,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
1,32343000,Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome.,"BACKGROUND


Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis.
AIM


To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS.
METHODS


Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score. The secondary outcomes were levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight.
RESULTS


The primary endpoint was not achieved in either group. However, there was a transient reduction in the mean IBS Symptom Severity Score in the FMT group at 12 weeks after treatment as compared to baseline (P = 0.01). The groups did not differ in the number of patients achieving clinical response at 12 weeks. In the FMT-treated patients, microbial composition had changed to resemble that of the donor and the stool water content decreased significantly compared to baseline. The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
CONCLUSIONS


FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.",2020,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","['irritable bowel syndrome', 'Forty-nine', 'IBS patients', 'Irritable bowel syndrome (IBS']","['FMT', 'faecal microbiota transplantation versus autologous placebo', 'faecal microbiota transplantation (FMT', 'autologous or allogenic FMT via colonoscopy']","['sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score', 'microbial composition', 'number of patients achieving clinical response', 'IBS symptoms', 'stool water content', 'levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight', 'depression score', 'mean IBS Symptom Severity Score']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",49.0,0.164282,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","[{'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Jalanka', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hartikainen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Mattila', 'Affiliation': 'Department of Infectious Diseases, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Hillilä', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Punkkinen', 'Affiliation': 'Department of Gastroenterology, Porvoo Hospital, Porvoo, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Koskenpato', 'Affiliation': 'Department of Gastroenterology, Aava Medical Centre, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Tillonen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Satokari', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Arkkila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15740']
2,32343462,Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial.,"BACKGROUND AND PURPOSE


Hereditary transthyretin (hATTR) amyloidosis causes progressive polyneuropathy resulting from transthyretin (TTR) amyloid deposition throughout the body, including the peripheral nerves. The efficacy and safety of inotersen, an antisense oligonucleotide inhibitor of TTR protein production, were demonstrated in the pivotal NEURO-TTR study in patients with hATTR polyneuropathy. Here, the long-term efficacy and safety of inotersen are assessed in an ongoing open-label extension (OLE) study.
METHODS


Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004). Efficacy assessments included the modified Neuropathy Impairment Score plus seven neurophysiological tests composite score (mNIS + 7), the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN) questionnaire total score and the Short-Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Safety and tolerability were also assessed.
RESULTS


Overall, 97% (135/139) of patients who completed NEURO-TTR enrolled in the OLE. Patients who received inotersen for 39 cumulative months in NEURO-TTR and the OLE continued to show benefit; patients who switched from placebo to inotersen in the OLE demonstrated improvement or stabilization of neurological disease progression by mNIS + 7, Norfolk QOL-DN and SF-36 PCS. No new safety concerns were identified. There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
CONCLUSION


Inotersen slowed disease progression and reduced deterioration of quality of life in patients with hATTR polyneuropathy. Early treatment with inotersen resulted in greater long-term disease stabilization than delayed initiation. Routine platelet and renal safety monitoring were effective; no new safety signals were observed.",2020,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
","['Patients With Hereditary Transthyretin Amyloidosis', 'Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004', 'patients with hATTR polyneuropathy']","['OLE', 'placebo']","['Safety and tolerability', 'risk for grade 4 thrombocytopenia or severe renal events', 'stabilization of neurologic disease progression by mNIS+7, Norfolk QOL-DN, and SF-36 PCS', 'disease progression and reduced deterioration of quality of life', 'greater long-term disease stabilization', 'modified Neuropathy Impairment Score +7 neurophysiologic tests composite score (mNIS+7), Norfolk Quality of Life-Diabetic Neuropathy questionnaire total score (Norfolk QOL-DN), and the Short Form 36 Health Survey (SF-36) Physical Component Summary score (PCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0250599,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Wang', 'Affiliation': 'University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM, Amyloidosis Referral Center, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Plante-Bordeneuve', 'Affiliation': 'CHU Henri Mondor, Creteil, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barroso', 'Affiliation': 'FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Center, IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Benson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gertz', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.14285']
3,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES


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


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


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


The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950']
4,32339499,"Effects of exogenous ghrelin administration and ghrelin receptor blockade, in combination with alcohol, on peripheral inflammatory markers in heavy-drinking individuals: Results from two human laboratory studies.","The ghrelin system has been garnering interest for its role in different neuropsychiatric disorders, including alcohol use disorder (AUD). Accordingly, targeting the ghrelin system is under investigation as a potential novel therapeutic approach. While alcohol provokes the immune system and inflammatory responses, ghrelin has potent immunomodulatory and anti-inflammatory properties. The present study aimed to shed light on the ""crosstalk"" between ghrelin and inflammation by examining the effects of exogenous ghrelin administration and ghrelin receptor blockade on peripheral inflammatory markers in the context of two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males, were enrolled. In the first randomized, crossover, double-blind, placebo-controlled human laboratory study, participants underwent two experimental paradigms - an intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo). A loading dose of intravenous ghrelin (3 mcg/kg) or placebo, followed by a continuous ghrelin (16.9 ng/kg/min) or placebo infusion was administered. In the second dose-escalating, single-blind, placebo-controlled human laboratory phase 1b study, participants were dosed with an oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge. Repeated blood samples were collected, and plasma concentrations of the following inflammatory markers were measured: C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α). During the IV-ASA experiment, significant drug × time interaction effects were observed for IL-6 (F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10. No significant drug × time interaction effects were observed during the IV-AC experiment, possibly because of its much shorter duration and/or smaller sample. Treatment with PF-5190457, compared to placebo, had no significant effect on the inflammatory markers investigated. In conclusion, a supraphysiologic pharmacological challenge with exogenous ghrelin in heavy-drinking individuals produced anti-inflammatory effects in the context of intravenous alcohol administration. On the contrary, ghrelin receptor blockade did not lead to any change in the inflammatory markers included in this study. Mechanistic studies are required to better understand the interaction between ghrelin, alcohol, and inflammatory processes.",2020,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","['heavy-drinking individuals', 'two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males']","['PF-5190457', 'oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge', 'intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo', 'placebo', 'exogenous ghrelin administration and ghrelin receptor blockade', 'intravenous ghrelin']","['blood concentrations of the anti-inflammatory cytokine IL-10', 'IL-6', 'C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α', 'time interaction effects', 'IL-10', 'blood concentrations of the proinflammatory cytokine IL-6']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0391690', 'cui_str': 'Growth Hormone Secretagogue Receptor'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.168388,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Munjal', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Abshire', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Brittney D', 'Initials': 'BD', 'LastName': 'Browning', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, United States; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, United States. Electronic address: lorenzo.leggio@nih.gov.'}]",Brain research,['10.1016/j.brainres.2020.146851']
5,32339953,Effects of cardiopulmonary resuscitation training for Mozambican nursing students in a low-resource setting: An intervention study.,"BACKGROUND


There is an increasing incidence of cardiovascular diseases in Africa. Nurses' ability to undertake cardiopulmonary resuscitation (CPR) can significantly impact the survival of patients who experience cardiac arrest.
OBJECTIVES


We aimed to identify the effects of CPR training among Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique.
DESIGN


A one-group pretest-posttest repeated-measures quasi-experimental design.
SETTING


Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.
PARTICIPANTS


Thirty-two RN-BSN students.
METHODS


Students' attitudes and self-efficacy on CPR were measured by self-reported questionnaires three times (before, immediately after, and 20 weeks post intervention). Data were analyzed by the paired t-test and repeated-measures analysis of variance.
RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001). Sociodemographic characteristics did not significantly differ throughout the measurements of attitude or self-efficacy.
CONCLUSIONS


CPR manikin training positively affected attitude and self-efficacy in CPR among RN-BSN nursing students immediately, but not at 20 weeks, after the training. There is a need for research to repeatedly quantify parameters in a controlled study at different intervals and develop an instructor-training course customized to Mozambique.",2020,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","['patients who experience cardiac arrest', 'Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique', 'Africa', 'Students', 'Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.\nPARTICIPANTS\n\n\nThirty-two RN-BSN students', 'Mozambican nursing students in a low-resource setting']","['CPR training', 'CPR manikin training', 'cardiopulmonary resuscitation (CPR', 'cardiopulmonary resuscitation training']","['attitude or self-efficacy', 'Attitude and self-efficacy scores', 'attitude and self-efficacy', 'attitudes and self-efficacy on CPR', 'Sociodemographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",,0.0139191,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","[{'ForeName': 'Jeonghui', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Department of Nursing, Bucheon University, 56 Sosa-Ro, Bucheon City 14774, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Ogcheol', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-Ro, Dongjak-Gu 06974, Seoul, Republic of Korea. Electronic address: leeoc@cau.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2020.104433']
6,32339910,Supporting patients and carers affected by pancreatic cancer: A feasibility study of a counselling intervention.,"PURPOSE


Patients with pancreatic cancer have extremely high unmet psychological and physical needs. Family carers of these patients have even higher levels of distress than patients. Our purpose was to assess the feasibility and acceptability of a counselling intervention in patients diagnosed with pancreatic cancer and their carers.
METHODS


We conducted a single-arm feasibility study of the PREPARES (Patients and RElatives affected by PAncreatic cancer: Referral, Education and Support) pilot intervention. Patient and carer participants received up to nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology. The intervention, informed by self-efficacy theory, involved components to assess and address care needs, and provide feedback to clinicians. Feasibility was measured using participation and retention rates. Participants completed semi-structured interviews at the end of the intervention about acceptability. These were analysed using thematic analysis.
RESULTS


Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively). Most participants (eight) completed all nine counselling sessions; two chose to receive fewer sessions and two were discontinued requiring more intensive psychiatric support. The intervention was highly acceptable. Participants unanimously preferred the telephone over video-conferencing and to receive counselling separately from their carer/patient. The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care. Suggested improvements included a welcome pack about their nurse-counsellor and that sessions should continue beyond nine sessions if required.
CONCLUSIONS


The PREPARES intervention was feasible and highly acceptable. This low-cost intervention provided much-needed support to people affected by this devastating disease.",2020,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","['patients and carers affected by pancreatic cancer', 'Patients with pancreatic cancer', 'Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively', 'patients diagnosed with pancreatic cancer and their carers', 'Patients and RElatives affected by PAncreatic cancer']","['nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology', 'counselling intervention', 'telephone over video-conferencing and to receive counselling separately from their carer/patient', 'PREPARES']","['feasibility and acceptability', ""nurse-counsellors' knowledge, care coordination and personalised care""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",12.0,0.0615602,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Chan', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Division of Cancer Services, Princess Alexandra Hospital, Metro South Hospital and Health Services, Brisbane, Australia.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Gordon', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Eastgate', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Aleksandra A', 'Initials': 'AA', 'LastName': 'Staneva', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Northfield', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Beebe', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wyld', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101729']
7,32339933,"Comments on ""A multicentre prospective randomized controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents"": Letter to the editor and authors reponse.",,2020,,['nursing home residents'],['static air mattress and alternating air pressure mattress'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}]",[],,0.0890545,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fagart', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France. Electronic address: willy.fagart@chu-nimes.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De La Bachelerie', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blot', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU de Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chevalier', 'Affiliation': 'Laboratoire De Biostatistique, Épidémiologie, Santé Publique, Informatique Médicale, CHU de Nîmes, 30029 Nîmes, France.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103547']
8,32341187,"Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder.","OBJECTIVE


To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO).
METHODS


Elderly (≥65 years) participants (n = 58) with insomnia were randomly allocated (Latin square design) to receive 5 treatments (5, 10, 25, and 50 mg daridorexant and placebo) during 5 treatment periods, each consisting of 2 treatment nights followed by a 5- to 12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.
RESULTS


Of 58 participants included, 67% were female, and the median age was 69 years (range 65-85 years). WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  p  < 0.0001 and  p  = 0.004, respectively); reductions were statistically significant for doses ≥10 mg compared with placebo (WASO: -32.0, -45.1, -61.4 minutes; LPS: -44.9, -43.8, -45.4 minutes for 10, 25, and 50 mg, respectively,  p  ≤ 0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group).
CONCLUSIONS


Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10-50 mg) in elderly people with insomnia disorder.
CLINICALTRIALSGOV IDENTIFIER


NCT02841709.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for elderly people with insomnia, daridorexant reduced WASO.",2020,"WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  ","['elderly people with insomnia, daridorexant reduced WASO', 'elderly people with insomnia disorder', 'elderly subjects with insomnia disorder', 'Of 58 participants included, 67% were female, and the median age was 69 years (range 65-85 years', 'Elderly (≥65 years) participants (n = 58) with insomnia']","['placebo', 'daridorexant', 'daridorexant and placebo', 'Daridorexant']","['Safety and tolerability', 'tolerated', 'WASO and LPS', 'absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography', 'fatigue, nasopharyngitis, gait disturbance, and headache']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",58.0,0.194625,"WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  ","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany. gzammit@clinilabs.com ydauvilliers@yahoo.fr.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany. gzammit@clinilabs.com ydauvilliers@yahoo.fr.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pain', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Sebök Kinter', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Mansour', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Kunz', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}]",Neurology,['10.1212/WNL.0000000000009475']
9,32346962,"Study of oral tranexamic acid, topical tranexamic acid, and modified Kligman's regimen in treatment of melasma.","BACKGROUND


Melasma is a pigmentary disorder affecting mainly face . Various treatment modalities available as topicals, superficial chemical peels and lasers but none till date gives promising results, until date quest for the best treatment modality is on.
AIM


To study the effect of oral and topical Tranexamic acid (TXA) and modified Kligman's regimen in treatment of melasma.
METHOD


Patients having melasma were enrolled after consent for voluntary participation. A detailed history and clinical examination was done. Total 60 patients were enrolled and randomized in three groups, 20 received oral TXA 250 mg twice daily, 20 topical TXA and 20 received modified Kligman's regimen for 8 weeks along with sunscreen MASI(Melasma area severity index) was calculated at baseline, at end of 4 & 8 weeks. MASI score was compared with that at the end of the study. Based on reduction in mean MASI the therapeutic response was graded. Pre and post treatment photographs was also compared. Statistical analysis done by using student square T test , ANOVA And TUKEY test.
RESULTS


Reduction in MASI score was observed in all the groups but greater reduction in MASI score with modified Kligman's regimen by 30% followed with oral TXA by 25% reduction and least with topical TXA by 5%.
CONCLUSION


Although modified Kligman's regimen is comparatively more efficient but due to its side effects in long term usage oral tranexamic acid could be a promising therapeutic approach for melasma.",2020,"RESULTS


Reduction in MASI score was observed in all the groups but greater reduction in MASI score with modified Kligman's regimen by 30% followed with oral TXA by 25% reduction and least with topical TXA by 5%.
","['Patients having melasma were enrolled after consent for voluntary participation', 'Total 60 patients', 'melasma']","[""oral TXA 250 mg twice daily, 20 topical TXA and 20 received modified Kligman's regimen"", ""oral and topical Tranexamic acid (TXA) and modified Kligman's regimen"", ""oral tranexamic acid, topical tranexamic acid, and modified Kligman's regimen"", 'topical TXA', 'oral TXA', 'tranexamic acid']",['MASI score'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0346591,"RESULTS


Reduction in MASI score was observed in all the groups but greater reduction in MASI score with modified Kligman's regimen by 30% followed with oral TXA by 25% reduction and least with topical TXA by 5%.
","[{'ForeName': 'Pooja J', 'Initials': 'PJ', 'LastName': 'Sahu', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}, {'ForeName': 'Adarsh Lata', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}, {'ForeName': 'Bhushan', 'Initials': 'B', 'LastName': 'Madke', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}, {'ForeName': 'Vikrant', 'Initials': 'V', 'LastName': 'Saoji', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}, {'ForeName': 'Sugat', 'Initials': 'S', 'LastName': 'Jawade', 'Affiliation': 'JNMC, DMIMS DU, Wardha, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13430']
10,32366996,One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy.,"BACKGROUND


Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance.
METHODS


This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >-10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36.
RESULTS


After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: -0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated.
CONCLUSIONS


Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance.",2020,No statistically significant difference was evident in any of the other secondary endpoints.,"['uncomplicated cataract surgery', 'cataract surgery', '808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia']","['levofloxacin/dexamethasone', 'dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone', 'levofloxacin plus dexamethasone']","['signs of inflammation in the anterior chamber', 'proportion of patients without anterior chamber inflammation', 'tolerated', 'Endophthalmitis', 'complete control of inflammation']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",808.0,0.284431,No statistically significant difference was evident in any of the other secondary endpoints.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Zazzo', 'Affiliation': 'University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Stanislao', 'Initials': 'S', 'LastName': 'Rizzo', 'Affiliation': 'A.O.U. Careggi, Florence, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Biagini', 'Affiliation': 'A.O.U. Careggi, Florence, Italy.'}, {'ForeName': 'Nadezhda', 'Initials': 'N', 'LastName': 'Pozdeyeva', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Maksim', 'Initials': 'M', 'LastName': 'Sinitsyn', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Verzin', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'De Rosa', 'Affiliation': 'A.O.R.N.A. Cardarelli, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Calabrò', 'Affiliation': 'A.O.R.N.A. Cardarelli, Naples, Italy.'}, {'ForeName': 'Teresio', 'Initials': 'T', 'LastName': 'Avitabile', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Bonfiglio', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fasce', 'Affiliation': 'University Vita-Salute, Milan, Italy.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Barraquer', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josè Lamarca', 'Initials': 'JL', 'LastName': 'Mateu', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': 'Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Carnovali', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. marino.carnovali@gmail.com.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Malyugin', 'Affiliation': 'Eye Microsurgery Federal State Institution, Moscow, Russian Federation.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Eye (London, England)",['10.1038/s41433-020-0869-1']
11,32279099,"Comment on the article ""The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial"".",,2020,,['total knee arthroplasty'],['tranexamic acid'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.103612,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, India. drsaubhikk@hotmail.com.'}]",International orthopaedics,['10.1007/s00264-020-04554-5']
12,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
13,32342118,[Reducing the risk of ipsilateral breast tumor relapse: external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery in patients with ductal carcinoma in situ and node-negative breast cancer : The multicentric randomised RAPID trial].,,2020,,['patients with ductal carcinoma in situ and node-negative breast cancer '],['external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery'],['risk of ipsilateral breast tumor relapse'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0433685,,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Souchon', 'Affiliation': ', Paul-Lincke-Ufer 8b, 10999, Berlin, Deutschland. r.souchon@t-online.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01609-9']
14,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
15,32347624,"Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double-blind, placebo-controlled clinical trial.","AIM


Irritability related to autism spectrum disorder (ASD) complicates the management of ASD patients at home and in clinical settings. In this randomized, double-blind, placebo-controlled clinical trial, we aimed to investigate the beneficial effects of adjuvant treatment with risperidone and sulforaphane in alleviating the irritability of children with ASD.
METHODS


Sixty drug-free patients aged 4-12 years were randomly assigned to one of two groups receiving risperidone plus sulforaphane or placebo. Risperidone was started with a daily dose of 0.25 mg in patients weighing <20 kg and 0.5 mg in those weighing ≥20 kg and increased stepwise to reach a maximum of 1 mg (<20 kg), 2.5 mg (20-45 kg), and 3.5 mg (>45 kg). Sulforaphane was administered at a daily dose of 50 μmol (≤45 kg) or 100 μmol (>45 kg). The participants were assessed with the Aberrant Behavior Checklist - Community Edition at baseline and at Weeks 5 and 10.
RESULTS


Compared to the placebo group, ASD patients in the sulforaphane group showed greater improvements in Irritability score (primary outcome measure; P = 0.001) and Hyperactivity/Noncompliance score (secondary outcome measure; P = 0.015), and significant Time × Treatment effect for Irritability (P = 0.007) and Hyperactivity/Noncompliance (P = 0.008). However, no difference was seen in improvements in the other secondary measures: Lethargy/Social Interaction score, Stereotypic Behavior score, Inappropriate Speech score, and frequency of adverse events.
CONCLUSION


Our results support the safety and efficacy of sulforaphane as an adjuvant to risperidone for improvement of irritability and hyperactivity symptoms in children with ASD.",2020,"However, no difference was seen in improvements in the other secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events.
","['Sixty drug-free patients, aged 4-12\u2009years', 'ASD children', 'autistic patients at home and clinical settings', 'Autism Spectrum Disorder', 'ASD patients']","['risperidone plus sulforaphane or placebo', 'risperidone and sulforaphane', 'sulforaphane', 'Sulforaphane', 'risperidone', 'Risperidone', 'placebo']","['hyperactivity/noncompliance', 'Aberrant Behavior Checklist-Community (ABC-C', 'irritability', 'secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events', 'irritability and hyperactivity symptoms']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.667456,"However, no difference was seen in improvements in the other secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Momtazmanesh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Amirimoghaddam-Yazdi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein Sanjari', 'Initials': 'HS', 'LastName': 'Moghaddam', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13016']
16,32344285,"Non-thyroidal illness syndrome, the hidden player in the septic shock induced myocardial contractile depression.","Septic shock causes high mortality in hospitalized patients, especially in those that develop myocardial dysfunction as an early complication. The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction). Most patients with septic shock have low serum thyroid hormone levels, a condition known as non-thyroidal illness syndrome. Thyroid hormones sustain myocardial contractility and energy metabolism. Septic shock non-thyroidal illness syndrome causes myocardial hypothyroidism, and hypothyroidism causes myocardial dysfunction that resembles the myocardial depression of septic shock. We hypothesize that the myocardial hypothyroidism that occurs during septic shock has a causal role in the pathogenesis of septic shock-induced myocardial dysfunction. Thyroid hormones regulate the calcium cycle, the phenotype of contractile proteins, adrenergic response, and fatty acid transport and oxidation in the cardiomyocytes. Therefore, the administration of levothyroxine and liothyronine to normalize thyroid hormones level within the myocardium will improve the myocardial function. The hypothesis will be tested in humans with septic shock by performing a prospective, randomized, placebo-controlled study to compare the effect of thyroid hormone administration with placebo on myocardial function. The proposed hypothesis challenges the idea that non-thyroidal illness syndrome is a beneficial response of the thyroid hormone axis to illness and that thyroid hormone replacement is detrimental. The administration of thyroid hormone in order to prevent and reverse myocardial hypothyroidism during septic shock is a new theoretical concept on thyroid hormone metabolism and action at the tissue level during non-thyroidal illness syndrome. If the hypothesis is correct, clinicians should consider cardiac hypothyroidism as a central player in myocardial dysfunction caused by sepsis. Thyroid hormone replacement should be incorporated into the armamentarium of septic shock treatment.",2020,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"['hospitalized patients', 'humans with septic shock']","['Thyroid hormone replacement', 'levothyroxine and liothyronine', 'thyroid hormone', 'placebo']","['low serum thyroid hormone levels', 'ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction', 'myocardial function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.205492,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Lado-Abeal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, Truman Medical Centers and University of Missouri Kansas City, MO, USA. Electronic address: joaquin.lado@tmcmed.org.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109775']
17,32279416,Preoperative evaluation of microvascular invasion with circulating tumour DNA in operable hepatocellular carcinoma.,"BACKGROUND & AIMS


Microvascular invasion (MVI) is a critical prognostic factor for operable hepatocellular carcinoma (HCC). This study aimed to explore the performance of circulating tumour DNA (ctDNA) in evaluating MVI status preoperatively.
METHODS


Seventy-three HCC patients were enrolled and randomly divided into a training cohort and a validation cohort in a 2:1 ratio, and preoperative blood and surgical tissue samples were obtained. Genomic alterations were analysed using targeted deep sequencing with a 1021-gene panel.
RESULTS


In training cohort, 260 somatic mutations were identified in 40 blood samples (81.6%). CtDNA mutation was verified in paired tissue sample in 39 patients (97.5%). In univariate analysis, ctDNA allele frequency (AF) and largest tumour diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis. With the cut-off value of 0.83%, ctDNA AF determined the presence of MVI with the sensitivity of 89.7% and specificity of 80.0% in the training cohort, and the sensitivity of 78.6% and the specificity of 81.8% in the validation cohort. In preoperative evaluation, ctDNA AF, AFP level and BCLC staging were associated with recurrence-free survival in both univariate and multivariate analysis.
CONCLUSIONS


CtDNA can serve as an independent risk factor of MVI for operable HCC and help determining precise treatment strategies. The integration of ctDNA in the management of operable HCC may achieve better clinical outcomes.",2020,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","['operable hepatocellular carcinoma (HCC', 'Seventy-three HCC patients', 'operable hepatocellular carcinoma']",[],"['recurrence-free survival', 'ctDNA AF, AFP level and BCLC staging']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0017270', 'cui_str': 'Gene frequency'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]",260.0,0.0294222,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Goldstein', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Lianpeng', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Long', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qiongzhi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Ledu', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14463']
18,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677']
19,32344198,Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.,"BACKGROUND


The bile acid (BA) pathway plays a role in regulation of food intake and glucose metabolism, based mainly on findings in animal models. Our aim was to determine whether the BA pathway is altered and correctable in human obesity and diabetes.
METHODS


We conducted 3 investigations: 1) BA receptor pathways were studied in NCI-H716 enteroendocrine cell (EEC) line, whole human colonic mucosal tissue and in human colonic EEC isolated by Fluorescence-activated Cell Sorting (ex vivo) from endoscopically-obtained biopsies colon mucosa; 2) We characterized the BA pathway in 307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a placebo-controlled, double-blind, randomised, 28-day trial, we studied the effect of ileo-colonic delivery of conjugated BAs (IC-CBAS) on glucose metabolism, incretins, and lipids, in participants with obesity and diabetes.
FINDINGS


Human colonic GLP-1-producing EECs express TGR5, and upon treatment with bile acids in vitro, human EEC differentially expressed GLP-1 at the protein and mRNA level. In Ussing Chamber, GLP-1 release was stimulated by Taurocholic acid in either the apical or basolateral compartment. FGF19 was decreased in obesity and diabetes compared to controls. When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide. Increase in faecal BA was associated with weight loss and with decreased fructosamine.
INTERPRETATIONS


In humans, BA signalling machinery is expressed in colonic EECs, deficient in obesity and diabetes, and when stimulated with IC-CBAS, improved glucose homeostasis. ClinicalTrials.gov number, NCT02871882, NCT02033876.
FUNDING


Research support and drug was provided by Satiogen Pharmaceuticals (San Diego, CA). AA, MC, and NFL report grants (AA- C-Sig P30DK84567, K23 DK114460; MC- NIH R01 DK67071; NFL- R01 DK057993) from the NIH. JR was supported by an Early Career Grant from Society for Endocrinology.",2020,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","['human obesity and diabetes', 'participants with obesity and diabetes', '307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a']","['placebo, IC-CBAS', 'conjugated bile acids', 'ileo-colonic delivery of conjugated BAs (IC-CBAS', 'FGF19', 'placebo']","['glucose homeostasis', 'weight loss', 'faecal BA', 'obesity and diabetes', 'postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",307.0,0.064704,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Calderon', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Rievaj', 'Affiliation': 'University of Cambridge, UK; Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Inuk', 'Initials': 'I', 'LastName': 'Zandvakili', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Linker-Nord', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Gedulin', 'Affiliation': 'Satiogen Pharmaceuticals, San Diego, CA, United States.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States. Electronic address: acosta.andres@mayo.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102759']
20,32344201,Continuous postoperative pericardial flushing method versus standard care for wound drainage after adult cardiac surgery: A randomized controlled trial.,"BACKGROUND


Excessive bleeding, incomplete wound drainage, and subsequent accumulation of blood and clots in the pericardium have been associated with a broad spectrum of bleeding-related complications after cardiac surgery. We developed and studied the continuous postoperative pericardial flushing (CPPF) method to improve wound drainage and reduce blood loss and bleeding-related complications.
METHODS


We conducted a single-center, open-label, ITT, randomized controlled trial at the Academic Medical Center Amstserdam. Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD) were randomly assigned (1:1) to receive CPPF method or standard care. The primary outcome was actual blood loss after 12-hour stay in the intensive care unit (ICU). Secondary outcomes included bleeding-related complications and clinical outcome after six months follow-up.
FINDINGS


Between May 2013 and February 2016, 170 patients were randomly allocated to CPPF method (study group; n = 80) or to standard care (control group; n = 90). CPPF significantly reduced blood loss after 12-hour stay in the ICU (-41%) when compared to standard care (median differences -155 ml, 95% confidence interval (CI) -310 to 0; p=≤0·001). Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively. At discharge from hospital, patients in the study group were less likely to have pleural effusion in a surgically opened pleural cavity (22% vs. 36%; p = 0·043).
INTERPRETATION


Our study results indicate that CPPF is a safe and effective method to improve chest tube patency and reduce blood loss after cardiac surgery. Larger trials are needed to draw final conclusions concerning the effectiveness of CPPF on clinically relevant outcomes.",2020,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","['wound drainage after adult cardiac surgery', 'Between May 2013 and February 2016, 170 patients', 'Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD']","['CPPF', 'CPPF method or standard care', 'Continuous postoperative pericardial flushing method versus standard care', 'CPPF method (study group; n\u202f=\u202f80) or to standard care (control group; n\u202f=\u202f90']","['actual blood loss after 12-hour stay in the intensive care unit (ICU', 'Cardiac tamponade and reoperation for bleeding', 'pleural effusion', 'bleeding-related complications and clinical outcome after six months follow-up', 'blood loss']","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553700', 'cui_str': 'Actual blood loss'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007177', 'cui_str': 'Cardiac tamponade'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",170.0,0.171937,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Diephuis', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Electronic address: e.c.diephuis@amsterdamumc.nl.'}, {'ForeName': 'Corianne', 'Initials': 'C', 'LastName': 'de Borgie', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tomšič', 'Affiliation': 'Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Winkelman', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Wim Jan', 'Initials': 'WJ', 'LastName': 'van Boven', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Berto', 'Initials': 'B', 'LastName': 'Bouma', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Juffermans', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koolbergen', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102744']
21,32343890,Olaparib for Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.
METHODS


We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.
RESULTS


In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.
CONCLUSIONS


In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"['Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone', 'patients with prostate and other cancers', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving', 'Metastatic Castration-Resistant Prostate Cancer']","['PARP inhibitor olaparib', 'enzalutamide or abiraterone', ""olaparib or the physician's choice of enzalutamide or abiraterone (control"", 'Olaparib']","['objective response rate and the time to pain progression', 'Anemia and nausea', 'median overall survival', 'imaging-based progression-free survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",245.0,0.264475,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1911440']
22,32343963,Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial.,"BACKGROUND


Noninvasive ventilation (NIV) is an effective form of treatment in obesity hypoventilation syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype.
RESEARCH QUESTION


Is NIV effective in OHS without severe OSA phenotype?
STUDY DESIGN AND METHODS


In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index < 30 events/h (ie, no severe OSA) to NIV or lifestyle modification (control group) using simple randomization through an electronic database. The primary end point was hospitalization days per year. Secondary end points included other hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, BP, quality of life, sleepiness, and other clinical symptoms. Both investigators and patients were aware of the treatment allocation; however, treating physicians from the routine care team were not aware of patients' enrollment in the clinical trial. The study was stopped early in its eighth year because of difficulty identifying patients with OHS without severe OSA. The analysis was performed according to intention-to-treat and per-protocol principles and by adherence subgroups.
RESULTS


Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco 2 , pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms.
INTERPRETATION


In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov.",2020,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","['49 patients in the NIV group and 49 in the control group were randomized and 48 patients in each group were analyzed', '98 stable ambulatory patients with untreated OHS and apnea-hypopnea index <30 events/hour (i.e., no severe OSA) to', 'obesity hypoventilation syndrome (OHS) with severe obstructive sleep apnea (OSA', 'Obesity Hypoventilation Syndrome without Severe Obstructive Sleep Apnea', 'stable ambulatory patients with OHS without severe OSA', 'OHS patients without severe OSA phenotype']","['Long-term Noninvasive Ventilation', 'Noninvasive ventilation (NIV', 'NIV or lifestyle modification (control group) using simple randomization through an electronic database']","['hospitalization days/year', 'PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness', 'hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, blood pressure, quality of life, sleepiness and other clinical symptoms', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0031880', 'cui_str': 'Extreme obesity with alveolar hypoventilation'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0556972', 'cui_str': 'days/year'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",98.0,0.143898,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Spain. Electronic address: fmasa@separ.es.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Maria Á', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Spain; Respiratory Department, Virgen del Puerto Hospital, Plasencia, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Gomez de Terreros', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gomez-Garcia', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, IIS Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Miguel Servet Hospital, Zaragoza, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': ""CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Doce de Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Alava University Hospital IRB, Vitoria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Spain; Nursing Department, Extremadura University, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Department of Medicine/Pulmonary and Critical Care, University of Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.03.068']
23,32352341,"Sixteen weeks of testosterone with or without evoked resistance training on protein expression, fiber hypertrophy and mitochondrial health after spinal cord injury.","We investigated the effects of testosterone replacement therapy (TRT) with and without evoked resistance training (RT) on protein expression of key metabolic and hypertrophy regulators, muscle fiber cross-sectional area (CSA), and markers of mitochondrial health after spinal cord injury (SCI). Twenty-two men with chronic motor complete SCI were randomly assigned to either TRT + RT ( n  = 11) or TRT ( n  = 11) for 16 wk. TRT + RT men underwent twice weekly progressive RT using electrical stimulation with ankle weights. TRT was administered via testosterone patches (2-6 mg/day). Muscle biopsies were obtained before and after 16 wk from the right vastus lateralis. Expression of proteins associated with oxidative muscles and mechanical loading (PGC-1α and FAK), muscle hypertrophy (total and phosphorylated Akt, total and phosphorylated mTOR), and cellular metabolism (total and phosphorylated AMPK and GLUT4) were evaluated. Immunohistochemistry analysis was performed to measure fiber CSA and succinate dehydrogenase (SDH) activity as well as mitochondrial citrate synthase (CS) activity and complex III (CIII) activities. TRT + RT demonstrated a robust 27.5% increase in average fiber CSA compared with a -9% decrease following TRT only ( P  = 0.01). GLUT4 protein expression was elevated in the TRT + RT group compared with TRT only ( P  = 0.005). Total Akt ( P  = 0.06) and phosphorylated Akt Ser 389  ( P  = 0.049) were also elevated in the TRT + RT group. Mitochondrial activity of SDH ( P  = 0.03) and CS ( P  = 0.006) increased in the TRT + RT group, with no changes in the TRT-only group. Sixteen weeks of TRT with RT resulted in fiber hypertrophy and beneficial changes in markers of skeletal muscle health and function. NEW & NOTEWORTHY  Fiber cross-sectional area (CSA), protein expression, mitochondrial citrate synthase (CS), and succinate dehydrogenase (SDH) were measured following 16 wk of low-dose testosterone replacement therapy (TRT) with and without electrically evoked resistance training (RT) in men with spinal cord injury (SCI). Fiber CSA and protein expression of total GLUT4, total Akt, and phosphorylated Akt increased following TRT + RT but not in the TRT-only group. Mitochondrial CS and SDH increased after TRT + RT but not in TRT-only group.",2020,"Expression of proteins associated with oxidative muscles and mechanical loading (PGC1α and FAK), muscle hypertrophy","['after spinal cord injury (SCI', 'Twenty-two men with chronic motor complete SCI']","['testosterone with or without resistance training', 'TRT was administered via testosterone patches', 'TRT', 'TRT+RT', 'TRT with RT', 'testosterone replacement therapy (TRT) with and without evoked resistance training (RT']","['Protein Expression, Fiber Hypertrophy and Mitochondrial Health', 'fiber CSA, and succinate dehydrogenase (SDH) activity as well as mitochondrial citrate synthase (CS) activity and complex III (CIII)activities', 'skeletal muscle health and function', 'oxidative muscles and mechanical loading (PGC1α and FAK), muscle hypertrophy', 'Total Akt', 'protein expression of key metabolic and hypertrophy regulators, muscle fiber cross sectional area (CSA) and markers of mitochondrial health', 'average fiber CSA', 'Mitochondrial activity of SDH', 'GLUT4 protein expression', 'total and phosphorylated AKT, total and phosphorylated mTOR), and cellular metabolism (total and phosphorylated AMPK and GLUT4']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3544168', 'cui_str': 'Complete spinal cord injury'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038615', 'cui_str': 'Succinate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C1176474', 'cui_str': 'Ubiquinol-cytochrome-c reductase'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0166441', 'cui_str': 'Insulin-Responsive Glucose Transporter'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}]",22.0,0.0296207,"Expression of proteins associated with oxidative muscles and mechanical loading (PGC1α and FAK), muscle hypertrophy","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Graham', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Medical Service, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Rivers', 'Affiliation': 'Surgery Service, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Service, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Lesnefsky', 'Affiliation': 'Medical Service, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cardozo', 'Affiliation': 'Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00865.2019']
24,32348280,A Pedometer-Guided Physical Activity Intervention for Obese Pregnant Women (the Fit MUM Study): Randomized Feasibility Study.,"BACKGROUND


Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to both mother and child. A major contributor to both prepregnancy obesity and excessive GWG is physical inactivity; however, past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution for increasing activity levels in this population.
OBJECTIVE


This initial feasibility randomized controlled trial aimed to test a pedometer-based intervention to increase activity and reduce excessive GWG in pregnant women.
METHODS


We supplied 30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups: control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program). Feasibility outcomes included participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity. Activity outcomes (step counts and active minutes) were analyzed using linear mixed models and generalized estimating equations.
RESULTS


A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30; 2 withdrawals and 1 stillbirth); 27 participants thus completed the study. Mean BMI in all groups was ≥35 kg/m 2 . Mean (SD) percentage of missing data days were 23.4% (20.6%), 39.5% (32.4%), and 21.1% (16.0%) in control, app group, and app-coach group patients, respectively. Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration. There was a mean decrease of 7.8 steps/day for each increase in gestation day over the study period (95% CI 2.91 to 12.69, P=.002).
CONCLUSIONS


Activity data syncing with a personal smartphone is feasible in a cohort of pregnant women with obesity. However, our results do not support a future definitive study in its present form. Recruitment and retention rates were adequate, as was activity data syncing to participants' smartphones. A follow-up interventional trial seeking to reduce GWG and improve activity in this population must focus on improving compliance with activity data recording and behavioral interventions delivered.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884.",2020,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","['pregnant women with obesity', 'women who are already overweight', '30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups', 'Obese Pregnant Women', 'A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30, 2 withdrawals and 1 stillbirth); 27 participants thus completed the study', 'pregnant women']","['pedometer-based intervention', 'Pedometer-Guided Physical Activity Intervention', ""control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program""]","['Estimated mean baseline activity levels', 'Recruitment and retention rates', 'maternal weight gain and activity levels', 'Mean BMI', 'Mean (SD) percentage of missing data days', 'activity levels', 'participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity', 'Activity outcomes (step counts and active minutes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}]",30.0,0.0752825,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","[{'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Darvall', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mohamed Nusry', 'Initials': 'MN', 'LastName': 'Nazeem', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Cheryce L', 'Initials': 'CL', 'LastName': 'Harrison', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Chennelle', 'Initials': 'C', 'LastName': 'Mendoza', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harrap', 'Affiliation': 'Melbourne Epicentre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Teale', 'Affiliation': ""Department of Women's and Children's Services, Western Health, Melbourne, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hessian', 'Affiliation': 'Department of Anaesthesia and Pain Management, Western Health, Melbourne, Australia.'}]",JMIR mHealth and uHealth,['10.2196/15112']
25,32352877,"Analysis of pain symptoms, flexibility and hydroxyproline concentration in individuals with low back pain submitted to Global Postural Re-education and stretching.","Aim:  To evaluate pain, flexibility and hydroxyproline (HP) urinary levels in patients with nonspecific low back pain submitted to Global Postural Re-education (GPR) and stretching.  Materials &   methods:  39 individuals who reported low back pain were randomly assigned to a group submitted to GPR (GPRG) or stretching exercises (SG) for 8 weeks. Pain and flexibility were assessed using the Borg CR10 scale and goniometry, respectively.  Results:  The GPR group showed a significant reduction in the HP levels and significant improvements in flexibility after the intervention when compared with SG. Both groups presented a significant reduction in HP and pain after the intervention.  Conclusion:  Both interventions were effective in the treatment of low back pain. However, the GPR method presented better responses than stretching.",2020,The GPR group showed a significant reduction in the HP levels and significant improvements in flexibility after the intervention when compared with SG.,"['individuals with low back pain submitted to Global Postural Re-education and stretching', '39 individuals who reported low back pain', 'patients with nonspecific low back pain submitted to Global Postural Re-education (GPR) and stretching']",['GPR (GPRG) or stretching exercises (SG'],"['HP and pain', 'pain symptoms, flexibility, and hydroxyproline concentration', 'pain, flexibility and hydroxyproline (HP) urinary levels', 'flexibility', 'HP levels', 'Pain and flexibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085498', 'cui_str': 'Gram-positive bacillus'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0020388', 'cui_str': 'Hydroxyproline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",39.0,0.0461654,The GPR group showed a significant reduction in the HP levels and significant improvements in flexibility after the intervention when compared with SG.,"[{'ForeName': 'Frederico Pecorone', 'Initials': 'FP', 'LastName': 'Matos', 'Affiliation': 'Laboratory of Exercise Physiology, Estácio de Sá University, Cabo Frio, Rio de Janeiro, Brazil.'}, {'ForeName': 'Estélio Henrique Martin', 'Initials': 'EHM', 'LastName': 'Dantas', 'Affiliation': 'Laboratory of Biosciences of Human Motricity, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flávio Boechat', 'Initials': 'FB', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratory of Exercise Physiology, Estácio de Sá University, Cabo Frio, Rio de Janeiro, Brazil.'}, {'ForeName': 'Juliana Brandão Pinto', 'Initials': 'JBP', 'LastName': 'de Castro', 'Affiliation': 'Postgraduate Program in Exercise & Sport Sciences, Institute of Physical Education & Sports, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mario Cezar de S Costa', 'Initials': 'MCSC', 'LastName': 'Conceição', 'Affiliation': 'Postgraduate Program in Exercise & Sport Sciences, Institute of Physical Education & Sports, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rodolfo de Alkmim Moreira', 'Initials': 'RAM', 'LastName': 'Nunes', 'Affiliation': 'Postgraduate Program in Exercise & Sport Sciences, Institute of Physical Education & Sports, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rodrigo Gomes de Souza', 'Initials': 'RGS', 'LastName': 'Vale', 'Affiliation': 'Laboratory of Exercise Physiology, Estácio de Sá University, Cabo Frio, Rio de Janeiro, Brazil.'}]",Pain management,['10.2217/pmt-2019-0053']
26,32353619,Suture Tape Reduces Quadriceps Tendon Repair Gap Formation Compared With High-Strength Suture: A Cadaveric Biomechanical Analysis.,"PURPOSE


To compare the biomechanical differences between quadriceps tendon (QT) repair with high-strength suture (HSS) versus suture tape (ST) with varying number of suture passes.
METHODS


In total, 28 fresh-frozen QTs were randomized into 2 groups: (1) HSS; or (2) ST; specimens were then further randomized into subgroups of either 4 or 6 suture passes. Specimens were secured within a materials testing system and a 150-N preload was applied for 10 seconds followed by a cyclic loading protocol between 50 N and 250 N for 1000 cycles. Video was used to follow tracking markers used to calculate the magnitude of tendon displacement. Two-way univariate analysis of variance was used to determine the effect of suture type and passes on the displacement after preloading and mixed repeated-measures analysis of variance was used to determine the effect of suture type and passes on displacement following cyclic loading.
RESULTS


There were large increases in displacement following the preload across all conditions (7.82 ± 3.64 mm), with no statistically significant differences between groups. There was a significant difference in the mean (± standard deviation) displacement between the ST (5.24 ± 2.82 mm) and HSS (7.93 ± 2.91 mm) starting at 200 cycles, which became more pronounced with successive testing out to 1000 cycles (P = .021). There were no significant difference with respect to the number of suture or tape passes.
CONCLUSIONS


Following preloading at 150 N, significant displacement occurred in both QT repair groups. ST demonstrated significantly less displacement than HSS under cyclic loading and had greater ultimate failure loads.
CLINICAL RELEVANCE


When performing QT repair, emphasis should be placed on appropriate pretensioning of sutures to at least 150 N before knot-tying. In addition, where available, ST should be used over HSS to reduce further cyclic elongation and improve ultimate failure loads.",2020,ST demonstrated significantly less displacement than HSS under cyclic loading and had greater ultimate failure loads.conclusion,['28 fresh-frozen QTs'],"['quadriceps tendon (QT) repair with high-strength suture (HSS) versus suture tape (ST', 'HSS; or ii) ST', 'High Strength Suture', 'Suture Tape']","['number of suture or tape passes.results', 'Quadriceps Tendon Repair Gap Formation', 'ultimate failure loads.conclusion', 'mean (±SD) displacement']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}]","[{'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0547072', 'cui_str': 'Repair of quadriceps'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",,0.0324435,ST demonstrated significantly less displacement than HSS under cyclic loading and had greater ultimate failure loads.conclusion,"[{'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Roessler', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Burkhart', 'Affiliation': 'Lawson Health Research Institute, Mechanical and Materials Engineering, Western University, London Ontario, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Degen', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada. Electronic address: Ryan.degen@lhsc.on.ca.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.04.020']
27,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
28,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
29,32348263,Effect of an mHealth Intervention Using a Pedometer App With Full In-Person Counseling on Body Composition of Overweight Adults: Randomized Controlled Weight Loss Trial.,"BACKGROUND


In clinical practice, it is difficult to convey the benefits of sustained physical activity to adult patients with excess weight or obesity. For this purpose, a goal-setting walking prescription may be an effective strategy.
OBJECTIVE


This study aimed to determine the efficacy of the intervention of a pedometer app in setting a goal to reach 10,000 steps per day in adults.
METHODS


Overweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2) were randomized to one of two conditions (control or intervention). Both groups downloaded a pedometer app that recorded their daily step counts and were given a daily walking goal of 10,000 steps. Subjects participated in a 24-week in-person behavioral weight control program and were asked to monitor their daily levels using the pedometer app. Baseline data were recorded and followed up weekly. Only the intervention group had structured information delivery, a personalized physical activity prescription, and follow-up on number of steps per day.
RESULTS


The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized β coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
CONCLUSIONS


These results could have implications for improving self-monitoring in overweight adults during periods of weight loss. Health professionals should analyze the implementation of tools that permit them to prescribe, follow up, and encourage the achievement of a goal of physical activity in overweight or obese patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03845478; https://clinicaltrials.gov/ct2/show/NCT03845478.",2020,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","['Overweight Adults', 'Overweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2', 'adults', 'overweight or obese patients', 'adult patients with excess weight or obesity']",['mHealth Intervention Using a Pedometer App With Full'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],,0.0631852,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernández-Reyes', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cámara-Martos', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno-Rojas', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}]",JMIR mHealth and uHealth,['10.2196/16999']
30,32350598,Comparison of aspirating pipettes and hysteroscopy with curettage.,"PURPOSE


In this prospective study, endometrial biopsy by pipette was compared with hysteroscopy with curettage in patients with an abnormal uterine bleeding (ABU) (hypermenorrhea, intermediate bleeding, continuous bleeding, postmenopausal bleeding) and patients with a sonographically abnormal endometrium.
METHODS


176 patients were included. The pipette samples were taken during the usual planned procedure under general anaesthesia. Thereafter, the planned hysteroscopy with curettage was completed. The study was performed as a double-blind study. The obtained histologies (of pipelle and curettage) were sent separately to the same pathologist. The pipelle material was encoded by a specific number without any patient data.
RESULTS


In 97% of the cases using the biopsy with pipette were obtained an adequate sample. The biopsy with pipette had a sensitivity and specificity of 100% in the diagnosis of endometrial carcinoma and atypical hyperplasia. Pipette showed a significantly lower accuracy with a sensitivity of 28% in the diagnosis of endometrial hyperplasia without atypia. Pipette showed the lowest sensitivity for polyps, myomas and atrophic endometrium.
CONCLUSION


The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma. In the case of sonographically definable findings (polyp, myoma), hysteroscopy with curettage is preferred.",2020,"The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma.","['176 patients were included', 'patients with an abnormal uterine bleeding (ABU) (hypermenorrhea, intermediate bleeding, continuous bleeding, postmenopausal bleeding) and patients with a sonographically abnormal endometrium']","['aspirating pipettes and hysteroscopy with curettage', 'hysteroscopy with curettage']","['sensitivity and specificity', 'lowest sensitivity for polyps, myomas and atrophic endometrium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}]","[{'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0182301', 'cui_str': 'Micropipette'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0334192', 'cui_str': 'Atrophic endometrium'}]",176.0,0.0205982,"The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piriyev', 'Affiliation': 'Clinic for Gynecology and Obstetrics of the Evangelical Hospital Cologne Weyertal Academic Teaching Hospital of the University of Cologne, Cologne, Germany. piriyev.elvins@gmail.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mellin', 'Affiliation': 'Practice for Pathology and Cytology Cologne Weyertal, Cologne, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Römer', 'Affiliation': 'Clinic for Gynecology and Obstetrics of the Evangelical Hospital Cologne Weyertal Academic Teaching Hospital of the University of Cologne, Cologne, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05551-0']
31,32353645,Effectiveness of simulation learning program for mastering public health nursing skills to enhance strength of community: A quasi-experimental design.,"PURPOSE


The purpose of this study is to develop a simulation learning program for mastering public health nursing skills to enhance strength of community, and to verify its effectiveness.
METHODS


The program is one-day session to master the skills from three exercises. This study adopts a quasi-experimental design. We selected unbiased 34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2. Three tools were used to measure the required outcome. For the outcome evaluation, we calculated the changes in the mean value of each tool between pre and post 1 and between pre and post 2, and compared them between the two groups.
RESULTS


The change of intervention group in the total score at the post 1 stage from the pre stage was significantly higher than control group regarding each of the scales (P < .05).
CONCLUSIONS


The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.",2020,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"['mastering public health nursing skills to enhance strength of community', '34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2']",['simulation learning program'],['total score'],"[{'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0034023', 'cui_str': 'Nursing, Public Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439547', 'cui_str': 'Points in time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.015403,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Okamoto', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan. Electronic address: reiko@sahs.med.osaka-u.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Gouda', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koide', 'Affiliation': 'Faculty of Nursing, Shitennouji University, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Tokimasa', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Kageyama', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Iwamoto', 'Affiliation': 'Faculty of Nursing, Kobe City College of Nursing, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Shiomi', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Kusano', 'Affiliation': 'Faculty of Nursing, Osaka Medical College, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Kiya', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Aoki', 'Initials': 'A', 'LastName': 'Tada', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Hanayo', 'Initials': 'H', 'LastName': 'Koetaka', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}]",Nurse education today,['10.1016/j.nedt.2020.104432']
32,32348815,Addressing Chemophobia: Informational versus affect-based approaches.,"This study investigated the effect of two communication strategies (informational and affect-based) in reducing chemophobia, the irrational fear of chemicals. In an online experiment, participants (N = 448) were randomly assigned to one of three groups (""control"", ""knowledge"", or ""affect"" group). The following dependent variables were assessed: chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products. The results showed that only the informational approach, which conveys knowledge of basic toxicological principles, significantly decreased chemophobia and the preference for natural substitutes in consumer products. The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia. This suggested that the provision of relevant information about basic toxicological principles is a more effective strategy than merely addressing laypeople's affect towards chemicals to reduce chemophobia. Relevant knowledge could be taught in schools or disseminated by toxicologists and scientists who are trusted by the public.",2020,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.",['participants (N\u202f=\u202f448'],[],"['chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products']",[],[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205472', 'cui_str': 'Toxicologic'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0596381', 'cui_str': 'Consumer product'}]",448.0,0.0278971,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saleh', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland. Electronic address: rita.saleh@hest.ethz.ch.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111390']
33,32353419,"Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy.","BACKGROUND


A significant subset of breast cancer survivors experience cognitive difficulties in attention and memory, which persist for years following treatment. Transcranial direct current stimulation (tDCS) has been shown to be effective in improving working memory, attention, processing speed, and other cognitive functions in both healthy and clinical populations. To date, no studies have examined tDCS for rehabilitation of cancer-related cognitive dysfunction.
OBJECTIVE/HYPOTHESIS


We aimed to provide preliminary evidence for feasibility, tolerability, acceptability, and efficacy of tDCS in improving performance on a measure of sustained attention.
METHODS


In a within-subjects design, 16 breast cancer survivors underwent 2 consecutive days of active tDCS over the prefrontal cortex, and 2 days of sham tDCS, counterbalanced for order of stimulation condition, while performing a continuous performance test.
RESULTS


Stimulation was feasible and tolerable, with 89% of participants completing all sessions, and none reporting more than mild to moderate discomfort. Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p < 0.05). Furthermore, the effect of stimulation on standard errors of reaction times differed by inter-stimulus interval (ISI): for 1 and 2 s ISIs, there was no significant difference in performance between sham and active tDCS conditions, but for 4 s ISIs, stimulation improved variability in response times relative to sham (p < 0.05).
CONCLUSIONS


Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer-related cognitive dysfunction.",2020,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","['survivors with cancer-related cognitive dysfunction', 'breast cancer survivors', '16 breast cancer survivors']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS', 'transcranial direct current stimulation']","['feasibility, tolerability, acceptability, and efficacy', 'standard errors of reaction times']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.118383,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Gaynor', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA. Electronic address: gaynora@mskcc.org.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pergolizzi', 'Affiliation': 'Universitat Internacional de Catalunya, School of Medicine and Health Sciences, Barcelona, Spain.'}, {'ForeName': 'Yesne', 'Initials': 'Y', 'LastName': 'Alici', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Katrazyna', 'Initials': 'K', 'LastName': 'McNeal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.04.013']
34,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
35,32347270,Prospective randomized trial evaluating blood and prostate tissue concentrations of green tea polyphenols and quercetin in men with prostate cancer.,"We evaluated if chronic consumption of quercetin (Q) with green tea extract (GTE) enhances the bioavailability of GT polyphenols (GTPs) and reduces methylation activity as previously observed in mouse xenograft tumors. In this prospective, randomized, parallel design, placebo controlled study, thirty-one men with prostate cancer consumed daily 1 gram of GTE (830 mg of GTP) with 800 mg of Q (GT + Q) or placebo (GT + PL) for four weeks before prostatectomy. First morning voided urine was collected at baseline, 3 weeks and the day of surgery, and prostate tissue on the day of surgery. In week 3, plasma concentration of GTPs and Q was measured in blood collected before and 2 hours after the morning dose. Prostate tissue epigallocatechin gallate (EGCG) and epicatechin gallate (ECG) were detected in 67 and 93% of participants in the GT + Q group and 75 and 94% of participants in the GT + PL group. Q was increased 14-fold, 12-fold and 4.5-fold in plasma, urine, and prostate tissue, respectively, in the GT + Q compared to the GT + PL-group. There was a trend for decreased EGC levels in urine collected prior to prostatectomy in the GT + Q compared to GT + PL-group (p = 0.053). Plasma epigallocatechin (EGC) showed a trend to increase (p = 0.066) two hours after capsule intake in the GT + Q vs. the GT + PL-group. There was no significant difference between the groups in GTP content or methylation activity in prostate tissue or RBCs. No liver toxicity was observed. Although our findings are suggestive, further studies are warranted evaluating if Q alters GTP metabolism.",2020,There was a trend for decreased EGC levels in urine collected prior to prostatectomy in the GT + Q compared to GT + PL-group (p = 0.053).,"['thirty-one men with prostate cancer', 'men with prostate cancer']","['GTE (830 mg of GTP) with 800 mg of Q (GT + Q) or placebo (GT + PL', 'green tea polyphenols and quercetin', 'quercetin (Q) with green tea extract (GTE', 'placebo']","['Prostate tissue epigallocatechin gallate (EGCG) and epicatechin gallate (ECG', 'Plasma epigallocatechin (EGC', 'EGC levels', 'liver toxicity', 'bioavailability of GT polyphenols (GTPs', 'GTP content or methylation activity in prostate tissue or RBCs', 'plasma concentration of GTPs and Q', 'methylation activity']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C4517889', 'cui_str': '830'}, {'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0059422', 'cui_str': 'epicatechin-3-gallate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",31.0,0.0377436,There was a trend for decreased EGC levels in urine collected prior to prostatectomy in the GT + Q compared to GT + PL-group (p = 0.053).,"[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Henning', 'Affiliation': 'Center for Human Nutrition David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA. shenning@mednet.ucla.edu.'}, {'ForeName': 'Piwen', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ru-Po', 'Initials': 'RP', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Trang', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Husari', 'Affiliation': ''}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Grojean', 'Affiliation': ''}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Ly', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heber', 'Affiliation': ''}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Grogan', 'Affiliation': ''}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': ''}]",Food & function,['10.1039/d0fo00565g']
36,32348624,Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial.,"OBJECTIVES


To evaluate through computer software analysis, the efficacy of the use of a plaque disclosing agent as a visual guide for biofilm removal during professional mechanical plaque removal in terms of post-treatment residual plaque area (RPA).
METHODS


Thirty-two healthy patients were selected and randomized in two groups to receive a session of professional mechanical plaque removal with air-polishing followed by ultrasonic instrumentation with (Guided Biofilm therapy-GBT) or without (Control) the preliminary application of a plaque disclosing agent as visual guide. The residual plaque area (RPA) was evaluated through re-application of the disclosing agent and computer software analysis, considering the overall tooth surface and the gingival and coronal portions separately.
RESULTS


A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) vs 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) vs 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (P-value = .018) on the former surface to more than 60% (P-value = .002) on the latter.
CONCLUSION


The application of a plaque disclosing agent to guide plaque removal seems to lead to better biofilm removal.",2020,"A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) versus 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) versus 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (p-value= 0.018) on the former surface to more than 60% (p-value = 0.002) on the latter.
",['32 healthy patients'],['professional mechanical plaque removal with air-polishing followed by ultrasonic instrumentation with (Guided Biofilm therapy - GBT) or without (Control) the preliminary application of a plaque disclosing agent as visual guide'],"['Gingival surface', 'Residual Plaque Area (RPA', 'GBT achieving an RPA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",32.0,0.025827,"A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) versus 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) versus 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (p-value= 0.018) on the former surface to more than 60% (p-value = 0.002) on the latter.
","[{'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Mensi', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Sordillo', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Agosti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.'}]",International journal of dental hygiene,['10.1111/idh.12442']
37,32354298,Effects of Peak Inspiratory Pressure-Guided Setting of Intracuff Pressure for Laryngeal Mask Airway Supreme™ Use during Laparoscopic Cholecystectomy: A Randomized Controlled Trial.,"Purpose:  To determine the effects of peak inspiratory pressure (PIP)-guided intracuff pressure (ICP) modulation of laryngeal mask airway (LMA) Supreme™ during laparoscopic cholecystectomy. Methods:  Totally 120 patients were randomly divided using computer-generated numbers into a control group (n = 60; ICP, 60 cmH 2 O) and a PIP group (n = 60), in which ICP was increased with 5 cmH 2 O each time from PIP level until no air leaks from the oropharynx. PIP, ICP, cuff volume (CV), oropharyngeal leak pressure (OLP) and leak fraction (LF) were recorded before and after pneumoperitoneum establishment. Postoperative pharyngolaryngeal complications (sore throat, dysphagia, pharyngeal hematoma, and dysphonia) were also recorded. Results:  Demographic data were similar in the two groups. The CV and ICP before and after pneumoperitoneum were significantly lower in the PIP group (CV: 15.6 ± 2.3 mL and 21.0 ± 2.6 mL; ICP: 14.3 ± 2.9 cmH 2 O and 20.5 ± 3.4 cmH 2 O) than in the control group (CV: 33.0 ± 2.8 mL and 32.8 ± 1.9 mL; ICP: 60.0 ± 0.1 cmH 2 O and 60.0 ± 0.1 cmH 2 O) ( P  < 0.05). Although OLP was lower in the PIP group ( P  < 0.05), the LF was similar in the two groups ( P  > 0.05). There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05). Conclusions:  Compared with a fixed ICP of 60 cmH 2 O, PIP-guided ICP modulation during LMA Supreme™ use provided effective airway sealing at a lower CV and ICP, and produced fewer postoperative pharyngolaryngeal complications in patients undergoing laparoscopic cholecystectomy.",2020,There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05).,"['Laparoscopic Cholecystectomy', 'Totally 120 patients', 'patients undergoing laparoscopic cholecystectomy']","['laparoscopic cholecystectomy', 'peak inspiratory pressure (PIP)-guided intracuff pressure (ICP) modulation of laryngeal mask airway (LMA', 'Peak Inspiratory Pressure-Guided Setting of Intracuff Pressure for Laryngeal Mask Airway Supreme']","['postoperative pharyngolaryngeal complications', 'CV and ICP', 'OLP', 'Postoperative pharyngolaryngeal complications (sore throat, dysphagia, pharyngeal hematoma, and dysphonia', 'LF', 'PIP, ICP, cuff volume (CV), oropharyngeal leak pressure (OLP) and leak fraction (LF']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C2242660', 'cui_str': 'Pharyngeal haematoma'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",120.0,0.046459,There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05).,"[{'ForeName': 'Mao-Hua', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Dong-Sheng', 'Initials': 'DS', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Shun-Ping', 'Initials': 'SP', 'LastName': 'Tian', 'Affiliation': 'School of Medicine, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Tian-Qi', 'Initials': 'TQ', 'LastName': 'Zhou', 'Affiliation': 'Preventive Health Care Office, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sui', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1761487']
38,32356115,Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis.,"In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA.",2020,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","['424 patients', 'psoriatic arthritis', 'patients with psoriatic arthritis (PsA']","['subcutaneous abatacept 125\xa0mg weekly or placebo', 'placebo']","['ACR20 response', 'elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and\u2009≥\u20093 joint erosions', 'Odds ratios (ORs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",424.0,0.122464,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA. pmease@philipmease.com.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'FitzGerald', 'Affiliation': ""St. Vincent's University Hospital, The Conway Institute for Biomolecular Research, and University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Excelya, Boulogne-Billancourt, France.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]",Rheumatology international,['10.1007/s00296-020-04564-x']
39,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE


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


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


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


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


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


ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794']
40,32345132,Resistance training attenuates circulating FGF-21 and myostatin and improves insulin resistance in elderly men with and without type 2 diabetes mellitus: A randomised controlled clinical trial.,"Fibroblast growth factor 21 (FGF-21) and myostatin have been proposed to be potential therapeutic target for insulin resistance in age-related metabolic disorders including type 2 diabetes (T2D). Moreover, despite the potential metabolic effect of resistance training on insulin resistance, aging, and T2D; the effect of this type of exercise training on FGF-21 and myostatin in elderly men with and without T2D are unknown. Forty-four elderly men were assigned to either the RT training (RT; without T2D: 12, with TD2 = 10) or the control group (C; without T2D: 12, with TD2 = 10). The RT group performed 12-wk resistance training intervention, 3 days/wk, 10 repetitions with 70% 1RM. At the baseline, the elderly men with T2D had a higher FGF-21 ( p  = 0.002) and myostatin ( p  = 0.02) concentrations and lower muscle strength ( p  = 0.01) than the elderly men without T2D. RT resulted in significant decrease in FGF-21 and myostatin concentration and increase in muscle strength in both elderly men with and without T2D ( P  = 0.001, for all) as well as decrease in HOMA-IR in only elderly men without T2D ( P  = 0.001). There was no significant difference in the RT-induced FGF-21 reduction between elderly men with and without T2D ( p  = 0.77,  p  = 0.28, respectively), but, RT caused a larger reduction in circulating myostatin in elderly men without T2D than with T2D ( P  = 0.007). Taken together, our results demonstrated that 12 weeks of RT induced an overall significant reduction of FGF-21 and myostatin in elderly men with and without T2D; with higher reduction of myostatin in elderly men without T2D.",2020,"There was no significant difference in the RT-induced FGF-21 reduction between elderly men with and without T2D (p=0.77, p=0.28, respectively), but, RT caused a larger reduction in circulating myostatin in elderly men without T2D than with T2D (P=0.007).","['elderly men with and without T2D are unknown', 'elderly men with and without T2D', 'elderly men with and without type 2 diabetes mellitus', 'Forty-four elderly men', 'elderly men without T2D']","['exercise training', 'Fibroblast growth factor 21 (FGF-21) and myostatin', 'Resistance training', 'resistance training', 'RT training']","['circulating myostatin', 'HOMA-IR', 'insulin resistance', 'myostatin (p=0.02) concentrations and lower muscle strength', 'FGF-21 and myostatin concentration', 'FGF-21 and myostatin', 'muscle strength', 'RT-induced FGF-21 reduction']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",44.0,0.0175279,"There was no significant difference in the RT-induced FGF-21 reduction between elderly men with and without T2D (p=0.77, p=0.28, respectively), but, RT caused a larger reduction in circulating myostatin in elderly men without T2D than with T2D (P=0.007).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shabkhiz', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Exercise Physiology, Tehran University, Tehran, Iran.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Khalafi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Guilan, Rasht, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, College of Health and Human Sciences, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Pouran', 'Initials': 'P', 'LastName': 'Karimi', 'Affiliation': 'Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamilia', 'Initials': 'K', 'LastName': 'Moghadami', 'Affiliation': 'Department of pure and basic science, Hashtgerd Branch, Islamic Azad University, Karaj, Iran.'}]",European journal of sport science,['10.1080/17461391.2020.1762755']
41,32352163,Comment on: Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).,,2020,,[],['intracorporeal versus extracorporeal anastomosis'],[],[],"[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]",[],,0.105983,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zizzo', 'Affiliation': 'Surgical Oncology Unit, Reggio Emilia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zanelli', 'Affiliation': 'Pathology Unit, Reggio Emilia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Soriano', 'Affiliation': 'Gastroenterology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Annessi', 'Affiliation': 'General Surgery Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Guastalla, Modena, Italy.'}]",The British journal of surgery,['10.1002/bjs.11614']
42,32350903,A randomized controlled trial of the effects of non-surgical periodontal therapy on cardiac function assessed by echocardiography in type 2 diabetic patients.,"BACKGROUND


Periodontitis significantly increases the risk of diabetic complications. This clinical trial investigated the effects of periodontal therapy on cardiac function in patients with type 2 diabetes mellitus (T2DM) and periodontitis.
MATERIALS AND METHODS


Fifty-eight subjects with T2DM and periodontitis were randomly allocated to Treatment Group (n = 29) receiving non-surgical periodontal therapy, and Control Group (n = 29) having only oral hygiene instructions with delayed periodontal treatment until completion of this 6-month study. The left ventricle (LV) diastolic function was assessed by echocardiography with the tissue Doppler imaging index (E/e' ratio); and LV hypertrophy was evaluated by LV mass index (LVMI). Blood samples were collected for biochemical analysis.
RESULTS


The intention-to-treat analysis showed that periodontal treatment significantly reduced the E/e' ratio by 1.66 (95% CI: -2.64 to -0.68, p < .01), along with marked improvement of periodontal conditions (p < .05). LVMI was not altered at the 6-month follow-up. The serum levels of N-terminal pro-B type natriuretic peptide (NT-proBNP) as a cardiac stress biomarker, C-reactive protein and interleukin-6 decreased numerically without reaching statistical significance.
CONCLUSION


The present study provides the first evidence that non-surgical periodontal therapy may improve cardiac diastolic function in type 2 diabetic patients with periodontitis.",2020,"The intention-to-treat analysis showed that periodontal treatment significantly reduced the E/e' ratio by 1.66 (95% CI: -2.64 to -0.68, p < .01), along with marked improvement of periodontal conditions (p < .05).","['patients with type 2 diabetes mellitus (T2DM) and periodontitis', 'Fifty-eight subjects with T2DM and periodontitis', 'type 2 diabetic patients with periodontitis', 'type 2 diabetic patients']","['periodontal therapy', 'non-surgical periodontal therapy', 'Treatment Group (n\xa0=\xa029) receiving non-surgical periodontal therapy, and Control Group (n\xa0=\xa029) having only oral hygiene instructions with delayed periodontal treatment']","['risk of diabetic complications', 'serum levels of N-terminal pro-B type natriuretic peptide (NT-proBNP', 'cardiac diastolic function', 'LVMI', ""E/e' ratio"", 'cardiac function', 'periodontal conditions', 'left ventricle (LV) diastolic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}]",58.0,0.0254811,"The intention-to-treat analysis showed that periodontal treatment significantly reduced the E/e' ratio by 1.66 (95% CI: -2.64 to -0.68, p < .01), along with marked improvement of periodontal conditions (p < .05).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Periodontology & Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hin Nam', 'Initials': 'HN', 'LastName': 'Liu', 'Affiliation': 'Division of Periodontology & Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pelekos', 'Affiliation': 'Division of Periodontology & Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Mei Zhen', 'Initials': 'MZ', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Tonetti', 'Affiliation': 'Division of Periodontology & Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hung Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': 'Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kai Hang', 'Initials': 'KH', 'LastName': 'Yiu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Division of Periodontology & Implant Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13291']
43,32353115,ACTH Infusion Impairs Baroreflex Sensitivity-Implications for Cardiovascular Hypoglycemia-Associated Autonomic Failure.,"CONTEXT


Hypoglycemia attenuates cardiovascular homeostatic autonomic control. This attenuation, known as the cardiovascular component of hypoglycemia-associated autonomic failure (HAAF), is characterized most notably by decreased baroreflex sensitivity (BRS) that begins during hypoglycemia and persists until at least the next day, despite return to euglycemia. Understanding the mechanisms underlying this reduction in BRS is important because BRS attenuation is associated with increased morbidity and mortality.
OBJECTIVE


The objective of this work is to investigate the role of the adrenocorticotropin (ACTH)-adrenal axis in decreasing BRS. We tested the hypothesis that infusion of ACTH 1-24 (cosyntropin), as compared to placebo, would acutely suppress BRS, and that this decrease in BRS would be present the next day.
DESIGN


A double-blind, placebo-controlled, random-order, cross-over study was conducted.
SETTING


This study took place in a clinical research center.
PARTICIPANTS


Participants included healthy men and women.
INTERVENTIONS


Interventions included an intravenous infusion of cosyntropin (70 μg/hour for 2.5 hours in the morning and again in the early afternoon) vs normal saline placebo.
MAIN OUTCOME MEASURES


Outcome measures included BRS during and 16 hours after cosyntropin vs placebo infusions.
RESULTS


Cosyntropin infusion attenuated BRS (mm Hg/ms) as compared to placebo (baseline 17.8 ± 1.38 vs 17.0 ± 2.07; during 14.4 ± 1.43 vs 17.3 ± 1.65; and next day 14.8 ± 1.42 vs 18.9 ± 2.04; P < .05, time by treatment, analysis of variance). BRS was decreased during the final 30 minutes of the morning cosyntropin infusion as compared to baseline (P < .01) and remained suppressed the next day (16 hours after afternoon infusion) (P < .025). Placebo infusion did not significantly change BRS. Corrected QT interval was not affected.
CONCLUSIONS


ACTH attenuates BRS, raising the possibility that hypoglycemia-induced increases in ACTH may contribute to the cardiovascular component of HAAF.",2020,"QTc was not affected.
",['Healthy men and women'],"['normal saline placebo', 'Placebo', 'ACTH Infusion', 'cosyntropin', 'adrenocorticotropin hormone (ACTH)-adrenal axis', 'placebo']","['change BRS', 'BRS', 'QTc', 'baroreflex sensitivity (BRS']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0199780', 'cui_str': 'Administration of hormone'}, {'cui': 'C0010192', 'cui_str': 'Cosyntropin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",,0.120712,"QTc was not affected.
","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Leung', 'Affiliation': 'Division of Endocrinology and Diabetes, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Bayomy', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bonyhay', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Celli', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa221']
44,32358375,Computed tomography (CT) imaging evaluation of integrated traditional Chinese medicine cooperative therapy in treating acute cerebral infarction: A randomized controlled trial.,"INTRODUCTION


Acute cerebral infarction is a clinically common cerebrovascular disease. Acute cerebral infarction is characterized by sudden onset, dangerous illness, high risk of death, and disability. Computed tomography perfusion imaging can detect abnormal brain tissue perfusion 30 minutes after the onset of cerebral ischemia, providing the earliest and most valuable information for clinical diagnosis and treatment. In recent years, the effect of traditional Chinese medicine on acute cerebral infarction has been remarkable.
METHODS/DESIGN


This study plan randomly divided eligible acute cerebral infarction patients into two groups. Patients in the control group will be treated with conventional Western medicine; patients in the intervention group will be treated with traditional Chinese medicine cooperative therapy on the basis of conventional Western medicine. The curative effects will be selected before treatment, 2 weeks after treatment, and 3 months follow-up. The changes in CT imaging evaluation, NIHSS score, and BI index of the two groups of patients will be observed.
DISCUSSION


We aim to provide higher evidence-based medical evidence for traditional Chinese medicine treatment of acute cerebral infarction. And clarify the application value of computed tomography perfusion imaging in the diagnosis and efficacy evaluation of acute cerebral infarction.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000030230, Registered on 03 March 2020.",2020,"The changes in CT imaging evaluation, NIHSS score, and BI index of the two groups of patients will be observed.
","['acute cerebral infarction', 'plan randomly divided eligible acute cerebral infarction patients into two groups']","['computed tomography perfusion imaging', 'Computed tomography perfusion imaging', 'conventional Western medicine', 'traditional Chinese medicine', 'traditional Chinese medicine cooperative therapy', 'Computed tomography (CT) imaging evaluation of integrated traditional Chinese medicine cooperative therapy']","['CT imaging evaluation, NIHSS score, and BI index']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.127749,"The changes in CT imaging evaluation, NIHSS score, and BI index of the two groups of patients will be observed.
","[{'ForeName': 'Ruijia', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Lianying', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}]",Medicine,['10.1097/MD.0000000000019998']
45,32358376,Study of efficacy and safety of Jiaotai pill in the treatment of depression.,"BACKGROUND


Depression is a common affective disorder characterized by marked and lasting melancholia, with corresponding thought and behavior changes. Due to an accelerated pace of life and increased work pressure, the incidence of depression has risen sharply, causing great harm to family and social life. Jiaotai pill (JTP) is a Chinese herbal formula that is commonly prescribed for depression and insomnia in clinical treatment, and exhibits antidepressant effects as shown in animal experimental research. However, there are no standard clinical trials to confirm its efficacy in treating depression.
OBJECTIVE


This study aims to assess the efficacy and safety of JTP in the treatment of depression, so as to tap the clinical efficacy advantages of JTP and provide data support for its clinical application.
METHODS


A randomized, multicenter clinical trial with parallel groups was designed in this study. A total of 40 patients with depression were included and randomly divided to either the treatment or the control group with a ratio of 1:1. The patients received JTP plus fluoxetine or fluoxetine alone once per day for 8 weeks. The primary outcome included the Hamilton Depression Rating Scale score for patients and brain structure and function by functional magnetic resonance imaging. The secondary outcomes included Traditional Chinese medicine syndrome integral scale scores, Wisconsin Card Sorting Test, blood metabonomics, urine metabonomics.
CONCLUSION


The results of this trial will find changes in brain structure, brain function, and metabolism in patients with depression, and provide critical evidence for JTP in the treatment of depression.",2020,A total of 40 patients with depression were included and randomly divided to either the treatment or the control group with a ratio of 1:1.,"['40 patients with depression', 'patients with depression']","['JTP', 'JTP plus fluoxetine or fluoxetine', 'Jiaotai pill', 'Jiaotai pill (JTP']","['efficacy and safety', 'Hamilton Depression Rating Scale score for patients and brain structure and function by functional magnetic resonance imaging', 'Traditional Chinese medicine syndrome integral scale scores, Wisconsin Card Sorting Test, blood metabonomics, urine metabonomics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3852419', 'cui_str': 'jiaotai'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1956136', 'cui_str': 'Metabonomics'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",40.0,0.108319,A total of 40 patients with depression were included and randomly divided to either the treatment or the control group with a ratio of 1:1.,"[{'ForeName': 'Zhihuan', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'College of Traditional Chinese Medicine.'}, {'ForeName': 'Shufei', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'College of Traditional Chinese Medicine.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Graduate School, Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychosomatic Disease, Tianjin Hospital of ITCWM Nankai Hospital.'}, {'ForeName': 'Huaien', 'Initials': 'H', 'LastName': 'Bu', 'Affiliation': 'College of Traditional Chinese Medicine.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'Department of Psychosomatic Disease, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Clinical Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Chunquan', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Editorial Department, Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}]",Medicine,['10.1097/MD.0000000000019999']
46,32353816,Effects of a Mindfulness-based Intervention on diurnal cortisol pattern in disadvantaged families: A randomized controlled trial.,"OBJECTIVE


The present study examined the psychophysiological effects of Family-based Mindfulness Intervention (FBMI) on children and parents from disadvantaged families.
METHODS


This randomized controlled trial recruited parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n = 26) and waitlist control (n = 25) groups. The parent intervention included 6 sessions and the child intervention included 8 sessions with 2 half-hour joint programs. Both interventions lasted 9 hours in total each. All participants completed four salivary cortisol measures after wakeup, before lunchtime, late-afternoon, and before sleep at baseline and end of the intervention. The diurnal cortisol pattern was summarized by the morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope.
RESULTS


Compared to the control group, children in the FBMI group showed significant increases in morning cortisol (d = 0.50, p =  0.03) and significant decreases in diurnal cortisol slopes (d = 0.50, p =  0.04) at the end of intervention. Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention. No significant treatment effects were found on the mean cortisol.
DISCUSSION


The present findings suggest that FBMI could improve the diurnal cortisol slope and cortisol levels of the children and parents from disadvantaged families, respectively. Future studies should elucidate its potential benefits on neuroendocrine functioning.",2020,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","['children and parents from disadvantaged families', 'parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n\u202f=\u202f26) and waitlist control (n\u202f=\u202f25) groups', 'disadvantaged families']","['Mindfulness-based Intervention', 'FBMI', 'Family-based Mindfulness Intervention (FBMI', 'child intervention included 8 sessions with 2 half-hour joint programs']","['morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope', 'diurnal cortisol slopes', 'morning cortisol', 'evening cortisol', 'diurnal cortisol slope and cortisol levels', 'salivary cortisol measures', 'mean cortisol', 'diurnal cortisol pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",51.0,0.0257721,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: herman.lo@polyu.edu.hk.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104696']
47,32353906,"The ""11 for Health in Denmark"" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT.","BACKGROUND


The present study investigates the well-being effects for 10- to 12-year-old children  who participated in the school-based intervention ""11 for Health in Denmark,"" which comprises physical activity (PA) and health education. Subgroup analyses were carried out for boys and girls.
METHOD


Three thousand sixty-one children were randomly assigned to an intervention group (IG) or a control group (CG) by 5:1 cluster randomization by school. 2533 children (mean age 11.5 ± 0.4; 49.7% boys) were assigned to IG and 528 children (mean age 11.4 ± 0.5; 50.8% boys) were assigned to CG. IG participated in the ""11 for Health in Denmark"" 11-week program, consisting of 2 × 45 min per week of football drills, small-sided games, and health education. CG did not participate in any intervention and continued with their regular education. Before and after the intervention period, both groups answered a shortened version of the multidimensional well-being questionnaire KIDSCREEN-27.
RESULTS


The ""11 for Health in Denmark"" intervention program had a positive effect on physical well-being in girls (IG: 48.6 ± 8.5 to 50.2 ± 9.3), whereas the improvement was not significant in boys. The program also had a positive impact on well-being scores for peers and social support (IG: 50.2 ± 10.2 to 50.8 ± 10.1), though when analyzed separately in the subgroups of boys and girls the changes were not significant. No between-group differences were found for psychological well-being or school environment.
CONCLUSION


The intervention program had a positive between-group effect on physical well-being in girls, whereas the change was not significant in boys. The overall scores for peers and social support improved during the intervention period, but no subgroup differences were found.",2020,"The programme also had positive impact on well-being score for peers and social support (IG: 50.2±10.2 to 50.8±10.1), but when analysed separately in the subgroups of boys and girls the changes were not significant.","['2533 children (mean age 11.5±0.4; 49.7% boys) were assigned to IG and 528 children (mean age 11.4±0.5; 50.8% boys', '10-12-year-old children of the school-based intervention ""11 for Health in Denmark"", which comprises physical activity (PA) and health education', 'children', '3061', '10-12-year-old Danish girls and boys']","['intervention group (IG) or a control group (CG', 'CG']","['psychological well-being or school environment', 'overall scores for peers and social support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",3061.0,0.0329689,"The programme also had positive impact on well-being score for peers and social support (IG: 50.2±10.2 to 50.8±10.1), but when analysed separately in the subgroups of boys and girls the changes were not significant.","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Elbe', 'Affiliation': 'Institute of Sport Psychology and Physical Education, Faculty of Sport Science, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Esben Elholm', 'Initials': 'EE', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Ermidis', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Ryom', 'Affiliation': 'Department of Public Health, Section of Health Promotion and Global Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Johan Michael', 'Initials': 'JM', 'LastName': 'Wikman', 'Affiliation': 'Centre for Research on Welfare, Health and Sport (CVHI), Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Rasmussen Lind', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Malte Nejst', 'Initials': 'MN', 'LastName': 'Larsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13704']
48,32356413,Twelve-hour fasting compared with expedited oral intake in the initial inpatient management of hyperemesis gravidarum: a randomised trial.,"OBJECTIVE


To evaluate fasting for 12 hours compared with expedited oral feeding in hospitalised women with hyperemesis gravidarum (HG).
DESIGN


Randomised trial.
SETTING


University Hospital, Malaysia: April 2016-April 2017.
POPULATION


One hundred and sixty women hospitalised for HG.
METHOD


Women were randomised upon admission to fasting for 12 hours or expedited oral feeding. Standard HG care was instituted.
MAIN OUTCOME MEASURE


Primary outcome was satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score at enrolment, and at 8, 16 and 24 hours.
RESULTS


Satisfaction score, median (interquartile range) 8 (5-9) versus 8 (7-9) (P = 0.08) and 24-hour vomiting episodes were 1 (0-4) versus 1 (0-5) (P = 0.24) for 12-hour fasting versus expedited feeding, respectively. Repeated measures analysis of variance of nausea scores over 24 hours showed no difference (P = 0.11) between trial arms. Participants randomised to 12-hour fasting compared with expedited feeding were less likely to prefer their feeding regimen in future hospitalisation (41% versus 65%, P = 0.001), to recommend to a friend (65% versus 84%, P = 0.01; RR 0.8, 95% CI 0.6-0.9) and to adhere to protocol (85% versus 95%, P = 0.04; RR 0.9, 95% CI 0.8-1.0). Symptoms profile, ketonuria status at 24 hours and length of hospital stay were not different.
CONCLUSION


Advisory of 12-hour fasting compared with immediate oral feeding resulted in a non-significant difference in satisfaction score but adherence to protocol and fidelity to and recommendation of immediate oral feeding to a friend were lower. The 24-hour nausea scores and vomiting episodes were similar.
TWEETABLE ABSTRACT


Women hospitalised for hyperemesis gravidarum could feed as soon, as much and as often as can be tolerated compared with initial fasting.",2020,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","['hospitalised hyperemesis gravidarum (HG) DESIGN', '160 women hospitalised for hyperemesis gravidarum (HG) METHOD', 'University Hospital, Malaysia: April 2016-April']",[],"['24-hour vomiting episodes', 'nausea scores', 'satisfaction score', '24-hour nausea scores and vomiting episodes', 'satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score', 'Symptoms profile, ketonuria status at 24 hours and length of hospital stay']","[{'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.218001,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Abdussyukur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16290']
49,32359104,Long-term safety and efficacy of nalmefene in Japanese patients with alcohol dependence.,"AIM


The safety and efficacy of nalmefene in Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence were assessed in a multicenter, randomized, double-blind, placebo-controlled, phase 3 (lead-in) study. Here, the long-term safety and efficacy of nalmefene in an open-label extension of the lead-in study are presented.
METHODS


Patients who completed the 24-week lead-in study were eligible for the extension study, where they were treated with nalmefene 20 mg as needed for 24 weeks. The long-term safety and efficacy of nalmefene 20 mg during the total 48-week period were evaluated. Treatment-emergent adverse events during the study period were recorded and change from baseline in the number of heavy drinking days and total alcohol consumption were calculated.
RESULTS


Overall, long-term nalmefene 20 mg was well tolerated; the main treatment-emergent adverse events reported in ≥5% of patients included nasopharyngitis (37.2%), nausea (36.5%), somnolence (21.2%), dizziness (16.8%), malaise (14.6%), and vomiting (12.4%). The number of heavy drinking days and total alcohol consumption decreased from baseline to 48 weeks (mixed model for repeated measures, least squares mean ± standard error, -15.09 ± 0.77 days/month and -53.20 ± 2.29 g/day, respectively) during the study.
CONCLUSION


This long-term evaluation in Japanese patients with high or very high drinking risk levels of alcohol dependence indicated that nalmefene was safe, well tolerated, and efficacious.",2020,"The number of heavy drinking days and total alcohol consumption decreased from baseline to 48 weeks (mixed model for repeated measures, least squares mean ± standard error, -15.09 ± 0.77 days/month and -53.20 ± 2.29 g/day, respectively) during the study.
","['Japanese patients with alcohol dependence', 'Patients who completed the 24-week lead-in study were eligible for the extension study, where they were treated with nalmefene 20 mg as needed for 24\u2009weeks', 'Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence', 'Japanese patients with a high or very high drinking risk levels of alcohol dependence']","['nalmefene', 'placebo']","['dizziness', 'tolerated', 'number of heavy drinking days and total alcohol consumption', 'malaise', 'vomiting', 'safety and efficacy', 'somnolence', 'nasopharyngitis', 'nausea']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.235028,"The number of heavy drinking days and total alcohol consumption decreased from baseline to 48 weeks (mixed model for repeated measures, least squares mean ± standard error, -15.09 ± 0.77 days/month and -53.20 ± 2.29 g/day, respectively) during the study.
","[{'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Higuchi', 'Affiliation': 'National Hospital Organization, Kurihama Medical and Addiction Center, Yokosuka, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Clinical Management, Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Murai', 'Affiliation': 'Department of Clinical Management, Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Tsuneyoshi', 'Affiliation': 'Department of Biometrics, Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Nakamura', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Meulien', 'Affiliation': 'Clinical Research and Development, H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Hisatsugu', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Tokyo, Japan.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13017']
50,32359506,"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND


The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation.
METHODS


In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m 2  administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m 2  administered orally on days 1-4) and prednisone (60 mg/m 2  administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m 2 ), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m 2  either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment.
FINDINGS


Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]).
INTERPRETATION


This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone.
FUNDING


Janssen and Celgene.",2020,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"['untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network', 'Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein', 'patients with newly diagnosed multiple myeloma', '1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428', '1503 patients were enrolled', 'patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus', 'All patients who received at least one dose of study drugs were included in the safety analyses', 'Between Feb 25, 2011, and April 3, 2014', 'newly diagnosed multiple myeloma (EMN02/HO95']","['VMP or single or double HSCT', 'prednisone', 'autologous HSCT after high-dose melphalan', 'lenalidomide', 'dexamethasone', 'bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy', 'melphalan', 'consolidation therapy with bortezomib', 'lenalidomide maintenance therapy', 'autologous HSCT', 'VMP', 'bortezomib', 'L or urine M protein', 'Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy', 'autologous haematopoietic stem-cell transplantation (HSCT', 'autologous HSCT with bortezomib-melphalan-prednisone (VMP']","['median progression-free survival', 'neutropenia', 'progression-free survival', 'number of events of progression or death at data cutoff', 'gastrointestinal disorders', 'cardiac events', 'serious adverse event', 'thrombocytopenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",1503.0,0.203417,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Vincent H J', 'Initials': 'VHJ', 'LastName': 'van der Velden', 'Affiliation': 'Department of Immunology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate ""GF Ingrassia"", Università degli Studi di Catania, Catania, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': '4th Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamberi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Alexsandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Iolanda D', 'Initials': 'ID', 'LastName': 'Vincelli', 'Affiliation': 'Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Hematology, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Niels Frost', 'Initials': 'NF', 'LastName': 'Andersen', 'Affiliation': 'Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pascarella', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Morelli', 'Affiliation': 'Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, ""Spirito Santo"" Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'von dem Borne', 'Affiliation': 'Department of Hematology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Caravita di Toritto', 'Affiliation': 'UOSD Ematologia ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Hematology, University Aldo Moro, Bari, Italy.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Kliniek, Zwolle, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mandigers', 'Affiliation': 'Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': 'Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Palmas', 'Affiliation': 'Haematology, Ospedale San Francesco, Nuoro, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30099-5']
51,32356211,Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial.,"OBJECTIVES


The aim of this study was to compare the antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries (S-ECC).
MATERIALS AND METHODS


The study was conducted in 92 children with S-ECC. Patients who completed dental treatment under general anaesthesia were included in the study. Patients were divided randomly into four groups: 5% sodium fluoride (SF) control group (n = 23), 5% SF with tricalcium phosphate (TCP) (n = 23), 5% SF with xylitol-coated calcium and phosphate (CXP) (n = 23) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (n = 23). Saliva mutans streptococci (MS) and lactobacilli (LB) levels were evaluated by taking saliva samples at baseline (T 0 ), 1 month (T 1 ) and 3 months (T 2 ) after treatment.
RESULTS


All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group. Only the TCP group exhibited significantly decrease MS and LB levels indicating less than 10 5  CFU at both T 1  and T 2  compared with the other groups (P < 0.05).
CONCLUSION


Fluoride varnish with TCP provided significantly more reduction in MS and LB levels than other fluoride varnishes.
CLINICAL RELEVANCE


Fluoride varnish with TCP had a significant antibacterial effect against cariogenic bacteria until the end of the third month. Long lasting antibacterial effect provides additional advantage for reducing bacteria levels in children.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03625310.",2020,All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group.,"['children with severe early childhood caries', 'children', 'children with severe early childhood caries (S-ECC', 'Patients who completed dental treatment under general anaesthesia were included in the study', '92 children with S-ECC']","['fluoride varnishes', 'sodium fluoride (SF) control group (n\xa0=\u200923), 5% SF with tricalcium phosphate (TCP) (n\xa0=\u200923), 5% SF with xylitol-coated calcium and phosphate (CXP) (n\xa0=\u200923) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'TCP', 'Fluoride varnish with TCP']","['MS and LB levels', 'antibacterial activity', 'Antibacterial activity', 'bacteria levels', 'Saliva mutans streptococci (MS) and lactobacilli (LB) levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",92.0,0.0392861,All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group.,"[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkmen Almaz', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey. dt.merveerkmen@gmail.com.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Akbay Oba', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03300-w']
52,32358379,Efficacy assessment of acupuncture in improving symptoms of uterine fibroids: A randomized controlled trial.,"INTRODUCTION


Uterine fibroids are a common benign genital tumor disease in gynecological diseases. It is mainly a change in physical function caused by the growth of smooth muscle cells in the factor uterus. Modern medicine's treatment of this disease is based on the dependence of uterine fibroids on sex hormones. Treatment with antiprogestin and estrogen drugs can reduce the volume of fibroids or slow the rate of increase in volume, thereby achieving the goal of alleviating clinical symptoms. In order to meet the needs of the majority of women of childbearing age and to maintain fertility, acupuncture treatment of uterine fibroids has a broad prospect for development.
METHODS/DESIGN


This study plans to select 60 cases that meet the corresponding selection criteria. According to the random principle, they will be divided into intervention group and control group, with 30 cases in each group. The general information, fibroid size, and TCM syndrome scores of the two groups of patients will be compared before treatment. In terms of treatment, the intervention group will be given acupuncture combined therapy; the control group will be given Chinese patent medicine. The treatment cycles in both groups will be three menstrual cycles. After the treatment is completed, the data of the relevant curative effect indicators are analyzed by using SPSS software to draw conclusions.
DISCUSSION


We aim to provide higher evidence-based medical evidence for acupuncture treatment of uterine fibroids.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000030438, Registered on March 01, 2020.",2020,"The general information, fibroid size, and TCM syndrome scores of the two groups of patients will be compared before treatment.",['uterine fibroids'],"['acupuncture', 'antiprogestin and estrogen drugs', 'acupuncture combined therapy']","['general information, fibroid size, and TCM syndrome scores', 'volume of fibroids']","[{'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.101735,"The general information, fibroid size, and TCM syndrome scores of the two groups of patients will be compared before treatment.","[{'ForeName': 'Min-Qin', 'Initials': 'MQ', 'LastName': 'Zheng', 'Affiliation': 'Fuzhou Hospital of Traditional Chinese Medicine, Fuzhou 350013.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Weng', 'Affiliation': 'Fujian University of Traditional Chinese Medicine, Fuzhou 350100.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ""The Second Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350013.""}, {'ForeName': 'Chong-Qing', 'Initials': 'CQ', 'LastName': 'Shen', 'Affiliation': ""The Second Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350013.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Dermatology, Huabei Petroleum General Hospital, Renqiu 062550.'}, {'ForeName': 'Zheng-Wei', 'Initials': 'ZW', 'LastName': 'Pan', 'Affiliation': 'Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital, Fuzhou 350013, China.'}]",Medicine,['10.1097/MD.0000000000020016']
53,32358381,Surgical or nonsurgical treatment for nontraumatic rotator cuff tears: Study protocol clinical trial.,"BACKGROUND


The optimal treatment for symptomatic, nontraumatic rotator cuff tear is unknown. The primary aim of this randomized controlled trial is to compare functional improvement after surgical and conservative treatment of nontraumatic rotator cuff tears.
METHODS


This is a single-centre, randomized clinical trial with a follow-up of 12 months. Patients older than 18 years with magnetic resonance imaging - confirmed nontraumatic rotator cuff tears that are suitable for either surgery or nonsurgery treatment is enrolled. The primary outcome is Constant score. Secondary outcome measures include visual analog scale (VAS) score, patient satisfaction, and American Shoulder and Elbow Surgeons (ASES) score. All scores are assessed by an independent observer who is blinded to the allocation of groups.
RESULTS


The study will provide much needed data on surgical vs nonsurgical treatment for nontraumatic rotator cuff tears. Results of this study may help patients, clinicians, and policy makers assess the pivotal question on comparative effectiveness of surgery vs nonsurgical for rotator cuff tears.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5442).",2020,Patients older than 18 years with magnetic resonance imaging - confirmed nontraumatic rotator cuff tears that are suitable for either surgery or nonsurgery treatment is enrolled.,"['nontraumatic rotator cuff tears', 'Patients older than 18 years with magnetic resonance imaging - confirmed nontraumatic rotator cuff tears']",['Surgical or nonsurgical treatment'],"['Constant score', 'visual analog scale (VAS) score, patient satisfaction, and American Shoulder and Elbow Surgeons (ASES) score']","[{'cui': 'C1828213', 'cui_str': 'Nontraumatic rotator cuff tear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]",,0.166818,Patients older than 18 years with magnetic resonance imaging - confirmed nontraumatic rotator cuff tears that are suitable for either surgery or nonsurgery treatment is enrolled.,"[{'ForeName': 'Ding-Gen', 'Initials': 'DG', 'LastName': 'Huang', 'Affiliation': 'Traumatic Orthopedics, Longhua District Central Hospital, Shenzhen City, Guangdong Province, 518110, China.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Cui-Lan', 'Initials': 'CL', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Ze-Jin', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Jin-Qi', 'Initials': 'JQ', 'LastName': 'Song', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020027']
54,32358383,Traditional Chinese medicine may reduce the dosage of systemic glucocorticoids in required patients with acute exacerbation of chronic obstructive pulmonary disease: Study protocol for a randomized placebo-controlled trial.,"INTRODUCTION


Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) involves a severe inflammatory response. Systemic glucocorticoids are very important for the treatment of the acute exacerbation period; however, their use causes serious adverse effects. There is still no evidence on whether traditional Chinese medicine (TCM) can be used to reduce the dosage of systemic glucocorticoids in the treatment of patients with AECOPD.
METHODS


In this trial, we plan to enroll 204 eligible patients with AECOPD who will be randomly assigned to receive TCM or a placebo. The effect of TCM in the treatment of patients with AECOPD will be measured by the dosage of systemic glucocorticoids (at which COPD assessment test [CAT] scores improve by 50%). Safety will also be assessed.
TRIAL REGISTRATION


ChiCTR2000029568.",2020,"There is still no evidence on whether traditional Chinese medicine (TCM) can be used to reduce the dosage of systemic glucocorticoids in the treatment of patients with AECOPD.
","['204 eligible patients with AECOPD', 'patients with AECOPD', 'patients with acute exacerbation of chronic obstructive pulmonary disease']","['TCM', 'Traditional Chinese medicine', 'traditional Chinese medicine (TCM', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],204.0,0.659746,"There is still no evidence on whether traditional Chinese medicine (TCM) can be used to reduce the dosage of systemic glucocorticoids in the treatment of patients with AECOPD.
","[{'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Wenfan', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Zengtao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Kunlan', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000020035']
55,32358397,Application of probiotics in adjuvant treatment of infant allergic rhinitis: A randomized controlled study.,"BACKGROUND


Several studies have suggested that intestinal flora may play an important role in allergic diseases. The purpose of this study was to investigate the effect of probiotics of Bifidobacterium triplex on the symptoms of allergic rhinitis (AR). The effects of this probiotic on the immune system have been reported in some studies, but most previous studies have been in animals.
METHODS/DESIGN


60 infants and young children with AR were randomly divided into 2 groups: probiotics/placebo group. The main outcome was the use of a comprehensive symptom drug score to assess allergy symptoms. In addition, health-related quality of life was investigated (rhinitis quality of life questionnaire). Secondary outcomes included a visual analog scale of allergy burden and a second quality of life questionnaire. This report describes the study design of a randomized controlled trial.
DISCUSSION


The study design described a double-center, randomized, location at the Minda Hospital of Hubei Minzu University and West China Hospital of Sichuan University, which will be focused on the study about probiotics treatment and its effect on AR symptoms.
TRIAL REGISTRATION


It has been registered at http://www.chictr.org.cn/listbycreater.aspx (Identifier: ChiCTR2000031175), Registered March 22, 2020.",2020,The main outcome was the use of a comprehensive symptom drug score to assess allergy symptoms.,"['infant allergic rhinitis', '60 infants and young children with AR', 'Minda Hospital of Hubei Minzu University and West China Hospital of Sichuan University']","['probiotics', 'probiotics/placebo', 'Bifidobacterium triplex']","['comprehensive symptom drug score to assess allergy symptoms', 'visual analog scale of allergy burden and a second quality of life questionnaire', 'health-related quality of life was investigated (rhinitis quality of life questionnaire', 'symptoms of allergic rhinitis (AR']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]",60.0,0.138695,The main outcome was the use of a comprehensive symptom drug score to assess allergy symptoms.,"[{'ForeName': 'Xueqiu', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhong', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.'}]",Medicine,['10.1097/MD.0000000000020095']
56,32358398,Eye-acupuncture with rehabilitation therapy for stroke.,"BACKGROUND


Stroke survivors are accompanied by dysfunctions, greatly declining their activities of daily living and bringing burden to families and societies. Although modern rehabilitation therapy has a systematic program in post-stroke motor rehabilitation, numbers of patients still recover slowly. Eye-acupuncture (EA), as an important type of acupuncture, has been widely applied effectively in rehabilitation of stroke for about 50 years. So we combine EA with modern rehabilitation which has achieved successful results. Therefore, we need to adopt an objective and accurate evaluation method to study the effect of this method.
METHODS


We aim to design a multi-center, block randomized, parallel control trial to assess the effect of eye-acupuncture combined with rehabilitation training therapy for patients with hemiplegia in the convalescent stage of stroke. 360 patients will be enrolled from 6 centres, with half of them (n = 180) in the control group (routine treatment group) and others (n = 180) in the experimental group (eye-acupuncture combined with routine treatment group). Stratified block randomization will be used in the study and the serial number 001-360 which corresponds to a participant will be assigned to each center randomly. We will use the sequentially sealed envelopes to hide the generating of assignment sequence. The cases of dropouts will be recorded with reasons. And the clinical CRFs will be filled in accurately, completely, and timely for statistical analysis.
RESULTS


To verify the clinical effects, we will measure the change of bellows from visit 1 to visit 4. Primary outcomes: activity of daily living (ADL) scales (modified Barthel index); simple Fugl-Meyer motor function score; functional magnetic resonance imaging (fMRI) of the brain in the resting state.
SECONDARY OUTCOMES


traditional Chinese medicine (TCM) syndrome score scale; western aphasia battery (WAB); water swallow test; Montreal cognitive assessment (MoCA); growth-associated protein-43 (GAP-43); microtubule-associated protein-2 (MAP-2).
CONCLUSION


The results of this study will provide present evidence on assessing effectiveness of EA combined with rehabilitation training for patients with hemiplegia in the convalescent stage of stroke.
TRIAL REGISTRATION


This trial has been registrated in Chinese Clinical Trail Registry with the registration number as ChiCTR1900027835 (http://www.chictr.org.cn/).",2020,"Primary outcomes: activity of daily living (ADL) scales (modified Barthel index); simple Fugl-Meyer motor function score; functional magnetic resonance imaging (fMRI) of the brain in the resting state.
","['360 patients will be enrolled from 6 centres, with half of them (n\u200a=\u200a180) in the control group (routine treatment group) and others (n\u200a=\u200a180) in the experimental group (eye', 'patients with hemiplegia in the convalescent stage of stroke']","['acupuncture combined with routine treatment', 'eye-acupuncture combined with rehabilitation training therapy', 'Eye-acupuncture with rehabilitation therapy', 'Eye-acupuncture (EA', 'modern rehabilitation therapy', 'EA combined with rehabilitation training']","['activity of daily living (ADL) scales (modified Barthel index); simple Fugl-Meyer motor function score; functional magnetic resonance imaging (fMRI) of the brain in the resting state', 'medicine (TCM) syndrome score scale; western aphasia battery (WAB); water swallow test; Montreal cognitive assessment (MoCA); growth-associated protein-43 (GAP-43); microtubule-associated protein-2 (MAP-2']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0451580', 'cui_str': 'Western aphasia battery'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0068563', 'cui_str': 'Growth-Associated Protein 43'}, {'cui': 'C0024773', 'cui_str': 'MAP2 Microtubule-Associated Protein'}]",360.0,0.182302,"Primary outcomes: activity of daily living (ADL) scales (modified Barthel index); simple Fugl-Meyer motor function score; functional magnetic resonance imaging (fMRI) of the brain in the resting state.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029.'}, {'ForeName': 'Pengqin', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110032.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110032.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Fuxin City Traditional Chinese Hospital, Fuxin 123000.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shengjing Hospital Affiliated to China Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Zhongshan Hospital Affiliated to Dalian University, China.'}]",Medicine,['10.1097/MD.0000000000020096']
57,32361265,Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma.,"BACKGROUND


Necuparanib, a rationally engineered low-molecular-weight heparin, combined with gemcitabine/nab-paclitaxel showed an encouraging safety and oncologic signal in a phase Ib trial. This randomised multicentre phase II trial evaluates the addition of necuparanib or placebo to gemcitabine/nab-paclitaxel in untreated metastatic pancreatic ductal adenocarcinoma (PDAC).
PATIENTS AND METHODS


Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1. Patients were randomly assigned to necuparanib (5 mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel on days 1, 8 and 15 of 28-day cycles. The primary end-point was median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety.
RESULTS


One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to placebo arm. The futility boundary was crossed at a planned interim analysis, and the study was terminated by the Data Safety Monitoring Board. The median OS was 10.71 months (95% confidence interval [CI]: 7.95-11.96) for necuparanib arm and 9.99 months (95% CI: 7.85-12.85) for placebo arm (hazard ratio: 1.12, 95% CI: 0.66-1.89, P-value: 0.671). The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
CONCLUSION


The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. Safety was acceptable. No further development of necuparanib is planned although targeting the coagulation cascade pathway remains relevant in PDAC. NCT01621243.",2020,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","['One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to', 'untreated metastatic pancreatic ductal adenocarcinoma (PDAC', 'Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1', 'untreated metastatic pancreas ductal adenocarcinoma']","['gemcitabine/nab-paclitaxel', 'gemcitabine and nab-paclitaxel with necuparanib or placebo', 'necuparanib (5\xa0mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel', 'necuparanib or placebo to gemcitabine/nab-paclitaxel', 'placebo']","['median OS', 'haematologic toxicity', 'median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety', 'safety and oncologic signal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",110.0,0.686627,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: oreillye@mskcc.org.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Devalingam', 'Initials': 'D', 'LastName': 'Mahalingam', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Scottsdale, AZ, USA; ACCRU Research Consortium, Rochester, MN, USA.'}, {'ForeName': 'Spencer H', 'Initials': 'SH', 'LastName': 'Shao', 'Affiliation': 'Compass Oncology, Rose Quarter Cancer Center, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Rosano', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology, US Oncology Research, 910 East Houston Street, Tyler, TX 71702, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roach', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ryan', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.005']
58,32363634,iGlarLixi effectively reduces residual hyperglycaemia in patients with type 2 diabetes on basal insulin: A post hoc analysis from the LixiLan-L study.,"Globally, nearly half of patients with type 2 diabetes (T2D) do not successfully achieve target HbA1c with basal insulin, despite meeting fasting plasma glucose (FPG) targets. In this post hoc analysis of the LixiLan-L study, we determined whether iGlarLixi, a fixed-ratio combination of insulin glargine Gla-100 (iGlar) and the glucagon-like peptide-1 receptor agonist lixisenatide (Lixi), addresses the challenge of reducing residual hyperglycaemia in patients with T2D. In LixiLan-L, a randomized, open-label study, 1018 patients with T2D on basal insulin for ≥6 months ± oral antidiabetes drugs entered a 6-week run-in period, during which they were switched to and/or optimized for a daily dose of iGlar while continuing only metformin. Following the run-in period, 736 patients were then randomized to receive iGlarLixi or were continued on iGlar for 30 weeks ± metformin. Residual hyperglycaemia was defined as HbA1c ≥ 7.0% despite FPG of <140 mg/dL. The proportion of patients with residual hyperglycaemia was similar in both treatment arms at screening (~~42%), and increased after the run-in period (~~62%). After 30 weeks, the proportion of patients with residual hyperglycaemia declined to 23.8% in the iGlarLixi versus 47.1% in the iGlar arm (P < .0001). The proportion of patients achieving both HbA1c (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively; P < .0001). iGlarLixi effectively reduces residual hyperglycaemia in patients with T2D on basal insulin therapy.",2020,"The proportion of patients achieving both HbA 1c  (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively, p < 0.0001).
","['736 patients', '140', 'patients with T2DM on basal insulin therapy', 'patients with T2DM', 'patients with type 2 diabetes on basal insulin', '1018 patients with T2DM on basal insulin for ≥6 months ± oral antidiabetes drugs entered a 6-week run-in period']","['FPG', 'metformin', 'iGlar while continuing only metformin', 'iGlarLixi', 'iGlarLixi, a fixed-ratio combination of insulin glargine Gla-100 (iGlar) and the glucagon-like peptide-1 receptor agonist lixisenatide (Lixi']","['FPG', 'residual hyperglycemia', 'proportion of patients with residual hyperglycemia', 'Residual hyperglycemia', 'proportion of patients achieving both HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",1018.0,0.0372836,"The proportion of patients achieving both HbA 1c  (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively, p < 0.0001).
","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morea', 'Affiliation': 'University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Retnakaran', 'Affiliation': 'Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BDM Consulting, Somerset, New Jersey, USA.'}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'University of Bari Aldo Moro, Bari, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14077']
59,32353714,Music during image-guided breast biopsy reduces patient anxiety levels.,"PURPOSE


Interventions to decrease anxiety associated with image-guided breast biopsy are needed. Music intervention has been shown to be helpful in other outpatient procedural settings but data are limited regarding its effectiveness in the setting of breast biopsy. The purpose of this study was to determine whether listening to self-selected music during image-guided breast biopsy lowers anxiety.
MATERIALS AND METHODS


This randomized controlled trial was approved by the institutional review board and was HIPAA-compliant. 157 women between 18 and 75 (mean, 49.7 years) years of age, undergoing stereotactic or ultrasound-guided core biopsy, were enrolled in the study and were prospectively randomized to music or usual care. Patients in the music group listened to music of their choice during the biopsy. All patients completed the State Trait Anxiety Inventory (STAI) before and after the biopsy. Differences in pre-biopsy and post-biopsy anxiety levels were compared between the two groups using the Mann-Whitney U test.
RESULTS


Baseline trait anxiety scores in the two groups were similar (34.0 music, 31.5 control, p = .11). Patients in both groups showed lower state anxiety levels after the biopsy (45.6 to 34.3 music, 41.0 to 33.8 control, p < .001 for both). Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03). Post-biopsy anxiety levels were similar to normative values for working women in the same age group.
CONCLUSION


Listening to self-selected music reduces anxiety in patients undergoing breast biopsy.",2020,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","['patients undergoing breast biopsy', '157 women between 18 and 75 (mean, 49.7\xa0years) years of age, undergoing stereotactic or ultrasound-guided core biopsy']","['Music intervention', 'music or usual care', 'Listening to self-selected music', 'music group listened to music of their choice during the biopsy', 'Music during image-guided breast biopsy', 'listening to self-selected music during image-guided breast biopsy']","['anxiety', 'pre-biopsy and post-biopsy anxiety levels', 'state anxiety levels', 'Post-biopsy anxiety levels', 'Baseline trait anxiety scores', 'State Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",157.0,0.0640536,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","[{'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Bennett', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America. Electronic address: Debbie.bennett@health.slu.edu.'}, {'ForeName': 'J Shannon', 'Initials': 'JS', 'LastName': 'Swan', 'Affiliation': 'MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Gazelle', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America; MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saksena', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.018']
60,32353739,Real time SVD-based clutter filtering using randomized singular value decomposition and spatial downsampling for micro-vessel imaging on a Verasonics ultrasound system.,"Singular value decomposition (SVD)-based clutter filters can robustly reject the tissue clutter as compared with the conventional high pass filter-based clutter filters. However, the computational burden of SVD makes real time SVD-based clutter filtering challenging (e.g. frame rate at least 10-15 Hz with region of interest of about 4 × 4 cm 2 ). Recently, we proposed an acceleration method based on randomized SVD (rSVD) clutter filtering and randomized spatial downsampling, which can significantly reduce the computational complexity without compromising the clutter rejection capability. However, this method has not been implemented on an ultrasound scanner and tested for its performance. In this study, we implement this acceleration method on a Verasonics scanner using a multi-core CPU architecture, and evaluate the selections of the imaging and processing parameters to enable real time micro-vessel imaging. The Blood-to-Clutter Ratio (BCR) performance was evaluated on a Verasonics machine with different settings of parameters such as block size and ensemble size. The demonstration of real time process was implemented on a 12-core CPU (downsampling factor of 12, 12-threads in this study) host computer. The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively. We also demonstrate that the micro-vessel imaging frame rate of the proposed architecture can reach approximately 22 Hz when the block size, ensemble size and the rank of tissue clutter subspace were set as 20 × 20 pixels, 45 and 26 respectively (using both images and supplementary videos). The proposed method may be important for real time 2D scanning of tumor microvessels in 3D to select and store the most representative 2D view with most abnormal micro-vessels for better diagnosis.",2020,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.",[],[],"['Blood-to-Clutter Ratio (BCR) performance', 'processing time of the rSVD-based clutter filter']",[],[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039010', 'cui_str': 'Swine Vesicular Disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]",,0.0321407,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.","[{'ForeName': 'U-Wai', 'Initials': 'UW', 'LastName': 'Lok', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Trzasko', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Daigle', 'Affiliation': 'Verasonics Inc., Kirkland, WA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Borisch', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Ultrasound, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Shigao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA. Electronic address: Chen.Shigao@mayo.edu.'}]",Ultrasonics,['10.1016/j.ultras.2020.106163']
61,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION


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


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


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


A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
62,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
63,32361667,Manipulating visual perspective for obsessional imagery and its impact on obsessive-compulsive symptoms in an analogue sample.,"Visual perspective may have an important role in the phenomenology of intrusive images relevant to psychological disorders such as obsessive-compulsive disorder (OCD). The aim of the current study was to examine the subjective and behavioural effects of manipulating visual perspective, to either field or observer, on intrusive images related to doubting and contamination concerns. One hundred and twelve undergraduate participants with high levels OCD symptoms were asked to identify and imagine an intrusive image related to either doubting or contamination concerns. We then randomly assigned them to re-visualise their image from either a field (first-person) or observer (third-person) visual perspective. Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective. In addition, those in the observer perspective evidenced a greater decrease on behavioural indices relevant to OCD, such as reduced frequency of the intrusive image and decreased efforts to neutralise the image. We discuss implications for imagery in OCD.",2020,"Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective.",['One hundred and twelve undergraduate participants with high levels OCD symptoms'],[],"['obsessive-compulsive symptoms', 'ratings of subjective measures of image-related distress']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",112.0,0.0318503,"Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective.","[{'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Derek A P', 'Initials': 'DAP', 'LastName': 'Hu', 'Affiliation': 'School of Psychology, UNSW Sydney, Kensington, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, UNSW Sydney, Kensington, Australia. Electronic address: jessicag@unsw.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102227']
64,32361668,Social comparison modulates coping with fear in virtual environments.,"Social comparison can guide adaptive behavior in fear-related situations. The aim of this study was to investigate the effects of social comparison standards on acute anxiety levels and phobic symptoms. The sample comprised 159 individuals (M age  = 23.4) with self-reported fear of flying (22.6 %) or fear of heights (77.4 %) who were randomly assigned to an upward assimilation (UA) manipulation, a downward assimilation (DA) manipulation, or a control condition (no manipulation of social comparison) and entered a fear-related scenario in virtual reality (i.e., flying in an airplane or walking in a tall building, respectively). Results revealed that individuals in the UA condition reported significantly attenuated increases in anxiety levels from pre-exposure to both during- and post-exposure relative to the control condition. The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure. At post-assessment, participants in the UA condition also reported fewer phobic symptoms compared to both the DA and the control condition. Our results suggest that social comparison can indeed modulate coping with fearful situations. Future research needs to investigate the underlying processes of social comparison and the extent to which social comparison can facilitate treatment of anxiety disorders.",2020,The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure.,['159 individuals (M age  = 23.4) with self-reported fear of flying (22.6 %) or fear of heights (77.4 %) who were randomly assigned to an'],"['social comparison standards', 'upward assimilation (UA) manipulation, a downward assimilation (DA) manipulation, or a control condition (no manipulation of social comparison) and entered a fear-related scenario in virtual reality (i.e., flying in an airplane or walking in a tall building, respectively']","['anxiety levels', 'phobic symptoms', 'acute anxiety levels', 'acute anxiety levels and phobic symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424184', 'cui_str': 'Fear of flying'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C1704301', 'cui_str': 'Assimilation, Cultural'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0683901', 'cui_str': 'Airplanes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0117484,The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure.,"[{'ForeName': 'Isabel L', 'Initials': 'IL', 'LastName': 'Kampmann', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: i.kampmann@uni-muenster.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: t.meyer@uni-muenster.de.'}, {'ForeName': 'Nexhmedin', 'Initials': 'N', 'LastName': 'Morina', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: morina@uni-muenster.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102226']
65,32359018,Efficacy of microneedling versus fractional Er:YAG laser in facial rejuvenation.,"BACKGROUND


Microneedling and fractional lasers have been used in facial rejuvenation with acceptable results and low adverse effects.
AIMS


To compare the efficacy of microneedling with fractional Er:YAG in facial skin rejuvenation.
PATIENTS/METHODS


This study was planned as a split-face clinical trial. Volunteers were randomly allocated to receive three monthly treatments on each side of the face, one with fractional Er:YAG laser and one with microneedling. The assessments included investigating clinical outcomes by two blinded dermatologists accompanied by measuring skin biophysical characteristics including cutaneous resonance running time (CRRT) and transepidermal water loss (TEWL). Moreover, possible adverse effects, downtime, and patients' satisfaction were recorded at baseline, 1 month after each treatment, and 3 months after the last treatment session. The protocol was approved by the Iranian Registry of Clinical Trials (IRCT20160820029436N3).
RESULTS


Of the 32 selected volunteers, 24 subjects completed the study. The clinical assessment showed a significant improvement of the face appearance along with a significant reduction in dyschromia, and periorbital wrinkling (P-value < .05), with both procedures without any considerable difference between two methods. Moreover, the patients showed substantial satisfaction with both modalities with no statistically significant difference. Mean TEWL and CRRT values also decreased significantly in both groups with no considerable difference. The downtime was significantly shorter in the microneedling-treated side. There were no long-lasting or severe adverse effects after treatment with both methods.
CONCLUSION


Microneedling and fractional Er:YAG laser have comparable efficacy in facial rejuvenation, but little downtime of the former makes it preferable for many patients.",2020,Mean TEWL and CRRT values also decreased significantly in both groups with no considerable difference.,"['24 subjects completed the study', '32 selected volunteers', 'facial rejuvenation']","['fractional Er:YAG laser and one with microneedling', 'microneedling versus fractional Er:YAG laser', 'microneedling with fractional Er:YAG']","[""adverse effects, downtime, and patients' satisfaction"", 'downtime', 'skin biophysical characteristics including cutaneous resonance running time (CRRT) and transepidermal water loss (TEWL', 'dyschromia, and periorbital wrinkling (P-value', 'Microneedling and fractional', 'long-lasting or severe adverse effects', 'Mean TEWL and CRRT values']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",32.0,0.0858563,Mean TEWL and CRRT values also decreased significantly in both groups with no considerable difference.,"[{'ForeName': 'Reza M', 'Initials': 'RM', 'LastName': 'Robati', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Hamedani', 'Affiliation': 'Department of Dermatology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Namazi', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Niknejad', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Gheisari', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13440']
66,32369281,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Dalerba', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
67,32369283,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Havlichek', 'Affiliation': 'Michigan State University, East Lansing, MI havliche@msu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
68,32369284,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corrao', 'Affiliation': 'University of Palermo School of Medicine, Palermo, Italy s.corrao@tiscali.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Natoli', 'Affiliation': 'ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cacopardo', 'Affiliation': 'University of Catania School of Medicine, Catania, Italy.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
69,32369285,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Carmona-Bayonas', 'Affiliation': 'Hospital Universitario Morales Meseguer, Murcia, Spain alberto.carmonabayonas@gmail.com.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jimenez-Fonseca', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castañón', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
70,32369282,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Kunz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA kkunz@sas.upenn.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
71,32364350,Effects of kinesiology tape after enucleation of mandibular dentigerous cysts.,"Objectives


Kinesiology tape (KT) creates a pulling force on the skin, thus improving blood and lymph flow by alleviating hemorrhage and congestion of lymphatic fluid. The authors hypothesized that the use of KT could be beneficial for the management of complications after head and neck surgery and designed this study to evaluate the effects of KT on swelling, pain, and trismus after enucleation of mandibular dentigerous cysts with third molar extraction.
Materials and Methods


Forty patients who underwent enucleation of a dentigerous cyst with extraction of the mandibular third molar were selected. The patients were randomized into two groups (n=20 each): a KT group, where KT was applied after surgery in addition to basic postoperative care, and a control group, where patients received basic postoperative care without KT application. Swelling, pain, and trismus were evaluated before surgery (T0) and on postoperative days 1 (T1), 2 (T2), and 3 (T3). Cyst volume, gauze weight for assessing bleeding, and operation time were recorded.
Results


There was a significant difference between the two groups in the change in swelling up to T1 and the change in swelling between T1 and T2. The maximum swelling in the KT group was significantly less than that in the No-KT group and maximum swelling appeared faster in the KT group than in the No-KT group. Both groups showed a mild pain response but there was no significant difference between the two groups. There was no significant difference on interincisal distance change between the two groups. There were no correlations between cyst volume, bleeding, operation time, and maximum swelling.
Conclusion


KT can effectively manage facial swelling after oral and maxillofacial surgeries such as cyst enucleation and third molar extraction, thus improving postoperative patient satisfaction levels and quality of life.",2020,There was a significant difference between the two groups in the change in swelling up to T1 and the change in swelling between T1 and T2.,"['Forty patients who underwent enucleation of a dentigerous cyst with extraction of the mandibular third molar were selected', 'mandibular dentigerous cysts']","['basic postoperative care without KT application', 'Kinesiology tape (KT', 'KT', 'kinesiology tape']","['facial swelling', 'change in swelling up to T1 and the change in swelling', 'maximum swelling', 'mild pain response', 'postoperative patient satisfaction levels and quality of life', 'cyst volume, bleeding, operation time, and maximum swelling', 'swelling, pain, and trismus', 'Swelling, pain, and trismus', 'interincisal distance change', 'Cyst volume, gauze weight for assessing bleeding, and operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0011428', 'cui_str': 'Dentigerous cyst'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",40.0,0.0448326,There was a significant difference between the two groups in the change in swelling up to T1 and the change in swelling between T1 and T2.,"[{'ForeName': 'Min-Gyu', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, Dankook University, Cheonan, Korea.'}, {'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, Dankook University, Cheonan, Korea.'}]",Journal of the Korean Association of Oral and Maxillofacial Surgeons,['10.5125/jkaoms.2020.46.2.108']
72,32360692,Acute and residual mood and cognitive performance of young adults following smoked cannabis.,"OBJECTIVES


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


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


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


Under the present experimental conditions, in young regular cannabis users, smoking cannabis ad libitum had significant effects on mood, some of which persisted 24 h later, yet minimal effects on cognition, and no evidence of residual cognitive impairment.",2020,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","['young adult regular cannabis users following smoked cannabis', 'Ninety-one healthy young adults', 'young adults following smoked cannabis', 'young regular cannabis users']","['High and Low', 'Placebo', 'placebo cannabis with a 2:1 allocation ratio, and mood', 'placebo']","['Confusion, Friendliness, and Elation', 'blood THC concentrations', 'Fatigue', 'Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB', 'Friendliness and Elation', 'Acute and residual mood and cognitive performance', 'POMS Arousal and Positive Mood', 'DSST performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3490329', 'cui_str': 'glycerol phenylbutyrate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",91.0,0.263829,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada. Electronic address: justin.matheson@camh.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S3M2, Canada; Pharmacy Department, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario M6J1H4, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, 1020 Walnut Street, Philadelphia, PA 19107, United States.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': ""Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario M5S 1A8, Canada.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario M5G 1V7, Canada.""}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Controlled Substances and Cannabis Directorate, Health Canada, Ottawa, Ontario, Canada.""}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172937']
73,32358782,Symptom Management Among Cancer Survivors: Randomized Pilot Intervention Trial of Heart Rate Variability Biofeedback.,"Chronic cancer-related symptoms (stress, fatigue, pain, depression, insomnia) may be linked with sympathetic nervous system over-activation and autonomic imbalance. Decreased heart rate variability (HRV) is an indicator of autonomic dysregulation that is commonly observed among cancer survivors. HRV biofeedback (HRVB) training induces HRV coherence, which maximizes HRV and facilitates autonomic and cardiorespiratory homeostasis. This randomized, wait-list-controlled, pilot intervention trial tested the hypothesis that HRVB can improve HRV coherence and alleviate cancer-related symptoms. The intervention group (n = 17) received 4-6 weekly HRVB training sessions until participants demonstrated skill acquisition. Controls (n = 17) received usual care. Outcomes assessed at baseline and follow-up included 15-min HRV recordings (HRV Coherence Ratio), and symptoms of: stress, distress, post-traumatic stress disorder (PTSD), pain, depression, fatigue, and sleep disturbance. Linear mixed models for repeated measures were used to assess Group-by-Time interactions, pre- versus post-treatment differences in mean symptom scores, and group differences at follow-up. Mean HRV Coherence Ratios (± standard error) improved in the HRVB group at follow-up (baseline: 0.37 ± 0.05, post-intervention: 0.84 ± 0.18, p = 0.01), indicating intervention validity. Statistically significant Group-by-Time interactions indicated treatment-related improvements in HRV Coherence Ratios (p = 0.03, Pre-vs. post-treatment effect size [Cohen's d]: 0.98), sleep symptoms (p = 0.001, d = 1.19), and sleep-related daytime impairment (p = 0.005, d = 0.86). Relative to controls, the intervention group experienced trends toward improvements in stress, distress, fatigue, PTSD, and depression, although no other statistically significant Group-by-Time interactions were observed. This pilot intervention found that HRVB training reduced symptoms of sleep disturbance among cancer survivors. Larger-scale interventions are warranted to further evaluate the role of HRVB for managing symptoms in this population. Registration: NCT03692624 www.clinicaltrials.gov.",2020,"Statistically significant Group-by-Time interactions indicated treatment-related improvements in HRV Coherence Ratios (p = 0.03, Pre-vs. post-treatment effect size [Cohen's d]: 0.98), sleep symptoms (p = 0.001, d = 1.19), and sleep-related daytime impairment (p = 0.005, d = 0.86).","['cancer survivors', 'Cancer Survivors']","['HRV biofeedback (HRVB) training', '4-6 weekly HRVB training sessions until participants demonstrated skill acquisition', 'usual care', 'HRVB', 'HRVB training']","['Mean HRV Coherence Ratios (±\u2009standard error', 'Chronic cancer-related symptoms (stress, fatigue, pain, depression, insomnia', 'sleep symptoms', 'stress, distress, fatigue, PTSD, and depression', 'symptoms of sleep disturbance', 'sleep-related daytime impairment', 'mean symptom scores', 'HRV coherence and alleviate cancer-related symptoms', 'heart rate variability (HRV', '15-min HRV recordings (HRV Coherence Ratio), and symptoms of: stress, distress, post-traumatic stress disorder (PTSD), pain, depression, fatigue, and sleep disturbance', 'HRV Coherence Ratios']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0532124,"Statistically significant Group-by-Time interactions indicated treatment-related improvements in HRV Coherence Ratios (p = 0.03, Pre-vs. post-treatment effect size [Cohen's d]: 0.98), sleep symptoms (p = 0.001, d = 1.19), and sleep-related daytime impairment (p = 0.005, d = 0.86).","[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Burch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA. burch@mailbox.sc.edu.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'McLain', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Stokes', 'Affiliation': 'Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Susko', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hendry', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Crowley', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Christ', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hanna', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': ""O'Rourke"", 'Affiliation': 'Integrative Oncology, PRISMA Health Upstate Cancer Institute, Greenville, SC, USA.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09462-3']
74,32300790,"Response to Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],[],[],[],[],[],,0.0185509,,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa209']
75,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND


Down Syndrome (DS) is a genetic condition presenting delay in acquisition of main motor milestones, such as walking. Although studies have been investigating the biomechanical parameters during land walking performed by individual with DS, the literature is scarce regarding kinetic parameters analysis in this population, specially during water walking.
RESEARCH QUESTION


This study sought to assess the vertical ground reaction force (Fz) of walking performed in water and on land at different speeds by individuals with DS.
METHODS


Fourteen adults with DS (age: 27.9 ± 7.9 years; body mass: 58.4 ± 12.9 kg; height: 1.4 ± 0.1 m, body mass index: 29.2 ± 5.4 kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment. The protocol consisted of walking performed at three self-selected speeds (slow, comfortable and fast) in randomized order. The Fz was assessed with a waterproof force plate in each condition. Two-way repeated-measures ANOVA (environment and speed), with Bonferroni's post hoc tests, were used for analysis. A significance level was set as α = 0.05.
RESULTS


Significant differences were observed between environments (p < 0.001), with reduced first peak of Fz (68-73%), second peak of Fz (66-70%), loading rate (75-78%) and impulse (40-41%) in the water walking for all speeds analyzed. In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking. Moreover, the loading rate significantly increased (p = 0.019) as the impulse significantly reduced (p < 0.001) in the higher speeds.
SIGNIFICANCE


Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
76,32298839,Progress of the ALIFE2 study: A dynamic road towards more evidence.,"Investigator-initiated studies are invaluable, especially in fields that are not particularly of interest for the pharmaceutical industry because they are either less profitable or concern special patient groups such as pregnant women. However, designing, conducting, and completing an investigator-initiated randomised controlled trial is challenging. Patients and physicians' preferences, ethics requirements, (international) legislation and funding are all areas where such challenges are encountered. The Anticoagulants for LIving FEtuses (ALIFE)2 study (NTR3361) is an example of an investigator initiated international multicenter trial that progresses slowly, at least initially, as many challenges had to be overcome. Here, we discuss the challenges we faced during the course of the ALIFE2 study up till now and we explain how some of these challenges can be tackled or even avoided.",2020,The Anticoagulants for LIving FEtuses,"['pregnant women', 'LIving FEtuses']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}]",[],[],,0.0353679,The Anticoagulants for LIving FEtuses,"[{'ForeName': 'Eva N', 'Initials': 'EN', 'LastName': 'Hamulyák', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: e.n.hamulyak@amsterdamumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'de Jong', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Luuk J J', 'Initials': 'LJJ', 'LastName': 'Scheres', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Ewington', 'Affiliation': 'Warwick Medical School, University Hospitals Coventry and Warwickshire NHS trust, Coventry, United Kingdom.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Middeldorp', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Warwick Medical School, University Hospitals Coventry and Warwickshire NHS trust, Coventry, United Kingdom.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.03.015']
77,32304911,"60 mg dose ticagrelor provides stronger platelet inhibition than clopidogrel in Chinese patients with chronic coronary syndrome: A randomized, single-blind, crossover study.",,2020,,['Chinese patients with chronic coronary syndrome'],"['clopidogrel', 'ticagrelor']",['platelet inhibition'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0257739,,"[{'ForeName': 'Meijiao', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Danghui', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China. Electronic address: kongyihui@126.com.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China; Institute of Metabolic Disease, Heilongjiang Academy of Medical Science, Harbin, People's Republic of China. Electronic address: ly99ly@vip.163.com.""}]",Thrombosis research,['10.1016/j.thromres.2020.03.014']
78,32304630,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30309-1']
79,32363592,"Effects of Alcohol Cue Reactivity on Subsequent Treatment Outcomes Among Treatment-Seeking Individuals with Alcohol Use Disorder: A Multisite Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline.","BACKGROUND


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


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


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


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


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


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Treloar Padovano', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ryan', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Joanne B', 'Initials': 'JB', 'LastName': 'Fertig', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Chun', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Srinivas B', 'Initials': 'SB', 'LastName': 'Muvvala', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14352']
80,32363610,Combined methazolamide and theophylline improves oxygen saturation but not exercise performance or altitude illness in acute hypobaric hypoxia.,"NEW FINDINGS


What is the central question of this study? Does the combination of methazolamide and theophylline reduce symptoms of acute mountain sickness (AMS) and improve aerobic performance in acute hypobaric hypoxia? What is the main finding and its importance? The oral combination of methazolamide (100 BID) and theophylline (300 BID) improved arterial oxygen saturation but did not reduce symptoms of AMS and impaired aerobic performance. We do not recommend this combination of drugs for prophylaxis against the acute negative effects of hypobaric hypoxia.
ABSTRACT


A limited number of small studies have suggested that methazolamide and theophylline can independently reduce symptoms of acute mountain sickness (AMS) and, if taken together, can improve aerobic exercise performance in normobaric hypoxia. We performed a randomized, double-blind, placebo-controlled, cross-over study to determine if the combination of oral methazolamide and theophylline could provide prophylaxis against AMS and improve aerobic performance in hypobaric hypoxia (∼4875 m). Volunteers with histories of AMS were screened at low altitude (1650 m) and started combined methazolamide (100 mg BID) and theophylline (300 mg BID) treatment, or placebo, 72 h prior to decompression. Baseline AMS (Lake Louise Questionnaire), blood (haemoglobin, haematocrit), cognitive function, ventilatory and pulse oximetry (  S   p   O   2        ) measures were assessed at low altitude and repeated between 4 and 10 h of exposure to hypobaric hypoxia (P B   = 425 mmHg). Aerobic exercise performance was assessed during a 12.5 km cycling time trial (TT) after 4 h of hypobaric hypoxia. Subjects repeated all experimental procedures after a 3-week washout period. Differences between drug and placebo trials were evaluated using repeated measures ANOVA (α = 0.05). The drugs improved resting  S   p   O   2        by ∼4% (P < 0.01), but did not affect the incidence or severity of AMS or cognitive function scores relative to placebo. Subjects' performance on the 12.5 km TT was ∼3% worse when taking the drugs (P < 0.01). The combination of methazolamide and theophylline in the prescribed dosages is not recommended for use at high altitude as it appears to have no measurable effect on AMS and can impair aerobic performance.",2020,"Subjects' performance on the 12.5 km TT was ∼3% worse when taking the drugs (P < 0.01).
","['Volunteers with histories of AMS were screened at low altitude (1650\xa0m) and', 'acute hypobaric hypoxia']","['methazolamide and theophylline', 'started combined methazolamide', 'theophylline', 'methazolamide', 'placebo']","['Baseline AMS (Lake Louise Questionnaire), blood (hemoglobin, hematocrit), cognitive function, ventilatory, and pulse oximetry (SpO 2  ) measures', 'symptoms of AMS and impaired aerobic performance', 'aerobic exercise performance', 'oxygen saturation', 'Aerobic exercise performance', 'arterial oxygen saturation', 'aerobic performance', 'incidence or severity of AMS or cognitive function scores']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0238618', 'cui_str': 'Low altitude'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}]","[{'cui': 'C0025631', 'cui_str': 'Methazolamide'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0953803,"Subjects' performance on the 12.5 km TT was ∼3% worse when taking the drugs (P < 0.01).
","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Subudhi', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Oghenero', 'Initials': 'O', 'LastName': 'Evero', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Reitinger', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gronewold', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nichols', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Sonja Jameson', 'Initials': 'SJ', 'LastName': 'Van-Houten', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Roach', 'Affiliation': 'Altitude Research Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",Experimental physiology,['10.1113/EP088461']
81,32374527,A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.,"OBJECTIVE


In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss.
METHODS


Participants (N = 180; BMI = 33.2 ± 6.0 kg/m 2  ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes.
RESULTS


Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η 2   = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
CONCLUSIONS


Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.",2020,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","['young adults', 'Participants (N\u2009=\u2009180; BMI\u2009=\u200933.2\u2009±\u20096.0 kg/m 2  ', 'young adults and older adults', 'young adults fare worse than older adults', 'Young adults (n\u2009=\u200928) were also compared with older adults (ages 36-70; n\u2009=\u2009152) on these outcomes', 'young adults (ages 18-35) in IBWL (n\u2009=\u200916) with young adults in IBWL\u2009+\u2009$ (n\u2009=\u200912) on percent weight loss, engagement, and retention']","['technology-based BWL', 'IBWL or IBWL\u2009+\u2009incentives (IBWL\u2009+\u2009$) group', 'traditional behavioral weight loss (BWL) programs']","['weight loss', 'retention or weight loss']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0386472,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Services, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reading', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, Miriam Hospital, Providence, Rhode Island, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22797']
82,32361032,Ethnicity moderates outcome in family focused treatment for pediatric obsessive compulsive disorder.,"OBJECTIVE


This study examined predictors and moderators of treatment outcome in a randomized controlled trial (RCT) comparing two active interventions for pediatric obsessive compulsive disorder that differed with respect to the focus and format of family intervention. We had a particular interest in the role of race/ethnicity in shaping outcomes given our relatively diverse sample composition and the limited prior work in this area.
METHOD


A total of 62 youths (Mean age = 12.71 years; 57 % male; 34 % non-white) were assigned to either a standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET). Treatment in both arms involved 12 sessions of exposure therapy; the family interventions differed. Predictor and moderator variables were chosen based on the extant literature.
RESULTS


Minority status did not predict outcome, suggesting that overall, white and non-white youth had comparable treatment response. Race/ethnicity did, however, moderate response with non-white youth faring better in the ET arm of the study. In particular, minority youth in ET had, on average, post-treatment CYBOCS scores consistent with clinical remission whereas their ST counterparts were left with symptoms considered moderately severe. There were no predictors of treatment outcome.
CONCLUSIONS


Minority status predicts poorer response to standard CBT across disorders, suggesting the need for possible treatment adaptations. The present findings highlight one avenue for matching patients to treatments that might optimize outcomes and underscore the value of family involvement in OCD treatment.",2020,"There were no predictors of treatment outcome.
","['pediatric obsessive compulsive disorder', '62 youths (Mean age\u2009=\u200912.71 years; 57 % male; 34 % non-white']",['standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]",[],62.0,0.0176714,"There were no predictors of treatment outcome.
","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, United States.'}, {'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Pennsylvania State University, United States.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'University of Arizona, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102229']
83,32361196,Progressive Muscle Relaxation and guided imagery as techniques to enhance the way of coping of parents of children with malignancies: Findings from a randomized controlled trial.,"PURPOSE


The aim of this study was to test the effectiveness of relaxation techniques in altering the coping strategies that were employed by the parents of children with malignancy on active treatment.
METHODS


It was a randomized non-blinded controlled trial, including pre - and post assessments, comparing a 3-week relaxation intervention with the standard psychological care. Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece. Fifty four parents of children hospitalized with a malignancy, were randomly assigned either to the intervention group (n = 29), receiving the Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n = 25) receiving only the Standard Psychological Care by nurses and psychologists. Data were collected with the Questionnaire of 'Ways of Coping Checklist' (WofCC).
RESULTS


The results showed that the intervention did not have an impact on the coping strategies that parents employed as these are reflected on the WofCC' factors. The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming.
CONCLUSIONS


The findings did not support the utilization of PMR and GI as coping strategies altering interventions in this clinical context. However, these findings should be interpreted in light of the short duration of the intervention that under these specific circumstances might have required a more lengthy approach for coping strategies to be altered. Furthermore, the stress relieving properties of these interventions could fortify (although not altering) existing coping strategies.",2020,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming.
","['parents of children with malignancies', 'parents of children with malignancy on active treatment', 'Fifty four parents of children hospitalized with a malignancy', 'Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece']","['Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n\xa0=\xa025) receiving only the Standard Psychological Care by nurses and psychologists', 'Progressive Muscle Relaxation and guided imagery', 'relaxation intervention with the standard psychological care']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0587491', 'cui_str': 'Hematology department'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0307766,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming.
","[{'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: theologia.tsitsi@cut.ac.cy.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Raftopoulos', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Mediterranean Research Centre for Public Health and Quality of Care, Limassol, Cyprus. Electronic address: vraftop1@gmail.com.'}, {'ForeName': 'Evridiki', 'Initials': 'E', 'LastName': 'Papastavrou', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: e.papastavrou@cut.ac.cy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Research Centre for Oncology and Palliative Care, Limassol, Cyprus. Electronic address: andreas.charalambous@cut.ac.cy.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101718']
84,32369401,Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.,"PURPOSE


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


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


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


To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.",2020,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM  v  85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05];  P  = .18).","['Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months', 'Women', '724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline']","['text messaging (TM) versus no text messaging (No-TM', 'Adjuvant Aromatase Inhibitor Therapy', 'Text Messaging']","['time to AF', 'time to adherence failure (AF', 'rates of AI AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",724.0,0.166451,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM  v  85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05];  P  = .18).","[{'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Grace Clarke', 'Initials': 'GC', 'LastName': 'Hillyer', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP/Cancer Center of Kansas - Wichita, Wichita, KS.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Esparaz', 'Affiliation': 'Heartland NCORP/Cancer Care Specialist of Central Illinois, Decatur, IL.'}, {'ForeName': 'Ming C', 'Initials': 'MC', 'LastName': 'Kuan', 'Affiliation': 'Kaiser Permanente NCORP/Kaiser Permanente NCAL, San Leandro, CA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Southeast COR NCORP/Waverly Hematology/Oncology, Cary, NC.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Lackowski', 'Affiliation': 'Northwest NCORP/Central Interstate Medical Office Department Hematology/Oncology, Portland, OR.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Edenfield', 'Affiliation': 'NCORP of the Carolinas (Greenville Health System), Greenville, SC.'}, {'ForeName': 'Zoneddy R', 'Initials': 'ZR', 'LastName': 'Dayao', 'Affiliation': 'New Mexico Minority Underserved NCORP/University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance/University of Washington, Seattle, WA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Ramsey', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alfred I', 'Initials': 'AI', 'LastName': 'Neugut', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02699']
85,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND


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


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


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


These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015']
86,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS


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


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


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


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


ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c  7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
87,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3  supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal']","['vitamin D supplements', 'vitamin D 3  supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687']
88,32374030,Bioequivalence of macitentan and tadalafil given as fixed-dose combination or single-component tablets in healthy subjects.,"AIMS


To demonstrate the bioequivalence of macitentan/tadalafil fixed-dose combination (FDC) tablets with single-component tablets of macitentan and tadalafil in healthy subjects.
METHODS


Studies AC-077-101 and AC-077-103 were single-centre, open-label, single-dose, 2-period, randomized, crossover Phase 1 studies conducted in healthy subjects. Two FDCs were investigated: FDC-1 and FDC-2 in Study AC-077-101 and FDC-2 in Study AC-077-103. Both FDCs contained 10 mg/40 mg of macitentan/tadalafil and differed in excipients and coating materials used. In both studies, pharmacokinetic sampling over 216 hours was conducted, and pharmacokinetic parameters were derived using noncompartmental methods.
RESULTS


Bioequivalence of macitentan, its active metabolite ACT-132577, and tadalafil was established for FDC-2 in both studies AC-077-101 and AC-077-103 in which tadalafil as a single component was sourced from the USA and EU, respectively, to fulfil regional regulatory requirements. The area under the plasma concentration-time curve and maximum plasma concentration with 90% confidence intervals of all components were entirely within the bioequivalence limits (0.8000-1.2500). No subject died and no serious adverse events were reported in either studies.
CONCLUSION


The FDC-2 tablet containing 10 mg/40 mg of macitentan/tadalafil was bioequivalent to the free combination of 10 mg macitentan and 40 mg tadalafil (both US and EU sourced). Macitentan and tadalafil were well tolerated when administered as FDC or as a free combination.",2020,"No subject died and no serious adverse events were reported in either studies.
","['Studies AC-077-101 and AC-077-103 were single-center', 'healthy subjects', 'Healthy Subjects']","['tadalafil', 'macitentan/tadalafil', 'tadalafil fixed-dose combination (FDC) tablets with single-component tablets of macitentan and tadalafil', 'Macitentan and Tadalafil']","['serious adverse events', 'area under the plasma concentration-time curve, and maximum plasma concentration']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C2606556', 'cui_str': 'Macitentan'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",2.0,0.0800154,"No subject died and no serious adverse events were reported in either studies.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grill', 'Affiliation': 'Actelion Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bruderer', 'Affiliation': 'Actelion Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Antonova', 'Affiliation': 'Aixial s.r.o., Brno, Czech Republic.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Globig', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': 'Reven, LLC., Golden, CO, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': 'Clinical Research Services Mannheim GmbH, Mannheim, Germany.'}, {'ForeName': 'Dénes', 'Initials': 'D', 'LastName': 'Csonka', 'Affiliation': 'Actelion Pharmaceuticals Ltd., Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14347']
89,32305380,Six-year results of a randomized controlled clinical trial of two glass ionomer cements in class II cavities.,"OBJECTIVES


Long-term survival of two highly viscous glass ionomer cements (Fuji IX GP Fast and Equia Fil) over a period of 6 years in vivo.
METHODS


A total of 85 two- or three-surface class II restorations, comprising 43 Equia Fil / Equia Coat and 42 Fuji IX GP Fast / Fuji Coat LC, were placed in 34 patients. The restorations were re-evaluated after 6 years using the FDI criteria. The statistical analysis was performed with Fisher's exact test, the Wilcoxon signed-rank test, the Mann-Whitney U test and the Kaplan-Meier method.
RESULTS


Forty-four restorations (22 Equia Fil and 22 Fuji IX GP Fast) could be assessed at the 6-year follow-up. During the whole study period, eight failures, four for each material, were observed. The main reasons for failure were material fractures and retention loss, which were partly combined with poor marginal adaptation or poor proximal anatomical form. Two failures may be attributed to insufficient application of the materials, as suspected according to the radiographs. The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907). During the period from 3 to 6 years, only one filling in each group failed.
CONCLUSION


Both materials showed acceptable and comparable survival rates after 6 years.
CLINICAL SIGNIFICANCE


Highly viscous glass ionomer cement can be an acceptable restoration material for smaller class II cavities.",2020,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,['two glass ionomer cements in class II cavities'],[],['survival rates'],"[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0247799,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany. Electronic address: kheck@dent.med.uni-muenchen.de.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Diegritz', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Manhart', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hickel', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotiadou', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103333']
90,30862961,Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.,"BACKGROUND


The Induced Hypothermia (IH) and Optimizing Cooling (OC) trials for hypoxic-ischemic encephalopathy (HIE) had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials.
METHODS


We compared pre/post-randomization characteristics and care practices between IH and OC.
RESULTS


There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5 °C for 72 h. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO 2  (+3.08 mmHg, p = 0.005) and highest PO 2  (-82.7 mmHg, p < 0.001). In OC, compared to IH, the adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p = 0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR 1.86 (1.21-2.86), p = 0.005).
CONCLUSION


Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials.",2019,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","['208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5\u2009°C for 72\u2009h']",['Induced Hypothermia (IH) and Optimizing Cooling (OC'],"['IH and OC', 'adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization', 'risk of exposure during cooling to sedatives/analgesia', 'rate of death/moderate-severe disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.205879,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","[{'ForeName': 'Sonia L', 'Initials': 'SL', 'LastName': 'Bonifacio', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA. soniab1@stanford.edu.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Valerie Y', 'Initials': 'VY', 'LastName': 'Chock', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Wusthoff', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Brown University, Providence, RI, USA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankara', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0371-2']
91,32371183,Optimization of CT windowing for diagnosing invasiveness of adenocarcinoma presenting as sub-solid nodules.,"PURPOSE


To evaluate the optimal window setting to diagnose the invasiveness of lung adenocarcinoma in sub-solid nodules (SSNs).
METHODS


We retrospectively included 437 SSNs and randomly divided them 3:1 into a training group (327) and a testing group (110). The presence of a solid component was regarded as indicator of invasiveness. At fixed window level (WL) of 35 Hounsfield Units (HU), two readers adjusted the window width (WW) in the training group and recorded once a solid component appeared or disappeared on CT images acquired at 120 kVp. The optimal WW cut-off value to differentiate between invasive and pre-invasive lesions, based on the receiver operating characteristic (ROC) curve, was defined as ""core"" WW. The diagnostic performances of the mediastinal window setting (WW/WL, 350/35 HU) and core window setting were then compared in the testing group.
RESULTS


Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS)], 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA)]. In training group, the core WW of 1175 HU was the optimal cut-off to detect solid components of SSNs (AUC:0.79). In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
CONCLUSION


At 120 kVp, core window setting (WW/WL, 1175/35 HU) outperformed the traditional mediastinal window setting to diagnose the invasiveness of SSNs.",2020,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","['lung adenocarcinoma in sub-solid nodules (SSNs', 'Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS', '437 SSNs', ' 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA']",['CT'],"['sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness']","[{'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0334001', 'cui_str': 'Atypical glandular hyperplasia'}, {'cui': 'C0334000', 'cui_str': 'Glandular hyperplasia'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1301821', 'cui_str': 'Social security number'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",233.0,0.0224966,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China; University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.""}, {'ForeName': 'Shuxuan', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, the Netherlands.'}, {'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Yingru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Institute for Diagnostic Accuracy (iDNA) BV, Groningen, the Netherlands; University of Groningen, Faculty of Medical Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China. Electronic address: yezhaoxiang@163.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.108981']
92,32371199,Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.,"BACKGROUND


Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes.
DESIGN


The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed.
RESULTS


There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
CONCLUSIONS


Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation.
TRIAL REGISTRATION


ClinicalTrials.govNCT01913522.",2020,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
",['346 patients enrolled in'],"['implantable cardiac monitor', 'CIRCA-DOSE']","['AF burden, and post-ablation arrhythmia outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",346.0,0.0501133,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada; Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': 'Robert R J', 'Initials': 'RRJ', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""St. Mary's Hospital, Kitchener, Canada.""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'St. Boniface Hospital, Winnipeg, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Raymond', 'Affiliation': 'Centre Hospitalier Universitaire de Montreal, Université de Montréal, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Department of Medicine, Université Laval, Quebec, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Toronto General Hospital, University of Toronto, Toront006F, Canada.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Glover', 'Affiliation': 'Sunnybrook Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.008']
93,32371401,Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.,"INTRODUCTION


The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.
METHODS


A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days.
RESULTS


Between June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days.
CONCLUSION


The LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors.
TRIAL REGISTRATION NUMBER


ISRCTN86184521.",2020,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","['patients with chest pain', 'Between June 2018 and March 2019', 'Eligible adult patients presented with chest pain', 'emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown', '629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days', '632 patients were randomised; 3 were later withdrawn']","['MACE', 'LoDED strategy or the usual rule-out strategy', 'troponin discharge strategy']","['clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy', 'discharge from the hospital within 4\u2009hours of arrival, without a major adverse cardiac event (MACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",632.0,0.276477,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","[{'ForeName': 'Edward Watts', 'Initials': 'EW', 'LastName': 'Carlton', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK eddcarlton@gmail.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Research Design Service South West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Cardiology, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beresford', 'Affiliation': 'Biochemistry, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Reuben', 'Affiliation': 'Emergency Department, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Emergency Department, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Centre for Medical Statistics, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Jonathan Richard', 'Initials': 'JR', 'LastName': 'Benger', 'Affiliation': 'Academic Department of Emergency care, The University Hospitals NHS Foundation trust, Bristol, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316692']
94,32374826,"Response to Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],[],[],[],[],[],,0.0185509,,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa245']
95,32374850,"Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],"['Breakfast vs Dinner', 'High Diet-Induced Thermogenesis']",[],[],"[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.0175443,,"[{'ForeName': 'Ken K Y', 'Initials': 'KKY', 'LastName': 'Ho', 'Affiliation': ""The Garvan Institute of Medical Research, St. Vincent's Hospital and the University of New South Wales, Sydney, NSW Australia.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa244']
96,32372330,"Dose-dependent effects of netarsudil, a Rho-kinase inhibitor, on the distal outflow tract.","PURPOSE


To characterize the effects of netarsudil on the aqueous humor outflow tract distal to the trabecular meshwork (TM). We hypothesized that netarsudil increases outflow facility in eyes with and without circumferential ab interno trabeculectomy (AIT) that removes the TM.
METHODS


Sixty-four porcine anterior segment cultures were randomly assigned to groups with (n = 32) and without circumferential AIT (n = 32). Cultures were exposed to 0.1, 1, and 10 μM netarsudil (N = 8 eyes per concentration). For each concentration, IOP and vessel diameters were compared with their respective pretreatment baselines. Outflow tract vessel diameters were assessed by spectral-domain optical coherence tomography (SDOCT) and rendered in 4D (XYZ time series).
RESULTS


Netarsudil at 1 μM reduced IOP both in eyes with TM (- 0.60 ± 0.24 mmHg, p = 0.01) and in eyes without TM (- 1.79 ± 0.42 mmHg, p < 0.01). At this concentration, vessels of the distal outflow tract dilated by 72%. However, at 0.1 μM netarsudil elevated IOP in eyes with TM (1.59 ± 0.36 mmHg, p < 0.001) as well as in eyes without TM (0.23 ± 0.32 mmHg, p < 0.001). Vessels of the distal outflow tract constricted by 31%. Similarly, netarsudil at a concentration of 10 μM elevated IOP both in eyes with TM (1.91 ± 0.193, p < 0.001) and in eyes without TM (3.65 ± 0.86 mmHg, p < 0.001). At this concentration, outflow tract vessels constricted by 27%.
CONCLUSION


In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels. Hyper- and hypotensive properties of netarsudil persisted after TM removal.",2020,"In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels.",['Sixty-four porcine anterior segment cultures'],['circumferential ab interno trabeculectomy (AIT'],"['Outflow tract vessel diameters', 'IOP', 'concentration, IOP and vessel diameters']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",64.0,0.0358014,"In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels.","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Waxman', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Atta', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Ralitsa', 'Initials': 'R', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany.'}, {'ForeName': 'Nils A', 'Initials': 'NA', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany. loewen.nils@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04691-y']
97,32375100,Effect of the Smart Moms intervention on targeted mediators of change in child sugar-sweetened beverage intake.,"OBJECTIVE


Few parent-targeted interventions have examined the mechanisms of action by which the intervention changes child behavior. The purpose of this study was to test the theoretical and behavioral mediators of the Smart Moms intervention on changes in child sugar-sweetened beverage and juice (SSB/juice) consumption.
STUDY DESIGN


This is a secondary mediation analysis of data from a 6-month randomized controlled trial (N = 51 mother-child dyads) of a mobile phone-based program to reduce child SSB/juice intake compared with a waitlist control group.
METHODS


Linear mixed models compared changes in intervention targets from baseline to 3 months between treatment groups. Intervention targets that changed significantly between groups were tested in a multiple mediation model to evaluate their significance as mediators of change in child SSB/juice at 6 months.
RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months. There were few mediators of the intervention on child SSB/juice change.
CONCLUSION


Greater longitudinal research is needed to understand predictors of child dietary changes to inform future intervention efforts. In addition, a greater focus on the measurement of theoretical constructs in family-based child obesity prevention research is needed.",2020,"RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months.",['child sugar-sweetened beverage intake'],"['mobile phone-based program to reduce child SSB/juice intake compared with a waitlist control group', 'Smart Moms intervention']",['child SSB/juice change'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",51.0,0.0406914,"RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months.","[{'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA. Electronic address: bnezami@unc.edu.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Lytle', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA; Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: llytle@email.unc.edu.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA. Electronic address: dsward@email.unc.edu.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Ennett', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: sennett@email.unc.edu.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA; Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: dtate@unc.edu.'}]",Public health,['10.1016/j.puhe.2020.03.015']
98,32372078,Follicular-phase endometrial scratching: a truncated randomized controlled trial.,"STUDY QUESTION


Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
SUMMARY ANSWER


CPR did not vary between the endometrial injury and the control group, but the trial was underpowered due to early termination because of a higher clinical miscarriage rate observed in the endometrial injury arm after a prespecified interim analysis.
WHAT IS KNOWN ALREADY


Intentional endometrial injury has been put forward as an inexpensive clinical tool capable of enhancing endometrial receptivity. However, despite its widespread use, the benefit of endometrial scratching remains controversial, with several recent randomized controlled trials (RCTs) being unable to confirm its added value. So far, most research has focused on endometrial scratching during the luteal phase of the cycle preceding the one with embryo transfer (ET), while only a few studies investigated in-cycle injury during the follicular phase of OS. Also, the persistence of a scratch effect in subsequent treatment cycles remains unclear and possible harms have been insufficiently studied.
STUDY DESIGN, SIZE, DURATION


This RCT was performed in a tertiary hospital setting between 3 April 2014 and 8 October 2017. A total of 200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group.The primary outcome was CPR. Secondary outcomes included biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes within 6 months of the study cycle.
MAIN RESULTS AND THE ROLE OF CHANCE


The RCT was stopped prematurely by the trial team after the second prespecified interim analysis raised safety concerns, namely a higher clinical miscarriage rate in the intervention group. The intention-to-treat CPR was similar between the biopsy and the control arm (respectively, 44 versus 40%, P = 0.61, risk difference = 3.6 with 95% confidence interval = -10.1;17.3), as was the LBR (respectively, 32 versus 36%, P = 0.52). The incidence of a biochemical pregnancy loss was comparable between both groups (10% in the intervention group versus 15% in the control, P = 0.49), but clinical miscarriages occurred significantly more frequent in the biopsy group (25% versus 8%, P = 0.032). In the intervention group, 3% of the patients experienced excessive procedure pain and 5% bleeding. The cumulative LBR taking into account all conceptions (spontaneous or following ART) within 6 months of randomization was not significantly different between the biopsy and the control group (54% versus 60%, respectively, P = 0.43).
LIMITATIONS, REASONS FOR CAUTION


The trial was stopped prematurely due to safety concerns after the inclusion of 200 of the required 360 patients. Not reaching the predefined sample size implies that definite conclusions on the outcome parameters cannot be drawn. Furthermore, the pragmatic design of the study may have limited the detection of specific subgroups of women who may benefit from endometrial scratching.
WIDER IMPLICATIONS OF THE FINDINGS


Intentional endometrial injury during the follicular phase of OS warrants further attention in future research, as it may be harmful. These findings should be taken in consideration together with the growing evidence from other RCTs that scratching may not be beneficial.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by 'Fonds Wetenschappelijk Onderzoek' (FWO, Flanders, Belgium, 11M9415N, 1524417N). None of the authors have a conflict of interest to declare with regard to this study.",2020,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","['Intentional endometrial injury during the follicular phase of OS warrants', 'tertiary hospital setting between 3 April 2014 and 8 October 2017', '200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included', 'Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group', 'Follicular-phase endometrial scratching']",[],"['biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes', 'clinical miscarriage rate', 'clinical pregnancy rate (CPR', 'LBR', 'cumulative LBR taking into account all conceptions (spontaneous or following ART', 'CPR', 'intention-to-treat CPR', 'incidence of a biochemical pregnancy loss', 'clinical miscarriages', 'excessive procedure pain and 5% bleeding']","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]",[],"[{'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.266451,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Van de Velde', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drakopoulos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stoop', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Reproductive Medicine, IVI-RMA Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa018']
99,32375722,Is body image a predictor of women's depression and anxiety in postmenopausal women?,"BACKGROUND


Women in perimenopausal and postmenopausal period are at increased risk of depression and anxiety. Physiologic changes in menopause can change body's appearance and function that may disturb body and then lead to anxiety and depression. This study aims to assess the relationship between body image with anxiety and depression among postmenopausal women.
METHODS


This descriptive study was performed on 307 women attending to the health centers in Tehran- Iran. Sampling was performed by a multi-staged randomized method. Data were collected by using Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires. Data were analyzed by SPSS 21 and using t-test, Pearson and Spearman correlation tests and multiple linear regression methods.
RESULTS


The average age of the participants was 55.19 ± 4.034 years. Mean scores for body image, anxiety and depression were 163.26 ± 20.38, 12.00 ± 7.71 and 42.70 ± 8.40 respectively. Fifty five percent of women had mild to severe depression and 83.7% of them had mild to severe anxiety. Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001). Multiple linear correlation showed that body image is a predictor for depression and anxiety (P < 0.001).
CONCLUSIONS


Body image of women can be effective on occurrence of depression and anxiety in menopause. Therefore, women's health policies should consider body image to control cognitive problems including depression and anxiety in menopause.",2020,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"['postmenopausal women', ""women's depression and anxiety in postmenopausal women"", '307 women attending to the health centers in Tehran- Iran']",[],"['Total score', 'severe depression', 'severe anxiety', 'Mean scores for body image, anxiety and depression', 'depression and anxiety scores', 'Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires', 'depression and anxiety']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",307.0,0.0537412,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Simbar', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Nazarpour', 'Affiliation': 'Department of Midwifery, Chalous Branch, Islamic Azad University, Chalous, Iran. sn_9547@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alavi Majd', 'Affiliation': 'Department of Biostatistics, School of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Dodel Andarvar', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jafari Torkamani', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alsadat Rahnemaei', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC psychiatry,['10.1186/s12888-020-02617-w']
100,32344324,"Cognitive Restructuring vs. Defusion: Impact on craving, healthy and unhealthy food intake.","Coping with food cravings is crucial for weight management. Individuals tend to use avoidance strategies to resist food cravings and prevent overeating, but such strategies may not result in the benefits sought. This study compared the effects of two cognitive techniques (Restructuring vs. Defusion) for dealing with food cravings in terms of their impact on healthy vs. unhealthy eating behavior (i.e., consumption of chocolate and/or carrots following the intervention). Sixty-five participants (M age  = 19.65 years) received either a 30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15 min of practice, or 45 min of obesity education and discussion (control). To examine craving and eating choices following the intervention, participants received bags of chocolate and carrots and were asked to carry these with them at all times over the next week, exchanging the bags every 2 days. Participants in the CD group ate fewer chocolates (M = 11.74) compared to CR (M = 17.06) and Control groups (M = 29.18) during the experimental week. The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates. CD resulted in fewer self-reported cravings compared to CR and CO groups. At a final taste test, both CD and CR groups ate significantly fewer chocolates compared to the CO group. CD appears to be an effective technique in managing food craving and to present some advantages over CR.",2020,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.",['Sixty-five participants (M age \xa0'],"['bags of chocolate and carrots', '30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15\xa0min of practice, or 45\xa0min of obesity education and discussion (control', 'CD', 'cognitive techniques (Restructuring vs. Defusion', 'Cognitive Restructuring vs. Defusion']",[],"[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],65.0,0.020642,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'University of Cyprus, Cyprus. Electronic address: mkarekla@ucy.ac.cy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Georgiou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sandoz', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'A Solomon', 'Initials': 'AS', 'LastName': 'Kurz', 'Affiliation': 'VISN 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Health Care System, United States of America.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'University of Nicosia, Cyprus.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101385']
101,32378072,Cetuximab Maintenance Therapy in Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer: A Single-Institute Prospective Study.,"INTRODUCTION


Cetuximab plus FOLFIRI (leucovorin, fluorouracil, and irinotecan) is the preferred first-line therapy for RAS and BRAF wild-type (RBWT) metastatic colorectal cancer (mCRC). To counter chemotherapy-induced side effects, use of maintenance therapy is suggested. Therefore, we evaluated the efficacy and safety of cetuximab maintenance therapy in patients after effective completion of first-line induction therapy.
METHODS


This prospective study enrolled untreated patients with mCRC RBWT who received first-line cetuximab plus FOLFIRI therapy. Following this, patients with treatment response either entered observation (stop treatment) or maintenance treatment 1 (cetuximab plus irinotecan) groups. After 6-12 cycles of maintenance treatment 1, patients entered maintenance treatment 2 (cetuximab only). If a patient progressed on maintenance 2, cetuximab plus FOLFIRI was reintroduced. The primary end point was failure-free survival (FFS), whereas the secondary end points included disease control rate (DCR), objective remission rate (ORR), and progression-free survival (PFS). Safety events were also evaluated.
RESULTS


Among 79 enrolled patients, 72 completed first-line treatment effectively (DCR 91.1%, ORR 63.9%) and 44 entered maintenance 1 [median PFS 1 (mPFS, maintenance 1) 6.1 months, 95% confidence interval (CI) 6.0-6.2; DCR 56.8%; ORR 22.7%]. Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3-14.1; DCR 28.6%; ORR 4.8%). Median FFS (mFFS) was significantly longer in the maintenance 1 group compared with the observation group [12.7 vs. 3.0 months; hazard ratio (HR) 0.202, 95% CI 0.111-0.369; P < 0.001]. Overall, mFFS was 19.0 and 9.3 months in maintenance and observation groups, respectively (HR 0.211, 95% CI 0.117-0.380; P < 0.001). Rash acneiform, mucositis, and asthenia were commonly observed adverse events during maintenance treatment.
CONCLUSION


Maintenance treatment with cetuximab after first-line therapy significantly improved FFS, with an acceptable safety profile in untreated patients with mCRC RBWT.
TRIAL REGISTRATION


Retrospectively registered, 2019/10/02, Chinese Clinical Trial Registry, ChiCTR number 1900026360.",2020,"Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3-14.1; DCR 28.6%; ORR 4.8%).","['untreated patients with mCRC RBWT', 'patients after effective completion of first-line induction therapy', 'enrolled untreated patients with mCRC RBWT who received', '79 enrolled patients, 72 completed first-line treatment effectively (DCR 91.1%, ORR 63.9%) and 44 entered maintenance\xa01', 'Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer', 'patients with treatment response either entered observation (stop treatment) or']","['cetuximab maintenance therapy', 'first-line cetuximab plus FOLFIRI therapy', 'Cetuximab Maintenance Therapy', 'maintenance treatment\xa01 (cetuximab plus irinotecan', 'Cetuximab plus FOLFIRI (leucovorin, fluorouracil, and irinotecan']","['disease control rate (DCR), objective remission rate (ORR), and progression-free survival (PFS', 'Rash acneiform, mucositis, and asthenia', 'failure-free survival (FFS', 'efficacy and safety', 'Safety events', 'FFS', 'Median FFS (mFFS']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",79.0,0.0395639,"Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3-14.1; DCR 28.6%; ORR 4.8%).","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Baoyu', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Dongta', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Mengxin', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Jinhuo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Peifeng', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China. linxiaoyan288@gmail.com.""}]",Advances in therapy,['10.1007/s12325-020-01360-8']
102,32378261,Transcutaneous Electrical Acustimulation Improves Gastrointestinal Disturbances Induced by Transcatheter Arterial Chemoembolization in Patients With Liver Cancers.,"BACKGROUND


Gastrointestinal (GI) disturbances occur in patients who receive chemotherapy via transcatheter arterial chemoembolization (TACE) and could last for an extended period of time in some cases. Antiemetic drugs have a potential risk of developing hepatic failure and are ineffective for delayed nausea and emesis. Transcutaneous electrical acustimulation (TEA) has recently been reported to exert antiemetic and prokinetic effects, but it is unknown whether it has an ameliorating effect on TACE-induced GI disturbances.
AIM


This study was designed to evaluate effects and mechanisms of noninvasive TEA on GI symptoms in patients treated with TACE.
MATERIALS AND METHODS


Seventy-four patients with liver cancers (eighteen female; age 63.4 ± 1.1 years) scheduled for TACE were randomized to TEA (n = 37) or sham-TEA (n = 37). TEA was performed via acupoints, ST36 and PC6 using parameters previously optimized for GI motility (1 h, bid) from the postoperative day 0 (POD0) to POD2. Sham-TEA was performed using the same parameters via non-acupoints. Symptom questionnaires were completed daily. The electrogastrogram (EGG) and electrocardiogram (ECG) were recorded in the fasting state for 30 mins to assess gastric slow waves and autonomic functions, respectively, before and after the 3-day treatment.
RESULTS


1) In the acute phase (<24 h), TEA showed no effects on any of GI symptoms, compared with sham-TEA. 2) In the delayed phase (>24 h), TEA, compared with sham-TEA, decreased the percentage of patients who experienced nausea on POD3 (0% vs. 13.5%, p = 0.021), the nausea score on POD3 (p = 0.022), the anorexia score on POD2 (p = 0.040) and POD3 (p = 0.004), and the bloating score (POD1-3: p < 0.01). 3) In comparison with sham-TEA, TEA increased the number of spontaneous bowel movements (p = 0.001) and the Bristol score of the first stool (p = 0.014) and decreased the number of patients with the use of laxatives (p = 0.022). 4) Physiologically, the 3-day TEA but not sham-TEA increased the percentage of normal gastric slow waves (p < 0.001) and vagal activity (p = 0.006). The vagal activity was negatively correlated with the anorexia score (r = -0.267, p = 0.026). It was found that the sympathovagal ratio and tumor size>5 cm were independent risk factors predicting the occurrence of nausea in patients after TACE.
CONCLUSION


TEA improves major TACE-induced GI disturbances in the delayed phase, including nausea, bloating, impaired gastric pace-making activity, and constipation in patients with liver cancers via the autonomic pathway.",2020,"In comparison with sham-TEA, TEA increased the number of spontaneous bowel movements (p = 0.001) and the Bristol score of the first stool (p = 0.014) and decreased the number of patients with the use of laxatives (p = 0.022).","['patients treated with TACE', 'patients who receive', 'Patients With Liver Cancers', 'Seventy-four patients with liver cancers (eighteen female; age 63.4\u2009±\u20091.1\u2009years) scheduled for', 'patients with liver cancers']","['TACE', 'Transcutaneous electrical acustimulation (TEA', 'TEA', 'chemotherapy via transcatheter arterial chemoembolization (TACE', 'sham-TEA, TEA', 'noninvasive TEA', 'Sham-TEA', 'Transcutaneous Electrical Acustimulation', 'Transcatheter Arterial Chemoembolization', 'sham-TEA']","['sympathovagal ratio and tumor size>5\u2009cm', 'percentage of normal gastric slow waves', 'nausea score on POD3', 'vagal activity', 'Symptom questionnaires', 'number of spontaneous bowel movements', 'nausea, bloating, impaired gastric pace-making activity, and constipation', 'GI symptoms', 'occurrence of nausea', 'major TACE-induced GI disturbances', 'anorexia score on POD2', 'bloating score', 'nausea on POD3', 'anorexia score', 'Gastrointestinal Disturbances', 'POD3', 'Bristol score of the first stool', 'electrogastrogram (EGG) and electrocardiogram (ECG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C4523797', 'cui_str': 'Electrogastrogram'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",74.0,0.124138,"In comparison with sham-TEA, TEA increased the number of spontaneous bowel movements (p = 0.001) and the Bristol score of the first stool (p = 0.014) and decreased the number of patients with the use of laxatives (p = 0.022).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xianpeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Disease, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Jibo', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Intervention, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Wenyi', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Division of Intervention, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Division of Gastroenterology, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Division of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Division of Infectious Disease, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Disease, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Chao', 'Affiliation': ""Division of Gastroenterology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Qingcheng', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Division of Gastroenterology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University, Baltimore, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13158']
103,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY


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


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


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


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


URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026']
104,32376818,"Dietary Melatonin Therapy Alleviates the Lamina Cribrosa Damages in Patients with Mild Cognitive Impairments: A Double-Blinded, Randomized Controlled Study.","BACKGROUND Alzheimer's disease (AD) is a degenerative disease that is characterized by massive neuron devastations in the hippocampus and cortex. Mild cognitive impairment (MCI) is the transitory stage between normality and AD dementia. This study aimed to investigate the melatonin induced effects on the lamina cribrosa thickness (LCT) of patients with MCI. MATERIAL AND METHODS The LCT data of patients with MCI were compared to LCT data of healthy controls. Subsequently, all MCI patients were randomly assigned into an experimental group (with melatonin treatment) or a placebo group (without any melatonin treatment). RESULTS The LCT of MCI patients decreased significantly compared with healthy controls. The univariate analysis showed that the lower the Mini Mental State Examination (MMSE) score (P=0.038; 95% CI: 0.876, -0.209), the smaller hippocampus volume (P=0.001; 95% CI: -1.594, -2.911), and the upregulated level of cerebrospinal fluid (CSF) T-tau (P=0.036; 95% CI: 2.546, -0.271) were associated significantly with the thinner LCT in MCI patients. There were 40 patients in the experimental group and 39 patients in the placebo group. The mean age of the experimental group was not significantly different from the placebo group (66.3±8.8 versus 66.5±8.3; P>0.05). The LCT and hippocampus volume of the melatonin treated group were significantly larger compared with the placebo group (P<0.001). On the other hand, the CSF T-tau level of the melatonin treated group was significantly lower compared with the untreated group (P<0.001). CONCLUSIONS LCT assessment might allow early diagnosis of MCI. Dietary melatonin therapy could provide an effective medication for MCI patients with LCT alterations.",2020,"The univariate analysis showed that the lower the Mini Mental State Examination (MMSE) score (P=0.038; 95% CI: 0.876, -0.209), the smaller hippocampus volume (P=0.001; 95% CI: -1.594, -2.911), and the upregulated level of cerebrospinal fluid (CSF) T-tau (P=0.036; 95% CI: 2.546, -0.271) were associated significantly with the thinner LCT in MCI patients.","['patients with MCI', 'MCI patients with LCT alterations', '40 patients in the experimental group and 39 patients in the placebo group', 'Patients with Mild Cognitive Impairments', ""Alzheimer's disease (AD""]","['melatonin', 'Dietary melatonin therapy', 'Dietary Melatonin Therapy', 'placebo']","['LCT and hippocampus volume', 'smaller hippocampus volume', 'Mini Mental State Examination (MMSE) score', 'Mild cognitive impairment (MCI', 'lamina cribrosa thickness (LCT', 'upregulated level of cerebrospinal fluid (CSF) T-tau', 'CSF T-tau level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",,0.24549,"The univariate analysis showed that the lower the Mini Mental State Examination (MMSE) score (P=0.038; 95% CI: 0.876, -0.209), the smaller hippocampus volume (P=0.001; 95% CI: -1.594, -2.911), and the upregulated level of cerebrospinal fluid (CSF) T-tau (P=0.036; 95% CI: 2.546, -0.271) were associated significantly with the thinner LCT in MCI patients.","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China (mainland).'}, {'ForeName': 'Haixiang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Surgery, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China (mainland).'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China (mainland).'}, {'ForeName': 'Bang', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Neurosurgery, Liaohe Oil Gem Flower Hospital, Panjin, Liaoning, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923232']
105,32376640,Effect of yoga as add-on therapy in migraine (CONTAIN): A randomized clinical trial.,"OBJECTIVE


To evaluate the effectiveness of yoga as an adjuvant to conventional medical management on clinical outcomes in patients with migraine.
METHODS


CONTAIN was a prospective, randomized, open-label superiority trial with blinded endpoint assessment carried out at a single tertiary care academic hospital in New Delhi, India. Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine and were randomized into medical and yoga groups (1:1). Randomization was computer-generated with a variable block size and concealed. A predesigned yoga intervention was given for 3 months. Outcomes were recorded by a blinded assessor. The primary endpoint was a decrease in headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score. Secondary outcomes included change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients.
RESULTS


Between April 2017 and August 2018, 160 patients with episodic migraine were randomly assigned to medical and yoga groups. A total of 114 patients completed the trial. Baseline measures were comparable except for a higher mean headache frequency in the yoga group. Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
CONCLUSION


Yoga as an add-on therapy in migraine is superior to medical therapy alone. It may be useful to integrate a cost-effective and safe intervention like yoga into the management of migraine.
CLINICALTRIALSGOV IDENTIFIER


CTRI/2017/03/008041.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with episodic migraine, yoga as adjuvant to medical therapy improves headache frequency, intensity, impact, and disability.",2020,"Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
","['migraine (CONTAIN', 'Between April 2017 and August 2018', '160 patients with episodic migraine', 'Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine', 'patients with episodic migraine', 'patients with migraine', 'out at a single tertiary care academic hospital in New Delhi, India', '114 patients completed the trial']",['conventional medical management'],"['headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score', 'change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients', 'headache frequency', 'headache frequency, intensity, impact, and disability', 'MIDAS score', 'pill count', 'headache intensity', 'HIT score', 'mean headache frequency']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",160.0,0.114016,"Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India. rohitbhatia71@yahoo.com.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Dhanlika', 'Initials': 'D', 'LastName': 'Dhanlika', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Singh', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dash', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'M V Padma', 'Initials': 'MVP', 'LastName': 'Srivastava', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}]",Neurology,['10.1212/WNL.0000000000009473']
106,32377777,[Surgical treatment of displaced 2-fragment fractures of the proximal humerus in older patients is not superior to nonoperative treatment-Results of a prospective randomized multicenter study].,,2020,,['older patients'],[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0180049,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mutschler', 'Affiliation': 'Klinik für Unfallchirurgie, Klinikum der Universität München, Nußbaumstraße\xa020, 80336, München, Deutschland. Wolf.mutschler@med.uni-muenchen.de.'}]",Der Unfallchirurg,['10.1007/s00113-020-00813-7']
107,32383196,Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial.,"BACKGROUND


There is no consensus regarding the most effective anaesthetic solution for children; nerve block, especially mandibular, can be difficult for general dentists. Therefore, the study aims to compare the efficacy and the adverse events of articaine 4% with epinephrine 1:100 000 with lidocaine 2% with epinephrine 1:100 000 for primary molar extraction using buccal infiltration.
METHODS


These are data from a parallel triple-blind randomised controlled trial with a computer-generated allocation treatment. Forty-three children aged 6-10 years with a clinical and radiographic indication of primary molar extraction were enrolled. The intervention was local buccal infiltration with articaine 4% compared with lidocaine 2%. The main outcome was pain during anaesthetic injection and tooth extraction. Adverse events were examined as secondary outcomes. Children were treated in a University setting from April to June 2019.
RESULTS


Both solutions had similar anaesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; P = .76); however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28-4.57; P = .02). The measured lidocaine pH was 3.19 (0.15) and articaine was 2.43 (0.00) (P = .04). Post-operative pain, oedema and nausea were observed without differences between the groups.
CONCLUSIONS


There was no difference in the efficacy of articaine compared to lidocaine for primary molar extraction. Articaine was more painful during the injection.
PRACTICAL IMPLICATIONS


Primary molar extractions can be performed with both articaine and lidocaine buccal infiltration.",2020,"Both solutions had similar anesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; p=0.76), however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28 to 4.57; p=0.02).","['primary molars extraction using buccal infiltration', 'primary molars extraction', 'Forty-three children aged 6-10 years old with a clinical and radiographic indication of primary molar extraction were enrolled', 'Children were treated in a University setting from April to June 2019']","['Articaine', 'lidocaine', 'articaine', 'articaine and lidocaine buccal infiltration', 'epinephrine']","['anesthetic efficacy', 'pain during anesthetic injection and tooth extraction', 'Adverse events', 'mean pain', 'lidocaine pH', 'Postoperative pain, edema, and nausea', 'Efficacy and adverse events', 'local buccal infiltration']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",43.0,0.201014,"Both solutions had similar anesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; p=0.76), however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28 to 4.57; p=0.02).","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Massignan', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Silveira Santos', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}]",Journal of oral rehabilitation,['10.1111/joor.12989']
108,32383352,Phase I Single-Blinded Randomized Controlled Trial Comparing Balance and Aerobic Training in Degenerative Cerebellar Disease.,"INTRODUCTION


Primary deficits in individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination. Balance training is routinely recommended to improve function whereas little is known regarding aerobic training.
OBJECTIVE


To determine the feasibility of conducting a randomized trial comparing balance and aerobic training in individuals with cerebellar degeneration.
DESIGN


Assessor blinded randomized control phase I trial.
SETTING


Assessments in medical center, home training.
PARTICIPANTS


Twenty participants with cerebellar degeneration were randomized to home balance or aerobic training.
INTERVENTION


Aerobic training consisted of 4 weeks of stationary bicycle training, five times per week for 30-minute sessions. Home balance training consisted of performing the same duration of easy, moderate, and/or hard exercises.
OUTCOME MEASURES


Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO 2  max), Dynamic Gait Index, Timed Up and Go, gait speed.
RESULTS


All 20 participants completed assigned training with no major adverse events. Seven of each group attained target training duration, frequency, and intensity. Although both groups had significant improvements in ataxia severity, balance, and gait measures, there were greater improvements in individuals who performed aerobic training in ataxia severity and maximal oxygen consumption when compared to balance training. The effect size for these outcome measures was determined to be large, indicating a phase II trial comparing the benefits of aerobic and balance training was feasible and required 26 participants per group. Improvements in SARA score and VO 2  max remained in the aerobic training group at 3 months posttraining, but these improvements were trending back to baseline. In contrast, all balance group measures for pretraining and 3 months posttraining were statistically similar.
CONCLUSIONS


A phase II trial comparing balance and aerobic training in individuals with cerebellar degeneration is feasible. Benefits trended back toward baseline after training stopped, although benefits of longer duration exercise programs still need to be determined.",2020,"Improvements in SARA score and VO 2  max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","['Assessments in medical center, home-training', 'individuals with cerebellar degeneration', 'individuals with cerebellar degeneration is feasible', 'individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination', '20 participants with cerebellar degeneration', 'Degenerative Cerebellar Disease']","['Aerobic training consisted of four-weeks of stationary bicycle training', 'aerobic and balance training', 'Balance training', 'aerobic training', 'home balance or aerobic training', 'Balance and Aerobic Training', 'balance and aerobic training']","['SARA score and VO 2  max', 'Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO2max), Dynamic Gait Index (DGI), Timed up and Go (TUG), gait speed', 'ataxia severity and maximal oxygen consumption', 'ataxia severity, balance, and gait measures']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262404', 'cui_str': 'Cerebellar degeneration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0231686', 'cui_str': 'Unsteady gait'}, {'cui': 'C0520966', 'cui_str': 'Incoordination'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0007760', 'cui_str': 'Cerebellar disorder'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0295574,"Improvements in SARA score and VO 2  max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barbuto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Martelli', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Omofuma', 'Initials': 'O', 'LastName': 'Isirame', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12401']
109,32379496,Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes.,"Background:  We evaluated the feasibility and acceptability of a pilot behavioral intervention delivered to parents of adolescents with type 1 diabetes (T1D) via mobile-friendly web app. The Type 1 Doing Well app aimed to promote supportive family diabetes management by helping parents recognize and reinforce teens' positive diabetes-related behaviors (""strengths"").  Methods:  Parents ( n  = 80, 74% recruitment) of adolescents (age range = 12-17 years, M = 15.3 ± 1.5 years, 59% female, 56% insulin pump, M hemoglobin A1c (HbA1c) = 9.0% ± 2.1%) were randomized 2:1 to intervention or control (i.e., usual medical care with or without app) for 3-4 months between diabetes appointments. The app prompted parents daily to track adolescents' strengths and generated weekly summaries of their teen's top strengths. Parents could access a library of text messages to praise their teens. Exploratory pre/post data included questionnaires (98% completed) and HbA1c.  Results:  Parents used the app for M = 106.1 ± 37.1 days, logging in ≥once/day on 80% of days. Ninety-one percent of parents used the app ≥2 days/week on average. Parents viewed M = 5.6 ± 4.7 weekly summaries and ""favorited"" 15 praise texts in the library. App acceptability ratings (7-point scale) were high: Satisfaction 5.0 ± 1.5, Usefulness 4.8 ± 1.5, Ease of Use 6.2 ± 0.8, and Ease of Learning 6.5 ± 0.8. Parents ( n  = 48) and adolescents ( n  = 47) gave positive feedback and suggestions via qualitative interviews. There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires).  Conclusions:  Type 1 Doing Well was feasible to deliver and highly acceptable and engaging for parents of adolescents with T1D. It may have a larger impact on behavioral or clinical outcomes as part of a multicomponent intervention protocol. Trial Registration: ClinicalTrials.gov NCT02877680.",2020,"There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires).
","['Parents of Adolescents with Type 1 Diabetes', 'parents of adolescents with type 1 diabetes (T1D) via mobile-friendly web app', 'Parents (n=80, 74% recruitment) of adolescents (age range=12-17 years, M=15.3±1.5 years, 59% female, 56% insulin pump, M HbA1c=9.0±2.1', 'parents of adolescents with T1D', 'Parents (n=48) and adolescents (n=47) gave positive feedback and suggestions via qualitative interviews']","['pilot behavioral intervention', 'Strengths-Based mHealth App', 'intervention or control (i.e., usual medical care with or without app']","['App acceptability ratings (7-point scale', 'exploratory outcomes (HbA1c, questionnaires']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0547326,"There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires).
","[{'ForeName': 'Marisa E', 'Initials': 'ME', 'LastName': 'Hilliard', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Viena T', 'Initials': 'VT', 'LastName': 'Cao', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Sahar S', 'Initials': 'SS', 'LastName': 'Eshtehardi', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Saber', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Lefkothea P', 'Initials': 'LP', 'LastName': 'Karaviti', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0048']
110,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND


Childhood maltreatment (CM) predicted poorer outcomes in acute depression treatment with CBT, IPT and Supportive Psychotherapy (SP). The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) fared well in patients with chronic depression and CM during acute treatment, yet there is a considerable lack of empirical evidence for long-term outcomes.
METHODS


We analyzed one and two-year follow-up data of 268 patients randomized to 24 sessions (20 weeks) of acute and 8 sessions (28 weeks) of extended treatment with CBASP or SP. Primary outcome was the number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE). Secondary outcomes included self- and clinician-rated depression symptoms. We investigated this moderating effect for any CM and for specific subtypes of CM.
RESULTS


Intent-to-treat analyses revealed that the presence of CM did not significantly moderate long-term effects of CBASP compared to SP. The analysis of trauma subtypes revealed that patients with childhood emotional abuse had statistically significant worse outcomes than patients without (main effect, p=.015) and that the advantage of CBASP over SP was larger in patients with childhood emotional abuse than in patients without (interaction effect, p=.045) after 1 year. No significant effects were found for other trauma subtypes.
LIMITATIONS


The measurement of CM was limited to retrospective self-assessment.
CONCLUSIONS


The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
111,32380001,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30368-6']
112,32380119,Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product.,"BACKGROUND


""Heat-not-burn"" tobacco products are designed to heat processed tobacco instead of combusting it, thus significantly reducing the formation of harmful and potentially harmful constituents (HPHCs) found in cigarette smoke, and ultimately reducing the risk of smoking-related diseases. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product similar in appearance and use ritual to cigarettes, has been developed for smokers who would otherwise continue smoking as an alternative to cigarettes. To evaluate reduced risk of harm potential of CHTP, it is critical to quantify exposure to HPHCs and consequent biological pathway disturbances involved in disease onset in smokers who switch to CHTP.
METHODS


In this 2-arm, parallel-group study, adult healthy smokers, not willing to quit, were randomized to switch to CHTP 1.2 (n = 80) or to continue using cigarettes (n = 40) for 5 days in confinement followed by 85 days in an ambulatory setting. Endpoints included biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety.
RESULTS


In switchers to CHTP, BoExp were 40%-95% lower compared to smokers after 5 days of product use, with sustained reductions (36%-93%) observed on Day 90. Urine mutagenicity and CYP1A2 activity were also lower in the CHTP group. Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day 90. Favorable changes in some biomarkers of effect were observed in the CHTP group showing reductions in white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2, respectively, indicative of reduced inflammation, endothelial dysfunction, and platelet activation.
CONCLUSIONS


Switching from cigarettes to CHTP resulted in significantly reduced exposure to HPHCs and was associated with observed improvements in some biomarkers of effect representative of pathomechanistic pathways underlying the development of smoking-related diseases.",2020,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","['smokers who switch to CHTP', 'adult healthy smokers, not willing to quit']","['CHTP', 'Carbon-Heated Tobacco Product (CHTP']","['white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2 respectively indicative of reduced inflammation, endothelial dysfunction, and platelet activation', 'biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety', 'Urine mutagenicity and CYP1A2 activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",,0.0196296,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland. Electronic address: Marija.Bosilkovska@contracted.pmi.com.'}, {'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Taranu', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Benzimra', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}]",Toxicology letters,['10.1016/j.toxlet.2020.04.013']
113,32380428,Indirect treatment comparison of nivolumab versus placebo for the adjuvant treatment of melanoma.,"INTRODUCTION


Until recently, adjuvant treatment options for stage III and IV resectable melanoma have been limited. Patients were often managed through routine surveillance. The phase III randomised controlled trial (RCT) CheckMate 238 (238) demonstrated the safety and efficacy of nivolumab as an adjuvant treatment for melanoma in patients with stage IIIB/C or IV disease (American Joint Committee on Cancer [AJCC], 7th edition) versus ipilimumab. The study objective was to estimate the relative efficacy, safety and health-related quality of life (HRQoL) between nivolumab and routine surveillance.
METHODS


Indirect treatment comparisons (ITCs) of nivolumab versus placebo were constructed using data from 238 and EORTC 18071. EORTC 18071 is a phase III RCT comparing ipilimumab with placebo in patients with resected stage IIIA-IIIC melanoma (AJCC, 6th edition). ITCs were performed using the Bucher comparison method and patient-level data for efficacy, safety and HRQoL.
RESULTS


For the efficacy outcomes, nivolumab performed significantly better than placebo for recurrence-free survival (hazard ratio [HR]: 0.53 [95% confidence interval {CI}: 0.41, 0.68]) and distant metastases-free survival (HR: 0.59 [95% CI: 0.44, 0.78]). Safety ITCs indicated that patients receiving nivolumab had a greater hazard of experiencing an adverse event (AE) and AEs leading to treatment discontinuation, whereas there was a non-significant increased hazard of experiencing a serious AE. HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
CONCLUSION


Nivolumab was associated with significantly improved efficacy outcomes versus placebo, whereas maintaining patient's overall HRQoL. Across the different analysis and populations, there was a high level of consistency in the effect size.",2020,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","['patients with resected stage IIIA-IIIC melanoma (AJCC, 6th edition', 'patients with stage IIIB/C or IV disease (American Joint Committee on Cancer [AJCC], 7th edition) versus', 'melanoma']","['nivolumab versus placebo', 'nivolumab', 'ipilimumab with placebo', 'ipilimumab', 'placebo']","['relative efficacy, safety and health-related quality of life (HRQoL', 'hazard of experiencing a serious AE', 'distant metastases-free survival', 'hazard of experiencing an adverse event (AE) and AEs leading to treatment discontinuation', 'safety and efficacy', 'recurrence-free survival (hazard ratio [HR', 'efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.626136,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hemstock', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK. Electronic address: mhemstock@bresmed.com.'}, {'ForeName': 'Adenike', 'Initials': 'A', 'LastName': 'Amadi', 'Affiliation': 'Bristol-Myers Squibb, Uxbridge, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kupas', 'Affiliation': 'Bristol-Myers Squibb GmbH & Co. KGaA, Munich, Germany.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Roskell', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Kotapati', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Kyna', 'Initials': 'K', 'LastName': 'Gooden', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'University of Oxford, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen and German Cancer Consortium, Heidelberg, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.011']
114,32380445,Intermittent theta-burst stimulation moderates interaction between increment of N-Acetyl-Aspartate in anterior cingulate and improvement of unipolar depression.,"BACKGROUND


Intermittent theta-burst stimulation (iTBS), a novel repetitive transcranial magnetic stimulation (rTMS) technique, appears to have antidepressant effects when applied over left dorsolateral prefrontal cortex (DLPFC). However, its underlying neurobiological mechanisms are unclear. Proton magnetic resonance spectroscopy ( 1 H-MRS) provides in vivo measurements of cerebral metabolites altered in major depressive disorder (MDD) like N-acetyl-aspartate (NAA) and choline-containing compounds (Cho). We used MRS to analyse effects of iTBS on the associations between the shifts in the NAA and Cho levels during therapy and MDD improvement.
METHODS


In-patients with unipolar MDD (N = 57), in addition to treatment as usual, were randomized to receive 20 iTBS or sham stimulations applied over left DLPFC over four weeks. Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up. Increments of concentrations, as well as MDD improvement, were defined as endpoints. We tested a moderated mediation model of effects using the PROCESS macro (an observed variable ordinary least squares and logistic regression path analysis modeling tool) for SPSS.
RESULTS


Improvement of depressive symptoms was significantly associated with decrease of Cho/NAA ratio, mediated by NAA. iTBS had a significant moderating effect enhancing the relationship between NAA change and depression improvement.
CONCLUSIONS


Our findings suggest a potential neurochemical pathway and mechanisms of antidepressant action of iTBS, which may moderate the improvement of metabolic markers of neuronal viability. iTBS might increase neuroplasticity, thus facilitating normalization of neuronal circuit function.",2020,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,[],"['Intermittent theta-burst stimulation (iTBS', '20 iTBS or sham stimulations applied over left DLPFC', 'repetitive transcranial magnetic stimulation (rTMS) technique', 'Proton magnetic resonance spectroscopy ( 1 H-MRS']","['Cho/NAA ratio', 'NAA change and depression improvement', 'depressive symptoms', 'unipolar depression']",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.0453926,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Zavorotnyy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Department of Psychiatry and Psychotherapy, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Brugg, Switzerland; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany. Electronic address: maxim.zavorotnyy@staff.uni-marburg.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zöllner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Health Protection Authority, Frankfurt, Main, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Rekate', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dietsche', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bopp', 'Affiliation': 'Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany; Department of Neurosurgery, University of Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Krug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nenadić', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.03.015']
115,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
116,32380260,Methodological and reporting issues in a randomised controlled trial: Comment on de la Fuente et al (2020).,,2020,,[],[],[],[],[],[],,0.0693986,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast BT9 7BL, United Kingdom. Electronic address: p.ohalloran@qub.ac.uk.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103585']
117,32380427,Differences in disease status between patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer: Exploratory analysis of the randomized phase III TRICS trial.,"BACKGROUND


Second-line chemotherapy (SLC) improves survival in advanced gastric cancer (AGC). Patients receiving SLC are categorized into two disease status groups: tumour progression after first-line chemotherapy and early recurrence after adjuvant chemotherapy. Differences between these groups have not yet been clarified.
PATIENTS AND METHODS


A total of 163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n = 55) or the early relapse (ER) group (n = 108). We compared overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety. Adjusted OS and adjusted PFS were estimated using inverse probability of treatment weighting (IPTW).
RESULTS


The ER group had a lower median age than the PD group (66 vs. 72 years; P = 0.016), performance status (PS) 0 was more frequently seen in the ER group (87% vs. 71%; P = 0.012). The adjusted median OS was 13.7 months in the ER group and 13.6 months in the PD group (IPTW hazard ratio [HR]: 1.023; P = 0.854). The adjusted median PFS was 4.9 months in the ER group and 4.4 months in the PD group (IPTW HR: 0.707; P = 0.004). ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020). No significant differences were observed in the incidence of adverse events.
CONCLUSIONS


ER was associated with improved PFS and better ORR than PD, although no difference in survival was demonstrated. From the viewpoint of treatment outcome, it seems appropriate to treat patients with ER in the same way as patients with PD.
CLINICAL TRIAL REGISTRATION


UMIN 000002571.",2020,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"['advanced gastric cancer (AGC', 'patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer', '163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n\xa0=\xa055) or the early relapse (ER) group (n\xa0=\xa0108']",['Second-line chemotherapy (SLC'],"['adjusted median PFS', 'survival', 'ORR', 'performance status (PS) 0', 'adjusted median OS', 'incidence of adverse events', 'PFS and better ORR', 'overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",163.0,0.100949,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: kazuno13@hotmail.co.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Graduate School of Medicine, Kurume University, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. Electronic address: kmurotani@med.kurume-u.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056 Japan. Electronic address: fujitani@gh.opho.jp.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Inagaki', 'Affiliation': 'Department of Surgery, Inagaki Clinic, 1-2-9, Nenohanacho, Owariasahi, 488-0002 Japan. Electronic address: h.inagaki@ina-cl.com.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, 563-8510 Japan. Electronic address: akamaru@ka3.so-net.ne.jp.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 Japan. Electronic address: t-shinya@d7.dion.ne.jp.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Surgery, Shizuoka General Hospital, 4-27-1, Kitaando, Aoi-ku, Shizuoka, 420-0881 Japan. Electronic address: masakazu-takagi@i.shizuoka-pho.jp.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryugecho, Yao, 581-0069 Japan. Electronic address: shigeyuki.tamura@hosp-yao.osaka.jp.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567 Japan. Electronic address: sugimoto-na2@mc.pref.osaka.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Gastroenterology, Saiseikai Shiga Prefectural Hospital, 2-4-1, Ohashi Ritto, 520-3046 Japan. Electronic address: bssjh242@yahoo.co.jp.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, The National Hospital Organization National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan. Electronic address: tayoshik@ncc.go.jp.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center,1981, Kamoda, Kawagoe, 350-0844 Japan. Electronic address: itoru@saitama-med.ac.jp.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Comprehensive Cancer Center, Aizawa Hospital, 2-5-1, Honjo, Matsumoto, 390-0814 Japan. Electronic address: geka-dr7@ai-hosp.or.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: hasegawa.hiroko.yr@mail.hosp.go.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8397 Japan. Electronic address: smorita@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Miyashita', 'Affiliation': 'Data Center, Epidemiological & Clinical Research Information Network, 21-7, Shogoinsannocho, Sakyo-ku, Kyoto, 606-8392 Japan. Electronic address: miya@ecrin.or.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': 'Department of Surgery, Ozawa Hospital, 1-1-17, Honcho, Odawara, 250-0012 Japan. Electronic address: tuburayaa@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, 4-6-2, Sohara Higashijimacho, Kakamigahara, 504-8601 Japan. Electronic address: sakamjun@tokaihp.jp.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Kaizuka City Hospital, 3-10-20, Hori, Kaizuka, 597-0015 Japan. Electronic address: tsujinaka@hosp.kaizuka.osaka.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.027']
118,32383767,"Effect of oral consumption of capsules containing Lactobacillus paracasei LPC-S01 on the vaginal microbiota of healthy adult women: a randomized, placebo-controlled, double-blind crossover study.","Oral consumption of probiotics is practical and can be an effective solution to preserve vaginal eubiosis. Here, we studied the ability of orally administered Lactobacillus paracasei LPC-S01 (DSM 26760) to affect the composition of the vaginal microbiota and colonize the vaginal mucosa in nondiseased adult women. A total of 40 volunteers took oral probiotic (24 billion CFU) or placebo capsules daily for 4 weeks, and after a 4-week washout, they switched to placebo or probiotic capsules according to the crossover design. A total of 23 volunteers completed the study according to the protocol. Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing. Vaginal swabs were grouped according to their bacterial taxonomic structure into nine community state types (CSTs), four of which were dominated by lactobacilli. Lactobacillus paracasei LPC-S01 was detected in the vagina of two participants. Statistical modeling (including linear mixed-effects model analysis) demonstrated that daily intake of probiotic capsules reduced the relative abundance of Gardnerella spp. Quantitative PCR with Gardnerella vaginalis primers confirmed this result. Considering the pathogenic nature of G. vaginalis, these results suggest a potential positive effect of this probiotic capsule on the vaginal microbial ecosystem.",2020,"Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing.","['healthy adult women', 'Twenty-three volunteers completed the study according to the protocol', 'nondiseased adult women', 'Forty volunteers took']","['oral probiotic (24 billion CFU) or placebo', 'Lactobacillus paracasei LPC-S01 (DSM26760', 'oral consumption of capsules containing Lactobacillus paracasei LPC-S01', 'placebo']","['relative abundance of Gardnerella spp', 'L. paracasei LPC-S01', 'vaginal microbiota']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",40.0,0.149525,"Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing.","[{'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Koirala', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Arioli', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Taverniti', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiore', 'Affiliation': 'Sofar S.p.A., Via Firenze 40, 20060, Trezzano Rosa (MI), Trezzano Rosa, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grossi', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Gaia Maria', 'Initials': 'GM', 'LastName': 'Anelli', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}]",FEMS microbiology ecology,['10.1093/femsec/fiaa084']
119,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
120,32380449,Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial.,"BACKGROUND


The contralesional hemisphere compensation may play a critical role in the recovery of stroke when there is extensive damage to one hemisphere. There is little research on the treatment of hemiplegia by high-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the contralesional cortex.
OBJECTIVE


We conducted a 2-week randomized, sham-controlled, single-blind trial to determine whether high-frequency rTMS (HF-rTMS) over the contralesional motor cortex can improve motor function in severe stroke patients.
METHODS


Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory were randomly assigned to treatment with 10 Hz rTMS (HF group), 1 Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks. The primary outcome was the change in the Fugl-Meyer Motor Assessment (FMA) Scale score from baseline to 2 weeks. The secondary endpoints included root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability.
RESULTS


The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group. There were no significant differences between the LF group and sham group. There was a positive correlation between cortical conductivity of the uninjured hemisphere and recovery of motor impairment (p = 0.039).
CONCLUSIONS


HF-rTMS over the contralesional cortex was superior to low-frequency rTMS and sham stimulation in promoting motor recovery in patients with severe hemiplegic stroke by acting on contralesional cortex plasticity.
TRIAL REGISTRATION


Clinical trial registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn/showproj.aspx?proj=23264 (ChiCTR-IPR-17013580).",2020,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","['severe hemiplegic stroke', 'Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory', 'patients with severe hemiplegic stroke', 'severe stroke patients']","['high-frequency repetitive transcranial magnetic stimulation', 'HF-rTMS', 'high-frequency rTMS (HF-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\xa0Hz rTMS (HF group), 1\xa0Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks']","['FMA score', 'root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability', 'change in the Fugl-Meyer Motor Assessment (FMA) Scale score', 'cortical conductivity of the uninjured hemisphere and recovery of motor impairment', 'contralesional hemisphere cortical excitability and conductivity', 'RMS-SEMG of the key muscles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",45.0,0.537609,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue-Wen', 'Initials': 'YW', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China. Electronic address: mayw@cmu1h.com.'}]",Brain stimulation,['10.1016/j.brs.2020.03.020']
121,32384055,"Usability, Acceptability, and Effectiveness of Web-Based Conversational Agents to Facilitate Problem Solving in Older Adults: Controlled Study.","BACKGROUND


The usability and effectiveness of conversational agents (chatbots) that deliver psychological therapies is under-researched.
OBJECTIVE


This study aimed to compare the system usability, acceptability, and effectiveness in older adults of 2 Web-based conversational agents that differ in theoretical orientation and approach.
METHODS


In a randomized study, 112 older adults were allocated to 1 of the following 2 fully automated interventions: Manage Your Life Online (MYLO; ie, a chatbot that mimics a therapist using a method of levels approach) and ELIZA (a chatbot that mimics a therapist using a humanistic counseling approach). The primary outcome was problem distress and resolution, with secondary outcome measures of system usability and clinical outcome.
RESULTS


MYLO participants spent significantly longer interacting with the conversational agent. Posthoc tests indicated that MYLO participants had significantly lower problem distress at follow-up. There were no differences between MYLO and ELIZA in terms of problem resolution. MYLO was rated as significantly more helpful and likely to be used again. System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse. Adherence was high. A total of 12% (7/59) of the MYLO group did not carry out their conversation with the chatbot.
CONCLUSIONS


Controlled studies of chatbots need to be conducted in clinical populations across different age groups. The potential integration of chatbots into psychological care in routine services is discussed.",2020,System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse.,"['112 older adults', 'Older Adults', 'older adults']","['Web-Based Conversational Agents', 'ELIZA', 'conversational agents (chatbots']","['problem distress', 'Usability, Acceptability, and Effectiveness', 'system usability, acceptability, and effectiveness', 'Manage Your Life Online (MYLO', 'problem distress and resolution, with secondary outcome measures of system usability and clinical outcome']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",112.0,0.098404,System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse.,"[{'ForeName': 'Matthew Russell', 'Initials': 'MR', 'LastName': 'Bennion', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Hardy', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Roger K', 'Initials': 'RK', 'LastName': 'Moore', 'Affiliation': 'Department of Computer Science, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Millings', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16794']
122,32323890,Higher plasma asparaginase activity after intramuscular than intravenous Erwinia asparaginase.,"It is unclear if dosing intervals for Erwinase can be extended with intramuscular (i.m.) versus intravenous (i.v.) dosing. Children with acute lymphoblastic leukemia received Erwinase at 30 000-42 000 IU/m 2  i.v. or i.m. I.m. Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v. Erwinase (n = 33) (3.4 vs 2.9 days, P = 0.0007). With 30 000 IU/m 2  Monday, Wednesday, Friday, more patients achieved adequate concentrations over the weekend with i.m. vs i.v. dosing (P = 5 × 10 -36  ). A schedule with i.v. doses on Monday and Wednesday and i.m. doses on Friday of 30 000 IU/m 2  maintained activity > 0.1 IU/mL over the weekend in 80% of patients.",2020,Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v.,"['Children with acute lymphoblastic leukemia', 'Erwinase (n\xa0=\xa033) ']",[],"['activity', 'Higher plasma asparaginase activity', 'adequate concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0591457', 'cui_str': 'Erwinase'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0241334,Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v.,"[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Panetta', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Hope D', 'Initials': 'HD', 'LastName': 'Swanson', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Seth E', 'Initials': 'SE', 'LastName': 'Karol', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}]",Pediatric blood & cancer,['10.1002/pbc.28244']
123,32386082,Long-term mortality in the Intermediate care after emergency abdominal surgery (InCare) trial-A post-hoc follow-up study.,"BACKGROUND


Patients undergoing emergency abdominal surgery are at high risk of post-operative complications. Although post-operative treatment at an intermediate care unit may improve early outcome, there is a lack of studies on the long-term effects of such therapy. The aim of this study was to assess the long-term effect of intermediate care versus standard surgical ward care on mortality in the Intermediate Care After Emergency Abdominal Surgery (InCare) trial.
METHODS


We included adult patients undergoing emergency major laparoscopy or laparotomy with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 10 or more, who participated in the InCare trial from October 2010 to November 2012. In the InCare trial, patients were randomized to either post-operative intermediate care or standard surgical ward care. The primary outcome was time to death within 6 years after surgery. We assessed mortality with Coxregression analysis.
RESULTS


A total of 286 patients were included. The all-cause 6-year landmark mortality was 52.8% (76 of 144 patients) in the intermediate care group and 47.9% (68 of 142 patients) in the ward care group. There was no statistically significant difference in mortality risk between the two groups (hazard ratio 1.06 (95% confidence interval 0.76-1.47), P = .73).
CONCLUSION


We found no statistically significant difference in 6-year mortality between patients randomized to post-operative intermediate care or ward care after emergency abdominal surgery. However, we detected an absolute mortality risk reduction of 5% in favour of ward care, possibly due to random error.",2020,We found no statistically significant difference in six-year mortality between patients randomised to postoperative intermediate care or ward care afteremergency abdominal surgery.,"['A total of 286 patients were included', 'Patients undergoing emergency abdominal surgeryare at high risk of postoperative complications', 'After Emergency Abdominal Surgery (InCare) trial', 'adult patients undergoingemergency major laparoscopy or laparotomy with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 10 or more, who participated in the InCare trial from October 2010 to November 2012']","['postoperative intermediate care or standard surgical ward care', 'intermediate care versus standard surgical ward care']","['six-year mortality', 'cause six-year landmark mortality', 'mortality risk', 'time to death within six years after surgery']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",286.0,0.118646,We found no statistically significant difference in six-year mortality between patients randomised to postoperative intermediate care or ward care afteremergency abdominal surgery.,"[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Hansted', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care 4131, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Møller', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit Dpt. 7812, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Waldau', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Vester-Andersen', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13613']
124,32385943,Prospective and randomized comparative study of calcium hydroxylapatite vs calcium hydroxylapatite plus HIFU in treatment of moderate-to-severe acne scars.,"BACKGROUND


Acne scars are the most common sequelae of the severe inflammatory process of acne, and its managing is a challenge. Objective of this study was to assess safety and effectiveness of calcium hydroxylapatite monotherapy and its association with high-intensity microfocused ultrasound for treating moderate-to-severe atrophic acne scars.
METHODS


Women with moderate-to-severe atrophic scars of the face were enrolled on the study. Assessments were made by digital macrophotographs, Vectra H2, and Antera 3D.
RESULTS


From October to December 2019, twenty women which fitted the inclusion criteria signed a consent form and received 3.0 mL of calcium hydroxylapatite and after 4 weeks, 400 lines of HIFU. No major side effects were reported during the study, and all patients completed the follow-up after 6 months. At 1 month, patients treated with calcium hydroxylapatite (group 1) improved wrinkles and skin texture compared to placebo (group 2). At 3 and 6 months, all patients improved acne scars.
CONCLUSION


Our study showed that that both calcium hydroxylapatite and HIFU in monotherapy were safe and effective treatments for atrophic scar acne. Calcium hydroxylapatite was clinically effective when compared with placebo, though the combination of calcium hydroxylapatite and HIFU did not enhance the clinical efficacy compared to monotherapy.",2020,"At 1 month, patients treated with calcium hydroxylapatite (group 1) improved wrinkles and skin texture compared to placebo (group 2).","['Women with moderate to severe atrophic scars of the face were enrolled on the study', 'moderate to severe acne scars']","['calcium hydroxylapatite and HIFU', 'calcium hydroxylapatite versus calcium hydroxylapatite plus Hifu', 'calcium hydroxylapatite monotherapy', 'calcium hydroxylapatite', 'placebo']","['clinical efficacy', 'wrinkles and skin texture', 'acne scars', 'atrophic scar acne']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]",20.0,0.0247277,"At 1 month, patients treated with calcium hydroxylapatite (group 1) improved wrinkles and skin texture compared to placebo (group 2).","[{'ForeName': 'Araco', 'Initials': 'A', 'LastName': 'Antonino', 'Affiliation': 'Aesthetic Medicine Department, Cosmetic Surgeon at Univeristy Tor Vergata of Roma, Rome, Italy.'}, {'ForeName': 'Araco', 'Initials': 'A', 'LastName': 'Francesco', 'Affiliation': 'Private Practice in Rome, Rome, Italy.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13472']
125,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
126,32385158,Common and dissociable effects of oxytocin and lorazepam on the neurocircuitry of fear.,"Benzodiazepines (BZDs) represent the gold standard of anxiolytic pharmacotherapy; however, their clinical benefit is limited by side effects and addictive potential. Consequently, there is an urgent need to develop novel and safe anxiolytics. The peptide hormone oxytocin (OXT) exhibits anxiolytic-like properties in animals and humans, but whether OXT and BZDs share similar effects on the neural circuitry of fear is unclear. Therefore, the rationale of this ultra-high-field functional MRI (fMRI) study was to test OXT against the clinical comparator lorazepam (LZP) with regard to their neuromodulatory effects on local and network responses to fear-related stimuli. One hundred twenty-eight healthy male participants volunteered in this randomized double-blind, placebo-controlled, between-group study. Before scanning using an emotional face-matching paradigm, participants were randomly administered a single dose of OXT (24 IU), LZP (1 mg), or placebo. On the behavioral level, LZP, but not OXT, caused mild sedation, as evidenced by a 19% increase in reaction times. On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA). In contrast, they had different effects on intra-amygdalar connectivity; OXT strengthened the coupling between the cmA and basolateral amygdala, whereas LZP increased the interplay between the cmA and superficial amygdala. Furthermore, OXT, but not LZP, enhanced the coupling between the cmA and the precuneus and dorsomedial prefrontal cortex. These data implicate inhibition of the cmA as a common denominator of anxiolytic action, with only OXT inducing large-scale connectivity changes of potential therapeutic relevance.",2020,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).",['One hundred twenty-eight healthy male participants volunteered'],"['Benzodiazepines (BZDs', 'oxytocin and lorazepam', 'OXT', 'LZP', 'peptide hormone oxytocin (OXT', 'lorazepam (LZP', 'placebo']","['neurocircuitry of fear', 'reaction times']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",128.0,0.100533,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, 35390 Giessen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, 26129 Oldenburg, Germany.'}, {'ForeName': 'Torge', 'Initials': 'T', 'LastName': 'Dellert', 'Affiliation': 'Institute of Medical Psychology and Systems Neuroscience, University of Muenster, 48149 Muenster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Babasiz', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Herscheid', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Remmersmann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Stirnberg', 'Affiliation': 'Division of MR Physics, German Center for Neurodegenerative Diseases, 53175 Bonn, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stöcker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany; renehurlemann@icloud.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920147117']
127,32391919,Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.,"BACKGROUND


Fungal infections are a major complication of neutropaenia following chemotherapy. Their early diagnosis is difficult, and empirical antifungal treatment is widely used, and uses of less toxic drugs that reduce breakthrough infection are required.
OBJECTIVE


We conducted a multicentre, open-label, randomised, non-inferiority trial to compare the safety and efficacy of intravenous itraconazole (ivITCZ) and liposomal amphotericin B (LAmB) as empirical antifungal therapy in patients with haematological malignancies with neutropaenia and persistent fever.
METHODS


Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled. Patients were randomised for treatment with LAmB (3.0 mg/kg/d) or ivITCZ (induction: 400 mg/d, maintenance: 200 mg/d).
RESULTS


Observed overall favourable response rates of 17/52 (32.7%) and 18/50 (36.0%) in the LAmB and ivITCZ groups, with a model-based estimate of a 4% difference (90% CI, -12% to 20%), did not fulfil the statistical non-inferiority criterion. In the LAmB group, there were two cases of breakthrough infection and five cases of probable invasive fungal disease, whereas in the itraconazole group, neither breakthrough infection nor probable invasive fungal disease occurred. Patients in the ivITCZ group had significantly fewer grade 3-4 hypokalaemia-related events than LAmB group patients (P < .01). The overall incidence of adverse events tended to be lower in the ivITCZ group (P = .07).
CONCLUSION


ivITCZ showed similar efficacy and safety as LAmB as empirical antifungal therapy in haematological malignancy patients with febrile neutropaenia, although the small sample size and various limitations prevented demonstration of its non-inferiority.",2020,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07).
","['patients with neutropaenia and persistent fever', 'haematological malignancy patients with febrile neutropaenia', 'Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled', 'patients with haematological malignancies with neutropaenia and persistent fever']","['itraconazole', 'itraconazole (ivITCZ) and liposomal amphotericin B (LAmB', 'Intravenous itraconazole', 'ivITCZ', 'LAmB', 'liposomal amphotericin B']","['breakthrough infection nor probable invasive fungal disease', 'overall incidence of adverse events', 'grade 3-4 hypokalaemia-related events', 'efficacy and safety', 'safety and efficacy', 'overall favourable response rates', 'breakthrough infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476474', 'cui_str': 'Persistent fever'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}]","[{'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.107165,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07).
","[{'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akiko M', 'Initials': 'AM', 'LastName': 'Saito', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Ilseung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hidaka', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Kagoo', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroatsu', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Niimi', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Komeno', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Chikamasa', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Tajima', 'Affiliation': 'Stem Cell Transplantation Center, National Hospital Organization Yonago Medical Center, Yonago, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Shimomura', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Kubonishi', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Sakurai', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Department of Bacteriology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",Mycoses,['10.1111/myc.13100']
128,32386593,"Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial.","BACKGROUND


Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response.
METHODS


This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080.
FINDINGS


Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator.
INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis.
FUNDING


Novartis Pharma.",2020,"INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","['26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis', 'Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive', '709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50', 'patients with psoriatic arthritis', '61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101', 'Eligible patients', 'patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response']","['adalimumab', 'interactive response technology to receive secukinumab or adalimumab', 'secukinumab (n=426) or adalimumab', 'secukinumab and adalimumab', 'Secukinumab versus adalimumab', 'Adalimumab', 'secukinumab', 'secukinumab versus adalimumab', 'mL citrate free subcutaneous injection']","['superiority of secukinumab versus adalimumab for ACR20 response', 'proportion of patients with at least 20% improvement in the ACR response criteria (ACR20', 'efficacy and safety', 'serious infections', 'ACR20 response']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",853.0,0.314879,"INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. Electronic address: iain.mcinnes@glasgow.ac.uk.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'Rheumatology University Hospital and Fraunhofer Institute for Molecular Biology and Applied Ecology, Branch for Translational Medicine and Pharmacology and Fraunhofer Cluster of Excellence for Immune-Mediated Diseases, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Centre, Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'Rheumatology, Allergy, Immunology Division, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ritchlin', 'Affiliation': 'Allergy, Immunology and Rheumatology Division, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Jordi Gratacós', 'Initials': 'JG', 'LastName': 'Masmitja', 'Affiliation': 'Rheumatology Department, University Hospital Parc Taulí, Sabadell, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology and INSERM-CIC1415, University Hospital of Tours, EA 7501 GICC, University of Tours, Tours, France.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Korotaeva', 'Affiliation': 'Research Institute of Rheumatology n.a. V A Nasonova, Moscow, Russia.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ruvie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pellet', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30564-X']
129,32388857,"Assisted breastfeeding technique to improve knowledge, attitude, and practices of mothers with cleft lip- and palate-affected infants: A randomized trial.","BACKGROUND


Cleft lip and palate is one of the most common developmental anomalies affecting the craniofacial region leading to an array of problems including the inability to feed properly.
OBJECTIVES


This study aimed to compare the effectiveness of specially designed audio-visual module over traditional instructional module in improving the assisted breastfeeding habits.
METHODOLOGY


Sixteen patients received training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module. Infants in both the groups received the standard care. These infants were followed up longitudinally for 6 months. During the follow up period, the growth parameters were recorded monthly. The knowledge, attitude, and practices of the mothers regarding feeding practices were assessed using KAP questionnaire.
RESULTS


There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices. Correspondingly, the growth parameters also showed significant difference.
CONCLUSION


The custom-made audio-visual module would help the mothers adapt better to the stressful situation following the birth of the infant affected with cleft lip and palate.",2020,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","['Sixteen patients received', 'mothers with cleft lip- and palate-affected infants']","['training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module', 'specially designed audio-visual module over traditional instructional module', 'Assisted breastfeeding technique']",[],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],16.0,0.0277095,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","[{'ForeName': 'Prashanth Sadashiva', 'Initials': 'PS', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, JSS Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12464']
130,32387962,"Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex.","OBJECTIVE


To assess the long-term analgesic effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex in patients with chronic pain syndrome.
METHODS


The study included 57 patients (orofacial pain, n = 26, pudendal neuralgia, n = 18, and neuropathic limb pain, n = 13) with an ""induction phase"" of 12 daily rTMS sessions for 3 weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months.
RESULTS


All pain measures significantly decreased from baseline to the end of the induction phase. Analgesic response, defined as pain intensity decrease ≥ 30% compared to baseline, was observed in 39 patients (68%), who could be differentiated from non-responders from the 7th rTMS session. At the end of the maintenance phase (D180), 27 patients (47%) were still responders. Anxio-depressive symptoms and quality of life also improved. The analgesic response at the end of the induction phase was associated with lower pain score at baseline, and the response at the end of the maintenance phase was associated with lower anxio-depressive score at baseline.
CONCLUSION


The analgesic efficacy of motor cortex rTMS can be maintained in the long term in various chronic pain conditions. Patients with high pain level and severe anxio-depressive symptoms may have a less favorable profile to respond to the procedure.
SIGNIFICANCE


The overall impact of rTMS treatment on daily life requires a multidimensional evaluation that goes beyond the analgesic effect that can be achieved.",2020,All pain measures significantly decreased from baseline to the end of the induction phase.,"['patients with chronic pain syndrome', '57 patients (orofacial pain, n\xa0=\xa026, pudendal neuralgia, n\xa0=\xa018, and neuropathic limb pain, n\xa0=\xa013) with an ""induction phase"" of 12 daily rTMS sessions for 3\xa0weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months', 'Patients with high pain level and severe anxio-depressive symptoms']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'rTMS', 'motor cortex rTMS']","['pain intensity decrease\xa0≥', 'anxio-depressive score', 'Anxio-depressive symptoms and quality of life', 'analgesic response', 'lower pain score', 'Analgesic response', 'All pain measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C1997249', 'cui_str': 'Pudendal neuralgia'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",57.0,0.0662332,All pain measures significantly decreased from baseline to the end of the induction phase.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Hodaj', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France. Electronic address: HHodaj@chu-grenoble.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Enkelejda', 'Initials': 'E', 'LastName': 'Hodaj', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dumolard', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Delon-Martin', 'Affiliation': 'Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Lefaucheur', 'Affiliation': 'EA 4391, Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.022']
131,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125']
132,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND


The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB.
OBJECTIVE


To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician.
METHODS AND RESULTS


We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs.
CONCLUSION


We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001']
133,32387472,Folinic acid improves the score of Autism in the EFFET placebo-controlled randomized trial.,"Autism spectrum disorders (ASD) are influenced by interacting maternal and environmental risk factors. High-dose folinic acid has shown improvement in verbal communication in ASD children. The EFFET randomized placebo-controlled trial (NCT02551380) aimed to evaluate the efficacy of folinic acid (FOLINORAL®) at a lower dose of 5 mg twice daily. Nineteen children were included in the EFFET trial. The primary efficacy outcome was improvement of Autism Diagnostic Observation Schedule (ADOS) score. The secondary outcomes were the improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety. The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively). We observed a greater change of ADOS global score (-2.78 vs. -0.4 points) and (-1.78 vs. 0.20 points) in the folinic acid group, compared to the placebo group. No serious adverse events were observed. This pilot study showed significant efficacy of folinic acid with an oral formulation that is readily available. It opens a perspective of therapeutic intervention with folinic acid but needs to be confirmed by a multi-center trial on a larger number of children.",2020,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","['Nineteen children were included in the EFFET trial', 'Autism spectrum disorders (ASD', 'ASD children']","['High-dose folinic acid', 'placebo', 'folinic acid (FOLINORAL®', 'Folinic acid', 'folinic acid']","['verbal communication', 'Autism Diagnostic Observation Schedule (ADOS) score', 'improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety', 'ADOS global score', 'serious adverse events', 'global ADOS score and social interaction and communication sub scores']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.384112,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","[{'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Leheup', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Rosa-Maria', 'Initials': 'RM', 'LastName': 'Guéant-Rodriguez', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Oussalah', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Quadros', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France; Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Guéant', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France. Electronic address: jean-louis.gueant@univ-lorraine.fr.'}]",Biochimie,['10.1016/j.biochi.2020.04.019']
134,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727']
135,32389606,Patient-reported receipt of goal-concordant care among seriously ill outpatients - prevalence and associated factors.,"CONTEXT


Goal-concordant care is an important indicator of high-quality care in serious illness.
OBJECTIVES


To estimate the prevalence of patient-reported receipt of goal-concordant care among seriously ill outpatients and identify factors associated with absence of patient-reported goal-concordance.
METHODS


Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness. Patients reported their prioritized healthcare goal and the focus of their current medical care; these items were matched to define receipt of goal-concordant care.
RESULTS


Of 405 patients with a prioritized healthcare goal, 58% reported receipt of goal-concordant care, 17% goal-discordant care, and 25% were uncertain of the focus of their care. Patient-reported receipt of goal-concordance differed by patient goal. For patients who prioritized extending life, 86% reported goal-concordant care, 2% goal-discordant care, and 12% were uncertain of the focus of their care. For patients who prioritized relief of pain and discomfort, 51% reported goal-concordant care, 21% goal-discordant care, and 28% were uncertain of the focus of their care. Patients who prioritized a goal of relief of pain and discomfort were more likely to report goal-discordant care than patients who prioritized a goal of extending life (RRR 22.20; 95%CI 4.59, 107.38).
CONCLUSION


Seriously ill outpatients who prioritize a goal of relief of pain and discomfort are less likely to report receipt of goal-concordant care than patients who prioritize extending life. Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.",2020,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"['patients who prioritize relief of pain and discomfort and promoting care aligned with that goal', 'Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness', '405 patients with a prioritized healthcare goal']",[],['pain and discomfort'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",405.0,0.0464339,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington. Electronic address: modes@uw.edu.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Heckbert', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington; Department of Bioethics and Humanities, University of Washington, Seattle, Washington.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.026']
136,32393092,Laughter yoga reduces the cortisol response to acute stress in healthy individuals.,"Stress is one of the foremost contributors to the development of psychiatric diseases. Since the prevalence of stress-related complaints is increasing, we are in need for affordable and effective treatment alternatives. Laughter yoga (LY), a popular method encouraging participants to simulate laughter and participate in yogic breathing exercises, is hypothesized to buffer negative effects of stress. Although widely practiced, empirical evidence for beneficial effects of LY is scarce. We investigated the acute effects of a single 30-min LY session on the autonomic, endocrine and psychological response to a standardized psychosocial stressor. Thirty-five healthy subjects (51% female) were randomly assigned to experience either a LY ( n  = 11), a relaxation breathing ( n  = 12) or a (non-intervention) control ( n  = 12) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G). Salivary cortisol, salivary alpha amylase, and subjective stress were assessed repeatedly throughout the experiment. We expected that LY and relaxation breathing group each show a downregulation of stress response indices compared to the control group. Further, we expected that LY has beneficial effects compared to relaxation breathing. The groups did not differ in salivary cortisol, alpha amylase or subjective stress reactivity during the 30-min intervention. However, in response to the TSST-G, the LY, but neither the relaxation breathing, nor the control condition, showed an attenuated cortisol stress response. These findings highlight the potential of LY to buffer the endocrine stress response. Therefore, LY could be used as a cheap and easily-to-implement add-on to more traditional stress interventions.LAY SUMMARYIn recent years, more and more people have reported to feel stressed. Although our body is well equipped to deal with acute stress, chronic stress can tire our system and contribute to illness in the long run. Therefore, we need affordable and effective measures to reduce stress. In this study we have investigated whether a single laughter yoga session can help us to deal with acute stress. Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation. As such, laughter yoga might be a cheap and easily-to-implement add-on to more traditional stress reduction interventions.",2020,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","['Thirty-five healthy subjects (51% female', 'healthy individuals']","['Laughter yoga (LY', 'single laughter yoga session', 'Laughter Yoga', 'relaxation breathing ( n \u2009=\u200912) or a (non-intervention) control ( n \u2009=\u200912) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G']","['cortisol stress response', 'Salivary cortisol, salivary alpha amylase, and subjective stress', 'cortisol response', 'salivary cortisol, alpha amylase or subjective stress reactivity', 'autonomic, endocrine and psychological response']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",35.0,0.0113006,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wirz', 'Affiliation': 'Department of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Dickinson', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal, Canada.""}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Department of Psychology, University of Constance, Constance, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1766018']
137,32393728,Comparison of Cardioprotective Effects of Propofol versus Sevoflurane in Pediatric Living Donor Liver Transplantation.,"BACKGROUND Our study compared the myocardiac protective effect of propofol vs. sevoflurane in pediatric patients receiving living donor liver transplantation (LDLT) surgery. MATERIAL AND METHODS We randomly and equally divided 120 children who underwent LDLT into a sevoflurane group and a propofol group. Preoperative, intraoperative, and postoperative data were collected and compared between the 2 groups. The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured. RESULTS There was no statistically significant difference in the characteristics of children in the 2 groups. Compared with T0, the levels of IL-6 and TNF-alpha at T1, T2, and T3 were higher, while the HMGB1 at T2 and T3 were higher (P<0.05). A similar trend for IL-6, TNF-alpha, and HMGB1 at different time points in the 2 groups was observed. Compared with T0, the cTnI and CK-MB at T2 and T3 were significantly higher (P<0.05), but there was no significant difference at different time points in the 2 groups. For the adverse events, there was no significant difference between the 2 groups. CONCLUSIONS Our study shows that the cardioprotective effect in pediatric patients undergoing living donor liver transplantation is similar with propofol and sevoflurane anesthesia.",2020,"The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured.","['pediatric patients undergoing living donor liver transplantation', 'Pediatric Living Donor Liver Transplantation', '120 children who underwent', 'pediatric patients receiving living donor liver transplantation (LDLT) surgery']","['propofol', 'sevoflurane anesthesia', 'LDLT', 'Propofol', 'sevoflurane', 'propofol vs. sevoflurane', 'Sevoflurane']","['Preoperative, intraoperative, and postoperative data', 'levels of IL-6 and TNF-alpha', 'IL-6, TNF-alpha, and HMGB1', 'concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}]",120.0,0.0693214,"The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured.","[{'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Shaoting', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}]",Annals of transplantation,['10.12659/AOT.923398']
138,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION


Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice.
MATERIAL AND METHODS


Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet.
PRIMARY OUTCOMES


Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism.
SECONDARY OUTCOMES


Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation.
DISCUSSION


This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
CLINICAL TRIAL REGISTRATION


NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024']
139,32394757,Economic evaluation of a multimodal intervention in pre-frail and frail older people with diabetes mellitus: the MID-FRAIL project.,"BACKGROUND


The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality adjusted life years (QALYs) in different European countries.
METHODS


The MID-FRAIL study was a cluster randomized multicentre trial conducted in seven European countries. A cost-utility analysis was carried out based on this study, conducted from the perspective of the health care system with a time horizon of one year. Univariate and probabilistic analysis were carried out to test the robustness of the results.
RESULTS


The cost estimation showed the offsetting health effect of the intervention program on total health care costs. The mean annual health care costs were 25% higher among patients in usual care. The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.
CONCLUSIONS


The MID-FRAIL intervention program showed to be the dominant option in comparison with usual care practice. It saved costs to the health care system and achieved worthwhile health gains. This finding should encourage its implementation, at least, in the trial participant countries.",2020,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"['frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality-adjusted life years (QALYs) in different European countries', 'pre-frail and frail older people with diabetes mellitus', 'seven European countries']","['multi-modal intervention', 'multimodal intervention']","['incremental cost-utility ratio (ICUR', 'total health care costs', 'mean annual health care costs']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",25.0,0.0428674,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"[{'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Peña-Longobardo', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Oliva-Moreno', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Neboa', 'Initials': 'N', 'LastName': 'Zozaya', 'Affiliation': 'Department of Health Economics, Weber, Madrid Spain, University of Las Palmas de Gran Canaria , Las Palmas De Gran Canaria, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Aranda-Reneo', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya (UIC) , Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Laosa', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe , Madrid, Spain.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sinclair', 'Affiliation': 'Foundation for Diabetes Research in Older People, Diabetes Frail Ltd , Luton, UK.'}, {'ForeName': 'Leocadio', 'Initials': 'L', 'LastName': 'Rodríguez-Mañas', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe , Madrid, Spain.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2020.1766970']
140,32335159,Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women.,"BACKGROUND


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


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


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


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


The present study reveals that 6-weeks daily supplementation with a micronutrient blend elicits positive changes in brain neurochemistry. This is the first study to demonstrate that a putative CR mimetic increases brain GSH concentrations and improves neuroprotection and neuroenergetics in the brain of healthy humans. This study was registered at www.clinicaltrials.gov as NCT02439983.",2020,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","['Healthy middle-aged men and women (N\u202f=\u202f63 [33 women]; age: 40-60 years', 'healthy middle-aged men and women', 'healthy humans']","['putative CR mimetic', 'putative CR mimetic or placebo', 'neurometabolites: GSH, Glutamate (Glu), Glutamine (Gln) and N-Acetylaspartate (NAA', 'Proton ( 1 H) Magnetic Resonance Spectroscopic (MRS', 'placebo']","['marker of antioxidant and cellular redox status', 'NAA/H 2 O, a marker of neuronal integrity', 'brain GSH concentrations', 'glutathione concentrations', 'glutathione (GSH', 'Glu/Gln ratio, a marker of excitatory neurotransmission and bioenergetics']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}]",,0.190371,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mastaloudis', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sheth', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA. Electronic address: chandni.sheth@utah.edu.'}, {'ForeName': 'Shelly N', 'Initials': 'SN', 'LastName': 'Hester', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Wood', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prescot', 'Affiliation': 'Department of Radiology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McGlade', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Perry F', 'Initials': 'PF', 'LastName': 'Renshaw', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Yurgelun-Todd', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.04.017']
141,32397926,"2B, 2C, or 3: What Should Be the Angiographic Target for Endovascular Treatment in Ischemic Stroke?","Background and Purpose- A score of ≥2B on the modified Thrombolysis in Cerebral Infarction scale is generally regarded as successful reperfusion after endovascular treatment for ischemic stroke. The extended Thrombolysis in Cerebral Infarction (eTICI) includes a 2C grade, which indicates near-perfect reperfusion. We investigated how well the respective eTICI scores of 2B, 2C, and 3 correlate with clinical outcome after endovascular treatment. Methods- We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands. We included patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available. Our primary outcome was the distribution on the modified Rankin Scale at 90 days per eTICI grade. We performed (ordinal) logistic regression analyses, using eTICI 2B as reference group, and adjusted for potential confounders. Results- In total, 2807/3637 (77%) patients met the inclusion criteria. Of these, 17% achieved reperfusion grade eTICI 0 to 1, 14% eTICI 2A, 25% eTICI 2B, 12% eTICI 2C, and 32% eTICI 3. Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01). Procedure times decreased with increasing reperfusion grades. We found a positive association between reperfusion grade and functional outcome, which continued to increase after eTICI 2B (adjusted common odds ratio, 1.22 [95% CI, 0.96-1.57] for eTICI 2C versus 2B; adjusted common odds ratio, 1.33 [95% CI, 1.09-1.62] for eTICI 3 versus 2B). Conclusions- Our results indicate a continuous relationship between reperfusion grade and functional outcome, with eTICI 3 leading to the best outcomes. Although this implies that interventionists should aim for the highest possible reperfusion grade, further research on the optimal strategy is necessary.",2020,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"['patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available', 'Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands']","['Methods', 'Endovascular Treatment', ' and Purpose', 'Conclusions']","['reperfusion grade eTICI', 'Cerebral Infarction scale', 'occlusion location', 'distribution on the modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.078079,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Center for Medical Decision Making, Erasmus MC University Medical Center Rotterdam, the Netherlands (H.F.L.).'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, China (G.Z.).'}, {'ForeName': 'Ido R', 'Initials': 'IR', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, the Hague, the Netherlands (I.R.v.d.W.).'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, the Netherlands (A.C.G.M.v.E.).'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028891']
142,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND


Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue.
OBJECTIVE


In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS.
METHODS


This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS).
RESULTS


Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation.
CONCLUSION


This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
143,32396250,"Comparison of 40% trichloroacetic acid and cryotherapy for the treatment of plantar warts: A single-blind, randomized clinical trial.","Plantar warts can cause pain near the toes and the sole of the foot and may result in referral for treatment. This study was aimed at comparing 40% trichloroacetic acid (TCA) and cryotherapy (Cryo) for the treatment of plantar warts. This single-blind, randomized clinical trial was performed on 60 subjects presenting with plantar wart in Sabzevar, Iran in 2018. The first intervention group was treated with 40% TCA in four sessions within 4 weeks. The second intervention group was treated with Cryo using liquid nitrogen in four sessions within 8 weeks. The mean (SD) age of subjects was 20.16 ± 5.96 years and 68.33% (n = 41) were male. Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = .648). Findings suggest that although 40% TCA was almost as effective as Cryo in the treatment of plantar warts, considering the lower adverse effects of TCA 40% group as compared to the Cryo group, it could be a proper alternative.",2020,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","['60 subjects presenting with plantar wart in Sabzevar, Iran in 2018', 'The mean (SD) age of subjects was 20.16 ±\u20095.96\u2009years and 68.33% (n=41) were male', 'plantar warts']","['Cryo using liquid nitrogen', 'TCA', 'trichloroacetic acid (TCA) and cryotherapy (Cryo', 'trichloroacetic acid and cryotherapy', '40% TCA']",['resolution rate of warts'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}]","[{'cui': 'C0043037', 'cui_str': 'Verruca'}]",60.0,0.041248,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kheirkhah', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Smitha', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Clinical Research Pvt Ltd, Bangalore University, Bangalore, Karnataka, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Dermatologic therapy,['10.1111/dth.13559']
144,32396179,Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT01719887.",2020,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['closed humeral shaft fractures', 'patients with closed humeral shaft fracture, internal fixation surgery', ' 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial', 'Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma', 'Patients', '2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019', '82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion', 'With Closed Displaced Humeral Shaft Fractures', '82 patients who were randomized (mean age, 48.9 years']","['surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing', 'Surgery vs Functional Bracing', 'surgical treatment with open reduction and internal plate fixation (n\u2009=\u200938) or to nonsurgical treatment with functional bracing (n\u2009=\u200944']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand', 'DASH) score', 'functional outcomes', 'fracture nonunion']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}]",82.0,0.141729,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3182']
145,32396180,Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT02363712.",2020,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","['Swiss university hospital', 'Participants (N\u2009=\u2009220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017', '220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up', 'People With Knee Osteoarthritis', 'people with symptomatic knee osteoarthritis', 'participants with knee pain from osteoarthritis']","['Biomechanical Footwear', 'biomechanical footwear therapy', 'calibrated biomechanical footwear therapy', 'biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n\u2009=\u2009111) or to control footwear (n\u2009=\u2009109) that had visible outsole pods that were not adjustable and did not create a convex walking surface']","['pain and physical function', 'WOMAC physical function subscore', 'WOMAC stiffness subscore', 'Knee Pain', 'serious adverse events', 'pain', 'knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms', 'mean standardized WOMAC pain subscore', 'WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms', 'WOMAC global score']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",220.0,0.172357,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heldner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lenz', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Harald M', 'Initials': 'HM', 'LastName': 'Bonel', 'Affiliation': 'Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Hawker', 'Affiliation': 'Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.3565']
146,32397728,Nanolaser in cataract surgery and its impact on corneal endotelium.,"PURPOSE


To compare safety and efficacy of new nanolaser photofragmentation technique with standard ultrasound phacoemulsification cataract surgery technique. Metods: A group of 20 patients - 40 eyes who underwent bilateral cataract surgery, one eye with ultrasound phacoemulsification (group I), n = 20 fellow eye with nanosecond laser framentation (group II ). Lens Opacities Classification System III was used to classify cataract stage. All 40 eyes had stage III cataract, Nucleus Opalescence was NO2 - NO3. Uncorrected visual acuity (UCVA), endothelial cells density (DEC), hexagonal cells rate, index of endothelial cells pleomorfism, and corneal thickness were evaluated prior to surgery and at day 7 follow up.
RESULTS


All 40 eyes had uneventful surgery,without complications. Preoperative UCVA in group I was 0,70±0,07 and 0,68 ± 0,10 in group II. At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS). The mean DEC (cells/mm2) before surgery was 2508 ± 205,54 in group 1 and 2472 ± 287,85 in group II. After surgery density decreased to 2024,92±271,50 in group 1 and 2138,5 ± 390,85 in group II. Difference in endothelial cells decrease between groups showed no statistical significance. There was no statistical significance in differences of hexagonal cells rate and corneal thickness between both groups pre and postoperatively.
CONCLUSION


Nanolaser lens photofragmentation and ultrasound phacoemulsification can be considered equal regarding impact on endothelial cells.",2019,"At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS).","['Metods', 'All 40 eyes had stage III cataract, Nucleus Opalescence was NO2 - NO3', '20 patients - 40 eyes who underwent']","['new nanolaser photofragmentation technique with standard ultrasound phacoemulsification cataract surgery technique', '20 fellow eye with nanosecond laser framentation', 'Nanolaser lens photofragmentation and ultrasound phacoemulsification', 'Preoperative UCVA', 'bilateral cataract surgery, one eye with ultrasound phacoemulsification']","['uneventful surgery,without complications', 'hexagonal cells rate and corneal thickness', 'safety and efficacy', 'endothelial cells decrease', 'corneal endotelium', 'Uncorrected visual acuity (UCVA), endothelial cells density (DEC), hexagonal cells rate, index of endothelial cells pleomorfism, and corneal thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0281268,"At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Juhás', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Juhás Ml', 'Affiliation': ''}]",Ceska a slovenska oftalmologie : casopis Ceske oftalmologicke spolecnosti a Slovenske oftalmologicke spolecnosti,['10.31348/2019/5/4']
147,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND


With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function.
OBJECTIVES


The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults.
METHOD


In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation.
RESULTS


There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
CONCLUSION


The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
148,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777']
149,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


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


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


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


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


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
150,32304981,Opioid overdose reversals using naloxone in New York City by people who use opioids: Implications for public health and overdose harm reduction approaches from a qualitative study.,"BACKGROUND


Adverse reactions to naloxone, such as withdrawal symptoms and aggression, are widely recognised in the literature by pharmaceutical manufacturers and clinical practitioners as standard reactions of individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose. This paper seeks to provide a differentiated view on reactions to naloxone that may have important implications for public health and harm reduction approaches.
METHODS


Analyses from a qualitative investigation embedded within a 5-year Randomised Controlled Trial (RCT) examined the risks and benefits of Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training) in various populations of people who use opioids in New York City. The qualitative experiences (obtained through semi-structured interviews) of 46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied. Situational analysis and inductive content analysis of interview data focused upon overdose reversals in an attempt to provide understandings of the various adverse effects associated with naloxone from their perspective. These analyses were supplemented by data sessions within the research team during which the findings obtained from situational analysis and inductive content analysis were reviewed and complemented by deductive (clinical) appraisals of the various physical and psychological effects associated with the overdose reversals.
RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone. These outcomes are here termed, (i) 'rage' (describing a wide range of angry, hostile and/or aggressive outbursts), (ii) 'withdrawal symptoms,' and (iii) 'not rage, not withdrawal' (i.e., a wide range of short-lived, 'harmless' conditions (such as temporary amnesia, mild emotional outbursts, or physical discomfort) that do not include rage or withdrawal symptoms).
CONCLUSION


Physical and psychological reactions to naloxone should not be understood exclusively as a consequence of acute, opioid-related, withdrawal symptoms. The three distinct and interconnected reversal outcomes identified in this study are considered from a harm reduction policy perspective and are further framed by concepts associated with 'mediated toxicity' (i.e., harm triggered by medicine). The overall conclusion is that harm reduction training programmes that are aligned to the policy and practice of take home naloxone may be strengthened by including awareness and training in how to best respond to 'rage' associated with overdose reversal following naloxone administration by people who use opioids and other laypersons.",2020,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","['46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied', 'individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose', 'various populations of people who use opioids in New York City']","['Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training', 'naloxone']",['successful opioid overdose reversal'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",,0.0390371,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom.""}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London SE5 8AZ, United Kingdom.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102751']
151,32315958,"Effects of oral butyrate and inulin supplementation on inflammation-induced pyroptosis pathway in type 2 diabetes: A randomized, double-blind, placebo-controlled trial.","PURPOSE


Pyroptosis, a form of inflammatory programmed cell death, is activated in diabetic patients. This study was conducted to investigate the effects of daily consumption of sodium butyrate (NaBut) and high-performance (HP) inulin supplementation, individually or in combination, on the expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress in patients with type 2 diabetes (T2DM).
METHODS


In this study, we conducted a randomized, double-blinded, placebo-controlled clinical involving sixty patients with type 2 diabetes. Participants received 600 mg/d of NaBut (group A), 10 g/d of HP inulin (group B), 600 mg/d of NaBut + 10 g/d of HP inulin (group C) or placebo (group D) for 45 consecutive days. We assessed the pyroptosis-related genes mRNA expression in peripheral blood mononuclear cells (PBMCs), as well as the plasmatic levels of miR-146a and miR-9 before and after the intervention. Moreover, blood samples of the patients at baseline and following the intervention were tested for total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA). This study was registered on the Iranian Registry of Clinical Trials website (identifier: IRCT201605262017N29; https://www.irct.ir/).
RESULTS


Following butyrate supplementation, the relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18 were significantly downregulated (p < 0.05). Furthermore, butyrate and concomitant use of butyrate and inulin caused a significant increase in the fold change of miR-146a and miR-9 compared with the placebo group (p < 0.05). Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
CONCLUSION


In summary, the change in expression level of miR-146a-5p and miR-9-5p due to butyrate supplementation may have a pivotal role in alleviating of diabetes via inhibiting pyroptosis by targeting TLR2 and NF-κB1. These microRNAs might be considered as potential therapeutic targets in the treatment of type 2 diabetes but further researches is required to prove the link.",2020,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","['type 2 diabetes', 'sixty patients with type 2 diabetes', 'patients with type 2 diabetes (T2DM', 'diabetic patients']","['oral butyrate and inulin supplementation', 'placebo', '600\xa0mg/d of NaBut', 'NaBut\xa0+\xa010\xa0g/d of HP inulin', 'sodium butyrate (NaBut) and high-performance (HP) inulin supplementation', 'HP inulin']","['total antioxidant capacity', 'relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18', 'expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress', 'fold change of miR-146a and miR-9', 'blood samples', 'superoxide dismutase', 'total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C2610960', 'cui_str': 'Caspase-1 Dependent Cell Death'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C3884166', 'cui_str': 'MIRN9 microRNA, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]",60.0,0.227835,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Students Research Committee, School of Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad Asghari', 'Initials': 'MA', 'LastName': 'Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bahadir Rostamzadeh', 'Initials': 'BR', 'LastName': 'Shabestari', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nasirzadeh', 'Affiliation': 'School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mansoori', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Ghavami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ghafaris@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155101']
152,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
153,32395750,To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial.,"STUDY QUESTION


Is the clinical pregnancy rate (CPR) following a frozen embryo transfer (FET) in a natural cycle (NC) higher after spontaneous ovulation than after triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET]?
SUMMARY ANSWER


The CPR did not vary significantly between the two FET preparation protocols.
WHAT IS KNOWN ALREADY


Although the use of FET is continuously increasing, the most optimal endometrial preparation protocol is still under debate. For transfer in the NC specifically, conflicting results have been reported in terms of the outcome following spontaneous or triggered ovulation.
STUDY DESIGN, SIZE, DURATION


In a tertiary hospital setting, subjects were randomized with a 1:1 allocation into two groups between January 2014 and January 2019. Patients in group A underwent an NC-FET, while in group B, a modified NC-FET was performed with a subcutaneous hCG injection to trigger ovulation. In neither group was additional luteal phase support administered. All embryos were vitrified-warmed on Day 3 and transferred on Day 4 of embryonic development. The primary outcome was CPR at 7 weeks. All patients were followed further until 10 weeks of gestation when the ongoing pregnancy rate (OPR) was defined by the observation of foetal cardiac activity on ultrasound scan. Other secondary outcomes included biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET.
PARTICIPANTS/MATERIALS, SETTING, METHODS


A total of 260 patients (130 per study arm) were randomized, of whom 12 withdrew consent after study arm allocation. A total of 3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons. Of the 229 actually commencing monitoring for the study FET cycle, 7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a spontaneous LH surge before the ovulation trigger could be administered, although they were allocated to group B. Given the above, an intention-to-treat (ITT) analysis was performed taking into account 248 patients (125 in group A and 123 in group B), as well as a per protocol (PP) analysis on a subset of 173 patients (110 in group A and 63 in group B).
MAIN RESULTS AND THE ROLE OF CHANCE


Demographic features were evenly distributed between the study groups, as were the relevant fresh and frozen ET cycle characteristics. According to the ITT analysis, the CPR and OPR in group A (33.6% and 27.2%, respectively) and group B (29.3% and 24.4%, respectively) did not vary significantly [relative risk (RR) 0.87, 95% CI (0.60;1.26), P = 0.46 and RR 0.90, 95% CI (0.59;1.37), P = 0.61, respectively]. Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups. In contrast, more clinic visits and blood samplings for cycle monitoring were required in the NC-FET group (4.05 ± 1.39) compared with the modified NC-FET group (3.03 ± 1.16, P = <0.001), while the number of ultrasound scans performed were comparable (1.70 ± 0.88 in group A versus 1.62 ± 1.04 in group B). The additional PP analysis was in line with the ITT results: CPR in group A was 36.4% versus 38.1% in group B [RR 1.05, 95% CI (0.70;1.56), P = 0.82].
LIMITATIONS, REASONS FOR CAUTION


The results are limited by the high drop-out rate for the PP analysis in the modified NC-FET group as more than one-third of the subjects allocated to this group ovulated spontaneously before ovulation triggering. Nonetheless, this issue is inherent to routine clinical practice and is an important observation of an event that can only be avoided by performing a very extensive monitoring that limits the practical advantages associated with modified NC-FET. Furthermore, although this is the largest randomized controlled trial (RCT) investigating this specific research question so far, a higher sample size would allow smaller differences in clinical outcome to be detected, since currently they may be left undetected.
WIDER IMPLICATIONS OF THE FINDINGS


This RCT adds new high-quality evidence to the existing controversial literature concerning the performance of NC-FET versus modified NC-FET. Based on our results showing no statistically significant differences in clinical outcomes between the protocols, the treatment choice may be made according to the patient's and treating physician's preferences. However, the modified NC-FET strategy reduces the need for hormonal monitoring and may therefore be considered a more patient-friendly and potentially cost-effective approach.
STUDY FUNDING/COMPETING INTEREST(S)


No specific funding was available for this study. None of the authors have a conflict of interest to declare with regard to this study.
TRIAL REGISTRATION NUMBER


NCT02145819.
TRIAL REGISTRATION DATE


8 January 2014.
DATE OF FIRST PATIENT’S ENROLMENT


21 January 2014.",2020,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"['’S ENROLMENT\n\n\n21 January 2014', '3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons', '7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a', '260 patients (130 per study arm']","['FET', 'triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET', 'NC-FET', 'frozen embryo transfer (FET']","['clinical pregnancy rate (CPR', 'biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET', 'CPR', 'pregnancy rate (OPR', 'spontaneous LH surge', 'Biochemical pregnancy rate and early pregnancy loss', 'clinic visits and blood samplings for cycle monitoring', 'number of ultrasound scans']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",3.0,0.159805,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stubbe', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Valencian Institute of Infertility Reproductive Medicine Associates (IVI-RMA) Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Landuyt', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roelens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Camus', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van de Vijver', 'Affiliation': 'Fertiliteit, AZ Sint-Jan, Ruddershove 10, 8000 Brugge, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa026']
154,32398466,Treatment of neurogenic lower urinary tract symptoms: main contributions from 2018 and 2019.,"PURPOSE OF REVIEW


This review aims to update the studies involving the treatment of lower urinary tract symptoms (LUTS) in neurogenic patients, published in the last two years.
RECENT FINDINGS


Treatment of neurogenic LUTS (NLUTS) patients with β3 adrenoreceptor agonists was investigated in real-life conditions. A randomized controlled trial compared the efficacy of antimuscarinics versus onabotulinum toxin A in neurogenic patients. The use of desmopressin to treat nocturia in multiple sclerosis patients is also reported. The long-term treatment with BontA efficacy, its discontinuation, and possible strategies to maintain patients on treatment were also evaluated. Sacral neuromodulation and tibial nerve stimulation are continuously being evaluated in neurogenic patients, especially in the last years.
SUMMARY


The management of urinary tract infections and vesical lithiasis, two common complications in NLUTS patients, and the management of both these patients was assessed in clinical trials.A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.",2020,A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.,"['neurogenic patients', 'multiple sclerosis patients']","['antimuscarinics versus onabotulinum toxin A', 'desmopressin']",['urinary tract infections and vesical lithiasis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023869', 'cui_str': 'Lithiasis'}]",,0.0265182,A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Mendes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martins-Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}]",Current opinion in urology,['10.1097/MOU.0000000000000774']
155,32398500,The Effect of Rehospitalization and Emergency Department Visits on Subsequent Adherence to Weight Telemonitoring.,"BACKGROUND


Weight telemonitoring may be an effective way to improve patients' ability to manage heart failure and prevent unnecessary utilization of health services. However, the effectiveness of such interventions is dependent upon patient adherence.
OBJECTIVE


The purpose of this study was to determine how adherence to weight telemonitoring changes in response to 2 types of events: hospital readmissions and emergency department visits.
METHODS


The Better Effectiveness After Transition-Heart Failure trial examined the effectiveness of a remote telemonitoring intervention compared with usual care for patients discharged to home after hospitalization for decompensated heart failure. Participants were followed for 180 days and were instructed to transmit weight readings daily. We used Poisson regression to determine the within-person effects of events on subsequent adherence.
RESULTS


A total of 625 events took place during the study period. Most of these events were rehospitalizations (78.7%). After controlling for the number of previous events and discharge to a skilled nursing facility, the rate for adherence decreased by nearly 20% in the 2 weeks after a hospitalization compared with the 2 weeks before (adjusted rate ratio, 0.81; 95% confidence interval: 0.77-0.86; P < .001).
CONCLUSIONS


Experiencing a rehospitalization had the effect of diminishing adherence to daily weighing. Providers using telemonitoring to monitor decompensation and manage medications should take advantage of the potential ""teachable moment"" during hospitalization to reinforce the importance of adherence.",2020,The Better Effectiveness,['patients discharged to home after hospitalization for decompensated heart failure'],['remote telemonitoring intervention'],"['Better Effectiveness', 'rate for adherence']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0488464,The Better Effectiveness,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': 'Sarah C. Haynes, PhD, MPH Department of Pediatrics, University of California Davis, Sacramento, California. Daniel J. Tancredi, PhD Department of Pediatrics and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Kathleen Tong, MD Adventist Heart and Vascular Institute, St. Helena, California. Jeffrey S. Hoch, PhD Department of Public Health Sciences and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Michael K. Ong, MD, PhD Division of General Internal Medicine and Health Services Research, University of California Los Angeles and VA Greater Los Angeles Healthcare System, California. Theodore G. Ganiats, MD Department of Family Medicine and Public Health, University of California San Diego School of Medicine, La Jolla, California. Lorraine S. Evangelista, PhD, RN Sue and Bill Gross School of Nursing, University of California Irvine, California. Jeanne T. Black, PhD, MBA Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California. Andrew Auerbach, MD, MPH Department of Medicine, University of California San Francisco School of Medicine. Patrick S. Romano, MD, MPH Division of General Medicine and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': ''}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': ''}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': ''}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': ''}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': ''}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000689']
156,32396535,"Proficiency based progression simulation training significantly reduces utility strikes; A prospective, randomized and blinded study.","OBJECTIVES


We evaluated a simulation-based training curriculum with quantitatively defined performance benchmarks for utility workers location and excavation of utility services.
BACKGROUND


Damaging buried utilities is associated with considerable safety risks to workers and substantial cost to employers.
METHODS


In a prospective, randomized and blinded study we assessed the impact of Proficiency Based Progression (PBP) simulation training on the location and excavation of utility services work.
RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group. When implemented across all workers in the same division there was a 35-61% reduction in utility strikes (p = 0.028) and an estimated cost saving of £116,000 -£2,175,000 in the 12 months (47,000 work hours) studied.
CONCLUSIONS


The magnitude of the training benefit of PBP simulation training in the utilities sector appears to be the same as it is in surgery, cardiology and procedure-based medicine.
APPLICATION


Quality-assured utility worker simulation training significantly reduces utility damage and associated costs.",2020,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.",[],"['Proficiency based progression simulation training', 'PBP simulation training', 'Proficiency Based Progression (PBP) simulation training']","['performance errors', 'utility strikes']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.038472,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.","[{'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Faculty of Life and Health Sciences, Ulster University, Magee Campus, Londonderry, Northern Ireland, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': 'Group Training and Development Manager, ReachActive Unit 4B Lough Sheever Corporate Park, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cleary', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hamilton', 'Affiliation': 'ReachActive, Hertford, England, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGlinchey', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kiely', 'Affiliation': 'Flux Learning Ltd., Clonakilty, Co Cork, Ireland.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Bunting', 'Affiliation': 'School of Psychology, Coleraine, Co. Londonderry, Northern Ireland, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0231979']
157,32396564,The effect of monetary incentive on survey response for vulnerable children and youths: A randomized controlled trial.,"AIM


In surveys non-responders may introduce bias and lower the validity of the studies. Ways to increase response rates are therefore important. The purpose of the study was to investigate if an unconditional monetary incentive can increase the response rate for vulnerable children and youths in a postal questionnaire survey.
METHODS


The study was designed as a randomized controlled trial. The study population consisted of 262 children and youth who participated in an established intervention study aimed at creating networks for different groups of vulnerable children and youths. The mean age of the participants was 16.7 years (range 11-28) and 67.9% were female. The questionnaire was adapted to three different age groups and covered different aspects of the participants' life situation, including the dimensions from the Strengths and Difficulties Questionnaire (SDQ). In the follow-up survey, participants were randomly allocated to two groups that either received a €15 voucher for a supermarket together with the questionnaire or only received the questionnaire. We used Poisson regression to estimate the differences in response rate (Rate Ratio RR) between the intervention group and the control group.
RESULTS


The response rate was 75.5% in the intervention group and 42.9% in the control group. The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17). We did not find any significant differences in scales scores between the two groups for the five scales of the SDQ. In stratified analyses, we found the effect of the incentive to be higher for males (RR 2.81; 95% CI 1.61-4.91) than for females (1.43; 95% CI 1.12-1.84).
CONCLUSIONS


Monetary incentives can increase the response rate for vulnerable children and youths in surveys.
TRIAL REGISTRATION


The trial was retrospectively registered at ClinicalTrials.gov Identifier: NCT01741675.",2020,"The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17).","['The mean age of the participants was 16.7 years (range 11-28) and 67.9% were female', 'vulnerable children and youths', '262 children and youth who participated in an established intervention study aimed at creating networks for different groups of vulnerable children and youths', 'vulnerable children and youths in a postal questionnaire survey', 'vulnerable children and youths in surveys']","['monetary incentive', '€15 voucher for a supermarket together with the questionnaire or only received the questionnaire']","['survey response', 'response rate', 'response rate (Rate Ratio RR', 'scales scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",262.0,0.0763144,"The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17).","[{'ForeName': 'Jan Hyld', 'Initials': 'JH', 'LastName': 'Pejtersen', 'Affiliation': 'VIVE-The Danish Center for Social Science Research, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0233025']
158,32396578,Special footwear designed for pregnant women and its effect on kinematic gait parameters during pregnancy and postpartum period.,"During pregnancy, an array of changes occurs in women body to enable the growth and development of the future baby and the consequent delivery. These changes are reflected in the range of motion of trunk, pelvis, lower limbs and other body segments, affect the locomotion and some of these changes may persist to the postpartum period. The aim of this study was to describe the changes affecting the gait during pregnancy and to determine the effect of tested footwear on kinematic gait characteristics during pregnancy as previous studies indicate that special orthopaedic insoles and footwear might be useful in prevention of the common musculoskeletal pain and discomfort related to pregnancy. Participants from the control group (n = 18), without any intervention, and the experimental group (n = 23), which was wearing the tested shoes, were measured at their 14, 28 and 37 gestational weeks and 28 weeks postpartum to capture the complete pregnancy-related changes in gait. The gait 3D kinematic data were obtained using Simi Motion System. The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern. The effect of tested footwear on kinematic gait pattern changes may be explained by its preventive effect against the foot arches falling. In the control group, changes associated previously with the foot arches falling and hindfoot hyperpronation were observed during advanced phases of pregnancy and postpartum, e.g. increase in knee flexion or increase in spinal curvature. For the comprehensive evaluation of the tested footwear on pregnancy gait pattern, future studies combining the kinematic and dynamic plantographic methods are needed.",2020,"The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern.",['pregnant women'],[],"['knee flexion or increase in spinal curvature', 'kinematic gait parameters', 'foot arches falling and hindfoot hyperpronation']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}]",,0.0341883,"The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gimunová', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zvonař', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sebera', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Turčínek', 'Affiliation': 'Department of Informatics, Faculty of Business and Economics, Mendel University, Brno, Czech Republic.'}, {'ForeName': 'Kateřina', 'Initials': 'K', 'LastName': 'Kolářová', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}]",PloS one,['10.1371/journal.pone.0232901']
159,32396592,Kinetic profile and urinary excretion of phenyl-γ-valerolactones upon consumption of cranberry: a dose-response relationship.,"Cranberries are a rich source of poly(phenols), mainly monomeric and oligomeric flavan-3-ols. However, information on the appearance of their main circulating microbial metabolites, namely phenyl-γ-valerolactones and phenylvaleric acid, is lacking despite its relevance to understanding the health effects attributed to cranberries. The aim of this study was to evaluate the absorption, metabolism and urinary excretion of cranberry flavan-3-ols through the targeted analysis of phenyl-γ-valerolactones and their related phenylvaleric acids, considering also their potential as biomarkers of flavan-3-ol intake and inter-individual variability in their appearance in plasma and urine. A six-arm acute crossover, randomized, double-blinded, controlled intervention trial was performed in ten healthy males who consumed a cranberry juice drink (375, 716, 1131, 1396, 1741 mg of total flavan-3-ols) or an isocaloric control drink with one-week washout. Plasma and urine were analyzed by UHPLC-ESI-QqQ-MS/MS and 22 compounds were identified. Glucuronide and sulfate conjugates of 5-(3',4'-dihydroxyphenyl)-γ-valerolactone were the main circulating and excreted metabolites after cranberry juice intake, with glucuronidation appearing to be the most favorable conjugation route. These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake. A high inter-individual variability in circulating and urinary metabolite levels was observed and, interestingly, some subjects seemed to display a greater efficiency in metabolizing flavan-3-ols and producing phenyl-γ-valerolactones.",2020,"These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake.","['ten healthy males who consumed a cranberry juice drink (375, 716, 1131, 1396, 1741 mg of total flavan-3-ols) or an']","['isocaloric control drink with one-week washout', ""5-(3',4'-dihydroxyphenyl)-γ-valerolactone"", 'Glucuronide']","['circulating and urinary metabolite levels', 'absorption, metabolism and urinary excretion of cranberry flavan-3-ols', 'Plasma and urine', 'maximum plasma concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1572601', 'cui_str': 'CRANBERRY JUICE'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0443441', 'cui_str': 'Valerolactone'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.0386886,"These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Favari', 'Affiliation': 'Human Nutrition Unit, Department of Food & Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Curti', 'Affiliation': ''}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Istas', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heiss', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Mateos', 'Affiliation': ''}]",Food & function,['10.1039/d0fo00806k']
160,32335900,"The impact of respiratory protective equipment on difficult airway management: a randomised, crossover, simulation study.","The current international COVID-19 health crisis underlines the importance of adequate and suitable personal protective equipment for clinical staff during acute airway management. This study compares the impacts of standard air-purifying respirators and powered air-purifying respirators during simulated difficult airway scenarios. Twenty-five anaesthetists carried out four different standardised difficult intubation drills, either unprotected (control), or wearing a standard or a powered respirator. Treatment times and wearer comfort were determined and compared. In the wearer comfort evaluation form, operators rated mobility, noise, heat, vision and speech intelligibility. All anaesthetists accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™; 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope; 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope; and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard tracheal intubation by direct laryngoscopy, respectively. Videolaryngoscopy allowed the shortest intubation times regardless of the respiratory protective device used. Anaesthetists rated heat and vision significantly higher in the powered respirator group; however, noise levels were perceived to be significantly lower than in the standard respirator group. We conclude that standard and powered respirators do not significantly prolong simulated advanced intubation procedures.",2020,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.",[],"['standard air purifying respirators and powered air purifying respirators', 'respiratory protective equipment', 'standardised difficult intubation drills, either unprotected (control), or wearing a standard, or a powered respirator', 'Videolaryngoscopy']","['Total mean (SD) intubation times', 'Anaesthetists rated heat and vision', 'operators rated mobility, noise, heat, vision, and speech intelligibility', 'Treatment times and wearer comfort', 'noise levels']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0444717,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arlidge', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sicinski', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Anaesthesia,['10.1111/anae.15102']
161,32289619,Serum osteoprotegerin as a long-term predictor for patients with stable coronary artery disease and its association with diabetes and statin treatment: A CLARICOR trial 10-year follow-up substudy.,"BACKGROUND AND AIMS


Elevated circulating levels of osteoprotegerin (OPG) are known to add to the prediction of cardiovascular mortality. Our objective was to clarify the long-term risk associated with serum OPG and the possible influence of diabetes and statins on OPG levels in patients with stable coronary artery disease (CAD).
METHODS


We assessed the placebo-treated group (n = 1998) from the CLARICOR trial (NCT00121550), a cohort with stable CAD. At entry, 15% of the participants had diabetes and 41% received statins. Serum OPG levels were measured in blood drawn at randomization. Participants were followed through public registers for 10 years.
RESULTS


OPG levels correlated positively with diabetes status, age, CRP and female sex, but negatively with the use of statins. CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001. The participants without diabetes treated with statins presented with significantly lower serum OPG levels than the corresponding non-statin-users (p < 0.0001). However, statin use showed no association with OPG levels in the participants with diabetes. High OPG levels at entry showed long-term associations with all-cause mortality and cardiovascular events (hazard ratio associated with factor 10 OPG increase 15.9 (95% CI 11.0-22.9) and 6.38 (4.60-8.90), p = 0.0001, even after adjustment for standard predictors (3.16 (1.90-5.25) and 2.29 (1.53-3.44), p < 0.0001).
CONCLUSIONS


Circulating OPG holds long-term independent predictive ability for all-cause mortality and cardiovascular events in CAD participants. OPG levels were associated with diabetes, age, and female sex and statin treatment was associated with lower OPG levels in the absence of diabetes.",2020,"CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001.","['Participants were followed through public registers for 10 years', 'participants with diabetes', 'patients with stable coronary artery disease and its association with diabetes and statin treatment', 'CAD participants', 'CAD participants with diabetes', 'patients with stable coronary artery disease (CAD']","['statins', 'placebo']","['High OPG levels', 'Serum OPG levels', 'OPG levels', 'mortality and cardiovascular events', 'serum OPG levels', 'Serum osteoprotegerin']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0879435,"CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: mette.bjerre@clin.au.dk.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Department of Biostatistics, Institute of Public Health Research, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, S, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology, Rigshospitalet University of Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society/Division of Family Medicine, Karolinska Institute, Stockholm, Sweden; Department of Health and Social Sciences, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Holbæk Hospital, Holbæk, Denmark; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.03.030']
162,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS


Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED.
METHODS


This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment.
RESULTS


After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033).
CONCLUSION


Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009']
163,32315869,Quality of life after switching from well-controlled vitamin K antagonist to direct oral anticoagulant: Little to GAInN.,"BACKGROUND


Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) prevent thromboembolism in atrial fibrillation (AF). DOAC have a fixed dosing regimen and obviate INR monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA. However, some VKA users appreciate the monitoring. A high time in the therapeutic range (TTR) leads to a lower impact on QoL. We assessed the influence of switching from well-controlled VKA to a DOAC on QoL.
METHODS


In the GAInN study, 241 patients with AF, a TTR ≥ 70%, and neither bleeding nor thrombosis while on VKA were randomised to switching to DOAC (n = 121) or continuing VKA (n = 120). Health-related (SF-36) and anticoagulation-related QoL (PACT-Q) was assessed at baseline and after six and twelve months of follow-up.
RESULTS AND CONCLUSION


SF-36 development did not differ between groups. After one year, average PACT-Q Convenience improvement was 2.5 (0.3-4.7) higher on DOAC. DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp. (95%CI 1-43) in patients who scored <95/100 at baseline. The probability to meaningfully improve on PACT-Q Satisfaction was 12 pp. (95%CI 0-25) higher on DOAC. However, 5 (4.1%) and 4 (3.3%) DOAC users resumed VKA because of side-effects and patient preference. Switching from well-controlled VKA to DOAC for AF leads to a higher probability of improved PACT-Q convenience and satisfaction, but also to a higher risk of side-effects. Arguably only patients who are not satisfied with VKA should switch, because they have more to gain by switching.",2020,DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp.,"['241 patients with AF, a TTR\xa0≥\xa070%, and neither bleeding nor thrombosis while on VKA']","['vitamin K antagonist to direct oral anticoagulant', 'continuing VKA', 'Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA']","['Health-related (SF-36) and anticoagulation-related QoL (PACT-Q', 'average PACT-Q Convenience improvement', 'quality of life (QoL', 'Quality of life', 'probability to meaningfully improve on PACT-Q Satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",241.0,0.12822,DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp.,"[{'ForeName': 'Jasper H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands. Electronic address: j.h.a.van.miert@umcg.nl.'}, {'ForeName': 'Hilde A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands; Currently: Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Westerterp', 'Affiliation': 'Certe Thrombosis Service, Groningen, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.04.007']
164,32400000,"A Multicenter Randomized Three-Arm Phase II Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT in Patients with Unresectable Fibrolamellar Carcinoma.","LESSONS LEARNED


FLC is a complex cancer with many implicated oncogenic pathways. Single or dual targeting does not appear to alter the natural history of the cancer, and novel therapeutics are needed. Estrogen deprivation therapy with letrozole and leuprolide, alone or in combination with the mTOR inhibitor, everolimus, did not demonstrate clinical activity in advanced fibrolamellar carcinoma. The study drugs were well tolerated when administered as single agents or in combination in this patient population. This study demonstrates that, despite the rarity of FLC, multicenter therapeutic clinical trials are feasible and support the value of this consortium.
BACKGROUND


Fibrolamellar carcinoma (FLC) is an uncommon malignancy in young people and is sometimes associated with pregnancy and oral contraceptive use. Immunohistochemical staining and genetic profiling of FLC tumor specimens have revealed aromatase overexpression. The overexpression of mTOR and S6 kinase has been noted in 25% of FLC. On the basis of interaction between estrogen and the PI3K/Akt/mTOR pathway, we hypothesized that suppression of estrogen and mTOR signaling could have antineoplastic activity in FLC.
METHODS


Patients were randomized to arm A (everolimus), arm B (letrozole/leuprolide; estrogen deprivation therapy [EDT]), or arm C (everolimus/letrozole/leuprolide). Upon disease progression, patients in arm A or B could proceed to part 2 (everolimus/letrozole/leuprolide). The primary endpoint was progression-free survival (PFS) at 6 months (PFS6) assessed using a Simon's minimax two-stage design, hypothesizing an improvement in PFS6 from 40% to 64% with the study regimen.
RESULTS


Twenty-eight patients were enrolled. An unplanned analysis was performed because of perceived concern for lack of efficacy. Stable disease was observed in 9 of 26 evaluable patients (35%). PFS6 was 0%. Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort. Grade 3 adverse events in ≥10% of patients were nausea (11%), vomiting (11%), anemia (11%), elevated aspartate transaminase (AST; 32%), alanine transaminase (ALT; 36%), and alkaline phosphatase (14%). All 28 patients experienced an event for PFS outcome, and four deaths were due to disease progression.
CONCLUSION


Neither EDT nor mTOR inhibition improved outcomes in FLC. Other treatment strategies are needed.",2020,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","['Patients with Unresectable Fibrolamellar Carcinoma', 'advanced fibrolamellar carcinoma', 'Twenty-eight patients were enrolled', 'Patients']","['Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT', 'everolimus/letrozole/leuprolide', 'Estrogen deprivation therapy with letrozole and leuprolide, alone or in combination with the mTOR inhibitor, everolimus', 'everolimus), arm B (letrozole/leuprolide; estrogen deprivation therapy [EDT]), or arm C (everolimus/letrozole/leuprolide', 'FLC']","['Stable disease', 'overexpression of mTOR and S6 kinase', 'elevated aspartate transaminase', 'vomiting', 'anemia', 'nausea', 'Median overall survival (OS', 'Grade 3 adverse events', ""progression-free survival (PFS) at 6 months (PFS6) assessed using a Simon's minimax two-stage design, hypothesizing an improvement in PFS6"", 'alanine transaminase (ALT; 36%), and alkaline phosphatase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0073337', 'cui_str': 'Ribosomal Protein S6 Kinase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220989', 'cui_str': 'Acquired partial lipodystrophy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}]",28.0,0.0597627,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","[{'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'El Dika', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaQuaglia', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': ""O'Neill"", 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ly', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gordan', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0367']
165,32333853,Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial.,"BACKGROUND


We aimed to validate the Men Continue and HERDOO2 (HERDOO2), D-dimer, age, sex, hormonal therapy (DASH), and updated Vienna recurrent venous thromboembolism prediction models in a population composed entirely of first unprovoked pulmonary embolism, and to analyze the impact of the addition of the pulmonary vascular obstruction index (PVOI) on score accuracy.
METHODS


Analyses were based on the double-blind, randomized PADIS-PE trial, which included 371 unprovoked pulmonary embolism patients initially treated for 6 months, successively randomized to receive an additional 18 months of warfarin or placebo, and subsequently followed-up for 2 years.
RESULTS


The HERDOO2, DASH, and updated Vienna scores displayed C-statistics of 0.61 (95% CI 0.54-0.68), 0.60 (95% CI 0.53-0.66), and 0.58 (95% CI 0.51-0.66), respectively. Only the HERDOO2 score identified low recurrence risk patients (<3%/year) after anticoagulation was stopped. When added to either of the prediction models, PVOI measured at pulmonary embolism diagnosis, after 6 months of anticoagulation, or both, improved scores' C-statistics between +0.06 and +0.11 points and consistently led to identifying at least 50% of patients who experienced recurrence but in whom the scores would have indicated against extended anticoagulation.
CONCLUSIONS


In patients with a first unprovoked pulmonary embolism, the HERDOO2 score is able to identify patients with a low recurrence risk after treatment discontinuation. Addition of PVOI improves accuracy of all scores.
CLINICAL TRIALS REGISTRATION


URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.",2020,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.",['371 unprovoked pulmonary embolism patients initially treated during 6 months'],"['PVOI', 'warfarin or placebo']",['Venous Thromboembolism Recurrence Scores'],"[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",371.0,0.625721,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.","[{'ForeName': 'Leela', 'Initials': 'L', 'LastName': 'Raj', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Le Mao', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robin', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pernod', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bertoletti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jego', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, France.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Lemarié', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Leven', 'Affiliation': 'Service de Cardiologie and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': ""Service d'Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Planquette', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Le Roux', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Slaun', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Nonent', 'Affiliation': 'Service de Radiologie, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département Thoracique, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lacut', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Solen', 'Initials': 'S', 'LastName': 'Mélac', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Guégan', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leroyer', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France. Electronic address: francis.couturaud@chu-brest.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.03.040']
166,32305456,Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.,"Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.",2020,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","['perinatal women seeking mental health treatment', 'women who seek mental health treatment, mental health clinics', 'perinatal women', 'women and their developing fetus/infant']","['Intimate partner victimization (IPV', 'Computerized intervention']",['adverse physical and emotional outcomes'],"[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",186.0,0.0511695,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Akron, Akron, OH 44325-4301, USA. Electronic address: johnsod@uakron.edu.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, MD, USA; School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, Obstetrics & Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ""Division of Research, Women and Infant's Hospital, Providence, RI, USA.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ""Department of Medicine, Women and Infant's Hospital, Providence, RI, USA; Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106011']
167,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE


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


Controlled laboratory study.
PARTICIPANTS


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


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


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


Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
168,32325419,"Efficacy and safety of the therapeutic cancer vaccine tecemotide (L-BLP25) in early breast cancer: Results from a prospective, randomised, neoadjuvant phase II study (ABCSG 34).","BACKGROUND


Immune-based strategies represent a promising approach in breast cancer (BC) treatment. The glycoprotein mucin-1 (MUC-1) is overexpressed in more than 90% of BC patients, and is targeted by the cancer vaccine tecemotide. We have investigated the efficacy and safety of tecemotide when added to neoadjuvant standard-of-care (SoC) treatment in early BC patients.
PATIENTS AND METHODS


A total of 400 patients with HER2-early BC were recruited into this prospective, multicentre, randomised 2-arm academic phase II trial. Patients received preoperative SoC treatment (chemotherapy or endocrine therapy) with or without tecemotide. Postmenopausal women with oestrogen receptor (ER)+++, or ER++ and Ki67 < 14%, and G1,2 tumours ('luminal A' tumours) received 6 months of letrozole. Postmenopausal patients with triple-negative, ER-/+/++ and Ki67 ≥ 14%, and with G3 tumours, as well as premenopausal patients, received four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel. Primary end-point was residual cancer burden (RCB; 0/I versus II/III) at surgery. Secondary end-points included pathological complete response (pCR), safety, and quality of life.
FINDINGS


We observed no significant difference in RCB 0/I rates between patients with (36.4%) and without (31.9%) tecemotide in the overall study population (p = 0.40) nor in endocrine and chemotherapy-treated subgroups (25.0% versus 13.3%, p = 0.17; 39.6% versus 37.8%, p = 0.75, respectively). The addition of tecemotide did not affect overall pCR rates (22.5% versus 17.4%, p = 0.23), MUC-1 expression, or tumour-infiltrating lymphocytes content. Tecemotide did not increase toxicity when compared to SoC therapy alone.
INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.",2020,"INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.","['early BC patients', 'Postmenopausal patients with triple-negative, ER-/+/++ and Ki67\xa0≥\xa014%, and with G3 tumours, as well as premenopausal patients', 'early breast cancer', 'patients receiving standard neoadjuvant therapy', '400 patients with HER2-early BC', 'Postmenopausal women with oestrogen receptor (ER)+++, or ER++ and Ki67']","['letrozole', 'preoperative SoC treatment (chemotherapy or endocrine therapy) with or without tecemotide', 'epirubicin/cyclophosphamide plus four cycles of docetaxel', 'therapeutic cancer vaccine tecemotide (L-BLP25']","['pathological complete response (pCR), safety, and quality of life', 'overall pCR rates', 'RCB 0/I rates', 'residual cancer burden (RCB', 'MUC-1 expression, or tumour-infiltrating lymphocytes\xa0content', 'RCB or pCR rates', 'toxicity', 'Efficacy and safety']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C2724205', 'cui_str': '+++'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Cancer'}, {'cui': 'C1832016', 'cui_str': 'L-BLP25'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",400.0,0.0652501,"INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.","[{'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria. Electronic address: christian.singer@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfeiler', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hubalek', 'Affiliation': 'Breast Center Schwaz, BKH Schwaz, Schwaz, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bartsch', 'Affiliation': 'Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Stöger', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal Germany, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Muy-Kheng', 'Initials': 'MK', 'LastName': 'Maria Tea', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breastcenter Carinthia, St. Veit, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sevelda', 'Affiliation': 'Karl Landsteiner Institute for Gynecologic Oncology and Senology, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breastcenter St. Anna, Lucerne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Jakesz', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tinchon', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frantal', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group (ABCSG), Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.018']
169,32196749,"A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris ®  ) in healthy male subjects.","OBJECTIVES


ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double-blind, three-arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizumab reference product (RP) in healthy adult male subjects.
METHODS


Eligible subjects aged 18-45 years were randomized to receive a 300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU). Primary PK endpoint was area under the total serum concentration-time curve from 0 to infinity (AUC 0-∞  ); primary PD endpoint was area between the effect curve (ABEC) of CH50-time data.
RESULTS


The geometric mean of PK and PD parameters were similar between ABP 959 versus eculizumab US and eculizumab EU; PK and PD similarity was established based on 90% confidence intervals of the geometric mean ratio being within prespecified equivalence margin of 0.8 and 1.25. The incidence of treatment-emergent adverse events was similar across groups. The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
CONCLUSIONS


This study demonstrated PK and PD similarity of ABP 959 to eculizumab RP; safety and immunogenicity profiles were also similar.",2020,"The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
","['healthy adult male subjects', 'Healthy Male Subjects', 'Eligible subjects aged 18-45 years']","['300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU', 'ABP 959 and Eculizumab (Soliris ®  ']","['geometric mean of PK and PD parameters', 'incidence of treatment-emergent adverse events', 'area under the total serum concentration-time curve', 'incidence of binding anti-drug antibodies', 'pharmacokinetic (PK) and pharmacodynamic (PD) similarity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C1744173', 'cui_str': 'Soliris'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.331056,"The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Mytych', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",European journal of haematology,['10.1111/ejh.13411']
170,32232363,Acute Effects of Glucagon on Reproductive Hormone Secretion in Healthy Men.,"CONTEXT


Glucagon increases energy expenditure; consequently, glucagon receptor agonists are in development for the treatment of obesity. Obesity negatively affects the reproductive axis, and hypogonadism itself can exacerbate weight gain. Therefore, knowledge of the effects of glucagon receptor agonism on reproductive hormones is important for developing therapeutics for obesity; but reports in the literature about the effects of glucagon receptor agonism on the reproductive axis are conflicting.
OBJECTIVE


The objective of this work is to investigate the effect of glucagon administration on reproductive hormone secretion in healthy young men.
DESIGN


A single-blinded, randomized, placebo-controlled crossover study was conducted.
SETTING


The setting of this study was the Clinical Research Facility, Imperial College Healthcare NHS Trust.
PARTICIPANTS


Eighteen healthy eugonadal men (mean ± SEM: age 25.1 ± 1.0 years; body mass index 22.5 ± 0.4 kg/m2; testosterone 21.2 ± 1.2 nmol/L) participated in this study.
INTERVENTION


An 8-hour intravenous infusion of 2 pmol/kg/min glucagon or rate-matched vehicle infusion was administered.
MAIN OUTCOME MEASURES


Luteinizing hormone (LH) pulsatility; LH, follicle-stimulating hormone (FSH), and testosterone levels were measured.
RESULTS


Although glucagon administration induced metabolic effects (insulin area under the curve: vehicle 1065 ± 292 min.µU/mL vs glucagon 2098 ± 358 min.µU/mL, P < .001), it did not affect LH pulsatility (number of LH pulses/500 min: vehicle 4.7 ± 0.4, glucagon 4.2 ± 0.4, P = .22). Additionally, there were no significant differences in circulating LH, FSH, or testosterone levels during glucagon administration compared with vehicle administration.
CONCLUSIONS


Acute administration of a metabolically active dose of glucagon does not alter reproductive hormone secretion in healthy men. These data are important for the continued development of glucagon-based treatments for obesity.",2020,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","['Healthy Men', 'Eighteen healthy eugonadal men (mean±SEM', 'healthy men', 'healthy young men']","['placebo', 'glucagon receptor agonism', 'glucagon administration', '2pmol/kg/min glucagon or rate-matched vehicle infusion', 'Glucagon', 'glucagon']","['circulating LH, FSH or testosterone levels', 'LH pulsatility', 'Reproductive Hormone Secretion', 'metabolic effects', 'reproductive hormone secretion', 'Luteinizing hormone (LH) pulsatility; LH, follicle stimulating hormone (FSH) and testosterone levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",18.0,0.287042,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Yoshibye', 'Initials': 'Y', 'LastName': 'Crustna', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pratibha C', 'Initials': 'PC', 'LastName': 'Machenahalli', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Starikova', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Risheka', 'Initials': 'R', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pacuszka', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Minnion', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tharakan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veldhuis', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa164']
171,32251871,"Public opinion and legislations related to brain death, circulatory death and organ donation.","BACKGROUND


It is poorly understood how public perception of the difference between brain death and circulatory death may influence attitudes towards organ donation. We investigated the public opinion on brain death versus circulatory death and documented inconsistencies in the legislations of countries with different cultural and socioeconomic backgrounds.
METHODS


Using a crowdsourcing approach, we randomized 1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death. Further, we sampled guidelines from 24 countries and 5 continents.
RESULTS


Of all participants, 73% stated they would be willing to donate all organs, while 16% would want to donate some of their organs. To increase the rate of donations, 47% would agree with organ donation without family consent as the default. Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11). However, participants exposed to ""circulatory death"" were more certain that the patient was truly dead (87.9% ± 19.7%) than participants exposed to ""brain death"" (84.1% ± 22.7%; Cohen's d 0.18; p = 0:004). Sampling of guidelines revealed large differences between countries regarding procedures required to confirm brain death and circulatory death, respectively.
CONCLUSIONS


Implementation of organ donation after circulatory death is unlikely to negatively influence the willingness to donate organs, but legislation is still brain death-based in most countries. The time seems ripe to increase the rate of circulatory death-based organ donation.",2020,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","['24 countries and 5 continents', '1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death']",[],"['rate of circulatory death-based organ donation', 'rate of donations', 'brain death and circulatory death', 'circulatory death']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}]",1072.0,0.124868,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","[{'ForeName': 'Marwan H', 'Initials': 'MH', 'LastName': 'Othman', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Biomedical Engineering, University at Buffalo, State University of New York, NY, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kondziella', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: daniel.kondziella@regionh.dk.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116800']
172,28278602,Components Analyses of a School-Based Cognitive Behavioral Treatment for Youth Depression.,"The current study sought to build upon research on cognitive behavioral therapy (CBT) as the first-line treatment for depressed youth by investigating the effects of the various components of a CBT treatment on changes in depressive symptoms in young female participants. Female participants 9-14 years of age (n = 40; M age = 10.58 years) with a diagnosis of a depressive disorder from the CBT-only treatment condition of a larger randomized clinical trial were included in the current study. Participants engaged in a 20-session, 11-week, school-based CBT group intervention (ACTION Treatment; Stark et al., 2006). Depressive symptoms were assessed pre- and posttreatment, and intervention components were coded based on review of audio recordings of treatment sessions. Data were examined using two-level mixed-effects models using hierarchical linear modeling with full maximum likelihood estimation. Results indicated that higher quality behavioral intervention components were associated with greater improvement in posttreatment depression scores, higher quality cognitive intervention components were marginally associated with worsening posttreatment depression scores, and relational intervention components were not associated with depression outcome. Age significantly moderated the relationships between intervention components and depression outcome, with younger female participants benefiting most from higher quality behavioral and relational intervention components. These findings provide preliminary evidence about the differential impact of CBT components on depression treatment outcome for young female participants, with consideration of age as a moderator. This study highlights the importance of continuing to dismantle CBT treatment components for youth depression, as such findings can be used to design more potent, developmentally tailored interventions.",2019,"Results indicated that higher quality behavioral intervention components were associated with greater improvement in posttreatment depression scores, higher quality cognitive intervention components were marginally associated with worsening posttreatment depression scores, and relational intervention components were not associated with depression outcome.","['Youth Depression', '10.58\xa0years) with a diagnosis of a depressive disorder from the CBT-only treatment condition of a larger randomized clinical trial were included in the current study', 'Female participants 9-14\xa0years of age (n\xa0=\xa040; M age\xa0', 'young female participants']","['cognitive behavioral therapy (CBT', 'CBT treatment', 'School-Based Cognitive Behavioral Treatment', 'CBT components']","['depressive symptoms', 'Depressive symptoms', 'posttreatment depression scores, higher quality cognitive intervention components']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",,0.0226359,"Results indicated that higher quality behavioral intervention components were associated with greater improvement in posttreatment depression scores, higher quality cognitive intervention components were marginally associated with worsening posttreatment depression scores, and relational intervention components were not associated with depression outcome.","[{'ForeName': 'Prerna G', 'Initials': 'PG', 'LastName': 'Arora', 'Affiliation': 'a Department of Psychology , Pace University.'}, {'ForeName': 'Courtney N', 'Initials': 'CN', 'LastName': 'Baker', 'Affiliation': 'c Department of Psychology , Tulane University.'}, {'ForeName': 'Lauren Krumholz', 'Initials': 'LK', 'LastName': 'Marchette', 'Affiliation': 'd Cambridge Health Alliance , Harvard Medical School.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Stark', 'Affiliation': 'e Department of Educational Psychology , University of Texas Austin.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2017.1280800']
173,28318309,The Moderating Effect of Risk Exposure on an Efficacious Intervention for Maltreated Children.,"The current study extends research on the impact of the Fostering Healthy Futures program (Taussig & Culhane, 2010), a 9-month mentoring and skills group preventive intervention for maltreated children, by examining whether the effect of Fostering Healthy Futures is moderated by children's baseline risk exposure (i.e., number of adverse childhood experiences). Participants included 156 racially and ethnically diverse children (ages 9-11, 50.7% female) recently placed in foster care due to maltreatment who were randomized to intervention or control conditions. Baseline and 6-month postintervention measures included a multi-informant index of mental health functioning and youth-reported symptoms of posttraumatic stress, dissociation, coping skills, social-acceptance, global self-worth, social support, and quality of life. A previously published, empirically derived risk index was used to assess level of exposure to 6 adverse childhood experiences (i.e., physical abuse, sexual abuse, removal from a single parent household, high level of exposure to community violence, and high numbers of caregiver and school transitions). Significant Intervention × Risk interactions were observed in regression models predicting 6-month postintervention symptoms of posttraumatic stress (β = .38, p < .001) and dissociation (β = .30, p < .01). Among children with low to moderate levels of risk, intervention participants evidenced fewer symptoms, whereas intervention participants with high levels of risk did not differ from the control group. The results of this study suggest that maltreated children exposed to high numbers of adverse childhood experiences may not experience the same reduction in trauma symptoms postintervention relative to children exposed to fewer adversities.",2019,"Significant Intervention × Risk interactions were observed in regression models predicting 6-month postintervention symptoms of posttraumatic stress (β = .38, p < .001) and dissociation (β = .30,","['Maltreated Children', 'Participants included 156 racially and ethnically diverse children (ages 9-11, 50.7% female) recently placed in foster care due to maltreatment who were randomized to']","['intervention or control conditions', 'mentoring and skills group preventive intervention']","['multi-informant index of mental health functioning and youth-reported symptoms of posttraumatic stress, dissociation, coping skills, social-acceptance, global self-worth, social support, and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037438'}, {'cui': 'C0034380'}]",,0.0394808,"Significant Intervention × Risk interactions were observed in regression models predicting 6-month postintervention symptoms of posttraumatic stress (β = .38, p < .001) and dissociation (β = .30,","[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'a Department of Family Social Science , University of Minnesota.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Taussig', 'Affiliation': 'b Kempe Center for the Prevention and Treatment of Child Abuse and Neglect , University of Colorado School of Medicine.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2017.1295379']
174,28715242,Not All Masks Are Created Equal: Masking Success in Clinical Trials of Children and Adolescents.,"The current study assessed the success of masking omega-3 (Ω3) and psychotherapy in clinical trials of youth with depression or bipolar spectrum disorder. Participants were youth ages 7-14 with DSM-IV-TR diagnosed depressive (n = 72) or bipolar spectrum (n = 23) disorders. Inclusion diagnoses were depressive disorder, cyclothymic disorder, or bipolar disorder not otherwise specified. Exclusion diagnoses included bipolar I or II disorder, chronic medical condition or autism. Youth participated in 2 × 2 randomized controlled trials, in which they received Ω3 or placebo (PBO) and psychoeducational psychotherapy (PEP) or active monitoring (AM). Participants and study staff (including independent interviewers) were masked to Ω3/PBO allocation. Besides the masked independent interviewers, one coprincipal investigator (Co-PI) was fully masked to both conditions and completed all consensus conference ratings postrandomization. At the endpoint assessment or last completed interview, interviewers and the masked Co-PI guessed whether each child was assigned to Ω3 or PBO and to PEP or AM. Masking failure was calculated using the degree of correct guesses above chance level using binomial tests across all participants for Ω3 versus PBO and PEP versus AM. For all guessers, Ω3 allocation was guessed correctly approximately half the time (50%-52.5%). Rates of correct guessing were higher for PEP, but only the interviewer guesses were correct significantly more often (58.5%-68.7%) than chance. Reporting of masking success should be an essential element of RCTs. Psychotherapy is generally more difficult to mask, but with attentive masking procedures reasonable masking can be achieved.",2019,"Rates of correct guessing were higher for PEP, but only the interviewer guesses were correct significantly more often (58.5%-68.7%) than chance.","['youth with depression or bipolar spectrum disorder', 'Exclusion diagnoses included bipolar I or II disorder, chronic medical condition or autism', 'Inclusion diagnoses were depressive disorder, cyclothymic disorder, or bipolar disorder not otherwise specified', 'Children and Adolescents', 'Participants were youth ages 7-14 with DSM-IV-TR diagnosed depressive (n\xa0=\xa072) or bipolar spectrum (n\xa0=\xa023) disorders']","['masking omega-3 (Ω3) and psychotherapy', 'Ω3 or placebo (PBO) and psychoeducational psychotherapy (PEP) or active monitoring (AM', 'Psychotherapy']","['Rates of correct guessing', 'Masking failure']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0010598', 'cui_str': 'Cyclothymic Personality'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.120081,"Rates of correct guessing were higher for PEP, but only the interviewer guesses were correct significantly more often (58.5%-68.7%) than chance.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'a Department of Psychology , The University of Notre Dame.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Black', 'Affiliation': 'b Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'b Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Fristad', 'Affiliation': 'b Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2017.1342547']
175,31148589,Dietary micronutrient intakes among women of reproductive age in Mumbai slums.,"OBJECTIVES


To (1) describe micronutrient intakes among women of reproductive age living in Mumbai slums; (2) assess the adequacy of these intakes compared with reference values; (3) identify important dietary sources of micronutrients.
SUBJECTS/METHODS


Participants were 6426 non-pregnant women aged 16-39 years, registered in a randomised controlled trial of a food-based intervention set in the Bandra, Khar and Andheri areas of Mumbai, India. Cross-sectional quantified food frequency questionnaire (FFQ) data were collected. Vitamin (n = 9) and mineral (n = 6) intakes were calculated and analysed in relation to dietary reference values (DRVs). Important dietary sources were identified for each micronutrient.
RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI). Intakes of calcium, iron, vitamin A and folate were furthest from the RNI. For seven of the micronutrients, over half of the women had intakes below the lower reference nutrient intake (LRNI); this figure was over 75% for calcium and riboflavin. The majority of women (93%) had intakes below the EAR for 5 or more micronutrients, and 64% for 10 or more. Adolescents had lower intakes than women aged >19 years. Less than 1% of adult women and no adolescents met the EAR for all micronutrients. Animal source foods and micronutrient-rich fruit and vegetables were consumed infrequently.
CONCLUSIONS


These women had low intakes of multiple micronutrients, increasing their risk of insufficiency. There is a need to determine the factors causing poor intakes, to direct interventions that improve diet quality and nutritional sufficiency.",2019,"RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","['women of reproductive age living in Mumbai slums', 'Adolescents had lower intakes than women aged >19 years', 'women of reproductive age in Mumbai slums', 'Participants were 6426 non-pregnant women aged 16-39 years']","['Vitamin', 'riboflavin']","['Intakes of calcium, iron, vitamin A and folate', 'Cross-sectional quantified food frequency questionnaire (FFQ) data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",6426.0,0.0580757,"RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Nunn', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Kehoe', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK. sk@mrc.soton.ac.uk.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Chopra', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Sirazul A', 'Initials': 'SA', 'LastName': 'Sahariah', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Gravio', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Patsy J', 'Initials': 'PJ', 'LastName': 'Coakley', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Cox', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Harshad', 'Initials': 'H', 'LastName': 'Sane', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Shivshankaran', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Marley-Zagar', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Barrie M', 'Initials': 'BM', 'LastName': 'Margetts', 'Affiliation': 'Public Health Nutrition, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Jackson', 'Affiliation': 'National Institute for Health Research, Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'Ramesh D', 'Initials': 'RD', 'LastName': 'Potdar', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Fall', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0429-6']
176,32289518,Effects of supervised high-intensity resistance and impact training or machine-based isometric training on regional bone geometry and strength in middle-aged and older men with low bone mass: The LIFTMOR-M semi-randomised controlled trial.,"INTRODUCTION


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


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


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


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


Findings indicate that supervised HiRIT provides a positive stimulus to cortical bone at the medial FN compared with supervised IAC exercise, and both HiRIT and IAC preserve bone strength at the distal tibia and distal radius. These effects may translate into a reduced risk of lower and upper extremity fracture in middle-aged and older men with low bone mass.",2020,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","['middle-aged and older men with osteopenia and osteoporosis', 'Eligible participants', 'middle-aged and older men with low bone mass', 'Ninety-three men (67.1\u202f±\u202f7.5\u202fyrs, 175.2\u202f±\u202f6.7\u202fcm, 82.1\u202f±\u202f11.6\u202fkg, 26.7\u202f±\u202f3.5\u202fkg/m 2 ) with lower than average aBMD (LS T-score -0.06\u202f±\u202f1.04, FN T-score -1.58\u202f±\u202f0.58, TH T-score -1.00\u202f±\u202f0.58) were recruited, and designated CON (n\u202f=\u202f26) or randomised to', 'men', 'Generally-healthy men (≥45\u202fyears), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community', 'middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures']","['IAC', 'high-intensity exercise programs', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'supervised high-intensity resistance and impact training or machine-based isometric training', 'HiRIT', 'twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training']","['HiRIT maintained distal tibia trabecular area', 'pQCT-derived bone outcome', 'femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments', 'Total FN cortical thickness', 'Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index', 'DXA scans (Medix DR, Medilink, France', 'HiRIT and IAC maintained distal radius total BMC', 'HiRIT and IAC maintained distal radius total bone strength index', 'efficacy and safety', 'regional bone geometry and strength', 'medial FN cortical thickness', 'HiRIT reduced proximal radius cortical area']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C5191362', 'cui_str': '1.04'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0588205', 'cui_str': 'Bone structure of proximal radius'}]",93.0,0.0493938,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","[{'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia; The Bone Clinic, Brisbane, Queensland, Australia. Electronic address: b.beck@griffith.edu.au.'}]",Bone,['10.1016/j.bone.2020.115362']
177,32305825,Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery.,"OBJECTIVES


Pregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS).
PATIENTS AND METHODS


30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery.
RESULTS


In the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group.
CONCLUSION


Pregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.",2020,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","['patients with relapsing remitting multiple sclerosis (RRMS', '30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017', 'women with multiple sclerosis (MS']",['pregnancy and exclusive breastfeeding'],"['total number of relapses', 'Expanded Disability Status Scale (EDSS', 'relapse rate and disability', 'mean EDSS', 'multiple sclerosis relapse rate and degree of disability', 'rate of relapse and degree of disability', 'mean number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0139494,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Abdorreza Naser', 'Initials': 'AN', 'LastName': 'Moghadasi', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.ghaffari@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105829']
178,32328440,Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial.,"Background


Migration is a challenging life transition that may be a source of various problems related to well-being and mental health. However, the psychological adaptation of migrants may be potentially facilitated by social self-efficacy-the beliefs in one's ability to initiate and maintain interpersonal relationships. Previous research suggests that social self-efficacy is positively related to adjustment and negatively related to loneliness, depression, and psychological distress. Research also confirms that self-efficacy beliefs can be effectively enhanced using Internet-based interventions. These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to sources of self-efficacy beliefs: mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. Users complete increasingly challenging tasks that encourage them to interact with their environment. The aim of this trial was to investigate the efficacy of the New in Town intervention.
Methods


The efficacy of the New in Town intervention will be tested in a two-arm randomized controlled trial with a waitlist control group. Social self-efficacy will be the primary outcome. Secondary outcomes will include loneliness, perceived social support, and satisfaction with life. Additionally, we will measure user experience among participants allocated to the experimental group. We aim to recruit a total of  N  = 280 participants aged at least 18 years who have changed their place of residence in the last 6 months and have an Internet connection. Participants will be assessed at baseline, 3-week post-test, and 8-week follow-up.
Discussion


The trial will provide insights into the efficacy of Internet-based self-help interventions in increasing social self-efficacy. Given that the intervention works, New in Town could provide an easily accessible support option for internal migrants in Poland.
Trial registration


The trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.",2020,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.",['total of  N \u202f=\u202f280 participants aged at least 18\u202fyears who have changed their place of residence in the last 6\u202fmonths and have an Internet connection'],"['Internet-based self-help intervention', 'Internet-based self-help interventions']","['Social self-efficacy', 'loneliness, perceived social support, and satisfaction with life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",280.0,0.0703208,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rogala', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Szczepaniak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100322']
179,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440']
180,27105332,Predicting Therapeutic Effects of Psychodiagnostic Assessment Among Children and Adolescents Participating in Randomized Controlled Trials.,"This study explored predictors of improvement after completing a psychodiagnostic screening assessment but before randomization among youth who participated in two pilot randomized controlled trials of omega-3 supplementation and Individual-Family Psychoeducational Psychotherapy (PEP). Ninety-five youth (56.8% male, 61.1% White) ages 7-14 with mood disorders completed screening and baseline assessments (including Clinical Global Impressions-Improvement [CGI-I], Children's Depression Rating Scale-Revised, Young Mania Rating Scale), then were randomized into a 12-week trial of omega-3, PEP, their combination, or placebo. Between screening and randomization, 35.8% minimally improved (CGI-I = 3), 12.6% much improved (CGI-I < 3), totaling 48.4% improved. Caregiver postsecondary education (p = .018), absence of attention-deficit/hyperactivity disorder (p = .027), and lower screen depression severity (p = .034) were associated with CGI-I. Caregiver postsecondary education (p = .020) and absence of a disruptive behavior diagnosis (p = .038) were associated with depression severity improvement. Prerandomization improvement moderated treatment outcomes: Among youth who improved prerandomization, those who received PEP (alone or with omega-3) had more favorable placebo-controlled depression trajectories due to a lack of placebo response. This open-label trial of psychodiagnostic assessment provides suggestive evidence that psychodiagnostic assessment is beneficial, especially for those with depression and without externalizing disorders. Prerandomization improvement is associated with better placebo-controlled treatment response. Future research should test alternative hypotheses for change and determine if less intensive (shorter and/or automated) assessments would provide comparable results.",2019,"Between screening and randomization, 35.8% minimally improved (CGI-I = 3), 12.6% much improved (CGI-I < 3), totaling 48.4% improved.","[""Ninety-five youth (56.8% male, 61.1% White) ages 7-14 with mood disorders completed screening and baseline assessments (including Clinical Global Impressions-Improvement [CGI-I], Children's Depression Rating Scale-Revised, Young Mania Rating Scale"", 'Children and Adolescents']","['omega-3, PEP, their combination, or placebo', 'Psychodiagnostic Assessment', 'omega-3 supplementation and Individual-Family Psychoeducational Psychotherapy (PEP', 'psychodiagnostic screening assessment', 'PEP (alone or with omega-3']","['screen depression severity', 'absence of a disruptive behavior diagnosis', 'absence of attention-deficit/hyperactivity disorder']","[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",,0.0942568,"Between screening and randomization, 35.8% minimally improved (CGI-I = 3), 12.6% much improved (CGI-I < 3), totaling 48.4% improved.","[{'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}, {'ForeName': 'Molly R', 'Initials': 'MR', 'LastName': 'Meers', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Vesco', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}, {'ForeName': 'Adina M', 'Initials': 'AM', 'LastName': 'Seidenfeld', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Fristad', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1146992']
181,27310418,"Cognitive-Behavioral Therapy Plus Healthy Lifestyle Enhancement for Depressed, Overweight/Obese Adolescents: Results of a Pilot Trial.","The objective of this article was to conduct a treatment development study to examine the feasibility, acceptability, and preliminary efficacy of treating depressed, overweight/obese adolescents using both an exercise regimen and a Cognitive Behavioral Therapy (CBT) protocol modified to address aspects of healthy living and nutrition (CBT plus healthy lifestyle; CBT-HL). A randomized controlled repeated measures design was used to test the hypothesis that CBT-HL would lead to greater reductions in depressed mood and weight compared to CBT for Depression Only (CBT). Participants (n=33; 24 in CBT-HL condition) included 33 adolescents (median age 15, 73% female, 61% white, 36% Hispanic) who met DSM-IV criteria for Current Major Depressive Episode (MDE) and had BMI ≥ 85th percentile. CBT-HL was found to be feasible to implement with most adolescents. Both conditions resulted in improvement in depressed mood. The CBT-HL protocol was more effective in stabilizing weight status as assessed by BMI. Percent time spent in MVPA was increased at 12 weeks for adolescents in CBT-HL compared to those in CBT. The CBT-HL protocol was acceptable to most, but not all, adolescents, and resulted in an improvement in depressed mood as well as stabilization of weight status. A larger study to test efficacy and moderators of treatment outcome is necessary to better understand which adolescents would benefit most from the increased demands of exercise and adhering to nutrition recommendations in addition to standard CBT for depression. Revisions to the treatment protocol to support weight loss, not just stabilization, are also suggested.",2019,Percent time spent in MVPA was increased at 12 weeks for adolescents in CBT-HL compared to those in CBT.,"['healthy living and nutrition (CBT plus healthy lifestyle; CBT-HL', 'Participants (n=33; 24 in CBT-HL condition) included 33 adolescents (median age 15, 73% female, 61% white, 36% Hispanic) who met DSM-IV criteria for Current Major Depressive Episode (MDE) and had BMI ≥ 85th percentile', 'Depressed, Overweight/Obese Adolescents']","['Cognitive-Behavioral Therapy Plus Healthy Lifestyle Enhancement', 'exercise regimen and a Cognitive Behavioral Therapy (CBT) protocol']","['Percent time spent in MVPA', 'stabilizing weight status']","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.0217176,Percent time spent in MVPA was increased at 12 weeks for adolescents in CBT-HL compared to those in CBT.,"[{'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'a Department of Psychiatry and Human Behavior , Warren Alpert Medical School of Brown University; Rhode Island Hospital.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jandasek', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Warren Alpert Medical School of Brown University, and Rhode Island Hospital.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Warren Alpert Medical School of Brown University, and Rhode Island Hospital.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Seaboyer', 'Affiliation': 'd Rhode Island Hospital.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'e Department of Psychiatry and Human Behavior , Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'e Department of Psychiatry and Human Behavior , Warren Alpert Medical School of Brown University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1163705']
182,27532425,Pilot Randomized Controlled Trial of LEAP: A Selective Preventive Intervention to Reduce Adolescents' Perceived Burdensomeness.,"This research draws upon the interpersonal-psychological theory of suicide in the development of the LEAP intervention, a web-based selective preventive suicide intervention targeting cognitions of perceived burdensomeness toward others. The pilot randomized controlled trial consisted of 80 adolescents (68.8% female, 65.8% Hispanic) 13-19 of age years who were randomly assigned to either the LEAP intervention or a psychoeducational control condition. Participants completed baseline, posttreatment, and 6-week follow-up assessments. All participants reported high levels of satisfaction with the program. Findings on outcome variables differed across intent-to-treat analyses and treatment completer analyses. Intent-to-treat analysis yielded no significant between-condition differences in perceived burdensomeness at posttreatment or follow-up. Treatment completer analyses revealed significant between-condition differences on outcome variables such that participants who completed the LEAP intervention showed significantly lower perceived burdensomeness scores at postintervention and significantly lower perceived burdensomeness, thwarted belongingness, and depressive symptom scores at follow-up as compared to participants in the control condition. No significant differences in suicidal ideation were found between conditions. These findings support the promise of the LEAP intervention as a brief, web-based selective preventive intervention for reducing perceived burdensomeness among adolescents who complete the intervention. This study provides evidence that perceived burdensomeness can be modified via a psychosocial intervention. Future research is needed to identify ways to enhance adolescent engagement with and completion of the intervention.",2019,Intent-to-treat analysis yielded no significant between-condition differences in perceived burdensomeness at posttreatment or follow-up.,"['80 adolescents (68.8% female, 65.8% Hispanic) 13-19\xa0of age years']","['Selective Preventive Intervention', 'LEAP', 'LEAP intervention', 'LEAP intervention or a psychoeducational control condition']","['burdensomeness, thwarted belongingness, and depressive symptom scores', 'suicidal ideation', 'burdensomeness scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",80.0,0.0737855,Intent-to-treat analysis yielded no significant between-condition differences in perceived burdensomeness at posttreatment or follow-up.,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Hill', 'Affiliation': 'a Department of Psychology , Florida International University.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Pettit', 'Affiliation': 'a Department of Psychology , Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1188705']
183,27646462,The Depression Prevention Initiative: Impact on Adolescent Internalizing and Externalizing Symptoms in a Randomized Trial.,"This randomized controlled trial examined the longitudinal effects of two school-based indicated depression prevention programs on adolescents' internalizing and externalizing symptoms, as measured by adolescents, their parents, and their teachers. One hundred eighty-six adolescents participated in this study. The average age was 14.01 (SD = 1.22) years, and the sample was 66.7% female. One third of the sample belonged to a racial minority. Youth received either Interpersonal Psychotherapy-Adolescent Skills Training or group counseling. Symptoms were assessed using adolescent, parent, and teacher reports on the Achenbach System of Empirically Based Assessment at baseline, postintervention, and 6-month follow-up. Adolescents reported the most robust effects in favor of Interpersonal Psychotherapy-Adolescent Skills Training. Adolescents in Interpersonal Psychotherapy-Adolescent Skills Training reported significantly greater reductions in internalizing symptoms through the 6-month follow-up and significantly greater reductions in externalizing symptoms during the intervention as compared to group counseling. Less robust effects were found when examining parent and teacher reports, although there was evidence of significant within-group change in parent- and teacher-reported internalizing symptoms for both interventions and significant between-group differences in teacher-reported externalizing symptoms. This study provides additional evidence supporting the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training as a depression prevention program for adolescents. Interpersonal Psychotherapy-Adolescent Skills Training appears to have fast-acting effects on broadband internalizing and externalizing symptoms as reported by adolescents. This suggests that Interpersonal Psychotherapy-Adolescent Skills Training may serve as a transdiagnostic preventive intervention. Moreover, given the disparate reports of adolescents, parents, and teachers, this study demonstrates the significance of collecting information from multiple sources when possible.",2019,Adolescents in Interpersonal Psychotherapy-Adolescent Skills Training reported significantly greater reductions in internalizing symptoms through the 6-month follow-up and significantly greater reductions in externalizing symptoms during the intervention as compared to group counseling.,"['One hundred eighty-six adolescents participated in this study', ""adolescents' internalizing and externalizing symptoms, as measured by adolescents, their parents, and their teachers"", 'adolescents']","['school-based indicated depression prevention programs', 'Interpersonal Psychotherapy-Adolescent Skills Training', 'Interpersonal Psychotherapy-Adolescent Skills Training or group counseling']","['broadband internalizing and externalizing symptoms', 'parent- and teacher-reported internalizing symptoms', 'internalizing symptoms', 'externalizing symptoms']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",186.0,0.0333161,Adolescents in Interpersonal Psychotherapy-Adolescent Skills Training reported significantly greater reductions in internalizing symptoms through the 6-month follow-up and significantly greater reductions in externalizing symptoms during the intervention as compared to group counseling.,"[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Benas', 'Affiliation': 'a Graduate School of Applied and Professional Psychology, Rutgers University.'}, {'ForeName': 'Alyssa E', 'Initials': 'AE', 'LastName': 'McCarthy', 'Affiliation': 'a Graduate School of Applied and Professional Psychology, Rutgers University.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Haimm', 'Affiliation': 'a Graduate School of Applied and Professional Psychology, Rutgers University.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'a Graduate School of Applied and Professional Psychology, Rutgers University.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'b Department of Mathematics, West Chester University.'}, {'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': 'a Graduate School of Applied and Professional Psychology, Rutgers University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1197839']
184,30903287,Improvement in depression with oestrogen treatment in women with schizophrenia.,"Women with schizophrenia are often noted to suffer with comorbid depression. Many studies have shown associations between fluctuating oestrogen levels in the brain and mental illness. This study investigates the effect of oestradiol treatment on comorbid depressive symptoms in women with schizophrenia. This study is an 8-week, three-arm, double-blind, randomised-controlled trial. The 180 female participants were aged between 18 and 45, with schizophrenia and ongoing symptoms of psychosis Positive and Negative Syndrome Scale (PANSS) score > 60 despite a stable dose of antipsychotic medication. Depressive symptoms were assessed using Montgomery Asberg Depression Scale (MADRS) with a mean score of 73.77 at baseline. Participants received transdermal oestradiol 200 μg or transdermal oestradiol 100 μg or an identical placebo patch. The a priori outcome measure was the change in PANSS score measured at baseline and days 7, 14, 28 and 56, but in this study, we focused on the change in MADRS score at the same time points. Data were analysed by using Quade's rank analysis of covariance (ANCOVA) (Huitema 1980) with baseline MADRS score as a covariate. We found a fluctuating but overall trend towards improvement of comorbid depressive symptoms in women with schizophrenia taking transdermal oestrogen 200 mcg compared with oestrogen 100 mcg or placebo. The stronger 'antidepressant' effect of 200 mcg transdermal oestradiol was found at day 28 (p = 0.03). Our study suggests that adjunctive oestradiol treatment for depression may be a promising treatment for women with comorbid depression and schizophrenia.",2020,The stronger 'antidepressant' effect of 200 mcg transdermal oestradiol was found at day 28 (p = 0.03).,"['Women with schizophrenia', 'women with comorbid depression and schizophrenia', 'women with schizophrenia taking', '180 female participants were aged between 18 and 45, with schizophrenia and ongoing symptoms of psychosis Positive and Negative Syndrome Scale (PANSS', 'women with schizophrenia']","['oestradiol treatment', 'oestrogen 100\xa0mcg or placebo', 'adjunctive oestradiol', '200\xa0mcg transdermal oestradiol', 'transdermal oestradiol 200\xa0μg or transdermal oestradiol 100\xa0μg or an identical placebo patch', 'transdermal oestrogen']","['Depressive symptoms', 'change in PANSS score', 'comorbid depressive symptoms', 'MADRS score', 'Montgomery Asberg Depression Scale (MADRS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",,0.625266,The stronger 'antidepressant' effect of 200 mcg transdermal oestradiol was found at day 28 (p = 0.03).,"[{'ForeName': 'M Bové', 'Initials': 'MB', 'LastName': 'Lascurain', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Camuñas-Palacín', 'Affiliation': 'Parc Sanitari Sant Joan De Deu (PSSJD), Sant Boi De Llobregat, Barcelona, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Breadon', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gavrilidis', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Hudaib', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gurvich', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kulkarni', 'Affiliation': 'The Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Monash University, Melbourne, Australia. jayashri.kulkarni@monash.edu.'}]",Archives of women's mental health,['10.1007/s00737-019-00959-3']
185,32278195,Cardiorespiratory responses to fine particles during ambient PM 2.5  pollution waves: Findings from a randomized crossover trial in young healthy adults.,"BACKGROUND


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


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


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


PPWs could affect cardiopulmonary health through systematic oxidative stress, platelet activation and respiratory inflammation in healthy adults, and short-term indoor air purification could alleviate the adverse cardiopulmonary effects.",2020,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","['healthy adults', 'young healthy adults', '29 healthy young adults']",[],"['blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress', 'levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α', 'FeNO and soluble P-selectin (sP-selectin', 'cardiopulmonary mortality and morbidity', 'health biomarkers', 'Cardiorespiratory responses', 'sP-selectin', 'pulmonary function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0335382,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: jing_huang@bjmu.edu.cn.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: guoxb@bjmu.edu.cn.'}]",Environment international,['10.1016/j.envint.2020.105590']
186,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
187,32208176,The effects of short-term moderate intensity aerobic exercise and long-term detraining on electrocardiogram indices and cardiac biomarkers in postmenopausal women.,"OBJECTIVE


The purpose of this study was to investigate the effects of 12-week of moderate-intensity aerobic exercise and 5-month detraining on electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P) in postmenopausal women (PMWs).
MATERIALS AND METHODS


Thirty-one PMWs (aged 50-70 yrs) were randomized to exercise (EX, n = 16) and control (C, n = 15) groups. EX group performed of 12-week of warm up- walking/jogging moderate intensity aerobic exercise training program- recovery (60 min/day, 3 days/week at 70% of maximal heart rate reserve), and then 5-month detraining remained. C group maintain their normal lifestyle during 8 months. The ECG indices and cardiac serum levels were measured at baseline, after 12-week exercise, and after 5-month detraining.
RESULTS


After 12-week exercise intervention, P-R interval, serum PTH and serum Vit D were significantly increased in the EX group compared to the C group (P = 0.020, P = 0.001 and P = 0.001, respectively). After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
CONCLUSIONS


The results suggested that 12-week of moderate intensity aerobic exercise increased the P-R interval, PTH and Vit D, as severe Vit D deficiency status (below 10 ng/ml) improved to Vit D deficiency status (between 10 and 20 ng/ml) in PMWs. Also, long-term positive adaptations to aerobic exercise such as increased Vit D were observed even after 5-month detraining. In addition, P-R segment and S-T interval decreased after 5-month detraining in sedentary PMWs, which may be a sign of atrial positive adaptations to aerobic exercise.",2020,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","['postmenopausal women (PMWs', 'postmenopausal women', 'Thirty-one PMWs (aged 50-70\xa0yrs']","['warm up- walking/jogging moderate intensity aerobic exercise training program- recovery', 'exercise (EX', 'short-term moderate intensity aerobic exercise and long-term detraining', 'moderate-intensity aerobic exercise and 5-month detraining', 'moderate intensity aerobic exercise']","['Vit D', 'electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P', 'ECG indices and cardiac serum levels', 'electrocardiogram indices and cardiac biomarkers', 'P-R interval, serum PTH and serum Vit D', 'serum Vit D', 'Vit D deficiency status', 'P-R segment and S-T interval', 'P-R interval, PTH and Vit D, as severe Vit D deficiency status']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520879', 'cui_str': 'P-R segment, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0251744,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Exercise Physiology, Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Fellowship of Balloon Angioplasty, Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Clinical Biochemistry, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.004']
188,27819485,Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression.,"The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of Ω3, PEP+placebo, Ω3+PEP, or placebo. Ω3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, Ω3+PEP; 61%, PEP+placebo; 44%, Ω3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and Ω3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of Ω3; results warrant further evaluation in a larger sample. Ω3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.",2019,"Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression.","['youth with depression', '72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified', 'Children and Adolescents With Depression']","['placebo', 'PEP+placebo', 'PEP', 'psychotherapy', 'PEP+placebo, Ω3+PEP, or placebo', 'omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP', 'Omega-3 and Individual-Family Psychoeducational Psychotherapy']","['Side effects', 'tolerated', 'Remission rates', 'Remission', ""Children's Depression Rating Scale-Revised""]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0013415', 'cui_str': 'Dysthymic Disorder'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",,0.54154,"Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression.","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Fristad', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Vesco', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'K Zachary', 'Initials': 'KZ', 'LastName': 'Healy', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Elias S', 'Initials': 'ES', 'LastName': 'Nader', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gardner', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Adina M', 'Initials': 'AM', 'LastName': 'Seidenfeld', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Wolfson', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'a Department of Psychiatry and Behavioral Health , The Ohio State University Wexner Medical Center.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1233500']
189,27831829,Dynamic Change of Aggressive Behavior and Victimization Among Adolescents: Effectiveness of the ViSC Program.,"The present study reports a high-quality evaluation of the ViSC Social Competence Program, which was implemented large scale in Austria. A rigorous test of program effectiveness has been performed to investigate the dynamic change of aggressive behavior and victimization and to ensure a high level of statistical conclusion validity. A cluster randomized control study was applied to examine program effectiveness regarding aggressive behavior and victimization. In sum, 1,377 adolescents (48.5% girls, M age  = 11.7) enrolled in 13 schools participated in the program; 665 adolescents (45.2% girls, M age  = 11.6) enrolled in 5 schools were in the control group. Data were collected with Internet-based questionnaires at pre- and posttest with several validated scales to capture the full range of the two constructs. To ensure construct validity, a series of invariance tests of the second-order factor models were performed. To test program effectiveness, a multiple group bivariate latent change score model was applied. Evidence for a dynamic change of aggressive behavior and victimization was found. As predicted, the pretest levels and the change scores of aggressive behavior and victimization were associated. Moreover, higher levels of pretest values predicted more change. The program was effective in reducing victimization but not aggressive behavior. Gender did not moderate the results. Results are important for national rollout and cross-national dissemination of the program. However, further research is needed to investigate the underlying mechanisms of the intervention effects.",2019,The program was effective in reducing victimization but not aggressive behavior.,"['1,377 adolescents (48.5% girls, M age \xa0=\xa011.7) enrolled in 13 schools participated in the program; 665 adolescents (45.2% girls, M age \xa0=\xa011.6) enrolled in 5 schools were in the control group', 'Adolescents']",[],['Dynamic Change of Aggressive Behavior and Victimization'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",5.0,0.0167746,The program was effective in reducing victimization but not aggressive behavior.,"[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Yanagida', 'Affiliation': 'a School of Medical Engineering and Applied Social Sciences , University of Applied Sciences Upper Austria.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Strohmeier', 'Affiliation': 'a School of Medical Engineering and Applied Social Sciences , University of Applied Sciences Upper Austria.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Spiel', 'Affiliation': 'b Department of Applied Psychology: Work, Education, Economy , University of Vienna.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1233498']
190,27918841,Community Effectiveness RCT of a Comprehensive Psychosocial Treatment for High-Functioning Children With ASD.,"This community effectiveness randomized clinical trial examined the feasibility and effectiveness of a comprehensive psychosocial treatment, summerMAX, when implemented by a community agency. Fifty-seven high-functioning children (48 male, 9 female), ages 7-12 years with autism spectrum disorder participated in this study. The 5-week summerMAX treatment included instruction and therapeutic activities targeting social/social-communication skills, interpretation of nonliteral language skills, face-emotion recognition skills, and interest expansion. A behavioral program was also used to increase skills acquisition and decrease autism spectrum disorder symptoms and problem behaviors. Feasibility was supported via high levels of fidelity and parent, child, and staff clinician satisfaction. Significant treatment effects favoring the treatment group over waitlist controls were found on all 5 of the primary outcome measures (i.e., child test of nonliteral language skills and parent ratings of the children's autism spectrum disorder symptoms, targeted social/social-communication skills, broader social performance, and withdrawal). Staff clinician ratings substantiated the improvements reported by parents. Results of this randomized clinical trial are consistent with those of prior studies of summerMAX and suggest that the program was feasible and effective when implemented by a community agency under real-world conditions.",2019,"Significant treatment effects favoring the treatment group over waitlist controls were found on all 5 of the primary outcome measures (i.e., child test of nonliteral language skills and parent ratings of the children's autism spectrum disorder symptoms, targeted social/social-communication skills, broader social performance, and withdrawal).","['High-Functioning Children With ASD', 'Fifty-seven high-functioning children (48 male, 9 female), ages 7-12\xa0years with autism spectrum disorder participated in this study']","['comprehensive psychosocial treatment, summerMAX', 'summerMAX treatment included instruction and therapeutic activities targeting social/social-communication skills, interpretation of nonliteral language skills, face-emotion recognition skills, and interest expansion', 'Comprehensive Psychosocial Treatment', 'summerMAX']","['fidelity and parent, child, and staff clinician satisfaction', 'skills acquisition and decrease autism spectrum disorder symptoms and problem behaviors', ""child test of nonliteral language skills and parent ratings of the children's autism spectrum disorder symptoms, targeted social/social-communication skills, broader social performance, and withdrawal""]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",57.0,0.055755,"Significant treatment effects favoring the treatment group over waitlist controls were found on all 5 of the primary outcome measures (i.e., child test of nonliteral language skills and parent ratings of the children's autism spectrum disorder symptoms, targeted social/social-communication skills, broader social performance, and withdrawal).","[{'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Thomeer', 'Affiliation': 'a Institute for Autism Research , Canisius College.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lopata', 'Affiliation': 'a Institute for Autism Research , Canisius College.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'a Institute for Autism Research , Canisius College.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'b Department of Counseling, School, and Educational Psychology, University at Buffalo, State University of New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shanahan', 'Affiliation': 'c Autism Services, Inc .'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Federiconi', 'Affiliation': 'c Autism Services, Inc .'}, {'ForeName': 'Christin A', 'Initials': 'CA', 'LastName': 'McDonald', 'Affiliation': 'a Institute for Autism Research , Canisius College.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Rodgers', 'Affiliation': 'a Institute for Autism Research , Canisius College.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1247359']
191,32334176,"The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 h: A randomized, controlled, non-inferiority trial.","BACKGROUND


Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 h remains widely practiced.
OBJECTIVE


To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 h to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared.
SETTING


Multi-center trial in wards at two hospitals in Sao Paulo, Brazil.
DESIGN


The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 h (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial.
PARTICIPANTS


1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm 3 , and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 h of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list.
METHODS


As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases.
RESULTS


Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode.
CONCLUSIONS


Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 h) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT02568670).",2020,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","['Multi-center trial in wards at two hospitals in Sao Paulo, Brazil', '1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96\xa0h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided']","['peripheral intravenous catheters', 'peripheral intravenous catheter replacement', 'peripheral intravenous catheter removal']","['Phlebitis', 'phlebitis', 'intention-to-treat and per-protocol bases', 'Phlebitis severity, catheter indwelling time, and other catheter failure types']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",1319.0,0.175394,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vendramim', 'Affiliation': 'Specialist in pediatric intensive care, M.Sc., Ph.D. in Health Science of Federal University of Sao Paulo, 258 Aimberê, St. Sao Paulo, Brazil. Electronic address: patvendramim@gmail.com.'}, {'ForeName': 'Ariane Ferreira Machado', 'Initials': 'AFM', 'LastName': 'Avelar', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: ariane.machado@unifesp.br.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Griffith University - Australia, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'Mavilde da Luz Gonçalves', 'Initials': 'MDLG', 'LastName': 'Pedreira', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: mpedreira@unifesp.br.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103504']
192,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND


Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.
OBJECTIVE


To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.
METHODS


We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.
RESULTS


We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
CONCLUSIONS


The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
193,32305650,"The impact of an educational video about radiotherapy and its toxicities in head and neck cancer patients. Evaluation of patients' understanding, anxiety, depression, and quality of life.","OBJECTIVES


Head and neck radiotherapy can cause several toxicities, and its management has important treatment implications. Proper information about treatment is crucial to assist patients by preparing them and enhancing their ability to manage their illness. Thus, this study aimed to verify the impact of an educational video on the improvement of the patient's understanding, satisfaction, quality of life, and influence on their emotional state in different moments of treatment.
METHODS


A 10 min video about head and neck radiotherapy and its toxicities was produced. A prospective randomized clinical trial was performed in two groups: a control group (n = 65), which received standard verbal and written information, and an experimental group (n = 65), which received standard information and the video. Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU) were applied in four different moments in order to evaluate patients' understanding, anxiety, depression, and quality of life.
RESULTS


The video improved the understanding of treatment and its side effects. Also, the video group reported better awareness about oral health care during the treatment. Osteoradionecrosis and radiation-related caries were the most unknown side effects. On the other hand, the educational video did not modify the patients' anxiety, depression, and quality of life. All patients reported high satisfaction with the video.
CONCLUSIONS


Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers. In addition, information about osteoradionecrosis and radiation-related caries must be reinforced to patients.",2020,"CONCLUSIONS


Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.",['head and neck cancer patients'],"['standard verbal and written information, and an experimental group (n\xa0=\xa065), which received standard information and the video', 'educational video about radiotherapy', 'educational video']","['anxiety, depression, and quality of life', 'Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU', 'awareness about oral health care', ""patients' anxiety, depression, and quality of life""]","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0257791,"CONCLUSIONS


Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.","[{'ForeName': 'Diego Tetzner', 'Initials': 'DT', 'LastName': 'Fernandes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Prado-Ribeiro', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Renata Lucena', 'Initials': 'RL', 'LastName': 'Markman', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Morais', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Moutinho', 'Affiliation': 'Department of Radiology and Oncology, Faculdade de Medicina, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Juliana Ono', 'Initials': 'JO', 'LastName': 'Tonaki', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Thaís Bianca', 'Initials': 'TB', 'LastName': 'Brandão', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Oral Pathology and Medicine Research Group, Department of Basic Biomedical Sciences, Faculty of Health Sciences, Universidad de Talca, Chile.'}, {'ForeName': 'Alan Roger', 'Initials': 'AR', 'LastName': 'Santos-Silva', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Márcio Ajudarte', 'Initials': 'MA', 'LastName': 'Lopes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil. Electronic address: malopes@fop.unicamp.br.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104712']
194,32244044,Task-dependent modulation of corticospinal excitability and inhibition following strength training.,"This study determined whether there are task-dependent differences in cortical excitability following different types of strength training. Transcranial magnetic stimulation (TMS) measured corticospinal excitability (CSE) and intracortical inhibition (ICI) of the biceps brachii muscle in 42 healthy subjects that were randomised to either paced-strength-training (PST, n = 11), self-paced strength-training (SPST, n = 11), isometric strength-training (IST, n = 10) or to a control group (n = 10). Single-pulse and paired-pulse TMS were applied prior to and following 4-weeks of strength-training. PST increased CSE compared to SPST, IST and the control group (all P < 0.05). ICI was only reduced (60%) following PST. Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST. There were no associations between the behavioural outcome measures and the change in CSE and ICI. The corticospinal responses to strength-training are task-dependent, which is a new finding. Strength-training that is performed slowly could promote use-dependent plasticity in populations with reduced volitional drive, such as during periods of limb immobilization, musculoskeletal injury or stroke.",2020,"Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST.",['42 healthy subjects'],"['paced-strength-training (PST, n\xa0=\xa011), self-paced strength-training (SPST, n\xa0=\xa011), isometric strength-training (IST, n\xa0=\xa010) or to a control group', 'Single-pulse and paired-pulse TMS', 'Transcranial magnetic stimulation (TMS', 'strength training']","['Dynamic strength', 'corticospinal excitability (CSE) and intracortical inhibition (ICI', 'PST increased CSE', 'change in CSE and ICI', 'ICI', 'isometric strength', 'cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",42.0,0.0265563,"Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST.","[{'ForeName': 'Ummatul', 'Initials': 'U', 'LastName': 'Siddique', 'Affiliation': 'Department of Neurology, Institute of Neurosciences, Kolkata, India.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Neurology, Institute of Neurosciences, Kolkata, India.'}, {'ForeName': 'Ashlyn', 'Initials': 'A', 'LastName': 'Frazer', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Pearce', 'Affiliation': 'College of Science, Health and Engineering, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Dawson J', 'Initials': 'DJ', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia. Electronic address: dawson.kidgell@monash.edu.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102411']
195,30376652,Cluster Randomized Trial of a School Intervention for Children with Autism Spectrum Disorder.,"There are currently no empirically supported, comprehensive school-based interventions (CSBIs) for children with autism spectrum disorder (ASD) without concomitant intellectual and language disability. This study compared outcomes for a CSBI (schoolMAX) to typical educational programming (services-as-usual [SAU]) for these children. A total of 103 children (6-12 years of age) with ASD (without intellectual and language disability) were randomly assigned by school buildings (clusters) to receive the CSBI ( n =  52 completed) or SAU ( n  = 50 completed). The CSBI was implemented by trained school personnel and targeted social competence and ASD symptoms using social skills groups, emotion recognition instruction, therapeutic activities, behavioral reinforcement, and parent training. Outcome measures tested the effects of the CSBI on social competence and ASD symptoms, as well as potential collateral effects on academic achievement. Outcomes (baseline-to-follow-up) were assessed using tests of social cognition and academic skills and behavioral observations (by masked evaluators) and parent-teacher ratings of ASD symptoms and social/social-communication skills (nonmasked; ClinicalTrials.gov, NCT03338530, https://www.clinicaltrials.gov/). The CSBI group improved significantly more than the SAU group on the test of emotion recognition skills and parent-teacher ratings of ASD symptoms (primary outcomes) and social/social-communication skills (secondary outcome). No differences between groups were detected for recess social interactions or academic skills. The CSBI improved several core areas of functioning for children with ASD compared to usual educational programming. Additional intervention elements may be needed to expand the efficacy of the CSBI so that the observed skills/symptom improvements generalize to recess social interactions and/or academic skills are enhanced.",2019,The CSBI group improved significantly more than the SAU group on the test of emotion recognition skills and parent-teacher ratings of ASD symptoms (primary outcomes) and social/social-communication skills (secondary outcome).,"['Children with Autism Spectrum Disorder', '103 children (6-12\xa0years of age) with ASD (without intellectual and language disability', 'children with autism spectrum disorder (ASD) without concomitant intellectual and language disability', 'children with ASD']","['School Intervention', 'SAU', 'school buildings (clusters) to receive the CSBI (n\xa0=\xa052 completed) or SAU', 'comprehensive school-based interventions (CSBIs', 'CSBI (schoolMAX) to typical educational programming (services-as-usual [SAU']","['social cognition and academic skills and behavioral observations (by masked evaluators) and parent-teacher ratings of ASD symptoms and social/social-communication skills (nonmasked; ClinicalTrials.gov, NCT03338530, https://www.clinicaltrials.gov/ ', 'social competence and ASD symptoms, as well as potential collateral effects on academic achievement', 'recess social interactions or academic skills', 'emotion recognition skills and parent-teacher ratings of ASD symptoms (primary outcomes) and social/social-communication skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557796', 'cui_str': 'Comprehensive school (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0558039', 'cui_str': 'Behavior Observation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",103.0,0.0712231,The CSBI group improved significantly more than the SAU group on the test of emotion recognition skills and parent-teacher ratings of ASD symptoms (primary outcomes) and social/social-communication skills (secondary outcome).,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lopata', 'Affiliation': 'Institute for Autism Research, Canisius College.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Thomeer', 'Affiliation': 'Institute for Autism Research, Canisius College.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Rodgers', 'Affiliation': 'Institute for Autism Research, Canisius College.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'Institute for Autism Research, Canisius College.'}, {'ForeName': 'Christin A', 'Initials': 'CA', 'LastName': 'McDonald', 'Affiliation': ""Center for Autism Spectrum Disorders, Nationwide Children's Hospital.""}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Volker', 'Affiliation': 'Department of Counseling, Educational Psychology and Special Education, Michigan State University.'}, {'ForeName': 'Tristram H', 'Initials': 'TH', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, University of Rochester.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1520121']
196,30982086,Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial.,"Pregnant women are at high risk of mood and anxiety disorders, and options for non-pharmacological treatment are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among people with mood and anxiety disorders, but limited studies reported the effectiveness of MBCT on perinatal comorbid conditions. This study aimed to examine the effects of an 8-week MBCT intervention on pregnant women with comorbid depression and anxiety. In this randomized controlled study, 38 pregnant women with a diagnosis of depression and varying levels of comorbid anxiety disorders were randomly assigned to either MBCT or a control group. Scores on the Beck Depression Inventory-II, Beck Anxiety Inventory, Emotion Regulation Questionnaire, and Scales of Psychological Wellbeing were used as outcome measures at baseline, after MBCT, and through 1-month follow-up. Intent to treat analyses provided preliminary evidence that MBCT can be effective in reducing depressive and anxiety symptoms and in enhancing the use of adaptive emotion regulation strategies and psychological well-being. Improvements in outcomes were maintained 1 month. Results provide cross-cultural support for MBCT as a treatment for depression and anxiety in pregnant women. This brief and non-pharmacological treatment can be used to improve maternal psychological health.",2020,Intent to treat analyses provided preliminary evidence that MBCT can be effective in reducing depressive and anxiety symptoms and in enhancing the use of adaptive emotion regulation strategies and psychological well-being.,"['38 pregnant women with a diagnosis of depression and varying levels of comorbid anxiety disorders', 'pregnant women', 'people with mood and anxiety disorders', 'pregnant women with comorbid depression and anxiety', 'Pregnant women', 'comorbid depression and anxiety in pregnancy']","['mindfulness-based cognitive therapy', 'MBCT intervention', 'MBCT', 'Mindfulness-based cognitive therapy (MBCT']","['Beck Depression Inventory-II, Beck Anxiety Inventory, Emotion Regulation Questionnaire, and Scales of Psychological Wellbeing', 'maternal psychological health', 'depressive and anxiety symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4543692', 'cui_str': 'Anxiety in pregnancy'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",38.0,0.0522266,Intent to treat analyses provided preliminary evidence that MBCT can be effective in reducing depressive and anxiety symptoms and in enhancing the use of adaptive emotion regulation strategies and psychological well-being.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zemestani', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran. m.zemestani@uok.ac.ir.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fazeli Nikoo', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran.'}]",Archives of women's mental health,['10.1007/s00737-019-00962-8']
197,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND


Dementia with Lewy bodies (DLB) is the second most common form of dementia. Current symptomatic treatment with medications remains inadequate. Deep brain stimulation of the nucleus basalis of Meynert (NBM DBS) has been proposed as a potential new treatment option in dementias.
OBJECTIVE


To assess the safety and tolerability of low frequency (20 Hz) NBM DBS in DLB patients and explore its potential effects on both clinical symptoms and functional connectivity in underlying cognitive networks.
METHODS


We conducted an exploratory randomised, double-blind, crossover trial of NBM DBS in six DLB patients recruited from two UK neuroscience centres. Patients were aged between 50 and 80 years, had mild-moderate dementia symptoms and were living with a carer-informant. Patients underwent image guided stereotactic implantation of bilateral DBS electrodes with the deepest contacts positioned in the Ch4i subsector of NBM. Patients were subsequently assigned to receive either active or sham stimulation for six weeks, followed by a two week washout period, then the opposite condition for six weeks. Safety and tolerability of both the surgery and stimulation were systematically evaluated throughout. Exploratory outcomes included the difference in scores on standardised measurements of cognitive, psychiatric and motor symptoms between the active and sham stimulation conditions, as well as differences in functional connectivity in discrete cognitive networks on resting state fMRI.
RESULTS


Surgery and stimulation were well tolerated by all six patients (five male, mean age 71.33 years). One serious adverse event occurred: one patient developed antibiotic-associated colitis, prolonging his hospital stay by two weeks. No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients. Active stimulation was associated with functional connectivity changes in both the default mode network and the frontoparietal network.
CONCLUSION


Low frequency NBM DBS can be safely conducted in DLB patients. This should encourage further exploration of the possible effects of stimulation on neuropsychiatric symptoms and corresponding changes in functional connectivity in cognitive networks.
TRIAL REGISTRATION NUMBER


NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010']
198,31309919,Long-term vitamin D and high-dose  n -3 fatty acids' supplementation improve markers of cardiometabolic risk in type 2 diabetic patients with CHD.,"This study was performed to evaluate the effects of vitamin D and n-3 fatty acids' co-supplementation on markers of cardiometabolic risk in diabetic patients with CHD. This randomised, double-blinded, placebo-controlled trial was conducted among sixty-one vitamin D-deficient diabetic patients with CHD. At baseline, the range of serum 25-hydroxyvitamin D levels in study participants was 6·3-19·9 ng/ml. Subjects were randomly assigned into two groups either taking 50 000 IU vitamin D supplements every 2 weeks plus 2× 1000 mg/d n-3 fatty acids from flaxseed oil (n 30) or placebo (n 31) for 6 months. Vitamin D and n-3 fatty acids' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo. In addition, co-supplementation led to a significant reduction in fasting plasma glucose (β -0·40 mmol/l; 95 % CI -0·77, -0·03; P = 0·03), insulin (β -1·66 μIU/ml; 95 % CI -2·43, -0·89; P < 0·001), insulin resistance (β -0·49; 95 % CI -0·72, -0·25; P < 0·001) and LDL-cholesterol (β -0·21 mmol/l; 95 % CI -0·41, -0·01; P = 0·04), and a significant increase in insulin sensitivity (β +0·008; 95 % CI 0·004, 0·01; P = 0·001) and HDL-cholesterol (β +0·09 mmol/l; 95 % CI 0·01, 0·17; P = 0·02) compared with the placebo. Additionally, high-sensitivity C-reactive protein (β -1·56 mg/l; 95 % CI -2·65, -0·48; P = 0·005) was reduced in the supplemented group compared with the placebo group. Overall, vitamin D and n-3 fatty acids' co-supplementation had beneficial effects on markers of cardiometabolic risk.",2019,"' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo.","['0·17', 'type 2 diabetic patients with CHD', 'diabetic patients with CHD', 'sixty-one vitamin D-deficient diabetic patients with CHD']","['n-3 fatty acids from flaxseed oil (n 30) or placebo', 'placebo', ""Long-term vitamin D and high-dose n-3 fatty acids' supplementation"", ""vitamin D and n-3 fatty acids' co-supplementation"", 'Vitamin D and n-3 fatty acids', 'IU vitamin D supplements']","['HDL-cholesterol', 'maximum levels of left carotid intima-media thickness (CIMT', 'LDL-cholesterol', 'insulin sensitivity', 'cardiometabolic risk', 'insulin resistance', 'fasting plasma glucose', 'maximum levels of right CIMT', 'range of serum 25-hydroxyvitamin D levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C0632490', 'cui_str': 'N 30'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",61.0,0.769996,"' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo.","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Talari', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Najafi', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Raygan', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': 'School of Public Health, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hajijafari', 'Affiliation': 'Trauma Research Center, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}]",The British journal of nutrition,['10.1017/S0007114519001132']
199,31347994,Rate of gestational weight gain and adverse pregnancy outcomes in rural nulliparous women: a prospective cohort analysis from China.,"Both inadequate and excessive gestational weight gain (GWG) have been shown to increase the risk of adverse pregnancy outcomes, but the risk profiles of GWG rate are unclear. We aimed to examine the associations between GWG rate in the second/third trimester and a spectrum of pregnancy outcomes. This study consisted of 14 219 Chinese rural nulliparous women who participated in a randomised controlled trial of prenatal micronutrient supplementation during 2006-2009. The outcomes included stillbirth, neonatal and infant death, preterm birth, macrosomia, low birth weight (LBW) and large and small for gestational age (LGA and SGA, respectively). GWG rate was divided into quintiles within each BMI category. Compared with women in the middle quintile, those in the lowest quintile had higher risks of neonatal death (adjusted OR 2·27; 95 % CI 1·03, 5·02), infant death (adjusted OR 1·85; 95 % CI 1·02, 3·37) and early preterm birth (adjusted OR 2·33; 95 % CI 1·13, 4·77), while those in the highest quintile had higher risks of overall preterm birth (adjusted OR 1·28; 95 % CI 1·04, 1·59), late preterm birth (adjusted OR 1·25; 95 % CI 1·00, 1·56), LBW (adjusted OR 1·48; 95 % CI 1·02, 2·15), macrosomia (adjusted OR 1·89; 95 % CI 1·46, 2·45) and LGA (adjusted OR 1·56; 95 % CI 1·31, 1·85). In conclusion, very low and very high GWG rates in the second/third trimester appear to be associated with adverse pregnancy outcomes in Chinese nulliparous women, indicating that an appropriate GWG rate during pregnancy is necessary for neonatal health.",2019,"Compared with women in the middle quintile, those in the lowest quintile had higher risks of neonatal death (adjusted OR 2·27; 95 % CI 1·03, 5·02), infant death (adjusted OR 1·85; 95 % CI 1·02, 3·37) and early preterm birth (adjusted OR 2·33; 95 % CI 1·13, 4·77), while those in the highest quintile had higher risks of overall preterm birth (adjusted OR 1·28; 95 % CI 1·04, 1·59), late preterm birth (adjusted OR 1·25; 95 % CI 1·00, 1·56), LBW (adjusted OR 1·48; 95 % CI 1·02, 2·15), macrosomia (adjusted OR 1·89; 95 % CI 1·46, 2·45) and LGA (adjusted OR 1·56; 95 % CI 1·31, 1·85).","['14 219 Chinese rural nulliparous women who participated', 'Chinese nulliparous women', 'rural nulliparous women']",['prenatal micronutrient supplementation'],"['infant death', 'gestational weight gain and adverse pregnancy outcomes', 'GWG rate', 'stillbirth, neonatal and infant death, preterm birth, macrosomia, low birth weight (LBW) and large and small for gestational age (LGA and SGA, respectively', 'early preterm birth', 'late preterm birth', 'adverse pregnancy outcomes', 'GWG rates', 'risks of overall preterm birth', 'risks of neonatal death']","[{'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0549159', 'cui_str': 'Infant Death'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}]",,0.400293,"Compared with women in the middle quintile, those in the lowest quintile had higher risks of neonatal death (adjusted OR 2·27; 95 % CI 1·03, 5·02), infant death (adjusted OR 1·85; 95 % CI 1·02, 3·37) and early preterm birth (adjusted OR 2·33; 95 % CI 1·13, 4·77), while those in the highest quintile had higher risks of overall preterm birth (adjusted OR 1·28; 95 % CI 1·04, 1·59), late preterm birth (adjusted OR 1·25; 95 % CI 1·00, 1·56), LBW (adjusted OR 1·48; 95 % CI 1·02, 2·15), macrosomia (adjusted OR 1·89; 95 % CI 1·46, 2·45) and LGA (adjusted OR 1·56; 95 % CI 1·31, 1·85).","[{'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}, {'ForeName': 'Hongtian', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}, {'ForeName': 'Jufen', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}, {'ForeName': 'Jianmeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Institute of Reproductive and Child Health, Ministry of Health Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, People's Republic of China.""}]",The British journal of nutrition,['10.1017/S0007114519001247']
200,32088652,Comparison of MS inflammatory activity in women using continuous versus cyclic combined oral contraceptives.,"BACKGROUND


Many women with multiple sclerosis (MS) report fluctuating symptoms across their menstrual cycle. Oral contraceptives (OCs) alter hormonal levels across the menstrual cycle. While cyclic OCs administer hormones for 21 days, followed by a week of placebo, continuous OCs can administer continuous doses of hormones for up to 3 months. Previous studies have suggested that OC use is associated with lower MS-related inflammation. We hypothesized that due to reduced hormonal fluctuations, women with MS might experience less inflammatory activity (clinical relapses+MRI) on continuous OCs than on cyclic OCs.
METHODS


We performed a retrospective analysis of prospectively collected data. For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation, we extracted data on OC use from the Electronic Medical Records (EMR). All variables were confirmed using manual clinical chart review. We identified 19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type. Inflammatory activity in the two groups was then compared using log-rank tests (time to new relapse, new T2-weighted lesion formation, and gadolinium-enhancing lesion formation) and t-tests (annualized relapse rate). We also performed subgroup analyses in women with at least 1 year (N = 28) and 2 years (N = 21) of clinical observation. A power calculation was performed.
RESULTS


There was no difference in time to relapse (p = 0.50) between continuous and cycling OC users. However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05). In patients with at least 1 year of observation, there was a significant difference in time to T2 lesion formation (p = 0.03) and time to contrast-enhancing lesion formation (p = 0.02).
CONCLUSION


In this exploratory study, women on continuous OCs showed a trend towards less inflammatory activity on MRI relative to women on cyclic OCs. This difference was not reflected in relapse rates. We estimate that 342 patients would be required for an adequately powered cohort study to evaluate such an effect. Our findings provide reassurance that for women using continuous OCs to alleviate menstrual fluctuations in symptoms, there is not an increase in MS-related inflammatory activity.",2020,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","['19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type', 'women with at least 1 year (N\u202f=\u202f28) and 2 years (N\u202f=\u202f21) of clinical observation', '342 patients', 'For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation', 'women using continuous versus cyclic combined oral contraceptives']","['Oral contraceptives (OCs', 'placebo, continuous OCs']","['MS inflammatory activity', 'time to relapse', 'time to contrast-enhancing lesion formation', 'Inflammatory activity', 'relapse rates', 'longer time to contrast-enhancing lesion formation', 'longer time to T2 lesion formation', 'time to T2 lesion formation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",342.0,0.070475,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chelsea.chen@ucsf.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Krishnakumar', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: tanya.krishnakumar@ucsf.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: william.rowles@ucsf.edu.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: annika.anderson@ucsf.edu.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chao.zhao@ucsf.edu.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: lvtieu@gmail.com.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Bove', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: riley.bove@ucsf.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.101970']
201,32333407,Exploration of suitable pharmacodynamic parameters for acarbose bioequivalence evaluation: A series of clinical trials with branded acarbose.,"AIMS


To determine deficiencies in the Food and Drug Administration (FDA)'s guidance for assessing acarbose bioequivalence (BE) and to explore optimal pharmacodynamic (PD) metrics for better evaluation of acarbose BE.
METHODS


Three clinical trials with branded acarbose were conducted in healthy subjects, including a pilot study (Study I, n = 11, 50 and 100 mg), a 2×2 crossover BE study (Study II, n = 36, 100 mg) and a 4×4 Williams study (Study III, n = 16, 50/100/150 mg). Serum glucose concentrations were measured by the glucose oxidase method.
RESULTS


In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96 ± 0.83 mmol/L vs 6.78 ± 1.02 mmol/L, P < .05). In Study II, the geometric mean ratios of the test formulation to the reference formulation (both formulations were the branded drug) for FDA PD metrics, ΔC max0-4h  and ΔAUC 0-4h  , were 0.903 and 0.776, respectively, and the 90% confidence intervals were 67.44-120.90 and 53.65-112.13, respectively. The geometric mean ratios (confidence interval) for possible optimal evaluation PD metrics (C max0-2h  and AUC 0-2h  ) were 1.035 (94.23-112.68) and 0.982 (89.28-107.17), respectively. Further, C max0-2h  and AUC 0-2h  also met the sensitivity requirements for BE evaluation in Study III.
CONCLUSION


Considering the mechanisms of action of acarbose, the PD effect was shown to be dose independent during the 2-4 hours postadministration of acarbose. Hence PD metrics based on the serum glucose concentration from 0 to 2 hours (C max0-2h  and AUC 0-2h  ) are more sensitive than the FDA-recommended PD metrics for acarbose BE evaluation from 0-4 hours (ΔC max0-4h  and ΔAUC 0-4h  ). The trial has been registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn, ChiCTR1800015795, ChiCTR-IIR-17013918, ChiCTR-IIR-17011903). All subjects provided written informed consent before screening.",2020,"In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96±0.83 mmol/",['healthy subjects'],"['branded acarbose', 'acarbose']","['serum glucose concentration', 'geometric mean ratios (GMRs', 'Serum glucose concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0338336,"In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96±0.83 mmol/","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Liu', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Yang', 'Affiliation': 'Centre for Drug Evaluation, National Medical Products Administration, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Centre for Drug Evaluation, National Medical Products Administration, Beijing, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Cheng-Xian', 'Initials': 'CX', 'LastName': 'Guo', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jin-Lian', 'Initials': 'JL', 'LastName': 'Xie', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Huang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Clinc Lab Center, The Third Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14324']
202,32333564,"Effects of robot-assisted gait training combined with virtual reality on motor and cognitive functions in patients with multiple sclerosis: A pilot, single-blind, randomized controlled trial.","BACKGROUND


Studies on robot-assisted gait training rehabilitation in multiple sclerosis have reported positive effects on mobility and quality of life. However, their effects on cognitive functions are difficult to determine because not all trials have included cognition assessments. Virtual reality-based training provides enhanced opportunity for stimulating cognitive abilities by repetitive practice, feedback information, and motivation for endurance practice.
OBJECTIVE


To compare the effects of innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training on information processing speed, sustained attention, working memory, and walking endurance in patients with multiple sclerosis.
METHODS


Seventeen outpatients were randomly assigned to receive robot-assisted gait training either with or without virtual reality. The robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality. The standard training group underwent end-effector system training. A blinded rater evaluated patients before and after treatment and at one month follow-up. The outcome measures were the Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment.
RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group. Significant improvement were obtained also in executive functions (p = 0.012). Both gains were maintained at the 1-month follow-up evaluation (p = 0.012, p = 0.012) in the robot-assisted gait training + virtual reality group. Both group improved quality of life after treatment (Multiple Sclerosis Quality of Life-54: Mental Health p = 0.018, Physical Health p = 0.017).
CONCLUSIONS


Both training lead to positive influenced on executive functions. However larger positive effects on gait ability were noted after robot-assisted gait training engendered by virtual reality with multiple sclerosis. Robot-assisted gait training provides a therapeutic alternative and motivational of traditional motor rehabilitation.",2020,"RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","['patients with multiple sclerosis', 'Seventeen outpatients']","['standard training group underwent end-effector system training', 'robot-assisted gait training either with or without virtual reality', 'robot-assisted gait training combined with virtual reality', 'Virtual reality-based training', 'Robot-assisted gait training', 'innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training', 'robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality', 'robot-assisted gait training rehabilitation']","['executive functions', 'mobility and quality of life', 'motor and cognitive functions', 'Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment', '2-Minutes Walk Test', 'quality of life', 'information processing speed, sustained attention, working memory, and walking endurance', 'gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",17.0,0.0398956,"RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Battistuzzi', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cassini', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Montagnoli', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190974']
203,28103159,The Effects of Stimulant Medication and Training on Sports Competence Among Children With ADHD.,"The current study examined the relative efficacy of behavioral sports training, medication, and their combination in improving sports competence among youth with attention deficit/hyperactivity disorder (ADHD). Participants were 73 youth (74% male; 81% Hispanic) between the ages of 5 and 12 diagnosed with Diagnostic and Statistical Manual of Mental Disorders (4th ed.) ADHD enrolled in a Summer Treatment Program (STP). The study consisted of a 2 (medication: methylphenidate, placebo) × 2 (sports training: instruction and practice, recreational play) between-groups design and was conducted over a 3-week period during the STP. Sports training was conducted with a novel sport, badminton, to limit previous sport knowledge and to differentiate it from concurrent sports training that occurred within the STP. Objective and subjective measures of sports skills, knowledge, and behavior were collected. Results indicated that, relative to recreational play, brief sports training improved observed and counselor-rated measures of sports competence including sports skills, knowledge, game awareness, effort, frustration, and enjoyment. During sports training, medication incrementally improved children's observed rule following behavior and counselor-rated sportsmanship relative to placebo. In the absence of sports training, medication improved behavior, effort, and sport knowledge. Training in sports skills and rules produced the largest magnitude effects on sports-related outcomes. Therefore, skills training, rather than medication alone, should be used in conjunction with behavioral intervention to teach sports to youth with ADHD. It is recommended that medication be used only as an adjunct to highly structured sports skills training for youth who display high rates of negative behavior during sports activities.",2019,"During sports training, medication incrementally improved children's observed rule following behavior and counselor-rated sportsmanship relative to placebo.","['Children With ADHD', 'ADHD enrolled in a Summer Treatment Program (STP', 'Participants were 73 youth (74% male; 81% Hispanic) between the ages of 5 and 12 diagnosed with Diagnostic and Statistical Manual of Mental Disorders (4th ed', 'youth with attention deficit/hyperactivity disorder (ADHD']","['placebo', 'Sports training', '2 (medication: methylphenidate, placebo', 'Stimulant Medication and Training', 'behavioral sports training, medication, and their combination']","['behavior, effort, and sport knowledge', 'Objective and subjective measures of sports skills, knowledge, and behavior', 'Sports Competence', 'relative to recreational play, brief sports training improved observed and counselor-rated measures of sports competence including sports skills, knowledge, game awareness, effort, frustration, and enjoyment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}]",,0.0140562,"During sports training, medication incrementally improved children's observed rule following behavior and counselor-rated sportsmanship relative to placebo.","[{'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Altszuler', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Morrow', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Merrill', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Bressler', 'Affiliation': ""b Department of Child and Adolescent Psychiatry and Behavioral Sciences , Children's Hospital of Philadelphia.""}, {'ForeName': 'Fiona L', 'Initials': 'FL', 'LastName': 'Macphee', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Gnagy', 'Affiliation': 'c Center for Children and Families , Florida International University.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Greiner', 'Affiliation': 'c Center for Children and Families , Florida International University.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Coxe', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Raiker', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Coles', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'a Center for Children and Families and Department of Psychology , Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1270829']
204,28151019,CBT-Enhanced Emotion Regulation as a Mechanism of Improvement for Childhood Irritability.,"Research supports the clinical importance of childhood irritability, as well as its developmental implications for later anxiety and depression. Appropriate treatment may prevent this progression; however, little evidence exists to guide clinician decision making regarding treatment for chronic irritability symptoms. Given the empirical support for irritability as a dimension of oppositional defiant disorder (ODD), behavioral interventions that improve ODD symptoms, especially through emotion regulation training, are strong candidates for identifying effective treatment strategies for irritability. Data from a randomized controlled effectiveness trial were used to assess hypotheses regarding irritability. The Stop Now and Plan (SNAP) Program was developed for preadolescent youths demonstrating clinically high rates of conduct problems. Participants (252 boys, ages 6-11) were assigned to participate in either SNAP or standard services; data were collected at 4 time points over 15 months. Although lower irritability scores over time were seen for the SNAP group compared to standard services, the main effect for treatment was small and did not reach statistical significance. However, a significant indirect effect of SNAP treatment on irritability via improved emotion regulation skills was found; improved emotion regulation skills were associated with significant and substantial reductions in irritability. Specific effects of SNAP for the improvement of emotion regulation skills function as a mechanism for subsequent reductions in irritability, supporting the distinction between emotion regulation and irritability symptoms. Enhancing increased emotion regulation skills within existing evidence-based interventions for children with ODD should provide a strong foundation for treatments to target irritability symptoms.",2019,"Specific effects of SNAP for the improvement of emotion regulation skills function as a mechanism for subsequent reductions in irritability, supporting the distinction between emotion regulation and irritability symptoms.","['Participants (252 boys, ages 6-11', 'children with ODD']","['SNAP', 'CBT-Enhanced Emotion Regulation']","['emotion regulation skills', 'irritability scores', 'irritability', 'irritability via improved emotion regulation skills']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0074709', 'cui_str': 'Snap (resin)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",252.0,0.029787,"Specific effects of SNAP for the improvement of emotion regulation skills function as a mechanism for subsequent reductions in irritability, supporting the distinction between emotion regulation and irritability symptoms.","[{'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Derella', 'Affiliation': 'a Department of Psychological Sciences , University of Connecticut.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Johnston', 'Affiliation': 'a Department of Psychological Sciences , University of Connecticut.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Loeber', 'Affiliation': 'b Western Psychiatric Institute and Clinic , University of Pittsburgh.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Burke', 'Affiliation': 'a Department of Psychological Sciences , University of Connecticut.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1270832']
205,28107027,"Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits.","This goal of this study was to assess the initial feasibility and efficacy of a play-based intervention targeting executive functions (EF) and parent-child relationships in preschoolers compared with an active control group. Preschoolers with EF deficits (M age = 3.7 ± 0.47, predominantly White boys) and their parents were randomized to intervention (n = 36) or active control (n = 32) conditions. Child performance on EF tasks, parent and masked teacher ratings of EF and behavior, and masked clinician ratings of severity were collected at baseline and at 3 and 6 months postbaseline. Partial eta-squared effect sizes at .02 or higher comparing performance across the two groups was considered evidence of meaningful, albeit small, intervention effects. Intervention effects were observed for parent ratings of inattention, hyperactivity/impulsivity, and number/severity of problems experienced in various home situations, teacher ratings of severity of problems in various school situations, parent and teacher ratings of overall impairment, and clinician ratings of impairment. Intervention effects for functional improvements were maintained at the 6-month follow-up. No effect of the intervention was observed on the objective EF measures, although parent ratings of emotional control were improved for children in the intervention group. An intervention utilizing play-based activities targeting EF, when administered in a structured way by parents, is a promising approach for improving behavior in preschoolers with self-regulation deficits. More work is needed to investigate potential impact on EF and to disentangle mechanisms of action. It may be that the intervention's focus on the structure and quality of parent-child interactions is a mediator of outcomes, rather than improved EFs.",2019,"No effect of the intervention was observed on the objective EF measures, although parent ratings of emotional control were improved for children in the intervention group.","['Preschoolers with EF deficits (M age\xa0=\xa03.7\xa0±\xa00.47, predominantly White boys) and their parents', 'preschoolers compared with an active control group', 'preschoolers with self-regulation deficits', 'Preschoolers With Executive Functioning Deficits']","['active control', 'play-based intervention targeting executive functions (EF']","['Child performance on EF tasks, parent and masked teacher ratings of EF and behavior, and masked clinician ratings of severity', 'Generating Attention, Inhibition, and Memory', 'parent ratings of emotional control', 'objective EF measures', 'parent ratings of inattention, hyperactivity/impulsivity, and number/severity of problems experienced in various home situations, teacher ratings of severity of problems in various school situations, parent and teacher ratings of overall impairment, and clinician ratings of impairment', 'initial feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0808517,"No effect of the intervention was observed on the objective EF measures, although parent ratings of emotional control were improved for children in the intervention group.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""a Behavioral Medicine and Clinical Psychology , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""a Behavioral Medicine and Clinical Psychology , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Richard E A', 'Initials': 'REA', 'LastName': 'Loren', 'Affiliation': ""a Behavioral Medicine and Clinical Psychology , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Becker', 'Affiliation': ""a Behavioral Medicine and Clinical Psychology , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Brenner', 'Affiliation': 'b College of Humanities and Social and Behavioral Sciences , Central Michigan University.'}, {'ForeName': 'Morgan E', 'Initials': 'ME', 'LastName': 'Bamberger', 'Affiliation': ""c Communication Science Research Center , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""a Behavioral Medicine and Clinical Psychology , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Halperin', 'Affiliation': 'd The Graduate Center Psychology Program, Queens College , City University of New York.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1266645']
206,28278597,A Digital Feedback System to Support Implementation of Measurement-Based Care by School-Based Mental Health Clinicians.,"Evidence supports the utility of measurement-based care (MBC) to improve youth mental health outcomes, but clinicians rarely engage in MBC practices. Digital measurement feedback systems (MFS) may reflect a feasible strategy to support MBC adoption and sustainment. This pilot study was initiated to evaluate the impact of a MFS and brief consultation supports to facilitate MBC uptake and sustainment among mental health clinicians in the education sector, the most common mental health service delivery setting for youth. Following an initial training in MBC, 14 clinicians were randomized to either a digital MFS and brief consultation supports or control. Baseline ratings of MBC attitudes, skill, and use were collected. In addition, daily assessment ratings tracked 2 core MBC practices (i.e., assessment tool administration, provision of feedback) over a 6-month follow-up period. Clinicians in the MFS condition demonstrated rapid increases in both MBC practices, whereas the control group did not significantly change. For clinicians in the MFS group, consultation effects were significant for feedback and approached significance for administration. Over the follow-up period, average decreases in the current study were moderate with only 1 of the 2 outcome variables (administration) decreasing significantly. Inspection of individual clinician trajectories revealed substantial within-group trend variation. MFS may represent an effective MBC implementation strategy beyond initial training, although individual clinician response is variable. Identifying feasible and impactful implementation strategies is critical given the ability of MBC to support precision health care.",2019,"Clinicians in the MFS condition demonstrated rapid increases in both MBC practices, whereas the control group did not significantly change.",['youth'],"['digital MFS and brief consultation supports or control', 'Digital measurement feedback systems (MFS', 'measurement-based care (MBC']","['Baseline ratings of MBC attitudes, skill, and use']","[{'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",14.0,0.04461,"Clinicians in the MFS condition demonstrated rapid increases in both MBC practices, whereas the control group did not significantly change.","[{'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'a Department of Psychiatry and Behavioral Health Sciences , University of Washington.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pullmann', 'Affiliation': 'a Department of Psychiatry and Behavioral Health Sciences , University of Washington.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Whitaker', 'Affiliation': 'a Department of Psychiatry and Behavioral Health Sciences , University of Washington.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Ludwig', 'Affiliation': 'a Department of Psychiatry and Behavioral Health Sciences , University of Washington.'}, {'ForeName': 'Jessica Knaster', 'Initials': 'JK', 'LastName': 'Wasse', 'Affiliation': 'b Public Health - Seattle & King County , Seattle , WA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'a Department of Psychiatry and Behavioral Health Sciences , University of Washington.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2017.1280808']
207,31168085,Mucosal lactoferrin response to genital tract infections is associated with iron and nutritional biomarkers in young Burkinabé women.,"BACKGROUND/OBJECTIVES


The iron-binding affinity of vaginal lactoferrin (Lf) reduces iron available to genital pathogens. We describe host reproductive, nutritional, infection and iron biomarker profiles affecting vaginal Lf concentration in young nulliparous and primigravid women in Burkina Faso.
SUBJECTS/METHODS


Vaginal eluates from women who had participated in a randomized, controlled periconceptional iron supplementation trial were used to measure Lf using a competitive double-sandwich ELISA. For this analysis samples from both trial arms were combined and pregnant and non-pregnant cohorts compared. Following randomization Lf was measured after 18 months (end assessment) for women remaining non-pregnant, and at two antenatal visits for those becoming pregnant. Associations between log Lf levels and demographic, anthropometric, infection and iron biomarker variables were assessed using linear mixed models.
RESULTS


Lf samples were available for 712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit. Lf concentrations of pregnant women were comparable to those of non-pregnant, sexually active women. Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV. Adjusted Lf concentration was positively associated with serum hepcidin (P = 0.047), serum ferritin (P = 0.018) and total body iron stores (P = 0.042). There was evidence that some women maintained persistently high or low Lf concentrations from before, and through, pregnancy.
CONCLUSION


Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses.",2019,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","['young nulliparous and primigravid women in Burkina Faso', '712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit', 'pregnant women', 'young Burkinabé women', 'Vaginal eluates from women who had participated']",[],"['Lf concentration', 'Adjusted Lf concentration', 'log Lf levels and demographic, anthropometric, infection and iron biomarker variables', 'Mucosal lactoferrin response', 'Lf concentrations', 'Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses', 'serum hepcidin', 'serum C-reactive protein', 'serum ferritin', 'body mass index', 'total body iron stores', 'Trichomonas vaginalis']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0301870', 'cui_str': 'Eluate'}]",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0729552', 'cui_str': 'Infectious disease of genitopelvic system'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1561987', 'cui_str': 'Homeostatic mechanism'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}]",,0.0939264,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brabin', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium and Medical Mission Institute, Würzburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nelson', 'Affiliation': 'Faculty of Health and Life Sciences, University of Northumbria, Northumberland Building, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Swinkels', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Geurts-Moespot', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kazienga', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit (MRC), Fajara, The Gambia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine, and Institute of Infection and Global Health, University of Liverpool, Liverpool, UK. b.j.brabin@liverpool.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0444-7']
208,31952851,Is It Time for a Randomized Controlled Trial of Hypothermia for Mild Hypoxic-Ischemic Encephalopathy?,,2020,,[],['Hypothermia'],[],[],"[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]",[],,0.157476,,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'Sara V', 'Initials': 'SV', 'LastName': 'Bates', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI. Electronic address: sshankar@med.wayne.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.11.030']
209,32151851,A calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime to reduced blood pressure variability in acute ischaemic stroke (CAARBS): A feasibility trial.,"BACKGROUND


Trials of lowering blood pressure in patients with acute ischaemic stroke not undergoing thrombolysis have not demonstrated improved outcomes with intervention. Rather than absolute levels, it may be that blood pressure variability is important. However, there are no prospective randomised trials investigating the benefit of reducing blood pressure variability in this patient group.
AIMS


The primary aim of this trial was to determine the feasibility of recruitment to a randomised trial investigating the effect of different antihypertensive medications on blood pressure variability.
METHODS


CAARBS was a multi-centre, open-label, randomised parallel group controlled feasibility trial. Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention, were randomised to a calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Blood pressure and variability were measured at baseline, three weeks, and three months. Compliance with measurements and treatment was monitored.
RESULTS


Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up. The majority of patients screened (98.1%) were ineligible. Compliance with the intervention was good, as were measurement completion rates (88.9% or higher in all cases except ambulatory measurements). No major adverse events were recorded.
CONCLUSIONS


Recruitment to the trial was difficult due to patient ineligibility, suggesting that the current protocol is unlikely to be successful if scaled for a definitive trial. However, the intervention was safe, and compliance was good, suggesting a future trial with modified eligibility criteria could be successful.
TRIAL REGISTRATION


ISRCTN10853487.",2020,"No major adverse events were recorded.
","['patients with acute ischaemic stroke not undergoing thrombolysis', 'Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention', 'acute ischaemic stroke (CAARBS', 'Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up']","['calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker', 'calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime', 'antihypertensive medications']","['Blood pressure and variability', 'blood pressure variability', 'major adverse events', 'measurement completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",14.0,0.278614,"No major adverse events were recorded.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK. Electronic address: willdavison@doctors.org.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Appiah', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; NIHR Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Iain J', 'Initials': 'IJ', 'LastName': 'McGurgan', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116753']
210,31368422,"High calcium intake from fat-free milk, body composition and glycaemic control in adults with type 2 diabetes: a randomised crossover clinical trial.","We evaluated the effects of high-Ca fat-free milk v. low-Ca control diet on adiposity and on glycaemic control. Fourteen subjects with type 2 diabetes (aged 49·5 (sd 8·6) years, BMI 29·4 (sd 4·5) kg/m2, low habitual Ca consumption (<600 mg/d)) were included in this randomised, crossover clinical trial. Subjects participated in two 12-week experimental sessions (high-Ca fat-free milk (HC) or low-Ca control (LC)) separated by 8-week washout. Subjects daily consumed in the laboratory a breakfast shake containing 700 mg (HC) or 6·4 mg (LC) of Ca. Energy-restricted diets containing 800 mg of dietary Ca/d were prescribed. Dietary records data indicated the consumption of 1200 mg of Ca/d during HC and of 525 mg of Ca/d during LC. There was a greater reduction in body weight, body fat mass, waist circumference and waist:hip ratio after HC. Serum 25-hydoxyvitamin D and homeostatic model assessment-2 β-cell function (HOMA2-%B) increased, and serum uric acid, parathormone (PTH) and glycated Hb (HbA1c) concentrations reduced after HC. In addition, changes from baseline in terms of serum uric acid, glucose, HbA1c and PTH concentrations were lower, and those of HOMA2-%B, serum Ca and 25-hydoxyvitamin D were higher after the HC than after LC. The consumption of approximately three servings of fat-free milk and 1200 mg of dietary Ca/d enhanced weight loss, improved body composition and promoted glycaemic control in subjects with type 2 diabetes and low habitual Ca consumption (<600 mg/d).",2019,"In addition, changes from baseline in terms of serum uric acid, glucose, HbA1c and PTH concentrations were lower, and those of HOMA2-%B, serum Ca and 25-hydoxyvitamin D were higher after the HC than after LC.","['adults with type 2 diabetes', 'subjects with type 2 diabetes', 'Fourteen subjects with type 2 diabetes (aged 49·5 (sd 8·6) years, BMI 29·4 ', 'sd 4·5']","['high-Ca fat-free milk v. low-Ca control diet', 'breakfast shake containing 700 mg (HC) or 6·4 mg (LC) of Ca', 'experimental sessions (high-Ca fat-free milk (HC) or low-Ca control (LC']","['adiposity and on glycaemic control', 'serum uric acid, glucose, HbA1c and PTH concentrations', 'weight loss, improved body composition and promoted glycaemic control', 'body weight, body fat mass, waist circumference and waist:hip ratio', 'Serum 25-hydoxyvitamin D and homeostatic model assessment-2 β-cell function (HOMA2-%B) increased, and serum uric acid, parathormone (PTH) and glycated Hb (HbA1c) concentrations', 'HOMA2-%B, serum Ca and 25-hydoxyvitamin D', 'low habitual Ca consumption ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",14.0,0.0180117,"In addition, changes from baseline in terms of serum uric acid, glucose, HbA1c and PTH concentrations were lower, and those of HOMA2-%B, serum Ca and 25-hydoxyvitamin D were higher after the HC than after LC.","[{'ForeName': 'Júnia Maria Geraldo', 'Initials': 'JMG', 'LastName': 'Gomes', 'Affiliation': 'Instituto Federal do Sudeste de Minas Gerais - Campus Barbacena, Rua Monsenhor José Augusto, 204, Bairro São José, Barbacena, Minas Gerais CEP 36205-018, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'de Assis Costa', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, Minas Gerais CEP 36570-000, Brazil.'}, {'ForeName': 'Priscila Vaz de Melo', 'Initials': 'PVM', 'LastName': 'Ribeiro', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, Minas Gerais CEP 36570-000, Brazil.'}, {'ForeName': 'Rita de Cássia Gonçalves', 'Initials': 'RCG', 'LastName': 'Alfenas', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Avenida PH Rolfs, s/n, Viçosa, Minas Gerais CEP 36570-000, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519001259']
211,32331363,Twelve-month Studies on  Perilla  Oil Intake in Japanese Adults-Possible Supplement for Mental Health.,"Perilla  oil (PO), rich in α-linolenic acid (LNA, C18:3, ω-3), is increasingly alleged to have numerous health benefits in humans. However, the current reports detailing the effects of PO on human mental health are not adequate. Therefore, in the current investigation we compared the effects of PO or placebo treatment on the mental condition of healthy adult Japanese volunteers. At baseline and after 12 months of treatment, mental health condition was assessed using the Zung Self-Rating Depression Scale (SDS) and Apathy Scale, and serum biochemical parameters were determined. From baseline to 12 months of intervention, both SDS depression and apathy scores improved significantly in the PO-administered group. Compared to those of control group, serum norepinephrine and serotonin levels after 12 months decreased in the PO-administered group. The enhanced mental state observed in PO-subjects was accompanied by LNA level increases in erythrocyte plasma membranes. Our data demonstrate that PO intake enhances blood LNA levels and may maintain healthy mental conditions in adult subjects.",2020,"From baseline to 12 months of intervention, both SDS depression and apathy scores improved significantly in the PO-administered group.","['Japanese Adults-Possible Supplement for Mental Health', 'adult subjects', 'healthy adult Japanese volunteers']","['placebo', 'PO', 'Perilla  Oil Intake', 'Perilla  oil (PO']","['SDS depression and apathy scores', 'Zung Self-Rating Depression Scale (SDS) and Apathy Scale, and serum biochemical parameters', 'erythrocyte plasma membranes', 'blood LNA levels', 'enhanced mental state', 'mental health condition', 'serum norepinephrine and serotonin levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070421', 'cui_str': 'perilla seed oil'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0007603', 'cui_str': 'Cell membrane'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0765942', 'cui_str': 'latent nuclear antigen (LNA)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0202217', 'cui_str': 'Serotonin measurement'}]",,0.0324338,"From baseline to 12 months of intervention, both SDS depression and apathy scores improved significantly in the PO-administered group.","[{'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo 693-8501, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo 693-8501, Japan.'}, {'ForeName': 'Setsushi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation, Kawamoto, Shimane 696-0001, Japan.'}, {'ForeName': 'Shahdat', 'Initials': 'S', 'LastName': 'Hossain', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo 693-8501, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Ohno', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation, Kawamoto, Shimane 696-0001, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shido', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo 693-8501, Japan.'}]","Foods (Basel, Switzerland)",['10.3390/foods9040530']
212,32120028,Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes.,"BACKGROUND


Thyroid hormone promotes remyelination in multiple sclerosis (MS) animal models through a variety of mechanisms. Liothyronine (L-T3) is a short-acting thyroid hormone with demonstrated safety and tolerability for short-term and chronic use in euthyroid adults with other health conditions, but has not been studied in people with MS. The objectives of this single-center, phase I, placebo-controlled, clinical trial were to determine the safety, tolerability, and optimal dosing of L-T3 in people with MS in preparation for a phase 2 remyelination clinical trial. Secondary goals included exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week.
METHODS


Groups of six clinically stable people with MS were randomized in a 4:2 ratio to receive L-T3 or placebo. The first group received 50 mcg total daily dose (TDD) of L-T3, with escalating doses of L-T3 in subsequent groups, up to potentially 150 mcg TDD in the final group. Prior to enrollment for the next dose-escalated group, all safety measures for the prior dose were reviewed. The maximum tolerated dose (MTD) was considered to be the dose below which two or more participants experienced dose limiting symptoms or one participant experienced a serious adverse event. After the MTD was reached, no further patients were enrolled. Visual evoked potentials (VEP) P100 latency with two different check sizes (17' and 34') and Sloan low contrast letter acuity (LCLA) were measured pre- and post-treatment. To determine whether there was a treatment effect, the placebo and L-T3 groups were compared using a clustered bootstrap regression estimation. A linear mixed effects model was used to determine test-retest reliability of VEP and LCLA in all eyes.
RESULTS


Between May 2016 and November 2016, 15 people with MS were randomized to L-T3 (n = 10) or placebo (n = 5). Subjects were adherent to the study drug and the MTD was 75 mcg TDD. No serious adverse events were observed and the most common adverse events were poor sleep and loose stools. No treatment effect of L-T3 was observed over one week. Therefore, data from patients on L-T3 and placebo were pooled to explore VEP and LCLA reliability. The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively. The mean differences in values between visits 1 and 2 for VEP 17' and 34' and LCLA were 1.9 ms/eye (SD 6.5), 0.4 ms/eye (6.3), and 0.8/eye (3.6), respectively.
CONCLUSIONS


This study confirms the short-term safety and tolerability of L-T3 in people with MS, with 75 mcg TDD as the MTD. Our results also support that, despite small variations over one week, VEP with various check sizes and Sloan LCLA are reliable functional and clinical outcome measures that could be used in remyelination clinical trials in MS. A future phase 2 clinical trial to investigate the efficacy of L-T3 as a remyelination therapy may be warranted. This trial was registered on clinicaltrials.gov (NCT02760056).",2020,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","['euthyroid adults with other health conditions', 'Groups of six clinically stable people with MS', 'people with MS in preparation for a phase 2 remyelination clinical trial', 'Between May 2016 and November 2016, 15 people with MS', 'people with MS, with 75 mcg TDD as the MTD', 'multiple sclerosis']","['Liothyronine (L-T3', '50 mcg total daily dose (TDD) of L-T3', 'L-T3', 'placebo', 'liothyronine', 'L-T3 or placebo']","['serious adverse events', 'Sloan low contrast letter acuity (LCLA', 'exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week', 'serious adverse event', 'Visual evoked potentials (VEP) P100 latency', 'VEP and LCLA reliability', 'safety and tolerability', 'maximum tolerated dose (MTD', 'safety, tolerability']","[{'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0334220', 'cui_str': 'Remyelination'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0042829', 'cui_str': 'Visual Pathways'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}]",15.0,0.117628,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Wooliscroft', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: wooliscr@ohsu.edu.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'Altowaijri', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: hildeand@ohsu.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Samuels', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, CR107, Portland, OR 97239, United States. Electronic address: samuelsm@ohsu.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: oken@ohsu.edu.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bourdette', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: bourdett@ohsu.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: cameromi@ohsu.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102015']
213,32330548,Motivational interviewing to prevent early childhood caries: A randomized controlled trial.,"OBJECTIVES


Prevailing health education (PE) often fails to achieve sustained behavioral changes. This randomized controlled trial integrated motivational interviewing (MI) and a patient communication tool featuring interactive caries risk assessment (RA) into PE and investigated the effectiveness of PE, PE + MI, and PE + MI + RA in preventing early childhood caries.
METHODS


This study targeted children aged 3-4 years with unfavorable oral health behaviors. 692 parent-child dyads were recruited, randomly assigned into three groups (PE, PE + MI, and PE + MI + RA), and received respective interventions. A questionnaire was completed at baseline and after 6 and 12 months to collect information on socio-demographic background, parental efficacy and children's oral health behaviors. Children's oral hygiene status and dental caries were recorded at baseline and after 12 months.
RESULTS


655 (94.7%) parent-child dyads remained in the study after 12 months. Caries increment was significantly lower in PE + MI group (β=-0.717, 95% CI: -1.035, -0.398) and PE + MI + RA group [β=-0.600, 95% CI: -0.793, -0.407] than in PE group. There was significantly greater reduction in plaque score in PE + MI group (β=-0.077, 95% CI: -0.106, -0.048) and PE + MI + RA group (β=-0.075, 95% CI: -0.113, -0.036), as compared with PE group. Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05). There was no significant difference between PE + MI group and PE + MI + RA group across all outcome measures (all p > 0.05).
CONCLUSIONS


Intergration of motivational interviewing improves the effectiveness of prevailing health education in preventing early childhood caries, enhancing parental efficacy, and improving children's oral health behaviors. Incorporation of the communication tool for caries risk assessment does not further improve the effectiveness of motivational interviewing in protecting children's oral health.
CLINICAL SIGNIFICANCE


The findings of this study provide much needed evidence for dentists, dental auxiliary staff and public health workers to select effective intervention to empower parents for improving children's oral health behaviors and preventing early childhood caries.",2020,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"['early childhood caries', '692 parent-child dyads', '655', 'children aged 3-4 years with unfavorable oral health behaviors']","['PE, PE\u2009+\u2009MI, and PE\u2009+\u2009MI\u2009+\u2009RA', 'motivational interviewing (MI) and a patient communication tool featuring interactive caries risk assessment (RA) into PE', 'Motivational interviewing']","[""Children's oral hygiene status and dental caries"", ""parental efficacy and children's oral health behaviors"", 'Caries increment', ""children's oral health behaviors"", 'plaque score']","[{'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0564415,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Edward Cm', 'Initials': 'EC', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Samuel My', 'Initials': 'SM', 'LastName': 'Ho', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Faculty of Dentistry & Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: dengx@nus.edu.sg.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103349']
214,32330571,Impact of the MTHFR C677T polymorphism on one-carbon metabolites: Evidence from a randomised trial of riboflavin supplementation.,"Homozygosity for the C677T polymorphism in MTHFR (TT genotype) is associated with a 24-87% increased risk of hypertension. Blood pressure (BP) lowering was previously reported in adults with the TT genotype, in response to supplementation with the MTHFR cofactor, riboflavin. Whether the BP phenotype associated with the polymorphism is related to perturbed one-carbon metabolism is unknown. This study investigated one-carbon metabolites and their responsiveness to riboflavin in adults with the TT genotype. Plasma samples from adults (n 115) screened for the MTHFR genotype, who previously participated in RCTs to lower BP, were analysed for methionine, S-adenosylmethionine (SAM), S-adenosylhomocysteine (SAH), betaine, choline and cystathionine by liquid chromatography tandem mass spectrometry (LC-MS/MS). The one-carbon metabolite response to riboflavin (1.6 mg/d; n 24) or placebo (n 23) for 16 weeks in adults with the TT genotype was also investigated. Plasma SAM (74.7 ± 21.0 vs 85.2 ± 22.6 nmol/L, P = 0.013) and SAM:SAH ratio (1.66 ± 0.55 vs 1.85 ± 0.51, P = 0.043) were lower and plasma homocysteine was higher (P = 0.043) in TT, compared to CC individuals. In response to riboflavin, SAM (P = 0.008) and cystathionine (P = 0.045) concentrations increased, with no responses in other one-carbon metabolites observed. These findings confirm perturbed one-carbon metabolism in individuals with the MTHFR 677TT genotype, and for the first time demonstrate that SAM, and cystathionine, increase in response to riboflavin supplementation in this genotype group. The genotype-specific, one-carbon metabolite responses to riboflavin intervention observed could offer some insight into the role of this gene-nutrient interaction in blood pressure.",2020,"In response to riboflavin, SAM (P = 0.008) and cystathionine (P = 0.045) concentrations increased, with no responses in other one-carbon metabolites.","['adults with the TT genotype', 'Plasma samples from adults (n 115) screened for the MTHFR genotype, who previously participated in RCTs to lower BP']","['riboflavin', 'riboflavin intervention', 'placebo', 'MTHFR C677T polymorphism']","['Plasma SAM', 'SAM', 'plasma homocysteine', 'Blood pressure (BP) lowering', 'risk of hypertension', 'SAH ratio']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.065837,"In response to riboflavin, SAM (P = 0.008) and cystathionine (P = 0.045) concentrations increased, with no responses in other one-carbon metabolites.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rooney', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: Rooney-m16@ulster.ac.uk.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Bottiglieri', 'Affiliation': 'Center of Metabolomics, Institute of Metabolic Disease, Baylor Scott & White Research Institute, 3812 Elm St, Dallas, TX, 75226, USA. Electronic address: Teodoro.Bottiglieri@BSWHealth.org.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Wasek-Patterson', 'Affiliation': 'Center of Metabolomics, Institute of Metabolic Disease, Baylor Scott & White Research Institute, 3812 Elm St, Dallas, TX, 75226, USA. Electronic address: Brandi.WasekPatterson@BSWHealth.org.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: am2663@medschl.cam.ac.uk.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Hughes', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: c.hughes@ulster.ac.uk.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'BEVITAL, Laboratoriebygget, 9 Etg, Jonas Lies Veg 87, 5021, Bergen, Norway. Electronic address: adrian.mccann@bevital.no.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Horigan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: gb.horigan@ulster.ac.uk.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Strain', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: jj.strain@ulster.ac.uk.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'McNulty', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: h.mcnulty@ulster.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Cromore Rd, Coleraine, BT52 1SA, Northern Ireland, UK. Electronic address: mw.ward@ulster.ac.uk.'}]",Biochimie,['10.1016/j.biochi.2020.04.004']
215,32330638,Comparative Efficacy of Vaginal Misoprostol vs Vaginal Dinoprostone Administered 3 Hours Prior to Copper T380A Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To compare the effectiveness of misoprostol and dinoprostone tablets administered vaginally 3 hours before copper intrauterine device (IUD) insertion vs placebo in reducing pain and increasing ease of insertion among nulliparous women.
DESIGN


Randomized controlled trial.
SETTING


Tertiary referral hospital.
PARTICIPANTS


A total of 129 nulliparous women requesting a Copper T380A IUD insertion.
INTERVENTIONS


Women were randomized to receive 200 μg misoprostol or 3 mg dinoprostone or placebo 3 hours before IUD insertion.
MAIN OUTCOME MEASURE(S)


Primary outcome was patient-reported pain during IUD insertion using a 10-cm visual analog scale (VAS). Secondary outcomes include provider ease of insertion, women satisfaction level, and side effects.
RESULTS


Participants' baseline characteristics were comparable between the study groups. Mean pain score during IUD insertion was lower with misoprostol than placebo (3.1 ± 2.3 vs 4.4 ± 2.2; P = .02) and dinoprostone compared to placebo (2.4 ± 1.8 vs 4.4 ± 2.2; P < .001). Clinicians reported easier IUD insertion with misoprostol than placebo (2.4 ± 1.7 vs 4.0 ± 2.4; P = .001) and dinoprostone compared to placebo (2.0 ± 1.5 vs 4.0 ± 2.4; P < .001). Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo (P < .001). Side effects did not differ among the 3 study groups.
CONCLUSIONS


Premedication with vaginal misoprostol or dinoprostone effectively lowered pain during copper IUD insertion. However, the reduction in pain scores was clinically significant only in women who received dinoprostone. In both the misoprostol and dinoprostone groups, clinicians found the procedure easier, and women were more satisfied with IUD insertion. Side effects and complications were similar in all groups.",2020,Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo(p<0.001).,"['Tertiary referral hospital', 'nulliparous women', '129 nulliparous women requesting a', 'Nulliparous Women']","['dinoprostone', 'Copper T380A', 'copper T380A IUD insertion', 'copper intrauterine device (IUD) insertion versus placebo', 'dinoprostone or placebo', 'Vaginal Misoprostol', 'misoprostol and dinoprostone tablets', 'Intrauterine Device Insertion', 'Vaginal Dinoprostone', 'misoprostol', 'vaginal misoprostol or dinoprostone']","['Side effects and complications', 'Mean pain score', 'satisfaction levels', 'patient-reported pain during IUD insertion using a 10 cm visual analog scale (VAS', 'provider ease of insertion, women satisfaction level, and side effects', 'Side effects', 'pain scores', 'pain']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",129.0,0.864163,Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo(p<0.001).,"[{'ForeName': 'Ahmed Samy Ali', 'Initials': 'ASA', 'LastName': 'Ashour', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmedsamy8233@outlook.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Sharkawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Histology Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Nawal Hamdy Ahmed', 'Initials': 'NHA', 'LastName': 'Keshta', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hanan Barakat Abu Elyazid', 'Initials': 'HBAE', 'LastName': 'Shatat', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2020.04.004']
216,31096264,Influence of Δ9-tetrahydrocannabinol on long-term neural correlates of threat extinction memory retention in humans.,"The neural mechanisms and durability of Δ9-tetrahydrocannabinol (THC) impact on threat processing in humans are not fully understood. Herein, we used functional MRI and psychophysiological tools to examine the influence of THC on the mechanisms of conditioned threat extinction learning, and the effects of THC on extinction memory retention when assessed 1 day and 1 week from learning. Healthy participants underwent threat conditioning on day 1. On day 2, participants were randomized to take one pill of THC or placebo (PBO) 2-h before threat extinction learning. Extinction memory retention was assessed 1 day and 1 week after extinction learning. We found that THC administration increased amygdala and ventromedial prefrontal cortex (vmPFC) activation during early extinction learning with no significant impact on skin conductance responses (SCR). When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network. When extinction memory retention was tested 1 week after learning, the THC group exhibited significantly decreased responses to the extinguished cues within the vmPFC and amygdala, but significantly increased functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex during this extinction retention test. Our results are the first to report a long-term impact of one dose of THC on the functional activation of the threat extinction network and unveil a significant change in functional connectivity emerging after a week from engagement. We highlight the need for further investigating the long-term impact of THC on threat and anxiety circuitry.",2019,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","['humans', 'Healthy participants underwent threat conditioning on day 1']","['Δ9-tetrahydrocannabinol (THC', 'THC', 'Δ9-tetrahydrocannabinol', 'THC or placebo (PBO) 2-h before threat extinction learning']","['extinction memory retention', 'amygdala and ventromedial prefrontal cortex (vmPFC) activation', 'Extinction memory retention', 'functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex', 'skin conductance responses (SCR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0325937,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","[{'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA. mhammoud@uic.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Joshua R B', 'Initials': 'JRB', 'LastName': 'Hatfield', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0416-6']
217,31177994,A self-help diet and physical activity intervention with dietetic support for weight management in men treated for prostate cancer: pilot study of the Prostate Cancer Weight Management (PRO-MAN) randomised controlled trial.,"Overweight and obesity may increase risk of disease progression in men with prostate cancer, but there have been few studies of weight loss interventions in this patient group. In this study overweight or obese men treated for prostate cancer were randomised to a self-help diet and activity intervention with telephone-based dietitian support or a wait-list mini-intervention group. The intervention group had an initial group meeting, a supporting letter from their urological consultant, three telephone dietitian consultations at 4-week intervals, a pedometer and access to web-based diet and physical activity resources. At 12 weeks, men in both groups were given digital scales for providing follow-up weight measurements, and the wait-list group received a mini-intervention of the supporting letter, a pedometer and access to the web-based resources. Sixty-two men were randomised; fifty-four completed baseline and 12-week measurements, and fifty-one and twenty-seven provided measurements at 6 and 12 months, respectively. In a repeated-measures model, mean difference in weight change between groups (wait-list mini-intervention minus intervention) at 12 weeks was -2·13 (95 % CI -3·44, -0·82) kg (P = 0·002). At 12 months the corresponding value was -2·43 (95 % CI -4·50, -0·37) kg (P = 0·022). Mean difference in global quality of life score change between groups at 12 weeks was 12·3 (95 % CI 4·93, 19·7) (P = 0·002); at 12 months there were no significant differences between groups. Results suggest the potential of self-help diet and physical activity intervention with trained support for modest but sustained weight loss in this patient group.",2019,Mean (95 % CI) difference in global QoL score change between groups at 12 weeks was 12·3,"['Sixty-two men', 'men with prostate cancer', 'Men treated for prostate cancer who were overweight or obese', 'men treated for prostate cancer']","['self-help diet and physical activity intervention with telephone-based dietitian support', 'mini-intervention of the supporting letter, a pedometer and access to the web-based resources', 'self-help diet and physical activity intervention with dietetic support', 'initial group meeting, a supporting letter from their urological consultant, three telephone dietitian consultations at 4-week intervals, a pedometer and access to web-based diet and physical activity resources', 'intervention or wait-list mini-intervention groups']","['sustained weight loss', 'weight change', 'global QoL score change']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",62.0,0.0769516,Mean (95 % CI) difference in global QoL score change between groups at 12 weeks was 12·3,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mohamad', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ntessalen', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'L C A', 'Initials': 'LCA', 'LastName': 'Craig', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': 'NHS Grampian Department of Nutrition and Dietetics, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fielding', 'Affiliation': 'Medical Statistics Team, Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Academic Urology Unit, Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Heys', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McNeill', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK.'}]",The British journal of nutrition,['10.1017/S0007114519001090']
218,31982605,"A Randomized, Placebo-Controlled, Double-Blind Study of Minocycline for Reducing the Symptom Burden Experienced by Patients With Advanced Pancreatic Cancer.","CONTEXT


Although it is well known that patients with advanced pancreatic cancer (PC) experience significant symptom burden, few strategies for effective symptom intervention are available for them.
OBJECTIVES


To investigate the efficacy of minocycline, an anti-inflammatory agent, for symptom reduction in patients with advanced PC.
METHODS


We conducted Phase II, randomized, and placebo-controlled trial to obtain preliminary estimates of the effects on symptom reduction with 100 mg of minocycline or placebo given twice a day. Eligible patients had diagnosed advanced PC and were scheduled for standard chemotherapy. Patient-reported symptoms were measured weekly during the eight-week trial using the MD Anderson Symptom Inventory (MDASI) module in patients with gastrointestinal cancer. The primary outcome measure was the area under the curve values of the five most severe symptoms in the two arms.
RESULTS


Of the 44 patients recruited, 31 (71%) were evaluable for the primary efficacy analysis, with 18 received minocycline and 13 placebo. Fatigue, pain, disturbed sleep, lack of appetite, and drowsiness were the most severe symptoms reported by both groups. No significant differences in area under the curve values over time between the study arms were found for the composite MDASI score or single-item scores of the five most severe MDASI items. No treatment-related deaths were reported, and no Grade 3-4 toxicities were observed.
CONCLUSION


Minocycline is safe for use in patients receiving treatment for PC. There is no observed symptom reduction with minocycline on the major symptom burden associated with advanced PC compared with placebo. Attrition because of rapid disease progression impacted the study significantly.",2020,No significant differences in AUC values over time between the study arms were found for the composite MDASI score or single-item scores of the 5 most-severe MDASI items.,"['patients receiving treatment for PC', 'Patients with Advanced Pancreatic Cancer', 'Eligible patients had diagnosed advanced PC and were scheduled for standard chemotherapy', 'advanced PC patients', '44 patients recruited, 31 (71', 'patients with gastrointestinal cancer (MDASI-GI', 'patients with advanced pancreatic cancer (PC']","['Placebo', 'minocycline', 'Minocycline', 'placebo', 'minocycline or placebo']","['AUC values', 'grade 3-4 toxicities', 'composite MDASI score or single-item scores', 'area under the curve (AUC) values of the 5 most-severe symptoms', 'Fatigue, pain, disturbed sleep, lack of appetite, and drowsiness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}]",44.0,0.329015,No significant differences in AUC values over time between the study arms were found for the composite MDASI score or single-item scores of the 5 most-severe MDASI items.,"[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Xin Shelley', 'Initials': 'XS', 'LastName': 'Wang', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: xswang@mdanderson.org.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Mendoza', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Garcia-Gonzalez', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Raza H', 'Initials': 'RH', 'LastName': 'Bokhari', 'Affiliation': 'Department of GI Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Fogelman', 'Affiliation': 'Department of GI Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.007']
219,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


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


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


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


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
220,32333328,The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.,"INTRODUCTION


A fixed dose combination (FDC) of ibuprofen 400 mg and caffeine 100 mg has been shown to be more effective than ibuprofen 400 mg alone for the treatment of acute postoperative dental pain in a phase III randomised controlled trial. A post hoc subgroup analysis of the primary data from an active-/placebo-controlled, double-blind, single-centre, parallel-group study was conducted in patients with moderate or severe baseline pain.
METHODS


After dental surgery, patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain'), received a single dose of ibuprofen 400 mg/caffeine 100 mg FDC, ibuprofen 400 mg, caffeine 100 mg or placebo. Pain relief (PAR) and pain intensity were assessed 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 h after administration of study medication. The primary study endpoint was the time-weighted sum of PAR and pain intensity difference (PID) from pre-dose baseline, summed for all post-dose assessment times from 0 to 8 h (SPRID 0-8h ).
RESULTS


There were 237 patients with moderate pain and 325 with severe pain at baseline. SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups. Adjusted mean SPRID 0-8h  difference for the FDC versus ibuprofen was 18.19 (p < 0.0001) for patients with moderate pain and 7.70 (p = 0.0409) for patients with severe pain. With the exception of the 7-h measurement in patients with moderate pain, PID was significantly improved with the FDC versus ibuprofen at all measured time points from 0.5 to 8 h. In the severe pain subgroup, PID was significantly improved for the FDC versus ibuprofen from 0.5 to 3 h post-dose, but was not significantly different thereafter.
CONCLUSION


The enhanced analgesic efficacy of ibuprofen/caffeine FDC versus ibuprofen is most pronounced in patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01929031.",2020,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","['patients with moderate or severe baseline pain', ""patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain"", '237 patients with moderate pain and 325 with severe pain at baseline', 'Patients with Acute Postoperative Dental Pain', 'patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain']","['ibuprofen', 'ibuprofen 400\xa0mg and caffeine', 'FDC versus ibuprofen, caffeine and placebo', 'ibuprofen/caffeine FDC versus ibuprofen', 'Ibuprofen/Caffeine', 'FDC versus ibuprofen', 'ibuprofen 400\xa0mg/caffeine 100\xa0mg FDC, ibuprofen 400\xa0mg, caffeine 100\xa0mg or placebo']","['analgesic efficacy', 'Pain relief (PAR) and pain intensity', 'moderate pain, PID', 'PID', 'time-weighted sum of PAR and pain intensity difference (PID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0984276', 'cui_str': 'Caffeine 100 MG'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",237.0,0.652098,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Förderreuther', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians University, Munich, Germany. sfoerder@med.uni-muenchen.de.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lampert', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Global Medical Consumer Health Care, Sanofi-Aventis Groupe, Gentilly, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weiser', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01297-y']
221,32297719,"Efficacy and Safety of Guanfacine Extended-Release in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled Study.","OBJECTIVE


To assess guanfacine extended-release (GXR) efficacy and safety in adults with attention-deficit/hyperactivity disorder (ADHD).
METHODS


This phase 3, double-blind, placebo-controlled study (conducted between October 2016 and July 2017) included Japanese patients aged ≥ 18 years with ADHD (DSM-5). Patients received GXR (n = 101) or placebo (n = 100) titrated from 2 mg/d to 4-6 mg/d (dose-optimization; 5 weeks), followed by 4-6 mg/d (dose-maintenance; 5 weeks), then tapered doses to 2 mg/d (2 weeks). Primary endpoint was change from baseline in total score on the Japanese version of the ADHD-Rating Scale IV with adult prompts (ADHD-RS-IV) at week 10. Other measures were ADHD-RS-IV subscales, Clinical Global Impression-Improvement scale (CGI-I) and Patient Global Impression-Improvement scale (PGI-I) (percentage of patients very much improved/much improved), treatment-emergent adverse event (TEAE) incidences, and TEAEs leading to discontinuation.
RESULTS


Compared with placebo, there was statistically significantly greater improvement in ADHD-RS-IV total score reduction with GXR (least squares mean ± SE: GXR vs placebo, -11.55 ± 1.10 vs -7.27 ± 1.07; P = .0005; effect size 0.52). There were significantly greater improvements in GXR for ADHD-RS-IV inattention (-7.39 ± 0.79 vs -4.89 ± 0.76; P = .0032) and hyperactivity-impulsivity (-3.84 ± 0.54 vs -2.10 ± 0.52; P = .0021) subscale scores, CGI-I scores (48.1% vs 22.6%; P = .0007), and PGI-I scores (25.3% vs 11.8%; P = .0283). More patients in the GXR versus the placebo group reported TEAEs (81.2% vs 62.0%) and discontinued due to TEAEs (19.8% vs 3.0%). The main TEAEs in the GXR group were somnolence, thirst, blood pressure decrease, nasopharyngitis, postural dizziness, and constipation; most TEAEs were mild to moderate in severity.
CONCLUSIONS


In Japanese adults with ADHD, GXR improved ADHD symptoms without any major safety concerns.
Trial Registration


Japan Primary Registries Network (https://rctportal.niph.go.jp/en): JapicCTI-163231",2020,"There were significantly greater improvements in GXR for ADHD-RS-IV inattention (-7.39 ± 0.79 vs -4.89 ± 0.76; P = .0032) and hyperactivity-impulsivity (-3.84 ± 0.54 vs -2.10 ± 0.52; P = .0021) subscale scores, CGI-I scores (48.1% vs 22.6%; P = .0007), and PGI-I scores (25.3% vs 11.8%; P = .0283).","['Attention-Deficit/Hyperactivity Disorder in Adults', 'Japanese adults with ADHD', 'adults with attention-deficit/hyperactivity disorder (ADHD', 'October 2016 and July 2017) included Japanese patients aged ≥ 18 years with ADHD (DSM-5']","['placebo', 'GXR', 'guanfacine', 'Placebo', 'Guanfacine']","['Efficacy and Safety', 'ADHD-RS-IV total score reduction with GXR', 'hyperactivity-impulsivity', 'ADHD symptoms', 'total score on the Japanese version of the ADHD-Rating Scale IV with adult prompts (ADHD-RS-IV', 'release (GXR) efficacy and safety', 'somnolence, thirst, blood pressure decrease, nasopharyngitis, postural dizziness, and constipation', 'subscale scores, CGI-I scores', 'GXR for ADHD-RS-IV inattention', 'ADHD-RS-IV subscales, Clinical Global Impression-Improvement scale (CGI-I) and Patient Global Impression-Improvement scale (PGI-I', 'PGI-I scores']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0234987', 'cui_str': 'Postural dizziness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.2441,"There were significantly greater improvements in GXR for ADHD-RS-IV inattention (-7.39 ± 0.79 vs -4.89 ± 0.76; P = .0032) and hyperactivity-impulsivity (-3.84 ± 0.54 vs -2.10 ± 0.52; P = .0021) subscale scores, CGI-I scores (48.1% vs 22.6%; P = .0007), and PGI-I scores (25.3% vs 11.8%; P = .0283).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwanami', 'Affiliation': 'Department of Psychiatry, Showa University School of Medicine, 6-11-11 Kita Karasuyama, Setagaya-ku, Tokyo, 157-8577, Japan. iwanami@med.showa-u.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Aiiku Counselling Office, Aiiku Research Institute, Imperial Gift Foundation Boshi-Aiiku-Kai, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Biostatistics Center, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Okutsu', 'Affiliation': 'Clinical Research Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Japan Developmental Disorders Network, Tokyo, Japan.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12979']
222,31468735,Promoting social attention in 3-year-olds with ASD through gaze-contingent eye tracking.,"Young children with autism spectrum disorder (ASD) look less toward faces compared to their non-ASD peers, limiting access to social learning. Currently, no technologies directly target these core social attention difficulties. This study examines the feasibility of automated gaze modification training for improving attention to faces in 3-year-olds with ASD. Using free-viewing data from typically developing (TD) controls (n = 41), we implemented gaze-contingent adaptive cueing to redirect children with ASD toward normative looking patterns during viewing of videos of an actress. Children with ASD were randomly assigned to either (a) an adaptive Cue condition (Cue, n = 16) or (b) a No-Cue condition (No-Cue, n = 19). Performance was examined at baseline, during training, and post-training, and contrasted with TD controls (n = 23). Proportion of time looking at the screen (%Screen) and at actresses' faces (%Face) was analyzed. At Pre-Training, Cue and No-Cue groups did not differ in %Face (P > 0.1). At Post-Training, the Cue group had higher %Face than the No-Cue group (P = 0.015). In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group. These results suggest gaze-contingent training effectively mitigated decreases of attention toward the face of onscreen social characters in ASD. Additionally, larger training effects were observed in children with lower nonverbal ability, suggesting a gaze-contingent approach may be particularly relevant for children with greater cognitive impairment. This work represents development toward new social attention therapeutic systems that could augment current behavioral interventions. Autism Res 2020, 13: 61-73. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: In this study, we leverage a new technology that combines eye tracking and automatic computer programs to help very young children with ASD look at social information in a more prototypical way. In a randomized controlled trial, we show that the use of this technology prevents the diminishing attention toward social information normally seen in children with ASD over the course of a single experimental session. This work represents development toward new social attention therapeutic systems that could augment current behavioral interventions.",2020,In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group.,"['children with ASD', '3-year-olds with ASD', 'young children with ASD look at social information in a more prototypical way', 'Young children with autism spectrum disorder (ASD', 'Children with ASD']","['automated gaze modification training', 'adaptive Cue condition (Cue, n\u2009=\u200916) or (b) a No-Cue condition', 'implemented gaze-contingent adaptive cueing to redirect children with ASD toward normative looking patterns during viewing of videos of an actress', 'combines eye tracking and automatic computer programs']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}]",[],,0.0124381,In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group.,"[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Wall', 'Affiliation': 'Department of School Psychology, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Barney', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bradshaw', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Macari', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Chawarska', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Shic', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2199']
223,31132095,Optimizing Warnings on E-Cigarette Advertisements.,"INTRODUCTION


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


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


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


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


This study examines the impact of visual optimizations on recall of the US Food and Drug Administration-mandated e-cigarette advertisement warning text. We found that color might influence warning text recall, but we did not find effects for shape or signal word. It is possible the newly mandated e-cigarette advertisement warnings, which are required to occupy at least 20% of the advertisement, are currently novel enough to attract attention. Future research should examine optimizations following implementation of the new advertisement warnings.",2020,Those exposed to novel shape (44.7% novel vs 37.9% rectangle; p=.003) or color (44.5% BY vs 41.9% YB vs 37.5% BW; p=.04) warnings were more likely to report attention to the warning.,"['1854 young adult (18-34) e-cigarette users or susceptible non-users', 'participants to view one of 12 warnings on a fictional e-cigarette advertisement']","['visual optimizations', 'color (black text on white background [BW']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],1854.0,0.01347,Those exposed to novel shape (44.7% novel vs 37.9% rectangle; p=.003) or color (44.5% BY vs 41.9% YB vs 37.5% BW; p=.04) warnings were more likely to report attention to the warning.,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'King', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Ranney', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cornacchione Ross', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kimberly G', 'Initials': 'KG', 'LastName': 'Wagoner', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz091']
224,31201809,Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence.,"BACKGROUND


Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse.
OBJECTIVE


The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension.
STUDY DESIGN


This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected.
RESULTS


Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain.
CONCLUSION


Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.",2019,"Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs. 10.5%, p=0.043) but no difference in groin or thigh pain.
","['374 women randomized to receive uterosacral (n=188) or sacrospinous (n=186) vaginal vault suspension to treat both Stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers', 'patients receiving two common transvaginal prolapse repairs, uterosacral ligament and sacrospinous ligament vaginal vault suspension', 'pelvic organ prolapse and stress urinary incontinence']","['transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling', 'vaginal reconstructive surgery', 'transvaginal native tissue repairs and a midurethral sling', 'uterosacral or sacrospinous vaginal vault suspension and midurethral sling', 'perioperative pelvic muscle therapy or usual care', 'Uterosacral ligament suspension']","['Pain and activity', 'Surgical Pain Scales', 'narcotic pain medications', 'Pain during exercise/strenuous activity and worst pain', 'pain) and Activity Assessment Scale', 'Activity Assessment Scale', 'average pain at rest and during normal activity', 'Functional activity', 'new or worsening buttock pain', 'Bodily Pain, Physical Functioning and Role-Physical subscales', 'SF-36 Bodily Pain, Physical Functioning, and Role-Physical Scales', 'groin or thigh pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549115', 'cui_str': 'Structure of vaginal vault'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0549115', 'cui_str': 'Structure of vaginal vault'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0231710', 'cui_str': 'Pygalgia'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0222045'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain (finding)'}]",374.0,0.0856799,"Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs. 10.5%, p=0.043) but no difference in groin or thigh pain.
","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Barber', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham NC. Electronic address: matthew.barber@duke.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Brubaker', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California-San Diego, San Diego CA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Nygaard', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Wai', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas-Southwestern, Dallas TX.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ellington', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama-Birmingham, Birmingham AL.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Department of Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Department of Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.06.004']
225,31548349,Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance).,"PURPOSE


Previous studies have suggested that higher circulating 25-hydroxyvitamin D [25(OH)D] levels are associated with decreased colorectal cancer risk and improved survival. However, the influence of vitamin D status on disease progression and patient survival remains largely unknown for patients with advanced or metastatic colorectal cancer.
EXPERIMENTAL DESIGN


We prospectively collected blood samples in 1,041 patients with previously untreated advanced or metastatic colorectal cancer participating in a randomized phase III clinical trial of first-line chemotherapy plus biologic therapy. We examined the association of baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS). Cox proportional hazards models were used to calculate hazard ratios (HRs) and confidence intervals (CIs), adjusted for prognostic factors and confounders.
RESULTS


At study entry, 63% of patients were vitamin D deficient (<20 ng/mL) and 31% were vitamin D insufficient (20-<30 ng/mL). Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend  = 0.0009 and 0.03, respectively). Compared with patients in the bottom quintile of 25(OH)D (≤10.8 ng/mL), those in the top quintile (≥24.1 ng/mL) had a multivariable-adjusted HR of 0.66 (95% CI, 0.53-0.83) for OS and 0.81 (95% CI, 0.66-1.00) for PFS. The improved survival associated with higher 25(OH)D levels was consistent across patient subgroups of prognostic patient and tumor characteristics.
CONCLUSIONS


In this large cohort of patients with advanced or metastatic colorectal cancer, higher plasma 25(OH)D levels were associated with improved OS and PFS. Clinical trials assessing the benefit of vitamin D supplementation in patients with colorectal cancer are warranted.",2019,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","['Patients with Advanced or Metastatic Colorectal Cancer', 'CRC patients', '1,041 patients with previously untreated advanced or metastatic CRC participating in a randomized phase III clinical trial of first-line', 'patients with advanced or metastatic CRC']","['chemotherapy plus biologic therapy', 'vitamin D supplementation']","['colorectal cancer (CRC) risk and improved survival', 'survival', 'Plasma 25-Hydroxyvitamin D Levels and Survival', 'circulating 25-hydroxyvitamin D [25(OH)D] levels', 'OS and PFS', 'Higher 25(OH)D levels', 'baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS', 'plasma 25(OH)D levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1041.0,0.182611,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. chen_yuan@dfci.harvard.edu.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Chang', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, North Carolina.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy and Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Department of Medicine, University of California San Francisco (UCSF) School of Medicine, San Francisco, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0877']
226,32329963,"Comparison of the effects of three kinds of glucose-lowering drugs on non-alcoholic fatty liver disease in patients with type 2 diabetes: A randomized, open-label, three-arm, active control study.","AIMS/INTRODUCTION


Non-alcoholic fatty liver disease (NAFLD) is often observed in individuals with type 2 diabetes mellitus, and it is known that the presence of type 2 diabetes mellitus leads to the aggravation of NAFLD. The aim of this study was to compare the possible effects of three kinds of oral hypoglycemic agents on NAFLD in individuals with type 2 diabetes mellitus.
MATERIALS AND METHODS


We carried out a prospective clinical trial (a randomized and open-label study) in patients with type 2 diabetes mellitus and NAFLD. A total of 98 patients were randomly allocated either to the dapagliflozin (n = 32), pioglitazone (n = 33) or glimepiride (n = 33) group, and the patients took these drugs for 28 weeks. The primary end-point was the change of the liver-to-spleen ratio on abdominal computed tomography.
RESULTS


There was no difference in baseline clinical characteristics among the three groups. Dapagliflozin, pioglitazone and glimepiride ameliorated hyperglycemia similarly. Bodyweight and visceral fat area were significantly decreased only in the dapagliflozin group. Serum adiponectin levels were markedly increased in the pioglitazone group compared with the other two groups. Dapagliflozin and pioglitazone, but not glimepiride, significantly increased the liver-to-spleen ratio, and the effects of dapagliflozin and pioglitazone on the liver-to-spleen ratio were comparable.
CONCLUSIONS


The present study showed that the decrease of visceral fat area and the increase of adiponectin level contributed to the improvement of NAFLD in patients with type 2 diabetes mellitus. Furthermore, dapagliflozin and pioglitazone exerted equivalent beneficial effects on NAFLD in patients with type 2 diabetes mellitus, although it seemed that these two drugs had different mechanisms of action.",2020,"Dapagliflozin and pioglitazone, but not glimepiride, significantly increased L/S ratio, and the effects of dapagliflozin and pioglitazone on L/S ratio were comparable.
","['subjects with T2DM', 'subjects with type 2 diabetes mellitus (T2DM', 'subjects with T2DM and NAFLD', '98 subjects', 'cases with type 2 diabetes']","['glimepiride', 'pioglitazone', 'Dapagliflozin and pioglitazone', 'Dapagliflozin, pioglitazone and glimepiride', 'dapagliflozin and pioglitazone', 'oral hypoglycemic agents', 'dapagliflozin', 'glucose-lowering drugs']","['change of liver-to-spleen (L/S) ratio on abdominal computed tomography (CT', 'L/S ratio', 'adiponectin level', 'Body weight and visceral fat area (VFA', 'VFA', 'Serum adiponectin level', 'nonalcoholic fatty liver disease']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]",98.0,0.0181313,"Dapagliflozin and pioglitazone, but not glimepiride, significantly increased L/S ratio, and the effects of dapagliflozin and pioglitazone on L/S ratio were comparable.
","[{'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Shimoda', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakashima', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Fushimi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yurie', 'Initials': 'Y', 'LastName': 'Hirata', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tanabe', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Tatsumi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Hirukawa', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Sanada', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kohara', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Momoyo', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Obata', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Tomoatsu', 'Initials': 'T', 'LastName': 'Mune', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13279']
227,32326004,Low-Osmolality Carbohydrate-Electrolyte Solution Ingestion Avoid Fluid Loss and Oxidative Stress After Exhaustive Endurance Exercise.,"Low-osmolality carbohydrate-electrolyte solution (LCS) ingestion can replace losses from exercise-induced dehydration, but the benefits of LCS ingestion strategy after exhaustive endurance exercise (EEE) remain unknown. The present study evaluated the effects of LCS ingestion on dehydration, oxidative stress, renal function, and aerobic capacity after EEE. In our study with its double-blind, crossover, counterbalanced design, 12 healthy male participants were asked to consume LCS (150 mL four times per hour) or placebo (water) 1 h before and 1 h after EEE. All participants completed a graded exercise test to exhaustion on a treadmill for the determination of maximal oxygen consumption (VO 2max ), applied to further intensity calibration, and then completed the EEE test. The average heart rate, maximal heart rate, running time to exhaustion, and peak oxygen uptake (VO 2peak ) were recorded during the exercise period. The participants' body weight was recorded at different time points before and after the EEE to calculate the dehydration rate. Blood samples were drawn at baseline and before, immediately after, 1 h after, and 2 h after EEE to determine indicators of oxidative stress and renal function. The results indicated that the dehydration rates in participants with LCS ingestion at 15 min, 30 min, and 45 min after EEE were significantly lower than in participants with placebo ingestion (-1.86 ± 0.47% vs. -2.24 ± 0.72%; -1.78 ± 0.50% vs. -2.13 ± 0.74%; -1.54 ± 0.51% vs. -1.94 ± 0.72%, respectively;  p  < 0.05). In addition, the concentration of catalase in participants with LCS ingestion immediately after EEE was significantly higher than in participants with placebo ingestion (2046.21 ± 381.98 nmol/min/mL vs. 1820.37 ± 417.35 nmol/min/mL;  p  < 0.05). Moreover, the concentration of protein carbonyl in participants with LCS ingestion immediately after EEE was slightly lower than in participants with placebo ingestion (2.72 ± 0.31 nmol carbonyl/mg protein vs. 2.89 ± 0.43 nmol carbonyl/mg protein;  p  = 0.06). No differences were noted for other variables. Our findings conclude that LCS ingestion can effectively avoid fluid loss and oxidative stress after EEE. However, LCS ingestion had no benefits for renal function or aerobic capacity.",2020,"The average heart rate, maximal heart rate, running time to exhaustion, and peak oxygen uptake (VO 2peak ) were recorded during the exercise period.",['12 healthy male participants'],"['LCS ingestion', 'consume LCS', 'placebo', 'graded exercise test to exhaustion on a treadmill for the determination of maximal oxygen consumption (VO 2max ', 'Low-osmolality carbohydrate-electrolyte solution (LCS) ingestion']","['oxidative stress and renal function', 'renal function or aerobic capacity', 'average heart rate, maximal heart rate, running time to exhaustion, and peak oxygen uptake (VO 2peak ', 'concentration of catalase', 'dehydration rates', 'Oxidative Stress', 'dehydration, oxidative stress, renal function, and aerobic capacity', 'body weight', 'concentration of protein carbonyl']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",12.0,0.108625,"The average heart rate, maximal heart rate, running time to exhaustion, and peak oxygen uptake (VO 2peak ) were recorded during the exercise period.","[{'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei 11219, Taiwan.'}, {'ForeName': 'Yu-Tang', 'Initials': 'YT', 'LastName': 'Tung', 'Affiliation': 'Graduate Institute of Metabolism and Obesity Sciences, Taipei Medical University, Taipei 11301, Taiwan.'}, {'ForeName': 'Mai-Szu', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'TMU Research Center of Urology and Kidney, Taipei Medicine University, Taipei 110301, Taiwan.'}, {'ForeName': 'Ming-Che', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Taipei Medical University Hospital, Taipei 110301, Taiwan.'}, {'ForeName': 'Tsai-Jung', 'Initials': 'TJ', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, College of Medicine, Taipei Medical University, Taipei 110301, Taiwan.'}, {'ForeName': 'Ming-Ta', 'Initials': 'MT', 'LastName': 'Yang', 'Affiliation': 'Center for General Education, Taipei Medical University, Taipei 110301, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9040336']
228,30858518,Lithium continuation therapy following ketamine in patients with treatment resistant unipolar depression: a randomized controlled trial.,"The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t 32  = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.",2019,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"['Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5\u2009mg/kg', 'subjects with TRD', 'patients with treatment resistant unipolar depression (TRD', 'patients with treatment resistant unipolar depression', 'Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization']","['ketamine', 'matching placebo', 'ketamine and lithium', 'placebo', 'lithium or placebo', 'daily oral lithium', 'N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'Lithium continuation therapy', 'lithium and placebo', 'lithium or matching placebo']","['depression severity', 'depression severity as measured by the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",34.0,0.668127,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Laili', 'Initials': 'L', 'LastName': 'Soleimani', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spivack', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Levitch', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hoch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. james.murrough@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0365-0']
229,32327366,The Effect of Dry Needling on Lower Limb Dysfunction in Poststroke Survivors.,"BACKGROUND


Spasticity is one of the main complications in poststroke survivors leading to difficulties in walking and standing resulting in high levels of disability.
OBJECTIVE


The aim of the study was to investigate the effects of deep dry needling on lower limb dysfunction in poststroke spastic patients.
METHODS


A randomized clinical trial conducted in poststroke survivors who were assigned to one of 2 groups: Deep dry needling (intervention group) and sham dry needling (control group). The primary outcome measures were Modified Modified Ashworth Scale (MMAS) and functional tests (timed up and go test, 10-meter walk test). Secondary outcome measures were active ankle dorsiflexion range of motion (AROM), passive ankle dorsiflexion range of motion (PROM), single leg stance test, and Barthel index. All measurements were assessed at baseline (T0), immediately after the third session 1 week later (T1), and 1 month after the end of the intervention (T2).
RESULTS


We recruited 24 patients (71% male; mean age 57 ± 10 years; 26.4 ± 1.8 kg•m -2 ; time since event: 25.2 ± 12.5 months). There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points. There were no significant improvements in AROM assessments (P > .05).
CONCLUSIONS


Deep dry needling decreases muscle spasticity and improves lower limb function and gait speed in poststroke survivors.",2020,"There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points.","['24 patients (71% male; mean age 57 ± 10 years; 26.4 ± 1.8 kg•m -2 ; time since event: 25.2 ± 12.5 months', 'poststroke survivors who were assigned to one of 2 groups', 'Poststroke Survivors', 'poststroke spastic patients', 'poststroke survivors']","['Deep dry needling (intervention group) and sham dry needling (control group', 'Dry Needling', 'deep dry needling']","['active ankle dorsiflexion range of motion (AROM), passive ankle dorsiflexion range of motion (PROM), single leg stance test, and Barthel index', 'Lower Limb Dysfunction', 'Modified Modified Ashworth Scale (MMAS) and functional tests (timed up and go test, 10-meter walk test', 'MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM', 'lower limb function and gait speed', 'AROM assessments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444228', 'cui_str': 'Range of motion assessment'}]",71.0,0.0986201,"There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points.","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Ghannadi', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardalan', 'Initials': 'A', 'LastName': 'Shariat', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ardalansh2002@gmail.com.'}, {'ForeName': 'Noureddin Nakhostin', 'Initials': 'NN', 'LastName': 'Ansari', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Tavakol', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Honarpishe', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dommerholt', 'Affiliation': 'Bethesda Physiocare, Bethesda, Maryland; Myopain Seminars, Bethesda, Maryland.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Noormohammadpour', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Sport, Health & Exercise Science, University of Hull, Kingston-upon-Hull, United Kingdom.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104814']
230,32275230,Further study on the physiological effects of an alternative spit mask.,"OBJECTIVES


Spit masks are used by law enforcement officers and healthcare providers to protect themselves from the spread of communicable disease by subjects who pose a potential risk of biological exposure by spitting. Little research is available regarding the safety of these masks. However, concerns surround the ability of subjects to properly ventilate while wearing these masks as there are several anecdotal incidents of asphyxiation. A recent pilot study performed by our group showed no significant changes in ventilatory or circulatory parameters in healthy adults wearing a standard spit mask. In this study we aim to further this baseline research by testing physiological parameters in subjects wearing an alternative design of spit mask.
METHODS


This prospective study evaluated the changes in respiratory and circulatory parameters in healthy adult subjects wearing a Safariland Tranzport Hood spit mask (SKU: 8320-0-2C) at rest. Baseline measurements of pulse, blood pressure, respiratory rate, oxygen saturation, and end-tidal CO2 were taken while sitting at rest. The spit mask was then placed over the subject's head and repeat measurements were taken at 5, 10, and 15 min. Measurements at 5, 10, and 15 min were compared to baseline using paired t tests with 95% confidence intervals using SPSS.
RESULTS


A total of 15 subjects participated in the study. There was no significant difference between baseline and at 5, 10, and 15 min after spit mask application in heart rate (p = 0.246, p = 0.785, p = 0.502, respectively), oxygen saturation (p = 0.751, p = 0.334, p = 1.00, respectively), respiratory rate (p = 0.866, p = 0.270, p = 0.106, respectively), systolic blood pressure (p = 0.385, p = 0.481, p = 0.182, respectively), and diastolic blood pressure (p = 0.832, p = 0.516, p = 0.597, respectively). For end-tidal CO2, there was no significant difference between baseline and at 10 and 15 min (p = 0.586, p = 0.416, respectively). End-tidal CO2 was significantly increased from baseline at 5 min (p = 0.042).
CONCLUSIONS


In healthy adult subjects, there were no clinically significant differences in respiratory or circulatory parameters while wearing the Safariland Tranzport Hood spit mask.",2020,"There was no significant difference between baseline and at 5, 10, and 15 min after spit mask application in heart rate (p = ","['subjects wearing an alternative design of spit mask', 'healthy adult subjects wearing a Safariland Tranzport Hood spit mask (SKU: 8320-0-2C) at rest', 'healthy adult subjects', 'healthy adults wearing a standard spit mask', '15 subjects participated in the study']",['alternative spit mask'],"['respiratory or circulatory parameters', 'oxygen saturation', 'Baseline measurements of pulse, blood pressure, respiratory rate, oxygen saturation, and end-tidal CO2', 'systolic blood pressure', 'ventilatory or circulatory parameters', 'diastolic blood pressure', 'End-tidal CO2', 'respiratory rate', 'heart rate']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0232515', 'cui_str': 'Spitting'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0232515', 'cui_str': 'Spitting'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",15.0,0.0264753,"There was no significant difference between baseline and at 5, 10, and 15 min after spit mask application in heart rate (p = ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Marigold', 'Affiliation': 'University of California, San Diego School of Medicine, USA. Electronic address: omarigold@ucsd.edu.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Castillo', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego Medical Center, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sloane', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego Medical Center, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Brennan', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego Medical Center, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Coyne', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego Medical Center, USA.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Swift', 'Affiliation': 'University of California, San Diego School of Medicine, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego Medical Center, USA.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101945']
231,32179059,Oxytocin increases the social salience of the outgroup in potential threat contexts.,"A growing body of literature suggests that OT administration may affect not only prosocial outcomes, but also regulate adversarial responses in the context of intergroup relations. However, recent reports have challenged the view of a fixed role of OT in enhancing ingroup favoritism and outgroup derogation. Studying the potential effects of OT in modulating threat perception in a context characterized by racial miscegenation (Brazil) may thus afford additional clarification on the matter. In a double-blind, placebo-controlled study, White Brazilian participants completed a first-person shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members. OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets). In summary, our results indicate that a single dose of OT may promote accurate behavioral responses to potential threat from members of a racial outgroup, thus offering support to the social salience hypothesis.",2020,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).",['White Brazilian participants completed a firstperson shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members'],"['OT', 'Oxytocin', 'placebo']",['social salience'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.040038,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Egito', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nevat', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Ana Alexandra C', 'Initials': 'AAC', 'LastName': 'Osório', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil. Electronic address: ana.osorio@mackenzie.br.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104733']
232,32330694,Loading modality and age influence teriparatide-induced bone formation in the human femoral neck.,"Teriparatide (TPTD) reduces risk of both vertebral and nonvertebral fracture, but increases bone mineral density (BMD) much more at the spine than the hip. TPTD and mechanical loading may have a synergistic anabolic effect on BMD, which may help explain these site-specific differences. Under normal daily activity, the femoral neck (FN) is under bending, placing one side under tension and the other under compression. We sought to further understand the relationship between mechanical loading and TPTD at the hip by investigating the effect of tensile versus compressive loading on TPTD stimulated bone formation indices in the human FN. Thirty-eight patients receiving total hip replacements for osteoarthritis were randomized to receive placebo (PBO) or TPTD for a mean treatment duration of 6 weeks prior to surgery, and double tetracycline labeling was administered to allow assessment of bone formation. The FN was harvested during surgery and analyzed for dynamic bone formation indices in the compressive and tensile regions of the endocortical and periosteal envelopes. Regression models relating outcome measures to patient characteristics including sex, age, body weight, and FN geometry were also analyzed. Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface. The level of bone formation in both TPTD and placebo groups was greater on the tensile endocortical surface and the compressive periosteal surface. There was a trend toward decreased endocortical eroded surface with TPTD in the compressive but not the tensile region. Patient age and sex explained the greatest variability in endocortical bone formation, and patient body mass and sex explained the greatest variability in periosteal bone formation. Our data represent the first dynamic comparison of teriparatide treatment under two loading modalities in human FN samples. Future work could determine whether specific hip loading intervention could amplify the benefits of teriparatide on the hip in clinical settings.",2020,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","['Thirty-eight patients receiving total hip replacements for osteoarthritis', 'human femoral neck', 'human FN']","['teriparatide', 'TPTD versus placebo', 'placebo', 'tetracycline labeling', 'teriparatide-induced bone formation', 'Teriparatide (TPTD', 'placebo (PBO) or TPTD']","['level of bone formation', 'bone mineral density (BMD', 'tensile endocortical surface', 'bone formation', 'patient characteristics including sex, age, body weight, and FN geometry']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}]",38.0,0.027878,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Rooney', 'Affiliation': 'Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, 101 Weill Hall, Ithaca, NY 14853, USA. Electronic address: amr427@cornell.edu.'}, {'ForeName': 'Mathias P G', 'Initials': 'MPG', 'LastName': 'Bostrom', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA. Electronic address: BostromM@hss.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Pathology, Columbia University, 630 West 168th St., New York, NY 10025, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA; Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Epidemiology, Columbia University, 722 West 168th St., New York, NY 10032, USA. Electronic address: jwn5@cumc.columbia.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA. Electronic address: zhouh@helenhayeshosp.org.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, 622 West 168th St., New York, NY 10032, USA. Electronic address: fc14@cumc.columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115373']
233,32194251,Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial.,"BACKGROUND


North America is facing an unprecedented public health crisis of opioid-related morbidity and mortality, increasingly as a result of the introduction of illicitly manufactured fentanyl into the street drug market. Although the treatment of opioid use disorder (OUD) is a key element in the response to the opioid overdose epidemic, currently available pharmacotherapies (e.g., methadone, buprenorphine) may not be acceptable to or effective in all patients. Available evidence suggests that slow-release oral morphine (SROM) has similar efficacy rates as methadone with respect to promoting abstinence, and with improvements in a number of patient-reported outcomes among persons using heroin. However, little is known about the relative effectiveness and acceptability of SROM compared to methadone in the context of fentanyl use. This study aims to address this research gap.
METHODS


pRESTO is a 24-week, open-label, two arm, non-inferiority, randomized controlled trial comparing SROM versus methadone for the treatment of OUD. Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl. The primary outcome is suppression of illicit opioid use, measured by bi-weekly urine drug screens. Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
DISCUSSION


pRESTO will be among the first studies to evaluate treatment options for individuals primarily using synthetic street opioids, providing important evidence to guide treatment strategies for this population.",2020,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","['Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl']","['methadone, buprenorphine', 'methadone', 'morphine', 'morphine (SROM']","['suppression of illicit opioid use, measured by bi-weekly urine drug screens', 'efficacy rates', ' treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",298.0,0.110341,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","[{'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: bccsu-es@bccsu.ubc.ca.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Brar', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Fairbairn', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105993']
234,30723321,"Efficacy of the pharmacologic chaperone migalastat in a subset of male patients with the classic phenotype of Fabry disease and migalastat-amenable variants: data from the phase 3 randomized, multicenter, double-blind clinical trial and extension study.","PURPOSE


Outcomes in patients with Fabry disease receiving migalastat during the phase 3 FACETS trial (NCT00925301) were evaluated by phenotype.
METHODS


Data were evaluated in two subgroups of patients with migalastat-amenable GLA variants: ""classic phenotype"" (n = 14; males with residual peripheral blood mononuclear cell α-galactosidase A <3% normal and multiorgan system involvement) and ""other patients"" (n = 36; males not meeting classic phenotype criteria and all females). Endpoints included estimated glomerular filtration rate (eGFR), left ventricular mass index (LVMi), Gastrointestinal Symptoms Rating Scale diarrhea subscale (GSRS-D), renal peritubular capillary (PTC) globotriaosylceramide (GL-3) inclusions, and plasma globotriaosylsphingosine (lyso-Gb 3 ).
RESULTS


Baseline measures in the classic phenotype patients suggested a more severe phenotype. At month 24, mean (SD) annualized change in eGFR CKD-EPI  with migalastat was -0.3 (3.76) mL/min/1.73 m 2  in the classic phenotype subgroup; changes in LVMi, GSRS-D, and lyso-Gb 3  were -16.7 (18.64) g/m 2 , -0.9 (1.66), and -36.8 (35.78) nmol/L, respectively. At month 6, mean PTC GL-3 inclusions decreased with migalastat (-0.8) and increased with placebo (0.3); switching from placebo to migalastat, PTC inclusions decreased by -0.7. Numerically smaller changes in these endpoints were observed in the other patients.
CONCLUSION


Migalastat provided clinical benefit to patients with Fabry disease and amenable variants, regardless of disease severity.",2019,"Endpoints included estimated glomerular filtration rate (eGFR), left ventricular mass index (LVMi), Gastrointestinal Symptoms Rating Scale diarrhea subscale (GSRS-D), renal peritubular capillary (PTC) globotriaosylceramide (GL-3) inclusions, and plasma globotriaosylsphingosine (lyso-Gb 3 ).
","['male patients with the classic phenotype of Fabry disease and migalastat-amenable variants', 'patients with Fabry disease receiving migalastat during the phase 3 FACETS trial (NCT00925301) were evaluated by phenotype', 'm 2  in the classic phenotype subgroup', 'Data were evaluated in two subgroups of patients with migalastat-amenable GLA variants: ""classic phenotype"" (n\u2009=\u200914; males with residual peripheral blood mononuclear cell α-galactosidase']","['pharmacologic chaperone migalastat', 'placebo']","['changes in LVMi, GSRS-D, and lyso-Gb 3', 'glomerular filtration rate (eGFR), left ventricular mass index (LVMi), Gastrointestinal Symptoms Rating Scale diarrhea subscale (GSRS-D), renal peritubular capillary (PTC) globotriaosylceramide (GL-3) inclusions, and plasma globotriaosylsphingosine (lyso-Gb 3 ', 'mean (SD) annualized change in eGFR CKD-EPI  with migalastat', 'severe phenotype', 'mean PTC GL-3 inclusions']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0002986', 'cui_str': 'alpha-Galactosidase A Deficiency'}, {'cui': 'C2698220', 'cui_str': 'migalastat'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0016955', 'cui_str': 'Galactosidase'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C2698220', 'cui_str': 'migalastat'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456918', 'cui_str': 'Peritubular (qualifier value)'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0061338', 'cui_str': 'P(K) antigen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C2698220', 'cui_str': 'migalastat'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}]",36.0,0.088972,"Endpoints included estimated glomerular filtration rate (eGFR), left ventricular mass index (LVMi), Gastrointestinal Symptoms Rating Scale diarrhea subscale (GSRS-D), renal peritubular capillary (PTC) globotriaosylceramide (GL-3) inclusions, and plasma globotriaosylsphingosine (lyso-Gb 3 ).
","[{'ForeName': 'Dominique P', 'Initials': 'DP', 'LastName': 'Germain', 'Affiliation': 'Division of Medical Genetics and Inserm U1179, University of Versailles, Paris-Saclay University, Montigny, France. dominique.germain@inserm.fr.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Nicholls', 'Affiliation': 'Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giugliani', 'Affiliation': 'Medical Genetics Service, HCPA, and Department of Genetics, UFRGS, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Bichet', 'Affiliation': 'Department of Nephrology, Hôpital du Sacré-Coeur, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Derralynn A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Royal Free NHS Foundation Trust and University College London, London, UK.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Barisoni', 'Affiliation': 'Department of Pathology, University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Colvin', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'J Charles', 'Initials': 'JC', 'LastName': 'Jennette', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Skuban', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Castelli', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Elfrida', 'Initials': 'E', 'LastName': 'Benjamin', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Barth', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Viereck', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0451-z']
235,32329309,Baclofen-induced Changes in the Resting Brain Modulate Smoking Cue Reactivity: A Double-blind Placebo-controlled Functional Magnetic Resonance Imaging Study in Cigarette Smokers.,"Objective


Smoking cue-(SC) elicited craving can lead to relapse in SC-vulnerable individuals. Thus, identifying treatments that target SC-elicited craving is a top research priority. Reduced drug cue neural activity is associated with recovery and is marked by a profile of greater tonic (resting) activation in executive control regions, and increased connectivity between executive and salience regions. Evidence suggests the GABA-B agonist baclofen can reduce drug cue-elicited neural activity, potentially through its actions on the resting brain. Based on the literature, we hypothesize that baclofen's effects in the resting brain can predict its effects during SC exposure.
Methods


In this longitudinal, double blind, placebo-controlled neuropharmacological study 43 non-abstinent, sated treatment-seeking cigarette smokers (63% male) participated in an fMRI resting-state scan and a SC-reactivity task prior to (T1) and 3 weeks following randomization (T2; baclofen: 80 mg/day; n = 21). Subjective craving reports were acquired before and after SC exposure to explicitly examine SC-induced craving.
Results


Whole-brain full-factorial analysis revealed a group-by-time interaction with greater resting brain activation of the right dorsolateral prefrontal cortex (dlPFC) at T2 in the baclofen group (BAC) ( p FWEcorr  = 0.02), which was associated with reduced neural responses to SCs in key cue-reactive brain regions; the anterior ventral insula and ventromedial prefrontal cortex ( p FWEcorr  ＜ 0.01). BAC, but not the placebo group reported decreased SC-elicited craving ( p  = 0.02).
Conclusion


Results suggest that baclofen mitigates the reward response to SCs through an increase in tonic activation of the dlPFC, an executive control region. Through these mechanisms, baclofen may offer SC-vulnerable smokers protection from SC-induced relapse.",2020,"BAC, but not the placebo group reported decreased SC-elicited craving ( p  = 0.02).
","['study 43 non-abstinent, sated treatment-seeking cigarette smokers (63% male) participated in an', 'Cigarette Smokers', 'SC-vulnerable individuals']","['fMRI resting-state scan and a SC-reactivity task prior to (T1', 'Placebo', 'placebo', 'placebo-controlled neuropharmacological']","['SC-elicited craving', 'Resting Brain Modulate Smoking Cue Reactivity', 'resting brain activation of the right dorsolateral prefrontal cortex (dlPFC', 'tonic activation', 'Subjective craving reports']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.126419,"BAC, but not the placebo group reported decreased SC-elicited craving ( p  = 0.02).
","[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Ketcherside', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kanchana', 'Initials': 'K', 'LastName': 'Jagannathan', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Dolui', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hager', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Spilka', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Chaela', 'Initials': 'C', 'LastName': 'Nutor', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Franklin', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Wetherill', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.2.289']
236,31728664,"A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","PURPOSE


A typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.
METHODS


A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.
SETTING


A phase III study in healthy women aged 18-45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles.
POPULATION


A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.
MAIN OUTCOME MEASURES


The primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2-4 and cycles 7-9.
RESULTS


In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
CONCLUSIONS


This report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method. EudraCT Registration Number: 2011-002396-42.",2019,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","['healthy women aged 18-45\xa0years', '858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed']","['DRSP-only pill', 'DRSP', 'desogestrel 0.075\xa0mg', 'DRSP tablets', 'traditional progestin-only pills', 'Desogestrel', 'placebo versus desogestrel', 'drospirenone']","['bleeding profile and safety', 'bleeding profile', 'proportion of women with unscheduled bleeding/spotting', 'proportion of women with unscheduled bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",858.0,0.145873,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña, 9, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05340-4']
237,32298704,Pain-modulating effects of oxytocin in patients with chronic low back pain.,"The neuropeptide oxytocin (OT) has been shown to play a modulatory role in nociception. However, analgesic effects of OT in chronic pain conditions remain elusive and the neural underpinnings have not yet been investigated in humans. Here, we conducted an exploratory, randomized, placebo-controlled, cross-over study to examine effects of intranasal OT in male patients suffering from chronic low back pain (CBP) versus healthy controls (HC). N = 22 participants with CBP and 22 HCs were scanned using functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back. During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs. Spontaneously experienced pain in contrast to heat pain was associated with activation changes in the medial frontal cortex (MFC) and the anterior cingulate cortex (ACC) as reported in previous studies. However, we did not observe OT effects on spontaneously experienced pain in CBP patients. Overall, our preliminary data may suggest that the striatum is a key structure underlying the pain-modulating effects of OT in patients with chronic pain and adds to the growing evidence linking the neuropeptide to pain modulation in humans. Further studies on neuronal OT effects in larger samples of chronic back pain patients are needed to understand probable mechanisms of OT effects in chronic pain. This article is part of the special issue on Neuropeptides.",2020,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"['N\u202f=\u202f22 participants with CBP and 22\u202fHCs', 'male patients suffering from chronic low back pain (CBP) versus healthy controls (HC', 'patients with chronic low back pain', 'chronic back pain patients', 'patients with chronic pain']","['neuropeptide oxytocin (OT', 'OT', 'OT versus PL', 'intranasal OT', 'placebo', 'functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back', 'oxytocin']","['BOLD responses', 'pain intensity ratings', 'medial frontal cortex (MFC) and the anterior cingulate cortex (ACC', 'OT effects']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004600', 'cui_str': 'Back'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",22.0,0.105867,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ueltzhoeffer', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany; Department of Psychology and Psychotherapy, Ludwigs-Maximilian-University München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Nees', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Department of Neuropeptide Research in Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany. Electronic address: Sabine.Herpertz@med.uni-heidelberg.de.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108105']
238,32325176,Effect of preparation design on the fracture behavior of ceramic occlusal veneers in maxillary premolars.,"OBJECTIVES


The fracture strengths of four types of occlusal veneers and a traditional full crown ceramic restoration and the influence of preparation design on the stress of restorations were examined.
METHODS


Forty intact maxillary premolars randomly divided into five groups were prepared based on the demands of type O (occlusal surface coverage), OF (occlusal and lingual surface coverage), POF (occlusal, lingual, and mesial surface coverage), and POFP (occlusal, lingual, mesial, and distal surface coverage) veneers and full crown, and then restored by glass ceramic. Specimens were subjected to fracture resistance tests after cyclic loading. The fracture strengths and modes were analyzed statistically. The level of significance was set at α = 0.05. One maxillary premolar was prepared for type O, OF, POF, POFP veneer and full crown, and then scanned to establish finite element models. The mean fracture load was applied vertically to calculate the maximum principal stress on the ceramic.
RESULTS


Type O veneer showed higher fracture strength than type POF and POFP veneers (P < 0.05). Both type O and OF veneers exhibited higher fracture strength than full crown (P < 0.05). No significant difference in failure mode was observed. The maximum principal stress for type O, OF, POF, POFP veneers, and full crown increased progressively and concentrated at the bonding surface directly beneath the loading area.
CONCLUSIONS


Four types of occlusal veneer showed fracture strengths that considerably exceeded normal biting forces. They represent conservative alternatives to full crowns and present a viable treatment for severely worn teeth.
CLINICAL SIGNIFICANCE


The occlusal veneers with different preparation designs, including type O, OF, POF and POFP veneers, show higher fracture resistances than traditional full coverage crowns that considerably exceed the normal biting forces. Therefore, these represent conservative alternatives to crown restorations and present a viable treatment for restoring severely worn teeth.",2020,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"['Forty intact maxillary premolars', 'maxillary premolars']",[],"['fracture behavior of ceramic occlusal veneers', 'failure mode', 'maximum principal stress for type O, OF, POF, POFP veneers, and full crown', 'fracture strengths', 'fracture strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]",[],"[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",40.0,0.0209738,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"[{'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: huangxq36@mail2.sysu.edu.cn.""}, {'ForeName': 'Leiyan', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: zouly5@mail2.sysu.edu.cn.""}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: shuyiwu@21cn.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: liy8@mail.sysu.edu.cn.""}]",Journal of dentistry,['10.1016/j.jdent.2020.103346']
239,31770656,Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF.,"Many therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF study is a prospective, cluster-randomized trial of 161 hospitals in the United States with a 2×2 factorial design. The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective). The hospital and post-discharge intervention includes audit and feedback on HF clinical process measures and outcomes for patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts. The patient-level digital intervention is an optional ancillary study and includes a mobile application and behavioral tools that are intended to facilitate improved use of guideline-directed recommendations for self-monitoring and self-management of activity and medications for HFrEF. The effects of the interventions will be measured through an opportunity-based composite score on quality and time-to-first HF readmission or death among patients with HFrEF who present to study hospitals with acute HF and who consent to participate. The CONNECT-HF study is evaluating approaches for implementing HF guideline recommendations into practice and is one of the largest HF implementation science trials performed to date.",2020,"The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective).","['patients with heart failure (HF', '161 hospitals in the United States with a 2×2 factorial design', 'patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts', 'patients with HFrEF who present to study hospitals with acute HF and who consent to participate']",['hospital and post-discharge quality improvement intervention'],"['HF outcomes and quality-of-care', 'quality and time-to-first HF readmission or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",161.0,0.0683991,"The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective).","[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC. Electronic address: adam.devore@duke.edu.'}, {'ForeName': 'Bradi B', 'Initials': 'BB', 'LastName': 'Granger', 'Affiliation': 'Duke University School of Nursing, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Albert', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University and Detroit Medical Center, Detroit, MI.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Heidenreich', 'Affiliation': 'Division of Cardiology, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Cyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Cooper', 'Affiliation': 'Department of Heart Failure and Transplantation, Inova Heart and Vascular Institute, Falls Church, VA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'A Thomas', 'Initials': 'AT', 'LastName': 'McRae', 'Affiliation': 'Centennial Heart, Nasheville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Department of Medicine, Cardiovascular Division, and Henry Ford Heart and Vascular Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Harrison', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Robb D', 'Initials': 'RD', 'LastName': 'Kociol', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Maghee', 'Initials': 'M', 'LastName': 'Disch', 'Affiliation': 'American College of Cardiology.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Center for Advanced Hindsight, Duke University, Durham, NC.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Center for Advanced Hindsight, Duke University, Durham, NC.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2019.09.012']
240,32187404,Modulation of experimental facial pain via somatosensory stimuli targeting sensations of different valence.,"BACKGROUND


Knowledge of pain modulation from oro-facial somatosensory stimuli with different valence (pleasant-unpleasant) is limited.
OBJECTIVES


To investigate (a) the modulatory effects of painful, pleasant and unpleasant somatosensory stimuli on two models of experimental facial pain, (b) whether modulation could be changed by blocking peripheral nerves via application of a local anaesthetic, EMLA, or blocking endogenous opioid receptors via naltrexone and (c) whether pain ratings were significantly correlated with participant psychological profiles.
METHODS


Thirty-eight healthy women received experimental facial skin burning pain or jaw myalgia for four randomised sessions on different days. The painful region was stimulated with mechanical or thermal painful, pleasant, unpleasant and control stimuli, with ratings recorded before and during stimulation. Sessions differed in pre-treatment: EMLA/naltrexone/placebo tablet/cream.
RESULTS


Significant effects of thermal or mechanical stimuli (P < .017), but not session (P > .102), were found on pain ratings for both models. In myalgia, painful cold resulted in a greater reduction in pain ratings than unpleasant cold, pleasant cold, control and pleasant warmth (P < .004). Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli were greater than control (P < .002). In burning pain, painful cold resulted in a greater reduction in pain ratings than all but one of the other thermal stimuli (P < .033). The pleasant mechanical stimulus reduced pain ratings more than all other mechanical stimuli (P ≤ .003). There were no significant correlations between pain and psychometrics.
CONCLUSION


Valence-targeted thermal and mechanical stimuli modulated experimental myalgia and skin burning pain (P < .017). Partially blocking peripheral afferents or opioid receptors did not affect modulation.",2020,"Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli was greater than control (P<0.002).",['38 healthy women received'],"['experimental facial skin burning pain or jaw myalgia', 'painful, pleasant and unpleasant somatosensory stimuli', 'EMLA/naltrexone/placebo tablet/cream']","['myalgia and skin burning pain', 'pain ratings from painful, unpleasant and pleasant mechanical stimuli', 'pain and psychometrics', 'pain ratings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0234230', 'cui_str': 'Pain, Burning'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0234230', 'cui_str': 'Pain, Burning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}]",38.0,0.0493908,"Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli was greater than control (P<0.002).","[{'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Taneja', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Olausson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Trulsson', 'Affiliation': 'Scandinavian Centre for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baad-Hansen', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Journal of oral rehabilitation,['10.1111/joor.12963']
241,31028124,Framing advance care planning in Parkinson disease: Patient and care partner perspectives.,"OBJECTIVE


Advance care planning (ACP) is a core quality measure in caring for individuals with Parkinson disease (PD) and there are no best practice standards for how to incorporate ACP into PD care. This study describes patient and care partner perspectives on ACP to inform a patient- and care partner-centered framework for clinical care.
METHODS


This is a qualitative descriptive study of 30 patients with PD and 30 care partners within a multisite, randomized clinical trial of neuropalliative care compared to standard care. Participants were individually interviewed about perspectives on ACP, including prior and current experiences, barriers to ACP, and suggestions for integration into care. Interviews were analyzed using theme analysis to identify key themes.
RESULTS


Four themes illustrate how patients and care partners perceive ACP as part of clinical care: (1) personal definitions of ACP vary in the context of PD; (2) patient, relationship, and health care system barriers exist to engaging in ACP; (3) care partners play an active role in ACP; (4) a palliative care approach positively influences ACP. Taken together, the themes support clinician initiation of ACP discussions and interdisciplinary approaches to help patients and care partners overcome barriers to ACP.
CONCLUSIONS


ACP in PD may be influenced by patient and care partner perceptions and misperceptions, symptoms of PD (e.g., apathy, cognitive dysfunction, disease severity), and models of clinical care. Optimal engagement of patients with PD and care partners in ACP should proactively address misperceptions of ACP and utilize clinic teams and workflow routines to incorporate ACP into regular care.",2019,"RESULTS


Four themes illustrate how patients and care partners perceive ACP as part of clinical care: (1) personal definitions of ACP vary in the context of PD; (2) patient, relationship, and health care system barriers exist to engaging in ACP; (3) care partners play an active role in ACP; (4) a palliative care approach positively influences ACP.","['individuals with Parkinson disease (PD', 'Parkinson disease', 'patients with PD and care partners in ACP', '30 patients with PD and 30 care partners within a multisite']","['neuropalliative care compared to standard care', 'Advance care planning (ACP']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]",[],,0.017024,"RESULTS


Four themes illustrate how patients and care partners perceive ACP as part of clinical care: (1) personal definitions of ACP vary in the context of PD; (2) patient, relationship, and health care system barriers exist to engaging in ACP; (3) care partners play an active role in ACP; (4) a palliative care approach positively influences ACP.","[{'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada. Hillary.lum@ucdenver.edu.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jordan', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adreanne', 'Initials': 'A', 'LastName': 'Brungardt', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ayele', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Benzi', 'Initials': 'B', 'LastName': 'Kluger', 'Affiliation': 'From the Division of Geriatric Medicine, Department of Medicine (H.D.L., S.R.J., A.B.), College of Nursing (R.A., J.J.), and Department of Neurology (B.K.), University of Colorado Anschutz Medical Campus, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center (H.D.L.); Denver-Seattle Center of Innovation (R.A.), Rocky Mountain Regional Veterans Affairs Medical Center, Denver, CO; Movement Disorders and Neuromodulation Center (M.K.) and Research Stakeholder (A.H.), University of California, San Francisco; and Division of Neurology (J.M.M.), University of Alberta, Edmonton, Canada.'}]",Neurology,['10.1212/WNL.0000000000007552']
242,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z']
243,31601541,"Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial.","BACKGROUND


Up to now, immunisation regimens that have been assessed for development of HIV vaccines have included purified envelope (Env) protein among the boosting components of the regimen. We postulated that co-administration of Env protein with either a DNA or NYVAC vector during priming would result in early generation of antibody responses to the Env V1/V2 region, which are important markers for effective protection against infection. We aimed to assess the safety and immunogenicity of a multivalent HIV vaccine including either DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost.
METHODS


We did a single-centre, double-blind, placebo-controlled phase 1b trial at the Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland). We included healthy volunteers aged 18-50 years who were at low risk of HIV infection. We randomly allocated participants using computer-generated random numbers to one of four vaccination schedules or placebo (4:1), and within these schedules participants were allocated either active treatment (T1, T2, T3, and T4) or placebo (C1, C2, C3, and C4). T1 consisted of two doses of NYVAC vector followed by two doses of NYVAC vector and gp120 Env protein; T2 comprised four doses of NYVAC vector and gp120 Env protein; T3 was two doses of DNA vector followed by two doses of NYVAC vector and gp120 Env protein; and T4 was two doses of DNA vector and gp120 Env protein followed by two doses of NYVAC vector and gp120 Env protein. Placebo injections were matched to the corresponding active treatment group. Doses were administered by injection at months 0, 1, 3, and 6. Primary outcomes were safety and immunogenicity of the vaccine schedules. Immune response measures included cross-clade and epitope-specific binding antibodies, neutralising antibodies, and antibody-dependent cell-mediated cytotoxicity measured 2 weeks after the month 1, 3, and 6 vaccinations. This trial is registered with ClinicalTrials.gov, NCT01799954.
FINDINGS


Between Aug 23, 2012, and April 18, 2013, 148 healthy adult volunteers were screened for the trial, of whom 96 participants were enrolled. 20 individuals were allocated to each active treatment group (groups T1-4; n=80) and four were assigned to each placebo group (groups C1-4; n=16). Vaccines containing the NYVAC vector (groups T1 and T2) were associated with more frequent severe reactogenicity and more adverse events than were vaccines containing the DNA vector (groups T3 and T4). The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2). Two participants, one in the placebo group and one in the DNA-primed T3 group, had serious adverse events that were judged unrelated to study product. One participant in the T3 group died from cranial trauma after a motor vehicle accident. Across the active treatment groups, IgG responses 2 weeks after the 6-month dose of vaccine were 74-95%. Early administration of gp120 Env protein (groups T2 and T4) was associated with a substantially earlier and higher area under the curve for gp120 Env binding, production of anti-V1/V2 and neutralising antibodies, and better antibody-response coverage over a period of 18 months, compared with vaccination regimens that delayed administration of gp120 Env protein until the 3-month vaccination (groups T1 and T3).
INTERPRETATION


Co-administration of gp120 Env protein components with DNA or NYVAC vectors during priming led to early and potent induction of Env V1/V2 IgG binding antibody responses. This immunisation approach should be considered for induction of preventive antibodies in future HIV vaccine efficacy trials.
FUNDING


National Institutes of Health, National Institute of Allergy and Infectious Diseases, and the Bill & Melinda Gates Foundation.",2019,The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2).,"['Between Aug 23, 2012, and April 18, 2013', '148 healthy adult volunteers were screened for the trial, of whom 96 participants were enrolled', '20 individuals', 'healthy volunteers aged 18-50 years who were at low risk of HIV infection']","['Placebo', 'DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost', 'placebo (C1, C2, C3, and C4', 'placebo', 'gp120 Env protein', 'multivalent HIV vaccine', 'DNA or NYVAC vector']","['safety and immunogenicity of the vaccine schedules', 'adverse events', 'safety and immunogenicity', 'Immune response measures included cross-clade and epitope-specific binding antibodies, neutralising antibodies, and antibody-dependent cell-mediated cytotoxicity', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0282397', 'cui_str': 'env Glycoproteins'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0017278', 'cui_str': 'env Protein'}, {'cui': 'C0019691', 'cui_str': 'Envelope Glycoprotein gp120, HIV'}, {'cui': 'C0086413'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0003316', 'cui_str': 'Antigenic Determinants'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0301896', 'cui_str': 'Cell-mediated lympholysis, function (observable entity)'}]",148.0,0.354877,The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2).,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland. Electronic address: giuseppe.pantaleo@chuv.ch.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Janes', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'G Laissa', 'Initials': 'GL', 'LastName': 'Ouedraogo', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Bill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Esteban', 'Affiliation': 'Department of Molecular and Cellular Biology, Centro Nacional de Biotecnología, Consejo Superior de Investigaciones Científicas, Madrid, Spain.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany; Institute of Clinical Microbiology and Hygiene, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bart', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Rettby', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30262-0']
244,32329438,Enhancing Patient Activation and Self-Management Activities in Patients With Type 2 Diabetes Using the US Department of Defense Mobile Health Care Environment: Feasibility Study.,"BACKGROUND


Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information.
OBJECTIVE


The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting.
METHODS


A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes.
RESULTS


The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA 1c ) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA 1c  (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA 1c  (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12).
CONCLUSIONS


Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.6993.",2020,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","['participants had mean age of 62.8 years, mean HbA1c of 7.5', 'Patients with Type 2 Diabetes using the U.S. Department of Defense Mobile Health Care Environment', '240 patients to either the']","['MHCE intervention (n=123, received enabling mHealth technology and behavioral messages tailored to Patient Activation Measure® (PAM®) level at baseline or the control group (n=117, received equipment but not behavioral messaging, ""intervention-lite']","['PAM® scores', 'PAM® score', 'BMI', 'Summary of Diabetes Self-care Activities (SDSCA) scores and cardiometabolic outcomes', 'HDL cholesterol levels', 'LDL cholesterol (control mean', 'PAM® score, SDSCA, and waist size for both groups, and diastolic and systolic blood pressure', 'SDSCA, BMI, waist size, and diastolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",240.0,0.02861,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","[{'ForeName': 'Ronald W', 'Initials': 'RW', 'LastName': 'Gimbel', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lior M', 'Initials': 'LM', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Jeanette R', 'Initials': 'JR', 'LastName': 'Little', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Khoa', 'Initials': 'K', 'LastName': 'Truong', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Griffin', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'LingLing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, United States.'}, {'ForeName': 'Jennie B', 'Initials': 'JB', 'LastName': 'Moss', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Marshall', 'Affiliation': 'Clinical Informatics Fellowship Program, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Edwards', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hing', 'Affiliation': 'Department of Internal Medicine, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schmeltz', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lumsden', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Ashby', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Haas', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Palazzo', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}]",Journal of medical Internet research,['10.2196/17968']
245,32325717,Serum Follicle-Stimulating Hormone Levels Are Associated with Cardiometabolic Risk Factors in Post-Menopausal Korean Women.,":  Menopause compounds many cardiometabolic risk factors through endogenous estrogen withdrawal. This study aimed to find the association between serum follicle-stimulating hormone (FSH) levels and cardiometabolic risk factors in post-menopausal Korean women. A total of 608 post-menopausal women from eight randomized double-blind, placebo-controlled clinical trials on menopause during the year 2012-2019 were analyzed. Cardiometabolic risk factors such as body mass index, waist circumference, systolic blood pressure, fasting glucose, triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), and TG/HDL-C ratio were significantly improved as the FSH quartiles increased. Metabolic syndrome (MetS) and the number of components of MetS decreased as FSH quartiles increased. In regression analysis, FSH level was negatively associated with cardiometabolic risk factors including body mass index, body weight, waist circumference, fasting glucose and TG, while it was positively associated with HDL-C. The odds ratio of MetS in the first quartile of FSH was 2.682 compared with that in the fourth quartile of FSH in a logistic regression model. Serum FSH levels had a negative correlation with cardiometabolic risk factors in post-menopausal Korean women, suggesting that a low FSH can be a predictor for cardiovascular disease in post-menopausal women.",2020,The odds ratio of MetS in the first quartile of FSH was 2.682 compared with that in the fourth quartile of FSH in a logistic regression model.,"['608 post-menopausal women', 'Post-Menopausal Korean Women', 'controlled clinical trials on menopause during the year 2012-2019 were analyzed', 'post-menopausal Korean women']",['placebo'],"['Cardiometabolic risk factors such as body mass index, waist circumference, systolic blood pressure, fasting glucose, triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), and TG/HDL-C ratio', 'Metabolic syndrome (MetS', 'cardiometabolic risk factors including body mass index, body weight, waist circumference, fasting glucose and TG', 'odds ratio of MetS', 'Serum FSH levels', 'Serum Follicle-Stimulating Hormone Levels', 'serum follicle-stimulating hormone (FSH) levels and cardiometabolic risk factors']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0455276', 'cui_str': 'Serum follicle stimulating hormone measurement'}]",,0.0812448,The odds ratio of MetS in the first quartile of FSH was 2.682 compared with that in the fourth quartile of FSH in a logistic regression model.,"[{'ForeName': 'Eun-Soo', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}, {'ForeName': 'Byung-Hyun', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Chonbuk National University Medical School, Jeonju, Jeonbuk 54896, Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9041161']
246,31944869,Exploring Input Parameters in an Expressive Vocabulary Treatment With Late Talkers.,"Purpose The aims of this study were (a) to assess the efficacy of the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment and (b) to compare treatment outcomes for expressive vocabulary acquisition in late talkers in 2 conditions: 3 target words/90 doses per word per session versus 6 target words/45 doses per word per session. Method We ran the treatment protocol for 16 sessions with 24 primarily monolingual English-speaking late talkers. We calculated a  d  score for each child, compared treatment to control effect sizes, and assessed the number of words per week children acquired outside treatment. We compared treatment effect sizes of children in the condition of 3 target words/90 doses per word to those in the condition of 6 target words/45 doses per word. We used Bayesian repeated-measures analysis of variance and Bayesian  t  tests to answer our condition-level questions. Results With an average treatment effect size of almost 1.0, VAULT was effective relative to the no-treatment condition. There were no differences between the different dose conditions. Discussion The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters. Supplemental Material https://doi.org/10.23641/asha.11593323.",2020,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","['16 sessions with 24 primarily monolingual English-speaking late talkers', 'late talkers in 2 conditions']",['Vocabulary Acquisition and Usage for Late Talkers (VAULT'],[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],,0.0318903,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Alt', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Mettler', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Jessie A', 'Initials': 'JA', 'LastName': 'Erikson', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Cecilia R', 'Initials': 'CR', 'LastName': 'Figueroa', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Etters-Thomas', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Genesis D', 'Initials': 'GD', 'LastName': 'Arizmendi', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Trianna', 'Initials': 'T', 'LastName': 'Oglivie', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00219']
247,32329160,Exenatide once weekly decreases urinary albumin excretion in patients with type 2 diabetes and elevated albuminuria: Pooled analysis of randomized active controlled clinical trials.,"AIMS


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


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


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


Exenatide once weekly reduced uACR in patients with type 2 diabetes and elevated albuminuria compared to commonly used glucose-lowering drugs.",2020,EQW reduced uACR in patients with T2D and elevated albuminuria compared to commonly used glucose-lowering drugs.,"['patients with type 2 diabetes and elevated albuminuria', 'patients with type 2 diabetes (T2D', 'patients with diabetes and chronic kidney disease', 'patients with T2D and baseline uACR ≥30']","['exenatide once weekly (EQW', 'active glucose-lowering comparators', 'glucagon-like peptide-1 receptor agonists (GLP-1 RA', 'EQW', 'Exenatide']","['urine albumin-to-creatinine ratio (uACR', 'HbA1c, SBP and BW', 'uACR lowering effect', 'glycated haemoglobin (HbA1c), systolic blood pressure (SBP), body weight (BW) and estimated glomerular filtration rate (eGFR', 'urinary albumin excretion', 'EQW changed albuminuria', 'EQW versus oral glucose-lowering drugs', 'EQW reduced uACR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.280552,EQW reduced uACR in patients with T2D and elevated albuminuria compared to commonly used glucose-lowering drugs.,"[{'ForeName': 'Annemarie B', 'Initials': 'AB', 'LastName': 'van der Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam UMC location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Hoogenberg', 'Affiliation': 'Department of Internal Medicine, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, Maryland.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14067']
248,32227754,Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.,"BACKGROUND


In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2  or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.
METHODS


We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy.
RESULTS


Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4).
CONCLUSIONS


Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","['Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease', 'Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease', 'participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2  or receipt of dialysis', 'Health status was assessed in 705 of 777 participants']",['guideline-based medical therapy alone (conservative strategy'],"['health status with the Seattle Angina Questionnaire (SAQ', 'frequent angina and better function and quality of life', 'overall trial population', 'SAQ Summary score', 'risk of death or myocardial infarction']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",777.0,0.272639,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916374']
249,30969910,A Comparison of Word-Recognition Performances on the Auditec and VA Recorded Versions of Northwestern University Auditory Test No. 6 by Young Listeners with Normal Hearing and by Older Listeners with Sensorineural Hearing Loss Using a Randomized Presentation-Level Paradigm.,"BACKGROUND


The Auditec of St. Louis and the Department of Veterans Affairs (VA) recorded versions of the Northwestern University Auditory Test No. 6 (NU-6) are in common usage. Data on young adults with normal hearing for pure tones (YNH) demonstrate equal recognition performances on the two versions when the VA version is presented 5 dB higher but similar data on older listeners with sensorineural hearing loss (OHL) are lacking.
PURPOSE


To compare word-recognition performances on the Auditec and VA versions of NU-6 presented at six presentation levels with YNH and OHL listeners.
RESEARCH DESIGN


A quasi-experimental, repeated-measures design was used.
STUDY SAMPLE


Twelve YNH (M = 24.0 years; PTA = 9.9-dB HL) and 36 OHL listeners (M = 71.6 years; PTA = 26.7-dB HL) participated in three, one-hour sessions.
DATA COLLECTION AND ANALYSES


Each listener received 100 stimulus words that were randomized by 6 presentation levels for each of two speakers (YNH, -2 to 28-dB SL; OHL, -2 to 38-dB SL). The sessions were limited to 25 practice and 400 experimental words. Digital versions of the 16, 25-word tracks for each session were alternated between speakers.
RESULTS


Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version. The respective overall recognition performances on the Auditec and VA versions were 71.4% and 64.1% (YNH) and 68.7% and 58.2% (OHL). At the highest presentation levels, recognition performances on the two versions differed by only 0.5% (YNH) and 3.3% (OHL). At the 50% correct point, performances on the Auditec version were 3.2 dB (YNH) and 6.1 dB (OHL) better than those on the VA version. The slopes at the 50% points on the mean functions for both speakers were about 4.9%/dB (YNH) and 3.0%/dB (OHL); however, the slopes evaluated from the individual listener data were steeper, 5.2 to 5.3%/dB (YNH) and 3.3 to 3.5%/dB (OHL). When the individual data were transformed from dB SL to dB HL, the differences between the two listener groups were emphasized. The four functions (2 speakers by 2 listener groups) were plotted for each of the 48 participants and each of the 200 words, which revealed the gamut of relations among the datasets. Examination of the data for each speaker across test sessions, in the traditional 50-word lists, and in the typically used 25-word lists of Randomization A revealed no differences of clinical concern. Finally, introspective reports from the listeners revealed that 91.7% and 83.3% of the YNH and OHL listeners, respectively, thought the Auditec speaker was easier to understand than the VA speaker. Recognition performances on each participant and on each word are presented.",2019,Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version.,"['older listeners with sensorineural hearing loss (OHL', '48 listeners', 'SAMPLE\n\n\nTwelve YNH (M = 24.0 years; PTA = 9.9-dB HL) and 36 OHL listeners (M = 71.6 years; PTA = 26.7-dB HL', 'Young Listeners with Normal Hearing and by Older Listeners with Sensorineural Hearing Loss', 'young adults with normal hearing for pure tones (YNH']",[],['Auditec and VA versions'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],48.0,0.0181677,Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version.,"[{'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Arizona State University, Tempe, AZ.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17135']
250,30222540,An Evaluation of Motivational Interviewing for Increasing Hearing Aid Use: A Pilot Study.,"BACKGROUND


Motivational interviewing (MI) has been used in consultation settings to motivate hearing aid users to increase hearing aid usage. However, the effect of MI on those who use their hearing aids only rarely or not at all has not been explored.
PURPOSE


The aims of this pilot study were to evaluate the effect of MI counseling with elderly hearing aid recipients found to have low hearing aid use at a six-month follow-up appointment and to describe clients' subjective assessments of their perceived need for hearing aids three months after MI counseling.
RESEARCH DESIGN


The study had a within-subjects pretest-posttest design.
STUDY SAMPLE


Forty seven hearing aid recipients who had used their new hearing aids, an average of <90 min/day, were recruited at a follow-up appointment six months after hearing aid fitting.
INTERVENTION


Thirty minutes of MI counseling was provided at the six-month follow-up appointment. If needed, hearing aid adjustments and technical support were also provided.
DATA COLLECTION AND ANALYSIS


The effect of MI counseling in combination with adjustments and technical support was assessed in relation to datalogged hearing aid use, which was assessed immediately before (at the six-month follow-up) and three months after (at the nine-month follow-up) the intervention. Hearing aid experiences were also assessed three months after MI.
RESULTS


Thirty seven participants (79%) returned for the nine-month follow-up visit and had modest but significant increases in datalogged hearing aid use in the three months following MI counseling. Of the 37 participants who returned, 51% had increased their hearing aid use to at least 2 h/day after the MI counseling. Most of the 37 participants who attended the nine-month follow-up reported increased need for (59%) or increased benefit and contentment with (57%) their hearing aid three months after MI; these participants also had significantly higher datalogged hearing aid use following MI.
CONCLUSIONS


These findings suggest that follow-up appointments using MI counseling in conjunction with technical support may be useful for increasing hearing aid usage among low-users, and a randomized controlled trial is warranted.",2018,Thirty seven participants (79%) returned for the nine-month follow-up visit and had modest but significant increases in datalogged hearing aid use in the three months following MI counseling.,"['elderly hearing aid recipients', 'Forty seven hearing aid recipients who had used their new hearing aids, an average of <90 min/day, were recruited at a follow-up appointment six months after hearing aid fitting']","['MI counseling', 'Motivational Interviewing', 'Motivational interviewing (MI']","['datalogged hearing aid use', 'Hearing aid experiences']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",47.0,0.018625,Thirty seven participants (79%) returned for the nine-month follow-up visit and had modest but significant increases in datalogged hearing aid use in the three months following MI counseling.,"[{'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Solheim', 'Affiliation': 'ENT Department, Lovisenberg Diakonale Hospital, Oslo, Norway.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Gay', 'Affiliation': 'ENT Department, Lovisenberg Diakonale Hospital, Oslo, Norway.'}, {'ForeName': 'Anners', 'Initials': 'A', 'LastName': 'Lerdal', 'Affiliation': 'ENT Department, Lovisenberg Diakonale Hospital, Oslo, Norway.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hickson', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kari J', 'Initials': 'KJ', 'LastName': 'Kvaerner', 'Affiliation': 'C3 Centre for Connected Care, Oslo University Hospital, Oslo, Norway.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.16184']
251,32324471,Effects of alternating blood flow restricted training and heavy-load resistance training on myofiber morphology and mechanical muscle function.,"To investigate if short-term block-structured training consisting of alternating weeks of blood flow restricted low-load resistance training (BFR-RT) and conventional free-flow heavy-load resistance training (HL-RT) leads to superior gains in mechanical muscle function, myofiber size, and satellite cell (SC) content and myonuclear number compared with HL-RT alone. Eighteen active young participants (women/men: 5/13, 23 ± 1.2 yr) were randomized to 6 wk (22 sessions) of lower limb HL-RT [70-90% one repetition maximum (1-RM)] (HRT,  n  = 9) or block-structured training alternating weekly between BFR-RT (20% 1-RM) and HL-RT (BFR-HRT,  n  = 9). Maximal isometric knee extensor strength (MVC) and muscle biopsies (VL) were obtained pre- and posttraining to examine changes in muscle strength, myofiber cross-sectional area (CSA), myonuclear (MN) number, and SC content. MVC increased in both training groups (BFR-HRT: +12%, HRT: +7%;  P  < 0.05). Type II myofiber CSA increased similarly (+16%) in BFR-HRT and HRT ( P  < 0.05), while gains in type I CSA were observed following HRT only (+12%,  P  < 0.05). In addition, myonuclear number remained unchanged, whereas SC content increased in type II myofibers following HRT (+59%,  P  < 0.05). Short-term alternating BFR-RT and HL-RT did not produce superior gains in muscle strength or myofiber size compared with HL-RT alone. Noticeably, however, conventional HL-RT could be periodically replaced by low-load BFR-RT without compromising training-induced gains in maximal muscle strength and type II myofiber size, respectively. NEW & NOTEWORTHY  The present data demonstrate that periodically substituting heavy-load resistance training (HL-RT) with low-load blood flow restricted resistance training (BFR-RT) leads to similar gains in type II myofiber CSA and muscle strength as achieved by HL-RT alone. Furthermore, we have for the first time evaluated myonuclear content and myonuclear domain size before and after training intervention across separate fiber size clusters and found no within-cluster changes for these parameters with training.",2020,"CONCLUSIONS


Short-term alternating BFR-RT and HL-RT did not produce superior gains in muscle strength or myofiber size compared to HL-RT alone.","['Eighteen active young participants (females/males: 5/13, 23±1.2yrs']","['conventional HL-RT', 'Maximal isometric knee extensor strength (MVC) and muscle biopsies(VL)were obtained pre and post training', 'lower limb HL-RT (70-90% 1-RM) (HRT, n= 9) or block-structured training alternating weekly between BFR-RT (20% 1-RM) and HL-RT', 'alternating blood-flow restricted training and heavy-load resistance training', 'short-term block-structured training consisting of alternating weeks of blood-flow restricted low-load resistance training (BFR-RT) and conventional free-flow heavy-load resistance training (HL-RT']","['muscle strength, myofiber cross-sectional area (CSA), myonuclear (MN) number and satellite cell (SC) content', 'mechanical muscle function, myofiber size and satellite cell (SC) content and myonuclear number', 'MVC', 'SC content', 'BFR-HRT and HRT', 'myofiber morphology and mechanical muscle function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205868', 'cui_str': 'Perineuronal satellite cell'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",18.0,0.0116764,"CONCLUSIONS


Short-term alternating BFR-RT and HL-RT did not produce superior gains in muscle strength or myofiber size compared to HL-RT alone.","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Hansen', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ratzer', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Nielsen', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Suetta', 'Affiliation': 'Geriatric Research Unit, Bispebjerg-Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karlsen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kvorning', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Frandsen', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00015.2020']
252,32326538,"Improving Mental Performance in an Athletic Population with the Use of Ārepa ® , a Blackcurrant Based Nootropic Drink: A Randomized Control Trial.","A range of dietary bioactive ingredients have claimed to improve mental clarity and reduce fatigue, including blackcurrant, pine bark, and l-theanine. These active ingredients provide a good source of dietary polyphenols which could be useful in reducing mental fatigue in a sports setting. The aim of the investigation was to test the effect of Ārepa ®  a blackcurrant-based nootropic-drink also containing pine-bark and l-theanine (BC+), on mental clarity in a sport setting. Twenty-three rugby league players completed a cross-over design, randomized, double-blind, controlled trial. Intervention and control phases lasted 7 days, with a washout in between. Cognition was assessed pre and post intervention following a standardized training session. Our study found the total score, accuracy, and average time per response scores improved significantly more after drinking the BC+ drink ( p  = 0.001, 0.003, and 0.043 respectively). The BC+ improved the perception that participants were reliable ( p  = 0.02) and less distracted ( p  = 0.03), while placebo supplementation increased participant perception they could control their nervousness ( p  = 0.03). Thematic analysis of post-trial questionnaire indicated participants found the BC+ sour, most reported no side effects, and opinion on which drink was more effective was not unanimous. The results indicate that the BC+ drink may be useful for athletes.",2020,"The BC+ improved the perception that participants were reliable ( p  = 0.02) and less distracted ( p  = 0.03), while placebo supplementation increased participant perception they could control their nervousness ( p  = 0.03).","['Athletic Population with the Use of Ārepa ® , a Blackcurrant Based Nootropic Drink', 'Twenty-three rugby league players']",['Ārepa ®  a blackcurrant-based nootropic-drink also containing pine-bark and l-theanine (BC'],"['total score, accuracy, and average time per response scores', 'mental fatigue']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242913', 'cui_str': 'Antidementia agent'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242913', 'cui_str': 'Antidementia agent'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330186', 'cui_str': 'Pinus'}, {'cui': 'C0076380', 'cui_str': 'theanine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}]",,0.338376,"The BC+ improved the perception that participants were reliable ( p  = 0.02) and less distracted ( p  = 0.03), while placebo supplementation increased participant perception they could control their nervousness ( p  = 0.03).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Science, The University of Auckland, Auckland 1010, New Zealand.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'High Performance Sport, AUT Millenium, Auckland 0632, New Zealand.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sharples', 'Affiliation': 'Vodafone Warriors Rugby League, Mt Smart Stadium, 2 Beasley Avenue, Auckland 1061, New Zealand.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Braakhuis', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Science, The University of Auckland, Auckland 1010, New Zealand.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9040316']
253,30885692,Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial.,"BACKGROUND


A preventive vaccine for HIV is a crucial public health need; adeno-associated virus (AAV)-mediated antibody gene delivery could be an alternative to immunisation to induce sustained expression of neutralising antibodies to prevent HIV. We assessed safety and tolerability of rAAV1-PG9DP, a recombinant AAV1 vector encoding the gene for PG9, a broadly neutralising antibody against HIV.
METHODS


This first-in-human, proof-of-concept, double-blind, phase 1, randomised, placebo-controlled, dose-escalation trial was done at one clinical research centre in the UK. Healthy men aged 18-45 years without HIV infection were randomly assigned to receive intramuscular injection with rAAV1-PG9DP or placebo in the deltoid or quadriceps in one of four dose-escalating cohorts (group A, 4 × 10 12  vector genomes; group B, 4 × 10 13  vector genomes; group C, 8 × 10 13  vector genomes; and group D, 1·2 × 10 14  vector genomes). Volunteers were followed up for 48 weeks. The primary objective was to assess safety and tolerability. A secondary objective was to assess PG9 expression in serum and related HIV neutralisation activity. All volunteers were included in primary and safety analyses. The trial is complete and is registered with ClinicalTrials.gov, number NCT01937455.
FINDINGS


Between Jan 30, 2014, and Feb 28, 2017, 111 volunteers were screened for eligibility. 21 volunteers were eligible and provided consent, and all 21 completed 48 weeks of follow-up. Reactogenicity was generally mild or moderate and resolved without intervention. No probably or definitely related adverse events or serious adverse events were recorded. We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers. We did not detect PG9 by ELISA in serum. PG9 anti-drug antibody was present in ten volunteers in the higher dose groups. Both anti-AAV1 antibodies and AAV1-specific T-cell responses were detected.
INTERPRETATION


Future studies should explore higher doses of AAV, alternative AAV serotypes and gene expression cassettes, or other broadly neutralising HIV antibodies.
FUNDING


International AIDS Vaccine Initiative, United States Agency for International Development, Bill & Melinda Gates Foundation, US National Institutes of Health.",2019,"We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers.","['Healthy men aged 18-45 years without HIV infection', '21 volunteers were eligible and provided consent, and all 21 completed 48 weeks of follow-up', '1·2\u2008×', 'Between Jan 30, 2014, and Feb 28, 2017, 111 volunteers were screened for eligibility', 'healthy adults']","['intramuscular injection with rAAV1-PG9DP or placebo', 'rAAV1-PG9DP', 'Adeno-associated virus vectored immunoprophylaxis', 'placebo']","['adverse events or serious adverse events', 'safety and tolerability', 'PG9 expression in serum and related HIV neutralisation activity', 'Reactogenicity', 'PG9 anti-drug antibody']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",111.0,0.266159,"We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers.","[{'ForeName': 'Frances H', 'Initials': 'FH', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA. Electronic address: fpriddy@iavi.org.'}, {'ForeName': 'David J M', 'Initials': 'DJM', 'LastName': 'Lewis', 'Affiliation': 'NIHR Imperial Clinical Research Facility, Imperial College, London UK.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Hassanin', 'Affiliation': 'Surrey Clinical Research Centre, University of Surrey, Guildford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Streatfield', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'LaBranche', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hare', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Bendel', 'Affiliation': 'Surrey Clinical Research Centre, University of Surrey, Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Sayeed', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ackland', 'Affiliation': 'Global Biosolutions, Melbourne, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilmour', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Schnepp', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'J Fraser', 'Initials': 'JF', 'LastName': 'Wright', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': ""Children's Hospital of Philadelphia.""}]",The lancet. HIV,['10.1016/S2352-3018(19)30003-7']
254,31274072,Skill Transference of a Probe-Tube Placement Training Simulator.,"BACKGROUND


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


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


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


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


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


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


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


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


Results suggested students in the simulator group were less likely to contact the tympanic membrane when placing a probe tube, appeared more confident, and had better use of the occluding foam tip, resulting in more improved RECD measurements.
","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Koch', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Saleh', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Folkeard', 'Affiliation': 'National Centre for Audiology, Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Moodie', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Conner', 'Initials': 'C', 'LastName': 'Janeteas', 'Affiliation': 'Cimetrix Solutions Inc., Oshawa, ON, Canada.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Agrawal', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Hanif M', 'Initials': 'HM', 'LastName': 'Ladak', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Scollie', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18054']
255,32328709,"Correction to: A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",2020,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",[],"['drospirenone-only pill 4\xa0mg over nine cycles in comparison with desogestrel 0.075\xa0mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor', 'desogestrel 0.075\xa0mg', 'drospirenone']",[],[],"[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",[],,0.264965,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud Y Medicina de La Mujer, C/Antonio Acuña, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05544-z']
256,30323176,The impact of using a malnutrition screening tool in a hospital setting: a mixed methods study.,"BACKGROUND/OBJECTIVES


Malnutrition risk screening represents a crucial starting point for the successful management of malnourished patients. This study was conducted to (1) examine the effect of the use of a malnutrition screening tool on process indicators of nutritional care and (2) explore healthcare professionals' perceptions and opinions regarding this tool.
METHODS


A mixed methods design was used. A controlled pretest-posttest study was conducted to carry out quantitative analyses, and semi-structured, qualitative interviews were held. Quantitative data were analysed with descriptive statistics, Chi-squared tests, Student's t-tests and Kruskal-Wallis H tests, using SPSS 23. Qualitative data were analysed by performing a qualitative content analysis using MAXQDA 12. Two comparable hospitals participated in the study, representing one intervention group (IG) and one control group (CG). The Graz Malnutrition Screening Tool (GMS) was implemented and used in the IG for at least 1 month, while the CG received no intervention.
RESULTS


The use of the screening tool positively correlated with significant improvements in the process indicators of nutritional care after 1 month, in terms of the number of nutritional interventions and the frequency of documentation of the diagnosis and the patient's weight and height. The content of the interviews revealed that nearly all professionals involved perceived the overall screening process positively. Few barriers were identified.
CONCLUSIONS


The results of this study show that the use of a screening tool has a positive, short-term impact on the hospital's process quality of nutritional care. Ongoing efforts are required to sustainably maintain these positive changes. During this process, positive attitudes, nomination of motivated 'opinion-leaders' and concerted management support are helpful facilitators.",2019,"The use of the screening tool positively correlated with significant improvements in the process indicators of nutritional care after 1 month, in terms of the number of nutritional interventions and the frequency of documentation of the diagnosis and the patient's weight and height.",['malnourished patients'],['malnutrition screening tool'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0740214', 'cui_str': 'Malnutrition screening (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",[],,0.0344751,"The use of the screening tool positively correlated with significant improvements in the process indicators of nutritional care after 1 month, in terms of the number of nutritional interventions and the frequency of documentation of the diagnosis and the patient's weight and height.","[{'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Eglseer', 'Affiliation': 'Institute of Nursing Science, Medical University of Graz, Graz, Austria. doris.eglseer@medunigraz.at.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schoberer', 'Affiliation': 'Institute of Nursing Science, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Halfens', 'Affiliation': 'Department of Health Services Research, CAPHRI, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Lohrmann', 'Affiliation': 'Institute of Nursing Science, Medical University of Graz, Graz, Austria.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0339-z']
257,30430984,Effect of Intensity Level and Speech Stimulus Type on the Vestibulo-Ocular Reflex.,"BACKGROUND


Accurate vestibulo-ocular reflex (VOR) measurement requires control of extravestibular suppressive factors such as visual fixation. Although visual fixation is the dominant suppressor and has been extensively studied, the mechanisms underlying suppression from nonvisual factors of attention and auditory stimulation are less clear. It has been postulated that the nonvisual suppression of the VOR is the result of one of two mechanisms: (1) activation of auditory reception areas excites efferent pathways to the vestibular nuclei, thus inhibiting the VOR or (2) cortical modulation of the VOR results from directed attention, which implies a nonmodality-specific process.
PURPOSE


The purpose of this research was to determine if the VOR is affected by the intensity level and/or type of speech stimulus.
RESEARCH DESIGN


A repeated measures design was used. The experiment was single-blinded.
STUDY SAMPLE


Participants included 17 adults (14 females, three males) between the ages of 18-34 years who reported normal oculomotor, vestibular, neurological, and musculoskeletal function.
DATA COLLECTION AND ANALYSIS


Each participant underwent slow harmonic acceleration testing in a rotational chair. VOR gain was assessed at 0.02, 0.08, and 0.32 Hz in quiet (baseline). VOR gain was also assessed at each frequency while a forward running speech stimulus (attentional) or a backward running speech stimulus (nonattentional) was presented binaurally via insert earphones at 42, 62, and 82 dBA. The order of the conditions was randomized across participants. VOR difference gain was calculated as VOR gain in the auditory condition minus baseline VOR gain. To evaluate auditory efferent function, the medial olivocochlear reflex (MOCR) was assayed using transient-evoked otoacoustic emissions (right ear) measured in the presence and absence of broadband noise (left ear). Contralateral acoustic reflex thresholds were also assessed using a broadband noise elicitor. A three-way repeated measures analysis of variance was conducted to evaluate the effect of frequency, intensity level, and speech type on VOR difference gain. Correlations were conducted to determine if difference gain was related to the strength of the MOCR and/or to the acoustic reflex threshold.
RESULTS


The analysis of variance indicated that VOR difference gain was not significantly affected by the intensity level or the type of speech stimulus. Correlations indicated VOR difference gain was not significantly related to the strength of the MOCR or the acoustic reflex threshold.
CONCLUSIONS


The results were in contrast to previous research examining the effect of auditory stimulation on VOR gain as auditory stimulation did not produce VOR suppression or enhancement for most of the participants. Methodological differences between the studies may explain the discrepant results. The removal of an acoustic target from space to attend to may have prevented suppression or enhancement of the VOR. Findings support the hypothesis that VOR gain may be affected by cortical modulation through directed attention rather than due to activation of efferent pathways to the vestibular nuclei.",2019,The analysis of variance indicated that VOR difference gain was not significantly affected by the intensity level or the type of speech stimulus.,"['Participants included 17 adults (14 females, three males) between the ages of 18-34 years who reported normal oculomotor, vestibular, neurological, and musculoskeletal function']",['slow harmonic acceleration testing'],"['Contralateral acoustic reflex thresholds', 'strength of the MOCR or the acoustic reflex threshold', 'frequency, intensity level, and speech type on VOR difference gain', 'medial olivocochlear reflex (MOCR', 'VOR difference gain', 'VOR gain', 'VOR suppression']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0034934', 'cui_str': 'Reflex, Acoustic'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",17.0,0.069504,The analysis of variance indicated that VOR difference gain was not significantly affected by the intensity level or the type of speech stimulus.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Easterday', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Plyler', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lewis', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Doettl', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18016']
258,30461405,Difference in Speech Recognition between a Default and Programmed Telecoil Program.,"BACKGROUND


Hearing loss can lead to isolation and social withdrawal. The telephone oftentimes connects persons with hearing loss to society; however, telephone use is impeded by narrow bandwidth, loss of visual cues, electromagnetic interference, and inherent phone-line noise. In the past, research assessing telephone communication has consistently reported that switching from the microphone to a telecoil will typically result in the acoustic signal being discernibly softer. Properly used telecoils improve the signal-to-noise ratio (SNR), decrease the chance for acoustic feedback, and overcome the impact of distance and reverberation creating an opportunity for clearer telephone communication. Little research, however, has examined matching the telecoil frequency response to the prescribed target of the microphone frequency response (National Acoustics Laboratories, Non-Linear, version 1 [NAL-NL1]).
PURPOSE


The primary goal of this study was to determine if differences exist in speech recognition for sentences (AZ-BIO) and consonant-vowel nucleus-consonant monosyllabic words (CNC) between two telecoil conditions (default and programmed). A secondary goal was to determine if differences exist in speech recognition for sentences between male and female talkers.
RESEARCH DESIGN


A single-blinded randomized controlled trial.
STUDY SAMPLE


Twenty experienced adult hearing aid users with bilateral symmetric slight to severe sensorineural hearing loss were recruited from Washington University in St. Louis School of Medicine. In addition, ten normal-hearing participants were recruited to determine the presentation level of the speech stimuli for the hearing aid participants.
DATA COLLECTION AND ANALYSIS


Participants underwent real-ear measures to program the microphone frequency response of a receiver-in-the-canal hearing aid to NAL-NL1. Using the manufacturer software, one telecoil program remained as the manufacturer default and a second telecoil program was programmed so the sound pressure level for an inductive telephone simulator frequency response matching the microphone's frequency response to obtain as close to a 0 dB relative simulated equivalent telephone sensitivity value as possible. Participants then completed speech recognition measures including AZ-BIO sentences (male and female talkers) and CNC monosyllabic words and phonemes, using both telecoil programs. A mixed model analysis was performed to examine if significant differences in speech recognition exist between the two conditions and speech stimuli.
RESULTS


Results revealed significant improvement in overall speech recognition for the programmed telecoil performance compared with default telecoil performance (p < 0.001). Also, improved performance in the programmed telecoil was reported with a male talker (p < 0.001) and performance for sentences compared with monosyllabic words (p < 0.001) or phonemes (p < 0.001).
CONCLUSIONS


The programmed telecoil condition revealed significant improvement in speech recognition for all speech stimuli conditions compared with the default telecoil (sentences, monosyllables, and phonemes). Additional improvement was observed in both telecoil conditions when the talker was male.",2019,"Properly used telecoils improve the signal-to-noise ratio (SNR), decrease the chance for acoustic feedback, and overcome the impact of distance and reverberation creating an opportunity for clearer telephone communication.","['ten normal-hearing participants', 'Twenty experienced adult hearing aid users with bilateral symmetric slight to severe sensorineural hearing loss were recruited from Washington University in St. Louis School of Medicine']",[],"['signal-to-noise ratio (SNR', 'telecoil conditions', 'speech recognition', 'overall speech recognition', 'speech recognition for sentences (AZ-BIO) and consonant-vowel nucleus-consonant monosyllabic words (CNC', 'Speech Recognition', 'AZ-BIO sentences (male and female talkers) and CNC monosyllabic words and phonemes']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",[],"[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",20.0,0.0366592,"Properly used telecoils improve the signal-to-noise ratio (SNR), decrease the chance for acoustic feedback, and overcome the impact of distance and reverberation creating an opportunity for clearer telephone communication.","[{'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Ledda', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Valente', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Oeding', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Kallogjeri', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17128']
259,31859172,Active Children Through Individual Vouchers Evaluation: A Mixed-Method RCT.,"INTRODUCTION


Physical activity declines in adolescence, especially among those in deprived areas. Research suggests this may result from accessibility barriers (e.g., cost and locality). The Active Children Through Individual Vouchers Evaluation RCT aimed to improve the fitness and heart health of teenagers in Wales with the help of teenagers who co-produced the study.
STUDY DESIGN


This study was a mixed-method RCT.
SETTING/PARTICIPANTS


Before data collection, which took place at baseline, 6 months, and 12 months for both arms, 7 schools were randomized by an external statistician (4 intervention schools, n=524; 3 control schools, n=385).
INTERVENTION


The Active Children Through Individual Vouchers Evaluation intervention included provision of activity vouchers (£20 per month), a peer mentoring scheme, and support worker engagement for 12 months between January and December 2017. Data analysis occurred February-April 2018.
MAIN OUTCOME MEASURES


Data included measures of cardiovascular fitness, cardiovascular health (blood pressure and pulse wave analysis), motivation, and focus groups.
RESULTS


The intervention showed a trend to improve the distance ran (primary outcome) and was significant in improving the likelihood of intervention teenagers being fit (OR=1.21, 95% CI=1.07, 1.38, p=0.002). There was a reduction in teenagers classified as having high blood pressure (secondary outcome) in the intervention group (baseline, 5.3% [28/524]; 12 months, 2.7% [14/524]). Data on where teenagers used vouchers and evidence from focus groups showed that teenagers wanted to access more unstructured, informal, and social activities in their local areas.
CONCLUSIONS


Active Children Through Individual Vouchers Evaluation identified methods that may have a positive impact on cardiovascular fitness, cardiovascular health, and perspectives of activity. Consulting with teenagers, empowering them, and providing more local opportunities for them to take part in activities that are fun, unstructured, and social could positively impact teenage physical activity.
TRIAL REGISTRATION


ISRCTN, ISRCTN75594310.",2020,"The intervention showed a trend to improve the distance ran (primary outcome) and was significant in improving the likelihood of intervention teenagers being fit (OR=1.21, 95% CI=1.07, 1.38, p=0.002).","['teenagers in Wales with the help of teenagers who co-produced the study', 'Active Children Through Individual Vouchers Evaluation', 'Before data collection, which took place at baseline, 6 months, and 12 months for both arms, 7 schools were randomized by an external statistician (4 intervention schools, n=524; 3 control schools, n=385', 'Active Children']",[],"['blood pressure', 'cardiovascular fitness, cardiovascular health (blood pressure and pulse wave analysis), motivation, and focus groups']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0334957', 'cui_str': 'Statistician (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]",,0.0574726,"The intervention showed a trend to improve the distance ran (primary outcome) and was significant in improving the likelihood of intervention teenagers being fit (OR=1.21, 95% CI=1.07, 1.38, p=0.002).","[{'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'James', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom. Electronic address: m.l.james@swansea.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Christian', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Scott', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Todd', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'College of Engineering, Bay Campus, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Demmler', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McCoubrey', 'Affiliation': 'City and County of Swansea, Swansea, United Kingdom.'}, {'ForeName': 'Julian P J', 'Initials': 'JPJ', 'LastName': 'Halcox', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Audrey', 'Affiliation': 'Population Health Sciences, Bristol, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ellins', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Sinead T', 'Initials': 'ST', 'LastName': 'Brophy', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.10.005']
260,31526469,Long-Term Effects of a Multimodal Physiotherapy Program on the Severity of Somatosensory Tinnitus and Identification of Clinical Indicators Predicting Favorable Outcomes of the Program.,"BACKGROUND


Tinnitus, the perception of sound in the absence of external auditory stimuli, is commonly associated with problems of the auditory system. Head and neck disorders can also be involved in tinnitus emergence. In such cases, the term somatosensory tinnitus is used. Physiotherapy treatments have been identified as a promising avenue in the treatment of somatosensory tinnitus.
PURPOSE


The aim of the study was to explore the effect of a physiotherapy program on the intensity and severity of somatosensory tinnitus and to identify the clinical characteristics of the patients who respond well to this treatment.
RESEARCH DESIGN


Quasi-experimental pre-post single-group design.
STUDY SAMPLE


Thirty-one adults with presumed somatosensory tinnitus.
INTERVENTION


All participants received on average ten physiotherapy treatments over six weeks. Treatments included cervical and thoracic mobilizations, as well as muscular strengthening, stretching, postural instruction, and cervical stabilization.
DATA COLLECTION AND ANALYSIS


Outcomes were measured at baseline, at the end of the physiotherapy program, and three months later. The primary outcomes were the Tinnitus Handicap Inventory and visual analog scales for loudness and annoyance caused by tinnitus. After the last evaluation, participants were divided into two groups: improved and unimproved participants. Participants were considered improved if they (1) showed significant improvement in at least two of the three primary outcome measures and (2) indicated subjective improvement. Thereafter, the baseline characteristics that correctly identify participants susceptible to improve significantly following treatment were determined (Cohen's effect size d > 0.8).
RESULTS


A significant improvement in tinnitus intensity was observed at the end of the program. Of the 31 participants, 14 experienced persistent improvement in the intensity of their tinnitus and were classified as improved. Baseline characteristics strongly associated with tinnitus improvement were no increase in tinnitus when exposed to noise (d = -1.57), no family history of tinnitus (d = -1.16), somatosensory modulation in response to the contraction used to resist pressure applied to the forehead (d = 1.20), and recent onset of tinnitus (d = 1.03).
CONCLUSIONS


This exploratory study showed that a multimodal physiotherapy program is effective in decreasing the severity of tinnitus, principally in individuals presenting with somatosensory tinnitus in combination with specific clinical characteristics.",2019,"Baseline characteristics strongly associated with tinnitus improvement were no increase in tinnitus when exposed to noise (d = -1.57), no family history of tinnitus (d = -1.16), somatosensory modulation in response to the contraction used to resist pressure applied to the forehead (d = 1.20), and recent onset of tinnitus (d = 1.03).
","['patients who respond well to this treatment', 'individuals presenting with somatosensory tinnitus in combination with specific clinical characteristics', 'Thirty-one adults with presumed somatosensory tinnitus']","['physiotherapy program', 'multimodal physiotherapy program', 'Multimodal Physiotherapy Program']","['subjective improvement', 'Tinnitus Handicap Inventory and visual analog scales for loudness and annoyance caused by tinnitus', 'intensity of their tinnitus', 'intensity and severity of somatosensory tinnitus', 'tinnitus intensity', 'cervical and thoracic mobilizations, as well as muscular strengthening, stretching, postural instruction, and cervical stabilization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",31.0,0.0563727,"Baseline characteristics strongly associated with tinnitus improvement were no increase in tinnitus when exposed to noise (d = -1.57), no family history of tinnitus (d = -1.16), somatosensory modulation in response to the contraction used to resist pressure applied to the forehead (d = 1.20), and recent onset of tinnitus (d = 1.03).
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Côté', 'Affiliation': 'Centre Intégré Universitaire de santé et services sociaux de La Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Baril', 'Affiliation': 'Centre Intégré Universitaire de santé et services sociaux de La Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Catherine-Ève', 'Initials': 'CÈ', 'LastName': 'Morency', 'Affiliation': 'Centre Intégré Universitaire de santé et services sociaux de La Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montminy', 'Affiliation': 'Centre Intégré Universitaire de santé et services sociaux de La Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Couture', 'Affiliation': 'Centre Intégré Universitaire de santé et services sociaux de La Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leblond', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Roos', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Canada.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17147']
261,30222541,"Differences in Word and Phoneme Recognition in Quiet, Sentence Recognition in Noise, and Subjective Outcomes between Manufacturer First-Fit and Hearing Aids Programmed to NAL-NL2 Using Real-Ear Measures.","BACKGROUND


The American Speech-Language-Hearing Association (ASHA) and American Academy of Audiology (AAA) have created Best Practice Guidelines for fitting hearing aids to adult patients. These guidelines recommend using real-ear measures (REM) to verify that measured output/gain of hearing aid(s) match a validated prescriptive target. Unfortunately, approximately 70-80% of audiologists do not routinely use REM when fitting hearing aids, instead relying on a manufacturer default ""first-fit"" setting. This is problematic because numerous studies report significant differences in REM between manufacturer first-fit and the same hearing aids using a REM or programmed-fit. These studies reported decreased prescribed gain/output in the higher frequencies for the first-fit compared with the programmed fit, which are important for recognizing speech. Currently, there is little research in peer-reviewed journals reporting if differences between hearing aids fitted using a manufacturer first-fit versus a programmed-fit result in significant differences in speech recognition in quiet, noise, and subjective outcomes.
PURPOSE


To examine if significant differences were present in monosyllabic word and phoneme recognition (consonant-nucleus-consonant; CNC) in quiet, sentence recognition in noise (Hearing in Noise Test; HINT), and subjective outcomes using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech, Spatial and Qualities of Hearing (SSQ) questionnaires between hearing aids fit using one manufacturer's first-fit and the same hearing aids with a programmed-fit using REM to National Acoustic Laboratories Nonlinear Version 2 (NAL-NL2) prescriptive target.
RESEARCH DESIGN


A double-blind randomized crossover design was used. Throughout the study, one investigator performed all REM whereas a second investigator measured speech recognition in quiet, noise, and scored subjective outcome measures.
STUDY SAMPLE


Twenty-four adults with bilateral normal sloping to moderately severe sensorineural hearing loss with no prior experience with amplification.
DATA COLLECTION AND ANALYSIS


The hearing aids were fit using the proprietary manufacturer default first-fit and a programmed-fit to NAL-NL2 using real-ear insertion gain measures. The order of the two fittings was randomly assigned and counterbalanced. Participants acclimatized to each setting for four weeks and returned for assessment of performance via the revised CNC word lists, HINT, APHAB, and SSQ for the respective fitting.
RESULTS


(1) A significant median advantage of 15% (p < 0.001; 95% CI: 9.7-24.3%) for words and 7.7% (p < 0.001; 95% CI: 5.9-10.9%) for phonemes for the programmed-fit compared with first-fit at 50 dB sound pressure level (SPL) and 4% (p < 0.01; 95% CI: 1.7-6.3%) for words at 65 dB SPL; (2) No significant differences for the HINT reception threshold for sentences (RTS); (3) A significant median advantage of 4.2% [p < 0.04; 95% confidence interval (CI): -0.6-13.2%] for the programmed-fit compared with the first-fit for the background noise subscale problem score for the APHAB; (4) No significant differences on the SSQ.
CONCLUSIONS


Improved word and phoneme recognition for soft and words for average speech in quiet were reported for the programmed-fit. Seventy-nine percent of the participants preferred the programmed-fitting versus first-fit. Hearing aids, therefore, should be verified and programmed using REM to a prescriptive target versus no verification using a first-fit.",2018,"CONCLUSIONS


Improved word and phoneme recognition for soft and words for average speech in quiet were reported for the programmed-fit.","['adult patients', 'SAMPLE\n\n\nTwenty-four adults with bilateral normal sloping to moderately severe sensorineural hearing loss with no prior experience with amplification']",[],"['speech recognition in quiet, noise, and scored subjective outcome measures', 'HINT reception threshold for sentences (RTS', 'Word and Phoneme Recognition in Quiet, Sentence Recognition in Noise, and Subjective Outcomes', 'monosyllabic word and phoneme recognition (consonant-nucleus-consonant; CNC) in quiet, sentence recognition in noise (Hearing in Noise Test; HINT), and subjective outcomes using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech, Spatial and Qualities of Hearing (SSQ) questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}]",[],"[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",24.0,0.0522301,"CONCLUSIONS


Improved word and phoneme recognition for soft and words for average speech in quiet were reported for the programmed-fit.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Valente', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Division of Adult Audiology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Oeding', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Division of Adult Audiology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brockmeyer', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Division of Adult Audiology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Division of Adult Audiology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Kallogjeri', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Division of Adult Audiology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17005']
262,32323437,Impact of disease duration and β-cell reserve on the efficacy of switching to iGlarLixi in adults with type 2 diabetes on glucagon-like peptide-1 receptor agonist therapy: Exploratory analyses from the LixiLan-G trial.,"AIM


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


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


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


The results of this study suggest that iGlarLixi is an effective treatment option, irrespective of C-peptide levels or duration of diabetes, in adults with insufficiently controlled T2D receiving GLP-1 RAs.",2020,A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C-peptide quartiles (51%-73% range) than in the GLP-1 RA arm (19%-32% range).,"['adults with insufficiently controlled T2D receiving GLP-1 RAs', 'adults with type 2 diabetes on GLP-1 receptor agonist therapy', 'type 2 diabetes (T2D', 'adults with T2D inadequately controlled while on']","['iGlarLixi', 'LixiLan-G', 'switching to iGlarLixi', 'glucagon-like peptide 1 receptor agonist (GLP-1 RA), with metformin, with/without pioglitazone and/or a sodium-glucose cotransporter 2 inhibitor']","['glycated hemoglobin (HbA1c', 'fasting C-peptide quartiles']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",,0.0585292,A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C-peptide quartiles (51%-73% range) than in the GLP-1 RA arm (19%-32% range).,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Medical Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Niam', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'The Rambam Academic Hospital, Haifa, Israel.'}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dex', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Souhami', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BDM Consulting Inc., Somerset, New Jersey, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, Texas, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14068']
263,32268174,Adopting for Supine Percutaneous Nephrolithotomy: Analyzing the Learning Curve of Tertiary Academic Center Urology Team.,"OBJECTIVES


To evaluate the effect of learning curve on supine mini-percutaneous nephrolithotomy (PNL) outcomes.
METHODS


The aim of the study was to include a total of 75 patients. All of the patients were operated on by the same team, which had experience of at least 100 prone mini-PNL cases. The team was led by a surgeon who had observed 40 supine conventional PNL procedures (sheath size 24 Fr) over a period of 3 months at an endourology center with experience in supine PNL and surgeries were performed by the same primary surgeon. Patients were divided equally into 5 groups, as first 15 cases in Group 1, and final 15 in Group 5. Groups were compared according to preoperative characteristic, intraoperative result, complication rate, and success rate.
RESULTS


The mean access time was 14 minutes in group 1. It decreased to mean of 10.3 minutes for cases 31 through 45, and afterward significant decrease occurred up to a mean of 6.5 minutes for cases 61 through 75 (P ≤.001). According to the Clavien-Dindo classification system, complications were assessed, and a decrease was observed from group 1 to group 5 (40%, 20%, 26.6%, 6.7%, and 13.3%, respectively). The stone free rate increased from the mean of 66.7% for the first two groups to 80% for group 3 and increase up to the 93.3% for group 4 and 5 (P = .128).
CONCLUSION


The present study showed that considering the decrease in access time and operation time 60 patients could be enough for surgical competency as well as the complications and stone-free rates reached satisfactory levels after 45 patients.",2020,"The stone free rate increased from the mean of 66.7% for the first two groups to 80% for group 3 and increase up to the 93.3% for group 4 and 5 (p=0.128).
","['75 patients', 'patients were operated on by the same team, which had experience of at least 100 prone mini-PNL cases']","['learning curve on supine mini-percutaneous nephrolithotomy (PNL', 'Supine Percutaneous Nephrolithotomy']","['mean access time', 'stone free rate', 'complication rate and success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",75.0,0.0189344,"The stone free rate increased from the mean of 66.7% for the first two groups to 80% for group 3 and increase up to the 93.3% for group 4 and 5 (p=0.128).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey. Electronic address: muratsahan87@hotmail.com.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Caglar', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ozgor', 'Affiliation': 'Department of Urology, Haseki Teaching and Research Hospital, Istanbul, Turkey.'}]",Urology,['10.1016/j.urology.2020.03.022']
264,31974691,Refining the criteria for immediate total-body CT after severe trauma.,"OBJECTIVES


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


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


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


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


• Selection criteria for iTBCT can be reduced to 10 clinically useful criteria. • This reduces radiation exposure in 36% of less severely injured patients. • Overall discriminative capacity for selection of severely injured patients remained equal.",2020,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"['1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15', 'severe trauma patients']","['iTBCT or conventional imaging and selective CT', 'conventional imaging and selective CT scanning']","['Positive predictive value', 'Sensitivity', 'radiation exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",1083.0,0.196791,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"[{'ForeName': 'Kaij', 'Initials': 'K', 'LastName': 'Treskes', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. k.treskes@amsterdamumc.nl.'}, {'ForeName': 'Teun P', 'Initials': 'TP', 'LastName': 'Saltzherr', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, Den Haag, the Netherlands.'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edwards', 'Affiliation': 'Trauma Unit, Department of Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Benn J A', 'Initials': 'BJA', 'LastName': 'Beuker', 'Affiliation': 'Trauma Unit, Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': ""Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hohmann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Basel Hospital, Petersgraben, 4031, Basel, Switzerland.'}, {'ForeName': 'Jan S K', 'Initials': 'JSK', 'LastName': 'Luitse', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anaesthesiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit/Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06503-2']
265,31365298,"Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial.","Rationale:  Less invasive, nonsurgical approaches are needed to treat severe emphysema. Objectives:  To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management. Methods:  In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). Measurements and Main Results:  The primary efficacy outcome was the difference in mean FEV 1  from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV 1  responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment ( n  = 113) or control ( n  = 59). Mean FEV 1  showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060-0.141) and 0.099 L (95% BCI, 0.048-0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax. Conclusions:  In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).",2019,"Mean FEV 1  showed statistically significant improvements between the treatment and control groups - between-group difference at 6 and 12 months, respectively of 0.101 liters (95% BCI: 0.060, 0.141) and 0.099 liters (95% BCI: 0.048, 0.151).","['patients with severe heterogeneous emphysema', 'Between October 2013 and May 2017, 172 participants (53.5% male, mean age 67.4', 'subjects aged ≥40 years with severe, heterogeneous emphysema', 'Severe Heterogenous Emphysema with the Spiration® Valve System (EMPROVE']","['Spiration ®  Valve System', 'Spiration Valve System with medical management (treatment) or medical management alone (control']","['multiple efficacy outcomes', 'FEV 1  responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity', 'mean forced expiratory volume in 1 second (FEV 1 ', 'incidence of composite thoracic serious adverse events', 'effectiveness and safety', 'minute walk distance', 'Mean FEV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention (morphologic abnormality)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",172.0,0.132759,"Mean FEV 1  showed statistically significant improvements between the treatment and control groups - between-group difference at 6 and 12 months, respectively of 0.101 liters (95% BCI: 0.060, 0.141) and 0.099 liters (95% BCI: 0.048, 0.151).","[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Delage', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Hôpital Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Voelker', 'Affiliation': 'Sarasota Memorial Hospital, Sarasota, Florida.'}, {'ForeName': 'D Kyle', 'Initials': 'DK', 'LastName': 'Hogarth', 'Affiliation': 'University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Majid', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zgoda', 'Affiliation': 'Carolinas Medical Center (Atrium Health), Charlotte, North Carolina.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Lazarus', 'Affiliation': 'Michael E. DeBakey Veterans Affairs (VA) Medical Center, Dallas, Texas.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Casal', 'Affiliation': 'Michael E. DeBakey Veterans Affairs (VA) Medical Center, Dallas, Texas.'}, {'ForeName': 'Sadia B', 'Initials': 'SB', 'LastName': 'Benzaquen', 'Affiliation': 'University of Cincinnati Hospital, Cincinnati, Ohio.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Holladay', 'Affiliation': 'Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wellikoff', 'Affiliation': 'Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Calero', 'Affiliation': 'Tampa General Hospital, University South Florida, Tampa, Florida.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Rumbak', 'Affiliation': 'Tampa General Hospital, University South Florida, Tampa, Florida.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Branca', 'Affiliation': 'University of Tennessee Medical Center, Knoxville, Tennessee.'}, {'ForeName': 'Muhanned', 'Initials': 'M', 'LastName': 'Abu-Hijleh', 'Affiliation': 'University of Texas Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Mallea', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, Florida.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kalhan', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Sachdeva', 'Affiliation': 'University of Maryland Medical Center, Baltimore, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Kinsey', 'Affiliation': 'University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Carla R', 'Initials': 'CR', 'LastName': 'Lamb', 'Affiliation': 'Lahey Hospital & Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Reed', 'Affiliation': 'Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Wissam B', 'Initials': 'WB', 'LastName': 'Abouzgheib', 'Affiliation': 'Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Phillip V', 'Initials': 'PV', 'LastName': 'Kaplan', 'Affiliation': 'Detroit Clinical Research Center, Beaumont Botsford Hospital, Farmington Hills, Michigan.'}, {'ForeName': 'Gregory X', 'Initials': 'GX', 'LastName': 'Marrujo', 'Affiliation': 'Kaiser Permanente Riverside Medical Center, Riverside, California.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnstone', 'Affiliation': 'Froedtert Hospital, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Mario G', 'Initials': 'MG', 'LastName': 'Gasparri', 'Affiliation': 'Froedtert Hospital, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Arturo A', 'Initials': 'AA', 'LastName': 'Meade', 'Affiliation': 'Sparks Regional Medical Center, Fort Smith, Arkansas.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Hergott', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Chakravarthy', 'Initials': 'C', 'LastName': 'Reddy', 'Affiliation': 'University of Utah Health Sciences, Salt Lake City, Utah.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Amy Hajari', 'Initials': 'AH', 'LastName': 'Case', 'Affiliation': 'Piedmont Hospital, Atlanta, Georgia.'}, {'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Makani', 'Affiliation': 'University of California Medical Center at San Diego, San Diego, California.'}, {'ForeName': 'Ray W', 'Initials': 'RW', 'LastName': 'Shepherd', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Benson', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'California Pacific Medical Center, San Francisco, California; and.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Holt', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Martel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Hôpital Laval, Quebec, Quebec, Canada.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201902-0383OC']
266,30395532,Risk Assessment of Recreational Noise-Induced Hearing Loss from Exposure through a Personal Audio System-iPod Touch.,"BACKGROUND


Recreational noise-induced hearing loss (RNIHL) is a major health issue and presents a huge economic burden on society. Exposure to loud music is not considered hazardous in our society because music is thought to be a source of relaxation and entertainment. However, there is evidence that regardless of the sound source, frequent exposure to loud music, including through personal audio systems (PAS), can lead to hearing loss, tinnitus, difficulty processing speech, and increased susceptibility to age-related hearing loss.
PURPOSE


Several studies have documented temporary threshold shifts (TTS) (a risk indicator of future permanent impairment) in subjects that listen to loud music through their PAS. However, there is not enough information regarding volume settings that may be considered to be safe. As a primary step toward quantifying the risk of RNIHL through PAS, we assessed changes in auditory test measures before and after exposure to music through the popular iPod Touch device set at various volume levels.
RESEARCH DESIGN


This project design incorporated aspects of both between- and within-subjects and used repeated measures to analyze individual groups.
STUDY SAMPLE


A total of 40 adults, aged 18-31 years with normal hearing were recruited and randomly distributed to four groups. Each group consisted of five males and five females.
DATA COLLECTION AND ANALYSIS


Subjects underwent two rounds of testing (pre- and postmusic exposure), with a 30-min interval, where they listened to a playlist consisting of popular songs through an iPod at 100%, 75%, 50%, or 0% volume (no music). Based on our analysis on the Knowles Electronic Manikin for Acoustic Research, with a standardized 711 coupler, it was determined that listening to the playlist for 30 min through standard earbuds resulted in an average level of 97.0 dBC at 100% volume, 83.3 dBC at 75% volume, and 65.6 dBC at 50% volume. Pure-tone thresholds from 500-8000 Hz, extended high-frequency pure tones between 9-12.5 kHz, and distortion product otoacoustic emissions (DPOAE) were obtained before and after the 30-min music exposure. Analysis of variance (ANOVA) was performed with two between-subjects factors (volume and gender) and one within-subjects factor (frequency). Change (shift) in auditory test measures was used as the outcome for the ANOVA.
RESULTS


Results indicated significant worsening of pure-tone thresholds following music exposure only in the group that was exposed to 100% volume at the following frequencies: 2, 3, 4, 6 and 8 kHz. DPOAEs showed significant decrease at 2000 and 2822 Hz, also only for the 100% volume condition. No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions. Follow-up evaluations conducted a week later indicated that pure-tone thresholds had returned to the premusic exposure levels.
CONCLUSIONS


These results provide quantifiable information regarding safe volume control settings on the iPod Touch with standard earbuds. Listening to music using the iPod Touch at 100% volume setting for as little as 30 min leads to TTS and worsening of otoacoustic emissions, a risk for permanent auditory damage.",2019,"No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions.","['subjects that listen to loud music through their PAS', '40 adults, aged 18-31 years with normal hearing', 'Subjects underwent two rounds of testing (pre- and postmusic exposure']","['Recreational noise-induced hearing loss (RNIHL', 'Recreational Noise-Induced Hearing Loss from Exposure through a Personal Audio System-iPod Touch']","['Change (shift) in auditory test measures', 'pure-tone thresholds', 'pre- and postmusic exposure measures']","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2350434', 'cui_str': 'iPOD'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",40.0,0.041616,"No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions.","[{'ForeName': 'Kamakshi V', 'Initials': 'KV', 'LastName': 'Gopal', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Liana E', 'Initials': 'LE', 'LastName': 'Mills', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Bryce S', 'Initials': 'BS', 'LastName': 'Phillips', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nandy', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of North Texas Health Science Center, Fort Worth, TX.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17140']
267,31210635,Tinnitus Sound Therapy Trial Shows Effectiveness for Those with Tinnitus.,"BACKGROUND


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


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


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


18 adults with subjective, nonpulsatile, sensorineural tinnitus.
INTERVENTION


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


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


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


This study demonstrates the benefit of partial masking, encouraging patients to seek help from audiologists interested in providing support for tinnitus patients.",2020,"On the total score of the TPFQ, 5 of 15 remaining participants (33%) showed a benefit.","['tinnitus patients', '18 adults with subjective, nonpulsatile, sensorineural tinnitus', 'patients with chronic, bothersome tinnitus']",[],"['tinnitus loudness, tinnitus annoyance, and acceptability of the background sounds using a numeric 0-100 interval scale and completed the Tinnitus Primary Functions Questionnaire (TPFQ']","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",[],"[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0222045'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",18.0,0.0900412,"On the total score of the TPFQ, 5 of 15 remaining participants (33%) showed a benefit.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Tyler', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Perreau', 'Affiliation': 'Department of Communication Sciences and Disorders, Augustana College, Rock Island, IL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powers', 'Affiliation': 'Sivantos, Inc., Piscataway, NJ.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Watts', 'Affiliation': 'Department of Communication Sciences and Disorders, Augustana College, Rock Island, IL.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Ji', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Mancini', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18027']
268,30403956,The Effects of Extended Input Dynamic Range on Laboratory and Field-Trial Evaluations in Adult Hearing Aid Users.,"BACKGROUND


Digital hearing aids using a 16-bit analog-to-digital converter (ADC) provide a 96-dB input dynamic range. The level at which the ADC peak clips and distorts input signals ranges between 95 and 105 dB SPL. Recent research evaluated the effect of extending the input dynamic range in a commercially available hearing aid. Although the results were promising, several limitations were noted by the authors. Laboratory testing was conducted using recordings from hearing aids set for a flat 50-dB loss; however, field testing was conducted with hearing aids fitted for their hearing loss. In addition, participants rarely encountered input levels of sufficient intensity to adequately test the feature and were unable to directly compare aids with and without extended input dynamic range (EIDR) under identical conditions.
PURPOSE


The effects of EIDR under realistic and repeatable test conditions both within and outside the laboratory setting were evaluated.
RESEARCH DESIGN


A repeated measures design was used. The experiment was single-blinded.
STUDY SAMPLE


Twenty adults (14 males and six females) between the ages of 30 and 71 years (average age 62 years) who were experienced hearing aid users participated.
DATA COLLECTION AND ANALYSIS


Each participant was fit with Oticon Opn hearing instruments binaurally using the National Acoustics Laboratory-Nonlinear 1 fitting strategy. Participants completed a two-week trial period using hearing aids with EIDR and a two-week trial period without EIDR. The initial EIDR condition trial period was counterbalanced. After each trial, laboratory evaluations were obtained at 85 dBC using the Connected Speech Test, the Hearing in Noise Test, and the acceptable noise level (ANL). Satisfaction ratings were conducted at 85 dBC using speech in quiet and in noise as well as music. Field-trial evaluations were obtained using the abbreviated profile of hearing aid benefit (APHAB). Satisfaction ratings were also conducted in the field at 85 dBC using speech and music. After the study, each participant indicated which trial period they preferred overall. Repeated measures analysis of variances were conducted to assess listener performance. Pairwise comparisons were then completed for significant main effects.
RESULTS


In the laboratory, results did not reveal significant differences between EIDR conditions on any speech perception in noise test or any satisfaction rating measurement. In the field, results did not reveal significant differences between the EIDR conditions on the APHAB or on any of the satisfaction rating measurements. Nine participants (45%) preferred the EIDR condition. Fifteen participants (75%) indicated that speech clarity was the most important factor in determining the overall preference. Sixteen participants (80%) preferred the EIDR condition that resulted in the lower ANL.
CONCLUSIONS


The use of EIDR in hearing aids within and outside the laboratory under realistic and repeatable test conditions did not positively or negatively impact performance or preference. Results disagreed with previous findings obtained in the laboratory that suggested EIDR improved performance; however, results agreed with previous findings obtained in the field. Future research may consider the effect of hearing aid experience, input level, and noise acceptance on potential benefit with EIDR.",2019,"In the laboratory, results did not reveal significant differences between EIDR conditions on any speech perception in noise test or any satisfaction rating measurement.","['Adult Hearing Aid Users', 'Twenty adults (14 males and six females) between the ages of 30 and 71 years (average age 62 years) who were experienced hearing aid users participated']","['hearing aids with EIDR', 'Extended Input Dynamic Range']","['acceptable noise level (ANL', 'performance', 'speech clarity', 'listener performance', 'Satisfaction ratings', 'speech perception in noise test or any satisfaction rating measurement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid wearer'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0624017', 'cui_str': 'ANLS'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",20.0,0.0451336,"In the laboratory, results did not reveal significant differences between EIDR conditions on any speech perception in noise test or any satisfaction rating measurement.","[{'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Plyler', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Easterday', 'Affiliation': 'Department of Audiology and Speech Pathology, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Behrens', 'Affiliation': 'Centre for Applied Audiology Research, Oticon, Copenhagen, Denmark.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18003']
269,30349139,Effect of monosodium L-glutamate (umami substance) on cognitive function in people with dementia.,"BACKGROUND/OBJECTIVES


This study assessed the effect of continuous ingestion of monosodium L-glutamate (MSG) on cognitive function and dietary score in dementia patients.
SUBJECTS/METHODS


This was a single-blind, placebo-controlled trial involving 159 subjects with dementia residing in a hospital or nursing home. We assigned the subjects to a group that ingested MSG thrice daily (0.9 g/dose) (MSG group; n = 79) or a group that ingested NaCl thrice daily (0.26 g/dose) (Control group; n = 80). This study consisted of a 12-week intake period, followed by a 4-week follow-up period without the ingestion of MSG or NaCl. We performed physical examination, cognitive symptom tests (the Touch Panel-type Dementia Assessment Scale (TDAS) and Gottfries-Bråne-Steen Scale (GBSS)), palatability and behaviour questionnaires, and blood tests before and after the intervention and after the follow-up period.
RESULTS


There were no significant differences in the TDAS and GBSS total scores between the groups before and after the intervention. However, regarding the TDAS sub-items, ""the accuracy of the order of a process"" did not deteriorate in the MSG group compared with that observed in the Control group (p < 0.05). At the follow-up assessment, the TDAS total scores in the MSG group showed significant improvement compared with those reported in the Control group (p < 0.05). Furthermore, there was a correlation of changes from pre-intervention to post-intervention between the TDAS and enjoyment of the meal (r = -0.299, p = 0.049).
CONCLUSIONS


Our results suggest that continued ingestion of MSG has an effect on cognitive function. Furthermore, the patients with improved questionnaires about palatability survey showed greater improvement in cognitive function.",2019,There were no significant differences in the TDAS and GBSS total scores between the groups before and after the intervention.,"['people with dementia', '159 subjects with dementia residing in a hospital or nursing home', 'dementia patients']","['continuous ingestion of monosodium L-glutamate (MSG', 'placebo', 'MSG or NaCl', 'MSG', 'monosodium L-glutamate (umami substance', 'ingested MSG thrice daily (0.9\u2009g/dose) (MSG group; n\u2009=\u200979) or a group that ingested NaCl thrice daily']","['cognitive function', 'TDAS and GBSS total scores', 'TDAS total scores', 'physical examination, cognitive symptom tests (the Touch Panel-type Dementia Assessment Scale (TDAS) and Gottfries-Bråne-Steen Scale (GBSS)), palatability and behaviour questionnaires, and blood tests', 'cognitive function and dietary score']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0038180', 'cui_str': 'Granule-Bound Starch Synthase'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}]",159.0,0.0303465,There were no significant differences in the TDAS and GBSS total scores between the groups before and after the intervention.,"[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kouzuki', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan. kouzuki@med.tottori-u.ac.jp.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'Work Life Balance Support Center, Tottori University Hospital, 36-1 Nishicho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Nagano', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Syouta', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Katsumata', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Frontier Research Laboratories, Institute for Innovation, Ajinomoto Co., Inc., 1-1, Suzuki-Cho, Kawasaki-Ku, Kawasaki-Shi, 210-8681, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Urakami', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago, 683-8503, Japan.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0349-x']
270,30353121,Efficacy of L-carnitine supplementation for improving lean body mass and physical function in patients on hemodialysis: a randomized controlled trial.,"BACKGROUND


Carnitine deficiency is common in patients on hemodialysis. However, the efficacy of L-carnitine supplementation for improving lean body mass (LBM) and physical function has not yet been evaluated.
METHODS


In this multicenter, prospective, parallel, randomized, controlled trial, 91 patients on hemodialysis who developed carnitine deficiency were randomly assigned to receive injections of 1,000 mg L-carnitine 3 times per week after each hemodialysis session (L-carnitine group) or no injections (control group) with monitoring for 12 months.
RESULTS


The data for 84 of the 91 patients were available for analysis (L-carnitine group, n = 42; control group, n = 42). Dry weight and body mass index did not significantly change in the L-carnitine group, but significantly decreased in the control group. Arm muscle area (AMA) did not change significantly in the L-carnitine group but decreased significantly in the control group; the difference in mean AMA between the groups was 6.22% (95% confidence interval [CI] 1.90-10.5; P = 0.037). Hand grip strength did not change significantly in the L-carnitine group, but decreased significantly in the control group. The difference in change in hand grip strength between the groups was 4.27% (95% CI 0.42-8.12; P = 0.030). Furthermore, LBM did not change significantly in the L-carnitine group but decreased significantly in the control group; the difference in mean LBM between the groups was 2.92 % (95% CI 1.28-4.61; P = 0.0007).
CONCLUSIONS


L-carnitine supplementation is useful in patients who develop carnitine deficiency on hemodialysis because it maintains physical function and LBM.",2019,"Hand grip strength did not change significantly in the L-carnitine group, but decreased significantly in the control group.","['patients who develop carnitine deficiency on hemodialysis', '91 patients on hemodialysis who developed carnitine deficiency', 'patients on hemodialysis']","['L-carnitine supplementation', 'injections of 1,000 mg L-carnitine 3 times per week after each hemodialysis session (L-carnitine group) or no injections (control group) with monitoring for 12 months']","['lean body mass and physical function', 'mean LBM', 'Arm muscle area (AMA', 'lean body mass (LBM) and physical function', 'change in hand grip strength', 'Hand grip strength', 'Dry weight and body mass index', 'mean AMA', 'LBM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1142132', 'cui_str': 'Carnitine deficiency (disorder)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",91.0,0.0307208,"Hand grip strength did not change significantly in the L-carnitine group, but decreased significantly in the control group.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Maruyama', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nephrology, Keiai Hospital, Tokyo, Japan.'}, {'ForeName': 'Chinami', 'Initials': 'C', 'LastName': 'Nagura', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kitai', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Utsunomiya', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ritsukou', 'Initials': 'R', 'LastName': 'Tei', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Furukawa', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Nephrology, Keiai Hospital, Tokyo, Japan.'}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Okawa', 'Affiliation': 'Department of Nephrology, Keiai Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Keiai Hospital, Tokyo, Japan.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Nephrology, Meirikai Chuo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. abe.masanori@nihon-u.ac.jp.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0348-y']
271,32323609,"Phase I/II Study of Intrathecal Administration of Recombinant Human Hepatocyte Growth Factor in Patients with Acute Spinal Cord Injury: A Double-Blind, Randomized Clinical Trial of Safety and Efficacy.","Spinal cord injury (SCI) is an abrupt traumatic injury that leads to permanent functional loss, and no practical treatment is available. We have developed pharmaceutical recombinant human hepatocyte growth factor (KP-100), and its efficacy for SCI has been verified using animal models. The purpose of this study was to evaluate the safety and efficacy of intrathecal KP-100 administration for SCI patients in the acute phase. This investigation was a multi-center, randomized, double-blind study. Subjects with modified Frankel grade A/B1/B2 at 72 h after SCI were included. KP-100 was administered intrathecally. Subjects were followed up for 168 days after the first administration. Outcomes were evaluated using American Spinal Injury Association (ASIA) scores and subjected to analysis of covariance. Our results demonstrated that the subjects did not show any serious adverse events caused by KP-100. Forty-three subjects underwent neurological function testing (26 in KP-100 group; 17 in placebo group), which revealed that KP-100 contributed to motor improvement at Days 140 ( p  = 0.050) and 168 ( p  = 0.079). In the subset of subjects with Frankel grade A, the proportions of subjects who gained at least 1 point on their lower-extremity motor scores were 33.3% (5/15) and 6.3% (1/16) in the KP-100 and placebo groups, respectively ( p  = 0.083). Therefore, KP-100 has the potential to be useful and beneficial for SCI patients during the acute phase. However, this was a phase I/II trial and did not definitely address the question of efficacy; a larger phase III trial would be required to assess the efficacy.",2020,Our results demonstrated that the subjects did not show any serious adverse events caused by KP-100.,"['Subjects with modified Frankel grade', 'SCI patients in the acute phase', 'patients with acute spinal cord injury']","['KP-100', 'intrathecal KP-100', 'recombinant human hepatocyte growth factor', 'placebo']","['American Spinal Injury Association (ASIA) scores', 'neurological function testing', 'lower-extremity motor scores', 'safety and efficacy']","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C1447107', 'cui_str': 'HGF protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.111947,Our results demonstrated that the subjects did not show any serious adverse events caused by KP-100.,"[{'ForeName': 'Narihito', 'Initials': 'N', 'LastName': 'Nagoshi', 'Affiliation': 'Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osahiko', 'Initials': 'O', 'LastName': 'Tsuji', 'Affiliation': 'Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'Department of Orthopedic Surgery, Saiseikai Yokohama-shi Tobu Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Suda', 'Affiliation': 'Department of Orthopedic Surgery, Hokkaido Spinal Cord Injury Center, Hokkaido, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Orthopedic Surgery, Spinal Injuries Center, Fukuoka, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Yato', 'Affiliation': 'Department of Orthopedic Surgery, Murayama Medical Center, National Hospital Organization, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Faculty of Data Science, Yokohama City University School of Data Science, Kanagawaken, Japan.'}, {'ForeName': 'Daichika', 'Initials': 'D', 'LastName': 'Hayata', 'Affiliation': 'Kringle Pharma, Inc., Osaka, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Okano', 'Affiliation': 'Department of Physiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Journal of neurotrauma,['10.1089/neu.2019.6854']
272,32323640,Does Home-Based Exercise Improve the Physical Function of Prefrail Older Women?,"Physical exercise is a potential intervention to revert or attenuate frailty syndrome, which may be accomplished by traditional center-based and home-based programs. This study aimed to compare the effectiveness of a home-based and center-based exercise program on frailty status, physical and muscle function of frail older women. Thirty-one frail older women were allocated in two different groups: home-based group ( n  = 17, 71.5 ± 6.5 years) or center-based group ( n  = 14, 68.4 ± 6.4 years). The exercise program lasted 12 weeks (3 days/week), 60 minutes/session, including strengthening, balance, and gait exercises. Frailty status, knee, and hip strength, and physical function were assessed before and after the intervention. After the exercise program, frailty was reversed in 76% of the participants independently of the exercise group. Muscle strength and physical function improved in both groups, where the home-based program presented a high adherence rate, and the center-based program was more suitable to reverse the frailty status. In conclusion, a home-based exercise program is as effective as center based to improve strength, physical function, and to reverse frailty status.",2020,"Muscle strength and physical function improved in both groups, where the Home-Based program presented a high adherence rate, and the Center-Based program was more suitable to reverse the frailty status.
","['Thirty-one', 'frail older women', 'frailty older women', 'pre-frail older women']","['Physical exercise', 'home-based and center-based exercise program']","['frailty status, physical and muscle function', 'Frailty status, knee, and hip strength, and physical function', 'Muscle strength and physical function']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",31.0,0.0230119,"Muscle strength and physical function improved in both groups, where the Home-Based program presented a high adherence rate, and the Center-Based program was more suitable to reverse the frailty status.
","[{'ForeName': 'Ryelen N Santos de Abreu', 'Initials': 'RNSA', 'LastName': 'Garcia', 'Affiliation': 'Physical Education Department, Federal University of Paraná (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Sabrine N', 'Initials': 'SN', 'LastName': 'Costa', 'Affiliation': 'Physical Education Department, Federal University of Paraná (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Erick D Santos de Abreu', 'Initials': 'EDSA', 'LastName': 'Garcia', 'Affiliation': 'Physical Education Department, Federal University of Paraná (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Paulo Cesar Barauce', 'Initials': 'PCB', 'LastName': 'Bento', 'Affiliation': 'Physical Education Department, Federal University of Paraná (UFPR), Curitiba, Brazil.'}]",Rejuvenation research,['10.1089/rej.2019.2292']
273,31320277,Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.,"BACKGROUND


Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo.
METHODS


In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565.
FINDINGS


Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change -1·5 points, 95% CI -3·4 to 0·4, p=0·12), biofeedback versus education (-0·7 points, -2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (-1·9 points, -4·1 to 0·3, p=0·092) or versus loperamide plus education (-1·1 points, -3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
INTERPRETATION


In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health.",2019,"Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
","['Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300', 'Women with at least one episode of faecal incontinence per month in the past 3 months', 'participants were recruited from eight clinical sites in the USA', 'women by performing']","['placebo plus education', 'anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo', 'placebo', 'standardised faecal incontinence patient education pamphlet', 'loperamide or oral placebo', 'strength and sensory biofeedback training', 'anal exercises with biofeedback or loperamide', 'placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback', 'oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback']","['Constipation', ""change in St Mark's (Vaizey) faecal incontinence severity score"", 'percentage of participants with any serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",377.0,0.529028,"Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
","[{'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': ""Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA. Electronic address: eric.jelovsek@duke.edu.""}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Birmingham, AL, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Whitehead', 'Affiliation': 'Department of Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Barber', 'Affiliation': ""Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Division of Urology, Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA; Department of Women's Health, Dell Medical School, University of Texas at Austin, Austin, TX, USA.""}, {'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Sutkin', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA, USA; Department of Obstetrics and Gynecology, University of Missouri, Kansas City, MO, USA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Meikle', 'Affiliation': 'Northwest Texas Physician Group, Amarillo, TX, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30193-1']
274,32229466,The Effect of Narrative on Physical Activity via Immersion During Active Video Game Play in Children: Mediation Analysis.,"BACKGROUND


Active video games (AVGs) can increase physical activity (PA) and help produce higher physiological expenditure. Animated narrative videos (NVs) possess unique immersive and motivational properties. When added to AVGs, they have been found to increase moderate-to-vigorous physical activity (MVPA) as opposed to the original no video condition. However, there is no evidence of whether that was due to the NV or the addition of an animated video to an AVG.
OBJECTIVE


This study aimed to investigate the differential effect of adding an NV versus a nonnarrative video (NNV) to an AVG on PA parameters and physiological responses and to explore the mediating role of immersion.
METHODS


A total of 22 children aged 8 to 12 years were randomly assigned to the NV or NNV condition. They were instructed to play an AVG (on Xbox Kinect) for as long as they wanted. We used accelerometers to estimate the time spent (in minutes) in MVPA. Heart rate (HR) and rate of perceived exertion (RPE) were measured before, during, and after the AVG play session. The participants then reported their experience of narrative immersion via a questionnaire.
RESULTS


The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 20.11, SD 13.75 vs mean 7.85, SD 5.83; P=.02). Narrative immersion was positively correlated with MVPA (r=0.52; P=.01) and average HR during AVG (r=0.43; P=.05). Mediation analysis indicated that narrative immersion mediated the effect of NV (NV vs NNV) on MVPA (direct effect: beta=7.51; P=.01). The indirect effect was that NV was positively correlated with the mediator variable narrative immersion (beta=.59; P=.03), which was itself marginally associated with MVPA (beta=6.95; P=.09); when narrative immersion was included in the model, the regression coefficient was attenuated.
CONCLUSIONS


AVG with added narratives elicits more narrative immersion, resulting in more minutes in MVPA. Narrative immersion served as a mediator between NV and MVPA via its elicitation of an elevated HR without increasing RPE. The inclusion of immersive narratives in AVG could be helpful for inducing MVPA, to enhance AVG engagement without additional exertion.",2020,"The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 20.11, SD 13.75 vs mean 7.85, SD 5.83; P=.02).","['22 children aged 8 to 12 years', 'Children']","['Narrative on Physical Activity via Immersion', 'Active video games (AVGs', 'NV versus a nonnarrative video (NNV', 'Animated narrative videos (NVs) possess unique immersive and motivational properties']","['MVPA', 'Narrative immersion', 'narrative immersion', 'Heart rate (HR) and rate of perceived exertion (RPE', 'physical activity (PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]","[{'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",22.0,0.0859879,"The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 20.11, SD 13.75 vs mean 7.85, SD 5.83; P=.02).","[{'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Stanford University Medical Center, Department of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Amy Shirong', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}]",Journal of medical Internet research,['10.2196/17994']
275,29309023,A Randomized Controlled Trial to Evaluate Approaches to Auditory Rehabilitation for Blast-Exposed Veterans with Normal or Near-Normal Hearing Who Report Hearing Problems in Difficult Listening Situations.,"BACKGROUND


Blast exposure is a major source of injury among Service members in the Iraq and Afghanistan conflicts. Many of these blast-exposed veterans report hearing-related problems such as difficulties understanding speech in noise and rapid speech, and following instructions and long conversations that are disproportionate to their measured peripheral hearing sensitivity. Evidence is mounting that these complaints result from damage to the central auditory processing system.
PURPOSE


To evaluate the effectiveness of audiological rehabilitative interventions for blast-exposed veterans with normal or near-normal peripheral hearing and functional hearing difficulties.
RESEARCH DESIGN


A randomized controlled trial with four intervention arms.
STUDY SAMPLE


Ninety-nine blast-exposed veterans with normal or near-normal peripheral hearing who reported functional hearing difficulties.
INTERVENTION


Four interventions were compared: compensatory communication strategies (CCS) education, CCS and use of a personal frequency modulation system (FM + CCS), CCS and use of an auditory training program (AT + CCS), and use of all three interventions combined (FM + AT + CCS).
DATA COLLECTION AND ANALYSIS


All participants tested before, and immediately following an 8-week intervention period. The primary outcome measures upon which the study was powered assessed speech understanding in noise and self-reported psychosocial impacts of the intervention. In addition, auditory temporal processing, auditory working memory, allocation of attention, and hearing and cognitive self-report outcomes were assessed.
RESULTS


Use of FM + CCS resulted in significant benefit for speech understanding in noise and self-reported hearing benefits, and FM + AT + CCS provided more self-reported cognitive benefits than FM + CCS, AT + CCS, or CCS. Further, individuals liked and reported using the FM system, but there was poor adherence to and high attrition among individuals assigned to receive AT.
CONCLUSIONS


It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.",2018,It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.,"['Blast-Exposed Veterans with Normal or Near-Normal Hearing', 'blast-exposed veterans with normal or near-normal peripheral hearing and functional hearing difficulties', 'SAMPLE\n\n\nNinety-nine blast-exposed veterans with normal or near-normal peripheral hearing who reported functional hearing difficulties']","['audiological rehabilitative interventions', 'FM + CCS', 'FM system (or remote microphone via Bluetooth system', 'compensatory communication strategies (CCS) education, CCS and use of a personal frequency modulation system (FM + CCS), CCS and use of an auditory training program (AT + CCS), and use of all three interventions combined (FM + AT + CCS', 'Auditory Rehabilitation', 'FM + CCS, AT + CCS, or CCS']","['auditory temporal processing, auditory working memory, allocation of attention, and hearing and cognitive self-report outcomes', 'speech understanding in noise and self-reported psychosocial impacts of the intervention']","[{'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0200323', 'cui_str': 'Auditory rehabilitation'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",99.0,0.0735701,It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.,"[{'ForeName': 'Gabrielle H', 'Initials': 'GH', 'LastName': 'Saunders', 'Affiliation': 'National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': 'Frederick', 'Affiliation': 'National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Arnold', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Florida, Tampa, FL.'}, {'ForeName': 'ShienPei C', 'Initials': 'SC', 'LastName': 'Silverman', 'Affiliation': 'National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR.'}, {'ForeName': 'Theresa H', 'Initials': 'TH', 'LastName': 'Chisolm', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Florida, Tampa, FL.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Myers', 'Affiliation': ""James A. Haley Veterans' Hospital, Tampa, FL.""}]",Journal of the American Academy of Audiology,['10.3766/jaaa.16143']
276,29488872,Test-Retest Reliability and Minimal Detectable Change of Randomized Dichotic Digits in Learning-Disabled Children: Implications for Dichotic Listening Training.,"BACKGROUND


Evaluation of dichotic listening to digits is a common part of many studies for diagnosis and managing auditory processing disorders in children. Previous researchers have verified test-retest relative reliability of dichotic digits results in normal children and adults. However, detecting intervention-related changes in the ear scores after dichotic listening training requires information regarding trial-to-trial typical variation of individual ear scores that is estimated using indices of absolute reliability. Previous studies have not addressed absolute reliability of dichotic listening results.
PURPOSE


To compare the results of the Persian randomized dichotic digits test (PRDDT) and its relative and absolute indices of reliability between typical achieving (TA) and learning-disabled (LD) children.
RESEARCH DESIGN


A repeated measures observational study.
STUDY SAMPLE


Fifteen LD children were recruited from a previously performed study with age range of 7-12 yr. The control group consisted of 15 TA schoolchildren with age range of 8-11 yr.
DATA COLLECTION AND ANALYSIS


The Persian randomized dichotic digits test was administered on the children under free recall condition in two test sessions 7-12 days apart. We compared the average of the ear scores and ear advantage between TA and LD children. Relative indices of reliability included Pearson's correlation and intraclass correlation (ICC 2,1 ) coefficients and absolute reliability was evaluated by calculation of standard error of measurement (SEM) and minimal detectable change (MDC) using the raw ear scores.
RESULTS


The Pearson correlation coefficient indicated that in both groups of children the ear scores of test and retest sessions were strongly and positively (greater than +0.8) correlated. The ear scores showed excellent ICC coefficient of consistency (0.78-0.82) and fair to excellent ICC coefficient of absolute agreement (0.62-0.74) in TA children and excellent ICC coefficients of consistency and absolute agreement in LD children (0.76-0.87). SEM and SEM% of the ear scores in TA children were 1.46 and 1.44% for the right ear and 4.68 and 5.47% for the left ear. SEM and SEM% of the ear scores in LD children were 4.55 and 5.88% for the right ear to 7.56 and 12.81% for the left ear. MDC and MDC% of the ear scores in TA children varied from 4.03 and 3.99% for the right ear to 12.93 and 15.13% for the left ear. MDC and MDC% of the ear scores in LD children varied from 12.57 and 16.25% for the right ear to 20.89 and 35.39% for the left ear.
CONCLUSIONS


The LD children indicated test-retest relative reliability as high as TA children in the ear scores measured by PRDDT. However, within-subject variations of the ear scores calculated by indices of absolute reliability were considerably higher in LD children versus TA children. The results of the current study could have implications for detecting real training-related changes in the ear scores.",2018,The LD children indicated test-retest relative reliability as high as TA children in the ear scores measured by PRDDT.,"['children', '15 TA schoolchildren with age range of 8-11 yr', 'Fifteen LD children were recruited from a previously performed study with age range of 7-12 yr', 'normal children and adults', 'Learning-Disabled Children']","['Persian randomized dichotic digits test (PRDDT', 'Dichotic Listening Training', 'dichotic listening training']","['MDC and MDC% of the ear scores', 'standard error of measurement (SEM) and minimal detectable change (MDC) using the raw ear scores', 'SEM and SEM% of the ear scores', 'ICC coefficient of consistency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0259916', 'cui_str': 'Children with Disabilities'}]","[{'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",15.0,0.0238719,The LD children indicated test-retest relative reliability as high as TA children in the ear scores measured by PRDDT.,"[{'ForeName': 'Mohammad Ebrahim', 'Initials': 'ME', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Pourbakht', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Parand', 'Affiliation': 'Faculty of Psychology and Education, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Jalaie', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.16134']
277,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES


Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested.
PARTICIPANTS/METHODS


Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age.
RESULTS


RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
CONCLUSIONS


Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1']
278,29664721,Effect of Adaptive Compression and Fast-Acting WDRC Strategies on Sentence Recognition in Noise in Mandarin-Speaking Pediatric Hearing Aid Users.,"BACKGROUND


Wide dynamic range compression (WDRC) has been widely used in hearing aid technology. However, several reports indicate that WDRC may improve audibility at the expense of speech intelligibility. As such, a modified amplification compression scheme, named adaptive compression, was developed. However, the effect of compression strategies on speech perception in pediatric hearing aid users has not been clearly reported.
PURPOSE


The purpose of the present study was to investigate the effect of adaptive compression and fast-acting WDRC processing strategies on sentence recognition in noise with Mandarin, pediatric hearing aid users.
RESEARCH DESIGN


This study was set up using a double-blind, within-subject, repeated-measures design.
STUDY SAMPLE


Twenty-six children who spoke Mandarin Chinese as their primary language and had bilateral sensorineural hearing loss participated in the study.
DATA COLLECTION AND ANALYSIS


Sentence recognition in noise was evaluated in behind-the-ear technology with both adaptive compression processing and fast-acting WDRC processing and was selected randomly for each child. Percent correct sentence recognition in noise with fast-acting WDRC and adaptive compression was collected from each participant. Correlation analysis was performed to examine the effect of gender, age at assessment, and hearing threshold of the better ear on signal-to-noise ratio, and a paired-samples t test was employed to compare the performance of the adaptive compression strategy and fast-acting WDRC processing.
RESULTS


The mean percentage correct of sentence recognition in noise with behind-the-ear technology with fast-acting WDRC and adaptive compression processing were 62.24% and 68.71%, respectively. The paired-samples t test showed that the performance of the adaptive compression strategy was significantly better than the fast-acting WDRC processing (t = 3.190, p = 0.004).
CONCLUSIONS


Compared with the fast-acting WDRC, adaptive compression provided better sentence recognition in noise for Mandarin pediatric hearing aid users.",2018,"Compared with the fast-acting WDRC, adaptive compression provided better sentence recognition in noise for Mandarin pediatric hearing aid users.","['Sentence Recognition in Noise in Mandarin-Speaking Pediatric Hearing Aid Users', 'pediatric hearing aid users', 'SAMPLE\n\n\nTwenty-six children who spoke Mandarin Chinese as their primary language and had bilateral sensorineural hearing loss participated in the study', 'Mandarin pediatric hearing aid users', 'noise with Mandarin, pediatric hearing aid users']","['WDRC', 'Adaptive Compression and Fast-Acting WDRC Strategies', 'fast-acting WDRC, adaptive compression', 'compression strategies', 'adaptive compression and fast-acting WDRC processing strategies', 'Wide dynamic range compression (WDRC']","['speech perception', 'mean percentage correct of sentence recognition in noise with behind-the-ear technology with fast-acting WDRC and adaptive compression processing']","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0452138', 'cui_str': 'Sensorineural hearing loss, bilateral (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]",26.0,0.0245038,"Compared with the fast-acting WDRC, adaptive compression provided better sentence recognition in noise for Mandarin pediatric hearing aid users.","[{'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Yuanhu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Wentong', 'Initials': 'W', 'LastName': 'Ge', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': ""Beijing Key Laboratory for Pediatric Otolaryngology, Head and Neck Science, Department of Otolaryngology Head and Neck Surgery, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}]",Journal of the American Academy of Audiology,['10.3766/jaaa.16086']
279,31859682,Clinically Meaningful Use of Mental Health Apps and its Effects on Depression: Mixed Methods Study.,"BACKGROUND


User engagement is key to the effectiveness of digital mental health interventions. Considerable research has examined the clinical outcomes of overall engagement with mental health apps (eg, frequency and duration of app use). However, few studies have examined how specific app use behaviors can drive change in outcomes. Understanding the clinical outcomes of more nuanced app use could inform the design of mental health apps that are more clinically effective to users.
OBJECTIVE


This study aimed to classify user behaviors in a suite of mental health apps and examine how different types of app use are related to depression and anxiety outcomes. We also compare the clinical outcomes of specific types of app use with those of generic app use (ie, intensity and duration of app use) to understand what aspects of app use may drive symptom improvement.
METHODS


We conducted a secondary analysis of system use data from an 8-week randomized trial of a suite of 13 mental health apps. We categorized app use behaviors through a mixed methods analysis combining qualitative content analysis and principal component analysis. Regression analyses were used to assess the association between app use and levels of depression and anxiety at the end of treatment.
RESULTS


A total of 3 distinct clusters of app use behaviors were identified: learning, goal setting, and self-tracking. Each specific behavior had varied effects on outcomes. Participants who engaged in self-tracking experienced reduced depression symptoms, and those who engaged with learning and goal setting at a moderate level (ie, not too much or not too little) also had an improvement in depression. Notably, the combination of these 3 types of behaviors, what we termed ""clinically meaningful use,"" accounted for roughly the same amount of variance as explained by the overall intensity of app use (ie, total number of app use sessions). This suggests that our categorization of app use behaviors succeeded in capturing app use associated with better outcomes. However, anxiety outcomes were neither associated with specific behaviors nor generic app use.
CONCLUSIONS


This study presents the first granular examination of user interactions with mental health apps and their effects on mental health outcomes. It has important implications for the design of mobile health interventions that aim to achieve greater user engagement and improved clinical efficacy.",2019,"However, anxiety outcomes were neither associated with specific behaviors nor generic app use.
","['13 mental health apps', 'Participants who engaged in self-tracking experienced reduced depression symptoms, and those who engaged with learning and goal setting at a moderate level (ie, not too much or not too little) also had an improvement in depression']",[],['anxiety outcomes'],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",13.0,0.0746312,"However, anxiety outcomes were neither associated with specific behaviors nor generic app use.
","[{'ForeName': 'Renwen', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Communication Studies, Northwestern University, Evanston, IL, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Knapp', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Department of Communication Studies, Northwestern University, Evanston, IL, United States.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}]",Journal of medical Internet research,['10.2196/15644']
280,30127374,Effect of flaxseed consumption on flow-mediated dilation and inflammatory biomarkers in patients with coronary artery disease: a randomized controlled trial.,"BACKGROUND/OBJECTIVE


Available data indicate a possible beneficial effect of flaxseed on cardiovascular disease, but limited studies have evaluated the effects of flaxseed on endothelial dysfunction and biomarkers of inflammation in patients with coronary artery disease (CAD). The purpose of the present study was to examine the effect of flaxseed consumption on flow-mediated dilation (FMD) and inflammatory markers in CAD patients.
SUBJECTS/METHOD


In this randomized controlled parallel trial, 50 patients with CAD of both genders were randomly allocated to 12 weeks consumption of flaxseed (30 g/day) or usual care control. Before and after the intervention, changes in brachial FMD and plasma high-sensitivity C-reactive protein (hs-CRP), interleukine-6 (IL-6), and tumor necrosis factor-α (TNF-α) were measured.
RESULTS


Forty-four participants (aged 56.43 ± 8.21 years; BMI 26.65 ± 2.44 kg/m 2 ) completed the study. No significant weight change was observed in either group. Compared to control (n = 23), flaxseed consumption (n = 21) was associated with improved FMD (mean of change from baseline was 5.1 vs -0.55%; p = 0.001 for the flaxseed and control, respectively). When compared to control, flaxseed consumption was associated with reduced inflammatory markers (mean of change from baseline for hs-CRP was -1.18 and -0.3 mg/L, p = 0.003; for IL-6 was -7.65 and -0.77 pg/mL, p = 0.017; for TNF-α was -34.73 and -2.18 pg/mL p = 0.001 in flaxseed and control, respectively).
CONCLUSIONS


The results of this study indicate that by adding flaxseed to diet of CAD patients, it is possible to improve FMD and plasma levels of inflammatory markers.",2019,"Compared to control (n = 23), flaxseed consumption (n = 21) was associated with improved FMD (mean of change from baseline was 5.1 vs -0.55%; p = 0.001 for the flaxseed and control, respectively).","['CAD patients', 'patients with coronary artery disease (CAD', 'patients with coronary artery disease', 'Forty-four participants (aged 56.43\u2009±\u20098.21 years; BMI 26.65\u2009±\u20092.44\u2009kg/m 2 ) completed the study', '50 patients with CAD of both genders']","['consumption of flaxseed (30\u2009g/day) or usual care control', 'flaxseed consumption']","['flow-mediated dilation and inflammatory biomarkers', 'FMD', 'FMD and plasma levels of inflammatory markers', 'flow-mediated dilation (FMD) and inflammatory markers', 'IL-6', 'inflammatory markers', 'flaxseed consumption', 'weight change', 'brachial FMD and plasma high-sensitivity C-reactive protein (hs-CRP), interleukine-6 (IL-6), and tumor necrosis factor-α (TNF-α']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023753', 'cui_str': 'Flaxseed'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023753', 'cui_str': 'Flaxseed'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",50.0,0.287578,"Compared to control (n = 23), flaxseed consumption (n = 21) was associated with improved FMD (mean of change from baseline was 5.1 vs -0.55%; p = 0.001 for the flaxseed and control, respectively).","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Khandouzi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Shahid Rajaei Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadzadeh', 'Affiliation': 'Shadid Rajaei Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Sanati', 'Affiliation': 'Cardiovascular Intervention Research Center, Shahid Rajaei Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. jnasrollahzadeh@gmail.com.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0268-x']
281,31923105,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2020,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
282,30884679,"Eight-week hempseed oil intervention improves the fatty acid composition of erythrocyte phospholipids and the omega-3 index, but does not affect the lipid profile in children and adolescents with primary hyperlipidemia.","Children affected by primary hyperlipidemia have a high risk of developing cardiovascular diseases (CVDs) during adulthood. Several studies have reported a positive association between the intake of polyunsaturated fatty acids (PUFAs) and improvements in lipid markers and CVD risk. Dietary supplements may represent a potential strategy in the management of hyperlipidemia. In this context, the effectiveness of hempseed oil (HSO) rich in PUFAs (particularly linoleic acid (LA) and α-linolenic acid (ALA)) in the modulation of hyperlipidemia has been poorly investigated. The present pilot study aimed to explore the impact of HSO supplementation on the serum lipid profile and fatty acid (FA) composition of red blood cells (RBCs) in children and adolescents with primary hyperlipidemia. A randomized, 8 week long, parallel dietary intervention study was performed. Thirty-six hyperlipidemic probands (6-16 years) on diet therapy were randomized into two groups: the HSO group, receiving 3 g of HSO providing 1.4 g of LA and 0.7 g/day of ALA, and the control group. Both groups received specific dietary guidelines. Before and after the intervention, blood samples were collected and the serum lipid profile, FA composition of RBCs and omega-3-index were analyzed. Eight weeks of supplementation with HSO significantly (p < .01) reduced the RBC content of total saturated and monounsaturated FAs (-5.02 ± 7.94% and - 2.12 ± 2.23%, respectively), increased the levels of total n-3 and n-6 PUFAs (+1.57 ± 1.96% and + 5.39 ± 7.18%, respectively) and the omega-3 index (+1.18 ± 1.42%), but failed to affect the serum lipid profile compared to the control group. In conclusion, our findings seem to support the contribution of HSO supplementation in improving the RBC phospholipid composition and omega-3 index, while no effect was observed regarding modulation of the lipid profile. Further controlled studies are necessary to achieve a complete understanding of the effects of HSO in the modulation of hyperlipidemia and CVD risk in this and other target groups.",2019,"Eight weeks of supplementation with HSO significantly (p < .01) reduced the RBC content of total saturated and monounsaturated FAs (-5.02 ± 7.94% and - 2.12 ± 2.23%, respectively), increased the levels of total n-3 and n-6 PUFAs (+1.57 ± 1.96% and + 5.39 ± 7.18%, respectively) and the omega-3 index (+1.18 ± 1.42%), but failed to affect the serum lipid profile compared to the control group.","['children and adolescents with primary hyperlipidemia', 'Thirty-six hyperlipidemic probands (6-16\u202fyears) on']","['HSO supplementation', 'diet therapy', 'HSO', 'hempseed oil (HSO) rich in PUFAs (particularly linoleic acid (LA) and α-linolenic acid (ALA', 'HSO group, receiving 3\u202fg of HSO providing 1.4\u202fg of LA and 0.7\u202fg/day of ALA', 'oil intervention', 'specific dietary guidelines']","['RBC phospholipid composition and omega-3 index', 'fatty acid composition of erythrocyte phospholipids and the omega-3 index', 'lipid profile', 'serum lipid profile', 'serum lipid profile and fatty acid (FA) composition of red blood cells (RBCs', 'serum lipid profile, FA composition of RBCs and omega-3-index', 'RBC content of total saturated and monounsaturated FAs', 'levels of total n-3 and n-6 PUFAs', 'omega-3 index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0522534', 'cui_str': 'Saturated (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",36.0,0.0250483,"Eight weeks of supplementation with HSO significantly (p < .01) reduced the RBC content of total saturated and monounsaturated FAs (-5.02 ± 7.94% and - 2.12 ± 2.23%, respectively), increased the levels of total n-3 and n-6 PUFAs (+1.57 ± 1.96% and + 5.39 ± 7.18%, respectively) and the omega-3 index (+1.18 ± 1.42%), but failed to affect the serum lipid profile compared to the control group.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Deon', 'Affiliation': 'Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Abello', 'Affiliation': 'Department of Public Health and Pediatric Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Massini', 'Affiliation': 'Department of Public Health and Pediatric Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Porrini', 'Affiliation': 'Department of Public Health and Pediatric Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Guardamagna', 'Affiliation': 'Department of Public Health and Pediatric Sciences, Università degli Studi di Torino, Turin, Italy. Electronic address: ornella.guardamagna@unito.it.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2018.12.045']
283,30884705,Extruded sorghum consumption associated with a caloric restricted diet reduces body fat in overweight men: A randomized controlled trial.,"This study aimed to evaluate the effect of sorghum intake on body composition and metabolic variables in overweight men. In a randomized controlled crossover study, 24 overweight men (25.6 ± 4.6 years) were randomly allocated into one of two treatments: extruded sorghum or extruded wheat. The study consisted of 2 periods of 8 weeks with at least 4 weeks of washout. Anthropometric, clinical and metabolic risk variables were assessed at baseline and at the end of each intervention period. Extruded sorghum consumption reduced body fat percentage and increased daily carbohydrate and dietary fiber intake when compared to wheat consumption. Also, sorghum increased the serum glutathione peroxidase concentration, but no difference was observed when compared to wheat consumption. Extruded sorghum demonstrated to be a good alternative to control obesity in overweight men.",2019,Extruded sorghum consumption reduced body fat percentage and increased daily carbohydrate and dietary fiber intake when compared to wheat consumption.,"['24 overweight men (25.6\u202f±\u202f4.6\u202fyears', 'overweight men']","['extruded sorghum or extruded wheat', 'sorghum intake', 'caloric restricted diet']","['body fat percentage and increased daily carbohydrate and dietary fiber intake', 'Anthropometric, clinical and metabolic risk variables', 'serum glutathione peroxidase concentration', 'body composition and metabolic variables']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0331570', 'cui_str': 'Sorghum'}, {'cui': 'C0532245', 'cui_str': 'Extrude'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",24.0,0.0342867,Extruded sorghum consumption reduced body fat percentage and increased daily carbohydrate and dietary fiber intake when compared to wheat consumption.,"[{'ForeName': 'Pamella Cristine', 'Initials': 'PC', 'LastName': 'Anunciação', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil. Electronic address: nutripamella@gmail.com.'}, {'ForeName': 'Leandro de Morais', 'Initials': 'LM', 'LastName': 'Cardoso', 'Affiliation': 'Departamento de Nutrição, Universidade Federal de Juiz de Fora, Campus Governador Valadares, Governador Valadares, Minas Gerais, Brazil.'}, {'ForeName': 'Rita de Cássia Gonçalves', 'Initials': 'RCG', 'LastName': 'Alfenas', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Valéria Aparecida Vieira', 'Initials': 'VAV', 'LastName': 'Queiroz', 'Affiliation': 'EMBRAPA Milho e Sorgo, Sete Lagoas, Minas Gerais, Brazil.'}, {'ForeName': 'Carlos Wanderlei Piler', 'Initials': 'CWP', 'LastName': 'Carvalho', 'Affiliation': 'EMBRAPA Agroindústria de Alimentos, Rio de Janeiro, Brazil.'}, {'ForeName': 'Hércia Stampini Duarte', 'Initials': 'HSD', 'LastName': 'Martino', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Helena Maria', 'Initials': 'HM', 'LastName': ""Pinheiro-Sant'Ana"", 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2018.10.048']
284,32320533,First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.,"OBJECTIVE


Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.
METHODS


This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.
RESULTS


RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).
CONCLUSIONS


The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.",2020,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).",['adults with both conditions'],['integrated intervention'],"['Annual spending on medical care services', 'intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0723905,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22805']
285,32321651,Multifocal transcranial stimulation in chronic ischemic stroke: A phase 1/2a randomized trial.,"BACKGROUND AND PURPOSE


Repetitive transcranial magnetic stimulation (rTMS) may promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. The objective of this study was to examine whether multifocal cortical stimulation using a new wearable transcranial rotating permanent magnet stimulator (TRPMS) can promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits.
METHODS


Thirty 30  patients with chronic ischemic stroke and stable unilateral weakness were enrolled in a Phase 1/2a randomized double-blind sham-controlled clinical trial to evaluate safety and preliminary efficacy. Bilateral hemispheric stimulation was administered for 20 sessions 40 min each over 4 weeks. The primary efficacy endpoint was the change in functional MRI BOLD activation immediately after end of treatment. Secondary efficacy endpoints were clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS.
RESULTS


TRPMS treatment was well-tolerated with no device-related adverse effects. Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038). The median active voxel number after active treatment was 8.8-fold greater than after sham (227.5 vs 26, p = 0.016). Although the statistical power was inadequate to establish clinical endpoint benefits, numerical improvements were demonstrated in 5 of 6 clinical scales of motor function. The treatment effects persisted over a 3-month duration of follow-up.
CONCLUSIONS


Multifocal bilateral TRPMS was safe and showed significant fMRI changes suggestive of functional reorganization of cortical circuits in patients with chronic ischemic stroke. A larger randomized clinical trial is warranted to verify recovery of motor function.",2020,"Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038).","['chronic ischemic stroke', 'Thirty 30  patients with chronic ischemic stroke and stable unilateral weakness', 'patients with chronic ischemic stroke']","['Repetitive transcranial magnetic stimulation (rTMS', 'transcranial rotating permanent magnet stimulator (TRPMS', 'Multifocal transcranial stimulation', 'Bilateral hemispheric stimulation']","['change in functional MRI BOLD activation', 'number of active voxels on fMRI', 'clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS', 'tolerated with no device-related adverse effects', 'median active voxel number']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.4372,"Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chiu', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States. Electronic address: dchiu@houstonmethodist.org.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'McCane', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Blessy', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Gadhia', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Misra', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Volpi', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Santosh A', 'Initials': 'SA', 'LastName': 'Helekar', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104816']
286,32321718,Intratumoral Comparison of Nanoparticle Entrapped Docetaxel (CPC634) with Conventional Docetaxel in Patients with Solid Tumors.,"PURPOSE


CPC634 is a novel nanoparticle entrapping docetaxel, developed to enhance the intratumoral chemotherapy exposure. This randomized cross-over study compared the intratumoral and plasma pharmacokinetics of CPC634 with conventional docetaxel.
METHODS


Adult patients with solid tumors were randomized to receive CPC634 (75 mg/m 2 ) in cycle 1, and conventional docetaxel (75 mg/m 2 ) in cycle 2 or  vice versa . The study was powered to identify a 25% increase of intratumoral total docetaxel exposure after CPC634 infusion compared with conventional docetaxel. Four patients were allocated per tumor sampling time point, that is, 24, 48, 72, and 96 hours, 7 and 14 days after infusion during both cycles. Total docetaxel and released docetaxel from the nanoparticle were determined in tumor tissue derived from a metastatic lesion and in plasma. Pharmacokinetic data were analyzed using linear mixed modeling.
RESULTS


In total, 24 evaluable patients were included. In the tumor, CPC634 exhibited a 461% higher total docetaxel ( P  < 0.001) and a comparable released docetaxel concentration ( P  = 0.43). Plasma AUC inf  was 27% higher ( P  = 0.001) and  C   max  was 91% lower ( P  < 0.001) for CPC634 released docetaxel. The median observed neutrophil count nadir after conventional docetaxel treatment was lower (0.50 × 10 9 /L) compared with CPC634 (4.30 × 10 9 /L;  P  < 0.001).
CONCLUSIONS


Here, we demonstrated that CPC634 enhanced the intratumoral total docetaxel exposure compared with conventional docetaxel. The lower incidence of neutropenia during CPC634 treatment is presumably related to lower plasma  C   max  of released docetaxel. The unique pharmacokinetic profile of CPC634 nanoparticles has the potential to improve docetaxel treatment. A phase II efficacy trial of CPC634 is currently ongoing.",2020,In the tumor CPC634 exhibited a 461% higher total docetaxel ( P <0.001) and a comparable released docetaxel concentration ( P =0.43).,"['24 evaluable patients were included', 'Patients with Solid Tumors', 'Adult patients with solid tumors']","['Nanoparticle Entrapped Docetaxel (CPC634) with Conventional Docetaxel', 'conventional docetaxel (75 mg/m 2 ) in cycle 2 or  vice versa', 'CPC634', 'Total docetaxel and released docetaxel', 'conventional docetaxel', 'CPC634 with conventional docetaxel']","['Plasma AUC inf', 'neutropenia', 'median observed neutrophil count nadir', 'intratumoral total docetaxel exposure', 'total docetaxel', 'C max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",4.0,0.0222535,In the tumor CPC634 exhibited a 461% higher total docetaxel ( P <0.001) and a comparable released docetaxel concentration ( P =0.43).,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Atrafi', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ruben A G', 'Initials': 'RAG', 'LastName': 'van Eerden', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marte A M', 'Initials': 'MAM', 'LastName': 'van Hylckama Vlieg', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Martijn P', 'Initials': 'MP', 'LastName': 'Lolkema', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Moelker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Cristianne J', 'Initials': 'CJ', 'LastName': 'Rijcken', 'Affiliation': 'Cristal Therapeutics, Maastricht, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hanssen', 'Affiliation': 'Cristal Therapeutics, Maastricht, the Netherlands.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sparreboom', 'Affiliation': 'Division of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ferry A L M', 'Initials': 'FALM', 'LastName': 'Eskens', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands. s.koolen@erasmusmc.nl.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0008']
287,30415354,Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin.,"BACKGROUND


Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs, such as antibiotics. The pharmacokinetics of oral amoxicillin after Roux-en-Y gastric bypass (RYGB) surgery is unknown.
OBJECTIVES


The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin.
METHODS


This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n = 8) received an amoxicillin 500 mg capsule orally before and 2 months after the RYGB surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS).
RESULTS


After the surgery, the mean weight loss was 17.03 ± 5.51 kg, and mean body mass index (BMI) decreased from 46.21 ± 2.82 to 38.82 ± 3.32 kg/m 2 . The mean amoxicillin area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC 0-tlast ) increased significantly (3.5-fold); the maximum plasma concentration (C max ) increased 2.8-fold after the bariatric surgery. No correlation was found between amoxicillin absorption, BMI, and weight loss percentage.
CONCLUSION


The alterations observed in the amoxicillin pharmacokinetics suggest that obese subjects included in this trial had a substantially increase in amoxicillin systemic exposure after RYGB surgery. However, despite this increase, its exposure was lower than the values reported for non-obese volunteers.
TRIAL REGISTRATION


Identifiers: NCT03588273.",2019,"No correlation was found between amoxicillin absorption, BMI, and weight loss percentage.
","['obese subjects (n\u2009=\u20098) received an', 'obese subjects']","['Amoxicillin', 'amoxicillin', 'amoxicillin 500\xa0mg capsule', 'oral amoxicillin after Roux-en-Y gastric bypass (RYGB) surgery', 'Bariatric Surgery']","['mean amoxicillin area under the plasma concentration', 'mean weight loss', 'amoxicillin systemic exposure', 'amoxicillin plasma concentration', 'mean body mass index (BMI', 'amoxicillin absorption, BMI, and weight loss percentage', 'maximum plasma concentration (C max ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0993263', 'cui_str': 'Amoxicillin 500 MG'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0283934,"No correlation was found between amoxicillin absorption, BMI, and weight loss percentage.
","[{'ForeName': 'Marina Becker Sales', 'Initials': 'MBS', 'LastName': 'Rocha', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil. marinabecker@hotmail.com.br.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': 'Faculty of Medical Sciences, Department of Pharmacology, State University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Francisco Ney', 'Initials': 'FN', 'LastName': 'Lemos', 'Affiliation': 'Unit of Bariatric Surgery, Hospital General Dr. César Cals, Avenida Imperador, 545, centro, Fortaleza, 60015-152, CE, Brazil.'}, {'ForeName': 'Rodrigo Feitosa', 'Initials': 'RF', 'LastName': 'de Albuquerque Lima Babadopulos', 'Affiliation': 'Unit of Bariatric Surgery, Hospital General Dr. César Cals, Avenida Imperador, 545, centro, Fortaleza, 60015-152, CE, Brazil.'}, {'ForeName': 'Andrea Vieira Pontes', 'Initials': 'AVP', 'LastName': 'Rohleder', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil.'}, {'ForeName': 'Francisco Vagnaldo', 'Initials': 'FV', 'LastName': 'Fechine', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil.'}, {'ForeName': 'Natalícia J', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': 'Faculty of Medical Sciences, Department of Pharmacology, State University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': 'Department of Pharmacology, Metropolitan University of Santos, Santos, Brazil.'}, {'ForeName': 'Demetrius Fernandes', 'Initials': 'DF', 'LastName': 'do Nascimento', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil.'}, {'ForeName': 'Manoel Odorico', 'Initials': 'MO', 'LastName': 'de Moraes', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil.'}, {'ForeName': 'Maria Elisabete Amaral', 'Initials': 'MEA', 'LastName': 'de Moraes', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC), Rua Cel. Nunes de Melo 1000 - Rodolfo Teófilo, Fortaleza, Ceará, 60430-275, Brazil.'}]",Obesity surgery,['10.1007/s11695-018-3591-3']
288,32319465,Chemical stability of fructans in apple beverages and their influence on chronic constipation.,"The aim of this study was to analyse the concentration of reducing sugars in beverages based on apple juice with the addition of 2 and 4% of native and high polymerized inulin as well as oligofructose. Moreover, the effect of the consumption of this potentially prebiotic beverage containing highly polymerized inulin (12 g per 300 mL) on constipation was analysed. Pasteurization of the studied beverages followed by 120-day storage at ambient temperature, carried out in three independent trials, did not cause the hydrolysis of fructans into reducing sugars. Sensory analysis showed that the presence of fructans in beverages based on apple juice did not change the colour, clarity, odour, flavour, sweetness and acidity in comparison to apple juice. A placebo-controlled, randomized study involving 20 volunteers of age 20-29 with symptoms related to chronic constipation showed that the consumption of juice enriched with highly polymerized inulin significantly (p≤ 0.05) increased the frequency of bowel movements and facilitated defecation. The final conclusion is that fructans in beverages based on apple juice are chemically stable, do not affect sensory sensation and can help those with chronic constipation.",2020,"Sensory analysis showed that the presence of fructans in beverages based on apple juice did not change the colour, clarity, odour, flavour, sweetness and acidity in comparison to apple juice.",['20 volunteers of age 20-29 with symptoms related to chronic constipation'],"['placebo', 'prebiotic beverage containing highly polymerized inulin']","['colour, clarity, odour, flavour, sweetness and acidity', 'constipation', 'frequency of bowel movements and facilitated defecation', 'chronic constipation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}]",20.0,0.0357815,"Sensory analysis showed that the presence of fructans in beverages based on apple juice did not change the colour, clarity, odour, flavour, sweetness and acidity in comparison to apple juice.","[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Glibowski', 'Affiliation': 'Department of Biotechnology, Microbiology and Human Nutrition, University of Life Science in Lublin, Skromna St. 8, 20-704 Lublin, Poland. pawel.glibowski@up.lublin.pl.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Skrzypek', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Ćwiklińska', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Drozd', 'Affiliation': ''}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kowalska', 'Affiliation': ''}]",Food & function,['10.1039/c9fo02596k']
289,32050940,Show cards of the Global Physical Activity Questionnaire (GPAQ) - do they impact validity? A crossover study.,"BACKGROUND


The Global Physical Activity Questionnaire (GPAQ) is applied internationally as a tool to assess the level of physical activity. The GPAQ was designed as an interview, including the use of show cards, which visualise activities of moderate and intensive physical activity and support the distinction between these intensities. The self-administered version of the GPAQ is used in the application-oriented research for reasons of economy and practicality. However, the use of show cards often remains unknown. The aim of the present study was to examine differences in validity between two self-administered versions of the GPAQ with and without show cards.
METHODS


In this crossover study, two groups (n = 54; 57.4% female; 28.3 ± 12.2 years) received the GPAQ with or without show cards after 7 days and the respective other version after additional 7 days. For validation, all participants wore an accelerometer (ActiGraph GT3X+) on all 14 days. Differences between GPAQ versions and accelerometer data were compared by Wilcoxon signed rank test. Additionally, Spearman analyses and Bland-Altman plots were calculated.
RESULTS


No statistically significant difference between the GPAQ versions could be found in regard to the accuracy of physical activity assessment (p > 0.05). Both GPAQ versions show similar correlation coefficients for vigorous physical activity (rho = 0.31-0.42) and sedentary behaviour (rho = 0.29-0.32). No statistically significant correlation was found for physical activity of moderate intensity. The Bland-Altman plots support these results, as both GPAQ versions have the same trends in terms of overestimation and underestimation of physical activity.
CONCLUSION


The use of show cards had no significant impact on questionnaire validity. Therefore, both GPAQ versions can be applied interchangeably. Nevertheless the exact description of application of the GPAQ is desirable in terms of reproducibility and transparent scientific research.",2020,No statistically significant difference between the GPAQ versions could be found in regard to the accuracy of physical activity assessment (p > 0.05).,['two groups (n\u2009=\u200954; 57.4% female; 28.3\u2009±\u200912.2\u2009years'],"['accelerometer (ActiGraph GT3X', 'Global Physical Activity Questionnaire (GPAQ', 'GPAQ with or without show cards']","['vigorous physical activity', 'accuracy of physical activity assessment', 'Global Physical Activity Questionnaire (GPAQ', 'physical activity of moderate intensity', 'questionnaire validity', 'sedentary behaviour']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301988', 'cui_str': 'Physical activity assessment'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]",,0.0196063,No statistically significant difference between the GPAQ versions could be found in regard to the accuracy of physical activity assessment (p > 0.05).,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Rudolf', 'Affiliation': 'Institute of Movement Therapy and movement-oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany. k.rudolf@dshs-koeln.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lammer', 'Affiliation': 'Institute of Movement Therapy and movement-oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Stassen', 'Affiliation': 'Institute of Movement Therapy and movement-oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Froböse', 'Affiliation': 'Institute of Movement Therapy and movement-oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaller', 'Affiliation': 'Institute of Movement Therapy and movement-oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}]",BMC public health,['10.1186/s12889-020-8312-x']
290,32320100,Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty.,"AIMS AND OBJECTIVES


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


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


Randomised controlled superiority clinical trial.
METHODS


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


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


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


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


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


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15299']
291,32319168,"Efficacy and safety of evogliptin treatment in patients with type 2 diabetes: A multicentre, active-controlled, randomized, double-blind study with open-label extension (the EVERGREEN study).","AIM


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


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


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


In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin. It was maintained at week 24 with a 0.94% reduction in HbA1c. Evogliptin therapy improved glycaemic variability without causing any serious adverse events in patients with type 2 diabetes.",2020,"In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin.","['patients with T2DM', '207 patients with T2DM who had HbA1c levels of 7.0-10.0', 'patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes']","['linagliptin/evogliptin', 'evogliptin 5\u2009mg (n\xa0=\xa0102) or linagliptin', 'evogliptin treatment', 'evogliptin', 'evogliptin/evogliptin', 'Evogliptin therapy', 'linagliptin']","['mean changes in HbA1c', 'Efficacy and safety', 'glycemic variability', 'efficacy and safety', 'mean amplitude of glycemic excursion (MAGE) assessed by continuous glucose monitoring', 'incidence and types of adverse events', 'change in MAGE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",207.0,0.0933063,"In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin.","[{'ForeName': 'Gyuri', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Hyuk-Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ie B', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Kyu J', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Kangdong Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Korea.'}, {'ForeName': 'Su K', 'Initials': 'SK', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.'}, {'ForeName': 'Hye S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'Seok W', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sin G', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Min K', 'Initials': 'MK', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, College of Medicine University of Ulsan, Ulsan, Korea.'}, {'ForeName': 'Choon H', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Kang S', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Eulji University Hospital, Daejeon, Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Dong J', 'Initials': 'DJ', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Chang B', 'Initials': 'CB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Tae H', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.'}, {'ForeName': 'Moon-Kyu', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14061']
292,31108553,[Supporting Patients with Diabetes mellitus type 2 and Obesity in Transfer of Medically Indicated Lifestyle Changes into Everyday Life by a Planning Competence Training in a Randomized Controlled Trial].,"BACKGROUND


Patients with Diabetes mellitus type 2 and/or obesity have difficulties to transfer medically indicated lifestyle changes into everyday life. Hence, this study investigates whether a planning competence training (Planungskompetenztraining, PKT) can support participants of a medical rehabilitation program to foster lifestyle change.
METHOD


467 patients participated in study. Those patients regularly took part in a 3-week program of a rehabilitation clinic between 12/2012 and 08/2014. Using a randomized control group design, training and aftercare effects were controlled (one experimental group [EG] and 3 control groups [KG].
RESULTS


In general, there were no significant differences between the 4 study groups based on an intention-to-treat-analysis. Significant differences were calculated in per-protocol-analysis. Additionally, differences were primarily revealed in a 2 group comparison between participants who participated at training (EG-A and KG-B) vs. those who did not (KG-C und KG-D).
CONCLUSION


The implementation of the current training version cannot be recommended for medical rehabilitation. However, in consideration of relevant results a modification of the program could make sense.",2020,"In general, there were no significant differences between the 4 study groups based on an intention-to-treat-analysis.","['Patients with Diabetes mellitus type 2 and/or obesity', 'participants of a medical rehabilitation program to foster lifestyle change', '467 patients participated in study']","['planning competence training (Planungskompetenztraining, PKT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],467.0,0.0320092,"In general, there were no significant differences between the 4 study groups based on an intention-to-treat-analysis.","[{'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Arling', 'Affiliation': 'Institut für Psychologie, Lehr- und Forschungsgebiet Gesundheitspsychologie; RWTH Aachen.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Huth', 'Affiliation': 'Klinik Niederrhein.'}, {'ForeName': 'Veneta', 'Initials': 'V', 'LastName': 'Slavchova', 'Affiliation': 'Institut für Psychologie, Lehr- und Forschungsgebiet Gesundheitspsychologie; RWTH Aachen.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Pollmann', 'Affiliation': 'Klinik Niederrhein.'}]",Die Rehabilitation,['10.1055/a-0891-3505']
293,32315444,Adjunctive effect of mouthrinse on treatment of peri-implant mucositis using mechanical debridement: A randomized clinical trial.,"AIM


To study effect of delmopinol hydrochloride (DEL) in comparison with chlorhexidine digluconate (CHX) and a placebo (PLA) in addition to non-surgical mechanical debridement in patients with peri-implant mucositis.
MATERIALS AND METHODS


Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis were randomly assigned to one of three study groups (DEL, CHX and PLA). Professional non-surgical mechanical debridement was performed at baseline. Mouth rinsing was carried out by the patients twice a day in addition to their regular oral hygiene practices. Assessments of efficacy were performed for the primary outcome - Implant bleeding on probing (IBOP%) and secondary outcomes - modified Bleeding Index (mBI) and modified Plaque Index (mPI) at 1 and 3 months.
RESULTS


At 3 months, there was statistically significant reduction in IBOP% and mBI within the study groups compared to baseline. However, there was no statistically significant difference between the study groups at 3 months follow-up. Moreover, there was a statistically significant difference according to mPI at 1 month between the chlorhexidine and placebo group (p = .004).
CONCLUSIONS


This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis. The clinical effects between groups were comparable.",2020,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"['Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis', 'patients with peri-implant mucositis']","['mechanical debridement combined with oral hygiene instruction', 'mouthrinse', 'mechanical debridement', 'placebo', 'delmopinol hydrochloride (DEL', 'chlorhexidine', 'placebo (PLA', 'chlorhexidine digluconate (CHX']","['Implant bleeding on probing sites (IBOP%) and secondary outcomes the modified Bleeding Index (mBI), modified Plaque Index (mPI', 'IBOP% and mBI', 'peri-implant mucositis']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0166532', 'cui_str': 'delmopinol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449996', 'cui_str': 'Probe location'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]",89.0,0.0295568,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Journal of clinical periodontology,['10.1111/jcpe.13295']
294,30578883,Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis.,"BACKGROUND


In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated versus 19% of placebo-treated patients with eosinophilic granulomatosis with polyangiitis (EGPA) achieved protocol-defined remission.
OBJECTIVE


We sought to investigate post hoc the clinical benefit of mepolizumab in patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses.
METHODS


The randomized, placebo-controlled, double-blind, parallel-group trial recruited patients with relapsing/refractory EGPA receiving stable OGCs (prednisolone/prednisone, ≥7.5-50 mg/d) for 4 or more weeks. Patients received 300 mg of subcutaneous mepolizumab or placebo every 4 weeks for 52 weeks. Clinical benefit was defined post hoc as follows: remission at any time (2 definitions used), 50% or greater OGC dose reduction during weeks 48 to 52, or no EGPA relapses. The 2 remission definitions were Birmingham Vasculitis Activity Score of 0 plus OGC dose of 4 mg/d or less (remission 1/clinical benefit 1) or 7.5 mg/d or less (remission 2/clinical benefit 2). Clinical benefit was assessed in all patients and among subgroups with a baseline blood eosinophil count of less than 150 cells/μL, baseline OGC dosage of greater than 20 mg/d, or weight of greater than 85 kg.
RESULTS


With mepolizumab versus placebo, 78% versus 32% of patients experienced clinical benefit 1, and 87% versus 53% of patients experienced clinical benefit 2 (both P < .001). Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
CONCLUSION


When a comprehensive definition of clinical benefit was applied to data from a randomized controlled trial, 78% to 87% of patients with EGPA experienced benefit with mepolizumab.",2019,"Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
","['treated patients with eosinophilic granulomatosis with polyangiitis (EGPA', ' ≥7.5-50\xa0mg/d) for 4 or more weeks', 'all patients and among subgroups with a baseline blood eosinophil count of less than 150\xa0cells/μL, baseline OGC dosage of greater than 20\xa0mg/d, or weight of greater than 85\xa0kg', 'patients with eosinophilic granulomatosis with polyangiitis', 'patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses', 'patients with relapsing/refractory EGPA receiving stable']","['mepolizumab', 'OGCs (prednisolone/prednisone', 'subcutaneous mepolizumab or placebo', 'placebo']","['Birmingham Vasculitis Activity Score', 'blood eosinophil count']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008728', 'cui_str': 'Allergic Granulomatosis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2609436', 'cui_str': 'Vasculitis (SMQ)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.433684,"Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Steinfeld', 'Affiliation': 'Respiratory TAU & Flexible Discovery Unit, GlaxoSmithKline, Philadelphia, Pa.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Research and Development, Immuno-Inflammation TAU, Uxbridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Research & Development, Statistics, Programming and Data Standards, GlaxoSmithKline, Stockley Park West, Uxbridge, United Kingdom.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, Calif.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Cid', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Gleich', 'Affiliation': 'Departments of Dermatology and Medicine, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Paneez', 'Initials': 'P', 'LastName': 'Khoury', 'Affiliation': 'Human Eosinophil Section, Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Department of Rheumatic and Immunologic Diseases, Center for Vasculitis Care and Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Division of Rheumatology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Moosig', 'Affiliation': 'Rheumazentrum, Schleswig-Holstein Mitte, Neumünster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Weller', 'Affiliation': 'Divisions of Allergy and Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colo. Electronic address: wechslerm@njhealth.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.11.041']
295,32311473,Risk of target non-attainment in obese compared to non-obese patients in calculated linezolid therapy.,"OBJECTIVES


The aim was to characterize linezolid population pharmacokinetics in plasma and interstitial space fluid of subcutaneous adipose tissue (target site) of obese compared with non-obese patients and to determine dosing regimens enabling adequate therapy using Monte Carlo simulations.
METHODS


In this prospective, parallel group, open-label, controlled, single-centre trial, 30 surgery patients (15 obese, 15 non-obese) received 600 mg of intravenous linezolid. A population pharmacokinetic analysis characterizing plasma and microdialysis-derived target site pharmacokinetics was followed by Monte Carlo simulations using twice/thrice daily 600-1200 mg short-term and extended infusions of linezolid. Adequacy of therapy was assessed by the probability of pharmacokinetic/pharmacodynamic target attainment for time and exposure-related indices.
RESULTS


In the model, lean body weight and obesity status largely explained between-patient variability in linezolid PK parameters (12.0-44.9%). Both factors caused lower area under the concentration-time curve in typical obese patients in plasma (-20.4%, 95% CI -22.0% to -15.9%) and at target-site (-37.7%, 95% CI -47.1% to -24.2%) compared with non-obese patients. Probability of target attainment showed improvement with increasing linezolid doses. Depending on lean body weight, adequate therapy was partially attained for 900- and 1200-mg linezolid doses and minimum inhibitory concentrations (MICs) ≤2 mg/L (probability of target attainment 62.5-100%) but could not be reached for MIC = 4 mg/L (probability of target attainment ≤82.3%). Additionally, lower linezolid distribution into the target site in obese patients as described above might compromise the plasma-based probability of target attainment analysis.
DISCUSSION


This analysis revealed risks of linezolid underdosing in empirical antibiotic therapy of most resistant bacteria for obese and non-obese patients. Doubling the standard dose is associated with adequate probability of target attainment throughout most body masses for MIC ≤2 mg/L. Further clinical studies with adjusted dosing regimens in for example intensive care patients are needed.",2020,"Doubling the standard dose is associated with adequate probability of target attainment throughout most body masses for MIC≤2 mg/L. Further clinical studies with adjusted dosing regimens in e.g. intensive care patients are needed.
","['30 surgery patients (15 obese, 15 non-obese', 'obese and non-obese patients', 'obese patients']",['linezolid'],['probability of pharmacokinetic/pharmacodynamic target attainment for time and exposure related indices'],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0838378,"Doubling the standard dose is associated with adequate probability of target attainment throughout most body masses for MIC≤2 mg/L. Further clinical studies with adjusted dosing regimens in e.g. intensive care patients are needed.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ehmann', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry Freie Universitaet Berlin, Institute of Pharmacy, Berlin, Germany; Graduate Reserarch Training Program PharMetrX, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'University of Leipzig, Department of Anaesthesiology and Intensive Care Medicine, Leipzig, Germany; University of Leipzig, Integrated Research and Treatment Centre (IFB) Adiposity Diseases, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Busse', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry Freie Universitaet Berlin, Institute of Pharmacy, Berlin, Germany; Graduate Reserarch Training Program PharMetrX, Berlin, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'University of Leipzig, Clinical Trial Centre Leipzig, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'University of Regensburg, Institute of Pharmacy, Regensburg, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Huisinga', 'Affiliation': 'Institute of Mathematics, University of Potsdam, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'University of Leipzig, Department of Anaesthesiology and Intensive Care Medicine, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Medical University of Vienna, Department of Clinical Pharmacology, Vienna, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': 'University of Leipzig, Integrated Research and Treatment Centre (IFB) Adiposity Diseases, Leipzig, Germany; Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy, Bergmannstrost Hospital Halle, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kloft', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry Freie Universitaet Berlin, Institute of Pharmacy, Berlin, Germany. Electronic address: charlotte.kloft@fu-berlin.de.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.04.009']
296,32311700,Effects of vitamin D supplementation on circulating concentrations of growth factors and immune-mediators in healthy women during pregnancy.,"BACKGROUND


For the second aim of the Kellogg Foundation grant, this double-blind RCT investigated the impact of plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D) on plasma immune-mediators during pregnancy. We hypothesized that higher 25(OH)D concentrations would associate with reduced pro-inflammatory and increased tolerogenic immune-mediator concentrations.
METHODS


Pregnant women enrolled at 10-14 weeks gestation were randomized to 400 or 4400 IU vitamin D 3 /day. Data on health, safety, circulating 25(OH)D, and 9 immune-mediators were collected at each trimester. Associations between immune-mediators and 25(OH)D at baseline and at second and third trimesters were examined.
RESULTS


Baseline TGF-β and second and third trimesters IFN-γ and IL-2 were associated with baseline 25(OH)D. Baseline immune-mediators were associated with immune-mediators at second and third trimesters for all immune-mediators except IL-5 and IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters.
CONCLUSIONS


Both treatment groups had increased 25(OH)D at second and third trimesters, greatest in the 4400 IU group. Though associations between baseline 25(OH)D and baseline TGF-β and second and third trimester IFN-γ and IL-2 were noted, vitamin D supplementation throughout pregnancy did not impact immune-mediators at later trimesters. Supplementing with vitamin D before conception conceivably influences immune-mediator responses during pregnancy.
IMPACT


In this vitamin D supplementation clinical trial, baseline (first trimester) but not increasing plasma 25(OH)D concentration impacted select plasma immune-mediator profiles in pregnant women.Baseline 25(OH)D was associated with baseline TGF-β and with IFN-γ and IL-2 at second and third trimesters.Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4 were associated with concentrations at second and third trimesters for respective immune-mediators; however, 25(OH)D concentration at second and third trimesters were not.Some racial differences existed in immune-mediator concentrations at baseline and at second and third trimesters.This study assesses the impact of vitamin D supplementation on multiple immune-mediators in pregnant women of different racial/ethnic groups using longitudinal data from a relatively large randomized controlled trial.This study found that race was associated with baseline TGF-β, VEGF, and IL-10 and with IL-10 at second and third trimesters, a novel finding that sheds light where relationships were less well defined.The results of this study suggest that vitamin D supplementation before conception or early in pregnancy, rather than during pregnancy, may be necessary to significantly impact immune-mediator response.This study sets premise for future clinical trials to evaluate the effect of vitamin D supplementation before conception or prior to pregnancy.",2020,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters.
","['pregnant women', 'Pregnant women enrolled at 10-14 weeks gestation', 'pregnant women of different racial/ethnic groups', 'healthy women during pregnancy']","['vitamin D 3 /day', 'vitamin D supplementation', 'plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D', 'vitamin D']","['Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4', 'baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters', 'immune-mediator concentrations', 'health, safety, circulating 25(OH)D, and 9 immune-mediators', 'multiple immune-mediators', '25(OH)D concentration', 'immune-mediator responses', 'baseline TGF-β, VEGF, and IL-10 and with IL-10', 'circulating concentrations of growth factors and immune-mediators']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]",,0.420897,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters.
","[{'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Khatiwada', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Mulligan', 'Affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hewison', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Medical School, IBR Tower, Level 2, Birmingham, B15 2TT, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Danforth A', 'Initials': 'DA', 'LastName': 'Newton', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hawrylowicz', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA. wagnercl@musc.edu.'}]",Pediatric research,['10.1038/s41390-020-0885-7']
297,32315648,Validity and Responsiveness of Floor Sitting-Rising Test in Post-Total Knee Arthroplasty: A Cohort Study.,"OBJECTIVES


To assess the construct validity and responsiveness of the floor sitting-rising test (SRT) in individuals with total knee arthroplasty (TKA).
DESIGN


Cohort study with 6-month follow-up. Secondary analysis using data from a randomized controlled trial.
SETTING


An outpatient rehabilitation research center.
PARTICIPANTS


Participants (N=240) enrolled in the parent study who had unilateral primary TKA.
INTERVENTION


Participants in the parent study underwent 12 weeks of exercise programs.
MAIN OUTCOME MEASURES


Validity analysis correlated baseline data of participants who completed the SRT and measures of knee motion, muscle strength, performance-based tests, and patient-reported outcomes of physical and psychosocial function. Responsiveness analysis used the 3- and 6-month follow-up data. Effect sizes were calculated using changes from baseline. Areas under the receiving operating characteristics curve were calculated using a global rating of change as the external anchor.
RESULTS


Of the 240 participants (148 women; age, 70±7y), 180 (75%) were able to perform the SRT at baseline. Performers scored significantly better in all physical function tests (P<.0001) than nonperformers. SRT scores generally converged with measures of knee impairment and performance-based tests (associations ranged from small [r=0.15; P=.0516] to moderate [r=0.52; P<.0001]). SRT scores associated with self-efficacy for function (r=0.34; P<.0001) and fear of falls (r=-0.25; P=.001). At 3 (n=174) and 6 months (n=160), SRT effect sizes were 0.38 (95% confidence interval, 0.25-0.52) and 0.42 (95% confidence interval, 0.25-0.60), and areas under the curve were 0.59 (95% confidence interval, 0.49-0.69) and 0.62 (95% confidence interval, 0.52-0.73), respectively.
CONCLUSIONS


The results add evidence to the validity of the SRT in patients after TKA. The strength of the associations suggests that the SRT measures a physical function construct not captured by the other tests. The magnitude of indices of responsiveness for the SRT were similar to other performance-based tests, indicating comparable responsiveness to more widespread tests of functional performance.",2020,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"['All 240 participants enrolled in the parent study who had unilateral primary TKA', '240 participants (148 female, age 70±7SD years), 180 (75', 'Post-Total Knee Arthroplasty', 'Outpatient rehabilitation research center', 'individuals with total knee arthroplasty (TKA']","['exercise programs', 'floor sitting-rising test (SRT']","['fear of falls', 'SRT effect sizes', 'SRT scores', 'Validity and responsiveness of floor Sitting-Rising Test', 'knee motion, muscle strength, performance-based tests, and patient-reported outcomes (PROs) of physical and psychosocial function']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",240.0,0.113594,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"[{'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Alomar', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Maria Beatriz C', 'Initials': 'MBC', 'LastName': 'Catelani', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clair N', 'Initials': 'CN', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Patterson', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Artman', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA. Electronic address: spiva@pitt.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.012']
298,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
299,29737226,Blood pressure reduction in hypertensive acute ischemic stroke patients does not affect cerebral blood flow.,"The effect of blood pressure (BP) reduction on cerebral blood flow (CBF) in acute ischemic stroke is unknown. We measured regional CBF with perfusion-weighted MRI before and after BP treatment in a three-armed non-randomized prospective controlled trial. Treatment arm assignment was based on acute mean arterial pressure (MAP). Patients with (MAP) >120 mmHg ( n  = 14) were treated with intravenous labetalol and sublingual (SL) nitroglycerin (labetalol group). Those with MAP 100-120 mmHg ( n  = 17) were treated with SL nitroglycerin (0.3 mg) ('NTG Group') and those with baseline MAP<100 mmHg ( n  = 18) were not treated with antihypertensive drugs (untreated group). Forty-nine patients (18 female, mean age 65.3 ± 12.9 years) were serially imaged. Labetalol reduced MAP by 12.5 (5.7-17.7) mmHg,  p  = 0.0002. MAP remained stable in the NTG (6.0 (0.4-16,  p  = 0.3) mmHg and untreated groups (-0.3 (-2.3-7.0,  p  = 0.2) mmHg. The volume of total hypoperfused tissue (CBF<18 ml/100 g/min) did not increase after labetalol (-1.1 ((-6.5)-(-0.2)) ml,  p  = 0.1), NTG (0 ((-1.5)-4.5) ml,  p  = 0.72), or no treatment 0.25 ((-10.1)-4.5) ml,  p  = 0.87). Antihypertensive therapy, based on presenting BP, in acute stroke patients was not associated with an increased volume of total hypoperfused tissue.",2019,"Labetalol reduced MAP by 12.5 (5.7-17.7) mmHg, p = 0.0002.","['hypertensive acute ischemic stroke patients', 'acute stroke patients', 'Forty-nine patients (18 female, mean age 65.3\u2009±\u200912.9 years', 'Patients with (MAP) >120\u2009mmHg ( n\u2009=\u200914', 'acute ischemic stroke']","['NTG', 'baseline MAP<100\u2009mmHg', 'blood pressure (BP) reduction', 'Labetalol', 'intravenous labetalol and sublingual (SL) nitroglycerin (labetalol group', 'antihypertensive drugs', 'SL nitroglycerin']","['cerebral blood flow', 'acute mean arterial pressure (MAP', 'Blood pressure reduction', 'cerebral blood flow (CBF', 'volume of total hypoperfused tissue']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",,0.0399341,"Labetalol reduced MAP by 12.5 (5.7-17.7) mmHg, p = 0.0002.","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kate', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Asdaghi', 'Affiliation': '2 Department of Neurology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Gioia', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': '3 Department of Medicine, Division of General Internal Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jeerakathil', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Emery', 'Affiliation': '4 Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beaulieu', 'Affiliation': '5 Department of Biomedical Engineering, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Butcher', 'Affiliation': '1 Division of Neurology, University of Alberta, Edmonton, Canada.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X18774708']
300,32312333,"Effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease: a double-blind randomised controlled clinical trial.","Non-alcoholic fatty liver disease (NAFLD) includes a range of disorders from simple steatosis to non-alcoholic steatohepatitis. There is no proven drug treatment for NAFLD, and diet modification is considered part of the main line of treatment for this disease. The aim of this study was to investigate the efficacy of garlic supplementation in NAFLD patients. The effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile was investigated in NAFLD patients. Ninety NAFLD patients were randomly assigned to take either a garlic powder supplement or a placebo for 12 weeks. The treatment group received four tablets of garlic daily (each tablet contained 400 mg garlic powder). The control group received four tablets of placebo (each placebo contained 400 mg starch). At the end of the study, hepatic steatosis was significantly reduced in the treatment group compared with the control group (P = 0·001). In addition, a significant decrease was seen in the serum concentration of alanine transaminase (P < 0·001), aspartate transaminase (P = 0·002), γ-glutamyltransferase (P = 0·003) as well as total cholesterol (P = 0·009), TAG (P < 0·001), HDL-cholesterol (P < 0·001) and LDL-cholesterol (P = 0·01) in the treatment group compared with the control group. No significant difference was seen between the two groups in serum concentration of alkaline phosphatase. Overall, garlic powder supplementation improved hepatic features and lipid profile among NAFLD patients.",2020,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"['NAFLD patients', 'Ninety NAFLD patients', 'patients with non-alcoholic fatty liver disease']","['garlic powder supplement or a placebo', 'garlic daily (each tablet contained 400 mg garlic powder', 'placebo (each placebo contained 400 mg starch', 'garlic powder supplementation', 'garlic supplementation']","['gamma-glutamyltransferase', 'total cholesterol', 'serum concentration of alkaline phosphatase', 'hepatic steatosis', 'high-density lipoprotein-cholesterol', 'hepatic features and lipid profile', 'serum concentration of alanine transaminase', 'triglyceride', 'low-density lipoprotein-cholesterol', 'aspartate transaminase', 'hepatic steatosis, liver enzymes, and lipid profile']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",,0.54422,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Department of Nutrition, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine Department, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001403']
301,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES


To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data.
METHODS


8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration.
RESULTS


Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable.
CONCLUSIONS


Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351']
302,32294698,Acute effect of passive cycle-ergometry and functional electrical stimulation on nitrosative stress and inflammatory cytokines in mechanically ventilated critically ill patients: a randomized controlled trial.,"Early mobilization is beneficial for critically ill patients because it reduces muscle weakness acquired in intensive care units. The objective of this study was to assess the effect of functional electrical stimulation (FES) and passive cycle ergometry (PCE) on the nitrous stress and inflammatory cytometry in critically ill patients. This was a controlled, randomized, open clinical trial carried out in a 16-bed intensive care unit. The patients were randomized into four groups: Control group (n=10), did not undergo any therapeutic intervention during the study; PCE group (n=9), lower-limb PCE for 30 cycles/min for 20 min; FES group (n=9), electrical stimulation of quadriceps muscle for 20 min; and FES with PCE group (n=7), patients underwent PCE and FES, with their order determined randomly. The serum levels of nitric oxide, tumor necrosis factor alpha, interferon gamma, and interleukins 6 and 10 were analyzed before and after the intervention. There were no differences in clinical or demographic characteristics between the groups. The results revealed reduced nitric oxide concentrations one hour after using PCE (P<0.001) and FES (P<0.05), thereby indicating that these therapies may reduce cellular nitrosative stress when applied separately. Tumor necrosis factor alpha levels were reduced after the PCE intervention (P=0.049). PCE and FES reduced nitric oxide levels, demonstrating beneficial effects on the reduction of nitrosative stress. PCE was the only treatment that reduced the tumor necrosis factor alpha concentration.",2020,"The results revealed reduced nitric oxide concentrations one hour after using PCE (P<0.001) and FES (P<0.05), thereby indicating that these therapies may reduce cellular nitrosative stress when applied separately.","['critically ill patients', '16-bed intensive care unit', 'mechanically ventilated critically ill patients']","['PCE and FES', 'functional electrical stimulation (FES) and passive cycle ergometry (PCE', 'Control group (n=10), did not undergo any therapeutic intervention during the study; PCE', 'passive cycle-ergometry and functional electrical stimulation', 'lower-limb PCE for 30 cycles/min for 20 min; FES', 'electrical stimulation of quadriceps muscle for 20 min; and FES with PCE', 'PCE']","['serum levels of nitric oxide, tumor necrosis factor alpha, interferon gamma, and interleukins 6 and 10', 'Tumor necrosis factor alpha levels', 'tumor necrosis factor alpha concentration', 'nitric oxide levels', 'clinical or demographic characteristics', 'nitric oxide concentrations', 'nitrosative stress and inflammatory cytokines', 'cellular nitrosative stress']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}]",,0.0456556,"The results revealed reduced nitric oxide concentrations one hour after using PCE (P<0.001) and FES (P<0.05), thereby indicating that these therapies may reduce cellular nitrosative stress when applied separately.","[{'ForeName': 'E E T', 'Initials': 'EET', 'LastName': 'França', 'Affiliation': 'Departamento de Fisioterapia e Programa de Pós-graduação em Fisioterapia, Universidade Federal da Paraíba, João Pessoa, PB, Brasil.'}, {'ForeName': 'J P V', 'Initials': 'JPV', 'LastName': 'Gomes', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'J M B', 'Initials': 'JMB', 'LastName': 'De Lira', 'Affiliation': 'Programa de Residência de Clínica Médica, Hospital Otávio de Freitas, Recife, PE, Brasil.'}, {'ForeName': 'T C N', 'Initials': 'TCN', 'LastName': 'Amaral', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Vilaça', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'M D S', 'Initials': 'MDS', 'LastName': 'Paiva Júnior', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'U F', 'Initials': 'UF', 'LastName': 'Elihimas Júnior', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'M A V', 'Initials': 'MAV', 'LastName': 'Correia Júnior', 'Affiliation': 'Programa de Pós-graduação em Educação Física e Hebiatria, Universidade de Pernambuco, Recife, PE, Brasil.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Forgiarini Júnior', 'Affiliation': 'Departamento de Fisioterapia e Programa de Pós-graduação em Saúde e Desenvolvimento Humano, Universidade La Salle, Canoas, RS, Brasil.'}, {'ForeName': 'M J C', 'Initials': 'MJC', 'LastName': 'Costa', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco, Recife, PE, Brasil.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco, Recife, PE, Brasil.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ribeiro', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Agamenon Magalhães, Recife, PE, Brasil.'}, {'ForeName': 'C M M B', 'Initials': 'CMMB', 'LastName': 'De Castro', 'Affiliation': 'Departamento de Fisioterapia e Medicina Tropical, Universidade Federal de Pernambuco, Recife, PE, Brasil.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20208770']
303,30474791,Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study.,"BACKGROUND


Laparoscopic sleeve gastrectomy (LSG) is defined as the first-step bariatric surgery for the treatment of obesity. Opioid analgesics are often preferred for pain management because of their strong analgesic potentials. However, opioids have undesirable adverse effects.
OBJECTIVES


The objective of this study is to evaluate and compare the influence of IV forms of ibuprofen and paracetamol on pain management and opioid consumption on patients undergoing LSG surgery.
SETTING


This study was conducted at Istanbul Medipol University Hospital.
METHODS


Patients were stratified into three groups. Group I (group ibuprofen, n = 30) was administered 800 mg of IV ibuprofen, group P (group paracetamol, n = 30) was administered 1000 mg of IV paracetamol, and group C (control group, n = 30) was given 100 ml of saline solution. We evaluated opioid consumption and VAS scores postoperatively.
RESULTS


This study included 90 patients who underwent LSG. The use of rescue medication in group I was statistically lower than the other groups. VAS scores in group I and group P at recovery and at 2, 4, 8, 12, and 24 h were lower than those in group C. In particular, the VAS scores in group I at the first 2 h postoperatively were significantly lower than those in group P (p < 0.05). Opioid consumption in group C was significantly higher than the other groups (p < 0.05).
CONCLUSION


Our study suggested that IV ibuprofen resulted in lower pain scores compared to paracetamol by reducing postoperative opioid use in the first 24 h in patients undergoing LSG surgery.",2019,"Opioid consumption in group C was significantly higher than the other groups (p < 0.05).
","['90 patients who underwent LSG', 'This study was conducted at Istanbul Medipol University Hospital', 'Patients were stratified into three groups', 'Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy', 'patients undergoing LSG surgery']","['ibuprofen', 'ibuprofen and paracetamol', 'Ibuprofen and Paracetamol', 'ibuprofen, n\u2009=\u200930) was administered 800\xa0mg of IV ibuprofen, group P (group paracetamol, n\u2009=\u200930) was administered 1000\xa0mg of IV paracetamol, and group C (control group, n\u2009=\u200930) was given 100\xa0ml of saline solution', 'paracetamol', 'Laparoscopic sleeve gastrectomy (LSG']","['pain management and opioid consumption', 'lower pain scores', 'Opioid consumption', 'VAS scores', 'opioid consumption and VAS scores postoperatively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.0308563,"Opioid consumption in group C was significantly higher than the other groups (p < 0.05).
","[{'ForeName': 'Bahadır', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey. baha_cftci@hotmail.com.'}, {'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Erzurum Regional Training and Research Hospital, Yakutiye, 25070, Erzurum, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kaciroglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Fatih Sultan Mehmet Training and Research Hospital, Merkez, 34000, Istanbul, Turkey.'}, {'ForeName': 'Muhammet Ahmet', 'Initials': 'MA', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Ozdenkaya', 'Affiliation': 'Department of General Surgery, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-018-3613-1']
304,30756462,Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus.,"AIMS


To quantitatively describe the relationship between dapagliflozin systemic exposure and HbA1c response among patients with type 1 diabetes mellitus (T1DM) and assess the potential impact of covariate effects.
MATERIALS AND METHODS


Individual longitudinal HbA1c data from two phase 3 studies in patients with T1DM (24-week treatment with once-daily dapagliflozin 5 or 10 mg or placebo, with adjustable insulin) were analyzed using a non-linear mixed effect modeling approach. Area under the concentration curve was used to measure dapagliflozin systemic exposure. Baseline HbA1c, estimated glomerular filtration rate, reduction in total insulin dose, baseline glucose concentrations, age, sex, race (Asian vs. non-Asian), and insulin administration method (multiple daily injections vs. insulin pump) were assessed as covariates.
RESULTS


A maximum effect (E max  ) model identified a positive exposure-response relationship. Model-predicted placebo-corrected HbA1c reductions after 24 weeks for dapagliflozin 5- and 10-mg doses were - 0.42% [95% confidence interval (CI) -0.47 to -0.36) and - 0.45% (95% CI -0.50 to -0.40), respectively; baseline HbA1c was ~8.4%. This was in good agreement with actual observations from both studies. Baseline HbA1c was a significant covariate: patients with higher baseline HbA1c were predicted to have greater HbA1c reductions.
CONCLUSIONS


The relationship between dapagliflozin systemic exposure and HbA1c response was successfully described in patients with T1DM. None of the tested covariates affected the efficacy of dapagliflozin to a clinically relevant extent. Therefore, no dose adjustment of dapagliflozin is required in patients with T1DM based on the tested covariates. ClinicalTrials.gov, NCT02268214; NCT02460978.",2019,"Baseline HbA1c was a significant covariate: patients with higher baseline HbA1c were predicted to have greater HbA1c reductions.
","['patients with type 1 diabetes mellitus', 'Individual longitudinal HbA1c data from two phase 3 studies in patients with T1DM (24-week treatment with', 'patients with type 1 diabetes mellitus (T1DM', 'patients with T1DM']","['once-daily dapagliflozin 5 or 10\u2009mg or placebo, with adjustable insulin', 'dapagliflozin']","['Baseline HbA1c, estimated glomerular filtration rate, reduction in total insulin dose, baseline glucose concentrations, age, sex, race (Asian vs. non-Asian), and insulin administration method']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3811844'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",,0.432061,"Baseline HbA1c was a significant covariate: patients with higher baseline HbA1c were predicted to have greater HbA1c reductions.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Åstrand', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Melin', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Ekholm', 'Affiliation': 'Global Medicines Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hamrén', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gaithersburg, Maryland, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13664']
305,30715153,Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001.,"BACKGROUND


Pembrolizumab demonstrated robust antitumor activity and safety in the phase Ib KEYNOTE-001 study (NCT01295827) of advanced melanoma. Five-year outcomes in all patients and treatment-naive patients are reported herein. Patients whose disease progressed following initial response and who received a second course of pembrolizumab were also analyzed.
PATIENTS AND METHODS


Patients aged ≥18 years with previously treated or treatment-naive advanced/metastatic melanoma received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks until disease progression, intolerable toxicity, or patient/investigator decision to withdraw. Kaplan-Meier estimates of overall survival (OS) and progression-free survival (PFS) were calculated. Objective response rate and PFS were based on immune-related response criteria by investigator assessment (data cut-off, September 1, 2017).
RESULTS


KEYNOTE-001 enrolled 655 patients with melanoma; median follow-up was 55 months. Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients; median OS was 23.8 months (95% CI, 20.2-30.4) and 38.6 months (95% CI, 27.2-not reached), respectively. Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months (95% CI, 5.8-11.1) and 16.9 months (95% CI, 9.3-35.5), respectively. Median response duration was not reached; 73% of all responses and 82% of treatment-naive responses were ongoing at data cut-off; the longest response was ongoing at 66 months. Four patients [all with prior response of complete response (CR)] whose disease progressed during observation subsequently received second-course pembrolizumab. One patient each achieved CR and partial response (after data cut-off). Treatment-related AEs (TRAEs) occurred in 86% of patients and resulted in study discontinuation in 7.8%; 17% experienced grade 3/4 TRAE.
CONCLUSIONS


This 5-year analysis of KEYNOTE-001 represents the longest follow-up for pembrolizumab to date and confirms the durable antitumor activity and tolerability of pembrolizumab in advanced melanoma.
CLINICAL TRIAL REGISTRY


ClinicalTrials.gov, NCT01295827.",2019,"Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months (95% CI, 5.8-11.1) and 16.9 months (95% CI, 9.3-35.5), respectively.","['patients with advanced melanoma treated with', 'enrolled 655 patients with melanoma; median follow-up was 55\u2009months', 'Patients aged ≥18\u2009years with previously treated or treatment-naive advanced/metastatic melanoma received']","['pembrolizumab 2\u2009mg/kg every 3\u2009weeks, 10\u2009mg/kg every 3\u2009weeks, or 10\u2009mg/kg', 'pembrolizumab']","['Estimated 5-year PFS rates', 'Objective response rate and PFS', 'Median response duration', 'overall survival (OS) and progression-free survival (PFS', 'antitumor activity and safety', 'complete response (CR', 'Estimated 5-year OS', 'CR and partial response', 'median OS', 'median PFS', 'Treatment-related AEs (TRAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",655.0,0.454713,"Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months (95% CI, 5.8-11.1) and 16.9 months (95% CI, 9.3-35.5), respectively.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Medical Oncology, The Angeles Clinic and Research Institute, Los Angeles, USA. Electronic address: ohamid@theangelesclinic.org.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Dermatology, Gustave Roussy, Villejuif; Department of Medicine, University of Paris-Sud, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Hwu', 'Affiliation': 'Department of Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Medical Oncology, Westmead Hospital, Westmead; Medical Oncology, Melanoma Institute Australia, Sydney; Medical Oncology, Macquarie University, Macquarie Park; Medical Oncology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'Medical Oncology, University of Sydney, Sydney, Australia; Department of Medicine, Centenary Institute, Sydney, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Joseph', 'Affiliation': 'Medical Oncology, Mayo Clinic Cancer Center-Florida, Jacksonville.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, Perlmutter Cancer Center, NYU Langone Health, New York.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dronca', 'Affiliation': 'Medical Oncology, Mayo Clinic Cancer Center-Florida, Jacksonville.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Division of Hematology Oncology, Abramson Cancer Center, Perelman Center for Advanced Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patnaik', 'Affiliation': 'Medical Oncology, South Texas Accelerated Research Therapeutics, San Antonio.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Zarour', 'Affiliation': 'Department of Immunology, University of Pittsburgh Cancer Institute, Pittsburgh, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""Medical Oncology, Melanoma Institute Australia, Sydney; Medical Oncology, University of Sydney, Sydney, Australia; Kinghorn Cancer Centre, St. Vincent's Hospital, Medical Oncology, Garvan Institute of Medical Research, Sydney; Medical Oncology, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Merck & Co., Inc., Kenilworth.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahsan', 'Affiliation': 'Merck & Co., Inc., Kenilworth.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz011']
306,30724009,When basal insulin is not enough: A dose-response relationship between insulin glargine 100 units/mL and glycaemic control.,"AIMS


A post-hoc analysis to assess the impact in people with type 2 diabetes, of increasing doses of basal insulin on glycaemic measures, body weight and hypoglycaemia.
RESEARCH DESIGN AND METHODS


We included data from prospective, randomized controlled treat-to-target trials of ≥24 weeks' duration in people with type 2 diabetes, uncontrolled on metformin and sulphonylureas, and treated with insulin glargine 100 units/mL (U100), who had at least six fasting plasma glucose (FPG) measurements. The impact of insulin dose on glycated haemoglobin (HbA1c) values, FPG, hypoglycaemia incidence (<3.9 mmol/L [70 mg/dL]), and body weight was analysed. A total of 458 participants from three eligible trials were included.
RESULTS


The observed relationship between higher basal insulin doses and glycaemic control was non-linear, with increasing insulin dose leading to smaller reductions in FPG and HbA1c for doses >0.3 IU/kg/d, with a plateauing effect at 0.5 IU/kg/d. Total daily dose of insulin >0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
CONCLUSIONS


This analysis indicates that basal insulin doses >0.5 IU/kg/d have diminishing additional impact on improving glycaemic measures, with the disadvantage of additional weight gain. Clinicians should consider anti-hyperglycaemic treatment intensification at doses approaching 0.5 IU/kg/d.",2019,"0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
","[""≥24 weeks' duration in people with type 2 diabetes, uncontrolled on metformin and sulphonylureas, and treated with"", '458 participants from three eligible trials were included', 'people with type 2 diabetes', '100 units/mL (U100), who had at least six fasting plasma glucose (FPG) measurements']","['insulin glargine', 'insulin ']","['greater weight gain', 'rates of hypoglycaemia', 'glycaemic measures', 'glycated haemoglobin (HbA1c) values, FPG, hypoglycaemia incidence ', 'body weight']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",458.0,0.457284,"0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
","[{'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Skolnik', 'Affiliation': 'Abington Family Medicine, Jefferson Health, Jenkintown, Pennsylvania.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dex', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Traylor', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Xinyi, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Shaefer', 'Affiliation': 'University Medical Group, Augusta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13653']
307,30747773,"Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559).","OBJECTIVES


To assess for the first time the safety and pharmacokinetics of an antiprogrammed cell death-ligand 1 immune checkpoint inhibitor (BMS-936559; Bristol-Myers Squibb, Princeton, NJ) and its effect on immune biomarkers in participants with sepsis-associated immunosuppression.
DESIGN


Randomized, placebo-controlled, dose-escalation.
SETTING


Seven U.S. hospital ICUs.
STUDY POPULATION


Twenty-four participants with sepsis, organ dysfunction (hypotension, acute respiratory failure, and/or acute renal injury), and absolute lymphocyte count less than or equal to 1,100 cells/μL.
INTERVENTIONS


Participants received single-dose BMS-936559 (10-900 mg; n = 20) or placebo (n = 4) infusions. Primary endpoints were death and adverse events; key secondary endpoints included receptor occupancy and monocyte human leukocyte antigen-DR levels.
MEASUREMENTS AND MAIN RESULTS


The treated group was older (median 62 yr treated pooled vs 46 yr placebo), and a greater percentage had more than 2 organ dysfunctions (55% treated pooled vs 25% placebo); other baseline characteristics were comparable. Overall mortality was 25% (10 mg dose: 2/4; 30 mg: 2/4; 100 mg: 1/4; 300 mg: 1/4; 900 mg: 0/4; placebo: 0/4). All participants had adverse events (75% grade 1-2). Seventeen percent had a serious adverse event (3/20 treated pooled, 1/4 placebo), with none deemed drug-related. Adverse events that were potentially immune-related occurred in 54% of participants; most were grade 1-2, none required corticosteroids, and none were deemed drug-related. No significant changes in cytokine levels were observed. Full receptor occupancy was achieved for 28 days after BMS-936559 (900 mg). At the two highest doses, an apparent increase in monocyte human leukocyte antigen-DR expression (> 5,000 monoclonal antibodies/cell) was observed and persisted beyond 28 days.
CONCLUSIONS


In this first clinical evaluation of programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition in sepsis, BMS-936559 was well tolerated, with no evidence of drug-induced hypercytokinemia or cytokine storm, and at higher doses, some indication of restored immune status over 28 days. Further randomized trials on programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition are needed to evaluate its clinical safety and efficacy in patients with sepsis.",2019,"Adverse events that were potentially immune-related occurred in 54% of participants; most were grade 1-2, none required corticosteroids, and none were deemed drug-related.","['patients with sepsis', 'Sepsis', 'participants with sepsis-associated immunosuppression', 'Seven U.S. hospital ICUs', 'Twenty-four participants with sepsis, organ dysfunction (hypotension, acute respiratory failure, and/or acute renal injury), and absolute lymphocyte count less than or equal to 1,100 cells/μL']","['Placebo', 'single-dose BMS-936559', 'placebo', 'BMS-936559']","['2 organ dysfunctions', 'serious adverse event', 'adverse events', 'receptor occupancy and monocyte human leukocyte antigen-DR levels', 'Overall mortality', 'cytokine levels', 'Full receptor occupancy', 'monocyte human leukocyte antigen-DR expression', 'death and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4053660', 'cui_str': 'BMS-936559'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",24.0,0.628585,"Adverse events that were potentially immune-related occurred in 54% of participants; most were grade 1-2, none required corticosteroids, and none were deemed drug-related.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Hotchkiss', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colston', 'Affiliation': 'Department of Anesthesiology, Innovative Medicines Development, Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Yende', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The CRISMA Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Lyle L', 'Initials': 'LL', 'LastName': 'Moldawer', 'Affiliation': 'Department of Surgery, University of Florida College of Medicine, Gainesville, FL.'}, {'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'Department of Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care & Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Coopersmith', 'Affiliation': 'Department of Surgery and Emory Critical Care Center, Emory University, Atlanta, GA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Brakenridge', 'Affiliation': 'Department of Surgery, University of Florida College of Medicine, Gainesville, FL.'}, {'ForeName': 'Florian B', 'Initials': 'FB', 'LastName': 'Mayr', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Anesthesiology, Innovative Medicines Development, Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Catlett', 'Affiliation': 'Department of Anesthesiology, Innovative Medicines Development, Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Ihab G', 'Initials': 'IG', 'LastName': 'Girgis', 'Affiliation': 'Department of Anesthesiology, Innovative Medicines Development, Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Grasela', 'Affiliation': 'Department of Anesthesiology, Innovative Medicines Development, Bristol-Myers Squibb, Princeton, NJ.'}]",Critical care medicine,['10.1097/CCM.0000000000003685']
308,30753272,Overall survival and updated progression-free survival outcomes in a randomized phase II study of combination cediranib and olaparib versus olaparib in relapsed platinum-sensitive ovarian cancer.,"BACKGROUND


Olaparib is a poly(ADP-ribose) polymerase inhibitor and cediranib is an oral anti-angiogenic. In the primary analysis of this phase II study, combination cediranib/olaparib improved progression-free survival (PFS) compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. This updated analysis was conducted to characterize overall survival (OS) and update PFS outcomes.
PATIENTS AND METHODS


Ninety patients were enrolled to this randomized, open-label, phase II study between October 2011 and June 2013 across nine United States-based academic centers. Data cut-off was 21 December 2016, with a median follow-up of 46 months. Participants had relapsed platinum-sensitive ovarian cancer of high-grade serous or endometrioid histology or had a deleterious germline BRCA1/2 mutation (gBRCAm). Participants were randomized to receive olaparib capsules 400 mg twice daily or cediranib 30 mg daily and olaparib capsules 200 mg twice daily until disease progression.
RESULTS


In this updated analysis, median PFS remained significantly longer with cediranib/olaparib compared with olaparib alone (16.5 versus 8.2 months, hazard ratio 0.50; P = 0.007). Subset analyses within stratum defined by BRCA status demonstrated statistically significant improvement in PFS (23.7 versus 5.7 months, P = 0.002) and OS (37.8 versus 23.0 months, P = 0.047) in gBRCA wild-type/unknown patients, although OS was not statistically different in the overall study population (44.2 versus 33.3 months, hazard ratio 0.64; P = 0.11). PFS and OS appeared similar between the two arms in gBRCAm patients. The most common CTCAE grade 3/4 adverse events with cediranib/olaparib remained fatigue, diarrhea, and hypertension.
CONCLUSIONS


Combination cediranib/olaparib significantly extends PFS compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. Subset analyses suggest this margin of benefit is driven by PFS prolongation in patients without gBRCAm. OS was also significantly increased by the cediranib/olaparib combination in this subset of patients. Additional studies of this combination are ongoing and should incorporate analyses based upon BRCA status.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT0111648.",2019,"Subset analyses within stratum defined by BRCA status demonstrated statistically significant improvement in PFS (23.7 versus 5.7 months, P = 0.002) and OS (37.8 versus 23.0 months, P = 0.047) in gBRCA wild-type/unknown patients, although OS was not statistically different in the overall study population (44.2 versus 33.3 months, hazard ratio 0.64; P = 0.11).","['relapsed platinum-sensitive ovarian cancer', 'Participants had relapsed platinum-sensitive ovarian cancer of high-grade serous or endometrioid histology or had a deleterious germline BRCA1/2 mutation (gBRCAm', 'Ninety patients were enrolled to this randomized, open-label, phase II study between October 2011 and June 2013 across nine United States-based academic centers']","['combination cediranib and olaparib versus olaparib', 'olaparib capsules 400\u2009mg twice daily or cediranib 30\u2009mg daily and olaparib capsules 200\u2009mg twice daily until disease progression', 'olaparib alone']","['progression-free survival (PFS', 'OS', 'fatigue, diarrhea, and hypertension', 'overall survival (OS) and update PFS outcomes', 'PFS', 'Overall survival and updated progression-free survival outcomes', 'median PFS', 'PFS and OS']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",90.0,0.168484,"Subset analyses within stratum defined by BRCA status demonstrated statistically significant improvement in PFS (23.7 versus 5.7 months, P = 0.002) and OS (37.8 versus 23.0 months, P = 0.047) in gBRCA wild-type/unknown patients, although OS was not statistically different in the overall study population (44.2 versus 33.3 months, hazard ratio 0.64; P = 0.11).","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': 'Division of Gynecologic Oncology, Department of Medical Oncology. Electronic address: joyce_liu@dfci.harvard.edu.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Birrer', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda.""}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Buckanovich', 'Affiliation': 'Department of Internal Medicine, University of Pittsburgh Hillman Cancer Center, Pittsburgh.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'Section of Hematology/Oncology, University of Chicago, Chicago.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Rimel', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Buss', 'Affiliation': 'Division of Hematology/Oncology, Beth-Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Nattam', 'Affiliation': 'Department of Oncology, Fort Wayne Medical Oncology and Hematology, Fort Wayne.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston Hospital, Evanston.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Division of Gynecologic Oncology, Department of Medical Oncology.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Whalen', 'Affiliation': 'Division of Gynecologic Oncology, Department of Medical Oncology.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda; Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.""}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Ivy', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Division of Gynecologic Oncology, Department of Medical Oncology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz018']
309,30793465,Lower rates of cardiovascular events and mortality associated with liraglutide use in patients treated with basal insulin: A DEVOTE subanalysis (DEVOTE 10).,"AIM


To compare the associations between concomitant liraglutide use versus no liraglutide use and the risk of major adverse cardiovascular events (MACE) and all-cause mortality among patients receiving basal insulin (either insulin degludec [degludec] or insulin glargine 100 units/mL [glargine U100]) in the Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE).
MATERIALS AND METHODS


Patients with type 2 diabetes and high cardiovascular risk were randomized 1:1 to degludec or glargine U100. Hazard ratios for MACE/mortality were calculated using a Cox regression model adjusted for treatment and time-varying liraglutide use at any time during the trial, without interaction. Sensitivity analyses were adjusted for baseline covariates including, but not limited to, age, sex, smoking and prior cardiovascular disease.
RESULTS


At baseline, 436/7637 (5.7%) patients were treated with liraglutide; after baseline, 187/7637 (2.4%) started and 210/7637 (2.7%) stopped liraglutide. Mean liraglutide exposure from randomization was 530.2 days. Liraglutide use versus no liraglutide use was associated with significantly lower hazard rates for MACE [0.62 (0.41; 0.92) 95%CI  ] and all-cause mortality [0.50 (0.29; 0.88) 95%CI  ]. There was no significant difference in the rate of severe hypoglycaemia with versus without liraglutide use. Multiple sensitivity analyses yielded similar results.
CONCLUSIONS


Use of liraglutide was associated with significantly lower risk of MACE and death in patients with type 2 diabetes and high cardiovascular risk using basal insulin.",2019,Liraglutide use versus no liraglutide use was associated with significantly lower hazard rates for MACE [0.62 (0.41; 0.92) 95%CI  ] and all-cause mortality [0.50 (0.29; 0.88) 95%CI  ].,"['patients receiving basal insulin (either insulin degludec [degludec] or', 'Patients with type 2 diabetes and high cardiovascular risk', 'Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE', 'patients with type 2 diabetes and high cardiovascular risk using basal insulin', 'patients treated with basal insulin']","['insulin glargine 100 units/mL [glargine U100', 'Liraglutide', 'liraglutide', 'glargine U100', 'Insulin Degludec versus Insulin Glargine']","['hazard rates', 'risk of MACE and death', 'rate of severe hypoglycaemia', 'cardiovascular events and mortality', 'Hazard ratios for MACE/mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0481126,Liraglutide use versus no liraglutide use was associated with significantly lower hazard rates for MACE [0.62 (0.41; 0.92) 95%CI  ] and all-cause mortality [0.50 (0.29; 0.88) 95%CI  ].,"[{'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Brown-Frandsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Emerson', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, Florida.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mattis F', 'Initials': 'MF', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Grøn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lange', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Moses', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Örsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13677']
310,30689703,Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial.,"BACKGROUND


We report longitudinal health-related quality-of-life (HRQoL) data from the international, randomized, double-blind, placebo-controlled phase III ExteNET study, which demonstrated an invasive disease-free survival benefit of extended adjuvant therapy with neratinib over placebo in human epidermal growth factor receptor-2-positive early-stage breast cancer.
PATIENTS AND METHODS


Women (N  = 2840) with early-stage HER2-positive breast cancer who had completed trastuzumab-based adjuvant therapy were randomly assigned to neratinib 240  mg/day or placebo for 12  months. HRQoL was an exploratory end point. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQol 5-Dimensions (EQ-5D) questionnaires at baseline and months 1, 3, 6, 9, and 12. Changes from baseline were compared using analysis of covariance with no imputation for missing values. Sensitivity analyses used alternative methods. Changes in HRQoL scores were regarded as clinically meaningful if they exceeded previously reported important differences (IDs).
RESULTS


Of the 2840 patients (intention-to-treat population), 2407 patients were evaluable for FACT-B (neratinib, N  = 1171; placebo, N  = 1236) and 2427 patients for EQ-5D (neratinib, N  = 1186; placebo, N  = 1241). Questionnaire completion rates exceeded 85%. Neratinib was associated with a decrease in global HRQoL scores at month 1 compared with placebo (adjusted mean differences: FACT-B total, -2.9 points; EQ-5D index, -0.02), after which between-group differences diminished at later time-points. Except for the FACT-B physical well-being (PWB) subscale at month 1; all between-group differences were less than reported IDs. The FACT-B breast cancer-specific subscale showed small improvements with neratinib at months 3-9, but all were less than IDs. Sensitivity analyses exploring missing data did not change the results.
CONCLUSIONS


Extended adjuvant neratinib was associated with a transient, reversible decrease in HRQoL during the first month of treatment, possibly linked to treatment-related diarrhea. With the exception of the PWB subscale at month 1, all neratinib-related HRQoL changes did not reach clinically meaningful thresholds. ClinicalTrials.gov: NCT00878709.",2019,"Neratinib was associated with a decrease in global HRQoL scores at month 1 compared with placebo (adjusted mean differences: FACT-B total, -2.9 points; EQ-5D index, -0.02), after which between-group differences diminished at later time-points.","['women with HER2-positive early-stage breast cancer', 'human epidermal growth factor receptor-2-positive early-stage breast cancer', 'Women', '2407 patients were evaluable for FACT-B (neratinib, N\u2009\u2009=\u20091171; placebo, N\u2009\u2009=\u20091236) and 2427 patients for EQ-5D (neratinib, N\u2009\u2009=\u20091186; placebo, N\u2009\u2009=\u20091241', '2840 patients (intention-to-treat population', 'N\u2009\u2009=\u20092840) with early-stage HER2-positive breast cancer who had completed trastuzumab-based adjuvant therapy']","['neratinib 240\u2009 mg/day or placebo', 'neratinib over placebo', 'neratinib', 'placebo']","['FACT-B) and EuroQol 5-Dimensions (EQ-5D) questionnaires', 'FACT-B physical well-being (PWB) subscale', 'Questionnaire completion rates', 'HRQoL scores', 'PWB subscale', 'Functional Assessment of Cancer Therapy-Breast', 'global HRQoL scores', 'health-related quality of life', 'HRQoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",2407.0,0.471394,"Neratinib was associated with a decrease in global HRQoL scores at month 1 compared with placebo (adjusted mean differences: FACT-B total, -2.9 points; EQ-5D index, -0.02), after which between-group differences diminished at later time-points.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy, Villejuif, France. Electronic address: suzette.delaloge@gustaveroussy.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine at Northwestern University, Chicago.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Puma Biotechnology Inc, Los Angeles, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-WA & Curtin University, Perth, Australia.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Oncology Research Unit, Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Holmes', 'Affiliation': 'Texas Oncology, P.A, Houston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mansi', 'Affiliation': ""Department of Medical Oncology, Guy's and St Thomas' NHS Foundation Trust and Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center, Chikusa-ku, Nagoya, Japan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Boston, USA.'}, {'ForeName': 'S K L', 'Initials': 'SKL', 'LastName': 'Chia', 'Affiliation': 'Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Smichkoska', 'Affiliation': 'University Clinic for Radiotherapy and Oncology, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ciceniene', 'Affiliation': 'Oncology Institute of Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martinez', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Filipović', 'Affiliation': 'Clinic of Oncology, Clinical Center Niš, Nis, Serbia.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Ben-Baruch', 'Affiliation': 'Department of Oncology, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Cross Cancer Institute, Edmonton, Canada.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Langkjer', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Senecal', 'Affiliation': 'Northwest Medical Specialties PLLC, Tacoma, USA.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'de Boer', 'Affiliation': 'Department of Medical Oncology, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moran', 'Affiliation': 'Puma Biotechnology Inc, Los Angeles, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Puma Biotechnology Inc, Los Angeles, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bryce', 'Affiliation': 'Puma Biotechnology Inc, Los Angeles, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': 'Puma Biotechnology Inc, Los Angeles, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, CIBERONC, GEICAM, Universidad Complutense, Madrid, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz016']
311,30689707,OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer.,"BACKGROUND


In the OlympiAD study, olaparib was shown to improve progression-free survival compared with chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1 and/or BRCA2 mutation (BRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC). We now report the planned final overall survival (OS) results, and describe the most common adverse events (AEs) to better understand olaparib tolerability in this population.
PATIENTS AND METHODS


OlympiAD, a Phase III, randomized, controlled, open-label study (NCT02000622), enrolled patients with a germline BRCAm and HER2-negative mBC who had received ≤2 lines of chemotherapy for mBC. Patients were randomized to olaparib tablets (300 mg bid) or predeclared TPC (capecitabine, vinorelbine, or eribulin). OS and safety were secondary end points.
RESULTS


A total of 205 patients were randomized to olaparib and 97 to TPC. At 64% data maturity, median OS was 19.3 months with olaparib versus 17.1 months with TPC (HR 0.90, 95% CI 0.66-1.23; P = 0.513); median follow-up was 25.3 and 26.3 months, respectively. HR for OS with olaparib versus TPC in prespecified subgroups were: prior chemotherapy for mBC [no (first-line setting): 0.51, 95% CI 0.29-0.90; yes (second/third-line): 1.13, 0.79-1.64]; receptor status (triple negative: 0.93, 0.62-1.43; hormone receptor positive: 0.86, 0.55-1.36); prior platinum (yes: 0.83, 0.49-1.45; no: 0.91, 0.64-1.33). Adverse events during olaparib treatment were generally low grade and manageable by supportive treatment or dose modification. There was a low rate of treatment discontinuation (4.9%), and the risk of developing anemia did not increase with extended olaparib exposure.
CONCLUSIONS


While there was no statistically significant improvement in OS with olaparib compared to TPC, there was the possibility of meaningful OS benefit among patients who had not received chemotherapy for metastatic disease. Olaparib was generally well-tolerated, with no evidence of cumulative toxicity during extended exposure. Please see the article online for additional video content.",2019,"There was a low rate of treatment discontinuation (4.9%), and the risk of developing anemia did not increase with extended olaparib exposure.
","['enrolled patients with a germline BRCAm and HER2-negative mBC who had received ≤2 lines of chemotherapy for mBC', '205 patients', 'patients who had not received chemotherapy for metastatic disease', 'patients with a germline BRCA1 and/or BRCA2 mutation (BRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC', 'patients with a germline BRCA mutation and HER2-negative metastatic breast cancer']","['olaparib and 97 to TPC', 'predeclared TPC (capecitabine, vinorelbine, or eribulin', 'olaparib tablets', 'platinum ']","['meaningful OS benefit', 'Adverse events', 'cumulative toxicity', 'low rate of treatment discontinuation', 'median OS', 'OS and safety', 'risk of developing anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",205.0,0.0720212,"There was a low rate of treatment discontinuation (4.9%), and the risk of developing anemia did not increase with extended olaparib exposure.
","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Robson', 'Affiliation': 'Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York. Electronic address: robsonm@mskcc.org.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Cancer Risk and Prevention Program, Beth Israel Deaconess Medical Center, Department of Medicine, Dana-Farber Harvard Cancer Center, Boston, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Division of Oncology, University of Padova, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'S-A', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Senkus', 'Affiliation': 'Center of Breast Diseases, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Osaka National Hospital, National Hospital Organization, Osaka, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Breast Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Emergency, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Medical Oncology, Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Runswick', 'Affiliation': 'Global Medicines Development, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Department of Medicine, Basser Center, University of Pennsylvania, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz012']
312,30689736,"Major pathologic response on biopsy (MPRbx) in patients with advanced melanoma treated with anti-PD-1: evidence for an early, on-therapy biomarker of response.","BACKGROUND


With increasing anti-PD-1 therapy use in patients with melanoma and other tumor types, there is interest in developing early on-treatment biomarkers that correlate with long-term patient outcome. An understanding of the pathologic features of immune-mediated tumor regression is key in this endeavor.
MATERIALS AND METHODS


Histologic features of immune-related pathologic response (irPR) following anti-PD-1 therapy were identified on hematoxylin and eosin (H&E)-stained slides in a discovery cohort of pre- and on-treatment specimens from n = 16 patients with advanced melanoma. These features were used to generate an irPR score [from 0 = no irPR features to 3 = major pathologic response on biopsy (MPRbx, ≤10% residual viable tumor)]. This scoring system was then tested for an association with objective response by RECIST1.1 and overall survival in a prospectively collected validation cohort of pre- and on-treatment biopsies (n = 51 on-treatment at 4-week timepoint) from melanoma patients enrolled on the nivolumab monotherapy arm of CA209-038 (NCT01621490).
RESULTS


Specimens from responders in the discovery cohort had features of immune-activation (moderate-high TIL densities, plasma cells) and wound-healing/tissue repair (neovascularization, proliferative fibrosis) compared to nonresponders, (P ≤ 0.021, for each feature). In the validation cohort, increasing irPR score associated with objective response (P = 0.009) and MPRbx associated with increased overall survival (n = 51; HR 0.13; 95%CI, 0.054-0.31, P = 0.015). Neither tumoral necrosis nor pretreatment histologic features were associated with response. Eight of 16 (50%) of patients with stable disease showed irPR features, two of which were MPRbx, indicating a disconnect between pathologic and radiographic features at the 4-week on-therapy timepoint for some patients.
CONCLUSIONS


Features of immune-mediated tumor regression on routine H&E-stained biopsy slides from patients with advanced melanoma correlate with objective response to anti-PD-1 and overall survival. An on-therapy biopsy may be particularly clinically useful for informing treatment decisions in patients with radiographic stable disease. This approach is inexpensive, straightforward, and widely available.",2019,"In the validation cohort, increasing irPR score associated with objective response (P = 0.009) and MPRbx associated with increased overall survival (n = 51; HR 0.13; 95%CI, 0.054-0.31, P = 0.015).","['patients with melanoma and other tumor types', 'patients with advanced melanoma treated with anti-PD-1', 'patients with radiographic stable disease', 'Histologic features of immune-related pathologic response (irPR) following anti-PD-1 therapy were identified on hematoxylin and eosin (H&E)-stained slides in a discovery cohort of pre- and on-treatment specimens from n\u2009=\u200916 patients with advanced melanoma']",['biopsy (MPRbx'],"['overall survival', 'irPR features', 'irPR score', 'immune-activation (moderate-high TIL densities, plasma cells) and wound-healing/tissue repair (neovascularization, proliferative fibrosis', 'tumoral necrosis nor pretreatment histologic features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0523207', 'cui_str': 'Hematoxylin and eosin stain method'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032112', 'cui_str': 'Plasma cell'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}]",16.0,0.0723882,"In the validation cohort, increasing irPR score associated with objective response (P = 0.009) and MPRbx associated with increased overall survival (n = 51; HR 0.13; 95%CI, 0.054-0.31, P = 0.015).","[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Stein', 'Affiliation': 'Departments of Dermatology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Departments of Dermatology.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Danilova', 'Affiliation': 'Biostatistics, Johns Hopkins University SOM, Baltimore; The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins, Baltimore.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Cottrell', 'Affiliation': 'Department of Pathology, Johns Hopkins University SOM, Baltimore.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Urba', 'Affiliation': 'Earle A. Chiles Research Institute, Providence Cancer Center, Portland.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Sharfman', 'Affiliation': 'The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins, Baltimore; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University SOM, Baltimore.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Bristol-Myers Squibb, Princeton, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lipson', 'Affiliation': 'The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins, Baltimore; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University SOM, Baltimore.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Taube', 'Affiliation': 'Departments of Dermatology; The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins, Baltimore; Department of Pathology, Johns Hopkins University SOM, Baltimore; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University SOM, Baltimore. Electronic address: jtaube1@jhmi.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz019']
313,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
314,32309876,"The Feasibility, Safety, and Efficacy of the Preemptive Indwelling of Double-J Stents in Percutaneous Nephrolithotomy Surgery: A Randomized Controlled Trial.","PURPOSE


The goal of this study is to compare the feasibility, safety, and efficacy of the preemptive indwelling of double-J stents (PI-DJS) versus the conventional preemptive indwelling of ureteral catheters (PI-UC) in percutaneous nephrolithotomy (PCNL) via a randomized, controlled clinical study.
MATERIALS AND METHODS


A total of 75 patients with complex renal calculi underwent PCNL surgery and were randomized, using random number table, to receive either a PI-DJS (37 cases) or a PI-UC (38 cases). All operations were performed by the same experienced surgeon. Several outcomes were measured, including duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications.
RESULTS


Guided by B-ultrasound, percutaneous passages were successfully established in all patients who then underwent one-stage PCNL. The time required to establish a passage using a PI-DJS was 7.5min, whereas that of the group who received a PI-UC was 11.5min (P < 0.01). There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (all P > 0.05).
CONCLUSION


PI-DJS during PCNL allowed for a reliable and stable reflux from the bladder into the renal pelvis to produce an artificial hydronephrosis without the formation of microbubbles, unlike conventional ureteral catheters.",2020,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","['Percutaneous Nephrolithotomy Surgery', '75 patients with complex renal calculi underwent PCNL surgery']","['Preemptive Indwelling of Double-J Stents', 'conventional preemptive indwelling of ureteral catheters (PI-UC', 'PI-DJS', 'preemptive indwelling of double-J stents (PI-DJS', 'percutaneous nephrolithotomy (PCNL']","['feasibility, safety, and efficacy', 'duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications', 'Feasibility, Safety, and Efficacy', 'operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences']","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",75.0,0.0259171,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","[{'ForeName': 'Fuding', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. bfd0816@hotmail.com.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JiMin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Urology journal,['10.22037/uj.v0i0.4957']
315,32306154,Acute hypertrophic but not maximal strength loading transiently enhances the kynurenine pathway towards kynurenic acid.,"PURPOSE


Due to distinct immuno- and neuro-modulatory properties, growing research interest focuses on exercise-induced alterations of the kynurenine (KYN) pathway in healthy and clinical populations. To date, knowledge about the impact of different acute strength exercise modalities on the KYN pathway is scarce. Therefore, we investigated the acute effects of hypertrophic (HYP) compared to maximal (MAX) strength loadings on the KYN pathway regulation.
METHODS


Blood samples of twelve healthy males (mean age and weight: 23.5 ± 3.2 years; 77.5 ± 7.5 kg) were collected before (T 0 ), immediately after (T 1 ), and 1 h after completion (T 2 ) of HYP (5 sets with 10 repetitions at 80% of 1RM) and MAX (15 sets with 1RM) loadings performed in a randomized cross-over design. Serum concentrations of tryptophan (TRP), KYN, kynurenic acid (KA), and quinolinic acid (QA) were assessed using high-performance liquid chromatography.
RESULTS


The KA/KYN ratio increased from T 0  to T 1  (p = 0.01) and decreased from T 1  to T 2  (p = 0.011) in HYP, while it was maintained within MAX. Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014). Moreover, the QA/KA ratio was significantly lower in HYP than in MAX at T 1  (p = 0.002).
CONCLUSION


Acute HYP loading led to increases in the metabolic flux yielding KA, thereby possibly promoting immunosuppression and neuroprotection. Our findings emphasize the potential of acute HYP exercise as short-term modulator of KYN pathway downstream to KA in healthy males and need to be proven in other samples.",2020,"Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014).","['healthy males', 'healthy and clinical populations', 'Blood samples of twelve healthy males (mean age and weight: 23.5\u2009±\u20093.2\xa0years; 77.5\u2009±\u20097.5\xa0kg']",[],"['KA/KYN ratio', 'serum concentrations of KA', 'QA/KA ratio', 'Serum concentrations of tryptophan (TRP), KYN, kynurenic acid (KA), and quinolinic acid (QA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517859', 'cui_str': '7.5'}]",[],"[{'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034425', 'cui_str': 'Quinolinic Acids'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}]",12.0,0.0225537,"Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014).","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Freitag', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Knoop', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Thevis', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany. philipp.zimmer@tu-dortmund.de.'}]",European journal of applied physiology,['10.1007/s00421-020-04375-9']
316,31834117,Sleep-Wake States and Feeding Progression in Preterm Infants.,"BACKGROUND


Previous studies demonstrated a short-term relationship between infant sleep-wake states and oral feeding performance, with state being an indication of infants' neurobehavioral readiness for feeding. However, the relationship between sleep-wake states and feeding skills has not been evaluated longitudinally during hospitalization.
OBJECTIVES


The purpose of this study was to examine preterm infants' sleep-wake state developmental trajectories and their associations with feeding progression during hospitalization.
METHODS


This descriptive and exploratory study was a secondary analysis using data from a longitudinal two-group, randomized controlled trial evaluating the effects of early and late cycled light on health and developmental outcomes among extremely preterm infants who were born ≤28 weeks of gestational age. Sleep-wake states were assessed for two 2-hour interfeeding periods per day (day and night hours), 30 weeks postmenstrual age, and every 3 weeks until discharge. Occurrences of active sleep, quiet sleep, and waking were recorded every 10 seconds. Feeding progression was assessed based on an infant's postmenstrual age at five milestones: first enteral feeding, full enteral feeding, first oral feeding, half oral feeding, and full oral feeding. Trajectory analyses were used to describe developmental changes in sleep-wake states, feeding progression patterns, and associations between feeding progression and sleep-wake trajectories.
RESULTS


Active sleep decreased while waking, and quiet sleep increased during hospitalization. Two distinct feeding groups were identified: typical and delayed feeding progression. In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression. We also found that infants with delayed feeding progression were more likely to be awake more often during the night compared to infants with typical feeding progression.
DISCUSSIONS


Findings suggest that delays in sleep-wake state development may be associated with delays in feeding progression during hospitalization. Infants with delayed feeding skill development may require more environmental protection to further support their sleep development.",2020,"In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression.","['extremely preterm infants who were born ≤28 weeks of gestational age', 'Preterm Infants', 'preterm infants']",['early and late cycled light'],"['health and developmental outcomes', 'Sleep-wake states', 'Feeding progression', 'Active sleep decreased while waking, and quiet sleep', 'sleep-wake state developmental trajectories', 'Occurrences of active sleep, quiet sleep, and waking', 'sleep-wake states, feeding progression patterns, and associations between feeding progression and sleep-wake trajectories', 'Sleep-Wake States and Feeding Progression', 'rates of active and quiet sleep development']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",,0.0231115,"In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression.","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Jinhee Park, PhD, RN, is Assistant Professor, School of Nursing, Boston College, Chestnut Hill, Massachusetts. Susan G. Silva, PhD, is Associate Professor, School of Nursing, Duke University, Durham, North Carolina. Suzanne M. Thoyre, PhD, RN, FANN, is Professor, School of Nursing, University of North Carolina at Chapel Hill. Debra H. Brandon, PhD, RN, CNS, FAAN, is Associate Professor, School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Thoyre', 'Affiliation': ''}, {'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Brandon', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000395']
317,30821053,Randomised study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Primary results of the BERSON clinical trial.,"AIM


To evaluate the lipid-lowering efficacy and safety of evolocumab combined with background atorvastatin in patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia.
MATERIALS AND METHODS


BERSON was a double-blind, 12-week, phase 3 study (NCT02662569) conducted in 10 countries. Patients ≥18 to ≤80 years with type T2DM received atorvastatin 20 mg/d and were randomised 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or placebo Q2W or QM. Co-primary endpoints were the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures, and adverse events (AEs).
RESULTS


Overall, 981 patients were randomised and received ≥1 dose of study drug. Evolocumab significantly reduced LDL-C versus placebo at week 12 (Q2W, -71.8%; QM, -74.9%) and at the mean of weeks 10 and 12 (Q2W, -70.3%; QM, -70.0%; adjusted P < 0.0001 for all) when administered with atorvastatin. Non-high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol improved significantly with evolocumab versus placebo. The overall incidence of AEs was similar between evolocumab and placebo-treated patients, and there were no clinically meaningful differences in changes over time in glycaemic variables (fasting serum glucose and HbA1c) between the two groups.
CONCLUSIONS


In patients with T2DM and hyperlipidaemia or mixed dyslipidaemia on statin, evolocumab significantly reduced LDL-C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures.",2019,"Evolocumab significantly reduced LDL-C versus placebo at week 12 (Q2W, -71.8%; QM, -74.9%) and at the mean of weeks 10 and 12 (Q2W, -70.3%; QM, -70.0%; adjusted P < 0.0001 for all) when administered with atorvastatin. Non-high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol improved significantly with evolocumab versus placebo.","['patients with T2DM and hyperlipidaemia or mixed dyslipidaemia', 'patients with type 2 diabetes and dyslipidaemia on background statin', '981 patients', 'Patients ≥18 to ≤80\u2009years with type T2DM received', 'patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia', '10 countries']","['evolocumab 140\u2009mg every 2 weeks (Q2W) or 420\u2009mg monthly (QM) or placebo Q2W or QM', 'placebo', 'evolocumab combined with background atorvastatin', 'atorvastatin', 'evolocumab']","['glycaemic variables (fasting serum glucose and HbA1c', 'atherogenic lipids, glycaemic measures, and adverse events (AEs', 'LDL-C and other atherogenic lipids', 'high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol', 'glycaemic measures', 'LDL-C', 'overall incidence of AEs', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0205666', 'cui_str': 'Apo-B-100'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",981.0,0.478183,"Evolocumab significantly reduced LDL-C versus placebo at week 12 (Q2W, -71.8%; QM, -74.9%) and at the mean of weeks 10 and 12 (Q2W, -70.3%; QM, -70.0%; adjusted P < 0.0001 for all) when administered with atorvastatin. Non-high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol improved significantly with evolocumab versus placebo.","[{'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Lorenzatti', 'Affiliation': 'Clinical Research and Cardiology, Instituto Medico DAMIC / Fundación Rusculleda, Córdoba, Argentina.'}, {'ForeName': 'Freddy G', 'Initials': 'FG', 'LastName': 'Eliaschewitz', 'Affiliation': 'CPCLIN - Centro de Pesquisas Clínicas, Rua Goias, São Paulo, Brazil.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Juming', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Baass', 'Affiliation': 'Department of Medicine, Royal Victoria Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Monsalvo', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Hamer', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13680']
318,32202920,"Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial.","We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression. South African adolescents, 13-15 years of age, with mild depressive symptoms, were randomized to intervention or wait-list using parallel assignment in a single-blind trial. HIV risk behavior and depression were evaluated at baseline, 1, and 3 months. We examined intervention satisfaction, fidelity, trial retention, and preliminary efficacy. One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized. All families ranked intervention quality as good or excellent. Over 90% were satisfied with content. Facilitators were adherent to intervention protocol. All families were retained in post-intervention assessments. Intervention recipients reported diminished depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing. Our Family Our Future is highly acceptable and feasible and should be tested in a future efficacy trial.",2020,"We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression.","['South African adolescents, 13-15 years of age, with mild depressive symptoms', 'One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized', 'Adolescent HIV and Depression']",['Resilience-Oriented Family Intervention'],"['depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing', 'HIV risk behavior and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",73.0,0.118718,"We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kuo', 'Affiliation': 'Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Giovenco', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Atujuna', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Beardslee', 'Affiliation': ""Judge Baker Children's Center, Harvard Medical School, and Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoare', 'Affiliation': 'University of Cape Town.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'South African Medical Research Council Unit on Risk & Resilience in Mental Disorders, University of Cape Town.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island, and the Providence/Boston Center for AIDS Research.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.1.67']
319,32107935,A Randomized Controlled Trial of Group Well-Child Care: Improved Attendance and Vaccination Timeliness.,"Well-child care has suboptimal outcomes regarding adherence to appointments and recall of guidance, especially among families facing structural barriers to health. Group well-child care (GWCC) aims to improve these outcomes by enhancing anticipatory guidance discussions and peer education. We conducted a randomized controlled trial, comparing GWCC with traditional, individual well-child care (IWCC) and assessed health care utilization, immunization timeliness, recall of anticipatory guidance, and family-centered care. Ninety-seven mother-infant dyads were randomized to GWCC or IWCC. Compared with IWCC infants, GWCC infants attended more of the 6 preventive health visits (5.41 vs 4.87,  P  < .05) and received more timely immunization at 6 months and 1 year but did not differ in emergency or hospital admission rates. There were no differences in mothers' reports of anticipatory guidance received or family-centered care. As primary care is redesigned for value-based care and structural vulnerabilities are considered, GWCC may be a key option to consider.",2020,"Well-child care has suboptimal outcomes regarding adherence to appointments and recall of guidance, especially among families facing structural barriers to health.",['Ninety-seven mother-infant dyads'],"['IWCC', 'GWCC or IWCC', 'GWCC with traditional, individual well-child care (IWCC']","['emergency or hospital admission rates', '6 preventive health visits']","[{'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0033109', 'cui_str': 'Preventive Health'}]",,0.0649719,"Well-child care has suboptimal outcomes regarding adherence to appointments and recall of guidance, especially among families facing structural barriers to health.","[{'ForeName': 'Ada M', 'Initials': 'AM', 'LastName': 'Fenick', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Leventhal', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilliam', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Marjorie S', 'Initials': 'MS', 'LastName': 'Rosenthal', 'Affiliation': 'Yale University, New Haven, CT, USA.'}]",Clinical pediatrics,['10.1177/0009922820908582']
320,30153737,A Pilot Clinical Trial of Smoking Cessation Services Implemented in the Workplace for Service Industry Employees.,"PURPOSE


Evaluate the feasibility and preliminary efficacy of implementing evidence-based tobacco treatment at the workplace for service industry employees.
DESIGN


Randomized trial using 6 paired worksites (3 test and 3 delayed intervention control sites).
SETTING


US Northeast city.
PARTICIPANTS


Employees were recruited from university food service settings.
INTERVENTION


Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline), and 5 weeks of contingency management that reinforced abstinence or reductions in smoking to encourage progress toward quitting.
MEASURES


Primary measures included a smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites.
ANALYSIS


Analyses compared rates of quit attempts and successful abstinence for at least 24 hours between the test and delayed intervention control sites.
RESULTS


Twenty-five employees were enrolled in treatment. The majority were single (12/25), black (16/25), and reported their educational attainment as high school or less (18/25). Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08). Participants rated the treatment as very helpful overall.
CONCLUSION


Findings support the feasibility and efficacy of providing workplace-based smoking cessation services and may inform strategies to increase access to treatment.",2019,"Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08).","['Employees were recruited from university food service settings', 'Service Industry Employees', 'US Northeast city', '6 paired worksites (3 test and 3 delayed intervention control sites', 'Twenty-five employees were enrolled in treatment']","['implementing evidence-based tobacco treatment', 'Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline']","['rates of quit attempts', 'smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites', 'success quitting', 'rates of quit attempts and successful abstinence']","[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0016490', 'cui_str': 'Food Services'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",25.0,0.021216,"Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08).","[{'ForeName': 'Krysten W', 'Initials': 'KW', 'LastName': 'Bold', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kimmel', 'Affiliation': '2 Being Well at Yale, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Tess H', 'Initials': 'TH', 'LastName': 'Hanrahan', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Romano', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Rojewski', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Fucito', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118795987']
321,32306606,[Efficacy comparison between robot-assisted and laparoscopic surgery for mid-low rectal cancer: a prospective randomized controlled trial].,"Objective:  To compare the short- and long-term outcomes of robot-assisted and laparoscopic radical resection for mid-low rectal cancer.  Methods:  A prospective randomized controlled trial was conducted. A total of 130 patients with mid-low rectal cancer (inclusion criteria: age > 18 or ≤80 years old; pathological diagnosis of rectal adenocarcinoma by colonoscopy; distance from tumor to the anal verge ≤12 cm; no distant metastasis; cT1-3N0-1 or ycT1-3 after neoadjuvant radiotherapy and chemotherapy; suitable for laparoscopic and robotic surgery) at the Department of Colorectal Surgery of the First Affiliated Hospital of Nanchang University from October 2016 to September 2018 were prospectively enrolled. According to computer-generated random number method, patients were randomly divided into the robot group ( n =66) and laparoscopy group ( n =64), and underwent robot-assisted surgery or laparoscopic surgery respectively. Clinicopathological data of all the patients were collected and analyzed. The demographic parameters, short- and long-term outcomes were compared between two groups.  Results:  One patient in robot group whose postoperative sample was diagnosed as rectal adenoma by pathology was excluded. There were no statistically significant differences in age, sex, BMI, ASA classification, distance from tumor to the anal verge, serum CEA level, CA199 level between two groups (all  P >0.05). Operations were successfully performed in all the patients without conversion to open operation. Robotic surgery was found to be associated with less intraoperative blood loss than laparoscopic surgery [(73.4±49.7) ml vs. (119.1±65.7) ml,  t =-4.461,  P <0.001], while there were no statistically significant differences in surgical procedures, operation time, time to first flatus, time to first liquid intake, time to removal of catheter or postoperative hospital stay between two groups (all  P >0.05). Besides, there was no significant difference in the morbidity of postoperative complication between two groups [10.8% (7/65) vs. 12.5 (8/64), χ(2)=4.342,  P =0.720]. The median number of harvested lymph node in the robot group and the laparoscopy group was 15.7±6.2 and 13.8±6.1 ( t =1.724,  P =0.087). There were no significant differences between two groups in tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation (all  P >0.05). The distal resection margin of samples in two groups was all negative. One case in the robot group was found to have positive circumferential resection margin. The median follow up was 24 (9 to 31) months. In the robot group and the laparoscopy group, the 2-year overall survival rate was 95.4% and 90.6% respectively; the 2-year disease-free survival rate was 90.8% and 85.9% respectively, whose differences were not significant (both  P >0.05).  Conclusion:  Robot-assisted radical resection for mid-low rectal cancer can achieve similar short-term and long-term outcomes of laparoscopic resection, while robot-assisted surgery can decrease blood loss during operation, leading to more precise practice in minimally invasive surgery.",2020,"There were no significant differences between two groups in tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation (all  P >0.05).","['mid-low rectal cancer', '130 patients with mid-low rectal cancer (inclusion criteria: age > 18 or ≤80 years old; pathological diagnosis of rectal adenocarcinoma by colonoscopy; distance from tumor to the anal verge ≤12 cm; no distant metastasis; cT1-3N0-1 or ycT1-3 after neoadjuvant radiotherapy and chemotherapy; suitable for laparoscopic and robotic surgery) at the Department of Colorectal Surgery of the First Affiliated Hospital of Nanchang University from October 2016 to September 2018 were prospectively enrolled']","['laparoscopic resection, while robot-assisted surgery', 'laparoscopy', 'Robotic surgery', 'robot-assisted and laparoscopic radical resection', 'Robot-assisted radical resection', 'robot-assisted surgery or laparoscopic surgery respectively', 'robot-assisted and laparoscopic surgery']","['tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation', 'age, sex, BMI, ASA classification, distance from tumor to the anal verge, serum CEA level, CA199 level', 'positive circumferential resection margin', '2-year disease-free survival rate', 'median number of harvested lymph node', 'surgical procedures, operation time, time to first flatus, time to first liquid intake, time to removal of catheter or postoperative hospital stay', '2-year overall survival rate', 'morbidity of postoperative complication', 'intraoperative blood loss', 'blood loss']","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",130.0,0.0311063,"There were no significant differences between two groups in tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation (all  P >0.05).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Q G', 'Initials': 'QG', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'T Y', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20190401-00135']
322,32306608,[Comparison of short-term and long-term efficacy between robot-assisted and thoracoscopy-laparoscopy-assisted radical esophageal cancer surgery].,"Objective:  To explore the safety and short-term and long-term efficacy of robot-assisted radical esophageal cancer surgery.  Methods:  A prospective randomized controlled trial was conducted. Patients who were preoperatively diagnosed as stage 0-IIIB esophageal squamous cell carcinoma and suitable for minimally invasive surgery in our hospital from January 1, 2014 to June 30, 2018 were prospectively enrolled. Those of age ≥75 years having received preoperative neoadjuvant therapy, contradicted to anesthesia or operation due to severe complications, with history of thoracotomy or laparotomy, with concurrent malignant tumors, without complete informations or refusing to participate in this study were excluded. Participants were randomly divided into the thoracoscopy-laparoscopy group and the robot group using a random number table in ratio of 1:1. Preoperative clinicopathological data, surgical data and postoperative outcomes were recorded. The patients were followed up mainly by telephone. Follow-up endpoint was recurrence of esophageal cancer and death. Kaplan-Meier method was used to estimate survival rate. The survival difference between the two groups was analyzed using the log-rank test.  Results:  According to above criteria, a total of 192 esophageal cancer patients were enrolled finally, including 144 males and 48 females with mean age of (61.9±8.6) years. The robot group had 94 cases, including 72 males and 22 females with mean age of (61.3±8.2) years, and the thoracoscopy-laparoscopy group had 98 cases, including 72 males and 26 females with mean age of (62.4±9.1) years. There were no significant differences in baseline data between the two groups (all  P >0.05). Operation was abandoned in one case in each group due to extensive pleural cavity metastasis and one case in each group was converted to thoracotomy. The success rate of operation was 97.9% (92/94) in the robot group and 98.0% (96/98) in the thoracoscopy-laparoscopy group (χ(2)=0.002,  P =0.996). The number of lymph nodes dissected in the robot group was significantly higher than that in the thoracoscopy-laparoscopy group (29.2±12.5 vs. 22.8±13.3,  t =3.433,  P =0.001), while there were no significant differences in operative time, intraoperative blood loss, R0 resection rate, postoperative 30-day mortality, postoperative hospital stay, ICU stay, time to withdrawal of chest drainage tube, ICU readmission, and postoperative morbidity of complications between the two groups (all  P >0.05). The median follow-up time was 21 (3 to 57) months. During the follow-up, 3 cases and 4 cases were lost, and 2 cases and 3 cases died of other diseases in the robot group and in the thoracoscopy-laparoscopy group respectively. Recurrence occurred in 39 cases during follow-up, including 14 recurrences in the robotic group with 1- and 3-year recurrence-free survival rates of 92.4% and 87.6% respectively and the median recurrence time of 15 (9 to 42) months. There were 25 recurrences in the thoracoscopy-laparoscopy group with 1- and 3-year recurrence-free survival rates of 81.7% and 67.9% respectively and the median recurrence time of 9 (3 to 42) months. There was significant difference in recurrence-free survival between the two groups (χ(2)=4.193,  P =0.041).  Conclusions:  The robotic surgical system has good oncology effect and surgical safety in the radical operation of esophageal cancer, which deserves further research and promotion.",2020,There were 25 recurrences in the thoracoscopy-laparoscopy group with 1- and 3-year recurrence-free survival rates of 81.7% and 67.9% respectively and the median recurrence time of 9 (3 to 42) months.,"['192 esophageal cancer patients were enrolled finally, including 144 males and 48 females with mean age of (61.9±8.6) years', 'Patients who were preoperatively diagnosed as stage 0-IIIB esophageal squamous cell carcinoma and suitable for minimally invasive surgery in our hospital from January 1, 2014 to June 30, 2018 were prospectively enrolled', 'Those of age ≥75 years having received preoperative neoadjuvant therapy, contradicted to anesthesia or operation due to severe complications, with history of thoracotomy or laparotomy, with concurrent malignant tumors, without complete informations or refusing to participate in this study were excluded', '72 males and 22 females with mean age of (61.3±8.2) years, and the thoracoscopy-laparoscopy group had 98 cases, including 72 males and 26 females with mean age of (62.4±9.1) years']","['robot-assisted radical esophageal cancer surgery', 'robot-assisted and thoracoscopy-laparoscopy-assisted radical esophageal cancer surgery', 'thoracoscopy-laparoscopy']","['Recurrence', '3-year recurrence-free survival rates', 'survival rate', 'survival difference', 'success rate of operation', 'recurrence of esophageal cancer and death', 'median recurrence time', 'Preoperative clinicopathological data, surgical data and postoperative outcomes', 'operative time, intraoperative blood loss, R0 resection rate, postoperative 30-day mortality, postoperative hospital stay, ICU stay, time to withdrawal of chest drainage tube, ICU readmission, and postoperative morbidity of complications', 'number of lymph nodes', 'recurrence-free survival']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]",192.0,0.0386225,There were 25 recurrences in the thoracoscopy-laparoscopy group with 1- and 3-year recurrence-free survival rates of 81.7% and 67.9% respectively and the median recurrence time of 9 (3 to 42) months.,"[{'ForeName': 'Z F', 'Initials': 'ZF', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Zheng', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'D Y', 'Initials': 'DY', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Wang', 'Affiliation': 'Medical School of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20190327-00120']
323,32314015,Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.,"PURPOSE


This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
METHODS


We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
RESULTS


Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups.
CONCLUSION


Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.",2020,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","['women delivered only by elective cesarean section', '200 women aged ≥\u200918\xa0years who previously delivered by elective CD willing to receive LNG-IUS', 'family planning clinic of Cairo University hospitals from August 2019 to January 2020', 'women undergoing elective cesarean delivery (CD']","['vaginal dinoprostone or placebo', 'Dinoprostone', 'levonorgestrel-releasing intrauterine system insertion', 'vaginal dinoprostone', 'placebo', 'dinoprostone 3\xa0mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion', 'dinoprostone']","['Adverse events', 'Satisfaction score', 'tolerable side effects', 'pain during LNG-IUS insertion', 'pain during insertion and 30\xa0min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects', 'efficacy and safety', 'pain', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1131356', 'cui_str': 'Dinoprostone 3 MG'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",200.0,0.845057,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Faculty of Medicine, Kasr-Alainy, Cairo University, Cairo, Egypt. ahmed.m.rohei@students.kasralainy.edu.eg.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Osman', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05543-0']
324,29923314,"A cholecystokinin B receptor antagonist and cocaine interaction, phase I study.","AIMS


RPR 102681, a cholecystokinin-B antagonist, increased dopamine (DA) release and reduced cocaine self-administration in animals. This pilot study sought to assess the safety and pharmacokinetics (PK) of co-administration of RPR 102681 and cocaine, and to confirm the DA release mechanism of RPR 102681.
METHODS


Sixteen cocaine-dependent participants were randomized to either placebo or RPR102681 at 3 ascending doses; cocaine was co-administered at steady state of RPR 102681. [ 11  C]raclopride positron emission tomography scans were conducted at baseline and at each RPR102681 dose.
RESULTS


RPR 102681 was well tolerated, and safe to co-administer with cocaine. RPR 102681 did not alter the PK of either cocaine or its metabolite benzoylecgonine and showed no intrinsic abuse liability. There was a trend toward reduction of cocaine craving scores. In contrast to animal studies, RPR 102681 significantly increased the binding potential of [ 11  C]raclopride in the ventral striatum (t test, P < .001) and caudate nucleus (t test, P < .0001) in a small subset of patients, suggesting that it may reduce intrasynaptic striatal DA.
CONCLUSION


Overall, this pilot study suggests that RPR 102681 would be unlikely candidate, as an agonist medication for the treatment for cocaine addiction but worth investigating further for possible role in reducing craving.",2019,RPR 102681 did not alter the PK of either cocaine or its metabolite benzoylecgonine and showed no intrinsic abuse liability.,"['Sixteen cocaine-dependent participants', 'animals']","['placebo or RPR102681', 'cocaine', 'RPR 102681 and cocaine']","['cocaine craving scores', 'tolerated, and safe to co-administer with cocaine', 'dopamine (DA) release', 'safety and pharmacokinetics (PK', 'binding potential of [ 11  C]raclopride in the ventral striatum']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0003062', 'cui_str': 'Animals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test (procedure)'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",,0.033038,RPR 102681 did not alter the PK of either cocaine or its metabolite benzoylecgonine and showed no intrinsic abuse liability.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkashef', 'Affiliation': 'Medications Development Division, The National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'James Robert', 'Initials': 'JR', 'LastName': 'Brašić', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Louis R', 'Initials': 'LR', 'LastName': 'Cantelina', 'Affiliation': 'Division of Clinical Pharmacology and Medical Toxicology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Kahn', 'Affiliation': 'Medications Development Division, The National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Chiang', 'Affiliation': 'Medications Development Division, The National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jurij', 'Initials': 'J', 'LastName': 'Mojsiak', 'Affiliation': 'Medications Development Division, The National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Warren', 'Affiliation': 'Department of Psychology, Morgan State University, Baltimore, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Crabb', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Dean F', 'Initials': 'DF', 'LastName': 'Wong', 'Affiliation': 'Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vocci', 'Affiliation': 'Medications Development Division, The National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}]",CNS neuroscience & therapeutics,['10.1111/cns.12994']
325,31984682,"Comparison of symptomatic and functional responses to vagus nerve stimulation in ANTHEM-HF, INOVATE-HF, and NECTAR-HF.","AIMS


Clinical studies of vagal nerve stimulation (VNS) for heart failure with reduced ejection fraction have had mixed results to date. We sought to compare VNS delivery and associated changes in symptoms and function in autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure (ANTHEM-HF), increase of vagal tone in heart failure (INOVATE-HF), and neural cardiac therapy for heart failure (NECTAR-HF) for hypothesis generation.
METHODS AND RESULTS


Descriptive statistics were used to analyse data from the public domain for differences in proportions using Pearson's chi-square test, differences in mean values using Student's unpaired t-test, and differences in changes of mean values using two-sample t-tests. Guideline-directed medical therapy recommendations were similar across studies. Fewer patients were in New York Heart Association 3, and baseline heart rate (HR) was higher in ANTHEM-HF. In INOVATE-HF, VNS was aimed at peripheral neural targets, using closed-loop delivery that required synchronization of VNS to R-wave sensing by an intracardiac lead. Pulse frequency was low (1-2 Hz) because of a timing schedule allowing ≤3 pulses of VNS following at most 25% of detected R waves. NECTAR-HF and ANTHEM-HF used open-loop VNS delivery (i.e. independent of any external signal) aimed at both central and peripheral targets. In NECTAR-HF, VNS delivery at 20 Hz caused off-target effects that limited VNS up-titration in a majority of patients. In ANTHEM-HF, VNS delivery at 10 Hz allowed up-titration until changes in HR dynamics were confirmed. Six months after VNS titration, significant improvements in both HR and HR variability occurred only in ANTHEM-HF. When ANTHEM-HF and NECTAR-HF were compared, greater improvements from baseline were observed in ANTHEM-HF in standard deviation in normal-to-normal R-R intervals (94 ± 26 to 111 ± 50 vs. 146 ± 48 to 130 ± 52 ms; P < 0.001), left ventricular ejection fraction (32 ± 7 to 37 ± 0.4 vs. 31 ± 6 to 33 ± 6; P < 0.05), and Minnesota Living with Heart Failure mean score (40 ± 14 to 21 ± 10 vs. 44 ± 22 to 36 ± 21; P < 0.002). When compared with INOVATE-HF, greater improvement in 6-min walk distance was observed in ANTHEM-HF (287 ± 66 to 346 ± 78 vs. 304 ± 111 to 334 ± 111 m; P < 0.04).
CONCLUSIONS


In this post-hoc analysis, differences in patient demographics were seen and may have caused the differential responses in symptoms and function observed in association with VNS. Major differences in technology platforms, neural targets, VNS delivery, and HR and HR variability responses could have also potentially played a very important role. Further study is underway in a randomized controlled trial with these considerations in mind.",2020,"When ANTHEM-HF and NECTAR-HF were compared, greater improvements from baseline were observed in ANTHEM-HF in standard deviation in normal-to-normal R-R intervals (94 ± 26 to 111 ± 50 vs. 146 ± 48 to 130 ± 52 ms; P < 0.001), left ventricular ejection fraction (32 ± 7 to 37 ± 0.4 vs. 31 ± 6 to 33 ± 6; P < 0.05), and Minnesota Living with Heart Failure mean score (40 ± 14 to 21 ± 10 vs. 44 ± 22 to 36 ± 21; P < 0.002).",['patients with chronic heart failure (ANTHEM-HF'],"['vagal nerve stimulation (VNS', 'autonomic regulation therapy via left or right cervical vagus nerve stimulation']","['left ventricular ejection fraction', 'baseline heart rate (HR', 'HR and HR variability', '6-min walk distance', 'Pulse frequency', 'technology platforms, neural targets, VNS delivery, and HR and HR variability responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0824125,"When ANTHEM-HF and NECTAR-HF were compared, greater improvements from baseline were observed in ANTHEM-HF in standard deviation in normal-to-normal R-R intervals (94 ± 26 to 111 ± 50 vs. 146 ± 48 to 130 ± 52 ms; P < 0.001), left ventricular ejection fraction (32 ± 7 to 37 ± 0.4 vs. 31 ± 6 to 33 ± 6; P < 0.05), and Minnesota Living with Heart Failure mean score (40 ± 14 to 21 ± 10 vs. 44 ± 22 to 36 ± 21; P < 0.002).","[{'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Helmut U', 'Initials': 'HU', 'LastName': 'Klein', 'Affiliation': 'Division of Cardiology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Center for Cardiovascular Research, Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'UCLA Neurocardiology Program of Excellence, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Gregory', 'Affiliation': 'Clinical Cardiovascular Science Foundation, Boston, MA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Massaro', 'Affiliation': 'Department of Biostatistics, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX, USA.'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX, USA.'}, {'ForeName': 'John James E', 'Initials': 'JJE', 'LastName': 'Udelson', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'University of Toronto, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, CA, USA.'}]",ESC heart failure,['10.1002/ehf2.12592']
326,31866092,"Salvage Radiotherapy Versus Hormone Therapy for Prostate-specific Antigen Failure After Radical Prostatectomy: A Randomised, Multicentre, Open-label, Phase 3 Trial (JCOG0401) † .","BACKGROUND


No standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP).
OBJECTIVE


To determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients.
DESIGN, SETTING, AND PARTICIPANTS


This study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was time to treatment failure (TTF) of BCL.
RESULTS AND LIMITATIONS


TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p =  0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions.
CONCLUSIONS


Initial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone.
PATIENT SUMMARY


Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.",2020,"However, clinical relapse-free survival and overall survival did not differ between the arms.","['Prostate-specific Antigen Failure', '210 patients (105 in each arm) were registered, with the median follow-up being 5.5\u2009yr', 'Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy', 'localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP', 'patients with post-RP PSA failure', 'Patients with localised prostate cancer']","['salvage hormone therapy (SHT', 'Salvage Radiotherapy Versus Hormone Therapy', 'bicalutamide [BCL', 'salvage radiation therapy (SRT) ± SHT']","['time to treatment failure (TTF) of BCL', 'SRT treatment failure', 'TTF of BCL', 'clinical relapse-free survival and overall survival', 'erectile dysfunction', 'PSA concentrations']","[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0162643'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",210.0,0.105638,"However, clinical relapse-free survival and overall survival did not differ between the arms.","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yokomizo', 'Affiliation': 'Department of Urology, Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'Department of Urology, National Hospital Organization Shikoku Cancer Centre, Ehime, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Egawa', 'Affiliation': 'Department of Urology, Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Habuchi', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Kawashima', 'Affiliation': 'Department of Urology, Tochigi Cancer Centre, Tochigi, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ishizuka', 'Affiliation': 'Department of Urology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Shinohara', 'Affiliation': 'Department of Renal and Genitourinary Surgery, Hokkaido University Hospital, Hokkaido, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Yoshino', 'Affiliation': 'Department of Urology, Nagoya University School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nihei', 'Affiliation': 'Division of Radiation Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Bunkyo City, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Tobisu', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious disease Centre, Komagome Hospital, Bunkyo City, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Harasanshin Hospital, Fukuoka, Japan. Electronic address: naito@harasanshin.or.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.11.023']
327,32078716,Nomogram predicting cancer-specific mortality in early-onset rectal cancer: a competing risk analysis.,"BACKGROUND


The incidence of rectal cancer has meaningfully increased in young patients. However, quantitative evaluation for the competing data of early-onset rectal cancer is lacking. So, we performed a competing risk analysis to calculate the cumulative incidence of death for patients with early-onset rectal cancer and developed a nomogram to predict the probability of cancer-specific mortality for these patients.
METHODS


We abstracted data of patients with early-onset rectal cancer between 2004 and 2016 by using the Surveillance, Epidemiology, and End Results program database. The cumulative incidence function was used to calculate the crude cancer-specific mortality of early-onset rectal cancer. Fine and Gray's proportional sub-distribution hazard model was adopted to explore the risk factors of cancer-specific death. Then, we establish a nomogram to predict their 3-, 5-, and 10-year probabilities.
RESULTS


We identified 9917 patients with early-onset rectal cancer, and they were randomly divided into training (n = 6941) and validation (n = 2976) cohorts. In the training cohort, the 3-, 5-, and 10-year cumulative incidences of cancer-specific death after diagnosis for early-onset rectal cancer were 11.4%, 19.9%, and 28.8%, respectively. Fine and Gray's model showed that sex, race, marital status, histology, T stage, N stage, M stage, examined lymph nodes, and pretreatment carcinoembryonic antigen were independently associated with cancer-specific mortality. Such factors were selected to develop a prognostic nomogram.
CONCLUSION


The competing risk nomogram has an ideal performance for predictive cancer-specific mortality in early-onset rectal cancer.",2020,The competing risk nomogram has an ideal performance for predictive cancer-specific mortality in early-onset rectal cancer.,"['9917 patients with early-onset rectal cancer', 'young patients', 'patients with early-onset rectal cancer between 2004 and 2016 by using the Surveillance, Epidemiology, and End Results program database', 'patients with early-onset rectal cancer', 'early-onset rectal cancer']",[],"['10-year cumulative incidences of cancer-specific death after diagnosis for early-onset rectal cancer', 'probability of cancer-specific mortality', 'cumulative incidence function', 'crude cancer-specific mortality of early-onset rectal cancer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0031843', 'cui_str': 'function'}]",9917.0,0.100711,The competing risk nomogram has an ideal performance for predictive cancer-specific mortality in early-onset rectal cancer.,"[{'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Clinical Research, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China.""}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Clinical Research, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China.""}, {'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Clinical Research Center, First Affiliated Hospital of Xi'an Jiaotong University, No. 277, Yanta West Road, Xi'an, 710061, Shaanxi, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""School of Public Health, Guangdong Medical University, No. 2, Wenmin East Road, Zhanjiang, 524023, Guangdong, People's Republic of China.""}, {'ForeName': 'Liren', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""School of Public Health, Guangdong Medical University, No. 2, Wenmin East Road, Zhanjiang, 524023, Guangdong, People's Republic of China. fox833@163.com.""}, {'ForeName': 'Jiyu', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Guangdong Medical University, No. 57, South of Renmin Avenue, Zhanjiang, 524001, Guangdong, People's Republic of China. 15812388788@163.com.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': ""Clinical Research Center, First Affiliated Hospital of Xi'an Jiaotong University, No. 277, Yanta West Road, Xi'an, 710061, Shaanxi, People's Republic of China. lujun2006@xjtu.edu.cn.""}]",International journal of colorectal disease,['10.1007/s00384-020-03527-9']
328,32108044,Change in blood eosinophils following treatment with inhaled corticosteroids may predict long-term clinical response in COPD.,"There is an emerging role for blood eosinophil count (EOS) as a biomarker to guide inhaled corticosteroid (ICS) therapy in COPD. Since ICS administration could influence EOS, we hypothesised that change in EOS following treatment with ICS may predict outcomes of long-term therapy.In a  post hoc  analysis of ISOLDE, a 3-year, double-blind trial comparing 500 µg fluticasone propionate twice daily with placebo in 751 patients with moderate-to-severe COPD, we evaluated whether the initial changes in EOS during ICS treatment were predictive of ICS treatment response.EOS change within 1 year after the introduction of ICS was strongly predictive of treatment response. A suppressed EOS was associated with treatment effect. Characteristically, in patients with EOS suppression of ≥200 cells·μL -1 , ICS use was associated with a decelerated rate of decline of forced expiratory volume in 1 s (FEV 1 ), by 32 mL·year -1 , and a 30% reduction in the exacerbation rate. In contrast, in patients experiencing an increase in EOS of ≥200 cells·μL -1 , ICS use was associated with an accelerated rate of decline of FEV 1 , by 37 mL·year -1  and an 80% increase in the exacerbation rate (p<0.0001). EOS change was not predictive of clinical response with regards to health status evaluated using the St George's Respiratory Questionnaire.These findings suggest that EOS change after ICS administration may predict clinical response to ICS therapy in patients with moderate-to-severe COPD at risk of exacerbations. ICS administration may be associated with more frequent exacerbations and an accelerated lung function decline in the 20% of patients in whom EOS increases after the administration of ICS. These hypothesis-generating observations will need validation in prospectively designed studies.The ISOLDE trial was conducted before the ICJME recommended a prospective registration of RCT protocols.",2020,EOS change was not predictive of clinical response with regards to health status evaluated using Saint George Respiratory Questionnaire.,"['patients with moderate-to-severe COPD at risk of exacerbations', '751 patients with moderate-to-severe COPD']","['fluticasone propionate BID with placebo', 'ICS', 'inhaled corticosteroids']","['blood eosinophil count (EOS', 'accelerated lung function decline', 'EOS', 'blood eosinophils', 'exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",751.0,0.238745,EOS change was not predictive of clinical response with regards to health status evaluated using Saint George Respiratory Questionnaire.,"[{'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Mathioudakis', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Bikov', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Foden', 'Affiliation': 'Dept of Medical Statistics, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Lahousse', 'Affiliation': 'Dept of Bioanalysis, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brusselle', 'Affiliation': 'Depts of Epidemiology and Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, UK.'}]",The European respiratory journal,['10.1183/13993003.02119-2019']
329,20826719,"Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation.","Invasive fungal infection (IFI) is a serious threat after allogeneic hematopoietic cell transplant (HCT). This multicenter, randomized, double-blind trial compared fluconazole (N = 295) versus voriconazole (N = 305) for the prevention of IFI in the context of a structured fungal screening program. Patients undergoing myeloablative allogeneic HCT were randomized before HCT to receive study drugs for 100 days, or for 180 days in higher-risk patients. Serum galactomannan was assayed twice weekly for 60 days, then at least weekly until day 100. Positive galactomannan or suggestive signs triggered mandatory evaluation for IFI. The primary endpoint was freedom from IFI or death (fungal-free survival; FFS) at 180 days. Despite trends to fewer IFIs (7.3% vs 11.2%; P = .12), Aspergillus infections (9 vs 17; P = .09), and less frequent empiric antifungal therapy (24.1% vs 30.2%, P = .11) with voriconazole, FFS rates (75% vs 78%; P = .49) at 180 days were similar with fluconazole and voriconazole, respectively. Relapse-free and overall survival and the incidence of severe adverse events were also similar. This study demonstrates that in the context of intensive monitoring and structured empiric antifungal therapy, 6-month FFS and overall survival did not differ in allogeneic HCT recipients given prophylactic fluconazole or voriconazole. This trial was registered at www.clinicaltrials.gov as NCT00075803.",2010,"Despite trends to fewer IFIs (7.3% vs 11.2%; P = .12), Aspergillus infections (9 vs 17; P = .09), and less frequent empiric antifungal therapy (24.1% vs 30.2%, P = .11) with voriconazole, FFS rates (75% vs 78%; P = .49) at 180 days were similar with fluconazole and voriconazole, respectively.","['allogeneic hematopoietic cell transplant (HCT', 'invasive fungal infection after allogeneic hematopoietic cell transplantation', 'Patients undergoing myeloablative allogeneic HCT']","['Positive galactomannan', 'fluconazole', 'HCT', 'fluconazole or voriconazole', 'voriconazole', 'Serum galactomannan']","['Aspergillus infections', 'Relapse-free and overall survival and the incidence of severe adverse events', 'FFS rates', 'freedom from IFI or death (fungal-free survival; FFS', '6-month FFS and overall survival', 'frequent empiric antifungal therapy']","[{'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0060961', 'cui_str': 'galactomannan'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}]",305.0,0.661423,"Despite trends to fewer IFIs (7.3% vs 11.2%; P = .12), Aspergillus infections (9 vs 17; P = .09), and less frequent empiric antifungal therapy (24.1% vs 30.2%, P = .11) with voriconazole, FFS rates (75% vs 78%; P = .49) at 180 days were similar with fluconazole and voriconazole, respectively.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'University of Florida, Gainesville, FL, USA. wingajr@medicine.ufl.edu'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': ''}, {'ForeName': 'Trudy N', 'Initials': 'TN', 'LastName': 'Small', 'Affiliation': ''}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ''}, {'ForeName': 'Iris D', 'Initials': 'ID', 'LastName': 'Gersten', 'Affiliation': ''}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Mendizabal', 'Affiliation': ''}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Leather', 'Affiliation': ''}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Confer', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': ''}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': ''}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dipersio', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': ''}, {'ForeName': 'Kieren A', 'Initials': 'KA', 'LastName': 'Marr', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,['10.1182/blood-2010-02-268151']
330,23943184,Comparative cost-effectiveness analysis of voriconazole and fluconazole for prevention of invasive fungal infection in patients receiving allogeneic hematopoietic cell transplants.,"PURPOSE


The cost-effectiveness of voriconazole versus fluconazole prophylaxis against fungal infections in hematopoietic cell transplant (HCT) recipients is investigated.
METHODS


A decision-analytic model was developed to estimate the drug costs associated with planned or supplemental prophylaxis and empirical therapy and the costs of treating suspected or documented invasive fungal infections (IFIs) in HCT recipients. Published clinical trial data on 599 patients who received 100-180 days of prophylactic therapy with voriconazole or fluconazole were used to model specified IFI-prevention and mortality outcomes; 6-month, 12-month, and lifetime incremental cost-effectiveness ratios (ICERs) were estimated, with a bootstrap analysis performed to reffect the uncertainty of the clinical trial data.
RESULTS


Estimated mean total prophylaxis and IFI-related costs associated with voriconazole versus fluconazole prophylaxis over 12 months were higher in the entire study population and among patients receiving HCT for diagnoses other than acute myeloid leukemia (AML) but were not significantly different for patients with AML. The cost per IFI avoided ($66,919) and the cost per life-year gained ($5,453) were lower among patients with AML who received voriconazole relative to the full study population. ICERs were more favorable for voriconazole over a 6-month time frame and when modeling was conducted using generic price data. Assuming a threshold value of $50,000 for one year of life gained, the calculated probability of voriconazole being cost-effective was 33% for the full study population and 85% for the AML subgroup.
CONCLUSION


The decision model indicated that voriconazole prophylaxis was cost-effective for patients undergoing allogeneic HCT for AML.",2013,ICERs were more favorable for voriconazole over a 6-month time frame and when modeling was conducted using generic price data.,"['599 patients who received 100-180 days of prophylactic therapy with', 'hematopoietic cell transplant (HCT) recipients', 'patients receiving allogeneic hematopoietic cell transplants']","['voriconazole', 'voriconazole prophylaxis', 'HCT', 'voriconazole and fluconazole', 'fluconazole prophylaxis', 'voriconazole or fluconazole']","['Estimated mean total prophylaxis and IFI-related costs', 'ICERs', 'lifetime incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",599.0,0.0255454,ICERs were more favorable for voriconazole over a 6-month time frame and when modeling was conducted using generic price data.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mauskopf', 'Affiliation': 'Health Economics, RTI Health Solutions, Research Triangle Park, NC 12194, USA. jmauskopf@rti.org'}, {'ForeName': 'Costel', 'Initials': 'C', 'LastName': 'Chirila', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Iris D', 'Initials': 'ID', 'LastName': 'Gersten', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Leather', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': ''}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': ''}, {'ForeName': 'Janice M Y', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': ''}, {'ForeName': 'Kieren A', 'Initials': 'KA', 'LastName': 'Marr', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': ''}]",American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,['10.2146/ajhp120599']
331,32305492,Probiotics and fructo-oligosaccharide intervention modulate the microbiota-gut brain axis to improve autism spectrum reducing also the hyper-serotonergic state and the dopamine metabolism disorder.,"The prevalence of autism spectrum disorders (ASD) is increasing, but its etiology remains elusive and hence an effective treatment is not available. Previous research conducted on animal models suggests that microbiota-gut-brain axis may contribute to ASD pathology and more human research is needed. This study was divided into two stages,.At the discovery stage, we compared the differences in gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters (using UHPLC-MS/MS) of 26 children with ASD and 24 normal children. All 26 children with ASD participated in the intervention stage, and we measured the gut microbiota profiles, SCFAs and neurotransmitters before and after probiotics + FOS (n = 16) or placebo supplementation (n = 10). We found that gut microbiota was in a state of dysbiosis and significantly lower levels of Bifidobacteriales and Bifidobacterium longum were observed at the discovery stage in children with ASD. An increase in beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium) emerged after probiotics + FOS intervention, with significant reduction in the severity of autism and gastrointestinal symptoms. Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD. Interestingly, the above SCFAs in children with autism significantly elevated after probiotics + FOS intervention and approached those in the control group. In addition, our data demonstrated that decreased serotonin and increased homovanillic acid emerged after probiotics + FOS intervention. However, the above-mentioned changes did not appear in the placebo group for ASD children. Probiotics + FOS intervention can modulate gut microbiota, SCFAs and serotonin in association with improved ASD symptoms, including a hyper-serotonergic state and dopamine metabolism disorder.",2020,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","['26 children with ASD', '26 children with ASD and 24 normal children', 'autism', 'autism spectrum disorders (ASD', 'children with ASD']","['Probiotics and fructo-oligosaccharide intervention', 'placebo supplementation', 'Probiotics\u2009+\u2009FOS intervention', 'placebo']","['gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters', 'hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid', 'severity of autism and gastrointestinal symptoms', 'acetic acid, propionic acid and butyric acid', 'homovanillic acid', 'beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0024868', 'cui_str': 'Chromatography, Gas-Mass Spectrometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1037103', 'cui_str': 'Bifidobacteriales'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",26.0,0.0229384,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China; State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: wangyingying67@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 754520623@qq.com.""}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'College of Life Science, Qilu Normal University, Jinan, Shandong, China. Electronic address: microbiota@foxmail.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhao', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: jnzhaodongmei@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China. Electronic address: binchen23@163.com.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Zhang', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: gqzhang@picb.ac.cn.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China; CAS Key Laboratory of Quantitative Engineering Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China. Electronic address: shuo.chen1@siat.ac.cn.'}, {'ForeName': 'Rui-Fang', 'Initials': 'RF', 'LastName': 'Cao', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: caoruifang@picb.ac.cn.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: yuhan_1991@163.com.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1163310981@qq.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1295163749@qq.com.""}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1305358934@qq.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: liuyi-ly@126.com.""}, {'ForeName': 'Le-Hai', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zlh6813@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: hw_1@sdu.edu.cn.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China; Microbiome Research Center, Shandong Institutes for Food and Drug Control, Shandong Institute of Industrial Technology for Health Sciences and Precision Medicine, Jinan, Shandong, China. Electronic address: microbiome@foxmail.com.""}, {'ForeName': 'Zhong-Tao', 'Initials': 'ZT', 'LastName': 'Gai', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: gzt@etyy.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.104784']
332,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma.
METHODS


It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months.
RESULTS


In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months.
CONCLUSION


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
333,32034490,Efficacy of screening using annual fecal immunochemical test alone versus combined with one-time colonoscopy in reducing colorectal cancer mortality: the Akita Japan population-based colonoscopy screening trial (Akita pop-colon trial).,"PURPOSE


Screening programs using fecal occult blood testing help reduce mortality from colorectal cancer (CRC). Colonoscopy and colonoscopy combined with fecal occult blood testing are considered alternatives with higher sensitivity than fecal tests; however, to our knowledge, randomized controlled trials (RCTs) providing such evidence have not been reported. Therefore, this study aimed to compare screening using the fecal immunochemical test (FIT) combined with colonoscopy and FIT alone to evaluate the efficacy of colonoscopy screening in reducing CRC mortality.
METHODS


This multicenter, prospective, randomized, controlled study included average-risk individuals for CRC living in the study areas and aged 40-74 years. The exclusion criteria were history of CRC, hereditary non-polyposis CRC, familial adenomatous polyposis, inflammatory bowel diseases, history of cancer other than CRC within the past 5 years, and not expected to survive from comorbid illness. The intervention group underwent one-time colonoscopy and annual FIT, while the control group underwent annual FIT. The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events. The intervention and control groups comprised 4876 and 4875 participants, respectively.
CONCLUSION


This explanatory RCT evaluated the efficacy of colonoscopy screening by valid statistical inference based on randomization. Data on adverse events from this kind of screening are necessary when considering implementation of future screening programs.
TRIAL REGISTRATION


UMIN Clinical Trials Registry, number UMIN000001980.",2020,"The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events.","['average-risk individuals for CRC living in the study areas and aged 40-74\xa0years', 'colorectal cancer (CRC']","['colonoscopy screening', 'one-time colonoscopy and annual FIT, while the control group underwent annual FIT', 'fecal immunochemical test (FIT) combined with colonoscopy and FIT alone', 'Colonoscopy and colonoscopy combined with fecal occult blood testing', 'screening using annual fecal immunochemical test alone versus combined with one-time colonoscopy']","['mortality from CRC', 'colorectal cancer mortality', 'cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.101365,"The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events.","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Aomori Prefectural Central Hospital, 2-1-1 Higashi-Tsukurimichi, Aomori, 030-8553, Japan. hrsaito@med.pref.aomori.jp.'}, {'ForeName': 'Shin-Ei', 'Initials': 'SE', 'LastName': 'Kudo', 'Affiliation': 'Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Division of Screening Assessment and Management, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Kodama', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Fukushima Hospital, Fukushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Cancer Screening Center, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Mizota', 'Affiliation': 'Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Ishida', 'Affiliation': 'Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-020-03518-w']
334,32310162,Brain Perfusion Change in Patients with Mild Cognitive Impairment After 12 Months of Aerobic Exercise Training.,"Aerobic exercise (AE) has recently received increasing attention in the prevention of Alzheimer's disease (AD). There is some evidence that it can improve neurocognitive function in elderly individuals. However, the mechanism of these improvements is not completely understood. In this prospective clinical trial, thirty amnestic mild cognitive impairment participants were enrolled into two groups and underwent 12 months of intervention. One group (n = 15) performed AE training (8M/7F, age = 66.4 years), whereas the other (n = 15) performed stretch training (8M/7F, age = 66.1 years) as a control intervention. Both groups performed 25-30 minutes training, 3 times per week. Frequency and duration were gradually increased over time. Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004). Cerebral blood flow (CBF) was measured at pre- and post-training using pseudo-continuous-arterial-spin-labeling MRI. Relative to the stretch group, the AE group displayed a training-related increase in CBF in the anterior cingulate cortex (p = 0.016). Furthermore, across individuals, the extent of memory improvement was associated with CBF increases in anterior cingulate cortex and adjacent prefrontal cortex (voxel-wise p < 0.05). In contrast, AE resulted in a decrease in CBF of the posterior cingulate cortex, when compared to the stretch group (p = 0.01). These results suggest that salutary effects of AE in AD may be mediated by redistribution of blood flow and neural activity in AD-sensitive regions of brain.",2020,Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004).,"['Patients with Mild Cognitive Impairment', 'thirty amnestic mild cognitive impairment participants', 'elderly individuals']","['Aerobic Exercise Training', 'AE training', 'Aerobic exercise (AE', 'stretch training (8M/7F, age\u200a=\u200a66.1 years) as a control intervention']","['Cerebral blood flow (CBF', 'blood flow and neural activity', 'CBF', 'memory function', 'CBF increases in anterior cingulate cortex and adjacent prefrontal cortex', 'CBF of the posterior cingulate cortex', 'neurocognitive function', 'cardiorespiratory fitness', 'Frequency and duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",30.0,0.0166923,Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004).,"[{'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Sheng', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tseng', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rypma', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190977']
335,32310169,"A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer's Disease.","BACKGROUND


Alzheimer's disease (AD) is characterized by amyloid-β plaques, neurofibrillary tangles, and regional cerebral glucose hypometabolism. Providing an alternative metabolic substrate, such as ketone bodies, may be a viable therapeutic option.
OBJECTIVE


The objective was to determine the efficacy and safety of the AC-1204 formulation of caprylic triglyceride administered daily for 26 weeks in APOE4 non-carrier participants with mild-to-moderate AD.
METHODS


In a double-blind, placebo-controlled, randomized study (AC-12-010, NOURISH AD, NCT01741194), 413 patients with mild-to-moderate probable AD were stratified by APOE genotype and randomized (1 : 1) to receive either placebo or AC-1204 for 26 weeks. The primary outcome was the change from baseline to week 26 on the 11-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11) among APOE4 non-carriers. The key secondary outcome was the change from baseline to week 26 in the Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change scale.
RESULTS


Administration of AC-1204 was safe and well-tolerated. Mean changes from baseline in the primary outcome at 26 weeks in ADAS-Cog11 for placebo (n = 138) was 0.0 and for AC-1204 (n = 137) was 0.6 (LS differences of mean - 0.761, p = 0.2458) and secondary outcome measures failed to detect any drug effects.
CONCLUSION


The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD. The lack of efficacy observed in this study may have several contributing factors including a lower ketone body formation from AC-1204 than expected and a lack of decline in the patients receiving placebo.",2020,The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD.,"['413 patients with mild-to-moderate probable AD were stratified by APOE genotype and randomized ', ""Mild-to-Moderate Alzheimer's Disease"", 'subjects with mild-to-moderate AD', '26 weeks in APOE4 non-carrier participants with mild-to-moderate AD']","['placebo or AC-1204', 'placebo', 'AC-1204', 'caprylic triglyceride', 'Placebo']","['efficacy and safety', 'cognition or functional ability', ""11-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11"", ""Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change scale"", 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077030', 'cui_str': 'tricaprylin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",413.0,0.511938,The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD.,"[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Henderson', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Morimoto', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': 'Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas (UNLV), Las Vegas, NV, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Farlow', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191302']
336,32310196,Upper limb recovery in early acute phase stroke survivors by coupled EMG-triggered and cyclic neuromuscular electrical stimulation.,"BACKGROUND


Few patients with severe upper extremity (UE) paresis after stroke achieved full recovery, because of the lack of a definitive approach to improve severe UE paresis immediately after onset.
OBJECTIVE


to investigate the effects of coupled EMG-triggered and cyclic neuromuscular electrical stimulation (NMES) on UE paresis during early acute phase of stroke.
METHODS


Seventeen participants with severe UE disability met the criteria. 8 subjects received 20 minutes of NMES prior to standard care per session, while 9 age- and severity-matched subjects received two times 20 minutes of standard care. Outcome measures included UE motor section of the Fugl-Meyer Motor Assessment Scale (FMA-UE), Wolf motor function test (WMFT), and box and block test (BBT).
RESULTS


The NMES group received treatment (average session: 10.87) after a median 7 days from stroke (16.5 sessions after 5 days for control). To adjust the different treatment durations, we defined ""progress rate"" as the gains of UE function scores divided by treatment duration. The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
CONCLUSIONS


The present study suggested beneficial effects of coupled NMES on UE paresis during early acute phase of stroke.",2020,"The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
","['Seventeen participants with severe UE disability met the criteria', 'UE paresis during early acute phase of stroke']","['NMES', 'coupled EMG-triggered and cyclic neuromuscular electrical stimulation (NMES', 'coupled NMES']","['UE motor section of the Fugl-Meyer Motor Assessment Scale (FMA-UE), Wolf motor function test (WMFT), and box and block test (BBT', 'progress rate']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",17.0,0.0424184,"The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Obayashi', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Onuki', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}]",NeuroRehabilitation,['10.3233/NRE-203024']
337,32310197,Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial.,"BACKGROUND


Exercise training has positive effects on motor and cognitive performance which deteriorates over time in patients with Multiple Sclerosis (MS). The effects of task-oriented circuit training (TOCT) on motor and cognitive performance in patients with MS are not yet clear.
OBJECTIVE


The aims of this study are to investigate the effects of TOCT on balance, walking, manual dexterity, cognitive performance, and to determine the extent to which patients are able to transfer changes in their performance to activities of daily living.
METHODS


Twenty patients with MS (EDSS: 2-5.5), were randomly assigned to two groups; the task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10). The TOCTG received TOCT twice a week for six weeks while the CG performed the relaxation exercises at home. All patients were assessed by using Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire.
RESULTS


Balance and walking performance were improved after TOCT (p < 0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p > 0.05). The CG showed no changes in any measurements (p > 0.05).
CONCLUSIONS


TOCT is quite effective to improve balance and walking in patients with MS. However, further studies are needed to determine the effect of TOCT on cognitive performance.",2020,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","['Twenty patients with MS (EDSS: 2-5.5', 'patients with MS', 'patients with Multiple Sclerosis (MS', 'patients with multiple sclerosis']","['Exercise training', 'TOCT', 'task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10', 'task-oriented circuit training (TOCT', 'task-oriented circuit training']","['Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire', 'motor and cognitive performance', 'Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item', 'manual dexterity and cognitive performance except for verbal memory', 'balance, walking, manual dexterity, cognitive performance', 'Balance and walking performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",20.0,0.0146737,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",NeuroRehabilitation,['10.3233/NRE-203029']
338,32020400,"Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial.","OBJECTIVES


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


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


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


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


• Patients treated with MWA plus chemotherapy had superior PFS and OS over those treated with chemotherapy alone. • The ORR of patients treated with MWA plus chemotherapy was similar to that of those treated with chemotherapy alone. • Complications associated with MWA were common but tolerable and manageable.",2020,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","['From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC', 'One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group', 'advanced non-small cell lung cancer', 'A total of 293 patients', 'One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group']","['chemotherapy', 'MWA plus chemotherapy group or chemotherapy', 'microwave ablation (MWA', 'Microwave ablation plus chemotherapy versus chemotherapy', 'MWA plus chemotherapy']","['overall survival (OS), time to local progression (TTLP), and objective response rate (ORR', 'progression-free survival (PFS', 'median TTLP', 'Median PFS', 'complications and adverse events', 'superior PFS and OS', 'Median OS', 'adverse event rate', 'ORR']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",293.0,0.295302,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. yexintaian2014@163.com.'}, {'ForeName': 'Qingliang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Licheng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Wenqiao', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Chuntang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Guangxu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Kaixian', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Peishun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Jingwang', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Shaoshui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Dianzhong', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Benhua', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Liangming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Dengjun', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Xinglu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Cunqi', 'Initials': 'C', 'LastName': 'Diao', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Meng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ""Public Health School, Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Zhigeng', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}]",European radiology,['10.1007/s00330-019-06613-x']
339,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


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


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


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


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
340,32305222,Prognostic Usefulness of Myocardial Work in Patients With Heart Failure and Reduced Ejection Fraction Treated by Sacubitril/Valsartan.,"The noninvasive assessment of myocardial work (MW) by pressure-strain loops analysis (PSL) is a relative new tool for the evaluation of myocardial performance. Sacubitril/Valsartan is a treatment for heart failure with reduced ejection fraction (HFrEF) which has a spectacular effect on the reduction of cardiovascular events (major adverse cardiovascular events [MACEs]). This study aimed to evaluate the short- and medium-term effect of Sacubitril/Valsartan treatment on MW parameters and the prognostic value of MW in this specific group of patients. Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with Sacubitril/Valsartan. Echocardiographic examination was performed at baseline, and after 6- and 12-month of therapy with Sacubitril/Valsartan. Sacubitril/Valsartan significantly increased myocardial constructive work (CW) (1023 ± 449 vs 1424 ± 484 mm Hg%, p <0.0001) and myocardial work efficiency (WE) [87 (78to 90) vs 90 (86 to 95), p <0.0001]. During FU (2.6 ± 0.9 years), MACEs occurred in 13 (16%) patients. After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04]. A CW <910 mm Hg identified patients at particularly increase risk of MACEs [HR 11.09 (1.45 to 98.94), p = 0.002, log-rank test p <0.0001]. In conclusion, in patients with HFrEF who receive a comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy, Sacubitril/Valsartan induces a significant improvement of myocardial CW and WE. In this population, the estimation of CW before the initiation of Sacubitril/Valsartan allows the prediction of MACEs.",2020,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","['patients', 'Patients With Heart Failure and Reduced Ejection Fraction Treated by', 'Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with', 'patients with HFrEF who receive a']","['pressure-strain loops analysis (PSL', 'Sacubitril/Valsartan', 'comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy']","['myocardial CW and WE', 'Echocardiographic examination', 'MACEs', 'myocardial constructive work (CW', 'myocardial work efficiency', 'LV size, LV ejection fraction and WE, global myocardial constructive work (CW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",79.0,0.0223874,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","[{'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Bouali', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Gallard', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Laurin', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Hubert', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Auriane', 'Initials': 'A', 'LastName': 'Bidaut', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Galli', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France. Electronic address: elena.galli@chu-rennes.fr.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.031']
341,32305223,Characteristics and Outcome of Patients ≥75 Years of Age With Prior Coronary Artery Bypass Grafting Admitted for an Acute Coronary Syndrome.,"The prognostic role of previous coronary artery bypass (CABG) in elderly patients admitted to hospital for an acute coronary syndrome (ACS) is unclear. Therefore, the aim of this study was to compare the prognosis of patients aged ≥75 years admitted for an ACS with or without previous history of CABG. The primary outcome of the study was a composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up. We included 2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial) - 178 (7.9%) with previous CABG, 2,075 (92.1%) without. Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission. However, both at univariate analysis and after adjustment for the most relevant covariates (sex, age, previous myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission), previous CABG did not show any statistically significant association with 1-year outcome (adjusted hazard ratio 0.85; 95% confidence interval 0.61 to 1.19; p = 0.353). In conclusion, our study suggests that elderly ACS patients with previous CABG have worse basal clinical characteristics. Nevertheless, in a broad cohort of patients mostly treated with percutaneous coronary intervention during the index event, previous CABG did not confer independent additional risk of major adverse cardiovascular events at 1-year follow-up.",2020,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","['Patients ≥75 Years of Age', 'patients aged ≥75 years admitted for an ACS with or without previous history of CABG', '2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial', 'elderly ACS patients with previous CABG', 'elderly patients admitted to hospital for an acute coronary syndrome (ACS']","['percutaneous coronary intervention', 'coronary artery bypass (CABG']","['composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up', 'cardiovascular risk factors, lower ejection fraction', 'myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]",2253.0,0.0523231,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","[{'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy. Electronic address: nuccia.morici@ospedaleniguarda.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Rosa', 'Affiliation': 'Cardiology Unit, Cardiovascular and Thoracic Department, University Hospital ""San Giovanni di Dio e Ruggi d\'Aragona"", Salerno, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Crimi', 'Affiliation': 'Interventional Cardiology Unit, Cardio Thoraco Vascular Department, IRCCS Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'De Luca', 'Affiliation': 'Division of Cardiology, S. Giovanni Evangelista Hospital, Rome, Italy.'}, {'ForeName': 'Luca A', 'Initials': 'LA', 'LastName': 'Ferri', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Piatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tortorella', 'Affiliation': 'Division of Cardiology, Ospedale Vaio, Fidenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Grosseto', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bossi', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Montalto', 'Affiliation': 'Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': 'Center of Clinical Pathology and Innovative Therapy, Italian National Research Center on Aging (IRCCS INRCA), Ancona, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Alicandro', 'Affiliation': 'Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Cardiovascular Department, Ospedale ""Maggiore della Carità"", Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Servi', 'Affiliation': 'University of Pavia, Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.021']
342,32244111,Glucocorticoids and cortical decoding in the phobic brain.,"Glucocorticoids reduce phobic fear in anxiety disorders and enhance psychotherapy, possibly by reducing the retrieval of fear memories and enhancing the consolidation of new corrective memories. Glucocorticoid signaling in the basolateral amygdala can influence connected fear and memory-related cortical regions, but this is not fully understood. Previous studies investigated specific pathways moderated by glucocorticoids, for example, visual-temporal pathways; however, these analyses were limited to a-priori selected regions. Here, we performed whole-brain pattern analysis to localize phobic stimulus decoding related to the fear-reducing effect of glucocorticoids. We reanalyzed functional magnetic resonance imaging (fMRI) data from a previously published study with spider-phobic patients and healthy controls. The patients received glucocorticoids or a placebo before the exposure to spider images. There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls. Decoding in the ACC and the right insula showed strong evidence for correlation with experienced fear. Patients with cortisol reported a reduction of fear by 10-13%; however, there was only weak evidence for changes in neural decoding compared to placebo which was found in the precuneus, the opercular cortex, and the left cerebellum.",2020,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,['spider-phobic patients and healthy controls'],"['placebo', 'glucocorticoids', 'Glucocorticoids', 'glucocorticoids or a placebo', 'functional magnetic resonance imaging (fMRI']","['neural decoding', 'reduction of fear']","[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0236284,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schwab', 'Affiliation': 'Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, United Kingdom; Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland. Electronic address: simon.schwab@uzh.ch.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Federspiel', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland; Japan Science and Technology Agency, PRESTO, Saitama, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Nakataki', 'Affiliation': 'Department of Psychiatry, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strik', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Dept. of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Quervain', 'Affiliation': 'Division of Cognitive Neuroscience, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Leila M', 'Initials': 'LM', 'LastName': 'Soravia', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111066']
343,32249446,"Periodontal regeneration versus extraction and dental implant or prosthetic replacement of teeth severely compromised by attachment loss to the apex: A randomized controlled clinical trial reporting 10-year outcomes, survival analysis and mean cumulative cost of recurrence.","BACKGROUND


Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intra-bony defects. The aim of this study was to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient-reported and economic outcomes.
METHODS


This was a 10-year randomized controlled clinical trial. 50 stage III or stage IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant- or a tooth-supported fixed partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly. Survival and recurrence analysis were performed.
RESULTS


88% and 100% survival rates were observed in the PR and TER groups. Complication-free survival was not significantly different: 6.7-9.1 years for PR and 7.3-9.1 years for TER (p = .788). In PR, the observed 10-year attachment gain was 7.3 ± 2.3 mm and the residual probing depths were 3.4 ± 0.8 mm. Recurrence analysis showed that the 95% confidence interval of the costs was significantly lower for PR compared with TER throughout the whole 10-year period. Patient-reported outcomes and oral health-related quality-of-life measurements improved in both groups.
CONCLUSIONS


Periodontal regeneration can change the prognosis of hopeless teeth and is a less costly alternative to tooth extraction and replacement. The complexity of the treatment limits widespread application to the most complex cases but provides powerful proof of principle for the benefits of PR in deep intra-bony defect.",2020,Recurrence analysis showed that the 95% confidence interval of the costs was significantly lower for PR compared to TER throughout the whole 10-year period.,['50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex'],"['Periodontal regeneration versus extraction and dental implant or prosthetic replacement', 'tooth extraction and replacement (TER', 'PR or TER with either an implant or a tooth supported fixed partial denture']","['survival rates', 'oral health related quality of life measurements', 'Complication free survival', 'periodontal regeneration (PR', '10-year attachment gain', 'survival analysis and mean cumulative cost of recurrence', 'Survival and recurrence analysis']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0227089', 'cui_str': 'Structure of deciduous maxillary right second molar tooth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.167162,Recurrence analysis showed that the 95% confidence interval of the costs was significantly lower for PR compared to TER throughout the whole 10-year period.,"[{'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Cortellini', 'Affiliation': 'Accademia Toscana di Ricerca Odontostomatologia (ATRO), Florence, Italy.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stalpers', 'Affiliation': 'Private Practice, Florence, Italy.'}, {'ForeName': 'Aniello', 'Initials': 'A', 'LastName': 'Mollo', 'Affiliation': 'Private Practice, Florence, Italy.'}, {'ForeName': 'Maurizio S', 'Initials': 'MS', 'LastName': 'Tonetti', 'Affiliation': 'European Research Group on Periodontology (ERGOPERIO), Genova, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13289']
344,31945659,Influence of infiltration anaesthesia on perioperative outcomes following lumbar discectomy under surgical pleth index-guided general anaesthesia: A preliminary report from a randomised controlled prospective trial.,"PURPOSE


Severe postoperative pain (SPP) may occur after lumbar discectomy. To prevent SPP and reduce rescue opioid consumption, infiltration anaesthesia (IA) has been combined with general anaesthesia (GA). This study verified how GA combined with IA facilitated intra- and postoperative demand for opioids and affected the incidence of SPP in patients subjected to open lumbar discectomy.
MATERIALS/METHODS


Ninety-nine patients undergoing lumbar discectomy under GA with Surgical Pleth Index (SPI)-guided fentanyl (FNT) administration were randomly assigned to receive IA combined with either 0.2% bupivacaine (BPV) or 0.2% ropivacaine (RPV) with FNT 50 μg and compared with controls (BF, RF, and C groups, respectively).
RESULTS


Ninety-four patients were included in the final analysis. Adjusted according to SPI, total intraoperative FNT dosages did not differ between the study groups (p = 0.23). The proportion of patients who reported SPP was the highest in group C (41.9%) than in the RF (12.9%) and BF groups (31.3%) (p < 0.05). Mild pain was experienced by 67.7%, 53.1% and 32.3% of patients from the RF, BF and C groups, respectively (p < 0.01). Morphine requirement was the highest in the control group (7.1 ± 5.9 mg), followed by the RF (2.7 ± 5.3 mg) and BF groups (4 ± 4.9 mg) (p < 0.05).
CONCLUSIONS


IA using RPV/FNT mixture significantly reduced SPP and postoperative demand for morphine in patients subjected to lumbar discectomy under GA.",2020,"Adjusted according to SPI, total intraoperative FNT dosages did not differ between the study groups (p = 0.23).","['Ninety-four patients were included in the final analysis', 'Ninety-nine patients undergoing lumbar discectomy under GA with Surgical Pleth Index (SPI)-guided fentanyl (FNT) administration', 'patients subjected to lumbar discectomy under GA', 'patients subjected to open lumbar discectomy']","['infiltration anaesthesia', 'morphine', 'IA combined with either 0.2% bupivacaine (BPV) or 0.2% ropivacaine (RPV) with FNT', 'RPV/FNT mixture', 'lumbar discectomy under surgical pleth index-guided general anaesthesia']","['Mild pain', 'perioperative outcomes', 'SPP and postoperative demand', 'Morphine requirement', 'proportion of patients who reported SPP']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0234945', 'cui_str': 'Anesthesia, Infiltration'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",99.0,0.0517236,"Adjusted according to SPI, total intraoperative FNT dosages did not differ between the study groups (p = 0.23).","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Stasiowski', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland. Electronic address: mstasiowski@sum.edu.pl.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Missir', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Szumera', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Stasiak', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szopa', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Błaszczyk', 'Affiliation': 'Department of Neurosurgery, UCK in Katowice, Katowice, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Możdżyński', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Majchrzak', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Tymowski', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Niewiadomska', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Medical Sciences in Bytom, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ładziński', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Krawczyk', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland; Department of Anaesthesiology and Intensive Therapy, Regional Hospital in Sosnowiec, Sosnowiec, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kaspera', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland. Electronic address: wkaspera@sum.edu.pl.'}]",Advances in medical sciences,['10.1016/j.advms.2019.12.006']
345,32037269,Comparison of Antiplatelet Therapies for Prevention of Patent Foramen Ovale-Associated Stroke.,"AIMS


The REDUCE study demonstrated a reduction in the risk of recurrent stroke with patent foramen ovale closure and antiplatelet therapy compared to antiplatelet therapy alone. The clinicians were allowed to choose among aspirin, clopidogrel, or aspirin/dipyridamole with the expectation that all antiplatelet therapies would have similar efficacy in this population. We tested that presumption by comparing recurrent stroke rates among antiplatelet agents within the control arm of the trial.
METHODS


We evaluated patients in REDUCE study who were randomized to the medical arm. The primary endpoint for this analysis was freedom from clinical ischemic stroke through at least 2 years of follow-up, to a maximum of 5 years. In the primary analysis, antiplatelet treatment was defined as the agent during the week prior to a recurrent stroke or last known contact.
RESULTS


Of 223 patients in the medical treatment arm, the initial agent was aspirin 52%, clopidogrel 30%, and aspirin/dipyridamole 12%. Patients treated with aspirin were similar to those treated with alternatives, but were more likely to be enrolled in the United States. The last reported agent was aspirin alone in 55%, clopidogrel alone in 31%, aspirin/dipyridamole in 7%, and other/nothing/missing in 7%. Recurrent stroke rates were similar for all 3 antiplatelet regimens in unadjusted and adjusted analyses, with no overall difference among agents (P= .17).
CONCLUSIONS


Among patients with patent foramen ovale-associated stroke who were managed medically, there were no differences among antiplatelet agents in the risk of recurrent stroke, though confidence intervals were wide.",2020,"Among patients with patent foramen ovale-associated stroke who were managed medically, there were no differences among antiplatelet agents in the risk of recurrent stroke, though confidence intervals were wide.","['223 patients in the medical treatment arm, the initial agent was']","['antiplatelet therapy alone', 'aspirin, clopidogrel, or aspirin/dipyridamole', 'clopidogrel', 'aspirin/dipyridamole', 'aspirin']","['recurrent stroke rates', 'freedom from clinical ischemic stroke', 'Recurrent stroke rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0732279', 'cui_str': 'Aspirin / Dipyridamole'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",,0.0296037,"Among patients with patent foramen ovale-associated stroke who were managed medically, there were no differences among antiplatelet agents in the risk of recurrent stroke, though confidence intervals were wide.","[{'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: kasner@mail.med.upenn.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Randall', 'Affiliation': 'WL Gore and Associates, Flagstaff, Arizona.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Helle K', 'Initials': 'HK', 'LastName': 'Iversen', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Risto O', 'Initials': 'RO', 'LastName': 'Roine', 'Affiliation': 'Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sjostrand', 'Affiliation': 'Karolinska Instituet, Stockholm, Sweden.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Rhodes', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2019.104632']
346,32307878,Changes in blood parameters after intramuscular testosterone ester injections - Implications for anti-doping.,"Testosterone treatment stimulates the production of red blood cells and alters iron homeostasis. Thus, we investigated whether the 'haematological module' of the athlete biological passport (ABP) used by the World Anti-Doping Agency can be used to indicate misuse of testosterone. Nineteen eugonadal men received intramuscular injections of either 250 mg Sustanon®, a blend of four testosterone esters, or placebo on days 0 and 21 in a randomized, placebo-controlleddouble-blind design. Urine samples and blood samples were collected twice pre-treatment, at least 5 days apart, and on days 1, 3, 5, 10 and 14 post-injections to assess steroidal and haematological biomarkers of the ABP. The steroidal profile was flagged suspicious in all Sustanon®-treated subjects, whereas the haematological profile was flagged suspicious in six out of nine subjects. When both sensitivity and specificity were considered, reticulocyte percentage (RET%) appeared as the best marker of the haematological module for implying testosterone ester misuse. Atypical blood passport samples were used to select time points for further isotope-ratio mass spectrometry (IRMS) analysis of testosterone and its metabolites in simultaneously collected urine. In addition to the testosterone (T) to epitestosterone (E) ratio, the RET% and OFF-Score could help identify suspicious samples for more targeted IRMS testing. The results demonstrate that unexpected fluctuations in RET% can indicate testosterone doping if samples are collected 3-10 days after injection. From an anti-doping perspective, the haematological and steroidal modules of the ABP should complement each other when planning targeted follow-up testing and substantiating likely misuse of testosterone.",2020,"When considering both sensitivity and specificity, RET% appeared as the best marker of the hematological module for implying testosterone ester misuse.",['Nineteen eugonadal men'],"['Athlete Biological Passport (ABP) used by the World Anti-Doping Agency (WADA', 'intramuscular injections of either 250 mg Sustanon®, a blend of four testosterone esters, or placebo', 'Testosterone', 'placebo']","['blood parameters', 'red blood cell production and alters iron homeostasis']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0075665', 'cui_str': 'Sustanon'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",9.0,0.0740844,"When considering both sensitivity and specificity, RET% appeared as the best marker of the hematological module for implying testosterone ester misuse.","[{'ForeName': 'Sara Amalie', 'Initials': 'SA', 'LastName': 'Solheim', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mørkeberg', 'Affiliation': 'Anti Doping Denmark, Brøndby, Denmark.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Dehnes', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Hullstein', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Juul', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emmie N', 'Initials': 'EN', 'LastName': 'Upners', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Drug testing and analysis,['10.1002/dta.2803']
347,32208178,Utilizing Community Engagement Studios to inform patient experience in a multicenter randomized control trial.,"OBJECTIVE


To determine whether a community engagement approach can provide feedback for implementation of valuable measures to improve the outcome of a clinical trial.
METHODS


Review of the results from a Community Engagement Studio (CE Studio) for the ValEAR trial: an NIH-funded, multi-institutional study designed to research the efficacy of valganciclovir in the treatment of congenital cytomegalovirus (cCMV)-induced hearing loss. Participants were given information about the trial then asked a series of questions to assess their input on the merits or weaknesses affecting their participation in the trial.
RESULTS


Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio. The overall theme from the responses was a desire to advance the field but a need to clearly understand the risks and benefits of participation. Many requested more educational resources, more printed materials, or greater access to researchers if questions arose. Many welcomed having patient stories and information displayed in a dedicated website or through social media.
CONCLUSION


This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial. In response to parental comments, two educational videos were created: one on the general topic of cCMV and the other specific to the CMV ValEAR trial. Researchers who wish to optimize their clinical trial's success should consider incorporating a CE Studio into their study design.",2020,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"['congenital cytomegalovirus (cCMV)-induced hearing loss', 'Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio']","['Community Engagement Studio (CE Studio', 'valganciclovir']",[],"[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection (disorder)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}]",[],13.0,0.130066,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nielson', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'C Amanda', 'Initials': 'CA', 'LastName': 'Kull', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Park', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: Albert.Park@hsc.utah.edu.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110007']
348,31978697,The effect of medical treatment on nasal exhaled nitric oxide (NO) in patients with persistent allergic rhinitis: A randomized control study.,"PURPOSE


This study aimed to evaluate the role of nasal nitric oxide (NO) in the management of patients with persistent allergic rhinitis (PER).
METHODS


It was a randomized and comparative study. The study subjects were classified as controls (healthy subjects) or patients with PER based on defined criteria. All clinical, functional and biological data were collected for analyzing. Nasal fractional exhaled nitric oxide (FENO) was measured by electroluminescence device. Patients with PER were randomized for treatment with antihistamine (ATH) combined with leukotriene receptor antagonists (LRA) or only with intranasal steroids (INS).
RESULTS


During two years, 501 subjects were included: 234 control subjects and 267 patients with PER. The levels of nasal NO, total IgE, blood eosinophil counts, and apnea-hypopnea index (AHI) in patients with PER were higher than controls (P < 0.001; P < 0.05; P < 0.05; P < 0.01; respectively). There were statistically significant correlations between nasal NO, nasal peak flows, total IgE, and blood eosinophil counts in patients with PER (R = -0.687 and P = 0.0012; R = -0.643 and P = 0.0018; R = 0.432 and P = 0.0024; R = 0.445 and P = 0.002; respectively). After 6 months of treatment, patients treated with INS had greater improvement of clinical symptoms and reduction of nasal NO values than patients treated with ATH + LRA (985 ± 253 vs. 732 ± 298 ppb; P < 0.05).
CONCLUSION


Nasal NO measurement is a useful tool for the follow-up of patients with PER. It also helps clinicians to estimate the level of response to treatment in patients with PER.",2020,"After 6 months of treatment, patients treated with INS had greater improvement of clinical symptoms and reduction of nasal","['Patients with PER', 'patients with PER', 'patients with persistent allergic rhinitis (PER', 'study subjects were classified as controls (healthy subjects) or patients with PER based on defined criteria', 'patients with persistent allergic rhinitis', '501 subjects were included: 234 control subjects and 267 patients with PER']","['nasal nitric oxide (NO', 'antihistamine (ATH) combined with leukotriene receptor antagonists (LRA) or only with intranasal steroids (INS', 'INS', 'medical treatment']","['nasal', 'Nasal fractional exhaled nitric oxide (FENO', 'total IgE, blood eosinophil counts, and apnea-hypopnea index (AHI', 'clinical symptoms and reduction of nasal', 'levels of nasal', 'nasal exhaled nitric oxide (NO', 'Nasal', 'NO, nasal peak flows, total IgE, and blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3542962', 'cui_str': 'Leukotriene receptor antagonists for obstructive airway diseases'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0429204', 'cui_str': 'Nasal peak air flow (observable entity)'}]",501.0,0.0186508,"After 6 months of treatment, patients treated with INS had greater improvement of clinical symptoms and reduction of nasal","[{'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Health of Sciences Department, Thang Long University, Hanoi City, Viet Nam.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Van-Quang', 'Affiliation': 'ENT Department, Binh Duong General Hospital, Binhduong Province, Viet Nam.'}, {'ForeName': 'Binh', 'Initials': 'B', 'LastName': 'Nguyen-Thanh', 'Affiliation': 'Internal Medicine Department, Ho Chi Minh University of Medicine and Pharmacy, Hochiminh City, Viet Nam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Dao-Van', 'Affiliation': 'Health of Sciences Department, Thang Long University, Hanoi City, Viet Nam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Clinical Research Center, Lam Dong Medical College, Dalat City, Viet Nam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2019.12.004']
349,30821047,"Clinical pharmacology study of ipragliflozin in Japanese patients with type 1 diabetes mellitus: A phase 2, randomized, placebo-controlled trial.","AIM


To evaluate the pharmacodynamics, pharmacokinetics, and safety of the novel oral sodium-glucose co-transporter-2 inhibitor, ipragliflozin, in Japanese patients with type 1 diabetes mellitus.
MATERIALS AND METHODS


We conducted a multicentre, double-blind, placebo-controlled, parallel-group study. Patients were randomized to receive 25, 50, or 100 mg/day ipragliflozin or placebo for 2 weeks. Key pharmacokinetic endpoints included area under the concentration-time curve 24 hours postdose (AUC 24h  ), maximum plasma concentration (C max  ), and renal clearance. Key pharmacodynamic endpoints included 24-hour urinary glucose excretion, mean plasma glucose AUC 0-24h  , and mean renal glucose clearance. Changes in total, basal, and bolus insulin dosages were recorded. Adverse events (AEs) were monitored for safety.
RESULTS


Dose-dependent increases were observed in AUC 24h  and C max  on days 1 and 14 for 25-, 50-, and 100-mg ipragliflozin. The mean plasma glucose AUC 0-24h  was lower than that of placebo and the mean renal glucose clearance increased in a dose-dependent manner from baseline, but remained unchanged in the placebo group. The mean (standard deviation) change from baseline in total daily insulin dose was greater in the ipragliflozin 25-, 50-, and 100-mg groups (-14.77 ± 14.04%, -18.40 ± 12.49% and -19.25 ± 16.77%, respectively), than placebo (-4.51 ± 16.28%). Most AEs were mild in severity; no patients discontinued the study because of treatment-emergent AEs.
CONCLUSIONS


The pharmacokinetic and pharmacodynamic properties of ipragliflozin in Japanese patients with type 1 diabetes mellitus were confirmed. Increases in urinary glucose excretion lead to dose-dependent decreases in plasma glucose. Concomitant insulin dose decreased with ipragliflozin treatment. No clinically relevant safety concerns were identified.",2019,"RESULTS


Dose-dependent increases were observed in AUC 24h  and C max  on days 1 and 14 for 25-, 50-, and 100-mg ipragliflozin.",['Japanese patients with type 1 diabetes mellitus'],"['ipragliflozin or placebo', 'novel oral sodium-glucose co-transporter-2 inhibitor, ipragliflozin', 'placebo', 'ipragliflozin']","['AUC 24h  and C max', 'plasma glucose', '24-hour urinary glucose excretion, mean plasma glucose AUC 0-24h  , and mean renal glucose clearance', 'mean renal glucose clearance', 'pharmacodynamics, pharmacokinetics, and safety', 'area under the concentration-time curve 24\u2009hours postdose (AUC 24h  ), maximum plasma concentration (C max  ), and renal clearance', 'Changes in total, basal, and bolus insulin dosages', 'mean plasma glucose AUC 0-24h', 'total daily insulin dose', 'Adverse events (AEs', 'urinary glucose excretion']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.394147,"RESULTS


Dose-dependent increases were observed in AUC 24h  and C max  on days 1 and 14 for 25-, 50-, and 100-mg ipragliflozin.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isaka', 'Affiliation': 'Astellas Pharma Inc., Japan/Asia Clinical Development, Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., Japan/Asia Clinical Development, Tokyo, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Sakatani', 'Affiliation': 'Astellas Pharma Inc., Japan/Asia Data Science Development, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13679']
350,27813248,Application of a low polyphenol or low ellagitannin dietary intervention and its impact on ellagitannin metabolism in men.,"SCOPE


Plant polyphenols are widespread in the American diet, yet estimated intake is uncertain. We examine the application of the Polyphenol Explorer® (PED) database to quantify polyphenol and ellagitannin (ET) intake of men with prostate cancer and tested the implementation of diets restricted in polyphenols or ETs.
METHODS AND RESULTS


Twenty-four men enrolled in a 4-week trial were randomized to usual, low-polyphenol or low-ET diet. Estimated polyphenol and ET intakes were calculated from 3-day diet records utilizing the PED. Urine and plasma metabolites were quantified by UPLC-MS. Adherence to the restricted diets was 95% for the low polyphenol and 98% for low-ET diet. In the usual diet, estimated dietary polyphenol intake was 1568 ± 939 mg/day, with coffee/tea beverages (1112 ± 1028 mg/day) being the largest contributors and estimated dietary ET intake was 12 ± 13 mg/day. The low-polyphenol and low-ET groups resulted in a reduction of total polyphenols by 45% and 85%, respectively, and omission of dietary ETs. UPLC analysis of urinary host and microbial metabolites reflect ET intake.
CONCLUSION


PED is a useful database for assessing exposure to polyphenols. Diets restricted in total polyphenol or ET intake are feasible and UPLC assessment of ET metabolites is reflective of dietary intake.",2017,"The low-polyphenol and low-ET groups resulted in a reduction of total polyphenols by 45% and 85%, respectively, and omission of dietary ETs.","['men', 'Twenty-four men enrolled in a 4-week trial', 'men with prostate cancer and tested the implementation of diets restricted in polyphenols or ETs']","['Polyphenol Explorer® (PED) database to quantify polyphenol and ellagitannin (ET) intake', 'low polyphenol or low ellagitannin dietary intervention', 'low-polyphenol or low-ET diet']","['ellagitannin metabolism', 'Estimated polyphenol and ET intakes', 'Urine and plasma metabolites', 'total polyphenols']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0059030', 'cui_str': 'ellagitannin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0059030', 'cui_str': 'ellagitannin'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0042037'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.0157724,"The low-polyphenol and low-ET groups resulted in a reduction of total polyphenols by 45% and 85%, respectively, and omission of dietary ETs.","[{'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Roberts', 'Affiliation': 'The OSU Interdisciplinary Ph.D. Program in Nutrition, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Grainger', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Thomas-Ahner', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Hinton', 'Affiliation': 'Division of Biostatistics, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Junnan', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'The OSU Interdisciplinary Ph.D. Program in Nutrition, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Riedl', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Vodovotz', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Ronney', 'Initials': 'R', 'LastName': 'Abaza', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schwartz', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201600224']
351,32103326,"Prevention of anastomotic leak in rectal cancer surgery with local antibiotic decontamination: a prospective, randomized, double-blind, placebo-controlled single center trial.","PURPOSE


Anastomotic leak and other infectious complications are septic complications of rectal cancer surgery caused by bacteria. Data from registry analysis show a beneficial effect of local antimicrobial administration on anastomotic leaks, but data are inconsistent in recent clinical trials. Therefore, our aim was to study the efficacy of topical antibiotic treatment on the incidence of anastomotic leaks in rectal cancer surgery.
METHODS


A prospective, randomized, double-blind and placebo-controlled, single center trial was conducted. Patients received either placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B four times per day starting the day before surgery until postoperative day 7. If a protective ileostomy was created, a catheter was placed transanally and the medication was administered locally to the anastomotic site. All patients received an intravenous perioperative antibiotic prophylaxis.
RESULTS


The trial had to be stopped for ethical reasons after first interim analysis with 80 patients instead of the initially planned 280 patients. Of the 40 patients randomized to receive placebo, eight (20%) developed anastomotic leak compared to only 2 (5%) in the treatment group of 40 patients (decontamination) with significant difference in the χ 2  test (p = 0.0425). Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312). One patient (2.5%) in the placebo group died (p = 0.3141).
CONCLUSION


Local decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B is safe and effective in the prevention of anastomotic leak in rectal cancer surgery.",2020,Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312).,"['80 patients instead of the initially planned 280 patients', 'rectal cancer surgery']","['topical antibiotic treatment', 'rectal cancer surgery with local antibiotic decontamination', 'placebo', 'intravenous perioperative antibiotic prophylaxis', 'placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B', 'polymyxin, tobramycin, vancomycin, and amphotericin B']","['anastomotic leak', 'infectious complications', 'anastomotic leaks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0032539', 'cui_str': 'Polymyxins'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.703387,Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312).,"[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Schardey', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Wirth', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany. Ulrich.Wirth@med.uni-muenchen.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Strauss', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kasparek', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Jauch', 'Affiliation': 'Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.'}]",International journal of colorectal disease,['10.1007/s00384-020-03544-8']
352,32108263,Effect of vitamin D deficiency on depressive symptoms in child and adolescent psychiatric patients: results of a randomized controlled trial.,"PURPOSE


While observational studies revealed inverse associations between serum vitamin D levels [25(OH)D] and depression, randomized controlled trials (RCT) in children and adolescents are lacking. This RCT examined the effect of an untreated vitamin D deficiency compared to an immediate vitamin D 3  supplementation on depression scores in children and adolescents during standard day and in-patient psychiatric treatment.
METHODS


Patients with vitamin D deficiency [25(OH)D ≤ 30 nmol/l] and at least mild depression [Beck Depression Inventory II (BDI-II) > 13] (n = 113) were 1:1 randomized into verum (VG; 2640 IU vitamin D 3 /d) or placebo group (PG) in a double-blind manner. During the intervention period of 28 days, both groups additionally received treatment as usual. BDI-II scores were assessed as primary outcome, DISYPS-II (Diagnostic System for Mental Disorders in Childhood and Adolescence, Self- and Parent Rating) and serum total 25(OH)D were secondary outcomes.
RESULTS


At admission, 49.3% of the screened patients (n = 280) had vitamin D deficiency. Although the intervention led to a higher increase of 25(OH)D levels in the VG than in the PG (treatment difference: + 14 ng/ml; 95% CI 4.86-23.77; p = 0.003), the change in BDI-II scores did not differ (+ 1.3; 95% CI - 2.22 to 4.81; p = 0.466). In contrast, DISYPS parental ratings revealed pronounced improvements of depressive symptoms in the VG (- 0.68; 95% CI - 1.23 to - 0.13; p = 0.016).
CONCLUSION


Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study. Future trials should consider clinician-rated depressive symptoms as primary outcome.
TRIAL REGISTRATION


""German Clinical Trials Register"" (https://www.drks.de), registration number: DRKS00009758.",2020,"Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study.","['Patients with vitamin D deficiency [25(OH)D\u2009≤\u200930\xa0nmol/l] and at least mild depression [Beck Depression Inventory II (BDI-II)\u2009>\u200913', 'children and adolescents during standard day and in-patient psychiatric treatment', 'n\u2009=\u2009113', 'children and adolescents are lacking', 'child and adolescent psychiatric patients']","['vitamin D supplementation', 'placebo', 'vitamin D deficiency', 'verum', 'immediate vitamin D 3  supplementation']","['depression scores', 'change in BDI-II scores', 'DISYPS-II (Diagnostic System for Mental Disorders in Childhood and Adolescence, Self- and Parent Rating) and serum total 25(OH)D', 'vitamin D deficiency', 'serum vitamin D levels [25(OH)D] and depression', 'BDI-II scores', '25(OH)D levels', 'depressive symptoms', 'self-rated depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178546', 'cui_str': 'Mental disorder in childhood'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.642682,"Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Libuda', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany. lars.libuda@uni-due.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Timmesfeld', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Antel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hirtz', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bauer', 'Affiliation': 'Pediatric Endocrinology and Diabetology, Klinik für Kinderheilkunde II, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Führer', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Zwanziger', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Öztürk', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Langenbach', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hahn', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ring', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Triinu', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hinney', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bühlmeier', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hebebrand', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Grasemann', 'Affiliation': 'Pediatric Endocrinology and Diabetology, Klinik für Kinderheilkunde II, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Föcker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}]",European journal of nutrition,['10.1007/s00394-020-02176-6']
353,32152372,Author Correction: A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Author Correction', 'children with cystic fibrosis']",['rosuvastatin'],['kidney toxicity'],"[{'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0366007,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McWilliam', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, Merseyside, United Kingdom. stevemcw@liv.ac.uk.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greenhalf', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rosalind L', 'Initials': 'RL', 'LastName': 'Smyth', 'Affiliation': 'University College London, Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, and MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-61783-9']
354,30833149,"A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial.","BACKGROUND


Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers.
AIM


To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA.
METHODS


This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March-July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA.
MAIN OUTCOME MEASURES


Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection.
RESULTS


Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection-related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
CLINICAL IMPLICATIONS


This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA.
STRENGTH AND LIMITATIONS


This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period.
CONCLUSIONS


Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety. Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577-585.",2019,"Filler injection-related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
","['human PA', 'Penile Augmentation', '72 patients with small penis syndrome were enrolled from 3 institutions between March-July 2016']","['PLA', 'HA and PLA fillers', 'Hyaluronic Acid and Polylactic Acid Filler Injection', 'hyaluronic acid (HA) and polylactic acid (PLA) filler injection']","['overall satisfaction level', 'Penile girth and satisfaction', 'Filler injection-related adverse events', 'Satisfaction levels', 'efficacy and safety', 'mean penile girth increase', 'Penile girth']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0240701', 'cui_str': 'Small penis (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0071443', 'cui_str': 'poly(lactic acid)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",72.0,0.0745538,"Filler injection-related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
","[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Kangdong Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Kangdong Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon Sacred Heart Hospital, Chuncheon, Korea. Electronic address: rheewk@hanmail.net.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.01.310']
355,30450787,Dose-dependent effects of continuous positive airway pressure for sleep apnea on weight or metabolic function: Individual patient-level clinical trial meta-analysis.,"Therapeutic-continuous positive airway pressure seems to increase weight compared with placebo-continuous positive airway pressure. It is not known whether weight gain with therapeutic-continuous positive airway pressure dose is dependent or whether it causes metabolic dysfunction. Data synthesis of three randomised placebo-continuous positive airway pressure-controlled trials (2-3 months) was performed to test whether there is a dose-dependent effect of continuous positive airway pressure on weight. Fasting glucose, insulin, insulin resistance (homeostatic model assessment), lipids and visceral abdominal fat were also tested to determine any effect on metabolic function. Mixed-model analysis of variance was used to quantify these effects. One-hundred and twenty-eight patients were analysed. Overall there was a small increase in weight with therapeutic-continuous positive airway pressure use compared with placebo-continuous positive airway pressure (difference: 1.17 kg; 0.37-1.97, p = 0.005), which was greater with high-use therapeutic-continuous positive airway pressure compared with high-use placebo-continuous positive airway pressure (1.45 kg; 0.10-2.80, p = 0.04). Continuous positive airway pressure use as a continuous variable was also significantly associated with weight change in continuous positive airway pressure users (0.30 kg hr -1   night -1  ; 0.04-0.56, p = 0.001), but not in placebo users (0.04 kg hr -1   night -1  ; -0.22 to 0.26, p = 0.76). Neither therapeutic-continuous positive airway pressure nor the dose of therapeutic-continuous positive airway pressure caused any changes to metabolic outcomes. The weight gain effects of medium-term therapeutic-continuous positive airway pressure appear modest and are not accompanied by any adverse metabolic effects.",2019,Neither therapeutic-continuous positive airway pressure nor the dose of therapeutic-continuous positive airway pressure caused any changes to metabolic outcomes.,['One-hundred and twenty-eight patients were analysed'],"['continuous positive airway pressure', 'placebo']","['weight with therapeutic-continuous positive airway pressure', 'weight change', 'Fasting glucose, insulin, insulin resistance (homeostatic model assessment), lipids and visceral abdominal fat']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}]",128.0,0.0499497,Neither therapeutic-continuous positive airway pressure nor the dose of therapeutic-continuous positive airway pressure caused any changes to metabolic outcomes.,"[{'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Swati M', 'Initials': 'SM', 'LastName': 'Murugan', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Roo', 'Initials': 'R', 'LastName': 'Killick', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Cayanan', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.'}]",Journal of sleep research,['10.1111/jsr.12788']
356,30880289,Oxygen compared to air during exercise training in COPD with exercise-induced desaturation.,"Almost half the patients referred to pulmonary rehabilitation with chronic obstructive pulmonary disease (COPD) desaturate during exercise. Although oxygen supplementation may ameliorate oxygen desaturation, the effects on outcomes of exercise training have not been rigorously evaluated. This study aimed to determine whether supplemental oxygen during exercise training was more effective than medical air in improving exercise capacity and health-related quality of life (HRQoL) in people with COPD.People with COPD who demonstrated oxygen desaturation <90% during the 6-min walk test were recruited to this multicentre trial with randomisation (independent, concealed allocation) to either an Oxygen group or Air group, blinding (participants, exercise trainers and  European Respiratory Journal  assessors) and intention-to-treat analysis. Both groups received the respective gas from concentrators  via  nasal prongs at 5 L·min -1  during exercise training consisting of treadmill and cycle exercise, three times per week for 8 weeks. Primary outcomes were the endurance shuttle walk test (ESWT) time and Chronic Respiratory Disease Questionnaire (CRQ)-Total score.111 participants (60 males), mean±sd age 69±7 years, with moderate to severe COPD were recruited and 97 completed (Oxygen group n=52; Air group n=45). At the end of the 8-week training programme there were no between-group differences in change in ESWT (mean difference 15 s (95% CI -106-136 s) or change in CRQ-Total (0.0 points (95% CI -0.3-0.3 points)). Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.",2019,"Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.","['people with COPD.People with COPD who demonstrated oxygen desaturation <90% during the 6-min walk test', 'CRQ)-Total score.111 participants (60 males), mean±sd age 69±7 years, with moderate to severe COPD were recruited and 97 completed (Oxygen group n=52; Air group n=45', 'patients referred to pulmonary rehabilitation with chronic obstructive pulmonary disease (COPD) desaturate during exercise']","['oxygen supplementation', 'Oxygen compared to air during exercise training', 'respective gas from concentrators  via  nasal prongs at 5\u2005L·min -1  during exercise training consisting of treadmill and cycle exercise', 'supplemental oxygen during exercise training', 'Oxygen group or Air group, blinding (participants, exercise trainers and  European Respiratory Journal  assessors) and intention-to-treat analysis']","['exercise capacity and health-related quality of life (HRQoL', 'endurance shuttle walk test (ESWT) time and Chronic Respiratory Disease Questionnaire', 'change in ESWT', 'CRQ-Total', 'ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs (physical object)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1960627', 'cui_str': 'Endurance Shuttle Walk Test'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.132649,"Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Zoe J', 'Initials': 'ZJ', 'LastName': 'McKeough', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Regina W M', 'Initials': 'RWM', 'LastName': 'Leung', 'Affiliation': 'Dept of Physiotherapy, Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Discipline of Physiotherapy, School of Allied Health, LaTrobe University, Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Southport, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Lissa M', 'Initials': 'LM', 'LastName': 'Spencer', 'Affiliation': 'Dept of Physiotherapy, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': 'Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Annemarie L', 'Initials': 'AL', 'LastName': 'Lee', 'Affiliation': 'Dept of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Seale', 'Affiliation': 'Dept of Physiotherapy, Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Dept of Physiotherapy, Sir Charles Gardiner Hospital, Perth, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Institute for Breathing and Sleep, Melbourne, Australia.'}]",The European respiratory journal,['10.1183/13993003.02429-2018']
357,30740838,Use of targeted memory reactivation enhances skill performance during a nap and enhances declarative memory during wake in healthy young adults.,"Sleep is an important component of motor memory consolidation and learning, providing a critical tool to enhance training and rehabilitation. Following initial skill acquisition, memory consolidation is largely a result of non-rapid eye movement sleep over either a full night or a nap. Targeted memory reactivation is one method used to enhance this critical process, which involves the pairing of an external cue with task performance at the time of initial motor skill acquisition, followed by replay of the same cue during sleep. Application of targeted memory reactivation during sleep leads to increased functional connectivity within task-related brain networks and improved behavioural performance in healthy young adults. We have previously used targeted memory reactivation throughout the first two slow-wave sleep cycles of a full night of sleep to enhance non-dominant arm throwing accuracy in healthy young adults. Here, we aimed to determine whether application of targeted memory reactivation throughout a 1-hr daytime nap was sufficient to enhance performance on the same non-dominant arm throwing task in healthy young adults. Participants were allocated to either nap or no nap, and within those groups half received targeted memory reactivation throughout a 1-hr between-session period, leading to four groups. Only participants who slept between sessions while receiving targeted memory reactivation enhanced their throwing accuracy upon beginning the second session. Future studies will aim to use this technique as an adjunct to traditional physical rehabilitation with individuals with neurologic diagnoses such as stroke.",2019,Application of targeted memory reactivation during sleep leads to increased functional connectivity within task-related brain networks and improved behavioural performance in healthy young adults.,"['individuals with neurologic diagnoses such as stroke', 'healthy young adults']","['nap or no nap, and within those groups half received targeted memory reactivation']","['behavioural performance', 'skill performance', 'declarative memory']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0151391,Application of targeted memory reactivation during sleep leads to increased functional connectivity within task-related brain networks and improved behavioural performance in healthy young adults.,"[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Maryland, Baltimore, Maryland.'}]",Journal of sleep research,['10.1111/jsr.12832']
358,30851062,Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial.,"AIM


The aim of this study was to evaluate the efficacy and safety of evolocumab with background atorvastatin in Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia.
MATERIALS AND METHODS


This is a pre-specified analysis of patients in the BERSON study (ClinicalTrials.gov, NCT02662569) in China. Patients initiated background atorvastatin 20 mg/d, after which they were randomized 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or to placebo Q2W or QM. Co-primary endpoints were percentage change in LDL cholesterol (LDL-C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures and adverse events (AEs).
RESULTS


Among 453 patients randomized in China, 451 received at least one dose of study drug (evolocumab or placebo). Evolocumab significantly reduced LDL-C compared with placebo at week 12 (Q2W, -85.0%; QM, -74.8%) and at the mean of weeks 10 and 12 (Q2W, -80.4%; QM, -81.0%) (adjusted P < 0.0001 for all) when administered with background atorvastatin. Non-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C and VLDL-C significantly improved with evolocumab vs placebo. No new safety findings were observed with evolocumab. The incidence of diabetes AEs was higher with evolocumab compared with placebo. There were no differences over time between evolocumab and placebo in measures of glycaemic control.
CONCLUSIONS


In patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving background atorvastatin, evolocumab significantly reduced LDL-C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures.",2019,"Evolocumab significantly reduced LDL-C compared with placebo at week 12 (Q2W, -85.0%; QM, -74.8%) and at the mean of weeks 10 and 12 (Q2W, -80.4%; QM, -81.0%) (adjusted P < 0.0001 for all) when administered with background atorvastatin. Non-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C and VLDL-C significantly improved with evolocumab vs placebo.","['Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia', '453 patients randomized in China, 451 received at least one dose of study', 'patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving background', 'patients with type 2 diabetes and dyslipidaemia on background statin']","['placebo', 'atorvastatin, evolocumab', 'evolocumab 140\u2009mg every 2\u2009weeks (Q2W) or 420\u2009mg monthly (QM) or to placebo Q2W or QM', 'drug (evolocumab or placebo', 'evolocumab', 'evolocumab with background atorvastatin', 'evolocumab vs placebo', 'background atorvastatin']","['incidence of diabetes AEs', 'LDL cholesterol (LDL-C', 'glycaemic measures', 'atherogenic lipids, glycaemic measures and adverse events (AEs', 'LDL-C and other atherogenic lipids', 'glycaemic control', 'HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C and VLDL-C', 'efficacy and safety', 'LDL-C']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",453.0,0.376849,"Evolocumab significantly reduced LDL-C compared with placebo at week 12 (Q2W, -85.0%; QM, -74.8%) and at the mean of weeks 10 and 12 (Q2W, -80.4%; QM, -81.0%) (adjusted P < 0.0001 for all) when administered with background atorvastatin. Non-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C and VLDL-C significantly improved with evolocumab vs placebo.","[{'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zuyi', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Juming', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Freddy G', 'Initials': 'FG', 'LastName': 'Eliaschewitz', 'Affiliation': 'CPCLIN/DASA - Centro de Pesquisas Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Lorenzatti', 'Affiliation': 'Clinical Research and Cardiology, Instituto Medico DAMIC / Fundación Rusculleda, Córdoba, Argentina.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Monsalvo', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Hamer', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13700']
359,30859702,The effects of dream rebound: evidence for emotion-processing theories of dreaming.,"Suppressing thoughts often leads to a ""rebound"" effect, both in waking cognition (thoughts) and in sleep cognition (dreams). Rebound may be influenced by the valence of the suppressed thought, but there is currently no research on the effects of valence on dream rebound. Further, the effects of dream rebound on subsequent emotional response to a suppressed thought have not been studied before. The present experiment aimed to investigate whether emotional valence of a suppressed thought affects dream rebound, and whether dream rebound subsequently influences subjective emotional response to the suppressed thought. Participants (N = 77) were randomly assigned to a pleasant or unpleasant thought suppression condition, suppressed their target thought for 5 min pre-sleep every evening, reported the extent to which they successfully suppressed the thought, and reported their dreams every morning for 7 days. It was found that unpleasant thoughts were more prone to dream rebound than pleasant thoughts. There was no effect of valence on the success or failure of suppression during wakefulness. Dream rebound and successful suppression were each found to have beneficial effects for subjective emotional response to both pleasant and unpleasant thoughts. The results may lend support for an emotion-processing theory of dream function.",2019,Dream rebound and successful suppression were each found to have beneficial effects for subjective emotional response to both pleasant and unpleasant thoughts.,['Participants (N\u2005=\u200577'],['pleasant or unpleasant thought suppression condition'],"['subsequent emotional response', 'subjective emotional response']",[],"[{'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",77.0,0.0200275,Dream rebound and successful suppression were each found to have beneficial effects for subjective emotional response to both pleasant and unpleasant thoughts.,"[{'ForeName': 'Josie', 'Initials': 'J', 'LastName': 'Malinowski', 'Affiliation': 'School of Psychology, College of Applied Health and Communities, University of East London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Carr', 'Affiliation': 'Department of Psychology, College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Department of Psychology, College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Ingarfill', 'Affiliation': 'School of Psychology, College of Applied Health and Communities, University of East London, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Department of Psychology, University of Bedfordshire, Luton, Bedfordshire, UK.'}]",Journal of sleep research,['10.1111/jsr.12827']
360,32200051,What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial.,"OBJECTIVE


Different exercise types may yield different outcomes in osteoarthritis (OA) subgroups. The objective was to directly compare effectiveness of two exercise programs for people with medial knee OA and co-morbid obesity.
DESIGN


We performed a participant- and assessor-blinded randomized controlled trial. 128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2  were recruited from the community. Interventions were home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise for 12 weeks. Primary outcomes were change in overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 12 weeks. Secondary outcomes included other pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength.
RESULTS


123 (96%) participants were retained. There was no evidence of a between-group difference in change in pain (mean difference 0.73 units (95% confidence intervals (0.05,1.50)) or function (2.80 units (-1.17,6.76)), with both groups reporting improvements. For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98). Although adverse events were minor, more NWB group participants reported ≥1 adverse event (26/66 (39%) vs 14/62 (23%), p = 0.04).
CONCLUSIONS


Both exercise types similarly improved primary outcomes of pain and function and can be recommended for people with knee OA and obesity. WB exercise may be preferred given fewer adverse events and potential additional benefits on some secondary outcomes.
REGISTRATION


Prospectively registered (Australian New Zealand Clinical Trials Registry #12617001013358, 14/7/2017).",2020,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","['123 (96', 'OA subgroups', 'people with knee OA and obesity', 'people with medial knee OA and co-morbid obesity', '128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2  were recruited from the community', 'people with knee osteoarthritis and co-morbid obesity']","['WB exercise', 'exercise programs', 'home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise']","['overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68', 'adverse events', 'quality-of-life', 'adverse event', 'pain and function', 'change in pain', 'pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing (finding)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",128.0,0.215058,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: k.bennell@unimelb.edu.au.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: rachel.nelligan@unimelb.edu.au.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Kimp', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: alexander.kimp@unimelb.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: sarah.schwartz@unimelb.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Electronic address: jessica.kasza@monash.edu.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: timw@unimelb.edu.au.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Metcalf', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: b.metcalf@unimelb.edu.au.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'The University of Queensland, Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Sciences, QLD, Australia. Electronic address: p.hodges@uq.edu.au.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: ranash@unimelb.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.838']
361,31128077,Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.,"BACKGROUND


A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). A recent addition to these is prostatic urethral lift (PUL).
OBJECTIVES


To assess the effects of PUL for the treatment of LUTS in men with BPH.
SEARCH METHODS


We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, LILACS, Scopus, Web of Science, and Google Scholar), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up until 31 January 2019.
SELECTION CRITERIA


We included parallel group randomized controlled trials (RCTs). While we planned to include non-RCTs if RCTs had provided low-certainty evidence for a given outcome and comparison, we could not find any non-RCTs.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We planned subgroup analyses by age, prostate volume, and severity of baseline symptoms. We used the GRADE approach to rate the certainty of the evidence.
MAIN RESULTS


We included two RCTs with 297 participants comparing PUL to sham surgery or TURP. The mean age was 65.6 years and mean International Prostate Symptom Score was 22.7. Mean prostate volume was 42.2 mL. We considered review outcomes measured up to and including 12 months after randomization as short-term and later than 12 months as long-term. For patient-reported outcomes, lower scores indicate more urological symptom improvement and higher quality of life. In contrast, higher scores refers to better erectile and ejaculatory function.PUL versus sham: based on one study of 206 randomized participants with short follow-up (up to three months), PUL may lead to a clinically important improvement in urological symptom scores (mean difference (MD) -5.20, 95% confidence interval (CI) -7.44 to -2.96; low-certainty evidence) and likely improves quality of life (MD -1.20, 95% CI -1.67 to -0.73; moderate-certainty evidence). We are uncertain whether PUL increases major adverse events (very low-certainty evidence). There were no retreatments reported in either study group by three months. PUL likely results in little to no difference in erectile function (MD -1.40, 95% CI -3.24 to 0.44; moderate-certainty evidence) and ejaculatory function (MD 0.50, 95% CI -0.38 to 1.38; moderate-certainty evidence).PUL versus TURP: based on one study of 91 randomized participants with a short follow-up (up to 12 months), PUL may result in a substantially lesser improvement in urological symptom scores than TURP (MD 4.50, 95% CI 1.10 to 7.90; low-certainty evidence). PUL may result in a slightly reduced or similar quality of life (MD 0.30, 95% CI -0.49 to 1.09; low-certainty evidence). We are very uncertain whether PUL may cause fewer major adverse events but increased retreatments (both very low-certainty evidence). PUL probably results in little to no difference in erectile function (MD 0.80, 95% CI -1.50 to 3.10; moderate-certainty evidence), but probably results in substantially better ejaculatory function (MD 5.00, 95% CI 3.08 to 6.92; moderate-certainty evidence).With regards to longer term follow-up (up to 24 months) based on one study of 91 randomized participants, PUL may result in a substantially lesser improvement in urological symptom score (MD 6.10, 95% CI 2.16 to 10.04; low-certainty evidence) and result in little worse to no difference in quality of life (MD 0.80, 95% CI 0.00 to 1.60; low-certainty evidence). The study did not report on major adverse events. We are very uncertain whether PUL increases retreatment (very low-certainty evidence). PUL likely results in little to no difference in erectile function (MD 1.60, 95% CI -0.80 to 4.00; moderate-certainty evidence), but may result in substantially better ejaculatory function (MD 4.30, 95% CI 2.17 to 6.43; low-certainty evidence).We were unable to perform any of the predefined secondary analyses for either comparison.We found no evidence for other comparisons such as PUL versus laser ablation or enucleation.
AUTHORS' CONCLUSIONS


PUL appears less effective than TURP in improving urological symptoms both short-term and long term, while quality of life outcomes may be similar. The effect on erectile function appears similar but ejaculatory function may be better. We are uncertain about major adverse events short-term and found no long-term information. We are very uncertain about retreatment rates both short-term and long-term. We were unable to assess the effects of PUL in subgroups based on age, prostate size, or symptom severity and also could not assess how PUL compared to other surgical management approaches. Given the large numbers of alternative treatment modalities to treat men with LUTS secondary to BPH, this represents important information that should be shared with men considering surgical treatment.",2019,"AUTHORS' CONCLUSIONS


PUL appears less effective than TURP in improving urological symptoms both short-term and long term, while quality of life outcomes may be similar.","['297 participants comparing', 'men with benign prostatic hyperplasia', 'men with BPH', 'men with benign prostatic hyperplasia (BPH']","['PUL', 'TURP', 'PUL to sham surgery or TURP', 'transurethral resection of prostate (TURP', 'Prostatic urethral lift', 'PUL versus laser ablation or enucleation']","['Mean prostate volume', 'erectile function', 'urological symptom score', 'urological symptom improvement and higher quality of life', 'ejaculatory function', 'urological symptom scores', 'quality of life', 'mean International Prostate Symptom Score']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}]",91.0,0.239018,"AUTHORS' CONCLUSIONS


PUL appears less effective than TURP in improving urological symptoms both short-term and long term, while quality of life outcomes may be similar.","[{'ForeName': 'Jae Hung', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Urology, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon, Korea, South, 26426.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Karen Ann', 'Initials': 'KA', 'LastName': 'McCutcheon', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borofsky', 'Affiliation': ''}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Narayan', 'Affiliation': ''}, {'ForeName': 'Myung Ha', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dahm', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012832.pub2']
362,32299679,"A multicenter, randomized, placebo-controlled, double-blind phase 3 trial with open-arm comparison indicates safety and efficacy of nephroprotective therapy with ramipril in children with Alport's syndrome.","Children with Alport syndrome develop renal failure early in life. Since the safety and efficacy of preemptive nephroprotective therapy are uncertain we conducted a randomized, placebo-controlled, double-blind trial in 14 German sites of pediatric patients with ramipril for three to six years plus six months follow-up to determine these parameters. Pretreated children and those whose parents refused randomization became an open-arm control, which were compared to prospective real-world data from untreated children. The co-primary endpoints were safety (adverse drug reactions) and efficacy (time to progression). Out of 66 oligosymptomatic children, 22 were randomized and 44 joined the open-arm comparison. Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53). Although not significant, our results cautiously showed that ramipril therapy was effective: in the randomized arm, Ramipril decreased the risk of disease progression by almost half (hazard ratio 0.51 (0.12-2.20)), diminished the slope of albuminuria progression and the decline in glomerular filtration. In adjusted analysis, indications of efficacy were supported by prospective data from participants treated open label compared with untreated children, in whom ramipril again seemed to reduce progression by almost half (0.53 (0.22-1.29)). Incorporating these results into the randomized data by Bayesian evidence synthesis resulted in a more precise estimate of the hazard-ratio of 0.52 (0.19-1.39). Thus, our study shows the safety of early initiation of therapy and supports the hope to slow renal failure by many years, emphasizing the value of preemptive therapy. Hence, screening programs for glomerular hematuria in children and young adults could benefit from inclusion of genetic testing for Alport-related gene-variants.",2020,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"['66 oligosymptomatic children', 'Children with Alport syndrome develop renal failure early in life', 'children and young adults', ""children with Alport's syndrome"", '14 German sites of pediatric patients with ramipril for three to six years plus six months']","['placebo', 'Ramipril', 'ramipril', 'nephroprotective therapy with ramipril', 'preemptive nephroprotective therapy']","['slope of albuminuria progression', 'safety and efficacy', 'safety (adverse drug reactions) and efficacy (time to progression', 'glomerular filtration', 'reduce progression', 'risk of disease progression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C3267042', 'cui_str': 'Nephroprotective therapy'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",66.0,0.200707,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany. Electronic address: gross.oliver@med.uni-goettingen.de.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Lutz T', 'Initials': 'LT', 'LastName': 'Weber', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Latta', 'Affiliation': 'Clementine Kinderhospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fehrenbach', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen, Germany.""}, {'ForeName': 'Baerbel', 'Initials': 'B', 'LastName': 'Lange-Sperandio', 'Affiliation': ""Dr. v. Hauner Children's Hospital, Ludwig Maximilians University, Munich, Germany.""}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Zappel', 'Affiliation': 'Clinic of Pediatrics and Adolescent Medicine, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoyer', 'Affiliation': 'Pediatric Nephrology, Pediatrics II, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Staude', 'Affiliation': ""Pediatric Nephrology, University Children's Hospital Rostock, Rostock, Germany.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'König', 'Affiliation': ""University Children's Hospital Münster, Münster, Germany.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'John', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital, Jena, Germany.""}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gellermann', 'Affiliation': ""Pediatric Nephrology, Charité Children's Hospital, Berlin, Germany.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hoppe', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Galiano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital, Friedrich-Alexander-University Erlangen, Erlangen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hoecker', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Ehren', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lerch', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Kashtan', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boeckhaus', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.12.015']
363,32299733,Prospective randomized multicentre comparison on sibling oocytes comparing G-Series media system with antioxidants versus standard G-Series media system.,"RESEARCH QUESTION


Does the inclusion of three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA) improve human embryo development and pregnancy potential?
DESIGN


Prospective randomized multicentre comparison of sibling oocytes. A total of 1563 metaphase II oocytes from 133 patients in two IVF centres. Day 3 embryo and day 5/6 blastocyst quality were assessed. Good embryo quality on day 3 was defined as 8 to 10 cells with even cells and low fragmentation; good quality blastocysts as 3BB or greater. Clinical outcome was assessed on transfers of fresh or vitrified-warmed blastocyst on day 5.
RESULTS


Of the two-pronuclei, 40.7% (G-Series) and 50.2% (G-Series with A3 group) resulted in good quality embryos on day 3 (P < 0.05). The implantation rate by fetal sac was 39.2% and 50.6%, and by fetal heartbeat was 37.8% and 47.1% for the G-Series and G-Series with A3 group, respectively. When stratified by female patient age, patients 35-40 years had an implantation rate by fetal sac and heart of 23.5% in the G-Series compared with 57.5% (P < 0.05) and 50.0% (P < 0.05) in the A3 group. The ongoing pregnancies in patients 35-40 years were significantly higher in the A3 group (50%) compared with the control (25.8%) (P < 0.05).
CONCLUSIONS


The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate. Supplementation of antioxidants to IVF and culture media may therefore improve the viability of human embryos in assisted reproductive technologies, plausibly through the reduction of oxidative stress.",2020,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,['A total of 1563 metaphase II oocytes from 133 patients in two IVF centres'],"['three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA', 'G-Series media system with antioxidants versus standard G-Series media system']","['Good embryo quality', 'implantation rate by fetal sac and heart', 'transfers of fresh or vitrified-warmed blastocyst on day 5', 'implantation and pregnancy rate', 'fetal heartbeat', 'implantation rate by fetal sac', 'good quality embryos']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}]",,0.091776,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gardner', 'Affiliation': 'School of BioSciences, University of Melbourne, Parkville, Australia; Melbourne IVF, East Melbourne, Australia. Electronic address: david.gardner@unimelb.edu.au.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kuramoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigetoshi', 'Initials': 'S', 'LastName': 'Mitzumoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Montag', 'Affiliation': 'ilabcomm GmbH, Eisenachstrasse 34, Sankt Augustin, Germany.'}, {'ForeName': 'Atsumi', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.026']
364,32299734,A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval.,"RESEARCH QUESTION


Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation?
DESIGN


A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set.
RESULTS


Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups.
CONCLUSION


The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.",2020,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"['pain relief during oocyte retrieval', '170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre']","['pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine', 'fentanyl and 5 mg midazolam', 'pethidine', 'pethidine and diazepam', 'midazolam', 'diazepam', 'fentanyl and midazolam']","['postoperative side-effects', 'clinical pregnancy and ongoing pregnancy rates', 'pain levels', 'Vaginal and abdominal pain levels', 'vaginal and abdominal pain levels', 'vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates', 'abdominal pain', 'abdominal pain level during retrieval assessed by linear visual analogue scale', 'sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",170.0,0.597173,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"[{'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong. Electronic address: lsf087@ha.org.hk.'}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Nga', 'Affiliation': 'Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.021']
365,30935469,Anatomic Basis and Clinical Effect of Selective Dorsal Neurectomy for Patients with Lifelong Premature Ejaculation: A Randomized Controlled Trial.,"INTRODUCTION


Although guidelines from the American Urological Association and European Association of Urology do not consider surgical treatment for premature ejaculation (PE), the use of selective dorsal neurectomy (SDN) has increased for many years in Asian countries.
AIM


To evaluate anatomic basis and clinical effect of SDN in patients with PE in mainland China.
METHODS


All of the patients included in the study had redundant foreskin, and they were assigned to 2 groups: group 1, composed of 46 patients with redundant foreskin, and group 2, composed of 96 patients with redundant foreskin and PE. The patients in group 2 were further randomly classified into group 2a (n = 48) and group 2b (n = 48).
MAIN OUTCOME MEASURES


The number of dorsal penile nerve branches were compared among group 1, group 2a, and group 2b. Preoperative and postoperative intravaginal ejaculatory latency time (IELT), 5-item version of the International Index of Erectile Function, Premature Ejaculation Diagnostic Tool, and postoperative complications were compared between group 2a and group 2b.
RESULTS


The patients in group 2 had a greater number of dorsal penile nerve branches of 1-2-mm-diameter, ≥2-mm-diameter, and total branches than group 1. The postoperative IELT of group 2a (257.7 ± 205.7 seconds) was longer than that of group 2b (49.3 ± 26.1 seconds). Group 2a had more ejaculation controllability and lower Premature Ejaculation Diagnostic Tool scores than group 2b after the surgery (P < .001). We did not observe permanent numbness in glans, wound infection, or hematoma in any patients.
CLINICAL IMPLICATION


SDN is an effective treatment for lifelong PE patients who had poor response to medicine or refused oral medication.
STRENGTH & LIMITATIONS


This study has some strengths. First, the study made a comprehensive comparison based on both the numbers of dorsal penile nerve branches and the effect. Second, a randomized controlled trial design was used for the evaluation of SDN. It also possesses a limitation-we did not determine how many dorsal nerves should be selectively resected for each person to achieve optimal IELT prolongation.
CONCLUSION


The dorsal penile nerve branches of patients with lifelong PE are more and thicker than those without lifelong PE, and SDN is effective in improving lifelong PE by IELT prolongation and ejaculation controllability, with few postoperative complications. Liu Q, Li S, Zhang Y, et al. Anatomic Basis and Clinical Effect of Selective Dorsal Neurectomy for Patients with Lifelong Premature Ejaculation: A Randomized Controlled Trial. J Sex Med 2019;16:522-530.",2019,Group 2a had more ejaculation controllability and lower Premature Ejaculation Diagnostic Tool scores than group 2b after the surgery (P < .001).,"['patients with PE in mainland China.\nMETHODS\n\n\nAll of the patients included in the study had redundant foreskin, and they were assigned to 2 groups: group 1, composed of 46 patients with redundant foreskin, and group 2, composed of 96 patients with', 'Patients with Lifelong Premature Ejaculation', 'lifelong PE patients who had poor response to medicine or refused oral medication']","['redundant foreskin and PE', 'Selective Dorsal Neurectomy', 'SDN']","['number of dorsal penile nerve branches of 1-2-mm-diameter, ≥2-mm-diameter, and total branches', 'ejaculation controllability and lower Premature Ejaculation Diagnostic Tool scores', 'number of dorsal penile nerve branches', 'permanent numbness in glans, wound infection, or hematoma', 'Preoperative and postoperative intravaginal ejaculatory latency time (IELT), 5-item version of the International Index of Erectile Function, Premature Ejaculation Diagnostic Tool, and postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0345325', 'cui_str': 'Redundant prepuce (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0345325', 'cui_str': 'Redundant prepuce (disorder)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0196652', 'cui_str': 'Neurectomy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0228964', 'cui_str': 'Dorsal Nerve of Penis'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",46.0,0.0632284,Group 2a had more ejaculation controllability and lower Premature Ejaculation Diagnostic Tool scores than group 2b after the surgery (P < .001).,"[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Department of Nosocomial Infection Management, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Youpeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yongbiao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Nosocomial Infection Management, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 29859349@qq.com.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: zhuzhaohui316@163.com.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.01.319']
366,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND


We evaluated the association between etiology of maternal anemia and iron status throughout infancy.
METHODS


Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated.
RESULTS


Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status.
CONCLUSIONS


Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
367,32298501,High-protein meals require 30% additional insulin to prevent delayed postprandial hyperglycaemia.,"AIM


To determine the amount of additional insulin required for a high-protein meal to prevent postprandial hyperglycaemia in individuals with type 1 diabetes using insulin pump therapy.
METHODS


In this randomized cross-over study, 26 participants aged 8-40 years, HbA 1c  < 65 mmol/mol (8.1%), received a 50 g protein, 30 g carbohydrate, low-fat (< 1 g) breakfast drink over five consecutive days at home. A standard insulin dose (100%) was compared with additional doses of 115, 130, 145 and 160% for the protein, in randomized order. Doses were commenced 15-min pre-drink and delivered over 3 h using a combination bolus with 65% of the standard dose given up front. Postprandial glycaemia was assessed by 4 h of continuous glucose monitoring.
RESULTS


The 100% dosing resulted in postprandial hyperglycaemia. From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05). A 130% dose produced a mean (sd) glycaemic excursion that was 4.69 (2.42) mmol/l lower than control, returning to baseline by 4 h (P < 0.001). From 120 min, there was a significant increase in the risk of hypoglycaemia compared with control for 145% [odds ratio (OR) 25.4, 95% confidence interval (CI) 5.5-206; P < 0.001) and 160% (OR 103, 95% CI 19.2-993; P < 0.001). Some 81% (n = 21) of participants experienced hypoglycaemia following a 160% dose, whereas 58% (n = 15) experienced hypoglycaemia following a 145% dose. There were no hypoglycaemic events reported with 130%.
CONCLUSIONS


The addition of 30% more insulin to a standard dose for a high-protein meal, delivered using a combination bolus, improves postprandial glycaemia without increasing the risk of hypoglycaemia.",2020,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","['26 participants aged 8-40\xa0years, HbA 1c  <\xa065\xa0mmol/mol (8.1%), received a 50\xa0g protein', 'individuals with type 1 diabetes']","['30\xa0g carbohydrate, low-fat (<\xa01\xa0g) breakfast drink']","['risk of hypoglycaemia', 'postprandial hyperglycaemia', 'mean (sd) glycaemic excursion', 'Postprandial glycaemia', 'hypoglycaemia', 'delayed postprandial hyperglycaemia', 'postprandial glycaemic excursions', 'postprandial glycaemia', 'hypoglycaemic events']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",26.0,0.433075,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Paterson', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Smart', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Howley', 'Affiliation': 'School of Mathematical and Physical Sciences/Statistics, The University of Newcastle, Rankin Park, New South Wales, Australia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Pacific Private Clinic, Gold Coast, Australia.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Foskett', 'Affiliation': 'Insulin Pump Angels, Gold Coast, Australia.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14308']
368,32300055,Personalised yoga for burnout and traumatic stress in junior doctors.,"OBJECTIVES


Junior doctors are frequently exposed to occupational and traumatic stress, sometimes with tragic consequences. Mindfulness-based and fitness interventions are increasingly used to mitigate this, but have not been compared.We conducted a randomised, controlled pilot trial to assess the feasibility, acceptability and effectiveness of these interventions in junior doctors.
METHODS


We randomised participants (n=21) to weekly 1-hour sessions of personalised, trauma-informed yoga (n=10), with a 4-hour workshop, and eHealth homework; or group-format fitness (n=8) in an existing wellness programme, MDOK. Burnout, traumatic stress and suicidality were measured at baseline and 8 weeks.
RESULTS


Both interventions reduced burnout, and yoga increased compassion satisfaction within group on the Professional Quality of Life scale, without difference between groups on this measure.Personalised yoga significantly reduced depersonalisation (z=-1.99, p=0.05) compared with group fitness on the Maslach Burnout Inventory (MBI-HSS (MP)) and showed greater flexibility changes. Both interventions increased MBI Personal Accomplishment, with no changes in other self-report psychological or physiological metrics, including breath-counting.Participants doing one-to-one yoga rated it more highly overall (p=0.02) than group fitness, and reported it comparatively more beneficial for mental (p=0.01) and physical health (p=0.05). Face-to-face weekly sessions were 100% attended in yoga, but only 45% in fitness.
CONCLUSION


In this pilot trial, both yoga and fitness improved burnout, but trauma-informed yoga reduced depersonalisation in junior doctors more than group-format fitness. One-to-one yoga was better adhered than fitness, but was more resource intensive. Junior doctors need larger-scale comparative research of the effectiveness and implementation of individual, organisational and systemic mental health interventions.
TRIAL REGISTRATION NUMBER


ANZCTR 12618001467224.",2020,"Personalised yoga significantly reduced depersonalisation (z=-1.99, p=0.05) compared with group fitness on the Maslach Burnout Inventory (MBI-HSS (MP)) and showed greater flexibility changes.",['junior doctors'],"['Personalised yoga', 'personalised, trauma-informed yoga (n=10), with a 4-hour workshop, and eHealth homework; or group-format fitness (n=8) in an existing wellness programme, MDOK']","['Maslach Burnout Inventory (MBI-HSS (MP', 'compassion satisfaction', 'Burnout, traumatic stress and suicidality', 'flexibility changes', 'MBI Personal Accomplishment', 'Professional Quality of Life scale', 'self-report psychological or physiological metrics, including breath-counting', 'depersonalisation', 'beneficial for mental (p=0.01) and physical health', 'feasibility, acceptability and effectiveness']","[{'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0600651,"Personalised yoga significantly reduced depersonalisation (z=-1.99, p=0.05) compared with group fitness on the Maslach Burnout Inventory (MBI-HSS (MP)) and showed greater flexibility changes.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Brain and Mind Centre and Central Clinical School, The University of Sydney Faculty of Medicine and Health, Camperdown, New South Wales, Australia jfis8639@uni.sydney.edu.au.'}, {'ForeName': 'Loyola', 'Initials': 'L', 'LastName': 'McLean', 'Affiliation': 'Brain and Mind Centre and Westmead Psychotherapy Program for Complex Traumatic Disorders, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Richards', 'Affiliation': 'WellMD Centre, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre and Central Clinical School, The University of Sydney Faculty of Medicine and Health, Camperdown, New South Wales, Australia.'}]",Postgraduate medical journal,['10.1136/postgradmedj-2019-137413']
369,32302682,No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial.,"PURPOSE


Radiation therapy (RT) after breast-conserving surgery reduces locoregional recurrences and improves survival but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomized clinical trial initiated in 1991 and to report dose-volume data based on individual 3-dimensional treatment plans for organs at risk.
METHODS AND MATERIALS


The trial included 1187 patients with T1-2 N0 breast cancer randomized to postoperative tangential whole breast RT or no further treatment. The prescription dose to the clinical target volume was 48 to 54 Gy. We present 20-year follow-up on survival, cause of death, morbidity, and later malignancies. For a cohort of patients (n = 157) with accessible computed tomography-based 3-dimensional treatment plans in Dicom-RT format, dose-volume descriptors for organs at risk were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques.
RESULTS


The cumulative incidence of cardiac mortality was 12.4% in the control group and 13.0% in the RT group (P = .8). There was an increase in stroke mortality: 3.4% in the control group versus 6.7% in the RT group (P = .018). Incidences of contralateral breast cancer and lung cancer were similar between groups. The median D mean  (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1), and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0).
CONCLUSIONS


In this trial, serious late side effects of whole breast RT were limited and less than previously reported in large meta-analyses. We observed no increase in cardiac mortality in irradiated patients. Doses to the heart were a median D mean  of 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation.",2020,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"['1187 T1-2 N0 breast cancer patients randomised to', 'breast cancer patients after breast conserving surgery', 'organs at risk (OR']","['radiotherapy', 'Radiotherapy (RT', 'postoperative tangential whole breast radiotherapy or no further treatment', 'whole breast radiotherapy']","['stroke mortality', 'cardiac mortality', 'median D mean  (range) heart dose', 'cardiac mortality or morbidity', 'loco-regional recurrences and improves survival', 'Incidences of contra lateral breast cancer and lung cancer', 'cumulative incidence of cardiac mortality', 'survival, cause of death, morbidity and later malignancies']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1187.0,0.0509719,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"[{'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden. Electronic address: fredrika.killander@med.lu.se.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Regional Oncologic Centre West, Gothenburg, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, Kingś College London, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Haghanegi', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellen', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.003']
370,31414562,Association between individual cholesterol and proteinuria response and exposure to atorvastatin or rosuvastatin.,"AIM


The PLANET trials showed that atorvastatin 80 mg but not rosuvastatin at either 10 or 40 mg reduced urinary protein to creatinine ratio (UPCR) at similar effects on LDL-cholesterol. However, individual changes in both UPCR and LDL-cholesterol during treatment with these statins varied widely between patients. This inter-individual variability could not be explained by patients' physical or biochemical characteristics. We assessed whether the plasma concentrations of both statins were associated with LDL-cholesterol and UPCR response.
MATERIALS AND METHODS


The PLANET trials randomized patients with a UPCR of 500-5000 mg/g and fasting LDL-cholesterol >2.33 mmol/L to a 52-week treatment with atorvastatin 80 mg, rosuvastatin 10 mg or 40 mg. For the current analysis, patients with available samples at week 52 and treatment compliance >80% by pill count were included (N = 295). The main outcome measurements were percentage change in UPCR and absolute change in LDL-cholesterol (delta LDL) from baseline to week 52.
RESULTS


Median (interquartile range) plasma concentration at week 52 for atorvastatin 80 mg was 3.9 ng/mL (IQR: 2.1 to 8.7), for rosuvastatin 10 mg 1.0 ng/mL (IQR: 0.7 to 2.0) and for rosuvastatin 40 mg 3.5 ng/mL (IQR: 2.0 to 6.8). Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52 [rosuvastatin r = -0.40 (P < .001); atorvastatin r = -0.28 (P = .006)]. The plasma concentration of both statins did not correlate with UPCR change [rosuvastatin r = 0.07 (P = .30); atorvastatin r = 0.16 (P = .13)].
CONCLUSIONS


Individual variation in plasma concentrations of rosuvastatin and atorvastatin was associated with LDL-cholesterol changes in patients. The individual variation in UPCR change was not associated with the plasma concentration of both statins.",2019,Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52,['The PLANET trials randomized patients with a UPCR of 500-5000 mg/g and fasting LDL-cholesterol >2.33\u2009mmol/l to a 52-week treatment with'],"['atorvastatin', 'atorvastatin or rosuvastatin', 'atorvastatin 80 mg, rosuvastatin 10 mg or 40 mg', 'rosuvastatin', 'rosuvastatin and atorvastatin']","['percentage change in UPCR and absolute change in LDL-cholesterol (delta LDL', 'plasma concentration', 'LDL-cholesterol reductions', 'UPCR and LDL-cholesterol', 'LDL-cholesterol and UPCR response', 'plasma concentrations', 'Median (interquartile range) plasma concentration', 'LDL-cholesterol changes', 'urinary protein to creatinine ratio (UPCR']","[{'cui': 'C0080026', 'cui_str': 'Planets'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1124482', 'cui_str': 'atorvastatin 80 MG'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0266051,Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52,"[{'ForeName': 'Marjolein Y A M', 'Initials': 'MYAM', 'LastName': 'Kroonen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13849']
371,31525515,Mortality and Rate of Hospitalization in a Colonoscopy Screening Program From a Randomized Health Services Study.,"BACKGROUND & AIMS


It is difficult to quantify adverse events related to screening colonoscopy due to lack of valid and adequately powered comparison groups. We compared mortality and rate of unplanned hospitalizations among subjects who underwent screening colonoscopies within the Polish Colonoscopy Screening Program (PCSP) vs unscreened matched controls in Poland.
METHODS


Persons 55-64 years old living in the area covered by the PCSP from 2012 through 2015 were assigned in a (1:1) to a group invited for screening colonoscopy (n = 338,477) or a matched group that would be invited 5 years later (controls, n = 338,557). All subjects in the screening group were assigned proposed screening colonoscopy dates (actual dates when invitees confirmed or rescheduled colonoscopy) and those in the control group were assigned virtual dates corresponding to the matched individuals from the screening group. In the screening group, 55,390 subjects (16.4%) underwent screening colonoscopy. Mortality and hospitalization data were obtained from National Registries. We compared mortality and rate of hospitalization between the groups for defined intervals before and after colonoscopy date. Hospitalizations were divided into related and unrelated to colonoscopy based on ICD codes by 3 specialists. Our primary aim was to compare mortality and hospitalization 6 weeks before and 30 days following the actual or virtual date of colonoscopy in the screening or control group.
RESULTS


In the intent to treat analysis, overall there were no significant differences in mortality between the colonoscopy group and control group (0.22% vs 0.22%; risk difference less than .01%; 95% CI, decrease of 0.02% to 0.02%; P = .913). The overall rate of unplanned hospitalization was significantly higher for the colonoscopy group (2.39% vs 2.31% for the control group; risk difference, 0.08%; 95% CI, 0.01%-0.15%; P=.026) for the entire observation period. This was due to the higher rate of hospitalizations after screening (1.10% vs 1.01% for the control group; risk difference, 0.09%; 95% CI, 0.04%-0.14%; P < .001) including higher proportion of hospitalizations that were assessed as related to colonoscopy (0.24% vs 0.22% for the control group; risk difference, 0.02%; 95% CI, 0.00%-0.05%; P = .046). In the per-protocol analysis, the overall rate of hospitalizations did not differ significantly between control and screening colonoscopy groups (1.87% vs 1.90%; P=.709). However, screening colonoscopy did increase rates of related hospitalizations after the date of screening (from 0.14% to 0.31%; P < .001).
CONCLUSIONS


In an analysis of data from the PCSP, we found high-quality evidence that colonoscopy as a screening intervention does not increase mortality before or after colonoscopy. However, it may be associated with a small but significant increase in unplanned hospitalizations, especially after the colonoscopy is completed.",2020,"In the per-protocol analysis, the overall rate of hospitalizations did not differ significantly between control and screening colonoscopy groups (1.87% vs 1.90%; P=.709).","['55,390 subjects (16.4%) underwent screening colonoscopy', 'subjects who underwent screening colonoscopies within the Polish Colonoscopy Screening Program (PCSP) vs unscreened matched controls in Poland', 'Persons 55-64 years old living in the area covered by the PCSP from 2012 through 2015 were assigned in a (1:1) to a group invited for']","['screening colonoscopy (n=338,477) or a matched group that would be invited 5 years later (controls, n=338,557', 'screening colonoscopy dates (actual dates when invitees confirmed or rescheduled colonoscopy']","['mortality and rate of hospitalization', 'mortality', 'rate of hospitalizations', 'Mortality and hospitalization data', 'overall rate of hospitalizations', 'unplanned hospitalizations', 'overall rate of unplanned hospitalization', 'Mortality and Rate of Hospitalization', 'mortality and rate of unplanned hospitalizations']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2015.0,0.0592815,"In the per-protocol analysis, the overall rate of hospitalizations did not differ significantly between control and screening colonoscopy groups (1.87% vs 1.90%; P=.709).","[{'ForeName': 'Jarek', 'Initials': 'J', 'LastName': 'Kobiela', 'Affiliation': 'Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, Gdansk, Poland; Department of Cancer Prevention, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Spychalski', 'Affiliation': 'Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, Gdansk, Poland. Electronic address: piotr.spychalski@gumed.edu.pl.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Pisera', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Nastazja', 'Initials': 'N', 'LastName': 'Pilonis', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Rupinski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bugajski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Kaminski', 'Affiliation': 'Department of Cancer Prevention, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland; Department of Oncological Gastroenterology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.09.010']
372,31146544,Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.,"BACKGROUND


Previously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab.
METHODS


Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs.
RESULTS


Of 383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3%) remained in the study, all received 140 mg for ≥1 year. Median (Q1, Q3) exposure (70 or 140 mg) for all patients enrolled was 3.2 (1.3, 3.4) years. The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain. Exposure-adjusted serious adverse event rates were 4.2/100 patient-years. There was no increase in cardiovascular events over time.
CONCLUSIONS


In this long-term study of a CGRP-receptor antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of adverse events consistent with shorter-term placebo-controlled studies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01952574.",2019,"The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain.","['383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3', 'Adult patients with episodic migraine enrolled in the', 'Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study', 'five-year open-label extension study in episodic migraine']","['erenumab', 'open-label treatment phase initially received 70\u2009mg erenumab monthly', 'placebo']","['cardiovascular events', 'viral upper respiratory tract infection, sinusitis, influenza, and back pain', 'monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0339916', 'cui_str': 'Viral upper respiratory tract infection (disorder)'}, {'cui': 'C0037199', 'cui_str': 'Sinus Infections'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0518766'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",383.0,0.0357358,"The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain.","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Rippon', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Chia', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419854082']
373,29624592,Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers.,"BACKGROUND


Cholera is an acute voluminous dehydrating diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and occasionally O139. A growing body of evidence indicates that immune responses targeting the O-specific polysaccharide (OSP) of V. cholerae are involved in mediating protection against cholera. We therefore assessed whether antibody responses against OSP occur after vaccination with live attenuated oral cholera vaccine CVD 103-HgR, and whether such responses correlate with protection against cholera.
METHODOLOGY


We assessed adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination.
PRINCIPAL FINDINGS


Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination. There was significant correlation between anti-OSP and vibriocidal antibody responses. IgM and IgA anti-OSP responses on day 10 following vaccination were associated with lower post-challenge stool volume (r = -0.44, P = 0.002; r = -0.36, P = 0.01; respectively), and none of 27 vaccinees who developed a ≥1.5 fold increase in any antibody isotype targeting OSP on day 10 following vaccination compared to baseline developed moderate or severe cholera following experimental challenge, while 5 of 19 who did not develop such anti-OSP responses did (P = 0.01).
CONCLUSION


Oral vaccination with live attenuated cholera vaccine CVD 103-HgR induces antibodies that target V. cholerae OSP, and these anti-OSP responses correlate with protection against diarrhea following experimental challenge with V. cholerae O1.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01895855.",2018,"PRINCIPAL FINDINGS


Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination.","['North American volunteers', 'adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of']","['oral cholera vaccine CVD', 'oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination', 'Anti-O-specific polysaccharide (OSP']","['anti-OSP and vibriocidal antibody responses', 'antibody isotype targeting OSP', 'serum IgM and IgA anti-OSP and vibriocidal antibody responses', 'IgM and IgA anti-OSP responses', 'moderate or severe cholera']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0961644', 'cui_str': 'cholera vaccine CVD 103-HgR'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443008', 'cui_str': 'Inaba'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0069180', 'cui_str': 'O Antigen, Bacterial'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}]",,0.428102,"PRINCIPAL FINDINGS


Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination.","[{'ForeName': 'Kamrul', 'Initials': 'K', 'LastName': 'Islam', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Motaher', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Mayo Smith', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Richelle C', 'Initials': 'RC', 'LastName': 'Charles', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Taufiqur Rahman', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Pavol', 'Initials': 'P', 'LastName': 'Kováč', 'Affiliation': 'National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Regina C', 'Initials': 'RC', 'LastName': 'LaRocque', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Calderwood', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States of America.'}, {'ForeName': 'Wilbur H', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Haney', 'Affiliation': 'PaxVax, Inc., Redwood City, California, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'PaxVax, Inc., Redwood City, California, United States of America.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Lyon', 'Affiliation': 'Vaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States of America.""}, {'ForeName': 'Myron M', 'Initials': 'MM', 'LastName': 'Levine', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gurwith', 'Affiliation': 'PaxVax, Inc., Redwood City, California, United States of America.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Harris', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Ryan', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0006376']
374,32304676,"Impact of sugar taxes and front-of-package nutrition labels on purchases of protein, calcium and fibre.","Taxes and front-of-package (FOP) labels can be effective interventions for reducing consumption of sugar, saturated fat, and sodium; however, few studies have examined their impact on intake of 'positive' nutrients. The current study explored the impact of sugar taxes and FOP labels on the protein, calcium and fibre density of snack food purchases. A total of 3584 Canadians aged 13 years and older participated in an experimental marketplace using a 3 × 8 between-within group experiment. Participants received $5 and viewed images of 20 snack food products available for purchase. Participants were randomized to one of five FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered). Upon conclusion, participants received the product and any change from one of the purchasing tasks. The results indicate that participants purchased snack foods with higher fibre density when either sugar tax was applied (+0.1 g/100 kcal) compared to no tax, and when they were assigned to see the multiple traffic light (+0.4 g/100 kcal) or health star rating (+0.3 g/100 kcal) FOP labels, compared to no FOP label. There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions. Overall, the findings suggest that as consumers respond to tax or labelling policies by moving away from sugars, sodium, and saturated fat, there may be no downside-or even an increase-in 'positive' nutrient density.",2020,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,['3584 Canadians aged 13\u202fyears and older participated in an experimental marketplace using a 3\u202f×\u202f8 between-within group experiment'],"['sugar taxes and front-of-package nutrition labels', 'multiple traffic light (+0.4\u202fg/100\u202fkcal) or health star rating (+0.3\u202fg/100\u202fkcal) FOP labels', 'sugar taxes and FOP labels', 'Taxes and front-of-package (FOP) labels', 'FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered']","['purchases of protein, calcium and fibre']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",3584.0,0.0287178,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,"[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: rbacton@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: david.hammond@uwaterloo.ca.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106091']
375,31754070,"Supervised, Multimodal Exercise: The Chemotherapy Supportive Therapy That Almost Does It All.","This commentary describes and places the results into context for the recent OptiTrain trial, a three‐arm randomized trial of two different exercise interventions versus usual care on rates of chemotherapy completion, hospitalization, and hematological toxicity.",2020,"This commentary describes and places the results into context for the recent OptiTrain trial, a three‐arm randomized trial of two different exercise interventions versus usual care on rates of chemotherapy completion, hospitalization, and hematological toxicity.",[],"['Chemotherapy Supportive Therapy', 'Multimodal Exercise', 'exercise interventions versus usual care']","['rates of chemotherapy completion, hospitalization, and hematological toxicity']",[],"[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0312269,"This commentary describes and places the results into context for the recent OptiTrain trial, a three‐arm randomized trial of two different exercise interventions versus usual care on rates of chemotherapy completion, hospitalization, and hematological toxicity.","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'Department of Biomedical Engineering, University of Alberta, Edmonton, Canada.'}]",The oncologist,['10.1634/theoncologist.2019-0628']
376,31537107,"Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.","BACKGROUND


Ubrogepant is a novel, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. This trial evaluated the safety and tolerability of ubrogepant, focusing on hepatic safety, when administered intermittently with high-frequency dosing to healthy participants.
METHODS


In this phase 1, multicenter, double-blind, parallel-group trial, healthy adults (age 18-50 years) were randomized 1:1 to placebo or ubrogepant. Ubrogepant was dosed at 100 mg (2 × 50 mg tablets) on 2 consecutive days followed by 2 consecutive days of placebo, alternating for 8 weeks. Primary outcome measures were safety and tolerability.
RESULTS


Of participants randomized (n = 518), 516 were included in the safety population (n = 260 placebo; n = 256 ubrogepant). Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants. The most common was headache (10% placebo; 11% ubrogepant). Overall, seven cases of alanine aminotransferase and/or aspartate aminotransferase levels ≥ 3 × the upper limit of normal (five placebo, two ubrogepant) were reported and adjudicated by a panel of independent liver experts blinded to treatment. Four cases were judged unlikely related to treatment. Two cases (one placebo, one ubrogepant) were judged possibly related, and one (ubrogepant) probably related. Alanine aminotransferase increases to ≥ 3 × the upper limit of normal in the two ubrogepant cases (possibly or probably related) were transient and resolved with continued dosing; both cases were asymptomatic, with no concurrent bilirubin elevation.
CONCLUSION


Ubrogepant was well tolerated following intermittent, high-frequency dosing in healthy participants, with no clinically relevant signal of hepatotoxicity.
TRIAL REGISTRATION


NA.",2019,Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants.,"['healthy adults (age 18-50 years', ' 516 were included in the safety population (n\u2009=\u2009260 placebo; n\u2009=\u2009256 ubrogepant', 'Of participants randomized (n\u2009=\u2009518', 'healthy participants', 'healthy adults']","['placebo', 'placebo or ubrogepant']","['alanine aminotransferase and/or aspartate aminotransferase levels', 'headache', 'Alanine aminotransferase', 'Safety and tolerability', 'safety and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",516.0,0.558061,Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Watkins', 'Affiliation': 'Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Girma', 'Initials': 'G', 'LastName': 'Ayele', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Severt', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419869918']
377,32300812,"Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.0175443,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa208']
378,32303765,Estradiol Valerate in COC Has More Favorable Inflammatory Profile Than Synthetic Ethinyl Estradiol: A Randomized Trial.,"CONTEXT


Combined oral contraceptives (COCs) alter inflammatory status and lipid metabolism. Whether different estrogens have different effects is poorly understood.
OBJECTIVE


We compared the effects of COCs containing ethinyl estradiol (EE) or estradiol valerate (EV) and dienogest (DNG) with those containing DNG only on inflammation and lipid metabolism.
DESIGN


Randomized, controlled, open-label clinical trial.
SETTING


Two-center study in Helsinki and Oulu University Hospitals.
PARTICIPANTS


Fifty-nine healthy, young, nonsmoking women with regular menstrual cycles. Age, body mass index, and waist-to-hip ratio were comparable in all study groups at the beginning. Fifty-six women completed the study (EV + DNG, n = 20; EE + DNG, n = 19; DNG only, n = 17).
INTERVENTIONS


Nine-week continuous use of COCs containing either EV + DNG or EE + DNG, or DNG only as control.
MAIN OUTCOME MEASURES


Parameters of chronic inflammation (high-sensitivity C-reactive protein [hs-CRP], and pentraxin 3 [PTX-3]) and lipid profile (high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, and total cholesterol).
RESULTS


Serum hs-CRP increased after 9-week use of EE + DNG (mean change ± standard deviation 1.10 ± 2.11 mg/L) compared with EV + DNG (-0.06 ± 0.97 mg/L, P = 0.001) or DNG only (0.13 ± 0.68 mg/L, P = 0.021). Also, PTX-3 increased in the EE + DNG group compared with EV + DNG and DNG-only groups (P = 0.017 and P = 0.003, respectively). In the EE + DNG group, HDL and triglycerides increased compared with other groups (HDL: EE + DNG 0.20 ± 0.24 mmol/L vs EV + DNG 0.02 ± 0.20 mmol/L [P = 0.002] vs DNG 0.02 ± 0.18 mmol/L [P = 0.002]; triglycerides: EE + DNG 0.45 ± 0.21 mmol/L vs EV + DNG 0.18 ± 0.36 mmol/L [P = 0.003] vs DNG 0.06 ± 0.18 mmol/L [P < 0.001]).
CONCLUSIONS


EV + DNG and DNG only had a neutral effect on inflammation and lipids, while EE + DNG increased both hs-CRP and PTX-3 levels as well as triglycerides and HDL.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02352090.",2020,"In the EE+DNG group, HDL and triglycerides increased compared with other groups (HDL: EE+DNG 0.20±0.24 mmol/L vs. EV+DNG 0.02±0.20 mmol/L[p=0.002] vs. DNG 0.02±0.18 mmol/L[p=0.002]; triglycerides: EE+DNG 0.45±0.21 mmol/L vs. EV+DNG 0.18±0.36 mmol/L[p=0.003] vs. DNG 0.06±0.18 mmol/L[p<0.001]).
","['Fifty-six women completed the study (EV+DNG, n=20; EE+DNG, n=19; DNG only, n=17', 'Two-center study in Helsinki and Oulu University Hospitals', 'Fifty-nine healthy, young, non-smoking women with regular menstrual cycles']","['oral contraceptives (COCs', 'COCs containing either EV+DNG or EE+DNG, or DNG only as control', 'COCs containing ethinyl estradiol (EE) or estradiol valerate (EV) and dienogest (DNG) with those containing DNG', 'EV+DNG', 'synthetic ethinyl estradiol', 'Estradiol valerate']","['chronic inflammation (high-sensitivity C-reactive protein, hs-CRP and pentraxin 3, PTX-3) and lipid profile (HDL, LDL, triglycerides and total cholesterol', 'Age, BMI and waist-to-hip ratio', 'PTX-3', 'Serum hs-CRP', 'HDL and triglycerides']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}]","[{'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",59.0,0.0736565,"In the EE+DNG group, HDL and triglycerides increased compared with other groups (HDL: EE+DNG 0.20±0.24 mmol/L vs. EV+DNG 0.02±0.20 mmol/L[p=0.002] vs. DNG 0.02±0.18 mmol/L[p=0.002]; triglycerides: EE+DNG 0.45±0.21 mmol/L vs. EV+DNG 0.18±0.36 mmol/L[p=0.003] vs. DNG 0.06±0.18 mmol/L[p<0.001]).
","[{'ForeName': 'Marika H', 'Initials': 'MH', 'LastName': 'Kangasniemi', 'Affiliation': 'Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Haverinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kaisu', 'Initials': 'K', 'LastName': 'Luiro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'J Kalervo', 'Initials': 'JK', 'LastName': 'Hiltunen', 'Affiliation': 'Faculty of Biochemistry and Molecular Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Elina K', 'Initials': 'EK', 'LastName': 'Komsi', 'Affiliation': 'Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Riikka K', 'Initials': 'RK', 'LastName': 'Arffman', 'Affiliation': 'Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha S', 'Initials': 'JS', 'LastName': 'Tapanainen', 'Affiliation': 'Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Terhi T', 'Initials': 'TT', 'LastName': 'Piltonen', 'Affiliation': 'Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa186']
379,31407845,"Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naïve Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial.","AIMS


To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with its individual components in Japanese people with type 2 diabetes (T2D) uncontrolled on an oral antidiabetic drug (OAD).
MATERIALS AND METHODS


This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD. The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
RESULTS


After 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide: estimated treatment differences were -6.91 mmol/mol (95% confidence interval [CI] -8.18; -5.64) and -5.30 mmol/mol (95% CI -6.58; -4.03), confirming non-inferiority of IDegLira to degludec and superiority of IDegLira to liraglutide (P < .0001 for both [primary endpoint]). Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001). Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48 [95% CI 0.35; 0.68]; P < .0001), but higher versus liraglutide (rate ratio 37.58 [95% CI 19.80; 71.31]; P < .0001). Mean daily total insulin dose was lower with IDegLira (27.7 U) versus degludec (34.8 U; P < .0001). Overall adverse event (AE) rates were similar. In total, 34.9%, 22.9% and 41.8% of IDegLira-, degludec- and liraglutide-treated participants experienced gastrointestinal AEs.
CONCLUSION


IDegLira was superior to degludec and liraglutide in terms of HbA1c reduction and superior to degludec in terms of body weight change and rates of hypoglycaemia in Japanese people with T2D.",2019,Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48,"['insulin-naïve Japanese patients with type 2 diabetes', 'Japanese people with T2D', 'Japanese people with type 2 diabetes (T2D) uncontrolled on an oral antidiabetic drug (OAD']","['IDegLira, liraglutide 1.8 mg or degludec', 'liraglutide', 'insulin degludec/liraglutide (IDegLira', 'fixed-ratio combination of insulin degludec and liraglutide (IDegLira', 'insulin degludec and liraglutide', 'mmol/mol ']","['Mean body weight changes', 'Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira', 'Mean daily total insulin dose', 'gastrointestinal AEs', 'glycated haemoglobin (HbA1c', 'body weight change and rates of hypoglycaemia', 'Overall adverse event (AE) rates']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",819.0,0.206168,Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Tanizawa', 'Affiliation': 'Graduate School of Medicine, Yamaguchi University, Ube, Japan.'}, {'ForeName': 'Bue', 'Initials': 'B', 'LastName': 'Ross Agner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Mattis', 'Initials': 'M', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13856']
380,31407856,Effects of the sodium-glucose co-transporter-2 inhibitor dapagliflozin on estimated plasma volume in patients with type 2 diabetes.,"AIMS


To compare the effects of the sodium-glucose co-transporter-2 (SGLT2) inhibitor dapagliflozin on estimated (ePV) and measured plasma volume (mPV) and to characterize the effects of dapagliflozin on ePV in a broad population of patients with type 2 diabetes.
MATERIALS AND METHODS


The Strauss formula was used to calculate changes in ePV. Change in plasma volume measured with  125  I-human serum albumin (mPV) was compared with change in ePV in 10 patients with type 2 diabetes randomized to dapagliflozin 10 mg/d or placebo. Subsequently, changes in ePV were measured in a pooled database of 13 phase 2b/3 placebo-controlled clinical trials involving 4533 patients with type 2 diabetes who were randomized to dapagliflozin 10 mg daily or matched placebo.
RESULTS


The median change in ePV was similar to the median change in mPV (-9.4% and -9.0%) during dapagliflozin treatment. In the pooled analysis of clinical trials, dapagliflozin decreased ePV by 9.6% (95% confidence interval 9.0 to 10.2) compared to placebo after 24 weeks. This effect was consistent in various patient subgroups, including subgroups with or without diuretic use or established cardiovascular disease.
CONCLUSIONS


ePV may be used as a proxy to assess changes in plasma volume during dapagliflozin treatment. Dapagliflozin consistently decreased ePV compared to placebo in a broad population of patients with type 2 diabetes.",2019,"In the pooled analysis of clinical trials, dapagliflozin compared to placebo decreased ePV by 9.6 % (95% CI: 9.0 to 10.2%) after 24 weeks.","['10 patients with type 2 diabetes randomized to', '4533 patients with type 2 diabetes', 'various patient subgroups including subgroups with or without diuretic use or established cardiovascular disease', 'patients with type 2 diabetes']","['dapagliflozin 10 mg daily or matched placebo', 'placebo', 'I-human serum albumin', 'dapagliflozin', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors']","['ePV', 'estimated plasma volume (ePV', 'plasma volume', 'estimated plasma volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}]",4533.0,0.0924018,"In the pooled analysis of clinical trials, dapagliflozin compared to placebo decreased ePV by 9.6 % (95% CI: 9.0 to 10.2%) after 24 weeks.","[{'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, Astra Zeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Cardiovascular, Renal and Metabolism Translational Medicines Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions, Raleigh, North Carolina.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, IMED Biotech Unit, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13855']
381,31702876,Effect of seasonal influenza vaccination on influenza symptom severity among children in Hutterite communities: Follow-up study of a randomized trial.,"BACKGROUND


We investigated whether influenza vaccination reduces symptom severity among children who develop laboratory-confirmed influenza, and whether this association differed between influenza vaccine formulations.
METHODS


We performed a retrospective cohort study using data from two blinded cluster randomized control trials of influenza vaccines in Hutterite colonies. In trial 1, children received trivalent inactivated influenza vaccine (TIV) or hepatitis A vaccine. In trial 2, children received trivalent live attenuated (TLAIV) or TIV. We assessed four outcomes (total number of symptoms, number of respiratory symptoms, number of systemic symptoms, and duration of symptoms) among children with PCR-confirmed influenza. We utilized two-sample t tests to quantify the relationship between vaccine group and outcome. We performed multivariable strain-specific analyses, controlling for age and season.
RESULTS


TIV vs. Hep A vaccine: Among vaccinated children, 200 confirmed influenza infections were observed across 3014 person-seasons. Vaccine type (TIV vs. Hep A vaccine) did not significantly affect the number of respiratory or systemic symptoms, nor duration of symptoms (P > .05). TLAIV vs. TIV: Among 1186 children who received a study vaccine, 166 confirmed influenza infections were observed. TLAIV recipients experienced fewer total, respiratory, and systemic symptoms compared to TIV recipients (P < .05 for all). TLAIV-associated attenuation of symptom severity was observed in influenza B or A/H1N1 infections, but not H3.
CONCLUSIONS


Seasonal influenza vaccine did not consistently attenuate symptom severity in the context of vaccine failure; however, TLAIV offered superior severity attenuation compared to TIV. Our results challenge the dictum that influenza vaccine reduces the severity of symptoms even when the vaccine fails to prevent influenza.",2020,"TLAIV-associated attenuation of symptom severity was observed in influenza B or A/H1N1 infections, but not H3.
","['children in Hutterite communities', 'children who develop laboratory-confirmed influenza', 'Hutterite colonies', '1186 children who received a study vaccine, 166 confirmed influenza infections were observed']","['trivalent live attenuated (TLAIV) or TIV', 'seasonal influenza vaccination', 'influenza vaccines', 'TLAIV vs. TIV', 'vaccine', 'influenza vaccination', 'Vaccine type (TIV vs. Hep A vaccine', 'trivalent inactivated influenza vaccine (TIV) or hepatitis A vaccine', 'influenza vaccine']","['total, respiratory, and systemic symptoms', 'outcomes (total number of symptoms, number of respiratory symptoms, number of systemic symptoms, and duration of symptoms', 'number of respiratory or systemic symptoms, nor duration of symptoms', 'influenza symptom severity', 'influenza infections', 'TLAIV-associated attenuation of symptom severity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]","[{'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0170300', 'cui_str': 'Hepatovirus Vaccines'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1186.0,0.244087,"TLAIV-associated attenuation of symptom severity was observed in influenza B or A/H1N1 infections, but not H3.
","[{'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Brent', 'Affiliation': 'Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Pullenayegum', 'Affiliation': 'The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Russell', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, The University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Departments of Pathology and Molecular Medicine and Health Research Evidence and Impact, Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.'}]",Influenza and other respiratory viruses,['10.1111/irv.12689']
382,32299222,Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study.,"BACKGROUND


Heart failure with reduced ejection fraction (HFrEF) is characterized by blunting of the positive relationship between heart rate and left ventricular (LV) contractility known as the force-frequency relationship (FFR). We have previously described that tailoring the rate-response programming of cardiac implantable electronic devices in patients with HFrEF on the basis of individual noninvasive FFR data acutely improves exercise capacity. We aimed to examine whether using FFR data to tailor heart rate response in patients with HFrEF with cardiac implantable electronic devices favorably influences exercise capacity and LV function 6 months later.
METHODS


We conducted a single-center, double-blind, randomized, parallel-group trial in patients with stable symptomatic HFrEF taking optimal guideline-directed medical therapy and with a cardiac implantable electronic device (cardiac resynchronization therapy or implantable cardioverter-defibrillator). Participants were randomized on a 1:1 basis between tailored rate-response programming on the basis of individual FFR data and conventional age-guided rate-response programming. The primary outcome measure was change in walk time on a treadmill walk test. Secondary outcomes included changes in LV systolic function, peak oxygen consumption, and quality of life.
RESULTS


We randomized 83 patients with a mean±SD age 74.6±8.7 years and LV ejection fraction 35.2±10.5. Mean change in exercise time at 6 months was 75.4 (95% CI, 23.4 to 127.5) seconds for FFR-guided rate-adaptive pacing and 3.1 (95% CI, -44.1 to 50.3) seconds for conventional settings (analysis of covariance;  P =0.044 between groups) despite lower peak mean±SD heart rates (98.6±19.4 versus 112.0±20.3 beats per minute). FFR-guided heart rate settings had no adverse effect on LV structure or function, whereas conventional settings were associated with a reduction in LV ejection fraction.
CONCLUSIONS


In this phase II study, FFR-guided rate-response programming determined using a reproducible, noninvasive method appears to improve exercise time and limit changes to LV function in people with HFrEF and cardiac implantable electronic devices. Work is ongoing to confirm our findings in a multicenter setting and on longer-term clinical outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02964650.",2020,(-44.1 to 50.3) seconds for conventional settings (ANCOVA p=0.044 between groups),"['patients with stable symptomatic HFrEF, taking optimal guideline-directed medical therapy and with a', 'people with HFrEF and CIEDs', 'People with Cardiac Implantable Electronic Devices and Heart Failure', '83 patients with a mean ± SD age 74.6 ± 8.7 years, and mean LV ejection fraction (LVEF) 35.2 ± 10.5', 'HFrEF patients with CIEDs', ""patients with HFrEF based upon individual's non-invasive FFR data acutely improves exercise capacity""]","['CIED (cardiac resynchronisation therapy (CRT) or implantable cardioverter defibrillator (ICD', 'Personalised Rate-Response Programming Improves Exercise Tolerance', ""tailored rate-response programming based upon individuals' FFR data, and conventional age-guided rate-response programming"", 'cardiac implantable electronic devices (CIED']","['change in walk time on a treadmill walk test', 'changes in LV systolic function, peak oxygen consumption and quality of life', 'heart rate (HR) and left ventricular (LV) contractility', 'Mean (95%CI) change in exercise time', 'peak mean (± SD) heart rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C3875470', 'cui_str': 'Improved exercise tolerance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}]",83.0,0.320751,(-44.1 to 50.3) seconds for conventional settings (ANCOVA p=0.044 between groups),"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gierula', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Lowry', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Paton', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Cole', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Rowenna', 'Initials': 'R', 'LastName': 'Byrom', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Aaron O', 'Initials': 'AO', 'LastName': 'Koshy', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Chumun', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Lorraine C', 'Initials': 'LC', 'LastName': 'Kearney', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Straw', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'T Scott', 'Initials': 'TS', 'LastName': 'Bowen', 'Affiliation': 'Faculty of Biological Sciences, School of Medicine (T.S.B.), University of Leeds, United Kingdom.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Cubbon', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Anne-Maree', 'Initials': 'AM', 'LastName': 'Keenan', 'Affiliation': 'School of Healthcare (A.M.K.), University of Leeds, United Kingdom.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': 'Leeds Institute of Clinical Trials Research (D.D.S), University of Leeds, United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Kearney', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}, {'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine (J.G., J.E.L., M.F.P., C.A.C., R.B., A.O.K., H.C., L.C.K., S.S., R.M.C., M.T.K., K.K.W.), University of Leeds, United Kingdom.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.045066']
383,31507100,A pilot study on high amplitude low frequency-music impulse stimulation as an add-on treatment for depression.,"OBJECTIVE


High Amplitude Low Frequency-Music Impulse Stimulation (HALF-MIS) is a form of Vagus Nerve Stimulation (VNS). The aim of the study was to determine the feasibility, efficacy, and potential side effects of HALF-MIS, used as an add-on treatment for depression.
METHODS


This is an open randomized controlled pilot study. Patients with depressive disorder were randomly allocated to either a HALF-MIS group with eight add-on HALF-MIS sessions (over a period of 3-4 weeks) or a control group which received treatment as usual. Seated in a specially designed chair() embedded with a transducer, their central nervous system was stimulated through the abdomen, () using music and vibration. Hamilton rating was performed. Side effects were registered.
RESULTS


Eighteen patients were randomized to the add-on treatment and 20 patients to the control group. Both groups show in Hamilton Depression Rating Scale (HDRS)-17 and in HDRS-6, although the HALF-MIS group had a greater decline of symptoms. This was a significant difference in intergroup analysis (p = .011, CI 95% for the HALF-MIS group 3.0588-8.5327 and CI 95% for the control group 0.2384-3.0). The (HDRS)-6 difference was also significant (p = .020, CI 95% for the HALF-MIS group 1.5911-5.0487 and for the control group -0.297 to 1.7058). No side effects were observed.
CONCLUSIONS


High Amplitude Low Frequency-Music Impulse Stimulation treatment seems to give beneficial effect as an add-on treatment for depression. HALF-MIS appears to be a safe and effective add-on treatment for depression.",2019,"This was a significant difference in intergroup analysis (p = .011, CI 95% for the HALF-MIS group 3.0588-8.5327 and CI 95% for the control group 0.2384-3.0).","['Eighteen patients', 'Patients with depressive disorder']","['High Amplitude Low Frequency-Music Impulse Stimulation (HALF-MIS', 'HALF-MIS group with eight add-on HALF-MIS sessions', 'HALF-MIS']","['feasibility, efficacy', 'Side effects', 'side effects', 'Hamilton Depression Rating Scale (HDRS)-17 and in HDRS-6']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",,0.0382608,"This was a significant difference in intergroup analysis (p = .011, CI 95% for the HALF-MIS group 3.0588-8.5327 and CI 95% for the control group 0.2384-3.0).","[{'ForeName': 'Gudrun Agusta', 'Initials': 'GA', 'LastName': 'Sigurdardóttir', 'Affiliation': 'Psychiatric Centre Amager, Copenhagen University Hospital, Copenhagen S, Denmark.'}, {'ForeName': 'Peter Michael', 'Initials': 'PM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neurology, Holbaek Hospital, Sjaelland, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Rønager', 'Affiliation': 'Department of Neurology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'August Gabriel', 'Initials': 'AG', 'LastName': 'Wang', 'Affiliation': 'Psychiatric Centre Amager, Copenhagen University Hospital, Copenhagen S, Denmark.'}]",Brain and behavior,['10.1002/brb3.1399']
384,31087060,Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model.,"CONTEXT


We previously developed and validated an inexpensive and parsimonious prediction model of 2-year all-cause mortality in real-life patients with type 2 diabetes.
OBJECTIVE


This model, now named ENFORCE (EstimatioN oF mORtality risk in type 2 diabetiC patiEnts), was investigated in terms of (i) prediction performance at 6 years, a more clinically useful time-horizon; (ii) further validation in an independent sample; and (iii) performance comparison in a real-life vs a clinical trial setting.
DESIGN


Observational prospective randomized clinical trial.
SETTING


White patients with type 2 diabetes.
PATIENTS


Gargano Mortality Study (GMS; n = 1019), Foggia Mortality Study (FMS; n = 1045), and Pisa Mortality Study (PMS; n = 972) as real-life samples and the standard glycemic arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) clinical trial (n = 3150).
MAIN OUTCOME MEASURE


The endpoint was all-cause mortality. Prediction accuracy and calibration were estimated to assess the model's performances.
RESULTS


ENFORCE yielded 6-year mortality C-statistics of 0.79, 0.78, and 0.75 in GMS, FMS, and PMS, respectively (P heterogeneity = 0.71). Pooling the three cohorts showed a 6-year mortality C-statistic of 0.80. In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value significantly lower than that obtained in the pooled real-life samples (P < 0.0001). This difference resembles that observed with other models comparing real-life vs clinical trial settings, thus suggesting it is a true, replicable phenomenon.
CONCLUSIONS


The time horizon of ENFORCE has been extended to 6 years and validated in three independent samples. ENFORCE is a free and user-friendly risk calculator of all-cause mortality in white patients with type 2 diabetes from a real-life setting.",2019,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","['White patients with type 2 diabetes', 'real-life type 2 diabetic patients', 'type2 diabetiC patiEnts (ENFORCE']",[],"['cause mortality', 'Foggia Mortality Study (FMS', '6-year mortality C-statistics', 'Pisa Mortality Study (PMS; n=972) as real-life samples and the standard glycemic arm of the ACCORD clinical trial (n=3150']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",3150.0,0.0556168,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Copetti', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Scarale', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Menzaghi', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'De Cosmo', 'Affiliation': 'Department of Clinical Sciences, Fondazione IRCCS ""Casa Sollievo Della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Garofolo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Sorrentino', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lamacchia', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Penno', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Trischitta', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00215']
385,31282028,Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial.,"AIM


Glucagon-like peptide-1 receptor agonist (GLP-1RA) and insulin combination therapy is an effective treatment option for type 2 diabetes, but long-term data are lacking. The aim was to assess the long-term efficacy of the GLP-1RA liraglutide in subgroups by insulin use in the LEADER trial.
MATERIALS AND METHODS


LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years. We analyzed CV events, metabolic parameters and hypoglycaemia post hoc in three subgroups by baseline insulin use (basal-only insulin, other insulin or no insulin). Insulin was a non-random treatment allocation as part of standard of care therapy.
RESULTS


At baseline, 5171 (55%) patients were not receiving insulin, 3159 (34%) were receiving basal-only insulin and 1010 (11%) other insulins. Insulin users had a longer diabetes duration and slightly worse glycaemic control (HbA1c) than the no-insulin subgroup. Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001), and severe hypoglycaemia rate in the basal-only insulin subgroup. The need for insulin was less with liraglutide. CV risk reduction with liraglutide was similar to the main trial results in the basal-only and no-insulin subgroups.
CONCLUSIONS


In patients on insulin, liraglutide improved glycaemic control, weight and need for insulin versus placebo, for at least 36 months with no increased risk of severe hypoglycaemia, while maintaining CV safety/efficacy, supporting the combination of liraglutide and insulin for management of type 2 diabetes.",2019,"Liraglutide reduced HbA1c and weight vs placebo in all three subgroups (P < 0.001), and severe hypoglycemia rate in the basal-only insulin subgroup.","['9340 patients with type 2 diabetes and high risk for CV disease, for up to 5 years']","['combined insulin and GLP-1 therapy', 'placebo', 'GLP-1RA liraglutide', 'placebo (plus standard of care therapy', 'Liraglutide', 'liraglutide', 'Glucagon-like peptide-1 receptor agonist (GLP-1RA) and insulin combination therapy', 'liraglutide and insulin', 'insulin, liraglutide']","['cardiovascular (CV) safety and efficacy', 'glycemic control, weight and need for insulin', 'risk of severe hypoglycemia', 'HbA1c and weight', 'CV safety/efficacy', 'longer diabetes duration', 'severe hypoglycemia rate', 'CV risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",9340.0,0.154628,"Liraglutide reduced HbA1c and weight vs placebo in all three subgroups (P < 0.001), and severe hypoglycemia rate in the basal-only insulin subgroup.","[{'ForeName': 'Cees J', 'Initials': 'CJ', 'LastName': 'Tack', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Praxis für Prävention und Therapie, Kardio Metabolisches Institut, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Desouza', 'Affiliation': 'Veterans Affairs Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, UK.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, London, UK.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Helen Vanya B K', 'Initials': 'HVBK', 'LastName': 'Stegmann', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Bosch-Traberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Startseva', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13826']
386,31378952,Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).,"AIMS


While several generic preparations of levodopa/carbidopa and levodopa/benserazide (LBD) are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug.
METHODS


An experimental, 2-centre, randomized, double-blind, 2-sequence, noninferiority cross-over study was designed to evaluate both the PK equivalence and clinical equivalence of multiple doses of the generic preparation of LDB, Teva Italia, compared to the originator (Madopar). Forty-three out-patients with a diagnosis of idiopathic Parkinson's disease on LDB, were recruited and randomly assigned to 1 of 2 study sequences: generic-originator or originator-generic. Clinical evaluations were performed at the end of each study period. A PK study with an LDB fixed dose (100 + 25 mg) was performed in a subpopulation of 14 subjects.
RESULTS


Clinical data showed a reduction of 0.49 and 1.54 in the mean UPDRS III scores for the LDB and the originator, respectively. The 95% CIs [-2.21: 0.11] of the mean difference original vs LDB are smaller than the clinically significant difference of 3 UPDRS III points, supporting the conclusion that the treatment with LDB is not inferior to the originator. No statistically significant differences were found with respect to area under the curve to last dose, half-life, maximum concentration, time to maximum concentration and last observed concentration.
CONCLUSION


These findings prove the therapeutic clinical equivalence as well the PK equivalence of the generic LDB and the originator (Madopar).",2019,"No statistically significant differences were found with respect to AUC 0-t  ,t ½  , C max,  T max  , and C last  .
","['sub-population of 14 subjects', ""Forty-three out-patients with a diagnosis of idiopathic Parkinson's disease (PD) on LDB""]","['Levodopa/carbidopa and Levodopa/benserazide', 'generic-originator or originator-generic', 'Levodopa benserazide (LDB), Teva Italia, compared to the ""originator"" (Madopar®']","['mean UPDRS III scores', 'AUC 0-t  ,t ½  , C max,  T max  , and C last  ']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0005014', 'cui_str': 'Benserazide'}, {'cui': 'C0065502', 'cui_str': 'modopar'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",43.0,0.0506038,"No statistically significant differences were found with respect to AUC 0-t  ,t ½  , C max,  T max  , and C last  .
","[{'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Torti', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Jhessica', 'Initials': 'J', 'LastName': 'Alessandroni', 'Affiliation': 'BioBIM - Multidisciplinary Interistitutional BioBank San Raffaele Pisana -Research Center, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bravi', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Casali', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Grassini', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fossati', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Ialongo', 'Affiliation': 'Department of Physiology and Pharmacology ""Vittorio Erspamer"", Sapienza University of Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Onofrj', 'Affiliation': 'Neurology Department, Università ""G. D\'Annunzio"" di Chieti, Italy.'}, {'ForeName': 'Fabiana Giada', 'Initials': 'FG', 'LastName': 'Radicati', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vacca', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bonassi', 'Affiliation': 'IRCCS San Raffaele Pisana, Clinical and Molecular Epidemiology Unit, Italy (Statistical Analysis) And Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}]",British journal of clinical pharmacology,['10.1111/bcp.14086']
387,31385425,IDegLira improves patient-reported outcomes while using a simple regimen with fewer injections and dose adjustments compared with basal-bolus therapy.,"AIMS


Basal-bolus therapy is associated with greater treatment burden and lower adherence compared with more simplified regimens. This post hoc analysis studied the difference between insulin degludec/liraglutide (IDegLira) and basal-bolus therapy on number of injections, dose adjustments and patient outcomes in the DUAL VII trial.
MATERIALS AND METHODS


DUAL VII was a 26-week, open-label trial in which patients with uncontrolled type 2 diabetes who were using metformin and insulin glargine 100 units/mL (20-50 U) were randomized 1:1 to IDegLira (N = 252) or basal-bolus (insulin glargine U100 + insulin aspart ≤4 times/day) (N = 254). This post hoc analysis reports the observed mean number of injections and cumulative dose adjustments during 26 weeks of treatment. Patient-reported outcomes (Treatment-Related Impact Measure - Diabetes [TRIM-D] and Short Form-36 Health Survey version 2 [SF-36v2]) were collected at scheduled visits and change from baseline scores calculated.
RESULTS


The clinical benefits (non-inferior HbA1c reductions, weight benefit, less hypoglycaemia) of IDegLira vs basal-bolus therapy were achieved with fewer cumulative dose adjustments (16.6 vs 217.2, respectively) and fewer injections (1 vs ≥3 per day, respectively). Patients treated with IDegLira experienced significant improvements across all TRIM-D domains compared with those undergoing basal-bolus therapy. The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
CONCLUSIONS


These findings, combined with the DUAL VII results, suggest that IDegLira, through a more simplified regimen versus basal-bolus therapy, may help improve patient adherence and improve patient outcomes related to diabetes management, treatment burden and mental health, which in turn may assist in the timely achievement of glycaemic control in clinical practice.",2019,"The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
","['patients with uncontrolled type 2 diabetes who were using', '100\u2009units/mL (20-50\u2009U']","['IDegLira (N = 252) or basal-bolus (insulin glargine U100\u2009+\u2009insulin aspart ≤4 times/day', 'metformin and insulin glargine']","['weight benefit, less hypoglycaemia', 'Patient-reported outcomes (Treatment-Related Impact Measure - Diabetes [TRIM-D] and Short Form-36 Health Survey', 'TRIM-D domains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439511', 'cui_str': 'times/day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.087714,"The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation, Bend, Oregon.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'PrimeCare Medical Group, Houston, Texas.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Grøn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Jódar', 'Affiliation': 'University Hospital Quiron Salud, Madrid, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mattis F', 'Initials': 'MF', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, Illinois.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tentolouris', 'Affiliation': 'Laiko General Hospital, Medical School, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Centre, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'Internal Medicine, NorthShore University HealthSystem, Skokie, Illinois.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13851']
388,32302757,Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials.,"OBJECTIVE


Family navigation (FN), a care management strategy, helps families overcome systems and person-level barriers to care. We previously demonstrated FN's feasibility, acceptability, and potential efficacy for increasing access and reducing time to autism-related diagnostic services among low-income, minority children. In this paper, we describe modifications to FN in response to concerns raised in our first pilot randomized controlled trial (RCT), and then assess these modifications in a second pilot RCT.
METHODS


An advisory group recommended modifications to recruitment procedures and study conditions. Forty parent-child dyad participants with autism-related concerns were randomized to receive modified usual care (UC) or modified FN. We compared whether the first and second pilot RCTs differed in: participant enrollment, satisfaction with clinical care, and timely completion of the diagnostic assessment.
RESULTS


Recruitment improved under the modified protocol with significantly fewer potentially eligible families refusing (19.5% vs 4.8%, P < .05) or being excluded from study enrollment (43.6% vs 0%, P < .01). Comparing the first and second pilot RCTs, regardless of study arm, families in the second pilot were more likely to complete diagnostic assessment (UC: hazard ratio [HR] 3.41, 95% confidence intervals [CI 1.20, 9.68]; FN: HR 2.64, 95% CI [1.31, 5.30]) and report greater satisfaction with clinical care. In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
CONCLUSIONS


Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.",2020,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","['Children with Autism', '40 parent-child dyad participants with autism-related concerns', 'low-income, minority children']","['modified usual care (UC) or modified FN', 'Family Navigation (FN']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],,0.105002,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass; Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass. Electronic address: emfeinbe@bu.edu.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Department of Pediatrics, Boston Medical Center (J Kuhn), Boston, Mass.'}, {'ForeName': 'Jenna Sandler', 'Initials': 'JS', 'LastName': 'Eilenberg', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levinson', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Patts', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass.'}]",Academic pediatrics,['10.1016/j.acap.2020.04.007']
389,31787053,Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management.,"Background Despite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD-related risk factors. New strategies are needed to better activate and engage these patients. Methods and Results We conducted a parallel, 2-arm, randomized controlled trial, CREATE Wellness (Changing Results-Engage and Activate to Enhance Wellness) from February 2015 to September 2017 with 12-month follow-up to September 2018. Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2 years before study enrollment. The control group (n=315) received usual care within an existing CVD population-based disease management program. The intervention group (n=332) received usual care plus a group-based behavioral intervention focused on patient activation and engagement. Study outcomes included patient activation and patient-centered care processes (6 months) and healthcare system engagement, medication adherence, and control of CVD risk factors (12 months). Compared with the control group at follow-up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8,  P =0.01), patient-centered care (adjusted mean difference=0.19,  P =0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7,  P =0.01). Intervention and control arms did not differ on improvement in 1-year CVD risk factor control. Conclusions Further work is needed to more effectively connect increased patient activation and engagement to downstream changes in risk factor control. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02302612.",2019,"Compared with the control group at follow-up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8,  P =0.01), patient-centered care (adjusted mean difference=0.19,  P =0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7,  P =0.01).","['Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2\xa0years before study enrollment', 'February 2015 to September 2017 with 12-month follow-up to September 2018']","['usual care within an existing CVD population-based disease management program', 'usual care plus a group-based behavioral intervention']","['patient activation and patient-centered care processes (6\xa0months) and healthcare system engagement, medication adherence, and control of CVD risk factors', 'healthcare system engagement', 'patient-centered care', 'patient activation', '1-year CVD risk factor control']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0243024', 'cui_str': 'Patient-Centered Care'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.0935381,"Compared with the control group at follow-up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8,  P =0.01), patient-centered care (adjusted mean difference=0.19,  P =0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7,  P =0.01).","[{'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Iturralde', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Uratsu', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}, {'ForeName': 'Pranita', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}, {'ForeName': 'Thekla B', 'Initials': 'TB', 'LastName': 'Ross', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research Kaiser Permanente Northern California Oakland CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014021']
390,31747864,Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke.,"Background Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may protect the brain from ischemic reperfusion injury. Methods and Results We performed a phase IIb blinded dose-escalation sham-controlled trial in patients with hyperacute stroke, randomized 1:1 to receive RIC (four 5-minute cycles) or sham to the nonparetic upper limb, in 3 blocks of increasing dose, starting within 6 hours of ictus. The primary outcome was trial feasibility (recruitment, attrition). Secondary outcomes included adherence, tolerability, safety (serious adverse events), plasma biomarkers at days 1 and 4 (S100-ß protein, matrix metalloproteinase-9, and neuron-specific enolase), and functional outcome. Sixty participants were recruited from 2 centers (3 per month) with no loss to follow-up: time to randomization 4 hours 5 minutes (SD 72 minutes), age 72 years (12), men 60%, blood pressure 154/80 mm Hg (25/12), National Institutes of Health Stroke Scale 8.4 (6.9), and 55% thrombolyzed. RIC was well tolerated with adherence not differing between RIC and sham, falling in both groups on day 3 ( P =0.001, repeated measures ANOVA) because of discharge or transfer. S100ß increased in the sham group (mean rise 111 pg/mL [302],  P =0.041, repeated measures ANCOVA) but not the RIC group. There were no differences in matrix metalloproteinase-9, neuron-specific enolase, number with serious adverse events (RIC 10 versus sham 10,  P =0.81), deaths (2 versus 4,  P =0.36), or modified Rankin Scale score (2 [interquartile range 1-4], 2 [interquartile range, 1-3];  P =0.85). Conclusions RIC in hyperacute stroke is feasible when given twice daily for 2 days and appears safe in a small population with hyperacute stroke. A larger phase III trial is warranted. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02779712.",2019,"There were no differences in matrix metalloproteinase-9, neuron-specific enolase, number with serious adverse events (RIC 10 versus sham 10,  P =0.81), deaths (2 versus 4,  P =0.36), or modified Rankin Scale score (2 [interquartile range 1-4], 2 [interquartile range, 1-3];  P =0.85).","['patients with hyperacute stroke', 'Sixty participants were recruited from 2 centers (3 per month) with no loss to follow-up: time to randomization 4\xa0hours 5\xa0minutes (SD 72\xa0minutes), age 72 years (12), men 60%, blood pressure']","['limb ischemia and reperfusion (remote ischemic conditioning [RIC', 'RIC (four 5-minute cycles) or sham to the nonparetic upper limb', 'Remote Ischemic Conditioning']","['adherence, tolerability, safety (serious adverse events), plasma biomarkers at days 1 and 4 (S100-ß protein, matrix metalloproteinase-9, and neuron-specific enolase), and functional outcome', 'trial feasibility (recruitment, attrition', 'modified Rankin Scale score', 'S100ß', 'matrix metalloproteinase-9, neuron-specific enolase, number with serious adverse events', 'deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C1880904', 'cui_str': 'Nervous System-Specific Enolase'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",60.0,0.459399,"There were no differences in matrix metalloproteinase-9, neuron-specific enolase, number with serious adverse events (RIC 10 versus sham 10,  P =0.81), deaths (2 versus 4,  P =0.36), or modified Rankin Scale score (2 [interquartile range 1-4], 2 [interquartile range, 1-3];  P =0.85).","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine Division of Medical Sciences and GEM School of Medicine University of Nottingham Derby United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hedstrom', 'Affiliation': 'Vascular Medicine Division of Medical Sciences and GEM School of Medicine University of Nottingham Derby United Kingdom.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine Division of Medical Sciences and GEM School of Medicine University of Nottingham Derby United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Woodhouse', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience City Hospital Campus University of Nottingham Nottingham United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience City Hospital Campus University of Nottingham Nottingham United Kingdom.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience City Hospital Campus University of Nottingham Nottingham United Kingdom.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience City Hospital Campus University of Nottingham Nottingham United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013572']
391,31240128,Comparison of abdominal compression devices in persons with abdominal paralysis due to spinal cord injury.,"Study Design


Single subject design with five subjects.
Objectives


The objetive of this study is to compare the effectiveness and usability of alternative commercial abdominal compression garments with participants' usual medical binders.
Setting


Private residences in Pierce and King Counties, WA, USA.
Methods


Participants wore each garment for 5 days followed by a 2-day washout in personal binder. Week 1: Personal binder. Weeks 2 and 3: Randomly ordered test garments (tank, bodysuit). Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR). Participants completed logs twice daily for 5 days per garment regarding ease of use, comfort, respiration, and appearance. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
Results


The use of a personal binder results in significant increases in SBP and FEV 1 . Personal binders support FEV 1  significantly better than test garments. There is no difference in SBP between test garments and personal binders. There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder. Participants reported that neither tank nor bodysuit felt adequately supportive or easy to use.
Conclusions


Abdominal compression improves respiratory function and supports SBP in individuals with chronic SCI. Further research is needed to guide the development of an easy-to-use and physiologically supportive abdominal compression garment.",2019,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","['persons with abdominal paralysis due to spinal cord injury', 'human volunteers', 'five subjects', 'individuals with chronic SCI', 'Setting\n\n\nPrivate residences in Pierce and King Counties, WA, USA.\nMethods']","['abdominal compression devices', 'alternative commercial abdominal compression garments', ' Randomly ordered test garments (tank, bodysuit']","['SBP and FEV 1 ', 'DBP, SaO 2 , or HR', 'SBP', 'respiratory function', 'Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",5.0,0.0276293,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","[{'ForeName': 'Michaela de', 'Initials': 'M', 'LastName': 'Groot', 'Affiliation': '1University of Puget Sound, Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swartz', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hastings', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0176-x']
392,31423685,"Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double-blind, randomized trial.","AIMS


To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with 50 U insulin degludec (degludec) or less in Japanese individuals with type 2 diabetes (T2D).
MATERIALS AND METHODS


In this 26-week, double-blind, multicentre, treat-to-target trial, Japanese individuals with T2D that was uncontrolled with basal or pre-mix insulin (20-50 units) were randomized (1:1) to receive IDegLira or degludec, both with metformin. The maximum dose was 50 dose steps (IDegLira) or 50 units (degludec). The primary endpoint was change from baseline in HbA1c with IDegLira vs degludec after 26 weeks of treatment.
RESULTS


In total, 210 Japanese individuals were randomized to IDegLira or degludec and completion rates were 100% and 93%, respectively. IDegLira was superior to degludec with respect to change from baseline in HbA1c: estimated treatment difference (ETD) (95% confidence interval), -13.98 mmol/Mol (-16.41; -11.55); P < 0.0001. The change in mean HbA1c was from 70.6 by -21.3 mmol/Mol with IDegLira and from 70.1 by -7.1 mmol/Mol with degludec. Mean change in body weight was -0.7 kg with IDegLira and 0.7 kg with degludec: ETD (95% CI) -1.41 kg (-2.26; -0.56); P = 0.0012. Mean daily total insulin dose was significantly lower with IDegLira (37.6 U) as compared to that with degludec (41.2 U) at Week 26. Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatment groups.
CONCLUSIONS


IDegLira provided superior reductions in HbA1c compared with ≤50 U degludec, with weight loss and similar hypoglycaemia rates and no unexpected safety or tolerability issues. These results suggest that this treatment could be an attractive intensification option for Japanese subjects with T2D that was uncontrolled with basal or pre-mixed insulin.",2019,"Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatments.
","['Japanese subjects with T2D uncontrolled with basal or pre-mix insulin (20-50 units', 'Japanese subjects with type 2 diabetes (T2D', '210 Japanese subjects', 'Japanese subjects with type 2 diabetes', 'Japanese subjects with T2D uncontrolled on basal or premixed insulin']","['IDegLira or degludec both with metformin', 'Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira', 'insulin degludec/liraglutide (IDegLira', 'mmol/mol ', '≤50 U insulin degludec (degludec']","['Mean daily total insulin dose', 'weight loss and similar hypoglycaemia rates', 'Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events', 'change from baseline in HbA1c of IDegLira vs degludec', 'Mean change in body weight', 'Mean HbA1c']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",210.0,0.41885,"Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatments.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Division of Diabetes/Endocrinology/Lifestyle-related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan.'}, {'ForeName': 'Mitsuhisa', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Bue Ross', 'Initials': 'BR', 'LastName': 'Agner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Mattis', 'Initials': 'M', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13859']
393,31697242,Electronic Screening for Alcohol Use and Brief Intervention by Email for University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework.,"BACKGROUND


Almost a decade ago, Sweden became the first country to implement a national system enabling student health care centers across all universities to routinely administer (via email) an electronic alcohol screening and brief intervention to their students. The Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1) trial aimed to assess the effect of the student health care centers' routine practices by exploiting the lack of any standard timing for the email invitation and by masking trial participation from students. The original analyses adopted the conventional null hypothesis framework, and the results were consistently in the expected direction. However, since for some tests the P values did not pass the conventional .05 threshold, some of the analyses were necessarily inconclusive.
OBJECTIVE


The outcomes of the AMADEUS-1 trial were derived from the first 3 items of the Alcohol Use Disorders Identification Test (AUDIT-C). The aim of this paper was to reanalyze the two primary outcomes of the AMADEUS-1 trial (AUDIT-C scores and prevalence of risky drinking), using the same models used in the original publication but applying a Bayesian inference framework and interpretation.
METHODS


The same regression models used in the original analysis were employed in this reanalysis (linear and logistic regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest.
RESULTS


Where the null hypothesis tests showed inconclusive results, the Bayesian analysis showed that offering an intervention at baseline was preferable compared to offering nothing. At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking.
CONCLUSIONS


The Bayesian analysis allows for a more consistent perspective of the data collected in the trial, since dichotomization of evidence is not looked for at some arbitrary threshold. Results are presented that represent the data collected in the trial rather than trying to make conclusions about the existence of a population effect. Thus, policy makers can think about the value of keeping the national system without having to navigate the treacherous landscape of statistical significance.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN28328154; http://www.isrctn.com/ISRCTN28328154.",2019,"At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking.
","['for University Students', 'university students']",['Electronic Screening for Alcohol Use and Brief Intervention by Email'],['probability of a lower AUDIT-C score'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0519014,"At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking.
","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",Journal of medical Internet research,['10.2196/14419']
394,31241511,The HIP LADIES: A Pilot Health Improvement Project for HIV Prevention in Black College Women.,"A disproportionate number of new HIV infections in the United States occur in Black women. We pilot-tested feasibility and acceptability of a manualized HIV prevention intervention developed with and for Black college women. We used a prospective, randomized 2-group design, with 3 data collection times. Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments. We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes. There were, however, no significant differences between intervention and control groups when considering motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication. We found preliminary evidence of efficacy for an HIV prevention intervention tailored to Black college women. Researchers should partner with Black college women to develop and implement HIV prevention interventions.",2019,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"['Black women', 'Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments', 'Black College Women', 'Black college women']","['manualized HIV prevention intervention', 'HIV prevention intervention']","['behavioral intentions', 'motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication', 'positive changes in HIV knowledge']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",65.0,0.0308477,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"[{'ForeName': 'Rasheeta', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Adedoyin', 'Initials': 'A', 'LastName': 'Shittu', 'Affiliation': ''}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Lescano', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Morrison-Beedy', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000058']
395,31338868,Liraglutide treatment reduced interleukin-6 in adults with type 1 diabetes but did not improve established autonomic or polyneuropathy.,"AIMS


Type 1 diabetes can be complicated with neuropathy that involves immune-mediated and inflammatory pathways. Glucagon-like peptide-1 receptor agonists such as liraglutide, have shown anti-inflammatory properties, and thus we hypothesized that long-term treatment with liraglutide induced diminished inflammation and thus improved neuronal function.
METHODS


The study was a randomized, double-blinded, placebo-controlled trial of adults with type 1 diabetes and confirmed symmetrical polyneuropathy. They were randomly assigned (1:1) to receive either liraglutide or placebo. Titration was 6 weeks to 1.2-1.8 mg/d, continuing for 26 weeks. The primary endpoint was change in latency of early brain evoked potentials. Secondary endpoints were changes in proinflammatory cytokines, cortical evoked potential, autonomic function and peripheral neurophysiological testing.
RESULTS


Thirty-nine patients completed the study, of whom 19 received liraglutide. In comparison to placebo, liraglutide reduced interleukin-6 (-22.6%; 95% confidence interval [CI]: -38.1, -3.2; P = .025) with concomitant numerical reductions in other proinflammatory cytokines. However neuronal function was unaltered at the central, autonomic or peripheral level. Treatment was associated with -3.38 kg (95% CI: -5.29, -1.48; P < .001] weight loss and a decrease in urine albumin/creatinine ratio (-40.2%; 95% CI: -60.6, -9.5; P = .02).
CONCLUSION


Hitherto, diabetic neuropathy has no cure. Speculations can be raised whether mechanism targeted treatment, e.g. lowering the systemic level of proinflammatory cytokines may lead to prevention or treatment of the neuroinflammatory component in early stages of diabetic neuropathy. If ever successful, this would serve as an example of how fundamental mechanistic principles are translated into clinical practice similar to those applied in the cardiovascular and nephrological clinic.",2019,"In comparison to placebo, liraglutide reduced interleukin-6 (-22.6%; 95% confidence interval [CI]: -38.1, -3.2; P = .025) with concomitant numerical reductions in other proinflammatory cytokines.","['Thirty-nine patients completed the study, of whom 19 received', 'adults with type 1 diabetes and confirmed symmetrical polyneuropathy', 'adults with type 1 diabetes']","['Liraglutide', 'liraglutide or placebo', 'liraglutide', 'placebo', 'placebo, liraglutide']","['urine albumin/creatinine ratio', 'weight loss', 'changes in proinflammatory cytokines, cortical evoked potential, autonomic function and peripheral neurophysiological testing', 'change in latency of early brain evoked potentials', 'neuronal function']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0015214', 'cui_str': 'Evoked Potentials'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",39.0,0.649002,"In comparison to placebo, liraglutide reduced interleukin-6 (-22.6%; 95% confidence interval [CI]: -38.1, -3.2; P = .025) with concomitant numerical reductions in other proinflammatory cytokines.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital & Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian Stevns', 'Initials': 'CS', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Holger Jon', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Juhl', 'Affiliation': 'Department of Neurophysiology, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Adam Donald', 'Initials': 'AD', 'LastName': 'Farmer', 'Affiliation': 'Centre for Neuroscience and Trauma, Wingate Institute of Neurogastroenterology, Blizard Institute, Barts and the London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital & Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Riahi', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital and Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Hans Henrik', 'Initials': 'HH', 'LastName': 'Lervang', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Poul Erik', 'Initials': 'PE', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brock', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}]",British journal of clinical pharmacology,['10.1111/bcp.14063']
396,31342534,Abnormalities of mucosal serotonin metabolism and 5-HT 3  receptor subunit 3C polymorphism in irritable bowel syndrome with diarrhoea predict responsiveness to ondansetron.,"BACKGROUND


Irritable bowel syndrome with diarrhoea (IBS-D) is a common condition, greatly reducing the quality of life with few effective treatment options available.
AIM


To report the beneficial response shown in our trial with the 5-hydroyxtryptamine (5-HT) receptor 3 antagonist, ondansetron in IBS-D METHODS: A randomised, placebo-controlled, cross-over trial of 5 weeks of ondansetron versus placebo in 125 patients meeting modified Rome III criteria for IBS-D as previously described. Patients were compared to 21 healthy controls. 5-HT and 5-HIAA were measured in rectal biopsies. Whole gut transit time was assessed using a radio-opaque marker technique. Whole blood DNA was genotyped for an insertion polymorphism in the promoter region of the serotonin transporter gene SLC6A4, as well as single nucleotide polymorphisms (SNPs) of the tryptophan hydroxylase gene TPH1 and 5-HT 3  receptor genes HTR3A, C and E.
RESULTS


Patients' biopsies showed significantly higher 5-HIAA levels (2.1 (1.2-4.2) pmol/mg protein vs 1.1 (0.4-1.5) in controls, P < .0001). 39 patients used < 4 mg/d (""super-responders"") while 55 required ≥ 4 mg/d. 5-HT concentrations in rectal biopsies were significantly lower in super-responders (21.3 (17.0-31.8) vs 37.7 (21.4-61.4), P = .0357) and the increase in transit time on ondansetron was significantly greater (15.6 (1.8-31) hours vs 3.9 (-5.1-17.9) hours). Stool consistency responders were more likely to carry the CC genotype of the SNP p.N163K rs6766410 of the HTR3C gene (33% vs 14%, P = .0066).
CONCLUSION


IBS-D patients have significant abnormalities in mucosal 5-HT metabolism. Those with the lowest concentration of 5-HT in rectal biopsies showed the greatest responsiveness to ondansetron.",2019,"5-HT concentrations in rectal biopsies were significantly lower in super-responders (21.3 (17.0-31.8) vs 37.7 (21.4-61.4), P = .0357) and the increase in transit time on ondansetron was significantly greater (15.6 (1.8-31) hours vs 3.9 (-5.1-17.9) hours).","['21 healthy controls', 'Irritable bowel syndrome with diarrhoea (IBS-D', '125 patients meeting modified Rome III criteria for IBS-D as previously described']","['5-hydroyxtryptamine (5-HT) receptor 3 antagonist', 'ondansetron', 'ondansetron versus placebo', 'placebo']","['5-HT and 5-HIAA', '5-HIAA levels', 'mucosal 5-HT metabolism', 'Whole gut transit time', 'transit time on ondansetron', '5-HT concentrations in rectal biopsies']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea (disorder)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0020361', 'cui_str': '5-HIAA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0193050', 'cui_str': 'Biopsy of rectum (procedure)'}]",125.0,0.0878148,"5-HT concentrations in rectal biopsies were significantly lower in super-responders (21.3 (17.0-31.8) vs 37.7 (21.4-61.4), P = .0357) and the increase in transit time on ondansetron was significantly greater (15.6 (1.8-31) hours vs 3.9 (-5.1-17.9) hours).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunn', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Garsed', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Gulzar', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lingaya', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Wahl', 'Affiliation': 'Department of Human Molecular Genetics, Institute of Human Genetics, University Hospital Heidelberg and Interdisciplinary Center for Neurosciences (IZN), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Niesler', 'Affiliation': 'Department of Human Molecular Genetics, Institute of Human Genetics, University Hospital Heidelberg and Interdisciplinary Center for Neurosciences (IZN), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': 'Department of Therapeutics and Molecular Medicine, NIHR Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Hall', 'Affiliation': 'Department of Therapeutics and Molecular Medicine, NIHR Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whorwell', 'Affiliation': 'Department of Neurogastroenterology, University of South Manchester Wythenshawe General Hospital, Manchester, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Spiller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15420']
397,31766977,Effects of Crushed Ticagrelor Versus Eptifibatide Bolus Plus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention: A Randomized Clinical Trial.,"Background After a loading dose of ticagrelor, the rate of high on-treatment platelet reactivity remains elevated, which increases periprocedural myocardial infarction and injury. This indicates that faster platelet inhibition with crushed ticagrelor (CTIC) or eptifibatide is needed to reduce high on-treatment platelet reactivity. The efficacy of CTIC versus eptifibatide bolus plus clopidogrel is unknown. Methods and Results A total of 100 P2Y 12  naïve, troponin-negative patients with acute coronary syndrome were randomized to CTIC (180 mg) versus eptifibatide bolus (180 μg/kg×2 intravenous boluses) plus clopidogrel (600 mg) at the time of percutaneous coronary intervention. High on-treatment platelet reactivity was markedly higher with CTIC versus eptifibatide bolus plus clopidogrel (42% versus 0%;  P <0.001) at 30 minutes and persisted up to 2 hours (12% versus 0%;  P =0.01, respectively). Platelet aggregation by adenosine diphosphate dropped faster from baseline with eptifibatide bolus plus clopidogrel versus CTIC (0.5 versus 2 hours, respectively) and was higher with CTIC versus eptifibatide bolus plus clopidogrel at 0.5, 2, and 4 hours after loading dose (53±12% versus 1.3±2%; 35±11% versus 0.34±1.0%; and 23±9% versus 3.5±2%, respectively;  P <0.001). Eptifibatide bolus plus clopidogrel, but not CTIC, significantly inhibited platelet aggregation induced by thrombin-receptor activating peptide. Periprocedural myocardial infarction and injury was higher with CTIC versus eptifibatide bolus plus clopidogrel (48% versus 28%, respectively;  P =0.035). Post-percutaneous coronary intervention hemoglobin levels were not different between groups. Conclusions Eptifibatide bolus plus clopidogrel led to faster and more potent platelet inhibition than CTIC and reduced periprocedural myocardial infarction and injury in troponin-negative acute coronary syndrome patients undergoing percutaneous coronary intervention, with no significant hemoglobin drop after percutaneous coronary intervention. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02925923.",2019,"Platelet aggregation by adenosine diphosphate dropped faster from baseline with eptifibatide bolus plus clopidogrel versus CTIC (0.5 versus 2 hours, respectively) and was higher with CTIC versus eptifibatide bolus plus clopidogrel at 0.5, 2, and 4 hours after loading dose (53±12% versus 1.3±2%; 35±11% versus 0.34±1.0%; and 23±9% versus 3.5±2%, respectively;  P <0.001).","['troponin-negative acute coronary syndrome patients undergoing percutaneous coronary intervention, with no significant hemoglobin drop after percutaneous coronary intervention', '100 P2Y 12  naïve, troponin-negative patients with acute coronary syndrome', 'Troponin-Negative Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention']","['clopidogrel', 'Eptifibatide bolus plus clopidogrel', 'eptifibatide bolus', 'eptifibatide bolus plus clopidogrel', 'crushed ticagrelor (CTIC', 'Crushed Ticagrelor Versus Eptifibatide Bolus Plus Clopidogrel', 'ticagrelor', 'eptifibatide', 'CTIC']","['periprocedural myocardial infarction and injury', 'Platelet aggregation', 'periprocedural myocardial infarction', 'Periprocedural myocardial infarction and injury', 'High on-treatment platelet reactivity']","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]",100.0,0.173167,"Platelet aggregation by adenosine diphosphate dropped faster from baseline with eptifibatide bolus plus clopidogrel versus CTIC (0.5 versus 2 hours, respectively) and was higher with CTIC versus eptifibatide bolus plus clopidogrel at 0.5, 2, and 4 hours after loading dose (53±12% versus 1.3±2%; 35±11% versus 0.34±1.0%; and 23±9% versus 3.5±2%, respectively;  P <0.001).","[{'ForeName': 'Moazez J', 'Initials': 'MJ', 'LastName': 'Marian', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Abu Daya', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Arka', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Al Solaiman', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Sasse', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Fonbah', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Workman', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Brittany E', 'Initials': 'BE', 'LastName': 'Johnson', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Brigitta C', 'Initials': 'BC', 'LastName': 'Brott', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Sumanth D', 'Initials': 'SD', 'LastName': 'Prabhu', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Massoud A', 'Initials': 'MA', 'LastName': 'Leesar', 'Affiliation': 'Division of Cardiology University of Alabama at Birmingham AL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012844']
398,31206358,Association of Elevated Plasma Interleukin-18 Level With Increased Mortality in a Clinical Trial of Statin Treatment for Acute Respiratory Distress Syndrome.,"OBJECTIVE


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


Retrospective analysis of randomized controlled clinical trial.
SETTING


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


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


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


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


Elevated baseline plasma interleukin-18 was associated with higher mortality in sepsis-induced acute respiratory distress syndrome. A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.",2019,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"['Acute Respiratory Distress Syndrome', 'Acutely Injured Lungs from Sepsis trial', 'Subjects with acute kidney injury', 'Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis', 'Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population']","['rosuvastatin or placebo', 'statin therapy']","['hazard of death', '60-day mortality', 'Baseline plasma interleukin-18 level', 'plasma interleukin-18 levels', 'mortality']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",683.0,0.63108,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trtchounian', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Kozikowski', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mogan', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Joo Heon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Nakahira', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M', 'Initials': 'AM', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Baron', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Critical care medicine,['10.1097/CCM.0000000000003816']
399,31332820,"Efficacy, safety and pharmacokinetics of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control.","AIMS


The objectives were to investigate the pharmacokinetics, pharmacodynamics and safety of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control, and then recommend the dosage regimen for Phase 2b/3 studies.
METHODS


Three clinical studies were performed. First, 16 healthy subjects received infusion of ilaprazole 30 mg or esomeprazole 80 mg. Second, 12 healthy subjects received ilaprazole 20 mg followed by 10 mg once daily for 2 days. Finally, 20 patients with duodenal ulcers received ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole 40 mg twice daily for 3 days. Serial blood samples were collected and intragastric pH was recorded.
RESULTS


The mean percentages time of intragastric pH >6 was 63.6 and 51.7% for healthy subjects after receiving ilaprazole 30 mg and esomeprazole 80 mg. Linear pharmacokinetics was observed when the dose was increased to 30 mg but the effect was saturated. Ilaprazole 20 mg followed by 10 mg for 2 days provided higher plasma exposure in healthy subjects than patients, but the effect was comparable. After multiple administrations, ilaprazole provided similar effect to esomeprazole. Ilaprazole infusion was safe and well tolerated without serious adverse events.
CONCLUSIONS


Ilaprazole provided comparable effect of pH control to esomeprazole, with lower dose and fewer times of administration. There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibition. A loading dose of ilaprazole 20 mg followed by 10 mg once daily for 2 days was recommended for Phase 2b/3 studies.",2019,There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibiton.,"['healthy subjects and patients with esomeprazole as positive control', 'healthy subjects and patients with', '16 healthy subjects', 'healthy subjects', '20 patients with duodenal ulcers', '12 healthy subjects']","['Ilaprazole infusion', 'ilaprazole 30 mg or esomeprazole', 'ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole', 'Ilaprazole', 'ilaprazole infusion', 'ilaprazole', 'esomeprazole']","['Linear pharmacokinetics', 'Efficacy, safety and pharmacokinetics', 'plasma exposure', 'ilaprazole', 'pharmacokinetics, pharmacodynamics and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}]","[{'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",16.0,0.0331802,There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibiton.,"[{'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ou', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xianghong', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Haitang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14076']
400,31332929,Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial.,"AIMS


The efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the performance of the flash GM system during daily-life glycaemic challenges such as carbohydrate-rich meals, bolus insulin-induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes.
MATERIALS AND METHODS


This study comprised four randomized trial visits with alternating pre- and post-exercise bolus insulin doses. Throughout the four 14-hour inpatient phases, 19 participants received three carbohydrate-rich meals and performed moderate-intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland-Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II-510(K)).
RESULTS


The overall MARD (IQR) during inpatient phases was 14.3% (6.9%-22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%-46.8%), during euglycaemia (4.0 mmol/L - 9.9 mmol/L) was 16.0% (8.5%-24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%-15.7%). Overall Bland-Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (-1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%-39.8%), during hypoglycaemia was 45.1% (35.2%-51.1%), during euglycaemia was 30.7% (18.7%-39.2%) and during hyperglycaemia was 16.3% (10.0%-22.8%).
CONCLUSION


Flash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.",2019,Overall Bland-Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (-1.67 to 4.19 mmol/L).,['individuals with type 1 diabetes'],"['flash glucose monitoring (flash GM', 'Freestyle Libre flash glucose monitoring (flash GM) system', 'carbohydrate-rich meals and performed moderate-intensity exercise']","['Flash GM accuracy', 'Venous blood glucose and capillary blood glucose', 'overall MARD during acute exercise', 'Flash GM interstitial glucose readings', 'overall MARD (IQR', 'hypoglycaemia', 'hyperglycaemia']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",19.0,0.0752566,Overall Bland-Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (-1.67 to 4.19 mmol/L).,"[{'ForeName': 'Othmar', 'Initials': 'O', 'LastName': 'Moser', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Max L', 'Initials': 'ML', 'LastName': 'Eckstein', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Deere', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pitt', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bracken', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13835']
401,31752638,"Severe Hypouricemia Impairs Endothelium-Dependent Vasodilatation and Reduces Blood Pressure in Healthy Young Men: A Randomized, Placebo-Controlled, and Crossover Study.","Background Uric acid (UA) is a plasmatic antioxidant that has possible effects on blood pressure. The effects of UA on endothelial function are unclear. We hypothesize that endothelial function is not impaired unless significant UA depletion is achieved through selective xanthine oxidase inhibition with febuxostat and recombinant uricase (rasburicase). Methods and Results Microvascular hyperemia, induced by iontophoresis of acetylcholine and sodium nitroprusside, and heating-induced local hyperemia after iontophoresis of saline and a specific nitric oxide synthase inhibitor were assessed by laser Doppler imaging. Blood pressure and renin-angiotensin system markers were measured, and arterial stiffness was assessed. CRP (C-reactive protein), allantoin, chlorotyrosine/tyrosine ratio, homocitrulline/lysine ratio, myeloperoxidase activity, malondialdehyde, and interleukin-8 were used to characterize inflammation and oxidative stress. Seventeen young healthy men were enrolled in a randomized, double-blind, placebo-controlled, 3-way crossover study. The 3 compared conditions were placebo, febuxostat alone, and febuxostat together with rasburicase. The allantoin (μmol/L)/UA (μmol/L) ratio differed between sessions ( P <0.0001). During the febuxostat-rasburicase session, heating-induced hyperemia became altered in the presence of nitric oxide synthase inhibition; and systolic blood pressure, angiotensin II, and myeloperoxidase activity decreased ( P ≤0.03 versus febuxostat). The aldosterone concentration decreased in the febuxostat-rasburicase group ( P =0.01). Malondialdehyde increased when UA concentration decreased (both  P <0.01 for febuxostat and febuxostat-rasburicase versus placebo). Other parameters remained unchanged. Conclusions A large and short-term decrease in UA in humans alters heat-induced endothelium-dependent microvascular vasodilation, slightly reduces systolic blood pressure through renin-angiotensin system activity reduction, and markedly reduces myeloperoxidase activity when compared with moderate UA reduction. A moderate or severe hypouricemia leads to an increase in lipid peroxidation through loss of antioxidant capacity of plasma. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03395977.",2019,Malondialdehyde increased when UA concentration decreased (both  P <0.01 for febuxostat and febuxostat-rasburicase versus placebo).,"['Seventeen young healthy men', 'Healthy Young Men']","['Placebo', 'placebo, febuxostat alone, and febuxostat', 'placebo', 'UA', ' Uric acid (UA', 'acetylcholine and sodium nitroprusside']","['UA concentration', 'blood pressure', 'aldosterone concentration', 'Blood pressure and renin-angiotensin system markers', 'lipid peroxidation', 'CRP (C-reactive protein), allantoin, chlorotyrosine/tyrosine ratio, homocitrulline/lysine ratio, myeloperoxidase activity, malondialdehyde, and interleukin-8', 'systolic blood pressure, angiotensin II, and myeloperoxidase activity', 'Blood Pressure', 'systolic blood pressure through renin-angiotensin system activity reduction', 'myeloperoxidase activity']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0035096'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0062931', 'cui_str': 'ureidocaproic acid'}, {'cui': 'C0024337', 'cui_str': 'L-lysine'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",17.0,0.257962,Malondialdehyde increased when UA concentration decreased (both  P <0.01 for febuxostat and febuxostat-rasburicase versus placebo).,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'De Becker', 'Affiliation': 'Department of Cardiology Erasme Hospital Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Coremans', 'Affiliation': 'Department A: Research in Drug Development (RD3)-Pharmacognosy, Bioanalysis and Drug Discovery and Analytical Platform of the Faculty of Pharmacy Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chaumont', 'Affiliation': 'Department of Cardiology Erasme Hospital Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Delporte', 'Affiliation': 'Department A: Research in Drug Development (RD3)-Pharmacognosy, Bioanalysis and Drug Discovery and Analytical Platform of the Faculty of Pharmacy Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Antwerpen', 'Affiliation': 'Department A: Research in Drug Development (RD3)-Pharmacognosy, Bioanalysis and Drug Discovery and Analytical Platform of the Faculty of Pharmacy Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Franck', 'Affiliation': 'Centre of Oxygen, Research and Development Institute of Chemistry B 6a University of Liège-Sart Tilman Liège Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Rousseau', 'Affiliation': 'Laboratory of Experimental Medicine (ULB 222) Medicine Faculty Université Libre de Bruxelles Centre Hospitalier Universitaire de Charleroi, Hopital Vesale Montigny-le-Tilleul Belgium.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Zouaoui Boudjeltia', 'Affiliation': 'Laboratory of Experimental Medicine (ULB 222) Medicine Faculty Université Libre de Bruxelles Centre Hospitalier Universitaire de Charleroi, Hopital Vesale Montigny-le-Tilleul Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cullus', 'Affiliation': 'Biostatistics Department Medicine Faculty Université Libre de Bruxelles Brussels Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'van de Borne', 'Affiliation': 'Department of Cardiology Erasme Hospital Université Libre de Bruxelles Brussels Belgium.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013130']
402,31752643,Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies.,"Background The PROTECT-AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials demonstrated noninferiority of left atrial appendage closure (LAAC) to warfarin for the composite end point of stroke, systemic embolism, or cardiovascular death. This study aims to quantify the net clinical benefit (NCB) of LAAC versus warfarin, accounting for differences in clinical impact of different event types. Methods and Results We performed a post hoc analysis of the PROTECT-AF and PREVAIL trials, which randomized atrial fibrillation patients to LAAC or warfarin in a 2:1 fashion. The trials enrolled patients in the United States and Europe between 2005 and 2012 with paroxysmal, persistent, or permanent atrial fibrillation and CHADS 2  risk scores ≥1. Relative to an index weight for death (1.0), events were assigned weights based on their disabling effect: (1) stroke event weights were based on modified Rankin scores in the base case analyses, and (2) major bleed (0.05) and pericardial effusion (0.05). NCB was calculated as the sum of weight-adjusted events per 100 patient-years. Among 1114 randomized subjects, the NCB of LAAC was 1.42% per year (95% CI 0.01-2.82,  P =0.04) and a relative risk of 0.74 (95% CI 0.56-1.00). NCB point estimates favored warfarin early in follow-up, but trended in favor of LAAC after 1 to 2 years. The benefit of LAAC was preserved across subgroups, with particular benefit observed in the subgroup of prior stroke and without diabetes mellitus. Conclusions This analysis demonstrates long-term NCB of LAAC with Watchman over warfarin therapy, as the upfront risk of periprocedural events is counterbalanced over time by reduced bleeding events and mortality. Clinical Trial Registration UR: http://www.clinicaltrials.gov. Unique identifiers: NCT01182441 and NCT00129545.",2019,"The benefit of LAAC was preserved across subgroups, with particular benefit observed in the subgroup of prior stroke and without diabetes mellitus.","['trials enrolled patients in the United States and Europe between 2005 and 2012 with paroxysmal, persistent, or permanent atrial fibrillation and CHADS 2  risk scores ≥1', 'Patients With Atrial Fibrillation']","['Watchman LAA Closure Device', 'LAAC versus warfarin', 'Warfarin', 'LAAC or warfarin', 'Left Atrial Appendage Closure', 'LAAC']","['NCB of LAAC', 'NCB', 'stroke, systemic embolism, or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation (disorder)'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0335390', 'cui_str': 'Watchman (occupation)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1114.0,0.191151,"The benefit of LAAC was preserved across subgroups, with particular benefit observed in the subgroup of prior stroke and without diabetes mellitus.","[{'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Brouwer', 'Affiliation': 'Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Whang', 'Affiliation': 'Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kuroki', 'Affiliation': 'Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013525']
403,32113924,"Ambulatory Oxygen in Fibrotic Interstitial Lung Disease: A Pilot, Randomized, Triple-Blinded, Sham-Controlled Trial.","BACKGROUND


Despite a lack of evidence, ambulatory oxygen therapy is frequently prescribed for patients with interstitial lung disease (ILD) and exertional desaturation. Patients often prefer portable oxygen concentrators to oxygen cylinders. This study aimed to examine the feasibility of conducting a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD.
RESEARCH QUESTION


Is it feasible to conduct a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD?
STUDY DESIGN AND METHODS


In this randomized, triple-blinded, sham-controlled trial, 30 participants with ILD and isolated exertional desaturation to < 90% on 6-minute walk tests were randomized to 12-week ambulatory oxygen or air delivered via portable concentrators, with assessments performed at baseline and weeks 4, 12, and 18. Primary outcomes were trial feasibility and the change in 6-minute walk distance (6MWD) on room air at week 12.
RESULTS


Study recruitment was completed within 18 months, with six withdrawals. Participant blinding was successful, with the Bang's Blinding Index being 0 (95% CI, -0.40 to 0.40) for the oxygen group and 0 (95% CI, -0.42 to 0.42) for the sham group. No significant difference in 6MWD was seen between groups at week 12 (mean difference of -34 m [95% CI, -105 to 36], P = .34). For secondary outcomes, compared with the sham group, the oxygen group had a significantly higher Leicester Cough Questionnaire psychological domain score, indicating better cough-related quality of life (mean difference of 0.9 [95% CI, 0.2 to 1.6], P = .01), but a shorter duration of moderate-to-vigorous activities (mean difference of -135 [95% CI, -267 to -3], P = .04) at week 12.
INTERPRETATION


Based on the results of this pilot study, a definitive randomized controlled trial with a longer intervention duration is warranted to clarify therapeutic impacts of ambulatory oxygen in patients with ILD.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000054314; URL: www.anzctr.org.au/.",2020,"There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34).","['fibrotic ILD', 'patients with ILD', '30 participants with ILD and isolated exertional desaturation to <90% on 6-minute walk tests', 'patients with interstitial lung disease (ILD) and exertional desaturation']","['ambulatory oxygen therapy', 'ambulatory oxygen or air delivered via portable concentrators', 'portable oxygen concentrators to oxygen cylinders', 'ambulatory oxygen delivered via portable concentrators']","['Leicester Cough Questionnaire psychological domain score', 'shorter duration of moderate-to-vigorous activities', 'cough-related quality of life', 'trial feasibility and the change in 6-minute walk distance (6MWD) on room air at Week 12', '6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1618343', 'cui_str': 'Portable oxygen concentrator (physical object)'}, {'cui': 'C0182124', 'cui_str': 'Oxygen cylinder (physical object)'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",30.0,0.571943,"There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34).","[{'ForeName': 'Yet H', 'Initials': 'YH', 'LastName': 'Khor', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; School of Medicine, University of Melbourne, Melbourne, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia. Electronic address: yethong.khor@austin.org.au.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Physiotherapy, Alfred Health and Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicole S L', 'Initials': 'NSL', 'LastName': 'Goh', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Miller', 'Affiliation': 'Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Vlahos', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bozinovski', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Aroub', 'Initials': 'A', 'LastName': 'Lahham', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Glaspole', 'Affiliation': 'Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; School of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}]",Chest,['10.1016/j.chest.2020.01.049']
404,31774955,Randomized Trial of Three Anticonvulsant Medications for Status Epilepticus.,"BACKGROUND


The choice of drugs for patients with status epilepticus that is refractory to treatment with benzodiazepines has not been thoroughly studied.
METHODS


In a randomized, blinded, adaptive trial, we compared the efficacy and safety of three intravenous anticonvulsive agents - levetiracetam, fosphenytoin, and valproate - in children and adults with convulsive status epilepticus that was unresponsive to treatment with benzodiazepines. The primary outcome was absence of clinically evident seizures and improvement in the level of consciousness by 60 minutes after the start of drug infusion, without additional anticonvulsant medication. The posterior probabilities that each drug was the most or least effective were calculated. Safety outcomes included life-threatening hypotension or cardiac arrhythmia, endotracheal intubation, seizure recurrence, and death.
RESULTS


A total of 384 patients were enrolled and randomly assigned to receive levetiracetam (145 patients), fosphenytoin (118), or valproate (121). Reenrollment of patients with a second episode of status epilepticus accounted for 16 additional instances of randomization. In accordance with a prespecified stopping rule for futility of finding one drug to be superior or inferior, a planned interim analysis led to the trial being stopped. Of the enrolled patients, 10% were determined to have had psychogenic seizures. The primary outcome of cessation of status epilepticus and improvement in the level of consciousness at 60 minutes occurred in 68 patients assigned to levetiracetam (47%; 95% credible interval, 39 to 55), 53 patients assigned to fosphenytoin (45%; 95% credible interval, 36 to 54), and 56 patients assigned to valproate (46%; 95% credible interval, 38 to 55). The posterior probability that each drug was the most effective was 0.41, 0.24, and 0.35, respectively. Numerically more episodes of hypotension and intubation occurred in the fosphenytoin group and more deaths occurred in the levetiracetam group than in the other groups, but these differences were not significant.
CONCLUSIONS


In the context of benzodiazepine-refractory convulsive status epilepticus, the anticonvulsant drugs levetiracetam, fosphenytoin, and valproate each led to seizure cessation and improved alertness by 60 minutes in approximately half the patients, and the three drugs were associated with similar incidences of adverse events. (Funded by the National Institute of Neurological Disorders and Stroke; ESETT ClinicalTrials.gov number, NCT01960075.).",2019,"The primary outcome of cessation of status epilepticus and improvement in the level of consciousness at 60 minutes occurred in 68 patients assigned to levetiracetam (47%; 95% credible interval, 39 to 55), 53 patients assigned to fosphenytoin (45%; 95% credible interval, 36 to 54), and 56 patients assigned to valproate (46%; 95% credible interval, 38 to 55).","['patients with status epilepticus', '384 patients', 'Status Epilepticus', 'children and adults with convulsive status epilepticus']","['anticonvulsive agents - levetiracetam, fosphenytoin, and valproate ', 'benzodiazepines', 'fosphenytoin (118), or valproate', 'levetiracetam', 'Anticonvulsant Medications', 'valproate', 'benzodiazepine']","['deaths', 'adverse events', 'episodes of hypotension and intubation', 'efficacy and safety', 'seizure cessation and improved alertness', 'psychogenic seizures', 'cessation of status epilepticus and improvement in the level of consciousness', 'absence of clinically evident seizures and improvement in the level of consciousness', 'life-threatening hypotension or cardiac arrhythmia, endotracheal intubation, seizure recurrence, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311335', 'cui_str': 'Grand Mal Status Epilepticus'}]","[{'cui': 'C0003286', 'cui_str': 'Anticonvulsive Agents'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1142430', 'cui_str': 'Psychogenic seizure'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",384.0,0.42706,"The primary outcome of cessation of status epilepticus and improvement in the level of consciousness at 60 minutes occurred in 68 patients assigned to levetiracetam (47%; 95% credible interval, 39 to 55), 53 patients assigned to fosphenytoin (45%; 95% credible interval, 36 to 54), and 56 patients assigned to valproate (46%; 95% credible interval, 38 to 55).","[{'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cloyd', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Meinzer', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cock', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Fountain', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': ""From the Department of Neurology, University of Virginia, Charlottesville (J.K., N.F.); the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E., C.M.); the Division of Emergency Medicine, Children's National Medical Center, Washington, DC (J.M.C.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B., R.S.); the College of Pharmacy, Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis (J.C.); the Department of Neurology, University of California, San Francisco, San Francisco (D.L.); the Departments of Neurology and Pediatrics, Albert Einstein College of Medicine, Montefiore Medical Center, New York (S.S.); the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (R.C.); St. George's University of London and St. George's University Hospitals NHS Foundation Trust, London (H.C.); and ConfluenceStat (J.T.C.) and the University of Central Florida College of Medicine (J.T.C.) - both in Orlando.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1905795']
405,31264767,Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial.,"AIMS


To assess the dose-related effects of sotagliflozin, a novel dual inhibitor of sodium-glucose co-transporters-1 and -2, in type 1 diabetes (T1D).
MATERIALS AND METHODS


In this 12-week, multicentre, randomized, double-blind, placebo-controlled dose-ranging trial, adults with T1D were randomized to once-daily placebo (n = 36) or sotagliflozin 75 mg (n = 35), 200 mg (n = 35) or 400 mg (n = 35). Insulin was maintained at baseline doses. The primary endpoint was least squares mean (LSM) change in glycated haemoglobin (HbA1c) from baseline. Other endpoints included proportion of participants with ≥0.5% HbA1c reduction and assessments of 2-hour postprandial glucose (PPG), weight, and urinary glucose excretion (UGE).
RESULTS


From a mean baseline of 8.0% ± 0.8% (full study population), placebo-adjusted LSM HbA1c decreased by 0.3% (P = .07), 0.5% (P < .001) and 0.4% (P = .006) with sotagliflozin 75 mg, 200 mg and 400 mg, respectively, at week 12. In the placebo and sotagliflozin 75 mg, 200 mg and 400 mg groups, 33.3%, 37.1%, 80.0% and 65.7% of participants achieved an HbA1c reduction ≥0.5%. Placebo-adjusted PPG decreased by 22.2 mg/dL (P = .28), 28.7 mg/dL (P = .16) and 50.2 mg/dL (P = .013), UGE increased by 41.8 g/d (P = .006), 57.7 g/d (P < .001) and 70.5 g/d (P < .001), and weight decreased by 1.3 kg (P = .038), 2.4 kg (P < .001) and 2.6 kg (P < .001) with sotagliflozin 75 mg, 200 mg and 400 mg, respectively. One case of severe hypoglycaemia occurred in each sotagliflozin group and one case of diabetic ketoacidosis (DKA) occurred with sotagliflozin 400 mg.
CONCLUSIONS


Combined with stable insulin doses, sotagliflozin 200 mg and 400 mg improved glycaemic control and weight in adults with T1D. Sotagliflozin 400 mg reduced PPG levels. UGE increased with all sotagliflozin doses. Rates of severe hypoglycaemia and DKA were low (NCT02459899).",2019,"Placebo-adjusted PPG decreased by 22.2 (P=0.28), 28.7 (P=0.16), and 50.2 mg/dL (P=0.013); UGE increased by 41.8 (P=0.006), 57.7 (P<0.001), and 70.5 g/day (P<0.001); and weight decreased 1.3 (P=0.038), 2.4 (P<0.001), and 2.6 kg (P<0.001) with sotagliflozin 75, 200, and 400 mg, respectively.","['adults with T1D', 'type 1 diabetes (T1D']","['placebo', 'Placebo', 'placebo and sotagliflozin', 'sotagliflozin', 'Sotagliflozin']","['UGE', 'diabetic ketoacidosis (DKA', 'PPG', 'glycemic control and weight', 'least squares mean (LSM) A1C change', 'Rates of severe hypoglycemia and DKA', 'proportion with ≥0.5% A1C reduction and assessments of 2-hour postprandial glucose (PPG), weight, and urinary glucose excretion (UGE', 'severe hypoglycemia', 'placebo-adjusted LSM A1C', 'weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3896939'}]","[{'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",,0.469834,"Placebo-adjusted PPG decreased by 22.2 (P=0.28), 28.7 (P=0.16), and 50.2 mg/dL (P=0.013); UGE increased by 41.8 (P=0.006), 57.7 (P<0.001), and 70.5 g/day (P<0.001); and weight decreased 1.3 (P=0.038), 2.4 (P<0.001), and 2.6 kg (P<0.001) with sotagliflozin 75, 200, and 400 mg, respectively.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Diabetes and Endocrine Associates, Omaha, Nebraska.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Wason', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'John Muir Physician Network, Concord, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Department of Diabetes, Endocrinology, and Clinical Research, Children's and Youth Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gesty-Palmer', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Kushner', 'Affiliation': 'McNair Interests & McNair Medical Institute, Houston, Texas.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mikell', 'Affiliation': 'Chief Physician Executive, Hospital Sisters Health System, Springfield, Illinois.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Neill"", 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Strumph', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13825']
406,31364266,Effect of once-weekly dulaglutide versus insulin glargine in people with type 2 diabetes and different baseline glycaemic patterns: A post hoc analysis of the AWARD-2 clinical trial.,"The long-acting glucagon-like peptide-1 receptor agonist dulaglutide acts by stimulating insulin secretion and reducing glucagon levels in a glucose-dependent manner both in the fasting and postprandial states, resulting in reductions of both fasting glucose (FG) and postprandial glucose (PPG). In contrast, the main mechanism of action of basal insulin is to reduce elevated FG by inhibiting hepatic glucose production. The aim of the present post hoc analysis of the phase 3 AWARD-2 trial was to investigate whether specific baseline glycaemic patterns respond differentially to dulaglutide compared to insulin glargine (glargine). We categorized participants into four subgroups based on prespecified glucose thresholds and their baseline FG and daily 2-hour mean PPG: low FG/low PPG; low FG/high PPG; high FG/low PPG; and high FG/high PPG. Changes in glycaemic measures in response to treatment with dulaglutide or glargine were evaluated in each subgroup. At 52 weeks, significant reductions from baseline in glycated haemoglobin (HbA1c) were observed in all subgroups with dulaglutide 1.5 mg and with glargine (all P < .05), except in patients with low FG/low PPG who received glargine. Greater HbA1c reductions were observed with dulaglutide 1.5 mg compared to glargine in all subgroups (all P ≤ .05), except in the low FG/high PPG subgroup.",2019,"At 52 weeks, significant reductions from baseline in glycated haemoglobin (HbA1c) were observed in all subgroups with dulaglutide 1.5 mg and with glargine (all P < .05), except in patients with low FG/low PPG who received glargine.","['people with type 2 diabetes and different baseline glycaemic patterns', 'categorized participants into four subgroups based on prespecified glucose thresholds and their baseline FG and daily 2-hour mean PPG: low FG/low PPG; low FG/high PPG; high FG/low PPG; and high FG/high PPG']","['insulin glargine (glargine', 'dulaglutide or glargine', 'glargine', 'dulaglutide versus insulin glargine']","['glucagon levels', 'glycated haemoglobin (HbA1c', 'fasting glucose (FG) and postprandial glucose (PPG', 'glycaemic measures', 'Greater HbA1c reductions']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}]","[{'cui': 'C0337437', 'cui_str': 'Glucagon test (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0518851,"At 52 weeks, significant reductions from baseline in glycated haemoglobin (HbA1c) were observed in all subgroups with dulaglutide 1.5 mg and with glargine (all P < .05), except in patients with low FG/low PPG who received glargine.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Milicevic', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13844']
407,31364269,"Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes.","Dapagliflozin is associated with greater reductions in HbA1c and weight than saxagliptin in management of type 2 diabetes mellitus (T2DM). The present post hoc analyses compared the durability of these effects over short- and long-term follow-up in patients with T2DM who were inadequately controlled with metformin (≥1500 mg/day) and who were receiving either dapagliflozin (10 mg/day) or saxagliptin (5 mg/day). Failure of glycaemiccontrol was assessed using the slope of the change in HbA1c from baseline-over-time regression line (coefficient of failure [CoF]). CoF was compared directly (dapagliflozin vs saxagliptin) over the short term (NCT01606007, 24 weeks) and indirectly (placebo-adjusted) over the long term (NCT00528879 and NCT00121667, 102 weeks). A low CoF value indicated greater durability. CoF was lower for dapagliflozin versus saxagliptin over 18-24 weeks (-1.38%/year; 95% CI, -2.41 to -0.35; P = .009) and 20-102 weeks (-0.37%/year; 95% CI, -0.73 to -0.02; P = .04). Fewer dapagliflozin-treated patients versus saxagliptin-treated patients required rescue medication or discontinued the study because of failure to achieve glycaemic control at 24 weeks (3.4% vs 9.4%; P = .0191). In patients with T2DM who were inadequately controlled with metformin, dapagliflozin was associated with greater durability of glycaemic control than saxagliptin over 18-24 and 20-102 weeks.",2019,Dapagliflozin is associated with greater reductions in HbA1c and weight than saxagliptin in management of type 2 diabetes mellitus (T2DM).,"['patients with inadequately controlled type 2 diabetes', 'patients with T2DM who were inadequately controlled with']","['saxagliptin', 'dapagliflozin versus saxagliptin', 'directly (dapagliflozin vs saxagliptin', 'dapagliflozin', 'metformin, dapagliflozin', 'metformin', 'Dapagliflozin']","['HbA1c and weight', 'durability of glycaemic control', 'durability', 'Failure of glycaemiccontrol', 'CoF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.112224,Dapagliflozin is associated with greater reductions in HbA1c and weight than saxagliptin in management of type 2 diabetes mellitus (T2DM).,"[{'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Bailey', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'AstraZeneca, R&D Bio Pharmaceuticals, Late CVRM, Gaithersburg, Maryland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reyner', 'Affiliation': 'AstraZeneca, R&D Bio Pharmaceuticals, Late CVRM, Gaithersburg, Maryland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Saraiva', 'Affiliation': 'AstraZeneca, R&D Bio Pharmaceuticals, Late CVRM, Gaithersburg, Maryland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13841']
408,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
409,31264757,Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study.,"AIM


To evaluate the safety of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), and its effects on body weight management in adults without diabetes.
MATERIALS AND METHODS


In this phase II, randomized, placebo-controlled, double-blind trial, participants with a body mass index (BMI) ≥30 kg/m 2  or ≥27 kg/m 2  with comorbidity were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet. The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
RESULTS


Over 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo (P < 0.0001), with placebo-adjusted reductions ranging between -6.3 kg (6 mg once every 2 wk) and -7.2 kg (6 mg once weekly). Greater proportions of efpeglenatide-treated participants had body weight loss of ≥5% or ≥10% versus placebo (P < 0.01, all comparisons). Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo. Rates of study discontinuations as a result of adverse events ranged from 5% to 19% with efpeglenatide. Gastrointestinal effects were the most common treatment-emergent adverse events.
CONCLUSIONS


Efpeglenatide once weekly and once every 2 wk led to significant body weight reduction and improved glycaemic and lipid variables versus placebo. It was also well tolerated for weight management in adults without diabetes.",2019,"Efpeglenatide led to significant improvements in glycaemic parameters (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) vs placebo.","['adults without diabetes', 'patients with body mass index (BMI) ≥30 kg/m 2  or ≥27 kg/m 2  with co-morbidity']","['placebo', 'efpeglenatide', 'Efpeglenatide QW and Q2W', 'placebo (n = 60) in combination with a hypocaloric diet', 'efpeglenatide (4 mg once weekly [QW', 'glucagon-like peptide-1 receptor agonist (GLP-1 RA']","['body-weight loss', 'body weight reduction and improved glycaemic and lipid parameters', 'Gastrointestinal effects', 'body-weight change', 'body weight', 'glycaemic parameters (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.532643,"Efpeglenatide led to significant improvements in glycaemic parameters (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) vs placebo.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Jahoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'Clinical and Regulatory Development, ProSciento, Chula Vista, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Chula Vista, California.'}, {'ForeName': 'OakPil', 'Initials': 'O', 'LastName': 'Han', 'Affiliation': 'Department of Biometrics, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, Sanofi Canada, Laval, Quebec, Canada.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Sorli', 'Affiliation': 'Medical Affairs, Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Praxis für Prävention und Therapie, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'Endocrinology and Metabolism, Catholic University of Korea, Seoul, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13824']
410,31264764,Risk of clinically relevant hypoglycaemia in patients with type 2 diabetes self-titrating insulin glargine U-100.,"AIMS


We evaluated risk factors for clinically relevant hypoglycaemia (blood glucose <3 mmol/L) in patients with type 2 diabetes during insulin glargine self-titration. Data were from two clinical trials in which patients were able to improve glycaemic control by self-titration of insulin glargine using a simple algorithm.
MATERIALS AND METHODS


We performed post hoc analyses of pooled treatment groups from each of two Phase 3 studies comparing LY2963016 with LANTUS: ELEMENT-2 (double-blind) and ELEMENT-5 (open label). Clinically relevant hypoglycaemia was analysed by category of HbA1c (<7%, 7%-8.5%, >8.5%) at Week 12 (titration period) and at Week 24 (overall study), and by subgroups of age (<65, ≥65 years) and previous insulin use (naïve or not).
RESULTS


In the ELEMENT-2 study (N = 756), there were no overall differences in rate or incidence of hypoglycaemia among HbA1c categories. In the ELEMENT-5 study (N = 493), patients with HbA1c greater than 8.5% had a lower rate and incidence of hypoglycaemia throughout the study compared to those in the lower HbA1c categories. In both studies, patients 65 years of age or older, compared to those less than 65 years, had a higher rate and incidence of hypoglycaemia during the titration phase, had lower baseline HbA1c, and experienced smaller increases in dose, with no differences in HbA1c post baseline. The rate and incidence of hypoglycaemia was similar between naïve patients and patients previously using basal insulin, across all levels of glycaemic control. With the exception of the older subgroup, hypoglycaemia rates were similar during titration and maintenance periods.
CONCLUSION


Our results support broader use of self-titration algorithms for patients with type 2 diabetes.",2019,"In ELEMENT-2 (N=756), there were no overall differences in rate or incidence of hypoglycaemia among HbA1c categories.","['Patients with Type 2 Diabetes Self-titrating Insulin Glargine U-100', 'patients with type 2 diabetes', 'patients with type 2 diabetes during insulin glargine self-titration']",[],"['Risk of Clinically Relevant Hypoglycaemia', 'rate and incidence of hypoglycaemia', 'hypoglycaemia rates', 'Clinically relevant hypoglycaemia', 'rate or incidence of hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.110307,"In ELEMENT-2 (N=756), there were no overall differences in rate or incidence of hypoglycaemia among HbA1c categories.","[{'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Hollander', 'Affiliation': 'Department of Endocrinology, Baylor Endocrine Center, Dallas, Texas.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kiljanski', 'Affiliation': 'Department of Diabetes, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Spaepen', 'Affiliation': 'Department of Statistics, Eli Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Harris', 'Affiliation': 'Department of Diabetes, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13822']
411,32271290,Comparison of Plyometric Training With Two Different Jumping Techniques on Achilles Tendon Properties and Jump Performances.,"Laurent, C, Baudry, S, and Duchateau, J. Comparison of plyometric training with two different jumping techniques on Achilles tendon properties and jump performances. J Strength Cond Res 34(6): 1503-1510, 2020-This study compared the influence of 10 weeks of plyometric training with 2 different jumping techniques on Achilles tendon properties and the height achieved in drop jumps (from 20, 40, and 60 cm) and countermovement jumps (CMJ). Subjects were allocated to 2 training groups (n = 11 in each group) and 1 control group (CON, n = 10). One training group kept the knees extended (KE) during ground contact, whereas the other training group flexed the knees to ∼80-90° (KF). Achilles tendon stiffness was assessed with ultrasonography, and jump performance was derived from force platform recording. Training increased jump height (p < 0.01) in both groups. The increase for the 20-cm drop jump was greater (p < 0.05) for the KE group (11.3%) thanfor the KF group (6.3%), with no statistical difference between groups for the 40- and 60-cm drop jumps. Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups. The increase in CMJ height was greater (p = 0.05) for the KF group (17.5%) than for the KE group (11.8%). Achilles tendon stiffness increased (32%; p < 0.001) for the KE group but not for the KF group (11%; p = 0.28). There was a positive association (p < 0.001) between the changes in tendon stiffness and jump height for 20-cm drop jump in both KE group (r = 0.49) and KF group (r = 0.62). None of these parameters changed in CON group. In conclusion, the extent of increase in jump height (20-cm drop jump and CMJ) and in Achilles tendon stiffness after training differed between the 2 jumping techniques.",2020,"Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups.",[],"['plyometric training with 2 different jumping techniques on Achilles tendon properties and the height achieved in drop jumps (from 20, 40, and 60 cm) and countermovement jumps (CMJ', 'J Strength Cond Res XX(X', 'One training group kept the knees extended (KE) during ground contact, whereas the other training group flexed the knees to ∼80-90° (KF', 'Plyometric Training With Two Different Jumping Techniques']","['Tendon Properties and Jump Performances', 'tendon stiffness and jump height', 'Achilles tendon stiffness', 'jump height', 'CMJ height', 'Achilles tendon properties and jump performances', 'Contact time']",[],"[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0186026,"Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups.","[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Help Center for Sports Performance (CAPS), Free University of Brussels (ULB), Brussels.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Baudry', 'Affiliation': 'Laboratory of Applied Biology and Neurophysiology, Free University of Brussels (ULB), Brussels.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duchateau', 'Affiliation': 'Help Center for Sports Performance (CAPS), Free University of Brussels (ULB), Brussels.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003604']
412,31658442,Evaluating the effectiveness of video cases to improve patient-centeredness in psychiatry: a quasi-experimental study.,"Objectives


To evaluate the effectiveness of including interactive video-based patient cases in preparatory lectures on medical students' patient-centredness and attitudes towards psychiatry.
Methods


This study was designed as a quasi-experimental intervention study. A preparatory lecture on diagnostic interviewing was given to 204 fourth-year medical students before a 4-week psychiatry clerkship. The students were divided into two groups. One group (n=102) received a preparatory lecture including an interactive video case portraying a doctor performing a diagnostic interview with a simulated patient (intervention group). The other group (n=102) received a conventional preparatory lecture using text-based instructional material (control group). We conducted a paired sample t-test to compare the students' confidence in exhibiting patient-centred communication and their attitudes towards psychiatry before receiving the preparatory lecture and after having completed a minimum of three weeks of clerkship training.
Results


A total of 102 students, 51 in each group, completed a questionnaire at both measurement points. In the intervention group, we found a statistically significantly difference for the students' patient-centredness before (M=69.4, SD=10.0) and after (M=73.8, SD=8.6) the intervention t (97) =2.38, p= 0.02, but no changes in attitudes t (98)  =1.07, p=0.28. In the control group, we found no changes in patient-centredness or attitudes.
Conclusions


Video cases in preparatory lectures appear to be better than text-based material at improving students' patient-centredness in psychiatry. However, neither video cases nor text-based material seem to influence the students' attitudes.",2019,"In the intervention group, we found a statistically significantly difference for the students' patient-centredness before (M=69.4, SD=10.0) and after (M=73.8, SD=8.6) the intervention t (97) =","[""medical students' patient-centredness and attitudes towards psychiatry"", ""students' confidence in exhibiting patient-centred communication and their attitudes towards psychiatry before receiving the preparatory lecture and after having completed a minimum of three weeks of clerkship training"", 'A total of 102 students, 51 in each group, completed a questionnaire at both measurement points']","['conventional preparatory lecture using text-based instructional material (control group', 'preparatory lecture including an interactive video case portraying a doctor performing a diagnostic interview with a simulated patient (intervention group', 'interactive video-based patient cases in preparatory lectures']","[""students' patient-centredness"", 'patient-centredness or attitudes']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3875150', 'cui_str': 'Towards'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",204.0,0.0153829,"In the intervention group, we found a statistically significantly difference for the students' patient-centredness before (M=69.4, SD=10.0) and after (M=73.8, SD=8.6) the intervention t (97) =","[{'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Health Sciences Education, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bennedsen', 'Affiliation': 'Centre for Health Sciences Education, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Rungø', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Paltved', 'Affiliation': 'Corporate HR, MidtSim, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Anne Mette', 'Initials': 'AM', 'LastName': 'Morcke', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation at Rigshospitalet, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ringsted', 'Affiliation': 'Centre for Health Sciences Education, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mors', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark.'}]",International journal of medical education,['10.5116/ijme.5d9b.1e88']
413,31995683,Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial.,"BACKGROUND


There are limited data from randomized trials regarding whether volume-based, low-dose computed tomographic (CT) screening can reduce lung-cancer mortality among male former and current smokers.
METHODS


A total of 13,195 men (primary analysis) and 2594 women (subgroup analyses) between the ages of 50 and 74 were randomly assigned to undergo CT screening at T0 (baseline), year 1, year 3, and year 5.5 or no screening. We obtained data on cancer diagnosis and the date and cause of death through linkages with national registries in the Netherlands and Belgium, and a review committee confirmed lung cancer as the cause of death when possible. A minimum follow-up of 10 years until December 31, 2015, was completed for all participants.
RESULTS


Among men, the average adherence to CT screening was 90.0%. On average, 9.2% of the screened participants underwent at least one additional CT scan (initially indeterminate). The overall referral rate for suspicious nodules was 2.1%. At 10 years of follow-up, the incidence of lung cancer was 5.58 cases per 1000 person-years in the screening group and 4.91 cases per 1000 person-years in the control group; lung-cancer mortality was 2.50 deaths per 1000 person-years and 3.30 deaths per 1000 person-years, respectively. The cumulative rate ratio for death from lung cancer at 10 years was 0.76 (95% confidence interval [CI], 0.61 to 0.94; P = 0.01) in the screening group as compared with the control group, similar to the values at years 8 and 9. Among women, the rate ratio was 0.67 (95% CI, 0.38 to 1.14) at 10 years of follow-up, with values of 0.41 to 0.52 in years 7 through 9.
CONCLUSIONS


In this trial involving high-risk persons, lung-cancer mortality was significantly lower among those who underwent volume CT screening than among those who underwent no screening. There were low rates of follow-up procedures for results suggestive of lung cancer. (Funded by the Netherlands Organization of Health Research and Development and others; NELSON Netherlands Trial Register number, NL580.).",2020,"In this trial involving high-risk persons, lung-cancer mortality was significantly lower among those who underwent volume CT screening than among those who underwent no screening.","['13,195 men (primary analysis) and 2594 women (subgroup analyses) between the ages of 50 and 74 were randomly assigned to']","['undergo CT screening', 'low-dose computed tomographic (CT) screening', 'volume CT screening']","['lung-cancer mortality', 'overall referral rate for suspicious nodules', 'incidence of lung cancer', 'cumulative rate ratio for death from lung cancer', 'average adherence to CT screening', 'Lung-Cancer Mortality', 'rate ratio']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",13195.0,0.146316,"In this trial involving high-risk persons, lung-cancer mortality was significantly lower among those who underwent volume CT screening than among those who underwent no screening.","[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'van der Aalst', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Scholten', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Kristiaan', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Jan-Willem J', 'Initials': 'JJ', 'LastName': 'Lammers', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Weenink', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Uraujh', 'Initials': 'U', 'LastName': 'Yousaf-Khan', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Horeweg', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""van 't Westeinde"", 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Prokop', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Willem P', 'Initials': 'WP', 'LastName': 'Mali', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Firdaus A A', 'Initials': 'FAA', 'LastName': 'Mohamed Hoesein', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'van Ooijen', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'den Bakker', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunnissen', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Johny', 'Initials': 'J', 'LastName': 'Verschakelen', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Walter', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ten Haaf', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'From the Departments of Public Health (H.J.K., C.M.A., U.Y.-K., K.H.) and Pulmonology (J.G.J.V.A.), Erasmus MC-University Medical Center Rotterdam, and the Departments of Pulmonology (S.W.) and Pathology (M.A.B.), Maasstad Hospital, Rotterdam, the Departments of Radiology (P.A.J., W.P.M., F.A.A.M.H.) and Pulmonology (J.-W.J.L.), University Medical Center Utrecht, Utrecht, the Departments of Radiology (E.T.S.) and Pulmonology (C.W.), Spaarne Gasthuis, Haarlem, the Department of Radiation Oncology, Leiden University Medical Center, Leiden (N.H.), the Faculty of Medical Sciences (M.A.H., J.E.W., M.O.), the Data Science Center in Health (P.M.A.O.), and the Departments of Radiology (R.V.) and Pulmonology (H.J.M.G), University of Groningen-University Medical Center Groningen, and the Institute for DiagNostic Accuracy (J.E.W., M.O.), Groningen, the Department of Radiology, Radboud University Medical Center, Nijmegen (M.P.), and the Department of Pathology, University Medical Center Amsterdam, Amsterdam (E.T.) - all in the Netherlands; and the Departments of Pulmonology (K.N.) and Radiology (J.V.), KU Leuven, University Hospital, Leuven, Belgium.'}]",The New England journal of medicine,['10.1056/NEJMoa1911793']
414,32291095,"A randomized half-body, double blind, controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis.","BACKGROUND


Higher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis.
OBJECTIVE


To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.
METHODS


A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.
RESULTS


A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
STUDY LIMITATION


Skin hydration was not evaluated.
CONCLUSION


Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.",2020,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
","['patients with stable atopic dermatitis', 'atopic dermatitis', 'mild to moderate atopic dermatitis', 'A total of 6 (16.7%) males and 30 (83.3%) females participated']","['Moisturization', 'pH-modified moisturizer vs. standard moisturizer', 'pH-modified moisturizer and standard moisturizer']","['greater pH, TEWL and SCORAD improvements', 'Reduction in pH', 'pH reductions', 'SCORAD', 'atopic dermatitis', 'Transepidermal water loss (TEWL', 'Skin pH reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}]",,0.11098,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
","[{'ForeName': 'Siew Wen', 'Initials': 'SW', 'LastName': 'Goh', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Adawiyah', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia. Electronic address: adda_jamil@yahoo.com.'}, {'ForeName': 'Nazarudin', 'Initials': 'N', 'LastName': 'Safian', 'Affiliation': 'Department of Community Health, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norazirah', 'Initials': 'N', 'LastName': 'Md Nor', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Muhammad', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Liyana', 'Initials': 'NL', 'LastName': 'Saharudin', 'Affiliation': 'Department of Pharmacy, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2019.11.007']
415,31752637,Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial.,"Background The failure of cholesteryl ester transfer protein inhibitor torcetrapib was associated with an off-target increase in plasma aldosterone. We sought to evaluate the impact of evacetrapib on plasma aldosterone level and determine the association between plasma aldosterone level and major adverse cardiovascular events among patients with stable high-risk vascular disease enrolled in the ACCELERATE (Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes) trial. Methods and Results We included all patients with a plasma aldosterone level (N=1624) and determined the impact of evacetrapib exposure compared with placebo on plasma aldosterone levels after 12 months of treatment. Using baseline and postexposure aldosterone levels, hazard ratios for major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, cerebrovascular accident, hospitalization for unstable angina, and revascularization) with increasing quartile of baseline and percentage change in plasma aldosterone level at follow-up were calculated. The average age was 65.2 years, 75.7% were men, 93.7% were hypertensive, 73.3% were diabetic, and 57.6% had a prior myocardial infarction. Baseline plasma aldosterone level (85.2 [43, 150] versus 86.8 [43, 155] pmol/L;  P =0.81) and follow-up percentage change (13.6% [-29, 88] versus 17.9% [-24, 87];  P =0.23) were similar between those who received evacetrapib and placebo. During median follow-up of 28 months, major adverse cardiovascular events occurred in 263 patients (16.2%). The hazard ratios for increasing quartile of baseline or percentage change in plasma aldosterone level at follow-up were not significant for major adverse cardiovascular events. These findings remained consistent when adjusting for significant characteristics. Conclusions Exposure to evacetrapib did not result in significant change in plasma aldosterone levels compared with placebo. Among patients with stable high-risk vascular disease, plasma aldosterone levels were not a predictor for future cardiovascular events. Clinical Trial Registration URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01687998.",2019,"During median follow-up of 28 months, major adverse cardiovascular events occurred in 263 patients (16.2%).","['average age was 65.2\xa0years, 75.7% were men, 93.7% were hypertensive, 73.3% were diabetic, and 57.6% had a prior myocardial infarction', 'patients with stable high-risk vascular disease', 'patients with stable high-risk vascular disease enrolled', 'Patients With High-Risk Vascular Disease']","['placebo', 'evacetrapib', 'evacetrapib and placebo']","['Plasma Aldosterone Levels', 'plasma aldosterone', 'hazard ratios', 'plasma aldosterone levels', 'postexposure aldosterone levels, hazard ratios for major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, cerebrovascular accident, hospitalization for unstable angina, and revascularization', 'Baseline plasma aldosterone level', 'plasma aldosterone level', 'major adverse cardiovascular events']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",263.0,0.194775,"During median follow-up of 28 months, major adverse cardiovascular events occurred in 263 patients (16.2%).","[{'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Divyang R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Brennan', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Kathy E', 'Initials': 'KE', 'LastName': 'Wolski', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ruotolo', 'Affiliation': 'Eli Lilly and Company Indianapolis IN.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McErlean', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Govinda', 'Initials': 'G', 'LastName': 'Weerakkody', 'Affiliation': 'Eli Lilly and Company Indianapolis IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly and Company Indianapolis IN.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre Monash University Melbourne Australia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013790']
416,32086373,Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial.,"BACKGROUND


Poverty, unemployment and substance abuse are inter-related problems. This study evaluated the effectiveness of abstinence-contingent wage supplements in promoting drug abstinence and employment in unemployed adults in outpatient treatment for opioid use disorder.
METHODS


A randomised controlled trial was conducted in Baltimore, MD, from 2014 to 2019. After a 3-month abstinence initiation and training period, participants (n=91) were randomly assigned to a usual care control group that received employment services or to an abstinence-contingent wage supplement group that received employment services plus abstinence-contingent wage supplements. All participants were invited to work with an employment specialist to seek employment in a community job for 12 months. Abstinence-contingent wage supplement participants could earn training stipends for working with the employment specialist and wage supplements for working in a community job, but had to provide opiate and cocaine-negative urine samples to maximise pay.
RESULTS


Abstinence-contingent wage supplement participants provided significantly more opiate and cocaine-negative urine samples than usual care control participants (65% vs 45%; OR=2.29, 95% CI 1.22 to 4.30, p=0.01) during the 12-month intervention. Abstinence-contingent wage supplement participants were significantly more likely to have obtained employment (59% vs 28%; OR=3.88, 95% CI 1.60 to 9.41, p=0.004) and lived out of poverty (61% vs 30%; OR=3.77, 95% CI 1.57 to 9.04, p=0.004) by the end of the 12-month intervention than usual care control participants.
CONCLUSION


Abstinence-contingent wage supplements can promote drug abstinence and employment.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02487745.",2020,"RESULTS


Abstinence-contingent wage supplement participants provided significantly more opiate and cocaine-negative urine samples than usual care control participants (65% vs 45%; OR=2.29, 95% CI 1.22 to 4.30, p=0.01) during the 12-month intervention.","['Baltimore, MD, from 2014 to 2019', 'All participants were invited to work with an employment specialist to seek employment in a community job for 12 months', 'unemployed adults in outpatient treatment for opioid use disorder']","['abstinence-contingent wage supplements', 'Abstinence-contingent wage supplements', 'usual care control group that received employment services or to an abstinence-contingent wage supplement group that received employment services plus abstinence-contingent wage supplements', 'Abstinence-contingent wage supplement participants could earn training stipends for working with the employment specialist and wage supplements for working in a community job']","['lived out of poverty', 'obtained employment', 'opiate and cocaine-negative urine samples']","[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]","[{'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",91.0,0.196901,"RESULTS


Abstinence-contingent wage supplement participants provided significantly more opiate and cocaine-negative urine samples than usual care control participants (65% vs 45%; OR=2.29, 95% CI 1.22 to 4.30, p=0.01) during the 12-month intervention.","[{'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA aholtyn1@jhmi.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Shrinidhi', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Brantley P', 'Initials': 'BP', 'LastName': 'Jarvis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Journal of epidemiology and community health,['10.1136/jech-2020-213761']
417,32291634,The videoscopic view may not be significantly superior to the directly sighted peroral view during Macintosh-style videolaryngoscopy: a randomized equivalence cadaver trial.,"PURPOSE


Videolaryngoscopy is widely believed to give a superior view to that obtained by direct laryngoscopy. Published literature suggests this benefit extends to both hyper-angulated and Macintosh-style videolaryngoscopes. Notwithstanding, our clinical experience shows that the videoscopic view with a Macintosh-style videolaryngoscope is often no different or only marginally better than the directly sighted peroral view.
METHODS


A human cadaver equivalence study was performed in which four experienced laryngoscopists obtained pre-assigned laryngeal views by direct sighting using the single-use Macintosh blades of the GlideScope® Spectrum™ (GS) DirectView Macintosh (DVM) and C-MAC®S videolaryngoscopes. Blinded to the laryngoscopist's view, two independent observers rated the videoscopic view presented on the proximal video monitor at the same time. Directly sighted and videoscopic views obtained by the laryngoscopist and video scorers were recorded on a visual analogue scale (VAS) for each device as the primary outcome measures and compared.
RESULTS


On the VAS, the C-MAC®S videoscopic view revealed only approximately 0.9% more (99% confidence interval [CI], -2.5% to 4.3%) of the laryngeal inlet than the directly sighted view. Using GS DVM, the videoscopic view revealed 6.7% (99% CI, 2.3% to 11.0%) more of the laryngeal inlet than the directly sighted view. Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
CONCLUSION


This study failed to corroborate previously published findings of a clinically significantly improved videoscopic view compared with direct peroral sighting using Macintosh-style videolaryngoscopes. Further study of this class of device is warranted in human subjects.",2020,"Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
","['human subjects', 'A human cadaver equivalence study was performed in which four experienced laryngoscopists obtained pre-assigned laryngeal views by direct sighting using the single-use Macintosh blades of the']",['GlideScope® Spectrum™ (GS) DirectView Macintosh (DVM) and C-MAC®S videolaryngoscopes'],['visual analogue scale (VAS'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2948008', 'cui_str': 'Blade'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0353383,"Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': 'Department of Adult and Emergency Anesthesia, Level 8, Auckland City Hospital, Auckland District Health Board, 2 Park Road, Grafton, Auckland, 1023, New Zealand. gmalpas@icloud.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kovacs', 'Affiliation': 'Department of Emergency Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Mackinnon', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Hung', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Anesthesia, Hawke's Bay Hospital, Camberley, Hastings, New Zealand.""}, {'ForeName': 'J Adam', 'Initials': 'JA', 'LastName': 'Law', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01647-y']
418,32273234,Androgens and Overall Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Docetaxel.,"BACKGROUND


Pre-treatment androgen levels are associated with overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) treated with androgen synthesis inhibitors. The current study sought to determine whether pre-treatment serum androgens predict clinical outcome among patients with metastatic CRPC treated with docetaxel chemotherapy.
MATERIALS AND METHODS


Data were obtained from 1050 men who were chemotherapy-naive prior to treatment with docetaxel, prednisone, and either bevacizumab or placebo (CALGB 90401). Pretreatment serum assays for testosterone, androstenedione, and dehydroepiandrosterone (DHEA) were performed with tandem liquid chromatography-mass spectrometry.
RESULTS


Median values for testosterone, androstenedione, and DHEA were 1.00, 13.50, and 8.12 ng/dL, respectively. The median was used to define the midpoint between low and high values. In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS). In multivariable analysis of all androgens, baseline DHEA was prognostic of ≥ 50% PSA decline from baseline (P = .008). In multivariable analysis adjusting for 10 known prognostic values and prior ketoconazole use for metastatic CRPC, a 10-unit increase in baseline testosterone increased risk of death (hazard ratio, 1.11; 95% confidence interval, 1.01-1.23; P = .039), whereas a 10-unit increase in androstenedione lowered risk of death (hazard ratio, 0.92; 95% confidence interval, 0.88-0.97; P = .001).
CONCLUSION


Consistent with prior studies, higher androstenedione levels in patients with metastatic CRPC treated with docetaxel are associated with improved survival. However pretreatment levels of other androgen levels are associated with varied effects on clinical outcome in chemotherapy-treated patients.",2019,"In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS).","['Data were obtained from 1050 men who were chemotherapy-naive prior to treatment with', 'patients with metastatic CRPC treated with docetaxel chemotherapy', 'Patients', 'CALGB 90401', 'patients with metastatic castration-resistant prostate cancer (CRPC) treated with', 'patients with metastatic CRPC treated with']","['Docetaxel', 'docetaxel', 'androgen synthesis inhibitors', 'docetaxel, prednisone, and either bevacizumab or placebo', 'ketoconazole']","['Median values for testosterone, androstenedione, and DHEA', 'Androgens and Overall Survival', 'overall survival (OS', 'androstenedione levels', 'survival', 'median OS', 'androstenedione lowered risk of death', 'Pretreatment serum assays for testosterone, androstenedione, and dehydroepiandrosterone (DHEA']","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3853002', 'cui_str': 'Androgen Synthesis Inhibitors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0337432', 'cui_str': 'Androstenedione measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",,0.330625,"In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Division of Hematology, Oncology and Transplantation University of Minnesota, Masonic Cancer Center, Minneapolis, MN. Electronic address: ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Middleberg', 'Affiliation': 'NMS Labs, Willow Grove, PA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'Division of Hematology, Oncology and Transplantation University of Minnesota, Masonic Cancer Center, Minneapolis, MN.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.10.002']
419,32292179,The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial.,"BACKGROUND


Evidence-based best practices are the cornerstone to guide optimal cardiopulmonary arrest resuscitation care. Adherence to the American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite advances in resuscitation science and survival improvement over the last decades, only approximately 38% of children survive to hospital discharge after in-hospital cardiac arrest and only 6%-20% after out-of-hospital cardiac arrest.
OBJECTIVE


We investigated whether a mobile app developed as a guide to support and drive CPR providers in real time through interactive pediatric advanced life support (PALS) algorithms would increase adherence to AHA guidelines and reduce the time to initiation of critical life-saving maneuvers compared to the use of PALS pocket reference cards.
METHODS


This study was a randomized controlled trial conducted during a simulation-based pediatric cardiac arrest scenario caused by pulseless ventricular tachycardia (pVT). A total of 26 pediatric residents were randomized into two groups. The primary outcome was the elapsed time in seconds in each allocation group from the onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks. All outcomes were assessed for deviation from AHA guidelines.
RESULTS


Mean time to the first defibrillation attempt (121.4 sec, 95% CI 105.3-137.5) was significantly reduced among residents using the app compared to those using PALS pocket cards (211.5 sec, 95% CI 162.5-260.6, P<.001). With the app, 11 out of 13 (85%) residents initiated chest compressions within 60 seconds from the onset of pVT and 12 out of 13 (92%) successfully defibrillated within 180 seconds. Time to all other defibrillation attempts was reduced with the app. Adherence to the 2018 AHA pVT algorithm improved by approximately 70% (P=.001) when using the app following all CPR sequences of action in a stepwise fashion until return of spontaneous circulation. The pVT rhythm was recognized correctly in 51 out of 52 (98%) opportunities among residents using the app compared to only 19 out of 52 (37%) among those using PALS cards (P<.001). Time to epinephrine injection was similar. Among a total of 78 opportunities, incorrect shock or drug doses occurred in 14% (11/78) of cases among those using the cards. These errors were reduced to 1% (1/78, P=.005) when using the app.
CONCLUSIONS


Use of the mobile app was associated with a shorter time to first and subsequent defibrillation attempts, fewer medication and defibrillation dose errors, and improved adherence to AHA recommendations compared with the use of PALS pocket cards.",2020,"These errors were reduced by 12.8% (1/78, P =.0046) using the app.
","['Twenty-six pediatric residents', 'critically ill patients', 'American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation']","['Mobile Device Tablet App', 'simulation-based pediatric cardiac arrest scenario-pulseless ventricular tachycardia (pVT', 'epinephrine']","['pVT rhythm', 'time elapsed to 1) initiation of chest compression, 2) subsequent defibrillation attempts, and 3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks', 'Mean time', 'elapsed time in seconds']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0876083,"These errors were reduced by 12.8% (1/78, P =.0046) using the app.
","[{'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Lacroix', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Cantais', 'Affiliation': 'Pediatric Emergency Department, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/17792']
420,32275468,Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study.,"PURPOSE


Single-agent PD-1 blockade exhibits limited efficacy in epithelial ovarian cancer (EOC). We evaluated ipilimumab plus nivolumab compared with nivolumab alone in women with persistent or recurrent EOC.
METHODS


Eligibility criteria included measurable disease, 1-3 prior regimens, and platinum-free interval (PFI) < 12 months. Participants were randomly allocated to intravenous nivolumab (every 2 weeks) or induction with nivolumab plus ipilimumab for 4 doses (every 3 weeks), followed by every-2-week maintenance nivolumab for a maximum of 42 doses. The primary null hypothesis was equal probability of objective response within 6 months of random allocation in each arm.
RESULTS


One hundred patients were allocated to receive either nivolumab (n = 49), or nivolumab plus ipilimumab (n = 51), with PFI of < 6 months in 62%. Six (12.2%) responses occurred within 6 months in the nivolumab group and 16 (31.4%) in the nivolumab plus ipilimumab group (odds ratio, 3.28; 85% CI, 1.54 to infinity;  P  = .034). The median progression-free survival (PFS) was 2 and 3.9 months in the nivolumab and nivolumab plus ipilimumab groups, respectively, with a PFI-stratified hazard ratio of 0.53 (95% CI, 0.34 to 0.82); the respective hazard ratio for death was 0.79 (95% CI, 0.44 to 1.42). Grade ≥ 3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths. PD-L1 expression was not significantly associated with response in either treatment group.
CONCLUSION


Compared with nivolumab alone, the combination of nivolumab and ipilimumab in EOC resulted in superior response rate and longer, albeit limited, PFS, with toxicity of the combination regimen comparable to prior reports. Additional combination studies to enhance durability of the dual regimen are warranted.",2020,"3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths.","['Recurrent or Persistent Ovarian Cancer', 'One hundred patients', 'epithelial ovarian cancer (EOC', 'Eligibility criteria included measurable disease, 1-3 prior regimens, and platinum-free interval (PFI) < 12 months', 'women with persistent or recurrent EOC']","['nivolumab', 'nivolumab plus ipilimumab', 'intravenous nivolumab (every 2 weeks) or induction with nivolumab plus ipilimumab', 'nivolumab alone', 'Nivolumab Versus Nivolumab and Ipilimumab']","['adverse events', 'Grade ≥', 'PD-L1 expression', 'median progression-free survival (PFS', 'respective hazard ratio for death']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",100.0,0.189914,"3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths.","[{'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Zamarin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'Biostatistics and Bioinformatics, Clinical Trial Development Division, NRG Oncology, Roswell Park, Buffalo, NY.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Powell', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': ""NRG Oncology Biospecimen Bank-Columbus, Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Feldman', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Gunderson', 'Affiliation': 'Stephenson Cancer Center, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma; Oklahoma City, OK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'AMITA Health Physicians, Hinsdale, IL.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Hagemann', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University, Saint Louis, MO.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khleif', 'Affiliation': 'The Loop Immuno-oncology Laboratory, Lombardi Comprehensive Cancer Center, Georgetown University Medical School, Washington DC.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02059']
421,32120033,'Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea' - Author's reply.,,2020,,"[""rectal and pharyngeal gonorrhoea' - Author's reply""]","['ceftriaxone 500 mg plus azithromycin', 'Gentamicin 240 mg plus azithromycin']",[],"[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}]","[{'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]",[],,0.0151766,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rob', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. Electronic address: filip.rob@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.02.033']
422,32053298,Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis.,"BACKGROUND


More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
METHODS


We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2  of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD).
RESULTS


Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups.
CONCLUSIONS


Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).",2020,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"['patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2  of body-surface area or diffuse pulmonary hemorrhage', 'patients with severe ANCA-associated vasculitis']","['plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group', 'standard-dose regimen or a reduced-dose regimen of oral glucocorticoids', 'glucocorticoids', 'oral glucocorticoids']","['Serious infections', 'Death', 'Death from any cause or ESKD', 'incidence of death or ESKD', 'death from any cause or end-stage kidney disease (ESKD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0151701', 'cui_str': 'Pulmonary hemorrhage (disorder)'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]",,0.369926,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Chen-Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wladimir M', 'Initials': 'WM', 'LastName': 'Szpirt', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Floßmann', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Girard', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Gregorini', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Clark', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Smyth', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Janak Rashme', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Flores-Suárez', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Pusey', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Alina L', 'Initials': 'AL', 'LastName': 'Casian', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Brezina', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mazzetti', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'McAlear', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadhurst', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'David R W', 'Initials': 'DRW', 'LastName': 'Jayne', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1803537']
423,32285810,A responsible patient: from theory to practice on a model of a patient with bronchial asthma.,"OBJECTIVE


Introduction: The medicine of today is focused on personalized aid to a patient, which involves partnership and mutual responsibility between the patient and the doctor. In our reality, the patient believes that the responsibility for the treatment and outcome depends on the doctor in most cases. The aim: Induce the patient to develop responsibility for the course of asthma against the background of EBW or obesity and introducing this program into the practice of family physicians.
PATIENTS AND METHODS


Materials and methods: By design, the study included 75 patients with asthma with varying degrees of severity, persistent course in the remission stage against the background of EBW or obesity. According to the randomization method, the patients were divided into 3 groups: the main group - 30 patients (the use of medication), the comparison group - 30 patients (training in the ""Asthma School""), the 3rd group was controls of 15 patients (basic therapy).
RESULTS


Results: According to the anthropometric study, 75 patients enrolled in the study were found to have EBW or obesity and the mean BMI was 31.67 ± 0.53 kg / m2. It was also found that 20 (66.67%) patients in the main group and 21 (70.00%) patients in the comparison group did not regularly use basic therapy and cancelled or changed the drugs without permission. After the training, 45 patients (76.66%) of the total patients of the main group and the comparison group began to perform respiratory movements with the inhalation device correctly. patients in the main group reduced body weight on an average by 4.5 kg, and BMI from 32.00 kg / m2 changed to 29.7 kg / m2 (p <0.05), although they did not reach 25.0 kg / m2 of the target level because the follow-up period was not long.
CONCLUSION


Conclusion: Only patients in the main group had significant positive changes in asthma control, the patients in the comparison group also had positive dynamics, but it did not show statistically significant differences. The doctor should be interested in the fact that at the first and subsequent visits regarding the disease, in our case it is bronchial asthma, the patient will feel responsible for the disease. Therefore, when communicating with the patient, the physician should focus on this, provide the most complete answers to the patient's questions, provide educational literature and, if necessary, diaries of self-control.",2020,"patients in the main group reduced body weight on an average by 4.5 kg, and BMI from 32.00 kg / m2 changed to 29.7 kg / m2 (p <0.05), although they did not reach 25.0 kg / m2 of the target level because the follow-up period was not long.
","['75 patients enrolled in the study were found to have EBW or obesity and the mean BMI was 31.67 ± 0.53 kg / m2', 'patient with bronchial asthma', '75 patients with asthma with varying degrees of severity, persistent course in the remission stage against the background of EBW or obesity']","['comparison group - 30 patients (training in the ""Asthma School']",['body weight'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",75.0,0.0185145,"patients in the main group reduced body weight on an average by 4.5 kg, and BMI from 32.00 kg / m2 changed to 29.7 kg / m2 (p <0.05), although they did not reach 25.0 kg / m2 of the target level because the follow-up period was not long.
","[{'ForeName': 'Valentyna I', 'Initials': 'VI', 'LastName': 'Velychko', 'Affiliation': 'Odesa National Medical University, Odesa, Ukraine.'}, {'ForeName': 'Yaroslava I', 'Initials': 'YI', 'LastName': 'Venher', 'Affiliation': 'Odesa National Medical University, Odesa, Ukraine.'}, {'ForeName': 'Daria O', 'Initials': 'DO', 'LastName': 'Lahoda', 'Affiliation': 'Odesa National Medical University, Odesa, Ukraine.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
424,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
425,30728457,Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine.,"The aim of this randomized phase-II study was to evaluate the effect of substituting cytarabine by azacitidine in intensive induction therapy of patients with acute myeloid leukemia (AML). Patients were randomized to four induction schedules for two cycles: STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide. Consolidation therapy consisted of allogeneic hematopoietic-cell transplantation or three courses of high-dose cytarabine followed by 2-year maintenance therapy with azacitidine in the azacitidine-arms. AML with CBFB-MYH11, RUNX1-RUNX1T1, mutated NPM1, and FLT3-ITD were excluded and accrued to genotype-specific trials. The primary end point was response to induction therapy. The statistical design was based on an optimal two-stage design applied for each arm separately. During the first stage, 104 patients (median age 62.6, range 18-82 years) were randomized; the study arms PRIOR and CONCURRENT were terminated early due to inefficacy. After randomization of 268 patients, all azacitidine-containing arms showed inferior response rates compared to STANDARD. Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively). The data from this trial do not support the substitution of cytarabine by azacitidine in intensive induction therapy.",2019,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","['104 patients (median age 62.6, range 18-82 years', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'allogeneic hematopoietic-cell transplantation', 'idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine', 'STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide', 'cytarabine by azacitidine']","['Event-free and overall survival', 'inferior response rates', 'response to induction therapy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",268.0,0.0373509,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","[{'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany. richard.schlenk@nct-heidelberg.de.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Herr', 'Affiliation': 'Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'Department of Hematology and Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Derigs', 'Affiliation': 'Department of Internal Medicine III, Hospital Frankfurt-Hoechst, Frankfurt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuendgen', 'Affiliation': 'Department of Hematology, Oncology and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ringhoffer', 'Affiliation': 'Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grießhammer', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology and Oncology, Darmstadt, Municipal Hospital, Darmstadt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Girschikofsky', 'Affiliation': 'Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Internal Medicine III, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': 'Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westermann', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Charité - Campus Virchow Clinic, Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': 'Department of Internal Medicine, Caritas-Krankenhaus Lebach, Lebach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Göhring', 'Affiliation': 'Institute of Human Genetics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Teleanu', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gaidzik', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}]",Leukemia,['10.1038/s41375-019-0395-y']
426,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
427,31322563,Research Use of Ecological Momentary Assessment for Adverse Event Monitoring Following Amyloid-β Results Disclosure.,"As calls for transparency in human subjects research grow, investigators conducting Alzheimer's disease (AD) biomarker research are increasingly required to consider their ethical obligations regarding the return of AD biomarker test results to research participants. When disclosing these test results to potentially vulnerable participants, investigators may face unique challenges to identify adverse events, particularly psychological events. The purpose of this paper is to describe our research team's experience with developing and implementing a process for enhanced adverse event monitoring following the return of amyloid-β (Aβ) imaging results to research participants with mild cognitive impairment (MCI). Ethical and logistical considerations are presented along with preliminary findings from an ongoing randomized controlled trial of Aβ imaging results disclosure in MCI. Following receipt of amyloid imaging results, participants underwent 14 days of adverse event monitoring using ecological momentary assessment (EMA), a strategy to capture health, behaviors, and mood as they occur in participants' natural settings in real time. EMA telephone calls were placed at random during waking hours to screen for mood changes. Investigators were alerted for positive depression, anxiety, suicidal ideation screenings, or for two days of failed call attempts. Preliminary feasibility of twenty-four participants with MCI who participated in EMA mood assessments was successfully completed 83% (SD = 0.4) of the time over 14 days with no alerts for anxiety or depression screening items. EMA, when used with standard adverse event monitoring, is a promising and novel approach to maximize early detection of negative psychological reactions following AD biomarker results disclosed in research settings.",2019,"EMA, when used with standard adverse event monitoring, is a promising and novel approach to maximize early detection of negative psychological reactions following AD biomarker results disclosed in research settings.","['participants with mild cognitive impairment (MCI', 'twenty-four participants with MCI who participated in EMA mood assessments was successfully completed 83% (SD\u200a=\u200a0.4) of the time over 14 days with no alerts for anxiety or depression screening items']","['EMA', 'ecological momentary assessment (EMA']",[],"[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}]","[{'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",[],24.0,0.0582622,"EMA, when used with standard adverse event monitoring, is a promising and novel approach to maximize early detection of negative psychological reactions following AD biomarker results disclosed in research settings.","[{'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'Mattos', 'Affiliation': 'Acute and Specialty Care, University of Virginia School of Nursing, Charlottesville, VA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Departments of Health and Community Systems, Epidemiology and Biostatistics, University of Pittsburgh School of Nursing, Graduate School of Public Health and Clinical Translational Science Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Beach', 'Affiliation': 'University Center for Social & Urban Research, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Knox', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine and Gerontology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Parker', 'Affiliation': 'Center for Bioethics & Health Law, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan, School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schulz', 'Affiliation': 'Departments of Psychiatry, Epidemiology, Sociology, Psychology, Community Health, Nursing, Health and Rehabilitation Sciences; University Center for Social and Urban Research; Center for Caregiving Research, Policy and Training; Geriatric Education Center of Pennsylvania; Aging Institute of UPMC Senior Services, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tamres', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190091']
428,31800420,Autologous BPTB ACL Reconstruction Results in Lower Failure Rates Than ACL Repair with and without Synthetic Augmentation at 30 Years of Follow-up: A Prospective Randomized Study.,"BACKGROUND


The aim of this study was to compare the 30-year follow-up results after treatment of anterior cruciate ligament (ACL) ruptures with 3 different surgical procedures.
METHODS


A total of 150 patients with acute rupture of the ACL who were managed between 1986 and 1988 were randomized into 1 of 3 open repair methods: acute primary repair (n = 49), acute repair with a synthetic ligament augmentation device (LAD) (n = 50), or reconstruction with an autologous bone-patellar tendon-bone (BPTB) graft with retention of the ACL remnants (n = 51). The 30-year follow-up included evaluation of clinical findings, the Tegner and Lysholm questionnaires, radiographic examination, and registration of revisions and knee arthroplasties.
RESULTS


A total of 113 patients (75%) were available for the follow-up evaluation; 39 patients were in the primary repair group, 39 in the LAD group, and 35 in the BPTB group. Through telephone calls and investigation of patient medical records, 40 of these patients were excluded from further analyses because of revision surgery, knee arthroplasty in the involved or contralateral knee, or ACL reconstruction in the contralateral knee. One patient in the BPTB group had undergone revision ACL reconstruction compared with 12 in the primary repair group (p = 0.002) and 9 in the LAD group (p = 0.015). Seven patients had undergone knee arthroplasty in the involved knee, with no significant difference among the groups. In the remaining patients, no significant differences were found among the 3 groups with regard to range of motion, laxity, or Tegner and Lysholm scores. Radiographic evidence of osteoarthritis, defined as an Ahlbäck grade of 2 through 5, was found in 42% of the operatively treated knees, with no significant differences among the groups.
CONCLUSIONS


In the present 30-year follow-up results of a randomized controlled study, the BPTB graft augmented with the remnants of the ruptured ligament provided superior results with regard to the number of revisions compared with both the primary repair and LAD groups. No significant differences were found with respect to range of motion, laxity, activity, function, radiographic evidence of osteoarthritis, and knee arthroplasties.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"No significant differences were found with respect to range of motion, laxity, activity, function, radiographic evidence of osteoarthritis, and knee arthroplasties.
","['patient medical records, 40 of these patients were excluded from further analyses because of revision surgery, knee arthroplasty in the involved or contralateral knee, or ACL reconstruction in the contralateral knee', 'anterior cruciate ligament (ACL) ruptures with 3 different surgical procedures', '150 patients with acute rupture of the ACL who were managed between 1986 and 1988', '113 patients (75%) were available for the follow-up evaluation; 39 patients were in the primary repair group, 39 in the LAD group, and 35 in the BPTB group']","['ACL Repair with and without Synthetic Augmentation', '3 open repair methods: acute primary repair (n = 49), acute repair with a synthetic ligament augmentation device (LAD) (n = 50), or reconstruction with an autologous bone-patellar tendon-bone (BPTB) graft with retention of the ACL remnants', 'Autologous BPTB ACL Reconstruction']","['Tegner and Lysholm questionnaires, radiographic examination, and registration of revisions and knee arthroplasties', 'range of motion, laxity, activity, function, radiographic evidence of osteoarthritis, and knee arthroplasties', 'undergone knee arthroplasty', 'range of motion, laxity, or Tegner and Lysholm scores', 'Radiographic evidence of osteoarthritis', 'undergone revision ACL reconstruction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]",1988.0,0.044169,"No significant differences were found with respect to range of motion, laxity, activity, function, radiographic evidence of osteoarthritis, and knee arthroplasties.
","[{'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Sporsheim', 'Affiliation': 'Department of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Gifstad', 'Affiliation': 'Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Trond Olav', 'Initials': 'TO', 'LastName': 'Lundemo', 'Affiliation': 'Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Engebretsen', 'Affiliation': 'Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Strand', 'Affiliation': 'Department of Orthopaedic Surgery, Haraldsplass Deacon Hospital, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mølster', 'Affiliation': 'Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jon Olav', 'Initials': 'JO', 'LastName': 'Drogset', 'Affiliation': 'Department of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00098']
429,31800425,Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels.,"BACKGROUND


Tranexamic acid (TXA) is an antifibrinolytic drug. Topical administration of TXA during total knee arthroplasty (TKA) is favored for certain patients because of concerns about thrombotic complications, despite a lack of supporting literature. We compared local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA between patients who received intravenous (IV) TXA and those who received topical TXA.
METHODS


Seventy-six patients scheduled for TKA were enrolled in this randomized double-blinded study. The IV group received 1.0 g of IV TXA before tourniquet inflation and again 3 hours later; a topical placebo was administered 5 minutes before final tourniquet release. The topical group received an IV placebo before tourniquet inflation and again 3 hours later; 3.0 g of TXA was administered topically 5 minutes before final tourniquet release. Peripheral and wound blood samples were collected to measure levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA.
RESULTS


At 1 hour after tourniquet release, systemic PAP levels were comparable between the IV group (after a single dose of IV TXA) and the topical group. At 4 hours after tourniquet release, the IV group had lower systemic PAP levels than the topical group (mean and standard deviation, 1,117.8 ± 478.9 µg/L versus 1,280.7 ± 646.5 µg/L; p = 0.049), indicative of higher antifibrinolytic activity after the second dose. There was no difference in PF1.2 levels between groups, indicating that there was no increase in thrombin generation. The IV group had higher TXA levels at all time points (p < 0.001). Four hours after tourniquet release, wound blood IL-6 and TXA levels were higher than systemic levels in both groups (p < 0.001). Therapeutic systemic TXA levels (mean, 7.2 ± 7.4 mg/L) were noted in the topical group. Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
CONCLUSIONS


Given that therapeutic levels were reached with topical TXA and the lack of a major difference in the mechanism of action, coagulation, and fibrinolytic profile between topical TXA and a single dose of IV TXA, it may be a simpler protocol for institutions to adopt the use of a single dose of IV TXA when safety is a concern.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","['Seventy-six patients scheduled for TKA', 'Total Knee Replacement', 'total knee arthroplasty (TKA']","['Tranexamic acid (TXA', 'IV TXA', 'IV placebo', 'intravenous (IV) TXA', 'topical placebo', 'Topical and Intravenous Tranexamic Acid', 'topical TXA', 'TXA']","['thrombin generation', 'antifibrinolytic activity', 'local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA', 'higher TXA levels', 'wound blood IL-6 and TXA levels', 'systemic PAP levels', 'Peripheral and wound blood samples', 'mechanism of action, coagulation, and fibrinolytic profile', 'Calculated blood loss and the length of the hospital stay', 'Therapeutic systemic TXA levels', 'PF1.2 levels', 'Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels', 'levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0003304', 'cui_str': 'Antifibrinolysins'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005768'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1524059', 'cui_str': 'mode of action'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0072436', 'cui_str': 'prothrombin activation fragment F1+2'}]",76.0,0.330857,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","[{'ForeName': 'Kethy M', 'Initials': 'KM', 'LastName': 'Jules-Elysee', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Sculco', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Lila R', 'Initials': 'LR', 'LastName': 'Baaklini', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'McLawhorn', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Pickard', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'WeiGe', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Cross', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00258']
430,29655627,Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection.,"BACKGROUND


The single-dose live attenuated vaccine CVD 103-HgR protects against experimental Vibrio cholerae infection in cholera-naïve adults for at least 6 months after vaccination. While vaccine-induced vibriocidal seroconversion is associated with protection, vibriocidal titers decline rapidly from their peak 1-2 weeks after vaccination. Although vaccine-induced memory B cells (MBCs) might mediate sustained protection in individuals without detectable circulating antibodies, it is unknown whether oral cholera vaccination induces a MBC response.
METHODS


In a study that enrolled North American adults, we measured lipopolysaccharide (LPS)- and cholera toxin (CtxB)-specific MBC responses to PXVX0200 (derived from the CVD 103-HgR strain) and assessed stool volumes following experimental Vibrio cholerae infection. We then evaluated the association between vaccine-induced MBC responses and protection against cholera.
RESULTS


There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
DISCUSSION


Oral cholera vaccination induces antigen-specific MBC responses, and the anamnestic LPS-specific responses may contribute to long-term protection and provide correlates of the duration of vaccine-induced protection.
CLINICAL TRIALS REGISTRATION


NCT01895855.",2018,"There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
",['enrolled North American adults'],"['vaccine-induced memory B cells (MBCs', 'Oral cholera vaccination']","['lipopolysaccharide (LPS)- and cholera toxin (CtxB)-specific MBC responses to PXVX0200', 'LPS-specific IgA MBCs and lower post-challenge stool volume', ' CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042199', 'cui_str': 'Cholera vaccination (procedure)'}]","[{'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.229401,"There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Haney', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States. Electronic address: haney_doug@hotmail.com.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lock', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gurwith', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Ishioka', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Cohen', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, University of Vermont, College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Lyon', 'Affiliation': 'Vaccine Testing Center, University of Vermont, College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Wilbur H', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Sztein', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Myron M', 'Initials': 'MM', 'LastName': 'Levine', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Harris', 'Affiliation': 'Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States; Department of Pediatrics, Harvard Medical School, Cambridge, MA, United States. Electronic address: jbharris@mgh.harvard.edu.'}]",Vaccine,['10.1016/j.vaccine.2018.04.011']
431,30867551,Intranasal naloxone rapidly occupies brain mu-opioid receptors in human subjects.,"Nasal spray formulations of naloxone, a mu-opioid receptor (MOR) antagonist, are currently used for the treatment of opioid overdose. They may have additional therapeutic utility also in the absence of opioid agonist drugs, but the onset and duration of action at brain MORs have been inadequately characterized to allow such projections. This study provides initial characterization of brain MOR availability at high temporal resolution following intranasal (IN) naloxone administration to healthy volunteers in the absence of a competing opioid agonist. Fourteen participants were scanned twice using positron emission tomography (PET) and [ 11 C]carfentanil, a selective MOR agonist radioligand. Concentrations of naloxone in plasma and MOR availability (relative to placebo) were monitored from 0 to 60 min and at 300-360 min post naloxone. Naloxone plasma concentrations peaked at ~20 min post naloxone, associated with slightly delayed development of brain MOR occupancy (half of peak occupancy reached at ~10 min). Estimated peak occupancies were 67 and 85% following 2 and 4 mg IN doses, respectively. The estimated half-life of occupancy disappearance was ~100 min. The rapid onset of brain MOR occupancy by IN naloxone, evidenced by the rapid onset of its action in opioid overdose victims, was directly documented in humans for the first time. The employed high temporal-resolution PET method establishes a model that can be used to predict brain MOR occupancy from plasma naloxone concentrations. IN naloxone may have therapeutic utility in various addictions where brain opioid receptors are implicated, such as gambling disorder and alcohol use disorder.",2019,Naloxone plasma concentrations peaked at ~20 ,"['healthy volunteers', 'human subjects', 'Fourteen participants were']","['naloxone', 'scanned twice using positron emission tomography (PET) and [ 11 C]carfentanil, a selective MOR agonist radioligand', 'intranasal (IN) naloxone', 'naloxone, a mu-opioid receptor (MOR) antagonist', 'Intranasal naloxone']","['Naloxone plasma concentrations', 'brain MOR occupancy', 'Estimated peak occupancies', 'plasma and MOR availability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0441633'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0066908', 'cui_str': 'Receptors, mu'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",14.0,0.0381696,Naloxone plasma concentrations peaked at ~20 ,"[{'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Johansson', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland. Jarkko.johansson@umu.se.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Hirvonen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ekblad', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Valtteri', 'Initials': 'V', 'LastName': 'Kaasinen', 'Affiliation': 'Division of Clinical Neurosciences, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Rajasilta', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Semi', 'Initials': 'S', 'LastName': 'Helin', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Tuisku', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Sirén', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Pennanen', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Opiant Pharmaceuticals Inc., Santa Monica, CA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Crystal', 'Affiliation': 'Opiant Pharmaceuticals Inc., Santa Monica, CA, USA.'}, {'ForeName': 'Petri J', 'Initials': 'PJ', 'LastName': 'Vainio', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Alho', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0368-x']
432,30531191,Ahmed Glaucoma Valve Revision Versus Visco-Trabeculotomy After Failed Ahmed Glaucoma Valve in Refractory Pediatric Glaucoma.,"PURPOSE


To compare the outcome of the intraocular pressure (IOP) of Ahmed glaucoma valve (AGV) revision to visco-trabeculotomy (VT) in children's eyes with failed AGV.
PATIENTS AND METHODS


A prospective randomized study conducted on 41 children (41 eyes) with uncontrolled glaucoma with an AGV presenting to the pediatric ophthalmology clinic of Mansoura Ophthalmic Center between 2011 and 2016. Study eyes were randomized to AGV revision or VT. Success (true and qualified) (IOP<21 mm Hg without any sight-threatening complications) was studied at the end of 12-month follow-up. Operative complications were noted. The primary outcome was the IOP before and after the study intervention.
RESULTS


The mean±SD age of the study children was 7.9±2.6 and 7.7±2.6 years in the AGV revision (19 eyes) and VT groups (22 eyes), respectively (P=0.654). The most common glaucoma type was primary congenital glaucoma in both groups. The mean±SD of the duration between the last glaucoma procedure and the current study intervention was 24.9±4.8 and 25.2±5.8 months in the AGV revision and VT groups, respectively. The mean±SD preoperative IOP and at 12-month follow-up was 32.1±3.2 and 23.2±3.5 mm Hg in the AGV revision group and was 33.3±2.2 and 20.0±3.5 mm Hg in the VT group. The total success rates at 12 months were 31.6% and 63.7% in the AGV revision and VT groups, respectively.
CONCLUSIONS


Both VT and AGV revision are reasonably successful and safe interventions for refractory childhood glaucoma after the failure of an AGV. VT is significantly better than AGV revision, resulting in higher success rates and a decrease in IOP-lowering medication use.",2019,"VT is significantly better than AGV revision, resulting in higher success rates and a decrease in IOP-lowering medication use.","['41 children (41 eyes) with uncontrolled glaucoma with an AGV presenting to the pediatric ophthalmology clinic of Mansoura Ophthalmic Center between 2011 and 2016', ""children's eyes with failed AGV""]","['VT and AGV revision', 'intraocular pressure (IOP) of Ahmed glaucoma valve (AGV) revision to visco-trabeculotomy (VT', 'AGV revision or VT', 'Glaucoma Valve Revision Versus Visco-Trabeculotomy']","['IOP', 'Success (true and qualified', 'total success rates', 'Operative complications']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1628978', 'cui_str': 'Pediatric ophthalmology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}]","[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",41.0,0.0418147,"VT is significantly better than AGV revision, resulting in higher success rates and a decrease in IOP-lowering medication use.","[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elwehidy', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Mansoura University, Mansoura.'}, {'ForeName': 'Amani E', 'Initials': 'AE', 'LastName': 'Badawi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Mansoura University, Mansoura.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Mansoura University, Mansoura.'}, {'ForeName': 'Nader H L', 'Initials': 'NHL', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001149']
433,32179197,Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial.,"OBJECTIVES


To investigate the effects of lower limb strength training in addition to neuromuscular exercise and education (ST + NEMEX-EDU) compared to neuromuscular exercise and education alone (NEMEX-EDU) on self-reported physical function in patients with knee osteoarthritis (KOA).
DESIGN


Patient-blinded, parallel-group randomized controlled trial (RCT).
METHODS


The trial included 90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement. Both groups exercised twice weekly for 12 weeks. Additional strength training consisted of a single, fatiguing knee extension set (30-60RM) before four sets of leg-press (8-12RM). Primary outcome was the between-group difference on the subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ) at 12 weeks. Secondary outcomes included KOOS symptoms, pain, function in sport and recreation, and quality of life, 40 m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events.
RESULTS


There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference -1.15 (-6.78 to 4.48). Except for the stair climb test, which demonstrated an adjusted mean difference of 1.15 (0.09-2.21) in favor of ST + NEMEX-EDU, all other outcomes showed no statistically significant between-group differences. Neither group improved leg extension power.
CONCLUSION


The addition of lower-limb strength training, using a low-dose approach, to neuromuscular exercise and education carried no additional benefits on self-reported physical function or on most secondary outcomes. Both groups displayed similar improvements at 12-week follow-up. Hence, the current low-dose strength training approach provided no additional clinical value in this group of KOA patients. Trial identifier (ClinicalTrials.gov): NCT03215602.",2020,There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference,"['patients with knee osteoarthritis (KOA', '90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement', 'patients with knee osteoarthritis in secondary care ']","['neuromuscular exercise and education (ST+NEMEX-EDU', 'Low-dose strength training', 'lower limb strength training', 'neuromuscular exercise and education', 'neuromuscular exercise and education alone (NEMEX-EDU']","['KOOS ADL', 'KOOS symptoms, pain, function during sport and recreation, and quality of life, 40m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events', 'subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ', 'leg extension power']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2927798', 'cui_str': 'Nemex'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.118503,There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference,"[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Holm', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark. Electronic address: pamh@regionsjaelland.dk.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals, Næstved, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wernbom', 'Affiliation': 'Center for Health and Performance, Department of Food and Nutrition and Sport Science, University of Gothenburg, Gothenburg, Sweden; Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.839']
434,32281095,Investigation of a New Catheter on Relieving Pain During Male Cystoscopy - A Randomized Clinical Trial.,"PURPOSE


To investigate the pain intensity and tolerability of a new catheter applied to urethral surface anesthesia during rigid cystoscopy in male patients, and explore the prospects of its application and the anesthetic method in hospitals at primary levels.
MATERIALS AND METHODS


252 adult male patients were randomly divided into the experimental group and the control group.1% lidocaine solution was irrigated into the posterior urethra of the experimental group using the new catheter before cystoscopy, while the control group was administered with lidocaine gel. Both groups were assessed by visual analogue scale(VAS) with their pain perceived during administration of lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group) (T1),during the insertion of cystoscope (T2),at the beginning of cystoscopy (T3),The third minute of cystoscopy (T4), during the first urination after the procedure (T5), as well with the maximum pain(Pmax) perceived during the whole procedure. The fluctuations of blood pressure and heart rate in each group before, after and during the procedure were recorded, and the anesthesia costs in both groups were calculated.
RESULTS


Except a slightly higher score in T1, the scores of VAS in experimental group were lower than those of control group in T2,T3 and T4. The Pmax of the control group was 4.92(SD=1.20), which was higher than in the experimental group of 3.89(SD=0.95,P<0.01).There was no significant difference on blood pressure variation in both groups. While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups. The anesthesia cost of the experimental group is about 1.53 dollars, with 1.75 dollars lower than that of the control group.
CONCLUSION


It is tolerable and beneficial to apply the new catheter for male urethral anesthesia. It can significantly relieve the pain during rigid cystoscopy in male patients, and is low in cost and easy in operation. Thus this method is worth being recommended to hospitals, especially at community hospitals or primary hospitals.",2020,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","['252 adult male patients', 'male urethral anesthesia', 'male patients']","['New Catheter', 'control group.1% lidocaine solution', 'lidocaine gel', 'new catheter applied to urethral surface anesthesia during rigid cystoscopy', 'lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group']","['scores of VAS', 'heart rate variation', 'anesthesia costs', 'pain intensity and tolerability', 'pain', 'anesthesia cost', 'fluctuations of blood pressure and heart rate', 'blood pressure variation', 'Relieving Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",252.0,0.0267797,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","[{'ForeName': 'Xiong Yong', 'Initials': 'XY', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China. xiongyongjiang1988@126.com.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Jiaji', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}]",Urology journal,['10.22037/uj.v0i0.5130']
435,32151697,Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses.,"OBJECTIVES


The objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT).
STUDY DESIGN AND SETTING


A Study Within A Trial (SWAT) embedded in a multicenter RCT evaluating three treatments for the frozen shoulder. Participants who provided a mobile telephone number were randomized to either prenotification SMS on the day of the questionnaire mail-out or postnotification SMS 4 days after questionnaire mail-out for the 3-month follow-up. The primary outcome was the proportion of participants who returned a valid questionnaire. A systematic review was undertaken to identify other embedded trials to perform a meta-analysis.
RESULTS


Of the 269 participants, 122/135 (90.4%) returned a valid questionnaire in the prenotification arm and 119/134 (88.8%) in the postnotification arm (difference of -1.6%; 95% CI of difference: -8.9%, 5.7%). There was no difference in time to response (HR = 1.04; 95% CI: 0.80 to 1.34) or need for additional reminders (OR = 0.71; 95% CI: 0.43 to 1.17). Meta-analysis of two RCTs showed no difference in response rates between prenotification and postnotification reminders (OR = 0.78 95% CI: 0.42 to 1.45).
CONCLUSION


Timing of SMS reminders did not improve response rates and time to response or affect the need for additional reminders.",2020,"Timing of SMS reminders did not improve response rates, time to response or affect the need for additional reminders.",['Participants who provided a mobile telephone number'],"['pre-notification SMS on the day of the questionnaire mail-out or post-notification SMS', 'SMS reminders']","['trial participant questionnaire response', 'valid questionnaire', 'postal questionnaire return rates', 'response rates', 'response rates, time to response or affect the need for additional reminders', 'time to response', 'proportion of participants who returned a valid questionnaire']","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",269.0,0.247365,"Timing of SMS reminders did not improve response rates, time to response or affect the need for additional reminders.","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Partha Sarathy', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'STRIVE, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.'}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK. Electronic address: stephen.brealey@york.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK; STRIVE, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.001']
436,32283048,An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the STRoke Interactive Virtual thErapy (STRIVE) intervention on upper-extremity clinical outcomes in community-dwelling stroke survivors.
DESIGN


Assessor-blinded randomized controlled trial.
SETTING


Study screening and testing was conducted in a university clinic. Participants completed the virtual therapy (VT) intervention in a community-based stroke support group setting.
PARTICIPANTS


Of 124 stroke survivors initially assessed, 60 participants were recruited (time poststroke, 13.4±8.9 y). Participants were allocated to either VT or control group using a block randomization design and were stratified by sex.
INTERVENTIONS


Participants were randomized to receive 8 weeks of VT or usual care. The intervention consisted of approximately 45 minutes of twice weekly VT training on the Jintronix Rehabilitation System.
MAIN OUTCOME MEASURES


Between-group differences in the Fugl-Meyer Upper Extremity scale and Action Research Arm Test score were joint primary outcomes in this study.
RESULTS


Significant between-group differences for the Fugl-Meyer Upper Extremity scale were seen at the end of the intervention (F 1, 1 =5.37, P=.02, d=0.41). No significant differences were observed with the Action Research Arm Test. No adverse events were reported.
CONCLUSIONS


We demonstrated clinically meaningful improvements in gross upper extremity motor function and use of the affected arm after a VT intervention delivered via a community-based stroke support group setting. This data adds to the contexts in which VT can be used to improve upper limb function. Use of VT in community-based rehabilitation in chronic stroke recovery is supported.",2020,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","['community-dwelling stroke survivors', 'Study screening and testing was conducted in a University clinic', 'Of 124 stroke survivors initially assessed, 60 participants were recruited (time post-stroke 13.4 ± 8.9 years']","['virtual therapy (VT) intervention in a community-based stroke support group setting', 'VT training', 'VT intervention delivered via a community-based stroke support group setting', 'VT', 'STRoke Interactive Virtual thErapy (STRIVE) intervention', 'VT or usual care', 'innovative STRoke Interactive Virtual thErapy (STRIVE) online platform']","['1) Fugl-Meyer Upper Extremity scale, and 2) Action Research Arm Test score', 'Fugl-Meyer Upper Extremity scale', 'adverse events']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0902791,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia; Faculty of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; National Health and Medical Research Council Stroke Rehabilitation and Brain Recovery Centre of Research Excellence, The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Bird', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Launceston, Australia; Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'Silverline Research, Brisbane, Australia; EuroMov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia; Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore. Electronic address: weipeng.teo@nie.edu.sg.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.011']
437,31720826,Response to Letter to the Editor: Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial.,,2020,,['caregivers of cancer patients'],[],[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0945526,,"[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital and University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark. line.lund.01@regionh.dk.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital and University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital and University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sengelov', 'Affiliation': 'The Department of Oncology, Herlev and Gentofte Hospital and University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital and University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05127-y']
438,30538099,Case-only Methods Identified Genetic Loci Predicting a Subgroup of Men with Reduced Risk of High-grade Prostate Cancer by Finasteride.,"In the Prostate Cancer Prevention Trial (PCPT), genotypes that may modify the effect of finasteride on the risk of prostate cancer have not been identified. Germline genetic data from 1,157 prostate cancer cases in PCPT were analyzed by case-only methods. Genotypes included 357 SNPs from 83 candidate genes in androgen metabolism, inflammation, circadian rhythm, and other pathways. Univariate case-only analysis was conducted to evaluate whether individual SNPs modified the finasteride effect on the risk of high-grade and low-grade prostate cancer. Case-only classification trees and random forests, which are powerful machine learning methods with resampling-based controls for model complexity, were employed to identify a predictive signature for genotype-specific treatment effects. Accounting for multiple testing, a single SNP in  SRD5A1  gene (rs472402) significantly modified the finasteride effect on high-grade prostate cancer (Gleason score > 6) in PCPT (family-wise error rate < 0.05). Men carrying GG genotype at this locus had a 55% reduction of the risk in developing high-grade cancer when assigned to finasteride (RR = 0.45; 95% confidence interval, 0.27-0.75). Additional effect-modifying SNPs with moderate statistical significance were identified by case-only trees and random forests. A prediction model built by the case-only random forest method with 28 selected SNPs classified 37% of PCPT men to have reduced risk of high-grade prostate cancer when taking finasteride, while the others have increased risk. In conclusion, case-only methods identified SNPs that modified the effect of finasteride on the risk of high-grade prostate cancer and predicted a subgroup of men who had reduced cancer risk by finasteride.",2019,"Accounting for multiple testing, a single SNP in  SRD5A1  gene (rs472402) significantly modified the finasteride effect on high-grade prostate cancer (Gleason score > 6) in PCPT (family-wise error rate < 0.05).","['1,157 prostate cancer cases in PCPT', 'Genotypes included 357 SNPs from 83 candidate genes in androgen metabolism, inflammation, circadian rhythm, and other pathways']","['finasteride', 'Finasteride']",['risk of high-grade prostate cancer'],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]","[{'cui': 'C0060389', 'cui_str': 'Finasteride'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",1157.0,0.0408498,"Accounting for multiple testing, a single SNP in  SRD5A1  gene (rs472402) significantly modified the finasteride effect on high-grade prostate cancer (Gleason score > 6) in PCPT (family-wise error rate < 0.05).","[{'ForeName': 'James Y', 'Initials': 'JY', 'LastName': 'Dai', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. jdai@fredhutch.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'LeBlanc', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'University of Colorado Denver School of Medicine, Denver, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'The Cancer Therapy and Research Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0284']
439,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
440,32281579,"Short-Term Efficacy (at 12 Weeks) and Long-Term Safety (up to 52 Weeks) of Omega-3 Free Fatty Acids (AZD0585) for the Treatment of Japanese Patients With Dyslipidemia　- A Randomized, Double-Blind, Placebo-Controlled, Phase III Study.","BACKGROUND


This study is the first to evaluate the short-term efficacy and long-term safety of AZD0585, a mixture of omega-3 free fatty acids, in Japanese patients with dyslipidemia.Methods and Results:In this randomized double-blind placebo-controlled Phase III study, 383 patients were randomized to 2 g AZD0585, 4 g AZD0585, or placebo once daily for 52 weeks. Eligible patients had low-density lipoprotein cholesterol (LDL-C) levels controlled regardless of statin use, and triglyceride levels between 150 and 499 mg/dL. The least-squares (LS) mean percentage changes in triglyceride concentrations from baseline to the 12-week endpoint (mean of measurements at Weeks 10 and 12) in the 2 and 4 g AZD0585 and placebo groups were -15.57%, -21.75%, and 11.15% respectively (P<0.0001 for both AZD0585 doses vs. placebo). No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein (Apo) B were found with AZD0585. High-density lipoprotein cholesterol (HDL-C) was slightly increased and very low-density lipoprotein cholesterol, non-HDL-C, ApoC-II, and ApoC-III were decreased with AZD0585 compared with placebo at the 12-week endpoint. Lipid profiles up to Week 52 were consistent with those up to the 12-week endpoint. No clinically important safety concerns were raised.
CONCLUSIONS


AZD0585 significantly decreased serum triglyceride levels compared with placebo at the 12-week endpoint and was generally safe and well tolerated in Japanese patients with dyslipidemia.",2020,"No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein","['Japanese patients with dyslipidemia', 'Japanese Patients With Dyslipidemia\u3000', '383 patients']","['AZD0585, a mixture of omega-3 free fatty acids', 'AZD0585, 4 g AZD0585, or placebo', 'placebo', 'Omega-3 Free Fatty Acids (AZD0585', 'Placebo']","['serum triglyceride levels', 'High-density lipoprotein cholesterol (HDL-C', 'safe and well tolerated', 'low-density lipoprotein cholesterol, non-HDL-C, ApoC-II, and ApoC-III', 'triglyceride concentrations', 'total cholesterol, LDL-C, and LDL-C/apolipoprotein', 'low-density lipoprotein cholesterol (LDL-C) levels controlled regardless of statin use, and triglyceride levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0245042', 'cui_str': 'apolipoprotein C-II (Toronto)'}, {'cui': 'C4048315', 'cui_str': 'ApoC-III'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",383.0,0.139741,"No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein","[{'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Niwa', 'Affiliation': 'Niwa Family Clinic.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Hakoda', 'Affiliation': 'Nippon Kokan Fukuyama Hospital.'}, {'ForeName': 'Fumiki', 'Initials': 'F', 'LastName': 'Oh', 'Affiliation': 'Shindenhigashi Clinic.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kajimoto', 'Affiliation': 'Senrichuo Ekimae Clinic.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Fukui', 'Affiliation': 'Olive Takamatsu Medical Clinic.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lundström', 'Affiliation': 'Global Medicine Development, AstraZeneca Gothenburg.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0358']
441,32194148,Prior event rate ratio adjustment produced estimates consistent with randomized trial: a diabetes case study.,"OBJECTIVES


Electronic health records (EHR) provide a valuable resource for assessing drug side-effects, but treatments are not randomly allocated in routine care creating the potential for bias. We conduct a case study using the Prior Event Rate Ratio (PERR) Pairwise method to reduce unmeasured confounding bias in side-effect estimates for two second-line therapies for type 2 diabetes, thiazolidinediones, and sulfonylureas.
STUDY DESIGN AND SETTINGS


Primary care data were extracted from the Clinical Practice Research Datalink (n = 41,871). We utilized outcomes from the period when patients took first-line metformin to adjust for unmeasured confounding. Estimates for known side-effects and a negative control outcome were compared with the A Diabetes Outcome Progression Trial (ADOPT) trial (n = 2,545).
RESULTS


When on metformin, patients later prescribed thiazolidinediones had greater risks of edema, HR 95% CI 1.38 (1.13, 1.68) and gastrointestinal side-effects (GI) 1.47 (1.28, 1.68), suggesting the presence of unmeasured confounding. Conventional Cox regression overestimated the risk of edema on thiazolidinediones and identified a false association with GI. The PERR Pairwise estimates were consistent with ADOPT: 1.43 (1.10, 1.83) vs. 1.39 (1.04, 1.86), respectively, for edema, and 0.91 (0.79, 1.05) vs. 0.94 (0.80, 1.10) for GI.
CONCLUSION


The PERR Pairwise approach offers potential for enhancing postmarketing surveillance of side-effects from EHRs but requires careful consideration of assumptions.",2020,"When on metformin, patients later prescribed thiazolidinediones had greater risks of oedema, HR 95%CI 1.38 (1.13,1.68) and gastrointestinal (GI) side-effects 1.47 (1.28,1.68), suggesting the presence of unmeasured confounding.",[],"['metformin', 'ADOPT']","['risks of oedema, HR 95%CI', 'Prior Event Rate Ratio (PERR']",[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1842073', 'cui_str': 'Prolonged Electroretinal Response Suppression'}]",,0.0505379,"When on metformin, patients later prescribed thiazolidinediones had greater risks of oedema, HR 95%CI 1.38 (1.13,1.68) and gastrointestinal (GI) side-effects 1.47 (1.28,1.68), suggesting the presence of unmeasured confounding.","[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Rodgers', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK. Electronic address: L.R.Rodgers@exeter.ac.uk.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Dennis', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'NIHR Exeter Clinical Research Facility, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Mounce', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fisher', 'Affiliation': 'IQVIA, London UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Henley', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.007']
442,31039579,Neural predictors of treatment response to brain stimulation and psychological therapy in depression: a double-blind randomized controlled trial.,"Standard depression treatments, including antidepressant medication and cognitive behavioural therapy (CBT), are ineffective for many patients. Prefrontal transcranial direct current stimulation (tDCS) has been proposed as an alternative treatment, but has shown inconsistent efficacy for depression, and its mechanisms are poorly understood. We recruited unmedicated patients with major depressive disorder (N = 71 approached; N = 39 randomised) for a mechanistic, double-blind, randomized controlled trial consisting of eight weekly sessions of prefrontal tDCS administered to the left prefrontal cortex prior to CBT. We probed (1) whether tDCS improved the efficacy of CBT relative to sham stimulation; and (2) whether neural measures predicted clinical response. We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement. Repeating our analyses of symptom outcome splitting the sample according to this biomarker revealed that tDCS was significantly superior to sham in individuals with high left prefrontal cortex activation at baseline; we also show 86% accuracy in predicting clinical response using this measure. Exploratory analyses revealed several other regions where activation at baseline was associated with subsequent response to CBT, irrespective of tDCS. This mechanistic trial revealed variable, but predictable, clinical effects of prefrontal tDCS combined with CBT for depression. We have discovered a potential explanation for this variability: individual differences in baseline activation of the region stimulated. Such a biomarker could potentially be used to pre-select patients for trials and, eventually, in the clinic.",2019,"We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement.","['unmedicated patients with major depressive disorder (N\u2009=\u200971 approached; N\u2009=\u200939 randomised', 'depression']","['antidepressant medication and cognitive behavioural therapy (CBT', 'Prefrontal transcranial direct current stimulation (tDCS', 'prefrontal tDCS', 'brain stimulation and psychological therapy', 'tDCS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}]",[],,0.175638,"We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement.","[{'ForeName': 'Camilla L', 'Initials': 'CL', 'LastName': 'Nord', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK. Camilla.Nord@mrc-cbu.cam.ac.uk.'}, {'ForeName': 'D Chamith', 'Initials': 'DC', 'LastName': 'Halahakoon', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Limbachya', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Charpentier', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Níall', 'Initials': 'N', 'LastName': 'Lally', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Walsh', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Leibowitz', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0401-0']
443,32280055,Resistant Starch Has No Effect on Appetite and Food Intake in Individuals with Prediabetes.,"BACKGROUND


Type 2 resistant starch (RS2) has been shown to improve metabolic health outcomes and may increase satiety and suppress appetite and food intake in humans.
OBJECTIVE


This study assessed whether 12 weeks of daily RS2 supplementation could influence appetite perception, food intake, and appetite-related gut hormones in adults with prediabetes, relative to the control (CTL) group.
DESIGN


The study was a randomized controlled trial and analysis of secondary study end points.
PARTICIPANTS/SETTING


Sixty-eight adults (body mass index ≥27) aged 35 to 75 years with prediabetes were enrolled in the study at Pennington Biomedical Research Center (2012 to 2016). Fifty-nine subjects were included in the analysis.
INTERVENTION


Participants were randomized to consume 45 g/day of high-amylose maize (RS2) or an isocaloric amount of the rapidly digestible starch amylopectin (CTL) for 12 weeks.
MAIN OUTCOME MEASURES


Subjective appetite measures were assessed via visual analogue scale and the Eating Inventory; appetite-related gut hormones (glucagon-like peptide 1, peptide YY, and ghrelin) were measured during a standard mixed-meal test; and energy and macronutrient intake were assessed by a laboratory food intake (buffet) test, the Remote Food Photography Method, and SmartIntake app.
STATISTICAL ANALYSES PERFORMED


Data were analyzed using linear mixed models, adjusting for treatment group and time as fixed effects, with a significance level of α=.05.
RESULTS


RS2 had no effect on subjective measures of appetite, as assessed by visual analogue scale (P>0.05) and the Eating Inventory (P≥0.24), relative to the CTL group. There were no effects of RS2 supplementation on appetite-related gut hormones, including glucagon-like peptide 1 (P=0.61), peptide YY (P=0.34), and both total (P=0.26) and active (P=0.47) ghrelin compared with the CTL. RS2 had no effect on total energy (P=0.30), carbohydrate (P=0.11), protein (P=0.64), or fat (P=0.37) consumption in response to a buffet meal test, relative to the CTL. In addition, total energy (P=0.40), carbohydrate (P=0.15), protein (P=0.46), and fat (P=0.53) intake, as quantified by the Remote Food Photography Method, were also unaffected by RS2, relative to the CTL.
CONCLUSIONS


RS2 supplementation did not increase satiety or reduce appetite and food intake in adults with prediabetes.",2020,"RS2 had no effect on total energy (P=0.30), carbohydrate (P=0.11), protein (P=0.64), or fat (P=0.37) consumption in response to a buffet meal test, relative to the CTL.","['aged 35 to 75 years with prediabetes were enrolled in the study at Pennington Biomedical Research Center (2012 to 2016', 'adults with prediabetes', 'Fifty-nine subjects were included in the analysis', 'Sixty-eight adults (body mass index ≥27', 'adults with prediabetes, relative to the control (CTL) group', 'Individuals with Prediabetes']","['consume 45 g/day of high-amylose maize (RS2) or an isocaloric amount of the rapidly digestible starch amylopectin (CTL', 'daily RS2 supplementation', 'RS2 supplementation', 'Resistant Starch']","['visual analogue scale (P>0.05) and the Eating Inventory', 'laboratory food intake (buffet) test, the Remote Food Photography Method, and SmartIntake app', 'energy and macronutrient intake', 'appetite-related gut hormones, including glucagon-like peptide 1', 'total energy', 'subjective measures of appetite', 'via visual analogue scale and the Eating Inventory; appetite-related gut hormones (glucagon-like peptide 1, peptide YY, and ghrelin', 'Appetite and Food Intake', 'satiety or reduce appetite and food intake', 'appetite perception, food intake, and appetite-related gut hormones']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005540', 'cui_str': 'Research, Biomedical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002732', 'cui_str': 'Amylose'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0002728', 'cui_str': 'Amylopectin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451139', 'cui_str': 'Eating inventory'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",59.0,0.13312,"RS2 had no effect on total energy (P=0.30), carbohydrate (P=0.11), protein (P=0.64), or fat (P=0.37) consumption in response to a buffet meal test, relative to the CTL.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': ''}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.01.017']
444,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
445,32275482,Effect of storage temperature and duration on concentrations of 27 fungal secondary metabolites spiked into floor dust from an office building.,"Fungi are ubiquitous in environments and produce secondary metabolites that are usually low-molecular-weight organic compounds during growth processes. Dust samples containing these fungal secondary metabolites collected from study sites are often stored in certain temperature conditions for an extended period until laboratory analysis resources are available. However, there is little information on how stable fungal secondary metabolites are over time at different storage temperatures. We examined the stability of 27 fungal secondary metabolites spiked into floor dust samples collected from a moisture-damaged office building. Ninety-five dust aliquots were made from the spiked dust; five replicates were randomly assigned to a baseline (time = 0) and each of the 18 combinations of three temperatures (room temperature, 4 °C, or -80 °C) and six time points (2, 12, 25, 56, 79, and 105 weeks). At the baseline and each subsequent time point, we extracted and analyzed the fungal secondary metabolites from the spiked dust using ultra-performance liquid chromatograph-tandem mass spectrometer. To estimate change in concentration over storage time at each temperature condition, we applied multiple linear regression models with interaction effect between storage temperature and duration. For 10 of the 27 fungal secondary metabolites, the effect of time was significantly (p-values <0.05) or marginally (p-values <0.1) modified by temperature, but not for the remaining 17 metabolites. Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide). We did not observe significant differences between storage at 4 °C, or -80 °C. Storage temperature influenced degradation of fungal secondary metabolites more than storage time. Our study indicates that fungal secondary metabolites, including mycotoxins in floor dust, quickly degrade at room temperature. However, storing dust samples at 4 °C might be adequate given that storing them at -80 °C did not further reduce degradation of fungal secondary metabolites.",2020,"Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide).","['27 fungal secondary metabolites spiked into floor dust samples collected from a moisture-damaged office building', '27 fungal secondary metabolites spiked into floor dust from an office building', 'Ninety-five dust aliquots were made from the spiked dust; five replicates']",[],['degradation of fungal secondary metabolites'],"[{'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442605', 'cui_str': 'Office building'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",[],"[{'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0619027,"Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide).","[{'ForeName': 'Mukhtar', 'Initials': 'M', 'LastName': 'Jaderson', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Morgantown, West Virginia.'}, {'ForeName': 'Ju-Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Morgantown, West Virginia.'}]",Journal of occupational and environmental hygiene,['10.1080/15459624.2020.1734205']
446,32280089,Concentration-Dependent Activity of Hydromethylthionine on Clinical Decline and Brain Atrophy in a Randomized Controlled Trial in Behavioral Variant Frontotemporal Dementia.,"BACKGROUND


Hydromethylthionine is a potent inhibitor of pathological aggregation of tau and TDP-43 proteins.
OBJECTIVE


To compare hydromethylthionine treatment effects at two doses and to determine how drug exposure is related to treatment response in bvFTD.
METHODS


We undertook a 52-week Phase III study in 220 bvFTD patients randomized to compare hydromethylthionine at 200 mg/day and 8 mg/day (intended as a control). The principal outcomes were change on the Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume. Secondary outcomes included Modified Clinical Global Impression of Change (Modified-CGIC). A population pharmacokinetic exposure-response analysis was undertaken in 175 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug.
RESULTS


There were no significant differences between the two doses as randomized. There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes. There were significant exposure-dependent differences at 8 mg/day for FAQ, Modified-CGIC, and whole brain atrophy comparing patients with plasma levels greater than 0.346 ng/ml with having minimal drug exposure. The exposure-response is biphasic with worse outcomes at the high concentrations produced by 200 mg/day.
CONCLUSIONS


Hydromethylthionine has a similar concentration-response profile for effects on clinical decline and brain atrophy at the 8 mg/day dose in bvFTD as recently reported in AD. Treatment responses in bvFTD are predicted to be maximal at doses in the range 20-60 mg/day. A confirmatory placebo-controlled trial is now planned.",2020,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"['220 bvFTD patients', '176 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug', 'Behavioral Variant Frontotemporal Dementia']","['hydromethylthionine', 'Hydromethylthionine', 'placebo']","['Modified Clinical Global Impression of Change (Modified-CGIC', 'steep concentration-response relationships for plasma levels', 'Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",220.0,0.107878,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shiells', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Bjoern O', 'Initials': 'BO', 'LastName': 'Schelter', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Baddeley', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ganesan', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vuksanovic', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Staff', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bracoud', 'Affiliation': 'Bioclinica, Lyon, France.'}, {'ForeName': 'Damon J', 'Initials': 'DJ', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Riedel', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gauthier', 'Affiliation': ""McGill Centre for Studies in Aging, Alzheimer's Disease Research Unit, and Douglas Mental Health University Institute, Montreal, QC, Canada.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Beijing Institute for Brain Disorders Alzheimer's Disease Centre, Beijing, China.""}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Moebius', 'Affiliation': 'Moebius-Consult, Baar, Switzerland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Hardlund', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kipps', 'Affiliation': 'University Hospital Southampton and University of Southampton, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kook', 'Affiliation': 'Salamandra LLC, Bethesda, MD, USA.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Storey', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Harrington', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191173']
447,32247517,A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households.,"OBJECTIVE


To prospectively examine the bidirectional relationship between parental feeding practices (eg, instrumental feeding, encouragement to eat) and child eating behaviors (eg, food responsiveness, emotional eating) in low-income, ethnically diverse preschool children over a 3-year period.
STUDY DESIGN


Parent/child (age 2-4 years at baseline) pairs (n = 222 non-Hispanics; n = 312 Hispanics) participated in NET-Works (Now Everybody Together for Amazing and Healthful Kids), a randomized controlled trial carried out in community and in-home settings in urban areas of Minnesota. Data were collected at baseline and 12, 24, and 36 months. The present study is a secondary data analysis using cross-lagged models to identify bidirectional associations between parental feeding practices and child eating behaviors.
RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety. Model 1 showed significant bidirectional temporal paths, whereas models 2 and 3 showed significant unidirectional temporal paths from parental feeding practices to child eating behaviors.
CONCLUSIONS


Parental instrumental and emotional feeding practices prospectively influence child food responsiveness and satiety. This study demonstrates causal temporality between parental feeding practices and child eating behaviors. Heath care providers may want to use findings regarding parent feeding practices as part of their anticipatory guidance during well-child visits with parents of preschoolers.",2020,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","['Parent/child (age 2-4\xa0years at baseline) pairs (n\xa0=\xa0222 non-Hispanics; n\xa0=\xa0312 Hispanics) participated in', 'low-income, ethnically diverse preschool children over a 3-year period', 'Parent/Child Dyads from Low-Income and Minority Households', 'parental feeding practices and child eating behaviors', 'community and in-home settings in urban areas of Minnesota']",['NET-Works '],"['parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety', 'child eating behaviors (eg, food responsiveness, emotional eating']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0322418,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","[{'ForeName': 'Jerica M', 'Initials': 'JM', 'LastName': 'Berge', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN. Electronic address: jberge@umn.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Veblen-Mortenson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kunin-Batson', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.001']
448,32282529,Modulation of Countermovement Jump-Derived Markers of Neuromuscular Function With Concurrent vs. Single-Mode Resistance Training.,"Pattison, KJ, Drinkwater, EJ, Bishop, DJ, Stepto, NK, and Fyfe, JJ. Modulation of countermovement jump-derived markers of neuromuscular function with concurrent vs. single-mode resistance training. J Strength Cond Res 34(6): 1497-1502, 2020-This study assessed changes in countermovement jump (CMJ)-derived markers of neuromuscular function with concurrent training vs. resistance training (RT) alone and determined associations between changes in CMJ parameters and other neuromuscular adaptations (e.g., maximal strength gain). Twenty-three recreationally active men performed 8 weeks of RT alone (RT group, n = 8) or combined with either high-intensity interval training cycling (HIIT + RT group, n = 8) or moderate-intensity continuous cycling (MICT + RT group, n = 7). Maximal strength and CMJ performance were assessed before (PRE), after 4 weeks of training (MID), and >72 hours (maximal strength) or >5-7 days (CMJ performance) after (POST) the training intervention. Improvements in CMJ relative peak force from both PRE to MID and PRE to POST were attenuated for both HIIT + RT (effect size [ES]: -0.44; ±90% confidence limit, ±0.51 and ES: -0.72; ±0.61, respectively) and MICT + RT (ES: -0.74; ±0.49 and ES: -1.25; ±0.63, respectively). Compared with RT alone, the change in the flight time to contraction time ratio (FT:CT) was attenuated from PRE to MID for MICT + RT (ES: -0.38; ±0.42) and from PRE to POST for both MICT + RT (ES: -0.60; ±0.55) and HIIT + RT (ES: -0.75; ±0.30). PRE to POST changes in both CMJ relative peak force and flight time:contraction time (F:C) ratio were also associated with relative 1 repetition maximum leg press strength gain (r = 0.26 and 0.19, respectively). These findings highlight the utility of CMJ testing for monitoring interference to improvements in neuromuscular function with concurrent training.",2020,Improvements in CMJ relative peak force from both PRE to MID and PRE to POST were attenuated for both HIIT + RT (effect size [ES]:,['Twenty-three recreationally active men'],"['Countermovement Jump-Derived Markers of Neuromuscular Function With Concurrent vs. Single-Mode Resistance Training', 'RT alone (RT group, n = 8) or combined with either high-intensity interval training cycling (HIIT + RT group, n = 8) or moderate-intensity continuous cycling (MICT + RT', 'concurrent training vs. resistance training (RT) alone', 'J Strength Cond Res XX(X', 'concurrent vs. single-mode resistance training', 'CMJ']","['Pattison, KJ, Drinkwater, EJ, Bishop, DJ, Stepto, NK, and Fyfe, JJ', 'countermovement jump (CMJ)-derived markers of neuromuscular function', 'CMJ parameters and other neuromuscular adaptations (e.g., maximal strength gain', 'flight time to contraction time ratio (FT:CT', 'CMJ relative peak force and flight time:contraction time (F:C) ratio', 'Maximal strength and CMJ performance']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0649610', 'cui_str': '1,2-bis(hexadecyloxy)-3-trimethylaminopropane'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0487834,Improvements in CMJ relative peak force from both PRE to MID and PRE to POST were attenuated for both HIIT + RT (effect size [ES]:,"[{'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Pattison', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Drinkwater', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nigel K', 'Initials': 'NK', 'LastName': 'Stepto', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jackson J', 'Initials': 'JJ', 'LastName': 'Fyfe', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003587']
449,31039580,Quitting starts in the brain: a randomized controlled trial of app-based mindfulness shows decreases in neural responses to smoking cues that predict reductions in smoking.,"Current treatments for smoking yield suboptimal outcomes, partly because of an inability to reduce cue-induced smoking. Mindfulness training (MT) has shown preliminary efficacy for smoking cessation, yet its neurobiological target remains unknown. Our prior work with nonsmokers indicates that MT reduces posterior cingulate cortex (PCC) activity. In individuals who smoke, the PCC, consistently a main hub of the ""default mode network,"" activates in response to smoking cues. In this randomized controlled trial, we tested the effects of app-delivered MT on PCC reactivity to smoking cues and whether individual differences in MT-mediated PCC changes predicted smoking outcomes. Smoking cue-induced PCC reactivity was measured using functional magnetic resonance imaging at baseline and 1 month after receiving smartphone app-based MT (n = 33) vs. an active control (National Cancer Institute's QuitGuide, n = 34). Whether individual differences in treatment-related changes in PCC activity predicted smoking behavior was assessed. The MT group demonstrated a significant correlation between a reduction in PCC reactivity to smoking cues and a decline in cigarette consumption (r = 0.39, p = 0.02). No association was found in the control group (r = 0.08, p = 0.65). No effects of group alone were found in PCC or cigarette reduction. Post hoc analysis revealed this association is sex specific (women, r = 0.49, p = 0.03; men: r = -0.08, p = 0.79). This initial report indicates that MT specifically reduces smoking cue-induced PCC activity in a subject-specific manner, and the reduction in PCC activity predicts a concurrent decline in smoking. These findings link the hypothesized behavioral effects of MT for smoking to neural mechanisms particularly in women. This lays the groundwork for identifying individuals who may benefit from targeted digital therapeutic treatments such as smartphone-based MT, yielding improved clinical outcomes.",2019,No effects of group alone were found in PCC or cigarette reduction.,[],"['app-delivered MT', 'MT', 'smartphone app-based MT', 'Mindfulness training (MT']","['smoking cue-induced PCC activity', 'posterior cingulate cortex (PCC) activity', 'PCC reactivity to smoking cues and a decline in cigarette consumption', 'Smoking cue-induced PCC reactivity']",[],"[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.0279824,No effects of group alone were found in PCC or cigarette reduction.,"[{'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, 02478, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Datko', 'Affiliation': 'Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, 149 Thirteenth St. #2301, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Druker', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Neal', 'Affiliation': 'University of Oklahoma-Tulsa School of Community Medicine, Tulsa, OK, 74135, USA.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ohashi', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, 02478, USA.'}, {'ForeName': 'Hanif', 'Initials': 'H', 'LastName': 'Benoit', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'van Lutterveld', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Judson A', 'Initials': 'JA', 'LastName': 'Brewer', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA. judson_brewer@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0403-y']
450,31060042,Emotion-based brain mechanisms and predictors for SSRI and CBT treatment of anxiety and depression: a randomized trial.,"Mechanisms and predictors for the successful treatment of anxiety and depression have been elusive, limiting the effectiveness of existing treatments and curtailing the development of new interventions. In this study, we evaluated the utility of three widely used neural probes of emotion (experience, regulation, and perception) in their ability to predict symptom improvement and correlate with symptom change following two first-line treatments-selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). Fifty-five treatment-seeking adults with anxiety and/or depression were randomized to 12 weeks of SSRI or CBT treatment (ClinicalTrials.gov identifier: NCT01903447). Functional magnetic resonance imaging (fMRI) was used to examine frontolimbic brain function during emotion experience, regulation, and perception, as probed by the Emotion Regulation Task (ERT; emotion experience and regulation) and emotional face assessment task (EFAT; emotion perception). Brain function was then related to anxiety and depression symptom change. Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms. Both treatments also reduced amygdala activity during emotion experience but brain change did not correlate with symptom change. Lastly, greater pre-treatment insula and amygdala activity during emotion perception predicted greater anxiety and depression symptom improvement. Thus, limbic activity during emotion perception is reduced by both SSRI and CBT treatments, and predicts anxiety and depression symptom improvement. Critically, neural reactivity during emotion perception may be a non-treatment-specific mechanism for symptom improvement.",2019,"Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms.",['Fifty-five treatment-seeking adults with anxiety and/or depression'],"['SSRI or CBT', 'serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT', 'Functional magnetic resonance imaging (fMRI', 'SSRI and CBT']","['Brain function', 'limbic activity during emotion perception', 'anxiety and depression symptom improvement', 'Emotion Regulation Task (ERT; emotion experience and regulation) and emotional face assessment task (EFAT; emotion perception', 'anxiety and depression symptom change', 'anxiety symptoms', 'insula and amygdala activity', 'insula and amygdala activity during emotion perception', 'amygdala activity']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0162758', 'cui_str': '5-HT Uptake Inhibitors'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}]",55.0,0.0131036,"Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms.","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA. sgorka2@uic.edu.'}, {'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Klumpp', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Kennedy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Shankman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Departments of Psychiatry and Family Medicine and Public Health, University of California-San Diego, La Jolla, CA, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0407-7']
451,29581079,Thiazolidinediones and Risk of Atrial Fibrillation Among Patients with Diabetes and Coronary Disease.,"BACKGROUND


We sought to determine whether insulin-sensitizing therapy (thiazolidinediones or metformin) decreased the risk of developing atrial fibrillation compared with insulin-providing therapy (insulin, sulfonylurea, or a meglitinide). Thiazolidinediones are insulin sensitizers that also decrease the inflammatory response. Because inflammation is a risk factor for atrial fibrillation, we hypothesized that treating diabetes with thiazolidinediones might decrease the risk of developing atrial fibrillation.
METHODS


The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial enrolled patients with type 2 diabetes and documented coronary artery disease. All patients were randomized to insulin-sensitizing therapy or insulin-providing therapy.
RESULTS


A total of 2319 patients entered the study, with 1160 assigned to the insulin-sensitization strategy and 1159 assigned to the insulin-provision strategy. Over a median follow-up of 4.2 years, 90 patients (3.9%) developed new-onset atrial fibrillation. In the intention-to-treat analysis, the incidence of atrial fibrillation was 8.7 per 1000 person-years in patients assigned to insulin sensitization compared with 9.5 in patients assigned to insulin provision with a hazard ratio (HR) of 0.91 (95% confidence interval [CI], 0.60-1.38, P = .66). In a time-varying exposure analysis, the incidence rate per 1000 person-years was 7.2 while exposed to thiazolidinediones and 9.7 while not exposed to thiazolidinediones with an adjusted HR of 0.80 (95% CI, 0.33-1.94, P = .62). In a subset of patients matched on propensity to receive a thiazolidinediones, the HR was 0.75 (95% CI, 0.43-1.30, P = .30).
CONCLUSIONS


We did not find a significant reduction of atrial fibrillation incidence with use of thiazolidinediones.",2018,"In the intention-to-treat analysis, the incidence of atrial fibrillation was 8.7 per 1000 person-years in patients assigned to insulin sensitization compared with 9.5 in patients assigned to insulin provision with a hazard ratio (HR) of 0.91","['Patients with Diabetes and Coronary Disease', '2319 patients entered the study, with 1160 assigned to the insulin-sensitization strategy and 1159 assigned to the insulin-provision strategy', 'Investigation 2 Diabetes (BARI 2D) trial enrolled patients with type 2 diabetes and documented coronary artery disease']","['insulin-providing therapy (insulin, sulfonylurea', 'thiazolidinediones', 'Bypass Angioplasty Revascularization', 'Thiazolidinediones', 'insulin-sensitizing therapy (thiazolidinediones or metformin', 'insulin-sensitizing therapy or insulin-providing therapy']","['risk of developing atrial fibrillation', 'atrial fibrillation incidence', 'incidence of atrial fibrillation', 'inflammatory response', 'Thiazolidinediones and Risk of Atrial Fibrillation', 'new-onset atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",2319.0,0.113227,"In the intention-to-treat analysis, the incidence of atrial fibrillation was 8.7 per 1000 person-years in patients assigned to insulin sensitization compared with 9.5 in patients assigned to insulin provision with a hazard ratio (HR) of 0.91","[{'ForeName': 'Jannik Langtved', 'Initials': 'JL', 'LastName': 'Pallisgaard', 'Affiliation': 'Copenhagen University Hospital Gentofte and Herlev, Hellerup, Copenhagen, Denmark; Copenhagen University, Faculty of Health and Medical Sciences, Copenhagen, Denmark. Electronic address: jannikjannik@gmail.com.'}, {'ForeName': 'Maria Mori', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'St Louis University, St Louis, Mo.'}, {'ForeName': 'Derek B', 'Initials': 'DB', 'LastName': 'Boothroyd', 'Affiliation': 'Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Perez', 'Affiliation': 'Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hlatky', 'Affiliation': 'Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of medicine,['10.1016/j.amjmed.2018.02.026']
452,32279184,Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial.,"OBJECTIVE


Bariatric surgery is not a risk-free procedure and requires lifelong patient compliance in the postoperative period. Although the risks involved in bariatric surgery and the importance of lifelong follow-ups in the postoperative period are explained to patients in detail through verbal and written informed consent, the strong desire for weight loss can sometimes cause patients and their families to be ignorant of the mentioned issues preoperatively. The objective of this study is to evaluate the effectiveness of preoperative informational videos at improving the comprehension of informed consent content in bariatric surgery candidates.
MATERIALS AND METHODS


A total of 74 bariatric surgery candidates were randomized into two groups. The first group was given a usual verbal-written informed consent. The second group got an additional informing video presentation informed consent, in addition to the usual verbal-written informed consent. Then, both groups got a questionnaire evaluating their knowledge of bariatric surgery informed consent. The correct response scores and their relationship with patient demographics were analyzed.
RESULTS


Both groups had similar demographic features. Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001). Subgroup analysis showed that health care workers (12.5 ± 1.9 versus 10.3 ± 2.2, p = 0.005) and university graduates (11.6 ± 2.4 versus 10.1 ± 2.1, p = 0.03) got better results in the questionnaire. In multivariate analysis, video-assisted informing was found to be the only independent variable for high questionnaire scores (p = 0.0001).
CONCLUSIONS


This study showed that video-assisted informed consent improves patients' comprehension prior to bariatric surgery. We recommend routine preoperative video-assisted informing for bariatric surgery candidates in addition to usual verbal-written informed consent.",2020,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","['74 bariatric surgery candidates', ""patients' comprehension prior to bariatric surgery""]","['usual verbal-written informed consent', 'additional informing video presentation informed consent, in addition to the usual verbal-written informed consent', 'video-assisted informed consent', 'preoperative informational videos']","['health care workers', 'high questionnaire scores']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.0360758,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","[{'ForeName': 'Kutay', 'Initials': 'K', 'LastName': 'Saglam', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey. saglamk@gmail.com.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Kayaalp', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Aktas', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Sumer', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04552-x']
453,32279451,Effects of liraglutide and empagliflozin added to insulin therapy in patients with type 2 diabetes: A randomized controlled study.,"AIMS/INTRODUCTION


Liraglutide and empagliflozin suppress cardiovascular events. However, reports on their long-term combined use with insulin therapy or direct comparisons of these drugs are limited.
MATERIALS AND METHODS


This open-label, parallel-group, randomized controlled trial compared the effects of liraglutide and empagliflozin combined with insulin therapy in type 2 diabetes patients. Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0-9.5% were enrolled. Participants received 0.9 mg/day liraglutide or 10 mg/day empagliflozin for 24 weeks. The primary end-point was the change in glycated hemoglobin levels from week 0 to 24. Body composition was assessed by dual-energy X-ray absorptiometry.
RESULTS


A total of 64 insulin-treated patients were randomized to receive liraglutide or empagliflozin. We analyzed 61 patients (30 liraglutide and 31 empagliflozin) who could be followed up. Liraglutide induced greater changes in glycated hemoglobin and glycated albumin than empagliflozin (glycated hemoglobin -1.24 ± 0.15% vs -0.35 ± 0.11%, P < 0.0001; glycated albumin -4.4 ± 0.6% vs -2.4 ± 0.5%, P < 0.01). Bodyweight (-1.3 ± 0.4 kg vs -1.5 ± 0.3 kg, P = 0.69) or body fat mass/lean tissue mass; urinary albumin excretion (median -5.3 mg/g-creatinine [interquartile range -60.6, 9.9 mg/g-creatinine] vs -12.9 mg/g-creatinine [interquartile range -70.8, -2.0 mg/g-creatinine], P = 0.23); and frequency of hypoglycemia did not differ significantly between the groups over a period of 24 weeks. There were no cases of study discontinuation owing to adverse effects.
CONCLUSIONS


Liraglutide addition to ongoing insulin therapy more effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.",2020,Liraglutide addition to ongoing insulin therapy effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.,"['type 2 diabetes patients', 'Sixty-four insulin-treated patients', 'Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0-9.5% were enrolled', '61 patients (30', 'patients with inadequately controlled type 2 diabetes', 'patients with type 2 diabetes']","['empagliflozin', 'liraglutide and empagliflozin combined with insulin therapy', 'insulin therapy', 'Liraglutide and empagliflozin', 'liraglutide and empagliflozin', 'liraglutide and 31 empagliflozin', 'Liraglutide', 'liraglutide or empagliflozin', 'liraglutide or 10 mg/day empagliflozin']","['Body weight', 'change in glycated hemoglobin levels', 'glycated hemoglobin and glycated albumin', 'frequency of hypoglycemia', 'body fat mass/lean tissue mass; urinary albumin excretion [(median, IQR', 'glycated hemoglobin and glycated albumin levels', 'Body composition']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0132254', 'cui_str': 'drebrin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",64.0,0.0764494,Liraglutide addition to ongoing insulin therapy effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.,"[{'ForeName': 'Hirotatsu', 'Initials': 'H', 'LastName': 'Nakaguchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Kyohara', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Konishi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oiwa', 'Affiliation': 'Japan Community Health Care Organization, Yokohama Chuo Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13270']
454,30761720,Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes.,"AIM


To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add-on to sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy.
MATERIALS AND METHODS


In this 26-week, phase IIIb, open-label, parallel-group, treat-to-target trial, conducted at 74 sites in 11 countries, insulin-naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53-97 mmol/mol (7.0-11.0%), body mass index 20-40 kg/m 2  and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once-daily IDegLira or IGlar U100, both as add-on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26.
RESULTS


A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%-points) with IDegLira and 18 mmol/mol (1.7%-points) with IGlar U100; confirming non-inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change -3.90 mmol/mol; 95% confidence interval [CI] -5.45; -2.35 (-0.36%-points; 95% CI -0.50, -0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference -1.92 kg; 95% CI -2.64, -1.19); severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference -15.37 U; 95% CI -19.60, -11.13). The overall treatment-emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates.
CONCLUSIONS


The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population.",2019,"Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference -1.92 kg; 95% CI -2.64, -1.19); severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference -15.37 U; 95% CI -19.60, -11.13).","['210 participants', 'people with uncontrolled type 2 diabetes', 'people with uncontrolled T2D', '11 countries, insulin-naïve people aged ≥18\u2009years with glycated haemoglobin (HbA1c) 53-97 mmol/mol (7.0-11.0%), body mass index 20-40\u2009kg/m 2  and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs']","['IDegLira', 'insulin degludec/liraglutide (IDegLira) versus insulin glargine', 'insulin degludec/liraglutide versus insulin glargine', 'inhibitor therapy']","['lipase and nausea rates', 'superiority of IDegLira', 'change in HbA1c', 'severe or blood-glucose-confirmed symptomatic hypoglycaemia', 'Mean HbA1c reductions', 'total daily insulin dose', 'body weight']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",210.0,0.398058,"Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference -1.92 kg; 95% CI -2.64, -1.19); severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference -15.37 U; 95% CI -19.60, -11.13).","[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, California.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'NorthShore University HealthSystem, Skokie, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Albany Medical Centre, Albany, New York.'}, {'ForeName': 'Cristobal Morales', 'Initials': 'CM', 'LastName': 'Portillo', 'Affiliation': 'Hospital Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Sahay', 'Affiliation': 'Osmania Medical College, Hyderabad, India.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Halladin', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Eggert', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Begtrup', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Western University, London, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13666']
455,32027931,Three behavior change theory-informed randomized studies within a trial to improve response rates to trial postal questionnaires.,"OBJECTIVES


Our aim was to design and evaluate a novel behavior change approach to increase response rates to an annual postal questionnaire in three randomized studies within a trial (SWAT) and replicate the most promising SWAT.
STUDY DESIGN AND SETTING


SWAT1 tested a trial logo sticker on questionnaire envelopes vs. no sticker; SWAT2 tested a theoretically informed letter sent with the questionnaire vs. a standard letter; SWAT3 tested a theoretically informed newsletter sent before the questionnaire vs. no newsletter. The SWATs were conducted within a large dental trial (N = 1,877 adults), and SWAT2 replicated in a different trial in a similar setting (N = 2,372).
RESULTS


SWAT1 improved response rates by 1.4%, 95% confidence interval (CI) (-7.2%, 10.0%). SWAT2 improved response rates by 7.0%, 95% CI (1.7%, 12.3%). SWAT3 improved response rates by 0.8%, 95% CI (-5.1%, 6.7%). Replication of SWAT2 as the most promising SWAT showed improvement in response rates of 1.0%, 95% CI (-3.2%, 5.3%). Pooled results from SWAT2 showed an overall improvement in response rates of 3.4%, 95% CI (0.1%, 6.7%).
CONCLUSION


A theory-based behavioral approach to design interventions to improve trial response rates showed small but meaningful improvements. The approach presented here can be easily implemented and adapted to address other identified barriers to trial retention.",2020,"RESULTS


SWAT1 improved response rates by 1.4%, 95% confidence interval (CI) (-7.2%, 10.0%).",['SWAT1 tested a trial logo sticker on questionnaire envelopes vs no sticker; SWAT2 tested a theoretically informed letter sent with the questionnaire versus a standard letter; SWAT3 tested a theoretically informed newsletter sent prior to the questionnaire versus no newsletter'],[],['response rates'],"[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]",[],[],1877.0,0.125624,"RESULTS


SWAT1 improved response rates by 1.4%, 95% confidence interval (CI) (-7.2%, 10.0%).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK. Electronic address: beatriz.goulao@abdn.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Duncan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Floate', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.01.018']
456,32277531,Five-year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non-small-cell lung cancer.,"Combination antiprogrammed death 1/programmed death-ligand 1 Ab and platinum-based chemotherapy is standard first-line treatment for advanced non-small-cell lung cancer without targetable oncogene alterations. We describe the long-term safety and efficacy data from a previously reported phase Ib study of nivolumab and chemotherapy. Japanese patients with non-small-cell lung cancer were assigned to a treatment arm based on histology and treatment history. Nivolumab (10 mg/kg, i.v.) and chemotherapy (4 arms) were given every 3 weeks: arm A, 4 cycles of cisplatin and gemcitabine (first-line); arm B, 4 cycles of cisplatin and pemetrexed followed by pemetrexed maintenance therapy (first-line); arm C, 4-6 cycles of carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); and arm D, docetaxel (second- or third-line). Study treatments were continued every 3 weeks as maintenance therapy until disease progression. Minimum follow-up period was 57.9 months. Median progression-free survival (median [range, plus sign indicates censored data]) was 6.3 (0.7+-47.8), 11.8 (1.4-65.1+), 40.7 (5.3-60.8+), and 3.2 (1.9-10.9) months, and 5-year progression-free survival was observed in 0/6, 1/6, 1/6, and 0/6 patients in arms A, B, C, and D, respectively. Median overall survival was 13.2 (11.0-55.4), 28.5 (14.6-66.2+), not reached (24.2-67.4+), and 12.5 (9.8-16.9) months; the number of patients surviving 5 years were 0/6, 1/6, 4/6, and 0/6 in arms A, B, C, and D, respectively. No unexpected severe adverse events or treatment-related deaths occurred. Nivolumab and platinum-based chemotherapy combinations showed long-term tolerability. A moderate proportion of patients in arm C showed 5-year progression-free and overall survival.",2020,No unexpected severe adverse events or treatment-related deaths occurred.,"['advanced non-small-cell lung cancer', 'Japanese patients with non-small-cell lung cancer']","['Nivolumab', 'Combination anti-programmed death 1/programmed death-ligand 1 antibody and platinum-based chemotherapy', 'nivolumab and chemotherapy', 'cisplatin and pemetrexed followed by pemetrexed maintenance therapy', 'chemotherapy', 'carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); arm D, docetaxel (second- or third-line', 'Nivolumab and platinum-based chemotherapy combinations', 'cisplatin and gemcitabine']","['5-year progression-free and overall survival', 'severe adverse events', 'Median overall survival', '5-year progression-free survival', 'long-term tolerability', 'Median progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.065678,No unexpected severe adverse events or treatment-related deaths occurred.,"[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Oncology Clinical Development Planning 1, Ono Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Cancer science,['10.1111/cas.14410']
457,32277977,The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults.,"BACKGROUND


Physical muscle function and brain hippocampus size declines with age, accelerating after the age of 60. Strength training over a few months improves physical function, but less is known about how long-term strength training affects physical function and hippocampus volume. Therefore, we aimed to investigate the effect of 1-year strength training of two different intensities upon muscle mass, function, and hippocampus volume in retirement-age individuals.
METHODS


In this multidisciplinary randomized controlled trial (clinicaltrials.gov: NCT02123641), participants were allocated to either a) supervised, heavy resistance training (HRT, n = 149, 3/wk), b) moderate intensity resistance training (MIT, n = 154, 3/wk) or c) non-exercise activities (CON, n = 148). 451 participants were randomized (62-70 yrs., women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n = 143, 144 and 132; HRT, MIT and CON). Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed.
FINDINGS


Of the participants (HRT + MIT), 83% completed training at least 2/week. Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only. Further, chair-stand performance improved in all groups, whereas hippocampus volume decreased in all groups over time with no influence of strength training.
INTERPRETATION


Together, the results indicate that leg extensor power did not respond to long-term supervised strength training, but this type of training in a mixed group of healthy and chronically diseased elderly individuals can be implemented with good compliance and induces consistent changes in physiological parameters of muscle strength, muscle mass and abdominal fat.",2020,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","['retirement-age individuals', ' women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n\u202f=\u202f143, 144 and 132; HRT, MIT and CON', '451 participants were randomized (62-70\u202fyrs', 'healthy and chronically diseased older adults']","['heavy resistance training (HRT, n\u202f=\u202f149, 3/wk), b) moderate intensity resistance training (MIT, n\u202f=\u202f154, 3/wk) or c) non-exercise activities (CON, n\u202f=\u202f148', 'prolonged strength training', 'Strength training']","['Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed', 'hippocampus volume', 'increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36', 'Leg extensor power', 'physical function', 'chair-stand performance', 'isometric knee extensor strength']","[{'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",451.0,0.032446,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Garde', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Nina Linde', 'Initials': 'NL', 'LastName': 'Reislev', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kasper Winther', 'Initials': 'KW', 'LastName': 'Andersen', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Technology, University College Copenhagen, Sigurdsgade 26, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kenneth Hudlebusch', 'Initials': 'KH', 'LastName': 'Mertz', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Monika Lucia', 'Initials': 'ML', 'LastName': 'Bayer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.110939']
458,31405365,Effect of deep tissue laser therapy treatment on peripheral neuropathic pain in older adults with type 2 diabetes: a pilot randomized clinical trial.,"BACKGROUND


This study assessed the safety and efficacy of deep tissue laser therapy on the management of pain, functionality, systemic inflammation, and overall quality of life of older adults with painful diabetic peripheral neuropathy.
METHODS


The effects of deep tissue laser therapy (DTLT) were assessed in a randomized, double-masked, sham-controlled, interventional trial. Forty participants were randomized (1:1) to receive either DTLT or sham laser therapy (SLT). In addition to the standard-of-care treatment, participants received either DTLT or SLT twice weekly for 4 weeks and then once weekly for 8 weeks (a 12-week intervention period). The two treatments were identical, except that laser emission was disabled during SLT. Assessments for pain, functionality, serum levels of inflammatory biomarkers, and quality of life (QOL) were performed at baseline and after the 12-week intervention period. The results from the two treatments were compared using ANOVA in a pre-test-post-test design.
RESULTS


All participants randomized to the DTLT group and 85% (17 of 20) of participants randomized to the SLT group completed the trial. No significant differences in baseline characteristics between the groups were observed. After the 12-week intervention period, pain levels significantly decreased in both groups and were significantly lower in the DTLT group than in the SLT group. The Timed Up and Go test times (assessing functionality) were significantly improved in both groups and were 16% shorter in the DTLT group than in the SLT group. Serum levels of IL-6 decreased significantly in both groups. Additionally, serum levels of MCP-1 decreased significantly in the DTLT group but not in the SLT group. Patients' quality of life improved significantly in the DTLT group but not in the SLT group.
CONCLUSIONS


Deep tissue laser therapy significantly reduced pain and improved the quality of life of older patients with painful diabetic peripheral neuropathy.
TRIAL REGISTRATION


Clinical Trial Registry-India CTRI/2017/06/008739 . [Registered on: 02/06/2017]. The trial was registered retrospectively.",2019,The Timed Up and Go test times (assessing functionality) were significantly improved in both groups and were 16% shorter in the DTLT group than in the SLT group.,"['older patients with painful diabetic peripheral neuropathy', 'older adults with painful diabetic peripheral neuropathy', 'older adults with type 2 diabetes', 'Forty participants']","['DTLT or sham laser therapy (SLT', 'DTLT', 'deep tissue laser therapy', 'SLT', 'Deep tissue laser therapy', 'deep tissue laser therapy (DTLT', 'DTLT or SLT', 'deep tissue laser therapy treatment']","['Timed Up and Go test times (assessing functionality', 'pain', 'pain levels', 'pain, functionality, serum levels of inflammatory biomarkers, and quality of life (QOL', 'Serum levels of IL-6', 'quality of life', 'peripheral neuropathic pain', 'pain, functionality, systemic inflammation, and overall quality of life', 'serum levels of MCP-1', 'safety and efficacy']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0034380'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0897887,The Timed Up and Go test times (assessing functionality) were significantly improved in both groups and were 16% shorter in the DTLT group than in the SLT group.,"[{'ForeName': 'Prasun', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India. drprasun.geriatrics@gmail.com.'}, {'ForeName': 'Achal K', 'Initials': 'AK', 'LastName': 'Srivastava', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa A', 'Initials': 'DA', 'LastName': 'Kumar', 'Affiliation': 'Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Chakrawarty', 'Affiliation': 'Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Maroof A', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Akash K', 'Initials': 'AK', 'LastName': 'Ambashtha', 'Affiliation': 'Health World Hospital, Durgapur, West Bengal, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'De Taboada', 'Affiliation': 'LiteCure LLC, Carlsbad, CA, USA.'}, {'ForeName': 'Aparajit B', 'Initials': 'AB', 'LastName': 'Dey', 'Affiliation': 'Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India.'}]",BMC geriatrics,['10.1186/s12877-019-1237-5']
459,32275467,"Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial.","PURPOSE


Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) includes a taxane and an anthracycline. Concomitant capecitabine may be beneficial, but robust data to support this are lacking. The efficacy and safety of the addition of capecitabine into the TNBC adjuvant treatment regimen was evaluated.
PATIENTS AND METHODS


This randomized, open-label, phase III trial was conducted in China. Eligible female patients with early TNBC after definitive surgery were randomly assigned (1:1) to either capecitabine (3 cycles of capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide). Randomization was centralized without stratification. The primary end point was disease-free survival (DFS).
RESULTS


Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585 were randomly assigned to treatment (control, 288; capecitabine, 297). Median follow-up was 67 months. The 5-year DFS rate was higher for capecitabine than for control treatment (86.3%  v  80.4%; hazard ratio, 0.66; 95% CI, 0.44 to 0.99;  P  = .044). Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%). Overall, 39.1% of patients had capecitabine dose reductions, and 8.4% reported grade ≥ 3 hand-foot syndrome. The most common grade ≥ 3 hematologic toxicities were neutropenia (capecitabine, 136 [45.8%]; control, 118 [41.0%]) and febrile neutropenia (capecitabine, 50 [16.8%]; control, 46 [16.0%]). Safety data were similar to the known capecitabine safety profile and generally comparable between arms.
CONCLUSION


Capecitabine when added to 3 cycles of docetaxel followed by 3 cycles of a 3-drug anthracycline combination containing capecitabine instead of fluorouracil significantly improved DFS in TNBC without new safety concerns.",2020,"Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%).","['Triple-Negative Breast Cancer', 'Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585', 'Eligible female patients with early TNBC after definitive surgery', 'triple-negative breast cancer (TNBC']","['taxane and an anthracycline', 'docetaxel', 'CBCSG010', 'fluorouracil', 'adjuvant chemotherapy', 'capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide', 'Capecitabine', 'capecitabine', 'Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin']","['disease-free survival (DFS', 'overall survival rates', 'febrile neutropenia', 'DFS', 'hematologic toxicities', '5-year DFS rate', 'efficacy and safety']","[{'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",636.0,0.0969312,"Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%).","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Keda', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': ""Department of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Changqin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Jilin Cancer Hospital and Institute, Changchun, Jilin, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Breast Surgery, Southwest Hospital, Chongqing, Chongqing, People's Republic of China.""}, {'ForeName': 'Suisheng', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Breast Surgery, Gansu Cancer Hospital, Lanzhou, Gansu, People's Republic of China.""}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': ""Department of Breast Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Sheng', 'Affiliation': ""Department of Breast Surgery, Changhai Hospital of Shanghai, Shanghai, People's Republic of China.""}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Cancer Hospital of Shantou Medical College, Shantou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Breast Surgery, The Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, The International Peace Maternity and Child Health Hospital of China Welfare Institute, Shanghai, People's Republic of China.""}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': ""Department of Breast Surgery, Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, People's Republic of China.""}, {'ForeName': 'Xijing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Medical College, The Second Affiliated Hospital of Xi'An Jiaotong University, Xi'an, Shanxi, People's Republic of China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': ""Department of Breast Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, People's Republic of China.""}, {'ForeName': 'Xinzheng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Breast Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, People's Republic of China.""}, {'ForeName': 'Shiyou', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Eastern Hospital of Suzhou Municipal Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Pengxi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': ""Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""Department of Breast Surgery, Jiangsu Cancer Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ouchen', 'Initials': 'O', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, The First Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Breast Surgery, The First Hospital of Jilin University, Changchun, Jilin, People's Republic of China.""}, {'ForeName': 'Guoqin', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': ""Department of General Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The General Hospital of the People's Liberation Army, Beijing, People's Republic of China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Jiangsu Province Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Breast Surgery, The First Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Nanyan', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': ""Department of Breast Surgery, The Second Affiliated Hospital of Zhongshan University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Binlin', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': ""Department of Breast Surgery, Xinjiang Cancer Hospital, Wulumuqi, Xinjiang, People's Republic of China.""}, {'ForeName': 'Pingqing', 'Initials': 'P', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Shanghai Sixth People's Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhuang', 'Affiliation': ""Department of Breast Surgery, Shanghai First Maternity and Infant Hospital Corporation, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Shanghai General Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Department of Breast Surgery, Peking Union Medical College Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Continuing Education and Technology Services Department, Chinese Anti-Cancer Association, Tianjin, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': ""Department of Cancer Prevention, Fudan University Shanghai Cancer Center, and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02474']
460,32271672,Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer.,"PURPOSE


Platinum-based chemotherapy for first-line treatment of metastatic urothelial cancer is typically administered for a fixed duration followed by observation until progression. ""Switch maintenance"" therapy with PD-1 blockade at the time of chemotherapy cessation may be attractive for mechanistic and pragmatic reasons.
PATIENTS AND METHODS


Patients with metastatic urothelial cancer achieving at least stable disease on first-line platinum-based chemotherapy were enrolled. Patients were randomly assigned double-blind 1:1 to switch maintenance pembrolizumab 200 mg intravenously once every 3 weeks versus placebo for up to 24 months. Patients with disease progression on placebo could cross over to pembrolizumab. The primary objective was to determine the progression-free survival. Secondary objectives included determining overall survival as well as treatment outcomes according to PD-L1 combined positive score (CPS).
RESULTS


Between December 2015 and November 2018, 108 patients were randomly assigned to pembrolizumab (n = 55) or placebo (n = 53). The objective response rate was 23% with pembrolizumab and 10% with placebo. Treatment-emergent grade 3-4 adverse events occurred in 59% receiving pembrolizumab and 38% of patients receiving placebo. Progression-free survival was significantly longer with maintenance pembrolizumab versus placebo (5.4 months [95% CI, 3.1 to 7.3 months]  v  3.0 months [95% CI; 2.7 to 5.5 months]; hazard ratio, 0.65; log-rank  P  = .04; maximum efficiency robust test  P  = .039). Median overall survival was 22 months (95% CI, 12.9 months to not reached) with pembrolizumab and 18.7 months (95% CI, 11.4 months to not reached) with placebo. There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
CONCLUSION


Switch maintenance pembrolizumab leads to additional objective responses in patients achieving at least stable disease with first-line platinum-based chemotherapy and prolongs progression-free survival in patients with metastatic urothelial cancer.",2020,"There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
","['Patients with metastatic urothelial cancer achieving at least stable disease on first-line platinum-based chemotherapy were enrolled', 'metastatic urothelial cancer', 'Patients with disease progression on', 'Patients With Metastatic Urothelial Cancer', 'patients with metastatic urothelial cancer', '108 patients', 'Between December 2015 and November 2018']","['Platinum-based chemotherapy', 'placebo', 'First-Line Chemotherapy', 'Maintenance Pembrolizumab Versus Placebo', 'maintenance pembrolizumab 200 mg intravenously once every 3 weeks versus placebo', 'pembrolizumab']","['overall survival as well as treatment outcomes according to PD-L1 combined positive score (CPS', 'objective response rate', 'adverse events', 'progression-free survival or overall survival', 'Median overall survival', 'Progression-free survival', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",108.0,0.535753,"There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Division of Hematology and Medical Oncology, The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mortazavi', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, and the Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Milowsky', 'Affiliation': 'Division of Hematology and Medical Oncology, University of North Carolina School of Medicine, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Division of Oncology, University of Utah, Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fleming', 'Affiliation': 'US Oncology Research, Virginia Oncology Associates, Hampton, VA.'}, {'ForeName': 'Long H', 'Initials': 'LH', 'LastName': 'Dang', 'Affiliation': 'Ochsner Medical Center, Baton Rouge, LA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Walling', 'Affiliation': 'Community Regional Cancer Care, Community Health Network, Indianapolis, IN.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Alter', 'Affiliation': 'John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Kassar', 'Affiliation': 'Community Hospital, Munster, IN.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""University of Arizona Cancer Center at Dignity Health St Joseph's Hospital and Medical Center, Phoenix, AZ.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Davis', 'Affiliation': 'Division of Hematology and Medical Oncology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Picus', 'Affiliation': 'Division of Oncology, Department of Medicine, and Siteman Cancer Center, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Philips', 'Affiliation': 'Division of Hematology and Medical Oncology, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Division of Oncology, University of Southern California Norris Comprehensive Cancer Center, Keck School of Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'G Kenneth', 'Initials': 'GK', 'LastName': 'Haines', 'Affiliation': 'Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Hahn', 'Affiliation': 'Department of Oncology and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Menggang', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03091']
461,31664960,A group randomized control trial to test the efficacy of the Road to Mental Readiness (R2MR) program among Canadian military recruits.,"BACKGROUND


Despite increased interest in workplace mental health interventions, the evidence for beneficial effects is mixed. Furthermore, many existing studies lack methodological rigor. We report results from a group randomized control trial to test the efficacy of a vastly popular intervention in Canada, the Road to Mental Readiness (R2MR) program, which has been widely disseminated in military, first responder, and civilian settings.
METHODS


The trial took place among Canadian Armed Forces military recruits completing their basic military qualification (BMQ) training, and randomized 65 platoons (N = 2831) into either (a) an Intervention (R2MR at week 2 of BMQ), or (b) a delayed Intervention Control (R2MR at week 9 of BMQ) condition. The principal investigator, participants, and data collection staff were blinded to platoon condition. Individual-level psychological functioning, resilience, mental health service use attitudes, intentions, and behaviours, and additional covariates were assessed with questionnaires around week 2 (a day or two before Intervention platoons received R2MR), at week 5, and at week 9 (a day or two before the Control platoons received R2MR). Military performance outcomes were obtained from administrative databases.
RESULTS


The full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time. Analyses among two subsamples (Group 1: Intervention platoons with a Fidelity Check and their Controls, and Group 2: Intervention platoons without Fidelity Check and their Controls) indicated that for some outcomes (attitudes and help-seeking), under high fidelity conditions, the beneficial effects of R2MR were increased and better sustained; Conversely, under poor fidelity conditions, decreased beneficial effects or even iatrogenic effects were observed. Analyses across three training divisions indicated the larger organizational climate further influences efficacy.
CONCLUSIONS


Our findings paint a very complex picture in which it is made evident that sensible, evidence-informed workplace mental health interventions such as R2MR may work under high fidelity conditions, but may yield no discernable benefit or even inadvertent iatrogenic effects if implemented poorly or without sufficient consideration to the larger organizational context.
TRIAL REGISTRATION


ISRCTN 52557050 Registered 13 October 2016.",2019,"The full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time.",['Canadian military recruits'],"['vastly popular intervention', 'Road to Mental Readiness (R2MR) program', '52557050']","['outcomes (psychological functioning, resilience, and military performance', 'see benefits (mental health service use attitudes, intentions, behaviours', 'beneficial effects or even iatrogenic effects', 'Individual-level psychological functioning, resilience, mental health service use attitudes, intentions, and behaviours, and additional covariates']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439669', 'cui_str': 'Iatrogenic (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0741313,"The full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time.","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Fikretoglu', 'Affiliation': 'Defence Research and Development Canada - Toronto Research Centre, 1133 Sheppard Ave West, Toronto, Ontario, M3K 2C9, Canada. Deniz.Fikretoglu@drdc-rddc.gc.ca.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Nazarov', 'Affiliation': ""The MacDonald Franklin OSI Research Centre, Parkwood Institute, St. Joseph's Health Care London, London, Ontario, Canada.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Blackler', 'Affiliation': 'Defence Research and Development Canada - Toronto Research Centre, 1133 Sheppard Ave West, Toronto, Ontario, M3K 2C9, Canada.'}]",BMC psychiatry,['10.1186/s12888-019-2287-0']
462,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


The present study aimed to compare the pharmacokinetic/pharmacodynamic (PK/PD) parameters of imipenem administered by two-step (50% delivered in a 30-min bolus, 50% for the following 90 min) or extended (administered continuously for 2 h) infusion.
METHODS


Patients with sepsis and septic shock were prospectively enrolled and randomized into four groups. Subjects in the two-step or extended groups were given two doses of imipenem (0.5 g q6h and 1.0 g q8h). The plasma imipenem concentrations were measured at given time points after the fifth dose. The PK/PD target was defined as the achievement of a fractional time above the minimal inhibitory concentration (MIC) of > 40%.
RESULTS


Thirty-five patients were eventually enrolled. No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05). All four groups achieved 40% T > MIC when MIC was 0.5-4.0 μg/ml, but only regimens with a higher dose (1.0 g q8h) achieved target when MIC was 8 μg/ml.
CONCLUSION


The two-step and extended regimens of imipenem are comparable to the PK/PD target in the treatment of sepsis and septic shock. A higher dose (1.0 g q8h) should be considered for target achievement at an MIC of > 8 μg/ml.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
463,32259016,Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance).,"Background


Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear.
Methods


This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuximab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided.
Results


Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0 years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44;  P  <   .001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30;  P  =   .02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
Conclusions


Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.",2020,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","['Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network', 'Patients with diabetes tolerate first-line treatment with', 'patients with advanced or metastatic colorectal cancer (CRC', 'advanced or metastatic CRC', 'Patients', '2326 patients, 378 (16.3%) had diabetes', 'patients with advanced or metastatic CRC']","['bevacizumab and/or cetuximab', 'chemotherapy and monoclonal antibodies']","['physician-documented diabetes', 'overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events', 'median time to a PFS event', 'median time to an OS event', 'grade 3 hypertension', 'adverse events, including neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",2326.0,0.0321453,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Blase N', 'Initials': 'BN', 'LastName': 'Polite', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}]",JNCI cancer spectrum,['10.1093/jncics/pkz078']
464,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance


Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective


To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants


Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures


All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures


The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results


Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance


Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
465,32269052,"Impact of Neoadjuvant Durvalumab with or without Tremelimumab on CD8 +  Tumor Lymphocyte Density, Safety, and Efficacy in Patients with Oropharynx Cancer: CIAO Trial Results.","PURPOSE


In oropharyngeal squamous cell carcinoma (OPC), high CD8 +  tumor-infiltrating lymphocyte (CD8 + TIL) density confers improved prognosis. We compared neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab + tremelimumab (CTLA-4 inhibitor) in terms of impact on CD8 + TIL density, safety, and efficacy in patients with OPC.
PATIENTS AND METHODS


Patients with newly diagnosed stage II-IVA OPC or locoregionally recurrent OPC amenable to resection were included. Patients were randomized to two cycles of durvalumab or durvalumab + tremelimumab before surgery. The primary endpoint was change between baseline and resection specimen in CD8 + TIL density between arms. Secondary endpoints included safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes.
RESULTS


Of 28 eligible patients (14/arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive. The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P  = 0.97; 95% CI: -1.07-2.28). In each group, 6 patients (43%, 95% CI: 17.66-71.14) had a response. Eight patients (29%) had a MPR at the primary tumor and/or nodal metastases. Neither baseline CD8 + TIL density nor PD-L1 expression level correlated with overall response, but a trend toward greater CD8 + TIL change in patients with a MPR was seen ( P  = 0.059; 95% CI: -0.33-3.46). Four patients (14%) had grade ≥3 adverse events. At median follow-up time of 15.79 months, all patients were alive, and one had an additional recurrence.
CONCLUSIONS


Durvalumab + tremelimumab did not increase CD8 + TIL density more than durvalumab alone did. The observed safety and activity support further investigation of neoadjuvant checkpoint inhibitor for OPC.",2020,"The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P =.97, 95%CI:(-1.07,2.28)).","['Patients with newly diagnosed stage II-IVA OPC or locoregionally-recurrent OPC amenable to resection were included', 'OPC patients', 'patients with oropharynx cancer', '28 eligible patients (14 per arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive', 'oropharyngeal squamous cell carcinoma (OPC']","['durvalumab or durvalumab plus tremelimumab', 'neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab plus tremelimumab (CTLA-4 inhibitor', 'neoadjuvant durvalumab with or without tremelimumab']","['change between baseline and resection specimen in CD8 + TIL density', 'CD8+ tumor lymphocyte density, safety, and efficacy', 'median CD8 + TIL density ratio', 'CD8 + TIL density', 'safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes', 'additional recurrence', 'CD8 + TIL density, safety, and efficacy', 'CD8 + TIL change', 'baseline CD8 + TIL density nor PD-L1 expression level', 'grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1431543', 'cui_str': 'PGRMC1 protein, human'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.159168,"The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P =.97, 95%CI:(-1.07,2.28)).","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. rferrarotto@mdanderson.org.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Rubin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johnson', 'Affiliation': 'Department of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Goepfert', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Phan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Yasir Y', 'Initials': 'YY', 'LastName': 'Elamin', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Danice K', 'Initials': 'DK', 'LastName': 'Torman', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Carla L', 'Initials': 'CL', 'LastName': 'Warneke', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Hessel', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Garden', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Myers', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Faye M', 'Initials': 'FM', 'LastName': 'Johnson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Sikora', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Glisson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3977']
466,31686175,Evidence for positive allosteric modulation of cognitive-enhancing effects of nicotine in healthy human subjects.,"RATIONALE


Cognitive benefits of nicotinic acetylcholine receptor (nAChR) agonists are well established but have generally been of small magnitude and uncertain clinical significance. A way of raising the effect size may be to facilitate agonist-induced responses by co-administering a nAChR positive allosteric modulator (PAM).
OBJECTIVE


The aim was to test whether galantamine, a PAM at several nAChR subtypes, can potentiate the cognitive-enhancing effects of nicotine.
METHODS


Twenty-six adult never-smokers were treated, in a double-blind counterbalanced sequence, with nicotine (7 mg/24 h, transdermally) and galantamine (4 mg, p.o.) combined, nicotine alone, galantamine alone, and double placebo. A low dose of galantamine was chosen to minimize acetylcholinesterase inhibition, which was verified in blood assays. In each condition, participants were tested with three cognitive tasks.
RESULTS


Nicotine significantly improved reaction time (RT) and signal detection in a visuospatial attention task and the Rapid Visual Information Processing Task. Galantamine did not modulate these effects. A trend toward RT reduction by galantamine correlated with acetylcholinesterase inhibition. In a change detection task, there were no effects of nicotine or galantamine alone on accuracy or RT. However, both drugs combined acted synergistically to reduce RT. This effect was not associated with acetylcholinesterase inhibition.
CONCLUSIONS


A pattern consistent with allosteric potentiation of nicotine effects by galantamine was observed on one of six performance measures. This may reflect specific nAChR subtype involvement, or additional pharmacological actions of galantamine may have overshadowed similar interactions on other measures. The finding suggests that allosteric potentiation of nAChR agonist-induced cognitive benefits is possible in principle.",2020,"RESULTS


Nicotine significantly improved reaction time (RT) and signal detection in a visuospatial attention task and the Rapid Visual Information Processing Task.","['Twenty-six adult', 'healthy human subjects']","['nicotine', 'Galantamine', 'nicotinic acetylcholine receptor (nAChR', 'galantamine', 'nicotine alone, galantamine alone, and double placebo']","['accuracy or RT', 'RT reduction', 'reaction time (RT) and signal detection in a visuospatial attention task and the Rapid Visual Information Processing Task']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic Receptors'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection Analysis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}]",26.0,0.126099,"RESULTS


Nicotine significantly improved reaction time (RT) and signal detection in a visuospatial attention task and the Rapid Visual Information Processing Task.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA. bhahn@som.umaryland.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Shrieves', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Cory K', 'Initials': 'CK', 'LastName': 'Olmstead', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Marie B', 'Initials': 'MB', 'LastName': 'Yuille', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Chiappelli', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Edna F R', 'Initials': 'EFR', 'LastName': 'Pereira', 'Affiliation': 'Department of Epidemiology and Public Health, Division of Translational Toxicology, University of Maryland School of Medicine, 10 S. Pine St., Suite 900, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Edson X', 'Initials': 'EX', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Epidemiology and Public Health, Division of Translational Toxicology, University of Maryland School of Medicine, 10 S. Pine St., Suite 900, Baltimore, MD, 21201, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Fawcett', 'Affiliation': 'Department of Epidemiology and Public Health, Division of Translational Toxicology, University of Maryland School of Medicine, 10 S. Pine St., Suite 900, Baltimore, MD, 21201, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05363-4']
467,32272243,Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension.,"BACKGROUND & AIMS


Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing.
METHODS


We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11-40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the dysphagia symptom questionnaire (DSQ) from baseline to week 12 of therapy.
RESULTS


Overall, 93 patients were randomly assigned to groups; the prespecified modified intent to treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, -4. 9 [1.7] vs -7.4 [1.5]; P = .265; week 8, -7.4 [2.1] vs -10.3 [1.8]; P = .288; week 12, -7.5 [1.9] vs -14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5 [0.8] vs -3.3 [0.7]; P = .484; week 8, -3.0 [0.8] vs -4.9 [0.7]; P = .066; week 12, -3.1 [0.8] vs -4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response.
CONCLUSIONS


In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.",2020,"Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5","['9[1.7', '93 patients', 'July 2012 through October 2014) of patients with EoE', '11-40 y old']","['placebo', 'Budesonide Oral Suspension', 'placebo or BOS', 'budesonide oral suspension (BOS', 'BOS']","['least-squares mean (standard error) DSQ (Q2+Q3) scores', 'dysphagia symptom questionnaire (DSQ', 'DSQ and DSQ+pain scores', 'pain (Q4) scores', 'dysphagia and pain scores', 'dysphagia and pain with swallowing', 'severe DSQ and DSQ+pain scores', 'Dysphagia and Pain With Swallowing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",93.0,0.454328,"Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Hudgens', 'Affiliation': 'Clinical Outcome Solutions, Tucson, Arizona.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Vera-Llonch', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.060']
468,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.
Objective


To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.
Design, Setting, and Participants


Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.
Interventions


Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.
Main Outcomes and Measures


The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.
Results


All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
Conclusions and Relevance


Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
469,31163986,Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure.,"Background In EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) empagliflozin significantly reduced the risk of cardiovascular and kidney outcomes in patients with type 2 diabetes mellitus and established cardiovascular disease. Post hoc, we evaluated empagliflozin on kidney outcomes in patients with or without heart failure (HF). Methods and Results Individuals were randomized to empagliflozin 10 mg, 25 mg, or placebo. Prespecified analyses by baseline HF status included risk of incident or worsening nephropathy and estimated glomerular filtration rate slope analyses. Cox proportional hazards models assessed consistency of treatment effect across subgroups. Safety evaluations included kidney-related adverse events. At baseline, 244 (10.5%) and 462 (9.9%) patients had HF in the placebo and empagliflozin groups, respectively. Overall, the incidence of kidney outcome events was numerically higher in patients with than without HF. In the HF group, empagliflozin reduced risk of incident or worsening nephropathy or cardiovascular death by 43% (hazard ratio, 0.57 [95% CI, 0.42-0.77]) and progression to macroalbuminuria by 50% (hazard ratio, 0.50 [0.33-0.75]). After an initial transient decrease, estimated glomerular filtration rate stabilized over time with empagliflozin but gradually declined with placebo. Kidney effects in patients with HF were consistent with those in the overall study population (all P values for interaction >0.05). Across groups, the incidence rate of kidney-related adverse events/100 patient-years was higher in patients with than without HF; however, overall rates were comparable between groups. Conclusions These findings from EMPA-REG OUTCOME support the hypothesis that empagliflozin could reduce the risk of clinically relevant kidney events and may slow progression of chronic kidney disease in individuals with type 2 diabetes mellitus regardless of HF status. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676.",2019,"In the HF group, empagliflozin reduced risk of incident or worsening nephropathy or cardiovascular death by 43% (hazard ratio, 0.57 [95% CI, 0.42-0.77]) and progression to macroalbuminuria by 50% (hazard ratio, 0.50 [0.33-0.75]).","['patients with type 2 diabetes mellitus and established cardiovascular disease', 'individuals with type 2 diabetes mellitus regardless of HF status', 'patients with HF', 'patients with or without heart failure (HF', 'Type 2 Diabetes Mellitus Patients', 'Patients With or Without Heart Failure']","['Empagliflozin', 'empagliflozin', 'placebo']","['kidney-related adverse events', 'kidney outcomes', 'risk of clinically relevant kidney events', 'incidence rate of kidney-related adverse events/100 patient-years', 'Kidney Outcomes', 'Kidney effects', 'risk of incident or worsening nephropathy and estimated glomerular filtration rate slope analyses', 'glomerular filtration rate', 'risk of cardiovascular and kidney outcomes', 'risk of incident or worsening nephropathy or cardiovascular death', 'overall rates', 'incidence of kidney outcome events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.261706,"In the HF group, empagliflozin reduced risk of incident or worsening nephropathy or cardiovascular death by 43% (hazard ratio, 0.57 [95% CI, 0.42-0.77]) and progression to macroalbuminuria by 50% (hazard ratio, 0.50 [0.33-0.75]).","[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.).'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Institut Lorrain du Coeur et des Vaisseaux, Nancy, France (F.Z.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St Michael's Hospital (D.F.), University of Toronto, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital (B.Z.), University of Toronto, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany (A.K.-W., M.v.E., J.G., M.B.).'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany (A.K.-W., M.v.E., J.G., M.B.).'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany (I.Z.).'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany (A.K.-W., M.v.E., J.G., M.B.).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany (A.K.-W., M.v.E., J.G., M.B.).'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah, Salt Lake City (A.K.C.).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Würzburg University Clinic, Germany (A.K.-W., C.W.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.118.005875']
470,30387144,The impact of 2 years of high-intensity exercise training on a model of integrated cardiovascular regulation.,"KEY POINTS


Heart rate variability, a common and easily measured index of cardiovascular dynamics, is the output variable of complicated cardiovascular and respiratory control systems. Both neural and non-neural control mechanisms may contribute to changes in heart rate variability. We previously developed an innovative method using transfer function analysis to assess the effect of prolonged exercise training on integrated cardiovascular regulation. In the present study, we modified and applied this to investigate the effect of 2 years of high-intensity training on circulatory components to tease out the primary effects of training. Our method incorporated the dynamic Starling mechanism, dynamic arterial elastance and arterial-cardiac baroreflex function. The dynamic Starling mechanism gain and arterial-cardiac baroreflex gain were significantly increased in the exercise group. These parameters remained unchanged in the controls. Conversely, neither group experienced a change in dynamic arterial elastance. The integrated cardiovascular regulation gain in the exercise group was 1.34-fold larger than that in the control group after the intervention. In these previously sedentary, otherwise healthy, middle-aged adults, 2 years of high-intensity exercise training improved integrated cardiovascular regulation by enhancing the dynamic Starling mechanism and arterial-cardiac baroreflex sensitivity.
ABSTRACT


Assessing the effects of exercise training on cardiovascular variability is challenging because of the complexity of multiple mechanisms. In a prospective, parallel-group, randomized controlled study, we examined the effect of 2 years of high-intensity exercise training on integrated cardiovascular function, which incorporates the dynamic Starling mechanism, dynamic arterial elastance and arterial-cardiac baroreflex function. Sixty-one healthy participants (48% male, aged 53 years, range 52-54 years) were randomized to either 2 years of exercise training (exercise group: n = 34) or control/yoga group (controls: n = 27). Before and after 2 years, subjects underwent a 6 min recording of beat-by-beat pulmonary artery diastolic pressure (PAD), stroke volume index (SV index), systolic blood pressure (sBP) and RR interval measurements with controlled respiration at 0.2 Hz. The dynamic Starling mechanism, dynamic arterial elastance and arterial-cardiac baroreflex function were calculated by transfer function gain between PAD and SV index; SV index and sBP; and sBP and RR interval, respectively. Fifty-three participants (controls: n = 25; exercise group: n = 28) completed the intervention. After 2 years, the dynamic Starling mechanism gain (Group × Time interaction: P = 0.008) and the arterial-cardiac baroreflex gain (P = 0.005) were significantly increased in the exercise group but remained unchanged in the controls. There was no change in dynamic arterial elastance in either of the two groups. The integrated cardiovascular function gain in the exercise group increased 1.34-fold, whereas there was no change in the controls (P = 0.02). In these previously sedentary, otherwise healthy middle-aged adults, a 2 year programme of high-intensity exercise training improved integrated cardiovascular regulation by enhancing the dynamic Starling mechanism and arterial-cardiac baroreflex sensitivity, without changing dynamic arterial elastance.",2019,"After 2 years, the dynamic Starling mechanism gain (Group × Time interaction: P = 0.008) and the arterial-cardiac baroreflex gain (P = 0.005) were significantly increased in the exercise group but remained unchanged in the controls.","['previously sedentary, otherwise healthy, middle-aged adults, 2 years of high', 'Sixty-one healthy participants (48% male, aged 53\xa0years, range 52-54\xa0years', 'previously sedentary, otherwise healthy middle-aged adults', 'Fifty-three participants (controls: n\xa0= 25; exercise group: n\xa0= 28) completed the intervention']","['high-intensity training', 'exercise training', 'high-intensity exercise training', 'exercise training (exercise group: n\xa0= 34) or control/yoga group', 'prolonged exercise training', 'intensity exercise training']","['dynamic arterial elastance', 'integrated cardiovascular regulation gain', 'pulmonary artery diastolic pressure (PAD), stroke volume index (SV\xa0index), systolic blood pressure (sBP) and RR interval measurements with controlled respiration', 'dynamic Starling mechanism, dynamic arterial elastance and arterial-cardiac baroreflex function', 'arterial-cardiac baroreflex gain', 'dynamic Starling mechanism gain and arterial-cardiac baroreflex gain', 'dynamic Starling mechanism gain', 'integrated cardiovascular function gain']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0428644', 'cui_str': 'Pulmonary artery diastolic pressure (observable entity)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1621793', 'cui_str': 'Starlings'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}]",61.0,0.0231539,"After 2 years, the dynamic Starling mechanism gain (Group × Time interaction: P = 0.008) and the arterial-cardiac baroreflex gain (P = 0.005) were significantly increased in the exercise group but remained unchanged in the controls.","[{'ForeName': 'Michinari', 'Initials': 'M', 'LastName': 'Hieda', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Howden', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Satyam', 'Initials': 'S', 'LastName': 'Sarma', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cornwell', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Lawley', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Samels', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Everding', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Livingston', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Levine', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, and University of Texas Southwestern Medical Centre, TX, USA.'}]",The Journal of physiology,['10.1113/JP276676']
471,31081899,Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.,"BACKGROUND


Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to manage insomnia, the comparative effectiveness between acupuncture and Cognitive Behavioral Therapy for Insomnia (CBT-I) for this disorder is unknown.
METHODS


This randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific points on the body with needles. CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education. We measured insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment (8 weeks) with follow-up until 20 weeks. We used linear mixed-effects models for analyses. All statistical tests were two-sided.
RESULTS


The mean age was 61.5 years and 56.9% were women. CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks. Acupuncture was more effective for pain at the end of treatment; both groups had similar improvements in fatigue, mood, and quality of life and reduced prescription hypnotic medication use. CBT-I was more effective for those who were male (P < .001), white (P = .003), highly educated (P < .001), and had no pain at baseline (P < .001).
CONCLUSIONS


Although both treatments produced meaningful and durable improvements, CBT-I was more effective and should be the first line of therapy. The relative differences in the comparative effectiveness between the two interventions for specific groups should be confirmed in future adequately powered trials to guide more tailored interventions for insomnia.",2019,"CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks.","['The mean age was 61.5\u2009years and 56.9% were women', 'Cancer Survivors']","['Acupuncture', 'Acupuncture Versus Cognitive Behavioral Therapy', 'acupuncture', 'acupuncture and Cognitive Behavioral Therapy']","['no pain', 'insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment', 'CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education', 'insomnia severity', 'fatigue, mood, and quality of life and reduced prescription hypnotic medication use']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.134623,"CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks.","[{'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ''}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'DuHamel', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Frances K', 'Initials': 'FK', 'LastName': 'Barg', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gehrman', 'Affiliation': ''}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djz050']
472,31272709,Effects of a High-fat Meal on the Pharmacokinetics of the VEGFR Inhibitor Fruquintinib: A Randomized Phase I Study in Healthy Subjects.,"PURPOSE


Fruquintinib is a potent and highly selective oral small-molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor and demonstrates promising activity against a broad spectrum of cancer types. The objective of the study was to investigate the tolerability and effect of high-fat food on the pharmacokinetic profile of a fruquintinib capsule in healthy Chinese subjects.
METHODS


Healthy Chinese male subjects aged between 18 and 45 years were enrolled in the study. The study included 2 phases: a dose-escalation phase and a food effect-assessment phase. In the dose-escalation phase, subjects were administered a single dose of fruquintinib (2, 3, or 4 mg) in the fasted state. In the food effect-assessment phase, subjects were administered a 4-mg fruquintinib capsule in the fasted and fed states, respectively, in 2 cycles. Blood samples for pharmacokinetic analysis were collected at the designated time points. Tolerability was assessed throughout the study by physical examination including vital sign measurements, clinical laboratory tests, 12-lead ECG, clinical assessments, and monitoring for and spontaneous reporting of adverse events.
FINDINGS


Twenty-nine eligible male subjects were enrolled in the study, including 9 in the dose-escalation phase and 20 in the food effect-assessment phase. In the food effect-assessment phase, the ratios (90% CI) of the geometric mean AUC 0-∞  and C max  values for fruquintinib in the fed state to those observed in the fasted state were 97.2% (94.0%-100.4%) and 82.9% (76.7%-89.5%), respectively. The mean (SD) T max  values of fruquintinib were 3.0 (1.0) and 5.6 (4.5) hours in the fasted and fed states, respectively. The most common adverse events possibly related to the study drug were elevated blood uric acid, diarrhea, and decreased white blood cell count.
IMPLICATIONS


The overall bioavailability of the evaluated formulation of fruquintinib was not affected by the consumption of a high-fat, high-calorie meal prior to dosing. However, the consumption of a high-fat, high-calorie meal prior to dosing prolonged the T max . These results indicate that the fruquintinib capsule can be administered with or without food. ClinicalTrials.gov identifier: NCT01955304.",2019,"The most common adverse events possibly related to the study drug were elevated blood uric acid, diarrhea, and decreased white blood cell count.
","['Healthy Subjects', 'Twenty-nine eligible male subjects were enrolled in the study, including 9 in the dose-escalation phase and 20 in the food effect-assessment phase', 'Healthy Chinese male subjects aged between 18 and 45 years were enrolled in the study', 'healthy Chinese subjects']",['High-fat Meal'],"['overall bioavailability', 'blood uric acid, diarrhea, and decreased white blood cell count', 'mean (SD) T max  values of fruquintinib', 'vital sign measurements, clinical laboratory tests, 12-lead ECG, clinical assessments, and monitoring for and spontaneous reporting of adverse events', 'Tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0373739', 'cui_str': 'Blood uric acid'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3640966'}, {'cui': 'C2963216'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",29.0,0.0310085,"The most common adverse events possibly related to the study drug were elevated blood uric acid, diarrhea, and decreased white blood cell count.
","[{'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Laboratory of Immunology and Virology, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China. Electronic address: ymliu@shxh-centerlab.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.05.014']
473,31219558,A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa.,"CONTEXT


Anorexia nervosa (AN) is a psychiatric illness with considerable morbidity and no approved medical therapies. We have shown that relative androgen deficiency in AN is associated with greater depression and anxiety symptom severity.
OBJECTIVE


To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN.
DESIGN


Double-blind, randomized, placebo-controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women.
INTERVENTION


Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks.
MAIN OUTCOME MEASURES


Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors.
RESULTS


Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: -2.9 ± 4.9 (testosterone) vs -3.0 ± 5.0 (placebo), P = 0.72; HAM-A: -4.5 ± 5.3 (testosterone) vs -4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo.
CONCLUSION


Low-dose testosterone therapy for 24 weeks was associated with less weight gain-and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms-compared with placebo in women with AN.",2019,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","['women with anorexia nervosa', '90 women, 18-45 years, with AN and free testosterone levels below the median for healthy women']","['testosterone', 'placebo', 'low-dose testosterone therapy', 'Testosterone therapy', 'Transdermal testosterone', 'placebo patch']","['HAM-D score', 'eating disorder scores', 'depression, anxiety, or disordered eating symptoms ', 'weight gain ', 'depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors', 'mean HAM-D and HAM-A scores', 'Mean BMI', 'androgenic side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.738216,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schorr', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erinne', 'Initials': 'E', 'LastName': 'Meenaghan', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Bachmann', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Kamryn T', 'Initials': 'KT', 'LastName': 'Eddy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Kreiger-Benson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Herzog', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Koman', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Keane', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'Cambridge Eating Disorder Center, Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klibanski', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Miller', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00828']
474,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
475,32265117,The Impact of Chemotherapy Completion on the Efficacy of Irinotecan in the Preoperative Chemoradiotherapy of Locally Advanced Rectal Cancer: An Expanded Analysis of the CinClare Phase III Trial.,"BACKGROUND


This study explored the impact of chemotherapy completion on irinotecan efficacy in preoperative chemoradiotherapy in patients with locally advanced rectal cancer.
PATIENTS AND METHODS


Patients with locally advanced rectal cancer (T3/4 and/or LN+) receiving neoadjuvant chemoradiotherapy were enrolled. All received preoperative pelvic radiotherapy concurrently with capecitabine and irinotecan, followed by a course of XELIRI and surgery. Patients were divided into low- and high-completion groups based on their cycles of concurrent irinotecan (1-3 or 4-5). Tumor response was compared. Significant risk factors for low completion were investigated by logistic regression modeling then a predictive nomogram was built.
RESULTS


Overall, 371 patients were enrolled, with 102 patients from CinClare phase III trial (NCT02605265). Proportions of patients with low and high completion were 38.8% and 61.2%, respectively. In the general population, the complete tumor response rates (combining sustained clinical complete response and pathologic complete response) were 21.5% and 33.6% in the low- and high-completion groups, respectively (P = .02), which were 24.2% versus 43.5% in the CinClare group (P = .08). The pathologic complete response rates were 19.4% and 26.1%, respectively (P = .19). A predictive nomogram was established and 3 different risk groups (low, intermediate, and high risk) were identified, with high completion rates of 29.2%, 50.0%, and 68.9%, respectively (P < .0001).
CONCLUSION


Our analysis suggested higher completion of concurrent irinotecan was associated with better tumor response for patients with locally advanced rectal cancer with UGT1A1∗1∗1 or UGT1A1∗1∗28 phenotypes in the neoadjuvant setting, and at least 4 cycles was recommended.",2020,"The pathologic complete response rates were 19.4% and 26.1%, respectively (P = .19).","['Patients with locally advanced rectal cancer (T3/4 and/or LN+) receiving neoadjuvant chemoradiotherapy were enrolled', '371 patients were enrolled, with 102 patients from CinClare phase III trial (NCT02605265', 'Locally Advanced Rectal Cancer', 'patients with locally advanced rectal cancer']","['preoperative pelvic radiotherapy concurrently with capecitabine and irinotecan', 'Irinotecan', 'chemotherapy completion', 'concurrent irinotecan', 'irinotecan', 'preoperative chemoradiotherapy']","['pathologic complete response rates', 'Tumor response', 'complete tumor response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",371.0,0.123734,"The pathologic complete response rates were 19.4% and 26.1%, respectively (P = .19).","[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China; Department of Cyberknife Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Juefeng', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: leoon.zhu@gmail.com.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.01.004']
476,31266654,Bioequivalence and Food Effect of Dapagliflozin/Saxagliptin/Metformin Extended-release Fixed-combination Drug Products Compared With Coadministration of the Individual Components in Healthy Subjects.,"PURPOSE


Fixed-combination drug products (FCDPs) for patients with type 2 diabetes mellitus (T2DM) may show efficacy comparable to their individual components (ICs) while improving adherence to treatment. This study evaluated the bioequivalence and safety of 2 dapagliflozin/saxagliptin/metformin extended-release (XR) FCDPs relative to their ICs: saxagliptin and dapagliflozin/metformin XR.
METHODS


This randomized, open-label, single-dose, single-center crossover study was conducted in 84 healthy subjects aged 18-55 years. The primary objective was to evaluate the fed-state bioequivalence of a dapagliflozin 5-mg/saxagliptin 2.5-mg/metformin 1000-mg XR FCDP and a dapagliflozin 10-mg/saxagliptin 5-mg/metformin 1000-mg XR FCDP relative to the ICs. Secondary objectives included the evaluation of the effect of food on the pharmacokinetic (PK) parameters of saxagliptin, dapagliflozin, and metformin in both FCDPs and characterization of the PK parameters of the active metabolite of saxagliptin, 5-hydroxy saxagliptin, in healthy subjects. PK parameters (AUC 0-∞ , AUC 0-t , and C max ) were used to assess the bioequivalence of the 2 FCDPs with their ICs. The C max  and AUC 0-t  of the study drugs were compared between female and male subjects to assess sex differences in exposure. Safety and tolerability of both FCDPs and ICs were also assessed with adverse events, vital signs (systolic and diastolic blood pressures and pulse rate), 12-lead ECG, physical examinations, and laboratory assessments.
FINDINGS


Both dapagliflozin/saxagliptin/metformin XR FCDPs were bioequivalent to their ICs. For the dapagliflozin 5-mg/saxagliptin 2.5-mg/metformin 1000-mg XR FCDP, the 90% CI for the geometric mean ratio of dapagliflozin C max  was slightly above the 80%-125% bioequivalence limit, which is unlikely to be clinically relevant. Food delayed the absorption of the study drugs in both FCDPs, which is unlikely to have a clinically relevant impact on efficacy. In both cohorts, exposure was higher in female subjects compared with male subjects, potentially due to the lower body weight of the female subjects. The safety profile and tolerability of the FCDPs were similar to those of their ICs, and no deaths or serious adverse events were reported.
IMPLICATIONS


These data support the use of the dapagliflozin/saxagliptin/metformin XR FCDP in patients with T2DM. ClinicalTrials.gov identifier: NCT03169959.",2019,Both dapagliflozin/saxagliptin/metformin XR FCDPs were bioequivalent to their ICs.,"['patients with type 2 diabetes mellitus (T2DM', 'healthy subjects', 'Healthy Subjects', '84 healthy subjects aged 18-55 years', 'patients with T2DM']","['dapagliflozin 10-mg/saxagliptin 5-mg/metformin', 'saxagliptin 2.5-mg/metformin', 'dapagliflozin/saxagliptin/metformin', 'dapagliflozin/saxagliptin/metformin XR FCDPs', 'dapagliflozin/saxagliptin/metformin XR FCDP', 'Fixed-combination drug products (FCDPs', 'dapagliflozin 5-mg/saxagliptin 2.5-mg/metformin 1000-mg XR FCDP and', 'dapagliflozin/metformin XR', 'Dapagliflozin/Saxagliptin/Metformin', 'dapagliflozin']","['safety profile and tolerability', 'geometric mean ratio of dapagliflozin C max', 'deaths or serious adverse events', 'adverse events, vital signs (systolic and diastolic blood pressures and pulse rate), 12-lead ECG, physical examinations, and laboratory assessments', 'PK parameters (AUC 0-∞ , AUC 0-t , and C max ', 'evaluation of the effect of food on the pharmacokinetic (PK) parameters of saxagliptin, dapagliflozin, and metformin in both FCDPs and characterization of the PK parameters of the active metabolite of saxagliptin, 5-hydroxy saxagliptin', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4477765', 'cui_str': 'dapagliflozin 10 MG / saxagliptin 5 MG [Qtern]'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2718467', 'cui_str': 'saxagliptin 2.5 MG'}, {'cui': 'C4059158', 'cui_str': 'dapagliflozin / saxagliptin'}, {'cui': 'C0067265', 'cui_str': 'N(beta)-fumarylcarboxyamido-2,3-diaminopropionic acid'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3700400', 'cui_str': 'dapagliflozin / Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3181779', 'cui_str': '5-hydroxysaxagliptin'}]",84.0,0.0303916,Both dapagliflozin/saxagliptin/metformin XR FCDPs were bioequivalent to their ICs.,"[{'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA. Electronic address: weifeng.tang@astrazeneca.com.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Engman', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Covance Laboratories Inc, Madison, WI, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dayton', 'Affiliation': 'Covance Laboratories Inc, Madison, WI, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.05.015']
477,30549292,Improvements in Histologic Features and Diagnosis Associated With Improvement in Fibrosis in Nonalcoholic Steatohepatitis: Results From the Nonalcoholic Steatohepatitis Clinical Research Network Treatment Trials.,"Hepatocellular injury and inflammation are believed to be the primary drivers of fibrogenesis that ultimately lead to cirrhosis in patients with nonalcoholic steatohepatitis (NASH). This study sought associations between observed improvements in fibrosis with improvement in specific histologic features, nonalcoholic fatty liver disease activity score (NAS) ≥2, diagnostic category, and primary histologically based outcomes of two adult NASH treatment trials. The primary outcome for the study was fibrosis improvement from baseline to end of treatment, defined as a 1-point or more improvement in fibrosis stage. This is a retrospective analysis of biopsy data collected from the NASH Clinical Research Network Pathology Committee of Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with NASH Trial (PIVENS) and Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial (FLINT) baseline and final biopsies. Treatment group-adjusted univariable and multivariable logistic regression models related improvement in fibrosis to improvements in other histologic variables, resolution of steatohepatitis, and improvement in the NAS ≥2. In PIVENS 221 subjects had baseline and 96-week biopsies, and in FLINT 200 subjects had baseline and 72-week biopsies. Improvement in fibrosis was found in 38% of PIVENS and 29% of FLINT biopsies; fibrosis improvement was more likely in treated than placebo subjects in both studies. Controlling for treatment group, fibrosis improvement was associated most strongly with resolution of NASH (PIVENS, odds ratio [OR], 3.9; 95% confidence interval [CI] 2.0-7.6; P < 0.001; FLINT, OR, 8.0; 95% CI 3.1-20.9; P < 0.001), and improved NAS by ≥2 (PIVENS, OR, 2.4; 95% CI 1.3-4.3; P = 0.003; FLINT, OR, 4.2; 95% CI 2.1-8.3; P < 0.001). Improvement in histologic features associated with improved fibrosis for both studies included steatosis, ballooning, Mallory-Denk bodies, and portal, but not lobular, inflammation. Conclusion: These findings support a strong link between histologic resolution of steatohepatitis with improvement in fibrosis in NASH.",2019,"Improvement in histologic features associated with improved fibrosis for both studies included steatosis, ballooning, Mallory-Denk bodies, and portal, but not lobular, inflammation.","['patients with nonalcoholic steatohepatitis (NASH', 'In PIVENS 221 subjects had baseline and 96-week biopsies, and in FLINT 200 subjects had baseline and 72-week biopsies', 'Nondiabetic Patients with NASH']","['Pioglitazone versus Vitamin E versus Placebo', 'placebo']","['fibrosis stage', 'fibrosis improvement', 'NAS', 'specific histologic features, nonalcoholic fatty liver disease activity score (NAS) ≥2, diagnostic category', 'Improvement in fibrosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0303753', 'cui_str': 'Flintstone'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",221.0,0.455802,"Improvement in histologic features associated with improved fibrosis for both studies included steatosis, ballooning, Mallory-Denk bodies, and portal, but not lobular, inflammation.","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brunt', 'Affiliation': 'Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Wilson', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, VA.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Saint Louis University School of Medicine, St. Louis, MO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30418']
478,32176657,Individually Tailored Internet-Based Cognitive-Behavioral Therapy for Daily Functioning in Patients with Parkinson's Disease: A Randomized Controlled Trial.,"BACKGROUND


Parkinson's disease (PD) is often associated with psychological distress and lowered daily functioning. The availability of psychological interventions tailored for people with Parkinson is very limited.
OBJECTIVE


To study if guided individually-tailored internet-based cognitive behavioral therapy (ICBT) provide additional value to standard medical treatment for PD.
METHODS


Seventy-seven individuals with PD and self-reported problems with general function measured with the Work and Social Adjustment Scale (WSAS > 15) were randomized to 10 weeks of either ICBT combined with standard medical treatment, or standard medical treatment plus being on waitlist to ICBT (CONTROL). Change in the main outcome WSAS, as well as secondary measures such as quality of life, depression, anxiety and insomnia symptoms were investigated post treatment.
RESULTS


Participants receiving ICBT reported significantly higher functioning after treatment (WSAS group difference -4.56, controlled effect size g = 0.69, significant group by time interaction, Wχ2= 26.23, p = 0.001). However, only around one third of participants in the treatment group were classified as treatment responders, defined as having a 30% reduction on the WSAS post treatment. Patient involvement and ratings of ICBT credibility were high. Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL. There were also positive effects on Parkinson-specific function and quality of life in the treatment group.
CONCLUSIONS


ICBT as an addition to standard medical treatment was credible and improved functioning for some individuals with PD. Still, the treatment needs further development in order to help a larger proportion of individuals with PD.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02627885.",2020,"Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL.","['Seventy-seven individuals with PD and self-reported problems with general function measured with the Work and Social Adjustment Scale (WSAS', ""Parkinson's disease (PD"", ""Patients with Parkinson's Disease"", 'people with Parkinson']","['ICBT', 'ICBT combined with standard medical treatment, or standard medical treatment plus being on waitlist to ICBT', 'guided individually-tailored internet-based cognitive behavioral therapy (ICBT', 'Individually Tailored Internet-Based Cognitive-Behavioral Therapy']","['Symptoms of anxiety, depression and insomnia symptoms', 'Parkinson-specific function and quality of life', 'ICBT credibility', 'quality of life, depression, anxiety and insomnia symptoms']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}]",77.0,0.0858481,"Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kraepelien', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schibbye', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Månsson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Riggare', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Lindefors', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Neuroscience, Section of Neurology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",Journal of Parkinson's disease,['10.3233/JPD-191894']
479,30860570,"BEECH: a dose-finding run-in followed by a randomised phase II study assessing the efficacy of AKT inhibitor capivasertib (AZD5363) combined with paclitaxel in patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population.","BACKGROUND


BEECH investigated the efficacy of capivasertib (AZD5363), an oral inhibitor of AKT isoforms 1-3, in combination with the first-line weekly paclitaxel for advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and in a phosphoinositide 3-kinase, catalytic, alpha polypeptide mutation sub-population (PIK3CA+).
PATIENTS AND METHODS


BEECH consisted of an open-label, phase Ib safety run-in (part A) in 38 patients with advanced breast cancer, and a randomised, placebo-controlled, double-blind, phase II expansion (part B) in 110 women with ER+/HER2- metastatic breast cancer. In part A, patients received paclitaxel 90 mg/m2 (days 1, 8 and 15 of a 28-day cycle) with capivasertib taken twice daily (b.i.d.) at two intermittent ascending dosing schedules. In part B, patients were randomly assigned, stratified by PIK3CA mutation status, to receive paclitaxel with either capivasertib or placebo. The primary end point for part A was safety to recommend a dose and schedule for part B; primary end points for part B were progression-free survival (PFS) in the overall and PIK3CA+ sub-population.
RESULTS


Capivasertib was well tolerated, with a 400 mg b.i.d. 4 days on/3 days off treatment schedule selected in part A. In part B, median PFS in the overall population was 10.9 months with capivasertib versus 8.4 months with placebo [hazard ratio (HR) 0.80; P = 0.308]. In the PIK3CA+ sub-population, median PFS was 10.9 months with capivasertib versus 10.8 months with placebo (HR 1.11; P = 0.760). Based on the Common Terminology Criteria for Adverse Event v4.0, the most common grade ≥3 adverse events in the capivasertib group were diarrhoea, hyperglycaemia, neutropoenia and maculopapular rash. Dose intensity of paclitaxel was similar in both groups.
CONCLUSIONS


Capivasertib had no apparent impact on the tolerability and dose intensity of paclitaxel. Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.ClinicalTrials.gov: NCT01625286.",2019,Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.,"['38 patients with advanced breast cancer', 'patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population', '110 women with ER+/HER2- metastatic breast cancer', 'metastatic breast cancer patients']","['placebo', 'capivasertib (AZD5363', 'paclitaxel', 'paclitaxel with either capivasertib or placebo', 'BEECH', 'AKT inhibitor capivasertib (AZD5363) combined with paclitaxel']","['median PFS', 'progression-free survival (PFS', 'tolerability and dose intensity of paclitaxel', 'diarrhoea, hyperglycaemia, neutropoenia and maculopapular rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0950075', 'cui_str': 'Fagaceae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash (morphologic abnormality)'}]",110.0,0.148122,Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.,"[{'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Unit, The Royal Marsden NHS Foundation Trust, London, UK; Breast Cancer Now Research Centre, The Institute of Cancer Research, London, UK. Electronic address: Nick.Turner@icr.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alarcón', 'Affiliation': 'Clinical Oncology Department, British American Hospital, Lima, Peru.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Medical Oncology, Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Philco', 'Affiliation': 'Peruvian Institute of Oncology Radiotherapy, Lima, Peru.'}, {'ForeName': 'Y A', 'Initials': 'YA', 'LastName': 'López Chuken', 'Affiliation': 'University Hospital, Monterrey, Mexico.'}, {'ForeName': 'M-P', 'Initials': 'MP', 'LastName': 'Sablin', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Curie Institute, Paris, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gómez Villanueva', 'Affiliation': 'Clinical Oncology Unit, Private Hemato-Oncology Center, Toluca, Mexico.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Pérez-Fidalgo', 'Affiliation': 'Medical Oncology Unit, INCLIVA Biomedical Research Institute, University Clinical Hospital of Valencia, Valencia; CIBERONC, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'S Y A', 'Initials': 'SYA', 'LastName': 'Cheung', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Corcoran', 'Affiliation': 'Precision Medicine and Genomics, IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cullberg', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Davies', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'de Bruin', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'J P O', 'Initials': 'JPO', 'LastName': 'Lindemann', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maudsley', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moschetta', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Outhwaite', 'Affiliation': 'Anchora Consultancy Ltd, Devon, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pass', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rugman', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz086']
480,32173628,Long-term effect of patient decision aids on use of joint replacement and health care costs.,"OBJECTIVE


Shared decision-making supported by patient decisions aids may improve care and reduce healthcare costs for persons considering total joint replacement. Observational studies and randomized controlled trials (RCTs) have evaluated the short-term impact of decision aids on uptake of surgery and costs, however the long-term effects are unclear. This analysis aimed to evaluate the effect of patient decision aids on 1) use of joint replacement up to 7-years of follow-up, and 2) osteoarthritis-related health system costs.
METHODS


324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n = 161) or usual care (n = 163) had their trial and health administrative data linked. The proportion undergoing surgery up to 7-years were compared using cumulative incidence plots and competing risk regression. Mean per-patient costs were compared using two sample t-tests.
RESULTS


At 2-years, 119 of 161 (73.9%) patients in the decision aid arm and 129 of 163 (79.1%) patients in the usual care arm had surgery. Between two and 7-years, 17 additional patients in both the decision aid (of 42, 40.4%) and usual care (of 34, 50.0%) arms underwent surgery. At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
CONCLUSIONS


This is the first study to assess the long-term impact of decision aids on use of joint replacement and healthcare costs. These results are not conclusive but can inform future trial design.
CLINICAL TRIAL REGISTRATION


The full trial protocol is available at ClinicalTrials.Gov (NCT00911638).",2020,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","['324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n\xa0=\xa0161) or usual care (n\xa0=\xa0163) had their trial and health administrative data linked', 'persons considering total joint replacement']","['patient decision aids', 'decision aids']","['usual care', 'mean per-patient costs', 'Mean per-patient costs', 'likelihood of undergoing surgery']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",,0.137968,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trenaman', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'The University of Manchester, Manchester, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hawker', 'Affiliation': 'The University of Toronto, Toronto, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bansback', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada. Electronic address: nick.bansback@ubc.ca.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.019']
481,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
482,32255395,Subacute effects of the psychedelic ayahuasca on the salience and default mode networks.,"BACKGROUND


Neuroimaging studies have just begun to explore the acute effects of psychedelics on large-scale brain networks' functional organization. Even less is known about the neural correlates of subacute effects taking place days after the psychedelic experience. This study explores the subacute changes of primary sensory brain networks and networks supporting higher-order affective and self-referential functions 24 hours after a single session with the psychedelic ayahuasca.
METHODS


We leveraged task-free functional magnetic resonance imaging data 1 day before and 1 day after a randomized placebo-controlled trial exploring the effects of ayahuasca in naïve healthy participants (21 placebo/22 ayahuasca). We derived intra- and inter-network functional connectivity of the salience, default mode, visual, and sensorimotor networks, and assessed post-session connectivity changes between the ayahuasca and placebo groups. Connectivity changes were associated with Hallucinogen Rating Scale scores assessed during the acute effects.
RESULTS


Our findings revealed increased anterior cingulate cortex connectivity within the salience network, decreased posterior cingulate cortex connectivity within the default mode network, and increased connectivity between the salience and default mode networks 1 day after the session in the ayahuasca group compared to placebo. Connectivity of primary sensory networks did not differ between groups. Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
CONCLUSION


These findings provide preliminary evidence for subacute functional changes induced by the psychedelic ayahuasca on higher-order cognitive brain networks that support interoceptive, affective, and self-referential functions.",2020,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
",['naïve healthy participants (21 placebo/22 ayahuasca'],"['ayahuasca', 'psychedelic ayahuasca', 'placebo']","['anterior cingulate cortex connectivity', 'Hallucinogen Rating Scale scores', 'altered somesthesia scores', 'posterior cingulate cortex connectivity', 'salience default mode network connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234209', 'cui_str': 'Somatic sensation'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.144697,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pasquini', 'Affiliation': 'Memory and Aging Center, University of California, San Francisco, United States of America.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Draulio B', 'Initials': 'DB', 'LastName': 'Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120909409']
483,31133672,Intermittent screening and treatment with dihydroartemisinin-piperaquine and intermittent preventive therapy with sulfadoxine-pyrimethamine have similar effects on malaria antibody in pregnant Malawian women.,"In a randomised trial comparing intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine (DP) and intermittent preventive therapy against malaria in pregnancy (IPT) with sulfadoxine-pyrimethamine (SP) in Malawi, the impacts of IST-DP and IPT-SP on the development and maintenance of malaria antibody immunity were compared. Pregnant Malawian women were randomised to receive IST-DP or IPT-SP. In a nested study, paired enrolment and delivery plasma samples from 681 women were assayed for antibodies against recombinant antigens and for IgG and opsonising antibodies to antigens found on infected erythrocytes (IEs). At delivery, antibody responses did not differ between study arms. Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable. Overall, changes in antibody responses over pregnancy did not differ by treatment arm. Stratifying by gravidity, antibody to schizont extract decreased more in multigravidae receiving IST-DP than IPT-SP. There was minimal impact of treatment arm on the development and maintenance of malaria immunity. While antibodies to recombinant antigens declined between enrolment and delivery, antibodies directed against IEs tended to be more stable, suggesting longer-lasting protection.Clinical trial registration: Pa n African Clinical Trials Registry (PACTR201103000280319) 14/03/2011. URL: http://www.isrctn.com/ISRCTN69800930 .",2019,"Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable.","['Pregnant Malawian women', 'pregnant Malawian women', '681 women were assayed for antibodies against recombinant antigens and for IgG and opsonising antibodies to antigens found on infected erythrocytes (IEs']","['sulfadoxine-pyrimethamine', 'intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine (DP', 'IST-DP or IPT-SP', 'dihydroartemisinin-piperaquine', 'sulfadoxine-pyrimethamine (SP']","['malaria antibody', 'antibody responses', 'antibody responses over pregnancy', 'development and maintenance of malaria immunity']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0443723', 'cui_str': 'Malaria antibody (substance)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",681.0,0.0416564,"Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. andrew.teo@uqconnect.edu.au.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mwayiwawo', 'Initials': 'M', 'LastName': 'Madanitsa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mwapasa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Linda Kalilani', 'Initials': 'LK', 'LastName': 'Phiri', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Buffet', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Karahalios', 'Affiliation': 'Centre of Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Narum', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institute of Health, Rockville, Maryland, USA.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rogerson', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. sroger@unimelb.edu.au.'}]",Scientific reports,['10.1038/s41598-019-44340-x']
484,31138860,Short-term changes in frequencies of circulating leukocytes associated with narrowband UVB phototherapy in people with clinically isolated syndrome.,"Clinically isolated syndrome (CIS) is the earliest clinical episode in multiple sclerosis (MS). Low environmental exposure to UV radiation is implicated in risk of developing MS, and therefore, narrowband UVB phototherapy might delay progression to MS in people with CIS. Twenty individuals with CIS were recruited, and half were randomised to receive 24 sessions of narrowband UVB phototherapy over a period of 8 weeks. Here, the effects of narrowband UVB phototherapy on the frequencies of circulating immune cells and immunoglobulin levels after phototherapy are reported. Peripheral blood samples for all participants were collected at baseline, and 1, 2, 3, 6 and 12 months after enrolment. An extensive panel of leukocyte populations, including subsets of T cells, B cells, monocytes, dendritic cells, and natural killer cells were examined in phototherapy-treated and control participants, and immunoglobulin levels measured in serum. There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals. Since B cells are increasingly targeted by MS therapies, the effects of narrowband UVB phototherapy in people with MS should be investigated further.",2019,"There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals.","['Twenty individuals with CIS', 'people with CIS', 'people with clinically isolated syndrome']",['narrowband UVB phototherapy'],"['frequencies of circulating immune cells and immunoglobulin levels', 'Peripheral blood samples', 'frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes', 'subsets of T cells, B cells, monocytes, dendritic cells, and natural killer cells']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2921627', 'cui_str': 'Clinically isolated syndrome'}]","[{'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy (procedure)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0428536', 'cui_str': 'Immunoglobulin level - finding'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}]",20.0,0.0579403,"There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Trend', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Anderson P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cha', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cooper', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Geldenhuys', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Marzena J', 'Initials': 'MJ', 'LastName': 'Fabis-Pedrini', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Carroll', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Cole', 'Affiliation': 'St John of God Dermatology Clinic, St John of God Hospital, Perth, WA, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Booth', 'Affiliation': 'University of Sydney, Faculty of Medicine and Health, Westmead Institute for Medical Research, Westmead, Australia.'}, {'ForeName': 'Robyn M', 'Initials': 'RM', 'LastName': 'Lucas', 'Affiliation': 'National Centre for Epidemiology & Population Health, Research School of Population Health, Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Martyn A', 'Initials': 'MA', 'LastName': 'French', 'Affiliation': 'UWA Medical School and School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Byrne', 'Affiliation': 'University of Sydney, Faculty of Medicine and Health, Westmead Institute for Medical Research, Westmead, Australia.'}, {'ForeName': 'Allan G', 'Initials': 'AG', 'LastName': 'Kermode', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Prue H', 'Initials': 'PH', 'LastName': 'Hart', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia. prue.hart@telethonkids.org.au.'}]",Scientific reports,['10.1038/s41598-019-44488-6']
485,31142776,Top-down Effects on Empathy for Pain in Adults with Autistic Traits.,"While empathic responses of individuals with autism-spectrum disorder have been reported to be modulated by top-down attention, it remains unclear whether empathy for pain in typically developing individuals with autistic traits also involves such top-down modulation mechanisms. This study employed the autism-spectrum quotient (AQ) to quantify autistic traits in a group of 1,231 healthy adults. Two subset groups (High-AQ and Low-AQ groups) were randomly selected from the highest and lowest 10% AQ scores respectively. We explored whether participants in both groups would differ in their response to others' pain when their attention was directed toward (A-P tasks) or away (A-N tasks) from pain cues in auditory and visual experimental modalities. Compared to Low-AQ individuals, High-AQ individuals exhibited more suppressed N1 and P2 amplitudes in response to painful vocal cues in auditory A-N tasks. This suggests suppressed attentional and emotional processes of empathy for pain when High-AQ individuals have their attention directed away from others' pain cues. No significant difference was found between both groups in the auditory A-P task, nor in the visual A-P and A-N tasks. These results suggest that top-down attention modulation of cortical empathic responses to others' vocal pain is influenced by autistic traits.",2019,"No significant difference was found between both groups in the auditory A-P task, nor in the visual A-P and A-N tasks.","['Adults with Autistic Traits', 'individuals with autism-spectrum disorder', '1,231 healthy adults']",[],"['autism-spectrum quotient (AQ', 'Empathy for Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",1231.0,0.0666187,"No significant difference was found between both groups in the auditory A-P task, nor in the visual A-P and A-N tasks.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'School of Mathematical Sciences, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Zuoshan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Applied Psychology, Chongqing Normal University, Chongqing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'College of Psychology, Shenzhen University, Shenzhen, China. ww.peng0923@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-44400-2']
486,30611005,Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials.,"PURPOSE


While antiepileptic drug (AED) treatment effectiveness is traditionally assessed based on seizure frequency reduction (SFR), the overall value of AEDs in managing epilepsy and associated sequelae may be best assessed by how patients feel and function in terms of overall health-related quality of life (HRQoL). We conducted a pooled analysis of the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire from two phase 3 trials to explore the effect of response to conversion to eslicarbazepine acetate (ESL) monotherapy on HRQoL.
METHODS


Data were pooled from two multicenter, randomized, double-blind, historical control phase 3 trials examining conversion to ESL monotherapy in adults with inadequately controlled partial-onset seizures (POS). The relationship between HRQoL and ESL treatment response was examined through the analysis of week 18 QOLIE-31 scores between patients who met the SFR ≥50% threshold (responders) and patients with SFR <50% (nonresponders). The analysis was conducted in the efficacy population (intent-to-treat (ITT) patients who entered the AED taper/conversion period) and completer population (efficacy patients who completed the ESL monotherapy period) and was repeated using an SFR ≥75% threshold.
RESULTS


In the efficacy population, week 18 QOLIE-31 total score least squares mean (LSM) was significantly higher for responders with ≥50% SFR (LSM difference: 3.0; 95% confidence interval (CI): 0.2-5.8; p = 0.037) and with ≥75% SFR (LSM difference: 7.0; 95% CI: 3.6-10.3; p < 0.001) than nonresponders. In the completer population, overall quality of life (QoL) (LSM difference: 5.1; 95% CI: 1.5-8.6; p = 0.006) and social functioning (LSM difference: 5.4; 95% CI: 0.1-10.7; p = 0.046) were significantly higher for responders with ≥50% SFR than nonresponders, and all domain LSMs were higher for responders with ≥75% SFR (all p < 0.05) than nonresponders.
CONCLUSIONS


This analysis of data from the phase 3 trials demonstrated significantly higher HRQoL among ESL responders with SFR of ≥75% and also at the lower SFR threshold of ≥50% compared with nonresponders.",2019,"In the efficacy population, week 18 QOLIE-31 total score least squares mean (LSM) was significantly higher for responders with ≥50% SFR (LSM difference: 3.0; 95% confidence interval (CI):","['adults with inadequately controlled partial-onset seizures (POS', 'population (intent-to-treat (ITT) patients who entered the AED taper/conversion period) and completer population (efficacy patients who completed the ESL monotherapy period) and was repeated using an SFR ≥75% threshold', 'patients treated with']","['eslicarbazepine acetate (ESL) monotherapy', 'ESL monotherapy', 'eslicarbazepine acetate monotherapy']","['domain LSMs', 'overall quality of life (QoL', 'social functioning', 'efficacy', 'Health-related quality of life', 'QOLIE-31 total score least squares mean (LSM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.499293,"In the efficacy population, week 18 QOLIE-31 total score least squares mean (LSM) was significantly higher for responders with ≥50% SFR (LSM difference: 3.0; 95% confidence interval (CI):","[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Consultant and Yale University, 2207 Bancroft St., Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Krithika', 'Initials': 'K', 'LastName': 'Rajagopalan', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America.'}, {'ForeName': 'Kathryn Plante', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Market Access Services, Inc., 901 Washingtonian Blvd., Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: david.blum@sunovion.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2018.12.003']
487,31501887,"Afatinib versus methotrexate as second-line treatment in Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3): an open-label, randomised phase III trial.","BACKGROUND


Treatment options are limited for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) following progression after first-line platinum-based therapy, particularly in Asian countries.
PATIENTS AND METHODS


In this randomised, open-label, phase III trial, we enrolled Asian patients aged ≥18 years, with histologically or cytologically confirmed recurrent/metastatic HNSCC following first-line platinum-based therapy who were not amenable for salvage surgery or radiotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0/1. Patients were randomised (2 : 1) to receive oral afatinib (40 mg/day) or intravenous methotrexate (40 mg/m2/week), stratified by ECOG performance status and prior EGFR-targeted antibody therapy. The primary end point was progression-free survival (PFS) assessed by an independent central review committee blinded to treatment allocation.
RESULTS


A total of 340 patients were randomised (228 afatinib; 112 methotrexate). After a median follow-up of 6.4 months, afatinib significantly decreased the risk of progression/death by 37% versus methotrexate (hazard ratio 0.63; 95% confidence interval 0.48-0.82; P = 0.0005; median 2.9 versus 2.6 months; landmark analysis at 12 and 24 weeks, 58% versus 41%, 21% versus 9%). Improved PFS was complemented by quality of life benefits. Objective response rate was 28% with afatinib and 13% with methotrexate. There was no significant difference in overall survival. The most common grade ≥3 drug-related adverse events were rash/acne (4% with afatinib versus 0% with methotrexate), diarrhoea (4% versus 0%), fatigue (1% versus 5%), anaemia (<1% versus 5%) and leukopenia (0% versus 5%).
CONCLUSIONS


Consistent with the phase III LUX-Head & Neck 1 trial, afatinib significantly improved PFS versus methotrexate, with a manageable safety profile. These results demonstrate the efficacy and feasibility of afatinib as a second-line treatment option for certain patients with recurrent or metastatic HNSCC.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01856478.",2019,"After a median follow-up of 6.4 months, afatinib significantly decreased the risk of progression/death by 37% versus methotrexate (hazard ratio 0.63; 95% confidence interval 0.48-0.82; P = 0.0005; median 2.9 versus 2.6 months; landmark analysis at 12 and 24 weeks, 58% versus 41%, 21% versus 9%).","['certain patients with recurrent or metastatic HNSCC', '340 patients', 'patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) following progression after first-line platinum-based therapy, particularly in Asian countries', 'enrolled Asian patients aged ≥18 years, with histologically or cytologically confirmed recurrent/metastatic HNSCC following first-line platinum-based therapy who were not amenable for salvage surgery or radiotherapy, and had an ECOG performance status of 0/1', 'Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3']","['oral afatinib', 'Afatinib versus methotrexate', 'intravenous methotrexate (40\u2009mg/m2/week), stratified by ECOG performance status and prior EGFR-targeted antibody therapy', 'methotrexate']","['leukopenia', 'diarrhoea', 'progression-free survival (PFS', 'anaemia', 'overall survival', 'Objective response rate', 'risk of progression/death', 'quality of life benefits', 'fatigue']","[{'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0454705', 'cui_str': 'Asian country (geographic location)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",340.0,0.160933,"After a median follow-up of 6.4 months, afatinib significantly decreased the risk of progression/death by 37% versus methotrexate (hazard ratio 0.63; 95% confidence interval 0.48-0.82; P = 0.0005; median 2.9 versus 2.6 months; landmark analysis at 12 and 24 weeks, 58% versus 41%, 21% versus 9%).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Shanghai East Hospital, Tongji University, Shanghai, China. Electronic address: pattrickguo@gmail.com.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory in Translational Oncology, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul.""}, {'ForeName': 'S-B', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bello', 'Affiliation': ""Department of Oncology, St Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Arora', 'Affiliation': 'Department Oncology, Sujan Surgical Cancer Hospital and Amravati Cancer Foundation, Amravati, India.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Science, Beijing.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dechaphunkul', 'Affiliation': 'Division of Medical Oncology, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ""Department of Surgical Oncology, King George's Medical University, Lucknow.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kamble', 'Affiliation': 'Department of Medicine, Government Medical College and Hospital, Nagpur, India.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Hematology and Oncology, First Hospital Affiliated to Jilin University, Jilin, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kandil', 'Affiliation': 'Internal Medicine, Alexandria University Hospital, Alexandria, Egypt.'}, {'ForeName': 'E E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Biostatistics, Boehringer Ingelheim (China) Investment Co., Ltd, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zografos', 'Affiliation': 'Clinical Development and Medical Affairs, Boehringer Ingelheim Ltd, Bracknell, Berkshire, UK.'}, {'ForeName': 'P Z', 'Initials': 'PZ', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz388']
488,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
489,31406974,"Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study.",,2019,,['patients with advanced neuroendocrine tumor and carcinoid syndrome'],"['placebo', 'everolimus plus octreotide LAR']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0024586', 'cui_str': 'Malignant Carcinoid Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}]",[],,0.241099,,"[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Pavel', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baudin', 'Affiliation': ''}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Öberg', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hainsworth', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voi', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rouyrre', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Gross', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz222']
490,31407000,"A randomized, open-label, phase 2 study of everolimus in combination with pasireotide LAR or everolimus alone in advanced, well-differentiated, progressive pancreatic neuroendocrine tumors: COOPERATE-2 trial.",,2019,,"['in advanced, well-differentiated, progressive pancreatic neuroendocrine tumors']",['everolimus in combination with pasireotide LAR or everolimus alone'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0242363', 'cui_str': 'Islet Cell Tumor'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]",[],,0.0185528,,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Kulke', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard-Bohas', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': ''}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'De Herder', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Degtyarev', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bubuteishvili-Pacaud', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voi', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Riechelmann', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz219']
491,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
492,32251254,Using TENS to Enhance Therapeutic Exercise in Individuals with Knee Osteoarthritis.,"Transcutaneous electrical nerve stimulation (TENS) facilitates quadriceps voluntary activation in experimental settings. Augmenting therapeutic exercise (TE) with TENS may enhance the benefits of TE in individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF).
PURPOSE


To determine the effect of TENS+TE on patient-reported function, quadriceps strength and voluntary activation, as well as physical performance compared to sham TENS+TE (Sham), and TE alone in individuals with symptomatic KOA and QVAF.
METHODS


Ninety individuals participated in a double-blinded randomized controlled trial. Everyone received 10 standardized TE sessions of physical therapy. TENS+TE and Sham groups applied the respective devices during all TE sessions and throughout activities of daily living over 4 weeks. The Western Ontario and McMaster University Osteoarthritis Index [WOMAC], quadriceps strength and voluntary activation, as well as a 20-meter walk test, chair-stand test, and stair-climb test were performed at baseline, following the 4-week intervention (Post 1) and at 8 weeks following the start of the intervention (Post 2). Mixed effects models were used to determine between-group differences between baseline and Post 1, as well as baseline and Post 2.
RESULTS


Improvements in WOMAC subscales, quadriceps strength and voluntary activation, 20-meter walk times, chair-stand repetitions, and stair-climb time were found at Post 1 and Post 2 compared to baseline for all groups (p<0.05). WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
CONCLUSIONS


TE effectively improved patient-reported function, quadriceps strength and voluntary activation, as well as physical performance in individuals with symptomatic KOA and QVAF, but augmenting TE with TENS did not improve the benefits of TE.",2020,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","['Ninety individuals participated', 'individuals with symptomatic KOA and QVAF', 'individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF', 'Individuals with Knee Osteoarthritis']","['TENS+TE', 'therapeutic exercise (TE) with TENS', 'Transcutaneous electrical nerve stimulation (TENS', 'TENS', 'sham TENS+TE (Sham), and TE alone', 'Everyone received 10 standardized TE sessions of physical therapy']","['Western Ontario and McMaster University Osteoarthritis Index [WOMAC], quadriceps strength and voluntary activation', 'WOMAC Pain and Stiffness', 'TE effectively improved patient-reported function, quadriceps strength and voluntary activation', 'WOMAC subscales, quadriceps strength and voluntary activation, 20-meter walk times, chair-stand repetitions, and stair-climb time']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}]",90.0,0.054057,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Harkey', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Hope C', 'Initials': 'HC', 'LastName': 'Davis-Wilson', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pfeiffer', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nissman', 'Affiliation': 'Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Jeffery T', 'Initials': 'JT', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002353']
493,31764105,Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.,"OBJECTIVE


To evaluate the association between HIV antiretroviral therapy (ART) and preterm birth (PTB), when defined by gold standard antenatal ultrasound versus newborn exam.
DESIGN


A secondary analysis of the PROMISE 1077BF/1077FF randomized controlled trial, which compared antiretroviral strategies to reduce perinatal HIV transmission and improve maternal health. The trial used newborn exam (i.e. New Ballard Score, NBS) to assess gestational age. This analysis included liveborn singleton pregnancies with both newborn exam and ultrasound data. The primary exposure was the trial's antiretroviral strategies: zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART'). The primary outcome was PTB less than 37 and less than 34 weeks based on the gold standard of ultrasound dating. We evaluated the association between antiretroviral strategy and PTB. We fit multivariable logistic regression models, adjusting for maternal characteristics, obstetric history, and HIV disease severity.
RESULTS


Among 720 assessed pregnant women, PTB less than 37 weeks was 15.4% by NBS and 18.3% by ultrasound. The NBS was specific but not sensitive for PTB less than 37 weeks (92.0% and 48.5%). Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks. These results held for ultrasounds performed less than 24 weeks, and were generally consistent with prior analyses from the PROMISE trial using the NBS.
CONCLUSION


Women starting HIV ART in pregnancy remained at higher risk of PTB when determined by ultrasound, consistent with prior data using newborn exam. However, newborn exam misclassified cases of PTB compared with gold standard ultrasound.",2019,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.",['liveborn singleton pregnancies with both newborn exam and ultrasound data'],"['HIV antiretroviral therapy (ART) and preterm birth (PTB', 'ZDV', ""zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART""]",['perinatal HIV transmission and improve maternal health'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",720.0,0.198607,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.","[{'ForeName': 'Kartik Kailas', 'Initials': 'KK', 'LastName': 'Venkatesh', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Byramiee Jeejeebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}]","AIDS (London, England)",['10.1097/QAD.0000000000002367']
494,31396834,Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis.,"OBJECTIVES


To compare the safety, efficacy, and immunogenicity of MSB11022 (acetate-buffered formulation), an adalimumab biosimilar, with the reference product.
METHOD


AURIEL-RA study was a phase 3, multicenter, randomized, double-blind, parallel group trial (NCT03052322). Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to methotrexate were randomized 1:1 to MSB11022 or reference adalimumab. The primary endpoint was the incidence of treatment-emergent adverse events of special interest (AESIs) (predefined as hypersensitivity) up to week 52. The key secondary endpoint was ACR20 (≥ 20% improvement in American College of Rheumatology core set measurements from baseline) at week 12. Other efficacy endpoints, quality of life, immunogenicity, and pharmacokinetic parameters were evaluated up to week 52. Secondary safety endpoints were evaluated up to week 52 and at a 4-month safety follow-up.
RESULTS


In total, 288 patients were randomized. The proportion of patients experiencing ≥ 1 treatment-emergent AESI up to week 52 was similar between trial arms: 6 patients (4.2%; 95% CI 1.56, 8.91) receiving MSB11022, and 8 patients (5.5%; 95% CI 2.41, 10.58) receiving reference adalimumab. No clinically meaningful differences in efficacy, quality of life, or immunogenicity were seen between treatment arms up to week 52. No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
CONCLUSIONS


These results suggest MSB11022 and reference adalimumab are similar in patients with moderately-to-severely active rheumatoid arthritis in terms of safety, immunogenicity, and efficacy. AURIEL-RA provides evidence to support the similarity of MSB11022 and adalimumab.Key Points• Incidences of hypersensitivity events were similar for MSB11022 (modified buffer) and reference adalimumab.• There was no difference in local reactions between MSB11022 (modified buffer) and reference adalimumab.• AURIEL-RA confirms the equivalence in efficacy and immunogenicity of MSB11022 (modified buffer) and reference adalimumab.",2019,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
","['288 patients were randomized', 'Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to', 'patients with moderately-to-severely active rheumatoid arthritis']","['MSB11022 (acetate-buffered formulation', 'methotrexate', 'MSB11022 or reference adalimumab', 'adalimumab biosimilar MSB11022 (acetate-buffered formulation']","['efficacy endpoints, quality of life, immunogenicity, and pharmacokinetic parameters', 'local reactions', 'incidence of treatment-emergent adverse events of special interest (AESIs) (predefined as hypersensitivity', 'incidence of treatment-emergent adverse events', 'efficacy, quality of life, or immunogenicity', 'ACR20', 'proportion of patients experiencing ≥\u20091 treatment-emergent AESI', 'Incidences of hypersensitivity events', 'safety, efficacy, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0034380'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",288.0,0.0968536,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'NIHR Clinical Research Facility, University of Southampton, Southampton, UK. cedwards@soton.ac.uk.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Monnet', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Vlachos', 'Affiliation': 'Cytel, Geneva, Switzerland.'}, {'ForeName': 'Veranika', 'Initials': 'V', 'LastName': 'Chyrok', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Ghori', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}]",Clinical rheumatology,['10.1007/s10067-019-04679-y']
495,31401791,Exercise training attenuates insulin resistance and improves β-cell function in patients with systemic autoimmune myopathies: a pilot study.,"INTRODUCTION/OBJECTIVES


To assess the effects of exercise training on insulin resistance and β-cell function in patients with systemic autoimmune myopathies (SAMs).
METHOD


This quasi-experimental, prospective study includes 9 patients with SAMs (six with dermatomyositis, two with antisynthetase syndrome, and one with polymyositis). Patients were submitted to a 12-week, twice a week, exercise training program comprising aerobic and resistance exercises. Baseline and after the intervention, we evaluated disease status, aerobic capacity, muscle strength, body composition, insulin resistance, and β-cell function parameters.
RESULTS


The patients have a mean age of 46.7 years and stable disease. No clinical or laboratory parameter impairment was observed after the intervention. Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition. Data from the oral glucose tolerance test showed that exercise did not change glucose area under the curve (AUC), whereas insulin and C-peptide AUC decreased significantly (P < 0.05). Furthermore, Matsuda index and HOMA2 percentage (both surrogates of insulin resistance) also improved (P < 0.05).
CONCLUSION


Exercise training improved aerobic capacity, muscle strength, and muscle function in patients with SAMs. In addition, exercise training led to an attenuation of insulin resistance and improvements in β-cell function parameters. These data indicate that exercise training can mitigate metabolic impairments, attenuating the cardiovascular risk in SAMs.Key Points• Exercise training improved aerobic capacity, muscle strength, and function without disease impairment• Exercise training was capable of improve insulin resistance and β-cell function in patients with SAM• These results suggest that exercise can mitigate metabolic impairments in patients with SAM, attenuating the cardiovascular risk.",2019,"Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition.","['9 patients with SAMs (six with dermatomyositis, two with antisynthetase syndrome, and one with polymyositis', 'patients with systemic autoimmune myopathies (SAMs', 'patients with systemic autoimmune myopathies', 'patients have a mean age of 46.7\xa0years and stable disease', 'patients with SAM •', 'patients with SAM', 'patients with SAMs']","['exercise training', 'Exercise training', 'exercise training program comprising aerobic and resistance exercises']","['change glucose area under the curve (AUC), whereas insulin and C-peptide AUC', 'Furthermore, Matsuda index and HOMA2 percentage', 'cardiovascular risk', 'β-cell function', 'aerobic capacity, muscle strength, and function without disease impairment •', 'disease status, aerobic capacity, muscle strength, body composition, insulin resistance, and β-cell function parameters', 'insulin resistance and β-cell function', 'body composition', 'aerobic capacity, muscle strength, and function', 'β-cell function parameters', 'aerobic capacity, muscle strength, and muscle function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011633', 'cui_str': 'Dermatopolymyositis'}, {'cui': 'C2609059', 'cui_str': 'Antisynthetase syndrome'}, {'cui': 'C0085655', 'cui_str': 'Myositis, Multiple'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C4302167', 'cui_str': 'Autoimmune myopathy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",,0.0142565,"Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition.","[{'ForeName': 'Diego Sales', 'Initials': 'DS', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. diegosales@usp.br.'}, {'ForeName': 'Isabela Bruna Pires', 'Initials': 'IBP', 'LastName': 'Borges', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jean Marcos', 'Initials': 'JM', 'LastName': 'de Souza', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Rosa Maria Rodrigues', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Samuel Katsuyuki', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}]",Clinical rheumatology,['10.1007/s10067-019-04738-4']
496,31410659,Predictors of poor response to urate-lowering therapy in patients with gout and hyperuricemia: a post-hoc analysis of a multicenter randomized trial.,"INTRODUCTION


Clinical guidelines have recommended a target of serum uric acid (SUA) level below 6.0 mg/dL for the urate-lowering therapy (ULT) of gout patients, but there are still a high proportion of patients failing to achieve the therapeutic target above. This study aimed to identify possible predictors of poor response to ULT in gout patients.
METHODS


We performed a post-hoc analysis of a multicenter randomized double-blind trial which assessed the efficacy of febuxostat in patients with hyperuricemia (serum urate level ≥ 8.0 mg/dL) and gout. Demographic characters and baseline data including SUA levels were collected. Poor response to ULT was defined as average SUA after ULT was more than 6.0 mg/dL. Factors associated with poor response to ULT in gout patients were analyzed, and multivariate logistic regression analysis was also carried out to find out those independent predictors.
RESULTS


A total of 370 patients were enrolled in this post-hoc analysis. Compared with those with good response to ULT, patients with poor response to ULT had younger age (P < 0.001), higher proportion of obesity (P = 0.003), higher proportion of statins use (P = 0.019), higher body mass index (BMI) (P < 0.001), higher baseline SUA (P < 0.001), higher proportion of males (P = 0.001), higher alanine transaminase (P < 0.001), higher aspartate transaminase (P = 0.017), higher total cholesterol (P = 0.005), higher triglyceride (P = 0.042), and higher low density lipoprotein (P = 0.037). Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
CONCLUSION


In patients with gout and hyperuricemia, younger age, higher BMI, and higher baseline SUA are predictors of poor response to ULT. These findings could help physicians better identify patients who may fail in ULT and give individualized treatment precisely.
TRIAL REGISTRATION


The trial was registered at chinadrugtrials.org.cn in 2012 (CTR20130172).Key Points• A post-hoc analysis of a multicenter randomized double-blind trial which assessed the efficacy of febuxostat in patients with hyperuricemia and gout was performed.• Multivariate logistic regression analysis showed that younger age, higher BMI, and higher baseline SUA are predictors of poor response to urate-lowering therapy.",2019,"Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
","['patients with gout', 'patients with hyperuricemia and gout was performed', 'patients with gout and hyperuricemia', 'patients with hyperuricemia (serum urate level\u2009≥\u20098.0\xa0mg/dL) and gout', 'gout patients', '370 patients were enrolled in this post-hoc analysis']","['febuxostat', 'ULT', 'urate-lowering therapy']","['higher triglyceride', 'higher baseline SUA', 'low density lipoprotein', 'higher total cholesterol', 'higher BMI', 'higher alanine transaminase', 'higher aspartate transaminase', 'proportion of obesity', 'serum uric acid (SUA) level', 'SUA levels', 'higher body mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",370.0,0.473067,"Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
","[{'ForeName': 'Zepeng', 'Initials': 'Z', 'LastName': 'Mu', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Yangang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Bingfei', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China. qduwangzc@163.com.'}]",Clinical rheumatology,['10.1007/s10067-019-04737-5']
497,30184181,"Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial.","BACKGROUND


Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) present serious reproductive health risks and management challenges, with poor control attributed to survival of treatment-resistant biofilm communities. Boric acid is used in various regimens for non-albicans VVC and recurrent BV. We investigated safety and efficacy of a novel boric acid-based vaginal anti-infective with enhanced antibiofilm activity (TOL-463) in treating BV and VVC.
METHODS


In this phase 2 randomized, investigator-blinded trial conducted at 2 sexual health clinics, women with BV or VVC were randomly assigned (1:1) to 7 nights of TOL-463 vaginal gel or insert. The primary test of cure (TOC) was clinical cure at day 9-12; safety was assessed at TOC and day 21-30.
RESULTS


One hundred six participants (53 with BV, 36 VVC, 17 both) were enrolled; most were African American (69%). Clinical cure rate of BV at TOC was 59% (95% confidence interval [CI], 41%-75%) for TOL-463 insert and 50% (95% CI, 31%-69%) for TOL-463 gel, and for VVC, 92% (95% CI, 67%-99%) for TOL-463 insert and 81% (95% CI, 57%-93%) for TOL-463 gel. Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%).
CONCLUSIONS


TOL-463, especially in vaginal insert form, is effective and safe in treating BV and VVC. Future studies should assess the potential role of TOL-463 as a biofilm disrupter in enhancing likelihood of cure relative to approved therapies, reducing recurrence rates, and combined with traditional antimicrobials.
CLINICAL TRIALS REGISTRATION


NCT02866227.",2019,"Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%).
","['2 sexual health clinics, women with BV or VVC', 'One hundred six participants (53 with BV, 36 VVC, 17 both) were enrolled; most were African American (69', 'Bacterial Vaginosis and Vulvovaginal Candidiasis']","['Novel Vaginal Anti-infective, TOL-463', 'novel boric acid-based vaginal anti-infective with enhanced antibiofilm activity (TOL-463', 'Boric acid', 'TOL-463 vaginal gel or insert']","['safe and well tolerated', 'safety and efficacy', 'Clinical cure rate of BV at TOC', 'Safety and Efficacy', 'cure (TOC']","[{'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0700345', 'cui_str': 'Moniliasis, Vulvovaginal'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0003204', 'cui_str': 'Antiinfective Agents'}, {'cui': 'C0006020', 'cui_str': 'orthoboric acid'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",106.0,0.275265,"Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%).
","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Marrazzo', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Dombrowski', 'Affiliation': 'Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Perlowski', 'Affiliation': 'FHI360, Durham, North Carolina.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pontius', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Dwyn', 'Initials': 'D', 'LastName': 'Dithmer', 'Affiliation': 'Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Schwebke', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy554']
498,32244274,The Effects of SJP-001 on Alcohol Hangover Severity: A Pilot Study.,"BACKGROUND


Despite a clear market need and many hangover products available, currently there is no hangover treatment that is supported by substantial scientific evidence demonstrating its efficacy and safety. A pilot study was conducted to investigate the effects of a potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine) on hangover severity.
METHODS


N  = 13 healthy social drinkers (36.3 ± 8.9 years old) participated in a double-blind, factorial design, cross-over study. On each test day, they consumed their own choice of alcohol up to a self-reported level sufficient to elicit a next-day hangover. Treatments were administered prior to onset of drinking. Next morning, hangover severity was assessed with the Acute Hangover Scale (AHS). Subjects were included in the efficacy analysis only if they reported a hangover after placebo.
RESULTS


N  = 5 subjects (60% male, 35.2 ± 9.0 years old) were included in the analysis. They consumed a mean (SD) of 4.6 ± 1.1 units of alcohol and had an average peak breath alcohol concentration (BrAC) of 0.065% across conditions. Compared to placebo, SJP-001 significantly improved the AHS overall hangover severity score (0.8 ± 0.3 versus 1.5 ± 0.9,  p  = 0.042). Compared to placebo, SJP-001 also reduced scores on the individual item 'hangover', although the observed improvement (-1.6) did not reach statistical significance ( p  = 0.102). The differences from placebo after naproxen alone and fexofenadine alone were not statistically significant. SJP-001 also improved scores for the individual hangover symptoms tired, thirsty, headache, dizziness, nausea, and loss of appetite, but these effects did not reach statistical significance.
DISCUSSION


Compared to placebo, SJP-001 significantly reduced overall hangover severity. The effects of SJP-001 should be further examined in a double-blind, placebo-controlled trial with a larger sample size and controlled administration of sufficient amounts of alcohol to provoke a more substantial alcohol hangover.",2020,"Compared to placebo, SJP-001 also reduced scores on the individual item 'hangover', although the observed improvement (-1.6) did not reach statistical significance ( p  = 0.102).","['N  = 5 subjects (60% male, 35.2 ± 9.0 years old', 'N  = 13 healthy social drinkers (36.3 ± 8.9 years old']","['fexofenadine', 'naproxen', 'SJP-001', 'placebo', 'placebo, SJP-001', 'potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine']","['Alcohol Hangover Severity', 'Acute Hangover Scale (AHS', 'overall hangover severity', 'thirsty, headache, dizziness, nausea, and loss of appetite', 'AHS overall hangover severity score', 'average peak breath alcohol concentration (BrAC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0296800', 'cui_str': 'fexofenadine'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0393756', 'cui_str': 'Hangover'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205710', 'cui_str': 'Progressive sclerosing poliodystrophy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",13.0,0.148212,"Compared to placebo, SJP-001 also reduced scores on the individual item 'hangover', although the observed improvement (-1.6) did not reach statistical significance ( p  = 0.102).","[{'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, 3584CG Utrecht, The Netherlands.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Dahl', 'Affiliation': 'Sen-Jam Pharmaceutical, 223 Wall St., #130, Huntington, NY 11743, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne VIC 3122, Australia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Iversen', 'Affiliation': 'Sen-Jam Pharmaceutical, 223 Wall St., #130, Huntington, NY 11743, USA.'}]",Journal of clinical medicine,['10.3390/jcm9040932']
499,32245308,A Randomized Control Trial Study to Determine the Effect of Melatonin on Serum Levels of IL-1β and TNF-α in Patients with Multiple Sclerosis.,"Multiple sclerosis (MS) is the most common neurological disease that happens at a young age. MS is an inflammatory disease; associated with the demyelination of the central nervous system. Therefore, some inflammatory factors are effective in the mechanism and progression of the disease. Melatonin, as a multi-effect substance including anti-inflammatory effects, can reduce symptoms of MS in patients with a change in their inflammatory factors level. In this study, 50 MS patients who were referred to the MS Society of Markazi Province were randomly selected. All patients were treated with routine MS treatment (interferon) and were divided into control (25 placebo recipients) and treatment (25 recipients of 3 mg melatonin per day for 24 weeks) groups. Anthropometric data of patients including height, weight, and age were determined. Blood samples were collected after fasting in order to determine serum levels of interleukin 1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α). Then, samples were immediately centrifuged for serum separation and sera were transferred to a freezer at -80°C and serum levels of these factors were determined; using ELISA kit. The results of this study showed that there was no significant difference between the control and treatment groups in terms of serum levels of TNF-α. However, the level of IL-1β was significantly reduced in the treatment group compared to the control group, indicating that melatonin decreases this inflammatory substance. Our findings suggest a valuable strategy in the treatment of patients who suffer from MS.",2019,The results of this study showed that there was no significant difference between the control and treatment groups in terms of serum levels of TNF-α.,"['50 MS patients who were referred to the MS Society of Markazi Province', 'patients with a change in their inflammatory factors level', 'patients who suffer from MS', 'Patients with Multiple Sclerosis']","['routine MS treatment (interferon', 'Melatonin', 'melatonin']","['serum levels of TNF-α', 'Serum Levels of IL-1β and TNF-α', 'serum levels of interleukin 1 beta (IL-1β) and tumor necrosis factor-alpha\xa0(TNF-α', 'level of IL-1β', 'inflammatory substance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]",50.0,0.0267085,The results of this study showed that there was no significant difference between the control and treatment groups in terms of serum levels of TNF-α.,"[{'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Yosefifard', 'Affiliation': 'Department of Biology, Damghan Branch, Islamic Azad University, Damghan, Iran. 62yousefifard@gmail.com.'}, {'ForeName': 'Gholamhassan', 'Initials': 'G', 'LastName': 'Vaezi', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran. Gh.vaezi@yahoo.com.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Malekirad', 'Affiliation': 'Department of Biology, Payame Noor University, Tehran, Iran AND Toxicology and Diseases Group, Pharmaceutical Science Research Center, Tehran University of Medical Sciences, Tehran, Iran. malekirad1973@gmail.com.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Faraji', 'Affiliation': 'Department of Neurology, School of Medicine, Arak University of Medical Sciences, Arak, Iran. fardin.faraji@yahoo.com.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Hojati', 'Affiliation': 'Department of Biology, Damghan Branch, Islamic Azad University, Damghan, Iran. vida.hojati@gmail.com.'}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v18i6.2177']
500,31392559,"Effects of coenzyme Q10 supplementation on matrix metalloproteinases and DAS-28 in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.","OBJECTIVES


This study aimed to assess the effect of CoQ10 supplementation on serum matrix metalloproteinases (MMPs) and clinical parameters in rheumatoid arthritis (RA) patients.
METHOD


In this randomized, double-blind, placebo-controlled trial, 54 RA patients who fulfilled the eligibility criteria (18-56 years, diagnosed at least 6 months ago, with DAS-28 > 3.2) were randomly assigned into two groups to receive 100 mg/day CoQ10 (n = 27) or placebo (n = 27) for 2 months. Serum MMP-1 and MMP-3 levels and clinical status using disease activity score in 28 joints (DAS-28) were assessed before and after supplementation. Data were analyzed using χ2, independent sample t test, paired t test, Wilcoxon, Mann-Whitney, and analysis of covariance.
RESULTS


A significant reduction was observed in both CoQ10 and placebo groups in the medians of serum MMP-1 (0.2 to 0.16, P < 0.001), (0.18 to 0.15, P = 0.001); swollen joint count (2 to 0, P < 0.001), (2 to 0, P = 0.009); and the means of DAS-28 (5.01 ± 1.21 to 2.34 ± 0.68, P < 0.001), (4.88 ± 0.96 to 4.04 ± 1.36, P = 0.009) respectively. Serum MMP-3 level increased significantly in placebo group (2.26 to 2.57, P = 0.020), and the MMP-3 changes between groups were significant (P = 0.027). Furthermore, significant reductions were only observed in ESR, pain score, and tender joint count in CoQ10 group compared with baseline (P = 0.001, P < 0.001, and P < 0.001, respectively). Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
CONCLUSIONS


It seems that CoQ10 may provide a new complementary approach for RA patients.Key Points• CoQ10 supplementation in RA patients attenuated serum MMP-3 level.• CoQ10 supplementation in RA patients improved clinical outcomes and ameliorated disease severity.• CoQ10 may provide a new complementary approach for patients with RA.",2019,"Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
","['54 RA patients who fulfilled the eligibility criteria (18-56\xa0years, diagnosed at least 6\xa0months ago, with DAS-28\u2009>\u20093.2', 'patients with RA', 'rheumatoid arthritis (RA) patients', 'patients with rheumatoid arthritis']","['100\xa0mg/day CoQ10', 'placebo', 'CoQ10 supplementation', 'coenzyme Q10 supplementation', 'CoQ10']","['ESR, pain score, and tender joint count', 'swollen joint count', 'clinical outcomes and ameliorated disease severity', 'serum MMP-1', 'MMP-3 changes', 'DAS-28, pain score, and swollen and tender joint count', 'Serum MMP-3 level', 'serum MMP-3 level', 'matrix metalloproteinases and DAS-28', 'Serum MMP-1 and MMP-3 levels and clinical status using disease activity score', 'serum matrix metalloproteinases (MMPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",,0.522653,"Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
","[{'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Beitollah', 'Initials': 'B', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida Malek', 'Initials': 'AM', 'LastName': 'Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mir Amir', 'Initials': 'MA', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Rheumatology, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran. hadi_nut@yahoo.com.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mehnoosh', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Clinical rheumatology,['10.1007/s10067-019-04723-x']
501,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND


Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown.
METHODS


In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS).
RESULTS


From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96).
CONCLUSIONS


Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8']
502,31893488,"Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial.",,2019,,"['advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma']",['Ramucirumab combined with FOLFOX'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],,0.477915,,"[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': ''}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Braiteh', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Firdaus', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Cohn', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Arrowsmith', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': ''}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz454']
503,31929122,EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease.,"BACKGROUND


Gocovri® (amantadine) extended release capsules are approved for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy.
OBJECTIVE


To evaluate the long-term safety, tolerability, and efficacy of Gocovri in patients with PD experiencing levodopa-induced dyskinesia.
METHODS


In this 2-year open-label trial, patients completing double-blind Gocovri clinical trials or excluded from prior trials because of deep-brain stimulation (DBS) received Gocovri 274 mg once daily at bedtime. The primary objective was to evaluate long-term safety and tolerability. In addition, dyskinesia and OFF time were assessed using Part IV (Motor Complications) scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
RESULTS


Among 223 enrolled patients (mean PD duration, 11.7 years; mean levodopa use, 9.3 years), 75.8% completed 1 year of treatment and 57.8% completed the trial, with a median treatment duration of 1.9 years. Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued because of adverse events considered related to study drug. At baseline, MDS-UPDRS Part IV scores were lower for patients continuing Gocovri (mean, 6.5 points) than for previous placebo (9.4) or DBS groups (10.5) but were similar for all groups by week 8 (6.3, 6.2, 6.4, respectively), and remained low for the duration of the trial (at week 100: 6.9, 7.3, 7.0, respectively).
CONCLUSIONS


In patients with PD, Gocovri showed long-term safety and tolerability consistent with double-blind trial findings, and durable reduction in motor complications (dyskinesia and OFF time).",2020,"Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued study drug because of adverse events considered related to study drug.","[""patients with Parkinson's disease (PD) receiving levodopa-based therapy"", 'patients with PD experiencing levodopa-induced dyskinesia', '223 enrolled patients (mean PD duration, 11.7 years; mean levodopa use, 9.3 years), 75.8% completed 1 year of treatment and 57.8% completed the trial, with a median treatment duration of 1.9 years']","['Gocovri® (amantadine', 'Gocovri (Amantadine', 'placebo', 'Gocovri 274\u200amg once daily at bedtime']","['dyskinesia and OFF time', 'MDS-UPDRS Part IV scores', 'constipation', 'peripheral edema', 'long-term safety and tolerability', 'motor complications (dyskinesia and OFF time', ""Part IV (Motor Complications) scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'urinary tract infection', 'evaluate long-term safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}]","[{'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",223.0,0.172543,"Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued study drug because of adverse events considered related to study drug.","[{'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Tanner', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Oertel', 'Affiliation': 'Philipps University, Marburg, Germany.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jankovic', 'Affiliation': ""Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston TX, USA.""}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Chernick', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hubble', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-191841']
504,32250328,"Effects of dynamic core-postural chain stabilization on diaphragm movement, abdominal muscle thickness, and postural control in patients with subacute stroke: A randomized control trial.","BACKGROUND


Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise is effective for improving core stability and postural control in stroke patients.
OBJECTIVE


To compare the effects of DNS and conventional NDT exercises on diaphragm movement, abdominal muscle thickness, and postural control in stroke patients.
METHODS


The participants were randomly allocated into DNS (n = 16) and NDT (n = 15) for 30 minutes each per day, 3 days a week for 4 weeks. Diaphragm movement and abdominal muscle thickness were determined using ultrasonography. The trunk impairment scale (TIS) and Berg Balance Scale (BBS) were used to measure postural control. The functional ambulation category (FAC) was used to evaluate gait ability. Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
RESULTS


ANCOVA revealed the superior effects of DNS in diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests, compared with those of NDT (p < 0.05).
CONCLUSIONS


This novel clinical trial suggests that DNS training was more effective than NDT training in improving postural movement control and gait ability via a balanced co-activation of the diaphragm and TrA/IO in stroke patients.",2020,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","['patients with subacute stroke', 'stroke patients']","['DNS and conventional NDT exercises', 'NDT training', 'dynamic core-postural chain stabilization', 'Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise', 'DNS training', 'DNS', 'NDT']","['functional ambulation category (FAC', 'trunk impairment scale (TIS) and Berg Balance Scale (BBS', 'diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests', 'postural movement control and gait ability', 'diaphragm movement, abdominal muscle thickness, and postural control', 'Diaphragm movement and abdominal muscle thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0224376', 'cui_str': 'Internal Oblique Muscle'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.040415,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","[{'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Joshua Sung Hyun', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-192983']
505,32250330,"Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study.","BACKGROUND


Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
OBJECTIVE


Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
DESIGN


Randomized, double blind, placebo-controlled pilot trial.
SETTING


Inpatient rehabilitation brain injury unit.
PARTICIPANTS


Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
INTERVENTIONS


Transdermal T gel or placebo.
MAIN OUTCOME MEASURES


Revised FIM™ score, strength, adverse events.
RESULTS


Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
CONCLUSIONS


Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.",2020,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","['Inpatient rehabilitation brain injury unit', 'Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into', 'Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation', 'hypogonadal men following TBI in acute rehabilitation', 'hypogonadal men during inpatient rehabilitation following traumatic brain injury']","['Testosterone replacement', 'placebo', 'testosterone (T) therapy', 'Transdermal T gel or placebo', 'Placebo', 'physiologic T therapy']","['FIM™ scores and grip strength', 'Percentage of time with agitation or aggression', 'feasibility, safety, and efficacy', 'absolute functional and strength improvement', 'adverse events', 'FIM™', 'Revised FIM™ score, strength, adverse events', 'rates of recovery']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",70.0,0.707248,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Ripley', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pretz', 'Affiliation': 'Lead Biostatistician, Johnson and Johnson, Irvine, CA, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Weintraub', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Wierman', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, and Rocky Mountain Regional Veterans Affairs Research Service, Aurora, CO, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192992']
506,32249193,Randomized Comparison of Prostatic Artery Embolization versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia.,"PURPOSE


To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification.
RESULTS


Mean Q max  increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001).
CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.",2020,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","['Benign Prostatic Hyperplasia', 'lower urinary symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH', 'men over 60 years of age with LUTS secondary to BPH', 'From November 2014 to January 2017, 45 patients']","['prostatic artery embolization (PAE', 'TURP', 'Prostatic Artery Embolization versus Transurethral Resection', 'transurethral resection of the prostate (TURP', 'PAE']","['changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS', 'QoL improvement', 'mean IPSS reduction', 'adverse events', 'Quality of life (QoL), and prostate volume (PV) changes', 'Adverse events', 'Mean PV reduction', 'Mean Q max']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0429549,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","[{'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Insausti', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: insausti00@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sáez de Ocáriz', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra-Universidad Pública de Navarra, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Pamplona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saioa', 'Initials': 'S', 'LastName': 'Solchaga', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Giral', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Department of Interventional Radiology, Hospital St. Louis, Lisbon, Portugal; Department of Radiology, NOVA Medical School, Lisbon, Portugal; Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Isaacson', 'Affiliation': 'Division of Vascular and Interventional Radiology, Department of Radiology, University of North Carolina Medical Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Urtasun', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saturnino', 'Initials': 'S', 'LastName': 'Napal', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.12.810']
507,31868905,Consensus molecular subgroups (CMS) of colorectal cancer (CRC) and first-line efficacy of FOLFIRI plus cetuximab or bevacizumab in the FIRE3 (AIO KRK-0306) trial.,"BACKGROUND


FIRE-3 compared first-line therapy with FOLFIRI plus either cetuximab or bevacizumab in 592 KRAS exon 2 wild-type metastatic colorectal cancer (mCRC) patients. The consensus molecular subgroups (CMS) are grouping CRC samples according to their gene-signature in four different subtypes. Relevance of CMS for the treatment of mCRC has yet to be defined.
PATIENTS AND METHODS


In this exploratory analysis, patients were grouped according to the previously published tumor CRC-CMSs. Objective response rates (ORR) were compared using chi-square test. Overall survival (OS) and progression-free survival (PFS) times were compared using Kaplan-Meier estimation, log-rank tests. Hazard ratios (HR) were estimated according to the Cox proportional hazard method.
RESULTS


CMS classification could be determined in 438 out of 514 specimens available from the intent-to-treat (ITT) population (n = 592). Frequencies for the remaining 438 samples were as follows: CMS1 (14%), CMS2 (37%), CMS3 (15%), CMS4 (34%). For the 315 RAS wild-type tumors, frequencies were as follows: CMS1 (12%), CMS2 (41%), CMS3 (11%), CMS4 (34%). CMS distribution in right- versus (vs) left-sided primary tumors was as follows: CMS1 (27% versus 11%), CMS2 (28% versus 45%), CMS3 (10% versus 12%), CMS4 (35% versus 32%). Independent of the treatment, CMS was a strong prognostic factor for ORR (P = 0.051), PFS (P < 0.001), and OS (P < 0.001). Within the RAS wild-type population, OS observed in CMS4 significantly favored FOLFIRI cetuximab over FOLFIRI bevacizumab. In CMS3, OS showed a trend in favor of the cetuximab arm, while OS was comparable in CMS1 and CMS2, independent of targeted therapy.
CONCLUSIONS


CMS classification is prognostic for mCRC. Prolonged OS induced by FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab in the FIRE-3 study appears to be driven by CMS3 and CMS4. CMS classification provides deeper insights into the biology to CRC, but at present time has no direct impact on clinical decision-making.The FIRE-3 (AIO KRK-0306) study had been registered at ClinicalTrials.gov: NCT00433927.",2019,"Independent of the treatment, CMS was a strong prognostic factor for ORR (P = 0.051), PFS (P < 0.001), and OS (P < 0.001).",['592 KRAS exon 2 wild-type metastatic colorectal cancer (mCRC) patients'],"['CMS', 'FOLFIRI cetuximab over FOLFIRI bevacizumab', 'cetuximab or bevacizumab', 'bevacizumab', 'FOLFIRI plus cetuximab or bevacizumab']","['Overall survival (OS) and progression-free survival ', 'CMS2', 'CMS distribution', 'PFS', 'CMS4', 'CMS1', 'CMS3', 'Hazard ratios (HR', 'Objective response rates (ORR']","[{'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",514.0,0.0379558,"Independent of the treatment, CMS was a strong prognostic factor for ORR (P = 0.051), PFS (P < 0.001), and OS (P < 0.001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medicine, Division of Hematology, Oncology, and Tumor Immunology (CCM), Charité Universitaetsmedizin Berlin, Berlin, Germany. Electronic address: sebastian.stintzing@charite.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wirapati', 'Affiliation': 'SIB Swiss Institute of Bioinformatics, Bioinformatic Core Facility, Lausanne, Switzerland.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Neureiter', 'Affiliation': 'Institute of Pathology, Paracelsus Medical University/Salzburger Landeskliniken (SALK), Salzburg, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Oncological Practice, Ravensburg.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Medizinische Klinik IV, Klinikum Bayreuth, Bayreuth.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK&K Studien GbR, Landshut.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Al-Batran', 'Affiliation': 'Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt/Main.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Heintges', 'Affiliation': 'Department of Medicine II, Städtisches Klinikum Neuss, Neuss.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lerchenmüller', 'Affiliation': 'Oncological Practice, Münster.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kahl', 'Affiliation': 'Haematology and Oncology, Staedtisches Klinikum Magdeburg, Magdeburg.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Seipelt', 'Affiliation': 'Oncological Practice, Bad Soden.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I & Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology University of Munich, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Pathology University of Munich, Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aderka', 'Affiliation': 'Department of Gastrointestinal Oncology, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology, UZ Leuven, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz387']
508,32244659,A Randomized Controlled Trial Comparing Novel Triple-Cuffed Double-Lumen Endobronchial Tubes with Conventional Double-Lumen Endobronchial Tubes for Lung Isolation.,"Placing a double-lumen endobronchial tube (DLT) in an appropriate position to facilitate lung isolation is essential for thoracic procedures. The novel ANKOR DLT is a DLT developed with three cuffs with a newly added carinal cuff designed to prevent further advancement by being blocked by the carina when the cuff is inflated. In this prospective study, the direction and depth of initial placement of ANKOR DLT were compared with those of conventional DLT. Patients undergoing thoracic surgery ( n  = 190) with one-lung ventilation (OLV) were randomly allocated into either left-sided conventional DLT group ( n  = 95) or left-sided ANKOR DLT group ( n  = 95). The direction and depth of DLT position were compared via fiberoptic bronchoscopy (FOB) after endobronchial intubation between the groups. There was no significant difference in the number of right mainstem endobronchial intubations between the two groups ( p  = 0.468). The difference between the initial depth of DLT placement and the target depth confirmed by FOB was significantly lower in the ANKOR DLT group than in the conventional DLT group (1.8 ± 1.8 vs. 12.9 ± 9.7 mm;  p  < 0.001). In conclusion, the ANKOR DLT facilitated its initial positioning at the optimal depth compared to the conventional DLT.",2020,There was no significant difference in the number of right mainstem endobronchial intubations between the two groups ( p  = 0.468).,['Patients undergoing thoracic surgery ( n  = 190) with one-lung ventilation (OLV'],"['fiberoptic bronchoscopy (FOB', 'left-sided conventional DLT group ( n  = 95) or left-sided ANKOR DLT', 'conventional DLT', 'double-lumen endobronchial tube (DLT', 'Novel Triple-Cuffed Double-Lumen Endobronchial Tubes with Conventional Double-Lumen Endobronchial Tubes']","['number of right mainstem endobronchial intubations', 'initial depth of DLT placement and the target depth confirmed by FOB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0396632', 'cui_str': 'Endobronchial intubation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",190.0,0.0435615,There was no significant difference in the number of right mainstem endobronchial intubations between the two groups ( p  = 0.468).,"[{'ForeName': 'Namo', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Byon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Go Eun', 'Initials': 'GE', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Chungon', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, 21 Namdong-daero 774 beon-gil, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Young Eun', 'Initials': 'YE', 'LastName': 'Joe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Sung Min', 'Initials': 'SM', 'LastName': 'Suh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9040977']
509,32143552,Double-Blinded Prospective Randomized Clinical Trial Comparing Regular and Moses Modes of Holmium Laser Lithotripsy.,"Objective:  To compare regular and Moses modes of holmium laser lithotripsy during ureteroscopy in terms of fragmentation/pulverization and procedural times in addition to perioperative complications.  Patients and Methods:  After obtaining ethics approval, a prospective double-blinded randomized trial was conducted for patients undergoing holmium laser lithotripsy during retrograde ureteroscopy. Patients were randomly assigned to either regular or Moses modes. Patients and surgeons were blinded to the laser mode. Lumenis 120W generator with 200 Moses D/F/L fibers were used. Demographic data, stone parameters, perioperative complications, and success rates were compared. The degree of stone retropulsion was graded on a Likert scale from 0-no retropulsion to 3-maximum retropulsion.  Results:  A total of 72 patients were included in the study (36 per arm). Both groups were comparable in terms of age and preoperative stone size (1.4 cm  vs  1.7 cm,  p  > 0.05). When compared with the regular mode, Moses mode was associated with significantly lower fragmentation/pulverization time (21.1 minutes  vs  14.2 minutes;  p  = 0.03) and procedural time (50.9 minutes  vs  41.1 minutes,  p  = 0.03). However, there were no significant differences in terms of lasing time (7.4 minutes  vs  6.1 minutes,  p  > 0.05) and total energy applied to the stones (11.1 kJ  vs  10.8 kJ,  p  > 0.05). Moses mode was associated with significantly less retropulsion (mean grade was 1.0  vs  0.5,  p  = 0.01). There were no significant differences between both modes in terms of intraoperative complications (11.1%  vs  8.3%,  p  > 0.05), with one patient requiring endoureterotomy for stricture in the Moses group. Success rate at the end of 3 months was comparable between both groups (83.3%  vs  88.4%,  p  > 0.05).  Conclusion:  Moses technology was associated with significantly lower fragmentation/pulverization and procedural times. The reduced fragmentation/pulverization time seen using Moses technology could be explained by the significantly lower retropulsion of stones during laser lithotripsy.",2020,"Moses mode was associated with significantly less retropulsion (mean grade was 1.0 vs. 0.5, p=0.01).","['patients undergoing', 'A total of 72 patients were included in the study (36 per each arm']","['holmium laser lithotripsy during retrograde ureteroscopy', 'Holmium Laser Lithotripsy', 'holmium laser lithotripsy']","['lasing time', 'degree of stone retropulsion', 'Success rate', 'procedural time', 'fragmentation/pulverization time', 'intra-operative complications', 'Demographic data, stone parameters, peri-operative complications and success rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion (finding)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",72.0,0.0732771,"Moses mode was associated with significantly less retropulsion (mean grade was 1.0 vs. 0.5, p=0.01).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Elhilali', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Fahmy', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Carrier', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Sero', 'Initials': 'S', 'LastName': 'Andonian', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}]",Journal of endourology,['10.1089/end.2019.0695']
510,31420812,Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome.,"BACKGROUND


Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the upper extremity. Treatments for CTS alternate from conservative strategies to surgical decompression of median nerve. Few studies have applied platelet-rich plasma (PRP) for treating idiopathic CTS, with acceptable success rates. Further studies are needed to reach concrete conclusion.
OBJECTIVE


To study the effect of PRP injection in treatment of mild to moderate idiopathic CTS.
METHODS


This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate CTS. They were randomly divided into two groups. Group 1: patients received ultrasound guided PRP injection and group 2 patients received ultrasound guided corticosteroid injection. The outcome measures were assessed via Visual Analog Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor functions of median nerve and morphological changes of median nerve detected by ultrasound.
RESULTS


This study included 150 patients suffered from mild to moderate idiopathic CTS 15 did not provide the written consent and 37 participants were excluded from the study based on the exclusion criteria leaving only 98 patients to participate in the study they were divided into two groups PRP Injection Group (PRP-inj-G) - this group included 49 patients (40 females and 9 males) steroid injection Group (St-inj-G) - included 49 patients (41 females and 8 males). At the beginning of study there was no significant difference between both groups in all parameters. (a) PRP injection had significantly improved the clinical manifestations, the electrodiagnostic examination (EDX) parameters of the median nerve (MN), and the median nerve cross sectional area (m-CSA) at 1 month and 3 months post-injection evaluation in comparison to baseline recordings; (b) local steroid injection had significantly improved the clinical manifestations, the EDX parameters of the MN, and the m-CSA at 1 month and 3 months post-injection evaluation in comparison to baseline recordings and (c) PRP injection was superior to the local steroid injection in the improvement of clinical manifestations as well as the MN motor conduction velocity along the wrist-elbow segment, the sensory latency (SL) and the MN sensory conduction, this superiority was observed in third month follow-up suggesting better outcomes in long-term follow-up.
CONCLUSION


Platelet-rich plasma could be effective treatment of mild to moderate idiopathic CTS and superior to corticosteroid in improving pain, function, and distal sensory latency of median nerve.
TRIAL REGISTRATION


Clinical Trials.gov Identifier: NCT03863873Key Points:• PRP is effective treatment of mild to moderate CTS.• PRP is superior to corticosteroids in improving pain and function in CTS.",2019,At the beginning of study there was no significant difference between both groups in all parameters.,"['patients with idiopathic carpal tunnel syndrome', '150 patients suffered from mild to moderate idiopathic CTS 15 did not provide the written consent and 37 participants were excluded from the study based on the exclusion criteria leaving only 98 patients to participate in the study they', 'Egyptian patients suffered from mild to moderate CTS', 'Carpal tunnel syndrome (CTS', 'included 49 patients (40 females and 9 males', 'mild to moderate idiopathic CTS', 'included 49 patients (41 females and 8 males']","['Platelet-rich plasma', 'corticosteroids', 'steroid injection Group (St-inj-G) ', 'PRP', 'PRP Injection Group (PRP-inj-G) - this group', 'PRP injection', 'ultrasound guided PRP injection', 'ultrasound guided corticosteroid injection']","['clinical manifestations, the electrodiagnostic examination (EDX) parameters of the median nerve (MN), and the median nerve cross sectional area (m-CSA', 'pain, function, and distal sensory latency of median nerve', 'sensory latency (SL) and the MN sensory conduction', 'pain and function in CTS', 'via Visual Analog Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor functions of median nerve and morphological changes of median nerve detected by ultrasound']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]",150.0,0.0187617,At the beginning of study there was no significant difference between both groups in all parameters.,"[{'ForeName': 'Mohammad K', 'Initials': 'MK', 'LastName': 'Senna', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Shaat', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt. rehamshaat@mans.edu.eg.'}, {'ForeName': 'Alaa Ali Awad', 'Initials': 'AAA', 'LastName': 'Ali', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt.'}]",Clinical rheumatology,['10.1007/s10067-019-04719-7']
511,31439095,Comparing Multiple Measures of Physical Activity in African-American Adults.,"Objectives:  We assessed the agreement between self-reported and accelerometer-assessed physical activity (PA) in African-American adults by sex, education, income, and weight status.  Methods:  Participants (N = 274) completed the International PA Questionnaire short form (IPAQS), Behavioral Risk Factor Surveillance System (BRFSS) PA questions, and PA Questionnaire (PAQ) and a 7-day accelerometer protocol using a waist-worn ActiGraph GT3X accelerometer. Interrelationships among PA measures were assessed by sociodemographics.  Results:  Participants consistently reported doing ≥150 minutes of moderate-to-vigorous-intensity PA (MVPA) per week via self-report measures and did 113.5±179.4 minutes of accelerometer-assessed MVPA/week. Men self-reported and did more MVPA than women (p < .01). Regardless of sex, there were low correlations between self-report and accelerometer-assessed MVPA (r = .092-.190). Poor agreement existed between self-report and accelerometry for classifying participants as meeting PA recommendations (Cohen κ = .054-.136); only half of the participants were classified the same by both self-report and accelerometry.  Conclusions:  There was generally poor relative agreement between self-report and accelerometer-based assessments of MVPA in this sample of African-American adults. Findings suggest that self-report measures may perform better among African-American women than men, regardless of socioeconomic or weight status.",2019,Poor agreement existed between self-report and accelerometry for classifying participants as meeting PA recommendations (Cohen κ = .054-.136); only half of the participants were classified the same by both self-report and accelerometry.  ,"['African-American adults by sex, education, income, and weight status', 'African-American women than men, regardless of socioeconomic or weight status', 'African-American Adults']",['MVPA'],"['Physical Activity', 'International PA Questionnaire short form (IPAQS), Behavioral Risk Factor Surveillance System (BRFSS) PA questions, and PA Questionnaire (PAQ', 'doing ≥150 minutes of moderate-to-vigorous-intensity PA (MVPA']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1136355', 'cui_str': 'BRFSS'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0132638,Poor agreement existed between self-report and accelerometry for classifying participants as meeting PA recommendations (Cohen κ = .054-.136); only half of the participants were classified the same by both self-report and accelerometry.  ,"[{'ForeName': 'Scherezade K', 'Initials': 'SK', 'LastName': 'Mama', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, The Pennsylvania State University, University Park, PA;, Email: skmama@psu.edu.'}, {'ForeName': 'Nishat', 'Initials': 'N', 'LastName': 'Bhuiyan', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, The Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Lee', 'Affiliation': 'Edson College of Nursing and Health Innovation, Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'Department of Population Health Sciences and the Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""USDA ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",American journal of health behavior,['10.5993/AJHB.43.5.1']
512,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE


To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN


Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS


Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS


In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2  = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
513,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
514,31805973,The impact of basic vs. enhanced Go NAPSACC on child care centers' healthy eating and physical activity practices: protocol for a type 3 hybrid effectiveness-implementation cluster-randomized trial.,"BACKGROUND


To prevent childhood obesity and promote healthy development, health authorities recommend that child care programs use the evidence-based practices that foster healthy eating and physical habits in children. Go NAPSACC is an intervention shown to improve use of these recommended practices, but it is known to encounter barriers that limit its impact and widespread use.
METHODS


This study will use a type 3 hybrid effectiveness-implementation cluster-randomized trial to compare effectiveness and implementation outcomes achieved from Go NAPSACC delivered with a basic or enhanced implementation approach. Participants will include approximately 25 coaches from Child Care Aware of Kentucky (serving four geographic regions), 97 child care centers with a director and teacher from each and two cross-sectional samples of 485 3-4-year-old children (one recruitment at baseline, another at follow-up). Coaches will be randomly assigned to deliver Go NAPSACC using either the basic or enhanced implementation approach. ""Basic Go NAPSACC"" represents the traditional way of delivering Go NAPSACC. ""Enhanced Go NAPSACC"" incorporates preparatory and support activities before and during their Go NAPSACC work, which are guided by the Quality Implementation Framework and the Consolidated Framework for Implementation Research. Data will be collected primarily at baseline and post-intervention, with select measures continuing through 6, 12, and 24 months post-intervention. Guided largely by RE-AIM, outcomes will assess change in centers' use of evidence-based nutrition and physical activity practices (primary, measured via observation); centers' adoption, implementation, and maintenance of the Go NAPSACC program (assessed via website use); center directors', teachers', and coaches' perceptions of contextual factors (assessed via self-report surveys); children's eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking). The hypotheses anticipate that ""Enhanced Go NAPSACC"" will have greater effects than ""Basic Go NAPSACC.""
DISCUSSION


This study incorporates many lessons gleaned from the growing implementation science field, but also offers opportunities to address the field's research priorities, including applying a systematic method to tailor implementation strategies, examining the processes and mechanisms through which implementation strategies produce their effects, and conducting an economic evaluation of implementation strategies.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03938103, Registered April 8, 2019.",2019,"Guided largely by RE-AIM, outcomes will assess change in centers' use of evidence-based nutrition and physical activity practices (primary, measured via observation); centers' adoption, implementation, and maintenance of the Go NAPSACC program (assessed via website use); center directors', teachers', and coaches' perceptions of contextual factors (assessed via self-report surveys); children's eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking).","[""child care centers' healthy eating and physical activity practices"", 'Participants will include approximately 25 coaches from Child Care Aware of Kentucky (serving four geographic regions), 97 child care centers with a director and teacher from each and two cross-sectional samples of 485 3-4-year-old children (one recruitment at baseline, another at follow-up']",['basic vs. enhanced Go NAPSACC'],['eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking'],"[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.104032,"Guided largely by RE-AIM, outcomes will assess change in centers' use of evidence-based nutrition and physical activity practices (primary, measured via observation); centers' adoption, implementation, and maintenance of the Go NAPSACC program (assessed via website use); center directors', teachers', and coaches' perceptions of contextual factors (assessed via self-report surveys); children's eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking).","[{'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC, 27599-7426, USA. avaughn@email.unc.edu.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Studts', 'Affiliation': 'Department of Health, Behavior & Society, College of Public Health, University of Kentucky, 151 Washington Ave, Lexington, KY, 40506-0059, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University, One Brookings Dr., CB 1196, St. Louis, MI, 63130, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ammerman', 'Affiliation': 'Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC, 27599-7426, USA.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Health Policy and Management, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, 135 Dauer Drive, CB 7400, Chapel Hill, NC, 27599-7400, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Curran', 'Affiliation': 'Center for Implementation Research, Division of Health Services Research, Psychiatric Research Institute, University of Arkansas for Medical Sciences, 4301\u2009W. Markham Street, Slot # 577, Little Rock, AR, 72205, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC, 27599-7426, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC, 27599-7426, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC, 27599-7426, USA.'}]",Implementation science : IS,['10.1186/s13012-019-0949-4']
515,32250331,Dose and staffing comparison study of upper limb device-assisted therapy.,"BACKGROUND


Neurological injuries cause persistent upper extremity motor deficits. Device-assisted therapy is an emerging trend in neuro-rehabilitation as it offers high intensity, repetitive practice in a standardized setting.
OBJECTIVE


To investigate the effects of therapy duration and staff-participant configuration on device-assisted upper limb therapy outcomes in individuals with chronic paresis.
METHODS


Forty-seven participants with chronic upper extremity weakness due to neurological injury were assigned to a therapy duration (30 or 60 min) and a staff-participant configuration (1-to-1 or 1-to-2). Therapy consisted of 3 sessions a week for 6 weeks using the Armeo®Spring device. Clinical assessments were performed at three timepoints (Pre, Post, and 3 month Follow up).
RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups. FM improvement was comparable between 30 and 60 min sessions, but participants in the 1-to-2 group had significantly greater improvement in FM from Pre-to-Post and from Pre-to-Follow up than the 1-to-1 group.
CONCLUSIONS


Device-assisted therapy can reduce upper limb impairment to a similar degree whether participants received 30 or 60 min per session. Our results suggest that delivering therapy in a 1-to-2 configuration is a feasible and more effective approach than traditional 1-to-1 staffing.",2020,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","['Forty-seven participants with chronic upper extremity weakness due to neurological injury', 'individuals with chronic paresis']","['Device-assisted therapy', 'upper limb device-assisted therapy']","['FM', 'upper limb impairment', 'Fugl-Meyer score (FM', 'FM improvement']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0446229,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Wuennemann', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Stuart W', 'Initials': 'SW', 'LastName': 'Mackenzie', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Heather Pepper', 'Initials': 'HP', 'LastName': 'Lane', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Avrielle R', 'Initials': 'AR', 'LastName': 'Peltz', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Gerber', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA, USA.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kitago', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192993']
516,32250336,Effects of aerobic training on physical activity in people with stroke: A randomized controlled trial.,"BACKGROUND


Individuals with stroke have low physical activity levels and spend high amount of time in low-energy expenditure activities.
OBJECTIVE


To investigate the effects of aerobic treadmill training on physical activity levels and time spent in low-energy expenditure activities (primary outcomes), as well as on cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke.
METHODS


A randomized controlled trial, with 22 adults with chronic stroke was performed. Experimental group: aerobic treadmill training at 60-80% of heart rate reserve.
CONTROL GROUP


outdoor-overground walking below 40% of heart rate reserve. Both groups: three 40 min sessions/week over 12 weeks. Outcomes were measured at baseline, post-training, and 16-week follow-up.
RESULTS


No changes in the primary outcomes were found for any of the groups. The experimental group showed greater improvements in quality of life at 16-week follow-up (13 points;95% CI:3.5-23). Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk test:55 m;95% CI:3.8-107), and mobility (0.12 m/s;95% CI:0.02-0.2).
CONCLUSION


Aerobic treadmill training improved quality of life. Aerobic treadmill training or outdoor-overground walking improved depression, endurance and mobility. Further studies are needed to clarify the effects of aerobic training on physical activity levels and time spent in low-energy expenditure activities after stroke.",2020,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","['people with stroke', '22 adults with chronic stroke']","['aerobic treadmill training', 'GROUP', 'Aerobic treadmill training', 'aerobic training', 'Aerobic treadmill training or outdoor-overground walking']","['depression, endurance and mobility', 'cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke', 'quality of life', 'physical activity levels and time spent in low-energy expenditure activities', 'mobility', 'depression', 'physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",22.0,0.150659,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","[{'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Nadeau', 'Affiliation': ""École de Réadaptation, Université de Montréal (UdeM), and Centre de recherche interdisciplinaire en réadaptation (CRIR), Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM), CIUSSS Centre-sud-de-l'Ile-de-Montréal, Montréal, Canada.""}, {'ForeName': 'Raquel Rodrigues', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Luci Fuscaldi', 'Initials': 'LF', 'LastName': 'Teixeira-Salmela', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Júlia Caetano', 'Initials': 'JC', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Giane Amorim Ribeiro', 'Initials': 'GAR', 'LastName': 'Samora', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'João Antônio', 'Initials': 'JA', 'LastName': 'da Silva Júnior', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Christina Danielli Coelho de Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}]",NeuroRehabilitation,['10.3233/NRE-193013']
517,32250337,Effects of EMG-triggered FES during trunk pattern in PNF on balance and gait performance in persons with stroke.,"BACKGROUND


EMG-triggered functional electrical stimulation (EMG-triggered FES) is one of the effective method for improving task performance and providing movement re-learning of central nervous system. Proprioceptive neuromuscular facilitation (PNF) is a traditional manual therapy that is used as a method to regain normal movement by providing specific training methods.
OBJECTIVE


The purpose of this study was to investigate the effect of EMG-triggered FES during trunk pattern in PNF on trunk control, balance, and gait of stroke patients.
METHODS


Forty participants were randomly allocated to EMG-triggered FES during PNF trunk pattern group (n = 20) and PNF trunk pattern group (n = 20). This study was a pretest-posttest with a control group design for duration of 4weeks (30 min/5 times/1 week). Outcome measures involved trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI).
RESULTS


In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention. However, there was no significant difference between the two groups in the comparison of the experimental group and the control group according to the amount of change before and after the training.
CONCLUSIONS


The results of this study showed that PNF trunk pattern affected the trunk control for stroke patients, and increased trunk control ability was effective in improving balance and walking. In addition, it was found that the EMG-triggered FES applied to the PNF trunk pattern affected the trunk control.",2020,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","['persons with stroke', 'Forty participants']","['EMG-triggered FES', 'Proprioceptive neuromuscular facilitation (PNF', 'EMG-triggered FES during PNF trunk pattern group (n\u200a=\u200a20) and PNF trunk pattern group', 'EMG-triggered functional electrical stimulation (EMG-triggered FES']","['trunk control ability', 'balance and gait performance', 'trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI', 'TIS, BBS, and DGI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C0475413', 'cui_str': 'Tis category'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0195031,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","[{'ForeName': 'Jaehong', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Department of Physical Therapy, ROI Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, Baekseok University, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Kyongil', 'Initials': 'K', 'LastName': 'Ki', 'Affiliation': 'Department of Physical Therapy, Walkrun Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190944']
518,32250444,A Single-Centre Feasibility Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between a Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings in Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery.,"BACKGROUND


Total hip replacement is recognised as a major risk factor for deep vein thrombosis (DVT). The aim of this study was to investigate the feasibility of using a novel neuromuscular electrical stimulation device (NMES) for DVT prevention in patients recovering from elective hip replacement surgery.
METHODS


Twenty-eight patients undergoing total hip replacement were randomised to receive postoperative treatment with either the NMES device or compression stockings continually from post-surgery until discharge (day 4). The primary outcome measure was the presence of symptomatic or asymptomatic DVT at 48 hours post-surgery and on the day of discharge from hip replacement surgery, as assessed by Duplex ultrasound. Secondary outcomes included hemodynamic responses to the devices, lower limb oedema, sit-to-stand and timed-up-and-go (TUG) scores, and hip range of motion.
RESULTS


In the compression stockings group, two cases of asymptomatic DVT were identified by Duplex ultrasound at 48 hours post-surgery. No cases were found in the NMES group. Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group. In addition, positive hemodynamic effects were found in favour of the NMES group in the non-operated leg. The change in TUG scores also favoured the NMES group (NMES: 150 ± 152%, compression stockings: 363 ± 257% (p=0.03)), whereas no differences in sit-to-stand scores or hip range of motion were observed.
CONCLUSIONS


This study supports the feasibility of NMES as an alternative mechanical prophylaxis worn in the postoperative phase until discharge and provides important findings for clinicians considering novel mechanical prophylaxis options.",2020,"Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group.","['Twenty-eight patients undergoing total hip replacement', 'patients recovering from elective hip replacement surgery', 'Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery']","['NMES device or compression stockings', 'compression stockings', 'Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings', 'novel neuromuscular electrical stimulation device (NMES', 'NMES']","['hemodynamic responses to the devices, lower limb oedema, sit-to-stand and timed-up-and-go (TUG) scores, and hip range of motion', 'leg volume', 'asymptomatic DVT', 'presence of symptomatic or asymptomatic DVT', 'sit-to-stand scores or hip range of motion', 'positive hemodynamic effects', 'TUG scores']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0239340', 'cui_str': 'Edema of lower extremity'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",28.0,0.0724381,"Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group.","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Wainwright', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Burgess', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Middleton', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}]",Surgical technology international,[]
519,32035516,"Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial.","BACKGROUND


The RV144 phase 3 vaccine trial in Thailand demonstrated that ALVAC-HIV (vCP1521) and AIDSVAX B/E administration over 6 months resulted in a 31% efficacy in preventing HIV acquisition. In this trial, we assessed the immunological effect of an additional vaccine boost to the RV144 regimen at varying intervals between the priming vaccine series and the boost.
METHODS


RV306 is a double-blind, placebo-controlled, randomised clinical trial done at three clinical sites in Thailand. Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health. A randomisation schedule was centrally generated with fixed sized strata for Research Institute for Health Sciences Chiang Mai and combined Bangkok clinics. Participants were randomly assigned to one of five groups and then further randomly assigned to either vaccine or placebo. All participants received the primary RV144 vaccine series at months 0, 1, 3, and 6. Group 1 received no additional boost, group 2 received additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo at month 12, group 3 received AIDSVAX B/E alone or placebo at month 12, group 4a received AIDSVAX B/E and ALVAC-HIV or placebo at month 15, and group 4b received AIDSVAX B/E and ALVAC-HIV or placebo at month 18. Primary outcomes were safety and tolerability of these vaccination regimens and cellular and humoral immune responses compared between the RV144 series alone and regimens with late boosts at different timepoints. Safety and tolerability outcomes were assessed by evaluating local and systemic reactogenicity and adverse events in all participants. This trial is registered at ClinicalTrials.gov (NCT01931358); clinical follow-up is now complete.
FINDINGS


Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned active vaccination in group 1, 102 in group 2, 101 in group 3, 52 in group 4a, 51 in group 4b, and 34 combined placebo across all the groups. No vaccine-related serious adverse events were recorded. Occurrence and severity of local and systemic reactogenicity were similar across active groups. Groups with late boosts (groups 2, 3, 4a, and 4b) had increased peak plasma IgG-binding antibody levels against gp70 V1V2 relative to group 1 vaccine recipients with no late boost (gp70 V1V2 92TH023 adjusted p<0·02 for each; gp70 V1V2 CaseA2 adjusted p<0·0001 for each). Boosting at month 12 (groups 2 and 3) did not increase gp120 responses compared with the peak responses after the RV144 priming regimen at month 6; however, boosting at month 15 (group 4a) improved responses to gp120 A244gD- D11 (p=0·0003), and boosting at month 18 (group 4b) improved responses to both gp120 A244gD- D11 (p<0·0001) and gp120 MNgD- D11 (p=0·0016). Plasma IgG responses were significantly lower among vaccine recipients boosted at month 12 (pooled groups 2 + 3) than at month 15 (group 4a; adjusted p<0·0001 for each, except for gp70 V1V2 CaseA2, p=0·0142) and at month 18 (group 4b; all adjusted p<0·001). Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens. CD4 functionality and polyfunctionality scores after stimulation with HIV-1 Env peptides (92TH023) increased with delayed boosting. Groups with late boosts had increased functionality and polyfunctionality scores relative to vaccine recipients with no late boost (all adjusted p<0·05, except for the polyfunctionality score in group 1 vs group 4b, p<0·01).
INTERPRETATION


Taken together, these results suggest that additional boosting of the RV144 regimen with longer intervals between the primary vaccination series and late boost improved immune responses and might improve the efficacy of preventing HIV acquisition.
FUNDING


US National Institute of Allergy and Infectious Diseases and US Department of the Army.",2020,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"['Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health', 'HIV-uninfected Thai volunteers', 'Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned']","['AIDSVAX B/E and ALVAC-HIV or placebo', 'vaccine or placebo', 'placebo', 'additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo', 'AIDSVAX B/E alone or placebo', 'AIDSVAX B/E and ALVAC-HIV', 'MNgD', 'active vaccination']","['CD4 functionality and polyfunctionality scores', 'safety and tolerability of these vaccination regimens and cellular and humoral immune responses', 'peak plasma IgG-binding antibody levels against gp70 V1V2 relative', 'functionality and polyfunctionality scores', 'Plasma IgG responses', 'Occurrence and severity of local and systemic reactogenicity', 'local and systemic reactogenicity and adverse events', 'Safety and tolerability outcomes', 'plasma IgG response']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1155229'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",367.0,0.327131,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"[{'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Nitayaphan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': 'Research Institute for Health Sciences and Faculty of Public Health, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jaranit', 'Initials': 'J', 'LastName': 'Kaewkungwal', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Dhitavat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaluck', 'Initials': 'B', 'LastName': 'Phonrat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Siriwat', 'Initials': 'S', 'LastName': 'Akapirat', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Karasavvas', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Pegu', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Surat', 'Initials': 'S', 'LastName': 'Jongrakthaitae', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA; GlaxoSmithKline, Siena, Italy.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Diazgranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tartaglia', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heger', 'Affiliation': 'US Army Medical Materiel Development Activity, Fort Detrick, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Vasan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. Electronic address: svasan@hivresearch.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30406-0']
520,32246229,Feasibility and Efficacy of the Addition of Heart Rate Variability Biofeedback to a Remote Digital Health Intervention for Depression.,"A rise in the prevalence of depression underscores the need for accessible and effective interventions. The objectives of this study were to determine if the addition of a treatment component showing promise in treating depression, heart rate variability-biofeedback (HRV-B), to our original smartphone-based, 8-week digital intervention was feasible and whether patients in the HRV-B (""enhanced"") intervention were more likely to experience clinically significant improvements in depressive symptoms than patients in our original (""standard"") intervention. We used a quasi-experimental, non-equivalent (matched) groups design to compare changes in symptoms of depression in the enhanced group (n = 48) to historical outcome data from the standard group (n = 48). Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015). Our findings suggest that adding HRV-B to an app-based, smartphone-delivered, remote intervention for depression is feasible and may enhance treatment outcomes.",2020,"Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015).",[],"['HRV-B (""enhanced"") intervention', 'Heart Rate Variability Biofeedback to a Remote Digital Health Intervention']","['treating depression, heart rate variability-biofeedback (HRV-B', 'depressive symptoms', 'depressive symptom score']",[],"[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.101252,"Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015).","[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Economides', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lehrer', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ranta', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Nazander', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Hilgert', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Raevuori', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gevirtz', 'Affiliation': 'Department of Clinical Psychology, California School of Professional Psychology, Alliant University, San Diego, USA.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Khazan', 'Affiliation': 'Harvard Medical School, Boston Center for Health Psychology and Biofeedback, Boston, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Forman-Hoffman', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA. valerie@meruhealth.com.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09458-z']
521,27373900,"Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study.","BACKGROUND


Although the risk of human papillomavirus (HPV) infection is greatest in young women, women older than 25 years remain at risk. We present data from the VIVIANE study of the HPV 16/18 AS04-adjuvanted vaccine in adult women after 7 years of follow-up.
METHODS


In this phase 3, double-blind, randomised controlled trial, healthy women older than 25 years were enrolled (age stratified: 26-35 years, 36-45 years, and ≥46 years). Up to 15% in each age stratum had a history of HPV infection or disease. Women were randomly assigned (1:1) to receive HPV 16/18 vaccine or aluminium hydroxide control, with an internet-based system. The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or greater (CIN1+) associated with HPV 16/18. We did analyses in the according-to-protocol cohort for efficacy and total vaccinated cohort. Data for the combined primary endpoint in the according-to-protocol cohort for efficacy were considered significant when the lower limit of the 96·2% CI around the point estimate was greater than 30%. For all other endpoints and cohorts, data were considered significant when the lower limit of the 96·2% CI was greater than 0%. This study is registered with ClinicalTrials.gov, number NCT00294047.
FINDINGS


The first participant was enrolled on Feb 16, 2006, and the last study visit took place on Jan 29, 2014. 4407 women were in the according-to-protocol cohort for efficacy (n=2209 vaccine, n=2198 control) and 5747 women in the total vaccinated cohort (n=2877 vaccine, n=2870 control). At month 84, in women seronegative for the corresponding HPV type in the according-to-protocol cohort for efficacy, vaccine efficacy against 6-month persistent infection or CIN1+ associated with HPV 16/18 was significant in all age groups combined (90·5%, 96·2% CI 78·6-96·5). Vaccine efficacy against HPV 16/18-related cytological abnormalities (atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion) and CIN1+ was also significant. We also noted significant cross-protective efficacy against 6-month persistent infection with HPV 31 (65·8%, 96·2% CI 24·9-85·8) and HPV 45 (70·7%, 96·2% CI 34·2-88·4). In the total vaccinated cohort, vaccine efficacy against CIN1+ irrespective of HPV was significant (22·9%, 96·2% CI 4·8-37·7). Serious adverse events related to vaccination occurred in five (0·2%) of 2877 women in the vaccine group and eight (0·3%) of 2870 women in the control group.
INTERPRETATION


In women older than 25 years, the HPV 16/18 vaccine continues to protect against infections, cytological abnormalities, and lesions associated with HPV 16/18 and CIN1+ irrespective of HPV type, and infection with non-vaccine types HPV 31 and HPV 45 over 7 years of follow-up.
FUNDING


GlaxoSmithKline Biologicals SA.",2016,"In women older than 25 years, the HPV 16/18 vaccine continues to protect against infections, cytological abnormalities, and lesions associated with HPV 16/18 and CIN1+ irrespective of HPV type, and infection with non-vaccine types HPV 31 and HPV 45 over 7 years of follow-up.
","['The first participant was enrolled on Feb 16, 2006, and the last study visit took place on Jan 29, 2014', 'young women, women older than 25 years remain at risk', 'healthy women older than 25 years were enrolled (age stratified: 26-35 years, 36-45 years, and ≥46 years', 'adult women after 7 years of follow-up', '2877 women in the vaccine group and eight (0·3%) of 2870 women in the control group', '4407 women were in the according-to-protocol cohort for efficacy (n=2209 vaccine, n=2198 control) and 5747 women in the total vaccinated cohort (n=2877 vaccine, n=2870 control', 'women older than 25 years']","['human papillomavirus 16/18 AS04-adjuvanted vaccine', 'HPV 16/18 AS04-adjuvanted vaccine', 'HPV 16/18 vaccine or aluminium hydroxide control, with an internet-based system']","['history of HPV infection or disease', 'vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or greater (CIN1', 'Efficacy, safety, and immunogenicity', 'efficacy, vaccine efficacy against 6-month persistent infection or CIN1']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0349458', 'cui_str': 'Cervical intraepithelial neoplasia grade 1 (disorder)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4407.0,0.276693,"In women older than 25 years, the HPV 16/18 vaccine continues to protect against infections, cytological abnormalities, and lesions associated with HPV 16/18 and CIN1+ irrespective of HPV type, and infection with non-vaccine types HPV 31 and HPV 45 over 7 years of follow-up.
","[{'ForeName': 'Cosette M', 'Initials': 'CM', 'LastName': 'Wheeler', 'Affiliation': 'Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA. Electronic address: Cwheeler@salud.unm.edu.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Skinner', 'Affiliation': ""Vaccines Trials Group, Telethon Kids Institute, Perth, WA, Australia; Sydney University Discipline of Child and Adolescent Health, Children's Hospital Westmead, Sydney, NSW, Australia.""}, {'ForeName': 'M Rowena', 'Initials': 'MR', 'LastName': 'Del Rosario-Raymundo', 'Affiliation': 'Department of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, VIC, Australia; Department of Microbiology, The Royal Children's Hospital, Parkville, VIC, Australia; Murdoch Childrens Research Institute, Parkville, VIC, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, Australia.""}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': ""Department of Pediatrics, University of South Dakota, Sanford School of Medicine, Sanford Children's Specialty Clinic, Sioux Falls, SD, USA.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lazcano-Ponce', 'Affiliation': 'Research Centre on Public Health, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salmerón', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Stapleton', 'Affiliation': 'Departments of Internal Medicine and Infectious Diseases, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Bouchard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Université Laval and Clinique RSF, Québec, QC, Canada.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Martens', 'Affiliation': 'Department of Obstetrics and Gynaecology, Jersey Shore University Medical Center, Neptune, NJ, USA.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Money', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Swee Chong', 'Initials': 'SC', 'LastName': 'Quek', 'Affiliation': 'Parkway Gynaecology Screening and Treatment Centre, Gleneagles Hospital, Singapore, Singapore.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Romanowski', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Vallejos', 'Affiliation': 'Division de Investigacion, Oncosalud-AUNA, Lima, Peru.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Ter Harmsel', 'Affiliation': 'Roosevelt Kliniek, Leiden, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Prilepskaya', 'Affiliation': 'Outpatient Department, Scientific Center of Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Moscow, Russian.'}, {'ForeName': 'Kah Leng', 'Initials': 'KL', 'LastName': 'Fong', 'Affiliation': 'Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Kitchener', 'Affiliation': ""Department of Gynaecological Oncology, Women's Cancer Centre, University of Manchester, St Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Minkina', 'Affiliation': 'City Clinical Hospital, Moscow, Russian.'}, {'ForeName': 'Yong Kuei Timothy', 'Initials': 'YKT', 'LastName': 'Lim', 'Affiliation': ""Department of Gynaecologic Oncology, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Stoney', 'Affiliation': 'Vaccines Trials Group, Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Department of Obstetrics and Gynecology, Miler School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Cruickshank', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Aberdeen, Aberdeen Maternity Hospital, Aberdeen, UK.'}, {'ForeName': 'Alevtina', 'Initials': 'A', 'LastName': 'Savicheva', 'Affiliation': 'Laboratory of Microbiology, DO Ott Research Institute of Obstetrics and Gynecology, St Petersburg, Russia.'}, {'ForeName': 'Daniel Pereira', 'Initials': 'DP', 'LastName': 'da Silva', 'Affiliation': 'Departmento de Ginecologia, Instituto Português de Oncologia de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Murdo', 'Initials': 'M', 'LastName': 'Ferguson', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Colchester Research Group, Colchester Regional Hospital, Dalhousie University, Truro, NS, Canada.'}, {'ForeName': 'Anco C', 'Initials': 'AC', 'LastName': 'Molijn', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Wim G V', 'Initials': 'WGV', 'LastName': 'Quint', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hardt', 'Affiliation': 'GSK Vaccines, Wavre, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Descamps', 'Affiliation': 'GSK Vaccines, Wavre, Belgium.'}, {'ForeName': 'Pemmaraju V', 'Initials': 'PV', 'LastName': 'Suryakiran', 'Affiliation': 'GSK Pharmaceuticals India Ltd, Bangalore, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK Pharmaceuticals India Ltd, Bangalore, India.'}, {'ForeName': 'Brecht', 'Initials': 'B', 'LastName': 'Geeraerts', 'Affiliation': 'GSK Vaccines, Wavre, Belgium.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'GSK Vaccines, King of Prussia, PA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK Vaccines, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(16)30120-7']
522,30909157,Secondary effects of myPlaybook on college athletes' avoidance of drinking games or pregaming as a protective behavior strategy: A multisite randomized controlled study.,"RATIONALE


Student-athletes are at risk for engaging in drinking games and pregaming. Research suggests that brief motivational and alcohol education intervention approaches designed to reduce harmful drinking behaviors may not be effective in lowering students' participation in drinking games or pregaming.
METHOD


We evaluated the effects of myPlaybook (a student-athlete-specific web-based alcohol intervention) on student-athletes' avoidance of drinking games and pregaming over a 4-month period. Seventy-three NCAA member institutions were randomly assigned to the treatment condition or a no-intervention control. Student-athletes at these schools (N = 2449) completed assessments at baseline, 1-, and 4-months post-intervention. At each assessment, participants indicated how often they used each of several harm prevention strategies when they drank in the past month including ""avoided drinking games"" and ""avoided drinking before going out (i.e., pregaming or pre-drinking).""
RESULTS


Controlling for gender and race/ethnicity, treatment condition was not associated with change in avoidance of drinking games and pregaming between baseline and either follow-up. Athletic season did not moderate treatment effects on avoidance of either behavior. We found no evidence that myPlaybook, a general alcohol-reduction intervention, is efficacious in influencing student-athletes' avoidance of drinking games or pregaming as a protective strategy.
CONCLUSIONS


Findings from the present study as well as other research suggest that general alcohol-focused interventions may not have secondary effects on reducing students' participation in drinking games and pregaming and as such, more specific targeted interventions should be investigated.",2019,"We found no evidence that myPlaybook, a general alcohol-reduction intervention, is efficacious in influencing student-athletes' avoidance of drinking games or pregaming as a protective strategy.
","[""student-athletes' avoidance of drinking games and pregaming over a 4-month period"", ""college athletes' avoidance of drinking games or pregaming as a protective behavior strategy"", 'Seventy-three NCAA member institutions']","['no-intervention control', 'myPlaybook (a student-athlete-specific web-based alcohol intervention', 'myPlaybook']","['avoidance of either behavior', 'harmful drinking behaviors', 'avoidance of drinking games']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",,0.0181172,"We found no evidence that myPlaybook, a general alcohol-reduction intervention, is efficacious in influencing student-athletes' avoidance of drinking games or pregaming as a protective strategy.
","[{'ForeName': 'Byron L', 'Initials': 'BL', 'LastName': 'Zamboanga', 'Affiliation': 'Smith College Department of Psychology, 44 College Lane, Bass Hall, Northampton, MA, 01063, USA. Electronic address: bzamboan@smith.edu.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Merrill', 'Affiliation': 'Brown University, USA.'}, {'ForeName': 'Janine V', 'Initials': 'JV', 'LastName': 'Olthuis', 'Affiliation': 'University of New Brunswick, Canada.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Milroy', 'Affiliation': 'University of North Carolina-Greensboro, USA.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Sokolovsky', 'Affiliation': 'Brown University, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wyrick', 'Affiliation': 'University of North Carolina-Greensboro, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.02.016']
523,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
524,32244404,Acupuncture for Relief of Gag Reflex in Patients Undergoing Transoesophageal Echocardiography-A Protocol for a Randomized Placebo-Controlled Trial.,"Background:  Gagging during transesophageal echocardiography examination (TEE) can be distressing and even dangerous for patients. The needling of acupuncture point CV24 was described to be effective in reducing the gag reflex during TEE in patients with ischemic stroke or transient ischemic attack.  Methods:  We describe a proposal for a prospective, randomized, patient, practitioner and assessor-blinded, single-center trial with two arms/groups; real acupuncture will be compared to placebo acupuncture. A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients' selection criteria and receive either indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or placebo needles at the same areas. Patients, the practitioners who will perform the TEE procedure, and the assessor of the outcome measures will be unaware of the group's (real or placebo) allocation.  Results:  The primary outcome is the intensity of gagging, measured using verbal rating scale (VRS-11) from 0 = no gagging to 10 = intolerable gagging. Secondary outcomes include the incidence of gagging, the use of rescue medication, patients' satisfaction with relief of unwanted side effects during TEE procedure, success of patients' blinding (patients' opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry.  Conclusions:  To study the effects of acupuncture against gagging during TEE, we test the needling of acupoints CV24 and PC6 bilaterally. A placebo acupuncture is used for the control group. Trial registration number: NCT NCT0382142.",2020,"Secondary outcomes include the incidence of gagging, the use of rescue medication, patients' satisfaction with relief of unwanted side effects during TEE procedure, success of patients' blinding (patients' opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry.  ","[""A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients' selection criteria and receive either"", 'patients with ischemic stroke or transient ischemic attack', 'Patients Undergoing']","['Transoesophageal Echocardiography-A Protocol', 'Placebo', 'acupuncture', 'Acupuncture', 'placebo acupuncture', 'indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or placebo needles', 'transesophageal echocardiography examination (TEE']","['intensity of gagging, measured using verbal rating scale (VRS-11', ""incidence of gagging, the use of rescue medication, patients' satisfaction with relief of unwanted side effects during TEE procedure, success of patients' blinding (patients' opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry"", 'no gagging to 10 = intolerable gagging']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]","[{'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450833', 'cui_str': 'CV24'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]",60.0,0.541639,"Secondary outcomes include the incidence of gagging, the use of rescue medication, patients' satisfaction with relief of unwanted side effects during TEE procedure, success of patients' blinding (patients' opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry.  ","[{'ForeName': 'Taras I', 'Initials': 'TI', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Müller-Kozarez', 'Affiliation': 'Department of Internal Medicine, University Medicine of Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Knigge', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Raila', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Department of Internal Medicine, University Medicine of Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Busch', 'Affiliation': 'Department of Internal Medicine, University Medicine of Greifswald, 17475 Greifswald, Germany.'}]","Medicines (Basel, Switzerland)",['10.3390/medicines7040017']
525,32114185,Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.,"IMPORTANCE


Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.
DESIGN


2-arm randomized controlled efficacy-effectiveness trial.
SETTING


A large non-profit health maintenance organization.
PARTICIPANTS


165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.
INTERVENTIONS


Two sleep interventions, each 6-7 sessions, both overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).
CONCLUSIONS AND RELEVANCE


If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
TRIAL REGISTRATION


clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.",2020,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","['youth', 'A large non-profit health maintenance organization', '165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider']","['cognitive behavioral therapy', 'overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI', 'SSRI antidepressants']",['depression outcomes'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035168'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",165.0,0.0962211,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Greg.Clarke@kpchr.org.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Sheppler', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Christina.R.Sheppler@kpchr.org.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Firemark', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Alison.J.Firemark@kpchr.org.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Andreea.M.Rawlings@kpchr.org.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: John.F.Dickerson@kpchr.org.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Michael.C.Leo@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105967']
526,32114186,Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial).,"Walking interventions can be effective in increasing physical activity amongst physically inactive employees. However, despite their promising potential regarding sustainability and scalability, peer-led workplace walking interventions have not been tested. We evaluated a peer-led workplace group walking intervention designed to engage physically inactive employees. A 16-week pilot cluster randomized controlled trial consisted of enhanced (5 worksites; n = 50 participants) and minimal treatment (3 worksites; n = 47) conditions. All participants were provided with a Fitbit Zip and information on health benefits of walking. Enhanced treatment participants had access to a mobile phone app incorporating behavior change techniques, were trained on principles of autonomous motivation, and had a peer leader trained in a motivationally supportive communication style. Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only). Outcomes assessed included movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures were taken at baseline and post-intervention. The results supported intervention feasibility. Preliminary efficacy evidence was mixed. Markers of cardio-metabolic risk improved in the enhanced treatment only. Autonomous motivation increased in both conditions. There were no changes in step counts, standing, and sitting time, or well-being. Further fine tuning is needed before a definitive RCT. Australian and New Zealand Clinical Trials Registry: ACTRN12618000807257.",2020,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).",['Australian and New Zealand'],"['enhanced (5 worksites; n\u202f=\u202f50 participants) and minimal treatment (3 worksites; n\u202f=\u202f47) conditions', 'peer-led workplace group walking intervention', 'peer-led motivationally-embellished workplace walking intervention', 'Walking interventions']","['step counts, standing, and sitting time, or well-being', 'Markers of cardio-metabolic risk', 'Autonomous motivation', 'movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures', 'Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043016', 'cui_str': 'Walkers'}]",50.0,0.113263,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia. Electronic address: c.thogersen@curtin.edu.au.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Smith', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'S A M', 'Initials': 'SAM', 'LastName': 'Fenton', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, England.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Centre for Transformative Work Design, Future of Work Institute, Curtin University, Perth, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105969']
527,32184197,A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP).,"Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month ""steps"" with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2-3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253.",2020,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,[],"['LDCT', 'Lung cancer screening with low-dose computed tomography (LDCT', 'community-partnered intervention (Toolkit) designed to support primary care practices', 'community intervention']","['adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs', 'delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings', 'lung cancer mortality']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.158435,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,"[{'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Salazar', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: a.salaza@wustl.edu.'}, {'ForeName': 'Subhjit', 'Initials': 'S', 'LastName': 'Sekhon', 'Affiliation': 'University of Missouri-Kansas City, USA. Electronic address: sks3t4@mail.umkc.edu.'}, {'ForeName': 'Karthik W', 'Initials': 'KW', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: karthik.rohatgi@wustl.edu.'}, {'ForeName': 'Akua', 'Initials': 'A', 'LastName': 'Nuako', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aanuako@wustl.edu.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: esther@wustl.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Harriss', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: courtney.harriss@wustl.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: ellen.brennan@bjc.org.'}, {'ForeName': 'Dareld', 'Initials': 'D', 'LastName': 'LaBeau', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: dareld.labeau@bjc.org.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdalla', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: ibrahim.abdalla@coxhealth.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: chris.schulze@coxhealth.com.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Muenks', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: jackie.muenks@coxhealth.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Overlot', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: daveo@dmhhs.org.'}, {'ForeName': 'Jeri Ann', 'Initials': 'JA', 'LastName': 'Higgins', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: jerih@dmhhs.org.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Regional Cancer Center, Memorial Health System, 701 N 1(st), Springfield, IL 62781, USA. Electronic address: jones.linda@mhsil.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Swick', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: cswick@sblhs.org.'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Goings', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: sgoings@sblhs.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badiu', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: jennifer.badiu@sih.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: Justin.Walker@sih.net.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: colditzg@wustl.edu.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aimeejames@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105991']
528,32184198,The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans.,"Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.",2020,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"['posttraumatic stress disorder', 'Veterans with posttraumatic stress disorder (PTSD', '300 Veterans seeking treatment for clinically significant symptoms of PTSD', 'Veterans']","['written exposure therapy versus imaginal exposure for PTSD', 'written exposure therapy versus imaginal exposure delivered online', 'written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists']",['trauma-related cognitions and emotion regulation'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",300.0,0.026439,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"[{'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA; Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, 401 Quarry Road, Stanford, CA 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gengler', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105990']
529,31721892,"Association of BDNF, HTR2A, TPH1, SLC6A4, and COMT polymorphisms with tDCS and escitalopram efficacy: ancillary analysis of a double-blind, placebo-controlled trial.","OBJECTIVE


We investigated whether single nucleotide polymorphisms (SNPs) associated with neuroplasticity and activity of monoamine neurotransmitters, such as the brain-derived neurotrophic factor (BDNF, rs6265), the serotonin transporter (SLC6A4, rs25531), the tryptophan hydroxylase 1 (TPH1, rs1800532), the 5-hydroxytryptamine receptor 2A (HTR2A, rs6311, rs6313, rs7997012), and the catechol-O-methyltransferase (COMT, rs4680) genes, are associated with efficacy of transcranial direct current stimulation (tDCS) in major depression.
METHODS


Data from the Escitalopram vs. Electrical Current Therapy for Treating Depression Clinical Study (ELECT-TDCS) were used. Participants were antidepressant-free at baseline and presented with an acute, moderate-to-severe unipolar depressive episode. They were randomized to receive escitalopram/tDCS-sham (n=75), tDCS/placebo-pill (n=75), or placebo-pill/sham-tDCS (n=45). General linear models assessed the interaction between treatment group and allele-wise carriers. Additional analyses were performed for each group and each genotype separately.
RESULTS


Pairwise group comparisons (tDCS vs. placebo, tDCS vs. escitalopram, and escitalopram vs. placebo) did not identify alleles associated with depression improvement. In addition, exploratory analyses also did not identify any SNP unequivocally associated with improvement of depression in any treatment group.
CONCLUSION


Larger, combined datasets are necessary to identify candidate genes for tDCS response.",2020,"In addition, exploratory analyses also did not identify any SNP unequivocally associated with improvement of depression in any treatment group.
","['Participants were antidepressant-free at baseline and presented with an acute, moderate-to-severe unipolar depressive episode']","['placebo', 'transcranial direct current stimulation (tDCS', 'Escitalopram vs. Electrical Current Therapy', 'escitalopram/tDCS-sham (n=75), tDCS/placebo-pill (n=75), or placebo-pill/sham-tDCS']",['depression'],"[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.567188,"In addition, exploratory analyses also did not identify any SNP unequivocally associated with improvement of depression in any treatment group.
","[{'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Departamento de Medicina Interna, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Carracedo', 'Affiliation': 'Grupo de Medicina Xenómica/Pharmacogenetics Research, Laboratorio SSL1, Centro Singular de Investigación en Medicina Molecular y Enfermedades Crónicas (CiMUS), Santiago de Compostela, Spain.'}, {'ForeName': 'Olalla M', 'Initials': 'OM', 'LastName': 'Amigo', 'Affiliation': 'Grupo de Medicina Xenómica/Pharmacogenetics Research, Laboratorio SSL1, Centro Singular de Investigación en Medicina Molecular y Enfermedades Crónicas (CiMUS), Santiago de Compostela, Spain.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Pellicer', 'Affiliation': 'Grupo de Medicina Xenómica/Pharmacogenetics Research, Laboratorio SSL1, Centro Singular de Investigación en Medicina Molecular y Enfermedades Crónicas (CiMUS), Santiago de Compostela, Spain.'}, {'ForeName': 'Leda', 'Initials': 'L', 'LastName': 'Talib', 'Affiliation': 'Laboratório de Neurociências (LIM-27) and Instituto Nacional de Biomarcadores em Psiquiatria (INBION), Departamento e Instituto de Psiquiatria, Faculdade de Medicina, São Paulo, SP, Brazil.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto & Centre for Addiction & Mental Health (CAMH), Toronto, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Departamento de Medicina Interna, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Departamento de Medicina Interna, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratório de Neurociências (LIM-27) and Instituto Nacional de Biomarcadores em Psiquiatria (INBION), Departamento e Instituto de Psiquiatria, Faculdade de Medicina, São Paulo, SP, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Cappi', 'Affiliation': 'Programa Transtornos do Espectro Obsessivo-Compulsivo, Departamento e Instituto de Psiquiatria, Faculdade de Medicina, USP, São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0620']
530,32037592,A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study.,"Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis. There are currently limited data available to determine how often it is possible to improve an angiographically acceptable but physiologically suboptimal result. A physiology-guided optimization strategy can achieve a clinically meaningful increase in the proportion of patients achieving a final post-PCI FFR ≥0.90 compared to standard care. Following angiographically successful PCI procedures, 260 patients will be randomized (1:1) to receive either a physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group). Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization. The primary endpoint is defined as the proportion of patients with a final post-PCI FFR result ≥0.90. Secondary endpoints include change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization) at 3 months and 1 year. 260 individual patients were successfully randomized between March 2018 and November 2019. Key baseline demographics of the study population are reported within. TARGET FFR is an investigator-initiated, prospective, single-center, randomized controlled trial of an FFR-guided PCI optimization strategy. The study has completed recruitment and is now in clinical follow-up. It is anticipated that primary results will be presented in Autumn 2020. ClinicalTrials.gov Identifier: NCT03259815. [Correction added on Apr 3 2020, after first online publication: Clinical Trials identifier added.].",2020,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"['260 patients', ""Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization"", '260 individual patients were successfully randomized between March 2018 and November 2019']","['physiology-guided percutaneous coronary intervention', 'FFR', 'physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group']","['proportion of patients with a final post-PCI FFR result ≥0.90', 'change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",260.0,0.129999,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}]",Clinical cardiology,['10.1002/clc.23342']
531,32242806,Spinal mobility in the cervical and lumbar spine correlates with magnetic resonance imaging findings for inflammatory and structural changes in patients with active ankylosing spondylitis.,"OBJECTIVES


We aimed to assess relationships between single Bath Ankylosing Spondylitis Metrology Index (BASMI) components and corresponding spinal segment magnetic resonance images (MRI) in anti-tumour-necrosis-factor-treated AS patients.
METHODS


Using available MRI and BASMI data from the GO-RAISE trial (n=91 patients), MRI scores for active inflammatory (ASspiMRI-a) and chronic structural (ASspiMRI-c) changes in cervical and lumbar spine segments were compared with BASMI cervical (cervical-rotation [CR] angle, tragus-to-wall [TTW] distance) and lumbar (lumbar flexion [LF], lateral-lumbar-flexion [LLF]) spine component scores (linear definition). Generalised linear models were employed to assess relationships between BASMI components and ASspiMRI-a/ASspiMRI-c measurements at baseline and for week-14 (golimumab/placebo groups) and week-104 (all golimumab-treated) change scores.
RESULTS


Baseline lumbar ASspiMRI-a scores correlated with LF and LLF (β=0.231 and 0.238, respectively; both p<0.01), while this was less prominent for ASspiMRI-c scores and LLF (β=0.142, p=0.04). A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
CONCLUSIONS


Detailed assessments indicated baseline spinal mobility impairment in patients with active AS correlated weakly with MRI-detected lumbar spinal inflammation; correlations with chronic, structural damage/changes were very weak. Improved, less variable MRI and spinal metrology assessments are needed for future clinical research.",2020,"A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
",['patients with active ankylosing spondylitis'],"['single Bath Ankylosing Spondylitis Metrology Index (BASMI) components and corresponding spinal segment magnetic resonance images (MRI', 'magnetic resonance imaging']","['baseline spinal mobility impairment', 'cervical spine ASspiMRI-c score and TTW distance', 'MRI scores for active inflammatory (ASspiMRI-a) and chronic structural (ASspiMRI-c) changes in cervical and lumbar spine segments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",91.0,0.0600284,"A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
","[{'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany. xenofon.baraliakos@elisabethgruppe.de.'}, {'ForeName': 'Kay-Geert A', 'Initials': 'KA', 'LastName': 'Hermann', 'Affiliation': 'Radiology, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany.'}]",Clinical and experimental rheumatology,[]
532,32236553,A randomized trial comparing the effects of sternal band and plate fixation of the sternum with that of figure-of-8 wires on sternal edge motion and quality of recovery after cardiac surgery.,"OBJECTIVES


We sought to compare the effects of conventional wire cerclage with that of the band and plate fixation of the sternum.
METHODS


A parallel randomized open-label trial with 1:1 allocation ratio compared healing after adult cardiac surgery using 'figure-of-8' stainless steel wire cerclage or a band and plate system (plates). The primary end point was maximal sternal edge displacement during active coughing of ≥2 mm in ≥2 of 4 sites measured with ultrasound by 2 assessors blinded to the other at 6 weeks postoperatively. Secondary end points at 12 weeks included ultrasound assessment, computed tomography (CT) scan and multidimensional assessment of quality of recovery using the Postoperative Quality of Recovery Scale.
RESULTS


Of 50 patients, 26 received plates and 24 wires. Two patients died and 1 withdrew consent leaving 25 plates and 22 wires for primary end point analysis. Operations included 37 coronary, 5 valve and 8 combined coronary and valve procedures. At 6 weeks, less sternal movement was observed in patients with plates than those with wires, 4% (1/25) vs 32% (7/22), P = 0.018. Agreement between observers was high, kappa = 0.850. At 12 weeks, less ultrasound motion was seen in patients with plates, 0% (0/23) than those with wires, 25% (5/20), P = 0.014. Recovery from pain was higher for patients with plates 92% (22/24) than those with wires 67% (14/21), P = 0.004. CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036. CT mild bone synthesis or greater was similar between patients with plates 21% (5/24) and wires 14% (3/21), P = 0.71.
CONCLUSIONS


Patients receiving the band and plate system had significantly less sternal edge motion than those receiving wires, 6 and 12 weeks after cardiac surgery and experienced less pain.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov NCT03282578.",2020,"CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036.","['Of 50 patients, 26 received plates and 24 wires', 'Operations included 37 coronary, 5 valve and 8 combined coronary and valve procedures']","[""1:1 allocation ratio compared healing after adult cardiac surgery using 'figure-of-8' stainless steel wire cerclage or a band and plate system (plates"", 'conventional wire cerclage', 'sternal band and plate fixation']","['maximal sternal edge displacement during active coughing of ≥2\u2009mm in ≥2 of 4 sites measured with ultrasound', 'ultrasound assessment, computed tomography (CT) scan and multidimensional assessment of quality of recovery using the Postoperative Quality of Recovery Scale', 'sternal movement', 'ultrasound motion', 'CT bone edge separation', 'CT mild bone synthesis', 'pain', 'sternal edge motion', 'sternal edge motion and quality of recovery', 'Recovery from pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0230715', 'cui_str': 'A band'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0795619,"CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036.","[{'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Doa', 'Initials': 'D', 'LastName': 'El-Ansary', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hoang', 'Affiliation': 'Department of Surgery, The Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lui', 'Affiliation': 'Department of Radiology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McCusker', 'Affiliation': 'Department of Radiology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Tivendale', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Canty', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Colin F', 'Initials': 'CF', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa040']
533,32087336,Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.,"BACKGROUND


Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.
METHODS/DESIGN


78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.
DISCUSSION


This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02451670.",2020,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"['patients with SMI', '10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit', 'Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal', 'people with serious mental illness', 'people with serious mental illness (SMI', '78 Midwestern primary care clinics']",['clinical decision support (CDS) tool'],"['CV risk', 'total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",10347.0,0.266181,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Rossom', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America. Electronic address: rebecca.c.rossom@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waring', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ohnsorg', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Allise', 'Initials': 'A', 'LastName': 'Taran', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kopski', 'Affiliation': 'HealthPartners Medical Group, Minneapolis, MN, United States of America.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105964']
534,32087338,The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.,"Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.",2020,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"['Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity', 'individuals with prediabetes', 'Medicaid managed care adults in New York State', 'Medicaid managed care adults in New York state']","['Diabetes Prevention Program (DPP', 'DPP with various incentive strategies based on class attendance and weight loss as follows']","['weight-loss milestone', 'Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss']","[{'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0283401,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"[{'ForeName': 'Jo-Yu', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: Jo-Yu.Chin@health.ny.gov.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Matson', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: jacqueline.matson@health.ny.gov.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: susan.mccauley@health.ny.gov.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anarella', 'Affiliation': 'Albany, NY, USA. Electronic address: joeanarella@gmail.com.'}, {'ForeName': 'Foster', 'Initials': 'F', 'LastName': 'Gesten', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: fgesten@nycap.rr.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roohan', 'Affiliation': 'MVP Health Care, Schenectady, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105960']
535,32087339,"Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.","Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.",2020,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","['anxiety disorders', 'individuals with diagnosed anxiety disorders']","['Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program', 'anxiety: Mindfulness meditation versus escitalopram (TAME', 'pharmacotherapy with escitalopram or MBSR']","['Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia', 'key symptom and function measures, as well as tolerability and satisfaction with treatment']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0150277'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0287433,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA. Electronic address: eah103@georgetown.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mihriye', 'Initials': 'M', 'LastName': 'Mete', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA; MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Dutton', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105965']
536,31359368,Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial.,"INTRODUCTION


iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received < 60 units/day.
METHODS


Outcomes were compared for participants receiving 60 or < 60 units/day at week 30. Endpoints analyzed included change in A1C, fasting plasma glucose (FPG), 2-h postprandial glucose (2-h PPG), body weight, proportion of participants achieving A1C < 7.0%, proportion of participants receiving rescue therapy, documented symptomatic hypoglycemia, and gastrointestinal adverse event (GI AE) incidence.
RESULTS


By week 30, 27% (iGlarLixi) and 31% (iGlar) of participants received the maximum dose. Participants on 60 vs. < 60 units/day were younger and had higher body weight, body mass index (BMI), FPG, and baseline insulin dose. In both dose groups, A1C change from baseline was significantly greater with iGlarLixi vs. iGlar, and more participants treated with iGlarLixi vs. iGlar achieved A1C < 7.0%. No significant differences were observed in change from baseline for A1C, FPG, 2-h PPG, or GI AE incidence between insulin dose groups, regardless of treatment. In both treatment arms, incidence of symptomatic hypoglycemia was lower in participants receiving 60 units/day vs. those receiving < 60 units/day. Participants treated with iGlarLixi (< 60 or 60 units/day) had modest weight loss over 30 weeks vs. an increase in weight compared with iGlar.
CONCLUSIONS


Maximum doses of iGlarLixi were required in participants with a more insulin-resistant clinical phenotype (younger, higher BMI, FPG, and insulin doses). Benefits were observed with iGlarLixi vs. iGlar, even at 60 units/day, with more participants achieving glycemic goals, no increase in symptomatic hypoglycemia, and a modest reduction in body weight.
FUNDING


Sanofi US, Inc.",2019,"No significant differences were observed in change from baseline for A1C, FPG, 2-h PPG, or GI AE","['Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial', 'participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received', 'participants receiving 60 or\u2009<\u200960 units/day at week 30', 'Participants on 60 vs.\u2009<\u200960 units/day were younger and had', 'patients with type 2 diabetes']","['insulin glargine', 'iGlarLixi', 'glucagon-like peptide-1 receptor agonist lixisenatide']","['change in A1C, fasting plasma glucose (FPG), 2-h postprandial glucose (2-h PPG), body weight, proportion of participants achieving A1C\u2009<\u20097.0%, proportion of participants receiving rescue therapy, documented symptomatic hypoglycemia, and gastrointestinal adverse event (GI AE) incidence', 'incidence of symptomatic hypoglycemia', 'A1C, FPG, 2-h PPG, or GI AE', 'A1C change', 'modest weight loss', 'glycemic goals', 'symptomatic hypoglycemia', 'higher body weight, body mass index (BMI), FPG, and baseline insulin dose', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4293375', 'cui_str': 'Insulin Glargine / Lixisenatide'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456683', 'cui_str': 'unit/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.204393,"No significant differences were observed in change from baseline for A1C, FPG, 2-h PPG, or GI AE","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center, New Orleans, LA, USA. lblonde@ochsner.org.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Inc., Escondido, CA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Xinyi, Inc., Bridgewater, NJ, USA.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Dex', 'Affiliation': 'Sanofi US, Inc., Bridgewater, NJ, USA.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Luigi F', 'Initials': 'LF', 'LastName': 'Meneghini', 'Affiliation': 'UT Southwestern Medical Center and Parkland Health and Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': 'Sanofi US, Inc., Bridgewater, NJ, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}]",Advances in therapy,['10.1007/s12325-019-01033-1']
537,31764746,Urinary Placental Growth Factor for Prediction of Placental Adverse Outcomes in High-Risk Pregnancies.,"OBJECTIVE


To evaluate whether urinary levels of placental growth factor (PlGF) during pregnancy are associated with the subsequent development of composite adverse outcomes (preeclampsia, fetal growth restriction, placental abruption, perinatal death, maternal death) occurring at less than 34 weeks of gestation.
METHODS


This is a preplanned ancillary study of the Heparin-Preeclampsia trial, a randomized trial in pregnant women with a history of severe early-onset preeclampsia (less than 34 weeks of gestation). In the parent study, all women were treated with aspirin and then randomized to receive either low-molecular-weight (LMW) heparin or aspirin alone. For this substudy we measured urinary levels of PlGF and urinary creatinine at the following gestational windows: 10-13 6/7, 14-17 6/7, 18-21 6/7, 22-25 6/7, 26-29 6/7, 30-33 6/7, and 34-37 6/7 weeks of gestation.
RESULTS


Urine samples were available from 187 patients: LMW heparin plus aspirin (n=93) and aspirin alone (n=94). The two groups had comparable baseline characteristics and had similar adverse composite outcomes at less than 34 weeks of gestation (14/93 [15.1%] vs 11/94 [11.7%]; P=.50). There were no significant differences in urine PlGF levels in the patients who received LMW heparin plus aspirin compared with those who received aspirin alone. However, median [interquartile range] urinary PlGF/creatinine concentrations (pg/mg) measured at mid-pregnancy (22-26 weeks of gestation) were significantly lower among women who developed composite adverse outcome at less than 34 weeks of gestation (42.7 [32.4-80.8] vs 255.6 [118.7-391.8] P<.001) and significantly lower among women who developed preeclampsia at less than 34 weeks of gestation (42.7 [27.5-80.7] vs 244.6 [112.9-390.6] P<.001). For a fixed false-positive rate of 10% the sensitivity of urinary PlGF concentrations at mid-pregnancy was 75.2% (area under the curve 0.93) for the subsequent development of composite adverse outcomes.
CONCLUSION


Decreased urinary PlGF at mid-gestation (22-26 weeks of gestation) is associated with the subsequent development of preeclampsia-related adverse outcomes at less than 34 weeks of gestation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT00986765.",2019,There were no significant differences in urine PlGF levels in the patients who received LMW heparin plus aspirin compared with those who received aspirin alone.,"['187 patients', 'pregnant women with a history of severe early-onset preeclampsia (less than 34 weeks of gestation', 'High-Risk Pregnancies']","['Heparin', 'low-molecular-weight (LMW) heparin or aspirin alone', 'aspirin alone', 'aspirin', 'LMW heparin plus aspirin']","['urinary PlGF', 'urinary levels of placental growth factor (PlGF', 'preeclampsia', 'urine PlGF levels', 'sensitivity of urinary PlGF concentrations', 'composite adverse outcomes (preeclampsia, fetal growth restriction, placental abruption, perinatal death, maternal death', 'adverse composite outcomes', 'median [interquartile range] urinary PlGF/creatinine concentrations', 'urinary levels of PlGF and urinary creatinine']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0242786', 'cui_str': 'High-Risk Pregnancy'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0000832', 'cui_str': 'Placental Abruption'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",187.0,0.380565,There were no significant differences in urine PlGF levels in the patients who received LMW heparin plus aspirin compared with those who received aspirin alone.,"[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Lecarpentier', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, the Department of Obstetrics-Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, Créteil, the Department of Hematology, University Hospital Caremeau, Nîmes, Faculty of Pharmaceutical and Biological Sciences, University of Montpellier, Montpellier, and the Center of Biological Resources, Centre Hospitalier Inter-Communal de Créteil, France; and the Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Gris', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Cochery-Nouvellon', 'Affiliation': ''}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': ''}, {'ForeName': 'Houria', 'Initials': 'H', 'LastName': 'Abbas', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': ''}, {'ForeName': 'Subbian Ananth', 'Initials': 'SA', 'LastName': 'Karumanchi', 'Affiliation': ''}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Haddad', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003547']
538,32150651,Pre- and postnatal Lactobacillus reuteri treatment alters DNA methylation of infant T helper cells.,"BACKGROUND


Perinatal childhood exposures, including probiotic supplementation, may affect epigenetic modifications and impact on immune maturation and allergy development. The aim of this study was to assess the effects of pre- and postnatal Lactobacillus reuteri supplementation on DNA methylation in relation to immune maturation and allergy development.
METHODS


DNA methylation patterns were investigated for allergy-related T helper subsets using a locus-specific method and at a genome-wide scale using the Illumina 450K array. From a randomised, double-blind, placebo-controlled allergy prevention trial with pre- and postnatal probiotic supplementation, CD4+ T helper cells were obtained at birth (from cord blood), and 12 and 24 months of age (total (placebo/probiotics); locus-specific method: CB = 32 (17/15), 12 months = 24 (9/15), 24 months = 35 (15/20); Illumina: CB = 19 (10/9), 12 months = 10 (6/4), 24 months = 19(11/8)).
RESULTS


Comparing probiotics to placebo, the greatest genome-wide differential DNA methylation was observed at birth, where the majority of sites were hypomethylated, indicating transcriptional accessibility in the probiotic group. Bioinformatic analyses, including network analyses, revealed a module containing 91 genes, enriched for immune-related pathways such as chemotaxis, PI3K-Akt, MAPK and TGF-β signalling. A majority of the module genes were associated with atopic manifestations (OR = 1.43, P = 2.4 × 10 -6  ), and a classifier built on this model could predict allergy development (AUC = 0.78, P = 3.0 × 10 e-3  ). Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared with later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
CONCLUSION


Maternal L. reuteri supplementation during pregnancy alters DNA methylation patterns in CD4+ T cells towards enhanced immune activation at birth, which may affect immune maturation and allergy development.",2020,"Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared to later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
",['DNA methylation patterns were investigated for allergy-related T helper subsets using a locus-specific method and at a genome-wide scale using the Illumina 450K array'],"['Maternal L. reuteri supplementation', 'placebo', 'Pre- and postnatal Lactobacillus reuteri treatment', 'pre-and postnatal Lactobacillus reuteri supplementation', 'pre- and postnatal probiotic supplementation, CD4+ T helper cells']","['greatest genome-wide differential DNA methylation', 'DNA methylation of infant T helper cells', 'atopic manifestations']","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0222045'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}]",450.0,0.152078,"Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared to later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Huoman', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Söderholm', 'Affiliation': 'Division of Molecular Medicine and Virology, Department of Biomedical and Clinical Sciences, Wallenberg Centre for Molecular Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ratnesh', 'Initials': 'R', 'LastName': 'Bhai Mehta', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Allergy Center, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Abrahamsson', 'Affiliation': ""Crown Princess Victoria's Child and Youth Hospital, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Physics, Chemistry and Biology, Bioinformatics, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13240']
539,32238795,Longitudinal effects of a nurse-managed comprehensive cardiovascular disease prevention program for hospitalized coronary heart disease patients and primary care high-risk patients.,"BACKGROUND


The EUROACTION study (nurse‑coordinated multidisciplinary, family‑based cardiovascular disease prevention program) documented the efficacy of a nurse‑managed, comprehensive prevention program in reducing risk factors for cardiovascular disease (CVD). No information was available on survival.
AIMS


The aim of the study was to assess the effects of EUROACTION intervention on CVD risk factors and 12‑year survival in the Polish component of the study.
METHODS


Two district hospitals and 2 primary care practices were allocated randomly to intervention (INT) or usual care (UC). The primary endpoints were lifestyle and risk factors changes at 1‑year follow‑up. Differences in survival were analyzed using the multivariable Cox proportional hazards regression models.
RESULTS


The study involved 628 patients with coronary heart disease (CHD) and 711 high‑risk patients. Compared to UC, INT patients achieved healthier lifestyles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after the intervention. Less deaths occurred in patients from the INT hospital and from INT primary practice (hazard ratio [HR], 0.58; 95% CI, 0.42-0.82 and HR, 0.53; 95% CI, 0.3-0.95, respectively). Adjustment for the covariates slightly attenuated the estimates and removed significance (HR, 0.74; 95% CI, 0.52-1.04 and HR, 0.66; 95% CI, 0.36-1.24, respectively). For combined CHD and high‑risk patient groups, compared with UC, INT patients had a 36% lower risk of death after adjustment for age, sex, and history of CHD (HR, 0.64; 95% CI, 0.48-0.86).
CONCLUSIONS


The impact of the EUROACTION intervention on lifestyle and CVD risk factors could have contributed to lower mortality in INT coronary and high‑risk patients. These results emphasize the need for sustaining the interventions to help patients maintain a healthy lifestyle.",2020,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","['Two district hospitals and two primary practices', '628 CHD patients and 601 high-risk patients', 'hospitalized coronary heart disease patients and primary care high-risk patients']","['nurse managed, comprehensive prevention programme', 'nurse-managed comprehensive cardiovascular disease prevention programme', 'intervention (INT) or usual care (UC']","['survival', 'healthier life styles', 'Less deaths', 'CVD risk factors', 'risk factors', 'lifestyle and risk factors changes at 1 year observation', 'risk of death']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",628.0,0.0552067,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pająk', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolfshaut-Wolak', 'Affiliation': ''}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Doryńska', 'Affiliation': ''}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Jankowski', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fornal', 'Affiliation': ''}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': ''}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': ''}, {'ForeName': 'Kalina', 'Initials': 'K', 'LastName': 'Kawecka-Jaszcz', 'Affiliation': ''}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Kotseva', 'Affiliation': ''}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Pająk', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15273']
540,32245305,"Value and Safety of High Flow Oxygenation in the Treatment of Inpatient Asthma: A Randomized, Double-blind, Pilot Study.","This study was aimed to compare the value and safety of high-flow nasal cannula (HFNC) and conventional oxygen therapy (COT) in patients with asthma exacerbation. In this randomized double-blind study, forthy patients with moderate-to-severe asthma exacerbations, aged 18 years or older were enrolled. Patients were randomly assigned to receive either HFNC or COT for 24 hours. Dyspnea scale, O2 saturation, spirometer indexes, respiratory and heart rate, and arterial blood gas (ABG) were compared within 2 and 24 hours of intervention. Dyspnea scale decreased significantly from 7.58±1.04 to 6.45±0.51 (p=0.000), and from 7.84±1.7 to 6.89±0.9 (p=0.049) within 2 hours in HFNC and COT groups, respectively. In the HFNC group, forced expiratory volume in one second (FEV1) was 1.48 ±0.94 L at the time of admission and increased to 1.61±0.66 L (p=0.19) and 1.82±0.92 L (p=0.003) after 2 and 24 hours of experience, respectively. In addition, in the COT group, FEV1 increased from 1.43±0.65 L to 1.46±0.53 L and 1.64±0.6 L in the respective time-points, (p=0.071, 0.079). PaO2 and O2 saturation increased significantly in both groups during the first 2 hours. Two patients in the HFNC group had the complaint of nasal irritation and the device-produced heat; while one patient in the COT group needed more respiratory care. HFNC could be a therapeutic option for asthma exacerbation among adult patients after considering the patient's selection.",2019,"Dyspnea scale decreased significantly from 7.58±1.04 to 6.45±0.51 (p=0.000), and from 7.84±1.7 to 6.89±0.9 (p=0.049) within 2 hours in HFNC and COT groups, respectively.","['patients with asthma exacerbation', 'forthy patients with moderate-to-severe asthma exacerbations, aged 18 years or older were enrolled', 'Inpatient Asthma']","['COT', 'high-flow nasal cannula (HFNC) and conventional oxygen therapy (COT', 'HFNC', 'HFNC or COT', 'High Flow Oxygenation']","['PaO2 and O2 saturation', 'Dyspnea scale', 'forced expiratory volume', 'Dyspnea scale, O2 saturation, spirometer indexes, respiratory and heart rate, and arterial blood gas (ABG', 'FEV1', 'complaint of nasal irritation and the device-produced heat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0183644', 'cui_str': 'Trolley'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0183441', 'cui_str': 'Spirometer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0240557', 'cui_str': 'Irritation of nose'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]",,0.149043,"Dyspnea scale decreased significantly from 7.58±1.04 to 6.45±0.51 (p=0.000), and from 7.84±1.7 to 6.89±0.9 (p=0.049) within 2 hours in HFNC and COT groups, respectively.","[{'ForeName': 'Sharare', 'Initials': 'S', 'LastName': 'Raeisi', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. shraeisi86@gmail.com.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Fakharian', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. fakharian_2005@yahoo.com.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'Tracheal Diseases Research Center (TDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr.f.ghorbani@gmail.com.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. hamidrezajamaati@gmail.com.'}, {'ForeName': 'Maryam Sadaat', 'Initials': 'MS', 'LastName': 'Mirenayat', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. mirenayat_m@yahoo.com.'}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v18i6.2174']
541,32105715,Prior and Perioperative Revascularization Does Not Affect Survival in Lung Transplant Patients.,"BACKGROUND


Coronary artery disease is common in lung transplant patients and has historically been viewed as a contraindication to the procedure. Although this mindset is changing, the effect of prior or perioperative revascularization on lung transplant survival outcomes is not adequately established.
METHODS


We performed a single-center retrospective analysis of all single and double lung transplant patients from 2012 to 2018 (n = 468). Patients were split into 4 groups: (1) patients who received a preoperative percutaneous coronary intervention (n = 34), (2) those who received coronary artery bypass grafting (CABG) before transplantation (n = 25), (3) those that received concomitant CABG during transplantation (n = 29), and (4) those who had lung transplantation with no need for revascularization (n = 380). Groups were compared for demographics, surgical procedure, and survival outcomes.
RESULTS


The no-revascularization group was statistically younger than the rest (P = .001). The lung allocation score trended toward being higher in the concomitant coronary artery bypass group (P = .03). All groups were predominantly diagnosed with idiopathic pulmonary fibrosis. The proportion of patients with chronic obstructive pulmonary disease was greatest in the group not requiring revascularization (P = .001). Patients with previous CABG were more likely to receive a single lung transplant than a double one (21 versus 4; P = .054). Length of stay, posttransplant survival, and postoperative adverse events were similar among all groups.
CONCLUSIONS


Results suggest that preoperative or intraoperative revascularization does not negatively affect survival in lung transplant patients; lung recipients with coronary artery disease have comparable survival when adequately revascularized.",2020,The proportion of patients with COPD was greatest in the group not requiring revascularization (p=0.001).,"['Patients with previous coronary artery bypass grafting', 'lung transplant patients', 'n=25), 3) patients that received', 'lung transplant patients; lung recipients with coronary artery disease', 'n=34), 2) patients that received', 'n=29), and 4) patients that had lung transplantation with no need for revascularization (n=380', 'lung transplant patients from 2012-2018 (n=468']","['concomitant coronary artery bypass grafting during transplantation', 'coronary artery bypass grafting prior to transplantation', 'pre-operative PCI']","['proportion of patients with COPD', 'demographics, surgical procedure, and survival outcomes', 'Length of stay, post-transplant survival, and postoperative adverse events', 'lung allocation score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4720844', 'cui_str': 'Lung allocation score'}]",2.0,0.0365361,The proportion of patients with COPD was greatest in the group not requiring revascularization (p=0.001).,"[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Kanaparthi', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania; Division of Cardiothoracic Surgery, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Kashem', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Suryapalam', 'Affiliation': 'Department of Biology, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Brann', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eros', 'Initials': 'E', 'LastName': 'Leotta', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Minakata', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Keshavamurthy', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Shigemura', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Toyoda', 'Affiliation': 'Division of Cardiovascular Surgery, Temple University Medical Center, Philadelphia, Pennsylvania. Electronic address: yoshiya.toyoda@tuhs.temple.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.01.016']
542,32119926,A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol.,"Annually approximately 2-3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: (Clinicaltrials.govNCT03569878).",2020,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","['424 patients will be randomized to peer-integrated collaborative care (n\u202f=\u202f212) and surgical team notification (n\u202f=\u202f212) conditions', 'integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care']","['information technology enhanced peer-integrated collaborative care intervention', 'peer integrated collaborative care intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}]",[],424.0,0.135098,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Scheuer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: hscheuer@uw.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Engstrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alliengs@uw.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Powers Pyles Sutter & Verville PC, 501 M Street, NW, Seventh Floor, Washington, DC 20005, United States of America. Electronic address: Peter.Thomas@PowersLaw.com.'}, {'ForeName': 'Rddhi', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: rddhim@uw.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moloney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: kmoloney@uw.edu.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Walen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: marylouw@uw.edu.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: peej23@uw.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: saraseo@uw.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Vaziri', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: nvaziri@uw.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alvmarti@uw.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ronmaier@uw.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: jerusso@uw.edu.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Sieber', 'Affiliation': 'Molecular Genomics Core/Microarray Group, National Institute of Environmental Health Sciences, P.O. Box 12233, Mail Drop D2-04, Durham, N.C 27709, United States of America. Electronic address: sieber@niehs.nih.gov.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Anziano', 'Affiliation': 'Shepherd Center, 2020 Peachtree Road NW, Atlanta, GA 30309-1465, United States of America. Electronic address: Pete.Anziano@shepherd.org.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America; The Koshka Foundation, United States of America. Electronic address: kanderson@koshkafoundation.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ebulger@uw.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington School of Medicine, 325 9th Ave., Seattle, WA 98104, United States of America. Electronic address: laurenkw@uw.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, 1705 NE Pacific St., Seattle, WA 98195, United States of America. Electronic address: heagerty@uw.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Palinkas', 'Affiliation': 'Department of Children, Youth and Families, USC Suzanne Dworak-Peck School of Social Work, 669 W 34(th) St., Los Angeles, CA 90089, United States of America. Electronic address: palinkas@usc.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: dzatzick@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105970']
543,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES


To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence.
PATIENTS AND METHODS


CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.
RESULTS


Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
CONCLUSION


Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038']
544,32145440,Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.,"BACKGROUND


Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.
METHODS


We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up.
CONCLUSION


GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.",2020,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"['176 patients', 'patients with PAD experience claudication despite adequate medical and/or surgical management', 'patients with lower extremity PAD']","['GM-CSF', 'placebo', 'Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF', 'granulocyte-macrophage colony stimulating factor', 'placebo group receive matching placebo injections', 'placebo injections']",['change in 6-min walk distance between baseline and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.40022,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Rogers', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Devinder S', 'Initials': 'DS', 'LastName': 'Dhindsa', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Risha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Martini', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahadev', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Iraj G', 'Initials': 'IG', 'LastName': 'Hesaroieh', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Frohwein', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kutner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Wells', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Duwayri', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Alabi', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Brewster', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. Electronic address: Aquyyum@Emory.Edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105975']
545,32061969,Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families.,"BACKGROUND


Community-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.
METHODS/DESIGN


This two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).
DISCUSSION


AFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT03761589 (12/3/2018).",2020,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","['Latino families', '6- to 11-year-old children (N\u202f=\u202f160) and their parents, relative to a wait-list control group', 'Latino populations', 'Athletes for Life (AFL), a community- and family-based intervention for Latino families', 'primarily Latino families']","['semiweekly sports skill programing and nutrition sessions', 'AFL']","['changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein', 'cardiorespiratory fitness and diet', 'health outcomes', 'Cardiovascular fitness']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.040074,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; The University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research, 7000 Fannin Street, #1200, Houston, TX 77030, USA; The University of Texas Health Science Center at Houston, Austin Campus, Michael Susan Dell Center for Healthy Living, 1616 Guadalupe Street, Suite 6.300, Austin, TX 78701, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Arizona State University, Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service & Community Solutions, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Arizona State University, Edson College of Nursing and Health Innovation, 550 North 3rd Street, Suite 301, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix Parks and Recreation, 212 East Alta Vista Rd, Phoenix, AZ 85042, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Behar', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Mays Cancer Center at UT Health San Antonio MD Anderson, 7979 Wurzbach Rd, San Antonio, TX 78229, USA.'}, {'ForeName': 'Anabell', 'Initials': 'A', 'LastName': 'Lorenzo-Quintero', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann Manrique', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA. Electronic address: ncrespo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105956']
546,32081787,Analysis of the Whole CDR3 T Cell Receptor Repertoire after Hematopoietic Stem Cell Transplantation in 2 Clinical Cohorts.,"A major cause of morbidity and mortality for patients who undergo hematologic stem cell transplantation (HSCT) is acute graft-versus-host disease (aGVHD), a mostly T cell-mediated disease. Examination of the T cell receptor (TCR) repertoire of HSCT recipients and the use of next-generation nucleotide sequencing have raised the question of whether features of TCR repertoire reconstitution might reproducibly associate with aGVHD. We hypothesized that the peripheral blood TCR repertoire of patients with steroid-nonresponsive aGVHD would be less diverse. We also hypothesized that patients with GVHD who shared HLA might also share common clones at the time of GVHD diagnosis, thereby potentially providing potential clinical indicators for treatment stratification. We further hypothesized that HSCT recipients with the same HLA mismatch might share a more similar TCR repertoire based on a potentially shared focus of alloreactive responses. We studied 2 separate patient cohorts and 2 separate platforms for measuring TCR repertoire. The first cohort of patients was from a multicenter Phase III randomized double-blinded clinical trial of patients who developed aGVHD (NCT01002742). The second cohort comprised samples from biobanks from 2 transplantation centers and the Center for International Blood and Marrow Transplant Research of patients who underwent mismatched HSCT. There were no statistically significant differences in the TCR diversity of steroid responders and nonresponders among patients with aGVHD on the day of diagnosis. Most clones in the repertoire were unique to each patient, but a small number of clones were found to be both exclusive to and shared among aGVHD nonresponders. We were also able to show a strong correlation between the presence of Vβ20 and Vβ29 and steroid responsiveness. Using the Bhattacharya coefficient, those patients who shared the same HLA mismatch were shown to be no more similar to one another than to those who had a completely different mismatch. Using 2 separate clinical cohorts and 2 separate platforms for analyzing the TCR repertoire, we have shown that the sampled human TCR repertoire is largely unique to each patient but contains glimmers of common clones of subsets of clones based on responsiveness to steroids in aGVHD on the day of diagnosis. These studies are informative for future strategies to assess for reproducible TCR responses in human alloreactivity and possible markers of GVHD responsiveness to therapy.",2020,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"['patients with steroid non-responsive, acute GVHD', 'patients with GVHD', 'patients who undergo hematological stem cell transplantations (HSCT']",['HSCT'],"['TCR diversity of steroid responders', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]",[],"[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0473044,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Shah', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Tamaresis', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Laura Jean', 'Initials': 'LJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Rangarajan', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Spellman', 'Affiliation': 'National Marrow Donor Program/C Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zehnder', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Everett H', 'Initials': 'EH', 'LastName': 'Meyer', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California. Electronic address: evmeyer@stanford.edu.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.01.020']
547,31327040,"Health-Related Quality of Life evaluation in ""left"" versus ""right"" access for percutaneous transhepatic biliary drainage using EORTC QLQBIL-21 questionnaire: a randomized controlled trial.","PURPOSE


To investigate the impact of the different access for percutaneous transhepatic biliary drainage (PTBD) in terms of ""Quality of Life"" (QoL) in the management of malignant obstructive jaundice.
METHODS


In this IRB-approved study, 64 consecutive patients with malignant obstructive jaundice were prospectively randomized to the right (group A) or left access (group B) for PTBD between February 2017 and December 2018. In order to demonstrate differences in terms of QoL between these groups, patients were asked to complete the ""EORTC QLQ-BIL21"" questionnaire the week after the treatment. Continuous variables were summarized by mean ± SD and compared using a Mann-Whitney U test.
RESULTS


Percutaneous transhepatic biliary drainages were performed through right access in 31 cases and 33 cases through left access. Technical success was achieved in all cases (100%). During 1 week's follow-up, there was a significant difference between group A and B in terms of pain (p < 0.001). Group A showed higher intercostal pain and respiratory difficulties compared to group B. Moreover, patients of group A showed a higher level of tiredness, anxiety, and more difficult tubes drainage and bags management than group B patients.
CONCLUSION


In our experience, the use of the questionnaires showed the right access is associated with intercostal pain and respiratory difficulties. Left access for PTBD provides a better Quality of Life for patients who underwent PTBD as palliative treatment for the management of malignant obstructive jaundice and could be considered as the approach of choice in case of distal obstruction.",2020,"During 1 week's follow-up, there was a significant difference between group A and B in terms of pain (p < 0.001).","['64 consecutive patients with malignant obstructive jaundice', 'percutaneous transhepatic biliary drainage using EORTC QLQBIL-21 questionnaire']",['percutaneous transhepatic biliary drainage (PTBD'],"['Technical success', 'intercostal pain and respiratory difficulties', 'pain', 'Quality of Life"" (QoL', 'level of tiredness, anxiety, and more difficult tubes drainage and bags management', 'Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C1504490', 'cui_str': 'Percutaneous transhepatic biliary drainage'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C1504490', 'cui_str': 'Percutaneous transhepatic biliary drainage'}, {'cui': 'C0657162', 'cui_str': ""perfluoro-2,2,2',2'-tetramethyl-4,4'-bis(1,3-dioxolane)""}]","[{'cui': 'C0877023', 'cui_str': 'Pain of intercostal space (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}]",64.0,0.0371902,"During 1 week's follow-up, there was a significant difference between group A and B in terms of pain (p < 0.001).","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Castiglione', 'Affiliation': 'Section of Radiological Science, Bi.N.D, University of Palermo, Via del Vespro, 127, 90127, Palermo, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Gozzo', 'Affiliation': 'Section of Radiological Science, Bi.N.D, University of Palermo, Via del Vespro, 127, 90127, Palermo, Italy. ceciliagozzo91@gmail.com.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mammino', 'Affiliation': 'Unità di Radiologia I, Azienda Ospedaliero Universitaria ""Policlinico-Vittorio Emanuele"", Via Santa Sofia 78, 95125, Catania, CT, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Failla', 'Affiliation': 'Diagnostica per Immagini e Radiologia Interventistica, Azienda Ospedaliera per l\'Emergenza ""Cannizzaro"", Via Messina 829, 95126, Catania, CT, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palmucci', 'Affiliation': 'Unità di Radiologia I, Azienda Ospedaliero Universitaria ""Policlinico-Vittorio Emanuele"", Via Santa Sofia 78, 95125, Catania, CT, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Basile', 'Affiliation': 'Unità di Radiologia I, Azienda Ospedaliero Universitaria ""Policlinico-Vittorio Emanuele"", Via Santa Sofia 78, 95125, Catania, CT, Italy.'}]",Abdominal radiology (New York),['10.1007/s00261-019-02136-7']
548,31961448,A fully Bayesian mixture model approach for identifying noncompliance in a regulatory tobacco clinical trial.,"Identifying noncompliance in a randomized trial is challenging, but could be improved by leveraging biomarker data to identify participants that did not comply with their assigned treatment. For randomized trials of very low nicotine content (VLNC) cigarettes, the biomarker of total nicotine equivalents (TNE) could be used to identify noncompliance. Compliant participants should have lower levels of TNEs than participants that did not comply and smoked normal nicotine content cigarettes, resulting in a mixture of compliant and noncompliant participants at each dose level. Thresholds of TNE could then be identified from the compliant groups at each dose level and used to determine which study participants were compliant. Furthermore, proposed biological relationships of TNE with nicotine dose could be incorporated into improve the efficiency of estimation, but may introduce bias if misspecified. To account for multiple modeling assumptions across dose levels, we explore model averaging via reversible jump markov chain monte carlo (MCMC) within each dose level to take advantage of improvements in efficiency when the proposed relationship is true and to downweight the biological model when it is misspecified. In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate. We apply our approach to data from a randomized trial of VLNC cigarettes to estimate TNE thresholds and probability of compliance curves as a function of TNEs for each nicotine dose used in the trial.",2020,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.",[],"['VLNC', 'total nicotine equivalents (TNE', 'low nicotine content (VLNC) cigarettes', 'TNE']",['mean square error (MSE'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}]",,0.0934155,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Kaizer', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}]",Statistics in medicine,['10.1002/sim.8478']
549,31826731,Neuroimaging in Ischemic Stroke Is Different Between Men and Women in the DEFUSE 3 Cohort.,"Background and Purpose- Clinical deficits from ischemic stroke are more severe in women, but the pathophysiological basis of this sex difference is unknown. Sex differences in core and penumbral volumes and their relation to outcome were assessed in this substudy of the DEFUSE 3 clinical trial (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke). Methods- DEFUSE 3 randomized patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging. Using univariate and adjusted regression models, the effect of sex was assessed on prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans. Results- All patients were included in the analysis (n=182) with 90 men and 92 women. There was no sex difference in the site of baseline arterial occlusion. Adjusted by age, baseline National Institutes of Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes than men. Median (interquartile range) volumes for core were 8.0 mL (1.9-18.4) in women versus 12.6 mL (2.7-29.6) in men, for T max >6 seconds 89.0 mL (63.8-131.7) versus 133.9 mL (87.0-175.4), and for mismatch 82.1mL (53.8-112.8) versus 108.2 (64.1-149.2). The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003). Conclusions- In the large vessel ischemic stroke cohort selected for DEFUSE 3, women had imaging evidence of better collateral circulation, smaller baseline core volumes, and slower ischemic core growth. These observations suggest sex differences in hemodynamic and temporal features of anterior circulation large artery occlusions. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2020,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","['All patients were included in the analysis (n=182) with 90 men and 92 women', 'Men and Women in the DEFUSE 3 Cohort', 'patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging']","[' and Purpose', 'Conclusions', 'Methods']","['prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans', 'Median (interquartile range) volumes', 'Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes', 'hypoperfusion intensity ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1275506', 'cui_str': 'Imaging modality'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",182.0,0.369744,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","[{'ForeName': 'Adrienne N', 'Initials': 'AN', 'LastName': 'Dula', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Zuck', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028205']
550,31859791,Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial.,"OBJECTIVE


To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and ""as needed"" following middle-of-the-night awakenings.
METHODS


Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and ""as-needed"") and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and ""as-needed""). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires.
RESULTS


Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness. Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours. Changes in sleep quality and insomnia severity scores were also favorable and comparable between groups: variation depended on continuation of treatment. Regarding PSG findings, sleep latency decreased more in the sublingual group than the oral group (-14±42 vs. 10±29 min; p = 0.03). The psychomotor vigilance test showed minor residual effects 30 minutes after awakening, which reversed after 2 hours.
CONCLUSIONS


The safety and efficacy of both zolpidem formulations are comparable. The sublingual 5 mg dose induced sleep more rapidly.
CLINICAL TRIAL REGISTRATION


NCT01896336.",2020,Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours.,"['67 met the criteria for insomnia (48±10 years; 79% women', 'Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires', '85 patients', 'insomnia disorder', 'Participants']","['zolpidem', 'oral group (oral zolpidem 10 mg and sublingual placebo', 'Sublingual and oral zolpidem', 'sublingual group (oral placebo and sublingual zolpidem']","['sleep quality and insomnia severity scores', 'safety and efficacy', 'middle-of-the-night awakenings', 'total sleep time', 'headache, sleepiness, and dizziness', 'sleep latency', 'Mild-to-moderate adverse events']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0804871,Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Castro', 'Affiliation': 'Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Leonardo J', 'Initials': 'LJ', 'LastName': 'Otuyama', 'Affiliation': 'Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Fumo-Dos-Santos', 'Affiliation': 'Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Dalva', 'Initials': 'D', 'LastName': 'Poyares', 'Affiliation': 'Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0389']
551,31764108,High yield of new HIV diagnoses during active case-finding for tuberculosis.,"OBJECTIVE


To evaluate the utility of a broad and nonspecific symptom screen for identifying people with undiagnosed HIV infection.
DESIGN


Secondary analysis of operational data collected during implementation of a cluster-randomized trial for tuberculosis case detection.
METHODS


As part of the trial, adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya. Adults reporting any symptom were offered HIV testing. We analysed the HIV testing data from this study, using modified Poisson regression, to identify predictors of new HIV diagnoses among adults with symptoms and initially unknown HIV status.
RESULTS


We identified 3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV. The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units. More men were diagnosed with HIV than women, despite fewer men being screened. People who reported 4-5 symptoms were over twice as likely to be diagnosed with HIV compared to those reporting 1-3 symptoms (adjusted prevalence ratio in health facilities = 2.58, 95% CI 1.65-4.05; adjusted prevalence ratio in mobile units = 2.63, 95% CI 1.37-5.03).
CONCLUSION


We observed a high yield of new HIV diagnoses among adults identified by active application of a broad symptom screen. Use of integrated tuberculosis and HIV screening could help close the detection gap for both conditions.",2019,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"['3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV', 'adults with symptoms and initially unknown HIV status', 'adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya', 'people with undiagnosed HIV infection']",['integrated tuberculosis and HIV screening'],['prevalence of new HIV diagnoses'],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0028081', 'cui_str': 'Night sweats (finding)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0459958', 'cui_str': 'HIV screening test'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.435401,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mchembere', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Agaya', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Yuen', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Okelloh', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Achola', 'Affiliation': 'Kenya Medical Research Institute, US Army Medical Research Directorate - Kenya, Kisumu, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Opole', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cowden', 'Affiliation': 'US Army Medical Research Directorate - Kenya.'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Muttai', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Martien W', 'Initials': 'MW', 'LastName': 'Borgdorff', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Cain', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002354']
552,32151753,Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial.,"A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults-a population disproportionately affected by asthma. The primary goals were to help participants reduce allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change. HIITBAC had two groups: clinic-only and home-visit groups. Both groups received enhanced clinical care, but the home-visit group also received a detailed home assessment and four additional home visits spaced over roughly one year. We recruited 263 participants. Of these, 152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach). Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group. We describe the HIITBAC methodology and cohort, discuss lessons learned about recruitment and retention, and highlight adaptations we implemented to address these lessons.",2020,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","['152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach', 'African-American adults-a population disproportionately affected by asthma', 'HIITBAC had two groups: clinic-only and home-visit groups', 'Houston-area African-American adults with asthma', '263 participants', 'Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group', 'African Americans']","['home-based intervention', 'Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC']","['allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change', 'asthma control and quality of life']","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348027', 'cui_str': 'Irritant (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",263.0,0.076198,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","[{'ForeName': 'Rebecca Jensen', 'Initials': 'RJ', 'LastName': 'Bruhl', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: Rebecca.J.Bruhl@bcm.edu.'}, {'ForeName': 'William Brett', 'Initials': 'WB', 'LastName': 'Perkison', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Abiodun O', 'Initials': 'AO', 'LastName': 'Oluyomi', 'Affiliation': 'Section of Epidemiology and Population Science, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ellen Baskin', 'Initials': 'EB', 'LastName': 'Fiesinger', 'Affiliation': 'Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'College of Nursing, Prairie View A&M University, Houston, TX, United States.'}, {'ForeName': 'Winifred J', 'Initials': 'WJ', 'LastName': 'Hamilton', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Butler', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Cellie', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Galvan', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': ""Frene'"", 'Initials': 'F', 'LastName': 'Lacour-Chestnut', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Shereda', 'Initials': 'S', 'LastName': 'Pannell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Phipps', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Adriene', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Boles', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ritupreet', 'Initials': 'R', 'LastName': 'Virk', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Guffey', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Ramamurthy', 'Affiliation': 'Office of Research Information Technology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Persse', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States; Emergency Medical Services, Houston Fire Department, City of Houston, TX, United States.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Maffei', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Wenyaw', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Reyes', 'Affiliation': 'U.S. Department of Housing & Urban Development, Washington, DC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105977']
553,32171937,Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol.,"INTRODUCTION


Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee.
METHODS/DESIGN


150 participants will be enrolled into this randomized controlled trial. Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL). Movement training will promote between-limb symmetry and surgical knee loading during activity-based exercises. Movement training strategies will include real-time biofeedback using in-shoe pressure sensors and verbal, visual, and tactile cues from the physical therapist. The primary outcome will be change in peak knee extension moment in the surgical knee during walking, from before surgery to six months after surgery. Secondary outcomes will include lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA.
DISCUSSION


This study will provide insights into the efficacy of movement training after unilateral TKA, along with mechanisms for optimizing long-term physical function and minimizing negative sequelae of compensatory movement patterns.",2020,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"['150 participants', 'total knee arthroplasty']","['Movement training', 'standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL', 'TKA', 'Total knee arthroplasty (TKA', 'Movement pattern biofeedback training']","['lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA', 'risk of osteoarthritis (OA) progression', 'peak knee extension moment in the surgical knee during walking']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",150.0,0.0895054,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bade', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America. Electronic address: michael.bade@ucdenver.edu.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Christensen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Zeni', 'Affiliation': 'Rutgers University, School of Health Professions, Newark, NJ, United States of America.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Dayton', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Veterans Affairs Rocky Mountain Mental Illness, Research, Education and Clinical Center, VA Eastern Colorado Healthcare System, Aurora, CO, United States of America.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Cheuy', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105973']
554,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION


When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN


OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION


The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
555,32087342,"The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.","BACKGROUND


Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors.
PURPOSE


Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older.
METHODS


Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months.
CONCLUSIONS


If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.",2020,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","['530 adults, ages 18 and older']","['1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM\u202f+\u202fFB, where participants self-monitor and receive real-time, tailored feedback (FB']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",530.0,0.0361057,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","[{'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America. Electronic address: lbu100@pitt.edu.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Parmanto', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Beatrice', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Cajita', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Loar', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Pulantara', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kariuki', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Cedillo', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'University of Pittsburgh, Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105958']
556,32242241,Comment on Li et al.: Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,,2020,,['high tibial osteotomy'],[' Drainage relieves pain without increasing post-operative blood loss'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",[],,0.0521105,,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'The Third Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. helloyh2008@126.com.'}]",International orthopaedics,['10.1007/s00264-020-04555-4']
557,32234275,"Does Telehealth Delivery of a Dyadic Dementia Care Program Provide a Noninferior Alternative to Face-To-Face Delivery of the Same Program? A Randomized, Controlled Trial.","OBJECTIVE


This study aimed to determine whether delivery of a dyadic intervention using telehealth was noninferior to delivery of the same program using traditional face-to-face delivery through home visits.
DESIGN


We conducted a noninferiority randomized controlled trial.
PARTICIPANTS


Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms.
INTERVENTION


Participants were randomized to receive either telehealth or home visit delivery of the same intervention program.
MEASUREMENTS


The primary outcome was the Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia. Therapists delivering the intervention recorded the time spent delivering the intervention as well as travel time.
RESULTS


Sixty-three dyads were recruited and randomized. Both groups reported improvements for the primary outcome, however, these were not statistically significant. There were no significant differences between groups for the primary outcome (mean difference 0.09 (95% confidence interval -1.26 to 1.45) or the secondary outcomes at 4 months. Both groups reported significant improvements in caregiver's perceptions of change. The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
CONCLUSION


It is feasible to offer dyadic interventions via telehealth and doing so reduces travel time and results in similar benefits for families.",2020,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
","['Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms', 'Sixty-three dyads were recruited and randomized']",['telehealth or home visit delivery of the same intervention program'],"['travel time', ""Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia""]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1269688', 'cui_str': 'Activities of daily living management'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",63.0,0.213133,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia. Electronic address: Kate.Laver@flinders.edu.au.'}, {'ForeName': 'Enwu', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'University of Sydney (LC), Sydney, New South Wales, Australia.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Davies', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'University of Queensland (LG), Queensland, Australia.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Drexel University (LNG), Philadelphia, PA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.009']
558,32145441,A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings.,"INTRODUCTION


Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.
METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy - General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).
DISCUSSION


Multilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study. ClinicalTrials.gov Registration #NCT03699748.",2020,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","['community centers participating in the study', 'minority patients diagnosed with cancer in community settings', 'low-income and minority employees diagnosed with cancer in outpatient community settings', 'and minority hourly-wage workers with cancer, in two community settings', 'The ""Lay health worker Educates Engages and Activates Patients to', 'patients newly diagnosed with cancer']","['advance care planning and symptom management among low-income', 'LEAPS intervention', 'Share (LEAPS)"" intervention', 'multi-level intervention']","['quality of life', 'total healthcare use and healthcare costs', 'patient activation, patient satisfaction with healthcare decision-making, and symptom burden']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.104465,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America. Electronic address: manalip@stanford.edu.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Khateeb', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA, United States of America; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105971']
559,32147571,A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.,"BACKGROUND


Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS


A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION


This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.",2020,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","['Disease-free breast cancer survivors (n\xa0=\xa0422) who completed', 'Cancer-related fatigue', 'University of Rochester Medical Center (URMC']","['bupropion', 'placebo', 'chemotherapy', 'Behavioral interventions include exercise and cognitive-behavioral therapy']","['efficacy and tolerability', 'cognition and symptomatology', 'fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'cancer-related fatigue', 'quality of life, depression, and drug tolerability']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",422.0,0.134713,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hyo Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Julienne', 'Initials': 'J', 'LastName': 'Bower', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Margarita Bobonis', 'Initials': 'MB', 'LastName': 'Babilonia', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Peppone', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105976']
560,32092439,Evaluating the effect of individually-targeted food incentives on grocery purchases: The smart cart study protocol for a randomized controlled cross-over trial.,"BACKGROUND/AIMS


Health stakeholders are interested in the promise of healthy food incentives to improve dietary quality. The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
DESIGN


Randomized controlled crossover design of 224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires. Participants were randomized using 1:1 blocked randomization; all participants received a 5% discount on their purchases with their loyalty card. For the first 13-weeks, the intervention group received individually-targeted weekly coupons (valued up to $10) with brief nutrition education to improve grocery purchase quality. The study team developed healthy food coupons, and the study algorithm allocated targeted coupons to participants' loyalty cards using purchase history, dietary preferences/allergies, and baseline diet quality. Control participants received weekly untargeted nutrition education and occasional generic coupons. Following a 2-4 week washout period, the two groups crossed over. The primary study outcomes were purchases of targeted products and grocery purchase quality measured using the validated Grocery Purchase Quality Index-2016; the study was powered to detect a minimum 3% difference in purchase quality.
CONCLUSIONS


The Smart Cart Study tested a novel application of automated individually-targeted marketing using customer purchase history, dietary quality, and preferences to identify and deliver targeted incentives to improve grocery purchase quality. Future research could scale this program through collaboration between multiple stakeholders, including supermarkets, workplace wellness initiatives and insurance companies.",2020,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[""224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires""]","['untargeted nutrition education and occasional generic coupons', 'individually-targeted weekly coupons (valued up to $10) with brief nutrition education']","['purchase quality', 'purchases of targeted products and grocery purchase quality']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",224.0,0.0760648,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[{'ForeName': 'Maya K', 'Initials': 'MK', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America. Electronic address: Maya_vadiveloo@uri.edu.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Haley W', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Perraud', 'Affiliation': 'AgroParis Tech., 75231 Paris, Ile-de-France, France.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atlas', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'General Internal Medicine Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105966']
561,30753303,Rehabilitation After Hip Fracture for Nursing Home Residents: A Controlled Feasibility Trial.,"BACKGROUND


This study compared functional outcomes at 3 months after hip fracture surgery between nursing home residents participating in a 10-week outreach rehabilitation program and those receiving usual care. Function, health-related quality of life, and mortality were also compared over 12 months, and outreach program feasibility was assessed.
METHODS


A feasibility trial was undertaken in Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition. Outreach participants received 10 weeks of rehabilitation (30 sessions), and Control participants received usual posthospital fracture care in their nursing homes. The primary outcome was the Functional Independence Measure Physical Domain (FIMphysical) score 3 months post-fracture; we also explored FIM Locomotion and Mobility. Secondary outcomes were FIM scores, EQ-5D-3L scores, and mortality over 12 months. Program feasibility was also evaluated.
RESULTS


The mean age was 88.7 ± 7.0 years, 55 (71%) were female, and 58 (75%) had severe cognitive impairment with no significant group differences (p > .14). Outreach participants had significantly higher FIM Locomotion than usual care (p = .02), but no significant group differences were seen in FIMphysical or FIM Mobility score 3 months post-fracture. In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared with Control participants over 12 months (p < .05). Mortality did not differ by group (p = .80). Thirty (65%) Outreach participants completed the program.
CONCLUSIONS


Our feasibility trial demonstrated that Outreach participants achieved better locomotion by 3 months post-fracture compared with participants receiving usual postfracture care; benefits were sustained to 12 months post-fracture. In adjusted analyses, Outreach participants also showed sustained benefits in physical function and health-related quality of life.",2019,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","['Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition', 'Nursing Home Residents', 'hip fracture surgery between nursing home residents participating in a 10-week']","['outreach rehabilitation program and those receiving usual care', 'rehabilitation (30 sessions) and Control participants received usual post-hospital fracture care in their nursing homes']","['Mortality', 'Function, health-related quality of life (HRQL) and mortality', 'FIM scores, EQ-5D-3L scores and mortality over 12-months', 'FIM Locomotion and Mobility', 'better locomotion', 'FIM Locomotion', 'FIM and EQ-5D-3L scores', 'physical function and HRQL', 'severe cognitive impairment', 'Functional Independence Measure Physical Domain(FIMphysical) score', 'FIMphysical or FIM Mobility score']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1160964', 'cui_str': 'Fracture care'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",77.0,0.0812392,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Magaziner', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'C Allyson', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Gian S', 'Initials': 'GS', 'LastName': 'Jhangri', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'D William C', 'Initials': 'DWC', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz031']
562,30798684,Laser Acupuncture for Relieving Nausea and Vomiting in Pediatric Patients Undergoing Chemotherapy: A Single-Blind Randomized Clinical Trial.,"Nausea and vomiting are frequent side effects associated with chemotherapy treatments. The aim of this study was to evaluate the efficacy of laser acupuncture in relieving nausea and vomiting in children and adolescents undergoing laser treatment. This is an experimental, randomized, single-blind study. The research was carried out at the INCA (Instituto Nacional de Câncer), a reference institution in the control and treatment of cancer, located in the city of Rio de Janeiro, Brazil. The research project was approved by the INCA Research and Ethics Committee under Registration No. 164/14 and CAAE 3374551.0.3001.5274. Children and adolescents between the ages of 6 and 17 years who were undergoing chemotherapy with drugs of high and medium degrees of emetogenic toxicity were selected. The participants were divided into two groups, A and B. In A, the active acupuncture was applied, and in B, the placebo acupuncture was applied. Analysis of the data indicated that there was significant relief from nausea in the intervention group when compared with the placebo group. A decrease in the number of episodes of vomiting on the second and third days of chemotherapy was also observed. On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group. The study concluded that laser acupuncture was effective in relieving nausea within 5 days of chemotherapy and in reducing the number of episodes of vomiting on Days 2 and 3 after chemotherapy.",2019,"On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group.","['children and adolescents undergoing laser treatment', 'Children and adolescents between the ages of 6 and 17 years who were undergoing chemotherapy with drugs of high and medium degrees of emetogenic toxicity were selected', 'Pediatric Patients']","['placebo', 'placebo acupuncture', 'Laser Acupuncture', 'Undergoing Chemotherapy', 'laser acupuncture']","['nausea and vomiting', 'Nausea and Vomiting', 'number of episodes of vomiting', 'relieving nausea', 'Nausea and vomiting', 'nausea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture (regime/therapy)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.102321,"On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group.","[{'ForeName': 'Cristiane da Silva', 'Initials': 'CDS', 'LastName': 'Varejão', 'Affiliation': '1 Cancer Chemotherapy Center of the National Cancer Institute, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Fátima H do Espírito', 'Initials': 'FHDE', 'LastName': 'Santo', 'Affiliation': '2 Aurora de Afonso Costa School of Nursing, Fluminense Federal University, (MPEA/EEAAC/UFF), Niterói, RJ, Brazil.'}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454218810140']
563,32030526,Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.,"Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.",2020,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.",['Men who have sex with men and transgender women who had multiple sexual partners in the prior 3\xa0months participated in'],"['ISUM', 'free rapid HIV self-test kits', 'self- and partner-testing in New York City and San Juan, PR']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0558265', 'cui_str': 'Multiple sexual contacts (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]",[],114.0,0.0231364,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. rebecca.giguere@nyspi.columbia.edu.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02809-1']
564,31607468,Hepcidin-guided screen-and-treat interventions against iron-deficiency anaemia in pregnancy: a randomised controlled trial in The Gambia.,"BACKGROUND


WHO recommends daily iron supplementation for pregnant women, but adherence is poor because of side-effects, effectiveness is low, and there are concerns about possible harm. The iron-regulatory hormone hepcidin can signal when an individual is ready-and-safe to receive iron. We tested whether a hepcidin-guided screen-and-treat approach to combat iron-deficiency anaemia could achieve equivalent efficacy to universal administration, but with lower exposure to iron.
METHODS


We did a three-arm, randomised, double-blind, non-inferiority trial in 19 rural communities in the Jarra West and Kiang East districts of The Gambia. Eligible participants were pregnant women aged 18-45 years at between 14 weeks and 22 weeks of gestation. We randomly allocated women to either WHO's recommended regimen (ie, a daily UN University, UNICEF, and WHO international multiple-micronutrient preparation [UNIMMAP] containing 60 mg iron), a 60 mg screen-and-treat approach (ie, daily UNIMMAP containing 60 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L), or a 30 mg screen-and-treat approach (ie, daily UNIMMAP containing 30 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L). We used a block design stratified by amount of haemoglobin at enrolment (above and below the median amount of haemoglobin on every enrolment day) and stage of gestation (14-18 weeks vs 19-22 weeks). Participants and investigators were unaware of the random allocation. The primary outcome was the amount of haemoglobin at day 84 and was measured as the difference in haemoglobin in each screen-and-treat group compared with WHO's recommended regimen; the non-inferiority margin was set at -5·0 g/L. The primary outcome was assessed in the per-protocol population, which comprised all women who completed the study. This trial is registered with the ISRCTN registry, number ISRCTN21955180.
FINDINGS


Between June 16, 2014, and March 3, 2016, 498 participants were randomised, of whom 167 were allocated to WHO's recommended regimen, 166 were allocated to the 60 mg per day screen-and-treat approach, and 165 were allocated to the 30 mg per day screen-and-treat approach. 78 participants were withdrawn or lost to follow-up during the study; thus, the per-protocol population comprised 140 women assigned to WHO's recommended regimen, 133 allocated to the 60 mg screen-and-treat approach, and 147 allocated to the 30 mg screen-and-treat approach. The screen-and-treat approaches did not exceed the non-inferiority margin. Compared with WHO's recommended regimen, the difference in the amount of haemoglobin at day 84 was -2·2 g/L (95% CI -4·6 to 0·1) with the 60 mg screen-and-treat approach and -2·7 g/L (-5·0 to -0·5) with the 30 mg screen-and-treat approach. Adherence, reported side-effects, and adverse events were similar between the three groups. The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1). No participants died during the study.
INTERPRETATION


The hepcidin-guided screen-and-treat approaches had no advantages over WHO's recommended regimen in terms of adherence, side-effects, or safety outcomes. Our results suggest that the current WHO policy for iron administration to pregnant women should remain unchanged while more effective approaches continue to be sought.
FUNDING


Bill & Melinda Gates Foundation and the UK Medical Research Council.",2019,"The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1).","['19 rural communities in the Jarra West and Kiang East districts of The Gambia', ""78 participants were withdrawn or lost to follow-up during the study; thus, the per-protocol population comprised 140 women assigned to WHO's recommended regimen, 133 allocated to the 60 mg"", 'deficiency anaemia in pregnancy', 'Eligible participants were pregnant women aged 18-45 years at between 14 weeks and 22 weeks of gestation', 'Between June 16, 2014, and March 3, 2016', '498 participants', 'pregnant women']","['hepcidin-guided screen-and-treat approach to combat iron-deficiency anaemia', ""WHO's recommended regimen (ie, a daily UN University, UNICEF, and WHO international multiple-micronutrient preparation [UNIMMAP] containing 60 mg iron), a 60 mg screen-and-treat approach (ie, daily UNIMMAP containing 60 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L), or a 30 mg screen-and-treat approach (ie, daily UNIMMAP containing 30 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L"", 'screen-and-treat approach, and 147 allocated to the 30 mg screen-and-treat approach', 'Hepcidin-guided screen-and-treat interventions against iron']","['haemoglobin', 'frequency of stomachache', 'Adherence, reported side-effects, and adverse events', 'amount of haemoglobin']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0325167', 'cui_str': 'Equus kiang (organism)'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0041782', 'cui_str': 'Deficiency anemias (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041682', 'cui_str': 'UNICEF'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0221512', 'cui_str': 'Stomach ache (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",498.0,0.359444,"The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1).","[{'ForeName': 'Amat', 'Initials': 'A', 'LastName': 'Bah', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK.'}, {'ForeName': 'Abdul Khalie', 'Initials': 'AK', 'LastName': 'Muhammad', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wegmuller', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; GroundWork, Flaesch, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Verhoef', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, Netherlands; LSHTM, London, UK.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Goheen', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; University of North Carolina at Chapel Hill School of Medicine, Department of Microbiology and Immunology, Chapel Hill, NC, USA.'}, {'ForeName': 'Saikou', 'Initials': 'S', 'LastName': 'Sanyang', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Ebrima', 'Initials': 'E', 'LastName': 'Danso', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Ebrima A', 'Initials': 'EA', 'LastName': 'Sise', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, and Department of Medical Biology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Armitage', 'Affiliation': 'MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Drakesmith', 'Affiliation': 'MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Moore', 'Affiliation': ""Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; Department of Women & Children's Health, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Cerami', 'Affiliation': 'LSHTM, London, UK.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Prentice', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK. Electronic address: aprentice@mrc.gm.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30393-6']
565,31853772,Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.,"ISUM (""I'll show you mine"") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.",2020,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","['Screen Potential Sexual Partners', 'to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group', '272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU']","['ST', 'ISUM (""I\'ll show you mine', 'Rapid HIV Self-Test']",['CAI occasions'],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],,0.0544861,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ac72@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02763-7']
566,31129443,Chlorhexidine versus saline in reducing the risk of catheter associated urinary tract infection: A cost-effectiveness analysis.,"BACKGROUND


Catheter associated urinary tract infections are one of the most common infections acquired in hospital. A recent randomised control study demonstrated the benefit of using chlorhexidine (0.1%) for meatal cleaning prior to urinary catheter insertion, by reducing both catheter associated asymptomatic bacteriuria and infection. These findings raise the important question of whether a decision to switch from saline to chlorhexidine was likely to be cost-effective. The aim of this paper was to evaluate the cost-effectiveness of adopting routine use of chlorhexidine for meatal cleaning prior to urinary catheter insertion METHODS: The outcomes of this cost-effectiveness study are changes to health service costs in $AUD and changes to quality adjusted life years from a decision to adopt 0.1% chlorhexidine for meatal cleaning prior to urinary catheter insertion as compared to saline. Effectiveness outcomes for this study were taken from a 32 week stepped wedge randomised controlled study conducted in three Australian hospitals.
RESULTS


The changes in health costs from switching from saline to 0.1% chlorhexidine per 100,000 catheterisations would save hospitals AUD$387,909 per 100,000 catherisations, prevent 70 cases of catheter associated urinary tract infections, release 282 bed days and provide a small improvement in health benefits of 1.43 quality adjusted life years. Using a maximum willingness to pay for a marginal quality adjusted life year threshold of AUD$28,000 per 100,000 catherisations, suggests that adopting chlorhexidine would be cost effective and potentially cost-saving.
CONCLUSION


The findings from our work provide evidence to health system administrators and those responsible for drafting catheter associated urinary tract infections prevention guidelines that investing in switching from saline to chlorhexidine is not only clinically effective but also a sensible decision in the context of allocating finite healthcare resources.",2019,"The changes in health costs from switching from saline to 0.1% chlorhexidine per 100,000 catheterisations would save hospitals AUD$387,909 per 100,000 catherisations, prevent 70 cases of catheter associated urinary tract infections, release 282 bed days and provide a small improvement in health benefits of 1.43 quality adjusted life years.",['32 week stepped wedge randomised controlled study conducted in three Australian hospitals'],"['Chlorhexidine versus saline', 'chlorhexidine']","['health service costs', 'risk of catheter associated urinary tract infection', 'cost effective and potentially cost-saving', 'health costs', 'cost-effectiveness']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0766568,"The changes in health costs from switching from saline to 0.1% chlorhexidine per 100,000 catheterisations would save hospitals AUD$387,909 per 100,000 catherisations, prevent 70 cases of catheter associated urinary tract infections, release 282 bed days and provide a small improvement in health benefits of 1.43 quality adjusted life years.","[{'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, 185 Fox Valley Road, Wahroonga, New South Wales 2076, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, New South Wales, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}, {'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute, Australian Catholic University & St Vincent's Health Australia Sydney, New South Wales, Australia; Lifestyle Research Centre, Avondale College of Higher Education, Cooranbong, New South Wales, Australia.""}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Infectious Prevention and Healthcare Epidemiology Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gregory', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, 185 Fox Valley Road, Wahroonga, New South Wales 2076, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine Australian Catholic University, Watson Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collignon', 'Affiliation': 'Australian Capital Territory Pathology, Canberra Hospital and Health Services, Yamba Drive, Garran, Australian Capital Territory 2605, Australia; Medical School, Australian National University, Acton, Australian Capital Territory 2601, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.04.003']
567,28810394,Adapting evidence-based behavioral weight loss programs for emerging adults: A pilot randomized controlled trial.,"Emerging adults are at high risk of obesity but behavioral weight loss programs do not meet their needs. Emerging adults ( N = 52, age = 22.3 ± 2 years, body mass index = 34.2 ± 5.5 kg/m 2 , 46.2% non-Hispanic White) were randomly assigned to one of three behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid). Assessments occurred at 0 and 3 months. Engagement and self-monitoring were highest in Hybrid. Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid. Percent achieving ⩾5 percent weight loss was highest in Hybrid (63%). Findings suggest potential for adapted behavioral weight loss to promote engagement and weight loss in emerging adults.",2019,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","['Emerging adults ( N\u2009=\u200952, age\u2009=\u200922.3\u2009±\u20092\u2009years, body mass index\u2009=\u200934.2\u2009±\u20095.5\u2009kg/m 2 , 46.2% non-Hispanic White', 'emerging adults']","['behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0311466,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': '2 The University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Blumenthal', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Caccavale', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': '3 The Miriam Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105316688951']
568,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
569,32230729,The Possibility of Suppression of Increased Postprandial Blood Glucose Levels by Gamma-Polyglutamic Acid-Rich Natto in the Early Phase after Eating: A Randomized Crossover Pilot Study.,"The natto containing high levels of gamma-polyglutamic acid (γ-PGA) was recently developed. We investigated the effect of γ-PGA-rich natto consumption on postprandial glycemic excursion in humans. A randomized crossover meal test study was performed on healthy volunteers aged 20-64 years using the following test meals: (1) white rice (WR), (2) low-γ-PGA natto meal (WR + low-γ-PGA natto), and (3) high-γ-PGA natto meal (WR + high-γ-PGA natto). Blood samples were obtained at each visit before and for 120 min after loading. The incremental area under the curve (IAUC) of blood glucose and insulin levels was calculated and compared among the test meals. The blood glucose's IAUC at 0-120 min, the primary endpoint, was 20.1% and 15.4% lower for the high- and low-γ-PGA natto meal than for the WR, with a significant difference only between the high-γ-PGA natto meal and WR ( p  < 0.05). The blood glucose's IAUC at 0-15, 0-30, and 0-45 min was lower for the high-γ-PGA natto meal than for the low-γ-PGA natto meal (all  p  < 0.05). The possibility that high-γ-PGA natto might suppress blood glucose elevations in the early phase after eating is indicated.",2020,"The blood glucose's IAUC at 0-15, 0-30, and 0-45 min was lower for the high-γ-PGA natto meal than for the low-γ-PGA natto meal (all  p  < 0.05).","['humans', 'healthy volunteers aged 20-64 years using the following', 'Early Phase after Eating']","['test meals: (1) white rice (WR), (2) low-γ-PGA natto meal (WR + low-γ-PGA natto), and (3) high-γ-PGA natto meal (WR + high-γ-PGA natto', 'γ-PGA-rich natto consumption', 'gamma-polyglutamic acid (γ-PGA']","[""blood glucose's IAUC"", 'Postprandial Blood Glucose Levels', 'high-γ-PGA natto meal and WR', 'blood glucose elevations', 'incremental area under the curve (IAUC) of blood glucose and insulin levels', 'postprandial glycemic excursion']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0452712', 'cui_str': 'White rice (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C1258093', 'cui_str': 'Natto'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0032500', 'cui_str': 'L-Glutamic acid, homopolymer'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C1258093', 'cui_str': 'Natto'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0203502,"The blood glucose's IAUC at 0-15, 0-30, and 0-45 min was lower for the high-γ-PGA natto meal than for the low-γ-PGA natto meal (all  p  < 0.05).","[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Araki', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujie', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Yuine', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Watabe', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Internal Medicine (Endocrinology and Metabolism), Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}]",Nutrients,['10.3390/nu12040915']
570,31619413,Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.,"INTRODUCTION


A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer.
METHODS


We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events.
ETHICS AND DISSEMINATION


The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.
TRIAL REGISTRATION NUMBER


NCT02603341.",2019,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","['patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes', 'patients with non-metastatic breast cancer', '1278 patients with non-metastatic breast cancer', 'patients with breast cancer']","['proton versus photon therapy', 'proton therapy', 'photon or proton therapy', 'Radiotherapy Comparative Effectiveness (RadComp', 'Radiation therapy']","['major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease', 'cardiac morbidity and mortality', 'cancer recurrence and extending survival', 'urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0265122', 'cui_str': 'Disorder of pericardium (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}]",1278.0,0.145815,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","[{'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA bekelman@upenn.edu.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'American College of Radiology, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kaysee', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Berg', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amy Berrington', 'Initials': 'AB', 'LastName': 'de Gonzalez', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lior Z', 'Initials': 'LZ', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chauhan', 'Affiliation': 'Mayo Clinic Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'L Christine', 'Initials': 'LC', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Freedman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hahn', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jimenez', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Kesslering', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Cardio-Oncology Program, Division of Cardiovascular Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Choonsik', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hsiao-Ming', 'Initials': 'HM', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Mullins', 'Affiliation': 'PHSR, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Nagda', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pankuch', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Powell', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Fred W', 'Initials': 'FW', 'LastName': 'Prior', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schupak', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Alphonse G', 'Initials': 'AG', 'LastName': 'Taghian', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'J Ben', 'Initials': 'JB', 'LastName': 'Wilkinson', 'Affiliation': 'Provision Proton Therapy Center, Knoxville, Tennessee, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Cahlon', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025556']
571,32227432,Empagliflozin reduces the risk of mortality and hospitalization for heart failure across Thrombolysis In Myocardial Infarction Risk Score for Heart Failure in Diabetes categories: Post hoc analysis of the EMPA-REG OUTCOME trial.,"AIM


To investigate the association of the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Heart Failure in Diabetes (TRS-HF DM  ) with mortality using data from the EMPA-REG OUTCOME trial.
MATERIALS AND METHODS


In EMPA-REG OUTCOME, patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020) received the sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25 mg or placebo. Post hoc, patients were stratified into risk categories (low-intermediate, high, very-high risk scores) using baseline TRS-HF DM  . Cox regression analyses evaluated the association of TRS-HF DM  categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF, and whether empagliflozin reduced the risk of CV outcomes across these risk categories.
RESULTS


In placebo patients, increasing risk category was associated with a higher risk of ACM, CV death, and HHF. Empagliflozin reduced the risk of ACM (low-intermediate HR 0.68 [95% CI 0.48, 0.97] and very-high 0.69 [0.52, 0.91]), CV death (0.75 [0.48, 1.18] and 0.56 [0.41, 0.78]), HHF (0.53 [0.28, 1.01] and 0.67 [0.48, 0.96]), and CV death or HHF (0.69 [0.46, 1.03]) and (0.64 [0.49, 0.82]) across all risk categories versus placebo. Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
CONCLUSIONS


Applied to EMPA-REG OUTCOME, higher TRS-HF DM  was associated with increased HHF and mortality risk. Empagliflozin reduced CV outcomes across TRS-HF DM  categories. Higher ARRs were associated with higher risk scores.",2020,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
","['patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020', 'Heart Failure in Diabetes categories', 'Diabetes']","['Empagliflozin', 'placebo', 'Thrombolysis', 'sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25\u2009mg or placebo', 'empagliflozin']","['risk of CV outcomes', 'CV death', 'HHF and mortality risk', 'Myocardial Infarction (TIMI', 'HHF', 'higher risk of ACM, CV death, and HHF', 'risk of mortality and hospitalization for heart failure across Thrombolysis', 'CV death or HHF', 'TRS-HF DM  categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF', 'risk of ACM', 'Higher absolute risk reductions (ARRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.169317,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14015']
572,31899552,Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.,"BACKGROUND


Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT.
METHODS


We conducted an unblinded, randomized trial of a psychosocial intervention (BMT-CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT-CARE or usual care. BMT-CARE was tailored to the HCT trajectory and integrated treatment-related education and self-care with cognitive-behavioral skills to promote coping. Caregivers assigned to BMT-CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT-CARE on outcomes longitudinally.
RESULTS


We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = -2.18; 95% CI, -3.07 to -1.28; P < .001) and depression symptoms (B = -1.23; 95% CI, -1.92 to -0.54; P < .001), and improved self-efficacy (B = 7.22; 95% CI, 2.40-12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04-6.94; P < .001) in comparison with the usual-care group.
CONCLUSIONS


A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self-efficacy while reducing the caregiving burden during the acute HCT period.",2020,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","['Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience', 'We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions', 'caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital', 'family caregivers of patients undergoing hematopoietic stem cell transplantation', 'caregivers of HCT recipients']","['Multimodal psychosocial intervention', 'psychosocial intervention (BMT-CARE', 'BMT-CARE', 'trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing', 'BMT-CARE or usual care']","['QOL', 'reduced caregiving burden', 'coping skills', 'self-efficacy', 'QOL, mood, coping, and self-efficacy', 'caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status', 'lower anxiety', 'depression symptoms']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0222045'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.165701,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Showly', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Waldman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Fenech', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""D'Alotto"", 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horick', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spitzer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Zachariah', 'Initials': 'Z', 'LastName': 'DeFilipp', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Yi-Bin A', 'Initials': 'YA', 'LastName': 'Chen', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32680']
573,31764725,Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.,"OBJECTIVE


To estimate the effect of oral opioids on patient pain during first-trimester medical abortion.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial where patients up to 10 0/7 weeks of gestation undergoing a medical abortion with mifepristone and misoprostol took 10 mg oral oxycodone or placebo at onset of painful cramping. Additionally, all patients received 800-mg ibuprofen tablets, 4-mg ondansetron oral dissolving tablets, and a written prescription for adjunctive pain medication (six tablets oxycodone 5 mg). Participants used a text-messaging service to report pain scores on a numerical rating scale from 0 to 10 (0 being no pain, 10 being worst pain) for 24 hours at start of misoprostol dosing. The primary outcome was maximum pain experienced within 24 hours postmisoprostol. Our secondary outcomes were maximum pain stratified by gestational age (less than 7 weeks of gestation, 7-10 weeks of gestation), duration of maximum pain, use of adjunctive medication, presence of nausea or vomiting, and satisfaction. We needed at least 76 participants per group to differentiate a clinically important pain difference of 2 points on the numerical rating scale.
RESULTS


From May 2017 to May 2018, we randomized 172 participants (placebo group with 86, oxycodone group with 86). The study groups had comparable baseline characteristics. We found no difference between groups in median maximum pain scores (placebo 8 [range 1-10], oxycodone 8 [range 2-10], P=.92) and the median duration of maximum pain (placebo 0.75 hours range 0.01-15 vs oxycodone 1 hour range 0.02-10, P=.39). Groups were also similar in the proportion obtaining (placebo 62%, oxycodone 49%, P=.09) and using (placebo 48%, oxycodone 40%, P=.28) adjunctive medication, experiencing nausea or vomiting (placebo 59%, oxycodone 65%, P=.43) and reported satisfaction with pain medications (placebo 62%, oxycodone 65%, P=.63).
CONCLUSION


Oxycodone does not reduce the maximum level of pain experienced by women undergoing medical abortion up to 10 0/7 weeks of gestation or improve satisfaction.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03139240.",2019,"Groups were also similar in the proportion obtaining (placebo 62%, oxycodone 49%, P=.09) and using (placebo 48%, oxycodone 40%, P=.28) adjunctive medication, experiencing nausea or vomiting (placebo 59%, oxycodone 65%, P=.43) and reported satisfaction with pain medications (placebo 62%, oxycodone 65%, P=.63).
","['at onset of painful cramping', '172 participants (placebo group with 86, oxycodone group with 86', 'Medical Abortion', 'patients up to 10 0/7 weeks of gestation undergoing a medical abortion with']","['oral opioids', 'placebo', '800-mg ibuprofen tablets, 4-mg ondansetron oral dissolving tablets', 'Oxycodone', 'Opioid Analgesia', 'mifepristone and misoprostol took 10 mg oral oxycodone or placebo']","['maximum pain experienced within 24 hours postmisoprostol', 'adjunctive medication, experiencing nausea or vomiting', 'satisfaction with pain medications', 'duration of maximum pain, use of adjunctive medication, presence of nausea or vomiting, and satisfaction', 'maximum level of pain', 'patient pain', 'median duration of maximum pain', 'maximum pain stratified by gestational age', 'numerical rating scale', 'median maximum pain scores']","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C3146283', 'cui_str': 'Medical abortion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C4521688', 'cui_str': 'Dissolve (transformation)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",172.0,0.82578,"Groups were also similar in the proportion obtaining (placebo 62%, oxycodone 49%, P=.09) and using (placebo 48%, oxycodone 40%, P=.28) adjunctive medication, experiencing nausea or vomiting (placebo 59%, oxycodone 65%, P=.43) and reported satisfaction with pain medications (placebo 62%, oxycodone 65%, P=.63).
","[{'ForeName': 'Alyssa Covelli', 'Initials': 'AC', 'LastName': 'Colwill', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Bayer', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bednarek', 'Affiliation': ''}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Jeffery T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003576']
574,31764727,Expedited Scheduling of Interval Tubal Ligation: A Randomized Controlled Trial.,"OBJECTIVE


To assess whether expedited scheduling for permanent contraception increases the proportion of patients completing interval tubal ligation within 6 months of delivery.
METHODS


We randomly assigned patients with unfulfilled immediate postpartum tubal ligation requests to standard scheduling after a postpartum office visit or an expedited process in which we scheduled the interval tubal ligation surgery before discharge from the hospital. The primary outcome was proportion of participants undergoing tubal contraceptive procedures within 6 months of delivery. Secondary outcomes included patient satisfaction with the scheduling process, repeat pregnancy rates, and surgical outcomes. We estimated that 122 patients (61 per group) would provide greater than 80% power to identify a 25% difference favoring expedited scheduling in the primary outcome (one-sided α of 0.05).
RESULTS


Between September 2016 and June 2018, 239 patients requested tubal ligation at the time of delivery; 155 were not completed. Of these, 126 patients were eligible for the study. We stopped the study at the prespecified 50% enrollment point after 67 patients enrolled, with 34 and 33 assigned to the standard and expedited arms, respectively. Fifteen participants in the expedited group, and two in the standard group completed tubal ligation within 6 months (50% vs 9%; odds ratio 10.0, CI 2.0-50.2). Delivery-to-surgery interval was 49 days in the expedited group, compared with 121 days in the standard group (P=.05). Seventeen participants in the expedited group and three in the standard group reported being very satisfied with the scheduling process (57% vs 13%, P=.03). The only two interim pregnancies both occurred in the standard group (P=.09). There were no surgical complications in any of the 17 completed tubal procedures.
CONCLUSION


Expedited scheduling significantly improves tubal contraceptive surgery completion and patient satisfaction. Laparoscopic or hysteroscopic tubal ligation or salpingectomy can be performed 4-6 weeks after delivery with minimal interval outpatient follow-up.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02875483.",2019,"Delivery-to-surgery interval was 49 days in the expedited group, compared with 121 days in the standard group (P=.05).","['239 patients requested tubal ligation at the time of delivery; 155 were not completed', '126 patients were eligible for the study', '67 patients enrolled, with 34 and 33 assigned to the standard and expedited arms, respectively', 'Between September 2016 and June 2018', 'patients completing interval tubal ligation within 6 months of delivery']","['Laparoscopic or hysteroscopic tubal ligation or salpingectomy', 'Interval Tubal Ligation', 'unfulfilled immediate postpartum tubal ligation requests to standard scheduling after a postpartum office visit or an expedited process in which we scheduled the interval tubal ligation surgery before discharge from the hospital']","['tubal contraceptive surgery completion and patient satisfaction', 'proportion of participants undergoing tubal contraceptive procedures within 6 months of delivery', 'patient satisfaction with the scheduling process, repeat pregnancy rates, and surgical outcomes', 'tubal ligation', 'surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C1444661', 'cui_str': 'Not completed'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C0041271', 'cui_str': 'Tubectomy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",17.0,0.303707,"Delivery-to-surgery interval was 49 days in the expedited group, compared with 121 days in the standard group (P=.05).","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Mercier', 'Affiliation': 'Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, and the Department of Obstetrics and Gynecology, Einstein Healthcare Network, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Perriera', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Godcharles', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Shaber', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003550']
575,31764732,Ibuprofen and Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effect of ibuprofen on blood pressure in women with a diagnosis of hypertensive disorders of pregnancy and mild hypertension during the immediate postpartum period.
METHODS


In this double-blind controlled trial, we randomly assigned women with a diagnosis of hypertensive disorders of pregnancy and mild hypertension to receive a postpartum analgesic regimen with either ibuprofen or acetaminophen. The primary outcome was average mean arterial pressure during the postpartum hospital stay. Prespecified secondary outcomes included use of breakthrough opioid pain medications, length of hospital stay, and postpartum diuresis, defined as urine output of at least 200 mL/hour for 4 hours. A sample size of 56 participants was needed to detect a difference of 6 mm Hg in average mean arterial pressure between the study groups.
RESULTS


From January 17, 2017, to February 24, 2018, 61 participants were randomized and completed the trial, 31 participants in the ibuprofen group and 30 in the control group. Baseline characteristics were similar between groups. Postpartum average arterial pressure did not differ between study groups (93±8 mm Hg for those in the ibuprofen group vs 93±7 mm Hg in the control group, P=.93). Breakthrough opioid medications were requested by 24% of the participants in the ibuprofen group compared with 30% in the control group (P=.62). The ibuprofen group did not have a longer length of stay (48 hours vs 43 hours in the control group) or decreased rate of postpartum diuresis (61% in ibuprofen group vs 77% in the control group, P=.2).
CONCLUSION


In women with hypertensive disorders of pregnancy and mild hypertension, ibuprofen did not increase postpartum blood pressure compared with women not receiving nonsteroidal antiinflammatory drugs.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03011567.",2019,"The ibuprofen group did not have a longer length of stay (48 hours vs 43 hours in the control group) or decreased rate of postpartum diuresis (61% in ibuprofen group vs 77% in the control group, P=.2).
","['56 participants was needed to detect a difference of 6 mm Hg in average mean arterial pressure between the study groups', 'women with hypertensive disorders of pregnancy and mild hypertension', 'randomly assigned women with a diagnosis of hypertensive disorders of pregnancy and mild hypertension to receive a postpartum analgesic regimen with either', 'From January 17, 2017, to February 24, 2018, 61 participants were randomized and completed the trial, 31 participants in the ibuprofen group and 30 in the control group', 'Women With Hypertensive Disorders of Pregnancy', 'women with a diagnosis of hypertensive disorders of pregnancy and mild hypertension during the immediate postpartum period']","['ibuprofen', 'Ibuprofen', 'ibuprofen or acetaminophen']","['blood pressure', 'Breakthrough opioid medications', 'average mean arterial pressure during the postpartum hospital stay', 'Postpartum average arterial pressure', 'longer length of stay', 'postpartum blood pressure', 'breakthrough opioid pain medications, length of hospital stay, and postpartum diuresis, defined as urine output of at least 200 mL/hour for 4 hours', 'rate of postpartum diuresis']","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}]",61.0,0.391974,"The ibuprofen group did not have a longer length of stay (48 hours vs 43 hours in the control group) or decreased rate of postpartum diuresis (61% in ibuprofen group vs 77% in the control group, P=.2).
","[{'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Penfield', 'Affiliation': ""Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Irvine, and the Department of Obstetrics and Gynecology, Miller Children's and Women's Hospital/Long Beach Memorial Medical Center, Long Beach, California.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Oakes', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Nageotte', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003553']
576,31764741,Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial.,"OBJECTIVE


To compare pain after robotic-assisted laparoscopic hysterectomy when giving preoperative oral compared with intravenous acetaminophen.
METHODS


This double-blind randomized trial included women undergoing robotic-assisted laparoscopic hysterectomy for benign indications. Participants received either acetaminophen 1 g orally then normal saline 100 mL intravenously before surgery, or a placebo orally then acetaminophen 1 g intravenously. The primary outcome measured was difference in pain between the groups 2 hours postoperatively. A sample size of 74 participants (37/group) was needed to achieve 80% power to detect noninferiority using a one-sided, two-sample t-test with an alpha of 0.025 and a noninferiority margin of 10 mm.
RESULTS


From April 2016 through August 2017, 77 patients were enrolled, with 75 participants included in the final analysis. Characteristics were similar between groups. No difference in average pain score was noted 2 hours after surgery, nor at any of the measured time points. Average scores for the oral and intravenous group, respectively, at 2 hours were 35 and 36 mm (P=.86), at 4 hours 36 and 37 mm (P=.96), and at 24 hours 35 and 36 mm (P=.79). Thirty-eight percent of participants in the oral group and 19% of participants in the intravenous group experienced nausea (P=.12). The oral group used 9.7 morphine equivalents in the recovery room, and the intravenous group used 9.5 morphine equivalents (P=.9). The oral group requested analgesia in 45 minutes on average, and the intravenous group requested analgesia in 43 minutes (P=.79).
CONCLUSION


No difference in pain was observed 2 hours postoperatively when comparing preoperative administration of oral compared with intravenous acetaminophen. Given the ease of administration and lower cost of oral dosing, this study supports the oral route as part of the enhanced recovery after surgery protocol for minimally invasive gynecologic surgery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03391284.",2019,"Average scores for the oral and intravenous group, respectively, at 2 hours were 35 and 36 mm (P=.86), at 4 hours 36 and 37 mm (P=.96), and at 24 hours 35 and 36 mm (P=.79).","['From April 2016 through August 2017, 77 patients were enrolled, with 75 participants included in the final analysis', '74 participants (37/group', 'women undergoing']","['Robotic-Assisted Laparoscopic Hysterectomy', 'Preemptive Oral Compared With Intravenous Acetaminophen', 'acetaminophen', 'acetaminophen 1 g orally then normal saline 100 mL intravenously before surgery, or a placebo orally then acetaminophen', 'robotic-assisted laparoscopic hysterectomy']","['pain', 'Average scores', 'average pain score', 'Postoperative Pain', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",74.0,0.609066,"Average scores for the oral and intravenous group, respectively, at 2 hours were 35 and 36 mm (P=.86), at 4 hours 36 and 37 mm (P=.96), and at 24 hours 35 and 36 mm (P=.79).","[{'ForeName': 'Tresa M', 'Initials': 'TM', 'LastName': 'Lombardi', 'Affiliation': 'Departments of Obstetrics and Gynecology and Pharmacy, Scripps Memorial Hospital La Jolla, and Scripps Research Translational Institute, San Diego, California.'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Lily J', 'Initials': 'LJ', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Waalen', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wachi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003578']
577,32232659,Continuous quadratus lumborum block and femoral nerve block for total hip arthroplasty: a randomized study.,"BACKGROUND


Continuous femoral nerve block (FNB) has been effectively used after total hip arthroplasty (THA). Recently the anterior approach to quadratus lumborum block (QLB) has been shown to produce postoperative pain relief after THA. Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB. In this randomized controlled study, we compared analgesic effects of the two techniques in patients undergoing THA.
METHODS


Thirty patients undergoing THA were randomly allocated into two groups receiving continuous QLB and FNB. Under ultrasound guidance, QLB and FNB were conducted before general anesthesia using 0.25% levobupivacaine 30 ml and 0.5% levobupivacaine 15 ml, respectively, and a catheter was introduced. Postoperatively, all patients received continuous infusion of 0.125% levobupivacaine at 4 ml/h. Postoperative measurements included visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48 h.
RESULTS


Six patients were excluded and 24 patients (13 and 11 patients in QLB group and FNB, respectively) were analyzed. VAS scores on movement at 6 h [median (IQR): 67 (41-80) and 38 (22-41) in QLB and FNB groups, respectively, p = 0.008] and 24 h [60 (40-80) and 39 (28-64) in QLB and FNB groups, respectively, p = 0.018] were lower with FNB than with QLB. QLB did not produce consistent cutaneous sensory blockade.
CONCLUSIONS


Analgesic effects of continuous QLB were inferior to those of continuous FNB in patients undergoing THA under the current study condition.",2020,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"['Thirty patients undergoing THA', 'total hip arthroplasty', 'patients undergoing THA', 'patients undergoing THA under the current study condition']","['continuous infusion of 0.125% levobupivacaine', 'Continuous quadratus lumborum block and femoral nerve block', 'Continuous femoral nerve block (FNB', 'QLB', 'continuous QLB and FNB', 'levobupivacaine 30\xa0ml and 0.5% levobupivacaine']","['visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48\xa0h', 'VAS scores on movement at 6\xa0h [median (IQR']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",30.0,0.123723,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan. ssakura@med.shimane-u.ac.jp.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Tadenuma', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02769-9']
578,31526276,Implementation of the FIFA 11+ Injury Prevention Program by High School Athletic Teams Did Not Reduce Lower Extremity Injuries: A Cluster Randomized Controlled Trial.,"BACKGROUND


Lower extremity injuries are common in high school sports and are costly, and some have poor outcomes. The FIFA 11+ injury prevention program has been shown to decrease injuries in elite athletes by up to 72%.
HYPOTHESIS


High schools in which coaches implement the FIFA 11+ injury prevention program in their athletic programs will have a decreased incidence of lower extremity injuries compared with schools using their usual prepractice warm-up.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Fourteen high schools that employed an athletic trainer were randomly assigned to either the FIFA 11+ group or control group (usual warm-up routine). Exposure to sports and injuries were recorded and used to determine the incidence rates of lower extremity injuries per athlete-exposure (AE). The FIFA 11+ program was implemented by coaches and complicance with the program recorded.
RESULTS


There were 196 lower extremity injuries among 1825 athletes in the FIFA 11+ group and 172 injuries among 1786 athletes in the control group (1.59 and 1.47 injuries per 1000 AEs, respectively;  P  = .771). The distribution of the types of injury in the 2 groups did not differ, but the body locations where the injuries occurred differed somewhat ( P  = .051). The FIFA 11+ group had larger proportions of thigh and foot injuries, while the control group had higher proportions of knee and ankle injuries. Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex. In the FIFA 11+ group, 62% of the coaches reported that their teams completed the full FIFA 11+ program at least once a week, and 32% reported that they completed it at least twice a week.
CONCLUSION


This study did not demonstrate a reduction in lower extremity injuries in schools randomized to use the FIFA 11+ program compared with schools using their usual prepractice warm-up program. Coach-reported compliance with performing the FIFA 11+ program at least twice a week was low.",2019,"Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex.",['Fourteen high schools that employed an athletic trainer'],"['FIFA 11+ Injury Prevention Program', 'FIFA 11+ group or control group (usual warm-up routine']","['Extremity Injuries', 'larger proportions of thigh and foot injuries', 'injury rates', 'proportions of knee and ankle injuries', 'extremity injuries']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0149697', 'cui_str': 'Foot Injuries'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0085111', 'cui_str': 'Ankle Injuries'}]",196.0,0.0275468,"Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Slauterbeck', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Choquette', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Mickey', 'Initials': 'M', 'LastName': 'Krug', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bert R', 'Initials': 'BR', 'LastName': 'Mandelbaum', 'Affiliation': 'Cedars-Sinai Kerlan-Jobe Institute, Santa Monica, California, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vacek', 'Affiliation': 'Department of Medical Biostatistics, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Beynnon', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}]",The American journal of sports medicine,['10.1177/0363546519873270']
579,31863189,Prophylactic diphenhydramine attenuates postoperative catheter-related bladder discomfort in patients undergoing gynecologic laparoscopic surgery: a randomized double-blind clinical study.,"BACKGROUND


To evaluate the effectiveness of diphenhydramine, an antihistamine with anti-muscarinic properties, for prevention of postoperative catheter-related bladder discomfort (CRBD).
METHODS


Ninety-six ASA physical status I and II adult female patients (20-60 years) scheduled for elective gynecologic laparoscopic surgery were included. Patients were randomized into two groups of 48 patients each. All patients received a detailed preoperative explanation of the possible consequences of CRBD. The control group received normal saline 2 ml, whereas the diphenhydramine group received diphenhydramine 30 mg intravenously after induction of general anesthesia. Then, all patients were catheterized with a 14F Foley catheter and the balloon was inflated with 10 ml of distilled water. All patients who complained of CRBD in the postoperative room were appeased with nursing. Ketorolac 30 mg was used as the rescue drug on patients' request or when the patient was evaluated as having moderate or severe CRBD. Bladder discomfort and its severity were assessed at 1, 2 and 6 h postoperatively. The severity of CRBD was graded as none, mild, moderate and severe. Adverse effects of diphenhydramine such as sedation, dry mouth or GI upset were recorded.
RESULTS


The incidence of CRBD was lower in the diphenhydramine group compared with the control group at 2 h (34.8 vs. 58.7%, p = 0.02) and 6 h (23.9 vs. 56.5%, p < 0.01) postoperatively. Diphenhydramine treatment also reduced the severity of CRBD at 6 h postoperatively (p = 0.01). Moreover, the request for rescue for CRBD was lower in diphenhydramine group at 2 h (8.7 vs. 26.1%, p = 0.03). There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
CONCLUSION


Prophylactic diphenhydramine 30 mg at induction of general anesthesia reduced the incidence and severity of postoperative bladder discomfort without significant side effects in patients receiving gynecologic laparoscopic surgery.",2020,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","['patients undergoing gynecologic laparoscopic surgery', 'Ninety-six ASA physical status', 'patients receiving gynecologic laparoscopic surgery', 'All patients who complained of CRBD in the postoperative room were appeased with nursing', 'I and II adult female patients (20-60\xa0years) scheduled for']","['Ketorolac', '14F Foley catheter and the balloon was inflated with 10\xa0ml of distilled water', 'Prophylactic diphenhydramine', 'normal saline 2\xa0ml', 'elective gynecologic laparoscopic surgery', 'diphenhydramine 30\xa0mg intravenously after induction of general anesthesia', 'diphenhydramine', 'Diphenhydramine']","['severity of CRBD', 'side effects, such as sedation, dry mouth or gastrointestinal upset', 'incidence of CRBD', 'Bladder discomfort and its severity', 'sedation, dry mouth or GI upset', 'request for rescue for CRBD', 'postoperative catheter-related bladder discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0179804'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",96.0,0.160389,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","[{'ForeName': 'Yu-Yu', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Yan-Syun', 'Initials': 'YS', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jen-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Kuei-Fen', 'Initials': 'KF', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chung-Hsi', 'Initials': 'CH', 'LastName': 'Hsing', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Wen-Ju', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jhi-Joung', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Ping-Hsun', 'Initials': 'PH', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chin-Chen', 'Initials': 'CC', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan. chinchen.chu@gmail.com.'}]",Journal of anesthesia,['10.1007/s00540-019-02724-3']
580,32095875,Comparison of interlaminar CT-guided epidural platelet-rich plasma versus steroid injection in patients with lumbar radicular pain.,"INTRODUCTION


The treatment of persistent lumbar radicular pain (LRP) by CT-guided epidural steroid injection (ESI) is extensively used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to favor healing and the anti-inflammatory process by delivering growth factors and cytokines, might be an alternative and potentially safer option. We compared the efficacy of interlaminar CT-guided epidural PRP injections (EPRPI) and ESI in the treatment of persistent LRP (> 6 weeks).
METHODS


In this non-randomized comparative study, patients were prospectively assessed for pain using the numerical rating scale (NRS) and for function with the Oswestry Disability Index (ODI) before and 6 weeks after treatment. Related paired and independent t tests were used for intra- and inter-group comparisons.
RESULTS


A total of 60 patients were included in 2 groups (n = 30 EPRPI, n = 30 ESI). A statistically significant improvement was found in both groups at 6 weeks (mean NRS values 5.7 (± 2.36) at D0 and 3.7 (± 2.3) at 6 weeks (p < 0.01); mean ODI values 30 (± 11) at D0 and 21 (± 13) at 6 weeks (p < 0.01)). No significant difference was observed in the decrease in NRS and ODI scores between the 2 groups at 6 weeks (p = 0.848 and p = 0.314 for the NRS and ODI, respectively). No major complications were noted.
CONCLUSION


The results of CT-guided interlaminar EPRPI are similar to ESI for the treatment of persistent LRP and could be a safer option.
KEY POINTS


• Treatment of persistent lumbar radicular pain by CT-guided epidural steroid injections is associated with rare but serious complications. • By promoting an anti-inflammatory process, epidural platelet-rich plasma injections might be an alternative treatment of persistent radicular pain. • Platelet-rich plasma CT-guided epidural injections are similar to steroid for the treatment of lumbar radicular pain at 6 weeks post-procedure and could be a safer option.",2020,"No significant difference was observed in the decrease in NRS and ODI scores between the 2 groups at 6 weeks (p = 0.848 and p = 0.314 for the NRS and ODI, respectively).","['patients with lumbar radicular pain', '60 patients were included in 2 groups (n\u2009=\u200930 EPRPI, n\u2009=\u200930 ESI']","['CT-guided epidural steroid injections', 'interlaminar CT-guided epidural platelet-rich plasma versus steroid injection', 'interlaminar CT-guided epidural PRP injections (EPRPI) and ESI', 'Platelet-rich plasma (PRP', 'CT-guided epidural steroid injection (ESI']","['pain using the numerical rating scale (NRS) and for function with the Oswestry Disability Index (ODI', 'NRS and ODI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection (procedure)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0252996,"No significant difference was observed in the decrease in NRS and ODI scores between the 2 groups at 6 weeks (p = 0.848 and p = 0.314 for the NRS and ODI, respectively).","[{'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Bise', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France. sylvainbise@gmail.com.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dallaudiere', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Pesquer', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France.""}, {'ForeName': 'Morad', 'Initials': 'M', 'LastName': 'Pedram', 'Affiliation': 'Centre aquitain du dos, Clinique du sport de Bordeaux, 2 rue Georges-Negrevergne, 33700, Mérignac, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Meyer', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France.""}, {'ForeName': 'Myriame Bou', 'Initials': 'MB', 'LastName': 'Antoun', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Hocquelet', 'Affiliation': ""Service de radiologie et d'imagerie diagnostique et interventionnelle, CHU Vaudois, 1011, Lausanne, Switzerland.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Silvestre', 'Affiliation': ""Centre d'imagerie ostéo-articulaire, Clinique du sport, 2 rue Georges-Negrevergne, 33700, Mérignac, France.""}]",European radiology,['10.1007/s00330-020-06733-9']
581,32199338,Split Skin Graft Take in Leg Ulcers: Conventional Dressing Versus Locally Adapted Negative Pressure Dressing.,"BACKGROUND


Split-thickness skin grafting is widely used in the management of leg ulcers but is fraught with suboptimal take especially in less than ideal wound beds. The use of negative pressure dressing to prepare wound beds is an established practice. However, its use to improve graft survival is yet to be a common practice. We aim to compare quantitative and qualitative split thickness skin graft take in leg and foot ulcers using either traditional wound dressing or negative pressure dressing methods.
METHODS


Sixty-two cases were recruited for the study and assigned into two groups of 31 cases each by convenient sampling method. Group A patients had negative pressure dressings in both phases, whereas group B patients had traditional wound dressing in both phases. The percentage skin graft take for both groups, and the pattern of complications were assessed. Results were analyzed using IBM SPSS statistics for windows (version 21.0; IBM Corp, Armonk, NY). Student t-test was used to compare the percentage graft take, whereas Chi-square was used to compare significance of complications in both dressing methods.
RESULTS


The negative pressure dressing showed better skin graft take with mean value of 99.2 ± 0.95% compared with traditional dressing with mean take of 89.7 ± 6.44%, which was statistically significant with a P value of <0.001. The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing. This is statistically significant with a P value < 0.001.
CONCLUSIONS


Negative pressure dressing for split-thickness skin graft contributes significantly to improved split-thickness skin graft take with reduced complication rate as compared with conventional wound dressing method.",2020,"The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing.","['Leg Ulcers', 'Sixty-two cases were recruited for the study and assigned into two groups of 31 cases each by convenient sampling method']","['Conventional Dressing Versus Locally Adapted Negative Pressure Dressing', 'negative pressure dressing', 'Split Skin Graft Take', 'traditional wound dressing or negative pressure dressing methods']","['IBM SPSS statistics', 'percentage skin graft take', 'negative pressure dressings', 'graft survival', 'complication rate', 'traditional wound dressing']","[{'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]",62.0,0.0349129,"The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing.","[{'ForeName': 'Charles Chidiebele', 'Initials': 'CC', 'LastName': 'Maduba', 'Affiliation': 'Department of Surgery, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria. Electronic address: charlesmaduba@gmail.com.'}, {'ForeName': 'Ugochukwu Uzodimma', 'Initials': 'UU', 'LastName': 'Nnadozie', 'Affiliation': 'Department of Surgery, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria; Department of Surgery, Ebonyi State University, Abakaliki, Nigeria.'}, {'ForeName': 'Victor Ifeanyichukwu', 'Initials': 'VI', 'LastName': 'Modekwe', 'Affiliation': 'Division of Paediatric Surgery, Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'Ifeanyichukwu Igwilo', 'Initials': 'II', 'LastName': 'Onah', 'Affiliation': 'Department of Plastic Surgery, National Orthopaedic Hospital, Enugu, Nigeria.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.029']
582,31387158,Nasal high flow does not improve exercise tolerance in COPD patients recovering from acute exacerbation: A randomized crossover study.,"BACKGROUND AND OBJECTIVE


We hypothesized that by reducing respiratory work and improving gas exchange, nasal high flow (NHF) would improve exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) following respiratory exacerbation.
METHODS


This was a monocentric, randomized, controlled crossover study. Patients with severe to very severe COPD carried out two high-intensity constant work-rate exercise tests (CWRET) with and without NHF on two consecutive days. The primary outcome was the mean difference in endurance time between both conditions. The secondary aims included vastus lateralis oxygenation (StO 2  ), dyspnoea, leg discomfort, maximal inspiratory pressure (MIP), transcutaneous CO 2  pressure (PtcCO 2  ), respiratory rate (RR), heart rate (HR) and pulsed O 2  saturation (SpO 2  ), as well as the patients' opinions of the device.
RESULTS


A total of 19 patients were included (mean forced expiratory volume in 1 s = 28.7 ± 10.8%, age = 62.1 ± 9.1 years). No significant differences in endurance time during the CWRET were found between the two test conditions (-66.58 (95% CI: -155.9 to 22.7) s, P = 0.12). StO 2  , PtCO 2  and HR were reduced at the end of the exercise with NHF (-2.1% (95% CI: -4.3 to -0.0); -1.3 mm Hg (95% CI: -2.5 to -0.2); -2.7 bpm (95% CI: -5.0 to -0.5), respectively, P ≤ 0.05). No significant differences were found for any of the other secondary outcomes. Half of the patients evaluated the device as being moderately to very uncomfortable.
CONCLUSION


NHF during exercise did not increase endurance time in patients with COPD following exacerbation.
CLINICAL TRIAL REGISTRATION


NCT03058081 at clinicaltrials.gov.",2019,No significant differences in endurance time during the CWRET were found between the two test conditions (-66.58,"['A total of 19 patients were included (mean forced expiratory volume in 1\u2009s = 28.7\u2009±\u200910.8%, age = 62.1\u2009±\u20099.1 years', 'patients with chronic obstructive pulmonary disease (COPD) following respiratory exacerbation', 'Patients with severe to very severe COPD', 'patients with COPD following exacerbation', 'COPD patients recovering from acute exacerbation']","['gas exchange, nasal high flow (NHF', 'NHF']","['endurance time', ""vastus lateralis oxygenation (StO 2  ), dyspnoea, leg discomfort, maximal inspiratory pressure (MIP), transcutaneous CO 2  pressure (PtcCO 2  ), respiratory rate (RR), heart rate (HR) and pulsed O 2  saturation (SpO 2  ), as well as the patients' opinions of the device"", 'mean difference in endurance time', 'StO 2  , PtCO 2  and HR', 'exercise tolerance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0859235', 'cui_str': 'Lower extremities ill feeling of'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",,0.350518,No significant differences in endurance time during the CWRET were found between the two test conditions (-66.58,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL and Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie University, UNIROUEN, Rouen, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL and Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dupuis Lozeron', 'Affiliation': 'Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie University, UNIROUEN, Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie University, UNIROUEN, Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Quieffin', 'Affiliation': 'Pulmonology Department, Groupe Hospitalier du Havre, Montivilliers, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie University, UNIROUEN, Rouen, France.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'Association AGIR à dom, Research and Development, Meylan, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL and Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, Brussels, Belgium.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13664']
583,31977576,The effects of antihypertensive class on gout in older adults: secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.,"OBJECTIVES


Gout is a common complication of blood pressure management and a frequently cited cause of medication nonadherence. Little trial evidence exists to inform antihypertensive selection with regard to gout risk.
METHODS


The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) was a randomized clinical trial on the effects of first-step hypertension therapy with amlodipine, chlorthalidone, or lisinopril on fatal coronary heart disease or nonfatal myocardial infarction (1994-2002). Trial participants were linked to CMS and VA gout claims (ICD9 274.XX). We determined the effect of drug assignment on gout with Cox regression models. We also determined the adjusted association of self-reported atenolol use (ascertained at the 1-month visit for indications other than hypertension) with gout.
RESULTS


Claims were linked to 23 964 participants (mean age 69.8 ± 6.8 years, 45% women, 31% black). Atenolol use was reported by 928 participants at the 1-month visit. Over a mean follow-up of 4.9 years, we documented 597 gout claims. Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril. Lisinopril nonsignificantly lowered gout risk compared with chlorthalidone (hazard ratio 0.85; 95% CI 0.70--1.03). Atenolol use was not associated with gout risk (adjusted hazard ratio 1.18; 95% CI 0.78--1.80). Gout risk reduction was primarily observed after 1 year of follow-up.
CONCLUSION


Amlodipine lowered long-term gout risk compared with lisinopril or chlorthalidone. This finding may be useful in cases where gout risk is a principal concern among patients being treated for hypertension.This trial is registered at clinicaltrials.gov, number: NCT00000542.",2020,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"['Claims were linked to 23\u200a964 participants (mean age 69.8\u200a±\u200a6.8 years, 45% women, 31% black', 'older adults', '928 participants at the 1-month visit', 'patients being treated for hypertension']","['Lisinopril', 'amlodipine, chlorthalidone, or lisinopril', 'lisinopril', 'chlorthalidone', 'Amlodipine', 'lisinopril or chlorthalidone', 'Atenolol', 'antihypertensive class']","['risk of gout', 'fatal coronary heart disease or nonfatal myocardial infarction', 'Gout risk reduction', 'gout risk']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",23964.0,0.236379,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lara M', 'Initials': 'LM', 'LastName': 'Simpson', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shmerling', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beach', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ishak', 'Affiliation': 'Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Journal of hypertension,['10.1097/HJH.0000000000002359']
584,32233338,"A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.","BACKGROUND


Obesity is a chronic disease with limited treatment options in pediatric patients. Liraglutide may be useful for weight management in adolescents with obesity.
METHODS


In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide (3.0 mg) or placebo subcutaneously once daily, in addition to lifestyle therapy. The primary end point was the change from baseline in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score at week 56.
RESULTS


A total of 125 participants were assigned to the liraglutide group and 126 to the placebo group. Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 (estimated difference, -0.22; 95% confidence interval [CI], -0.37 to -0.08; P = 0.002). A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%). A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]). After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23). More participants in the liraglutide group than in the placebo group had gastrointestinal adverse events (81 of 125 [64.8%] vs. 46 of 126 [36.5%]) and adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0). Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]). One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.
CONCLUSIONS


In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle therapy. (Funded by Novo Nordisk; NN8022-4180 ClinicalTrials.gov number, NCT02918279.).",2020,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","['enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone', 'Adolescents with Obesity', 'pediatric patients', 'adolescents with obesity', 'A total of 125 participants']","['Liraglutide', 'liraglutide', 'placebo', 'placebo subcutaneously once daily, in addition to lifestyle therapy']","['body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score', 'BMI standard-deviation score', 'gastrointestinal adverse events', 'BMI', 'body weight', 'serious adverse events', 'adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",125.0,0.384518,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","[{'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Kelly', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Barrientos-Perez', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Gies', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hale', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Lucy D', 'Initials': 'LD', 'LastName': 'Mastrandrea', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Nandana', 'Initials': 'N', 'LastName': 'Prabhu', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916038']
585,32020373,Perseus A500 enables faster recovery from desflurane general anesthesia.,"PURPOSE


The Dräger Perseus A500 (Perseus) anesthetic workstation has been designed with a lower internal volume. We evaluated the recovery time following general anesthesia using the Perseus workstation compared with that using the conventional Dräger Fabius Plus workstation.
METHODS


Following approval by our institutional research ethics committee, 50 patients receiving elective surgery under general anesthesia were enrolled in the study. Written informed consent was obtained from each patient. The patients were divided into the Perseus group and a control group. The Perseus anesthesia workstation was used for the Perseus group, and the Fabius Plus was used for the control group. General anesthesia was maintained with a 4.2% end-tidal concentration of desflurane, remifentanil, fentanyl, and regional anesthesia. After the surgical procedure, the administration of desflurane was discontinued. The inspiratory and expiratory desflurane concentration, time taken for patients to open their eyes, and the time taken to extubate the trachea after discontinuation of anesthetics were recorded.
RESULTS


The inspiratory and expiratory desflurane concentration after the administration of desflurane was discontinued was lower in the Perseus group. Moreover, the time taken for patients to open their eyes was statistically significantly quicker in the Perseus group when compared with the control group: 284 ± 60 vs 325 ± 43 s, respectively. The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
CONCLUSIONS


We demonstrate in this study that Perseus enables the faster wash-out of anesthetics and faster recovery of patients after general anesthesia.",2020,"The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
",['50 patients receiving elective surgery under general anesthesia were enrolled in the study'],"['desflurane', 'desflurane, remifentanil, fentanyl, and regional anesthesia']","['inspiratory and expiratory desflurane concentration, time taken', 'time taken for extubation', 'recovery time', 'inspiratory and expiratory desflurane concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",,0.0161679,"The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan. yasumorimo@gmail.com.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Shiramoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Shimamoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02740-8']
586,32114213,Learning Intracorporeal Suture on Pelvitrainer Using a Robotized Versus Conventional Needle Holder.,"BACKGROUND


Laparoscopy is the gold standard approach in numerous surgical procedures. A new generation of robotized instruments has been developed to compensate for the ergonomic constraints of conventional instruments. The main objective was to compare the learning curves of novices for intracorporeal suturing on a laparoscopy pelvitrainer, using either a robotized needle holder or conventional needle holders. The post-training performances under ergonomically difficult conditions were also analyzed.
MATERIALS AND METHODS


Fifth-year medical students were randomized in group A using a robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders. They undertook four training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture).
RESULTS


Twenty participants were included. The performances of the two groups (n = 10) were not significantly different at baseline. During the training sessions, there was a learning curve with a plateau at the third session for both the groups. At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762). There was a significant difference between group A and group B for the frontal suture (median global score: 15.75 versus 3.75 respectively; P = 0.005) but not for the hexagonal suture (median global score: 18 versus 15 respectively; P = 0.284).
CONCLUSIONS


Learning curves were equally fast using the robotized needle holder versus conventional instruments and led to equivalent performances. Under ergonomically difficult conditions, the robotized needle holder provided an advantage relative to conventional instruments.",2020,"At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762).","['Fifth-year medical students', 'Twenty participants were included']","['robotized needle holder or conventional needle holders', 'training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture', 'Learning Intracorporeal Suture on Pelvitrainer', 'robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders', 'Robotized Versus Conventional Needle Holder']",['intracorporeal knot-tying task'],"[{'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0181952', 'cui_str': 'Needle holder, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]",20.0,0.0237045,"At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Siri', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Crochet', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France. Electronic address: pcrochet.marseille@gmail.com.'}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Charavil', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Netter', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Resseguier', 'Affiliation': 'Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Aubert', 'Initials': 'A', 'LastName': 'Agostini', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.016']
587,32135381,The Impact of Lactobacillus Probiotics on the Gut Microbiota in Children With Short Bowel Syndrome.,"BACKGROUND


Children with short bowel syndrome (SBS) frequently struggle with malabsorption and poor growth. The intestinal microbiota plays an important role in gut function, and children with SBS have known deficiencies in some commensal gut microbes. One strategy to enhance the gut microbiota is by taking probiotics. However, the efficacy of this approach is not well established. We hypothesized that probiotic supplementation would result in increased levels of the supplemented bacteria and improved growth.
MATERIALS AND METHODS


Children with SBS who had weaned from parenteral nutrition but with suboptimal growth were randomized to receive probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo daily for 2 mo. The gut microbiota from monthly stool samples were compared between groups using 16S ribosomal ribonucleic acid sequencing and quantitative polymerase chain reaction. Growth between groups was also compared. Statistical analysis was completed using Mann-Whitney, Kruskal-Wallis, and chi-square tests as appropriate.
RESULTS


Eighteen children with SBS completed the study (n = 9 per group). There were no significant changes to the major bacterial families in either group. Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P = 0.161). Median z scores for weight and length did not differ between groups at the beginning or end of the study.
CONCLUSIONS


The efficacy of daily probiotic use in children with intestinal failure is unknown. In this study, Lactobacillus probiotics did not result in a predictable change to the fecal microbiota or overall growth compared with placebo in these patients.",2020,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","['Children with SBS who had weaned from parenteral nutrition but with suboptimal growth', 'children with intestinal failure', 'Children with short bowel syndrome (SBS', 'Eighteen children with SBS completed the study (n\xa0=\xa09 per group', 'Children With Short Bowel Syndrome']","['placebo', 'probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo', 'Lactobacillus Probiotics', 'probiotic supplementation']","['fecal microbiota or overall growth', 'Median relative abundance of Lactobacillus', 'Gut Microbiota', 'levels of the supplemented bacteria and improved growth', 'Median z scores for weight and length']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0445728', 'cui_str': 'Lactobacillus johnsonii'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",18.0,0.0555,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","[{'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Piper', 'Affiliation': 'Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: hannah.piper@cw.bc.ca.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Coughlin', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Channabasappa', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Koh', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Microbiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.024']
588,32222255,Heart Rate Determination in Newborns at Risk for Resuscitation in a Low-Resource Setting: A Randomized Controlled Trial.,"OBJECTIVE


To compare 2 different methods (auscultation with a stethoscope and umbilical cord palpation) of heart rate (HR) estimation in newborns at risk for resuscitation in a low-resource setting.
STUDY DESIGN


Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia) were randomized to HR assessment by auscultation using a stethoscope or umbilical cord palpation. HR was assessed at 60, 90, 120 seconds, and 5 minutes of life. The primary outcome was the agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram.
RESULTS


Mean difference between auscultation using a stethoscope and electrocardiogram was -13 bpm, -4 bpm, -6 bpm, and -10 bpm at 60, 90, 120 seconds, and at 5 minutes of life. Mean difference between palpation and electrocardiogram of was -20 bpm, -25 bpm, -23 bpm, and -31 bpm at 60, 90, 120 seconds, and at 5 minutes of life. The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time (P = .007). HR range was correctly identified in 14 out of 16 measurements (87%) with HR <100 bpm.
CONCLUSION


HR assessment by auscultation was more accurate compared with cord palpation, but both may provide adequate clinical information to healthcare providers in terms of HR ranges. The clinical advantage of providing a stethoscope in low-resource settings remains to be established.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03854435.",2020,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"['Newborns at Risk for Resuscitation in a Low-Resource Setting', 'Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia', 'newborns at risk for resuscitation in a low-resource setting']","['methods (auscultation with a stethoscope and umbilical cord palpation', 'HR assessment by auscultation using a stethoscope or umbilical cord palpation']","['agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram', 'heart rate (HR) estimation', 'HR range']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0183559', 'cui_str': 'Stethoscopes'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.112529,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Independent statistician, Solagna, Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cori', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Senait', 'Initials': 'S', 'LastName': 'Negash', 'Affiliation': 'Department of Pediatrics, St. Luke Catholic Hospital, Wolisso, Ethiopia.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Azzimonti', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Wolisso, Ethiopia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Woman's and Child's Health, University of Padova, Padova, Italy. Electronic address: daniele.trevisanuto@unipd.it.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.026']
589,32218127,Nebulized Heparin in Burn Patients with Inhalation Trauma-Safety and Feasibility.,"BACKGROUND


Pulmonary hypercoagulopathy is intrinsic to inhalation trauma. Nebulized heparin could theoretically be beneficial in patients with inhalation injury, but current data are conflicting. We aimed to investigate the safety, feasibility, and effectiveness of nebulized heparin.
METHODS


International multicenter, double-blind, placebo-controlled randomized clinical trial in specialized burn care centers. Adult patients with inhalation trauma received nebulizations of unfractionated heparin (25,000 international unit (IU), 5 mL) or placebo (0.9% NaCl, 5 mL) every four hours for 14 days or until extubation. The primary outcome was the number of ventilator-free days at day 28 post-admission. Here, we report on the secondary outcomes related to safety and feasibility.
RESULTS


The study was prematurely stopped after inclusion of 13 patients (heparin  N  = 7, placebo  N  = 6) due to low recruitment and high costs associated with the trial medication. Therefore, no analyses on effectiveness were performed. In the heparin group, serious respiratory problems occurred due to saturation of the expiratory filter following nebulizations. In total, 129 out of 427 scheduled nebulizations were withheld in the heparin group (in 3 patients) and 45 out of 299 scheduled nebulizations were withheld in the placebo group (in 2 patients). Blood-stained sputum or expected increased bleeding risks were the most frequent reasons to withhold nebulizations.
CONCLUSION


In this prematurely stopped trial, we encountered important safety and feasibility issues related to frequent heparin nebulizations in burn patients with inhalation trauma. This should be taken into account when heparin nebulizations are considered in these patients.",2020,"Blood-stained sputum or expected increased bleeding risks were the most frequent reasons to withhold nebulizations.
","['In total, 129 out of 427 scheduled nebulizations', 'patients with inhalation injury', 'Adult patients with inhalation trauma', 'burn patients with inhalation trauma', 'specialized burn care centers', 'Burn Patients with Inhalation Trauma-Safety and Feasibility', '13 patients (heparin  N  = 7, placebo  N  = 6) due to low recruitment and high costs associated with the trial medication']","['Nebulized heparin', 'placebo', 'heparin', 'Nebulized Heparin', 'nebulizations of unfractionated heparin', 'nebulized heparin']","['safety and feasibility', 'number of ventilator-free days at day 28 post-admission', 'bleeding risks', 'serious respiratory problems']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745334', 'cui_str': 'Injury to respiratory system due to inhaled substance (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0585046', 'cui_str': 'Post admission (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.368088,"Blood-stained sputum or expected increased bleeding risks were the most frequent reasons to withhold nebulizations.
","[{'ForeName': 'Gerie J', 'Initials': 'GJ', 'LastName': 'Glas', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Binnekade', 'Affiliation': 'Department of Intensive Care, Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Muller', 'Affiliation': 'Department of Intensive Care, University Hospital Gasthuisberg, 3000 Leuven, Belgium.'}, {'ForeName': 'Berry', 'Initials': 'B', 'LastName': 'Cleffken', 'Affiliation': 'Department of Intensive Care, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Colpaert', 'Affiliation': 'Department of Intensive Care, Ghent University Hospital, 9000 Ghent, Belgium.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Dixon', 'Affiliation': ""Department of Intensive Care, St Vincent's Hospital, Melbourne 3065, Australia.""}, {'ForeName': 'Nicole P', 'Initials': 'NP', 'LastName': 'Juffermans', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knape', 'Affiliation': 'Department of Intensive Care, Red Cross Hospital, 1942 LE Beverwijk, The Netherlands.'}, {'ForeName': 'Marcel M', 'Initials': 'MM', 'LastName': 'Levi', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Bert G', 'Initials': 'BG', 'LastName': 'Loef', 'Affiliation': 'Department of Intensive Care, Martini Hospital, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Mackie', 'Affiliation': 'Department of Intensive Care, Red Cross Hospital, 1942 LE Beverwijk, The Netherlands.'}, {'ForeName': 'Manu L N G', 'Initials': 'MLNG', 'LastName': 'Malbrain', 'Affiliation': 'Department of Intensive Care and Faculty of Medicine and Pharmacy, University Hospital Brussels, Jette, Belgium and Free University of Brussels, 1090 Brussels, Belgium.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Auke C', 'Initials': 'AC', 'LastName': 'Reidinga', 'Affiliation': 'Department of Intensive Care, Martini Hospital, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'van der Sluijs', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, 1105 AZ Amsterdam, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9040894']
590,32220517,The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor.,"RESEARCH QUESTION


Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis.
DESIGN


Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420).
RESULTS


No statistically significant difference in live birth rate was found between the control group and the Embryogen®/BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used.
CONCLUSION


A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.",2020,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","['couples undergoing IVF/ICSI', '100 couples undergoing IVF/ICSI', 'women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis']","['Embryogen®/BlastGen', 'having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media', 'blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor']","['blastulation rate', 'grade of the embryo transferred', 'live birth rates', 'live birth rate']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",100.0,0.22946,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia. Electronic address: ryan.rose@adelaide.edu.au.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Barry', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Dunstan', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Siu Man', 'Initials': 'SM', 'LastName': 'Yuen', 'Affiliation': 'Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Lyndal P', 'Initials': 'LP', 'LastName': 'Cameron', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Knight', 'Affiliation': 'School of Public Health, Robinson Research Institute, AHMS Building, The University of Adelaide, North Terrace, Adelaide5005 SA, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'M Louise', 'Initials': 'ML', 'LastName': 'Hull', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.011']
591,30938760,Fructose Consumption Contributes to Hyperinsulinemia in Adolescents With Obesity Through a GLP-1-Mediated Mechanism.,"CONTEXT


The consumption of high-fructose beverages is associated with a higher risk for obesity and diabetes. Fructose can stimulate glucagon-like peptide 1 (GLP-1) secretion in lean adults, in the absence of any anorexic effect.
OBJECTIVE


We hypothesized that the ingestion of glucose and fructose may differentially stimulate GLP-1 and insulin response in lean adolescents and adolescents with obesity.
DESIGN


We studied 14 lean adolescents [four females; 15.9 ± 1.6 years of age; body mass index (BMI), 21.8 ± 2.2 kg/m2] and 23 adolescents with obesity (five females; 15.1 ± 1.6 years of age; BMI, 34.5 ± 4.6 kg/m2). Participants underwent a baseline oral glucose tolerance test to determine their glucose tolerance and estimate insulin sensitivity and β-cell function [oral disposition index (oDIcpep)]. Eligible subjects received, in a double-blind, crossover design, 75 g of glucose or fructose. Plasma was obtained every 10 minutes for 60 minutes for the measures of glucose, insulin, and GLP-1 (radioimmunoassay) and glucose-dependent insulinotropic polypeptide (GIP; ELISA). Incremental glucose and hormone levels were compared between lean individuals and those with obesity by a linear mixed model. The relationship between GLP-1 increment and oDIcpep was evaluated by regression analysis.
RESULTS


Following the fructose challenge, plasma glucose excursions were similar in both groups, yet the adolescents with obesity exhibited a greater insulin (P < 0.001) and GLP-1 (P < 0.001) increase than did their lean peers. Changes in GIP were similar in both groups. After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group. The GLP-1 increment during 60 minutes from fructose drink was correlated with a lower oDIcpep (r2 = 0.22, P = 0.009).
CONCLUSION


Fructose, but not glucose, ingestion elicits a higher GLP-1 and insulin response in adolescents with obesity than in lean adolescents. Fructose consumption may contribute to the hyperinsulinemic phenotype of adolescent obesity through a GLP-1-mediated mechanism.",2019,"After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group.","['Adolescents With Obesity Through a GLP-1-Mediated Mechanism', 'lean adolescents and adolescents with obesity', 'lean adults', '14 lean adolescents [four females; 15.9 ± 1.6 years of age; body mass index (BMI), 21.8 ± 2.2 kg/m2] and 23 adolescents with obesity (five females; 15.1 ± 1.6 years of age; BMI, 34.5 ± 4.6 kg/m2', 'Eligible subjects', 'adolescents with obesity than in lean adolescents']","['Fructose consumption', 'Fructose', 'glucose or fructose', 'Fructose Consumption']","['Changes in GIP', 'glucose tolerance and estimate insulin sensitivity and β-cell function [oral disposition index (oDIcpep', 'GLP-1 response', 'glucose, insulin, and GLP-1 (radioimmunoassay) and glucose-dependent insulinotropic polypeptide (GIP; ELISA', 'Incremental glucose and hormone levels', 'plasma glucose excursions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}]","[{'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",14.0,0.0386522,"After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group.","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Van Name', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00161']
592,31945300,Early Bactericidal Activity of Different Isoniazid Doses for Drug Resistant TB (INHindsight): A Randomized Open-label Clinical Trial.,"RATIONALE


High-dose isoniazid is recommended in short-course regimens for multidrug-resistant TB (MDR-TB). The optimal dose of isoniazid and its individual contribution to efficacy against TB strains with inhA or katG mutations are unknown.
OBJECTIVE


Define the optimal dose of isoniazid for patients with isoniazid-resistant TB mediated by inhA mutations.
METHODS


AIDS Clinical Trials Group A5312 is a Phase 2A, open-label trial in which individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation were randomized to receive isoniazid 5, 10 or 15 mg/kg daily for 7 days (inhA group), and controls with drug-sensitive TB received standard dose (5 mg/kg/day). Overnight sputum cultures were collected daily. The 7-day early bactericidal activity of isoniazid was estimated as the average daily change in log10 colony forming units on solid media (EBACFU0-7) or as time to positivity in liquid media in hours (EBATTP0-7) using nonlinear mixed effects models.
MEASUREMENTS AND MAIN RESULTS


Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa. Mean EBACFU0-7 at doses of 5, 10 and 15 mg/kg in the inhA group was 0.07, 0.17 and 0.22 log10CFU/mL/day, respectively, and 0.16 log10CFU/mL/day in controls. EBATTP0-7 patterns were similar. There were no drug-related Grade >3 adverse events.
CONCLUSIONS


Isoniazid 10-15 mg/kg daily had similar activity against TB strains with inhA mutations as 5 mg/kg against drug-sensitive strains. The activity of high-dose isoniazid against strains with katG mutations will be explored next. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01936831.",2020,"There were no drug-related Grade >3 adverse events.
","['Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa', 'individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation', 'Drug Resistant TB (INHindsight', 'patients with isoniazid-resistant TB mediated by inhA mutations']","['Isoniazid', 'isoniazid']",[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}]",[],59.0,0.319838,"There were no drug-related Grade >3 adverse events.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States; kdooley1@jhmi.edu.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'Stellenbosch University Faculty of Medicine and Health Sciences, 121470, TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'National Institutes of Health, Division of AIDS, Bethesda, Maryland, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Elisa H', 'Initials': 'EH', 'LastName': 'Ignatius', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Nuermberger', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems Inc, 43740, Silver Spring, Maryland, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, 2402, Boston, Massachusetts, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Nebraska Medicine, 21039, Omaha, Nebraska, United States.'}, {'ForeName': 'Naadira', 'Initials': 'N', 'LastName': 'Vanker', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'University of Stellenbosch, Internal Medicine, Tygerberg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1960OC']
593,31916011,Effect of an endoscopic bite block on one-handed mask ventilation.,"PURPOSE


An endoscopic bite block is a device to ensure that the patient's mouth remains wide open during endoscopic procedures. Wide opening of the mouth may facilitate the efficiency of one-handed mask ventilation. We evaluated the effect of an endoscopic bite block on mask ventilation among three ventilation techniques: one-handed ventilation, one-handed ventilation with an endoscopic bite block, and two-handed ventilation.
METHODS


Fifty-nine anesthetized and paralyzed patients were included. After induction of anesthesia, one-handed ventilation, one-handed ventilation with an endoscopic bite block and two-handed ventilation were performed in a cross-over, randomized order. The primary outcome was the expiratory tidal volume (mL/kg of predicted body weight). Secondary outcomes included minute ventilation (L/min) and the incidence of inadequate mask ventilation or dead space ventilation.
RESULTS


The expiratory tidal volume of one-handed ventilation with an endoscopic bite block was significantly improved when compared with that of one-handed ventilation (8.2 [6.8-10.2] mL/kg vs. 7.1 [4.5-9.0] mL/kg, respectively, difference = 1.1 mL/kg; 95% CI 0.8-2.4; P < 0.001), and was comparable to that of two-handed ventilation (8.9 [6.3-11.5] mL/kg; difference = 0.7 mL/kg; 95% CI - 0.7 to 1.5; P = 0.432). Minute ventilation was also significantly improved in one-handed ventilation with an endoscopic bite block compared with that in one-handed ventilation (7.4 [6.3-8.6] L/min vs. 6.7 [4.2-7.9] L/min, respectively, difference = 0.7 L/min; 95% CI 0.6-2.0; P < 0.001), and was comparable to that of two-handed ventilation (7.7 [6.5-9.5] L/min; difference = 0.3 L/min; 95% CI - 0.5 to 1.4; P = 0.390). The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
CONCLUSION


The use of an endoscopic bite block improved one-handed mask ventilation, showing comparable efficacy with two-handed mask ventilation.",2020,"The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
","['Fifty-nine', 'anesthetized and paralyzed patients']","['anesthesia, one-handed ventilation, one-handed ventilation with an endoscopic bite block and two-handed ventilation', 'endoscopic bite block']","['expiratory tidal volume of one-handed ventilation with an endoscopic bite block', 'incidence of inadequate ventilation or dead space ventilation', 'minute ventilation (L/min) and the incidence of inadequate mask ventilation or dead space ventilation', 'expiratory tidal volume (mL/kg of predicted body weight', 'Minute ventilation']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0179321', 'cui_str': 'Bite block (physical object)'}]","[{'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0179321', 'cui_str': 'Bite block (physical object)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",59.0,0.0825687,"The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
","[{'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jee-Eun', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dongwook', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jun', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Young', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea. mistyblue15@naver.com.'}]",Journal of anesthesia,['10.1007/s00540-019-02732-3']
594,31303143,Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.,"Background : People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal.  Objective : This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH.  Methods : HIV physicians and advanced practice providers ( n  = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent ( n  = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT ( n  = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT ( n  = 117).  Conclusions : TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.",2019,"After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists.","['People living with HIV (PLWH) frequently experience chronic pain and receive', 'Methods : HIV physicians and advanced practice providers ( n \u2009=\u200941) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta', 'people living with HIV', 'Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent ( n \u2009=\u2009187', 'clinics for HIV (TEACH', ' n \u2009=\u2009170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments']","['PLWH receiving LTOT', 'long-term opioid therapy (LTOT', ' ', 'control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists']","['Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.176385,"After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists.","[{'ForeName': 'Marlene C', 'Initials': 'MC', 'LastName': 'Lira', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'b Section of General Internal Medicine, Department of Medicine , University of Washington and Harborview Medical Center , Seatle , WA , USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'c Division of General Internal Medicine, Department of Medicine , University of Pittsburgh School of Medicine , Pittsburgh , PA , USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Colasanti', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Root', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'f Department of Biostatistics , Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Walley', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'g Department of Medicine , Boston University School of Medicine , Boston , MA , USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Shanahan', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Abrams', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Forman', 'Affiliation': 'h Biostatistics and Epidemiology Data Analytics Center , Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chaisson', 'Affiliation': 'h Biostatistics and Epidemiology Data Analytics Center , Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Podolsky', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}, {'ForeName': 'Kishna', 'Initials': 'K', 'LastName': 'Outlaw', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Harris', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Armstrong', 'Affiliation': 'e Division of Infectious Diseases, Department of Medicine , Emory University School of Medicine , Atlanta , GA , USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'd Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA.'}]",HIV research & clinical practice,['10.1080/15284336.2019.1627509']
595,30904228,"Impact of a 12-month Inflammation Management Intervention on the Dietary Inflammatory Index, inflammation, and lipids.","BACKGROUND AND AIMS


The objective of this study was to assess the feasibility (ability to recruit participants and develop the 12-month intervention), acceptability (retention of participants in the intervention), and impact on systemic inflammation and Dietary Inflammatory Index (DII®) scores over a 12-month DII-based intervention.
METHODS


Adults were recruited to participate in a self-selection trial (intervention: n = 61, in-person classes; control: n = 34, newsletters). Classes included participatory cooking and dietary recommendations focused on consuming a plant-based diet rich in anti-inflammatory foods (spices, vegetables, etc.). Changes in markers of inflammation, lipids, and DII were analyzed using general linear models with repeated measurements.
RESULTS


At 3 months, intervention participants had significantly lower DII scores (-2.66 ± 2.44) compared to controls (-0.38 ± 2.56) (p < 0.01); but not at 12 months (P = 0.10). The only biomarker to approach a significant group effect or group-by-time interaction was CRP (P = 0.11 for the group-by-time interaction). CRP decreased by -0.65 mg/L (95%CI = 0.10-1.20, P = 0.02) at 12 months in the intervention group; no significant decrease was seen for the control group. With both groups combined at 3 months, those with the greatest decrease/improvement in DII score (tertile 1) compared with those whose scores increased (tertile 3) had greater reductions in CRP (-1.09 vs. +0.52 mg/L, P = 0.04), total cholesterol (-9.38 vs. +12.02 mg/dL, P = 0.01), and LDL cholesterol (-11.99 vs. +7.16 mg/dL, P = 0.01).
CONCLUSIONS


Although the intervention group had reductions in DII and CRP, main inflammation and lipid outcomes did not differ between groups. Overall, those participants with the largest reduction in DII scores had the largest reductions in CRP and LDL and total cholesterol. Future interventions may need to have more components in place to support maintenance and continued reductions in the DII. CLINICALTRIALS.
GOV IDENTIFIER


NCT02382458.",2019,CRP decreased by -0.65 ,"['Adults were recruited to participate in a self-selection trial (intervention: n\xa0=\xa061, in-person classes; control: n\xa0=\xa034, newsletters']","['participatory cooking and dietary recommendations focused on consuming a plant-based diet rich', 'Inflammation Management Intervention']","['systemic inflammation and Dietary Inflammatory Index (DII®) scores', 'Dietary Inflammatory Index, inflammation, and lipids', 'lower DII scores', 'total cholesterol', 'DII score', 'CRP and LDL and total cholesterol', 'CRP', 'LDL cholesterol', 'DII and CRP, main inflammation and lipid outcomes', 'DII scores', 'markers of inflammation, lipids, and DII']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}]",,0.0579891,CRP decreased by -0.65 ,"[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Room 529, Columbia, SC 29208, USA. Electronic address: brie@sc.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, USA; Cancer Prevention and Control Program, Arnold School of Public Health, USA; College of Nursing, University of South Carolina, USA; Connecting Health Innovations LLC, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, USA; Cancer Prevention and Control Program, Arnold School of Public Health, USA; Connecting Health Innovations LLC, USA.'}, {'ForeName': 'Caroline G', 'Initials': 'CG', 'LastName': 'Dunn', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Room 529, Columbia, SC 29208, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Room 529, Columbia, SC 29208, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, USA.'}, {'ForeName': 'Delia S', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hussey', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, USA; Cancer Prevention and Control Program, Arnold School of Public Health, USA; Connecting Health Innovations LLC, USA.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.02.008']
596,31540617,Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.,"BACKGROUND


There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease.
METHODS


In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat.
RESULTS


Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU.
CONCLUSION


ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.",2019,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","['patients with HIV and liver disease', 'January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score\u202f>\u202f1.45']","['ISAT', 'Integrated stepped alcohol treatment', 'health handout plus routine care', 'integrated stepped alcohol treatment (ISAT', 'ISAT and TAU']","['liver biomarkers', 'Abstinence rates', 'proportion with an undetectable HIV viral load', 'alcohol use, HIV, and liver outcomes', 'VACS Index scores', 'FIB-4 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",95.0,0.155409,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY 13244, United States of America.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.007']
597,30903329,A novel volume-reduced CT colonography regimen using hypertonic laxative (polyethylene glycol with ascorbic acid): randomized controlled trial.,"OBJECTIVES


The aim of this study is to investigate the feasibility of bowel preparation using a hypertonic laxative (polyethylene glycol with ascorbic acid, PEG + Asc) for CT colonography (CTC) and to examine the volume limit of laxative.
METHODS


In one institution, patients who met the indications for CTC were enrolled and randomly assigned to CTC with regimen A (800 ml PEG + Asc), B (600 ml PEG + Asc), or C (400 ml PEG + Asc). Sodium diatrizoate was given orally for fecal tagging. On the previous day, patients ate low-residue meals and took the assigned lavage solution after dinner. A reader blinded to the preparation graded residual stool/fluid and fecal tagging quality in six segments of the colorectum. The primary outcome was a proportion of colon segments without stool. One hundred twenty segments in 20 patients with each regimen were needed to show a non-inferiority margin of 15%, assuming 85% of no stool.
RESULTS


A total of 360 segments in 60 patients were analyzed. There were 83% of segments with no stool in regimen A, 89% in regimen B, and 88% in regimen C. Using the delta method, the 95% confidence interval of the risk difference (6.7%) between regimens A and B was - 2.2% to 15.6%, and the risk difference (5.0%) between regimens A and C was - 4.1% to 14%, both within the non-inferiority margin. Residual fluid and fecal tagging quality were also within the non-inferiority margin. No adverse events occurred.
CONCLUSIONS


A novel CTC regimen using hypertonic laxative demonstrated optimal colon cleansing effectiveness even with the lowest volume of laxative (UMIN000022851).
KEY POINTS


• A novel CTC regimen using a hypertonic laxative is feasible. • The lowest volume of laxative provides excellent colon imaging. • However, the lowest volume of laxative did not improve patient acceptance.",2019,"No adverse events occurred.
","['A total of 360 segments in 60 patients were analyzed', 'One hundred twenty segments in 20 patients with each regimen', 'patients who met the indications for CTC']","['CT colonography (CTC', 'Sodium diatrizoate', 'CTC', 'hypertonic laxative (polyethylene glycol with ascorbic acid, PEG + Asc', 'hypertonic laxative', 'hypertonic laxative (polyethylene glycol with ascorbic acid']","['optimal colon cleansing effectiveness', 'adverse events', 'proportion of colon segments without stool', 'Residual fluid and fecal tagging quality', 'patient acceptance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C0935912', 'cui_str': 'CT Colonography'}, {'cui': 'C0012007', 'cui_str': 'diatrizoate sodium'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",20.0,0.0993827,"No adverse events occurred.
","[{'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Utano', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takayanagi', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Division of Screening Technology, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Aizawa', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Shungo', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Tetsutaro', 'Initials': 'T', 'LastName': 'Nemoto', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Nemoto', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Isohata', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Kazutomo', 'Initials': 'K', 'LastName': 'Togashi', 'Affiliation': 'Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan. togashik@fmu.ac.jp.'}]",European radiology,['10.1007/s00330-019-06127-6']
598,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
599,31083777,Nasal high-flow therapy compared with non-invasive ventilation in COPD patients with chronic respiratory failure: A randomized controlled cross-over trial.,"BACKGROUND AND OBJECTIVE


Non-invasive ventilation (NIV) is part of the standard of care for hypercapnic respiratory failure secondary to COPD, but may be poorly tolerated. Preliminary evidence suggests nasal high-flow (NHF) therapy may improve hypercapnia in COPD and be well tolerated. We compared NHF and NIV in people with COPD and chronic hypercapnic respiratory failure.
METHODS


Single-blind randomized controlled two-way cross-over single-centre trial was conducted in New Zealand. Twenty-four participants with stable hypercapnic COPD received: NHF at 45 L/min and NIV at 15/4 cm H 2  O, each for 60 min with a 15-min washout in between. The primary outcome was transcutaneous partial pressure of carbon dioxide (PtCO 2  ) at 60 min, adjusted for baseline.
RESULTS


NIV reduced the PtCO 2  more than NHF (mean (SD) at 60 min by -5.3 (5.0) vs -2.5 (3.5) mm Hg; difference: -2.8 (-5.0 to -0.5) P = 0.021). Difference across all time points was -2.5 mm Hg (95% CI -4.5 to -0.5, P = 0.016). There was no significant difference in the proportion of participants with a reduction of PtCO 2   ≥ 4 or ≥ 8 mm Hg. Participants rated NHF significantly better for ease of application, comfort and fit.
CONCLUSION


In stable COPD patients with chronic hypercapnia, NIV resulted in a greater reduction in PtCO 2  compared with NHF, which was of uncertain clinical significance. NHF was better tolerated than NIV and may be a therapeutic option for some people with hypercapnic respiratory failure.
CLINICAL TRIAL REGISTRATION


ACTRN12616001701415 at www.anzctr.org.au.",2019,NIV reduced the PtCO 2  more than NHF (mean (SD) at 60 min by -5.3 (5.0) vs -2.5,"['COPD patients with chronic respiratory failure', 'people with COPD and chronic hypercapnic respiratory failure', 'Twenty-four participants with stable hypercapnic COPD received']","['NHF and NIV', 'Nasal high-flow therapy compared with non-invasive ventilation', 'NHF']","['transcutaneous partial pressure of carbon dioxide (PtCO 2  ) at 60\u2009min, adjusted for baseline']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure (disorder)'}, {'cui': 'C1960052', 'cui_str': 'Chronic type II respiratory failure'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0040653', 'cui_str': 'Transcutaneous Capnometry'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",24.0,0.480436,NIV reduced the PtCO 2  more than NHF (mean (SD) at 60 min by -5.3 (5.0) vs -2.5,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McKinstry', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jan Pieter', 'Initials': 'JP', 'LastName': 'Baarsma', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13575']
600,32229139,The short-term effect of dark chocolate flavanols on cognition in older adults: A randomized controlled trial (FlaSeCo).,"BACKGROUND


Cocoa flavanols in the diet have had positive effects on cognition, blood lipid levels, and glucose metabolism.
METHODS


Cognitively healthy older adults aged 65-75 years were recruited for an eight-week randomized, double-blind controlled trial to investigate the effectiveness of cocoa flavanols on cognitive functions. At baseline, nutrient and polyphenol intakes from diet were assessed with three-day food diaries. The intervention group received 50 g dark chocolate containing 410 mg of flavanols per day, and the control group 50 g dark chocolate containing 86 mg of flavanols per day, for eight weeks. Cognition was assessed with Verbal Fluency (VF) and the Trail Making Test (TMT) A and B as the main outcome measures. Changes in blood lipids and glucose were also measured.
RESULTS


The older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74). They were highly educated with a mean 14.9 years of education (SD 3.6). No differences in changes in cognition were seen between groups. The mean change (± SEs) in the time to complete the TMT A and B in the intervention group was -4.6 s (-7.1 to -2.1) and -16.1 s (-29.1 to -3.1), and in the controls -4.4 s (-7.0 to -1.9) and -12.5 s (-22.8 to -2.1)(TMT A p = 0.93; TMT B p = 0.66). No difference was apparent in the changes in blood lipids, glucose levels, or body weight between the groups.
CONCLUSIONS


The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.",2020,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"['older adults', 'healthy older adults', 'older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74', 'Cognitively healthy older adults aged 65-75\u202fyears', 'They were highly educated with a mean 14.9\u202fyears of education (SD 3.6']","['cocoa flavanols', '50\u202fg dark chocolate containing 410\u202fmg of flavanols per day, and the control group 50\u202fg dark chocolate containing 86\u202fmg of flavanols', 'dark chocolate flavanols', '2.1)(TMT']","['mean change (± SEs', 'blood lipids and glucose', 'Verbal Fluency (VF) and the Trail Making Test (TMT', 'cognitive functions', 'changes in cognition', 'cognition, blood lipid levels, and glucose metabolism', 'blood lipids, glucose levels, or body weight']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857756', 'cui_str': 'Highly educated'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0700198,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland. Electronic address: merja.suominen@gery.fi.'}, {'ForeName': 'M M L', 'Initials': 'MML', 'LastName': 'Laaksonen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Salmenius-Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Hongisto', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tuukkanen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}]",Experimental gerontology,['10.1016/j.exger.2020.110933']
601,31950267,Differential effects of sevoflurane and propofol on an electroretinogram and visual evoked potentials.,"The purpose of this study was to simultaneously evaluate the effects of sevoflurane and propofol on an electroretinogram (ERG) and visual evoked potentials (VEPs). Twenty-four patients scheduled for elective surgery under general anesthesia were allocated randomly to receive either sevoflurane (group S) or propofol (group P). An ERG and VEPs were recorded in an awake state and during anesthesia with three different minimum alveolar concentrations (MAC; 0.5, 1.0, and 1.5) of sevoflurane in group S or with three different effect-site concentrations (Ce) of 2, 3, and 4 μg/ml by using a target-controlled infusion technique in group P. Sevoflurane and propofol had little effect on amplitudes of the ERG b-wave. Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC. Propofol did not significantly decrease the amplitude of VEPs at Ce of 2 or 3 μg/ml but significantly decreased it at Ce of 4 μg/ml. In summary, propofol and sevoflurane at clinical concentrations had little effect on the amplitude of an ERG. Sevoflurane attenuated the amplitudes of VEPs even at low concentrations. Propofol also attenuated the amplitudes of VEPs to a lesser extent compared to sevoflurane.",2020,"Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC.",['Twenty-four patients scheduled for elective surgery under general anesthesia'],"['sevoflurane and propofol', 'Sevoflurane and propofol', 'Sevoflurane', 'propofol and sevoflurane', 'propofol', 'sevoflurane', 'Propofol']","['amplitude of an ERG', 'amplitudes of VEPs', 'amplitudes of VEP N75-P100', 'electroretinogram (ERG) and visual evoked potentials (VEPs', 'amplitude of VEPs', 'electroretinogram and visual evoked potentials']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}]",24.0,0.0404969,"Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC.","[{'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan. s_tanaka@shinshu-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ichino', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fuseya', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Mikito', 'Initials': 'M', 'LastName': 'Kawamata', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02733-7']
602,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
603,30880163,"Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial.","BACKGROUND


Untreated opioid addiction in people with HIV is associated with poor HIV treatment outcomes. Slow-release, long-acting, implantable naltrexone might improve these outcomes. Here, we present results of a study aimed to test this hypothesis.
METHODS


We did a 48 week double-blind, double-dummy, placebo-controlled, phase 3, randomised trial with men and women addicted to opioids who were starting antiretroviral therapy (ART) for HIV and whose viral loads were higher than 1000 copies per mL. Participants were seeking treatment at two HIV and two narcology programme centres in Saint Petersburg, Russia, and the surrounding Leningrad region. The Pavlov statistical department created a table with stratification on gender distribution, viral load, and CD4 cell count. We stratified participants according to gender, viral load, and CD4 cells per μL, and randomly assigned (1:1) them to addiction treatment with a naltrexone implant and oral naltrexone placebo (implant group) or oral naltrexone and placebo implant (oral group). The primary outcome was plasma viral load of less than 400 copies per mL at 24 weeks and 48 weeks. We included all randomly assigned participants in outcome analyses (intention to treat). Treatment staff and patients were masked to group assignment. The study is complete and registered at ClinicalTrials.gov, NCT01101815.
FINDINGS


Between July 14, 2011, and April 14, 2014, 238 potential participants were recruited and screened, 35 were excluded for not meeting inclusion criteria, three declined to participate, and 200 were randomly assigned to treatment (100 to each group). At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77). At week 48, 66 participants in the implant group and 50 in the oral group had viral loads less than 400 copies per mL (risk ratio 1·32, 95% CI 1·04-1·68; p=0·045). There were seven serious adverse events: three deaths in the implant group (one due to heart disease, one trauma, and one AIDS), and four in the oral group (two overdoses, one pancreatic cancer, and one AIDS). The overdose deaths occurred 9-10 months after the last naltrexone dose.
INTERPRETATION


The longer the blockade of opioid effects, the more protection an individual gets from missed ART doses and impulsive behaviours that lead to relapse and poor, even fatal, outcomes. Commercial development of implants could result in a meaningful addition to addiction treatment options.
FUNDING


National Institutes of Health, National Institute on Drug Abuse, Penn Centre for AIDS Research, and Penn Mental Health AIDS Research Centre.",2019,"At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77).","['people with HIV', 'men and women addicted to opioids who were starting antiretroviral therapy (ART) for HIV and whose viral loads were higher than 1000 copies per mL. Participants were seeking treatment at two HIV and two narcology programme centres in Saint Petersburg, Russia, and the surrounding Leningrad region', 'stratified participants according to gender, viral load, and CD4 cells per μL, and randomly assigned (1:1) them to addiction treatment with a', 'Between July 14, 2011, and April 14, 2014, 238 potential participants were recruited and screened, 35 were excluded for not meeting inclusion criteria, three declined to participate, and 200', 'people with HIV who are addicted to opioids']","['Slow-release naltrexone implant versus oral naltrexone', 'naltrexone implant and oral naltrexone placebo (implant group) or oral naltrexone and placebo implant (oral group', 'placebo']","['plasma viral load', 'overdose deaths', 'viral loads less', 'viral loads']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1.0,0.648254,"At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77).","[{'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; VM Bekhterev National Medical Research Centre for Psychiatry and Neurology, Saint Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Zvartau', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verbitskaya', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Palatkin', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Vetrova', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bushara', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Burakov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Masalov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mamontova', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Langleben', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Poole', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Woody', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: woodyg@pennmedicine.upenn.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(18)30362-X']
604,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
605,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
606,32219705,Does quality of life feedback promote seeking help for undiagnosed cancer?,"PURPOSE


Diagnosing cancer early is an imperative, as help-seeking delays affect survival. Quality of life (QoL) deteriorates after diagnosis, but decline may start when cancer is suspected at the earliest stage of the pathway to treatment. This study examined whether offering guided feedback about personal QoL to adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care.
METHODS


Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites. A prospective longitudinal (2 × 2) repeated-measures design was applied. Where they presented a potential cancer symptom, and were 'signposted' to a GP, they were allocated to a symptom condition, or a lifestyle condition, if seeking cancer risk advice. Randomisation was to an Intervention group, who received feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback. Depression was screened.
RESULTS


Of 107 participants, the mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill. Over 10 weeks, 54% of all those with symptoms sought help from a medical source and 42% specifically from a GP. Thirty-one completed all three assessments. With symptoms present, psychological, social and environmental QoL were poor, becoming poorer over time. When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected. However, feedback increased help-seeking from informal social contacts. Lifestyle groups reported consistently good psychological and social QoL.
CONCLUSION


This early cancer research offers practical and theoretical implications for QoL interventions in deprived communities.",2020,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","['Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites', 'adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care', '107 participants', 'mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill']","['guided feedback about personal QoL', 'feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback']","['good psychological and social QoL', 'Quality of life (QoL) deteriorates', 'feedback, psychological QoL increased, but GP visits', 'psychological, social and environmental QoL']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",107.0,0.0221673,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","[{'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Skevington', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK. suzanne.skevington@manchester.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gartland', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02431-7']
607,32090783,Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.,"BACKGROUND


The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates.
METHODS


Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth.
RESULTS


Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes.
LIMITATIONS


The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data.
CONCLUSIONS


This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.",2020,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","['perinatal depression delivered through peers', 'Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to', '850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up']","['THPP plus enhanced usual care (EUC) or EUC-only', 'THPP', 'Thinking Healthy Programme (THP', 'India and Pakistan', 'THP', 'Thinking Healthy Programme']","['lower symptom severity (PHQ-9 score', 'symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth', 'depression, disability and social support at 3 and 6 months post-childbirth']","[{'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0060462', 'cui_str': 'flopropione'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0217641', 'cui_str': '4-Pyrimidinecarboxylic acid, 1,4,5,6-tetrahydro-2-methyl-'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0037438'}]",850.0,0.199711,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: fiona.vanobberghen@swisstph.ch.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Faculty of Public Health and Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan; Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Ejma', 'Initials': 'E', 'LastName': 'Afonso', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ikhlaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Bilal', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Aveena', 'Initials': 'A', 'LastName': 'De Sa', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': ""D'Souza"", 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Korgaonkar', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Lazarus', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Rakshanda', 'Initials': 'R', 'LastName': 'Liaqat', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sharif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Faculty of Epidemiology and Population Health, Department of Population Health, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Shaffaq', 'Initials': 'S', 'LastName': 'Zuliqar', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.110']
608,32216964,Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial.,"BACKGROUND


Excessive intraoperative hemorrhage is a critical factor of poor prognoses after hepatectomy. Low central venous pressure during parenchymal transection is recognized to effectively reduce intraoperative hemorrhage in open procedures. However, the role of controlled low central venous pressure in laparoscopic hepatectomy is still controversial.
METHODS


In the present randomized clinical trial, we set up a standard boundary of low central venous pressure according to our Pilot Study, then enrolled patients scheduled for elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group. The primary efficacy endpoint was total intraoperative blood loss and perioperative adverse events. Analyses were performed following the intention-to-treat principle, and patients and surgeons were blinded (ClinicalTrials.gov, Number: NCT03422913).
RESULTS


Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses. Based on the retrospective training cohort, we set a central venous pressure of 5 cm H 2 O as a cutoff value (standard low central venous pressure). Compared with patients in the control group, those in the controlled low central venous pressure group had a significantly lower central venous pressure during resection (4.83 ± 3.41 cm H 2 O vs 9.26 ± 3.38 cm H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001). The perioperative adverse events were comparable in both study groups (P = .313).
CONCLUSION


The safety and efficacy of controlled low central venous pressure were demonstrated in complex laparoscopic hepatectomy for the first time by our study, and this technique is recommended to be applied routinely in laparoscopic hepatectomy.",2020,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"['Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses']","['laparoscopic hepatectomy', 'elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group', 'control low central venous pressure']","['total intraoperative blood loss and perioperative adverse events', 'perioperative adverse events', 'intraoperative hemorrhage', 'central venous pressure', 'blood loss', 'total intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}]",469.0,0.0917269,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"[{'ForeName': 'Yang-Xun', 'Initials': 'YX', 'LastName': 'Pan', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jun-Cheng', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jin-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jian-Cong', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yi-Zhen', 'Initials': 'YZ', 'LastName': 'Fu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Min-Shan', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Ren-Chun', 'Initials': 'RC', 'LastName': 'Lai', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: lairch@sysucc.org.cn.'}, {'ForeName': 'Zhong-Guo', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: zhouzhg@sysucc.org.cn.'}]",Surgery,['10.1016/j.surg.2020.02.004']
609,32211798,Circulating Insulin-Like Growth Factor-1 Is Positively Associated with Growth and Cognition in 6- to 9-Year-Old Schoolchildren from Ghana.,"BACKGROUND


Milk intake stimulates linear growth and improves cognition in children from low-income countries. These effects may be mediated through insulin-like growth factor-1 (IGF-1).
OBJECTIVE


The objective was to assess the effect of milk supplement on circulating IGF-1 and to assess IGF-1 as a correlate of growth and cognition in children.
METHODS


Secondary data on blood spot IGF-1 from a randomized, double-blind, controlled trial in 6-9-y-old children from rural Ghana were analyzed. Intervention groups received porridge with non-energy-balanced supplements: 8.8 g milk protein/d, 100 kcal/d (Milk8); 4.4 g milk and 4.4 g rice protein/d, 100 kcal/d (Milk/rice); 4.4 g milk protein/d, 48 kcal/d (Milk4); or a control (no protein, 10 kcal/d). IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB) were measured at 3.5 or 8.5 mo. Linear regressions were used to assess the effect of milk interventions on IGF-1 and IGF-1 as a correlate of growth and cognition.
RESULTS


The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3) ng/mL higher in children receiving Milk8 compared with the control. The IGF-1 increases in the isonitrogenous, isoenergetic Milk/rice or the Milk4 groups were not different from the control (P ≥ 0.49). The increase in IGF-1 was associated with improvements in 4 out of 5 CANTAB domains. The strongest associations included reductions in ""mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra/Extradimensional Set Shift (P ≤ 0.005). In addition, change in IGF-1 was positively associated with changes in height, weight, and fat-free mass (P ≤ 0.001).
CONCLUSIONS


Intake of skimmed milk powder corresponding to one, but not half a glass of milk on school days stimulates IGF-1 in 6-9-y-old Ghanian children. IGF-1 seems to mediate the effect of milk intake on growth and cognition. The association between IGF-1 and cognition in relation to milk intake is novel and opens possibilities for dietary interventions to improve cognition.",2020,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","['6-9-y-old children from rural Ghana were analyzed', 'children', 'children from low-income countries']","['porridge with non-energy-balanced supplements: 8.8\xa0g milk protein', 'milk supplement']","['change in IGF-1', 'IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB', 'IGF-1', 'IGF-1 increases', 'Circulating Insulin-Like Growth Factor-1', 'mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra', 'Growth and Cognition', 'blood spot IGF-1', 'height, weight, and fat-free mass']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",,0.0402681,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Serena', 'Affiliation': 'Global Nutrition, Arla Foods amba, Skejby, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa075']
610,32186246,Multicap to improve adherence after acute coronary syndromes: results of a randomized controlled clinical trial.,"BACKGROUND


Adherence to treatment after a myocardial infarction (MI) is poor, even in the early postinfarction period. Combining evidence-based drugs into a multicap could improve adherence in this population. No previous randomized trial assessing fixed-dose combination therapy has included patients early after a MI. We aimed to assess if a multicap containing four secondary prevention drugs increases adherence to treatment at 6 months after MI hospitalization. The study was designed as a randomized, parallel, open-label, controlled trial.
METHODS


Patients were randomized within 7 days of a MI to either multicap or control group. The multicap group received a capsule containing aspirin, atenolol, ramipril, and simvastatin. The control group received each drug in separate pills. The primary outcome was adherence at 6 months. We also measured blood pressure, heart rate, serum cholesterol levels, C-reactive protein, and platelet aggregation.
RESULTS


The study was stopped prematurely when 100 patients were included for futility. At 6 months, 92 (95.8%) patients were adherent to medical treatment: 98.0% in the multicap group and 93.5% in the control group [relative risk (RR) 1.05; 95% confidence interval (CI) 0.96-1.14;  p  = 0.347]. There were no differences between groups in systolic blood pressure ( p  = 0.662), diastolic blood pressure ( p  = 0.784), heart rate ( p  = 0.533), total cholesterol ( p  = 0.760), LDL-c ( p  = 0.979), C-reactive protein ( p  = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition ( p  = 0.600).
CONCLUSIONS


The study did not find any improvement in the adherence at 6 months after a MI with a multicap-based strategy (Multicap for Increase Adherence After Acute Myocardial Infarction; [ ClinicalTrials.gov identifier: NCT02271178]).",2020,"There were no differences between groups in systolic blood pressure ( p  = 0.662), diastolic blood pressure ( p  = 0.784), heart rate ( p  = 0.533), total cholesterol ( p  = 0.760), LDL-c ( p  = 0.979), C-reactive protein ( p  = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition ( p  = 0.600).
","['Patients', 'acute coronary syndromes', '100 patients were included for futility']","['MI to either multicap or control group', 'multicap containing four secondary prevention drugs', 'Multicap', 'capsule containing aspirin, atenolol, ramipril, and simvastatin']","['systolic blood pressure', 'blood pressure, heart rate, serum cholesterol levels, C-reactive protein, and platelet aggregation', 'total cholesterol', 'adherence at 6\u2009months', 'Adherence', 'heart rate', 'C-reactive protein', 'diastolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086322', 'cui_str': 'Futility'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1626413', 'cui_str': 'Contains aspirin'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1287371', 'cui_str': 'Finding of serum cholesterol level (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",100.0,0.191336,"There were no differences between groups in systolic blood pressure ( p  = 0.662), diastolic blood pressure ( p  = 0.784), heart rate ( p  = 0.533), total cholesterol ( p  = 0.760), LDL-c ( p  = 0.979), C-reactive protein ( p  = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition ( p  = 0.600).
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mariani', 'Affiliation': 'Cardiology Department, Hospital El Cruce, Avenida Calchaquí 5401, Florencio Varela, Buenos Aires, CP 1888, Argentina.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Rosende', 'Affiliation': 'Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'De Abreu', 'Affiliation': 'Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gonzalez Villa Monte', 'Affiliation': 'Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Heraldo', 'Initials': 'H', 'LastName': ""D'Imperio"", 'Affiliation': 'Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Antonietti', 'Affiliation': 'Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Lemonnier', 'Affiliation': 'Pharmacy Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'de Bonis', 'Affiliation': 'Hemotherapy Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tajer', 'Affiliation': 'Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.'}]",Therapeutic advances in cardiovascular disease,['10.1177/1753944720912071']
611,30826660,Prognostic association of PTGS2 (COX-2) over-expression according to BRAF mutation status in colorectal cancer: Results from two prospective cohorts and CALGB 89803 (Alliance) trial.,"BACKGROUND


Prostaglandin-endoperoxide synthase 2 (PTGS2, cyclooxygenase-2, COX-2)-prostaglandin E 2  (PGE 2 ) pathway promotes tumour progression. Considering evidence suggesting increased PGE 2  synthesis by BRAF mutation in tumour cells, we hypothesised that the association of tumour PTGS2 (COX-2) expression with colorectal cancer mortality might be stronger in BRAF-mutated tumours than in BRAF-wild-type tumours.
METHODS


Using 1708 patients, including 1200 stage I-IV colorectal carcinoma cases in the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS) and 508 stage III colon cancer cases in a National Cancer Institute-sponsored randomised controlled trial of adjuvant therapy (CALGB/Alliance 89803), we evaluated tumour PTGS2 (COX-2) expression status using immunohistochemistry. We examined the prognostic association of PTGS2 (COX-2) expression in strata of BRAF mutation status by multivariable Cox proportional hazards regression models to adjust for potential confounders, including disease stage, tumour differentiation, microsatellite instability status and KRAS and PIK3CA mutations.
RESULTS


In NHS and HPFS, the association of PTGS2 (COX-2) expression with colorectal cancer-specific survival differed by BRAF mutation status (P interaction  = 0.0005); compared with PTGS2 (COX-2)-negative/low carcinomas, the multivariable-adjusted hazard ratios for PTGS2 (COX-2)-high carcinomas were 2.44 (95% confidence interval, 1.39-4.28) in BRAF-mutated cases and 0.82 (95% confidence interval, 0.65-1.04) in BRAF-wild-type cases. Differential prognostic associations of PTGS2 (COX-2) expression in strata of BRAF mutation status were similarly observed in CALGB/Alliance 89803 trial (P interaction  = 0.03).
CONCLUSIONS


The association of tumour PTGS2 (COX-2) expression with colorectal cancer mortality is stronger in BRAF-mutated tumours than in BRAF-wild-type tumours, supporting interactive roles of PTGS2 (COX-2) expression and BRAF mutation statuses in prognostication of patients with colorectal cancer; ClinicalTrials.gov Identifier, NCT00003835.",2019,"The association of tumour PTGS2 (COX-2) expression with colorectal cancer mortality is stronger in BRAF-mutated tumours than in BRAF-wild-type tumours, supporting interactive roles of PTGS2 (COX-2) expression and BRAF mutation statuses in prognostication of patients with colorectal cancer; ClinicalTrials.gov Identifier, NCT00003835.","['patients with colorectal cancer', 'colorectal cancer', ""1708 patients, including 1200 stage I-IV colorectal carcinoma cases in the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS) and 508 stage III colon cancer cases in a National Cancer Institute-sponsored randomised controlled trial of adjuvant therapy (CALGB/Alliance 89803""]","['Prostaglandin-endoperoxide synthase 2 (PTGS2, cyclooxygenase-2, COX-2)-prostaglandin E 2  (PGE 2 ', 'PTGS2 (COX-2']","['BRAF mutation status', 'PTGS2 (COX-2) expression with colorectal cancer-specific survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}]","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0942052,"The association of tumour PTGS2 (COX-2) expression with colorectal cancer mortality is stronger in BRAF-mutated tumours than in BRAF-wild-type tumours, supporting interactive roles of PTGS2 (COX-2) expression and BRAF mutation statuses in prognostication of patients with colorectal cancer; ClinicalTrials.gov Identifier, NCT00003835.","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kosumi', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Epidemiology and Biostatistics, and the Ministry of Education Key Lab of Environment and Health, School of Public Health, Huazhong University of Science and Technology, Wuhan, PR China.'}, {'ForeName': 'Annacarolina', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Koh', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Department of Hematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Twombly', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mima', 'Affiliation': 'Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Morikawa', 'Affiliation': 'Department of Pathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Nowak', 'Affiliation': ""Program in MPE Molecular Pathological Epidemiology, Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Nishihara', 'Affiliation': ""Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Program in MPE Molecular Pathological Epidemiology, Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Alliance Statistics and Data Center and Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Giannakis', 'Affiliation': ""Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Broad Institute of MIT and Harvard, Cambridge, MA, USA; Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA; Broad Institute of MIT and Harvard, Cambridge, MA, USA; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA; Department of Medicine, Yale School of Medicine, New Haven, CT, USA; Smilow Cancer Hospital, New Haven, CT, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ogino', 'Affiliation': ""Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Program in MPE Molecular Pathological Epidemiology, Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Broad Institute of MIT and Harvard, Cambridge, MA, USA. Electronic address: shuji_ogino@dfci.harvard.edu.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.01.022']
612,32092608,Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being.,"BACKGROUND


Musculoskeletal fatigue and pain as a consequence of performing surgery is found in 70%-87% of surgeons. The aim of this study was to examine the effect of microbreaks on surgeons' performance and well-being during laparoscopic appendectomy.
MATERIALS AND METHODS


The study was a blinded randomized crossover trial. Twelve surgeons were tested at three time points: Before surgery (baseline), after surgery without intervention, and after surgery where microbreaks were used every 10 min for 10 s. The musculoskeletal endurance test was used as the primary outcome. Performance was assessed by procedure length and a manual precision test. The surgeons' well-being was measured by level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs.
RESULTS


No significant differences were found in musculoskeletal endurance, procedure time, or the manual precision test. The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03). However, no significant difference was found between the two (P = 0.25). There was a significant increase from baseline regarding self-reported musculoskeletal discomfort in the back, shoulders, and legs after surgery but no significant differences between procedures with and without microbreaks.
CONCLUSIONS


This study did not find a positive effect of microbreaks on laparoscopic appendectomy. Exhaustion and discomfort were present after surgery, demonstrating that short surgical procedures (less than 60 min) can result in fatigue in surgeons.",2020,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,[],['laparoscopic appendectomy'],"['musculoskeletal discomfort', 'level of exhaustion', 'musculoskeletal endurance, procedure time, or the manual precision test', 'Exhaustion and discomfort', 'level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs']",[],"[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",12.0,0.198755,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,"[{'ForeName': 'Laurits Schou', 'Initials': 'LS', 'LastName': 'Kromberg', 'Affiliation': 'Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark. Electronic address: laurits.s.hansen@gmail.com.'}, {'ForeName': 'Niels Vinkel', 'Initials': 'NV', 'LastName': 'Kildebro', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Laura Quitzau', 'Initials': 'LQ', 'LastName': 'Mortensen', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Amirian', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.007']
613,31855161,"Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial.","STUDY OBJECTIVES


We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD).
METHODS


This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior.
RESULTS


The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: -5.51 ± 1.03 for the active intervention, -1.50 ± 1.24 for the control intervention).
CONCLUSIONS


A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152, identifier: NCT01816152.",2019,"The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention).","['Older Adults With Alzheimer Disease and Related Dementias', '46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout', 'persons with Alzheimer disease and related dementias (ADRD', 'patients with dementia living in controlled environments', 'Persons With Dementia, URL']","['lighting intervention', 'control lighting intervention', 'Tailored Lighting Intervention', 'placebo']","['sleep, mood, and behavior', 'Pittsburgh Sleep Quality Index scores', 'Sleep Quality, Rest-Activity, Mood, and Behavior', 'Cornell Scale for Depression in Dementia scores', 'Cohen-Mansfield Agitation Inventory scores', 'sleep quality, mood, and behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0014409', 'cui_str': 'Environment, Controlled'}, {'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023700', 'cui_str': 'Illumination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.252138,"The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention).","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Plitnick', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Roohan', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kalsher', 'Affiliation': 'Cognitive Science Department, School of Humanities, Arts and Social Sciences, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Rea', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8078']
614,32221696,Differences in acute reinforcement across reduced nicotine content cigarettes.,"RATIONALE


The smallest difference in nicotine that can change a smoker's cigarette preference is not clearly known.
OBJECTIVE


A procedure to efficiently identify the difference in nicotine needed to change cigarette preference could help inform research to gauge effects of a nicotine reduction policy.
METHODS


Using a within-subject design, we assessed preference for research cigarettes varying in nicotine contents (NIC; 18.7, 10.8, 5.3, 2.3, and 1.3 mg/g of tobacco), relative to a very low nicotine cigarette (VLNC; 0.4 mg/g), in 17 adult-dependent non-menthol smokers abstinent overnight. Only one NIC was compared vs. the VLNC per session, with order of the five NIC contents randomized across sessions on five separate days. Preference for each NIC vs. VLNC was determined by validated forced choice procedure, with those NIC chosen more than VLNC indicating greater reinforcement due to greater nicotine per se. Secondarily, less preference for lower NIC (vs. VLNC), relative to choice for the highest NIC, 18.7 mg/g (vs. VLNC), indexed reduced reinforcement.
RESULTS


Overall, NIC choices increased as their nicotine increased, as anticipated. Relative to the 0.4 mg/g VLNC, choice was greater for NIC ≥ 5.3 mg/g but not ≤ 2.3 mg/g. Correspondingly, relative to choice for 18.7 mg/g, choice was less for NIC ≤ 2.3 mg/g but not ≥ 5.3 mg/g.
CONCLUSIONS


Although replication with larger samples and longer access is needed, results indicate that nicotine reduction to ≤ 2.3 mg/g in cigarettes would attenuate reinforcement. This choice procedure may efficiently inform future clinical trials to assess relative reinforcing effects of smoking reduced nicotine cigarettes.",2020,"VLNC, choice was greater for NIC ≥ ",['17 adult-dependent non-menthol smokers abstinent overnight'],"['nicotine', 'mg/g of tobacco', 'low nicotine cigarette (VLNC']","['Overall, NIC choices']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",17.0,0.0328602,"VLNC, choice was greater for NIC ≥ ","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': ""Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA. perkinska@upmc.edu.""}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': ""Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.""}]",Psychopharmacology,['10.1007/s00213-020-05509-9']
615,32216011,Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction.,"AIMS


The effects of vericiguat vs. placebo on high-sensitivity C-reactive protein (hsCRP) and serum uric acid (SUA) were assessed in patients with heart failure with reduced ejection fraction (HFrEF) in the Phase 2 SOCRATES-REDUCED study (NCT01951625).
METHODS AND RESULTS


Changes from baseline hsCRP and SUA values at 12 weeks with placebo and vericiguat (1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg, respectively) were assessed. The probability of achieving an hsCRP value of ≤3.0 mg/L or SUA value of <7.0 mg/dL at week 12 was tested. Median baseline hsCRP and SUA levels were 3.68 mg/L [interquartile range (IQR) 1.41-8.41; n = 335] and 7.80 mg/dL (IQR 6.40-9.33; n = 348), respectively. Baseline-adjusted mean percentage changes in hsCRP were 0.2%, -19.5%, -24.3%, -25.7% and -31.9% in the placebo and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the vericiguat 10.0 mg group (P = 0.035). Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively). Estimated probability for an end-of-treatment hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL was higher with vericiguat compared with placebo. The effect was dose-dependent, with the greatest effect observed in the 10.0 mg group.
CONCLUSIONS


Vericiguat treatment for 12 weeks was associated with reductions in hsCRP and SUA, and a higher likelihood of achieving an hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL.",2020,"Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively).","['vericiguat-treated patients with heart failure with reduced ejection fraction', 'patients with heart failure with reduced ejection fraction (HFrEF) in the Phase\u20092']","['vericiguat vs. placebo', 'placebo', 'high-sensitivity C-reactive protein and uric acid', 'placebo and vericiguat']","['SUA', 'high-sensitivity C-reactive protein (hsCRP) and serum uric acid (SUA', 'hsCRP', 'Median baseline hsCRP and SUA levels']","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",348.0,0.118843,"Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kramer', 'Affiliation': 'Medical Devices and eHealth Clinical, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Voss', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Clinical Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Bernd-Wolfgang', 'Initials': 'BW', 'LastName': 'Igl', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre and Duke University-National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Italian Association of Hospital Cardiologists (ANMCO) Research Centre, Florence, Italy.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1787']
616,30343620,Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected  BRAF  V600-Mutant Stage III Melanoma.,"PURPOSE


Dabrafenib plus trametinib improved relapse-free survival (RFS) versus placebo (hazard ratio [HR], 0.47;  P  < .001) in patients with resected  BRAF  V600-mutant stage III melanoma (BRF115532; COMBI-AD; ClinicalTrials.gov identifier: NCT01682083). We present an updated RFS analysis on the basis of extended study follow-up and a cure-rate model analysis to estimate the fraction of patients expected to remain relapse free long term.
METHODS


In this phase III trial, patients with resected  BRAF  V600-mutant stage III melanoma were randomly assigned to 12 months of adjuvant dabrafenib plus trametinib versus placebo. We report updated RFS (primary end point) and distant metastasis-free survival. RFS was also analyzed by subgroups defined by baseline disease stage (American Joint Committee on Cancer 7th and 8th editions), nodal metastatic burden, and ulceration status. The fraction of patients who remained relapse free long term was estimated using a Weibull mixture cure-rate model.
RESULTS


At median follow-up of 44 months (dabrafenib plus trametinib) and 42 months (placebo), 3- and 4-year RFS rates were 59% (95% CI, 55% to 64%) and 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm and 40% (95% CI, 35% to 45%) and 38% (95% CI, 34% to 44%) in the placebo arm, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). Distant metastasis-free survival also favored dabrafenib plus trametinib (HR, 0.53; 95% CI, 0.42 to 0.67). The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm. Subgroup analysis of RFS demonstrated similar treatment benefit regardless of baseline factors, including disease stage, nodal metastatic burden, and ulceration.
CONCLUSION


Longer follow-up confirmed RFS benefit with dabrafenib plus trametinib. Subgroup analysis suggested that dabrafenib plus trametinib benefited patients regardless of baseline factors.",2018,"The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm.","['patients with resected BRAF V600-mutant stage III melanoma', 'Patients']","['placebo', 'adjuvant dabrafenib plus trametinib versus placebo']","['4-year RFS rates', 'RFS', 'nodal metastatic burden, and ulceration status', 'disease stage, nodal metastatic burden, and ulceration', 'estimated cure rate', 'Distant metastasis-free survival', 'relapse-free survival (RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.776619,"The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shilkrut', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01219']
617,32203007,Effects of repleting organic phosphates in banked erythrocytes on plasma metabolites and vasoactive mediators after red cell exchange transfusion in sickle cell disease.,"BACKGROUND


Red blood cell (RBC) exchange (RCE) transfusion therapy is indicated for certain patients with sickle cell disease (SCD). Although beneficial, this therapy is costly and inconvenient to patients, who may require it monthly or more often. Identification of blood and plasma biomarkers that could improve or help individualise RCE therapy is of interest. Here we examined relevant blood and plasma metabolites and biomarkers of vasoactivity and RBC fragility in a pilot study of SCD patients undergoing RCE using either standard RBC units or RBC units treated with a US Food and Drug Administration (FDA)-approved additive solution containing phosphate, inosine, pyruvate, and adenine (""PIPA"").
MATERIALS AND METHODS


In this prospective, single-blind, cross-over pilot clinical trial, patients were randomised to receive either standard RBC exchange or PIPA-treated RBC exchange transfusion with each RCE session over a 6-month treatment period. Pre- and post-transfusion blood samples were obtained and analysed for RBC O 2  affinity, ATP, purine metabolites, RBC microparticles, and cell free haemoglobin.
RESULTS


Red blood cell O 2  affinity was maintained after PIPA-RCE in contrast to standard RCE, after which P 5 0  fell (net O 2  affinity rose). Plasma ATP did not change significantly after RCE using either of the RBC unit types. Exchange transfusion with PIPA-treated RBC units led to modest increases in plasma inosine and hypoxanthine. Plasma cell free haemoglobin fell after either standard or PIPA-treated RBC exchange transfusion (novel findings), and to a similar extent. RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion.
DISCUSSION


In summary, treatment of RBCs with PIPA prior to RCE elicited favourable or neutral changes in key metabolic and vascular biomarkers. Further study of its efficacy and safety is recommended and could ultimately serve to improve outcomes in chronically transfused SCD patients.",2020,"RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion.
","['certain patients with sickle cell disease (SCD', 'SCD patients undergoing RCE using either standard RBC units or RBC units treated with a', 'chronically transfused SCD patients', 'sickle cell disease']","['US Food and Drug Administration (FDA)-approved additive solution containing phosphate, inosine, pyruvate, and adenine (""PIPA', 'repleting organic phosphates', 'Red blood cell (RBC) exchange (RCE) transfusion therapy', 'standard RBC exchange or PIPA-treated RBC exchange transfusion with each RCE session']","['Red blood cell O2 affinity', 'plasma metabolites and vasoactive mediators', 'plasma inosine and hypoxanthine', 'RBC O2 affinity, ATP, purine metabolites, RBC microparticles, and cell free haemoglobin', 'Plasma cell free haemoglobin fell', 'Plasma ATP']","[{'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0244104', 'cui_str': 'Pyruvate'}, {'cui': 'C0001407', 'cui_str': 'Adenine'}, {'cui': 'C0031701', 'cui_str': 'Phosphates, Organic'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0015236', 'cui_str': 'Exchange Transfusion, Whole Blood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C0032112', 'cui_str': 'Plasmacytes'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",,0.0236441,"RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion.
","[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Lopez Domowicz', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Welsby', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Esther', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Marek', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Poisson', 'Affiliation': 'Department of Pathology, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'McMahon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0237-19']
618,32403066,A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors.,"OBJECTIVE


To assess the efficacy of aerobic exercise training to improve controlled attention, information processing speed and neural communication during increasing task load and rest in pediatric brain tumor survivors (PBTS) treated with cranial radiation.
METHODS


Participants completed visual-motor Go and Go/No-Go tasks during magnetoencephalography recording prior to and following the completion of 12-weeks of exercise training. Exercise-related changes in response accuracy and visual-motor latency were evaluated with Linear Mixed models. The Phase Lag Index (PLI) was used to estimate functional connectivity during task performance and rest. Changes in PLI values after exercise training were assessed using Partial Least Squares analysis.
RESULTS


Exercise training predicted sustained (12-weeks) improvement in response accuracy (p<0.05) during No-Go trials. Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials. Significant changes in response latency and resting state connectivity were not detected.
CONCLUSION


These findings support the efficacy of aerobic exercise to improve controlled attention and enhance functional mechanisms under increasing task load in participants.
SIGNIFICANCE


It may be possible to harness the beneficial effects of exercise as therapy to promote cognitive recovery and enhance brain function in PBTS.",2020,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"['pediatric brain tumor survivors (PBTS) treated with cranial radiation', 'Participants completed visual-motor Go and Go', 'pediatric brain tumor survivors']","['exercise training', 'aerobic exercise', 'Exercise training', 'aerobic exercise training']","['PLI values', 'Phase Lag Index (PLI', 'cognition and neural communication', 'response accuracy and visual-motor latency', 'response accuracy', 'Altered functional connectivity', 'response latency and resting state connectivity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0354978,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: harasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.027']
619,32404355,Aerobic exercise improves cognition and cerebrovascular regulation in older adults.,"OBJECTIVE


To test the hypothesis that aerobic exercise is associated with improvements in cognition and cerebrovascular regulation, we enrolled 206 healthy low-active middle-aged and older adults (mean ± SD age 65.9 ± 6.4 years) in a supervised 6-month aerobic exercise intervention and assessed them before and after the intervention.
METHODS


The study is a quasi-experimental single group pre/postintervention study. Neuropsychological tests were used to assess cognition before and after the intervention. Transcranial Doppler ultrasound was used to measure cerebral blood flow velocity. Cerebrovascular regulation was assessed at rest, during euoxic hypercapnia, and in response to submaximal exercise. Multiple linear regression was used to examine the association between changes in cognition and changes in cerebrovascular function.
RESULTS


The intervention was associated with improvements in some cognitive domains, cardiorespiratory fitness, and cerebrovascular regulation. Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
CONCLUSION


The 6-month aerobic exercise intervention was associated with improvements in some cognitive domains and cerebrovascular regulation. Secondary analyses showed a novel association between changes in cognition and changes in cerebrovascular regulation during euoxic hypercapnia and in response to submaximal exercise.",2020,"Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
","['older adults', '206 healthy low-active middle-aged and older adults (mean ± SD age 65.9 ± 6.4 years) in a']","['aerobic exercise intervention', 'Transcranial Doppler ultrasound', 'Aerobic exercise', 'supervised 6-month aerobic exercise intervention', 'aerobic exercise']","['Cerebrovascular regulation', 'executive functions', 'some cognitive domains and cerebrovascular regulation', 'cognition and cerebrovascular regulation', 'cerebral blood flow velocity', 'cognition and changes in cerebrovascular regulation', 'cerebrovascular resistance index (CVRi', 'some cognitive domains, cardiorespiratory fitness, and cerebrovascular regulation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",206.0,0.0187172,"Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Guadagni', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': 'Drogos', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Amanda V', 'Initials': 'AV', 'LastName': 'Tyndall', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Margie H', 'Initials': 'MH', 'LastName': 'Davenport', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Anderson', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Eskes', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'R Stewart', 'Initials': 'RS', 'LastName': 'Longman', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Hogan', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada. poulin@ucalgary.ca.""}]",Neurology,['10.1212/WNL.0000000000009478']
620,32405286,Personalizing Mobile Fitness Apps using Reinforcement Learning.,"Despite the vast number of mobile fitness applications (apps) and their potential advantages in promoting physical activity, many existing apps lack behavior-change features and are not able to maintain behavior change motivation. This paper describes a novel fitness app called CalFit, which implements important behavior-change features like dynamic goal setting and self-monitoring. CalFit uses a reinforcement learning algorithm to generate personalized daily step goals that are challenging but attainable. We conducted the Mobile Student Activity Reinforcement (mSTAR) study with 13 college students to evaluate the efficacy of the CalFit app. The control group (receiving goals of 10,000 steps/day) had a decrease in daily step count of 1,520 (SD ± 740) between baseline and 10-weeks, compared to an increase of 700 (SD ± 830) in the intervention group (receiving personalized step goals). The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.",2018,"The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.",['13 college students'],['Mobile Student Activity Reinforcement (mSTAR'],['daily steps'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.018296,"The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.","[{'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Mintz', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Physiological Nursing Institute for Health & Aging, School of Nursing University of California, San Francisco, CA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Goldberg', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Flowers', 'Affiliation': 'Department of Physiological Nursing, School of Nursing University of California, San Francisco, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kaminsky', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Castillejo', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Aswani', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}]",CEUR workshop proceedings,[]
621,32150758,Comparing TEE- vs Non-TEE-guided cardioversion of atrial fibrillation: The ENSURE-AF trial.,"BACKGROUND


ENSURE-AF (NCT02072434) assessed therapy with edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV).
OBJECTIVES


To evaluate clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality during study period) and safety endpoints (composite of major and clinically relevant nonmajor bleeding during on-treatment period) in patients awaiting ECV of AF with a transesophageal echocardiography (TEE)-guided vs a non-TEE-guided strategy.
METHODS


In this prospective, randomized, open-label, blinded endpoint study, 2199 patients were randomized to edoxaban 60 mg once-daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤60 kg and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Primary efficacy endpoint and safety endpoint were reported. Associates of TEE use, efficacy endpoint and safety endpoint were explored using multivariable logistic regression.
RESULTS


In total, 589 patients from the edoxaban stratum and 594 from the enoxaparin-warfarin stratum were allocated to the TEE-guided strategy. Primary efficacy was similar regardless of TEE approach (P = .575). There were no significant differences in bleeding rates, regardless of TEE approach (P = .677). Independent predictors of TEE use were as follows: history of ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease. Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint whilst mean age was an independent predictor of the safety endpoint.
CONCLUSIONS


Thromboembolic and bleeding events were not different between patients undergoing TEE-guided strategy and in those undergoing an optimized conventional anticoagulation approach for ECV of AF.",2020,Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint,"['patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV', '2199 patients', 'patients awaiting ECV of AF with a', '589 patients from the edoxaban stratum and 594 from the enoxaparin-warfarin stratum']","['TEE', 'enoxaparin-warfarin', 'transesophageal echocardiography (TEE)-guided versus a non-TEE guided strategy', 'TEE-guided strategy', 'edoxaban 60 mg once daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤60 kg, and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin', 'edoxaban']","['ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease', 'Thromboembolic and bleeding events', 'clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality', 'Mean CHA 2  DS 2  VASc and HAS-BLED score', 'bleeding rates, regardless of TEE approach']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018824', 'cui_str': 'Valvular Heart Diseases'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3875442', 'cui_str': 'HAS-BLED score'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",2199.0,0.0580301,Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kozieł', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Arrhythmia and Robotic Electrophysiology Unit, Hospital Universitario La Paz, Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Institute of Cardiology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Medical School, Sigmund Freud University, Vienna, Austria.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Melino', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'St. Vincenz-Hospital, Paderborn, Paderborn, Germany and Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical investigation,['10.1111/eci.13221']
622,32222935,Rating of camera navigation skills in colorectal surgery.,"PURPOSE


In advanced minimally invasive surgery the laparoscopic camera navigation (LCN) quality can influence the flow of the operation. This study aimed to investigate the applicability of a scoring system for LCN (SALAS score) in colorectal surgery and whether an adequate scoring can be achieved using a specified sequence of the operation.
METHODS


The score was assessed by four blinded raters using synchronized video and voice recordings of 20 randomly selected laparoscopic colorectal surgeries (group A: assessment of the entire operation; group B: assessment of the 2nd and 3rd quartile). Experience in LCN was defined as at least 100 assistances in complex laparoscopic procedures.
RESULTS


The surgical teams consisted of three residents, three fellows, and two attendings forming 15 different teams. The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9). Regarding the total SALAS score, the four raters discriminated between experienced and inexperienced camera assistants, regardless of their group assignment (group A, p < 0.05; group B, p < 0.05). The score's interrater variability and reliability were proven with an intraclass correlation coefficient of 0.88. No statistically relevant correlation was achieved between operation time and SALAS score.
CONCLUSION


This study presents the first intraoperative, objective, and structured assessment of LCN in colorectal surgery. We could demonstrate that the SALAS score is a reliable tool for the assessment of LCN even when only the middle part (50%) of the procedure is analyzed. Construct validity was proven by discriminating between experienced and inexperienced camera assistants.",2020,The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9).,['colorectal surgery'],"['synchronized video and voice recordings of 20 randomly selected laparoscopic colorectal surgeries', 'camera navigation skills', 'LCN', 'laparoscopic camera navigation (LCN']","['total SALAS score', 'operation time and SALAS score']","[{'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.0358915,The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huettl', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paschold', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Watzka', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wachter', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hensel', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kneist', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Huber', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. Tobias.Huber@unimedizin-mainz.de.'}]",International journal of colorectal disease,['10.1007/s00384-020-03543-9']
623,32217200,Kinematic gait parameters for older adults with Parkinson's disease during street crossing simulation.,"Safe street crossing is important for older adults' social inclusion. We assessed gait kinematic adaptation under different simulated street crossing conditions in older adults with Parkinson's disease (PD) and made comparisons with older adults without PD to understand how PD interferes in outdoor task performance, helping in the development of strategies to reduce road traffic accident risk. In 20 older adults without PD (control group - CG) and 20 with PD (GPD), we assessed usual gait (C1), gait during street crossing simulation (C2), and gait during reduced-time street crossing simulation (C3). Velocity, step length, and step, swing, stance, and double support time were analyzed. Spatiotemporal differences in gait between groups and conditions were analyzed. The GPD walked 16% slower in C1 and 12% slower in C2 and C3 than the CG. GPD also took 11% shorter steps in C1 and 9.5% shorter steps in C2. The double support time was 8.5% greater in C1. In intragroup comparisons, there were significant differences in all gait conditions. The CG showed increased velocity (C2 15% > C1; C3 13% > C2; C3 26% > C1), step length (C2 8% > C1; C3 5% > C2; C3 13% > C1), and swing time (C2 2% > C1; C3 3.7% > C2; C3 6% > C1), and decreased step time (C2 7.5% < C1; C3 8% < C2; C3 15% < C1), stance time (C2 1.3% < C1; C3 2.5% < C2; C3 3.6% < C1), and double support time (C2 6.3% < C1; C3 10.5% < C2; C3 16% < C1). GPD showed increased velocity (C2 19% > C1; C3 13.5% > C2; C3 29.7% > C1), step length, (C2 6% > C1; C3 7% > C2; C3 16% > C1), and swing time (C2 3% > C1; C3 3% > C2; C3 5.5% > C1) and decreased step time (C2 10.3% < C1; C3 7.7% < C2; C3 17% < C1), stance time (C2 1.7% < C1; C3 1.7% < C2; C3 3.4% < C1), and double support time (C2 7% < C1; C3 9.5% < C2; C3 16% < C1). Kinematic changes observed in the intergroup comparison show that participants with PD had lower velocity in all conditions. However, per the intragroup results, both participants with and without PD managed to significantly modify gait variables to attempt to cross the street in the given time. It is necessary to assess whether this increases fall risk by exposing them to road traffic accidents.",2020,"GPD showed increased velocity (C2 19% > C1; C3 13.5% > C2; C3 29.7% > C1), step length, (C2 6% > C1; C3 7% > C2; C3 16% > C1), and swing time (C2 3% > C1; C3 3% > C2; C3 5.5% > C1) and decreased step time (C2 10.3% ","['20 older adults without PD (control group - CG) and 20 with PD (GPD', ""older adults with Parkinson's disease during street crossing simulation"", ""older adults with Parkinson's disease (PD""]",[],"['stance time', 'Kinematic gait parameters', 'double support time', 'usual gait (C1), gait during street crossing simulation (C2), and gait during reduced-time street crossing simulation (C3', 'velocity', 'gait kinematic adaptation', 'GPD', 'swing time', 'step time', 'Velocity, step length, and step, swing, stance, and double support time']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}]",20.0,0.0163187,"GPD showed increased velocity (C2 19% > C1; C3 13.5% > C2; C3 29.7% > C1), step length, (C2 6% > C1; C3 7% > C2; C3 16% > C1), and swing time (C2 3% > C1; C3 3% > C2; C3 5.5% > C1) and decreased step time (C2 10.3% ","[{'ForeName': 'Késia Maísa do', 'Initials': 'KMD', 'LastName': 'Amaral-Felipe', 'Affiliation': 'Institute of Biosciences, São Paulo State University (UNESP), Avenida vinte e quatro A, 1515, CEP 13506-900 Rio Claro, São Paulo, Brazil; Faculty Anhanguera of Jundiaí, Rua do Retiro, 3000, CEP 13209-002 Jundiaí, São Paulo, Brazil. Electronic address: kesinha_maisa@hotmail.com.'}, {'ForeName': 'Patrícia de Aguiar', 'Initials': 'PA', 'LastName': 'Yamada', 'Affiliation': 'Institute of Biosciences, São Paulo State University (UNESP), Avenida vinte e quatro A, 1515, CEP 13506-900 Rio Claro, São Paulo, Brazil; Faculty of Higher Education of Interior São Paulo (FAIP), Avenida Antonieta Altenfelder, 65, CEP 17512-130 Marília, São Paulo, Brazil.'}, {'ForeName': 'Daniela Cristina Carvalho de', 'Initials': 'DCC', 'LastName': 'Abreu', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Equilibrium, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine of Ribeirão Preto, University of São Paulo, Avenida Bandeirantes, 3900, CEP 14049-900 Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Renato Campos', 'Initials': 'RC', 'LastName': 'Freire Júnior', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Equilibrium, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine of Ribeirão Preto, University of São Paulo, Avenida Bandeirantes, 3900, CEP 14049-900 Ribeirão Preto, São Paulo, Brazil; Faculty of Physical Education and Physiotherapy, Federal University of Amazonas, Avenida General Rodrigo Octavio Jordão Ramos, 1200, CEP 69067-005 Manaus, Amazonas, Brazil.'}, {'ForeName': 'Ana Elisa Zuliani', 'Initials': 'AEZ', 'LastName': 'Stroppa-Marques', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, School of Philosophy and Science, São Paulo State University (UNESP), Avenida Hygino Muzzi FIlho, 737, CEP 17525-000 Marília, São Paulo, Brazil.'}, {'ForeName': 'Flávia Roberta', 'Initials': 'FR', 'LastName': 'Faganello-Navega', 'Affiliation': 'Institute of Biosciences, São Paulo State University (UNESP), Avenida vinte e quatro A, 1515, CEP 13506-900 Rio Claro, São Paulo, Brazil; Department of Physical Therapy and Occupational Therapy, School of Philosophy and Science, São Paulo State University (UNESP), Avenida Hygino Muzzi FIlho, 737, CEP 17525-000 Marília, São Paulo, Brazil.'}]",Human movement science,['10.1016/j.humov.2020.102599']
624,32217211,Quantifying lower limb inter-joint coordination and coordination variability after four-month wearing arch support foot orthoses in children with flexible flat feet.,"INTRODUCTION


Flat feet in children negatively affect lower limb alignment and cause adverse health-related problems. The long-term application of foot orthoses (FOs) may have the potential to improve lower limb coordination and its variability.
AIM


To evaluate the effects of long-term use of arch support FOs on inter-joint coordination and coordination variability in children with flexible flat feet.
METHODS


Thirty boys with flexible flat feet were randomly assigned to the experimental (EG) and control groups. The EG used medial arch support FOs during daily activities over a four-month period while the control group received a flat 2-mm-thick insole for the same time period. Lower-limb coordination and variability during the 3 sub-stance phases were quantified using a vector coding technique.
RESULTS


Frontal plane ankle-hip coordination in EG during mid-stance changed to an anti-phase pattern (156.9 ° ) in the post-test compared to an in-phase (221.1 ° ) in the pre-test of EG and post-test of CG (222.7). Frontal plane knee-hip coordination in EG during loading response (LR) changed to an anti-phase pattern (116 ° ) in the post-test compared to an in-phase (35.5 ° ) in the pre-test of EG and post-test of CG (35.3). Ankle inversion/eversion-knee internal/external rotation joint coupling angle in EG changed to an in-phase pattern (59 ° ) in the post-test compared to a proximal phase (89 ° ) in the pre-test. Coupling angle variability increased in the post-test of EG for sagittal plane ankle-hip during push-off, transverse plane ankle-hip during LR and mid-stance, and transverse plane knee-hip during LR and mid-stance compared to pre-test of EG and post-test of CG.
CONCLUSION


The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet. This new insight into coordinative function may be useful for improving corrective exercise strategies planned for children with flat feet.",2020,The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet.,"['Thirty boys with flexible flat feet', 'children with flexible flat feet', 'children with flat feet']","['Ankle inversion/eversion-knee internal/external rotation joint coupling angle', 'foot orthoses (FOs', 'CG']","['Coupling angle variability', 'limb coordination and coordination variability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",30.0,0.0198977,The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet.,"[{'ForeName': 'AmirAli', 'Initials': 'A', 'LastName': 'Jafarnezhadgero', 'Affiliation': 'University of Mohaghegh Ardabili, Faculty of Educational Sciences and Psychology, Department of Physical Education and Sport Sciences, Ardabil, Iran.'}, {'ForeName': 'Seyed Hamed', 'Initials': 'SH', 'LastName': 'Mousavi', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, the Netherlands; University of Tehran, Faculty of Physical Education and Sport Sciences, Department of Health and Sport Medicine, Tehran, Iran. Electronic address: s.h.mousavi@umcg.nl.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Madadi-Shad', 'Affiliation': 'Bu-Ali Sina University, Department of Sport Biomechanics, Hamedan, Iran.'}, {'ForeName': 'Juha M', 'Initials': 'JM', 'LastName': 'Hijmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, the Netherlands.'}]",Human movement science,['10.1016/j.humov.2020.102593']
625,32213342,"Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.","BACKGROUND


Intravenous daratumumab for treatment of patients with multiple myeloma involves a lengthy infusion that affects quality of life, and infusion-related reactions are common. Subcutaneous daratumumab is thought to be easier to administer and to cause fewer administration-related reactions. In this study (COLUMBA), we tested the non-inferiority of subcutaneous daratumumab to intravenous daratumumab.
METHODS


In this ongoing, multicentre (147 sites in 18 countries), open-label, non-inferiority, randomised, phase 3 trial, we recruited adult patients (age ≥18 years) if they had confirmed relapsed or refractory multiple myeloma according to International Myeloma Working Group criteria; received at least three previous lines of therapy, including a proteasome inhibitor and immunomodulatory drug, or were double refractory to both a proteasome inhibitor and immunomodulatory drug; and had an Eastern Cooperative Oncology Group performance status score of 2 or lower. Patients were randomly assigned (1:1) by a computer-generated randomisation schedule and balanced using randomly permuted blocks to receive daratumumab subcutaneously (subcutaneous group) or intravenously (intravenous group). Randomisation was stratified on the basis of baseline bodyweight (≤65 kg, 66-85 kg, >85 kg), previous therapy lines (≤four vs >four), and myeloma type (IgG vs non-IgG). Patients received 1800 mg of subcutaneous daratumumab co-formulated with 2000 U/mL recombinant human hyaluronidase PH20 or 16 mg/kg of intravenous daratumumab once weekly (cycles 1-2), every 2 weeks (cycles 3-6), and every 4 weeks thereafter (28-day cycles) until progressive disease or toxicity. The co-primary endpoints were overall response and maximum trough concentration (C trough ; cycle 3, day 1 pre-dose). The non-inferiority margin for overall response was defined using a 60% retention of the lower bound (20·8%) of the 95% CI of the SIRIUS trial. Efficacy analyses were done by intention-to-treat population. The pharmacokinetic-evaluable population included all patients who received all eight weekly daratumumab doses in cycles 1 and 2 and provided a pre-dose pharmacokinetics blood sample on day 1 of cycle 3. The safety population included all patients who received at least one daratumumab dose. This trial is registered with ClinicalTrials.gov, NCT03277105.
FINDINGS


Between Oct 31, 2017, and Dec 27, 2018, 655 patients were screened, of whom 522 were recruited and randomly assigned (subcutaneous group n=263; intravenous group n=259). Three patients in the subcutaneous group and one in the intravenous group did not receive treatment and were not evaluable for safety. At a median follow-up of 7·5 months (IQR 6·5-9·3), overall response and C trough  met the predefined non-inferiority criteria. An overall response was seen in 108 (41%) of 263 patients in the subcutaneous group and 96 (37%) of 259 in the intravenous group (relative risk 1·11, 95% CI 0·89-1·37). The geometric means ratio for C trough  was 107·93% (90% CI 95·74-121·67), and the maximum C trough  was 593 μg/mL (SD 306) in the subcutaneous group and 522 μg/mL (226) in the intravenous group. The most common grade 3 and 4 adverse events were anaemia (34 [13%] of 260 patients evaluable for safety in the subcutaneous group and 36 [14%] of 258 patients in the intravenous group), neutropenia (34 [13%] and 20 [8%]), and thrombocytopenia (36 [14%] and 35 [14%]). Pneumonia was the only serious adverse event in more than 2% of patients (seven [3%] in the subcutaneous group and 11 [4%] in the intravenous group). There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
INTERPRETATION


Subcutaneous daratumumab was non-inferior to intravenous daratumumab in terms of efficacy and pharmacokinetics and had an improved safety profile in patients with relapsed or refractory multiple myeloma. These data could contribute to the approval of the subcutaneous daratumumab formulation by regulatory bodies.
FUNDING


Janssen Research & Development.",2020,"There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
","['adult patients (age ≥18 years) if they had confirmed relapsed or refractory multiple myeloma according to International Myeloma Working Group criteria', 'patients with relapsed or refractory multiple myeloma', 'patients with relapsed or refractory multiple myeloma (COLUMBA', 'patients with multiple myeloma', 'Between Oct 31, 2017, and Dec 27, 2018, 655 patients were screened, of whom 522 were recruited and randomly assigned (subcutaneous group n=263; intravenous group n=259']","['recombinant human hyaluronidase PH20 or 16 mg/kg of intravenous daratumumab', 'subcutaneous daratumumab co-formulated with 2000', 'U/mL', 'proteasome inhibitor and immunomodulatory drug, or were double refractory to both a proteasome inhibitor and immunomodulatory drug; and had an Eastern Cooperative Oncology Group performance status score of 2 or lower', 'daratumumab subcutaneously (subcutaneous group) or intravenously (intravenous group', 'Subcutaneous versus intravenous daratumumab']","['Pneumonia', 'anaemia', 'geometric means ratio for C trough', 'thrombocytopenia', 'neutropenia', 'overall response', 'overall response and maximum trough concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0999231', 'cui_str': 'Genus Columba'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1720035', 'cui_str': 'hyaluronidase, human recombinant'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",655.0,0.267856,"There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
","[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Cancer Research Unit, University Hospital of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain; Institute of Cancer Molecular and Cellular Biology (USAL-CSIC), Centre for Cancer Research (IBMCC), Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.'}, {'ForeName': 'Hareth', 'Initials': 'H', 'LastName': 'Nahi', 'Affiliation': 'Unit of Hematology, Department of Medicine, Karolinska University Hospital at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Legiec', 'Affiliation': 'Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, School of Public Health in Bytom, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vorobyev', 'Affiliation': 'S P Botkin City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': '1st Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University, Prague, Czech Republic; General University Hospital in Prague, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Sibirina', 'Initials': 'S', 'LastName': 'Korenkova', 'Affiliation': 'Kiev Bone Marrow Transplantation Center, Kiev, Ukraine.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Bahlis', 'Affiliation': 'Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Flogegard', 'Affiliation': 'Department of Internal Medicine, Falun General Hospital, Falun, Sweden.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haemato-Oncology, Royal Marsden Hospital, London, UK; Division of Molecular Pathology, Institute of Cancer Research, London, UK.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Department of Hematology and Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Diagnostic and Specialty Medicine Department, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'Centre Hospitalier Universitaire Bordeaux, Pessac, France.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'De Stefano', 'Affiliation': 'Institute of Hematology, Università Cattolica del Sacro Cuore, Rome, Italy; Fondazione Policlinico Universitario Agostino Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Masterson', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lantz', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Rourke"", 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Dolly A', 'Initials': 'DA', 'LastName': 'Parasrampuria', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA; Genmab US, Princeton, NJ, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute-Atrium Health, Charlotte, NC, USA. Electronic address: saad.usmani@atriumhealth.org.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30070-3']
626,32217042,The effect of different genres of music and silence on relaxation and anxiety: A randomized controlled trial.,"High stress and anxiety in healthy individuals may lead to use different pharmacological and non-pharmacological therapies. The study aimed to investigate the effect of different genres of music on anxiety and relaxation in healthy participants. This study was a randomized controlled trial with a cross-over design. Forty-six healthy undergraduates participated in the study and randomly received different genres of music (Pop, Rock, Western Classical, and Persian Traditional) and silence for five consecutive days between February and June 2018. Each participant was her/his own control. Relaxation and the State Anxiety were checked with Smith Relaxation States Inventory 3 and The State Anxiety Inventory before and after listening to 15 min of music or laying down in silence. None of the five procedures were preferred for a more relaxing effect (P > 0.05). Also, none of the interventions were preferred for reduction of the state anxiety (P > 0.05). Although different genres of music, i.e., Pop, Rock, Western Classical, Persian Traditional, could reduce state anxiety and improve relaxation, they had no extra effect compared to Silence.",2020,None of the five procedures were preferred for a more relaxing effect (P > 0.05).,"['healthy participants', 'Forty-six healthy undergraduates', 'healthy individuals']","['genres of music (Pop, Rock, Western Classical, and Persian Traditional']","['Relaxation and the State Anxiety', 'state anxiety', 'relaxing effect', 'relaxation and anxiety', 'state anxiety and improve relaxation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",46.0,0.0396863,None of the five procedures were preferred for a more relaxing effect (P > 0.05).,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Malakoutikhah', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran; Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft-Bagh Highway, Kerman, Iran. Electronic address: m_dehghan@kmu.ac.ir.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ghonchehpoorc', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Parandeh Afshar', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Honarmand', 'Affiliation': 'University of Tehran, Tehran, Iran. Electronic address: a.honarmand@ut.ac.ir.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.02.005']
627,32217111,Argon plasma coagulation alone versus argon plasma coagulation plus full-thickness endoscopic suturing to treat weight regain after Roux-en-Y gastric bypass: a prospective randomized trial (with videos).,"BACKGROUND AND AIMS


A significant number of patients regain weight after Roux-en-Y gastric bypass. Ablation with argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone have been reported for treating weight regain when associated with gastrojejunostomy (GJ) dilation. However, comparative controlled data are still lacking.
METHODS


This was a pilot single-center open-label randomized trial comparing the effectiveness and safety of APC alone versus FTS-APC for transoral outlet reduction. Patients with at least 20% weight regain from the nadir, and GJ ≥15 mm were considered eligible. The primary outcome was percentage total weight loss (%TWL) at 12 months. Secondary outcomes were the incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life and eating behavior.
RESULTS


Forty patients meeting the eligibility criteria were enrolled from October 2017 to July 2018. Technical and clinical success rates were similar between the groups. At 12 months, the mean %TWL was 8.3% ± 5.5% in the APC alone group versus 7.5% ± 7.7% in the FTS-APC group (P = .71). The pre-revisional % solid gastric retention at 1 hour positively correlated with the probability of achieving ≥10% TWL at 12 months. Both groups experienced significant reductions in low-density lipoprotein and triglyceride levels at 12 months, and improvement in eating behavior and quality of life at 3 months. There were 2 cases of stenoses (1 from each group), which were successfully treated with endoscopic balloon dilation.
CONCLUSION


APC alone is similar to FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up. (Clinical trial registration number: NCT03094936.).",2020,The APC alone is similar to the FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up.,"['patients regain weight after Roux-en-Y gastric bypass (RYGB', 'Forty patients meeting eligibility criteria were enrolled from October 2017 to July 2018', 'after Roux-en-Y gastric bypass', 'Patients with at least 20% weight regain from the nadir, and GJ ≥15 mm were considered eligible']","['argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone', 'endoscopic balloon dilation', 'APC alone versus FTS-APC', 'FTS-APC', 'Argon plasma coagulation alone versus endoscopic suturing plus argon plasma coagulation']","['weight regain', 'total weight loss', 'eating behavior and QOL', 'incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life (QOL) and eating behavior', 'LDL and triglycerides levels', 'Technical and clinical success rates', 'prerevisional % solid gastric retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0585136', 'cui_str': 'Gastric retention (disorder)'}]",40.0,0.0755459,The APC alone is similar to the FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up.,"[{'ForeName': 'Vitor Ottoboni', 'Initials': 'VO', 'LastName': 'Brunaldi', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil; Center for Gastrointestinal Endoscopy, Surgery and Anatomy Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Galileu Ferreira Ayala', 'Initials': 'GFA', 'LastName': 'Farias', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Daniel Tavares', 'Initials': 'DT', 'LastName': 'de Rezende', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cairo-Nunes', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Riccioppo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Diogo Turiani Hourneaux', 'Initials': 'DTH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.03.3757']
628,31468342,Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial.,"BACKGROUND


General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse.
OBJECTIVE


To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients.
DESIGN


Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057).
PARTICIPANTS


Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital.
INTERVENTIONS


Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition).
MAIN MEASURES


Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse.
KEY RESULTS


20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g = 1.49) and 3.0% (Hedge's g = 1.26) in the respective workshop only and apprenticeship conditions (p < 0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
CONCLUSIONS


Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances.
TRIAL REGISTRY


NCT01825057.",2019,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","['medical inpatients who misuse substances', 'substance misuse with general medical inpatients', 'Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital']","['implementing motivational interviewing', 'Implementing Motivational Interviewing', 'Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition']","['percent of patient statements within the interviews that indicated motivation for reducing substance misuse', 'interview for substance misuse and the integrity (adherence, competence) of the interviews']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0369919', 'cui_str': 'Reducing substances (substance)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0448512,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. steve.martino@yale.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joy S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Desan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B. Johnson School of Public Affairs, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05257-3']
629,31743406,Instillation of 5% Povidone-Iodine Ophthalmic Drops Decreases the Respiratory Rate in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.,"PURPOSE


To investigate the effects of topical application of ophthalmic 5% povidone-iodine eye drops, which has been reported to cause apnea in spontaneously breathing children during general anesthesia.
METHODS


The authors conducted a randomized, controlled, single-blinded study comparing the effect of balanced salt solution eye drops and povidone-iodine eye drops on respiration in spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway. Fifty patients received balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops.
RESULTS


None of the control patients had a significant change in respiration. Thirty of the 50 (60%) povidone-iodine patients had a slowing of respiration within the first 6 breaths after eye drop instillation (P < .001). The median time of respiratory pause in those 30 patients was 18.5 seconds (range: 4.36 to 96.2 seconds). Among the povidone-iodine patients, children with a history of a prior tonsillectomy and adenoidectomy and/or bilateral myringotomy had a 7.2 times greater chance of experiencing a change in respiration after instillation of the povidone-iodine eye drops.
CONCLUSIONS


Topical application of 5% povidone-iodine eye drops causes a slowing and pause in spontaneous ventilation in a majority of children prior to strabismus surgery. This may represent activation of the diving reflex. [J Pediatr Ophthalmol Strabismus. 2019;56(6):378-382.].",2019,None of the control patients had a significant change in respiration.,"['Children Undergoing Strabismus Surgery', 'children prior to strabismus surgery', 'Fifty patients received', 'spontaneously breathing children during general anesthesia', 'patients, children with a history of a prior tonsillectomy and', 'spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway']","['povidone-iodine eye drops', 'povidone-iodine', 'adenoidectomy and/or bilateral myringotomy', 'Povidone-Iodine Ophthalmic Drops', 'ophthalmic 5% povidone-iodine eye drops', 'balanced salt solution eye drops and povidone-iodine eye drops', 'balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops']","['chance of experiencing a change in respiration', 'slowing of respiration', 'median time of respiratory pause', 'respiration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0087123', 'cui_str': 'Myringostomy'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",50.0,0.174816,None of the control patients had a significant change in respiration.,"[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rovner', 'Affiliation': ''}, {'ForeName': 'Bethany Jacobs', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Wester', 'Affiliation': ''}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Furse', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20190923-01']
630,32207134,"Comparison of Safety and Efficiency of General, Spinal and Epidural Anesthesia Methods Used for the Endoscopic Surgical Treatment of Ureteral Stones: Which One is Better To Access The Ureter and Reach The Stone?","PURPOSE


The aim of this study is to evaluate the effects of anesthesia methods on the success of urethral access and stone access achievement in endoscopic treatment of urolithiasis.
MATERIALS AND METHODS


In this prospective randomized study, 105 patients who underwent primary ureterorenoscopy (URS) procedure for ureteral stones were evaluated. The patients were randomized into three groups by permuted block randomization according to the applied anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA): 31 patients. Ten patients, whose ureteral access was not successful, were dropped out. The success of the three anesthesia methods on the success of the ureter access and its effects on surgical outcomes were compared.
RESULTS


There was no statistically significant difference among the three groups in terms of the demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status. Dilatation and the access time to stone were statistically significantly longer in SA and EA group compared to the GA group. There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates. The Visual Analog Scale (VAS) scores in the 8th and 24th hours were statistically significantly higher in the GA group.
CONCLUSION


In patients who decided to undergo primary ureterorenoscopy procedure, it can be suggested to treat with GA to provide a better relaxation of the ureter if there are no contraindications.",2020,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","['Ureteral Stones', '105 patients who underwent primary URS procedure for ureteral stones were evaluated']","['anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA']","['Visual Analog Scale (VAS) scores', 'operation, lithotripsy time, stone-free rate (SFR), and complication rates', 'demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status', 'Dilatation and the access time to stone']","[{'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",105.0,0.0339014,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","[{'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Oztekin', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY. dr_unal@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Caniklioglu', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atac', 'Affiliation': 'Kırıkkale University, Faculty of Medicine, Department of Urology, Kırıkkale, TURKEY.'}, {'ForeName': 'Cigdem Unal', 'Initials': 'CU', 'LastName': 'Kantekin', 'Affiliation': 'Yozgat Bozok University, Faculty of Medicine, Department of Anesthesiology, Yozgat, TURKEY.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gurel', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Isikay', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.5638']
631,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
632,31506734,"Comparison of torque, force generation and canal shaping ability between manual and nickel-titanium glide path instruments in rotary and optimum glide path motion.","This study aimed to analyze force/torque generation and canal volume changes of NiTi rotary glide path preparation using HyFlex EDM Glide Path File in comparison to manual stainless steel K-file instrumentation. Thirty extracted mandibular incisors with a minimally curved and narrow root canal were randomly divided into three groups (n = 10) according to the instrumentation kinematics: Optimum Glide Path motion (OGP) or continuous rotation (CR) with HyFlex EDM Glide Path Files using a custom-made automated-root-canal-preparation device and manual instrumentation with stainless steel K-files (SS) in watch-winding motion. Torque and force were monitored with a custom-made torque/force analyzing device. Canal volume changes and transportation values were measured on micro-computed tomographic images taken before and after the glide path preparation. The data were statistically evaluated using Kruskal-Wallis test and Mann-Whitney U test with Bonferroni correction, with a significance level set at 5%. Maximum upward apical force, representing the screw-in force, was lower in groups OGP and CR compared with that in group SS (P < 0.05). Group CR showed the highest maximum clockwise torque value and canal volume changes, followed by groups OGP and SS (P < 0.05). Canal transportation values at 1 and 3 mm from the apex were not significantly different among groups. Within the limitations of this study, rotary glide path preparation generated smaller screw-in force, larger torque and larger canal volume changes than manual preparation. OGP motion generated smaller torque and less canal volume changes than CR.",2020,"Maximum upward apical force, representing the screw-in force, was lower in groups OGP and CR compared with that in group SS (P < 0.05).",['Thirty extracted mandibular incisors with a minimally curved and narrow root canal'],['instrumentation kinematics: Optimum Glide Path motion (OGP) or continuous rotation (CR) with HyFlex EDM Glide Path Files using a custom-made automated-root-canal-preparation device and manual instrumentation with stainless steel K-files (SS'],"['Canal transportation values', 'highest maximum clockwise torque value and canal volume changes', 'Canal volume changes and transportation values']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}]","[{'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0282543', 'cui_str': 'Root Canal Preparation'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}]","[{'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",30.0,0.0163742,"Maximum upward apical force, representing the screw-in force, was lower in groups OGP and CR compared with that in group SS (P < 0.05).","[{'ForeName': 'Pyae Hein', 'Initials': 'PH', 'LastName': 'Htun', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Ebihara', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan. a.ebihara.endo@tmd.ac.jp.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Maki', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kimura', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Nishijo', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Tokita', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okiji', 'Affiliation': 'Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}]",Odontology,['10.1007/s10266-019-00455-1']
633,31083046,Effects of Instrument-assisted Soft Tissue Mobilization on Musculoskeletal Properties.,"PURPOSE


Instrument-assisted soft tissue mobilization (IASTM) has been reported to improve joint range of motion (flexibility). However, it is not clear whether this change in the joint range of motion is accompanied by any alterations in the mechanical and/or neural properties. This study aimed to investigate the effects of IASTM in plantarflexors and Achilles tendon on the mechanical and neural properties of them.
METHODS


This randomized, controlled, crossover study included 14 healthy volunteers (11 men and 3 women, 21-32 yr). IASTM was performed on the skin over the posterior part of the lower leg for 5 min and targeted the soft tissues (gastrocnemii, soleus, and tibialis posterior muscles; overlying deep fascia; and Achilles tendon). As a control condition, the same participants rested for 5 min between pre- and postmeasurements without IASTM on a separate day. The maximal ankle joint dorsiflexion angle (dorsiflexion range of motion), the peak passive torque (stretch tolerance), and the ankle joint stiffness (slope of the relationship between passive torque and ankle joint angle) during the measurement of the dorsiflexion range of motion and muscle stiffness of the triceps surae (using shear wave elastography) were measured before and immediately after the interventions.
RESULTS


After IASTM, the dorsiflexion range of motion significantly increased by 10.7% ± 10.8% and ankle joint stiffness significantly decreased by -6.2% ± 10.1%. However, peak passive torque and muscle stiffness did not change. All variables remained unchanged in the repeated measurements of controls.
CONCLUSION


IASTM can improve joint range of motion, without affecting the mechanical and neural properties of the treated muscles.",2019,"Following IASTM, the dorsiflexion range of motion significantly increased by 10.7 ± 10.8% and ankle joint stiffness significantly decreased by -6.2 ± 10.1%.","['14 healthy volunteers (11 men and 3 women, 21-32 y']","['IASTM', 'Instrument-assisted Soft Tissue Mobilization', 'assisted soft tissue mobilization (IASTM']","['dorsiflexion range of motion', 'ankle joint stiffness', 'maximal ankle joint dorsiflexion angle (dorsiflexion range of motion), peak passive torque (stretch tolerance), and ankle joint stiffness (slope of the relationship between passive torque and ankle joint angle) during measurement of dorsiflexion range of motion and muscle stiffness of the triceps surae (using shear wave elastography', 'Musculoskeletal Properties', 'peak passive torque and muscle stiffness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}]","[{'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",14.0,0.0265722,"Following IASTM, the dorsiflexion range of motion significantly increased by 10.7 ± 10.8% and ankle joint stiffness significantly decreased by -6.2 ± 10.1%.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama, JAPAN.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Otsuka', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Saitama, JAPAN.'}, {'ForeName': 'Yozo', 'Initials': 'Y', 'LastName': 'Kawanishi', 'Affiliation': 'Graston Technique Japan, Inc., Tokyo, JAPAN.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kawakami', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002035']
634,32220916,"Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA 1c , in Patients With Type 2 Diabetes.","OBJECTIVE


To examine the effect of combination therapy with canagliflozin plus liraglutide on HbA 1c , endogenous glucose production (EGP), and body weight versus each therapy alone.
RESEARCH DESIGN AND METHODS


Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion, after which they were randomized to receive  1 ) liraglutide 1.2 mg/day (LIRA),  2 ) canagliflozin 100 mg/day (CANA), or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA) for 16 weeks. At 16 weeks, the EGP measurement was repeated.
RESULTS


The mean decrease from baseline to 16 weeks in HbA 1c  was -1.67 ± 0.29% ( P  = 0.0001), -0.89 ± 0.24% ( P  = 0.002), and -1.44 ± 0.39% ( P  = 0.004) in patients receiving CANA/LIRA, CANA, and LIRA, respectively. The decrease in body weight was -6.0 ± 0.8 kg ( P  < 0.0001), -3.5 ± 0.5 kg ( P  < 0.0001), and -1.9 ± 0.8 kg ( P  = 0.03), respectively. CANA monotherapy caused a 9% increase in basal rate of EGP ( P  < 0.05), which was accompanied by a 50% increase ( P  < 0.05) in plasma glucagon-to-insulin ratio. LIRA monotherapy reduced plasma glucagon concentration and inhibited EGP. In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
CONCLUSIONS


These results demonstrate that liraglutide failed to block the increase in EGP caused by canagliflozin despite blocking the rise in plasma glucagon and preventing the decrease in plasma insulin concentration caused by canagliflozin. The failure of liraglutide to prevent the increase in EGP caused by canagliflozin explains the lack of additive effect of these two agents on HbA 1c .",2020,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","['Patients With Type 2 Diabetes', 'Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on']","['Canagliflozin Plus Liraglutide', 'liraglutide', 'liraglutide 1.2 mg/day (LIRA);  2 ) canagliflozin 100 mg/day (CANA); or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA', 'canagliflozin plus liraglutide', 'metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion', 'LIRA monotherapy']","['Weight Loss', 'plasma glucagon concentration', 'HbA 1c , endogenous glucose production (EGP), and body weight', 'plasma insulin concentration', 'plasma insulin response', 'plasma glucagon-to-insulin ratio', 'body weight', 'basal rate of EGP', 'EGP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3556805', 'cui_str': 'canagliflozin 100 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",45.0,0.0331542,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","[{'ForeName': 'Ali Muhammed', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}]",Diabetes care,['10.2337/dc18-2460']
635,31407810,"Randomised clinical trial: a placebo-controlled study of subcutaneous or intradermal NEXVAX2, an investigational immunomodulatory peptide therapy for coeliac disease.","BACKGROUND


Nexvax2 contains three gluten-derived peptides, intended to tolerize coeliac disease patients to gluten. Sequences cover six epitopes that trigger immune activation in human leucocyte antigen-DQ2.5-positive patients, most notably after an initial dose. Patients experience gastrointestinal symptoms with increases in serum interleukin-2. Consistent with Nexvax2's induction of non-responsiveness, reactivity disappears after repeated doses, or is avoided with gradual dose escalation. Early clinical trials used intradermal dosing, but pharmacokinetics and rapid onset of effect suggest that subcutaneous delivery may also be effective.
AIMS


To document the relative bioavailability of Nevax2 peptides after subcutaneous and intradermal dosing, and the tolerability and ability of subcutaneous dosing to induce non-responsiveness to Nexvax2 peptides.
METHODS


A randomised, double-blind, placebo-controlled study was conducted to assess plasma pharmacokinetics after subcutaneous and intradermal Nexvax2 dosing in HLA DQ2.5-positive patients, who had symptoms after an oral gluten challenge. Randomisation was to semi-weekly Nexvax2 (n = 12) or placebo (n = 2) injections, over a 5-week subcutaneous dose escalation and 2-week maintenance period, the latter with four doses of 900 µg, two subcutaneous and two intradermal. Post-dose circulating peptide and interleukin-2 levels were assessed. Investigators recorded adverse events experienced by patients.
RESULTS


Subcutaneous dosing resulted in slightly greater exposure. Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg. Adverse events were generally mild and self-limited.
CONCLUSIONS


Subcutaneous and intradermal dosing of Nexvax2 yield similar bioavailability of constituent peptides; subcutaneous dose escalation avoids an immune response to dominant gluten epitopes.",2019,Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg.,"['coeliac disease', 'HLA DQ2.5-positive patients, who had symptoms after an oral gluten challenge']","['subcutaneous and intradermal Nexvax2', 'placebo', 'subcutaneous or intradermal NEXVAX2']","['Interleukin-2 responses', 'plasma pharmacokinetics', 'serum interleukin-2', 'Adverse events']","[{'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.34733,Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg.,"[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Truitt', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'A James M', 'Initials': 'AJM', 'LastName': 'Daveson', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Hooi C', 'Initials': 'HC', 'LastName': 'Ee', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Goel', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Prometrika, LLC, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Neff', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Anderson', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15435']
636,31885286,Islet Harvest in Carbon Monoxide-Saturated Medium for Chronic Pancreatitis Patients Undergoing Islet Autotransplantation.,"Stresses encountered during human islet isolation lead to unavoidable β-cell death after transplantation. This reduces the chance of insulin independence in chronic pancreatitis patients undergoing total pancreatectomy and islet autotransplantation. We tested whether harvesting islets in carbon monoxide-saturated solutions is safe and can enhance islet survival and insulin independence after total pancreatectomy and islet autotransplantation. Chronic pancreatitis patients who consented to the study were randomized into carbon monoxide (islets harvested in a carbon monoxide-saturated medium) or control (islets harvested in a normal medium) groups. Islet yield, viability, oxygen consumption rate, β-cell death (measured by unmethylated insulin DNA), and serum cytokine levels were measured during the peri-transplantation period. Adverse events, metabolic phenotypes, and islet function were measured prior and at 6 months post-transplantation. No adverse events directly related to the infusion of carbon monoxide islets were observed. Carbon monoxide islets showed significantly higher viability before transplantation. Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls. Three in 10 (30%) of the carbon monoxide subjects and none of the control subjects were insulin independent. This pilot trial showed for the first time that harvesting human islets in carbon monoxide-saturated solutions is safe for total pancreatectomy and islet autotransplantation patients.",2019,"Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls.","['Chronic pancreatitis patients who consented to the study were randomized into', 'Chronic Pancreatitis Patients Undergoing Islet Autotransplantation', 'total pancreatectomy and islet autotransplantation patients', 'chronic pancreatitis patients undergoing total pancreatectomy and islet autotransplantation']","['carbon monoxide (islets harvested in a carbon monoxide-saturated medium) or control (islets harvested in a normal medium', 'Carbon monoxide islets', 'carbon monoxide islets', 'Islet Harvest in Carbon Monoxide-Saturated Medium', 'harvesting islets in carbon monoxide-saturated solutions', 'carbon monoxide-saturated solutions']","['carbon monoxide islets', 'β-cell death, decreased CCL23, and increased CXCL12 levels', 'Islet yield, viability, oxygen consumption rate, β-cell death (measured by unmethylated insulin DNA), and serum cytokine levels', 'Adverse events, metabolic phenotypes, and islet function']","[{'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy (procedure)'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0522534', 'cui_str': 'Saturated (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0326605,"Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls.","[{'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Gou', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Cloud', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Owzarski', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Shuford', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Luttrell', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lesher', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Klearchos K', 'Initials': 'KK', 'LastName': 'Papas', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Clark', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Usmani-Brown', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kitzmann', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Crosson', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Adams', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Morgan', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}]",Cell transplantation,['10.1177/0963689719890596']
637,31335194,Sotagliflozin Added to Optimized Insulin Therapy Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c at 52 Weeks in Adults with Type 1 Diabetes.,"Background:  Hypoglycemia rates usually increase when insulin treatment is intensified to improve glycemic control. We evaluated (post hoc) hypoglycemic rates in adult patients with type 1 diabetes (T1D) on sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 1 and 2 inhibitor) in two phase 3, 52-week clinical trials (inTandem 1 and 2; NCT02384941 and NCT02421510).  Materials and Methods:  We analyzed rates of documented hypoglycemia (level 1, blood glucose ≥54 to <70 mg/dL) and clinically important hypoglycemia (level 2, glucose <54 mg/dL) in a patient-level pooled analysis ( n  = 1362) using a negative binomial model adjusted for hemoglobin A1c (HbA1c) at 52 weeks in patients receiving placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg.  Results:  Rates of level 1 hypoglycemia events per patient-year were 58.25 (95% confidence interval: 50.26-67.50) with placebo, 44.86 (38.83-51.82;  P  = 0.0138 vs. placebo) with sotagliflozin 200 mg, and 45.68 (39.52-52.81;  P  = 0.0220) with sotagliflozin 400 mg. Sotagliflozin was also associated with lower rates of level 2 hypoglycemia: 15.95 (14.37-17.70), 11.51 (10.39-12.76;  P  < 0.0001), and 11.13 (10.03-12.35;  P  < 0.0001) for placebo and sotagliflozin 200 and 400 mg, respectively. The difference in rates of hypoglycemia with sotagliflozin versus placebo became more pronounced as HbA1c decreased.  Conclusions:  At week 52, level 1 and 2 hypoglycemia events were 22% to 30% less frequent with sotagliflozin added to optimized insulin therapy versus placebo in adults with T1D at any HbA1c level, with greater differences at lower HbA1c values. These findings support the use of sotagliflozin as an insulin adjunct in T1D.",2019,"At week 52, level 1 and 2 hypoglycemia events were 22% to 30% less frequent with sotagliflozin added to optimized insulin therapy versus placebo in adults with T1D at any HbA1c level, with greater differences at lower HbA1c values.","['Adults with Type 1 Diabetes', 'adult patients with type 1 diabetes (T1D) on']","['placebo, sotagliflozin 200\u2009mg, and sotagliflozin 400\u2009mg', 'Sotagliflozin', 'placebo', 'sotagliflozin', 'sotagliflozin (a dual sodium-glucose cotransporter [SGLT']","['hypoglycemia events', 'rates of level 2 hypoglycemia', 'Hypoglycemia rates', 'Results:  Rates of level 1 hypoglycemia events per patient-year', 'hypoglycemic rates', 'rates of hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3896939'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]",1362.0,0.325413,"At week 52, level 1 and 2 hypoglycemia events were 22% to 30% less frequent with sotagliflozin added to optimized insulin therapy versus placebo in adults with T1D at any HbA1c level, with greater differences at lower HbA1c values.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Center, Children and Youth Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'Department of Medicine, University of California San Diego, San Diego, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Center for Endocrine and Metabolic Diseases, Fondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Department of Endocrinology, L'institut du thorax, Nantes, France.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants, Rockville, Maryland.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Rita de Cassia', 'Initials': 'RC', 'LastName': 'Castro', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0157']
638,32209792,Poor Renal and Cardiovascular Outcomes in Patients with Biopsy-Proven Diabetic Nephropathy.,"BACKGROUND


Despite the high mortality of cardiovascular disease (CVD) in diabetic patients with renal injury, few studies have compared cardiovascular characteristics and outcomes between patients with diabetic nephropathy (DN) and non-diabetic renal disease (NDRD).
METHODS


A total of 326 type 2 diabetes mellitus patients with renal biopsy were assigned to DN and NDRD groups. Echocardiography and Doppler ultrasound were performed to evaluate left ventricular hypertrophy (LVH) and peripheral atherosclerosis disease (PAD). Renal and cardiovascular survival rates were compared between the DN and NDRD groups by Kaplan-Meier analysis. Risk factors for renal and cardiovascular events in DN patients were identified by a Cox proportional hazards model.
RESULTS


In total, 179 patients entered the DN group (54.9%) and 147 made up the NDRD group (45.1%). The presence of diabetic retinopathy, family history of diabetes, and dependence on insulin therapy were associated with the presence of DN. DN patients had more CVD with more severe LVH and PAD. Poorer renal (log-rank χ2 = 26.534, p < 0.001) and cardiovascular (log-rank χ2 = 16.257, p < 0.001) prognoses were seen in the DN group. DR (HR 1.539, 95% CI 1.332-1.842), eGFR (HR 0.943, 95% CI 0.919-0.961), and 24-h proteinuria (HR 1.211, 95% CI 1.132-1.387) were identified as risk factors for renal endpoints. Age (HR 1.672, 95% CI 1.487-1.821), HbA1C (HR 1.398, 95% CI 1.197-1.876), and 24-h proteinuria (HR 1.453, 95% CI 1.289-1.672) were associated with cardiovascular endpoints.
CONCLUSION


Patients with DN had more severe CVD along with poorer renal and cardiovascular prognoses than those with NDRD.",2020,"DR (HR 1.539, 95% CI 1.332-1.842), eGFR (HR 0.943, 95% CI 0.919-0.961), and 24-h proteinuria (HR 1.211, 95% CI 1.132-1.387) were identified as risk factors for renal endpoints.","['179 patients entered the DN group (54.9%) and 147 made up the NDRD group (45.1', 'Patients with Biopsy-Proven Diabetic Nephropathy', 'diabetic patients with renal injury', '326 type 2 diabetes mellitus patients with renal biopsy', 'patients with diabetic nephropathy (DN) and non-diabetic renal disease (NDRD']",['Echocardiography and Doppler ultrasound'],"['eGFR', 'Poorer renal', 'severe LVH and PAD', 'cardiovascular', 'Poor Renal and Cardiovascular Outcomes', 'left ventricular hypertrophy (LVH) and peripheral atherosclerosis disease (PAD', '24-h proteinuria', 'Renal and cardiovascular survival rates', 'severe CVD']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}]","[{'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",326.0,0.0669975,"DR (HR 1.539, 95% CI 1.332-1.842), eGFR (HR 0.943, 95% CI 0.919-0.961), and 24-h proteinuria (HR 1.211, 95% CI 1.132-1.387) were identified as risk factors for renal endpoints.","[{'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Qunzi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China, fanyingsh@126.com.""}, {'ForeName': 'Niansong', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Kidney & blood pressure research,['10.1159/000505919']
639,31910279,Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial.,"Importance


Dietary supplements marketed for male fertility commonly contain folic acid and zinc based on limited prior evidence for improving semen quality. However, no large-scale trial has examined the efficacy of this therapy for improving semen quality or live birth.
Objective


To determine the effect of daily folic acid and zinc supplementation on semen quality and live birth.
Design, Setting, and Participants


The Folic Acid and Zinc Supplementation Trial was a multicenter randomized clinical trial. Couples (n = 2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017. The last 6-month study visit for semen collection occurred during August 2018, with chart abstraction of live birth and pregnancy information completed during April 2019.
Interventions


Men were block randomized by study center and planned infertility treatment (in vitro fertilization, other treatment at a study site, and other treatment at an outside clinic) to receive either 5 mg of folic acid and 30 mg of elemental zinc (n = 1185) or placebo (n = 1185) daily for 6 months.
Main Outcomes and Measures


The co-primary outcomes were live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count) at 6 months after randomization.
Results


Among 2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit. Live birth outcomes were available for all couples, and 1629 men (69%) had semen available for analysis at 6 months after randomization. Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]). Most of the semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count) were not significantly different between treatment groups at 6 months after randomization. A statistically significant increase in DNA fragmentation was observed with folic acid and zinc supplementation (mean of 29.7% for percentage of DNA fragmentation in the folic acid and zinc group and 27.2% in the placebo group; mean difference, 2.4% [95% CI, 0.5% to 4.4%]). Gastrointestinal symptoms were more common with folic acid and zinc supplementation compared with placebo (abdominal discomfort or pain: 66 [6%] vs 40 [3%], respectively; nausea: 50 [4%] vs 24 [2%]; and vomiting: 32 [3%] vs 17 [1%]).
Conclusions and Relevance


Among a general population of couples seeking infertility treatment, the use of folic acid and zinc supplementation by male partners, compared with placebo, did not significantly improve semen quality or couples' live birth rates. These findings do not support the use of folic acid and zinc supplementation by male partners in the treatment of infertility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01857310.",2020,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","['Couples (n\u2009', 'Couples Undergoing Infertility Treatment', '2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit', '2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017']","['planned infertility treatment (in vitro fertilization', 'placebo', 'folic acid and zinc', 'daily folic acid and zinc supplementation', 'folic acid and zinc supplementation', 'folic acid and 30 mg of elemental zinc (n\u2009=\u20091185) or placebo', 'Folic Acid and Zinc Supplementation']","['Live birth', 'Live birth outcomes', 'vomiting', 'semen quality and live birth', 'DNA fragmentation', 'nausea', 'Gastrointestinal symptoms', 'live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count', 'Semen Quality and Live Birth', 'semen quality or live birth', 'semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count', ""semen quality or couples' live birth rates""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",2370.0,0.613709,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","[{'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Departments of Surgery (Urology) and Human Genetics, School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Van Voorhis', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hotaling', 'Affiliation': ""Center for Reconstructive Urology and Men's Health, Departments of Surgery (Urology) and Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",JAMA,['10.1001/jama.2019.18714']
640,32272079,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30257-7.,,2020,,[],[],[],[],[],[],,0.0200868,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30283-8']
641,32401941,Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial.,"Objective The aim of this study was to compare the effects of music at 432 Hz, 440 Hz, and no music on the clinical perception of anxiety and salivary cortisol levels in patients undergoing tooth extraction. Methodology A parallel-group randomized clinical trial was conducted. Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety were distributed in three groups: use of music for 15 minutes at a frequency of 432 Hz (n=15), at 440 Hz (n=15) and a control group without music (n=12). The CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA), were measured and compared before and after the music intervention between groups (two-way ANOVA-Tukey p<0.05, RStudio). Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05). The salivary cortisol level at 432 Hz (0.49±0.37 μg/dL) was significantly lower than 440 Hz (1.35±0.69 μg/dL) and the control group (1.59±0.7 μg/dL; p<0.05). Conclusion The use of music significantly decreased clinical anxiety levels, and the frequency of 432 Hz was effective in decreasing salivary cortisol levels before tooth extraction.",2020,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"['Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety', 'patients undergoing tooth extraction']","['control group without music', 'music at 432 Hz, 440 Hz, and no music', 'music at 432 Hz and 440 Hz']","['CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA', 'salivary cortisol level', 'clinical perception of anxiety and salivary cortisol levels', 'clinical anxiety levels', 'salivary cortisol levels', 'dental anxiety and salivary cortisol levels', 'anxiety level values']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4517777', 'cui_str': '440'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",42.0,0.112363,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"[{'ForeName': 'Pedro Christian', 'Initials': 'PC', 'LastName': 'Aravena', 'Affiliation': 'Instituto de Anatomía, Histología y Patología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Almonacid', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Marcelo Ignacio', 'Initials': 'MI', 'LastName': 'Mancilla', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0601']
642,32103160,Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.,"OBJECTIVE


To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.
STUDY DESIGN


Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).
RESULTS


Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.
CONCLUSION


A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.",2020,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","['preterm neonates that met study criteria (n\u2009=\u2009169', 'premature neonates', 'preterm neonates', 'preterm neonates experiencing a clinically required heel lance']","['Oral dextrose', 'oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2\u2009min before heel lance', '30% oral dextrose']","['premature infant pain profile-revised (PIPP-R', 'plasma markers of ATP utilization and oxidative stress', 'biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress', 'Pain', 'procedural pain', 'Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C3179031', 'cui_str': 'Facilitated Tucking'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}]",169.0,0.263784,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","[{'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA. dangeles@llu.edu.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'School of Public Health, Loma Linda Univeristy, Loma Linda, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'School of Nursing, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hopper', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Aprille', 'Initials': 'A', 'LastName': 'Febre', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pegis', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lavery', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Munaf', 'Initials': 'M', 'LastName': 'Kadri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Mousselli', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Vora', 'Initials': 'V', 'LastName': 'Farha', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Fayard', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0634-0']
643,31326995,Plaque burden can be assessed using intravascular optical coherence tomography and a dedicated automated processing algorithm: a comparison study with intravascular ultrasound.,"AIMS


Plaque burden (PB) measurement using intravascular optical coherence tomography (IVOCT) is currently thought to be inferior to intravascular ultrasound (IVUS). We developed an automated IVOCT image processing algorithm to enhance the external elastic lamina (EEL) contour. Thus, we investigated the accuracies of standard IVOCT and an IVOCT enhancement algorithm for measuring PB using IVUS as the reference standard.
METHODS AND RESULTS


The EEL-enhancement algorithm combined adaptive attenuation compensation, exponentiation, angular registration, and image averaging using three sequential frames. In two different laboratories with intravascular imaging expertise, PB was quantified on 200 randomized, matched IVOCT and IVUS images by four independent observers. Fibroatheroma, fibrocalcific plaque, fibrous plaque, pathological intimal thickening (PIT), and mixed plaque were included in each set. Pearson's correlation coefficients between IVUS and standard IVOCT measurements of PB were 0.61, 0.67, 0.76, 0.78, and 0.87 for fibroatheromas, mixed plaques, fibrocalcific plaques, fibrous plaques, and PIT plaques, respectively. Pearson's correlation coefficients increased to 0.81, 0.83, 0.83, 0.84, and 0.90 when using the EEL-enhanced images (P = 0.003, P = 0.004, P = 0.08, P = 0.12, and P = 0.23, respectively). EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively). Compared with standard IVOCT, the EEL-enhanced IVOCT images had a higher sensitivity (79% vs. 28%, P < 0.001) and specificity (98% vs. 85%, P = 0.03) for plaques with an IVUS PB ≥70%.
CONCLUSION


EEL-enhanced IVOCT can be used to reliably measure PB in all types of coronary atherosclerotic lesions, including fibroatheromas and mixed plaques.",2020,"EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively).",[],"['EEL-enhanced IVOCT', 'intravascular optical coherence tomography (IVOCT']","['mixed plaques, fibrocalcific plaques, fibrous plaques, and PIT plaques', 'IVUS and standard IVOCT measurements of PB', 'higher sensitivity', 'Fibroatheroma, fibrocalcific plaque, fibrous plaque, pathological intimal thickening (PIT), and mixed plaque', 'specificity']",[],"[{'cui': 'C0013671', 'cui_str': 'Anguilliformes'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0334146', 'cui_str': 'Fibrous plaque (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C3495932', 'cui_str': 'Intimal thickening'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",200.0,0.0522334,"EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively).","[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Gerbaud', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Luu', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Hany Ahmed Salaheldin Hussein', 'Initials': 'HASH', 'LastName': 'Osman', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Baldwin', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Coste', 'Affiliation': 'Cardiology Intensive Care Unit and Interventional Cardiology, Hôpital Cardiologique du Haut Lévêque, 5 Avenue Magellan, Pessac 33600, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cognet', 'Affiliation': ""Institut d'Optique Graduate School, CNRS-UMR 5298, Bordeaux University, Rue François Miterrand, Talence 33400, France.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Waxman', 'Affiliation': 'Department of Cardiology, Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Moses', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Guillermo J', 'Initials': 'GJ', 'LastName': 'Tearney', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez185']
644,30906944,"A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.","BACKGROUND


Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients.
METHODS


A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 weeks post-discharge. Secondary outcomes were changes in body composition, activities of daily living, and 30-day readmissions. Comparisons were made across study groups and between placebo and all active intervention groups.
RESULTS


Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. Readmission rates were highest in placebo (28%), followed by rehabilitation + placebo (15%), whey protein (12%), rehabilitation + whey protein (11%), and testosterone (5%). There was a trend for lower readmission rates in all active intervention groups (11%) versus placebo group (28%).
CONCLUSIONS


Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. These data provide essential information to design larger randomized controlled trials to test the effectiveness of these interventions.",2019,"Four weeks post-discharge the SPPB total score, and balance score increased more in AIG than placebo (P<0.05).","['Geriatric Patients', '100 patients admitted to the UTMB hospital for an acute medical illness', 'geriatric patients', 'older adults following acute hospitalization']","['isocaloric placebo, whey protein supplement, in-home rehabilitation+placebo, rehabilitation+whey protein, or testosterone', 'placebo', 'protein supplementation, exercise, and testosterone interventions']","['Functional Recovery', 'changes in body composition, activities of daily living, and 30-day readmissions', 'change from baseline in Short Physical Performance Battery (SPPB) score', 'Readmission rates', 'body composition or activities of daily living', 'SPPB total score, and balance score', 'lower readmission rates']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",100.0,0.43346,"Four weeks post-discharge the SPPB total score, and balance score increased more in AIG than placebo (P<0.05).","[{'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Baillargeon', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Fisher', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Mukaila', 'Initials': 'M', 'LastName': 'Raji', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz084']
645,32404132,Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.,"BACKGROUND


Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidences suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation plays an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate the effectiveness of robotic-based intervention of the older adults with Parkinson's disease, designed to improve the gait and to reduce the risk of falling.
METHODS


This study is a single-blinded randomized controlled trial. The primary outcomes are: risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively. One hundred ninety-five patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10-treatment session will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system.
DISCUSSION


The final goals of the present study are to propose a new approach in the PD rehabilitation, focused on the use of robotic device, and to check the results not only at the end of the treatment but also in the long term.
TRIAL REGISTRATION


NCT04087031, registration date September 12, 2019.",2020,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"['One hundred ninety-five patients with PD', ""older people with Parkinson's disease"", ""older adults with Parkinson's disease""]","['traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy', 'robotic-based intervention']","['risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]",,0.0298868,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy. r.bevilacqua@inrca.it.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pelliccioni', 'Affiliation': 'Neurology Unit, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}]",BMC neurology,['10.1186/s12883-020-01759-4']
646,32197884,A training program to prepare exercise coaches for delivery of the HEART camp intervention to patients with heart failure.,,2020,,['patients with heart failure'],['HEART camp intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]",[],,0.0113118,,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Duncan', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America. Electronic address: kduncan@unmc.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'McGuire', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151226']
647,32197956,"Randomized Trial on the Effects of High-Dose Zopiclone on OSA Severity, Upper Airway Physiology, and Alertness.","BACKGROUND


Studies indicate that standard doses of hypnotics reduce or do not change the apnea-hypopnea index (AHI) or pharyngeal muscle activity. A 1-month trial of nightly zopiclone (7.5 mg) modestly reduced the AHI vs baseline without changing other sleep parameters or next-day sleepiness.
RESEARCH QUESTION


This study aimed to determine the effects of high-dose zopiclone (15 mg) on AHI, arousal threshold, genioglossus muscle responsiveness, and next-day alertness in selected people with OSA (low to moderate arousal thresholds without major overnight hypoxemia). We hypothesized that high-dose zopiclone would yield greater increases in arousal threshold and therefore larger reductions in AHI but may come at the expense of increased hypoxemia and next-day impairment.
STUDY DESIGN AND METHODS


Twenty-eight participants (AHI = 29 ± 20 events/h) suspected to have low to moderate arousal thresholds were studied during two in-laboratory polysomnographies, separated by 1 week, with an epiglottic pressure catheter and genioglossus intramuscular electrodes. Participants received 15 mg of zopiclone or placebo at each visit according to a double-blind, randomized, crossover design. Each morning, subjective sleepiness and alertness via a driving simulator task were assessed.
RESULTS


The AHI did not change from placebo to zopiclone (-1.5 events/h; 95% CI, -6.6 to 3.5 events/h; P = .54). Arousal threshold, genioglossus muscle responsiveness, and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
INTERPRETATION


A single night of treatment with high-dose zopiclone does not systematically reduce the AHI or increase the arousal threshold in selected people with OSA. The mechanisms for these unexpected findings require further investigation.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000988358; URL: https://www.anzctr.org.au.",2020,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","['selected people with obstructive sleep apnea (OSA) (low-moderate arousal thresholds without major overnight hypoxemia', 'and methods: 28 participants (AHI=29±20events/h) suspected to have low-moderate arousal thresholds']","['high-dose zopiclone', 'zopiclone or placebo', 'epiglottic pressure catheter and genioglossus intramuscular electrodes', 'nightly zopiclone']","['AHI, arousal threshold, genioglossus muscle responsiveness and next-day alertness', 'Arousal threshold, genioglossus muscle responsiveness', 'subjective sleepiness and alertness via a driving simulator task', 'OSA severity, upper airway physiology and alertness', 'apnea-hypopnea index (AHI) or pharyngeal muscle activity', 'sleep parameters and measures of next-day sleepiness and alertness']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0031346', 'cui_str': 'Muscles of Pharynx'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.288769,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","[{'ForeName': 'Sophie G', 'Initials': 'SG', 'LastName': 'Carter', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW. Electronic address: s.carter@neura.edu.au.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}]",Chest,['10.1016/j.chest.2020.02.057']
648,32195857,The Wrist and Radius Injury Surgical Trial: 12-Month Outcomes from a Multicenter International Randomized Clinical Trial.,"BACKGROUND


Optimal treatment for distal radius fractures in older adults remains uncertain. No randomized trials comparing the most frequently used treatments in this population have been conducted. Surgical treatment rates vary widely, and the sustained benefits of surgery are uncertain.
METHODS


The Wrist and Radius Injury Surgical Trial, a randomized, multicenter trial, enrolled 304 adults aged 60 years and older with isolated, unstable distal radius fractures at 24 institutions. Patients who wanted surgery (n = 187) were randomized to internal fixation, external fixation, or percutaneous pinning; patients who preferred conservative management (n = 117) received casting. The primary outcome was the 12-month Michigan Hand Outcomes Questionnaire (MHQ) summary score.
RESULTS


At 12 months, there were no differences by treatment in primary outcome. Twelve-month MHQ summary scores differed between internal fixation and external fixation by 3 points (97.5 percent CI, 6.0 to 11.5) and between internal fixation and pinning by -0.14 (97.5 percent CI, -9.2 to 8.9). However, at 6 weeks, the mean MHQ summary score for internal fixation was greater than for external fixation by 19 (p < 0.001), pinning by 11 (p < 0.001), and casting by 7 (p = 0.03). Internal fixation participants demonstrated significantly better radiologic alignment throughout the follow-up period. Malunion was experienced by 48 percent of casting participants.
CONCLUSIONS


Recovery was fastest for internal fixation and slowest for external fixation according to most measures, but by 12 months there were no meaningful differences in outcomes. Casting participants experienced satisfactory results despite loss of radiologic alignment.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"Twelve-month MHQ Summary scores differed between VLPS and EFP by 3 points (97.5% CL: -6.0, 11.5) and between VLPS and pinning by -0.14(-9.2,8.9).","['distal radius fractures (DRFs) in older adults', 'Patients who wanted surgery (n=187', 'enrolled 304 adults age 60 years and older with isolated, unstable DRFs at 24 institutions']","['VLPS', 'internal fixation with volar plate (VLPS), external fixation (EFP), or percutaneous pinning; patients who preferred conservative management (n=117) received casting']","['12-month Michigan Hand Outcomes Questionnaire (MHQ) Summary score', 'radiologic alignment', 'mean MHQ Summary score for VLPS', 'MHQ domain scores and radiographic parameters']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",304.0,0.137787,"Twelve-month MHQ Summary scores differed between VLPS and EFP by 3 points (97.5% CL: -6.0, 11.5) and between VLPS and pinning by -0.14(-9.2,8.9).","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'Ann Arbor, Mich. From the Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School; and the Center for Statistical Consulting and Research, University of Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sunitha', 'Initials': 'S', 'LastName': 'Malay', 'Affiliation': ''}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006829']
649,32195858,"The Effect of Surgical Video on Resident Performance of Carpal Tunnel Release: A Cadaveric Simulation-Based, Prospective, Randomized, Blinded Pilot Study.","BACKGROUND


Surgical videos are increasingly common, although their role in residency curricula remains unclear. The aim of this study was to evaluate the impact of an educational surgical video on resident performance of an open carpal tunnel release through an Objective Structured Assessment of Technical Skills and serial questionnaires.
METHODS


Twenty-two residents representing six postgraduate years were randomized to receive text-based materials with or without a surgical video before performing a carpal tunnel release on human cadavers. Procedures were video recorded, anonymized, and independently evaluated by three hand surgeons using the Objective Structured Assessment of Technical Skills global rating scale, a procedure-specific technical rating scale, a record of operative errors, and pass/fail designation. Residents completed questionnaires before and after the procedure to track confidence in their technical skills.
RESULTS


Residents in their first and second postgraduate years (n = 10) who watched the surgical video committed fewer operative errors (median, 4 versus 1.3; p = 0.043) and were more confident in their abilities following the procedure (median, 75 versus 32; p = 0.043) than those receiving text resources alone. There were no significant differences in Objective Structured Assessment of Technical Skills performance or questionnaire responses among more senior residents (n = 12). The technical rating scale was internally consistent (Cronbach α = 0.95; 95 percent CI, 0.91 to 0.98), reliable (intraclass correlation coefficient, 0.73; 95 percent CI, 0.40 to 0.88), and correlated with surgical experience (Spearman ρ = 0.57; p = 0.006).
CONCLUSION


Watching an educational surgical video to prepare for a cadaveric procedure significantly reduced operative errors and improved confidence among junior trainees performing a carpal tunnel release.",2020,Watching an educational surgical video to prepare for a cadaveric procedure significantly reduced operative errors and improved confidence among junior trainees performing a carpal tunnel release.,"['Twenty-two residents representing six postgraduate years', 'Carpal Tunnel Release']","['educational surgical video', 'text-based materials with or without a surgical video before performing a carpal tunnel release on human cadavers', 'Surgical Video']","['OSATS global rating scale, a procedure-specific technical rating scale, a record of operative errors, and pass/fail designation', 'technical rating scale', 'operative errors', 'OSATS performance or questionnaire responses']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0372309,Watching an educational surgical video to prepare for a cadaveric procedure significantly reduced operative errors and improved confidence among junior trainees performing a carpal tunnel release.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'St. Louis, Mo.; and Utrecht, The Netherlands From the Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine; and the Department of Plastic, Reconstructive and Hand Surgery, Utrecht University Medical Center.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Padovano', 'Affiliation': ''}, {'ForeName': 'Amanda G', 'Initials': 'AG', 'LastName': 'Rowe', 'Affiliation': ''}, {'ForeName': 'Elspeth J R', 'Initials': 'EJR', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'J Henk', 'Initials': 'JH', 'LastName': 'Coert', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Mackinnon', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006817']
650,32195861,Postoperative Antibiotic Prophylaxis in Reduction Mammaplasty: A Randomized Controlled Trial.,"BACKGROUND


Reduction mammaplasty is a well-established procedure. Studies have shown benefits of using antibiotics in this procedure. Nevertheless, there is no solid evidence to support postoperative antibiotic prophylaxis. The authors evaluated the influence of postoperative antibiotic delivery on infection rates after reduction mammaplasty.
METHODS


The authors conducted a randomized trial of noninferiority, with two parallel groups, with triple blinding. The participants were 124 women with breast hypertrophy, with reduction mammaplasty already scheduled, selected consecutively. All patients underwent reduction mammaplasty, performed by the same surgical team, using the superomedial pedicle technique for ascending the nipple-areola complex. All patients received cephalothin (1 g) intravenously at the anesthetic induction and every 6 hours for 24 hours. At hospital discharge, they were assigned randomly to either the placebo (n = 62) or antibiotic group (n = 62) and were instructed to take identical capsules containing 500 mg of cephalexin or placebo, respectively, every 6 hours, for 7 days. Patients were assessed weekly, for 4 weeks, regarding the occurrence of surgical-site infection, by a surgeon who was unaware of the allocation. The criteria and definitions of the Centers for Disease Control and Prevention were adopted.
RESULTS


There was no statistical difference between groups regarding age, body mass index, or resected breast tissue weight. The overall surgical-site infection rate was 0.81 percent. Only one patient, allocated to the antibiotic, presented infection, classified as superficial incisional (p = 1.00). In the placebo group, surgery time was higher (p = 0.003).
CONCLUSION


The maintenance of antibiotics in the postoperative period of reduction mammaplasty did not influence the rates of surgical-site infection.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, I.",2020,"Only one patient, allocated to AG, presented infection, classified as superficial incisional (p=1.00).","['124 women with breast hypertrophy, with reduction mammaplasty already scheduled, selected consecutively', 'reduction mammaplasty']","['Postoperative antibiotic prophylaxis', 'placebo', 'antibiotic', 'cephalothin', 'cephalexin or placebo']","['infection rates', 'surgery time', 'overall surgical site infection rate', 'rates of surgical site infection']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0007735', 'cui_str': 'cefalotin'}, {'cui': 'C0007716', 'cui_str': 'Cephalexin'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}]",124.0,0.159188,"Only one patient, allocated to AG, presented infection, classified as superficial incisional (p=1.00).","[{'ForeName': 'Edgard S', 'Initials': 'ES', 'LastName': 'Garcia', 'Affiliation': 'São Paulo and Pouso Alegre, Brazil From the Graduate Program in Translational Surgery, Universidade Federal de São Paulo; the Division of Plastic Surgery and the Department of Bioestatistics, Universidade do Vale do Sapucaí; and Universidade de Santo.'}, {'ForeName': 'Daniela F', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Veiga-Filho', 'Affiliation': ''}, {'ForeName': 'Isaías V', 'Initials': 'IV', 'LastName': 'Cabral', 'Affiliation': ''}, {'ForeName': 'Natália L L', 'Initials': 'NLL', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Novo', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sabino-Neto', 'Affiliation': ''}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006809']
651,31094772,Impact of 2 Distinct Levels of Mean Arterial Pressure on Near-Infrared Spectroscopy During Cardiac Surgery: Secondary Outcome From a Randomized Clinical Trial.,"BACKGROUND


Near-infrared spectroscopy (NIRS) is used worldwide to monitor regional cerebral oxygenation (rScO2) during cardiopulmonary bypass (CPB). Intervention protocols meant to mitigate cerebral desaturation advocate to increase mean arterial pressure (MAP) when cerebral desaturation occurs. However, the isolated effect of MAP on rScO2 is uncertain. The aim of the present study was in a randomized, blinded design to elucidate the effect of 2 distinct levels of MAP on rScO2 values during CPB.We hypothesized that a higher MAP would be reflected in higher rScO2 values, lower frequency of patients with desaturation, and a less pronounced cerebral desaturation load.
METHODS


This is a substudy of the Perfusion Pressure Cerebral Infarct trial, in which we investigated the impact of MAP levels during CPB on ischemic brain injury after cardiac surgery. Deviation in rScO2 was a predefined outcome in the Perfusion Pressure Cerebral Infarct trial. Patients were randomized to low MAP (LMAP; 40-50 mm Hg) or high MAP (HMAP; 70-80 mm Hg) during CPB. CPB pump flow was fixed at 2.4 L/min/m, and MAP levels were targeted using norepinephrine. Intraoperatively, NIRS monitoring was performed in a blinded fashion, with sensors placed on the left and right side of the patient's forehead. NIRS recordings were extracted for offline analysis as the mean value of left and right signal during prespecified periods. Mean rScO2 during CPB was defined as the primary outcome in the present study.
RESULTS


The average MAP level during CPB was 67 mm Hg ± SD 5.0 in the HMAP group (n = 88) and 45 mm Hg ± SD 4.4 in the LMAP group (n = 88). Mean rScO2 was significantly lower in the HMAP group during CPB (mean difference, 3.5; 95% confidence interval, 0.9-6.1; P = .010). There was no difference in rScO2 values at specified time points during the intraoperative period between the 2 groups. Significantly more patients experienced desaturation below 10% and 20% relative to rScO2 baseline in the HMAP group (P = .013 and P = .009, respectively), and the cerebral desaturation load below 10% relative to rScO2 baseline was more pronounced in the HMAP group (P = .042).
CONCLUSIONS


In a randomized blinded study, we observed that a higher MAP induced by vasopressors, with a fixed CPB pump flow, leads to lower mean rScO2 and more frequent and pronounced cerebral desaturation during CPB. The mechanism behind these observations is not clear. We cannot exclude extracranial contamination of the NIRS signal as a possible explanation. However, we cannot recommend increasing MAP by vasoconstrictors during cerebral desaturation because this is not supported by the findings of the present study.",2019,"Significantly more patients experienced desaturation below 10% and 20% relative to rScO2 baseline in the HMAP group (P = .013 and P = .009, respectively), and the cerebral desaturation load below 10% relative to rScO2 baseline was more pronounced in the HMAP group (P = .042).
",['ischemic brain injury after cardiac surgery'],"['Near-infrared spectroscopy (NIRS', 'LMAP', 'low MAP (LMAP; 40-50 mm Hg) or high MAP (HMAP', 'Cardiac Surgery', 'HMAP']","['average MAP level', 'mean arterial pressure (MAP', 'CPB pump flow', 'cerebral desaturation load', 'Mean rScO2', 'rScO2 values', 'Mean Arterial Pressure']","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0450400', 'cui_str': '50mm (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.292205,"Significantly more patients experienced desaturation below 10% and 20% relative to rScO2 baseline in the HMAP group (P = .013 and P = .009, respectively), and the cerebral desaturation load below 10% relative to rScO2 baseline was more pronounced in the HMAP group (P = .042).
","[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Holmgaard', 'Affiliation': 'From the Department of Cardiothoracic Anesthesiology, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Vedel', 'Affiliation': 'From the Department of Cardiothoracic Anesthesiology, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'From the Department of Cardiothoracic Anesthesiology, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne B', 'Initials': 'HB', 'LastName': 'Ravn', 'Affiliation': 'From the Department of Cardiothoracic Anesthesiology, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003418']
652,32055002,Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.
METHODS


We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.
RESULTS


No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29-2.80]; p = 0.001) and high-volume (HR 2.75 [1.84-4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p < 0.0001).
CONCLUSIONS


In new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.",2020,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","['patients with new metastatic hormone-sensitive prostate cancer', '210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm', 'new metastatic hormone-sensitive prostate cancer']",['cixutumumab'],"['Inferior survival', 'radiographic progression-free survival', 'inferior survival', 'Survival outcomes', 'overall survival, radiographic progression-free survival, and castration resistance-free survival', 'castration resistance-free survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C2699335'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[{'cui': 'C2699335'}],"[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]",210.0,0.28146,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","[{'ForeName': 'Risa L', 'Initials': 'RL', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mai T', 'Initials': 'MT', 'LastName': 'Duong', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA. evanyu@uw.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0210-x']
653,31756547,Preoperative chemotherapy compared with postoperative adjuvant chemotherapy for squamous cell carcinoma of the thoracic oesophagus with the detection of circulating tumour cells randomized controlled trial.,"BACKGROUND


The role of preoperative chemotherapy in the treatment of patients with oesophageal squamous cell carcinoma (ESCC) remains controversial. Chemotherapy followed by surgery was compared with surgery ± chemotherapy, and the detection of circulating tumour cells (CTCs) was performed on all enrolled patients.
METHODS


We randomly assigned patients with resectable tumours to the preoperative chemotherapy group (Pre group) or surgery group (patients who were either given or not given adjuvant chemotherapy according to their postoperative lymph node status, Post group). Blood samples were collected 1-3 days before treatment (including preoperative chemotherapy and surgery) and 7 days after surgery for CTC detection.
RESULTS


From July 2016 to October 2018, 115 patients were enrolled in the study, of whom 57 were assigned to the Pre group and 58 to the Post group. The proportion of patients with stage III ESCC was 63.16% in the Pre group and 48.28% in the Post group. No patients died during chemotherapy. One patient exhibited a complete response to preoperative chemotherapy, and 13 patients exhibited partial responses. The 2-year progression-free survival (PFS) and overall survival (OS) rates were not significantly different between the Pre and Post groups. In the subgroup analysis, patients with CTC (+) prior to treatments receiving preoperative chemotherapy had a better 2-year PFS (71.90% vs. 38.73%, P = 0.0379). In the Cox proportional hazards regression analysis, platelet count was proven to correlate significantly with disease progression (P = 0.016), and no factors were proven to correlate significantly with mortality after the factors were balanced in the present analysis.
CONCLUSIONS


Preoperative chemotherapy improved the short-term PFS when CTC detection was positive prior to any treatment for patients with stage II or III ESCC. CTC detection may be used as an index to guide individualized strategic decisions regarding preoperative chemotherapy, but more evidence is needed.",2020,The 2-year progression-free survival (PFS) and overall survival (OS) rates were not significantly different between the Pre and Post groups.,"['patients with oesophageal squamous cell carcinoma (ESCC', 'From July 2016 to October 2018, 115 patients were enrolled in the study, of whom 57 were assigned to the Pre group and 58 to the Post group', 'patients with stage II or III ESCC', 'squamous cell carcinoma of the thoracic oesophagus', 'We randomly assigned patients with resectable tumours to the']","['Preoperative chemotherapy', 'postoperative adjuvant chemotherapy', 'preoperative chemotherapy', 'preoperative chemotherapy group (Pre group) or surgery group (patients who were either given or not given adjuvant chemotherapy', 'Chemotherapy']","['proportion of patients with stage III ESCC', 'partial responses', 'Blood samples', '2-year progression-free survival (PFS) and overall survival (OS) rates', '2-year PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0227188', 'cui_str': 'Thoracic esophagus structure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",115.0,0.0526815,The 2-year progression-free survival (PFS) and overall survival (OS) rates were not significantly different between the Pre and Post groups.,"[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Shandong Cancer Hospital and Institute (HL), Jinan, Shandong, China.'}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic Surgery, Shandong Cancer Hospital and Institute (HL), Jinan, Shandong, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zhaoxiaogang@sdu.edu.cn.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2019.11.005']
654,32272022,Circulating MicroRNAs and Treatment Response in Childhood Asthma.,"RATIONALE


Inhaled corticosteroids (ICS) are key treatments for controlling asthma and preventing asthma attacks. However, the responsiveness to ICS varies among individuals. MiRNAs have been lauded for their prognostic utility.
OBJECTIVES


We hypothesized that circulating miRNAs obtained at baseline/pre-randomization in the Childhood Asthma Management Program (CAMP) could serve as biomarkers and biologic mediators of ICS clinical response over the 4-year clinical trial period.
METHODS


We selected baseline serum samples from 462 CAMP subjects subsequently randomized to either ICS (budesonide) or placebo. Samples underwent small RNA sequencing and read counts were normalized and filtered by depth and coverage. Linear regression was used to associate miRNAs with change in FEV1% (pre-bronchodilator FEV1 as a percent of predicted) over the 4-year CAMP period in both main effects and interaction models. We validated the function of the top associated miRNAs by luciferase reporter assays of glucocorticoid mediated transrepression and predicted response to ICS through logistic regression models.
MEASUREMENTS AND MAIN RESULTS


We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments. We selected three miRNAs for functional validation, of which hsa-miR-155-5p and hsa-miR-532-5p were significantly associated with changes in dexamethasone-induced transrepression of NF-κB. Combined, these two miRNAs were predictive of ICS response over the course of the clinical trial, with the area under receiver operating characteristic curve (AUROC) of 0.86.
CONCLUSIONS


We identified two functional circulating miRNAs predictive of asthma ICS treatment response over time.",2020,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"['Childhood Asthma', '462 CAMP subjects subsequently randomized to either']","['corticosteroids (ICS', 'placebo', 'ICS (budesonide) or placebo']",['ICS response'],"[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",462.0,0.187332,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Brigham and Women's Hospital Channing Division of Network Medicine, 1869, Medicine, Boston, Massachusetts, United States.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Panganiban', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Program in Molecular and Integrative Physiological Sciences, Boston, Massachusetts, United States.'}, {'ForeName': 'Alvin T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ""Boston Children's Hospital, 1862, Informatics Program, Harvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, United States.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': ""Brigham and Women's Hospital, 1861, Channing Division of Network Medicine, Boston, Massachusetts, United States.""}, {'ForeName': 'Leanna', 'Initials': 'L', 'LastName': 'Farnam', 'Affiliation': ""Brigham and Women's Hospital Channing Division of Network Medicine, 1869, Boston, Massachusetts, United States.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': ""Brigham and Women's Hospital Channing Division of Network Medicine, 1869, Boston, Massachusetts, United States.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Brigham and Women's Hospital Channing Division of Network Medicine, 1869, Boston, Massachusetts, United States.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Program in Molecular and Integrative Physiological Sciences, Boston, Massachusetts, United States.'}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': ""Brigham and Women's Hospital, 1861, Medicine, Boston, Massachusetts, United States; rekgt@channing.harvard.edu.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1454OC']
655,32404035,Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups.,"Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction  P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction  P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2020,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","['patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with', 'older patients', 'patients with embolic stroke of undetermined source', 'Patients With Embolic Stroke of Undetermined Source', '5390 patients from December 2014 to January 2018']","['Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'aspirin 100 mg once daily', 'Methods- RE-SPECT ESUS', 'Aspirin', ' and Purpose', 'dabigatran versus aspirin', 'aspirin', 'Conclusions', 'dabigatran']","['Stroke rates', 'Risks for major bleeding', 'recurrent stroke', 'rates of recurrent stroke and major bleeding', 'rate of recurrent stroke', 'bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",5390.0,0.375563,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brainin', 'Affiliation': 'Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gdovinová', 'Affiliation': 'Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Martins', 'Affiliation': 'Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).'}, {'ForeName': 'Truman', 'Initials': 'T', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Rose', 'Affiliation': 'Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Šaňák', 'Affiliation': 'Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).'}, {'ForeName': 'Wolf-Rüdiger', 'Initials': 'WR', 'LastName': 'Schäbitz', 'Affiliation': 'Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).'}]",Stroke,['10.1161/STROKEAHA.119.028643']
656,32404430,Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.,"OBJECTIVES


To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.
DESIGN


Open, multicentre, randomised, controlled, non-inferiority trial.
SETTING


Seven National Health Service tertiary hospitals in the United Kingdom.
PARTICIPANTS


1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.
INTERVENTION


Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.
OUTCOME MEASURES


The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.
RESULTS


Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.
CONCLUSIONS


For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.
TRIAL REGISTRATION


ISRCTN13911492.",2020,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","['1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate', 'patients who have elective surgery and are at moderate or high risk of venous thromboembolism', 'patients undergoing elective surgery', 'Seven National Health Service tertiary hospitals in the United Kingdom', '1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery', 'elective surgical patients (GAPS study', 'Between May 2016 and January 2019, 1905 participants were randomised']","['low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS', 'LMWH', 'Graduated compression stockings', 'graduated compression stockings (GCS', 'GCS']","['imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms', 'quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1905.0,0.261781,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dhillon', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Everington', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Hampshire, UK.'}, {'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Zaed', 'Initials': 'Z', 'LastName': 'Hamady', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gerrard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK a.h.davies@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m1309']
657,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND


We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS


We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend  = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend  = 0.03); the association was primarily present for distal CRC (P- trend  = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction  < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend  = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION


Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
658,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE


LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery.
MATERIALS AND METHODS


Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit.
RESULTS


In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum.
CONCLUSION


Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y']
659,32406112,Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.,"BACKGROUND


Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS-C) symptoms, but how it improves pain in humans is unknown.
AIMS


To investigate the effects of linaclotide and placebo on the afferent and efferent gut-brain-gut signalling in IBS-C patients, in a randomised clinical trial.
METHODS


Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations. Rectal sensations were examined by balloon distention. Assessments included abdominal pain, bowel symptoms and quality of life (QOL) scores. Primary outcomes were latencies of recto-cortical and cortico-rectal evoked potentials.
RESULTS


Thirty-nine patients participated; 26 received linaclotide and 13 received placebo. Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups. The efferent cortico-anorectal and spino-anorectal latencies were unchanged. The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03). Abdominal pain decreased (P < 0.001) with linaclotide but not between groups. Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo. There was no difference in overall responders between linaclotide and placebo (54% vs 23%, P = 0.13).
CONCLUSIONS


Linaclotide prolongs afferent gut-brain signalling from baseline but both afferent and efferent signalling were unaffected compared to placebo. Linaclotide significantly improves rectal hypersensitivity, IBS-C symptoms and QOL compared to placebo. These mechanisms may explain the effects of linaclotide on pain relief in IBS-C patients. ClinicalTrials.Gov: Registered at Clinical trials.gov no NCT02078323.",2020,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","['Thirty-nine patients participated; 26 received', 'IBS-C patients', 'Patients with IBS-C (Rome III) and rectal hypersensitivity']","['linaclotide', 'linaclotide (290\xa0µg) or placebo for 10\xa0weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations', 'Linaclotide', 'linaclotide vs placebo', 'linaclotide and placebo', 'placebo']","['abdominal pain, bowel symptoms and quality of life (QOL) scores', 'pain relief', 'overall responders', 'rectal hypersensitivity, IBS-C symptoms and QOL', 'Rectal sensations', 'latencies of recto-cortical and cortico-rectal evoked potentials', 'IBS-QOL scores', 'efferent cortico-anorectal and spino-anorectal latencies', 'Abdominal pain', 'Rectal cortical evoked potentials latencies (milliseconds', 'Complete spontaneous bowel movement frequency', 'maximum tolerable rectal volume (cc']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",39.0,0.636366,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Kulthep', 'Initials': 'K', 'LastName': 'Rattanakovit', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Ayyala', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15772']
660,32046418,An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis.,"Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.",2020,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","['women aged 14 to 49\xa0years', 'Bacterial Vaginosis', 'women with BV', 'adult women']","['placebo', 'secnidazole 2', 'Single-Dose Secnidazole', 'secnidazole']","['Bacterial vaginosis (BV', 'achievement of Nugent scores', 'clinical outcome responder rate', 'efficacy and safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074246', 'cui_str': 'secnidazole'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.140457,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pentikis', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA. helenpentikis@lupin.com.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Adetoro', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Tipping', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-019-00048-x']
661,32194058,"Outcomes of Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in the Early Treatment of Sepsis: The ORANGES Trial.","BACKGROUND


Sepsis is a major public health burden resulting in 25% to 30% in-hospital mortality and accounting for over 20 billion dollars of US hospital costs.
RESEARCH QUESTION


Does hydrocortisone, ascorbic acid, thiamine (HAT) therapy improve clinical outcomes in sepsis and septic shock?
STUDY DESIGN AND METHODS


This was a randomized, double-blinded, placebo-controlled trial conducted from February 2018 to June 2019, assessing an HAT treatment bundle for the management of septic and septic shock patients admitted to an ICU. The primary outcomes were resolution of shock and change in Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes included 28-day mortality, ICU mortality, hospital mortality, procalcitonin clearance (PCT-c), hospital length of stay (LOS), ICU LOS, and ventilator-free days.
RESULTS


One hundred thirty-seven patients were randomized to the treatment group (n = 68) and comparator group (n = 69), respectively, with no significant differences in baseline characteristics. A statistically significant difference was found in the time patients required vasopressors, indicating quicker reversal of shock in the HAT group compared with the comparator group (27 ± 22 vs 53 ± 38 hours, P < .001). No statistically significant change in SOFA score was found between groups 3 (1 - 6) vs 2 (0 - 4), P = .17. No significant differences were found between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
INTERPRETATION


Our results suggest that the combination of IV ascorbic acid, thiamine, and hydrocortisone significantly reduced the time to resolution of shock. Additional studies are needed to confirm these findings and assess any potential mortality benefit from this treatment.
TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT03422159; URL: www.clinicaltrials.gov.",2020,"There were no significant differences between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
","['February 2018 to June 2019 assessing an', 'septic and septic shock patients admitted to an intensive care unit (ICU', 'Sepsis', '137 patients']","['intravenous ascorbic acid, thiamine, and hydrocortisone', 'Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids', 'ascorbic acid (AA), thiamine, and hydrocortisone (HAT) treatment bundle', 'placebo']","['resolution of shock and change in Sequential Organ Failure Assessment (SOFA) score', '28-day mortality, ICU mortality, hospital mortality, procalcitonin clearance (PCT-c), hospital length of stay (LOS), ICU LOS, and ventilator free days', 'ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c', 'SOFA score', 'time patients required vasopressors indicating quicker reversal of shock', 'time to resolution of shock']","[{'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",137.0,0.509907,"There were no significant differences between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Iglesias', 'Affiliation': 'Department of Critical Care, Department of Nephrology, Community Medical Center, Toms River, NJ; Department of Nephrology, Jersey Shore University Medical Center, Hackensack Meridian School of Medicine at Seton Hall, Neptune, NJ. Electronic address: jiglesias23@gmail.com.'}, {'ForeName': 'Andrew V', 'Initials': 'AV', 'LastName': 'Vassallo', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Vishal V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Jesse B', 'Initials': 'JB', 'LastName': 'Sullivan', 'Affiliation': 'Fairleigh Dickinson University School of Pharmacy & Health Sciences, Teaneck, NJ.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Elbaga', 'Affiliation': 'Department of Pharmacy, Monmouth Medical Center Southern Campus, Lakewood, NJ.'}]",Chest,['10.1016/j.chest.2020.02.049']
662,32194098,Effects of a lifestyle intervention on cardiovascular risk among high-risk individuals for diabetes in a low- and middle-income setting: Secondary analysis of the Kerala Diabetes Prevention Program.,"We aimed to examine whether a lifestyle intervention was effective in reducing cardiovascular disease (CVD) risk in individuals at high-risk of developing diabetes in a low- and middle-income setting. The Kerala Diabetes Prevention Program was evaluated by a cluster-randomized controlled trial (2013-2016) of 1007 individuals (aged 30-60 years) at high-risk for diabetes (Indian Diabetes Risk Score ≥ 60 and without diabetes) in Kerala state, India. Sixty polling areas in Kerala were randomized to intervention or control groups by an independent statistician using a computer-generated randomization sequence. Participants from 30 intervention communities received a 12-month structured peer-support lifestyle intervention program involving 15 group sessions and linked community activities, aimed at supporting and maintaining lifestyle change. The primary outcome for this analysis was the predicted 10-year CVD risk at two years, assessed using the Framingham Risk Score. The mean age at baseline was 46.0 (SD: 7.5) years, and 47.2% were women. Baseline 10-year CVD risk was similar between study groups. The follow-up rate at two years was 95.7%. The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years. The favorable change in CVD risk with the intervention condition was mainly due to the reduction in tobacco use (change index: -0.25, 95% CI: -0.42 to -0.09). Our findings suggest that a community-based peer-support lifestyle intervention could reduce CVD risk in individuals at high-risk of developing diabetes in India. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.",2020,"The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years.","['1007 individuals (aged 30-60\u202fyears) at high-risk for diabetes (Indian Diabetes Risk Score\u202f≥\u202f60 and without diabetes) in Kerala state, India', 'Sixty polling areas in Kerala', 'The mean age at baseline was 46.0 (SD: 7.5) years, and 47.2% were women', 'high-risk individuals for diabetes in a low- and middle-income setting', 'Participants from 30 intervention communities received a 12-month', 'individuals at high-risk of developing diabetes in a low- and middle-income setting']","['structured peer-support lifestyle intervention program involving 15 group sessions and linked community activities, aimed at supporting and maintaining lifestyle change', 'lifestyle intervention', 'community-based peer-support lifestyle intervention']","['predicted 10-year CVD risk', 'Baseline 10-year CVD risk', 'CVD risk', 'cardiovascular disease (CVD) risk', 'Framingham Risk Score', 'cardiovascular risk', '10-year CVD risk']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443018', 'cui_str': 'Kerala (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0862494,"The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years.","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Population Health Research Institute, McMaster University, Hamilton, Canada. Electronic address: speaktosat@gmail.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Centre for Online Health, Centre for Health Services Research, University of Queensland, Australia.'}, {'ForeName': 'Robyn Jennifer', 'Initials': 'RJ', 'LastName': 'Tapp', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; School of Biomedical Engineering and Imaging Sciences, Kings College London, United Kingdom.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Kapoor', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, India.'}, {'ForeName': 'Kavumpurathu Raman', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, India; Department of Public Health and Community Medicine, Central University of Kerala, Kasaragod, Kerala, India.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; WHO Collaborating Centre on Implementation Research for Prevention & Control of NCDs, University of Melbourne, Australia.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106068']
663,31884854,"Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.","While hypertension and inflammation are physiologically inter-related, the effect of therapies that specifically target inflammation on blood pressure is uncertain. The recent CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) afforded the opportunity to test whether IL (interleukin)-1β inhibition would reduce blood pressure, prevent incident hypertension, and modify relationships between hypertension and cardiovascular events. CANTOS randomized 10 061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg/L to canakinumab 50 mg, 150 mg, 300 mg, or placebo. A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension. In patients without baseline hypertension, rates of incident hypertension were 23.4, 26.6, and 28.1 per 100-person years for the lowest to highest baseline tertiles of hsCRP ( P >0.2). In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2). IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates. These analyses suggest that the mechanisms underlying this benefit are not related to changes in blood pressure or incident hypertension. Clinical Trial Registration- URL: https://clinicaltrials.gov. Unique identifier: NCT01327846.",2020,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","['061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg', 'A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension']","['L to canakinumab 50 mg, 150 mg, 300 mg, or placebo', 'Interleukin-1β Inhibition', 'IL (interleukin)-1β inhibition']","['Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk', 'blood pressure or incident hypertension', 'rates of incident hypertension', 'incident hypertension', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.224736,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","[{'ForeName': 'Alexander Mk', 'Initials': 'AM', 'LastName': 'Rothman', 'Affiliation': 'From the Department of Cardiology, Chesterman Cardiothoracic Unit, Northern General Hospital, Sheffield, United Kingdom (A.M.K.R.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ (T.T.).'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Department of Clinical Neurosciences, University of Oxford, United Kingdom (A.W.).'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harrison', 'Affiliation': 'Vanderbilt University, Nashville, TN (D.G.H.).'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Institute of Cardiovascular and Medical Research, Queen Elizabeth University Hospital, University of Glasgow (T.J.G.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division (P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13642']
664,31515736,"""Getting Everyone on the Same Page"": Interprofessional Team Training to Develop Shared Mental Models on Interprofessional Rounds.","AIM


This study aimed to evaluate the effect of a team training program to support shared mental model (SMM) development in interprofessional rounds.
DESIGN AND PARTICIPANTS


A three-arm randomized controlled trial study was conducted for interprofessional teams of 207 health profession learners who were randomized into three groups.
PROGRAM DESCRIPTION


The full team training program included a didactic training part on cognitive tools and a virtual simulation to support clinical teamwork in interprofessional round. Group 1 was assigned to the full program, group 2 to the didactic part, and group 3 (control group) with no intervention. The main outcome measure was team performance in full scale simulation. Secondary outcome was interprofessional attitudes.
PROGRAM EVALUATION


Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group. The two intervention groups had significantly higher (P < 0.05) attitude scores on interprofessional teamwork compared with the control group.
DISCUSSION


Our study indicates the need of both cognitive tools and experiential learning modalities to foster SMM development for the delivery of optimal clinical teamwork performances. Given its scalability and practicality, we anticipate a greater role for virtual simulations to support interprofessional team training.",2019,Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group.,['207 health profession learners who were randomized into three groups'],"['team training program', 'didactic part, and group 3 (control group) with no intervention', 'didactic training part on cognitive tools and a virtual simulation to support clinical teamwork in interprofessional round']","['attitude scores on interprofessional teamwork', 'team performance in full scale simulation', 'interprofessional attitudes', 'Teamwork performance and interprofessional attitude scores']","[{'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",,0.0354043,Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group.,"[{'ForeName': 'Sok Ying', 'Initials': 'SY', 'LastName': 'Liaw', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. nurliaw@nus.edu.sg.'}, {'ForeName': 'Ling Ting', 'Initials': 'LT', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Lai Fun', 'Initials': 'LF', 'LastName': 'Wong', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Shawn Leng Hsien', 'Initials': 'SLH', 'LastName': 'Soh', 'Affiliation': 'Health and Social Sciences Cluster, Singapore Institute of Technology, Singapore, Singapore.'}, {'ForeName': 'Yeow Leng', 'Initials': 'YL', 'LastName': 'Chow', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ringsted', 'Affiliation': 'Center for Health Science Education at the Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Tang Ching', 'Initials': 'TC', 'LastName': 'Lau', 'Affiliation': 'Yong Loo Lin School Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wee Shiong', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Yong Loo Lin School Medicine, National University of Singapore, Singapore, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-019-05320-z']
665,31801902,Phase IIIb Safety and Efficacy of Intravenous NEPA for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients with Breast Cancer Receiving Initial and Repeat Cycles of Anthracycline and Cyclophosphamide (AC) Chemotherapy.,"BACKGROUND


NEPA, a combination antiemetic of a neurokinin-1 (NK 1 ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3 RA, palonosetron] offers 5-day CINV prevention with a single dose. Fosnetupitant solution contains no allergenic excipients, surfactant, emulsifier, or solubility enhancer. A phase III study of patients receiving cisplatin found no infusion-site or anaphylactic reactions related to IV NEPA. However, hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1 RAs, particularly fosaprepitant in patients receiving anthracycline-cyclophosphamide (AC)-based chemotherapy. This study evaluated the safety and efficacy of IV NEPA in the AC setting.
MATERIALS AND METHODS


This phase IIIb, multinational, randomized, double-blind study enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy. Patients were randomized to receive a single 30-minute infusion of IV NEPA or single oral NEPA capsule on day 1 prior to AC, in repeated (up to 4) cycles. Oral dexamethasone was given to all patients on day 1 only.
RESULTS


A total of 402 patients were included. The adverse event (AE) profiles were similar for IV and oral NEPA and consistent with those expected. Most AEs were mild or moderate with a similarly low incidence of treatment-related AEs in both groups. There were no treatment-related injection-site AEs and no reports of hypersensitivity or anaphylaxis. The efficacy of IV and oral NEPA were similar, with high complete response (no emesis/no rescue) rates observed in cycle 1 (overall [0-120 hours] 73.0% IV NEPA, 77.3% oral NEPA) and maintained over subsequent cycles.
CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
IMPLICATIONS FOR PRACTICE


As a combination of a neurokinin-1 (NK 1 ) receptor antagonist (RA) and 5-HT 3 RA, NEPA offers 5-day chemotherapy-induced nausea and vomiting prevention with a single dose and an opportunity to improve adherence to antiemetic guidelines. In this randomized multinational phase IIIb study, intravenous (IV) NEPA (fosnetupitant/palonosetron) was safe and highly effective in patients receiving multiple cycles of anthracycline-cyclophosphamide (AC)-based chemotherapy. Unlike other IV NK 1 RAs, the IV NEPA combination solution does not require any surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. Hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1 RAs, most commonly with fosaprepitant in the AC setting. Importantly, there were no injection-site or hypersensitivity reactions associated with IV NEPA.",2019,"CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
","['patients receiving multiple cycles of', 'enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy', 'patients receiving AC', 'A total of 402 patients were included', 'Patients with Breast Cancer']","['anthracycline-cyclophosphamide (AC)-based chemotherapy', 'Oral dexamethasone', 'Anthracycline and Cyclophosphamide', 'IV and oral NEPA', 'neurokinin-1 (NK 1 ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3 RA, palonosetron', 'intravenous (IV) NEPA (fosnetupitant/palonosetron', 'neurokinin-1 (NK 1 ) receptor antagonist (RA) and 5-HT 3 RA, NEPA', 'cisplatin', 'IV NEPA or single oral NEPA capsule', 'IV NEPA', 'Intravenous NEPA']","['adverse event (AE) profiles', 'hypersensitivity and injection-site reactions', 'injection-site or hypersensitivity reactions', 'Nausea and Vomiting (CINV', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4691680', 'cui_str': 'fosnetupitant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",402.0,0.0576046,"CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'Hematology & Oncology, West Cancer Center, Germantown, Tennessee, USA lschwartzberg@westclinic.com.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Navari', 'Affiliation': 'Department of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Clark-Snow', 'Affiliation': 'Overland Park, Kansas, USA.'}, {'ForeName': 'Ekaterine', 'Initials': 'E', 'LastName': 'Arkania', 'Affiliation': 'The Institute of Clinical Oncology, Tbilisi, Georgia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Radyukova', 'Affiliation': 'Department of Chemotherapy, Clinical Oncology Center, Omsk, Russia.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'CARTI Cancer Center, Little Rock, Arkansas, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wickham', 'Affiliation': 'Rapid River, Michigan, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Department of Medical Oncology, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': 'Cancer Centre, Clinique de Genolier, Genolier, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roeland', 'Affiliation': 'Oncology & Palliative Care, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0527']
666,32189094,"Delegating Clozapine Monitoring to Advanced Nurse Practitioners: An Exploratory, Randomized Study to Assess the Effect on Prescription and Its Safety.","To test whether: (1) psychiatrists will prescribe clozapine more often if they can delegate the monitoring tasks to an advanced nurse practitioner (ANP), (2) clozapine monitoring by an ANP is at least as safe as monitoring by a psychiatrist. Patients from 23 Dutch outpatient teams were assessed for an indication for clozapine. ANPs affiliated to these teams were randomized to Condition A: clozapine monitoring by an ANP, or Condition B: monitoring by the psychiatrist. The safety of monitoring was evaluated by determining whether the weekly neutrophil measurements were performed. Staff and patients were blinded regarding the first hypothesis. Of the 173 patients with an indication for clozapine at baseline, only seven in Condition A and four in Condition B were prescribed clozapine (Odds Ratio = 2.24, 95% CI 0.61-8.21; p = 0.225). These low figures affected the power of this study. When we considered all patients who started with clozapine over the 15-month period (N = 49), the Odds Ratio was 1.90 (95% CI 0.93-3.87; p = 0.078). With regard to the safety of the monitoring of the latter group of patients, 71.2% of the required neutrophil measurements were performed in condition A and 67.3% in condition B (OR = 0.98; CI = 0.16-3.04; p = 0.98). Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring. Clozapine-monitoring performed by an ANP seemed as safe as that by a psychiatrist.",2020,"Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring.","['Advanced Nurse Practitioners', '173 patients with an indication for', 'Patients from 23 Dutch outpatient teams']","['Clozapine', 'clozapine']",['prescription rates'],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",173.0,0.0393801,"Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring.","[{'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'van der Zalm', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands. y.vanderzalm@rivierduinen.nl.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Schulte', 'Affiliation': 'Dutch Clozapine Collaboration Group, Castricum, The Netherlands.'}, {'ForeName': 'J P A M', 'Initials': 'JPAM', 'LastName': 'Bogers', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Termorshuizen', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'M A G B', 'Initials': 'MAGB', 'LastName': 'van Piere', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Neuroscience and Department of Psychiatry, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Selten', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Administration and policy in mental health,['10.1007/s10488-020-01031-4']
667,32096243,Free gingival grafts for implants exhibiting a lack of keratinized mucosa: Extended follow-up of a randomized controlled trial.,"INTRODUCTION


This study is an extended follow-up of a randomized controlled trial that evaluated 18-month outcomes following free gingival grafts (FGGs) around implants with <2 mm keratinized mucosa (KM) compared to implants without KM augmentation.
MATERIALS AND METHODS


Follow-up data were obtained over 48 months from 18 implants in the FGG group (11 subjects) and 8 implants in the no-surgery group (7 subjects) within the control group. FGGs were performed after 18 months for 8 implants in the control group; these 8 implants constituted a delayed FGG group (5 subjects). The width of KM, mucosal recession (MR) and crestal bone level (CBL) were obtained.
RESULTS


The increased width of KM and the reduced MR following FGGs were maintained for 48 months in the FGG group, which exhibited less MR than the no-surgery group. The amount of crestal bone loss (0.4 ± 0.4 mm) in the no-surgery group was significantly greater than that in the FGG group (0 ± 0.4 mm) at 48 months. In the delayed FGG group, reduced MR and no significant differences in CBL were observed compared with the pre-graft measurements.
CONCLUSIONS


FGGs can be a practical treatment option to maintain CBL around implants with limited KM.",2020,The amount of crestal bone loss (0.4 ± 0.4 mm) in the no-surgery group was significantly greater than that in the FGG group (0 ± 0.4 mm) at 48 months.,"['Follow-up data were obtained over 48 months from 18 implants in the FGG group (11 subjects) and 8 implants in the no-surgery group (7 subjects) within the control group', 'implants exhibiting a lack of keratinized mucosa']","['free gingival grafts (FGGs) around implants with < 2 mm keratinized mucosa (KM', 'FGG']","['CBL', 'crestal bone loss', 'width of KM, mucosal recession (MR), and crestal bone level (CBL', 'increased width of KM and the reduced MR following FGGs']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]","[{'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site (procedure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]","[{'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",,0.0698514,The amount of crestal bone loss (0.4 ± 0.4 mm) in the no-surgery group was significantly greater than that in the FGG group (0 ± 0.4 mm) at 48 months.,"[{'ForeName': 'Se-Lim', 'Initials': 'SL', 'LastName': 'Oh', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, School of Dentistry, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, School of Dentistry, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Azad', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, School of Dentistry, University of Maryland, Baltimore, MD, USA.'}]",Journal of clinical periodontology,['10.1111/jcpe.13272']
668,31381363,Low-Profile Dual Small Plate Fixation Is Biomechanically Similar to Larger Superior or Anteroinferior Single Plate Fixation of Midshaft Clavicle Fractures.,"BACKGROUND


Limited biomechanical data exist for dual small plate fixation of midshaft clavicle fractures, and no prior study has concurrently compared dual small plating to larger superior or anteroinferior single plate and screw constructs.
PURPOSE


To biomechanically compare dual small orthogonal plating, superior plating, and anteroinferior plating of midshaft clavicle fractures by use of a cadaveric model.
STUDY DESIGN


Descriptive laboratory study.
METHODS


The study used 18 cadaveric clavicle specimens (9 pairs total), and 3 plating techniques were studied: anteroinferior, superior, and dual. The dual plating technique used smaller diameter plates and screws (1.6-mm thickness) than the other, single plate techniques (3.3-mm thickness). Each of the 9 clavicle pairs was randomly assigned a combination of 2 plating techniques, and randomization was used to determine which techniques were used for the right and left specimens. Clavicles were plated and then osteotomized to create an inferior butterfly fracture model, which was then fixed with a single interfragmentary screw. Clavicle specimens were then potted for mechanical testing. Initial bending, axial, and torsional stiffness of each construct was determined through use of a randomized nondestructive cyclic testing protocol followed by load to failure.
RESULTS


No significant differences were found in cyclical axial ( P  = .667) or torsional ( P  = .526) stiffness between plating groups. Anteroinferior plating demonstrated significantly higher cyclical bending stiffness than superior plating ( P  = .005). No significant difference was found in bending stiffness between dual plating and either anteroinferior ( P  = .129) or superior plating ( P  = .067). No significant difference was noted in load to failure among plating methods ( P  = .353).
CONCLUSION


Dual plating with a smaller plate-screw construct is biomechanically similar to superior and anteroinferior single plate fixation that uses larger plate-screw constructs. No significant differences were found between dual plating and either superior or anteroinferior single plating in axial, bending, or torsional stiffness or in bending load to failure. Dual small plating is a viable option for fixing midshaft clavicle fractures and may be a useful low-profile technique that avoids a larger and more prominent plate-screw construct.
CLINICAL RELEVANCE


Plate prominence and hardware irritation are commonly reported complaints and reasons for revision surgery after plate fixation of midshaft clavicle fractures. Dual small plate fixation has been used to improve cosmetic acceptability, minimize hardware irritation, and decrease reoperation rate. Biomechanically, dual small plate fixation performed similarly to larger single plate fixation in this cadaveric model of butterfly fracture.",2019,No significant difference was found in bending stiffness between dual plating and either anteroinferior ( P  = .129) or superior plating ( P  = .067).,"['18 cadaveric clavicle specimens (9 pairs total), and 3 plating techniques were studied: anteroinferior, superior, and dual', '9 clavicle pairs']","['Dual small plating', 'Low-Profile Dual Small Plate Fixation', 'Dual small plate fixation']","['cyclical bending stiffness', 'bending stiffness', 'dual plating and either superior or anteroinferior single plating in axial, bending, or torsional stiffness', 'cosmetic acceptability', 'reoperation rate', 'cyclical axial', 'load to failure']","[{'cui': 'C0008913', 'cui_str': 'Clavicle'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0205133', 'cui_str': 'Bent (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0450425', 'cui_str': 'Torsional (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0159917,No significant difference was found in bending stiffness between dual plating and either anteroinferior ( P  = .129) or superior plating ( P  = .067).,"[{'ForeName': 'Connor G', 'Initials': 'CG', 'LastName': 'Ziegler', 'Affiliation': 'New England Orthopedic Surgeons, Springfield, Massachusetts, USA.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Aman', 'Affiliation': 'The Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Hunter W', 'Initials': 'HW', 'LastName': 'Storaci', 'Affiliation': 'The Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Finch', 'Affiliation': 'The Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'Dornan', 'Affiliation': 'The Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Mitchell I', 'Initials': 'MI', 'LastName': 'Kennedy', 'Affiliation': 'The Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Provencher', 'Affiliation': 'The Steadman Clinic, Vail, Colorado, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hackett', 'Affiliation': 'The Steadman Clinic, Vail, Colorado, USA.'}]",The American journal of sports medicine,['10.1177/0363546519865251']
669,32007996,"Can Short Bouts of Exercise (""Exercise Snacks"") Improve Body Composition in Adolescents with Type 1 Diabetes? A Feasibility Study.","INTRODUCTION


Puberty is associated with a deterioration of blood glucose control in children with type 1 diabetes (T1D). The literature suggests that exercise improves homeostasis in adults with diabetes, but lack of time often precludes the performance of exercise. Besides, in earlier work, supplementation with glutamine, a nonessential amino acid, when administered prior to exercise, decreased overnight post-exercise blood glucose in adolescents with long-standing T1D, suggesting that glutamine increased insulin sensitivity or enhanced tissue glucose uptake. The purpose of the current study therefore was to determine the feasibility of a novel form of exercise (""exercise snacks,"" that is, short bouts of exercise spread throughout the day) with or without a supplemental amino acid, glutamine, and its impact on blood glucose homeostasis and body composition in adolescents with T1D.
METHODS


Twelve sedentary adolescents with T1D (HbA1c 8.1 ± 0.6%) performed exercise snacks (6 × 1 min of resistance-based activities) 3 times daily for 3 months; in addition, they were randomized to consume a drink containing either placebo or glutamine (0.5 g/kg/day). Continuous glucose monitoring, HbA1c, and dual X-ray absorptiometry were obtained before and after 3 months of each intervention.
RESULTS


Exercise snacks were easy to perform and well tolerated and were associated with a 2.2% loss of body fat mass when both groups were analyzed together (p = 0.015) after 3 months, whereas the change in lean body mass was not significant (p = 0.21). Metabolic control (HbA1c and glucose sensor data) was unchanged as result of the intervention regardless of group, and total daily insulin dose did not decrease.
CONCLUSION


Short bouts of exercise are sustainable over a 3-month period and can improve body composition in adolescents with poorly controlled T1D. Although metabolic control was unchanged as a result of the intervention regardless of group, this was a short-term intervention, hence assessment of metabolic impact will require long-term study.",2019,"Metabolic control (HbA1c and glucose sensor data) was unchanged as result of the intervention regardless of group, and total daily insulin dose did not decrease.
","['adolescents with T1D.\nMETHODS\n\n\nTwelve sedentary adolescents with T1D (HbA1c 8.1 ± 0.6%) performed', 'adolescents with poorly controlled T1D', 'children with type 1 diabetes (T1D', 'adults with diabetes', 'Adolescents with Type 1 Diabetes']","['exercise (""exercise snacks', 'Exercise (""Exercise Snacks', 'exercise snacks (6 × 1 min of resistance-based activities) 3 times daily for 3 months; in addition, they were randomized to consume a drink containing either placebo or glutamine']","['Metabolic control (HbA1c and glucose sensor data', 'body fat mass', 'lean body mass', 'easy to perform and well tolerated', 'insulin sensitivity or enhanced tissue glucose uptake', 'blood glucose homeostasis and body composition', 'body composition', 'Body Composition', 'Continuous glucose monitoring, HbA1c, and dual X-ray absorptiometry']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",12.0,0.0434383,"Metabolic control (HbA1c and glucose sensor data) was unchanged as result of the intervention regardless of group, and total daily insulin dose did not decrease.
","[{'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': ""Division of Pediatric Endocrinology, Diabetes and Metabolism, Nemours Children's Health System, Jacksonville, Florida, USA.""}, {'ForeName': 'Deliamille', 'Initials': 'D', 'LastName': 'Perez-Santiago', 'Affiliation': ""Division of Pediatric Endocrinology, Diabetes and Metabolism, Nemours Children's Health System, Jacksonville, Florida, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Churilla', 'Affiliation': 'Department of Clinical and Applied Movement Sciences, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Montes', 'Affiliation': 'Department of Clinical and Applied Movement Sciences, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Jobayer', 'Initials': 'J', 'LastName': 'Hossain', 'Affiliation': 'Department of Biostatistics, Nemours/Alfred. I. duPont Hospital for Children, Wilmington, Delaware, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mauras', 'Affiliation': ""Division of Pediatric Endocrinology, Diabetes and Metabolism, Nemours Children's Health System, Jacksonville, Florida, USA.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Darmaun', 'Affiliation': ""Division of Pediatric Endocrinology, Diabetes and Metabolism, Nemours Children's Health System, Jacksonville, Florida, USA, ddarmaun@gmail.com.""}]",Hormone research in paediatrics,['10.1159/000505328']
670,31101403,Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD.,"RATIONALE & OBJECTIVE


Hyperglycemia exacerbates the progression of chronic kidney disease (CKD), but most glucose-lowering therapies do not address morbidities associated with CKD. Sodium/glucose cotransporter 2 (SGLT2) inhibitors offer potential benefits to patients with diabetes and CKD, but their effectiveness may be diminished with decreased kidney function. We aimed to evaluate the safety and effectiveness of bexagliflozin, a novel SGLT2 inhibitor, in patients with type 2 diabetes and CKD.
STUDY DESIGN


Phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial.
SETTING & PARTICIPANTS


54 sites across 4 countries. Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A 1c  level of 7.0% to 10.5% and estimated glomerular filtration rate (eGFR) of 30 to 59mL/min/1.73m 2  who were taking oral hypoglycemic agents for 8 weeks.
INTERVENTIONS


Bexagliflozin, 20mg, daily versus placebo for 24 weeks.
OUTCOMES


Primary outcome was change in percent hemoglobin A 1c  from baseline to week 24. Secondary end points included changes in body weight, systolic blood pressure, albuminuria, and hemoglobin A 1c  level stratified by CKD stage.
RESULTS


312 patients across 54 sites were analyzed. Bexagliflozin lowered hemoglobin A 1c  levels by 0.37% (95% CI, 0.20%-0.54%); P<0.001 compared to placebo. Patients with CKD stages 3a (eGFR, 45-<60mL/min/1.73m 2 ) and 3b (eGFR, 30-<45mL/min/1.73m 2 ) experienced reductions in hemoglobin A 1c  levels of 0.31% (P=0.007) and 0.43% (P=0.002), respectively. Bexagliflozin decreased body weight (1.61kg; P<0.001), systolic blood pressure (3.8mm Hg; P=0.02), fasting plasma glucose level (0.76mmol/L; P=0.003), and albuminuria (geometric mean ratio reduction of 20.1%; P=0.03). Urinary tract infection and genital mycotic infections were more common in the bexagliflozin group; otherwise, frequencies of adverse events were comparable between groups.
LIMITATIONS


Not designed to evaluate the impact of treatment on long-term kidney disease and cardiovascular outcomes.
CONCLUSIONS


Bexagliflozin reduces hemoglobin A 1c  levels in patients with diabetes and stage 3a/3b CKD and appears to be well tolerated. Additional observed benefits included reductions in body weight, systolic blood pressure, and albuminuria.
FUNDING


Trial was sponsored by Theracos Sub, LLC.",2019,"Bexagliflozin decreased body weight (1.61kg; P<0.001), systolic blood pressure (3.8mm Hg; P=0.02), fasting plasma glucose level (0.76mmol/L; P=0.003), and albuminuria (geometric mean ratio reduction of 20.1%; P=0.03).","['Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD', 'patients with diabetes and CKD', 'Patients with CKD stages 3a (eGFR, 45-<60mL', 'Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A 1c  level of 7.0% to 10.5% and estimated glomerular filtration rate (eGFR) of 30 to', 'patients with type 2 diabetes and CKD', '312 patients across 54 sites were analyzed', '54 sites across 4 countries', 'patients with diabetes and stage 3a/3b CKD']","['Bexagliflozin, 20mg, daily versus placebo', 'placebo', 'bexagliflozin', 'Sodium/glucose cotransporter 2 (SGLT2) inhibitors', 'Bexagliflozin']","['Safety and Effectiveness', 'fasting plasma glucose level', 'changes in body weight, systolic blood pressure, albuminuria, and hemoglobin A 1c  level stratified by CKD stage', 'hemoglobin', 'body weight, systolic blood pressure, and albuminuria', 'change in percent hemoglobin', 'frequency of adverse events', 'systolic blood pressure', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C3811844'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.123553,"Bexagliflozin decreased body weight (1.61kg; P<0.001), systolic blood pressure (3.8mm Hg; P=0.02), fasting plasma glucose level (0.76mmol/L; P=0.003), and albuminuria (geometric mean ratio reduction of 20.1%; P=0.03).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Allegretti', 'Affiliation': 'Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, MA. Electronic address: aallegretti@mgh.harvard.edu.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA; Shanghai JiaYue PharmaTech, Shanghai, China.'}, {'ForeName': 'Wenjiong', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Hopkins Consulting LLC, Philadelphia, PA.'}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Thurber', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Rigby', 'Affiliation': 'Summit Research Group/Unity Health Network, Munroe Falls, OH.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Bowman-Stroud', 'Affiliation': 'Four Rivers Clinical Research, Paducah, KY.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Trescoli', 'Affiliation': 'Hospital Universitario de la Ribera, Valencia, Spain.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Serusclat', 'Affiliation': 'GHM les Portes du Sud, Venissieux, France.'}, {'ForeName': 'Mason W', 'Initials': 'MW', 'LastName': 'Freeman', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuan-Di C', 'Initials': 'YC', 'LastName': 'Halvorsen', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.03.417']
671,32088365,Improving Quality of Life in Hematopoietic Stem Cell Transplantation Survivors Through a Positive Psychology Intervention.,"Despite advances in transplantation medicine, psychological distress and quality of life and functional deficits continue to compromise survivorship after hematopoietic stem cell transplantation (HSCT). With increasing numbers of HSCT survivors, supportive oncology interventions that target health-related outcomes in HSCT survivorship are needed. Here we aimed to test the feasibility and acceptability of a group format phone-delivered positive psychology (PP) intervention in HSCT survivors. This is a one-arm pilot study design that adapted and tested an individual PP intervention used in cardiac disease to a phone-delivered group-based program for HSCT survivors who were .4 to 39 years post-transplantation. All participants received an 8-session weekly PP intervention. We assessed feasibility by the enrollment and intervention completion rates. We examined acceptability on a 10-point Likert scale of ease and utility. Unstructured qualitative interviews were used to obtain participant feedback on the intervention for future application in a larger trial. Self-reported assessments on psychological, functional, and quality of life outcomes were administered at baseline and at follow-up (the end of the intervention). Of 64 eligible participants, 29 (45%) enrolled in the study. For the main aim of intervention feasibility and acceptability, participants completed 96% of all PP sessions and rated the ease (7.6 ± 1.7) and utility (8.1 ± 1.1) of sessions highly. Of the self-reported assessments obtained, the PP intervention resulted in improvements in the resilience scale (mean difference, 2.4 ± 5.4; P = .03). From unstructured qualitative interviews, participants reported the PP exercises and intervention helped them to focus on positive emotions and the group format fostered a sense of community and social support. An 8-week phone-delivered group format PP intervention is feasible and acceptable in HSCT survivors. The piloted intervention could be tested with minor modifications in a randomized study to definitively examine the impact of the group format PP intervention on health-related outcomes.",2020,"Of the self-reported assessments obtained, the PP intervention resulted in improvements in the resilience scale (mean difference 2.4 [SD 5.4], p=0.03).","['hematopoietic stem cell transplant survivors', '64 eligible participants, 29 (45%) enrolled in the study', 'HSCT survivors who were 0.4 to 39 years post-transplant', 'HSCT survivors']","['phone-delivered group format PP intervention', 'PP intervention', 'hematopoietic stem cell transplantation (HSCT', 'group format phone-delivered positive psychology (PP) intervention', 'individual PP intervention']","['10-point Likert scale of ease and utility', 'psychological, functional, and quality of life outcomes', 'Improving quality of life', 'resilience scale', 'feasibility and acceptability']","[{'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",64.0,0.0756091,"Of the self-reported assessments obtained, the PP intervention resulted in improvements in the resilience scale (mean difference 2.4 [SD 5.4], p=0.03).","[{'ForeName': 'Hermioni L', 'Initials': 'HL', 'LastName': 'Amonoo', 'Affiliation': ""Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Department of Psychiatry, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Chareeni', 'Initials': 'C', 'LastName': 'Kurukulasuriya', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Chilson', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Onstad', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston Massachusetts.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington; Department of Medicine, University of Washington, Seattle, Washington. Electronic address: sjlee@fredhutch.org.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.02.013']
672,31313110,Electronic Health Record Mortality Prediction Model for Targeted Palliative Care Among Hospitalized Medical Patients: a Pilot Quasi-experimental Study.,"BACKGROUND


Development of electronic health record (EHR) prediction models to improve palliative care delivery is on the rise, yet the clinical impact of such models has not been evaluated.
OBJECTIVE


To assess the clinical impact of triggering palliative care using an EHR prediction model.
DESIGN


Pilot prospective before-after study on the general medical wards at an urban academic medical center.
PARTICIPANTS


Adults with a predicted probability of 6-month mortality of ≥ 0.3.
INTERVENTION


Triggered (with opt-out) palliative care consult on hospital day 2.
MAIN MEASURES


Frequencies of consults, advance care planning (ACP) documentation, home palliative care and hospice referrals, code status changes, and pre-consult length of stay (LOS).
KEY RESULTS


The control and intervention periods included 8 weeks each and 138 admissions and 134 admissions, respectively. Characteristics between the groups were similar, with a mean (standard deviation) risk of 6-month mortality of 0.5 (0.2). Seventy-seven (57%) triggered consults were accepted by the primary team and 8 consults were requested per usual care during the intervention period. Compared to historical controls, consultation increased by 74% (22 [16%] vs 85 [63%], P < .001), median (interquartile range) pre-consult LOS decreased by 1.4 days (2.6 [1.1, 6.2] vs 1.2 [0.8, 2.7], P = .02), ACP documentation increased by 38% (23 [17%] vs 37 [28%], P = .03), and home palliative care referrals increased by 61% (9 [7%] vs 23 [17%], P = .01). There were no differences between the control and intervention groups in hospice referrals (14 [10] vs 22 [16], P = .13), code status changes (42 [30] vs 39 [29]; P = .81), or consult requests for lower risk (< 0.3) patients (48/1004 [5] vs 33/798 [4]; P = .48).
CONCLUSIONS


Targeting hospital-based palliative care using an EHR mortality prediction model is a clinically promising approach to improve the quality of care among seriously ill medical patients. More evidence is needed to determine the generalizability of this approach and its impact on patient- and caregiver-reported outcomes.",2019,"There were no differences between the control and intervention groups in hospice referrals (14 [10] vs 22 [16], P = .13), code status changes (42 [30] vs 39 [29]; P = .81), or consult requests for lower risk (< 0.3) patients (48/1004 [5] vs 33/798 [4]; P = .48).
","['general medical wards at an urban academic medical center', 'Hospitalized Medical Patients', 'Adults with a predicted probability of 6-month mortality of ≥\u20090.3', 'Targeted Palliative Care', 'Seventy-seven (57%) triggered consults were accepted by the primary team and 8 consults were requested per usual care during the intervention period', 'seriously ill medical patients']",[],"['median (interquartile range) pre-consult LOS', 'hospice referrals', 'home palliative care referrals', 'ACP documentation', 'quality of care', 'Frequencies of consults, advance care planning (ACP) documentation, home palliative care and hospice referrals, code status changes, and pre-consult length of stay (LOS']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",138.0,0.0646268,"There were no differences between the control and intervention groups in hospice referrals (14 [10] vs 22 [16], P = .13), code status changes (42 [30] vs 39 [29]; P = .81), or consult requests for lower risk (< 0.3) patients (48/1004 [5] vs 33/798 [4]; P = .48).
","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Courtright', 'Affiliation': 'Department of Medicine at the Perelman School of Medicine, University of Pennsylvania, 303 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104, USA. katherine.courtright@pennmedicine.upenn.edu.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'Predictive Healthcare at Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becker', 'Affiliation': 'Predictive Healthcare at Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Regli', 'Affiliation': 'Center for Evidence-based Practice to Clinical Effectiveness and Quality Improvement (CEQI) at Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Linnea C', 'Initials': 'LC', 'LastName': 'Pepper', 'Affiliation': 'Department of Medicine at the Perelman School of Medicine, University of Pennsylvania, 303 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Draugelis', 'Affiliation': 'Predictive Healthcare at Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine at the Perelman School of Medicine, University of Pennsylvania, 303 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05169-2']
673,32193624,Use of a Discharge Educational Strategy Versus Standard Discharge Care on Reduction of Vascular Risk in Patients with Stroke and Transient Ischemic Attack.,"PURPOSE OF THE REVIEW


The burden of ischemic stroke is disproportionally distributed between ethnic and racial subgroups in the USA, minority populations with lower socioeconomic status being at higher risk. These discrepancies are mirrored in susceptibility, primary care, and post-discharge procedures. Post-discharge strategies are of particular importance as their primary goal is to prevent recurrent stroke, which makes up about 25% of stroke cases per year in US. As disadvantaged minorities have faster growing populations, recurrent stroke poses a significant challenge not only for caretakers but also for the health care system as the whole. A number of educational strategies were employed to inform the general public of major symptoms, risk factors, and preventive measures for recurrent stroke. However, over affected subgroups did not prove responsive to such measures as these did not conform to their cultural and sociological specificities.
RECENT FINDINGS


The Discharge Educational Strategies for Reduction of Vascular Events Intervention (DESERVE) is a randomized control trial with a one year follow up, set out to investigate the possibility that culturally tailored, community-centered post-discharge strategies would improve compliance to therapy and prevention against secondary stroke. The trial targeted African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group. DESERVE accomplished a significant reduction in blood pressure in the Hispanic intervention group by 9.9 mm Hg compared with usual care. The remaining two groups were not susceptible to these measures. DESERVE holds promise for culturally tailored interventions in the future in a battle against stroke and other chronic diseases.",2020,The remaining two groups were not susceptible to these measures.,"['Patients with Stroke and Transient Ischemic Attack', 'African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group']",['Discharge Educational Strategy Versus Standard Discharge Care'],"['blood pressure', 'burden of ischemic stroke', 'Vascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0205169,The remaining two groups were not susceptible to these measures.,"[{'ForeName': 'Anantha R', 'Initials': 'AR', 'LastName': 'Vellipuram', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA. anantha-ramana.vellipuram@ttuhsc.edu.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Rawla', 'Affiliation': 'Department of Internal Medicine/Hospitalist, Sovah Health, Martinsville, VA, 24112, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Maud', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Cruz-Flores', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01283-4']
674,31767795,"Prognostic and Predictive Value of Microsatellite Instability, Inflammatory Reaction and PD-L1 in Gastric Cancer Patients Treated with Either Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel: A Translational Analysis from the ITACA-S Trial.","BACKGROUND


Patients with high microsatellite instability (MSI) gastric cancer (GC) show improved survival and no benefit or harm from adjuvant and/or perioperative chemotherapy. The role of immune microenvironment in GC is largely unknown.
MATERIALS AND METHODS


In the present study, 256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S, a randomized adjuvant trial of 5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel. MSI status was assessed by multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry.
RESULTS


Overall, 9% patients had MSI-high tumors, 23% had high inflammatory reaction, 11% had tumor PD-L1 ≥ 1%, and 11% had stromal PD-L1 ≥ 1%. A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43;  p  = .02; HR, 0.40;  p  = .02) and high inflammatory reaction (HR, 0.55;  p  = .010; HR, 0.53;  p  = .008) but not for PD-L1. At multivariable analysis, only MSI showed an independent association with both DFS ( p  = .02) and OS ( p  = .01), whereas inflammatory reaction showed an independent association only with OS ( p  = .04). Patients with tumor PD-L1 ≥ 1% had a significantly longer DFS in sequential chemotherapy than in than 5-FU/LV arm (interaction  p  = .04) and a trend for OS (interaction  p  = .12).
CONCLUSION


Our data suggest that MSI status could be a useful prognostic biomarker in patients with radically resected stage II-III GC and should be used as stratification factor in future trials. Tumor PD-L1 ≥ 1% should be further investigated as a potential predictor of benefit from intensive chemotherapy.
IMPLICATIONS FOR PRACTICE


In this post hoc analysis of patients with radically resected gastric cancer randomized to an intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy as adjuvant treatment in the ITACA-S trial, MSI-high status was independently associated with better disease-free survival and overall survival (OS) and inflammatory reaction was independently associated with better OS. Moreover, tumor PD-L1 expression ≥1% was associated with greater benefit from intensive sequential chemotherapy compared with 5-fluorouracil plus leucovorin (5-FU/LV), whereas PD-L1 expression <1% was not, conditioning a statistically significant interaction between such biomarker and treatment arms. The meta-analysis of individual patients' data from available studies could yield data on the role of MSI status that could inform clinical decisions.",2019,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43;  ","['Gastric Cancer Patients Treated with Either', '256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S', 'patients with radically resected gastric cancer', 'Patients with high microsatellite instability (MSI) gastric cancer (GC']","['5-fluorouracil plus leucovorin (5-FU/LV', '5-FU/LV', '5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel', 'intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy', 'Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel']","['disease-free survival and overall survival (OS) and inflammatory reaction', 'high inflammatory reaction', 'multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry', 'inflammatory reaction', 'MSI status', 'DFS', 'disease-free survival (DFS) and overall survival (OS', 'PD-L1 expression']","[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0920269', 'cui_str': 'Microsatellite Instability'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3179032', 'cui_str': 'Multiplex PCR'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",256.0,0.129712,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43;  ","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy maria.dibartolomeo@istitutotumori.mi.it.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Antista', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Niger', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pellegrinelli', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Randon', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0471']
675,31771987,Effect of a Skills Training for Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment: A Randomized Clinical Trial.,"BACKGROUND


Palliative systematic treatment offers uncertain and often limited benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). This trial examined the independent and combined effect of an oncologist training and a patient communication aid on SDM.
METHODS


In this multicenter randomized controlled trial with four parallel arms (2016-2018), oncologists ( n  = 31) were randomized to receive SDM communication skills training or not. The training consisted of a reader, two group sessions, a booster session, and a consultation room tool (10 hours). Patients ( n  = 194) with advanced cancer were randomized to receive a patient communication aid or not. The aid consisted of education on SDM, a question prompt list, and a value clarification exercise. The primary outcome was observed SDM as rated by blinded observers from audio-recorded consultations. Secondary outcomes included patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made.
RESULTS


The oncologist training had a large positive effect on observed SDM (Cohen's  d  = 1.12) and on patient-reported SDM ( d  = 0.73). The patient communication aid did not improve SDM. The combination of interventions did not add to the effect of training oncologists only. The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
CONCLUSION


Training medical oncologists in SDM about palliative systemic treatment improves both observed and patient-reported SDM. A patient communication aid does not. The incorporation of skills training in (continuing) educational programs for medical oncologists is likely to stimulate the widely advocated uptake of shared decision making in clinical practice.  Trial registration . Netherlands Trial Registry NTR 5489.
IMPLICATIONS FOR PRACTICE


Treatment for advanced cancer offers uncertain and often small benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). SDM is increasingly advocated for ethical reasons and for its beneficial effect on patient outcomes. Few initiatives to stimulate SDM are evaluated in robust designs. This randomized controlled trial shows that training medical oncologists improves both observed and patient-reported SDM in clinical encounters ( n  = 194). A preconsultation communication aid for patients did not add to the effect of training oncologists. SDM training effectively changes oncologists' practice and should be implemented in (continuing) educational programs.",2019,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
","['Patients ( n  =\u2009194) with advanced cancer', 'four parallel arms (2016-2018), oncologists ( n  =\u200931', 'Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment']","['SDM training', 'SDM', 'SDM communication skills training or not', 'Skills Training', 'patient communication aid or not', 'oncologist training']","[""patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made"", 'observed SDM', 'decisional conflict, quality of life, consultation duration, or the decision made', 'SDM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]",,0.162469,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Henselmans', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands i.henselmans@amc.uva.nl.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pomme', 'Initials': 'P', 'LastName': 'van Maarschalkerweerd', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke C J M', 'Initials': 'HCJM', 'LastName': 'de Haes', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helle-Brit', 'Initials': 'HB', 'LastName': 'Fiebrich', 'Affiliation': 'Department of Medical Oncology, Isalaklinieken, Zwolle, The Netherlands.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Dohmen', 'Affiliation': 'Department of Medical Oncology, BovenIJZiekenhuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharinaziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Filip Y F L', 'Initials': 'FYFL', 'LastName': 'de Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ellen M A', 'Initials': 'EMA', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0453']
676,32185595,"A prospective randomized trial comparing corifollitropin-α late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF.","OBJECTIVE


To assess whether corifollitropin-α (CFα) late-start administration (day 4) and standard administration (day 2) can obtain similar oocyte yield and live birth rate.
STUDY DESIGN


A randomized controlled trial.
SETTING


University Hospital IVF Unit.
PATIENTS


One hundred thirteen women undergoing IVF.
INTERVENTIONS


Patients distributed in three subgroups (expected poor, normal, or high responders to FSH) were randomized into two treatment arms: (a) CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH from day 11; (b) CFα standard start: CFα on day 2 + GnRH antagonist from day 6 + (when needed) recFSH from day 9. IVF or ICSI was performed as indicated.
RESULTS


Considering the whole study group, the late-start regimen obtained comparable oocyte yield (8.9 ± 5.6 vs. 8.8 ± 6.2; p = n.s.), cPR/started cycle (25% vs. 31.6%, p = n.s.), and cumulative live birth rate (LBR)/ovum pickup (OPU) (29.2% vs. 37.7%, p = n.s.) than the standard regimen. The outcome of the two regimens was comparable in the two subgroups of high and normal responders. Differently, in poor responders, oocyte yield was similar, but LBR/OPU was significantly lower with late-start CFα administration that caused 40% cancellation rate due to monofollicular response. ROC curves showed that the threshold AMH levels associated with cycle cancellation were 0.6 ng/ml for late-start regimen and 0.2 ng/ml for standard regimen.
CONCLUSION


CFα may be administered on either day 2 or day 4 to patients with expected high or normal response to FSH without compromising oocyte yield and/or live birth rate. Differently, late-start administration is not advisable for expected poor responders with AMH ≤ 0.6 ng/ml.
TRIAL REGISTRATION


NCT03816670.",2020,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"['One hundred thirteen women undergoing IVF', 'University Hospital IVF Unit']","['IVF or ICSI', 'corifollitropin-α late-start (day 4) versus standard administration', 'corifollitropin-α (CFα) late-start administration (day 4) and standard administration', 'CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH']","['oocyte yield', 'LBR/OPU', 'cumulative live birth rate (LBR)/ovum pickup (OPU', 'cPR/started cycle']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",113.0,0.17166,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy. alberto.revelli@unito.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sestero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Salvagno', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pittatore', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01742-5']
677,31801901,Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial.,"BACKGROUND


Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer.
MATERIALS AND METHODS


Eligible adult patients (≥18 years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score ≥17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and ≥4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress.
RESULTS


Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31-59) for olanzapine and 57% (95% CI, 43-71) for haloperidol (Δ DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2-1.4;  p  = .23). Mean TTR was 4.5 days (95% CI, 3.2-5.9 days) for olanzapine and 2.8 days (95% CI, 1.9-3.7 days;  p  = .18) for haloperidol. Grade ≥3 treatment-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility.
CONCLUSION


Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol.  Clinical trial identification number . NCT01539733.  Dutch Trial Register . NTR2559.
IMPLICATIONS FOR PRACTICE


Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.",2019,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","['Eligible adult patients (≥18\u2009years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98', 'adults with cancer', 'Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis', 'Patients with Advanced Cancer', 'hospitalized patients with advanced cancer', 'patients with advanced cancer', 'patients with cancer']","['haloperidol or olanzapine', 'olanzapine with haloperidol', 'Olanzapine', 'Olanzapine Versus Haloperidol', 'olanzapine', 'haloperidol']","['overall better safety profile', 'Grade ≥3 treatment-related adverse events', 'Mean TTR', 'efficacy and safety', 'delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score', 'DRR or TTR', 'Distress rates', 'DRR', 'efficacy and tolerability', 'time to response (TTR), tolerability, and delirium-related distress']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0222045'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",98.0,0.161751,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","[{'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth C W', 'Initials': 'ECW', 'LastName': 'Neefjes', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Manon S A', 'Initials': 'MSA', 'LastName': 'Boddaert', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Bea A T T', 'Initials': 'BATT', 'LastName': 'Verdegaal', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Saskia C C', 'Initials': 'SCC', 'LastName': 'Teunissen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke A', 'Initials': 'JA', 'LastName': 'Wilschut', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter W A', 'Initials': 'WWA', 'LastName': 'Zuurmond', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands Henk.Verheul@radboudumc.nl.'}]",The oncologist,['10.1634/theoncologist.2019-0470']
678,32100301,Health education decreases incidence of hand eczema in metal work apprentices: Results of a controlled intervention study.,"BACKGROUND


Metal work apprentices (MWAs) frequently develop work-related hand eczema (HE).
OBJECTIVES


To evaluate the effect of health education on incidence of work-related HE in MWAs and to assess confounding factors.
MATERIALS/METHODS


In a prospective controlled intervention study, 131 MWAs received educational training on prevention of HE, whereas 172 MWAs and 118 office work apprentices served as controls. At baseline and during three yearly follow-ups, questionnaires were completed and hands were examined. Saliva samples were collected for assessment of filaggrin (FLG) null mutations and an explorative genome-wide association study (GWAS), and levels of various cytokines were assessed from stratum corneum samples.
RESULTS


The 2-year and 3-year incidence of HE in the metalwork control group was 20.9% and 32.6%, respectively, which was significantly higher than in the intervention group (odds ratio [OR] 2.63, 95% confidence interval [CI] 1.31 to 5.28, P < .01 and OR 3.47, 95% CI 1.88 to 6.40, P < .0001). The knowledge score was higher in unaffected MWAs (P < .05). Other factors significantly associated with developing HE in MWAs were smoking cigarettes (P < .01) and FLG mutations (P < .001). No significant associations were found regarding epidermal cytokine levels and GWAS.
CONCLUSIONS


Health education is effective in primary prevention of HE in MWAs. Individual factors should be considered in targeted counseling.",2020,The knowledge score was higher in unaffected MWA (P < .05).,['hand eczema in metal work apprentices'],"['Health education', 'health education', 'educational training']","['FLG mutations', 'knowledge score', '2-year and 3-year incidence of HE', 'epidermal cytokine levels and GWAS']","[{'cui': 'C0239816', 'cui_str': 'Hand eczema (disorder)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0018701'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0468313,The knowledge score was higher in unaffected MWA (P < .05).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Reich', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Wilke', 'Affiliation': 'Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gediga', 'Affiliation': 'Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Baurecht', 'Affiliation': 'Department of Dermatology, Allergology and Venereology, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Dermatology, Allergology and Venereology, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ivone', 'Initials': 'I', 'LastName': 'Jakasa', 'Affiliation': 'Laboratory for Analytical Chemistry, Department of Chemistry and Biochemistry, Faculty of Food Technology and Biotechnology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Geier', 'Affiliation': 'Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mempel', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Buhl', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Weidinger', 'Affiliation': 'Department of Dermatology, Allergology and Venereology, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Kezic', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Swen M', 'Initials': 'SM', 'LastName': 'John', 'Affiliation': 'Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schön', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brans', 'Affiliation': 'Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Göttingen, Germany.'}]",Contact dermatitis,['10.1111/cod.13502']
679,30852132,"Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.","BACKGROUND


The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect.
METHODS


DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m 2 , and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA 1c  less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing.
FINDINGS


The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 7·49, 95% CI 2·05 to 27·32; p=0·0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (aOR 25·82, 8·25 to 80·84; p<0·0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was -5·4 kg (95% CI -6·9 to -4·0; p<0·0001) and in HbA 1c  was -4·8 mmol/mol (-8·3 to -1·4 [-0·44% (-0·76 to -0·13)]; p=0·0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
INTERPRETATION


The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss.
FUNDING


Diabetes UK.",2019,"Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
","['remission of type 2 diabetes', 'participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss', ""individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m 2 , and not receiving insulin between July 25, 2014, and Aug 5, 2016""]","['primary care-led weight-management intervention', 'computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size', 'withdrawal of antidiabetes and antihypertensive drugs, total diet replacement']","['intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes', 'weight loss', 'Sustained remission', 'remission of diabetes', 'Serious adverse events']","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.122103,"Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
","[{'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Barnes', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Brosnahan', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thom', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sviatlana', 'Initials': 'S', 'LastName': 'Zhyzhneuskaya', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Rodrigues', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Rehackova', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Adamson', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Falko F', 'Initials': 'FF', 'LastName': 'Sniehotta', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Ross', 'Affiliation': 'Counterweight Ltd, London, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'McIlvenna', 'Affiliation': 'College of Medical, Veterinary & Life Sciences, and General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Science, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kean', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claudia-Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Science, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. Electronic address: roy.taylor@newcastle.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30068-3']
680,31367875,Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial.,"BACKGROUND


Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation.
OBJECTIVE


To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation.
DESIGN


Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C.
MAIN MEASURES


Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge.
KEY RESULTS


Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6-12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)).
CONCLUSION


Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications.
TRIAL REGISTRATION


NCT01063972.",2019,"Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone.","['hospitalized smokers', '606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis', 'Hospitalized smokers referred from primarily rural hospitals']","[""Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy"", 'telephone counseling', 'Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge', 'CCC', 'smoking cessation counseling combined with care coordination post-hospitalization to counseling alone']","['Utilization of pharmacotherapy and smoking cessation', 'Self-reported abstinence rates', 'Validated smoking cessation']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0020023', 'cui_str': 'Hospitals, Rural'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",606.0,0.0510976,"Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone.","[{'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA. eellerbe@kumc.edu.'}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Siu-Kuen Azor', 'Initials': 'SA', 'LastName': 'Hui', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keighley', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Tresza D', 'Initials': 'TD', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'A Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'K Allen', 'Initials': 'KA', 'LastName': 'Greiner', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nancy Houston', 'Initials': 'NH', 'LastName': 'Miller', 'Affiliation': 'The LifeCare Company, Menlo Park, CA, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Rabius', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05220-2']
681,31688884,Effect of Caspofungin vs Fluconazole Prophylaxis on Invasive Fungal Disease Among Children and Young Adults With Acute Myeloid Leukemia: A Randomized Clinical Trial.,"Importance


Children, adolescents, and young adults with acute myeloid leukemia are at high risk of life-threatening invasive fungal disease with both yeasts and molds.
Objective


To compare the efficacy of caspofungin vs fluconazole prophylaxis against proven or probable invasive fungal disease and invasive aspergillosis during neutropenia following acute myeloid leukemia chemotherapy.
Design, Setting, and Participants


This multicenter, randomized, open-label, clinical trial enrolled patients aged 3 months to 30 years with newly diagnosed de novo, relapsed, or secondary acute myeloid leukemia being treated at 115 US and Canadian institutions (April 2011-November 2016; last follow-up June 30, 2018).
Interventions


Participants were randomly assigned during the first chemotherapy cycle to prophylaxis with caspofungin (n = 257) or fluconazole (n = 260). Prophylaxis was administered during the neutropenic period following each chemotherapy cycle.
Main Outcomes and Measures


The primary outcome was proven or probable invasive fungal disease as adjudicated by blinded central review. Secondary outcomes were invasive aspergillosis, empirical antifungal therapy, and overall survival.
Results


The second interim efficacy analysis and an unplanned futility analysis based on 394 patients appeared to have suggested futility, so the study was closed to accrual. Among the 517 participants who were randomized (median age, 9 years [range, 0-26 years]; 44% female), 508 (98%) completed the trial. The 23 proven or probable invasive fungal disease events (6 caspofungin vs 17 fluconazole) included 14 molds, 7 yeasts, and 2 fungi not further categorized. The 5-month cumulative incidence of proven or probable invasive fungal disease was 3.1% (95% CI, 1.3%-7.0%) in the caspofungin group vs 7.2% (95% CI, 4.4%-11.8%) in the fluconazole group (overall P = .03 by log-rank test) and for cumulative incidence of proven or probable invasive aspergillosis was 0.5% (95% CI, 0.1%-3.5%) with caspofungin vs 3.1% (95% CI, 1.4%-6.9%) with fluconazole (overall P = .046 by log-rank test). No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed. The most common toxicities were hypokalemia (22 caspofungin vs 13 fluconazole), respiratory failure (6 caspofungin vs 9 fluconazole), and elevated alanine transaminase (4 caspofungin vs 8 fluconazole).
Conclusions and Relevance


Among children, adolescents, and young adults with acute myeloid leukemia, prophylaxis with caspofungin compared with fluconazole resulted in significantly lower incidence of invasive fungal disease. The findings suggest that caspofungin may be considered for prophylaxis against invasive fungal disease, although study interpretation is limited by early termination due to an unplanned interim analysis that appeared to have suggested futility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01307579.",2019,"No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed.","['children, adolescents, and young adults with acute myeloid leukemia, prophylaxis with caspofungin compared with', 'probable invasive fungal disease and invasive aspergillosis during neutropenia following acute myeloid leukemia chemotherapy', 'Children and Young Adults', '394 patients', 'With Acute Myeloid Leukemia', '517 participants who were randomized (median age, 9 years [range, 0-26 years]; 44% female), 508 (98%) completed the trial', '23 proven or probable invasive fungal disease events (6 caspofungin vs 17 fluconazole) included 14 molds, 7 yeasts, and 2 fungi not further categorized', 'patients aged 3 months to 30 years with newly diagnosed de novo, relapsed, or secondary acute myeloid leukemia being treated at 115 US and Canadian institutions (April 2011-November 2016; last follow-up June 30, 2018', 'Importance\n\n\nChildren, adolescents, and young adults with acute myeloid leukemia']","['Caspofungin vs Fluconazole Prophylaxis', 'chemotherapy cycle to prophylaxis with caspofungin (n\u2009=\u2009257) or fluconazole', 'fluconazole', 'caspofungin vs fluconazole prophylaxis']","['5-month cumulative incidence of proven or probable invasive fungal disease', 'invasive aspergillosis, empirical antifungal therapy, and overall survival', 'invasive fungal disease', 'empirical antifungal therapy', '2-year overall survival', 'Invasive Fungal Disease', 'respiratory failure', 'cumulative incidence of proven or probable invasive aspergillosis', 'elevated alanine transaminase', 'proven or probable invasive fungal disease']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0369241', 'cui_str': 'Molds'}, {'cui': 'C0043393', 'cui_str': 'Yeasts'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]",517.0,0.189183,"No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed.","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fisher', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Theoklis', 'Initials': 'T', 'LastName': 'Zaoutis', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Dvorak', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Bone Marrow Transplant, University of California San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nieder', 'Affiliation': 'Division of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Zerr', 'Affiliation': ""Division of Pediatric Infectious Diseases, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'University of Florida College of Medicine, Gainesville.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Callahan', 'Affiliation': ""Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Doojduen', 'Initials': 'D', 'LastName': 'Villaluna', 'Affiliation': ""Children's Oncology Group, Monrovia, California.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, City of Hope, Duarte, California.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Esbenshade', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Wiley', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Sinai Hospital of Baltimore, Baltimore, Maryland.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",JAMA,['10.1001/jama.2019.15702']
682,32176674,Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Virtual reality (VR) training allows the creation of the most applicable practice environment incorporated into computer-generated multisensory imagery.
OBJECTIVES


The purpose of this study was to investigate the effects of a virtual training program based on a RAPAEL smart glove on the upper extremity function and quality of life of community-dwelling individuals with chronic hemiparetic stroke.
METHODS


Thirty-six outpatients diagnosed as having a first stroke were selected to receive a therapeutic rehabilitation program at local rehabilitation units. Participants were allocated randomly into two groups: the non-immersive VR training (intervention) group and the recreational activity (control) group. The intervention group received non-immersive VR training using a RAPAEL smart glove for 30 minutes per session, 3 days a week for 8 weeks. The control group performed recreational activities for the same period and also participated in a conventional rehabilitation program for 30 minutes per session, 3 days a week for 8 weeks as an additional therapy. To analyze the effects of the non-immersive VR intervention on upper extremity function, four clinical measures, namely the box and block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT), and a grip strength test, were used in this study. For the secondary clinical outcome, the trail-making test (TMT) was used to determine any improvement in cognitive function.
RESULTS


At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
CONCLUSIONS


This study suggests that virtual upper extremity training using the RAPAEL smart glove has reasonable and beneficial effects on upper extremity and cognitive function for chronic hemiparetic stroke survivors.",2020,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","['Stroke Patients', 'community-dwelling individuals with chronic hemiparetic stroke', 'chronic hemiparetic stroke survivors', 'Thirty-six outpatients diagnosed as having a first stroke']","['virtual training program', 'non-immersive VR intervention', 'Virtual reality (VR) training', 'non-immersive VR training', 'non-immersive VR training (intervention) group and the recreational activity (control) group', 'therapeutic rehabilitation program at local rehabilitation units']","['cognitive function', 'upper extremity function and quality of life', 'trail-making test (TMT', 'box-block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT', 'grip strength', 'recreational activities', 'WMFT scores', 'BBT scores']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0138026,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","[{'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': ""Department of Occupational Therapy, Gwang-ju Women's University, Gwangju, Republic of Korea.""}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Wonkwang Health Science University, Jeollabuk-do, Republic of Korea.'}, {'ForeName': 'Byeong-Hyeon', 'Initials': 'BH', 'LastName': 'Jeon', 'Affiliation': 'Department of Physical Therapy, Graduate school, Honam University, Gwangju, Republic of Korea.'}, {'ForeName': 'Chiang-Soon', 'Initials': 'CS', 'LastName': 'Song', 'Affiliation': 'Deparment of Occupational Therapy, College of Health Science, Chosun University, Gwangju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190975']
683,31418607,Effects of Messaging and Psychological Reactance on Marijuana Craving.,"Background : Psychological Reactance Theory asserts that people experience reactance (a motivational state characterized by negative affect and cognition) when they perceive threats to their autonomy. Reactance may lead to ""boomerang effects"" by which individuals engage in the opposed behavior.  Objectives : This experiment sought to determine whether a message encouraging marijuana (MJ) abstinence evoked greater reactance than a harm-reduction message and whether the message and reactance influenced individuals' attitudes, MJ craving, and intent to comply with the message request.  Methods : College students and community members ( n  = 388) participated in an online study where they were randomly assigned to receive a message promoting MJ abstinence or harm reduction. Regression analyses adjusting for MJ use, alcohol use, and age determined the effects of the message and reactance on individuals' attitudes, MJ craving, and intent to comply. Follow-up analyses determined the significant reactance subscales.  Results : The abstinence message evoked greater reactance than the harm reduction message and led to less favorable attitudes toward the advocated behavior. Across messages, reactance (specifically negative cognitive appraisal) was related to less favorable attitudes toward the advocated behavior and the study, as well as lower intent to comply. Additionally, reactance (specifically anger) was associated with greater self-reported craving.  Conclusions/Importance : Anti-MJ messages designed to discourage use might heighten reactance and inadvertently lead to greater craving and intent to use. The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.",2019,The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.,['Methods : College students and community members ( n \u2009=\u2009388) participated in an online study'],"[' ', 'message promoting MJ abstinence or harm reduction', 'Messaging and Psychological Reactance']",['Marijuana Craving'],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",388.0,0.0163103,The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.,"[{'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Slavin', 'Affiliation': 'University at Albany, State University of New York, Albany, NY, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Earleywine', 'Affiliation': 'University at Albany, State University of New York, Albany, NY, USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1650771']
684,31097414,Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial.,"BACKGROUND


Little is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG).
METHODS


We did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed.
FINDINGS


35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1·0 [95% CI 0·70-1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures.
INTERPRETATION


For patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.
FUNDING


UK Medical Research Council.",2019,"No adverse events were judged to be related to the study procedures.
","['primary care clinics in Ibadan, Nigeria', 'patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria', '1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6', 'primary care patients in Nigeria (STEPCARE', 'Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision', '35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group', 'Clinics (clusters), anonymised and stratified by local government area', 'Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9']","['mhGAP-IG', 'stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only', 'stepped-care intervention delivered by lay health workers', 'stepped-care intervention package']","['proportion of patients with remission of depression', 'psychotic illness', 'adverse events', 'bipolar disorder', 'remission of depression']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]",,0.115142,"No adverse events were judged to be related to the study procedures.
","[{'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. Electronic address: ogureje@comui.edu.ng.'}, {'ForeName': 'Bibilola D', 'Initials': 'BD', 'LastName': 'Oladeji', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': ""Nottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Bello', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Akin', 'Initials': 'A', 'LastName': 'Ojagbemi', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}]",The Lancet. Global health,['10.1016/S2214-109X(19)30148-2']
685,30844425,"Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


A 3-week short-course of adjuvant-free hydrolysates of Lolium perenne peptide (LPP) immunotherapy for rhinoconjunctivitis with or without asthma over 4 physician visits is safe, well tolerated, and effective.
OBJECTIVE


We sought to investigate immunologic mechanisms of LPP immunotherapy in a subset of patients who participated in a phase III, multicenter, randomized, double-blind, placebo-controlled trial (clinical.govNCT02560948).
METHODS


Participants were randomized to receive LPP (n = 21) or placebo (n = 11) for 3 weeks over 4 visits. Grass pollen-induced basophil, T-cell, and B-cell responses were evaluated before treatment (visit [V] 2), at the end of treatment (V6), and after the pollen season (V8).
RESULTS


Combined symptom and rescue medication scores (CSMS) were lower during the peak pollen season (-35.1%, P = .03) and throughout the pollen season (-53.7%, P = .03) in the LPP-treated group compared with those in the placebo-treated group. Proportions of CD63 +  and CD203c bright CRTH2 +  basophils were decreased following LPP treatment at V6 (10 ng/mL, P < .0001) and V8 (10 ng/mL, P < .001) compared to V2. No change in the placebo-treated group was observed. Blunting of seasonal increases in levels of grass pollen-specific IgE was observed in LPP-treated but not placebo-treated group. LPP immunotherapy, but not placebo, was associated with a reduction in proportions of IL-4 +  T H 2 (V6, P = .02), IL-4 +  (V6, P = .003; V8, P = .004), and IL-21 +  (V6, P = .003; V8, P = .002) follicular helper T cells. Induction of FoxP3 + , follicular regulatory T, and IL-10 +  regulatory B cells were observed at V6 (all P < .05) and V8 (all P < .05) in LPP-treated group. Induction of regulatory B cells was associated with allergen-neutralizing IgG 4 -blocking antibodies.
CONCLUSION


For the first time, we demonstrate that the immunologic mechanisms of LPP immunotherapy are underscored by immune modulation in the T- and B-cell compartments, which is necessary for its effect.",2019,Blunting of seasonal increases in levels of grass pollen-specific IgE was observed in LPP-treated but not placebo-treated group.,['Participants'],"['placebo', 'Lolium perenne peptide (LPP) immunotherapy', 'LPP', 'LPP immunotherapy', 'Lolium perenne peptide immunotherapy']","['Induction of FoxP3 + , follicular regulatory T, and IL-10 +  regulatory B cells', 'Grass pollen-induced basophil, T-cell, and B-cell responses', 'levels of grass pollen-specific IgE', 'Proportions of CD63 +  and CD203c bright CRTH2 +  basophils', 'rescue medication scores (CSMS']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0331558', 'cui_str': 'Lolium perenne (organism)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C3178914', 'cui_str': 'B-Cells, Regulatory'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1270900', 'cui_str': 'Grass pollen specific immunoglobulin E'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]",,0.544754,Blunting of seasonal increases in levels of grass pollen-specific IgE was observed in LPP-treated but not placebo-treated group.,"[{'ForeName': 'Hanisah', 'Initials': 'H', 'LastName': 'Sharif', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Iesha', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Kouser', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mösges', 'Affiliation': 'Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), Cologne, Germany.'}, {'ForeName': 'Marie-Alix', 'Initials': 'MA', 'LastName': 'Bonny', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Karamani', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Parkin', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bovy', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Kishore', 'Affiliation': 'Brunel University, Uxbridge, United Kingdom.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Robb', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Katotomichelakis', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Gabriële', 'Initials': 'G', 'LastName': 'Holtappels', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Derycke', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Corazza', 'Affiliation': 'Laboratory of Clinical Biology, CHU Brugmann, Brussels, Belgium.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'von Frenckell', 'Affiliation': 'Freelance Biostatistics Consultant, Waterloo, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Wathelet', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Duchateau', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Legon', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pirotton', 'Affiliation': 'ASIT Biotech S.A., Brussels, Belgium.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair & Development, Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, United Kingdom. Electronic address: m.shamji@imperial.ac.uk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.02.023']
686,31477558,Aspirin as an adjuvant treatment for cancer: feasibility results from the Add-Aspirin randomised trial.,"BACKGROUND


Preclinical, epidemiological, and randomised data indicate that aspirin might prevent tumour development and metastasis, leading to reduced cancer mortality, particularly for gastro-oesophageal and colorectal cancer. Randomised trials evaluating aspirin use after primary radical therapy are ongoing. We present the pre-planned feasibility analysis of the run-in phase of the Add-Aspirin trial to address concerns about toxicity, particularly bleeding after radical treatment for gastro-oesophageal cancer.
METHODS


The Add-Aspirin protocol includes four phase 3 randomised controlled trials evaluating the effect of daily aspirin on recurrence and survival after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer. An open-label run-in phase (aspirin 100 mg daily for 8 weeks) precedes double-blind randomisation (for participants aged under 75 years, aspirin 300 mg, aspirin 100 mg, or matched placebo in a 1:1:1 ratio; for patients aged 75 years or older, aspirin 100 mg or matched placebo in a 2:1 ratio). A preplanned analysis of feasibility, including recruitment rate, adherence, and toxicity was performed. The trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN74358648) and remains open to recruitment.
FINDINGS


After 2 years of recruitment (October, 2015, to October, 2017), 3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts. End of run-in data were available for 2253 patients; 2148 (95%) of the participants took six or seven tablets per week. 11 (0·5%) of the 2253 participants reported grade 3 toxicity during the run-in period, with no upper gastrointestinal bleeding (any grade) in the gastro-oesophageal cancer cohort. The most frequent grade 1-2 toxicity overall was dyspepsia (246 [11%] of 2253 participants).
INTERPRETATION


Aspirin is well-tolerated after radical cancer therapy. Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts. Trial recruitment continues to determine whether aspirin could offer a potential low cost and well tolerated therapy to improve cancer outcomes.
FUNDING


Cancer Research UK, The National Institute for Health Research Health Technology Assessment Programme, The MRC Clinical Trials Unit at UCL.",2019,"Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts.","['gastro-oesophageal cancer', '11', '3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts', '2253 patients; 2148 (95%) of the participants took six or seven tablets per week', 'patients aged 75 years or older', 'cancer', 'after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer']","['aspirin', 'Aspirin', 'aspirin 100 mg or matched placebo', 'open-label run-in phase (aspirin', 'aspirin 300 mg, aspirin 100 mg, or matched placebo']","['grade 3 toxicity', 'recruitment rate, adherence, and toxicity', 'adherence, acceptance of randomisation, or toxicity', 'recurrence and survival']","[{'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0303407', 'cui_str': 'In-115 radioisotope'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0983862', 'cui_str': 'Aspirin 300 MG'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",2253.0,0.432177,"Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts.","[{'ForeName': 'Nalinie', 'Initials': 'N', 'LastName': 'Joharatnam-Hogan', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Cafferty', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hubner', 'Affiliation': 'The Christie Hospital, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Swinson', 'Affiliation': 'St James University Hospital, Leeds, UK.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry and Warwickshire, UK.'}, {'ForeName': 'Kamalnayan', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Worcestershire Royal Hospital, Worcester, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Warner', 'Affiliation': 'Stoke Mandeville Hospital, Aylesbury, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kunene', 'Affiliation': 'Manor Hospital, Walsall, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Komel', 'Initials': 'K', 'LastName': 'Khabra', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Underwood', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Jankowski', 'Affiliation': 'Gastroenterology Unit, Morecambe Bay University Hospitals NHS Trust, UK; National Institute for Health and Care Excellence, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College Hospital London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Crossley', 'Affiliation': 'St James University Hospital, Leeds, UK.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Henson', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Berkman', 'Affiliation': 'NCRI Consumer Liaison Group, London, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Gilbert', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Ring', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Cancer Research UK Edinburgh Centre, MRC Institute of Genetics & Molecular Medicine, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Din', 'Affiliation': 'Cancer Research UK Edinburgh Centre, MRC Institute of Genetics & Molecular Medicine, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Southampton General Hospital, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pramesh', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK. Electronic address: ruth.langley@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30289-4']
687,31764361,Wound-Healing Following Negative-Pressure Wound Therapy with Use of a Locally Developed AquaVac System as Compared with the Vacuum-Assisted Closure (VAC) System.,"BACKGROUND


Negative-pressure wound therapy (NPWT) gained widespread clinical use after its introduction in the 1990s because of its many beneficial effects on the wound environment. However, high treatment costs have limited its use in third-world countries. The present study compares a low-cost, locally developed NPWT system with a commercially available system in terms of efficacy, reliability, ease of application, and safety.
METHODS


This prospective, randomized controlled trial involved 36 patients who were managed with NPWT with either a low-cost, locally developed system (AquaVac) or a commercially available Vacuum-Assisted Closure Advanced Therapy System (VAC ATS; KCI). The low-cost NPWT system described consists of a converted aquarium pump as a reusable vacuum source and a dressing system that can be found in the hospital supply room: food plastic wrap as an occlusive drape, surgical gauze as wound filler, nasogastric tubes as tubing, and used intravenous (IV) bottles as effluent canisters. The purpose of the study was to compare the 2 systems in terms of (1) time to apply the dressing, (2) exudate levels, (3) amount of granulation tissue, (4) wound size reduction, (5) average cost of treatment, (6) visual analog scale (VAS) pain scores, and (7) complications.
RESULTS


The experimental low-cost system had a small but statistically insignificant advantage over the commercially available system in terms of application time, pain during dressing changes, and wound contraction percentage. The 2 systems were comparable in terms of the amount of exudate, granulation tissue coverage, and VAS scores during the course of treatment. No wound or periwound complications were observed. The systems were significantly different in terms of cost, with the AquaVac system being 7 times less expensive than the VAC ATS system ($63.75 compared with $491.38 USD).
CONCLUSIONS


The low-cost AquaVac system was shown to be comparable with the commercial VAC ATS system, suggesting that it is an effective and safe alternative method for NPWT in resource-challenged settings.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"The experimental low-cost system had a small but statistically insignificant advantage over the commercially available system in terms of application time, pain during dressing changes, and wound contraction percentage.","['36 patients who were managed with NPWT with either a low-cost, locally developed system (AquaVac) or a']","['commercially available Vacuum-Assisted Closure Advanced Therapy System (VAC ATS; KCI', 'Negative-pressure wound therapy (NPWT', 'Vacuum-Assisted Closure (VAC) System', 'Negative-Pressure Wound Therapy with Use of a Locally Developed AquaVac System']","['No wound or periwound complications', 'efficacy, reliability, ease of application, and safety', '1) time to apply the dressing, (2) exudate levels, (3) amount of granulation tissue, (4) wound size reduction, (5) average cost of treatment, (6) visual analog scale (VAS) pain scores, and (7) complications', 'amount of exudate, granulation tissue coverage, and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956080', 'cui_str': 'Vacuum-Assisted Closure'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018180', 'cui_str': 'Granulation Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C2586310', 'cui_str': 'Amount of exudate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0338337,"The experimental low-cost system had a small but statistically insignificant advantage over the commercially available system in terms of application time, pain during dressing changes, and wound contraction percentage.","[{'ForeName': 'Hansel Gould B', 'Initials': 'HGB', 'LastName': 'Cocjin', 'Affiliation': 'Department of Orthopaedics & Traumatology, Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH), Bacolod City, Philippines.'}, {'ForeName': 'Jair Kimri P', 'Initials': 'JKP', 'LastName': 'Jingco', 'Affiliation': 'Department of Orthopaedics & Traumatology, Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH), Bacolod City, Philippines.'}, {'ForeName': 'Franklin Delano C', 'Initials': 'FDC', 'LastName': 'Tumaneng', 'Affiliation': 'Department of Orthopaedics & Traumatology, Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH), Bacolod City, Philippines.'}, {'ForeName': 'Jose Maria R', 'Initials': 'JMR', 'LastName': 'Coruña', 'Affiliation': 'Department of Orthopaedics & Traumatology, Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH), Bacolod City, Philippines.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00125']
688,31764363,"The Effects of Perioperative Corticosteroids on Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine: A Prospective, Randomized, Controlled, Double-Blinded Clinical Trial.","BACKGROUND


Dysphagia is one of the most common complications of surgical procedures in the anterior cervical spine, and can persist up to 2 years postoperatively. Corticosteroids are relatively safe and inexpensive for treating various inflammatory conditions. Perioperative corticosteroid administration for anterior cervical spine procedures may effectively minimize postoperative dysphagia, potentially leading to better outcomes, decreased readmission rates, and improved patient satisfaction. The purpose of this study was to determine the efficacy of perioperative corticosteroids in decreasing the severity and duration of dysphagia following single-level and multilevel anterior cervical spine procedures.
METHODS


Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited. Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded. Patients were randomized to perioperative intravenous dexamethasone or saline solution. Doses were administered before incision and at 8 and 16 hours postoperatively. Investigators and patients were blinded to the treatment throughout the study. Dysphagia outcomes were assessed with use of the Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ) at 1 day, 2 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months postoperatively. Statistical analysis was performed comparing means and standard deviations; significance was set at p < 0.05. Clinical outcomes were measured with use of the Quality of Life-12 and Neck Disability Index.
RESULTS


Sixty-four patients were included in the analysis. There were 49 anterior cervical discectomies and fusions, 8 corpectomies, 1 hybrid procedure (corpectomy and adjacent discectomy), and 6 single-level arthroplasties. Patients who received corticosteroids had significantly better dysphagia scores on both the Bazaz scale and DSQ at most time points up to 6 months postoperatively (p < 0.05). On subgroup analysis, patients with multilevel (≥2-level) fusion benefited significantly from corticosteroids on both scales, whereas those with single-level procedures did not. There were no short-term wound complications or infections, and length of stay and fusion rates were comparable.
CONCLUSIONS


Perioperative administration of corticosteroids can reduce dysphagia symptoms following multilevel anterior cervical procedures. Benefit was noted immediately and up to 6 months postoperatively. There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","['Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine', 'Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited', 'multilevel anterior cervical procedures', 'Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded', 'Sixty-four patients were included in the analysis']","['Perioperative Corticosteroids', 'corticosteroids', 'Corticosteroids', 'perioperative intravenous dexamethasone or saline solution', 'perioperative corticosteroids']","['Quality of Life-12 and Neck Disability Index', 'dysphagia scores', 'dysphagia symptoms', 'Dysphagia outcomes', 'Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ', 'Bazaz scale and DSQ', 'short-term wound-healing, infection rates, length of stay, or fusion rates', 'short-term wound complications or infections, and length of stay and fusion rates', 'readmission rates']","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0034380'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",49.0,0.0837887,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","[{'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Daffner', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'France', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Sanford E', 'Initials': 'SE', 'LastName': 'Emery', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00198']
689,31764368,Effect of Training Modules on Hip Fracture Surgical Skills Simulation Performance: Early Validation of the AAOS/OTA Simulator.,"BACKGROUND


A preliminary validation study on a computer-based force-feedback simulation platform demonstrated the ability of the simulator to distinguish between novice and experienced users during a simulated hip-pinning procedure. The purpose of the present study was to further investigate whether the simulator and associated training modules are effective for improving user performance during simulated percutaneous hip-pinning procedures.
METHODS


With institutional review board approval, 24 medical students at our institution were randomized to ""Trained"" and ""Untrained"" groups. After a basic introduction, the Untrained group placed 3 guidewires in a valgus-impacted femoral neck fracture with use of the simulator. The Trained group completed 9 simulator-based training modules before performing the same task. Measured outcomes included an overall performance score and the distance from the pin to various ideals on the femoral neck, femoral head articular surface, and lateral cortex. Performance parameters were compared between groups with the Mann-Whitney U test.
RESULTS


The Trained group achieved a significantly higher overall score (median, 29) compared with the Untrained group (median, 6) (p < 0.01), outperformed the Untrained group in 4 specific performance metrics, and trended toward improvement over the Untrained group in 4 pin placement measures (p < 0.2).
CONCLUSIONS


Completion of novel training modules for percutaneous hip pinning on this fluoroscopic surgery simulator improves skill performance on simulator-based objective measurements and a simulated orthopaedic procedure compared with non-simulator-trained surgically inexperienced users. Improvement in the overall score and on 4 of 13 specific performance parameters implies that the training modules more effectively teach only certain motor and 3-dimensional spatial skills.
CLINICAL RELEVANCE


A valid platform such as the one described here has the potential to improve surgical education in orthopaedic trauma.",2019,"The Trained group achieved a significantly higher overall score (median, 29) compared with the Untrained group (median, 6) (p < 0.01), outperformed the Untrained group in 4 specific performance metrics, and trended toward improvement over the Untrained group in 4 pin placement measures (p < 0.2).
","['novice and experienced users during a simulated hip-pinning procedure', '24 medical students at our institution']",['Training Modules'],"['Hip Fracture', 'effectively teach only certain motor and 3-dimensional spatial skills', 'overall performance score and the distance from the pin to various ideals on the femoral neck, femoral head articular surface, and lateral cortex', 'overall score', 'skill performance']","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]",,0.0492156,"The Trained group achieved a significantly higher overall score (median, 29) compared with the Untrained group (median, 6) (p < 0.01), outperformed the Untrained group in 4 specific performance metrics, and trended toward improvement over the Untrained group in 4 pin placement measures (p < 0.2).
","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Domes', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': 'Institute for Foot and Ankle Reconstruction at Mercy, Mercy Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Coale', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cullen', 'Initials': 'C', 'LastName': 'Griffith', 'Affiliation': 'Orthopaedic Specialty Group, Fairfield, Connecticut.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'R Frank', 'Initials': 'RF', 'LastName': 'Henn', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Marcus F', 'Initials': 'MF', 'LastName': 'Sciadini', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00505']
690,32173255,Clinical observations of the effect of orthokeratology in children with myopic anisometropia.,"PURPOSE


To evaluate the clinical effect of orthokeratology in controlling myopia and treating anisometropia among children with myopic anisometropia.
METHODS


A total of 108 myopic anisometropic children aged 8-16 years old who wore orthokeratology lenses in both eyes were enrolled in this study and followed up for over 1 year. The more severely myopic eye of each patient was assigned to the more myopic group (108 eyes), with a mean spherical equivalent refraction of -4.25 (-5.00, -3.38) D; the opposite eye of each patient was assigned to the less myopic group (108 eyes), with a refraction of -2.75 (-3.63, -1.88) D. This study observed and analyzed changes in ocular parameters after orthokeratology (Wilcoxon signed-rank test).
RESULTS


In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005). The difference between the axial lengths of the two eyes significantly dropped from 0.54 (0.37, 0.74) mm to 0.46 (0.28, 0.67) mm (P< .0001).
CONCLUSIONS


Orthokeratology seemed to be more effective at delaying the progression of myopia in the more myopic eyes than in the less myopic eyes of myopic anisometropic children. Orthokeratology lenses are suitable for anisometropic children, although the effectiveness of orthokeratology against anisometropia requires additional follow-up time for further observation and study.",2020,"In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005).","['108 myopic anisometropic children aged 8-16 years old who wore orthokeratology lenses in both eyes', 'anisometropic children', 'children with myopic anisometropia']",['Orthokeratology lenses'],"['level of anisometropia', 'axial lengths']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",108.0,0.0403991,"In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005).","[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'School of Ophthalmology and Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, Zhejiang, 325027, China.'}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': 'School of Ophthalmology and Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, Zhejiang, 325027, China. Electronic address: wcyjqw@163.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.002']
691,31033900,Eccentric and Concentric Resistance Exercise Comparison for Knee Osteoarthritis.,"INTRODUCTION


This study aimed to compare the efficacy of eccentrically focused resistance exercise (ECC RT) to concentrically focused resistance exercise (CNC RT) on knee osteoarthritis (OA) symptoms and strength.
METHODS


Ninety participants consented. Participants were randomized to CNC RT, ECC RT, or a wait-list, no-exercise control group. Four months of supervised exercise training was completed using traditional weight machines (CNC RT) or modified-matched machines that overloaded the eccentric action (ECC RT). Main outcomes included one-repetition maximal strength (knee extension, leg flexion, and leg press), weekly rate of strength gain, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score and subscores.
RESULTS


Fifty-four participants (60-85 yr, 61% women) completed the study. Both CNC RT and ECC RT groups showed 16%-28% improvement relative to the wait-list, no-exercise control group (P = 0.003-0.005) for all leg strength measures. The rate of weekly strength gain was greater for CNC RT than for ECC RT for leg press and knee flexion (by 2.9%-4.8%; both, P < 0.05) but not knee extension (0.7%; P = 0.38). There were no significant differences in WOMAC total and subscores across groups over time. Leg press strength change was the greatest contributor to change in WOMAC total scores (R = 0.223). The change in knee flexion strength from baseline to month 4 was a significant predictor of the change in WOMAC pain subscore (F ratio = 4.84, df = 45, P = 0.032). Both modes of strength training were well tolerated.
CONCLUSIONS


Both resistance training types effectively increased leg strength. Knee flexion and knee extension muscle strength can modify function and pain symptoms irrespective of muscle contraction type. Which mode to pick could be determined by preference, goals, tolerance to the contraction type, and equipment availability.",2019,Both CNC RT and ECC RT groups showed 16%-28% improvement relative to CON group (p = 0.003 to 0.005) for all leg strength measures.,"['Knee Osteoarthritis', '54 participants (60-85yr, 61% women) completed the study', '90 participants consented']","['CON', 'Knee flexion and knee extension muscle strength', 'strength training', 'supervised exercise training', 'CNC RT and ECC RT', 'Eccentric and Concentric Resistance Exercise Comparison', 'traditional weight machines (CNC RT), or modified-matched machines that overloaded the eccentric action (ECC RT', 'eccentrically-focused resistance exercise (ECC RT) to concentrically-focused resistance exercise (CNC RT', 'CNC RT, ECC RT or a wait-list no-exercise control group (CON']","['rate of weekly strength gain', 'WOMAC total and sub-scores', 'tolerated', 'WOMAC pain sub-score', 'leg press and knee flexion', 'repetition maximal strength (1RM; knee extension, leg flexion and leg press), weekly rate of strength gain, Western Ontario McMaster University Osteoarthritis Index (WOMAC) total score and sub-scores', 'WOMAC Total scores', 'knee osteoarthritis (OA) symptoms and strength', 'leg strength', 'knee flexion strength']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0237648,Both CNC RT and ECC RT groups showed 16%-28% improvement relative to CON group (p = 0.003 to 0.005) for all leg strength measures.,"[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Vincent', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Vasilopoulos', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Montero', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, College of Medicine, University of Florida, Gainesville, FL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002010']
692,31033901,Effect of a Ketogenic Diet on Submaximal Exercise Capacity and Efficiency in Runners.,"PURPOSE


We investigated the effect of a 31-d ketogenic diet (KD) on submaximal exercise capacity and efficiency.
METHODS


A randomized, repeated-measures, crossover study was conducted in eight trained male endurance athletes (V˙O2max, 59.4 ± 5.2 mL⋅kg⋅min). Participants ingested their habitual diet (HD) (13.1 MJ, 43% [4.6 g⋅kg⋅d] carbohydrate and 38% [1.8 g⋅kg⋅d] fat) or an isoenergetic KD (13.7 MJ, 4% [0.5 g·kg⋅d] carbohydrate and 78% [4 g⋅kg⋅d] fat) from days 0 to 31 (P < 0.001). Participants performed a fasted metabolic test on days -2 and 29 (~25 min) and a run-to-exhaustion trial at 70% V˙O2max on days 0 and 31 following the ingestion of a high-carbohydrate meal (2 g⋅kg) or an isoenergetic low-carbohydrate, high-fat meal (<10 g CHO), with carbohydrate (~55 g⋅h) or isoenergetic fat (0 g CHO⋅h) supplementation during exercise.
RESULTS


Training loads were similar between trials and V˙O2max was unchanged (all, P > 0.05). The KD impaired exercise efficiency, particularly at >70% V˙O2max, as evidenced by increased energy expenditure and oxygen uptake that could not be explained by shifts in respiratory exchange ratio (RER) (all, P < 0.05). However, exercise efficiency was maintained on a KD when exercising at <60% V˙O2max (all, P > 0.05). Time-to-exhaustion (TTE) was similar for each dietary adaptation (pre-HD, 237 ± 44 vs post-HD, 231 ± 35 min; P = 0.44 and pre-KD, 239 ± 27 vs post-KD, 219 ± 53 min; P = 0.36). Following keto-adaptation, RER >1.0 vs <1.0 at V˙O2max coincided with the preservation and reduction in TTE, respectively.
CONCLUSION


A 31-d KD preserved mean submaximal exercise capacity in trained endurance athletes without necessitating acute carbohydrate fuelling strategies. However, there was a greater risk of an endurance decrement at an individual level.",2019,"The KD impaired exercise efficiency, particularly at >70%","['trained endurance athletes', 'eight trained male endurance athletes (maximal oxygen uptake ', 'Runners']","['Ketogenic Diet', '31-d ketogenic diet (KD', 'V[Combining', 'Dot Above]O2max (~12.9 km⋅h) after the ingestion of a high-carbohydrate meal (2 g⋅kg) or an isoenergetic low-carbohydrate, high-fat meal, with carbohydrate (~55 g⋅h) or isoenergetic fat (coconut oil) supplementation']","['time-to-exhaustion', 'exercise efficiency', 'submaximal exercise capacity', 'energy expenditure', 'Submaximal Exercise Capacity and Efficiency', 'KD impaired exercise efficiency', 'submaximal exercise capacity and efficiency']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}]",8.0,0.0711329,"The KD impaired exercise efficiency, particularly at >70%","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shaw', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, NEW ZEALAND.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Merien', 'Affiliation': 'AUT-Roche Diagnostics Laboratory, School of Science, Auckland University of Technology, Auckland, NEW ZEALAND.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Braakhuis', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, NEW ZEALAND.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Maunder', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, NEW ZEALAND.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Dulson', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, NEW ZEALAND.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002008']
693,31058762,The Impact of Morning versus Afternoon Exercise on Iron Absorption in Athletes.,"PURPOSE


This study examined postexercise inflammatory, hepcidin, and iron absorption responses to endurance exercise performed in the morning versus the afternoon.
METHODS


Sixteen endurance-trained runners (10 male, 6 female) with serum ferritin (sFer) < 50 μg·L completed a 90-min running protocol (65% vV˙O2max) in the morning (AM), or the afternoon (PM), in a crossover design. An iron-fortified fluid labeled with stable iron isotopes (Fe or Fe) was administered with a standardized meal 30 min following the exercise and control conditions during each trial, serving as a breakfast and dinner meal. Venous blood samples were collected before, immediately after, and 3 h after the exercise and control conditions to measure sFer, serum interleukin-6 (IL-6), and serum hepcidin-25. A final venous blood sample was collected 14 d after each trial to determine the erythrocyte iron incorporation, which was used to calculate iron absorption. Linear mixed-modeling was used to analyze the data.
RESULTS


Overall, exercise significantly increased the concentrations of IL-6 (4.938 pg·mL; P = 0.006), and hepcidin-25 concentrations significantly increased 3 h after exercise by 0.380 nM (P < 0.001). During the PM trial, hepcidin concentrations exhibited diurnal tendency, increasing 0.55 nM at rest (P = 0.007), before further increasing 0.68 nM (P < 0.001) from prerun to 3 h postrun. Fractional iron absorption was significantly greater at breakfast after the AM run, compared with both the rested condition (0.778%; P = 0.020) and dinner in the AM run trial (0.672%; P = 0.011).
CONCLUSIONS


Although exercise resulted in increased concentrations of IL-6 and hepcidin, iron was best absorbed in the morning after exercise, indicating there may be a transient mechanism during the acute postexercise window to promote iron absorption opposing the homeostatic regulation by serum hepcidin elevations.",2019,"Overall, exercise significantly increased the concentrations of IL-6 (4.938 pg⋅mL; p=0.006), and Hepcidin-25 concentrations significantly increased 3 h following exercise by 0.380 nM (p<0.001).","['Athletes', 'Sixteen endurance-trained runners (10 male, 6 female) with serum ferritin (sFer']","['iron-fortified fluid labelled with stable iron isotopes (Fe or Fe', 'Morning versus Afternoon Exercise']","['sFer, serum interleukin-6 (IL-6), and serum hepcidin-25', 'concentrations of IL-6', 'Fractional iron absorption', 'concentrations of IL-6 and hepcidin', 'Venous blood samples', 'Hepcidin-25 concentrations']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022089', 'cui_str': 'Iron Isotopes'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.0579107,"Overall, exercise significantly increased the concentrations of IL-6 (4.938 pg⋅mL; p=0.006), and Hepcidin-25 concentrations significantly increased 3 h following exercise by 0.380 nM (p<0.001).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McCormick', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moretti', 'Affiliation': 'Laboratory of Human Nutrition, Department of Health Sciences and Technology, ETH Zürich, SWITZERLAND.'}, {'ForeName': 'Alannah K A', 'Initials': 'AKA', 'LastName': 'McKay', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}, {'ForeName': 'Coby M', 'Initials': 'CM', 'LastName': 'Laarakkers', 'Affiliation': 'Translational Metabolic Laboratory, Radboud University Medical Centre, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Vanswelm', 'Affiliation': 'Translational Metabolic Laboratory, Radboud University Medical Centre, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Trinder', 'Affiliation': 'Medical School, Fiona Stanley Hospital, University of Western Australia, Murdoch, Western Australia, AUSTRALIA.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Cox', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, AUSTRALIA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'Laboratory of Human Nutrition, Department of Health Sciences and Technology, ETH Zürich, SWITZERLAND.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AUSTRALIA.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Goodman', 'Affiliation': 'The Western Australian Institute of Sport, Mt Claremont, Western Australia, AUSTRALIA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dawson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peeling', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002026']
694,30821168,"Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa.","HIV-infected women who have experienced sexual violence face unique challenges in their HIV care engagement and adherence to antiretroviral medications (ARVs). Improving AIDS Care after Trauma (ImpACT) is a brief counseling intervention aimed at reducing the negative impact of sexual trauma and HIV, building coping skills, and improving long-term HIV care engagement. We conducted a randomized controlled pilot trial of ImpACT with 64 women initiating ARVs in Cape Town, South Africa, with results suggesting the intervention can reduce PTSD symptoms and increase motivation to adhere to ARVs. For the current study, we abstracted data from ImpACT worksheets completed by 31 participants during intervention sessions, and qualitative responses from post-intervention surveys, to examine mechanisms, facilitators, and barriers to change in the intervention. Data included participant descriptions of the values informing their care, barriers to participation, and perceived benefits of the intervention related to coping with trauma and improving care engagement. During the first session, women reported feelings of shame, sadness, and anger that led to social isolation, mistrust, and damaged relationships. Barriers to participation included work and school demands, issues with transportation, finances, and discomfort in talking about HIV and trauma, particularly in group sessions. Despite these challenges, several women stated they developed more positive thinking, felt more confident, and improved their interpersonal relationships. Participants also reported substantial positive impact on symptoms of sexual trauma and motivation to continue with long-term HIV care, and clearer understanding of barriers and facilitators to ARV adherence. ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting. The data also offer insights into strategies to strengthen the intervention, overcome barriers to participation, encourage the practical application of skills, and promote long-term HIV care engagement.",2019,"ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting.","['64 women initiating ARVs in Cape Town, South Africa', 'HIV-infected women who have experienced sexual violence', 'Cape Town, South Africa', 'women with a history of trauma in this high-risk setting']",[],"['symptoms of sexual trauma and motivation to continue with long-term HIV care', 'coping with trauma and improving care engagement', 'PTSD symptoms and increase motivation to adhere to ARVs', 'feelings of shame, sadness, and anger that led to social isolation, mistrust, and damaged relationships']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation (finding)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]",64.0,0.0470416,"ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Knettel', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Knippler', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Nonceba', 'Initials': 'N', 'LastName': 'Ciya', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'Corné', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Sikkema', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}]",AIDS care,['10.1080/09540121.2019.1587368']
695,32171061,"MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.","BACKGROUND


Treatment of multiple myeloma is not curative, but targeting CD38 improves patient survival. To further explore this therapeutic approach, we investigated the safety and activity of MOR202, a novel monoclonal antibody targeting CD38, in patients with multiple myeloma.
METHODS


This is a multicentre, open-label, phase 1-2a trial done at ten hospitals in Germany and Austria. Enrolled patients were aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity. The primary analysis was assessed in the safety population, which included patients who received at least one dose of any study drug. This trial is registered with ClinicalTrials.gov, NCT01421186.
FINDINGS


Between Aug 24, 2011, and Aug 1, 2017, 91 patients were treated, 35 with MOR202 monotherapy, and 56 with MOR202 combination regimens (18 in the MOR202 with dexamethasone group, 21 in the MOR202 with dexamethasone plus pomalidomide group, and 17 in the MOR202 with dexamethasone plus lenalidomide group). MOR202 intravenous infusions were safely administered within 30 min. Infusion-related reactions occurred in 14 (40%) of 35 patients receiving MOR202 monotherapy without steroids, and in four (7%) of 56 patients receiving MOR202 combination treatment. MOR202 maximum tolerated dose was not reached and the recommended regimens were MOR202 administered as an intravenous infusion for 30 min at doses up to 16 mg/kg with dexamethasone (40 mg), or in combination with dexamethasone plus lenalidomide (25 mg) or pomalidomide (4 mg). 35 (38%) of 91 patients developed lymphopenia, 30 (33%) developed neutropenia, and 27 (30%) developed leukopenia; these were the most common grade 3 or higher treatment-emergent adverse events. Serious adverse events were reported in 51 (56%) of 91 patients. None of the deaths were associated with MOR202. One pomalidomide-associated death occurred in the MOR202 with dexamethasone plus pomalidomide group. No anti-MOR202 antibodies were detected in patients.
INTERPRETATION


MOR202 is safe and its clinical activity in patients with relapsed or refractory multiple myeloma is promising. Further clinical investigations of combinations with an immunomodulatory drug and dexamethasone are recommended.
FUNDING


MorphoSys AG.",2020,Serious adverse events were reported in 51 (56%) of 91 patients.,"['91 patients were treated, 35 with MOR202 monotherapy, and 56 with MOR202 combination regimens (18 in the MOR202 with dexamethasone group, 21 in the MOR202 with', 'Between Aug 24, 2011, and Aug 1, 2017', 'ten hospitals in Germany and Austria', 'patients with relapsed or refractory multiple myeloma', 'patients with multiple myeloma', 'Enrolled patients were aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher']","['MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone', 'MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3\u2008+\u20083 design', 'dexamethasone plus lenalidomide', 'MOR202 intravenous infusions alone', 'dexamethasone', 'dexamethasone plus lenalidomide (25 mg) or pomalidomide', 'MOR202', 'dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide', 'dexamethasone plus pomalidomide']","['No anti-MOR202 antibodies', 'Serious adverse events', 'neutropenia', 'safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity', 'death', 'lymphopenia', 'leukopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",91.0,0.152029,Serious adverse events were reported in 51 (56%) of 91 patients.,"[{'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany. Electronic address: marc.raab@med.uni-heidelberg.de.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Hematology and Oncology Department, Medical University Hospital, Freiburg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Hermine', 'Initials': 'H', 'LastName': 'Agis', 'Affiliation': 'Department of Medicine I, University Hospital of Internal Medicine -Allgemeines Krankenhaus Wien, Vienna, Austria.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Department of Internal Medicine III, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ferstl', 'Affiliation': 'Department of Internal Medicine 5, Hematology and Oncology, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Schub', 'Affiliation': 'Department of Medicine, University Hospital Schleswig-Holstein, Division of Stem Cell Transplantation and Immunotherapy, Kiel, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Department of Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg; Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Winderlich', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Griese', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Härtle', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weirather', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Tiantom', 'Initials': 'T', 'LastName': 'Jarutat', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Peschel', 'Affiliation': 'Department of Internal Medicine III, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Manik', 'Initials': 'M', 'LastName': 'Chatterjee', 'Affiliation': 'Translational Oncology, Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg, Würzburg, Germany.'}]",The Lancet. Haematology,['10.1016/S2352-3026(19)30249-2']
696,31566680,Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.,"Importance


A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit.
Objective


To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone.
Design, Setting, and Participants


In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on on May 12, 2019.
Interventions


The adjuvant chemotherapy regimen was selected by the treating physician.
Main Outcomes and Measures


Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]).
Results


Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
Conclusions and Relevance


The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population.
Trial Registration


ClinicalTrials.gov identifier NCT00310180.",2019,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","['1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100', 'women with a high RS who received', 'Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100', '9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100']","['cyclophosphamide/methotrexate/5-fluorouracil', 'taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy', 'endocrine therapy alone', 'adjuvant chemotherapy in addition to endocrine therapy', 'anthracycline without a taxane', 'docetaxel/cyclophosphamide', 'adjuvant chemotherapy plus endocrine therapy', 'anthracycline and taxane', 'Adjuvant Chemotherapy Plus Endocrine Therapy']","['Measures\n\n\nFreedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS', 'estimated rate of freedom from recurrence of breast cancer', 'freedom of recurrence of breast cancer', 'overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1389.0,0.21629,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Saphner', 'Affiliation': 'Aurora Cancer Center (formerly Vince Lombardi Cancer Clinic), Two Rivers, Wisconsin.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Badve', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Maccon M', 'Initials': 'MM', 'LastName': 'Keane', 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'Pavan S', 'Initials': 'PS', 'LastName': 'Reddy', 'Affiliation': 'Cancer Center of Kansas, Wichita, Kansas.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Goggins', 'Affiliation': 'Fox Valley Hematology and Oncology, Appleton, Wisconsin.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, Hawaii.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Mahalcioiu', 'Affiliation': 'McGill University, Montreal, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Desbiens', 'Affiliation': 'Universite Laval, Quebec, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'the Massey Cancer Center, Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Wood', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lively', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NSABP Pathology Office, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Indiana University Hospital, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4794']
697,32172314,Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,"PURPOSE


Drainage is a common procedure in high tibial osteotomy (HTO), but the benefits of drainage during HTO remain poorly investigated. This study was designed to investigate the effect of drainage on blood loss and early functional recovery in HTO.
METHODS


Altogether, 80 patients undergoing HTO were analyzed from August 2018 to September 2019. Patients were randomized into two groups: group A (drainage, n = 40) and group B (no drainage, n = 40). There were no intergroup differences in baseline parameters between the two groups, and the same surgical techniques and haemostatic methods were used. The mean follow-up time was 3.2 months. Blood loss and early functional recovery of the knee were examined post-operatively in both groups.
RESULTS


The total post-operative blood loss was 253.34 ± 104.18 ml in group A and 222.51 ± 106.89 ml in group B. This difference was non-significant (p > 0.05). The post-operative haemoglobin and haematocrit differences between groups were also non-significant (p > 0.05). Post-operative visual analogue scale (VAS) pain scores and lower leg swelling were lower in group A than those in group B (p < 0.05), and the early range of motion of the knee joint was higher in group A than that in group B (p < 0.05). Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05). The differences in three month post-operative VAS and knee function scores were non-significant (p > 0.05).
CONCLUSION


Drainage in HTO does not increase patients' total blood loss, but it can promote early knee function recovery by reducing post-operative pain, lower leg swelling, and the incidence of incision complications.
TRIAL REGISTRATION


NCT-03954860.",2020,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"['high tibial osteotomy (HTO', 'high tibial osteotomy', '80 patients undergoing HTO were analyzed from August 2018 to September 2019']",[],"['operative VAS and knee function scores', 'Post-operative visual analogue scale (VAS) pain scores and lower leg swelling', 'early range of motion of the knee joint', 'total blood loss', 'blood loss and early functional recovery', 'incidence rates of dressing seepage and incision complications', 'Drainage relieves pain', 'total post-operative blood loss', 'Blood loss and early functional recovery of the knee']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",80.0,0.0708681,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"[{'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Laoling Hospital of traditional Chinese Medicine, Dezhou, Shandong, China.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'Shandong University Cheeloo College of Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Qunshan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Desu', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Peilai', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China. 15634057227@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04530-z']
698,32169314,"Reply to Wei Liu, Xiaoping Liu, Sheng Li's Letter to the Editor, re: Robert A. Huddart, Emma Hall, Rebecca Lewis, et al. Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial. Eur Urol 2020;77:260-8.",,2020,,['Patients Treated for Muscle-invasive Bladder Cancer with'],['Radiotherapy ± Chemotherapy'],['Quality of Life Outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[{'cui': 'C0034380'}],,0.0777941,,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: robert.huddart@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Academic Unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer Research, London, UK; University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",European urology,['10.1016/j.eururo.2020.02.013']
699,32163323,Examining the Causal Effects of Sleep Deprivation on Emotion Regulation and Its Neural Mechanisms.,"Cognitive reappraisal (CR) is a strategy used to regulate emotions that is thought to be effective but effortful, relying on higherorder cognitive control systems to engage in active regulation. Sleep deprivation is believed to impair the functioning of these control systems, suggesting that it may impede the ability to implement CR effectively. This study tested the causal effects of sleep deprivation on emotional reactivity and the neurobiological systems underlying CR. We employed a within-subject crossover design in which participants underwent fMRI scanning twice, once when fully rested and once after a night of total sleep deprivation. During scans, participants passively viewed or used CR to downregulate their emotional response to negative and neutral images. Contrary to hypotheses, both self-reported negative affect ratings and neural responses to the images indicated no difference in the way participants implemented CR when sleep deprived and when fully rested. Meanwhile, neural regions that showed distinct reactivity responses to negative relative to neutral images lost this specificity under deprived conditions. Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting. Together, these results suggest that, although sleep deprivation may reduce the discrimination between emotional reactivity responses to negative and neutral stimuli, it does not impact CR the way it is presently studied.",2020,"Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting.",[],"['Cognitive reappraisal (CR', 'fMRI scanning']",['Negative affect ratings and heart rate deceleration'],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}]",,0.0247213,"Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting.","[{'ForeName': 'Maheen', 'Initials': 'M', 'LastName': 'Shermohammed', 'Affiliation': 'Harvard University.'}, {'ForeName': 'Laurel E', 'Initials': 'LE', 'LastName': 'Kordyban', 'Affiliation': 'Harvard University.'}, {'ForeName': 'Leah H', 'Initials': 'LH', 'LastName': 'Somerville', 'Affiliation': 'Harvard University.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01555']
700,32170551,SERPINE-1 Gene Methylation and Protein as Molecular Predictors of Laparoscopic Sleeve Gastrectomy Outcome.,"BACKGROUND


Body weight is subjected to genetic and epigenetic modifiers that might affect the success of weight loss interventions. Because of its possible complications and disparity in patients' response, identification of predictors to the outcome of bariatric surgery is indispensable.
OBJECTIVES


This prospective study aims to investigate serpin peptidase inhibitor type 1 (SERPINE-1) protein and gene methylation as molecular predictors to the outcome of bariatric surgery.
PATIENTS AND METHODS


One hundred participants were enrolled and divided to control group (n = 50) and obese patients who underwent laparoscopic sleeve gastrectomy (LSG) (n = 50). Anthropometric measurements were assessed and blood samples were collected preoperatively and 6 months postoperatively for assessment of SERPINE-1 protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR). Moreover, subjects were followed for 2 years for weight loss parameters.
RESULTS


Patients with obesity showed high baseline SERPINE-1 protein and gene hypermethylation where LSG was followed by a drop in SERPINE-1 protein level but not gene hypermethylation. Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG. Likewise, postoperative SERPINE-1 protein was negatively related to weight loss with independent expression from its gene methylation state. Furthermore, postoperative SERPINE-1 gene methylation correlated to CRP and HOMA-IR.
CONCLUSION


Baseline SERPINE-1 gene methylation might be a predictor of weight loss after LSG. Meanwhile, postoperative SERPINE-1 protein could be a predictor to weight loss maintenance after LSG. Lastly, postoperative SERPINE-1 gene methylation might serve as an index to postoperative changes in obesity-related comorbidities.",2020,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,['One hundred participants were enrolled and divided to control group (n\u2009=\u200950) and obese patients who underwent'],['laparoscopic sleeve gastrectomy (LSG'],"['weight loss', 'protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR', 'postoperative weight loss']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.0189398,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Assem', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Abdelbaki', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Safaa H', 'Initials': 'SH', 'LastName': 'Mohy-El Dine', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Amel F', 'Initials': 'AF', 'LastName': 'Ketat', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Abdelmonsif', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt. doaa.elmonsif@alexmed.edu.eg.'}]",Obesity surgery,['10.1007/s11695-020-04533-0']
701,32170552,The Prognostic Value of the Dutch Sweet Eating Questionnaire on Weight Loss After Metabolic Surgery: a Randomized Controlled Trial.,"BACKGROUND


Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) have shown different weight loss results. These differences might be partly due to dumping after LRYGB, forcing sweet eaters to switch to a healthy diet. The Dutch Sweet Eating Questionnaire (DSEQ) is validated to measure sweet eating. This study aims to investigate if sweet eating measured with the DSEQ influences weight loss.
METHODS


In this multicenter randomized controlled trial, patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG. Primary outcome measure was weight loss. Secondary outcome measure was sweet eating behavior, measured with the DSEQ. Data was collected at baseline, 1 year and 2 years postoperatively.
RESULTS


Data was analyzed of 623 patients who underwent LRYGB (n = 308; 49.4%) or LSG (n = 315; 50.6%). Follow-up rates at 2 years postoperative were 67.1% for weight and 35.3% for DSEQ. At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049). None of the preoperative sweet eaters were sweet eaters 2 years after LRYGB (0.0%), versus 11.8% 2 years after LSG. No correlation was found between postoperative sweet eating behavior and %EBMIL.
CONCLUSION


No significant correlation was found between preoperative or postoperative sweet eating measured with the DSEQ and weight loss. The decision-making for the procedure type is more complex than weight loss and dietary habits, and should also involve quality of life and presence of comorbidities. These factors should be addressed in future research along with longer term results.
TRIAL REGISTRATION


Dutch Trial Register NTR-4741.",2020,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","['patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG', '623 patients who underwent LRYGB (n\u2009=\u2009308; 49.4%) or']","['LSG', 'Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG']","['preoperative or postoperative sweet eating', 'weight loss', 'sweet eating behavior, measured with the DSEQ', 'DSEQ and weight loss', 'Weight Loss', 'postoperative sweet eating behavior and %EBMIL', 'mean BMI', 'percentage of sweet eaters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C3494218', 'cui_str': 'Hospitals, High-Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.124103,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","[{'ForeName': 'L U', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands. M.Leeman@Franciscus.nl.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Friskes', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'der Kinderen', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Zengerink', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Smulders', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-04527-y']
702,32163634,Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial.,"AIM


The aim of this study was to compare surgical treatment of periodontal intra-bony defects (IBD) with or without the adjunct of enamel matrix derivative (EMD) in terms of acute-phase responses in healthy patients.
METHODS


Thirty-eight periodontitis-affected subjects, one IDB each, were randomized to minimally invasive periodontal surgery (MIS) with or without EMD. Periodontal parameters were recorded at baseline and 6-months. Blood samples were collected at baseline, 1, 7 and 180 days after treatment.
RESULTS


At 24 hr, the group treated MIS with EMD showed lower values of C-reactive protein (CRP; p < .01) as no inflammatory perturbation was noticed. Conversely, MIS group resulted in an acute inflammatory response at 24 hr (p < .05) that regressed to its baseline values at day 7. The EMD group showed a higher number of cases without residual BOP or PPD ≥ 5mm 6 months after surgery (p < .05), and post-surgical gingival recession was lower (p < .05).
CONCLUSIONS


The adjunctive application of EMD during surgical treatment resulted in a minor increase in serum CRP 24-hr after surgery. These findings suggest a possible systemic anti-inflammatory effect of EMD. Within its limitations, this pilot trial confirmed better clinical periodontal outcomes in the EMD group. NCT03590093.",2020,The adjunctive application of EMD during surgical treatment resulted in a minor increase in serum CRP 24-hr after surgery.,"['periodontal regenerative surgery', 'healthy patients', 'Thirty-eight periodontitis-affected subjects, one IDB each']","['enamel matrix derivative', 'minimally invasive periodontal surgery (MIS) with or without EMD', 'periodontal intra-bony defects (IBD) with or without the adjunct of enamel matrix derivative (EMD']","['post-surgical gingival recession', 'Blood samples', 'acute inflammatory response', 'serum CRP 24-hr', 'residual BOP or PPD', 'lower values of C-reactive protein', 'Periodontal parameters', 'acute systemic inflammation']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0398950', 'cui_str': 'Periodontal operation (procedure)'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",38.0,0.101197,The adjunctive application of EMD during surgical treatment resulted in a minor increase in serum CRP 24-hr after surgery.,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Graziani', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Urska', 'Initials': 'U', 'LastName': 'Marhl', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bettini', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Tonetti', 'Affiliation': 'Faculty of Dentistry, University of Hong Kong, Hong Kong, SAR China.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gennai', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13270']
703,31309333,"Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG.","PURPOSE


To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up.
METHODS


Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days.
RESULTS


Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20-1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups.
CONCLUSIONS


No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.",2019,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"['Eighty-nine patients with CLBP and type 1 MC or mixed MC', 'chronic low back pain with type 1 Modic changes', 'chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up']","['lactic acid bacteria', 'capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100\xa0days', 'placebo', 'Probiotics']","['outcomes disability and back\u2009+\u2009leg pain', 'global effect or percentage with minimal disability', 'gastrointestinal side effects', 'back pain']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1210581', 'cui_str': 'Lactic Acid Bacteria'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",89.0,0.459244,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"[{'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jensen', 'Affiliation': 'Spine Center, Research Unit, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Andersen', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'René D', 'Initials': 'RD', 'LastName': 'Østgård', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Niels T', 'Initials': 'NT', 'LastName': 'Andersen', 'Affiliation': 'Department of Biostatistics, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'DEFACTUM, Central Denmark Region, Aarhus, Denmark.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06046-6']
704,32162287,Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study.,"BACKGROUND


A novel fork-tip fine-needle biopsy (FNB) needle has recently been introduced for endoscopic ultrasound (EUS)-guided sampling. The aim of this study was to compare the performance of fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology in the diagnosis of solid pancreatic masses.
METHODS


A randomized crossover study was performed in patients referred for EUS-guided sampling. Three passes were taken with each needle in a randomized order. Only samples reported as diagnostic of malignancy were considered positive. The primary end point was the sensitivity of diagnosis of malignancy. Secondary end points included the amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost.
RESULTS


108 patients were recruited. Median age was 69 years (range 30 - 87) and 57 were male; 85.2 % had a final diagnosis of malignancy. There were statistically significant differences in sensitivity (82 % [95 % confidence interval (CI) 72 % to 89 %] vs. 71 % [95 %CI 60 % to 80 %]), accuracy (84 % [95 %CI 76 % to 91 %] vs. 75 % [95 %CI 66 % to 83 %]), proportion graded as a straightforward diagnosis (69 % [95 %CI 60 % to 78 %] vs. 51 % [95 %CI 41 % to 61 %]), and median pathology viewing time (188 vs. 332 seconds) ( P  < 0.001) between FNB and FNA needles, respectively. There was no significant difference in cost between an FNB or FNA strategy.
CONCLUSION


The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.",2020,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","['Median age was 69 years (range 30\u200a-\u200a87) and 57 were male; 85.2\u200a% had a final diagnosis of malignancy', '108 patients were recruited', 'patients referred for EUS-guided sampling']","['Fork-tip needle biopsy versus fine-needle aspiration', 'endoscopic ultrasound-guided sampling of solid pancreatic masses', 'fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology', 'FNA', 'novel fork-tip fine-needle biopsy ']","['amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost', 'sensitivity of diagnosis of malignancy', 'median pathology viewing time', 'accuracy', 'sensitivity', 'straightforward diagnosis']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0546910', 'cui_str': 'Fork (physical object)'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy (procedure)'}]","[{'cui': 'C1277697', 'cui_str': 'Sample obtained'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1272701', 'cui_str': 'Straightforward'}]",108.0,0.0843607,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","[{'ForeName': 'Kofi W', 'Initials': 'KW', 'LastName': 'Oppong', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Noor L H', 'Initials': 'NLH', 'LastName': 'Bekkali', 'Affiliation': 'Department of Gastroenterology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Leeds', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Manu K', 'Initials': 'MK', 'LastName': 'Nayar', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Darné', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Egan', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy, Amersham, United Kingdom.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Haugk', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}]",Endoscopy,['10.1055/a-1114-5903']
705,30298608,Benefit of Early versus Deferred Antiretroviral Therapy on Progression of Liver Fibrosis among People with HIV in the START Randomized Trial.,"The role of antiretroviral therapy (ART) in reducing or contributing to liver fibrosis in persons with human immunodeficiency virus (HIV) is unclear. We evaluated participants in the Strategic Timing of AntiRetroviral Treatment (START) trial for liver fibrosis using the AST to Platelet Ratio Index (APRI) and Fibrosis-4 Index (FIB-4), and assessed for a benefit of early versus delayed ART on liver fibrosis progression. ART-naïve persons with high CD4 counts (>500 cells/µL) from 222 clinical sites in 35 countries were randomized to receive ART either at study enrollment (immediate treatment arm) or when their CD4 count fell below 350 cells/µL (deferred treatment arm). The following outcomes were evaluated: fibrosis (APRI > 0.5 or FIB-4 > 1.45), significant fibrosis (APRI > 1.5 or FIB-4 > 3.25), hepatic flare, and resolution of elevated APRI and FIB-4 scores. Of the 4,684 enrolled into the START study, 104 did not have APRI or FIB-4 results and were excluded. Among 4,580 participants (2,273 immediate treatment; 2,307 deferred treatment), the median age was 36 years, 26.9% were female, and 30.4% were black. Three percent had an alcoholism or substance abuse history, 6.4% had hepatitis B and/or C, and 1.1% had significant fibrosis at baseline. The median CD4 count was 651, and 5.3% had HIV RNA ≤ 200. Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001). Conclusions: Significant liver fibrosis was rare among ART-naïve HIV-positive persons with high CD4 counts. Our findings suggest a benefit of early ART in preventing the development of liver fibrosis.",2019,Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001).,"['ART-naïve persons with high CD4 counts (>500 cells/µL) from 222 clinical sites in 35 countries', '4,580 participants (2,273 immediate treatment; 2,307 deferred treatment), the median age was 36 years, 26.9% were female, and 30.4% were black', 'People with HIV', 'persons with human immunodeficiency virus (HIV', '4,684 enrolled into the START study, 104 did not have APRI or FIB-4 results and were excluded']","['Early versus Deferred Antiretroviral Therapy', 'antiretroviral therapy (ART']","['hepatic flare, and resolution of elevated APRI and FIB-4 scores', 'Platelet Ratio Index (APRI) and Fibrosis-4 Index (FIB-4', 'alcoholism or substance abuse history', 'fibrosis scores', 'Significant liver fibrosis', 'median CD4 count', 'Progression of Liver Fibrosis']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",4684.0,0.154622,Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001).,"[{'ForeName': 'Nila J', 'Initials': 'NJ', 'LastName': 'Dharan', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Juergen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Peters', 'Affiliation': 'CHIP, Department of Infectious Disease, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gordin', 'Affiliation': 'VA Medical Center, Washington, DC.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arenas-Pinto', 'Affiliation': 'MRC Clinical Trails Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Emerson', 'Affiliation': 'Belfast Healthcare Trust, Belfast, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Marks', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Hidalgo', 'Affiliation': 'Vía Libre / Guillermo Almenara Hospital, Lima, Peru.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sarmento-Castro', 'Affiliation': 'University Hospital of Porto, Porto, Portugal.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stephan', 'Affiliation': 'Johann Wolfgang Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YRGCARE Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Gail V', 'Initials': 'GV', 'LastName': 'Matthews', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30296']
706,32162103,Cannabinoid modulation of corticolimbic activation to threat in trauma-exposed adults: a preliminary study.,"RATIONALE


Excessive fear and anxiety, coupled with corticolimbic dysfunction, are core features of stress- and trauma-related psychopathology, such as posttraumatic stress disorder (PTSD). Interestingly, low doses of ∆ 9 -tetrahydrocannabinol (THC) can produce anxiolytic effects, reduce threat-related amygdala activation, and enhance functional coupling between the amygdala and medial prefrontal cortex and adjacent rostral cingulate cortex (mPFC/rACC) during threat processing in healthy adults. Together, these findings suggest the cannabinoid system as a potential pharmacological target in the treatment of excess fear and anxiety. However, the effects of THC on corticolimbic functioning in response to threat have not be investigated in adults with trauma-related psychopathology.
OBJECTIVE


To address this gap, the present study tests the effects of an acute low dose of THC on corticolimbic responses to threat in three groups of adults: (1) non-trauma-exposed healthy controls (HC; n = 25), (2) trauma-exposed adults without PTSD (TEC; n = 27), and (3) trauma-exposed adults with PTSD (n = 19).
METHODS


Using a randomized, double-blind, placebo-controlled, between-subjects design, 71 participants were randomly assigned to receive either THC or placebo (PBO) and subsequently completed a well-established threat processing paradigm during functional magnetic resonance imaging.
RESULTS


In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
CONCLUSIONS


These preliminary data suggest that THC modulates threat-related processing in trauma-exposed individuals with PTSD, which may prove advantageous as a pharmacological approach to treating stress- and trauma-related psychopathology.",2020,"In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
","['trauma-exposed adults', 'adults with trauma-related psychopathology', 'healthy adults', 'three groups of adults: (1) non-trauma-exposed healthy controls (HC; n\xa0=\u200925), (2) trauma-exposed adults without PTSD (TEC; n\xa0=\u200927), and (3) trauma-exposed adults with PTSD (n\xa0=\u200919', '71 participants']","['placebo', 'tetrahydrocannabinol (THC', 'THC or placebo (PBO) and subsequently completed a well-established threat processing paradigm during functional magnetic resonance imaging', 'THC']","['mPFC activation', 'mPFC-amygdala functional coupling']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",71.0,0.078447,"In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
","[{'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA. rabinak@wayne.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Blanchette', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Zabik', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Marusak', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Allesandra', 'Initials': 'A', 'LastName': 'Iadipaolo', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Farrah', 'Initials': 'F', 'LastName': 'Elrahal', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05499-8']
707,31812183,Factors influencing adherence in a trial of early introduction of allergenic food.,"BACKGROUND


The Enquiring About Tolerance (EAT) study examined whether the early introduction of 6 allergenic foods from 3 months of age in exclusively breastfed infants prevented the development of food allergy. The intervention was effective in the per-protocol analysis for allergy to 1 or more foods and for egg and peanut individually, but only 42% of early introduction group (EIG) children met the per-protocol criteria.
OBJECTIVE


We sought to identify which factors were responsible for nonadherence in the EAT study.
METHODS


Factors influencing adherence within the key early introduction period in the EIG (up to 6 months of age) were divided into enrollment and postenrollment factors, and their association with nonadherence was explored.
RESULTS


In an adjusted analysis, at enrollment, increased maternal age, nonwhite ethnicity, and lower maternal quality of life were independently and significantly associated with overall nonadherence in the EIG. Enrollment eczema and enrollment serum allergen-specific IgE sensitization to 1 or more foods (≥0.1 kU/L) were not related to overall nonadherence. After enrollment, 2 factors were significantly related to EIG overall nonadherence: parent-reported IgE-type symptoms with infant allergenic food consumption by 6 months of age and reported feeding difficulties by 4 months of age.
CONCLUSION


If early introduction of allergenic foods were to be considered a strategy to prevent food allergy, families of nonwhite ethnicity, those with older mothers, and those with infants with reported feeding difficulties or early-onset eczema would benefit from support to promote early and sustained consumption.",2019,"The intervention was effective in the per-protocol analysis for allergy to 1 or more foods and for egg and peanut individually, but only 42% of early introduction group (EIG) children met the per-protocol criteria.
",[],[],"['EIG overall nonadherence: parent-reported IgE-type symptoms with infant allergenic food consumption', 'maternal age, nonwhite ethnicity, and lower maternal quality of life']",[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0034380'}]",,0.063514,"The intervention was effective in the per-protocol analysis for allergy to 1 or more foods and for egg and peanut individually, but only 42% of early introduction group (EIG) children met the per-protocol criteria.
","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Benaroya Research Institute, Seattle, Wash.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Research Group Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Research Group Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Research Group Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knibb', 'Affiliation': 'Department of Psychology, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Research Group Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Mills', 'Affiliation': 'School of Biological Sciences, Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, and the Manchester Institute of Biotechnology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Versteeg', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Ree', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, the Netherlands; Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Research Group Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom. Electronic address: gideon.lack@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.046']
708,32161992,Bifrontal transcranial direct current stimulation modulates fatigue in multiple sclerosis: a randomized sham-controlled study.,"Fatigue is a frequent and debilitating symptom in patients with central nervous system diseases. Up to 90% of patients with multiple sclerosis (MS) suffer from fatigue that drastically affects the quality of life. MS patients also complain of anxiety and depressive symptoms and these three manifestations tend to cluster together in this clinical population. The objective of this work was to assess the effects of transcranial direct stimulation (tDCS), a noninvasive brain stimulation technique, on fatigue as well as anxiety and depressive symptoms. Eleven fatigued MS patients randomly received two blocks (active and sham tDCS) of five consecutive daily sessions of bifrontal tDCS (anode/cathode over the left/right prefrontal cortices, respectively) in a crossover manner, separated by a 3-week washout interval. Evaluation took place at day 1, day 5 (right after each block) and 1 week later. Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05). Active tDCS also significantly improved anxiety symptoms, but the effect emerged 1 week later (p < 0.05). No significant effects were obtained regarding depression (p > 0.05). Bifrontal tDCS seems to modulate fatigue in PwMS. The observed anxiolytic effects could constitute delayed after effects of tDCS or might be mediated by fatigue improvement. These findings merit to be addressed in large-scale controlled trials.",2020,"Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05).","['Eleven fatigued MS patients randomly received', 'multiple sclerosis', 'patients with central nervous system diseases']","['two blocks (active and sham tDCS', 'tDCS', 'Bifrontal transcranial direct current stimulation', 'transcranial direct stimulation (tDCS']","['complain of anxiety and depressive symptoms', 'quality of life', 'anxiety symptoms', 'fatigue', 'anxiety and depressive symptoms']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0007682', 'cui_str': 'CNS Diseases'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0220744,"Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05).","[{'ForeName': 'Moussa A', 'Initials': 'MA', 'LastName': 'Chalah', 'Affiliation': 'EA 4391, Excitabilité Nerveuse et Thérapeutique, Université Paris-Est-Créteil, Créteil, France.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grigorescu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Kümpfel', 'Affiliation': 'Institute for Clinical Neuroimmunology, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Samar S', 'Initials': 'SS', 'LastName': 'Ayache', 'Affiliation': 'EA 4391, Excitabilité Nerveuse et Thérapeutique, Université Paris-Est-Créteil, Créteil, France. samarayache@gmail.com.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02166-2']
709,31123008,"Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia: a protocol for a randomIsed controlled Trial (CAP-IT).","INTRODUCTION


Community-acquired pneumonia (CAP) is a common indication for antibiotic treatment in young children. Data are limited regarding the ideal dose and duration of amoxicillin, leading to practice variation which may impact on treatment failure and antimicrobial resistance (AMR). Community-Acquired Pneumonia: a randomIsed controlled Trial (CAP-IT) aims to determine the optimal amoxicillin treatment strategies for CAP in young children in relation to efficacy and AMR.
METHODS AND ANALYSIS


The CAP-IT trial is a multicentre, randomised, double-blind, placebo-controlled 2×2 factorial non-inferiority trial of amoxicillin dose and duration. Children are enrolled in paediatric emergency and inpatient environments, and randomised to receive amoxicillin 70-90 or 35-50 mg/kg/day for 3 or 7 days following hospital discharge. The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation. Secondary outcomes include adverse events, severity and duration of parent-reported CAP symptoms, adherence and antibiotic resistance. The primary analysis will be by intention to treat. Assuming a 15% primary outcome event rate, 8% non-inferiority margin assessed against an upper one-sided 95% CI, 90% power and 15% loss to follow-up, 800 children will be enrolled to demonstrate non-inferiority for the primary outcome for each of duration and dose.
ETHICS AND DISSEMINATION


The CAP-IT trial and relevant materials were approved by the National Research Ethics Service (reference: 16/LO/0831; 30 June 2016). The CAP-IT trial results will be published in peer-reviewed journals, and in a report published by the National Institute for Health Research Health Technology Assessment programme. Oral and poster presentations will be given to national and international conferences, and participating families will be notified of the results if they so wish. Key messages will be constructed in partnership with families, and social media will be used in their dissemination.
TRIAL REGISTRATION NUMBER


ISRCTN76888927, EudraCT2016-000809-36.",2019,The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation.,"['young children with Community-Acquired Pneumonia', 'young children', 'Community-Acquired Pneumonia']","['amoxicillin', 'placebo']","['adverse events, severity and duration of parent-reported CAP symptoms, adherence and antibiotic resistance', 'systemic antibacterial treatment for respiratory tract infection (including CAP', 'Efficacy, safety']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",800.0,0.490883,The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation.,"[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Lyttle', 'Affiliation': 'Emergency Department, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Bielicki', 'Affiliation': ""Paediatric Infectious Diseases Research Group, MRC Clinical Trial Unit at UCL, Institute for Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Barratt', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunn', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': ""Bristol Children's Vaccine Centre, Schools of Population Sciences and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Jackson', 'Affiliation': 'Emergency Department, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Colin V E', 'Initials': 'CVE', 'LastName': 'Powell', 'Affiliation': 'Paediatric Emergency Medicine Department, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Roland', 'Affiliation': 'Emergency Department, Paediatric Emergency Medicine Leicester Academic (PEMLA) Group, Leicester, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stohr', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': ""NIHR CRN: Children, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robotham', 'Affiliation': 'HCAI and AMR Division, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, University of Bristol, Bristol, UK.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sharland', 'Affiliation': ""Paediatric Infectious Diseases Research Group, MRC Clinical Trial Unit at UCL, Institute for Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029875']
710,31923099,"Effects of keto acid supplements on Chinese patients receiving maintenance hemodialysis: a prospective, randomized, controlled, single-center clinical study.","BACKGROUND


The effects of keto acid (KA) supplements on Chinese patients receiving maintenance hemodialysis (MHD) are unclear. This study aimed to evaluate the effects of KA supplementation on nutritional status, inflammatory markers, and bioelectric impedance analysis (BIA) parameters in a cohort of Chinese patients with MHD without malnutrition.
METHODS


This was a prospective, randomized, controlled, single-center clinical study conducted in 2011 till 2014. Twenty-nine patients with MHD were randomly assigned to a control (n = 14) or a KA (n = 15) group. The control group maintained a dietary protein intake of 0.9 g/kg/day. The KA group received additional KA supplement (0.1 g/kg/day). BIA was used to determine the lean tissue mass, adipose tissue mass, and body cell mass. The patients' nutritional status, dialysis adequacy, and biochemical parameters were assessed at the ends of the third and sixth months with t test or Wilcoxon rank-sum test.
RESULTS


The daily total energy intake for both groups was about 28 kcal/kg/day. After 6 months, the Kt/V (where K is the dialyzer clearance of urea, t is the dialysis time, and V is the volume of the distribution of urea) was 1.33 ± 0.25 in KA group, and 1.34 ± 0.25 in the control group. The median triceps skin-fold thickness in KA group was 12.00 and 9.00 mm in the control group. In addition, the median hand-grip strength in KA group was 21.10 and 25.65 kg in the control group. There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA. Both groups achieved dialysis adequacy and maintained nutritional status during the study.
CONCLUSIONS


In this cohort of Chinese patients with MHD, the patients in the control group whose dietary protein intake was 0.9 g/kg/day and total energy intake was 28 kcal/kg/day, maintained well nutritional status during study period. The KA supplement (0.1 g/kg/day) did not improve the essential amino acid/non-essential amino acid ratio, nor did it change the patients' mineral metabolism, inflammatory parameters, or body compositions.",2020,"There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA.","['Twenty-nine patients with MHD', 'Chinese patients with MHD without malnutrition', 'Chinese patients with MHD', 'Chinese patients receiving maintenance hemodialysis', '2011 till 2014', 'Chinese patients receiving maintenance hemodialysis (MHD']","['additional KA supplement', 'KA', 'keto acid supplements', 'KA supplementation', 'keto acid (KA) supplements']","['daily total energy intake', 'total energy intake', 'dialysis adequacy and maintained nutritional status', 'dietary protein intake', 'median hand-grip strength', 'lean tissue mass, adipose tissue mass, and body cell mass', 'anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA', 'median triceps skin-fold thickness', 'nutritional status, inflammatory markers, and bioelectric impedance analysis (BIA) parameters']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0022618', 'cui_str': 'Oxo Acids'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness (observable entity)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0236773,"There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA.","[{'ForeName': 'Hai-Long', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Nutrition, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shanxi Medical College Affiliated First Hospital, Taiyuan, Shanxi 030001, China.'}, {'ForeName': 'Yi-Fu', 'Initials': 'YF', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Shijiazhuang Third Hospital, Shijiazhuang, Hebei 050011, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Nephrology, Shanxi Medical College Affiliated Second Hospital, Taiyuan, Shanxi 030001, China.'}, {'ForeName': 'Wei-Qi', 'Initials': 'WQ', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Shi-Qin', 'Initials': 'SQ', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Chen-Die', 'Initials': 'CD', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Qiqihar Medical College Affiliated Third Hospital, Qiqihar, Heilongjiang 161000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Statistics, Institute of Basic Medical Sciences, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Nutrition, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Jian-Ling', 'Initials': 'JL', 'LastName': 'Tao', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Xue-Wang', 'Initials': 'XW', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000578']
711,31209698,Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials.,"INTRODUCTION


Two multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping.
METHODS


Subjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).
RESULTS


A total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ ""Sleep Problems"" domain or the ""Feel Tired and Unrefreshed"" item of the ""Symptoms on Waking in the Morning"" domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated.
CONCLUSIONS


BRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect.
FUNDING


GlaxoSmithKline Consumer Healthcare. CLINICALTRIALS.
GOV REGISTRATION NUMBERS


Study 1: NCT03549117; Study 2: NCT03549130.",2019,"There was no significant difference between BRNS and placebo on either the NRQLQ ""Sleep Problems"" domain or the ""Feel Tired and Unrefreshed"" item of the ""Symptoms on Waking in the Morning"" domain at day 7 or 14.","['A total of 140 subjects were randomized in Study 1, and 130 in Study 2', 'otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping', 'Subjects']","['placebo strip', 'placebo strips', 'placebo', 'Breathe Right Nasal Strips (BRNS']","['Efficacy', 'subjective measures of sleep quality and nasal congestion', 'Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ', 'tolerated', 'NRQLQ ""Sleep Problems"" domain or the ""Feel Tired and Unrefreshed"" item of the ""Symptoms on Waking', 'sleep-related quality of life', 'Sleep Quality and Congestion']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0849970', 'cui_str': 'Feeling tired'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0585034', 'cui_str': 'On waking (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}]",140.0,0.61177,"There was no significant difference between BRNS and placebo on either the NRQLQ ""Sleep Problems"" domain or the ""Feel Tired and Unrefreshed"" item of the ""Symptoms on Waking in the Morning"" domain at day 7 or 14.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noss', 'Affiliation': 'Synexus (Formerly Radiant Research), Cincinnati, OH, USA. michaelnossmd@gmail.com.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Ciesla', 'Affiliation': 'Clinical Development and Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Shanga', 'Affiliation': 'Biostatistics Research and Development, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-019-01005-5']
712,31209699,Clinical and Psychological Outcomes of the Use of Vaginal Dilators After Gynaecological Brachytherapy: a Randomized Clinical Trial.,"INTRODUCTION


The aim of this study was to evaluate the dimensions of the vaginal canal in patients undergoing gynaecological brachytherapy and the effect of the use of vaginal dilators (VD) used in the follow-up of pelvic physiotherapy.
METHODS


A total of 88 patients were randomly allocated to the control group (CG) and intervention group (IG). Three evaluations were performed: pre-brachytherapy, post-brachytherapy and follow-up of 3 months. The CG received standard guidance from the health team while the IG was instructed to use VD for 3 months. The dimensions of the vaginal canal (main outcome) were defined by the length of the vagina (centimetres), width (number of full clockwise turns of the opening thread of a gynaecological speculum) and area (defined by the size of the VD). Quality of life and pelvic floor (PF) functionality were also evaluated.
RESULTS


There was no effect of the VD on vaginal length, width and area among the intention-to-treat (ITT) population. However, in the analysis stratified by adhesion, the CG had a significant decrease in the vaginal area. PF was predominantly hypoactive throughout the follow-up. Quality of life improved in both groups, but the reduction of constipation, vaginal dryness and stress urinary incontinence manifested only in the IG.
CONCLUSION


The use of VD did not alter the dimensions of the vaginal canal within the first 3 months after the end of radiotherapy treatment. However, there was a large sample loss during follow-up so studies with a larger sample number and longer follow-up time need to be conducted.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03090217.",2019,The use of VD did not alter the dimensions of the vaginal canal within the first 3 months after the end of radiotherapy treatment.,"['88 patients', 'patients undergoing']","['Gynaecological Brachytherapy', 'gynaecological brachytherapy', 'Vaginal Dilators', 'pre-brachytherapy, post-brachytherapy', 'control group (CG) and intervention group (IG', 'vaginal dilators (VD']","['Quality of life and pelvic floor (PF) functionality', 'constipation, vaginal dryness and stress urinary incontinence', 'Quality of life', 'length of the vagina (centimetres), width (number of full clockwise turns of the opening thread of a gynaecological speculum) and area (defined by the size of the VD', 'vaginal length, width and area among the intention-to-treat (ITT) population', 'vaginal area']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0180446', 'cui_str': 'Vaginal dilator'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0042232', 'cui_str': 'Vagina'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",88.0,0.0394298,The use of VD did not alter the dimensions of the vaginal canal within the first 3 months after the end of radiotherapy treatment.,"[{'ForeName': 'Taís Marques', 'Initials': 'TM', 'LastName': 'Cerentini', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Schlöttgen', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Viana da Rosa', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Valentina Lucia', 'Initials': 'VL', 'LastName': 'La Rosa', 'Affiliation': 'Unit of Psychodiagnostics and Clinical Psychology, University of Catania, Catania, Italy.'}, {'ForeName': 'Salvatore Giovanni', 'Initials': 'SG', 'LastName': 'Vitale', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy. sgvitale@unict.it.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Giampaolino', 'Affiliation': 'Department of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Valenti', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': 'Unità Operativa Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Fabrício Edler', 'Initials': 'FE', 'LastName': 'Macagnan', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}]",Advances in therapy,['10.1007/s12325-019-01006-4']
713,30900550,Electronically delivered interventions to reduce antibiotic prescribing for respiratory infections in primary care: cluster RCT using electronic health records and cohort study.,"BACKGROUND


Unnecessary prescribing of antibiotics in primary care is contributing to the emergence of antimicrobial drug resistance.
OBJECTIVES


To develop and evaluate a multicomponent intervention for antimicrobial stewardship in primary care, and to evaluate the safety of reducing antibiotic prescribing for self-limiting respiratory infections (RTIs).
INTERVENTIONS


A multicomponent intervention, developed as part of this study, including a webinar, monthly reports of general practice-specific data for antibiotic prescribing and decision support tools to inform appropriate antibiotic prescribing.
DESIGN


A parallel-group, cluster randomised controlled trial.
SETTING


The trial was conducted in 79 general practices in the UK Clinical Practice Research Datalink (CPRD).
PARTICIPANTS


All registered patients were included.
MAIN OUTCOME MEASURES


The primary outcome was the rate of antibiotic prescriptions for self-limiting RTIs over the 12-month intervention period.
COHORT STUDY


A separate population-based cohort study was conducted in 610 CPRD general practices that were not exposed to the trial interventions. Data were analysed to evaluate safety outcomes for registered patients with 45.5 million person-years of follow-up from 2005 to 2014.
RESULTS


There were 41 intervention trial arm practices (323,155 patient-years) and 38 control trial arm practices (259,520 patient-years). There were 98.7 antibiotic prescriptions for RTIs per 1000 patient-years in the intervention trial arm (31,907 antibiotic prescriptions) and 107.6 per 1000 patient-years in the control arm (27,923 antibiotic prescriptions) [adjusted antibiotic-prescribing rate ratio (RR) 0.88, 95% confidence interval (CI) 0.78 to 0.99;  p  = 0.040]. There was no evidence of effect in children aged < 15 years (RR 0.96, 95% CI 0.82 to 1.12) or adults aged ≥ 85 years (RR 0.97, 95% CI 0.79 to 1.18). Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year. Analysis of trial data for 12 safety outcomes, including pneumonia and peritonsillar abscess, showed no evidence that these outcomes might be increased as a result of the intervention. The analysis of data from non-trial practices showed that if a general practice with an average list size of 7000 patients reduces the proportion of RTI consultations with antibiotics prescribed by 10%, then 1.1 (95% CI 0.6 to 1.5) more cases of pneumonia per year and 0.9 (95% CI 0.5 to 1.3) more cases of peritonsillar abscesses per decade may be observed. There was no evidence that mastoiditis, empyema, meningitis, intracranial abscess or Lemierre syndrome were more frequent at low-prescribing practices.
LIMITATIONS


The research was based on electronic health records that may not always provide complete data. The number of practices included in the trial was smaller than initially intended.
CONCLUSIONS


This study found evidence that, overall, general practice antibiotic prescribing for RTIs was reduced by this electronically delivered intervention. Antibiotic prescribing rates were reduced for adults aged 15-84 years, but not for children or the senior elderly.
FUTURE WORK


Strategies for antimicrobial stewardship should employ stratified interventions that are tailored to specific age groups. Further research into the safety of reduced antibiotic prescribing is also needed.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN95232781.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 11. See the NIHR Journals Library website for further project information.",2019,"Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year.","['All registered patients were included', 'adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year', 'A separate population-based cohort study was conducted in 610 CPRD general practices that were not exposed to the trial interventions', 'adults aged 15-84 years, but not for children or the senior elderly', 'registered patients with 45.5 million person-years of follow-up from 2005 to 2014', '79 general practices in the UK Clinical Practice Research Datalink (CPRD']",['multicomponent intervention'],"['safety outcomes', 'proportion of RTI consultations', 'Antibiotic prescribing rates', 'mastoiditis, empyema, meningitis, intracranial abscess or Lemierre syndrome', 'pneumonia and peritonsillar abscess', 'rate of antibiotic prescriptions for self-limiting RTIs', 'Antibiotic prescribing']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0444894', 'cui_str': 'CI 40'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0024904', 'cui_str': 'Mastoiditis'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0021874', 'cui_str': 'Intracranial abscess (disorder)'}, {'cui': 'C0343525', 'cui_str': 'Lemierre Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0031157', 'cui_str': 'Peritonsillar Abscess'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.254537,"Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year.","[{'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Gulliford', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Juszczyk', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Soames', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDermott', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Kirin', 'Initials': 'K', 'LastName': 'Sultana', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'The Health Centre, Bicester, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Charlton', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23110']
714,31264183,Building a physical activity intervention into clinical care for breast and colorectal cancer survivors in Wisconsin: a randomized controlled pilot trial.,"BACKGROUND


Cancer survivorship care plans (""care plans"") often recommend an active lifestyle yet are rarely accompanied by programs to help patients enact the prescribed behavior change. As a step towards bridging this gap, this trial tested the feasibility of augmenting care planning with a multi-level physical activity intervention.
METHODS


Breast and colorectal cancer survivors were enrolled alongside a self-selected support partner (e.g., spouse, friend). Survivors received a care plan alone (comparison group) versus one augmented with a 12-week physical activity module (intervention group). For the intervention group dyads, both members received a multi-component program including Fitbit trackers, with the survivor's Fitbit linked to his/her electronic health record (EHR). Treating clinicians received periodic updates regarding the survivors' physical activity. The primary outcome was ActiGraph-measured physical activity, analyzed using mixed models. Feedback questionnaires were administered to participants and clinicians at 12 weeks.
RESULTS


Survivors (n = 50) were 54.4 ± 11.2 years of age and 2.0 ± 1.5 years post-diagnosis. Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001). Likewise, daily steps increased by 1470 ± 1881 vs. a 398 ± 1751 decrease (P = .002). Among responding clinicians, 100% looked at survivors' activity data within the EHR at least once and 80% said it provided insight into their patients' lifestyles.
CONCLUSIONS


Augmenting a standard care plan with a multi-level, technology-based intervention increased physical activity among cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS


Technology-based approaches, including activity trackers, can be used by individuals to work towards an active lifestyle after cancer.",2019,Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001).,"['Survivors (n\u2009=\u200950) were 54.4\u2009±\u200911.2\xa0years of age and 2.0\u2009±\u20091.5\xa0years post-diagnosis', 'breast and colorectal cancer survivors in Wisconsin', 'Breast and colorectal cancer survivors were enrolled alongside a self-selected support partner (e.g., spouse, friend']","['standard care plan with a multi-level, technology-based intervention', 'physical activity intervention', ""multi-component program including Fitbit trackers, with the survivor's Fitbit linked to his/her electronic health record (EHR"", 'care plan alone (comparison group) versus one augmented with a 12-week physical activity module (intervention group']","['ActiGraph-measured physical activity', 'physical activity', 'moderate-to-vigorous-intensity physical activity (MVPA']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0651691,Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadmus-Bertram', 'Affiliation': 'Department of Kinesiology, University of Wisconsin - Madison, 2000 Observatory Drive, Madison, WI, 53706, USA. lisa.bertram@wisc.edu.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Sesto', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Van Remortel', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Preshita', 'Initials': 'P', 'LastName': 'Date', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin - Madison, Madison, WI, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00778-6']
715,31335650,"OPRM1 rs1799971, COMT rs4680, and FAAH rs324420 genes interact with placebo procedures to induce hypoalgesia.","Genetics studies on the placebo hypoalgesic effect highlight a promising link between single nucleotide polymorphisms (SNPs) in the dopamine, opioid, and endocannabinoid genes and placebo hypoalgesia. However, epistasis and replication studies are missing. In this study, we expanded on previous findings related to the 3 SNPs in the opioid receptor mu subunit (OPRM1 rs1799971), catechol-O-methyltransferase (COMT rs4680), and fatty acid amide hydrolase (FAAH rs324420) genes associated with placebo hypoalgesia and tested the effect of a 3-way interaction on placebo hypoalgesia. Using 2 well-established placebo procedures (verbal suggestion and learning paradigm), we induced significant placebo hypoalgesic effects in 160 healthy participants. We found that individuals with OPRM1 AA combined with FAAH Pro/Pro and those carrying COMT met/met together with FAAH Pro/Pro showed significant placebo effects. Participants with COMT met/val alleles showed significant placebo effects independently of OPRM1 and FAAH allele combinations. Finally, the model that included the placebo procedure and genotypes predicted placebo responsiveness with a higher accuracy (area under the curve, AUC = 0.773) as compared to the SNPs alone indicating that genetic variants can only partially explain the placebo responder status. Our results suggest that the endogenous mu-opioid system with a larger activation in response to pain in the met/val allele carriers as well as the synergism between endogenous mu-opioid system and cannabinoids might play the most relevant role in driving hypoalgesic responses. Future epistasis studies with larger sample sizes will help us to fully understand the complexity of placebo effects and explain the mechanisms that underlie placebo responsiveness.",2019,Participants with COMT met/val alleles showed significant placebo effects independently of OPRM1 and FAAH allele combinations.,['160 healthy participants'],['placebo procedures (verbal suggestion and learning paradigm'],[],"[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],160.0,0.212109,Participants with COMT met/val alleles showed significant placebo effects independently of OPRM1 and FAAH allele combinations.,"[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Martinez', 'Affiliation': 'National Institute of Mental Health (NIMH), Bethesda, MD, United States.'}, {'ForeName': 'Yen-Pei C', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Departments of Medicine, University of Maryland, Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Ryan', 'Affiliation': 'Departments of Medicine, University of Maryland, Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hodgkinson', 'Affiliation': 'Laboratory of Neurogenetics, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldman', 'Affiliation': 'Laboratory of Neurogenetics, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, United States.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Dorsey', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001578']
716,30312434,Presence of Circulating Tumor Cells in High-Risk Early Breast Cancer During Follow-Up and Prognosis.,"BACKGROUND


The prognostic relevance of circulating tumor cells (CTCs) at the time of primary diagnosis has been well established. However, little information is available regarding their prognostic relevance to follow-up care.
METHODS


The multicenter, open-label, phase III SUCCESS A trial compared two adjuvant chemotherapy regimens followed by 2 vs 5 years of zoledronate for early-stage, high-risk breast cancer patients. The presence of CTCs was assessed before and 2 years after chemotherapy using the FDA-approved CellSearch System. Overall survival (OS) and disease-free survival (DFS) were analyzed using univariate log-rank tests and multivariable Cox regressions. OS and DFS were measured starting from an assessment of CTCs 2 years after the completion of chemotherapy. All statistical tests were two-sided.
RESULTS


The sample included 1087 patients who participated in the translational research program of the SUCCESS A trial and for whom sufficient translational data were available regarding CTC status at baseline and at the 2-year follow-up visit. Two years after chemotherapy, 198 (18.2%) patients were CTC-positive. The median follow-up after this timepoint was 37 months. Cox regressions that included CTC status at baseline revealed that CTC status 2 years after chemotherapy had statistically significant and independent prognostic relevance for OS (hazard ratio [HR] = 3.91, 95% confidence interval [CI] = 2.04 to 7.52, P < .001) and DFS (HR = 2.31, 95% CI = 1.50 to 3.55, P < .001).
CONCLUSION


The presence of CTCs 2 years after chemotherapy was associated with decreased OS and DFS. Based on these results, active individualized surveillance strategies for breast cancer survivors based on biomarkers should be reconsidered.",2019,Cox regressions that included CTC status at baseline revealed that CTC status 2 years after chemotherapy had statistically significant and independent prognostic relevance for OS (hazard ratio [HR] =,"['for early-stage, high-risk breast cancer patients', '1087 patients who participated in the translational research program of the SUCCESS A trial and for whom sufficient translational data were available regarding CTC status at baseline and at the 2-year follow-up visit', 'High-Risk Early Breast Cancer', 'breast cancer survivors']",['zoledronate'],"['OS and DFS', 'DFS', 'Overall survival (OS) and disease-free survival (DFS']","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3494163', 'cui_str': 'Translational Researchs'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1087.0,0.0507792,Cox regressions that included CTC status at baseline revealed that CTC status 2 years after chemotherapy had statistically significant and independent prognostic relevance for OS (hazard ratio [HR] =,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Trapp', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindlbeck', 'Affiliation': 'Department of Gynecology and Obstetrics, Clinical Center Traunstein, Traunstein, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jückstock', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Andergassen', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Alunni-Fabbroni', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Tzschaschel', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Arkadius', 'Initials': 'A', 'LastName': 'Polasik', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Julian G', 'Initials': 'JG', 'LastName': 'Koch', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Haeberle', 'Affiliation': 'Department of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Ruprecht-Karls-University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pantel', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Department of Gynecology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scholz', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djy152']
717,31242937,Hand exercise for women with rheumatoid arthritis and decreased hand function: an exploratory randomized controlled trial.,"BACKGROUND


People with hand-related rheumatoid arthritis (RA) experience problems performing activities of daily living (ADL). Compensatory strategies to improve ADL ability have shown effective. Similarly, hand exercise has shown effect on pain, grip strength, and self-reported ability. A combination has shown positive effects based on self-report, but self-report and observation provide distinct information about ADL. The purpose of this study was to examine whether hand exercise as add on to compensatory intervention (CIP) will improve observed ADL ability in RA.
METHODS


Women (n = 55) with hand-related RA were randomized to CIP EXERCISE  (intervention) or CIP only (control). CIP is focused on joint protection, assistive devices, and alternative ways of performing AD. The hand-exercise program addressed range of motion and muscle strength. Primary outcome was change in observed ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS). Baseline measures were repeated after 8 weeks.
RESULTS


Improvements in ADL motor ability in CIP EXERCISE  (mean change = 0.24 logits; 95% CI = 0.09 to 0.39) and CIP CONTROL  (mean change =0.20 logits; 95% CI = 0.05 to 0.35) were statistically significant, with no differences between groups (mean difference = 0.04 logits; 95% CI = - 0.16 to 0.25). Thirteen (46.4%) participants in the CIP EXERCISE  and 12 (44.4%) in the CIP CONTROL  obtained clinically relevant improvements (≥ 0.30 logits) in ADL motor ability; this group difference was not significant (z = 0.15; p = 0.88).
CONCLUSION


Adding hand exercise to a compensatory intervention did not yield additional benefits in women with hand-related RA. The study was approved by the ethics committee 14th of April 2014 (H-3-2014-025) and registered at ClinicalTrials.gov 16th of May 2014 (NCT02140866).",2019,"RESULTS


Improvements in ADL motor ability in CIP EXERCISE  (mean change = 0.24 logits; 95% CI = 0.09 to 0.39) and CIP CONTROL  (mean change =0.20 logits; 95% CI = 0.05 to 0.35) were statistically significant, with no differences between groups (mean difference = 0.04 logits; 95% CI = - 0.16 to 0.25).","['Women (n\u2009=\u200955) with hand-related RA', 'women with hand-related RA', 'People with hand-related rheumatoid arthritis (RA) experience problems performing activities of daily living (ADL', 'women with rheumatoid arthritis and decreased hand function']","['CIP', 'compensatory intervention (CIP', 'CIP EXERCISE  (intervention) or CIP only (control', 'hand exercise', 'Hand exercise']","['pain, grip strength, and self-reported ability', 'observed ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises (regime/therapy)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451005', 'cui_str': 'Assessment of motor and process skills (assessment scale)'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]",,0.342433,"RESULTS


Improvements in ADL motor ability in CIP EXERCISE  (mean change = 0.24 logits; 95% CI = 0.09 to 0.39) and CIP CONTROL  (mean change =0.20 logits; 95% CI = 0.05 to 0.35) were statistically significant, with no differences between groups (mean difference = 0.04 logits; 95% CI = - 0.16 to 0.25).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ellegaard', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark. Karen.Ellegaard@regionh.dk.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'von Bülow', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Røpke', 'Affiliation': 'Metropolitan University College, Institute for Occupational Therapy and Physiotherapy, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Bartholdy', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark.'}, {'ForeName': 'Inge Skovby', 'Initials': 'IS', 'LastName': 'Hansen', 'Affiliation': 'Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Rifbjerg-Madsen', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark.'}, {'ForeName': 'Eva Ejlersen', 'Initials': 'EE', 'LastName': 'Wæhrens', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Nordre Fasanvej 57, DK-2000, Copenhagen F, Denmark.'}]",Arthritis research & therapy,['10.1186/s13075-019-1924-9']
718,31290996,"A phase 1 and randomized, placebo-controlled phase 2 trial of bevacizumab plus dasatinib in patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872.","BACKGROUND


Src signaling is markedly upregulated in patients with invasive glioblastoma (GBM) after the administration of bevacizumab. The Src family kinase inhibitor dasatinib has been found to effectively block bevacizumab-induced glioma invasion in preclinical models, which led to the hypothesis that combining bevacizumab with dasatinib could increase bevacizumab efficacy in patients with recurrent GBM.
METHODS


After the completion of the phase 1 component, the phase 2 trial (ClinicalTrials.gov identifier NCT00892177) randomized patients with recurrent GBM 2:1 to receive 100 mg of oral dasatinib twice daily (arm A) or placebo (arm B) on days 1 to 14 of each 14-day cycle combined with 10 mg/kg of intravenous bevacizumab on day 1 of each 14-day cycle. The primary endpoint was 6-month progression-free survival (PFS6).
RESULTS


In the 121 evaluable patients, the PFS6 rate was numerically, but not statistically, higher in arm A versus arm B (28.9% [95% CI, 19.5%-40.0%] vs 18.4% [95% CI, 7.7%-34.4%]; P = .22). Similarly, there was no significant difference in the median overall survival noted between the treatment arms (7.3 months and 7.7 months, respectively; P = .93). The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months). The incidence of grade ≥3 toxicity was comparable between treatment arms, with hematologic toxicities occurring more frequently in arm A versus arm B (15.7% vs 7.9%) (adverse events were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). Correlative tissue analysis demonstrated an association between pSRC/LYN signaling in patient tumors and outcome.
CONCLUSIONS


Despite upregulation of Src signaling in patients with GBM, the combination of bevacizumab with dasatinib did not appear to significantly improve the outcomes of patients with recurrent GBM compared with bevacizumab alone.",2019,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","['patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872', 'patients with GBM', 'patients with recurrent GBM', 'patients with invasive glioblastoma (GBM) after the administration of']","['bevacizumab plus dasatinib', '100\xa0mg of oral dasatinib twice daily (arm A) or placebo', 'bevacizumab', 'placebo']","['objective response rate', 'incidence of grade ≥3 toxicity', 'hematologic toxicities', 'median overall survival', 'PFS6 rate', 'bevacizumab efficacy', '6-month progression-free survival (PFS6']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.270075,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","[{'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Twohy', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David Dinh', 'Initials': 'DD', 'LastName': 'Tran', 'Affiliation': 'Oncology Division, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Suriya A', 'Initials': 'SA', 'LastName': 'Jeyapalan', 'Affiliation': 'Department of Neurology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Department of Hematology/Oncology, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Feathers', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Panos Z', 'Initials': 'PZ', 'LastName': 'Anastasiadis', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia Medical Center, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.32340']
719,30552531,Enhancing coping skills for persons with cancer utilizing mastery enhancement: a pilot randomized clinical trial.,"The purpose of this project was to develop a short-term, theory-based intervention for patients with self-reported limited self-efficacy to perform coping behaviors. Cancer patients with low coping self-efficacy were randomly assigned to a treatment (N = 66) or control condition (N = 68). The treatment, Mastery Enhancement Therapy, was based on self-regulation and self-efficacy theories. Measures of coping self-efficacy, functional status, depression, quality of life, and adjustment were administered at baseline, after session two, after the final (fourth) session, and at 3 months post-treatment. Control participants completed the measures at about the same time intervals. Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment. However, treatment participants with lower levels of functional status benefited more than controls on depression and adjustment at follow-up. Mastery Enhancement Therapy is a time-limited treatment that increases coping efficacy and subsequently adjustment during active medical treatment, and appears to warrant a large-scale RCT with patients with below average coping self-efficacy and moderate to high symptoms.",2019,"Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment.","['Cancer patients with low coping self-efficacy', 'patients with self', 'persons with cancer utilizing mastery enhancement']",[],"['coping self-efficacy, functional status, depression, quality of life, and adjustment', 'Enhancing coping skills', 'self-efficacy']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]",,0.0149667,"Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment.","[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Nairn', 'Affiliation': ', Novi, MI, USA.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Merluzzi', 'Affiliation': 'University of Notre Dame, Notre Dame, IN, 46556, USA. tmerluzz@nd.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-018-0004-y']
720,31153977,Retrieval of individual patient data depended on study characteristics: a randomized controlled trial.,"OBJECTIVES


The aim of the study was to examine the effect of providing a financial incentive to authors of randomized clinical trials (RCTs) to obtain individual patient data (IPD).
STUDY DESIGN AND SETTING


Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews. The authors were randomly allocated to the intervention (financial incentive with several contact approaches) or control group (using the same contact approaches). Studied outcomes are proportion of authors who provided IPD, time to obtain IPD, and completeness of IPD received.
RESULTS


Of the 129 authors contacted, 37 authors suggested or contacted a person or funder providing relevant details or showed interest to collaborate, whereas 45 authors directed us to contact a person or funder, lacked resources or time, did not have ownership or approval to share the IPD, or claimed IPD was too old. None of the authors shared their IPD. We contacted 17 sponsors and received two complete IPD datasets from one sponsor. The time to obtain IPD was >1 year after a sponsor's positive response. Common barriers included study identification, data ownership, limited data access, and required IPD licenses.
CONCLUSION


IPD sharing may depend on study characteristics, including funding type, study size, study risk of bias, and treatment effect, but not on providing a financial incentive.",2019,The time to obtain IPD was >,['Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews'],['intervention (financial incentive with several contact approaches) or control group'],"['proportion of authors who provided IPD, time to obtain IPD, and completeness of IPD received', 'time to obtain IPD']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1955832', 'cui_str': 'Systematic Review'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}]",,0.173825,The time to obtain IPD was >,"[{'ForeName': 'Areti Angeliki', 'Initials': 'AA', 'LastName': 'Veroniki', 'Affiliation': ""Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece; Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Surgery & Cancer, Institute of Reproductive and Developmental Biology, Faculty of Medicine, Imperial College, London, UK. Electronic address: averonik@cc.uoi.gr.""}, {'ForeName': 'Huda M', 'Initials': 'HM', 'LastName': 'Ashoor', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Susan P C', 'Initials': 'SPC', 'LastName': 'Le', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rios', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Stewart', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Northern Ireland Hub for Trials Methodology Research, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Mavridis', 'Affiliation': 'Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece; Paris Descartes University, Sorbonne Paris Cité, Faculté de Médecine, Paris, France.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Straus', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Geriatric Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Tricco', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Epidemiology Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.""}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.031']
721,31170515,"Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study.","OBJECTIVES


Recruitment to pragmatic trials is often difficult, and little is known about factors associated with key participation and treatment decisions. These were explored in the Prostate cancer testing and Treatment (ProtecT) study.
STUDY DESIGN AND SETTING


Baseline sociodemographic, patient-reported outcome, clinical history, and prostate cancer biopsy data were collected for all patients eligible to take part in the ProtecT trial, in a comprehensive cohort design. Men who rejected randomization specified a preferred option and were followed up identically to the randomized cohort. Factors associated with participation decisions, patient preferences, and reasons for changing treatment were explored.
RESULTS


Of 2,664 men with clinically localized prostate cancer, 997 (37%) rejected randomization. Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer. Among many factors measured, only a small number of weak associations were found for occupation groups and some patient symptoms. Similar percentages changed from the random allocation and initially stated preference.
CONCLUSION


The comprehensive cohort design provided new insights into trial recruitment and participation decisions. Opportunities to improve recruitment by supporting recruiters with equipoise and patient preferences were identified.",2019,Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer.,"['Men who rejected randomization specified a preferred option and were followed up identically to the randomized cohort', 'Baseline sociodemographic, patient-reported outcome, clinical history, and prostate cancer biopsy data were collected for all patients eligible to take part in the ProtecT trial, in a comprehensive cohort design', '2,664 men with clinically localized prostate cancer, 997 (37%) rejected randomization']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}]",[],[],2664.0,0.0522736,Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer.,"[{'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK. Electronic address: jenny.donovan@bristol.ac.uk.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Opmeer', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.036']
722,31778446,Ocular surface changes in the treatment of rosacea: comparison between low-dose oral isotretinoin and doxycycline.,"PURPOSE


To compare the impact of ocular changes between systemic treatment with doxycycline and low-dose oral isotretinoin in patients with moderate-to-severe papulopustular rosacea.
METHODS


Patients were randomized to receive either isotretinoin 0.3-0.4 mg/kg (group A) or doxycycline 100 mg/day (group B) for 16 weeks. Ocular symptoms were searched and evaluated, including best-corrected visual acuity (BCVA), Schirmer test, breakup time, rose bengal staining score, and meibomian gland dysfunction grading. The patients were retested at the end of treatment.
RESULTS


The present study included 39 patients (30 females and 9 males). Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment. After treatment, improvement in ocular symptoms and meibomian gland dysfunction was more pronounced in group B (p<0.05); the other parameters did not reach statistical significance.
CONCLUSION


Doxycycline improved meibomian gland dysfunction, ocular symptoms, and ocular surface in patients with rosacea. Even though some patients experienced worsening meibomian gland dysfunction and symptoms, no subject experienced any serious complications after administration of low-dose isotretinoin.",2020,Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment.,"['Patients', '39 patients (30 females and 9 males', 'patients with moderate-to-severe papulopustular rosacea', 'patients with rosacea', 'rosacea']","['doxycycline', 'doxycycline and low-dose oral isotretinoin', 'isotretinoin 0.3-0.4 mg/kg (group A) or doxycycline', 'Doxycycline']","['ocular symptoms and meibomian gland dysfunction', 'best-corrected visual acuity (BCVA), Schirmer test, breakup time, rose bengal staining score, and meibomian gland dysfunction grading', 'meibomian gland dysfunction, ocular symptoms, and ocular surface', 'Best-corrected visual acuity', 'Ocular symptoms', 'worsening meibomian gland dysfunction and symptoms', 'serious complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035857', 'cui_str': 'Rose Bengal'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",39.0,0.0566852,Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment.,"[{'ForeName': 'Fabio Mendonça Xavier', 'Initials': 'FMX', 'LastName': 'Andrade', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fabiola Rosa', 'Initials': 'FR', 'LastName': 'Picosse', 'Affiliation': 'Department of Dermatology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Laura Pires da', 'Initials': 'LPD', 'LastName': 'Cunha', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila Maia', 'Initials': 'CM', 'LastName': 'Valente', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda Machado', 'Initials': 'FM', 'LastName': 'Bezerra', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Miot', 'Affiliation': 'Department of Dermatology, Universidade Estadual Paulista ""Julio de Mesquita Filho"", São Paulo, SP, Brazil.'}, {'ForeName': 'Edileia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Department of Dermatology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Denise de', 'Initials': 'D', 'LastName': 'Freitas', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200016']
723,30448936,The influence of exercise training dose on fasting acylated ghrelin concentration in older women.,"This study investigated if exercise dose affected acylated ghrelin response to exercise training, and how body weight or fat mass changes might affect the responses. Non-obese older women (n = 49) were randomly assigned to 4-month moderate-intensity aerobic exercise of one of two doses (8 or 14 kcal kg -1  body weight weekly). Following exercise training, fasting acylated ghrelin concentrations changed differently between the two groups (p for group × time interaction = 0.050). It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group. Adjustment for weight or fat changes did not affect these results. Therefore, exercise training dose can have specific effects on acylated ghrelin that are not dependent on weight or fat loss. However, whether the different acylated ghrelin changes are associated with differing degree of subsequent weight maintenance worth further investigation.",2019,"It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group.","['Non-obese older women (n\u2009=\u200949', 'older women']","['exercise training', 'moderate-intensity aerobic exercise']","['weight or fat changes', 'fasting acylated ghrelin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",49.0,0.0275274,"It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group.","[{'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Bowyer', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Carson', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA. xwang@sc.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9990-z']
724,30660644,Allergen challenge increases capsaicin-evoked cough responses in patients with allergic asthma.,"BACKGROUND


Cough is a common and troublesome symptom in asthmatic patients, but little is known about the neuronal pathways that trigger cough. The mechanisms by which airway inflammation, airway hyperresponsiveness, and variable airflow obstruction cause cough are unclear.
OBJECTIVE


We sought to investigate the effects of allergen exposure on cough reflex sensitivity.
METHODS


We performed a 9-visit, randomized, single-blind, placebo-controlled, 2-way crossover study comparing cough responses to inhaled capsaicin in patients with mild atopic asthma after allergen challenge compared with diluent control. Full-dose capsaicin challenge was performed at screening to determine the capsaicin dose inducing a half-maximal response, which was subsequently administered at 30 minutes and 24 hours after inhaled allergen/diluent challenge. Spontaneous coughing was measured for 24 hours after allergen/diluent. Methacholine challenge and sputum induction were performed before and after allergen/diluent challenge.
RESULTS


Twelve steroid-naive subjects completed the study (6 female subjects; mean age, 34.8 years). Allergen inhalation caused both an early (mean ± SD, 38.2% ± 13.0%) and late (mean ± SD, 23.7% ± 13.2%) decrease in FEV 1  and an increase in sputum eosinophil counts 24 hours later (after diluent: median, 1.9% [interquartile range, 0.8% to 5.8%]; after allergen: median, 14.9% [interquartile range, 8.9% to 37.3%]; P = .005). There was also an increase in capsaicin-evoked coughs after allergen exposure compared with diluent at both 30 minutes (geometric mean coughs, 21.9 [95% CI, 16.5-29.20] vs 12.1 [95% CI, 8.3-17.7]; P < .001) and 24 hours (geometric mean coughs, 16.1 [95% CI, 11.3-23.0] vs 9.8 [95% CI, 6.1-15.8]; P = .001). Allergen exposure was also associated with an increase in spontaneous coughs over 24 hours.
CONCLUSION


Allergen-induced bronchoconstriction and airway eosinophilia result in increased cough reflex sensitivity to capsaicin associated with an increase in 24-hour spontaneous coughing.",2019,"There was also an increase in capsaicin-evoked coughs after allergen exposure compared with diluent at both 30 minutes (geometric mean coughs, 21.9 [95% CI, 16.5-29.20] vs 12.1 [95% CI, 8.3-17.7]; P < .001) and 24 hours (geometric mean coughs, 16.1 [95% CI, 11.3-23.0] vs 9.8 [95% CI, 6.1-15.8]; P = .001).","['patients with mild atopic asthma after allergen challenge', 'Twelve steroid-naive subjects completed the study (6 female subjects; mean age, 34.8\xa0years', 'patients with allergic asthma', 'asthmatic patients']","['diluent control', 'placebo', 'capsaicin', 'inhaled capsaicin']","['Spontaneous coughing', 'sputum eosinophil counts', 'capsaicin-evoked cough responses', 'Methacholine challenge and sputum induction', 'capsaicin-evoked coughs', '24-hour spontaneous coughing', 'spontaneous coughs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0430567', 'cui_str': 'Methacholine challenge (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",6.0,0.107566,"There was also an increase in capsaicin-evoked coughs after allergen exposure compared with diluent at both 30 minutes (geometric mean coughs, 21.9 [95% CI, 16.5-29.20] vs 12.1 [95% CI, 8.3-17.7]; P < .001) and 24 hours (geometric mean coughs, 16.1 [95% CI, 11.3-23.0] vs 9.8 [95% CI, 6.1-15.8]; P = .001).","[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Satia', 'Affiliation': 'Department of Medicine, Division of Respirology, McMaster University, Hamilton, Ontario, Canada; Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Watson', 'Affiliation': 'Department of Medicine, Division of Respirology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Scime', 'Affiliation': 'Department of Medicine, Division of Respirology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Dockry', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom; NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom; NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Ford', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom; NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Mitchell', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Fowler', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom; NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Gauvreau', 'Affiliation': 'Department of Medicine, Division of Respirology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': ""O'Byrne"", 'Affiliation': 'Department of Medicine, Division of Respirology, McMaster University, Hamilton, Ontario, Canada; Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and the Manchester Academic Health Science Centre, Manchester, United Kingdom; NHS Foundation Trust, University of Manchester, Manchester, United Kingdom. Electronic address: jacky.smith@manchester.ac.uk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.11.050']
725,32157328,Effectiveness of transdermal nicotine patch in premenopausal female smokers is moderated by within-subject severity of negative affect and physical symptoms.,"RATIONALE


Nicotine patches may be less effective in female compared with male smokers. However, it is unknown if negative affect and physical symptoms influence transdermal nicotine patch-related effects on smoking behaviors.
METHODS


Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal) and were randomized to patch condition (nicotine [21 mg] vs. placebo [0 mg] transdermal patch). Negative affect and physical symptoms were assessed prior to patch administration. The patch was removed 5 h post-administration, and participants completed a smoking reinstatement task. Multilevel linear models tested associations of patch condition, negative affect and physical symptoms, and their interaction on smoking behavior.
RESULTS


There was a significant patch condition × Negative Affect and Pain symptoms interaction on the number of cigarettes smoked (p < 0.05). When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual. There was also a significant patch condition × Negative Affect interaction on time delay. The effects of patch condition on time delay to smoking were greater during sessions in which Negative Affect was higher-than-usual.
CONCLUSIONS


Results suggest that among female smokers transdermal nicotine patch effectiveness may interact with negative affect and pain. Understanding and considering female-specific factors that may impact the efficacy of one of the most commonly used cessation medications is important for improving smoking cessation in female smokers.",2020,"When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual.","['Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal', 'premenopausal female smokers', 'female compared with male smokers', 'female smokers']","['transdermal nicotine', 'transdermal nicotine patch', 'patch condition (nicotine [21\xa0mg] vs. placebo [0\xa0mg] transdermal patch']","['time delay to smoking', 'time delay', 'Pain', 'Pain symptoms interaction', 'Negative affect and physical symptoms']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",81.0,0.0122859,"When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual.","[{'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Chai', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Tory A', 'Initials': 'TA', 'LastName': 'Eisenlohr-Moul', 'Affiliation': 'Department of Psychiatry, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Rapkin', 'Affiliation': 'Department of Obstetrics and Gynecology, Center for the Health Sciences, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': ""D'Orazio"", 'Affiliation': 'Department of Neurology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA. rpang@usc.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05494-z']
726,31309387,Meta-analysis of two randomized phase III trials (TCOG GI-0801 and ECRIN TRICS) of biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer.,"BACKGROUND


Biweekly irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in a second-line setting. We conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients enrolled two randomized phase III trials.
PATIENTS AND METHODS


Individual patient-level data from two randomized phase III trials were collected for this study. In both trials, patients with AGC refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m 2 ; CDDP, 30 mg/m 2 , q2w) or to CPT-11 (150 mg/m 2 , q2w).
RESULTS


Cumulative data from 290 eligible patients were evaluated. The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035). The response rate was 20.5% in the BIRIP group and 16.0% in the CPT-11 group (P = 0.361). However, the disease control rate was significantly better in the BIRIP group (72.1%) than in the CPT-11 group (59.2%) (P = 0.032). The two groups did not differ significantly in the incidences of grade 3 or worse adverse events.
CONCLUSIONS


Both BIRIP and CPT-11 may be good therapeutic options for patients with AGC as second-line treatment.
CLINICAL TRIAL REGISTRATION


UMIN 000025367.",2020,"The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035).","['290 eligible patients were evaluated', 'Individual patient-level data from two randomized phase III trials', 'patients with AGC', 'patients with AGC refractory to S-1-based chemotherapy', 'patients enrolled two randomized phase III trials', 'advanced gastric cancer']","['BIRIP (CPT-11, 60\xa0mg/m 2 ; CDDP, 30\xa0mg/m 2 , q2w) or to CPT-11', 'irinotecan plus cisplatin versus irinotecan alone', 'irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone']","['response rate', 'PFS', 'incidences of grade 3 or worse adverse events', 'efficacy and safety', 'disease control rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C4317169', 'cui_str': 'CPT-11'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",290.0,0.0966734,"The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035).","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006, Japan. kazuno13@hotmail.co.jp.'}, {'ForeName': 'Wasaburo', 'Initials': 'W', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Kitasato University East Hospital, 2-1-1, Asamizodai, Minami-ku, Sagamihara, Kanagawa, 252-0380, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': 'Department of Surgery, Ozawa Hospital, 1-1-17, Honcho, Odawara, 250-0012, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8397, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, 3-1-18, Jyonan, Ikeda, Osaka, 563-0025, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology Showa University Koto Totosu Hospital, 5-1-38 Toyosu, Koto-ku, Tokyo, 135-8577, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hosaka', 'Affiliation': 'Department of Gastroenterology, Gunma Prefectural Cancer Center, 617-1, Takahayashinishi-cho, Ohta, 373-0828, Japan.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama, 241-0815, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Department of Surgery, Kaizuka City Hospital, 3-10-20, Hori, Kaizuka, 597-0015, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, 4-6-2, Sohara Higashijimacho, Kakamigahara, 504-8601, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-019-00990-4']
727,31353217,"Efficacy and safety of intermittent preventive treatment and intermittent screening and treatment versus single screening and treatment with dihydroartemisinin-piperaquine for the control of malaria in pregnancy in Indonesia: a cluster-randomised, open-label, superiority trial.","BACKGROUND


Plasmodium falciparum and Plasmodium vivax infections are important causes of adverse pregnancy outcomes in the Asia-Pacific region. We hypothesised that monthly intermittent preventive treatment (IPT) or intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine is more effective in reducing malaria in pregnancy than the existing single screening and treatment (SST) strategy, which is used to screen women for malaria infections at the first antenatal visit followed by passive case detection, with management of febrile cases.
METHODS


We did an open-label, three-arm, cluster-randomised, superiority trial in Sumba (low malaria transmission site) and Papua (moderate malaria transmission site), Indonesia. Eligible participants were 16-30 weeks pregnant. Clusters (antenatal clinics with at least ten new pregnancies per year matched by location, size, and malaria risk) were randomly assigned (1:1:1) via computer-generated lists to IPT, IST, or SST clusters. In IPT clusters, participants received the fixed-dose combination of dihydroartemisinin-piperaquine (4 and 18 mg/kg per day). In IST clusters, participants were screened with malaria rapid diagnostic tests once a month, whereas, in SST clusters, they were screened at enrolment only. In all groups, participants with fever were tested for malaria. Any participant who tested positive received dihydroartemisinin-piperaquine regardless of symptoms. The primary outcome was malaria infection in the mother at delivery. Laboratory staff were unaware of group allocation. Analyses included all randomly assigned participants contributing outcome data and were adjusted for clustering at the clinic level. This trial is complete and is registered with ISRCTN, number 34010937.
FINDINGS


Between May 16, 2013, and April 21, 2016, 78 clusters (57 in Sumba and 21 in Papua) were randomly assigned to SST, IPT, or IST clusters (26 clusters each). Of 3553 women screened for eligibility, 2279 were enrolled (744 in SST clusters, 681 in IPT clusters, and 854 in IST clusters). At enrolment, malaria prevalence was lower in IST (5·7%) than in SST (12·6%) and IPT (10·6%) clusters. At delivery, malaria prevalence was 20·2% (128 of 633) in SST clusters, compared with 11·6% (61 of 528) in IPT clusters (relative risk [RR] 0·59, 95% CI 0·42-0·83, p=0·0022) and 11·8% (84 of 713) in IST clusters (0·56, 0·40-0·77, p=0·0005). Conditions related to the pregnancy, the puerperium, and the perinatal period were the most common serious adverse events for the mothers, and infections and infestations for the infants. There were no differences between groups in serious adverse events in the mothers or in their infants.
INTERPRETATION


IST was associated with a lower prevalence of malaria than SST at delivery, but the prevalence of malaria in this group was also lower at enrolment, making interpretation of the effect of IST challenging. Further studies with highly sensitive malaria rapid diagnostic tests should be considered. Monthly IPT with dihydroartemisinin-piperaquine is a promising alternative to SST in areas in the Asia-Pacific region with moderate or high transmission of malaria.
FUNDING


Joint Global Health Trials Scheme of the Medical Research Council, Department for International-Development, and the Wellcome Trust.",2019,"There were no differences between groups in serious adverse events in the mothers or in their infants.
","['3553 women screened for eligibility, 2279 were enrolled (744 in SST clusters, 681 in IPT clusters, and 854 in IST clusters', 'Clusters (antenatal clinics with at least ten new pregnancies per year matched by location, size, and malaria risk', 'Eligible participants were 16-30 weeks pregnant', 'participants with fever were tested for malaria', 'Between May 16, 2013, and April 21, 2016, 78 clusters (57 in Sumba and 21 in Papua', 'malaria in pregnancy in Indonesia']","['intermittent preventive treatment and intermittent screening and treatment versus single screening and treatment with dihydroartemisinin-piperaquine', 'monthly intermittent preventive treatment (IPT) or intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine', 'dihydroartemisinin-piperaquine']","['malaria prevalence', 'serious adverse events', 'Efficacy and safety', 'malaria infection in the mother at delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0454741', 'cui_str': 'Sumba (geographic location)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",2279.0,0.251284,"There were no differences between groups in serious adverse events in the mothers or in their infants.
","[{'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Jeanne R', 'Initials': 'JR', 'LastName': 'Poespoprodjo', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia; Timika Malaria Research Programme, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pace', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Lukito', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Sylvia S', 'Initials': 'SS', 'LastName': 'Maratina', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Santana-Morales', 'Affiliation': 'Department of Obstetrics and Gynecology, Pediatrics, Preventive Medicine and Public Health, Toxicology, Legal and Forensic Medicine and Parasitology, University Institute of Tropical Diseases and Public Health of the Canary Islands, University of la Laguna, Tenerife, Spain; Network Biomedical Research on Tropical Diseases, RICET, Madrid, Spain.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Adams', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Vera T', 'Initials': 'VT', 'LastName': 'Unwin', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Williams', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Smedley', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Faragher', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Price', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: feiko.terkuile@lstmed.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30156-2']
728,31113455,"Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study.","BACKGROUND


To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA).
METHODS


This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100.
RESULTS


A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively).
CONCLUSIONS


Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02715908 . Registered 22 March 2016.",2019,The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group).,"['148 patients entered this extension study (70 in the maintenance group and 78 in the switch group', 'patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis continuing on an']","['LBEC0101 vs ETN-RP', 'methotrexate', 'ETN-RP', 'etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101', 'LBEC0101']","['ACR response rates', 'sustained efficacy and acceptable safety', 'antidrug antibodies', '28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR', 'incidence of adverse events', 'Efficacy, safety and immunogenicity of LBEC0101']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C4705457', 'cui_str': 'LBEC0101'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4705457', 'cui_str': 'LBEC0101'}]",148.0,0.153637,The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group).,"[{'ForeName': 'Min-Chan', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Matsuno', 'Affiliation': 'Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Jinseok', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Jeju National University Hospital, Jeju, South Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': ""Division of Rheumatology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Sang-Heon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yong-Beom', 'Initials': 'YB', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yun Jong', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Dong Hyuk', 'Initials': 'DH', 'LastName': 'Sheen', 'Affiliation': 'Division of Rheumatology, Eulji University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jung-Yoon', 'Initials': 'JY', 'LastName': 'Choe', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Chan-Bum', 'Initials': 'CB', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Hanyang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Chang-Hee', 'Initials': 'CH', 'LastName': 'Suh', 'Affiliation': 'Department of Rheumatology, Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Shin-Seok', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, South Korea.'}, {'ForeName': 'Hoon-Suk', 'Initials': 'HS', 'LastName': 'Cha', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Division of Rheumatology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jin-Wuk', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Department of Internal Medicine, Eulji University College of Medicine, Eulji Hospital, Seoul, South Korea.'}, {'ForeName': 'Geun-Tae', 'Initials': 'GT', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Kosin University Gospel Hospital, Busan, South Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Yoo', 'Affiliation': 'Division of Rheumatology, Chonbuk National University Hospital, Jeonju, South Korea.'}, {'ForeName': 'Han Joo', 'Initials': 'HJ', 'LastName': 'Baek', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Kichul', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Division of Rheumatology, Seoul Metropolitan Government-Seoul National University, Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seung Cheol', 'Initials': 'SC', 'LastName': 'Shim', 'Affiliation': 'Division of Rheumatology, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Hyung-In', 'Initials': 'HI', 'LastName': 'Yang', 'Affiliation': 'Division of Rheumatology, Kyung Hee University Hospital at Gangdong, Oriental Hospital, Seoul, South Korea.'}, {'ForeName': 'Hyun Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Hallym University Sacred Heart Hospital, Kyunggi, South Korea.'}, {'ForeName': 'Kyung-Su', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': ""Division of Rheumatology, The Catholic University of Korea, St. Vincent's Hospital, Seoul, South Korea.""}, {'ForeName': 'In Ah', 'Initials': 'IA', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tomomitsu', 'Affiliation': 'Mochida Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Seonghye', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'LG Chem Ltd., Seoul, South Korea.'}, {'ForeName': 'Jiyoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'LG Chem Ltd., Seoul, South Korea.'}, {'ForeName': 'Yeong Wook', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Jongno-gu, Seoul, 03080, South Korea. ysong@snu.ac.kr.'}]",Arthritis research & therapy,['10.1186/s13075-019-1910-2']
729,30845329,"Assessing the Impact of a Vi-polysaccharide Conjugate Vaccine in Preventing Typhoid Infections Among Nepalese Children: A Protocol for a Phase III, Randomized Control Trial.","BACKGROUND


Enteric fever is estimated to affect 11-20 million people worldwide each year. Morbidity and mortality from enteric fever primarily occur in lower-income countries, with children under 5 years of age experiencing a significant portion of the burden. Over the last few decades, the control of enteric fever has focused primarily on improved water and sanitation, with the available vaccines unsuitable for children and primarily used by travelers. A new typhoid conjugate vaccine (Vi-TCV), prequalified by the World Health Organization (WHO) and highly immunogenic in children under 5, has the potential to reduce the typhoid burden in endemic countries.
METHODS


This study is a double-blinded, randomized, controlled trial with a 2-year follow-up to assess the protective impact of the Vi-TCV vaccine, compared with a control vaccine, in children from 9 months to 16 years of age. The primary outcome of interest is the reduction in the number of culture-confirmed typhoid cases attributable to Vi-TCV. Approximately 20 000 children living in the Lalitpur district, within the Kathmandu valley, will be enrolled in the study and followed to measure both safety and efficacy data, which will include adverse events, hospitalizations, antibiotic use, and fever frequency.
RESULTS


Both the intervention and control vaccines are WHO prequalified vaccines, which provide a health benefit to all participants. Children have been chosen to participate because they bear a substantial burden of both typhoid morbidity and mortality in this population. The results of this study will be disseminated through a series of published articles. The findings will also be made available to the participants and the broader community, as well as local stakeholders, within Nepal.
CONCLUSIONS


This is the first large-scale, individually randomized, controlled trial of Vi-TCV in children in an endemic setting, and will provide new data on Vi-TCV field efficacy. With Vi-TCV introduction being considered in high-burden countries, this study will support important policy decisions.
CLINICAL TRIALS REGISTRATION


The trial is registered on the ISRCTN registry (for details, see https://doi.org/10.1186/ISRCTN43385161; registry number: ISRCTN 43385161).",2019,The primary outcome of interest is the reduction in the number of culture-confirmed typhoid cases attributable to Vi-TCV.,"['Approximately 20 000 children living in the Lalitpur district, within the Kathmandu valley', 'Nepalese Children', 'children in an endemic setting', 'children from 9 months to 16 years of age']","['control vaccine', 'Vi-TCV', 'Vi-TCV vaccine', 'typhoid conjugate vaccine (Vi-TCV', 'Vi-polysaccharide Conjugate Vaccine']","['number of culture-confirmed typhoid cases attributable to Vi-TCV', 'adverse events, hospitalizations, antibiotic use, and fever frequency', 'Morbidity and mortality', 'Typhoid Infections']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.433286,The primary outcome of interest is the reduction in the number of culture-confirmed typhoid cases attributable to Vi-TCV.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Theiss-Nyland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Shakya', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Abhilasha', 'Initials': 'A', 'LastName': 'Karkey', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Hospital, Kathmandu.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Dongol', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Hospital, Kathmandu.'}, {'ForeName': 'Dikshya', 'Initials': 'D', 'LastName': 'Pant', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Hospital, Kathmandu.'}, {'ForeName': 'Yama G', 'Initials': 'YG', 'LastName': 'Farooq', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland, Baltimore, MD.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Paediatric Research Unit, Patan Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Hospital, Kathmandu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1106']
730,30845330,"A Phase II, Randomized, Double-blind, Controlled Safety and Immunogenicity Trial of Typhoid Conjugate Vaccine in Children Under 2 Years of Age in Ouagadougou, Burkina Faso: A Methods Paper.","The recent Typhoid Fever Surveillance in Africa Program demonstrated an overall adjusted incidence of typhoid fever 2-3 times higher than previous estimates in Africa. Recently, a single-dose typhoid conjugate vaccine that allows infants as young as 6 months old to be vaccinated was prequalified by the World Health Organization (WHO). This Vi-based conjugate vaccine demonstrated robust immunogenicity after 1 dose in infants and children 6 through 23 months of age in India with no safety signal, and is currently being tested for the first time on the African continent in Malawi. The WHO Strategic Advisory Group of Experts recommends studies to evaluate co-administering Vi-typhoid conjugate vaccine (Vi-TCV) with routine childhood vaccines in typhoid-endemic countries. The Burkina Faso immunization schedule includes yellow fever vaccine (YFV) at 9 months and meningococcal A conjugate vaccine (MCV-A) at 15 months, in addition to measles-rubella vaccine at both 9 and 15 months. Co-administration testing of Vi-TCV with these routine vaccinations will provide the data needed to support large-scale uptake of Vi-TCV in sub-Saharan Africa. A randomized, controlled, Phase II trial of Vi-TCV co-administration with the vaccinations routinely given at 9 and 15 months of age is planned in Burkina Faso. The overall aim is to assess the safety and immunogenicity of Vi-TCV when co-administered with YFV at 9 months of age and with MCV-A at 15 months of age. A total of 250 participants (100 infants aged 9-11 months and 150 children aged 15-23 months) will be enrolled. Clinical Trials Registration. NCT03614533.",2019,"This Vi-based conjugate vaccine demonstrated robust immunogenicity after 1 dose in infants and children 6 through 23 months of age in India with no safety signal, and is currently being tested for the first time on the African continent in Malawi.","['Children', '250 participants (100 infants aged 9-11 months and 150 children aged 15-23 months', 'typhoid-endemic countries', 'Under 2 Years of Age in Ouagadougou, Burkina Faso']","['Vi-TCV', 'co-administering Vi-typhoid conjugate vaccine (Vi-TCV', 'Typhoid Conjugate Vaccine', 'typhoid conjugate vaccine']",['safety and immunogenicity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",250.0,0.439004,"This Vi-based conjugate vaccine demonstrated robust immunogenicity after 1 dose in infants and children 6 through 23 months of age in India with no safety signal, and is currently being tested for the first time on the African continent in Malawi.","[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sodiomon B', 'Initials': 'SB', 'LastName': 'Sirima', 'Affiliation': 'Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rotrosen', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Mohamadou', 'Initials': 'M', 'LastName': 'Siribie', 'Affiliation': 'Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Tiono', 'Affiliation': 'Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Ouedraogo', 'Affiliation': 'Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology and Public Health University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Leslie P', 'Initials': 'LP', 'LastName': 'Jamka', 'Affiliation': 'Department of Epidemiology and Public Health University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Kotloff', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1104']
731,30845335,"Logistics of Implementing a Large-scale Typhoid Vaccine Trial in Kathmandu, Nepal.","Typhoid fever is estimated to affect over 20 million people per year worldwide, with infants, children, and adolescents in south-central and southeast Asia experiencing the greatest burden of disease. The Typhoid Vaccine Acceleration Consortium (TyVAC) aims to support the introduction of typhoid conjugate vaccines into Gavi-eligible countries in an effort to reduce morbidity and mortality from typhoid. TyVAC-Nepal is a large-scale, participant- and observer-blind, individually randomized, controlled trial evaluating the efficacy of a newly developed typhoid conjugate vaccine in an urban setting in Nepal. In order to effectively deliver the trial, a number of key elements required meticulous planning. Public engagement strategies were considered early, and involved the implementation of a tiered approach. Approximately 300 staff were employed and trained in order to achieve the mass vaccination of 20 000 children aged 9 months to ≤16 years old over a 4-month period. There were 19 vaccination clinics established across the Lalitpur metropolitan city in the Kathmandu valley. Participants will be followed for 2 years post-vaccination to measure the rate reduction of blood culture-confirmed typhoid fever in the vaccination arm as compared to the control arm. The experience of conducting this large-scale vaccine trial suggests that comprehensive planning, continuous monitoring, and an ability to adapt plans in response to feedback are key.",2019,Participants will be followed for 2 years post-vaccination to measure the rate reduction of blood culture-confirmed typhoid fever in the vaccination arm as compared to the control arm.,"['urban setting in Nepal', '19 vaccination clinics established across the Lalitpur metropolitan city in the Kathmandu valley', '20 000 children aged 9 months to ≤16 years old over a 4-month period']","['Typhoid Vaccine Acceleration Consortium (TyVAC', 'typhoid conjugate vaccine']","['rate reduction of blood culture-confirmed typhoid fever', 'Typhoid fever']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0338051', 'cui_str': 'Vaccination clinic (environment)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0041469', 'cui_str': 'Vaccines, Typhoid'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}]",20000.0,0.169622,Participants will be followed for 2 years post-vaccination to measure the rate reduction of blood culture-confirmed typhoid fever in the vaccination arm as compared to the control arm.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Shakya', 'Affiliation': 'Oxford University Clinical research Unit - Nepal.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Theiss-Nyland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Dikshya', 'Initials': 'D', 'LastName': 'Pant', 'Affiliation': 'Oxford University Clinical research Unit - Nepal.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tonks', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mazur', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Yama G', 'Initials': 'YG', 'LastName': 'Farooq', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Nepal Family Development Foundation, Kathmandu.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Dongol', 'Affiliation': 'Oxford University Clinical research Unit - Nepal.'}, {'ForeName': 'Abhilasha', 'Initials': 'A', 'LastName': 'Karkey', 'Affiliation': 'Oxford University Clinical research Unit - Nepal.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Paediatric Research Unit, Patan Hospital.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Oxford University Clinical research Unit - Nepal.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1125']
732,31445097,Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens.,"BACKGROUND


Food allergies are a significant public health issue, and the only effective management option currently available is strict avoidance of all foods containing the allergen. In view of the practical impossibility of limiting risks to zero, quantitative allergen risk assessment and management strategies are needed.
OBJECTIVE


We sought to develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders but particularly patients with food allergy.
METHODS


Individual thresholds for food allergens (maximum tolerable doses and minimum eliciting doses) can ideally be established through double-blind, placebo-controlled food challenges. If double-blind, placebo-controlled food challenge data are not available, data from widely used open food challenges using predefined objective criteria can also provide useful data regarding minimum eliciting doses. For more than 20 years, the Netherlands Organisation for Applied Scientific Research and the Food Allergy Research and Resource Program at the University of Nebraska-Lincoln have been collecting individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens.
RESULTS


In this article we provide in-depth insights into the methodology applied by the Netherlands Organisation for Applied Scientific Research and Food Allergy Research and Resource Program to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. More than 90 examples for determining individual allergic thresholds are presented.
CONCLUSION


With the methodology presented in this article, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption.",2019,"For more than 20 years, the Netherlands Organisation for Applied Scientific Research",[],['placebo-controlled food challenges (DBPCFCs'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",[],90.0,0.0781734,"For more than 20 years, the Netherlands Organisation for Applied Scientific Research","[{'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Westerhout', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), Zeist, The Netherlands.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Baumert', 'Affiliation': 'Food Allergy Research and Resource Program, Department of Food Science and Technology, University of Nebraska, Lincoln, Neb.'}, {'ForeName': 'W Marty', 'Initials': 'WM', 'LastName': 'Blom', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), Zeist, The Netherlands. Electronic address: marty.blom@tno.nl.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Allen', 'Affiliation': ""Murdoch Children's Research Institute and University of Melbourne School of Population and Global Health, Melbourne, Australia.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ballmer-Weber', 'Affiliation': 'Allergy Unit, Department of Dermatology, University Hospital, Zurich, Switzerland; Faculty of Medicine, University of Zurich, Zurich, Switzerland; Clinic for Dermatology and Allergology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'René W R', 'Initials': 'RWR', 'LastName': 'Crevel', 'Affiliation': 'René Crevel Consulting, Bedford, United Kingdom.'}, {'ForeName': 'Anthony E J', 'Initials': 'AEJ', 'LastName': 'Dubois', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pediatric Pulmonology and Pediatric Allergy, GRIAC Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Allergy Department, Hospital Clinico San Carlos, Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Greenhawt', 'Affiliation': ""Children's Hospital Colorado, School of Medicine, University of Colorado, Boulder, Colo.""}, {'ForeName': ""Jonathan O'B"", 'Initials': 'JO', 'LastName': 'Hourihane', 'Affiliation': 'INFANT Centre and Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Koplin', 'Affiliation': ""Murdoch Children's Research Institute and University of Melbourne School of Population and Global Health, Melbourne, Australia.""}, {'ForeName': 'Astrid G', 'Initials': 'AG', 'LastName': 'Kruizinga', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), Zeist, The Netherlands.'}, {'ForeName': 'Thuy-My', 'Initials': 'TM', 'LastName': 'Le', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Wayne G', 'Initials': 'WG', 'LastName': 'Shreffler', 'Affiliation': 'Food Allergy Centre and Centre for Immunology and Inflammatory Disease, and Massachusetts General Hospital/Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Section of Paediatrics, Imperial College London, London, United Kingdom; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Steve L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Food Allergy Research and Resource Program, Department of Food Science and Technology, University of Nebraska, Lincoln, Neb.'}, {'ForeName': 'Geert F', 'Initials': 'GF', 'LastName': 'Houben', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), Zeist, The Netherlands.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Remington', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), Zeist, The Netherlands.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.046']
733,30948516,Five-year costs from a randomised comparison of bilateral and single internal thoracic artery grafts.,"BACKGROUND


The use of bilateral internal thoracic arteries (BITA) for coronary artery bypass grafting (CABG) may improve survival compared with CABG using single internal thoracic arteries (SITA). We assessed the long-term costs of BITA compared with SITA.
METHODS


Between June 2004 and December 2007, 3102 patients from 28 hospitals in seven countries were randomised to CABG surgery using BITA (n=1548) or SITA (n=1554). Detailed resource use data were collected from the initial hospital episode and annually up to 5 years. The associated costs of this resource use were assessed from a UK perspective with 5 year totals calculated for each trial arm and pre-selected patient subgroups.
RESULTS


Total costs increased by approximately £1000 annually in each arm, with no significant annual difference between trial arms. Cumulative costs per patient at 5-year follow-up remained significantly higher in the BITA group (£18 629) compared with the SITA group (£17 480; mean cost difference £1149, 95% CI £330 to £1968, p=0.006) due to the higher costs of the initial procedure. There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events.
CONCLUSIONS


Higher index costs for BITA were still present at 5-year follow-up mainly driven by the higher initial cost with no subsequent difference emerging between 1 year and 5 years of follow-up. The overall cost-effectiveness of the two procedures, to be assessed at the primary endpoint of the 10-year follow-up, will depend on composite differences in costs and quality-adjusted survival.
TRIAL REGISTRATION NUMBER


ISRCTN46552265.",2019,"There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events.
","['n=1548) or SITA (n=1554', 'Between June 2004 and December 2007, 3102 patients from 28 hospitals in seven countries']","['CABG surgery using BITA', 'bilateral and single internal thoracic artery grafts', 'coronary artery bypass grafting (CABG', 'bilateral internal thoracic arteries (BITA']","['Total costs', 'cost associated with healthcare contacts, medication use or serious adverse events', 'Cumulative costs', 'costs and quality-adjusted survival', 'overall cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0226276', 'cui_str': 'Internal Mammary Artery'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",3102.0,0.2024,"There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Altman', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University of Bristol School of Clinical Science, Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, Oxford, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taggart', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-313932']
734,30755487,Epilepsy Gene Therapy Using an Engineered Potassium Channel.,"Refractory focal epilepsy is a devastating disease for which there is frequently no effective treatment. Gene therapy represents a promising alternative, but treating epilepsy in this way involves irreversible changes to brain tissue, so vector design must be carefully optimized to guarantee safety without compromising efficacy. We set out to develop an epilepsy gene therapy vector optimized for clinical translation. The gene encoding the voltage-gated potassium channel Kv1.1,  KCNA1 , was codon optimized for human expression and mutated to accelerate the recovery of the channels from inactivation. For improved safety, this engineered potassium channel (EKC) gene was packaged into a nonintegrating lentiviral vector under the control of a cell type-specific  CAMK2A  promoter. In a blinded, randomized, placebo-controlled preclinical trial, the EKC lentivector robustly reduced seizure frequency in a male rat model of focal neocortical epilepsy characterized by discrete spontaneous seizures. When packaged into an adeno-associated viral vector (AAV2/9), the EKC gene was also effective at suppressing seizures in a male rat model of temporal lobe epilepsy. This demonstration of efficacy in a clinically relevant setting, combined with the improved safety conferred by cell type-specific expression and integration-deficient delivery, identify EKC gene therapy as being ready for clinical translation in the treatment of refractory focal epilepsy. SIGNIFICANCE STATEMENT  Pharmacoresistant epilepsy affects up to 0.3% of the population. Although epilepsy surgery can be effective, it is limited by risks to normal brain function. We have developed a gene therapy that builds on a mechanistic understanding of altered neuronal and circuit excitability in cortical epilepsy. The potassium channel gene  KCNA1  was mutated to bypass post-transcriptional editing and was packaged in a nonintegrating lentivector to reduce the risk of insertional mutagenesis. A randomized, blinded preclinical study demonstrated therapeutic effectiveness in a rodent model of focal neocortical epilepsy. Adeno-associated viral delivery of the channel to both hippocampi was also effective in a model of temporal lobe epilepsy. These results support clinical translation to address a major unmet need.",2019,Adeno-associated viral delivery of the channel to both hippocampi was also effective in a model of temporal lobe epilepsy.,[],"['EKC lentivector', 'hippocampi', 'Engineered Potassium Channel', 'placebo']",['seizure frequency'],[],"[{'cui': 'C0014493', 'cui_str': 'EKC'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C0032824', 'cui_str': 'Potassium Channel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0544204,Adeno-associated viral delivery of the channel to both hippocampi was also effective in a model of temporal lobe epilepsy.,"[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Snowball', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Chabrol', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Wykes', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Shekh-Ahmad', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Cornford', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lieb', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Hughes', 'Affiliation': 'UCL School of Pharmacy, University College London, London WC1N 1AX, United Kingdom, and.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Massaro', 'Affiliation': 'UCL School of Pharmacy, University College London, London WC1N 1AX, United Kingdom, and.'}, {'ForeName': 'Ahad A', 'Initials': 'AA', 'LastName': 'Rahim', 'Affiliation': 'UCL School of Pharmacy, University College London, London WC1N 1AX, United Kingdom, and.'}, {'ForeName': 'Kevan S', 'Initials': 'KS', 'LastName': 'Hashemi', 'Affiliation': 'Open Source Instruments Inc., Watertown, Massachusetts 02472.'}, {'ForeName': 'Dimitri M', 'Initials': 'DM', 'LastName': 'Kullmann', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom, d.kullmann@ucl.ac.uk m.walker@ucl.ac.uk.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Walker', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom, d.kullmann@ucl.ac.uk m.walker@ucl.ac.uk.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schorge', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.1143-18.2019']
735,32155662,First-line therapy with bendamustine/prednisone/bortezomib-A GMMG trial for non-transplant eligible symptomatic multiple myeloma patients.,"OBJECTIVES


The German-speaking Myeloma Multicenter Group (GMMG) conducted this trial to investigate efficacy and safety of the three-drug combination bendamustine/prednisone/bortezomib (BPV) as first-line therapy for elderly patients with multiple myeloma (MM).
METHODS


Elderly MM patients requiring first-line therapy and not eligible for intensive treatment were enrolled in this phase IIb multicenter study. Patients were treated with BPV regimen for a maximum of nine cycles.
RESULTS


Forty-six patients were included in the trial with a median age of 76 years. Nineteen patients had renal impairment at baseline. The ORR was 78.8% for patients treated with 3 and more BPV cycles and 71.1% for all evaluable patients. The median progression-free survival was 25 months, and overall survival at 24 months was 83.3%. The clinical benefit rate including MR was 91.2%. In patients with renal impairment at baseline, a renal response was observed in 11 pts. with complete recovery of the renal function in six patients. The most frequent CTC grade 3/4 AEs experienced by patients were hematological (17.5%) and infectious (9.8%) complications. No new safety signals were observed for the study drugs under investigation.
CONCLUSIONS


Bendamustine/prednisone/bortezomib may serve as a first-line regimen for transplant-ineligible elderly MM patients in particular for patients with renal impairment requiring a fast and durable renal response.",2020,"The ORR was 76.5%, the median progression free survival 25 months and overall survival at 24 month 83.3%.","['elderly patients with multiple myeloma (MM', 'non-transplant eligible symptomatic multiple myeloma patients', '6 patients', '19 patients had renal impairment at baseline', 'Elderly MM patients requiring first-line therapy and not eligible for intensive treatment were enrolled in this phase IIb multicenter study', 'transplant ineligible elderly MM patients in particular for patients with renal impairment requiring a fast and durable renal response', '46 patients were included into the trial with a median age of 76 years']","['3-drug-combination bendamustine/prednisone/bortezomib (BPV', 'BPV', 'Bendamustine/Prednisone/Bortezomib (BPV) ']","['renal response', 'renal function', 'clinical benefit rate (CBR) including MR', 'ORR', 'median progression free survival 25 months and overall survival']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0013162', 'cui_str': 'Drug Combinations'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",46.0,0.0301331,"The ORR was 76.5%, the median progression free survival 25 months and overall survival at 24 month 83.3%.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Knauf', 'Affiliation': 'Centrum Haematologie & Onkologie Bethanien, Frankfurt, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Dingeldein', 'Affiliation': 'Onkologische Schwerpunktpraxis, Darmstadt, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': 'Hämatologisch-Onkologische Schwerpunktpraxis, Würzburg, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Welslau', 'Affiliation': 'Onkologische Praxis, Aschaffenburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Moehler', 'Affiliation': 'IQVIA, Frankfurt, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Terzer', 'Affiliation': 'Department of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Koordinierungszentrum für klinische Studien Heidelberg, FRG, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Habermehl', 'Affiliation': 'Department of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Department of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc-Steffen', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of haematology,['10.1111/ejh.13409']
736,31342329,Integrating a Medical Home in an Outpatient Dialysis Setting: Effects on Health-Related Quality of Life.,"BACKGROUND


Integrating primary care has been proposed to reduce fragmented care delivery for patients with complex medical needs. Because of their high rates of morbidity, healthcare use, and mortality, patients with end-stage kidney disease (ESKD) may benefit from increased access to a primary care medical home.
OBJECTIVE


To evaluate the effect of integrating a primary care medical home on health-related quality of life (HRQOL) for patients with ESKD receiving chronic hemodialysis.
DESIGN


Before-after intervention trial with repeated measures at two Chicago dialysis centers.
PARTICIPANTS


Patients receiving hemodialysis at either of the two centers.
INTERVENTION


To the standard hemodialysis team (nephrologist, nurse, social worker, dietitian), we added a primary care physician, a pharmacist, a nurse coordinator, and a community health worker. The intervention took place from January 2015 through August 2016.
MAIN MEASURES


Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures.
KEY RESULTS


Of 247 eligible patients, 175 (71%) consented and participated; mean age was 54 years; 55% were men and 97% were African American or Hispanic. In regression analysis adjusted for individual visits with the medical home providers and other factors, there were significant improvements in four of five KDQOL domains: at 12 and 18 months, the Mental Component Score improved from baseline (adjusted mean 49.0) by 2.64 (p = 0.01) and 2.96 (p = 0.007) points, respectively. At 6 and 12 months, the Symptoms domain improved from baseline (adjusted mean = 77.0) by 2.61 (p = 0.02) and 2.35 points (p = 0.05) respectively. The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively. The Physical Component Score improved at 6 months only.
CONCLUSIONS


Integrating primary care and enhancing care coordination in two dialysis facilities was associated with improvements in HRQOL among patients with ESKD who required chronic hemodialysis.",2019,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","['Patients receiving hemodialysis at either of the two centers', '175 (71%) consented and participated; mean age was 54\xa0years; 55% were men and 97% were African American or Hispanic', 'patients with ESKD who required chronic hemodialysis', 'patients with end-stage kidney disease (ESKD', 'patients with ESKD receiving chronic hemodialysis', '247 eligible patients', 'patients with complex medical needs']",[],"['Physical Component Score', 'Symptoms domain', 'Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures', 'Health-Related Quality of Life', 'Mental Component Score', 'health-related quality of life (HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",247.0,0.0347094,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","[{'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Hynes', 'Affiliation': 'College of Public Health and Human Sciences and Center for Genome Research and Biocomputing, Oregon State University, Corvallis, OR, USA. hynesd@oregonstate.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Porter', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ifeanyi B', 'Initials': 'IB', 'LastName': 'Chukwudozie', 'Affiliation': 'Office of Community Engaged Research and Implementation Science, University of Illinois Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Arruda', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05154-9']
737,31125276,"Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study.","PURPOSE


In PALOMA-2, palbociclib plus letrozole significantly improved progression-free survival (PFS) as initial treatment of estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. We assessed the benefit of palbociclib plus letrozole in Asians.
PATIENTS AND METHODS


Of 666 enrolled postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (no prior treatment of advanced disease), 95 were Asian. Patients were randomly assigned 2:1 to receive palbociclib plus letrozole or placebo plus letrozole. The primary end point was investigator-assessed PFS. Secondary end points were overall survival, objective response, patient-reported outcomes, pharmacokinetics, and safety.
RESULTS


Median PFS was significantly longer in Asian patients who received palbociclib plus letrozole versus placebo plus letrozole (25.7 months [95% CI, 19.2 months to not estimable]  v  13.9 months [95% CI, 7.4 to 22.0 months]; hazard ratio, 0.49; 95% CI, 0.27 to 0.87;  P  = .007). The most common toxicities with palbociclib were hematologic and more frequent among Asians versus non-Asians: neutropenia (any grade, 95.4%  v  76.8%; grade 3/4, 89.2%  v  62.5%), leukopenia (43.1%  v  38.3%; 32.3%  v  23.5%), and thrombocytopenia (27.7%  v  13.5%; 4.6%  v  1.1%). No Asians had febrile neutropenia. Discontinuation rates as a result of adverse events were similar among Asian and non-Asian patients who received palbociclib plus letrozole (10.8% and 9.5%). In Asians, quality of life (QOL) was maintained with no significant differences observed between treatments from baseline in breast cancer-specific QOL and general health status scores. Change from baseline in EuroQol five dimensions index scores was significantly higher with palbociclib plus letrozole (0.013  v  -0.069;  P  = .0132). Geometric mean palbociclib trough concentration values were higher in Asians versus non-Asians (93.8  v  61.7 ng/mL).
CONCLUSION


Consistent with the overall study population, the addition of palbociclib to letrozole significantly improved PFS in Asians. Hematologic toxicities were more frequent in Asians versus non-Asians but manageable with early dose modifications while maintaining QOL.",2019,Change from baseline in EuroQol five dimensions index scores was significantly higher with palbociclib plus letrozole (0.013  v  -0.069;  P  = .0132).,"['Asians', 'Of 666 enrolled postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (no prior treatment of advanced disease), 95 were Asian', 'Postmenopausal Asian Women With Metastatic Breast Cancer']","['placebo plus letrozole', 'palbociclib plus letrozole', 'palbociclib plus letrozole or placebo plus letrozole', 'Palbociclib Plus Letrozole', 'PALOMA-2, palbociclib plus letrozole', 'letrozole']","['leukopenia', 'progression-free survival (PFS', 'febrile neutropenia', 'Hematologic toxicities', 'overall survival, objective response, patient-reported outcomes, pharmacokinetics, and safety', 'Discontinuation rates', 'adverse events', 'Geometric mean palbociclib trough concentration values', 'investigator-assessed PFS', 'EuroQol five dimensions index scores', 'breast cancer-specific QOL and general health status scores', 'quality of life (QOL', 'thrombocytopenia', 'Median PFS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034380'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",666.0,0.149505,Change from baseline in EuroQol five dimensions index scores was significantly higher with palbociclib plus letrozole (0.013  v  -0.069;  P  = .0132).,"[{'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Gyeonggi-do, South Korea.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Hiroshima City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer, Collegeville, PA.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer, La Jolla, CA.'}, {'ForeName': 'Shrividya', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Pfizer Japan, Tokyo, Japan.'}, {'ForeName': 'Ave', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Pfizer Srl, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer, San Francisco, CA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}]",Journal of global oncology,['10.1200/JGO.18.00173']
738,30845320,"Typhoid Vaccine Acceleration Consortium Malawi: A Phase III, Randomized, Double-blind, Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine Among Children in Blantyre, Malawi.","BACKGROUND


Typhoid fever is an acute infection characterized by prolonged fever following the ingestion and subsequent invasion of Salmonella enterica serovar Typhi (S. Typhi), a human-restricted pathogen. The incidence of typhoid fever has been most reported in children 5-15 years of age, but is increasingly recognized in children younger than 5 years old. There has been a recent expansion of multidrug-resistant typhoid fever globally. Prior typhoid vaccines were not suitable for use in the youngest children in countries with a high burden of disease. This study aims to determine the efficacy of a typhoid conjugate vaccine (TCV) that was recently prequalified by the World Health Organization, by testing it in children 9 months through 12 years of age in Blantyre, Malawi.
METHODS


In this Phase III, individually randomized, controlled, double-blind trial of the clinical efficacy of TCV, 28 000 children 9 months through 12 years of age will be enrolled and randomized in a 1:1 ratio to receive either Vi-TCV or a meningococcal serogroup A conjugate vaccine. A subset of 600 of these children will be further enrolled in an immunogenicity and reactogenicity sub-study to evaluate the safety profile and immune response elicited by Vi-TCV. Recruiting began in February 2018.
RESULTS


All children will be under passive surveillance for at least 2 years to determine the primary outcome, which is blood culture-confirmed S. Typhi illness. Children enrolled in the immunogenicity and reactogenicity sub-study will have blood drawn before vaccination and at 2 timepoints after vaccination to measure their immune response to vaccination. They will also be followed actively for adverse events and serious adverse events.
CONCLUSIONS


The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places. This trial, the first of a TCV in Africa, seeks to demonstrate the impact and programmatic use of TCVs within an endemic setting.
CLINICAL TRIALS REGISTRATION


NCT03299426.",2019,"The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places.","['children 9 months through 12 years of age in Blantyre, Malawi', 'Children in Blantyre, Malawi', 'youngest children in countries with a high burden of disease', '28 000 children 9 months through 12 years of age', 'children younger than 5 years old']","['TCV', 'Typhoid Vaccine Acceleration Consortium Malawi', 'Vi-TCV or a meningococcal serogroup A conjugate vaccine', 'Typhoid Conjugate Vaccine', 'typhoid conjugate vaccine (TCV']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0041469', 'cui_str': 'Vaccines, Typhoid'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}]",[],28000.0,0.680111,"The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places.","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Meiring', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Oxford University, United Kingdom.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Pratiksha', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Misiri', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Simiyu', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Felistas', 'Initials': 'F', 'LastName': 'Mwakiseghile', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'J Kathleen', 'Initials': 'JK', 'LastName': 'Tracy', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Masesa', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Henrion', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rotrosen', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gmeiner', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heyderman', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kotloff', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Melita A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1103']
739,31921170,The Safety and Immunogenicity of GTU ® MultiHIV DNA Vaccine Delivered by Transcutaneous and Intramuscular Injection With or Without Electroporation in HIV-1 Positive Subjects on Suppressive ART.,"Previous studies have shown targeting different tissues via the transcutaneous (TC) and intramuscular injection (IM) with or without electroporation (EP) has the potential to trigger immune responses to DNA vaccination. The CUTHIVTHER 001 Phase I/II randomized controlled clinical trial was designed to determine whether the mode of DNA vaccination delivery (TC+IM or EP+IM) could influence the quality and function of induced cellular immune responses compared to placebo, in an HIV positive clade B cohort on antiretroviral therapy (ART). The GTU ® MultiHIV B DNA vaccine DNA vaccine encoded a MultiHIV B clade fusion protein to target the cellular response. Overall the vaccine and regimens were safe and well-tolerated. There were robust pre-vaccination IFN-γ responses with no measurable change following vaccination compared to placebo. However, modest intracellular cytokine staining (ICS) responses were seen in the TC+IM group. A high proportion of individuals demonstrated potent viral inhibition at baseline that was not improved by vaccination. These results show that HIV positive subjects with nadir CD4+ counts ≥250 on suppressive ART display potent levels of cellular immunity and viral inhibition, and that DNA vaccination alone is insufficient to improve such responses. These data suggest that more potent prime-boost vaccination strategies are likely needed to improve pre-existing responses in similar HIV-1 cohorts (This study has been registered at http://ClinicalTrials.gov under registration no. NCT02457689).",2019,There were robust pre-vaccination IFN-γ responses with no measurable change following vaccination compared to placebo.,"['HIV-1 Positive Subjects on Suppressive ART', 'HIV positive clade B cohort on antiretroviral therapy (ART']","['placebo', 'DNA vaccination delivery (TC+IM or EP+IM', 'transcutaneous (TC) and intramuscular injection (IM) with or without electroporation (EP', 'GTU ® MultiHIV DNA Vaccine Delivered by Transcutaneous and Intramuscular Injection With or Without Electroporation']","['potent viral inhibition', 'safe and well-tolerated', 'modest intracellular cytokine staining (ICS) responses']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}]",,0.195027,There were robust pre-vaccination IFN-γ responses with no measurable change following vaccination compared to placebo.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Haidari', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wood', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ridgers', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alethea V', 'Initials': 'AV', 'LastName': 'Cope', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Fleck', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Kalevi', 'Initials': 'K', 'LastName': 'Reijonen', 'Affiliation': 'FIT Biotech Ltd., Tampere, Finland.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems Inc, San Diego, CA, United States.'}, {'ForeName': 'Aggeliki', 'Initials': 'A', 'LastName': 'Spentzou', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hayes', 'Affiliation': 'Human Immunology Laboratory, International AIDS Vaccine Initiative, Imperial College London, London, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Behazine', 'Initials': 'B', 'LastName': 'Combadiere', 'Affiliation': ""Sorbonne Université, Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), INSERM U1135, Paris, France.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, University College London, London, United Kingdom.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, University College London, London, United Kingdom.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Shattock', 'Affiliation': 'Group of Mucosal Infection and Immunity, Department of Medicine, Imperial College London, London, United Kingdom.'}]",Frontiers in immunology,['10.3389/fimmu.2019.02911']
740,30738706,Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data.,"BACKGROUND


The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes.
METHODS


We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial.
FINDINGS


In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3).
INTERPRETATION


Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future.
FUNDING


None.",2019,"After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS.","['4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years', 'symptomatic carotid stenosis', 'Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial']","['CAS versus CEA', 'stenting and endarterectomy', 'CAS and CEA', 'carotid endarterectomy (CEA', 'CAS', 'carotid artery stenting (CAS', 'symptomatic carotid stenosis (Endarterectomy versus Angioplasty']","['annual rates of ipsilateral stroke per person-year', 'risk of ipsilateral stroke', 'composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke', 'Median length']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0411287', 'cui_str': 'Percutaneous transluminal balloon angioplasty (procedure)'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3495793', 'cui_str': 'Carotid revascularisation'}]","[{'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",4775.0,0.404534,"After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS.","[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calvet', 'Affiliation': 'Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, UAB School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Becquemin', 'Affiliation': 'Vascular Institute of Paris East, Hôspital Paul D Egine, Champigny-sur-Marne, France.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'de Borst', 'Affiliation': 'Department of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hans-Henning', 'Initials': 'HH', 'LastName': 'Eckstein', 'Affiliation': 'Department for Vascular and Endovascular Surgery-Vascular Center, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Fraedrich', 'Affiliation': 'Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jacoba P', 'Initials': 'JP', 'LastName': 'Greving', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Halliday', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hendrikse', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Jansen', 'Affiliation': 'Clinic for Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Jenifer H', 'Initials': 'JH', 'LastName': 'Voeks', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology, University of Heidelberg Medical School, Heidelberg, Germany.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Mas', 'Affiliation': 'Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Brown', 'Affiliation': 'Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Bonati', 'Affiliation': 'Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30028-6']
741,31135812,Association of Nonfasting vs Fasting Lipid Levels With Risk of Major Coronary Events in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm.,"Importance


Recent guidelines have recommended nonfasting for routine testing of lipid levels based on comparisons of nonfasting and fasting populations. However, no previous study has examined the association of cardiovascular outcomes with fasting vs nonfasting lipid levels measured in the same individuals.
Objective


To compare the association of nonfasting and fasting lipid levels with prospectively ascertained coronary and vascular outcomes and to evaluate whether a strategy of using nonfasting instead of fasting lipid level measurement would result in misclassification of risk for individuals undergoing evaluation for initiation of statin therapy.
Design, Setting, and Participants


This post hoc prospective follow-up of a randomized clinical trial included 8270 of 10 305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years). Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018. Multivariable Cox models, adjusted for cardiovascular risk factors, were calculated for 40-mg/dL (1-mmol/L) higher values of nonfasting and fasting lipids.
Main Outcomes and Measures


The trial's primary end point consisted of major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events]). Secondary analyses examined atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events]).
Results


Among the 8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years), nonfasting samples had modestly higher triglyceride levels and similar cholesterol levels compared to fasting samples. Associations of nonfasting lipid levels with coronary events were similar to those for fasting lipid levels. For example, adjusted hazard ratios (HRs) per 40-mg/dL of low-density lipoprotein cholesterol were 1.32 (95% CI, 1.08-1.61; P = .007) for nonfasting levels and 1.28 (95% CI, 1.07-1.55; P = .008) for fasting levels. For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels. Results were consistent by randomized treatment arm (atorvastatin calcium, 10 mg/d, or placebo) and similar for ASCVD events. Concordance of fasting and nonfasting lipid levels for classifying participants into appropriate ASCVD risk categories was high (94.8%).
Conclusions and Relevance


Measurement of nonfasting and fasting lipid levels yields similar results in the same individuals for association with incident coronary and ASCVD events. These results suggest that routine measurement of nonfasting lipid levels may help facilitate ASCVD risk screening and treatment, including consideration of when to initiate statin therapy.",2019,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","['individuals undergoing evaluation for initiation of statin therapy', 'Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018', '8270 of 10\u202f305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years', '8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years']","['atorvastatin calcium', 'placebo']","['atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events', 'major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events', 'Association of Nonfasting vs Fasting Lipid Levels', 'cardiovascular risk factors', 'Concordance of fasting and nonfasting lipid levels', 'low-density lipoprotein cholesterol', 'nonfasting lipid levels', 'triglyceride levels and similar cholesterol levels', 'nonfasting levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0286650', 'cui_str': 'Atorvastatin calcium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10305.0,0.0492221,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","[{'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'C Lan', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'M Vinayaga', 'Initials': 'MV', 'LastName': 'Moorthy', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0392']
742,31189670,What are the perceived target groups and occasions for wines and beers labelled with verbal and numerical descriptors of lower alcohol strength? An experimental study.,"OBJECTIVES


Alcohol consumption is the fifth leading cause of morbidity and mortality globally. The development and promotion of lower strength alcohol products may help reduce alcohol consumption and associated harms. This study assessed what a sample of UK weekly drinkers perceived to be the target groups and occasions for drinking wines and beers labelled with different verbal and numerical descriptors of lower alcohol strength.
DESIGN AND PARTICIPANTS


3390 adults (1697 wine and 1693 beer drinkers) were sampled from a nationally representative UK panel, and participated in a between-subjects experiment in which participants were randomised to 1 of 18 groups with one of three levels of verbal descriptor ( Low  vs.  Super Low  vs.  No verbal descriptor ) and six levels of %ABV (five levels varying for wine and beer, and no level given).
MEASURES


The study gauged participants' perceptions of the type of person that would find the randomised beverage appealing and the type of occasion on which the beverage is likely to be drunk at.
RESULTS


A principal component analysis showed that participants perceived pregnant women, sportspeople and those aged 6-13 years old were the target groups for products labelled with 0%ABV or the verbal descriptors  Low  or  Super Low , whereas men, women, and those aged above 18 were perceived as the target groups for products labelled with higher %ABV. Participants also rated the products labelled with 0%ABV or the verbal descriptors  Low  or  Super Low  as targeting consumption on weekday lunches, whereas products labelled with higher %ABV were rated as targeting dinner/evening occasions, including parties, holidays and celebrations.
CONCLUSIONS


Lower strength products were seen as targeting non-traditional consumers (pregnant women) and occasions (weekday lunchtimes), suggesting these products may be perceived as extensions to regular strength alcoholic drinks rather than as substitutes for them.",2019,"A principal component analysis showed that participants perceived pregnant women, sportspeople and those aged 6-13 years old were the target groups for products labelled with 0%ABV or the verbal descriptors  Low  or  Super Low , whereas men, women, and those aged above 18 were perceived as the target groups for products labelled with higher %ABV.","['3390 adults (1697 wine and 1693 beer drinkers) were sampled from a nationally representative UK panel, and participated in a between-subjects experiment in which participants', 'participants perceived pregnant women, sportspeople and those aged 6-13 years old']","['verbal descriptor ( Low  vs.  Super Low  vs.  No verbal descriptor ) and six levels of %ABV (five levels varying for wine and beer, and no level given']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0425330', 'cui_str': 'Beer drinker (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0282354', 'cui_str': 'Descriptors'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],3390.0,0.0449582,"A principal component analysis showed that participants perceived pregnant women, sportspeople and those aged 6-13 years old were the target groups for products labelled with 0%ABV or the verbal descriptors  Low  or  Super Low , whereas men, women, and those aged above 18 were perceived as the target groups for products labelled with higher %ABV.","[{'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Vasiljevic', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Dominique-Laurent', 'Initials': 'DL', 'LastName': 'Couturier', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2018-024412']
743,31213443,"Effects of a training programme of functional electrical stimulation (FES) powered cycling, recreational cycling and goal-directed exercise training on children with cerebral palsy: a randomised controlled trial protocol.","INTRODUCTION


Children with cerebral palsy (CP) experience declines in gross motor ability as they transition from childhood to adolescence, which can result in the loss of ability to perform sit-to-stand transfers, ambulate or participate in leisure activities such as cycling. Functional electrical stimulation (FES) cycling is a novel technology that may provide opportunities for children with CP to strengthen their lower limbs, improve functional independence and increase physical activity participation. The proposed randomised controlled trial will test the efficacy of a training package of FES cycling, adapted cycling and goal-directed functional training to usual care in children with CP who are susceptible to functional declines.
METHODS AND ANALYSIS


Forty children with CP (20 per group), aged 6-8 years and classified as Gross Motor Function Classification System (GMFCS) levels II-IV will be recruited across South East Queensland. Participants will be randomised to either an immediate intervention group, who will undertake 8 weeks of training, or a waitlist control group. The training group will attend two 1 hour sessions per week with a physiotherapist, consisting of FES cycling and goal-directed, functional exercises and a 1 hour home exercise programme per week, consisting of recreational cycling. Primary outcomes will be the gross motor function measure and Canadian occupational performance measure, and secondary outcomes will include the five times sit-to-stand test, habitual physical activity (accelerometry), power output during cycling and Participation and Environment Measure-Children and Youth. Outcomes will be assessed at baseline, postintervention (8 weeks) and 8 weeks following the intervention (retention).
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Griffith University (2018/037) and the Children's Health Queensland Hospital and Health Service (CHQHHS) Human Research Ethics Committee (HREC/17/QRCH/88). Site-specific approval was obtained from CHQHHS research governance (SSA/17/QRCH/145). Results from this trial will be disseminated via publication in relevant peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ACTRN12617000644369p.",2019,"Participants will be randomised to either an immediate intervention group, who will undertake 8 weeks of training, or a waitlist control group.","['children with cerebral palsy', ""Griffith University (2018/037) and the Children's Health Queensland Hospital and Health Service (CHQHHS"", 'Children with cerebral palsy (CP', 'children with CP', 'children with CP who are susceptible to functional declines', 'Forty children with CP (20 per group), aged 6-8 years and classified as Gross Motor Function Classification System (GMFCS) levels II-IV will be recruited across South East Queensland']","['training programme of functional electrical stimulation (FES) powered cycling, recreational cycling and goal-directed exercise training', 'Functional electrical stimulation (FES) cycling', 'FES cycling and goal-directed, functional exercises and a 1\u2009hour home exercise programme per week, consisting of recreational cycling', 'training package of FES cycling, adapted cycling and goal-directed functional training', 'immediate intervention group, who will undertake 8\u2009weeks of training, or a waitlist control group']","['gross motor function measure and Canadian occupational performance measure, and secondary outcomes will include the five times sit-to-stand test, habitual physical activity (accelerometry), power output during cycling and Participation and Environment Measure-Children and Youth']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0441926', 'cui_str': 'Level II (tumor staging)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",40.0,0.0943618,"Participants will be randomised to either an immediate intervention group, who will undertake 8 weeks of training, or a waitlist control group.","[{'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Armstrong', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Kentish', 'Affiliation': ""Queensland Paediatric Rehabilitation Service, Children's Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Carty', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Horan', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-024881']
744,30243810,"Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.","OBJECTIVE


Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other.
DESIGN


Randomized controlled trial.
SETTING


Academic medical centers.
PATIENTS


We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes.
INTERVENTIONS


Randomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial human chorionic gonadotropin (hCG) concentrations and/or additional ultrasonography.
MAIN OUTCOME


The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility.
CONCLUSION


This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.",2018,This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.,"['women who have persisting pregnancy of unknown location', 'women with a persisting pregnancy of unknown location', 'Academic medical centers', '276 persisting PUL-diagnosed women who are 18\u202fyears or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2\u202fyears for fertility and patient satisfaction outcomes']",['methotrexate'],"[' number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility', 'uneventful clinical resolution of a persistent PUL without change from the initial management strategy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3495853', 'cui_str': 'Pregnancy of unknown location'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392534', 'cui_str': 'Ruptured ectopic pregnancy (disorder)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4034144', 'cui_str': 'Methotrexate Injection'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.229722,This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.,"[{'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stephenson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City, OK, United States.'}, {'ForeName': 'Wahid A', 'Initials': 'WA', 'LastName': 'Youssef', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, United States.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Reproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.009']
745,32149378,Effectiveness of Sexual Skills Training Program on Promoting Sexual Intimacy and Satisfaction in Women in Tehran (Iran): A randomized clinical Trial Study.,"PURPOSE


The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women.
MATERIALS AND METHODS


This is a randomized clinical trial study with parallel design. 70 participants (n=35 each) were divided into 2 groups as control and intervention groups. Women were selected in multiple steps. Some requirements for inclusion criteria were: obtaining a standard score of marital satisfaction, women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian. Some factors for exclusion criteria were: women's absence in more than 2 training classes, pregnancy during the study. Data collection was conducted through four questionnaires: demographic characteristics, marital satisfaction, sexual satisfaction and sexual intimacy. Validity and reliability of the questionnaires were measured through content validity and Chronbach Alpha, respectively. The data extracted from the questionnaires were analyzed using SPSS software, version 18.0. For data analysis, descriptive statistics, independent t-test, paired t-test, or non-parametric tests were applied. Significance level of the test was considered p<0.05.
RESULTS


The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
CONCLUSION


In total, the training lessons gave positive views to participants towards their sexual issues so that they formed realistic and positive sexual expectations, healthier sexual behaviors and self-expressions and consequently, gained more sexual knowledge that made them able to experience more intimacy and satisfaction in sexual relationships with their spouses.",2020,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","['women', 'Women in Tehran (Iran', 'women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian', '70 participants (n=35 each']","['Sexual Skills Training Program', 'sexual skills training']","['intimacy and sexual satisfaction', 'sexual satisfaction (p<0.001) and sexual intimacy', 'Sexual Intimacy and Satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",70.0,0.054477,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Salehi Moghaddam', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fatemehsalehi28@yahoo.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'TurkZahrani', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Moslemi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Arak University of Medical Sciences ,Arak, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'MD, MPH, FECSM, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Joulaee Rad', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4690']
746,32039559,"Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial.","In a phase 2 multicenter open-label randomized trial sponsored by the National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients were randomized to a calcineurin inhibitor (CNI)-based immunosuppressive regimen (tacrolimus) (n = 21), or an investigational arm using low-dose CNI plus costimulation blockade (belatacept) with intended CNI withdrawal (n = 22). Both arms included induction therapy with rabbit ATG, mycophenolate sodium, or mycophenolate mofetil and rapid withdrawal of steroids. Enrollment and CNI withdrawal were stopped after 43/60 planned subjects had been enrolled. At that time, the rate of biopsy-proven acute rejection (BPAR) of the pancreas was low in both groups until CNI was withdrawn, with four of the five pancreas rejections occurring during or after CNI withdrawal. The rate of BPAR of kidney allografts was low in both control (9.5%) and investigational (9.1%) arms. Pancreas graft survival at 52 weeks, defined by insulin independence, was 21 (100%) in the control group and 19 (86%) in the investigational arm. One subject in the investigational arm died with functioning pancreas and kidney grafts. Renal function at week 52 was similar in both arms. Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.",2020,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"['43/60 planned subjects had been enrolled', 'SPK transplants undergoing CNI withdrawal', 'combined pancreas and kidney transplantation', 'National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients']","['rabbit ATG, mycophenolate sodium or mycophenolate mofetil', 'calcineurin inhibitor (CNI) based immunosuppressive regimen (tacrolimus) (n=21) or an investigational arm using low-dose CNI plus co-stimulation blockade (belatacept) with intended CNI withdrawal', 'belatacept', 'calcineurin inhibitor withdrawal']","['Pancreas graft survival', 'Renal function', 'rate of biopsy proven acute rejection (BPAR) of the pancreas', 'rate of BPAR of kidney allografts']","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}]","[{'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]",,0.0714917,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'UCSF, San Francisco, California, USA.'}, {'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'UAB, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ikle', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Odorico', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fridell', 'Affiliation': 'IU, Indianapolis, Indiana, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15817']
747,31850492,The Effect of a Priest-Led Intervention on the Choice and Preference of Soda Beverages: A Cluster-Randomized Controlled Trial in Catholic Parishes.,"BACKGROUND


Latin America ranks among the regions with the highest level of intake of sugary beverages in the world. Innovative strategies to reduce the consumption of sugary drinks are necessary.
PURPOSE


Evaluate the effect of a one-off priest-led intervention on the choice and preference of soda beverages.
METHODS


We conducted a pragmatic cluster-randomized trial in Catholic parishes, paired by number of attendees, in Chimbote, Peru between March and June of 2017. The priest-led intervention, a short message about the importance of protecting one's health, was delivered during the mass. The primary outcome was the proportion of individuals that choose a bottle of soda instead of a bottle of water immediately after the service. Cluster-level estimates were used to compare primary and secondary outcomes between intervention and control groups utilizing nonparametric tests.
RESULTS


Six parishes were allocated to control and six to the intervention group. The proportion of soda selection at baseline was ~60% in the intervention and control groups, and ranged from 56.3% to 63.8% in Week 1, and from 62.7% to 68.2% in Week 3. The proportion of mass attendees choosing water over soda was better in the priest-led intervention group: 8.2% higher at Week 1 (95% confidence interval 1.7%-14.6%, p = .03), and 6.2% higher at 3 weeks after baseline (p = .15).
CONCLUSIONS


This study supports the proof-of-concept that a brief priest-led intervention can decrease sugary drink choice.
CLINICAL TRIAL INFORMATION


ISRCTN, ISRCTN24676734. Registered 25 April 2017, https://www.isrctn.com/ISRCTN24676734.",2020,"The proportion of mass attendees choosing water over soda was better in the priest-led intervention group: 8.2% higher at Week 1 (95% confidence interval 1.7%-14.6%, p = .03), and 6.2% higher at 3 weeks after baseline (p = .15).
","['Catholic parishes, paired by number of attendees, in Chimbote, Peru between March and June of 2017', 'Soda Beverages']","['one-off priest-led intervention', 'Priest-Led Intervention']","['proportion of soda selection', 'sugary drink choice', 'proportion of individuals that choose a bottle of soda instead of a bottle of water immediately after the service', 'proportion of mass attendees choosing water over soda']","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0558272', 'cui_str': 'Priests'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.114264,"The proportion of mass attendees choosing water over soda was better in the priest-led intervention group: 8.2% higher at Week 1 (95% confidence interval 1.7%-14.6%, p = .03), and 6.2% higher at 3 weeks after baseline (p = .15).
","[{'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Miraflores, Lima, Peru.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Taype-Rondan', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Miraflores, Lima, Peru.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Bazalar-Palacios', 'Affiliation': 'Centro de Estudios de Población, Universidad Católica los Ángeles de Chimbote, Casco Urbano, Chimbote, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Miraflores, Lima, Peru.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Center for Advanced Hindsight, Duke University, Durham, NC, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz060']
748,31738927,Acute Ventilatory Support During Whole-Body Hybrid Rowing in Patients With High-Level Spinal Cord Injury: A Randomized Controlled Crossover Trial.,"BACKGROUND


High-level spinal cord injury (SCI) results in profound spinal and supraspinal deficits, leading to substantial ventilatory limitations during whole-body hybrid functional electrical stimulation (FES)-rowing, a form of exercise that markedly increases the active muscle mass via electrically induced leg contractions. This study tested the effect of noninvasive ventilation (NIV) on ventilatory and aerobic capacities in SCI.
METHODS


This blinded, randomized crossover study enrolled 19 patients with SCI (level of injury ranging from C4 to T8). All patients were familiar with FES-rowing and had plateaued in their training-related increases in aerobic capacity. Patients performed two FES-rowing peak exercise tests with NIV or without NIV (sham).
RESULTS


NIV increased exercise tidal volume (peak, 1.50 ± 0.31 L vs 1.36 ± 0.34 L; P < .05) and reduced breathing frequency (peak, 35 ± 7 beats/min vs 38 ± 6 beats/min; P < .05) compared with the sham test, leading to no change in alveolar ventilation but a trend toward increased oxygen uptake efficiency (P = .06). In those who reached peak oxygen consumption (Vo 2 peak) criteria (n = 13), NIV failed to significantly increase Vo 2 peak (1.73 ± 0.66 L/min vs 1.78 ± 0.59 L/min); however, the range of responses revealed a correlation between changes in peak alveolar ventilation and Vo 2 peak (r = 0.89; P < .05). Furthermore, those with higher level injuries and shorter time since injury exhibited the greatest increases in Vo 2 peak.
CONCLUSIONS


Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve Vo 2 peak in all patients. Those who benefit most seem to be patients with cervical SCI within a shorter time since injury.
TRIAL REGISTRY


ClinicalTrials.gov; Nos.: NCT02865343 and NCT03267212; URL: www.clinicaltrials.gov.",2020,Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve VO 2 peak in all patients.,"['patients with high-level spinal cord injury', 'Nineteen patients with SCI (C4-T8']","['Acute ventilatory support during whole-body hybrid rowing', 'non-invasive ventilation (NIV', 'FES-rowing peak exercise tests with NIV or Sham']","['oxygen uptake efficiency', 'exercise tidal volume', 'VO2peak', 'reduced breathing frequency', 'ventilatory efficiency', 'alveolar ventilation (VA', 'aerobic capacity', 'ventilatory and aerobic capacities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V), function (observable entity)'}]",,0.189248,Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve VO 2 peak in all patients.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston MA; Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA. Electronic address: ivivodtzev@partners.org.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA.'}, {'ForeName': 'Felipe X', 'Initials': 'FX', 'LastName': 'Cepeda', 'Affiliation': 'Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston MA; Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA.'}]",Chest,['10.1016/j.chest.2019.10.044']
749,31767595,"Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.","INTRODUCTION


Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.
METHODS AND ANALYSIS


In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.
TRIAL REGISTRATION NUMBER


NCT03226743.",2019,"While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models.","['n=570 patients will be recruited from primary care practices (n=19 practices per group', 'patients with mental disorders in primary care']",['collaborative and stepped care model'],['mental health-related quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",570.0,0.144746,"While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany d.heddaeus@uke.de.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brettschneider', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'von dem Knesebeck', 'Affiliation': 'Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Maehder', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Porzelt', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schulte', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Weigel', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Werner', 'Affiliation': 'Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032408']
750,31319102,Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study.,"BACKGROUND


Peanut allergy causes severe and fatal reactions. Current food allergen labeling does not address these risks adequately against the burden of restricting food choice for allergic patients because of limited data on thresholds of reactivity and the influence of everyday factors.
OBJECTIVE


We estimated peanut threshold doses for a United Kingdom population with peanut allergy and examined the effect of sleep deprivation and exercise.
METHODS


In a crossover study, after blind challenge, participants with peanut allergy underwent 3 open peanut challenges in random order: with exercise after each dose, with sleep deprivation preceding challenge, and with no intervention. Primary outcome was the threshold dose triggering symptoms (in milligrams of protein). Primary analysis estimated the difference between the nonintervention challenge and each intervention in log threshold (as percentage change). Dose distributions were modeled, deriving eliciting doses in the population with peanut allergy.
RESULTS


Baseline challenges were performed in 126 participants, 100 were randomized, and 81 (mean age, 25 years) completed at least 1 further challenge. The mean threshold was 214 mg (SD, 330 mg) for nonintervention challenges, and this was reduced by 45% (95% CI, 21% to 61%; P = .001) and 45% (95% CI, 22% to 62%; P = .001) for exercise and sleep deprivation, respectively. Mean estimated eliciting doses for 1% of the population were 1.5 mg (95% CI, 0.8-2.5 mg) during nonintervention challenge (n = 81), 0.5 mg (95% CI, 0.2-0.8 mg) after sleep, and 0.3 mg (95% CI, 0.1-0.6 mg) after exercise.
CONCLUSION


Exercise and sleep deprivation each significantly reduce the threshold of reactivity in patients with peanut allergy, putting them at greater risk of a reaction. Adjusting reference doses using these data will improve allergen risk management and labeling to optimize protection of consumers with peanut allergy.",2019,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"['peanut-allergic adults', '126 subjects, 100 were randomized and 81 (mean age 25y) completed at least one further challenge', 'peanut-allergic participants']","['sleep deprivation and exercise', 'Exercise and sleep deprivation']",['threshold dose triggering symptoms (mg protein'],"[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",100.0,0.275034,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Dua', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom. Electronic address: shelley.dua@addenbrookes.nhs.uk.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': ""Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Allergy and Clinical Immunology, Section Inflammation Repair and Development National heart and Lung Institute, Faculty of Medicine, Imperial College, London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kimber', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'NIHR Southampton Respiratory Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; University of Southampton Faculty of Medicine, Southampton, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Skypala', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, United Kingdom; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ewan', 'Affiliation': ""Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; Centre of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.038']
751,30563932,"PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial.","PURPOSE


Endometrioid endometrial cancer is strongly associated with obesity and insulin resistance. Metformin, an insulin sensitizer, reduces endometrial tumor growth  in vitro . Presurgical window studies allow rapid  in vivo  assessment of antitumor activity. Previous window studies found metformin reduced endometrial cancer proliferation but these lacked methodological rigor. PREMIUM measured the anti-proliferative effect of metformin  in vivo  using a robust window study design. Patients and Methods:  A multicenter, double-blind, placebo-controlled trial randomized women with atypical hyperplasia or endometrioid endometrial cancer to receive metformin (850 mg daily for 3 days, and twice daily thereafter) or placebo for 1 to 5 weeks until surgery. The primary outcome was posttreatment IHC expression of Ki-67. Secondary outcomes investigated the effect of metformin on markers of the PI3K-Akt-mTOR and insulin signaling pathways and obesity.
RESULTS


Eighty-eight women received metformin ( n  = 45) or placebo ( n  = 43) and completed treatment. There was no overall difference in posttreatment Ki-67 between the metformin and placebo arms, in an ANCOVA analysis adjusting for baseline Ki-67 expression (mean difference -0.57%; 95% CI, -7.57%-6.42%;  P  = 0.87). Metformin did not affect expression of markers of the PI3K-Akt-mTOR or insulin signaling pathways, and did not result in weight loss.
CONCLUSIONS


Short-term treatment with standard diabetic doses of metformin does not reduce tumor proliferation in women with endometrioid endometrial cancer awaiting hysterectomy. This study does not support a biological effect of metformin in endometrial cancer and casts doubt on its potential application in the primary and adjuvant treatment settings.",2019,"There was no overall difference in posttreatment Ki-67 between the metformin and placebo arms, in an ANCOVA analysis adjusting for baseline Ki-67 expression (mean difference -0.57%; 95% CI, -7.57%-6.42%;  P  = 0.87).","['women with atypical hyperplasia or endometrioid endometrial cancer to receive', 'In Uterine Malignancy (PREMIUM', 'women with endometrioid endometrial cancer awaiting hysterectomy', 'Eighty-eight women received']","['placebo', 'metformin', 'Placebo', 'PRE-surgical Metformin', 'Metformin']","['weight loss', 'baseline Ki-67 expression', 'endometrial cancer proliferation', 'tumor proliferation', 'posttreatment Ki-67', 'markers of the PI3K-Akt-mTOR and insulin signaling pathways and obesity', 'posttreatment IHC expression of Ki-67']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0333977', 'cui_str': 'Atypical hyperplasia (morphologic abnormality)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.63688,"There was no overall difference in posttreatment Ki-67 between the metformin and placebo arms, in an ANCOVA analysis adjusting for baseline Ki-67 expression (mean difference -0.57%; 95% CI, -7.57%-6.42%;  P  = 0.87).","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Kitson', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Maskell', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Vanitha N', 'Initials': 'VN', 'LastName': 'Sivalingam', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Allen', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': ""Department of Obstetrics and Gynaecology, St Mary's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Burns', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, United Kingdom.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Gilmour', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tameside and Glossop Integrated Care NHS Foundation Trust, Ashton-under-Lyne, United Kingdom.'}, {'ForeName': 'Rahamatulla', 'Initials': 'R', 'LastName': 'Latheef', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Slade', 'Affiliation': 'Department of Gynaecological Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Pemberton', 'Affiliation': 'Department of Clinical Biochemistry, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Department of Histopathology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'W David', 'Initials': 'WD', 'LastName': 'Ryder', 'Affiliation': 'Manchester Academic Health Science Centre-Clinical Trials Coordination Unit, Manchester, United Kingdom.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Crosbie', 'Affiliation': ""Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, United Kingdom. emma.crosbie@manchester.ac.uk.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3339']
752,31077258,Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis.,"BACKGROUND


The efficacy and safety of apremilast were assessed in patients with psoriatic arthritis (PsA) in three phase III clinical trials with similar designs (PALACE 1, 2, and 3).
METHODS


Following a 24-week, randomized (1:1:1 to apremilast 30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase and a 28-week blinded active treatment phase, patients could receive apremilast in open-label extension studies for an additional 4 years. Eligible adult patients had active PsA for ≥ 6 months and three or more swollen joints and three or more tender joints despite prior treatment with disease-modifying anti-rheumatic drugs.
RESULTS


A total of 1493 randomized patients received one or more doses of study medication (placebo: n = 496; apremilast 30 mg twice daily: n = 497; apremilast 20 mg twice daily: n = 500). In patients continuing apremilast treatment, response was sustained without new safety issues. At week 260, 67.2% of remaining patients achieved an ACR20 response, and 44.4% and 27.4% achieved ACR50 and ACR70 responses, respectively. Among patients with baseline enthesitis and dactylitis, 62.4% achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 80.9% achieved a dactylitis count of 0, respectively. In patients who had ≥ 3% baseline psoriasis body surface area involvement, 43.6% achieved ≥ 75% reduction from the baseline Psoriasis Area and Severity Index scores. The most commonly reported adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs occurring within the first 2 weeks of treatment and usually resolving within 4 weeks. Reported rates of depression during the study were low (≤ 1.8%). The majority of patients maintained their weight within 5% of baseline during the study. No new safety concerns or increases in the incidence or severity of AEs were observed over the long term.
CONCLUSIONS


Apremilast maintained clinical benefit and a favorable safety profile for up to 5 years among patients with PsA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01172938 , NCT01212757 , NCT01212770.",2019,"The most commonly reported adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs occurring within the first 2 weeks of treatment and usually resolving within 4 weeks.","['Eligible adult patients had active PsA for ≥\u20096\u2009months and three or more swollen joints and three or more tender joints despite prior treatment with disease-modifying anti-rheumatic drugs', 'patients with psoriatic arthritis (PsA) in three phase III clinical trials with similar designs (PALACE 1, 2, and 3', 'patients with psoriatic arthritis']","['apremilast 30\u2009mg twice daily', 'placebo', 'study medication (placebo: n\u2009=\u2009496; apremilast 30\u2009mg twice daily: n\u2009=\u2009497; apremilast 20\u2009mg twice daily: n\u2009=\u2009500']","['Maastricht Ankylosing Spondylitis Enthesitis Score', 'rates of depression', 'incidence or severity of AEs', 'baseline Psoriasis Area and Severity Index scores', 'ACR50 and ACR70 responses', 'ACR20 response', 'adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0003191', 'cui_str': 'Anti-Rheumatic Drugs'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}]","[{'cui': 'C3819585', 'cui_str': 'apremilast 30 MG [Otezla]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3820194', 'cui_str': 'apremilast 20 MG'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",1493.0,0.328637,"The most commonly reported adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs occurring within the first 2 weeks of treatment and usually resolving within 4 weeks.","[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'School of Medicine, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92037, USA. akavanaugh@ucsd.edu.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Division of Rheumatology, Krembil Research Institute, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guerette', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Delev', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Teng', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Rheumatology Clinical Research Division, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-1901-3']
753,30668636,Comparison of Treadmill Trip-Like Training Versus Tai Chi to Improve Reactive Balance Among Independent Older Adult Residents of Senior Housing: A Pilot Controlled Trial.,"BACKGROUND


There is growing interest in using perturbation-based balance training to improve the reactive response to common perturbations (eg, tripping and slipping). The goal of this study was to compare the efficacy of treadmill-based reactive balance training versus Tai Chi performed at, and among independent residents of, older adult senior housing.
METHODS


Thirty-five residents from five senior housing facilities were allocated to either treadmill-based reactive balance training or Tai Chi training. Both interventions were performed three times per week for 4 weeks, with each session lasting approximately 30 minutes. A battery of balance tests was performed at baseline, and again 1 week, 1 month, 3 months, and 6 months post-training. The battery included six standard clinical tests of balance and mobility, and a test of reactive balance performance.
RESULTS


At baseline, no significant between-group differences were found for any balance tests. After training, reactive balance training participants had better reactive balance than Tai Chi participants. Maximum trunk angle was 13.5° smaller among reactive balance training participants 1 week after training (p = .01), and a reactive balance rating was 24%-31% higher among reactive balance training participants 1 week to 6 months after training (p < .03). Clinical tests showed minimal differences between groups at any time point after training.
CONCLUSION


Trip-like reactive balance training performed at senior housing facilities resulted in better rapid balance responses compared with Tai Chi training.",2019,"Maximum trunk angle was 13.5 degrees smaller among reactive balance training participants one week after training (p = .01), and a reactive balance rating was 24-31% higher among reactive balance training participants one week to six months after training (p < .03).","['residents of, older adult senior housing', 'Methods\n\n\nThirty-five residents from five senior housing facilities', 'older adult residents of senior housing']","['treadmill-based reactive balance training or Tai Chi training', 'reactive balance training', 'treadmill trip-like training versus Tai Chi', 'treadmill-based reactive balance training versus Tai Chi']","['Maximum trunk angle', 'reactive balance rating', 'reactive balance', 'rapid balance responses']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0221188', 'cui_str': 'Tripping (event)'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",1.0,0.0243847,"Maximum trunk angle was 13.5 degrees smaller among reactive balance training participants one week after training (p = .01), and a reactive balance rating was 24-31% higher among reactive balance training participants one week to six months after training (p < .03).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aviles', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Leigh J', 'Initials': 'LJ', 'LastName': 'Allin', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Neil B', 'Initials': 'NB', 'LastName': 'Alexander', 'Affiliation': 'Division of Geriatric and Palliative Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Van Mullekom', 'Affiliation': 'Department of Statistics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Maury A', 'Initials': 'MA', 'LastName': 'Nussbaum', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Madigan', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz018']
754,31138068,Testosterone reduces the threat premium in competitive resource division.,"Like other animals, humans are sensitive to facial cues of threat. Recent evidence suggests that we use this information to dynamically calibrate competitive decision-making over resources, ceding more to high-threat individuals (who appear more willing/able to retaliate) and keeping more from low-threat individuals. Little is known, however, about the biological factors that support such threat assessment and decision-making systems. In a pre-registered, double-blind, placebo-controlled, cross-over testosterone administration study ( n = 118 men), we show for the first time that testosterone reduces the effects of threat on decision-making: participants ceded more resources to high-threat (versus low-threat) individuals (replicating the 'threat premium'), but this effect was blunted by testosterone, which selectively reduced the amount of resources ceded to those highest in threat. Thus, our findings suggest that testosterone influences competitive decision-making by recalibrating the integration of threat into the decision-making process.",2019,"Recent evidence suggests that we use this information to dynamically calibrate competitive decision-making over resources, ceding more to high-threat individuals (who appear more willing/able to retaliate) and keeping more from low-threat individuals.",[' n = 118 men'],"['testosterone', 'Testosterone', 'placebo-controlled, cross-over testosterone administration study']",[],"[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],118.0,0.109311,"Recent evidence suggests that we use this information to dynamically calibrate competitive decision-making over resources, ceding more to high-threat individuals (who appear more willing/able to retaliate) and keeping more from low-threat individuals.","[{'ForeName': 'Shawn N', 'Initials': 'SN', 'LastName': 'Geniole', 'Affiliation': '1 Department of Psychology, Nipissing University , 100 College Drive, North Bay, Ontario, Canada P1B8L7.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Proietti', 'Affiliation': '1 Department of Psychology, Nipissing University , 100 College Drive, North Bay, Ontario, Canada P1B8L7.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Bird', 'Affiliation': '3 Department of Psychology, Simon Fraser University , 8888 University Drive, Burnaby, British Columbia, Canada V5A 1S6.'}, {'ForeName': 'Triana L', 'Initials': 'TL', 'LastName': 'Ortiz', 'Affiliation': '1 Department of Psychology, Nipissing University , 100 College Drive, North Bay, Ontario, Canada P1B8L7.'}, {'ForeName': 'Pierre L', 'Initials': 'PL', 'LastName': 'Bonin', 'Affiliation': '4 Northern Ontario School of Medicine , 935 Ramsey Lake Rd, Sudbury, Canada P3E 2C6.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Goldfarb', 'Affiliation': '4 Northern Ontario School of Medicine , 935 Ramsey Lake Rd, Sudbury, Canada P3E 2C6.'}, {'ForeName': 'Neil V', 'Initials': 'NV', 'LastName': 'Watson', 'Affiliation': '3 Department of Psychology, Simon Fraser University , 8888 University Drive, Burnaby, British Columbia, Canada V5A 1S6.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Carré', 'Affiliation': '1 Department of Psychology, Nipissing University , 100 College Drive, North Bay, Ontario, Canada P1B8L7.'}]",Proceedings. Biological sciences,['10.1098/rspb.2019.0720']
755,31138316,"Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study.","BACKGROUND


Sandoz etanercept (SDZ ETN; GP2015) is an etanercept biosimilar with equivalent efficacy and comparable safety and immunogenicity to reference etanercept (ETN) in patients with moderate-to-severe chronic plaque-type psoriasis.
METHODS


EQUIRA was a phase III, double-blind study conducted in patients with moderate-to-severe rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs. Eligible patients were randomized 1:1 to receive subcutaneous 50 mg SDZ ETN or ETN, once-weekly, for 24 weeks. At week 24, patients with at least moderate EULAR response in the SDZ ETN group continued SDZ ETN treatment, and those in the ETN group were switched to receive 50 mg SDZ ETN, for up to 48 weeks. Patients received concomitant methotrexate at a stable dose (10-25 mg/week) and folic acid (≥ 5 mg/week). Equivalence between SDZ ETN and ETN for change from baseline in disease activity score including 28 joint count C-reactive protein (DAS28-CRP) at week 24 (primary endpoint) and comparable safety and immunogenicity profile of SDZ ETN and ETN have previously been demonstrated at week 24. Herein, we present the 48-week results of the study after a single switch from ETN to its biosimilar at week 24.
RESULTS


The least squares mean (standard error) change in DAS28-CRP from baseline up to week 48 was comparable between ""continued SDZ ETN"" (- 2.90 [0.12], n = 148) and ""switched to SDZ ETN"" (- 2.78 [0.13], n = 131) groups. The proportion of patients achieving EULAR good/moderate responses based on DAS28-erythrocyte sedimentation rate and ACR20/50/70 response rates were comparable between the two groups. The proportion of patients with at least one treatment-emergent adverse event was 42.9% in the ""continued SDZ ETN"" and 38.0% in the ""switched to SDZ ETN"" groups. Serious adverse events occurred in 4 patients in each of the two groups. After week 24, none of the patients in the switched group developed anti-drug antibodies (ADAs), while 4 patients in the continued SDZ ETN group had single-event, very low titer, non-neutralizing ADAs detected.
CONCLUSIONS


The 48-week results from the EQUIRA study demonstrate that switch from ETN to SDZ ETN in patients with moderate-to-severe rheumatoid arthritis does not impact the efficacy, safety, or immunogenicity of etanercept.
TRIAL REGISTRATION


EudraCT number 2012-002009-23 , Registered 19 April 2012-prospectively registered.",2019,"After week 24, none of the patients in the switched group developed anti-drug antibodies (ADAs), while 4 patients in the continued SDZ ETN group had single-event, very low titer, non-neutralizing ADAs detected.
","['patients with moderate-to-severe rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs', 'EudraCT number 2012-002009-23 , Registered 19 April 2012-prospectively registered', 'patients with moderate-to-severe rheumatoid arthritis', 'Eligible patients', 'patients with moderate-to-severe chronic plaque-type psoriasis']","['etanercept', 'concomitant methotrexate', 'folic acid', 'etanercept (ETN', 'subcutaneous 50\u2009mg SDZ ETN or ETN']","['anti-drug antibodies (ADAs', 'disease activity score including 28 joint count C-reactive protein (DAS28-CRP', 'Serious adverse events', 'DAS28-erythrocyte sedimentation rate and ACR20/50/70 response rates', 'least squares mean (standard error) change in DAS28-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003191', 'cui_str': 'Anti-Rheumatic Drugs'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0386444,"After week 24, none of the patients in the switched group developed anti-drug antibodies (ADAs), while 4 patients in the continued SDZ ETN group had single-event, very low titer, non-neutralizing ADAs detected.
","[{'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Jaworski', 'Affiliation': 'Reumatika-Centrum Reumatologii, 02-691, Warsaw, Poland. januszjaworski@ymail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'Department of Experimental and Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Florence, Italy.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Maya H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Eugeniusz J', 'Initials': 'EJ', 'LastName': 'Kucharz', 'Affiliation': 'Department of Internal Medicine, Rheumatology and Clinical Immunology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Cochin Hospital, Rheumatology A department, Paris Descartes University, Paris, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'UC San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Hexal AG, a Sandoz company, Holzkirchen, Germany.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Babic', 'Affiliation': 'Hexal AG, a Sandoz company, Holzkirchen, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-019-1907-x']
756,30262813,Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial.,"BACKGROUND


The effects of probiotic Bifidobacterium animalis subsp. lactis CECT 8145 (Ba8145) and those of its heat-killed form (h-k Ba8145) on human anthropometric adiposity biomarkers are unknown.
OBJECTIVE


To assess the effect of Ba8145 and h-k Ba8145 ingestion on anthropometric adiposity biomarkers.
DESIGN


Randomized, parallel, double-blind, placebo-controlled trial with abdominally obese individuals. Participants (n = 135) consumed 1 capsule/day containing 10 10  colony forming unit (CFU) of Ba8145, 10 10  CFU of h-k Ba8145, or placebo (maltodextrin) for 3 months.
RESULTS


Ba8145 ingestion decreased waist circumference, waist circumference/height ratio, and Conicity index (P < 0.05) versus its baseline. Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment. Ba8145 decreased the body mass index compared with baseline and placebo group (P < 0.05). The decrease in visceral fat area after Ba8145 treatments reached significance (P < 0.05) only after h-k Ba8145. When analyses by gender were performed, significance remained only for women. Diastolic blood pressure and HOMA index decreased (P < 0.05) after h-k Ba8145. Gut microbiome analyses showed an increase in Akkermansia spp. after Ba8145 treatment, particularly in the live form, which was inversely related to weight (P = 0.003).
CONCLUSIONS


In abdominally obese individuals, consumption of Ba8145, both as viable and mainly as heat-killed cells, improves anthropometric adiposity biomarkers, particularly in women. An increase in the gut Akkermansia genus appears as a possible mechanism involved. Our results support Ba8145 probiotic as a complementary strategy in obesity management.",2019,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"['abdominally obese subjects', 'abdominally obese individuals']","['probiotic Bifidobacterium animalis subsp', 'lactis CECT', 'placebo (maltodextrin', 'placebo', 'Ba8145 and h-k Ba8145 ingestion']","['Diastolic blood pressure and HOMA index', 'visceral fat area', 'anthropometric adiposity biomarkers', 'waist circumference, waist circumference/height ratio, and Conicity index', 'body mass index', 'Akkermansia spp']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1490589', 'cui_str': 'Genus Akkermansia (organism)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}]",,0.269698,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain. rosamaria.valls@urv.cat.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ortega', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Caimari', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Genovés', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martorell', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Codoñer', 'Affiliation': 'Lifesequencing/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}]",International journal of obesity (2005),['10.1038/s41366-018-0220-0']
757,31898531,0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial.,"BACKGROUND


Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA.
METHODS


This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA. The study was done in a tertiary care, teaching, and referral hospital in India in children (> 1 month-12 years) with DKA as defined by ISPAD. Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded. Sixty-six children were randomized to receive either Plasma-Lyte (n = 34) or 0.9% saline (n = 32).
MAIN OUTCOMES


Primary outcome was incidence of new or progressive AKI, defined as a composite outcome of change in creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels. The secondary outcomes were resolution of AKI, time to resolution of DKA (pH > 7.3, bicarbonate> 15 mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay.
RESULTS


Baseline characteristics were similar in both groups. The incidence of new or progressive AKI was similar in both [Plasma-Lyte 13 (38.2%) versus 0.9% saline 15 (46.9%); adjusted OR 1.22; 95% CI 0.43-3.43, p = 0.70]. The median (IQR) time to resolution of DKA in Plasma-Lyte-A and 0.9% saline were 14.5 (12 to 20) and 16 (8 to 20) h respectively. Time to resolution of AKI was similar in both [Plasma-Lyte 22.1 versus 0.9% saline 18.8 h (adjusted HR 1.72; 95% CI 0.83-3.57; p = 0.14)]. Length of hospital stay was also similar in both [Plasma-Lyte 9 (8 to 12) versus 0.9% saline 10 (8.25 to 11) days; p = 0.39].
CONCLUSIONS


The incidence of new or progressive AKI and resolution of AKI were similar in both groups. Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay.
TRIAL REGISTRATION


Clinical trial registry of India, CTRI/2018/05/014042 (ctri.nic.in) (Retrospectively registered).",2020,"Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay.
","['tertiary care, teaching, and referral hospital in India in children (>\u20091\u2009month-12\u2009years) with DKA as defined by ISPAD', 'Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded', 'adults with septic shock', 'Sixty-six children', 'children with diabetic ketoacidosis (SPinK trial']","['saline versus Plasma-Lyte', 'saline with Plasma-Lyte-A', 'Plasma-Lyte (n\xa0=\u200934) or 0.9% saline']","['incidence of new or progressive AKI and resolution of AKI', 'RRT, mortality, and lengths of PICU and hospital stay', 'incidence of new or progressive AKI', 'median (IQR) time to resolution of DKA', 'Time to resolution of AKI', 'incidence of new or progressive AKI, defined as a composite outcome of change in\xa0creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels', 'Length of hospital stay', 'resolution of AKI, time to resolution of DKA (pH\u2009>\u20097.3, bicarbonate>\u200915\u2009mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0006114', 'cui_str': 'Cerebral Edema'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0035611', 'cui_str': 'Rifles'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C0428196', 'cui_str': 'Bicarbonate level - finding'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",66.0,0.73124,"Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay.
","[{'ForeName': 'Vijai', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Jayashree', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India. mjshree@hotmail.com.'}, {'ForeName': 'Karthi', 'Initials': 'K', 'LastName': 'Nallasamy', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Dayal', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Rawat', 'Affiliation': 'Division of Pediatric Allergy & Immunology, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}]","Critical care (London, England)",['10.1186/s13054-019-2683-3']
758,31754962,"Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study.","BACKGROUND


LATITUDE was the first phase 3 trial examining the survival benefit of adding abiraterone acetate (AA) + prednisone (P) to androgen-deprivation therapy (ADT) in newly diagnosed metastatic, castration-sensitive prostate cancer (mCSPC). Due to significant improvement in overall survival after the first interim analysis, patients in the placebos + ADT arm could switch to AA + P + ADT during an open-label extension. As in other studies where switching is allowed, statistical adjustments are needed to assess the real benefit of new drugs.
PATIENTS AND METHODS


This was a post hoc analysis to estimate the true survival benefit of AA + P + ADT in patients with newly diagnosed mCSPC by applying statistical adjustments commonly used to adjust for treatment switching.
RESULTS


Of 112 patients still receiving placebos + ADT at the first interim analysis, 72 switched to AA + P + ADT during the open-label extension. Final analysis was conducted after median follow-up of 51.8 months. Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights.
CONCLUSIONS


Analyses adjusting for treatment switching using two different statistical approaches confirm the improved survival benefit of adding AA + P to ADT in patients with newly diagnosed mCSPC.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT01715285.",2019,"Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights.
","['112 patients still receiving', 'patients with newly diagnosed mCSPC', 'newly diagnosed metastatic, castration-sensitive prostate cancer (mCSPC']","['AA\u2009+\u2009P\u2009+\u2009ADT', 'placebos\u2009+\u2009ADT', 'abiraterone acetate (AA)\u2009+\u2009prednisone (P) to androgen-deprivation therapy (ADT']","['risk of death', 'survival benefit', 'overall survival']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",112.0,0.296385,"Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights.
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Urologic Oncology, Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Urologic Oncology, Centre Hospitalier de L'Université de Montréal/CRCHUM, Montréal, QC, Canada.""}, {'ForeName': 'Nolen Joy', 'Initials': 'NJ', 'LastName': 'Perualila', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium. NPeruali@its.jnj.com.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Van Sanden', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Diels', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, High Wycombe, Buckinghamshire, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Clinical Oncology, Janssen Research & Development BE, Spring House, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, University of Paris Sud, Paris, France.'}]",Targeted oncology,['10.1007/s11523-019-00685-x']
759,31399142,"Effects of two types of exercise training on psychological well-being, sleep, quality of life and physical fitness in patients with high-grade glioma (WHO III and IV): study protocol for a randomized controlled trial.","BACKGROUND


There is existing evidence on whether and to what degree regular exercise training improves the quality of life (QoL) among cancer survivors. However, in regards to patients with high-grade glioma (HGG; WHO grade III and IV), no conclusive study has been performed so far. The present trial aims to fill this gap by examining whether psychological well-being, sleep, QoL and physical fitness might be improved with two different types of exercise, as compared to an active control condition. Active control condition represent individuals participating at regular meetings to talk about their current life situation, though, the meetings were not intended as that of the psychotherapy group. Regular meetings are of the same frequency, duration, and intensity as the exercise interventions.
METHODS


A total of 45 patients with HGG after undergoing neurosurgery and adjuvant radiotherapy, chemotherapy, or chemoradiotherapy will be consecutively and randomly assigned to (a) an endurance training, (b) a resistance training or (c) to an active control condition. The intervention will last for 6 consecutive weeks, consisting of 2 weekly sessions (30-45 min per session). Measurements would take place at three time points, namely at the beginning of the study (baseline), 3 weeks after the beginning of the study, and 6 weeks after the beginning of the study. The last measurement also represents the end of the study. Aerobic exercise performance will be assessed objectively with a 6-min walking test, and a handgrip test will be used to assess the upper body strength. Further, participants will complete a battery of questionnaires covering sociodemographic information, QoL, sleep quality and sleep patterns, coping with stress, state- and trait-anxiety, depression, and fatigue. In parallel, experts will use the Hamilton Depression Rating Scale to determine and rate participants' symptoms of depression.
SIGNIFICANCE


The present study will be the first to investigate and compare the impact of two different exercise modalities, namely endurance and resistance training, on physical fitness and dimensions of well-being, and sleep among patients with HGG who underwent neurosurgery followed by adjuvant radiotherapy, chemotherapy, or chemoradiotherapy. Importantly, unlike the majority of previous studies, the control condition consists of an active set-up to detect possible factual beneficial effects of exercise training, irrespective of social interactions. Trial registration https://register.clinicaltrials.gov ; identifier: NCT03775369.",2019,"Importantly, unlike the majority of previous studies, the control condition consists of an active set-up to detect possible factual beneficial effects of exercise training, irrespective of social interactions.","['patients with HGG who underwent neurosurgery followed by', 'patients with high-grade glioma (HGG; WHO grade III and IV', '45 patients with HGG after undergoing neurosurgery and', 'patients with high-grade glioma (WHO III and IV', 'cancer survivors']","['adjuvant radiotherapy, chemotherapy, or chemoradiotherapy', 'exercise modalities, namely endurance and resistance training', 'endurance training, (b) a resistance training or (c) to an active control condition', 'exercise training', 'regular exercise training']","['questionnaires covering sociodemographic information, QoL, sleep quality and sleep patterns, coping with stress, state- and trait-anxiety, depression, and fatigue', 'quality of life (QoL', 'Hamilton Depression Rating Scale', 'psychological well-being, sleep, quality of life and physical fitness', 'physical fitness and dimensions of well-being, and sleep', 'psychological well-being, sleep, QoL and physical fitness', 'Aerobic exercise performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]",45.0,0.0593092,"Importantly, unlike the majority of previous studies, the control condition consists of an active set-up to detect possible factual beneficial effects of exercise training, irrespective of social interactions.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Cordier', 'Affiliation': 'Department of Neurosurgery, University Hospital Basel, 4031, Basel, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Division of Sport and Psychosocial Health, Department of Sport, Exercise and Health, University of Basel, 4052, Basel, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Division of Sport and Psychosocial Health, Department of Sport, Exercise and Health, University of Basel, 4052, Basel, Switzerland. serge.brand@upkbs.ch.'}]","Cancer communications (London, England)",['10.1186/s40880-019-0390-8']
760,30353208,The effect of post-operative limb positioning on blood loss and early outcomes after primary total knee arthroplasty: a randomized controlled trial.,"INTRODUCTION


The purpose of this study was to investigate the benefits of three different post-operative limb positions in primary total knee arthroplasty (TKA).
METHODS


The trial was a single-surgeon, randomized, controlled trial, and 135 patients following primary TKA were randomized into three groups: group A (45 patients who were treated with the hip fixed at 50° and knee flexed at 90° for 6 hours post-operatively), group B (45 patients who were treated with the hip elevated at 30° and knee flexed at 45° for 6 hours  post-operatively), and group C (45 patients in whom the affected knee was fully extended after surgery). Tranexamic acid was used in all patients.
RESULTS


The total blood loss and hidden blood loss in group A (921 ± 209 mL, 597 ± 213 mL) were significantly less than in groups B (1125 ± 222 mL, 784 ± 229 mL) and C (1326 ± 291 mL, 915 ± 301 mL) and less in group B compared with group C. The drain volume in groups A (158 ± 35 mL) and B (174 ± 45 mL) was significantly lower than in group C (249 ± 31 mL). The maximum haemoglobin drop in group A (3.1 ± 0.5 g/dL) was statistically significantly less than in groups B (3.6 ± 0.7 g/dL) and C (4.3 ± 0.4 g/dL). The range of motion (ROM) in groups A (102 ± 3°, 105 ± 2°) and B (100 ± 3°, 104 ± 2°) was significantly better than in group C (98 ± 3°, 102 ± 2°) at the time of discharge and one  month after surgery; it was also significantly less for group A (104.9 ± 2.1%, 108.0 ± 2.4%) compared with groups B (106.7 ± 3.1%, 108.3 ± 2.7%) and C (108.4 ± 3.2%, 110.6 ± 3.0%) with post-operative knee swelling. No differences in transfusion requirements and complications were observed among the three groups.
CONCLUSIONS


The affected knee flexion position was superior to the use of a fully extended position for blood management, but it only contributed to better early functional recovery up to three  months post-operatively in TKA. In addition, by fixing the affected knee at a high flexion position of 90°, patients could achieve less blood loss, lower knee swelling, and better early results for ROM and patient satisfaction than the other two groups.",2019,The drain volume in groups A (158 ± 35 mL) and B (174 ± 45 mL) was significantly lower than in group C (249 ± 31 mL).,"['primary total knee arthroplasty (TKA', 'primary total knee arthroplasty', '135 patients following primary TKA']","['hip fixed at 50° and knee flexed at 90° for 6\xa0hours post-operatively', 'Tranexamic acid', 'post-operative limb positioning']","['transfusion requirements and complications', 'blood loss, lower knee swelling, and better early results for ROM and patient satisfaction', 'maximum haemoglobin', 'blood loss and early outcomes', 'range of motion (ROM', 'drain volume', 'total blood loss and hidden blood loss']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}]",,0.0673128,The drain volume in groups A (158 ± 35 mL) and B (174 ± 45 mL) was significantly lower than in group C (249 ± 31 mL).,"[{'ForeName': 'Yuangang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Canfeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Qinsheng', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, China. shenbin_1971@163.com.'}]",International orthopaedics,['10.1007/s00264-018-4174-6']
761,31225739,The Effect of Two Types of Pasta Versus White Rice on Postprandial Blood Glucose Levels in Adults with Type 1 Diabetes: A Randomized Crossover Trial.,"Background:  Food choices are essential to successful glycemic control for people with diabetes. We compared the impact of three carbohydrate-rich meals on the postprandial glycemic response in adults with type 1 diabetes (T1D).  Methods:  We performed a randomized crossover study in 12 adults with T1D (age 58.7 ± 14.2 years, baseline hemoglobin A1c 7.5% ± 1.3%) comparing the postprandial glycemic response to three meals using continuous glucose monitoring: (1) ""higher protein"" pasta containing 10 g protein/serving, (2) regular pasta with 7 g protein/serving, and (3) extra-long grain white rice. All meals contained 42 g carbohydrate; were served with homemade tomato sauce, green salad, and balsamic dressing; and were repeated twice in random order. After their insulin bolus, subjects were observed in clinic for 5 h. Linear mixed effects models were used to assess the glycemic response.  Results:  Compared with white rice, peak glucose levels were significantly lower for higher protein pasta (-32.6 mg/dL; 95% CI -48.4 to -17.2;  P  < 0.001) and regular pasta (-43.2 mg/dL, 95% CI -58.7 to -27.7;  P  < 0.001). The difference between the two types of pastas did not reach statistical significance (-11 mg/dL; 95% CI -24.1 to 3.4;  P  = 0.17). Total glucose area under the curve was also significantly higher for white rice compared with both pastas ( P  < 0.001 for both comparisons).  Conclusions:  This exploratory study concluded that different food types of similar macronutrient content (e.g., rice and pasta) generate significantly different postprandial glycemic responses in persons with T1D. These results provide useful insights into the impact of food choices on and optimization of glucose control. Clinical Trial Registry: clinicaltrials.gov NCT03362151.",2019,Total glucose area under the curve was also significantly higher for white rice compared with both pastas ( P  < 0.001 for both comparisons).  ,"['adults with type 1 diabetes (T1D', 'people with diabetes', '12 adults with T1D (age 58.7\u2009±\u200914.2 years, baseline hemoglobin A1c 7.5%\u2009±\u20091.3%) comparing the', 'persons with T1D', 'Adults with Type 1 Diabetes']","['postprandial glycemic response to three meals using continuous glucose monitoring: (1) ""higher protein"" pasta containing 10\u2009g protein/serving, (2) regular pasta with 7\u2009g protein/serving, and (3) extra-long grain white rice', 'All meals contained 42\u2009g carbohydrate; were served with homemade tomato sauce, green salad, and balsamic dressing', 'Pasta Versus White Rice', 'carbohydrate-rich meals']","['Postprandial Blood Glucose Levels', 'postprandial glycemic response', 'Total glucose area under the curve', 'postprandial glycemic responses', 'regular pasta', 'glycemic response', 'peak glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0452712', 'cui_str': 'White rice (substance)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0453373', 'cui_str': 'Tomato sauce (substance)'}, {'cui': 'C0453751', 'cui_str': 'Green salad (substance)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",12.0,0.0603818,Total glucose area under the curve was also significantly higher for white rice compared with both pastas ( P  < 0.001 for both comparisons).  ,"[{'ForeName': 'Stamatina', 'Initials': 'S', 'LastName': 'Zavitsanou', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Massa', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Deshpande', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Andre', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle Iii', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Michelson', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Creason', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0109']
762,31230933,"Incidence, determinants and impact of acute kidney injury in patients with diabetes mellitus and multivessel disease undergoing coronary revascularization: Results from the FREEDOM trial.","BACKGROUND


The incidence and prognostic significance of acute kidney injury (AKI) in patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization is not well known. The current analysis included patients randomized to PCI vs. CABG as part of the FREEDOM trial. We sought to examine the impact of AKI and its predictors in diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG.
METHODS


We conducted a pre-specified subgroup analysis of the FREEDOM trial to examine the incidence, correlates and impact of AKI according to revascularization strategy. AKI predictors were identified using multivariable logistic regression and associations between AKI and outcomes were examined using Cox regression. The primary endpoint was the composite occurrence of all-cause death, stroke or myocardial infarction at 5 years of follow-up.
RESULTS


KI occurred more frequently in patients following CABG (15.6%) compared with PCI (9.1%) (p < 0.001). AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001). There was a non-significant interaction (p-value = 0.89) between the revascularization method and AKI, supporting that AKI is a significant risk factor in both revascularization methods.
CONCLUSIONS


Although risk for AKI was higher in patients undergoing CABG, the impact of AKI on MACE was substantial irrespective of revascularization strategy. Preventive strategies to identify patients at risk for AKI are warranted to mitigate the long-term effects of this complication.",2019,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","['patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization', 'diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG', 'patients with diabetes mellitus and multivessel disease undergoing coronary revascularization']",['PCI vs. CABG'],"['composite occurrence of all-cause death, stroke or myocardial infarction at 5\u202fyears of follow-up', 'higher risk for major cardiovascular events (MACE', 'KI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.272116,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Arbel', 'Affiliation': 'Department of Cardiology, Tel Aviv Medical Center, Affiliated with the University of Tel Aviv, Tel Aviv, Israel. Electronic address: yarona@tlvmc.gov.il.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Taye H', 'Initials': 'TH', 'LastName': 'Hamza', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Siami', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Canada.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.05.064']
763,31564601,Home Visit Intervention Promotes Lifestyle Changes: Results of an RCT in Mexican Americans.,"INTRODUCTION


Hispanic populations are less likely that other ethnicities to meet physical activity guidelines. Community health worker (CHW) outreach is an effective delivery method for behavior change messages owing to shared culture, language, and life experience. This study examined the efficacy of a CHW-delivered intervention, Tu Salud ¡Si Cuenta! (Your Health Matters!) at Home Intervention, to promote physical activity among Mexican Americans.
STUDY DESIGN


RCT.
SETTING AND PARTICIPANTS


Mexican Americans living along the Texas-Mexico border from June 2010 to April 2013.
INTERVENTION


Eligible adults were randomized into intervention (n=250) or standard care (n=250). Intervention participants received 6 monthly CHW visits that included education, motivation, and support for lifestyle changes. Standard care was potentially exposed to a community-wide health promotion campaign. Data were collected at baseline and 6- and 12-month follow-ups.
MAIN OUTCOME MEASURES


Meeting physical activity guidelines was defined as ≥600 MET-adjusted minutes of moderate and vigorous exercise.
RESULTS


Intervention participants were more likely to meet physical activity guidelines at 6 months (AOR=2.02, 95% CI=1.25, 3.26) than standard care, but the significance was not maintained at 12 months (AOR=1.53, 95% CI=0.92, 2.53). The results were similar in the as-treated and obesity-stratified analyses. The secondary analysis corroborated the primary results.
CONCLUSIONS


This study shows increases in physical activity among those exposed to a CHW intervention, including participants with obesity. It also indicates that the removal of CHW contact tapers the effect at 12 months.
TRIAL REGISTRATION


NCT01168765.",2019,"RESULTS


Intervention participants were more likely to meet physical activity guidelines at 6 months (AOR=2.02, 95% CI=1.25, 3.26) than standard care, but the significance was not maintained at 12 months (AOR=1.53, 95% CI=0.92, 2.53).","['participants with obesity', 'Mexican Americans', 'Mexican Americans living along the Texas-Mexico border from June 2010 to April 2013']","['6 monthly CHW visits that included education, motivation, and support for lifestyle changes', 'CHW intervention', 'CHW-delivered intervention, Tu Salud ¡', 'Home Visit Intervention', 'Si Cuenta', 'Community health worker (CHW) outreach']","['meet physical activity guidelines', 'physical activity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",,0.0365857,"RESULTS


Intervention participants were more likely to meet physical activity guidelines at 6 months (AOR=2.02, 95% CI=1.25, 3.26) than standard care, but the significance was not maintained at 12 months (AOR=1.53, 95% CI=0.92, 2.53).","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Vidoni', 'Affiliation': 'Biostatistics, Epidemiology, and Research Design (BERD) Core, Center for Clinical and Translational Sciences (CCTS), University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'MinJae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Biostatistics, Epidemiology, and Research Design (BERD) Core, Center for Clinical and Translational Sciences (CCTS), University of Texas Health Science Center at Houston, Houston, Texas; Department of Internal Medicine, Division of Clinical and Translational Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mitchell-Bennett', 'Affiliation': 'Health Promotion and Behavioral Sciences, Hispanic Health Research Center, University of Texas School of Public Health Brownsville Regional Campus, Brownsville, Texas.'}, {'ForeName': 'Belinda M', 'Initials': 'BM', 'LastName': 'Reininger', 'Affiliation': 'Health Promotion and Behavioral Sciences, Hispanic Health Research Center, University of Texas School of Public Health Brownsville Regional Campus, Brownsville, Texas. Electronic address: belinda.m.reininger@uth.tmc.edu.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.020']
764,30684213,"The Impact of a Preventive Intervention on Persistent, Cross-Situational Early Onset Externalizing Problems.","The Nurse-Family Partnership (NFP) home visiting intervention for low-income first-time mothers was evaluated for its preventive impact on persistent, cross-situational early-onset externalizing problems (EXT). Seven hundred thirty-five women in the Denver, CO, area were randomly assigned into one of two active conditions (nurse or paraprofessional home visiting from pregnancy through child age 2) or a control group in which children were screened and referred for behavioral and developmental problems. Externalizing behavior was assessed by parent report when the children were 2, 4, 6, and 9 years old; teachers provided reports at ages 6 and 9. Latent profile analyses suggested the presence of persistent, cross-situational early onset EXT in approximately 6 to 7% of girls and boys. The intervention deflected girls away from these EXT and toward a pattern marked by a persistent moderate elevation of externalizing behavior that was evident at home and not at school. This finding should be interpreted cautiously given the small number of girls with the elevated EXT. Surprisingly, the intervention also moved girls away from stable low level externalizing behavior toward the moderately elevated pattern. Both of the significant effects on girls' externalizing behavior were modest. No statistically significant effects were found for boys' externalizing behaviors, which exhibited a somewhat different patterning across time and reporter. Effect sizes were generally similar for the nurse and paraprofessional-visited groups. The results are discussed in the context of prior efforts to prevent early EXT and emerging evidence on the normative development of externalizing behavior.",2019,"No statistically significant effects were found for boys' externalizing behaviors, which exhibited a somewhat different patterning across time and reporter.","['Seven hundred thirty-five women in the Denver, CO, area']","['Nurse-Family Partnership (NFP) home visiting intervention', 'active conditions (nurse or paraprofessional home visiting from pregnancy through child age 2) or a control group', 'Preventive Intervention']","['externalizing behavior', 'Externalizing behavior', ""girls' externalizing behavior"", ""boys' externalizing behaviors""]","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]",735.0,0.0247379,"No statistically significant effects were found for boys' externalizing behaviors, which exhibited a somewhat different patterning across time and reporter.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Lorber', 'Affiliation': 'New York University, New York City, NY, USA. lorber2@gmail.com.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Olds', 'Affiliation': 'University of Colorado at Denver Health Sciences Center, Denver, CO, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Donelan-McCall', 'Affiliation': 'University of Colorado at Denver Health Sciences Center, Denver, CO, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0973-7']
765,31152309,Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients.,"PURPOSE


Nature is a phenomenal treasure of remedies. Numerous previous studies reported that Nigella sativa NS improved glycemic control, reduced insulin resistance, and improved lipid profile. NS was never investigated before as a monotherapy for newly diagnosed type 2 diabetes mellitus T2DM patients. Our aim was to investigate the potential metabolic benefits of NS monotherapy in newly diagnosed T2DM patients.
METHOD


Prospective, open-label randomized clinical trial at outpatient endocrinology clinic at Ain-Shams University hospital. Eligible patients were randomly assigned to either metformin tablets or NS oil capsules. Both groups received treatment for 3 months. Glycemic index (FBG, 2 h pp, A1C, insulin sensitivity %S, secretory function %B, insulin resistance IR), lipid profile (TC, LDL, HDL, TG), liver and kidney functions (AST, ALT, Sr cr), total antioxidant capacity TAC, weight, waist circumference WC and body mass index BMI were assessed at baseline and at the end of treatment period.
RESULTS


A concentration of 1350 mg/day NS in newly diagnosed T2DM patients was inferior to metformin in terms of lowering FBG, 2 h pp, and A1C or increasing %B. However, NS was comparable to metformin in lowering weight, WC, and BMI significantly. NS was comparable to metformin in regards of their effects on fasting insulin, %S, IR, ALT, TC, LDL, HDL, TG, and TAC. Metformin showed significant increase in AST and creatinine which was reserved in NS group.
CONCLUSION


NS administration in newly diagnosed T2DM was tolerable with no side effects as compared to metformin; however, it was inferior to metformin in terms of diabetes management.",2019,"NS was comparable to metformin in regards of their effects on fasting insulin, %S, IR, ALT, TC, LDL, HDL, TG, and TAC.","['newly diagnosed T2DM patients', 'newly diagnosed type 2 diabetes mellitus patients', 'Eligible patients', 'outpatient endocrinology clinic at Ain-Shams University hospital', 'newly diagnosed type 2 diabetes mellitus T2DM patients']","['Nigella Sativa oil versus metformin', 'metformin', 'NS monotherapy', 'Metformin', 'metformin tablets or NS oil capsules']","['AST and creatinine', 'glycemic control, reduced insulin resistance, and improved lipid profile', 'Glycemic index (FBG, 2\u2009h pp, A1C, insulin sensitivity %S, secretory function %B, insulin resistance IR), lipid profile (TC, LDL, HDL, TG), liver and kidney functions (AST, ALT, Sr cr), total antioxidant capacity TAC, weight, waist circumference WC and body mass index BMI', 'lowering weight, WC, and BMI', 'glycemic control and biochemical parameters', 'fasting insulin, %S, IR, ALT, TC, LDL, HDL, TG, and TAC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C3651714', 'cui_str': 'caraway black oil'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.021184,"NS was comparable to metformin in regards of their effects on fasting insulin, %S, IR, ALT, TC, LDL, HDL, TG, and TAC.","[{'ForeName': 'Hebatallah Ahmed Mohamed', 'Initials': 'HAM', 'LastName': 'Moustafa', 'Affiliation': 'Department of pharmacy practice, Faculty of Pharmacy and drug technology, Heliopolis University for Sustainable Development, Cairo Governorate, Egypt.'}, {'ForeName': 'Lamia Mohamed', 'Initials': 'LM', 'LastName': 'El Wakeel', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of pharmacy, Ain Shams University, Cairo Governorate, Egypt. lamywak@yahoo.com.'}, {'ForeName': 'Mohamed Reda', 'Initials': 'MR', 'LastName': 'Halawa', 'Affiliation': 'Department of Internal Medicine and Endocrinology, Faculty of Pharmacy, Ain Shams University, Cairo Governorate, Egypt.'}, {'ForeName': 'Nagwa Ali', 'Initials': 'NA', 'LastName': 'Sabri', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of pharmacy, Ain Shams University, Cairo Governorate, Egypt.'}, {'ForeName': 'Alshaymaa Zaki', 'Initials': 'AZ', 'LastName': 'El-Bahy', 'Affiliation': 'Department of pharmacology & toxicology, faculty of pharmacy and drug technology, Heliopolis University for Sustainable Development, Cairo Governorate, Egypt.'}, {'ForeName': 'Abdel Nasser', 'Initials': 'AN', 'LastName': 'Singab', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, Ain Shams University, Cairo Governorate, Egypt.'}]",Endocrine,['10.1007/s12020-019-01963-4']
766,31182440,Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial.,"INTRODUCTION


The aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).
METHODS AND ANALYSIS


A randomised double-blinded controlled clinical trial will be conducted, involving 200 patients with CLBP. Participants will be randomised in a 1:1 ratio to receive either active PLFMF (experimental arm) or sham treatment (control arm) using a permuted-block design which will be stratified according to three subtypes of musculoskeletal CLBP (nociceptive, peripheral neuropathic or central sanitisation). The intervention consists of three sessions/week for 6 weeks. The primary outcome is the percentage change in Numerical Rating Scale (NRS) pain at week 24 after treatment completion with respect to the baseline. Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale. Measures will be taken at baseline, 3 and 6 weeks during the intervention and 6, 12 and 24 weeks after completing the intervention. Adverse events between arms will be evaluated. Data will be analysed on an intention-to-treat basis.
ETHICS AND DISSEMINATION


The study is funded by Imam Abdulrahman Bin Faisal University (IAU). It has been approved by the institutional review board of IAU (IRB- 2017-03-129). The study will be conducted at King Fahd Hospital of the University and will be monitored by the Hospital monitoring office for research and research ethics. The trial is scheduled to begin in September 2018. Results obtained will be presented in international conferences and will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ACTRN12618000921280, prospectively.",2019,"Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale.","['patients with musculoskeletal chronic low back pain', '200 patients with CLBP', 'chronic low back pain (CLBP', 'funded by Imam Abdulrahman Bin Faisal University (IAU']","['pulsed low-frequency magnetic field therapy', 'pulsed low-frequency magnetic field (PLFMF', 'active PLFMF (experimental arm) or sham treatment (control arm', 'placebo']","['percentage change in Numerical Rating Scale (NRS) pain', 'Adverse events', 'pain intensity', 'percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale (assessment scale)'}]",200.0,0.388145,"Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale.","[{'ForeName': 'Fuad A', 'Initials': 'FA', 'LastName': 'Abdulla', 'Affiliation': 'Department of Physical Therapy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alsaadi', 'Affiliation': 'Department of Physical Therapy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Mir', 'Initials': 'M', 'LastName': 'Sadat-Ali', 'Affiliation': 'Department of Orthopedic Surgery, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Fahd', 'Initials': 'F', 'LastName': 'Alkhamis', 'Affiliation': 'Department of Neurology, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Alkawaja', 'Affiliation': 'Department of Physical Therapy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Serigne', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Institute of Research and Medical Consultation, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",BMJ open,['10.1136/bmjopen-2018-024650']
767,30897499,"Family environment, children's acculturation and mothers' dietary intake and behaviors among Latinas: An autoregressive cross-lagged study.","BACKGROUND


Many Latinos in the U.S. do not meet dietary recommendations for healthy eating. Family systems theory posits that the family environment affects family members' dietary behaviors. Moreover, research suggests that children's acculturation is associated with Latina mothers' dietary intake and behaviors.
PURPOSE


This longitudinal study examined the effect of the family environment on Latina mothers' dietary intake and behaviors. Further, we examined whether these effects differed between mothers of assimilated versus bicultural children.
METHODS


Secondary data were collected at three time points (baseline, and four and 10 months' post-baseline) from 162 culturally traditional and bicultural Latina mothers residing in Imperial County, California, U.S. Participants were enrolled in the delayed treatment group of a randomized controlled trial. Mothers' daily fruit, vegetable, and sugary beverages intake, percent of calories from fat, weekly away-from-home eating, and percent of weekly grocery dollars spent on fruits and vegetables were examined. The family environment was measured by family expressiveness and family interactions around food. Separate autoregressive cross-lagged models examined the effects of the family environment on dietary outcomes, adjusting for sociodemographic variables. Interactions between the family environment and children's acculturation were also tested.
RESULTS


Less positive family interactions around food at baseline predicted more frequent away-from-home eating four months later among mothers of assimilated children. More family expressiveness at four months predicted more grocery dollars spent on fruits and vegetables at ten months among mothers of bicultural children.
CONCLUSIONS


Findings suggest the importance of a positive family environment on socially-bound dietary behaviors (e.g., away-from-home eating) exhibited by the mother. Family interventions aimed at improving dietary intake and associated behaviors should promote a positive family environment around food and consider the moderating role of children's acculturation.",2019,"More family expressiveness at four months predicted more grocery dollars spent on fruits and vegetables at ten months among mothers of bicultural children.
","[""Secondary data were collected at three time points (baseline, and four and 10 months' post-baseline) from 162 culturally traditional and bicultural Latina mothers residing in Imperial County, California, U.S. Participants were enrolled in the delayed treatment group of a randomized controlled trial"", ""Family environment, children's acculturation and mothers' dietary intake and behaviors among Latinas"", ""Latina mothers' dietary intake and behaviors"", 'healthy eating']",[],['grocery dollars spent on fruits and vegetables'],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000943', 'cui_str': 'Acculturation'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",[],"[{'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",162.0,0.0225643,"More family expressiveness at four months predicted more grocery dollars spent on fruits and vegetables at ten months among mothers of bicultural children.
","[{'ForeName': 'Sandra H', 'Initials': 'SH', 'LastName': 'Soto', 'Affiliation': 'University of North Carolina, Chapel Hill, School of Nursing, Carrington Hall, Campus Box #7460 Chapel Hill, NC, 27599, USA. Electronic address: shsoto@live.unc.edu.'}, {'ForeName': 'Elva M', 'Initials': 'EM', 'LastName': 'Arredondo', 'Affiliation': 'Institute for Behavioral and Community Health, 9245 Sky Park Court, Suite 221, San Diego, CA, 92123, USA; San Diego State University, College of Health and Human Services, Graduate School of Public Health, Division of Health Promotion and Behavioral Science, 5500 Campanile Drive, San Diego, CA, 92182, USA. Electronic address: earredon@sdsu.edu.'}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Shakya', 'Affiliation': 'University of California, San Diego, USA; Department of Medicine, Division of Global Health, 9500 Gilman Drive, La Jolla, CA, 92093, USA. Electronic address: hshakya@ucsd.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'San Diego State University, College of Sciences, Department of Psychology, 5500 Campanile Drive, San Diego, CA, 92182, USA. Electronic address: sroesch@sdsu.edu.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Marcus', 'Affiliation': 'Brown University, School of Public Health, 121 S Main St, Providence, RI, 02903, USA. Electronic address: bess_marcus@brown.edu.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Parada', 'Affiliation': 'San Diego State University, College of Health and Human Services, Graduate School of Public Health, Division of Health Promotion and Behavioral Science, 5500 Campanile Drive, San Diego, CA, 92182, USA. Electronic address: hparada@sdsu.edu.'}, {'ForeName': 'Guadalupe X', 'Initials': 'GX', 'LastName': 'Ayala', 'Affiliation': 'Institute for Behavioral and Community Health, 9245 Sky Park Court, Suite 221, San Diego, CA, 92123, USA; San Diego State University, College of Health and Human Services, Graduate School of Public Health, Division of Health Promotion and Behavioral Science, 5500 Campanile Drive, San Diego, CA, 92182, USA. Electronic address: ayala@sdsu.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.017']
768,30535623,"A Randomized, Controlled Trial of the Impact of the Couple CARE for Parents of Newborns Program on the Prevention of Intimate Partner Violence and Relationship Problems.","Effective, accessible prevention programs are needed for adults at heightened risk for intimate partner violence (IPV). This parallel group randomized controlled trial examines whether such couples receiving the American version of Couple CARE for Parents of Newborns (CCP; Halford et al. 2009) following the birth of a child, compared with controls, report fewer first occurrences of clinically significant IPV, less frequent physical and psychological IPV, and improved relationship functioning. Further, we test whether intervention effects are moderated by level of risk for IPV. Couples at elevated risk for IPV (N = 368) recruited from maternity units were randomized to CCP (n = 188) or a 24-month waitlist (n = 180) and completed measures of IPV and relationship functioning at baseline, post-program (when child was 8 months old), and two follow-ups (at 15 and 24 months). Intervention effects were tested using intent to treat (ITT) as well as complier average causal effect (CACE; Jo and Muthén 2001) structural equation models. CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses. Risk moderated the effect of CCP on male-to-female physical IPV at post-program, with couples with a planned pregnancy declining, but those with unplanned pregnancies increasing. This study adds to previous findings that prevention programs for at-risk couples are not often effective and may even be iatrogenic for some couples.",2019,"CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses.","['Parents of Newborns Program on the Prevention of Intimate Partner Violence and Relationship Problems', 'couples receiving the American version of Couple CARE for Parents of Newborns (CCP; Halford et al', 'Couples at elevated risk for IPV (N\u2009=\u2009368) recruited from maternity units', 'adults at heightened risk for intimate partner violence (IPV']","['Couple CARE', 'CCP']","['frequent physical and psychological IPV, and improved relationship functioning']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0905814,"CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Heyman', 'Affiliation': 'New York University, New York, NY, USA. Richard.Heyman@NYU.edu.'}, {'ForeName': 'Amy M Smith', 'Initials': 'AMS', 'LastName': 'Slep', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Lorber', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Mitnick', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Katherine J W', 'Initials': 'KJW', 'LastName': 'Baucom', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'W Kim', 'Initials': 'WK', 'LastName': 'Halford', 'Affiliation': 'University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0961-y']
769,30536189,The Role of Culture of Origin on the Effectiveness of a Parents-Involved Intervention to Prevent Substance Use Among Latino Middle School Youth: Results of a Cluster Randomized Controlled Trial.,"The purpose of this study was to assess the combined effectiveness of a parenting intervention, Families Preparing the New Generation (FPNG), and a youth curriculum, keepin' it REAL (kiR), on substance use prevention for middle school students in a large urban metro area of the southwest USA. The study aimed to generate usable knowledge on what works in adolescent substance use prevention and how it works best-a combined parent and youth programming or parent-only programming. A total of 532 adolescents in the 7th grade from 19 participating middle schools were randomly assigned into three intervention conditions: parent-youth (PY), parent-only (PO), and comparison (C). This article focuses on the comparison between PY and PO in order to determine which intervention strategy works best to reduce adolescent substance use including alcohol, inhalant, cigarette, and marijuana uses. A generalized estimating equation (GEE) model examined the longitudinal data. The results for alcohol use show that PO yielded better results than PY and that PY outperformed C after 20 months. Further, PO showed a decreasing trajectory in any substance use over time since the implementation of the intervention. The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition. These findings have implications for the design of future culturally specific parenting and youth prevention interventions with Latino families.",2019,The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition.,"['Latino Middle School Youth', 'middle school students in a large urban metro area of the southwest USA', '532 adolescents in the 7th grade from 19 participating middle schools']","[""parenting intervention, Families Preparing the New Generation (FPNG), and a youth curriculum, keepin' it REAL (kiR"", 'intervention conditions: parent-youth (PY), parent-only (PO), and comparison (C', 'Parents-Involved Intervention']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]",[],532.0,0.0197484,The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition.,"[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'SeungYong', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA. shan32@asu.edu.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Weide', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0968-4']
770,30549358,Randomized phase II/III confirmatory treatment selection design with a change of survival end points: Statistical design of Radiation Therapy Oncology Group 1216.,"BACKGROUND


To confirm the treatment effects of concurrent cetuximab plus docetaxel observed in Radiation Therapy Oncology Group (RTOG) 0234 and single out the effect of cetuximab, we designed RTOG 1216, a randomized phase II/III study, which uses an intermediate end point to select the best regimen for definitive testing of survival benefit.
METHODS


In phase II, the best regimen should demonstrate statistically significant efficacy against the control with predefined advantage over the competing arm regarding disease-free survival (DFS). We evaluate operating characteristics of the randomized II/III group sequential design through simulations and numerical integrations under the null and various alternative hypotheses.
RESULTS


Results show the randomized II/III design yields substantial savings on sample size and time with well-controlled type I and type II error rates.
CONCLUSION


Overall, the proposed randomized II/III design has desirable properties that offer cost effectiveness, operational efficiency, and, most importantly, scientific innovation that can be considered for similar clinical research settings.",2019,"RESULTS


Results show the randomized II/III design yields substantial savings on sample size and time with well-controlled type I and type II error rates.
",[],"['cetuximab', 'concurrent cetuximab plus docetaxel']",['sample size and time with well-controlled type I and type II error rates'],[],"[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",,0.0256501,"RESULTS


Results show the randomized II/III design yields substantial savings on sample size and time with well-controlled type I and type II error rates.
","[{'ForeName': 'Qiang Ed', 'Initials': 'QE', 'LastName': 'Zhang', 'Affiliation': 'Thomas Jefferson University, Sidney Kimmel Medical College, Philadelphia, Pennsylvania.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Clinical Biostatistics, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Harari', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Head & neck,['10.1002/hed.25359']
771,31345462,"Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial.","BACKGROUND


Identifying new antifungals for cryptococcal meningitis is a priority given the inadequacy of current therapy. Sertraline has previously shown in vitro and in vivo activity against cryptococcus. We aimed to assess the efficacy and cost-effectiveness of adjunctive sertraline in adults with HIV-associated cryptococcal meningitis compared with placebo.
METHODS


In this double-blind, randomised, placebo-controlled trial, we recruited HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda. Participants were randomly assigned (1:1) to receive standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole (starting at 800 mg/day) with either adjunctive sertraline or placebo. Sertraline was administered orally or via nasogastric tube at a dose of 400 mg/day for 2 weeks, followed by 200 mg/day for 12 weeks, then tapered off over 3 weeks. The primary endpoint was 18-week survival, analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT01802385.
FINDINGS


Between March 9, 2015, and May 29, 2017, we screened 842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility. Three patients in the sertraline group and three patients in the placebo group were lost to follow-up and therefore discontinued before study end. At 18 weeks, 120 (52%) of 229 patients in the sertraline group and 106 (46%) of 231 patients in the placebo group had died (hazard ratio 1·21, 95% CI 0·93-1·57; p=0·15). The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day [95% CI 0·37-0·50] in the sertraline group vs 0·47 -log 10  CFU/mL per day [0·40-0·54] in the placebo group; p=0·59), as was occurrence of grade 4 or 5 adverse events (72 [31%] of 229 vs 75 [32%] of 231; p=0·98), most of which were associated with amphotericin B toxicity.
INTERPRETATION


Sertraline did not reduce mortality and should not be used to treat patients with HIV-associated cryptococcal meningitis. The reasons for sertraline inactivity appear to be multifactorial and might be associated with insufficient duration of therapeutic sertraline concentrations.
FUNDING


National Institutes of Health and Medical Research Council, Wellcome Trust.",2019,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day,"['group vs 0·47 -log 10', 'adults with HIV-associated cryptococcal meningitis', 'HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda', 'HIV-associated cryptococcal meningitis', 'Between March 9, 2015, and May 29, 2017', '842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility', 'patients with HIV-associated cryptococcal meningitis']","['sertraline', 'adjunctive sertraline or placebo', 'standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole', 'Adjunctive sertraline', 'placebo', 'adjunctive sertraline', 'Sertraline']","['18-week survival, analysed by intention-to-treat', 'amphotericin B toxicity', 'efficacy and cost-effectiveness', 'fungal clearance rate from cerebrospinal fluid', 'occurrence of grade 4 or 5 adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0086322', 'cui_str': 'Futility'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",550.0,0.816271,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rhein', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda. Electronic address: joshua.rhein@gmail.com.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Huppler Hullsiek', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Tugume', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Nuwagira', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mpoza', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Kiggundu', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ssebambulidde', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Akampurira', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Abdu K', 'Initials': 'AK', 'LastName': 'Musubire', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda; School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30127-6']
772,30928969,Effect of communicating phenotypic and genetic risk of coronary heart disease alongside web-based lifestyle advice: the INFORM Randomised Controlled Trial.,"OBJECTIVE


To determine whether provision of web-based lifestyle advice and coronary heart disease risk information either based on phenotypic characteristics or phenotypic plus genetic characteristics affects changes in objectively measured health behaviours.
METHODS


A parallel-group, open randomised trial including 956 male and female blood donors with no history of cardiovascular disease (mean [SD] age=56.7 [8.8] years) randomised to four study groups: control group (no information provided); web-based lifestyle advice only (lifestyle group); lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic characteristics (phenotypic risk estimate) (phenotypic group) and lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic (phenotypic risk estimate) and genetic characteristics (genetic risk estimate) (genetic group). The primary outcome was change in physical activity from baseline to 12 weeks assessed by wrist-worn accelerometer.
RESULTS


928 (97.1%) participants completed the trial. There was no evidence of intervention effects on physical activity (difference in adjusted mean change from baseline): lifestyle group vs control group 0.09 milligravity (mg) (95% CI -1.15 to 1.33); genetic group vs phenotypic group -0.33 mg (95% CI -1.55 to 0.90); phenotypic group and genetic group vs control group -0.52 mg (95% CI -1.59 to 0.55) and vs lifestyle group -0.61 mg (95% CI -1.67 to 0.46). There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
CONCLUSIONS


Provision of risk information, whether based on phenotypic or genotypic characteristics, alongside web-based lifestyle advice did not importantly affect objectively measured levels of physical activity, other health-related behaviours, biological risk factors or emotional well-being.
TRIAL REGISTRATION NUMBER


ISRCTN17721237; Pre-results.",2019,"There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
","['956 male and female blood donors with no history of cardiovascular disease (mean [SD] age=56.7 [8.8] years', '928 (97.1%) participants completed the trial']","['control group (no information provided); web-based lifestyle advice only (lifestyle group); lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic characteristics (phenotypic risk estimate) (phenotypic group) and lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic (phenotypic risk estimate) and genetic characteristics (genetic risk estimate) (genetic group', 'coronary heart disease alongside web-based lifestyle advice']","['change in physical activity', 'wrist-worn accelerometer', 'physical activity, other health-related behaviours, biological risk factors or emotional well-being', 'physical activity', 'secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior (observable entity)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",956.0,0.214895,"There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
","[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Silarova', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Cambridge, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Rupert A', 'Initials': 'RA', 'LastName': 'Payne', 'Affiliation': 'University of Bristol Centre for Academic Primary Care, Bristol, Bristol, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Shefer', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Girling', 'Affiliation': 'Patient and Public Involvement representative, Cambridge, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Patient and Public Involvement representative, Cambridge, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Tolkien', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Butterworth', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Di Angelantonio', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Danesh', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-314211']
773,31088511,Effects of intensity of electroacupuncture on chronic pain in patients with knee osteoarthritis: a randomized controlled trial.,"BACKGROUND


Conditioned pain modulation (CPM) is impaired in people with chronic pain such as knee osteoarthritis (KOA). The purpose of this randomized, controlled clinical trial was to investigate whether strong electroacupuncture (EA) was more effective on chronic pain by strengthening the CPM function than weak EA or sham EA in patients with KOA.
METHODS


In this multicenter, three-arm parallel, single-blind randomized controlled trial, 301 patients with KOA were randomly assigned. Patients were randomized into three groups based on EA current intensity: strong EA (> 2 mA), weak EA (< 0.5 mA), and sham EA (non-acupoint). Treatments consisted of five sessions per week, for 2 weeks. Primary outcome measures were visual analog scale (VAS), CPM function, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
RESULTS


Three hundred one patients with KOA were randomly assigned, among which 271 (90.0%) completed the study (mean age 63.93 years old). One week of EA had a clinically important improvement in VAS and WOMAC but not in CPM function. After 2 weeks treatment, EA improved VAS, CPM, and WOMAC compared with baseline. Compared with sham EA, weak EA (3.8; 95% CI 3.45, 4.15; P < .01) and strong EA (13.54; 95% CI 13.23, 13.85; P < .01) were better in improving CPM function. Compared with weak EA, strong EA was better in enhancing CPM function (9.73; 95% CI 9.44, 10.02; P < .01), as well as in reducing VAS and total WOMAC score.
CONCLUSION


EA should be administered for at least 2 weeks to exert a clinically important effect on improving CPM function of KOA patients. Strong EA is better than weak or sham EA in alleviating pain intensity and inhibiting chronic pain.
TRIAL REGISTRATION


This study was registered with the Chinese Clinical Trial Registry ( ChiCTR-ICR-14005411 ), registered on 31 October 2014.",2019,"Compared with weak EA, strong EA was better in enhancing CPM function (9.73; 95% CI 9.44, 10.02; P < .01), as well as in reducing VAS and total WOMAC score.
","['patients with KOA', 'patients with knee osteoarthritis', '301 patients with KOA', 'people with chronic pain such as knee osteoarthritis (KOA', 'Three hundred one patients with KOA were randomly assigned, among which 271 (90.0%) completed the study (mean age 63.93\u2009years old']","['electroacupuncture', 'strong electroacupuncture (EA', 'sham EA', 'Conditioned pain modulation (CPM', 'EA current intensity: strong EA (>\u20092\u2009mA), weak EA (<\u20090.5\u2009mA), and sham EA (non-acupoint', 'EA or sham EA']","['alleviating pain intensity', 'chronic pain', 'visual analog scale (VAS), CPM function, and Western Ontario and McMaster Universities Osteoarthritis Index', 'enhancing CPM function', 'VAS and total WOMAC score', 'EA improved VAS, CPM, and WOMAC', 'VAS and WOMAC', 'CPM function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",301.0,0.302677,"Compared with weak EA, strong EA was better in enhancing CPM function (9.73; 95% CI 9.44, 10.02; P < .01), as well as in reducing VAS and total WOMAC score.
","[{'ForeName': 'Zheng-Tao', 'Initials': 'ZT', 'LastName': 'Lv', 'Affiliation': 'Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Shen', 'Affiliation': 'Combined Traditional Chinese and Western Medicine Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Zhao-Qing', 'Initials': 'ZQ', 'LastName': 'Zhang', 'Affiliation': 'The Third Hospital of Wuhan, Wuhan, 430060, China.'}, {'ForeName': 'Chao-Yang', 'Initials': 'CY', 'LastName': 'Ma', 'Affiliation': 'Central Hospital of Wuhan, Wuhan, 430014, China.'}, {'ForeName': 'Guo-Fu', 'Initials': 'GF', 'LastName': 'Huang', 'Affiliation': 'Combined Traditional Chinese and Western Medicine Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'The Third Hospital of Wuhan, Wuhan, 430060, China.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Yu', 'Affiliation': 'Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Si-Yi', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Ming-Qiao', 'Initials': 'MQ', 'LastName': 'Ding', 'Affiliation': 'The Fifth Hospital of Wuhan, Wuhan, 430050, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Xiao-Cui', 'Initials': 'XC', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Jing', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China. jxhtjb@263.net.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China. liman73@mails.tjmu.edu.cn.'}]",Arthritis research & therapy,['10.1186/s13075-019-1899-6']
774,30801436,Exercise Training in Patients With Non-Small Cell Lung Cancer During In-Hospital Chemotherapy Treatment: A RANDOMIZED CONTROLLED TRIAL.,"PURPOSE


The aim of this study was to perform a randomized trial to assess the impact of exercise training in patients with non-small cell lung cancer during chemotherapy on several outcomes in comparison to a control group (CG).
METHODS


The exercise training group (ETG) consisted of 20 patients and the CG consisted of 10 patients. In the ETG, a 4-wk in-hospital exercise training program was performed in 2-wk cycles interspersed with consecutive rounds of chemotherapy with cytostatic drugs. The exercise training program was individualized and included warm-up, respiratory muscle exercise, training on a cycle ergometer or treadmill, and Nordic walking. CG participants were assessed before and after 6 wk of chemotherapy alone.
RESULTS


Comparing pre- and post-intervention values, the ETG demonstrated an increase in 6-min walk distance (486 ± 92 vs 531 ± 103 m, P = .01). In a battery of physical performance tests: Up and Go Test (6.3 ± 1.0 vs 6.0 ± 1.1 sec, P = .01); chair stand (13.3 ± 2.8 vs 14.3 ± 3.4 repetitions, P = .001); and arm curl (18.4 ± 3.1 vs 20.4 ± 3.5 repetitions, P = .001) all improved significantly. Spirometry values also improved: FEV1 % predicted (76 ± 16 vs 84 ± 15, P = .01), FVC % predicted (87 ± 14 vs 95 ± 13, P = .01), and FEV1/FVC (73 ± 13% vs 76 ± 12%, P = .04). The exercise training was well tolerated, without any adverse events due to exercise. There were no significant improvements in the CG.
CONCLUSIONS


This study suggests that planned, individualized, and supervised exercise programs in patients with advanced lung cancer during chemotherapy are a practical and beneficial intervention for enhancing mobility and physical fitness.",2019,"Spirometry values also improved: FEV1 % predicted (76 ± 16 vs 84 ± 15, P = .01), FVC % predicted (87 ± 14 vs 95 ± 13, P = .01), and FEV1/FVC (73 ± 13% vs 76 ± 12%, P = .04).","['patients with advanced lung cancer during', 'patients with non-small cell lung cancer during chemotherapy on several outcomes in comparison to a control group (CG', 'Patients With Non-Small Cell Lung Cancer']","['Hospital Chemotherapy Treatment', 'Exercise Training', 'chemotherapy', 'exercise training', 'exercise training group (ETG', 'exercise training program was individualized and included warm-up, respiratory muscle exercise, training on a cycle ergometer or treadmill, and Nordic walking']","['6-min walk distance', 'CG', 'Spirometry values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0297966,"Spirometry values also improved: FEV1 % predicted (76 ± 16 vs 84 ± 15, P = .01), FVC % predicted (87 ± 14 vs 95 ± 13, P = .01), and FEV1/FVC (73 ± 13% vs 76 ± 12%, P = .04).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutkowska', 'Affiliation': 'Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland (Drs Rutkowska, Rutkowski, and Szczegielniak); School of Medicine with the Division of Dentistry, Department of Lung Diseases and Tuberculosis, Medical University of Silesia, Zabrze, Poland (Drs Jastrzebski and Ziora); Department of Physiology and Medicine of Sport (Dr Żebrowska) and Department of Individual Sport (Dr Stanula), Academy of Physical Education, Katowice, Poland; and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California (Dr Casaburi).'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Jastrzebski', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rutkowski', 'Affiliation': ''}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Żebrowska', 'Affiliation': ''}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Stanula', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Szczegielniak', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Ziora', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000410']
775,31167860,"Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function in subjects with morbid obesity: a protocol for the Obesity  s urg e ry in Tøns berg  ( O seberg) study.","INTRODUCTION


Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function.
METHODS AND ANALYSIS


Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery.
ETHICS AND DISSEMINATION


The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings.
TRIAL REGISTRATION NUMBER


NCT01778738;Pre-results.",2019,"The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery.
","['subjects with morbid obesity', 'Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway', 'Eligible patients with type 2 diabetes and obesity', '12 September 2012 (ref: 2012/1427/REK sør-øst B', 'subjects with type 2 diabetes and obesity']","['gastric bypass or sleeve gastrectomy', 'Roux-en-Y gastric bypass and sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy']","['blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index', 'proportion of participants with complete remission of type 2 diabetes']","[{'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4505129', 'cui_str': 'Superiority Trial'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",,0.0516349,"The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Borgeraas', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Kåre Inge', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Department of Transplantation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'John Olav', 'Initials': 'JO', 'LastName': 'Grimnes', 'Affiliation': 'Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Tor Olav Widerøe', 'Initials': 'TOW', 'LastName': 'Hillestad', 'Affiliation': 'Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Tor-Ivar', 'Initials': 'TI', 'LastName': 'Karlsen', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Ronette L', 'Initials': 'RL', 'LastName': 'Kolotkin', 'Affiliation': 'Quality of Life Consulting, PLLC, Durham, North Carolina, USA.'}, {'ForeName': 'Nils Petter', 'Initials': 'NP', 'LastName': 'Kvan', 'Affiliation': 'Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Biochemistry, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Lorentzen', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Njord', 'Initials': 'N', 'LastName': 'Nordstrand', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Kathrine Aagelen', 'Initials': 'KA', 'LastName': 'Seeberg', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Seip', 'Affiliation': 'Department of Medicine, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Svanevik', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Tone Gretland', 'Initials': 'TG', 'LastName': 'Valderhaug', 'Affiliation': 'Department of Endocrinology, Division of Medicine, Akershus University Hospital HF, Oslo, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}]",BMJ open,['10.1136/bmjopen-2018-024573']
776,31167863,Improving smoking cessation care in pregnancy at Aboriginal Medical Services: 'ICAN QUIT in Pregnancy' step-wedge cluster randomised study.,"OBJECTIVES


This study aimed to examine the impact of the 'ICAN QUIT in Pregnancy' intervention on individual health providers (HPs) smoking cessation care (SCC) knowledge, attitudes and practices in general, and specifically regarding nicotine replacement therapy (NRT) prescription.
DESIGN


Step-wedge clustered randomised controlled study. HPs answered a preintervention and 1-6 months postintervention survey.
SETTING


Six Aboriginal Medical Services (AMSs) in three states of Australia.
PARTICIPANTS


All HPs were invited to participate. Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40%).
INTERVENTION


Included three 1-hour webinar sessions, educational resource package and free oral NRT.
OUTCOMES


HPs knowledge was measured using two composite scores-one from all 24 true/false statements, and one from 12 NRT-specific statements. Self-assessment of 22 attitudes to providing SCC were measured using a five-point Likert scale (Strongly disagree to Strongly agree). Two composite mean scores were calculated-one for 15 general SCC attitudes, and one for 7 NRT-specific attitudes. Self-reported provision of SCC components was measured on a five-point Likert scale (Never to Always). Feasibility outcomes, and data collected on the service and patient level are reported elsewhere.
RESULTS


Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32). Mean NRT-specific knowledge composite score also improved (68% vs 79% correct, difference 9.9, 95% CI 3.66 to 16.14). Mean attitude composite score improved (3.65 (SD 0.4) to 3.87 (SD 0.4), difference 0.23, 95% CI 0.05 to 0.41). Mean NRT-specific attitudes composite score also improved (3.37 (SD 0.6) to 3.64 (SD 0.7), difference 0.36, 95% CI 0.13 to 0.6). Self-reported practices were unchanged, including prescribing NRT.
CONCLUSIONS


A multicomponent culturally sensitive intervention in AMSs was feasible, and might improve HPs provision of SCC to pregnant Aboriginal women. Changes in NRT prescription rates may require additional intensive measures.
TRIAL REGISTRATION NUMBER


ACTRN 12616001603404; Results.",2019,"Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32).","['All HPs were invited to participate', 'Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40', 'Six Aboriginal Medical Services (AMSs) in three states of Australia', 'pregnant Aboriginal women']","['nicotine replacement therapy (NRT) prescription', 'ICAN QUIT', 'educational resource package and free oral NRT']","['Mean attitude composite score', 'Mean NRT-specific attitudes composite score', 'Mean NRT-specific knowledge composite score', 'Mean knowledge composite scores']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0199168', 'cui_str': 'Medical service (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0624628,"Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32).","[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Bar-Zeev', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bovill', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Gruppetta', 'Affiliation': 'Wollotuka Institute, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Clinical Research Design, Information Technology and Statistical Support (CReDITSS) Unit, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Clinical Research Design, Information Technology and Statistical Support (CReDITSS) Unit, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'UCL Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Reath', 'Affiliation': 'School of Medicine, Western Sydney University, Penrith South DC, New South Wales, Australia.'}, {'ForeName': 'Gillian Sandra', 'Initials': 'GS', 'LastName': 'Gould', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025293']
777,30318561,Intra-operative effect of interscalene brachial plexus block to arthroscopic rotator cuff repair surgery.,"INTRODUCTION


To determine whether the placement of an interscalene brachial plexus block (IBPB) with general anaesthesia before shoulder arthroscopy would be effective in establishing a clear visual field and in shortening the surgical procedure.
METHOD


This prospective randomized control trial study included 152 patients who had undergone arthroscopic rotator cuff repair. Group A received IBPB and group B did not receive IBPB. A visual clarity scale (VCS) was determined by arthroscopic visualization. The systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), duration of surgical procedure, VCS, and medication that was administered for haemodynamic stability were recorded.
RESULTS


The VCS was improved in group A at stages 2 and 3 of the surgical procedures (p < 0.05), but there were no significant difference at stages 1 (p = 0.288) and 4 (p = 0.062). SBP, DBP, and HR were higher in group B during surgery (p < 0.05). The administered analgesics were higher in group B (p = 0.003), but there were no differences in hypotensive agents (p = 0.287). No significant difference was observed for the duration of surgery (p = 0.704).
CONCLUSIONS


Pre-operative IBPB with general anaesthesia for arthroscopic rotator cuff repair was beneficial in maintaining haemodynamic stability and improving the VCS during surgery.",2019,"The VCS was improved in group A at stages 2 and 3 of the surgical procedures (p < 0.05), but there were no significant difference at stages 1 (p = 0.288) and 4 (p = 0.062).",['152 patients who had undergone arthroscopic rotator cuff repair'],"['IBPB and group B did not receive IBPB', 'interscalene brachial plexus block', 'interscalene brachial plexus block (IBPB', 'arthroscopic rotator cuff repair surgery']","['VCS', 'SBP, DBP, and HR', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), duration of surgical procedure, VCS, and medication that was administered for haemodynamic stability', 'duration of surgery', 'haemodynamic stability', 'hypotensive agents', 'visual clarity scale (VCS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]","[{'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0222045'}]",152.0,0.0234821,"The VCS was improved in group A at stages 2 and 3 of the surgical procedures (p < 0.05), but there were no significant difference at stages 1 (p = 0.288) and 4 (p = 0.062).","[{'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopedic Surgery, Jeju National University School of Medicine, Aran 13gil 15, Jeju National University hospital, Ara-dong, Jeju, 63241, South Korea.'}, {'ForeName': 'Taejung', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Jeju National University School of Medicine, Aran 13gil 15, Jeju National University hospital, Ara-dong, Jeju, 63241, South Korea.'}, {'ForeName': 'Yong Suk', 'Initials': 'YS', 'LastName': 'Kwon', 'Affiliation': 'Department of Orthopedic Surgery, Jeju National University School of Medicine, Aran 13gil 15, Jeju National University hospital, Ara-dong, Jeju, 63241, South Korea.'}, {'ForeName': 'Hyunseong', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedic Surgery, Jeju National University School of Medicine, Aran 13gil 15, Jeju National University hospital, Ara-dong, Jeju, 63241, South Korea. oskanghs@gmail.com.'}]",International orthopaedics,['10.1007/s00264-018-4199-x']
778,31843338,Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial.,"BACKGROUND


BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer-specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy.
OBJECTIVE


To determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants.
DESIGN, SETTING, AND PARTICIPANTS


458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder.
INTERVENTION


Patients were randomised to the chemotherapy comparison (radiotherapy, 178, or chemoradiotherapy, 182); and/or to the radiotherapy comparison (standard, 108, or reduced high-dose volume radiotherapy, 111).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patients completed Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires at baseline, end of treatment (EoT), and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary endpoint was change from baseline in the bladder cancer subscale (BLCS) at 12 months.
RESULTS AND LIMITATIONS


Data were available for 331 (92%) and 204 (93%) participants at baseline and for 192 (54%) and 114 (52%) at 12 months for the chemotherapy and radiotherapy comparisons, respectively. HRQoL declined at EoT (BLCS -5.06 [99% confidence interval: -6.12 to -4.00, p< 0.001]; overall FACT-B TOTAL score -8.22 [-10.76 to -5.68, p< 0.01]), recovering to baseline at 6 months and remaining similar to baseline subsequently. There was no significant difference between randomised groups at any time point.
CONCLUSIONS


Immediately following (chemo)radiotherapy, a significant proportion of patients report declines in HRQoL, which improve to baseline after 6 months. Two-thirds of patients report stable or improved HRQoL on long-term follow-up. There is no evidence of impairment in HRQoL resulting from the addition of chemotherapy.
PATIENT SUMMARY


Quality of life of bladder cancer patients treated with radiotherapy±chemotherapy deteriorates during treatment, but improves to at least pretreatment levels within 6 months. Addition of chemotherapy to radiotherapy does not affect patient-reported quality of life.",2020,"There was no significant difference between randomised groups at any time point.
","['458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder', 'muscle-invasive bladder cancer', 'Patients Treated for Muscle-invasive Bladder Cancer with', 'bladder cancer patients treated with', ' 178, or chemoradiotherapy, 182']","['bladder-sparing treatment', 'chemotherapy to radiotherapy', 'radiotherapy±chemotherapy deteriorates', 'Radiotherapy ± Chemotherapy', '5-fluorouracil and mitomycin C to radiotherapy', 'chemotherapy comparison (radiotherapy']","['bladder cancer subscale (BLCS', 'Quality of Life Outcomes', 'Quality of life', 'HRQoL', 'local control and bladder cancer-specific survival', 'quality of life', 'Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",458.0,0.462282,"There was no significant difference between randomised groups at any time point.
","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Huddart', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Robert.Huddart@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Crundwell', 'Affiliation': 'Royal Devon & Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Jenkins', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rawlings', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tremlett', 'Affiliation': 'Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Campani', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hendron', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Academic unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.11.001']
779,31727662,Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial.,"Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.",2019,"Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered.",['obese patients with type 2diabetes'],['Endobarrier versus standard medical therapy'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]",[],,0.12075,"Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered.","[{'ForeName': 'Aruchuna', 'Initials': 'A', 'LastName': 'Ruban', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK aruchuna@doctors.org.uk.'}, {'ForeName': 'Christina Gabriele', 'Initials': 'CG', 'LastName': 'Prechtl', 'Affiliation': 'Department of Public Health, Imperial College Healthcare NHS Trust, London, London, UK.'}, {'ForeName': 'Michael Alan', 'Initials': 'MA', 'LastName': 'Glaysher', 'Affiliation': 'Division of Surgery, Southampton Biomedical Research Centre, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Navpreet', 'Initials': 'N', 'LastName': 'Chhina', 'Affiliation': 'PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Dietician, Imperial College London, London, UK.'}, {'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolic Medicine, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'P Goldstone', 'Affiliation': 'PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care Medical Group, University of Southampton Medical School, Southampton, UK.'}, {'ForeName': 'Hutan', 'Initials': 'H', 'LastName': 'Ashrafian', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Teare', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032439']
780,31494289,Incorporation of Biologic Response Variance Modeling Into the Clinic: Limiting Risk of Brachial Plexopathy and Other Late Effects of Breast Cancer Proton Beam Therapy.,"PURPOSE


The relative biologic effectiveness (RBE) rises with increasing linear energy transfer toward the end of proton tracks. Presently, there is no consensus on how RBE heterogeneity should be accounted for in breast cancer proton therapy treatment planning. Our purpose was to determine the dosimetric consequences of incorporating a brachial plexus (BP) biologic dose constraint and to describe other clinical implications of biologic planning.
METHODS AND MATERIALS


We instituted a biologic dose constraint for the BP in the context of MC1631, a randomized trial of conventional versus hypofractionated postmastectomy intensity modulated proton therapy (IMPT). IMPT plans of 13 patients treated before the implementation of the biologic dose constraint (cohort A) were compared with IMPT plans of 38 patients treated on MC1631 after its implementation (cohort B) using (1) a commercially available Eclipse treatment planning system (RBE = 1.1); (2) an in-house graphic processor unit-based Monte Carlo physical dose simulation (RBE = 1.1); and (3) an in-house Monte Carlo biologic dose (MCBD) simulation that assumes a linear relationship between RBE and dose-averaged linear energy transfer (product of RBE and physical dose = biologic dose).
RESULTS


Before implementation of a BP biologic dose constraint, the Eclipse mean BP D0.01 cm 3  was 107%, and the MCBD estimate was 128% (ie, 64 Gy [RBE = biologic dose] in 25 fractions for a 50-Gy [RBE = 1.1] prescription), compared with 100.0% and 116.0%, respectively, after the implementation of the constraint. Implementation of the BP biologic dose constraint did not significantly affect clinical target volume coverage. MCBD plans predicted greater internal mammary node coverage and higher heart dose than Eclipse plans.
CONCLUSIONS


Institution of a BP biologic dose constraint may reduce brachial plexopathy risk without compromising target coverage. MCBD plan evaluation provides valuable information to physicians that may assist in making clinical judgments regarding relative priority of target coverage versus normal tissue sparing.",2020,"MCBD plans predicted greater IMN coverage and higher heart dose than Eclipse plans.
",['13 patients treated prior to the implementation of the biologic dose constraint (cohort A) were compared with IMPT plans of 38 patients treated on'],"['breast cancer proton beam therapy', 'house graphic processor unit-based Monte Carlo physical dose simulation (RBE=1.1) and 3) in-house Monte Carlo biological dose (MCBD) simulation', 'XXXX', 'conventional vs hypofractionated postmastectomy intensity modulated proton therapy (IMPT']","['MCBD estimate', 'relative biological effectiveness (RBE) rises', 'brachial plexopathy risk', 'IMN coverage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445462', 'cui_str': 'Carlos (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0035023', 'cui_str': 'Effectiveness, Biologic Relative'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0700251', 'cui_str': 'Brachial Plexopathy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0364821,"MCBD plans predicted greater IMN coverage and higher heart dose than Eclipse plans.
","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota. Electronic address: mutter.robert@mayo.edu.'}, {'ForeName': 'Krishan R', 'Initials': 'KR', 'LastName': 'Jethwa', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hok Seum', 'Initials': 'HS', 'LastName': 'Wan Chan Tseung', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wick', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mohamed M H', 'Initials': 'MMH', 'LastName': 'Kahila', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jason K', 'Initials': 'JK', 'LastName': 'Viehman', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Shumway', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Corbin', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Remmes', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Whitaker', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Beltran', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}]",Practical radiation oncology,['10.1016/j.prro.2019.08.011']
781,30959470,Advance Care Planning Improves Psychological Symptoms But Not Quality of Life and Preferred End-of-Life Care of Patients With Cancer.,"BACKGROUND


This study was conducted to examine whether a longitudinal advance care planning (ACP) intervention facilitates concordance between the preferred and received life-sustaining treatments (LSTs) of terminally ill patients with cancer and improves quality of life (QoL), anxiety symptoms, and depressive symptoms during the dying process.
PATIENTS AND METHODS


Of 795 terminally ill patients with cancer from a medical center in Taiwan, 460 were recruited and randomly assigned 1:1 to the experimental and control arms. The experimental arm received an interactive ACP intervention tailored to participants' readiness to engage in this process. The control arm received symptom management education. Group allocation was concealed, data collectors were blinded, and treatment fidelity was monitored. Outcome measures included 6 preferred and received LSTs, QoL, anxiety symptoms, and depressive symptoms. Intervention effectiveness was evaluated by intention-to-treat analysis.
RESULTS


Participants providing data had died through December 2017. The 2 study arms did not differ significantly in concordance between the 6 preferred and received LSTs examined (odds ratios, 0.966 [95% CI, 0.653-1.428] and 1.107 [95% CI, 0.690-1.775]). Participants who received the ACP intervention had significantly fewer anxiety symptoms (β, -0.583; 95% CI, -0.977 to -0.189; P= .004) and depressive symptoms (β, -0.533; 95% CI, -1.036 to -0.030; P= .038) compared with those in the control arm, but QoL did not differ.
CONCLUSIONS


Our ACP intervention facilitated participants' psychological adjustment to the end-of-life (EoL) care decision-making process, but neither improved QoL nor facilitated EoL care honoring their wishes. The inability of our intervention to improve concordance may have been due to the family power to override patients' wishes in deeply Confucian doctrine-influenced societies such as Taiwan. Nevertheless, our findings reassure healthcare professionals that such an ACP intervention does not harm but improves the psychological well-being of terminally ill patients with cancer, thereby encouraging physicians to discuss EoL care preferences with patients and involve family caregivers in EoL care decision-making to eventually lead to patient value-concordant EoL cancer care.",2019,"Participants who received the ACP intervention had significantly fewer anxiety symptoms (β, -0.583; 95% CI, -0.977 to -0.189; P= .004) and depressive symptoms (β, -0.533; 95% CI, -1.036 to -0.030; P= .038) compared with those in the control arm, but QoL did not differ.
","['Of 795 terminally ill patients with cancer from a medical center in Taiwan, 460', 'terminally ill patients with cancer', 'Patients With Cancer']","['ACP intervention', 'longitudinal advance care planning (ACP) intervention', 'symptom management education', 'interactive ACP intervention', 'life-sustaining treatments (LSTs', 'Advance Care Planning']","['6 preferred and received LSTs, QoL, anxiety symptoms, and depressive symptoms', 'depressive symptoms', 'Intervention effectiveness', 'quality of life (QoL), anxiety symptoms, and depressive symptoms', 'Psychological Symptoms', 'anxiety symptoms']","[{'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",460.0,0.0690705,"Participants who received the ACP intervention had significantly fewer anxiety symptoms (β, -0.583; 95% CI, -0.977 to -0.189; P= .004) and depressive symptoms (β, -0.533; 95% CI, -1.036 to -0.030; P= .038) compared with those in the control arm, but QoL did not differ.
","[{'ForeName': 'Siew Tzuh', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, Medical College, Chang Gung University.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital; and.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, and.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital; and.'}, {'ForeName': 'John Wen-Cheng', 'Initials': 'JW', 'LastName': 'Chang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital; and.'}, {'ForeName': 'Chia-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital; and.'}, {'ForeName': 'Chen Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, National Taipei University of Nursing and Health Science, Taipei, Taiwan.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7106']
782,31033434,Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT.,"BACKGROUND


Children with juvenile idiopathic arthritis (JIA) are at risk of uveitis. The role of adalimumab (Humira ® ; AbbVie Inc., Ludwigshafen, Germany) in the management of uveitis in children needs to be determined.
OBJECTIVE


To compare the efficacy, safety and cost-effectiveness of adalimumab in combination with methotrexate (MTX) versus placebo with MTX alone, with regard to controlling disease activity in refractory uveitis associated with JIA.
DESIGN


This was a randomised (applying a ratio of 2 : 1 in favour of adalimumab), double-blind, placebo-controlled, multicentre parallel-group trial with an integrated economic evaluation. A central web-based system used computer-generated tables to allocate treatments. A cost-utility analysis based on visual acuity was conducted and a 10-year extrapolation by Markov modelling was also carried out.
SETTING


The setting was tertiary care centres throughout the UK.
PARTICIPANTS


Patients aged 2-18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks).
INTERVENTIONS


All participants received a stable dose of MTX and either adalimumab (20 mg/0.8 ml for patients weighing < 30 kg or 40 mg/0.8 ml for patients weighing ≥ 30 kg by subcutaneous injection every 2 weeks based on body weight) or a placebo (0.8 ml as appropriate according to body weight by subcutaneous injection every 2 weeks) for up to 18 months. A follow-up appointment was arranged at 6 months.
MAIN OUTCOME MEASURES


Primary outcome - time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria]. Economic outcome - incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the NHS in England and Personal Social Services providers. Full details of secondary outcomes are provided in the study protocol.
RESULTS


A total of 90 participants were randomised (adalimumab,  n  = 60; placebo,  n  = 30). There were 14 (23%) treatment failures in the adalimumab group and 17 (57%) in the placebo group. The analysis of the data from the double-blind phase of the trial showed that the hazard risk (HR) of treatment failure was significantly reduced, by 75%, for participants in the adalimumab group (HR 0.25, 95% confidence interval 0.12 to 0.51;  p  < 0.0001 from log-rank test). The cost-effectiveness of adalimumab plus MTX was £129,025 per QALY gained. Adalimumab-treated participants had a much higher incidence of adverse and serious adverse events.
CONCLUSIONS


Adalimumab in combination with MTX is safe and effective in the management of JIA-associated uveitis. However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
FUTURE WORK


A clinical trial is required to define the most effective time to stop therapy. Prognostic biomarkers of early and complete response should also be identified.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN10065623 and European Clinical Trials Database number 2010-021141-41.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 15. See the NIHR Journals Library website for further project information. This trial was also funded by Arthritis Research UK (grant reference number 19612). Two strengths of adalimumab (20 mg/0.8 ml and 40 mg/0.8 ml) and a matching placebo were manufactured by AbbVie Inc. (the Marketing Authorisation holder) and supplied in bulk to the contracted distributor (Sharp Clinical Services, Crickhowell, UK) for distribution to trial centres.",2019,"However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
","['refractory uveitis associated with juvenile idiopathic arthritis', 'refractory uveitis associated with JIA', 'Children with juvenile idiopathic arthritis (JIA', 'Patients aged 2-18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks', 'A total of 90 participants were randomised']","['methotrexate', 'methotrexate (MTX', 'placebo', 'placebo with MTX', 'adalimumab', 'Adalimumab', 'adalimumab,  n \u2009=\u200960; placebo', 'adalimumab plus MTX', 'MTX', 'adalimumab (Humira ® ; AbbVie Inc., Ludwigshafen, Germany']","[' time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria', 'adverse and serious adverse events', 'hazard risk (HR) of treatment failure', 'Economic outcome - incremental cost per quality-adjusted life-year (QALY', 'cost-effectiveness', 'efficacy, safety and cost-effectiveness']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3495559', 'cui_str': 'Arthritis, Juvenile Chronic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1171255', 'cui_str': 'Humira'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.518771,"However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
","[{'ForeName': 'Athimalaipet V', 'Initials': 'AV', 'LastName': 'Ramanan', 'Affiliation': 'Department of Paediatric Rheumatology, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Dick', 'Affiliation': 'Bristol Eye Hospital, Bristol, UK.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKay', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hardwick', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Culeddu', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Eifiona', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Compeyrot-Lacassagne', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Woo', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Edelsten', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beresford', 'Affiliation': ""Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23150']
783,31033232,Effect of Group-Based Outpatient Physical Therapy on Function After Total Knee Replacement: Results From a Multicenter Randomized Controlled Trial.,"OBJECTIVE


To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR).
METHODS


In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively.
RESULTS


The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported.
CONCLUSION


Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.",2020,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","['function after total knee replacement', '180 patients on a waiting list for primary TKR due to osteoarthritis']","['6 session group-based outpatient physiotherapy intervention and usual care (n=89) or usual care alone', 'novel group-based outpatient physiotherapy following total knee replacement (TKR', 'group-based outpatient physiotherapy']","['knee symptoms, depression, anxiety and satisfaction', 'patient satisfaction', 'patient-reported functional ability measured by the Lower Extremity Functional Scale']","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale (assessment scale)'}]",180.0,0.145058,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lenguerrand', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Artz', 'Affiliation': 'University of West of England, Bristol, UK.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Marques', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tarique', 'Initials': 'T', 'LastName': 'Parwez', 'Affiliation': 'Luton and Dunstable Hospital, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Beswick', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Burston', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'University of Bristol, Southmead Hospital, North Bristol NHS Trust, and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",Arthritis care & research,['10.1002/acr.23909']
784,30864054,Predictors of Smoking Cessation Among College Students in a Pragmatic Randomized Controlled Trial.,"An effective strategy to quit smoking should consider demographic aspects, smoking-related characteristics and psychological factors. This study examined potential predictors of smoking cessation in Spanish college students. A total of 255 college student smokers (18-24 years old), recruited to a cessation trial (Spain, 2013-2014), comprised an observational cohort. The main outcome was biochemically verified (urine cotinine) abstinence at the 6-month follow-up. Baseline potential predictors included socio-demographic, smoking-related and psychological variables (Fagerström Test for Nicotine Dependence (FTND), expired monoxide level (CO), intention to quit, previous quit attempts, participation in previous multicomponent programmes and confidence in quitting). Logistic regression models were used to identify potential predictors, the area under the ROC curve (AUC) was used to discriminate the capacity of the predictors and the Hosmer-Lemeshow goodness-of-fit test was used to assess model calibration. After 6 months of follow-up, variables related to high nicotine dependence, FTND and expired CO levels were associated with lower odds of quitting smoking (OR = 0.69 [95% CI 0.54-0.89] and 0.84 [0.77-0.92], respectively). Furthermore, being prepared to change (OR = 3.98 [1.49-10.64], p = 0.006) and being confident to quit (OR = 4.73 [2.12-10.55], p < 0.001) were also potential predictors of smoking cessation. The model that combined all these variables had the best predictive validity (AUC = 0.84 [0.78-0.91], p = 0.693) and showed good predictive capacity (χ 2  = 10.36, p = 0.241). Findings highlight that, in this population of college student smokers, having a lower level of nicotine dependence, being prepared to quit and having the confidence in the ability to quit were associated with smoking cessation, and these factors had good predictive capacity.",2019,"Furthermore, being prepared to change (OR = 3.98 [1.49-10.64], p = 0.006) and being confident to quit (OR = 4.73 [2.12-10.55], p < 0.001) were also potential predictors of smoking cessation.","['College Students', 'Spanish college students', '255 college student smokers (18-24\xa0years old), recruited to a cessation trial (Spain, 2013-2014']",[],"['good predictive capacity', 'biochemically verified (urine cotinine) abstinence', 'socio-demographic, smoking-related and psychological variables (Fagerström Test for Nicotine Dependence (FTND), expired monoxide level (CO), intention to quit, previous quit attempts, participation in previous multicomponent programmes and confidence in quitting', 'nicotine dependence, FTND and expired CO levels', 'Smoking Cessation', 'quitting smoking']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",255.0,0.0278709,"Furthermore, being prepared to change (OR = 3.98 [1.49-10.64], p = 0.006) and being confident to quit (OR = 4.73 [2.12-10.55], p < 0.001) were also potential predictors of smoking cessation.","[{'ForeName': 'Miren I', 'Initials': 'MI', 'LastName': 'Pardavila-Belio', 'Affiliation': 'Department of Community Nursing and Maternal & Child Health Care, University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Institute for Health Research (IdiSNA), Pamplona, Spain. mcanela@unav.es.'}, {'ForeName': 'Navidad', 'Initials': 'N', 'LastName': 'Canga-Armayor', 'Affiliation': 'Department of Community Nursing and Maternal & Child Health Care, University of Navarra, Pamplona, Navarra, Spain.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01004-6']
785,32152488,Blinded randomized crossover trial: Skin-to-skin care vs. sucrose for preterm neonatal pain.,"OBJECTIVE


To compare skin-to-skin care (SSC) and oral sucrose for preterm neonatal pain control.
METHODS


Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible. In group-A, SSC was given 15-min before first heel-stick, and sucrose was given 2-min before second heel-stick. In group-B, the sequence was reversed. Blinded premature infant pain profile (PIPP) score assessment was done at 0, 1, and 5-min of heel-stick by two assessors.
RESULTS


A hundred neonates were enrolled. The inter-rater agreement for the PIPP score was good. The behavior state component was significantly lower in the sucrose group at all assessment points. The mean (SD) difference between 1-min and 0 min was similar [SSC 3.58(3.16) vs. sucrose 4.09(3.82), p = 0.24] between groups. The PIPP score attained baseline values at 5-min in both groups.
CONCLUSION


Albeit sucrose indicated instantaneous action, SSC and sucrose have comparable clinical efficacy for preterm neonatal pain control. Multisensory stimulation with SSC may result in a higher behavioral state component of the PIPP score.",2020,The behavior state component was significantly lower in the sucrose group at all assessment points.,"['preterm neonatal pain control', 'Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible', 'preterm neonatal pain', 'A hundred neonates were enrolled']","['SSC', 'skin-to-skin care (SSC) and oral sucrose', 'Skin-to-skin care vs. sucrose']","['PIPP score', 'PIPP score attained baseline values', 'Blinded premature infant pain profile (PIPP) score assessment', 'behavior state component', 'mean (SD) difference']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0419343', 'cui_str': 'Heel stick (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.154339,The behavior state component was significantly lower in the sucrose group at all assessment points.,"[{'ForeName': 'Somashekhar', 'Initials': 'S', 'LastName': 'Nimbalkar', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Shukla', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India. viveks3985@gmail.com.'}, {'ForeName': 'Vishwa', 'Initials': 'V', 'LastName': 'Chauhan', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Phatak', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Chapla', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Nimbalkar', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0638-9']
786,31804680,Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial.,"Importance


Malignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations.
Objective


To test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.
Design, Setting, and Participants


Open-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung.
Interventions


Patients randomized to the talc poudrage group (n = 166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n = 164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.
Main Outcomes and Measures


The primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.
Results


Among 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes.
Conclusions and Relevance


Among patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences.
Trial Registration


ISRCTN Identifier: ISRCTN47845793.",2019,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","['Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia', 'Patients With Malignant Pleural Effusions', '330 patients who were randomized (mean age, 68 years', 'patients with malignant pleural effusion, thoracoscopic talc poudrage', 'Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung', '330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018']","['Talc pleurodesis', 'talc poudrage group (n\u2009=\u2009166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation', 'Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube', 'talc poudrage', 'bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry']","['Pleurodesis Failure Rate', 'pleurodesis failure rate', 'rate of pleurodesis failure', 'pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life', 'pleurodesis failure', 'cause mortality; and percentage of opacification on chest radiograph at drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0405997', 'cui_str': 'Talc pleurodesis (procedure)'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449584', 'cui_str': 'Opacification (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",330.0,0.381216,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatnagar', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Hania E G', 'Initials': 'HEG', 'LastName': 'Piotrowska', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Justin C T', 'Initials': 'JCT', 'LastName': 'Pepperell', 'Affiliation': 'Somerset Lung Centre, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Evison', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Holme', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Aloul', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Lungs for Living Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine, Nottingham University Hospitals NHS Trust, United Kingdom.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Glasgow Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Cox', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Downer', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Herre', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Pasupathy', 'Initials': 'P', 'LastName': 'Sivasothy', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Glan Clwyd Hospital, North Wales, United Kingdom.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Munavvar', 'Affiliation': 'Lancashire Teaching Hospitals NHS, Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Moe M', 'Initials': 'MM', 'LastName': 'Kyi', 'Affiliation': 'Respiratory Department, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, United Kingdom.'}, {'ForeName': 'Liju', 'Initials': 'L', 'LastName': 'Ahmed', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Alex G', 'Initials': 'AG', 'LastName': 'West', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Hettiarachchi', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, United Kingdom.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Chakrabarti', 'Affiliation': 'Aintree University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Ajikumar', 'Initials': 'A', 'LastName': 'Kavidasan', 'Affiliation': 'Milton Keynes University Hospital, Milton Keynes, United Kingdom.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Zahan-Evans', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Quaddy', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Edey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Amelia O', 'Initials': 'AO', 'LastName': 'Clive', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Matthew H R', 'Initials': 'MHR', 'LastName': 'Little', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Xue W', 'Initials': 'XW', 'LastName': 'Mei', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Hooper', 'Affiliation': 'Worcester Acute Hospitals NHS Trust, Worcester, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Davies', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slade', 'Affiliation': 'Department of Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Sivier', 'Affiliation': ''}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}]",JAMA,['10.1001/jama.2019.19997']
787,31237126,"Additional Effect of Dietary Fiber in Patients with Type 2 Diabetes Mellitus Using Metformin and Sulfonylurea: An Open-Label, Pilot Trial.","BACKGROUND


Metformin, sulfonylurea, and dietary fiber are known to affect gut microbiota in patients with type 2 diabetes mellitus (T2DM). This open and single-arm pilot trial investigated the effects of the additional use of fiber on glycemic parameters, insulin, incretins, and microbiota in patients with T2DM who had been treated with metformin and sulfonylurea.
METHODS


Participants took fiber for 4 weeks and stopped for the next 4 weeks. Glycemic parameters, insulin, incretins during mixed-meal tolerance test (MMTT), lipopolysaccharide (LPS) level, and fecal microbiota were analyzed at weeks 0, 4, and 8. The first tertile of difference in glucose area under the curve during MMTT between weeks 0 and 4 was defined as 'responders' and the third as 'nonresponders,' respectively.
RESULTS


In all 10 participants, the peak incretin levels during MMTT were higher and LPS were lower at week 4 as compared with at baseline. While the insulin sensitivity of the 'responders' increased at week 4, that of the 'nonresponders' showed opposite results. However, the results were not statistically significant. In all participants, metabolically unfavorable microbiota decreased at week 4 and were restored at week 8. At baseline, metabolically hostile bacteria were more abundant in the 'nonresponders.' In 'responders,'  Roseburia intestinalis  increased at week 4.
CONCLUSION


While dietary fiber did not induce additional changes in glycemic parameters, it showed a trend of improvement in insulin sensitivity in 'responders.' Even if patients are already receiving diabetes treatment, the additional administration of fiber can lead to additional benefits in the treatment of diabetes.",2019,"While the insulin sensitivity of the 'responders' increased at week 4, that of the 'nonresponders' showed opposite results.","['Participants took fiber for 4 weeks and stopped for the next 4 weeks', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM who had been treated with metformin and sulfonylurea', 'Patients with Type 2 Diabetes']","['Metformin and Sulfonylurea', 'Metformin, sulfonylurea, and dietary fiber', 'Dietary Fiber']","['insulin sensitivity', '  Roseburia intestinalis', 'metabolically hostile bacteria', 'Glycemic parameters, insulin, incretins during mixed-meal tolerance test (MMTT), lipopolysaccharide (LPS) level, and fecal microbiota', 'metabolically unfavorable microbiota', 'peak incretin levels', 'glycemic parameters']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3652453', 'cui_str': 'metformin and sulfonylureas'}]","[{'cui': 'C3652453', 'cui_str': 'metformin and sulfonylureas'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1196244', 'cui_str': 'Roseburia intestinalis (organism)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",10.0,0.0286291,"While the insulin sensitivity of the 'responders' increased at week 4, that of the 'nonresponders' showed opposite results.","[{'ForeName': 'Seung Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Environmental Health Sciences, Graduate School of Public Health, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Jun', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'You Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Man', 'Initials': 'SM', 'LastName': 'Jin', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu Yeon', 'Initials': 'KY', 'LastName': 'Hur', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gwang Pyo', 'Initials': 'GP', 'LastName': 'Ko', 'Affiliation': 'Department of Environmental Health Sciences, Graduate School of Public Health, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Moon Kyu', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. leemk@skku.edu.'}]",Diabetes & metabolism journal,['10.4093/dmj.2018.0090']
788,30629121,Cost-Effectiveness of a Therapeutic Tai Ji Quan Fall Prevention Intervention for Older Adults at High Risk of Falling.,"BACKGROUND


Data on the cost-effectiveness of proven fall prevention exercise interventions are limited. We aimed to establish the cost-effectiveness of Tai Ji Quan: Moving for Better Balance (TJQMBB) compared with a conventional exercise intervention for older adults at high risk of falling.
METHODS


We conducted a trial-based cost-effectiveness analysis involving 670 older adults who had a history of falling or impaired mobility. Participants received one of three interventions-TJQMBB, multimodal exercise, or stretching exercise (control)-each of which was implemented twice weekly for 24 weeks. The primary cost-effectiveness measure was the incremental cost per additional fall prevented, comparing TJQMBB and multimodal exercise to Stretching and TJQMBB to multimodal exercise, with a secondary measure of incremental cost per additional quality-adjusted life-year (QALY) gained. The intervention was conducted between February 2015 and January 2018, and cost-effectiveness was estimated from a health care system perspective over a 6-month time horizon.
RESULTS


The total cost to deliver the TJQMBB intervention was $202,949 (an average of $906 per participant); for multimodal exercise, it was $223,849 ($1,004 per participant); and for Stretching, it was $210,468 ($903 per participant). Incremental cost-effectiveness ratios showed that the multimodal exercise was cost-effective ($850 per additional fall prevented; $27,614 per additional QALY gained) relative to Stretching; however, TJQMBB was the most economically dominant strategy (ie, having lower cost and being clinically more efficacious) compared with multimodal and stretching exercises with regard to cost per additional fall prevented and per additional QALY gained. TJQMBB had a 100% probability of being cost-effective, relative to Stretching, at a threshold of $500 per each additional fall prevented and $10,000 per additional QALY gained. Sensitivity analyses showed the robustness of the results when extreme cases, medical costs only, and missing data were considered.
CONCLUSIONS


Among community-dwelling older adults at high risk for falls, TJQMBB is a cost-effective means of reducing falls compared with conventional exercise approaches.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02287740).",2019,"Conclusions


Among community-dwelling older adults at high risk for falls, TJQMBB is a cost-effective means of reducing falls compared to conventional exercise approaches.","['670 older adults who had a history of falling or impaired mobility', 'community-dwelling older adults', 'older adults at high risk of falling']","['interventions-TJQMBB, Multimodal Exercise, or Stretching Exercise (control)-each of which was implemented twice weekly for 24 weeks', 'therapeutic Tai Ji Quan fall prevention intervention', 'conventional exercise intervention', 'Tai Ji Quan: Moving for Better Balance (TJQMBB', 'Multimodal Exercise', 'TJQMBB']","['total cost to deliver the TJQMBB intervention', 'Incremental cost-effectiveness ratios', 'Cost-effectiveness', 'incremental cost per additional quality-adjusted life-year (QALY) gained', 'cost-effective']","[{'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0518456', 'cui_str': 'Physical mobility impairment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",670.0,0.0307647,"Conclusions


Among community-dwelling older adults at high risk for falls, TJQMBB is a cost-effective means of reducing falls compared to conventional exercise approaches.","[{'ForeName': 'Fuzhong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Oregon Research Institute, Eugene.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Harmer', 'Affiliation': 'Department of Exercise and Health Science, Willamette University, Salem, Oregon.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eckstrom', 'Affiliation': 'Division of General Internal Medicine & Geriatrics, Oregon Health and Science University, Portland.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Fitzgerald', 'Affiliation': 'Oregon Medical Group, Eugene.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Akers', 'Affiliation': 'Oregon Research Institute, Eugene.'}, {'ForeName': 'Li-Shan', 'Initials': 'LS', 'LastName': 'Chou', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Department of Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Voit', 'Affiliation': 'Voit Better Balance, Mercer Island, Washington.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Winters-Stone', 'Affiliation': 'Knight Cancer Institute and School of Nursing, Oregon Health and Science University, Portland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz008']
789,30820005,Fibroblast Growth Factor 23 Trajectories in Chronic Hemodialysis Patients: Lessons from the HEMO Study.,"BACKGROUND


Long-term patterns of fibroblast growth factor 23 (FGF23) are poorly characterized among dialysis patients.
OBJECTIVES


To identify different FGF23 trajectories and determine clinical factors that predict distinct FGF23 trajectories and whether FGF23 trajectories differ in regard to their associations with all-cause mortality among prevalent hemodialysis patients.
METHODS


The HEMO study was a randomized multicenter study evaluating the effects of high-dose vs. standard-dose and high-flux vs. low-flux hemodialysis on mortality. We measured intact FGF23 levels in stored serum samples at baseline and annually among 919 HEMO participants and identified FGF23 trajectories using group-based modeling. Logistic regression determined predictors of trajectories. Cox regression models evaluated the association between trajectory and all-cause mortality.
RESULTS


We identified 5 distinct FGF23 trajectory groups during the initial 24 months: low stable, low increasing, elevated increasing, elevated decreasing, and elevated stable. In multivariable models, diabetes, high dose dialysis, no venous catheter, low serum calcium, phosphorus, and interleukin-6, no vitamin D analog use, and greater residual kidney function were associated with the low stable trajectory group compared to the elevated stable group. High flux dialysis, no venous catheter, and low serum phosphorus and 25-hydroxyvitamin D were associated with the elevated decreasing trajectory group compared to the elevated stable group. After full adjustment, the low stable trajectory group was associated with reduced mortality (hazard ratio [HR] 0.61; 95% CI -0.41-0.91) compared to the elevated stable trajectory group.
CONCLUSIONS


We identified 5 distinct FGF23 trajectories over 24 months among HEMO study participants including a decreasing trajectory. The low stable FGF23 trajectory was associated with a reduced HR of all-cause mortality.",2019,"After full adjustment, the low stable trajectory group was associated with reduced mortality (hazard ratio [HR] 0.61; 95% CI -0.41-0.91) compared to the elevated stable trajectory group.
","['prevalent hemodialysis patients', 'Chronic Hemodialysis Patients', 'dialysis patients']",['high-dose vs. standard-dose and high-flux vs. low-flux hemodialysis'],"['venous catheter, low serum calcium, phosphorus, and interleukin-6, no vitamin D analog use, and greater residual kidney function', 'reduced mortality', 'High flux dialysis, no venous catheter, and low serum phosphorus and 25-hydroxyvitamin D', 'mortality', 'intact FGF23 levels']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1520059', 'cui_str': 'Vitamin D analog (substance)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",919.0,0.0149779,"After full adjustment, the low stable trajectory group was associated with reduced mortality (hazard ratio [HR] 0.61; 95% CI -0.41-0.91) compared to the elevated stable trajectory group.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Renal Section, Medical Service, Veteran Affairs Eastern Colorado Health Care System, Denver, Colorado, USA, Anna.Jovanovich@ucdenver.edu.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine and Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nowak', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.'}]",American journal of nephrology,['10.1159/000497445']
790,30870668,"Poverty, economic strengthening, and mental health among AIDS orphaned children in Uganda: Mediation model in a randomized clinical trial.","Some evidence points to the positive effects of asset accumulation programs on mental health of children living in low-resource contexts. However, no evidence exists as to why and how such impact occurs. Our study aims to understand whether child poverty, child work, and household wealth serve as pathways through which the economic strengthening intervention affects the mental health of AIDS-orphaned children. The study employed a cluster-randomized experimental design with a family-based economic strengthening intervention conducted among 1410 school-going AIDS-orphaned children ages 10 and 16 years old in 48 primary schools in South Western Uganda. To test the hypothesized relationships between the intervention, mediators (household wealth, child poverty, and child's work) and mental health, we ran structural equation models that adjust for clustering of individuals within schools and account for potential correlation among the mediators. We found significant unmediated effect of the intervention on children's mental health at 24 months (B = -0.59; 95% CI: 0.93, -0.25; p < 0.001; β = -0.33). Furthermore, the results suggest that participation in the intervention reduced child poverty at 12 months, which in turn improved latent mental health outcome at 24 months (B = -0.14; 95% CI: -0.29, -0.01; p < 0.06; β = -0.08). In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation. Our findings suggest that anti-poverty programs that aim solely to improve household income may be less advantageous to children's mental health as compared to those that are specifically targeted towards reducing the impact of poverty on children. Further studies using more comprehensive measures of child work and age-appropriate child mental health may shed more light on understanding the link between asset accumulation interventions, child labor and children's mental health.",2019,"In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation.","['1410 school-going AIDS-orphaned children ages 10 and 16 years old in 48 primary schools in South Western Uganda', 'children living in low-resource contexts']",['family-based economic strengthening intervention'],"['child poverty', 'latent mental health outcome', 'Poverty, economic strengthening, and mental health', ""children's mental health"", 'mental health of children']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013557', 'cui_str': 'economics'}]",,0.0620438,"In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation.","[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Karimli', 'Affiliation': 'University of California, Los Angeles (UCLA), Luskin School of Public Affairs, Social Welfare Department, United States. Electronic address: leylakarimli@luskin.ucla.edu.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, George Warren Brown School of Social Work, United States. Electronic address: fms1@wustl.edu.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'University of California, School of Medicine, San Francisco, United States. Electronic address: Torsten.Neilands@ucsf.edu.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Wells', 'Affiliation': 'University of California, Los Angeles (UCLA), Statistical Consulting Group, United States. Electronic address: crwells@ucla.edu.'}, {'ForeName': 'Laura Gauer', 'Initials': 'LG', 'LastName': 'Bermudez', 'Affiliation': 'Columbia University, School of Social Work, United States. Electronic address: lgb2123@columbia.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.003']
791,30488229,Self-affirmation enhances the processing of uncertainty: An event-related potential study.,"We proposed that self-affirmation can endow people with more cognitive resource to cope with uncertainty. We tested this possibility with an event-related potential (ERP) study by examining how self-affirmation influences ambiguous feedback processing in a simple gambling task, which was used to investigate risk decision-making. We assigned 48 participants randomly to the affirmation and non-affirmation (i.e., control) groups. All participants accepted the manipulation first and then completed the gambling task with an electroencephalogram (EEG) recording, in which participants might receive a positive (winning), negative (losing), or ambiguous (unknown valence) outcome after they made a choice. We considered both the feedback-related negativity (FRN) and P3 components elicited by the outcome feedback, which reflected the amount of cognitive resources being invested in the early and late stages of the outcome feedback processing, respectively. ERP results showed that ambiguous feedback elicited a larger FRN among affirmed participants than unaffirmed participants but exerted no influence on the P3. This finding suggests that self-affirmation may help coping with uncertainty by enhancing the early processing of uncertainty.",2019,ERP results showed that ambiguous feedback elicited a larger FRN among affirmed participants than unaffirmed participants but exerted no influence on the P3.,"['48 participants randomly to the affirmation and non-affirmation (i.e., control) groups']",['gambling task with an electroencephalogram (EEG) recording'],['ambiguous feedback elicited a larger FRN'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C3539086', 'cui_str': 'Ambiguous component (foundation metadata concept)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",48.0,0.0317719,ERP results showed that ambiguous feedback elicited a larger FRN among affirmed participants than unaffirmed participants but exerted no influence on the P3.,"[{'ForeName': 'Ruolei', 'Initials': 'R', 'LastName': 'Gu', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'College of Tourism, Huaqiao University, Quanzhou, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China.'}, {'ForeName': 'Mingzheng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huajian', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China. caihj@psych.ac.cn.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-018-00673-0']
792,31390590,Screening and Stepped Care Targeting Psychological Distress in Patients With Metastatic Colorectal Cancer: The TES Cluster Randomized Trial.,"BACKGROUND


This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colorectal cancer starting with first-line systemic palliative treatment.
PATIENTS AND METHODS


In this cluster randomized trial, 16 hospitals were assigned to the TES program or CAU. Patients in the TES arm were screened for psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List (at baseline and 10 and 18 weeks). Stepped care was offered to patients with distress or expressed needs, and it consisted of watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare. The primary outcome was change in psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians. Linear mixed models and effect sizes were used to evaluate differences.
RESULTS


A total of 349 patients were randomized; 184 received the TES program and 165 received CAU. In the TES arm, 60.3% of the patients screened positive for psychological distress, 26.1% of which entered the stepped care program (14.7% used only watchful waiting and 11.4% used at least one of the other treatment steps). The observed low use of the TES program led us to pursue a futility analysis, which showed a small conditional power and therefore resulted in halted recruitment for this study. No difference was seen in change in psychological distress over time between the 2 groups (effect size, -0.16; 95% CI, -0.35 to 0.03; P>.05). The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
CONCLUSIONS


As a result of the low use of stepped care, a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer did not improve psychological distress. Our results suggest that enhanced evaluation of psychosocial concerns may improve aspects of patient well-being.",2019,"The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
","['Patients', 'With Metastatic Colorectal Cancer', '349 patients were randomized; 184 received the', 'patients with metastatic colorectal cancer starting with first-line systemic palliative treatment', '16 hospitals', 'patients with metastatic colorectal cancer']","['TES program and 165 received CAU', 'TES', 'care as usual (CAU', 'screening and stepped care program (the TES program', 'TES program or CAU', 'Screening and Stepped Care', 'watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare']","['psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List', 'psychological distress', 'psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians', 'cognitive quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",349.0,0.121005,"The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
","[{'ForeName': 'Claudia S E W', 'Initials': 'CSEW', 'LastName': 'Schuurhuizen', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Annemarie M J', 'Initials': 'AMJ', 'LastName': 'Braamse', 'Affiliation': 'Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Institute, Academic Medical Center, Amsterdam.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, VU University, Amsterdam.'}, {'ForeName': 'Mecheline H M', 'Initials': 'MHM', 'LastName': 'van der Linden', 'Affiliation': 'Department of Medical Psychology, and.'}, {'ForeName': 'Adriaan W', 'Initials': 'AW', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Berkhof', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Medical Oncology, Flevoziekenhuis, Almere.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Lustig', 'Affiliation': 'Department of Medical Oncology, Flevoziekenhuis, Almere.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Department of Medical Oncology, Noordwest Ziekenhuisgroep, Alkmaar.'}, {'ForeName': 'Haiko J', 'Initials': 'HJ', 'LastName': 'Bloemendal', 'Affiliation': 'Department of Medical Oncology, Meander Medical Center, Amersfoort.'}, {'ForeName': 'Cees J', 'Initials': 'CJ', 'LastName': 'van Groeningen', 'Affiliation': 'Department of Medical Oncology, Hospital Amstelland, Amstelveen.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Department of Medical Oncology, Hospital Amstelland, Amstelveen.'}, {'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Rijnstate Hospital, Arnhem.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Rietbroek', 'Affiliation': 'Department of Medical Oncology, Red Cross Hospital, Beverwijk.'}, {'ForeName': 'Cathrien S', 'Initials': 'CS', 'LastName': 'Tromp-van Driel', 'Affiliation': 'Department of Medical Oncology, Noordwest Ziekenhuisgroep, Den Helder.'}, {'ForeName': 'Machteld N W', 'Initials': 'MNW', 'LastName': 'Wymenga', 'Affiliation': 'Department of Medical Oncology, Medisch Spectrum Twente, Enschede.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'van der Linden', 'Affiliation': 'Department of Medical Oncology, Spaarne Gasthuis, Haarlem.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Medical Oncology, Spaarne Gasthuis, Hoofddorp.'}, {'ForeName': 'Marco B', 'Initials': 'MB', 'LastName': 'Polee', 'Affiliation': 'Department of Medical Oncology, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Batman', 'Affiliation': 'Department of Medical Oncology, Alrijne Hospital, Leiden.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Los', 'Affiliation': 'Department of Medical Oncology, St. Antonius Hospital, Nieuwegein.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'van Bochove', 'Affiliation': 'Department of Medical Oncology, Zaans Medical Center, Zaandam; and.'}, {'ForeName': 'Jan A C', 'Initials': 'JAC', 'LastName': 'Brakenhoff', 'Affiliation': 'Department of Medical Oncology, Waterland Hospital, Purmerend, the Netherlands.'}, {'ForeName': 'Inge R H M', 'Initials': 'IRHM', 'LastName': 'Konings', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7285']
793,30659257,The influence of 15-week exercise training on dietary patterns among young adults.,"BACKGROUND/OBJECTIVES


Little is currently known about how exercise may influence dietary patterns and/or food preferences. The present study aimed to examine the effect of a 15-week exercise training program on overall dietary patterns among young adults.
SUBJECTS/METHODS


This study consisted of 2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study. Subjects underwent 15 weeks of aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors. In total, 4355 dietary observations with 102 food items were collected using a self-administered food frequency questionnaire before and after exercise training (n = 2476 at baseline; n = 1859 at 15 weeks). Dietary patterns were identified using a Bayesian sparse latent factor model. Changes in dietary pattern preferences were evaluated based on the pre/post-training differences in dietary pattern scores, accounting for the effects of gender, race/ethnicity, and BMI.
RESULTS


Within each of the seven dietary patterns identified, most dietary pattern scores were decreased following exercise training, consistent with increased voluntary regulation of food intake. A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β: -0.1280; 95% credible interval: -0.1877, -0.0637) patterns, while a higher intensity of exercise was linked to an increased preference for the prudent pattern (β: 0.0623; 95% credible interval: 0.0159, 0.1111). Consequently, a higher dose of exercise was related to a decreased preference for the snacking pattern (β: -0.0023; 95% credible interval: -0.0042, -0.0004) and an increased preference for the prudent pattern (β: 0.0029; 95% credible interval: 0.0009, 0.0048).
CONCLUSIONS


The 15-week exercise training appeared to motivate young adults to pursue healthier dietary preferences and to regulate their food intake.",2019,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","['2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study', 'young adults']","['15-week exercise training program', 'aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors', '15-week exercise training']","['voluntary regulation of food intake', 'dietary pattern preferences', 'overall dietary patterns', 'dietary pattern scores']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4355.0,0.0292461,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","[{'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sinead A', 'Initials': 'SA', 'LastName': 'Williamson', 'Affiliation': 'Departments of Information, Risk, & Operations Management and Statistics & Data Science, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Vazquez', 'Affiliation': 'Department of Epidemiology & Biostatistics and Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Bray', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA. mbray@austin.utexas.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0299-3']
794,31393176,Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.,"Background:  The  G lycemia  R eduction  A pproaches in  D iabetes: A Comparative  E ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  Methods:  The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations.  Conclusions:  The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.",2019,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","['Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other', 'patients of different races or ethnicities', 'enrolled a racially and ethnically diverse population with type 2 diabetes', '1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared']",['CGM'],"['R eduction', 'average glucose (AG) and hemoglobin A1c (HbA1c']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",450.0,0.0248676,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higgins', 'Affiliation': 'Department of Systems Biology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tiktin', 'Affiliation': 'Multidisciplinary Research, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Cincinnati VA Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arends', 'Affiliation': 'Advanced Research and Diagnostic Laboratory, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0202']
795,30916641,Sexual risk reduction interventions for patients attending sexual health clinics: a mixed-methods feasibility study.,"BACKGROUND


Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England.
OBJECTIVES


The study (Santé) had two main objectives - (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care.
DESIGN


The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen.
SETTING


SH clinics in England.
PARTICIPANTS


Young people (aged 16-25 years), and men who have sex with men.
INTERVENTION


A three-part intervention package - (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients.
MAIN OUTCOME MEASURES


The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial).
RESULTS


We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%).
LIMITATIONS


Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT.
CONCLUSION


We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN16738765.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 12. See the NIHR Journals Library website for further project information.",2019,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"['Young people (aged 16-25 years), and men who have sex with men', 'patients attending sexual health clinics', 'SH clinics in England', 'patients attending sexual health (SH) services', 'recruited patients from six clinics for the follow-up, rather than eight']","['brief one-to-one session based on motivational interviewing', 'Sexual risk reduction interventions']","['STI rates', 'risky sexual behaviours', 'completion rate']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0603458,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Burns', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Howarth', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Sexually Transmitted Infection Surveillance, Public Health England, London, UK.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Miners', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollard', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23120']
796,31141104,P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes.,"Importance


Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown.
Objective


To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial.
Design, Setting, and Participants


The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019.
Interventions


Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization.
Main Outcomes and Measures


Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected.
Results


Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated.
Conclusions and Relevance


Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach.
Clinical Trial Registration


ClinicalTrials.gov identifier: NCT02293395.",2019,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","['371 clinical centers in 21 countries and 3037 patients with ACS', 'patients with recent acute coronary syndromes (ACS', '3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with', '48 patients (3.6%) with reduced metabolizer status treated initially with', 'Acute Coronary Syndrome']","['CYP2C19 Clopidogrel Metabolizer', 'rivaroxaban', 'ticagrelor', 'Clopidogrel or Ticagrelor', 'aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor', 'Rivaroxaban vs Aspirin', 'clopidogrel']",['Measures\n\n\nReasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events'],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",3037.0,0.0356846,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar and Dutch Network for Cardiovascular Research, the Netherlands.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Insituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'DHU FIRE, Université Paris-Diderot, AP-HP and Inserm U-1148, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Faculty of Medicine, Internal Medicine III, Freiburg, Germany.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexei N', 'Initials': 'AN', 'LastName': 'Plotnikov', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'PERFUSE Study Group, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1510']
797,30727856,DEFUSE 3 Non-DAWN Patients.,"Background and Purpose- DAWN (Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) and DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) established thrombectomy for patients with emergent large vessel occlusions presenting 6 to 24 hours after symptom onset. Given the greater inclusivity of DEFUSE 3, we evaluated the effect of thrombectomy in DEFUSE 3 patients who would have been excluded from DAWN. Methods- Eligibility criteria of the DAWN trial were applied to DEFUSE 3 patient data to identify DEFUSE 3 patients not meeting DAWN criteria (DEFUSE 3 non-DAWN). Reasons for DAWN exclusion in DEFUSE 3 were infarct core too large, National Institutes of Health Stroke Scale (NIHSS) score 6 to 9, and modified Rankin Scale score of 2. Subgroups were compared with the DEFUSE 3 non-DAWN and entire DEFUSE 3 cohorts. Results- There were 71 DEFUSE 3 non-DAWN patients; 31 patients with NIHSS 6 to 9, 33 with core too large, and 13 with premorbid modified Rankin Scale score of 2 (some patients met multiple criteria). For core-too-large patients, median 24-hour infarct volume was 119 mL (interquartile range, 74.6-180) versus 31.5 mL (interquartile range, 17.6-64.3) for core-not-too-large patients ( P<0.001). Complications and functional outcomes were similar between the groups. Thrombectomy in core-too-large patients compared with the remaining DEFUSE 3 non-DAWN patients conveyed benefit for functional outcome (odds ratio, 20.9; CI, 1.3-337.8). Comparing the NIHSS 6 to 9 group with the NIHSS ≥10 patients, modified Rankin Scale score 0 to 2 outcomes were achieved in 74% versus 22% ( P<0.001), with mortality in 6% versus 23% ( P=0.024), respectively. For patients with NIHSS 6 to 9 compared with the remaining DEFUSE 3 non-DAWN patients, thrombectomy trended toward a better chance of functional outcome (odds ratio, 1.86; CI, 0.36-9.529). Conclusions- Patients with pretreatment core infarct volumes <70 mL but too large for inclusion by DAWN criteria demonstrate benefit from endovascular therapy. More permissive pretreatment core thresholds in core-clinical mismatch selection paradigms may be appropriate. In contrast to data supporting a beneficial treatment effect across the full range of NIHSS scores in the entire DEFUSE 3 population, only a trend toward benefit of thrombectomy in patients with NIHSS 6 to 9 was found in this small subgroup.",2019,Complications and functional outcomes were similar between the groups.,"['patients who would have been excluded from DAWN', 'patients with emergent large vessel occlusions presenting 6 to 24 hours after symptom onset']",[],"['mortality', 'median 24-hour infarct volume', 'chance of functional outcome', 'Complications and functional outcomes', 'modified Rankin Scale score', 'NIHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0482616,Complications and functional outcomes were similar between the groups.,"[{'ForeName': 'Thabele M', 'Initials': 'TM', 'LastName': 'Leslie-Mazwi', 'Affiliation': 'From the Neuroscience Institute, Massachusetts General Hospital, Boston (T.M.L.-M., A.B.P., L.H.S., J.A.H.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Palo Alto, CA (S.H., M. Mlynash, M.G.L., M. Marks, G.W.A.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Palo Alto, CA (S.H., M. Mlynash, M.G.L., M. Marks, G.W.A.).'}, {'ForeName': 'Aman B', 'Initials': 'AB', 'LastName': 'Patel', 'Affiliation': 'From the Neuroscience Institute, Massachusetts General Hospital, Boston (T.M.L.-M., A.B.P., L.H.S., J.A.H.).'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Schwamm', 'Affiliation': 'From the Neuroscience Institute, Massachusetts General Hospital, Boston (T.M.L.-M., A.B.P., L.H.S., J.A.H.).'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Palo Alto, CA (S.H., M. Mlynash, M.G.L., M. Marks, G.W.A.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Palo Alto, CA (S.H., M. Mlynash, M.G.L., M. Marks, G.W.A.).'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Hirsch', 'Affiliation': 'From the Neuroscience Institute, Massachusetts General Hospital, Boston (T.M.L.-M., A.B.P., L.H.S., J.A.H.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Palo Alto, CA (S.H., M. Mlynash, M.G.L., M. Marks, G.W.A.).'}]",Stroke,['10.1161/STROKEAHA.118.023310']
798,30562555,Declines in motor transfer following upper extremity task-specific training in older adults.,"BACKGROUND


Age-related declines in function can limit older adults' independence with activities of daily living (ADLs). While task-specific training maybe a viable approach to improve function, limited clinical resources prevent extensive training on wide ranges of skills and contexts. Thus, training on one task for the benefit of another (i.e., transfer) is important in geriatric physical rehabilitation. The purpose of this study was to test whether motor transfer would occur between two functionally different upper extremity tasks that simulate ADLs in a sample of older adults following task-specific training.
METHODS


Ninety community dwelling adults ages 43 to 94 years old performed two trials of a functional dexterity and functional reaching task at baseline, and were then assigned to one of two groups. The training group completed 3 days of task-specific training (150 trials) on the functional reaching task, whereas the no-training group received no training on either task. Both groups were re-tested on both tasks at the end of Day 3.
RESULTS


No significant interactions were observed between group (training vs. no-training) and time (baseline vs. re-test) on the functional dexterity task (i.e. transfer task), indicating no difference in the average amount of change from baseline to re-test between the groups. However, post hoc bivariate linear regression revealed an effect of age on motor transfer within the training group. For those who trained on the functional reaching task, the amount of transfer to the dexterity task was inversely related to age. There was no significant relationship between age and motor transfer for the no-training group.
DISCUSSION AND CONCLUSIONS


Results of our a priori group analysis suggest that functional reaching training did not, on average, transfer to the dexterity task. However, post hoc regression analysis showed that motor transfer was both experience- and age-dependent, such that motor transfer may decline with advanced age. Future research will consider how functional and cognitive aging influences transfer of motor skills across different activities of daily living.",2019,"For those who trained on the functional reaching task, the amount of transfer to the dexterity task was inversely related to age.","['Ninety community dwelling adults ages 43 to 94\u202fyears old performed two trials of a', 'older adults following task-specific training', 'older adults']","['functional dexterity and functional reaching task at baseline', 'training group completed 3\u202fdays of task-specific training (150 trials) on the functional reaching task, whereas the no-training group received no training on either task', 'upper extremity task-specific training']","['motor transfer', 'functional dexterity task']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}]",90.0,0.0131038,"For those who trained on the functional reaching task, the amount of transfer to the dexterity task was inversely related to age.","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Walter', 'Affiliation': 'Department of Physical Therapy, 1125 N. College Avenue, University of Arkansas for Medical Sciences, Fayetteville, AR 72703, USA.'}, {'ForeName': 'Caitlin R', 'Initials': 'CR', 'LastName': 'Hengge', 'Affiliation': 'University of Utah, 50 N. Medical Dr., Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Bergen E', 'Initials': 'BE', 'LastName': 'Lindauer', 'Affiliation': 'University of Utah, 50 N. Medical Dr., Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Sydney Y', 'Initials': 'SY', 'LastName': 'Schaefer', 'Affiliation': 'University of Utah, 50 N. Medical Dr., Salt Lake City, UT 84112, USA; School of Biological and Health Systems Engineering, 501 E. Tyler Mall, ECG 334A, Arizona State University, Tempe, AZ 85287, USA. Electronic address: sydney.schaefer@asu.edu.'}]",Experimental gerontology,['10.1016/j.exger.2018.12.012']
799,30677485,Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.,"Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood pressure and reduce the risks and medication burden they may face over a lifetime. To address the unmet need in hypertensive care for young adults, we developed MyHEART (My Hypertension Education And Reaching Target), a multi-component, theoretically-based intervention designed to achieve self-management among young adults with uncontrolled hypertension. MyHEART is a patient-centered program, based upon the Self-Determination Theory, that uses evidence-based health behavior approaches to lower blood pressure. Therefore, the objective of this study is to evaluate MyHEART's impact on changes in systolic and diastolic blood pressure compared to usual care after 6 and 12 months in 310 geographically and racially/ethnically diverse young adults with uncontrolled hypertension. Secondary outcomes include MyHEART's impact on behavioral outcomes at 6 and 12 months, compared to usual clinical care (increased physical activity, decreased sodium intake) and to examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes). MyHEART is one of the first multicenter, randomized controlled hypertension trials tailored to young adults with primary care. The design and methodology will maximize the generalizability of this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03158051.",2019,"MyHEART is a patient-centered program, based upon the Self-Determination Theory, that uses evidence-based health behavior approaches to lower blood pressure.","['young adults', 'middle-aged and older populations', 'young adults with uncontrolled hypertension', 'young adults with primary care', '310 geographically and racially/ethnically diverse young adults with uncontrolled hypertension', 'Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease']",[],"['behavioral outcomes at 6 and 12 months, compared to usual clinical care (increased physical activity, decreased sodium intake', 'self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes', 'systolic and diastolic blood pressure', 'hypertension control']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",310.0,0.0592856,"MyHEART is a patient-centered program, based upon the Self-Determination Theory, that uses evidence-based health behavior approaches to lower blood pressure.","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA. Electronic address: hm2@medicine.wisc.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sullivan-Vedder', 'Affiliation': 'Aurora Health Care Department of Family Medicine, Family Care Center, 1020 N 12(th) Street, Milwaukee, WI 53233, USA. Electronic address: Lisa.Vedder@aurora.org.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, K6/420 Clinical Sciences Center, 600 Highland Avenue, Madison, WI 53792-4675, USA. Electronic address: kyungmann.kim@wisc.edu.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'McBride', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA. Electronic address: pem@medicine.wisc.edu.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA; Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, 610 Walnut Street, 707 WARF Building, Madison, WI 53726, USA; Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI 53715-1896, USA. Electronic address: maureensmith@wisc.edu.'}, {'ForeName': 'Jamie N', 'Initials': 'JN', 'LastName': 'LaMantia', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA. Electronic address: jnlamantia@medicine.wisc.edu.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Fink', 'Affiliation': 'Department of Health Informatics and Administration, University of Wisconsin-Milwaukee College of Health Sciences, NWQ Building B, Suite #6455, 2025 E. Newport Avenue, Milwaukee, WI 53211-2906, USA. Electronic address: jtfink@uwm.edu.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Knutson Sinaise', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA. Electronic address: mknutson2@wisc.edu.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Zeller', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA. Electronic address: lmzeller@wisc.edu.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Lauver', 'Affiliation': 'School of Nursing, University of Wisconsin, Signe Skott Cooper Hall, 701 Highland Avenue, Madison, WI 53705, USA. Electronic address: drlauver@wisc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.010']
800,31076261,PCSK9 inhibition in patients with and without prior myocardial infarction or ischemic stroke: A pooled analysis of nine randomized-controlled studies of alirocumab.,"BACKGROUND


Patients with prior cardiovascular events are at very high risk of recurrent events and may benefit from low-density lipoprotein cholesterol (LDL-C) lowering beyond that achieved with maximally tolerated statins.
OBJECTIVE


To assess potential differences between the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in patients with vs without prior myocardial infarction (MI)/ischemic stroke.
METHODS


Data (n = 4880) were pooled from nine ODYSSEY phase 3 trials of alirocumab 75/150 mg or 150 mg every 2 weeks, mostly on background statins ± other lipid-lowering therapies. Analyses were performed according to statin status, alirocumab dose, and control (placebo or ezetimibe).
RESULTS


Baseline LDL-C, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B levels were lower and lipoprotein(a) higher in patients with than without prior MI/ischemic stroke. LDL-C levels were reduced from baseline to week 24 in patients with (51.1%-62.9%) and without (43.6%-58.3%) prior MI/ischemic stroke, with no significant interaction between prior MI/ischemic stroke status and LDL-C-lowering efficacy of alirocumab vs controls. Alirocumab significantly reduced other lipid/lipoproteins (including lipoprotein[a]) similarly in patients with/without MI/ischemic stroke. Week 24 LDL-C goal attainment rates for subgroups with/without prior MI/ischemic stroke on background statins were 74.1%-84.8% and 63.7%-74.7%, respectively. The safety profile of alirocumab was generally similar regardless of prior MI/ischemic stroke status.
CONCLUSIONS


Alirocumab significantly reduced LDL-C and other atherogenic lipids/lipoproteins in patients with prior MI/ischemic stroke, and the majority of this very high cardiovascular risk population achieved LDL-C goals; efficacy and safety results were similar in patients without prior MI/ischemic stroke.",2019,"LDL-C levels were reduced from baseline to week 24 in patients with (51.1%-62.9%) and without (43.6%-58.3%) prior MI/ischemic stroke, with no significant interaction between prior MI/ischemic stroke status and LDL-C-lowering efficacy of alirocumab vs controls.","['patients with/without MI/ischemic stroke', 'patients with and without prior myocardial infarction or ischemic stroke', 'patients with vs without prior myocardial infarction (MI)/ischemic stroke', 'Data (n\xa0=\xa04880', 'patients with prior MI/ischemic stroke', 'Patients with prior cardiovascular events']","['alirocumab', 'proprotein convertase subtilisin/kexin type 9 inhibitor, alirocumab', 'Alirocumab', 'PCSK9 inhibition', 'control (placebo or ezetimibe', 'alirocumab 75/150\xa0mg or 150\xa0mg every 2\xa0weeks, mostly on background statins\xa0±\xa0other lipid-lowering therapies']","['Baseline LDL-C, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B levels', 'lipid/lipoproteins (including lipoprotein[a', 'LDL-C levels', 'LDL-C and other atherogenic lipids/lipoproteins']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",4880.0,0.0870683,"LDL-C levels were reduced from baseline to week 24 in patients with (51.1%-62.9%) and without (43.6%-58.3%) prior MI/ischemic stroke, with no significant interaction between prior MI/ischemic stroke status and LDL-C-lowering efficacy of alirocumab vs controls.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': ""Groupe Hospitalier Pitié-Salpêtrière, Service d'Endocrinologie, Métabolisme et Prévention des Maladies Cardiovasculaires, Paris, France. Electronic address: eric.bruckert@aphp.fr.""}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital, Heart and Vascular Center/The Lindner Research Center, Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Biostatistics and Programming, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Biostatistics and Data Management, Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': 'Harvard Clinical Research Institute, Preventive Cardiology Section, Boston, MA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.04.005']
801,30630108,"iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children.","Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families that capitalizes on the innovative use of mobile health applications (mHealth). iAmHealthy is a 25-contact hour multicomponent intervention delivered over an 8-month period targeting 2nd-4th grade school children and their families. This paper describes the rationale, design, participant/school enrollment, and planned implementation of a randomized controlled trial of the iAmHealthy intervention in comparison to a monthly newsletter delivered through rural elementary schools. Child Body Mass Index z-score (BMIz) is the primary outcome, along with child 24-hour dietary recall, and child accelerometer-determined physical activity and sedentary behavior as secondary outcomes. The study will include 18 schools (with 8 children each) resulting in a final planned sample size of 144 children. This project also has a strong focus on dissemination and implementation science, and thus includes many measures related to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Data collection is completed at baseline, end of intervention (8 months), and follow-up (20 months). This study is the first randomized controlled trial to deliver a rurally tailored, empirically supported, family-based behavioral intervention for pediatric obesity solely over mHealth. Registered with ClinicalTrials.gov NCT ID 03304249.",2019,"This study is the first randomized controlled trial to deliver a rurally tailored, empirically supported, family-based behavioral intervention for pediatric obesity solely over mHealth.","['comparison to a monthly newsletter delivered through rural elementary schools', '18 schools (with 8 children each) resulting in a final planned sample size of 144 children', 'rural children']","['family-based behavioral intervention', 'family-based mHealth pediatric obesity intervention']",['Child Body Mass Index z-score (BMIz'],"[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",144.0,0.0874542,"This study is the first randomized controlled trial to deliver a rurally tailored, empirically supported, family-based behavioral intervention for pediatric obesity solely over mHealth.","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Davis', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, 610 E 22nd St, Kansas City, MO 64108, United States; Department of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS 66160, United States. Electronic address: Adavis6@kumc.edu.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Beaver', 'Affiliation': 'School of Medicine, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, United States.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Dreyer Gillette', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, 610 E 22nd St, Kansas City, MO 64108, United States; Department of Pediatrics, Developmental and Behavioral Sciences, Children's Mercy Kansas City, 2401 Gillham Rd., Kansas City, MO 64108, United States.""}, {'ForeName': 'Eve-Lynn', 'Initials': 'EL', 'LastName': 'Nelson', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, 610 E 22nd St, Kansas City, MO 64108, United States; Center for Telemedicine & Telehealth, University of Kansas Medical Center, Kansas City, KS 66160, United States.""}, {'ForeName': 'Kandace', 'Initials': 'K', 'LastName': 'Fleming', 'Affiliation': 'Lifespan Institute, University of Kansas, Lawrence, KS 66045, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Swinburne Romine', 'Affiliation': 'Lifespan Institute, University of Kansas, Lawrence, KS 66045, United States.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, 610 E 22nd St, Kansas City, MO 64108, United States; Department of Dietetics & Nutrition, University of Kansas Medical Center, Kansas City, KS 66160, United States.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Health Policy & Management, University of Kansas Medical Center, Kansas City, KS 66160, United States.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Pettee Gabriel', 'Affiliation': ""Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center at Houston, School of Public Health, & Department of Women's Healthy, The University of Texas at Austin, Dell Medical School, Austin, TX, United States.""}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Dean', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, 610 E 22nd St, Kansas City, MO 64108, United States; Department of Pediatrics, Developmental and Behavioral Sciences, Children's Mercy Kansas City, 2401 Gillham Rd., Kansas City, MO 64108, United States.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Department of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS 66160, United States.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Faith', 'Affiliation': 'Department of Counseling, School, and Educational Psychology, Graduate School of Education, University at Buffalo - SUNY, 420 Baldy Hall, Buffalo, NY 14260, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.001']
802,30630109,Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.,"BACKGROUND


Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protocol paper outlines the design, content, implementation, and evaluation of CHL.
METHODS/DESIGN


CHL integrates a parenting program co-led by Head Start staff and parents, enhanced nutrition support, and a media campaign. CHL content and implementation are informed by the Family Ecological Model, Psychological Empowerment Theory, and Organizational Empowerment Theory. The intervention is directed by community-based participatory research and implementation science principles, such as co‑leadership with parents and staff, and implementation in a real world context. CHL is evaluated in a three-year pragmatic cluster-randomized trial with a stepped wedge design. The primary outcome is change in child Body Mass Index z-score. Secondary outcomes include children's weight-related behaviors (i.e., diet, physical activity, screen use, and sleep), parenting practices targeted at these behaviors (e.g., food parenting), and parent empowerment. The evaluation capitalizes on routine health data collected by Head Start (e.g., child height and weight, diet) coupled with parent surveys completed by subsamples of families.
DISCUSSION


CHL is an innovative childhood obesity prevention program grounded in theory and implementation science principles. If successful, CHL is positioned for sustained implementation and nationwide Head Start scale-up.",2019,Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation.,"['A family-centered childhood obesity prevention program integrated into Head Start services', 'Communities for healthy living (CHL) ', 'Communities for Healthy Living (CHL']","['CHL', 'parenting program co-led by Head Start staff and parents, enhanced nutrition support, and a media campaign']","['change in child Body Mass Index z-score', ""children's weight-related behaviors (i.e., diet, physical activity, screen use, and sleep), parenting practices targeted at these behaviors (e.g., food parenting), and parent empowerment""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",,0.0427298,Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation.,"[{'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Beckerman', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: jbeckerman@g.harvard.edu.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Aftosmes-Tobio', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: aaftosme@hsph.harvard.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kitos', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Jurkowski', 'Affiliation': 'Department of Health Policy, Management & Behavior, University at Albany School of Public Health, 1 University Place, Rensselaer, NY 12144, United States. Electronic address: jjurkowski@albany.edu.'}, {'ForeName': 'Kindra', 'Initials': 'K', 'LastName': 'Lansburg', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Action for Boston Community Development, 178 Tremont Street, Boston, MA 02111, United States. Electronic address: kindra.lansburg@bostonabcd.org.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Kazik', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Community Action Agency of Somerville, 66 Union Square, Somerville, MA 02143, United States.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gavarkovs', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: adam_gavarkovs@g.harvard.edu.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Vigilante', 'Affiliation': 'Community Action Agency of Somerville, 66 Union Square, Somerville, MA 02143, United States. Electronic address: avigilante@caasomerville.org.'}, {'ForeName': 'Begum', 'Initials': 'B', 'LastName': 'Kalyoncu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Figueroa', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: rfigueroa@hsph.harvard.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Klabunde', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: rachel.klabunde@mail.harvard.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Barouch', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Haneuse', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: shaneuse@hsph.harvard.edu.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Taveras', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital for Children, 125 Nashua St, Suite 860, Boston, MA 02114, United States. Electronic address: elsie.taveras@mgh.harvard.edu.'}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Davison', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address: kdavison@hsph.harvard.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.002']
803,30703523,The Healthy Pregnancies Project: Study protocol and baseline characteristics for a cluster-randomized controlled trial of a community intervention to reduce tobacco use among Alaska Native pregnant women.,"BACKGROUND


Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics.
DESIGN


Cluster-randomized controlled trial with village as the unit of assignment. Sixteen villages in rural southwest Alaska were stratified on village size and randomized to a multicomponent intervention (n = 8 villages) or usual care (n = 8 villages).
METHODS


Pregnant AN women from the study villages were enrolled. All participants receive the usual care provided to pregnant women in this region. Participants from intervention villages additionally receive individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN ""Native Sisters."" Baseline measurements for all enrolled pregnant women have been completed. Follow-up assessments are ongoing at delivery, and at 2 and 6 months postpartum. The primary outcome is biochemically verified tobacco use status at 6 months postpartum.
RESULTS


Recruitment was feasible with 73% of eligible women screened enrolled. The program reached more than half (56%) of AN pregnant women from the study villages during the recruitment period. Participants are N = 352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages. At baseline, participants' mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users.
DISCUSSION


Processes and products from this project may have relevance to other Native American populations aiming to focus on healthy pregnancies in their communities.",2019,The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women.,"[""participants' mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users"", 'Sixteen villages in rural southwest Alaska', 'eligible women screened enrolled', 'Alaska Native pregnant women', 'enrolled pregnant women', 'AN women from the study villages were enrolled', 'Pregnant', 'Participants are N\u202f=\u202f352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages']","['multicomponent intervention', 'community intervention', 'individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN ""Native Sisters', 'multicomponent intervention (n\u202f=\u202f8 villages) or usual care (n\u202f=\u202f8 villages']",['tobacco use status at 6\u202fmonths postpartum'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0337514', 'cui_str': 'Sister'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.110876,The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women.,"[{'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: patten.christi@mayo.edu.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Lando', 'Affiliation': 'University of Minnesota, 1300 2(nd) St, Ste 200, Minneapolis, MN 55454, USA. Electronic address: lando001@umn.edu.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Desnoyers', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Christine_Desnoyers@ykhc.org.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Barrows', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Yvette_Barrows@ykhc.org.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Klejka', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Joseph_Klejka@ykhc.org.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Decker', 'Affiliation': 'Mayo Clinic, Department of Health Sciences Research, Harwick 7, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: decker.paul@mayo.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: hughes.christine@mayo.edu.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Bock', 'Affiliation': 'Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: bock.martha@mayo.edu.'}, {'ForeName': 'Rahnia', 'Initials': 'R', 'LastName': 'Boyer', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Rahnia_Boyer@ykhc.org.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'University of Michigan, 109 S. Observatory, 3867 SPH1, Ann Arbor, MI 48109, USA. Electronic address: kresnic@umich.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Burhansstipanov', 'Affiliation': 'Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 80470, USA. Electronic address: lindab@natamcancer.net.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.012']
804,30321476,Gestational Vitamin D Supplementation Leads to Reduced Perinatal RXRA DNA Methylation: Results From the MAVIDOS Trial.,"We have previously demonstrated inverse associations between maternal 25(OH)-vitamin D status and perinatal DNA methylation at the retinoid-X-receptor-alpha (RXRA) locus and between RXRA methylation and offspring bone mass. In this study, we used an existing randomized trial to test the hypothesis that maternal gestational vitamin D supplementation would lead to reduced perinatal RXRA locus DNA methylation. The Maternal Vitamin D Osteoporosis Study (MAVIDOS) was a multicenter, double-blind, randomized, placebo-controlled trial of 1000 IU/day cholecalciferol or matched placebo from 14 weeks' gestation until delivery. Umbilical cord (fetal) tissue was collected at birth and frozen at -80°C (n = 453). Pyrosequencing was used to undertake DNA methylation analysis at 10 CpG sites within the RXRA locus (identified previously). T tests were used to assess differences between treatment groups in methylation at the three most representative CpG sites. Overall, methylation levels were significantly lower in the umbilical cord from offspring of cholecalciferol-supplemented mothers, reaching statistical significance at four CpG sites, represented by CpG5: mean difference in % methylation between the supplemented and placebo groups was -1.98% (95% CI, -3.65 to -0.32, p = 0.02). ENCODE (Encyclopedia of DNA Elements) evidence supports the functionality of this locus with strong DNase hypersensitivity and enhancer chromatin within biologically relevant cell types including osteoblasts. Enrichment of the enhancer-related H3K4me1 histone mark is also seen in this region, as are binding sites for a range of transcription factors with roles in cell proliferation, response to stress, and growth factors. Our findings are consistent with previous observational results and provide new evidence that maternal gestational supplementation with cholecalciferol leads to altered perinatal epigenetic marking, informing mechanistic understanding of early life mechanisms related to maternal vitamin D status, epigenetic marks, and bone development. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.",2019,"Overall, methylation levels were significantly lower in the umbilical cord from offspring of cholecalciferol-supplemented mothers, reaching statistical significance at four CpG sites, represented by CpG5: mean difference in % methylation between the supplemented and placebo groups was -1.98% (95% CI, -3.65 to -0.32, p = 0.02).",[],"['placebo', 'Gestational Vitamin D Supplementation', 'cholecalciferol or matched placebo', 'ENCODE ', 'maternal gestational vitamin D supplementation', 'cholecalciferol']","['Perinatal RXRA DNA Methylation', 'Umbilical cord (fetal) tissue', 'Overall, methylation levels', 'perinatal RXRA locus DNA methylation']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0444089', 'cui_str': 'Umbilical cord tissue sample (specimen)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.231111,"Overall, methylation levels were significantly lower in the umbilical cord from offspring of cholecalciferol-supplemented mothers, reaching statistical significance at four CpG sites, represented by CpG5: mean difference in % methylation between the supplemented and placebo groups was -1.98% (95% CI, -3.65 to -0.32, p = 0.02).","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Curtis', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Krstic', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Eloïse', 'Initials': 'E', 'LastName': 'Cook', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': ""D'Angelo"", 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Crozier', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Moon', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murray', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Garratt', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Costello', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cleal', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Brogan', 'Initials': 'B', 'LastName': 'Ashley', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Bishop', 'Affiliation': ""Academic Unit of Child Health, Sheffield Children's Hospital, University of Sheffield, Sheffield, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kennedy', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aris T', 'Initials': 'AT', 'LastName': 'Papageorghiou', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Schoenmakers', 'Affiliation': 'MRC Elsie Widdowson Laboratory, Cambridge, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'Sheffield Hospitals NHS Trust, (University of Sheffield), Sheffield, UK.'}, {'ForeName': 'Saurabh V', 'Initials': 'SV', 'LastName': 'Gandhi', 'Affiliation': 'Sheffield Hospitals NHS Trust, (University of Sheffield), Sheffield, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': 'MRC Elsie Widdowson Laboratory, Cambridge, UK.'}, {'ForeName': 'M Kassim', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Inskip', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Bell', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Institute of Developmental Sciences, University of Southampton, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, UK.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3603']
805,30395904,Daily Lisinopril vs Placebo for Prevention of Chemoradiation-Induced Pulmonary Distress in Patients With Lung Cancer (Alliance MC1221): A Pilot Double-Blind Randomized Trial.,"PURPOSE


Chemoradiation (CRT) is an integral treatment modality for patients with locally advanced lung cancer. It has been hypothesized that current use of an angiotensin-converting enzyme inhibitor during CRT may be protective for treatment-related lung damage and pneumonitis.
METHODS AND MATERIALS


We conducted a pilot, double-blind, placebo-controlled, randomized trial. Study-eligible patients receiving curative thoracic radiation therapy (RT) were randomly assigned to 20 mg of lisinopril or placebo once daily during and up to 3 months after RT. All patients received concurrent chemotherapy. The primary endpoint was adverse event profiling. Multiple patient-reported outcome (PRO) surveys, including the Lung Cancer Symptom Scale, Function Assessment of Cancer Therapy-Lung, and the European Organisation for Research and Treatment of Cancer Lung Cancer Questionnaire, were applied with a symptom experience questionnaire. Exploratory comparative statistics were used to detect differences between arms with χ 2  and Kruskal-Wallis testing.
RESULTS


Five institutions enrolled 23 patients. However, accrual was less than expected. Eleven and 12 patients were in the placebo and lisinopril arms, respectively (mean age, 63.5 years; male, 62%). Baseline characteristics were balanced. Eighteen patients (86%) were former or current smokers. The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema). Few PRO measures suggested that compared with the placebo arm, patients receiving lisinopril had less cough, less shortness of breath, fewer symptoms from lung cancer, less dyspnea with both walking and climbing stairs, and better overall quality of life (for all, P < .05).
CONCLUSIONS


Although underpowered because of low accrual, our results suggest that there was a clinical signal for safety-and possibly beneficial by limited PRO measures-in concurrently administering lisinopril during thoracic CRT to mitigate or prevent RT-induced pulmonary distress. Our results showed that a definitive, larger-scale, randomized phase 3 trial is needed in the future.",2019,"The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema).","['Five institutions enrolled 23 patients', 'arms, respectively (mean age, 63.5\xa0years; male, 62', 'Patients With Lung Cancer', 'Study-eligible patients receiving curative thoracic radiation therapy (RT', 'Eighteen patients (86%) were former or current smokers', 'patients with locally advanced lung cancer']","['Alliance MC1221', 'lisinopril', 'Chemoradiation (CRT', 'placebo', 'lisinopril or placebo', 'Daily Lisinopril vs Placebo', 'concurrent chemotherapy', 'placebo and lisinopril']","['Lung Cancer Symptom Scale, Function Assessment of Cancer Therapy-Lung, and the European Organisation for Research and Treatment of Cancer Lung Cancer Questionnaire', 'cough, less shortness of breath, fewer symptoms from lung cancer, less dyspnea with both walking and climbing stairs', 'overall quality of life', 'grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema', 'adverse event profiling']","[{'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C3241966'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",23.0,0.302562,"The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema).","[{'ForeName': 'Terence T', 'Initials': 'TT', 'LastName': 'Sio', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona. Electronic address: Sio.Terence@mayo.edu.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Ken', 'Initials': 'WK', 'LastName': 'Zhen', 'Affiliation': 'Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yolanda I', 'Initials': 'YI', 'LastName': 'Garces', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Leenstra', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jean-Claude M', 'Initials': 'JM', 'LastName': 'Rwigema', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.'}, {'ForeName': 'Shaker', 'Initials': 'S', 'LastName': 'Dakhil', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Kansas, Wichita, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bearden', 'Affiliation': 'Department of Radiation Oncology, Spartanburg Medical Center, Spartanburg, South Carolina.'}, {'ForeName': 'Sonja J', 'Initials': 'SJ', 'LastName': 'van der Veen', 'Affiliation': 'Department of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Apar K', 'Initials': 'AK', 'LastName': 'Ganti', 'Affiliation': 'Division of Oncology-Hematology, Department of Internal Medicine, VA Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Miller', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2018.10.035']
806,30428750,Testing active choice for screening practitioner's gender in endoscopy among disinclined women: An online experiment.,"OBJECTIVES


A large proportion of women have a preference for a same-gender endoscopy practitioner. We tested how information about practitioner gender affected intention to have bowel scope screening in a sample of women disinclined to have the test.
METHODS


In an online experimental survey, women aged 35-54 living in England who did not intend to participate in bowel scope screening (N = 1060) were randomised to one of four experimental conditions: (1) control (practitioner's gender is unknown), (2) opposite-gender (male practitioner by default), (3) same gender (female practitioner by default), and (4) active choice (the patient could choose the gender of the practitioner). Intention was measured following the interventions.
RESULTS


Of 1010 (95.3%) women who completed the survey, most were White-British (83.6%), and working (63.3%). Compared with control, both active choice and same-gender conditions increased intention among disinclined women (9.3% vs. 16.0% and 17.9%; OR: 1.85; 95% CI: 1.07-3.20 and OR: 2.07; 95% CI: 1.23-3.50). There were no differences in intention between the opposite-gender and control conditions (9.8% vs. 9.3%; OR: 1.06; 95% CI: 0.60-1.90) or the active choice and same-gender conditions (16.0% vs. 17.9%: OR: 0.89; 95% CI: 0.55-1.46, using same gender as baseline).
CONCLUSIONS


Offering disinclined women a same-gender practitioner, either by choice or default, increased subsequent intention, while an opposite gender default did not negatively affect intention. Reducing uncertainty about gender of practitioner could positively affect uptake in women, and should be tested in a randomised controlled trial.",2019,"There were no differences in intention between the opposite-gender and control conditions (9.8% vs. 9.3%; OR: 1.06; 95% CI: 0.60-1.90) or the active choice and same-gender conditions (16.0% vs. 17.9%: OR: 0.89; 95% CI: 0.55-1.46, using same gender as baseline).
","['women aged 35-54 living in England who did not intend to participate in bowel scope screening (N\u2009=\u20091060', 'Of 1010 (95.3%) women who completed the survey, most were White-British (83.6%), and working (63.3', ""screening practitioner's gender in endoscopy among disinclined women""]","[""control (practitioner's gender is unknown), (2) opposite-gender (male practitioner by default), (3) same gender (female practitioner by default), and (4) active choice""]",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",[],1060.0,0.200712,"There were no differences in intention between the opposite-gender and control conditions (9.8% vs. 9.3%; OR: 1.06; 95% CI: 0.60-1.90) or the active choice and same-gender conditions (16.0% vs. 17.9%: OR: 0.89; 95% CI: 0.55-1.46, using same gender as baseline).
","[{'ForeName': 'Sandro T', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ghanouni', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Lesley M', 'Initials': 'LM', 'LastName': 'McGregor', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Verstraete', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Ailish', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Journal of medical screening,['10.1177/0969141318806322']
807,30433852,Bladder Preservation With Twice-a-Day Radiation Plus Fluorouracil/Cisplatin or Once Daily Radiation Plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,"PURPOSE


Fluorouracil plus cisplatin and radiation twice a day (FCT) is an established chemoradiation (CRT) regimen for selective bladder-sparing treatment of muscle-invasive bladder cancer. Gemcitabine and once daily radiation (GD) is a well-supported alternative. The current trial evaluates these regimens.
METHODS


Patients with cT2-4a muscle-invasive bladder cancer were randomly assigned to FCT or GD. Patients underwent transurethral resection and induction CRT to 40 Gy. Patients who achieved a complete response (CR) received consolidation CRT to 64 Gy and others underwent cystectomy. We administered adjuvant gemcitabine/cisplatin chemotherapy. The primary end point was the rate of freedom from distant metastasis at 3 years (DMF3). The trial was not statistically powered to compare regimens, but to assess whether either regimen exceeded a DMF3 benchmark of 75%. Toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival at 3 years (BI-DMFS3), were assessed.
RESULTS


From December 2008 to April 2014, 70 patients were enrolled, of which 66 were eligible for analysis, 33 per arm. Median follow-up was 5.1 years (range, 0.4 to 7.8 years) for eligible living patients. DMF3 was 78% and 84% for FCT and GD, respectively. BI-DMFS3 was 67% and 72%, respectively. Postinduction CR rates were 88% and 78%, respectively. Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively. For the 33 patients in the GD arm, these figures were 18 (55%) overall and 14 (42%), three (9%) and two patients (6%), respectively.
CONCLUSION


Both regimens demonstrated DMF3 greater than 75%. There were fewer toxicities observed in the GD arm. Either gemcitabine and once daily radiation or a cisplatin-based regimen could serve as a base for future trials of systemic therapy.",2019,"Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively.","['Muscle-Invasive Bladder Cancer', 'Patients who achieved a complete response (CR) received', '70 patients were enrolled, of which 66 were eligible for analysis, 33 per arm', 'From December 2008 to April 2014', 'Patients with cT2-4a muscle-invasive bladder cancer', 'muscle-invasive bladder cancer']","['adjuvant gemcitabine/cisplatin chemotherapy', 'FCT', 'transurethral resection and induction CRT', 'Gemcitabine and once daily radiation (GD', 'gemcitabine and once daily radiation or a cisplatin-based regimen', 'FCT or GD', 'Fluorouracil plus cisplatin and radiation twice a day (FCT', 'Bladder Preservation With Twice-a-Day Radiation Plus Fluorouracil/Cisplatin or Once Daily Radiation Plus Gemcitabine', 'consolidation CRT']","['Postinduction CR rates', 'DMF3', 'rate of freedom from distant metastasis at 3 years (DMF3', 'toxicities', 'treatment-related grade 3 and 4 toxicities', 'experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity', 'Toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",70.0,0.0660889,"Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Coen', 'Affiliation': '1 21st Century Oncology, Providence, RI.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': '2 NRG Oncology, Philadelphia, PA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Saylor', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Cheryl T', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': '4 Ohio State University, Columbus, OH.'}, {'ForeName': 'Chin-Lee', 'Initials': 'CL', 'LastName': 'Wu', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Parker', 'Affiliation': '5 McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lautenschlaeger', 'Affiliation': '6 Indiana University Cancer Center, Indianapolis, IN.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ashesh B', 'Initials': 'AB', 'LastName': 'Jani', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Kucuk', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': '5 McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Rodgers', 'Affiliation': '2 NRG Oncology, Philadelphia, PA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00537']
808,30462830,"Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies.","OBJECTIVE


To examine the likelihood of response with continued galcanezumab treatment in patients with episodic or chronic migraine without initial clinical improvement.
BACKGROUND


A percentage of patients with migraine may require additional time on pharmacotherapy but discontinue treatment prematurely. Additionally, recognizing when continued treatment is unlikely to provide improvement limits unnecessary exposure.
METHODS


Post hoc analysis of response after continued galcanezumab treatment was conducted in a subset of patients with episodic (N = 879) and chronic (N = 555) migraine who did not achieve ""good"" early improvement (episodic, ≥50% reduction in baseline migraine headache days [MHD] and chronic, ≥30% reduction) after 1 month of dosing (NR-1; episodic, n = 450 and chronic, n = 306). This subset was categorized by level of reduction in MHD during 1 month of treatment: ""modest"" (>30% to <50% fewer MHD for episodic and >10% to <30% fewer MHD for chronic), ""limited"" (episodic only; >10% to ≤30% fewer MHD), or ""minimal/no"" early improvement (≤10% fewer MHD to ≤10% more MHD), or ""worsening"" (>10% more MHD). The percentages of patients having ""better"" (≥75% fewer MHD for episodic and ≥50% for chronic), ""good,"" or ""little-to-no"" (≤10% fewer MHD) response during the remaining treatment period were calculated for each category. Similarly, the subset of NR-1 patients who did not achieve ""good"" early improvement after 2 months of treatment (NR-2; episodic, n = 290 and chronic, n = 240) were categorized by level of their average monthly reduction across 1 and 2 months using similar categories.
RESULTS


Of NR-1 patients with episodic migraine having ""modest"" early improvement, 62% (96/155) achieved ""good"" and 20% (31/155) achieved ""better"" responses with continued treatment. A percentage of patients with ""limited"" (43%; 46/108) or ""minimal/no"" (34%; 29/85) early improvement, or ""worsening"" (20%; 20/102) achieved a ""good"" response after continued treatment. A percentage of NR-1 patients with chronic migraine having ""modest"" early improvement achieved ""good"" (38%; 44/116) and ""better"" (13%; 15/116) responses with continued treatment. A ""good"" response was achieved for a percentage of patients with ""minimal/no"" early improvement (17%; 23/133). Similar patterns were observed for the NR-2 subset, though percentages were lower.
CONCLUSIONS


Galcanezumab-treated patients with episodic or chronic migraine without response following 1 or 2 months of treatment appear to have a reasonable likelihood of continued improvement in months following initial treatment and this opportunity is more likely in patients showing greater early improvements. While a small percentage of patients with episodic or chronic migraine who experienced worsening in the number of MHD following initial treatment responded with continued treatment, most do not show substantial reduction in MHD. Overall benefit of therapy should be determined collaboratively between the patient and physician.",2019,"The percentages of patients having ""better"" (≥75% fewer MHD for episodic and ≥50% for chronic), ""good,"" or ""little-to-no"" (≤10% fewer MHD) response during the remaining treatment period were calculated for each category.","['patients with episodic (N\xa0=\xa0879) and chronic (N\xa0=\xa0555) migraine who did not achieve ""good"" early improvement (episodic, ≥50% reduction in baseline migraine headache days [MHD] and chronic, ≥30% reduction) after 1 month of dosing (NR-1; episodic, n\xa0=\xa0450 and chronic, n\xa0=\xa0306', 'patients with episodic or chronic migraine without initial clinical improvement', 'Patients With Episodic or Chronic Migraine']","['Placebo', 'Galcanezumab', 'galcanezumab treatment', 'galcanezumab']","['good"" early improvement', 'good"" response', 'good', 'better"" responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4517810', 'cui_str': 'Five hundred and fifty-five'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",240.0,0.0310757,"The percentages of patients having ""better"" (≥75% fewer MHD for episodic and ≥50% for chronic), ""good,"" or ""little-to-no"" (≤10% fewer MHD) response during the remaining treatment period were calculated for each category.","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'Eli Lilly and Company, and/or one of its subsidiaries, Indianapolis, IN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, and/or one of its subsidiaries, Indianapolis, IN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sacco', 'Affiliation': 'Carolinas Headache Clinic, Matthews, NC, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Ruff', 'Affiliation': 'Eli Lilly and Company, and/or one of its subsidiaries, Indianapolis, IN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, and/or one of its subsidiaries, Indianapolis, IN, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, and/or one of its subsidiaries, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13443']
809,30252544,Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC): a cluster randomized control trial evaluating dissemination of an evidence-based shared decision-making intervention for asthma management.,"Objective : To compare three dissemination approaches for implementing an asthma shared decision-making (SDM) intervention into primary care practices.  Methods : We randomized thirty practices into three study arms: (1) a facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention. Patient perceptions of SDM were assessed in the active intervention arms using a one-question anonymous survey. Logistic regression models compared the frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions) between the three arms.  Results : We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites. Patients were more likely to report that they participated equally with the provider in making the treatment decision in the facilitator-led sites (75% vs. 66%,  p  = 0.001). Comparisons of outcomes for patients in the facilitator-led ( n  = 1,658) and lunch-and-learn ( n  = 2,613) arms respectively vs. control ( n  = 2,273) showed no significant differences for ED visits (Odds Ratio [OR] [95%CI] = 0.77[0.57-1.04]; 0.83[0.66-1.07]), hospitalizations (OR [95%CI] = 1.30[0.59-2.89]; 1.40 [0.68-3.06]), or oral steroids (OR [95%CI] =0.95[0.79-1.15]; 1.03[0.81-1.06]).  Conclusion : Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach. While there was no significant difference in health outcomes between the three arms, the results were most likely confounded by a concurrent statewide asthma initiative and the pragmatic implementation of the intervention. These results offer support for the use of structured approaches such as facilitator-led dissemination of complex interventions into primary care practices.",2019,"CONCLUSION


Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","['We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites', 'Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC']",['facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention'],"['health outcomes', 'frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions', 'ED visits']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",30.0,0.150132,"CONCLUSION


Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ludden', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Shade', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Reeves', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Welch', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Yhenneko J', 'Initials': 'YJ', 'LastName': 'Taylor', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Sveta', 'Initials': 'S', 'LastName': 'Mohanan', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Coyne-Beasley', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Division General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bray', 'Affiliation': 'Vidant Medical Group, Greenville, NC, USA.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Tapp', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1514630']
810,30247552,Dietary Patterns and Self-reported Incident Disability in Older Adults.,"BACKGROUND OR OBJECTIVES


Disability in older adults is associated with low quality of life and higher mortality. Diet may be a potentially important public health strategy for disability prevention in aging. We examined the relations of the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diets to functional disability in the Rush Memory and Aging Project.
METHODS


A total of 809 participants (mean age = 80.7 ± 7.2 years, 74% female) without functional disability at baseline were followed for an average of 5.3 years. Standardized measures for self-reported disability including, activities of daily living ADL), instrumental ADL, and mobility disability were assessed annually. The diet scores were computed based on a validated food frequency questionnaire administered at baseline.
RESULTS


In Cox proportional hazards models adjusted for age, sex, education, smoking, physical activity, and total calories, the second (hazard ratio = 0.75, 95% CI: 0.60-0.95) and third tertiles (hazard ratio = 0.67, 95% CI: 0.53-0.86) of MIND diet scores had lower rates of ADL disability compared to the lowest tertile (p for trend = .001), whereas only the third tertiles of the Mediterranean (hazard ratio = 0.73, 95% CI: 0.57-0.94) and DASH (hazard ratio = 0.75, 95% CI: 0.59-0.95) diets were significantly associated with ADL disability. Instrumental ADL disability was inversely and linearly associated with the MIND diet score only (p for trend = .04). Mobility disability was associated with the MIND (p for trend = .02), Mediterranean (p for trend = .05) and DASH (p for trend = .02) diet scores.
CONCLUSION


These findings are encouraging that diet may be an effective strategy for the prevention of functional disability in older adults.",2019,Instrumental ADL disability was inversely and linearly associated with the MIND diet score only (p for trend = .04).,"['A total of 809 participants (mean age = 80.7 ± 7.2 years, 74% female) without functional disability at baseline were followed for an average of 5.3 years', 'Older Adults', 'older adults']","['Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention']","['Mobility disability', 'disability including, activities of daily living ADL), instrumental ADL, and mobility disability', 'Mediterranean', 'ADL disability', 'Instrumental ADL disability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living (assessment scale)'}]",809.0,0.0634269,Instrumental ADL disability was inversely and linearly associated with the MIND diet score only (p for trend = .04).,"[{'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Rush Institute of Healthy Aging, Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Rush Institute of Healthy Aging, Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Aron S', 'Initials': 'AS', 'LastName': 'Buchman', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bennett', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Morris', 'Affiliation': 'Rush Institute of Healthy Aging, Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly211']
811,30256905,"The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial.","BACKGROUND


Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and systemic reactions. This study assessed the impact of RZV on the quality of life and daily functioning of participants and implications for caregivers.
METHODS


Four hundred and one adults aged 50 years or older received single RZV doses at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2.
RESULTS


The most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%), and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%), and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased.
CONCLUSIONS


Overall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.",2019,"No clinically meaningful reductions in mean SF-36 PF scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary endpoint) and no overall quality-adjusted-life-year loss was recorded post-dose-1.","['participants and implications for caregivers', '401 adults aged ≥50 years received', 'older adults']","['RZV', 'single RZV', 'recombinant zoster vaccine', 'recombinant zoster vaccine (RZV']","['swelling', 'lost workdays; caregiver workload', 'Grade 3 reactogenicity', 'SF-36 PF score (impacting activities such as walking, carrying groceries, climbing stairs', 'mean SF-36 PF scale scores', 'headache', 'mean SF-36 Physical Functioning (PF) score', 'physical functioning and quality of life', 'redness', 'overall quality-adjusted-life-year loss', 'QoL, reactogenicity, safety, productivity loss and healthcare resource utilization', 'myalgia']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",401.0,0.225848,"No clinically meaningful reductions in mean SF-36 PF scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary endpoint) and no overall quality-adjusted-life-year loss was recorded post-dose-1.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, North Carolina.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Grupping', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butuk', 'Affiliation': 'Solaris Clinical Research, Meridian, Idaho.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The Corvallis Clinic, Oregon.'}, {'ForeName': 'Mohamed El', 'Initials': 'ME', 'LastName': 'Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Fissette', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, South Carolina.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hartley', 'Affiliation': 'Preferred Primary Care Physicians, Uniontown, Pennsylvania.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Oakland, California.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nevarez', 'Affiliation': 'DaVita Medical Group, Colorado Springs, Colorado.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Uusinarkaus', 'Affiliation': 'DaVita Medical Group, Colorado Springs, Colorado.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly218']
812,29236526,"Effects of Varying Color, Imagery, and Text of Cigarette Package Warning Labels among Socioeconomically Disadvantaged Middle School Youth and Adult Smokers.","The U.S. Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) of 2009 paved the way for the Food and Drug Administration (FDA) to propose nine different graphic warning labels (GWLs) intended for prominent placement on the front and back of cigarette packs and on cigarette advertisements. Those GWLs were adjudicated as unconstitutional on the ground that they unnecessarily infringed tobacco companies' free speech without sufficiently advancing the government's public health interests. This study examines whether less extensive alternatives to the original full-color GWLs, including black-and-white GWLs and text-only options, have similar or divergent effects on visual attention, negative affect, and health risk beliefs. We used a mobile media research lab to conduct a randomized experiment with two populations residing in socioeconomically disadvantaged communities: biochemically confirmed adult smokers (N = 313) and middle school youth (N = 340). Results indicate that full-color GWLs capture attention for longer than black-and-white GWLs among both youth and adult smokers. Among adults, packages with GWLs (in either color or black-and-white) engendered more negative affect than those with text-only labels, while text-only produced greater negative affect than the packages with brand imagery only. Among youth, GWLs and text-only labels produced comparable levels of negative affect, albeit more so than brand imagery. We thus offer mixed findings related to the claim that a less extensive alternative could satisfy the government's compelling public health interest to reduce cigarette smoking rates.",2019,"Among youth, GWLs and text-only labels produced comparable levels of negative affect, albeit more so than brand imagery.","['socioeconomically disadvantaged communities: biochemically confirmed adult smokers (N\xa0=\xa0313) and middle school youth (N\xa0=\xa0340', 'Socioeconomically Disadvantaged Middle School Youth and Adult Smokers']","['Tobacco Control Act (Tobacco Control Act) of 2009 paved the way for the Food and Drug Administration (FDA) to propose nine different graphic warning labels (GWLs) intended for prominent placement on the front and back of cigarette packs and on cigarette advertisements', 'Varying Color, Imagery, and Text of Cigarette Package Warning Labels']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0205402', 'cui_str': 'Prominent (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C1704710', 'cui_str': 'Package'}]",[],,0.0151906,"Among youth, GWLs and text-only labels produced comparable levels of negative affect, albeit more so than brand imagery.","[{'ForeName': 'Sahara', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Greiner Safi', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Deena', 'Initials': 'D', 'LastName': 'Kemp', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Christofer', 'Initials': 'C', 'LastName': 'Skurka', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Davydova', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Scolere', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Mathios', 'Affiliation': 'b College of Human Ecology , Cornell University.'}, {'ForeName': 'Rosemary J', 'Initials': 'RJ', 'LastName': 'Avery', 'Affiliation': 'c Department of Policy Analysis and Management , Cornell University.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Dorf', 'Affiliation': 'd Cornell Law School , Cornell University.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Steinhardt', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'a Department of Communication , Cornell University.'}]",Health communication,['10.1080/10410236.2017.1407228']
813,31660332,"Impact of Tenofovir-Based Pre-exposure Prophylaxis on Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism in HIV-Negative Adults.","Background


Pre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) reduces the risk of HIV seroconversion but may promote bone mineral density (BMD) decline. The mechanisms of BMD decline with FTC/TDF remain unclear, and studies in HIV-positive individuals have been confounded by the effects of HIV and concomitant antiretroviral medications. We evaluated the impact of FTC/TDF on biomarkers of bone remodeling and bone mineral metabolism in HIV-negative men and women enrolled in the Partners PrEP Study.
Methods


In a random sample of HIV-negative participants randomized to FTC/TDF PrEP (n = 50) or placebo (n = 50), serum parathyroid hormone (PTH), bone biomarkers (C-telopeptide, procollagen 1 intact N-terminal propeptide, and sclerostin), and plasma fibroblast growth factor 23 were measured at baseline and month 24, and the percentage change was compared between groups. In a complementary analysis, we compared the change in biomarkers between participants with and without a 25% decline in glomerular filtration rate (GFR) on FTC/TDF.
Results


Baseline characteristics were similar between the groups (median age, 38 years; 40% women). Vitamin D insufficiency was common, but baseline GFR and PTH were in the normal range. We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo ( P  = .03), suggesting an increase in bone remodeling. We observed no differences in the other biomarkers, or in a separate analysis comparing participants with and without a decline in GFR.
Conclusions


Increased bone remodeling may mediate the BMD decline observed with tenofovir-containing PrEP and antiretroviral therapy, independent of a TDF-mediated decrease in kidney function.",2019,"We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo ( P  = .03), suggesting an increase in bone remodeling.","['HIV-negative men and women enrolled in the Partners PrEP Study', 'HIV-Negative Adults']","['Tenofovir-Based Pre-exposure Prophylaxis', 'FTC/TDF PrEP', 'FTC)/tenofovir disoproxil fumarate (TDF', 'placebo', 'FTC/TDF', '\n\n\nPre-exposure prophylaxis (PrEP) with emtricitabine']","['glomerular filtration rate (GFR) on FTC/TDF', 'bone remodeling and bone mineral metabolism', 'bone mineral density (BMD) decline', 'Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism', 'bone remodeling', 'serum parathyroid hormone (PTH), bone biomarkers (C-telopeptide, procollagen 1 intact N-terminal propeptide, and sclerostin), and plasma fibroblast growth factor 23', 'serum C-telopeptide', 'kidney function']","[{'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.488758,"We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo ( P  = .03), suggesting an increase in bone remodeling.","[{'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Nickolas', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Mugwanya', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Branch', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Janaina', 'Initials': 'J', 'LastName': 'Ramalho', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Nandakumar', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Dworakowski', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Wanga', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Nelly R', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Ronald', 'Affiliation': 'Departments of Medicine and Medical Microbiology, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Department of Medical Center, Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofz338']
814,29885777,Effect of baseline micronutrient and inflammation status on CD4 recovery post-cART initiation in the multinational PEARLS trial.,"BACKGROUND & AIMS


Nutritional deficiency and inflammation may impact CD4+ T cell recovery during combination antiretroviral therapy (cART), particularly in resource-limited settings where malnutrition is prevalent. The aim of this study was to investigate the relationship of micronutrient and inflammation biomarkers to CD4 recovery after cART initiation.
METHODS


We conducted a secondary analysis of a random sub-cohort sample (n = 270) from a multinational randomized trial of cART regimen efficacy among 1571 cART-naïve adults. We measured pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers. Biomarker status (i.e. micronutrient deficiency vs. sufficiency and elevated vs. low inflammation) was defined using established cutoffs or quartiles. Mixed-effects linear regression models were used to determine the association of baseline (pre-cART) concentrations of individual biomarkers with CD4 recovery through 96 weeks post-cART initiation.
RESULTS


In models adjusting for time-dependent viral load and baseline CD4 count, age, sex, body mass index, country, treatment regimen, anemia and hypoalbuminemia status, pre-cART vitamin D deficiency was associated with lower CD4 recovery (-14.9 cells/mm 3 , 95% CI: -27.9, -1.8) compared to sufficiency. In contrast, baseline selenium deficiency (20.8 cells/mm 3 , 95% CI: 3.3, 38.3), vitamin A deficiency (35.9 cells/mm 3 , 95% CI: 17.6, 54.3) and high sCD14 (23.4 cells/mm 3 , 95% CI: 8.9, 37.8) were associated with higher CD4 recovery compared to sufficient/low inflammation status.
CONCLUSIONS


In summary, baseline vitamin D deficiency was associated with diminished CD4 recovery after cART initiation; impaired CD4 recovery may contribute to the poor clinical outcomes recently observed in individuals with vitamin D deficiency. Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.",2019,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","['random sub-cohort sample (n\xa0=\xa0270', '1571 cART-naïve adults']","['cART', 'combination antiretroviral therapy (cART']","['CD4 recovery', 'baseline selenium deficiency', 'pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers', 'vitamin A deficiency']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0238421', 'cui_str': 'Selenium deficiency (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042842', 'cui_str': 'Vitamin A Deficiency'}]",,0.325259,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","[{'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Shivakoti', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: rshivak1@jhmi.edu.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Ewald', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: erewald@gmail.com.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: nikhil_jhumit@yahoo.com.'}, {'ForeName': 'Wei-Teng', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: weiteng.yang@gmail.com.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'UNC Lilongwe, Lilongwe, Malawi. Electronic address: ckanyama@unclilongwe.org.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil. Electronic address: sandra.wagner@ipec.fiocruz.br.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Nossa Senhora de Conceição, Porto Alegre, Brazil. Electronic address: breno@ghc.com.br.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand. Electronic address: khuanchai@rihes.org.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Department of Medicine, University of Witwatersrand, Johannesburg, South Africa. Electronic address: sfaesen@witshealth.co.za.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'IMPACT PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru. Electronic address: jrlama@impactaperu.org.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'University of KwaZulu Natal, Nelson R Mandela School of Medicine, Durban, South Africa. Electronic address: umeshlalloo@gmail.com.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Zulu', 'Affiliation': 'Malawi College of Medicine - Johns Hopkins Research Project, Kachere Rehabilitation Centre, Blantyre, Malawi. Electronic address: nez4@cdc.gov.'}, {'ForeName': 'Jyoti S', 'Initials': 'JS', 'LastName': 'Pawar', 'Affiliation': 'National AIDS Research Institute, Pune, India. Electronic address: jyotispawar.pawar@gmail.com.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': 'Les Centres GHESKIO, Port-Au-Prince, Haiti. Electronic address: cynthiariviere@yahoo.com.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YR Gaitonde Center for AIDS Research and Education, Chennai, India. Electronic address: kumarasamy@yrgcare.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe. Electronic address: jhakim@mweb.co.zw.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pollard', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: rbpollard@ucdavis.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Detrick', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: bdetrick@jhmi.edu.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Balagopal', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: abalago1@jhmi.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Asmuth', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: dasmuth@ucdavis.edu.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Semba', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rdsemba@jhmi.edu.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Thomas.Campbell@ucdenver.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golub', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: jgolub@jhmi.edu.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: agupta25@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.014']
815,31499249,"Rapid Recurrence of Eosinophilic Esophagitis Activity After Successful Treatment in the Observation Phase of a Randomized, Double-Blind, Double-Dummy Trial.","BACKGROUND & AIMS


Eosinophilic esophagitis (EoE) is chronic and recurs if treatment is discontinued. We aimed to determine rates of recurrence, and whether initial treatment with oral viscous budesonide (OVB) resulted in less recurrence than fluticasone from a multidose inhaler (MDI).
METHODS


This was the observation phase of a randomized, double-blind, double-dummy trial comparing OVB with MDI for initial EoE treatment. Subjects with a histologic response (<15 eosinophils/high-power field) in the trial entered an observation phase in which treatment was discontinued and symptoms were monitored. Patients underwent an endoscopy or a biopsy when symptoms recurred or at 1 year. We analyzed time to symptom recurrence and assessed endoscopic severity and histologic relapse (≥15 eosinophils/high-power field) at follow-up endoscopy.
RESULTS


Thirty-three of the 58 subjects (57%) had symptom recurrence before 1 year. The overall median time to symptom recurrence was 244 days. There was no difference in the rate of symptom recurrence for subjects treated with OVB vs MDI (hazard ratio, 1.04; 95% CI, 0.52-2.08). At symptom recurrence, 78% of patients had histologic relapse. The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P < .001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P < .001) compared with end of treatment.
CONCLUSIONS


EoE disease activity recurred rapidly after initial histologic response to topical steroids (either OVB or MDI). Because most subjects had recurrent endoscopic and histologic signs not reliably detected by symptoms, maintenance therapy should be recommended in EoE patients achieving histologic response to topical steroids. Clinicaltrials.gov no: NCT02019758.",2020,"The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P<.001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P<.001) compared to end-of-treatment.
",['Subjects with histologic response (fewer than 15 eosinophils/high-power field'],"['oral viscous budesonide (OVB', 'fluticasone', 'endoscopy or biopsy']","['histologic relapse', 'Eosinophilic Esophagitis Activity', 'mean Dysphagia Symptom Questionnaire score', 'overall median time to symptom recurrence', 'rate of symptom recurrence', 'symptom recurrence', 'histologic response', 'recurrent endoscopic and histologic signs', 'time to symptom recurrence and assessed endoscopic severity and histologic relapse', 'EoE Endoscopic Reference Score']","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4524105', 'cui_str': 'Symptom recurrence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.697784,"The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P<.001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P<.001) compared to end-of-treatment.
","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Arrington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'McGee', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Covington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Moist', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Gebhart', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Galanko', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Shaheen', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.050']
816,32144531,Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"PURPOSE


Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC).
METHODS


This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up.
RESULTS


After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar.
CONCLUSIONS


PC leads to faster healing compared to S, with similar healthcare burden.
TRIAL REGISTRATION


The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.",2020,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"['patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps', 'patients with chronic PD between 2012 and 2017', 'pilonidal disease', 'Patients with chronic symptomatic PD']","['Conservative Sinusectomy vs. excision and primary off-midline closure', 'conservative sinusectomy (S) to excision and paramedian primary closure (PC']","['total healing time, pain, time off work, patient satisfaction and recurrence at 1\xa0year', 'Median time to complete healing', 'Number of outpatient visits, time off work, analgesia requirement, and recurrence rates', 'rate of patients healed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001304', 'cui_str': 'Acute abscess (morphologic abnormality)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4544575', 'cui_str': 'Rotation flap (substance)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",,0.118992,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo Ferrario Di Tor', 'Initials': 'AFDT', 'LastName': 'Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Department of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}]",International journal of colorectal disease,['10.1007/s00384-020-03551-9']
817,30576507,Neonatal vitamin A supplementation and immune responses to oral polio vaccine in Zimbabwean infants.,"BACKGROUND


Micronutrient deficiencies may contribute to reduced oral vaccine immunogenicity in developing countries. We hypothesised that neonatal vitamin A supplementation (NVAS) would improve oral vaccine responses.
METHODS


We performed a cross-sectional study of infants recruited at birth to the Zimbabwe Vitamin A for Mothers and Babies (ZVITAMBO) trial, a randomised controlled trial of single, high-dose NVAS vs placebo conducted in Zimbabwe between 1997-2001. We measured poliovirus-specific IgA to type 1-3 polio strains by semiquantitative capture ELISA in cryopreserved plasma samples collected at 6 months of age.
RESULTS


A total of 181 infants fulfilled inclusion criteria, of whom 80 were randomised to NVAS and 101 to placebo. There were no significant differences in baseline characteristics between groups. At 6 months of age, median (IQR) vaccine titres for infants randomised to NVAS vs placebo were 932 (421-3001) vs 1774 (711-5431) for Sabin-1 (p=0.04); 1361 (705-3402) vs 2309 (1081-4283) for Sabin-2 (p=0.15); and 1584 (796-4216) vs 2260 (996-5723) for Sabin-3 (p=0.14), respectively. After adjusting for breast feeding status, birth weight, season and infant sex in a linear regression model, there was only weak evidence of difference in log mean titres between vitamin A and placebo groups for Sabin-1 (p=0.08) and no evidence of difference in log mean titres for Sabin-2 and Sabin-3.
CONCLUSIONS


NVAS did not augment oral polio vaccine responses in Zimbabwean infants. Further research is required to understand the impact of NVAS on responses to other oral vaccines.The trial is registered with clinicaltrials.gov identifier: NCT00198718.",2019,"Sabin-3.
CONCLUSIONS


NVAS did not augment oral polio vaccine responses in Zimbabwean infants.","['infants recruited at birth to the Zimbabwe Vitamin A for Mothers and Babies (ZVITAMBO) trial', 'conducted in Zimbabwe between 1997-2001', 'Zimbabwean infants', '181 infants fulfilled inclusion criteria, of whom 80 were randomised to']","['placebo', 'Neonatal vitamin A supplementation', 'neonatal vitamin A supplementation (NVAS', 'NVAS vs placebo', 'NVAS']","['median (IQR) vaccine titres', 'oral polio vaccine responses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}]",,0.687166,"Sabin-3.
CONCLUSIONS


NVAS did not augment oral polio vaccine responses in Zimbabwean infants.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vemont, Burlington, VT, USA.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Diehl', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vemont, Burlington, VT, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vemont, Burlington, VT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, 16 Lauchlan Avenue, Harare, Zimbabwe.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/try126']
818,31825939,The Effect of Body Mass Index on Outcome after Endovascular Treatment in Acute Ischemic Stroke Patients: A Post Hoc Analysis of the MR CLEAN Trial.,"BACKGROUND


Though obesity is a well-known risk factor for vascular disease, the impact of obesity on stroke outcome has been disputed. Several studies have shown that obesity is associated with better functional outcome after stroke. Whether obesity influences the benefit of endovascular treatment (EVT) in stroke patients is unknown. We evaluated the association between body mass index (BMI) and outcome in acute ischemic stroke patients with large vessel -occlusion (LVO), and assessed whether BMI affects the -benefit of EVT.
METHODS


This is a post hoc analysis of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial (-ISRCTN10888758). BMI was used as a continuous and categorical variable, distinguishing underweight and normal weight (BMI <25), overweight (BMI 25-30), and obesity (BMI ≥30). We used multivariable ordinal logistic regression analysis to estimate the association of BMI with functional outcome (shift analysis), assessed with modified Rankin Scale (mRs) at 90 days. The impact of BMI on EVT effect was tested by the use of a multiplicative interaction term.
RESULTS


Of 366 patients, 160 (44%) were underweight or normal weight, 145 (40%) overweight, and 61 (17%) were obese. In multivariable analysis with BMI as a continuous variable, we found a shift toward better functional outcome with higher BMI (mRS adjusted common OR 1.04; 95% CI 1.0-1.09), and mortality was inversely related to BMI (aOR 0.92; 95% CI 0.85-0.99). Safety analysis showed that higher BMI was associated with lower risk of stroke progression (aOR 0.92, 95% CI 0.87-0.99). Additional analysis showed no interaction between BMI and EVT effect on functional outcome, mortality, and other safety outcomes.
CONCLUSION


Our study confirms the effect of obesity on outcome in acute ischemic stroke patients with LVO, meaning better functional outcome, lower mortality, and lower risk of stroke progression for patients with higher BMI. As we found no interaction between BMI and EVT effect, all BMI classes may expect the same benefit from EVT.",2019,"Safety analysis showed that higher BMI was associated with lower risk of stroke progression (aOR 0.92, 95% CI 0.87-0.99).","['Acute Ischemic Stroke Patients', 'acute ischemic stroke patients with LVO', 'Of 366 patients, 160 (44%) were underweight or normal weight, 145 (40', 'stroke patients', 'acute ischemic stroke patients with large vessel -occlusion (LVO', 'patients with higher BMI', 'overweight, and 61 (17%) were obese']","['Body Mass Index', 'endovascular treatment (EVT', 'Endovascular Treatment']","['mortality', 'BMI and EVT effect on functional outcome, mortality, and other safety outcomes', 'risk of stroke progression', 'EVT effect']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",366.0,0.109043,"Safety analysis showed that higher BMI was associated with lower risk of stroke progression (aOR 0.92, 95% CI 0.87-0.99).","[{'ForeName': 'France Anne Victoire', 'Initials': 'FAV', 'LastName': 'Pirson', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands, fav.pirson@mumc.nl.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'Hinsenveld', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Staals', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bianca T A', 'Initials': 'BTA', 'LastName': 'de Greef', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan Albert', 'Initials': 'JA', 'LastName': 'Vos', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'Department of Neurology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000504744']
819,31338642,Promoting integrated care in prostate cancer through online prostate cancer-specific holistic needs assessment: a feasibility study in primary care.,"PURPOSE


This study assessed the feasibility of implementing a novel model of integrated prostate cancer care involving an online prostate cancer-specific holistic needs assessment (sHNA) and shared digital communication between patients and their healthcare professionals (HCPs). The sHNA produces a semi-automated care plan that is finalised in consultation between the patient and their practice nurse.
METHODS


Men living with and beyond prostate cancer were invited to participate in a 9-month non-randomised cluster controlled feasibility study. The intervention group was asked to complete the sHNA on three occasions. Data were collected using Patient Reported Outcome Measures (PROMs) at baseline, 10 and 24 weeks, and 9 months. Outcomes included recruitment, retention, acceptability, and engagement with the sHNA and PROMs.
RESULTS


Fourteen general practices (8 intervention and 6 control), and 41 men (29 intervention and 12 control) participated. Initial patient engagement with the sHNA was high, with all but one receiving practice nurse-led follow-up and an individualised care plan. The sHNA proved useful in identifying 'red flag' symptoms, and helping practice nurses decide when to seek further medical care for the patients. There was a high level of acceptability for patients and HCPs. However, integration of care did not occur as intended because of problems linking hospital and general practice IT systems.
CONCLUSION


While the study demonstrated the feasibility of implementing the sHNA, it did not meet the a priori progression criteria; as such, undertaking a definitive randomised controlled trial is not appropriate until the identified methodological and technical issues have been addressed.",2020,"The sHNA proved useful in identifying 'red flag' symptoms, and helping practice nurses decide when to seek further medical care for the patients.","['Fourteen general practices (8 intervention and 6 control), and 41 men (29 intervention and 12 control) participated', 'patients and their healthcare professionals (HCPs', 'Men living with and beyond prostate cancer']",['integrated prostate cancer care involving an online prostate cancer-specific holistic needs assessment (sHNA'],"['recruitment, retention, acceptability, and engagement with the sHNA and PROMs']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0558005', 'cui_str': 'Needs Assessment'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}]",14.0,0.0442125,"The sHNA proved useful in identifying 'red flag' symptoms, and helping practice nurses decide when to seek further medical care for the patients.","[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Clarke', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Roscoe', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Parashar', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Muthuswamy', 'Affiliation': 'Prostate Cancer UK Information Technology Consultant, London, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Nanton', 'Affiliation': 'University of Warwick, Coventry, UK. V.nanton@warwick.ac.uk.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04967-y']
820,30025502,"Microfinance and health interventions: Factors influencing loan repayment success with young men in Dar es Salaam, Tanzania.","Poverty is associated with numerous poor health outcomes. Youth unemployment in Tanzania is approximately 13.7%, and concentrates in urban areas. These youth lack relevant job skills and access to financial capital. Microfinance continues to be implemented globally to address poverty, and increasingly has been linked to health interventions. Men less frequently are recipients of microfinance loans. We offered microcredit to young men in an area of Dar es Salaam with high poverty as part of a randomised controlled-trial to assess the efficacy of a microfinance and health leadership intervention in preventing STI acquisition. We used mixed methods to understand predictors of successful loan repayment. Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment. Using a modified Poisson approach, our quantitative analysis showed that successful repayment was associated with business experience, education, increasing number of children, community of residence, percentage of network members trained in business, and repayment success of peer leaders. Our results suggest that enforcing group accountability and repayment rules, offering ongoing training, and using successful entrepreneurs as role models could increase repayment success in similar populations. These strategies could provide financial opportunity for men while minimising risk for microfinance institutions.",2019,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","['young men in an area of Dar es Salaam with high poverty', 'young men in Dar es Salaam, Tanzania']","['Microfinance and health interventions', 'microfinance and health leadership intervention']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",[],,0.0426746,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'School of International Service, American University, Washington DC, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Mwikoko', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deusdith', 'Initials': 'D', 'LastName': 'Kajuna', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leatherman', 'Affiliation': 'Department of Health Policy and Management, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}]",Global public health,['10.1080/17441692.2018.1501079']
821,30137218,Effect of Intentional Weight Loss on Mortality Biomarkers in Older Adults With Obesity.,"BACKGROUND


Observational research has identified several mortality biomarkers; however, their responsiveness to change is unknown. We tested whether the Healthy Aging Index (HAI) and other mortality biomarkers were responsive to intentional weight loss (WL), which is associated with lower mortality risk in recent meta-analyses.
METHODS


Older adults (70.3 ± 3.7 years) with obesity were randomized into a 6-month WL (n = 47) or weight stability (WS: ±5% baseline weight; n = 48) program. Baseline and 6-month HAI score (0-10) was calculated from component sum (each 0-2: systolic blood pressure, forced vital capacity [FVC], creatinine, fasting blood glucose [FBG], Montreal Cognitive Assessment), and gait speed, grip strength, Digit Symbol Substitution Test, FEV1, Interleukin-6, C-Reactive Protein, and Cystatin-C were assessed at baseline and 6 months.
RESULTS


Mean baseline HAI was 3.2 ± 1.6. By 6 months, WL participants lost 8.87 (95% CI: -10.40, -7.34) kg, whereas WS participants remained weight stable. WL group reduced HAI score (WL: -0.75 [95% CI: -1.11, -0.39] vs WS: -0.22 [95% CI: -0.60, 0.15]; p = .04), and components changing the most were FBG (WL: -3.89 [95% CI: -7.78, 0.00] mg/dL vs WS: 1.45 [95% CI: -2.61, 5.50] mg/dL; p = .047) and FVC (WL: 0.11 [95% CI: -0.01, 0.23] L vs WS: -0.05 [95% CI: -0.17, 0.08] L; p = .06). Among other biomarkers, only Cystatin-C significantly changed (WL: -2.53 [95% CI: -4.38, -0.68] ng/mL vs WS: 0.07 [95% CI: -1.85, 1.98] ng/mL; p = .04). Combining treatment groups, 1 kg WL was associated with a 0.07 (95% CI: 0.03, 0.12) HAI reduction (p < .01).
CONCLUSION


Intentional WL via caloric restriction reduced HAI score by 0.53 points, largely attributable to metabolic and pulmonary improvements.",2019,"WL group reduced HAI score (WL: -0.75 [95% CI: -1.11, -0.39] vs WS: -0.22 [95% CI: -0.60, 0.15]; p = .04), and components changing the most were FBG","['Methods\n\n\nOlder adults (70.3 ± 3.7 years) with obesity', 'Older Adults With Obesity']","['Intentional Weight Loss', 'FBG']","['Mortality Biomarkers', 'HAI score', 'systolic blood pressure, forced vital capacity [FVC], creatinine, fasting blood glucose [FBG], Montreal Cognitive Assessment), and gait speed, grip strength, Digit Symbol Substitution Test, FEV1, Interleukin-6, C-Reactive Protein, and Cystatin-C', 'HAI reduction', 'Baseline and 6-month HAI score', 'Healthy Aging Index (HAI) and other mortality biomarkers']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C3496286'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.244831,"WL group reduced HAI score (WL: -0.75 [95% CI: -1.11, -0.39] vs WS: -0.22 [95% CI: -0.60, 0.15]; p = .04), and components changing the most were FBG","[{'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Shaver', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kiel', 'Affiliation': 'Department of Scientific and Clinical Affairs, Medifast, Inc., Baltimore, Maryland.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School o f Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly192']
822,31668393,Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial.,"OBJECTIVE


Growth hormone (GH) stimulates lipolysis, but the underlying mechanisms remain incompletely understood. We examined the effect of GH on the expression of lipolytic regulators in adipose tissue (AT).
METHODS


In a randomized, placebo-controlled, cross-over study, nine men were examined after injection of 1) a GH bolus and 2) a GH-receptor antagonist (pegvisomant) followed by four AT biopsies. In a second study, eight men were examined in a 2 × 2 factorial design including GH infusion and 36-h fasting with AT biopsies obtained during a basal period and a hyperinsulinemic-euglycemic clamp. Expression of GH-signaling intermediates and lipolytic regulators were studied by PCR and western blotting. In addition, mechanistic experiments in mouse models and 3T3-L1 adipocytes were performed.
RESULTS


The GH bolus increased circulating free fatty acids (p < 0.0001) together with phosphorylation of signal transducer and activator of transcription 5 (STAT5) (p < 0.0001) and mRNA expression of the STAT5-dependent genes cytokine-inducible SH2-containing protein (CISH) and IGF-1 in AT. This was accompanied by suppressed mRNA expression of G0/G1 switch gene 2 (G0S2) (p = 0.007) and fat specific protein 27 (FSP27) (p = 0.002) and upregulation of phosphatase and tensin homolog (PTEN) mRNA expression (p = 0.03). Suppression of G0S2 was also observed in humans after GH infusion and fasting, as well as in GH transgene mice, and in vitro studies suggested MEK-PPARγ signaling to be involved.
CONCLUSIONS


GH-induced lipolysis in human subjects in vivo is linked to downregulation of G0S2 and FSP27 and upregulation of PTEN in AT. Mechanistically, in vitro data suggest that GH acts via MEK to suppress PPARγ-dependent transcription of G0S2. ClinicalTrials.govNCT02782221 and NCT01209429.",2019,The GH bolus increased circulating free fatty acids (p < 0.0001) together with phosphorylation of signal transducer and activator of transcription 5 (STAT5) (p < 0.0001) and mRNA expression of the STAT5-dependent genes cytokine-inducible SH2-containing protein (CISH) and IGF-1 in AT.,['human subjects'],"['placebo', 'GH bolus and 2) a GH-receptor antagonist (pegvisomant', 'GH', 'GH infusion and 36-h fasting with AT biopsies obtained during a basal period and a hyperinsulinemic-euglycemic clamp']","['circulating free fatty acids', 'mRNA expression of the STAT5-dependent genes cytokine-inducible SH2-containing protein (CISH) and IGF-1', 'signal transducer and activator of transcription 5 (STAT5', 'upregulation of phosphatase and tensin homolog (PTEN) mRNA expression', 'fat specific protein 27 (FSP27', 'suppressed mRNA expression of G0/G1 switch gene 2 (G0S2']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0913469', 'cui_str': 'pegvisomant'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0299250'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1121634', 'cui_str': 'STAT5 Transcription Factor'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C4522024', 'cui_str': 'Phosphatase (disposition)'}, {'cui': 'C0168424', 'cui_str': 'Tensins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0017373', 'cui_str': 'Genes, Switch'}]",,0.0669836,The GH bolus increased circulating free fatty acids (p < 0.0001) together with phosphorylation of signal transducer and activator of transcription 5 (STAT5) (p < 0.0001) and mRNA expression of the STAT5-dependent genes cytokine-inducible SH2-containing protein (CISH) and IGF-1 in AT.,"[{'ForeName': 'Astrid Johannesson', 'Initials': 'AJ', 'LastName': 'Hjelholt', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200 Aarhus N, Denmark. Electronic address: ajh@clin.au.dk.'}, {'ForeName': 'Kevin Y', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Heritage College of Osteopathic Medicine, Ohio University, 204 Grosvenor Hall, Athens, OH 45701, USA; The Diabetes Institute, Ohio University, Konneker Research Center 108, Athens, OH 45701, USA.'}, {'ForeName': 'Mai Christiansen', 'Initials': 'MC', 'LastName': 'Arlien-Søborg', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Steen Bønløkke', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark; Steno Diabetes Center Aarhus, Aarhus University Hospital, Hedeager 3, 2., 8200 Aarhus N, Denmark.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Kopchick', 'Affiliation': 'Heritage College of Osteopathic Medicine, Ohio University, 204 Grosvenor Hall, Athens, OH 45701, USA; The Edison Biotechnology Institute, Ohio University, Konneker Research Center, 172 Water Tower Dr., Athens, OH 45701, USA.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Puri', 'Affiliation': 'Heritage College of Osteopathic Medicine, Ohio University, 204 Grosvenor Hall, Athens, OH 45701, USA; The Diabetes Institute, Ohio University, Konneker Research Center 108, Athens, OH 45701, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Hedeager 3, 2., 8200 Aarhus N, Denmark; Department of Clinical Pharmacology, Aarhus University Hospital, Wilh. Meyers Allé 4, 8000 Aarhus C, Denmark; Department of Biomedicine, Aarhus University, Vennelyst Boulevard 4, 8000 Aarhus C, Denmark.'}, {'ForeName': 'Jens Otto L', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200 Aarhus N, Denmark.'}]",Molecular metabolism,['10.1016/j.molmet.2019.08.013']
823,31982203,The Look After Yourself (LAY) intervention to improve self-management in stroke survivors: Results from a quasi-experimental study.,"OBJECTIVE


To test the efficacy of a self-management intervention for stroke survivors vs. usual care.
METHODS


Using a quasi-experimental study, participants were recruited from three public Italian hospitals. Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge. Mixed models with a propensity score were used between experimental group (EG) and control group (CG). Logistic models were used to compare the use of health services.
RESULTS


Eighty-two stroke survivors were enrolled in the EG and 103 in the CG. Self-efficacy in self-management improved in the EG compared to the CG during hospitalization. Improvements from baseline to discharge were found in the EG in the mental component of SF-12 and in MBI. The EG were 8.9 times more likely to contact general practitioners after discharge and 2.9 times to do regular exercise than CG. Notably, EG with higher education benefitted more from the intervention.
CONCLUSION


The intervention was efficacious in improving self-efficacy, mental health and activities of daily living.
PRACTICE IMPLICATIONS


Structured educational interventions based on problem-solving and individual goal setting may improve self-management skills in stroke survivors.",2020,"Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge.","['stroke survivors vs. usual care', 'participants were recruited from three public Italian hospitals', 'stroke survivors', 'Eighty-two stroke survivors']","['Structured educational interventions', 'Yourself (LAY) intervention', 'self-management intervention']","['self-efficacy, mental health and activities of daily living', 'Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C2607857'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0274552,"Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge.","[{'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Messina', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy. Electronic address: laura.dallolio@unibo.it.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Fugazzaro', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rucci', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Iommi', 'Affiliation': 'Advanced School for Health Policy-Specialisation School for Public Administration, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bardelli', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Department of Surgery, Medicine, Dentistry and Morphological Sciences-University of Modena and Reggio-Emilia, Modena, Italy; Scientific Directorate-Local Health Authority-IRCCS of Reggio-Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Denti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Monia Allisen', 'Initials': 'MA', 'LastName': 'Accogli', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Cavalli', 'Affiliation': 'University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Pagliacci', 'Affiliation': 'Department of Community Health Care Agency USL Tuscany, Northwest, Pisa, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Fantini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Taricco', 'Affiliation': 'University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Patient education and counseling,['10.1016/j.pec.2020.01.004']
824,29236550,Effects of e-Cigarette Advertisements on Adolescents' Perceptions of Cigarettes.,"This study examined the effect of exposure to ""cigalike"" (products resembling cigarettes) e-cigarette advertisements on adolescents' perceptions of cigarettes. A nationally representative sample of 802 adolescents (13-17 years old) was randomly assigned to watch three e-cigarette or three control advertisements. Never-smokers who saw the e-cigarette advertisements (n = 352) reported significantly lower perceived risks of smoking than those in the control condition (n = 320). Ever-smokers (n = 130) did not show significant differences across the conditions. In subgroup analyses, current smokers (reported smoking in the past 30 days, n = 31) in the e-cigarette condition reported significantly lower perceived benefits of smoking than those in the control condition. E-cigarette advertisements can affect adolescents' perceptions of cigarettes. Many advertisements, especially the ones promoting ""cigalikes,"" depict e-cigarettes as being similar to cigarettes (e.g., look, flavor) but also as a solution for cigarettes' shortcomings (e.g., bad smell). While the advertisements include messages about problems posed by cigarettes, proposing e-cigarettes as a solution may decrease the perceived risks of smoking among never-smokers. It may also not be clear to adolescents whether advertisements are for cigarettes or e-cigarettes. Regulating e-cigarette advertisements to minimize adolescents' exposure may prevent potential harmful effects on never-smokers' perception of smoking.",2019,Never-smokers who saw the e-cigarette advertisements (n = 352) reported significantly lower perceived risks of smoking than those in the control condition (n = 320).,"[""adolescents' perceptions of cigarettes"", 'A nationally representative sample of 802 adolescents (13-17\xa0years old', ""Adolescents' Perceptions of Cigarettes""]","['e-cigarette advertisements', 'E-cigarette advertisements', 'e-Cigarette Advertisements', 'cigalike"" (products resembling cigarettes']","['benefits of smoking', 'risks of smoking', 'perceived risks of smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",802.0,0.019896,Never-smokers who saw the e-cigarette advertisements (n = 352) reported significantly lower perceived risks of smoking than those in the control condition (n = 320).,"[{'ForeName': 'Minji', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'a Center for Tobacco Control Research and Education , University of California.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'b Division of Health Promotion and Behavior, School of Public Health , Georgia State University.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Halpern-Felsher', 'Affiliation': 'c Division of Adolescent Medicine, Department of Pediatrics , Stanford University.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'd Center for Tobacco Control Research and Education and Division of General Internal Medicine, Department of Medicine , University of California.'}]",Health communication,['10.1080/10410236.2017.1407230']
825,29236554,Just a Spoonful of Sugar Helps the Messages Go Down: Using Stories and Vicarious Self-Affirmation to Reduce e-Cigarette Use.,"While prior research has demonstrated the benefits of self-affirming individuals prior to exposing them to potentially threatening health messages, the current study assesses the feasibility of inducing self-affirmation vicariously through the success of a character in a narrative. In Study 1, college-age participants who regularly use e-cigarettes (N = 225) were randomly assigned to read one of two versions of a story depicting a college student of their own gender. The versions were identical except in the vicarious self-affirmation (VSA) condition, the main character achieves success (i.e., honored with a prestigious award) before being confronted by a friend about the dangers associated with their e-cigarette use; whereas in the vicarious control condition, the achievement is mentioned after the risk information. Results of the posttest and 10-day follow-up demonstrated that VSA reduced messages derogation, while increasing self-appraisal and perceived risk. The effect of VSA on e-cigarette outcomes was moderated by frequency of use, with heavier users benefiting the most. Study 2 (N = 152) confirmed that traditional value affirmation works with our stimuli on a comparable population.",2019,"Results of the posttest and 10-day follow-up demonstrated that VSA reduced messages derogation, while increasing self-appraisal and perceived risk.",['college-age participants who regularly use e-cigarettes (N\xa0=\xa0225'],['VSA'],"['self-appraisal and perceived risk', 'e-cigarette outcomes']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}]",[],"[{'cui': 'C2936632', 'cui_str': 'Self-Appraisal'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]",225.0,0.0178154,"Results of the posttest and 10-day follow-up demonstrated that VSA reduced messages derogation, while increasing self-appraisal and perceived risk.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Walter', 'Affiliation': 'a Annenberg School for Communication and Journalism , University of Southern California.'}, {'ForeName': 'Stefanie Z', 'Initials': 'SZ', 'LastName': 'Demetriades', 'Affiliation': 'a Annenberg School for Communication and Journalism , University of Southern California.'}, {'ForeName': 'Sheila T', 'Initials': 'ST', 'LastName': 'Murphy', 'Affiliation': 'a Annenberg School for Communication and Journalism , University of Southern California.'}]",Health communication,['10.1080/10410236.2017.1407275']
826,28295312,"Young adult outcomes in the follow-up of the multimodal treatment study of attention-deficit/hyperactivity disorder: symptom persistence, source discrepancy, and height suppression.","BACKGROUND


The Multimodal Treatment Study (MTA) began as a 14-month randomized clinical trial of behavioral and pharmacological treatments of 579 children (7-10 years of age) diagnosed with attention-deficit/hyperactivity disorder (ADHD)-combined type. It transitioned into an observational long-term follow-up of 515 cases consented for continuation and 289 classmates (258 without ADHD) added as a local normative comparison group (LNCG), with assessments 2-16 years after baseline.
METHODS


Primary (symptom severity) and secondary (adult height) outcomes in adulthood were specified. Treatment was monitored to age 18, and naturalistic subgroups were formed based on three patterns of long-term use of stimulant medication (Consistent, Inconsistent, and Negligible). For the follow-up, hypothesis-generating analyses were performed on outcomes in early adulthood (at 25 years of age). Planned comparisons were used to estimate ADHD-LNCG differences reflecting persistence of symptoms and naturalistic subgroup differences reflecting benefit (symptom reduction) and cost (height suppression) associated with extended use of medication.
RESULTS


For ratings of symptom severity, the ADHD-LNCG comparison was statistically significant for the parent/self-report average (0.51 ± 0.04, p < .0001, d = 1.11), documenting symptom persistence, and for the parent/self-report difference (0.21 ± 0.04, p < .0001, d = .60), documenting source discrepancy, but the comparisons of naturalistic subgroups reflecting medication effects were not significant. For adult height, the ADHD group was 1.29 ± 0.55 cm shorter than the LNCG (p < .01, d = .21), and the comparisons of the naturalistic subgroups were significant: the treated group with the Consistent or Inconsistent pattern was 2.55 ± 0.73 cm shorter than the subgroup with the Negligible pattern (p < .0005, d = .42), and within the treated group, the subgroup with the Consistent pattern was 2.36 ± 1.13 cm shorter than the subgroup with the Inconsistent pattern (p < .04, d = .38).
CONCLUSIONS


In the MTA follow-up into adulthood, the ADHD group showed symptom persistence compared to local norms from the LNCG. Within naturalistic subgroups of ADHD cases, extended use of medication was associated with suppression of adult height but not with reduction of symptom severity.",2017,"For ratings of symptom severity, the ADHD-LNCG comparison was statistically significant for the parent/self-report average (0.51 ± 0.04, p < .0001,","['515 cases consented for continuation and 289 classmates (258 without ADHD) added as a', '579 children (7-10\xa0years of age) diagnosed with attention-deficit/hyperactivity disorder (ADHD)-combined type']",['local normative comparison group (LNCG'],['symptom persistence'],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}]",579.0,0.0299926,"For ratings of symptom severity, the ADHD-LNCG comparison was statistically significant for the parent/self-report average (0.51 ± 0.04, p < .0001,","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Swanson', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Irvine, CA, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, Nisonger Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Brooke S G', 'Initials': 'BSG', 'LastName': 'Molina', 'Affiliation': 'Departments of Psychiatry and Psychology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Lily T', 'Initials': 'LT', 'LastName': 'Hechtman', 'Affiliation': ""Division of Child Psychiatry, McGill University, Montreal Children's Hospital, Montreal, QC, Canada.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hinshaw', 'Affiliation': 'Department of Psychology, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Howard B', 'Initials': 'HB', 'LastName': 'Abikoff', 'Affiliation': 'Child Study Center at New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Irvine, CA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Owens', 'Affiliation': 'Institute of Human Development, University of California, Berkeley, CA, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Nichols', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Department of Psychology, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Laurence L', 'Initials': 'LL', 'LastName': 'Greenhill', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Hoza', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Department of Psychiatry, Mount Sinai Medical School, New York, NY, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Jensen', 'Affiliation': 'Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wigal', 'Affiliation': 'Avida, Inc., Newport Beach, CA, USA.'}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Lakes', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Irvine, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Waxmonsky', 'Affiliation': 'Penn State University, College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lerner', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Irvine, CA, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Etcovitch', 'Affiliation': ""Montreal Children's Hospital, Montreal, QC, Canada.""}, {'ForeName': 'Desiree W', 'Initials': 'DW', 'LastName': 'Murray', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Muenke', 'Affiliation': 'National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Acosta', 'Affiliation': 'National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arcos-Burgos', 'Affiliation': 'Institute of Translational Medicine, Universidad del Rosario, Bogata, Colombia.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Department of Psychology, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kraemer', 'Affiliation': 'Department of Psychiatry, Stanford University, Stanford, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.12684']
827,31983494,Oral Ondansetron to Reduce Vomiting in Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia: A Randomized Controlled Trial.,"STUDY OBJECTIVE


Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo.
METHODS


This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups.
RESULTS


We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group.
CONCLUSION


Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.",2020,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"['442 participants and 436 were included for analysis', 'Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide', 'single tertiary care pediatric emergency department', 'Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia']","['fentanyl and inhaled nitrous oxide', 'oral ondansetron or placebo', 'ondansetron', 'Oral ondansetron', 'placebo', 'oral ondansetron', 'Oral Ondansetron', 'inhaled nitrous oxide']","['Vomiting', 'incidence of vomiting', 'vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups', 'early vomiting associated with procedural sedation', 'vomiting', 'adverse events', 'early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",442.0,0.574584,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fauteux-Lamarre', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Quinn', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Legge', 'Affiliation': ""Department of Pharmacy, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Palmer', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.019']
828,32406431,Adjunctive vitamin A and D during pulmonary tuberculosis treatment: a randomized controlled trial with a 2 × 2 factorial design.,"BACKGROUND AND OBJECTIVE


Vitamin A and D have immunoregulatory effects and may improve the response to pulmonary tuberculosis treatment. The interaction of vitamin A and D on pulmonary tuberculosis treatment has not been studied. The objective is to investigate the effects of adjunctive supplementation of vitamin A, D and their interaction on the outcome of pulmonary tuberculosis treatment, primarily time to sputum smear conversion.
METHODS


We conducted a randomized controlled trial with a 2 × 2 factorial design in Qingdao, China. Eight hundred patients were enrolled to receive standard pulmonary tuberculosis therapy alone (control), or together with vitamin A (2000 IU d -1 ), or vitamin D (400 IU d -1 ) or a combination of vitamin A (2000 IU d -1 ) and D (400 IU d -1 ) during the intensive-phase of pulmonary tuberculosis treatment.
RESULTS


761 patients were included in the tuberculosis symptom analysis; 521 patients with positive baseline sputum smear results were included in the sputum smear analysis. The allocation to vitamin A or D did not significantly influence the time to sputum smear conversion [vitamin A: adjusted hazard ratio: 1.021, 95% CI: (0.821, 1.271); vitamin D: adjusted hazard ratio: 0.949, 95% CI: (0.760, 1.185)]. No significant interaction was observed between vitamin A and D supplementation (p = 0.660). Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
CONCLUSIONS


Adjunctive supplementation of vitamin A and/or D did not improve the time to smear conversion in pulmonary tuberculosis patients. However vitamin D supplementation significantly improved tuberculosis symptoms during the first month of pulmonary tuberculosis treatment.",2020,"Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
","['761 patients were included in the tuberculosis symptom analysis; 521 patients with positive baseline sputum smear results were included in the sputum smear analysis', 'pulmonary tuberculosis patients', 'Eight hundred patients were enrolled to receive', '2 × 2 factorial design in Qingdao, China']","['Vitamin D supplementation', 'standard pulmonary tuberculosis therapy alone (control), or together with vitamin A (2000 IU d-1), or vitamin D (400 IU d-1) or a combination of vitamin A', 'vitamin A', 'Adjunctive vitamin A and D', 'vitamin D supplementation']","['time to smear conversion', 'tuberculosis symptoms', 'time to sputum smear conversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}]",800.0,0.539665,"Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
","[{'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong 266021, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Qiuzhen', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shanliang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': ''}]",Food & function,['10.1039/c9fo02751c']
829,31958985,Inter- and Intra-Rater Reliability of Laryngeal Sensation Testing with the Touch Method During Flexible Endoscopic Evaluations of Swallowing.,"OBJECTIVES


Sensation is an integral component of laryngeal control for breathing, swallowing, and vocalization. Laryngeal sensation is assessed by elicitation of the laryngeal adductor reflex (LAR), a brainstem-mediated adduction of the true vocal folds. During Flexible Endoscopic Evaluations of Swallowing (FEES), the touch method can be used to elicit the LAR to judge laryngeal sensation. Despite the prevalence of this method in clinical practice and research, prior studies have yet to examine inter- and intra-rater reliability.
METHODS


Four speech-language pathologists rated 125 randomized video clips for the presence, absence, or inability to rate the LAR. Fifty percent of video clips were re-randomized and re-rated 1 week later. Raters then created guidelines and participated in formal consensus training sessions on a separate set of videos. Ratings were repeated post-training.
RESULTS


Overall inter-rater reliability was fair (κ = 0.22) prior to training. Pre-training intra-rater reliability ranged from fair (κ = 0.35) to almost perfect (κ = 0.89). Inter-rater reliability significantly improved after training (κ = 0.42,  P  < .001), though agreement did not reach prespecified acceptable levels (κ ≥ 0.80). Post-training intra-rater reliability ranged from moderate (κ = 0.49) to almost perfect (κ = 0.85).
CONCLUSION


Adequate inter-rater reliability was not achieved when rating isolated attempts to elicit the LAR. Acceptable within-rater reliability was observed in some raters 1 week after initial ratings, suggesting that ratings may remain consistent within raters over a short period of time. Limitations and considerations for future research using the touch method are discussed.",2020,"Inter-rater reliability significantly improved after training (κ = 0.42,  P  < .001), though agreement did not reach prespecified acceptable levels (κ ≥ 0.80).",['Four speech-language pathologists rated 125 randomized'],"['Flexible Endoscopic Evaluations of Swallowing (FEES', 'video clips']","['Inter-rater reliability', 'Laryngeal sensation', 'Adequate inter-rater reliability', 'Acceptable within-rater reliability']","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",125.0,0.0185579,"Inter-rater reliability significantly improved after training (κ = 0.42,  P  < .001), though agreement did not reach prespecified acceptable levels (κ ≥ 0.80).","[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Borders', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': ""O'Dea"", 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'McNally', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Norberg', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Merertu', 'Initials': 'M', 'LastName': 'Kitila', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Communication Sciences and Disorders, MGH-Institute of Health Professions, Boston, MA, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Pisegna', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489419901145']
830,31964579,"Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.","OBJECTIVES


To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression.
METHODS


Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status.
RESULTS


Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients.
CONCLUSION


The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms.
PRACTICE IMPLICATIONS


The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients.",2020,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","['Patients (N\u202f=\u202f614', 'rural heart failure (HF) patients', 'patients with depressive symptoms', 'patients with and without depression', 'patients with heart failure']","['face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS', 'usual care (UC', 'educational intervention']","['HF knowledge', 'HF knowledge and self-care', 'health-related quality of life (HRQOL', 'heart failure knowledge, self-care behaviors, and health-related quality of life', 'self-care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",614.0,0.0257365,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: bhwang@snu.ac.kr.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.007']
831,31965072,"Liraglutide improves memory in obese patients with prediabetes or early type 2 diabetes: a randomized, controlled study.","BACKGROUND/OBJECTIVES


Diabetic subjects are at increased risk of subtle cognitive impairment since the disease early stages and of dementia later in life. In animal models, glucagon-like peptide-1 receptor agonizts (GLP1-RAs) have been shown to exert neuroprotective effects, expecially in the memory domain. We assessed whether treatment with a GLP1-RA might affect cognitive functions in type 2 diabetic subjects independently on the weight loss it might induce.
SUBJECTS/METHODS


Forty metformin-treated obese subjects with prediabetes or newly diagnosed type 2 diabetes mellitus, received liraglutide (1.8 mg/d) (n = 20) or lifestyle counseling (dietary intervention and exercise training) (n = 20) until achieving a modest and comparable weight loss (-7% of initial body weight).
INTERVENTIONS/METHODS


A detailed neuropsychological assessment before and after weight loss was completed in 16 patients per arm, who were administered a total of seven psychological tests, thus assessing three composite domain z-scores for attention, memory, and executive control.
RESULTS


After comparable weight loss and superimposable glycemic control and insulin sensitivity, a significant increase in short term memory (mean Digit Span Z score from -0.06 to 0.80, p = 0.024) and memory composite z-score (mean memory z-score from -0.67 to 0.032, p = 0.0065) was observed in the liraglutide exposed subjects (between group p = 0.041 and p = 0.033, respectively).
CONCLUSIONS


Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.",2020,"Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.","['obese patients with prediabetes or early type 2 diabetes', 'type 2 diabetic subjects', 'Forty metformin-treated obese subjects with prediabetes or newly diagnosed type 2 diabetes mellitus', 'diabetic patients', 'Diabetic subjects']","['lifestyle counseling (dietary intervention and exercise training', 'liraglutide', 'Liraglutide', 'GLP1-RA']","['weight loss and superimposable glycemic control and insulin sensitivity', 'weight loss', 'cognitive functions', 'short term memory (mean Digit Span Z score', 'memory composite z-score']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.0226642,"Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vadini', 'Affiliation': 'Psychoinfectivology Service, Pescara General Hospital, Pescara, Italy.'}, {'ForeName': 'Paola G', 'Initials': 'PG', 'LastName': 'Simeone', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Boccatonda', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Guagnano', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Liani', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Tripaldi', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea, Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cipollone', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Santilli', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy. francesca.santilli@unich.it.'}]",International journal of obesity (2005),['10.1038/s41366-020-0535-5']
832,31094782,"Effect of Apneic Oxygenation on Tracheal Oxygen Levels, Tracheal Pressure, and Carbon Dioxide Accumulation: A Randomized, Controlled Trial of Buccal Oxygen Administration.","BACKGROUND


Apneic oxygenation via the oral route using a buccal device extends the safe apnea time in most but not all obese patients. Apneic oxygenation techniques are most effective when tracheal oxygen concentrations are maintained >90%. It remains unclear whether buccal oxygen administration consistently achieves this goal and whether significant risks of hypercarbia or barotrauma exist.
METHODS


We conducted a randomized trial of buccal or sham oxygenation in healthy, nonobese patients (n = 20), using prolonged laryngoscopy to maintain apnea with a patent airway until arterial oxygen saturation (SpO2) dropped <95% or 750 seconds elapsed. Tracheal oxygen concentration, tracheal pressure, and transcutaneous carbon dioxide (CO2) were measured throughout. The primary outcome was maintenance of a tracheal oxygen concentration >90% during apnea.
RESULTS


Buccal patients were more likely to achieve the primary outcome (P < .0001), had higher tracheal oxygen concentrations throughout apnea (mean difference, 65.9%; 95% confidence interval [CI], 62.6%-69.3%; P < .0001), and had a prolonged median (interquartile range) apnea time with SpO2 >94%; 750 seconds (750-750 seconds) vs 447 seconds (405-525 seconds); P < .001. One patient desaturated to SpO2 <95% despite 100% tracheal oxygen. Mean tracheal pressures were low in the buccal (0.21 cm·H2O; SD = 0.39) and sham (0.56 cm·H2O; SD = 1.25) arms; mean difference, -0.35 cm·H2O; 95% CI, 1.22-0.53; P = .41. CO2 accumulation during early apnea before any study end points were reached was linear and marginally faster in the buccal arm (3.16 vs 2.82 mm Hg/min; mean difference, 0.34; 95% CI, 0.30-0.38; P < .001). Prolonged apnea in the buccal arm revealed nonlinear CO2 accumulation that declined over time and averaged 2.22 mm Hg/min (95% CI, 2.21-2.23).
CONCLUSIONS


Buccal oxygen administration reliably maintains high tracheal oxygen concentrations, but early arterial desaturation can still occur through mechanisms other than device failure. Whereas the risk of hypercarbia is similar to that observed with other approaches, the risk of barotrauma is negligible. Continuous measurement of advanced physiological parameters is feasible in an apneic oxygenation trial and can assist with device evaluation.",2019,"RESULTS


Buccal patients were more likely to achieve the primary outcome (P < .0001), had higher tracheal oxygen concentrations throughout apnea (mean difference, 65.9%; 95% confidence interval [CI], 62.6%-69.3%; P < .0001), and had a prolonged median (interquartile range) apnea time with SpO2 >94%; 750 seconds (750-750 seconds) vs 447 seconds (405-525 seconds); P < .001.","['obese patients', 'healthy, nonobese patients (n = 20), using prolonged laryngoscopy to maintain apnea with a patent airway until arterial oxygen saturation (SpO2) dropped <95% or 750 seconds elapsed']","['Apneic Oxygenation', 'buccal or sham oxygenation']","['safe apnea time', 'CO2 accumulation', 'Tracheal Oxygen Levels, Tracheal Pressure, and Carbon Dioxide Accumulation', 'tracheal oxygen concentrations', 'Prolonged apnea', 'Tracheal oxygen concentration, tracheal pressure, and transcutaneous carbon dioxide (CO2', 'Mean tracheal pressures', 'nonlinear CO2 accumulation', 'tracheal oxygen concentrations throughout apnea', 'prolonged median (interquartile range) apnea time', 'maintenance of a tracheal oxygen concentration']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration (observable entity)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.481714,"RESULTS


Buccal patients were more likely to achieve the primary outcome (P < .0001), had higher tracheal oxygen concentrations throughout apnea (mean difference, 65.9%; 95% confidence interval [CI], 62.6%-69.3%; P < .0001), and had a prolonged median (interquartile range) apnea time with SpO2 >94%; 750 seconds (750-750 seconds) vs 447 seconds (405-525 seconds); P < .001.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Toner', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Douglas', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Bailey', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Avis', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Arani V', 'Initials': 'AV', 'LastName': 'Pillai', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Heard', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003810']
833,31094793,Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile.,"BACKGROUND


The transversus abdominis plane (TAP) block has become a common regional anesthesia technique for pain management in a wide variety of abdominal procedures. Evidence to support any particular local anesthetic regimen as well as pharmacokinetic and systemic toxicity risks of TAP block remain insufficiently studied in children. The aim of this study was to compare the analgesic effects and investigate pharmacokinetic profile of levobupivacaine after ultrasound-guided TAP block using a low volume/high concentration (LVHC) or a high volume/low concentration (HVLC) solution in children.
METHODS


This prospective randomized study included children scheduled for day-case inguinal surgery. Children were randomized to receive TAP block using 0.4 mg·kg levobupivacaine as either HVLC (0.2 mL·kg of 0.2% levobupivacaine) or LVHC (0.1 mL·kg of 0.4% levobupivacaine). The primary outcome was the number of children who required opioid rescue analgesia postoperatively. Pharmacokinetic profile study of levobupivacaine was also performed.
RESULTS


Seventy patients were equally randomized, and 65 were included in the final analysis. Seventy-one percent of patients did not require any postoperative opioid analgesia. The number of patients who received rescue analgesia was 12 (35%) in the LVHC group and 7 (23%) in the HVLC group (relative risk, 0.64; 95% confidence interval [CI], 0.29-1.42; P = .26). Mean pain scores (FLACC [faces, legs, activity, cry, and consolability]) at postanesthesia care unit discharge did not differ between LVHC and HVLC groups, respectively, 0.39 ± 0.86 and 1 ± 1.71 with mean group difference -0.60 (95% CI, -1.27 to 0.06; P = .08). The pharmacokinetic profile of levobupivacaine was comparable in the 2 groups: the mean total and free levobupivacaine peak concentrations were 379 ± 248 and 3.95 ± 3.16 ng·mL, respectively, occurring 22.5 ± 11 minutes after injection. The highest total and free levobupivacaine concentrations collected, respectively, 1360 and 15.1 ng·mL, remained far below theoretical toxic thresholds.
CONCLUSIONS


In children, quality of postoperative pain control provided by TAP block using levobupivacaine 0.4 mg·kg administered as either HVLC or LVHC did not differ and was associated with a very low risk of local anesthetic systemic toxicity.",2019,The pharmacokinetic profile of levobupivacaine was comparable in the 2 groups:,"['children', 'children scheduled for day-case inguinal surgery', 'Children', 'Seventy patients were equally randomized, and 65 were included in the final analysis']","['HVLC or LVHC', 'levobupivacaine', 'LVHC', 'transversus abdominis plane (TAP) block', 'TAP block using 0.4 mg·kg levobupivacaine as either HVLC (0.2 mL·kg of 0.2% levobupivacaine) or LVHC (0.1 mL·kg of 0.4% levobupivacaine', 'HVLC']","['local anesthetic systemic toxicity', 'Mean pain scores (FLACC [faces, legs, activity, cry, and consolability]) at postanesthesia care unit discharge', 'rescue analgesia', 'number of children who required opioid rescue analgesia postoperatively', 'highest total and free levobupivacaine concentrations', 'analgesic effects', 'postoperative opioid analgesia', 'mean total and free levobupivacaine peak concentrations', 'Efficacy and Safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.286037,The pharmacokinetic profile of levobupivacaine was comparable in the 2 groups:,"[{'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Sola', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier University, Montpellier, France.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Menacé', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier, France.'}, {'ForeName': 'Anne-Charlotte', 'Initials': 'AC', 'LastName': 'Saour', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier University, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Raux', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier University, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mathieu', 'Affiliation': 'Department of Medical Pharmacology and Toxicology, Toxicology Laboratory, Montpellier University Hospital, UMR 5569 Hydrosciences Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Inserm Unit 1051 INM, Montpellier University, Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dadure', 'Affiliation': 'From the Pediatric Anesthesia Unit, Department of Anesthesia and Critical Care Medicine, Lapeyronie University Hospital, Montpellier University, Montpellier, France.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003736']
834,31094803,Effect of Intravenous Dexamethasone on the Regression of Isobaric Bupivacaine Spinal Anesthesia: A Randomized Controlled Trial.,"The effect of intravenous dexamethasone on the regression of sensory and motor block after isobaric bupivacaine spinal anesthesia is unknown. We conducted a prospective, double-blind, randomized controlled trial on 60 patients who received intravenously either placebo (group P) or 8-mg dexamethasone (group D) during the intrathecal injection of 12-mg isobaric bupivacaine 0.5%. Primary outcome was the time from bupivacaine injection to regression of 2 dermatomes in relation to the highest dermatome blocked by the spinal local anesthetic. Time to 2-dermatome regression was 85 minutes (74-96 minutes) in group P versus 87 minutes (76-98 minutes) in group D (P = .79).",2019,Time to 2-dermatome regression was 85 minutes (74-96 minutes) in group P versus 87 minutes (76-98 minutes) in group D (P = .79).,"['Isobaric Bupivacaine Spinal Anesthesia', '60 patients who received intravenously either']","['placebo', '8-mg dexamethasone', 'bupivacaine', 'Intravenous Dexamethasone', 'bupivacaine spinal anesthesia', 'dexamethasone']",['time from bupivacaine injection to regression of 2 dermatomes in relation to the highest dermatome blocked by the spinal local anesthetic'],"[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4060211', 'cui_str': 'Bupivacaine Injection [Sensorcaine]'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0392338', 'cui_str': 'Dermatome (body structure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]",60.0,0.437067,Time to 2-dermatome regression was 85 minutes (74-96 minutes) in group P versus 87 minutes (76-98 minutes) in group D (P = .79).,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Guay', 'Affiliation': ""From the Département d'anesthésiologie, Centre hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montréal, Québec, Canada.""}, {'ForeName': 'Stephan R', 'Initials': 'SR', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Robin', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003670']
835,31094804,Continuous Popliteal-Sciatic Blocks for Postoperative Analgesia: Traditional Proximal Catheter Insertion Superficial to the Paraneural Sheath Versus a New Distal Insertion Site Deep to the Paraneural Sheath.,"We tested the hypothesis that during a continuous popliteal-sciatic nerve block, postoperative analgesia is improved with the catheter insertion point ""deep"" to the paraneural sheath immediately distal to the bifurcation between the tibial and common peroneal branches, compared with the traditional approach ""superficial"" to the paraneural sheath proximal to the bifurcation. The needle tip location was determined to be accurately located with a fluid bolus visualized with ultrasound; however, catheters were subsequently inserted without a similar fluid injection and visualization protocol (visualized air injection was permitted and usually implemented, but not required per protocol). The average pain (0-10 scale) the morning after surgery for subjects with a catheter inserted at the proximal subparaneural location (n = 31) was a median (interquartile) of 1.5 (0.0-3.5) vs 1.5 (0.0-4.0) for subjects with a catheter inserted at the distal supraparaneural location (n = 32; P = .927). Secondary outcomes were similarly negative.",2019,The average pain (0-10 scale) the morning after surgery for subjects with a catheter inserted at the proximal subparaneural location (n = 31) was a median (interquartile) of 1.5 (0.0-3.5) vs 1.5 (0.0-4.0) for subjects with a catheter inserted at the distal supraparaneural location (n = 32;,[],[],['average pain'],[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.047019,The average pain (0-10 scale) the morning after surgery for subjects with a catheter inserted at the proximal subparaneural location (n = 31) was a median (interquartile) of 1.5 (0.0-3.5) vs 1.5 (0.0-4.0) for subjects with a catheter inserted at the distal supraparaneural location (n = 32;,"[{'ForeName': 'Jacklynn F', 'Initials': 'JF', 'LastName': 'Sztain', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Monahan', 'Affiliation': 'Department of Anesthesiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Khatibi', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Madison', 'Affiliation': 'Department of Anesthesiology, Stanford University, Stanford, California.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Bellars', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Gabriel', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}, {'ForeName': 'Sonya S', 'Initials': 'SS', 'LastName': 'Ahmed', 'Affiliation': 'Department of Orthopedics, University of California, San Diego, California.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Schwartz', 'Affiliation': 'Department of Orthopedics, University of California, San Diego, California.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Kent', 'Affiliation': 'Department of Orthopedics, University of California, San Diego, California.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Padwal', 'Affiliation': 'School of Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'From the Department of Anesthesiology, University of California, San Diego, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003693']
836,31413163,Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial.,"This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multidisease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome ""COPD exacerbation days per patient per year"" was assessed using intention-to-treat analyses.No significant difference was observed in the number of COPD exacerbation days per patient per year (self-management: median 9.6 (interquartile range (IQR) 0.7-31.1); UC: median 15.6 (IQR 3.0-40.3); incidence rate ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8-10.1) days; UC: median 9.5 (IQR 7.0-15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42; 1.35); p=0.348), but a lower probability of ≥1 for respiratory-related hospitalisation compared to UC (relative risk 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); relative risk 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.",2019,"No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); RR 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.","['COPD patients with comorbidities, trained in using patient-tailored multi-disease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (GOLD II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression', 'patients with COPD and comorbidities']",['patient-tailored self-management intervention (n=102) or UC'],"['shorter duration per COPD exacerbation', 'Daily symptom diaries', 'number of COPD exacerbation', 'mortality', 'total number of respiratory hospitalisations', 'duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation', 'Incidence Rate Ratio (IRR) 0.87', 'cause hospitalisations', 'COPD exacerbation days/patient/year']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0235874', 'cui_str': 'Disease Exacerbation'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.252026,"No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); RR 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Lenferink', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands a.lenferink@mst.nl.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Paul D L P M', 'Initials': 'PDLPM', 'LastName': 'van der Valk', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cafarella', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'van Veen', 'Affiliation': 'Dept of Pulmonary Medicine, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Dept of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Catharina G M', 'Initials': 'CGM', 'LastName': 'Groothuis-Oudshoorn', 'Affiliation': 'Dept of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Morton G', 'Initials': 'MG', 'LastName': 'Burt', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'Dept of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Frith', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Tanja W', 'Initials': 'TW', 'LastName': 'Effing', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",The European respiratory journal,['10.1183/13993003.02134-2018']
837,31197389,Arthroscopic suture-tape internal bracing is safe as arthroscopic modified Broström repair in the treatment of chronic ankle instability.,"PURPOSE


The aim of the study was to compare the intermediate-term clinical outcomes between lateral ligaments augmentation using suture-tape and modified Broström repair in a selected cohort of patients. The hypothesis of the presented study is that suture-tape augmentation technique has comparable clinical and radiological outcomes with arthroscopic Broström repair technique.
METHODS


Sixty-one consecutive patients with chronic ankle instability were operated between 2012 and 2016 randomized to 2 groups. First group was composed of 31 patients whom were operated using an arthroscopic Broström repair technique (ABR) and second group was composed of 30 Patients whom were operated using arthroscopic lateral ligaments augmentation using suture-tape internal bracing (AST). At the end of total follow-up time, all patients were evaluated clinically using the Foot and Ankle Outcome Score (FAOS) and Foot and Ankle Ability Measure (FAAM). Radiological evaluation was performed using anterior drawer and varus stress radiographs with standard Telos device in 150 N. Talar tilt angles and anterior talar translation were measured both preoperatively, 1 year postoperatively and at the final follow-up.
RESULTS


Preoperative total FAOS scores for ABR and AST groups were 66.2 ± 12 and 67.1 ± 11, respectively. Postoperative Total FAOS scores for ABR and AST groups were 90.6 ± 5.2 and 91.5 ± 7.7, respectively. There was no statistical difference in between 2 groups both pre- and postoperatively (n.s). According to FAAM, sports activity scores of ABR and AST groups were 84.9 ± 14 and 90.4 ± 12 at the final follow-up, which showed that AST group was significantly superior (p = 0.02). There were no significant differences in preoperative and postoperative stress radiographs between the two groups. Mean operation time for AST and ABR groups were 35.2 min and 48.6 min, respectively, which shows statistically significantly difference (p < 0.05). There was no significant difference in recurrence rate of instability between to operation techniques (n.s).
CONCLUSIONS


Arthroscopic lateral ligament augmentation using suture tape shows comparable clinical outcomes to arthroscopic Broström repair in the treatment of chronic ankle instability at intermediate-term follow-up time. Arthroscopic lateral ligament augmentation using suture tape has a significant superiority in the terms of less operation time and no need for cast or brace immediate after surgery which allows early rehabilitation. It also has a significant superiority in the terms of FAAM scores at sports activity. However, there was no difference during daily life.
LEVEL OF EVIDENCE


II.",2020,Arthroscopic lateral ligament augmentation using suture tape has a significant superiority in the terms of less operation time and no need for cast or brace immediate after surgery which allows early rehabilitation.,"['selected cohort of patients', '31 patients whom were operated using an', 'Sixty-one consecutive patients with chronic ankle instability were operated between 2012 and 2016 randomized to 2 groups']","['Arthroscopic suture-tape internal bracing', 'suture-tape augmentation technique', 'arthroscopic Broström repair', 'lateral ligaments augmentation using suture-tape and modified Broström repair', 'arthroscopic Broström repair technique (ABR', 'Arthroscopic lateral ligament augmentation using suture tape', 'arthroscopic lateral ligaments augmentation using suture-tape internal bracing (AST']","['Preoperative total FAOS scores', 'Mean operation time', 'Foot and Ankle Outcome Score (FAOS) and Foot and Ankle Ability Measure (FAAM', 'recurrence rate of instability', 'Postoperative Total FAOS scores', 'preoperative and postoperative stress radiographs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0242592', 'cui_str': 'Lateral Ligament'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}]",61.0,0.0163386,Arthroscopic lateral ligament augmentation using suture tape has a significant superiority in the terms of less operation time and no need for cast or brace immediate after surgery which allows early rehabilitation.,"[{'ForeName': 'Tekin Kerem', 'Initials': 'TK', 'LastName': 'Ulku', 'Affiliation': 'Department of Orthopedic Surgery, Acibadem Altunizade Hospital, Acibadem University Faculty of Medicine, Tophanelioglu Cad. No: 1, Altunizade, Uskudar, Istanbul, Turkey.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Kocaoglu', 'Affiliation': 'Department of Orthopedic Surgery, Acibadem Altunizade Hospital, Acibadem University Faculty of Medicine, Tophanelioglu Cad. No: 1, Altunizade, Uskudar, Istanbul, Turkey. bariskocaoglu@gmail.com.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Tok', 'Affiliation': 'Department of Orthopedic Surgery, Acibadem Altunizade Hospital, Acibadem University Faculty of Medicine, Tophanelioglu Cad. No: 1, Altunizade, Uskudar, Istanbul, Turkey.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Irgit', 'Affiliation': 'Department of Orthopedic Surgery, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Nalbantoglu', 'Affiliation': 'Department of Orthopedic Surgery, Acibadem Altunizade Hospital, Acibadem University Faculty of Medicine, Tophanelioglu Cad. No: 1, Altunizade, Uskudar, Istanbul, Turkey.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05552-w']
838,31967678,Hyperthermic intraperitoneal chemotherapy for ovarian cancer: The heat is on.,"Patients with advanced epithelial ovarian cancer have a high incidence of peritoneal disease recurrence despite maximal efforts to surgically remove all visible tumor plus intravenous chemotherapy. The administration of intraperitoneal chemotherapy that specifically targets the peritoneal surface has been investigated in previous trials, but questions about the design of these studies has prevented this treatment from being widely adopted in clinical practice. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a single intraoperative approach that also targets the peritoneal surface. A randomized phase 3 trial showed significant benefit in recurrence-free and overall survival when HIPEC was added to interval cytoreductive surgery (CRS) in patients who were not eligible for primary surgery because of the extent of their disease (OVHIPEC trial; NCT00426257). The trial showed no important differences in toxicity or patient-reported outcomes between the study groups. The extent of surgery and the number of bowel resections were also similar between the 2 study groups, and the effect of HIPEC was homogeneous across the levels of predefined and post hoc subgroups. Nevertheless, the design and the results of the OVHIPEC trial were critically assessed, and this resembles the reluctance to adopt the positive results of the earlier intraperitoneal chemotherapy studies. This overview discusses the design and results of the OVHIPEC trial. The evidence that is currently available points to a clinically relevant and cost-effective benefit of HIPEC added to interval CRS for patients with stage III ovarian cancer who are not eligible for primary surgery. Ongoing collaborative research will provide further evidence regarding the role of HIPEC in ovarian cancer.",2019,The trial showed no important differences in toxicity or patient-reported outcomes between the study groups.,"['patients with stage III ovarian cancer who are not eligible for primary surgery', 'Patients with advanced epithelial ovarian cancer', 'ovarian cancer']","['intraperitoneal chemotherapy', 'Hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC', 'interval cytoreductive surgery (CRS', 'Hyperthermic intraperitoneal chemotherapy']","['number of bowel resections', 'recurrence-free and overall survival', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.245509,The trial showed no important differences in toxicity or patient-reported outcomes between the study groups.,"[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynecology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Cancer,['10.1002/cncr.32505']
839,31967685,Hyperthermic intraperitoneal chemotherapy does not improve survival in advanced ovarian cancer.,"Despite its widespread use, until recently, there was no randomized evidence for hyperthermic intraperitoneal chemotherapy (HIPEC) versus surgery without HIPEC for ovarian cancer. Recently, a Dutch study (OVHIPEC) reported benefits in both progression-free survival (PFS) and overall survival (OS) gained from the use of HIPEC at the time of interval debulking surgery (IDS) for stage III ovarian carcinoma, whereas a Korean randomized trial failed to show a benefit of HIPEC for patients with ovarian cancer undergoing primary debulking surgery or IDS. In colorectal cancer, 2 randomized trials failed to show an improvement in survival with HIPEC. In addition to these contradictory results, there are a number of aspects of the Dutch OVHIPEC trial in ovarian cancer that can be criticized. Some criticisms include a reduction of the number of patients needed to be randomized because of too slow accrual; much lower PFS and OS in both arms than expected according to the statistical plan; the small size of the study, with imbalances between the 2 arms (eg, more low-grade tumors in the HIPEC arm); the timing of randomization before the start of IDS; the lack of clear inclusion criteria for neoadjuvant chemotherapy; and the heterogeneity of the results, with the largest effect shown at the smaller centers. Furthermore, it is questionable whether the adverse events were reported completely. In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.",2019,"In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.","['patients with ovarian cancer undergoing primary debulking surgery or IDS', 'advanced ovarian cancer']","['Hyperthermic intraperitoneal chemotherapy', 'HIPEC', 'hyperthermic intraperitoneal chemotherapy (HIPEC) versus surgery without HIPEC']","['survival with HIPEC', 'survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.328531,"In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.","[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Chiva', 'Affiliation': 'Department of Gynecologic Oncology, MD Anderson Cancer Center, Madrid, Spain.'}]",Cancer,['10.1002/cncr.32496']
840,30894299,"The effects of 7-week cognitive training in patients with vascular cognitive impairment, no dementia (the Cog-VACCINE study): A randomized controlled trial.","INTRODUCTION


Evidence for the efficacy of cognitive training in patients with subcortical vascular cognitive impairment no dementia is still lacking.
METHODS


A randomized, active controlled design using multidomain, adaptive, computerized cognitive training for 30 minutes, 5 days/week for 7 weeks. Assessments included global cognitive function and executive function (primary outcomes) and brain functional connectivity and structural changes (secondary outcomes).
RESULTS


Sixty patients were randomized across three medical centers in Beijing. At the end of the intervention, the cognitive training group showed significant improvement in Montreal Cognitive Assessment relative to the active control group (P = .013) and significantly increased functional connectivity between the left dorsolateral prefrontal cortex and medial prefrontal cortex, which was significantly correlated with Montreal Cognitive Assessment change (P = .017).
DISCUSSION


Computerized cognitive training significantly improved global cognitive function, which was supported by the improved brain plasticity. Incorporation of biomarkers should be implemented in cognitive training trials.",2019,"At the end of the intervention, the cognitive training group showed significant improvement in Montreal Cognitive Assessment relative to the active control group (P = .013) and significantly increased functional connectivity between the left dorsolateral prefrontal cortex and medial prefrontal cortex, which was significantly correlated with Montreal Cognitive Assessment change (P = .017).
","['patients with vascular cognitive impairment, no dementia (the Cog-VACCINE study', 'patients with subcortical vascular cognitive impairment no dementia', 'Sixty patients were randomized across three medical centers in Beijing']","['multidomain, adaptive, computerized cognitive training', 'cognitive training', '7-week cognitive training', 'Computerized cognitive training']","['functional connectivity', 'brain plasticity', 'global cognitive function', 'Montreal Cognitive Assessment relative', 'global cognitive function and executive function (primary outcomes) and brain functional connectivity and structural changes (secondary outcomes', 'Montreal Cognitive Assessment change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3496286'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",60.0,0.0478476,"At the end of the intervention, the cognitive training group showed significant improvement in Montreal Cognitive Assessment relative to the active control group (P = .013) and significantly increased functional connectivity between the left dorsolateral prefrontal cortex and medial prefrontal cortex, which was significantly correlated with Montreal Cognitive Assessment change (P = .017).
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China; Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People's Republic of China, Beijing, China. Electronic address: tangyi@xwhosp.org.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China; Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People's Republic of China, Beijing, China.""}, {'ForeName': 'Zude', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Collaborative Innovation Center for Language Ability, Jiangsu Normal University, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, Beijing, China; Beijing Key Laboratory of Brain Imaging and Connectomics, Beijing, China; IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric, Fu Xing Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China; Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People's Republic of China, Beijing, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fangyu', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China; Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People's Republic of China, Beijing, China.""}, {'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Teipel', 'Affiliation': 'Department of Psychosomatic Medicine, University Medicine Rostock, Rostock, Germany; DZNE, German Center for Neurodegenerative Diseases, Rostock, Germany.'}, {'ForeName': 'Guoguang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China. Electronic address: ggzhao@vip.sina.com.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China; Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People's Republic of China, Beijing, China; Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China; Beijing Key Laboratory of Geriatric Cognitive Disorders, Beijing, China; National Clinical Research Center for Geriatric Disorders, Beijing, China; Department of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Electronic address: jiajp@vip.126.com.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.01.009']
841,31955921,A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial.,"RATIONALE & OBJECTIVE


Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD.
STUDY DESIGN


Randomized controlled trial.
SETTING & PARTICIPANTS


Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol/d.
INTERVENTION


Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period.
OUTCOMES


Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation.
RESULTS


Baseline estimated glomerular filtration rate was 55.0±22.0mL/min/1.73m 2 . During the intervention period, sodium excretion decreased in the intervention group from 188±8 (SE) to 148±8mmol/d (P<0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140±3 to 132±3mm Hg (P<0.001), but was unchanged in the control group. Mean difference in SBP across groups was-4.7 (95% CI, -10.7 to 1.3) mm Hg (P=0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160±8mmol/d (P=0.01), while it decreased in the control group from 174±9 at the end of the intervention period to 154±9mmol/d (P=0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase.
LIMITATIONS


Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up.
CONCLUSIONS


A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group.
FUNDING


Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT02132013.",2020,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","['Nephrology outpatient clinics in 4 Dutch hospitals', 'patients with CKD', '99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol', 'Patients With CKD', 'Patients with chronic kidney disease (CKD']","['Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching']","['blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation', 'sodium intake', 'systolic blood pressure (SBP', 'glomerular filtration rate', 'mean sodium excretion', 'SBP', 'sodium excretion', 'Efficacy', 'Mean difference in SBP']","[{'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2316401', 'cui_str': 'CKD stage 1'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",99.0,0.0474961,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Klaassen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: g.klaassen@umcg.nl.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Meuleman', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Verschuur', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Elisabeth J M', 'Initials': 'EJM', 'LastName': 'Straathof', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Willem Jan W', 'Initials': 'WJW', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paul J M', 'Initials': 'PJM', 'LastName': 'van der Boog', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Olivier A', 'Initials': 'OA', 'LastName': 'Blanson Henkemans', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Otten', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dijk', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Gerjan J', 'Initials': 'GJ', 'LastName': 'Navis', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.10.012']
842,31883426,Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation.,"Letermovir, a cytomegalovirus (CMV) terminase-complex inhibitor, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT). In a phase III, double-blind, randomized trial, letermovir significantly reduced the risk of clinically significant CMV infection (CS-CMVi) vs placebo through Week 24 post-HCT. This analysis investigated outcomes in participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis. In total, 70 of 565 randomized participants had detectable CMV DNA at randomization (letermovir 48; placebo 22). Study treatment completion rates were greater in letermovir-treated participants compared with placebo (52.1% vs 9.1%). The incidence of CS-CMVi or imputed primary endpoint events through Week 24 were 64.6% and 90.9% in the letermovir and placebo groups, respectively (treatment difference -26.1%; P = .010). Kaplan-Meier event rates for CS-CMVi onset through Week 14 (end-of-treatment period) were 33.1% for letermovir and 86.6% for placebo (P < .001). Median viral loads at the CS-CMVi events was similar in both treatment arms. All-cause mortality through Week 24 posttransplant was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (P = .268). Overall, clinical outcomes were similar to those reported for participants with undetectable CMV DNA at randomization.",2020,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","['participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis', 'adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT', 'patients with detectable CMV DNA at randomization in the phase III trial of', 'allogeneic hematopoietic cell transplantation']","['placebo', 'letermovir']","['risk of clinically-significant CMV infection', 'incidence of CS-CMVi', 'Median viral loads', 'mortality rates']","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852938', 'cui_str': 'letermovir'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",565.0,0.611867,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per T', 'Initials': 'PT', 'LastName': 'Ljungman', 'Affiliation': 'Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Chemaly', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Teal', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Yeh', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Randi Y', 'Initials': 'RY', 'LastName': 'Leavitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Cyrus S', 'Initials': 'CS', 'LastName': 'Badshah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15764']
843,31959014,Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study.,"BACKGROUND


We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.
METHODS


Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals.
RESULTS


On-study retention at 12 weeks was 77% (82% versus 73%;  P =0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%;  P =0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both  P <0.001; between-arms difference was 55 mmol (95% CI, 3-107;  P =0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28];  P =0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm.
CONCLUSIONS


Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.",2020,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"['Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate', 'Patients', '27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15', 'high-risk patients with heart failure']","['Low', '1500- versus 3000-mg daily sodium meals', 'sodium meals', 'NT-proBNP', 'Moderate-Sodium Diet']","['Average compliance with meals', 'Serum creatinine', 'natriuretic peptide levels, quality of life, and safety', 'Creatinine', 'tolerated', 'Quality of life', '24-hour urinary sodium', 'Food satisfaction questionnaires', 'Hospitalizations and low blood pressure events']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0301592', 'cui_str': 'Sodium diet (finding)'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",196.0,0.0541266,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Papadimitriou', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Vasiliki V', 'Initials': 'VV', 'LastName': 'Georgiopoulou', 'Affiliation': 'Department of Medicine (V.V.G.), Emory University, Atlanta, GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'School of Nursing (S.B.D.), Emory University, Atlanta, GA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Skopicki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (L.P., J.B.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006389']
844,31276981,Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor-positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.,"BACKGROUND


Randomised trials comparing the efficacy of standard endocrine therapy (ET) versus experimental ET + bevacizumab (Bev) in 1st line hormone receptor-positive patients with metastatic breast cancer have thus far shown conflicting results.
PATIENTS AND METHODS


We pooled data from two similar phase III randomised trials of ET ± Bev (LEA and Cancer and Leukemia Group B 40503) to increase precision in estimating treatment effect. Primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety. Exploratory analyses were performed within subgroups defined by patients with recurrent disease, de novo disease, prior endocrine sensitivity or resistance and reported grades III-IV hypertension and proteinuria.
RESULTS


The pooled sample consisted of 749 patients randomised to ET or ET + Bev. Median PFS was 14.3 months for ET versus 19 months for ET + Bev (unadjusted hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.66-0.91; p < 0.01). ORR and CBR with ET and ET + Bev were 40 versus 61% (p < 0.01) and 64 versus 77% (p < 0.01), respectively. There was no difference in OS (HR 0.96; 95% CI 0.77-1.18; p = 0.68). PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004). Grade III-IV hypertension (2.2 versus 20.1%), proteinuria (0 versus 9.3%), cardiovascular (0.5 versus 4.2%) and liver events (0 versus 2.9%) were significantly higher for ET + Bev (all p < 0.01). Hypertension and proteinuria were not predictors of efficacy (interaction test p = 0.33).
CONCLUSION


The addition of Bev to ET increased PFS overall and in endocrine-sensitive patients but not OS at the expense of significant additional toxicity.
TRIALS REGISTRATION


ClinicalTrial.Gov NCT00545077 and NCT00601900.",2019,PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004).,"['We pooled data from two similar phase III randomised trials of ET\xa0±', '1st line hormone receptor-positive\xa0patients with metastatic breast cancer', '749 patients randomised to ET or ET\xa0+\xa0Bev', 'patients with recurrent disease, de novo disease, prior endocrine sensitivity or resistance\xa0and reported grades III-IV hypertension and proteinuria', 'hormone receptor-positive metastatic breast cancer']","['standard endocrine therapy (ET) versus experimental ET\xa0+\xa0bevacizumab (Bev', 'bevacizumab']","['Grade III-IV hypertension', 'progression-free survival (PFS', 'Hypertension and proteinuria', 'OS', 'proteinuria', 'Bev ', 'ORR and CBR with ET and ET', 'overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety', 'cardiovascular', 'liver events', 'Median PFS']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.14133,PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense Madrid, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain. Electronic address: mmartín@geicam.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hyslop', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De la Haba-Rodríguez', 'Affiliation': 'Oncology Department and Research Unit, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Reina Sofía, Universidad de Córdoba Spain. Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': ""University Women's Hospital Leipzig, Leipzig, Germany.""}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Cirrincione', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Alliance Statistics and Data Center, Dana-Farber/Partners Cancer Care, Boston, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Medical Oncology, Hospital Arnau de Vilanova de Lérida, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Garcia-Saenz', 'Affiliation': 'Medical Oncology, Instituto de Investigación Sanitaria del Hospital Clinico San Carlos (IdISSC) Madrid, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martinez-Jañez', 'Affiliation': 'Medical Oncology. Universitary Hospital Ramon y Cajal. GEICAM, Spanish Breast Cancer Group; Madrid, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerrero-Zotano', 'Affiliation': 'Medical Oncology. Valencian Institute of Oncology. GEICAM Spanish Breast Cancer Group, Valencia, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hudis', 'Affiliation': 'American Society of Clinical Oncology (ASCO), Alexandria, VA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Casas', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rodriguez-Martin', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dickler', 'Affiliation': 'Eli Lilly and Co. Indianapolis, IN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.002']
845,31944878,"A Comparative Assessment of the Efficiency of Orthodontic Treatment With and Without Photobiomodulation During Mandibular Decrowding in Young Subjects: A Single-Center, Single-Blind Randomized Controlled Trial.","Objective:  To assess if photobiomodulation (PBM) improves the efficiency of orthodontic treatment with fixed appliance during the alignment stage.  Methods:  Eighty-nine subjects were included in this trial and randomly assigned for treatment with fixed appliance and PBM group or with fixed appliance only (control group). Inclusion criteria were as follows: (1) age between 13 and 30 years, (2) permanent dentition, (3) class I malocclusion, (4) lower 6-6 mild crowding measured on dental cast, (5) no spaces or diastema in the lower arch, (6) no ectopic teeth, (7) nonextractive treatment plan, and (8) no previous orthodontic treatment. PBM was administered in the PBM group every 14 days using the ATP38 ®  (Biotech Dental, Allée de Craponne, Salon de Provence, France) (72 J/cm 2  of fluency for each session). Dental alignment was assessed by visual inspection, and treatment time was defined in days as T2 (date of assessment of complete dental alignment)-T1 (date of brackets bonding). The number of monthly scheduled appointments was also recorded. All the data underwent statistical analysis for comparison between groups.  Results:  Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days). Consequently, control visits ( p  < 0.001) were lower in the PBM group (7) compared with the control group (9).  Conclusions:  The present findings would confirm that PBM can be used to enhance the efficiency of orthodontic treatment during dental decrowding.",2020,Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days).,"['1) age between 13 and 30 years, (2) permanent dentition, (3) class', 'Methods:  Eighty-nine subjects', 'Young Subjects']","['fixed appliance and PBM group or with fixed appliance only (control group', 'PBM', 'photobiomodulation (PBM', 'Orthodontic Treatment With and Without Photobiomodulation']","['number of monthly scheduled appointments', 'Treatment time']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",89.0,0.0846448,Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Lo Giudice', 'Affiliation': 'Section of Orthodontics, Department of Medical-Surgical Specialties, School of Dentistry, University of Catania, Policlinico Universitario ""V. Emanuele,"" Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Nucera', 'Affiliation': 'Section of Orthodontics, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, School of Dentistry, University of Messina, Policlinico Universitario ""G. Martino,"" Messina, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Leonardi', 'Affiliation': 'Section of Orthodontics, Department of Medical-Surgical Specialties, School of Dentistry, University of Catania, Policlinico Universitario ""V. Emanuele,"" Catania, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Paiusco', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Baldoni', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Caccianiga', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4747']
846,31633254,Effects of ketamine and midazolam on resting state connectivity and comparison with ENIGMA connectivity deficit patterns in schizophrenia.,"Subanesthetic administration of ketamine is a pharmacological model to elicit positive and negative symptoms of psychosis in healthy volunteers. We used resting-state pharmacological functional MRI (rsPhfMRI) to identify cerebral networks affected by ketamine and compared them to the functional connectivity (FC) in schizophrenia. Ketamine can produce sedation and we contrasted its effects with the effects of the anxiolytic drug midazolam. Thirty healthy male volunteers (age = 19-37 years) underwent a randomized, three-way, cross-over study consisting of three imaging sessions, with 48 hr between sessions. A session consisted of a control period followed by infusion of placebo or ketamine or midazolam. The ENIGMA rsfMRI pipeline was used to derive two long-distance (seed-based and dual-regression) and one local (regional homogeneity, ReHo) FC measures. Ketamine induced significant reductions in the connectivity of the salience network (Cohen's d: 1.13 ± 0.28, p = 4.0 × 10 -3  ), auditory network (d: 0.67 ± 0.26, p = .04) and default mode network (DMN, d: 0.63 ± 0.26, p = .05). Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03). The effect sizes for ketamine for resting networks showed a positive correlation (r = .59, p = .07) with the effect sizes for schizophrenia-related deficits derived from ENIGMA's study of 261 patients and 327 controls. Effect sizes for midazolam were not correlated with the schizophrenia pattern (r = -.17, p = .65). The subtraction of ketamine and midazolam patterns showed a significant positive correlation with the pattern of schizophrenia deficits (r = .68, p = .03). RsPhfMRI reliably detected the shared and divergent pharmacological actions of ketamine and midazolam on cerebral networks. The pattern of disconnectivity produced by ketamine was positively correlated with the pattern of connectivity deficits observed in schizophrenia, suggesting a brain functional basis for previously poorly understood effects of the drug.",2020,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","['261 patients and 327 controls', 'Thirty healthy male volunteers (age = 19-37\u2009years', 'schizophrenia', 'healthy volunteers']","['midazolam', 'Midazolam', 'Ketamine', 'ketamine', 'placebo or ketamine or midazolam', 'ketamine and midazolam', 'resting-state pharmacological functional MRI (rsPhfMRI']","['schizophrenia pattern', 'auditory network', 'schizophrenia deficits', 'connectivity of the salience network', 'cerebral networks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.077698,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","[{'ForeName': 'Bhim M', 'Initials': 'BM', 'LastName': 'Adhikari', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Joerg F', 'Initials': 'JF', 'LastName': 'Hipp', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Meghann C', 'Initials': 'MC', 'LastName': 'Ryan', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'L Elliot', 'Initials': 'LE', 'LastName': 'Hong', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Eickhoff', 'Affiliation': 'Institute of Neuroscience and Medicine, Brain & Behaviour (INM-7), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jahandshad', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Thompson', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Rowland', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kochunov', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Human brain mapping,['10.1002/hbm.24838']
847,31926951,Early gestational diabetes screening in obese women: a randomized controlled trial.,"BACKGROUND


Although in 2013 the American College of Obstetricians and Gynecologists recommended early screening for gestational diabetes in obese women, no studies demonstrate an improvement in perinatal outcomes with this strategy.
OBJECTIVE


We sought to determine whether early screening for gestational diabetes improves perinatal outcomes in obese women.
MATERIALS AND METHODS


Randomized controlled trial comparing early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (body mass index ≥30 kg/m 2 ) at 2 tertiary care centers in the United States. Screening was performed using a 50-g, 1-hour glucose challenge test followed by a 100-g, 3-hour glucose tolerance test if the initial screen was ≥135 mg/dL. Gestational diabetes was diagnosed using Carpenter-Coustan criteria. Women not diagnosed at 14 to 20 weeks were rescreened at 24 to 28 weeks. Exclusion criteria were pre-existing diabetes, major medical illness, bariatric surgery, and prior cesarean delivery. The primary outcome was a composite of macrosomia (>4000 g), primary cesarean delivery, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth).
RESULTS


A total of 962 women were randomized, and outcomes were available for 922. Of these 922 women, 459 (49.8%) were assigned to early screen and 463 (50.2%) to routine screen. Baseline characteristics were balanced between groups. In the early screening group, 69 (15.0%; 95% confidence interval, 11.9-18.6%) were diagnosed with gestational diabetes: 29 (6.3%; 95% confidence interval, 4.3-8.9%) at <20 weeks and 40 (8.7%; 95% confidence interval, 6.3-11.7%) at >24 weeks. Of those randomized to routine screening, 56 (12.1%; 95% confidence interval, 9.3-15.4%) had gestational diabetes. Early screening did not reduce the incidence of the primary outcome (56.9% in the early screen versus 50.8% in the routine screen, P = .07; relative risk, 1.12; 95% confidence interval, 0.99-1.26).
CONCLUSION


Early screening for gestational diabetes in obese women did not reduce the composite perinatal outcome.",2020,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26).
","['early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (BMI≥30 kg/m 2 ) at two tertiary care centers in the US', 'A total of 962 women', 'Early Gestational Diabetes Screening in Obese Women', 'obese women', 'gestational diabetes in obese women']",[],"['diagnosed with gestational diabetes', 'composite of macrosomia (>4000g), primary cesarean, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth', 'gestational diabetes']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",[],"[{'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia (disorder)'}, {'cui': 'C0857007', 'cui_str': 'Hyperbilirubinemia, Neonatal'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",962.0,0.519412,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26).
","[{'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL. Electronic address: lmharper@uabmc.edu.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jauk', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ""Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL; Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.021']
848,31181221,Home visits for uncontrolled asthma among low-income adults with patient portal access.,"BACKGROUND


Asthma disproportionately affects low-income and minority adults. In an era of electronic records and Internet-based digital devices, it is unknown whether portals for patient-provider communication can improve asthma outcomes.
OBJECTIVE


We sought to estimate the effect on asthma outcomes of an intervention using home visits (HVs) by community health workers (CHWs) plus training in patient portals compared with usual care and portal training only.
METHODS


Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training. Half were randomized to HVs over 6 months by CHWs to facilitate competency in portal use and promote care coordination.
RESULTS


One hundred seventy (56%) patients used the portal independently. Rates of portal activity did not differ between randomized groups. Asthma control and asthma-related quality of life improved in both groups over 1 year. Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024). Poor neighborhoods and living conditions plus limited Internet access were barriers for patients to complete the protocol and for CHWs to make HVs.
CONCLUSION


For low-income adults with uncontrolled asthma, portal access and CHWs produced small incremental benefits. HVs with emphasis on self-management education might be necessary to facilitate patient-clinician communication and to improve asthma outcomes.",2019,"Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024).","['uncontrolled asthma among low-income adults with patient portal access', 'Asthma disproportionately affects low-income and minority adults', 'Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training', 'One hundred seventy (56%) patients used the portal independently']","['intervention using home visits (HVs) by community health workers (CHWs) plus training', 'usual care and portal training only']","['yearly hospitalization rate', 'Rates of portal activity', 'Asthma control and asthma-related quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",301.0,0.0640998,"Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024).","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; University of Pennsylvania Health System, Philadelphia, Pa. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple Physicians, Temple University Health System, Philadelphia, Pa.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; University of Pennsylvania Health System, Philadelphia, Pa.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pa; Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Howell', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pa.'}, {'ForeName': 'Maryori N', 'Initials': 'MN', 'LastName': 'Canales', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.05.030']
849,31184922,Engagement and Weight Loss: Results from the Mobile Health and Diabetes Trial.,"Background:  Prevalence of type 2 diabetes (T2D) is increasing worldwide. Identifying and targeting individuals at high risk, is essential for preventing T2D. Several studies point to mobile health initiatives delivered through personal smart devices being a promising approach to diabetes prevention, through weight loss. The aim of the mobile health and diabetes (mDiab) trial was twofold: to achieve 5% weight loss and to look at the association of weight loss with degree of engagement with the mDiab app.  Methods:  The mDiab randomized control trial was carried out among smartphone users who are at high risk for T2D mellitus in three cities-Chennai, Bengaluru, and New Delhi in India. The intervention was delivered through a mobile phone application along with weekly coach calls for 12 weeks. While individuals in the intervention group individuals received the app, which enabled tracking their weight, physical activity, and diet along with 12 weekly video lessons on T2D prevention and coach calls, the control group received usual care.  Results:  The intervention group experienced a significant 1 kg weight loss while the control group lost 0.3 kg ( P  < 0.05). More individuals in the intervention group ( n  = 139, 15%) met the 5% weight loss target than in the control group ( n  = 131, 9%). In the intervention group those who viewed the videos experienced greater weight loss (2.4 kg) than those who only attended coach calls (0.9 kg) ( P  < 0.01).  Conclusions:  An mHealth intervention helped to achieve moderate weight loss. Future studies should explore the sustainability of this weight loss.",2019,In the intervention group those who viewed the videos experienced greater weight loss (2.4 kg) than those who only attended coach calls (0.9 kg),"['smartphone users who are at high risk for T2D mellitus in three cities-Chennai, Bengaluru, and New Delhi in India']","['T2D prevention and coach calls, the control group received usual care']","['weight loss', 'kg weight loss', 'moderate weight loss', 'weight loss target', 'Engagement and Weight Loss']","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.0464367,In the intervention group those who viewed the videos experienced greater weight loss (2.4 kg) than those who only attended coach calls (0.9 kg),"[{'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Muralidharan', 'Affiliation': 'Global Obesity Center (GLOBE), Center for Population Health Research & WHO Collaborating Center for Obesity Prevention, Deakin University, Geelong, Australia.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ranjani', 'Affiliation': ""Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Center, WHO Collaborating Center for Prevention and Control of Noncommunicable Diseases & IDF Centre of Excellence in Diabetes Care, Chennai, India.""}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Mohan Anjana', 'Affiliation': ""Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Center, WHO Collaborating Center for Prevention and Control of Noncommunicable Diseases & IDF Centre of Excellence in Diabetes Care, Chennai, India.""}, {'ForeName': 'Sidhant', 'Initials': 'S', 'LastName': 'Jena', 'Affiliation': 'Janacare Solutions Private Limited, Bengaluru, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Yashdeep', 'Initials': 'Y', 'LastName': 'Gupta', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Samita', 'Initials': 'S', 'LastName': 'Ambekar', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Koppikar', 'Affiliation': 'Janacare Solutions Private Limited, Bengaluru, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jagannathan', 'Affiliation': ""Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Center, WHO Collaborating Center for Prevention and Control of Noncommunicable Diseases & IDF Centre of Excellence in Diabetes Care, Chennai, India.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Allender', 'Affiliation': 'Global Obesity Center (GLOBE), Center for Population Health Research & WHO Collaborating Center for Obesity Prevention, Deakin University, Geelong, Australia.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Center, WHO Collaborating Center for Prevention and Control of Noncommunicable Diseases & IDF Centre of Excellence in Diabetes Care, Chennai, India.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0134']
850,31899198,Relationships of self-perceived age with geriatric assessment domains in older adults with cancer.,"OBJECTIVES


Older self-perceived age is associated with poor health and higher healthcare utilization in the geriatric population. We evaluated the associations of self-perceived age with geriatric assessment (GA) domain impairments in older adults with cancer.
METHODS


This was a secondary analysis of baseline data from a GA cluster-randomized trial (URCC 13070; PI: Mohile). We included patients aged ≥70 with incurable stage III/IV solid tumor or lymphoma considering or receiving treatment and had ≥1 GA domain impairment other than polypharmacy. Multivariate analyses were used to evaluate the associations of age difference between chronological and self-perceived age (categorized into ""feeling younger than chronological age"" vs. ""feeling the same or older than their chronological age"") with GA domain impairments.
RESULTS


We included 533 patients; mean age was 76.6 (SD 5.2). On multivariate analyses, compared to those who felt younger than their chronological age, those who felt the same or older were more likely to have impairments in physical performance [Adjusted Odds Ratio (AOR) 5.42, 95% Confidence Interval (CI) 1.69-17.40)], functional status (AOR 2.31, 95% CI 1.73-3.07), comorbidity (AOR 1.62, 95% CI 1.20-2.19), psychological health (AOR 2.62, 95% CI 1.85-3.73), and nutrition (AOR 1.65, 95% CI 1.20-2.28). They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65).
CONCLUSIONS


Older adults with cancer who felt the same or older than their chronological age were more likely to have GA domain impairments. Further studies are needed to better understand the relationships between self-perceived age, aging-related conditions, and outcomes in this population.",2019,"They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65).
","['533 patients; mean age was 76.6 (SD 5.2', 'patients aged ≥70 with incurable stage III/IV solid tumor or lymphoma considering or receiving treatment and had ≥1 GA domain impairment other than polypharmacy', 'Older adults with cancer who felt the same or older than their chronological age', 'older adults with cancer']",[],"['physical performance [Adjusted Odds Ratio (AOR', 'comorbidity', 'psychological health', 'functional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",[],"[{'cui': 'C2607857'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",533.0,0.0707127,"They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65).
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: kahpoh_loh@urmc.rochester.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, New Brunswick, NJ, USA. Electronic address: paul_duberstein@rutgers.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Zittel', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: jason_zittel@urmc.rochester.edu.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: lianlian_lei@urmc.rochester.edu.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: eva_culakova@urmc.rochester.edu.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: huiwen_xu@urmc.rochester.edu.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: sandy_plumb@urmc.rochester.edu.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: marie_flannery@urmc.rochester.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: allison_magnuson@urmc.rochester.edu.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: javier_bautista@urmc.rochester.edu.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: marsha_wittink@urmc.rochester.edu.'}, {'ForeName': 'Nikesha', 'Initials': 'N', 'LastName': 'Gilmore', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: nikesha_gilmore@urmc.rochester.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Targia', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium National Cancer Institute Community Oncology Research Program (NCORP), Seattle, WA, USA. Electronic address: alison.conlin@providence.org.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Berenberg', 'Affiliation': 'Hawaii National Cancer Institute Community Oncology Research Program (MU-NCORP), Honolulu, HI, USA. Electronic address: berenber@hawaii.edu.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Vogel', 'Affiliation': 'Geisinger Cancer Institute NCORP, Danville, PA, USA. Electronic address: vgvogel@geisinger.edu.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: supriya_mohile@urmc.rochester.edu.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.12.011']
851,31006118,Differential vascular effects of aspirin in people with Type 2 diabetes without cardiovascular disease and matched controls without diabetes.,"AIM


We investigated whether the effect of low-dose aspirin on endothelium-dependent vasodilation and arterial stiffness in people with Type 2 diabetes is different from a matched control group. We examined acute and chronic effects, and effects over the 24h dosing interval.
METHODS


In an open-label parallel group intervention study, we included 21 participants with Type 2 diabetes and 21 age- and sex-matched controls. Endothelium-dependent vasodilation was assessed as the reactive hyperaemia index (lnRHI) measured by peripheral arterial tonometry (EndoPAT ®  ). Arterial stiffness was assessed as pulse wave velocity (PWV) measured by applanation tonometry (SphygmoCor ®  ). Measurements were performed prior to aspirin intake and 1h after aspirin administration (75 mg). Participants were then treated for 6 days, and measurements were repeated at 24 h and 1 h after aspirin intake.
RESULTS


Baseline lnRHI did not differ between groups. The controls had an immediate increase in lnRHI after the first aspirin tablet. This was not observed in participants with diabetes (difference between groups; P < 0.05). After 1 week, both groups demonstrated increased lnRHI compared with baseline (P < 0.01). In participants with diabetes, lnRHI was significantly lower 24 h after aspirin administration compared with 1 h after administration (P < 0.05). This difference was not observed in controls (P = 0.84, difference between groups; P = 0.12). The effect on PWV did not differ between groups.
CONCLUSION


Aspirin had a reduced immediate effect on endothelium-dependent vasodilation in participants with diabetes. Both groups had improved endothelial function after 1 week of treatment. Further, the effect of aspirin on endothelial function may be declining during a 24 h dosing interval in people with Type 2 diabetes. (Clinical Trial Registry No: 2016-000515-32).",2019,"This difference was not observed in controls (P = 0.84, difference between groups; P = 0.12).","['people with Type 2 diabetes', '21 participants with Type 2 diabetes and 21 age- and sex-matched controls', 'people with Type 2 diabetes without cardiovascular disease and matched controls without diabetes', 'participants with diabetes']","['Aspirin', 'low-dose aspirin', 'aspirin']","['endothelium-dependent vasodilation', 'pulse wave velocity (PWV) measured by applanation tonometry (SphygmoCor ®  ', 'reactive hyperaemia index (lnRHI', 'endothelial function', 'PWV', 'endothelium-dependent vasodilation and arterial stiffness', 'lnRHI', 'Arterial stiffness', 'Endothelium-dependent vasodilation']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}]",21.0,0.143731,"This difference was not observed in controls (P = 0.84, difference between groups; P = 0.12).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vernstrøm', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Laugesen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Grove', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Baier', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gullaksen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Poulsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Funck', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13978']
852,31925809,Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia.,"AIMS


To determine the effects of statins on postprandial lipaemia (PPL) and to study if exercise could enhance statin actions.
METHODS


Ten hypercholesteraemic (blood cholesterol 204 ± 36 mg dL -1  ; low-density lipoprotein-cholesterol 129 ± 32 36 mg dL -1  ) overweight (body mass index 30 ± 4 kg m -2  ), metabolic syndrome individuals chronically medicated with statins (>6 months) underwent 5-hour PPL tests in 4 occasions in a randomized order: (i) substituting their habitual statin medication by placebo for 96 hours (PLAC trial); (ii) taking their habitual statin medicine (STA trial); (iii) placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial); and (iv) combining exercise and statin medicine (EXER+STA trial).
RESULTS


Before the fat meal, statin withdrawal (i.e. PLAC and EXER+PLAC) increased blood triglycerides (TG; 24%), low-density lipoprotein-cholesterol (31%) and total cholesterol (19%; all P < .05) evidencing treatment compliance. After the meal, statin withdrawal increased 5-hour postprandial TG (PPTG) compared to its matched trials (94% higher PLAC vs STA and 45% higher EXER+PLAC vs EXER+STA; P < .05). EXER+PLAC trial did not lower PPTG below PLAC (i.e. incremental AUC of 609 ± 152 vs 826 ± 190 mg dL -1  5 h; P = .09). Adding exercise to statin did not result in larger reductions in PPTG (i.e. EXER+STA vs STA incremental area under the curve of 421 ± 87 vs 421 ± 84 mg dL -1  5 h; P = .99).
CONCLUSION


In hypercholesteraemic metabolic syndrome individuals, chronic statin therapy blunts the elevations in TG after a fat meal (i.e. incremental area under the curve of PPTG) reducing the cardiovascular risk associated to their atherogenic dyslipidaemia. However, a single bout of intense aerobic exercise before the high fat meal, does not reduce PPTG but also does not interfere with the effects of statin treatment.",2020,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[' LDL-c 129±32 36 mg·dL -1  ) overweight (BMI 30±4 kg·m -2  ), metabolic syndrome (MetS) individuals chronically medicated with statins (> 6 months', 'overweight individuals with hypercholesterolemia', 'Ten hypercholesterolemic (blood cholesterol', '204±36']","['habitual statin medication by placebo', 'placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial) and d) combining exercise and statin medicine (EXER+STA trial', 'fat meal', 'EXER+PLAC', 'statins therapy and exercise', 'statins']","['postprandial triglycerides', 'blood triglycerides', 'total cholesterol', 'statin withdrawal increased 5-h postprandial TG (PPTG', 'LDL-c', 'mg·dL -1']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",10.0,0.111124,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14217']
853,31934925,Change in Defense Mechanisms and Depression in a Pilot Study of Antidepressive Medications Plus 20 Sessions of Psychotherapy for Recurrent Major Depression.,"Treatment studies of major depression commonly focus on symptoms, leaving aside change in putative psychological risk factors. This pilot study examines the relationship between changes in eight depressive defenses and depressive symptoms. Twelve adults with acute recurrent major depression were given antidepressive medications and randomized to 20 sessions of either cognitive behavioral therapy or dynamic psychotherapy and followed for 1 year. Defenses were assessed using the Defense Mechanism Rating Scales (DMRS) and Defense Style Questionnaire (DSQ) at intake, termination, and 1-year follow-up. Depression improved highly significantly on both the Hamilton Rating Scale for Depression and Beck Depression Inventory, respectively, eight (67%) and nine (75%) patients attained recovery by 1 year. Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year. A mean of 12.17% (SD = 10.60) depressive defenses remained; only five subjects (50%) attained normative levels. Although causal relationships were not established, depressive defenses are promising candidates for mediating treatment effects on outcome of major depression.",2020,"Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year.",['Twelve adults with acute recurrent major depression'],['cognitive behavioral therapy or dynamic psychotherapy'],"['Defense Mechanism Rating Scales (DMRS) and Defense Style Questionnaire (DSQ) at intake, termination, and 1-year follow-up', 'Hamilton Rating Scale for Depression and Beck Depression Inventory', 'Depressive defenses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0011142', 'cui_str': 'Defense Mechanisms'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",12.0,0.0395845,"Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year.","[{'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Perry', 'Affiliation': 'Institute of Community and Family Psychiatry, Jewish General Hospital; and McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Banon', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bond', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001112']
854,31926893,Laser pretreatment for the attenuation of planned surgical scars: A randomized self-controlled hemi-scar pilot study.,"BACKGROUND


Nonsurgical scar attenuation options include compression garments, silicone gel, intralesional drug therapy, radiation therapy, laser, and light therapies. Laser application preceding surgical intervention has been shown to modify the wound-healing process and affect subsequent scar formation. The objective of this study was to evaluate the safety, efficacy, and final cosmesis of a single presurgical laser treatment on surgical scar formation.
METHODS


This was a randomized, controlled, intraindividual split-scar pilot study with blinded assessments of treated versus untreated planned incision sites. One half of each planned scar was treated by means of an Erbium glass, 1540 nm laser, 24 h before surgery, and the other half was not treated and served as the control. Clinical evaluations and the measurements of patient and physician POSAS scales were done at 1 and 12 months following surgery.
RESULTS


Eleven patients completed the study and were included in the analyses. Laser pretreatment showed a significant beneficial effect compared with no treatment. Both the patient and physician mean Patient and Observer Scar Assessment Scale scores were significantly lower for the laser-treated half of the scars compared with the control side (1.55 to 3.00, p = 0.02 and 2.28 to 4.42, p = 0.03). There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
CONCLUSION


A single presurgical laser treatment of a planned incision site is a simple, safe, and painless strategy to significantly improve the final scar appearance.",2020,"There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
","['Eleven patients completed the study and were included in the analyses', 'planned surgical scars']","['Laser pretreatment', 'single presurgical laser treatment']","['Observer Scar Assessment Scale scores', 'patient and physician POSAS scales', 'safety, efficacy, and final cosmesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar (morphologic abnormality)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",,0.0309942,"There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
","[{'ForeName': 'Or', 'Initials': 'O', 'LastName': 'Friedman', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel. Electronic address: or.friedman@gmail.com.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Gofstein', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Arad', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Gur', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Division of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Artzi', 'Affiliation': 'Division of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.046']
855,31939337,A Solution-Focused Coaching Intervention with Children and Youth with Cerebral Palsy to Achieve Participation-Oriented Goals.,"Background:  The ultimate goal of therapeutic intervention is meaningful participation in one's world. For people with Cerebral Palsy (CP), limitations can often become a focus of care. Aim:  Our purpose was to investigate the impact of a Solution-Focused Coaching intervention designed for pediatric rehabilitation (SFC-peds) on the attainment of participation goals for children/youth with CP. Method:  Twelve participants participated in a repeated measures quantitative study and in qualitative interviews. Children and youth (ages 6-19) and their families participated in three to five coaching sessions, including an initial baseline goal setting session, with one additional follow-up session as well as the qualitative interviews. The Canadian Occupational Performance Measure and Goal Attainment Scaling were incorporated into initial coaching sessions and then re-administered by a blind assessor within one month post-intervention. Qualitative interviews were conducted at this time. Results:  Statistically significant improvements were found in goal performance, satisfaction, and attainment. Interview data included consideration of both the content of the intervention ( what  the practitioner is doing) and the unique SFC-peds process ( how  the client feels about the intervention). Conclusions:  SFC-peds may present an effective approach for working with children/youth with CP to achieve self-selected participation-oriented goals in a relatively short time-period.",2020,"Statistically significant improvements were found in goal performance, satisfaction, and attainment.","['Children and Youth with Cerebral Palsy', 'children/youth with CP', 'Twelve participants participated in a repeated measures quantitative study and in qualitative interviews', 'Children and youth (ages 6-19) and their families participated', 'people with Cerebral Palsy (CP']","['A Solution-Focused Coaching Intervention', 'Solution-Focused Coaching intervention designed for pediatric rehabilitation (SFC-peds']","['goal performance, satisfaction, and attainment', 'Canadian Occupational Performance Measure and Goal Attainment Scaling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}]",12.0,0.0152257,"Statistically significant improvements were found in goal performance, satisfaction, and attainment.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Schwellnus', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'King', 'Affiliation': 'Bloorview Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Baldwin', 'Affiliation': 'Private practice, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Keenan', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Hartman', 'Affiliation': 'Bloorview Research Institute, Toronto, Ontario, Canada.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1711841']
856,31921171,Increasing Time in Therapeutic Range of Tacrolimus in the First Year Predicts Better Outcomes in Living-Donor Kidney Transplantation.,"Background:  The aim of the present study was to investigate the impact of time in therapeutic range TTR on long-term outcomes of living kidney transplants.  Methods:  We included 1,241 living kidney transplants and randomized them into development and validation cohorts with a ratio of 2:1. The tacrolimus TTR percentage was calculated by linear interpolation with a target range (5-10 ng/ml months 0-3, 4-8 ng/ml months 4-12). The optimal TTR cutoff was estimated by the receiver operating characteristic curve analysis on the basis of acute rejection (AR) within 12 months in the development cohort. Outcomes were analyzed between patients with high TTR and low TTR in the development and validation cohorts, respectively. The TTR was also compared with other tacrolimus measures.  Results:  The optimal TTR cutoff value was 78%. In the development cohort, patients with TTR > 78% had significantly higher rejection- and infection-free survival. TTR < 78% was an independent risk factor for AR (OR: 2.97, 95%CI: 1.82-4.84) and infection (OR: 1.55, 95%CI: 1.08-2.22). Patient and graft survival were significantly higher in those with TTR>78%, and TTR<78% was associated with graft loss (OR: 3.2, 95%CI: 1.38-7.42) and patient death (OR: 6.54, 95%CI: 1.34-31.77). These findings were confirmed in the validation cohort. Furthermore, we divided all included patients into a high and low TTR group. TTR was more strongly associated with patient and graft survival than mean level, standard deviation, and intrapatient variability (IPV).  Conclusions:  Increasing the TTR of tacrolimus in the first year was associated with improved long-term outcomes in living kidney transplants, and TTR may be a novel valuable strategy to monitor tacrolimus exposure.",2019,"Patient and graft survival were significantly higher in those with TTR>78%, and TTR<78% was associated with graft loss (OR: 3.2, 95%CI: 1.38-7.42) and patient death (OR: 6.54, 95%CI: 1.34-31.77).","['Living-Donor Kidney Transplantation', '1,241 living kidney transplants and randomized them into development and validation cohorts with a ratio of 2:1']",['Tacrolimus'],"['tacrolimus TTR percentage', 'Patient and graft survival', 'rejection- and infection-free survival', 'risk factor for AR ', 'intrapatient variability (IPV', 'patient and graft survival', 'graft loss', 'patient death']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1241.0,0.0759871,"Patient and graft survival were significantly higher in those with TTR>78%, and TTR<78% was associated with graft loss (OR: 3.2, 95%CI: 1.38-7.42) and patient death (OR: 6.54, 95%CI: 1.34-31.77).","[{'ForeName': 'Turun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Saifu', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhongli', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhiling', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xianding', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Urology Department, Urology Research Institute, Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu, China.'}]",Frontiers in immunology,['10.3389/fimmu.2019.02912']
857,31942744,The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial.,"BACKGROUND


Hip fracture is a common clinical problem which causes severe pain in geriatric patients. However, severe pain following fracture may bring on mental disorders and delirium. A neuroinflammatory response with IL-6 and IL-8 has been shown to be associated with the pathophysiology of delirium. In this study, our primary hypothesis is that preoperative femoral nerve block (FNB) intervention in geriatric patients will more effectively attenuate pain following trochanteric femur fracture than the preoperative paracetamol application. Our secondary hypothesis is that interleukin levels (IL-6, IL-8) in cerebrospinal fluid (CSF) will be lower in the femoral nerve block group than the paracetamol group. Our tertiary hypothesis is that the incidence of postoperative delirium will be lower in the femoral nerve block group.
METHODS


The patients over 65 years of age with ASA status II-IV and admitted to the Emergency Service for femur fracture were included in this study. Recommendations of the 'delirium prevention table' were applied to all of the patients at arrival. In the first group, 15 mg/kg paracetamol was administered intravenously every eight hours. In the second group, femoral nerve blockage was performed, and a catheter was placed. Then, 0.5 mL/kg bupivacaine 0.25% was applied every eight hours. In both groups, pain scores four hours after interventions were recorded. All patients were operated within 48 hours under spinal anesthesia. During spinal anesthesia, 2 mL of CSF samples were taken from all patients for analysis of IL-6 and IL-8 cytokines, and pain scores during positioning were recorded.
RESULTS


VAS scores four hours after the first preoperative pain treatment and during the positioning for regional anesthesia were significantly lower in the femoral nerve block group. IL-8 levels are significantly lower in the femoral nerve block group but not in IL-6 levels. The incidence of delirium was less in the femoral nerve block group, but the difference was not statistically significant.
CONCLUSION


The femoral nerve block was more effective in preoperative pain management of trochanteric femur fracture and preventing pain during regional anesthesia application. The mean IL-8 level was lower in the femoral nerve block group when compared to the paracetamol group. There is no difference in the postoperative delirium incidence between groups.",2020,The mean IL-8 level was lower in the femoral nerve block group when compared to the paracetamol group.,"['geriatric patients', 'All patients were operated within 48 hours under spinal anesthesia', 'patients over 65 years of age with ASA status II-IV and admitted to the Emergency Service for femur fracture', 'postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery']","['bupivacaine', 'paracetamol', 'early femoral nerve block intervention', 'preoperative femoral nerve block (FNB) intervention']","['femoral nerve blockage', 'IL-6 and IL-8 cytokines, and pain scores', 'incidence of delirium', 'pain scores', 'mean IL-8 level', 'interleukin levels (IL-6, IL-8) in cerebrospinal fluid (CSF', 'postoperative delirium incidence', 'severe pain', 'VAS scores', 'IL-8 levels', 'postoperative delirium']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0015808', 'cui_str': 'Femoral Nerve'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1328460', 'cui_str': 'Interleukin level'}, {'cui': 'C0007807'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.111586,The mean IL-8 level was lower in the femoral nerve block group when compared to the paracetamol group.,"[{'ForeName': 'Ali İhsan', 'Initials': 'Aİ', 'LastName': 'Uysal', 'Affiliation': 'Department of Anesthesiology and Reanimation, Muğla Sıtkı Koçman University Training and Research Hospital, Muğla-Turkey.'}, {'ForeName': 'Başak', 'Initials': 'B', 'LastName': 'Altıparmak', 'Affiliation': 'Department of Anesthesiology and Reanimation, Muğla Sıtkı Koçman University Faculty of Medicine, Muğla-Turkey.'}, {'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Yaşar', 'Affiliation': 'Department of Anesthesiology and Reanimation, Muğla Sıtkı Koçman University Training and Research Hospital, Muğla-Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Muğla Sıtkı Koçman University Faculty of Medicine, Muğla-Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Canbek', 'Affiliation': 'Department of Orthopedics and Traumatology, Muğla Sıtkı Koçman University Faculty of Medicine, Muğla-Turkey.'}, {'ForeName': 'Nigar', 'Initials': 'N', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Biochemstry, Muğla Sıtkı Koçman University Faculty of Medicine, Muğla-Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Gümüş Demirbilek', 'Affiliation': 'Department of Anesthesiology and Reanimation, Muğla Sıtkı Koçman University Faculty of Medicine, Muğla-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.78002']
858,31942969,Falls Risk in Relation to Activity Exposure in High-Risk Older Adults.,"BACKGROUND


Physical activity is linked to many positive health outcomes, stimulating the development of exercise programs. However, many falls occur while walking and so promoting activity might paradoxically increase fall rates, causing injuries, and worse quality of life. The relationship between activity exposure and fall rates remains unclear. We investigated the relationship between walking activity (exposure to risk) and fall rates before and after an exercise program (V-TIME).
METHODS


One hundred and nine older fallers, 38 fallers with mild cognitive impairment (MCI), and 128 fallers with Parkinson's disease (PD) were randomly assigned to one of two active interventions: treadmill training only or treadmill training combined with a virtual reality component. Participants were tested before and after the interventions. Free-living walking activity was characterized by volume, pattern, and variability of ambulatory bouts using an accelerometer positioned on the lower back for 1 week. To evaluate that relationship between fall risk and activity, a normalized index was determined expressing fall rates relative to activity exposure (FRA index), with higher scores indicating a higher risk of falls per steps taken.
RESULTS


At baseline, the FRA index was higher for fallers with PD compared to those with MCI and older fallers. Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p ≤ .035).
CONCLUSIONS


This work showed that V-TIME interventions reduced falls risk without concurrent change in walking activity. We recommend using the FRA index in future fall prevention studies to better understand the nature of intervention programs.",2020,"Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p≤0.035).
","['high risk older adults', ""109 elderly fallers, 38 people with mild cognitive impairment (MCI) and 128 people with Parkinson's disease (PD""]",['treadmill training only or treadmill training combined with a virtual reality component'],"['Walking activity', 'walking activity (exposure to risk) and fall rates', 'falls risk', 'walking activity', 'FRA index', 'Free-living walking activity', 'fall rates, causing injuries and worse quality of life']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0086315', 'cui_str': 'FRAs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0034380'}]",109.0,0.021465,"Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p≤0.035).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Din', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Brook', 'Initials': 'B', 'LastName': 'Galna', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Neuromotor Rehabilitation Research Group, Belgium.'}, {'ForeName': 'Esther M J', 'Initials': 'EMJ', 'LastName': 'Bekkers', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Neuromotor Rehabilitation Research Group, Belgium.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pelosin', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health, University of Genova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Avanzino', 'Affiliation': 'Ospedale Policlinico San Martino-IRCCS, Genoa, Italy.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Nieuwhof', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cereatti', 'Affiliation': 'Department of Biomedical Sciences, Bioengineering Unit, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Della Croce', 'Affiliation': 'Department of Biomedical Sciences, Bioengineering Unit, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Laboratory for Early Markers of Neurodegeneration, Center for the study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Laboratory for Early Markers of Neurodegeneration, Center for the study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa007']
859,31532902,Determinants of blood telomere length in antiretroviral treatment-naïve HIV-positive participants enrolled in the NEAT 001/ANRS 143 clinical trial.,"OBJECTIVES


Our aim was to investigate factors associated with baseline blood telomere length in participants enrolled in NEAT 001/ANRS 143, a randomized, open-label trial comparing ritonavir-boosted darunavir (DRV/r) plus raltegravir (RAL) with DRV/r plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in antiretroviral therapy (ART)-naïve HIV-positive adults.
METHODS


A cross-sectional study of 201 randomly selected participants who had stored samples available was carried out. We measured telomere length (i.e. the relative telomere length, calculated as the telomere to single copy gene ratio) at baseline with monochrome quantitative multiplex polymerase chain reaction (PCR). We used multivariable predictive linear regression to calculate mean differences and 95% confidence intervals (CIs) for the association between baseline telomere length and baseline characteristics.
RESULTS


The baseline characteristics of the 201 participants did not differ from those of the 805 participants in the parent trial population: 89% were male, the mean age was 39 years, 83.6% were Caucasian, 93% acquired HIV infection via sexual transmission, the mean estimated time since HIV diagnosis was 2.1 years, the mean HIV-1 RNA load was 4.7 log 10  HIV-1 RNA copies/mL, the mean nadir and baseline CD4 counts were 301 and 324 cells/μL, respectively, and the mean CD4:CD8 ratio was 0.4. In the univariate analysis, shorter telomere length was associated with older age (per 10 years) (P < 0.001), HIV-1 RNA ≥ 100 000 copies/mL (P = 0.001), CD4 count < 200 cells/μL (P = 0.037), lower CD4:CD8 ratio (P = 0.018), statin treatment (P = 0.004), and current alcohol consumption (P = 0.035). In the multivariable analysis, older age (P < 0.001) and HIV RNA ≥ 100 000 copies/mL (P = 0.054) were independently associated with shorter telomere length.
CONCLUSIONS


Both age and HIV RNA viral load correlated with shorter blood telomere length in untreated persons living with HIV. These results suggest that HIV infection and age have synergistic and independent impacts upon immunosenescence.",2019,"In the univariate analysis, shorter telomere length was associated with older age (per 10 years)","['participants enrolled in NEAT 001/ANRS 143', 'antiretroviral therapy (ART)-naïve HIV-positive adults', '201 participants did not differ from those of the 805 participants in the parent trial population: 89% were male, the mean age was 39\xa0years, 83.6% were Caucasian, 93% acquired HIV infection via sexual transmission, the mean estimated time since HIV diagnosis was 2.1\xa0years, the mean HIV-1 RNA load was 4.7 log 10  HIV-1', '201 randomly selected participants who had stored samples available was carried out', 'antiretroviral treatment-naïve HIV-positive participants enrolled in the NEAT 001/ANRS 143 clinical trial']","['ritonavir-boosted darunavir (DRV/r)\xa0plus raltegravir (RAL) with DRV', 'r plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC']","['mean nadir and baseline CD4 counts', 'HIV-1 RNA ≥', 'mean CD4:CD8 ratio', 'current alcohol consumption', 'lower CD4:CD8 ratio']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",805.0,0.363533,"In the univariate analysis, shorter telomere length was associated with older age (per 10 years)","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Alejos', 'Affiliation': 'Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stella-Ascariz', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Montejano', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rodriguez-Centeno', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schwimmer', 'Affiliation': 'INSERM, UMR 1219, Bordeaux Population Health Research Center, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Bernardino', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rodes', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Esser', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Goujard', 'Affiliation': 'Internal Medicine Unit, Bicêtre Hospital, APHP, Universitè Paris Sud, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sarmento-Castro', 'Affiliation': 'Porto Hospital Center, Department of Infectious Diseases, Hospital Joaquim Urbano Unit, Porto, Portugal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'De Miguel', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esteban-Cantos', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wallet', 'Affiliation': 'CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Infectious Diseases Department and CIC 1413, INSERM, CHU de Nantes, Nantes, France.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Hospital La Paz Institute for Health Research, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV medicine,['10.1111/hiv.12791']
860,31364228,"Prevention of type 2 diabetes in prediabetic patients by using functional olive oil enriched in oleanolic acid: The PREDIABOLE study, a randomized controlled trial.","AIM


To assess whether the regular intake of an oleanolic acid (OA)-enriched olive oil is effective in the prevention of diabetes.
METHODS


In the PREDIABOLE study, prediabetic individuals (impaired fasting glucose and impaired glucose tolerance) of both sexes (176 patients, aged 30-80 years) were randomized to receive 55 mL/day of OA-enriched olive oil (equivalent dose 30 mg OA/day) [intervention group (IG)] or the same oil not enriched [control group (CG)]. The main outcome was the incidence of new-onset type 2 diabetes in both groups.
RESULTS


Forty-eight new diabetes cases occurred, 31 in the CG and 17 in the IG. The multivariate-adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG compared with the CG. Intervention-related adverse effects were not reported.
CONCLUSIONS


The intake of OA-enriched olive oil reduces the risk of developing diabetes in prediabetic patients. The results of the PREDIABOLE study promote the use of OA in new functional foods and drugs for the prevention of diabetes in individuals at risk of developing it.",2019,"The multivariate-adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG compared with the CG.","['prediabetic patients by using functional olive oil enriched in oleanolic acid', 'prediabetic individuals (impaired fasting glucose and impaired glucose tolerance) of both sexes (176 patients, aged 30-80\u2009years', 'individuals at risk of developing it', 'prediabetic patients']","['oleanolic acid (OA)-enriched olive oil', 'intervention group (IG)] or the same oil not enriched [control group (CG', 'OA-enriched olive oil', 'OA', '55\u2009mL/day of OA-enriched olive oil (equivalent dose 30\u2009mg OA/day']","['incidence of new-onset type 2 diabetes', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028925', 'cui_str': 'Oleanolic Acid'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0028925', 'cui_str': 'Oleanolic Acid'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439446', 'cui_str': 'mL/day'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",176.0,0.0912063,"The multivariate-adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG compared with the CG.","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Rada', 'Affiliation': 'Department of Food and Health, Instituto de la Grasa, Spanish National Research Council (CSIC), Seville, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Guinda', 'Affiliation': 'Department of Food and Health, Instituto de la Grasa, Spanish National Research Council (CSIC), Seville, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Jiménez-Rodríguez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Cayuela', 'Affiliation': 'Department of Food and Health, Instituto de la Grasa, Spanish National Research Council (CSIC), Seville, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ángel-Lugo', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Vilches-Arenas', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Seville, Seville, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Gómez-Martín', 'Affiliation': 'Department of Family Medicine, Primary Health District Seville, Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ortega-Calvo', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Castellano', 'Affiliation': 'Department of Food and Health, Instituto de la Grasa, Spanish National Research Council (CSIC), Seville, Spain.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13838']
861,31609077,"Efficacy of anti-inflammatory moisturizer vs hydrophilic cream in elderly patients with moderate to severe xerosis: A split site, triple-blinded, randomized, controlled trial.","BACKGROUND


Xerosis is a common problem among the elderly, characterized by dry-scaling erythema, fissuring, or pruritus, which could be treated by anti-inflammatory moisturizers without side effects of steroids.
AIMS


We aimed to investigate the efficacy of anti-inflammatory moisturizer (MAS062D lotion) vs hydrophilic cream for the improvement of dry and barrier function skin in xerosis patients.
METHODS


A split site, triple-blinded, randomized, controlled trial was conducted in the elderly with moderate to severe xerosis, who received the 28-day twice daily application of MAS062D lotion and hydrophilic cream on the assigned shins. The evaluations on day 0, 14, and 28 were performed using clinical assessment, skin hydration by corneometer, transepidermal water loss (TEWL), and biometric assessment.
RESULTS


There were 24 Thai elderly patients, of whom 87.5% were female (mean age = 58.04 years and mean xerosis severity scale (XSS) = 4.83). Both treatments revealed similar statistically significant improvement in XSS (P < .001). Interestingly, MAS062D lotion-treated side remarkably showed improvement of skin hydration compared with hydrophilic-treated side for 26.86 ± 7.94 vs 25.84 ± 5.1, 41.24 ± 6.92 vs 20.96 ± 6.8, 50.49 ± 8.2 vs 21.75 ± 8.29 at baseline, day 14, and 28, respectively (P-value < .001). Moreover, MAS062D lotion significantly yielded greater decrease in TEWL measurement and more erythema improvement than hydrophilic cream (P-value < .001). No serious adverse effects were observed with either treatment.
CONCLUSION


The MAS062D lotion could potentially be an efficacious treatment for improvement of xerosis in the elderly, which is also safe and refrains from steroid side effects.",2020,Both treatments revealed similar statistically significant improvement in XSS (P < .001).,"['24 Thai elderly patients, of whom 87.5% were female (mean age\xa0', 'elderly with moderate to severe xerosis', 'xerosis patients', 'elderly patients with moderate to severe xerosis']","['anti-inflammatory moisturizer vs hydrophilic cream', 'anti-inflammatory moisturizer (MAS062D lotion) vs hydrophilic cream', 'hydrophilic cream', 'MAS062D lotion', 'MAS062D lotion and hydrophilic cream']","['clinical assessment, skin hydration by corneometer, transepidermal water loss (TEWL), and biometric assessment', 'XSS', 'serious adverse effects', 'skin hydration', 'mean xerosis severity scale', 'TEWL measurement and more erythema improvement']","[{'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}]","[{'cui': 'C0475370', 'cui_str': 'Hydrophilicity'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",24.0,0.0953704,Both treatments revealed similar statistically significant improvement in XSS (P < .001).,"[{'ForeName': 'Suparuj', 'Initials': 'S', 'LastName': 'Lueangarun', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Amphur Klongluang, Thailand.'}, {'ForeName': 'Bith', 'Initials': 'B', 'LastName': 'Soktepy', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Amphur Klongluang, Thailand.'}, {'ForeName': 'Therdpong', 'Initials': 'T', 'LastName': 'Tempark', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13183']
862,31613050,"The efficacy and safety of permethrin 2.5% with tea tree oil gel on rosacea treatment: A double-blind, controlled clinical trial.","BACKGROUND


Rosacea is a chronic skin condition that typically affects the face and it results in redness and inflammation. The main risk factors of this disease are Demodex folliculorum, living in the pilosebaceous units.
AIMS


To evaluate the efficacy and safty of permethrin 2.5% in combination with tea tree oil (TTO) topical gel versus placebo on Demodex density (Dd) and clinical manifestation using standard skin surface biopsy (SSSB) in rosacea patients.
PATIENT/METHODS


In this double-blind, randomized clinical trial, 47 papulopustular rosacea patients were enrolled, with 35 patients finishing the 12 weeks of treatment. Each patient used permethrin 2.5% with TTO on one side of the face and a placebo on the other, twice daily for 12 weeks. SSSB, photography and clinical rosacea scores according to National Rosacea Society, as well as adverse drug reaction (ADRs) were reported at the baseline, 2nd, 5th, 8th, and 12th weeks.
RESULTS


A total of 47 patients were enrolled with papulopustular rosacea, and 35 patients finished the study. The effects of permethrin 2.5% with TTO gel on mite density were significant at week 5, 8, 12 (P value = .001). Clinical features and global assessments showed papules, pustules and nontransient erythema had improvement in drug group after 12 weeks (P values <.05). The improvement of burning and stinging and dry appearance was greater than the placebo gel (P value <.05). Itching in placebo group was significantly more than other group (P value = .002).
CONCLUSION


Administration of permethrin 2.5% with TTO gel demonstrated good efficacy and safety in rosacea. This topical gel inhibited the inflammatory effects of rosacea and reduced Demodex mite.",2020,The improvement of burning and stinging and dry appearance was greater than the placebo gel (P value <.05).,"['47 patients were enrolled with papulopustular rosacea, and 35 patients finished the study', '47 papulopustular rosacea patients were enrolled, with 35 patients finishing the 12\xa0weeks of treatment', 'rosacea patients']","['permethrin', 'standard skin surface biopsy (SSSB', 'tea tree oil (TTO) topical gel versus\xa0placebo', 'TTO gel', 'permethrin 2.5% with tea tree oil gel', 'permethrin 2.5% with TTO', 'placebo', 'permethrin 2.5% with TTO gel']","['adverse drug reaction (ADRs', 'inflammatory effects of rosacea and reduced Demodex mite', 'efficacy and safety', 'papules, pustules and nontransient erythema', 'SSSB, photography and clinical rosacea scores', 'improvement of burning and stinging and dry appearance', 'Itching', 'mite density', 'efficacy and safety in rosacea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0216194', 'cui_str': 'Tea Tree Oil'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0323683', 'cui_str': 'Demodex (organism)'}, {'cui': 'C0026231', 'cui_str': 'Mites'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",47.0,0.413809,The improvement of burning and stinging and dry appearance was greater than the placebo gel (P value <.05).,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ebneyamin', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rajabi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Qomi', 'Affiliation': 'Active Pharmaceutical Ingredients Research Center (APIRC), Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Asgharian', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Azizian', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13177']
863,31099455,Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial.,"AIM


Although colorectal cancer (CRC) screening reduces mortality and morbidity the uptake in target populations is suboptimal. The aim was to assess whether adding a brief phone intervention to the usual invitation process increases participation in a CRC screening programme based in Catalonia.
METHOD


This was a non-blinded prospective randomized control study of patients eligible for their first CRC screening test (immunochemical faecal occult blood test). Between March and December 2017, 512 invitees (age range 50-69 years) were randomized to receiving either a brief informative phone call prior to receiving the standard screening invitation (letter and informative brochure) or the standard screening invitation alone. The primary outcome was participation in the screening programme at 6 months.
RESULTS


In all, 492/512 patients (54.7% women; 45.3% men) could be analysed (239/256 intervention group; 253/256 control group). On an intention to treat basis, the intervention group (55% women; 45% men) saw an 11% increase in the participation rate (51.05% vs 40.32%, P = 0.017). The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03). After adjusting for sex, age and geographic area, the benefit of the intervention remained statistically significant (adjusted OR 1.54, 95% CI 1.07-2.20).
CONCLUSION


Our data suggest that a brief, informative intervention by phone in addition to the usual invitation process is effective in increasing participation in a CRC screening programme. It may be a useful strategy to improve uptake in groups which are less likely to participate in CRC screening (clinicaltrials.gov NCT03082911).",2019,"The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03).","['population-based colorectal cancer screening programme', '492/512 patients (54.7% women; 45.3% men', 'Between March and December 2017, 512 invitees (age range 50-69 years', 'patients eligible for their first CRC screening test (immunochemical faecal occult blood test']","['brief phone intervention', 'brief informative phone call prior to receiving the standard screening invitation (letter and informative brochure) or the standard screening invitation alone']","['participation in the screening programme at 6\xa0months', 'participation rate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0613802,"The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Selva', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Torà', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pascual', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Espinàs', 'Affiliation': ""Catalan Cancer Plan, Catalan Health Government, Catalan Institute of Oncology, L'Hospitalet de Llobregat Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baré', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14707']
864,31133558,Boosting Learning Efficacy with Noninvasive Brain Stimulation in Intact and Brain-Damaged Humans.,"Numerous behavioral studies have shown that visual function can improve with training, although perceptual refinements generally require weeks to months of training to attain. This, along with questions about long-term retention of learning, limits practical and clinical applications of many such paradigms. Here, we show for the first time in female and male human participants that just 10 d of visual training coupled with transcranial random noise stimulation (tRNS) over visual areas causes dramatic improvements in visual motion perception. Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation. Notably, tRNS also boosted learning in patients with chronic cortical blindness, leading to recovery of motion processing in the blind field after just 10 d of training, a period too short to elicit enhancements with training alone. In sum, our results reveal a remarkable enhancement of the capacity for long-lasting plastic and restorative changes when a neuromodulatory intervention is coupled with visual training. SIGNIFICANCE STATEMENT  Our work demonstrates that visual training coupled with brain stimulation can dramatically reduce the training period from months to weeks, and lead to fast improvement in neurotypical subjects and chronic cortically blind patients, indicating the potential of our procedure to help restore damaged visual abilities for currently untreatable visual dysfunctions. Together, these results indicate the critical role of early visual areas in perceptual learning and reveal its capacity for long-lasting plastic changes promoted by neuromodulatory intervention.",2019,"Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation.","['female and male human participants', 'patients with chronic cortical blindness', 'intact and brain-damaged humans']",['visual training coupled with transcranial random noise stimulation (tRNS'],['visual motion perception'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0155320', 'cui_str': 'Blindness, Cortical'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026598', 'cui_str': 'Motion Perception'}]",,0.018975,"Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Herpich', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Melnick', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Agosta', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy.'}, {'ForeName': 'Krystel R', 'Initials': 'KR', 'LastName': 'Huxlin', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Duje', 'Initials': 'D', 'LastName': 'Tadin', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Battelli', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy, Lorella.Battelli@iit.it.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3248-18.2019']
865,30805958,Two-year follow-up of a randomised controlled trial to assess the sustainability of a school intervention to improve the implementation of a school-based nutrition policy.,"ISSUE ADDRESSED


School-based nutrition policies can have a positive effect on the school food environment. The primary aim of this study was to assess the primary school adherence to a mandatory state-wide healthy canteen policy 12 months after an effective multi-strategic implementation intervention concluded.
METHODS


Primary schools were randomised to (a) a 12-14 months multi-strategic intervention or (b) no-intervention (control). The intervention aimed to improve implementation of a state-wide canteen policy by encouraging schools to remove unhealthy food and beverages (classified as ''red'' or ''banned'') from canteen menus and replace with healthy items (classified as ''green''). No implementation support was provided to either group by the research team between the 12 and 24 months data collection period.
RESULTS


Seventy schools participated, of which 56 schools were assessed at 24-month follow-up. Intervention schools were less likely to have a menu which contained ''red/banned'' items at 24-month follow-up (RR = 2.28; 95% CI: 1.18-4.40; P = 0.01). Intervention schools, however, were not more likely than controls to have a menu which contained >50% ''green'' items at 24-month follow-up (RR = 1.29; 95% CI: 0.98-1.70; P = 0.10). Intervention schools were more likely to adhere to both policy components (no red/banned items and >50% green items on the menu) than control schools (RR = 2.61; 95% CI: 1.29-5.29; P = 0.006). Among intervention schools that were fully adherent to the policy following implementation support (12-month post baseline), all were also adherent at the 24-month follow-up.
CONCLUSION


The intervention was effective in achieving long-term school adherence to a state-wide canteen policy at 24-month follow-up. SO WHAT?: The findings suggest that sustained improvements in implementation of school nutrition policies is possible following a period (12 months) of comprehensive implementation support.",2019,The intervention was effective in achieving long-term school adherence to a state-wide canteen policy at 24-month follow-up.,"['Primary schools', 'Seventy schools participated, of which 56 schools were assessed at 24-month follow-up']","['multi-strategic intervention or (b) no-intervention (control', 'school intervention']",['effective in achieving long-term school adherence'],"[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",56.0,0.0485343,The intervention was effective in achieving long-term school adherence to a state-wide canteen policy at 24-month follow-up.,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Delaney', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Janssen', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Reynolds', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hollis', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.238']
866,29514306,"Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.","Background


The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence.
Methods


In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies.
Results


Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy.
Conclusions


High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings.
Clinical Trials Registration


NCT01375647.",2018,"Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%.",['unvaccinated children'],"['rotavirus vaccines', 'monovalent rotavirus vaccine']",['natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD'],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}]","[{'cui': 'C0020969', 'cui_str': 'Innate Immune Response'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.312255,"Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%.","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville.'}, {'ForeName': 'E Ross', 'Initials': 'ER', 'LastName': 'Colgate', 'Affiliation': 'Department of Medicine and Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Petri', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Medicine and Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}]",The Journal of infectious diseases,['10.1093/infdis/jix668']
867,31913324,Impact of an integrated mother-preterm infant intervention on birth hospitalization charges.,"OBJECTIVE


To examine whether the H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) intervention reduced birth hospitalization charges yielding net savings after adjusting for intervention costs.
STUDY DESIGN


One hundred and twenty-one mother-preterm infant dyads randomized to H-HOPE or a control group had birth hospitalization data. Neonatal intensive care unit costs were based on billing charges. Linear regression, propensity scoring and regression analyses were used to describe charge differences.
RESULTS


Mean H-HOPE charges were $10,185 lower than controls (p = 0.012). Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants. Cost savings increased as hospital charges increased. The mean intervention cost was $680 per infant.
CONCLUSIONS


Lower birth hospitalization charges and the net cost savings of H-HOPE infants support implementation of H-HOPE as the standard of care for preterm infants.",2020,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[""Preterm Infant's Environment"", 'One hundred and twenty-one mother-preterm infant dyads randomized to', 'preterm infants']","['H-HOPE', 'H-HOPE (Hospital to Home', 'integrated mother-preterm infant intervention']","['birth hospitalization data', 'mean intervention cost', 'Mean H-HOPE charges', 'birth hospitalization charges', 'Cost savings']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",121.0,0.0351533,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Vonderheid', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. vonde@uic.edu.'}, {'ForeName': 'Chang G', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0567-7']
868,31464063,Short-term fully closed-loop insulin delivery using faster insulin aspart compared with standard insulin aspart in type 2 diabetes.,"We evaluated the efficacy and safety of short-term fully closed-loop insulin delivery using faster versus standard insulin aspart in type 2 diabetes. Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of closed-loop insulin delivery with either faster or standard insulin aspart in a double-blind randomized crossover design. Basal-bolus regimen was replaced by model predictive control algorithm-directed insulin delivery based on sensor glucose levels. The primary outcome was time with plasma glucose in target range (5.6-10.0 mmol/L) and did not differ between treatments (mean difference [95% CI] 3.3% [-8.2; 1.7], P = 0.17). Mean glucose and glucose variability were comparable, as was time spent below and above target range. Hypoglycaemia (<3.5 mmol/L) occurred once with faster insulin aspart and twice with standard insulin aspart. Mean total insulin dose was higher with faster insulin aspart (mean difference [95% CI] 3.7 U [0.7; 6.8], P = 0.021). No episodes of severe hypoglycaemia or other serious adverse events occurred. In conclusion, short-term fully closed-loop in type 2 diabetes may require higher dose of faster insulin aspart compared with standard insulin aspart to achieve comparable glucose control.",2019,Hypoglycaemia (<3.5mmol/l) occurred once with faster insulin aspart and twice with standard insulin aspart.,"['type 2 diabetes', 'Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of']","['faster insulin aspart and twice with standard insulin aspart', 'standard insulin aspart', 'short-term fully closed-loop insulin delivery using faster versus standard insulin aspart', 'closed-loop insulin delivery with either faster or standard insulin aspart', 'insulin aspart']","['severe hypoglycaemia', 'Mean total insulin dose', 'time with plasma glucose in target range', 'Hypoglycaemia', 'efficacy and safety', 'Mean glucose and glucose variability']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",15.0,0.0666606,Hypoglycaemia (<3.5mmol/l) occurred once with faster insulin aspart and twice with standard insulin aspart.,"[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Semmo', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wertli', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13861']
869,31699150,The ACTIVE study protocol: apatinib or placebo plus gefitinib as first-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer (CTONG1706).,"BACKGROUND


Gefitinib, as the first epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC), has been proved to significantly improve the progression-free survival (PFS) in the first-line setting but suffers from resistance 7-10 months after treatment initiation. Apatinib (YN968D1), a potent vascular endothelial growth factor receptor (VEGFR) 2-TKI, specifically binds to VEGFR2 and leads to anti-angiogenetic and anti-neoplastic effect. Concurrent inhibition of VEGFR and EGFR pathways represents a rational approach to improve treatment responses and delay the onset of treatment resistance in EGFR-mutant NSCLC. This ACTIVE study aims to assess the combination of apatinib and gefitinib as a new treatment approach for EGFR-mutant NSCLC as a first-line setting.
METHODS


This multicenter, randomized, double-blind, placebo-controlled phase III study (NCT02824458) has been designed to assess the efficacy and safety of apatinib or placebo combined with gefitinib as a first-line treatment for patients with EGFR-mutant advanced NSCLC. A total of 310 patients with EGFR-mutation (19del or 21L858R), pathological stage IIIB to IV non-squamous NSCLC were to be enrolled. The primary endpoint is investigator assessment of PFS, and the secondary endpoints include independent radiological central (IRC)-confirmed PFS, overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to progressive disease (TTPD), duration of response (DoR), quality of life (QoL) and safety. The patients are randomized in a 1:1 ratio to receive gefitinib (250 mg, p.o. q.d.) plus apatinib (500 mg, p.o. q.d.) or gefitinib plus placebo, given until disease progression or intolerable adverse events. Exploratory biomarker analysis will be performed. This study is being conducted across China and comprises of 30 participating centers. Enrollment commenced in August 2017 and finished in December 2018, most of the patients are in the follow-up period.
ANTICIPATED OUTCOMES AND SIGNIFICANCE


The present study will be the first to evaluate the efficacy and safety profile of the combination of apatinib plus gefitinib as a first-line therapy for patients with EGFR-positive advanced non-squamous NSCLC. Importantly, this trial will provide comprehensive evidence on the treatment of EGFR-TKIs combined with antiangiogenic therapy. Trial registration Clinicaltrials.gov NCT02824458. Registered 23 June 2016.",2019,"2-TKI, specifically binds to VEGFR2 and leads to anti-angiogenetic and anti-neoplastic effect.","['310 patients with EGFR-mutation (19del or 21L858R), pathological stage IIIB to IV non-squamous NSCLC were to be enrolled', 'patients with EGFR-positive advanced non-squamous NSCLC', '30 participating centers', 'patients with EGFR-mutant advanced non-small cell lung cancer (CTONG1706', 'advanced non-small cell lung cancer (NSCLC', 'patients with EGFR-mutant advanced NSCLC']","['apatinib plus gefitinib', 'placebo combined with gefitinib', 'placebo', 'gefitinib (250\xa0mg, p.o. q.d.) plus apatinib (500\xa0mg, p.o. q.d.) or gefitinib plus placebo', 'apatinib and gefitinib', 'placebo plus gefitinib']","['progression-free survival (PFS', 'efficacy and safety', 'efficacy and safety profile', 'investigator assessment of PFS, and the secondary endpoints include independent radiological central (IRC)-confirmed PFS, overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to progressive disease (TTPD), duration of response (DoR), quality of life (QoL) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034380'}]",310.0,0.403411,"2-TKI, specifically binds to VEGFR2 and leads to anti-angiogenetic and anti-neoplastic effect.","[{'ForeName': 'Zhonghan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Shaodong', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China. zhangli6@mail.sysu.edu.cn.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong, P. R. China. zhaohy@sysucc.org.cn.'}]","Cancer communications (London, England)",['10.1186/s40880-019-0414-4']
870,31077610,Can Cognitive-Behavioral Therapy Be Optimized With Parent Psychoeducation? A Randomized Effectiveness Trial of Adolescents With Major Depression in Puerto Rico.,"This is a longitudinal randomized control trial on the impact of adding a parent psychoeducation intervention (TEPSI) as part of cognitive-behavioral therapy (CBT) for adolescents with Major Depressive Disorder (MDD) in a Puerto Rican sample. We tested the efficacy of adding 8 group sessions of TEPSI to 12 sessions of individual CBT on reducing depressive symptoms, MDD diagnosis, and improving family functioning. Participants (n = 121) were randomized to individual CBT with or without TEPSI. No main group effects were found for most patient domains including depression symptoms, as well as presence of adolescent's MDD diagnosis at posttreatment. Results did show a main effect of CBT over time for depression symptoms, suicide ideation, family criticism, and the presence of MDD diagnosis decreasing from pre- to postintervention. A year post treatment, almost 70% of adolescents in both conditions (CBT and CBT + TEPSI) remained in remission. A main effect was obtained for treatment in the adolescent's perception of familism and family emotional involvement. The primary hypothesis that family psychoeducation would optimize CBT for depression in adolescents was not supported. Both conditions yielded similar clinical end points. The culturally adapted CBT was found effective with Latino/a adolescents showing clinically significant improvements from pretreatment to posttreatment and remained stable at a 1-year follow-up. Regarding family outcomes, adolescents in CBT + TEPSI remained stable from pretreatment to posttreatment on family emotional involvement, while adolescents in CBT-alone showed an increase. The implication of these findings is discussed.",2019,The culturally adapted CBT was found effective with Latino/a adolescents showing clinically significant improvements from pretreatment to posttreatment and remained stable at a 1-year follow-up.,"['Adolescents With Major Depression in Puerto Rico', 'Participants (n\xa0', 'adolescents with Major Depressive Disorder (MDD) in a Puerto Rican sample']","['individual CBT with or without TEPSI', 'cognitive-behavioral therapy (CBT', 'TEPSI', 'parent psychoeducation intervention (TEPSI', 'CBT']","['depression symptoms, suicide ideation, family criticism, and the presence of MDD diagnosis', 'depression symptoms', 'depressive symptoms, MDD diagnosis, and improving family functioning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",121.0,0.0268033,The culturally adapted CBT was found effective with Latino/a adolescents showing clinically significant improvements from pretreatment to posttreatment and remained stable at a 1-year follow-up.,"[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bernal', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Rivera-Medina', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Cumba-Avilés', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Mae Lynn', 'Initials': 'ML', 'LastName': 'Reyes-Rodríguez', 'Affiliation': 'Department of Psychiatry, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sáez-Santiago', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Yovanska', 'Initials': 'Y', 'LastName': 'Duarté-Vélez', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Lelis', 'Initials': 'L', 'LastName': 'Nazario', 'Affiliation': 'University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodríguez-Quintana', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Rosselló', 'Affiliation': 'University of Puerto Rico, Rio Piedras Campus, San Juan, Puerto Rico.'}]",Family process,['10.1111/famp.12455']
871,31632709,Efficacy of water spray for evaporative cooling in athletes with spinal cord injury.,"Study design


Interventional crossover study.
Objective


Spinal cord injury (SCI) disrupts afferent input to the hypothalamus and impairs efferent vaso- and sudomotor output, especially in lesions above the sympathetic chain (T1-L2). In consequence, persons with SCI under heat stress experience impairment in the ability to dissipate heat proportional to the lesion level. Thermoregulatory dysfunction places an individual at high risk of hyperthermia, which can be life threatening, especially for athletes with SCI during exercise. Current evidence on therapeutic cooling techniques in athletes with SCI is limited, but basic physiologic and research data suggest water spray (WS) might be efficacious, particularly in athletes with tetraplegia (TP), who are most impaired in thermoregulation. The aim of this study was to evaluate the effect of WS on core temperature (Tc) during exercise in athletes with SCI.
Setting


Texas, USA.
Methods


Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a wheelchair intermittent sprint exercise for 90 min under two conditions: (1) WS application every 15 min and (2) control (C), without WS. Tc was measured every 15 min and was analyzed for the effect of group (TP, PP, and AB) and time. Change in Tc (ΔTc) was also compared between groups.
Results


ΔTc was significantly higher in TP vs. PP ( p  < 0.0001) and TP vs. AB ( p  < 0.0001) groups under C treatment. WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
Sponsorship


Texas chapter of the Paralyzed Veterans of America.",2019,"WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","['athletes with spinal cord injury', 'athletes with tetraplegia (TP', 'Sponsorship\n\n\nTexas chapter of the Paralyzed Veterans of America', 'Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a', 'athletes with SCI']","['water spray', 'wheelchair intermittent sprint exercise for 90\u2009min under two conditions: (1) WS application every 15\u2009min and (2) control (C), without WS']","['Change in Tc (ΔTc', 'Tc elevation', 'core temperature (Tc', 'TP vs. PP']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",11.0,0.0318801,"WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trbovich', 'Affiliation': '1Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Koek', 'Affiliation': '2Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': '3School of Health Professions, Physical Therapy Department, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0194-8']
872,31908251,The effects of preoperative point-of-care focused cardiac ultrasound in high-risk patients: study protocol for a prospective randomised controlled trial.,"INTRODUCTION


Perioperative mortality and morbidity remain substantial in acute surgery. Risk factors include known cardiovascular disease, but preoperative screening is insensitive to occult cardiopulmonary conditions. Focused cardiac ultrasound (FOCUS) can disclose both structural and functional cardiac disease and provides insight into the patient's haemodynamic status. This study aims to clarify whether preoperative FOCUS changes clinical outcomes in high-risk patients.
METHODS


This is a multi-centre, randomised, controlled, prospective study including patients ≥ 65 years of age scheduled for acute/emergency abdominal- or orthopaedic surgery. A total of 800 patients will be randomised to ± application of preoperative FOCUS. The primary endpoint is the proportion of patients admitted to hospital > 10 days or death within 30 days of surgery. The secondary endpoints include changes in the anaesthesia approach facilitated by FOCUS, biomarkers of organ function and perioperative complications.
CONCLUSIONS


The knowledge generated from this study may facilitate changes in the anaesthesia evaluation and decision process and, consequently, in the entire perioperative anaesthesia clinical practice. The study has the potential to reduce the risk of perioperative cardiopulmonary complications which directly implies improved patient outcome and reduced hospital costs.
FUNDING


The Research Fund of the Department of Anaesthesiology, Randers Regional Hospital, The Central Denmark Region's Medical Research Fund and the Hospital of Southern Jutland.
TRIAL REGISTRATION


NCT03501927.",2020,"The study has the potential to reduce the risk of perioperative cardiopulmonary complications which directly implies improved patient outcome and reduced hospital costs.
","['65 years of age scheduled for acute/emergency abdominal- or orthopaedic surgery', '800 patients', 'acute surgery', 'high-risk patients', 'patients ≥']","['preoperative point-of-care focused cardiac ultrasound', 'cardiac ultrasound (FOCUS']","['anaesthesia approach facilitated by FOCUS, biomarkers of organ function and perioperative complications', 'proportion of patients admitted to hospital > 10 days or death within 30 days of surgery']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1655737'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery (qualifier value)'}]",800.0,0.0786149,"The study has the potential to reduce the risk of perioperative cardiopulmonary complications which directly implies improved patient outcome and reduced hospital costs.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pallesen', 'Affiliation': ''}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bhavsar', 'Affiliation': ''}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Fjølner', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Krog', 'Affiliation': ''}, {'ForeName': 'Laima', 'Initials': 'L', 'LastName': 'Malachauskiené', 'Affiliation': ''}, {'ForeName': 'Skule Arnesen', 'Initials': 'SA', 'LastName': 'Bakke', 'Affiliation': ''}, {'ForeName': 'Mikkel Andreas Strømgaard', 'Initials': 'MAS', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Marianne Lauridsen', 'Initials': 'ML', 'LastName': 'Vang', 'Affiliation': ''}, {'ForeName': 'Jakob Keller', 'Initials': 'JK', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Michael Helbo', 'Initials': 'MH', 'LastName': 'Bøndergaard', 'Affiliation': ''}, {'ForeName': 'Thomas Damgaard', 'Initials': 'TD', 'LastName': 'Jessing', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Thee', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Mortensen', 'Affiliation': ''}, {'ForeName': 'Michael Bugge', 'Initials': 'MB', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Juhl-Olsen', 'Affiliation': 'peter.juhl-olsen@clin.au.dk.'}]",Danish medical journal,[]
873,31844649,Three different ways of training ultrasound student-tutors yield significant gains in tutee's scanning-skills.,"Aim:  Many medical universities rely these days on trained student tutors to enable faculty-wide undergraduate ultrasound training. However, there is neither consensus on an optimal method nor any developed and agreed standard in the training of these student tutors. Usually internships and courses are employed which have both a specific set of advantages and disadvantages. We conducted a prospective quasi-randomized study of assess the effects of three types of tutor training on the resulting improvement in scanning skills of their tutees.  Methods:  Three batches of student tutors were trained by a course only (C-group), by an internship only (I-group) or by a course and an internship (CI-group). The respective gains in ultrasound scanning skills of the tutees were measured prospectively. A total 75 of the 124 5 th  year medical students (60.5%) who attended the mandatory ultrasound course completed both pre- and post-exams on a voluntary basis. Within a limit of eight minutes and three images, they were asked to depict and label a maximum of 14 anatomical structures. Two blinded raters independently awarded two points for each label with an identifiable structure and one point for each label with a possibly identifiable structure.  Results:  In all three groups, the tutees improved significantly by more than doubling their pre-score results and comparably (Gains: C-group 9.19±5.73 points, p<.0001, I-group 9.77±4.81 points, p<.0001, CI-group 8.97±5.49 points, p<.0001).  Conclusion:  Student tutors, who were trained with a course or an internship or a course and an internship could teach scanning skills to 5th year medical students very effectively and with similar success.",2019,A total 75 of the 124 5 th  year medical students (60.5%) who attended the mandatory ultrasound course completed both pre- and post-exams on a voluntary basis.,"['Conclusion:  Student tutors, who were trained with a course or an internship or a course and an internship could teach scanning skills to 5th year medical students very effectively and with similar success', 'trained student tutors to enable faculty-wide undergraduate ultrasound training', 'A total 75 of the 124 5 th  year medical students (60.5%) who attended the mandatory ultrasound course completed both pre- and post-exams on a voluntary basis']","['internship only (I-group) or by a course and an internship (CI-group', 'tutor training']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}]","[{'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],1245.0,0.0439126,A total 75 of the 124 5 th  year medical students (60.5%) who attended the mandatory ultrasound course completed both pre- and post-exams on a voluntary basis.,"[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Celebi', 'Affiliation': 'PHV dialysis center, Waiblingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Griewatz', 'Affiliation': 'Competence Centre for University Teaching in Medicine, Baden-Württemberg, Tübingen, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Ilg', 'Affiliation': 'Eberhard-Karls University, Medical faculty, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'University Hospital Tübingen, Department of Internal Medicine VI, Tübingen, Germany.'}, {'ForeName': 'Reimer', 'Initials': 'R', 'LastName': 'Riessen', 'Affiliation': 'University Hospital Tübingen, Department of Internal Medicine VIII, Tübingen, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'University Hospital Tübingen, Department of Internal Medicine I, Tübingen, Germany.'}, {'ForeName': 'Nisar Peter', 'Initials': 'NP', 'LastName': 'Malek', 'Affiliation': 'University Hospital Tübingen, Department of Internal Medicine I, Tübingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pauluschke-Fröhlich', 'Affiliation': 'University Hospital Tübingen, Department of Gynecology, Tübingen, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Debove', 'Affiliation': 'University Hospital Bern, Department of Neurology, Bern, Switzerland.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Muller', 'Affiliation': 'James Cook University, Smithfield, Australia.'}, {'ForeName': 'Eckhart', 'Initials': 'E', 'LastName': 'Fröhlich', 'Affiliation': 'University Hospital Tübingen, Department of Internal Medicine I, Tübingen, Germany.'}]",GMS journal for medical education,['10.3205/zma001285']
874,31888742,"A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects.","BACKGROUND/OBJECTIVE


FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), in healthy subjects.
METHODS


This randomized, open-label, parallel-group, single SC-dose study was conducted in 195 healthy male and female subjects who were randomized 1:1:1 to receive FKB327 40 mg via PFS, AI, or vial. The primary pharmacokinetic (PK) parameters, areas under the serum concentration-time curve to the last detectable value (AUC 0-t ) and extrapolated to infinity (AUC 0-∞ ), and maximum concentration (C max ), were compared. Relative bioavailability was established if the ratio of geometric least squares (LS) means of the test product was within the predefined bioequivalence (BE) range of 0.80 to 1.25 of the RP for each comparison. Safety and immunogenicity were assessed.
RESULTS


The mean serum FKB327 concentration-time profiles appeared similar across all 3 presentations. AUC 0-t , AUC 0-∞ , and C max  were within the predefined BE range for PFS compared with vial, suggesting comparable bioavailability. AUC 0-∞  and C max  of AI compared with vial and PFS were fully contained within BE range, although the upper limit of 90% confidence intervals of the geometric LS means ratios for AUC 0-t  was slightly high. Treatment-emergent adverse events in all 3 groups were mild, with no new safety concern with FKB327 identified. Similar immunogenicity was observed among administrations.
CONCLUSION


Among all 3 delivery methods, PK characteristics, safety profiles, and immunogenicity were similar.
TRIAL REGISTRATION


EU Clinical Trials Registry EudraCTN2014-004469-26, registered October 14, 2014.",2019,"Treatment-emergent adverse events in all 3 groups were mild, with no new safety concern with FKB327 identified.","['healthy subjects', '195 healthy male and female subjects']","['FKB327 40\u2009mg via PFS, AI, or vial', 'single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial', 'FKB327']","['AUC 0-∞  and C max  of AI', 'PK characteristics, safety profiles, and immunogenicity', 'relative bioavailability of FKB327', 'AUC 0-t , AUC 0-∞ , and C max', 'Similar immunogenicity', 'primary pharmacokinetic (PK) parameters, areas under the serum concentration-time curve to the last detectable value (AUC 0-t ) and extrapolated to infinity (AUC 0-∞ ), and maximum concentration (C max ', 'Safety and immunogenicity', 'mean serum FKB327 concentration-time profiles', 'Relative bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1609474', 'cui_str': 'Prefilled Syringe'}, {'cui': 'C2984091', 'cui_str': 'Auto-Injector'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",195.0,0.124834,"Treatment-emergent adverse events in all 3 groups were mild, with no new safety concern with FKB327 identified.","[{'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Bush', 'Affiliation': 'Executive Medical Director, Global Head, Clinical Pharmacology Physicians Covance Clinical Research Unit Limited, Springfield House, Hyde Street, Leeds, LS2 9LH, UK. Jim.Bush@covance.com.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kawakami', 'Affiliation': 'Manager, Medical Document Group, Kyowa Hakko Kirin Co., Ltd Ohtemachi Financial City Grand Cube, 1-9-2 Ohtemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Muniz', 'Affiliation': 'Mylan Inc., 1000 Mylan Blvd. Canonsburg, Canonsburg, PA, 15317, USA.'}]",BMC pharmacology & toxicology,['10.1186/s40360-019-0376-9']
875,31904175,"The effect of oral hydrolyzed eggshell membrane on the appearance of hair, skin, and nails in healthy middle-aged adults: A randomized double-blind placebo-controlled clinical trial.","BACKGROUND


Many over the counter and consumer packaged goods are promoted to enhance the appearance of hair, skin, and nails for the consumer. Nutrition is a major factor in affecting the health and appearance of hair, skin, and nails. In addition to how one eats, dietary supplementation may play a role in overall health and in the physical appearance.
AIMS


It was the aim of this study to objectively and subjectively evaluate the impacts of a nutritional intervention as compared to placebo on the appearances of hair, skin, and nails in healthy middle-aged adults.
METHODS


Randomized, double-blind placebo-controlled study with 88 subjects randomized evenly to Study Product (BiovaBio™ 450 mg/d, n = 44) or Placebo (n = 44) for 12-weeks. Outcome tests included TrichoScan HD (hair), Canfield Visia ®  -CR (skin), modified FACE-Q (skin), and anchored Likert Scales (nails).
RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks. There were no observed subjective improvements for nails (appearance, strength or growth).
CONCLUSIONS


Oral supplementation of 450 mg/d hydrolyzed eggshell membrane for 12 weeks is associated with improvement in the appearance of facial skin and hair.",2020,"RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks.","['88 subjects randomized evenly to', 'healthy middle-aged adults']","['Study Product (BiovaBio™ 450\xa0mg', 'Placebo', 'nutritional intervention', 'placebo', 'oral hydrolyzed eggshell membrane']","['hair thickness, reduction in hair breakage and improvement in hair growth', 'appearances of hair, skin, and nails', 'facial skin appearance', 'appearance of hair, skin, and nails', 'subjective improvements for nails (appearance, strength or growth', 'TrichoScan HD (hair), Canfield Visia ®  -CR (skin), modified FACE-Q (skin), and anchored Likert Scales (nails', 'appearance of facial skin and hair']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521537', 'cui_str': 'Eggshell'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1112754', 'cui_str': 'Hair breakage'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C1286247', 'cui_str': 'Appearance of hair'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",,0.281269,"RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks.","[{'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Kalman', 'Affiliation': 'Health Professions Division, Department of Health and Human Performance, College of Health Care Sciences, Nova Southeastern University, Davie, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hewlings', 'Affiliation': 'Department of Human Environmental Studies, Central Michigan University, Mount Pleasant, MI, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13275']
876,31916605,Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,"BACKGROUND


Biliary fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic biliary drainage during hepatectomy on the occurrence of postoperative biliary fistula.
METHODS


This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of biliary fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed.
RESULTS


A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The biliary fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The biliary fistula risk was associated with the width and length of the hepatic cut surface.
CONCLUSION


This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing biliary fistula. The use of transcystic drainage during hepatectomy to prevent postoperative biliary fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).",2020,"There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000).","['2009 to 2016 in nine centres', '158 patients in the transcystic group and 149 in the control group', 'biliary fistula after partial hepatectomy by transcystic biliary drainage', '310 patients were randomized']","['hepatectomy', 'transcystic biliary drainage or no transcystic drainage (control', 'transcystic drainage during hepatectomy', 'transcystic biliary drainage during hepatectomy']","['biliary fistula rate', 'occurrence of biliary fistula', 'Median duration of hospital stay', 'biliary fistula risk', 'morbidity', 'mortality', 'morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005417', 'cui_str': 'Biliary Fistula'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy (procedure)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005417', 'cui_str': 'Biliary Fistula'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]",158.0,0.238085,"There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maulat', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Buc', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Hôtel Dieu, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Boleslawski', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Claude Huriez Hospital, Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Belghiti', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hardwigsen', 'Affiliation': 'Department of Digestive Surgery, La Conception University Hospital, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vibert', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Centre Hépato-Biliaire, Paul Brousse Hospital, Villejuif, France.'}, {'ForeName': 'J-R', 'Initials': 'JR', 'LastName': 'Delpero', 'Affiliation': 'Department of Digestive Surgery, Paoli Calmettes Institute, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': 'Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arnaud', 'Affiliation': 'Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Suc', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pessaux', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, IRCAD, Strasbourg, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}]",The British journal of surgery,['10.1002/bjs.11405']
877,31573450,Lessons learned from the pilot study of an orthostatic hypotension intervention in the subacute phase following spinal cord injury.,"Context : Following spinal cord injury (SCI) at the cervical or upper-thoracic level, orthostatic hypotension (OH) is observed in 13-100% of patients. This study aimed to test the feasibility of conducting a randomized controlled trial combining a dynamic tilt-table (Erigo ® ) and functional electrical stimulation (FES) to mitigate OH symptoms in the subacute phase after SCI.  Design : Pilot study.  Setting : A tertiary rehabilitation hospital.  Participants : Inpatients who had a C4-T6 SCI (AIS A-D) less than 12 weeks before recruitment, and reported symptoms of OH in their medical chart.  Interventions : Screening sit-up test to determine eligibility, then 1 assessment session and 3 intervention sessions with Erigo ®  and FES for eligible participants.  Outcome measures : Recruitment rate, duration of assessment and interventions, resources used, blood pressure, and Calgary Presyncope Form (OH symptoms).  Results : Amongst the 232 admissions, 148 inpatient charts were reviewed, 11 inpatients met all inclusion criteria, 7 participated in a screening sit-up test, and 2 exhibited OH. Neither of the two participants recruited in the pilot study was able to fully complete the assessment and intervention sessions due to scheduling issues (i.e. limited available time).  Conclusion : This pilot study evidenced the non-feasibility of the clinical trial as originally designed, due to the low recruitment rate and the lack of available time for research in participant's weekday schedule. OH in the subacute phase after SCI was less prevalent and less incapacitating than expected. Conventional management and spontaneous resolution of symptoms appeared sufficient to mitigate OH in most patients with subacute SCI.",2019,Neither of the two participants recruited in the pilot study was able to fully complete the assessment and intervention sessions due to scheduling issues (i.e. limited available time).  ,"['Participants : Inpatients who had a C4-T6 SCI (AIS A-D) less than 12 weeks before recruitment, and reported symptoms of OH in their medical chart', 'patients with subacute SCI', 'Amongst the 232 admissions, 148 inpatient charts were reviewed, 11 inpatients met all inclusion criteria, 7 participated in a screening sit-up test, and 2 exhibited OH']","['orthostatic hypotension intervention', 'dynamic tilt-table (Erigo ® ) and functional electrical stimulation (FES']","['orthostatic hypotension (OH', 'Recruitment rate, duration of assessment and interventions, resources used, blood pressure, and Calgary Presyncope Form (OH symptoms']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0560837', 'cui_str': 'Does sit up (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}]","[{'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0674267', 'cui_str': 'greigite'}]","[{'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",232.0,0.0570888,Neither of the two participants recruited in the pilot study was able to fully complete the assessment and intervention sessions due to scheduling issues (i.e. limited available time).  ,"[{'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Moineau', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Brisbois', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Zivanovic', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Masae', 'Initials': 'M', 'LastName': 'Miyatani', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Naaz', 'Initials': 'N', 'LastName': 'Kapadia', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}, {'ForeName': 'Jane T C', 'Initials': 'JTC', 'LastName': 'Hsieh', 'Affiliation': ""Lawson Health Research Institute, St. Joseph's Health Care , London.""}, {'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Popovic', 'Affiliation': 'KITE, Toronto Rehabilitation Institute - University Health Network , Toronto , Ontario , Canada.'}]",The journal of spinal cord medicine,['10.1080/10790268.2019.1638129']
878,31895201,Parental Knowledge of Appropriate Placement of Child Restraint Systems Before and After Educational Intervention in a Pediatric Emergency Department.,"OBJECTIVE


This study aimed to determine caregiver's knowledge of appropriate car restraint systems (CRSs) use and compare this with the actual use among children presenting to the pediatric emergency department (PED), and to determine the efficacy of PED-based intervention on improving knowledge.
METHODS


We conducted a prospective, intervention study of children (<8 years old) during a 12-month period in the PED. Based on their height and weight, children were assigned to group 1 (rear facing), group 2 (forward facing), or group 3 (booster). Caregivers were surveyed in their baseline CRS knowledge. Certified child passenger safety technicians evaluated each CRS and gave caregivers one-on-one education. Participants were called back to answer a posttest to determine if the information given was retained.
RESULTS


Of the 170 children enrolled, 64 (37.6%) were assigned to group 1, 68 (40%) to group 2, and 38 (22.3%) to group 3. Of these, 63% were not aware of the state law regarding CRS use. Among those without a CRS, 18% belonged to group 1, 36% to group 2, and 46% to group 3. Even among those who reportedly had CRS, 13% of children did not have one-on-on inspection. After inspection, 84% of group 1, 71% of group 2, and 70% of group 3 were in the appropriate one. Nearly 45% were not compliant with American Academy of Pediatrics guidelines of children riding in rear-facing CRS until 2 years of age.
CONCLUSIONS


A significant proportion of children visiting the PED are not in appropriate CRS, and caretaker knowledge about correct CRS types and installation is poor. Future educational efforts should focus on rear-facing and booster seat age-group children.",2020,"RESULTS


Of the 170 children enrolled, 64 (37.6%) were assigned to group 1, 68 (40%) to group 2, and 38 (22.3%) to group 3.","['children (<8 years old) during a 12-month period in the PED', '170 children enrolled, 64 (37.6', 'children presenting to the pediatric emergency department (PED']","['appropriate car restraint systems (CRSs', 'Child Restraint Systems']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}]",[],170.0,0.0300005,"RESULTS


Of the 170 children enrolled, 64 (37.6%) were assigned to group 1, 68 (40%) to group 2, and 38 (22.3%) to group 3.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Perez', 'Affiliation': ""From the Nemours Children's Hospital, Orlando, FL.""}, {'ForeName': 'Marwan A', 'Initials': 'MA', 'LastName': 'Zidan', 'Affiliation': 'Statistics Department, United Arab Emirates University, Al-Ain, United Arab Emirates.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Sethuraman', 'Affiliation': ""Carman and Ann Adams Department of Pediatrics, Wayne State University, Children's Hospital of Michigan, Detroit, MI.""}]",Pediatric emergency care,['10.1097/PEC.0000000000002020']
879,31625947,A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis.,"BACKGROUND


A self-administered Web-based intervention was developed to help carers of persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC) deal with the significant transitions they experience. The intervention, My Tools 4 Care (MT4C), was evaluated during a pragmatic mixed methods randomized controlled trial with 199 carers. Those in the intervention group received free, password-protected access to MT4C for three months. MT4C was found to increase hope in participants at three months compared with the control group. However, in the intervention group, 22% (20/92) did not use MT4C at all during the three-month period.
OBJECTIVE


This mixed methods secondary analysis aimed to (1) examine differences at three months in the outcomes of hope, self-efficacy, and health-related quality of life (HRQOL) scores in users (ie, those who used MT4C at least once during the three-month period) compared with nonusers and (2) identify reasons for nonuse.
METHODS


Data from the treatment group of a pragmatic mixed methods randomized controlled trial were used. Through audiotaped telephone interviews, trained research assistants collected data on participants' hope (Herth Hope Index; HHI), self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL (Short-Form 12-item health survey version 2; SF-12v2) at baseline, one month, and three months. Treatment group participants also provided feedback on MT4C through qualitative telephone interviews at one month and three months. Analysis of covariance was used to determine differences at three months, and generalized estimating equations were used to determine significant differences in HHI, GSES, and SF-12v2 between users and nonusers of MT4C from baseline to three months. Interview data were analyzed using content analysis and integrated with quantitative data at the result stage.
RESULTS


Of the 101 participants at baseline, 9 (9%) withdrew from the study, leaving 92 participants at three months of which 72 (78%) used MT4C at least once; 20 (22%) participants did not use it at all. At baseline, there were no statistically significant differences in demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score) between users and nonusers. At three months, participants who used MT4C at least once during the three-month period (users) reported higher mean GSES scores (P=.003) than nonusers. Over time, users had significantly higher GSES scores than nonusers (P=.048). Reasons for nonuse of MT4C included the following: caregiving demands, problems accessing MT4C (poor connectivity, computer literacy, and navigation of MT4C), and preferences (for paper format or face-to-face interaction).
CONCLUSIONS


Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC. Future research with MT4C should consider including educational programs for computer literacy and providing alternate ways to access MT4C in addition to Web-based access.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387.",2019,"CONCLUSIONS


Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC.","['users', 'Carers of Older Persons With Alzheimer Disease and Related Dementias', 'persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC']","['MT4C', 'Web-Based Intervention']","['hope, self-efficacy, and health-related quality of life (HRQOL) scores', 'GSES scores', 'self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL ', 'demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score', 'mean GSES scores', 'HHI, GSES, and SF-12v2']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",101.0,0.122176,"CONCLUSIONS


Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Duggleby', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kathya', 'Initials': 'K', 'LastName': 'Jovel Ruiz', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Cancer Care, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'School of Geography and Earth Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Triscott', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swindle', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}]",Journal of medical Internet research,['10.2196/14254']
880,31625949,"A Protocol-Driven, Bedside Digital Conversational Agent to Support Nurse Teams and Mitigate Risks of Hospitalization in Older Adults: Case Control Pre-Post Study.","BACKGROUND


Hospitalized older adults often experience isolation and disorientation while receiving care, placing them at risk for many inpatient complications, including loneliness, depression, delirium, and falls. Embodied conversational agents (ECAs) are technological entities that can interact with people through spoken conversation. Some ECAs are also relational agents, which build and maintain socioemotional relationships with people across multiple interactions. This study utilized a novel form of relational ECA, provided by Care Coach (care.coach, inc): an animated animal avatar on a tablet device, monitored and controlled by live health advocates. The ECA implemented algorithm-based clinical protocols for hospitalized older adults, such as reorienting patients to mitigate delirium risk, eliciting toileting needs to prevent falls, and engaging patients in social interaction to facilitate social engagement. Previous pilot studies of the Care Coach avatar have demonstrated the ECA's usability and efficacy in home-dwelling older adults. Further study among hospitalized older adults in a larger experimental trial is needed to demonstrate its effectiveness.
OBJECTIVE


The aim of the study was to examine the effect of a human-in-the-loop, protocol-driven relational ECA on loneliness, depression, delirium, and falls among diverse hospitalized older adults.
METHODS


This was a clinical trial of 95 adults over the age of 65 years, hospitalized at an inner-city community hospital. Intervention participants received an avatar for the duration of their hospital stay; participants on a control unit received a daily 15-min visit from a nursing student. Measures of loneliness (3-item University of California, Los Angeles Loneliness Scale), depression (15-item Geriatric Depression Scale), and delirium (confusion assessment method) were administered upon study enrollment and before discharge.
RESULTS


Participants who received the avatar during hospitalization had lower frequency of delirium at discharge (P<.001), reported fewer symptoms of loneliness (P=.01), and experienced fewer falls than control participants. There were no significant differences in self-reported depressive symptoms.
CONCLUSIONS


The study findings validate the use of human-in-the-loop, relational ECAs among diverse hospitalized older adults.",2019,"RESULTS


Participants who received the avatar during hospitalization had lower frequency of delirium at discharge (P<.001), reported fewer symptoms of loneliness (P=.01), and experienced fewer falls than control participants.","['Hospitalized older adults', 'home-dwelling older adults', 'hospitalized older adults', 'Older Adults', 'diverse hospitalized older adults', '95 adults over the age of 65 years, hospitalized at an inner-city community hospital']","['Care Coach avatar', 'human-in-the-loop, protocol-driven relational ECA', 'Embodied conversational agents (ECAs']","['loneliness, depression, delirium, and falls', 'self-reported depressive symptoms', ""ECA's usability and efficacy"", 'symptoms of loneliness', 'frequency of delirium at discharge', 'loneliness (3-item University of California, Los Angeles Loneliness Scale), depression (15-item Geriatric Depression Scale), and delirium (confusion assessment method']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0222045'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",95.0,0.0583494,"RESULTS


Participants who received the avatar during hospitalization had lower frequency of delirium at discharge (P<.001), reported fewer symptoms of loneliness (P=.01), and experienced fewer falls than control participants.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bott', 'Affiliation': 'Clinical Excellence Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wexler', 'Affiliation': 'Pace University, New York, NY, United States.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Drury', 'Affiliation': 'Pace University, New York, NY, United States.'}, {'ForeName': 'Chava', 'Initials': 'C', 'LastName': 'Pollak', 'Affiliation': 'Pace University, New York, NY, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Wang', 'Affiliation': 'Care.Coach, Millbrae, CA, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Scher', 'Affiliation': 'Jamaica Hospital Medical Center, New York, NY, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Narducci', 'Affiliation': 'Jamaica Hospital Medical Center, New York, NY, United States.'}]",Journal of medical Internet research,['10.2196/13440']
881,30415637,Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer.,"BACKGROUND


Higher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n-3 fatty acids has such effects in general populations at usual risk for these end points is unclear.
METHODS


We conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D 3  (at a dose of 2000 IU per day) and marine n-3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type. Secondary end points included individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer. Safety was also assessed. This article reports the results of the comparison of n-3 fatty acids with placebo.
RESULTS


A total of 25,871 participants, including 5106 black participants, underwent randomization. During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24). Invasive cancer was diagnosed in 820 participants in the n-3 group and in 797 in the placebo group (hazard ratio, 1.03; 95% CI, 0.93 to 1.13; P=0.56). In the analyses of key secondary end points, the hazard ratios were as follows: for the expanded composite end point of cardiovascular events, 0.93 (95% CI, 0.82 to 1.04); for total myocardial infarction, 0.72 (95% CI, 0.59 to 0.90); for total stroke, 1.04 (95% CI, 0.83 to 1.31); for death from cardiovascular causes, 0.96 (95% CI, 0.76 to 1.21); and for death from cancer (341 deaths from cancer), 0.97 (95% CI, 0.79 to 1.20). In the analysis of death from any cause (978 deaths overall), the hazard ratio was 1.02 (95% CI, 0.90 to 1.15). No excess risks of bleeding or other serious adverse events were observed.
CONCLUSIONS


Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).",2019,"CONCLUSIONS


Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo.","['820 participants in the n-3 group and in 797 in the', 'A total of 25,871 participants, including 5106 black participants, underwent randomization', 'cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States']","['vitamin D', 'marine n-3 fatty acids', 'Marine n-3 Fatty Acids', 'placebo', 'n-3 fatty acids with placebo', 'fatty acids', 'marine n-3 (also called omega-3', 'n-3 fatty acids']","['Invasive cancer', 'major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type', 'total stroke', 'excess risks of bleeding or other serious adverse events', 'hazard ratio', 'hazard ratios', 'total myocardial infarction', 'individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer', 'Safety', 'major cardiovascular event']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25871.0,0.647762,"CONCLUSIONS


Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo.","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Christen', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Gibson', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Albert', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Copeland', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': ""D'Agostino"", 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ridge', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1811403']
882,31815677,Effectiveness of Smartphone App-Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial.,"BACKGROUND


In recent years, the rapid development of mobile medical technology has provided multiple ways for the long-term management of chronic diseases, especially diabetes. As a new type of management model, smartphone apps are global, convenient, cheap, and interactive. Although apps were proved to be more effective at glycemic control, compared with traditional computer- and Web-based telemedicine technologies, how to gain a further and sustained improvement is still being explored.
OBJECTIVE


The objective of this study was to investigate the effectiveness of an app-based interactive management model by a professional health care team on glycemic control in Chinese patients with poorly controlled diabetes.
METHODS


This study was a 6-month long, single-center, prospective randomized controlled trial. A total of 276 type 1 or type 2 diabetes patients were enrolled and randomized to the control group (group A), app self-management group (group B), and app interactive management group (group C) in a 1:1:1 ratio. The primary outcome was the change in glycated hemoglobin (HbA 1c ) level. Missing data were handled by multiple imputation.
RESULTS


At months 3 and 6, all 3 groups showed significant decreases in HbA 1c  levels (all P<.05). Patients in the app interactive management group had a significantly lower HbA 1c level than those in the app self-management group at 6 months (P=.04). The average HbA 1c  reduction in the app interactive management group was larger than that in the app self-management and control groups at both months 3 and 6 (all P<.05). However, no differences in HbA 1c  reduction were observed between the app self-management and control groups at both months 3 and 6 (both P>.05). Multivariate line regression analyses also showed that the app interactive management group was associated with the larger reduction of HbA 1c  compared with groups A and B at both months 3 and 6 (all P>.05). In addition, the app interactive management group had better control of triglyceride and high-density lipoprotein cholesterol levels at both months 3 and 6 compared with baseline (both P<.05).
CONCLUSIONS


In Chinese patients with poorly controlled diabetes, it was difficult to achieve long-term effective glucose improvement by using app self-management alone, but combining it with interactive management can help achieve rapid and sustained glycemic control.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02589730; https://clinicaltrials.gov/ct2/show/NCT02589730.",2019,Patients in the app interactive management group had a significantly lower HbA 1c level than those in the app self-management group at 6 months (P=.04).,"['Chinese patients with poorly controlled diabetes', 'Chinese Patients With Poorly Controlled Diabetes', 'A total of 276 type 1 or type 2 diabetes patients']","['app self-management group (group B), and app interactive management group', 'Smartphone App-Based Interactive Management', 'app-based interactive management model by a professional health care team']","['change in glycated hemoglobin (HbA 1c ) level', 'control of triglyceride and high-density lipoprotein cholesterol levels', 'HbA 1c level', 'HbA 1c  levels', 'HbA 1c  reduction', 'average HbA 1c  reduction']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",276.0,0.0298292,Patients in the app interactive management group had a significantly lower HbA 1c level than those in the app self-management group at 6 months (P=.04).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Haoyong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jiemin', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Journal of medical Internet research,['10.2196/15401']
883,31846923,Efficacy of Epley Maneuver on Quality of Life of Elderly Patients with Subjective BPPV.,"OBJECTIVES


This study aimed to evaluate the efficacy of the repositioning maneuver on quality of life in elderly patients with dizziness and/or vertigo.
MATERIALS AND METHODS


This controlled, prospective randomized clinical trial was conducted in elderly patients aged 65 years and above with a positive history of benign paroxysmal positional vertigo (BPPV), presence of vertigo, and no observable nystagmus during the Dix-Hallpike test, so-called Subjective BPPV (S-BPPV). Individuals were evaluated by visual analog scale (VAS) and dizziness handicap inventory (DHI). Groups were defined as treatment (treated with Epley maneuver bilaterally) or no treatment control (no treatment modality or canalith repositioning maneuver). Ten days after the first assessment, all patients were reassessed using VAS and DHI.
RESULTS


A total of 50 patients were randomized into two groups: 25 to the treatment group, and 25 to the control group. No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively). On the other hand, after the reassessment, VAS and total DHI scores were both significantly reduced in the treatment group (p<0.001, p<0.001, respectively), but no reduction in either score was found in the control group (p=0.216, p=0.731, respectively).
CONCLUSION


This study showed that elderly patients with S-BPPV benefit from the Epley maneuver, in particular global and disease-specific quality of life.",2019,"No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively).","['elderly patients aged 65 years and above with a positive history of benign paroxysmal positional vertigo (BPPV), presence of vertigo, and no observable nystagmus during the Dix-Hallpike test, so-called Subjective BPPV (S-BPPV', 'A total of 50 patients', 'elderly patients with S-BPPV', 'Elderly Patients with Subjective BPPV', 'elderly patients with dizziness and/or vertigo']","['repositioning maneuver', 'Epley Maneuver', 'Epley maneuver bilaterally) or no treatment control (no treatment modality or canalith repositioning maneuver']","['visual analog scale (VAS) and dizziness handicap inventory (DHI', 'baseline VAS and total DHI scores', 'Quality of Life', 'VAS and total DHI scores', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C1279393', 'cui_str': 'Epley maneuver (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}]",,0.0369224,"No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively).","[{'ForeName': 'Uzdan', 'Initials': 'U', 'LastName': 'Uz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Uz', 'Affiliation': 'Department of Neurology, Dokuz Eylül University School of Medicine, İzmir, Turkey.'}, {'ForeName': 'Gülden', 'Initials': 'G', 'LastName': 'Akdal', 'Affiliation': 'Department of Neurology, Dokuz Eylül University School of Medicine, İzmir, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Çelik', 'Affiliation': 'Department Otolaryngology-Head and Neck Surgery, Manisa Celal Bayar University School of Medicine, Manisa, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.6483']
884,31123001,Personalised antiplatelet therapy based on pharmacogenomics in acute ischaemic minor stroke and transient ischaemic attack: study protocol for a randomised controlled trial.,"INTRODUCTION


Antiplatelet therapy combining aspirin and clopidogrel is considered to be a key intervention for acute ischaemic minor stroke (AIMS) and transient ischaemic attack (TIA). However, the interindividual variability in response to clopidogrel resulting from the polymorphisms in clopidogrel metabolism-related genes has greatly limited its efficacy. To date, there are no reports on individualised antiplatelet therapy for AIMS and TIA based on the genetic testing and clinical features. Therefore, we conduct this randomised controlled trial to validate the hypothesis that the individualised antiplatelet therapy selected on the basis of a combination of genetic information and clinical features would lead to better clinical outcomes compared with the standard care based only on clinical features in patients with AIMS or TIA.
METHODS AND ANALYSIS


This trial will recruit 2382 patients with AIMS or TIA who meet eligibility criteria. Patients are randomly assigned in a 1:1 ratio to pharmacogenetic group and standard group. Both groups receive a loading dose of 300 mg aspirin and 300 mg clopidogrel on day 1, followed by 100 mg aspirin per day on days 2-365. The P2Y12 receptor antagonist is selected by the clinician according to the genetic information and clinical features for pharmacogenetic group and clinical features for the standard group on days 2-21. The primary efficacy endpoint is a new stroke event (ischaemic or haemorrhagic) that happens within 1 year. The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death). Baseline characteristics and outcomes after treatment will be evaluated.
ETHICS AND DISSEMINATION


This protocol has been approved by the ethics committee of Yangpu Hospital, Tongji University School of Medicine (No. LL-2018-KY-012). We will submit the results of this trial for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ChiCTR1800019911; Pre-results.",2019,"The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death).","['patients with AIMS or TIA', 'acute ischaemic minor stroke and transient ischaemic attack', '2382 patients with AIMS or TIA who meet eligibility criteria']","['clopidogrel', 'aspirin and clopidogrel', 'aspirin', 'Personalised antiplatelet therapy']","['new stroke event (ischaemic or haemorrhagic) that happens within 1\u2009year', 'individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2382.0,0.166346,"The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death).","[{'ForeName': 'Xiao-Guang', 'Initials': 'XG', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiao-Qiong', 'Initials': 'XQ', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhi-Zhang', 'Initials': 'ZZ', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hua-Yu', 'Initials': 'HY', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yun-Hua', 'Initials': 'YH', 'LastName': 'Yue', 'Affiliation': 'Department of Neurology, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}]",BMJ open,['10.1136/bmjopen-2018-028595']
885,31882606,The effect of mindfulness training on extinction retention.,"Anxiety and trauma related disorders are highly prevalent, causing suffering and high costs for society. Current treatment strategies, although effective, only show moderate effect-sizes when compared to adequate control groups demonstrating a need to develop new forms of treatment or optimize existing ones. In order to achieve this, an increased understanding of what mechanisms are involved is needed. An emerging literature indicates that mindfulness training (MFT) can be used to treat fear and anxiety related disorders, but the treatment mechanisms are unclear. One hypothesis, largely based on findings from neuroimaging studies, states that MFT may improve extinction retention, but this has not been demonstrated empirically. To investigate this question healthy subjects either completed a 4-week MFT- intervention delivered through a smart-phone app (n = 14) or were assigned to a waitlist (n = 15). Subsequently, subjects participated in a two-day experimental protocol using pavlovian aversive conditioning, evaluating acquisition and extinction of threat-related responses on day 1, and extinction retention on day 2. Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2. MFT did not however, have an effect on either the acquisition or extinction of conditioned responses day 1. This clarifies the positive effect of MFT on emotional functioning and could have implications for the treatment of anxiety and trauma related disorders.",2019,"Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2.",['question healthy subjects either completed a 4-week'],"['mindfulness training', 'MFT', 'mindfulness training (MFT', 'MFT- intervention delivered through a smart-phone app']","['spontaneous recovery of threat related arousal responses', 'extinction retention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.0144693,"Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Björkstrand', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark. johannes.bjorkstrand@psyk.uu.se.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schiller', 'Affiliation': 'Departments of Psychiatry and Neuroscience, and Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Rosén', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kirk', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-019-56167-7']
886,31122997,"'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination.","INTRODUCTION


Increasing numbers of children are failing to receive many recommended vaccines, which has led to significant outbreaks of vaccine-preventable diseases in the USA and worldwide. A major driver of undervaccination is parental vaccine hesitance. Prior research demonstrates that mothers are the primary decision maker for infant vaccination, and that their vaccination attitudes form primarily during pregnancy and early in their infant's life.
METHODS AND ANALYSIS


This manuscript describes the protocol for an ongoing three-armed randomised controlled trial done at Kaiser Permanente Colorado (KPCO). The trial aims to test the efficacy of provided tailored, individualised information via the Internet to pregnant and new mothers versus untailored information versus usual care on the timeliness of infant vaccination. The primary outcome to be assessed is vaccination status, which is a dichotomous outcome (up to date vs not) assessed at age 200 days, reflecting the time when infants should have completed the first set of vaccine provided (at age 2, 4 and 6 months). Infants with one or more age-appropriate recommended vaccines at least 30 days delayed are categorised as not up to date whereas all other infants are considered up to date. Secondary outcomes include vaccination status at age 489 days, reflecting receipt of recommended vaccines at age 12-15 months, as well as vaccination attitudes, hesitancy and intention. Vaccination data will be derived from the electronic medical record and the state immunisation registry. Other secondary outcomes will be assessed by online surveys.
ETHICS AND DISSEMINATION


The study activities were approved by the Institutional Review Boards of the University of Colorado, KPCO and the University of Michigan. Results will be disseminated through peer-reviewed manuscripts and conference presentations.
TRIAL REGISTRATION NUMBER


NCT02665013; Pre-results.",2019,"The trial aims to test the efficacy of provided tailored, individualised information via the Internet to pregnant and new mothers versus untailored information versus usual care on the timeliness of infant vaccination.",['Kaiser Permanente Colorado (KPCO'],['educational intervention'],"['Reducing Delays', 'timeliness of infant vaccination', 'vaccination status at age 489 days, reflecting receipt of recommended vaccines at age 12-15 months, as well as vaccination attitudes, hesitancy and intention']","[{'cui': 'C0009399', 'cui_str': 'Colorado'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1443394', 'cui_str': 'Vaccination status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.200583,"The trial aims to test the efficacy of provided tailored, individualised information via the Internet to pregnant and new mothers versus untailored information versus usual care on the timeliness of infant vaccination.","[{'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente, Denver, Colorado, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Health Education and Health Behavior, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cataldi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA.'}]",BMJ open,['10.1136/bmjopen-2018-027968']
887,31860366,A week-long outpatient induction onto XR-naltrexone in patients with opioid use disorder.,"BACKGROUND


Extended-release (XR) naltrexone can prevent relapse to opioid use disorder following detoxification. However, one of the barriers to initiating XR-naltrexone is the recommendation for a 7-10-day period of abstinence from opioids prior to the first dose.
OBJECTIVES


The current study evaluated the feasibility of an XR-naltrexone induction protocol that can be implemented over 1 week in the outpatient clinic.
METHODS


Participants (N = 44) were seen in the clinic daily. On Day 1, after abstaining from opioids for at least 12 h, they received buprenorphine 6-8 mg. Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine) were dispensed on Days 2-5, while ascending oral doses of naltrexone were given on Days 3-5 starting with 1 mg dose. An injection of XR-naltrexone was given on Day 5, 1 h after receiving and tolerating naltrexone 24 mg.
RESULTS


Of the 44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids. A total of 26 participants (59%) completed the induction and received their first injection of XR-naltrexone. XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.
CONCLUSION


The results support the feasibility of a week-long outpatient induction onto XR-naltrexone with ascending doses of naltrexone and standing doses of adjunctive medications. By circumventing the need for a protracted period of abstinence and mitigating the severity of withdrawal symptoms experienced during naltrexone titration, this strategy has the potential to increase patient acceptability and access to relapse prevention treatment with XR-naltrexone.",2020,XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.,"['patients with opioid use disorder', '44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids']","['release (XR) naltrexone', 'XR-naltrexone induction protocol', 'XR-naltrexone', 'buprenorphine', 'Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine', 'naltrexone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}]",[],26.0,0.0269508,XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sibai', 'Affiliation': 'Department of Psychology, University of Detroit Mercy , Detroit, MI, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Mishlen', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1700265']
888,31898804,Knee Osteonecrosis: Cell Therapy with Computer-assisted Navigation.,"BACKGROUND


The knee is the second-most common location for osteonecrosis, although it is affected much less often than the hip. Core decompression by precise drilling into ischemic lesions of the femoral condyle while remaining extra-articular is a challenge, particularly in obese patients. For cell therapy, exact localization of the injection point is important to avoid intra-articular injection.
METHODS


The precision of drilling with computer-based navigation was compared to that of conventional fluoroscopy-based drilling. A prospective, randomized study was conducted using both surgical trainees without experience and expert surgeons. First, participants performed the surgical task (core decompression) on a cadaver knee using fluoroscopic guidance or computer-based navigation. Performance was determined by the radiographic analysis of trocar placement. Next, 12 consecutive patients with bilateral symptomatic secondary (corticosteroids) osteonecrosis without collapse were included in a clinical prospective, randomized, controlled study. The 24 knees were treated using conventional fluoroscopy with expert surgeons on one side and computer-based navigation with surgical trainees on the contralateral side. Bone marrow aspirated from the two iliac crests was mixed before concentration. Each side received the same volume of concentrated bone marrow and the same number of cells (95,000 ± 25,000 cells; counted as CFU-F).
RESULTS


In the cadaver tests, the distance to the desired center-point of the lesion in the navigated group (1.6 mm) was significantly less than that in the control group (5.9 mm; p<0.001). Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries. In patients, computer navigation achieved results closer to the ideal position of the trocar, with better trocar placement in terms of tip-to-subchondral distance and ideal center position within the target for injection of stem cells. At the most recent follow-up (5 years), an increase in precision with computer-assisted navigation resulted in less collapse (4 vs. 1) and better volume of repair (11.4 vs 4.2 cm3) for knees treated with the computer-assisted technique. Failures were related to missing the target with intra-articular penetration.
CONCLUSIONS


Computer-assisted navigation improved precision with less radiation. The findings of this study suggest that computer navigation may be safely used in a basic procedure for the injection of stem cells in knee osteonecrosis.",2020,"Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries.","['surgical trainees without experience and expert surgeons', 'obese patients', '12 consecutive patients with bilateral symptomatic secondary (corticosteroids) osteonecrosis without collapse']","['computer navigation', 'conventional fluoroscopy with expert surgeons on one side and computer-based navigation with surgical trainees on the contralateral side', 'conventional fluoroscopy-based drilling', 'Computer-assisted Navigation', 'surgical task (core decompression', 'cadaver knee using fluoroscopic guidance or computer-based navigation']","['radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries', 'volume of repair', 'number of drilling corrections']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance (procedure)'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0435001', 'cui_str': 'Ligament injury (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0213412,"Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Hernigou', 'Affiliation': 'University of Paris Est, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Henri-Mondor University Hospital, Créteil, France.'}, {'ForeName': 'Jean Charles', 'Initials': 'JC', 'LastName': 'Auregan', 'Affiliation': 'Hôpital Antoine-Béclère Université Paris-Sud, Clamart, Franc.'}]",Surgical technology international,[]
889,31899035,Incidence of Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study Report 40.,"PURPOSE


To report the natural history of untreated neovascular age-related macular degeneration (nAMD) regarding subsequent macular atrophy.
DESIGN


Prospective cohort within a randomized, controlled trial of oral micronutrient supplements.
PARTICIPANTS


Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy.
METHODS


Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD). Incident macular atrophy after nAMD was examined by Kaplan-Meier analysis and proportional hazards regression.
MAIN OUTCOME MEASURES


Incident macular atrophy after nAMD.
RESULTS


Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible. The cumulative risks of incident macular atrophy after untreated nAMD were 9.6% (standard error, 1.2%), 31.4% (standard error, 2.2%), 43.1% (standard error, 2.6%), and 61.5% (standard error, 4.3%) at 2, 5, 7, and 10 years, respectively. This corresponded to a linear risk of 6.5% per year. The cumulative risk of central involvement was 30.4% (standard error, 3.2%), 43.4% (standard error, 3.8%), and 57.0% (standard error, 4.8%) at first appearance of atrophy, 2 years, and 5 years, respectively. Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006). However, higher 52-single nucleotide polymorphism AMD genetic risk score was not associated with increased risk of macular atrophy (HR, 1.03; 95% CI, 0.90-1.17; P = 0.67). Similarly, no significant differences were observed according to SNPs at CFH, ARMS2, or C3.
CONCLUSIONS


The rate of incident macular atrophy after untreated nAMD is relatively high, increasing linearly over time and affecting half of eyes by 8 years. Hence, factors other than anti-VEGF therapy are involved in atrophy development, including natural progression to GA. Comparison with studies of treated nAMD suggests it may not be necessary to invoke a large effect of anti-VEGF therapy on inciting macular atrophy, although a contribution remains possible. Central involvement is present in one third of eyes at the outset (similar to pure GA) and increases linearly to half at 3 years.",2020,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","['Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible', 'Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration', 'Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD', 'Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy']",['oral micronutrient supplements'],"['risk of macular atrophy', 'cumulative risk of central involvement', 'higher 52-single nucleotide polymorphism AMD genetic risk score', 'cumulative risks of incident macular atrophy', 'SNPs at CFH, ARMS2, or C3', 'rate of incident macular atrophy', 'Geographic atrophy (GA']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",627.0,0.0872275,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","[{'ForeName': 'Panos G', 'Initials': 'PG', 'LastName': 'Christakis', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Campbell', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'Ophthalmic Research Consultants, LLC, Waxhaw, North Carolina.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.11.016']
890,31321524,PEG vs. sennosides for opioid-induced constipation in cancer care.,"PURPOSE


This randomized double-blind, double-dummy, 2-treatment, 2-period crossover study aimed to compare the efficacy and tolerability of polyethylene glycol (PEG) and sennosides in ambulatory cancer patients with opioid-induced constipation.
METHODS


Outpatients ≥ 18 years old with cancer, at risk of or already experiencing opioid-induced constipation, were randomly assigned to begin a standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation. After 3 weeks, the patients switched to the alternate active product and dummy preparation. Constipation was assessed using the revised Victoria Bowel Performance Scale (rBPS) at the end of each of the 2 consecutive 21-day study periods for the number of days with a satisfactory bowel movement, the time in days to goal rBPS (G), and the treatment preference of each patient.
RESULTS


Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods. For the typical patient, the expected number of days with a satisfactory bowel movement per days of treatment was found to be 1.21 times higher on PEG than on sennosides in a particular period (95% credible interval 0.96 to 1.55). Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94). There was no evidence of a difference in patient preference between laxatives.
CONCLUSION


Our study found weak evidence that PEG is superior to sennosides with respect to overall effectiveness in cancer patients with opioid-induced constipation.",2020,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"['18\xa0years old with cancer, at risk of or already experiencing opioid-induced constipation', 'Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods', 'cancer patients with opioid-induced constipation', 'Outpatients ≥', 'ambulatory cancer patients with opioid-induced constipation']","['polyethylene glycol (PEG) and sennosides', 'standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation', 'PEG']","['revised Victoria Bowel Performance Scale (rBPS', 'Constipation', 'efficacy and tolerability', 'rBPS of G']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3160897'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0222045'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",70.0,0.113312,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hawley', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada. phawley@bccancer.bc.ca.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'MacKenzie', 'Affiliation': 'University of British Columbia, 317 - 2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gobbo', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04944-5']
891,31856869,The effect of educational intervention based on BASNEF model for reducing internet addiction among female students: a quasi-experimental study.,"BACKGROUND


Adolescents and students are encountered with a challenge so-called ""internet Addiction"". This issue affects both their physical and mental health, as well as their academic, social, and family performance. The aim of the current research is to determine the impact of educational intervention. To achieve this aim, BASNEF is utilized to reduce the excessive use of the internet by students.
METHODS


This quasi-experimental study was implemented on 120 high school female students in Shahrekord (west of Iran), which were addicted to the internet. Paticipants was randomly divided into two groups of control and intervention. For data collection before and after the intervention, the standard Yang internet Addiction Questionnaire and BASNEF researcher-developed Questionnaire were used. Educational intervention for mothers was conducted in one session (as the most important subjective norm) and for students in two sessions. This method was based on BASNEF construct. Then, data were analyzed using SPSS-20 and chi-square test, Mann-Whitney test, independent t-test, and paired t-test.
RESULTS


After the education intervention, the mean scores of knowledge, attitude, subjective norms, perceived behavioral control and enabling factors in the intervention group were significantly different from the control group (p < 0.001). In Post-test assessment, the intervention group revealed a significant decrease, in terms of using the internet (based on the time). (p < 0.001).
CONCLUSIONS


The results of this study revealed that BASNEF and its related constructs was a suitable framework to design the educational interventions in order to reduce the extreme use of internet in students. Applying of this model can be a cognitive and intellectual framework that affects students' internet use behavior.",2019,"After the education intervention, the mean scores of knowledge, attitude, subjective norms, perceived behavioral control and enabling factors in the intervention group were significantly different from the control group (p < 0.001).","['female students', '120 high school female students in Shahrekord (west of Iran), which were addicted to the internet', 'Adolescents and students']","['BASNEF', 'educational intervention based on BASNEF model', 'Educational intervention']","['mean scores of knowledge, attitude, subjective norms, perceived behavioral control and enabling factors']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}]",120.0,0.0183478,"After the education intervention, the mean scores of knowledge, attitude, subjective norms, perceived behavioral control and enabling factors in the intervention group were significantly different from the control group (p < 0.001).","[{'ForeName': 'Batol', 'Initials': 'B', 'LastName': 'Gholamian', 'Affiliation': 'MSc in Health Education, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Associate Professor, Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran. h_shahnazi@yahoo.com.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hassanzadeh', 'Affiliation': 'Instructor, Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Italian journal of pediatrics,['10.1186/s13052-019-0761-4']
892,31820515,The use of mentholated popsicle to reduce thirst during preoperative fasting: A randomised controlled trial.,"AIMS AND OBJECTIVES


To compare mentholated popsicle with usual care (absolute fasting) in the change of thirst intensity and discomfort of patients in the preoperative fasting.
BACKGROUND


Thirst is defined as the desire to drink water, and it is considered to be a multifactorial symptom. In the preoperative fasting, the patient may experience intense thirst, often for a long time, that can lead to feelings of suffocation, desperation, fear and anxiety.
DESIGN


A randomised controlled trial.
METHODS


Forty patients, aged between 18-60 years, were randomised to mentholated popsicle group or absolute fasting group (twenty in each). The primary outcomes were thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale), both measured twice (baseline and after 20 min of intervention). The CONSORT checklist was used to report this study.
RESULTS


Mean age was similar in both groups (38 years in the mentholated popsicle group and 39 in the absolute fasting group). At baseline, the mentholated popsicle group had higher median for the scales of intensity (6.5) and discomfort (7.5) from thirst than the absolute fasting group (5.0 and 5.0, respectively). At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively).
CONCLUSIONS


The use of mentholated popsicle decreased the intensity and discomfort from thirst, and it is a viable strategy for the management of thirst in the preoperative fasting.
RELEVANCE TO CLINICAL PRACTICE


In the preoperative fasting, making mentholated popsicles available to patients is an easy strategy to manage thirst, which might lead to better care.",2020,"At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively).
","['Forty patients, aged between 18-60\xa0years']","['mentholated popsicle', 'mentholated popsicle group or absolute fasting group']","['intensity and discomfort', 'thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale', 'scales of intensity (6.5) and discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3853215', 'cui_str': 'Popsicle'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}]",40.0,0.0638342,"At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively).
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Aroni', 'Affiliation': 'Department of Nursing, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Ligia F', 'Initials': 'LF', 'LastName': 'Fonseca', 'Affiliation': 'Department of Nursing, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Margatho', 'Affiliation': 'General and Specialized Nursing Department, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Galvão', 'Affiliation': 'General and Specialized Nursing Department, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto, Brazil.'}]",Journal of clinical nursing,['10.1111/jocn.15138']
893,31844890,A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE).,"BACKGROUND


Ofranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.
METHODS


This pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).
RESULTS


Enrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.
CONCLUSIONS


In this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.
CLINICAL TRIALS REGISTRATION


NCT02511405.",2020,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"['patients with recurrent glioblastoma (rGBM', 'patients with recurrent glioblastoma (GLOBE', '256 patients were enrolled at 57 sites']","['bevacizumab', 'VB-111 and bevacizumab versus bevacizumab monotherapy', 'VB-111 1013 viral particles q8W in combination with bevacizumab 10mg/Kg q2W (combination arm) or bevacizumab monotherapy (control arm', 'VB-111 and bevacizumab', 'VB-111 combined with bevacizumab vs. bevacizumab monotherapy']","['survival', 'rate of CNS and flu-like/fever events', 'overall survival (OS', 'objective response rate (ORR) by RANO and Progression Free Survival (PFS', 'efficacy and safety', 'ORR', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",256.0,0.111146,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Leor', 'Initials': 'L', 'LastName': 'Zach', 'Affiliation': 'Oncology Institute, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Fain Shmueli', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Patrick Y', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz232']
894,31336212,Comparison of latency and efficacy of twin mix and modified twin mix in impacted mandibular third molar surgery - A Preliminary Randomized Triple Blind Split Mouth Clinical Study.,"INTRODUCTION


Intra-space drug administration have recently gained popularity in the clinical practice posing several advantages over the conventional routes of drug administration. A preliminary prospective randomized triple blind clinical study was conducted to compare the latency and duration of anesthesia with twin mix (1.8ml 2% lignocaine with 1:200,000 epinephrine and 1ml/4mg dexamethasone) and modified twin mix (1.7ml of 4% articaine with 1:100,000 epinephrine and 1ml/4mg dexamethasone) to two conventional local anesthesia solutions along with co-relation of clinical effects in the postoperative phase in patients undergoing extraction of impacted mandibular third molars in terms of patients comfort post-surgery.
MATERIALS AND METHODS


The study was conducted among 20 patients with bilateral impacted mandibular third molars who were randomly allotted to two groups, Group A and B. Each patients in both the groups was allotted with study and control site. Among Group A, patients were further divided into Sub-group L (Control) and Sub-group TM (Twin Mix). Group B patients were divided as Sub-group A (Control) and sub-group MTM (Modified Twin Mix). Sub-group L patients received 1.8ml of 2% lignocaine with 1:200,000 adrenaline and sub-group TM received twin mix. Sub-group A received 1.7ml of 4% articaine with 1:100,000 adrenaline and sub-group MTM received modified twin mix solution. All the procedure was performed by a single operator with a gap of 1 month between the two interventions among both the groups. Various subjective and objective parameters were measured pre-operatively and postoperatively to assess the latency and efficacy of various anesthesia solutions used in this study for third molar removal.
RESULTS


Mean (±SD) VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively. The anesthetic latency was significantly less in sub-group TM, with a mean (±SD) of 52.4 (±28.3) seconds. Sub-groups A and MTM had longer latency of anesthesia when compared with L and TM sub-groups. The duration of soft tissue anesthesia was maximum in sub-group MTM as compared to the other sub-groups. Patients from control sub-groups among both the groups had increased swelling, post-surgical pain and trismus postoperatively.
DISCUSSION


Intra-space administration of twin mix and modified twin mix is clinically efficacious in impacted mandibular third molars surgery with better clinical outcomes postoperatively. We observed one significant difference between TM and MTM that the latter solution provided a prolonged duration of anesthesia increasing the patient's comfort postoperatively after surgical removal of mandibular third molars.",2020,VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively.,"['patients undergoing extraction of impacted mandibular third molars in terms of patients comfort post-surgery', '20 patients with bilateral impacted mandibular third molars']","['Sub-group A (Control) and sub-group MTM (Modified Twin Mix', 'articaine with 1:100,000 adrenaline and sub-group MTM received modified twin mix solution', 'twin mix and modified twin mix', 'anesthesia with twin mix (1.8ml 2% lignocaine with 1:200,000 epinephrine and 1ml/4mg dexamethasone) and modified twin mix (1.7ml of 4% articaine with 1:100,000 epinephrine and 1ml/4mg dexamethasone', 'lignocaine with 1:200,000 adrenaline and sub-group TM received twin mix']","['anesthetic latency', 'longer latency of anesthesia', 'VAS scores', 'swelling, post-surgical pain and trismus postoperatively', 'Mean (±SD', 'duration of soft tissue anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",,0.0542578,VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beena', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhargava', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India. Electronic address: emaildarpan@gmail.com.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gurjar', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shrivastava', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dalsingh', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Lenora Institute of Dental Sciences, 533294 Rajahmundry, AP, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Koneru', 'Affiliation': 'Sibar Institute of Dental Sciences and Research Center, Department of Oral and Maxillofacial Surgery, 522509 Vijayawada, AP, India.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.011']
895,25555505,Frontal lobe hypoactivation in medication-free adults with bipolar II depression during response inhibition.,"In executive function, specifically in response inhibition, numerous studies support the essential role for the inferior frontal cortex (IFC). Hypoactivation of the IFC during response-inhibition tasks has been found consistently in subjects with bipolar disorder during manic and euthymic states. The aim of this study was to examine whether reduced IFC activation also exists in unmedicated subjects with bipolar disorder during the depressed phase of the disorder. Participants comprised 19 medication-free bipolar II (BP II) depressed patients and 20 healthy control subjects who underwent functional magnetic resonance imaging (fMRI) while performing a Go/NoGo response-inhibition task. Whole-brain analyses were conducted to assess activation differences within and between groups. The BP II depressed group, compared with the control group, showed significantly reduced activation in right frontal regions, including the IFC (Brodmann's area (BA) 47), middle frontal gyrus (BA 10), as well as other frontal and temporal regions. IFC hypoactivation may be a persistent deficit in subjects with bipolar disorder in both acute mood states as well as euthymia, thus representing a trait feature of bipolar disorder.",2015,"The BP II depressed group, compared with the control group, showed significantly reduced activation in right frontal regions, including the IFC (Brodmann's area (BA) 47), middle frontal gyrus (BA 10), as well as other frontal and temporal regions.","['medication-free adults with bipolar II depression during response inhibition', 'unmedicated subjects with bipolar disorder during the depressed phase of the disorder', 'subjects with bipolar disorder', 'subjects with bipolar disorder during manic and euthymic states', 'Participants comprised 19 medication-free bipolar II (BP II) depressed patients and 20 healthy control subjects who underwent']",['functional magnetic resonance imaging (fMRI) while performing a Go/NoGo response-inhibition task'],"[""reduced activation in right frontal regions, including the IFC (Brodmann's area (BA) 47), middle frontal gyrus (BA 10), as well as other frontal and temporal regions"", 'IFC activation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0549224', 'cui_str': 'Frontal region'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0599720', 'cui_str': 'Brodmann area'}, {'cui': 'C0152297', 'cui_str': 'Middle frontal gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}]",,0.0320061,"The BP II depressed group, compared with the control group, showed significantly reduced activation in right frontal regions, including the IFC (Brodmann's area (BA) 47), middle frontal gyrus (BA 10), as well as other frontal and temporal regions.","[{'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Penfold', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vizueta', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Townsend', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Bookheimer', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA 90095, United States; Center for Cognitive Neuroscience, UCLA, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Lori L', 'Initials': 'LL', 'LastName': 'Altshuler', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA 90095, United States. Electronic address: laltshuler@mednet.ucla.edu.'}]",Psychiatry research,['10.1016/j.pscychresns.2014.11.005']
896,31880956,Fundamentals of randomized designs: AMEE Guide No. 128.,"This AMEE Guide summarizes fundamentals of a major experimental design option for medical education researchers: the randomised study. Medical education researchers face an overwhelming taxonomy of study design options; given the breadth of information on experimental design, the purpose of this Guide is to offer a resource for medical education researchers wishing to equip themselves with helpful information for when to match a study's objective and the use of randomised designs. Once a research question has been formulated study design is the cornerstone of the intricate, nested activities of any research project. Researchers negotiate many decisions in the pursuit of choosing an appropriate design approach; failure to do so can undermine a project's capacity to, for example, sufficiently test a hypothesis or theory. Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches. While not comprehensive, presented are key concepts alongside relevant examples from the field of health professions education.",2020,"Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches.",[],[],[],[],[],[],,0.0254372,"Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Horsley', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Custers', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Tolsgaard', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}]",Medical teacher,['10.1080/0142159X.2019.1681389']
897,31881390,Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.,"BACKGROUND


Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own.
OBJECTIVES


The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention).
METHODS


PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum.
DISCUSSION


This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
TRIAL REGISTRATION


National Clinical Trial (NCT) Identifier: NCT03925883.",2020,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","['collaboration with a large community health center whose patient population is 37% Latino', 'community health centers', 'Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy']","['targeted navigation program', 'precision health intervention', 'patient navigation or usual care']","['overall and by probability stratum', 'time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers', 'colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.111953,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA. Electronic address: Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Johnson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Schneider', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Mummadi', 'Affiliation': 'Northwest Permanente Medical Group, Portland, OR, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'Sea Mar Community Health Centers, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105920']
898,31847830,"SPAR - a randomised, placebo-controlled phase II trial of simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer: an AGITG clinical trial.","BACKGROUND


Retrospective studies show improved outcomes in colorectal cancer patients if taking statins, including overall survival, pathological response of rectal cancer to preoperative chemoradiotherapy (pCRT), and reduced acute and late toxicities of pelvic radiation. Major tumour regression following pCRT has strong prognostic significance and can be assessed in vivo using MRI-based tumour regression grading (mrTRG) or after surgery using pathological TRG (pathTRG).
METHODS


A double-blind phase 2 trial will randomise 222 patients planned to receive long-course fluoropyrimidine-based pCRT for rectal adenocarcinoma at 18+ sites in New Zealand and Australia. Patients will receive simvastatin 40 mg or placebo daily for 90 days starting 1 week prior to standard pCRT. Pelvic MRI 6 weeks after pCRT will assess mrTRG grading prior to surgery. The primary objective is rates of favourable (grades 1-2) mrTRG following pCRT with simvastatin compared to placebo, considering mrTRG in 4 ordered categories (1, 2, 3, 4-5). Secondary objectives include comparison of: rates of favourable pathTRG in resected tumours; incidence of toxicity; compliance with intended pCRT and trial medication; proportion of patients undergoing surgical resection; cancer outcomes and pathological scores for radiation colitis. Tertiary objectives include: association between mrTRG and pathTRG grouping; inter-observer agreement on mrTRG scoring and pathTRG scoring; studies of T-cell infiltrates in diagnostic biopsies and irradiated resected normal and malignant tissue; and the effect of simvastatin on markers of systemic inflammation (modified Glasgow prognostic score and the neutrophil-lymphocyte ratio). Trial recruitment commenced April 2018.
DISCUSSION


When completed this study will be able to observe meaningful differences in measurable tumour outcome parameters and/or toxicity from simvastatin. A positive result will require a larger RCT to confirm and validate the merit of statins in the preoperative management of rectal cancer. Such a finding could also lead to studies of statins in conjunction with chemoradiation in a range of other malignancies, as well as further exploration of possible mechanisms of action and interaction of statins with both radiation and chemotherapy. The translational substudies undertaken with this trial will provisionally explore some of these possible mechanisms, and the tissue and data can be made available for further investigations.
TRIAL REGISTRATION


ANZ Clinical Trials Register ACTRN12617001087347. (www.anzctr.org.au, registered 26/7/2017) Protocol Version: 1.1 (June 2017).",2019,"Major tumour regression following pCRT has strong prognostic significance and can be assessed in vivo using MRI-based tumour regression grading (mrTRG) or after surgery using pathological TRG (pathTRG).
","['colorectal cancer patients', 'for rectal adenocarcinoma at 18+ sites in New Zealand and Australia', '222 patients planned to receive', 'rectal cancer']","['simvastatin 40\u2009mg or placebo', 'long-course fluoropyrimidine-based pCRT', 'preoperative chemoradiotherapy (pCRT', 'standard chemotherapy and radiation', 'placebo', 'simvastatin']","['systemic inflammation (modified Glasgow prognostic score and the neutrophil-lymphocyte ratio', 'comparison of: rates of favourable pathTRG in resected tumours; incidence of toxicity; compliance with intended pCRT and trial medication; proportion of patients undergoing surgical resection; cancer outcomes and pathological scores for radiation colitis']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449821', 'cui_str': 'Prognostic score (attribute)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0341339', 'cui_str': 'Radiation colitis'}]",222.0,0.356171,"Major tumour regression following pCRT has strong prognostic significance and can be assessed in vivo using MRI-based tumour regression grading (mrTRG) or after surgery using pathological TRG (pathTRG).
","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Jameson', 'Affiliation': 'Waikato Hospital and Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gormly', 'Affiliation': 'Dr Jones & Partners, Eastwood, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Espinoza', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Asghari', 'Affiliation': 'Bankstown-Lidcombe Hospital, Bankstown, Australia.'}, {'ForeName': 'Grahame Mark', 'Initials': 'GM', 'LastName': 'Jeffery', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Timothy Jay', 'Initials': 'TJ', 'LastName': 'Price', 'Affiliation': 'Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christos Stelios', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Flinders Medical Centre, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arendse', 'Affiliation': 'Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Armstrong', 'Affiliation': 'Consumer Advisory Panel, Australasian Gastro-Intestinal Trials Group, Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Childs', 'Affiliation': 'Regional Cancer and Blood Centre, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Frizelle', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ngan', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stevenson', 'Affiliation': 'Royal Brisbane Hospital, Brisbane, Australia.'}, {'ForeName': 'Martinus', 'Initials': 'M', 'LastName': 'Oostendorp', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Ackland', 'Affiliation': 'University of Newcastle, Lake Macquarie Private Hospital and Calvary Mater Newcastle Hospital, Newcastle, Australia. stephen.ackland@newcastle.edu.au.'}]",BMC cancer,['10.1186/s12885-019-6405-7']
899,31833394,Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.,"Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over the past decade, the disease remains incurable; therefore, additional therapies are needed. Novel combination therapies incorporating monoclonal antibodies have shown significant promise. Here we describe the design of a Phase III study (NCT03275285, IKEMA), which is evaluating isatuximab plus carfilzomib and low-dose dexamethasone, versus carfilzomib/dexamethasone in relapsed/refractory multiple myeloma. The primary end point is progression-free survival. Responses are being determined by an independent review committee using 2016 International Myeloma Working Group criteria, and safety will be assessed throughout. The first patient was recruited in November 2017, and the last patient was recruited in March 2019; 302 patients have been randomized, and the study is ongoing. Clinical trial registration: NCT03275285.",2020,"Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over the past decade, the disease remains incurable; therefore, additional therapies are needed.","['The first patient was recruited in November 2017, and the last patient was recruited in March 2019; 302 patients', 'relapsed/refractory multiple myeloma', 'patients with relapsed/refractory multiple myeloma']","['dexamethasone, versus carfilzomib/dexamethasone', 'Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone']",['progression-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",302.0,0.0716963,"Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over the past decade, the disease remains incurable; therefore, additional therapies are needed.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': ""Department of Hematology, University Hospital, Allée de l'Ile Gloriette, Nantes, 44093, France.""}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Stadiou 5 10562 Athens, Greece.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Hematology, University College London, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mikhael', 'Affiliation': 'Department of Medicine, Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, AZ,\xa0AZ 85028, USA.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Risse', 'Affiliation': 'Sanofi, Vitry-Alfortville, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Asset', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'Department of Hematology, University of California at San Francisco, San Francisco, CA,\xa0CA 94143, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0431']
900,31333114,Comparison of the Quality of Life of Cancer Patients with Pain Treated with Oral Controlled-Release Morphine and Oxycodone and Transdermal Buprenorphine and Fentanyl.,"AIM


To compare the effects of oral morphine and oxycodone and transdermal fentanyl and buprenorphine on quality of life (QoL) of cancer patients with severe pain.
PATIENTS AND METHODS


Cancer patients with severe pain (NRS 6-10) treated at home and in outpatient clinics who failed to respond to non-opioids and/or ""weak"" opioids were randomized to morphine, oxycodone, fentanyl, or buprenorphine treatment for 28 days. Immediate-release oral morphine was rescued analgesic and 10-ml lactulose twice daily was prophylaxis of constipation; no antiemetics were used for prophylaxis.
RESULTS


Above all, 62 patients participated and 53 patients completed the study. Good analgesia was obtained with all 4 opioids. Morphine was associated with the less negative impact of pain on the ability to walk and normal work, and tendency on activity (BPI-SF) and lower consumption of rescue morphine. All 4 opioids elicited similar adverse effects. According to ESAS, the intensity of nausea and drowsiness increased at the beginning but decreased as treatment continued. Appetite, well-being, anxiety, depression, and fatigue improved. No changes were seen in constipation, vomiting and dyspnea. Constipation was rarely observed with all opioids (BFI). Any opioids improved overall QoL and emotional functioning with tendency improving physical functioning (EORTC QLQ-C15-PAL). Activity improved (Karnofsky). Morphine induced greater improvement in physical functioning and trend in improvement mood (HADS).
CONCLUSION


All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.",2019,All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.,"['cancer patients with severe pain', 'cancer patients with pain treated with oral controlled-release', '62 patients participated and 53 patients completed the study', 'Cancer patients with severe pain (NRS 6-10) treated at home and in outpatient clinics who failed to respond to non-opioids and/or ""weak"" opioids']","['morphine and oxycodone and transdermal fentanyl and buprenorphine', 'morphine and oxycodone and transdermal buprenorphine and fentanyl', 'morphine', 'morphine, oxycodone, fentanyl, or buprenorphine', 'Morphine']","['Constipation', 'nausea and drowsiness', 'overall QoL and emotional functioning', 'physical functioning', 'quality of life (QoL', 'Good analgesia', 'negative impact of pain on ability to walk and normal work, and tendency on activity (BPI-SF) and lower consumption of rescue morphine', 'Appetite, well-being, anxiety, depression, and fatigue improved', 'Activity improved (Karnofsky', 'improvement mood (HADS', 'adverse effects', 'constipation, vomiting and dyspnea']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",62.0,0.034576,All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.,"[{'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Leppert', 'Affiliation': 'Laboratory of Quality of Life Research, Chair and Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Nosek', 'Affiliation': 'Non-public Saint Lazarius Health Care Unit, Biskupiec, Poland.'}]",Current pharmaceutical design,['10.2174/1381612825666190717091230']
901,31319427,Effects of Pre- and Post-Exercise Cold-Water Immersion Therapy on Passive Muscle Stiffness.,"BACKGROUND


Cold-water immersion (CWI) has become a popular preventive, regenerative and performance-enhancing intervention in various sports. However, its effects on soft tissue, including changes of intramuscular stiffness, are poorly understood. The purpose of this study was to investigate the effect of CWI on muscle stiffness.
PATIENTS/MATERIAL AND METHODS


Thirty healthy participants were included and divided into the three following groups (n = 10): 1) post-ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up). Acoustic radiation force impulse (ARFI) elastography was conducted to assess tissue stiffness (shear wave velocity, SWV). Values obtained at resting conditions (baseline, t0) were compared to values post-exercise (t1, for post-ESU group and control group), post-CWI (t2, for post-ESU group and pre-ESU group; rest for control group) and to 60-min follow-up time (t3, for all groups). Data were assessed in superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI).
RESULTS


For the post-ESU group (CWI post-exercise), there was no significant difference between the time points of measurements: exercise (t1: RF: 1.63 m/s; VI: 1.54 m/s), CWI (t2: RF: 1.63 m/s; VI: 1.53 m/s) and at 60-min follow-up (t3: RF: 1.72 m/s; VI: 1.61 m/s). In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084). For t2 and t3, no further significant changes were detected. Regarding the pre-exercise set-up (pre-ESU group), a significant decrease in SWV from baseline to t2 in VI (1.60 m/s to 1.49 m/s; VI: p = 0.027) was found.
CONCLUSION


This study shows varying influences of CWI on muscle stiffness. Overall, we did not detect any significant effects of CWI on muscle stiffness post-exercise. Muscle stiffness-related effects of CWI differ in the context of a pre- or post-exercise condition and have to be considered in the implementation of CWI to ensure its potential preventive and regenerative benefits.",2019,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).",['Thirty healthy participants'],"['Cold-water immersion (CWI', 'Acoustic radiation force impulse (ARFI) elastography', 'CWI', 'ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up', 'Pre- and Post-Exercise Cold-Water Immersion Therapy']","['tissue stiffness (shear wave velocity, SWV', 'Passive Muscle Stiffness', 'superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI', 'SWV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0224448', 'cui_str': 'Vastus Intermedius'}]",30.0,0.060789,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hüttel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Golditz', 'Affiliation': 'Department of Orthopedic Trauma Surgery, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg Germany, Erlangen, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Heiss', 'Affiliation': 'Department of Radiology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lutter', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, Germany.'}, {'ForeName': 'Matthias Wilhelm', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Seehaus', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Forst', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}]",Sportverletzung Sportschaden : Organ der Gesellschaft fur Orthopadisch-Traumatologische Sportmedizin,['10.1055/a-0854-8302']
902,31831028,The clinical outcome of Dienogest treatment followed by in vitro fertilization and embryo transfer in infertile women with endometriosis.,"BACKGROUND


Endometriosis is considered to be the most intractable cause of female infertility. Administering any type of treatment for endometriosis before in vitro fertilization and embryo transfer (IVF-ET) is an important strategy for improving the IVF-ET outcomes for infertile women with endometriosis. In fact, treatment with a gonadotropin-releasing hormone (GnRH) agonist just before IVF-ET has been reported to improve the clinical outcome in endometriosis patients. However, the benefit of Dienogest (DNG), a synthetic progestin, treatment just before IVF-ET remains unclear.
METHODS


Sixty-eight infertile women with Stage III or IV endometriosis (ovarian endometrial cyst < 4 cm) were recruited for this study. The subjects were divided into 2 groups: a DNG group (n = 33) and a control group (n = 35). DNG was administered orally every day for 12 weeks prior to the conventional IVF-ET cycle in the DNG group. Standard controlled ovarian hyperstimulation with the GnRH agonist long protocol was performed in the control group. The numbers of mature follicles and retrieved oocytes, fertilization rates, implantation rates, and clinical pregnancy rate were compared between the two groups. In addition, the concentrations of inflammatory cytokines, oxidative stress markers, and antioxidants in follicular fluids were also measured.
RESULTS


The numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts were significantly lower in the DNG group than in the control group. The fertilization and blastocyst rates were also lower in the DNG group than in the control group. Although there was no significant difference in the implantation rate between the groups, the cumulative pregnancy rate and live birth rate were lower in the DNG group than in the control group. There was no significant difference in the abortion rate. Our results failed to show that DNG reduces the inflammatory cytokine levels and oxidative stress in follicular fluids.
CONCLUSIONS


Administering DNG treatment just before IVF-ET did not provide any benefits to improve the clinical outcomes for infertile women with endometriosis.",2019,"The numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts were significantly lower in the DNG group than in the control group.","['infertile women with endometriosis', 'endometriosis patients', 'Sixty-eight infertile women with Stage III or IV endometriosis (ovarian endometrial cyst <\u20094\u2009cm']","['embryo transfer (IVF-ET', 'DNG', 'Dienogest treatment followed by in vitro fertilization and embryo transfer', 'gonadotropin-releasing hormone (GnRH) agonist just before IVF-ET']","['abortion rate', 'concentrations of inflammatory cytokines, oxidative stress markers, and antioxidants in follicular fluids', 'numbers of mature follicles and retrieved oocytes, fertilization rates, implantation rates, and clinical pregnancy rate', 'cumulative pregnancy rate and live birth rate', 'numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts', 'fertilization and blastocyst rates', 'inflammatory cytokine levels and oxidative stress', 'implantation rate']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0585788,"The numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts were significantly lower in the DNG group than in the control group.","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamura', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan. hitamura@yamaguchi-u.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Center for Reproductive Medicine, Sendai ART Clinic, Nakakecho 206-13, Miyagino-ku, Sendai, 983-0864, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kikuchi', 'Affiliation': 'Center for Reproductive Medicine, Sendai ART Clinic, Nakakecho 206-13, Miyagino-ku, Sendai, 983-0864, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Josaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Mihara', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Yuichro', 'Initials': 'Y', 'LastName': 'Shirafuta', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinagawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Tamura', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Taketani', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Takasaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Saiseikai Shimonoseki General Hospital, Yasuokacho 8-5-1, Shimonoseki, 759-6603, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Sugino', 'Affiliation': 'Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine, Minamikogushi 1-1-1, Ube, 755-8505, Japan.'}]",Journal of ovarian research,['10.1186/s13048-019-0597-y']
903,31856001,"Impact of a Progressive Mobility Program on the Functional Status, Respiratory and Muscular Systems of ICU Patients: A Randomized and Controlled Trial.","OBJECTIVES


The aim was to investigate whether patients who participated in a mobility program in the ICU performed better on functional status, muscle, mobility, and respiratory assessments upon discharge than patients who received conventional physiotherapy.
DESIGN


Randomized controlled trial.
SETTING


Blind evaluation.
PATIENTS


Adults with previous functional independence and without contraindications for mobilization were eligible.
INTERVENTIONS


The intervention group participated in an early and progressive mobility program with five levels of activity. The control group underwent the conventional treatment without a preestablished routine. We evaluated functional status, level of activity, respiratory status, muscle strength, and mobility at ICU discharge.
MEASUREMENTS AND MAIN RESULTS


We analyzed 49 patients in the control group and 50 patients in the intervention group. Our data showed patients with better functional status and more functionally independent patients in the intervention group compared with those in the control group (96% vs 44%; p < 0.001). The results of the sit-to-stand and 2-minute walk tests, as well as the results of the maximum voluntary ventilation tests, also varied between the groups. The intervention group had shorter ICU stays than the control group. Higher Barthel index scores were associated with the amount of activity and participation in the protocol. The benefits to functional status remained during follow-up.
CONCLUSIONS


Patients who participated in an ICU mobility program had better functional status at discharge from the ICU. The other benefits of the program included better performance in the mobility tests and improved maximum voluntary ventilation performance.",2019,The intervention group had shorter ICU stays than the control group.,"['ICU Patients', 'patients who participated in a mobility program in the ICU performed better on', 'Adults with previous functional independence and without contraindications for mobilization were eligible']","['Progressive Mobility Program', 'conventional treatment without a preestablished routine', 'conventional physiotherapy']","['Higher Barthel index scores', 'shorter ICU stays', 'Functional Status, Respiratory and Muscular Systems', 'functional status, muscle, mobility, and respiratory assessments upon discharge', 'functional status, level of activity, respiratory status, muscle strength, and mobility at ICU discharge', 'maximum voluntary ventilation performance', 'functional status']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C3650998', 'cui_str': 'Advancing mobility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0549075', 'cui_str': 'Respiratory assessment (procedure)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}]",,0.0389325,The intervention group had shorter ICU stays than the control group.,"[{'ForeName': 'Debora Stripari', 'Initials': 'DS', 'LastName': 'Schujmann', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tamires', 'Initials': 'T', 'LastName': 'Teixeira Gomes', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana Claudia', 'Initials': 'AC', 'LastName': 'Lunardi', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Zoccoler Lamano', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Aretha', 'Initials': 'A', 'LastName': 'Fragoso', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mayara', 'Initials': 'M', 'LastName': 'Pimentel', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Neri', 'Initials': 'CN', 'LastName': 'Peso', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Araujo', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, Hospital das Clinicas of University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Critical care medicine,['10.1097/CCM.0000000000004181']
904,31334882,"Impact of web-based learning for health program planning competency, knowledge and skills among mid-level public health nurses: A randomized controlled trial.","OBJECTIVES


To evaluate the impact of web-based learning modules for health program planning competency, recognition, knowledge and skills among mid-level public health nurses (PHNs).
DESIGN


Parallel-group randomized controlled trial.
SAMPLE


During 2018, 244 Japanese PHNs were eligible as participants with 5-20 years experiences as a PHN were randomly allocated to the intervention (n = 121) or control group (n = 123).
MEASUREMENTS


The outcome was assessed using the Competency Measurement of Creativity for PHNs (CMC) and 26 questions about recognition, knowledge, and skills for health program planning.
INTERVENTIONS


Eight web-based modules.
RESULTS


No significant differences in CMC scores between the control and intervention groups at base line and post-intervention. By contrast, significant differences in total score of the 26 items of knowledge and skills. In an exploratory analysis, there was a significant difference identified in CMC scores in the demographic of post graduate training in program planning at base line and post-intervention. (p = .034).
CONCLUSIONS


The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.",2019,"The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.","['mid-level public health nurses (PHNs', 'mid-level public health nurses', 'During 2018, 244 Japanese PHNs were eligible as participants with 5-20\xa0years experiences as a PHN']",[],"['CMC scores', 'total score', 'Competency Measurement of Creativity for PHNs (CMC) and 26 questions about recognition, knowledge, and skills for health program planning']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034022', 'cui_str': 'Public Health Nurses'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0010297', 'cui_str': 'Creative Thinking'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",244.0,0.0519518,"The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.","[{'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Yoshioka-Maeda', 'Affiliation': 'Department of Health Promotion, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Shiomi', 'Affiliation': 'Department of Community Health Nursing, School of Nursing, College of Nursing Art and Science, University of Hyogo, Hyogo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Department of Statistic and Computer Science, College of Nursing Art and Science, University of Hyogo, Hyogo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Hosoya', 'Affiliation': 'Department of Community Health Nursing, School of Nursing, Chiba Prefectural University of Health Sciences, Chiba, Japan.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12642']
905,31335755,Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial.,"BACKGROUND


Periintubation hypotension is associated with poor outcomes in the critically ill. We aimed to determine if an admixture of ketamine and propofol for emergent endotracheal intubation in critically ill patients was superior to etomidate. Primary endpoint was the change in mean arterial pressure from baseline to 5 minutes postdrug administration.
METHODS


Emergent-use, stratified (shock status and unit type), multiunit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center. Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation were assigned randomly to receive either ketamine/propofol admixture (0.5 mg/kg of ketamine and propofol each) or reduced dose etomidate (0.15 mg/kg) for emergent intubation.
RESULTS


One hundred sixty participants were randomized, and 152 (79 ketamine/propofol admixture, 73 etomidate) were included in the intention-to-treat analysis. There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes postdrug administration (treatment difference [ketamine/propofol admixture-etomidate]: -2.1 mm Hg; 95% confidence interval, -6.9 mm Hg to +2.7 mm Hg; p = 0.385). In addition, no statistically significant difference was demonstrated in the change of mean arterial pressure from baseline at 10 minutes and 15 minutes postdrug administration, no statistical difference in the use of new-onset vasoactive agents or difficulty of intubation between groups. More patients in the etomidate group required non-red blood cell transfusions (16 [22%] vs. 8 [10%], p = 0.046). For patients who had adrenal testing performed, more patients in the etomidate group developed immediate adrenal insufficiency (13 [81%] of 16 vs. 5 [38%] of 13, p = 0.027). Serious adverse events were rare, 2 (3%) (cardiac arrest, hypotension) in ketamine/propofol admixture and 4 (5%) (hypertension, hypotension) in etomidate (p = 0.430).
CONCLUSION


In a heterogeneous critically ill population, ketamine/propofol admixture was not superior to a reduced dose of etomidate at preserving per-intubation hemodynamics and appears to be a safe alternative induction agent in the critically ill.
LEVEL OF EVIDENCE


Therapeutic/Care Management, level II.
TRIAL REGISTRY


ClinicalTrials.gov, NCT02105415, Ketamine/Propofol Admixture ""Ketofol"" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial, IRB 13-000506, Trial Registration: March 31, 2014.",2019,There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes post-drug administration [treatment difference (ketamine/propofol admixture - etomidate):,"['critically-ill patients', 'Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation', 'Emergent-use, stratified (shock status and unit type), multi-unit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center', 'One hundred and sixty participants were randomized and 152 (79']","['ketamine/propofol admixture, 73 etomidate', 'ketamine/propofol admixture [0.5 mg/kg of ketamine and propofol each] or reduced dose etomidate [0.15 mg/kg] for emergent intubation', 'KEtaminE/ProPofol Admixture vs Etomidate', 'etomidate', 'ketamine and propofol', 'ketamine/propofol admixture']","['mean arterial pressure change', 'immediate adrenal insufficiency', 'hypertension, hypotension', 'non-red blood cell transfusions', 'Serious adverse events', 'cardiac arrest, hypotension', 'mean arterial pressure']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0565912', 'cui_str': 'Unit type (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0001623', 'cui_str': 'Adrenal Insufficiency'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",160.0,0.3358,There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes post-drug administration [treatment difference (ketamine/propofol admixture - etomidate):,"[{'ForeName': 'Nathan Jerome', 'Initials': 'NJ', 'LastName': 'Smischney', 'Affiliation': 'From the Department of Anesthesiology and Perioperative Medicine (N.J.S., W.T.N., D.R.B., B.P.), Division of Pulmonary and Critical Care Medicine (A.G.D.M., S.S.H., R.A.O., V.N.I., O.G., P.R.B.), Department of Biostatistics (D.R.S.), and Hemodynamic and Airway Management Group (HEMAIR) (N.J.S., D.R.B., O.G.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Wayne T', 'Initials': 'WT', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gallo De Moraes', 'Affiliation': ''}, {'ForeName': 'Sumedh S', 'Initials': 'SS', 'LastName': 'Hoskote', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pickering', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Oeckler', 'Affiliation': ''}, {'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Iyer', 'Affiliation': ''}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': ''}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Bauer', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002448']
906,31882644,The Impact of MRI Features and Observer Confidence on the Treatment Decision-Making for Patients with Untreated Glioma.,"In a blind, dual-center, multi-observer setting, we here identify the pre-treatment radiologic features by Magnetic Resonance Imaging (MRI) associated with subsequent treatment options in patients with glioma. Study included 220 previously untreated adult patients from two institutions (94 + 126 patients) with a histopathologically confirmed diagnosis of glioma after surgery. Using a blind, cross-institutional and randomized setup, four expert neuroradiologists recorded radiologic features, suggested glioma grade and corresponding confidence. The radiologic features were scored using the Visually AcceSAble Rembrandt Images (VASARI) standard. Results were retrospectively compared to patient treatment outcomes. Our findings show that patients receiving a biopsy or a subtotal resection were more likely to have a tumor with pathological MRI-signal (by T2-weighted Fluid-Attenuated Inversion Recovery) crossing the midline (Hazard Ratio; HR = 1.30 [1.21-1.87], P < 0.001), and those receiving a biopsy sampling more often had multifocal lesions (HR = 1.30 [1.16-1.64], P < 0.001). For low-grade gliomas (N = 50), low observer confidence in the radiographic readings was associated with less chance of a total resection (P = 0.002) and correlated with the use of a more comprehensive adjuvant treatment protocol (Spearman = 0.48, P < 0.001). This study may serve as a guide to the treating physician by identifying the key radiologic determinants most likely to influence the treatment decision-making process.",2019,"For low-grade gliomas (N = 50), low observer confidence in the radiographic readings was associated with less chance of a total resection (P = 0.002) and correlated with the use of a more comprehensive adjuvant treatment protocol (Spearman = 0.48, P < 0.001).","['patients with glioma', '220 previously untreated adult patients from two institutions (94\u2009+\u2009126 patients) with a histopathologically confirmed diagnosis of glioma after surgery', 'Patients with Untreated Glioma']",['Magnetic Resonance Imaging (MRI'],"['chance of a total resection', 'MRI Features and Observer Confidence', 'pathological MRI-signal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}]",220.0,0.0436699,"For low-grade gliomas (N = 50), low observer confidence in the radiographic readings was associated with less chance of a total resection (P = 0.002) and correlated with the use of a more comprehensive adjuvant treatment protocol (Spearman = 0.48, P < 0.001).","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Due-Tønnessen', 'Affiliation': 'Department of Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway. pdue@ous-hf.no.'}, {'ForeName': 'Marco C', 'Initials': 'MC', 'LastName': 'Pinho', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kyrre E', 'Initials': 'KE', 'LastName': 'Emblem', 'Affiliation': 'Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Hald', 'Affiliation': 'Department of Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kanoto', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Medicine, Yamagata University, Yamagata, Japan.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Abildgaard', 'Affiliation': 'Department of Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Donatas', 'Initials': 'D', 'LastName': 'Sederevicius', 'Affiliation': 'Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Inge R', 'Initials': 'IR', 'LastName': 'Groote', 'Affiliation': 'Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Rapalino', 'Affiliation': 'Department of Radiology and Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}]",Scientific reports,['10.1038/s41598-019-56333-x']
907,31875047,Habitual physical activity mediates the acute exercise-induced modulation of anxiety-related amygdala functional connectivity.,"Aerobic exercise, in relation to physical activity, has been shown to have beneficial effects on anxiety. However, the underlyig neural mechanism remains elusive. Using a within-subject crossover design, this fMRI study examined how exercise (12-min treadmill running versus walking) mediated amygdala reactivity to explicit and implicit (backward masked) perception of emotional faces in young adults (N = 40). Results showed that acute exercise-induced differences of state anxiety (STAI-S) varied as a function of individual's habitual physical activity (IPAQ). Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05). Path analyses indicated that IPAQ explained 14.67% of the variance in acute exercise-induced STAI-S differences. Running elicited stronger amygdala reactivity to implicit happiness than fear, whereas walking did the opposite. The exercise-induced amygdala reactivity to explicit fear was associated with the IPAQ scores and STAI-S differences. Moreover, after running, the amygdala exhibited a positive functional connectivity with the orbitofrontal cortex and insula to implicit happiness, but a negative connectivity with the parahippocampus and subgenual cingulate to implicit fear. The findings suggest that habitual physical activity could mediate acute exercise-induced anxiolytic effects in regards to amygdala reactivity, and help establish exercise training as a form of anxiolytic therapy towards clinical applications.",2019,Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05).,['young adults (N\u2009=\u200940'],"['Aerobic exercise', 'exercise (12-min treadmill running versus walking) mediated amygdala reactivity to explicit and implicit (backward masked) perception of emotional faces']","['STAI-S reduction', 'IPAQ scores and STAI-S differences', ""function of individual's habitual physical activity (IPAQ"", 'state anxiety (STAI-S']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.016382,Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05).,"[{'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Yang-Ming University Hospital, Yilan, Taiwan.'}, {'ForeName': 'Chenyi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Róger Marcelo', 'Initials': 'RM', 'LastName': 'Martínez', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, USA.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Yang-Ming University Hospital, Yilan, Taiwan. ywcheng2@ym.edu.tw.'}]",Scientific reports,['10.1038/s41598-019-56226-z']
908,30593884,Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care.,"Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Eligible and consenting patients will then complete the DST assessment and are randomised and stratified according to predicted symptom severity. Participants allocated to the intervention arm will receive feedback on DST responses, select treatment priorities, assess motivation to change, and receive a severity-matched treatment recommendation (information about and links to low intensity services for those with mild symptoms, or assistance from a specially trained health professional (care navigator) for those with severe symptoms). All patients allocated to the comparison arm will receive usual GP care plus attention control. Primary (psychological distress) and secondary (depression, anxiety, quality of life, days out of role) outcomes will be assessed at 6 and 12 months. Differences in outcome means between trial arms both across and within symptom severity group will be examined using intention-to-treat analyses. Within trial and modelled economic evaluations will be conducted to determine the value for money of credentials of Link-me. Findings will be reported to the Federal Government to inform how mental health services across Australia are funded and delivered in the future.",2019,"Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs.","['stepped mental health care in primary care', ""general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room""]","['intervention arm will receive feedback on DST responses, select treatment priorities, assess motivation to change, and receive a severity-matched treatment recommendation (information about and links to low intensity services for those with mild symptoms, or assistance from a specially trained health professional (care navigator', 'usual GP care plus attention control']","['Primary (psychological distress) and secondary (depression, anxiety, quality of life, days out of role']","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.108692,"Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, University of Melbourne. Electronic address: susanlf@unimelb.edu.au.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, University of Melbourne.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, University of Melbourne.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Chatterton', 'Affiliation': 'School of Health and Social Development, Deakin University.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Spittal', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'School of Health and Social Development, Deakin University.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, University of Melbourne.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'School of Public Health, The University of Queensland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Burgess', 'Affiliation': 'School of Public Health, The University of Queensland.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Bassilios', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pirkis', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, University of Melbourne.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.12.014']
909,31823822,Zoledronic acid ameliorates the effects of secondary osteoporosis in rheumatoid arthritis patients.,"BACKGROUND


Secondary osteoporosis may occur in patients with rheumatoid arthritis (RA), causing irreversible joint damage and disability. Bisphosphonates, the recently developed bone resorption inhibitors, have demonstrated significant therapeutic effects on senile and postmenopausal osteoporosis. This study evaluated the efficacy and safety of zoledronic acid (ZOL), with or without methotrexate (MTX), for the prevention and treatment of bone destruction in RA patients.
METHODS


We recruited 66 RA patients with symptoms of secondary osteoporosis. They were randomized into three treatment groups-combined treatment with MTX and ZOL, ZOL monotherapy, or MTX monotherapy-in two consecutive 6-month periods. The participants were followed for 12 months. At the end of each treatment period, improvement in disease activity, bone destruction, and fracture risk were evaluated.
RESULTS


Combined treatment with ZOL and MTX had significantly better clinical efficacy compared with either ZOL or MTX monotherapy (P < 0.05). The combination significantly improved the lumbar spine and hip BMD and reduced FRAX scores, suggesting that ZOL combined with MTX reduces bone loss and risk of hip fracture in RA patients with secondary osteoporosis.
CONCLUSION


ZOL has a synergistic effect when combined with MTX, inhibiting RA disease activity, reducing fracture risk, and improving quality of life in RA patients with secondary osteoporosis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800019290. Registered 3 November 2018-Retrospective registered, http://www.chictr.org.cn/showproj.aspx?proj = 31758.",2019,"RESULTS


Combined treatment with ZOL and MTX had significantly better clinical efficacy compared with either ZOL or MTX monotherapy (P < 0.05).","['rheumatoid arthritis patients', '66 RA patients with symptoms of secondary osteoporosis', 'RA patients', 'patients with rheumatoid arthritis (RA', 'RA patients with secondary osteoporosis']","['ZOL and MTX', 'ZOL combined with MTX', 'Bisphosphonates', 'zoledronic acid (ZOL), with or without methotrexate (MTX', 'MTX and ZOL, ZOL monotherapy, or MTX monotherapy', 'ZOL', 'ZOL or MTX monotherapy', 'Zoledronic acid']","['lumbar spine and hip BMD and reduced FRAX scores', 'clinical efficacy', 'disease activity, bone destruction, and fracture risk', 'bone loss and risk of hip fracture', 'quality of life']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3839589', 'cui_str': 'Secondary osteoporosis'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure (procedure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0034380'}]",,0.0328983,"RESULTS


Combined treatment with ZOL and MTX had significantly better clinical efficacy compared with either ZOL or MTX monotherapy (P < 0.05).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, The Tenth People's Hospital Affiliated to Nanjing Medical University, No. 301 Yanchangzhong Road, Shanghai, 200000, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, The Tenth People's Hospital Affiliated to Nanjing Medical University, No. 301 Yanchangzhong Road, Shanghai, 200000, China. doctorli77@163.com.""}, {'ForeName': 'Lianbo', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China. 13701888178@163.com.'}, {'ForeName': 'Guilin', 'Initials': 'G', 'LastName': 'Ouyang', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China.'}, {'ForeName': 'Yubiao', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China.'}, {'ForeName': 'Chengxin', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China.'}, {'ForeName': 'Xiuwei', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Joint Orthopedics, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 504 Xinhua Road, Shanghai, 200052, China.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1492-3']
910,31335267,Beyond Personal Responsibility: Examining the Effects of Narrative Engagement on Communicative and Civic Actions.,"Moving beyond personal responsibility-taking behaviors, this paper examines  communicative  (interpersonal talk and online message sharing) and  civic  (public policy support and intention to donate) behavioral outcomes in the context of narrative persuasion. A web-based experiment was conducted to test the mediating effects of two narrative engagement constructs, transportation and empathy, on these behavioral outcomes. Participants recruited via Amazon Mechanical Turk (n = 467) participated in an experiment conducted on Qualtrics, where they were randomized to read either a narrative or a nonnarrative message about factors contributing to obesity. The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes. Path analyses showed consistent, significant indirect effects via transportation and affective empathy on all the outcome variables: online message sharing, interpersonal talk, public policy support, and intention to donate to a non-profit obesity organization. Our study contributes to the extant narrative research by shedding light on how narrative messages, via engaging the audience, could shape social responses beyond personal responsibility-taking. Implications and limitations of findings were discussed.",2019,"The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes.",['Participants recruited via Amazon Mechanical Turk (n\xa0=\xa0467) participated in an experiment conducted on Qualtrics'],['Narrative Engagement'],"['message sharing, interpersonal talk, public policy support, and intention to donate to a non-profit obesity organization']","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0034033', 'cui_str': 'Public Policy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0220885', 'cui_str': 'organization'}]",467.0,0.0211891,"The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Qian', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1643954']
911,31889152,"Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial.","Recently non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT). However, the role of NOAC after thrombolysis of acute iliofeomral DVT (IFDVT) is not yet defined. This randomized clinical trial aimed to compare the safety and efficacy of rivaroxaban versus warfarin after catheter directed thrombolysis of an IFDVT. Patients with acute DVT of both the iliac and the femoral vein (n = 72) were recruited and randomized to either standard anticoagulation (enoxaparin and warfarin, n = 35) or rivaroxaban (n = 37) after successful thrombolysis or mechanical thrombectomy. Primary efficacy outcome was a recurrence of any venous thromboembolism (VTE) within 6 months. Secondary safety outcomes included major bleeding, clinically relevant non-major bleeding (CRNMB), other adverse event, and all-cause mortality. Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94). Major bleeding or CRNMB was less in rivaroxaban group without significance (2.9% versus 9.4%, HR, 0.31; 95% CI, 0.03-2.96; p = 0.31). Recurrence-free survival and major bleeding-free survival at 6 months were not different in both groups. After thrombolysis of acute IFDVT, rivaroxaban was as safe and effective as warfarin in preventing DVT recurrence.",2019,Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94).,"['Iliofemoral Venous Thrombosis', 'Patients with acute DVT of both the iliac and the femoral vein (n\u2009=\u200972', 'Acute']","['standard anticoagulation (enoxaparin and warfarin, n\u2009=\u200935) or rivaroxaban', 'successful thrombolysis or mechanical thrombectomy', 'Rivaroxaban', 'rivaroxaban', 'warfarin', 'Vitamin K antagonist oral anticoagulants (NOAC']","['DVT recurrence', 'Rate of recurrent VTE', 'Major bleeding or CRNMB', 'recurrence of any venous thromboembolism (VTE', 'major bleeding, clinically relevant non-major bleeding (CRNMB), other adverse event, and all-cause mortality', 'safety and efficacy', 'Recurrence-free survival and major bleeding-free survival']","[{'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0642228', 'cui_str': 'NOAC'}]","[{'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.167224,Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94).,"[{'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Kang', 'Affiliation': 'Departments of Surgery, Gachon University Gil Medical center, Incheon, South Korea.'}, {'ForeName': 'Ki-Hyuk', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Sanghyun', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sungsin', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ahram', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Taeseung', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Bundang Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'In Mok', 'Initials': 'IM', 'LastName': 'Jung', 'Affiliation': 'Seoul Metropolitan Government Seoul National University Boramae Hospital, Seoul, South Korea.'}, {'ForeName': 'Jang Yong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Seung-Kee', 'Initials': 'SK', 'LastName': 'Min', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea. skminmd@snuh.org.'}]",Scientific reports,['10.1038/s41598-019-56887-w']
912,31094774,"Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.","BACKGROUND


Postoperative nausea and vomiting (PONV) occurs commonly in surgical patients despite widespread prophylactic antiemetic use. Rescue options are currently limited. 5HT3 antagonists are most frequently used for prophylaxis, but if they fail, additional doses are not effective as rescue medication. Intravenous (IV) amisulpride, a well-studied D2/D3 antagonist, has been shown in trials to prevent PONV. This study was designed to determine if amisulpride could be used to treat established PONV in patients at low-to-moderate risk of PONV who had not received any prior prophylaxis.
METHODS


Men and women aged over 18 years were permitted to enroll if they were to undergo general inhalational anesthesia, expected to last at least 1 hour, for an outpatient or inpatient surgical procedure. Patients who then suffered PONV were randomized equally to 1 of 3 single-dose IV regimens: placebo or 5 or 10 mg amisulpride. The primary end point was complete response, defined as no emesis in the period 30 minutes to 24 hours after study drug treatment and no use of rescue medication in the entire 24-hour period.
RESULTS


One thousand nine hundred eighty-eight patients were enrolled preoperatively, of whom 560 were randomized to a treatment arm. Complete response occurred in 39 of 181 patients (21.5%) in the placebo group compared to 60 of 191 patients (31.4%; P = .016) and 59 of 188 patients (31.4%; P = .016) in the amisulpride 5 and 10 mg groups, respectively. The adverse event profile of amisulpride at either dose was similar to placebo.
CONCLUSIONS


IV amisulpride at 5 and 10 mg was safe and efficacious in the treatment of established PONV in surgical patients undergoing general anesthesia with no prior PONV prophylaxis.",2019,"Complete response occurred in 39 of 181 patients (21.5%) in the placebo group compared to 60 of 191 patients (31.4%; P = .016) and 59 of 188 patients (31.4%; P = .016) in the amisulpride 5 and 10 mg groups, respectively.","['Patients who then suffered PONV', 'Men and women aged over 18 years', 'Patients', 'surgical patients despite widespread prophylactic antiemetic use', 'One thousand nine hundred eighty-eight patients were enrolled preoperatively, of whom 560', 'patients at low-to-moderate risk of PONV who had not received any prior prophylaxis', 'surgical patients undergoing general anesthesia with no prior PONV prophylaxis']","['amisulpride', 'placebo', 'Placebo', 'Intravenous (IV) amisulpride', 'placebo or 5 or 10 mg amisulpride', 'Amisulpride']","['Established Postoperative Nausea and Vomiting', 'complete response, defined as no emesis', 'Complete response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205391', 'cui_str': 'Widespread (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",1988.0,0.403114,"Complete response occurred in 39 of 181 patients (21.5%) in the placebo group compared to 60 of 191 patients (31.4%; P = .016) and 59 of 188 patients (31.4%; P = .016) in the amisulpride 5 and 10 mg groups, respectively.","[{'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Candiotti', 'Affiliation': 'From the Department of Anesthesiology, Jackson Memorial Hospital, Miami, Florida.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anaesthesia and Critical Care, University Hospitals of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Bergese', 'Affiliation': 'Department of Anesthesiology, Wexner Medical Center at The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Melson', 'Affiliation': 'Department of Anesthesia, Helen Keller Hospital, Sheffield, Alabama.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anesthesiology, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Anesthesia, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Yiliam', 'Initials': 'Y', 'LastName': 'Rodriguez', 'Affiliation': 'From the Department of Anesthesiology, Jackson Memorial Hospital, Miami, Florida.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Minkowitz', 'Affiliation': 'Department of Anesthesia, Memorial Hermann Hospital, Houston, Texas.'}, {'ForeName': 'Sabry S', 'Initials': 'SS', 'LastName': 'Ayad', 'Affiliation': 'Anesthesiology Institute, Outcomes Research, Fairview Hospital, Cleveland Clinic Health System, Cleveland, Ohio.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Diemunsch', 'Affiliation': ""Service d'Anesthésie-Réanimation Chirurgicale, Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Fox', 'Affiliation': 'Department of Clinical Development, Acacia Pharma, Cambridge, United Kingdom.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003733']
913,30963440,Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.,"BACKGROUND


African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.
RESEARCH DESIGN AND METHODS


This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.
RESULTS


At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.
CONCLUSIONS


The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
NIH TRIAL REGISTRY NUMBER


NCT01901952.",2019,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
","['Urban Low-Income African Americans with Type 2 Diabetes', 'African Americans', 'African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME', 'low-income African-American patients of public hospital clinics']","['Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes', 'Lifestyle Intervention', 'LIFE intervention', 'DSME intervention']","['diet quality', 'medication adherence', 'nutrition knowledge', 'nutrition knowledge and diet quality', 'changes in hemoglobin A1c (A1c']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.0685125,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Lynch', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA. Elizabeth_lynch@rush.edu.'}, {'ForeName': 'Laurin', 'Initials': 'L', 'LastName': 'Mack', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dawar', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'DeJuran', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Appelhans', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Tahsin', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fogelfeld', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04894-y']
914,31197730,Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network.,"BACKGROUND


Population-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters.
OBJECTIVE


To determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters.
DESIGN


3-arm pragmatic randomized controlled trial.
PARTICIPANTS


Current smokers ≥ 18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n = 5225) and recruited using automated phone calls.
INTERVENTIONS


One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral).
MEASUREMENTS


Proportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment.
KEY RESULTS


Of 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p < 0.001), cessation medication prescription (52% vs. 30%, p = 0.002), and counseling (47% vs. 9%, p < 0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
CONCLUSIONS


Smokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system-based or community-based program compared with usual care. The health system-based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03612895.",2019,"Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
","['18\xa0years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n\u2009=\u20095225) and recruited using automated phone calls', '639 individuals who responded to the proactive treatment offer, 233 consented', 'Current smokers ≥']","['One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral']","['cessation medication prescription', 'higher documentation of any smoking cessation treatment']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C3241966'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0765875,"Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalkhoran', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. skalkhoran@mgh.harvard.edu.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Inman', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jennifer H K', 'Initials': 'JHK', 'LastName': 'Kelley', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05079-3']
915,31220283,Interval Walking Improves Glycemic Control and Body Composition After Cancer Treatment: A Randomized Controlled Trial.,"CONTEXT


Patients with colorectal cancer have increased risk of metabolic diseases including diabetes. Exercise training may counteract metabolic dysregulation, but the impact of exercise training on glycemic control, including postprandial glycemia, has never been explored in patients with colorectal cancer.
OBJECTIVE


To examine the effects of home-based interval walking on aerobic and metabolic fitness and quality of life in patients with colorectal cancer.
DESIGN


Randomized controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Thirty-nine sedentary (<150 minutes moderate-intensity exercise per week) patients with stage I to III colorectal cancer who had completed primary treatment.
INTERVENTION


Home-based interval walking 150 min/wk or usual care for 12 weeks.
MAIN OUTCOME MEASURES


Changes from baseline to week 12 in maximum oxygen uptake (VO2peak) by cardiopulmonary exercise test, glycemic control by oral glucose tolerance test (OGTT), body composition by dual-energy x-ray absorptiometry scan, blood biochemistry, and quality of life.
RESULTS


Compared with control, interval walking had no effect on VO2peak [mean between-group difference: -0.32 mL O2 · kg-1 · min-1 (-2.09 to 1.45); P = 0.721] but significantly improved postprandial glycemic control with lower glucose OGTT area under the curve [-126 mM · min (-219 to -33); P = 0.009], 2-hour glucose concentration [-1.1 mM (-2.2 to 0.0); P = 0.056], and improved Matsuda index [1.94 (0.34; 3.54); P = 0.01]. Also, interval walking counteracted an increase in fat mass in the control group [-1.47 kg (-2.74 to -0.19); P = 0.025].
CONCLUSION


A home-based interval-walking program led to substantial improvements in postprandial glycemic control and counteracted fat gain in posttreatment patients with colorectal cancer, possibly providing an effective strategy for prevention of secondary metabolic diseases.",2019,"Compared to control, interval-walking had no effect on VO2peak (mean between-group difference: -0.32ml O2*kg-1*min-1 [-2.09; 1.45], p = 0.721) but significantly improved post-prandial glycaemic control with lower glucose OGTT-area under the curve (-126 mM*min [-219; -33], p=0.009), 2-hour glucose concentration (-1.1 mM [-2.2;0.0], p=0.056), and improved Matsuda index +1.94 [0.34; 3.54], p=0.019.","['colorectal cancer patients', 'Colorectal cancer patients', 'post-treatment colorectal cancer patients', 'after Cancer Treatment', 'Thirty-nine sedentary (less than 150 min moderate intensity exercise per week), stage I-III colorectal cancer patients, who had completed primary treatment']","['exercise training', 'Home-based interval-walking 150 min per week or usual care for 12 weeks', 'Exercise training']","['VO2peak', 'fat mass', '2-hour glucose concentration', 'VO2peak by cardiopulmonary exercise test; glycemic control by oral glucose tolerance test (OGTT); body composition by DXA-scan; blood biochemistry, and quality of life', 'Interval-Walking Improves Glycaemic Control and Body Composition']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}, {'cui': 'C0005768'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0034380'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",39.0,0.0555946,"Compared to control, interval-walking had no effect on VO2peak (mean between-group difference: -0.32ml O2*kg-1*min-1 [-2.09; 1.45], p = 0.721) but significantly improved post-prandial glycaemic control with lower glucose OGTT-area under the curve (-126 mM*min [-219; -33], p=0.009), 2-hour glucose concentration (-1.1 mM [-2.2;0.0], p=0.056), and improved Matsuda index +1.94 [0.34; 3.54], p=0.019.","[{'ForeName': 'Jesper F', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sundberg', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Osterkamp', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thorsen-Streit', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anette B', 'Initials': 'AB', 'LastName': 'Nielsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie K', 'Initials': 'CK', 'LastName': 'Olsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sissal S', 'Initials': 'SS', 'LastName': 'Djurhuus', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schauer', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kell', 'Initials': 'K', 'LastName': 'Østerlind', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter-Martin', 'Initials': 'PM', 'LastName': 'Krarup', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University, Herlev, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Vistisen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University, Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Tolver', 'Affiliation': 'Data Science Laboratory, Department of Mathematical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Hojman', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00590']
916,31264758,Effects of dapagliflozin on urinary metabolites in people with type 2 diabetes.,"AIM


To assess the effects of the sodium-glucose co-transporter-2 (SGLT2) inhibitor dapagliflozin on a pre-specified panel of 13 urinary metabolites linked to mitochondrial metabolism in people with type 2 diabetes and elevated urine albumin levels.
MATERIALS AND METHODS


Urine and plasma samples were used from a double-blind, randomized, placebo-controlled crossover trial in 31 people with type 2 diabetes, with an albumin:creatinine ratio >100 mg/g, and who were on a stable dose of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Dapagliflozin or placebo treatment periods each lasted 6 weeks, with a 6-week washout period in between. Urinary and plasma metabolites were quantified by gas-chromatography mass spectrometry, corrected for creatinine level, and then combined into a single-valued urinary metabolite index. Fractional excretion of the metabolites was calculated.
RESULTS


All 13 urinary metabolites were detectable. After 6 weeks of dapagliflozin therapy, nine of the 13 metabolites were significantly increased from baseline. The urinary metabolite index increased by 42% (95% confidence interval [CI] 8.5 to 85.6; P = .01) with placebo versus 121% (95% CI 69 to 189; P < .001) with dapaglifozin. The placebo-adjusted effect was 56% (95% CI 11 to 118; P = .012). In plasma, seven of the 13 metabolites were detectable, and none was modified by dapagliflozin.
CONCLUSIONS


Dapagliflozin significantly increased a panel of urinary metabolites previously linked to mitochondrial metabolism. These data support the hypothesis that SGLT2 inhibitors improve mitochondrial function, and improvements in mitochondrial function could be a mechanism for kidney protection. Future studies with longer treatment duration and clinical outcomes are needed to confirm the clinical impact of these findings.",2019,"The urinary metabolite index increased by 42% (95%CI: 8.5 - 85.6, p=0.01) with placebo compared to 121% (69 - 189, p<0.001) with dapaglifozin.","['patients with type 2 diabetes and elevated albuminuria', 'Urine and plasma samples', 'patients with type 2 diabetes', '31 patients with type 2 diabetes, albumin']","['Angiotensin Converting Enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB', 'placebo', 'Dapagliflozin or placebo', 'SGLT-2 inhibitor dapagliflozin', 'SGLT-2 inhibition', 'Dapagliflozin', 'dapagliflozin']","['Fractional excretion of the metabolites', 'mitochondrial function', 'urinary metabolite index', 'urinary metabolites', 'Urinary and plasma metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0042037'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",31.0,0.277249,"The urinary metabolite index increased by 42% (95%CI: 8.5 - 85.6, p=0.01) with placebo compared to 121% (69 - 189, p<0.001) with dapaglifozin.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Darshi', 'Affiliation': 'Division of Nephrology, UT Health Science Center San Antonio, San Antonio, Texas.'}, {'ForeName': 'Jiwan J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, UT Health Science Center San Antonio, San Antonio, Texas.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZiekenhuisGroep Twente, Almelo, The Netherlands.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Division of Nephrology, UT Health Science Center San Antonio, San Antonio, Texas.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13823']
917,32133931,Effects of incentivizing viral suppression in previously incarcerated adults living with HIV.,"Background:  The amount of HIV in a person's blood can be suppressed to an undetectable level through antiretroviral therapy medications (ART). Adhering to an ART regimen can improve a person's health and reduce HIV transmission. Despite these benefits, many people with HIV do not maintain the level of adherence required to achieve an undetectable viral load. This problem is particularly common among people who have been incarcerated. Objective:  To determine effects of incentivizing viral suppression in previously incarcerated adults with HIV. Methods:  Adults with HIV (N = 102) and detectable viral load (>200 copies/mL) were randomly assigned to a Usual Care or Incentive group. Usual Care participants did not earn incentives for viral suppression. Incentive participants earned incentives ($10/day maximum) for providing blood samples with a reduced or undetectable (<200 copies/mL) viral load. Assessments were conducted every 3 months. Results collected during the first year were aggregated and compared based on group assignment and incarceration history. Results:  Previously incarcerated participants in the Incentive group provided more (OR: 2.9; CI: 1.3-6.8;  p  <.05) blood samples with an undetectable viral load (69%) than those in the Usual Care group (41%). Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0;  p  <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%). Effects of incentives did not differ by incarceration history. Conclusions:  Incentivizing viral suppression can increase viral suppression (undetectable viral load) in people who have been incarcerated.",2020,Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0;  p  <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%).,"['Adults with HIV (N\u2009=\u2009102) and detectable viral load (>200 copies/mL', 'previously incarcerated adults living with HIV', 'previously incarcerated adults with HIV', 'people who have been incarcerated']","['incentivizing viral suppression', 'Usual Care or Incentive group']","[""person's health and reduce HIV transmission"", 'viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.147619,Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0;  p  <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%).,"[{'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pollock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rodewald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",HIV research & clinical practice,['10.1080/25787489.2020.1735816']
918,31314661,A Randomized Clinical Trial Comparing the Impact of a Web-Based Multimedia Intervention Versus an Educational Pamphlet on Patient Outcomes in Breast Cancer Survivors with Chronic Secondary Lymphedema.,"Objective:  The purpose of this study was to evaluate the effects of a Web-based Multimedia Intervention (WBMI) for breast cancer-related lymphedema (BCRL) patients on symptom burden, function, psychological well-being, costs, and arm volume.  Methods:  Women with BCRL were randomized to intervention ( n  = 80) or control ( n  = 80) groups. The WBMI offered 12 modules, each of which took about 30 minutes to complete. The Pamphlet took about 2 hours to read. Data on symptom burden, psychological well-being, function, and costs were collected preintervention; and 1, 3, 6, and 12 months postintervention. A subgroup of 45 regional patients had arm extracellular fluid measured by bioimpedance at baseline and at 3, 6, and 12 months postintervention. Intervention perceived value was also captured.  Results:  A statistically significant difference ( p  = 0.011) was observed for rates of intervention completion, WBMI (58%), and Pamphlet (77%). With the exception of the number of biobehavioral symptoms (mood), no statistically significant differences between groups in symptom reduction were apparent between baseline and 1 or 12 months (effect sizes = 0.05-0.28,  p  > 0.05) based on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A). No statistically significant differences between the groups were observed for changes in other variables. The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  Conclusions:  WBMI participants experienced improved biobehavioral symptoms and higher perceived quality of information. The lack of significant differences on other variables may be due to the high percentage of participants who did not complete the WBMI.",2020,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"['breast cancer-related lymphedema (BCRL) patients on', 'Women with BCRL', 'Breast Cancer Survivors with Chronic Secondary Lymphedema']","['Web-Based Multimedia Intervention', 'Web-based Multimedia Intervention (WBMI', 'Educational Pamphlet']","['number of biobehavioral symptoms (mood', 'Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A', 'symptom reduction', 'WBMI', 'biobehavioral symptoms and higher perceived quality of information', 'symptom burden, psychological well-being, function, and costs', 'rates of intervention completion, WBMI', 'symptom burden, function, psychological well-being, costs, and arm volume']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema (disorder)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",12.0,0.107559,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Davis', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'Sinclair', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7676']
919,32208006,Use of an Online Crowdsourcing Platform to Assess Patient Comprehension of Radiology Reports and Colloquialisms.,"OBJECTIVE.  The purpose of this study was to use an online crowdsourcing platform to assess patient comprehension of five radiology reporting templates and radiology colloquialisms.  MATERIALS AND METHODS.  In this cross-sectional study, participants were surveyed as patient surrogates using a crowdsourcing platform. Two tasks were completed within two 48-hour time periods. For the first crowdsourcing task, each participant was randomly assigned a set of radiology reports in a constructed reporting template and subsequently tested for comprehension. For the second crowdsourcing task, each participant was randomly assigned a radiology colloquialism and asked to indicate whether the phrase indicated a normal, abnormal, or ambivalent finding.  RESULTS.  A total of 203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication. The payment totaled $31.96. Of 812 radiology reports read, 384 (47%) were correctly interpreted by the patient surrogates. Patient surrogates had higher rates of comprehension of reports written in the patient summary (57%,  p  < 0.001) and traditional unstructured in combination with patient summary (51%,  p  = 0.004) formats than in the traditional unstructured format (40%). Most of the patient surrogates (114/203 [56%]) expressed a preference for receiving a full radiology report via an electronic patient portal. Several radiology colloquialisms with modifiers such as ""low,"" ""underdistended,"" and ""decompressed"" had low rates of comprehension.  CONCLUSION.  Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research. Patient summaries can help increase patient comprehension of radiology reports. Radiology colloquialisms are likely to be misunderstood by patients.",2020,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","['participants were surveyed as patient surrogates using a crowdsourcing platform', '203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication']",[],['rates of comprehension of reports written'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0034036', 'cui_str': 'Publications'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",203.0,0.0752139,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","[{'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Zafar', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Tessa S', 'Initials': 'TS', 'LastName': 'Cook', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22202']
920,31318121,Teaching medical students digital rectal examination: a randomized study of simulated model vs rectal examination volunteers.,"OBJECTIVES


To determine if using a digital rectal examination (DRE) human volunteer improves medical students' confidence in performing DRE in comparison to using a simulated model alone.
PARTICIPANTS AND METHODS


Medical students underwent randomization into one of two groups: a control group who underwent standard teaching and an intervention group who underwent standard teaching plus further tuition involving a DRE volunteer. Standard teaching involved a 30-min lecture and a practice DRE on a simulation model. The intervention group additionally observed a tutor demonstrating DRE on a volunteer, then conducted a DRE themselves under supervision. Before and after teaching, both groups completed a survey comprised of three questions. The primary endpoint was confidence in performing a DRE, which was assessed according to the sum of the scores from the three questions.
RESULTS


In total, 48 students were randomized, 22 to the control group and 26 to the intervention group. The groups were well matched prior to teaching DRE (P = 0.76) After the DRE tutorial, students in the intervention group were more confident in knowing the indications for DRE (P = 0.001), more confident in their technique for performing DRE (P < 0.001) and more confident in their ability to assess findings accurately at DRE (P < 0.001). The primary outcome measure, overall confidence (sum of the scores from all three questions) in performing DRE, was significantly better in the intervention group (score 10/15 vs 14/15; P < 0.001).
CONCLUSION


This study showed that teaching DRE with the assistance of volunteer patients improves inexperienced students' confidence in performing DRE, and the incorporation of such training should be considered in the DRE education programme.",2019,The groups were well matched prior to teaching DRE (P = 0.76),"['rectal examination volunteers', 'Teaching medical students digital rectal examination', '48 students were randomized, 22 to the control group and 26 to the intervention group', 'Medical students underwent randomization into one of two groups: a']","['digital rectal examination (DRE) human volunteer', 'teaching DRE', 'control group who underwent standard teaching and an intervention group who underwent standard teaching plus further tuition involving a DRE volunteer']","['overall confidence', 'confidence in performing a DRE']","[{'cui': 'C0199900', 'cui_str': 'Rectal examination (procedure)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",,0.0308866,The groups were well matched prior to teaching DRE (P = 0.76),"[{'ForeName': 'Manish I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Kakala', 'Affiliation': 'Department of Urology, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Beattie', 'Affiliation': 'Department of Urology, Westmead Hospital, Westmead, NSW, Australia.'}]",BJU international,['10.1111/bju.14778']
921,32062371,Remitted depression and cognition in HIV: The role of cortisol and inflammation.,"In major depressive disorder (MDD) and remitted MDD (rMDD) alterations in cortisol and inflammation are associated with cognitive difficulties, but these relationships have not been investigated in HIV. We used secondary data from a placebo-controlled, cross-over study of cognitive performance following a probe of the hypothalamic-pituitary-adrenal (HPA) axis (low dose hydrocortisone; LDH 10 mg) in 65 people with HIV (PWH; 36 women). Using placebo data, we examined sex-specific associations between two biomarkers - basal afternoon salivary cortisol and salivary inflammatory cytokines - cognition, and rMDD. Salivary cortisol and inflammatory biomarkers were sampled across the 5 -h study. The panel of inflammatory markers included interleukin (IL)-6, IL-8, IL-1β, tumor necrosis factor-(TNF)-α, CRP, interferon gamma-induced protein (IP-10), monocyte chemotactic protein (MCP)-1, monokine induced by interferon (MIG), matrix metalloproteinase MMP-9, and MMP-1. Learning, memory, attention/concentration, and executive function were assessed 30 min and 4 h after the placebo intervention; visuospatial ability was also assessed 30 min after the placebo intervention. For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory. For men and women with HIV, basal inflammatory cytokines were higher in rMDD versus noMDD groups, but were negatively related to cognition independent of rMDD status. Cortisol and cytokines relate to cognition in PWH, but the associations depended on sex, rMDD status, and their interaction.",2020,"For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory.",['65 people with HIV (PWH; 36 women'],['hypothalamic-pituitary-adrenal (HPA) axis (low dose hydrocortisone; LDH'],"['biomarkers - basal afternoon salivary cortisol and salivary inflammatory cytokines - cognition, and rMDD', 'Salivary cortisol and inflammatory biomarkers', 'interleukin (IL)-6, IL-8, IL-1β, tumor necrosis factor-(TNF)-α, CRP, interferon gamma-induced protein (IP-10), monocyte chemotactic protein (MCP)-1, monokine induced by interferon (MIG), matrix metalloproteinase MMP-9, and MMP-1', 'basal inflammatory cytokines', 'Learning, memory, attention/concentration, and executive function', 'basal cortisol concentrations']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0026484', 'cui_str': 'Monokines'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",65.0,0.124238,"For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory.","[{'ForeName': 'Leah H', 'Initials': 'LH', 'LastName': 'Rubin', 'Affiliation': 'Department of Neurology and Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States. Electronic address: lrubin1@jhmi.edu.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': 'Blood Systems Research Institute, San Francisco, CA, United States.'}, {'ForeName': 'Gretchen N', 'Initials': 'GN', 'LastName': 'Neigh', 'Affiliation': 'Departments of Anatomy and Neurobiology, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Weber', 'Affiliation': 'CORE Center, Cook County Health and Hektoen Institute of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Pauline M', 'Initials': 'PM', 'LastName': 'Maki', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States; Department of Psychology, University of Illinois at Chicago, Chicago, IL, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104609']
922,32068002,Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial.,"BACKGROUND


Elamipretide, a novel mitochondrial modulating agent, improves myocardial energetics; however, it is unknown whether this mechanistic benefit translates into improved cardiac structure and function in heart failure (HF) with reduced ejection fraction (HFrEF). The objective of this study was to evaluate the effects of multiple subcutaneous doses of elamipretide on left ventricular end systolic volume (LVESV) as assessed by cardiac magnetic resonance imaging.
METHODS


We randomized 71 patients with HFrEF (LVEF ≤ 40%) in a double-blind, placebo-controlled trial in a 1:1:1 ratio to receive placebo, 4 mg or 40 mg elamipretide once daily for 28 consecutive days.
RESULTS


The mean age (standard deviation) of the study population was 65 ± 10 years, 24% were females, and the mean EF was 31% ± 7%. The change in LVESV from baseline to week 4 was not significantly different between elamipretide 4 mg (89.4 mL to 85 mL; difference, -4.4 mL) or 40 mg (77.9 mL to 76.6 mL; difference, -1.2 mL) compared with placebo (77.7 mL to 74.6 mL; difference, -3.8 mL) (4 mg vs placebo: difference of means, -0.3; 95% CI, -4.6 to 4.0; P  =  0.90; and 40 mg vs placebo: difference of means, 2.3; 95% CI, -1.9 to 6.5; P  =  0.28). Also, no significant differences in change in LVESV and LVEF were observed between placebo and either of the elamipretide groups. Rates of any study drug-related adverse events were similar in the 3 groups.
CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in patients with stable HFrEF compared with placebo.",2020,"CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in stable HFrEF patients compared with placebo.","['Mean age (SD) of the study population was 65±10 years, 24% were females, and mean EF was 31±7', 'Seventy-one', 'Patients with Heart Failure with Reduced Ejection Fraction']","['elamipretide', 'placebo', 'placebo, 4 mg or 40 mg elamipretide', 'cardiac magnetic resonance imaging (MRI', 'HFrEF (LVEF ≤ 40', 'Elamipretide']","['change in LVESV', 'adverse events', 'left ventricular end diastolic volume and left ventricular ejection fraction', 'left ventricular end systolic volume (LVESV', 'LVESV', 'Left Ventricular Function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4279623'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.741968,"CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in stable HFrEF patients compared with placebo.","[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Missisippi, USA.'}, {'ForeName': 'Muhammad Shahzeb', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Cook County Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Savina', 'Initials': 'S', 'LastName': 'Nodari', 'Affiliation': 'Cardiology Section, Department of Clinical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, USA.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pieske-Kraigher', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Hani N', 'Initials': 'HN', 'LastName': 'Sabbah', 'Affiliation': 'Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiovascular Department, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the Cardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Stealth BioTherapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Gheorghiade', 'Affiliation': 'Department of Medicine, Bluhm Cardiovascular Institute, Northwestern University Feingerg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece. Electronic address: geros@otenet.gr.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.02.001']
923,31234642,Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial.,"BACKGROUND


Calcitonin gene-related peptide plays an important role in migraine pathophysiology. We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine.
OBJECTIVE


To determine the safety, tolerability, and effectiveness of four dose levels of eptinezumab and to inform the phase 3 development program.
METHODS


This was a phase 2b, parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial. Men and women (N = 616) aged 18-55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year. During the 28-day screening period, patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks as recorded in the electronic diary. Patients were assigned in a 1:1:1:1:1 ratio to eptinezumab 300, 100, 30, 10 mg or placebo, administered as a single IV infusion. The primary endpoint was the percentage of patients with a ≥75% decrease in monthly migraine days over weeks 1-12 compared with the 28-day screening period.
RESULTS


The ≥75% migraine responder rates over weeks 1-12 for eptinezumab 300, 100, 30, and 10 mg were 33.3%, 31.4%, 28.2%, and 26.8%, respectively, versus 20.7% for placebo ( p  = 0.033, 0.072, 0.201, 0.294 vs. placebo). Secondary efficacy endpoints (e.g. ≥50% responder rate, change from baseline in frequency of migraine/headache days, and percentage of severe migraines) had results favoring the three higher eptinezumab doses versus placebo. Eptinezumab was well tolerated and adverse event rates were similar to placebo.
CONCLUSIONS


The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02275117.",2019,"The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
","['chronic migraine', 'Men and women (N\u2009=\u2009616) aged 18-55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year']","['Eptinezumab', 'eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody', 'eptinezumab', 'placebo']","['migraine responder rates', 'tolerated and adverse event rates', 'safety, tolerability, and effectiveness', 'frequency of migraine/headache days, and percentage of severe migraines', 'percentage of patients with a ≥75% decrease in monthly migraine days']","[{'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]",616.0,0.663503,"The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': '1 Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': '2 Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': '3 Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""4 NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Biondi', 'Affiliation': '6 Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': '7 Pacific Northwest Statistical Consulting, Woodinville, WA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': '6 Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': '8 Alder BioPharmaceuticals Ltd, Dublin, Ireland.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419858355']
924,31127818,Effect of Macronutrient Type and Gastrointestinal Release Site on PYY Response in Normal Healthy Subjects.,"BACKGROUND AND AIMS


Enteroendocrine L cells release satiety inducing hormones in response to stimulation by luminal macronutrients. We sought to profile the differential effect of macronutrient type and site of release on circulating concentrations of the L cell-derived enteroendocrine hormone peptide tyrosine tyrosine (amino acids 1 to 36) (PYY).
MATERIALS AND METHODS


Eight healthy volunteers were recruited to a randomized, double-blinded, six-way crossover study. At each visit, the participants consumed a 500-kcal drink containing carbohydrate, protein, or fat in either gastric or small intestinal release formulations. Plasma PYY concentrations and hunger ratings were assessed for 3 hours after consumption of the test drink. The food intake was recorded thereafter at an ad libitum lunch.
RESULTS


Microcapsular formulations targeting the distal small intestinal delivery of fat, but not carbohydrate or protein, markedly enhance PYY release relative to macronutrient delivery in gastric release formulations. Food intake at an ad libitum meal was lowest after consumption of the formulation releasing fat at the distal small intestine.
CONCLUSION


Targeting of fat to the distal small intestine in delayed release microcapsules enhanced PYY release and was associated with reductions in food intake.",2019,Targeting of fat to the distal small intestine in delayed release microcapsules enhances PYY release and is associated with reductions in food intake.,"['Eight healthy volunteers', 'Normal Healthy Subjects']","['500 kilocalorie drink containing either carbohydrate, protein or fat, in either gastric or small intestinal release formulations', 'Macronutrient Type and Gastrointestinal Release Site']","['Plasma PYY concentrations and hunger ratings', 'Food intake']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",8.0,0.121913,Targeting of fat to the distal small intestine in delayed release microcapsules enhances PYY release and is associated with reductions in food intake.,"[{'ForeName': 'Aisling M', 'Initials': 'AM', 'LastName': 'Mangan', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al Najim', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'McNamara', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Martin', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Antanaitis', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sinéad B', 'Initials': 'SB', 'LastName': 'Bleiel', 'Affiliation': 'AnaBio Technologies Ltd., R&D Centre of Excellence and Production, Carrigtwohill, Ireland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kent', 'Affiliation': 'AnaBio Technologies Ltd., R&D Centre of Excellence and Production, Carrigtwohill, Ireland.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Neil G', 'Initials': 'NG', 'LastName': 'Docherty', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-01697']
925,31314920,Ungual warts: comparison of treatment with intralesional bleomycin and electroporation in terms of efficacy and safety.,"BACKGROUND


Ungual warts are considered the most common benign nail tumour, and they are caused by the human papillomavirus. Despite the numerous treatments reported in the medical literature, ungual warts are considered frustrating, with high relapse rates and a potential risk of nail dystrophy. Bleomycin is a therapeutic option showing a good safety profile and high cure rates.
OBJECTIVE


To evaluate the efficacy of electrochemotherapy using intralesional bleomycin for the treatment of ungual warts in comparison with intralesional bleomycin alone and describe the side-effects related to the use of both techniques.
METHODS


This was a prospective, randomized, double-blind, controlled clinical trial. Forty-four 18- to 60-year-old female and male patients with ungual warts of only one finger were included. The patients were divided into two treatment groups: GA - intralesional bleomycin; and GB - electroporation and intralesional bleomycin. Following a single application, the patients were followed up for 180 days.
RESULTS


The patients' mean age was 36 years for GA and 37 years for GB. Most patients were female (68%). Of 22 patients in GA completing the study, 11 (50%) achieved the cure, while 18 (85.7%) of 21 patients completing the study in GB showed cure. A significant association of patients with or without cure after the GA and GB treatments (P = 0.022) was observed. None of the patients in either group had systemic side-effects. Independent of the technique used, all the participants considered the adverse effects tolerable.
CONCLUSION


The intralesional use of bleomycin associated with electroporation for the treatment of ungual warts (both periungual and subungual) showed a statistically superior cure when compared with intralesional bleomycin alone. Side-effects were more frequently observed in the electrochemotherapy with bleomycin group than in the bleomycin monotherapy group.",2019,A significant association of patients with or without cure after the GA and GB treatments (P = 0.022) was observed.,"['Forty-four 18- to 60-year-old female and male patients with ungual warts of only one finger were included', ""patients' mean age was 36\xa0years for GA and 37\xa0years for GB"", 'ungual warts in comparison with']","['bleomycin monotherapy', 'Bleomycin', 'intralesional bleomycin', 'bleomycin', 'intralesional bleomycin and electroporation', 'GA - intralesional bleomycin; and GB - electroporation and intralesional bleomycin', 'electrochemotherapy', 'electrochemotherapy with bleomycin']","['systemic side-effects', 'adverse effects tolerable', 'Side-effects', 'efficacy and safety']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0678054', 'cui_str': 'Electroporation Therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0425155,A significant association of patients with or without cure after the GA and GB treatments (P = 0.022) was observed.,"[{'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Di Chiacchio', 'Affiliation': 'Hospital do Servidor Público Municipal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Di Chiacchio', 'Affiliation': 'Hospital do Servidor Público Municipal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Criado', 'Affiliation': 'Faculdade de Medicina do ABC, Santo Andre, Brazil.'}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'Brunner', 'Affiliation': 'Universidade Paulista, São Paulo, Brazil.'}, {'ForeName': 'M V R', 'Initials': 'MVR', 'LastName': 'Suaréz', 'Affiliation': 'Hospital do Servidor Público Municipal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Belda Junior', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.15815']
926,31313855,A place of understanding: Patients' lived experiences of participating in a sexual rehabilitation programme after heart disease.,"AIMS AND OBJECTIVES


The aim of this project was to explore the lived experience of participating in a nonpharmacological sexual rehabilitation programme.
BACKGROUND


In the healthcare system, patients are important stakeholders, and their experience and knowledge are essential to include when evaluating rehabilitation programmes. Patient experiences with participating in sexual rehabilitation for cardiovascular patients have not yet been investigated.
METHODS


Ten qualitative interviews were conducted with male patients from a randomised controlled trial investigating the effect of a 12-week rehabilitation programme focusing on sexuality. The analysis was inspired by Paul Ricoeur's theory of interpretation. Analysis consisted of three levels: (i) naive reading, (ii) structural analysis and (iii) critical interpretation and discussion. The theoretical framework reflects aspects of behavioural theory of social cognitive theory developed by Albert Bandura and his concept of self-efficacy.
RESULTS


The findings are presented as themes extracted from the structural analysis and interpreted in the critical interpretation and express the way in which cardiovascular patients experience participating in a sexual rehabilitation programme. Three themes were identified reflecting the intervention to be a special place of understanding, describing the intervention as a supporting atmosphere and finally expressing the intervention as empowering sexuality.
CONCLUSIONS


Participating in the sexual rehabilitation programme was experienced as efficient, valuable, motivating and safe, but dependent on a professional setting. The intervention developed participants' self-efficacy with regard to their sexual performance and relationship.
RELEVANCE TO CLINICAL PRACTICE


The findings highlight the importance of a professional setting including certain competencies such as humour and professional skills when handling the after-care of cardiovascular patients with sexual problems.",2020,"Analysis consisted of three levels: (i) naive reading, (ii) structural analysis and (iii) critical interpretation and discussion.","['lived experience of participating in a nonpharmacological sexual rehabilitation programme', 'cardiovascular patients experience participating in a sexual rehabilitation programme', "" Patients' lived experiences of participating in a sexual rehabilitation programme after heart disease"", 'Ten qualitative interviews were conducted with male patients', 'cardiovascular patients with sexual problems', 'Patient experiences with participating in sexual rehabilitation for cardiovascular patients']","['three levels: (i) naive reading, (ii) structural analysis and (iii) critical interpretation and discussion', 'rehabilitation programme focusing on sexuality']",[],"[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0856619', 'cui_str': 'Sexual problem'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis (procedure)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}]",[],10.0,0.0300928,"Analysis consisted of three levels: (i) naive reading, (ii) structural analysis and (iii) critical interpretation and discussion.","[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Palm', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ann-Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'The National Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Giraldi', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Selina Kikkenborg', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12738']
927,30917364,Modifying Effect of Statins on Fatal Outcomes in Chronic Kidney Disease Patients in the Systolic Blood Pressure Intervention Trial: A Post Hoc Analysis.,"BACKGROUND


Management of chronic kidney disease (CKD) patients includes efforts directed toward modifying traditional cardiovascular risk factors. Such efforts include optimal management of hypertension together with the initiation of statin therapy.
METHODS


In this observational study, we determine the modifying effect of statins on the relationship of systolic blood pressure (SBP) goal with mortality and other outcomes in patients with CKD participating in a clinical trial. At baseline, 2,646 CKD patients (estimated glomerular filtration rate < 60 mL/min/1.73 m2) were randomized to an intensive SBP goal < 120 mm Hg or standard SBP goal <140 mm Hg. One thousand two hundred and seventy-three were not on statin, 1,354 were on a statin, and in 19 the use of statin was unknown. The 2 primary outcomes were all-cause mortality and cardiovascular disease (CVD) mortality.
RESULTS


The relationships of SBP goal with all-cause mortality (interaction p = 0.009) and cardiovascular (CV) mortality (interaction p = 0.021) were modified by the use of statin after adjusting for age, gender, race, CVD history, smoking, aspirin use, and blood pressure at baseline. In the statin group, targeting SBP to < 120 mm Hg compared to SBP < 140 mm Hg significantly reduced the risk of all-cause mortality (adjusted hazard ratio [aHR] 0.44 [0.28-0.71]; event rates 1.16 vs. 2.5 per 100 patient-years) and CV mortality (aHR 0.29 [0.12-0.74]; event rates 0.28 vs. 0.92 per 100 patient-years) after a median follow-up of 3.26 years. In the non-statin group, the risk of all-cause mortality (aHR 1.07 [0.69-1.66]; event rates 2.01 vs. 1.94 per 100 patient-years) and CV mortality (aHR 1.42 [0.56-3.59]; event rates 0.52 vs. 0.41 per 100 patient-years) were not significantly different in both SBP goal arms.
CONCLUSION


The combination of statin therapy and intensive SBP management leads to improved survival in hypertensive patients with CKD.",2019,"The relationships of SBP goal with all-cause mortality (interaction p = 0.009) and cardiovascular (CV) mortality (interaction p = 0.021) were modified by the use of statin after adjusting for age, gender, race, CVD history, smoking, aspirin use, and blood pressure at baseline.","['2,646 CKD patients (estimated glomerular filtration rate < 60 mL/min/1.73 m2', 'chronic kidney disease (CKD) patients', 'Chronic Kidney Disease Patients in the Systolic Blood Pressure Intervention Trial', 'One thousand two hundred and seventy-three were not on statin, 1,354 were on a statin, and in 19 the use of statin was unknown', 'hypertensive patients with CKD', 'patients with CKD participating in a clinical trial']","['Statins', 'statins', 'statin therapy and intensive SBP management']","['survival', 'Fatal Outcomes', 'cardiovascular (CV) mortality', 'cause mortality and cardiovascular disease (CVD) mortality', 'CV mortality', 'risk of all-cause mortality', 'systolic blood pressure (SBP) goal with mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3811844'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",2646.0,0.0909892,"The relationships of SBP goal with all-cause mortality (interaction p = 0.009) and cardiovascular (CV) mortality (interaction p = 0.021) were modified by the use of statin after adjusting for age, gender, race, CVD history, smoking, aspirin use, and blood pressure at baseline.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rivera', 'Affiliation': 'Katz Family and Division of Nephrology and Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Division of Population Health and Computational Medicine, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Maritza', 'Initials': 'M', 'LastName': 'Suarez', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Miami Miller of School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Contreras', 'Affiliation': 'Katz Family and Division of Nephrology and Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA, gcontrer@med.miami.edu.'}]",American journal of nephrology,['10.1159/000499188']
928,31306043,Icosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides.,"Objective : Patients with chronic kidney disease (CKD) have increased cardiovascular disease (CVD) risk, likely driven by atherogenic and inflammatory markers beyond low-density lipoprotein cholesterol (LDL-C). The objective of this hypothesis-generating post hoc subgroup analysis was to explore the effects of icosapent ethyl at 2 or 4 g/day (prescription pure ethyl ester of the omega-3 fatty acid eicosapentaenoic acid [EPA]) on atherogenic lipid, apolipoprotein, inflammatory parameters (high-sensitivity C-reactive protein [hsCRP], lipoprotein-associated phospholipase A 2  [Lp-PLA 2 ]), and oxidative parameters (oxidized-LDL [ox-LDL]) in statin-treated patients from ANCHOR with stage 3 CKD. Methods : The 12-week ANCHOR study evaluated icosapent ethyl in 702 statin-treated patients at increased CVD risk with triglycerides (TG) 200-499 mg/dL despite controlled LDL-C (40-99 mg/dL). This post-hoc analysis included patients from ANCHOR with stage 3 CKD (estimated glomerular filtration rate [eGFR] ≤60 mL/min/1.73 m 2  for ≥3 months) randomized to icosapent ethyl 4 g/day (n = 19), 2 g/day (n = 30), or placebo (n = 36). Results : At the prescription dose of 4 g/day, icosapent ethyl significantly reduced TG (-16.9%;  P  = 0.0074) and other potentially atherogenic lipids/lipoproteins, ox-LDL, hsCRP, and Lp-PLA 2 , and increased plasma and red blood cell EPA levels (+879% and +579%, respectively; both  P  < 0.0001) versus placebo. Icosapent ethyl did not significantly alter eGFR or serum creatinine. Safety and tolerability were similar to placebo. Conclusions : In patients with stage 3 CKD at high CVD risk with persistent high TG despite statins, icosapent ethyl 4 g/day reduced potentially atherogenic and other cardiovascular risk factors without raising LDL-C, with safety similar to placebo. These findings suggest prospective investigation may be warranted.",2019,Icosapent ethyl did not significantly alter eGFR or serum creatinine.,"['patients from ANCHOR with stage 3 CKD (estimated glomerular filtration rate [eGFR', 'Objective : Patients with chronic kidney disease (CKD', '≤60', 'statin-treated patients from ANCHOR with stage 3 CKD', '702 statin-treated patients at increased CVD risk with triglycerides (TG', 'high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides']","['Icosapent ethyl', 'placebo', 'icosapent ethyl at 2 or 4\xa0g/day (prescription pure ethyl ester of the omega-3 fatty acid eicosapentaenoic acid [EPA']","['TG', 'eGFR or serum creatinine', 'atherogenic markers', 'potentially atherogenic lipids/lipoproteins, ox-LDL, hsCRP, and Lp-PLA 2 , and increased plasma and red blood cell EPA levels', 'atherogenic lipid, apolipoprotein, inflammatory parameters (high-sensitivity C-reactive protein [hsCRP], lipoprotein-associated phospholipase A 2  [Lp-PLA 2 ]), and oxidative parameters (oxidized-LDL [ox-LDL', 'Safety and tolerability', 'cardiovascular disease (CVD) risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0914069', 'cui_str': '1-Alkyl-2-acetylglycerophosphocholine Esterase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0031672', 'cui_str': 'Phospholipases A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",702.0,0.356039,Icosapent ethyl did not significantly alter eGFR or serum creatinine.,"[{'ForeName': 'Krishnaswami', 'Initials': 'K', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Institute of Congestive Heart Failure, Abrazo Arizona Heart Hospital, Phoenix, AZ, USA.'}, {'ForeName': 'Harold M', 'Initials': 'HM', 'LastName': 'Szerlip', 'Affiliation': 'Nephrology Division and Nephrology Fellowship Program, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.'}, {'ForeName': 'Sephy', 'Initials': 'S', 'LastName': 'Philip', 'Affiliation': 'Medical Affairs, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Ralph T', 'Initials': 'RT', 'LastName': 'Doyle', 'Affiliation': 'Clinical Development, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Juliano', 'Affiliation': 'Clinical Development, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Granowitz', 'Affiliation': 'Medical Affairs, Amarin Pharma Inc., Bedminster, NJ, USA.'}]",Postgraduate medicine,['10.1080/00325481.2019.1643633']
929,31299447,Placebo mechanisms in depression: An experimental investigation of the impact of expectations on sadness in female participants.,"INTRODUCTION


We aimed to examine whether drug-associated expectations have an impact on the experience of sadness. We hypothesized that participants who received an active placebo nasal spray (but were told that it was an antidepressant that would protect them from experiencing negative emotions) would become less sad than the control groups.
METHODS


128 healthy female participants were randomly allocated to one of four groups: the experimental group, which received an active placebo and the expectancy-modifying instructions (""Protection: the spray protects from experiencing negative emotions"", n = 32), or one of three different control groups (""Sensitization"": the spray sensitizes to negative emotions"", n = 31; ""Placebo: the spray is a placebo"", n = 32; and ""Control: no nasal spray"", n = 32) RESULTS: In line with our hypotheses, the experimental group experienced significantly less sadness after having watched a sadness provoking film sequence compared to the three control groups, with medium- to large effect sizes (Hedge´s gs 0.59-0.87).
DISCUSSION


Our results suggest that sadness can be significantly influenced by placebos in the short-term. Our study further suggests that knowledge about the effect of placebos on depressive symptoms should be utilized in clinical practice. However, depression is a complex disorder and antidepressants address a wide range of symptoms associated with depression such as suicidal thoughts, disturbed sleep and loss of energy. Further research on the placebo effects associated with the antidepressant treatment is needed.
LIMITATIONS


concern generalizability to treatment because sadness is only one potential symptom of depression and antidepressants often also address other symptoms.",2019,"In line with our hypotheses, the experimental group experienced significantly less sadness after having watched a sadness provoking film sequence compared to the three control groups, with medium- to large effect sizes (Hedge´s gs 0.59-0.87).
","['128 healthy female participants', 'female participants', 'participants who received an', 'depression']","['active placebo nasal spray', 'placebo"", n\u202f=\u202f32; and ""Control: no nasal spray', 'placebos', 'active placebo and the expectancy-modifying instructions (""Protection: the spray protects from experiencing negative emotions"", n\u202f=\u202f32), or one of three different control groups (""Sensitization"": the spray sensitizes to negative emotions"", n\u202f=\u202f31; ""Placebo', 'Placebo']",[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}]",[],128.0,0.116797,"In line with our hypotheses, the experimental group experienced significantly less sadness after having watched a sadness provoking film sequence compared to the three control groups, with medium- to large effect sizes (Hedge´s gs 0.59-0.87).
","[{'ForeName': 'Glombiewski Julia', 'Initials': 'GJ', 'LastName': 'Anna', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, University of Koblenz-Landau, Ostbahnstr. 10, 76829 Landau, Germany. Electronic address: glombiewski@uni-landau.de.'}, {'ForeName': 'Rheker', 'Initials': 'R', 'LastName': 'Julia', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Wittkowski', 'Initials': 'W', 'LastName': 'Julia', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Rebstock', 'Initials': 'R', 'LastName': 'Lea', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Rief', 'Initials': 'R', 'LastName': 'Winfried', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2019.06.070']
930,31283891,Efficacy and Safety of Topical Chloroquine in Mild to Moderate Dry Eye Disease.,"Purpose : To evaluate the role of topical chloroquine (CHQ) as an adjunct to topical lubricants in the management of mild-moderate dry eye disease (DED) Methods : Prospective comparative pilot study allocated 150 patients with symptoms of mild to moderate DED to receive topical CMC 0.5% three times a day (group I, n = 75) or topical CHQ 0.03% twice a day with carboxymethylcellulose (CMC) 0.5% three times a day (group II, n = 75), for three months. Primary outcome measures were ocular surface disease index (OSDI) score and conjunctival impression cytology at 3 months. Secondary outcome measures were TBUT, Schirmer's test, ocular surface staining and any adverse effects at 3 months. Follow up was performed at 1 and 3 months. Results : At three months, the OSDI score was significantly better in the CHQ group as compared with the CMC group (CMC-18.36 ± 4.03 (SD), CHQ group- 15.9 ± 5.18 (SD);  p  = .002). Nelson's score was 0.92 ± 0.69 (SD) in the CHQ group as compared with 1.60 ± 0.77 (SD) in the CMC group ( p  < .001). Abnormal impression cytology was observed in 20% cases in the CHQ group as compared with 61.3% cases in CMC group ( p  < .001). A significant correlation was observed between Nelson's score and OSDI (Spearman's rho correlation coefficient 0.414,  p  < .001). TBUT, Schirmer test and ocular surface staining were significantly better in the CHQ group ( p  < .001). No adverse effects were observed in any group. Conclusion : Topical chloroquine is a useful adjunct to topical lubricants in the management of DED as it decreases the underlying chronic inflammation and helps maintain ocular surface stability.",2019,Schirmer test and ocular surface staining were significantly better in the CHQ group (p<0.001).,"['150 patients with symptoms of mild to moderate DED to receive', 'mild-moderate dry eye disease (DED)  Methods ', 'Mild to Moderate Dry Eye Disease']","['CHQ', 'Topical Chloroquine', 'Topical chloroquine', 'topical CMC', 'topical CHQ 0.03% twice a day with carboxymethylcellulose (CMC', 'topical chloroquine (CHQ', 'CMC']","[""TBUT, Schirmer's test, ocular surface staining and any adverse effects"", 'Schirmer test and ocular surface staining', 'OSDI score', 'adverse effects', 'Abnormal impression cytology', 'ocular surface disease index (OSDI) score and conjunctival impression cytology', 'Efficacy and Safety']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0007068', 'cui_str': 'thylose'}]","[{'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",150.0,0.0508524,Schirmer test and ocular surface staining were significantly better in the CHQ group (p<0.001).,"[{'ForeName': 'Jeewan S', 'Initials': 'JS', 'LastName': 'Titiyal', 'Affiliation': 'Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ruchita', 'Initials': 'R', 'LastName': 'Falera', 'Affiliation': 'Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashima', 'Initials': 'A', 'LastName': 'Bharghava', 'Affiliation': 'Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramkishor', 'Initials': 'R', 'LastName': 'Sah', 'Affiliation': 'Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Ocular Pathology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institutes of Medical Sciences, New Delhi, India.'}]",Current eye research,['10.1080/02713683.2019.1641824']
931,31297968,Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial.,"AIM


To assess the addition of linagliptin as an alternative to insulin uptitration in older people with type 2 diabetes on stable insulin therapy.
MATERIALS AND METHODS


This phase 4, randomized, multicentre, double-blinded, placebo-controlled, 24-week study recruited individuals on stable insulin, with baseline HbA1c 7.0%-10.0%, aged ≥60 years and body mass index ≤45 kg/m 2  . HbA1c and fasting plasma glucose were measured at study visits, and participants assessed glycaemic control with a self-monitoring blood glucose device. Adverse events (AEs) were reported during the study.
RESULTS


Three hundred and two participants were randomized 1:1 to linagliptin 5 mg qd and placebo, with one third of patients from Japan. Study population age and HbA1c (baseline mean ± SD) were 72.4 ± 5.4 years and 8.2 ± 0.8%, respectively; ~80% of participants were aged ≥70 years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate <60 mL/min/1.73 m 2  ; and half had been diagnosed with diabetes for >15 years. Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01). Linagliptin versus placebo was well tolerated, with similar incidences of AEs, including clinically important hypoglycaemia (blood glucose <54 mg/dL) or severe hypoglycaemia.
CONCLUSIONS


Addition of linagliptin improves glucose control without an excess of hypoglycaemia in older patients with type 2 diabetes on stable insulin therapy.",2019,Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01).,"['older patients with type 2 diabetes on stable insulin therapy', 'older people with type 2 diabetes', 'Study population age and HbA1c (baseline mean\u2009±\u2009SD) were 72.4\u2009±\u20095.4 years and 8.2\u2009±\u20090.8%, respectively; ~80% of participants were aged ≥70\u2009years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate', 'older people with type 2 diabetes on stable insulin therapy', '24-week study recruited individuals on stable insulin, with baseline HbA1c 7.0%-10.0%, aged ≥60\u2009years and body mass index ≤45\u2009kg/m 2  ']","['linagliptin', 'placebo', 'Linagliptin', 'linagliptin 5 mg qd and placebo']","['severe hypoglycaemia', 'glycaemic control with a self-monitoring blood glucose device', 'glucose control', 'hypoglycaemia', 'Efficacy and safety', 'probability of achieving predefined HbA1c targets without hypoglycaemia', 'HbA1c and fasting plasma glucose', 'Adverse events (AEs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3811844'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",302.0,0.638143,Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01).,"[{'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Ledesma', 'Affiliation': 'Arlington Family Health Pavilion, PA, Arlington, Texas.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Morley', 'Affiliation': 'Division of Geriatric Medicine, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': ""Lewis-D'Agostino"", 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': 'Global BDS, Boehringer Ingelheim Pharma GmbH & Co, KG, Ingelheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'TA CardioMetabolism, Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van der Walt', 'Affiliation': 'International Project Management Cardiometabolic/CNS, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'TA CardioMetabolism, Boehringer Ingelheim International GmbH, Biberach, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13829']
932,31295205,The Efficacy of a Home Treatment Program Combined With Office-Based Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo-A Randomized Controlled Trial.,"OBJECTIVES


To compare the efficacy of the home treatment program combined with office-based canalith repositioning procedure (CRP) versus office-based CRP alone for benign paroxysmal positional vertigo (BPPV).
STUDY DESIGN


Randomized controlled trial.
METHOD


One hundred six patients with BPPV were randomly assigned to the home treatment program combined with office-based CRP group and the office-based CRP only group. The canalith repositioning procedure was performed in all patients at an out-patient clinic. The patients in the home treatment group were additionally instructed to do the exercise tailored for their affected canal at home every day. The presence of nystagmus was recorded. The symptom of vertigo and its impact on daily life were evaluated by the Dizziness Handicap Inventory (DHI) and a visual analog scale (VAS). All outcomes were evaluated at 1, 2, and 4 weeks after the initial treatment. A cure was defined as a patient having no nystagmus on the appointment date.
RESULTS


The success rate of the home treatment program combined with office-based CRP group and the office-based CRP only group were 100 and 91.67%, respectively (p = 0.043). The nystagmus duration, latency, DHI, and VAS scores decreased significantly from baseline at 1, 2, and 4 weeks for both groups (p < 0.001). No significant side effects were noted in either of the groups.
CONCLUSION


The office-based CRP plus home treatment program was more effective than the CRP only group for BPPV. Both groups were effective in reducing the symptom of vertigo and its impact on daily life.
TRIAL REGISTRATION


Clinicaltrials.in.th/TCTR20160810001.",2019,"The nystagmus duration, latency, DHI, and VAS scores decreased significantly from baseline at 1, 2, and 4 weeks for both groups (p < 0.001).","['Benign Paroxysmal Positional Vertigo', 'benign paroxysmal positional vertigo (BPPV', 'One hundred six patients with BPPV']","['home treatment program combined with office-based CRP group and the office-based CRP only group', 'Home Treatment Program Combined With Office-Based Canalith Repositioning Procedure', 'home treatment program combined with office-based canalith repositioning procedure (CRP) versus office-based CRP alone']","['symptom of vertigo and its impact on daily life', 'Dizziness Handicap Inventory (DHI) and a visual analog scale (VAS', 'success rate', 'nystagmus duration, latency, DHI, and VAS scores', 'side effects']","[{'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",106.0,0.0839287,"The nystagmus duration, latency, DHI, and VAS scores decreased significantly from baseline at 1, 2, and 4 weeks for both groups (p < 0.001).","[{'ForeName': 'Patorn', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nuntakarn', 'Initials': 'N', 'LastName': 'Eamudomkarn', 'Affiliation': ''}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Srirompotong', 'Affiliation': ''}, {'ForeName': 'Teeraporn', 'Initials': 'T', 'LastName': 'Ratanaanekchai', 'Affiliation': ''}, {'ForeName': 'Kwanchanok', 'Initials': 'K', 'LastName': 'Yimtae', 'Affiliation': ''}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002310']
933,31295199,Tinnitus Suppression Effect of Hearing Aids in Patients With High-frequency Hearing Loss: A Randomized Double-blind Controlled Trial.,"INTRODUCTION


Hearing aids (HAs) with frequency lowering have been used for high-frequency hearing loss (HFHL), but their effects on tinnitus relief have not been studied extensively. This randomized double-blind trial was performed to investigate and compare tinnitus suppression effects of conventional type HAs and frequency-lowering HAs in patients with HFHL.
METHODS


A total of 114 patients were randomized into three groups: conventional HA using wide dynamic range compression, HA with frequency translation, and HA with linear frequency transposition. Participants wore HAs for 3 months and then discontinued their use. The final evaluation was performed at 3 months after cessation of wearing HA (6 mo after the initial visit). The Tinnitus Handicap Inventory (THI) score and additional variables, such as matched tinnitus loudness and visual analog scale scores of subjectively perceived tinnitus loudness, daily awareness, and annoyance, were measured at the initial visit and at 3- and 6-month follow-ups.
RESULTS


THI score and most of the additional outcomes were significantly improved at 3 and 6 months (3 mo after HA removal) compared with their initial values in all three groups. The incidence rates of patients with improvements in the THI score by 20% or more were 71.0, 72.7, and 74.3% at 3 months, and 54.8, 51.6, and 59.4% at 6 months for the three groups, respectively. There were no significant differences in primary or additional variables between hearing aid types at either 3 or 6 months.
CONCLUSION


This is a consolidated standards of reporting trials-guided study providing direct evidence for tinnitus suppression effects of HA alone, without accompanying counseling or any other treatments, which lasted for at least 3 months after patients stopped using HAs. HAs effectively suppressed tinnitus in patients with HFHL regardless of the amplification strategy type.",2019,"RESULTS


THI score and most of the additional outcomes were significantly improved at 3 and 6 months (3 mo after HA removal) compared with their initial values in all three groups.","['114 patients', 'patients with HFHL', 'Patients With High-frequency Hearing Loss', 'patients with HFHL regardless of the amplification strategy type']","['Hearing Aids', 'conventional HA using wide dynamic range compression, HA with frequency translation, and HA with linear frequency transposition']","['THI score', 'Tinnitus Handicap Inventory (THI) score and additional variables, such as matched tinnitus loudness and visual analog scale scores of subjectively perceived tinnitus loudness, daily awareness, and annoyance']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018780', 'cui_str': 'Hearing Loss, High-Frequency'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0040759', 'cui_str': 'Transposition (morphologic abnormality)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",114.0,0.220169,"RESULTS


THI score and most of the additional outcomes were significantly improved at 3 and 6 months (3 mo after HA removal) compared with their initial values in all three groups.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Yakunina', 'Affiliation': 'Institute of Medical Science, Kangwon National University, School of Medicine.'}, {'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Kangwon National University Hospital.'}, {'ForeName': 'Yoon-Jong', 'Initials': 'YJ', 'LastName': 'Ryu', 'Affiliation': 'Department of Otolaryngology, Kangwon National University, School of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Nam', 'Affiliation': 'Department of Otolaryngology, Kangwon National University, School of Medicine, Chuncheon, Republic of Korea.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002315']
934,31300331,"Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial.","BACKGROUND


Results from a previous phase 3 study showed efficacy of the RTS,S/AS01 vaccine against severe and clinical malaria in children (in 11 sites in Africa) during a 3-4-year follow-up. We aimed to investigate malaria incidence up to 7 years postvaccination in three of the sites of the initial study.
METHODS


In the initial phase 3 study, infants aged 6-12 weeks and children aged 5-17 months were randomly assigned (1:1:1) to receive four RTS,S/AS01 doses (four-dose group), three RTS,S/AS01 doses and a comparator dose (three-dose group), or four comparator doses (control group). In this open-label extension study in Korogwe (Tanzania), Kombewa (Kenya), and Nanoro (Burkina Faso), we assessed severe malaria incidences as the primary outcome for 3 additional years (January, 2014, to December, 2016), up to 6 years (younger children) or 7 years (older children) postprimary vaccination in the modified intention-to-treat population (ie, participants who received at least one dose of the study vaccine). As secondary outcomes, we evaluated clinical malaria incidences and serious adverse events. This trial is registered with ClinicalTrials.gov, number NCT02207816.
FINDINGS


We enrolled 1739 older children (aged 5-7 years) and 1345 younger children (aged 3-5 years). During the 3-year extension, 66 severe malaria cases were reported, resulting in severe malaria incidence of 0·004 cases per person-years at risk (PPY; 95% CI 0-0·033) in the four-dose group, 0·007 PPY (0·001-0·052) in the three-dose group, and 0·009 PPY (0·001-0·066) in the control group in the older children category and a vaccine efficacy against severe malaria that did not contribute significantly to the overall efficacy (four-dose group 53·7% [95% CI -13·7 to 81·1], p=0·093; three-dose group 23·3% [-67·1 to 64·8], p=0·50). In younger children, severe malaria incidences were 0·007 PPY (0·001-0·058) in the four-dose group, 0·007 PPY (0·001-0·054) in the three-dose group, and 0·011 PPY (0·001-0·083) in the control group. Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27). Malaria transmission was still occurring as evidenced by an incidence of clinical malaria ranging from 0·165 PPY to 3·124 PPY across all study groups and sites. In older children, clinical malaria incidence was 1·079 PPY (95% CI 0·152-7·662) in the four-dose group, 1·108 PPY (0·156-7·868) in the three-dose group, and 1·016 PPY (0·14-7·213) in the control group. In younger children, malaria incidence was 1·632 PPY (0·23-11·59), 1·563 PPY (0·22-11·104), and 1·686 PPY (0·237-11·974), respectively. In the older age category in Nanoro, clinical malaria incidence was higher in the four-dose (2·444 PPY; p=0·011) and three-dose (2·411 PPY; p=0·034) groups compared with the control group (1·998 PPY). Three cerebral malaria episodes and five meningitis cases, but no vaccine-related severe adverse events, were reported.
INTERPRETATION


Overall, severe malaria incidence was low in all groups, with no evidence of rebound in RTS,S/AS01 recipients, despite an increased incidence of clinical malaria in older children who received RTS,S/AS01 compared with the comparator group in Nanoro. No safety signal was identified.
FUNDING


GlaxoSmithKline Biologicals SA.",2019,"Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27).","['3 additional years (January, 2014, to December, 2016), up to 6 years (younger children) or 7 years (older children) postprimary vaccination in the modified intention-to-treat population (ie, participants who received at least one dose of the study vaccine', '1739 older children (aged 5-7 years) and 1345 younger children (aged 3-5 years', 'infants aged 6-12 weeks and children aged 5-17 months', 'children and infants in Africa', 'children (in 11 sites in Africa']","['RTS,S/AS01 vaccination', 'RTS,S/AS01 vaccine']","['clinical malaria incidences and serious adverse events', 'clinical malaria incidence', 'cerebral malaria episodes', 'severe malaria incidence', 'severe malaria incidences', 'clinical malaria', 'vaccine efficacy against severe malaria', 'overall efficacy', 'malaria incidence']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1739.0,0.113118,"Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27).","[{'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Otieno', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Gesase', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Otieno', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Liheluka', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valéa', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': ""Sing'oei"", 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Anangisye', 'Initials': 'A', 'LastName': 'Malabeja', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Valia', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wangwe', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gvozdenovic', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Guerra Mendoza', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso. Electronic address: marc.lievens@gsk.com.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lusingu', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30300-7']
935,31297576,Micro-fragmented stromal-vascular fraction plus microfractures provides better clinical results than microfractures alone in symptomatic focal chondral lesions of the knee.,"PURPOSE


To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone.
METHODS


Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption.
RESULTS


All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
CONCLUSIONS


Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs.
LEVEL OF EVIDENCE


Level 1-therapeutic study.",2020,"At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
","['Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee', 'patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone']",[],"['WOMAC score', 'VAS scores', 'Analgesic and anti-inflammatory consumption', 'adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption', 'adverse reactions', 'WOMAC scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage (disorder)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0442012', 'cui_str': 'Chondral (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0553153,"At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bisicchia', 'Affiliation': 'Applied Biotechnologies and Translational Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy. s.bisicchia@gmail.com.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bernardi', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}, {'ForeName': 'Susanna M', 'Initials': 'SM', 'LastName': 'Pagnotta', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Tudisco', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05621-0']
936,31300951,Randomized clinical trial of an elastomeric sealant for hemostasis in thoracic aortic surgery.,"OBJECTIVES


This study aimed to demonstrate the efficacy and safety of a newly developed elastomeric sealant, which does not require any blood coagulation system to exert its effect, during thoracic aortic surgery.
METHODS


This is a multicenter, randomized study conducted in six hospitals in Japan. A total of 81 patients undergoing replacement surgery of a thoracic aortic aneurysm using cardiopulmonary bypass were randomized with a ratio of 2-:1 for those patients designated to receive the sealant (Group S, 54 patients) or those without the usage of the sealant (Group C, 27 patients). The primary endpoints were bleeding from each anastomosis at two time points: (1) immediately before applying protamine and (2) 15 min after applying protamine. The patients were followed for 6 months.
RESULTS


The number of anastomoses checked for bleeding was 196 in Group S and 117 in Group C. Before protamine sulfate administration, complete hemostasis was obtained in 155 anastomoses (79%) in Group S compared to 45 anastomoses (38%) in Group C (p < 0.001). Fifteen minutes after the administration of protamine sulfate infusion, bleeding stopped completely in 173 anastomoses (88%) in Group S and in 71 anastomoses (61%, p < 0.001) in Group C. Between the two groups, there were no marked differences in the patient background or in the incidence of major adverse events.
CONCLUSIONS


The sealant is effective in achieving hemostasis, even under fully heparinized conditions. The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.",2020,"The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.","['81 patients undergoing replacement surgery of a thoracic aortic aneurysm using cardiopulmonary bypass', 'six hospitals in Japan', 'thoracic aortic surgery']","['protamine sulfate', 'elastomeric sealant']","['incidence of major adverse events', 'bleeding from each anastomosis', 'number of anastomoses checked for bleeding', 'complete hemostasis', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0162872', 'cui_str': 'Aortic Aneurysm, Thoracic'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}]","[{'cui': 'C0033602', 'cui_str': 'Protamine Sulfate (USP)'}, {'cui': 'C0444925', 'cui_str': 'elastomeric'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.106148,"The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.","[{'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, 1-8-1 Jigyohama, Fukuoka, 810-8563, Japan. morita.shigeki.mu@mail.hosp.go.jp.'}, {'ForeName': 'Takehisa', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of Biomedical Engineering, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Tashiro', 'Affiliation': 'Department of Cardiovascular Surgery, University of Fukuoka Medical School, Fukuoka, Japan.'}, {'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Komiya', 'Affiliation': 'Department of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ogino', 'Affiliation': 'Department of Cardiovascular Surgery, National Cardiovascular and Research Center, Suita, Osaka, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Mukohara', 'Affiliation': 'Department of Cardiovascular Surgery, Hyogo Brain and Heart Center, Himeji, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Tominaga', 'Affiliation': 'Division of Cardiovascular Surgery, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-019-01169-5']
937,31298357,Proteomic evaluation of GCF in the development of pregnancy related periodontal disease: a pilot clinical study.,"OBJECTIVE


This pilot study analyzed the possible changes of periodontal disease status in female patients during the period following pregnancy. Both clinical and laboratory data were collected and analyzed.
PATIENTS AND METHODS


A non-randomized controlled clinical trial was conducted by the Periodontal Department of the Dental Clinic in collaboration with the Pediatrics Department, at Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. Ten female patients, who completed the pregnancy without complications, were enrolled in this research protocol forming the experimental group. During the first post-partum days, gingival crevicular fluid (GCF) samples were collected and analyzed with high-performance liquid chromatography associated with high-resolution mass spectrometry (HPLC ESI MS); periodontal parameters as pocket depth (PD), full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) were recorded, and a professional oral hygiene session was performed. The same protocol was applied after three months with the same patients forming the recall group. A control group was created in order to compare the results with GCF samples from 10 not pregnant fertile women.
RESULTS


Student's t-test has been used to evaluate the statistical significance of the collected data. Mean levels of PD decreased from 3.75 mm ± 1.2 mm after pregnancy to 2.88 mm ± 0.85 mm at three months post-partum (p<0.01). Mean value of FMPS and FMBS decreased from 21.8% ± 1.35% and 34.27% ± 1.5% after pregnancy to 13% ± 2.81% and 17.55% ± 2.84% at three months post-partum, respectively (p<0.05). The concentration of each analyzed peptide has changed in relation to the general improvement of the periodontal status at three months post-partum.
CONCLUSIONS


Pregnancy may be associated with an increased risk of periodontal disease. Both clinical and laboratory data have demonstrated that a professional oral hygiene session can affect the course of pregnancy inducing periodontal diseases allowing a faster healing and restitutio ab integrum.",2019,"Mean value of FMPS and FMBS decreased from 21.8% ± 1.35% and 34.27% ± 1.5% after pregnancy to 13% ± 2.81% and 17.55% ± 2.84% at three months post-partum, respectively (p<0.05).","['pregnancy related periodontal disease', '10 not pregnant fertile women', 'Ten female patients, who completed the pregnancy without complications', 'Periodontal Department of the Dental Clinic in collaboration with the Pediatrics Department, at Fondazione Policlinico Universitario A. Gemelli, Rome, Italy', 'female patients during the period following pregnancy']",['GCF'],"['risk of periodontal disease', 'Mean value of FMPS and FMBS', 'Mean levels of PD', 'high-resolution mass spectrometry (HPLC ESI MS); periodontal parameters as pocket depth (PD), full mouth plaque score (FMPS) and full mouth bleeding score (FMBS']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011344', 'cui_str': 'Dental Clinics'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0653397', 'cui_str': '2-(4-fluorophenyl)-N-methylsuccinimide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0037813', 'cui_str': 'Spectrum Analysis, Mass'}, {'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}]",10.0,0.036825,"Mean value of FMPS and FMBS decreased from 21.8% ± 1.35% and 34.27% ± 1.5% after pregnancy to 13% ± 2.81% and 17.55% ± 2.84% at three months post-partum, respectively (p<0.05).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dassatti', 'Affiliation': 'Institute of Dentistry and Maxillofacial Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. nico.stefanelli18@gmail.com.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Manicone', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Iavarone', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stefanelli', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nicoletti', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lazzareschi', 'Affiliation': ''}, {'ForeName': 'R P M', 'Initials': 'RPM', 'LastName': 'Luciano', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castagnola', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Addona"", 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201906_18166']
938,31287736,Telemedicine-Assisted Self-Management Program for Type 2 Diabetes Patients.,"Background:  Lifestyle interventions with personalized self-management programs have shown benefits for patients with type 2 diabetes mellitus (T2DM), a devastating highly prevalent disease worldwide. Despite advances in drug therapy and nonpharmacological strategies achieved in the past recent years, self-management programs to be implemented in everyday life are needed. The aim of the present prospective study was to evaluate the effects, in terms of glycated hemoglobin (HbA 1c ) values and self-management behavior, of a telemedicine-assisted self-management program offered to T2DM patients by a large private health insurance company.  Methods:  Participants with T2DM included 60 adults in the intervention group ( M  = 59.4 years) and 55 adults in the control group ( M  = 58.4 years). In the beginning of the study, the intervention group was provided with a tablet computer, a glucometer, and a step counter. Additionally, they received an individual need-based telephone coaching to address and improve motivation and diabetes self-management in daily life. The control group received care as usual and were not offered additional treatment. The study examined the results of a diabetes lifestyle program after 3 months.  Results:  The intervention resulted in significantly greater declines in HbA 1c  compared with the control group. In addition, tele-assisted participants showed significant improvements in Diabetes Self-Management scale score and body mass index compared with usual care participants.  Conclusions:  Patients with T2DM can benefit from telemedicine-assisted self-management programs, which may offer new options for treatment and prevention of disease progression. More follow-up and research is needed to assess feasibility and effectiveness on a larger scale.",2019,The intervention resulted in significantly greater declines in HbA 1c  compared with the control group.,"['patients with type 2 diabetes mellitus (T2DM', 'included 60 adults in the intervention group ( M \u2009=\u200959.4 years) and 55 adults in the control group ( M \u2009=\u200958.4 years', 'T2DM patients by a large private health insurance company', 'Participants with T2DM', 'Type 2 Diabetes Patients']","['individual need-based telephone coaching to address and improve motivation and diabetes self-management in daily life', 'Telemedicine-Assisted Self-Management Program', 'personalized self-management programs', 'telemedicine-assisted self-management program']","['glycated hemoglobin (HbA 1c ) values and self-management behavior', 'Diabetes Self-Management scale score and body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",60.0,0.0221459,The intervention resulted in significantly greater declines in HbA 1c  compared with the control group.,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'von Storch', 'Affiliation': 'GROW Gerontological Research on Well-Being, Faculty of Medicine and Faculty of Human Sciences, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Graaf', 'Affiliation': 'Health Care Managment, Central Krankenversicherung AG, Cologne, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Wunderlich', 'Affiliation': 'Generali Health Solutions GmbH, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rietz', 'Affiliation': 'Department of Educational Science, Mixed Methods-Research, PH Heidelberg, University of Education, Heidelberg, Germany.'}, {'ForeName': 'M Cristina', 'Initials': 'MC', 'LastName': 'Polidori', 'Affiliation': 'Faculty of Medicine, Aging Clinical Research, Department Medicine II of Internal Medicine and Center for Molecular Medicine Cologne, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Woopen', 'Affiliation': 'Faculty of Medicine, Research Unit Ethics, University Hospital Cologne, Cologne, Germany.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0056']
939,30753662,Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial.,"Smokers are at high risk of oral disease and report sub-optimal oral hygiene. Improving smokers' oral hygiene could reduce their future disease risk. The purpose of this study is to assess the effects of a novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L) targeted to socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines. Smokers (n = 718) were randomized to standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention and were advised of the benefits of routine oral hygiene, encouraged to brush and floss daily (for better oral health and to manage cigarette cravings), and provided a toothbrush and floss. Participants were followed for 6 months to assess the intervention effects on routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy. Data were collected between 2015 and 2017. At 2-month follow-up, OH4L participants were more likely to meet the American Dental Association (ADA) recommendations for brushing twice daily (adjusted RR = 1.15 [1.04, 1.27], p = .006), flossing daily (adjusted RR = 1.20 [1.03, 1.39], p = .02), and for both brushing and flossing (adjusted RR = 1.33 [1.10, 1.61], p = .003). Daily flossing was more likely at 6-month follow-up (adjusted RR = 1.21 [1.04, 1.42], p = .02) among OH4L participants. The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months. Integrating oral hygiene promotion with standard tobacco quitline services improved oral health self-care.",2020,The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months.,"['socioeconomically disadvantaged smokers', 'Smokers (n = 718', 'socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines']","['novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L', 'standard tobacco quitline services', 'novel oral health promotion program', 'standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention']","['oral health self-care', 'routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy', 'self-efficacy and motivation for daily flossing', 'American Dental Association (ADA) recommendations', 'routine oral hygiene']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0029162'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0029162'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002456', 'cui_str': 'American Dental Association'}]",718.0,0.0379281,The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months.,"[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Krakauer', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Blasi', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Bush', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Eden Prairie, MN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz009']
940,31286275,Management of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): an Evolving Treatment Paradigm.,"OPINION STATEMENT


Combination systemic therapy is now standard of care for all men with metastatic, hormone-sensitive prostate cancer (mHSPC). Patients with mHSPC should be treated with standard androgen deprivation therapy (ADT) and abiraterone acetate with prednisone or docetaxel (chemohormoanl therapy) unless there are contraindications to combination therapy. Based on the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) study subgroup analysis, chemohormonal therapy may be most beneficial in men with high-volume disease burden, as men with low-volume metastatic disease do not appear to experience a survival benefit with chemohormonal therapy, while abiraterone in combination with ADT appears to be beneficial across both disease volume subgroups. Decisions regarding whether to use chemohormonal therapy or abiraterone and ADT for men with mHSPC should integrate consideration of volume of disease burden, quality of life effects, duration of therapy, and patient preferences for treatment as there is no formally powered prospective head-to-head comparison of these options demonstrating superiority of one approach over the other. Treatment of the primary tumor with radiation should be considered in men with de novo low-volume metastatic disease as radiation is associated with prolonged survival and a tolerable toxicity profile. Men with de novo high-volume metastatic disease do not appear to have improved survival with radiation of the primary tumor. Numerous clinical trials are ongoing to evaluate treatment approaches that may benefit men with mHSPC. Radical prostatectomy in men with mHSPC in combination with optimal systemic therapy is currently being assessed in a clinical trial, but should not be considered outside of a clinical trial. Metastasis-directed therapy with radiotherapy directed at metastatic lesions is still investigational, but can be considered in clinical trials in men with oligometastatic disease. Multiple studies are enrolling worldwide for men with mHSPC, and these should be considered for all interested patients.",2019,Based on the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer,"['Prostate Cancer', 'men with high-volume disease burden, as men with low-volume metastatic disease', 'men with oligometastatic disease', 'Patients with mHSPC', 'men with mHSPC', 'Men with de novo high-volume metastatic disease', 'men with metastatic, hormone-sensitive prostate cancer (mHSPC', 'Metastatic Hormone-Sensitive Prostate Cancer (mHSPC']","['Radical prostatectomy', 'chemohormonal therapy or abiraterone and ADT', 'radiotherapy', 'standard androgen deprivation therapy (ADT) and abiraterone acetate with prednisone or docetaxel (chemohormoanl therapy']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]",[],,0.0579742,Based on the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer,"[{'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Weiner', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Oluwarotimi S', 'Initials': 'OS', 'LastName': 'Nettey', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Morgans', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, 676 N. St. Clair, Suite 850, Chicago, IL, 60611, USA. alicia.morgans@northwestern.edu.'}]",Current treatment options in oncology,['10.1007/s11864-019-0668-8']
941,31241003,The Effect of Framed Health Messages on Intention to Take Antivirals for Pandemic Influenza: A Vignette-Based Randomised Controlled Trial.,"During the last influenza pandemic, adherence to antivirals was suboptimal. This study investigated the effect of manipulating the wording of written health messages on intentions to use antivirals as prophylaxis for pandemic influenza. After reading a hypothetical pandemic flu scenario, adult UK residents (N = 216) were randomly allocated to one of the four conditions, defined by a 2 × 2 (agency assignment × attribute framing) factorial design. Each condition presented messages describing the pandemic flu using linguistic expressions that assigned agency to either humans (HA: human agency) or the virus itself (VA: virus agency), whilst describing the antivirals side effects in terms of the chances of either experiencing (NF: negative framing) or not experiencing side effects (PF: positive framing). Intentions to use the antivirals and potential mediating factors were measured. Mean adherence intentions were high in all conditions with no significant differences between them. Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions. The VA messages increased perceived severity, the PF messages increased self-efficacy, whilst VA*PF affected response efficacy. The evidence did not support the hypothesis that the VA and PF framings can increase adherence intentions compared to the HA and NF messages, respectively.",2019,"Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions.",['adult UK residents (N = 216'],['Framed Health Messages'],"['self-efficacy, whilst VA*PF affected response efficacy', 'adherence intentions', 'Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs', 'Mean adherence intentions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",216.0,0.0498844,"Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions.","[{'ForeName': 'Donatella', 'Initials': 'D', 'LastName': ""D'Antoni"", 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Auyeung', 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}]",Journal of health communication,['10.1080/10810730.2019.1631914']
942,27279672,Sharp sensitivity bounds for mediation under unmeasured mediator-outcome confounding.,"It is often of interest to decompose the total effect of an exposure into a component that acts on the outcome through some mediator and a component that acts independently through other pathways. Said another way, we are interested in the direct and indirect effects of the exposure on the outcome. Even if the exposure is randomly assigned, it is often infeasible to randomize the mediator, leaving the mediator-outcome confounding not fully controlled. We develop a sensitivity analysis technique that can bound the direct and indirect effects without parametric assumptions about the unmeasured mediator-outcome confounding.",2016,"Even if the exposure is randomly assigned, it is often infeasible to randomize the mediator, leaving the mediator-outcome confounding not fully controlled.",[],[],[],[],[],[],,0.0232345,"Even if the exposure is randomly assigned, it is often infeasible to randomize the mediator, leaving the mediator-outcome confounding not fully controlled.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ding', 'Affiliation': 'Department of Statistics, University of California, Berkeley, California 94720, U.S.A.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Vanderweele', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts 02115, U.S.A. , tvanderw@hsph.harvard.edu.'}]",Biometrika,[]
943,31280470,Effect of 9 months of vitamin D supplementation on arterial stiffness and blood pressure in Graves' disease: a randomized clinical trial.,"PURPOSE


Risk of cardiovascular disease (CVD) is increased in Graves' disease (GD). CVD is predicted by increased pulse wave velocity (PWV) and blood pressure (BP). GD and these risk factors are all associated with lower levels of vitamin D. We aimed to assess the effect of supplemental vitamin D on PWV and BP in GD.
METHODS


In a double-blinded trial, newly diagnosed GD patients were randomized to vitamin D3 70 µg/day (n = 44) or placebo (n = 42) as add-on to anti-thyroid medication. At baseline, 3 and 9 months PWV, BP and wave analysis were performed in office and 24 h setting. Between-group differences in change at 9 months were analyzed using linear mixed modelling. In subanalysis, effect of intervention in regard to baseline vitamin D insufficiency (25(OH)D < 50 nmol/L) was investigated. (The DAGMAR study, clinicaltrials.gov ID NCT02384668).
RESULTS


PWV was unaffected by intervention in main analysis. However in the subanalysis, comparing the response to intervention in the vitamin D insufficient (n = 28) and the vitamin D replete patients, supplemental vitamin D induced a significant decrease in office PWV of 1.2 (95% CI: -2.3; -0.1) m/s compared to placebo. Of notice, baseline PWV was non-significantly higher among the vitamin D insufficient as compared to the replete participants. In response to vitamin D, office central systolic BP (-3.9 (95% CI: -7.5; -0.3) and brachial mean BP (-3.3 (95% CI: -6.5; -0.3) declined whereas 24 h measurements were unaffected.
CONCLUSIONS


High-dose vitamin D supplementation did not affect PWV. We observed significant reduction in office but not 24 h BP. Subanalysis showed a clinically relevant PWV reduction among vitamin D insufficient participants, although regression towards the mean might contribute to findings. Further studies on supplemental vitamin D in GD should focus on patients with vitamin D insufficiency.",2019,"Of notice, baseline PWV was non-significantly higher among the vitamin D insufficient as compared to the replete participants.","[""Graves' disease"", ""Graves' disease (GD"", 'newly diagnosed GD patients', 'patients with vitamin D insufficiency']","['supplemental vitamin D', 'vitamin D supplementation', 'placebo', 'vitamin D3']","['arterial stiffness and blood pressure', 'PWV', 'brachial mean BP', 'pulse wave velocity (PWV) and blood pressure (BP', 'office PWV', 'office central systolic BP', 'clinically relevant PWV reduction']","[{'cui': 'C0018213', 'cui_str': 'Graves Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.606681,"Of notice, baseline PWV was non-significantly higher among the vitamin D insufficient as compared to the replete participants.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Grove-Laugesen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus N, Denmark. dianagrove@clin.au.dk.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Malmstroem', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ebbehoj', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Anne Lene', 'Initials': 'AL', 'LastName': 'Riis', 'Affiliation': 'Medical Department, Regional Hospital Horsens, Sundvej 30, 8700, Horsens, Denmark.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Internal Medicine, Gentofte and Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.'}, {'ForeName': 'Klavs Würgler', 'Initials': 'KW', 'LastName': 'Hansen', 'Affiliation': 'Medical Department, Silkeborg Regional Hospital, Falkevej 3, 8600, Silkeborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus N, Denmark.'}]",Endocrine,['10.1007/s12020-019-01997-8']
944,31286397,The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery.,"BACKGROUND


Dexmedetomidine is an α 2  receptor agonist with sedative and analgesic properties. During bariatric surgery, its use may reduce postoperative opioid requirements, reduce their side effects, and improve quality of recovery. The aim of this prospective randomized controlled trial was to compare the effect of dexmedetomidine bolus and infusion versus morphine bolus given prior to the end of laparoscopic bariatric surgery.
METHODS


Sixty morbidly obese patients (BMI > 40 kg m -2 ) aged 18 to 60 years, undergoing laparoscopic sleeve gastrectomy, received morphine sulfate (bolus 0.08 mg kg -1  followed by a saline infusion) (group M, n = 30) or dexmedetomidine (loading dose of 1 μg kg -1  followed by 0.5 μg kg -1  h -1 ) (group D, n = 30) 30 min before the end of surgery. Data collected included morphine consumption in the post-anesthesia care unit (PACU) (primary outcome) and at 24 h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery.
RESULTS


There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01). Group D patients had more cardiovascular stability.
CONCLUSIONS


Dexmedetomidine given prior to end of laparoscopic sleeve gastrectomy provides the same level of postoperative analgesia as morphine with better hemodynamic profile.",2019,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","['aged 18 to 60\xa0years, undergoing', 'Sixty morbidly obese patients (BMI\u2009>\u200940\xa0kg']","['Laparoscopic Bariatric Surgery', 'Dexmedetomidine', 'morphine sulfate (bolus 0.08', 'dexmedetomidine (loading dose of 1\xa0μg\xa0kg -1  followed by 0.5\xa0μg', 'PACU', 'laparoscopic sleeve gastrectomy', 'Intraoperative Dexmedetomidine Versus Morphine', 'dexmedetomidine bolus and infusion versus morphine']","['Postoperative Morphine Requirements', 'morphine consumption', '24\xa0h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery', 'cardiovascular stability']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",60.0,0.402263,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","[{'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Zeeni', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Aouad', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Keserwan Medical Center, Keserwan, Jounieh, Lebanon.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Naji', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Jabbour-Khoury', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ramzi S', 'Initials': 'RS', 'LastName': 'Alami', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Bassem Y', 'Initials': 'BY', 'LastName': 'Safadi', 'Affiliation': 'Department of Surgery, Lebanese American University, Beirut, Lebanon.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Siddik-Sayyid', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon. ss01@aub.edu.lb.'}]",Obesity surgery,['10.1007/s11695-019-04074-1']
945,31282006,Longer-term liraglutide administration at the highest dose approved for obesity increases reward-related orbitofrontal cortex activation in response to food cues: Implications for plateauing weight loss in response to anti-obesity therapies.,"AIMS


GLP-1 analogs have recently risen to the forefront as effective medications for lowering weight through actions in the central nervous system (CNS). However, their actions in the CNS have not yet been studied in the human brain after longer-term administration at the highest dose approved for obesity (liraglutide 3.0 mg).
MATERIALS AND METHODS


A total of 20 participants with obesity were treated with placebo and liraglutide (3.0 mg) in the context of a randomized, placebo-controlled, double-blind, cross-over trial after 5 weeks of dose escalation. Neurocognitive and neuroimaging (fMRI) responses to food cues were examined at the clinical research center of Beth Israel Deaconess Medical Center.
RESULTS


While using liraglutide, patients lost more weight (placebo-subtracted -2.7%; P < .001), had decreased fasting glucose (P < .001) and showed improved cholesterol levels. In an uncontrolled analysis, brain activation in response to food images was not altered by liraglutide vs placebo. When controlled for BMI/weight, liraglutide increased activation of the right orbitofrontal cortex (OFC) in response to food cues (P < .016, corrected for multiple comparisons).
CONCLUSIONS


In contrast to prior studies, we demonstrate for the first time that liraglutide treatment, administered over a longer period at the highest doses approved for obesity, does not alter brain activation in response to food cues. A counter-regulatory increase in reward-related OFC activation in response to food cues can be observed when neuroimaging data are controlled for BMI changes, indicating changes in CNS that could lead to later plateaus of weight loss. These data point to a promising focus for additional interventions which, by contributing to the CNS reward system, could provide tangible benefits in reversing the plateauing phenomenon and promoting further weight loss.",2019,"In an uncontrolled analysis, brain activations to food images were not altered in response to liraglutide vs. placebo.",['20 subjects with obesity were treated with'],"['liraglutide vs. placebo', 'placebo and liraglutide', 'placebo', 'liraglutide']","['Neurocognitive and neuroimaging (fMRI) responses', 'cholesterol levels', 'fasting glucose']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",20.0,0.0497411,"In an uncontrolled analysis, brain activations to food images were not altered in response to liraglutide vs. placebo.","[{'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jagriti', 'Initials': 'J', 'LastName': 'Upadhyay', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Rutagengwa', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'DiPrisco', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Ranta', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Adra', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Bapatla', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vivian P', 'Initials': 'VP', 'LastName': 'Douglas', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Konstantinos A A', 'Initials': 'KAA', 'LastName': 'Douglas', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nolen-Doerr', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mathew', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13827']
946,31801155,"Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.","BACKGROUND


Displaying heart rate characteristic (HRC) scores was associated with lower sepsis-associated mortality in very low birth weight (VLBW) infants in a multicenter randomized controlled trial (HeRO trial). The aim of this study was to test whether HRC indices rise before diagnosis of urinary tract infection (UTI) or meningitis, with and without concomitant BSI.
METHODS


Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants. The HRC index was analyzed 12 h prior to positive cultures compared to 36 h prior, using paired signed-rank tests.
RESULTS


UTI, meningitis, and BSI were diagnosed in 10%, 2%, and 24% of infants, respectively. The mean hourly HRC index was significantly higher 12 h prior to diagnosis of UTI and BSI compared to 36 h prior (UTI 2.07 versus 1.81; BSI 2.62 versus 2.25, both p < 0.0001). The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
CONCLUSIONS


In a large cohort of VLBW infants enrolled in the HeRO trial, the HRC index increased in the 24-h period prior to diagnosis of UTI and BSI but not meningitis.",2020,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","['Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants', 'very low birth weight infants enrolled in a heart rate characteristic monitoring trial']",[],"['HRC index', 'baseline HRC index', 'Meningitis, urinary tract, and bloodstream infections', 'mean hourly HRC index', 'UTI, meningitis, and BSI']","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0042027'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.151055,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","[{'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. hendrik.weitkamp@vumc.org.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Aschner', 'Affiliation': 'Pediatrics, Hackensack Meridian Health School of Medicine, Nutley, NJ, USA.'}, {'ForeName': 'Wallly A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bancalari', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Perez', 'Affiliation': 'Pediatrix Medical Group, Orlando, FL, USA.'}, {'ForeName': 'Cristina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whit Walker', 'Affiliation': 'USC School of Medicine, Greenville Memorial Hospital, Greenville, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Porcelli', 'Affiliation': 'Pediatrics, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Pediatrics, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grossarth', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}]",Pediatric research,['10.1038/s41390-019-0701-4']
947,30617130,Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma.,"PURPOSE


To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA).
PATIENTS AND METHODS


ECHELON-1 is a global, open-label, randomized phase III study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin) as first-line therapy in subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles.
RESULTS


The NA subgroup consisted of 497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint [modified progression-free survival (PFS) per independent review] demonstrated an improvement among subjects who received A+AVD compared with ABVD (HR = 0.60;  P  = 0.012). For PFS, the risk of progression or death was also reduced (HR = 0.50;  P  = 0.002). Subsequent anticancer therapies were lower in the A+AVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with A+AVD versus ABVD.
CONCLUSIONS


The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support A+AVD as a frontline treatment option for patients with stage III or IV cHL.",2019,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","['North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma', '497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms', 'patients with stage III or IV cHL', 'subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490', 'subjects on the ECHELON-1 study treated in North America (NA']","['Brentuximab Vedotin plus Chemotherapy', 'A+AVD or ABVD', 'doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin']","['progression-free survival (PFS', 'febrile neutropenia', 'efficacy benefit and manageable toxicity profile', 'pulmonary toxicity', 'peripheral neuropathy', 'Grade 3 or 4 adverse events (AEs', 'safety and efficacy outcomes', 'risk of progression or death']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",497.0,0.110861,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","[{'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Hematology/Oncology, Barbara Ann Karmanos Cancer Center, Detroit, Michigan. RRamchandren@utmck.edu.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Centre, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Leo I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuruvilla', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Engley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Manley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2435']
948,31250938,Professionals' experiences with palliative care and collaboration in relation to a randomised clinical trial: a qualitative interview study.,"BACKGROUND


International evidence on the outcome of generalist versus specialist palliative care provision in palliative care trajectories is limited and varied. In general, intervention studies can influence the organisation of palliative care practice and professional collaborations. However, randomised clinical trials in palliative care rarely consider the organisational significance of the studies, as experienced by the professionals involved. DOMUS is the abbreviation for a Danish intervention study designed as a randomised clinical trial, investigating an accelerated transition from oncological to specialist palliative care at home for patients with incurable cancer. Alongside conducting the palliative care intervention study, we wanted to discover the perspectives of the healthcare professionals involved.
AIM


To explore the organisational significance of the DOMUS intervention study as experienced by the professionals involved.
DESIGN


A qualitative interview study, using thematic content analysis and inspired by organisational theory.
SETTING/PARTICIPANTS


Thirty-eight professionals from four units involved in the DOMUS intervention study took part in 10 groups and six individual interviews.
RESULTS


The DOMUS randomised clinical trial intervention influenced and sometimes disrupted both the ways of organising, collaborating and practising palliative care, and patients' and relatives' understanding of their own situation. It did this by (1) referring a broader palliative care target group to specialist palliative care, leading to (2) different palliative care needs, professional tasks, and perceived impact on (3) the organisation of palliative care and (4) professional collaboration.
CONCLUSION


Professionals involved in the DOMUS palliative care intervention found that the study had organisational significance, with an influence on professionals, patients and relatives. Specialist palliative care in Denmark is devoted organisationally and professionally to patients with severe or complex palliative care needs. Hence, new ways of organising palliative care for people in the earlier stages of their disease are needed.",2020,"The DOMUS randomised clinical trial intervention influenced and sometimes disrupted both the ways of organising, collaborating and practising palliative care, and patients' and relatives' understanding of their own situation.","['patients with severe or complex palliative care needs', 'Thirty-eight professionals from four units involved in the DOMUS intervention study took part in 10 groups and six individual interviews', 'patients with incurable cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],[],38.0,0.0870136,"The DOMUS randomised clinical trial intervention influenced and sometimes disrupted both the ways of organising, collaborating and practising palliative care, and patients' and relatives' understanding of their own situation.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Raunkiaer', 'Affiliation': 'REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Martin Sandberg', 'Initials': 'MS', 'LastName': 'Buch', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Holm-Petersen', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Timm', 'Affiliation': 'REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12729']
949,31537701,The pharmacogenomics of inhaled corticosteroids and lung function decline in COPD.,"Inhaled corticosteroids (ICS) are widely prescribed for patients with chronic obstructive pulmonary disease (COPD), yet have variable outcomes and adverse reactions, which may be genetically determined. The primary aim of the study was to identify the genetic determinants for forced expiratory volume in 1 s (FEV 1 ) changes related to ICS therapy.In the Lung Health Study (LHS)-2, 1116 COPD patients were randomised to the ICS triamcinolone acetonide (n=559) or placebo (n=557) with spirometry performed every 6 months for 3 years. We performed a pharmacogenomic genome-wide association study for the genotype-by-ICS treatment effect on 3 years of FEV 1  changes (estimated as slope) in 802 genotyped LHS-2 participants. Replication was performed in 199 COPD patients randomised to the ICS, fluticasone or placebo.A total of five loci showed genotype-by-ICS interaction at p<5×10 -6 ; of these, single nucleotide polymorphism (SNP) rs111720447 on chromosome 7 was replicated (discovery p=4.8×10 -6 , replication p=5.9×10 -5 ) with the same direction of interaction effect. ENCODE (Encyclopedia of DNA Elements) data revealed that in glucocorticoid-treated (dexamethasone) A549 alveolar cell line, glucocorticoid receptor binding sites were located near SNP rs111720447. In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele β 56.36 mL·year -1 , 95% CI 29.96-82.76 mL·year -1 ) and in patients who were assigned to placebo, although the relationship was weaker and in the opposite direction to that in the ICS group (C allele β -27.57 mL·year -1 , 95% CI -53.27- -1.87 mL·year -1 ).The study uncovered genetic factors associated with FEV 1  changes related to ICS in COPD patients, which may provide new insight on the potential biology of steroid responsiveness in COPD.",2019,"In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele beta=56.35 mL·year -1 , 95% confidence interval (CI)=29.96, 82.76 mL·yr -1 ) and also in patients who were assigned to placebo, though the relationship was weaker and in the opposite direction than that in the ICS group (C allele beta=-27.57 mL·year","['199 COPD patients randomised to the', '802 genotyped LHS-2 participants', 'COPD', 'COPD patients', 'patients with chronic obstructive pulmonary disease (COPD', '1116 COPD patients']","['Inhaled corticosteroids (ICS', 'ICS, triamcinolone acetonide', 'glucocorticoid treated (dexamethasone', 'placebo', 'ICS, fluticasone or placebo']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]",[],1116.0,0.231731,"In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele beta=56.35 mL·year -1 , 95% confidence interval (CI)=29.96, 82.76 mL·yr -1 ) and also in patients who were assigned to placebo, though the relationship was weaker and in the opposite direction than that in the ICS group (C allele beta=-27.57 mL·year","[{'ForeName': ""Ma'en"", 'Initials': 'M', 'LastName': 'Obeidat', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': 'Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Joubert', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, QC, Canada.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hao', 'Affiliation': 'Dept of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Rafaels', 'Affiliation': 'Division of Biomedical Informatics and Personalized Medicine, Dept of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Rasika', 'Initials': 'R', 'LastName': 'Mathias', 'Affiliation': 'Division of Genetic Epidemiology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Ruczinski', 'Affiliation': 'Dept of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Terri H', 'Initials': 'TH', 'LastName': 'Beaty', 'Affiliation': 'Dept of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen C', 'Initials': 'KC', 'LastName': 'Barnes', 'Affiliation': 'Division of Biomedical Informatics and Personalized Medicine, Dept of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'S F Paul', 'Initials': 'SFP', 'LastName': 'Man', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Paré', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}]",The European respiratory journal,['10.1183/13993003.00521-2019']
950,31250182,An allied health rehabilitation program for patients following surgery for abdomino-pelvic cancer: a feasibility and pilot clinical study.,"PURPOSE


To investigate the feasibility of conducting a rehabilitation program for patients following surgery for abdomino-pelvic cancer.
METHODS


A non-randomised controlled before-and-after study. Patients who had undergone surgery for stage I-III abdomino-pelvic cancer (colorectal, gynaecological or prostate cancer) were recruited. The rehabilitation group (n = 84) received an 8-week, bi-weekly education and exercise program conducted by a physiotherapist, exercise physiologist, health psychologist and dietician, supplemented by exercise diaries and telephone coaching sessions. The comparator group (n = 104) completed postal questionnaires only. Feasibility measures, functional exercise capacity, muscle strength, physical activity levels, pelvic floor symptoms, anxiety and depression, health-related quality of life (HRQoL) and self-efficacy were measured at baseline (time 1), immediately post-intervention (time 2) and at 6 months post-baseline (time 3) and compared within- and between-groups.
RESULTS


The consent rate to the rehabilitation program was 24%. Eighty-one percent of the rehabilitation group attended 85-100% of 16 scheduled sessions. Overall satisfaction with the program was 96%. Functional exercise capacity, handgrip strength in males, bowel symptoms, physical activity levels, depression and HRQoL were significantly improved in the rehabilitation group (p < 0.05) at time 2. The improvements in all these outcomes were sustained at time 3. The rehabilitation group had significantly improved physical activity levels, depression and HRQoL compared with the comparator group at times 2 and 3 (p < 0.05).
CONCLUSION


Recruitment to this oncology rehabilitation program was more difficult than expected; however, attendance and patient satisfaction were high. This program had positive effects on several important clinical outcomes in patients following abdomino-pelvic cancer treatment.
TRIAL REGISTRATION


ANZCTR 12614000580673.",2020,"The rehabilitation group had significantly improved physical activity levels, depression and HRQoL compared with the comparator group at times 2 and 3 (p < 0.05).
","['patients following surgery for abdomino-pelvic cancer', 'Eighty-one percent of the rehabilitation group attended 85-100% of 16 scheduled sessions', 'Patients who had undergone surgery for stage I-III abdomino-pelvic cancer (colorectal, gynaecological or prostate cancer', 'patients following abdomino-pelvic cancer treatment']","['allied health rehabilitation program', 'bi-weekly education and exercise program conducted by a physiotherapist, exercise physiologist, health psychologist and dietician, supplemented by exercise diaries and telephone coaching sessions', 'rehabilitation program']","['Feasibility measures, functional exercise capacity, muscle strength, physical activity levels, pelvic floor symptoms, anxiety and depression, health-related quality of life (HRQoL) and self-efficacy', 'Overall satisfaction', 'attendance and patient satisfaction', 'physical activity levels, depression and HRQoL', 'Functional exercise capacity, handgrip strength in males, bowel symptoms, physical activity levels, depression and HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0751416', 'cui_str': 'Cancer of Pelvis'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C1555909', 'cui_str': 'Health psychologist (occupation)'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}]",,0.034658,"The rehabilitation group had significantly improved physical activity levels, depression and HRQoL compared with the comparator group at times 2 and 3 (p < 0.05).
","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Frawley', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, 47 - 49 Moorooduc Highway, PO Box 527, Frankston, Victoria, 3199, Australia. Helena.frawley@monash.edu.'}, {'ForeName': 'Kuan-Yin', 'Initials': 'KY', 'LastName': 'Lin', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, 47 - 49 Moorooduc Highway, PO Box 527, Frankston, Victoria, 3199, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, 161 Barry Street, Carlton, Victoria, 3053, Australia.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Higgins', 'Affiliation': 'Department of Physical Therapy, National Cheng Kung University, No.1, Ta-Hsueh Road, Tainan, 701, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Alpha Crucis Group, P.O. Box 4103, Langwarrin, Victoria, 3910, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Department of Physical Therapy, National Cheng Kung University, No.1, Ta-Hsueh Road, Tainan, 701, Taiwan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04931-w']
951,31749143,Baseline findings and safety of infrequent vs. frequent screening of human papillomavirus vaccinated women.,"Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years. We report here the baseline findings and interim results of safety and accuracy of infrequent screening among HPV16/18 vaccinated females. The entire 1992-1994 birth-cohorts (30,139 females) were invited to a community-randomized HPV16/18-vaccination trial. A total of 9,482 female trial participants received HPV16/18-vaccination in 2007-2009 at age of 13-15. At age 22, 4,273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28; Arm 1: 2,073 females) vs. infrequent screening (age 28; Arm 2: 2,200 females) in 2014-2017. Females (1,329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3. Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types were: 0.5% (53/1,000 follow-up years, 10 4  ) and 25% (2,530/10 4  ) in the frequently screened Arm 1; 0.2% (23/10 4  ) and 24% (2,413/10 4  ) in the infrequently screened Arm 2; and 3.1% (304/10 4  ) and 23% (2,284/10 4  ) in the safety Arm 3. Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings were: 0.3 and 4.2% (Arm 1), 0.4 and 5.3% (Arm 2) and 0.3 and 4.7% (Arm 3). Equally rare HSIL/CIN3 findings in the infrequently screened safety Arm A3 (0.4%) and in the frequently screened Arm 1 (0.4%) indicate no safety concerns on infrequent screening despite the up to 10 times higher HPV16/18 baseline prevalence and incidence in the former.",2020,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"['The entire 1992-94 birth-cohorts (30139 females', 'A total of 9,482 female trial participants received HPV16/18-vaccinationin 2007-09 at age of 13-15', 'Females (1329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3', 'HPV16/18 vaccinated females', 'At age 22, 4273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28)(Arm 1: 2073females) vs. infrequent screening (age 28)(Arm 2: 2200females) in 2014-2017', 'human papillomavirus vaccinated women']",[],"['safety Arm 3.Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings', 'Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types']","[{'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C1510966', 'cui_str': 'ASC-H'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0201679', 'cui_str': 'Human papillomavirus typing (procedure)'}]",94.0,0.0697308,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Louvanto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Family Federation Finland, Helsinki, Finland.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Baussano', 'Affiliation': 'Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bly', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Heikkilä', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Huhtinen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Ikonen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Karttunen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Nummela', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Söderlund-Strand', 'Affiliation': 'Department of Clinical Microbiology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Veivo', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Elfstöm', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.32802']
952,31270591,Comparable clinical outcome and implant longevity after CT- or MRI-based patient-specific instruments for total knee arthroplasty: a 2-year follow-up of a RCT.,"PURPOSE


Patient-specific instruments (PSI) are already widespread used in total knee arthroplasty (TKA). Either computed tomography (CT) scans or magnetic resonance imaging (MRI) scans are used pre-operatively to create jigs to guide resection during surgery. This study is a sequel of previous work that showed significantly more radiological outliers for posterior slope when CT-based guides were used. The aim of this study was to assess differences in revision rate and clinical outcome between the two groups at 2-year follow-up.
METHODS


At the 2-year follow-up, 124 patients were analysed in this prospective, randomised single-blind study. A survival analysis with revision of the TKA as endpoint was performed. Patients fulfilled four patient-reported outcome measurements (PROMs). Scores on the questionnaires were compared between both groups at the different follow-up visits.
RESULTS


At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery. Postoperatively, the PROMs significantly improved within each group compared with the pre-operative values. There were no significant differences for the PROMs between both groups at the 2-years follow-up.
CONCLUSIONS


Although previous results showed more outliers regarding posterior slope for CT-based PSIs, no difference in revision rate or the outcome of PROMs was found at 2-year follow-up. Further research to determine what the influence is of radiological outliers on implant survival and clinical outcomes is necessary.
LEVEL OF EVIDENCE


I.",2020,"At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery.","['124 patients', 'total knee arthroplasty']","['computed tomography (CT) scans or magnetic resonance imaging (MRI) scans', 'CT- or MRI-based patient-specific instruments']","['survival rates', 'revision rate', 'revision rate and clinical outcome', 'PROMs']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}]",124.0,0.0473502,"At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery.","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Thijs', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Dieuwertje', 'Initials': 'D', 'LastName': 'Theeuwen', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Boonen', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'van Haaren', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Hendrickx', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Rein', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Borghans', 'Affiliation': 'Department of Radiology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Nanne', 'Initials': 'N', 'LastName': 'Kort', 'Affiliation': ', Roosteren, The Netherlands.'}, {'ForeName': 'Martijn G M', 'Initials': 'MGM', 'LastName': 'Schotanus', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands. martijnschotanus@hotmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05616-x']
953,31060939,"Effects of Autologous Platelet Rich Plasma on Intraoperative Transfusion and Short-Term Outcomes in Total Arch Replacement (Sun's Procedure): A Prospective, Randomized Trial.","OBJECTIVE


To observe the effect of collecting and retransfusing autologous platelet rich plasma (aPRP) on the amount of allogeneic blood usage in total arch replacement (Sun's surgery) and the outcomes 30 days after surgery.
DESIGN


A prospective, randomized trial.
SETTING


A tertiary university hospital specialized in cardiovascular diseases.
PARTICIPANTS


The study comprised 120 patients undergoing Sun's surgery for Stanford type A acute aortic dissection.
INTERVENTIONS


aPRP was harvested before incision and was re-transfused after heparin neutralization for patients in the treatment group.
MEASUREMENTS AND MAIN RESULTS


There was no significant difference in preoperative demographic data between the 2 study groups. Intraoperative transfusions of erythrocyte (p = 0.009), plasma (p = 0.017), cryoprecipitate (p = 0.002), and platelets (p < 0.001) in the treatment group were reduced significantly. In addition, less blood loss was observed in the treatment group (p = 0.002). The durations of postoperative mechanical ventilation (p = 0.029) and hospitalization (p = 0.002) of the treatment group were significantly shorter. There were no statistically significant differences in the length of intensive care unit stay, the incidence of complications, and mortality 30 days after surgery.
CONCLUSION


In total arch replacement (Sun's surgery), collecting and retransfusing aPRP reduced intraoperative transfusions of erythrocyte, plasma, and cryoprecipitate and decreased the duration of postoperative mechanical ventilation and hospitalization. This technique had no significant effect on the incidence of complications and mortality 30 days postoperatively.",2019,"Intraoperative transfusions of erythrocyte (p = 0.009), plasma (p = 0.017), cryoprecipitate (p = 0.002), and platelets (p < 0.001) in the treatment group were reduced significantly.","[""total arch replacement (Sun's surgery"", 'A tertiary university hospital specialized in cardiovascular diseases', ""120 patients undergoing Sun's surgery for Stanford type A acute aortic dissection"", ""Total Arch Replacement (Sun's Procedure""]","['Autologous Platelet Rich Plasma', 'collecting and retransfusing autologous platelet rich plasma (aPRP']","['blood loss', 'preoperative demographic data', 'length of intensive care unit stay, the incidence of complications, and mortality 30 days after surgery', 'intraoperative transfusions of erythrocyte, plasma, and cryoprecipitate and decreased the duration of postoperative mechanical ventilation and hospitalization', 'hospitalization', 'durations of postoperative mechanical ventilation', 'Intraoperative transfusions of erythrocyte']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0340643', 'cui_str': 'Aortic Dissection'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",120.0,0.0778275,"Intraoperative transfusions of erythrocyte (p = 0.009), plasma (p = 0.017), cryoprecipitate (p = 0.002), and platelets (p < 0.001) in the treatment group were reduced significantly.","[{'ForeName': 'Wen-Zhi', 'Initials': 'WZ', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Tianjin Chest Hospital, Tianjin Cardiovascular Diseases Institute, Tianjin, China.'}, {'ForeName': 'Jian-Xu', 'Initials': 'JX', 'LastName': 'Er', 'Affiliation': 'Department of Anesthesiology, Tianjin Chest Hospital, Tianjin Cardiovascular Diseases Institute, Tianjin, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Tianjin Chest Hospital, Tianjin Cardiovascular Diseases Institute, Tianjin, China.'}, {'ForeName': 'Qing-Liang', 'Initials': 'QL', 'LastName': 'Chen', 'Affiliation': 'Department of Cardio-Vascular Surgery, Tianjin Chest Hospital, Tianjin Cardiovascular Diseases Institute, Tianjin, China.'}, {'ForeName': 'Jian-GeHan', 'Initials': 'JG', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Tianjin Chest Hospital, Tianjin Cardiovascular Diseases Institute, Tianjin, China. Electronic address: hanjiange@163.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.02.033']
954,31256214,Time-dependent surgical instrument contamination begins earlier in the uncovered table than in the covered table.,"PURPOSE


Time-dependent surgical instrument contamination and the effect of covering during arthroplasty have not been investigated. This study aimed to evaluate time-dependent contamination of surgical instruments and the effect of covering on contamination as well as to perform bacterial typing of contaminated samples. The hypothesis was that covering the surgical instruments would decrease contamination rates.
METHODS


Sixty patients who underwent total knee arthroplasty were randomized and divided into two groups: surgical instruments covered with a sterile towel or surgical instruments left uncovered. K-wires were used to extract microbiological samples. The K-wires were placed in a liquid culture medium at 0, 15, 30, 60, 90, and 120 min. After 24-h incubation period, samples from liquid cultures were cultured on blood agar using swabs. Samples with growth after 48 h were considered contaminated. Microscopic, staining, and biochemical properties were used for bacterial typing.
RESULTS


Bacterial growth started after 30 and 60 min in the uncovered and covered groups, respectively. An increase in the number of K-wires contaminated with time was detected. At least 10,000 CFU/mL bacterial load was observed in the culture samples. Contamination was more significant in the uncovered group. A statistically significant difference in contamination was found between the uncovered and covered groups at 30-, 60-, 90-, and 120 min (p = 0.035, p = 0.012, p = 0.024, and p = 0.037, respectively). The most common bacteria on the contaminated instruments were coagulase-negative Staphylococci (60.4%), Staphylococcus aureus (22.9%), and Streptococcus agalactia (16.7%), respectively.
CONCLUSION


The risk of contamination increases with time. However, it may decrease if surgical instruments are covered. In the clinical practice, empiric antibiotic regimens based on the type of identified microorganisms in this study may be developed for postoperative periprosthetic joint infection prophylaxis.
LEVEL OF EVIDENCE


Prognostic, Level II.",2020,"The most common bacteria on the contaminated instruments were coagulase-negative Staphylococci (60.4%), Staphylococcus aureus (22.9%), and Streptococcus agalactia (16.7%), respectively.
",['Sixty patients who underwent total knee arthroplasty'],['surgical instruments covered with a sterile towel or surgical instruments left uncovered'],"['Streptococcus agalactia', 'number of K-wires', 'contamination rates', 'contamination']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0038928', 'cui_str': 'Surgical Instruments'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0336616', 'cui_str': 'Towel, device (physical object)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0439845', 'cui_str': 'Uncovered (qualifier value)'}]","[{'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0152158', 'cui_str': 'Failure of lactation (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}]",60.0,0.0449136,"The most common bacteria on the contaminated instruments were coagulase-negative Staphylococci (60.4%), Staphylococcus aureus (22.9%), and Streptococcus agalactia (16.7%), respectively.
","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Uzun', 'Affiliation': 'Department of Orthopedics and Traumatology, Training and Research Hospital, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Abdulhamit', 'Initials': 'A', 'LastName': 'Misir', 'Affiliation': 'Department of Orthopedics and Traumatology, Gaziosmanpasa Taksim Training and Research Hospital, Karayollari Mah. Osmanbey Cad. 621. Sk, Gaziosmanpasa, Istanbul, Turkey. misirabdulhamitmd@gmail.com.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ozcamdalli', 'Affiliation': 'Department of Orthopedics and Traumatology, Training and Research Hospital, Ahi Evran University, Bursa, Turkey.'}, {'ForeName': 'Emine Eylul', 'Initials': 'EE', 'LastName': 'Kizkapan', 'Affiliation': 'Department of Internal Medicine, Ilker Celikcan Physical Therapy and Rehabilitation Hospital, Bursa, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Cirakli', 'Affiliation': 'Department of Orthopedics and Traumatology, Training and Research Hospital, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Mustafa Kerem', 'Initials': 'MK', 'LastName': 'Calgin', 'Affiliation': 'Department of Microbiology, Training and Research Hospital, Ordu University, Ordu, Turkey.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05607-y']
955,31274110,Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial.,"BACKGROUND


In the PREVAIL study, enzalutamide provided significant improvements versus placebo in clinical outcomes in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC). The association of post-treatment prostate-specific antigen (PSA) decline with clinical outcomes may provide important prognostic information.
OBJECTIVE


To evaluate associations between the magnitude of PSA decline from baseline to month 3 and clinical outcomes among enzalutamide recipients.
DESIGN, SETTING, AND PARTICIPANTS


This was a post hoc retrospective analysis of PREVAIL, an international, randomized, double-blind, placebo-controlled phase 3 study. Men with mCRPC and no prior chemotherapy from the enzalutamide arm were included (n=872). Patients were grouped by confirmed maximal PSA decline from baseline to month 3 of treatment (n=795 evaluable).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Primary outcomes were overall survival and radiographic progression-free survival. Secondary outcomes included PSA progression-free survival, radiographic response, and degradation of Functional Assessment of Cancer Therapy-Prostate score, which were estimated using the Kaplan-Meier method.
RESULTS AND LIMITATIONS


Following 3mo of enzalutamide treatment, 88% (701/795), 80% (639/795), and 39% (307/795) of patients had postbaseline confirmed maximal PSA declines of ≥30%, ≥50%, and ≥90%, respectively, whereas 12% (94/795) had no confirmed maximal PSA decline or a decline of <30%. Greater degrees of PSA decline within the first 3mo of enzalutamide treatment were increasingly associated with longer overall survival, time to PSA and radiographic progression, higher objective soft-tissue responses, and longer time to quality-of-life deterioration than no PSA decline or declines of <30% from baseline. PSA flares (rise followed by fall) after enzalutamide treatment were rare (<1%).
CONCLUSIONS


The magnitude of PSA decline after 3mo of enzalutamide therapy was strongly associated with better clinical and patient-reported outcomes. This updated prognostic information is of clinical value to this patient population and their health care providers.
PATIENT SUMMARY


We report that decreases in PSA levels are closely linked to better health and survival after 3mo of enzalutamide treatment in men with metastatic prostate cancer. The PREVAIL trial is registered at clinicaltrials.gov as NCT01212991.",2019,"Greater degrees of PSA decline within the first 3mo of enzalutamide treatment were increasingly associated with longer overall survival, time to PSA and radiographic progression, higher objective soft-tissue responses, and longer time to quality-of-life deterioration than no PSA decline or declines of <30% from baseline.","['chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC', 'men with metastatic prostate cancer', 'recipients', 'Men with Metastatic Castration-resistant Prostate Cancer Treated with', 'Men with mCRPC and no prior chemotherapy from the enzalutamide arm were included (n=872']","['enzalutamide', 'placebo', 'Enzalutamide']","['overall survival, time to PSA and radiographic progression, higher objective soft-tissue responses, and longer time to quality-of-life deterioration', 'maximal PSA decline', 'PSA flares', 'PSA progression-free survival, radiographic response, and degradation of Functional Assessment of Cancer Therapy-Prostate score, which were estimated using the Kaplan-Meier method', 'PSA decline', 'PSA levels', 'health and survival', 'overall survival and radiographic progression-free survival', 'maximal PSA declines']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.465756,"Greater degrees of PSA decline within the first 3mo of enzalutamide treatment were increasingly associated with longer overall survival, time to PSA and radiographic progression, higher objective soft-tissue responses, and longer time to quality-of-life deterioration than no PSA decline or declines of <30% from baseline.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA. Electronic address: andrew.armstrong@duke.edu.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Iversen', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Phung', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, The Netherlands.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Parli', 'Affiliation': 'Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Krivoshik', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}]",European urology oncology,['10.1016/j.euo.2018.11.005']
956,31256765,'Placement budgets' for supported employment: impact on employment rates in a multicentre randomised controlled trial.,"BACKGROUND


The most effective rehabilitation model for job (re-)entry of people with mental illness is supported employment. A barrier to introducing supported employment into standard care is its temporally unlimited provision, which conflicts with health and social legislation in many European countries.
AIMS


To test the impact of different 'placement budgets', i.e. a predefined maximum time budget for job seeking until take-up of competitive employment.
METHOD


Participants (116) were randomly assigned to 25 h, 40 h or 55 h placement budgets in an intent-to-treat analysis. We applied the individual placement and support model over 24 months, following participants for 36 months. Primary outcome was employment in the labour market for at least 3 months.
RESULTS


The proportion of participants obtaining competitive employment was 55.1% in the 25 h group, 37.8% in the 40 h group and 35.8% in the 55 h group. In a Cox regression analysis, time to employment was slightly lower in the 25 h group relative to the 40 h (hazard ratio 1.78, 95% CI 0.88-3.57, P = 0.107) and 55 h groups (hazard ratio 1.74, 95% CI 0.86-3.49, P = 0.122), but this was not statistically significant. The vast majority of all participants who found a job did so within the first 12 months (80.4%).
CONCLUSION


A restricted time budget for job finding and placement does not affect the rate of successful employment. In accordance with legislation, a restriction of care provision seems justified and enhances the chances of supported employment being introduced in statutory services.",2020,"The vast majority of all participants who found a job did so within the first 12 months (80.4%).
","['job (re-)entry of people with mental illness', 'Participants (116']",[],"['proportion of participants obtaining competitive employment', 'rate of successful employment', 'time to employment', 'employment in the labour market for at least 3 months']","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]",[],"[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",116.0,0.201813,"The vast majority of all participants who found a job did so within the first 12 months (80.4%).
","[{'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Rössler', 'Affiliation': 'Professor, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland; Institute of Psychiatry, Laboratory of Neuroscience (LIM 27), University of Sao Paulo, Brazil; and Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Senior Consultant, Psychiatrische Dienste Aargau AG, Klinik für Psychiatrie und Psychotherapie, Switzerland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nordt', 'Affiliation': 'Senior Researcher, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Haker', 'Affiliation': 'Senior Researcher, Translational Neuromodeling Unit, Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rüsch', 'Affiliation': 'Professor, Section of Public Mental Health, University of Ulm, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Hengartner', 'Affiliation': 'Senior Lecturer, Department of Applied Psychology, Zurich University of Applied Sciences, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.154']
957,32409433,Antivirals for COVID-19.,"Drugs targeting RNA respiratory viruses has resulted in few effective therapies, highlighting challenges for antivirals to treat COVID-19. Several antivirals are being investigated for symptomatic COVID-19 but no definitive data support their clinical use. Remdesivir, with good in vitro activity against SARS-CoV2, appeared to result in favorable outcomes for hospitalized patients in a compassionate use series with shortened time to recovery and a modest decrease in mortality. Currently, remdesivir is available in phase III clinical trials, the compassionate use program, and eventually through the emergency use authorization. A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility. Antivirals to treat influenza (oseltamivir) have limited activity against SARS-CoV-2, but favipiravir and umifenovir, influenza antivirals available internationally, have distinct viral targets and require further investigation. Antivirals with evidence of clinical activity must be studied as treatment and prophylaxis for those at high risk for severe COVID-19.",2020,A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility.,[],"['lopinavir/ritonavir', 'influenza (oseltamivir']",['mortality'],[],"[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0487895,A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility.,"[{'ForeName': 'Pavithra', 'Initials': 'P', 'LastName': 'Srinivas', 'Affiliation': 'Inpatient Pharmacy, Cleveland Clinic.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Sacha', 'Affiliation': 'Inpatient Pharmacy, Cleveland Clinic.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Koval', 'Affiliation': 'Infectious Disease, Respiratory Institute, Cleveland Clinic.'}]",Cleveland Clinic journal of medicine,['10.3949/ccjm.87a.ccc030']
958,31248751,Effect of combination of non-slip element balloon and drug-coating balloon for in-stent restenosis lesions (ELEGANT study).,"BACKGROUND


In-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT).
METHODS


Patients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD)-follow-up MLD] at 8 months.
RESULTS


One hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p=0.002) and geographical miss (6.9% versus 21.9%, p=0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17±0.42mm versus 1.06±0.35mm, p=0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85±1.67mm 2  versus 3.81±1.93mm 2 , p=0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78±3.26mm versus 6.97±4.59mm, p=0.04), but average in-segment late loss was similar between the two groups (0.28±0.45mm versus 0.27±0.38mm, p=0.75).
CONCLUSION


Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.",2019,Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions.,"['Patients were eligible for the study if one or more in-stent restenosis lesions', 'One hundred and five patients']","['non-slip element balloon (NSE', 'NSE pre-dilatation', 'paclitaxel-coating balloon', 'NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group', 'POBA', 'combination of non-slip element balloon and drug-coating balloon', 'NSE', 'optical coherence tomographic imaging (OCT']","['Acute gain', 'geographical miss', 'average lesion length', 'average in-segment late loss', 'segment late loss [post minimal lumen diameter (MLD)-follow-up MLD', 'Balloon slippage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0304222', 'cui_str': 'Drug coating (product)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic Leukoencephalopathy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]",105.0,0.0375192,Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions.,"[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan. Electronic address: jiro@mitsuihosp.or.jp.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Cardiovascular Center, Kyoto-Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tobaru', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Hisayuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Division of Cardiology, Seirei Hamamatsu General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zen', 'Affiliation': 'Department of Cardiology, Omihachiman Community Medical Center, Shiga, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': ""Cardiovascular Center, St Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, Itabashi Chuo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Fusazaki', 'Affiliation': 'Division of Cardiology, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.04.011']
959,30910531,"A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial.","BACKGROUND


Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care.
METHODS


In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117.
FINDINGS


The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7-100·0) of seropositive women in intervention clinics and 43·2% (2·6-83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8-99·0]; p=0·0028).
INTERPRETATION


A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment.
FUNDING


Bill & Melinda Gates Foundation.",2019,Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092).,"['pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit', 'pregnant women', '18\u2008357 women were enrolled at the 13 intervention clinics and 17\u2008679 women were enrolled at the 13 control clinics at their first antenatal care visit', 'pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia', '26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a']","['behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group', 'multifaceted intervention']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030829', 'cui_str': 'penicillin G benzathine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0039128', 'cui_str': 'Great Pox'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}]",[],18357.0,0.140212,Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092).,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO, Geneva, Switzerland.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Antoinette K', 'Initials': 'AK', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Banda', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Belizán', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bergel', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Berrueta', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina. Electronic address: mberrueta@iecs.org.ar.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Bertrand', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina (UNC) School of Medicine, UNC Hospitals, Chapel Hill, NC, USA.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Cafferata', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Ciganda', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Donnay', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'García Elorrio', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Gibbons', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Jerker', 'Initials': 'J', 'LastName': 'Liljestrand', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lusamba', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Arlette K', 'Initials': 'AK', 'LastName': 'Mavila', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Mazzoni', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Dalau M', 'Initials': 'DM', 'LastName': 'Nkamba', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Friday H', 'Initials': 'FH', 'LastName': 'Mwanakalanga', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Mwapule Tembo', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Musaku', 'Initials': 'M', 'LastName': 'Mwenechanya', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Pyne-Mercier', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Spira', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Jean D', 'Initials': 'JD', 'LastName': 'Wetshikoy', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Buekens', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30075-0']
960,31266607,"The effect of auricular acupressure on sleep in breast cancer patients undergoing chemotherapy: A single-blind, randomized controlled trial.",,2019,,['breast cancer patients undergoing'],"['auricular acupressure', 'chemotherapy']",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.478851,,"[{'ForeName': 'Hyeon Gyeong', 'Initials': 'HG', 'LastName': 'Yoon', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hyojung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, South Korea. Electronic address: hyojungp@ewha.ac.kr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.05.009']
961,31266608,A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects.,"AIM


To evaluate the efficacy of mindfulness-based stress reduction on objective and subjective sleep parameters and hypnotic medication use of patients with insomnia secondary to cervical cancer.
METHODS


This was a randomized controlled trial enrolled insomnia patient who were caused or worsened by cervical cancer. Seventy patients with insomnia caused or aggravated by cervical cancer were at random divided into either a usual care group or an 8-week mindfulness-based stress reduction group. Subjective sleep parameters, objective sleep parameters and hypnotic medication consumption were assessed at baseline, after the program, 6- and 12-month after finishing the interventions.
RESULTS


The results showed that mindfulness-based stress reduction had a positive effect on subjective sleep parameters (Total wake time: ∆ = 45.32, P < 0.05; Sleep efficacy: ∆ = 6.87, P < 0.05; Total sleep time: ∆ = 22.22, P < 0.01). Compared with control group, polysomnography data in mindfulness-based stress reduction group were not improved significantly. There were no associations between subjective sleep parameters and objective sleep parameters.
CONCLUSION


Mindfulness-based stress reduction had a definite impact on patients with insomnia that was secondary to cervical cancer just after the intervention, but no long-term influences.
TRIAL REGISTRATION


ChiCTR1800018571; 9/25/2018; retrospectively registered.",2019,"Compared with control group, polysomnography data in mindfulness-based stress reduction group were not improved significantly.","['Seventy patients with insomnia caused or aggravated by cervical cancer', 'insomnia secondary to cervical cancer', 'enrolled insomnia patient who were caused or worsened by cervical cancer', 'patients with insomnia secondary to cervical cancer']","['usual care group or an 8-week mindfulness-based stress reduction group', 'mindfulness-based stress reduction']","['subjective sleep parameters and objective sleep parameters', 'subjective sleep parameters', 'Sleep efficacy', 'Subjective sleep parameters, objective sleep parameters and hypnotic medication consumption', 'Total sleep time']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors (finding)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",70.0,0.0151672,"Compared with control group, polysomnography data in mindfulness-based stress reduction group were not improved significantly.","[{'ForeName': 'Huashuang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing, Wuchang University of Technology, No. 106 Jiangxia Road, Wuhan, China. Electronic address: 13972456310@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, the Third Hospital of Wuhan, No.1 Guanshan Road, Wuhan, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'College of Nursing, Wuchang University of Technology, No. 106 Jiangxia Road, Wuhan, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, Wuchang University of Technology, No. 106 Jiangxia Road, Wuhan, China.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.05.016']
962,31797034,Inactivated P. aeruginosa restores immune imbalance of chronic idiopathic urticaria.,"The main pathology involved in chronic idiopathic urticaria (CIU) is immunological dysfunction which mainly adapts to the immune system of body. Pseudomonas aeruginosa-mannose-sensitive hemagglutinin (PA) is an inactivated Pseudomonas aeruginosa biological product which displays a broad immune regulatory effect. The current study was designed to explore the protective nature of PA as an immune regulator in CIU. The participants were randomly divided into CIU + PA, CIU, control + PA and control group. lg E, anti FcεRI, anti IgE antibody, IL-4, IL-17, TGF-β1 and interferon-γ in the sera were assayed by ELISA. Then CD4 +  T cells and CD19 +  B cells were isolated from peripheral blood of patients with CIU (n = 10) and healthy control (n = 10). CD4 +  T cells and CD19 +  B proliferation and apoptosis were analyzed through CCK-8 and flow cytometry respectively. T helper cells differentiations were assessed by real-time PCR. The results revealed that compared with the control group, the curative effect of CIU + PA group was more effective than that of the CIU control group. There was a hyper proliferation of CD19 +  B cells in the CIU patients. Moreover, it was also discovered that presence of Th1 decreased while Th2 cells increased in CIU patients. PA significantly inhibited the proliferation of CD19 +  B and Th2 cells but at the same time promoted the proliferation of Th1 compared to healthy control. The conclusion arrived at from this study is that the PA displayed a remarkable regulatory effect in CD4 +  T cells and CD19 +  B cells function by promoting Th1 but inhibited Th2 and the hyperfunction of B cells of CIU patients.",2020,PA significantly inhibited the proliferation of CD19 +  B and Th2 cells but at the same time promoted the proliferation of Th1 compared to healthy control.,['chronic idiopathic urticaria'],"['CIU\u2009+\u2009PA, CIU, control\u2009+\u2009PA and control group', 'Pseudomonas aeruginosa-mannose-sensitive hemagglutinin (PA']","['CD4 +  T cells and CD19 +  B cells function', 'T helper cells differentiations', 'hyper proliferation of CD19 +  B cells', ' IL-4, IL-17, TGF-β1 and interferon-γ in the sera', 'curative effect', 'CD4 +  T cells and CD19 +  B proliferation and apoptosis', 'lg E, anti FcεRI, anti IgE antibody', 'proliferation of CD19 +  B and Th2 cells']","[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0051978', 'cui_str': 'anti-IgE antibodies'}, {'cui': 'C0242633', 'cui_str': 'T Helper2 Cells'}]",,0.0167054,PA significantly inhibited the proliferation of CD19 +  B and Th2 cells but at the same time promoted the proliferation of Th1 compared to healthy control.,"[{'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Jian', 'Affiliation': 'Department of Pharmacy, Shandong Provincial Third Hospital, 12 Wuyingshan Middle Road, Tianqiao District, Jinan, 250031, Shandong, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chao', 'Affiliation': 'Department of Pharmacy, Shandong Provincial Third Hospital, 12 Wuyingshan Middle Road, Tianqiao District, Jinan, 250031, Shandong, China. chenjianhua86@163.com.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Xiaoli', 'Affiliation': 'Department of Pharmacy, Shandong Provincial Third Hospital, 12 Wuyingshan Middle Road, Tianqiao District, Jinan, 250031, Shandong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Aiwu', 'Affiliation': 'Department of Pharmacy, Shandong Provincial First Hospital, Jinan, 250021, Shandong, China.'}]",Archives of dermatological research,['10.1007/s00403-019-02019-3']
963,31166697,Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN.,"BACKGROUND


We assessed the safety profile of lasmiditan, a selective 5-HT 1F  receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine.
METHODS


SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses.
RESULTS


The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events.
CONCLUSIONS


As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting.
TRIAL REGISTRATION AT CLINICALTRIALS.GOV


SAMURAI (NCT02439320) and SPARTAN (NCT02605174).",2019,"There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]).","['Patients reporting\u2009≥', '1262 patients assigned', 'patients with migraine', 'acute treatment of migraine']","['Placebo', 'placebo', 'oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo']","['dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia', 'ischemic events', 'deaths; serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.317753,"There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rizzoli', 'Affiliation': ""2 Brigham and Women's Faulkner Hospital, Boston, MA, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Liffick', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sherie A', 'Initials': 'SA', 'LastName': 'Dowsett', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Buchanan', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419855080']
964,31685516,Multicentre randomised double-blind placebo controlled trial of combination vancomycin and cefazolin surgical antibiotic prophylaxis: the Australian surgical antibiotic prophylaxis (ASAP) trial.,"INTRODUCTION


Resistant Gram-positive organisms, such as methicillin-resistant staphylococci, account for a significant proportion of infections following joint replacement surgery. Current surgical antimicrobial prophylaxis guidelines recommend the use of first-generation or second-generation cephalosporin antibiotics, such as cefazolin. Cefazolin, however, does not prevent infections due to these resistant organisms; therefore, new prevention strategies need to be examined. One proposed strategy is to combine a glycopeptide antibiotic with cefazolin for prophylaxis. The clinical benefit and cost-effectiveness of this combination therapy compared with usual therapy, however, have not been established.
METHODS AND ANALYSIS


This randomised, double-blind, parallel, superiority, placebo-controlled, phase 4 trial will compare the incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness of surgical prophylaxis with cefazolin  plus  vancomycin to that with cefazolin  plus  placebo. The study will be performed in patients undergoing joint replacement surgery. In the microbiological sub-studies, we will examine the incidence of SSIs in participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2). The trial will recruit 4450 participants over a 4-year period across 13 orthopaedic centres in Australia. The primary outcome is the incidence of SSI at 90 days post index surgery. Secondary outcomes include the incidence of SSI according to joint and microorganism and other healthcare associated infections. Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality. The primary and secondary analysis will be a modified intention-to-treat analysis consisting of all randomised participants who undergo eligible surgery. We will also perform a per-protocol analysis.
ETHICS AND DISSEMINATION


The study protocol was reviewed and approved by The Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/102) on 9 July 2018. Study findings will be disseminated in the printed media, and learnt forums.
TRIAL REGISTRATION NUMBER


ACTRN12618000642280.",2019,"Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality.","['patients undergoing joint replacement surgery', '4450 participants over a 4-year period across 13 orthopaedic centres in Australia', 'participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2']","['cefazolin', 'cefazolin  plus  placebo', 'placebo', 'cefazolin  plus  vancomycin', 'Cefazolin', 'combination vancomycin and cefazolin surgical antibiotic prophylaxis']","['incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness', 'incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality', 'incidence of SSI according to joint and microorganism and other healthcare associated infections', 'incidence of SSI at 90 days post index surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0010356', 'cui_str': 'Healthcare Associated Infections'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",13.0,0.67242,"Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality.","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Peel', 'Affiliation': 'Infectious Diseases, Monash University, Melbourne, Victoria, Australia Trisha.Peel@monash.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Astbury', 'Affiliation': 'Infectious Diseases, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infectious Diseases Unit, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paterson', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Buising', 'Affiliation': 'Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spelman', 'Affiliation': ""Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Tran-Duy', 'Affiliation': 'Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'de Steiger', 'Affiliation': 'Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033718']
965,31235418,A randomized unblinded trial to compare effects of intensive versus conventional lipid-lowering therapy in patients undergoing renal artery stenting.,"BACKGROUND


Although current guidelines recommend the use of statins for severe atherosclerotic renal artery stenosis (ARAS), the renal protection of intensive lipid-lowering therapy in patients with ARAS who underwent stent placement remains uncertain. The aim of this study was to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients with ARAS undergoing stent placement.
METHODS


A total 150 patients with severe ARAS undergoing stent placement were randomly (1:1) assigned to receive intensive lipid lowering [target low-density lipoprotein cholesterol (LDL-C) <70mg/dL] or conventional lipid lowering (target LDL-C ≥70mg/dL, <128mg/dL). All patients received rosuvastatin. We adjusted LDL-C to the goal within two months after renal stenting and maintained stability. The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months.
RESULTS


During the study period, LDL-C was lower in the patients with intensive lipid lowering than with conventional lipid lowering (at 12 months 58.0±11.6 vs 85.1±15.5mg/dL, p<0.001). At 12-month follow-up, eGFR (91.8±30.2 vs 78.5±19.5)mL/min·1.73m 2 , p=0.002) and the increase in eGFR compared to baseline [14.8(IQR, 4.1, 26.7) vs -0.4(IQR, -9.5, 8.0)mL/min·1.73m 2 , p<0.001] were higher in the patients with intensive lipid lowering than with conventional lipid lowering. Urinary albumin-creatinine ratio [42.2(IQR, 20.0, 60.9) vs 60.8(IQR, 26.8, 121.6)mg/g, p=0.032] was lower and the decrease in urinary albumin-creatinine ratio compared to baseline [27.4(IQR, 3.0, 53.8) vs -3.1(IQR, -17.3, 30.9)mg/g, p=0.001] was higher in the patients with intensive lipid lowering than with conventional lipid lowering. The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups.
CONCLUSIONS


In patients with severe ARAS undergoing stent placement, intensive lipid lowering showed significant benefits in renal protection over conventional lipid-lowering therapy.",2019,"The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups.
","['patients undergoing renal artery stenting', 'patients with ARAS who underwent stent placement remains uncertain', 'patients with severe ARAS undergoing', 'patients with ARAS undergoing stent placement', 'A total 150 patients with severe ARAS undergoing stent placement', 'severe atherosclerotic renal artery stenosis (ARAS']","['intensive lipid lowering with that of conventional lipid lowering', 'intensive lipid lowering [target low-density lipoprotein cholesterol (LDL-C) <70mg/dL] or conventional lipid lowering (target LDL-C ≥70mg/dL, <128mg/dL', 'stent placement, intensive lipid lowering', 'intensive versus conventional lipid-lowering therapy', 'rosuvastatin']","['urinary albumin-creatinine ratio', 'Urinary albumin-creatinine ratio', 'restenosis rate', 'eGFR', 'change in estimated glomerular filtration rate (eGFR', 'major clinical events', 'renal protection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0340557', 'cui_str': 'Atherosclerotic renal artery stenosis (disorder)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3811844'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",150.0,0.188818,"The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups.
","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiongjing', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiangxiongjing@163.com.'}, {'ForeName': 'Wuqiang', 'Initials': 'W', 'LastName': 'Che', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yubao', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.04.010']
966,32127178,Randomized control trial of opioid- versus nonopioid-based analgesia after thyroidectomy.,"BACKGROUND


Opioid-based analgesia is the most common method for pain control in the postoperative period. Limited data exist to compare the adequacy of pain control in the post thyroidectomy period with nonopioid-based analgesia. We aimed to evaluate the efficacy of nonopioid-based, postoperative analgesia.
METHODS


After institutional review board approval, patients were randomized to 1 of 2 pain control regimens. Sample size was calculated to assess for a pain score difference of 1 based on a visual analog scale. The control group received opioid-based, postoperative analgesia, whereas the study group received nonopioid-based analgesia of acetaminophen and ibuprofen. Pain scores (measured on visual analog scale) and opioid use (converted to morphine equivalent dose) were measured after completion of the operation.
RESULTS


The sample sizes for the study and control groups were 49 and 46 patients, respectively. The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference. Morphine equivalent opioid requirement for pain control in the postoperative period was 0.8 vs 6.9 mg (P < .01), respectively.
CONCLUSION


In a randomized control trial, we showed that patients treated with nonopioid analgesia had similar pain scores to those treated with opioids, with the benefit of having lower opioid exposure in the perioperative period.",2020,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.",[],"['nonopioid-based analgesia of acetaminophen and ibuprofen', 'opioid-based, postoperative analgesia', 'opioid- versus nonopioid-based analgesia after thyroidectomy', 'nonopioid analgesia', 'Morphine']","['pain score', 'pain control', 'pain scores', 'Pain scores']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",,0.118298,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.","[{'ForeName': 'Vardan', 'Initials': 'V', 'LastName': 'Papoian', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC. Electronic address: vpapoian@gmail.com.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Handy', 'Affiliation': 'Department of Anesthesiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Villano', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Tolentino', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Mohamed T', 'Initials': 'MT', 'LastName': 'Hassanein', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Nosanov', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Felger', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}]",Surgery,['10.1016/j.surg.2020.01.011']
967,31799940,Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial.,"BACKGROUND


Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making.
OBJECTIVE


The objective of this study was to develop a literacy-sensitive Web-based patient decision aid based on the Ottawa decision support framework, and through a randomized clinical trial estimate the effectiveness of the patient decision aid in improving patient knowledge and their involvement in decision making.
METHODS


We conducted population decisional needs assessments in a nationwide sample of patients, caregivers, community advocates, policy makers, and health care providers using qualitative interviews to identify decisional conflict, knowledge and expectations, values, support and resources, decision types, timing, stages and learning, and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Alpha testing of the patient decision aid prototype was done to establish usability and the accuracy of the information it conveyed, and then was followed by iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the patient decision aid.
RESULTS


In a decisional needs assessment, 223 stakeholders described their preferences, helping to guide the development of the patient decision aid, which then underwent alpha testing by 30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders. In a randomized clinical trial, 120 participants were assigned to either the patient decision aid or standard care (SC) arm. Qualitative interviews revealed high levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making. On the acceptability survey, 72% (86/120) of participants rated the patient decision aid as good or excellent. Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months. However, there was no improvement in terms of the change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies at 6 months. The large amount of missing data from survey completion limited our ability to draw conclusions about the effectiveness of the patient decision aid. The patient decision aid met 61 of 62 benchmarks of the international patient decision aid collaboration standards for content, development process, and efficacy.
CONCLUSIONS


We have developed a patient decision aid for sickle cell disease with extensive input from stakeholders and in a randomized clinical trial demonstrated its acceptability and utility in education and decision making. We were unable to demonstrate its effectiveness in improving patient knowledge and involvement in decision making.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597.",2019,"Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months.","['120 participants', 'Sickle Cell Disease', '30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders', 'adults and of caregivers of pediatric patients']","['Web-Based Patient Decision Aid', 'patient decision aid or standard care (SC']","['levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making', 'informed sub-score of decisional conflict', 'decisional self-efficacy', 'change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",223.0,0.202862,"Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months.","[{'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Leong', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Nonita', 'Initials': 'N', 'LastName': 'Mittal', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Veludhandi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Anh-Phuong', 'Initials': 'AP', 'LastName': 'Pham', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Alankrita', 'Initials': 'A', 'LastName': 'Taneja', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Kamesh', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Julum', 'Initials': 'J', 'LastName': 'Nwanze', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Andrea Marie', 'Initials': 'AM', 'LastName': 'Matthews', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Vazquez Olivieri', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Santhi', 'Initials': 'S', 'LastName': 'Arjunan', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Ifechi', 'Initials': 'I', 'LastName': 'Okonkwo', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Lukombo', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lane', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}]",Journal of medical Internet research,['10.2196/14462']
968,31104507,Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure.,"BACKGROUND


Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed.
STUDY DESIGN/METHODS


REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score.
RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures.
CONCLUSION


Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome.
CLINICALTRIALS.GOV IDENTIFIER NUMBER


NCT02614261.",2019,"RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49).","['patients with chronic migraine and a history of preventive treatment failure', 'patients with chronic migraine who have failed ≥2 or ≥1 preventives previously', 'patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed', 'patients with chronic migraine', 'patients who failed ≥2 and ≥1 prior preventives and who never failed previously']","['Galcanezumab', 'placebo', 'galcanezumab', 'galcanezumab versus placebo', 'placebo, galcanezumab']","['placebo response', 'number of monthly migraine headache days', 'migraine headache days', 'overall reduction', 'number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score', 'acute medication use and improvements in MSQ RF-R domain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.190411,"RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49).","[{'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': '2 Eli Lilly and Company, Erl Wood Manor, Windlesham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sexson', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Govindan', 'Affiliation': '3 Eli Lilly Services India Private Limited, Bengaluru, Karnataka, India.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': '4 Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': '5 Brain Research Center, National Yang-Ming University, Taipei.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': '7 Northwest Clinical Research Center, Bellevue, WA, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419847957']
969,31797581,Reproducibility of cognitive endpoints in clinical trials: lessons from neurofibromatosis type 1.,"OBJECTIVE


Rapid developments in understanding the molecular mechanisms underlying cognitive deficits in neurodevelopmental disorders have increased expectations for targeted, mechanism-based treatments. However, translation from preclinical models to human clinical trials has proven challenging. Poor reproducibility of cognitive endpoints may provide one explanation for this finding. We examined the suitability of cognitive outcomes for clinical trials in children with neurofibromatosis type 1 (NF1) by examining test-retest reliability of the measures and the application of data reduction techniques to improve reproducibility.
METHODS


Data were analyzed from the STARS clinical trial (n = 146), a multi-center double-blind placebo-controlled phase II trial of lovastatin, conducted by the NF Clinical Trials Consortium. Intra-class correlation coefficients were generated between pre- and post-performances (16-week interval) on neuropsychological endpoints in the placebo group to determine test-retest reliabilities. Confirmatory factor analysis was used to reduce data into cognitive domains and account for measurement error.
RESULTS


Test-retest reliabilities were highly variable, with most endpoints demonstrating unacceptably low reproducibility. Data reduction confirmed four distinct neuropsychological domains: executive functioning/attention, visuospatial ability, memory, and behavior. Test-retest reliabilities of latent factors improved to acceptable levels for clinical trials. Applicability and utility of our model was demonstrated by homogeneous effect sizes in the reanalyzed efficacy data.
INTERPRETATION


These data demonstrate that single observed endpoints are not appropriate to determine efficacy, partly accounting for the poor test-retest reliability of cognitive outcomes in clinical trials in neurodevelopmental disorders. Recommendations to improve reproducibility are outlined to guide future trial design.",2019,"Data reduction confirmed four distinct neuropsychological domains: executive functioning/attention, visuospatial ability, memory, and behavior.","['Data were analyzed from the STARS clinical trial (n\xa0=\xa0146), a multi-center double-blind placebo-controlled phase II trial of', 'children with neurofibromatosis type 1 (NF1']","['lovastatin', 'placebo']","['distinct neuropsychological domains: executive functioning/attention, visuospatial ability, memory, and behavior']","[{'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027831', 'cui_str': 'Peripheral Neurofibromatosis'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.238086,"Data reduction confirmed four distinct neuropsychological domains: executive functioning/attention, visuospatial ability, memory, and behavior.","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Stephen J C', 'Initials': 'SJC', 'LastName': 'Hearps', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Walsh', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Paltin', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': ""Kids Neuroscience Centre, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Ullrich', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Haebich', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coghill', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Gioia', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cantor', 'Affiliation': 'Department of Preventative Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Tonsgard', 'Affiliation': ""Division of Neurology, The University of Chicago Medicine Comer Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Viskochil', 'Affiliation': 'Department of Genetics, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Celiane', 'Initials': 'C', 'LastName': 'Rey-Casserly', 'Affiliation': ""Center for Neuropsychology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Schorry', 'Affiliation': ""Human Genetics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Ackerson', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Klesse', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fisher', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gutmann', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Tena', 'Initials': 'T', 'LastName': 'Rosser', 'Affiliation': ""Department of Neurology, Children's Hospital of Los Angeles, Los Angeles, California.""}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Packer', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Korf', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Acosta', 'Affiliation': ""Center for Neuroscience and Behavioral Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'North', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of clinical and translational neurology,['10.1002/acn3.50952']
970,31712348,Evaluation of the efficacy of 3D total-body photography with sequential digital dermoscopy in a high-risk melanoma cohort: protocol for a randomised controlled trial.,"INTRODUCTION


Melanoma is Australia's fourth most common cancer. Early detection is fundamental in maximising health outcomes and minimising treatment costs. To date, population-based screening programmes have not been justified in health economic studies. However, a skin surveillance approach targeting high-risk individuals could improve the cost-benefit ratio.
METHODS AND ANALYSIS


This paper describes a 2-year longitudinal randomised controlled trial (RCT) to compare routine clinical care (control) with an intensive skin surveillance programme (intervention) consisting of novel three-dimensional (3D) total-body photography (TBP), sequential digital dermoscopy and melanoma-risk stratification, in a high-risk melanoma cohort. Primary outcomes will evaluate clinical, economic and consumer impact of the intervention. Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed. A health economic analysis using government data repositories will capture healthcare utilisation and costs relating to skin surveillance. Consumer questionnaires will examine intervention acceptability, the psychological impact, and attitudes towards melanoma risk and sun protective behaviour. Secondary outcomes include the development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach. Furthermore, the feasibility of integrating the intervention with teledermatology to enhance specialist care in remote locations will be evaluated. This will be the first RCT to compare a targeted surveillance programme utilising new 3D TBP technology against current routine clinical care for individuals at high risk of melanoma.
ETHICS AND DISSEMINATION


This study has received Human Research Ethics Committee (HREC) approval from both Metro South Health HREC (HREC/17/QPAH/816) and The University of Queensland HREC (2018000074).
TRIAL REGISTRATION NUMBER


ANZCTR12618000267257; Pre-results.",2019,"Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed.",['individuals at high risk of melanoma'],"['3D total-body photography with sequential digital dermoscopy', 'routine clinical care (control) with an intensive skin surveillance programme (intervention) consisting of novel three-dimensional (3D) total-body photography (TBP), sequential digital dermoscopy and melanoma-risk stratification']","['development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach', 'clinical, economic and consumer impact of the intervention', 'rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1449565', 'cui_str': 'Dermoscopy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0150350', 'cui_str': 'Skin surveillance'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0948553', 'cui_str': 'Lesion excision'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",,0.380854,"Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed.","[{'ForeName': 'Clare Amy', 'Initials': 'CA', 'LastName': 'Primiero', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Aideen M', 'Initials': 'AM', 'LastName': 'McInerney-Leo', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Betz-Stablein', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whiteman', 'Affiliation': 'Cancer Control Group, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gordon', 'Affiliation': 'Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Caffery', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Aitken', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eakin', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Osborne', 'Affiliation': 'School of Nursing and Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Centre for Online Health, Centre for Health Services Research, The University of Queensland, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'B Mark', 'Initials': 'BM', 'LastName': 'Smithers', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'H Peter', 'Initials': 'HP', 'LastName': 'Soyer', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia p.soyer@uq.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Finnane', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032969']
971,31719087,Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial.,"INTRODUCTION


Effective approaches to increase engagement in treatment for opioid use disorder (OUD) and reduce the risk of recurrent overdose and death following emergency department (ED) presentation for opioid overdose remain unknown. As such, we aim to compare the effectiveness of behavioural interventions delivered in the ED by certified peer recovery support specialists relative to those delivered by licensed clinical social workers (LCSWs) in promoting OUD treatment uptake and reducing recurrent ED visits for opioid overdose.
METHODS AND ANALYSIS


Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD) (n=650) will be recruited from two EDs in a single healthcare system in Providence, Rhode Island into a two-arm randomised trial with 18 months of follow-up postrandomisation. Eligible participants will be randomly assigned (1:1) in the ED to receive a behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW. The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
ETHICS AND DISSEMINATION


This protocol was approved by the Rhode Island Hospital institutional review board (Approval Number: 212418). Data will be presented at national and international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03684681.",2019,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","['individuals at high risk for opioid overdose', 'Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD', 'Eligible participants']","['behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW', 'emergency department-based peer recovery support intervention', 'behavioural interventions']","['engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}]",,0.120482,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Samuels', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Brinkman', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Dettor', 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Mahoney', 'Affiliation': 'Rhode Island Department of Behavioral Healthcare Developmental Disabilities and Hospitals, Cranston, Rhode Island, USA.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nizami', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': ""O'Toole"", 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Yedinak', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Beaudoin', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA Francesca_Beaudoin@brown.edu.'}]",BMJ open,['10.1136/bmjopen-2019-032052']
972,31719096,"Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D).","INTRODUCTION


Transition from paediatric to adult care is challenging for adolescents and emerging adults (ages 18 to 30 years) with type 1 diabetes (T1D). This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications. However, evidence to guide delivery of transition care is lacking. Given the effectiveness of group education in adult diabetes glycaemic control and improvements in qualitative measures in paediatric diabetes, group education is a potentially feasible and cost-effective alternative for the delivery of transition care. In emerging adults with T1D, we aim to assess the effectiveness of group education visits compared with usual care on HbA1c, T1D-related complications, psychosocial measures and cost-effectiveness after the transfer to adult care.
METHODS AND ANALYSIS


In a multisite, assessor-blinded, randomised, two-arm, parallel-group, superiority trial, 212 adolescents with T1D (ages 17 years) are randomised to 12 months group education versus usual T1D care before transfer to adult care. Visits in the active arm consist of group education sessions followed by usual T1D care visits every 3 months. Primary outcome is change in HbA1c measured at 24 months. Secondary outcomes are delays in establishing adult diabetes care, T1D-related hospitalisations and emergency department visits, severe hypoglycaemia, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, quality of life and cost-effectiveness at 12 and 24 months follow-up. Analysis will be by intention-to-treat. Change in HbA1c will be calculated and compared between arms using differences (95% CI), along with cost-effectiveness analysis. A similar approach will be conducted to examine between-arm differences in secondary outcomes.
ETHICS AND DISSEMINATION


The study was approved by McGill University Health Centre Research Ethics Board (GET-IT/MP-37-2019-4434, version 'Final 1.0 from November 2018). Study results will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03703440.",2019,"This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications.","['adolescents and emerging adults (ages 18 to 30 years) with type 1 diabetes (T1D', 'adolescents with type 1 diabetes during transition from paediatric to adult care', '212 adolescents with T1D (ages 17 years']",['12\u2009months group education versus usual T1D care before transfer to adult care'],"['delays in establishing adult diabetes care, T1D-related hospitalisations and emergency department visits, severe hypoglycaemia, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, quality of life and cost-effectiveness', 'glycaemic control (haemoglobin A1c (HbA1c', 'change in HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1171177', 'cui_str': 'Adult health care'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}]","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",212.0,0.155879,"This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Mok', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire Sainte-Justine, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Québec, Canada.'}, {'ForeName': 'Kaberi', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahme', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hajizadeh', 'Affiliation': 'School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Pediatrics, Nephrology, McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Prevost', 'Affiliation': 'Pediatrics, Endocrinology, McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frei', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Meranda', 'Initials': 'M', 'LastName': 'Nakhla', 'Affiliation': 'Pediatrics, Endocrinology, McGill University Health Centre, Montreal, Québec, Canada meranda.nakhla@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2019-033806']
973,31525122,Cognitive and Affective Responses to Mass-media Based Genetic Risk Information in a Socio-demographically Diverse Sample of Smokers.,"Many individuals receive information about genomics from the mass media. When media reports are about conditions that are considered behavioral, such as smoking, they may negatively affect some health-promoting cognitions. We examined how informing adult smokers about the genetic basis for nicotine addiction influenced smoking-related health cognitions and affect and whether responses varied by socio-demographics or genetics beliefs. We recruited 392 smokers (Mage = 44.5, 52.8% African American, 51.3% no college experience, 66.2% women) from public locations in a mid-sized Midwestern city. They were randomly assigned to read a news article describing either a pharmacy's decision to stop selling tobacco (n = 78) or the discovery of a gene associated with increased risk of nicotine addiction and lung cancer (n = 314). Participants also completed a survey assessing socio-demographics, health cognitions (quit intentions, self-efficacy, response efficacy, perceived risk), affect (worry, anticipated regret), genetic determinism, and other genetics beliefs. ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects. Linear regressions revealed that socio-demographics and genetics beliefs moderated very few effects. This suggests that concerns that mass media-based dissemination of genetic discoveries may have detrimental effects on smoking-related cognitions and affects are likely unwarranted.",2019,ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects.,"['392 smokers (Mage\xa0=\xa044.5, 52.8% African American, 51.3% no college experience, 66.2% women) from public locations in a mid-sized Midwestern city', 'adult smokers', 'a Socio-demographically Diverse Sample of Smokers']",['Cognitive and Affective Responses to Mass-media Based Genetic Risk Information'],"['survey assessing socio-demographics, health cognitions (quit intentions, self-efficacy, response efficacy, perceived risk), affect (worry, anticipated regret), genetic determinism, and other genetics beliefs', 'health cognitions']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024869', 'cui_str': 'Mass Media'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0949313', 'cui_str': 'Genetic Determinism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",392.0,0.032683,ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects.,"[{'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Waters', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ackerman', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Courtney S', 'Initials': 'CS', 'LastName': 'Wheeler', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1664676']
974,31792878,"Oral morphine drops for prompt relief of breathlessness in patients with advanced cancer-a randomized, double blinded, crossover trial of morphine sulfate oral drops vs. morphine hydrochloride drops with ethanol (red morphine drops).","PURPOSE


Episodic breathlessness is frequent in palliative cancer patients. Opioids are the only pharmacological agents with sufficient evidence in treatment. In Denmark, the main recommendation is red morphine drops (RMD), an off-label solution of morphine, ethanol, and red color (cochenille) described since 1893 (Pharmacopoea Danica). In 2015, the Danish Medicines Agency increased focus on off-label medicines and recommended registered morphine drops without ethanol instead. However, our palliative patients told us that RMD was better. For that reason, we conducted a clinical trial to clarify any perceived difference between the two types of drops.
METHODS


We conducted a randomized, double blinded, crossover trial. Patients were asked to perform standardized activity (2-min walk) aiming to provoke breathlessness. Primary endpoint (breathlessness NRS) and secondary endpoints (saturation, pulse, respiratory frequency) were measured before (t = 0) and after test medicine at t = 1, t = 3, t = 5, t = 10, and t = 20 min. After 2-4 days (washout period), the patients repeated the test, receiving the alternative drops in a blinded setup (crossover).
RESULTS


In the first 3 min, the relative drop in breathlessness for morphine drops with ethanol (RMD) was significant more than for morphine drops without ethanol. We found no significant difference in secondary endpoints.
CONCLUSIONS


A conclusion could be that ethanol might facilitate morphine absorption in the mouth. Our results needs further research of opioid absorption in the mouth as well as trials, testing morphine vs. more lipophilic opioids. The RMD drops are cheap, easy to use, and noninvasive and keep the patient independent of health care professionals.",2020,"In the first 3 min, the relative drop in breathlessness for morphine drops with ethanol (RMD) was significant more than for morphine drops without ethanol.","['palliative cancer patients', 'patients with advanced cancer']","['morphine drops without ethanol', 'ethanol', 'morphine drops with ethanol (RMD', 'morphine sulfate oral drops vs. morphine hydrochloride drops with ethanol (red morphine drops', 'morphine, ethanol, and red color (cochenille', 'Oral morphine']","['Primary endpoint (breathlessness NRS) and secondary endpoints (saturation, pulse, respiratory frequency']","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C0991577', 'cui_str': 'Oral drops'}, {'cui': 'C0770901', 'cui_str': 'Morphine hydrochloride'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",,0.392171,"In the first 3 min, the relative drop in breathlessness for morphine drops with ethanol (RMD) was significant more than for morphine drops without ethanol.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Aabom', 'Affiliation': 'Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Vestermarksvej 13.1, DK-4000, Roskilde, Denmark. bimaa@regionsjaelland.dk.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Laier', 'Affiliation': 'Department of Data and Innovation, Region Zealand, Alleen 15, DK-4180, Soroe, Denmark.'}, {'ForeName': 'Poul Lunau', 'Initials': 'PL', 'LastName': 'Christensen', 'Affiliation': 'Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Vestermarksvej 13.1, DK-4000, Roskilde, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Vestermarksvej 13.1, DK-4000, Roskilde, Denmark.'}, {'ForeName': 'May-Britt', 'Initials': 'MB', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Vestermarksvej 13.1, DK-4000, Roskilde, Denmark.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Hedal', 'Affiliation': 'Hospice Zealand, Tonsbergvej 61, DK-4000, Roskilde, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05116-1']
975,31237158,Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART.,"AIMS


In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.
METHODS AND RESULTS


A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67,  p <0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84,  p <0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint ( p =0.976) or major bleeding ( p =0.801).
CONCLUSIONS


Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.",2019,"Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001).","['Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease', '6006 patients with acute coronary syndrome planned for percutaneous coronary intervention', 'patients with acute coronary syndrome undergoing invasive management']","['Radial versus femoral access', 'Bivalirudin versus Heparin', 'unfractionated heparin', 'Bivalirudin', 'bivalirudin', 'bivalirudin or unfractionated heparin', 'bivalirudin/unfractionated heparin']","['death, myocardial infarction or major bleeding', 'lower risk of death, myocardial infarction or major bleeding', 'Baseline risk', 'major bleeding', 'risk of death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",6006.0,0.614289,"Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Völz', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Angerås', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Haraldsson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Sarno', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Grimfärd', 'Affiliation': 'Department of Internal Medicine, Västmanlands Sjukhus, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ulvenstam', 'Affiliation': 'Department of Cardiology, Östersund Hospital, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Sweden.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Hamid', 'Affiliation': 'Department of Cardiology, Mälarsjukhuset, Sweden.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Cardiology, Helsingborg Lasarett, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Danielewicz', 'Affiliation': 'Department of Cardiology, Karlstad Hospital, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eriksson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Scherstén', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Department of Cardiology, Århus University Hospital, Sweden.'}, {'ForeName': 'Pétur', 'Initials': 'P', 'LastName': 'Pétursson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618817217']
976,30776013,"Effect of Navigation Problems, Assessment Location, and a Practice Test on Driving Assessment Performance for People with Alzheimer's Disease.","BACKGROUND


People with Alzheimer's disease may be required to undertake clinical and on-road assessments to determine fitness to drive. The manner in which on-road assessments are conducted with drivers who do and do not have navigational problems may affect the outcome.
OBJECTIVES


Investigate the effect of 1) navigational difficulties, 2) location of assessment (un/familiar area) and assessment order, and 3) undertaking a second assessment (practice), on passing an on-road driving assessment.
METHODS


Forty-three drivers undertook an Occupational Therapy-Driver Assessment Off Road Assessment (OT-DORA) Battery which included the Drive Home Maze Test (DHMT). Participants with/without a history of navigational problems were randomly allocated into three groups: 1) Unfamiliar/then familiar area assessment; 2) Unfamiliar/unfamiliar; 3) familiar/unfamiliar. An on-road assessment protocol was used including over 100 expected behaviors at nominated points along the directed route. For familiar area assessments, the driver self-navigated from their home to shops and services. A pass/fail decision was made for each assessment.
RESULTS


A generalized linear mixed effects model showed neither location, nor practice affected passing the on-road assessment. Participants with navigational problems were six times less likely to pass regardless of route familiarity and direction method, and the DHMT was a significant negative predictor of passing.
CONCLUSION


Drivers with Alzheimer's disease who have navigational problems and are slow to complete the DHMT are unlikely to pass an on-road assessment. However, navigation and maze completion skills may be a proxy for an underlying cognitive skill underpinning driving performance.",2019,"Participants with navigational problems were six times less likely to pass regardless of route familiarity and direction method, and the DHMT was a significant negative predictor of passing.
","['Participants with navigational problems', ""People with Alzheimer's disease"", 'Participants with/without a history of navigational problems', ""People with Alzheimer's Disease"", ""Drivers with Alzheimer's disease who have navigational problems""]","['1) navigational difficulties, 2) location of assessment (un/familiar area) and assessment order, and 3) undertaking a second assessment (practice), on passing an on-road driving assessment', 'Navigation Problems, Assessment Location, and a Practice Test', 'Occupational Therapy-Driver Assessment Off Road Assessment (OT-DORA) Battery which included the Drive Home Maze Test (DHMT', 'Unfamiliar/then familiar area assessment; 2) Unfamiliar/unfamiliar; 3) familiar/unfamiliar']",[],"[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],,0.0498484,"Participants with navigational problems were six times less likely to pass regardless of route familiarity and direction method, and the DHMT was a significant negative predictor of passing.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Unsworth', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Austin Health, Heidelberg West, VIC, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lovell', 'Affiliation': 'Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'Austin Health, Heidelberg West, VIC, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Browne', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Melbourne, VIC, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181069']
977,31230842,Early versus late venous thromboembolism: A secondary analysis of data from the PROPPR trial.,"BACKGROUND


Factors predicting timing of post-traumatic venous thromboembolism (VTE) remain incompletely understood. Because the balance between hemorrhage and thrombosis is dynamic during a patient's hospital course, early and late VTE may be physiologically discrete processes. This secondary analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial aims to explore whether certain risk factors are associated with early versus late VTE.
METHODS


The PROPPR trial investigated post-traumatic resuscitation with platelets, plasma, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. Multinomial regression based on a threshold determined by cubic spline analysis tested the association of clinical variables with early or late VTE, a composite of deep vein thrombosis and pulmonary embolus, adjusting for predetermined confounders.
RESULTS


Of the 87 patients (13%) with VTE, pulmonary embolus was predominant in the first 72 hours. A statistically determined threshold at 12 days corresponded to change in odds of early versus late events. Variables associated with early VTE included plasma transfusion (risk ratio [RR] 1.14; 95% confidence interval, 1.00, 1.30; P = .05), sepsis (RR 0.05; 95% confidence interval, 1.40, 6.64; P = .01), pelvic or femur fracture (RR 2.62; 95% confidence interval, 1.00, 6.90; P = .05). Late VTE was associated with dialysis (RR 7.37; 95% confidence interval, 1.59, 34.14; P = .01), older age (RR 1.02; 95% confidence interval 1.00, 1.04; P = .05), and delayed resuscitation approaching ratios of 1:1:1 among patients randomized to 1:1:2 therapy (RR 2.06; 95% confidence interval, 0.28, 3.83; P = .02). Cyroprecipitate increased risk of early (RR 1.04, 95% confidence interval, 1.00,1.08; P < .03) and late VTE (1.05; 95% confidence interval, 1.01, 1.09; P = .01). Prolonged lagtime (coeffcient 0.06, 95% confidence interval, 0.02, 0.10; P < .01) and time-to-peak thrombin generation (coeffcient 0.04, 95% confidence interval, 0.02, 0.07; P < .01) were associated with increased risk of early VTE.
CONCLUSION


Early and late VTE may differ in their risk factors. Defining temporal trends in VTE may allow for a more individualized approach to thromboprophylaxis.",2019,"Cyroprecipitate increased risk of early (RR 1.04, 95% confidence interval, 1.00,1.08; P < .03) and late VTE (1.05; 95% confidence interval, 1.01, 1.09; P = .01).",[],[],"['Prolonged lagtime', 'sepsis', 'time-to-peak thrombin generation', 'plasma transfusion', 'pelvic or femur fracture', 'platelets, plasma, and red blood cells', 'risk of early VTE', 'late VTE']",[],[],"[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma (procedure)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",,0.456823,"Cyroprecipitate increased risk of early (RR 1.04, 95% confidence interval, 1.00,1.08; P < .03) and late VTE (1.05; 95% confidence interval, 1.01, 1.09; P = .01).","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Myers', 'Affiliation': 'Department of General Surgery, The University of Pittsburgh Medical Center, Pittsburgh, PA. Electronic address: myerssp@upmc.edu.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of General Surgery, The University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Leeper', 'Affiliation': 'Department of General Surgery, The University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Kutcher', 'Affiliation': 'Division of Trauma and Critical Care, The University of Mississippi Medical Center, Jackson, MI.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Pittsburgh Surgical Outcomes Research Center, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, McGovern School of Medicine, Houston, TX.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Trauma, Critical Care and Acute Care Surgery, Department of Surgery, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Cardenas', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, McGovern School of Medicine, Houston, TX.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Department of General Surgery, The University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of General Surgery, The University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgery,['10.1016/j.surg.2019.04.014']
978,31218354,Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54.,"AIMS


In PEGASUS-TIMI 54, ticagrelor significantly reduced the risk of the composite of major adverse cardiovascular (CV) events by 15-16% in stable patients with a prior myocardial infarction (MI) 1-3 years earlier. We report the efficacy and safety in the subpopulation recommended for treatment in the European (EU) label, i.e. treatment with 60 mg b.i.d. initiated up to 2 years from the MI, or within 1 year after stopping previous adenosine diphosphate receptor inhibitor treatment.
METHODS AND RESULTS


Of the 21 162 patients enrolled in PEGASUS-TIMI 54, 10 779 patients were included in the primary analysis for this study, randomized to ticagrelor 60 mg (n = 5388) or matching placebo (n = 5391). The cumulative proportions of patients with events at 36 months were calculated by the Kaplan-Meier (KM) method. The composite of CV death, MI, or stroke occurred less frequently in the ticagrelor group (7.9% KM rate vs. 9.6%), hazard ratio (HR) 0.80 [95% confidence interval (CI) 0.70-0.91; P = 0.001]. Ticagrelor also reduced the risk of all-cause mortality, HR 0.80 (0.67-0.96; P = 0.018). Thrombolysis in myocardial infarction major bleeding was more frequent in the ticagrelor group 2.5% vs. 1.1%; HR 2.36 (1.65-3.39; P < 0.001). The corresponding HR for fatal or intracranial bleeding was 1.17 (0.68-2.01; P = 0.58).
CONCLUSION


In PEGASUS-TIMI 54, treatment with ticagrelor 60 mg as recommended in the EU label, was associated with a relative risk reduction of 20% in CV death, MI, or stroke. Thrombolysis in myocardial infarction major bleeding was increased, but fatal or intracranial bleeding was similar to placebo. There appears to be a favourable benefit-risk ratio for long-term ticagrelor 60 mg in this population.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov NCT01225562.",2019,"TIMI major bleeding was more frequent in the ticagrelor group 2.5% vs 1.1%; HR 2.36 (1.65, 3.39, p < 0.001).","['Patients with Prior Myocardial Infarction in the Approved European label', 'Of the 21,162 patients enrolled in PEGASUS-TIMI 54, 10,779 patients']","['Ticagrelor', 'matching placebo', 'ticagrelor 60', 'ticagrelor']","['cumulative proportions', 'corresponding HR for fatal or intracranial bleeding', 'composite of CV death, MI or stroke', 'fatal or intracranial bleeding', 'TIMI major bleeding', 'efficacy and safety', 'Efficacy and Safety', 'risk of the composite of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",21162.0,0.0694936,"TIMI major bleeding was more frequent in the ticagrelor group 2.5% vs 1.1%; HR 2.36 (1.65, 3.39, p < 0.001).","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Dellborg', 'Affiliation': 'Department of Medicine, University of Gothenburg, Institute of Medicine, Sahlgrenska Academy, Sahlgrenska University Hospital/Östra, Diagnosvägen 11, Gothenburg, Sweden.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'Harvard Medical School, TIMI Study Group, Boston, MA, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'University Paris Diderot, INSERM Unite 1148, Hôptial Bichat, Paris, France.'}, {'ForeName': 'Kyung A', 'Initials': 'KA', 'LastName': 'Im', 'Affiliation': 'Harvard Medical School, TIMI Study Group, Boston, MA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': 'Harvard Medical School, TIMI Study Group, Boston, MA, USA.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Oude Ophuis', 'Affiliation': 'Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Andrezej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': 'University Hospital, Jihlavska, Brno, Czech Republic.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Department of Cardiology, Military Hospital, Budapest, Hungary.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Cardiovascular Division, University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kamensky', 'Affiliation': 'Department of Noninvasive Cardiovascular Diagnostics, Vth Internal Clinic, University Hospital Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ardissino', 'Affiliation': 'Division of Cardiology, Azienda Ospedaliero Universitaria di Parma, Parma, Italy.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Kontny', 'Affiliation': 'Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université Paris 6, ACTION Study Group, INSERM-UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': 'Harvard Medical School, TIMI Study Group, Boston, MA, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': 'Harvard Medical School, TIMI Study Group, Boston, MA, USA.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz020']
979,31231758,A Single Dose of Dietary Nitrate Increases Maximal Knee Extensor Angular Velocity and Power in Healthy Older Men and Women.,"BACKGROUND


Aging results in reductions in maximal muscular strength, speed, and power, which often lead to functional limitations highly predictive of disability, institutionalization, and mortality in elderly adults. This may be partially due to reduced nitric oxide (NO) bioavailability. We, therefore, hypothesized that dietary nitrate (NO3-), a source of NO via the NO3- → nitrite (NO2-) → NO enterosalivary pathway, could increase muscle contractile function in older subjects.
METHODS


Twelve healthy older (age 71 ± 5 years) men and women were studied using a randomized, double-blind, placebo-controlled, crossover design. After fasting overnight, subjects were tested 2 hours after ingesting beetroot juice containing or devoid of 13.4 ± 1.6 mmol NO3-. Plasma NO3- and NO2- and breath NO were measured periodically, and muscle function was determined using isokinetic dynamometry.
RESULTS


N O 3 - ingestion increased (p < .001) plasma NO3-, plasma NO2-, and breath NO by 1,051% ± 433%, 138% ± 149%, and 111% ± 115%, respectively. Maximal velocity of knee extension increased (p < .01) by 10.9% ± 12.1%. Maximal knee extensor power increased (p < .05) by 4.4% ± 7.8%.
CONCLUSIONS


Acute dietary NO3- intake improves maximal knee extensor angular velocity and power in older individuals. These findings may have important implications for this population, in whom diminished muscle function can lead to functional limitations, dependence, and even premature death.",2020,"RESULTS


NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and","['healthy older men and women', 'y) men and women', 'older subjects', 'Twelve healthy older (age 71±5', 'older individuals']","['dietary nitrate', 'dietary nitrate (NO3', 'Acute dietary NO3- intake', 'placebo']","['Plasma NO3- and NO2 and breath NO', 'maximal knee extensor angular velocity and power', 'Maximal knee extensor power', 'maximal knee extensor angular velocity', 'NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and', 'nitric oxide (NO) bioavailability', 'Maximal velocity of knee extension']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",12.0,0.0826662,"RESULTS


NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Coggan', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Hoffman', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Derrick A', 'Initials': 'DA', 'LastName': 'Gray', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Department of Internal Medicine, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Deepak P', 'Initials': 'DP', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Dakkota', 'Initials': 'D', 'LastName': 'Thies', 'Affiliation': 'Department of Radiology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz156']
980,31170542,Comparing Direct Challenge to Penicillin Skin Testing for the Outpatient Evaluation of Penicillin Allergy: A Randomized Controlled Trial.,"BACKGROUND


Direct challenge (DC) may be a safe and effective alternative to penicillin skin testing (PST) in low-risk patients.
OBJECTIVE


To complete a prospective, randomized, controlled trial comparing PST followed by a challenge to amoxicillin versus a 2-step DC to amoxicillin without preceding skin testing in a predefined low-risk patient population.
METHODS


Penicillin allergy histories were reviewed in patients presenting to an outpatient allergy/immunology practice from April 2018 to August 2018. Patients 5 years or older with a cutaneous-only or unknown reaction (>1 year ago for those aged 5-17 years, >10 years ago for those 18 years or older) were randomized 1:1 to PST or 2-step DC. All children younger than 5 years underwent DC, and patients with extracutaneous reaction histories underwent PST. All groups were monitored 30 minutes after administration of amoxicillin.
RESULTS


Penicillin allergy was reported in 363 of 2465 (14.7%) patients, of which 185 consented to further evaluation. Thirteen patients younger than 5 years underwent DC; all were negative. Thirteen patients with angioedema and/or extracutaneous symptoms underwent PST; 2 of 13 patients had positive PST result. A total of 159 patients were randomized to DC (49.7%) or PST (50.3%). PST result was negative in 70 of 80 (87.5%) patients. All 70 patients had a negative amoxicillin challenge. DC was negative in 76 of 79 (96.2%) patients; positive DC reactions were minor. Average time for patients undergoing PST was 72.7 ± 5.3 minutes and for patients undergoing DC was 66.7 ± 4.8 minutes.
CONCLUSIONS


In low-risk patients, DC provided a safe and effective alternative to PST in delabeling penicillin allergy. Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.",2019,"Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.","['Thirteen patients with angioedema and/or extracutaneous symptoms underwent PST; 2 of 13 patients had positive PST result', '159 patients', 'a predefined low-risk patient population', 'All children younger than 5 years underwent DC, and patients with extracutaneous reaction histories underwent PST', 'All 70 patients had a negative amoxicillin challenge', 'Thirteen patients younger than 5 years underwent', 'low-risk patients', 'Penicillin allergy histories were reviewed in patients presenting to an outpatient allergy/immunology practice from April 2018 to August 2018', 'Patients 5 years or older with a cutaneous-only or unknown reaction (>1 year ago for those aged 5-17 years, >10 years ago for those 18 years or older']","['Penicillin Skin Testing', 'amoxicillin', 'penicillin skin testing (PST', 'PST', 'PST or 2-step DC', 'DC']","['Average time', 'positive DC reactions']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0030824', 'cui_str': 'Allergy to penicillin (disorder)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",159.0,0.0506061,"Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.","[{'ForeName': 'S Shahzad', 'Initials': 'SS', 'LastName': 'Mustafa', 'Affiliation': 'Rochester Regional Health, Rochester, NY; University of Rochester School of Medicine and Dentistry, Rochester, NY. Electronic address: shahzad.mustafa@rochesterregional.org.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Conn', 'Affiliation': 'Wegmans School of Pharmacy, St John Fisher College, Rochester, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ramsey', 'Affiliation': 'Rochester Regional Health, Rochester, NY; University of Rochester School of Medicine and Dentistry, Rochester, NY. Electronic address: allison.ramsey@rochesterregional.org.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.05.037']
981,31228006,"Comparison between hemodynamic effects of propofol and thiopental during general anesthesia induction with remifentanil infusion: a double-blind, age-stratified, randomized study.","PURPOSE


Propofol is commonly used with remifentanil for induction of general anesthesia (GA); however, it often leads to hypotension. Intraoperative hypotension is associated with postoperative adverse events. By contrast, thiopental has less negative inotropic effects on hemodynamics compared to propofol, which could be suitable to prevent hypotension during GA induction. In the present age-stratified, randomized, assessor-blinded study, using the ClearSight ®  system, we compared the hemodynamic effects of propofol and thiopental during GA induction under remifentanil infusion in non-cardiac surgery.
METHODS


Patients were divided into young (20-40 year), middle (41-70 year), and elderly (> 70 year) groups (n = 20, each group). General anesthesia was induced with remifentanil 0.3 μg/kg/min, followed by propofol (2.0, 1.5, and 1.2 mg/kg) or thiopental (5.0, 4.0, and 3.0 mg/kg) in the young, middle, and elderly groups, respectively. The primary outcome was the difference in the decrease in mean arterial blood pressure between patients receiving propofol and thiopental in each age group. The secondary outcomes included other hemodynamic parameters and minimal bispectral index values measured up to 10 min after tracheal intubation.
RESULTS


The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
CONCLUSIONS


Thiopental is a more suitable agent than propofol for avoiding hypotension during GA induction under remifentanil infusion in the middle and elderly patients.",2019,"The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
","['Patients were divided into young (20-40\xa0year), middle (41-70\xa0year), and elderly (>\u200970\xa0year) groups (n\u2009=\u200920, each group', 'middle and elderly patients']","['remifentanil infusion', 'remifentanil 0.3\xa0μg/kg/min, followed by propofol', 'propofol and thiopental', 'propofol and thiopental during GA induction under remifentanil infusion', 'propofol', 'remifentanil', 'thiopental', 'Propofol', 'Thiopental']","['mean arterial blood pressure', 'Intraoperative hypotension', 'hemodynamic parameters and minimal bispectral index values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0620839,"The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hino', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan. m1165192@yahoo.co.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kihara', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Tsujikawa', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}]",Journal of anesthesia,['10.1007/s00540-019-02657-x']
982,32410362,Combination of oral methotrexate and oral mini-pulse dexamethasone vs either agent alone in vitiligo treatment with follow up by dermoscope.,"This study aimed to compare the efficacy and safety of oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone alone and in combination in the treatment of vitiligo. A total of 42 patients with vitiligo were included in the study. The patients were treated for three months and randomly assigned into three groups including 14 patients each: group A received oral MTX, group B received OMP dexamethasone, and group C received a combination of both. Follow-up was performed using digital photographs, Vitiligo European Task Force score, and dermoscopy. Disease extension significantly decreased in group C compared with that in groups A (P < .001) and B (P < .05). The frequency of intralesional pigmentation significantly increased (P < .05) in groups A and C and decreased (P < .05) in group B posttreatment noted using a dermoscope. Moreover, the frequency of micro-Koebner's phenomenon and starburst pattern significantly decreased (P < .05) in groups B and C and that of tapioca sago in group C only posttreatment.",2020,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"['42 patients with vitiligo were included in the study', 'vitiligo']","['oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone', 'oral methotrexate and oral mini-pulse dexamethasone', 'oral MTX', 'OMP dexamethasone']","[""frequency of micro-Koebner's phenomenon and starburst pattern"", 'efficacy and safety', 'Disease extension', 'frequency of intralesional pigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0263367', 'cui_str': 'Köbner phenomenon'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",42.0,0.0246827,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"[{'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'ElGhareeb', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Metwalli', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'AbdelMoneim', 'Affiliation': 'Resident Dermatologist, Alhaud Almarsoud hospital, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13586']
983,31184506,Lower Tear Meniscus Height Measurements Using Keratography and Swept-Source Optical Coherence Tomography and Effect of Fluorescein Instillation Methods.,"Purpose : The first aim of this study was to compare inferior tear meniscus height (TMH) measured by keratography and swept-source optical coherence tomography (OCT). Effect of locations of fluorescein instillation and subjects' subjective sensation, and the TMH results were also investigated. Methods : Forty-one eyes from 41 healthy adults had TMH randomly measured by keratography (K5M, Oculus, Germany) and swept-source OCT (Casia SS-1000, Tomey Corp, Japan) at baseline, followed by touching either the inferior bulbar or inferior palpebral conjunctiva, randomly assigned, with a moistened fluorescein strip. Two-way analysis of variance (ANOVA) was used to compare TMH obtained from the two devices and three measurement conditions. Subjective sensation of conjunctival touch was obtained through a 4-point scale with zero representing no sensation, and one to three representing ocular sensation in an ascending order. Results : Two-way ANOVA revealed no significant difference in TMH between keratography and swept-source OCT (Factor (devices): F = 0.579,  p  = .451) while there was a significant difference among fluorescein instillations (Factor (conditions): F = 10.146,  p  < .001). Baseline TMH was around 0.25 mm, and increased to around 0.28 mm after instillation of fluorescein sodium. Ocular sensation was similar between the two conjunctival touch, and TMH was not significantly associated with ocular sensation. Conclusions : Keratography and swept-source OCT provided similar TMH results. Applying fluorescein sodium through moistened fluorescein strip could over-estimate TMH by around 0.03 mm. Applying moistened fluorescein strip at bulbar or palpebral conjunctival led to similar subjective sensations and did not affect TMH measurement.",2019,Applying moistened fluorescein strip at bulbar or palpebral conjunctival led to similar subjective sensations and did not affect TMH measurement.,['41 healthy adults'],"['fluorescein instillation', 'Keratography and swept-source OCT', 'fluorescein sodium', 'fluorescein sodium through moistened fluorescein strip', 'keratography and swept-source optical coherence tomography (OCT']","['inferior tear meniscus height (TMH', 'Subjective sensation of conjunctival touch', 'Ocular sensation', 'Lower Tear Meniscus Height Measurements', 'Baseline TMH', 'TMH']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0147866', 'cui_str': 'fluorescein sodium'}, {'cui': 'C0493031', 'cui_str': 'Fluorescein strip (physical object)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C1828397', 'cui_str': 'Low marginal tear strip'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",41.0,0.0283826,Applying moistened fluorescein strip at bulbar or palpebral conjunctival led to similar subjective sensations and did not affect TMH measurement.,"[{'ForeName': 'Andrew Kc', 'Initials': 'AK', 'LastName': 'Lam', 'Affiliation': 'Laboratory of Experimental Optometry, School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Shirley Ky', 'Initials': 'SK', 'LastName': 'Tai', 'Affiliation': 'Laboratory of Experimental Optometry, School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Jacky Kt', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'Laboratory of Experimental Optometry, School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Raymond Wc', 'Initials': 'RW', 'LastName': 'Ng', 'Affiliation': 'Laboratory of Experimental Optometry, School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Current eye research,['10.1080/02713683.2019.1629598']
984,31795875,Bilateral Transcranial Direct Stimulation Over the Primary Motor Cortex Alters Motor Modularity of Multiple Muscles.,"Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has been demonstrated to modulate the motor performance of both healthy individuals and patients with neuromuscular disorders. However, the effect of tDCS on motor control of multiple muscles, which is a prerequisite to change in motor performance, is currently unknown. Using dimensionality reduction analysis, we investigated whether bilateral tDCS over M1 modulates the coordinated activity of 12 muscles. Fifteen healthy men participated in this randomized, double-blind crossover study. Each participant received a 20-min sham and 2-mA stimulation bilaterally over M1 (anode on the right M1 and cathode on the left M1), with a minimum washout period of 4 days. Muscle activation and end-point kinematics were evaluated during a task where participants reached out to a marked target with non-dominant hand as fast as possible, before and immediately after tDCS application. We found decreased similarity in motor modularity and significant changes in muscle activation in a specific motor module, particularly when reaching out to a target placed within arm's length and improved smoothness index of movement only following 2-mA stimulation. These findings indicate that clinicians and researchers need to consider the simultaneous effect of bilateral tDCS over M1 on multiple muscles when they establish tDCS protocol to change in motor performance of patients with neuromuscular deficits.",2020,"We found decreased similarity in motor modularity and significant changes in muscle activation in a specific motor module, particularly when reaching out to a target placed within arm's length and improved smoothness index of movement only following 2-mA stimulation.","['healthy individuals and patients with neuromuscular disorders', 'patients with neuromuscular deficits', 'Fifteen healthy men']","['20-min sham and 2-mA stimulation bilaterally over M1 (anode on the right M1 and cathode on the left M1', 'tDCS', 'Transcranial direct current stimulation (tDCS', 'Bilateral Transcranial Direct Stimulation']","['Muscle activation and end-point kinematics', 'muscle activation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027868', 'cui_str': 'Neuromuscular Diseases'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",15.0,0.0448022,"We found decreased similarity in motor modularity and significant changes in muscle activation in a specific motor module, particularly when reaching out to a target placed within arm's length and improved smoothness index of movement only following 2-mA stimulation.","[{'ForeName': 'JaeHyuk', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}]",Journal of motor behavior,['10.1080/00222895.2019.1646206']
985,30198380,Five weeks of immersive reminiscence therapy improves autobiographical memory in Alzheimer's disease.,"We examined the effects of a new Immersive Reminiscence Therapy (IRT) programme on cognitive function, including autobiographical memory, in a sample Alzheimer's disease (AD) patients. A total of 43 AD patients with mild to moderate disease severity were randomly assigned to either an intervention group (n = 22, MMMSE = 20.77), or a control group (n = 21, MMMSE = 19.24). The intervention group received one weekly group-based session of IRT for five weeks in an authentic 1950s style museum environment, matching the time of the participants' youth. IRT included semi-structured conversations about the past. The control group received standard care. We assessed performance on cognitive function and autobiographical memory at baseline and post-intervention. Five weeks of IRT enhanced subsequent autobiographical memory performance, when participants were cued by concrete objects dated to their youth. Object-cued memories reported post intervention included a significantly higher degree of episodic details and higher word counts. The intervention showed no effect on the Autobiographical Memory Interview or word-cued recall. Global cognitive function and semantic autobiographical memory performance increased across time for both groups. Our findings demonstrate that immersion into a setting, rich on concrete cues dated to the participants' youth can improve autobiographical remembering.",2019,Global cognitive function and semantic autobiographical memory performance increased across time for both groups.,"[""sample Alzheimer's disease (AD) patients"", '43 AD patients with mild to moderate disease severity', ""Alzheimer's disease""]","['one weekly group-based session of IRT', 'IRT', 'immersive reminiscence therapy', 'new Immersive Reminiscence Therapy (IRT) programme', 'standard care']","['cognitive function, including autobiographical memory', 'Autobiographical Memory Interview or word-cued recall', 'autobiographical remembering', 'Global cognitive function and semantic autobiographical memory performance', 'cognitive function and autobiographical memory', 'degree of episodic details and higher word counts', 'autobiographical memory', 'subsequent autobiographical memory performance']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150321', 'cui_str': 'Rt - reminiscence therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview (assessment scale)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",43.0,0.0417843,Global cognitive function and semantic autobiographical memory performance increased across time for both groups.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kirk', 'Affiliation': 'a Department of Psychology and Behavioural Sciences , Aarhus University , Aarhus C , Denmark.'}, {'ForeName': 'Katrine Willemoes', 'Initials': 'KW', 'LastName': 'Rasmussen', 'Affiliation': 'a Department of Psychology and Behavioural Sciences , Aarhus University , Aarhus C , Denmark.'}, {'ForeName': 'Susanne Bollerup', 'Initials': 'SB', 'LastName': 'Overgaard', 'Affiliation': 'a Department of Psychology and Behavioural Sciences , Aarhus University , Aarhus C , Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Berntsen', 'Affiliation': 'a Department of Psychology and Behavioural Sciences , Aarhus University , Aarhus C , Denmark.'}]","Memory (Hove, England)",['10.1080/09658211.2018.1515960']
986,31790279,Impact of resistance training program configuration on the circulating brain-derived neurotrophic factor response.,"This study examined the acute and resting changes of brain-derived neurotrophic factor (BDNF) and inteleukin-6 (IL-6) and if changes in these biomarkers were correlated during resistance training (RT). Fifteen men with ≥2 years of RT experience (age: 23 ± 3 years, body mass: 84.4 ± 12.3 kg) participated. Subjects performed RT 3×/week for 6 weeks in either a high-repetition (HR;  n  = 8) or low-repetition (LR;  n  = 7) group. Protocols during week 1 were HR - Monday: 4 (sets) × 12 (repetitions) at 60% of 1-repetition maximum, Wednesday: 4 × 10 at 65%, Friday: 5 × 8 at 70%; LR - Monday: 8 × 6 at 75%, Wednesday 9 × 4 at 80%, Friday: 10 × 2 at 85%. Total volume was equated for the 6 weeks but not for individual sessions. Greater volume and intensity were performed in LR versus HR ( p  < 0.01) on Mondays. Plasma was collected immediately before and after exercise of the Monday session. There were no significant interactions or main effects for BDNF ( p  > 0.05). There was a moderate between-group effect size (0.57) in favor of LR in week 6, suggesting a potentially greater acute increase in BDNF in LR versus HR. For IL-6, a statistically significant main effect was observed for training ( p  < 0.0001), showing an acute increase in IL-6 in both weeks ( p  < 0.01); however, no other 3-way or 2-way interactions existed ( p  > 0.05). A minimum volume threshold of RT may be needed to induce acute elevations in BDNF.  Novelty  A minimum RT volume threshold may be needed to elicit BDNF. A close proximity to failure may be needed to elicit BDNF. BDNF and IL-6 did not correlate.",2020,"For IL-6, a statistically significant main effect was observed for training (p<0.0001), showing an acute increase in IL-6 in both weeks (p<0.01), however, no other three-way or two-way interactions existed (p>0.05).","['Fifteen men with ≥2yrs of RT experience (age: 23±3yrs, body mass: 84.4±12.3kg) participated']",['Friday'],"['Circulating Brain-Derived Neurotrophic Factor Response', 'Greater volume and intensity', 'BDNF and IL-6', 'acute increase in IL-6', 'Novelty •', 'Total volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0585029', 'cui_str': 'Friday (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0296483,"For IL-6, a statistically significant main effect was observed for training (p<0.0001), showing an acute increase in IL-6 in both weeks (p<0.01), however, no other three-way or two-way interactions existed (p>0.05).","[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Quiles', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Klemp', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Dolan', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Chun-Jung', 'Initials': 'CJ', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Andy V', 'Initials': 'AV', 'LastName': 'Khamoui', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Trexler', 'Affiliation': 'Stronger By Science, LLC, Raleigh, NC 27604, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Zourdos', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0419']
987,31203109,Parental gentle encouragement promotes shy toddlers' regulation in social contexts.,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period. The current study used a sample of 55 temperamentally shy toddlers (21-24 months old) to examine toddler regulation in novel social contexts in relation to parental gentle encouragement to engage. Contexts included low-threat social novelty (i.e., a clown and puppets) and moderately threatening social novelty (i.e., strangers). Using an experimental design, parents were randomly assigned to provide behaviors thought to represent gentle encouragement: warm responsiveness to toddler fear and encouragement of toddler autonomy, prompt to engage, both warmth and prompt, or remaining uninvolved (no-encouragement control). Relative to toddlers in the no-encouragement control condition, toddlers whose parents were instructed to provide warmth showed less fear and more engagement in moderately threatening social contexts, and toddlers whose parents were instructed to provide both warmth and prompts showed greater suppression of respiratory sinus arrhythmia in low-threat social contexts. Findings suggest that parental gentle encouragement may promote regulated responses in social contexts in shy toddlers. Encouragement of toddler autonomy and warm responsiveness to toddlers in particular may help shy toddlers to engage with, rather than withdraw from, new people.",2019,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period.",['sample of 55 temperamentally shy toddlers (21-24\u202fmonths old'],"['gentle encouragement: warm responsiveness to toddler fear and encouragement of toddler autonomy, prompt to engage, both warmth and prompt, or remaining uninvolved (no-encouragement control', 'Parental gentle encouragement']","['low-threat social novelty', 'suppression of respiratory sinus arrhythmia']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557869', 'cui_str': 'Introvert (finding)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}]",55.0,0.0139952,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period.","[{'ForeName': 'Jessica Stoltzfus', 'Initials': 'JS', 'LastName': 'Grady', 'Affiliation': 'Department of Psychology, University of the Pacific, Stockton, CA 95211, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.05.008']
988,31215092,Effect of vitamin D supplementation on total and free 25 hydroxyvitamin D and parathyroid hormone. An analysis of two randomized controlled trials.,"BACKGROUND


It is questionable as to whether total serum 25 hydroxyvitamin D (T25D) levels are lower in African Americans. We measured serum T25D, free 25hydroxyvitamin D (F25D) and serum parathyroid hormone (PTH) in African American and Caucasian women and studied the effect of vitamin D dosing to determine if differences by race or age occur.
METHODS


Healthy young and older Caucasian and African American women who were vitamin D insufficient were randomized in two clinical trials to escalating daily doses of vitamin D from 400 to 4800 IU and placebo for 12 months.
RESULTS


Baseline F25D and T25D were significantly lower in young but not older African American compared to Caucasian women. At baseline, the rate of change, or slope, in F25D with T25D was significantly greater in younger women than in older women, but difference in the rate of change in F25D with T25D is similar in African American and Caucasian women. After vitamin D supplementation, there was an increase in F25D, and the dose response was not significantly different by age or race. The ratio of F25D/T25D decreased in all groups once T25D exceeded ~60 nmol L -1  . There was a progressive decrease in serum PTH with increasing vitamin D doses and the per cent change was similar for F25D and T25D.
CONCLUSION


Serum F25D and T25D are lower in younger African American women, and since dietary vitamin D is similar in the groups, it is likely that the cause of low serum 25OHD in African American women is due to reduced UV exposure and reduced skin production of vitamin D.",2019,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION


","['African Americans', 'African American and Caucasian women', 'Healthy young and older Caucasian and African American women who were vitamin D insufficient', 'African American women', 'younger African American women']","['vitamin D', 'vitamin D supplementation', 'Vitamin D Supplementation', 'total serum 25 hydroxyvitamin D', 'vitamin D from 400 IU - 4800IU and placebo']","['F25D, and the dose response', 'Baseline F25D and T25D', 'T25D) levels', 'serum T25D, free 25hydroxyvitamin D (F25D), and serum parathyroid hormone (PTH', 'Total and Free 25 Hydroxyvitamin D and Parathyroid Hormone', 'serum PTH', 'ratio of F25D/T25D', 'Serum F25D and T25D', 'rate of change in F25D with T25D']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.198549,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION


","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gallagher', 'Affiliation': 'Bone Metabolism, Department Endocrinology, Creighton University School of Medicine, Omaha, NE, USA.'}]",Journal of internal medicine,['10.1111/joim.12950']
989,31782347,Promoting Information Communication Technology Adoption and Acceptance for Aging-in-Place: A Randomized Controlled Trial.,"The prevailing digital divide along with barriers to information communication technology (ICT) adoption among older adults is well elucidated. To contribute evidence on ICT education, a 2-year randomized controlled trial verified the long-term effect of a novel individualized ICT training program for older adults in demographic cohorts who are known to underutilize ICT ( n  = 42 in the training and  n  = 43 in a control group). Mixed-model repeated measures analysis of data was conducted from baseline and 6-month intervals ( df  = 4, 1) post training. Older adults in the training group engaged in a wide range of leisure ( p  = .03), health management ( p  = .006), and instrumental activities of daily living ( p  = .02) significantly more than those in the control group. They also reported significantly enhanced technology acceptance and sustained sense of independence in key ICT-based activities. The study supports the implementation of one-on-one ICT training programs to promote access and utilization of digital resources for aging-in-place.",2019,"Older adults in the training group engaged in a wide range of leisure ( p  = .03), health management ( p  = .006), and instrumental activities of daily living ( p  = .02) significantly more than those in the control group.","['Older adults', 'older adults', 'older adults in demographic cohorts who are known to underutilize ICT ( n  = 42 in the training and  n  = 43 in a control group']",['novel individualized ICT training program'],"['health management', 'instrumental activities of daily living']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}]",,0.0566291,"Older adults in the training group engaged in a wide range of leisure ( p  = .03), health management ( p  = .006), and instrumental activities of daily living ( p  = .02) significantly more than those in the control group.","[{'ForeName': 'Sajay', 'Initials': 'S', 'LastName': 'Arthanat', 'Affiliation': 'University of New Hampshire, Durham, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464819891045']
990,30785660,Effects of basal insulin glargine and omega-3 on lower limb arterial disease outcome in patients with dysglycaemia: An analysis of the Outcome Reduction with an Initial Glargine INtervention (ORIGIN) trial.,"The impact of insulin or omega-3 supplements on the incidence and progression of peripheral artery disease (PAD) in patients with dysglycaemia has not been well studied. The Outcome Reduction with an Initial Glargine INtervention (ORIGIN) trial randomized participants with dysglycaemia and cardiovascular risk factors to titrated insulin glargine vs standard care, and to either 1 g of omega-3 per day or placebo. We assessed incident PAD, defined as the composite of either asymptomatic or symptomatic PAD according to the randomized interventions in the 11 119 ORIGIN participants whose baseline ankle-brachial index (ABI) was >0.9 (no PAD), and PAD progression in the 971 ORIGIN participants whose baseline ABI was ≤0.9. Hazard ratios (HR) were adjusted for confounders. During a 6.2-year follow-up period, allocation to insulin glargine vs standard care had a neutral effect on the composite of PAD incidence (HR, 0.99; 95% CI, 0.86-1.15) and progression (HR, 0.88; 95% CI, 0.63-1.22). Similar findings were noted for allocation to omega-3 vs placebo for PAD incidence (HR, 1.02; 95% CI, 0.89-1.18) and progression (HR, 0.93; 95% CI, 0.67-1.28). In this large study, neither insulin glargine nor omega-3 affected the incidence or progression of PAD.",2019,"Similar findings were noted for allocation to omega-3 vs placebo for PAD incidence (HR, 1.02; 95% CI, 0.89-1.18) and progression (HR, 0.93; 95% CI, 0.67-1.28).",['patients with dysglycaemia'],"['basal insulin glargine and omega-3', 'insulin or omega-3 supplements', 'Initial Glargine INtervention', 'insulin glargine', 'titrated insulin glargine vs standard care, and to either 1 g of omega-3 per day or placebo']","['composite of PAD incidence', 'incidence or progression of PAD', 'lower limb arterial disease outcome', 'incidence and progression of peripheral artery disease (PAD', 'Hazard ratios (HR', 'PAD progression', 'incident PAD, defined as the composite of either asymptomatic or symptomatic PAD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery (disorder)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",11119.0,0.261148,"Similar findings were noted for allocation to omega-3 vs placebo for PAD incidence (HR, 1.02; 95% CI, 0.89-1.18) and progression (HR, 0.93; 95% CI, 0.67-1.28).","[{'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Department of Cardiology, Institut Universitaire de Cardiologie et Pneumologie de Québec-Université Laval, Québec City, Canada.'}, {'ForeName': 'Hyejung', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Population Health Research Institute, Hamilton General Hospital, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bogaty', 'Affiliation': 'Department of Cardiology, Institut Universitaire de Cardiologie et Pneumologie de Québec-Université Laval, Québec City, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, Hamilton General Hospital, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton General Hospital, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton General Hospital, McMaster University, Hamilton, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13674']
991,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
992,30273708,Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis.,"AIMS


We assessed costs and cost-effectiveness of implementing Fit Body and Soul (FBAS), a church-based 18-session lifestyle education intervention for African Americans.
METHODS


We calculated incremental cost-effectiveness ratios (ICER) using data from a cluster randomized controlled trial comparing FBAS with health education (HE) among 604 overweight participants in 20 churches. The ICER was the adjusted difference in costs to deliver FBAS versus HE over the difference in weight change (kilograms [kg]) at one-year follow-up. Costs included those incurred for participant identification and program implementation. We fitted linear mixed-effects regression models, accounting for clustering of participants within churches and for age, sex, and educational attainment. We repeated these analyses for secondary outcomes (waist circumference [cm], physical activity [MET], glucose, blood pressure, and quality of life).
RESULTS


Per-person intervention cost of FBAS was $50.39 more than HE ($442.22 vs. $391.83 per-person), and adjusted differences in weight change (1.9 kg [95% CI: 1.0 to 2.8]) and waist circumference (2.4 cm [95% CI: 1.3 to 3.4]) were both significant. FBAS did not result in statistically significant differences in physical activity, glucose, blood pressures, or quality of life. We estimated that compared to HE, FBAS costs an additional $26.52 per kg weight lost and $21.00 per cm reduction in waist circumference.
CONCLUSIONS


For a modest increase in cost, FBAS led to greater weight and waist reductions among African Americans in a church setting. ClinicalTrials.gov Identifier NCT01730196.",2018,"For a modest increase in cost, FBAS led to greater weight and waist reductions among African Americans in a church setting.","['604 overweight participants in 20 churches', 'African Americans', 'participants within churches and for age, sex, and educational attainment']","['implementing Fit Body and Soul (FBAS), a church-based 18-session lifestyle education intervention', 'faith-based lifestyle intervention', 'FBAS', 'FBAS with health education (HE']","['costs and cost-effectiveness', 'waist circumference', 'incremental cost-effectiveness ratios (ICER', 'physical activity, glucose, blood pressures, or quality of life', 'FBAS', 'weight change', 'Cost-effectiveness', 'cost, FBAS', 'secondary outcomes (waist circumference [cm], physical activity [MET], glucose, blood pressure, and quality of life']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018701'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034380'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",604.0,0.199943,"For a modest increase in cost, FBAS led to greater weight and waist reductions among African Americans in a church setting.","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Rhodes', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, 1518 Clifton Rd NE, Atlanta, GA 30322, United States. Electronic address: elizabeth.christie.rhodes@emory.edu.'}, {'ForeName': 'Eeshwar K', 'Initials': 'EK', 'LastName': 'Chandrasekar', 'Affiliation': 'Emory University School of Medicine, 100 Woodruff Circle, Atlanta, GA 30322, United States. Electronic address: eeshwar.chandrasekar@emory.edu.'}, {'ForeName': 'Shivani A', 'Initials': 'SA', 'LastName': 'Patel', 'Affiliation': 'Hubert Department of Global Health and Emory Global Diabetes Research Center, Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: s.a.patel@emory.edu.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Hubert Department of Global Health and Emory Global Diabetes Research Center, Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: knaraya@emory.edu.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Joshua', 'Affiliation': 'College of Nursing, Augusta University, 987 St. Sebastian Way, Augusta, GA 30912, United States. Electronic address: tjoshua@augusta.edu.'}, {'ForeName': 'Lovoria B', 'Initials': 'LB', 'LastName': 'Williams', 'Affiliation': 'College of Nursing, Augusta University, 987 St. Sebastian Way, Augusta, GA 30912, United States. Electronic address: lwilliams@augusta.edu.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Marion', 'Affiliation': 'College of Nursing, Augusta University, 987 St. Sebastian Way, Augusta, GA 30912, United States. Electronic address: lumarion@augusta.edu.'}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Hubert Department of Global Health and Emory Global Diabetes Research Center, Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: mkali@emory.edu.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2018.09.016']
993,30088226,The Effect of Counseling on Breast Cancer Awareness in Rural Iranian Women: a Randomized Controlled Clinical Trial.,"In a community such as Iran where late presentation is predominant and the majority of breast cancer patients are diagnosed at advanced stages of the disease, there is an urgent need for improving the level of awareness about breast cancer and early detection measures. Given that rural residents are at higher risk for late diagnosis of breast cancer because they have less education, income, and access to advanced screening technologies, this study was conducted to determine the effect of counseling on breast cancer awareness of rural Iranian women. This randomized clinical trial was conducted on 60 rural women from the Abish Ahmad area in northwestern Iran in 2017. The randomized cluster method was used for sampling. From 20 rural health houses and centers, about one third were selected randomly. From the six selected clusters, three were randomly allocated as the control group and three as the intervention group. Using convenience sampling, 30 women between the ages of 40 and 69 were selected from the control group and 30 from the intervention group. The intervention group attended six group counseling sessions. Data was gathered using a demographic and obstetrical information questionnaire and breast cancer awareness measures. The chi-square, independent t test and ANCOVA by controlling for the baseline scores were used to analyze the data. After counseling, the mean knowledge about breast cancer score was significantly higher in the intervention group than in the control group (adjusted mean difference, 17.02; confidence interval (CI) 95%, 15.44 to 18.59; p < 0.001). The mean barriers to breast cancer screening score showed a significant decrease in the intervention group compared to the control group (AMD, - 1.74; 95% CI - 3.12 to - 0.36, p < 0.001). After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08). Group counseling had a significant effect on enhancing breast cancer awareness of rural Iranian women, except for confidence about noticing breast changes.",2019,"After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08).","['Rural Iranian Women', '60 rural women from the Abish Ahmad area in northwestern Iran in 2017', '30 women between the ages of 40 and 69 were selected from the control group and 30 from the intervention group', 'rural Iranian women', 'From 20 rural health houses and centers, about one third were selected randomly']",[],"['enhancing breast cancer awareness', 'mean barriers to breast cancer screening score', 'frequency of breast self-exam', 'mean knowledge about breast cancer score', 'Breast Cancer Awareness']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035959'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",30.0,0.0471122,"After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Alizadeh Sabeg', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran. rnourizadeh@gmail.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Poursharifi', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1411-z']
994,30132265,The Effect of Fatigue-Related Education on Pediatric Oncology Patients' Fatigue and Quality of Life.,"The identification of cancer-related fatigue as a clinical problem in pediatric oncology is an important phenomenon, and there are limited number of studies about raising the awareness of pediatric oncology patients and their parents. Fatigue-related education for patients and their parents before and during cancer treatment reduces the fatigue levels of patients. This study aims to analyze the effect of fatigue-related education for pediatric oncology patients aged 7-12 and their parents on their fatigue and quality of life. This study was conducted with 80 children with cancer and their parents who were assigned to either the control group (n = 40) or the experimental group (n = 40). The experimental group received a fatigue-related educational program. The data were collected three times: prior to the program, 3 months later, and 6 months afterwards. Multidimensional variance analysis, the Bonferroni adjusted t test and regression analysis were used to analyze the data. A significant difference was found among the experimental and the control group for total mean scores and the mean scores of subdimensions of the Scale for the Assessment of Fatigue-Child Form in terms of the interactions of group, time, and group*time (p < 0.05). Significant differences were found among the experimental and control groups' mean scores on the Scale for the Quality of Life-Child and Parents Form in terms of the interactions of group, time, and group*time (p < 0.05). Fatigue-related education is an effective education model as a way to reduce fatigue and increase the quality of life of children with cancer. The use of fatigue-related education by nurses in pediatric oncology clinics will have positive effects on children and their parents.",2019,"Significant differences were found among the experimental and control groups' mean scores on the Scale for the Quality of Life-Child and Parents Form in terms of the interactions of group, time, and group*time (p < 0.05).","['children and their parents', '80 children with cancer and their parents who were assigned to either the control group (n\u2009=\u200940) or the experimental group (n\u2009=\u200940', 'Pediatric Oncology Patients', 'pediatric oncology patients aged 7-12 and their parents on their', 'children with cancer']","['Fatigue-Related Education', 'fatigue-related educational program']","['Fatigue-related education', 'fatigue and quality of life', 'fatigue levels', 'Fatigue and Quality of Life', 'total mean scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0207193,"Significant differences were found among the experimental and control groups' mean scores on the Scale for the Quality of Life-Child and Parents Form in terms of the interactions of group, time, and group*time (p < 0.05).","[{'ForeName': 'Aslı Akdeniz', 'Initials': 'AA', 'LastName': 'Kudubes', 'Affiliation': 'Department of Pediatric Nursing, Dokuz Eylul University Faculty of Nursing, Inciralti, 35340, Izmir, Turkey. asliakdeniz@hotmail.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bektas', 'Affiliation': 'Department of Pediatric Nursing, Dokuz Eylul University Faculty of Nursing, Inciralti, 35340, Izmir, Turkey.'}, {'ForeName': 'Kamer', 'Initials': 'K', 'LastName': 'Mutafoğlu', 'Affiliation': 'Department of Pediatrics, Izmir University of Economics Faculty of Medicine, Izmir, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1419-4']
995,30244403,Effect of Educational Intervention Based on the Health Belief Model and Self-Efficacy in Promoting Preventive Behaviors in a Cholangiocarcinoma Screening Group.,"Cholangiocarcinoma (CCA) is a neoplasm known as one of the most common causes of cancer-related deaths in Southeast Asia, particularly in Thailand, Laos, and Cambodia. Prevention and health education are required. Therefore, this study aimed to determine the effectiveness of an educational intervention to prevent CCA among a rural population in Thailand based on the health belief model (HBM) and self-efficacy frameworks. In this quasi-experimental study, 60 participants (30 participants in the experimental group and 30 participants in the control group) were selected in 2017. The educational intervention for the experimental group consisted of seven training sessions (introduction to CCA, risk factors, complications, benefits and barriers to proper consumption of cooked fish, carcinogenic agents, behavioral protection, and self-efficacy in applying preventive behaviors). A questionnaire that consisted of demographic information, knowledge, and HBM constructs (perceived susceptibility, severity, benefits, barriers, cues to action, and self-efficacy) was used to measure CCA preventive behaviors before and 3 months after the intervention. Data were analyzed using SPSS-22 via chi-squared, paired t-tests, and independent samples t tests at a significance level of 0.5. Three months after the intervention, the experimental group showed a significant increase in the knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy, and CCA preventive behaviors compared to the control group. This study showed the effectiveness of the intervention based on the HBM constructs and self-efficacy in the adoption of CCA preventive behaviors 3 months post intervention in the risk group. Thus, these models may serve as a framework for designing and implementing educational interventions for the prevention of CCA.",2019,"Three months after the intervention, the experimental group showed a significant increase in the knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy, and CCA preventive behaviors compared to the control group.","['rural population in Thailand based on the health belief model (HBM) and self-efficacy frameworks', '60 participants (30 participants in the experimental group and 30 participants in the control group) were selected in 2017']","['Educational Intervention', 'educational intervention', 'Cholangiocarcinoma (CCA']","['knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy, and CCA preventive behaviors', 'CCA preventive behaviors', 'demographic information, knowledge, and HBM constructs (perceived susceptibility, severity, benefits, barriers, cues to action, and self-efficacy']","[{'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",60.0,0.0317671,"Three months after the intervention, the experimental group showed a significant increase in the knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy, and CCA preventive behaviors compared to the control group.","[{'ForeName': 'Wirangrong', 'Initials': 'W', 'LastName': 'Srithongklang', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Benchapan', 'Initials': 'B', 'LastName': 'Panithanang', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Pontip', 'Initials': 'P', 'LastName': 'Kompor', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Prasit', 'Initials': 'P', 'LastName': 'Pengsaa', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Natthawut', 'Initials': 'N', 'LastName': 'Kaewpitoon', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand. natthawut.ka@sut.ac.th.'}, {'ForeName': 'Parichart', 'Initials': 'P', 'LastName': 'Wakkhuwatapong', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Soraya J', 'Initials': 'SJ', 'LastName': 'Kaewpitoon', 'Affiliation': 'Parasitic Disease Research Center, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima, Thailand.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1424-7']
996,30116989,The Effects of the Training Program and Counseling Program Given to Women Who Underwent a Mastectomy and Spouses.,"Following breast cancer treatment, many families are negatively affected following the treatment for breast cancer of their women members. This study focused on assessing the effects of the training program and counseling program given to women who underwent a mastectomy and their spouses. Sixty women and 60 spouses were recruited for this study. The women in the experimental group and their spouses were provided with a four-session training program, once a week. Following this training, a 3-month follow-up and counseling were given and an assessment made. There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD). Noting that women in the experimental and control groups demonstrated significant differences among average post-test scores in terms of role emotional (p = .045) and mental health (p = .017) dimensions of Quality of Life Scale (SF-36), a significant difference existed among average post-test scores of spouses in the experimental and control groups in terms of general health (p = .017), role physical (p = .011), role emotional (p = .003), and mental health (p = .005) dimensions of Quality of Life Scale. These results indicated that training and counseling program provided to this population produced positive effects upon family functioning and quality of life.",2019,"There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD).","['Sixty women and 60 spouses', 'women who underwent a mastectomy and their spouses']","['training program and counseling program', 'Training Program and Counseling Program Given to Women']","['mental health', 'family functioning and quality of life', 'role physical', 'general health', 'Quality of Life Scale', 'Quality of Life Scale (SF-36', 'role emotional']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",60.0,0.0206622,"There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD).","[{'ForeName': 'Bahar Kefeli', 'Initials': 'BK', 'LastName': 'Çol', 'Affiliation': 'Recep Tayyip Erdogan University Guneysu Vocational School of Physical Theraphy and Rehabilitation, Rize, Turkey. bahar_kefeli@hotmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Kılıç', 'Affiliation': 'Nursing Faculty, Public Health Nursing Department, Atatürk University, Erzurum, Turkey. dilekk@atauni.edu.tr.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1410-0']
997,31603268,The effect of dopamine on pulmonary diffusing capacity and capillary blood volume responses to exercise in young healthy humans.,"NEW FINDINGS


What is the Central question? Does dopamine, a pulmonary vascular vasodilator, contribute to the regulation of pulmonary diffusing capacity and capillary blood volume responses to exercise and exercise tolerance? What are the main findings and their importance? Dopamine appears not to be important for regulating pulmonary diffusing capacity or pulmonary capillary blood volume during exercise in healthy participants. Dopamine blockade trials demonstrated that endogenous dopamine is important for maintaining exercise tolerance; however, exogenous dopamine does not improve exercise tolerance.
ABSTRACT


Pulmonary capillary blood volume (V c  ) and diffusing membrane capacity (D m  ) expansion are important contributors to the increased pulmonary diffusing capacity (DL CO  ) observed during upright exercise. Dopamine is a pulmonary vascular vasodilator, and recent studies suggest that it may play a role in V c  regulation through changes in pulmonary vascular tone. The purpose of this study was to examine the effect of exogenous dopamine and dopamine receptor-2 (D 2  -receptor) blockade on DL CO  , V c  and D m  at baseline and during cycle exercise, as well as time-to-exhaustion at 85% of    V   ̇   O   2   peak        . We hypothesized that dopamine would increase DL CO  , V c  , D m  and time-to-exhaustion, while D 2  -receptor blockade would have the opposite effect. We recruited 14 young, healthy, recreationally active subjects (    V   ̇   O   2   peak        45.8 ± 6.6 ml kg -1   min -1  ). DL CO  , V c  and D m  were determined at baseline and during exercise at 60% and 85% of    V   ̇   O   2   peak        under the following randomly assigned and double blinded conditions: (1) intravenous saline and placebo pill, (2) intravenous dopamine (2 µg kg -1   min -1  ) and placebo pill, and (3) intravenous saline and D 2  -receptor antagonist (20 mg oral metoclopramide). Exogenous dopamine and dopamine blockade had no effect on DL CO  , V c  and D m  responses at baseline or during exercise. Dopamine blockade reduced time-to-exhaustion by 47% (P = 0.04), but intravenous dopamine did not improve time-to-exhaustion. While dopamine modulation did not affect DL CO  , V c  or D m  , the reduction in time-to-exhaustion with D 2  -receptor blockade suggests that endogenous dopamine is important for exercise tolerance.",2019,"Dopamine blockade reduced time-to-exhaustion by 47% (P = 0.04), but intravenous dopamine did not improve time-to-exhaustion.
CONCLUSION


","['young healthy humans', 'healthy participants', '14 young, healthy, recreationally active subjects (VO 2peak  45.8\xa0±\xa06.6\xa0mL∙kg -1  ∙min -1  ']","['exogenous dopamine and dopamine receptor-2 (D 2  -receptor', 'intravenous saline and placebo pill, 2) intravenous dopamine', 'Dopamine blockade', 'Dopamine', 'placebo pill, 3) intravenous saline and D 2  -receptor antagonist (20\xa0mg oral metoclopramide', 'dopamine']","['DL CO  , Vc, and Dm responses', 'DL CO  , Vc, or Dm', 'time-to-exhaustion', 'DL CO  , Vc, and Dm', 'DL CO  , Vc, Dm, and time-to-exhaustion', 'DL CO  , Vc, and Dm at baseline and during cycle exercise, as well as time-to-exhaustion', 'exercise tolerance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034798', 'cui_str': 'Dopamine Receptor'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",14.0,0.115439,"Dopamine blockade reduced time-to-exhaustion by 47% (P = 0.04), but intravenous dopamine did not improve time-to-exhaustion.
CONCLUSION


","[{'ForeName': 'Wade W', 'Initials': 'WW', 'LastName': 'Michaelchuk', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Tedjasaputra', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Bryan', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Department of Critical Care and Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}]",Experimental physiology,['10.1113/EP088056']
998,31205211,Implementation of a prehospital air medical thawed plasma program: Is it even feasible?,"BACKGROUND


The Prehospital Air Medical Plasma (PAMPer) trial demonstrated a 30-day survival benefit among hypotensive trauma patients treated with prehospital plasma during air medical transport. We characterized resources, costs and feasibility of air medical prehospital plasma program implementation.
METHODS


We performed a secondary analysis using data derived from the recent PAMPer trial. Intervention patients received thawed plasma (5-day shelf life). Unused plasma units were recycled back to blood bank affiliates, when possible. Distribution method and capability of recycling varied across sites. We determined the status of plasma units deployed, utilized, wasted, and returned. We inventoried thawed plasma use and annualized costs for distribution and recovery.
RESULTS


The PAMPer trial screened 7,275 patients and 5,103 plasma units were deployed across 22 air medical bases during a 42-month period. Only 368 (7.2%) units of this total thawed plasma pool were provided to plasma randomized PAMPer patients. Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis. The estimated average annual cost of implementation of a thawed plasma program per air medical base at an average courier distance would be between US $24,343 and US $30,077, depending on the ability to recycle plasma and distance of courier delivery required.
CONCLUSION


A prehospital plasma program utilizing thawed plasma is resource intensive. Plasma waste can be minimized depending on trauma center and blood bank specific logistics. Implementation of a thawed plasma program can occur with financial cost. Products with a longer shelf life, such as liquid plasma or freeze-dried plasma, may provide a more cost-effective prehospital product relative to thawed plasma.
LEVEL OF EVIDENCE


Therapeutic, level III.",2019,"Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis.","['hypotensive trauma patients treated with prehospital plasma during air medical transport', '7,275 patients and 5,103 plasma units were deployed across 22 air medical bases over a 42-month time period']",[],['30-day survival benefit'],"[{'cui': 'C0857353', 'cui_str': 'Hypotensive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",7275.0,0.0353111,"Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis.","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Adams', 'Affiliation': 'From the Division of Trauma and General Surgery, Department of Surgery (P.W.A., K.A.W., J.B.B., A.T.P., B.S.Z., M.D.N., J.L.S.), and Department of Emergency Medicine (F.X.G.), University of Pittsburgh Medical Center; Vitalant, and Department of Pathology (M.H.Y.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (B.J.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.S.M.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (B.G.H.), University of Louisville, Louisville, Kentucky; MetroHealth Medical Center (J.A.C.), Case Western Reserve University, Cleveland, Ohio; Department of Surgery (H.A.P.), University of Texas Southwestern, Parkland Hospital, Dallas; and Health Harris Methodist Hospital (W.R.W.), Fort Worth, Texas.'}, {'ForeName': 'Kayla A', 'Initials': 'KA', 'LastName': 'Warren', 'Affiliation': ''}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daily', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brain G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Witham', 'Affiliation': ''}, {'ForeName': 'A Tyler', 'Initials': 'AT', 'LastName': 'Putnam', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002406']
999,31203776,"Children's Pain, Fear, and Anxiety During Invasive Procedures.","This study was conducted to find out the effects of different means of games used during pediatric blood draw on the levels of procedure-induced fear and anxiety. Patient descriptive information form and selected scales were completed for both the experimental and control group before the blood drawing procedure. During the blood draw procedure, the children in the experimental group listened to music and watched video games. Following the blood draw procedure, the children were given the Fear of Medical Procedure Scale and State Anxiety Inventory for a second time. The results of the study showed that differences between pre- and postprocedure average total scores of Fear of Medical Procedure Scale were statistically significant for all groups ( p  < .05). As a conclusion, it was found that making children listen to music or watch a video during blood draw was effective in decreasing their medical procedure fear levels and state anxiety.",2019,The results of the study showed that differences between pre- and postprocedure average total scores of Fear of Medical Procedure Scale were statistically significant for all groups ( p  < .05).,[],[],"['pre- and postprocedure average total scores of Fear of Medical Procedure Scale', 'Fear of Medical Procedure Scale and State Anxiety Inventory', ""Children's Pain, Fear, and Anxiety"", 'levels of procedure-induced fear and anxiety']",[],[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0199171', 'cui_str': 'Medical procedure'}, {'cui': 'C0222045'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.0170964,The results of the study showed that differences between pre- and postprocedure average total scores of Fear of Medical Procedure Scale were statistically significant for all groups ( p  < .05).,"[{'ForeName': 'Şenay', 'Initials': 'Ş', 'LastName': 'Çelikol', 'Affiliation': '1 Clinical Nursing, Ondokuz Mayis University Hospital, Samsun, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Tural Büyük', 'Affiliation': '2 Assistant Professor, Samsun Health School, Ondokuz Mayıs University Kurupelit Campus, Samsun, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Yıldızlar', 'Affiliation': '3 Assistant Professor, Avrasya University Health Sciences İnstitute, Trabzon, Turkey.'}]",Nursing science quarterly,['10.1177/0894318419845391']
1000,30737891,Weight loss in patients with type 2 diabetes receiving once-weekly dulaglutide plus insulin lispro or insulin glargine plus insulin lispro: A post-hoc analysis of the AWARD-4 study across baseline body mass index subgroups.,"AIMS


Insulin-treated patients with type 2 diabetes (T2D) and obesity are challenged in achieving body weight stability or reduction, in addition to glycaemic control. Post-hoc analyses of body weight and insulin dose data from the AWARD-4 trial involved comparison of treatment with once-weekly dulaglutide 1.5 mg (N = 295) or 0.75 mg (N = 293) and treatment with daily insulin glargine (N = 296), each with prandial insulin lispro (± metformin).
MATERIALS AND METHODS


Changes in weight and in the proportion of patients without weight gain or with weight loss of at least 3%, 5% or 10% or composites of HbA1c less than 7% without weight gain and weight loss of at least 3% after 52 weeks were compared between the dulaglutide (either dose) groups and the insulin glargine group, overall and by baseline BMI (<30, 30-<35, ≥35 kg/m 2  ), using analysis of covariance and logistic regression, including interaction terms.
RESULTS


The following parameters were statistically significant (P < 0.01) in favour of the dulaglutide-treated groups, at lower mean total daily insulin doses, vs the insulin glargine group. The achieved targets were more pronounced with dulaglutide 1.5 mg than with insulin glargine: LSM weight change difference, -3.23 kg; proportion of patients without weight gain, 49.0% vs 19.0%; proportion of patients with weight loss ≥3%, 21.7% vs 5.7% or with weight loss ≥5%, 10.5% vs 2.4%; proportion of patients with HbA1c <7% without weight gain, 26.2% vs 7.9%; proportion of patients with HbA1c <7% and weight loss ≥3%, 11.9% vs 1.4%, respectively. Treatment effect for these parameters was not significantly different across BMI categories.
CONCLUSIONS


Larger proportions of patients in late-stage T2D needing treatment intensification achieved glycemic control without weight gain or with weight loss at lower insulin doses with once-weekly dulaglutide plus daily prandial insulin than with a basal-bolus insulin regimen, overall and across all three BMI subgroups.",2019,"The following parameters were statistically significant (P < 0.01) in favour of the dulaglutide-treated groups, at lower mean total daily insulin doses, vs the insulin glargine group.","['treated patients with type 2 diabetes (T2D) and obesity', 'Changes in weight and in the proportion of patients without weight gain or with weight loss of at least 3%, 5% or 10% or composites of HbA1c less than 7% without weight gain and weight loss of at least 3% after 52\u2009weeks', 'patients with type 2 diabetes receiving once-weekly']","['Insulin', 'prandial insulin lispro (± metformin', 'insulin glargine: LSM', 'dulaglutide plus insulin lispro or insulin glargine plus insulin lispro', 'daily insulin glargine', 'insulin glargine']","['Weight loss', 'glycemic control without weight gain or with weight loss']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0532132,"The following parameters were statistically significant (P < 0.01) in favour of the dulaglutide-treated groups, at lower mean total daily insulin doses, vs the insulin glargine group.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fuechtenbusch', 'Affiliation': 'Diabeteszentrum am Marienplatz, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aberle', 'Affiliation': 'Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Heitmann', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nicolay', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13658']
1001,31205105,Trimetazidine in angina and poor muscle function: protocol for a randomized controlled study.,"BACKGROUND


Low handgrip strength (HS) and declining gait speed (GS) are increasingly obvious with aging, requiring effective, and safe medication for treatment. Trimetazidine (TMZ) modified release tablets, a common anti-angina drug, has potential benefits for alleviating the condition, but this has not yet been fully studied and therefore is the aim of this study.
METHODS


This is a prospective randomized controlled study. Fifty-eight eligible patients will be randomly assigned to one of two study groups: TMZ group or control group. For the TMZ group, a dose of 35 mg of oral TMZ will be administered with a meal twice a day for 3 months, in addition to any conventional treatments for angina. Only conventional treatments for angina will be administrated in the control group. The primary outcome will be the 6-min walking distance and the secondary outcomes will be: muscle strength (HS and pinch strength), GS, muscle endurance (five times sit-to-stand test), balance maintenance (tandem standing test), and the frequency of angina per week. Additionally, body mass index, circumferences (biceps, waist, hip, and calf), albumin levels, and the score on a five-question scale for sarcopenia will be obtained during the study.
DISCUSSION


This study aims to evaluate the usefulness of TMZ in a population with poor muscle function. The results may provide an effective and safe medical treatment to people with low muscle strength or physical performance.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800015000; www.chictr.org.cn/showproj.aspx?proj=25445.",2019,"Additionally, body mass index, circumferences (biceps, waist, hip, and calf), albumin levels, and the score on a five-question scale for sarcopenia will be obtained during the study.
","['population with poor muscle function', 'Fifty-eight eligible patients']","['Trimetazidine', 'oral TMZ', 'TMZ', 'Trimetazidine (TMZ', 'Low handgrip strength (HS) and declining gait speed (GS', 'TMZ group or control group']","['6-min walking distance and the secondary outcomes will be: muscle strength (HS and pinch strength), GS, muscle endurance (five times sit-to-stand test), balance maintenance (tandem standing test), and the frequency of angina per week', 'body mass index, circumferences (biceps, waist, hip, and calf), albumin levels, and the score on a five-question scale for sarcopenia']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}]",58.0,0.0997254,"Additionally, body mass index, circumferences (biceps, waist, hip, and calf), albumin levels, and the score on a five-question scale for sarcopenia will be obtained during the study.
","[{'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Geriatric Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Jing-Xin', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Zhengzhou Central Hospital, Zhengzhou University, Zhengzhou, Henan 450007, China.'}, {'ForeName': 'Shi-Hui', 'Initials': 'SH', 'LastName': 'Fu', 'Affiliation': ""Department of Geriatric Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': ""Department of Geriatric Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}]",Chinese medical journal,['10.1097/CM9.0000000000000267']
1002,31764271,Implementation Science Using Proctor's Framework and an Adaptation of the Multiphase Optimization Strategy: Optimizing a Financial Incentive Intervention for HIV Treatment Adherence in Tanzania.,"BACKGROUND


Ambitious targets have been set to end the HIV epidemic by 2030. Such targets assume that tools to end HIV exist and are successfully being deployed across populations, albeit unequally. Implementation science approaches are needed to understand the drivers of disparities and how to bring effective interventions to those most in need. We describe a hybrid implementation science approach, adapting a strategy to facilitate retention and viral suppression (VS) among people living with HIV/AIDS in Tanzania.
METHODS/DESIGN


We used Proctor framework and the multiphase optimization strategy to optimize a cash transfer to improve antiretroviral therapy adherence and VS among people living with HIV/AIDS in Tanzania. This involved 3 trials. The first trial tested the efficacy of cash and food assistance compared with the standard of care in improving antiretroviral therapy adherence among treatment initiators. Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food. The second trial is dose-finding: identifying the optimal amount of cash for a 20% improvement in VS at 6 months. Before this, components were simplified to maximize reach, align with local policies, and reduce staff time. We assessed implementation science constructs to understand barriers to uptake and sustainability. Trial 3 is a cluster randomized controlled trial, testing the effectiveness of the optimized intervention in multiple settings.
DISCUSSION/IMPLICATIONS


Our process illustrates the utility of applying multiple implementation science frameworks to arrive at an optimal implementation strategy to bridge the know-do gap with data to show efficacy and maximum potential for scalability and sustainability.",2019,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","['people living with HIV/AIDS in Tanzania', 'HIV Treatment Adherence in Tanzania']","['Financial Incentive Intervention', 'cash and food assistance']",[],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3494395', 'cui_str': 'Food Assistance'}]",[],,0.109746,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Packel', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fahey', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Prosper', 'Initials': 'P', 'LastName': 'Njau', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002196']
1003,31200891,Exercise intervention in the management of urinary incontinence in older women in villages in Bangladesh: a cluster randomised trial.,"BACKGROUND


Group exercise-based programmes for urinary incontinence appear to be promising low-cost interventions for women in developing countries, but no evidence exists to support whether they could be implemented or effective in such populations. We aimed to evaluate whether a group intervention that comprised pelvic floor muscle training, mobility exercises, and bladder education would be more effective than education alone, and report changes between villages (ie, clusters) rather than between individual participants.
METHODS


In this cluster randomised trial, we recruited women from 16 pairs of villages in Bangladesh, with each pair comprising similar villages from the same sub-district. Women aged 60-75 years were interviewed to establish eligibility. Women were eligible if they had current urinary incontinence, and were excluded if they had a third degree or higher uterine prolapse, if they were unable to walk or stand without help, or if they had insufficient intellectual capacity to understand questions and follow instructions. The villages were randomly assigned within each pair to either exercise plus education or education-only intervention by use of a random number generator from a fixed seed. Women were excluded after consenting if they lived too far from the centre of the village. The exercise intervention was a physiotherapist-led group exercise class that was held twice weekly for 12 weeks, with home exercises between classes and to 24 weeks. Both groups received bladder-health education. Participants were followed up for 24 weeks. A 3-day continence record was collected at recruitment and every 4 weeks up until 24 weeks. This record involved the participant tying a knot in ribbons worn under the clothing each time they had an episode of urinary leakage. The primary outcome was change in number of knots (recorded leakage episodes) from recruitment to 24 weeks. Safety was assessed in all participants in the exercise intervention group. The trial is registered at ClinicalTrials.gov, number NCT02453100.
FINDINGS


Between Aug 22, 2015, and July 2, 2018, of 3577 women aged 60-75 years identified, 1003 were eligible, of whom 625 consented to participate (n=335 exercise plus education villages, and n=290 in education-only villages). Of these consenting women, 46 were excluded (n=37 exercise plus education, n=9 education only) because they lived too far from the centre of the village. At week 24, 283 (95%) of 298 in the exercise plus education group and 274 (98%) of 281 in the education-only group completed a 3-day continence record. The estimate of change in number of leakage episodes between baseline and 24 weeks was -7·7 (95% CI -10·6 to -4·8) at the village level in an unadjusted model, and -6·64 (-7·95 to -5·33) in a random-effects model accounting for cluster randomisation. No adverse events were reported.
INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
FUNDING


Canadian Institutes for Health Research.",2019,"INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
","['Between Aug 22, 2015, and July 2, 2018, of 3577 women aged 60-75 years identified, 1003 were eligible, of whom 625 consented to participate (n=335 exercise plus education villages, and n=290 in education-only villages', 'Women aged 60-75 years', 'older women in villages in Bangladesh', 'consenting women, 46 were excluded (n=37 exercise plus education, n=9 education only) because they lived too far from the centre of the village', 'older women in communities largely outside the reach of pharmaceutical or surgical interventions', 'recruited women from 16 pairs of villages in Bangladesh, with each pair comprising similar villages from the same sub-district', 'Women were excluded after consenting if they lived too far from the centre of the village', 'Women were eligible if they had current urinary incontinence, and were excluded if they had a third degree or higher uterine prolapse, if they were unable to walk or stand without help, or if they had insufficient intellectual capacity to understand questions and follow instructions']","['exercise intervention', 'pelvic floor muscle training, mobility exercises, and bladder education', 'Exercise intervention', 'exercise plus education or education-only intervention by use of a random number generator from a fixed seed']","['adverse events', 'urinary incontinence', 'number of leakage episodes', 'change in number of knots (recorded leakage episodes', 'Safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0067954', 'cui_str': 'TOOS'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0443323', 'cui_str': 'Third degree (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042140', 'cui_str': 'Uterine Prolapse'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk (finding)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3577.0,0.27217,"INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Zafrullah', 'Initials': 'Z', 'LastName': 'Chowdhury', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Galarneau', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rezaul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh; Department of Social Medicine, Gono Bishwabidyalay University, Savar, Bangladesh.'}, {'ForeName': 'Fardous', 'Initials': 'F', 'LastName': 'Kabir', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'MacDonald', 'Affiliation': 'Lois Hole Hospital for Women, Edmonton, AB, Canada.'}, {'ForeName': 'Kamrun', 'Initials': 'K', 'LastName': 'Naher', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh; Department of Physiotherapy, Gono Bishwabidyalay University, Savar, Bangladesh.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cherry', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada. Electronic address: nicola.cherry@ualberta.ca.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30205-0']
1004,31772100,Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care.,"INTRODUCTION


Although a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients' perception of symptom relief and their ability to return to normal daily activities and work.
METHODS AND ANALYSIS


This is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.
ETHICS AND DISSEMINATION


The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03979443.",2019,"We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%.","['Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov', 'patients with cervical radiculopathy syndrome', 'inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8\u2009hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure']","['traditional hospital surveillance', 'Anterior Cervical Decompression and Fusion (FACADE']","['Neck Disability Index (NDI', ""arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications"", 'duration of sick leave']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0222045'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}]",104.0,0.1606,"We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%.","[{'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Lönnrot', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland kimmo.lonnrot@hus.fi.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Koski-Palken', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Frantzen', 'Affiliation': 'Division of Clinical neurosciences, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Leinonen', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kys, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Silvasti-Lundell', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Förster', 'Affiliation': 'Department of Anaesthesia, Orthopaedic Hospital Orton, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Jarvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032575']
1005,31772102,Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial.,"INTRODUCTION


An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.
METHODS AND ANALYSIS


This will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.
ETHICS AND DISSEMINATION


This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Register (ChiCTR1900024131).",2019,An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery.,"['2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB', 'Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College ', 'paediatric cardiac surgery', 'paediatric patients undergoing cardiac surgery']","['tranexamic acid', 'tranexamic acid (TXA', 'TXA', 'TXA or placebo']","['efficacy and safety', 'Safety and efficacy', 'postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB', 'postoperative allogeneic transfusion', 'incidence of seizures']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2090.0,0.613172,An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Paediatric Intensive Care Unit, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Cardiopulmonary Bypass, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ran', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongdong', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shoujun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shengshou', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yanfuxiafw@sina.com wangyfuwai@sohu.com.'}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yanfuxiafw@sina.com wangyfuwai@sohu.com.'}]",BMJ open,['10.1136/bmjopen-2019-032642']
1006,31784442,Intradermal thumbtack needle buried Neiguan (P6) point for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative nausea and vomiting (PONV) is among the most common adverse reactions following anaesthesia and surgery. Recent clinical studies have reported that the average incidence is about 30%, while in patients specifically undergoing neurosurgery, the incidence can be as great as 73%. Studies also suggest that its occurrence increases the risk of intracranial haematoma and haemorrhage. The objective of this study is to evaluate the effectiveness of intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy in the prevention of PONV in patients undergoing craniotomy under general anaesthesia.
METHODS AND ANALYSIS


This is a single-centre, three-arm, randomised controlled trial. 180 participants are randomly assigned to either an acupuncture, intradermal thumbtack needle or control group in a 1:1:1 ratio. The P6 of the acupuncture group is punctured at both sides perpendicularly to a depth of 20 mm. Needles are retained for 30 min and stimulated every 10 min to maintain the de qi. The therapy includes two treatments; the acupuncture is administered immediately after and 24 hours after surgery. For the intradermal thumbtack needle group, the intradermal thumbtack needle is quickly inserted into the skin and embedded at P6 acupoints bilaterally. Patients and their families are asked to press the needlepoint with the onset of nausea, vomiting, bloating, pain and other reported discomforts. The needle is replaced after 24 hours. The therapy is administered immediately after and 24 hours after surgery. For the control group, no intervention is carried out. The incidence of PONV within 48 hours after craniotomy across the three groups is observed. Other observations include: (1) assessment of nausea score (severity of nausea) and pain score (visual analogue scale) 0-2, 2-6, 6-24 and 24-48 hours after craniotomy under general anaesthesia; (2) assessment of total rescue antiemetic dosage 0-48 hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management. We will perform all statistical analysis following the intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Bioethics Subcommittee of the West China Hospital, Sichuan University: the approval number is 2018 (number 231). Results will be expected to be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR1800017173.",2019,The incidence of PONV within 48 hours after craniotomy across the three groups is observed.,"['patients undergoing craniotomy under general anaesthesia', 'patients undergoing craniotomy', '180 participants']","['acupuncture', 'acupuncture, intradermal thumbtack needle or control', 'intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy', 'Intradermal thumbtack needle buried Neiguan (P6']","['risk of intracranial haematoma and haemorrhage', 'incidence of PONV', 'postoperative nausea and vomiting', 'total rescue antiemetic dosage 0-48\u2009hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management', 'nausea score (severity of nausea) and pain score (visual analogue scale', 'nausea, vomiting, bloating, pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031050', 'cui_str': 'Pericardium'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0596793', 'cui_str': 'Intracranial hematoma'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",180.0,0.107992,The incidence of PONV within 48 hours after craniotomy across the three groups is observed.,"[{'ForeName': 'Jian-Qin', 'Initials': 'JQ', 'LastName': 'Lv', 'Affiliation': 'Integrated Traditional and Western Medicine Department, Sichuan University West China Hospital, Chengdu, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Integrated Traditional and Western Medicine Department, Sichuan University West China Hospital, Chengdu, China wangchengwei@wchscu.cn.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tian-Hao', 'Initials': 'TH', 'LastName': 'Xu', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ling-Qi', 'Initials': 'LQ', 'LastName': 'Jian', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}]",BMJ open,['10.1136/bmjopen-2019-032417']
1007,31378647,Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial.,"BACKGROUND


Intake of vegetables in children remains low.
OBJECTIVE


To compare taste exposure (TE), nutrition education (NE) and TE+NE together on intake of an unfamiliar vegetable (mooli/daikon radish) in preschool-aged children.
DESIGN


Children attending 11 preschools in England were randomly assigned by clusters to four intervention conditions using a 2×2 factorial design: TE, NE, TE+NE, and no intervention (control).
PARTICIPANTS


Two hundred nineteen children aged 2 to 5 years participated from September 2016 to June 2017.
INTERVENTION


The intervention period was 10 weeks preceded and followed by measurements of raw mooli intake as a snack. Preschools were randomized to receive weekly TE at snack time (n=62 children); NE (n=68) using the PhunkyFoods program; TE+NE (n=55) received both weekly taste exposures at snack and lessons from the PhunkyFoods program; and the control condition (n=34), received NE after the final follow-up measurement.
MAIN OUTCOME MEASURES


Individual measured intakes of mooli at Week 1 (baseline), Week 12 (postintervention), and Week 24 and Week 36 (follow-ups).
STATISTICAL ANALYSIS


Differences in intakes were analyzed by cluster. Logistic regressions were conducted to examine odds ratios for intake patterns.
RESULTS


Data from 140 children with complete mooli intake assessments were analyzed. TE increased intake from 4.7±1.4 g to 17.0±2.0 g and this was maintained at both follow-ups. Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8). Combining TE and NE produced no additional benefit to intake beyond TE alone.
CONCLUSIONS


Taste exposures encouraged children to eat more of the unfamiliar vegetable, whereas nutrition education encouraged children who were noneaters to try the vegetable. Both approaches were effective and can be used to produce different outcomes.",2019,"Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8).","['preschool-aged children', 'Preschool Children', 'Children attending 11 preschools in England', 'Two hundred nineteen children aged 2 to 5 years participated from September 2016 to June\xa02017', '140 children with complete mooli intake assessments', 'n=62 children); NE (n=68) using the']","['PhunkyFoods program; TE+NE (n=55) received both weekly taste exposures at snack and lessons from the PhunkyFoods program; and the control condition', 'TE at snack time', 'taste exposure (TE), nutrition education (NE) and TE+NE together on intake of an unfamiliar vegetable (mooli/daikon radish', 'TE, NE, TE+NE, and no intervention (control', 'NE']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0585041', 'cui_str': 'Snack time (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0330515', 'cui_str': 'Radish'}]",[],219.0,0.0781016,"Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8).","[{'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'Nekitsing', 'Affiliation': ''}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Blundell-Birtill', 'Affiliation': ''}, {'ForeName': 'Jennie E', 'Initials': 'JE', 'LastName': 'Cockroft', 'Affiliation': ''}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Hetherington', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.012']
1008,29443404,"New, Immunomodulatory, Oral Nutrition Formula for Use Prior to Surgery in Patients With Head and Neck Cancer: An Exploratory Study.","BACKGROUND


The perioperative use of immunomodulatory nutrition formulas in patients with head and neck cancer reduces the number of postoperative infections and the length of hospital stay.
OBJECTIVE


An exploratory, randomized, controlled, blind, clinical trial was designed to examine the effect of the preoperative consumption of a new, immunomodulatory, oral nutrition formula in patients with head and neck cancer.
METHODS


Thirty-eight patients were randomized to receive either 400 mL/d of either the new immunomodulatory formula (IF) or that commonly used in clinical practice (CF) over 10 days prior to surgery. Thirty-three patients completed the study. Compliance, tolerance, the length of hospital stay, the incidence of infections and noninfectious complications before discharge, and the same up to 15 and 30 days after discharge were recorded.
RESULTS


The percentage of patients who developed infections before discharge was significantly lower in the IF than in the CF group (P = .013), as was the number of infections/100 patients/d (P = .035). The length of hospital stay was significantly shorter in the IF group (P = .001). Both formulas were safe and well tolerated. No other differences were detected. These results suggest preoperative consumption of the new formula to be beneficial for patients with neck and head cancer. Further trials are needed to confirm these results and to test the efficacy of the formula in patients with other conditions.
CONCLUSION


The new formula can be safely prescribed as part of the preoperative treatment of patients with head and neck cancer and might reduce the problem of postoperative infection.",2018,The length of hospital stay was significantly shorter in the IF group (P = .001).,"['patients with neck and head cancer', 'Patients With Head and Neck Cancer', 'Thirty-eight patients', 'patients with other conditions', 'Thirty-three patients completed the study', 'patients with head and neck cancer']",['new immunomodulatory formula'],"['infections before discharge', 'Compliance, tolerance, the length of hospital stay, the incidence of infections and noninfectious complications', 'safe and well tolerated', 'length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0751177', 'cui_str': 'Cancer of Head'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",38.0,0.0270454,The length of hospital stay was significantly shorter in the IF group (P = .001).,"[{'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Palma-Milla', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Santamaría', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'de Arriba-Sánchez', 'Affiliation': 'Otolaryngology Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, Madrid, Spain.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1177/0148607116676839']
1009,31209957,Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia during transrectal ultrasound-guided prostate biopsy: A prospective randomized controlled trial.,"OBJECTIVES


To compare the efficacy, safety and cost of combinations of perineal pudendal nerve block + periprostatic nerve block and intrarectal local anesthesia + periprostatic nerve block with the standard technique (periprostatic nerve block).
METHODS


The study was designed as a randomized prospective controlled trial. Patients with elevated serum prostate-specific antigen values (prostate-specific antigen ≥4 ng/mL) and/or abnormal digital rectal examination findings were included in the study. Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study. A total of 148 patients (group 1 [periprostatic nerve block], n = 48; group 2 [intrarectal local anesthesia + periprostatic nerve block], n = 51; group 3 [perineal pudendal nerve block + periprostatic nerve block], n = 49) were included in the final analysis. Pain during insertion and manipulation of the transrectal ultrasound probe was recorded as visual analog scale 1, pain during penetration of the biopsy needle into the prostate and sampling was recorded as visual analog scale 2, and pain during the entire procedure recorded as visual analog scale 3.
RESULTS


The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001). There was no significant difference between the groups in terms of the mean visual analog scale 2 score. The mean visual analog scale 3 score was significantly lower in group 3 when compared with other groups (P < 0.001). The total cost for transrectal ultrasound-guided biopsy in the intrarectal local anesthesia + periprostatic nerve block group was significantly higher than the other two groups.
CONCLUSIONS


The combination of perineal pudendal nerve block and periprostatic nerve block provides more effective pain control than intrarectal local anesthesia plus periprostatic nerve block and periprostatic nerve block alone, with similar complication rates and without increasing cost.",2019,"The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001).","['Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study', '148 patients (group\xa01 [periprostatic nerve block], n = 48; group\xa02 ', 'Patients with elevated serum prostate-specific antigen values (prostate-specific antigen']","['Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia', 'intrarectal local anesthesia\xa0+\xa0periprostatic nerve block], n = 51; group\xa03 [perineal pudendal nerve block\xa0+\xa0periprostatic nerve block', 'perineal pudendal nerve block and periprostatic nerve block', 'perineal pudendal nerve block\xa0+\xa0periprostatic nerve block and intrarectal local anesthesia\xa0+\xa0periprostatic nerve block', 'transrectal ultrasound-guided prostate biopsy']","['mean visual analog scale', 'Pain', 'mean visual analog scale\xa03 score', 'mean visual analog scale\xa01 score', 'total cost for transrectal ultrasound-guided biopsy', 'efficacy, safety and cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687707', 'cui_str': 'Anorectal Disorders'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0228959', 'cui_str': 'Pudendal Nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",148.0,0.10246,"The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001).","[{'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Aslan', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sebahattin', 'Initials': 'S', 'LastName': 'Celik', 'Affiliation': 'Department of General Surgery, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Ucpinar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Taken', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14036']
1010,30761717,"Effect of cilostazol, a phosphodiesterase-3 inhibitor, on coronary artery stenosis and plaque characteristics in patients with type 2 diabetes: ESCAPE study.","AIM


To perform a prospective study to evaluate the effect of cilostazol (CTZ) compared with aspirin (acetylsalicylic acid; ASA) in Korean people with diabetes and subclinical coronary atherosclerosis.
MATERIALS AND METHODS


A total of 100 people with diabetes who had mild to moderate coronary atherosclerosis, assessed by coronary computed tomographic angiography (CCTA), were randomly assigned to either 200 mg/d CTZ or 100 mg/d ASA (n = 50 each group). The primary outcome was change in coronary artery stenosis assessed by CCTA after 12 months of treatment. Secondary outcomes included changes in plaque composition, coronary artery calcium score and cardiac markers.
RESULTS


The mean age, body mass index and glycated haemoglobin concentration were 61.5 years, 25.0 kg/m 2  and 56.8 mmol/mol, respectively, and were well matched between the two groups. Coronary artery stenosis decreased in the CTZ group (from 44.0 ± 2.1% to 40.4 ± 2.5%) but remained unchanged in the ASA group (from 38.9 ± 2.1% to 40.6 ± 2.1%). In the CTZ group, the non-calcified portion of plaques decreased significantly (from 20.6 ± 3.0 to 17.3 ± 3.0 mm 3  ), whereas it did not change significantly in the ASA group (15.2 ± 2.8 vs 16.6 ± 2.9 mm 3  ). Increases in HDL cholesterol, decreases in triglycerides, liver enzyme and high-sensitivity C-reactive protein levels, and reductions in abdominal visceral fat area and insulin resistance were observed only in the CTZ group.
CONCLUSION


CTZ treatment for 12 months decreased coronary artery stenosis and the non-calcified plaque component. These results suggest that CTZ treatment may be an option for preventing the progression of coronary atherosclerosis in people with diabetes.",2019,"Increases in HDL cholesterol, decreases in triglycerides, liver enzyme and high-sensitivity C-reactive protein levels, and reductions in abdominal visceral fat area and insulin resistance were observed only in the CTZ group.
","['100 people with diabetes who had mild to moderate coronary atherosclerosis, assessed by coronary computed tomographic angiography (CCTA', 'Korean people with diabetes and subclinical coronary atherosclerosis', 'patients with type 2 diabetes', 'people with diabetes']","['200\u2009mg/d CTZ or 100\u2009mg/d ASA', 'aspirin (acetylsalicylic acid; ASA', 'cilostazol (CTZ', 'CTZ', 'cilostazol, a phosphodiesterase-3 inhibitor']","['HDL cholesterol', 'coronary artery stenosis and plaque characteristics', 'changes in plaque composition, coronary artery calcium score and cardiac markers', 'abdominal visceral fat area and insulin resistance', 'non-calcified portion of plaques', 'coronary artery stenosis', 'change in coronary artery stenosis assessed by CCTA', 'coronary atherosclerosis', 'triglycerides, liver enzyme and high-sensitivity C-reactive protein levels', 'mean age, body mass index and glycated haemoglobin concentration', 'Coronary artery stenosis']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C2267032', 'cui_str': 'PDE3 Inhibitors'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",100.0,0.0728346,"Increases in HDL cholesterol, decreases in triglycerides, liver enzyme and high-sensitivity C-reactive protein levels, and reductions in abdominal visceral fat area and insulin resistance were observed only in the CTZ group.
","[{'ForeName': 'Dong-Hwa', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Chun', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Tae Jung', 'Initials': 'TJ', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Kyoung Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Kyong Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hak Chul', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13667']
1011,31778115,Using Cluster Analysis to Explore Engagement and e-Attainment as Emergent Behavior in Electronic Mental Health.,"BACKGROUND


In most e-mental health (eMH) research to date, adherence is defined according to a trial protocol. However, adherence to a study protocol may not completely capture a key aspect of why participants engage with eMH tools, namely, to achieve personal mental health goals. As a consequence, trial attrition reported as non-adherence or dropout may reflect e-attainment, the discontinuation of eMH engagement after personal goals have been met. Clarifying engagement patterns, such as e-attainment, and how these align with mental health trajectories, may help optimize eMH design and implementation science.
OBJECTIVE


This study aimed to use clustering techniques to identify real-world engagement profiles in a community of eMH users and examine if such engagement profiles are associated with different mental health outcomes. The novelty of this approach was our attempt to identify actual user engagement behaviors, as opposed to employing engagement benchmarks derived from a trial protocol. The potential of this approach is to link naturalistic behaviors to beneficial mental health outcomes, which would be especially informative when designing eMH programs for the general public.
METHODS


Between May 2013 and June 2018, Australian adults (N=43,631) signed up to myCompass, a self-guided eMH program designed to help alleviate mild to moderate symptoms of depression, anxiety, and stress. Recorded usage data included number of logins, frequency of mood tracking, number of started and completed learning activities, and number of tracking reminders set. A subset of users (n=168) completed optional self-assessment mental health questionnaires (Patient Health Questionnaire-9 item, PHQ-9; Generalized Anxiety Disorder Questionnaire-7 item, GAD-7) at registration and at 28 and 56 days after sign-up. Another subset of users (n=861) completed the PHQ-9 and GAD-7 at registration and at 28 days.
RESULTS


Two-step cluster analyses revealed 3 distinct usage patterns across both subsamples: moderates, trackers, and super users, signifying differences both in the frequency of use as well as differences in preferences for program functionalities. For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores. Time-by-cluster interactions, however, did not yield statistical significance in both subsamples, indicating that clusters did not predict symptom reduction over time. Interestingly, users who completed the self-assessment questionnaires twice had slightly but significantly lower depression and anxiety levels at sign-up compared with users who completed the questionnaires a third time at 56 days.
CONCLUSIONS


Findings suggested that although users engaged with myCompass in different but measurable ways, those different usage patterns evoked equivalent mental health benefits. Furthermore, the randomized controlled trial paradigm may unintentionally limit the scope of eMH engagement research by mislabeling early mental health goal achievers as dropouts. More detailed and naturalistic approaches to study engagement with eMH technologies may improve program design and, ultimately, program effectiveness.",2019,"For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores.","['Between May 2013 and June 2018, Australian adults (N=43,631) signed up to myCompass, a self-guided eMH program designed to help alleviate mild to moderate symptoms of depression, anxiety, and stress']",[],"['time in PHQ-9 and GAD-7 scores', 'depression and anxiety levels', 'optional self-assessment mental health questionnaires (Patient Health Questionnaire-9 item, PHQ-9; Generalized Anxiety Disorder Questionnaire-7 item, GAD-7', 'number of logins, frequency of mood tracking, number of started and completed learning activities, and number of tracking reminders set']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",,0.107925,"For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores.","[{'ForeName': 'Samineh', 'Initials': 'S', 'LastName': 'Sanatkar', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Peter Andrew', 'Initials': 'PA', 'LastName': 'Baldwin', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Huckvale', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, Sydney, Australia.'}]",Journal of medical Internet research,['10.2196/14728']
1012,31774402,User Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


The success of a mobile phone app in changing health behavior is thought to be contingent on engagement, commonly operationalized as frequency of use.
OBJECTIVE


This subgroup analysis of the 2 intervention arms from a 3-group randomized controlled trial aimed to examine user engagement with a 100-day physical activity intervention delivered via an app. Rates of engagement, associations between user characteristics and engagement, and whether engagement was related to intervention efficacy were examined.
METHODS


Engagement was captured in a real-time log of interactions by users randomized to either a gamified (n=141) or nongamified version of the same app (n=160). Physical activity was assessed via accelerometry and self-report at baseline and 3-month follow-up. Survival analysis was used to assess time to nonuse attrition. Mixed models examined associations between user characteristics and engagement (total app use). Characteristics of super users (top quartile of users) and regular users (lowest 3 quartiles) were compared using t tests and a chi-square analysis. Linear mixed models were used to assess whether being a super user was related to change in physical activity over time.
RESULTS


Engagement was high. Attrition (30 days of nonuse) occurred in 32% and 39% of the gamified and basic groups, respectively, with no significant between-group differences in time to attrition (P=.17). Users with a body mass index (BMI) in the healthy range had higher total app use (mean 230.5, 95% CI 190.6-270.5; F 2 =8.67; P<.001), compared with users whose BMI was overweight or obese (mean 170.6, 95% CI 139.5-201.6; mean 132.9, 95% CI 104.8-161.0). Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6). Super users were 4.6 years older (t 297 =3.6; P<.001) and less likely to have a BMI in the obese range (χ 2 2 =15.1; P<.001). At the 3-month follow-up, super users were completing 28.2 (95% CI 9.4-46.9) more minutes of objectively measured physical activity than regular users (F 1,272 =4.76; P=.03).
CONCLUSIONS


Total app use was high across the 100-day intervention period, and the inclusion of gamified features enhanced engagement. Participants who engaged the most saw significantly greater increases to their objectively measured physical activity over time, supporting the theory that intervention exposure is linked to efficacy. Further research is needed to determine whether these findings are replicated in other app-based interventions, including those experimentally evaluating engagement and those conducted in real-world settings.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000113358; https://www.anzctr.org.au/ACTRN12617000113358.aspx.",2019,"Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6).",[],['100-day physical activity intervention delivered via an app'],"['Physical activity', 'Attrition', 'time to attrition', 'physical activity']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.325785,"Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Edney', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Ryan', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Adelaide, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Olds', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Monroe', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Fraysse', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, School of Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Curtis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}]",Journal of medical Internet research,['10.2196/14645']
1013,31773199,Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function.
METHODS


In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test.
RESULTS


Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as ""more difficult than average"" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation.
CONCLUSIONS


Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.",2019,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","['105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation', 'women undergoing MIS']","['minimally invasive sacrocolpopexy (MIS', 'Bowel preparation prior to minimally invasive sacrocolpopexy', 'pre-operative bowel preparation or no bowel preparation']","['report strain', ""surgeon's perception of case difficulty"", 'Baseline characteristics and rates of complications', 'ITT', 'post-operative abdominal PAC-SYM subscale', 'Constipation Symptoms (PAC-SYM', 'post-operative constipation']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",105.0,0.298916,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA. sassanijc@upmc.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'Banner University Medical Center, University of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04120-7']
1014,31378648,Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial.,"BACKGROUND


Most children eat fewer vegetables than recommended. Storybooks and sensory play may increase vegetable intake.
OBJECTIVE


This study tested the effects on intake of learning about an unfamiliar vegetable (celeriac) through storybooks and sensory play. It was predicted that an illustrated, congruent storybook would increase intake of celeriac compared to an incongruent storybook (carrot); and that adding congruent sensory play with celeriac to the storybook would produce a synergistic effect on intake of celeriac.
DESIGN


Children from 12 UK preschools were randomly assigned by clusters to four intervention conditions using a 2×2 factorial design. The factors were vegetable congruency (sensory play and/or storybook were congruent, or incongruent [carrot] with celeriac) and intervention type (storybook only or storybook combined with sensory play).
PARTICIPANTS/SETTING


Three hundred and thirty-seven children aged 2 to 5 years were recruited to take part in November 2017.
INTERVENTION


Over a 2-week period, children in all four conditions were read a vegetable storybook featuring celeriac or carrot. In addition, two conditions received sensory play with either carrot or celeriac added to the storybook method.
MAIN OUTCOME MEASURES


Intake of the unfamiliar vegetable (celeriac) was measured at baseline and after the 2-week intervention.
STATISTICAL ANALYSIS PERFORMED


Complex samples logistic regression and general linear modeling were performed to examine group differences at post-intervention.
RESULTS


Children receiving the congruent (celeriac) storybook had higher odds of eating celeriac compared to children who received the incongruent (carrot) storybook. Receiving congruent sensory play increased the odds of eating celeriac, whereas receiving incongruent sensory play did not. From the 267 children who completed both baseline and post-intervention assessments, 85 ate no celeriac at baseline and were classed as non-eaters. Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions.
CONCLUSIONS


Congruency between storybook and vegetable increased intake; sensory play with celeriac increased the likelihood of eating celeriac. Storybooks and sensory play are simple interventions to increase willingness to try an unfamiliar vegetable.",2019,"Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions.
","['Children from 12 UK preschools', '267 children who completed both baseline and post-intervention assessments, 85 ate no celeriac at baseline and were classed as non-eaters', 'Three hundred and thirty-seven children aged 2 to 5 years were recruited to take part in November\xa02017', 'Preschool Children Through Learning']","['sensory play with either carrot or celeriac added to the storybook method', 'vegetable congruency (sensory play and/or storybook were congruent, or incongruent [carrot] with celeriac) and intervention type (storybook only or storybook combined with sensory play', 'learning about an unfamiliar vegetable (celeriac) through storybooks and sensory play']","['odds of eating celeriac', 'Intake of the unfamiliar vegetable (celeriac', 'likelihood of eating celeriac', 'eating celeriac']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1141640', 'cui_str': 'Carrots'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",337.0,0.0440557,"Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions.
","[{'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'Nekitsing', 'Affiliation': ''}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Blundell-Birtill', 'Affiliation': ''}, {'ForeName': 'Jennie E', 'Initials': 'JE', 'LastName': 'Cockroft', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Fildes', 'Affiliation': ''}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Hetherington', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.017']
1015,31784929,"Evaluation of bradykinin, VEGF, and EGF biomarkers in gingival crevicular fluid and comparison of PhotoBioModulation with conventional techniques in periodontitis: a split-mouth randomized clinical trial.","Periodontal disease is a chronic progressive inflammatory process leading to damage of tooth-supporting tissues. This comparative study assessed the effect of PhotoBioModulation (PBM) versus conventional therapy, and investigated biomarkers involved in the healing process. The test group comprised twenty systemically-healthy non-smoking subjects with chronic periodontitis with the presence of two matched contro-lateral premolar sites (probing depth > 5 mm); twenty subjects without chronic periodontitis (CP) served as control group. Patients were treated at baseline, either with scaling and root planing (SRP group) or with a procedure entailing SRP supported by PBM (PBM group). The laser used was a diode laser operating at 645 nm wavelength, 10 J/cm2, and 0.5 W/cm2 with a 600 μm fiber optic. Crevicular fluid levels of bradykinin (BK), vascular endothelial growth factor (VEGF), and epidermal growth factor z (EGF) were determined at both sites. Crevicular fluid specimens from both groups were analyzed with the ELISA TEST. Clinical differences in analyzed outcomes were observed in favor of PBM treatment. Taking average values as 100%, the reduction in BK concentration was 47.68% with SRP and 68.43% with PBM on day 3; the VEGF concentration decreased by 35.73% with SRP and 48.59% with PBM on day 7; the EGF concentration increased by 55.58% with SRP and by 58.11% with PBM on day 21.Clinical parameters improved significantly in both groups (pooled mean values of probing depth decreased from 5.6 to 4.5 mm; gingival index from 1.92 to 1.1; and bleeding on probing from 49.67 to 23.23) but did not vary significantly between the PBM and the SRP group. The results confirmed that PBM have beneficial effects in the early phases of the healing process playing a role in modulation of BK, EGF, and VEGF in gingival crevicular fluid levels; both groups had significant clinical improvement over control but there was no significant difference between them, only a trend for PBM group. The overall results of the study suggest a potential benefit of PBM in conjunction with SRP in treating chronic periodontitis.",2020,Clinical differences in analyzed outcomes were observed in favor of PBM treatment.,"['periodontitis', 'twenty systemically-healthy non-smoking subjects with chronic periodontitis with the presence of two matched contro-lateral premolar sites (probing depth > 5 mm); twenty subjects without chronic periodontitis (CP) served as control group']","['scaling and root planing (SRP group) or with a procedure entailing SRP supported by PBM (PBM group', 'bradykinin, VEGF, and EGF biomarkers', 'PBM', 'PhotoBioModulation (PBM']","['VEGF concentration', 'EGF concentration', 'gingival index', 'Crevicular fluid levels of bradykinin (BK), vascular endothelial growth factor (VEGF), and epidermal growth factor z (EGF', 'probing depth', 'BK concentration']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0006100', 'cui_str': 'Arg-Pro-Pro-Gly-Phe-Ser-Pro-Phe-Arg'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006100', 'cui_str': 'Arg-Pro-Pro-Gly-Phe-Ser-Pro-Phe-Arg'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",20.0,0.0273185,Clinical differences in analyzed outcomes were observed in favor of PBM treatment.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Angiero', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ugolini', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy. Alessandro.ugolini@unige.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cattoni', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bova', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Blasi', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gallo', 'Affiliation': 'Section of Biostatistics, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Gianguido', 'Initials': 'G', 'LastName': 'Cossellu', 'Affiliation': ""Department of Biomedical, Surgical and Dental Sciences, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Gherlone', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}]",Lasers in medical science,['10.1007/s10103-019-02919-w']
1016,31200893,Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial.,"BACKGROUND


Paediatric vaccination against influenza can result in indirect protection, by reducing transmission to their unvaccinated contacts. We investigated whether influenza vaccination of children would protect them and their household members in a resource-limited setting.
METHODS


We did a cluster-randomised, blinded, controlled study in three villages in India. Clusters were defined as households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study. Households were randomly assigned (1:1) by a computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV) in the beginning of the study; vaccination occurred once a year for 3 years. The primary efficacy outcome was laboratory-confirmed influenza in a vaccinated child with febrile acute respiratory illness, analysed in the modified intention-to-treat population (ie, children who received at least one dose of vaccine, were under surveillance, and had not an influenza infection within 15 days of last vaccine dose). The secondary outcome for indirect effectiveness (surveillance study) was febrile acute respiratory illness in an unvaccinated household member of a vaccine study participant. Data from each year (year 1: November, 2009, to October, 2010; year 2: October, 2010, to October, 2011; and year 3: October, 2011, to May, 2012) were analysed separately. Safety was analysed among all participants who were vaccinated with at least one dose of the vaccine. This trial is registered with ClinicalTrials.gov, number NCT00934245.
FINDINGS


Between Nov 1, 2009, to May 1, 2012, we enrolled 3208 households, of which 1959 had vaccine-eligible children. 1010 households were assigned to IIV3 and 949 households were assigned to IPV. In 3 years, we vaccinated 4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10 813 unvaccinated household contacts. In year 1, influenza virus was detected in 151 (10%) of 1572 IIV3 recipients and 206 (13%) of 1633 of IPV recipients (total IIV3 vaccine efficacy 25·6% [95% CI 6·8-40·6]; p=0·010). In year 2, 105 (6%) of 1705 IIV3 recipients and 182 (10%) of 1814 IPV recipients had influenza (vaccine efficacy 41·0% [24·1-54·1]; p<0·0001). In year 3, 20 (1%) of 1670 IIV3 recipients and 81 (5%) of 1786 IPV recipients had influenza (vaccine efficacy 74·2% [57·8-84·3]; p<0·0001). In year 1, total vaccine efficacy against influenza A(H1N1)pdm09 was 14·5% (-20·4 to 39·3). In year 2, total vaccine efficacy against influenza A(H3N2) was 64·5% (48·5-75·5). Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3. Indirect vaccine effectiveness was statistically significant only in year 3 (38·1% [7·4-58·6], p=0·0197) when influenza was detected in 39 (1%) of 4323 IIV3-allocated and 60 (1%) of 4121 IPV-allocated household unvaccinated individuals. In the IIV3 group, 225 (12%) of 1632 children in year 1, 375 (22%) of 1718 in year 2, and 209 (12%) of 1673 in year 3 had an adverse reaction (compared with 216 [13%] of 1730, 380 [21%] of 1825, and 235 [13%] of 1796, respectively, in the IPV group). The most common reactions in both groups were fever and tenderness at site. No vaccine-related deaths occurred in either group.
INTERPRETATION


IIV3 provided variable direct and indirect protection against influenza infection. Indirect protection was significant during the year of highest direct protection and should be considered when quantifying the effect of vaccination programmes.
FUNDING


US Centers for Disease Control and Prevention.",2019,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","['1010 households were assigned to IIV3 and 949 households were assigned to', '4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10\u2008813 unvaccinated household contacts', 'enrolled 3208 households, of which 1959 had vaccine-eligible children', 'households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study', 'children would protect them and their household members in a resource-limited setting', 'rural India', 'participants who were vaccinated with at least one dose of the vaccine', 'three villages in India']","['inactivated trivalent influenza vaccine', 'IPV', 'computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV']","['Efficacy', 'Indirect vaccine effectiveness', 'febrile acute respiratory illness', 'Total vaccine efficacy', 'total vaccine efficacy', 'deaths', 'Safety', 'adverse reaction']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C0770694'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",3208.0,0.452958,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","[{'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Sullender', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Center for Global Health, School of Public Health, University of Colorado Denver, Denver, CO, USA. Electronic address: wayne.sullender@ucdenver.edu.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Community Ophthalmology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Debjani', 'Initials': 'D', 'LastName': 'Ram Purakayastha', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Raghuram', 'Initials': 'R', 'LastName': 'Srungaram Vln', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Palomeque', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gargiullo', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Broor', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30079-8']
1017,31770139,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
1018,31782930,Cardiorespiratory fitness and muscular endurance responses immediately and 2 months after a whole-body Tabata or vigorous-intensity continuous training intervention.,"Young adults (52 females, 16 males; age = 21 ± 3 years;  V̇ O 2peak : 41 ± 6 mL/(kg·min)) were randomized into 3 groups: ( i ) no-exercise control (CTL;  n  = 15), ( ii ) Tabata ( n  = 27), or ( iii ) vigorous-intensity continuous training (VICT;  n  = 26) groups for a 4-week supervised training period (4 sessions/week).  V̇ O 2peak , time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance were assessed at baseline, post-training (POST), and 2-month follow-up (FU). Response confidence intervals (CI) were used to classify individuals as likely responders (R; CI > 0). Both exercise interventions increased TTF and TT at POST (both  p  < 0.01), but these benefits were maintained at FU after VICT only ( p  < 0.01). Push-up performance was increased at POST and FU (both  p  < 0.01) after Tabata. VICT resulted in a greater proportion of TTF R versus both groups at POST (CTL: 1/15; VICT: 19/26; Tabata: 9/27) and versus Tabata at FU (3/15; 13/26; 4/27). VICT also had a greater proportion of TT R versus CTL at POST (2/15; 17/26; 10/27). Tabata had a greater proportion of R for maximum push-up repetitions versus both groups at POST (3/15; 6/26; 18/27) and versus CTL at FU (2/15; 10/26; 18/27). Collectively, VICT appears to be more effective for improving cardiorespiratory fitness, whereas whole-body Tabata confers larger improvements in push-up performance following short-term training.  Novelty:  Vigorous-intensity continuous training elicits larger improvements in cardiorespiratory fitness versus whole-body Tabata. Individual response profiles parallel group-level changes in cardiorespiratory fitness and muscular endurance.",2020,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"['Young adults (n=68 [52 F]; age=21±3 y; VO2peak: 41±6 mL/kg/min', 'n=15), Tabata (n=26), or']","['vigorous-intensity continuous training (VICT; n=27) group for a four-week supervised training period', 'VICT', 'whole-body Tabata or vigorous-intensity continuous training intervention', 'no-exercise control (CTL']","['Cardiorespiratory fitness and muscular endurance responses', 'proportion of TTF R', 'cardiorespiratory fitness and muscular endurance', 'Response confidence intervals (CI', 'cardiorespiratory fitness', 'VO2peak, time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance', 'TTF and TT at POST', 'Novelty bullets']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",,0.0254434,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Siemens', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jennifer B L', 'Initials': 'JBL', 'LastName': 'Matusiak', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sawula', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Preobrazenski', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia Okanagan, 1147 Research Road, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0492']
1019,31782931,Blood flow restriction impairs the inflammatory adaptations of strength training in overweight men: a clinical randomized trial.,"The aim of this study was to evaluate the impact of high-intensity strength training (ST) or low-intensity strength training with blood flow restriction (ST-BFR) on monocyte subsets, the expression of C-C chemokine receptor 5 (CCR5), and CD16 on monocytes, and tumor necrosis factor alpha (TNF-α) production of overweight men. Thirty overweight men were randomly assigned to conventional ST or ST-BFR. Both groups performed exercises of knee extension and biceps curl with equal volume (3 sessions/week) over 8 weeks, and the peripheral frequency of monocytes (CD14+CD16-, classical monocytes; CD14+CD16+, intermediate monocytes; CD14-CD16+, nonclassical monocytes), the mean fluorescence intensity (MFI) of CCR5 and CD16 on CD14+ monocytes; and the production of TNF-α by lipopolysaccharide (LPS)-stimulated cells were quantified. Eight weeks of ST increased the frequency of CD14+CD16- monocytes ( p  = 0.04) and reduced the percentage of CD14-CD16+ ( p  = 0.02) and the production of TNF-α by LPS-stimulated cells ( p  = 0.03). The MFI of CD16 on CD14+ monocytes decreased after the ST intervention ( p  = 0.02). No difference in monocyte subsets, CCR5 or CD16 expression, and TNF-α production were identified after ST-BFR intervention ( p  > 0.05). The adoption of ST promotes anti-inflammatory effects on monocyte subsets of overweight men, but this effect was lost when BFR was adopted.  Novelty  High-intensity strength training reduces the production of TNF-α and the peripheral frequency of CD16+ monocytes in overweight men. Blood flow restriction method blunts the strength training adaptations on monocyte subsets and pro-inflammatory TNF-α production in overweight men.",2020,"No difference in monocyte subsets, CCR5 or CD16 expression and TNF-α production were identified after ST-BFR intervention (p>0.05).","['overweight men', '30 overweight men']","['strength training', 'Blood flow restriction', 'high-intensity strength training (ST) or low-intensity strength training with blood flow restriction (ST-BFR', 'conventional ST or ST-BFR', 'High intensity strength training', 'ST']","['monocyte subsets, the expression of C-C Chemokine Receptor 5 (CCR5) and CD16 on monocytes, and tumor necrosis factor-alpha (TNF-α) production', 'mean fluorescence intensity (MFI) of CCR5 and CD16 on CD14+ monocytes; and the production of TNF-α by lipopolysaccharide (LPS)-stimulated cells', 'monocyte subsets and pro-inflammatory TNF-α production', 'frequency of CD14+CD16- monocytes', 'monocyte subsets, CCR5 or CD16 expression and TNF-α production', 'production of TNF-α and the peripheral frequency of CD16+ monocytes', 'MFI of CD16 on CD14+ monocytes', 'percentage of CD14-CD16', 'Novelty •']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0282552', 'cui_str': 'C-C Chemokines'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0033268'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",30.0,0.0117553,"No difference in monocyte subsets, CCR5 or CD16 expression and TNF-α production were identified after ST-BFR intervention (p>0.05).","[{'ForeName': 'Igor Martins', 'Initials': 'IM', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Maeli Andressa', 'Initials': 'MA', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Simone Lunelli', 'Initials': 'SL', 'LastName': 'Galvão', 'Affiliation': 'Research Center. Methodist University Center IPA. Porto Alegre, RS 90420-060, Brazil.'}, {'ForeName': 'Gilson P', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Motricity Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP 19060-90, Brazil.'}, {'ForeName': 'Pedro R T', 'Initials': 'PRT', 'LastName': 'Romão', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0700']
1020,31342474,19 G aspiration needle versus 19 G core biopsy needle for endoscopic ultrasound-guided liver biopsy: a prospective randomized trial.,"BACKGROUND


Endoscopic ultrasound-guided liver biopsy (EUS-LB) is a safe and effective method for accomplishing parenchymal liver biopsy. The aim of this study was to compare a 19 G aspiration needle (FNA) with a 19 G Franseen-tip core biopsy needle (FNB) for EUS-LB.
METHODS


This was a prospective, parallel group, randomized trial comparing the tissue yields and adequacy of a 19 G FNA needle vs. a 19 G FNB needle for EUS-LB. The primary outcome was length of the longest piece of liver core specimen. Secondary outcomes were aggregate specimen length, number of complete portal triads (CPTs), and adverse events. One transgastric pass and one transduodenal pass were performed with the same needle in each patient. Specimen lengths were measured before and after histological processing.
RESULTS


40 patients referred for EUS-LB were randomized to either the FNA group (n = 20) or the FNB group (n = 20). Both groups had similar patient characteristics. FNB biopsies yielded longer mean (standard deviation) specimen lengths (pre-processing mean 2.09 cm [0.41] vs. mean 1.47 cm [0.46], and post-processing mean 1.78 cm [0.66] vs. mean 1.05 cm [0.42]; both  P  < 0.001), a longer aggregate specimen length (pre-processing mean 15.78 cm [5.19] vs. 10.89 cm [4.38];  P  = 0.003), and more CPTs (mean 42.6 25 vs 18.1 [9.3];  P  < 0.001) compared with the FNA needle. There were no severe adverse events or difference in adverse event rate between the two needles. Post-biopsy pain was noted in 37.5 %.
CONCLUSION


EUS-LB using the FNB needle delivered longer liver biopsy specimens with more CPTs than the regular (non-core) needle.",2019,"FNB biopsies yielded longer mean (standard deviation) specimen lengths (pre-processing mean 2.09 cm [0.41] vs. mean 1.47 cm [0.46], and post-processing mean 1.78 cm [0.66]",['40 patients referred for EUS-LB'],"['19\u200aG FNA needle vs. a 19\u200aG FNB needle for EUS-LB', '19\u200aG aspiration needle versus 19\u200aG core biopsy needle for endoscopic ultrasound-guided liver biopsy', 'FNA', 'FNB', '19 G aspiration needle (FNA) with a 19 G Franseen-tip core biopsy needle (FNB', 'Endoscopic ultrasound-guided liver biopsy (EUS-LB']","['CPTs', 'severe adverse events', 'adverse event rate', 'Post-biopsy pain', 'Specimen lengths', 'aggregate specimen length, number of complete portal triads (CPTs), and adverse events', 'longer aggregate specimen length', 'length of the longest piece of liver core specimen']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0470539', 'cui_str': '19G'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0619485', 'cui_str': 'A 19'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle (physical object)'}, {'cui': 'C1289798', 'cui_str': 'Core biopsy needle'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}]","[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0227514', 'cui_str': 'Portal triad structure'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",40.0,0.0667667,"FNB biopsies yielded longer mean (standard deviation) specimen lengths (pre-processing mean 2.09 cm [0.41] vs. mean 1.47 cm [0.46], and post-processing mean 1.78 cm [0.66]","[{'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Ching-Companioni', 'Affiliation': 'Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Diehl', 'Affiliation': 'Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States.'}, {'ForeName': 'Amitpal S', 'Initials': 'AS', 'LastName': 'Johal', 'Affiliation': 'Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Confer', 'Affiliation': 'Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States.'}, {'ForeName': 'Harshit S', 'Initials': 'HS', 'LastName': 'Khara', 'Affiliation': 'Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States.'}]",Endoscopy,['10.1055/a-0956-6922']
1021,31350122,Quantifying the Protective Effects of Stimulants on Functional Outcomes in Attention-Deficit/Hyperactivity Disorder: A Focus on Number Needed to Treat Statistic and Sex Effects.,"PURPOSE


The aim of the study was to help quantify the protective effects of stimulant treatment on important functional outcomes in attention-deficit/hyperactivity disorder (ADHD) using the number needed to treat (NNT) statistic and examine whether these effects are moderated by sex.
METHODS


Subjects were derived from three independent samples, two similarly designed case-control, 10-year prospective follow-up studies of boys and girls with and without ADHD grown up and a cross-sectional randomized clinical trial of lisdexamfetamine on driving performance and behavior. For all studies, subjects were evaluated with structured diagnostic interviews. To measure psychopharmacologic treatment in the follow-up studies, we collected information about each subject's stimulant medication use, age at onset, and age at termination of treatment. Subjects in the driving study underwent two driving simulation assessments (premedication and after 6 weeks of treatment on lisdexamfetamine or placebo). For each outcome, we ran a logistic regression model that included an interaction between sex and treatment status. Lifetime rates were used to calculate the NNT statistic. We also calculated adjusted NNT statistics that accounted for sex, age, socioeconomic status, and family intactness.
RESULTS


The NNTs were very low, ranging from 3 to 10. No interaction effects with sex were detected (all p > .05). The adjusted NNTs mostly remained the same with the exception of any substance use disorder, which increased after controlling for age.
CONCLUSIONS


Stimulants have strong protective effects on functional outcomes in youth with ADHD that are not moderated by sex. These results support the critical importance of early identification and treatment of children with ADHD of both sexes.",2019,"The adjusted NNTs mostly remained the same with the exception of any substance use disorder, which increased after controlling for age.
","['youth with ADHD', 'Attention-Deficit/Hyperactivity Disorder', 'children with ADHD of both sexes', 'attention-deficit/hyperactivity disorder (ADHD', 'Subjects were derived from three independent samples, two similarly designed case-control, 10-year prospective follow-up studies of boys and girls with and without ADHD grown up and a cross-sectional randomized clinical trial of']","['lisdexamfetamine', 'lisdexamfetamine or placebo', 'Stimulants', 'stimulant treatment']","['Functional Outcomes', 'Lifetime rates']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0487009,"The adjusted NNTs mostly remained the same with the exception of any substance use disorder, which increased after controlling for age.
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Department of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, New York; K.G. Jebsen Centre for Psychiatric Disorders, Department of Biomedicine, University of Bergen, Bergen, Norway.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.05.015']
1022,31471729,Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial.,"IMPORTANCE


Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.
OBJECTIVE


To test the effectiveness of a prediabetes SDM intervention.
DESIGN


Cluster randomized controlled trial.
SETTING


Twenty primary care clinics within a large regional health system.
PARTICIPANTS


Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.
INTERVENTION


Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.
MAIN OUTCOMES AND MEASURES


Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.
RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001).
LIMITATIONS


Absence of DPP supplier participation data for matched patients in usual care clinics.
CONCLUSIONS AND RELEVANCE


A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk.
TRIAL REGISTRATION


This study was registered at clinicaltrails.gov (NCT02384109)).",2019,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","['patients with prediabetes', 'SDM participants (n\xa0=\u2009351) than controls receiving usual care ', 'Overweight/obese adults with prediabetes (BMI\u2009≥\u200924\xa0kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics', 'matched patients in usual care clinics', 'Diabetes Prevention', 'Twenty primary care clinics within a large regional health system']","['Shared decision-making (SDM', 'metformin', 'Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care', 'prediabetes SDM intervention']","['uptake of DPP (≥\u20099 sessions), metformin, or both strategies at 4\xa0months', 'weight loss', 'weight change', 'Uptake of DPP and/or metformin', 'adjusted weight loss', 'uptake of DPP and/or metformin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",20.0,0.044247,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Moin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Turk', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Chon', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Dominick L', 'Initials': 'DL', 'LastName': 'Frosch', 'Affiliation': 'Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Kia Skrine', 'Initials': 'KS', 'LastName': 'Jeffers', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Yelba', 'Initials': 'Y', 'LastName': 'Castellon-Lopez', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Norris', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05238-6']
1023,31782966,A randomized clinical trial of mobile phone motivational interviewing for alcohol use problems in Kenya.,"AIM


To test the effectiveness of a motivational interviewing (MI) intervention using the mobile phone among adults with alcohol use problems.
DESIGN


A randomized clinical trial of mobile MI and standard in-person MI with 1- and 6-month follow-up, including a 1-month waitlist control followed by mobile MI.
SETTING


A primary health center in rural Kenya.
PARTICIPANTS


Three hundred adults screening positive for alcohol use problems were randomized and received immediate mobile MI (n = 89), in-person MI (n = 65) or delayed mobile MI (n = 76) for waiting-list controls 1 month after no treatment, with 70 unable to be reached for intervention.
INTERVENTION AND COMPARATOR


One MI session was provided either immediately by mobile phone, in-person at the health center or delayed by 1 month and then provided by mobile phone.
MEASUREMENTS


Alcohol use problems were repeatedly assessed using the Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT-C. The primary outcome was difference in alcohol score 1 month after no intervention for waiting-list control versus 1 month after MI for mobile MI. The secondary outcomes were difference in alcohol score for in-person MI versus mobile MI one and 6 months after MI.
FINDINGS


For our primary outcome, average AUDIT-C scores were nearly three points higher (difference = 2.88, 95% confidence interval = 2.11, 3.66) for waiting-list controls after 1 month of no intervention versus mobile MI 1 month after intervention. Results for secondary outcomes supported the null hypothesis of no difference between in-person and mobile MI at 1 month (Bayes factor = 0.22), but were inconclusive at 6 months (Bayes factor = 0.41).
CONCLUSION


Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya. Providing mobile motivational interviewing may help clinicians in rural areas to reach patients needing treatment for alcohol use problems.",2020,"CONCLUSION


Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya.","['adults visiting primary care in Kenya', 'Three hundred adults screening positive for alcohol use problems', 'A primary health center in rural Kenya', 'adults with alcohol use problems', 'Alcohol Use Problems in Kenya']","['Mobile Phone Motivational Interviewing', 'mobile motivational interviewing', 'mobile MI and standard in-person MI with 1- and 6-month follow-up, including a one-month waitlist control followed by mobile MI', 'Mobile phone-based motivational interviewing', 'motivational interviewing (MI) intervention', 'immediate mobile MI (n=89), in-person MI (n=65), or delayed mobile MI']","['null hypothesis of no difference between in-person and mobile MI', 'alcohol score for in-person MI vs. mobile MI one and six months after MI', 'alcohol score', 'average AUDIT-C scores', 'Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT-C']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",300.0,0.0830683,"CONCLUSION


Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya.","[{'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Harder', 'Affiliation': 'Departments of Pediatrics and Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Abednego M', 'Initials': 'AM', 'LastName': 'Musau', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Christine W', 'Initials': 'CW', 'LastName': 'Musyimi', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Ndetei', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Victoria N', 'Initials': 'VN', 'LastName': 'Mutiso', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}]","Addiction (Abingdon, England)",['10.1111/add.14903']
1024,30998610,Effects of different strategies on high thrombus burden in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization.,"OBJECTIVE


This study aimed at evaluating efficacy and safety of thrombus aspiration and intracoronary-targeted thrombolysis on coronary thrombus burden in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous catheterization, comparing their effects on myocardial perfusion through index of microcirculatory resistance (IMR) and single-photon emission computed tomography (SPECT).
PARTICIPANTS AND METHODS


From January 2017 to January 2018, STEMI patients with high thrombus burden undergoing primary catheterization were enrolled and randomly assigned to receiving thrombus aspiration (TA group) or intracoronary thrombolysis (IT group). IMR, SPECT, and other conventional measurements were adopted to assess myocardial perfusion. Major adverse cardiovascular events (MACEs) and complications were recorded over a 90-day follow-up and a 12-month follow-up after the procedure.
RESULTS


The study consisted of 38 patients in the IT group and 33 in the TA group. After recanalization, thrombus burden score, corrected thrombolysis in myocardial infarction (TIMI) frame count, the proportion of TIMI myocardial perfusion 3 grade, and IMR in the IT group were significantly better than those of the TA group (P<0.05). During the 90-day follow-up, no difference was observed in cardiac function and MACEs. During the 12-month follow-up, there were significant differences in infarct size of SPECT (18.56±8.56 vs. 22.67±7.66, P=0.046), left ventricular ejection fraction of echocardiography (58.13±5.92 vs. 55.17±5.68, P=0.043), and the composite MACEs between the two groups (P=0.034).
CONCLUSION


Thrombus aspiration and intracoronary-targeted thrombolysis are effective and safe strategies in managing high coronary thrombus burden in STEMI patients. Compared with aspiration, intracoronary-targeted thrombolysis is more beneficial in improving myocardial microcirculation perfusion.",2019,"During the 90-day follow-up, no difference was observed in cardiac function and MACEs.","['ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous catheterization', 'patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization', 'From January 2017 to January 2018, STEMI patients with high thrombus burden undergoing primary catheterization', '38 patients in the IT group and 33 in the TA group']","['thrombus aspiration (TA group) or intracoronary thrombolysis', 'thrombus aspiration and intracoronary-targeted thrombolysis', 'aspiration, intracoronary-targeted thrombolysis']","['Major adverse cardiovascular events (MACEs) and complications', 'infarct size of SPECT', 'composite MACEs', 'left ventricular ejection fraction of echocardiography', 'myocardial microcirculation perfusion', 'cardiac function and MACEs', 'thrombus burden score, corrected thrombolysis in myocardial infarction (TIMI) frame count, the proportion of TIMI myocardial perfusion 3 grade, and IMR']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0452366,"During the 90-day follow-up, no difference was observed in cardiac function and MACEs.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Yanqiang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Wenlu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000743']
1025,31396815,Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial.,"BACKGROUND


Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown.
OBJECTIVE


To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control.
DESIGN


Three-arm pragmatic randomized controlled trial.
PATIENTS


One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit.
INTERVENTIONS


Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text).
MAIN MEASURES


Change in systolic BP during the final 4-month visit compared with baseline.
KEY RESULTS


At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
CONCLUSIONS


Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control.
TRIAL REGISTRATION


clinicaltrials.gov (NCT02778542).",2019,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","['One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12\xa0months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit']","['Electronic Pill Bottles or Bidirectional Text Messaging', 'electronic pill bottles or bidirectional text messaging', 'usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text']","['systolic blood pressure', 'systolic BP', 'blood pressure control', 'Hypertension Medication Adherence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",149.0,0.151629,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. shivan.mehta@uphs.upenn.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05241-x']
1026,28810375,"Processes of change in quality of life, weight self-stigma, body mass index and emotional eating after an acceptance-, mindfulness- and compassion-based group intervention (Kg-Free) for women with overweight and obesity.","This study examined the effectiveness of Kg-Free: an acceptance-, mindfulness- and compassion-based group intervention for women with overweight and obesity at post-treatment and 3-month follow-up and explored the psychological processes that underlie changes in quality of life, weight self-stigma, body mass index and emotional eating at post-treatment. Overall, 53 women completed Kg-Free. At post-treatment and 3-month follow-up, participants reported increased quality of life, mindfulness and self-compassion abilities and decreased weight self-stigma, emotional eating, shame, weight-related experiential avoidance, self-criticism and body mass index. Shame and self-criticism reductions were important mediators of changes in health-related outcomes, whereas weight-related experiential avoidance, mindfulness and self-compassion mediated changes in weight and eating-related outcomes.",2019,"At post-treatment and 3-month follow-up, participants reported increased quality of life, mindfulness and self-compassion abilities and decreased weight self-stigma, emotional eating, shame, weight-related experiential avoidance, self-criticism and body mass index.","['women with overweight and obesity', '53 women completed Kg-Free', 'women with overweight and obesity at post-treatment and 3-month follow-up']","['Kg-Free', 'acceptance-, mindfulness- and compassion-based group intervention (Kg-Free', 'acceptance-, mindfulness- and compassion-based group intervention']","['quality of life, weight self-stigma, body mass index and emotional eating', 'quality of life, mindfulness and self-compassion abilities and decreased weight self-stigma, emotional eating, shame, weight-related experiential avoidance, self-criticism and body mass index', 'weight-related experiential avoidance, mindfulness and self-compassion mediated changes in weight and eating-related outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",53.0,0.0238363,"At post-treatment and 3-month follow-up, participants reported increased quality of life, mindfulness and self-compassion abilities and decreased weight self-stigma, emotional eating, shame, weight-related experiential avoidance, self-criticism and body mass index.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Palmeira', 'Affiliation': '1 CINEICC, University of Coimbra, Portugal.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cunha', 'Affiliation': '1 CINEICC, University of Coimbra, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Pinto-Gouveia', 'Affiliation': '1 CINEICC, University of Coimbra, Portugal.'}]",Journal of health psychology,['10.1177/1359105316686668']
1027,31197264,Health-related quality of life in blood pressure control and blood lipid-lowering therapies: results from the CHIEF randomized controlled trial.,"Our study aimed to explore changes in health-related quality of life (HRQoL) during blood pressure control and blood lipid-lowering therapies. We conducted a 2 × 2 factorial-designed randomized controlled trial in 180 clinical centers in China. At baseline, participants were randomly assigned to an amlodipine + amiloride/hydrochlorothiazide group or an amlodipine + telmisartan group for the blood pressure control treatment and to a statin group or a routine intervention group for the blood lipid-lowering treatment. The allocation ratio was 1:1 for both treatments. Follow-up lasted for 4 years. HRQoL was assessed using the EuroQol five dimensions three levels (EQ-5D-3L) questionnaire every year. Of 13,542 hypertensive patients enrolled in the clinical trial, 9885 were eligible for the analysis. The problems for all dimensions of the EQ-5D-3L descriptive system were slight at baseline and were well preserved in the follow-up period. The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not. Decreases in systolic/diastolic blood pressure and low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were independently correlated with increases in the EQ VAS score and the EQ-5D-3L index. In conclusion, HRQoL is associated with blood pressure/lipid levels but not with specific antihypertensive or lipid-lowering interventions. Blood pressure control and blood lipid-lowering therapies should not be denied to Chinese patients in consideration of their negative effects on quality of life.",2019,"The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not.","['13,542 hypertensive patients enrolled in the clinical trial, 9885 were eligible for the analysis', '180 clinical centers in China']","['amlodipine\u2009+\u2009telmisartan', 'statin group or a routine intervention group for the blood lipid-lowering treatment', 'amlodipine\u2009+\u2009amiloride/hydrochlorothiazide']","['blood pressure/lipid levels', 'systolic/diastolic blood pressure and low-density lipoprotein cholesterol', 'EQ VAS score and the EQ-5D-3L index', 'EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index', 'health-related quality of life (HRQoL', 'high-density lipoprotein cholesterol', 'HRQoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0717400', 'cui_str': 'Amiloride / Hydrochlorothiazide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",13542.0,0.165109,"The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not.","[{'ForeName': 'Ruohua', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong-Qiu', 'Initials': 'HQ', 'LastName': 'Gu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. liwei@mrbc-nccd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0281-z']
1028,31199462,Stratifying drug treatment of cognitive impairments after traumatic brain injury using neuroimaging.,"Cognitive impairment is common following traumatic brain injury. Dopaminergic drugs can enhance cognition after traumatic brain injury, but individual responses are highly variable. This may be due to variability in dopaminergic damage between patients. We investigate whether measuring dopamine transporter levels using 123I-ioflupane single-photon emission computed tomography (SPECT) predicts response to methylphenidate, a stimulant with dopaminergic effects. Forty patients with moderate-severe traumatic brain injury and cognitive impairments completed a randomized, double-blind, placebo-controlled, crossover study. 123I-ioflupane SPECT, MRI and neuropsychological testing were performed. Patients received 0.3 mg/kg of methylphenidate or placebo twice a day in 2-week blocks. Subjects received neuropsychological assessment after each block and completed daily home cognitive testing during the trial. The primary outcome measure was change in choice reaction time produced by methylphenidate and its relationship to stratification of patients into groups with normal and low dopamine transporter binding in the caudate. Overall, traumatic brain injury patients showed slow information processing speed. Patients with low caudate dopamine transporter binding showed improvement in response times with methylphenidate compared to placebo [median change = -16 ms; 95% confidence interval (CI): -28 to -3 ms; P = 0.02]. This represents a 27% improvement in the slowing produced by traumatic brain injury. Patients with normal dopamine transporter binding did not improve. Daily home-based choice reaction time results supported this: the low dopamine transporter group improved (median change -19 ms; 95% CI: -23 to -7 ms; P = 0.002) with no change in the normal dopamine transporter group (P = 0.50). The low dopamine transporter group also improved on self-reported and caregiver apathy assessments (P = 0.03 and P = 0.02, respectively). Both groups reported improvements in fatigue (P = 0.03 and P = 0.007). The cognitive effects of methylphenidate after traumatic brain injury were only seen in patients with low caudate dopamine transporter levels. This shows that identifying patients with a hypodopaminergic state after traumatic brain injury can help stratify the choice of cognitive enhancing therapy.",2019,The cognitive effects of methylphenidate after traumatic brain injury were only seen in patients with low caudate dopamine transporter levels.,"['patients with a hypodopaminergic state after traumatic brain injury', 'patients with low caudate dopamine transporter levels', '16', 'Forty patients with moderate-severe traumatic brain injury and cognitive impairments']","['123I-ioflupane single-photon emission computed tomography (SPECT', 'methylphenidate', 'placebo', 'methylphenidate or placebo']","['choice reaction time', 'fatigue', 'slow information processing speed', 'self-reported and caregiver apathy assessments', 'response times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Plasma Membrane Transport Proteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C1956796', 'cui_str': 'iodine ioflupane'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.488325,The cognitive effects of methylphenidate after traumatic brain injury were only seen in patients with low caudate dopamine transporter levels.,"[{'ForeName': 'Peter O', 'Initials': 'PO', 'LastName': 'Jenkins', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Simoni', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Niall J', 'Initials': 'NJ', 'LastName': 'Bourke', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleminger', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Scott', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Towey', 'Affiliation': 'Department of Nuclear Medicine, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Svensson', 'Affiliation': 'Department of Nuclear Medicine, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Nuclear Medicine, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Maneesh C', 'Initials': 'MC', 'LastName': 'Patel', 'Affiliation': 'Imaging Department, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': 'Institute of Neurology, Division of Clinical Neurology, University College London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Friedland', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hampshire', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Cole', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sharp', 'Affiliation': 'Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, Division of Brain Sciences, Hammersmith Hospital, London, UK.'}]",Brain : a journal of neurology,['10.1093/brain/awz149']
1029,31196813,Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial.,"BACKGROUND


Antibiotic-resistant gonorrhoea represents a global public health threat, and new therapies are needed. We aimed to compare the efficacy and safety of solithromycin, a fourth generation macrolide, with ceftriaxone plus azithromycin for the treatment of gonorrhoea.
METHODS


We did an open-label, multicentre, non-inferiority trial of patients aged 15 years or older with uncomplicated untreated genital gonorrhoea at two sites in Australia and one site in the USA. Patients were randomly assigned (1:1) to receive single dose oral solithromycin 1000 mg or intramuscular ceftriaxone 500 mg plus oral azithromycin 1000 mg. Neisseria gonorrhoeae cultures were obtained at baseline and test of cure (day 7 ± 2). The primary outcome was the proportion of patients with eradication of genital N gonorrhoeae based on culture at test of cure, assessed in the microbiological intention-to-treat (mITT) population, which included all randomly assigned patients who received any dose of study drug and had a positive genital culture for N gonorrhoeae at baseline. Non-inferiority of solithromycin was to be concluded if the lower limit of the 95% CI for the between-group differences was greater than -10%. Safety was analysed in all patients who received any dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02210325.
FINDINGS


Between Sept 3, 2014, and Aug 27, 2015, 262 patients were randomly assigned and 261 received treatment (130 in the solithromycin group and 131 in the ceftriaxone plus azithromycin group). In the mITT population, 99 (80%) of 123 patients in the solithromycin group and 109 (84%) of 129 patients in the ceftriaxone plus azithromycin group had N gonorrhoeae eradication at test of cure (difference -4·0%, 95% CI -13·6 to 5·5), thus solithromycin did not meet the criterion for non-inferiority at the prespecified -10% margin. The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients).
INTERPRETATION


Solithromycin as a single 1000 mg dose is not a suitable alternative to ceftriaxone plus azithromycin as first-line treatment for gonorrhoea. If insufficient duration of solithromycin exposure at the infection site in a subset of individuals was the reason for treatment failures, this might be adequately addressed with dose adjustment. However, any further trials with longer dosing need to consider the potential risk of gastrointestinal effects and liver enzyme elevations.
FUNDING


Cempra Pharmaceuticals.",2019,"The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients).
","['Between Sept 3, 2014, and Aug 27, 2015, 262 patients were randomly assigned and 261 received treatment (130 in the solithromycin group and 131 in the', 'uncomplicated genital gonorrhoea (SOLITAIRE-U', 'patients aged 15 years or older with uncomplicated untreated genital gonorrhoea at two sites in Australia and one site in the USA']","['solithromycin', 'solithromycin 1000 mg or intramuscular ceftriaxone 500 mg plus oral azithromycin', 'Solithromycin versus ceftriaxone plus azithromycin', 'ceftriaxone plus azithromycin']","['Neisseria gonorrhoeae cultures', 'diarrhoea', 'N gonorrhoeae eradication', 'frequency of adverse events', 'proportion of patients with eradication of genital N gonorrhoeae based on culture at test of cure, assessed in the microbiological intention-to-treat (mITT) population', 'efficacy and safety', 'nausea', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C3655918', 'cui_str': '(3AR,4R,7S,9R,10R,11R,13R,15R,15AR)-1-(4-(4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-trideoxy-(dimethylamino)-'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0326603', 'cui_str': 'Solitaire (organism)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3655918', 'cui_str': '(3AR,4R,7S,9R,10R,11R,13R,15R,15AR)-1-(4-(4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-trideoxy-(dimethylamino)-'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C1294230', 'cui_str': 'Neisseria gonorrhoeae culture (procedure)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",262.0,0.381666,"The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients).
","[{'ForeName': 'Marcus Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: mchen@mshc.org.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McNulty', 'Affiliation': 'Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Avery', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA; School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Whiley', 'Affiliation': ""Queensland Children's Medical Research Institute, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Sepehr N', 'Initials': 'SN', 'LastName': 'Tabrizi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Dwight', 'Initials': 'D', 'LastName': 'Hardy', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stat, Guerneville, CA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nenninger', 'Affiliation': 'Cempra Pharmaceuticals, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Hocking', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia; Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oldach', 'Affiliation': 'Cempra Pharmaceuticals, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30116-1']
1030,31188278,"Type-specific HPV prevalence, incident cases, persistence and associated pregnancy outcomes among HIV-infected women in Kenya.","BACKGROUND


Persistent infection with high-risk types of human papillomavirus (HPV) is the pre-eminent factor driving the development of cervical cancer. There are large gaps in knowledge about both the role of pregnancy in the natural history of HPV infection, and the impact of HPV on pregnancy outcomes.
METHODS


This single-site prospective cohort sub-study, nested within an international multi-site randomized controlled trial, assessed prevalence, incident cases and persistence of type-specific HPV infection, and the association between persistence of high-risk HPV infection with pregnancy outcomes among HIV-infected pregnant women in Kenya, including HIV transmission to infants. Type-specific HPV was assessed using a line probe assay in pregnancy and again at 3 months after delivery. HIV status of children was determined using PCR at 6 weeks.
RESULTS


In total, 84.1% of women (206/245) had a high-risk HPV infection at enrolment. Three quarters of these infections persisted postpartum (157/206). Persistence of HPV16 and/or HPV18 types was observed in over half (53.4%; 39/73) of women with this infection at enrolment. Almost two-thirds had an incident high-risk HPV infection postpartum, which was not present in pregnancy (62.5%), most commonly HPV52 (19.0%). After adjustments, no association was detected between persistent high-risk HPV and preterm birth. All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
CONCLUSIONS


High levels of high-risk HPV infection and type-specific persistence were documented, heightening the urgency of mass role out of HPV vaccination. The association between HPV persistence and HIV transmission is a novel finding, warranting further study.",2019,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","['HIV-infected pregnant women in Kenya, including HIV transmission to infants', 'HIV-infected women in Kenya']",['HPV16'],"['persistent high-risk HPV and preterm birth', 'incident high-risk HPV infection postpartum', 'persistent HR-HPV infection', 'high-risk HPV infection']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.164114,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vyankandondera', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Wambua', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Irungu', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Mandaliya', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Vanden Broeck', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Verhelst', 'Affiliation': 'Ghent University, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001029']
1031,31081281,A multi-centre randomized controlled trial of open vs closed management of the rectal defect after transanal endoscopic microsurgery.,"AIM


Transanal endoscopic microsurgery (TEM) is a technically challenging strategy that allows expanded indications for local excision of rectal lesions. Transluminal suturing is difficult, so open management of the resultant defect is appealing. Expert opinion suggests there is more pain when the defect is left open. The aim of this study was to determine if closure of the defect created during full thickness excision of rectal lesions with TEM leads to less postoperative pain compared to leaving the defect open.
METHOD


At the time of surgery, patients undergoing a full thickness TEM were randomized to sutured (TEM-S) or open (TEM-O) management of the rectal defect. At five Canadian academic colorectal surgery centres, experienced TEM surgeons enrolled patients ≥ 18 years treated by full thickness TEM. The primary outcome was postoperative pain measured by the visual analogue scale. Secondary outcomes included postoperative pain medication use and 30-day postoperative complications, including bleeding, infection and hospital readmission.
RESULTS


Between March 2012 and October 2013, 50 patients were enrolled and randomized to sutured (TEM-S, n = 28) or open (TEM-O, n = 22) management of the rectal defect. There was no difference between the two study groups in postoperative pain on postoperative day 1 (2.8 vs 2.6, P = 0.76), day 3 (2.8 vs 2.1, P = 0.23) and day 7 (2.8 vs 1.7, P = 0.10).
CONCLUSION


In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.",2019,"In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.","['Between March 2012 and October 2013, 50 patients were enrolled and randomized to', 'patients undergoing a full thickness TEM', 'patients having a full thickness excision with TEM', 'At five Canadian academic colorectal surgery centres, experienced TEM surgeons enrolled patients ≥']","['sutured (TEM-S) or open (TEM-O) management of the rectal defect', 'TEM', 'Transluminal suturing', 'full thickness TEM', 'sutured (TEM-S, n\xa0=\xa028) or open (TEM-O, n\xa0=\xa022', 'transanal endoscopic microsurgery', 'Transanal endoscopic microsurgery (TEM']","['postoperative pain', 'postoperative pain measured by the visual analogue scale', 'postoperative pain medication use and 30-day postoperative complications, including bleeding, infection and hospital readmission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0522520', 'cui_str': 'Transluminal approach (qualifier value)'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C4042939', 'cui_str': 'Transanal Endoscopic Microsurgery'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",50.0,0.128426,"In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.","[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Brown', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hochman', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Raval', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': 'Department of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Phang', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bouchard', 'Affiliation': 'Department of Surgery, CHU de Québec - Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Drolet', 'Affiliation': 'Department of Surgery, CHU de Québec - Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boushey', 'Affiliation': 'Department of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14689']
1032,10841126,"Cardiotocography only versus cardiotocography plus PR-interval analysis in intrapartum surveillance: a randomised, multicentre trial. FECG Study Group.","BACKGROUND


There is a need to improve the sensitivity and specificity of fetal monitoring during labour. We compared the gold standard, cardiotocography, with cardiotocography plus time-interval analysis of the fetal electrocardiogram in fetal surveillance. The aim was to find out whether time-interval analysis decreased the need for operative intervention due to fetal distress.
METHODS


We did a randomised, prospective trial in five hospitals in the UK, Hong Kong, the Netherlands, and Singapore. 1038 women undergoing high-risk labours were randomly assigned fetal monitoring by cardiotocography alone, or cardiotocography plus fetal electrocardiography (ECG). Outcomes measured were rates of operative intervention, and neonatal outcome. Analysis was by intention to treat.
FINDINGS


515 women were assigned management by cardiotocography, and 523 cardiotocography plus fetal ECG. There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17). There was no significant difference between groups in the proportion of babies who had an umbilical arterial pH of 7.15 or less (51 [11%] vs 49 [11%]; 1.01 [0.7-1.47]), or in the frequency of unsuspected acidaemia (42 [9%] vs 35 [8%]; 1.17 [0.76-1.79]).
INTERPRETATION


The addition of time-interval analysis of the fetal electrocardiogram during labour did not show a significant benefit in decreasing operative intervention. There was no significant difference in neonatal outcome.",2000,"There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17).","['1038 women undergoing high-risk labours', '515 women were assigned management by cardiotocography, and 523', 'five hospitals in the UK, Hong Kong, the Netherlands, and Singapore']","['cardiotocography plus fetal ECG', 'Cardiotocography only versus cardiotocography plus PR-interval analysis', 'gold standard, cardiotocography, with cardiotocography plus time-interval analysis of the fetal electrocardiogram', 'cardiotocography alone, or cardiotocography plus fetal electrocardiography (ECG']","['proportion of babies who had an umbilical arterial pH', 'neonatal outcome', 'fetal distress', 'rates of operative intervention, and neonatal outcome', 'frequency of unsuspected acidaemia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0278336', 'cui_str': 'Fetal electrocardiogram (procedure)'}, {'cui': 'C0520877', 'cui_str': 'PR interval feature'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1623258', 'cui_str': 'ECG'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0268030', 'cui_str': 'Acidemia (disorder)'}]",1038.0,0.286224,"There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17).","[{'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Strachan', 'Affiliation': ""Queen's Medical Centre, Nottingham, UK. bryony.strachan@nottingham.ac.uk""}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'van Wijngaarden', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sahota', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'James', 'Affiliation': ''}]","Lancet (London, England)",[]
1033,30853354,Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial: Design and rationale.,"BACKGROUND


Although extensive substrate modification in addition to pulmonary vein isolation (PVI) has been recommended in catheter ablation for persistent atrial fibrillation (AF), recent randomized controlled trials have not demonstrated efficacy of such additional ablations.
METHODS AND STUDY DESIGN


The Osaka Cardiovascular Conference will conduct a multicenter, randomized, open-label trial aiming to examine whether PVI alone is non-inferior to PVI plus additional ablation such as linear ablation and/or complex fractionated atrial electrogram ablation in patients with persistent AF. The primary outcome is recurrence of AF documented by scheduled or symptom-driven electrocardiogram tests during a 1-year follow-up period after the index ablation. The key secondary endpoints include all-cause death, occurrence of symptomatic stroke, complications related to the procedure, and quality of life assessment using the 36-item Short-Form Health Survey. The clinical impact of the presence or absence of AF trigger foci, and their origins in cases with them, on the results of catheter ablation will also be investigated as an exploratory endpoint. A total of 512 patients will be enrolled and followed up to 1 year.
CONCLUSIONS


The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.",2019,The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.,"['512 patients will be enrolled and followed up to 1 year', 'patients with persistent AF', 'Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial', 'patients with persistent AF undergoing a first catheter ablation']","['PVI alone', 'Extensive Ablation']","['cause death, occurrence of symptomatic stroke, complications related to the procedure, and quality of life assessment using the 36-item Short-Form Health Survey', 'recurrence of AF documented by scheduled or symptom-driven electrocardiogram tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",512.0,0.144063,The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.,"[{'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Nakatani', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Shungo', 'Initials': 'S', 'LastName': 'Hikoso', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Medical Therapeutics for Heart Failure, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: hikoso@cardiology.med.osaka-u.ac.jp.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Keio University, Department of Mathematics, Yokohama, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Egami', 'Affiliation': 'Division of Cardiology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Kashiwase', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiology, Osaka Hospital, Japan Community Healthcare Organization, Osaka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Department of Medical Informatics, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Informatics, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Department of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Suna', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hirota', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Oeun', 'Initials': 'O', 'LastName': 'Bolrathanak', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Okuyama', 'Affiliation': 'Cardiovascular Division, Osaka Minami Medical Center, Kawachinagano, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.01.010']
1034,31029455,Clinical comparative study regarding interrupted and uninterrupted dabigatran therapy during perioperative periods of cryoballoon ablation for paroxysmal atrial fibrillation.,"BACKGROUND


Catheter manipulation in the left-sided heart is known as a risk for cerebral embolisms (CEs). However, anticoagulation therapy is terminated before catheter ablation (CA) of atrial fibrillation (AF) concerning adverse bleeding events. Little is known whether uninterrupted direct oral anticoagulants (DOACs) during perioperative period of CA could render the ablation procedure safer and reduce the incidence of CEs compared to interrupted DOACs. The aim of this study was to investigate the safety and usefulness of uninterrupted dabigatran during the periprocedural period for CA of AF.
METHODS


We included 333 patients with paroxysmal AF undergoing cryoballoon CA (CBA). They were prospectively divided into 2 groups based on whether DOACs were interrupted on the day of the CA (Group A, n=228) or dabigatran was not interrupted throughout perioperative period (Group B, n=105) in a non-randomized fashion. When the Group B patients had taken other DOACs rather than dabigatran before assignment, we changed those DOACs to dabigatran. Brain magnetic resonance imaging (MRI) was undertaken on the following day of the CA. Serious bleeding event cases were excluded from the study.
RESULTS


The baseline characteristics including the CHADs2 score did not exhibit any significant differences between the groups. The brain MRI revealed an acute CEs in 82 patients, and was significantly higher in Group A than B (29% vs. 13%, respectively, p<0.01). There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62).
CONCLUSION


Uninterrupted dabigatran therapy during the CBA of paroxysmal AF could significantly reduce the incidence of CEs.",2019,"There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62).
","['paroxysmal atrial fibrillation', '333 patients with paroxysmal AF undergoing cryoballoon CA (CBA']","['CA', 'dabigatran', 'interrupted and uninterrupted dabigatran therapy', 'Brain magnetic resonance imaging (MRI', 'uninterrupted dabigatran', 'cryoballoon ablation']","['CHADs2 score', 'incidence of CEs', 'bleeding events', 'brain MRI revealed an acute CEs']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C2585876', 'cui_str': 'CHADS2 score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}]",333.0,0.0205759,"There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62).
","[{'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Okishige', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan. Electronic address: okishige@yo.rim.or.jp.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Shigeta', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kurabayashi', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuteru', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Sasano', 'Affiliation': 'Arrhythmia Center, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Arrhythmia Center, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.02.003']
1035,31188229,Effects of Brimonidine and Timolol on the Progression of Visual Field Defects in Open-angle Glaucoma: A Single-center Randomized Trial.,"PRéCIS:: Instillation of brimonidine or timolol slowed visual field deterioration in patients with open-angle glaucoma; both brimonidine and timolol might improve the mean deviation (MD) slopes.
PURPOSE


The purpose of this study was to investigate and compare the effects of 0.1% brimonidine and 0.5% timolol on the progressing visual field defects in open-angle glaucoma.
PATIENTS AND METHODS


We evaluated 1 eye each of 68 glaucoma patients who were treated with at least 1 prostaglandin analog. Their baseline MD slopes were < -0.5 dB/y based on at least 5 Humphrey field analyzer measurements within 3 years. Eligible eyes were randomly assigned to brimonidine or timolol treatment groups and treatments were administered without the wash-out period. Clinical examinations were performed every 4 months for 2 years. We designated the MD slope as the primary endpoint.
RESULTS


Ultimately, 56 eyes (brimonidine:timolol=26:30) were included in the present study (mean age=65.2 y). Dropout rates of brimonidine and timolol treatment groups were 27.8% and 6.3%, respectively. There were no significant differences in baseline intraocular pressure or MD slopes between brimonidine and timolol groups (12.7 and 12.9 mm Hg, P=0.77, and -1.22 and -1.08 dB/y, P=0.43, respectively). Intraocular pressure decreased significantly in the brimonidine group at 4, 8, 12, and 16 months, and in the timolol group at 4 months, without significant differences between the drugs (P=0.20). MD slopes significantly improved in both groups (brimonidine: -0.38 dB/y, P<0.001; timolol: -0.52 dB/y, P=0.04). Furthermore, there was no significant difference between groups in the primary endpoint (P=0.59).
CONCLUSION


Brimonidine and timolol treatments improved MD slopes in open-angle glaucoma.",2019,MD slopes significantly improved in both groups (brimonidine: -0.38 ,"['Open-angle Glaucoma', '68 glaucoma patients who were treated with at least 1 prostaglandin analog', 'Eligible eyes', 'patients with open-angle glaucoma']","['56 eyes (brimonidine', 'Brimonidine and timolol', 'dB', 'brimonidine', 'brimonidine and timolol', 'timolol', 'Brimonidine and Timolol', 'brimonidine or timolol']","['mean deviation (MD) slopes', 'progressing visual field defects', 'baseline intraocular pressure or MD slopes', 'Progression of Visual Field Defects', 'visual field deterioration', 'Dropout rates', 'baseline MD slopes', 'Intraocular pressure', 'MD slopes']","[{'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}]","[{'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]",,0.0414716,MD slopes significantly improved in both groups (brimonidine: -0.38 ,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Public Health, Yamagata University Graduate School of Medical Science, Yamagata.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Departments of Ophthalmology.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Tsuda', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Omodaka', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nakazawa', 'Affiliation': 'Departments of Ophthalmology.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001285']
1036,30895583,Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study.,"BACKGROUND


Pancreatic duct disruption is common and is associated with high morbidity in cases of acute necrotizing pancreatitis (ANP). In this study, we tested the feasibility and safety of prophylactic pancreatic duct stenting (PPDS) in ANP and compared PPDS with conservative treatment.
METHODS


We prospectively enrolled patients (aged 18 - 75 years) diagnosed with ANP between February 2011 and July 2015. These patients were prospectively randomized to receive PPDS or conservative treatment at two tertiary centers. PPDS was performed as soon as possible after randomization.
RESULTS


Concern regarding iatrogenic infections with pancreatic necrosis in the PPDS group prompted interim analysis, which confirmed a highly elevated risk. Thus, the trial was terminated prematurely for ethical reasons. Of the 11 patients in the PPDS group, all patients with successful pancreatic duct placement (5/5, 100 %) presented with infection, compared with only 3 of the 13 patients (23.1 %) in the conservative treatment group ( P  = 0.01). Analysis revealed success rates of 63.6 % for pancreatic duct cannulation, 45.5 % for pancreatic duct stenting, and 18.2 % for placement of a stent bridging the necrosis. Cannulation and stenting failures were due to duodenal edema and pancreatic duct stenosis.
CONCLUSIONS


PPDS in ANP is associated with an unacceptably high risk of pancreatic necrosis infection. In addition, the procedure is technically challenging due to duodenal edema and ductal stenosis.",2019,"Analysis revealed success rates of 63.6 % for pancreatic duct cannulation, 45.5 % for pancreatic duct stenting, and 18.2 % for placement of a stent bridging the necrosis.","['enrolled patients (aged 18\u200a-\u200a75 years) diagnosed with ANP between February 2011 and July 2015', 'severe acute necrotizing pancreatitis']","['prophylactic pancreatic duct stenting (PPDS', 'Prophylactic pancreatic duct stenting', 'PPDS']","['success rates', 'successful pancreatic duct placement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0267941', 'cui_str': 'Pancreatitis, Acute Necrotizing'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0466374,"Analysis revealed success rates of 63.6 % for pancreatic duct cannulation, 45.5 % for pancreatic duct stenting, and 18.2 % for placement of a stent bridging the necrosis.","[{'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Karjula', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Nordblad Schmidt', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Mäkelä', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Janne H', 'Initials': 'JH', 'LastName': 'Liisanantti', 'Affiliation': 'Department of Anesthesiology, Division of Intensive Care Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Saarela', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}]",Endoscopy,['10.1055/a-0865-1960']
1037,32410519,Comparison and evaluation of three techniques for treating auricular pseudocyst.,"Background:  Auricular pseudocyst is a benign cystic lesion in cartilages of the auricle. Different methods are currently used to manage this disease. In these methods, simple aspiration combined with pressure dressing, local steroid injection and surgery are the most prevalent therapies. Objective:  To find the best clinical path for the treatment of auricular pseudocyst. Methods:  Eighty-four subjects were randomly allocated into three equal groups (Group A: simple suction combined with pressure dressing; Group B: suction and local steroid injection; and, Group C: surgery). Two otolaryngologists assessed effective rate, sequelae and degree of satisfaction at three-month follow-up. A visual analog scale was used to determine degree of satisfaction. Results:  Group A had the lowest effective rate (54%). Group C was highest in terms of effectiveness (100%) but also in incidence of sequelae (71%). Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%). Degree of satisfaction was highest (7.0 ± 2.7) for Group B. Conclusion:  Local steroid injection should be the first choice for the treatment of auricular pseudocyst because of high satisfaction, favorable effectiveness and few sequelae. Where this method is ineffective, surgery should be used.",2020,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).",['Eighty-four subjects'],"['simple suction combined with pressure dressing; Group B: suction and local steroid injection', 'Local steroid injection']","['Degree of satisfaction', 'incidence of sequelae', 'lowest effective rate', 'effective rate, sequelae and degree of satisfaction', 'effective rate']","[{'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1289828', 'cui_str': 'Pressure dressing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",84.0,0.0604002,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'The First Faculty of Clinical Medicine, Shandong University of Tradition Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Qianru', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Benling', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'The First Faculty of Clinical Medicine, Shandong University of Tradition Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Chengfang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shudong', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770169']
1038,31178342,"Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.","BACKGROUND


Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial.
METHODS


A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485.
FINDINGS


Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44).
INTERPRETATION


In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease).
FUNDING


Netherlands Organisation for Health Research and Development.",2019,"12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001).","['Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid', 'Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone', ""Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease"", 'Patients with Hinchey I or II diverticulitis were not eligible for inclusion', '133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease', 'Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016', 'eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands']","[""Hartmann's procedure versus sigmoidectomy with primary anastomosis"", ""Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease"", ""Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy"", ""Hartmann's procedure (68 patients) or primary anastomosis""]","['short-term morbidity and mortality', '12-month stoma-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0034573', 'cui_str': 'Radiography, Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0439665', 'cui_str': 'Purulent (morphologic abnormality)'}, {'cui': 'C0473119', 'cui_str': 'Fecal peritonitis (disorder)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.188953,"12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001).","[{'ForeName': 'Daniël P V', 'Initials': 'DPV', 'LastName': 'Lambrichts', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands. Electronic address: d.lambrichts@erasmusmc.nl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vennix', 'Affiliation': 'Department of Radiology, University Medical Centre Amsterdam, VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Gijsbert D', 'Initials': 'GD', 'LastName': 'Musters', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Mulder', 'Affiliation': 'Department of Surgery, Rode Kruis Hospital, Beverwijk, Netherlands.'}, {'ForeName': 'Hilko A', 'Initials': 'HA', 'LastName': 'Swank', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Anton G M', 'Initials': 'AGM', 'LastName': 'Hoofwijk', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'Belgers', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands.'}, {'ForeName': 'Hein B A C', 'Initials': 'HBAC', 'LastName': 'Stockmann', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Quirijn A J', 'Initials': 'QAJ', 'LastName': 'Eijsbouts', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Bart A', 'Initials': 'BA', 'LastName': 'van Wagensveld', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Anna A W', 'Initials': 'AAW', 'LastName': 'van Geloven', 'Affiliation': 'Department of Surgery, Tergooi Hospital, Hilversum, Netherlands.'}, {'ForeName': 'Rogier M P H', 'Initials': 'RMPH', 'LastName': 'Crolla', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Nienhuijs', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Marc J P M', 'Initials': 'MJPM', 'LastName': 'Govaert', 'Affiliation': 'Department of Surgery, Dijklander Hospital, Hoorn, Netherlands.'}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'di Saverio', 'Affiliation': ""Department of Surgery, Maggiore Hospital, Bologna, Italy; Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK.""}, {'ForeName': 'André J L', 'Initials': 'AJL', 'LastName': ""D'Hoore"", 'Affiliation': 'Department of Abdominal Surgery, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Robert E G J M', 'Initials': 'REGJM', 'LastName': 'Pierik', 'Affiliation': 'Department of Surgery, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Kruyt', 'Affiliation': 'Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands.'}, {'ForeName': 'Joost A B', 'Initials': 'JAB', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Willem H', 'Initials': 'WH', 'LastName': 'Steup', 'Affiliation': 'Department of Surgery, Haga Hospital, Den Haag, Netherlands.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Catena', 'Affiliation': 'Department of Surgery, Maggiore Hospital, Parma, Italy.'}, {'ForeName': 'Joop L M', 'Initials': 'JLM', 'LastName': 'Konsten', 'Affiliation': 'Department of Surgery, VieCuri, Venlo, Netherlands.'}, {'ForeName': 'Jefrey', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30174-8']
1039,30712404,An open-label randomized trial of intramuscular olanzapine versus oral clonidine for symptomatic treatment of opioid withdrawal in the emergency department.,"Background:  Patients with opioid withdrawal often present to the Emergency Department (ED), but many EDs do not have the infrastructure in place to initiate treatment with opioid agonists (methadone or buprenorphine). Therefore, ED management often entails symptomatic control. The purpose of this study was to compare olanzapine to clonidine for the treatment of opioid withdrawal symptoms.  Methods:  This was a prospective, randomized clinical trial comparing 10 mg of IM olanzapine to 0.3 mg of oral clonidine for symptoms of opioid withdrawal. Adult (18 years and older) ED patients reporting a history of opioid use and symptoms consistent with withdrawal were eligible. Patients were excluded if they had already received treatment during the ED encounter, were pregnant, incarcerated, or unable to provide consent. Patients were randomized 1:1 to receive olanzapine or clonidine for their initial treatment. A baseline Clinical Opiate Withdrawal Scale (COWS) score was calculated. After 30 min, the patient could receive any additional treatment at the ED physician's discretion. The primary outcome was need for additional medication (rescue) within 1 h of study medication administration. Secondary outcomes included change in COWS score and adverse reactions.  Results:  We enrolled 63 patients (33 olanzapine, 30 clonidine). Demographic characteristics were similar for both groups (median age 45, range 21-67, 54% male) as well as baseline COWS score (median score 11). The median time since last opiate use was 48 h for both groups (range 4-116). Rescue was given within 1 h for olanzapine for 9 (27%) patients and for clonidine in 19 (63%) patients (difference 36%, 95% CI 13-59%). Decrease in COWS score at 1 h was 8.3 for olanzapine and 5.1 for clonidine (difference 3.2, 95% CI 0.3-6). Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  Conclusions:  Treatment of opioid withdrawal symptoms with 10 mg of IM olanzapine results in a lower incidence of rescue medication administration and improved symptoms (COWS score) compared to 0.3 mg of oral clonidine.",2019,"Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  ","['Patients with opioid withdrawal often present to the Emergency Department (ED', 'Patients were excluded if they had already received treatment during the ED encounter, were pregnant, incarcerated, or unable to provide consent', 'symptomatic treatment of opioid withdrawal in the emergency department', '63 patients (33', 'Adult (18 years and older) ED patients']","['olanzapine, 30 clonidine', 'olanzapine or clonidine', 'intramuscular olanzapine', 'opioid agonists (methadone or buprenorphine', 'oral clonidine', 'clonidine', 'olanzapine', 'IM olanzapine']","['baseline Clinical Opiate Withdrawal Scale (COWS) score', 'median time since last opiate use', 'need for additional medication (rescue) within 1\u2009h of study medication administration', 'akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0', 'baseline COWS score', 'COWS score', 'rescue medication administration and improved symptoms (COWS score', 'change in COWS score and adverse reactions', 'Demographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4706547', 'cui_str': 'Clinical Opiate Withdrawal Scale score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",63.0,0.145648,"Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  ","[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Klein', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Jon B', 'Initials': 'JB', 'LastName': 'Cole', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Miner', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'JoAn R', 'Initials': 'JR', 'LastName': 'Laes', 'Affiliation': 'b Minnesota Poison Control System , Minneapolis , MN , USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fagerstrom', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'L Martel', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2018.1547828']
1040,29952075,Photothermal therapy enhanced the effectiveness of imiquimod against refractory cutaneous warts through boosting immune responses.,"Refractory cutaneous warts are difficult to eliminate. In situ photo-immunotherapy (ISPI) is an innovative treatment concept combining local photothermal therapy (PTT) and topical immunotherapy using imiquimod. To compare the efficacy of ISPI vs topical imiquimod alone, a prospective randomized controlled trial was performed with patients suffering from refractory cutaneous warts. In both groups, approximately 50% of the skin surface containing warts was treated for 6 weeks. On the basis of topical imiquimod, ISPI includes an additional 808 nm laser irradiation. Treatment response, temperatures during irradiation and histopathologic examination were evaluated. The complete response rate in the ISPI-group (22/36, 61.1%) was significantly higher than in the imiquimod alone group (11/34, 32.4%). In the ISPI-group, the mean maximum temperature was 44.5 ± 5.1°C, and obvious lymphocytic infiltration was found in the perivasculature of the dermis. There was no recurrence or worsening in both groups during the 12-month follow-up. No obvious adverse reaction was observed. This study demonstrates that ISPI can be used as an effective and safe treatment modality for refractory cutaneous warts.",2019,"The complete response rate in the ISPI-group (22/36, 61.1%) was significantly higher than in the imiquimod alone group (11/34, 32.4%).",['patients suffering from refractory cutaneous warts'],"['ISPI vs topical imiquimod', 'Photothermal therapy', 'ISPI', 'imiquimod', 'situ photo-immunotherapy (ISPI', 'topical imiquimod, ISPI']","['mean maximum temperature', 'obvious lymphocytic infiltration', 'complete response rate', 'recurrence or worsening', 'adverse reaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1262091', 'cui_str': 'Lymphocytic infiltration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0242968,"The complete response rate in the ISPI-group (22/36, 61.1%) was significantly higher than in the imiquimod alone group (11/34, 32.4%).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fuhe', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Degang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Feifan', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Biophotonics Research Laboratory, Center for Interdisciplinary Biomedical Education and Research, College of Mathematics and Science, University of Central Oklahoma, Edmond, Oklahoma, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Stepp', 'Affiliation': 'Laser-Forschungslabor, LIFE Center, University Hospital of Munich, Munich, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Sroka', 'Affiliation': 'Laser-Forschungslabor, LIFE Center, University Hospital of Munich, Munich, Germany.'}, {'ForeName': 'Wei R', 'Initials': 'WR', 'LastName': 'Chen', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}]",Journal of biophotonics,['10.1002/jbio.201800149']
1041,31163319,Attachment-related attention bias plays a causal role in trust in maternal support.,"The current study was designed to test whether children's ability to flexibly shift their attention (from their mother during distress to peers during exploration and vice versa) causally increases children's trust in the mother's support. We trained attention flexibility using a gaze-contingent music reward design. A total of 85 children (9-13 years of age; 46% boys) were randomly assigned to this training or a comparable yoked control condition. Attentional preferences were measured via eye tracking. Before and after the manipulation, we measured self-reported trust. Results showed that the training condition increased children's attention flexibility. Training-related increased attentional focus on the mother during distress was linked with increased trust.",2019,Training-related increased attentional focus on the mother during distress was linked with increased trust.,['85 children (9-13\u202fyears of age; 46% boys'],[],"['Attentional preferences', ""children's attention flexibility""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]",[],"[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",85.0,0.0268242,Training-related increased attentional focus on the mother during distress was linked with increased trust.,"[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Bosmans', 'Affiliation': 'Parenting and Special Education Research Group, KU Leuven, 3000 Leuven, Belgium. Electronic address: guy.bosmans@kuleuven.be.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, 9000 Gent, Belgium; Department of Clinical Psychology, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Finet', 'Affiliation': 'Parenting and Special Education Research Group, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, 9000 Gent, Belgium.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.017']
1042,31758324,Effects of a nutrition intervention on acute and late bowel symptoms and health-related quality of life up to 24 months post radiotherapy in patients with prostate cancer: a multicentre randomised controlled trial.,"PURPOSE


Radiotherapy to the prostate gland and pelvic lymph nodes may cause acute and late bowel symptoms and diminish quality of life. The aim was to study the effects of a nutrition intervention on bowel symptoms and health-related quality of life, compared with standard care.
METHODS


Patients were randomised to a nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet. Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods were assessed up to 24 months after radiotherapy completion. Multiple linear regression was used to analyse the effects of the nutrition intervention on bowel symptoms during the acute (up to 2 months post radiotherapy) and the late (7 to 24 months post radiotherapy) phase.
RESULTS


Most symptoms and functioning worsened during the acute phase, and improved during the late phase in both the intervention and standard care groups. The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029). However, these associations were clinically trivial or small.
CONCLUSIONS


The effect of the nutrition intervention related to dietary fibre and lactose on bowel symptoms from pelvic RT was small and inconclusive, although some minor and transient improvements were observed. The results do not support routine nutrition intervention of this type to reduce adverse effects from pelvic radiotherapy.",2020,"The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029).","['Patients', 'patients with prostate cancer']","['nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet', 'radiotherapy', 'nutrition intervention']","['bowel symptoms', 'bowel symptoms and health-related quality of life', 'acute and late bowel symptoms and health-related quality of life', 'loss of appetite', 'flatulence', 'Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods', 'blood in stools']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3661726', 'cui_str': 'Insoluble dietary fiber'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1321898', 'cui_str': 'Bloody stool'}]",,0.0473045,"The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Forslund', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. marina.forslund@igp.uu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ottenblad', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Department of Clinical Oncology, Central Hospital, Karlstad, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nygren', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05182-5']
1043,31374188,"Medroxyprogesterone acetate concentrations among HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi.","OBJECTIVE


To compare medroxyprogesterone acetate (MPA) concentrations between HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot medroxyprogesterone (DMPA) injectable.
STUDY DESIGN


Secondary analysis of 28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women randomized to initiate DMPA in a clinical trial of progestin contraception in Malawi.
RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
CONCLUSIONS


Antiretroviral medications may affect MPA metabolism in HIV-positive African women.",2019,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","['28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women', 'HIV-positive African women', 'HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot', 'HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi']","['medroxyprogesterone (DMPA', 'DMPA', 'progestin contraception', 'medroxyprogesterone acetate (MPA', 'Medroxyprogesterone acetate']","['MPA concentrations', 'MPA metabolism']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-para-anisidine'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",28.0,0.386095,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","[{'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Zia', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA; Association of Schools and Programs of Public Health, Washington, DC. Electronic address: yaszia@gmail.com.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina- Chapel Hill, School of Medicine, Chapel Hill, NC; UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Tegha', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA.'}]",Contraception,['10.1016/j.contraception.2019.07.144']
1044,31620980,"Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab.","ABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer. ABP 980 is approved in the United States, European Union, and Japan for all the indications of trastuzumab, based on the totality of evidence (TOE) gathered by the systematic step-wise accumulation of comparative analytical, preclinical, and clinical (pharmacokinetics [PK], efficacy, safety and immunogenicity) data for ABP 980 and trastuzumab reference product (RP). As a key first step of the ABP 980 biosimilar program, comprehensive analytical characterization of critical quality attributes established that ABP 980 is structurally and functionally similar to trastuzumab RP. Complementing these data, results of non-clinical pharmacology, toxicology, and toxicokinetic studies supported similarity between ABP 980 and trastuzumab RP. A randomized study in healthy subjects demonstrated clinical PK equivalence of ABP 980 relative to trastuzumab RP in these subjects. In the final clinical evaluation step, a randomized comparative study (LILAC) confirmed the lack of clinically meaningful differences between ABP 980 and trastuzumab RP in efficacy, safety, and immunogenicity in women with HER2-positive EBC in the neoadjuvant-adjuvant setting. Neoadjuvant EBC represented a sensitive homogenous population for biosimilar demonstrations, and the primary endpoint of pathologic complete response served as a sensitive surrogate endpoint. An important aspect of the LILAC study design is that it is the only study that evaluated the effect of switching from the trastuzumab RP to a trastuzumab biosimilar during the adjuvant phase. No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab. Overall, the TOE data generated for ABP 980 support the conclusion that it is highly similar to trastuzumab RP, thus providing the scientific justification for extrapolation to all the approved indications of trastuzumab.",2019,"No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab.","['HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer', 'healthy subjects', 'women with HER2-positive EBC in the neoadjuvant-adjuvant setting']",[],"['efficacy, safety, and immunogenicity', 'clinical PK equivalence']","[{'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",980.0,0.021034,"No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab.","[{'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Kolberg', 'Affiliation': 'Marienhospital Bottrop GmbH, Josef-Albers-Str. 70, 46236, Bottrop, Germany. hans-christian.kolberg@mhb-bottrop.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Santi', 'Affiliation': 'Centro de Estudos de Hematologia e Oncologia, São Paulo, Brazil.'}, {'ForeName': 'Georgia Savva', 'Initials': 'GS', 'LastName': 'Demetriou', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Segui-Palmer', 'Affiliation': 'Corporació Sanitària Parc Taulí, Sabadell, Spain.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA, 90404, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc, 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}]",Targeted oncology,['10.1007/s11523-019-00675-z']
1045,31760819,Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.,"BACKGROUND


Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial.
METHODS


Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility.
RESULTS


Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%;  P =0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients.
CONCLUSIONS


The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.",2019,The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF.,"['patients with AF and advanced HF', 'patients with HF', 'Congestive Heart Failure With Ablation', 'Patients with persistent/longstanding persistent AF and LVEF ≤35', '68 and 72 patients', 'Patients With Persistent Atrial Fibrillation and Congestive Heart Failure', '140 patients (65±8 years, 126 [90%] men) available for the end point analysis', 'patients with seriously advanced HF', 'patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF']","['catheter ablation of AF', 'catheter ablation of AF or best medical therapy (BMT', 'Catheter Ablation Versus Best Medical Therapy', 'cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted']","['LVEF', '12-lead electrocardiograms', 'absolute increase in LVEF', 'Sinus rhythm', '6-minute walk test, quality-of-life, and NT-proBNP', 'rate or rhythm control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",140.0,0.127378,The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF.,"[{'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany (K.-H.K., R.R.T.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis Medical University, Budapest, Hungary (B.M., L.G.).'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': 'Heart Center, Ludwigshafen, Germany (R.Z.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Arentz', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Germany (T.A.).'}, {'ForeName': 'Karlheinz', 'Initials': 'K', 'LastName': 'Seidl', 'Affiliation': 'Klinikum Ingolstadt GmbH, Ingolstadt, Germany (K.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schlüter', 'Affiliation': 'Asklepios Proresearch, Hamburg (M.S.).'}, {'ForeName': 'Roland Richard', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany (K.-H.K., R.R.T.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Piorkowski', 'Affiliation': 'Heart Center, University of Leipzig (C.P., G.H.).'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Gellér', 'Affiliation': 'Semmelweis Medical University, Budapest, Hungary (B.M., L.G.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kleemann', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Heart Center, University of Leipzig (C.P., G.H.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007731']
1046,25797743,Preliminary results from a prospective trial of preoperative combined BRAF and MEK-targeted therapy in advanced BRAF mutation-positive melanoma.,"BACKGROUND


We conducted a prospective trial of BRAF and mitogen-activated protein kinase kinase (MEK) targeted therapy in advanced, operable BRAF mutation-positive melanoma to determine feasibility, tumor response rates, and biomarkers of response and resistance.
STUDY DESIGN


Thirteen patients with locally or regionally advanced BRAF mutation-positive melanoma received dabrafenib 150 mg po bid for 14 days, followed by dabrafenib plus trametinib 2 mg po daily for 14 days before operation. Biopsies and tumor measurements were obtained at baseline and days 14 and 28. Formalin-fixed paraffin embedded specimens were analyzed with hematoxylin and eosin, Ki-67, cleaved caspase-3, CD8, phosphorylated extracellular signal-regulated kinase (ERK), and phosphorylated MEK immunostains.
RESULTS


Therapy was tolerated well, with toxicity ≥ grade 3 in 2 of 13 (15%) patients. All 12 patients receiving >14 days of therapy had substantial reduction in tumor volume (65% at day 14 and 78% at day 28) and underwent resection. After 14 days of dabrafenib therapy, there was a marked reduction in viable melanoma cells and a CD8 T-cell--rich infiltrate. Proliferation of the residual melanoma cells was reduced and apoptosis was increased. The cells continued to express phosphorylated ERK and phosphorylated MEK consistent with incomplete mitogen-activated protein kinase pathway inhibition.
CONCLUSIONS


Preoperative targeted therapy of advanced BRAF-mutant melanoma is feasible, well tolerated, induces brisk tumor responses, and facilitates correlative science. A CD8 T-cell-rich infiltrate indicates a potential immune-mediated mechanism of action. Both proliferation and apoptosis were inhibited, but the mitogen-activated protein kinase pathway remained activated, suggesting intrinsic resistance in a subset of tumor cells. Additional investigation of the anti-tumor immune response during targeted therapy and the mechanisms of intrinsic resistance can yield novel therapeutic strategies.",2015,All 12 patients receiving >14 days of therapy had substantial reduction in tumor volume (65% at day 14 and 78% at day 28) and underwent resection.,"['Thirteen patients with locally or regionally advanced BRAF mutation-positive melanoma received', 'advanced BRAF mutation-positive melanoma']","['dabrafenib 150 mg po bid for 14 days, followed by dabrafenib plus trametinib 2 mg po daily', 'BRAF and mitogen-activated protein kinase kinase (MEK', 'preoperative combined BRAF and MEK-targeted therapy']","['substantial reduction in tumor volume', 'viable melanoma cells and a CD8 T-cell--rich infiltrate']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3644516', 'cui_str': 'trametinib 2 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0169101', 'cui_str': 'MAPKKs'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}]",13.0,0.05353,All 12 patients receiving >14 days of therapy had substantial reduction in tumor volume (65% at day 14 and 78% at day 28) and underwent resection.,"[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Johnson', 'Affiliation': 'Department of Pathology, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Crandall', 'Affiliation': 'Department of Clinical Trials Shared Resource, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dahlman', 'Affiliation': 'Department of Cancer Biology, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Kelley', 'Affiliation': 'Department of Surgery, Division of Surgical Oncology and Endocrine Surgery, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN. Electronic address: mark.kelley@vanderbilt.edu.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2014.12.057']
1047,31153789,Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain.,"BACKGROUND


Recent evidence recommends Pilates for the treatment of chronic low back pain. However, it is still unknown if different weekly frequencies of Pilates can accelerate the improvement of symptoms in patients with chronic low back pain verified by a daily pain assessment.
OBJECTIVE


To analyze whether different weekly frequencies of Pilates can accelerate pain reduction by 30%, 50%, and 100% in patients with non-specific chronic low back pain and the necessary number of weeks to reach these improvements.
METHODS


Two hundred and twenty-two patients were randomized into three groups: Pilates group 1 received treatment once a week, Pilates group 2 received treatment twice a week, and Pilates group 3 received treatment three times a week. All groups received Pilates for six weeks. Pain intensity was measured daily before and after each intervention session using the Pain Numerical Rating Scale. The assessor was not blind.
RESULTS


The survival analysis showed that all Pilates groups had a pain reduction of 30%, 50%, and 100% at the same speed during treatment. There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05). After the first week of treatment, 44.6% of the patients in Pilates group 3 showed complete pain improvement, followed by 37.8% of the patients in Pilates group 2 and 29.7% in Pilates group 1. After the last week, 71.6% (Pilates group 1), 77% (Pilates group 2), and 78.4% (Pilates group 3) of the patients reported complete improvement of symptoms.
CONCLUSION


Different weekly frequencies of Pilates did not accelerate pain improvement in patients with non-specific chronic low back pain. Registered in Clinical Trials Registry: NCT02241538 (https://clinicaltrials.gov/ct2/show/NCT02241538).",2020,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"['Two hundred and twenty-two patients', 'patients with chronic low back pain', 'patients with non-specific chronic low back pain', 'chronic low back pain']",[],"['pain improvement', 'pain reduction', 'Pain intensity', 'complete improvement of symptoms', 'survival analysis', 'Pain Numerical Rating Scale', 'complete pain improvement']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0222045'}]",222.0,0.0593448,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"[{'ForeName': 'Maria Liliane da', 'Initials': 'MLD', 'LastName': 'Silva', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Gisela Cristiane', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil. Electronic address: gfisio_miyamoto@hotmail.com.""}, {'ForeName': 'Katherinne Ferro Moura', 'Initials': 'KFM', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Yuri Rafael Dos Santos', 'Initials': 'YRDS', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Cristina Maria Nunes', 'Initials': 'CMN', 'LastName': 'Cabral', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.001']
1048,31764209,A Randomized Trial of Continuous Versus Intermittent Skin-to-Skin Contact After Premature Birth and the Effects on Mother-Infant Interaction.,"BACKGROUND


Premature birth affects opportunities for interaction between infants and mothers. Skin-to-skin contact (SSC) is standard care in neonatal care but has not been sufficiently studied regarding the effects on interaction between preterm infant and mothers.
PURPOSE


The purpose of this study was to compare interaction between preterm infants and their mothers after continuous versus intermittent SSC from birth to discharge. A secondary aim was to study a potential dose-response effect between time in SSC and quality of interaction.
METHODS


Families were randomly assigned to either continuous (n = 17) or intermittent (n = 14) SSC before delivery. Interaction was measured from videotapes of a Still-Face Paradigm collected at 4 months' corrected age. Face-to-face interaction was coded according to Ainsworth's Maternal Sensitivity Scales and the Maternal Sensitivity and Responsivity Scales-R. Dose-response correlations were calculated between mean time spent in SSC and each of the interaction scales.
RESULTS


There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity. There was no correlation between mean time in SSC and quality of interaction.
IMPLICATIONS FOR PRACTICE


Continuous SSC from birth to discharge was not superior to intermittent SSC concerning mother-infant interaction between preterm infants and their mothers at 4 months' corrected age. However, compared with other studies, mean time in SSC was also high in the intermittent group.
IMPLICATIONS FOR RESEARCH


Further studies are needed to find out how interaction between parents and preterm infants can be improved, supported, and facilitated in the neonatal intensive care unit (NICU) and whether there is an optimal dose for SSC.",2020,"There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity.","['preterm infants and their mothers after continuous versus intermittent SSC from birth to discharge', 'parents and preterm infants', 'infants and mothers', 'Families were randomly assigned to either continuous (n = 17) or intermittent (n = 14', 'Mother-Infant Interaction']","['Skin-to-skin contact (SSC', 'Continuous Versus Intermittent Skin-to-Skin Contact']","['mean time in SSC', 'sensitivity, interference, availability, acceptance, withdrawal, or intrusivity', 'maternal interactive behavior', 'Maternal Sensitivity Scales and the Maternal Sensitivity and Responsivity Scales-R. Dose-response correlations', 'mean time in SSC and quality of interaction']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0369425,"There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sahlén Helmer', 'Affiliation': 'Division of Nursing Science, Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden (Mss Sahlén Helmer and Prof Mörelius); Division of Psychology, Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden (Drs Birberg Thornberg and Frostell); and Division of Neonatology, Department of Woman and Child Health, Karolinska Institutet, Stockholm, Sweden (Dr Örtenstrand).'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Birberg Thornberg', 'Affiliation': ''}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Frostell', 'Affiliation': ''}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Örtenstrand', 'Affiliation': ''}, {'ForeName': 'Evalotte', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000675']
1049,31764258,Insights for Implementation Science From 2 Multiphased Studies With End-Users of Potential Multipurpose Prevention Technology and HIV Prevention Products.,"BACKGROUND


Lower adherence to biomedical HIV prevention and challenges with persistence among young women underscore the need for methods to identify factors that will achieve higher adoption and use of effective prevention options and inform new approaches.
SETTING


South Africa, Kenya, and Zimbabwe.
METHODS


We synthesized findings from 2 multiphased studies (TRIO and Quatro) conducted with young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers. TRIO evaluated 3 products (tablets, ring, and injections), and Quatro compared 4 vaginal products (ring, insert, film, and gel) for HIV prevention. Both were designed to assess product preferences, choice, and use.
RESULTS


Increased experience with placebo products in the crossover study informed young women's product ratings and preferences. Over half changed their mind regarding their most preferred product after trying each one. The integrated qualitative component was vital to understanding what prompted these preference shifts. The discrete choice experiment provided insights on how features not available in placebos, like efficacy and contraception, influence choice and the tradeoffs women may be willing to make to gain a desired product feature.
CONCLUSION


The use of multiple research methods allowed for evaluation of varied dimensions of acceptability, preference, and choice in the context of diverse biomedical HIV prevention delivery forms. Findings elucidated the value of product choice with differences in preference within and across settings. Collectively, the 3 methodologies offered important insights about these products informative to enhanced product design development and future implementation.",2019,"RESULTS


Increased experience with placebo products in the crossover study informed young women's product ratings and preferences.","['young women', 'South Africa, Kenya, and Zimbabwe', 'young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers']",['placebo'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0417957,"RESULTS


Increased experience with placebo products in the crossover study informed young women's product ratings and preferences.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Minnis', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Napierala', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002215']
1050,32410586,Stigma and utilization of treatment for adolescent perinatal depression in Ibadan Nigeria.,"BACKGROUND


Depression is a common and severe disorder among low-income adolescent mothers in low-and middle-income countries where resources for treatment are limited. We wished to identify factors influencing health service utilization for adolescent perinatal depression, in Nigeria to inform new strategies of care delivery.
METHODS


Focus Group Discussions (FGDs) were conducted among purposively selected low-income young mothers (with medical histories of adolescent perinatal depression), and separately with primary care clinicians treating this condition in Ibadan, Nigeria. Participants from this community-based study were from the database of respondents who participated in a previous randomized control trial (RCT) conducted between 2014 and 2016 in 28 primary health care facilities in the 11 Local government areas in Ibadan. Semi-structured interview guides, framed by themes of the Behavioral Model for Vulnerable Populations, was developed to obtain views of participants on the factors that promote or hinder help-seeking and engagement (see additional files 1 & 2). FGDs were conducted, and saturation of themes was achieved after discussions with six groups. Transcripts were analyzed using content analysis.
RESULTS


A total of 42 participants, 17 mothers (who were adolescents at the time of the RCT), and 25 care providers participated in 6 FGDs. The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents. Perceived health benefits of treatment received for perinatal depression were strong motivation for service use. Significant stigma and negative stereotypes expressed by care providers towards adolescent pregnancy and perinatal depression were obstacles to care. However, individual patient resilience was a major enabling factor, facilitating service engagement. Providers trained in the management of perinatal depression were perceived to deliver more tolerant and supportive care that adolescent mothers valued.
CONCLUSIONS


Participants identified unsupportive and stigmatizing clinic environments towards pregnant and parenting adolescents as significant barriers to accessing available care. Interventions to reduce stigma among healthcare providers may improve services for this vulnerable population.",2020,The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents.,"['42 participants, 17 mothers (who were adolescents at the time of the RCT), and 25 care providers participated in 6 FGDs', 'Focus Group Discussions (FGDs) were conducted among purposively selected low-income young mothers (with medical histories of adolescent perinatal depression), and separately with primary care clinicians treating this condition in Ibadan, Nigeria', 'adolescent perinatal depression in Ibadan Nigeria', 'Participants from this community-based study were from the database of respondents who participated in a previous randomized control trial (RCT) conducted between 2014 and 2016 in 28 primary health care facilities in the 11 Local government areas in Ibadan']",[],[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026788', 'cui_str': 'Government, Local'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],42.0,0.0691441,The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents.,"[{'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. lola_kola2004@yahoo.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Bennett', 'Affiliation': 'Departments of Family Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Bhat', 'Affiliation': 'Departments of Family Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Olatunde O', 'Initials': 'OO', 'LastName': 'Ayinde', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Bibilola D', 'Initials': 'BD', 'LastName': 'Oladeji', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Dolapo', 'Initials': 'D', 'LastName': 'Abiona', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Jibril', 'Initials': 'J', 'LastName': 'Abdumalik', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Faregh', 'Affiliation': 'Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Pamela Y', 'Initials': 'PY', 'LastName': 'Collins', 'Affiliation': 'Psychiatry and Behavioral Science, University of Washington, Seattle, USA.'}, {'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02970-4']
1051,30954567,Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial.,"BACKGROUND


Cytotoxic chemotherapy is generally ineffective in patients with hepatocellular carcinoma. We assessed the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed.
METHODS


We did a multicentre, open-label, randomised, controlled phase 3 trial at 70 sites in 11 countries. Patients with hepatocellular carcinoma with one or more previous systemic therapies, including sorafenib, were randomly assigned to receive 30 mg/m 2  doxorubicin-loaded nanoparticles (30 mg/m 2  group), 20 mg/m 2  doxorubicin-loaded nanoparticles (20 mg/m 2  group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region. Patients in the experimental groups received perfusion of the drug every 4 weeks and those in the control group received any systemic anticancer therapy (except sorafenib) as per investigator decision. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, number NCT01655693.
FINDINGS


Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397 were randomly assigned to one of the groups (133 to the 30 mg/m 2  group; 130 to the 20 mg/m 2  group; and 134 to the control group). Median follow-up was 22·7 months (IQR 11·2-34·9). After pooling the doxorubicin groups for the efficacy analysis, median overall survival was 9·1 months (95% CI 8·1-10·4) in the pooled doxorubicin-loaded nanoparticles group and 9·0 months (7·1-11·8) in the control group (HR 1·00 [95% CI 0·78-1·28], two-sided p=0·99). 227 (94%) of 242 patients who received doxorubicin-loaded nanoparticles and 100 (75%) of 134 patients in the control group had at least one treatment-emergent adverse event. The most common drug-related grade 3 or 4 treatment-emergent adverse events were neutropenia (25 [10%] of 242 treated with doxorubicin-loaded nanoparticles and eight [6%] of 134 in the control group), asthenia (six [2%] and four [3%]), and thrombocytopenia (three [1%] and ten [7%]). Six (2%) patients treated with doxorubicin-loaded nanoparticles and one (1%) of those in the control group were deemed by investigators to have had a drug-related death. Serious adverse events occurred in 74 (31%) patients who received doxorubicin-loaded nanoparticles and 48 (36%) in the control group.
INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
FUNDING


Onxeo.",2019,"INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
","['70 sites in 11 countries', 'Patients with hepatocellular carcinoma with one or more previous systemic therapies, including', 'patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed', 'patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed', 'patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE', 'Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397', 'patients with hepatocellular carcinoma']","['Doxorubicin-loaded nanoparticles', 'doxorubicin-loaded nanoparticles', 'doxorubicin-loaded nanoparticles (30 mg/m 2  group), 20 mg/m 2  doxorubicin-loaded nanoparticles (20 mg/m 2  group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region', 'doxorubicin', 'systemic anticancer therapy (except sorafenib', 'Cytotoxic chemotherapy', 'sorafenib']","['thrombocytopenia', 'neutropenia', 'asthenia', 'efficacy analysis, median overall survival', 'overall survival', 'Safety', 'Serious adverse events']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",541.0,0.142065,"INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""Service d'Hépatologie et Gastroentérologie, Hôpital de la Croix-Rousse, Lyon, France. Electronic address: philippe.merle@chu-lyon.fr.""}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hôpital Haut Lévèque, Pessac, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) de Saint-Étienne, Saint-Étienne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pelletier', 'Affiliation': 'Hôpital Paul Brousse, Villejuif, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': 'CHU de Nancy-Hôpital Brabois, Nancy, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Touchefeu', 'Affiliation': 'CHU Nantes-Hôpital Hôtel Dieu, Nantes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Pageaux', 'Affiliation': 'CHU de Montpellier-Hôpital Saint-Eloi, Montpellier, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Gerolami', 'Affiliation': 'Hôpital de la Conception, Marseille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Habersetzer', 'Affiliation': 'Centre Hospitalier Regional Universitaire de Strasbourg-Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nguyen-Khac', 'Affiliation': ""CHU d'Amiens, Hôpital Nord, Amiens, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei-Gardini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'Université Catholique de Louvain Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'CHU de Nice-Hôpital Archet, Nice, France.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Wege', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amr Shafik', 'Initials': 'AS', 'LastName': 'Saad', 'Affiliation': 'Department of Oncology, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': ""Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Abergel', 'Affiliation': 'CHU de Clermont-Ferrand-Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Richou', 'Affiliation': 'CHU Jean Minjoz, Besançon, France.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Waked', 'Affiliation': 'National Liver Institute, Menoufyia University, Menoufyia, Egypt.'}, {'ForeName': 'Nelson S', 'Initials': 'NS', 'LastName': 'Yee', 'Affiliation': 'Penn State Cancer Institute Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Molé', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Attali', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Le Boulicaut', 'Affiliation': 'eXYSTAT, Malakoff, France.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Vasseur', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30040-8']
1052,31512330,Creatine supplementation improves performance above critical power but does not influence the magnitude of neuromuscular fatigue at task failure.,"NEW FINDINGS


What is the central question of this study? Does the magnitude of neuromuscular fatigue depend on the amount of work done (W') at task failure when cycling above critical power (CP)? What is the main finding and its importance? Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo. Increased W' does not lead to higher levels of neuromuscular fatigue. This supports the notion of a critical level of neuromuscular fatigue at task failure and challenges a direct causative link between W' depletion and neuromuscular fatigue.
ABSTRACT


The present study examined the effect of creatine supplementation on neuromuscular fatigue and exercise tolerance when cycling above critical power (CP). Eleven males performed an incremental cycling test with four to five constant-load trials to task failure (TTF) to obtain asymptote (CP) and curvature constant (W') of the power-duration relationship, followed by three constant-load supra-CP trials: (1) one TTF following placebo supplementation (PLA); (2) one TTF following creatine supplementation (CRE); and (3) one trial of equal duration to PLA following creatine supplementation (ISO). Neuromuscular assessment of the right knee extensors was performed pre- and post-exercise to measure maximal voluntary contraction (MVC), twitch forces evoked by single (Q pot  ) and paired high- (PS100) and low- (PS10) frequency stimulations and voluntary activation. Creatine supplementation increased TTF in CRE vs. PLA by ∼11% (P = 0.017) and work done above CP by ∼10% (P = 0.015), with no difference (P > 0.05) in reductions in MVC (-24 ± 8% vs. -20 ± 9%), Q pot  (-39 ± 13% vs. -32 ± 14%), PS10 (-42 ± 14% vs. -36 ± 13%), PS100 (-25 ± 10% vs. -18 ± 12%) and voluntary activation (-7 ± 8% vs. -5 ± 7%). No significant difference was found between ISO and either PLA or CRE (P > 0.05). These findings suggest similar levels of neuromuscular fatigue can be found following supra-CP cycling despite increases in performance time and amount of work done above CP, supporting the notion of a critical level of neuromuscular fatigue and challenging a direct causative link between W' depletion and neuromuscular fatigue.",2019,"Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo.",['Eleven males'],"['PLA following creatine supplementation (ISO', 'creatine supplementation', 'PS100', ""incremental cycling test with four to five constant-load trials to task failure (TTF) to obtain asymptote (CP) and curvature constant (W') of the power-duration relationship, followed by three constant-load supra-CP trials: (1) one TTF following placebo supplementation (PLA); (2) one TTF following creatine supplementation (CRE"", 'placebo', 'Creatine supplementation']","['TTF', ""W' and enhances supra-CP performance"", 'maximal voluntary contraction (MVC), twitch forces evoked by single (Q pot  ) and paired high- (PS100) and low- (PS10) frequency stimulations and voluntary activation', 'neuromuscular fatigue', 'ISO and either PLA or CRE', 'voluntary activation', 'neuromuscular fatigue and exercise tolerance']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue, function (observable entity)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",,0.0659042,"Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo.","[{'ForeName': 'Lisa U', 'Initials': 'LU', 'LastName': 'Schäfer', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Dekerle', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}]",Experimental physiology,['10.1113/EP087886']
1053,32410578,Application of the matched nested case-control design to the secondary analysis of trial data.,"BACKGROUND


A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
METHODS


We demonstrate the utility of the matched nested case-control design by applying it to a secondary analysis of the Abnormal Doppler Enteral Prescription Trial. We investigated the role of milk feed type and changes in milk feed type in the development of necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants.
RESULTS


Using matching, we were able to generate a comparable sample of controls selected from the same population as the cases. In contrast to the standard case-control design, exposure status was ascertained prior to the outcome event occurring and the comparison between the cases and matched controls could be made at the point at which the event occurred. This enabled us to reliably investigate the temporal relationship between feed type and necrotising enterocolitis.
CONCLUSIONS


A matched nested case-control study can be used to identify credible associations in a secondary analysis of clinical trial data where the exposure of interest was not randomised, and has several advantages over a standard case-control design. This method offers the potential to make reliable inferences in scenarios where it would be unethical or impractical to perform a randomised clinical trial.",2020,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
",['necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants'],[],[],"[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],[],,0.039978,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. chris.partlett@nottingham.ac.uk.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Hall', 'Affiliation': 'University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01007-w']
1054,32410596,Interpretation of within-group change in randomised trials.,"In medicine, it is common to observe improvement after intervention, at least partly because patients present for care in extremis and would have improved without intervention. Controlling for this counterfactual explanation for improvement is the principle reason to conduct a trial in which patients are randomised to treatment or a control group. Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",2020,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",[],[],[],[],[],[],,0.069099,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.","[{'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Kypri', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia. kypros.kypri@newcastle.edu.au.'}]",BMC psychiatry,['10.1186/s12888-020-02641-w']
1055,31173304,Structural exercise-based intervention for health problems in individuals with autism spectrum disorders: a pilot study.,"OBJECTIVE


Exercise-based intervention promises to be more effective in a structured framework for individuals with autism spectrum disorders (ASD). The aim of this study was to observe changes in behavior of individuals with ASD by investigating their physical status after the structured exercise-based intervention.
PATIENTS AND METHODS


The exercise intervention integrated an 8-week exercise program that included aerobic, resistive, and neuromuscular exercises. Body composition and the Autism Treatment Evaluation Checklist (ATEC) were evaluated to assess changes after the exercise-based intervention.
RESULTS


After the exercise intervention, the fat mass of individuals with ASD were significantly reduced, and their behavior improved markedly.
CONCLUSIONS


This pilot study demonstrated that individuals with ASD require long-term, structured exercise-based intervention, and that such exercise-based intervention is effective for improving their health.",2019,"Body composition and the Autism Treatment Evaluation Checklist (ATEC) were evaluated to assess changes after the exercise-based intervention.
","['individuals with autism spectrum disorders', 'individuals with ASD require long-term', 'individuals with autism spectrum disorders (ASD', 'individuals with ASD']","['structured exercise-based intervention, and that such exercise-based intervention', 'Exercise-based intervention promises', 'Structural exercise-based intervention', 'exercise intervention integrated an 8-week exercise program that included aerobic, resistive, and neuromuscular exercises']","['Body composition and the Autism Treatment Evaluation Checklist (ATEC', 'fat mass of individuals with ASD', 'behavior improved markedly']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}]",,0.0233776,"Body composition and the Autism Treatment Evaluation Checklist (ATEC) were evaluated to assess changes after the exercise-based intervention.
","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Sport and Health Science, Nanjing Sport Institute, Nanjing, China. yeqiang@nsi.edu.cn.'}, {'ForeName': 'G-Y', 'Initials': 'GY', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Y-B', 'Initials': 'YB', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'G-W', 'Initials': 'GW', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201905_17937']
1056,31169912,Association of 3-Year Multidomain Intervention and Omega-3 Supplementation with Frailty Incidence.,"OBJECTIVES


To assess the associations of long-term lifestyle multidomain intervention (MI) and omega-3 supplementation with frailty level evolution and frailty incidence in community-dwelling older persons.
DESIGN


Secondary analysis of the randomized controlled Multidomain Alzheimer Preventive Trial.
SETTING


Thirteen memory centers in France and Monaco between 2008 and 2011.
PARTICIPANTS


A total of 1588 community-dwelling persons aged 70 years or older with memory complaints (without dementia), slow gait speed, or limitation in one instrumental activity of daily living.
INTERVENTION


A 3-year MI (43 group sessions including cognitive training, physical activity, and nutrition advice and three preventive consultations) plus daily omega-3 fatty acids, MI plus placebo, omega-3 alone, or placebo alone.
MEASUREMENTS


The frailty phenotype (unintentional weight loss, exhaustion, low physical activity, slow gait, low handgrip strength: 0 to 5 score, higher is worse; a score of 3 or higher defines frailty) was assessed at baseline, 6, 12, 24, and 36 months. We used mixed-effect models for frailty level (0-5 score as an ordinal variable) and Cox models for frailty incidence.
RESULTS


No differences were found between the intervention groups and placebo on the 3-year evolution of frailty level. Among 1394 non-frail participants at baseline, frailty incidence occurred in 134 (9.6%) persons: 26 (7.6%) in the MI plus omega-3 group, 34 (10%) in the omega-3 alone group, 31 (8.5%) in the MI plus placebo group, and 43 (12.3%) in the placebo-alone group). No differences regarding frailty incidence were found between intervention groups and placebo. After exclusion of 53 participants with incident frailty during the first year of follow-up, MI plus omega-3 was associated with a lower frailty incidence compared with placebo (hazard ratio = .43; 95% confidence interval = .22-.81).
CONCLUSION


In community-dwelling older persons, the combination of a long-term lifestyle MI and omega-3 supplementation did not reduce frailty level or incidence. The reduction of frailty incidence associated with the combined intervention in a sensitivity analysis needs to be further confirmed. J Am Geriatr Soc 67:1700-1706, 2019.",2019,No differences were found between the intervention groups and placebo on the 3-year evolution of frailty level.,"['1394 non-frail participants', 'A total of 1588 community-dwelling persons aged 70 years or older with memory complaints (without dementia), slow gait speed, or limitation in one instrumental activity of daily living', 'Thirteen memory centers in France and Monaco between 2008 and 2011', 'community-dwelling older persons']","['long-term lifestyle multidomain intervention (MI) and omega-3 supplementation', 'Multidomain Intervention and Omega-3 Supplementation', 'placebo', 'cognitive training, physical activity, and nutrition advice and three preventive consultations) plus daily omega-3 fatty acids, MI plus placebo, omega-3 alone, or placebo alone']","['3-year evolution of frailty level', 'frailty phenotype (unintentional weight loss, exhaustion, low physical activity', 'slow gait, low handgrip strength', 'frailty incidence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0026405', 'cui_str': 'Monaco'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C2363736', 'cui_str': 'Involuntary weight loss'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",53.0,0.17383,No differences were found between the intervention groups and placebo on the 3-year evolution of frailty level.,"[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Guerville', 'Affiliation': 'Gérontopôle of Toulouse, Institute of Aging, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle of Toulouse, Institute of Aging, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Kelly Virecoulon', 'Initials': 'KV', 'LastName': 'Giudici', 'Affiliation': 'Gérontopôle of Toulouse, Institute of Aging, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle of Toulouse, Institute of Aging, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle of Toulouse, Institute of Aging, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Geriatrics Society,['10.1111/jgs.15994']
1057,32410636,Augmented reality-based navigation increases precision of pedicle screw insertion.,"BACKGROUND


Precise insertion of pedicle screws is important to avoid injury to closely adjacent neurovascular structures. The standard method for the insertion of pedicle screws is based on anatomical landmarks (free-hand technique). Head-mounted augmented reality (AR) devices can be used to guide instrumentation and implant placement in spinal surgery. This study evaluates the feasibility and precision of AR technology to improve precision of pedicle screw insertion compared to the current standard technique.
METHODS


Two board-certified orthopedic surgeons specialized in spine surgery and two novice surgeons were each instructed to drill pilot holes for 40 pedicle screws in eighty lumbar vertebra sawbones models in an agar-based gel. One hundred and sixty pedicles were randomized into two groups: the standard free-hand technique (FH) and augmented reality technique (AR). A 3D model of the vertebral body was superimposed over the AR headset. Half of the pedicles were drilled using the FH method, and the other half using the AR method.
RESULTS


The average minimal distance of the drill axis to the pedicle wall (MAPW) was similar in both groups for expert surgeons (FH 4.8 ± 1.0 mm vs. AR 5.0 ± 1.4 mm, p = 0.389) but for novice surgeons (FH 3.4 mm ± 1.8 mm, AR 4.2 ± 1.8 mm, p = 0.044). Expert surgeons showed 0 primary drill pedicle perforations (PDPP) in both the FH and AR groups. Novices showed 3 (7.5%) PDPP in the FH group and one perforation (2.5%) in the AR group, respectively (p > 0.005). Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set 6-, 7-, and 8-mm screws (p > 0.05). Novices showed significant differences of SSPP between most groups: 6-mm screws, 18 (45%) vs. 7 (17.5%), p = 0.006; 7-mm screws, 20 (50%) vs. 10 (25%), p = 0.013; and 8-mm screws, 22 (55%) vs. 15 (37.5%), p = 0.053, in the FH and AR group, respectively. In novices, the average optimal medio-lateral convergent angle (oMLCA) was 3.23° (STD 4.90) and 0.62° (STD 4.56) for the FH and AR set screws (p = 0.017), respectively. Novices drilled with a higher precision with respect to the cranio-caudal inclination angle (CCIA) category (p = 0.04) with AR.
CONCLUSION


In this study, the additional anatomical information provided by the AR headset superimposed to real-world anatomy improved the precision of drilling pilot holes for pedicle screws in a laboratory setting and decreases the effect of surgeon's experience. Further technical development and validations studies are currently being performed to investigate potential clinical benefits of the herein described AR-based navigation approach.",2020,Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set,"['Two board-certified orthopedic surgeons specialized in spine surgery and two novice surgeons', 'One hundred and sixty pedicles']","['Head-mounted augmented reality (AR) devices', 'standard free-hand technique (FH) and augmented reality technique (AR']","['SSPP', 'average minimal distance of the drill axis to the pedicle wall (MAPW', 'average secondary screw pedicle perforations (SSPP', 'average optimal medio-lateral convergent angle (oMLCA', 'primary drill pedicle perforations (PDPP']","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456980', 'cui_str': 'Hand endodontic technique'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",160.0,0.0294771,Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set,"[{'ForeName': 'Cyrill', 'Initials': 'C', 'LastName': 'Dennler', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland. cyrill.dennler@gmail.com.'}, {'ForeName': 'Laurenz', 'Initials': 'L', 'LastName': 'Jaberg', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Spirig', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Agten', 'Affiliation': 'Department of Radiology, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': 'Laboratory for Biomechanics, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Fürnstahl', 'Affiliation': 'Computer Assisted Research and Development Group, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Farshad', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01690-x']
1058,32410641,Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial.,"BACKGROUND


Previous studies suggested that acupuncture was a promising adjunctive treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The aim of the present trial is to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in patients with asthma.
METHODS/DESIGN


This is a randomized controlled functional brain imaging trial currently being conducted in Sichuan, China. In total, 48 patients with mild to moderate persistent asthma will be recruited randomly and allocated to either of two acupuncture groups: acupuncture at the lung meridian or acupuncture at the heart meridian. The treatment period will last 4 weeks. The Asthma Quality of Life Questionnaire is the primary outcome. The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed between groups, then, the Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group.
DISCUSSION


The present study has been established on the basis of the ""meridian-viscera relationship"" theory of traditional Chinese medicine and the modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand knowledge of acupuncture for asthma.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.",2020,"The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions.","['patients with asthma', 'patients with persistent asthma', '48 patients with mild to moderate persistent asthma']","['acupuncture', 'Functional magnetic resonance imaging (fMRI', 'acupuncture at the lung meridian or acupuncture']","['Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1\u2009s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale', 'Asthma Quality of Life Questionnaire', 'cerebral activity', 'cerebral activity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]","[{'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",48.0,0.161571,"The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Zhaoxuan', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Fifth People's Hospital of Chengdu, Chengdu, 611130, Sichuan, China.""}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China. lanleicdutcm281@foxmail.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China. zeng_fang@cdutcm.edu.cn.'}]",Trials,['10.1186/s13063-020-04319-w']
1059,31754645,Delta oscillations phase limit neural activity during sevoflurane anesthesia.,"Understanding anesthetic mechanisms with the goal of producing anesthetic states with limited systemic side effects is a major objective of neuroscience research in anesthesiology. Coherent frontal alpha oscillations have been postulated as a mechanism of sevoflurane general anesthesia. This postulate remains unproven. Therefore, we performed a single-site, randomized, cross-over, high-density electroencephalogram study of sevoflurane and sevoflurane- plus -ketamine general anesthesia in 12 healthy subjects. Data were analyzed with multitaper spectral, global coherence, cross-frequency coupling, and phase-dependent methods. Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia. Taken together, our results suggest that subanesthetic and general anesthetic sevoflurane brain states emerge from impaired information processing instantiated by a delta-higher frequency phase-amplitude coupling syntax. These results provide fundamental new insights into the neural circuit mechanisms of sevoflurane anesthesia and suggest that anesthetic states may be produced by extracranial perturbations that cause delta-higher frequency phase-amplitude interactions.",2019,Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia.,['12 healthy subjects'],"['sevoflurane and sevoflurane- plus -ketamine general anesthesia', 'sevoflurane anesthesia']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",[],12.0,0.137912,Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia.,"[{'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Chamadia', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Pedemonte', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Eunice Y', 'Initials': 'EY', 'LastName': 'Hahm', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mekonnen', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Reine', 'Initials': 'R', 'LastName': 'Ibala', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Gitlin', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Breanna R', 'Initials': 'BR', 'LastName': 'Ethridge', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vazquez', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Erika T', 'Initials': 'ET', 'LastName': 'Liao', 'Affiliation': '3Tulane University of Medicine, New Orleans, LA 70112 USA.'}, {'ForeName': 'Emery N', 'Initials': 'EN', 'LastName': 'Brown', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}]",Communications biology,['10.1038/s42003-019-0664-3']
1060,31162549,The Effects of Dapagliflozin on Systemic and Renal Vascular Function Display an Epigenetic Signature.,"CONTEXT


Mechanisms mediating the cardiovascular and renal protection exerted by SGLT2 inhibitors are still partially unknown. We investigated whether dapagliflozin modulates systemic and renal vascular function and structure, and induces epigenetic modifications.
SUBJECTS AND METHODS


Forty hypertensive patients with type 2 diabetes were randomly assigned to 4-week treatment with dapagliflozin 10 mg or hydrochlorothiazide (HCT) 12.5 mg. Routine analyses; plasma renin activity; aldosterone, catecholamine, and 24-hour urinary electrolyte levels; flow-mediated dilation (FMD) of the brachial artery; carotid-femoral pulse-wave velocity (PWV); augmentation index; and resistive index and dynamic renal resistive index (DRIN) were measured at baseline and after treatment. Circulating miRNAs (miRs) related to heart failure (miR30e-5p, miR199a-3p), endothelial dysfunction (miR27b and miR200b), and renal function (miR130b-3p, miR21-5p) were assessed and related to the effects of treatments.
RESULTS


Dapagliflozin and HCT marginally lowered blood pressure. Fasting glucose was lowered, whereas 24-hour diuresis, glycosuria, and osmolar clearance were increased by dapagliflozin (P < 0.001 for all), without affecting sodium excretion and glomerular filtration rate. Magnesium levels significantly increased after dapagliflozin treatment (P = 0.02). Neither dapagliflozin nor HCT modified FMD or PWV. DRIN did not vary in the dapagliflozin group, whereas it increased in the HCT group (P = 0.047 for time by treatment interaction). Both treatments induced variations in the expression of some miRs; dapagliflozin, but not HCT, significantly up-regulated miR30e-5p and downregulated miR199a-3p.
CONCLUSION


A putative epigenetic regulation of the protecting cardiovascular effect exerted by SGLT2 inhibitors was found. Dapagliflozin might exert nephroprotection by preserving renal vasodilating capacity.",2019,"Both treatments induced variations in the expression of some miRNA; dapagliflozin, but not hydrochlorothiazide, significantly up-regulated miR30e-5p and down-regulated miR199a-3p.
",['Forty hypertensive patients with type 2 diabetes'],"['Magnesium', 'dapagliflozin 10mg or hydrochlorothiazide', 'hydrochlorothiazide', 'dapagliflozin and hydrochlorothiazide', 'dapagliflozin']","['blood pressure', '24h diuresis, glycosuria and osmolar clearance', 'sodium excretion and glomerular filtration rate', 'plasma renin activity, aldosterone, catecholamines, 24 hour-urinary electrolytes, flow-mediated dilation of the brachial artery (FMD), carotid-femoral pulse-wave velocity (PWV), Augmentation Index (AIx) and baseline (RI) and dynamic renal resistive index (DRIN', 'heart failure (miR30e-5p, miR199a-3p), endothelial dysfunction (miR27b and miR200b) and renal function', 'DRIN', 'Fasting glucose']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0439351', 'cui_str': 'osmolar'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",40.0,0.0250506,"Both treatments induced variations in the expression of some miRNA; dapagliflozin, but not hydrochlorothiazide, significantly up-regulated miR30e-5p and down-regulated miR199a-3p.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seghieri', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Giannini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dardano', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ghiadoni', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00706']
1061,30990099,Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg.,"The objective of the study was to evaluate the sexual function and quality of life (QoL) of healthy women on a new contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47 mg and etonogestrel (ENG) 11.00 mg (study group) manufactured with a new polymer composition compared to EE 2.7 mg/ENG11.7 mg CVR (control group). Fifty-eight women were randomly allocated to the study group and the control group. The Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS) and the Short Form-36, were used to assess sexual function, sexual distress and QoL, respectively. The study included two follow-ups, at 90 days and at 180 days. The control group reported more adverse events, mainly breakthrough bleeding, than the study group. The sexual function scores in the women in the study group improved with respect to those of the control group both at the 1st (FSFI,  p  = .009; FSDS,  p  = .001) and at the 2 nd  (FSFI,  p  = .001; FSDS,  p  = .002) follow-up. QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up. The control group improved their QoL at the 2nd follow-up ( p  < .01). The more gradual EE release of the new polymer composition could justify the behavioral differences of the women of the two groups.",2019,QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up.,"['healthy women on a new', 'Fifty-eight women']","['contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47\u2009mg and etonogestrel (ENG', 'EE 2.7\u2009mg/ENG11.7\u2009mg CVR', 'contraceptive vaginal ring containing ethinylestradiol/etonogestrel']","['sexual function and quality of life (QoL', 'adverse events, mainly breakthrough bleeding', 'QoL', 'sexual function scores', 'sexual function and quality of life', 'Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}]",58.0,0.0198055,QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up.,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Panella', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Giunta', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Matarazzo', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cianci', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1603290']
1062,31129129,"IL-17A inhibition by secukinumab induces early clinical, histopathologic, and molecular resolution of psoriasis.","BACKGROUND


Hyperactivity of the IL-23/IL-17 axis is central to plaque psoriasis pathogenesis. Secukinumab, a fully human mAb that selectively inhibits IL-17A, is approved for treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. Secukinumab improves the complete spectrum of psoriasis manifestations, with durable clinical responses beyond 5 years of treatment. In the feed-forward model of plaque chronicity, IL-17A has been hypothesized as the key driver of pathogenic gene expression by lesional keratinocytes, but in vivo evidence in human subjects is lacking.
METHODS


We performed a randomized, double-blind, placebo-controlled study (NCT01537432) of patients receiving secukinumab at the clinically approved dose up to 12 weeks. We then correlated plaque and nonlesional skin transcriptomic profiles with histopathologic and clinical measures of efficacy.
RESULTS


After 12 weeks of treatment, secukinumab reversed plaque histopathology in the majority of patients and modulated thousands of transcripts. Suppression of the IL-23/IL-17 axis by secukinumab was evident at week 1 and continued through week 12, including reductions in levels of the upstream cytokine IL-23, the drug target IL-17A, and downstream targets, including β-defensin 2. Suppression of the IL-23/IL-17 axis by secukinumab at week 4 was associated with clinical and histologic responses at week 12. Secukinumab did not affect ex vivo T-cell activation, which is consistent with its favorable long-term safety profile.
CONCLUSION


Our data suggest that IL-17A is the critical node within the multidimensional pathogenic immune circuits that maintain psoriasis plaques and that early reduction of IL-17A-dependent feed-forward transcripts synthesized by hyperplastic keratinocytes favors plaque resolution.",2019,"Suppression of the IL-23/IL-17-axis by secukinumab was evident at Week 1 and continued through Week 12, including reductions in the upstream cytokine IL-23, drug target IL-17A, and downstream targets including beta-defensin2.",['patients receiving secukinumab at the clinically approved dose up to 12 weeks'],"['IL-17A', 'secukinumab', 'placebo', 'Secukinumab']","['plaque histopathology', 'ex vivo T-cell activation', 'complete spectrum of psoriasis manifestations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]",,0.148222,"Suppression of the IL-23/IL-17-axis by secukinumab was evident at Week 1 and continued through Week 12, including reductions in the upstream cytokine IL-23, drug target IL-17A, and downstream targets including beta-defensin2.","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory of Investigative Dermatology, Rockefeller University, New York, NY. Electronic address: jgk@rockefeller.edu.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Wharton', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Mass.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schlitt', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Suprun', 'Affiliation': 'Department of Population Health Science and Policy, Department of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebecca I', 'Initials': 'RI', 'LastName': 'Torene', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Mass.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Mass.'}, {'ForeName': 'Claire Q', 'Initials': 'CQ', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Judilyn', 'Initials': 'J', 'LastName': 'Fuentes-Duculan', 'Affiliation': 'Laboratory of Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hartmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Koroleva', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Mass.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hillenbrand', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Letzkus', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Novartis Institutes for Biomedical Research, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Novartis Pharmaceuticals AG, Basel, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Glueck', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hasselberg', 'Affiliation': 'Novartis Pharmaceuticals AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flannery', 'Affiliation': 'Novartis Institutes for Biomedical Research, East Hanover, NJ.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suárez-Fariñas', 'Affiliation': 'Laboratory of Investigative Dermatology, Rockefeller University, New York, NY; Department of Population Health Science and Policy, Department of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hueber', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.04.029']
1063,31154809,Levetiracetam for prophylactic treatment of pediatric migraine: A randomized double-blind placebo-controlled trial.,"INTRODUCTION


Few drugs are available for migraine prophylaxis in children. Levetiracetam is a broad-spectrum anti-seizure drug that has been suggested to be effective in reducing adult migraine episodes. We assessed the safety and efficacy of levetiracetam in the prevention of pediatric migraine.
METHODS


A randomized double-blind placebo-controlled trial was performed. Eligible participants were aged 4-17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes. Primary endpoints were the mean changes in monthly frequency and intensity of headaches from the baseline phase to the last month of the double-blind phase. Safety endpoint was the adverse effects reported.
RESULTS


Sixty-one participants (31 taking levetiracetam and 30 taking placebo) completed the study. All had a significant reduction in frequency and intensity of episodes that was significantly greater in the levetiracetam arm. Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p -value: 0.007). Irritability, day-time sedation, and mild tic were reported.
CONCLUSION


Levetiracetam may be useful in migraine prevention and may decrease migraine episodes and severity.
TRIAL REGISTRATION


The study is prospectively registered with Iranian Registry of Clinical Trials; IRCT.ir, number IRCT2017021632603N1.",2019,Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p-value: 0.007).,"['pediatric migraine', 'Eligible participants were aged 4-17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes', 'Sixty-one participants (31 taking levetiracetam and 30 taking', 'children']","['levetiracetam', 'Levetiracetam', 'placebo']","['Irritability, day-time sedation, and mild tic', 'safety and efficacy', 'reduction of episodes', 'frequency and intensity of episodes', 'mean changes in monthly frequency and intensity of headaches']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",,0.689101,Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p-value: 0.007).,"[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Montazerlotfelahi', 'Affiliation': 'Pediatrics Center of Excellence, Department of Pediatric Neurology, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Amanat', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Tavasoli', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Zamani', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Josemir W', 'Initials': 'JW', 'LastName': 'Sander', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands.'}, {'ForeName': 'Reza Shervin', 'Initials': 'RS', 'LastName': 'Badv', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric Neurology, Golestan University of Medical Sciences, Golestan, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Ashrafi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419851814']
1064,31754836,Use of low-level laser therapy (LLLT) or photobiomodulation (PBM) for the management of the hand-foot syndrome (HSF) or palmo-plantar erythrodysesthesia (PPED) associated with cancer therapy.,"The purpose of this pilot study was to determine whether photobiomodulation (PBM) might be effective for chemotherapy-induced palmo-plantar erythrodyesthesia (PPED), as it is for mucositis or radio dermatitis; no standard therapy exists for PPED. Patients were allocated to PBM or sham irradiation and were blindly assessed after 2 weeks. Pain and satisfaction with treatment were also evaluated. We found a significant benefit from PBM in comparison with sham treatment (p < 0.03) and a decrease of pain in 49% of the patients. No adverse reactions were observed. We concluded that PBM might represent a useful approach for the management of PPED.",2020,We found a significant benefit from PBM in comparison with sham treatment (p < 0.03) and a decrease of pain in 49% of the patients.,[],"['low-level laser therapy (LLLT) or photobiomodulation (PBM', 'photobiomodulation (PBM', 'PBM or sham irradiation', 'PBM']","['pain', 'Pain and satisfaction', 'adverse reactions']",[],"[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0302752,We found a significant benefit from PBM in comparison with sham treatment (p < 0.03) and a decrease of pain in 49% of the patients.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Latifyan', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles Centre des Tumeurs de l'ULB, Rue Héger-Bordet, 1, 1000, Brussels, Belgium.""}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Genot', 'Affiliation': ""Laser Therapy Unit, Institut Jules Bordet, Université Libre de Bruxelles Centre des Tumeurs de l'ULB, Rue Héger-Bordet, 1, 1000, Brussels, Belgium.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fernez', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles Centre des Tumeurs de l'ULB, Rue Héger-Bordet, 1, 1000, Brussels, Belgium.""}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Scharll', 'Affiliation': ""Laser Therapy Unit, Institut Jules Bordet, Université Libre de Bruxelles Centre des Tumeurs de l'ULB, Rue Héger-Bordet, 1, 1000, Brussels, Belgium.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Klastersky', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles Centre des Tumeurs de l'ULB, Rue Héger-Bordet, 1, 1000, Brussels, Belgium. jean.klastersky@bordet.be.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05099-z']
1065,31145938,Endolysin treatment against Staphylococcus aureus in adults with atopic dermatitis: A randomized controlled trial.,,2019,,['adults with atopic dermatitis'],['Endolysin'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C0059246', 'cui_str': 'lambda-endolysin'}]",[],,0.281841,,"[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'de Wit', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joan E E', 'Initials': 'JEE', 'LastName': 'Totté', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Minke M F', 'Initials': 'MMF', 'LastName': 'van Mierlo', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'van Veldhuizen', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank H J', 'Initials': 'FHJ', 'LastName': 'Schuren', 'Affiliation': 'TNO, Microbiology and Systems Biology Group, Zeist, The Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Luba M', 'Initials': 'LM', 'LastName': 'Pardo', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Suzanne G M A', 'Initials': 'SGMA', 'LastName': 'Pasmans', 'Affiliation': 'Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. Electronic address: s.pasmans@erasmusmc.nl.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.05.020']
1066,31758326,Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial.,"PURPOSE


Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis.
METHODS


This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion.
RESULTS


Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT.
CONCLUSIONS


Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.",2020,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"['radiation dermatitis and pain', '191 breast cancer patients', '191 randomized patients', '171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88', 'patients with high breast separation (≥ 25 cm) who may have the worst skin reactions']","['placebo', 'topical agents', 'topical agents (Curcumin, HPR Plus™, and Placebo']","['pain scores', 'RDS scores', 'radiation dermatitis severity', 'prophylactic effectiveness', 'Mean radiation dermatitis severity (RDS) scores', 'skin reactions and pain', 'radiation dermatitis and associated pain']","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0423754', 'cui_str': 'Poor skin condition (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",191.0,0.2804,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ryan Wolf', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. julie_ryan@urmc.rochester.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Strasser', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, DE, USA.'}, {'ForeName': 'Pawal', 'Initials': 'P', 'LastName': 'Dyk', 'Affiliation': 'Heartland Cancer Research NCORP, St. Louis, MO, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Columbus NCORP, Columbus, OH, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gross', 'Affiliation': 'Dayton Clinical Oncology Program, Dayton, OH, USA.'}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Speer', 'Affiliation': 'Metro-Minnesota NCORP, St. Louis Park, MN, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Dolohanty', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bylund', 'Affiliation': 'Department Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Pentland', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05166-5']
1067,31748467,Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial.,"AIM


In patients with hyperlipidemia, intolerance to statins presents a challenge in reducing the risk of events associated with cardiovascular disease. This phase 3, randomized, double-blind trial in Japanese patients with statin intolerance aimed to evaluate the efficacy and safety of evolocumab vs. ezetimibe in lowering low-density lipoprotein-cholesterol (LDL-C).
METHODS


This study was conducted in a 12-week, double-blind period followed by an open-label extension designed to characterize 1 year of evolocumab treatment. Statin intolerance was defined as failure of two or more statins due to myalgia, myositis, or rhabdomyolysis. Eligible patients were randomized at 2:2:1:1 into four groups: 420 mg evolocumab every 4 weeks (Q4W)＋oral placebo daily, 140 mg evolocumab every 2 weeks (Q2W)＋oral placebo daily, subcutaneous (SC) placebo Q4W＋10 mg ezetimibe daily, and SC placebo Q2W＋ 10 mg ezetimibe daily.
RESULTS


Sixty-one patients were randomized to evolocumab (n=40) or ezetimibe (n=21). For the co-primary endpoints of percent change from the baseline in mean LDL-C to the mean of weeks 10 and 12 and to week 12, the evolocumab-ezetimibe treatment differences were -39.4% (95% CI, -47.2% to -31.5%) and -40.1% (95% CI, -48.7% to -31.6%), respectively (adjusted p＜0.0001). The most common adverse events were diarrhea (9.5%) and nasopharyngitis (12.5%) in the ezetimibe and evolocumab groups, respectively, during the double-blind period and nasopharyngitis (29%) during the open-label extension.
CONCLUSION


Evolocumab was superior to ezetimibe in reducing LDL-C during the 12-week double-blind period in this population of Japanese patients with statin intolerance, with efficacy and safety results maintained for 1 year.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02634580.",2020,"The most common adverse events were diarrhea (9.5%) and nasopharyngitis (12.5%) in the ezetimibe and evolocumab groups, respectively, during the double-blind period and nasopharyngitis (29%) during the open-label extension.
","['Eligible patients', 'Statin-Intolerant Hyperlipidemic Japanese Patients', 'Japanese patients with statin intolerance', 'Sixty-one patients']","['Evolocumab vs. Ezetimibe', 'ezetimibe', 'evolocumab vs. ezetimibe', 'evolocumab every 4 weeks (Q4W)＋oral placebo daily, 140 mg evolocumab every 2 weeks (Q2W)＋oral placebo daily, subcutaneous (SC) placebo Q4W＋10 mg ezetimibe daily, and SC placebo Q2W＋ 10 mg ezetimibe daily', 'evolocumab']","['diarrhea', 'Statin intolerance', 'nasopharyngitis', 'lowering low-density lipoprotein-cholesterol (LDL-C', 'LDL-C', 'mean LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",61.0,0.579447,"The most common adverse events were diarrhea (9.5%) and nasopharyngitis (12.5%) in the ezetimibe and evolocumab groups, respectively, during the double-blind period and nasopharyngitis (29%) during the open-label extension.
","[{'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Koba', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Inoue', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University.'}, {'ForeName': 'Marcoli', 'Initials': 'M', 'LastName': 'Cyrille', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'Hyoe', 'Initials': 'H', 'LastName': 'Inomata', 'Affiliation': 'Amgen Astellas BioPharma K.K.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Shimauchi', 'Affiliation': 'Amgen Astellas BioPharma K.K.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Kajinami', 'Affiliation': 'Department of Cardiology, Kanazawa Medical University.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.50963']
1068,31122717,Short period of high-intensity inspiratory muscle training improves inspiratory muscle strength in patients with chronic kidney disease on hemodialysis: a randomized controlled trial.,"BACKGROUND


Chronic kidney disease is a complex disease that impacts multiple organs and systems (including musculoskeletal and cardiorespiratory) leading to reduction of functional capacity.
OBJECTIVE


The aim of this study was to investigate the effect of a short period of high intensity inspiratory muscle training on maximum inspiratory pressure, functional capacity and endothelial function of chronic kidney disease patients on hemodialysis.
METHODS


This randomized controlled trial enrolled 25 patients who were allocated into two groups: intervention (IMTG=14) and control (CG=11) groups. Intervention patients received the exercise protocol over a period of 5 weeks, 6 times per week, with each session consisting of 5 sets of 10 repetitions with an initial load of 50% progressing to 70% of maximum inspiratory pressure , measured weekly. The primary outcome was inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function evaluated before and after the training protocol.
RESULTS


The inspiratory muscle training induced a marked improvement in maximum inspiratory pressure which was evident after the training period (mean difference 19.0cmH 2 O - 95%CI 0.4-37.5; IMTG: 102±25.7cmH 2 O vs CG: 83±19.2; p=0.046). The magnitude of maximum inspiratory pressure improvement was 33.5% at the end of the protocol for the IMTG. Functional capacity and endothelial function did not vary between or within groups.
CONCLUSION


A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).",2020,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"['chronic kidney disease patients', 'patients with chronic kidney disease on hemodialysis', 'chronic kidney disease patients on hemodialysis', '25 patients']","['high intensity inspiratory muscle training', 'high-intensity inspiratory muscle training', 'exercise protocol', 'IMTG']","['inspiratory muscle strength', 'maximum inspiratory pressure improvement', 'maximum inspiratory pressure, functional capacity and endothelial function', 'maximum inspiratory pressure', 'Functional capacity and endothelial function', 'inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",25.0,0.10348,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dipp', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: thdipp@hotmail.com.'}, {'ForeName': 'Fabrício Edler', 'Initials': 'FE', 'LastName': 'Macagnan', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jociane', 'Initials': 'J', 'LastName': 'Schardong', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael Oliveira', 'Initials': 'RO', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Luisa Cioato', 'Initials': 'LC', 'LastName': 'Lemos', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Méa', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.04.003']
1069,31125092,Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment.,"CONTEXT


Evidence for further nonvertebral fracture (NVF) reductions with long-term antiresorptive therapy in osteoporosis is lacking.
OBJECTIVE


To evaluate NVF risk reduction in subjects receiving ≤10 years of denosumab treatment.
DESIGN


Phase 3, randomized, placebo-controlled, 3-year Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial (NCT00089791) and its open-label 7-year extension (NCT00523341).
SETTING


One hundred seventy-two study centers worldwide.
PATIENTS


Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both).
INTERVENTIONS


Subjects randomly assigned 1:1 denosumab 60 mg SC Q6M (long-term) or placebo (crossover) in FREEDOM; eligible subjects could enroll in the extension to receive denosumab 60 mg SC Q6M.
MAIN OUTCOME MEASURES


NVF Exposure-adjusted subject incidence (per 100 subject-years) during denosumab treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3.
RESULTS


Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) = 0.72 (0.61 to 0.86); P < 0.001]; in long-term only were 1.98 (1.67 to 2.34) during years 1 to 3 and 1.44 (1.24 to 1.66) during years 4 to 10 [RR = 0.74 (0.60 to 0.93); P = 0.008]. combined osteonecrosis of the jaw and atypical femoral fracture rate was 0.06.
CONCLUSIONS


Long-term denosumab treatment, >3 and ≤10 years, was associated with further reductions in NVF rates compared with the first 3 years.",2019,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","['Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both', 'Osteoporosis', '4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) ', 'One hundred seventy-two study centers worldwide', 'subjects receiving ≤10 years of denosumab treatment', 'treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3']","['placebo', 'Denosumab', 'denosumab 60 mg SC Q6M (long-term) or placebo', 'denosumab 60 mg SC Q6M', 'denosumab']","['combined osteonecrosis of the jaw and atypical femoral fracture rate', 'Nonvertebral Fracture Reduction', 'NVF rates', 'NVF risk reduction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4517506', 'cui_str': '1.53'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",4074.0,0.03351,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Butler', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, Colorado.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00271']
1070,31424395,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PF-06751979, a Potent and Selective Oral BACE1 Inhibitor: Results from Phase I Studies in Healthy Adults and Healthy Older Subjects.","PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease. Two Phase I studies (NCT02509117, NCT02793232) investigated the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06751979. Single-ascending doses up to 540 mg and multiple-ascending doses up to 275 mg once daily (QD) in healthy adults, and multiple doses of 50 mg or 125 mg QD in healthy older subjects were assessed. PF-06751979 was well tolerated at all doses given, and all treatment-related adverse events (AEs) were mild to moderate. PK parameters remained consistent across the PF-06751979 QD dosing regimens, and no notable food effects were observed. PD analysis showed that PF-06751979 reduced the cerebrospinal fluid (CSF) and plasma levels of Aβ peptides in a dose-dependent manner, with the greatest reductions observed in subjects treated with 275 mg QD (approximately 92% and 93% reduction in CSF Aβ1-40 and Aβ1-42 observed at 24 h after Day 14 dose, respectively). A drug interaction study (NCT03126721) using midazolam indicated that there was no clinically meaningful effect of multiple doses of PF-06751979 100 mg QD on the PK of single-dose midazolam in healthy adults. Overall, these data suggest that PF-06751979 with daily dosing is favorable for further clinical development.",2019,"PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease.","['Healthy Adults and Healthy Older Subjects', 'healthy older subjects', 'healthy adults']",['midazolam'],"['safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06751979', 'PK parameters', 'cerebrospinal fluid (CSF) and plasma levels of Aβ peptides', 'tolerated', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PF-06751979, a Potent and Selective Oral']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007807'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",42.0,0.0293733,"PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease.","[{'ForeName': 'Ruolun', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Ahn', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Alexander', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Brodney', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Biogen Inc, Cambridge, MA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Leurent', 'Affiliation': 'Samsung Ventures, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Margolin', 'Affiliation': 'Clinical Research Solutions LLC, Cambridge, MA, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Tankisheva', 'Affiliation': 'Pfizer Clinical Research Unit Brussels, Belgium.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190228']
1071,31753895,"Efficacy of  Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study protocol.","INTRODUCTION


The healthy 'eubiosis' microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4-6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
METHODS AND ANALYSIS


A randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of  Bifidobacterium longum  and  infantis  and  Lactobacillus acidophilus  in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry.
ETHICS AND DISSEMINATION


Ethics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website (www.primal-study.de) and via social media of parent organisations.
TRIAL REGISTRATION NUMBER


DRKS00013197; Pre-results.",2019,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","['Preterm infants', 'preterm infants between 28+0\u2009and 32+6 weeks of gestation', 'preterm infants of 28+0-32+6 weeks of gestation', 'Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation', '18 German neonatal intensive care units', 'healthy term infants']","['placebo', 'Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics', 'probiotics or placebo']","['safety and efficacy', 'Side effects and adverse events']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",654.0,0.386743,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Marißen', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haiß', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Van Rossum', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Bünte', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Frommhold', 'Affiliation': ""Children's Hospital Memmingen, Memmingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gille', 'Affiliation': 'Department of Neonatology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sybelle', 'Initials': 'S', 'LastName': 'Goedicke-Fritz', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Hudalla', 'Affiliation': 'Department of Neonatology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pagel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pirr', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Siller', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Viemann', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Vens', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Inke', 'Initials': 'I', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gehring', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Bork', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Henneke', 'Affiliation': 'Insitute for Immunodeficiency (CCI) and Centre for Paediatrics and Adolescent Medicine, Medical Centre and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany christoph.haertel@uksh.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032617']
1072,30916447,Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial.,"BACKGROUND


Preoperative anxiety affects up to 65% of children who undergo anesthesia induction and often results in uncooperative behavior. Electronic devices have been used to distract children to reduce anxiety and create a more enjoyable preoperative experience. Few studies have compared the effects of different video delivery systems on preoperative anxiety.
AIMS


The primary aim was to determine if a large projection-based video screen mounted to a patient's bed decreased anxiety when compared to a tablet during mask induction of anesthesia in children from 4-10 years of age.
METHODS


We performed a prospective, randomized trial to determine differences in our primary outcome, preoperative anxiety, between the large Bedside Entertainment and Relaxation Theater (BERT) and a smaller tablet screen. Secondary outcomes included (a) induction compliance; (b) child fear; (c) frequency of emergence delirium; and (d) satisfaction.
RESULTS


In examining the primary outcome for 52 patients, there was a main effect for time on mYPAS scores, f(2, 51) = 13.18, P < 0.01. mYPAS scores significantly increased across time for both groups. The interaction for time (T0, T1 or T2) × group (BERT vs Tablet) was not significant, f(2, 51) = 1.96, P = 0.15; thus changes in mYPAS scores across time did not differ by group status. There was no significant difference in induction compliance, child fear, emergence delirium, or satisfaction between the two groups.
CONCLUSION


In a low-risk population, preoperative anxiety was low and induction compliance was high when pairing screen-based distraction interventions, regardless of size, with parental presence at induction of anesthesia.",2019,"There was no significant difference in induction compliance, child fear, emergence delirium, or satisfaction between the two groups.
","['low-risk children', 'children from 4-10\xa0years of age', '52 patients']",['passive video distraction'],"['time on mYPAS scores, f(2, 51)\xa0', 'induction compliance, child fear, emergence delirium, or satisfaction', 'interaction for time (T0, T1 or T2', 'induction compliance; (b) child fear; (c) frequency of emergence delirium; and (d) satisfaction', 'mYPAS scores']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0947157,"There was no significant difference in induction compliance, child fear, emergence delirium, or satisfaction between the two groups.
","[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Jang', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jessica Maya', 'Initials': 'JM', 'LastName': 'Hernandez', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Alexandria Joseph', 'Initials': 'AJ', 'LastName': 'George', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Caruso', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simons', 'Affiliation': 'Division of Pediatric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",Paediatric anaesthesia,['10.1111/pan.13636']
1073,31753045,Effects of biomedical messages and expert-recommended messages on reducing mental health-related stigma: a randomised controlled trial.,"AIMS


Mental health-related stigma is a major challenge associated with the huge mental health treatment gap. It has remained unclear what kind of educational content is effective in reducing the stigma. Whether biomedical messages (BMM) about mental illness are effective or harmful in decreasing stigma is controversial. To investigate whether BMM can improve practically useful knowledge of mental illness, comparably to recommended messages (RCM) advocated by experts, of types such as 'recovery-oriented', 'social inclusion/human rights' and 'high prevalence of mental illnesses' through a randomised controlled trial (RCT).
METHOD


This study is an individual-level RCT with a parallel-group design over 1 year, conducted in Tokyo, Japan. A total of 179 participants (males n = 80, mean age = 21.9 years and s.d. = 7.8) were recruited in high schools and universities, and through a commercial internet advertisement in June and July 2017, without any indication that the study appertained to mental health. Participants were allocated to the BMM and RCM groups. They underwent a 10-min intervention, and completed self-report questionnaires during baseline, post-test, 1-month follow-up and 1-year follow-up surveys. The primary outcome measures were practically useful knowledge of mental illness at the post-test survey using the Mental Illness and Disorder Understanding Scale (MIDUS). Analysis was conducted in October 2018.
RESULTS


Both groups demonstrated improved MIDUS score in the post-test survey, and showed similar intervention effects (F(1, 177) = 160.5, p < 0.001, η2 = 0.48). The effect of the interventions continued until the 1-year follow-up survey (B [95% CI] = -2.56 [-4.27, -0.85], p < 0.01), and showed no difference between groups. The reported adverse effect that BMM increase stigma was not confirmed.
CONCLUSIONS


BMM may have a positive impact on stigma, comparable to RCM. These findings may encourage reconsideration of the content of messages about mental health, as it is indicated that combining BMM and RCM might contribute to an effective anti-stigma programme.",2019,The primary outcome measures were practically useful knowledge of mental illness at the post-test survey using the Mental Illness and Disorder Understanding Scale (MIDUS).,"['179 participants (males n = 80, mean age = 21.9 years and s.d. ', '7.8) were recruited in high schools and universities, and through a commercial internet advertisement in June and July 2017, without any indication that the study appertained to mental health']","['biomedical messages and expert-recommended messages', 'BMM', 'BMM and RCM']","['BMM increase stigma', 'mental health-related stigma', 'useful knowledge of mental illness at the post-test survey using the Mental Illness and Disorder Understanding Scale (MIDUS', 'MIDUS score']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",179.0,0.190868,The primary outcome measures were practically useful knowledge of mental illness at the post-test survey using the Mental Illness and Disorder Understanding Scale (MIDUS).,"[{'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, 3-8-1 Komaba, Meguro-ku, Tokyo 153-8902, Japan.'}, {'ForeName': 'Sosei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Community Mental Health & Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8553, Japan.'}, {'ForeName': 'Kazusa', 'Initials': 'K', 'LastName': 'Ohta', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, 3-8-1 Komaba, Meguro-ku, Tokyo 153-8902, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Neuropsychiatry, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koike', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, 3-8-1 Komaba, Meguro-ku, Tokyo 153-8902, Japan.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796019000714']
1074,31112399,Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data.,"BACKGROUND


The Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials demonstrated efficacy/tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis assessed time of onset of onabotulinumtoxinA after the first treatment in total and responder populations and consistency weekly through five treatment cycles.
METHODS


In the 24-week, double-blind, placebo-controlled phase of PREEMPT, individuals were randomized 1:1 to onabotulinumtoxinA (155-195 U) or placebo every 12 weeks for two cycles. The primary pooled efficacy variable was change in headache days per 28 days at week 24. We assessed change in headache and migraine/probable migraine (hereafter migraine) days/week compared with baseline week 4.
RESULTS


Baseline mean (SD) headache days/week (week 4 of baseline) for onabotulinumtoxinA (n = 688) and placebo (n = 696) were similar (4.8 [1.6] vs. 4.8 [1.6] days/week, respectively), as were migraine days/week (4.6 [1.7] vs. 4.6 [1.7] days/week). The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week [  p  < 0.001]). Headache and migraine days decreased in onabotulinumtoxinA responders beginning 1 week after treatment 1.
CONCLUSIONS


Treatment with onabotulinumtoxinA is associated with significant reductions in headache and migraine days/week at week 1, persisting after week 3, compared with placebo. Combined with earlier reports showing onabotulinumtoxinA treatment results in a persistent and progressive reduction in headache days over 56 weeks, it is suggested peak benefit may require multiple treatments.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT00156910 and NCT00168428.",2019,"The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week",['adults with chronic migraine'],"['placebo', 'Migraine Prophylaxis Therapy (PREEMPT', 'onabotulinumtoxinA']","['headache days', 'time of onset of onabotulinumtoxinA', 'headache and migraine/probable migraine', 'Baseline mean (SD) headache', 'headache', 'headache and migraine days/week', 'Headache and migraine days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142085', 'cui_str': 'Migraine prophylaxis (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0676278', 'cui_str': 'preempt'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}]",696.0,0.232294,"The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': '1 Deparment of Neurology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': '2 Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': '3 Montefiore Headache Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': '4 Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Aubrey Manack', 'Initials': 'AM', 'LastName': 'Adams', 'Affiliation': '4 Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': '5 University of Duisbury-Essen, Essen, Germany.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102418825382']
1075,30506299,Patient intermittent epidural boluses (PIEB) plus very low continuous epidural infusion (CEI) versus patient-controlled epidural analgesia (PCEA) plus continuous epidural infusion (CEI) in primiparous labour: a randomized trial.,"Epidural maintenance technique for labour analgesia updates constantly. Thanks to infusion pumps, the recently developed programmed intermittent epidural bolus (PIEB) may reduce the use of anesthetic drugs and minimize unintended consequences such as cardio or neurotoxicity. Nevertheless, it is not yet a general practice. So far, there are no comparative studies in the literature that address levobupivacaine-based CEI + PCEA versus CEI + PIEB + PCEA. A randomized double-blind trial was carried out to evaluate if PIEB could reduce local anesthetic use compare to PCEA. Primiparous pregnant patients were divided into two groups: PIEB group (continuous infusion plus intermittent automatic doses) and PCEA group (continuous infusion plus PCEA). The primary objective was to analyze the differences between both groups regarding levobupivacaine total dose. The secondary objectives were to find out the differences concerning pain control, motor blockage, satisfaction score, labour time and delivery outcomes. Statistical analyses were done by protocol. The study recruited 200 patients (103 PIEB, 97 PCEA). The total dose administered was significantly higher in PIEB group: PCEA group 52.97 mg, IC 95% 45.65-60.28 mg and PIEB group 62.04 mg, IC 95% 55.46-68.61 mg (p = 0.021). PIEB group required fewer top up boluses (median value1; range 0-2) than CEI + PCEA group (median value 6; range 3-9) p < 0.05. Satisfaction scores were higher in PIEB group (p = 0.039, CI 95% 1.23-1.42). CEI + PIEB was found to be a good alternative to CEI + PCEA with very high rates of satisfaction in both groups although it was higher in PIEB group. PIEB group required fewer PCEA boluses. Further studies are needed to determine the best approach for epidural pain management.Clinical Trial Number and Registry URL: NCT03133091 ( https://clinicaltrials.gov/ct2/show/NCT03133091?term=MB+Rodriguez&rank=1) .",2019,"Satisfaction scores were higher in PIEB group (p = 0.039, CI 95% 1.23-1.42).","['200 patients (103 PIEB, 97 PCEA', 'Primiparous pregnant patients', 'primiparous labour']","['PIEB group (continuous infusion plus intermittent automatic doses) and PCEA group (continuous infusion plus PCEA', 'levobupivacaine', 'Patient intermittent epidural boluses (PIEB) plus very low continuous epidural infusion (CEI) versus patient-controlled epidural analgesia (PCEA) plus continuous epidural infusion (CEI']","['pain control, motor blockage, satisfaction score, labour time and delivery outcomes', 'Satisfaction scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",200.0,0.107699,"Satisfaction scores were higher in PIEB group (p = 0.039, CI 95% 1.23-1.42).","[{'ForeName': 'Maria Belen', 'Initials': 'MB', 'LastName': 'Rodríguez-Campoó', 'Affiliation': 'Department of Anesthesia and Surgical Critical Care, Hospital Universitario Rio Hortega (HURH), C/Dulzaina 2, 47012, Valladolid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Curto', 'Affiliation': 'Department of Anesthesia and Surgical Critical Care, Hospital Universitario Rio Hortega (HURH), C/Dulzaina 2, 47012, Valladolid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Research Unit. Hospital Universitario Rio Hortega (HURH), C/Dulzaina2, 47012, Valladolid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia and Surgical Critical Care, Hospital Universitario Rio Hortega (HURH), C/Dulzaina 2, 47012, Valladolid, Spain. cesar.aldecoa@gmail.com.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-018-0229-x']
1076,31115034,Ketoprofen and tramadol pharmacokinetics in patients with chronic pancreatitis.,"OBJECTIVE


Chronic pancreatitis (CP) is a disease leading to irreversible pancreas dysfunction. One of the main symptoms is pain. Many patients require pharmacological therapy which should be started with paracetamol or, in selected groups of patients, ketoprofen. If the effect of ketoprofen is irrelevant, patients receive tramadol. The aim of this study is the evaluation of ketoprofen and tramadol pharmacokinetics (PK) in CP patients.
PATIENTS AND METHODS


36 patients were divided into two groups: I - receiving ketoprofen (n=18; mean [SD] age, 48.61 [13.32] years; weight, 73.28 [20.48] kg), II - receiving tramadol (n=18; mean [SD] age, 46.78 [10.28] years; weight, 74.22 [14.04] kg, and BMI (Body Mass Index), 24.61 [4.51] kg/m2). The plasma concentrations of ketoprofen and tramadol with its active metabolite M1 (0-desmethyltramadol) were measured with the validated high-performance liquid chromatography method.
RESULTS


The main PK parameters for ketoprofen were as follows: Cmax (maximum plasma concentration), 3.41 [2.32] mg/L; AUC0-inf (area under the plasma concentration-time curve from time zero to infinity), 10.45 [5.57] mg⋅h/L; tmax (time to first occurrence of Cmax), 1.94 [1.25] h; Cl (clearance), 0.199 [0.165] L/kg·h, and Vd/kg (volume of distribution per kilogram of body weight), 0.71 [0.58] L/kg. The main PK parameters for TRM and M1 were as follows: Cmax, 226.4 [80.5] and 55.6 [23] ng/mL; AUC0-inf, 1903.3 [874.8] and 790.4 [512.4] ng⋅h/mL; tmax, 1.78 [0.73] and 2.67 [1.19] h, respectively.
CONCLUSIONS


Chronic pancreatitis led to a decrease in the total amount of absorbed ketoprofen. Consequently, the analgesic effect of the drug may be weaker. Cmax of tramadol for most CP patients was within the therapeutic range associated with its analgesic activity. M1/TRM ratios for Cmax and AUC were unchanged.",2019,M1/TRM ratios for Cmax and AUC were unchanged.,"['patients with chronic pancreatitis', 'CP patients', '10.28] years; weight, 74.22 [14.04] kg, and BMI (Body Mass Index), 24.61', 'n=18; mean [SD] age, 48.61 [13.32] years; weight, 73.28 [20.48] kg), II - receiving', '36 patients']","['ketoprofen', 'tramadol', 'ketoprofen and tramadol pharmacokinetics (PK', 'paracetamol', 'Cmax of tramadol', 'Ketoprofen']","['total amount of absorbed ketoprofen', 'plasma concentrations of ketoprofen and tramadol with its active metabolite M1 (0-desmethyltramadol', 'Cmax (maximum plasma concentration', 'M1/TRM ratios for Cmax and AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",36.0,0.0508273,M1/TRM ratios for Cmax and AUC were unchanged.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Siepsiak-Połom', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Gdańsk, Gdańsk, Poland. mag.siepsiak@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Szałek', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Porażka', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karbownik', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Grabowski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mziray', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Adrych', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Grześkowiak', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201905_17835']
1077,30859428,Conservative Treatment in Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment.,"BACKGROUND


Recently published studies advocate a conservative approach with observation and antibiotic treatment in diverticulitis patients with pericolic air on computed tomography (CT). The primary aim of this study was to assess the clinical course of initially conservatively treated diverticulitis patients with isolated pericolic air and to identify risk factors for conservative treatment failure. The secondary aim was to assess the outcome of non-antibiotic treatment.
METHODS


Patient data from a retrospective cohort study on risk factors for complicated diverticulitis were combined with data from the DIABOLO trial, a randomised controlled trial comparing non-antibiotic with antibiotic treatment in patients with uncomplicated diverticulitis. The present study identified all patients with Hinchey 1A diverticulitis with isolated pericolic air on CT. Pericolic air was defined as air located < 5 cm from the affected segment of colon. The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation. A multivariable logistic regression of clinical, radiological and laboratorial parameters with respect to treatment failure was performed.
RESULTS


A total of 109 patients were included in the study. Fifty-two (48%) patients were treated with antibiotics. Nine (8%) patients failed conservative management, seven (13%) in the antibiotic treatment group and two (4%) in the non-antibiotic group (p = 0.083). Only (increased) CRP level at presentation was an independent predictor for treatment failure.
CONCLUSIONS


Conservative treatment in diverticulitis patients with isolated pericolic air is a suitable treatment strategy. Moreover, non-antibiotic treatment might be reasonable in selected patients.",2019,The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation.,"['diverticulitis patients with pericolic air on computed tomography (CT', 'patients with uncomplicated diverticulitis', 'patients with Hinchey 1A diverticulitis with isolated pericolic air on CT', 'Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment', 'initially conservatively treated diverticulitis patients with isolated pericolic air and to identify risk factors for conservative treatment failure', 'Patient data from a retrospective cohort study on risk factors for complicated diverticulitis', 'A total of 109 patients were included in the study']","['antibiotic treatment', 'antibiotics']","['CRP level', 'failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery']","[{'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0344096', 'cui_str': 'Drainage of abscess (procedure)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",109.0,0.054334,The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation.,"[{'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Bolkenstein', 'Affiliation': 'University of Twente, 5, Drienerlolaan, 7522, NB, Enschede, The Netherlands. he.bolkenstein@meandermc.nl.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'van Dijk', 'Affiliation': 'Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'E C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medisch Centrum, 3800, BM, Amersfoort, The Netherlands.'}, {'ForeName': 'B G F', 'Initials': 'BGF', 'LastName': 'Heggelman', 'Affiliation': 'Department of Radiology, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'C M A', 'Initials': 'CMA', 'LastName': 'Hoeks', 'Affiliation': 'Department of Radiology, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'I A M J', 'Initials': 'IAMJ', 'LastName': 'Broeders', 'Affiliation': 'Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04153-9']
1078,30995176,"Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.","PURPOSE


A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.
PATIENTS AND METHODS


Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.
RESULTS


The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases.
CONCLUSION


IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.",2019,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","['patients with relapsed chronic lymphocytic leukemia (CLL', 'Patients With Relapsed Chronic Lymphocytic Leukemia', 'Patients', '110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study', 'patients with relapsed CLL']","['IDELA', 'Rituximab With or Without Idelalisib', 'IDELA monotherapy', 'placebo plus rituximab', 'IDELA-plus-rituximab (IDELA/R', 'idelalisib (IDELA) plus rituximab', 'rituximab', 'rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo']","['PFS and OS', 'grade and grade 3 or greater colitis', 'pneumonitis', 'progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety', 'diarrhea', 'median OS', 'ORR', 'median PFS', 'incidence of elevated hepatic aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",110.0,0.412396,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': '1 Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': '2 Stanford School of Medicine, Stanford, CA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': '3 Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '4 Georgetown University Hospital, Washington DC.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': '5 Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""6 St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': '7 Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '8 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': '9 University of California, San Diego, Moores Cancer Center, La Jolla, CA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': '10 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': '11 Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': '12 David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ervin', 'Affiliation': '13 Venice Regional Bayfront Health, Venice, FL.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lamanna', 'Affiliation': '14 Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': '15 Centre Hospitalier Lyon-Sud, Pierre Benite, France.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': '16 University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': '17 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': '18 Ulm University, Ulm, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': '21 University of California, Irvine, Orange, CA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': '18 Ulm University, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01460']
1079,31115020,"The expression of TRPM7 in serum of patients with sepsis, its influences on inflammatory factors and prognosis, and its diagnostic value.","OBJECTIVE


This study aimed to investigate the expression of TRPM7 in the serum of patients with sepsis and its influences on inflammatory factors and prognosis.
PATIENTS AND METHODS


A prospective analysis was performed. 78 patients with sepsis were enrolled in the experimental group and treated from May 2015 to April 2017 in the Emergency Department of The Second Hospital of Dalian Medical University, and 75 healthy people were collected in the control group and received physical examinations during the same period. Real-time quantitative PCR was used to detect the relative expression of TRPM7, and sandwich enzyme-linked immunosorbent assay (ELISA) was applied to measure the serum expression levels of TNF-α, IL-6, and IL-10 in patients. Besides, the receiver operating characteristic (ROC) curve was drawn to analyze the diagnostic value of TRPM7.
RESULTS


The serum level of TRPM7 mRNA in the experimental group was higher than that in the control group (p<0.05). The serum levels of TNF-α, IL-6, and IL-10 in the experimental group were significantly higher than those in the control group (p<0.05). The optimal cut-off point value for the diagnosis of sepsis was 0.841; the specificity was 86%, and the sensitivity was 99%. Based on the survival data of the experimental group and the average expression level of TRPM7 which was 1.38, patients with a TRPM7 expression level less than 1.38 were divided into the low expression group, while those with a TRPM7 expression level equal or more than 1.38 were divided into the high expression group. The survival rate of the high expression group was significantly lower than that of the low expression group (p<0.05).
CONCLUSIONS


In summary, TRPM7, with high expression level in the serum of patients with sepsis is expected to be a potential prognostic indicator for sepsis.",2019,"The serum levels of TNF-α, IL-6, and IL-10 in the experimental group were significantly higher than those in the control group (p<0.05).","['patients with sepsis', '78 patients with sepsis were enrolled in the experimental group and treated from May 2015 to April 2017 in the Emergency Department of The Second Hospital of Dalian Medical University, and 75 healthy people']",[],"['serum expression levels of TNF-α, IL-6, and IL-10', 'survival rate', 'relative expression of TRPM7, and sandwich enzyme-linked immunosorbent assay ', 'receiver operating characteristic (ROC) curve', 'serum level of TRPM7 mRNA', 'serum levels of TNF-α, IL-6, and IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4543503', 'cui_str': 'Sandwich (substance)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}]",78.0,0.0157248,"The serum levels of TNF-α, IL-6, and IL-10 in the experimental group were significantly higher than those in the control group (p<0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency, The Second Hospital of Dalian Medical University, Dalian, P.R. China. ypz326@163.com.'}, {'ForeName': 'S-Y', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'X-D', 'Initials': 'XD', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'C-W', 'Initials': 'CW', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Y-F', 'Initials': 'YF', 'LastName': 'Liu', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201905_17821']
1080,31115032,The efficacy of simendan in the treatment of acute heart failure and its impact on NT-proBNP.,"OBJECTIVE


Simendan is a calcium sensitizer that enhances myocardial contractility but does not affect ventricular diastole. Simendan also has a vasodilatation effect, which causes coronary artery resistance and venous volume blood vessel relax, thereby improving coronary blood supply. This study adopted simendan on the basis of conventional anti-heart failure treatment to explore a new approach for the treatment of heart failure.
PATIENTS AND METHODS


Eighty patients with heart failure were randomly and equally divided into an observation group and control group according to the digital table method. The control group was given a conventional anti-heart failure treatment. The observation group was treated with simendan on the basis of the control group. The left ventricular ejection fraction (LEVF), stroke volume (SV), NT-proBNP, K+, and Ca2+ were measured before and after the treatment. The clinical efficacy and adverse reactions after treatment were compared. The 6-minute walking distance (6MWT) was recorded on the 60th day after treatment.
RESULTS


There were no significant differences in LVEF and SV between the two groups before the treatment. They were significantly increased after treatment and were significantly higher in the observation group than that in the control group (p < 0.05). The total effective rate in the observation group (92.50%) was significantly higher than that in the control group (67.50%). There was no statistical difference in the occurrence of adverse reactions between the two groups (p > 0.05). The 6MWT in the observation group was 452.63±86.51 meters, which was significantly higher than that in the control group (366.85±70.46 meters) (p < 0.05). There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05). The plasma NT-proBNP level was significantly lower in the observation group than that in the control group after treatment (p < 0.05). Serum K+ and Ca2+ were not significantly changed after treatment in the control group (p > 0.05). Serum K+, but not Ca2+, was significantly elevated in the observation group.
CONCLUSIONS


Simendan can significantly reduce plasma NT-proBNP level; thus, it is relatively safe and effective for the treatment of acute heart failure (AHF).",2019,There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05).,['Eighty patients with heart failure'],"['conventional anti-heart failure treatment', 'simendan']","['clinical efficacy and adverse reactions', 'occurrence of adverse reactions', 'LVEF and SV', 'Serum K+ and Ca2', 'Serum K', '6-minute walking distance (6MWT', 'myocardial contractility', 'total effective rate', 'plasma NT-proBNP level', 'plasma NT-proBNP levels', 'left ventricular ejection fraction (LEVF), stroke volume (SV), NT-proBNP, K+, and Ca2']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0287806', 'cui_str': '((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2603574', 'cui_str': 'Ca(BD4)2'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}]",80.0,0.0174552,There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of General Medicine, Affiliated Hospital of Hebei University of Engineering, Handan, Heibei, China. rtlb5n1b7r3f@sina.com.'}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z-Y', 'Initials': 'ZY', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201905_17833']
1081,30449171,"Randomized Study of the Effect of Dietary Counseling During Adjuvant Chemotherapy on Chemotherapy Induced Nausea and Vomiting, and Quality of Life in Patients With Breast Cancer.","Patients with breast cancer (PsBC) usually face with chemotherapy induced nausea and vomiting (CINV). The aim of this study was to assess the impact of nutritional counseling on CINV and quality of life (QoL) of PsBC. 150 PsBC were randomly assigned for receiving a personalized diet, which contained 1.2-1.5 g/kg of protein, 30% of energy from fat and 55-60% of energy from carbohydrate, a face to face nutrition education, and a pamphlet which contained beneficial nutrition information to reduce the severity of CINV before each chemotherapy session for three times (n = 75) or regular care (n = 75). CINV, QoL, and dietary intake were evaluated after each chemotherapy session. Nausea rating index, overall nausea index, and visual analog scale (P < 0.001) were dramatically lower in the intervention group. Global health status/QoL as well as physical functioning, role functioning, emotional functioning, and cognitive functioning (P < 0.001) were significantly better in the intervention group. Patients in the control group experienced more fatigue, nausea and vomiting, pain, dyspnea, loss of appetite, constipation, and diarrhea (P < 0.001). Nutrition counseling during adjuvant chemotherapy among PsBC reduced the occurrence of CINV and led to significant improvements in the QoL.",2019,"Nausea rating index, overall nausea index, and visual analog scale (P < 0.001) were dramatically lower in the intervention group.","['Patients with breast cancer (PsBC', 'Patients With Breast Cancer', '150 PsBC']","['personalized diet, which contained 1.2-1.5\u2009g/kg of protein, 30% of energy from fat and 55-60% of energy from carbohydrate, a face to face nutrition education, and a pamphlet which contained beneficial nutrition information', 'Dietary Counseling', 'nutritional counseling']","['Global health status/QoL as well as physical functioning, role functioning, emotional functioning, and cognitive functioning', 'CINV, QoL, and dietary intake', 'nausea and vomiting (CINV', 'occurrence of CINV', 'Nausea and Vomiting, and Quality of Life', 'fatigue, nausea and vomiting, pain, dyspnea, loss of appetite, constipation, and diarrhea', 'Nausea rating index, overall nausea index, and visual analog scale', 'CINV and quality of life (QoL) of PsBC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",150.0,0.0481479,"Nausea rating index, overall nausea index, and visual analog scale (P < 0.001) were dramatically lower in the intervention group.","[{'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'a Breast Disease Department , Breast Cancer Research Center, Motamed Cancer Institute, ACECR , Tehran , Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'b Quality of Life Department , Breast Cancer Research Center, Motamed Cancer Institute, ACECR , Tehran , Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'c Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'RazmPoosh', 'Affiliation': 'd Nutrition and Food Security Research Center , Shahid Sadoughi University of Medical Sciences , Yazd , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamari', 'Affiliation': 'f School of Nutritional Sciences and Dietetics , Tehran University of Medical Science , Tehran , Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Abdollahi', 'Affiliation': 'c Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': 'g Food Security Research Center, School of Nutrition and Food Sciences , Isfahan University of Medical Sciences , Isfahan , Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'c Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}]",Nutrition and cancer,['10.1080/01635581.2018.1527375']
1082,31678952,Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.,"INTRODUCTION


Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke.
METHODS AND ANALYSIS


The proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences.
TRIAL REGISTRATION NUMBER


NCT03730701.",2019,"Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies.","['Persons at risk of stroke (n=60', 'persons at risk of stroke']",['combining group meetings and online resources to support self-management of lifestyle change'],"['stroke risk, lifestyle habits and healthy activity patterns']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0789784,"Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies.","[{'ForeName': 'Ann-Helen', 'Initials': 'AH', 'LastName': 'Patomella', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden ann-helen.patomella@ki.se.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Guidetti', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Mälstam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Eriksson', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Bergström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Åkesson', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kottorp', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Asaba', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031984']
1083,31013172,Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma.,"PURPOSE


SARC024 is a phase II clinical trial of the multikinase inhibitor regorafenib in specific sarcoma subtypes, including advanced osteosarcoma. We hypothesized that regorafenib would improve progression-free survival (PFS) in patients with sarcoma and report the results of the osteosarcoma cohort.
PATIENTS AND METHODS


This trial enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy. Patients were randomly assigned at a ratio of one to one to regorafenib or placebo. Crossover was allowed at time of disease progression. PFS was the primary end point of the study, which was powered to detect a difference of at least 3 months in median PFS.
RESULTS


Forty-two patients from 12 centers were enrolled between September 2014 and May 2018. Median age was 37 years (range, 18 to 76 years). Patients had received an average of 2.3 prior therapy regimens. Ten patients receiving placebo crossed over to active drug at time of progression. Study enrollment was stopped early, after a data safety monitoring committee review. Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017). In the context of the crossover design, there was no statistically significant difference in overall survival. Fourteen (64%) of 22 patients initially randomly assigned to regorafenib experienced grade 3 to 4 events attributed to treatment, including one grade 4 colonic perforation.
CONCLUSION


The study met its primary end point, demonstrating activity of regorafenib in patients with progressive metastatic osteosarcoma. No new safety signals were observed. Regorafenib should be considered a treatment option for patients with relapsed metastatic osteosarcoma.",2019,"Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017).","['Patients With Metastatic Osteosarcoma', 'enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy', 'Median age was 37 years (range, 18 to 76 years', 'Forty-two patients from 12 centers were enrolled between September 2014 and May 2018', 'patients with relapsed metastatic osteosarcoma', 'patients with sarcoma', 'patients with progressive metastatic osteosarcoma']","['regorafenib or placebo', 'regorafenib', 'placebo', 'Regorafenib']","['activity of regorafenib', 'progression-free survival (PFS', 'PFS', 'overall survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278512', 'cui_str': 'Metastatic osteosarcoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",42.0,0.260789,"Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017).","[{'ForeName': 'Lara E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': '1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bolejack', 'Affiliation': '2 Cancer Research and Biostatistics, Seattle, WA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': '1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': '3 Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': '4 Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Sant', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': '5 Sarcoma Oncology Research Center, Santa Monica, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Agulnik', 'Affiliation': '6 Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Livingston', 'Affiliation': '7 Levine Cancer Institute, Charlotte, NC.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Reed', 'Affiliation': '8 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Keedy', 'Affiliation': '9 Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': '10 Indiana University, Bloomington, IN.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Okuno', 'Affiliation': '11 Mayo Clinic Rochester, Rochester, MN.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Reinke', 'Affiliation': '12 Sarcoma Alliance for Research Through Collaboration, Ann Arbor, MI.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': '13 Duke Cancer Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': '14 Mayo Clinic Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""15 Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': '16 Monter Cancer Center, Northwell Health, Lake Success, NY, and Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02374']
1084,30705040,Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial.,"PURPOSE


To compare the effectiveness of intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB) administered preoperatively to patients undergoing pars plana vitrectomy (PPV) for severe manifestations of proliferative diabetic retinopathy (PDR).
DESIGN


Randomised clinical trial (RCT).
METHODS


Two hundred and six patients with PDR-related complications requiring PPV were randomised into one of two treatment groups: Group A received IVZ (1.25 mg/0.05 mL) 1-10 days before PPV, while Group B received IVB (1.25 mg/0.05 mL) 1-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6 month study interval.
RESULTS


One hundred and seventy three subjects underwent PPV and completed the 6-month follow-up interval. Group A subjects had better BCVA at 6 months (p=0.0035), shorter surgical times (p=0.0013) and were less likely to have a recurrence of vitreous haemorrhaging in the postoperative period (p=0.0101) when compared with subjects in Group B. There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
CONCLUSIONS


This RCT demonstrated better final visual outcomes, shorter operating times and less vitreous haemorrhage recurrences in the postoperative period when subjects received IVZ compared to IVB prior to PPV for the treatment of PDR-related complications.",2019,"There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
","['One hundred and seventy three subjects underwent', 'administration prior to diabetic vitrectomy', 'patients undergoing pars', 'Two hundred and six patients with PDR-related complications requiring PPV']","['intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB', 'IVZ', 'plana vitrectomy (PPV', 'PPV', 'Ziv-aflibercept versus bevacizumab']","['recurrence of vitreous haemorrhaging', 'baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV', 'final visual outcomes', 'vitreous haemorrhage recurrences', 'best-corrected visual acuity (BCVA', 'BCVA', 'shorter surgical times', 'perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6\u2009month study interval']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C3485619', 'cui_str': 'ziv-aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",206.0,0.163365,"There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Aleman', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castillo Velazquez', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México.'}, {'ForeName': 'Sloan W', 'Initials': 'SW', 'LastName': 'Rush', 'Affiliation': 'Panhandle Eye Group, Amarillo, Texas, USA.'}, {'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Rush', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México ryanbradfordrush21@hotmail.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313313']
1085,30746574,Ergonomics in handheld and robot-assisted camera control: a randomized controlled trial.,"BACKGROUND


Laparoscopic surgery potentially increases the physical burden to operating theater personnel and can cause physical discomfort. This study aims to evaluate if a robotic camera holder (AutoLap™ system) can improve ergonomics for the surgeon and the camera assistant during laparoscopic procedures.
METHODS


A total of thirty cases were included and randomized (15 AutoLap™, 15 control). Five types of surgery were included: right hemicolectomy, fundoplication, sigmoid resection, rectopexy, and low anterior resection. The posture of the surgeon and assistant was photographed during predefined steps of the procedure. MATLAB was used to calculate angles relevant for the RULA score. The RULA score is a validated method to evaluate body posture, force and repetition of the upper extremities. Two investigators assessed the RULA score independently. Three subjective questionnaires (SMEQ, NASA TLX, and LED) were used to assess mental and physical discomfort.
RESULTS


No differences in patient characteristics were observed. Sixteen fundoplications, seven right hemicolectomies, five sigmoid resections, one rectopexy, and one low anterior resection were included. The mean RULA score of the surgeon was comparable in both groups, 2.58 (AutoLap™) versus 2.72 (control). The mean RULA score of the assistant was significantly different in both groups, with 2.55 (AutoLap™) versus 3.70 (control) (p = 0.001). The inter-observer variability (ICC) was excellent with 0.93 (surgeon) and 0.97 (assistant). The questionnaires showed a significant difference in physical discomfort for the assistant. The LED and SMEQ score were significantly lower in the robotic group. The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain.
CONCLUSION


Use of the AutoLap™ system shows improvement in ergonomics and posture of the first assistant, and ergonomics of the surgeon are not affected. Furthermore, the subjective work load is significantly reduced by using a robotic camera holder.
TRIAL REGISTRATION NUMBER


NCT0339960, https://clinicaltrials.gov/ct2/show/study/NCT03339960?term=autolap&rank=5 .",2019,"The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain.
","['A total of thirty cases were included and randomized (15 AutoLap™, 15 control', 'Sixteen fundoplications, seven right hemicolectomies, five sigmoid resections, one rectopexy, and one low anterior resection were included', 'Five types of surgery were included: right hemicolectomy, fundoplication, sigmoid resection, rectopexy, and low anterior resection']","['Laparoscopic surgery', 'robotic camera holder (AutoLap™ system', 'handheld and robot-assisted camera control']","['physical discomfort', 'mean RULA score of the assistant', 'subjective questionnaires (SMEQ, NASA TLX, and LED', 'inter-observer variability (ICC', 'RULA score', 'LED and SMEQ score', 'mean RULA score of the surgeon']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0546535', 'cui_str': 'Hemicolectomy'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0193176', 'cui_str': 'Proctopexy (procedure)'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy (procedure)'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C1551377', 'cui_str': 'Holder (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021713', 'cui_str': 'Interobserver Variation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]",30.0,0.0744583,"The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain.
","[{'ForeName': 'Paul J M', 'Initials': 'PJM', 'LastName': 'Wijsman', 'Affiliation': 'Department of Surgery, Meander Medical Center, Maatweg 3, Amersfoort, The Netherlands. pjm.wijsman@meandermc.nl.'}, {'ForeName': 'Lennert', 'Initials': 'L', 'LastName': 'Molenaar', 'Affiliation': 'Department of Surgery, Meander Medical Center, Maatweg 3, Amersfoort, The Netherlands.'}, {'ForeName': 'Cas D P', 'Initials': 'CDP', 'LastName': ""Van't Hullenaar"", 'Affiliation': 'Department of Surgery, Meander Medical Center, Maatweg 3, Amersfoort, The Netherlands.'}, {'ForeName': 'Bas S T', 'Initials': 'BST', 'LastName': 'van Vugt', 'Affiliation': 'Department of Surgery, Wilhelmina Hospital Assen, Assen, The Netherlands.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Bleeker', 'Affiliation': 'Department of Surgery, Wilhelmina Hospital Assen, Assen, The Netherlands.'}, {'ForeName': 'Werner A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's Hertogenbosch, The Netherlands.""}, {'ForeName': 'Ivo A M J', 'Initials': 'IAMJ', 'LastName': 'Broeders', 'Affiliation': 'Department of Surgery, Meander Medical Center, Maatweg 3, Amersfoort, The Netherlands.'}]",Surgical endoscopy,['10.1007/s00464-019-06678-1']
1086,30819688,Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results.,"AIM


To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO).
METHODS


Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study.
RESULTS


61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04).
CONCLUSIONS


When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.",2019,"At baseline, both groups were similar in terms of BCVA and CMT (p>0.2).","['eyes with diabetic macular oedema undergoing cataract surgery', '61 eyes of 58 patients were enrolled', 'patients with diabetic macular oedema (DMO', 'Patients with visually significant cataract and centre-involving DMO (either current or prior']","['intravitreous bevacizumab (BVB) 1.25', 'triamcinolone acetonide (TA', 'intravitreous BVB 1.25\u2009mg or TA 4\u2009mg at the time of cataract surgery', 'triamcinolone', 'intravitreal bevacizumab']","['vision', 'changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT', 'CMT', 'TA and BVB improved visual outcomes', 'mean letter gain']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",58.0,0.188876,"At baseline, both groups were similar in terms of BCVA and CMT (p>0.2).","[{'ForeName': 'Rathika', 'Initials': 'R', 'LastName': 'Kandasamy', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Rogers', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sukhpal Singh', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sanjeewa', 'Initials': 'S', 'LastName': 'Wickremasinghe', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Al-Qureshi', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia limllp@unimelb.edu.au.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313437']
1087,31609772,Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial.,"OBJECTIVES


To assess the impact of early triggered palliative care consultation on the outcomes of high-risk ICU patients.
DESIGN


Single-center cluster randomized crossover trial.
SETTING


Two medical ICUs at Barnes Jewish Hospital.
PATIENTS


Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality.
INTERVENTIONS


The medical ICUs were randomized to intervention or usual care followed by washout and crossover, with independent assignment of patients to each ICU at admission. Intervention arm patients received a palliative care consultation from an interprofessional team led by board-certified palliative care providers within 48 hours of ICU admission.
MEASUREMENTS AND MAIN RESULTS


Ninety-seven patients (48.7%) were assigned to the intervention and 102 (51.3%) to usual care. Transition to do-not-resuscitate/do-not-intubate occurred earlier and significantly more often in the intervention group than the control group (50.5% vs 23.4%; p < 0.0001). The intervention group had significantly more transfers to hospice care (18.6% vs 4.9%; p < 0.01) with fewer ventilator days (median 4 vs 6 d; p < 0.05), tracheostomies performed (1% vs 7.8%; p < 0.05), and postdischarge emergency department visits and/or readmissions (17.3% vs 38.9%; p < 0.01). Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group. There was no significant difference in ICU length of stay (median 5 vs 5.5 d), hospital length of stay (median 10 vs 11 d), in-hospital mortality (22.6% vs 29.4%), or 30-day mortality between groups (35.1% vs 36.3%) (p > 0.05).
CONCLUSIONS


Early triggered palliative care consultation was associated with greater transition to do-not-resuscitate/do-not-intubate and to hospice care, as well as decreased ICU and post-ICU healthcare resource utilization. Our study suggests that routine palliative care consultation may positively impact the care of high risk, critically ill patients.",2019,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","['high-risk ICU patients', 'Two medical ICUs at Barnes Jewish Hospital', 'Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality']",['palliative care consultation from an interprofessional team led by board-certified palliative care providers'],"['ICU length of stay', 'postdischarge emergency department visits and/or readmissions', 'total operating cost', 'hospital mortality', 'transfers to hospice care', 'hospital length of stay', '30-day mortality', 'medical ICU', 'operating costs']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",97.0,0.0982293,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Duke Palliative Care, Department of Medicine, Duke University and Health System, Durham, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buettner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pollard', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Muir', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Kolekar', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dans', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004016']
1088,31082669,Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial.,"PURPOSE


Radium 223 dichloride (radium-223) is an alpha particle-emitting bone-directed therapy that prolongs overall survival in men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is an antimicrotubule cytotoxic agent that improves survival in mCRPC. We investigated whether combining these potentially cross-sensitising agents to dually target tumour and bone would be safe and effective.
PATIENTS AND METHODS


Phase 1 was a dose escalation study to define a recommended phase 2 dose (RP2D) of docetaxel and radium-223. In phase 2a, patients were randomised 2:1 to the recommended combination regimen or docetaxel at a dose of 75 mg/m 2  every 3 weeks (q3w). Patients with bone-predominant mCRPC were eligible. End-points were safety, efficacy and treatment-related changes in serum and imaging biomarkers.
RESULTS


Twenty patients were enrolled in phase 1; 53 patients were randomised in phase 2a: 36 to combination treatment and 17 to docetaxel alone. The RP2D for the combination was radium-223 55 kBq/kg every six weeks × 5 doses, plus docetaxel 60 mg/m 2  q3w × 10 doses. Febrile neutropenia was dose limiting. A higher rate of febrile neutropenia was seen in the docetaxel monotherapy arm (15% vs 0%); the safety profile of the treatment groups was otherwise similar. The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
CONCLUSIONS


Radium-223 in combination with docetaxel at the RP2D was well tolerated. Exploratory efficacy data suggested enhanced antitumour activity for the combination relative to docetaxel alone. Comparative studies with end-points of clinical benefit are warranted. ClinicalTrials.gov number: NCT01106352.",2019,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","['patients with castration-resistant prostate cancer and bone metastases', 'men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC', 'Twenty patients were enrolled in phase 1; 53 patients', 'Patients with bone-predominant mCRPC were eligible']","['Radium 223 dichloride', 'plus docetaxel 60\xa0mg/m 2  q3w', 'Radium-223 in combination with docetaxel', 'docetaxel', 'docetaxel alone', 'docetaxel and radium-223', 'Docetaxel']","['tolerated', 'alkaline phosphatase', 'antitumour activity', 'safety profile', 'Febrile neutropenia', 'rate of febrile neutropenia', 'durable suppression of prostate-specific antigen', 'safety, efficacy\xa0and treatment-related changes in serum and imaging biomarkers', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",20.0,0.0447673,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: morrism@mskcc.org.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'NorthShore Medical Group, NorthShore University Health System, Evanston Hospital Kellogg Cancer Center, Evanston, IL, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Pandit-Taskar', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'Deandreis', 'Affiliation': 'Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': ""Department of Imaging, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Vesselle', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Carrasquillo', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.007']
1089,31059974,Prognostic role of serum thymidine kinase 1 activity in patients with hormone receptor-positive metastatic breast cancer: Analysis of the randomised phase III Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT).,"BACKGROUND


Thymidine kinase 1 (TK1) plays a critical role in DNA synthesis and cell proliferation. Recent studies have shown potential for serum TK1 activity (sTKa) as a prognostic marker and indicator of early response to endocrine therapy in advanced breast cancer. The aim of this study is to assess the correlation between sTKa and patient outcome.
PATIENTS AND METHODS


The Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT) was a double-blind, double-dummy, randomised trial of fulvestrant versus exemestane after progression on non-steroidal aromatase inhibitor therapy, in postmenopausal women with advanced breast cancer. Retrospective analyses of serum archived from EFECT were conducted. sTKa was assessed using the DiviTum® assay on samples collected at baseline, after three and six months of endocrine therapy, and at disease progression.
RESULTS


The median time to progression (mTTP) for patients with low baseline sTKa levels was 5.03 months (95% confidence interval [CI]: 3.91-5.89) versus 2.57 months (95% CI: 2.04-3.52) in patients with high sTKa baseline levels (P < 0.0001). On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045). Similar results were observed in the separate EFECT treatment arms. After adjusting for major prognostic factors, sTKa remained an independent marker.
CONCLUSION


sTKa is a potential circulating prognostic marker in patients with advanced breast cancer treated with endocrine therapy. It may also represent a tool for upfront identification of endocrine therapy resistance and early positive response to therapy. Independent validation of these results is warranted.",2019,"On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045).","['patients with hormone receptor-positive metastatic breast cancer', 'advanced breast cancer', 'postmenopausal women with advanced breast cancer', 'patients with advanced breast cancer treated with endocrine therapy']","['sTKa', 'Faslodex versus Exemestane', 'serum thymidine kinase 1 activity', 'fulvestrant versus exemestane']",['median time to progression (mTTP'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C0701491', 'cui_str': 'Faslodex'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295748', 'cui_str': 'thymidine kinase 1'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0069187', 'cui_str': 'O(4)-methylthymidine triphosphate'}]",,0.26271,"On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045).","[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'McCartney', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Biagioni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Bergqvist', 'Affiliation': 'Biovica International, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mattsson', 'Affiliation': 'Biovica International, Uppsala, Sweden.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Migliaccio', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Benelli', 'Affiliation': 'Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Romagnoli', 'Affiliation': 'Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bonechi', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Boccalini', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pestrin', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galardi', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Luca', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chia', 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Malorni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy. Electronic address: luca.malorni@uslcentro.toscana.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.002']
1090,31543426,"Assessment of microcracks and shear bond strength after debonding orthodontic ceramic brackets on enamel priorly etched by different Er,Cr:YSGG and Er:YAG laser settings without acid application: An in vitro study.","BACKGROUND DATA


Enamel microcrack formation has a high incidence after mechanical debonding of ceramic brackets. This may be due to high delivered shear bond strength values when enamel is priorly etched by phosphoric acid. It is still not well elucidated in the literature if laser etching affects enamel the same way. The aim of the research was to analyze different Er,Cr:YSGG and Er:YAG laser etching settings as an alternative to phosphoric acid, in an attempt to prevent enamel microcrack formation during laser etching and mechanical debonding, while reducing the shear bond strength to the minimal clinical acceptable value.
MATERIALS AND METHODS


One hundred and thirty-three teeth were randomly divided into 7 experimental groups according to their etching modalities. Settings used for enamel etching were in Er,Cr:YSGG groups: Er,Cr:YSGG (1.5Watt, W/20Hertz, Hz); Er,Cr:YSGG (1.5W/15Hz) and Er,Cr:YSGG (2W/20Hz) and settings used for enamel etching in Er:YAG groups were: Er:YAG (60 millijoules, mJ), Er:YAG (80mJ) and Er:YAG (100mJ). Group C etched with 37% phosphoric acid served as control. Microscopic analysis was performed to assess presence of enamel microcracks. Shear bond strength was evaluated after thermocycling using Weibull survival analysis.
RESULTS


All groups showed a reduction in additional microcracks after debonding when compared to control, but only group Er:YAG (60mJ) exhibited a statistically significant difference. Groups Er:YAG (80mJ), control and Er:YAG (100mJ) showed respectively the highest probability of survival at various stress levels followed by groups Er:YAG (60mJ); Er,Cr:YSGG (1.5W/15Hz); Er,Cr:YSGG (2W/20Hz) and Er,Cr:YSGG (1.5W/20Hz) that presented a relatively considerable risk of failure, even at low stress levels.
CONCLUSIONS


When considering reduction of enamel microcrack formation and clinical acceptable shear bond strength, none of the groups succeeded both. Etching by Er:YAG (60mJ) and Er,Cr:YSGG (1.5W/15Hz), showed the least overall microcrack incidence between groups, but Er:YAG (60mJ) displayed significant reduction compared to phosphoric acid. However, etching by Er:YAG (80mJ) had the most predictable results in term of shear bond strength.",2019,"However, etching by Er:YAG (80mJ) had the most predictable results in term of shear bond strength.","['One hundred and thirty-three teeth', 'YSGG groups']","['Er:YAG (60mJ); Er,Cr:YSGG (1.5W/15Hz); Er,Cr:YSGG (2W/20Hz) and Er,Cr:YSGG (1.5W/20Hz', 'enamel etching were in Er,Cr', 'Er,Cr:YSGG (1.5Watt, W/20Hertz, Hz', 'Etching by Er:YAG (60mJ) and Er,Cr:YSGG (1.5W/15Hz', 'Er:YAG (80mJ), control and Er', 'Er,Cr:YSGG (1.5W/15Hz) and Er,Cr:YSGG (2W/20Hz) and settings used for enamel etching in Er', 'phosphoric acid']","['highest probability of survival at various stress levels', 'shear bond strength', 'Shear bond strength', 'additional microcracks']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}]",133.0,0.0330921,"However, etching by Er:YAG (80mJ) had the most predictable results in term of shear bond strength.","[{'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hoteit', 'Affiliation': 'Lebanese University, Faculty of Dental Medicine, Department of Orthodontics, Hadath, Lebanon. Electronic address: marwanhoteit@gmail.com.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Nammour', 'Affiliation': 'University of Liege, Faculty of Medicine, Department of Dental Science, 4020 Liege, Belgium.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Zeinoun', 'Affiliation': 'Lebanese University,Faculty of Dental Medicine, Department of Oral and Maxillofacial Surgery, Lebanon.'}]",International orthodontics,['10.1016/j.ortho.2019.08.019']
1091,31567351,Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy.,"OBJECTIVES


To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting.
DESIGN


Parallel-arm, randomized, double-blinded, placebo-controlled trial.
SETTING


Academic medical center in La Jolla, California.
PATIENTS


Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy.
INTERVENTIONS


Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU.
MEASUREMENTS AND MAIN RESULTS


Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively.
CONCLUSIONS


Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery.",2019,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","['Postoperative Delirium', 'Academic medical center in La Jolla, California', 'Patients Undergoing Elective Pulmonary Thromboendarterectomy', 'Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy', 'One-hundred twenty participants were enrolled and analysis completed in 117', 'patients admitted for elective cardiac surgery']","['placebo', 'Ramelteon 8 mg or matching placebo']","['ICU length of stay', 'postoperative delirium', 'hospital mortality', 'safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale', 'number of delirium-free days', 'Delirium duration', 'Delirium']","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1959997', 'cui_str': 'Pulmonary thromboendarterectomy (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1652106', 'cui_str': 'ramelteon 8 MG [Rozerem]'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",120.0,0.772122,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","[{'ForeName': 'Stuti J', 'Initials': 'SJ', 'LastName': 'Jaiswal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Anuja D', 'Initials': 'AD', 'LastName': 'Vyas', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Heisel', 'Affiliation': 'Division of Hospital Medicine, Scripps Clinic/Scripps Green Hospital, La Jolla, CA.'}, {'ForeName': 'Haritha', 'Initials': 'H', 'LastName': 'Ackula', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Ashna', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Nick H', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Kerr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Madani', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pretorius', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Auger', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Fernandes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}]",Critical care medicine,['10.1097/CCM.0000000000004004']
1092,31096265,The Relationship of Varenicline Agonism of α4β2 Nicotinic Acetylcholine Receptors and Nicotine-Induced Dopamine Release in Nicotine-Dependent Humans.,"INTRODUCTION


Cigarette smoking continues to be one of the most important behavioral causes of morbidity and mortality in the world. Varenicline, an α4β2 nicotinic acetylcholine receptor (nAChR) partial agonist, has been shown to increase smoking quit rates compared with nicotine-based products. This human laboratory, double-blind, placebo-controlled study examined varenicline and placebo effects on α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride non-displaceable binding potential (BPND), and behavioral measures of cigarette smoking, nicotine craving, and withdrawal.
METHODS


Current nicotine dependent daily smokers (N = 17) were randomized to varenicline 1 mg twice daily or placebo for 13 days. Using positron emission tomography), we characterized α4β2-nAChRs occupancy using [18F]AZAN and dopamine receptor binding using [11C]raclopride as well as behavioral measures of cigarettes smoked, craving, and nicotine withdrawal.
RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen, and ventral striatum. Following administration of a controlled-dose nicotine cigarette, dopamine release was significantly suppressed in the ventral striatum in the varenicline-treated compared with the placebo group. There was a significant relationship between α4β2-nAChRs BPND measured in thalamus during the [18F]AZAN scan and nicotine-induced change in raclopride BPND in the ventral striatum.
CONCLUSION


This is the first human study to demonstrate a direct relationship between the extent of varenicline occupancy of α4β2-nAChRs and the magnitude of dopamine release following nicotine use.
IMPLICATIONS


It has remained unclear how nicotinic receptor blockade through partial agonist medications such as varenicline promotes smoking cessation. One hypothesized mechanism is downstream dampening of the mesolimbic reward dopamine system. For the first time in human smokers, we observed a direct relationship between the extent of varenicline blockade of α4β2-nACh nicotinic receptors and the magnitude of dopamine release following smoking. This has mechanistic and therapeutic implications for improving smoking cessation interventions.",2020,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","['Current nicotine dependent, daily smokers (N=17', 'human smokers']","['Varenicline', 'placebo', 'varenicline 1 mg twice daily or placebo', 'varenicline and placebo', 'positron emission tomography (PET']","['18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum', 'α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride binding potential (BPND) and behavioral measures of cigarette smoking, nicotine craving, and withdrawal', 'ventral striatum', 'raclopride BPND', 'smoking quit rates', 'α4β2-nAChRs BPND']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1712046', 'cui_str': 'varenicline 1 MG [Chantix]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0025462', 'cui_str': 'Midbrain'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0872355', 'cui_str': 'Nicotine craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",17.0,0.0570948,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'McCaul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Wand', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Dannals', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz080']
1093,31638341,TheraP: a randomized phase 2 trial of  177  Lu-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603).,"OBJECTIVE


To assess the activity and safety of cabazitaxel chemotherapy vs that of treatment with  177  Lu-PSMA-617, a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel treatment.
PATIENTS AND METHODS


The TheraP trial (ANZUP 1603) is an open-label, randomized, stratified, two-arm multicentre phase 2 trial comparing the activity and safety of cabazitaxel chemotherapy vs  177  Lu-PSMA-617 therapy in the treatment of men with mCRPC. Key eligibility criteria include prior docetaxel chemotherapy, rising prostate-specific antigen (PSA) level, sufficient PSMA avidity, as defined by centrally reviewed  68  Ga-PSMA-11 and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) with no discordant FDG-avid PSMA-negative sites of disease. Patients in the control group receive standard treatment with cabazitaxel (20 mg/m 2  ) i.v. every 3 weeks with prednisolone 10 mg daily orally, for a maximum of 10 cycles. Patients in the experimental group receive  177  Lu-PSMA-617 (8.5 GBq decreasing by 0.5 GBq per cycle) i.v. every 6 weeks, for up to a maximum of six cycles. In the event of an exceptional response as defined on centrally reviewed post-therapy single-photon emission CT imaging, treatment will be suspended but can recommence on progression. The trial aims to include 200 patients who will be centrally randomized to one of the two treatment groups, in a 1:1 ratio. The primary endpoint is PSA response. Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events. The treatment and outcomes of patients excluded on the basis of low PSMA avidity or discordant FDG-avid disease on screening  68  Ga-PSMA-11 and Fluorine-18 ( 18  F)-FDG-PET/CT scan will also be assessed. Enrolment in the study commenced on 29 January 2018.
RESULTS AND CONCLUSIONS


177  Lu-PSMA-617 offers a potential additional life-prolonging treatment option for men with mCRPC. The results of this trial will determine, for the first time in a randomized design, the activity and safety of  177  Lu-PSMA-617, as compared with cabazitaxel chemotherapy in men with progressive mCRPC.",2019,"Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events.","['men with mCRPC', '200 patients who will be centrally randomized to one of the two treatment groups, in a 1:1 ratio', 'progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603', 'men with progressive mCRPC', '29 January 2018', 'men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel treatment', 'patients excluded on the basis of low PSMA avidity or discordant FDG-avid disease on screening  68  Ga-PSMA-11 and Fluorine-18 ( 18']","['prednisolone', 'F)-FDG-PET/CT scan', 'cabazitaxel', 'cabazitaxel chemotherapy vs  177  Lu-PSMA-617 therapy', 'TheraP', 'fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT', 'Lu-PSMA-617 theranostic treatment vs cabazitaxel', 'cabazitaxel chemotherapy']","['activity and safety', 'PSA response', 'overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4078835', 'cui_str': 'PSMA-617'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4046052', 'cui_str': 'Theranostics'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.185373,"Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Emmett', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Violet', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Y Zhang', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Lawrence', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McJannett', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}]",BJU international,['10.1111/bju.14876']
1094,31746775,Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial.,"BACKGROUND


Continuing medical education is important but time-consuming for general practitioners (GPs). Current learning approaches are limited and lack the ability to engage some practitioners. Serious games are new learning approaches that use video games as engaging teaching material. They have significant advantages in terms of efficiency and dissemination.
OBJECTIVE


The aim of this study was to create a serious game and to evaluate it in terms of effectiveness and satisfaction, comparing it with a traditional method of continuing education-article reading.
METHODS


We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent evidence-based medicine journals (reviews from Prescrire and Minerva). We created 51 clinical cases. We then conducted a double-blinded randomized trial comparing the learning provided by a week of access to the game versus source articles. Participants were GPs involved as resident supervisors in 14 French university departments of family practice, recruited by email. Primary outcomes were (1) mean final knowledge score completed 3 to 5 weeks after the end of the intervention and (2) mean difference between knowledge pretest (before intervention) and posttest (3 to 5 weeks after intervention) scores, both scaled on 10 points. Secondary outcomes were transfer of knowledge learned to practice, satisfaction, and time spent playing.
RESULTS


A total of 269 GPs agreed to participate in the study. Characteristics of participants were similar between learning groups. There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21). There was a mean difference score between knowledge pre- and posttests, with significantly superior performance for Hygie (mean gain of 1.6 in the Hygie group and 0.9 in the reading group; P=.02), demonstrating a more efficient and persistent learning with Hygie. The rate of participants that reported to have used the knowledge they learned through the teaching material was significantly superior in the Hygie group: 77% (47/61) in the Hygie group and 53% (25/47) in the reading group; odds ratio 2.9, 95% CI 1.2-7.4. Moreover, 87% of the opinions were favorable, indicating that Hygie is of interest for updating medical knowledge. Qualitative data showed that learners enjoyed Hygie especially for its playful, interactive, and stimulating aspects.
CONCLUSIONS


We conclude that Hygie can diversify the offering for continuing education for GPs in an effective, pleasant, and evidence-based way.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03486275; https://clinicaltrials.gov/ct2/show/NCT03486275.",2019,"There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21).","['Participants were GPs involved as resident supervisors in 14 French university departments of family practice, recruited by email', 'General Practitioners (Hygie']",[],"['transfer of knowledge learned to practice, satisfaction, and time spent playing', 'mean score of the final knowledge test', 'effectiveness and satisfaction', 'mean final knowledge score']","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",269.0,0.291733,"There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21).","[{'ForeName': 'Louis-Baptiste', 'Initials': 'LB', 'LastName': 'Jaunay', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Descartes, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Zerr', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Peguin', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Léandre', 'Initials': 'L', 'LastName': 'Renouard', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Ivanoff', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Service de Recherche Clinique, Fondation Rothschild, Paris, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Griffith', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chassany', 'Affiliation': 'Patient-Reported Outcomes Research, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Duracinsky', 'Affiliation': 'Patient-Reported Outcomes Research, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}]",Journal of medical Internet research,['10.2196/12669']
1095,31092895,"Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m 2  vs. twice-weekly 27 mg/m 2  carfilzomib (randomized A.R.R.O.W. study).","We compared patient-reported outcomes (PROs) with once-weekly carfilzomib 70 mg/m 2  (Kd70 mg/m 2 ) vs. twice-weekly carfilzomib 27 mg/m 2  (Kd27 mg/m 2 ) plus dexamethasone in relapsed or refractory multiple myeloma (RRMM). Patient-reported convenience/satisfaction collected at Cycle 2, Day 1 was compared between groups using logistic regression. European Organization for Research and Treatment of Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires were administered at baseline, then every other cycle. PROs were compared between groups using mixed models for repeated measures. Times from randomization to first deterioration (TTD) in scores were analyzed using Cox regression. PRO analyses included 469 patients. Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 . The mixed models for repeated measures demonstrated no clinically meaningful differences in scores between treatment arms. Clinically meaningful deterioration in QLQ-C30 Global Health Status/QOL rates were 34.2% (once-weekly Kd70 mg/m 2 ) vs. 40.3% (twice-weekly Kd27 mg/m 2 ). TTD was longer for once-weekly Kd70 mg/m 2  vs. twice-weekly Kd27 mg/m 2  for QLQ-C30 fatigue (HR, 0.79; p = 0.035), QLQ-MY20 disease symptoms (HR, 0.67; p = 0.008), EQ-5D-5L index score (HR, 0.58; p = 0.002), and EQ-5D-5L Visual Analog Scale (HR, 0.75, p = 0.031). Once-weekly Kd70 mg/m 2  improved convenience/satisfaction, and reduced HRQOL deterioration vs. twice-weekly Kd27 mg/m 2 , supporting convenient, once-weekly Kd70 mg/m 2  dosing in RRMM.",2019,"Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 .",['469 patients'],['carfilzomib 70 mg/m 2  (Kd70 mg/m 2 ) vs. twice-weekly carfilzomib 27 mg/m 2  (Kd27 mg/m 2 ) plus dexamethasone'],"['QLQ-C30 fatigue', 'QLQ-C30 Global Health Status/QOL rates', 'EQ-5D-5L index score', 'EQ-5D-5L Visual Analog Scale', 'QLQ-MY20 disease symptoms', 'Convenience, satisfaction, health-related quality of life', 'convenience/satisfaction, and reduced HRQOL deterioration', 'Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0626962,"Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 .","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital, Nantes, France. philippe.moreau@chu-nantes.fr.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Boccia', 'Affiliation': 'Center for Cancer and Blood Disorders, Bethesda, MD, USA.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Clinic Heidelberg, Internal Medicine V and National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cocks', 'Affiliation': 'KCStats Consultancy, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trigg', 'Affiliation': 'Adelphi Values Ltd, Manchester, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Zahlten-Kumeli', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yucel', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sumeet S', 'Initials': 'SS', 'LastName': 'Panjabi', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}]",Leukemia,['10.1038/s41375-019-0480-2']
1096,31094789,Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women.,"This pilot study investigated the use of virtual reality (VR) in laboring women. Twenty-seven women were observed for equivalent time during unmedicated contractions in the first stage of labor both with and without VR (order balanced and randomized). Numeric rating scale scores were collected after both study conditions. Significant decreases in sensory pain -1.5 (95% CI, -0.8 to -2.2), affective pain -2.5 (95% CI, -1.6 to -3.3), cognitive pain -3.1 (95% CI, -2.4 to -3.8), and anxiety -1.5 (95% CI, -0.8 to -2.3) were observed during VR. Results suggest that VR is a potentially effective technique for improving pain and anxiety during labor.",2019,Significant decreases in sensory pain -1.5,"['Unmedicated Laboring Women', 'laboring women', 'Labor', 'Twenty-seven women']","['Virtual Reality Analgesia', 'virtual reality (VR', 'Immersive Virtual Reality Analgesia']","['anxiety -1.5', 'sensory pain -1.5', 'cognitive pain -3.1', 'affective pain -2.5', 'pain and anxiety', 'Numeric rating scale scores']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",27.0,0.125889,Significant decreases in sensory pain -1.5,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Frey', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Bauer', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Bell', 'Affiliation': 'Obstetrics and Gynecology, University of Michigan Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa Kane', 'Initials': 'LK', 'LastName': 'Low', 'Affiliation': ""School of Nursing, Women's Studies, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.""}, {'ForeName': 'Afton L', 'Initials': 'AL', 'LastName': 'Hassett', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Cassidy', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Boyer', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Sam R', 'Initials': 'SR', 'LastName': 'Sharar', 'Affiliation': 'Department of Anesthesiology, University of Washington Harborview Medical Center, Seattle, Washington.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003649']
1097,31102457,PDE5 Inhibition Stimulates Tie2-Expressing Monocytes and Angiopoietin-1 Restoring Angiogenic Homeostasis in Diabetes.,"CONTEXT


Vascular dysfunction is a common feature in end-organ complications of type 2 diabetes mellitus (T2DM). The endothelium-specific receptor tyrosine kinase Tie2 and its ligand, angiopoietin-1 (Ang1), participate in the processes of vessel repair, renewal, and maturation. However, their dysregulation in T2DM has seldom been investigated.
OBJECTIVES


To examine the relationship between angiogenic Tie2-expressing monocytes (TEMs) and Ang1, and their pharmacological modulation by the phosphodiesterase type 5 inhibitor (PDE5i) sildenafil, in T2DM and in db/db mouse model.
DESIGN AND SETTING


Randomized, double-blind, placebo-controlled study.
PATIENTS AND INTERVENTION


db/db male mice were randomly assigned to receive 8 weeks of sildenafil or vehicle. Diabetic men were randomly assigned to receive 4 weeks of sildenafil or placebo.
MAIN OUTCOMES AND MEASURES


Peripheral blood cells were investigated by flow cytometry to quantify inflammatory myeloid CD11b+ Gr1+ cells and proangiogenic TEMs in mice and classical CD14++CD16neg monocytes and proangiogenic TEMs in humans at baseline and after treatment. In vitro human tube formation assay was used to test serum angiogenic potential.
RESULTS


We show that TEMs and Ang1 are defective in mouse and human models of diabetes and are normalized by PDE5i treatment. Serum angiogenic properties are impaired in diabetes because they do not support the in vitro formation of capillary-like structures, but they are reestablished by in vivo PDE5i treatment.
CONCLUSIONS


Restoring a more physiological Tie2-Ang1 axis with sildenafil reestablishes serum angiogenic properties in diabetes, promoting angiogenic homeostasis.",2019,We show that TEMs and Ang1 are defective in mouse and human models of diabetes and are normalized by PDE5i treatment.,"['Diabetic men', 'Diabetes', 'male mice']","['sildenafil or vehicle', 'phosphodiesterase type 5 inhibitor (PDE5i) sildenafil', 'placebo', 'TEMs', 'sildenafil', 'sildenafil or placebo']","['Peripheral blood cells', 'inflammatory myeloid CD11b+ Gr1+ cells and proangiogenic TEMs in mice and classical CD14++CD16neg monocytes and proangiogenic TEMs']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0026809', 'cui_str': 'Mice'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}]",,0.0902949,We show that TEMs and Ang1 are defective in mouse and human models of diabetes and are normalized by PDE5i treatment.,"[{'ForeName': 'Mary Anna', 'Initials': 'MA', 'LastName': 'Venneri', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barbagallo', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fiore', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'De Gaetano', 'Affiliation': 'Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Giannetta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Sbardella', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Pozza', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Campolo', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lenzi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02525']
1098,31097514,Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.,"There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance.Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 µg  versus  placebo add-on therapy in patients with symptomatic asthma aged 1-17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment.Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 µg (51%), tiotropium 2.5 µg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 µg) than with placebo, particularly during the seasonal peaks of these AEs.This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.",2019,"Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex.","['paediatric\xa0asthma patients', 'paediatric patients with not fully controlled asthma', 'paediatric patients with symptomatic asthma', '1691 patients treated, 1119 received', 'patients with symptomatic asthma aged 1-17\u2005years']","['Tiotropium', 'tiotropium', 'tiotropium 5 or 2.5\u2005µg  versus  placebo', 'placebo']","['number of AEs related to asthma symptoms and exacerbations', 'adverse events (AEs) and serious AEs (SAEs']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1691.0,0.359001,"Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'Dept of Pediatric Pulmonology and Allergy, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany christian.vogelberg@uniklinikum-dresden.de.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital of Colorado and the University of Colorado Denver School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Elianne J L E', 'Initials': 'EJLE', 'LastName': 'Vrijlandt', 'Affiliation': ""Dept of Pediatric Pulmonology and Pediatric Allergy, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Attilio L', 'Initials': 'AL', 'LastName': 'Boner', 'Affiliation': 'UOC di Pediatria, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno Infantili, Policlinico ""G. Rossi"", Verona, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'El Azzi', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Sebastian Dan', 'Initials': 'SD', 'LastName': 'Vulcu', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Eickmeier', 'Affiliation': ""Dept of Pediatric Allergology, Pulmonology and Cystic Fibrosis, University Children's Hospital, Goethe University, Frankfurt, Germany.""}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel, Bielefeld and Allergy Center of the Ruhr University, Bochum, Germany.'}]",The European respiratory journal,['10.1183/13993003.01824-2018']
1099,31884429,Propofol versus Fentanyl for Sedation in Pediatric Bronchoscopy: A Randomized Controlled Trial.,"OBJECTIVE


To compare propofol and fentanyl to induce conscious sedation in children undergoing flexible bronchoscopy.
STUDY DESIGN


Randomized controlled trial.
SETTING


Pediatric Pulmonology division at a tertiary care center in Delhi, India.
PARTICIPANTS


Children aged 3-15 years who underwent flexible bronchoscopy.
INTERVENTION


Children received either intravenous propofol 1 mg/kg administered as a slow bolus over 1 minute followed by 2 mg/kg/hour infusion, or intravenous Fentanyl 2 µg/kg administered as a slow bolus over one minute.
OUTCOMES


Primary outcome was time to achieve conscious sedation (Ramsay score 3). Secondary outcomes were need for adjuvant midazolam, physician satisfaction, level of cough, recovery features, and side-effects in the groups.
RESULTS


53 children (propofol 27, fentanyl 26) were enrolled in the study. The mean (SD) time taken to achieve Ramsay score 03 was lower in propofol than fentanyl [15.7 (4.4) s vs 206 (55) s, P<0.001]. Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness. There was no difference in drug side-effects between the groups.
CONCLUSIONS


Propofol has a shorter sedation induction time, less coughing during procedure, less recovery time, and better physician satisfaction compared to fentanyl for flexible bronchoscopy in children.",2019,"Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness.","['children undergoing flexible bronchoscopy', 'Pediatric Pulmonology division at a tertiary care center in Delhi, India', '53 children (propofol 27, fentanyl 26) were enrolled in the study', 'Children aged 3-15 years who underwent flexible bronchoscopy', 'Pediatric Bronchoscopy']","['Fentanyl', 'Propofol', 'intravenous propofol', 'propofol and fentanyl']","['recovery time, and better physician satisfaction', 'mean (SD) time taken to achieve Ramsay score 03', 'need for adjuvant midazolam, physician satisfaction, level of cough, recovery features, and side-effects', 'physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness', 'time to achieve conscious sedation (Ramsay score 3', 'drug side-effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C1635023', 'cui_str': 'Pediatric pulmonology'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",53.0,0.1479,"Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness.","[{'ForeName': 'P K G', 'Initials': 'PKG', 'LastName': 'Gunathilaka', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kana Ram', 'Initials': 'KR', 'LastName': 'Jat', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jhuma', 'Initials': 'J', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Prof SK Kabra, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110 029, India, skkabra@hotmail.com.'}]",Indian pediatrics,[]
1100,31098977,Effects of Intensive Primary Care on High-Need Patient Experiences: Survey Findings from a Veterans Affairs Randomized Quality Improvement Trial.,"BACKGROUND


Intensive primary care programs aim to coordinate care for patients with medical, behavioral, and social complexity, but little is known about their impact on patient experience when implemented in a medical home.
OBJECTIVE


Determine how augmenting the VA's medical home (Patient Aligned Care Team, PACT) with a PACT-Intensive Management (PIM) program influences patient experiences with care coordination, access, provider relationships, and satisfaction.
DESIGN


Cross-sectional analysis of patient survey data from a five-site randomized quality improvement study.
PARTICIPANTS


Two thousand five hundred sixty-six Veterans with hospitalization risk scores ≥ 90th percentile and recent acute care.
INTERVENTION


PIM offered patients intensive care coordination, including home visits, accompaniment to specialists, acute care follow-up, and case management from a team staffed by primary care providers, social workers, psychologists, nurses, and/or other support staff.
MAIN MEASURES


Patient-reported experiences with care coordination (e.g., health goal assessment, test and appointment follow-up, Patient Assessment of Chronic Illness Care (PACIC)), access to healthcare services, provider relationships, and satisfaction.
KEY RESULTS


Seven hundred fifty-nine PIM and 768 PACT patients responded to the survey (response rate 60%). Patients randomized to PIM were more likely than those in PACT to report that they were asked about their health goals (AOR = 1.26; P = 0.046) and that they have a VA provider whom they trust (AOR = 1.35; P = 0.005). PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048). However, other effects on coordination, access, and satisfaction did not achieve statistical significance.
CONCLUSIONS


Augmenting VA's patient-centered medical home with intensive primary care had a modestly positive influence on high-risk patients' experiences with care coordination and provider relationships, but did not have a significant impact on most patient-reported access and satisfaction measures.",2019,"PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048).","['Seven hundred fifty-nine PIM and 768 PACT patients', 'Two thousand five hundred sixty-six Veterans with hospitalization risk scores ≥\u200990th percentile and recent acute care']","['Intensive Primary Care', 'PIM offered patients intensive care coordination, including home visits, accompaniment to specialists, acute care follow-up, and case management from a team staffed by primary care providers, social workers, psychologists, nurses, and/or other support staff', 'PACT-Intensive Management (PIM) program']","['mean (SD) PACIC scores', 'experiences with care coordination (e.g., health goal assessment, test and appointment follow-up, Patient Assessment of Chronic Illness Care (PACIC)), access to healthcare services, provider relationships, and satisfaction', 'coordination, access, and satisfaction']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",2566.0,0.0560513,"PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048).","[{'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Zulman', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA. dzulman@stanford.edu.'}, {'ForeName': 'Evelyn T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Stockdale', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Rubenstein', 'Affiliation': 'Department of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Asch', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04965-0']
1101,30239887,Cisplatin Every 3 Weeks Versus Weekly With Definitive Concurrent Radiotherapy for Squamous Cell Carcinoma of the Head and Neck.,"BACKGROUND


Concurrent chemoradiotherapy is an established component of the nonoperative management of locally advanced head and neck squamous cell carcinoma (HNSCC), but the standard dose of 100 mg/m2 cisplatin every 3 weeks is associated with clinically significant toxicity. Interest in a more tolerable regimen has led to the widespread use of weekly lower dose cisplatin, but few randomized trials have compared these approaches.
METHODS


We examined outcomes of patients with stage III-IVb HNSCC treated with definitive intent chemoradiotherapy using either high-dose cisplatin (HDC) or low-dose cisplatin (LDC), using population-based Veterans Affairs data. In an intent-to-treat analysis, patients were assigned to the HDC vs LDC group according to the dose of their first cycle. Variables potentially influencing treatment decisions including cancer site, stage, smoking/alcohol use, and comorbidities were used to generate propensity scores (PS) for the use of HDC. We compared overall survival (OS) by treatment group using Cox regression, adjusting for PS. We then determined the risk of toxicities using PS-adjusted logistic regression.
RESULTS


A total of 2901 patients were included in the analysis; 2200 received HDC (mean initial dose 100 mg/m2). The mean initial dose of LDC was 40 mg/m2. After PS adjustment, HDC was not associated with improved OS over LDC (hazard ratio = 0.94, 95% confidence interval = 0.80 to 1.04). Adjusting for PS, HDC was associated with an increased risk of acute kidney injury, neutropenia, dehydration/electrolyte disturbance, and hearing loss.
CONCLUSION


In this large, population-based study of US military veterans, LDC was associated with similar survival to HDC in the nonoperative definitive management of locally advanced HNSCC of the oral cavity, oropharynx, and hypopharynx/larynx. HDC was associated with statistically significantly more toxicity than LDC. Adoption of LDC may reduce toxicity burden while maintaining OS.",2019,"Adjusting for PS, HDC was associated with an increased risk of acute kidney injury, neutropenia, dehydration/electrolyte disturbance, and hearing loss.
","['Squamous Cell Carcinoma of the Head and Neck', 'A total of 2901 patients were included in the analysis; 2200 received', 'patients with stage III-IVb HNSCC treated with', 'locally advanced head and neck squamous cell carcinoma (HNSCC']","['definitive intent chemoradiotherapy using either high-dose cisplatin (HDC) or low-dose cisplatin (LDC', 'cisplatin', 'HDC', 'LDC', 'Definitive Concurrent Radiotherapy', 'chemoradiotherapy', 'Cisplatin', 'HDC vs LDC']","['risk of acute kidney injury, neutropenia, dehydration/electrolyte disturbance, and hearing loss', 'toxicity', 'overall survival (OS', 'cancer site, stage, smoking/alcohol use, and comorbidities', 'mean initial dose of LDC']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517651', 'cui_str': 'Two thousand two hundred'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1704431', 'cui_str': 'Disorder of electrolytes (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",2901.0,0.213817,"Adjusting for PS, HDC was associated with an increased risk of acute kidney injury, neutropenia, dehydration/electrolyte disturbance, and hearing loss.
","[{'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Bauml', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Michael J. Crescenz VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vinnakota', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}, {'ForeName': 'Yeun-Hee', 'Initials': 'YH', 'LastName': 'Anna Park', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Bates', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fojo', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sewanti', 'Initials': 'S', 'LastName': 'Limaye', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Damjanov', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Michael J. Crescenz VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Di Stefano', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Michael J. Crescenz VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ciunci', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Genden', 'Affiliation': 'Department of Otolaryngology, The Mount Sinai School of Medicine, New York, NY.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wisnivesky', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, The Mount Sinai School of Medicine, New York, NY.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Ferrandino', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, The Mount Sinai School of Medicine, New York, NY.'}, {'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Sigel', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, James J. Peters VA Medical Center, Bronx, NY.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djy133']
1102,31740092,Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.,"OBJECTIVES


Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic.
MATERIALS & METHODS


This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients.
RESULTS


Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
CONCLUSION


Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.",2019,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","['patients with severe renal colic referring to the emergency department', 'Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men', 'severe renal colic pain management', 'patients with severe renal colic', 'patients referred to the emergency department']","['Fentanyl', 'Atomized intranasal vs intravenous fentanyl', 'fentanyl combination with ketorolac', 'IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl', 'intravenous (IVF) and intranasal (INF) fentanyl administration']","['efficacy of pain management', 'mean pain severity', 'baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI', 'Numerical Rating Scale (NRS', 'severity of pain', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0222045'}]",220.0,0.0731758,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Nazemian', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Torabi', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: me_torabi@kmu.ac.ir.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158483']
1103,31092546,Characteristics and treatment strategies for severe tricuspid regurgitation.,"OBJECTIVE


This study aimed to identify characteristics, spectrum of tricuspid regurgitation (TR) severity and treatment patterns in patients considered for intervention of severe TR at a tertiary centre. The population being considered for TR intervention is currently not well defined and the role of transcatheter interventions is unclear.
METHODS


The study involved 87 patients with severe TR considered for intervention from 1 March 2016 to 12 November 2018 at Mayo Clinic. Patients receiving medications alone were compared with those receiving intervention to identify patterns in demographics, clinical/echocardiographic associations and survival.
RESULTS


Mean age was 80±9 (56% female), 93% had atrial fibrillation and 64% had chronic kidney disease ≥3 a. Follow-up was 331±276 days; 95% were symptomatic with 6 min walk distance of 270±110 m. Loop diuretics were used in 93%; aldosterone antagonists in 35%. Mean tricuspid annular plane systolic excursion was 15.6±3.8 mm, effective regurgitant orifice area (EROA) 82±32 mm 2  and stroke volume index 39±11 mL/m 2 ; 48% had at least moderate right ventricular (RV) dysfunction, and 75% did not undergo intervention. Patients receiving intervention showed trends towards larger EROA (93±33 vs 75±31 mm 2 ), better right ventricular function and more severe symptoms. Overall group 30-day and 1-year survival were 100% and 76%, respectively.
CONCLUSIONS


Patients with severe TR considered for intervention are commonly elderly with atrial fibrillation, advanced TR and RV dysfunction; 75% were treated with medications alone and not offered intervention. Patients with greater EROA, better RV function and more severe symptoms were more likely to receive intervention. These findings have implications for future trial design.",2019,"Patients receiving intervention showed trends towards larger EROA (93±33 vs 75±31 mm 2 ), better right ventricular function and more severe symptoms.","['87 patients with severe TR considered for intervention from 1 March 2016 to 12 November 2018 at Mayo Clinic', 'severe tricuspid regurgitation', 'Mean age was 80±9 (56% female), 93% had atrial fibrillation and 64% had chronic kidney disease ≥3\u2009a. Follow-up was 331±276 days; 95% were symptomatic with 6 min walk distance of 270±110\u2009m. Loop diuretics were used in 93', 'patients considered for intervention of severe TR at a tertiary centre']",['aldosterone antagonists'],"['right ventricular function and more severe symptoms', 'mm 2  and stroke volume index 39±11', 'Overall group 30-day and 1-year survival', 'larger EROA', 'effective regurgitant orifice area (EROA) 82±32', 'RV function and more severe symptoms', 'Mean tricuspid annular plane systolic excursion', 'moderate right ventricular (RV) dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid Regurgitation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}]","[{'cui': 'C0080311', 'cui_str': 'Ventricular Function, Right'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}]",87.0,0.0745295,"Patients receiving intervention showed trends towards larger EROA (93±33 vs 75±31 mm 2 ), better right ventricular function and more severe symptoms.","[{'ForeName': 'Brenden S', 'Initials': 'BS', 'LastName': 'Ingraham', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Sorin V', 'Initials': 'SV', 'LastName': 'Pislaru', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Vuyisile T', 'Initials': 'VT', 'LastName': 'Nkomo', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Rick A', 'Initials': 'RA', 'LastName': 'Nishimura', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Dearani', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Charanjit S', 'Initials': 'CS', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Mackram F', 'Initials': 'MF', 'LastName': 'Eleid', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-314741']
1104,31740476,Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial.,"INTRODUCTION


Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with persistent insomnia. However, research on online sleep interventions targeting episodic insomnia has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from episodic insomnia to persistent insomnia.
METHODS AND ANALYSIS


This is a pragmatic two-arm multicentre, randomised controlled trial comparing eCBTI with treatment as usual (TAU) in outpatients. Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited. Patients will be randomly assigned to receive 1 week eCBTI via a Smartphone application, or to receive TAU. Treatment effects will be assessed at 1 week and 3 months after intervention. The primary outcome of the study, whether the eCBTI program is sufficient in preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index. Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale. Additionally, the Hospital Anxiety and Depression Scale and the Short-Form 12-Item Health Survey will be used for measurement of mood symptoms and quality of life.
ETHICS AND DISSEMINATION


Ethical approval for the study has been obtained from the Ethics Committee of Southern Medical University (reference number: NFEC-2017-131). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary.
TRIAL REGISTRATION


NCT03302455 (clinicaltrials.gov). Date of registration: October 5, 2017.",2019,"Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale.","['Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited', 'patients with persistent insomnia', 'outpatients']","['e-aid cognitive behavioural therapy', 'brief e-aid cognitive behavioural therapy', 'online self-guided sleep intervention', 'eCBTI', '1\u2009week eCBTI via a Smartphone application, or to receive TAU']","['Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale', 'preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index', 'Hospital Anxiety and Depression Scale', 'mood symptoms and quality of life']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",200.0,0.159507,"Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Dhirendra', 'Initials': 'D', 'LastName': 'Paudel', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shirley Xin', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China zhang73bin@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-033457']
1105,31094806,Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial.,"BACKGROUND


An intravenous (IV) formulation of meloxicam was developed for moderate-to-severe pain management. This study evaluated the safety and efficacy of meloxicam IV after open abdominal hysterectomy. Meloxicam IV is an investigational product not yet approved by the US Food and Drug Administration.
METHODS


Women (N = 486) with moderate-to-severe pain after open abdominal hysterectomy were enrolled in this multicenter, randomized, double-blind, placebo- and active-controlled trial. Subjects were randomized to receive a single dose of meloxicam IV (5-60 mg), placebo, or morphine (0.15 mg/kg) in ≤6 hours after morphine dosing on postoperative day 1 and were evaluated for 24 hours. Rescue morphine (≈0.15 mg/kg IV) was available if needed for pain not relieved by the study medication. In an open-label extension (N = 295), meloxicam IV was administered once daily for the remaining hospital stay (or per the investigator's discretion). The coprimary efficacy end points were the summed pain intensity difference (SPID24) and total pain relief (TOTPAR24) from hour 0 to 24 hours after dosing. Effect size, the standardized difference between means reported in standard deviation (SD) units, was calculated to indicate the magnitude of the difference in the mean analgesic effect measured for different intervention groups.
RESULTS


Subjects who received morphine or meloxicam IV had a median time to first perceptible pain relief within 6-8 minutes. Morphine and meloxicam IV 5-60 mg produced statistically significant differences than placebo in SPID24 and TOTPAR24. SPID24 (standard error [SE]) for meloxicam IV 5-60 mg ranged from -56276.8 (3926.46) to -33517.1 (3930.1; P < .001); SPID24 (SE) for morphine and placebo were -29615.8 (3869.2; P < .001) and 4555.9 (3807.1), respectively. SPID24 effect sizes (95% confidence intervals) for the 60, 30, 15, 7.5, and 5 mg meloxicam IV doses and morphine were 1.93 (1.61-2.25), 2.00 (1.65-2.35), 1.70 (1.35-2.05), 1.28 (0.95-1.60), 1.25 (0.90-1.61), and 1.12 (0.77-1.45) SDs, respectively. TOTPAR24 (SE) for meloxicam IV 5-60 mg ranged from 3104.5 (155.28) to 4130.4 (191.17; P < .001); TOTPAR24 (SE) for morphine and placebo were 2723.3 (188.4; P < .001) and 1100.6 (185.4), respectively. TOTPAR24 effect sizes (95% confidence interval) for the 60, 30, 15, 7.5, and 5 mg meloxicam IV doses and morphine were 2.03 (1.70-2.35), 2.05 (1.70-2.40), 1.78 (1.43-2.13), 1.35 (1.03-1.67), 1.37 (1.01-1.72), and 1.10 (0.75-1.45) SDs, respectively. The mean total opioid consumed (SD) during the double-blind phase was 4.6 (8.17), 5.3 (8.85), 5.9 (7.85), 8.5 (9.67), 9.3 (9.47), 9.6 (8.12), and 16.0 (10.15) mg for patients in the 60, 30, 15, 7.5, and 5 mg meloxicam IV, morphine, and placebo groups, respectively. Generally, meloxicam IV was well tolerated, evidenced by the incidence of adverse events compared to placebo and lack of deaths and treatment-related serious adverse events.
CONCLUSIONS


A meloxicam IV dose of 5-60 mg was generally well tolerated and appeared to reduce opioid consumption in subjects with moderate-to-severe pain after open abdominal hysterectomy. Once-daily administration of meloxicam IV produced analgesic effect within 6-8 minutes postdose that was maintained over a 24-hour dosing interval.",2019,A meloxicam IV dose of 5-60 mg was generally well tolerated and appeared to reduce opioid consumption in subjects with moderate-to-severe pain after open abdominal hysterectomy.,"['After Open Abdominal Hysterectomy', 'subjects with moderate-to-severe pain after open abdominal hysterectomy', 'Women (N = 486) with moderate-to-severe pain after open abdominal hysterectomy', 'Subjects With Moderate-to-Severe Pain']","['morphine or meloxicam IV', 'placebo, or morphine', 'Morphine and meloxicam IV', 'placebo', 'meloxicam IV', 'Intravenous Meloxicam', 'morphine', 'meloxicam IV, morphine', 'Rescue morphine', 'meloxicam', 'Meloxicam IV', 'SPID24', 'morphine and placebo']","['safety and efficacy', 'opioid consumption', 'mean analgesic effect', 'summed pain intensity difference (SPID24) and total pain relief (TOTPAR24', 'TOTPAR24 (SE', 'TOTPAR24 effect sizes', 'Analgesic Efficacy and Safety', 'analgesic effect', 'median time to first perceptible pain relief', 'standard deviation (SD) units', 'incidence of adverse events', 'mean total opioid consumed (SD']","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",486.0,0.285618,A meloxicam IV dose of 5-60 mg was generally well tolerated and appeared to reduce opioid consumption in subjects with moderate-to-severe pain after open abdominal hysterectomy.,"[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'From the Department of Gynecology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Mack', 'Affiliation': 'Recro Pharma, Inc, Malvern, Pennsylvania.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'McCallum', 'Affiliation': 'Recro Pharma, Inc, Malvern, Pennsylvania.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Clinical Statistics Consulting, Blue Bell, Pennsylvania.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freyer', 'Affiliation': 'Recro Pharma, Inc, Malvern, Pennsylvania.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003920']
1106,31753903,Rationale and design of the Lowlands Saves Lives trial: a randomised trial to compare CPR quality and long-term attitude towards CPR performance between face-to-face and virtual reality training with the Lifesaver VR app.,"INTRODUCTION


Layperson cardiopulmonary resuscitation (CPR) is a key aspect in the chain of survival after cardiac arrest. New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
METHODS AND ANALYSIS


The Lowlands Saves Lives trial is a prospective randomised open-blinded end-point evaluation study, comparing two 20 min CPR training protocols: standardised, certified instructor-led face-to-face training complying with current education guidelines (using Laerdal Little Anne manikins), and VR training, using the UK Resuscitation Council endorsed Lifesaver VR app. In the latter, chest compressions are practiced on a pillow.During VR training, participants learn to resuscitate by completing a filmed CPR scenario while wearing VR goggles and headphones. Eligible for inclusion are adult attendees of Lowlands Science, a specific section of the 3-day Lowlands music festival (50 000 attendees), dedicated exclusively to science. Following the training, all participants will perform a CPR test on a Laerdal Resusci Anne QCPR manikin. Primary outcome measures are depth and rate of chest compressions, measured using CPR manikins. The key secondary outcome is overall CPR performance, with real-time examination (blinded for study group) of all items of a European Resuscitation Council endorsed checklist, and evaluation of a sample of videotaped CPR tests by a blinded event committee.Given the unique setting of a festival, the primary additional analysis will address the impact of alcohol levels on CPR quality parameters and overall performance. Follow-up questionnaires will evaluate the attitude towards performing CPR. This unique study may provide important insights into innovative CPR training methods, factors that impact CPR performance and the impact on long-term attitude towards resuscitation.
ETHICS AND DISSEMINATION


This study received approval from the research ethics committee of the Radboudumc. All participants will provide written informed consent. The results of this study will be published in peer-reviewed journals and presented at (inter)national conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT04013633).",2019,"New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
","['Eligible for inclusion are adult attendees of Lowlands Science, a specific section of the 3-day Lowlands music festival (50 000 attendees), dedicated exclusively to science']","['Layperson cardiopulmonary resuscitation (CPR', 'certified instructor-led face-to-face training complying with current education guidelines (using Laerdal Little Anne manikins), and VR training']","['depth and rate of chest compressions, measured using CPR manikins', 'CPR quality parameters and overall performance', 'overall CPR performance, with real-time examination (blinded for study group) of all items of a European Resuscitation Council endorsed checklist, and evaluation of a sample of videotaped CPR tests']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015922', 'cui_str': 'Festivals'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.119092,"New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
","[{'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands j.nas@radboudumc.nl.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Bonnes', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-033648']
1107,30905405,Learning new gait patterns is enhanced by specificity of training rather than progression of task difficulty.,"The use of motor learning strategies may enhance rehabilitation outcomes of individuals with neurological injuries (e.g., stroke or cerebral palsy). A common strategy to facilitate learning of challenging tasks is to use sequential progression - i.e., initially reduce task difficulty and slowly increase task difficulty until the desired difficulty level is reached. However, the evidence related to the use of such sequential progressions to improve learning is mixed for functional skill learning tasks, especially considering situations where practice duration is limited. Here, we studied the benefits of sequential progression using a functional motor learning task that has been previously used in gait rehabilitation. Three groups of participants (N = 43) learned a novel motor task during treadmill walking using different learning strategies. Participants in the specific group (n = 21) practiced only the criterion task (i.e., matching a target template that was scaled-up by 30%) throughout the training. Participants in the sequential group (n = 11) gradually progressed to the criterion task (from 3% to 30% in increments of 3%), whereas participants in the random group (n = 11) started at 3% and progressed in random increments (involving both increases and decreases in task difficulty) to the criterion task. At the end of training, kinematic tracking performance on the criterion task was evaluated in all participants both with and without visual feedback. Results indicated that the tracking error was significantly lower in the specific group, and no differences were observed between the sequential and the random progression groups. The findings indicate that the amount of practice in the criterion task is more critical than the difficulty and variations of task practice when learning new gait patterns during treadmill walking.",2019,"Results indicated that the tracking error was significantly lower in the specific group, and no differences were observed between the sequential and the random progression groups.","['individuals with neurological injuries (e.g., stroke or cerebral palsy']","['motor learning strategies', 'novel motor task during treadmill walking using different learning strategies']",['tracking error'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",[],,0.0160867,"Results indicated that the tracking error was significantly lower in the specific group, and no differences were observed between the sequential and the random progression groups.","[{'ForeName': 'Chandramouli', 'Initials': 'C', 'LastName': 'Krishnan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA; Biomedical Engineering, University of Michigan, Ann Arbor, MI, USA; Michigan Robotics Institute, University of Michigan, Ann Arbor, MI, USA; School of Kinesiology, University of Michigan, Ann Arbor, MI, USA. Electronic address: mouli@umich.edu.'}, {'ForeName': 'Aastha K', 'Initials': 'AK', 'LastName': 'Dharia', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Augenstein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA; Mechanical Engineering, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Washabaugh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA; Biomedical Engineering, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'Reid', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Brown', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.03.014']
1108,31525168,Protein Supplementation Does Not Augment Adaptations to Endurance Exercise Training.,"INTRODUCTION


Recently, it has been speculated that protein supplementation may further augment the adaptations to chronic endurance exercise training. We assessed the effect of protein supplementation during chronic endurance exercise training on whole-body oxidative capacity (V˙O2max) and endurance exercise performance.
METHODS


In this double-blind, randomized, parallel placebo-controlled trial, 60 recreationally active males (age, 27 ± 6 yr; body mass index, 23.8 ± 2.6 kg·m; V˙O2max, 47 ± 6 mL·min·kg) were subjected to 12 wk of triweekly endurance exercise training. After each session and each night before sleep, participants ingested either a protein supplement (PRO; 28.7 g casein protein) or an isoenergetic carbohydrate placebo (PLA). Before and after the 12 wk of training, V˙O2max and endurance exercise performance (~10-km time trial) were assessed on a cycle ergometer. Muscular endurance (total workload achieved during 30 reciprocal isokinetic contractions) was assessed by isokinetic dynamometry and body composition by dual-energy x-ray absorptiometry. Mixed-model ANOVA was applied to assess whether training adaptations differed between groups.
RESULTS


Endurance exercise training induced an 11% ± 6% increase in V˙O2max (time effect, P < 0.0001), with no differences between groups (PRO, 48 ± 6 to 53 ± 7 mL·min·kg; PLA, 46 ± 5 to 51 ± 6 mL·min·kg; time-treatment interaction, P = 0.50). Time to complete the time trial was reduced by 14% ± 7% (time effect, P < 0.0001), with no differences between groups (time-treatment interaction, P = 0.15). Muscular endurance increased by 6% ± 7% (time effect, P < 0.0001), with no differences between groups (time-treatment interaction, P = 0.84). Leg lean mass showed an increase after training (P < 0.0001), which tended to be greater in PRO compared with PLA (0.5 ± 0.7 vs 0.2 ± 0.6 kg, respectively; time-treatment interaction, P = 0.073).
CONCLUSION


Protein supplementation after exercise and before sleep does not further augment the gains in whole-body oxidative capacity and endurance exercise performance after chronic endurance exercise training in recreationally active, healthy young males.",2019,"Time to complete the time trial was reduced by 14% ± 7% (time effect, P < 0.0001), with no differences between groups (time-treatment interaction, P = 0.15).","['healthy young males', '60 recreationally active males (age, 27 ± 6 yr; body mass index, 23.8 ± 2.6 kg·m; V˙O2max, 47 ± 6 mL·min·kg']","['chronic endurance exercise training', 'triweekly endurance exercise training', 'isoenergetic carbohydrate placebo (PLA', 'Protein supplementation', 'placebo', 'protein supplement (PRO', 'protein supplementation', 'Endurance exercise training', 'Protein Supplementation']","['isokinetic dynamometry and body composition', 'whole-body oxidative capacity (V˙O2max) and endurance exercise performance', 'Muscular endurance', 'Leg lean mass', 'V˙O2max and endurance exercise performance', 'Muscular endurance (total workload achieved during 30 reciprocal isokinetic contractions', 'V˙O2max']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0585333', 'cui_str': 'Triweekly (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}]",,0.147681,"Time to complete the time trial was reduced by 14% ± 7% (time effect, P < 0.0001), with no differences between groups (time-treatment interaction, P = 0.15).","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Jonvik', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Kevin J M', 'Initials': 'KJM', 'LastName': 'Paulussen', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Shiannah L', 'Initials': 'SL', 'LastName': 'Danen', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Ingrid J M', 'Initials': 'IJM', 'LastName': 'Ceelen', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Astrid M', 'Initials': 'AM', 'LastName': 'Horstman', 'Affiliation': 'FrieslandCampina, Amersfoort, THE NETHERLANDS.'}, {'ForeName': 'Floris C', 'Initials': 'FC', 'LastName': 'Wardenaar', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'VAN Dijk', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, THE NETHERLANDS.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002028']
1109,31554937,Long-term phase 3 study of esaxerenone as mono or combination therapy with other antihypertensive drugs in patients with essential hypertension.,"This study investigated the long-term antihypertensive effects of esaxerenone, a novel nonsteroidal mineralocorticoid receptor blocker, alone or in combination with a calcium channel blocker (CCB) or a renin-angiotensin system (RAS) inhibitor, in Japanese patients with essential hypertension. Patients were treated with esaxerenone starting at 2.5 mg/day increasing to 5 mg/day if required to achieve blood pressure (BP) targets as a monotherapy or with a CCB or RAS inhibitor. After the first 12 weeks of treatment, an additional antihypertensive agent could be added if required to achieve the target BP; the total treatment period was 28 or 52 weeks. The primary endpoint was a change from baseline in sitting BP. Of the 368 enrolled patients, 245 received monotherapy, and 59 and 64, respectively, took a CCB or RAS inhibitor concurrently. Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1 (-17.3, -14.9)/-7.7 (-8.4, -6.9), -18.9 (-20.2, -17.7)/-9.9 (-10.7, -9.2), and -23.1 (-25.0, -21.1)/-12.5 (-13.6, -11.3) mmHg, respectively (all P < 0.0001 vs baseline). Similar BP reductions at these weeks were observed between all patient subgroups stratified by age, and the observed decreases in 24-h ambulatory BP were consistent with the efficacy observed in sitting BP. Esaxerenone was also well-tolerated with a rate of hyperkalemia at 5.4% (serum potassium ≥5.5 mEq/L), indicating a good safety profile for treatment over the long-term or in combination with a CCB or RAS inhibitor. In conclusion, esaxerenone may be a promising treatment option for patients with hypertension.",2019,"Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1","['patients with hypertension', 'patients with essential hypertension', 'Japanese patients with essential hypertension', '368 enrolled patients, 245 received monotherapy, and 59 and 64, respectively, took a CCB or RAS inhibitor concurrently']","['Esaxerenone', 'CCB or RAS inhibitor', 'esaxerenone', 'esaxerenone as mono or combination therapy', 'calcium channel blocker (CCB) or a renin-angiotensin system (RAS) inhibitor']","['Similar BP reductions', '24-h ambulatory BP', 'change from baseline in sitting BP', 'rate of hyperkalemia', 'sitting systolic/diastolic BP', 'blood pressure (BP) targets']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0035096'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",368.0,0.0406456,"Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1","[{'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. rakugi@geriat.med.osaka-u.ac.jp.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba, Sendai, Miyagi, 980-8575, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University, School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0314-7']
1110,30968615,"Effects of Dapagliflozin on Endothelial Function, Renal Injury Markers, and Glycemic Control in Drug-Naïve Patients with Type 2 Diabetes Mellitus.","BACKGROUND


The study aimed to evaluate the effects of dapagliflozin and metformin on vascular endothelial function and renal injury markers.
METHODS


This prospective, randomized, open-label, crossover study included drug-naïve patients with type 2 diabetes mellitus, who were randomized to receive 8 weeks of initial treatment using metformin or dapagliflozin and crossed over for another 8 weeks of treatment after a 1-week washout period. Systemic endothelial function was evaluated via the reactive hyperemic index (RHI).
RESULTS


The 22 participants included 10 males (45.5%) and had a median age of 58 years. The RHI values were not significantly changed during both 8-week treatment periods and there was no significant difference between the treatments. Relative to the metformin group, 8 weeks of dapagliflozin treatment produced significantly higher median  N -acetyl-beta-D-glucosaminidase levels (10.0 ng/mL [interquartile range (IQR), 6.8 to 12.1 ng/mL] vs. 5.6 ng/mL [IQR, 3.8 to 8.0 ng/mL],  P =0.013). Only the dapagliflozin group exhibited improved homeostatic model assessment of insulin resistance and body weight, while serum ketone and β-hydroxybutyrate levels increased.
CONCLUSION


Dapagliflozin treatment did not affect systemic endothelial function or renal injury markers except  N -acetyl-beta-D-glucosaminidase.",2019,The RHI values were not significantly changed during both 8-week treatment periods and there was no significant difference between the treatments.,"['22 participants included 10 males (45.5%) and had a median age of 58 years', 'drug-naïve patients with type 2 diabetes mellitus', 'Drug-Naïve Patients with Type 2 Diabetes Mellitus']","['metformin', 'metformin or dapagliflozin', 'Dapagliflozin', 'dapagliflozin and metformin', 'dapagliflozin']","['vascular endothelial function and renal injury markers', 'reactive hyperemic index (RHI', 'homeostatic model assessment of insulin resistance and body weight, while serum ketone and β-hydroxybutyrate levels', 'systemic endothelial function or renal injury markers', 'median  N -acetyl-beta-D-glucosaminidase levels', 'Endothelial Function, Renal Injury Markers, and Glycemic Control', 'Systemic endothelial function', 'RHI values']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-D-glucosaminidase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.0408777,The RHI values were not significantly changed during both 8-week treatment periods and there was no significant difference between the treatments.,"[{'ForeName': 'Sung Hye', 'Initials': 'SH', 'LastName': 'Kong', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bo Kyung', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Kyong', 'Initials': 'MK', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}]",Diabetes & metabolism journal,['10.4093/dmj.2018.0208']
1111,31081404,Comparison of endometrial receptivity of clomiphene citrate versus letrozole in women with polycystic ovary syndrome: a randomized controlled study.,"The aim of the study was to compare the effect of clomiphene citrate (CC) and letrozole on endometrial receptivity for ovulation induction in women with polycystic ovary syndrome (PCOS). A randomized controlled study included 160 patients diagnosed with PCOS, out of which 80 patients received 50 mg of CC and 80 patients received 2.5 mg of letrozole for successful ovulation induction. Endometrial thickness and pattern, the blood flow of uterine artery and subendometrial region, endometrial volume and vascularization index were measured. The ratio of multilayered endometrial pattern in letrozole group was significantly increased on the day of human chorionic gonadotropin (hCG) administration compared with CC group (77.5% vs. 55.0%). The volume, vascularization index (VI), flow index (FI), and vascularization flow index (VFI) of endometrium on the day of hCG administration and 7-9 days after ovulation in letrozole group were significantly increased. The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively). Letrozole increased pregnancy rates by improving endometrial receptivity compared with CC in patients with PCOS.",2019,"The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively).","['patients with PCOS', 'women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', '160 patients diagnosed with PCOS, out of which 80 patients received']","['human chorionic gonadotropin (hCG', 'Letrozole', 'clomiphene citrate versus letrozole', 'clomiphene citrate (CC) and letrozole', '50\u2009mg of CC', 'letrozole']","['volume, vascularization index (VI), flow index (FI), and vascularization flow index (VFI) of endometrium on the day of hCG administration and 7-9\u2009days after ovulation', 'Endometrial thickness and pattern, the blood flow of uterine artery and subendometrial region, endometrial volume and vascularization index', 'endometrial receptivity', 'biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate', 'ratio of multilayered endometrial pattern', 'pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",160.0,0.0973621,"The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': ""The 521 Hospital of Ordnance Industry, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shulan', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1612358']
1112,31081067,Correlation between MMP-2 gene polymorphism and cataract susceptibility.,"OBJECTIVE


To investigate the correlation between matrix metalloproteinase-2 (MMP-2) gene polymorphism and cataract.
PATIENTS AND METHODS


104 cataract patients and 100 healthy subjects were enrolled and assigned to the observation group and control group, respectively. General clinical data of the enrolled subjects were collected. The inflammatory factors were detected, and the rs243865 polymorphism of MMP-2 gene was detected using the TaqMan-MGB probe.
RESULTS


The levels of interleukin-6 (IL-6), IL-1β, C-reactive protein (CRP), and tumor necrosis factor-1α (TNF-1α) in the observation group were higher than those in the control group (p<0.05). There were significant differences in the genotype and allele distribution frequency between the two groups (p<0.05). In the genetic model analysis, the additive model was remarkably different between the two groups (p<0.05). However, the recessive model and dominant model were not different between the two groups (p>0.05).
CONCLUSIONS


Cataract is correlated with inflammatory factors, and the rs243865 polymorphism of MMP-2 gene has a correlation with the incidence of cataract.",2019,"In the genetic model analysis, the additive model was remarkably different between the two groups (p<0.05).",['104 cataract patients and 100 healthy subjects'],[],"['genotype and allele distribution frequency', 'levels of interleukin-6 (IL-6), IL-1β, C-reactive protein (CRP), and tumor necrosis factor-1α']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",104.0,0.0245193,"In the genetic model analysis, the additive model was remarkably different between the two groups (p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Ophthalmology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China. 13606320866@163.com.'}, {'ForeName': 'G-Y', 'Initials': 'GY', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'R-L', 'Initials': 'RL', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201904_17674']
1113,31690616,Ultrasound Assessment of Diaphragmatic Motion in Subjects With ARDS During Transpulmonary Pressure-Guided PEEP Titration.,"BACKGROUND


We aimed to investigate the effects of incremental PEEP titration in patients with ARDS on regional diaphragmatic motion with bedside ultrasound.
METHODS


Dorsal diaphragmatic excursion (DDE) and ventral diaphragmatic excursion (VDE) were measured using anatomic M-mode ultrasonography of the right hemidiaphragm as PEEP was randomized to -6, -3, +3, and +6 cm H 2 O from baseline to achieve a positive transpulmonary pressure. Inter-operator variability of DDE was assessed in 10 separate subjects.
RESULTS


A total of 14 subjects ventilated for ARDS were enrolled. Subjects had a mean age of 54 ± 12 y, mean P aO 2  /F IO 2  = 137 ± 54 mm Hg, and mean sequential organ failure assessment (SOFA) score = 14 ± 1). Transpulmonary pressure, DDE, and DDE/VDE ratio increased with incremental PEEP titration (-1.15 cm H 2 O vs 3.63 cm H 2 O,  P  < .001; 4.9 mm vs 8.2 mm,  P  < .001; and 62% vs 93%,  P  < .001, respectively). When transpulmonary pressure became positive, a visual increase in DDE and DDE/VDE ratio 0.60 to 0.93 was observed (from 0.48 cm to 0.82 cm, R 2  = 0.87,  P  = .02; and R 2  = 0.93,  P  = .006, respectively). There was high agreement in DDE measurements between 2 ultrasonographers (intra-class correlation 0.987,  P  < .001).
CONCLUSIONS


DDE was affected by incremental PEEP titration toward a positive transpulmonary pressure. The ultrasound assessment using anatomic M-mode allowed for specific measurement of regional diaphragmatic excursion. This pattern of motion in the dependent regions of the diaphragm during PEEP titration in subjects with ARDS achieving a positive transpulmonary pressure may reflect a potential target for future studies in the bedside assessment for lung recruitment. (Clinical Trials.gov registration NCT02463773.).",2020,"When transpulmonary pressure became positive, a visual increase in DDE and DDE/VDE ratio 0.60 to 0.93 was observed (from 0.48 cm to 0.82 cm,  R   2  = 0.87,  P  = .02; and  R   2  = 0.93,  P  = .006, respectively).","['10 separate subjects', 'Subjects With ARDS', 'patients with ARDS on regional diaphragmatic motion with bedside ultrasound', 'Subjects had a mean age of 54 ± 12 y, mean  P   aO 2  / F   IO 2  = 137 ± 54 mm Hg, and mean sequential organ failure assessment (SOFA) score = 14 ± 1', '14 subjects ventilated for ARDS were enrolled']",['incremental PEEP titration'],"['Transpulmonary pressure, DDE, and DDE/VDE ratio', 'Dorsal diaphragmatic excursion (DDE) and ventral diaphragmatic excursion (VDE', 'DDE measurements', 'visual increase in DDE and DDE/VDE ratio']","[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0011038', 'cui_str': 'Dichlorodiphenyl Dichloroethylene'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion (observable entity)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.326946,"When transpulmonary pressure became positive, a visual increase in DDE and DDE/VDE ratio 0.60 to 0.93 was observed (from 0.48 cm to 0.82 cm,  R   2  = 0.87,  P  = .02; and  R   2  = 0.93,  P  = .006, respectively).","[{'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Cho', 'Affiliation': 'Department of Pulmonary and Critical Care, University of Minnesota, Minneapolis. choxx548@umn.edu.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Hennepin County Medical Center, Pulmonary and Critical Care, Minneapolis, Minnesota.'}, {'ForeName': 'Sum', 'Initials': 'S', 'LastName': 'Ambur', 'Affiliation': 'Hennepin County Medical Center, Pulmonary and Critical Care, Minneapolis, Minnesota.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lunos', 'Affiliation': 'Clinical and Translational Science Institute, University of Minnesota, Minneapolis.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shapiro', 'Affiliation': 'Hennepin County Medical Center, Pulmonary and Critical Care, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Hennepin County Medical Center, Pulmonary and Critical Care, Minneapolis, Minnesota.'}]",Respiratory care,['10.4187/respcare.06643']
1114,31084640,Reduction in the occurrence of distressing involuntary memories following propranolol or hydrocortisone in healthy women.,"BACKGROUND


Pharmacological treatments targeting the neuroendocrine stress response may hold special promise in secondary prevention of posttraumatic stress disorder (PTSD). However, findings from clinical trials have been inconsistent and the efficacy of specific drugs, their temporal window of efficacy, effective doses and the characteristics of likely treatment responders remain unclear.
METHOD


Using an experimental human model of distressing involuntary memory formation, we compare the effects of two drugs that have theoretical or empirical support as secondary preventive agents in PTSD. Eighty-eight healthy women (average age: 23.5 years) received oral propranolol (80 mg), hydrocortisone (30 mg), or matched placebo immediately after viewing a 'trauma film'. They then completed daily, time-stamped intrusion diaries for 1 week, at the end of which, voluntary memory was tested.
RESULTS


While neither drug affected voluntary memory for the trauma narrative, propranolol treatment was associated with 42% fewer, and hydrocortisone with 55% fewer intrusions across the week, relative to placebo. Additionally, propranolol reduced general trauma-like symptoms, and post-drug cortisol levels were negatively correlated with intrusion frequency in the hydrocortisone group.
CONCLUSIONS


Overall, this study shows substantial reductions in intrusive memories and preserved voluntary narrative-declarative memory following either propranolol or hydrocortisone in an experimental model of psychological trauma. As such, despite some inconsistencies in clinical trials, our findings support continued investigation of propranolol and hydrocortisone as secondary preventive agents for re-experiencing symptoms of PTSD. The findings also suggest that it is critical for future research to identify the conditions governing the preventive efficacy of these drugs in PTSD.",2020,"RESULTS


While neither drug affected voluntary memory for the trauma narrative","['Eighty-eight healthy women (average age: 23.5 years', 'healthy women']","['propranolol or hydrocortisone', 'propranolol and hydrocortisone', 'oral propranolol', 'propranolol', 'hydrocortisone', 'hydrocortisone (30 mg), or matched placebo']","['general trauma-like symptoms, and post-drug cortisol levels', 'distressing involuntary memories', 'intrusive memories and preserved voluntary narrative-declarative memory']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}]",88.0,0.0430301,"RESULTS


While neither drug affected voluntary memory for the trauma narrative","[{'ForeName': 'Sunjeev K', 'Initials': 'SK', 'LastName': 'Kamboj', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'An Tong', 'Initials': 'AT', 'LastName': 'Gong', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'ZhiHui', 'Initials': 'Z', 'LastName': 'Sim', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Adrihani A', 'Initials': 'AA', 'LastName': 'Rashid', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Baba', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Iskandar', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, UCLH, London, UK.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}]",Psychological medicine,['10.1017/S0033291719001028']
1115,31082538,Five-year outcomes in cardiac surgery patients with atrial fibrillation undergoing concomitant surgical ablation versus no ablation. The long-term follow-up of the PRAGUE-12 Study.,"BACKGROUND


The long-term effect of concomitant surgical ablation (SA) on clinical outcomes in an unselected population of patients has not been sufficiently reported in randomized studies.
OBJECTIVE


The aim of this study was to assess clinical outcomes of the SA after 5 years of follow-up.
METHODS


The PRAGUE-12 study was a prospective, randomized clinical trial assessing cardiac surgery with ablation for AF vs cardiac surgery alone. Patients with AF who were also indicated for cardiac surgery (coronary artery disease [CAD], valve surgery) were randomized to SA or control (no ablation) group. All patients were followed for 5 years. The primary endpoint was a composite of cardiovascular death, stroke, hospitalization for heart failure, or severe bleeding. Secondary endpoint was a recurrence of AF.
RESULTS


A total of 207 patients were analyzed (SA group = 108 patients, control group = 99 patients). Both groups were similar relative to important clinical characteristics except for CAD, which was more common in the control group. Cumulative incidence curves showed a higher incidence of the primary endpoint in the control group (P = .024, Gray's test). However, after adjusting for all covariables, the difference between groups was not significant (subhazard ratio [SHR] 0.69 [0.47-1.02], P = .068). The incidence of stroke and AF recurrences were significantly reduced in the SA group, and remained significant even after adjustment for all covariables, including CAD (stroke: SHR 0.32 [0.12-0.84], P = .02, AF recurrences: SHR 0.44 [0.31-0.62], P < .001).
CONCLUSIONS


Concomitant SA of AF is associated with a greater likelihood of maintaining sinus rhythm and a decreased risk of stroke.",2019,"Cumulative incidence curves showed a higher incidence of the primary endpoint in the control group (P = .024, Gray's test).","['207 patients were analyzed (SA group = 108 patients, control group = 99 patients', 'Patients with AF who were also indicated for cardiac surgery (coronary artery disease [CAD], valve surgery', 'cardiac surgery patients with atrial fibrillation undergoing']","['concomitant surgical ablation versus no ablation', 'SA or control (no ablation', 'cardiac surgery with ablation for AF vs cardiac surgery alone', 'concomitant surgical ablation (SA']","['recurrence of AF', 'incidence of stroke and AF recurrences', 'risk of stroke', 'composite of cardiovascular death, stroke, hospitalization for heart failure, or severe bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",207.0,0.1048,"Cumulative incidence curves showed a higher incidence of the primary endpoint in the control group (P = .024, Gray's test).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Osmancik', 'Affiliation': 'Cardiocenter, III(rd) Internal - Cardiology Clinic, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Budera', 'Affiliation': 'Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Talavera', 'Affiliation': 'Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hlavicka', 'Affiliation': 'Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Herman', 'Affiliation': 'Cardiocenter, III(rd) Internal - Cardiology Clinic, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Holy', 'Affiliation': 'Department of Cardiology, Masaryk Hospital in Usti nad Labem, Krajska Zdravotni and UJEP in Usti na Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Cervinka', 'Affiliation': 'Department of Cardiology, Masaryk Hospital in Usti nad Labem, Krajska Zdravotni and UJEP in Usti na Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Smid', 'Affiliation': 'Cardiology Department, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hanak', 'Affiliation': 'Department of Arrhythmias and Cardiac Pacing, National Institute for Cardiovascular Disease, Bratislava, Slovakia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hatala', 'Affiliation': 'Department of Arrhythmias and Cardiac Pacing, National Institute for Cardiovascular Disease, Bratislava, Slovakia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Cardiocenter, III(rd) Internal - Cardiology Clinic, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}]",Heart rhythm,['10.1016/j.hrthm.2019.05.001']
1116,31027873,A ketogenic drink improves brain energy and some measures of cognition in mild cognitive impairment.,"INTRODUCTION


Unlike for glucose, uptake of the brain's main alternative fuel, ketones, remains normal in mild cognitive impairment (MCI). Ketogenic medium chain triglycerides (kMCTs) could improve cognition in MCI by providing the brain with more fuel.
METHODS


Fifty-two subjects with MCI were blindly randomized to 30 g/day of kMCT or matching placebo. Brain ketone and glucose metabolism (quantified by positron emission tomography; primary outcome) and cognitive performance (secondary outcome) were assessed at baseline and 6 months later.
RESULTS


Brain ketone metabolism increased by 230% for subjects on the kMCT (P < .001) whereas brain glucose uptake remained unchanged. Measures of episodic memory, language, executive function, and processing speed improved on the kMCT versus baseline. Increased brain ketone uptake was positively related to several cognitive measures. Seventy-five percent of participants completed the intervention.
DISCUSSION


A dose of 30 g/day of kMCT taken for 6 months bypasses a significant part of the brain glucose deficit and improves several cognitive outcomes in MCI.",2019,"RESULTS


Brain ketone metabolism increased by 230% for subjects on the kMCT (P < .001) whereas brain glucose uptake remained unchanged.","['Fifty-two subjects with MCI', 'mild cognitive impairment']","['kMCT or matching placebo', 'kMCT', 'Ketogenic medium chain triglycerides (kMCTs']","['several cognitive outcomes', 'episodic memory, language, executive function, and processing speed improved on the kMCT', 'brain energy', 'brain glucose deficit', 'Brain ketone metabolism', 'brain glucose uptake', 'Increased brain ketone uptake', 'Brain ketone and glucose metabolism']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",52.0,0.0652835,"RESULTS


Brain ketone metabolism increased by 230% for subjects on the kMCT (P < .001) whereas brain glucose uptake remained unchanged.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Fortier', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada. Electronic address: melanie.fortier2@usherbrooke.ca.""}, {'ForeName': 'Christian-Alexandre', 'Initials': 'CA', 'LastName': 'Castellano', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Croteau', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Pharmacology and Physiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Langlois', 'Affiliation': ""CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bocti', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'St-Pierre', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Vandenberghe', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Bernier', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Pharmacology and Physiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Pharmacology and Physiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Department of Computer Science, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Descoteaux', 'Affiliation': 'Department of Computer Science, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whittingstall', 'Affiliation': ""Department of Radiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada; CR-CHUS, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lepage', 'Affiliation': ""CR-CHUS, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Sherbrooke Molecular Imaging Center, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Department of Nuclear Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada; Department of Radiobiology, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Éric E', 'Initials': 'ÉE', 'LastName': 'Turcotte', 'Affiliation': ""CR-CHUS, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Sherbrooke Molecular Imaging Center, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Department of Nuclear Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada; Department of Radiobiology, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Fulop', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Cunnane', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada; Department of Pharmacology and Physiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2018.12.017']
1117,31407394,Tildrakizumab efficacy and impact on quality of life up to 52 weeks in patients with moderate-to-severe psoriasis: a pooled analysis of two randomized controlled trials.,"BACKGROUND


Two randomized controlled trials (reSURFACE 1 and 2) have demonstrated the effectiveness of tildrakizumab, a high-affinity, humanized, IgG1κ, anti-interleukin-23 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in the first 28 weeks.
OBJECTIVES


To examine the efficacy of tildrakizumab and its impact on quality of life (QoL) in patients with different levels of week-28 Psoriasis Area and Severity Index (PASI) improvement.
METHODS


Patients treated with tildrakizumab 100 mg or 200 mg from baseline to week 28 were pooled from reSURFACE 1 and reSURFACE 2 and classified into five mutually exclusive week-28 PASI improvement groups for each dose: PASI 0-49, 50-74, 75-89, 90-99 and 100. Mean PASI improvement and Dermatology Life Quality Index (DLQI) 0/1 over time were examined for each group.
RESULTS


Of 1156 patients, 575 were in the 100-mg and 578 in the 200-mg cohorts, respectively. At week 28, 8.3%, 14.3%, 23.8%, 30.4% and 23.1% in the 100-mg and 4.0%, 18.1%, 19.6%, 29.1% and 29.3% in the 200-mg cohort achieved PASI < 50, 50-74, 75-89, 90-99 and 100, respectively. Patients with PASI < 50 at week 28 could be identified as early as week 8, and those with week-28 PASI ≥ 90 had approximately 50% PASI improvement by week 4. Among patients achieving PASI > 50 at week 28 who continued the same dose of tildrakizumab to week 52, mean PASI improvement was maintained or improved over time. Similar results were observed for both doses. Higher proportions of patients achieved DLQI 0/1 in higher week-28 PASI groups, and DLQI 0/1 was maintained or improved to week 52. However, not all patients with PASI 100 had DLQI 0/1.
CONCLUSION


Patients unlikely to respond to tildrakizumab could be identified by week 8, and those likely to achieve a PASI ≥ 90 response could be identified as early as week 4. Week-28 PASI improvement level correlated with QoL improvement.",2019,"Mean PASI improvement and Dermatology Life Quality Index (DLQI) 0/1 over time were examined for each group.
","['Patients treated with', 'Patients with Moderate-to-Severe Psoriasis', 'Of 1,156 patients, 575 were in the 100-mg and 578 in the 200-mg cohorts, respectively', 'patients with different levels of week-28 Psoriasis Area and Severity Index (PASI) improvement']","['tildrakizumab 100 mg or 200 mg from baseline', 'tildrakizumab']","['quality of life (QoL', 'mean PASI improvement', 'Quality of Life', 'Mean PASI improvement and Dermatology Life Quality Index (DLQI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",1156.0,0.050996,"Mean PASI improvement and Dermatology Life Quality Index (DLQI) 0/1 over time were examined for each group.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sofen', 'Affiliation': 'Department of Medicine (Dermatology), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lowry', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.15862']
1118,29909704,"The effects of intravenous dextrose 5%, Ringer's solution, and oral intake on the duration of labor stages in nulliparous women: a double-blind, randomized, controlled trial.","Background and objectives:  Childbirth consists of a three-stage period beginning with uterine contractions and ending in the expulsion of the placenta. The present study was conducted to compare the effects of Ringer's solution, dextrose solution 5%, and oral intake on the duration of total labor and labor stages (primary outcome) and the frequency of oxytocin administration and prolonged labor (secondary outcome) in nulliparous women with spontaneous vaginal delivery. Materials and methods:  The present randomized clinical trial was conducted on 201 nulliparous women in labor assigned with a randomized block design to three groups, each receiving either Ringer's solution plus oral fluids, dextrose solution 5% solution plus oral fluids or oral fluids alone. The solutions were intravenously administered at a rate of 125 ml/h in the groups receiving the solutions and the subjects in the oral fluids group could consume liquids of their choice (water, orange juice, and apple juice). The duration of total labor and labor stages (the active stage, the second, and third stages of labor) were recorded by the researcher in minutes. Furthermore, the frequency of oxytocin administration and prolonged labor were recorded by the researcher by using a checklist. Data were analyzed using the Kruskal-Wallis test, Mann-Whitney's  U -test, chi- square test and Fisher exact test. Results:  The mean (±SD) duration of total labor was 301.2 (±50.0) minutes in the Ringer group, 171.9 (±36.4) in the dextrose 5% group, and 524.8 (±103.4) in the oral fluids group, suggesting a statistically significant intergroup difference ( p  < .001). The mean (±SD) duration of the active stage of labor was 276.7 (±91.3) minutes in the Ringer group, 150.6 (±78.5) in the dextrose 5% group, and 302.4 (±136.8) in the oral fluids group, suggesting a statistically significant intergroup difference ( p  < .001). A significant difference was also observed between the three groups in terms of the duration of the third stage of labor ( p  < .001); however, no significant differences were observed in terms of the duration of the second stage of labor ( p  = .058). Furthermore, a significant difference was observed between the three groups in terms of the need for oxytocin administration ( p  ≤ .001) and the frequency of prolonged labor ( p  = .001). Conclusion:  The results suggest that the consumption of dextrose solution by nulliparous women reduces the duration of labor, the need for oxytocin administration and the frequency of prolonged labor compared to when Ringer's solution and oral fluids are used.",2020,"Furthermore, a significant difference was observed between the three groups in terms of the need for oxytocin administration (p ≤ .001) and the frequency of prolonged labor (p = .001).
","['nulliparous women', 'nulliparous women with spontaneous vaginal delivery', '201 nulliparous women in labor assigned']","['oxytocin administration and prolonged labor', ""intravenous dextrose 5%, Ringer's solution, and oral intake"", 'dextrose solution', ""Ringer's solution, dextrose solution"", ""Ringer's solution plus oral fluids, dextrose solution 5% solution plus oral fluids or oral fluids alone"", 'oxytocin']","['duration of total labor and labor stages', 'duration of total labor and labor stages (the active stage, the second, and third stages of labor', 'duration of the third stage of labor', 'frequency of prolonged labor', 'frequency of oxytocin administration and prolonged labor', 'mean (±SD) duration of total labor', 'mean (±SD) duration of the active stage of labor', 'duration of the second stage of labor', 'duration of labor, the need for oxytocin administration and the frequency of prolonged labor']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384485', 'cui_str': 'Delivery normal (finding)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor (disorder)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0073386', 'cui_str': ""Ringer's Solution""}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0022873', 'cui_str': 'Third Stage Labor'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor (disorder)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",201.0,0.186763,"Furthermore, a significant difference was observed between the three groups in terms of the need for oxytocin administration (p ≤ .001) and the frequency of prolonged labor (p = .001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ahadi Yulghunlu', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Sehhatie Shafaie', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Mohaddesi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1489792']
1119,29886787,Foley's catheter balloon for induction of mid-trimester missed abortion with or without traction applied: a randomized controlled trial.,"Objective:  To determine whether the traction placed on a transcervical Foley catheter balloon inserted for the induction of mid-trimester missed abortion results in faster time of abortion. Study design:  It was randomized clinical trial conducted at Assiut Woman's Health Hospital, Egypt, from September 2016 to August 2017 on women with missed abortion in the mid-trimester. Participants were randomly assigned to transcervical Foley catheter balloon insertion with or without traction. The primary outcome of this study was insertion to abortion time. The secondary outcomes included insertion to catheter expulsion time, vaginal bleeding, and pain associated with insertion. The outcome variables were analyzed using Mann-Whitney U and chi-square tests. A logistic regression model was utilized to examine the association between patient's characteristics and the failure of Foley catheter balloon expulsion within 24 hours. Results:  Two hundred women were recruited (100 women in each group). The insertion to abortion time was significantly shorter in group I (traction group) than group II (no traction group) (16.49 ± 2.59 versus 18.24 ± 3.30 hours;  p  = .000). Insertion to balloon expulsion time in group I was also significantly short (7.92 ± 0.86 versus 9.12 ± 1.19 hours;  p  = .000). However, a significantly higher rate of vaginal bleeding and a higher degree of pain were reported by the women in group I ( p  = .008,  p  = .000; respectively). The nulliparity, longer interpregnancy interval (>22 months), smaller gestational age (<14 weeks) and lower Bishop Score before insertion (<2) were significantly associated with a higher likelihood of Foley catheter balloon expulsion failure within 24 hours. Conclusion:  The small time advantage of traction does not compensate for the downsides of traction, mainly pain, analgesic use, and vaginal bleeding.",2020,The insertion to abortion time was significantly shorter in group I (traction group) than group II (no traction group) (16.49 ± 2.59 versus 18.24 ± 3.30 hours; p = .000).,"[""Assiut Woman's Health Hospital, Egypt, from September 2016 to August 2017 on women with missed abortion in the mid-trimester"", 'Two hundred women were recruited (100 women in each group']","['transcervical Foley catheter balloon', 'transcervical Foley catheter balloon insertion with or without traction', ""Foley's catheter balloon""]","['insertion to abortion time', 'pain, analgesic use, and vaginal bleeding', 'pain', 'rate of vaginal bleeding', 'smaller gestational age', 'nulliparity, longer interpregnancy interval', 'Foley catheter balloon expulsion failure', 'insertion to catheter expulsion time, vaginal bleeding, and pain associated with insertion']","[{'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000814', 'cui_str': 'Silent miscarriage'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0179804'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0179804'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]",200.0,0.165887,The insertion to abortion time was significantly shorter in group I (traction group) than group II (no traction group) (16.49 ± 2.59 versus 18.24 ± 3.30 hours; p = .000).,"[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.""}, {'ForeName': 'Heba A', 'Initials': 'HA', 'LastName': 'Botros', 'Affiliation': 'Department of Obstetrics & Gynecology, El Eman Hospital for Woman and Child, Assiut, Egypt.'}, {'ForeName': 'Sayed A', 'Initials': 'SA', 'LastName': 'Mostafa', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1487949']
1120,30033781,The utility of amniotic fluid pH and electrolytes for prediction of neonatal respiratory disorders.,"Background:  Amniotic fluid (AF) is a complex structure with a changing content by gestation. Lower genomic expression of Na channels in airways was shown to be associated with respiratory distress syndrome (RDS). The aim of this study was to determine the possible role of amniotic fluid pH and electrolytes for prediction of neonatal respiratory morbidities. Methods:  This was a prospective controlled cohort study. During C-section, 1 ml of AF was aspirated before incision of membranes. AF pH and electrolytes were analyzed by blood gas analyzer. Maternal and neonatal demographic features and clinical outcomes, respiratory morbidities were all recorded. Results:  AF Na and K values were significantly higher in all infants with respiratory morbidities compared with those who did not develop respiratory findings. AF Na value was significantly higher in preterm neonates with RDS as well as in term neonates with transient tachypnea of the newborn (TTN). AF pH did not show any significant difference for prediction of respiratory morbidities in term and preterm infants. Conclusion:  This is the first study that reported the value of AF Na and K levels for prediction of respiratory morbidities in term and preterm infants. However, further studies including larger number of infants are required to confirm the role of AF analysis to predict neonatal respiratory morbidities. Randomized controlled trial (RCT) number: NCT02813954.",2020,AF Na value was significantly higher in preterm neonates with RDS as well as in term neonates with transient tachypnea of the newborn (TTN).,"['neonatal respiratory disorders', 'term and preterm infants']",['amniotic fluid pH and electrolytes'],"['AF pH and electrolytes', 'AF Na value', 'Maternal and neonatal demographic features and clinical outcomes, respiratory morbidities', 'AF Na and K values', 'respiratory morbidities']","[{'cui': 'C1285373', 'cui_str': 'Neonatal respiratory system disorder'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0002638', 'cui_str': 'Amniotic Fluid'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}]","[{'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",,0.156727,AF Na value was significantly higher in preterm neonates with RDS as well as in term neonates with transient tachypnea of the newborn (TTN).,"[{'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Yılmaz Semerci', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Yücel', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, Turkey.'}, {'ForeName': 'Ibrahim Mert', 'Initials': 'IM', 'LastName': 'Erbas', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, Turkey.'}, {'ForeName': 'Osman Samet', 'Initials': 'OS', 'LastName': 'Gunkaya', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Talmac', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, Turkey.'}, {'ForeName': 'Merih', 'Initials': 'M', 'LastName': 'Çetinkaya', 'Affiliation': 'Department of Pediatrics, Division of Neonatalogy, Faculty of Medicine, Uludag University, Bursa, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1488961']
1121,31734761,Split-face comparison of the picosecond 1064-nm Nd:YAG laser using a microlens array and the quasi-long-pulsed 1064-nm Nd:YAG laser for treatment of photoaging facial wrinkles and pores in Asians.,"Skin photoaging manifests deeper wrinkles and larger pore size. Various lasers have been tried for rejuvenation of photoaging skin, and the quasi-long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet (Nd:YAG) laser is one promising treatment option. New types of laser device are emerging, including devices operating with picosecond pulse duration combined with a microlens array, which are regarded as a new breakthrough for skin rejuvenation. We aimed to evaluate the clinical effectiveness and safety of the picosecond 1064-nm Nd:YAG laser using a microlens array compared with the quasi-long-pulsed 1064-nm Nd:YAG laser in a split-face design. We designed a split-faced, prospective study and enrolled 25 subjects with photoaging facial wrinkles and enlarged pores. Each facial area was randomly assigned to undergo treatment with either the picosecond 1064-nm Nd:YAG laser (Pico-arm) or the quasi-long-pulsed 1064-nm Nd:YAG laser (Quasi-arm). We performed five laser sessions at 2-week intervals, and final results were assessed after 20 weeks after the initial laser session. We used a five-point global assessment scale, wrinkle and pore index derived from 3D camera analysis. We enrolled a total of 25 subjects (24 females and 1 male) with Fitzpatrick skin types III to IV and a mean age of 63.8 ± 5.7 years. After treatment, 54.2% of subjects in the Pico-arm reported at least moderate improvement in visible pores compared with 41.7% of the Quasi-arm (P = 0.001). A total of 12.5% of subjects in the Pico-arm showed moderate improvement in wrinkles versus 4.2% of the Quasi-arm (P = 0.125). There was a 41.3% reduction in the pore index in the Pico-arm compared to a 3.9% increase in the Quasi-arm (P = 0.048). There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01). Pain assessment score was higher in the Pico-arm than the Quasi-arm (3.65 ± 1.70 vs 1.28 ± 1.28, P = 0.001). No serious adverse events occurred during the study. Our findings suggest that the picosecond 1064-nm Nd:YAG laser with a microlens array is as effective as the quasi-long-pulsed 1064-nm Nd:YAG laser for treatment of photoaging wrinkles and pores.",2020,There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01).,"['enrolled 25 subjects with photoaging facial wrinkles and enlarged pores', 'photoaging facial wrinkles and pores in Asians', '25 subjects (24 females and 1 male) with Fitzpatrick skin types III to IV and a mean age of 63.8 ± 5.7 years']","['Nd:YAG laser (Pico-arm) or the quasi-long-pulsed 1064-nm', 'neodymium:yttrium-aluminum-garnet', 'YAG laser', 'picosecond 1064-nm Nd:YAG laser using a microlens array compared with the quasi-long-pulsed 1064-nm Nd:YAG laser', 'picosecond 1064-nm Nd:YAG laser using a microlens array and the quasi-long-pulsed 1064-nm', 'Nd:YAG laser', 'Nd:YAG']","['visible pores', 'Pain assessment score', 'moderate improvement in wrinkles', 'pore index', 'wrinkle index', 'serious adverse events']","[{'cui': 'C0263415', 'cui_str': 'Solar degeneration (disorder)'}, {'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}]","[{'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",25.0,0.0200192,There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01).,"[{'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Yim', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Serk', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea. susini@naver.com.'}]",Lasers in medical science,['10.1007/s10103-019-02906-1']
1122,31734798,Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial.,"PURPOSE


Suboptimal adherence to tyrosine kinase inhibitors (TKIs) contributes to poor clinical outcomes in chronic myeloid leukemia (CML). This randomised controlled trial (RCT) aimed to evaluate the impact of a medication management service (MMS) on adherence to TKIs and clinical outcomes.
METHODS


A parallel RCT was conducted in two hospitals in Malaysia, where 129 CML patients were randomised to MMS or control (usual care) groups using a stratified 1:1 block randomisation method. The 6-month MMS included three face-to-face medication use reviews, CML and TKI-related education, two follow-up telephone conversations, a printed information booklet and two adherence aids. Medication adherence (primary outcome), molecular responses and health-related quality of life (HRQoL) scores were assessed at baseline, 6th and 12th month. Medication adherence and HRQoL were assessed using medication possession ratio and the European Organisation for Research and Treatment in Cancer questionnaire (EORTC_QLQ30_CML24) respectively.
RESULTS


The MMS group (n = 65) showed significantly higher adherence to TKIs than the control group (n = 64) at 6th month (81.5% vs 56.3%; p = 0.002), but not at 12th month (72.6% vs 60.3%; p = 0.147). In addition, a significantly higher proportion of participants in the MMS group achieved major molecular response at 6th month (58.5% vs 35.9%; p = 0.010), but not at 12th month (66.2% vs 51.6%; p = 0.092). Significant deep molecular response was also obtained at 12th month (24.6% vs 10.9%; p = 0.042). Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
CONCLUSIONS


The MMS improved CML patients' adherence to TKI as well as achieved better clinical outcomes.
TRIAL REGISTRATION


Clinicaltrial.gov (ID: NCT03090477).",2020,"Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
","['two hospitals in Malaysia, where 129 CML patients', 'patients with chronic myeloid leukaemia', 'chronic myeloid leukemia (CML']","['medication management service (MMS', 'MMS or control (usual care', 'tyrosine kinase inhibitors (TKIs', 'medication management service']","['Significant deep molecular response', 'adherence to TKIs', 'Medication adherence and HRQoL', 'Medication adherence (primary outcome), molecular responses and health-related quality of life (HRQoL) scores', 'major molecular response']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",129.0,0.118383,"Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
","[{'ForeName': 'Bee Kim', 'Initials': 'BK', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, 47500, Subang Jaya, Selangor, Malaysia.""}, {'ForeName': 'Li-Chia', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'Kian Meng', 'Initials': 'KM', 'LastName': 'Chang', 'Affiliation': 'Department of Hematology, Ampang Hospital, 68000, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Sharmini', 'Initials': 'S', 'LastName': 'Balashanker', 'Affiliation': 'School of Pharmacy, University of Nottingham Malaysia Campus, 43500, Semenyih, Selangor, Malaysia.'}, {'ForeName': 'Ping Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia. pcbee@um.edu.my.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05133-0']
1123,31734931,"Impact of different modes of school dental health education on oral health-related knowledge, attitude and practice behaviour: an interventional study.","PURPOSE


The study was planned to evaluate the effectiveness of three modes of school dental health education (SDHE) on the oral health-related knowledge, attitude and practice (KAP) behaviour of school children.
METHODS


An interventional study was carried out among 8-9 year old school children from January 2016 to January 2018. Three hundred and sixty children from three schools in Tiruchengode, Tamil Nadu, India participated in this study. Each school was randomly allotted with a mode (drama, modified snake and ladder game, flashcard) of SDHE, which was delivered for 20 min, every 6 months for 2 years. A validated questionnaire with 18 questions was used to record oral health-related KAP behaviour at baseline and after 2 years.
RESULTS


At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes. The mean difference in the cumulative knowledge score between baseline and 2 years was 1.39 ± 2.05 for drama mode, 1.8 ± 1.51 for game mode and 1.7 ± 1.5 for flashcard mode of SDHE. There was a significant difference in three knowledge questions and one attitude practice behaviour question between the three groups at the end of 2 years.
CONCLUSIONS


All the three modes were effective in improving the oral health-related KAP behaviour of school children. Game mode made a better impact on the knowledge scores of these children, and it was observed to be more child-friendly and entertaining.",2020,"At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes.","['school children', '8-9\xa0year old school children from January 2016 to January 2018', 'Three hundred and sixty children from three schools in Tiruchengode, Tamil Nadu, India participated in this study']","['school dental health education', 'school dental health education (SDHE']","['oral health-related knowledge, attitude and practice behaviour', 'knowledge questions and one attitude practice behaviour question', 'cumulative knowledge score', 'percentage of correct response']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018703', 'cui_str': 'Health Education, Dental'}]","[{'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",360.0,0.0152297,"At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes.","[{'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'GeethaPriya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India. drgppedo@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Asokan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kandaswamy', 'Affiliation': 'Faculty of Dental Sciences, Sri Ramachandra University, Porur, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shyam', 'Affiliation': 'Department of Public Health Dentistry, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-019-00489-7']
1124,31734088,A contra-lateral comparison of the visual effects of a photochromic vs. non-photochromic contact lens.,"PURPOSE


To compare the effects of a photochromic contact lens vs. a non-photochromic control lens on visual function.
METHODS


A subject-masked, prospective contralateral eye design was used. Sixty-one subjects were enroled based on age (using a 2:1 allocation ratio for ages 18-39 and 40-65 years, respectively). The study lenses were senofilcon A with photochromic additive (Test) that filtered over the entire lens, compared to a non-photochromic Control with no tint. The Test lens was partially activated during testing with a steady-state transmittance of approximately 62%. Eligible subjects were tested using both study lenses, with Test and Control lens randomized by eye. Five visual function outcomes were tested: photostress recovery (PSR), glare disability (GD), glare discomfort (GDC), chromatic contrast (CC) and vernier acuity (VA). Iris colour and macular pigment density were assessed as control variables. PSR was measured as the time needed to recover sight of a target after an intense xenon flash exposure; GD was evaluated as the energy needed to veil a central target by a surrounding xenon annulus; GDC was measured using bio-imaging of the squint response and by self-report using a 9-item Likert scale; CC was measured as thresholds for a yellow grating target superposed on a 460-nm background; VA was determined by measuring vernier offsets of light lines through apertures.
RESULTS


Based on our stimulus conditions, PSR was 43% faster using the Test vs. the Control. The eye wearing the Test had 38% less squint (GDC) compared to the Control. GD was improved by 36% in the Test vs. Control and CC was enhanced by 48% with the Test. There was no significant difference in VA.
CONCLUSIONS


There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens. This benefit was seen specifically with respect to PRT, GDC, GD and CC thresholds.",2020,There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens.,"['Eligible subjects', 'Sixty-one subjects were enroled based on age (using a 2:1 allocation ratio for ages 18-39 and 40-65 years, respectively']","['photochromic vs. non-photochromic contact lens', 'photochromic contact lens vs. a non-photochromic control lens']","['PSR', 'GD', 'Iris colour and macular pigment density', 'visual function', 'VA', 'photostress recovery (PSR), glare disability (GD), glare discomfort (GDC), chromatic contrast (CC) and vernier acuity (VA']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1321306', 'cui_str': 'Glare disability'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0392714', 'cui_str': 'Vernier acuity (observable entity)'}]",61.0,0.0328088,There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Renzi-Hammond', 'Affiliation': 'Human Biofactors Laboratory, Institute of Gerontology, Department of Health Promotion and Behavior, University of Georgia, Athens, GA 30602, United States. Electronic address: lrenzi@uga.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Buch', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: Jbuch@its.jnj.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cannon', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: jcannon@its.jnj.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hacker', 'Affiliation': 'Georgia Center for Sight, Greensboro, GA 30642, United States. Electronic address: hackerlauren@gmail.com.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Toubouti', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: Ytoubouti@its.jnj.com.'}, {'ForeName': 'Billy R', 'Initials': 'BR', 'LastName': 'Hammond', 'Affiliation': 'Vision Sciences Laboratory, Behavioral and Brain Sciences Program, Department of Psychology, University of Georgia, Athens, GA, 30602, Greece. Electronic address: bhammond@uga.edu.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.10.138']
1125,31772064,Oxygen Therapy Delivery and Body Position Effects Measured With Electrical Impedance Tomography.,"BACKGROUND


The aim of this prospective randomized crossover study was to compare the short-term effects of high-flow nasal cannula (HFNC) therapy and a 45° head-up tilt to the short-term effects of conventional oxygen (O 2 ) therapy in post-abdominal surgery patients.
METHODS


A total of 18 subjects who were successfully weaned from ventilator support after abdominal surgery were included in the study. The subjects were randomly assigned to 2 groups: conventional O 2  was applied in group A for 15 min, and HFNC (60 L/min) was applied in group B for 15 min. A 15-min washout period with conventional O 2  was performed before the interventions were switched in both groups. Heart rate, blood pressure, breathing frequency, ratio of arterial partial pressure of oxygen to the fraction of inspired oxygen (P aO 2  /F IO 2  ), and subject-reported comfort scores were recorded. Changes in end-expiratory lung impedance (EELI) were calculated with electrical impedance tomography.
RESULTS


Results are presented as the percent change in lung volume compared to baseline during volume-controlled continuous mandatory ventilation before extubation. HFNC improved EELI in both the ventral (conventional O 2  vs HFNC, -48.2% ± 41.0 vs -30.0% ± 40.3,  P  < .001) and the dorsal (conventional O 2  vs HFNC, -37.0% ± 75.9 vs -26.5% ± 68.4,  P  = .02) regions of the lungs. Subjective subject-reported scores indicated that HFNC was more comfortable than conventional O 2  (conventional O 2  vs HFNC, 5.8 ± 1.5 vs 6.9 ± 1.9,  P  = .02). No differences were found in the other examined parameters. A head-up tilt position with conventional O 2  improved EELI in the dorsal regions (55.9% ± 100.1,  P  < .001) but not in the ventral regions (-37.9% ± 43.1%,  P  = .38) of the lungs compared to HFNC or conventional O 2  alone.
CONCLUSIONS


In post-abdominal surgery subjects who had been extubated, HFNC improved lung volume and patient comfort. A head-up tilt position introduced a heterogeneous increase in EELI in the dorsal regions of the lungs. HFNC therapy may be beneficial in this patient group. (ChiCTR1900020886, http://chictr.org.cn).",2020,"Subjective subject-reported scores indicated that HFNC was more comfortable than conventional O 2  (conventional O 2  vs HFNC, 5.8 ± 1.5 vs 6.9 ± 1.9,  P  = .02).","['18 subjects who were successfully weaned from ventilator support after abdominal surgery were included in the study', 'post-abdominal surgery patients']","['HFNC therapy', 'HFNC', 'high-flow nasal cannula (HFNC) therapy', 'Electrical Impedance Tomography', 'conventional oxygen (O 2 ) therapy', 'conventional O 2  was applied in group A for 15 min, and HFNC']","['Heart rate, blood pressure, breathing frequency, ratio of arterial partial pressure of oxygen to the fraction of inspired oxygen ( P   aO 2  / F   IO 2  ), and subject-reported comfort scores', 'HFNC improved EELI', 'extubated, HFNC improved lung volume and patient comfort', 'Changes in end-expiratory lung impedance (EELI', 'lung volume']","[{'cui': 'C1112479', 'cui_str': 'Respirator Weaning'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}]",,0.0332656,"Subjective subject-reported scores indicated that HFNC was more comfortable than conventional O 2  (conventional O 2  vs HFNC, 5.8 ± 1.5 vs 6.9 ± 1.9,  P  = .02).","[{'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Inéz', 'Initials': 'I', 'LastName': 'Frerichs', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Medical Centre of Schleswig-Holstein Campus Kiel, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Möller', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': 'Department of Critical Care Medicine xingjy@qduhospital.cn.'}, {'ForeName': 'Zhanqi', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}]",Respiratory care,['10.4187/respcare.07109']
1126,31738342,"Enteropathogens and Rotavirus Vaccine Immunogenicity in a Cluster Randomized Trial of Improved Water, Sanitation and Hygiene in Rural Zimbabwe.","BACKGROUND


Oral rotavirus vaccines (RVVs) are less efficacious in low-income versus high-income settings, plausibly due to more enteropathogen exposure through poor water, sanitation and hygiene (WASH). We explored associations between enteropathogens and RVV immunogenicity and evaluated the effect of improved WASH on enteropathogen carriage.
METHODS


We detected stool enteropathogens using quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay in infants enrolled to a cluster randomized 2 × 2 factorial trial of improved WASH and improved infant feeding in Zimbabwe (NCT01824940). We used multivariable regression to explore associations between enteropathogens and RVV seroconversion, seropositivity and geometric mean titer. We evaluated effects of improved WASH on enteropathogen prevalence using linear and binomial regression models with generalized estimating equations.
RESULTS


Among 224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54). RVV seroconversion was low (23.7%). After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96). There were otherwise no meaningful associations between individual or total pathogens (bacteria, viruses, parasites or all pathogens) and any measure of RVV immunogenicity. Enteropathogen detection did not differ between randomized WASH and non-WASH groups.
CONCLUSIONS


Enteropathogen infections were common around the time of rotavirus vaccination in rural Zimbabwean infants but did not explain poor RVV immunogenicity and were not reduced by a package of household-level WASH interventions.",2019,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","['224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54', 'rural Zimbabwean infants', 'Rural Zimbabwe']","['WASH', 'quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay', 'Oral rotavirus vaccines (RVVs']","['enteropathogens and RVV seroconversion, seropositivity and geometric mean titer', 'Enteropathogen detection', 'RVV seroconversion', 'RVV immunogenicity']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}]",224.0,0.235107,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002485']
1127,31733809,Assessment of anesthesia machine redesign on cleaning of the anesthesia machine using surface disinfection wipes.,"BACKGROUND


The use of surface disinfection wipes after induction of anesthesia improves anesthesia machine cleaning. We assessed whether anesthesia machine surface redesign improves disinfection wipe cleaning by anesthesia residents.
METHODS


Sixteen anesthesia residents were assigned to 2 cases in series. The first case was randomly assigned to regional knee or hip surgery, a brief or detailed checklist, and the Perseus A500 (redesigned) or GE Aespire 7900 (conventional) machine. The second case was assigned to the opposite for each condition. Setup checklists included cleaning instructions. Eight machine sites representing redesign were contaminated with fluorescent gel prior to setup and reassessed after setup to assess cleaning efficacy. Cleaning was compared by fluorescence quantification of before and after setup images. Our primary hypothesis was that, overall, more sites would be cleaned on the Perseus machine. Our secondary hypothesis was that redesign would affect some sites.
RESULTS


Overall, the number of sites cleaned did not differ between machines (median 0.74 more sites out of 8 for the Perseus A500; 25th and 75th percentiles, -0.34 and 1.04; P = .093). However, greater cleaning was observed for the work surface and manual bag arm/hose of the Perseus machine (0.58 more sites out of 2; 25th and 75th percentiles, 0.35 and 1.05; P = .0004).
CONCLUSIONS


The number of sites cleaned overall did not differ between the conventional and redesigned Perseus A500 machines. However, the redesigned work surface and smooth manual bag arm features improved resident cleaning with surface disinfection wipes.",2020,"Overall, the number of sites cleaned did not differ between machines (median 0.74 more sites out of 8 for the Perseus A500; 25th and 75th percentiles, -0.34 and 1.04; P = .093).",['Sixteen anesthesia residents'],"['regional knee or hip surgery, a brief or detailed checklist, and the Perseus A500 (redesigned) or GE Aespire 7900 (conventional) machine']","['number of sites cleaned overall', 'number of sites cleaned']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0172371,"Overall, the number of sites cleaned did not differ between machines (median 0.74 more sites out of 8 for the Perseus A500; 25th and 75th percentiles, -0.34 and 1.04; P = .093).","[{'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesia, University of Iowa Healthcare, Iowa City, IA.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Dexter', 'Affiliation': 'Department of Anesthesia, University of Iowa Healthcare, Iowa City, IA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Department of Biomedical Engineering, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Godding', 'Affiliation': 'Department of Anesthesia, University of Iowa Healthcare, Iowa City, IA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hadder', 'Affiliation': 'Department of Anesthesia, University of Iowa Healthcare, Iowa City, IA.'}, {'ForeName': 'Randy W', 'Initials': 'RW', 'LastName': 'Loftus', 'Affiliation': 'Department of Anesthesia, University of Iowa Healthcare, Iowa City, IA. Electronic address: randy-loftus@uiowa.edu.'}]",American journal of infection control,['10.1016/j.ajic.2019.09.016']
1128,32410657,OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial-statistical analysis plan.,"BACKGROUND


A chest X-ray is a standard imaging procedure in the diagnostic work-up of patients suspected of having non-traumatic pulmonary disease. Compared to a chest X-ray, an ultra-low-dose (ULD) chest computed tomography (CT) scan provides substantially more detailed information on pulmonary conditions. To what extent this translates into an improvement in patient outcomes and health care efficiency is yet unknown. The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) study is a multicenter, pragmatic, non-inferiority randomized controlled trial designed to evaluate replacement of chest X-ray by ULD chest CT in the diagnostic work-up of such patients, in terms of patient-related health outcomes and costs. During randomly assigned periods of 1 calendar month, either conventional chest X-ray or ULD chest CT scan was used as the imaging strategy. This paper presents in detail the statistical analysis plan of the OPTIMACT trial, developed prior to data analysis.
METHODS/RESULTS


Functional health at 28 days is the primary clinical outcome. Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1. Secondary outcomes are mental health (mental component summary scale of the SF-12), length of hospital stay, mortality within 28 days, quality-adjusted life year equivalent during the first 28 days (derived from the EuroQol five-dimension, five-level instrument), correct diagnoses at emergency department discharge as compared to the final post hoc diagnosis at day 28, number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT, and health care costs.
CONCLUSIONS


After this pragmatic trial we will have precise estimates of the effectiveness of replacing chest X-ray with ULD chest CT in terms of patient-related health outcomes and costs.
TRIAL REGISTRATION


Netherlands National Trial Register: NTR6163. Registered on 6 December 2016.",2020,Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1.,"['patients suspected of having non-traumatic pulmonary disease', 'patients suspected of non-traumatic pulmonary disease at the emergency department']","['replacing chest X-ray with ULD chest CT', 'chest X-ray by ULD chest CT', 'ultra-low-dose (ULD) chest computed tomography (CT) scan', 'conventional chest X-ray or ULD chest CT scan', 'chest X-ray or ultra-low-dose chest CT']","['Functional health', 'mental health (mental component summary scale of the SF-12), length of hospital stay, mortality within 28\u2009days, quality-adjusted life year equivalent during the first 28\u2009days (derived from the EuroQol five-dimension, five-level instrument), correct diagnoses at emergency department discharge']","[{'cui': 'C0522483', 'cui_str': 'Patient suspected of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0871583,Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1.,"[{'ForeName': 'Maadrika M N P', 'Initials': 'MMNP', 'LastName': 'Kanglie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands. m.m.kanglie@amsterdamumc.nl.'}, {'ForeName': 'Shandra', 'Initials': 'S', 'LastName': 'Bipat', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge A H', 'Initials': 'IAH', 'LastName': 'van den Berk', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick M M', 'Initials': 'PMM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}]",Trials,['10.1186/s13063-020-04343-w']
1129,31590926,Pharmacist linkage in care transitions: From academic medical center to community.,"OBJECTIVES


To improve the care of patients discharged from the University of Mississippi Medical Center (UMMC) after treatment for acute myocardial infarction, heart failure, pneumonia, and chronic obstructive pulmonary disease; reduce preventable hospital readmissions; and inform future care transition collaborations between hospital teams and community pharmacies.
SETTING


Study was conducted at UMMC, UMMC outpatient pharmacies, and targeted community pharmacies.
PRACTICE DESCRIPTION


UMMC is the state's only academic health science center, providing all levels of care. Participants were at UMMC's 722-bed hospital in Jackson, MS. Participating pharmacies included 2 UMMC outpatient pharmacies and community pharmacy research partner sites within 60 miles of UMMC.
PRACTICE INNOVATION


A pharmacist transitions coordinator (PTC) worked with inpatient and community-based pharmacists to provide predischarge medication reconciliation and 30 days of medications on discharge. The PTC with access to inpatient and outpatient records facilitated communication among settings/providers. Community pharmacists provided telephonic and face-to-face medication therapy management (MTM).
EVALUATION


The project was structured as a prospective, randomized controlled trial of pharmacist-led care coordination during transition from inpatient to community setting, with follow-up MTM by community pharmacists. In this intention-to-treat analysis, readmission rates were assessed with propensity adjustment. Drug therapy problems (DTPs) identified/resolved were assessed and reported through descriptive statistics.
RESULTS


Ninety-six patients were enrolled. Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment. Approximately 60% participated in MTM postdischarge, with 453 interventions and 169 DTPs identified and addressed (98% > 1 DTP; 20% > 5 DTPs). Implementation experience includes PTC successes, new partnerships, and connectivity among all providers, as well as enrollment challenges, follow-up, and service delivery timeframe.
CONCLUSION


With access to patient records, pharmacists have the potential to positively affect patient outcomes through medication management during care transitions.",2019,"Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment.","['Participating pharmacies included 2 UMMC outpatient pharmacies and community pharmacy research partner sites within 60 miles of UMMC', ""Participants were at UMMC's 722-bed hospital in Jackson, MS"", 'Study was conducted at UMMC, UMMC outpatient pharmacies, and targeted community pharmacies', 'Ninety-six patients were enrolled', 'patients discharged from the University of Mississippi Medical Center (UMMC) after treatment for acute myocardial infarction, heart failure, pneumonia, and chronic obstructive pulmonary disease']",['UMMC'],['readmission rates'],"[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0035168'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",[],[],96.0,0.0436658,"Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment.","[{'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Bloodworth', 'Affiliation': ''}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Malinowski', 'Affiliation': ''}, {'ForeName': 'Seth T', 'Initials': 'ST', 'LastName': 'Lirette', 'Affiliation': ''}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.08.011']
1130,24607553,"Randomized, double-blind, placebo-controlled trial of soluble tumor necrosis factor receptor: enbrel (etanercept) for the treatment of idiopathic pneumonia syndrome after allogeneic stem cell transplantation: blood and marrow transplant clinical trials network protocol.","Idiopathic pneumonia syndrome (IPS) is a diffuse, noninfectious lung injury that occurs acutely after allogeneic hematopoietic cell transplantation (HCT). IPS-related mortality has been historically high (>50%) despite treatment with systemic corticosteroids and supportive care measures. We have now examined the role of tumor necrosis factor inhibition in a randomized, double-blind, placebo-controlled trial of corticosteroids with etanercept or placebo. Thirty-four subjects (≥18 years) with IPS after HCT were randomized to receive methylprednisolone (2 mg/kg/day) plus etanercept (0.4 mg/kg twice weekly × 4 weeks; n = 16) or placebo (n = 18). No active infections and a pathogen-negative bronchoscopy were required at study entry. Response (alive, with complete discontinuation of supplemental oxygen support) and overall survival were examined. This study, originally planned to accrue 120 patients, was terminated prematurely due to slow accrual. In the limited number of patients examined, there were no differences in response rates at day 28 of study. Ten of 16 patients (62.5% [95% confidence interval {CI}, 35.4% to 84.8%]) receiving etanercept and 12 of 18 patients (66.7% [95% CI, 41.0% to 86.7%]) receiving placebo met the day 28 response definition (P = 1.00). The median survival was 170 days (95% CI, 11 to 362) with etanercept versus 64 days (95% CI, 26 to 209) with placebo (P = .51). Among responders, the median time to discontinuation of supplemental oxygen was 9 days (etanercept) versus 7 days (placebo). Therapy was well tolerated, with 1 toxicity-related death from infectious pneumonia in the placebo arm. The treatment of IPS with corticosteroids in adult HCT recipients was associated with high early response rates (>60%) compared with historical reports, with poor overall survival. The addition of etanercept did not lead to further increases in response, although the sample size of this truncated trial preclude a definitive conclusion.",2014,"Ten of 16 patients (62.5% [95% confidence interval {CI}, 35.4% to 84.8%]) receiving etanercept and 12 of 18 patients (66.7% [95% CI, 41.0% to 86.7%]) receiving placebo met the day 28 response definition (P = 1.00).","['120 patients, was terminated prematurely due to slow accrual', 'idiopathic pneumonia syndrome after allogeneic stem cell transplantation', 'Thirty-four subjects (≥18 years) with IPS after HCT', 'adult HCT recipients', 'Idiopathic pneumonia syndrome (IPS']","['corticosteroids with etanercept or placebo', 'placebo', 'methylprednisolone', 'soluble tumor necrosis factor receptor: enbrel (etanercept', 'allogeneic hematopoietic cell transplantation (HCT', 'etanercept']","['median survival', 'high early response rates', 'response rates', 'tolerated, with 1 toxicity-related death from infectious pneumonia', 'median time to discontinuation of supplemental oxygen', 'overall survival']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0720193', 'cui_str': 'Enbrel'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.741097,"Ten of 16 patients (62.5% [95% confidence interval {CI}, 35.4% to 84.8%]) receiving etanercept and 12 of 18 patients (66.7% [95% CI, 41.0% to 86.7%]) receiving placebo met the day 28 response definition (P = 1.00).","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Yanik', 'Affiliation': 'Department of Pediatrics and Internal Medicine, Blood and Marrow Transplant Program, University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: gyanik@umich.edu.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': 'Department of Internal Medicine, University of Minnesota Blood and Marrow Transplantation Program, Minneapolis, Minnesota.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Vincent T', 'Initials': 'VT', 'LastName': 'Ho', 'Affiliation': 'Department of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Department of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Carter', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Difronzo', 'Affiliation': 'Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Ferrara', 'Affiliation': 'Department of Pediatrics and Internal Medicine, Blood and Marrow Transplant Program, University of Michigan Medical Center, Ann Arbor, Michigan.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Department of Stem Cell Transplantation, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Madtes', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center and Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Drexler', 'Affiliation': 'National Marrow Donor Program, Minneapolis, Minnesota; Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'White', 'Affiliation': 'Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Michigan Medical Center, Ann Arbor, Michigan.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Cooke', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center, Johns Hopkins University, School of Medicine, Baltimore, Maryland.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2014.02.026']
1131,31730369,Effects of attentional bias modification therapy on the cue reactivity and cognitive control networks in participants with cocaine use disorders.,"BACKGROUND


While attentional bias modification therapy (ABMT) alters drug-related behaviors in some substance users, results have been mixed in individuals with cocaine use disorders (CUD).
OBJECTIVES


The current study examined whether ABMT affected brain functioning during independent measures of cue reactivity (i.e., cocaine versus food cues) and cognitive control (i.e., incongruent versus congruent trials), and whether brain activity was associated with baseline or post-intervention cocaine use.
METHODS


37 participants (62% male) were randomly assigned to ABMT or control therapy. Clinical and neuroimaging assessments occurred at baseline and immediately post-intervention, with additional clinical testing at 2 weeks and 3 months following intervention. Cocaine use was assessed through self-report.
RESULTS


Slower reaction times and increased functional activation (prefrontal cortex, posterior parietal cortex) were observed for incongruent versus congruent stimuli and increased functional activation for cocaine relative to food videos (ventral striatum, dorsolateral prefrontal cortex and orbitofrontal cortex). The default-mode network (DMN) was not deactivated during exposure to cocaine videos. The degree of activation during cocaine relative to food cues was associated with baseline cocaine use (insula only) and reduction in use following treatment (insula and anterior DMN) above and beyond clinical variables. Cognitive control network activity was not associated with cocaine use at baseline or following treatment. ABMT therapy did not differentially affect cocaine use or functional activation during either task.
CONCLUSION


Current results suggest a relationship between cue reactivity network activation and cocaine use, but question the efficacy of ABMT in changing brain function during cue reactivity or cognitive control tasks.",2020,"Slower reaction times and increased functional activation (prefrontal cortex, posterior parietal cortex) were observed for incongruent versus congruent stimuli and increased functional activation for cocaine relative to food videos (ventral striatum, dorsolateral prefrontal cortex and orbitofrontal cortex).","['Methods : 37 participants (62% male', 'participants with cocaine use disorders', 'individuals with cocaine use disorders (CUD']","['Cocaine', 'ABMT therapy', ' ', 'ABMT', 'attentional bias modification therapy', 'ABMT or control therapy', 'attentional bias modification therapy (ABMT']","['brain activity', 'cue reactivity and cognitive control networks', 'Cognitive control network activity', 'brain functioning', 'functional activation for cocaine relative to food videos (ventral striatum, dorsolateral prefrontal cortex and orbitofrontal cortex', 'Slower reaction times and increased functional activation (prefrontal cortex, posterior parietal cortex']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}]",37.0,0.0186149,"Slower reaction times and increased functional activation (prefrontal cortex, posterior parietal cortex) were observed for incongruent versus congruent stimuli and increased functional activation for cocaine relative to food videos (ventral striatum, dorsolateral prefrontal cortex and orbitofrontal cortex).","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Nonprofit Research Organization/Lovelace Biomedical and Environmental Research Institute , Albuquerque, NM, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Dodd', 'Affiliation': 'Nonprofit Research Organization/Lovelace Biomedical and Environmental Research Institute , Albuquerque, NM, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wilcox', 'Affiliation': 'Department of Psychiatry, University of New Mexico, 1 University of New Mexico , Albuquerque, NM, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Klimaj', 'Affiliation': 'Nonprofit Research Organization/Lovelace Biomedical and Environmental Research Institute , Albuquerque, NM, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Claus', 'Affiliation': 'Nonprofit Research Organization/Lovelace Biomedical and Environmental Research Institute , Albuquerque, NM, USA.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Nonprofit Research Organization/Lovelace Biomedical and Environmental Research Institute , Albuquerque, NM, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1671437']
1132,31732883,Effect of CPP-ACP on Streptococcus mutans in saliva of high caries-risk preschool children: a randomized clinical trial.,"PURPOSE


The aim of this study was to assess the efficacy of CPP-ACP in reducing salivary S. mutans levels and compare its effect as a dentifrice to use of a fluoride dentifrice alone, or with the sequential use of a combination of both agents (fluoride, then CPP-ACP) in three groups of preschool children over a 6-month period.
METHODS


This was a double-blinded clinical trial, the sample (n = 127, age 4.6 ± 0.47 years), with high caries risk, was randomized into three groups which applied different agents twice daily; fluoride toothpaste (500 ppm, n = 50), CPP-ACP (10% w/v, n = 38), and combination group (n = 39) applied fluoride, then CPP-ACP. S. mutans salivary levels were measured by GC Saliva-Check Mutans ™ .
RESULTS


Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05). The highest reduction in SMPC occurred in the CPP-ACP group, however, there were no significant differences in SMPC between groups at all study intervals, (P > 0.05).
CONCLUSION


Although all agents were effective, CPP-ACP showed the highest reduction in SMPC over 6-months.",2020,"Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05).","['sample (n\u2009=\u2009127, age 4.6\u2009±\u20090.47\xa0years), with high caries risk', 'Streptococcus mutans in saliva of high caries-risk preschool children', 'three groups of preschool children over a 6-month period']","['CPP-ACP', 'agents (fluoride, then CPP-ACP', 'fluoride toothpaste', 'fluoride, then CPP-ACP']","['S. mutans-positive children (SMPC', 'salivary S. mutans levels', 'S. mutans salivary levels', 'SMPC']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0337399,"Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05).","[{'ForeName': 'O B', 'Initials': 'OB', 'LastName': 'Al-Batayneh', 'Affiliation': 'Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan. olabt@just.edu.jo.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Al-Rai', 'Affiliation': 'Department of Preventive Dentistry, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Public Health and Epidemiology, Faculty of Medicine, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-019-00490-0']
1133,31068096,The study design of ComAlong Toddler: a randomised controlled trial of an early communication intervention.,"Aims:  This study design article aims to describe a research study focused on evaluating the use of the Infant-Toddler Checklist to identify children at 18 months with early communication difficulties, and to study the ComAlong Toddler intervention for parents to support their child's communication development.  Background : Communication disorders are a common public health problem affecting up to 20% of children. Evidence points to the importance of early detection and intervention to improve young children's communicative abilities and decrease developmental delay. Early identification of communication difficulties is possible with instruments such as Infant-Toddler Checklist. The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis. The parents are provided with guidance in communication enhancing strategies during home visit and five group sessions.  Methods : The study uses a prospective cohort design. Children were consecutively recruited during 2015-2017, and data will be collected 2015-2023. The screening was performed at the child health centre through use of the Infant-Toddler Checklist. An assessment and first consultation were then performed by a speech and language therapist for children with suspected communication delay according to the screen as well as for children referred for other reasons before the age of 2.5 years. Children with confirmed communication delay were randomised between two interventions: the ComAlong Toddler parental course or a telephone follow-up. Outcome measures include child communication and language skills and use of augmentative and alternative communication. To gain insight into the participants' perspectives, surveys have been collected from parents.  Conclusion:  The study will provide information regarding identification and intervention for 18-month old children with communication delay.  Trial registration: ISRCTN13330627.",2020,The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis.,"['children with suspected communication delay according to the screen as well as for children referred for other reasons before the age of 2.5\u2009years', ""children at 18\u2009months with early communication difficulties, and to study the ComAlong Toddler intervention for parents to support their child's communication development"", '18-month old children with communication delay', 'Children were consecutively recruited during 2015-2017, and data will be collected 2015-2023', 'Children with confirmed communication delay']",['ComAlong Toddler parental course or a telephone follow-up'],['child communication and language skills and use of augmentative and alternative communication'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",,0.0451563,The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fäldt', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Fabian', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Thunberg', 'Affiliation': 'Dart Centre for Augmentative and Alternative Communication (AAC) and Assistive Technology (AT), Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lucas', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Sweden.""}]",Scandinavian journal of public health,['10.1177/1403494819834755']
1134,31056081,Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial.,"BACKGROUND


Reduction of the pulse width has been reported to improve ECT outcomes with unilateral ECT (similar efficacy, fewer cognitive side effects), but has been minimally studied for bitemporal ECT. The only study comparing brief and ultrabrief pulse bitemporal ECT found reduced efficacy for bitemporal ultrabrief compared to bitemporal brief pulse stimulation. This randomised controlled trial (RCT) aimed to test if ultrabrief pulse bitemporal ECT results in fewer cognitive side effects than brief pulse bitemporal ECT, when given at doses adjusted with the aim of achieving comparable efficacy.
METHODS


Thirty-six participants were randomly assigned to receive ultrabrief (at 3 times seizure threshold) or brief (at 1.5 times seizure threshold) pulse bitemporal ECT given 3 times a week in a double-blind, controlled proof-of-concept trial. Blinded raters assessed mood and cognitive functioning over the ECT course.
RESULTS


Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course. The ultrabrief pulse group performed better on a test of visual memory assessed acutely after an ECT treatment.
CONCLUSIONS


This study suggests there may be a small cognitive advantage in giving bitemporal ECT with an ultrabrief pulse when dosage is increased to match the efficacy of brief pulse bitemporal ECT, but the study was underpowered to fully examine this issue.Clinical Trials Registration: www.clinicaltrials.gov, NCT00870805.",2020,Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course.,['Thirty-six participants'],"['ultrabrief pulse bitemporal ECT', 'ultrabrief pulse bitemporal electroconvulsive therapy', 'ultrabrief']","['mood and cognitive functioning', 'Efficacy and cognitive outcomes', 'cognitive side effects']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",36.0,0.17552,Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course.,"[{'ForeName': 'Donel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Katalinic', 'Affiliation': 'St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ingram', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ingram', 'Affiliation': 'The Melbourne Clinic, Melbourne, VIC, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Simpson', 'Affiliation': 'St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McGoldrick', 'Affiliation': 'Welsey Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'The Melbourne Clinic, Melbourne, VIC, Australia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Loo', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291719000989']
1135,29903473,"Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial.","BACKGROUND


Palmitate in breast milk is predominantly located in the triacylglycerol sn-2 position, while infant formulae contain palmitate predominantly in the sn-1 and sn-3 positions. During digestion, palmitate in the sn-1 and sn-3 positions is hydrolyzed to free palmitic acid that can subsequently complex with calcium to form insoluble soaps; this may partially explain why formula-fed infants have harder stools than breast-fed infants.
METHODS


This large (n = 488) randomized, double-blind, multicentre trial investigated whether increasing the sn-2 palmitate content of infant formula improves stool consistency and bone mineral content (measured by dual-energy x-ray absorptiometry), without affecting growth or health. From ∼1 week to 4 months of age, infants were exclusively fed one of three formulae: i) control formula (CF; 16% of total palmitate at sn-2; n = 162), (ii) experimental formula 1 (EF1; 43% of total palmitate at sn-2; n = 166) or (iii) experimental formula 2 (EF2; 51% of total palmitate at sn-2; n = 160).
RESULTS


Intention-to-treat analysis showed softer stools in both EF groups (vs. CF) at ages 2 weeks and 1 and 2 months (p ≤ 0.01), but not 3 and 4 months. At 4 months, all groups had similar growth outcomes while bone mineral content was significantly higher in EF1 (p = 0.0012) and EF2 (p = 0.0002) compared with CF. Comparison of reported adverse events up to 12 months revealed no differences among groups. All 3 infant formulae exhibited equally good digestive tolerance.
CONCLUSIONS


Formulae enriched in sn-2 palmitate fed in early infancy are safe, improve stool consistency (from 2 weeks to 2 months) and increase bone mineral content (at 4 months).",2019,Comparison of reported adverse events up to 12 months revealed no differences among groups.,['healthy term infants fed sn-2-palmitate-enriched starter infant formula'],"['total palmitate at sn-2; n\xa0=\xa0162), (ii) experimental formula 1 (EF1; 43% of total palmitate at sn-2; n\xa0=\xa0166) or (iii) experimental formula 2 (EF2; 51% of total palmitate at sn-2; n\xa0=\xa0160']","['stool consistency', 'Growth, stool consistency and bone mineral content', 'EF2', 'good digestive tolerance', 'bone mineral content', 'stool consistency and bone mineral content', 'softer stools']","[{'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0577115', 'cui_str': 'Soft stool (finding)'}]",488.0,0.484435,Comparison of reported adverse events up to 12 months revealed no differences among groups.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Béghin', 'Affiliation': ""Univ. Lille, Inserm, CHU Lille, CIC 1403 - Centre d'investigation clinique, F-59000 Lille, France; Univ. Lille, Inserm, CHU Lille, U995 - LIRIC - Lille Inflammation Research International Center, F-59000 Lille, France. Electronic address: laurent.beghin@chru-lille.fr.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Marchandise', 'Affiliation': 'Department of Nuclear Medicine, Lille University Hospital, Lille Hauts de France University, F-59000 Lille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lien', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Bricout', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bernet', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Lienhardt', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Jeannerot', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Menet', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Requillart', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': ""Ambulatory Paediatrician from the GREPA-Nord (Groupe de Recherche et d'Etudes en Pédiatrie Ambulatoire-Research and Study Group in Ambulatory Paediatrics from the North of France), French Association of Ambulatory Paediatrics, F-59000 Lille, France(1).""}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'De Groot', 'Affiliation': 'Nestlé Nutrition, Nestec Ltd, Vevey, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jaeger', 'Affiliation': 'Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Steenhout', 'Affiliation': 'Nestlé Health Science, Vevey, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': ""Univ. Lille, Inserm, CHU Lille, U995 - LIRIC - Lille Inflammation Research International Center, F-59000 Lille, France; Division of Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Jeanne de Flandre Lille University Children's Hospital and Lille University Faculty of Medicine, F-59000 Lille, France.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.015']
1136,29958706,Consumption of aged white wine modulates cardiovascular risk factors via circulating endothelial progenitor cells and inflammatory biomarkers.,"BACKGROUND & AIMS


There is compelling evidence showing that moderate alcohol consumption reduces cardiovascular risk factors related to atherosclerosis. The aim of this study was to evaluate the effects of aged white wine (AWW) and gin on circulating endothelial progenitor cells (EPC) and the expression of cell adhesion molecules, inflammatory cytokines and chemokines related to atherosclerosis in high cardiovascular risk subjects.
METHODS


This was an open, randomized, controlled, crossover study in 38 high-risk male volunteers between 55 and 80 years of age randomized to receive 30 g of ethanol/day as AWW or gin during 3 weeks. We used the paired two-tailed t-test to compare differences in outcome variables in response to each intervention. Carryover effects for the two periods were evaluated comparing the outcome variables before the AWW and gin interventions.
RESULTS


Compared to gin, AWW intake was associated with a significant 39.6% increase in EPCs. Expression of CD31 and CD40 in T-lymphocytes and of CCR2 and CD36 in monocytes also decreased significantly after AWW intake. In addition, compared to gin, AWW was associated with a significant decrease of plasma pro-inflammatory biomarkers interleukin-8 and interleukin-18 and vascular and intercellular adhesion molecules-1. Lfa-1, Mac-1, VLA4, CD40 and CD31 expression in monocytes and interferon gamma (IFN-γ) concentrations significantly decreased after intake of both alcoholic beverages.
CONCLUSIONS


AWW shows a greater ability to repair and maintain endothelial integrity compared to gin. This effect is probably due to grape-derived minor components in AWW, which are absent in gin.",2019,Expression of CD31 and CD40 in T-lymphocytes and of CCR2 and CD36 in monocytes also decreased significantly after AWW intake.,"['high cardiovascular risk subjects', '38 high-risk male volunteers between 55 and 80 years of age randomized to']","['aged white wine (AWW', 'receive 30\xa0g of ethanol']","['Carryover effects', 'Expression of CD31 and CD40 in T-lymphocytes and of CCR2 and CD36 in monocytes', 'plasma pro-inflammatory biomarkers interleukin-8 and interleukin-18 and vascular and intercellular adhesion molecules-1', 'Lfa-1, Mac-1, VLA4, CD40 and CD31 expression in monocytes and interferon gamma (IFN-γ) concentrations', 'EPCs']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0349372', 'cui_str': 'White wine (substance)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0079717', 'cui_str': 'Leukocyte Function Associated Antigen-1'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",38.0,0.0794092,Expression of CD31 and CD40 in T-lymphocytes and of CCR2 and CD36 in monocytes also decreased significantly after AWW intake.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBEROBN) Instituto de Salud Carlos III (ISCIII), Spain.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Medina-Remón', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBEROBN) Instituto de Salud Carlos III (ISCIII), Spain.""}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Lamuela-Raventós', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBEROBN) Instituto de Salud Carlos III (ISCIII), Spain; Nutrition and Food Science Department-XaRTA, INSA, Pharmacy School, University of Barcelona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBEROBN) Instituto de Salud Carlos III (ISCIII), Spain. Electronic address: restruch@clinic.ub.es.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.06.001']
1137,31708060,Stroke Warning Information and Faster Treatment (SWIFT): Cost-Effectiveness of a Stroke Preparedness Intervention.,"BACKGROUND


Less than 25% of stroke patients arrive to an emergency department within the 3-hour treatment window.
OBJECTIVE


We evaluated the cost-effectiveness of a stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT]), a stroke intervention demonstrating capacity to decrease race-ethnic disparities in ED arrival times.
METHODS


Using the literature and SWIFT outcomes for 2 interventions, enhanced educational (EE) materials, and interactive intervention (II), we assess the cost-effectiveness of SWIFT in 2 ways: (1) Markov model, and (2) cost-to-outcome ratio. The Markov model primary outcome was the cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY. The primary cost-to-outcome endpoint was cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity. We assessed the ICER of II and EE versus standard care (SC) from a health sector and societal perspective using 2015 USD, a time horizon of 5 years, and a discount rate of 3%.
RESULTS


The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity. Using a societal perspective, the ICER for EE versus SC was $84 643 per QALY gained and the ICER for II versus EE was $59 058 per QALY gained. Incorporating fixed costs, EE and II would need to administered to 507 and 1693 or more patients, respectively, to achieve an ICER of $100 000/QALY.
CONCLUSION


II was a cost-effective strategy compared with both EE and SC. Nevertheless, high initial fixed costs associated with II may limit its cost-effectiveness in settings with smaller patient populations.",2019,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.",[],"['stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT', 'Stroke Warning Information and Faster Treatment (SWIFT', 'Stroke Preparedness Intervention']","['Cost-Effectiveness', 'ICER of II and EE versus standard care (SC', 'cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity', 'cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY', 'cost-effectiveness']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1831581', 'cui_str': 'Subfamily Apodinae'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",,0.0544505,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stevens', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA; Department of Population Health, New York University School of Medicine, New York, NY, USA. Electronic address: elizabeth.stevens@nyumc.org.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Heather Carman', 'Initials': 'HC', 'LastName': 'Kuczynski', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Boden-Albala', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.06.003']
1138,30025745,Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials.,"BACKGROUND & AIMS


Preservation of lean body mass is an important cancer care objective. The capacity for prehabilitation interventions to modulate the lean body mass (LBM) of colorectal cancer patients before and after surgery is unknown.
METHODS


A pooled analysis of two randomized controlled trials of trimodal prehabilitation vs. trimodal rehabilitation at a single university-affiliated tertiary center employing Enhanced Recovery After Surgery (ERAS) care was conducted. The prehabilitation interventions included exercise, nutrition, and anxiety-reduction elements that began approximately four weeks before surgery and continued for eight weeks after surgery. The rehabilitation interventions were identical to the prehabilitation interventions but were initiated only after surgery. Body composition, measured using multifrequency bioelectrical impedance analysis, was recorded at baseline, pre-surgery, 4 and 8 weeks after surgery. The primary outcome was change in LBM before and after colorectal surgery for cancer. A mixed effects regression model was used to estimate changes in body mass and body composition over time controlling for age, sex, baseline body mass index (BMI), baseline six-minute walk test (6MWT), and postoperative compliance to the interventions. NCT02586701 &NCT01356264.
RESULTS


Pooled data included 76 patients who followed prehabilitation and 63 patients who followed rehabilitation (n = 139). Neither group experienced changes in preoperative LBM. Compared to rehabilitated patients, prehabilitated patients had significantly more absolute and relative LBM at four and eight-weeks post-surgery in models controlling for age, sex, baseline BMI, baseline 6MWT, and compliance to the postoperative intervention.
CONCLUSION


Trimodal prehabilitation attenuated the post-surgical LBM loss compared to the loss observed in patients who received the rehabilitation intervention. Patients who receive neither intervention (i.e., standard of care) would be likely to lose more LBM. Offering a prehabilitation program to colorectal cancer patients awaiting resection is a useful strategy to mitigate the impact of the surgical stress response on lean tissue in an ERAS setting, and, in turn, might have a positive impact on the cancer care course.
CLINICAL TRIAL REGISTRATION


NCT02586701 &NCT01356264 (clinicaltrials.gov).",2019,"The capacity for prehabilitation interventions to modulate the lean body mass (LBM) of colorectal cancer patients before and after surgery is unknown.
","['76 patients who followed prehabilitation and 63 patients who followed rehabilitation (n\xa0=\xa0139', 'lean body mass', 'at a single university-affiliated tertiary center employing Enhanced Recovery', 'colorectal cancer patients awaiting resection']",['trimodal prehabilitation vs. trimodal rehabilitation'],"['absolute and relative LBM', 'change in LBM before and after colorectal surgery for cancer', 'exercise, nutrition, and anxiety-reduction elements', 'preoperative LBM', 'body mass and body composition over time controlling for age, sex, baseline body mass index (BMI), baseline six-minute walk test (6MWT), and postoperative compliance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",76.0,0.148085,"The capacity for prehabilitation interventions to modulate the lean body mass (LBM) of colorectal cancer patients before and after surgery is unknown.
","[{'ForeName': 'Chelsia', 'Initials': 'C', 'LastName': 'Gillis', 'Affiliation': 'Cumming School of Medicine, Department of Community Health Sciences, University of Calgary, AB, Canada. Electronic address: chelsia.gillis@ucalgary.ca.'}, {'ForeName': 'Tanis R', 'Initials': 'TR', 'LastName': 'Fenton', 'Affiliation': ""Community Health Sciences, Institute of Public Health, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, and Nutrition Services, Alberta Health Services, AB, Canada.""}, {'ForeName': 'Tolulope T', 'Initials': 'TT', 'LastName': 'Sajobi', 'Affiliation': ""Cumming School of Medicine, Department of Community Health Sciences & O'Brien Institute for Public Health, University of Calgary, Calgary, Canada.""}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah-Ève', 'Initials': 'SÈ', 'LastName': 'Loiselle', 'Affiliation': 'Department of Nutrition and Food Services, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.06.982']
1139,31033396,Taking Repeated Exposure into Account: An Experimental Study of Direct-To-Consumer Prescription Drug Television Ad Effects.,"Introduction : Little is known about how repeated exposure to direct-to-consumer prescription drug promotion can impact consumers' retention and perceptions of drug information. The study described here tested the effects of varied ad exposure frequency on these outcomes.  Methods : In an in-person experiment, participants with seasonal allergies ( n  = 616) were randomized to view a mock prescription drug television ad either once, twice, or four times within 1 h of television programming, embedded with six commercial breaks. Respondents then answered a 20-min survey administered via computer.  Results : Those who viewed the ad more frequently were better able to recall both risk ( X 2  = 20.93,  p  < .001) and benefit information ( X 2  = 9.34,  p  = .009) and to recognize risk ( F (2,597) = 11.89,  p  = .001) and benefit information ( F (2,597) = 3.17,  p  = .043) than those who viewed the ad one time. Ad exposure frequency was not associated with perceptions about the magnitude or likelihood of risks or benefits. In general, risk information seemed to require more repetitions than benefit information to be accurately remembered. The recall was mediated by elaborate processing.  Discussion : Effects on memory were small; retention of both risks and benefits remained low overall even after four exposures.",2019,"Those who viewed the ad more frequently were better able to recall both risk (X 2  = 20.93, p < .001) and benefit information (X 2  = 9.34, p = .009) and to recognize risk (F(2,597) =",['participants with seasonal allergies (n = 616'],[],[],"[{'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}]",[],[],616.0,0.0425935,"Those who viewed the ad more frequently were better able to recall both risk (X 2  = 20.93, p < .001) and benefit information (X 2  = 9.34, p = .009) and to recognize risk (F(2,597) =","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'a U.S. Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , MD , USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a U.S. Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , MD , USA.'}, {'ForeName': 'Bridget J', 'Initials': 'BJ', 'LastName': 'Kelly', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parvanta', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mack', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tzeng', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cameron', 'Affiliation': 'c Psychological Sciences, School of Social Sciences, Humanities, and Arts, University of California, Merced , Merced , CA , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1609139']
1140,31609774,Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial.,"OBJECTIVES


Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock.
DESIGN


Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials.
SETTING


ICU of a tertiary care hospital.
PATIENTS


Two-hundred fifty patients 18 years old or older with cancer and septic shock.
INTERVENTIONS


Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
CONCLUSIONS


In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.",2019,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","['Cancer Patients', 'patients with vasodilatory shock', 'cancer patients with septic shock', 'Two-hundred fifty patients 18 years old or older with cancer and septic shock', '250 patients were randomized', 'ICU of a tertiary care hospital']","['vasopressin or norepinephrine', 'norepinephrine', 'Vasopressin Versus Norepinephrine', 'vasopressin']","['28-day mortality rate', '90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score', 'number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score', '90-day mortality', 'cause mortality', 'prevalence of adverse effects']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}]","[{'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",250.0,0.621102,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","[{'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Zambolim', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Juliano Pinheiro', 'Initials': 'JP', 'LastName': 'de Almeida', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Section of Anaesthetics, Pain Medicine and Intensive Care, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Clarice Hyesuk Lee', 'Initials': 'CHL', 'LastName': 'Park', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julia Tizue', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephanie Itala', 'Initials': 'SI', 'LastName': 'Rizk', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tais Felix', 'Initials': 'TF', 'LastName': 'Szeles', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nestor Cordeiro', 'Initials': 'NC', 'LastName': 'Dos Santos Neto', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto Kalil', 'Initials': 'RK', 'LastName': 'Filho', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Filomena Regina Barbosa Gomes', 'Initials': 'FRBG', 'LastName': 'Galas', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004023']
1141,31060718,"Effectiveness of an oral diabetes-specific supplement on nutritional status, metabolic control, quality or life, and functional status in elderly patients. A multicentre study.","BACKGROUND & AIMS


The purpose of this study was to assess nutritional status, quality of life (QoL) and function in malnourished or at risk for malnutrition community-dwelling (CD) and nursing home-dwelling (NHD) elderly patients with type 2 diabetes mellitus (DM2), receiving treatment with a diabetes-specific oral nutritional supplement (DSONS).
METHODS


A prospective, multicentre, observational study was conducted. A DSONS (high-calorie, high-protein, with slow-digestible carbohydrate and high monounsaturated fatty acid - MUFA-content - Glucerna ®  1.5 Cal) had been prescribed the week before inclusion. The following assessments were undertaken at baseline (BL), at week 6 (V1) and at month 3 (FV): body mass index (BMI), glycosylated haemoglobin (HbA 1c ), nutritional status (Mini Nutritional Assessment - MNA), QoL (EQ-5D questionnaire), and functional status (Katz Index - KI of Independence in Activities of Daily Living). The data were reported in the overall population (OP) and in the CD and NHD groups.
RESULTS


A total of 402 patients aged 80.8 ± 8.5 years were evaluable (44.5% men), including 61.7% CD and 38.3% NHD. BMI (kg/m 2 ) increased in the OP from 22.0 ± 3.5 at BL to 22.5 ± 3.6 at V1 (p < 0.001) and 23.0 ± 3.7 at the FV (p < 0.001). BMI also increased in the CD group (p < 0.001) and in the NHD group (p < 0.001). HbA 1c  decreased in the OP from 7.3 ± 1.1% at BL to 7.2 ± 1.0% at V1 and 7.0 ± 0.9% at the FV (p < 0.001), in both the CD (p < 0.001) and the NHD groups (p = 0.020). The mean overall MNA score increased in the OP from 13.1 ± 4.8 at BL to 17.0 ± 4.7 at V1 and 18.6 ± 5.1 at the FV (p < 0.001). The mean overall MNA score also increased in the CD (p < 0.001) and the NHD groups (p < 0.001). The mean overall EQ-5D score improved in the OP from 46.0 ± 18.0 at BL to 54.8 ± 17.5 at V1 and 59.7 ± 18.8 at the FV (p < 0.001). The mean overall EQ-5D score also improved in the CD (p < 0.001) and the NHD groups (p < 0.001). Gastrointestinal adverse events were seen in only 2% of patients. Treatment compliance was 94.4%.
CONCLUSIONS


In this study, conducted in routine, multicentre, clinical settings, the treatment with the high-calorie, high-protein, with slow-digestible carbohydrate, and high MUFA content DSNOS - Glucerna ®  1.5 Cal-, was associated with improvements in HbA 1c , nutritional status, BMI and QoL following 6 weeks and 3 months of treatment in both institutionalised and non-institutionalised elderly patients with diabetes who were malnourished or at risk for malnutrition. A slight improvement in functional status was also observed at 12 weeks. As this is an observational effectiveness study, a randomized controlled trial would be necessary to establish a causal relationship between the DSNOS and the described events.",2019,The mean overall MNA score also increased in the CD (p < 0.001) and the NHD groups (p < 0.001).,"['elderly patients with diabetes who were malnourished or at risk for malnutrition', 'malnourished or at risk for malnutrition community-dwelling (CD) and nursing home-dwelling (NHD) elderly patients with type 2 diabetes mellitus (DM2), receiving treatment with a diabetes-specific oral nutritional supplement (DSONS', 'elderly patients', '402 patients aged 80.8\xa0±\xa08.5 years were evaluable (44.5% men), including 61.7% CD and 38.3% NHD']",['oral diabetes-specific supplement'],"['Gastrointestinal adverse events', 'nutritional status, metabolic control, quality or life, and functional status', 'BMI', 'mean overall EQ-5D score', 'nutritional status, quality of life (QoL) and function', 'HbA 1c  decreased in the OP', 'mean overall MNA score', 'functional status', 'body mass index (BMI), glycosylated haemoglobin (HbA 1c ), nutritional status (Mini Nutritional Assessment - MNA), QoL (EQ-5D questionnaire), and functional status (Katz Index - KI\xa0of Independence in Activities of Daily Living']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0184549', 'cui_str': 'At risk for malnutrition'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living (assessment scale)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",402.0,0.0264296,The mean overall MNA score also increased in the CD (p < 0.001) and the NHD groups (p < 0.001).,"[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matia Martin', 'Affiliation': 'Universidad Complutense de Madrid (UCM), Endocrinology and Nutrition Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain. Electronic address: pilar.matia@gmail.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Robles Agudo', 'Affiliation': 'Hospital Cantoblanco - La Paz de Madrid, Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Lopez Medina', 'Affiliation': 'Hospital Virgen de la Victoria de Malaga, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Sanz Paris', 'Affiliation': 'Hospital Miguel Servet de Zaragoza, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Tarazona Santabalbina', 'Affiliation': 'Hospital de la Ribera de Alzira (Valencia), Spain.'}, {'ForeName': 'Juan Ramon', 'Initials': 'JR', 'LastName': 'Domenech Pascual', 'Affiliation': 'Hospital de la Ribera de Alzira (Valencia), Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lopez Penabad', 'Affiliation': 'Hospital San Juan de Alicante, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Sanz Barriuso', 'Affiliation': 'Abbott Nutrition, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.007']
1142,31055879,Docetaxel-based chemotherapy combined with dexamethasone 1 mg daily oral administration for castration-resistant prostate cancer: Long-term outcomes.,"OBJECTIVES


To report long-term outcome survival analysis of docetaxel-based chemotherapy combined with dexamethasone in castration-resistant prostate cancer patients (Japan-Multinational Trial Organization Pca10-01 trial).
METHODS


The Japan-Multinational Trial Organization Pca10-01 phase II trial was a multicenter, prospective single-arm, phase II trial both in non-metastatic and metastatic castration-resistant prostate cancer patients that was organized by The Japan-Multinational Trial Organization. Patients received 75 mg/m 2  of docetaxel (every 21 days) and 0.5 mg of dexamethasone orally twice a day continuing throughout the treatment period. The primary end-point of this additional analysis was overall survival. Secondary end-points were progression-free survival and safety.
RESULTS


Between January 2011 and February 2014, a total of 76 chemotherapy-naïve castration-resistant prostate cancer patients were enrolled. The median overall survival time was 42.5 months. The median overall survival time of M1 patients was 40.5 months (M0: not reached). The median progression-free survival time was 13.2 months (M0: 15.7 months and M1: 12.3 months). The multivariate analysis predicting overall survival of M1 patients showed that time to castration-resistant prostate cancer (≥20 months) was an independent parameter (hazard ratio 0.39, P = 0.023). Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
CONCLUSIONS


Docetaxel-based chemotherapy combined with dexamethasone can achieve excellent survival efficacy not only in M0 castration-resistant prostate cancer patients, but also in M1 castration-resistant prostate cancer patients.",2019,"Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
","['castration-resistant prostate cancer patients (Japan-Multinational Trial Organization Pca10-01 trial', 'M0 castration-resistant prostate cancer patients', 'Between January 2011 and February 2014, a total of 76 chemotherapy-naïve castration-resistant prostate cancer patients were enrolled', 'non-metastatic and metastatic castration-resistant prostate cancer patients that was organized by The Japan-Multinational Trial Organization', 'castration-resistant prostate cancer', 'The Japan-Multinational Trial Organization']","['docetaxel-based chemotherapy combined with dexamethasone', 'Docetaxel-based chemotherapy combined with dexamethasone', 'dexamethasone', 'docetaxel']","['median overall survival time', 'grade of adverse events', 'grade ≥3 adverse events', 'survival efficacy', 'progression-free survival and safety', 'median progression-free survival time', 'overall survival']","[{'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1300195', 'cui_str': 'Being organized'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",74.0,0.154792,"Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
","[{'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Eijiro', 'Initials': 'E', 'LastName': 'Okajima', 'Affiliation': 'Department of Urology, Nara City Hospital, Nara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ina', 'Affiliation': 'Department of Chemotherapy, Nagoya Memorial Hospital, Nagoya, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Department of Urology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Nagata', 'Affiliation': 'Department of Urology, Keio University, Tokyo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Akakura', 'Affiliation': 'Department of Urology, JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': 'Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Hirao', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14009']
1143,31731111,"MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial.","BACKGROUND


SSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA.
AIM


To determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania.
METHODS


Open-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days. The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires.
CONCLUSIONS


Expanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.",2020,"Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA.
","['Sub-Saharan African stroke survivors', 'Tanzania', 'Open-label, phase II clinical trial enrolling up to 120 patients', 'Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90\u202fdays']","['fluoxetine', 'MAMBO', 'Fluoxetine']","['1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability', '1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires', 'Measuring ambulation, motor, and behavioral outcomes']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}]",120.0,0.126256,"Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA.
","[{'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Vogel', 'Affiliation': 'Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: avogel@partners.org.'}, {'ForeName': 'Kigocha', 'Initials': 'K', 'LastName': ""Okeng'o"", 'Affiliation': 'Muhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania.'}, {'ForeName': 'Faraja', 'Initials': 'F', 'LastName': 'Chiwanga', 'Affiliation': 'Muhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: faraja.chiwanga@mnh.or.tz.'}, {'ForeName': 'Seif Sharif', 'Initials': 'SS', 'LastName': 'Ismail', 'Affiliation': 'Muhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deus', 'Initials': 'D', 'LastName': 'Buma', 'Affiliation': 'Muhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: deus.buma@mnh.or.tz.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: lmpothier@partners.org.'}, {'ForeName': 'Farrah J', 'Initials': 'FJ', 'LastName': 'Mateen', 'Affiliation': 'Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA. Electronic address: fmateen@partners.org.'}]",Journal of the neurological sciences,['10.1016/j.jns.2019.116563']
1144,32410694,"Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study.","BACKGROUND


Atabecestat, a potent brain-penetrable inhibitor of BACE1 activity that reduces CSF amyloid beta (Aβ), was developed for oral treatment for Alzheimer's disease (AD). The long-term safety and effect of atabecestat on cognitive performance in participants with predementia AD in two phase 2 studies were assessed.
METHODS


In the placebo-controlled double-blind parent ALZ2002 study, participants aged 50 to 85 years were randomized (1:1:1) to placebo or atabecestat 10 or 50 mg once daily (later reduced to 5 and 25 mg) for 6 months. Participants entered ALZ2004, a 12-month treatment extension with placebo or atabecestat 10 or 25 mg, followed by an open-label phase. Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance were assessed.
RESULTS


Of 114 participants randomized in ALZ2002, 99 (87%) completed, 90 entered the ALZ2004 double-blind phase, and 77 progressed to the open-label phase. CSF Aβ fragments and sAPPβ were reduced dose-proportionately. Decreases in whole brain and hippocampal volumes were greater in participants with mild cognitive impairment (MCI) due to AD than in preclinical AD, but were not affected by treatment. In ALZ2004, change from baseline in RBANS trended toward worse scores for atabecestat versus placebo. Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring. Treatment discontinuation normalized ALT or AST in all except one with pretreatment elevation, which remained mildly elevated. No case met ALT/AST > 3× ULN and total bilirubin > 2× ULN (Hy's law).
CONCLUSION


Atabecestat was associated with trend toward declines in cognition, and elevation of liver enzymes.
TRIAL REGISTRATION


ALZ2002: ClinicalTrials.gov, NCT02260674, registered October 9, 2014; ALZ2004: ClinicalTrials.gov, NCT02406027, registered April 1, 2015.",2020,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[""early Alzheimer's disease spectrum patients"", 'participants aged 50 to 85\u2009years', '114 participants randomized in ALZ2002, 99 (87%) completed', 'participants with predementia AD in two phase 2 studies were assessed', ""Alzheimer's disease (AD""]","['placebo or atabecestat 10 or 25\u2009mg, followed by an open-label phase', 'atabecestat', 'placebo or atabecestat', 'atabecestat (JNJ-54861911', 'placebo-controlled double-blind parent ALZ2002', 'placebo']","['cognitive performance', 'cognition, and elevation of liver enzymes', 'total bilirubin', 'Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance', 'whole brain and hippocampal volumes', 'Elevated liver enzyme adverse events', 'frequency of safety monitoring']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",114.0,0.639533,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Novak', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA. gnovak1@its.jnj.com.'}, {'ForeName': 'Johannes Rolf', 'Initials': 'JR', 'LastName': 'Streffer', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Timmers', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henley', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'H Robert', 'Initials': 'HR', 'LastName': 'Brashear', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bogert', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Russu', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Tesseur', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tritsmans', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Engelborghs', 'Affiliation': 'Reference Center for Biological Markers of Dementia (BIODEM), Institute Born-Bunge, University of Antwerp, Antwerp, Belgium.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00614-5']
1145,29493266,Effects of brief mindfulness-based cognitive behavioural therapy on health-related quality of life and sense of coherence in atrial fibrillation patients.,"BACKGROUND


The aim of this study was to evaluate the effects of a brief dyadic cognitive behavioural therapy (CBT) programme on the health-related quality of life (HRQoL), as well as the sense of coherence in atrial fibrillation patients, up to 12 months post atrial fibrillation.
METHODS


A longitudinal randomised controlled trial with a pre and 12-month post-test recruitment of 163 persons and their spouses, at a county hospital in southern Sweden. In all, 111 persons were randomly assigned to either a CBT ( n=56) or a treatment as usual (TAU) group ( n=55). The primary outcome was changes in the HRQoL (Euroqol questionnaire; EQ-5D), and the secondary outcomes were changes in psychological distress (hospital anxiety and depression scale; HADS) and sense of coherence (sense of coherence scale; SOC-13).
RESULTS


At the 12-month follow-up, the CBT group experienced a higher HRQoL than the TAU group (mean changes in the CBT group 0.062 vs. mean changes in the TAU group -0.015; P=0.02). The sense of coherence improved in the CBT group after the 12-month follow-up, compared to the TAU group (mean changes in the CBT group 0.062 vs. mean changes in the TAU group -0.16; P=0.04). The association between the intervention effect and the HRQoL was totally mediated by the sense of coherence ( z=2.07, P=0.04).
CONCLUSIONS


A dyadic mindfulness-based CBT programme improved HRQoL and reduced psychological distress up to 12 months post atrial fibrillation. The sense of coherence strongly mediated the HRQoL; consequently, the sense of coherence is an important determinant to consider when designing programmes for atrial fibrillation patients.",2018,"The sense of coherence improved in the CBT group after the 12-month follow-up, compared to the TAU group (mean changes in the CBT group 0.062 vs. mean changes in the TAU group -0.16; P=0.04).","['104 persons', '163 persons and their spouses, at a county hospital in southern Sweden', 'atrial fibrillation patients', 'atrial fibrillation patients, up to 12 months post atrial fibrillation']","['brief mindfulness-based cognitive behavioural therapy', 'usual (TAU', 'dyadic cognitive behavioural therapy (CBT) programme', 'CBT']","['HRQoL (Euroqol questionnaire; EQ-5D', 'HRQoL and reduced psychological distress', 'health-related quality of life (HRQoL', 'psychological distress (hospital anxiety and depression scale; HADS) and sense of coherence (sense of coherence scale; SOC-13', 'sense of coherence', 'health-related quality of life and sense of coherence']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C3178983', 'cui_str': 'Salutogeneses'}, {'cui': 'C0222045'}]",104.0,0.0353082,"The sense of coherence improved in the CBT group after the 12-month follow-up, compared to the TAU group (mean changes in the CBT group 0.062 vs. mean changes in the TAU group -0.16; P=0.04).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Malm', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Fridlund', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Ekblad', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Karlström', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hag', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': '1 School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118762796']
1146,32410683,Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up.,"BACKGROUND


Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
METHODS


In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
RESULTS


Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
CONCLUSIONS


Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
TRIAL REGISTRATION


The trial was retrospectively registered on February 2, 2010.
TRIAL REGISTRATION NUMBER


https://www.clinicaltrials.gov Identifier: NCT01060189.",2020,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","['patients receiving cardiac surgery with cardiopulmonary bypass (CPB', 'heart surgery with CPB', '426 consecutive patients receiving open heart surgery with CPB', 'patients receiving cardiac surgery with cardiopulmonary bypass']","['Ulinastatin', 'normal saline', 'placebo, ulinastatin', 'tranexamic acid', 'ulinastatin']","['blood loss and allogeneic transfusion', 'volume of post-operative blood loss', 'bleeding and transfusion outcomes', 'mortality and major morbidity', 'total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality', 'volume of allogeneic erythrocyte transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",426.0,0.171357,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Anaesthesiology, People's Hospital of Ningxia Hui Autonomous Region, 148 Huaiyuanxi Rd. Xixia District, Ningxia Hui Autonomous Region, Yinchuan, 750021, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lihuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China. shijia@fuwai.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01144-9']
1147,32410684,A sex education program for teachers of preschool children: a quasi-experimental study in Iran.,"BACKGROUND


Sex education is an important educational dimension. Together with families, teachers play a significant role in providing sex education to children. However, in most cases, they do not have enough information on this topic. The present study aimed to determine the effects of a preschool sex education program on preschool teachers' knowledge and attitude.
METHODS


In this quasi-experimental study, 80 teachers working at preschools in Tehran, Iran, were randomly allocated to experimental and control groups. The educational program was provided in two 90-min sessions for the experimental group while the control group received no intervention. A self-designed knowledge and attitude questionnaire was completed by both groups before and 1 month after the intervention. This questionnaire evaluated knowledge and attitude in six domains of principles of sex education, sexual identity, stages of development and proper methods of sex education, sex-related questions, masturbation, and sexual abuse. Data were analysed in SPSS 18 using descriptive statistics as well as independent samples t-test, paired-samples t-test, chi-squared test, and ANCOVA at p < 0.05.
RESULTS


Mean scores of knowledge and attitude in all dimensions showed a significant increase in the experimental group following the educational intervention. However, no difference was observed in the control group. Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
CONCLUSIONS


Results revealed that the sex education program can promote the knowledge and attitude of preschool teachers in all domains.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials: IRCT2016122320854N5. Registered on 9 March 2017. ""Retrospectively registered"".",2020,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","['80 teachers working at preschools in Tehran, Iran', 'teachers of preschool children']","['preschool sex education program', 'control group received no intervention']","[""preschool teachers' knowledge and attitude"", 'Mean scores of knowledge and attitude', ""mean scores of teachers' knowledge and attitude""]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0143106,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","[{'ForeName': 'Jeno', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Midwifery and Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedyeh', 'Initials': 'H', 'LastName': 'Riazi', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, ValiAsr Ave., Cross of Niayesh Highway and ValiAsr, Tehran, 1996835119, Iran. h.riazi@sbmu.ac.ir.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Firoozi', 'Affiliation': 'Department of Psychology, School of Psychology and Social Sciences, Islamic Azad University Roudehen branch, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC public health,['10.1186/s12889-020-08826-y']
1148,30460483,Using emotion regulation strategies after sleep deprivation: ERP and behavioral findings.,"Sleep deprivation is suggested to impact emotion regulation, but few studies have directly examined it. This study investigated the influence of sleep deprivation on three commonly used emotion regulation strategies (distraction, reappraisal, suppression) in Gross's (1998) process model of emotion regulation. Young healthy adults were randomly assigned to a sleep deprivation group (SD; n = 26, 13 males, age = 20.0 ± 1.7) or a sleep control group (SC; n = 25, 13 males, age = 20.2 ± 1.7). Following 24-h sleep deprivation or normal nighttime sleep, participants completed an emotion regulation task, in which they naturally viewed or applied a given emotion regulation strategy towards negative pictures, with electroencephalographic (EEG) recordings. A reduction in the centroparietal late positive potential (LPP) amplitudes towards negative pictures from the naturally viewing condition to a regulated condition was calculated as an index of regulatory effects. Comparisons between the two groups indicated that sleep deprivation significantly impaired the regulatory effects of distraction and reappraisal on LPP amplitudes. Suppression did not reduce LPP amplitudes in either group. In addition, habitual sleep quality moderated the effect of sleep deprivation on subjective perception of emotional stimuli, such that sleep deprivation only made good sleepers perceive negative pictures as more unpleasant and more arousing, but it had no significant effect on poor sleepers' perception of negative pictures. Altogether, this study provides the first evidence that sleep deprivation may impair the effectiveness of applying adaptive emotion regulation strategies (distraction and reappraisal), creating potentially undesirable consequences to emotional well-being.",2019,Comparisons between the two groups indicated that sleep deprivation significantly impaired the regulatory effects of distraction and reappraisal on LPP amplitudes.,"['group (SD; n = 26, 13 males, age = 20.0 ± 1.7) or a sleep control group (SC; n = 25, 13 males, age = 20.2 ± 1.7', 'Young healthy adults']","['emotion regulation strategies (distraction, reappraisal, suppression', 'sleep deprivation', '24-h sleep deprivation or normal nighttime sleep, participants completed an emotion regulation task, in which they naturally viewed or applied a given emotion regulation strategy towards negative pictures, with electroencephalographic (EEG) recordings']","['regulatory effects of distraction and reappraisal on LPP amplitudes', 'sleep deprivation', 'LPP amplitudes']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]",,0.0186449,Comparisons between the two groups indicated that sleep deprivation significantly impaired the regulatory effects of distraction and reappraisal on LPP amplitudes.,"[{'ForeName': 'Jinxiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China. jinx.zhang@stanford.edu.'}, {'ForeName': 'Esther Yuet Ying', 'Initials': 'EYY', 'LastName': 'Lau', 'Affiliation': 'Department of Psychology, The Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Janet Hui-Wen', 'Initials': 'JH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-018-00667-y']
1149,31728673,Lower prednisone dosing for steroid-sensitive nephrotic syndrome relapse: a prospective randomized pilot study.,"Relapses of steroid-sensitive nephrotic syndrome are traditionally treated with prednisone 2 mg/kg/day or 60 mg/m 2 /day. Retrospective data support the use of lower doses. We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse. The cohort included 30 children with relapsed steroid sensitive nephrotic syndrome, mean age 6.3 ± 3 years and mean disease duration 2.2 ± 1.8 years. The children were randomized to receive 2, 1.5, or 1 mg/kg/day prednisone. The corresponding times to response, defined as the first of 3 consecutive days without proteinuria, were 7.2 ± 1.4, 10.2 ± 5.1, and 9 ± 3.3 days; the difference between the 1.5 and 2 mg/kg/day groups was statistically significant. One patient each in the 1 mg/kg/day and the 1.5 mg/kg/day groups failed to respond and were switched to 2 mg/kg/day, leading to a response after 3 and 10 days, respectively. Mean cumulative prednisone doses in the 3 groups were 45.5 ± 3.4, 42.7 ± 25.9, and 24.9 ± 7.4 mg/kg, respectively (P < 0.05).Conclusion: In the present study, treatment of childhood steroid sensitive nephrotic syndrome relapse with prednisone 1-1.5 mg/kg/day led to a significantly lower cumulative dose than the standard dose. Treatment with a lower dose may be equally safe and effective to the standard dose.What is Known:• Relapses of steroid-sensitive nephrotic syndrome are traditionally treated with standard-dose steroids.• Treatment with corticosteroids may have significant adverse effects mainly with long-term use.What is New:• Treatment of steroid sensitive nephrotic syndrome relapse with 1-1.5 mg/kg/day prednisone may lead to a significantly lower cumulative dose.• Treatment with a lower steroid dose may be as effective as the standard dose in achieving remission of steroid sensitive nephrotic syndrome relapse.",2020,We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse.,"['30 children with relapsed steroid sensitive nephrotic syndrome, mean age 6.3\u2009±\u20093\xa0years and mean disease duration 2.2\u2009±\u20091.8\xa0years', 'sensitive nephrotic syndrome relapse']","['steroid', 'prednisone']",['Mean cumulative prednisone doses'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",30.0,0.020056,We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse.,"[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Borovitz', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Alfandary', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Haskin', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Shely', 'Initials': 'S', 'LastName': 'Levi', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Shulamit', 'Initials': 'S', 'LastName': 'Kaz', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davidovits', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dagan', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel. dagana@clalit.org.il.""}]",European journal of pediatrics,['10.1007/s00431-019-03506-5']
1150,31728675,Repeating a dose of sucrose for heel prick procedure in preterms is not effective in reducing pain: a randomised controlled trial.,"Oral sucrose is included in almost all recommendations for treatment of pain in newborns, but evidence if multiple doses might be more effective than a single standard dose is lacking. We designed a single-centre, double-blind, randomised, controlled trial. We enrolled preterm infants needing the heel prick procedure. Each enrolled infant was randomised to receive a single standard dose of sucrose 2 min before or a double dose of sucrose 2 min before, and 30 s after heel prick. Primary outcome was the efficacy of the two interventions tested by the premature infant pain profile-PIPP scale obtained at 30 s, 60 s, and 120 s after heel prick. Secondary outcome was the evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice. Seventy-two infants were randomised. No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline; 6.0(IQR 5.0-10.0) vs 6.0(IQR 4.0-8.5) at 30 s; 6.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-8.5) at 60 s and 5.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-7.5) at 2 min, in the experimental and standard treatment groups, respectively (p = 0.9020). There was no correlation between PIPP scores and other pain scales.Conclusion: We do not recommend doubling the dose during heel prick.What is Known:• Oral sucrose is included in almost all international position papers and recommendations for the treatment of mild to moderate pain in newborns, associated with non-nutritive sucking and facilitated tucking• Premature infant pain profile (PIPP) scale is the gold standard for evaluation of pain in preterms but it is difficult to use in clinical practiceWhat is New:• Repeating a dose of 24% sucrose is not effective in reducing pain during the recovery phase of a skin breaking procedure• Other pain scales, easier to use in clinical practice, are not comparable with PIPP for the evaluation of procedural pain in preterms.",2020,No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline;,"['enrolled preterm infants needing the heel prick procedure', 'Seventy-two infants were randomised']","['Oral sucrose', 'sucrose']","['PIPP scores and other pain scales', 'evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice', 'pain', 'pain perception', 'PIPP scale', 'premature infant pain profile-PIPP scale']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]",72.0,0.483889,No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline;,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lago', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Cavicchiolo', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy. mecavicchiolo@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Mion', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Dal Cengio', 'Affiliation': 'Neonatal Intensive Care Unit, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Allegro', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daverio', 'Affiliation': 'Paediatric Intensive Care Unit, Department of Woman and Child Health, University of Padua, Padua, Italy.'}, {'ForeName': 'Anna Chiara', 'Initials': 'AC', 'LastName': 'Frigo', 'Affiliation': 'Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua, Italy.'}]",European journal of pediatrics,['10.1007/s00431-019-03509-2']
1151,31730269,"Improvements in psychologists' metacommunication self-efficacy, willingness, and skill following online training and a supervision exercise.","OBJECTIVE(S)


Psychologists' experiences of an online training tool in metacommunication as well as an in-supervisory metacommunication exercise were examined.
METHOD


A total of 101 participants completed a training tool in metacommunication and changes in self-efficacy (SE) to use metacommunication with clients, the proportion of metacommunication used in vignette-responses, and their willingness to use metacommunication in supervision were assessed pre- and posttraining and at 6-week follow-up. A total of 48 participants elected to undertake the in-supervision exercise.
RESULTS


Participants reported significantly higher willingness and self-efficacy after completing the online training. They also showed a higher proportion of metacommunicative statements in their posttraining vignette responses compared with pretraining. The increase in willingness was retained at 6-week follow-up. There was an increase in self-efficacy from pre- to postonline-training, and this increased at follow-up.
CONCLUSIONS


This opens the door to better developing metacommunication skills in supervisees through both online training and the metacommunication supervisory exercise. Areas for continued research are outlined.",2020,They also showed a higher proportion of metacommunicative statements in their posttraining vignette responses compared with pretraining.,"['48 participants elected to undertake the in-supervision exercise', '101 participants']",['online training and a supervision exercise'],"['self-efficacy', 'willingness and self-efficacy', 'metacommunicative statements', ""psychologists' metacommunication self-efficacy, willingness, and skill""]","[{'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}]",101.0,0.0192548,They also showed a higher proportion of metacommunicative statements in their posttraining vignette responses compared with pretraining.,"[{'ForeName': 'Fiona L', 'Initials': 'FL', 'LastName': 'Calvert', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Discipline of Clinical Psychology, University of Technology Sydney, Ultimo, Australia.'}]",Journal of clinical psychology,['10.1002/jclp.22889']
1152,31727667,Evaluation of the Choosing Wisely Australia 5 Questions resource and a shared decision-making preparation video: protocol for an online experiment.,"INTRODUCTION


Choosing Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change. In Australia, Choosing Wisely has developed a 5 Questions resource to facilitate better conversations. The primary aim of this study is to evaluate the impact of the Choosing Wisely Australia 5 Questions resource and a video designed to prepare patients for question-asking and participation in shared decision-making on (a) self-efficacy to ask questions and participate in shared decision-making, (b) intention to participate in shared decision-making and (c) a range of secondary outcomes. The secondary aim of this study is to determine whether participants' health literacy modifies the effects of the interventions.
METHODS AND ANALYSIS


We will use 2×2×2 between-subjects factorial design (preparation video: yes, no × Choosing Wisely 5 Questions resource: yes, no × health literacy: adequate, inadequate). Participants will be recruited by an online market research company, presented with a hypothetical non-specific low back pain scenario, and randomised to study groups stratified by health literacy. Quantitative primary and secondary outcome data will be analysed as intention-to-treat using appropriate regression models (ie, linear regression for continuous outcomes, logistic regression for dichotomous categorical outcomes).
ETHICS AND DISSEMINATION


Ethical approval for this study was obtained from the University of Sydney Human Research Ethics Committee (protocol number: 2018/965). The results from this work will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies. Resources developed for this study will be made available to patients and clinicians following trial completion.
TRIAL REGISTRATION NUMBER


This trial has been registered with the Australia New Zealand Clinical Trials Registry (trial number: 376477) and the stage is Pre-results.",2019,"Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change.","['Participants will be recruited by an online market research company, presented with a hypothetical non-specific low back pain scenario', ""participants' health literacy""]",[],[],"[{'cui': 'C0024825', 'cui_str': 'Market Research'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],[],,0.22808,"Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change.","[{'ForeName': 'Danielle Marie', 'Initials': 'DM', 'LastName': 'Muscat', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia danielle.muscat@sydney.edu.au.'}, {'ForeName': 'Edward Hoi-Fan', 'Initials': 'EH', 'LastName': 'Chang', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Zadro', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jessica Kathleen', 'Initials': 'JK', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lindner', 'Affiliation': 'NPS Medicinewise, Strawberry Hills, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033126']
1153,31727672,Study protocol: a randomised non-inferiority trial using interactive virtual presence to remotely assist parents with child restraint installations.,"BACKGROUND


Motor vehicle crashes are the third-leading cause of death to American children aged 1-5 years. When installed correctly, child restraints (car seats) reduce risk of serious injury and death. However, most restraints are installed incorrectly. The current gold standard for correct installation is systematic car seat checks, where certified technicians help parents, but car seat checks are highly underused due to barriers in access, scheduling and resources.
METHODS


The present study protocol describes plans to evaluate use of interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints. If effective, this technology could supplement or replace in-person checks and revolutionise how government, industry and non-profits help parents install child restraints properly. Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians. We will randomly assign 1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians. Correctness of installation will be assessed using objective checklists, both following installation and again 4 months later.
CONCLUSION


We aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely, that such installations are not inferior to installation accuracy with live experts and that parents learn and retain information about child restraint installation.",2020,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","['American children aged 1-5 years', 'parents with child restraint installations', '1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians', 'parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians']","['interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],1476.0,0.13722,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Jennifer Morag', 'Initials': 'JM', 'LastName': 'MacKay', 'Affiliation': 'Safe Kids Worldwide, Washington, District of Columbia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Redden', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043463']
1154,31045231,Modulation of Adaptive Cognitive Control by Prefrontal High-Definition Transcranial Direct Current Stimulation in Older Adults.,"OBJECTIVE


Adaptive cognitive control frequently declines in advanced age. Because high-definition transcranial direct current stimulation (HD-tDCS) of the right dorsolateral prefrontal cortex (DLPFC) improved cognitive control in young adults, we investigated if this montage can also improve cognitive control in older individuals.
METHOD


In a double-blind, sham HD-tDCS controlled, cross-over design, 36 older participants received right DLPFC HD-tDCS during a visual flanker task. Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control. Biophysical modeling assessed the magnitude and distribution of induced current in older adults.
RESULTS


Active HD-tDCS enhanced CA in older adults. However, this positive behavioral effect was limited to CA in ER. Similar to results obtained in healthy young adults, current modeling analysis demonstrated focal current delivery to the DLPFC with sufficient magnitude of the induced current to modulate neural function in older adults.
DISCUSSION


This study confirms the effectiveness of HD-tDCS to modulate adaptive cognitive control in advanced age.",2019,Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control.,"['young adults', 'advanced age', 'older adults', 'older individuals', 'healthy young adults', '36 older participants received']","['adaptive cognitive control by prefrontal high definition transcranial direct current stimulation', 'transcranial direct current stimulation (HD-tDCS', 'right DLPFC HD-tDCS', 'HD-tDCS', 'Conflict adaptation (CA']",['response time (RT) and error rates (ER) assessed adaptive cognitive control'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",36.0,0.0364496,Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control.,"[{'ForeName': 'Oyetunde', 'Initials': 'O', 'LastName': 'Gbadeyan', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Steinhauser', 'Affiliation': 'Department of Psychology, Catholic University of Eichstätt-Ingolstadt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hunold', 'Affiliation': 'Institute of Biomedical Engineering and Informatics, Technical University Ilmenau, Germany.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haueisen', 'Affiliation': 'Institute of Biomedical Engineering and Informatics, Technical University Ilmenau, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz048']
1155,31729550,Low dose fentanyl infusion versus 24% oral sucrose for pain management during laser treatment for retinopathy of prematurity-an open label randomized clinical trial.,"To compare the efficacy of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief during laser for retinopathy of prematurity (ROP), we enrolled fifty-eight spontaneously breathing preterm infants undergoing laser. The preterm infants were randomized to either fentanyl infusion (1 mcg/kg/hr) or 24% oral sucrose (2 ml). We evaluated and compared the proportion of time spent crying during the procedure, salivary cortisol before and after the procedure, premature infant pain profile- revised (PIPP-R) scores during the procedure, apnoea during and after the procedure, need for mechanical ventilation, and feed intolerance and urinary retention 24 h after the procedure between the two groups. We found that the proportion of time spent crying during the procedure was significantly less in the fentanyl group [62.5% (50.7-74.2) vs 73.8% (55.6-83.4); P = 0.02]. Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)]. There was no difference in other outcomes between the two groups.Conclusion: During laser for ROP, low dose fentanyl infusion was found to be efficacious in reducing pain as compared with 24% sucrose.What is Known:• Preterm infants undergoing laser photocoagulation for ROP suffer significant amount of pain.• Standard of care for pain relief in infants undergoing laser therapy in developed countries is general anesthesia (GA) or combination of sedation, analgesia, and paralysis (SAP).What is New:• During laser photocoagulation for ROP, fentanyl infusion at low dose (1 mcg/kg/hr) is efficacious in reducing pain as compared to 24% oral sucrose.",2020,Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)].,"['infants undergoing', 'preterm infants', 'during laser for retinopathy of prematurity (ROP), we enrolled fifty-eight spontaneously breathing preterm infants undergoing laser', 'Known:• Preterm infants undergoing']","['fentanyl infusion versus 24% oral sucrose', 'fentanyl infusion (1 mcg/kg/hr) or 24% oral sucrose', 'laser therapy', 'fentanyl infusion and 24% oral sucrose', 'laser photocoagulation']","['premature infant pain profile- revised (PIPP-R) scores', 'optimal pain relief', 'pain', 'proportion of time spent crying', 'Average PIPP-R score', 'pain management']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1320752', 'cui_str': 'mcg/kg/hr'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",58.0,0.0523975,Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)].,"[{'ForeName': 'Amanpreet', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India. jeevasankar@gmail.com.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Parijat', 'Initials': 'P', 'LastName': 'Chandra', 'Affiliation': 'Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03514-5']
1156,31727664,"The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis.","INTRODUCTION


Rotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.
METHODS AND ANALYSIS


This Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.
ETHICS, REGISTRATION AND DISSEMINATION


Ethics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.
TRIAL REGISTRATION NUMBER


NCT02941107; Pre-results.",2019,"Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life.","['Australian Indigenous children aged 6 to <12 months old', 'Australian Indigenous infants']","['placebo', 'Rotarix/placebo', 'Rotarix rotavirus vaccine', 'oral human rotavirus vaccine (Rotarix, GlaxoSmithKline']","['change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification', 'protection against gastroenteritis', 'acute gastroenteritis/diarrhoea', 'seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre', 'serum anti-rotavirus IgA titre ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus (organism)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",,0.591793,"Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life.","[{'ForeName': 'Bianca Fleur', 'Initials': 'BF', 'LastName': 'Middleton', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia bianca.middleton@menzies.edu.au.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Waddington', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Danchin', 'Affiliation': 'Vaccine and Immunisation Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'McCallum', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gallagher', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin Univesity, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Kirkwood', 'Affiliation': 'Enteric and Diarrheal Diseases, Bill and Melinda Gates Foundation, Seattle, Washington, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Cunliffe', 'Affiliation': 'Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Marsh', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032549']
1157,30935872,"Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial.","BACKGROUND


Glucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both.
METHODS


We did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6-10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565.
FINDINGS


Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5-45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group.
INTERPRETATION


Closed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital.
FUNDING


Diabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes.",2019,"One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions.","['patients who require nutritional support in hospital', 'Patients recruited from non-critical care surgical and medical wards', 'adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy', 'inpatients receiving enteral or parenteral nutrition or both', 'inpatients receiving nutritional support', 'Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22', 'patients receiving nutritional support in hospital']","['conventional subcutaneous insulin therapy', 'computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice', 'Fully closed-loop insulin delivery']","['severe hypoglycaemia or hyperglycaemia with ketonaemia', 'proportion of time that sensor glucose', 'proportion of time that sensor glucose concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0235430', 'cui_str': 'Ketoacidemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",90.0,0.186561,"One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions.","[{'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Martignoni', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wertli', 'Affiliation': 'Department of General Internal Medicine, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30061-0']
1158,31583436,"A phase I delayed-start, randomized and pharmacodynamic study of metformin and chemotherapy in patients with solid tumors.","PURPOSE


Metformin activates AMP-related pathways leading to inactivation of mammalian target of rapamycin (mTOR) and suppression of its downstream effectors, crucial for cancer growth. Epidemiologic studies showed a reduced incidence and improved survival in cancer patients. We conducted a prospective phase I study to assess the safety of metformin in combination with chemotherapy in patients with solid tumors.
METHODS


We conducted a delayed-start randomized trial of non-diabetic patients in two stages. In Stage 1, we randomized patients to two arms: concurrent arm (metformin with chemo) vs. delayed arm (chemo alone). In Stage 2, patients in delayed arm were crossed over to receive metformin. Patients received metformin 500 mg twice daily with chemotherapy to define dose-limiting toxicities (DLTs) in both stages. Secondary endpoints assessed adverse events (AEs) and response rates. Translational correlates included effects of metformin on expression and phosphorylation of 5' adenosine monophosphate-activated protein kinase (AMPK) by western blot in PBMCs.
RESULTS


A total of 100 patients were enrolled (51 in delayed arm vs. 49 concurrent arm). Rate of DLTs in patients receiving metformin with chemotherapy was 6.1% vs. 7.8% in patients receiving chemotherapy alone. DLTs seen with addition of metformin included those associated with established chemo adverse events. No lactic acidosis or hypoglycemia occurred. Restaging showed stable disease in 46% at cessation of metformin. 28% of patients with measurable tumor markers showed improvement. AMPK phosphorylation showed a four- to sixfold increase in AMPK phosphorylation after metformin.
CONCLUSIONS


This is the largest phase I study of metformin combined with chemotherapy, which suggests that metformin can be given safely with chemotherapy, and offers a platform for future studies. Post-metformin increase in AMPK phosphorylation may potentially explain lack of disease progression in nearly half of our patients.
FUNDING


UL1 TR001064.
CLINICAL TRIAL INFORMATION


NCT01442870.",2019,No lactic acidosis or hypoglycemia occurred.,"['cancer patients', 'patients with solid tumors', '100 patients were enrolled (51 in delayed arm vs. 49 concurrent arm', 'non-diabetic patients in two stages']","['metformin with chemotherapy', 'metformin combined with chemotherapy', 'metformin', 'chemotherapy', 'metformin 500\xa0mg twice daily with chemotherapy', 'concurrent arm (metformin with chemo) vs. delayed arm (chemo alone', 'metformin and chemotherapy']","['Rate of DLTs', 'survival', 'lactic acidosis or hypoglycemia', 'AMPK phosphorylation', 'adverse events (AEs) and response rates']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.0465807,No lactic acidosis or hypoglycemia occurred.,"[{'ForeName': 'Mohammad Wasif', 'Initials': 'MW', 'LastName': 'Saif', 'Affiliation': 'Northwell Health Cancer Institute, 1111 Marcus Avenue, 2nd Floor, Lake Success, NY, 11042, USA. wsaif@northwell.edu.'}, {'ForeName': 'Shrikar', 'Initials': 'S', 'LastName': 'Rajagopal', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Caplain', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Grimm', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Serebrennikova', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Tsichlis', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martell', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03967-3']
1159,31628791,Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial.,"BACKGROUND


Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs.
OBJECTIVE


This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions.
METHODS


This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form.
RESULTS


The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=-.39; P=.21). Therapeutic alliance increased over time in both conditions (F 2,90 =16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F 1,91 =0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=-.12; t 114 =-2.656; P=.01) and an increase in mental well-being (B=.23; t 113 =2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t 113 =2.261; P=.03).
CONCLUSIONS


A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513.",2019,"Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions.","['Distressed Cancer Patients', 'distressed cancer patients']","['Mindfulness-based cognitive therapy (MBCT', 'therapist assistance', 'Internet-based MBCT (eMBCT', 'Internet-Based Mindfulness-Based Cognitive Therapy', 'MBCT or eMBCT']","['Therapeutic alliance', 'strength of therapeutic alliance', 'psychological distress', 'strength of early alliance', 'strength of early therapeutic alliance', 'therapeutic alliance', 'psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0638798,"Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions.","[{'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Bisseling', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schellekens', 'Affiliation': 'Helen Dowling Institute, Centre for Psycho-Oncology, Scientific Research Department, Bilthoven, Netherlands.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Compen', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van der Lee', 'Affiliation': 'Helen Dowling Institute, Centre for Psycho-Oncology, Scientific Research Department, Bilthoven, Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Speckens', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/14065']
1160,32410703,Urinary angiotensinogen as a surrogate marker predicting the antiproteinuric effects of angiotensin receptor blockers in patients with overt proteinuria: a multicenter prospective study.,"BACKGROUND


Although urinary angiotensinogen (AGT) and renin reflect intrarenal renin-angiotensin system activity and are enhanced in proteinuric chronic kidney disease, the clinical value of urinary AGT and renin levels during antiproteinuric treatment has yet to be determined. We investigated the clinical usefulness of initial urinary AGT or renin to determine the antiproteinuric effects of angiotensin receptor blockers (ARBs).
METHODS


This multicenter, prospective, single-arm study included 205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR] ≥ 1 mg/mg) enrolled between April 2009 and December 2011. All patients were treated with valsartan. The urinary AGT/creatinine ratio (uAGT/Cr) was measured at the baseline and 24 weeks, and the renin/creatinine ratio (uR/Cr) was measured at the baseline. Fifty-six patients were followed-up for 5 years.
RESULTS


The mean age was 47.6 years and 51.2% were male. The mean uPCR was 2.32 mg/mg and the mean eGFR was 63.2 mL/min/1.73m 2 . Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus were associated with proteinuria decrement (decrease in uPCR ≥1 mg/mg). Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013). Among the 56 patients followed-up for 5 years, Δln(uAGT/Cr) at 24 weeks was an independent predictor for uPCR < 1 mg/mg at 5 years (OR 0.379, 95% CI, 0.20-0.715, P = 0.003).
CONCLUSIONS


Our study demonstrates the potential role of both baseline urinary AGT and changes in urinary AGT during the initial 24 weeks as surrogate markers predicting the antiproteinuric effects of ARBs in patients with overt proteinuria.",2020,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","['205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR]\u2009≥\u20091\u2009mg/mg) enrolled between April 2009 and December 2011', 'patients with overt proteinuria', 'Fifty-six patients were followed-up for 5\u2009years', 'The mean age was 47.6\u2009years and 51.2% were male']","['valsartan', 'angiotensin receptor blockers', 'angiotensin receptor blockers (ARBs']","['mean uPCR', 'urinary AGT/creatinine ratio (uAGT/Cr', 'proteinuria decrement', 'Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus', 'renin/creatinine ratio (uR/Cr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0428627', 'cui_str': 'Protein/creatinine ratio measurement'}, {'cui': 'C1319635', 'cui_str': 'mg/mg'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003017', 'cui_str': 'Angiotensinogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035094', 'cui_str': 'Renin'}]",205.0,0.0182478,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","[{'ForeName': 'Junseok', 'Initials': 'J', 'LastName': 'Jeon', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Do Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Hye Ryoun', 'Initials': 'HR', 'LastName': 'Jang', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. shinehr@gmail.com.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Wooseong', 'Initials': 'W', 'LastName': 'Huh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Hye-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Yoon-Goo', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}]",BMC nephrology,['10.1186/s12882-020-01825-6']
1161,31706300,Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies.,"BACKGROUND


Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778).
METHODS


In DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C ≥ 100 mg/dL; n = 413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C ≥ 70 mg/dL; n = 441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin < 9% (DM-DYSLIPIDEMIA) or < 10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was ≥ 70 mg/dL (DM-INSULIN) or non-HDL-C was ≥ 100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these studies.
RESULTS


This analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C < 100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA]; 65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB < 80 mg/dL (75.1% alirocumab/35.4% UC and 76.8% alirocumab/24.8% placebo, respectively) versus control at week 24 (all P < 0.0001). In pooling these studies, 66.4% (alirocumab) and 67.0% (control) of individuals reported treatment-emergent adverse events. The adverse event pattern was similar with alirocumab versus controls.
CONCLUSIONS


Among individuals with T2DM and ASCVD who had high non-HDL-C/LDL-C levels despite maximally tolerated statin, alirocumab significantly reduced atherogenic cholesterol and LDL-PN versus control. Alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov. NCT02642159. Registered 30 December 2015 and Clinicaltrials.gov. NCT02585778. Registered 23 October 2015.",2019,"At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control.","['patients with ASCVD from these studies', '142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively', 'individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease', '70\xa0mg/dL; n\u2009=\u2009441', 'individuals with T2DM and mixed dyslipidemia (non-HDL-C\u2009≥', 'individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778', '100\xa0mg/dL; n\u2009=\u2009413', 'Study participants also had a glycated hemoglobin\u2009<\u20099% (DM-DYSLIPIDEMIA) or\u2009<\u200910% (DM-INSULIN']","['alirocumab', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab', 'Alirocumab', 'alirocumab 75\xa0mg Q2W or placebo', 'Alirocumab therapy', 'open-label alirocumab']","['atherogenic cholesterol and LDL-PN', 'tolerated', 'LDL-C, non-HDL-C, ApoB, and LDL-PN', 'efficacy and safety', 'Lipid reductions and safety', 'adverse event pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0342257', 'cui_str': 'Diabetes Complications'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.292838,"At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control.","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College, Kensington, London, SW7 2AZ, UK. k.ray@imperial.ac.uk.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""l'institut du thorax, Department of Endocrinology, CHU Nantes, INSERM, 1413, Nantes, France.""}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Department of Clinical Endocrinology and Nutrition (IBIMA), Hospital Virgen de la Victoria, University of Málaga, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Málaga, Spain.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Domenger', 'Affiliation': 'Sanofi, Gentilly, France.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Biostatistics and Programming Department, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mandel', 'Affiliation': 'IviData Stats, Levallois-Perret, France.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Samuel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, NY, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}]",Cardiovascular diabetology,['10.1186/s12933-019-0951-9']
1162,31033228,"Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis.","OBJECTIVE


To evaluate the effects of a low-load resistance training program associated with partial blood-flow restriction in patients with rheumatoid arthritis (RA).
METHODS


Forty-eight women with RA were randomized into 1 of 3 groups: high-load resistance training (HL-RT; 70% 1 repetition maximum [1RM]), low-load resistance training (30% 1RM) with partial blood-flow restriction training (BFRT), and a control group. Patients completed a 12-week supervised training program and were assessed for lower-extremity 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], and Health Assessment Questionnaire [HAQ]), and quality of life (Short Form 36 health survey [SF-36]) at baseline and after the intervention.
RESULTS


BFRT and HL-RT were similarly effective in increasing maximum dynamic strength in both leg press (22.8% and 24.2%, respectively; P < 0.0001 for all) and knee extension (19.7% and 23.8%, respectively; P < 0.0001 for all). Quadriceps CSA was also significantly increased in both BFRT and HL-RT (9.5% and 10.8%, respectively; P < 0.0001 for all). Comparable improvements in TST (11.2% and 14.7%; P < 0.0001 for all) and TUG (-6.8% [P < 0.0053] and -8.7% [P < 0.0001]) were also observed in BFRT and HL-RT, respectively. Improvements in both groups were significantly greater than those of the control group (P < 0.05 for all). SF-36 role physical and bodily pain and HAQ scores were improved only in BFRT (45.7%, 22.5%, and -55.9%, respectively; P < 0.05 for all). HL-RT resulted in 1 case of withdrawal and several cases of exercise-induced pain, which did not occur in BFRT.
CONCLUSION


BFRT was effective in improving muscle strength, mass, function, and health-related quality of life in patients with RA, emerging as a viable therapeutic modality in RA management.",2020,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","['Forty-eight women with RA', 'patients with rheumatoid arthritis (RA', 'women with rheumatoid arthritis']","['low-load resistance training program', 'high-load resistance training (HL-RT: 70% one repetition maximum [1RM]); low-load resistance training (30% 1RM) with partial blood flow restriction (BFRT) and control group', 'supervised training program', 'Low-load resistance training with blood flow restriction', 'BFRT']","['knee extension', 'SF-36 role physical, bodily pain and HAQ scores', 'Quadriceps CSA', 'muscle strength, mass, function and health-related quality of life', 'partial blood flow restriction', 'maximal dynamic strength', 'TUG', 'lower-limb 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], Health Assessment Questionnaire [HAQ]) and quality of life (Short Form Health Survey [SF-36', 'TST']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",48.0,0.0203149,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","[{'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Ferraz', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ceci O', 'Initials': 'CO', 'LastName': 'Kurimori', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lissiane K', 'Initials': 'LK', 'LastName': 'Guedes', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Lima', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}]",Arthritis care & research,['10.1002/acr.23911']
1163,30862667,A Human TRPA1-Specific Pain Model.,"The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances. However, TRPA1 species differences are substantial and limit translational research. TRPA1 agonists tested previously in humans also have other targets. Therefore, the sensation generated by isolated TRPA1 activation in humans is unknown. The availability of 2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N- (3-methoxypropyl)-acetamide (JT010), a potent and specific TRPA1 agonist, allowed us to explore this issue. To corroborate the specificity of JT010, it was investigated whether the TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime (A-967079) abolishes JT010-elicited pain. Sixteen healthy volunteers of both sexes rated pain due to intraepidermal injections of different concentrations and combinations of the substances. The study design was a double-blind crossover study. All subjects received all types of injections, including a placebo without substances. Injections of the TRPA1 agonist dose-dependently caused pain with a half-maximal effective concentration of 0.31 μm Coinjection of A-967079 dose-dependently reduced and at a high concentration abolished JT010-induced pain. Quantification of JT010 by HPLC showed that a substantial part is adsorbed when in contact with polypropylene surfaces, but that this was overcome by handling in glass vials and injection using glass syringes. Isolated TRPA1 activation in humans causes pain. Thus, intradermal JT010 injection can serve as a tool to validate new TRPA1 antagonists concerning target engagement. More importantly, TRPA1-specific tools allow quantification of the TRPA1-dependent component in physiology and pathophysiology. SIGNIFICANCE STATEMENT  This study showed that activation of the ion channel transient receptor potential ankyrin 1 (TRPA1) alone indeed suffices to elicit pain in humans, independent of other receptors previously found to be involved in pain generation. The newly established TRPA1-specific pain model allows different applications. First, it can be tested whether diseases are associated with compromised or exaggerated TRPA1-dependent painful sensations in the skin. Second, it can be investigated whether a new, possibly systemically applied drug directed against TRPA1 engages its target in humans. Further, the general possibility of quantitative inhibition of TRPA1 allows identification of the TRPA1-dependent disease component, given that the substance reaches its target. This contributes to a better understanding of pathophysiology, can lay the basis for new therapeutic approaches, and can bridge the gap between preclinical research and clinical trials.",2019,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,['Sixteen healthy volunteers of both sexes rated pain'],"['2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N', 'placebo without substances', '3-methoxypropyl)-acetamide (JT010', 'TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime']",['pain'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0050423', 'cui_str': 'acetamide'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0030020', 'cui_str': 'Hydroxyimino Compounds'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",16.0,0.0439185,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Heber', 'Affiliation': 'Institutes of Physiology, stefan.heber@meduniwien.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gold-Binder', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Cosmin I', 'Initials': 'CI', 'LastName': 'Ciotu', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Witek', 'Affiliation': 'Pharmacology, Center for Physiology and Pharmacology, and.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Ninidze', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kress', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael J M', 'Initials': 'MJM', 'LastName': 'Fischer', 'Affiliation': 'Institutes of Physiology.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3048-18.2019']
1164,29390862,Financial Incentives for Chronic Disease Management: Results and Limitations of 2 Randomized Clinical Trials With New York Medicaid Patients.,"PURPOSE


To identify whether financial incentives promote improved disease management in Medicaid recipients diagnosed with hypertension or diabetes, respectively.
DESIGN


Four-group, multicenter, randomized clinical trials.
SETTING AND PARTICIPANTS


Between 2013 and 2016, New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959).
INTERVENTION


Participants in each 6-month trial were randomly assigned to 1 of 4 arms: (1) process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A 1c  (HbA 1c ; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives).
MEASURES


Systolic blood pressure (hypertension) and HbA 1c  (diabetes) levels, primary care visits, and medication prescription refills. Analysis and Results: At 6 months, there were no statistically significant differences between intervention arms and the control arm in the change in systolic blood pressure, P = .531. Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939. The majority of participants had acceptable systolic blood pressure (<140 mm Hg) or blood glucose (<8.0%) levels at baseline and throughout the study.
CONCLUSION


Financial incentives-regardless of whether they were delivered based on disease-relevant outcomes, process activities, or a combination of the two-have a negligible impact on health outcomes for Medicaid recipients diagnosed with either hypertension or diabetes in 2 studies in which, among other design and operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.",2018,"Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939.","['Medicaid recipients diagnosed with hypertension or diabetes, respectively', 'Between 2013 and 2016', 'New York Medicaid Patients', 'Medicaid recipients diagnosed with either hypertension or diabetes', 'New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959']","['process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A 1c  (HbA 1c ; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives']","['blood glucose', 'acceptable systolic blood pressure', 'systolic blood pressure', 'Systolic blood pressure (hypertension) and HbA 1c  (diabetes) levels, primary care visits, and medication prescription refills', 'blood glucose control (HbA 1c ']","[{'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}]","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0587272,"Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939.","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'VanEpps', 'Affiliation': '1 David Eccles School of Business, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': '2 Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Villamil', 'Affiliation': '3 New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Saulsgiver', 'Affiliation': '4 Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': '4 Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jo-Yu', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': '3 New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Matson', 'Affiliation': '3 New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anarella', 'Affiliation': '6 Consultant, Albany, NY, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roohan', 'Affiliation': '7 MVP Health Care, Schenectady, NY, USA.'}, {'ForeName': 'Foster', 'Initials': 'F', 'LastName': 'Gesten', 'Affiliation': '3 New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': '4 Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117117753986']
1165,31725142,Does tranexamic acid reduce mortality in women with postpartum hemorrhage?,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).",2019,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).",['women with postpartum hemorrhage'],['tranexamic acid'],['maternal mortality'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}]",,0.275637,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dresang', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kredit', 'Affiliation': 'University of Wisconsin Department of Family Medicine and Community Health, Madison, USA.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Vellardita', 'Affiliation': 'Ebling Library, University of Wisconsin, Madison, USA.'}]",The Journal of family practice,[]
1166,31647470,Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability Study.,"BACKGROUND


Active participant monitoring of adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety postmarketing. Vaxtracker, an online tool used to monitor vaccine safety, has successfully demonstrated its usefulness in postmarketing surveillance of newly introduced childhood vaccines. However, its use in older participants, or for monitoring patients participating in large clinical trials, has not been evaluated.
OBJECTIVE


The objective of this study was to monitor AEFIs in older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial, and to evaluate the usefulness and effectiveness of Vaxtracker in this research setting.
METHODS


AUSPICE is a multicenter, randomized, placebo-controlled, double-blinded trial in which participants aged 55 to 61 years were given either the pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo. Vaxtracker was used to monitor AEFIs in participants in either treatment arm through the administration of two online questionnaires. A link to each questionnaire was sent to participants via email or short message service (SMS) text message 7 and 28 days following vaccination. Data were collated and analyzed in near-real time to identify any possible safety signals indicating problems with the vaccine or placebo.
RESULTS


All 4725 AUSPICE participants were enrolled in Vaxtracker. Participant response rates for the first and final survey were 96.47% (n=4558) and 96.65% (n=4525), respectively. The online survey was completed by 90.23% (4083/4525) of Vaxtracker participants within 3 days of receiving the link. AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination. Dominant symptoms for vaccine and placebo recipients were pain at the injection site (587/2340, 25.09%) and fatigue (103/2332, 4.42%), respectively. Females were more likely to report symptoms following vaccination with 23vPPV compared with males (433/1138, 38.05% versus 372/1202, 30.95%; P<.001).
CONCLUSIONS


Vaxtracker is an effective tool for monitoring AEFIs in the 55 to 61 years age group. Participant response rates were high for both surveys, in both treatment arms and for each method of sending the survey. This study indicates that administration of 23vPPV was well-tolerated in this cohort. Vaxtracker has successfully demonstrated its application in the monitoring of adverse events in near-real time following vaccination in people participating in a national clinical trial.
TRIAL REGISTRATION


Australian New Zealand Trial Registry Number (ACTRN) 12615000536561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368506.",2019,AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination.,"['All 4725 AUSPICE participants were enrolled in Vaxtracker', 'older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial', 'participants aged 55 to 61 years', 'older participants, or for monitoring patients participating in large clinical trials']","['placebo', 'immunization (AEFI', 'pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo', '23vPPV']","['AEFIs', 'Participant response rates', 'fatigue']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0305065', 'cui_str': 'Pneumococcal Polysaccharide Vaccine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.671419,AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination.,"[{'ForeName': 'Sally-Anne', 'Initials': 'SA', 'LastName': 'Munnoch', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cashman', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Roseanne', 'Initials': 'R', 'LastName': 'Peel', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Hure', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Durrheim', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}]",Journal of medical Internet research,['10.2196/14791']
1167,30765503,The Electronic Asthma Management System (eAMS) improves primary care asthma management.,"A high prevalence of suboptimal asthma control is attributable to known evidence-practice gaps. We developed a computerised clinical decision support system (the Electronic Asthma Management System (eAMS)) to address major care gaps and sought to measure its impact on care in adults with asthma.This was a 2-year interrupted time-series study of usual care (year 1)  versus  eAMS (year 2) at three Canadian primary care sites. We included asthma patients aged ≥16 years receiving an asthma medication within the last 12 months. The eAMS consisted of a touch tablet patient questionnaire completed in the waiting room, with real-time data processing producing electronic medical record-integrated clinician decision support.Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)). Time-series analysis indicated a 30.5% increase in physician visits with action plan delivery with the intervention (p<0.0001). Assessment of asthma control level increased from 173 out of 3497 (4.9%) to 849 out of 3062 (27.7%) eligible visits (adjusted OR 8.62 (95% CI 5.14-12.45)). Clinicians escalated controller therapy in 108 out of 3422 (3.2%) baseline visits  versus  126 out of 3240 (3.9%) intervention visits (p=0.12). At baseline, a short-acting β-agonist alone was added in 62 visits and a controller added in 54 visits; with the intervention, this occurred in 33 and 229 visits, respectively (p<0.001).The eAMS improved asthma quality of care in real-world primary care settings. Strategies to further increase clinician uptake and a randomised controlled trial to assess impact on patient outcomes are now required.",2019,Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)).,"['adults with asthma', 'asthma patients aged ≥16\u2005years receiving an asthma medication within the last 12\u2005months']","['usual care (year 1)  versus  eAMS', 'computerised clinical decision support system (the Electronic Asthma Management System (eAMS', 'Electronic Asthma Management System (eAMS']","['physician visits', 'asthma quality of care', 'asthma control level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3497.0,0.0463128,Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)).,"[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada guptas@smh.ca.""}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Dept of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Dept of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Health Quality Innovation Collaborative, Brampton, ON, Canada.'}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'Boulet', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Universite Laval, Québec, QC, Canada.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Kaplan', 'Affiliation': 'Family Physician Airways Group of Canada, Edmonton, AB, Canada.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Lebovic', 'Affiliation': ""Applied Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mamdani', 'Affiliation': ""Li Ka Shing Centre for Healthcare Analytics Research and Training (LKS-CHART), Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Straus', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}]",The European respiratory journal,['10.1183/13993003.02241-2018']
1168,31033903,Interactive Virtual Reality Reduces Quadriceps Pain during High-Intensity Cycling.,"PURPOSE


Brief, high-intensity cycling is popular because physiological benefits accrue with a short workout time, but burning pain in the quadriceps is a potential barrier to engaging in this type of exercise. Virtual reality (VR) can temporarily decrease pain, but its effect on muscle pain during high-intensity exercise is unknown. The primary purpose of this experiment was to test whether adding interactive VR (I-VR) to high-intensity cycling could reduce quadriceps pain or improve performance.
METHODS


Ninety-four adults who were physically active in their leisure time and age 18 to 29 yr completed three 30-s sprint interval cycling trials at a high resistance (0.085- and 0.075-kg resistance to the flywheel per kilogram body weight for men and women, respectively). In this randomized between-subject experiment, participants cycled while wearing a head-mounted display and viewing either (i) a dynamically changing cityscape perceived as interactively cycling through a virtual city (I-VR group) or (ii) a static picture of the cityscape with instructions to mentally imagine cycling through that city (static VR/motor imagery control group).
RESULTS


Sphericity-adjusted 2 × 3 (group-time) ANOVA revealed a significant group-time interaction (F = 4.568; df = 1.499, 133.301; ηp = 0.047, P = 0.021) for pain intensity. With I-VR, pain intensities were 13.3% (mean, 4.60 vs 5.31; d = 0.28) and 11.8% (mean, 5.68 vs 6.44; d = 0.27) lower at sprint trials 2 and 3, respectively. The group-time interaction (P = 0.412) was not significant for total work.
CONCLUSION


Compared with a static VR/motor imagery control condition, I-VR during brief, high-intensity, fatigue-inducing leg cycling attenuates quadriceps pain intensity without reducing performance.",2019,"With I-VR, pain intensity was 13.3% (M = 4.60 vs. 5.31, d = .28) and 11.8% (M = 5.68 vs. 6.44, d = .27) lower at sprint trials 2 and 3, respectively.","['94 adults, physically active in their leisure time and aged 18 to 29, completed three 30-sec sprint interval cycling trials at a high resistance (0.085 and 0.075 kilograms resistance to the flywheel per kilogram body weight for males and females, respectively']","['participants cycled while wearing a head-mounted display and viewing either (i) a dynamically changing cityscape perceived as interactively cycling through a virtual city (I-VR group) or (ii) a static picture of the cityscape with instructions to mentally imagine cycling through that city (static VR/motor imagery control group', 'static VR/motor imagery control condition, interactive VR during brief, high intensity, fatigue-inducing leg cycling', 'Interactive Virtual Reality', 'interactive VR (I-VR']","['quadriceps pain or improve performance', 'Quadriceps Pain', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",94.0,0.0753903,"With I-VR, pain intensity was 13.3% (M = 4.60 vs. 5.31, d = .28) and 11.8% (M = 5.68 vs. 6.44, d = .27) lower at sprint trials 2 and 3, respectively.","[{'ForeName': 'Carly L A', 'Initials': 'CLA', 'LastName': 'Wender', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA.'}, {'ForeName': 'Sun Joo', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002016']
1169,30792342,Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial.,"We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI -0.89-5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19-10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.",2019,No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care.,"['aged ≥40\u2005years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD', 'primary care', '272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase', '43 general practices in Australia', 'Adults with a history of smoking and/or COPD']","['Interdisciplinary COPD intervention', 'smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase', 'interdisciplinary, primary care-based model of care']","['SGRQ', ""changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function"", 'change in CAT, dyspnoea, smoking abstinence or lung function']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]",272.0,0.102985,No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care.,"[{'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Abramson', 'Affiliation': 'Dept of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Southern Academic Primary Care Research Unit, Dept of General Practice, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Discipline of Physiotherapy, La Trobe University, Alfred Health, and Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'The Nossal Institute for Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Eustace', 'Affiliation': 'Eastern Melbourne PHN (EMPHN), Melbourne, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Dept of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Lung Foundation Australia (LFA), Milton, Australia.'}, {'ForeName': 'Narelle S', 'Initials': 'NS', 'LastName': 'Cox', 'Affiliation': 'Discipline of Physiotherapy, La Trobe University and Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia johnson.george@monash.edu.'}]",The European respiratory journal,['10.1183/13993003.01530-2018']
1170,30285092,Strength Endurance Training but Not Intensive Strength Training Reduces Senescence-Prone T Cells in Peripheral Blood in Community-Dwelling Elderly Women.,"Aging is characterized by a progressive decline in immune function known as immunosenescence. Although the causes of immunosenescence are likely to be multifactorial, an age-associated accumulation of senescent T cells and decreased naive T-cell repertoire are key contributors to the phenomenon. On the other hand, there is a growing consensus that physical exercise may improve immune response in aging. However, the optimum training modality required to obtain beneficial adaptations in older subjects is lacking. Therefore, we aimed to investigate the effects of exercise modality on T-cell phenotypes in older women. A total of 100 women (aged ≥ 65 years) were randomized to either intensive strength training (80% of one-repetition maximum ), strength endurance training (40% one-repetition maximum), or control (stretching exercise) for 2-3 times per week during 6 weeks. The T-cell percentages and absolute counts were determined using flow cytometry and a hematology analyzer. C-reactive protein was measured using immunonephelometry. We report for the first time that 6 weeks of strength endurance training significantly decreased the basal percentage and absolute counts of senescence-prone T cells, which was positively related to the number of training sessions performed. Conceivably, training protocols with many repetitions-at a sufficiently high external resistance-might assist the reduction of senescence-prone T cells in older women.",2019,"We report for the first time that 6 weeks of SET significantly decreased the basal percentage and absolute counts of senescence-prone T-cells, which was positively related to the number of training sessions performed.","['community-dwelling elderly women', '100 women (aged ≥65 years', 'older women', 'older subjects']","['intensive strength training (80% of one-repetition maximum (1RM)), strength endurance training (SET, 40% 1RM), or control (stretching exercise', 'exercise modality', 'physical exercise', 'intensive strength training', 'Strength endurance training']","['basal percentage and absolute counts of senescence-prone T-cells', 'C-reactive protein']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0231337', 'cui_str': 'Senescence'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",100.0,0.0185678,"We report for the first time that 6 weeks of SET significantly decreased the basal percentage and absolute counts of senescence-prone T-cells, which was positively related to the number of training sessions performed.","[{'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Cao Dinh', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Njemini', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Oscar Okwudiri', 'Initials': 'OO', 'LastName': 'Onyema', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Beyer', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Keliane', 'Initials': 'K', 'LastName': 'Liberman', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'De Dobbeleer', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Renmans', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Vander Meeren', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Jochmans', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Delaere', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Knoop', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly229']
1171,31002578,Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.,"PURPOSE


To evaluate the impact of two different intraperitoneal (IP) chemotherapy regimens on progression-free survival (PFS) among women with newly diagnosed advanced ovarian carcinoma.
METHODS


Eligible patients were randomly assigned to six cycles of IV paclitaxel 80 mg/m 2  once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2  once per week with IP carboplatin area under the curve 6 (IP carboplatin) versus once every 3 weeks IV paclitaxel 135 mg/m 2  over 3 hours day 1, IP cisplatin 75 mg/m 2  day 2, and IP paclitaxel 60 mg/m 2  day 8 (IP cisplatin). All participants received bevacizumab 15 mg/kg IV every 3 weeks in cycles 2 to 22.
RESULTS


A total of 1,560 participants were enrolled and had 84.8 months of follow-up. The median PFS duration was 24.9 months in the IV carboplatin arm, 27.4 months in the IP carboplatin arm, and 26.2 months in the IP cisplatin arm. For the subgroup of 1,380 patients with stage II/III and residual disease of 1 cm or less, median PFS was 26.9 (IV-carboplatin), 28.7 (IP-carboplatin), and 27.8 months (IP cisplatin), respectively. Median PFS for patients with stage II/III and no residual disease was 35.9, 38.8, and 35.5 months, respectively. Median overall survival for all enrolled was 75.5, 78.9, and 72.9 months, respectively, and median overall survival for stage II/III with no gross residual disease was 98.8 months, 104.8 months, and not reached. Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores (Gynecologic Oncology Group) were similar for all arms, but the mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores during chemotherapy were statistically worse in the IP cisplatin arm.
CONCLUSION


Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.",2019,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","['1,560 participants were enrolled and had 84.8 months of follow-up', 'women with newly diagnosed advanced ovarian carcinoma', 'Advanced Ovarian Carcinoma', 'Eligible patients', '1,380 patients with stage II/III and residual disease of 1 cm or less']","['intraperitoneal (IP) chemotherapy regimens', 'bevacizumab', 'IV paclitaxel 80 mg/m 2  once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2  once per week with IP carboplatin area under the curve 6 (IP carboplatin', 'Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab', 'paclitaxel 135 mg/m 2  over 3 hours day 1, IP cisplatin 75 mg/m 2  day 2, and IP paclitaxel', 'IP cisplatin']","['Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores', 'progression-free survival (PFS', 'mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores', 'median PFS duration', 'duration of PFS', 'median overall survival', 'median PFS', 'Median overall survival', 'Median PFS']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029925'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1560.0,0.234568,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': '4 The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '5 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': '6 Saitama Medical University International Medical Center, Hidaka-Shi, Japan.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': '7 The University of Arizona Cancer Center, Tucson, AZ.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '8 The University of Arizona, Tucson, AZ.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': '9 The Ohio State University, Columbus, OH.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': '10 Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': '11 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Davidson', 'Affiliation': '12 University of Colorado, Aurora, CO.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Gray', 'Affiliation': '13 University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Rose', 'Affiliation': '14 Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': '15 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tashanna', 'Initials': 'T', 'LastName': 'Myers', 'Affiliation': '16 University of Connecticut, Storrs, CT.'}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': '17 Duke University Health System, Durham, NC.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': '18 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01568']
1172,31593541,Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial.,"BACKGROUND


The beneficial effects of physical activity (PA) for older adults are well known. However, few older adults reach the health guideline of 150 min per week of moderate-to-vigorous PA (MVPA). Electronic health (eHealth) interventions are effective in increasing PA levels in older adults in the short term but, rarely, intermediate-term effects after a period without the support of a website or an app have been examined. Furthermore, current theory-based interventions focus mainly on preintentional determinants, although postintentional determinants should also be included to increase the likelihood of successful behavior change.
OBJECTIVE


This study aimed to investigate the effect of the theory-based eHealth intervention, MyPlan 2.0, focusing on pre- and postintentional determinants on both accelerometer-based and self-reported PA levels in older Belgian adults in the short and intermediate term.
METHODS


This study was a randomized controlled trial with three data collection points: baseline (N=72), post (five weeks after baseline; N=65), and follow-up (three months after baseline; N=65). The study took place in Ghent, and older adults (aged ≥65 years) were recruited through a combination of random and convenience sampling. At all the time points, participants were visited by the research team. Self-reported domain-specific PA was assessed using the International Physical Activity Questionnaire, and accelerometers were used to objectively assess PA. Participants in the intervention group got access to the eHealth intervention, MyPlan 2.0, and used it independently for five consecutive weeks after baseline. MyPlan 2.0 was based on the self-regulatory theory and focused on both pre- and postintentional processes to increase PA. Multilevel mixed-models repeated measures analyses were performed in R (R Foundation for Statistical Computing).
RESULTS


Significant (borderline) positive intervention effects were found for accelerometer-based MVPA (baseline-follow-up: intervention group +5 min per day and control group -5 min per day; P=.07) and for accelerometer-based total PA (baseline-post: intervention group +20 min per day and control group -24 min per day; P=.05). MyPlan 2.0 was also effective in increasing self-reported PA, mainly in the intermediate term. A positive intermediate-term intervention effect was found for leisure-time vigorous PA (P=.02), moderate household-related PA (P=.01), and moderate PA in the garden (P=.04). Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
CONCLUSIONS


The findings suggest that theory-based eHealth interventions focusing on pre- and postintentional determinants have the potential for behavior change in older adults. If future studies including larger samples and long-term follow-up can confirm and clarify these findings, researchers and practitioners should be encouraged to use a self-regulation perspective for eHealth intervention development.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03194334; https://clinicaltrials.gov/ct2/show/NCT03783611.",2019,"Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
","['older Belgian adults in the short and intermediate term', 'older adults (aged ≥65 years', 'Older Belgian Adults', 'older adults']","['Electronic health (eHealth) interventions', 'physical activity (PA', 'MyPlan']","['leisure-time vigorous PA', 'leisure-time moderate PA', 'PA levels', 'Physical Activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",150.0,0.0344077,"Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
","[{'ForeName': 'Delfien', 'Initials': 'D', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Poppe', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Bourdeaudhuij', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Freja', 'Initials': 'F', 'LastName': 'Gheysen', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}]",Journal of medical Internet research,['10.2196/13219']
1173,31651403,Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial.,"BACKGROUND


We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression.
OBJECTIVE


The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up.
METHODS


Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3).
RESULTS


At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group.
CONCLUSIONS


Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists' concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.",2019,"At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group.",['229 patients'],['Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy'],"['lower symptom load regarding depressive symptoms', 'quality of life (d=0.43) and self-esteem', 'Beck Depression Inventory-II (BDI-II) improved over time', 'Course of Depressive Symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",229.0,0.205519,"At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Zwerenz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Baumgarten', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': ""Institute for Teachers' Health, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Tibubos', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Clinic for Psychosomatic Medicine, Rhön-Klinikum AG, Bad Neustadt/ Saale, Germany.'}, {'ForeName': 'Rudolf J', 'Initials': 'RJ', 'LastName': 'Knickenberg', 'Affiliation': 'Clinic for Psychosomatic Medicine, Rhön-Klinikum AG, Bad Neustadt/ Saale, Germany.'}, {'ForeName': 'Manfred E', 'Initials': 'ME', 'LastName': 'Beutel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}]",Journal of medical Internet research,['10.2196/13655']
1174,31481605,Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial.,"INTRODUCTION


AsthmaTuner is a novel self-management system consisting of a patient app, a cloud-based storage solution and a healthcare interface. Patients use Bluetooth spirometers to measure lung function (forced expiratory volume in 1 s) and can register symptoms. They then receive immediate feedback on asthma control and an image of the correct inhaler(s) to use and the dose. The aim of this pilot study was to evaluate the effect of AsthmaTuner on symptom control and adherence compared with conventional treatment.
MATERIAL AND METHODS


This multicentre physician-blinded crossover trial randomised patients in two groups that started with 8 weeks of AsthmaTuner or conventional treatment using a personalised printed treatment plan, with 2 weeks of washout between the crossover treatments. Participants in a primary or paediatric care setting in Sweden with asthma diagnosis, uncontrolled symptoms and Asthma Control Test (ACT) score <20 points were included. Symptom control was analysed using t-tests for the difference between the group means of the sums of ACT scores at each treatment end-visit, with 95% confidence intervals. Medical Adherence Report Scale (MARS) scores captured differences in adherence (remembering to take asthma medication) between treatment periods.
RESULTS


The study population consisted of 77 patients (60% females). The ACT score significantly improved with AsthmaTuner compared with conventional treatment (mean ACT difference 0.70, 95% CI 0.06-1.34; p=0.03). Adherence did not improve significantly in all participants, but did improve among those in primary care who used AsthmaTuner an average of once a week or more compared with conventional treatment (mean MARS difference 0.45, 95% CI 0.13-0.77; p=0.01).
CONCLUSIONS


AsthmaTuner improved symptom control in patients with uncontrolled asthma compared with conventional treatment.",2019,"The ACT significantly improved with AsthmaTuner compared with conventional treatment (mean 0.70 [0.06-1.34], p=0.03).","['patients with uncontrolled asthma', '77 patients (60% females', 'Participants in a primary or paediatric care setting in Sweden with asthma diagnosis, uncontrolled symptoms and Asthma Control Test (ACT)<20 points were included']","['AsthmaTuner or conventional treatment', 'AsthmaTuner', 'novel digital automated self-management solution']","['symptom control and adherence', 'Adherence', 'Medical Adherence Report Scale scores', 'Symptom control', 'symptom control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care (regime/therapy)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",77.0,0.0898205,"The ACT significantly improved with AsthmaTuner compared with conventional treatment (mean 0.70 [0.06-1.34], p=0.03).","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ljungberg', 'Affiliation': ""Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carleborg', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Hilmar', 'Initials': 'H', 'LastName': 'Gerber', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Öfverström', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Wolodarski', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Menshi', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Engdahl', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Eduards', 'Affiliation': 'Liljeholmen Health Care Centre, Stockholm Health Care Services (SLSO), Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nordlund', 'Affiliation': ""Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden bjorn.nordlund@ki.se.""}]",The European respiratory journal,['10.1183/13993003.00983-2019']
1175,31722536,Impact of Autonomic Regulation Therapy in Patients with Heart Failure: ANTHEM-HFrEF Pivotal Study Design.,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction) pivotal study is an adaptive, open-label, randomized, controlled study evaluating whether autonomic regulation therapy will benefit patients with advanced HFrEF. While early-phase studies have supported potential use of vagus nerve stimulation to deliver autonomic regulation therapy for HFrEF, results of larger clinical trials have been inconsistent. The ANTHEM-HFrEF study uses a novel design, with adaptive sample size selection, evaluating effects on morbidity and mortality as well as symptoms and function.
METHODS


The ANTHEM-HFrEF study will randomize patients (2:1) to autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone. The morbidity and mortality trial utilizes a conventional frequentist approach for analysis of the primary outcome end point-reduction in the composite of cardiovascular death or first HF hospitalization-and a Bayesian adaptive approach toward sample size selection. Embedded within the ANTHEM-HFrEF study is a second trial evaluating improvement in symptoms and function. Symptom/function success will require meeting 2 risk-related conditions (trend for reduced cardiovascular death/HF hospitalization and sufficient freedom from device-related serious adverse events) and 3 efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score).
CONCLUSIONS


Vagus nerve stimulation remains a promising, yet unproven treatment in HFrEF. A successful ANTHEM-HFrEF pivotal study would provide an important advance in HFrEF treatment and offer a model for expediting evaluation of new therapies.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT03425422.",2019,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","['Heart Failure with Reduced Ejection Fraction', 'patients with advanced HFrEF', 'Patients with Heart Failure']","['Autonomic Regulation Therapy', 'autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone', 'autonomic regulation therapy']","['efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score', 'morbidity and mortality']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0928951,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","[{'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS (J.B.).'}, {'ForeName': 'Helmut U', 'Initials': 'HU', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center, NY (H.U.K.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'University of Toronto, Mount Sinai Hospital, Division of Cardiology, Sinai Health Systems and University Health Network, Toronto, Canada (J.D.P.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California (J.R.T.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Wedge', 'Affiliation': 'Cardiovascular Clinical Science Foundation, Boston, MA (P.M.W.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin TX and Department of Biostatistics, Vanderbilt University, Nashville TN (B.R.S.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'Neurocardiology Center, University of California, Los Angeles (J.L.A.).'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005879']
1176,30804094,A Protective Mechanism against Illusory Perceptions Is Amygdala-Dependent.,"Most people have a clear sense of body ownership, preserving them from physical harm. However, perceptual body illusions - famously the rubber hand illusion (RHI) - can be elicited experimentally in healthy individuals. We hypothesize that the amygdala, a core component of neural circuits of threat processing, is involved in protective mechanisms against disturbed body perceptions. To test this hypothesis, we started by investigating two monozygotic human twin sisters with focal bilateral amygdala damage due to Urbach-Wiethe disease. Relative to 20 healthy women, the twins exhibited, on two occasions 1 year apart, augmented RHI responses in form of faster illusion onset and increased vividness ratings. Following up on these findings, we conducted a volumetric brain morphometry study involving an independent, gender-mixed sample of 57 healthy human volunteers (36 female, 21 male). Our results revealed a positive correlation between amygdala volume and RHI onset, i.e., the smaller the amygdala, the less time it took the RHI to emerge. This raised the question of whether a similar phenotype would result from experimental amygdala inhibition. To dampen amygdala reactivity, we intranasally administered the peptide hormone oxytocin to the same 57 individuals in a randomized trial before conducting the RHI. Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings. Together, the present series of experiments provides converging evidence for the amygdala's unprecedented role in reducing susceptibility to the RHI, thus protecting the organism from the potentially fatal threats of a distorted bodily self. SIGNIFICANCE STATEMENT  Compelling evidence indicates that the amygdala is of vital importance for danger detection and fear processing. However, lethal threats can arise not only from menacing external stimuli but also from distortions in bodily self-perception. Intriguingly, the amygdala's modulatory role in such illusory body perceptions is still elusive. To probe the amygdala's involvement in illusory body experiences, we conducted a multi-methodological series of experiments in a rare human amygdala lesion model, complemented by a morphological and pharmaco-modulatory experiment in healthy volunteers. Our findings convergently suggest that the amygdala's integrity is indispensable for maintaining an unbiased, precise perception of our bodily self. Hence, the amygdala might shield us against distortions in self-perception and the resultant loss of behavioral control of our organism.",2019,"Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings.","['20 healthy women', 'two monozygotic human twin sisters with focal bilateral amygdala damage due to Urbach-Wiethe disease', 'healthy volunteers', '57 healthy human volunteers (36 female, 21 male', 'healthy individuals']","['placebo, oxytocin', 'peptide hormone oxytocin']","['accelerated illusion onset and increased vividness ratings', 'vividness ratings', 'enhanced RHI responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0337521', 'cui_str': 'Twin sister (person)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0023795', 'cui_str': 'Hyalinosis Cutis et Mucosae'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone (substance)'}]","[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",20.0,0.0216404,"Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings.","[{'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany renehurlemann@icloud.com.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2577-18.2019']
1177,30891688,Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.,"BACKGROUND


Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations.
OBJECTIVES


To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention.
DESIGN


This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention.
PARTICIPANTS


Participants were community health center patients with body mass indexes of 30-44.9 kg/m 2 .
INTERVENTIONS


The weight loss intervention included tailored behavioral goal setting; weekly goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling.
MAIN MEASURES


At 6 and 12 months, participants' weight was measured and they reported if their provider delivered weight counseling (general or intervention-specific) at their most recent visit and their perception of providers' empathy. Providers' documentation of weight counseling was extracted from health records.
KEY RESULTS


Participants (n = 134-141) were predominantly female (70%) and African American (55%) with a mean age of 51 years and BMI of 36 kg/m 2 . Participant-reported provider weight counseling was not associated with weight change. However, participants whose providers documented intervention-specific counseling at any point during the intervention (n = 35) lost 3.1 kg (95% CI 0.4 to 5.7 kg) more than those whose providers documented only general weight counseling (n = 82) and 4.0 kg (95% CI 0.1 to 7.9 kg) more than those whose providers did not document weight counseling (n = 17). Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
CONCLUSIONS


Provider counseling that focuses specifically on engagement in a weight loss intervention may enhance weight loss outcomes relative to more general weight loss advice. Counseling that enhances patients' perceptions of empathy may be most beneficial for patients' weight loss.
TRIAL REGISTRATION


NCT01827800.",2019,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","['134-141) were predominantly female (70%) and African American (55%) with a mean age of 51\xa0years and BMI of 36\xa0kg/m 2 ', 'Participants (n\u2009', 'Participants were community health center patients with body mass indexes of 30-44.9\xa0kg/m 2 ']",['goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling'],"['general weight counseling', 'weight loss']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",141.0,0.0414384,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA. Megan.mcvay@ufl.edu.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Steinberg', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Askew', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04944-5']
1178,31012497,Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effects of 10 weeks of progressive vigorous-intensity interval training as a single intervention on body composition among 70-year-old individuals with central obesity.
DESIGN


Randomized controlled trial (ClinicalTrials.gov registration No. NCT03450655).
SETTING


Community-dwelling 70-year-old men and women living in the Umeå municipality in Sweden.
PARTICIPANTS


Seventy-seven 70-year-old men and women with central obesity (greater than 1 kg visceral adipose tissue [VAT] for women and greater than 2 kg VAT for men).
INTERVENTION


Participants allocated to the intervention group were offered a 10-week progressive concurrent exercise program performed three times per week. All participants in both groups had received tailored lifestyle recommendations focused on diet and physical activity at one occasion within 12 months prior to trial initiation.
MEASUREMENTS


The primary outcome was changes in VAT, and secondary outcomes included changes in total fat mass (FM), total lean body mass (LBM), and body mass index.
RESULTS


Comparing the groups, there were no significant differences in decrease of VAT mass (P = .10), although the intervention group significantly decreased FM by 716 g (P = .01) and gained LBM by 508 g (P = .03), compared to the control group. Furthermore, the effects of the training were significantly greater in the male subcohort (P < .05 for interaction), with positive effects also on VAT and FM, where men in the intervention group decreased VAT by 175 g (P < .05) and FM by 1364 g (P = .004), compared to the male controls.
CONCLUSIONS


The present trial demonstrates that 10 weeks of progressive vigorous interval training is sufficient to significantly decrease FM in older adults with central obesity, with positive effects also on LBM. J Am Geriatr Soc 67:1625-1631, 2019.",2019,"Comparing the groups, there were no significant differences in decrease of VAT mass (P = .10), although the intervention group significantly decreased FM by 716 g (P = .01) and gained LBM by 508 ","['70-year-old individuals with central obesity', 'Community-dwelling 70-year-old men and women living in the Umeå municipality in Sweden', 'Seventy-seven 70-year-old men and women with central obesity (greater than 1 kg visceral adipose tissue [VAT] for women and greater than 2 kg VAT for men', 'older adults with central obesity', 'Centrally Obese 70-Year-Old Individuals']","['progressive vigorous-intensity interval training', 'Interval Training', 'tailored lifestyle recommendations focused on diet and physical activity at one occasion', 'progressive vigorous interval training', '10-week progressive concurrent exercise program']","['changes in VAT', 'total fat mass (FM), total lean body mass (LBM), and body mass index', 'body composition', 'Visceral Adipose Tissue', 'FM', 'VAT mass', 'VAT']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600182'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}]",,0.120797,"Comparing the groups, there were no significant differences in decrease of VAT mass (P = .10), although the intervention group significantly decreased FM by 716 g (P = .01) and gained LBM by 508 ","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ballin', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Lundberg', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Sörlén', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hult', 'Affiliation': 'Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15919']
1179,31003961,"Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial.","BACKGROUND


Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones.
METHODS


We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete.
FINDINGS


Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3-5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10%) of 1920 patients (44 [12%] patients in the 0 s group, 28 [7%] in the 30 s group, 32 [8%] in the 60 s group, 36 [9%] in the 180 s group, and 59 [15%] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95% CI 0·31-0·73; p=0·0005 vs the 30 s group; 0·54, 0·36-0·81; p=0·003 vs the 60 s group; 0·61, 0·41-0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04-2·56; p=0·03). No difference in stone extraction (all ≥90%) was observed between groups. Following ERCP, 90 (5%) of 1920 patients had acute cholangitis, 14 (<1%) had acute cholecystitis, and five (<1%) had gastrointestinal bleeding, with no significant differences between groups. One (<1%) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment.
INTERPRETATION


A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
FUNDING


National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.",2019,"A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
","['Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP', 'common bile duct stones', '15 tertiary surgical centres in China', 'Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded', '83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387']","['Balloon dilation', 'balloon dilation', 'combined endoscopic sphincterotomy and balloon dilation', 'Prolonged dilation (300 s) with a 10 mm diameter balloon', 'small endoscopic sphincterotomy and balloon dilation', 'endoscopic retrograde cholangiopancreatography (ERCP', 'endoscopic sphincterotomy', 'endoscopic sphincterotomy and balloon dilation', 'Endoscopic sphincterotomy']","['occurrence of pancreatitis', 'frequency of post-ERCP pancreatitis', 'occurrence of post-ERCP pancreatitis', 'acute cholangitis', 'Prolonged dilation', 'gastrointestinal bleeding', 'Overall, post-ERCP pancreatitis', 'acute cholecystitis', 'overall frequency of post-ERCP pancreatitis', 'stone extraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0085263', 'cui_str': 'Endoscopic Biliary Sphincterotomy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0267917', 'cui_str': 'Acute cholangitis (disorder)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0149520', 'cui_str': 'Acute Cholecystitis'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",3721.0,0.246079,"A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Special Minimally Invasive Surgery, CHESS Center, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis Medical Center and Sacramento Veterans Affairs Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery Department, Shandong Provincial Third Hospital, Jinan, China.'}, {'ForeName': 'Wence', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Leida', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xue', 'Affiliation': 'Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China; Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Sixth Hospital of Shanxi Medical University (General Hospital of TISCO), Taiyuan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yingmei', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Department of Hepatobiliary and Hydatid, Digestive and Vascular Surgery Centre, Xinjiang Key Laboratory of Echinococcosis and Liver Surgery Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Kailin', 'Initials': 'K', 'LastName': 'Cai', 'Affiliation': 'Gastrointestinal Surgery Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Senlin', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Department of Biliopancreatic Endoscopic Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Qiyong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, School of Medicine, Shulan (Hangzhou) Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yue', 'Affiliation': 'Department of Special Minimally Invasive Surgery, CHESS Center, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery Department, Shandong Provincial Third Hospital, Jinan, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Centre of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ""Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zilong', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Qunwei', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China; Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Bendong', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Department of General Surgery, Sixth Hospital of Shanxi Medical University (General Hospital of TISCO), Taiyuan, China.'}, {'ForeName': 'Mingning', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.'}, {'ForeName': 'Ruoyan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Tiemin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary and Hydatid, Digestive and Vascular Surgery Centre, Xinjiang Key Laboratory of Echinococcosis and Liver Surgery Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Gastrointestinal Surgery Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lichao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biliopancreatic Endoscopic Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Kangjie', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Zhengfeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Fangzhao', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lingen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Azumi', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Kiyohito', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Ula', 'Initials': 'U', 'LastName': 'Nur', 'Affiliation': 'Department of Public Health, College of Health Sciences, Qatar University Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Weiderpass', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China. Electronic address: drlixun@163.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30075-5']
1180,31016610,Effects of acceptance and reappraisal on body dissatisfaction: an experimental comparison of two adaptive emotion regulation strategies.,"BACKGROUND


In recent years, research has increasingly focused on body dissatisfaction, which is associated with numerous negative psychological and physical health consequences and, more importantly, with the development and maintenance of eating pathology.
OBJECTIVE


In the present study, we focused on the effect of two adaptive emotion regulation strategies (acceptance and reappraisal) on body dissatisfaction compared to a control group, and pre- and post-induction of body dissatisfaction.
METHODS


A total of 105 women [mean age (M) = 22.07; standard deviation (SD) = 6.11] were randomly assigned to one of the two emotion regulation conditions: acceptance (n = 35) and reappraisal (n = 35) or to a control group (n = 35). Participants were instructed accordingly with the condition that was assigned (acceptance or reappraisal). Participants were then induced body dissatisfaction by exposure to images representing the female thin-ideal and were asked to respond to their body-related feelings according to the instructions. Outcomes assessed were body dissatisfaction, and positive and negative affect.
RESULTS


Results indicated a significant increase of body satisfaction in the acceptance and reappraisal conditions from pre- to post-induction of body dissatisfaction, compared to control group which suffered a significant decrease in body satisfaction. Moreover, in the control group, positive affect significantly decreased and negative affect increased from pre- to post-induction, and did not change significantly, neither in the acceptance nor in the reappraisal condition.
CONCLUSIONS


Our findings highlight the positive effects of acceptance and reappraisal as emotion regulation strategies on body dissatisfaction and on positive and negative affect.
LEVEL OF EVIDENCE


Experimental study, Level 1.",2020,"RESULTS


Results indicated a significant increase of body satisfaction in the acceptance and reappraisal conditions from pre- to post-induction of body dissatisfaction, compared to control group which suffered a significant decrease in body satisfaction.",['105 women [mean age (M)\u2009=\u200922.07; standard deviation (SD)\u2009=\u20096.11'],"['acceptance and reappraisal', 'two emotion regulation conditions: acceptance (n\u2009=\u200935) and reappraisal (n\u2009=\u200935) or to a control group', 'adaptive emotion regulation strategies (acceptance and reappraisal']","['body dissatisfaction', 'body satisfaction', 'acceptance and reappraisal conditions from pre- to post-induction of body dissatisfaction', 'body dissatisfaction, and positive and negative affect']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",105.0,0.0298214,"RESULTS


Results indicated a significant increase of body satisfaction in the acceptance and reappraisal conditions from pre- to post-induction of body dissatisfaction, compared to control group which suffered a significant decrease in body satisfaction.","[{'ForeName': 'Alice Beatrice', 'Initials': 'AB', 'LastName': 'Prefit', 'Affiliation': 'Evidence-based Assessment and Psychological Interventions Doctoral School, Babeș-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Diana-Mirela', 'Initials': 'DM', 'LastName': 'Cândea', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, The International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University of Cluj-Napoca, 37, Republicii Street, Cluj-Napoca, Romania.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Szentagotai-Tătar', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, The International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University of Cluj-Napoca, 37, Republicii Street, Cluj-Napoca, Romania. auraszentagotai@psychology.ro.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00691-y']
1181,31000133,Effect of standard dose paracetamol versus placebo as antipyretic therapy on liver injury in adult dengue infection: a multicentre randomised controlled trial.,"BACKGROUND


Dengue is a common cause of acute liver failure in tropical countries. Paracetamol is the recommended antipyretic for dengue. Related observational studies in dengue have suggested that excessive paracetamol intake is related to hepatic injury. We aimed to evaluate whether standard dose paracetamol as an antipyretic in dengue infection caused transaminase elevation, and to evaluate the efficacy of paracetamol.
METHODS


In this randomised, double-blind, placebo-controlled trial, adult participants (aged ≥18 years) with dengue, as confirmed by either positive NS1 antigen, positive dengue IgM antigen with thrombocytopenia, or positive PCR test, were enrolled at three Royal Thai Army hospitals in Thailand. Key exclusion criteria were baseline AST or ALT concentrations of more than 3 times the upper limit of normal, cirrhosis, indication of paracetamol other than dengue infection, concurrent diagnosis of other causes of fever, or pregnancy. Patients were randomly assigned (1:1), by a computer-generated block randomisation procedure (block size of six), to receive either paracetamol (500 mg) or placebo (500 mg) every 4 h when body temperature exceeded 38°C during hospitalisation. Participants and investigators were masked to treatment assignment. The primary outcome was the proportion of participants with transaminase elevation, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) concentrations of more than 3 times the upper limit of normal on recovery day, in the intention-to-treat population. Prespecified interim analyses for safety and efficacy were performed with group sequential stopping boundaries. This trial is registered with ClinicalTrials.gov, number NCT02833584.
FINDINGS


Between Sept 1, 2016, and Dec 12, 2017, 125 participants were randomly assigned to receive either paracetamol (n=63) or placebo (n=62). 123 participants were included in the intention-to-treat population. The median daily dose of study medication was 1·5 g (IQR 0·8-2·0). The study was terminated early owing to a higher rate of transaminase elevation in the paracetamol group than in the placebo group (22% vs 10%; incidence rate ratio 3·77, 95% CI 1·36-10·46, p=0·011). The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT). Three participants in the paracetamol group had severe dengue: two had upper gastric haemorrhage and one had acute kidney injury. No patients died or had liver failure.
INTERPRETATION


Use of standard dose paracetamol in dengue infection increased the incidence of transaminase elevation, and also overall transaminase concentrations in the absence of a counterbalancing reduced fever or pain score.
FUNDING


Phramongkutklao College of Medicine.",2019,"The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT).","['Between Sept 1, 2016, and Dec 12, 2017, 125 participants', 'group had severe dengue: two had upper gastric haemorrhage and one had acute kidney injury', '123 participants were included in the intention-to-treat population', 'liver injury in adult dengue infection', 'adult participants (aged ≥18 years) with dengue, as confirmed by either positive NS1 antigen, positive dengue IgM antigen with thrombocytopenia, or positive PCR test, were enrolled at three Royal Thai Army hospitals in Thailand']","['Paracetamol', 'paracetamol', 'paracetamol (500 mg) or placebo', 'placebo']","['rate of transaminase elevation', 'proportion of participants with transaminase elevation, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) concentrations', 'safety and efficacy', 'change of AST and ALT concentrations', 'died or had liver failure']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019100', 'cui_str': 'Philippine Hemorrhagic Fever'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0235325', 'cui_str': 'Gastric hemorrhage (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0019997', 'cui_str': 'Hospitals, Army'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}]",123.0,0.787739,"The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT).","[{'ForeName': 'Vasin', 'Initials': 'V', 'LastName': 'Vasikasin', 'Affiliation': 'Division of Infectious Diseases, Phramongkutklao Hospital, Bangkok, Thailand. Electronic address: vvasin@gmail.com.'}, {'ForeName': 'Thanawith', 'Initials': 'T', 'LastName': 'Rojdumrongrattana', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Worayon', 'Initials': 'W', 'LastName': 'Chuerboonchai', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Thanawhan', 'Initials': 'T', 'LastName': 'Siriwiwattana', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Wittaya', 'Initials': 'W', 'LastName': 'Thongtaeparak', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Niyasom', 'Affiliation': 'Department of Internal Medicine, Ananda Mahidol Hospital, Lopburi, Thailand.'}, {'ForeName': 'Nawarat', 'Initials': 'N', 'LastName': 'Lertliewtrakool', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Sitawee', 'Initials': 'S', 'LastName': 'Jitsiri', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Dhitiwat', 'Initials': 'D', 'LastName': 'Changpradub', 'Affiliation': 'Division of Infectious Diseases, Phramongkutklao Hospital, Bangkok, Thailand.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30032-4']
1182,31003626,Effect of a high-fat Mediterranean diet on bodyweight and waist circumference: a prespecified secondary outcomes analysis of the PREDIMED randomised controlled trial.,"BACKGROUND


Because of the high density of fat, high-fat diets are perceived as likely to lead to increased bodyweight, hence health-care providers are reluctant to recommend them to overweight or obese individuals. We assessed the long-term effects of ad libitum, high-fat, high-vegetable-fat Mediterranean diets on bodyweight and waist circumference in older people at risk of cardiovascular disease, most of whom were overweight or obese.
METHODS


PREDIMED was a 5 year parallel-group, multicentre, randomised, controlled clinical trial done in primary care centres affiliated to 11 hospitals in Spain. 7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors were randomly assigned (1:1:1) with a computer-generated number sequence to one of three interventions: Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat; n=2450). Energy restriction was not advised, nor was physical activity promoted. In 2016, we reported the 5 year changes in bodyweight and waist circumference, but because of a subsequently identified protocol deviation (including enrolment of household members without randomisation, assignment to a study group without randomisation of some participants at one of 11 study sites, and apparent inconsistent use of randomisation tables at another site; 866 [11·6%] participants were affected in total), we have withdrawn our previously published report and now report revised effect estimates based on reanalyses that do not rely exclusively on the assumption that all the participants were randomly assigned. In this analysis of the trial, we measured bodyweight and waist circumference at baseline and yearly for 5 years in the intention-to-treat population. The PREDIMED trial is registered with ISRCTN.com, number ISRCTN35739639.
FINDINGS


After a median 4·8 years (IQR 2·8-5·8) of follow-up, participants in all three groups had marginally reduced bodyweight and increased waist circumference. After multivariable adjustment, including adjustment for propensity scores and use of robust variance estimators, the difference in 5 year changes in bodyweight in the Mediterranean diet with olive oil group was -0·410 kg (95% CI -0·830 to 0·010; p=0·056) and in the nut group was -0·016 kg (-0·453 to 0·421; p=0·942), compared with the control group. The adjusted difference in 5 year changes in waist circumference was -0·466 cm (-1·109 to 0·176; p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
INTERPRETATION


A long-term intervention with an unrestricted-calorie, high-vegetable-fat Mediterranean diet was associated with no significant difference in bodyweight and some evidence of less gain in central adiposity compared with a control diet. These results lend support to advice not restricting intake of healthy fats for bodyweight maintenance.
FUNDING


Spanish Government, CIBERobn, Instituto de Salud Carlos III, Hojiblanca, Patrimonio Comunal Olivarero, California Walnut Commission, Borges SA, and Morella Nuts.",2019,"p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
","['primary care centres affiliated to 11 hospitals in Spain', '7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors', 'older people at risk of cardiovascular disease, most of whom were overweight or obese']","['high-fat Mediterranean diet', 'ad libitum, high-fat, high-vegetable-fat Mediterranean diets', 'Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat', 'Mediterranean diet with olive oil']","['waist circumference', 'central adiposity', 'bodyweight and increased waist circumference', 'bodyweight and waist circumference']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",7447.0,0.182165,"p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
","[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain. Electronic address: restruch@clinic.ub.es.""}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine and Public Health, Universidad de Navarra-Institute of Health Research of Navarra, Pamplona, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Human Nutrition Department, Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili, University Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital delMar, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Chiva-Blanch', 'Affiliation': ""Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Institute of Health Sciences, University of Balearic Islands and Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Cardiology, University Hospital of Alava, Vitoria, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Research Institute of Biomedical Research and Health Services and School of Medicine, University of Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Buil-Cosiales', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institute of Health Research of Navarra, Pamplona, Spain.'}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Sorlí', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain; Primary Care Division, Valencia Institute of Health, Burjassot, Valencia, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Muñoz', 'Affiliation': 'Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora-Gallisá', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Tarragona, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Lamuela-Raventós', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Nutrition and Bromatology, School of Pharmacy, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Alimentación y Seguridad Alimentaria, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Serra-Mir', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Internal Medicine and Lipid Clinic, Department of Endocrinology and Nutrition, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Internal Medicine and Lipid Clinic, Department of Endocrinology and Nutrition, University of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30074-9']
1183,30449328,"Does memantine improve memory in subjects with focal-onset epilepsy and memory dysfunction? A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


Excitotoxic injury involving N-methyl-d-aspartate (NMDA) receptor hyperactivity contributes to epilepsy-related memory dysfunction (ERMD). Current treatment strategies for ERMD have limited efficacy and fail to target the underlying pathophysiology. The present pilot study evaluated the efficacy of memantine, an NMDA receptor antagonist, for the treatment of ERMD in adults with focal-onset seizures.
METHODS


Subjects underwent cognitive testing at baseline, after a 13-week randomized, parallel-group, double-blinded phase (of memantine titrated to 10 mg bid or placebo), and following a 13-week open-label extension phase (of memantine titrated to 10 mg bid). The selective reminding test (SRT) continuous long-term retrieval (CLTR) score and 7/24 Spatial Recall Test learning score served as the primary outcome measures. Secondary measures included tests of attention span, fluency, visual construction, and response inhibition, as well as assessments of quality of life, depression, sleepiness, and side effects.
RESULTS


Seventeen subjects contributed data to the blinded phase (n = 8 memantine, n = 9 placebo). No significant differences were seen between groups on the primary or secondary outcome measures. Pooled data at the end of the open-label phase from 10 subjects (initially randomized to memantine n = 3 or placebo n = 7) demonstrated statistically significant improvement from baseline in CLTR score, memory-related quality of life, spatial span, and response inhibition. No significant changes were evident in depression, sleepiness, side effects, or seizure frequency throughout the trial.
SIGNIFICANCE


Results demonstrated no significant effect of memantine on cognition when assessed at the end of the blinded period. Pooled data at the end of the open-label phase showed significant improvement over baseline performance in measures of verbal memory, frontal-executive function, and memory-related quality of life. These improvements, however, may be due to practice effects and should be interpreted cautiously. Findings suggest a favorable safety profile of memantine in the setting of epilepsy.",2018,No significant differences were seen between groups on the primary or secondary outcome measures.,"['Subjects underwent cognitive testing at baseline', 'subjects with focal-onset epilepsy and memory dysfunction', 'adults with focal-onset seizures']","['memantine titrated to 10\u202fmg bid or placebo', 'memantine', 'placebo', 'N-methyl-d-aspartate (NMDA) receptor hyperactivity']","['CLTR score, memory-related quality of life, spatial span, and response inhibition', 'verbal memory, frontal-executive function, and memory-related quality of life', 'selective reminding test (SRT) continuous long-term retrieval (CLTR) score and 7/24 Spatial Recall Test learning score', 'tests of attention span, fluency, visual construction, and response inhibition, as well as assessments of quality of life, depression, sleepiness, and side effects', 'depression, sleepiness, side effects, or seizure frequency']","[{'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C3887551', 'cui_str': 'Memory dysfunction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",17.0,0.429504,No significant differences were seen between groups on the primary or secondary outcome measures.,"[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Leeman-Markowski', 'Affiliation': 'Research Service, VA New York Harbor Healthcare System, New York, NY, USA; Department of Neurology, New York University Langone Medical Center, New York, NY, USA. Electronic address: beth.leeman-markowski@nyumc.org.'}, {'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology & Neurological Sciences, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Moo', 'Affiliation': 'Geriatric Research Education and Clinical Center, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Hoch', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Garcia', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA; Newton-Wellesley Neurology Associates, PC, Newton Lower Falls, MA, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Schachter', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2018.06.047']
1184,31721487,Impact of Pharmacogenomics on Clinical Outcomes for Patients Taking Medications With Gene-Drug Interactions in a Randomized Controlled Trial.,"OBJECTIVE


The objective of the Genomics Used to Improve DEpression Decisions (GUIDED) trial was to evaluate the utility of pharmacogenomic testing to improve outcomes among patients with major depressive disorder (MDD) who had not responded to at least 1 prior medication trial. The objective of the present analysis was to assess outcomes for the subset of patients expected to benefit from combinatorial pharmacogenomic testing because they were taking medications with predicted gene-drug interactions.
METHODS


Participants (enrolled from April 14, 2014, to February 10, 2017) had an inadequate response to at least 1 psychotropic medication in the current episode of MDD. Patients were randomized to treatment as usual (TAU) or the guided-care arm, in which clinicians had access to a combinatorial pharmacogenomic test report to inform medication selection. Patients and raters were blinded to study arm through week 8. The following outcomes were assessed using the 17-item Hamilton Depre​ssion Rating Scale (HDRS-17): symptom improvement (percent change in HDRS-17 score), response (≥ 50% decrease in HDRS-17 score), and remission (HDRS-17 score ≤ 7). In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069). Here, a post hoc analysis of patients who were taking medications subject to gene-drug interactions at baseline as predicted by combinatorial pharmacogenomic testing (N = 912) is presented.
RESULTS


Among participants taking medications subject to gene-drug interactions at baseline, outcomes at week 8 were significantly improved for those in the guided-care arm compared to TAU (symptom improvement: 27.1% versus 22.1%, P = .029; response: 27.0% versus 19.0%, P = .008; remission: 18.2% versus 10.7%, P = .003). When patients who switched medications were assessed, all outcomes were significantly improved in the guided-care arm compared to TAU (P = .011 for symptom improvement, P = .011 for response, P = .008 for remission).
CONCLUSIONS


By identifying and focusing on the patients with predicted gene-drug interactions, use of a combinatorial pharmacogenomic test significantly improved outcomes among patients with MDD who had at least 1 prior medication failure.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02109939​.",2019,"In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069).","['Participants (enrolled from April 14, 2014, to February 10, 2017) had an inadequate response to at least 1 psychotropic medication in the current episode of MDD', 'patients who were taking medications subject to gene-drug interactions at baseline as predicted by combinatorial pharmacogenomic testing (N = 912) is presented', 'Patients Taking Medications', 'patients with MDD who had at least 1 prior medication failure', 'patients with major depressive disorder (MDD) who had not responded to at least 1 prior medication trial']","['usual (TAU) or the guided-care arm, in which clinicians had access to a combinatorial pharmacogenomic test report to inform medication selection']","['17-item Hamilton Depre\u200bssion Rating Scale (HDRS-17): symptom improvement (percent change in HDRS-17 score), response (≥ 50% decrease in HDRS-17 score), and remission (HDRS-17 score ≤ 7']","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Testing'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.18046,"In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069).","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, The Corporal Michael Crescenz VAMC, 3535 Market Street, Room 689, Philadelphia, PA 19104. thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry, and National Network of Depression Centers, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare, Worcester, Massachusetts, USA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Department of Psychiatry, Washington University School of Medicine, and the John Cochran Veteran's Administration Hospital, St Louis, Missouri, USA.""}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry, McLean Hospital, Harvard Medical School, Belmont, Massachusetts, USA.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Mondimore', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, Wichita, Kansas, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc, Mason, Ohio, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Myriad Genetics, Inc, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jablonski', 'Affiliation': 'Assurex Health, Inc, Mason, Ohio, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry, and National Network of Depression Centers, Ann Arbor, Michigan, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12910']
1185,30987814,Chlorhexidine for meatal cleaning in reducing catheter-associated urinary tract infections: a multicentre stepped-wedge randomised controlled trial.,"BACKGROUND


Evidence for the benefits of antiseptic meatal cleaning in reducing catheter-associated urinary tract infection (UTI) is inconclusive. We assessed the efficacy of 0·1% chlorhexidine solution compared with normal saline for meatal cleaning before urinary catheter insertion in reducing the incidence of catheter-associated asymptomatic bacteriuria and UTI.
METHODS


A cross-sectional, stepped-wedge, open-label, randomised controlled trial was undertaken in Australian hospitals. Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30 000 hospital admissions per year. Hospitals were randomly assigned to an intervention crossover date using a computer-generated randomisation system. Crossover dates occurred every 8 weeks; during the first 8 weeks of the study, no hospitals were exposed to the intervention (control phase), after which each hospital sequentially crossed over from the control to the intervention every 8 weeks. Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study. Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI. The intervention was the use of 0·1% chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline used in the control phase. Masking of hospitals was not possible because it was not feasible to mask staff administering the intervention. The co-primary outcomes were the number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days and were assessed within 7 days of catheter insertion in the intention-to-treat population. This trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12617000373370.
FINDINGS


21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled and randomised to one of three intervention crossover dates. 1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period. In the control period, 13 catheter-associated UTI and 29 catheter-associated asymptomatic bacteriuria events in 2889 catheter-days (0·45 catheter-associated UTI cases and 1·00 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) were recorded compared with four catheter-associated UTI and 16 catheter-associated asymptomatic bacteriuria events in 2338 catheter-days (0·17 catheter-associated UTI cases and 0·68 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) during the intervention period. The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080). There were no reported adverse events.
INTERPRETATION


The use of chlorhexidine solution for meatal cleaning before catheter insertion decreased the incidence of catheter-associated asymptomatic bacteriuria and UTI and has the potential to improve patient safety.
FUNDING


HCF Research Foundation.",2019,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","['Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI', 'Australian hospitals', '1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period', '21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled', 'Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study', 'Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30\u2008000 hospital admissions per year']","['Chlorhexidine', 'normal saline', 'chlorhexidine solution', 'antiseptic meatal cleaning', 'chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline']","['incidence of catheter-associated asymptomatic bacteriuria', 'adverse events', 'catheter-associated urinary tract infections', 'number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days', 'incidence of catheter-associated UTI', 'asymptomatic bacteriuria events']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439508', 'cui_str': 'per year'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",21.0,0.152964,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","[{'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute, Australian Catholic University & St Vincent's Health Australia, Sydney, NSW, Australia; Lifestyle Research Centre, Avondale College of Higher Education, Cooranbong, NSW, Australia.""}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Infectious Prevention and Healthcare Epidemiology Unit, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gregory', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine Australian Catholic University, Watson, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collignon', 'Affiliation': 'Australian Capital Territory Pathology, Canberra Hospital and Health Services, Yamba Drive, Garran, ACT, Australia; Medical School, Australian National University, Acton, ACT, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30736-9']
1186,30982680,"Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation.","BACKGROUND


Angiotensin receptor and neprilysin inhibition (ARNI) has been shown to reduce cardiovascular mortality by 20% as compared with enalapril in a randomized controlled trial. However, there is a paucity of real-world data on the effects of ARNI in heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension.
METHODS


Between 2016 and 2017, we recruited 466 HFrEF patients treated with sacubitril/valsartan (Group A) and 466 patients managed with standard HF treatment without ARNI (Group B) in a HF referral center. Baseline characteristics and clinical outcomes were collected between both groups.
RESULTS


Baseline characteristics were comparable between the two groups. During a follow-up period of 15 months, death from cardiovascular causes or first unplanned hospitalization for HF occurred in 100 patients in Group A (21.5%) and 144 in Group B (30.9%, hazard ratio 0.66; 95% CI 0.51-0.85; p=0.001). The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients. Among patients with different chronic kidney disease stages and normotensive patients, treatment with sacubitril/valsartan showed more favorable outcomes than treatment with standard HF care without ARNI. However, in patients with baseline systolic blood pressure lower than 100mmHg, there were no significant differences of outcomes in both groups. Among Group A patients, escalation of sacubitril/valsartan was associated with better outcomes.
CONCLUSIONS


Our study demonstrated the effectiveness of sacubitril/valsartan on HFrEF patients in real world practice, including those with advanced renal impairment.",2019,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","['heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension', 'Group A) and 466 patients managed with', 'heart failure with reduced ejection fraction patients', '466 HFrEF patients treated with', 'Between 2016 and 2017', 'HFrEF patients in real world practice, including those with advanced renal impairment', 'patients with different chronic kidney disease stages and normotensive patients']","['standard HF treatment without ARNI', 'enalapril', 'Sacubitril/valsartan', 'sacubitril/valsartan', 'Angiotensin receptor and neprilysin inhibition (ARNI']","['baseline systolic blood pressure', 'death from cardiovascular causes or first unplanned hospitalization for HF', 'cardiovascular mortality', 'incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}]",466.0,0.062689,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","[{'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'An-Ning', 'Initials': 'AN', 'LastName': 'Feng', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Man-Cai', 'Initials': 'MC', 'LastName': 'Fong', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chao-Wen', 'Initials': 'CW', 'LastName': 'Hsueh', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Tsung', 'Initials': 'WT', 'LastName': 'Lai', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chih', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Farrer Park Hospital, Singapore.'}, {'ForeName': 'Chi-Nan', 'Initials': 'CN', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hung-Chuan', 'Initials': 'HC', 'LastName': 'Chang', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: adr@chgh.org.tw.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.03.010']
1187,30734333,Letter to Editor: Role of Pharmacotherapy in Patients With Coexisting Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus.,"We read with interest a recent article written by Yan et al. (1)  The authors conducted a randomized trial in patients with coexisting type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) to receive liraglutide, sitagliptin, or insulin glargine as add-on to metformin. The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM. However, the clinical meaningfulness of these pharmacologic treatments has not been conclusively established, especially since histopathology was not used to diagnose and determine the severity of NAFLD in that study. This article is protected by copyright. All rights reserved.",2019,"The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM.","['patients with coexisting type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) to receive', 'Patients With Coexisting Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus', 'patients with NAFLD and T2DM']","['Pharmacotherapy', 'liraglutide, sitagliptin, or insulin glargine as add-on to metformin', 'liraglutide or sitagliptin']","['body weight, intrahepatic lipid, and visceral adipose tissue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}]",,0.0149318,"The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM.","[{'ForeName': 'Sikarin', 'Initials': 'S', 'LastName': 'Upala', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30551']
1188,31002147,Single nucleotide polymorphisms at the ADIPOQ gene locus rs1501299 interact with different type of dietary fatty acids in two hypocaloric diets.,"OBJECTIVE


Some adiponectin gene (ADIPOQ) and single nucleotide polymorphisms (SNPs) have been related to adiponectin levels and metabolic parameters. Few studies of interaction gene-nutrient have been realized in this topic area. The aim of our study was to analyze the effect of the rs1501299 ADIPOQ gene polymorphism, and the dietary intake on total adiponectin levels and the insulin resistance changes after an enriched-monounsaturated fat (Diet M) vs. an enriched-polyunsaturated fat hypocaloric diet (Diet P).
PATIENTS AND METHODS


A Caucasian population of 363 obese patients was enrolled in a randomized clinical trial with two hypocaloric diets. Before and after 12 weeks on each hypocaloric diet, an anthropometric evaluation, an assessment of nutritional intake and a biochemical analysis were realized. The statistical analysis was performed for the combined GT and TT as a group (mutant) and GG as second group (wild).
RESULTS


With both caloric restriction strategies, body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure and leptin levels decreased. After Diet P, only subjects with GG genotype showed a significant improvement in the insulin levels (GG vs. GT±TT) (-3.2±1.0 mU/L vs. -0.6±0.4 mU/L: p=0.01) and in the homeostasis model assessment (HOMA-IR) (-1.1±0.2 units vs. -0.3±0.4 units: p=0.02). The same improvement in both parameters was reported after Diet M: insulin levels (-3.7±0.9 mU/L vs. -0.4±0.5 mU/L: p=0.01) and HOMA-IR (-1.0±0.2 units vs. -0.4±0.3 units: p=0.03). After weight loss with diet M, both genotypes (GG vs. GT±TT) showed similar decrease in total cholesterol and LDL-cholesterol. Only subjects with GG genotype showed a significant increase of the adiponectin levels after both diets: (Diet P: 9.3±3.0 ng/dl vs. Diet M: 8.2±2.9 ng/dl: p=0.38).
CONCLUSIONS


The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.",2019,The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.,['A Caucasian population of 363 obese patients'],['enriched-monounsaturated fat (Diet M) vs. an enriched-polyunsaturated fat hypocaloric diet (Diet P'],"['insulin and HOMA-IR', 'total cholesterol and LDL-cholesterol', 'body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure and leptin levels', 'adiponectin levels', 'homeostasis model assessment (HOMA-IR) ', 'total adiponectin levels', 'insulin levels (GG vs. GT±TT', 'HOMA-IR']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",363.0,0.0296689,The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.,"[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. dadluis@yahoo.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201904_17577']
1189,31882732,"Antiplatelet effects of citalopram in patients with ischaemic stroke: A randomized, placebo-controlled, double-blind study.","We evaluated the effect of SSRI treatment on platelet aggregation in patients with ischaemic stroke and included patients from the randomized double-blind controlled study of citalopram in acute ischaemic stroke (TALOS). Patients on clopidogrel were included 6 months after acute ischaemic stroke. Platelet parameters, including P2Y12 platelet reactivity using the VerifyNow System, were measured at the last day of study treatment and repeated after a 14-day wash-out period. A total of 60 patients were included (n = 32 randomized to citalopram). Platelet aggregation levels did not differ between the citalopram group (mean 116, 95% CI 89 to 143) and the placebo group (mean 136, 95% CI 109 to 163) (On-treatment, p = 0.14). Similarly, there was no significant change in platelet aggregation in the citalopram group from on-treatment to post-treatment (mean difference 2.0; 95% CI -18 to 14). Platelet count, size and turnover were not affected by SSRI treatment. In conclusion, SSRI therapy did not lead to statistically significant inhibition of platelet aggregation in ischaemic stroke patients treated with clopidogrel.",2019,"In conclusion, SSRI therapy did not lead to statistically significant inhibition of platelet aggregation in ischaemic stroke patients treated with clopidogrel.","['60 patients were included (n\u2009=\u200932 randomized to', 'patients with ischaemic stroke and included patients', 'acute ischaemic stroke (TALOS', 'ischaemic stroke patients treated with', 'patients with ischaemic stroke']","['SSRI therapy', 'clopidogrel', 'placebo', 'citalopram', 'SSRI']","['Platelet count, size and turnover', 'Platelet aggregation levels', 'platelet aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",32.0,0.48893,"In conclusion, SSRI therapy did not lead to statistically significant inhibition of platelet aggregation in ischaemic stroke patients treated with clopidogrel.","[{'ForeName': 'Kristian Lundsgaard', 'Initials': 'KL', 'LastName': 'Kraglund', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Janne Kaergaard', 'Initials': 'JK', 'LastName': 'Mortensen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren Paaske', 'Initials': 'SP', 'LastName': 'Johnsen', 'Affiliation': 'Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Erik Lerkevang', 'Initials': 'EL', 'LastName': 'Grove', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. erikgrove@dadlnet.dk.'}]",Scientific reports,['10.1038/s41598-019-56487-8']
1190,30982943,Integrating eating disorder and weight gain prevention: a pilot and feasibility trial of INSPIRE.,"PURPOSE


The current study adapted evidence-based prevention programs to promote positive health behaviors among racially and ethnically diverse young adult women. Two successful programs (The Body Project and the Healthy Weight Intervention) were integrated to evaluate their feasibility, acceptability, and preliminary efficacy in reducing risk for both eating pathology and weight gain. Intervention features extended the previous prevention efforts by emphasizing broad appearance ideals to enhance relevancy for women of color and incorporating distress tolerance and emotion regulation skills training.
METHOD


Individuals were excluded if they met criteria for an eating disorder diagnosis and/or obesity, as this was a prevention project. 27 young adult women participated (M age = 18.59; SD = 1.01). The following racial/ethnic groups were represented: 48.1% White, 25.9% Asian, 22.2% Black, and 3.7% Latina. After each meeting, participants completed satisfaction measures and therapists assessed intervention feasibility. Participants also completed comprehensive questionnaires at pretest (baseline), posttest (8 weeks), and 4-week follow-up.
RESULTS


Descriptive statistics and content analyses of open-ended questions indicated that the intervention was both acceptable and feasible. Hierarchical linear models evaluating within-subject change over time indicated reductions in several risk factors that were sustained at follow-up: eating pathology, appearance dissatisfaction, thin-ideal internalization, restrained eating, negative affect, emotion dysregulation, and fat intake. BMI did not change from pretest to posttest; however, BMI increased from posttest to follow-up (mean weight increase = 0.34 kg).
CONCLUSION


Results suggest that a prevention program designed to be more culturally sensitive is feasible and acceptable. Findings provide preliminary support for reducing the risk of eating pathology and promoting positive health behaviors.
LEVEL OF EVIDENCE


Time series with intervention, Level IV.
TRIAL REGISTRATION


ClinicalTrails.gov ID: NCT03317587.",2020,"Hierarchical linear models evaluating within-subject change over time indicated reductions in several risk factors that were sustained at follow-up: eating pathology, appearance dissatisfaction, thin-ideal internalization, restrained eating, negative affect, emotion dysregulation, and fat intake.","['Individuals were excluded if they met criteria for an eating disorder diagnosis and/or obesity, as this was a prevention project', 'racially and ethnically diverse young adult women', '27 young adult women participated (M age\u2009=\u200918.59; SD\u2009=\u20091.01']",[],"['Level IV', 'BMI']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",27.0,0.0418563,"Hierarchical linear models evaluating within-subject change over time indicated reductions in several risk factors that were sustained at follow-up: eating pathology, appearance dissatisfaction, thin-ideal internalization, restrained eating, negative affect, emotion dysregulation, and fat intake.","[{'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Simpson', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA. simpsoncc2@vcu.edu.'}, {'ForeName': 'C Blair', 'Initials': 'CB', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Departments of Psychology and Pediatrics, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00685-w']
1191,30466545,A randomized clinical trial of cue exposure treatment through virtual reality for smoking cessation.,"INTRODUCTION


Cue-induced craving is a major motivator of smoking behavior, and, more importantly, a predictor of relapse. Previous studies demonstrated that cue exposure treatment (CET) reduces both cue-induced craving and daily nicotine intake in smokers. However, the efficacy of CET for smoking cessation has rarely been tested in controlled trials. This two-site randomized clinical trial explored the effectiveness of a CET procedure in combination with a Cognitive-Behavioral Treatment (CBT) for smoking cessation among treatment-seeking patients from the general population.
METHODS


One hundred and two smokers were randomly assigned to one of two treatment conditions: CBT (n = 52) or CBT + CET (n = 50). The CBT intervention involved group-based sessions over the course of 6 weeks. In addition to CBT, participants in the CBT + CET condition received 5 individual sessions of CET through virtual reality.
RESULTS


The CBT + CET group showed a significant reduction in cue-induced craving. However, there were no significant differences in either retention nor abstinence rates between CBT and CBT + CET in any assessment period (end-of-treatment, 1-, 6-, and 12-month follow-up). Moreover, a higher rate of relapse over a 12-month follow-up period was found in the CBT + CET group compared to the CBT group (Wald χ 2  = 4.796, p = .029).
CONCLUSIONS


Findings support and expand previous evidence by showing that a CET protocol does not increase the effectiveness of a CBT intervention for smoking cessation among treatment-seeking smokers. Moreover, this study also reveals that CET may increase risk of relapse among nicotine-dependent individuals who successfully achieve abstinence. Until the mechanisms underlying the effect of CET are identified, researchers and clinicians should be cautious when utilizing this protocol.",2019,"However, there were no significant differences in either retention nor abstinence rates between CBT and CBT + CET in any assessment period (end-of-treatment, 1-, 6-, and 12-month follow-up).","['One hundred and two smokers', 'smokers', 'treatment-seeking patients from the general population']","['CET', 'cue exposure treatment (CET', 'CET procedure in combination with a Cognitive-Behavioral Treatment (CBT', 'CBT\u202f+\u202fCET', 'CBT', 'CBT intervention']","['rate of relapse', 'risk of relapse', 'cue-induced craving', 'retention nor abstinence rates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",102.0,0.0221752,"However, there were no significant differences in either retention nor abstinence rates between CBT and CBT + CET in any assessment period (end-of-treatment, 1-, 6-, and 12-month follow-up).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Department of Psychiatry, University of Vermont, 1 S. Prospect St. UHC OH3 MS 482, Burlington, VT 05405, USA. Electronic address: ipericot@uvm.edu.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, Oviedo, 33003, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gutiérrez-Maldonado', 'Affiliation': ""Department of Personality, Assessment and Psychological Treatments, University of Barcelona, Passeig de la Vall d' Hebron 171, Barcelona, 08035, Spain.""}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.10.003']
1192,30963460,Cricoid-mental distance-based versus weight-based criteria for size selection of classic laryngeal mask airway in adults: a randomized controlled study.,"The optimal size selection of laryngeal mask airway (LMA) based on body weight is not always applicable. This study was prospectively conducted to evaluate the efficacy of cricoid-mental distance-based method versus weight-based method in optimal size selection of LMA in adults. Seventy-four patients (aged from 18 to 65) undergoing ophthalmic surgery were randomly assigned into cricoid-mental (CM) distance-based group or weight-based group to select appropriate size of LMA. The primary outcome was oropharyngeal leak pressure (OLP). Secondary outcomes included overall insertion success rate, number of insertion attempts, time to successful insertion, ease of insertion, score of fiber-optic view, peak inspiratory pressure during mechanical ventilation and postoperative pharyngolaryngeal morbidity. The OLP was significantly higher in CM distance-based group than that in weight-based group (19.38 ± 3.52 vs. 17.50 ± 3.18, P = 0.022). The successful placement at the first attempt in CM distance-based group was dramatically increased as compared with weight-based group (89.2% vs. 62.2%, P = 0.005). The overall success rate of LMA insertion in CM distance-based group was slightly increased in comparison with the weight-based group (100% vs. 91.9%, P = 0.240). There were no significant differences in score of fiber-optic view and postoperative pharyngolaryngeal morbidity between both groups (all P > 0.05). CM distance-based criteria is an alternative choice for optimizing size selection of classic LMA in adults.",2019,There were no significant differences in score of fiber-optic view and postoperative pharyngolaryngeal morbidity between both groups (all P > 0.05).,"['classic laryngeal mask airway in adults', 'Seventy-four patients (aged from 18 to 65) undergoing ophthalmic surgery', 'adults']","['cricoid-mental (CM) distance-based group or weight-based group to select appropriate size of LMA', 'laryngeal mask airway (LMA', 'Cricoid-mental distance-based versus weight-based criteria', 'cricoid-mental distance-based method versus weight-based method']","['overall success rate of LMA insertion', 'successful placement', 'OLP', 'oropharyngeal leak pressure (OLP', 'overall insertion success rate, number of insertion attempts, time to successful insertion, ease of insertion, score of fiber-optic view, peak inspiratory pressure during mechanical ventilation and postoperative pharyngolaryngeal morbidity', 'score of fiber-optic view and postoperative pharyngolaryngeal morbidity']","[{'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.12683,There were no significant differences in score of fiber-optic view and postoperative pharyngolaryngeal morbidity between both groups (all P > 0.05).,"[{'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Yiquan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Eye Trauma, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China. lzr1521@126.com.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Gan', 'Affiliation': 'Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00308-w']
1193,30964178,Developing and cross-validation of new equations to estimate fat mass in Italian population.,"OBJECTIVE


Obesity is a global burden that involves more than 500 million people. The objective of this work is to develop and cross-validate the new sex-specific equations to estimate fat mass, based on anthropometric parameters and to compare with other equations.
PATIENTS AND METHODS


We evaluated 38762 subjects by dual-energy X-ray absorptiometry (DXA) and enrolled 1434 women and 640 men, aged between 18 and 65 years. Then, we randomized 480 men and 1080 women in developing set and 160 men and 354 women in the cross-validation set. Statistical analysis as multiple regression and Bland-Altman methods were performed.
RESULTS


Sex-specific equations were created based on developing set. Then, based on the cross-validating set, these equations were validated and were observed to agree with fat mass by DXA, better than other equations, such as BAI and RFM.
CONCLUSIONS


These new sex-specific equations represent an easy tool, since they require only two circumferences, to be used in clinical practice. In the next future, these equations could be validated and refine on specific Italian sub-populations, divided by gender and age, such as the military.",2019,"Then, based on the cross-validating set, these equations were validated and were observed to agree with fat mass by DXA, better than other equations, such as BAI and RFM.
","['Italian population', '500 million people', '38762 subjects by dual-energy X-ray absorptiometry (DXA) and enrolled 1434 women and 640 men, aged between 18 and 65 years', '480 men and 1080 women in developing set and 160 men and 354 women in the cross-validation set']",[],[],"[{'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]",[],[],480.0,0.0279707,"Then, based on the cross-validating set, these equations were validated and were observed to agree with fat mass by DXA, better than other equations, such as BAI and RFM.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lorenzo', 'Affiliation': 'Department of Biomedicine and Prevention, Section of Clinical Nutrition and Nutrigenomic, University of Tor Vergata, Rome, Italy. paola.gualtieri@uniroma2.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Siclari', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gratteri', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gualtieri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merra', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Colica', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201903_17399']
1194,30946974,Prognostic Implications for Adolescents With Depression Who Drop Out of Psychological Treatment During a Randomized Controlled Trial.,"OBJECTIVE


High therapy dropout rates among adolescents have been reported, but little is known about whether dropout is associated with poor outcomes. This study aimed to examine clinical outcomes in adolescents with depression who dropped out of psychological therapy and to determine whether this varied by treatment type.
METHOD


Data were drawn from the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study, a randomized controlled trial, comparing a brief psychosocial intervention, cognitive-behavioral therapy, and short-term psychoanalytic psychotherapy in the treatment of adolescent major depression. The sample comprised 406 adolescents with a diagnosis of major depression, 169 of whom dropped out of treatment before the planned end of therapy. Primary outcome was self-report Mood and Feelings Questionnaire (MFQ); secondary outcomes were Health of the Nation Outcome Scale for Children and Adolescents, Revised Children's Manifest Anxiety Scale, Modified Leyton Obsessional Inventory, and clinical diagnosis.
RESULTS


During follow-up, there was a nonsignificant trend for dropouts to report higher depressive symptoms than completers. However, modeling showed insufficient evidence for an association between dropout and outcomes.
CONCLUSION


In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist. This challenges us to understand why adolescents stop going to therapy, how dropout should be defined, and whether what is prescribed is what is always needed.
CLINICAL TRIAL REGISTRATION INFORMATION


Improving Mood and Preventing Relapse With Psychoanalytic Psychotherapy and Cognitive Behavior Therapy; http://www.isrctn.com/; 83033550.",2019,"In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist.","['adolescents with depression who dropped out of psychological therapy', 'adolescent major depression', 'Adolescents With Depression', '406 adolescents with a diagnosis of major depression, 169 of whom dropped out of treatment before the planned end of therapy', 'Data were drawn from the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study']","['psychosocial intervention, cognitive-behavioral therapy, and short-term psychoanalytic psychotherapy']","[""self-report Mood and Feelings Questionnaire (MFQ); secondary outcomes were Health of the Nation Outcome Scale for Children and Adolescents, Revised Children's Manifest Anxiety Scale, Modified Leyton Obsessional Inventory, and clinical diagnosis"", 'depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0585661', 'cui_str': 'Health of the Nation Outcome Scale for children (assessment scale)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024720', 'cui_str': 'Manifest Anxiety Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",406.0,0.112776,"In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': ""O'Keeffe"", 'Affiliation': 'University College London, UK; Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK. Electronic address: sally.okeeffe@ucl.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'University College London, UK; Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Kelvin', 'Affiliation': 'MindEd, The Royal College of Psychiatrists, London, UK.'}, {'ForeName': 'Bernadka', 'Initials': 'B', 'LastName': 'Dubicka', 'Affiliation': 'Pennine Care NHS Foundation Trust, Lancashire, UK; University of Manchester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'University College London, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.11.019']
1195,30908139,Monitoring and Developing a Volunteer Patient Navigation Intervention to Improve Mammography Compliance in a Safety Net Hospital.,"PURPOSE


Although mammography screening is crucial for cancer detection, screening rates have been declining, particularly in patients of low socioeconomic status and minorities. We sought to evaluate and improve the compliance rates at our safety net hospital through a prospective randomized controlled trial of a volunteer-run patient navigation intervention.
METHODS


Baseline 90-day institutional mammography compliance rates were evaluated for patients who received a physician order for screening mammograms over a 1-month period. This analysis aided in the creation of a prospective randomized controlled trial of a volunteer-run patient navigation intervention to improve compliance, with 49 total participants. The primary outcome was 14-day mammography compliance rates. Secondary analysis examined the efficacy of the intervention with respect to patient demographics, prior mammography compliance, family history of cancer, beliefs on mammography, and past medical history.
RESULTS


Analysis of baseline institutional compliance revealed a 47.87% compliance rate, with the majority of compliance occurring within 14 days of order placement. The patient navigation intervention significantly improved compliance by 34% (42% in the control group, 76% in the intervention group). Additional findings included significantly improved compliance in patients who believed they had a low susceptibility to cancer, those who understood the benefits of mammography and early diagnosis, those who had a prior mammogram, those who were employed, and those with a family history of cancer.
CONCLUSION


A system to monitor compliance and intervene using patient navigation significantly improved mammography compliance of patients in a safety net hospital. The relatively straightforward design of this volunteer-based intervention makes it affordable, easily replicable, and perhaps beneficial at other institutions.",2019,"The patient navigation intervention significantly improved compliance by 34% (42% in the control group, 76% in the intervention group).","['patients who received a physician order for screening mammograms over a 1-month period', '49 total participants']","['mammography screening', 'volunteer-run patient navigation intervention', 'Volunteer Patient Navigation Intervention']","['14-day mammography compliance rates', 'mammography compliance', 'compliance', 'compliance rates', 'patient demographics, prior mammography compliance, family history of cancer, beliefs on mammography, and past medical history']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0260515', 'cui_str': 'Family history of cancer'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0455458', 'cui_str': 'Past medical history'}]",,0.0482546,"The patient navigation intervention significantly improved compliance by 34% (42% in the control group, 76% in the intervention group).","[{'ForeName': 'Ilana G', 'Initials': 'IG', 'LastName': 'Margulies', 'Affiliation': '1 New York Medical College, Valhalla, NY.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Zwillenberg', 'Affiliation': '2 NYC Health + Hospitals/Metropolitan, New York, NY.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Chadda', 'Affiliation': '2 NYC Health + Hospitals/Metropolitan, New York, NY.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Gissel', 'Affiliation': '1 New York Medical College, Valhalla, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lettera', 'Affiliation': '2 NYC Health + Hospitals/Metropolitan, New York, NY.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': '2 NYC Health + Hospitals/Metropolitan, New York, NY.'}, {'ForeName': 'Marc K', 'Initials': 'MK', 'LastName': 'Wallack', 'Affiliation': '1 New York Medical College, Valhalla, NY.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': '1 New York Medical College, Valhalla, NY.'}]",Journal of oncology practice,['10.1200/JOP.18.00424']
1196,30980514,Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis.,"OBJECTIVE


The present study was undertaken to evaluate the safety and efficacy of intravenous (IV) golimumab in patients with active psoriatic arthritis (PsA) through 1 year.
METHODS


GO-VIBRANT was a phase III, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to receive IV placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, and every 8 weeks, with placebo crossover to golimumab at weeks 24, 28, and every 8 weeks thereafter. Efficacy through week 52 was assessed using the American College of Rheumatology (ACR) ≥20%, 50%, or 70% improvement criteria (ACR20/50/70), and the Psoriasis Area and Severity Index ≥75% improvement criteria (PASI75). Radiographic progression was measured using the PsA-modified Sharp/van der Heijde score (SHS). Adverse events (AEs) were monitored through week 60.
RESULTS


The primary and major secondary end points through week 24 were achieved. At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved an ACR20 response, 58.1% and 53.6%, respectively, achieved an ACR50 response, and 38.6% and 33.9%, respectively, achieved an ACR70 response. Among patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total SHS at week 52 was -0.5 in the golimumab group and 0.8 in the placebo-crossover group. Through week 60, 50.9% of all golimumab-treated patients had ≥1 AE, and 5.2% had ≥1 serious AE. There were no opportunistic infections, 2 malignancies, and 1 death in patients treated with golimumab.
CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study. No new safety signals for IV golimumab were identified.",2020,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","['Patients with Active Psoriatic Arthritis', 'patients with active psoriatic arthritis (PsA) through 1 year', '480 adults with active PsA. Patients', 'patients with PsA']","['intravenous golimumab', 'Intravenous Golimumab', 'placebo', 'intravenous placebo', 'placebo crossover to golimumab', 'golimumab']","['ACR70 response', 'Psoriasis Area and Severity Index (PASI75); radiographic progression', 'ACR criteria (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI', 'ACR50 response', 'PASI75 response', 'total vdH-S score', 'Efficacy and Safety', 'Adverse events (AEs', 'joint and skin disease', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}]",480.0,0.512219,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","[{'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Rekalov', 'Affiliation': 'Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}]",Arthritis care & research,['10.1002/acr.23905']
1197,30961342,Influence of prevention of caffeine citrate on cytokine profile and bronchopulmonary dysplasia in preterm infants with apnea.,"BACKGROUND


This study aims to investigate the preventive effects of caffeine citrate on cytokine profile and bronchopulmonary dysplasia (BPD) in preterm infants with apnea.
METHODS


Preterm infants with apnea who were born at less than 32 weeks of gestational age and birth weight ≤1500 g were randomly divided into caffeine citrate prevention group and caffeine citrate treatment group. Preterm infants in caffeine citrate prevention group who were at risk of developing recurrent apnea were given to caffeine citrate within 8 h after birth. Those in caffeine citrate treatment group experienced apnea after birth were given to caffeine citrate for treatment. Preterm infants in both groups were treated with the same respiratory management and other conventional therapy. After drug discontinuation, levels of cytokine profile, and incidence of BPD were compared between two groups.
RESULTS


A total of 56 preterm infants were enrolled. Differences in gestational age (P=0.11) and birth weight (P=0.251) were not statistically significant. Differences in application time of caffeine citrate (P=0.356), hour of ventilator use (P=0.152), length of stay (P=0.416) and BPD morbidity (P=1.00) between two groups were not statistically significant. At birth, there were no statistically significant in levels of IL-6 (P=0.063) and IL-8 (P=0.125) between two groups. After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
CONCLUSIONS


Prevention usage of caffeine citrate in preterm infants with apnea could reduce the level of cytokine profile and the incidence of BPD.",2020,"After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
","['Preterm infants with apnea who were born at less than 32 weeks of gestational age and Birth weight≤1500 g', 'A total of fifty-six preterm infants were enrolled', 'preterm infants with apnea']","['caffeine citrate', 'caffeine citrate prevention group and caffeine citrate treatment group', 'caffeine citrate prevention', 'conventional therapy']","['risk of developing recurrent apnea', 'BPD morbidity', 'cytokine profile and bronchopulmonary dysplasia', 'apnea', 'length of stay', 'IL-8', 'birth weight', 'levels of IL-6 (P=0.001) and IL-8', 'levels of cytokine profile, and incidence of BPD', 'level of cytokine profile and the incidence of BPD', 'levels of IL-6', 'cytokine profile and bronchopulmonary dysplasia (BPD']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0054436', 'cui_str': 'caffeine citrate'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0795703', 'cui_str': 'Recurrent apnea (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",56.0,0.0188575,"After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Kou', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China - kcviva@126.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhaona', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zunjie', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhengping', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}]",Minerva pediatrica,['10.23736/S0026-4946.19.05428-8']
1198,30961368,"Physical Activity Messages for Youth with Disabilities: An Evaluation of Attitudes, Intentions, and Preferences.","There is no known research examining the use of strategic messages to motivate youth with physical disabilities (YWPD), or how to create effective messages for them. Guided by the Social Issue Advertising Believability Model (SIABM), the study aimed to: (i) examine the effectiveness of physical activity (PA) messages on YWPD's attitudes and intentions to participate in PA, and (ii) consider factors related to message effectiveness. YWPD (N = 60) were randomized to view one of three PA messages: (a) no youth, (b) non-inclusive, and (c) targeted. Attitudes and intentions to participate in PA were assessed at baseline and immediately following viewing one of the three messages. Participants also evaluated the messages in terms of relevance, believability, attention, and attitudes. Repeated measures ANOVA and median split analyses indicated that attitudes toward PA increased after message viewing for participants with low baseline attitudes, but decreased for participants with high baseline attitudes. No significant changes in intentions emerged. The targeted message was most preferred and evaluated as most believable. Attention paid to the message was the only significant predictor of intention to participate in PA post-viewing (p = .001). PA campaigns should consider being inclusive of YWPD with low attitudes and intentions to engage in PA when developing messages.",2020,"Repeated measures ANOVA and median split analyses indicated that attitudes toward PA increased after message viewing for participants with low baseline attitudes, but decreased for participants with high baseline attitudes.",['Youth with Disabilities'],"['YWPD', 'Physical Activity Messages', 'physical activity (PA) messages']","['relevance, believability, attention, and attitudes', 'Attitudes and intentions to participate in PA', 'attitudes toward PA']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",60.0,0.017533,"Repeated measures ANOVA and median split analyses indicated that attitudes toward PA increased after message viewing for participants with low baseline attitudes, but decreased for participants with high baseline attitudes.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Larocca', 'Affiliation': 'School of Kinesiology and Health Science, York University.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arbour-Nicitopoulos', 'Affiliation': 'Faculty of Kinesiology & Physical Education, University of Toronto.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Latimer-Cheung', 'Affiliation': ""School of Kinesiology and Health, Queen's University.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bassett-Gunter', 'Affiliation': 'School of Kinesiology and Health Science, York University.'}]",Health communication,['10.1080/10410236.2019.1598746']
1199,30856418,On the malleability of selective trust.,"Although much research has explored the cues that young children use to determine informant credibility, little research has examined whether credibility judgments can change over time as a function of children's language environment. This study explored whether changes in the syntactic complexity of adults' testimony shifts 4- and 5-year-old children's (N = 42) credibility and learning judgments. Children from lower-socioeconomic status (SES) backgrounds were randomly assigned to hear a high proportion of complex language (the passive voice) or simpler language (the active voice) during 10 days of book-reading interactions with adult experimenters. Before and after the book-reading sessions, children's learning preferences for informants who used passive versus active voice were measured. Exposure to the complex passive voice led children to use syntactic complexity as a cue to make inferences about who to learn from, whereas active voice exposure resulted in no such shift. Implications for the role of the language environment in children's selective trust are discussed.",2019,"Before and after the book-reading sessions, children's learning preferences for informants who used passive versus active voice were measured.","['young children', 'Children from lower-socioeconomic status (SES) backgrounds', ""adults' testimony shifts 4- and 5-year-old children's (N\u202f=\u202f42) credibility and learning judgments""]",['complex language (the passive voice) or simpler language (the active voice'],[],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",[],,0.0193102,"Before and after the book-reading sessions, children's learning preferences for informants who used passive versus active voice were measured.","[{'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Leech', 'Affiliation': 'Graduate School of Education, Harvard University, Cambridge, MA 02138, USA. Electronic address: kathryn_leech@gse.harvard.edu.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Haber', 'Affiliation': 'Wheelock College of Education and Human Development, Boston University, Boston, MA 02215, USA.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Arunachalam', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, New York, NY 10012, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Kurkul', 'Affiliation': 'School of Education and Social Policy, Merrimack College, North Andover, MA 01845, USA.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Corriveau', 'Affiliation': 'Wheelock College of Education and Human Development, Boston University, Boston, MA 02215, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.01.013']
1200,30887607,Anti-fracture efficacy of zoledronate in subgroups of osteopenic postmenopausal women: secondary analysis of a randomized controlled trial.,"BACKGROUND


We recently reported that the administration of zoledronate every 18 months to osteopenic older women reduces the incidence of fractures.
OBJECTIVE


Here, we present a more detailed analysis of that trial to determine whether baseline clinical characteristics impact on the anti-fracture efficacy of this intervention.
METHODS


This is a prospective, randomized, placebo-controlled, double-blind trial in osteopenic postmenopausal women aged ≥ 65 years, to determine the anti-fracture efficacy of zoledronate. 2000 women were recruited using electoral rolls and randomized to receive 4 infusions of either zoledronate 5 mg or normal saline, at 18-month intervals. Each participant was followed for 6 years. Calcium supplements were not supplied.
RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001). There were no significant interactions between baseline variables (age, anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk) and the treatment effect. In particular, the reduction in fractures appeared to be independent of baseline fracture risk, and numbers needed to treat (NNT) to prevent one woman fracturing were not significantly different across baseline fracture risk tertiles.
CONCLUSIONS


The present analyses indicate that the decrease in fracture numbers is broadly consistent across this cohort. The lack of relationship between NNTs and baseline fracture risk calls into question the need for BMD measurement and precise fracture risk assessment before initiating treatment in older postmenopausal women.",2019,"RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001).","['2000 women were recruited using electoral rolls', 'older postmenopausal women', 'subgroups of osteopenic postmenopausal women', 'osteopenic older women', 'osteopenic postmenopausal women aged\xa0≥']","['zoledronate 5\xa0mg or normal saline', 'zoledronate', 'Calcium supplements', 'placebo']","['Fragility fractures', 'fracture numbers', 'anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0302113', 'cui_str': 'Fragility, function (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2000.0,0.521824,"RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001).","[{'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Garratt', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Wiessing', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bastin', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of internal medicine,['10.1111/joim.12901']
1201,31713082,No superiority of dextrose injections over placebo injections for Osgood-Schlatter disease: a prospective randomized double-blind study.,"PURPOSE


Osgood-Schlatter disease (OSD) is a traction apophysitis of the tibial tuberosity. Patellar tendinopathy and deep infrapatellar bursitis have recently been shown to contribute to pain in patients with OSD. We compared the effects of dextrose injection and saline injection.
METHODS


We performed a clinical trial from April 2012 to January 2016 and included 49 knees from 37 boys and 1 girl (mean age, 12.3 ± 1.1 years) for whom conventional conservative therapy for > 1 month was ineffective. They were randomly assigned to receive double-blind injections of 1% lidocaine (1 mL) with 20% dextrose (1 mL; dextrose group) or 1% lidocaine (1 mL) with saline (1 mL; saline group). Injections were administered monthly for 3 months by a single investigator. The Victorian Institute of Sport Assessment (VISA) score was used to evaluate anterior knee pain.
RESULTS


Overall, 43 knees were included; 6 knees were lost to follow-up. The mean pre-injection VISA scores in the dextrose and saline groups were 58.7 ± 18.3 and 63.4 ± 16.4, respectively. No significant differences were found between the two groups at any time point. The mean VISA score before injections significantly increased at the 1-month follow-up in both groups (P < .01). The injection had no adverse effects.
CONCLUSIONS


We were not able to show the efficacy of dextrose injections compared to that of saline.
LEVEL OF EVIDENCE


Randomized controlled trial. Level I.",2020,The mean VISA score before injections significantly increased at the 1-month follow-up in both groups (P < .01).,"['April 2012 to January 2016 and included 49 knees from 37 boys and 1 girl (mean age, 12.3\u2009±\u20091.1\xa0years) for whom conventional conservative therapy for\u2009>\u20091\xa0month was ineffective', 'Osgood-Schlatter disease', 'patients with OSD', '43 knees were included; 6 knees were lost to follow-up']","['placebo injections', 'lidocaine (1\xa0mL) with 20% dextrose (1\xa0mL; dextrose group) or 1% lidocaine', 'dextrose injections', 'saline', 'dextrose injection and saline injection']","['Victorian Institute of Sport Assessment (VISA) score', 'mean pre-injection VISA scores', 'mean VISA score']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0029376', 'cui_str': 'Osgood-Schlatter Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}]",,0.65929,The mean VISA score before injections significantly increased at the 1-month follow-up in both groups (P < .01).,"[{'ForeName': 'Junsuke', 'Initials': 'J', 'LastName': 'Nakase', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan. nakase1007@yahoo.co.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takata', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Shimozaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, 920-8641, Japan.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03297-2']
1202,31712950,Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial.,"BACKGROUND AND OBJECTIVES


To investigate the feasibility of delivering a functional exercise-based prehabilitation intervention and its effects on postoperative length of hospital stay, preoperative physical functioning and health-related quality of life in elective colorectal surgery.
MATERIALS AND METHODS


In this randomised controlled feasibility trial, 22 elective colorectal surgery patients were randomly assigned to exercise prehabilitation (n = 11) or standard care (n = 11). Feasibility of delivering the intervention was assessed based on recruitment and compliance to the intervention. Impact on postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life were also assessed.
RESULTS


Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery. Of those who were eligible, approximately 18% consented to the trial. Median length of hospital stay was 8 [range 6-27] and 10 [range 5-12] days respectively for the standard care and prehabilitation groups. Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
CONCLUSIONS


Despite prehabilitation appearing to convey positive benefits on physical functioning, short surgical wait times and patient engagement represent major obstacles to implementing exercise prehabilitation programmes in colorectal cancer patients.",2020,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
","['colorectal cancer patients', 'patients scheduled for elective colorectal surgery', 'Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery', '22 elective colorectal surgery patients']","['novel exercise prehabilitation programme', 'standard care', 'exercise prehabilitation', 'functional exercise-based prehabilitation intervention']","['Median length of hospital stay', 'stair climb test and 6-min walk test', 'postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life', 'postoperative length of hospital stay, preoperative physical functioning and health-related quality of life']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",22.0,0.0883603,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Northgraves', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Arunachalam', 'Affiliation': 'General Surgery, Pinderfields Hospital, Wakefield, UK.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'Department of Biomedical Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Marshall', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hartley', 'Affiliation': 'Academic Surgical Unit, Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'MacFie', 'Affiliation': 'Combined Gastroenterology Research Unit, Scarborough Hospital, Scarborough, UK.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Vince', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK. Rebecca.vince@hull.ac.uk.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05098-0']
1203,31714582,Efficacy of α-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.,"CONTEXT


Pretreatment with α-adrenergic receptor blockers is recommended to prevent hemodynamic instability during resection of a pheochromocytoma or sympathetic paraganglioma (PPGL).
OBJECTIVE


To determine which type of α-adrenergic receptor blocker provides the best efficacy.
DESIGN


Randomized controlled open-label trial (PRESCRIPT; ClinicalTrials.gov NCT01379898).
SETTING


Multicenter study including 9 centers in The Netherlands.
PATIENTS


134 patients with nonmetastatic PPGL.
INTERVENTION


Phenoxybenzamine or doxazosin starting 2 to 3 weeks before surgery using a blood pressure targeted titration schedule. Intraoperative hemodynamic management was standardized.
MAIN OUTCOME MEASURES


Primary efficacy endpoint was the cumulative intraoperative time outside the blood pressure target range (ie, SBP >160 mmHg or MAP <60 mmHg) expressed as a percentage of total surgical procedure time. Secondary efficacy endpoint was the value on a hemodynamic instability score.
RESULTS


Median cumulative time outside blood pressure targets was 11.1% (interquartile range [IQR]: 4.3-20.6] in the phenoxybenzamine group compared to 12.2% (5.3-20.2)] in the doxazosin group (P = .75, r = 0.03). The hemodynamic instability score was 38.0 (28.8-58.0) and 50.0 (35.3-63.8) in the phenoxybenzamine and doxazosin group, respectively (P = .02, r = 0.20). The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P = .68). There was no mortality after 30 days.
CONCLUSIONS


The duration of blood pressure outside the target range during resection of a PPGL was not different after preoperative treatment with either phenoxybenzamine or doxazosin. Phenoxybenzamine was more effective in preventing intraoperative hemodynamic instability, but it could not be established whether this was associated with a better clinical outcome.",2020,"The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P=0.68).","['134 patients with non-metastatic PPGL', 'Multicenter study including 9 centers in The Netherlands']","['phenoxybenzamine', 'Phenoxybenzamine', 'doxazosin', 'α-blockers', 'phenoxybenzamine or doxazosin', 'α-adrenergic receptor blockers', 'phenoxybenzamine and doxazosin']","['mortality', '30-day cardiovascular complication rate', 'cumulative intraoperative time outside the blood pressure target range (i.e., SBP >160 mmHg or MAP <60 mmHg) expressed as a percentage of total surgical procedure time', 'duration of blood pressure', 'hemodynamic instability score', 'intraoperative hemodynamic instability', 'Median cumulative time outside blood pressure targets']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0031441', 'cui_str': 'Phenoxybenzamine'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",134.0,0.097698,"The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P=0.68).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Buitenwerf', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thamara E', 'Initials': 'TE', 'LastName': 'Osinga', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henri J L M', 'Initials': 'HJLM', 'LastName': 'Timmers', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacques W M', 'Initials': 'JWM', 'LastName': 'Lenders', 'Affiliation': 'Department of Internal Medicine, Section of Vascular Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Elisabeth M W', 'Initials': 'EMW', 'LastName': 'Eekhoff', 'Affiliation': 'Department of Internal Medicine, Endocrinology Section, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Harm R', 'Initials': 'HR', 'LastName': 'Haak', 'Affiliation': 'Department of Internal Medicine, Máxima Medical Center, Eindhoven, The Netherlands.'}, {'ForeName': 'Eleonora P M', 'Initials': 'EPM', 'LastName': 'Corssmit', 'Affiliation': 'Department of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter H L T', 'Initials': 'PHLT', 'LastName': 'Bisschop', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerlof D', 'Initials': 'GD', 'LastName': 'Valk', 'Affiliation': 'Department of Endocrine Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ronald Groote', 'Initials': 'RG', 'LastName': 'Veldman', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Robin P F', 'Initials': 'RPF', 'LastName': 'Dullaart', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thera P', 'Initials': 'TP', 'LastName': 'Links', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Magiel F', 'Initials': 'MF', 'LastName': 'Voogd', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Götz J K G', 'Initials': 'GJKG', 'LastName': 'Wietasch', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michiel N', 'Initials': 'MN', 'LastName': 'Kerstens', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz188']
1204,30846465,Analysis of the MILES cohort reveals determinants of disease progression and treatment response in lymphangioleiomyomatosis.,"INTRODUCTION


The Multicenter International Lymphangioleiomyomatosis (LAM) Efficacy of Sirolimus (MILES) trial revealed that sirolimus stabilised lung function in patients with moderately severe LAM. The purpose of this study was to further examine the MILES cohort for the effects of racial, demographic, clinical and physiological patient characteristics on disease progression and treatment response in LAM.
METHODS


MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian), bronchodilator responsiveness (present/absent), initial forced expiratory volume in 1 s (FEV 1 ; 51-70%  versus  ≤50% predicted) and tuberous sclerosis complex (TSC) association (yes/no). A linear mixed effects model was used to compare slope differences, and nonparametric tests were used to compare medians and proportions between treatment groups in each stratum.
RESULTS


In the MILES placebo group, pre-menopausal patients declined 5-fold faster than post-menopausal patients (mean±se FEV 1  slope -17±3  versus  -3±3 mL·month -1 ; p=0.003). Upon treatment with sirolimus, both the pre-menopausal (-17±3  versus  -1±2 mL·month -1 ; p<0.0001) and post-menopausal patients (-3±3  versus  6±3 mL·month -1 ; p=0.04) exhibited a beneficial response in mean±se FEV 1  slope compared with the placebo group. Race, LAM subtype, bronchodilator responsiveness or baseline FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group. Menopausal status and race had differential effects on the adverse event profile of sirolimus. Baseline serum vascular endothelial growth factor (VEGF)-D >600 pg·mL -1  identified subgroups of patients who were more likely to decline on placebo and respond to treatment with sirolimus.
CONCLUSIONS


In LAM patients, treatment with sirolimus is beneficial regardless of menopausal status, race, bronchodilator responsiveness, baseline FEV 1  or TSC association. Serum VEGF-D and menopausal status can help inform therapeutic decisions.",2019,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"['patients with moderately severe LAM', 'MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian']","['sirolimus', 'MILES placebo', 'placebo', 'Sirolimus (MILES', 'Lymphangioleiomyomatosis (LAM']","['rate of disease progression', 'Baseline serum vascular endothelial growth factor (VEGF)-D ', 'Serum VEGF-D and menopausal status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0751674', 'cui_str': 'Lymphangioleiomyomatosis'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.156081,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"[{'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Hye-Seung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Young', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lianne G', 'Initials': 'LG', 'LastName': 'Singer', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Barker', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Chapman', 'Affiliation': 'Cleveland Clinic, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Brantly', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stocks', 'Affiliation': 'University of Texas Health Sciences Center, Tyler, TX, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Lynch', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Downey', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'Taveira-DaSilva', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Setchell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'McCormack', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02066-2018']
1205,30904332,Incorporating loading variability into in vitro injury analyses and its effect on cumulative compression tolerance in porcine cervical spine units.,"During repetitive movement, low-back loading exposures are inherently variable in magnitude. The current study aimed to investigate how variation in successive compression exposures influences cumulative load tolerance in the spine. Forty-eight porcine cervical spine units were randomly assigned to one of six combinations of mean peak compression force (30%, 50%, 70% of the predicted tolerance) and loading variation (consistent peak amplitude, variable peak amplitude). Following preload and passive range-of-motion tests, specimens were positioned in a neutral posture and then cyclically loaded in compression until failure occurred or the maximum 12 h duration was reached. Specimens were dissected to classify macroscopic injury and measurements of cumulative load, cycles, and height loss sustained at failure were calculated. Statistical comparisons were made between loading protocols within each normalized compression group. A significant loading variation × compression interaction was demonstrated for cumulative load (p = 0.026) and cycles to failure (p = 0.021). Cumulative compression was reduced under all normalized compression loads (30% p = 0.016; 50% p = 0.030; 70% p = 0.020) when variable loading was incorporated. The largest reduction was by 33% and occurred in the 30% compression group. The number of sustained cycles was reduced by 31% (p = 0.017), 72% (p = 0.030), and 76% (p = 0.009) under normalized compression loads of 30%, 50%, and 70%, respectively. These findings suggest that variation in compression exposures interact to reduce cumulative compression tolerance of the spine and could elevate low-back injury risk during time-varying repetitive tasks.",2019,"The number of sustained cycles was reduced by 31% (p = 0.017), 72% (p = 0.030), and 76% (p = 0.009) under normalized compression loads of 30%, 50%, and 70%, respectively.","['porcine cervical spine units', 'Forty-eight porcine cervical spine units']",[],"['cumulative load', 'mean peak compression force', 'number of sustained cycles', 'normalized compression loads', 'cumulative compression tolerance', 'Cumulative compression']","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",48.0,0.0850802,"The number of sustained cycles was reduced by 31% (p = 0.017), 72% (p = 0.030), and 76% (p = 0.009) under normalized compression loads of 30%, 50%, and 70%, respectively.","[{'ForeName': 'Jackie D', 'Initials': 'JD', 'LastName': 'Zehr', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Liana M', 'Initials': 'LM', 'LastName': 'Tennant', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jack P', 'Initials': 'JP', 'LastName': 'Callaghan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada. Electronic address: jack.callaghan@uwaterloo.ca.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.03.011']
1206,30928162,Could Differences in Treatment Between Trial Arms Explain the Reduction in Prostate Cancer Mortality in the European Randomized Study of Screening for Prostate Cancer?,"BACKGROUND


Differential treatment between trial arms has been suggested to bias prostate cancer (PC) mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
OBJECTIVE


To quantify the contribution of treatment differences to the observed PC mortality reduction between the screening arm (SA) and the control arm (CA).
DESIGN, SETTING, AND PARTICIPANTS


A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes measurements were observed and estimated numbers of PC deaths by treatment allocation in the SA and CA, respectively. Primary treatment allocation was modeled using multinomial logistic regression adjusting for center, age, year, prostate-specific antigen, grade group, and tumor-node-metastasis stage. For each treatment, logistic regression models were fitted for risk of PC death, separately for the SA and CA, and using the same covariates as for the treatment allocation model. Treatment probabilities were multiplied by estimated PC death risks for each treatment based on one arm, and then summed and compared with the observed number of deaths.
RESULTS AND LIMITATIONS


The difference between the observed and estimated treatment distributions (hormonal therapy, radical prostatectomy, radiotherapy, and active surveillance/watchful waiting) in the two arms ranged from -3.3% to 3.3%. These figures, which represent the part of the treatment differences between arms that cannot be explained by clinicopathological differences, are small compared with the observed differences between arms that ranged between 7.2% and 10.1%. The difference between the observed and estimated numbers of PC deaths among men with PC was 0.05% (95% confidence interval [CI] -0.1%, 0.2%) when applying the CA model to the SA, had the two groups received identical primary treatment, given their clinical characteristics. When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%). Consistency of the results of the models demonstrates the robustness of the modeling approach. As the observed difference between trial arms was 4.2%, our findings suggest that differential treatment explains only a trivial proportion of the main findings of ERSPC. A limitation of the study is that only data on primary treatment were available.
CONCLUSIONS


Use of prostate-specific antigen remains the predominant explanation for the reduction in PC mortality seen in the ERSPC trial and is not attributable to differential treatment between trial arms.
PATIENT SUMMARY


This study shows that prostate cancer deaths in the European screening trial (European Randomized Study of Screening for Prostate Cancer) were prevented because men were diagnosed and treated earlier through prostate-specific antigen screening, and not because of different, or better, treatment in the screening arm compared with the control arm.",2019,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).",['A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up'],[],"['numbers of PC deaths', 'PC deaths', 'PC death risks', 'radical prostatectomy, radiotherapy, and active surveillance/watchful waiting', 'PC mortality reduction', 'Prostate Cancer Mortality']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",14136.0,0.0787604,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).","[{'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'School of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Urology, Gothenborg, Sweden. Electronic address: jonas@urol.se.'}]",European urology,['10.1016/j.eururo.2019.03.010']
1207,31820836,The effect of web-based education on Pap smear behaviours of teachers.,"OBJECTIVE


Web-based education would be useful for gaining health-related behaviours. The aim of the study was to determine the effect of web-based education on Pap smear behaviours of teachers.
METHODS


The study was an experimental-control groups with a longitudinal type. The sample consisted of 1,290 teachers (experimental: 678, control: 612). The educational videos about cervical cancer and Pap smear test were sent to the experimental group via the web. Three months later, the teachers in both groups were contacted by telephone and asked whether they have a Pap smear test or not, reasons for not having it and test results. A qualitative interview was conducted with 20 teachers in the experimental group to evaluate the web-based education.
RESULTS


At the beginning of the study, 25.9% of the teachers in both groups had a Pap smear test. After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%). According to the result of pathology, in the control group cervical cancer (n = 1), in the experimental group CIN1 (n = 1) and HPV53 (n = 1) were diagnosed.
CONCLUSION


The web-based education was found to be effective in Pap smear behaviours of teachers.",2020,"After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%).","['1,290 teachers (experimental: 678, control: 612', 'Pap smear behaviours of teachers']","['HPV53', 'web-based education']",['Pap smear test'],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0079104', 'cui_str': 'Cervical Smears'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",1290.0,0.0180377,"After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%).","[{'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Karakuş Selçuk', 'Affiliation': 'Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yanikkerem', 'Affiliation': 'Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}]",European journal of cancer care,['10.1111/ecc.13202']
1208,30938299,"Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial.","BACKGROUND


Maternal tetanus, diphtheria, and acellular pertussis (Tdap) vaccination offers protection for neonates against clinical pertussis until primary vaccinations, but maternal antibodies also interfere with infants' immune responses to primary vaccinations. We investigated the effect of maternal Tdap vaccination on the pertussis antibody responses of infants starting primary vaccinations at age 3 months.
METHODS


In an open-label, parallel, randomised, controlled trial, pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group). All term-born infants were vaccinated with the diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine at 3 months, 5 months, and 11 months. Randomisation was done using a number generator in a 1:1 ratio and with sealed envelopes. Participants and clinical trial staff were not masked, but laboratory technicians were unaware of study group assignments. The primary endpoint was serum IgG pertussis toxin antibody concentrations at age 3 months. Cord blood and infant blood samples were collected at age 2 months, 3 months, 6 months, 11 months, and 12 months. Analysis was done by modified intention to treat with all randomly assigned participants in case a laboratory result was available. This trial is registered with ClinicaltTrialsRegister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314). The trial is now closed to new participants.
FINDINGS


Between Jan 16, 2014, and March 4, 2016, 118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group. The geometric mean concentration (GMC) of pertussis toxin antibodies were higher in infants in the maternal Tdap group than in the control group infants at age 3 months (GMC ratio 16·6, 95% CI 10·9-25·2) and also significantly higher compared with control infants at age 2 months. After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group. No safety issues after maternal Tdap vaccination were encountered.
INTERPRETATION


In view of the high pertussis toxin antibody concentrations at age 3 months, maternal vaccination supports a delay of the first pertussis vaccination in infants until at least age 3 months. Maternal antibody interference affects antibody concentrations after primary and booster vaccinations. The clinical consequences of this interference remain to be established.
FUNDING


The Dutch Ministry of Health, Welfare, and Sport.",2019,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","['118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group', 'infants starting primary vaccinations at age 3 months', 'pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received', 'infants aged up to 12 months in the Netherlands', 'Between Jan 16, 2014, and March 4, 2016']","['maternal Tdap vaccination', 'diphtheria, and acellular pertussis (Tdap) vaccination', 'Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group', 'diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine']","['Maternal antibody interference affects antibody concentrations', 'antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin', 'serum IgG pertussis toxin antibody concentrations', 'geometric mean concentration (GMC) of pertussis toxin antibodies', 'Cord blood and infant blood samples']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}]","[{'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",118.0,0.177939,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, Netherlands.'}, {'ForeName': 'Florens G A', 'Initials': 'FGA', 'LastName': 'Versteegh', 'Affiliation': ""University Groningen, University Medical Centre Groningen/Beatrix Children's Hospital, Groningen, Netherlands.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van de Kassteele', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30717-5']
1209,30928882,"Words hurt: Political rhetoric, emotions/affect, and psychological well-being among Mexican-origin youth.","We examined the effect of political rhetoric on the targets of that rhetoric. Drawing from scholarship on anti-Mexican and anti-immigrant rhetoric found readily in various media and scholarship on emotions, we tested four hypotheses. Hypotheses 1 and 2 predicted that positive and negative political rhetoric would increase and decrease positive and negative emotions, respectively. Hypotheses 3 and 4 then predicted that emotional responses to positive or negative political rhetoric would influence perceived stress, subjective health, and subjective well-being. Data collection occurred between August 2016 and June 2017 at a university in California. A sample of 280 Mexican-origin youth, defined broadly as having at least one ancestor born in Mexico or the participant themselves born in Mexico, participated in an experiment where they were randomly assigned to one of three study conditions: viewing (1) positive or (2) negative political rhetoric about immigrants and Latinos in general, or (3) neutral rhetoric as a control condition before providing qualitative responses to open-ended questions and completing measures of positive and negative affect, perceived stress, subjective health, and subjective well-being. Qualitative responses indicated that negative and positive political rhetoric elicited a range of negative emotions and positive emotions, respectively. Quantitative analysis with independent samples t-tests, ANOVA, and linear regression models found that negative political rhetoric elicited higher negative affect than positive and neutral rhetoric, and positive rhetoric elicited higher positive affect than negative and neutral rhetoric. Negative emotional responses, in turn, were associated with participants' higher perceived stress, lower subjective health and lower subjective well-being. Conversely, positive emotional responses were associated with lower perceived stress, higher subjective health, and higher subjective well-being. Positive political rhetoric, by eliciting positive emotions, can have a salubrious effect. Altogether, these findings suggest that political rhetoric matters for the targets of that rhetoric.",2019,"Negative emotional responses, in turn, were associated with participants' higher perceived stress, lower subjective health and lower subjective well-being.","['August 2016 and June 2017\u202fat a university in California', '280 Mexican-origin youth, defined broadly as having at least one ancestor born in Mexico or the participant themselves born in Mexico, participated in an experiment']","['viewing (1) positive or (2) negative political rhetoric about immigrants and Latinos in general, or (3) neutral rhetoric as a control condition']","['Negative emotional responses', 'positive emotional responses', 'positive and negative emotions']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1277462', 'cui_str': 'Born in Mexico'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0255229,"Negative emotional responses, in turn, were associated with participants' higher perceived stress, lower subjective health and lower subjective well-being.","[{'ForeName': 'Leo R', 'Initials': 'LR', 'LastName': 'Chavez', 'Affiliation': 'Professor, Department of Anthropology, University of California, 3151 Social Science Plaza, Irvine, CA 92697-5100, USA. Electronic address: lchavez@uci.edu.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Campos', 'Affiliation': 'Professor, Department of Chicano/Latino Studies, University of California, 3151 Social Science Plaza, Irvine, CA 92697-5100, USA. Electronic address: bcampos@uci.edu.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Corona', 'Affiliation': 'Graduate Student, Department of Psychology and Social Behavior, University of California, 4201 Social and Behavioral Sciences Gateway, Irvine, CA 92697-7085, USA. Electronic address: kcorona1@uci.edu.'}, {'ForeName': 'Daina', 'Initials': 'D', 'LastName': 'Sanchez', 'Affiliation': 'Graduate Student, Department of Anthropology, University of California, 3151 Social Science Plaza, Irvine, CA 92697-5100, USA. Electronic address: dainas@uci.edu.'}, {'ForeName': 'Catherine Belyeu', 'Initials': 'CB', 'LastName': 'Ruiz', 'Affiliation': 'Undergraduate Research Assistant, Department of Anthropology, University of California, 3151 Social Science Plaza, Irvine, CA 92697-5100, USA. Electronic address: catherine.belyeu.ruiz@gmail.com.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.008']
1210,31714253,Cost Per Participant Recruited From Rural and Remote Areas Into a Smoking Cessation Trial Via Online or Traditional Strategies: Observational Study.,"BACKGROUND


Rural and remote residents are more likely to smoke than those who live in major cities; however, recruitment of research participants from rural and remote areas can be challenging. The cost per participant recruited from rural and remote areas via online (eg, social media) and traditional strategies (eg, print) has implications for researchers on how to allocate resources to maximize the number of participants recruited. Participant characteristics such as demographics, financial stress, mental health, and smoking-related factors may be associated with recruitment method (ie, online vs traditional), and so it is important to understand whether certain subgroups are more likely to be recruited via a particular strategy.
OBJECTIVE


This study aimed to determine the cost per participant recruited and examine whether characteristics such as demographics, financial stress, mental health, and smoking-related factors may be associated with the recruitment method (ie, online vs traditional).
METHODS


Participants were recruited into a randomized trial that provided smoking cessation support. Eligible participants were aged 18 years or older; used tobacco daily; had access to video communication software, internet, and telephone; had an email address; and lived in a rural or remote area of New South Wales, Australia. This study describes the natural (observed) experience of recruiting participants via online and traditional methods into a smoking cessation trial.
RESULTS


Over 17 months, 655 participants were recruited into the smoking cessation trial. A total of 88.7% (581/655) of the participants were recruited via online methods. Moreover, 1.8% (12/655) of the participants were recruited from remote locations and none from very remote areas. The cost per participant recruited by the various online strategies ranged from Aus $7.29 (US $4.96, £4.09, and €4.43) for Gumtree, a local online classified website, to Aus $128.67 (US $87.63, £72.20, and €78.28) for email. The cost per participant recruited using traditional strategies ranged from Aus $0 (US $0, £0, and €0) for word of mouth to Aus $3990.84 (US $2757.67, £2227.85, and €2477.11) for telephone. Women had greater odds of being recruited via online methods than men (odds ratio 2.50, 95% CI 1.42-4.40). No other characteristics were associated with the recruitment method.
CONCLUSIONS


The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies. Women have greater odds of being recruited via online strategies into rural smoking cessation trials.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000514303; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372584&isReview=true.",2019,"The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies.","['Participants', 'Eligible participants were aged 18 years or older; used tobacco daily; had access to video communication software, internet, and telephone; had an email address; and lived in a rural or remote area of New South Wales, Australia', 'Rural and remote residents', '655 participants were recruited into the smoking cessation trial', 'Cost Per Participant Recruited From Rural and Remote Areas Into a Smoking Cessation Trial']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",[],[],655.0,0.119921,"The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, Australia.'}]",Journal of medical Internet research,['10.2196/14911']
1211,31816103,Using stakeholder perspectives to guide systematic adaptation of an autism mental health intervention for Latinx families: A qualitative study.,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families. Recommendations were collected through focus groups with therapists (n = 17) and semi-structured interviews with Latinx parents (n = 29). Relevant themes were identified through a rapid assessment analysis process and thematic coding of interviews. Adaptations were classified according to the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to facilitate fit, acceptability, and sustained implementation of AIM HI and classify the content, nature, and goals of the adaptations. Recommended adaptations were classified through FRAME as tailoring training and intervention materials, changing packaging or materials, extending intervention pacing, and integrating supplemental training strategies. Goals for adaptations included improving fit for stakeholders, increasing parent engagement, and enhancing intervention effectiveness. The current study illustrates the process of embedding an iterative process of intervention adaptation within a hybrid effectiveness-implementation trial. The next steps in this study are to integrate findings with implementation process data from the parent trial to develop a cultural enhancement to AIM HI and test the enhancement in a Hybrid Type 3 implementation-effectiveness trial.",2020,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","['publicly funded mental health services', 'autism mental health intervention for Latinx families']",['Individualized Mental Health Intervention'],[],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],,0.0324744,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","[{'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Hurwich-Reiss', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Blanche', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}]",Journal of community psychology,['10.1002/jcop.22296']
1212,31363961,Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial.,"BACKGROUND


Weight regain after bariatric surgery often starts after 1-2 y, but studies evaluating strategies to prevent weight regain are lacking. The aim of this intervention was to evaluate the efficacy of a 2-y-group-based lifestyle intervention starting approximately 2 y after Roux-en-Y gastric bypass (RYGB) compared with usual care on weight regain and related metabolic risk factors.
METHODS


A total of 165 patients with a mean of 21 months (range 14-32) after RYGB were randomized to a lifestyle intervention group (LIG) or a usual care group (UCG). Of the 165 participants 86% completed the study. The LIG was offered 16 group meetings over 2 y with focus on healthy diet, physical activity, and behavioural strategies to prevent weight regain, in addition to usual care.
RESULTS


Mean (SD) total weight loss at study start was 30.1 ± 8.2%, while weight regain during the intervention was 4.9 ± 7.4 and 4.6 ± 9.2% in the LIG and UCG, respectively (P = 0.84). There were no differences in metabolic risk factors between the groups. The LIG participants attended 8 ± 4 group meetings, with no difference in weight regain between participants with high compared to lower participation. In all the participants, a positive association between weight increase from nadir to study start and weight regain during the intervention was found. Participants who reported physical activity ≥ 150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
CONCLUSION


We found no difference in weight regain between LIG and UCG.",2019,"150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
","['165 participants 86% completed the study', 'Participants who reported physical activity\u2009≥', '165 patients with a mean of 21\xa0months (range 14-32) after RYGB']","['2-y-group-based lifestyle intervention starting approximately 2\xa0y after Roux-en-Y gastric bypass (RYGB', 'lifestyle intervention group (LIG) or a usual care group (UCG', 'Lifestyle Intervention']","['Mean (SD) total weight loss', 'metabolic risk factors', 'weight regain']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",165.0,0.0321828,"150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
","[{'ForeName': 'Susanna E', 'Initials': 'SE', 'LastName': 'Hanvold', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway. susanna@hanvold.no.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elin B', 'Initials': 'EB', 'LastName': 'Løken', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Hjartåker', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Klungsøyr', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department for Research and Education, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Risstad', 'Affiliation': 'Department of Endocrinology, Morbid Obesity and Preventive Medicine, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Endocrinology, Morbid Obesity and Preventive Medicine, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",Obesity surgery,['10.1007/s11695-019-04109-7']
1213,30937667,Why Content and Cognition Matter: Integrating Conceptual Knowledge to Support Simulation-Based Procedural Skills Transfer.,"BACKGROUND


Curricular constraints require being selective about the type of content trainees practice in their formal training. Teaching trainees procedural knowledge about ""how"" to perform steps of a skill along with conceptual knowledge about ""why"" each step is performed can support skill retention and transfer (i.e., the ability to adapt knowledge to novel problems). However, how best to organize how and why content for procedural skills training is unknown.
OBJECTIVES


We examined the impact of different approaches to integrating why and how content on trainees' skill retention and transfer of simulation-based lumbar puncture (LP).
DESIGN AND PARTICIPANTS


We randomized medical students (N = 66) to practice LP for 1 h using one of three videos. One video presented only the how content for LP (Procedural Only). Two other videos presented how and why content (e.g., anatomy) in two ways: Integrated in Sequence, with why content followed by how content, or Integrated for Causation, with how and why content integrated throughout.
MAIN MEASURES


Pairs of blinded raters scored participants' retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge.
KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01). Further, the Integrated for Causation group performed significantly better on transfer than the Integrated in Sequence group (p < 0.01), again mediated by improved conceptual knowledge. We observed no mediation of participants' skill retention (all p > 0.01).
CONCLUSIONS


When teaching supports cognitive integration of how and why content, trainees are able to transfer learning to new problems because of their improved conceptual understanding. Instructional designs for procedural skills that integrate how and why content can help educators optimize what trainees learn from each repetition of practice.",2019,"KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).",['We randomized medical students (N\u2009=\u200966) to'],"['simulation-based lumbar puncture (LP', 'practice LP']","["" retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge"", ""participants' skill retention"", 'conceptual knowledge']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0158405,"KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).","[{'ForeName': 'Jeffrey J H', 'Initials': 'JJH', 'LastName': 'Cheung', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada. jeffreyjcheung@gmail.com.'}, {'ForeName': 'Kulamakan M', 'Initials': 'KM', 'LastName': 'Kulasegaram', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Woods', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Brydges', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}]",Journal of general internal medicine,['10.1007/s11606-019-04959-y']
1214,30914170,Developing Experimental Vignettes to Identify Gender Norms Associated With Transactional Sex for Adolescent Girls and Young Women in Central Uganda.,"PURPOSE


Transactional sex or informal sexual exchange relationships increase adolescent girls' and young women's (AGYW) HIV and pregnancy risk in sub-Saharan Africa. These relationships are grounded in the shared expectation that men should provide financial support to their partners. We built a vignette experiment to assess whether gender norms influenced by expectations of provision help to explain how transactional sex increases AGYW's sexual and reproductive health risks.
METHODS


We used mixed methods to develop a vignette experiment in Central Uganda with AGYW including 10 focus group discussions, 32 cognitive interviews, and a pilot survey experiment with 108 sexually active unmarried AGYW. Respondents were randomly assigned to one of the two manipulations for three vignettes. The vignettes examined whether the amount a man provided changed perceived social approval of men's authority in relationships, sexual decision-making power, or women having multiple partners.
RESULTS


We find that a higher level of male provision is associated with higher levels of perceived community approval for his sexual decision-making power (p < .001) and lower levels of perceived peer approval for AGYW's to seek a second partner (p < .05). We also find that higher levels of male provision are associated with respondent's own approval of male authority and sexual decision-making.
CONCLUSION


Our findings suggest that approval of men's sexual decision-making power increases when they provide more and that girls who seek a second partner find higher levels of social approval for this behavior when their primary partner provides less. Vignette experiments may be valuable for identifying social norms that put AGYW's sexual and reproductive health at risk.",2019,Vignette experiments may be valuable for identifying social norms that put AGYW's sexual and reproductive health at risk.,"['Central Uganda with AGYW including 10 focus group discussions, 32 cognitive interviews, and a pilot survey experiment with 108 sexually active unmarried AGYW', ""adolescent girls' and young women's (AGYW) HIV and pregnancy risk in sub-Saharan Africa"", 'Adolescent Girls and Young Women in Central Uganda']",[],[],"[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]",[],[],108.0,0.0369005,Vignette experiments may be valuable for identifying social norms that put AGYW's sexual and reproductive health at risk.,"[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Stoebenau', 'Affiliation': 'Department of Behavioral and Community Health, University of Maryland School of Public Health, College Park, Maryland; Department of Sociology, The Center of Health, Risk and Society, American University, Washington, DC. Electronic address: kstoeben@umd.edu.'}, {'ForeName': 'Nambusi', 'Initials': 'N', 'LastName': 'Kyegombe', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Bingenheimer', 'Affiliation': 'Department of Prevention and Community Health, George Washington University Milken School of Public Health, Washington, DC.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Ddumba-Nyanzi', 'Affiliation': 'Department of Social Work and Social Administration, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mulindwa', 'Affiliation': 'Independent Consultant, Masaka, Uganda.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.11.009']
1215,31228618,Effect of Sublingual Immunotherapy on Airway Inflammation and Airway Wall Thickness in Allergic Asthma.,"BACKGROUND


The efficacy of the standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) has been demonstrated for respiratory allergic disease. However, the effects of SLIT on inflammation and structural changes of the airways are still unknown.
OBJECTIVE


The aim of this study was to assess the effects of the 6 SQ-HDM SLIT on airway inflammation and airway geometry in allergic asthma and rhinitis.
METHODS


One hundred two asthmatic patients with rhinitis sensitized to HDM were randomized to receive either SLIT plus pharmacotherapy or standard pharmacotherapy alone, for 48 weeks. Fractional exhaled nitric oxide (FeNO), pulmonary function, quantitative computed tomography, and clinical symptoms were performed at baseline and end of the study.
RESULTS


Compared with pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area/body surface area (WA/BSA, P < .001), wall thickness (T/√BSA, P < .001), percentage wall area (WA/Ao, P < .01), increase in luminal area (Ai/BSA, P < .05), improvement of airflow limitation (P < .001), and clinical symptom scores (P < .05). The change in forced expiratory volume in 1 second (FEV 1 ) was correlated with both changes in FeNO and airway dimensions. Multiple regression analysis showed that the change in FeNO was independently associated with an increase in FEV 1  in the SLIT group (r 2  = 0.623, P = .037).
CONCLUSIONS


Adding 6 SQ-HDM SLIT to standard asthma therapy provides a significant improvement in symptoms and pulmonary function compared with pharmacotherapy. Improvement of airflow limitation with SLIT was associated with the decrease in eosinophilic airway inflammation.",2019,"Compared to pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area /body","['allergic asthma and rhinitis', 'One hundred two asthmatic patients with rhinitis sensitized to HDM', 'allergic asthma']","['6 SQ-HDM SLIT', 'SLIT', 'sublingual immunotherapy', 'standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT', 'SLIT plus pharmacotherapy or standard pharmacotherapy alone']","['clinical symptom scores', 'percentage wall area', 'airway wall area /body', 'FEV', 'luminal area', 'Fractional exhaled nitric oxide (FeNO), pulmonary function, quantitative computed tomography and clinical symptoms', 'improvement of airflow limitation', 'airway inflammation and airway wall thickness', 'FeNO', 'wall thickness (T/√BSA', 'symptoms and pulmonary function', 'eosinophilic airway inflammation']","[{'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3539110', 'cui_str': 'house dust mites'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",102.0,0.0200091,"Compared to pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area /body","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Clinical Allergy, Department of Internal Medicine, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan. Electronic address: hoshino@iuhw.ac.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.06.003']
1216,30924166,"Can furosemide prevent transfusion-associated circulatory overload? Results of a pilot, double-blind, randomized controlled trial.","BACKGROUND


Transfusion-associated circulatory overload (TACO) is a leading cause of transfusion-attributable morbidity. It is unclear whether diuretics are safe and effective in preventing this reaction.
MATERIALS AND METHODS


In a pilot controlled feasibility trial, inpatients 65 years or older ordered a single unit of red blood cells were randomized to pre-transfusion furosemide 20 mg or placebo intravenously. Primary outcome was the ability to enroll 80 patients within a 2-month time period. Secondary feasibility outcomes included proportion of RBC transfusions meeting eligibility criteria, proportion of eligible patients enrolled, and compliance to study protocol. Clinical outcomes included the incidence of TACO and associated complications.
RESULTS


Nine months of enrollment were required for 80 patients to complete the study, due primarily to fewer transfusions than expected meeting eligibility criteria and lower than anticipated consent rates. Protocol compliance was below target due to missing chart documentation of patient fluid balance, and transfusion infusion time. Blinding was maintained throughout the study and treatment arms were well-balanced. A single case of TACO occurred in each arm, for an overall incidence of 2.5%. No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
CONCLUSION


The study protocol was not feasible as designed, primarily due to challenges in patient enrollment. Modifications to trial design to improve feasibility in future studies have been identified.",2019,"No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
",['inpatients 65\u2009years or older ordered a single unit of red blood cells'],"['pre-transfusion furosemide 20\u2009mg or placebo', 'TACO', 'furosemide']","['incidence of TACO and associated complications', 'peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0986198', 'cui_str': 'Furosemide 20 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4553714', 'cui_str': 'Taco'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4553714', 'cui_str': 'Taco'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.361932,"No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pendergrast', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Armali', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cserti-Gazdewich', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute of Clinical and Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Lieberman', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagina', 'Initials': 'N', 'LastName': 'Parmar', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Scales', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Skeate', 'Affiliation': 'Canadian Blood Services, Toronto, Ontario, Canada.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}]",Transfusion,['10.1111/trf.15270']
1217,30922083,Characterization and predictive mechanisms of experimentally induced tension-type headache.,"OBJECTIVE


Studies have shown it is possible to elicit a tension-type headache episode in 15 to 30% of healthy individuals following a tooth-clenching or stress-inducing task. Despite this, no studies have attempted to understand why some healthy individuals develop a headache episode while others do not.
METHODS


The present randomized, single-blind, controlled study recruited 60 healthy participants who participated in a 30-minute tooth-clenching task and 10 participants who participated in a control task. Before the tasks, participants had their pericranial tenderness and pain modulation profiles (wind-up ratio and conditioned pain modulation) assessed. Two hours later, pericranial tenderness and pressure pain thresholds were assessed as well as any developing temporomandibular disorders. Pain diaries were kept for 24 hours to register any developing pain or headache.
RESULTS


Participants with a decrease in pericranial tenderness after the tooth-clenching task were less likely to develop headache when compared to participants without. Pain modulation profiles could not predict who developed headache and who did not. Finally, no difference was found between groups for developing temporomandibular disorders. No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
CONCLUSIONS


In conclusion, it was shown that increased pericranial tenderness was not required to trigger an episode of tension-type headache in healthy participants. Furthermore, pain modulation profiles could not predict who developed headache and who did not. Finally, activation of descending inhibitory pathways, as assessed by decreases in pericranial tenderness, was protective against the development of headache. These findings provide new insights into the pathophysiology of experimentally-induced tension-type headache.",2019,"No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
","['60 healthy participants who participated in a 30-minute tooth-clenching task and 10 participants who participated in a control task', 'healthy participants']",[],"['pericranial tenderness and pressure pain thresholds', 'pain or headache', 'Pain diaries', 'headache', 'pericranial tenderness', 'pericranial tenderness and pain modulation profiles', 'develop headache', 'temporomandibular disorders']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0424444', 'cui_str': 'Clenching teeth (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0451366', 'cui_str': 'Pain diary (assessment scale)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]",60.0,0.0644487,"No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
","[{'ForeName': 'Fernando Gustavo', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karina H', 'Initials': 'KH', 'LastName': 'Bendixen', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': '2 Scandinavian Center for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Flemming Winther', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': '4 Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419840779']
1218,24659838,Landmark Estimation of Survival and Treatment Effect in a Randomized Clinical Trial.,"In many studies with a survival outcome, it is often not feasible to fully observe the primary event of interest. This often leads to heavy censoring and thus, difficulty in efficiently estimating survival or comparing survival rates between two groups. In certain diseases, baseline covariates and the event time of non-fatal intermediate events may be associated with overall survival. In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups. If gains in efficiency can be achieved, it may then be possible to decrease the sample size of patients required for a study to achieve a particular power level or decrease the duration of the study. Most existing methods for incorporating intermediate events and covariates to predict survival focus on estimation of relative risk parameters and/or the joint distribution of events under semiparametric models. However, in practice, these model assumptions may not hold and hence may lead to biased estimates of the marginal survival. In this paper, we propose a semi-nonparametric two-stage procedure to estimate and compare  t -year survival rates by incorporating intermediate event information observed before some landmark time, which serves as a useful approach to overcome semi-competing risks issues. In a randomized clinical trial setting, we further improve efficiency through an additional calibration step. Simulation studies demonstrate substantial potential gains in efficiency in terms of estimation and power. We illustrate our proposed procedures using an AIDS Clinical Trial Protocol 175 dataset by estimating survival and examining the difference in survival between two treatment groups: zidovudine and zidovudine plus zalcitabine.",2014,"In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups.",[],['zidovudine and zidovudine plus zalcitabine'],"['survival rates', 'survival', 'overall survival']",[],"[{'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012132', 'cui_str': 'Zalcitabine'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.110883,"In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups.","[{'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Parast', 'Affiliation': 'RAND Corporation, Santa Monica, CA 90401.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Stanford University, Department of Health, Research and Policy, Stanford, CA 94305.'}, {'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Harvard University, Department of Biostatistics, Boston, MA 02115.'}]",Journal of the American Statistical Association,[]
1219,30845322,"Community Engagement Before Initiation of Typhoid Conjugate Vaccine Trial in Schools in Two Urban Townships in Blantyre, Malawi: Experience and Lessons.","BACKGROUND


To determine the efficacy of a new typhoid conjugate vaccine in an endemic setting in sub-Saharan Africa, the Typhoid Vaccine Acceleration Consortium is conducting a phase-3 randomized controlled trial in Blantyre, Malawi. This article describes community and stakeholder engagement activities before and during the trial, challenges, and lessons learned.
METHODS


In October 2017, Malawi-Liverpool Wellcome Trust (MLW) organized a wide range of community engagement activities, including meetings with Ministry of Health and Education officials at the district and facility level, local community leadership, and parent teacher association groups. We engaged media outlets to include local and international television, radio, and print media. Community members were informed directly through a study jingle played via loudspeaker from a van and by community-based activities.To review engagement activity effectiveness: The MLW team met to discuss progress and challenges; and a focus group discussion (FGD), consisting of trial staff, sought feedback from the community on each engagement modality.
RESULTS


The school-based vaccine campaign increased community participation exceeding recruitment targets to date (on average, >200 children/day).
CONCLUSIONS


The FGD concluded that the van and local activities improved awareness and turnout for the trial, but prior engagement with local government and community leadership is an essential mechanism to provide details of the study, answer questions, communicate the value of the study, and address safety concerns. Effective community engagement is essential in a large intervention trial. Multiple channels of communication are required to reach the community and deliver information needed for participation and provide opportunity for dialogue with the trial team.",2019,"The school-based vaccine campaign increased community participation exceeding recruitment targets to date (on average, >200 children/day).
",[],['new typhoid conjugate vaccine'],[],[],"[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]",[],,0.118338,"The school-based vaccine campaign increased community participation exceeding recruitment targets to date (on average, >200 children/day).
","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Meiring', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Sambakunsi', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elvis', 'Initials': 'E', 'LastName': 'Moyo', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Misiri', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Felistas', 'Initials': 'F', 'LastName': 'Mwakiseghile', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Pratiksha', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ndaferankhande', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Laurens', 'Affiliation': 'Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gooding', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Melita A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1110']
1220,30896743,Dietary Calcium Intake and Bone Loss Over 6 Years in Osteopenic Postmenopausal Women.,"CONTEXT


Calcium intakes are commonly lower than the recommended levels, and increasing calcium intake is often recommended for bone health.
OBJECTIVE


To determine the relationship between dietary calcium intake and rate of bone loss in older postmenopausal women.
PARTICIPANTS


Analysis of observational data collected from a randomized controlled trial. Participants were osteopenic (hip T-scores between -1.0 and -2.5) women, aged >65 years, not receiving therapy for osteoporosis nor taking calcium supplements. Women from the total cohort (n = 1994) contributed data to the analysis of calcium intake and bone mineral density (BMD) at baseline, and women from the placebo group (n = 698) contributed data to the analysis of calcium intake and change in BMD. BMD and bone mineral content (BMC) of the spine, total hip, femoral neck, and total body were measured three times over 6 years.
RESULTS


Mean calcium intake was 886 mg/day. Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status, and past hormone replacement use. There was no relationship between bone loss and quintile of calcium intake at any site, with or without adjustment for covariables. Total body bone balance (i.e., change in BMC) was unrelated to an individuals' calcium intake (P = 0.99).
CONCLUSIONS


Postmenopausal bone loss is unrelated to dietary calcium intake. This suggests that strategies to increase calcium intake are unlikely to impact the prevalence of and morbidity from postmenopausal osteoporosis.",2019,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","['women aged >65 years not receiving therapy for osteoporosis, nor taking calcium supplements', 'osteopenic postmenopausal women', 'older postmenopausal women', 'Participants were osteopenic (hip T-scores between -1.0 and -2.5']",['placebo'],"['bone loss', 'BMD and bone mineral content (BMC) of the spine, total hip, femoral neck and total body', 'Baseline BMDs', 'Dietary calcium intake and bone loss', 'calcium intake and bone mineral density (BMD', 'calcium intake and change in BMD', 'Total body bone balance', 'bone loss and quintile of calcium intake']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.119109,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Bristow', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00111']
1221,31708151,"Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.
METHODS


We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.
FINDINGS


Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
INTERPRETATION


The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia.
FUNDING


WHO, India.",2019,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","['958 women in the', 'pregnant women with moderate-to-severe anaemia in India', 'women with moderate-to-severe iron deficiency anaemia in pregnancy', '961 women in the', '737 women in the', 'Between Jan 31, 2014, and July 31, 2017, 2018', 'four government medical colleges in India', 'Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL', 'pregnant women with moderate-to-severe anaemia']","['intravenous iron sucrose versus standard oral iron therapy', 'intravenous iron sucrose', 'standard oral iron therapy', 'intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy', 'intravenous iron sucrose (intervention) versus standard oral iron (control) therapy']","['Safety', 'modified intention-to-treat population', 'serious maternal adverse events', 'potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia', 'Serious fetal and neonatal adverse events', 'safety and clinical effectiveness', 'Safety and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0269936', 'cui_str': 'Postpartum Sepsis'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",982.0,0.316237,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","[{'ForeName': 'Sutapa B', 'Initials': 'SB', 'LastName': 'Neogi', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India. Electronic address: sutapa.bneogi@iiphd.org.'}, {'ForeName': 'Niveditha', 'Initials': 'N', 'LastName': 'Devasenapathy', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Bhushan', 'Affiliation': 'National Health Systems Resource Centre, New Delhi, India.'}, {'ForeName': 'Duru', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Breach Candy Hospital, Mumbai, India; Indian College of Obstetricians and Gynaecologists, Federation of Obstetrics and Gynaecology Society of India, Mumbai, India.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Divakar', 'Affiliation': ""Divakar's Speciality Hospital, Bangalore, India.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Zodpey', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Smiti', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Achla', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Meenakshi B', 'Initials': 'MB', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Dongre', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Saluja', 'Affiliation': 'Department of Hematology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Sangwan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Radhika', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Bhaskaran', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Mrinalini', 'Initials': 'M', 'LastName': 'Kotru', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sikka', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Francis', 'Affiliation': 'WHO, New Delhi, India.'}, {'ForeName': 'Kasonde', 'Initials': 'K', 'LastName': 'Mwingak', 'Affiliation': 'WHO, Kigali, Rwanda.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Baswal', 'Affiliation': 'Ministry of Health and Family Welfare, Government of India, New Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30427-9']
1222,30922873,Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study.,"BACKGROUND


The aim of this study was to evaluate the long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis using 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial.
METHODS


In the double-blind phase of POISE, 217 patients with primary biliary cholangitis with inadequate response to or intolerance to ursodeoxycholic acid were randomised to receive placebo, obeticholic acid 5 to 10 mg, or obeticholic acid 10 mg once daily for 12 months. During the open-label extension phase, patients received variable, adjusted doses of obeticholic acid. Markers of cholestasis and liver injury, alkaline phosphatase (ALP), and total and direct bilirubin were evaluated, and safety was assessed for up to 48 months of treatment with obeticholic acid. All analyses in the open-label extension were done in the safety population, defined as any patient randomised in the double-blind phase who received at least one dose of obeticholic acid during the open-label extension. This trial is registered at ClinicalTrials.gov (NCT01473524) and with EudraCT (2011-004728-36).
FINDINGS


193 patients were treated during the open-label extension. In this 3-year interim analysis, ALP concentrations were significantly reduced compared with baseline at 12 months (mean change -105·2 U/L [SD 87·6]), 24 months (-101·0 U/L [98·5]), 36 months (-108·6 U/L [95·7]), and 48 months (-95·6 U/L [121·1]; p<0·0001 for all yearly time points). Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016). Stabilisation was also noted for direct bilirubin, with a significant change from baseline at 12 months (mean change -0·5 μmol/L [SD 3·0]; p=0·021). However, changes in total and direct bilirubin were not significant at other time points. Obeticholic acid was generally well tolerated, with pruritus (149 [77%] patients) and fatigue (63 [33%]) being the most common adverse events. No serious adverse events were considered related to obeticholic acid.
INTERPRETATION


Interim analyses suggest long-term efficacy and safety of obeticholic acid in patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid.
FUNDING


Intercept Pharmaceuticals.",2019,"Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016).","['patients with primary biliary cholangitis', 'patients with primary biliary cholangitis using 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial', 'patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid', '217 patients with primary biliary cholangitis with inadequate response to or intolerance to', '193 patients were treated during the open-label extension']","['EudraCT', 'obeticholic acid', 'Obeticholic acid', 'placebo, obeticholic acid 5 to 10 mg, or obeticholic acid', 'ursodeoxycholic acid']","['fatigue', 'Total bilirubin concentrations', 'Markers of cholestasis and liver injury, alkaline phosphatase (ALP), and total and direct bilirubin', 'ALP concentrations', 'direct bilirubin', 'total and direct bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}]",217.0,0.383306,"Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Nevens', 'Affiliation': 'University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Liver Institute of Hampton Roads, Newport News, VA, USA.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Radboudumc, Nijmegen, Netherlands.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Andreone', 'Affiliation': 'Center for Research and Study of Hepatitis, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Centre for Liver Research, NIHR Birmingham Liver Biomedical Research Unit, Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pencek', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'Elizabeth Smoot', 'Initials': 'ES', 'LastName': 'Malecha', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30094-9']
1223,30858689,Comparison of smartphone ophthalmoscopy vs conventional direct ophthalmoscopy as a teaching tool for medical students: the COSMOS study.,"Purpose


To investigate the utility of smartphone ophthalmology for medical students for learning fundoscopy compared with direct ophthalmoscopy.
Methods


After 1 hour of didactic instruction on ophthalmoscopy, second-year medical students in a small group setting were randomized to start training with the direct ophthalmoscope vs smartphone ophthalmoscope and crossed over to the other instrument through the session.
Main outcome measures


Ability to visualize the optic nerve and retinal blood vessels in an undilated pupil as well as a survey evaluating ease of use, confidence, and ability to visualize the optic nerve with the two instruments.
Results


One hundred and one medical students participated. Significantly more medical students were able to visualize the optic nerve with the smartphone ophthalmoscope vs the direct ophthalmoscope in an undilated pupil (82.3% vs 48.5%,  P <0.0001). Students reported a more positive experience with the smartphone ophthalmoscope, specifically regarding ease of use (median of 4 vs 3;  P <0.0001), their confidence in performing ophthalmoscopy (median of 4 vs 3;  P <0.0001), and their ability to visualize features of the optic nerve (median 4 vs 3;  P <0.0001). A significant number of participants preferred the smartphone ophthalmoscope over the traditional direct ophthalmoscope for learning how to identify the optic disc and for evaluating patients (78.2% and 77.2%, respectively;  P <0.0001).
Conclusion


Smartphone ophthalmoscopy may serve as a useful adjunctive tool to teach direct ophthalmoscopy as well as being an alternative for examining the fundus for noneye care physicians.",2019,"A significant number of participants preferred the smartphone ophthalmoscope over the traditional direct ophthalmoscope for learning how to identify the optic disc and for evaluating patients (78.2% and 77.2%, respectively;  P <0.0001).
","['medical students for learning fundoscopy compared with direct ophthalmoscopy', 'medical students', 'One hundred and one medical students participated']","['smartphone ophthalmoscopy vs conventional direct ophthalmoscopy', 'smartphone ophthalmology', 'start training with the direct ophthalmoscope vs smartphone ophthalmoscope and crossed over to the other instrument through the session', 'didactic instruction']","['Ability to visualize the optic nerve and retinal blood vessels in an undilated pupil as well as a survey evaluating ease of use, confidence, and ability to visualize the optic nerve with the two instruments', 'ability to visualize features of the optic nerve']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0029090', 'cui_str': 'Ophthalmoscopy'}, {'cui': 'C1444581', 'cui_str': 'Direct ophthalmoscopy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0029090', 'cui_str': 'Ophthalmoscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1444581', 'cui_str': 'Direct ophthalmoscopy (procedure)'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0182047', 'cui_str': 'Direct ophthalmoscope'}, {'cui': 'C0182046', 'cui_str': 'Funduscopes'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0029130', 'cui_str': 'Cranial Nerve II'}, {'cui': 'C0035330', 'cui_str': 'Retinal Blood Vessels'}, {'cui': 'C2711346', 'cui_str': 'Undilated pupil (finding)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",101.0,0.0246048,"A significant number of participants preferred the smartphone ophthalmoscope over the traditional direct ophthalmoscope for learning how to identify the optic disc and for evaluating patients (78.2% and 77.2%, respectively;  P <0.0001).
","[{'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Shiley Eye Institute, University of California, San Diego, CA, USA, dlchao@ucsd.edu.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Chao', 'Affiliation': 'Department of Ophthalmology, Shiley Eye Institute, University of California, San Diego, CA, USA, dlchao@ucsd.edu.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S190922']
1224,30848415,The Influence of Treatment Engagement on Positive Outcomes in the Context of a School-Based Intervention for Students with Externalizing Behavior Problems.,"We examined the stability of and cross-influences between externalizing behaviors and intervention engagement among children participating in a randomized clinical trial of an intervention for disruptive behavioral youth. Analyses also accounted for the influence of caregiver depression, family relationship quality, and sociodemographic factors (race, income) on the relationship between behaviors and intervention engagement. Analyses were based on 118 children participating in the Coping Power intervention. Composite variables were created to represent externalizing behaviors and intervention engagement constructs. Associations between these composite variables were examined over 24 treatment sessions. Findings indicated a regressive relationship among externalizing behaviors, i.e., baseline externalizing behaviors were positively associated with immediate follow-up behaviors. There were also dynamic relationships observed among engagement constructs. Notably, engagement with in-session activities during sessions 1-8 was positively associated with out-of-session activity engagement during the same treatment time period. Engagement with out-of-session activities during sessions 1-8 was positively associated with in-session activity engagement during sessions 9-16, indicating a complete mediation between early and middle in-session engagement through the mechanism of early out-of-session engagement. A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up. Finally, an interaction of race by income on immediate follow-up externalizing behaviors was observed, such that Black children's externalizing behaviors remain static regardless of income level while White children's behaviors decreased with higher income. Our findings support the contention that focusing on intervention engagement may be especially important in prevention interventions.",2019,A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up.,"['children participating in a randomized clinical trial of an intervention for disruptive behavioral youth', '118 children participating in the Coping Power intervention', 'Students with Externalizing Behavior Problems']",[],"['caregiver depression, family relationship quality, and sociodemographic factors (race, income', 'baseline externalizing behaviors', 'externalizing behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",118.0,0.0222043,A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Lindsey', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA. Michael.Lindsey@nyu.edu.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Romanelli', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Mesha L', 'Initials': 'ML', 'LastName': 'Ellis', 'Affiliation': 'Ellis Evaluation & Consulting Services, Atlanta, GA, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Barker', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Boxmeyer', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lochman', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, AL, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00525-6']
1225,31338732,Nicotinic treatment of post-chemotherapy subjective cognitive impairment: a pilot study.,"PURPOSE


Persistent chemotherapy-related cognitive impairment (pCRCI) is commonly reported following cancer treatment and negatively affects quality of life; however, there is currently no pharmacological treatment indicated for pCRCI. This pilot study obtained preliminary data regarding the use of transdermal nicotine patches as a therapeutic strategy for women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI.
METHODS


Participants were randomized to either placebo (n = 11) or transdermal nicotine (n = 11) for 6 weeks, followed by 2 weeks of treatment withdrawal for a total of 8 weeks. Participants were assessed using both subjective and objective measures of cognitive functioning at five visits before, during, and after treatment.
RESULTS


Over the course of the study, women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm. Additionally, objective cognitive performance measures improved in both groups; however, there was no significant difference in improvement between groups.
CONCLUSIONS


Due to a large placebo response, we were unable to determine if a drug effect was present. However, we did observe substantial improvement in self-reported cognitive symptoms, likely resulting from factors related to participation in the trial rather than specific drug treatment effects.
TRIAL REGISTRATION


The study was registered with clinicaltrials.gov (trial registration: NCT02312943).
IMPLICATIONS FOR CANCER SURVIVORS


These results suggest that women with pCRCI can exhibit improvement in subjective cognition, with attention paid to symptoms and close follow-up over a short period of time.",2019,", women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm.","['Participants', 'FOR CANCER SURVIVORS', 'women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI', 'post-chemotherapy subjective cognitive impairment']","['Nicotinic', 'placebo', 'transdermal nicotine', 'transdermal nicotine patches']","['severity of self-reported cognitive complaints', 'subjective cognition', 'objective cognitive performance measures']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439577', 'cui_str': 'Post-chemotherapy (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.228972,", women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Vega', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA. Jennifer.n.vega.1@vumc.org.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Albert', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Warren D', 'Initials': 'WD', 'LastName': 'Taylor', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Newhouse', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00786-6']
1226,31347010,Psychological intervention (ConquerFear) for treating fear of cancer recurrence: mediators and moderators of treatment efficacy.,"PURPOSE


ConquerFear is an efficacious intervention for fear of cancer recurrence (FCR) that demonstrated greater improvements than an attention control (relaxation training) in a randomized controlled trial. This study aimed to determine mediators and moderators of the relative treatment efficacy of ConquerFear versus relaxation.
METHODS


One hundred and fifty-two cancer survivors completed 5 therapy sessions and outcome measures before and after intervention and at 6 months' follow-up. We examined theoretically relevant variables as potential mediators and moderators of treatment outcome. We hypothesized that metacognitions and intrusions would moderate and mediate the relationship between treatment group and FCR level at follow-up.
RESULTS


Only total FCR score at baseline moderated treatment outcome. Participants with higher levels of FCR benefited more from ConquerFear relative to relaxation on the primary outcome. Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
CONCLUSIONS


These results show that ConquerFear is relatively more effective than relaxation for those with overall higher levels of FCR. The mediation analyses confirmed that the most likely mechanism of treatment efficacy was the reduction in unhelpful metacognitions and intrusive thoughts during treatment, consistent with the theoretical framework underpinning ConquerFear.
IMPLICATIONS FOR CANCER SURVIVORS


ConquerFear is a brief, effective treatment for FCR in cancer survivors with early-stage disease. The treatment works by reducing intrusive thoughts about cancer and changing beliefs about worry and is particularly helpful for people with moderate to severe FCR.",2019,"Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
","['One hundred and fifty-two cancer survivors', 'cancer survivors with early-stage disease', 'people with moderate to severe FCR']","['attention control (relaxation training', 'ConquerFear versus relaxation', 'Psychological intervention (ConquerFear']",['total FCR score'],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0577072,"Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia. louise.sharpe@sydney.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mental Health Centre, Faculty of Medicine, University of Queensland, Saint Lucia, Australia.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Fardell', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital and School of Women's and Children's Health, Faculty of Medicine, University of New South Wales, Saint Lucia, Australia.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thewes', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Smith', 'Affiliation': 'Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gilchrist', 'Affiliation': 'Crown Princess Mary Cancer Centre, Breast Cancer Institute, Westmead Hospital, Westmead, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beith', 'Affiliation': 'Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Camperdown, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Girgis', 'Affiliation': 'Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tesson', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grunewald', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Butow', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00788-4']
1227,31707503,Effects of a home-exercise programme in childhood survivors of acute lymphoblastic leukaemia on physical fitness and physical functioning: results of a randomised clinical trial.,"PURPOSE


The aim of this study was to evaluate the effects of a home-exercise programme on physical fitness indicators and physical functioning after completion of chemotherapy in children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL).
METHODS


Twenty-four survivors of ALL were assigned to usual care (control group, n = 12, 11.0 ± 3.7 years) or to a home-exercise programme (intervention group, n = 12, 11.8 ± 4.3 years). Peak oxygen uptake (VO 2 peak ml/kg/min), minute ventilation (VE L/min), output of carbon dioxide (VCO 2  L/min), respiratory exchange ratio (RER), peak heart rate (beats/min), maximal load (W), VO 2  at anaerobic threshold (VO 2  at AT, ml/kg/min), pulse oxygen (PO 2  ml/beat), heart rate at anaerobic threshold (beats/min), handgrip test (pounds), flexibility (cm), Timed Up & Go test TUG (s), and Timed Up and Down Stairs test (TUDS s) were measured at baseline and over 16 weeks of intervention.
RESULTS


Adjusted mixed linear models revealed a significant group-time interaction + 6.7 (95% CI = 0.6-12.8 ml/kg/min; η 2  partial = 0.046, P = 0.035) for VO 2 peak. Similarly, changes in mean values were observed after the home-exercise programme compared with baseline for VE (L/min) - 8.8 (3.0) (P = 0.035), VCO 2  - 0.2 (0.08), (P = 0.041), maximal load (W) - 35.5 (12.8) (P = 0.024), TUDS (s) 0.8 (2.6) (P = 0.010), and TUG (s) 0.6 (0.1) (P = 0.001); however, the group-time interaction was not significant.
CONCLUSION


The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test). This is an interesting and important study that surely adds to the current body of knowledge/literature on the safety of exercise interventions, especially in children with haematological cancer.",2020,"The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test).","['children with haematological cancer', 'Twenty-four survivors of ALL were assigned to usual care (control group, n = 12, 11.0 ± 3.7 years) or to a', 'children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL', 'childhood survivors of acute lymphoblastic leukaemia on physical fitness and physical functioning']","['home-exercise programme (intervention', 'chemotherapy', 'home-exercise programme']","['physical fitness indicators and physical functioning', 'Peak oxygen uptake (VO 2 peak ml/kg/min), minute ventilation (VE L/min), output of carbon dioxide (VCO 2  L/min), respiratory exchange ratio (RER), peak heart rate (beats/min), maximal load (W), VO 2  at anaerobic threshold (VO 2  at AT, ml/kg/min), pulse oxygen (PO 2  ml/beat), heart rate at anaerobic threshold (beats/min), handgrip test (pounds), flexibility (cm), Timed Up & Go test TUG (s), and Timed Up and Down Stairs test (TUDS s', 'mean values', 'measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0456718', 'cui_str': 'mL/beat'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",24.0,0.112242,"The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test).","[{'ForeName': 'Jahn Dubery', 'Initials': 'JD', 'LastName': 'Manchola-González', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Caritat', 'Initials': 'C', 'LastName': 'Bagur-Calafat', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Girabent-Farrés', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Josep Ricard', 'Initials': 'JR', 'LastName': 'Serra-Grima', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Roser Álvarez', 'Initials': 'RÁ', 'LastName': 'Pérez', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Manuel Vicente', 'Initials': 'MV', 'LastName': 'Garnacho-Castaño', 'Affiliation': 'Research group in physical activity, performance and health (GRI-AFIRS), School of Health Sciences, TecnoCampus-Pompeu Fabra University, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Badell', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed-Universidad Pública de Navarra (UPNA)-Complejo Hospitalario de Navarra (CHN), Instituto de Investigación Sanitaria de Navarra (IdiSNA), 31008, Pamplona, Navarra, Spain. robin640@hotmail.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05131-2']
1228,31707553,Cardioprotective effect of hyperkalemic cardioplegia in an aquaporin 7-deficient murine heart.,"BACKGROUND


Hyperkalemic cardioplegia using St. Thomas' Hospital solution No. 2 (STH2) is commonly used to protect the myocardium during surgery. Mice deficient in the myocyte channel aquaporin 7 (AQP7) show significantly reduced glycerol and ATP contents and develop obesity; however, the influence of AQP7 on cardioplegia effectiveness remains unclear.
METHODS


After determining the influence of ischemic duration on cardiac function, isolated hearts of male wild-type (WT) and AQP7-knockout (KO) mice (> 13 weeks old) were aerobically Langendorff-perfused with bicarbonate buffer, and randomly allocated to the control group (25 min of global ischemia) and STH2 group (5 min of STH2 infusion before 20 min of global ischemia, followed by 60 min of reperfusion).
RESULTS


Final recovery of left ventricular developed pressure (LVDP) of WT and AQP7-KO hearts in the control group was 24.5 ± 12.4% and 20.6 ± 8.4%, respectively, which were significantly lower than those of the STH2 group (96.4 ± 12.7% and 92.9 ± 27.6%). Troponin T levels of WT and AQP-KO hearts significantly decreased in the STH2 groups (142.9 ± 27.2 and 219.9 ± 197.3) compared to those of the control (1725.0 ± 768.6 and 1710 ± 819.9).
CONCLUSIONS


AQP7 was not involved in the protective efficacy of STH2 in this mouse model, suggesting its clinical utility even in complications of metabolic disease.",2020,"Mice deficient in the myocyte channel aquaporin 7 (AQP7) show significantly reduced glycerol and ATP contents and develop obesity; however, the influence of AQP7 on cardioplegia effectiveness remains unclear.
",['aquaporin 7-deficient murine heart'],"['hyperkalemic cardioplegia', 'Langendorff-perfused with bicarbonate buffer, and randomly allocated to the control group (25\xa0min of global ischemia) and STH2 group (5\xa0min of STH2 infusion before 20\xa0min of global ischemia, followed by 60\xa0min of reperfusion']","['Final recovery of left ventricular developed pressure (LVDP) of WT and AQP7-KO hearts', 'cardiac function, isolated hearts of male wild-type (WT) and AQP7-knockout (KO) mice', 'glycerol and ATP contents and develop obesity', 'Troponin T levels of WT and AQP-KO hearts']","[{'cui': 'C0756762', 'cui_str': 'Aquaporin-7 (substance)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}]","[{'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0206745', 'cui_str': 'Mice, Knock-out'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0246833,"Mice deficient in the myocyte channel aquaporin 7 (AQP7) show significantly reduced glycerol and ATP contents and develop obesity; however, the influence of AQP7 on cardioplegia effectiveness remains unclear.
","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiovascular Surgery, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. m-fujii@nms.ac.jp.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Department of Cardiovascular Surgery, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Bessho', 'Affiliation': 'Department of Cardiovascular Surgery, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-019-01243-y']
1229,30926276,"A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery.","OBJECTIVE


New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated.
METHODS


Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity.
RESULTS


The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively).
CONCLUSIONS


FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries.",2019,The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001).,"['Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited', 'patients undergoing open vascular surgeries']","['fibrin sealant (FS', 'Fibrin Sealant Grifols', 'FS Grifols or manual compression (MC']","['pyrexia', 'safety and efficacy', 'cumulative proportion', 'percentage of patients experiencing treatment-emergent AEs', 'recurrent being procedural pain', 'Cumulative proportion and time to hemostasis', 'adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity', 'proportion of the primary part patients achieving hemostasis', 'median time to hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042381', 'cui_str': 'Vascular Surgical Procedures'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0340654', 'cui_str': 'Arterial bleed'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0162492', 'cui_str': 'Viral Markers'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0815489,The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001).,"[{'ForeName': 'Dragoslav', 'Initials': 'D', 'LastName': 'Nenezić', 'Affiliation': 'Institute for Cardiovascular Diseases ""Dedinje"", Clinic for Vascular Surgery, Belgrade, Serbia. Electronic address: neneza55@gmail.com.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Ayguasanosa', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Menyhei', 'Affiliation': 'Department of Vascular Surgery, Pecs University Clinical Center, Pecs, Hungary.'}, {'ForeName': 'Holjencsik', 'Initials': 'H', 'LastName': 'Tamás', 'Affiliation': 'Department of Vascular Surgery, Csolnoky Ferenc County Hospital, Veszprem, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Borsod Teaching County Hospital Miskolc, Borsod, Hungary.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Muluk', 'Affiliation': 'Division of Vascular Surgery, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Kecia', 'Initials': 'K', 'LastName': 'Courtney', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2018.12.051']
1230,30915778,"Effects of three treatment modalities (diet, myoinositol or myoinositol associated with D-chiro-inositol) on clinical and body composition outcomes in women with polycystic ovary syndrome.","OBJECTIVE


To evaluate, in overweight/obese PCOS women, which of three distinct treatment modalities achieved the greatest clinical benefits in terms of clinical and body composition outcomes.
PATIENTS AND METHODS


Forty-three polycystic ovary syndrome (PCOS) overweight/obese patients were randomly treated for 6 months with: only diet (Group 1, n = 21); diet and myo-inositol (MI) 4 g + folic acid 400 µg daily (group 2, n = 10); diet in association with MI 1.1 g + D-chiroinositol (DCI) 27.6 mg + folic acid 400 µg daily (group 3, n = 13). Menstrual cycle, Ferriman-Gallwey score, body mass index (BMI), waist circumference, hip circumference, waist-hip ratio (WHR), and body composition by bioimpedentiometry were measured at baseline, 3 and 6 months.
RESULTS


Body weight, BMI, waist and hip circumferences decreased significantly in all groups. There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
CONCLUSIONS


MI+DCI in association with diet seems to accelerate the weight loss and the fat mass reduction with a slight increase of percent lean mass, and this treatment contributes significantly in restoring the regularity of the menstrual cycle.",2019,"There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
","['Forty-three polycystic ovary syndrome (PCOS) overweight/obese patients', 'women with polycystic ovary syndrome', 'overweight/obese PCOS women']","['g + D-chiroinositol (DCI) 27.6 mg + folic acid', 'three treatment modalities (diet, myoinositol or myoinositol associated with D-chiro-inositol', 'diet and myo-inositol (MI) 4 g + folic acid 400 µg daily']","['restoration of menstrual regularity', 'weight loss', 'Body weight, BMI, waist and hip circumferences', 'Menstrual cycle, Ferriman-Gallwey score, body mass index (BMI), waist circumference, hip circumference, waist-hip ratio (WHR), and body composition by bioimpedentiometry']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",43.0,0.0421363,"There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Donne', 'Affiliation': 'Department of Human Pathology in Adulthood and Childhood ""G. Barresi"", University of Messina, Messina, Italy. mledonne@unime.it.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Metro', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benvenga', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201903_17278']
1231,31707815,"Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions.","BACKGROUND


Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.
METHODS


This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.
RESULTS


In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.
CONCLUSIONS


This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.",2019,"Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years).",['migraine'],"['erenumab, a novel calcitonin gene-related peptide receptor antagonist', 'placebo', 'erenumab']","['constipation', 'adverse events', 'exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies', 'Exposure-adjusted adverse event rates', 'muscle spasm', 'rates of injection site reactions, constipation, and muscle spasm']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4704728', 'cui_str': 'CGRP Receptor Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",,0.665144,"Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years).","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolezil', 'Affiliation': 'Dado Medical sro, Prague Headache Center, Prague, Czech Republic.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Yanchen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888222']
1232,30701365,Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial.,"OBJECTIVE


To present surgical and oncological outcomes using a prospective and randomized trial (LapOpHuva, NCT02727179) comparing minimally invasive liver resection (LLR) versus open liver resection (OLR) in patients with colorectal liver metastases (CRLM).
METHODS


Between February 2005 and March 2016, 204 selected patients with CRLM were randomized and 193 were included: LLR (n = 96) and OLR (n = 97). The primary endpoint was to compare postoperative morbidity. Other secondary endpoints were oncological outcomes, use of the Pringle maneuver, surgical time, blood losses, transfusions, hospital stay, mortality and OS, and disease-free survival (DFS) at 3, 5, and 7 years.
RESULTS


LLR presented with lower global morbidity (11.5% vs. 23.7%, p = 0.025) but with similar severe complications. Long-term survival outcomes were similar in both groups. The cumulative 1-, 3-, 5-, 7-year OS for LLR and OLR were 92.5%, 71.5%, 49.3%, 35.6% versus 93.6%, 69.7%, 47.4%, 35.5%, respectively (log-rank = 0.047, p = 0.82). DFS for LLR and OLR was 72.7%, 33.5%, 22.7%, and 20.8% versus 61.6%, 27.2%, 23.9%, and 17.9%, respectively (log-rank = 1.427, p = 0.23). LLR involved more use of the Pringle maneuver (15.5% vs. 30.2%, p = 0.025) and a shorter hospital stay (4 vs. 6 days, p < 0.001). There were no differences regarding surgical time, blood losses, transfusion, and mortality.
CONCLUSIONS


In selected patients with CRLM, LLR presents similar oncological outcomes with the advantages of the short-term results associated with LLR.",2019,"RESULTS


LLR presented with lower global morbidity (11.5% vs. 23.7%, p = 0.025) but with similar severe complications.","['Between February 2005 and March 2016, 204 selected patients with CRLM were randomized and 193 were included: LLR (n\u2009=\u200996) and OLR (n\u2009=\u200997', 'patients with colorectal liver metastases (CRLM', 'colorectal liver metastases (LapOpHuva']","['Open versus minimally invasive liver surgery', 'minimally invasive liver resection (LLR) versus open liver resection (OLR']","['cumulative 1-, 3-, 5-, 7-year OS for LLR and OLR', 'postoperative morbidity', 'oncological outcomes, use of the Pringle maneuver, surgical time, blood losses, transfusions, hospital stay, mortality and OS, and disease-free survival (DFS) at 3, 5, and 7\xa0years', 'global morbidity', 'surgical time, blood losses, transfusion, and mortality', 'DFS for LLR and OLR', 'Long-term survival outcomes', 'shorter hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",204.0,0.0823272,"RESULTS


LLR presented with lower global morbidity (11.5% vs. 23.7%, p = 0.025) but with similar severe complications.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Robles-Campos', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain. rirocam@um.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Lopez-Lopez', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Brusadin', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Lopez-Conesa', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}, {'ForeName': 'Pedro José', 'Initials': 'PJ', 'LastName': 'Gil-Vazquez', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Navarro-Barrios', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Parrilla', 'Affiliation': 'Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.'}]",Surgical endoscopy,['10.1007/s00464-019-06679-0']
1233,30925575,Augmented Subscleral Trabeculectomy With Beta Radiation and Mitomycin C in Egyptian Glaucoma Patients.,"PURPOSE


Subscleral trabeculectomy is the most common surgical treatment for glaucoma. However, wound healing and scar formation may result in bleb fibrosis, leading to bleb failure. The healing response of the wound is reported to be the single most important risk factor in determining the final intraocular pressure (IOP) after glaucoma filtration surgery. Thus, we aimed to evaluate the effect of preoperative beta irradiation and intraoperative mitomycin C (MMC) treatment as combined adjuncts to subscleral trabeculectomy in the management of glaucoma in Egyptian patients.
PATIENTS AND METHODS


This prospective, interventional, comparative masked clinical study was performed between October 2016 and January 2018. This study included 50 subjects, 25 of whom underwent trabeculectomy augmented by MMC intraoperatively and beta radiation preoperatively at the bleb area (patient group #1). The remaining 25 subjects underwent trabeculectomy with MMC alone (control group #2). Beta radiation was administered 5 to 7 days before the surgery as a single dose (1000 cGy) using a strontium-90 probe. MMC (0.2 mg/mL) was administered for 2 minutes.
RESULTS


There was a statistically significant difference in postoperative IOP between the groups from the second week. Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant.
CONCLUSIONS


Subscleral trabeculectomy augmented by beta radiation and MMC gives greater control over IOP. Therefore, we recommend using beta radiation before trabeculectomy in patients who may have a high risk of developing conjunctival fibrosis.",2019,"Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant.
","['50 subjects, 25 of whom underwent trabeculectomy augmented by MMC intraoperatively and beta radiation preoperatively at the bleb area (patient group #1', 'Egyptian patients', 'patients who may have a high risk of developing conjunctival fibrosis', 'Egyptian Glaucoma Patients', 'October 2016 and January 2018']","['preoperative beta irradiation and intraoperative mitomycin C (MMC', 'Subscleral Trabeculectomy With Beta Radiation and Mitomycin C', 'subscleral trabeculectomy', 'Beta radiation', 'MMC', 'trabeculectomy with MMC', 'Subscleral trabeculectomy']","['healing response', 'intraoperative hyphema', 'Intraoperative hyphema', 'wound healing and scar formation', 'postoperative IOP']","[{'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2607955', 'cui_str': 'Beta Rays'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C2607955', 'cui_str': 'Beta Rays'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.0399427,"Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant.
","[{'ForeName': 'Hesham M', 'Initials': 'HM', 'LastName': 'El Mazar', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}, {'ForeName': 'Sameh S', 'Initials': 'SS', 'LastName': 'Mandour', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Mostafa', 'Affiliation': 'Ophthalmology in Mataria Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Elmorsy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001255']
1234,30922990,"Tiotropium Is Efficacious in 6- to 17-Year-Olds with Asthma, Independent of T2 Phenotype.","BACKGROUND


Tiotropium add-on therapy has demonstrated efficacy and safety in 6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids (ICSs), with or without additional controllers. Pediatric patients often have a significant allergic component to their asthma.
OBJECTIVE


To explore whether responses to tiotropium add-on were influenced by patients' type 2 status, assessed by serum IgE levels and blood eosinophil counts.
METHODS


Data from 2 phase III trials in symptomatic moderate asthma (CanoTinA-asthma; RubaTinA-asthma) and 2 phase III trials in symptomatic severe asthma (VivaTinA-asthma; PensieTinA-asthma) were pooled by severity. Patients were treated with tiotropium 5 μg, tiotropium 2.5 μg, or placebo (2 puffs once daily via Respimat inhaler), as add-on to ICSs, with or without additional controllers. Modeling of efficacy outcomes was performed over the whole range of baseline IgE levels and blood eosinophil counts, and the treatment effect of the tiotropium doses was presented graphically.
RESULTS


Improvements with tiotropium in peak FEV 1  within 3 hours postdose, trough FEV 1 , forced expiratory flow at 25% to 75% of the pulmonary volume, and FEV 1 /forced vital capacity responses were generally consistent across the range of baseline IgE levels and blood eosinophil counts. Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
CONCLUSIONS


This exploratory analysis suggests that improvements with tiotropium as add-on to ICSs, with or without additional controllers, in 6- to 17-year-olds with symptomatic asthma do not vary according to systemic markers of T2 inflammation, namely, total IgE and blood eosinophil counts.",2019,"Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
","['Data from 2 phase III trials in symptomatic moderate asthma (CanoTinA-asthma; RubaTinA-asthma) and 2 phase III trials in symptomatic severe asthma (VivaTinA-asthma; PensieTinA-asthma', 'Pediatric patients often have a significant allergic component to their asthma', '6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids (ICSs), with or without additional controllers']","['Tiotropium', 'tiotropium', 'tiotropium 2.5 μg, or placebo']","['peak FEV 1  within 3 hours postdose, trough FEV 1 , forced expiratory flow', 'blood eosinophil counts', 'Asthma Control Questionnaire responder rates', 'baseline IgE levels and blood eosinophil counts', 'FEV 1 /forced vital capacity responses', 'efficacy and safety', 'serum IgE levels and blood eosinophil counts', 'total IgE and blood eosinophil counts']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.317722,"Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""The Breathing Institute, Children's Hospital of Colorado, Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'Department of Pediatric Pneumology and Allergology, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Goldstein', 'Affiliation': 'Island Medical Research, Rockville Centre, New York, NY.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Mansfield', 'Affiliation': 'Western Sky Medical Research, El Paso, Texas.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Zaremba-Pechmann', 'Affiliation': 'Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'TA Respiratory Diseases, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Eckard', 'Initials': 'E', 'LastName': 'Hamelmann', 'Affiliation': ""Children's Center Bethel, Evangelisches Klinikum Bethel, Bielefeld, Germany; Allergy Center of the Ruhr University, Bochum, Germany.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.03.019']
1235,30655277,Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness  versus  tiotropium alone in COPD.,"The 3-min constant speed shuttle test (CSST) was used to examine the effect of tiotropium/olodaterol compared with tiotropium at reducing activity-related breathlessness in patients with chronic obstructive pulmonary disease (COPD).This was a randomised, double-blind, two-period crossover study including COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8. Patients received 6 weeks of tiotropium/olodaterol 5/5 µg and tiotropium 5 µg in a randomised order with a 3-week washout period. The speed for the 3-min CSST was determined for each patient such that an intensity of breathing discomfort ≥4 (""somewhat severe"") on the modified Borg scale was reached at the end of a completed 3-min CSST.After 6 weeks, there was a decrease in the intensity of breathlessness (Borg dyspnoea score) at the end of the 3-min CSST from baseline with both tiotropium (mean -0.968, 95% CI -1.238- -0.698; n=100) and tiotropium/olodaterol (mean -1.325, 95% CI -1.594- -1.056; n=101). The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.",2019,"The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.","['COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8', 'patients with chronic obstructive pulmonary disease (COPD).This', 'dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation', 'COPD']","['tiotropium', 'tiotropium/olodaterol', 'tiotropium/olodaterol 5/5\u2005µg and tiotropium', '3-min constant speed shuttle test (CSST']","['decrease in breathlessness', 'activity-related breathlessness', 'intensity of breathlessness (Borg dyspnoea score']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test (procedure)'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.181198,"The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, QC, Canada.'}, {'ForeName': 'Joseph-Leon', 'Initials': 'JL', 'LastName': 'Aumann', 'Affiliation': 'Longartsenpraktijk, Hasselt, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Kirsten', 'Affiliation': 'Pulmonary Research Institute, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Nadreau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, QC, Canada.'}, {'ForeName': 'Hemani', 'Initials': 'H', 'LastName': 'Macesic', 'Affiliation': 'Boehringer Ingelheim Canada, Burlington, ON, Canada.'}, {'ForeName': 'Xidong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'Boehringer Ingelheim Canada, Burlington, ON, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Queen's University and Kingston General Hospital, Kingston, ON, Canada.""}]",The European respiratory journal,['10.1183/13993003.02049-2018']
1236,31708059,Projected Cost-Effectiveness for 2 Gene-Drug Pairs Using a Multigene Panel for Patients Undergoing Percutaneous Coronary Intervention.,"BACKGROUND


For patients undergoing percutaneous coronary intervention, gene-drug associations exist relevant to first-line treatment options-antiplatelet agent, clopidogrel, and pain medication, tramadol. Knowledge of genotype information may allow for avoidance of adverse drug events during critical clinical windows.
OBJECTIVE


This evaluation estimated cost-effectiveness associated with a multi-gene panel pre-emptively testing two genes providing CYP2C19 genotype-guided strategy for antiplatelet therapy, with CYP2D6 genotype-guided pain management, compared to single gene test for CYP2C19 with random assignment for pain treatment, and to no testing (empiric clopidogrel with random assignment for pain treatment).
METHODS


Decision analysis modeling was used to project costs from a payer perspective and patient quality-adjusted life years (QALYs) from the three strategies. The model captured composite risks of major adverse cardiovascular events and pain therapy-related adverse drug events and associated utility estimates. We conducted sensitivity analyses to assess influential input parameters.
RESULTS


Over 15 months, multi-gene testing was least costly and yielded more QALYs compared to both single gene and no testing; total incremental costs were $1646 lower with incremental gains of 0.04 QALYs for multi-gene compared with single gene and $11 368 lower with 0.17 QALY gains compared to no test. Base case analyses revealed multi gene was dominant compared to both single gene and no test, as it demonstrated cost savings with increased QALYs.
CONCLUSIONS


For these patients, a multi-gene-guided strategy yields a favorable incremental cost-effectiveness ratio compared to the other two treatment strategies. Pre-emptively ascertaining additional gene-drug pair information can inform clinical and economic decision-making at the point of care.",2019,"Over 15 months, multi-gene testing was least costly and yielded more QALYs compared to both single gene and no testing; total incremental costs were $1646 lower with incremental gains of 0.04 QALYs for multi-gene compared with single gene and $11 368 lower with 0.17 QALY gains compared to no test.","['patients undergoing', 'Patients Undergoing Percutaneous Coronary Intervention']","['multi-gene panel pre-emptively testing two genes providing CYP2C19 genotype-guided strategy for antiplatelet therapy, with CYP2D6 genotype-guided pain management', 'tramadol', 'percutaneous coronary intervention']","['cost savings', 'total incremental costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1646.0,0.0401619,"Over 15 months, multi-gene testing was least costly and yielded more QALYs compared to both single gene and no testing; total incremental costs were $1646 lower with incremental gains of 0.04 QALYs for multi-gene compared with single gene and $11 368 lower with 0.17 QALY gains compared to no test.","[{'ForeName': 'M Ragan', 'Initials': 'MR', 'LastName': 'Hart', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA, USA; Institute for Public Health Genetics, University of Washington, Seattle, WA, USA. Electronic address: hartmr@stanford.edu.'}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Garrison', 'Affiliation': 'Department of Pharmacy, The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Doyle', 'Affiliation': 'Institute for Public Health Genetics, University of Washington, Seattle, WA, USA; Washington State Department of Health, Kent, WA, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'University of Washington Department of Medicine (Medical Genetics), Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department of Pharmacy, The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA; Premera Blue Cross, Mountlake Terrace, WA, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Devine', 'Affiliation': 'Institute for Public Health Genetics, University of Washington, Seattle, WA, USA; Department of Pharmacy, The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.05.015']
1237,30889034,Correlation of Electronic (Web-Based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction: A Randomized Controlled Trial.,"OBJECTIVE


We hypothesized that instruments of pelvic floor dysfunction would yield similar responses on web-based and smartphone administration compared with paper.
METHODS


Subjects presenting with pelvic floor disorders were prospectively enrolled at 5 sites and invited to complete 4 validated pelvic floor disorder questionnaires (Pelvic Floor Distress Inventory 20, Pelvic Floor Impact Questionnaire 7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12, Bristol Stool Scale) on both paper and electronic formats, 2 weeks apart, with the order of administration being randomized. Participants completed the questionnaires electronically on the internet via REDCap or using the PelvicTrack App on a smartphone or tablet.
RESULTS


Two hundred thirty-four subjects were enrolled, and 132 subjects (56%) completed both sets of questionnaires with no intervening treatment. This group was 58 (±15) years old with body mass index 28 (±6) kg/m and parity 2 (1, 3) and was 77% white, 6% African American, 7% Asian, and 10% other. Presenting complaints were classified as 58% urinary, 37% prolapse, and 5% defecatory. There was no difference in overall demographic information between those who completed the second round of questionnaires and those who did not. There was no difference in age between those who chose to complete the questionnaires via REDcap and those who chose to complete the questionnaires via smartphone. Correlation coefficients between questionnaire administration range from 0.5 to 0.8. There was no significant difference in the responses for each total scale and individual scale between the first or second administration.
CONCLUSIONS


We demonstrated moderate to strong reliability between scales of pelvic floor dysfunction administered electronically compared with paper version. Our results strongly suggest that it is feasible and reliable to administer pelvic floor questionnaires in an electronic format on REDCap and on smartphones.",2020,"There was no significant difference in the responses for each total scale and individual scale between the first or second administration.
","['Two hundred thirty-four subjects were enrolled, and 132 subjects (56%) completed both sets of questionnaires with no intervening treatment', 'Subjects presenting with pelvic floor disorders were prospectively enrolled at 5 sites and invited to complete 4 validated', 'This group was 58 (±15) years old with body mass index 28 (±6) kg/m and parity 2 (1, 3) and was 77% white, 6% African American, 7% Asian, and 10% other']","['internet via REDCap or using the PelvicTrack App on a smartphone or tablet', 'Electronic (Web-Based and Smartphone']","['total scale and individual scale', 'Pelvic Floor Dysfunction', 'pelvic floor disorder questionnaires (Pelvic Floor Distress Inventory 20, Pelvic Floor Impact Questionnaire 7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12, Bristol Stool Scale', 'overall demographic information']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0233071', 'cui_str': 'Para 2 (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction (disorder)'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",234.0,0.0304391,"There was no significant difference in the responses for each total scale and individual scale between the first or second administration.
","[{'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Grimes', 'Affiliation': 'From the Department of Obstetrics and Gynecology, New York Medical College, Valhalla, NY.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Antosh', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Houston Methodist Hospital, Houston, TX.'}, {'ForeName': 'Sallie', 'Initials': 'S', 'LastName': 'Oliphant', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Ladin', 'Initials': 'L', 'LastName': 'Yurteri-Kaplan', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Shunaha', 'Initials': 'S', 'LastName': 'Kim-Fine', 'Affiliation': 'Section of Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Melamud', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Heisler', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Doreen E', 'Initials': 'DE', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Columbia University Medical Center, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000713']
1238,30880285,CRP-guided antibiotic treatment in acute exacerbations of COPD in hospital admissions.,"The role of antibiotics in acute exacerbations of chronic obstructive pulmonary disease (COPD) is controversial and a biomarker identifying patients who benefit from antibiotics is mandatory. We performed a randomised, controlled trial in patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy, in order to show a reduction in antibiotic prescription.Patients hospitalised with acute exacerbations of COPD were randomised to receive antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50 mg·L -1 ).In total, 101 patients were randomised to the CRP group and 119 to the GOLD group. Fewer patients in the CRP group were treated with antibiotics compared to the GOLD group (31.7%  versus  46.2%, p=0.028; adjusted odds ratio (OR) 0.178, 95% CI 0.077-0.411, p=0.029). The 30-day treatment failure rate was nearly equal (44.5% in the CRP group  versus  45.5% in the GOLD-group, p=0.881; adjusted OR 1.146, 95% CI 0.649-1.187, p=0.630), as was the time to next exacerbation (32 days in the CRP group  versus  28 days in the GOLD group, p=0.713; adjusted hazard ratio 0.878, 95% CI 0.649-1.187, p=0.398). Length of stay was similar in both groups (7 days in the CRP group  versus  6 days in the GOLD group, p=0.206). On day-30, no difference in symptom score, quality of life or serious adverse events was detected.Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment. In the present study, no differences in adverse events between both groups were found. Further research is needed for the generalisability of these findings.",2019,Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment.,"['acute exacerbations of COPD in hospital admissions', 'Patients hospitalised with acute exacerbations of COPD', '101 patients were randomised to the CRP group and 119 to the GOLD group', 'patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy', 'acute exacerbations of chronic obstructive pulmonary disease (COPD']","['CRP-guided antibiotic treatment', 'CRP', 'antibiotics', 'antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50']","['time to next exacerbation', 'symptom score, quality of life or serious adverse events', 'adverse events', '30-day treatment failure rate', 'Length of stay']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",101.0,0.102958,Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment.,"[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Prins', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Duijkers', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van der Valk', 'Affiliation': 'Dept of Pulmonary Diseases, Medic Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Dept of Clinical Chemistry, Haematology and Immunology, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Dept of Pulmonary Diseases, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tjip S', 'Initials': 'TS', 'LastName': 'van der Werf', 'Affiliation': 'University of Groningen, Dept of Pulmonary Diseases and Tuberculosis, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}]",The European respiratory journal,['10.1183/13993003.02014-2018']
1239,30880286,Randomised controlled trial of polysomnographic titration of noninvasive ventilation.,"Noninvasive ventilation (NIV) settings determined during wakefulness may produce patient-ventilator asynchrony (PVA) during sleep, causing sleep disruption and limiting tolerance. This study investigated whether NIV titrated with polysomnography (PSG) is associated with less PVA and sleep disruption than therapy titrated during daytime alone.Treatment-naive individuals referred for NIV were randomised to control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration) groups. Primary outcomes were PVA and arousal indices on PSG at 10 weeks. Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised. Most (88.3%) had a neuromuscular disorder and respiratory muscle weakness but minor derangements in daytime arterial blood gases. PVA events were less frequent in those undergoing polysomnographic titration (median (interquartile range (IQR)): PSG 25.7 (12-68) events·h -1   versus  control 41.0 (28-182) events·h -1 ; p=0.046), but arousals were not significantly different (median (IQR): PSG 11.4 (9-19) arousals·h -1   versus  control 14.6 (11-19) arousals·h -1 ; p=0.258). Overall adherence was not different except in those with poor early adherence (<4 h·day -1 ) who increased their use after polysomnographic titration (mean difference: PSG 95 (95% CI 29-161) min·day -1   versus  control -23 (95% CI -86-39) min·day -1 ; p=0.01). Arterial carbon dioxide tension, somnolence and sleep quality improved in both groups. There were no differences in nocturnal gas exchange or overall measures of HRQoL.NIV titrated with PSG is associated with less PVA but not less sleep disruption when compared with therapy titrated during daytime alone.",2019,"Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised.",['Treatment-naive individuals referred for NIV'],"['NIV titrated with polysomnography (PSG', 'control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration', 'polysomnographic titration of noninvasive\xa0ventilation', 'Noninvasive ventilation (NIV']","['neuromuscular disorder and respiratory muscle weakness', 'adherence, gas exchange, symptoms and health-related quality of life', 'nocturnal gas exchange or overall measures', 'Overall adherence', 'Arterial carbon dioxide tension, somnolence and sleep quality', 'PVA and arousal indices on PSG', 'PVA events', 'daytime arterial blood gases']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0027868', 'cui_str': 'Neuromuscular Diseases'}, {'cui': 'C1836141', 'cui_str': 'Respiratory muscle weakness'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1269842', 'cui_str': 'Finding of arterial partial pressure of carbon dioxide'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}]",60.0,0.22368,"Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised.","[{'ForeName': 'Liam M', 'Initials': 'LM', 'LastName': 'Hannan', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rautela', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berlowitz', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sheers', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chao', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Fergal J', 'Initials': 'FJ', 'LastName': ""O'Donoghue"", 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}]",The European respiratory journal,['10.1183/13993003.02118-2018']
1240,30919407,The oral Janus kinase/spleen tyrosine kinase inhibitor ASN002 demonstrates efficacy and improves associated systemic inflammation in patients with moderate-to-severe atopic dermatitis: results from a randomized double-blind placebo-controlled study.,"BACKGROUND


ASN002 is an oral dual inhibitor of Janus kinase and spleen tyrosine kinase, which are involved in the pathogenesis of atopic dermatitis (AD) through their regulatory role on T helper (Th)1, Th2 and Th17/Th22 pathways.
OBJECTIVES


The objectives of this study were to evaluate the efficacy, safety, pharmacokinetics and effects on systemic biomarkers of ASN002 in patients with moderate-to-severe AD. Methods A total of 36 patients with moderate-to-severe AD were randomized (3 : 1) to ASN002 or placebo in the phase Ib study. Three dosage cohorts were studied over a 28-day period (20 mg, 40 mg and 80 mg once daily).
RESULTS


ASN002 was superior to placebo for the proportion of patients achieving Eczema Area and Severity Index (EASI) 50 (20 mg 20%, P = 0·93; 40 mg 100%, P = 0·003; 80 mg 83%, P = 0·03; placebo 22%), EASI 75 (20 mg 0%, P = 0·27; 40 mg 71%, P = 0·06; 80 mg 33%, P = 0·65; placebo 22%) and in change from baseline in pruritus (20 mg -1·3 ± 2·1, P = 0·81; 40 mg -3·1 ± 2·7, P = 0·27; 80 mg -4·7 ± 2·1, P = 0·01; placebo -1·6 ± 1·8). Adverse events were generally mild and similar across all groups. ASN002 showed dose-dependent plasma exposure with low interpatient variability, significantly downregulated several serum biomarkers involved in Th1, Th2 and Th17/Th22 immunity, and decreased the atherosclerosis-associated biomarker E selectin/SELE.
CONCLUSIONS


In patients with moderate-to-severe AD, ASN002 showed strong efficacy with rapid onset of action and associated improvements in systemic inflammation.",2019,"RESULTS


ASN002 was superior to placebo for the proportion of patients achieving Eczema Area and Severity Index (EASI) 50 (20 mg 20%, P = 0·93; 40 mg 100%, P = 0·003; 80 mg 83%, P = 0·03; placebo 22%), EASI 75 (20 mg 0%,","['patients with moderate-to-severe atopic dermatitis', ' 0·65', '36 patients with moderate-to-severe AD', 'patients with moderate-to-severe AD']","['EASI', 'ASN002 or placebo', 'placebo']","['Eczema Area and Severity Index', 'systemic inflammation', 'Adverse events', 'efficacy, safety, pharmacokinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",36.0,0.408702,"RESULTS


ASN002 was superior to placebo for the proportion of patients achieving Eczema Area and Severity Index (EASI) 50 (20 mg 20%, P = 0·93; 40 mg 100%, P = 0·003; 80 mg 83%, P = 0·03; placebo 22%), EASI 75 (20 mg 0%,","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research Inc., 1851 Sherbrooke Street East, Suite 502, Montreal, H2K 4L5, Quebec, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research Inc., 1851 Sherbrooke Street East, Suite 502, Montreal, H2K 4L5, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'Forward Clinical Trials, Inc., 4915 Ehrlich Road, Tampa, 33624, FL, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Therapeutics Clinical Research, 9025 Balboa Avenue, Suite 105, San Diego, 92123, CA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Progressive Clinical Research, P.A., LLC, 1973 North West Loop 410, Suite 106, San Antonio, 78213, TX, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fowler', 'Affiliation': 'Dermatology Specialists Research, 3810 Springhurst Boulevard, Suite 130, Louisville, 40241, KY, U.S.A.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Center for Clinical Studies, University of Texas Health Science Center, 451 North Texas Avenue, Houston, 77598, TX, U.S.A.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., 6160 Kempsville Circle, Suite 200A, Norfolk, 23502, VA, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sofen', 'Affiliation': 'Dermatology Research Associates, 8930 South Sepulveda Boulevard, Los Angeles, 90045, CA, U.S.A.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dhawan', 'Affiliation': 'Center for Dermatology Clinical Research Inc., 2557 Mowry Avenue, Suite 21 and 25, Fremont, 94538, CA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zook', 'Affiliation': 'Olympian Clinical Research, 1201 South Myrtle Avenue, Clearwater, 33756, FL, U.S.A.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Zammit', 'Affiliation': 'Asana BioSciences, LLC, 997 Lenox Drive, Suite 220, Princeton Pike Corporate Center, Lawrenceville, 08648, NJ, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Usansky', 'Affiliation': 'Asana BioSciences, LLC, 997 Lenox Drive, Suite 220, Princeton Pike Corporate Center, Lawrenceville, 08648, NJ, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Denis', 'Affiliation': 'Asana BioSciences, LLC, 997 Lenox Drive, Suite 220, Princeton Pike Corporate Center, Lawrenceville, 08648, NJ, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': 'Asana BioSciences, LLC, 997 Lenox Drive, Suite 220, Princeton Pike Corporate Center, Lawrenceville, 08648, NJ, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, Icahn Building 13-76, New York, 10029, NY, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, Icahn Building 13-76, New York, 10029, NY, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, Icahn Building 13-76, New York, 10029, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17932']
1241,31708152,"Effect of co-trimoxazole prophylaxis on morbidity and mortality of HIV-exposed, HIV-uninfected infants in South Africa: a randomised controlled, non-inferiority trial.","BACKGROUND


WHO guidelines recommend co-trimoxazole prophylaxis for HIV-exposed, HIV-uninfected infants. These guidelines date back to an era in which HIV testing of infants was impossible and mothers had poor access to antiretroviral treatment. To determine whether this guideline requires revision in the current era of effective prevention of mother-to-child transmission and early infant diagnosis programmes, we aimed to investigate whether receiving no co-trimoxazole prophylaxis is inferior to receiving co-trimoxazole prophylaxis in the resulting incidence of grade 3 or 4 common childhood illnesses or mortality in breastfed HIV-exposed, HIV-uninfected infants.
METHODS


We investigated our aim in a randomised controlled, non-inferiority trial. We enrolled the HIV-negative infants of mothers living with HIV who were actively involved in transmission prevention programmes in two clinics in Durban, South Africa. Infants were included in the study if they were breastfeeding at the screening and enrolment visits, and their mother was planning to breastfeed for at least 6 months; were a singleton birth and had a birthweight of 2 kg or more; had no clinically observed genetic disorders; and had no serious illnesses and had not received antibiotics or traditional medications (such as herbal remedies). Infants were randomly assigned (1:1) to receive co-trimoxazole or no co-trimoxazole. In the co-trimoxazole group, infants received the drug until all exposure to HIV had ceased (ie, 6 weeks after last exposure to breastmilk) and the infant was confirmed to be uninfected with HIV. The drug was administered by mothers in once-daily regimens of 20 mg trimethoprim and 100 mg sulfamethoxazole orally (age <6 months or bodyweight <5 kg), or 40 mg trimethoprim and 200 mg sulfamethoxazole orally (age >6 months or bodyweight >5 kg). Clinical and laboratory staff always remained masked to group assignment, but mothers and study counsellors were not. Infants and their mothers attended study visits at ages 6 weeks (for enrolment and randomisation), 10 weeks, 14 weeks, and then monthly from 4 to 12 months. Our primary outcome was the incidence of grade 3 or 4 common childhood illnesses (pneumonia or diarrhoea) or mortality in breastfed HIV-exposed, HIV-uninfected infants by age 12 months. A non-inferiority bound of 5% was used. The study is registered with the Pan African Clinical Trials Registry, number PACTR201311000621110, and the South African National Clinical Trials Registry, number DOH-27-0614-4728.
FINDINGS


We screened 1570 mother-child pairs for study enrolment, from whom (78%) eligible infants were enrolled into the study between Oct 16, 2013, and May 23, 2018. Of the infants enrolled, 611 (50%) were randomly assigned to the co-trimoxazole group and 609 (50%) were randomly assigned to the no co-trimoxazole group. One (<1%) infant in the no co-trimoxazole group was excluded from the analysis of the final outcomes for having received traditional medicine (which only became apparent after randomisation); therefore, 611 (50%) infants in the co-trimoxazole group and 608 (50%) infants in the no co-trimoxazole group were included in the final intention-to-treat analysis. 136 (22%) infants in the co-trimoxazole group and 139 (23%) infants in the no co-trimoxazole group did not complete the 12-month study visit, predominantly because of loss to follow-up (93 [15%] infants in the co-trimoxazole group; 90 [15%] infants in the no co-trimoxazole group). The cumulative probability of the composite primary outcome was 0·114 (95% CI 0·076 to 0·147; 49 events) in the co-trimoxazole group versus 0·0795 (0·044 to 0·115; 39 events) in the no co-trimoxazole group. The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319 (-0·075 to 0·011), meaning that the risk was around 3 percentage points lower in the no co-trimoxazole group on the additive scale.
INTERPRETATION


We can conclude that no co-trimoxazole is not inferior to daily co-trimoxazole among breastfed HIV-exposed, HIV-uninfected infants whose mothers are accessing a prevention of mother-to-child transmission programme in an area unaffected by malaria. We therefore believe that WHO should revise the co-trimoxazole guidelines for HIV-exposed, HIV-uninfected infants in areas unaffected by malaria.
FUNDING


HIV Prevention Research Unit of the South African Medical Research Council and the Family Larsson-Rosenquist Foundation.",2019,The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319,"['Infants were included in the study if they were breastfeeding at the screening and enrolment visits, and their mother was planning to breastfeed for at least 6 months; were a singleton birth and had a birthweight of 2 kg or more; had no clinically observed genetic disorders; and had no serious illnesses and had not received antibiotics or traditional medications (such as herbal remedies', 'HIV-negative infants of mothers living with HIV who were actively involved in transmission prevention programmes in two clinics in Durban, South Africa', '1570 mother-child pairs for study enrolment, from whom (78%) eligible infants were enrolled into the study between Oct 16, 2013, and May 23, 2018', 'for HIV-exposed, HIV-uninfected infants', 'HIV-exposed, HIV-uninfected infants in South Africa', 'group and 609 (50', 'infants enrolled, 611 (50']","['trimoxazole', 'trimethoprim', 'co-trimoxazole prophylaxis', 'sulfamethoxazole', 'co-trimoxazole or no co-trimoxazole', 'trimoxazole prophylaxis', 'no co-trimoxazole']","['incidence of grade 3 or 4 common childhood illnesses (pneumonia or diarrhoea) or mortality', 'cumulative probability of the composite primary outcome', 'morbidity and mortality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1570.0,0.0844087,The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319,"[{'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coutsoudis', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa. Electronic address: coutsoud@ukzn.ac.za.'}, {'ForeName': 'Eshia', 'Initials': 'E', 'LastName': 'Moodley-Govender', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mulol', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Spooner', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Photini', 'Initials': 'P', 'LastName': 'Kiepiela', 'Affiliation': 'Medical Research Council of South Africa/Wits Health Consortium, Durban, South Africa.'}, {'ForeName': 'Shabashini', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Medical Research Council of South Africa/Wits Health Consortium, Durban, South Africa.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zako', 'Affiliation': 'eThekwini Municipality Health Unit, Durban, South Africa.'}, {'ForeName': 'Nhan T', 'Initials': 'NT', 'LastName': 'Ho', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa; Aurum Institute, Johannesburg, South Africa.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30422-X']
1242,30756142,"The Efficacy of Different Volumes on Ultrasound-Guided Type-I Pectoral Nerve Block for Postoperative Analgesia After Subpectoral Breast Augmentation: A Prospective, Randomized, Controlled Study.","BACKGROUND


PECS type-1 block, a US-guided superficial interfacial block, provides effective analgesia after breast surgery. Aesthetic breast augmentation is one of the most common surgical procedures in plastic surgery. Subpectoral prostheses cause severe pain. The aim of this study was to investigate the effect of different volumes of the solution on the efficacy of PECS type-I block for postoperative analgesia after breast augmentation surgery.
METHODS


Ninety ASA status I-II female patients aged between 18 and 65 years who scheduled breast augmentation surgery under general anesthesia were included in this study. The patients were randomly divided into three groups of 30 patients each (Group 20 = 20 ml of anaesthetic solution, Group 30 = 30 ml anaesthetic solution, and Group K = Control group). Postoperative assessment was performed using the VAS score. The VAS scores were recorded postoperatively at 1, 2, 4, 8, 16 and 24 h.
RESULTS


Fentanyl consumption was statistically significantly lower in Group 20 and Group 30 compared to the Control group (p < 0.05). There was no statistically significant difference in fentanyl consumption between Group 20 and Group 30. The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (p < 0.05). There was no statistical difference in terms of VAS scores between Group 20 and Group 30. The use of rescue analgesia was statistically lower in Groups 20 and 30.
CONCLUSIONS


PECS type-1 block using 20 ml of 0.25% bupivacaine can provide effective analgesia after breast augmentation surgery.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (,"['Subpectoral prostheses cause severe pain', 'Ninety ASA status I-II female patients aged between 18 and 65\xa0years who scheduled breast augmentation surgery under general anesthesia were included in this study']","['IV', 'PECS type-I block', 'bupivacaine', 'anaesthetic solution, Group 30\u2009=\u200930\xa0ml anaesthetic solution, and Group K\u2009=\u2009Control group', 'Ultrasound-Guided Type-I Pectoral Nerve Block for Postoperative Analgesia']","['rescue analgesia', 'VAS score', 'fentanyl consumption', 'VAS scores', 'Fentanyl consumption', 'right and left VAS scores']","[{'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441845', 'cui_str': 'Group K (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",90.0,0.0430778,The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (,"[{'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey. bciftci@medipol.edu.tr.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Erzurum Regional Training and Research Hospital, 25070, Yakutiye, Erzurum, Turkey.'}, {'ForeName': 'Muhammet Ahmet', 'Initials': 'MA', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01322-8']
1243,30877051,Predicting Patterns of Treatment Response and Outcome for Adolescents Who Are Suicidal and Depressed.,"OBJECTIVE


Although several treatments have been shown to be effective in treatment of youth suicidal thoughts and behaviors (STBs), there is a pressing need to account for the substantial variation in adolescents' response to and outcomes from these treatments.
METHOD


Secondary analyses of data from a 16-week randomized trial of Attachment-Based Family Therapy (ABFT) and Family-Enhanced NonDirective Supportive Therapy (FE-NST) identified distinct classes of adolescents' treatment response. Established risk factors for STBs, along with treatment condition and sociodemographic variables, were then tested as predictors of class membership.
RESULTS


Three patterns of adolescents' treatment response and outcome were identified: a) nonresponders (15.8%), b) good responders (57.5%), and c) partial responders (26.7%). After controlling for initial symptom severity, nonresponders were more likely to have higher levels of nonsuicidal self-injury and pessimism and were more likely to meet diagnostic criteria for major depressive disorder (MDD) than good or partial responders. Partial responders were more likely than good responders to meet criteria for MDD and to have higher perceived burdensomeness.
CONCLUSION


Although most adolescents showed significant symptom reductions with both treatments, adolescents with higher pretreatment levels of pessimism, MDD, nonsuicidal self-injury, and perceived burdensomeness were less likely to show an optimal pattern of treatment benefit. The findings point to heterogeneity in treatment response that may require adapting treatments for adolescents with these pretreatment profiles.
CLINICAL TRIAL REGISTRATION INFORMATION


Attachment-Based Family Therapy for Suicidal Adolescents; http://clinicaltrials.gov; NCT01537419.",2019,"After controlling for initial symptom severity, nonresponders were more likely to have higher levels of nonsuicidal self-injury and pessimism and were more likely to meet diagnostic criteria for major depressive disorder (MDD) than good or partial responders.",['Adolescents'],['Attachment-Based Family Therapy (ABFT) and Family-Enhanced NonDirective Supportive Therapy (FE-NST'],"['nonsuicidal self-injury and pessimism', 'pessimism, MDD, nonsuicidal self-injury, and perceived burdensomeness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0424134', 'cui_str': 'Negative Thinking'}]",,0.0369664,"After controlling for initial symptom severity, nonresponders were more likely to have higher levels of nonsuicidal self-injury and pessimism and were more likely to meet diagnostic criteria for major depressive disorder (MDD) than good or partial responders.","[{'ForeName': 'Caroline H', 'Initials': 'CH', 'LastName': 'Abbott', 'Affiliation': 'University of Delaware, Newark. Electronic address: cabbott@psych.udel.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zisk', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bounoua', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Diamond', 'Affiliation': 'Drexel University, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kobak', 'Affiliation': 'University of Delaware, Newark.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.12.013']
1244,30257983,Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial.,"OBJECTIVE


To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting.
DESIGN


Pragmatic, two arm, parallel group, open label, individually randomised controlled trial.
SETTING


10 primary care practices in Oxfordshire, UK.
PARTICIPANTS


278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months.
INTERVENTIONS


The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction.
MAIN OUTCOME MEASURES


The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded.
RESULTS


Participants in the TDR group lost more weight (-10.7 kg) than those in the usual care group (-3.1 kg): adjusted mean difference -7.2 kg (95% confidence interval -9.4 to -4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity.
CONCLUSIONS


Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials No ISRCTN75092026.",2018,45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more.,"['10 primary care practices in Oxfordshire, UK', 'Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET', '278 adults who were obese and seeking support to lose weight: 138 were assigned to the']","['total diet replacement (TDR) programme', 'TDR programme and 140 to usual care']","['Adverse events', 'weight loss', 'biomarkers of cardiovascular and metabolic risk', 'weight losses', 'adverse events of moderate or greater severity', 'weight change', 'weight']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454871', 'cui_str': 'Oxfordshire (geographic location)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",278.0,0.11681,45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more.,"[{'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK nerys.astbury@phc.ox.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Corfield', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.k3760']
1245,30879077,Testing threat-to-efficacy ratios in health communications about cardiovascular disease among an older population.,"To test threat-to-efficacy ratios within health communications about cardiovascular disease (CVD) for older individuals. Participants were randomly assigned to one of six messages: (i) 'standard' message with 1/1 threat-to-efficacy ratio, (ii) 'low efficacy' message with 1/0 threat-to-efficacy ratio, (iii) 'low threat' message with 0/1 threat-to-efficacy ratio, (iv) 'high efficacy' message with 1/2 threat-to-efficacy ratio; (v) 'high threat' message with 2/1 threat-to-efficacy ratio and (vi) 'overload' message with 2/2 threat-to-efficacy ratio. Participants had to be of 60 years of age or older (N = 242, Male = 92, Age: M = 68.29, SD = 6.71). Advanced univariate analyses and multiple regression modelling were conducted to examine associations between the message groups, and danger- and fear-control processes, as well as the impact of threat and efficacy appraisals on the relationship between the message groups and behavioural intentions. No differences were found between the message groups for danger-control processes. Those who received the 'overload' message did report higher levels of fear, nervousness and anxiety in comparison to the 'standard' message group. For physical activity, it was found that efficacy impacted the relationship between the message groups and behavioural intentions, as participants' levels of efficacy increased and if these individuals received high levels of efficacy information, their behavioural intentions for physical activity increased. Results from this study were dissimilar to those of previous research. However, they highlighted the impact of efficacy and negative emotional reactions when communicating to older individuals about CVD and the associated health behaviours.",2020,"Those who received the 'overload' message did report higher levels of fear, nervousness and anxiety in comparison to the 'standard' message group.","['Participants had to be of 60 years of age or older (N = 242, Male = 92, Age', 'older population', 'older individuals']","[""standard' message with 1/1 threat-to-efficacy ratio, (ii) 'low efficacy' message with 1/0 threat-to-efficacy ratio, (iii) 'low threat' message with 0/1 threat-to-efficacy ratio, (iv) 'high efficacy' message with 1/2 threat-to-efficacy ratio; (v) 'high threat' message with 2/1 threat-to-efficacy ratio and (vi) 'overload' message""]","['efficacy and negative emotional reactions', 'fear, nervousness and anxiety']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0580272', 'cui_str': '1/2'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",242.0,0.0268965,"Those who received the 'overload' message did report higher levels of fear, nervousness and anxiety in comparison to the 'standard' message group.","[{'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Moylett', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hevey', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin, Ireland.'}]",Health promotion international,['10.1093/heapro/daz019']
1246,30878103,"Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial.","BACKGROUND


Pulsed-wave ultrasound increases the exposure of an intracranial thrombus to alteplase (recombinant tissue plasminogen activator), potentially facilitating early reperfusion. We aimed to ascertain if a novel operator-independent transcranial ultrasound device delivering low-power high-frequency ultrasound could improve functional outcome in patients treated with alteplase after acute ischaemic stroke.
METHODS


We did a multicentre, double-blind, phase 3, randomised controlled trial (CLOTBUST-ER) at 76 medical centres in 14 countries. We included patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of symptom onset in North America and within 4·5 h of symptom onset in all other countries. Participants were randomly allocated (1:1) via an interactive web response system to either active ultrasound (2 MHz pulsed-wave ultrasound for 120 min [sonothrombolysis]; intervention group) or sham ultrasound (control group). Ultrasound was delivered using an operator-independent device, which had to be activated within 30 min of the alteplase bolus. Participants, investigators, and those assessing outcomes were unaware of group assignments. The primary outcome was improvement in the modified Rankin Scale score at 90 days in patients enrolled within 3 h of symptom onset, assessed in the intention-to-treat population as a common odds ratio (cOR) using ordinal logistic regression shift analysis. This trial is registered with ClinicalTrials.gov, number NCT01098981. The trial was stopped early by the funder after the second interim analysis because of futility.
FINDINGS


Between August, 2013, and April, 2015, 335 patients were randomly allocated to the intervention group and 341 patients to the control group. Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74). 51 (16%) of 317 patients in the intervention group and 44 (13%) of 329 patients in the control group died (unadjusted OR 1·24, 95% CI 0·80-1·92; p=0·37) and 83 (26%) and 79 (24%), respectively, had serious adverse events (1·12, 0·79-1·60; p=0·53).
INTERPRETATION


Sonothrombolysis delivered by an operator-independent device to patients treated with alteplase after acute ischaemic stroke was feasible and most likely safe, but no clinical benefit was seen at 90 days. Sonothrombolysis could be further investigated either in randomised trials undertaken in stroke centres that are dependent on patient transfer for endovascular reperfusion therapies or in countries where these treatments cannot yet be offered as the standard of care.
FUNDING


Cerevast Therapeutics.",2019,"Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74).","['patients treated with alteplase after acute ischaemic stroke', 'patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of symptom onset in North America and within 4·5 h of symptom onset in all other countries', 'acute ischaemic stroke', '76 medical centres in 14 countries', 'Between August, 2013, and April, 2015', '335 patients were randomly allocated to the intervention group and 341 patients to the control group']","['transcranial ultrasound device delivering low-power high-frequency ultrasound', 'sonothrombolysis', 'interactive web response system to either active ultrasound (2 MHz pulsed-wave ultrasound for 120 min [sonothrombolysis]; intervention group) or sham ultrasound (control group']","['cOR', 'modified Rankin Scale score', 'functional outcome', 'serious adverse events', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",335.0,0.513388,"Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74).","[{'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: avalexandrov@att.net.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Köhrmann', 'Affiliation': 'Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany; Department of Neurology, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Soinne', 'Affiliation': 'Department of Neurology, Helsinki University Hospital and Clinical Neurosciences, Neurology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsivgoulis', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA; Second Department of Neurology, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; International Clinical Research Center and Department of Neurology, St Anne\'s University Hospital in Brno, Brno, Czech Republic.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Barreto', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore and Division of Neurology, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Department of Neurology, St Anne's University Hospital in Brno, Brno, Czech Republic; Medical Faculty, Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Brandt', 'Affiliation': 'Cerevast Therapeutics, Redmond, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Alleman', 'Affiliation': 'Cerevast Therapeutics, Redmond, WA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Grotta', 'Affiliation': 'Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Saqqur', 'Affiliation': 'Department of Medicine (Neurology), University of Alberta, Edmonton, AB, Canada; Neuroscience Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Mavridis', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece; Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Psaltopoulou', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Vosko', 'Affiliation': 'Department of Neurology, Kepler University Clinic, General Hospital Linz (AKH), Linz, Austria.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Pitchaiah', 'Initials': 'P', 'LastName': 'Mandava', 'Affiliation': 'Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX, USA; Michael E DeBakey VA Medical Center Stroke Program and Center for Translational Research on Inflammatory Diseases, Houston, TX, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Kent', 'Affiliation': 'Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX, USA; Michael E DeBakey VA Medical Center Stroke Program and Center for Translational Research on Inflammatory Diseases, Houston, TX, USA.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA; Australian Catholic University, Sydney, NSW, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Schellinger', 'Affiliation': 'Departments of Neurology and Neurogeriatry, John Wesling Medical Center Minden, Ruhr University Bochum, Minden, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30026-2']
1247,30833170,"Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.","BACKGROUND


Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes. Few clinical trials have reported on the concomitant use of GLP-1 receptor agonists with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We aimed to investigate the efficacy and safety of semaglutide when added to SGLT-2 inhibitor therapy in patients with inadequately controlled type 2 diabetes.
METHODS


The SUSTAIN 9 double-blind, parallel-group trial was done at 61 centres in six countries (Austria, Canada, Japan, Norway, Russia, and the USA). Adults with type 2 diabetes and HbA 1c  7·0-10·0% (53-86 mmol/mol), despite at least 90 days of treatment with an SGLT-2 inhibitor, were randomly assigned (1:1) to receive subcutaneous semaglutide 1·0 mg or volume-matched placebo once weekly for 30 weeks, after a dose-escalation schedule of 4 weeks of 0·25 mg semaglutide or placebo and 4 weeks of 0·5 mg semaglutide or placebo. Existing antidiabetic medications, including SGLT-2 inhibitor treatment, were continued for the duration of the trial. Rescue medication, defined as intensification of background antidiabetic treatment or the initiation of new glucose-lowering medications, could be given to patients meeting specific criteria at the discretion of the investigator. The primary outcome was change in HbA 1c  from baseline at week 30, assessed in the full analysis set (all patients randomly allocated to treatment) using on-treatment data collected before rescue medication was started. The confirmatory secondary outcome was change in bodyweight from baseline to week 30. Safety was also assessed in the safety analysis set (all patients who received at least one dose of treatment). The trial was registered with ClinicalTrials.gov (NCT03086330).
FINDINGS


Between March 15, and Dec 4, 2017, 302 patients were enrolled and randomly assigned to receive semaglutide 1·0 mg or placebo (full analysis set), of whom 301 received at least one dose of treatment (safety analysis set). One patient was assigned to semaglutide but was not treated (reason unknown). 294 (97·4%) patients completed the trial and 267 (88·4%) completed treatment. Baseline characteristics were generally comparable between groups. In addition to randomised medication and SGLT-2 inhibitor, 216 (71·5%) patients were taking metformin and 39 (12·9%) were taking sulphonylurea. Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001). 356 adverse events were reported by 104 (69·3%) patients in the semaglutide group, and 247 adverse events were reported by 91 (60·3%) patients in the placebo group. Gastrointestinal adverse events were most common and were reported in 56 (37·3%) patients in the semaglutide group and 20 (13·2%) in the placebo group. Serious adverse events occurred in seven (4·7%) patients in the semaglutide group and six (4·0%) in the placebo group. Severe or blood glucose-confirmed hypoglycaemic events were reported in four patients on semaglutide (2·7%). 16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group. There were no deaths during the trial.
INTERPRETATION


Adding semaglutide to SGLT-2 inhibitor therapy significantly improves glycaemic control and reduces bodyweight in patients with inadequately controlled type 2 diabetes, and is generally well tolerated.
FUNDING


Novo Nordisk.",2019,Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001).,"['patients with inadequately controlled type 2 diabetes', '16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group', 'Adults with type 2 diabetes and HbA 1c  7·0', '294', 'Between March 15, and Dec 4, 2017, 302 patients']","['placebo', 'SGLT-2 inhibitor', 'metformin', 'SGLT-2 inhibitor therapy', 'subcutaneous semaglutide 1·0 mg or volume-matched placebo', 'semaglutide 1·0 mg or placebo', 'semaglutide or placebo and 4 weeks of 0·5 mg semaglutide or placebo', 'sulphonylurea']","['Gastrointestinal adverse events', 'change in bodyweight', 'Severe or blood glucose-confirmed hypoglycaemic events', 'adverse events', 'change in HbA 1c', '356 adverse events', 'efficacy and safety', 'glycaemic control and reduces bodyweight', 'Serious adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",302.0,0.598547,Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001).,"[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: zinman@lunenfeld.ca.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Bhosekar', 'Affiliation': 'Novo Nordisk, Bengaluru, India.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Albany Medical Center Division of Community Endocrinology, Albany, NY, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ludvik', 'Affiliation': '1st Medical Department and Karl Landsteiner Institute for Obesity and Metabolic Disorders, Rudolfstiftung Hospital, Vienna, Austria.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Thielke', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thrasher', 'Affiliation': 'Medical Investigations, Inc, Little Rock, AR, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Woo', 'Affiliation': 'University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30066-X']
1248,29855331,"The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial.","BACKGROUND


Dengue and other arboviruses transmitted by Aedes aegypti mosquitoes, including Zika and chikungunya, present an increasing public health challenge in tropical regions. Current vector control strategies have failed to curb disease transmission, but continue to be employed despite the absence of robust evidence for their effectiveness or optimal implementation. The World Mosquito Program has developed a novel approach to arbovirus control using Ae. aegypti stably transfected with Wolbachia bacterium, with a significantly reduced ability to transmit dengue, Zika and chikungunya in laboratory experiments. Modelling predicts this will translate to local elimination of dengue in most epidemiological settings. This study protocol describes the first trial to measure the efficacy of Wolbachia in reducing dengue virus transmission in the field.
METHODS/DESIGN


The study is a parallel, two-arm, non-blinded cluster randomised controlled trial conducted in a single site in Yogyakarta, Indonesia. The aim is to determine whether large-scale deployment of Wolbachia-infected Ae. aegypti mosquitoes leads to a measurable reduction in dengue incidence in treated versus untreated areas. The primary endpoint is symptomatic, virologically confirmed dengue virus infection of any severity. The 26 km 2  study area was subdivided into 24 contiguous clusters, allocated randomly 1:1 to receive Wolbachia deployments or no intervention. We use a novel epidemiological study design, the cluster-randomised test-negative design trial, in which dengue cases and arbovirus-negative controls are sampled concurrently from among febrile patients presenting to a network of primary care clinics, with case or control status classified retrospectively based on the results of laboratory diagnostic testing. Efficacy is estimated from the odds ratio of Wolbachia exposure distribution (probability of living in a Wolbachia-treated area) among virologically confirmed dengue cases compared to test-negative controls. A secondary per-protocol analysis allows for individual Wolbachia exposure levels to be assessed to account for movements outside the cluster and the heterogeneity in local Wolbachia prevalence among treated clusters.
DISCUSSION


The findings from this study will provide the first experimental evidence for the efficacy of Wolbachia in reducing dengue incidence. Together with observational evidence that is accumulating from pragmatic deployments of Wolbachia in other field sites, this will provide valuable data to estimate the effectiveness of this novel approach to arbovirus control, inform future cost-effectiveness estimates, and guide plans for large-scale deployments in other endemic settings.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier: NCT03055585 . Registered on 14 February 2017.",2018,"aegypti stably transfected with Wolbachia bacterium, with a significantly reduced ability to transmit dengue, Zika and chikungunya in laboratory experiments.","['The 26 km 2  study area was subdivided into 24 contiguous clusters', 'febrile patients presenting to a network of primary care clinics, with case or control status classified retrospectively based on the results of laboratory diagnostic testing']","['Wolbachia deployments or no intervention', 'Wolbachia-infected Ae', 'Wolbachia']","['symptomatic, virologically confirmed dengue virus infection of any severity']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205283', 'cui_str': 'Contiguous (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0752001', 'cui_str': 'Wolbachia'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011315', 'cui_str': 'Breakbone Fever Virus'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.10741,"aegypti stably transfected with Wolbachia bacterium, with a significantly reduced ability to transmit dengue, Zika and chikungunya in laboratory experiments.","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Anders', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Melbourne, Australia. katie.anders@worldmosquito.org.'}, {'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Indriani', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Riris Andono', 'Initials': 'RA', 'LastName': 'Ahmad', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Warsito', 'Initials': 'W', 'LastName': 'Tantowijoyo', 'Affiliation': 'Eliminate Dengue Project, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Eggi', 'Initials': 'E', 'LastName': 'Arguni', 'Affiliation': 'Eliminate Dengue Project, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Bekti', 'Initials': 'B', 'LastName': 'Andari', 'Affiliation': 'Eliminate Dengue Project, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'School of Public Health, University of California, Berkeley, USA.'}, {'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Rances', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Melbourne, Australia.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': ""O'Neill"", 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cameron P', 'Initials': 'CP', 'LastName': 'Simmons', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Melbourne, Australia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Eliminate Dengue Project, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",Trials,['10.1186/s13063-018-2670-z']
1249,30824364,Tuberculosis case detection by trained inmate peer educators in a resource-limited prison setting in Ethiopia: a cluster-randomised trial.,"BACKGROUND


To improve tuberculosis case detection, interventions that are feasible with available resources are needed. We investigated whether involving trained prison inmates in a tuberculosis control programme improved tuberculosis case detection, shortened pre-treatment symptom duration, and increased treatment success in a resource-limited prison setting in Ethiopia.
METHODS


In this cluster-randomised trial we randomly assigned prisons in the regions Amhara and Tigray of Ethiopia to an intervention group or a control group, after matching them into pairs based on their geographical proximity and size. Larger prisons were considered eligible whereas smaller prisons were excluded. We selected three to six prison inmates in each intervention prison. The recruited prison inmates who received a 3-day training course and were capable of identifying presumptive tuberculosis cases then provided health education to all other prison inmates about tuberculosis prevention and control every 2 weeks for 1 year. They also actively searched for symptomatic prison inmates and undertook routine symptom-based tuberculosis screening. The control prisons followed the existing passive case finding system. The primary outcome was the mean case detection rate at the end of the year, measured at cluster (prison) level. This trial is registered at ClinicalTrials.gov, number NCT02744521.
FINDINGS


We randomly assigned 16 prisons with a total population of 18 032 inmates to either the intervention group (n=8) or the control group (n=8) from April 1, 2016, to March 31, 2017. During the 1-year study period, 75 new tuberculosis cases (1% of 8874 total inmates) were detected in the intervention prisons and 25 new cases (<1% of 9158 total inmates) were detected in the control prisons. The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
INTERPRETATION


Involving trained inmate peer educators in the tuberculosis control programme in Ethiopian prisons significantly improved the tuberculosis case detection rate. The findings have important implications for clinical and public health policy, particularly in prisons of low-income countries where tuberculosis burden is high and the recommended tuberculosis diagnostic and treatment algorithms have generally not been implemented.
FUNDING


Nuffic, Mekelle University.",2019,"The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
","['recruited prison inmates who received a', '16 prisons with a total population of 18\u2008032 inmates to either the intervention group (n=8) or the control group (n=8) from April 1, 2016, to March 31, 2017', '75 new tuberculosis cases (1% of 8874 total inmates', 'Tuberculosis case detection by trained inmate peer educators in a resource-limited prison setting in Ethiopia', 'trained prison inmates', 'six prison inmates in each intervention prison']",['3-day training course and were capable of identifying presumptive tuberculosis cases then provided health education to all other prison inmates about tuberculosis prevention and control every 2 weeks for 1 year'],"['mean case detection rate at the end of the year, measured at cluster (prison) level', 'tuberculosis case detection', 'tuberculosis case detection rate', 'mean case detection rate']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]",16.0,0.209595,"The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
","[{'ForeName': 'Kelemework', 'Initials': 'K', 'LastName': 'Adane', 'Affiliation': 'Department of Medical Microbiology and Immunology, College of Health Sciences, Mekelle University, Mekelle, Ethiopia; Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands. Electronic address: ingoldmlt@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Spigt', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands; Department of Community Medicine, General Practice Research Unit, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Dinant', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30477-7']
1250,30852786,Effects of a Question Prompt Sheet on the Oncologist-Patient Relationship: a Multi-centred Randomised Controlled Trial in Breast Cancer.,"This study assessed the effect of a question prompt sheet (QPS) on the oncologist-patient relationship as compared with a question listing (QL). In particular, the differences in difficulties perceived by the oncologist during the consultation and in the patient's experience of the therapeutic aspects of the relationship were assessed. A total of 324 patients with a recent diagnosis of early stage breast cancer were involved in the study. The results showed that 15.7% of patients were perceived as 'difficult' by the oncologists. The proportion of 'difficult' patients varied in the two groups: 20.6% in the QPS group versus 11.8% in the QL group. The results also showed that the higher the difficulty perceived by oncologists, the lower the satisfaction of patients for their relationship with the oncologists during the consultation (r = - .135, p = .033). It is likely that the higher level of difficulty perceived by the oncologist in the QPS group may be connected with the pre-prepared list of evidence-based questions. Further research is needed to understand which components of the interventions, relating to the patient, the oncologist or their interaction, really promote patient participation in cancer setting. Trial registration: ClinicalTrials.gov NCT01510964. https://clinicaltrials.gov/ct2/show/NCT01510964.",2020,The proportion of 'difficult' patients varied in the two groups: 20.6% in the QPS group versus 11.8% in the QL group.,"['324 patients with a recent diagnosis of early stage breast cancer', 'Breast Cancer']","['QPS', 'question prompt sheet (QPS', 'Question Prompt Sheet']",[],"[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}]",[],324.0,0.0531763,The proportion of 'difficult' patients varied in the two groups: 20.6% in the QPS group versus 11.8% in the QL group.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Buizza', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Clinical Psychology, University of Brescia, Viale Europa 11, 25123, Brescia, Italy. chiara.buizza@unibs.it.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ghilardi', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Clinical Psychology, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mazzardi', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Clinical Psychology, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Barbera', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Clinical Psychology, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Fremondi', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Clinical Psychology, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bottacini', 'Affiliation': 'Department of Public Health and Community Medicine, Section of Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale LA. Scuro 10, 37134, Verona, Italy.'}, {'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Mazzi', 'Affiliation': 'Department of Public Health and Community Medicine, Section of Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale LA. Scuro 10, 37134, Verona, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Goss', 'Affiliation': 'Department of Public Health and Community Medicine, Section of Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale LA. Scuro 10, 37134, Verona, Italy.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01505-6']
1251,30846472,Effects of exercise and airway clearance (positive expiratory pressure) on mucus clearance in cystic fibrosis: a randomised crossover trial.,"Exercise improves mucus clearance in people without lung disease and those with chronic bronchitis. No study has investigated exercise alone for mucus clearance in cystic fibrosis (CF). The aim of this study was to compare the effects of treadmill exercise to resting breathing and airway clearance with positive expiratory pressure (PEP) therapy on mucus clearance in adults with CF.This 3-day randomised, controlled, crossover trial included 14 adults with mild to severe CF lung disease (forced expiratory volume in 1 s % predicted 31-113%). Interventions were 20 min of resting breathing (control), treadmill exercise at 60% of the participant's peak oxygen consumption or PEP therapy (including huffing and coughing). Mucus clearance was measured using the radioaerosol technique and gamma camera imaging.Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI -6- -8). When comparing treadmill exercise to PEP therapy, there were no significant differences in mucus clearance from the intermediate and peripheral lung regions, but significantly less clearance from the central lung region (likely reflecting the huffing and coughing that was only in PEP therapy).It is recommended that huffing and coughing are included to maximise mucus clearance with exercise.",2019,"Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI","['adults with CF.This 3-day randomised, controlled, crossover trial included 14\xa0adults with mild to severe CF lung disease (forced expiratory volume in 1\u2005s % predicted 31-113', 'people without lung disease and those with chronic bronchitis', 'cystic fibrosis (CF', 'cystic fibrosis']","['treadmill exercise to resting breathing and airway clearance with positive expiratory pressure (PEP) therapy', 'exercise alone', 'Treadmill exercise', ""20\u2005min of resting breathing (control), treadmill exercise at 60% of the participant's peak oxygen consumption or PEP therapy (including huffing and coughing"", 'Exercise', 'exercise and airway clearance (positive expiratory pressure']","['Mucus clearance', 'whole lung mucus clearance', 'mucus clearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0008677', 'cui_str': 'Bronchitis, Chronic'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0419023', 'cui_str': 'Positive end expiratory pressure ventilation therapy, initiation and management'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0566520', 'cui_str': 'Does huff (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]",,0.0643205,"Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI","[{'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Dwyer', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia tiffany.dwyer@sydney.edu.au.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Daviskas', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Rahizan', 'Initials': 'R', 'LastName': 'Zainuldin', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Verschuer', 'Affiliation': 'Dept of PET and Nuclear Medicine, Royal\xa0Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Dept of PET and Nuclear Medicine, Royal\xa0Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Peter T P', 'Initials': 'PTP', 'LastName': 'Bye', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}]",The European respiratory journal,['10.1183/13993003.01793-2018']
1252,30864532,Home treatment for acute mental healthcare: randomised controlled trial.,"BACKGROUND


Home treatment has been proposed as an alternative to acute in-patient care for mentally ill patients. However, there is only moderate evidence in support of home treatment.
AIMS


To test whether and to what degree home treatment services would enable a reduction (substitution) of hospital use.
METHOD


A total of 707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital, were randomly allocated to either a service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov: NCT02322437).
RESULTS


The mean number of hospital days per patient within 24 months after the index crisis necessitating hospital admission (primary outcome) was reduced by 30.4% (mean 41.3 v. 59.3, P<0.001) when a home treatment team was available (intention-to-treat analysis). Regarding secondary outcomes, average overall treatment duration (hospital days + home treatment days) per patient (mean 50.4 v. 59.3, P = 0.969) and mean number of hospital admissions per patient (mean 1.86 v. 1.93, P = 0.885) did not differ statistically significantly between the experimental and control groups within 24 months after the index crisis. There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
CONCLUSIONS


Home treatment services can reduce hospital use among severely ill patients in acute crises and seem to result in comparable clinical/social outcomes and patient satisfaction as standard in-patient care.",2020,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
","['707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital', 'severely ill patients in acute crises', 'mentally ill patients', 'acute mental healthcare']",['service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov'],"['average overall treatment duration (hospital days + home treatment days) per patient', 'patient satisfaction with care (Perception of Care questionnaire', 'mean number of hospital admissions', 'mean number of hospital days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025360', 'cui_str': 'Mentally Ill'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",707.0,0.0771763,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
","[{'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Stulz', 'Affiliation': 'Head of Research, Integrated Psychiatric Services Winterthur - Zurcher Unterland; Senior Researcher (Former Head of Research), Psychiatric Services Aargau; and Research Associate, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wyder', 'Affiliation': 'Research Associate, Psychiatric Services Aargau; and Former PhD Student, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lienhard', 'Initials': 'L', 'LastName': 'Maeck', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hilpert', 'Affiliation': 'Deputy Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Lerzer', 'Affiliation': 'Deputy Head of Nursing Services, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Zander', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Associate Professor, Department of Psychology, University of Berne; and Head Researcher, Division of Psychosomatic Medicine, Department of Neurology, Inselspital, University Hospital Berne, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schnyder', 'Affiliation': 'Emeritus Professor, University of Zurich, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Hepp', 'Affiliation': 'Medical Director, Integrated Psychiatric Services Winterthur - Zurcher Unterland, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.31']
1253,30846474,Effect of long-term corticosteroid treatment on microRNA and gene-expression profiles in COPD.,"The aim was to investigate whether microRNA (miRNA) expression is modulated by inhaled corticosteroid (ICS) treatmentWe performed genome-wide miRNA analysis on bronchial biopsies of 69 moderate/severe chronic obstructive pulmonary disease (COPD) patients at baseline and after 6- and 30-month treatment with the ICS fluticasone propionate or placebo. The effect of ICS on miRNA expression was validated in differentiated primary bronchial epithelial cultures, and functional studies were conducted in BEAS-2B cells. MiRNAs affected by ICS and their predicted targets were compared to an independent miRNA dataset of bronchial brushings from COPD patients and healthy controls.Treatment with ICS for both 6 and 30 months significantly altered the expression of four miRNAs, including miR-320d, which was increased during ICS treatment compared with placebo. The ICS-induced increase of miR-320d was confirmed in primary airway epithelial cells. MiR-320d negatively correlated targets were enriched for pro-inflammatory genes and were increased in the bronchial brushes of patients with lower lung function in the independent dataset. Overexpression of miR-320d in BEAS-2B cells dampened cigarette smoke extract-induced pro-inflammatory activity  via  inhibition of nuclear factor-κB.Collectively, we identified miR-320d as a novel mediator of ICS, regulating the pro-inflammatory response of the airway epithelium.",2019,MiR-320d negatively correlated targets were enriched for pro-inflammatory genes and were increased in the bronchial brushes of patients with lower lung function in the independent dataset.,"['69 moderate/severe chronic obstructive pulmonary disease (COPD) patients at baseline and after 6- and 30-month treatment with the', 'COPD']","['ICS', 'ICS fluticasone propionate or placebo', 'placebo', 'inhaled corticosteroid (ICS']","['expression of four miRNAs, including miR-320d']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.189728,MiR-320d negatively correlated targets were enriched for pro-inflammatory genes and were increased in the bronchial brushes of patients with lower lung function in the independent dataset.,"[{'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases, Groningen, The Netherlands a.faiz@umcg.nl.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Steiling', 'Affiliation': 'Boston University School of Medicine, Division of Computational Biomedicine, Dept of Medicine, Boston, MA, USA.'}, {'ForeName': 'Mirjam P', 'Initials': 'MP', 'LastName': 'Roffel', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Dirkje S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases, Groningen, The Netherlands.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Boston University School of Medicine, Division of Computational Biomedicine, Dept of Medicine, Boston, MA, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lenburg', 'Affiliation': 'Boston University School of Medicine, Division of Computational Biomedicine, Dept of Medicine, Boston, MA, USA.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Borggrewe', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Eijgenraam', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Marnix R', 'Initials': 'MR', 'LastName': 'Jonker', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': 'University of Groningen, University Medical Center Groningen, GRIAC (Groningen Research Institute for Asthma and COPD), Groningen, The Netherlands.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Pouwels', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases, Groningen, The Netherlands.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Division of Computational Biomedicine, Dept of Medicine, Boston, MA, USA.'}, {'ForeName': 'Yuriy O', 'Initials': 'YO', 'LastName': 'Alekseyev', 'Affiliation': 'Boston University School of Medicine, Dept of Pathology and Laboratory Medicine, Boston, MA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'Cancer Imaging, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Hiemstra', 'Affiliation': 'Leiden University Medical Center, Dept of Pulmonary Diseases, Leiden, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Sterk', 'Affiliation': 'University of Amsterdam, Dept of Respiratory Medicine, F5-259, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pathology and Medical Biology, Groningen, The Netherlands.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Heijink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases, Groningen, The Netherlands.'}]",The European respiratory journal,['10.1183/13993003.01202-2018']
1254,30850310,Examining the Effects of an Adolescent Pregnancy Prevention Program by Risk Profiles: A More Nuanced Approach to Program Evaluation.,"PURPOSE


The objective of the study was to examine whether latent class analysis (LCA) could (1) identify distinct subgroups of youth characterized by multiple risk and protective factors for early sexual initiation and (2) allow for a more nuanced assessment of the effects of a middle school program to prevent teen pregnancy/HIV/sexually transmitted infection.
METHODS


LCA was applied to data from the baseline (seventh grade) sample of 1,693 sexually inexperienced students participating in a randomized controlled trial of It's Your Game…Keep It Real in Harris County, Texas. Multilevel analysis was applied within subgroups defined by the latent classes to assess for potential differential program effects.
RESULTS


LCA identified 3 distinct profiles of youth: family disruption, other language household, and frequent religious attendance. Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
CONCLUSIONS


Application of LCA may hold promise for conducting more nuanced evaluations and refinements of behavior change interventions for youth.",2019,"Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
","[""1,693 sexually inexperienced students participating in a randomized controlled trial of It's Your Game""]","['Adolescent Pregnancy Prevention Program', 'LCA', 'latent class analysis (LCA']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0032968', 'cui_str': 'Pregnancy, Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}]",[],1693.0,0.0322458,"Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Vasilenko', 'Affiliation': 'Syracuse University, Department of Human Development and Family Science, Syracuse, New York. Electronic address: savasile@syr.edu.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Glassman', 'Affiliation': 'ETR Associates, Scotts Valley, California.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Kugler', 'Affiliation': 'Pennsylvania State University, Department of Biobehavioral Health and the Methodology Center, University Park, Pennsylvania.'}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Peskin', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Markham', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Susan Tortolero', 'Initials': 'ST', 'LastName': 'Emery', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Karin K', 'Initials': 'KK', 'LastName': 'Coyle', 'Affiliation': 'ETR Associates, Scotts Valley, California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.12.003']
1255,30859465,Mindfulness-based emotional eating awareness training: taking the emotional out of eating.,"PURPOSE


Emotional eating is important to study and address because it predicts poor outcome in weight loss interventions. Interventions have only touched the surface in terms of addressing emotional eating. Mindfulness approaches can address emotional eating by modification of emotion regulation and appetitive traits. The current study involved development of an emotional eating-specific mindfulness intervention and assessment of its effect on appetitive traits associated with emotional eating.
METHODS


Participants (n = 14; age M = 29 years; 90% female) completed baseline and end-of-intervention self-report measures of emotional eating, food-cue reactivity, mindfulness, intuitive eating, emotional impulse regulation, stress, and a behavioural measure of inhibitory control. During the 6-week intervention, mindfulness meditation skills were taught weekly embedded in a psycho-educational curriculum about emotional eating.
RESULTS


Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05; d: 0.58-1.54). Changes in emotional eating approached significance (p = 0.075, d = 0.66).
CONCLUSION


The intervention purposefully did not focus on weight loss and recruited participants who had self-declared difficulties with emotional eating. The positive outcomes suggest that intervening with mindfulness training before weight loss is attempted has the potential to change psychological factors that underpin overeating and undermine weight loss efforts. The study provides proof of principle as a basis to design a randomized control trial to assess rigorously the effectiveness of the intervention as a precursor to a weight loss intervention.
LEVEL OF EVIDENCE


Level IV, uncontrolled trial.",2020,"RESULTS


Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05;","['and recruited participants who had self-declared difficulties with emotional eating', 'Participants (n\u2009=\u200914; age M\u2009']","['emotional eating-specific mindfulness intervention', 'Mindfulness-based emotional eating awareness training']","['weight loss', 'emotional eating, food-cue reactivity, mindfulness, intuitive eating, emotional impulse regulation, stress, and a behavioural measure of inhibitory control', 'food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0219113,"RESULTS


Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05;","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lattimore', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, L3 3AF, UK. p.j.lattimore@ljmu.ac.uk.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00667-y']
1256,30848697,Myocardial protection and clinical outcomes in Tetralogy of Fallot patients undergoing intracardiac repair: a randomized study of two cardioplegic techniques.,"BACKGROUND


Myocardial protection in Tetralogy of Fallot patients undergoing intracardiac repair is suboptimal due to hypertrophied right ventricle. Hypertrophied myocardium is more susceptible to poor myocardial preservation because of inadequate capillary density as compared to the myocytes. There is a capillary to myocyte ratio mismatch. But del Nido Cardioplegia owing to its less viscosity is able to get more evenly distributed under hypothermic cardiopulmonary bypass as opposed to blood Cardioplegia. We hypothesized that the del Nido Cardioplegia technique, would be beneficial in myocardial protection because of its composition and method of delivery, leading into better early and late clinical outcomes in patients undergoing Tetralogy of Fallot repair as compared to blood cardioplegia reconstituted using St Thomas Cardioplegia solution. The objective of the study was to identify a better technique of myocardial preservation in Tetralogy of Fallot patient.
METHODS


In total, 56 Tetralogy of Fallot patients undergoing intracardiac repair under mild hypothermic cardiopulmonary bypass were randomly allocated to receive antegrade Cardioplegia with either standard blood Cardioplegia (Group I) or del Nido Cardioplegia (Group II). Preoperative as well as postoperative data including echocardiographic parameters for right ventricle functions, creatine kinase MB level, inotropic requirement, mechanical ventilation duration, intensive care unit stay and hospital mortality were evaluated.
RESULTS


Inotropic score in the first 24 hours postoperatively was significantly lower in Group II compared to Group I (13.4 ± 7.2 vs. 21.2 ± 9.6, p = 0.003). Creatine kinase MB level (ng/mL) was comparable between the groups. Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
CONCLUSION


Del Nido Cardioplegia is equally efficacious in providing myocardial protection during intracardiac repair under mild hypothermic cardiopulmonary bypass in Tetralogy of Fallot patients as compared to blood Cardioplegia solution with the added benefit of reducing inotropic requirement in first 24 hours postoperative period.",2019,"Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
","['patients undergoing Tetralogy of Fallot repair', '56 Tetralogy of Fallot patients undergoing intracardiac repair under mild hypothermic cardiopulmonary bypass', 'Tetralogy of Fallot patient', 'Tetralogy of Fallot patients undergoing', 'intracardiac repair under mild hypothermic cardiopulmonary bypass in Tetralogy of Fallot patients', 'Tetralogy of Fallot patients undergoing intracardiac repair']","['intracardiac repair', 'antegrade Cardioplegia with either standard blood Cardioplegia (Group I) or del Nido Cardioplegia']","['Echocardiographic parameters for right ventricle functions', 'Inotropic score', 'postoperative data including echocardiographic parameters for right ventricle functions, creatine kinase MB level, inotropic requirement, mechanical ventilation duration, intensive care unit stay and hospital mortality', 'Creatine kinase MB level (ng/mL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot (procedure)'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005768'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",56.0,0.0437195,"Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
","[{'ForeName': 'Sunder Lal', 'Initials': 'SL', 'LastName': 'Negi', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Banashree', 'Initials': 'B', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rana Sandeep', 'Initials': 'RS', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Goverdhan Dutt', 'Initials': 'GD', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Perfusion,['10.1177/0267659119828890']
1257,30798084,Continuation versus discontinuation of first-line chemotherapy in patients with metastatic squamous cell oesophageal cancer: A randomised phase II trial (E-DIS).,"PURPOSE


The role of chemotherapy has not been established in the treatment of metastatic squamous cell oesophageal cancer (mESCC).
PATIENTS AND METHODS


E-DIS is a discontinuation trial, aimed at estimating efficacy, quality of life and safety of chemotherapy continuation (CT-CONT) in patients with mESCC who are free from progression after a selection phase of chemotherapy. The primary end-point was overall survival.
RESULTS


Sixty-seven patients were randomised. The 9-month survival rate was 50% (85% confidence interval [CI]: 37-62%) and 48% (85% CI: 35-60%) in the CT-CONT arm and in the chemotherapy discontinuation (CT-DISC) arm, respectively. The time until definitive deterioration of the global health status (European Organisation for Research and Treatment of Cancer [EORTC] core quality of life questionnaire) was 6.6 months (95% CI: 3.3-12.4) for the CT-CONT arm and 4.2 months (95% CI: 2.9-6.3) for the CT-DISC arm, with a hazard ratio (HR CT-DISC/CT-CONT ) = 1.44 (95% CI: 0.82-2.53). We observed a beneficial trend in favour of CT-CONT (HR > 1) for most dimensions, including an improvement for three dimensions (dysphagia, eating and oesophageal pain) of the EORTC Oesophageal Cancer Module QLQ-OES18.
CONCLUSION


CT-CONT provides an overall survival rate that is similar to CT-DISC. E-DIS trial provides valuable data to support shared decision-making between physicians and patients regarding CT-CONT/DISC.",2019,"The 9-month survival rate was 50% (85% confidence interval [CI]: 37-62%) and 48% (85% CI: 35-60%) in the CT-CONT arm and in the chemotherapy discontinuation (CT-DISC) arm, respectively.","['patients with metastatic squamous cell oesophageal cancer', 'patients with mESCC who are free from progression after a selection phase of chemotherapy', 'Sixty-seven patients were randomised', 'metastatic squamous cell oesophageal cancer (mESCC']","['CT-CONT', 'Continuation versus discontinuation of first-line chemotherapy', 'chemotherapy', 'chemotherapy continuation (CT-CONT']","['three dimensions (dysphagia, eating\xa0and oesophageal pain', 'time until definitive deterioration of the global health status (European Organisation for Research and Treatment of Cancer [EORTC] core quality of life questionnaire', '9-month survival rate', 'overall survival rate', 'efficacy, quality of life and safety', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0221727', 'cui_str': 'Pain in esophagus (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",67.0,0.0766427,"The 9-month survival rate was 50% (85% confidence interval [CI]: 37-62%) and 48% (85% CI: 35-60%) in the CT-CONT arm and in the chemotherapy discontinuation (CT-DISC) arm, respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': ""Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France; Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France; FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France. Electronic address: antoine.adenis@icm.unicancer.fr.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Etienne', 'Affiliation': ""Centre Armoricain Radiothérapie Imagerie Oncologie, Hôpital Privé des Côtes d'Armor, Plérin, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': ""Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Francois', 'Affiliation': ""Département d'Oncologie Médicale, Centre Antoine Lacassagne, Nice, France.""}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Galais', 'Affiliation': ""Département d'Oncologie Médicale, Centre Francois Baclesse, Caen, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ben Abdelghani', 'Affiliation': ""Département d'Oncologie Médicale, Centre Paul Strauss, Strasbourg, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Michel', 'Affiliation': ""Service d'Hépato-Gastroenterologie, Charles Nicolle University Hospital, Rouen, France.""}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': ""Institut de Cancérologie et d'Hématologie, Morvan University Hospital, Brest, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': ""Service d'Oncologie Digestive et d'Hépato-Gastroentrologie, La Timone University Hospital, Marseille, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Conroy', 'Affiliation': ""Département d'Oncologie Médicale, Institut de Cancérologie de Lorraine, Université de Lorraine, Vandœuvre-lès-Nancy, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': ""Département d'Oncologie Médicale, Centre Georges-Francois Leclerc, Dijon, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': ""Service d'Hépato-Gastroenterologie, Francois Mitterrand University Hospital, Dijon.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': ""Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Samalin', 'Affiliation': ""Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hiret', 'Affiliation': ""Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delaine-Clisant', 'Affiliation': ""Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France; Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France; Univ. Lille, Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': ""Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France; Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France; Univ. Lille, Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': ""Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France; CESP, INSERM, Paris-Sud, Paris-Saclay University, 94805 Villejuif, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.01.016']
1258,30839416,"Phase 2, Randomized, Dose-finding Studies of Omidenepag Isopropyl, a Selective EP2 Agonist, in Patients With Primary Open-angle Glaucoma or Ocular Hypertension.","PRéCIS:: Three randomized, multicenter studies demonstrated the stable intraocular pressure-lowering effects and tolerability of omidenepag isopropyl in patients with primary open-angle glaucoma and ocular hypertension; 0.002% was identified as the optimal dose for further investigation.
PURPOSE


The purpose of this study was to assess the safety and efficacy of omidenepag isopropyl, a selective EP2 agonist, and to determine the optimal dose for further investigation.
PATIENTS AND METHODS


Three randomized, controlled, masked, multicenter studies were conducted in United States (study 1, NCT01868126; study 2, NCT02179008) and Japan (study 3, NCT02623738). Patients were randomized to 1 of 7 omidenepag isopropyl concentrations (0.0003%, 0.001%, 0.0012%, 0.0016%, 0.002%, 0.0025%, and 0.003%), latanoprost (0.005%), or placebo, 1 drop once daily for 28 days (studies 1 and 3) or 90 days (study 2). Primary endpoints were the observed mean diurnal intraocular pressure (IOP) and IOP at each time point on the final visit (studies 1 and 2) and change from baseline in mean diurnal IOP at week 4 (study 3).
RESULTS


IOP-lowering effects of omidenepag isopropyl 0.0003% to 0.002% increased dose-dependently. Omidenepag isopropyl 0.002% and 0.0025% resulted in clinically relevant mean diurnal IOP reductions from baseline that were similar to those of latanoprost and superior to placebo (P<0.005). Maximum reductions had already been achieved by week 1, and stable IOP-lowering effects were observed at all postbaseline time points up to 3 months. Most adverse events (AEs) were mild. Conjunctival hyperemia was the most frequently reported AE, the incidence of which increased dose-dependently. The safety profiles of omidenepag isopropyl 0.002% and 0.0025% were similar, with a slightly lower incidence of AEs in the 0.002% group.
CONCLUSIONS


Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.",2019,"CONCLUSIONS


Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.","['Patients With Primary Open-angle Glaucoma or Ocular Hypertension', 'patients with primary open-angle glaucoma and ocular hypertension']","['omidenepag isopropyl', 'placebo', 'latanoprost', 'Omidenepag Isopropyl, a Selective EP2 Agonist', 'omidenepag isopropyl, a selective EP2 agonist']","['safety and efficacy', 'Conjunctival hyperemia', 'mean diurnal IOP reductions', 'stable IOP-lowering effects', 'mean diurnal intraocular pressure (IOP) and IOP at each time point on the final visit (studies 1 and 2) and change from baseline in mean diurnal IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.165393,"CONCLUSIONS


Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Ophthalmology, University of Tokyo, Bunkyo-ku.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, CA.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001221']
1259,32022282,"A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.","AIMS


Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.
METHODS


Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US- and EU-references in healthy adults.
RESULTS


Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.
CONCLUSIONS


Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.",2020,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","['healthy adults', 'healthy volunteers']","['Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim', 'Sandoz biosimilar pegfilgrastim with US- and EU-references', 'pegfilgrastim biosimilar with its US- and EU-reference biologics', 'Biosimilar pegfilgrastim']","['pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'Pharmacokinetic (PK) and pharmacodynamic (PD) similarity', 'safety, local tolerability, and immunogenicity', 'Safety, immunogenicity, and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",,0.248203,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellon', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Skerjanec', 'Affiliation': 'Sandoz AG, Novartis, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Velinova', 'Affiliation': 'PRAHS, Groningen, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRAHS, Lenexa, KS, USA.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'PRAHS, Salt Lake City, UT, USA.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'PRAHS, Marlton, NJ, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Tempe, AZ, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, NE, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schussler', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schier-Mumzhiu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Gattu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sven D', 'Initials': 'SD', 'LastName': 'Koch', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Schelcher', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Miryana', 'Initials': 'M', 'LastName': 'Dobreva', 'Affiliation': 'Sandoz, Novartis, Sofia, Bulgaria.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Boldea', 'Affiliation': 'Sandoz Pharma Services Romania SRL, Novartis, Bucharest, Romania.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Gordon P', 'Initials': 'GP', 'LastName': 'Otto', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14226']
1260,30826468,The effect of content and tone of maternal evaluative feedback on self-cognitions and affect in young children.,"Feedback that young children receive from others can affect their emotions and emerging self-views. The current experiment tested the effect of negative content (criticism) and negative tone (hostile) of the feedback on children's affect, self-evaluations, and attributions. We also explored whether maternal history of depression and children's temperament moderated these relations. Participants were 152 mothers and children (48% girls) aged 4 and 5 years (M = 61.6 months, SD = 6.83). The task involved three scenarios enacted by dolls; a child doll made something (e.g., picture, house, numbers) that had a mistake (e.g., no windows on the house) and proudly showed it to the mother doll, who then gave feedback (standardized, audio recorded) to the child. Children were randomized to one of four maternal feedback conditions: negative or neutral content in either a negative or neutral tone. Negative content (criticism) produced significantly more negative affect and lower self-evaluations than neutral content. When the tone of the feedback was hostile, children of mothers who had been depressed during the children's lifetimes were significantly more likely to make internal attributions for mistakes than children of nondepressed mothers. In addition, among children with low temperamental negative affectivity, in the presence of negative tone, negative content significantly predicted more internal attributions for the errors. Findings are discussed in terms of understanding the role of evaluative feedback in children's emerging social cognitions and affect.",2019,Negative content (criticism) produced significantly more negative affect and lower self-evaluations than neutral content.,"['young children', 'Participants were 152 mothers and children (48% girls) aged 4 and 5\u202fyears (M\u202f=\u202f61.6\u202fmonths, SD\u202f=\u202f6.83']","['maternal evaluative feedback', 'negative content (criticism) and negative tone (hostile', 'maternal feedback conditions: negative or neutral content in either a negative or neutral tone']",['internal attributions'],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}]",152.0,0.0149701,Negative content (criticism) produced significantly more negative affect and lower self-evaluations than neutral content.,"[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Garber', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN 37203, USA. Electronic address: Judy.Garber@Vanderbilt.edu.'}, {'ForeName': 'Sherryl H', 'Initials': 'SH', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Brunwasser', 'Affiliation': 'School of Medicine, Vanderbilt University, Nashville, TN 37232, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Frankel', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Herrington', 'Affiliation': 'School of Medicine, Vanderbilt University, Nashville, TN 37232, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.01.017']
1261,30676200,Acute alcohol effects on impulsive choice in adolescents.,"BACKGROUND


Neurodevelopmental and alcohol-induced changes in decision-making have been proposed to critically influence impulsive behaviour in adolescents.
OBJECTIVE


This study tested the influence of acute alcohol administration on impulsive choice in adolescents.
METHODS


Fifty-four males aged 18-19 years were tested in a single-blind placebo-controlled cross-over design. During alcohol administration (infusion resulting in an arterial blood alcohol concentration of 80 mg%) and placebo condition (saline infusion), participants performed a task battery providing estimates of delay discounting, probability discounting for gains, for losses and loss aversion, and also rated subjectively experienced alcohol effects. Additionally, baseline alcohol consumption (Alcohol Use Disorders Identification Test, blood phosphatidylethanol levels), motives (Drinking Motive Questionnaire, Alcohol Expectancy Questionnaire and Obsessive Compulsive Drinking Scale), family history and self-report measures of impulsivity (Barratt Impulsiveness Scale, Substance Use Risk Profile Scale) were provided.
RESULTS


No overall effects of treatment on choice behaviour were found. However, individual differences were observed. In the alcohol condition, more impulsive choice tendencies for delay discounting were associated with higher subjectively experienced alcohol effects. Further, higher risk aversion for probabilistic gains and higher loss aversion during alcohol condition were related to higher levels of real-life alcohol consumption and a family history of alcohol problems, respectively. Finally, the time to make a decision was substantially shortened for choices involving negative prospects.
CONCLUSIONS


Contrary to common beliefs, acute alcohol intoxication did not generally incite impulsive decision-making. It rather appears that alcohol-induced behavioural changes in adolescents vary considerably depending on prior experiences and subjective effects of alcohol.",2019,No overall effects of treatment on choice behaviour were found.,"['adolescents', '\n\n\nFifty-four males aged 18-19 years']","['acute alcohol administration', 'placebo condition (saline infusion', 'placebo']","['baseline alcohol consumption (Alcohol Use Disorders Identification Test, blood phosphatidylethanol levels), motives (Drinking Motive Questionnaire, Alcohol Expectancy Questionnaire and Obsessive Compulsive Drinking Scale), family history and self-report measures of impulsivity (Barratt Impulsiveness Scale, Substance Use Risk Profile Scale', 'choice behaviour', 'delay discounting, probability discounting for gains, for losses and loss aversion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0005768'}, {'cui': 'C0070787', 'cui_str': 'phosphatidylethanol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0222045'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}]",54.0,0.0235237,No overall effects of treatment on choice behaviour were found.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bernhardt', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Obst', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Nebe', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Pooseh', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Friedrich M', 'Initials': 'FM', 'LastName': 'Wurst', 'Affiliation': '4 Psychiatric University Hospital, Basel, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Weinmann', 'Affiliation': '6 Institute of Forensic Medicine, Forensic Toxicology and Chemistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich S', 'Initials': 'US', 'LastName': 'Zimmermann', 'Affiliation': '1 Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118822063']
1262,30834652,"The effect of blood flow rate on dialysis recovery time in patients undergoing maintenance hemodialysis: A prospective, parallel-group, randomized controlled trial.","INTRODUCTION


A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from an HD session. Patients and caregivers identify fatigue as a high priority for improvement. However, evidence for practical interventions to improve recovery time from conventional in-center HD is lacking. The effect of blood flow rate reduction on dialysis recovery time (DRT) is unknown.
METHODS


Multicenter, single-blinded, randomized, parallel-design controlled trial of blood flow rate reduction vs. usual care. One-hundred two patients with ESRD undergoing maintenance HD in 18 centers with baseline DRT of greater than 6 hours were included as subjects. The intervention was a blood flow rate reduction of 100 mL/min, to a minimum of 300 mL/min. The primary outcome was the between-group difference in change in DRT. Secondary outcomes were changes in London Evaluation of Illness (LEVIL) survey responses from baseline.
FINDINGS


Baseline median DRT was 720 (IQR 360-1013) minutes in controls and 720 (IQR 360-1106) minutes in the intervention group. DRT decreased in both groups. Mean change from baseline (95% confidence interval) at Week 4 in the study was -324 (-473, -175) minutes in the control group and -120 (-329, 90) minutes in the intervention group. The change from baseline was more profound in the control group (P = 0.05). Secondary outcomes of measures of quality of life reported on the LEVIL survey showed more improvement in patients' feelings of general well-being in the control group (P = 0.01). Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
DISCUSSION


Blood flow rate reduction did not improve DRT over usual care. Though more work needs to be done to address patient-reported fatigue, a significant positive impact may not be achieved without substantial changes in dialysis prescription.",2019,"Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
","['One-hundred two patients with ESRD undergoing maintenance HD in 18 centers with baseline DRT of greater than 6 hours were included as subjects', 'patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from an HD session', 'patients undergoing maintenance hemodialysis']","['blood flow rate reduction vs. usual care', 'blood flow rate', 'blood flow rate reduction']","['changes in London Evaluation of Illness (LEVIL) survey responses from baseline', 'change in DRT', 'quality of life', 'blood flow rate reduction', 'DRT', ""patients' feelings of general well-being"", 'pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite', 'dialysis recovery time (DRT']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",102.0,0.0922163,"Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Duggal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hussein', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Reiterman', 'Affiliation': 'Medical Clinical Affairs, Satellite Healthcare, California, San Jose, USA.'}, {'ForeName': 'Sumi J', 'Initials': 'SJ', 'LastName': 'Sun', 'Affiliation': 'Medical Clinical Affairs, Satellite Healthcare, California, San Jose, USA.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Abra', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12741']
1263,30699443,Effects of Homeopathic Preparations of Mercurius corrosivus on the Growth Rate of Severely Mercury-Stressed Duckweed Lemna gibba L.,"BACKGROUND


We developed a bioassay with mercury-stressed duckweed ( Lemna gibba  L.) to study potential effects of homeopathically potentised mercury(II) chloride ( Mercurius corrosivus  [ Merc-c. ]). The response of this bioassay to homeopathic treatments as a function of stress intensity was also of interest.
METHODS


Duckweed was severely stressed with mercury(II) chloride for 48 hours. Afterwards plants grew in either  Merc-c.  (seven different potency levels, 24x to 30x) or water controls (unsuccussed and succussed water) for 7 days. Growth rates of the frond (leaf) area were determined using a computerised image analysis system for different time intervals between the measurements on days 0, 3 and 7. Three independent experiments with potentised  Merc-c.  each were evaluated. Additionally, three water control experiments were analysed to investigate the stability of the experimental set-up (systematic negative control [SNC] experiments). All experiments were randomised and blinded.
RESULTS


Unsuccussed and succussed water did not significantly differ in terms of duckweed growth rate. The SNC experiments did not yield any significant effects, providing evidence for the stability of the experimental system. Data from the two control groups and the seven treatment groups ( Merc-c.  24x-30x) were each pooled to increase the statistical power. Duckweed growth rates for day 0 to 3 were reduced ( p  < 0.05) after application of  Merc-c.  compared with the controls. Growth rates for day 3 to 7 were not influenced by the homeopathic preparations.
CONCLUSIONS


The present test system with  Lemna gibba  L. that was severely stressed by mercury yielded evidence for specific effects of  Merc-c.  24x to 30x, namely a growth reduction in the first time period (day 0-3). This is in contrast to former experiments with slightly arsenic-stressed duckweed, where a growth increase was observed in the second time period (day 2-6). We hypothesise that the differing results are associated with the level of stress intensity (severe versus slight).",2019,Duckweed growth rates for day 0 to 3 were reduced ( p  < 0.05) after application of  Merc-c.  compared with the controls.,['Severely Mercury-Stressed Duckweed Lemna gibba L'],['homeopathically potentised mercury(II) chloride'],"['duckweed growth rate', 'Growth rates', 'Growth rates of the frond (leaf) area', 'Duckweed growth rates']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025424', 'cui_str': 'Mercury'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0025423', 'cui_str': 'calomel'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0320641,Duckweed growth rates for day 0 to 3 were reduced ( p  < 0.05) after application of  Merc-c.  compared with the controls.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Jäger', 'Affiliation': 'Institute of Integrative Medicine, University of Witten/Herdecke, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Würtenberger', 'Affiliation': 'Scientific and Regulatory Affairs, Hevert-Arzneimittel GmbH & Co. KG, Nussbaum, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baumgartner', 'Affiliation': 'Institute of Integrative Medicine, University of Witten/Herdecke, Germany.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0038-1676464']
1264,30843038,QT as a predictor of recurrence after atrial fibrillation ablation and the impact of amiodarone: results from the placebo-controlled AMIO-CAT trial.,"AIMS


Prolonged corrected QT interval (QTc) might be associated with arrhythmia recurrence after atrial fibrillation (AF) ablation. The effect of short-term amiodarone in this setting remains unknown. This study seeks to quantify short-term amiodarone's impact on QTc, and to investigate QTc and amiodarone treatment as predictors of recurrence of arrhythmia after ablation.
METHODS AND RESULTS


The Short-term AMIOdarone treatment after CATheter ablation for atrial fibrillation (AMIO-CAT) trial randomized patients to 8 weeks of oral amiodarone or placebo following AF ablation. Scheduled and symptom-driven 12-lead electrocardiography and 3-day Holter-monitorings were performed. The endpoint was atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting >30 s. The cut-off for prolonged QTc was 450 ms for men and 460 ms for women. A total of 212 patients were included, of which 108 were randomized to amiodarone and 104 to placebo. From baseline to 1 month QTc in the amiodarone group increased by 27 (±30) ms, while at 6 months QTc had normalized. After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023]. Among patients with baseline QTc below median, amiodarone treatment decreased the rate of AF/AT recurrences (HR 0.43, P = 0.008).
CONCLUSIONS


Amiodarone increased QTc with 27 ms compared to placebo, and this effect decreased rapidly after drug discontinuation. Prolonged QTc at baseline independently predicted AF/AT recurrence, and baseline QTc identified patients who would possibly benefit from short-term amiodarone following ablation.",2019,"After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023].","['following AF ablation', 'A total of 212 patients']","['Amiodarone', 'placebo', 'amiodarone or placebo', 'amiodarone', 'AMIOdarone', 'QT', 'AIMS\n\n\nProlonged corrected QT interval (QTc']","['atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting ', 'rate of AF/AT recurrences', 'QTc', 'new AF/AT recurrence', 'Prolonged QTc']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",212.0,0.144308,"After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023].","[{'ForeName': 'Søren Zöga', 'Initials': 'SZ', 'LastName': 'Diederichsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Darkner', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz028']
1265,30833068,"Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial.","BACKGROUND


Hepatitis D is the most severe form of chronic viral hepatitis. Treatment guidelines recommend 1 year of peginterferon alfa, which is effective in 25-30% of patients only. Whether prolonged therapy with peginterferon alfa-2a for 96 weeks and combination therapy with tenofovir disoproxil fumarate (TDF) would increase hepatitis D virus (HDV) RNA suppression is unknown. We aimed to explore whether prolonged treatment of HDV with 96 weeks of peginterferon would increase HDV RNA response rates and reduces post-treatment relapses.
METHODS


We did two parallel, investigator-initiated, multicentre, double-blind randomised, controlled trials at 14 study sites in Germany, Greece, Romania, and Turkey. Patients with chronic HDV infection and compensated liver disease who were aged 18 years or older were eligible for inclusion. All patients were HBsAg positive for at least 7 months, anti-HDV positive for at least 3 months, and HDV-RNA positive at the local laboratory at the screening visit. Patients were ineligible if alanine aminotransferase levels were higher than ten times above the upper limit of normal and if platelet counts were lower than 90 000 per μL, or if they had received interferon therapy or treatment with a nucleoside and nucleotide analogue within the preceding 6 months. Patients were randomly assigned by blinded stratified block randomisation (1:1) to receive 180 μg of peginterferon alfa-2a weekly plus either TDF (300 mg once daily) or placebo for 96 weeks. The primary endpoint was the percentage of patients with undetectable HDV RNA at the end of treatment assessed by intention to treat. The trials are registered as NCT00932971 and NCT01088659.
FINDINGS


Between June 24, 2009, and Feb 28, 2011, we randomly assigned 59 HDV RNA-positive patients to receive peginterferon alfa-2a plus TDF and 61 to receive peginterferon alfa-2a plus placebo, including 48 (40%) patients with cirrhosis to the two treatment groups (23 in the peginterferon alfa-2a plus TDF group and 25 in the peginterferon alfa-2a plus placebo group). The primary endpoint was achieved in 28 (48%) of 59 patients in the peginterferon alfa-2a plus TDF group and in 20 (33%) of 61 patients in the peginterferon alfa-2a plus placebo group (odds ratio 1·84, 95% CI 0·86-3·91, p=0·12). We recorded 944 adverse events (459 in the peginterferon alfa-2a plus TDF group and 485 in the peginterferon alfa-2a plus placebo group). The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
INTERPRETATION


Addition of TDF resulted in no significant improvement in HDV RNA response rates at the end of treatment. These findings highlight that alternative treatment options are needed for hepatitis D.
FUNDING


The HepNet Study-House (a project of the German Liver Foundation founded by the German Liver Foundation, the German Ministry for Education and Research, and the German Center for Infectious Disease Research), Hoffmann-La Roche, and Gilead Sciences.",2019,"The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
","['Between June 24, 2009, and Feb 28, 2011, we randomly assigned 59 HDV RNA-positive patients to receive', 'Patients with chronic HDV infection and compensated liver disease who were aged 18 years or older were eligible for inclusion', 'hepatitis D (HIDIT-II']","['tenofovir disoproxil fumarate (TDF', 'peginterferon alfa-2a weekly plus either TDF', 'peginterferon alfa-2a plus placebo', 'placebo', 'peginterferon alfa-2a plus TDF', 'peginterferon alfa', 'interferon therapy or treatment with a nucleoside and nucleotide analogue', 'peginterferon alfa-2a', 'Peginterferon alfa-2a plus tenofovir disoproxil fumarate', 'peginterferon']","['haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints', 'HDV RNA response rates', 'hepatitis D virus (HDV) RNA suppression', 'percentage of patients with undetectable HDV RNA', 'alanine aminotransferase levels']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011226', 'cui_str': 'Delta Infection'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279030', 'cui_str': 'Interferon therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3884490', 'cui_str': '4-amino-3-(2-(6-cyano-2-naphthyl)ethynyl)-1-(2-deoxypentofuranosyl)-1H-pyrazolo(3,4-d)pyrimidine'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0486926', 'cui_str': 'Hepatitis D virus RNA'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",59.0,0.728827,"The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
","[{'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Wedemeyer', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany; Department of Gastroenterology and Hepatology, Essen University Hospital, Essen, Germany; Medical Faculty of the University of Duisburg-Essen, Essen, Germany. Electronic address: heiner.wedemeyer@uk-essen.de.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Yurdaydin', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey; Department of Internal Medicine, Koc University Medical School, Istanbul, Turkey.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Hardtke', 'Affiliation': 'German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': 'Florin Alexandru', 'Initials': 'FA', 'LastName': 'Caruntu', 'Affiliation': 'Institutul de Boli Infectioase, Bucharest, Romania.'}, {'ForeName': 'Manuela G', 'Initials': 'MG', 'LastName': 'Curescu', 'Affiliation': 'Spitalul Clinic de Boli Infectioase si, Timisoara, Romania.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Yalcin', 'Affiliation': 'Dicle University Medical Faculty, Diyarbakir, Turkey.'}, {'ForeName': 'Ulus S', 'Initials': 'US', 'LastName': 'Akarca', 'Affiliation': 'Ege University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Gürel', 'Affiliation': 'Uludağ University Medical Faculty, Bursa, Turkey.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zeuzem', 'Affiliation': 'Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Erhardt', 'Affiliation': 'Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüth', 'Affiliation': 'University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Papatheodoridis', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Keskin', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Port', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Radu', 'Affiliation': 'Institutul de Boli Infectioase, Bucharest, Romania.'}, {'ForeName': 'Mustafa K', 'Initials': 'MK', 'LastName': 'Celen', 'Affiliation': 'Dicle University Medical Faculty, Diyarbakir, Turkey.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Idilman', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Stift', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Wittkop', 'Affiliation': 'Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heidrich', 'Affiliation': 'German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Mederacke', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Hans Peter', 'Initials': 'HP', 'LastName': 'Dienes', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Cornberg', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30663-7']
1266,30765508,"A randomised, placebo-controlled study of omipalisib (PI3K/mTOR) in idiopathic pulmonary fibrosis.","Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR) play a role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). Omipalisib (GSK2126458) is a potent inhibitor of PI3K/mTOR.A randomised, placebo-controlled, double-blind, repeat dose escalation, experimental medicine study of omipalisib in subjects with IPF was conducted (NCT01725139) to test safety, tolerability, pharmacokinetics and pharmacodynamics. Omipalisib was dosed at 0.25 mg, 1 mg and 2 mg twice daily for 8 days in four cohorts of four subjects randomised 3:1 to receive omipalisib or placebo (two cohorts received 2 mg twice daily).17 subjects with IPF were enrolled. The most common adverse event was diarrhoea, which was reported by four participants. Dose-related increases in insulin and glucose were observed. Pharmacokinetic analysis demonstrated that exposure in the blood predicts lung exposure. Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  18 F-2 - fluoro-2-deoxy-d-glucose(FDG)-positron emission tomography/computed tomography scans revealed an exposure-dependent reduction in  18 F-FDG uptake in fibrotic areas of the lung, as measured by target-to-background, ratio thus confirming pharmacodynamic activity.This experimental medicine study demonstrates acceptable tolerability of omipalisib in subjects with IPF at exposures for which target engagement was confirmed both systemically and in the lungs.",2019,"Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  ","['idiopathic pulmonary fibrosis (IPF', 'subjects with IPF at exposures', 'subjects with IPF', 'idiopathic pulmonary fibrosis', 'daily).17 subjects with IPF were enrolled', '18']","['Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR', 'placebo', 'omipalisib or placebo', 'F-2 - fluoro-2-deoxy-d-glucose(FDG)-positron emission tomography/computed tomography scans', 'omipalisib (PI3K/mTOR', 'Omipalisib']","['safety, tolerability, pharmacokinetics and pharmacodynamics', 'insulin and glucose']","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0044602', 'cui_str': 'Phosphoinositide 3 Kinase'}, {'cui': 'C0293060', 'cui_str': 'Mammalian Target of Rapamycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0092882', 'cui_str': '2-Fluoro-2-deoxy-D-glucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.218541,"Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  ","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Lukey', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Yim', 'Initials': 'Y', 'LastName': 'Man', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Beverley F', 'Initials': 'BF', 'LastName': 'Holman', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Alaleh', 'Initials': 'A', 'LastName': 'Rashidnasab', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Azzopardi', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grayer', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Juliet K', 'Initials': 'JK', 'LastName': 'Simpson', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bareille', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Hannah V', 'Initials': 'HV', 'LastName': 'Woodcock', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Toshner', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Saunders', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Molyneaux', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Thielemans', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Wilson', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Mercer', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Chambers', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Groves', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fahy', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Marshall', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK t.maher@imperial.ac.uk.'}]",The European respiratory journal,['10.1183/13993003.01992-2018']
1267,30830724,Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia.,"AIM


Phase III, randomized, double-blind study evaluating the efficacy and safety of ertugliflozin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin, including evaluation in the China subpopulation.
MATERIALS AND METHODS


A 26-week, double-blind study of 506 Asian patients (80.2% from mainland China), randomized 1:1:1 to placebo, ertugliflozin 5- or 15 mg, was performed. Primary endpoint was change from baseline in HbA1c at week 26. Secondary endpoints were change from baseline at week 26 in fasting plasma glucose (FPG), body weight (BW), systolic/diastolic blood pressure (SBP/DBP), and proportion of patients with HbA1c <7.0%. Hypotheses for the primary endpoint and FPG and BW secondary endpoints were tested in the China subpopulation.
RESULTS


At week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo: -1.0% (-1.1, -0.9), -0.9% (-1.0, -0.8), -0.2% (-0.3, -0.1), respectively. Ertugliflozin significantly reduced FPG, BW and SBP. Reductions in DBP with ertugliflozin were not significant. At week 26, 16.2%, 38.2% and 40.8% of patients had HbA1c <7.0% with placebo, ertugliflozin 5- and 15 mg, respectively. 59.3%, 56.5% and 53.3% of patients experienced adverse events with placebo, ertugliflozin 5- and 15 mg, respectively. Incidence of symptomatic hypoglycaemia was higher for ertugliflozin 15 mg vs placebo. Results in the China subpopulation were consistent.
CONCLUSIONS


Ertugliflozin significantly improved glycaemic control and reduced BW and SBP in Asian patients with T2DM. Ertugliflozin was generally well-tolerated. Results in the China subpopulation were consistent with the overall population. ClinicalTrials.gov: NCT02630706.",2019,"At week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo: -1.0% (-1.1, -0.9),","['Asian patients with T2DM', 'Asian patients with type 2 diabetes mellitus inadequately controlled with', 'Asian patients with type 2 diabetes mellitus (T2DM', '506 Asian patients (80.2% from mainland China']","['placebo', 'Ertugliflozin', 'metformin', 'placebo, ertugliflozin', 'placebo, ertugliflozin 5- or 15\u2009mg', 'ertugliflozin', 'metformin monotherapy']","['glycaemic control and reduced BW and SBP', 'tolerated', 'adverse events', 'FPG, BW and SBP', 'Incidence of symptomatic hypoglycaemia', 'fasting plasma glucose (FPG), body weight (BW), systolic/diastolic blood pressure (SBP/DBP), and proportion of patients with HbA1c <7.0', 'efficacy and safety', 'Safety and efficacy']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",506.0,0.307856,"At week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo: -1.0% (-1.1, -0.9),","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Yancheng First People's Hospital, Yancheng, China.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Pfizer (China) R&D Co., Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Pfizer (China) R&D Co., Shanghai, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Pfizer (China) R&D Co., Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Pfizer (China) R&D Co., Shanghai, China.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Pfizer Inc., New York, New York.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Lauring', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'MSD China, Beijing, China.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'MSD China, Beijing, China.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13681']
1268,30740846,Intranasal glucagon acutely increases energy expenditure without inducing hyperglycaemia in overweight/obese adults.,"AIM


To assess the acute effects of 0.7 mg intranasal glucagon (ING) vs intranasal placebo (INP) on food intake and resting energy expenditure (REE).
METHODS


A single-blind, crossover study was conducted in 19 overweight/obese adults (15 men, 4 women). REE was assessed by indirect calorimetry over 90 minutes, after which appetite was assessed using a visual analogue scale, and ad libitum caloric intake was assessed. Plasma samples were obtained at baseline and at 15-minute intervals post-treatment up to 90 minutes.
RESULTS


ING increased total REE (INP 61.5 ± 1.2 kcal vs ING 69.4 ± 1.2 kcal; P = 0.027). There were no between-treatment differences in blood glucose, food intake and appetite. There were no adverse effects.
CONCLUSION


ING acutely increases REE without increasing plasma glucose. Longer term studies with multiple daily dosing will establish whether this affects body weight.",2019,"There were no between-treatment differences in blood glucose, food intake and appetite.","['overweight/obese adults', '19 overweight/obese adults (15 men, 4 women']","['intranasal glucagon (ING) vs intranasal placebo (INP', 'Intranasal glucagon']","['total REE', 'blood glucose, food intake and appetite', 'plasma glucose', 'food intake and resting energy expenditure (REE', 'visual analogue scale, and ad libitum caloric intake', 'adverse effects', 'Plasma samples', 'hyperglycaemia', 'REE']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",19.0,0.104554,"There were no between-treatment differences in blood glucose, food intake and appetite.","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Stahel', 'Affiliation': 'Departments of Medicine and Physiology, Banting and Best Diabetes Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'So Jeong', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Departments of Medicine and Physiology, Banting and Best Diabetes Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shawn K', 'Initials': 'SK', 'LastName': 'Sud', 'Affiliation': 'Departments of Medicine and Physiology, Banting and Best Diabetes Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Floh', 'Affiliation': 'Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Dash', 'Affiliation': 'Departments of Medicine and Physiology, Banting and Best Diabetes Centre, University of Toronto, Toronto, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13661']
1269,30802609,Laparoscopic Entry Technique Using a Veress Needle Insertion with and without Concomitant CO 2  Insufflation: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To compare the time and number of attempts needed for successful Veress needle entry during laparoscopic surgery using concomitant versus subsequent CO 2  insufflation approaches.
DESIGN


Randomized controlled trial.
SETTING


University teaching hospital.
PATIENTS


One hundred consecutive patients scheduled for laparoscopic surgery by 2 high-volume laparoscopic surgeons were screened and randomized, and 95 of these were included in the final analysis. Ninety (45 in each group) was the precalculated priori number of patients needed to detect a 50% difference in the time (seconds) to obtain adequate insufflation with 90% power and alpha of 5%.
INTERVENTIONS


Patients were randomized to either Veress needle entry with concomitant (Con) or subsequent (Sub) CO 2  insufflation.
MEASUREMENTS AND MAIN RESULTS


Forty-six patients were randomized to the Con group and 49 to the Sub group. Patient age, body mass index, prior surgical history, presence of adhesions, and type of procedure performed were similar between both groups. The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16). Approximately 89% (95% confidence interval, 80.1%-98.1%) of patients in Con group achieved successful entry in the first attempt compared with only 67% (95% confidence interval, 54.2%-80.0%) in Sub group (p = .01). The incidence of preperitoneal insufflation and failed entry was comparable between the 2 groups. No patient developed solid organ, visceral, or vascular injuries; gas embolism; or case conversion to laparotomy in relation to the Veress needle entry technique.
CONCLUSION


Veress needle entry with concomitant CO 2  insufflation was associated with a higher rate of successful entry during the first attempt of Veress needle insertion. The total time required for insufflation and rates of complications between the 2 techniques were similar.",2019,"The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16).","['Forty-six patients', 'One hundred consecutive patients scheduled for laparoscopic surgery by 2 high-volume laparoscopic surgeons were screened and randomized, and 95 of these were included in the final analysis', 'University teaching hospital']","['Laparoscopic Entry Technique Using a Veress Needle Insertion with and without Concomitant CO 2  Insufflation', 'Veress needle entry with concomitant (Con) or subsequent (Sub) CO 2  insufflation']","['solid organ, visceral, or vascular injuries; gas embolism', 'median time required for adequate insufflation', 'incidence of preperitoneal insufflation and failed entry', 'total time required for insufflation and rates of complications', 'successful entry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0440790', 'cui_str': 'Solid organ (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C0013926', 'cui_str': 'Air Embolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",100.0,0.133146,"The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16).","[{'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Mikhail', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida. Electronic address: emikhail@health.usf.edu.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Tamhane', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida.'}, {'ForeName': 'Papri', 'Initials': 'P', 'LastName': 'Sarkar', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Sappenfield', 'Affiliation': 'Department of Obstetrics and Gynecology (Dr. Sappenfield), Hartford Hospital, Hartford, Connecticut.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Tanner', 'Affiliation': 'Department of Community and Family Health (Dr. Tanner), College of Public Health, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Imudia', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.02.011']
1270,30821897,A synbiotic supplement for inflammation and oxidative stress and lipid abnormalities in hemodialysis patients.,"INTRODUCTION


Among the most important risk factors for cardiovascular disease in hemodialysis patients are high concentrations of serum inflammation markers, lipid profiles, and oxidative stress. The present study aimed to investigate the effects of a synbiotic supplement on serum systemic inflammation, oxidative stress markers, and lipid profile in hemodialysis patients.
METHODS


Fifty hemodialysis patients were randomly allocated to synbiotic and placebo groups. The synbiotic group received 2 tablets per day of a synbiotic supplement (100 mg) Lactobacillus coagulans and fructo-oligosaccharides for 8 weeks; whereas the placebo group received a similar appearing placebo. At the beginning and end of the study, 5 mL blood was taken after 12-14 hours of fasting.
FINDINGS


Mean values of serum C-reactive protein (hs-CRP) and malondialdehyde (MDA) significantly decreased in the synbiotic group at the end compared to the beginning of the study (P = 0.01). This reduction was significant in comparison with changes in the placebo group (P = 0.01). The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
DISCUSSION


The synbiotic supplement used improves serum hs-CRP and MDA, total cholesterol and LDL-c in hemodialysis patients, which are known risk factors for cardiovascular disease.",2019,"The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
","['hemodialysis patients', 'Fifty hemodialysis patients']","['synbiotic and placebo', 'placebo', 'synbiotic supplement']","['serum systemic inflammation, oxidative stress markers, and lipid profile', 'Mean values of serum C-reactive protein (hs-CRP) and malondialdehyde (MDA', 'inflammation and oxidative stress and lipid abnormalities', 'Lactobacillus coagulans and fructo-oligosaccharides', 'low-density lipoprotein cholesterol', 'serum inflammation markers, lipid profiles, and oxidative stress', 'serum total cholesterol', 'serum hs-CRP and MDA, total cholesterol and LDL-c']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",50.0,0.104253,"The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Traditional and Complementary Medicine Center, Department of Nutrition & Biochemistry, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Tofighiyan', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Miri', 'Affiliation': 'Cellular and Molecular Research Center, Department of Environmental Health Engineering, School of Public Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12748']
1271,30578395,Fibroblast growth factor 21 predicts outcome in community-acquired pneumonia: secondary analysis of two randomised controlled trials.,"Acute systemic inflammatory conditions are accompanied by profound alterations of metabolism. However, the role of fibroblast growth factor 21 (FGF21), a recently identified central regulator of metabolism, is largely unknown in community-acquired pneumonia (CAP). This study aims to characterise the pattern of FGF21 in pneumonia and associations with disease severity and outcome.This is a secondary analysis of two independent multicentre randomised controlled trials in patients presenting to the emergency department with CAP. Primary and secondary efficacy parameters included 30-day mortality, length of hospital stay, time to clinical stability and duration of antibiotic treatment.A total of 509 patients were included in the analysis. FGF21 levels at admission strongly correlated with disease severity, as measured by the Pneumonia Severity Index. Increased levels of FGF21 were associated with prolonged time to clinical stability, antibiotic treatment and hospitalisation. FGF21 levels at admission were significantly higher in nonsurvivors than in survivors, yielding a 1.61-fold increased adjusted odds ratio of 30-day mortality (95% CI 1.21-2.14; p=0.001). Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.Moderate-to-severe CAP patients with higher levels of FGF21 were at increased risk for clinical instability, prolonged hospitalisation and 30-day all-cause mortality.",2019,"Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.","['patients presenting to the emergency department with CAP', 'community-acquired pneumonia', 'A total of 509 patients were included in the analysis']","['Fibroblast growth factor 21', 'FGF21']","['Pneumonia Severity Index', 'FGF21 levels at admission', 'Increased levels of FGF21', '30-day mortality', 'clinical stability, antibiotic treatment and hospitalisation', 'FGF21 levels', '30-day mortality, length of hospital stay, time to clinical stability and duration of antibiotic treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}]","[{'cui': 'C1321595', 'cui_str': 'Pneumonia severity of illness index'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",509.0,0.147542,"Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.","[{'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Wolffenbuttel', 'Affiliation': 'Dept of Internal Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Claudine A', 'Initials': 'CA', 'LastName': 'Blum', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Dept of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'University Dept of Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'University Dept of Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meier', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Kraenzlin', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias Johannes', 'Initials': 'MJ', 'LastName': 'Betz', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",The European respiratory journal,['10.1183/13993003.00973-2018']
1272,30599145,Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia.,"INTRODUCTION


During vocalization, efference copy/corollary discharge mechanisms suppress the auditory cortical response to self-generated sounds as reflected in the N1 component of the auditory event-related potential (ERP). N1 suppression during talking is reduced in patients with schizophrenia. We hypothesized that these deficits would recover with auditory training that targets the speech processing system.
METHODS


Forty-nine individuals early in the course of a schizophrenia-spectrum illness (ESZ) were randomly assigned to 40 h of Targeted Auditory Training (TAT; n = 23) or Computer Games (CG; n = 26). The N1 ERP component was elicited during production (Talk) and playback (Listen) of vocalization. Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed. Simple effects of the passage of time were also assessed in the HC after 28 weeks.
RESULTS


There was a Treatment × Time interaction revealing that N1 suppression was improved with TAT, but not with CG. TAT, but not CG, also improved Global Cognition. However, TAT and CG groups differed in their pre-treatment N1 suppression, and greater N1-suppression abnormalities were strongly associated with greater improvement in N1 suppression.
CONCLUSIONS


In this sample of ESZ individuals, targeted auditory training appeared to improve the function of the efference copy/corollary discharge mechanism which tended to deteriorate with computer games. It remains to be determined if baseline N1 suppression abnormalities are necessary for TAT treatment to have a positive effect on efference copy/corollary discharge function or if improvements observed in this study represent a regression to the mean N1 suppression in ESZ.
TRIAL REGISTRATION


ClinicalTrials.govNCT00694889. Registered 1 August 2007.",2019,"Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed.","['Forty-nine individuals early in the course of a schizophrenia-spectrum illness (ESZ', 'patients with schizophrenia']","['Targeted Auditory Training (TAT; n\u202f=\u202f23) or Computer Games (CG', 'cognitive training', 'auditory training', 'TAT']","['N1-suppression abnormalities', 'N1 suppression', 'Efference copy/corollary discharge function', 'Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening', 'Global Cognition']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",,0.0568286,"Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed.","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'San Francisco VA Healthcare System, United States of America. Electronic address: brian.roach@ncire.org.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': 'University of California at San Francisco, United States of America; San Francisco VA Healthcare System, United States of America. Electronic address: Judith.ford@ucsf.edu.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Biagianti', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: bruno.biagianti@positscience.com.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Hamilton', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: holly.hamilton@ucsf.edu.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: ramsa045@umn.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: mafisher@umn.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: rachel.loewy@ucsf.edu.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: svinogra@umn.edu.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California at San Francisco, United States of America; San Francisco VA Healthcare System, United States of America. Electronic address: daniel.mathalon@ucsf.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2018.12.015']
1273,31493887,Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization.,"BACKGROUND


Peanut sublingual immunotherapy (SLIT) for 1 year has been shown to induce modest clinical desensitization in allergic children. Studies of oral immunotherapy, epicutaneous immunotherapy, and SLIT have suggested additional benefit with extended treatment.
OBJECTIVE


We sought to investigate the safety, clinical effectiveness, and immunologic changes with long-term SLIT in children with peanut allergy.
METHODS


Children with peanut allergy aged 1 to 11 years underwent extended maintenance SLIT with 2 mg/d peanut protein for up to 5 years. Subjects with peanut skin test wheals of less than 5 mm and peanut-specific IgE levels of less than 15 kU/L were allowed to discontinue therapy early. Desensitization was assessed through a double-blind, placebo-controlled food challenge (DBPCFC) with up to 5000 mg of peanut protein after completion of SLIT dosing. Sustained unresponsiveness was further assessed by using identical DBPCFCs after 2 to 4 weeks without peanut exposure.
RESULTS


Thirty-seven of 48 subjects completed 3 to 5 years of peanut SLIT, with 67% (32/48) successfully consuming 750 mg or more during DBPCFCs. Furthermore, 25% (12/48) passed the 5000-mg DBPCFC without clinical symptoms, with 10 of these 12 demonstrating sustained unresponsiveness after 2 to 4 weeks. Side effects were reported with 4.8% of doses, with transient oropharyngeal itching reported most commonly. Side effects requiring antihistamine treatment were uncommon (0.21%), and no epinephrine was administered. Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
CONCLUSION


Extended-therapy peanut SLIT provided clinically meaningful desensitization in the majority of children with peanut allergy that was balanced with ease of administration and a favorable safety profile.",2019,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","['Children with peanut allergy aged 1 to 11\xa0years underwent', 'children', 'allergic children', 'children with peanut allergy', 'Thirty-seven of 48 subjects completed 3 to 5\xa0years of peanut SLIT, with 67% (32/48) successfully consuming 750\xa0mg or more during DBPCFCs']","['oral immunotherapy, epicutaneous immunotherapy, and SLIT', 'placebo-controlled food challenge (DBPCFC', 'sublingual immunotherapy', 'epinephrine', 'Peanut sublingual immunotherapy (SLIT', 'extended maintenance SLIT with 2\xa0mg/d peanut protein', 'antihistamine']","['Peanut skin test wheals, peanut-specific IgE levels, and basophil activation', 'Side effects', 'peanut-specific IgG 4  levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",48.0,0.108432,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Luanna', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Rishu', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kulis', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.030']
1274,30819527,Re: Bladder Preservation with Twice-a-day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine for Muscle-invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,,2019,,['Muscle-invasive Bladder Cancer'],['Re: Bladder Preservation with Twice-a-day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0405648,,"[{'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: fred.witjes@radboudumc.nl.'}]",European urology,['10.1016/j.eururo.2019.02.020']
1275,31419544,Crisaborole and atopic dermatitis skin biomarkers: An intrapatient randomized trial.,"BACKGROUND


Crisaborole ointment 2% is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). The mechanism of action of crisaborole and its effects on lesional measures of disease severity are not yet well defined.
OBJECTIVE


This phase 2a, single-center, vehicle-controlled, intrapatient study was designed to further characterize the mechanism of action of crisaborole through evaluation of clinical efficacy and changes in skin biomarkers in adults (n = 40) with mild-to-moderate AD.
METHODS


Two target lesions were randomized in an intrapatient (1:1) manner to double-blind crisaborole/vehicle applied twice daily for 14 days. Patients then applied crisaborole (open-label) to all affected areas for 28 days. Punch biopsy specimens were collected for biomarker analysis at baseline, day 8 (optional), and day 15.
RESULTS


Crisaborole treatment resulted in early improvement in lesional signs/symptoms versus vehicle, with improvement in pruritus (pruritus numeric rating scale) observed as early as 24 hours after the first application. Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptomic profile compared with vehicle at day 8 (91.15% vs 36.02%, P < 10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P < 10 -15 ). Crisaborole significantly modulated key AD biomarkers versus vehicle, including T H 2 and T H 17/T H 22 pathways and epidermal hyperplasia/proliferation. Molecular profiles and epidermal pathology normalized toward nonlesional skin and correlated with clinical changes in lesion severity and barrier function.
CONCLUSION


Crisaborole reversed biomarker profiles of skin inflammation and barrier function, with associated improvements in clinical efficacy measures, highlighting the therapeutic utility of targeting phosphodiesterase 4 in patients with AD.",2019,"Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptome profile compared with vehicle at day 8 (91.15% vs 36.02%, P<10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P<10 -15 ).","['Crisaborole and atopic dermatitis skin biomarkers', 'adults (N = 40) with mild-to-moderate AD', 'mild-to-moderate atopic dermatitis (AD', 'Two target lesions']",[],"['skin inflammation and barrier function', 'pruritus (pruritus numeric rating scale', 'type 2 helper T-cell (Th2) and Th17/Th22 pathways and epidermal hyperplasia/proliferation', 'lesion signs/symptoms', 'lesional transcriptome profile']","[{'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}]",[],"[{'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0242633', 'cui_str': 'T Helper2 Cells'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}]",,0.0724075,"Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptome profile compared with vehicle at day 8 (91.15% vs 36.02%, P<10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P<10 -15 ).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Aisleen', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY; Ponce Health Sciences University School of Medicine, Ponce, Puerto Rico.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Werth', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Chuanbo', 'Initials': 'C', 'LastName': 'Zang', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Vranic', 'Affiliation': 'Pfizer, Surrey, United Kingdom.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Pfizer, Groton, Conn.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Zielinski', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Vlahos', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Saint-Cyr Proulx', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer, Groton, Conn.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Emma.Guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.047']
1276,30815995,Microwave ablation vs. parathyroidectomy for secondary hyperparathyroidism in maintenance hemodialysis patients.,"INTRODUCTION


Secondary hyperparathyroidism (SHPT) is a serious and common problem in patients undergoing maintenance hemodialysis. Minimally invasive microwave ablation (MWA) has been used to treat SHPT and shows some advantages. However, its efficacy is still undefined. The primary purpose of this study was to determine the efficacy and safety of MWA compared to total parathyroidectomy plus forearm autotransplantation.
METHODS


The SHPT patients who were undergoing maintenance hemodialysis (follow-up for 6 to 24 months after treatments) were divided into a MWA group (n = 33) and a parathyroidectomy group (n = 48). The efficacy (serum intact parathyroid hormone [iPTH], calcium, and phosphorus levels) and safety (hoarseness, hypocalcaemia, and persistently low iPTH) were compared between the two groups. Additionally, the study explored potential predictors of response to MWA by a logistic regression analysis.
FINDINGS


There were no significant differences in baseline characteristics between the two groups. The rates of achieving the recommended goal for iPTH were significantly higher in the MWA group than that in the parathyroidectomy group at all follow-up times: 57.58% vs. 12.50% at one-day (P < 0.001), 45.45% vs. 16.67% at 1-week (P = 0.005), 57.58% vs. 16.67% at 2-week (P < 0.001), 57.58% vs. 22.92% at 1-month (P = 0.002), and 69.70% vs. 35.42% at 3-month (P = 0.002), 76.47% vs. 28.57% at 6-month (P = 0.005), 87.50% vs. 47.37% at 12-month (P = 0.008), and 81.82% vs. 52.63% at 24-month (P = 0.015), respectively. However, there were no significant differences for phosphorus or calcium at any of the follow-up times (P > 0.05). The persistently low iPTH was more in the parathyroidectomy group (64.6%) than that in the MWA group (0%) (P < 0.001), but there was no significant difference in hoarseness or hypocalcaemia (P > 0.05). Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
CONCLUSION


The MWA could be an alternative to parathyroidectomy for SHPT but its eventual superiority has to be demonstrated by a proper study.",2019,"Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
","['maintenance hemodialysis patients', 'The SHPT patients who were undergoing maintenance hemodialysis (follow-up for 6 to 24\u2009months after treatments', 'patients undergoing maintenance hemodialysis']","['total parathyroidectomy plus forearm autotransplantation', 'parathyroidectomy', 'Microwave ablation vs. parathyroidectomy', 'Minimally invasive microwave ablation (MWA', 'MWA']","['phosphorus or calcium', 'hoarseness or hypocalcaemia', 'efficacy and safety', 'efficacy (serum intact parathyroid hormone [iPTH], calcium, and phosphorus levels) and safety (hoarseness, hypocalcaemia, and persistently low iPTH', 'Baseline levels of iPTH', 'rates of achieving the recommended goal for iPTH']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0193696', 'cui_str': 'Complete parathyroidectomy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0218008,"Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
","[{'ForeName': 'Binghu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Ultrasonography, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Leijuan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Ultrasonography, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12740']
1277,30415629,Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease.,"BACKGROUND


It is unclear whether supplementation with vitamin D reduces the risk of cancer or cardiovascular disease, and data from randomized trials are limited.
METHODS


We conducted a nationwide, randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D 3  (cholecalciferol) at a dose of 2000 IU per day and marine n-3 (also called omega-3) fatty acids at a dose of 1 g per day for the prevention of cancer and cardiovascular disease among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were invasive cancer of any type and major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes). Secondary end points included site-specific cancers, death from cancer, and additional cardiovascular events. This article reports the results of the comparison of vitamin D with placebo.
RESULTS


A total of 25,871 participants, including 5106 black participants, underwent randomization. Supplementation with vitamin D was not associated with a lower risk of either of the primary end points. During a median follow-up of 5.3 years, cancer was diagnosed in 1617 participants (793 in the vitamin D group and 824 in the placebo group; hazard ratio, 0.96; 95% confidence interval [CI], 0.88 to 1.06; P=0.47). A major cardiovascular event occurred in 805 participants (396 in the vitamin D group and 409 in the placebo group; hazard ratio, 0.97; 95% CI, 0.85 to 1.12; P=0.69). In the analyses of secondary end points, the hazard ratios were as follows: for death from cancer (341 deaths), 0.83 (95% CI, 0.67 to 1.02); for breast cancer, 1.02 (95% CI, 0.79 to 1.31); for prostate cancer, 0.88 (95% CI, 0.72 to 1.07); for colorectal cancer, 1.09 (95% CI, 0.73 to 1.62); for the expanded composite end point of major cardiovascular events plus coronary revascularization, 0.96 (95% CI, 0.86 to 1.08); for myocardial infarction, 0.96 (95% CI, 0.78 to 1.19); for stroke, 0.95 (95% CI, 0.76 to 1.20); and for death from cardiovascular causes, 1.11 (95% CI, 0.88 to 1.40). In the analysis of death from any cause (978 deaths), the hazard ratio was 0.99 (95% CI, 0.87 to 1.12). No excess risks of hypercalcemia or other adverse events were identified.
CONCLUSIONS


Supplementation with vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).",2019,"A major cardiovascular event occurred in 805 participants (396 in the vitamin D group and 409 in the placebo group; hazard ratio, 0.97; 95% CI, 0.85 to 1.12; P=0.69).","['A total of 25,871 participants, including 5106 black participants, underwent randomization', 'men 50 years of age or older and women 55 years of age or older in the United States']","['vitamin D', 'vitamin D with placebo', 'placebo', 'Vitamin D Supplements', 'vitamin D 3  (cholecalciferol', 'marine n-3 (also called omega-3) fatty acids']","['site-specific cancers, death from cancer, and additional cardiovascular events', 'hazard ratio', 'hazard ratios', 'myocardial infarction', 'invasive cancer of any type and major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes', 'invasive cancer or cardiovascular events']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",25871.0,0.738218,"A major cardiovascular event occurred in 805 participants (396 in the vitamin D group and 409 in the placebo group; hazard ratio, 0.97; 95% CI, 0.85 to 1.12; P=0.69).","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Christen', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Gibson', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Copeland', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': ""D'Agostino"", 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ridge', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (J.E.M., N.R.C., I.-M.L., W.C., S.S.B., S.M., H.G., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health - all in Boston.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1809944']
1278,30776296,Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial.,"STUDY QUESTION


Does administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) in the first trimester improve pregnancy outcomes, among women with a history of unexplained recurrent pregnancy loss?
SUMMARY ANSWER


rhG-CSF administered in the first trimester of pregnancy did not improve outcomes among women with a history of unexplained recurrent pregnancy loss.
WHAT IS KNOWN ALREADY


The only previous randomized controlled study of granulocyte colony stimulating factor in recurrent miscarriage in 68 women with unexplained primary recurrent miscarriage found a statistically significant reduction in miscarriage and improvement in live birth rates. A further four observational studies where G-CSF was used in a recurrent miscarriage population were identified in the literature, two of which confirmed statistically significant increase in clinical pregnancy and live birth rates.
STUDY DESIGN, SIZE, DURATION


A randomized, double-blind, placebo controlled clinical trial involving 150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016. The study was coordinated by University of Birmingham, UK.
PARTICIPANTS/MATERIALS, SETTING, METHODS


One hundred and fifty women with a history of unexplained recurrent pregnancy loss: 76 were randomized to rhG-CSF and 74 to placebo. Daily subcutaneous injections of recombinant human granulocyte - colony stimulating factor 130 μg or identical appearing placebo from as early as three to five weeks of gestation for a maximum of 9 weeks. The trial used central randomization with allocation concealment. The primary outcome was clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan. Secondary outcomes included miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation. Analysis was by intention to treat.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 340 participants were screened for eligibility of which 150 women were randomized. 76 women (median age, 32[IQR, 29-34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26-33] years; mean BMI, 25.8[SD, 4.2]) were randomized to placebo. All women were followed-up to primary outcome, and beyond to live birth. The clinical pregnancy rate at 20 weeks, as well as the live birth rate, was 59.2% (45/76) in the rhG-CSF group, and 64.9% (48/74) in the placebo group, giving a relative risk of 0.9 (95% CI: 0.7-1.2; P = 0.48). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group. Neonatal congenital anomalies were observed in 1/46 (2.1%) of babies in the rhG-CSF group versus 1/49 (2.0%) in the placebo group (RR of 0.9; 95% CI: 0.1-13.4; P = 0.93).
LIMITATIONS, REASONS FOR CAUTION


This trial was conducted in women diagnosed with unexplained recurrent pregnancy loss and therefore no screening tests (commercially available) were performed for immune dysfunction related pregnancy failure/s.
WIDER IMPLICATIONS OF THE FINDINGS


To our knowledge, this is the first multicentre study and largest randomized clinical trial to investigate the efficacy and safety of granulocyte human colony stimulating factor in women with recurrent miscarriages. Unlike the only available single center RCT, our trial showed no significant increase in clinical pregnancy or live births with the use of rhG-CSF in the first trimester of pregnancy.
STUDY FUNDING/COMPETING INTEREST(S)


This study was sponsored and supported by Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301, USA. Darryl Carter was the co-founder and VP of research, Nora Therapeutics, Inc. and held shares in the company. He holds a patent for the use of recombinant human granulocyte colony stimulating factor to reduce unexplained recurrent pregnancy loss. Mark Joing, Paul Kwon and Jeff Tong were or are employees of Nora Therapeutics, Inc. No other potential conflict of interest relevant to this article was reported.
TRIAL REGISTRATION NUMBER


EUDRACT No: 2014-000084-40; ClinicalTrials.gov Identifier: NCT02156063.
TRIAL REGISTRATION DATE


31 Mar 2014.
DATE OF FIRST PATIENT’S ENROLMENT


23 Jun 2014.",2019,Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group.,"['women diagnosed with unexplained recurrent pregnancy loss and therefore no screening tests (commercially available) were performed for immune dysfunction related pregnancy failure/s', '76 women (median age, 32[IQR, 29-34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26-33] years; mean BMI, 25.8[SD, 4.2', 'women with a history of unexplained recurrent pregnancy loss', 'women with recurrent miscarriages', 'women with unexplained recurrent pregnancy losses', 'One hundred and fifty women with a history of unexplained recurrent pregnancy loss', '’S ENROLMENT\n\n\n23 Jun 2014', '68 women with unexplained primary recurrent miscarriage', '340 participants were screened for eligibility of which 150 women were randomized', '150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016']","['recombinant human granulocyte - colony stimulating factor 130 μg or identical appearing placebo', 'granulocyte human colony stimulating factor', 'placebo', 'rhG-CSF', 'recombinant human granulocyte colony stimulating factor (rhG-CSF', 'recombinant human granulocyte colony stimulating factor', 'granulocyte colony stimulating factor', 'Recombinant human granulocyte- colony stimulating factor']","['miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation', 'clinical pregnancy or live births', 'clinical pregnancy and live birth rates', 'live birth rate', 'clinical pregnancy rate', 'Neonatal congenital anomalies', 'Adverse events (AEs', 'miscarriage and improvement in live birth rates', 'clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0419373', 'cui_str': 'Livebirth (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]",150.0,0.578157,Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eapen', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Joing', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kwon', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maneta', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De Santo', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mussai', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lissauer', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carter', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey393']
1279,31672146,"Short-term treatment with high dose liraglutide improves lipid and lipoprotein profile and changes hormonal mediators of lipid metabolism in obese patients with no overt type 2 diabetes mellitus: a randomized, placebo-controlled, cross-over, double-blind clinical trial.","OBJECTIVE


Long-term treatment with up to 1.8 mg liraglutide improves cardiovascular and all-cause mortality in patients with type 2 diabetes at high risk for cardiovascular disease (CVD) and is currently under investigation in subjects without diabetes. Aim of our study was to investigate whether high dose (3 mg) short-term (5 weeks) treatment with liraglutide in obese patients with no overt type 2 diabetes affects metabolites, lipid and lipoprotein profile and components of activin-follistatin axis in cardiovascular beneficial or detrimental way.
RESEARCH DESIGN AND METHODS


Twenty obese patients participated in a randomized, placebo-controlled, cross-over, double-blind study and were administrated liraglutide 3 mg or placebo for 5 weeks. Metabolites, fatty acids, lipid-lipoprotein profile and concentrations of activins and follistatins (250 parameters) were assessed in serum at start and completion of each treatment.
RESULTS


Concentrations of important cardiovascular markers such as total, free and remnant cholesterol were reduced with liraglutide before and after adjusting for weight loss. Similarly, reductions in number of small and medium size LDL particles and in their total lipid concentration were observed with liraglutide and partially weight-loss related. Tyrosine levels were reduced and behenic acid levels were increased whereas only minor changes were observed in HDL, VLDL and IDL. Concentrations of activin AB and follistatin were significantly reduced in liraglutide-treated group.
CONCLUSIONS


Treatment of obese patients without overt type 2 diabetes with high dose of liraglutide for a short period of time induces changes in lipid-lipoprotein and hormonal profile that are suggestive of lower risk of atherosclerosis and CVD. Trial registration ClinicalTrials.gov Identifier: NCT02944500. Study ID Number 2015P000327. Registered November 2016.",2019,"Tyrosine levels were reduced and behenic acid levels were increased whereas only minor changes were observed in HDL, VLDL and IDL.","['patients with type 2 diabetes at high risk for cardiovascular disease (CVD', 'obese patients with no overt type 2 diabetes', 'Twenty obese patients participated in a randomized', 'obese patients with no overt type 2 diabetes mellitus', 'obese patients without overt type 2 diabetes']","['placebo', 'liraglutide', 'liraglutide 3\xa0mg or placebo']","['Concentrations of activin AB and follistatin', 'Concentrations of important cardiovascular markers such as total, free and remnant cholesterol', 'total lipid concentration', 'number of small and medium size LDL particles', 'HDL, VLDL and IDL', 'lipid and lipoprotein profile and changes hormonal mediators of lipid metabolism', 'Metabolites, fatty acids, lipid-lipoprotein profile and concentrations of activins and follistatins (250 parameters', 'Tyrosine levels', 'lipid-lipoprotein and hormonal profile', 'behenic acid levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1531699', 'cui_str': 'Activin AB'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0050668', 'cui_str': 'FSH-Releasing Protein'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0053073', 'cui_str': 'behenic acid'}]",20.0,0.381404,"Tyrosine levels were reduced and behenic acid levels were increased whereas only minor changes were observed in HDL, VLDL and IDL.","[{'ForeName': 'Natia', 'Initials': 'N', 'LastName': 'Peradze', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, SL419, Boston, MA, 02215, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, SL419, Boston, MA, 02215, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, SL419, Boston, MA, 02215, USA.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Lázaro', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Sala-Vila', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, SL419, Boston, MA, 02215, USA. cmantzor@bidmc.harvard.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0945-7']
1280,30799142,Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial.,"BACKGROUND


Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme.
METHODS


We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095).
FINDINGS


On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted β [aβ] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aβ 0·48, 95% CI -1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
INTERPRETATION


Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis's efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally.
FUNDING


Sandoz International (a subsidiary of Novartis International).",2019,"The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
","['eight counties in Kenya', '69 intervention and 58 control health facilities, and 306 intervention and 265 control patients', 'Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer', 'Counties (clusters', 'Kenya']","['control group with a covariate-constrained randomisation procedure that maximised balance', 'amlodipine', 'Novartis Access', 'metformin']","['availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households', 'availability and price of non-communicable disease medicines']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}]",,0.189302,"The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Rockers', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: prockers@bu.edu.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Laing', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA; School of Public Health, Faculty of Community and Health Sciences, University of Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Ashigbie', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Onyango', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Carol K', 'Initials': 'CK', 'LastName': 'Mukiira', 'Affiliation': 'Department of Demography and Population Studies, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Veronika J', 'Initials': 'VJ', 'LastName': 'Wirtz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30563-1']
1281,30720640,Effects of Water-Based Aerobic Interval Training in Patients With COPD: A RANDOMIZED CONTROLLED TRIAL.,"PURPOSE


Chronic obstructive pulmonary disease promotes systemic repercussions, which can be minimized with physical exercise. This study investigated the effects of a water-based aerobic interval training program on the autonomic modulation of heart rate (HR), quality of life (QoL), and functional capacity (FC) of patients with chronic obstructive pulmonary disease.
METHODS


Nineteen patients with chronic obstructive pulmonary disease were enrolled in this randomized clinical trial and allocated to either the usual care group (n = 9) or training group (n = 10). Before and after 24 sessions of water-based physical training, the patients underwent evaluation of autonomic modulation of HR by analyzing the HR variability, QoL using the St George's Respiratory Questionnaire, and FC using 6-min walk test distance.
RESULTS


The results showed significant improvement when comparing the variables of HR variability, QoL, and FC in the training group in the pre- and post-training conditions (P < .05). In the usual care group, there was no significant difference for any of the variables. Negative correlations were found between HR variability and QoL (r =-0. 55; P = .01) and 6-min walk test distance and QoL (r =-0.49; P = .02).
CONCLUSION


Water-based physical training promoted beneficial adaptations in the autonomic modulation of HR, QoL, and FC of patients with chronic obstructive pulmonary disease.",2019,"In the usual care group, there was no significant difference for any of the variables.","['patients with chronic obstructive pulmonary disease', 'Patients With COPD', 'Nineteen patients with chronic obstructive pulmonary disease']","['usual care group (n = 9) or training group', 'Water-Based Aerobic Interval Training', 'water-based aerobic interval training program', 'Water-based physical training', 'water-based physical training']","['autonomic modulation of heart rate (HR), quality of life (QoL), and functional capacity (FC', 'autonomic modulation of HR, QoL, and FC', 'HR variability, QoL, and FC', 'HR variability and QoL', '6-min walk test distance and QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034380'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",19.0,0.0375943,"In the usual care group, there was no significant difference for any of the variables.","[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Gallo-Silva', 'Affiliation': 'Laboratory of Evaluation and Intervention in Cardiorespiratory Physical Therapy of the Postgraduate Program in Physical Therapy, College of Health Sciences, Methodist University of Piracicaba, São Paulo, Brazil (Mss Gallo-Silva and Cerezer-Silva); Regional Specialty Outpatient Clinic of Limeira, Limeira, Brazil (Dr Ferreira); Department of Physical Therapy of the Einstein Integrated Faculties of Limeira, Limeira, Brazil (Dr Sakabe and Mss Kel-Souza, Bertholo, Brasil, and Ladeia); and Laboratory of Evaluation and Intervention in Cardiorespiratory Physical Therapy of the Postgraduate Program in Physical Therapy and Postgraduate Program in Human Movement Sciences, College of Health Sciences, Methodist University of Piracicaba, São Paulo, Brazil (Dr Moreno).'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Cerezer-Silva', 'Affiliation': ''}, {'ForeName': 'Danilo Gullo', 'Initials': 'DG', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Daniel Iwai', 'Initials': 'DI', 'LastName': 'Sakabe', 'Affiliation': ''}, {'ForeName': 'Luana Daniele', 'Initials': 'LD', 'LastName': 'Kel-Souza', 'Affiliation': ''}, {'ForeName': 'Vanessa Cristina', 'Initials': 'VC', 'LastName': 'Bertholo', 'Affiliation': ''}, {'ForeName': 'Mayara Thaysa Ferreira', 'Initials': 'MTF', 'LastName': 'Brasil', 'Affiliation': ''}, {'ForeName': 'Alessandra de Oliveira Amoroso', 'Initials': 'AOA', 'LastName': 'Ladeia', 'Affiliation': ''}, {'ForeName': 'Marlene Aparecida', 'Initials': 'MA', 'LastName': 'Moreno', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000352']
1282,30624373,"Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: A RANDOMIZED, CROSSOVER STUDY.","BACKGROUND


Although mainly described in patients with chronic obstructive pulmonary disease, pursed lip breathing (PLB) could prove useful in patients with interstitial lung disease (ILD) by improving exertional tachypnea and respiratory control. This prospective, randomized, crossover trial aimed at evaluating the impact of PLB on dyspnea and walking distance in ILD patients.
METHODS


ILD patients with total lung capacity of <80% predicted were randomized to 6-min walk tests using either PLB or usual breathing. Patients were crossed over for the second 6-min walk tests and served as their own controls. Ventilatory and metabolic variables were recorded using a portable metabolic cart and were compared at 1-min intervals.
RESULTS


Thirty-five patients were included (mean forced vital capacity of 64 ± 10% predicted). Use of PLB resulted in lower mean respiratory rates and larger tidal volumes (both P < .001), worsened dyspnea ratings (post-6-min walk test Borg score: 5.2 ± 2.6 vs 4.2 ± 2.3, P < .001), and walking distance (403 ± 102 m vs 429 ± 93 m, P < .001). Twenty-nine patients (83%) described PLB as less comfortable than usual breathing. Both groups had similar total ventilation and oxygen saturation (all P > .05), but PLB resulted in higher mean oxygen uptake (13.9 ± 3.6 vs 12.9 ± 3.2 mL/kg/min, P = .02), even when corrected for walking distance (P < .001).
CONCLUSION


In ILD patients, acute exposure to PLB did not improve exertional dyspnea, walking distance, or gas exchange, and was associated with higher metabolic demands than usual breathing. These results cast doubt on the usefulness of this technique in ILD patients and should be taken into account when tailoring pulmonary rehabilitation programs to this population.",2019,"Use of PLB resulted in lower mean respiratory rates and larger tidal volumes (both P < .001), worsened dyspnea ratings (post-6-min walk test Borg score: 5.2 ± 2.6 vs 4.2 ± 2.3, P < .001), and walking distance (403 ± 102 m vs 429 ± 93 m, P < .001).","['ILD patients with total lung capacity of <80', 'patients with interstitial lung disease (ILD) by improving exertional tachypnea and respiratory control', 'ILD patients', 'Patients With Interstitial Lung Disease', 'Thirty-five patients', 'patients with chronic obstructive pulmonary disease, pursed lip breathing (PLB']","['Pursed Lip Breathing', 'PLB', 'PLB or usual breathing']","['exertional dyspnea, walking distance, or gas exchange', 'walking distance', 'total ventilation and oxygen saturation', 'mean respiratory rates and larger tidal volumes', 'worsened dyspnea ratings', 'mean oxygen uptake', 'Exercise Capacity and Dyspnea', 'Ventilatory and metabolic variables', 'dyspnea and walking distance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing (finding)'}]","[{'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion (finding)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",35.0,0.0581625,"Use of PLB resulted in lower mean respiratory rates and larger tidal volumes (both P < .001), worsened dyspnea ratings (post-6-min walk test Borg score: 5.2 ± 2.6 vs 4.2 ± 2.3, P < .001), and walking distance (403 ± 102 m vs 429 ± 93 m, P < .001).","[{'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Parisien-La Salle', 'Affiliation': ""Département de Médecine (Drs Parisien-La Salle, Abel Rivest, Morisset, Manganas, Poirier, and Dubé) and Département de Kinésiologie (Lalande-Gauthier), Centre Hospitalier de l'Université de Montréal (CHUM) Montréal, Québec, Canada; Départment des Sciences de l'Activité Physique, Université du Quebec à Montréal (UQAM), Montréal, Québec, Canada (Mr Gosselin Boucher, Ms Lalande-Gauthier, and Dr Comtois); Département de Médecine, Service de Pneumologie, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada (Drs Morisset, Manganas, Poirier, and Dubé); and Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)-Carrefour de l'Innovation et de l'Évaluation en Santé, Montreal, Quebec, Canada (Dr Dubé).""}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Abel Rivest', 'Affiliation': ''}, {'ForeName': 'Vincent Gosselin', 'Initials': 'VG', 'LastName': 'Boucher', 'Affiliation': ''}, {'ForeName': 'Mélina', 'Initials': 'M', 'LastName': 'Lalande-Gauthier', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morisset', 'Affiliation': ''}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Manganas', 'Affiliation': ''}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Poirier', 'Affiliation': ''}, {'ForeName': 'Alain-Steve', 'Initials': 'AS', 'LastName': 'Comtois', 'Affiliation': ''}, {'ForeName': 'Bruno-Pierre', 'Initials': 'BP', 'LastName': 'Dubé', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000387']
1283,30634037,Minimally Invasive coronary surgery compared to STernotomy coronary artery bypass grafting: The MIST trial.,"RATIONALE


Minimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. However, there have been no convincing clinical trials that demonstrate improvement in post-operative quality of life for patients who undergo MICS CABG.
STUDY DESIGN


The Minimally Invasive Coronary Surgery compared to Sternotomy Coronary Artery Bypass Grafting (MIST) trial is a multi-centered, prospective randomized controlled trial that compares the quality of life and recovery in the early post-operative period between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients will be randomized either to the MICS CABG group or the sternotomy CABG group, and the target enrollment is 88 patients per group. The primary outcome is quality of life assessment performed by SF-36 questionnaire at 1 month.
CONCLUSION


The MIST trial is the first prospective study that compares the quality of life between MICS CABG and sternotomy CABG patients. The results of this trial may enhance the procedural desirability of MICS CABG by patients and provide an incentive for surgeons and institutions to increase the availability of MICS CABG in suitable patients.",2019,Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients.,"['patients who undergo MICS CABG', 'patients undergoing']","['Minimally Invasive Coronary Surgery', 'Minimally Invasive coronary surgery', 'Sternotomy Coronary Artery Bypass Grafting (MIST', 'sternotomy CABG', 'MICS CABG', 'Minimally invasive coronary surgery (MICS CABG', 'STernotomy coronary artery bypass grafting']","['length of hospital stay and earlier postoperative physical recovery', 'quality of life assessment performed by SF-36 questionnaire at 1\u202fmonth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0510232,Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients.,"[{'ForeName': 'Ming Hao', 'Initials': 'MH', 'LastName': 'Guo', 'Affiliation': 'Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'Department of Epidemiology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glineur', 'Affiliation': 'Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Fortier', 'Affiliation': 'Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Piroze M', 'Initials': 'PM', 'LastName': 'Davierwala', 'Affiliation': 'Division of cardiovascular surgery, Herzzentrum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Division of cardiac surgery, Wuhan Asian Heart Hospital, Wuhan, China.'}, {'ForeName': 'Massimo G', 'Initials': 'MG', 'LastName': 'Lemma', 'Affiliation': 'Division of cardiac surgery, Jilin Heart Hospital, Jilin, China.'}, {'ForeName': 'Yugal K', 'Initials': 'YK', 'LastName': 'Mishra', 'Affiliation': 'Division of cardiac surgery, Fortis Escorts Heart Institute, New Delhi, India.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGinn', 'Affiliation': 'Division of cardiothoracic surgery, Carolinas Medical Center, Charlotte, United States.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Ramchandani', 'Affiliation': 'Division of cardiothoracic surgery, Houston Methodist, Houston, United States.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Rabindra', 'Affiliation': 'Division of cardiothoracic surgery, Gundersen Lutheran Medical Center, La Crosse, United States.'}, {'ForeName': 'Sathyaki', 'Initials': 'S', 'LastName': 'Nambala', 'Affiliation': 'Division of cardiac surgery, Apollo Hospital, Bangalore, India.'}, {'ForeName': 'Kuan Ming', 'Initials': 'KM', 'LastName': 'Chiu', 'Affiliation': 'Division of cardiac surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Kiaii', 'Affiliation': 'Division of cardiac surgery, London Health Sciences Center, London, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address: mruel@ottawaheart.ca.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.006']
1284,30784555,"Comparison of prasugrel and clopidogrel in patients with non-cardioembolic ischaemic stroke: a phase 3, randomised, non-inferiority trial (PRASTRO-I).","BACKGROUND


The effect of prasugrel in terms of the prevention of recurrence of ischaemic stroke is unknown. We investigated the non-inferiority of prasugrel to clopidogrel for prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes in Japanese patients with non-cardioembolic stroke.
METHODS


In this phase 3 randomised, double-blind, non-inferiority trial, patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan. Eligible patients were randomly assigned (1:1) to receive prasugrel (3·75 mg/day) or clopidogrel (75 mg/day) orally for 96-104 weeks. Randomisation was stratified according to stroke subtype. The randomisation schedule was generated by an independent statistician who created a computer-generated random number sequence. Patients, investigators, and the funder were masked to treatment allocation. The primary endpoint was combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population. The safety endpoint was incidence of bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding. The safety analysis was done in the population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug. The predefined non-inferiority margin was an upper 95% CI limit for the risk ratio (RR) of 1·35. The trial was registered with the Japan Pharmaceutical Information Center (JapicCTI-111582).
FINDINGS


Patients were recruited between Sept 1, 2011, and June 12, 2015. 3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years. 3753 patients were randomly assigned to treatment and, of these patients, 1885 in the prasugrel group and 1862 in the clopidogrel group were confirmed to have taken the trial drug at least once, and six patients withdrew from the trial before administration of the trial drug. Thus, a total of 3747 patients were included in the full analysis set. 73 (4%) of 1885 patients in the prasugrel group and 69 (4%) of 1862 patients in the clopidogrel group reached the primary endpoint (RR 1·05, 95% CI 0·76-1·44). The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
INTERPRETATION


The non-inferiority of prasugrel to clopidogrel for the prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes was not confirmed in Japanese patients with non-cardioembolic stroke. No safety concerns were identified.
FUNDING


Daiichi Sankyo.",2019,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
","['patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan', 'Japanese patients with non-cardioembolic stroke', '3753 patients', 'patients with non-cardioembolic ischaemic stroke', 'population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug', 'Patients were recruited between Sept 1, 2011, and June 12, 2015', '3747 patients were included in the full analysis set', 'Eligible patients', '3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years']","['prasugrel to clopidogrel', 'prasugrel', 'prasugrel and clopidogrel', 'clopidogrel']","['life-threatening bleeding', 'incidence of bleeding events', 'combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population', 'bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding', 'ischaemic stroke, myocardial infarction, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3747.0,0.475259,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan. Electronic address: aogawa@iwate-med.ac.jp.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Neurology, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Tanahashi', 'Affiliation': 'Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nagata', 'Affiliation': 'Department of Neurosurgery, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30449-6']
1285,30799495,Development of a tablet app designed to improve African Americans' screening colonoscopy rates.,"Compared with other racial/ethnic groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. It is critical to help improve African Americans' CRC prevention efforts in order to reduce the burden of CRC in this community. The aim of this study was to develop and field test a tablet app, called e-Motivate, designed to improve African Americans' screening colonoscopy rates. The e-Motivate app was field tested, using an iterative approach. The first version of the app, e-Motivate 1.0, was field tested on 20 African Americans over the age of 50. Participants engaged in a think aloud exercise and provided feedback regarding the app's usability and acceptability. The results of the first field test were used to modify the app and develop e-Motivate 2.0. The field test procedures were repeated on a new group of participants (N = 18). The results from the second field test were used to make final modifications to the app. Overall, participants responded positively to the app. Qualitative analyses showed that participants found the app to be easy to use and helpful. Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability. Critiques of the app were used to modify and finalize the intervention. The results from the proposed study suggest that the e-Motivate app is highly feasible and acceptable. The next step in this line of research is to conduct a randomized clinical trial to formally test the efficacy of the e-Motivate app for improving screening colonoscopy rates among African Americans.",2020,"Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability.","[""African Americans' screening colonoscopy rates"", 'African Americans', '20 African Americans over the age of 50']",[],"['screening colonoscopy rates', 'highest colorectal cancer (CRC) morbidity and mortality rates']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",20.0,0.0196931,"Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Miller', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Jamilia R', 'Initials': 'JR', 'LastName': 'Sly', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Kemi B', 'Initials': 'KB', 'LastName': 'Gaffney', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Zhiye', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Henry', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jandorf', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz014']
1286,30688793,Participation in Physical Activity During Center and Home-Based Pulmonary Rehabilitation for People With COPD: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL.,"PURPOSE


To compare levels of physical activity during center and home-based pulmonary rehabilitation (PR) in people with chronic obstructive pulmonary disease.
METHODS


Forty-five consecutive participants (23 male, n = 20, in the home-based group) with mean age of 68 ± 8 yr and forced expiratory volume in the first second of expiration (FEV1) 53 ± 18% predicted undertook physical activity monitoring using the SenseWear Armband during the final week of the interventions of center or home-based PR. Differences in time spent in total physical activity (≥1.5 METs), time spent in moderate to vigorous intensity physical activity (≥3 METs), and steps were compared.
RESULTS


Home participants spent a median and interquartile range of 310 (199-328) min/d engaged in total physical activity (29% moderate to vigorous intensity physical activity) compared with 300 (204-370) min/d for the center group (28% moderate to vigorous intensity physical activity, P = .98). Daily step count did not differ between groups (home-based median 5232 [2067-7718] versus center-based median 4049 [1983-6040], P = .66). Of note, center-based participants took 38% more steps on days of program attendance compared with nonattendance days (mean difference: 761 steps/d; 95% CI, -56 to 1579, P = .06).
CONCLUSION


For people with chronic obstructive pulmonary disease undertaking PR, no differences in physical activity levels between center and home-based programs were demonstrated. Understanding the impact of the indirect supervision and motivational interviewing technique utilized during home-based PR on levels of physical activity in people with chronic obstructive pulmonary disease may support clinical implementation of the model as an alternative option to traditional care.",2019,"Differences in time spent in total physical activity (≥1.5 METs), time spent in moderate to vigorous intensity physical activity (≥3 METs), and steps were compared.
","['Forty-five consecutive participants (23 male, n = 20, in the home-based group) with mean age of 68 ± 8 yr and forced expiratory volume in the first second of expiration (FEV1) 53 ± 18% predicted undertook physical activity monitoring using the SenseWear Armband during the final week of the interventions of center or home-based PR', 'people with chronic obstructive pulmonary disease', 'Home participants spent a median and interquartile range of 310 (199-328) min', 'People With COPD']",['physical activity during center and home-based pulmonary rehabilitation (PR'],"['time spent in total physical activity (≥1.5 METs), time spent in moderate to vigorous intensity physical activity (≥3 METs), and steps', 'Daily step count', 'Physical Activity', 'total physical activity', 'physical activity levels']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",45.0,0.099366,"Differences in time spent in total physical activity (≥1.5 METs), time spent in moderate to vigorous intensity physical activity (≥3 METs), and steps were compared.
","[{'ForeName': 'Aroub', 'Initials': 'A', 'LastName': 'Lahham', 'Affiliation': ""Physiotherapy, La Trobe University, Melbourne, Victoria, Australia (Mss Lahham and Burge and Drs Lee, Cox, and Holland); Institute for Breathing and Sleep, Melbourne, Victoria, Australia (Mss Lahham, Burge, and Gillies and Drs McDonald, Lee, Hill, Cox, Moore, and Holland); Department of Respiratory and Sleep Medicine, Austin Health, Melbourne, Victoria, Australia (Dr McDonald); Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia (Dr McDonald); Nossal Institute for Global Health, The University of Melbourne, Melbourne, Victoria, Australia (Dr Mahal); Department of Physiotherapy, Alfred Hospital, Melbourne, Victoria, Australia (Mss Lee, Burge, Nicolson, and Holland); Department of Physiotherapy, Austin Hospital, Melbourne, Victoria, Australia (Mss Hill, Moore, and Gillies); and Public Health and Psychology, La Trobe University, Melbourne, Victoria, Australia (Dr O'Halloran).""}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': ''}, {'ForeName': 'Annemarie L', 'Initials': 'AL', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Angela T', 'Initials': 'AT', 'LastName': 'Burge', 'Affiliation': ''}, {'ForeName': 'Narelle S', 'Initials': 'NS', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nicolson', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'OʼHalloran', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gillies', 'Affiliation': ''}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000373']
1287,30785379,ICARUSS: An effective model for risk factor management in stroke survivors.,"BACKGROUND AND PURPOSE


After an initial stroke, the risk of recurrent stroke is high. Models that implement best-practice recommendations for risk factor management in stroke survivors to prevent stroke recurrence remain elusive. We examined a model which focuses on vascular risk factor management to prevent stroke recurrence in survivors returning to their primary care physicians. This model is coordinated from the stroke unit, integrates specialist stroke services with primary care physicians, and directly involves patients and carers in risk factor management. It is underpinned by the shared care principle in which there is joint participation of specialists as well as primary care physicians in a planned, integrated delivery of care with ongoing involvement of patients and carers, a structure which encourages implementation of best-practice recommendations as well as transferability and sustainability. We hypothesized that an integrated, multimodal intervention based on a shared-care model which supports joint participation of stroke specialists and primary care physicians would improve the implementation of best-practice recommendations for risk factor management in stroke survivors returning to the community.
METHODS


We undertook a double-blind randomized controlled trial, testing the model in three Australian cities using stroke survivors admitted to stroke units and discharged from hospital to return to their primary care physicians. The model was a shared care, multifaceted integrated program which included bidirectional feedback between general practitioner and specialist unit, education, and engagement of patient and carer in self-management with ongoing input from a multidisciplinary team. The primary endpoint was improvement or abolition of risk factors such as raised blood pressure, diabetes, hyperlipidemia, the modification of adverse life-style factors such as lack of exercise, smoking and alcohol abuse and adherence to preventive medication at one year. Intermediate measurement points were scheduled at three monthly intervals. Analysis was by intention to treat, evaluated by covariance or a linear model adjusting for confounding factors or variance of base-line risk factors. The study was registered as ACTRN = 1261100026498.
RESULTS


The study population was as follows: intervention ( n  = 112), control ( n  = 137). At baseline, there was no statistical difference between the groups for any variable. At the 12-month evaluation, there was a significant decrease in systolic blood pressure from baseline in the intervention group of 5.2 mmHg ( p  < 0.01). This change was not observed in the control group ( p  = 0.29). Moreover, at 12 months the mean systolic blood pressure in the intervention group was 129.4 mmHg (SD 14.7), a result which was not obtained in controls. Fasting total cholesterol as well as triglycerides was reduced significantly in the intervention group (both  p  < 0.01) but this was not the case in the control group ( p  = 0.11 and  p  = 0.27, respectively). At 12 months, there was no change in BMI in the intervention group but there was a significant increase in BMI ( p  = 0.02) in the control group. At 12 months in the intervention group, the mean distance walked with ease compared to the baseline measurements was increased by a mean distance of 600 m while in the control group the distance walked with ease was reduced compared to that measured at baseline. At 12 months, the Barthel index in the intervention group demonstrated improved function ( p  = 0.01), but no change was observed in controls. At 12 months in the intervention group, there was a significant decrease in number of standard alcoholic drinks consumed per week compared to the baseline ( p  = 0.04). This was not observed in the control group ( p  = 0.34).
CONCLUSION


In stroke survivors, the ICARUSS (Integrated Care for the Reduction of Secondary Stroke) model is superior to usual care with respect to best-practice recommendations for traditional risk factors as well as behavioral and functional outcomes.",2020,"At 12 months, the Barthel index in the intervention group demonstrated improved function ( p = 0.01), but no change was observed in controls.","['three Australian cities using stroke survivors admitted to stroke units and discharged from hospital to return to their primary care physicians', 'survivors returning to their primary care physicians', 'stroke survivors', 'stroke survivors returning to the community']","['vascular risk factor management', 'multifaceted integrated program which included bidirectional feedback between general practitioner and specialist unit, education, and engagement of patient and carer in self-management with ongoing input from a multidisciplinary team']","['number of standard alcoholic drinks', 'BMI', 'Fasting total cholesterol as well as triglycerides', 'improved function', 'improvement or abolition of risk factors such as raised blood pressure, diabetes, hyperlipidemia, the modification of adverse life-style factors such as lack of exercise, smoking and alcohol abuse and adherence to preventive medication at one year', 'mean distance walked with ease compared to the baseline measurements', 'systolic blood pressure', 'mean systolic blood pressure']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0277807', 'cui_str': 'Lack of physical exercise'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0343604,"At 12 months, the Barthel index in the intervention group demonstrated improved function ( p = 0.01), but no change was observed in controls.","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Joubert', 'Affiliation': ""Department of Neurology, St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': ""Department of Neurology, St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Hunter New England Local Health District Newcastle, New South Wales, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Gonzales', 'Affiliation': ""Department of Neurology, St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Joubert', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Sir Charles Gairdner Hospital, Nedlands, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019830582']
1288,30795958,Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials.,"BACKGROUND


Effective and well tolerated nucleos(t)ide analogue treatment exists for patients with chronic hepatitis B, although treatment is generally anticipated to be life-long, with concomitant costs and treatment-related side-effects. We aimed to characterise the outcomes of patients with persistent viral suppression who discontinued nucleotide analogue use after extended treatment.
METHODS


The primary objective of this prespecified analysis was to evaluate the safety of stopping long-term tenofovir disoproxil fumarate therapy in patients enrolled in two (completed) randomised controlled studies, GS-US-174-0102 (ClinicalTrials.gov, number NCT00117676) and GS-US-174-0103 (ClinicalTrials.gov, number NCT00116805). In those studies, patients who had completed 8 years or more of nucleotide analogue treatment, were hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV) DNA concentration of less than 29 IU/mL, and were unwilling or unable to continue therapy were required by protocol to enter a 24-week treatment-free follow-up (TFFU) phase. We present data for patients in the TFFU phase who were assessed at baseline and monitored every 4 weeks for changes in qualitative serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations in addition to standard safety assessments.
FINDINGS


Of 124 patients who entered the TFFU phase, 54 (44%) patients did not complete 24 weeks of follow-up (median 12 weeks; IQR 0-20). Overall, 32 (26%) patients reported an adverse event. Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient. 38 (31%) of patients had grade 3 or higher laboratory abnormalities, the majority of which were ALT elevations (36 patients). Of the 106 hepatitis B e antigen (HBeAg)-negative patients who entered the TFFU phase, 63 (59%) were followed for 24 weeks. HBsAg loss was observed in five (5%) of the 106 HBeAg-negative patients who entered the TFFU phase, and 37 (35%) had both HBV DNA concentrations of less than 2000 IU/mL and ALT concentrations less than the ULN at TFFU week 24. 18 HBeAg-positive patients entered the TFFU phase, of whom seven (39%) were followed up for 24 weeks. Of these seven patients, none had HBsAg loss or HBV DNA of less than 2000 IU/mL and one (14%) had an ALT less than the ULN at week 24.
INTERPRETATION


Within 24 weeks of stopping 8 years or more of nucleotide analogue therapy almost a third of patients experienced a grade 3 or higher laboratory abnormality. Although few patients achieved HBsAg loss, a subgroup of HBeAg-negative patients can achieve a low-replicative state within a short duration of follow-up.
FUNDING


Gilead Sciences, Inc.",2019,"Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient.","['patients with chronic hepatitis B following at least 8 years of therapy', '124 patients who entered the TFFU phase, 54 (44', 'patients with persistent viral suppression who discontinued nucleotide analogue use after extended treatment', '106 hepatitis B e antigen (HBeAg)-negative patients who entered the TFFU phase, 63 (59%) were followed for 24 weeks', 'patients enrolled in two (completed', 'patients with chronic hepatitis B']","['stopping tenofovir disoproxil fumarate', 'nucleotide analogue therapy', 'stopping long-term tenofovir disoproxil fumarate therapy']","['qualitative serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations', 'hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV) DNA concentration', 'HBsAg loss or HBV DNA', 'HBV DNA concentrations', 'hepatic flare', 'HBsAg loss', 'elevated ALT concentrations', 'adverse event', 'Serious adverse events', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0149709', 'cui_str': 'HBsAg positive'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.185683,"Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Liver Unit, Hospital Universitari Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain. Electronic address: mbuti@vhebron.net.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wong', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flisiak', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Helmholtz Center for Infection Research, Braunschweig, Hannover, Germany.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kaita', 'Affiliation': 'Viral Hepatitis Investigative Unit, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marjoleine', 'Initials': 'M', 'LastName': 'Op den Brouw', 'Affiliation': 'Gilead Sciences Europe, Uxbridge, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jump', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kitrinos', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flaherty', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marcellin', 'Affiliation': 'Viral Hepatitis Research Unit, Hôpital Beaujon, Clichy, France.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30015-9']
1289,30790597,"Combining CDP-choline and galantamine, an optimized α7 nicotinic strategy, to ameliorate sensory gating to speech stimuli in schizophrenia.","Neural α7 nicotinic acetylcholine receptor (nAChR) expression and functioning deficits have been extensively associated with cognitive and early sensory gating (SG) impairments in schizophrenia (SCZ) patients and their relatives. SG, the suppression of irrelevant and redundant stimuli, is measured in a conditioning-testing (S 1 -S 2 ) paradigm eliciting electroencephalography-derived P50 event-related potentials (ERPs), the S 2  amplitudes of which are typically suppressed relative to S 1 . Despite extensive reports of nicotine-related improvements and several decades of research, an efficient nicotinic treatment has yet to be approved for SCZ. Following reports of SG improvements in low P50 suppressing SCZ patients and healthy participants with the α7 agonist, CDP-choline, this pilot study examined the combined modulatory effect of CDP-choline (500 mg) and galantamine (16 mg), a nAChR positive allosteric modulator and acetylcholinesterase inhibitor, on SG to speech stimuli in twenty-four SCZ patients in a randomized, double-blind and placebo-controlled design. As expected, in low P50 suppressors CDP-choline/galantamine (vs. Placebo) improved rP50 and dP50 scores by increasing inhibitory mechanisms as reflected by S 2 P50 amplitude reductions. Results also suggest a moderating role for auditory verbal hallucinations in treatment response. These preliminary findings provide supportive evidence for the involvement of α7 nAChR activity in speech gating in SCZ and support additional trials, examining different dose combinations and repeated doses of this optimized and personalized targeted α7 cholinergic treatment for SG dysfunction in subgroups of SCZ patients.",2019,"As expected, in low P50 suppressors CDP-choline/galantamine (vs. Placebo) improved rP50 and dP50 scores by increasing inhibitory mechanisms as reflected by S 2 P50 amplitude reductions.","['low P50 suppressing SCZ patients and healthy participants', 'schizophrenia (SCZ) patients and their relatives']","['placebo', 'galantamine', 'CDP-choline', 'CDP-choline and galantamine', 'galantamine (vs. Placebo']","['auditory verbal hallucinations', 'rP50 and dP50 scores']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0219874', 'cui_str': 'tyrosine protein kinase p50csk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0780056,"As expected, in low P50 suppressors CDP-choline/galantamine (vs. Placebo) improved rP50 and dP50 scores by increasing inhibitory mechanisms as reflected by S 2 P50 amplitude reductions.","[{'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Choueiry', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Blais', 'Affiliation': 'Institute of Cognitive Science, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Dhrasti', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, Mount Saint Vincent University, Halifax, NS, Canada.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labelle', 'Affiliation': 'The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Verner', 'Initials': 'V', 'LastName': 'Knott', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; Institute of Cognitive Science, Carleton University, Ottawa, ON, Canada; School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada; Department of Psychology, Faculty of Social Sciences, Mount Saint Vincent University, Halifax, NS, Canada; The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada; University of Ottawa Institute of Mental Health Research, Ottawa, ON, Canada. Electronic address: verner.knott@theroyal.ca.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.02.005']
1290,31698917,Cardiac Magnetic Resonance Imaging used for Evaluation of Adipose-Derived Stromal Cell Therapy in Patients with Chronic Ischemic Heart Disease.,"Adipose-derived stromal cell (ASC) therapy is currently investigated as a new treatment option for patients with ischemic heart disease (IHD). The aim of this study was to evaluate the effect of ASC therapy in patients with chronic IHD measuring myocardial perfusion and cardiac function using cardiac magnetic resonance imaging (CMRI). Patients were included in MyStromalCell trial, a phase II, randomized, double-blinded, placebo-controlled study investigated the effect of ASCs in patients with chronic IHD with preserved left ventricular ejection fraction (LVEF). In total, 41 of 60 patients underwent cine, late enhancement, rest and stress imaging with CMRI. There was a non-significant difference between stress and rest values in maximal signal intensity, a measure of myocardial perfusion, from baseline to follow-up comparing placebo with ASC group (-52.52 ± 88.61 and 3.05 ± 63.17,  p  = 0.061, respectively). LVEF, myocardial mass, stroke volume, left ventricle end-diastolic volume and end-systolic volume changed non-significantly (-0.5 ± 4.7%, -3.5 ± 13.1 g, -0.7 ± 8.6 mL, 1.9 ± 25.1 mL and 2.6 ± 16.5 mL, respectively) in the placebo group and in the ASC group (0.7 ± 8.6%, 0.9 ± 10.8 g, -0.3 ± 26.1 mL, -3.0 ± 31.5 mL and -2.7 ± 20.4 mL, respectively) from baseline to 6 months follow-up. The amount of scar tissue was unchanged in the placebo group by 0.0 ± 1.6 g,  p  = 1.0 and in the ASC group with -0.3 ± 2.3 g,  p  = 0.540. There was no difference between the groups. There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.",2019,There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.,"['patients with ischemic heart disease (IHD', 'patients with chronic IHD with preserved left ventricular ejection fraction (LVEF', 'Patients with Chronic Ischemic Heart Disease', 'patients with chronic IHD measuring myocardial perfusion and cardiac function using']","['cardiac magnetic resonance imaging (CMRI', 'placebo', 'Adipose-derived stromal cell (ASC) therapy', 'Adipose-Derived Stromal Cell Therapy', 'Cardiac Magnetic Resonance Imaging', 'ASC therapy']","['LVEF, myocardial mass, stroke volume, left ventricle end-diastolic volume and end-systolic volume', 'amount of scar tissue', 'myocardial perfusion', 'stress and rest values in maximal signal intensity, a measure of myocardial perfusion', 'functional parameters or amount of scar tissue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0264694', 'cui_str': 'Chronic myocardial ischemia (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0225897', 'cui_str': 'Left Ventricle'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C2004491', 'cui_str': 'Scars'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.355122,There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Qayyum', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders Bruun', 'Initials': 'AB', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Naja Dam', 'Initials': 'ND', 'LastName': 'Mygind', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels Groove', 'Initials': 'NG', 'LastName': 'Vejlstrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}]",Cell transplantation,['10.1177/0963689719883592']
1291,30677539,"Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study.","BACKGROUND


Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.
OBJECTIVE


To evaluate the efficacy and safety of weight-based intravenous reslizumab dosing in patients who have previously failed therapy with omalizumab.
METHODS


We carried out a 24-week prospective, multicenter, open-label, single-group, self-controlled study in patients with severe eosinophilic asthma who had previously failed to respond to omalizumab. The main objective was to determine whether treatment with reslizumab significantly improved asthma symptoms assessed by the Asthma Control Test (ACT) at week 24. Secondary objectives were to evaluate symptoms at weeks 4 and 12, change in FEV 1  at week 24, and the incidence of severe exacerbations over the study period.
RESULTS


Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study. The median ACT score significantly increased from 13.0 (interquartile range, 8.0-18.0) at baseline to 21.0 (interquartile range, 14.0-24.0) at 24 weeks (P = .002). Only 2 of 29 patients developed at least 1 severe exacerbation during follow-up and none of them required hospitalization. Overall, 15 of 25 patients (60%) were considered as being controlled (ACT score of ≥20 and no exacerbations) at week 24. The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019). Adverse events were mostly moderate and within the range of previously reported side effects with reslizumab.
CONCLUSION


Reslizumab is an effective and safe option for patients with severe eosinophilic asthma and a history of omalizumab failure.",2019,The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019).,"['patients who have previously failed therapy with omalizumab', 'patients with severe eosinophilic asthma who had previously failed to respond to omalizumab', 'Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study', 'patients with severe eosinophilic asthma and a history of omalizumab failure', 'Patients with severe allergic and eosinophilic asthma', 'Patients with Severe Asthma with Inadequate Response to Omalizumab']","['reslizumab', 'Reslizumab', 'weight-based intravenous reslizumab']","['Adverse events', 'severe exacerbation', 'median ACT score', 'Efficacy and Safety', 'asthma symptoms', 'severe exacerbations', 'daily systemic corticosteroids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",,0.151391,The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019).,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Pérez de Llano', 'Affiliation': 'Pneumology Service, Hospital Universitario Lucus Agusti, Lugo, Spain. Electronic address: eremos26@hotmail.com.'}, {'ForeName': 'Borja G', 'Initials': 'BG', 'LastName': 'Cosío', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Domingo', 'Affiliation': 'Department of Pulmonary Medicine, Corporació Sanitària Parc Taulí, Sabadell, Spain; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Urrutia', 'Affiliation': 'Asthma Unit, Department of Pulmonary Medicine, Hospital Galdakao, Bizkaia, Spain.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bobolea', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona-Institute for Health Research (IdiBAPS), Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Valero', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona-Institute for Health Research (IdiBAPS), Madrid, Spain.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Entrenas Costa', 'Affiliation': 'Pneumology Service, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Barranco', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Marina Malanda', 'Affiliation': 'Department of Pulmonology, Hospital de Cruces, Bilbao, Spain.'}, {'ForeName': 'Luis Prieto', 'Initials': 'LP', 'LastName': 'Andrés', 'Affiliation': 'Allergy Section, Hospital Universitario Dr Peset, Valencia, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Alvarez-Gutiérrez', 'Affiliation': 'Asthma Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.017']
1292,31699751,Best emollients for eczema (BEE) - comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study.,"INTRODUCTION


Atopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend 'leave-on' emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease 'flares'. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first.
METHODS AND ANALYSIS


Design: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments).
SETTING


general practitioner surgeries in England.
PARTICIPANTS


children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients.
INTERVENTIONS


study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care.
FOLLOW-UP


52 weeks.
PRIMARY OUTCOME


validated patient-orientated eczema measure measured weekly for 16 weeks.
SECONDARY OUTCOMES


eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
SAMPLE SIZE


520 participants (130 per group).
ANALYSIS


intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically.
ETHICS AND DISSEMINATION


Ethics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders.
TRIAL REGISTRATION NUMBER


ISRCTN84540529.",2019,"OUTCOMES


eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
","['520 participants (130 per group', 'children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients', 'general practitioner surgeries in England', 'children with eczema']","['emollient (lotions, creams, gel or ointments', 'lotion, cream, gel or ointment']","['eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact']","[{'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034380'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",520.0,0.186668,"OUTCOMES


eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ridd', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK m.ridd@bristol.ac.uk.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'MacNeill', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Sutton', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alison R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Banks', 'Affiliation': 'National Institute for Health Research Collaborations for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Nottingham Support Group for Carers of Children with Eczema, Nottingham, UK.'}, {'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Barrett', 'Affiliation': 'South West Medicines Information & Training, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baxter', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kim Suzanne', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033387']
1293,31697573,"The effect of the artificial sweeteners on glucose metabolism in healthy adults: a randomized, double-blinded, crossover clinical trial.","This study aimed to determine the effect of pure forms of sucralose and aspartame, in doses reflective of common consumption, on glucose metabolism. Healthy participants consumed pure forms of a non-nutritive sweetener (NNS) that were mixed with water and standardized to doses of 14% (0.425 g) of the acceptable daily intake (ADI) for aspartame and 20% (0.136 g) of the ADI for sucralose every day for 2 weeks. Blood samples were collected and analyzed for glucose, insulin, active glucagon-like peptide-1 (GLP-1), and leptin. Seventeen participants (10 females and 7 males; age, 24 ± 6.8 years; body mass index, 22.9 ± 2.5 kg/m 2 ) participated in the study. The total area under the curve values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared with the baseline values in healthy participants. There was no change in insulin sensitivity after NNS treatment compared with the baseline values. These findings suggest that daily repeated consumption of pure sucralose or aspartame for 2 weeks had no effect on glucose metabolism among normoglycaemic adults. However, these results need to be tested in studies with longer durations.  Novelty  Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on glucose metabolism. Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on insulin sensitivity among healthy adults.",2020,"The total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared to the baseline values in healthy participants.","['normoglycaemic adults', 'Healthy participants consumed pure forms of a non-nutritive sweetener (NNS) mixed with water that were standardized to doses of 14% (0.425 g) of the', 'Seventeen participants (10 females and 7 males; age 24 ± 6.8 years; BMI 22.9 ± 2.5 kg/m2) participated in the study', 'healthy participants', 'healthy adults']","['pure aspartame or sucralose', 'acceptable daily intake (ADI) for aspartame', 'pure sucralose or aspartame', 'sucralose and aspartame', 'artificial sweeteners']","['insulin sensitivity', 'total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin', 'Novelty', 'glucose metabolism', 'glucose, insulin, active glucagon-like peptide-1 (GLP-1), and leptin']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3658246', 'cui_str': 'High-Intensity Sweeteners'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C3658296', 'cui_str': 'Tolerable Daily Intake'}, {'cui': 'C0003920', 'cui_str': 'Artificial Sweeteners'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",17.0,0.403176,"The total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared to the baseline values in healthy participants.","[{'ForeName': 'Samar Y', 'Initials': 'SY', 'LastName': 'Ahmad', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Friel', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'MacKay', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0359']
1294,30786315,Digital cholangioscopy-guided laser versus mechanical lithotripsy for large bile duct stone removal after failed papillary large-balloon dilation: a randomized study.,"BACKGROUND


Endoscopic papillary large-balloon dilation (EPLBD) allows for the complete removal of large common bile duct (CBD) stones without fragmentation; however, a significant proportion of very large stones and stones floating above a tapering CBD require lithotripsy. Mechanical lithotripsy and cholangioscopy-guided laser lithotripsy are both effective for stone fragmentation. This study aimed to directly compare, for the first time, the efficacy of these two techniques in terms of stone clearance rate, procedure duration, patient radiation exposure, and safety.
METHODS


32 patients with very large CBD stones or with stones floating above a tapering CBD, and in whom extraction after standard sphincterotomy and/or EPLBD had failed, were randomly assigned to mechanical lithotripsy or cholangioscopy-guided laser lithotripsy at two tertiary referral centers. Crossover was allowed as a rescue treatment if the assigned technique failed.
RESULTS


Patients' demographic data were not different between the two groups. Mechanical lithotripsy had a significantly lower stone clearance rate in the first session compared with laser lithotripsy (63% vs. 100%;  P  < 0.01). Laser lithotripsy rescued 60% of patients with failed mechanical lithotripsy by achieving complete stone clearance within the same session. Radiation exposure of patients was significantly higher in the mechanical lithotripsy group than in the laser lithotripsy group (40 745 vs. 20 989 mGycm 2 ;  P   = 0.04). Adverse events (13% vs. 6%;  P   = 0.76) and length of hospital stay (1 vs. 1 day;  P   = 0.27) were not different.
CONCLUSIONS


Although mechanical lithotripsy is the standard of care for a very large CBD stone after failed EPLBD, where available, cholangioscopy-guided laser lithotripsy is considered the better option for the treatment of this entity as it provides a higher success rate and lower radiation exposure.",2019,Mechanical lithotripsy had a significantly lower stone clearance rate in the first session compared with laser lithotripsy (63% vs. 100%;  P  < 0.01).,"['32 patients with very large CBD stones or with stones floating above a tapering CBD, and in whom extraction after standard sphincterotomy and/or EPLBD had failed', 'large bile duct stone removal after failed papillary large-balloon dilation']","['laser lithotripsy', 'Endoscopic papillary large-balloon dilation (EPLBD', 'Digital cholangioscopy-guided laser versus mechanical lithotripsy', 'Mechanical lithotripsy and cholangioscopy-guided laser lithotripsy', 'mechanical lithotripsy or cholangioscopy-guided laser lithotripsy at two tertiary referral centers', 'Mechanical lithotripsy', 'Laser lithotripsy', 'mechanical lithotripsy']","['Adverse events', 'complete stone clearance', 'length of hospital stay', 'stone clearance rate, procedure duration, patient radiation exposure, and safety', 'stone clearance rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1272624', 'cui_str': 'Bile duct stone removal (procedure)'}, {'cui': 'C0205312', 'cui_str': 'Papillary (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C0206099', 'cui_str': 'Lithotripsy, Laser'}, {'cui': 'C0205312', 'cui_str': 'Papillary (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.0374781,Mechanical lithotripsy had a significantly lower stone clearance rate in the first session compared with laser lithotripsy (63% vs. 100%;  P  < 0.01).,"[{'ForeName': 'Phonthep', 'Initials': 'P', 'LastName': 'Angsuwatcharakon', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Santi', 'Initials': 'S', 'LastName': 'Kulpatcharapong', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Wiriyaporn', 'Initials': 'W', 'LastName': 'Ridtitid', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Chaloemphon', 'Initials': 'C', 'LastName': 'Boonmee', 'Affiliation': 'Department of Surgery, Thabo Crown Prince Hospital, Nong Khai, Thailand.'}, {'ForeName': 'Panida', 'Initials': 'P', 'LastName': 'Piyachaturawat', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Pradermchai', 'Initials': 'P', 'LastName': 'Kongkam', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Wattana', 'Initials': 'W', 'LastName': 'Pareesri', 'Affiliation': 'Department of Surgery, Thabo Crown Prince Hospital, Nong Khai, Thailand.'}, {'ForeName': 'Rungsun', 'Initials': 'R', 'LastName': 'Rerknimitr', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}]",Endoscopy,['10.1055/a-0848-8373']
1295,30768388,Families Who Benefit and Families Who Do Not: Integrating Person- and Variable-Centered Analyses of Parenting Intervention Responses.,"OBJECTIVE


Families with disruptive child behavior are typically referred to services based on children's behavior alone, rather than on underlying mechanisms of disruptive behavior. Yet, the presence of the precise mechanisms targeted by services might be essential for intervention success. We integrated person- and variable-centered approaches to test whether families with combined disruptive child behavior and harsh/inconsistent parenting indeed benefit most from a behavioral parenting intervention in indicated prevention context, compared to families with disruptive child behavior but less harsh/inconsistent parenting, and families with less severe disruptive behavior.
METHOD


Families (N = 387) of children aged 4 to 8 years (disruptive behavior >75 th  percentile) participated in a randomized trial of the Incredible Years parenting intervention (Trial NTR3594, www.trialregister.nl). We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
RESULTS


Most intervention group families (82%) showed a nonresponse trajectory. A minority (18%) showed a response trajectory with strong reductions in disruptive behavior (Cohen's d =1.45). As expected, families with both child and parenting difficulties were most likely to respond: 20% more than families with only child difficulties, and 40% more than families with less severe difficulties.
CONCLUSION


Incredible Years, as an indicated prevention program, benefits mainly families in which the mechanisms targeted by the intervention (ie, harsh/inconsistent parenting) is actually present, rather than all families. Careful matching of children to services based on assessments of both child and parenting behavior seems critical for intervention success.
CLINICAL TRIAL REGISTRATION INFORMATION


ORCHIDS: Study on Children's Genetic Susceptibility to Their Environment; https://www.trialregister.nl; 3594.",2019,"We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
","['families with disruptive child behavior but less harsh/inconsistent parenting, and families with less severe disruptive behavior', ""Children's Genetic Susceptibility to Their Environment; www.trialregister.nl;\xa03594"", 'Families (N\xa0= 387) of children aged 4 to 8 years (disruptive behavior >75 th  percentile', 'Families Who Benefit and Families', 'Families with disruptive child behavior']",['behavioral parenting intervention'],"['nonresponse trajectory', 'disruptive behavior']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0314657', 'cui_str': 'Genetic Susceptibility'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",[],"[{'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}]",,0.0443762,"We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
","[{'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'van Aar', 'Affiliation': 'University of Amsterdam, The Netherlands. Electronic address: JolienvanAar@gmail.com.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Leijten', 'Affiliation': 'University of Amsterdam, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Orobio de Castro', 'Affiliation': 'Utrecht University, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Weeland', 'Affiliation': 'University of Amsterdam, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Matthys', 'Affiliation': 'Utrecht University, The Netherlands.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Chhangur', 'Affiliation': 'University of Amsterdam, The Netherlands; Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'University of Amsterdam, The Netherlands.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.02.004']
1296,32408153,Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.,"BACKGROUND


Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions.
OBJECTIVE


Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs).
METHODS


We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data.
RESULTS


A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis.
CONCLUSION


The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.",2020,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","['people with MS', 'Participants who were able to adhere to a calorie restriction diet predictably lost weight', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'People with Multiple Sclerosis (MS) - NCT02846558', 'A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported']","['Dietary Programs', 'various fasting-mimicking diets', 'Intermittent Calorie Restriction', 'several fasting-mimicking diets']","['PROs', 'calorie restriction (daily or intermittently) or time-restricted feeding', 'Overall adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",90.0,0.0618671,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Roman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State. Electronic address: sroman6@jhmi.edu.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Mowry', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102149']
1297,30625372,STRONG-D: Strength training regimen for normal weight diabetics: Rationale and design.,"BACKGROUND


Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Standard T2DM treatment recommends aerobic training; however, performing aerobic training alone may not be appropriate for NWD and strength training may be a more effective treatment recommendation.
OBJECTIVE


While it is known that strength and aerobic training are beneficial in obese diabetics, there is currently insufficient evidence to recommend this regimen in NWD. The Strength Training Regimen for Normal Weight Diabetics (STRONG-D) study aims to determine the best exercise regimen for NWD and address the current lack of appropriate physical activity recommendations for this population. The primary goal of this study is to determine whether strength training aids glycemic control better than aerobic training in NWD.
STUDY DESIGN


STRONG-D is a three-arm randomized controlled trial designed to compare the clinical effectiveness of structured strength training only, aerobic training only, and combination (strength + aerobic) training sessions, modeled after the intervention in the Health Benefits of Aerobic and Resistance Training in T2DM patients (HART-D) study. Potential participants meeting eligibility criteria of HbA1c values of 6.5% to 13.0% and BMI of 18.5 kg/m 2  to 25 kg/m 2  will be enrolled. After randomization, participants will begin a 9-month exercise intervention. The primary outcomes will be HbA1c levels. The secondary endpoints will include physical fitness, body composition measured by Dual X-Ray Absorptiometry (DXA) scans, and leg strength and endurance measured by Biodex testing. Initial follow-up visits will occur at 3 months, 6 months, and 9 months. To determine the long-term effects of the exercise intervention, passive follow-up will continue via electronic health records (EHR) until a 24-month follow-up visit. A total of 282 participants will be randomized into the three study arms determine the clinically significant differences between strength-only, aerobic-only and combination regimens.",2019,"A total of 282 participants will be randomized into the three study arms determine the clinically significant differences between strength-only, aerobic-only and combination regimens.","['5 individuals with Type II Diabetes Mellitus (T2DM', 'Normal Weight Diabetics', 'patients with normal-weight diabetes (NWD', 'T2DM patients (HART-D) study', 'Potential participants meeting eligibility criteria of HbA1c values of 6.5% to 13.0% and BMI of 18.5\u202fkg/m 2  to 25\u202fkg/m 2  will be enrolled', 'obese diabetics', 'normal weight diabetics', '282 participants', 'normal-weight diabetics (NWD']","['strength training aids glycemic control better than aerobic training', 'Strength Training Regimen', 'structured strength training only, aerobic training only, and combination (strength + aerobic) training sessions', 'aerobic training', 'exercise intervention', 'Specific exercise']","['physical fitness, body composition measured by Dual X-Ray Absorptiometry (DXA) scans, and leg strength and endurance measured by Biodex testing', 'HbA1c levels', 'mortality rates']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1285593', 'cui_str': 'Body composition measure'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0441633'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",282.0,0.0514443,"A total of 282 participants will be randomized into the three study arms determine the clinically significant differences between strength-only, aerobic-only and combination regimens.","[{'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Faroqi', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States. Electronic address: lfaroqi@stanford.edu.'}, {'ForeName': 'Saniya', 'Initials': 'S', 'LastName': 'Bonde', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Daniella Tatianna', 'Initials': 'DT', 'LastName': 'Goni', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Chi Wai', 'Initials': 'CW', 'LastName': 'Wong', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Myo', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Walai', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Saron', 'Initials': 'S', 'LastName': 'Araya', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Azamey', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Schreiner', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bandy', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Sonia Sunita', 'Initials': 'SS', 'LastName': 'Raghuram', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Anuva', 'Initials': 'A', 'LastName': 'Mittal', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Aishee', 'Initials': 'A', 'LastName': 'Mukherji', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Tenzin', 'Initials': 'T', 'LastName': 'Wangdak', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Talamoa', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vera', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nacif-Coelho', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Leah Groppo', 'Initials': 'LG', 'LastName': 'Cde', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Stanford Health Care, Palo Alto, CA, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Johannsen', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, United States.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Moharir', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Palaniappan', 'Affiliation': 'Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.005']
1298,30765264,"Laparoscopic versus open adhesiolysis for adhesive small bowel obstruction (LASSO): an international, multicentre, randomised, open-label trial.","BACKGROUND


Although laparoscopic adhesiolysis for adhesive small bowel obstruction is being done more frequently, it is not widely accepted due to the lack of supporting evidence of its superiority over an open approach and concerns regarding its benefits. We aimed to investigate whether laparoscopic adhesiolysis was a superior treatment for adhesive small bowel obstruction compared with an open approach in terms of length of postoperative hospital stay and morbidity.
METHODS


In this international, multicentre, parallel, open-label trial, we randomly assigned patients (1:1) aged 18-95 years who had adhesive small bowel obstruction that had not resolved with conservative management to have either open or laparoscopic adhesiolysis. The study was done in five academic university hospitals and three community (central) hospitals in two countries (Finland [n=3 academic university hospitals; n=3 community hospitals] and Italy [n=2 academic university hospitals]). We included only patients with high likelihood of a single adhesive band in the trial; additionally, patients who had an anaesthesiological contraindication, were pregnant, living in institutionalised care, or who had a hospital stay of more than 1 week before the surgical consultation were excluded from the trial. The randomisation sequence was generated using block randomisation, with randomly varied block sizes and stratified according to centre. The primary outcome was postoperative length of hospital stay assessed at time of discharge in the modified intention-to-treat population.
FINDINGS


Between July 18, 2013, and April 9, 2018, 566 patients were assessed for eligibility, of whom 104 patients were randomly assigned to the open surgery group (n=51) or to the laparoscopy group (n=53). Of these patients, 100 were included in the modified intention-to-treat analyses (49 in the open surgery group; 51 in the laparoscopy group). The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days [range 1 -20]; ratio of geometric means 1·31 [95% CI 1·06-1·61]; p=0·013). 21 (43%) patients in the open surgery group and 16 (31%) patients in the laparoscopy group had postoperative complications (Clavien-Dindo any grade) within 30 days (odds ratio 0·61 [95% CI 0·27-1·38]; p=0·23). One patient died in each group within 30 days.
INTERPRETATION


Laparoscopic adhesiolysis provides quicker recovery in selected patients with adhesive small bowel obstruction than open adhesiolysis.
FUNDING


Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, Martti I Turunen Foundation, and governmental (Finland) competitive research funds (EVO/VTR/TYH).",2019,The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days,"['selected patients with adhesive small bowel obstruction than open adhesiolysis', 'Of these patients, 100 were included in the modified intention-to-treat analyses (49 in the open surgery group; 51 in the laparoscopy group', 'patients with high likelihood of a single adhesive band in the trial; additionally, patients who had an anaesthesiological contraindication, were pregnant, living in institutionalised care, or who had a hospital stay of more than 1 week before the surgical consultation were excluded from the trial', '0·61', 'adhesive small bowel obstruction (LASSO', 'Between July 18, 2013, and April 9, 2018, 566 patients were assessed for eligibility, of whom 104 patients', 'randomly assigned patients (1:1) aged 18-95 years who had adhesive small bowel obstruction that had not resolved with conservative management to have either open or laparoscopic adhesiolysis', 'five academic university hospitals and three community (central) hospitals in two countries (Finland [n=3 academic university hospitals; n=3 community hospitals] and Italy [n=2 academic university hospitals']","['laparoscopic adhesiolysis', 'laparoscopy', 'Laparoscopic versus open adhesiolysis']","['postoperative complications', 'postoperative length of hospital stay', 'postoperative hospital stay and morbidity', 'postoperative length of hospital stay assessed at time of discharge in the modified intention-to-treat population']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0198539', 'cui_str': 'Laparoscopic adhesiolysis'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0198539', 'cui_str': 'Laparoscopic adhesiolysis'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",566.0,0.224955,The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days,"[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: ville.sallinen@helsinki.fi.'}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'Di Saverio', 'Affiliation': ""Maggiore Hospital Bologna, Bologna, Italy; Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, UK.""}, {'ForeName': 'Eija', 'Initials': 'E', 'LastName': 'Haukijärvi', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Juusela', 'Affiliation': 'Vaasa Central Hospital, Vaasa, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wikström', 'Affiliation': 'Peijas Hospital, Vantaa, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Koivukangas', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Catena', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'Berndt', 'Initials': 'B', 'LastName': 'Enholm', 'Affiliation': 'Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Birindelli', 'Affiliation': 'Department of Surgery, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Leppäniemi', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Mentula', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30016-0']
1299,30765242,"Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial.","BACKGROUND


The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella.
METHODS


This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499.
FINDINGS


Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths.
INTERPRETATION


The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination.
FUNDING


GlaxoSmithKline Biologicals.",2019,Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V.,"['5803 children (mean age 14·2 months, SD 2·5) were vaccinated', '2279 children from the MMRV group, 2266 from the MMR\u2008+\u2008V group, and 744 from the MMR group', 'children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden']","['combined measles-mumps-rubella-varicella vaccine', 'monovalent varicella vaccine', 'combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR\u2008+\u2008V), versus two MMR doses (control vaccine', 'MMRV, one dose of MMR and one dose of varicella vaccine']","['vaccine efficacy against moderate or severe varicella', '10-year vaccine efficacy', 'Hazard ratios for MMRV and MMR\u2008+\u2008V versus MMR', 'Vaccine efficacy', 'serious adverse events', 'Serious adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0206579', 'cui_str': 'Slovak Republic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0078048', 'cui_str': 'Varicella Vaccine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2279.0,0.272594,Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Ouzama', 'Initials': 'O', 'LastName': 'Henry', 'Affiliation': 'GlaxoSmithKline, Rockville, MD, USA.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Riise Bergsaker', 'Affiliation': 'Division of Health Services, Department of Global Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Chlibek', 'Affiliation': 'University of Defence, Faculty of Military Health Sciences, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Carl-Erik', 'Initials': 'CE', 'LastName': 'Flodmark', 'Affiliation': 'Department of Paediatrics, Skånes University Hospital, Malmo, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Gothefors', 'Affiliation': 'The Public Health Agency of Sweden and Department of Clinical Sciences/Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Man', 'Affiliation': '3rd Pediatric Department, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Sven-Arne', 'Initials': 'SA', 'LastName': 'Silfverdal', 'Affiliation': 'Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Štefkovičová', 'Affiliation': 'Faculty of Health Care, Alexander Dubček University of Trenčín, Trenčín, Slovakia.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Usonis', 'Affiliation': ""Clinic of Children's Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Wysocki', 'Affiliation': 'Department of Preventive Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Prymula', 'Affiliation': 'University of Defence, Faculty of Military Health Sciences, Hradec Kralove, Czech Republic; Charles University, Faculty of Medicine in Hradec Kralove, Department of Social Medicine, Hradec Kralove, Czech Republic.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30716-3']
1300,30737183,Effects of suvorexant on sleep apnea in patients with heart failure: A protocol of crossover pilot trial.,"BACKGROUND


Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF.
METHODS


The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant.
CONCLUSION


The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.",2019,Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order.,"['Many patients with heart failure (HF', 'patients with HF.\nMETHODS\n\n\nThe Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial', 'patients with heart failure', 'Eligible patients will undergo', 'patients with HF', 'HF patients without affecting their SDB', '30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital']","['portable sleep monitoring twice with or without oral administration of suvorexant', 'suvorexant']","['sleep apnea', 'non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",30.0,0.0926004,Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shitara', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sleep and Sleep Disordered Breathing Center, Juntendo University Hospital, Tokyo, Japan. Electronic address: kasai-t@mx6.nisiq.net.'}, {'ForeName': 'Sato', 'Initials': 'S', 'LastName': 'Akihiro', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Yatsu', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Suda', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Ogita', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Yanagisawa', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Fujibayashi', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nishizaki', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Ono', 'Affiliation': 'Faculty of International Liberal Arts, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2018.12.021']
1301,30639752,"Preliminary efficacy and feasibility of referral to exercise specialists, psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers 'at risk' of, or diagnosed with, type 2 diabetes: The 'SMART Health' Pilot Study Protocol.","INTRODUCTION


Type 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers 'at risk' of or diagnosed with T2DM.
RESEARCH DESIGN AND METHODS


The SMART (Support, Motivation and Physical Activity Research for Teachers') Health pilot study will be evaluated using a three-arm randomized controlled trial. The intervention will be guided by Social Cognitive Theory, Health Action Process Approach Model and Cognitive Behavioral Therapy strategies. The participants will be randomly allocated to one of three study groups: Group 1: wait-list control group; Group 2: 5 face-to-face visits with a psychologist and exercise specialist over 3 months; and Group 3: same as Group 2 plus technology-based behavior change support package for an additional 6 months. Assessments will be conducted at baseline, 3-, 9- (primary time-point) and 18-months post-baseline. The primary outcome will be PA measured with pedometers.
DISCUSSION


SMART Health is an innovative, multi-component intervention, that integrates referral to exercise specialists, psychologists and provision of a technology-based behavior support package to promote PA and RT in adults diagnosed with T2DM or 'at risk' of T2DM. The findings will be used to guide future PA interventions and to develop effective community-based diabetes prevention and treatment programs.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry No: ACTRN12616001309471.",2019,Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM.,"[""adults diagnosed with T2DM or 'at risk' of T2DM"", 'Teachers', ""school teachers 'at risk' of, or diagnosed with, type 2 diabetes"", ""school teachers 'at risk' of or diagnosed with T2DM""]","['wait-list control group; Group 2: 5 face-to-face visits with a psychologist and exercise specialist over 3 months; and Group 3: same as Group 2 plus technology-based behavior change support package', 'Aerobic physical activity (PA) and resistance training (RT', 'technology-based behavior change support package']",['PA measured with pedometers'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0036374', 'cui_str': 'School Teachers'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C1278655', 'cui_str': 'SAME AS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0445979,Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM.,"[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Murphy', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: maria.murphy@oun.edu.au.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: david.lubans@newcastle.edu.au.'}, {'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Cohen', 'Affiliation': 'University of New England, Armidale, NSW 2351, Australia. Electronic address: kcohen4@une.edu.au.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Robards', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: sara.robards@newcastle.edu.au.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wilczynska', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia; University of Newcastle, School of Psychology, Australia. Electronic address: magdalena.wilczynska@newcastle.edu.au.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Kennedy', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: sarah.kennedy@newcastle.edu.au.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'James', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: erica.james@newcastle.edu.au.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, QLD 4072, Australia. Electronic address: wbrown@uq.edu.au.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, 1-113 University Hall, University of Alberta, Edmonton, Alberta T6G 2H9, Canada. Electronic address: kerry.courneya@ualberta.ca.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'University of Calgary, 2500 University Dr, NW, Calgary, AB T2N 1N4, Canada. Electronic address: rsigal@ucalgary.ca.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address: Ron.Plotnikoff@newcastle.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.007']
1302,31694851,The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia.,"INTRODUCTION


Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on 'trial and error'. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking.
METHODS AND ANALYSIS


In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained.
TRIAL REGISTRATION NUMBER


NTR6982; Pre-results.",2019,"We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed.","['Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022', 'newborns with PH without CDH', 'pulmonary hypertension in neonates with congenital diaphragmatic hernia']","['Congenital diaphragmatic hernia (CDH', 'sildenafil', 'Intravenous sildenafil', 'sildenafil or iNO', 'Sildenafil', 'nitric oxide', 'Inhaled nitric oxide (iNO']","['mortality', 'clinical and echocardiographic markers of PH in the first year of life', 'absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life']","[{'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0235833', 'cui_str': 'Congenital Diaphragmatic Defect'}]","[{'cui': 'C0235833', 'cui_str': 'Congenital Diaphragmatic Defect'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",330.0,0.278438,"We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed.","[{'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Cochius-den Otter', 'Affiliation': 'Department of Intensive care and Pediatric Surgery, Erasmus University Rotterdam, Rotterdam, The Netherlands s.denotter@erasmusmc.nl.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schaible', 'Affiliation': 'Department of Neonatology, University Medical Center, Mannheim, Mannheim, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'van Heijst', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Neonatology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Allegaert', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': 'Department of Intensive care and Pediatric Surgery, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032122']
1303,31697244,A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial.,"BACKGROUND


Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy.
OBJECTIVE


This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app.
METHODS


Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t 1 ), midintervention (t 4 =4 weeks after t 1 ) and postintervention (t 8 =8 weeks after t 1 ). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance.
RESULTS


Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t 4  and t 8  assessments were equally distributed between groups (t 4 : control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t 8 : control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively).
CONCLUSIONS


The well-being mobile app was effective in reducing employee stress and improving well-being.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.",2019,"Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively).
","['653 individuals self-enrolled through the website', 'Working Women', 'Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads', 'randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol', 'Eligible participants were randomized between control (n=240) and intervention (n=250) groups']",[],"['employee stress and improving well-being', 'conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization', 'general well-being as a function of time', 'work-related and overall stress']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043215', 'cui_str': 'Women, Working'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600191', 'cui_str': 'Intranets'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",185.0,0.0876708,"Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively).
","[{'ForeName': 'Cássia Canha', 'Initials': 'CC', 'LastName': 'Coelhoso', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Patricia Renovato', 'Initials': 'PR', 'LastName': 'Tobo', 'Affiliation': 'Natura Cosméticos SA, Cajamar, Brazil.'}, {'ForeName': 'Shirley Silva', 'Initials': 'SS', 'LastName': 'Lacerda', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Alex Heitor', 'Initials': 'AH', 'LastName': 'Lima', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Carla Regina Camara', 'Initials': 'CRC', 'LastName': 'Barrichello', 'Affiliation': 'Natura Cosméticos SA, Cajamar, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Elisa Harumi', 'Initials': 'EH', 'LastName': 'Kozasa', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}]",Journal of medical Internet research,['10.2196/14269']
1304,31696739,Extracranial activation of ATP-sensitive potassium channels induces vasodilation without nociceptive effects.,"INTRODUCTION


Levcromakalim opens ATP-sensitive potassium channels (K ATP  channel) and induces head pain in healthy volunteers and migraine headache in migraine patients, but no pain in other parts of the body. K ATP  channels are expressed in C- and Aδ-fibers, and these channels might directly activate nociceptors and thereby evoke pain in humans.
METHODS


To assess the local effect of K ATP  channel opening in trigeminal and extra-trigeminal regions, we performed a crossover, double-blind, placebo-controlled study in healthy volunteers. Participants received intradermal and intramuscular injections of levcromakalim and placebo in the forehead and the forearms.
RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05). Intradermal injection of levcromakalim caused more flare ( p  < 0.001 ) , skin temperature increase ( p  < 0.001), and skin blood flow increase ( p  < 0.001) compared to placebo in the forehead and the forearms.
CONCLUSION


These findings suggest that it is unlikely that levcromakalim induces head pain by direct activation of peripheral neurons.",2019,"RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05).","['in trigeminal and extra-trigeminal regions', 'healthy volunteers and migraine headache in migraine patients', 'healthy volunteers']","['levcromakalim', 'intradermal and intramuscular injections of levcromakalim and placebo', 'placebo', 'Levcromakalim opens ATP-sensitive potassium channels (K ATP  channel', 'K ATP  channel opening']","['skin blood flow increase', 'pain', 'skin temperature increase ']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0244960', 'cui_str': 'Levcromakalim'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",,0.0650602,"RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05).","[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Aghazadeh', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lene Theil', 'Initials': 'LT', 'LastName': 'Skovgaard', 'Affiliation': 'Department of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888490']
1305,30744396,Cognitive behaviour therapy for insomnia and depression: qualitative reflections from older adults who participated in a randomised controlled trial.,"Objectives:  To explore the experiences of older adults who participated in a randomised controlled trial (RCT) that tested cognitive behaviour therapy for insomnia and depression. Methods:  Focus groups were conducted post treatment for older adults ( M  age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+). Six semi-structured focus group interviews ( N  = 31) were analysed using a qualitative thematic analysis. Results:  Interview data were transcribed into 424 sentences and 60 codes were extracted. Thirty-four initial themes emerged, which were transformed into 3 themes and 10 subthemes. The three primary themes were (1) positive experiences, (2) negative experiences, and (3) suggested modifications. The positive subthemes were (1a) therapists, (1b) togetherness, (1c) use of strategies reduced symptoms, and (1d) acceptance. The negative subthemes were (2a) persistent symptoms, (2b) program too condensed, and (2c) attendance obstacles. The suggested modifications were (3a) lengthen program, (3b) multi-dimensional learning, and (3c) multi-modal delivery options. Conclusion:  The experiences and suggestions identified in this study strengthen the foundation to advance therapeutic program development for older adults with comorbid insomnia and depression. Future CBT-I programs for older adults may be improved by increasing the length of therapy (e.g. 8 sessions to 12 sessions), adding multi-dimensional learning opportunities (e.g. visual/audio/mentorship), and offering various modes of treatment delivery (e.g. group, individual, internet, telephone).",2020,"METHODS


Focus groups were conducted post treatment for older adults (M age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+).","['older adults', 'older adults (M age = 75\u2009years; 61% female) who participated in a', 'older adults with comorbid insomnia and depression', 'older adults who participated']","['RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I', 'Cognitive behaviour therapy', 'cognitive behaviour therapy']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",[],,0.0254088,"METHODS


Focus groups were conducted post treatment for older adults (M age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sadler', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McLaren', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Deputy Vice Chancellor-Research and Innovation Portfolio, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}]",Aging & mental health,['10.1080/13607863.2019.1571013']
1306,30740877,A randomized controlled trial on the effect of topical phenytoin 2% on wound healing after anal fistulotomy.,"AIM


Laying open fistulotomy is the standard treatment for simple anal fistula. However, healing of the resultant anal wound may be prolonged and may adversely affect a patient's lifestyle and work. This randomized trial aimed to assess the effect of topical phenytoin 2% powder spray on healing of the anal wound following fistulotomy.
METHOD


Adult patients with simple anal fistula who underwent anal fistulotomy were divided into two equal groups: group I applied topical phenytoin 2% powder spray on the anal wound regularly with sitz baths until complete healing was confirmed clinically and group II had regular sitz baths only. The primary outcome of the study was time to complete wound healing. Secondary outcomes were postoperative pain, complications, time to return to work and impact on lifestyle.
RESULTS


Sixty patients (50 of whom were men) with a mean age of 41.4 ± 12.5 years were included. Both groups had comparable pain scores at 1 week after surgery (1 ± 0.83 vs 0.86 ± 0.81; P = 0.51). The duration to complete wound healing was 41.2 ± 2.4 days in group I and 42 ± 2.5 days in group II (mean ± SD, P = 0.21). The time to return to work was 13.5 ± 2.8 days in group I and 14.1 ± 2.6 days in group II (mean ± SD, P = 0.39). No significant differences were noted between the two groups with regard to postoperative complications or impact on lifestyle.
CONCLUSION


The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.",2019,"The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.","['Sixty patients (50 of whom were men) with a mean age of 41.4\xa0±\xa012.5\xa0years were included', 'simple anal fistula', 'Adult patients with simple anal fistula who underwent anal fistulotomy']","['topical phenytoin 2% powder spray', 'topical phenytoin']","['duration to complete wound healing', 'healing of the anal wound following fistulotomy', 'postoperative pain, complications, time to return to work and impact on lifestyle', 'pain scores', 'wound healing', 'wound healing, relieve postoperative pain', 'time to complete wound healing', 'postoperative complications or impact on lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0193042', 'cui_str': 'Incision of anal fistula (procedure)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0991579', 'cui_str': 'Powder Spray'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",60.0,0.077507,"The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sanad', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Emile', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Thabet', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellaithy', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14580']
1307,30738708,"Re: Timu J. Murtola, Hemo Syvälä, Teemu Tolonen, et al. Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial. Eur Urol 2018;74:697-701.",,2019,,['Prostate Cancer'],"['Placebo', 'Atorvastatin Versus Placebo']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",[],,0.311716,,"[{'ForeName': 'Jae Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Stanford University Medical Center, CA, USA; Department of Urology, Soonchunhyang University Hospital, Soonchuhyang University Medical College, Seoul, South Korea. Electronic address: piacekjh@hanmail.net.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Stanford University Medical Center, CA, USA.'}]",European urology,['10.1016/j.eururo.2019.01.042']
1308,30730476,"Analgesic Potentials of Preoperative Oral Pregabalin, Intravenous Magnesium Sulfate, and their Combination in Acute Postthoracotomy Pain.","OBJECTIVES


The objective of this study was to investigate the effects of the preoperative combination of oral Pregabalin and intravenous (IV) magnesium sulfate as analgesic adjuvants in postthoracotomy pain.
PATIENTS AND METHODS


One hundred twenty patients with American Society of Anesthesiologists physical status II were allocated randomly into 1 of 4 groups. Group MP received 300 mg pregabalin orally and an IV infusion of magnesium sulfate 50 mg/kg mixed with 200 mL normal saline (NS); group P received 300 mg pregabalin orally and 200 mL NS infusion; group M received an IV infusion of magnesium sulfate 50 mg/kg mixed with 200 mL NS and a placebo capsule; and group C received placebo capsule and an IV infusion of 200 mL NS. All medications were given 1 hour before surgery in all groups. In the first 24 hours postoperatively, total morphine consumption, the Visual Analog Scale (0 to 10)-used as a pain measurement tool-and postoperative nausea and vomiting were assessed.
RESULTS


The total morphine consumption in the first 24 hours postoperatively decreased significantly in group MP (28.47±5.76 mg) compared with group P (33.97±6.34 mg), group M (40.87±4.4 mg), and group C (42.2±6.1 mg), respectively. VAS scores were in the accepted range (≤4) in the 4 groups throughout the first 24 hours, as all patients were on patient-controlled analgesia. However, there was a statistically significant difference at 0 and 4 hours postoperatively in favor of groups MP and P. Postoperative nausea and vomiting decreased significantly in groups MP, P, and M in comparison with group C (P<0.001).
CONCLUSIONS


The combined preoperative single dose of pregabalin and magnesium sulfate is an effective method for attenuating postoperative pain and total morphine consumption in patients undergoing thoracotomy.",2019,"The total morphine consumption in the first 24 hours postoperatively decreased significantly in group MP (28.47±5.76 mg) compared with group P (33.97±6.34 mg), group M (40.87±4.4 mg), and group C (42.2±6.1 mg), respectively.","['Acute Postthoracotomy Pain', 'patients undergoing thoracotomy', 'One hundred twenty patients with American Society of Anesthesiologists physical status II']","['placebo capsule and an IV infusion of 200\u2009mL NS', 'Preoperative Oral Pregabalin, Intravenous Magnesium Sulfate, and their Combination', 'magnesium sulfate 50\u2009mg/kg mixed with 200\u2009mL normal saline (NS); group P received 300\u2009mg pregabalin orally and 200\u2009mL NS infusion; group M received an IV infusion of magnesium sulfate 50\u2009mg/kg mixed with 200\u2009mL NS and a placebo capsule', 'pregabalin', 'oral Pregabalin and intravenous (IV) magnesium sulfate', 'pregabalin and magnesium sulfate']","['P. Postoperative nausea and vomiting', 'postoperative pain and total morphine consumption', 'total morphine consumption, the Visual Analog Scale (0 to 10)-used as a pain measurement tool-and postoperative nausea and vomiting', 'VAS scores', 'total morphine consumption']","[{'cui': 'C2732433', 'cui_str': 'Acute postthoracotomy pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.115785,"The total morphine consumption in the first 24 hours postoperatively decreased significantly in group MP (28.47±5.76 mg) compared with group P (33.97±6.34 mg), group M (40.87±4.4 mg), and group C (42.2±6.1 mg), respectively.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Salah Abdelgalil', 'Affiliation': 'Department of Anesthesiology and Pain Relief, National Cancer Institute, Cairo University, Cairo.'}, {'ForeName': 'Aktham A', 'Initials': 'AA', 'LastName': 'Shoukry', 'Affiliation': 'Department of Anesthesia, ICU, and Pain Management, Faculty of Medicine, Ain Shams University, El rehab city, Egypt.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Kamel', 'Affiliation': 'Department of Anesthesiology and Pain Relief, National Cancer Institute, Cairo University, Cairo.'}, {'ForeName': 'Ashraf M Y', 'Initials': 'AMY', 'LastName': 'Heikal', 'Affiliation': 'Department of Anesthesiology and Pain Relief, National Cancer Institute, Cairo University, Cairo.'}, {'ForeName': 'Naglaa A', 'Initials': 'NA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesiology and Pain Relief, National Cancer Institute, Cairo University, Cairo.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000673']
1309,30740858,New modes of continuous renal replacement therapy using a refiltering technique to reduce micronutrient loss.,"INTRODUCTION


Micronutrient depletion is a major drawback of high-dose continuous renal replacement therapy (CRRT). We tested two novel CRRT modes, double-filtration hemofiltration (DHF) and dialysate-recycling hemodiafiltration (DHDF), aimed at reducing micronutrient loss while maintaining a high clearance rate of midsized solutes comparable to that of high-volume hemofiltration (HVHF).
METHODS


Forty patients with renal failure requiring CRRT were randomly assigned to receive predilutional standard-volume hemofiltration (SVHF, effluent rate 35 mL/kg/h), predilutional HVHF (100 mL/kg/h), DHF (35 mL/kg/h), and DHDF (30 mL/kg/h). In the two novel modes of CRRT, part of the high-volume primary effluent fluid produced by a high-flux filter (AV600S) was refiltered by two low-flux filters (15 L) for recycling as replacement fluid in DHF and dialysate in DHDF, while the remainder was discarded as final effluent fluid. Specimens were collected for measurement of trace elements, folic acid, amino acids (AAs), β2-microglobulin, cystatin C, and creatinine and for calculation of solute clearance.
FINDINGS


The clearance of 17 AAs, phosphorus, folic acid, copper, and zinc by DHF and DHDF was much lower than that by HVHF and comparable to that by SVHF. The estimated amount of AA loss by SVHF, HVHF, DHF, and DHDF was 10.3 (7.2-13.4) g/d, 22.1 (17.8-24.0) g/d, 10.6 (8.6-14.0) g/d, and 10.0 (8.6-11.4) g/d, respectively. Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
DISCUSSION


Compared to HVHF, DHF, and DHDF have an equal capacity for removal of large solutes but show substantially reduced micronutrient loss.",2019,"Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
",['Forty patients with renal failure requiring CRRT'],"['predilutional standard-volume hemofiltration (SVHF, effluent rate 35 mL/kg/h), predilutional HVHF', 'high-volume hemofiltration (HVHF', 'double-filtration hemofiltration (DHF) and dialysate-recycling hemodiafiltration (DHDF', 'DHF']","['clearance of 17 AAs, phosphorus, folic acid, copper, and zinc by DHF and DHDF', 'trace elements, folic acid, amino acids (AAs), β2-microglobulin, cystatin C, and creatinine and for calculation of solute clearance', 'AA loss by SVHF, HVHF, DHF, and DHDF', 'Clearance of cystatin C and β2-microglobulin by DHF and DHDF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0040577', 'cui_str': 'Trace Elements'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",40.0,0.0684729,"Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
","[{'ForeName': 'Buyun', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Daxi', 'Initials': 'D', 'LastName': 'Ji', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12709']
1310,31686255,High-power therapeutic ultrasound for treatment of abdominal localized adiposity-double-blind randomized clinical trial.,"This study aimed to evaluate the effects of high-power therapeutic ultrasound in the treatment of abdominal localized adiposity in an isolated manner, with the use of neutral gel comparing ultrasonic application with 5% lipolytic active caffeine gel (phonophoresis). A total of 90 healthy women aged between 18 and 40 years were randomized and divided into two groups. The volunteers underwent anamnesis evaluation, perimetry, bioimpedance, ultrasound examination, and blood tests (complete lipidogram, creatinine, and vitamin D) before and after the end of the 10-session ultrasound protocol (3 MHz, 2 W/cm 2 , and 30w). Comparisons between groups and pre-post evaluation were performed by a two-way repeated-measures analysis of variance. Values of p < 0.05 indicated statistical significance. The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001). The examinations exhibited a significant alteration only of the complete lipidogram, but without significance (p > 0.05). When comparing the groups, no statistically significant difference was identified in any of the analyzed parameters. The high-power ultrasonic therapy is efficient in reducing localized adiposity, regardless of whether it is applied with neutral gel or 5% caffeine gel.",2020,"The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001).",['90 healthy women aged between 18 and 40 years'],"['neutral gel comparing ultrasonic application with 5% lipolytic active caffeine gel (phonophoresis', 'high-power therapeutic ultrasound', 'High-power therapeutic ultrasound']","['perimetry, bioimpedance, ultrasound examination, and blood tests (complete lipidogram, creatinine, and vitamin D', 'adipose tissue thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}]","[{'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",90.0,0.0472504,"The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001).","[{'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'da Silva Siqueira', 'Affiliation': 'Graduate Program in Electrical and Computer Engineering (CPGEI), Federal University of Technology Paraná (UTFPR), Curitiba, PR, Brazil. karinasiqueirafisio@gmail.com.'}, {'ForeName': 'Joaquim Miguel', 'Initials': 'JM', 'LastName': 'Maia', 'Affiliation': 'Electronics Engineering Department (DAELN) and Graduate Program in Electrical and Computer Engineering (CPGEI), Federal University of Technology Paraná (UTFPR), Curitiba, PR, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02895-1']
1311,30718802,"Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial.","The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI -0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597).",2019,"No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively;","['myeloma', '94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT']","['haematopoietic stem cell transplantation (HSCT', 'oral mucosa (cryotherapy', 'cryotherapy', 'Cryotherapy', 'melphalan and autologous stem cell transplantation']","['WHO scale', 'Oral mucositis']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026639', 'cui_str': 'Oral Mucosa'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0222045'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",94.0,0.0395796,"No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively;","[{'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Johansson', 'Affiliation': 'Department of Haematology, Sahlgrenska University Hospital, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden. jan-erik.j.johansson@vgregion.se.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bratel', 'Affiliation': 'Specialist clinic for Hospital Dentistry/Oral Medicine, Göteborg, Public Dental Service, Region Västra Götaland, Göteborg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hardling', 'Affiliation': 'Department of Haematology, Uddevalla Hospital, Uddevalla, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Heikki', 'Affiliation': 'Specialist Clinic for Hospital Dentistry, South Älvsborg Hospital, Borås, Sweden.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Haematology, South Älvsborg Hospital, Borås, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hasséus', 'Affiliation': 'Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.'}]",Bone marrow transplantation,['10.1038/s41409-019-0468-6']
1312,30654026,An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial.,"BACKGROUND


The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles.
METHODS


This multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California. Akin to a Multiphase Optimization Strategy (MOST) design evaluating multicomponent behavioral interventions, we will compare the combination of an app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention arms. The primary outcome is mean change in zBMI and %BMI p95  over 18 months. We hypothesize that youth who receive App+Coach will have a greater reduction in body weight over the 18-month study period at a lower cost than standard of care models. Secondary outcomes include adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level. We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.
CONCLUSIONS


New and creative approaches are needed to address pediatric obesity. If successful, this RCT may provide an innovative and cost-effective mHealth approach, based on addiction methods, for weight loss among adolescents with overweight and obesity.",2019,"We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.
","['adolescents with obesity report food or eating addiction', '180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California', 'adolescents with overweight and obesity']","['App+Coach', 'mobile health (mHealth) weight-loss intervention', 'app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention']","['mean change in zBMI and %BMI p95', 'adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level', 'body weight']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",180.0,0.108278,"We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.
","[{'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States. Electronic address: avidmar@chla.usc.edu.""}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Research Center for Health Equity Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pretlow', 'Affiliation': 'eHealth International Inc., Seattle, WA, United States.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': ""Department of Pediatrics, Division of Endocrinology at the UCLA Children's Discovery and Innovation Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Steven Fox', 'Affiliation': 'Department of Pharmaceutical and Health Economics, School of Pharmacy of the University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.008']
1313,32407710,"The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity.
METHODS


We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976.
FINDINGS


Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight.
FUNDING


Australian National Health and Medical Research Council.",2020,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","['Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using', '14 Australian and two New Zealand neonatal intensive care units', '5609 preterm infants', 'One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis', '1542 infants; 771 were assigned to the intervention group and 771 to the control group', 'very low birthweight infants (LIFT', 'Between June 27, 2014, and Sept 1, 2017']","['Lactoferrin supplements', 'lactoferrin supplementation', 'lactoferrin', ""minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age""]","['death or major morbidity', 'hospital death or major morbidity', 'fatal inspissated milk syndrome', 'unexplained late jaundice and inspissated milk syndrome', ""survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population"", 'late-onset sepsis', 'late-onset sepsis, necrotising enterocolitis, and survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5609.0,0.688179,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","[{'ForeName': 'William O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia. Electronic address: william.tarnow-mordi@ctc.usyd.edu.au.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abdel-Latif', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pammi', 'Affiliation': 'Texas Medical Centre, Houston, TX, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': 'Nuovo Ospedale Degli Infermi, Ponderano, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Ghadge', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Travadi', 'Affiliation': 'University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Darlow', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liley', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Pritchard', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': 'University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isaacs', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Askie', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Miracle Babies Foundation, Chipping Norton, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dixon', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Deshpande', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Austin', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sinn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'R John', 'Initials': 'RJ', 'LastName': 'Simes', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30093-6']
1314,30690645,Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial.,"Background


Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences.
Objective


To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control.
Design


Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061).
Setting


13 medical and surgical ICUs at 5 hospitals.
Participants


Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses.
Intervention


A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting.
Measurements


The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation.
Results


The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ.
Limitation


Contamination among clinicians could have biased results toward the null hypothesis.
Conclusion


A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making.
Primary Funding Source


National Institutes of Health.",2019,"A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes.","['277 patients, 416 surrogates, and 427 clinicians', 'Patients With Prolonged Mechanical Ventilation', 'Participants\n\n\nAdult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses']","['decision aid about prolonged mechanical ventilation', 'information according to usual care practices followed by a family meeting', 'Personalized Web-Based Decision Aid']","['decisional conflict', 'psychological distress', 'Concordance improvement', 'physician estimates', 'clinician-surrogate concordance scale', '1-year survival estimates', 'experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",277.0,0.149238,"A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Duke University, Durham, North Carolina (C.E.C., D.M.J.).'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (D.B.W., J.M.K.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'University of Washington, Seattle, Washington (C.L.H.).'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Jones', 'Affiliation': 'Duke University, Durham, North Carolina (C.E.C., D.M.J.).'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Kahn', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (D.B.W., J.M.K.).'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Duke University and the Center for Health Services Research in Primary Care at the Durham VA Medical Center, Durham, North Carolina (M.K.O.).'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado, Aurora, Colorado (C.L.L.).'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina (L.C.H., S.S.C.).'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina (L.C.H., S.S.C.).'}]",Annals of internal medicine,['10.7326/M18-2335']
1315,30229989,Prevalence and Impact of De Novo Donor-Specific Antibodies During a Multicenter Immunosuppression Withdrawal Trial in Adult Liver Transplant Recipients.,"The development of human leukocyte antigen (HLA) donor-specific antibody/antibodies (DSA) is not well described in liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA). We analyzed the development of dnDSA in 69 LT patients who received calcineurin inhibitor monotherapy and were enrolled in the ITN030ST study. Of these 69 patients, 40 stable patients were randomized to IS maintenance (n = 9) or IS minimization (n = 31). Nine of the 31 IS minimization patients achieved complete withdrawal and were free of IS. Among patients who achieved stable IS monotherapy 1 year after transplantation, the prevalence of dnDSA was 18.8%. Acute rejections and the biopsy-proven findings disqualifying patients from IS withdrawal attempt were factors associated with dnDSA development (P = 0.011 and P = 0.041, respectively). Among randomized patients, dnDSA prevalence was 51.7% after IS minimization and 66.7% in IS-free patients. dnDSA prevalence in patients on IS maintenance was 44.4%. dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015). The majority of dnDSA were against HLA-DQ antigens (78.7%). Conclusion. During the first year following transplantation, acute rejections increase the risk of developing dnDSA, so dnDSA positivity should be considered for IS withdrawal eligibility; during IS minimization, dnDSA development was associated with acute rejection, which prevented further IS withdrawal attempts.",2019,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"['Adult Liver Transplant Recipients', 'patients on', '69 LT patients who received', 'liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA', '69 patients, 40 stable patients']",['calcineurin inhibitor monotherapy'],"['dnDSA prevalence', 'complete withdrawal', 'Prevalence and Impact of De Novo Donor-Specific Antibodies', 'Acute rejections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",69.0,0.0330249,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Jucaud', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Shaked', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'DesMarais', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sayre', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Levitsky', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Everly', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30281']
1316,30713126,"Sarcopenia in adults with congenital heart disease: Nutritional status, dietary intake, and resistance training.","BACKGROUND


This study aimed (1) to assess the nutritional status and dietary intake, (2) compare the body composition and nutritional intake between sarcopenia and non-sarcopenia, and (3) evaluate the effects of resistance training and amino acid intake in adults with congenital heart disease (CHD).
METHODS


Study 1 In total, 172 adults with CHD were prospectively enrolled. The Food Frequency Questionnaire was used, and body composition analysis was conducted. Study 2: Thirty of 172 adult patients with CHD were divided into two groups: amino acid intake plus resistance training (group A) and amino acid intake only (group B) for 2 months.
RESULTS


Study 1: Skeletal muscle mass index was lower in adults with CHD compared to healthy Japanese. Calorie, protein, and fat intake in adults with CHD was higher than those in the National Nutritive Intake Investigation; however, the difference in carbohydrate or salt intake was non-significant. Study 2: In adults with CHD in group A, body fat percentage, edema index, and N-terminal prohormone of brain natriuretic peptide improved, and body weight, skeletal muscle mass index, and basic metabolism increased after the intervention. There was no improvement after intervention for group B.
CONCLUSIONS


According to this study, adults with CHD have higher calorie, protein, and fat intake than those in a national survey despite decreased skeletal muscle mass. Amino acid intake plus resistance training positively improved body fat percentage, skeletal muscle mass, and edema in adults with CHD. Appropriate nutritional education and resistance training guidelines should be provided.",2019,Skeletal muscle mass index was lower in adults with CHD compared to healthy Japanese.,"['adults with congenital heart disease', 'adults with congenital heart disease (CHD', 'adults with CHD', 'Study 2: Thirty of 172 adult patients with CHD', '172 adults with CHD were prospectively enrolled']","['resistance training and amino acid intake', 'amino acid intake plus resistance training (group A) and amino acid intake', 'Amino acid intake plus resistance training']","['body fat percentage, skeletal muscle mass, and edema', 'Calorie, protein, and fat intake', 'body fat percentage, edema index, and N-terminal prohormone of brain natriuretic peptide improved, and body weight, skeletal muscle mass index, and basic metabolism', 'Skeletal muscle mass index', 'carbohydrate or salt intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556114', 'cui_str': 'Amino acid intake (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0301817', 'cui_str': 'Hormone precursor'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]",172.0,0.0196801,Skeletal muscle mass index was lower in adults with CHD compared to healthy Japanese.,"[{'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Shiina', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan. Electronic address: yushiina@luke.ac.jp.""}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': ""Department of Nutrition, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Okamura', 'Affiliation': ""Department of Rehabilitation, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': ""Department of Rehabilitation, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Kijima', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Terunobu', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kawamatsu', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nishihata', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Komiyama', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Niwa', 'Affiliation': ""Department of Cardiology, Cardiovascular Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Journal of cardiology,['10.1016/j.jjcc.2019.01.003']
1317,30572162,Dissemination of computer-assisted cognitive-behavior therapy for depression in primary care.,"Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 240 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting in which there have been significant problems in the delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged (low-income) patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care. In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator (CC) instead of face-to-face treatment with a cognitive-behavior therapist. Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment, in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.",2019,There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients.,['240 patients randomly assigned to'],"['Computer-assisted cognitive-behavior therapy (CCBT', 'computer-assisted cognitive-behavior therapy', 'CCBT']","['CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment, in addition to ratings of depressive symptoms, negative thoughts, and quality of life']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0034380'}]",240.0,0.0353795,There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients.,"[{'ForeName': 'Becky F', 'Initials': 'BF', 'LastName': 'Antle', 'Affiliation': 'Kent School of Social Work, University of Louisville, United States. Electronic address: becky.antle@louisville.edu.'}, {'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Owen', 'Affiliation': 'Department of Counseling Psychology, Denver University, United States.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wells', 'Affiliation': 'Department of Social Work, Western Kentucky University, United States.'}, {'ForeName': 'Lesley M', 'Initials': 'LM', 'LastName': 'Harris', 'Affiliation': 'Kent School of Social Work, University of Louisville, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cappiccie', 'Affiliation': 'Department of Social Work, Western Kentucky University, United States.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Counseling Psychology, Denver University, United States.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Williams', 'Affiliation': 'Kent School of Social Work, University of Louisville, United States.'}, {'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.11.001']
1318,32407655,Methodology Matters: The Impact of Research Design on Conversational Entrainment Outcomes.,"Purpose Conversational entrainment describes the tendency for individuals to alter their communicative behaviors to more closely align with those of their conversation partner. This communication phenomenon has been widely studied, and thus, the methodologies used to examine it are diverse. Here, we summarize key differences in research design and present a test case to examine the effect of methodology on entrainment outcomes. Method Sixty neurotypical adults were randomly assigned to experimental groups formed by a 2 × 2 factorial combination of two independent variables: stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli). Individuals participated in a quasiconversational design in which the speech of a virtual interlocutor was manipulated to produce fast and slow speech rate conditions. Results There was a significant effect of stimuli organization on entrainment outcomes. Individuals in the blocked, but not the random, groups altered their speech rate to align with the speech rate of the virtual interlocutor. There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes. Conclusion Findings highlight the importance of methodological decisions on entrainment outcomes. This underscores the need for more comprehensive research regarding entrainment methodology.",2020,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"['Method Sixty neurotypical adults', 'Methodology Matters']",['stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",[],60.0,0.0260353,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"[{'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Wynn', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Borrie', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00243']
1319,30692052,Long-term effect of thymectomy plus prednisone versus prednisone alone in patients with non-thymomatous myasthenia gravis: 2-year extension of the MGTX randomised trial.,"BACKGROUND


The Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) showed that thymectomy combined with prednisone was superior to prednisone alone in improving clinical status as measured by the Quantitative Myasthenia Gravis (QMG) score in patients with generalised non-thymomatous myasthenia gravis at 3 years. We investigated the long-term effects of thymectomy up to 5 years on clinical status, medication requirements, and adverse events.
METHODS


We did a rater-blinded 2-year extension study at 36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate. MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease, and were on optimal anticholinesterase therapy with or without oral corticosteroids. In MGTX, patients were randomly assigned (1:1) to either thymectomy plus prednisone or prednisone alone. All patients in both groups received oral prednisone at doses titrated up to 100 mg on alternate days until they achieved minimal manifestation status. The primary endpoints of the extension phase were the time-weighted means of the QMG score and alternate-day prednisone dose from month 0 to month 60. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00294658. It is closed to new participants, with follow-up completed.
FINDINGS


Of the 111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group). 50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group. At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87] vs 9·34 [5·08]; p=0·0007) and mean alternate-day prednisone doses (24 mg [SD 21] vs 48 mg [29]; p=0·0002) than did those in the prednisone alone group. 14 (42%) of 33 patients in the prednisone group, and 12 (34%) of 35 in the thymectomy plus prednisone group, had at least one adverse event by month 60. No treatment-related deaths were reported during the extension phase.
INTERPRETATION


At 5 years, thymectomy plus prednisone continues to confer benefits in patients with generalised non-thymomatous myasthenia gravis compared with prednisone alone. Although caution is appropriate when generalising our findings because of the small sample size of our study, they nevertheless provide further support for the benefits of thymectomy in patients with generalised non-thymomatous myasthenia gravis.
FUNDING


National Institutes of Health, National Institute of Neurological Disorders and Stroke.",2019,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","['patients with generalised non-thymomatous myasthenia gravis at 3 years', '36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate', 'patients with non-thymomatous myasthenia gravis', 'patients with generalised non-thymomatous myasthenia gravis', ""MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease"", 'Non-Thymomatous Myasthenia Gravis Patients Receiving', '111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group', '50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group']","['anticholinesterase therapy with or without oral corticosteroids', 'thymectomy', 'Prednisone (MGTX', 'thymectomy plus prednisone', 'prednisone alone', 'thymectomy combined with prednisone', 'thymectomy plus prednisone or prednisone alone', 'prednisone', 'oral prednisone']","['time-weighted means of the QMG score', 'time-weighted mean QMG scores', 'Quantitative Myasthenia Gravis (QMG) score', 'clinical status, medication requirements, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013615', 'cui_str': 'Edrophonium'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0430810', 'cui_str': 'Repetitive nerve stimulation (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0947912'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3540712', 'cui_str': 'Anticholinesterases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.191306,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","[{'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA. Electronic address: gilwolfe@buffalo.edu.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Marx', 'Affiliation': 'Institute of Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'Institute of Pathology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mazia', 'Affiliation': 'Department of Neurology, University of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'Division of Neurology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'J Gabriel', 'Initials': 'JG', 'LastName': 'Cea', 'Affiliation': 'Department of Neurology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'Department of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'Department of Neurology, Johanes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'Department of Neurology, University of Rochester Medical Centre, Rochester, NY, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Neurology, Mental Health and Sensory Organs, University of Rome Sapienza, Rome, Italy.'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'Department of Neurology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'Department of Neurology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'Department of Neurology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Centre of Texas, Houston, TX, USA.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'Walton Centre for Neurology and Neurosurgery, Liverpool, UK.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'Unit of Neurology, Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Neurology, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Department of Neurology, Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'Department of Neurology, University of Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'Department of Neurology, Georgia Regents University, Augusta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'Department of Neurology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Neurology, University of Texas Health Science Centre, San Antonio, TX, USA.'}, {'ForeName': 'Jan J G M', 'Initials': 'JJGM', 'LastName': 'Verschuuren', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'Department of Neurology, Duke University Medical Centre, Durham, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology, Ohio State University Wexner Medical Centre, Columbus, OH, USA.'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'Department of Neurology, Universidade Federal do Parana, Curitiba, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Centre, Kansas City, KS, USA.'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'Department of Neurological Sciences, University of Vermont College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'Department of Neurology, University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Silvestri', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'Division of Extramural Research, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Jaretzki', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newsom-Davis', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30392-2']
1320,31684759,Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil.,"OBJECTIVE


Migraine displays clinical heterogeneity of attack features and attack triggers. The question is whether this heterogeneity is explained by distinct intracellular signaling pathways leading to attacks with distinct clinical features. One well-known migraine-inducing pathway is mediated by cyclic adenosine monophosphate and another by cyclic guanosine monophosphate. Calcitonin gene-related peptide triggers migraine via the cyclic adenosine monophosphate pathway and sildenafil via the cyclic guanosine monophosphate pathway. To date, no studies have examined whether migraine induction mediated via the cyclic adenosine monophosphate and cyclic guanosine monophosphate pathways yields similar attacks within the same patients.
METHODS


Patients were subjected to migraine induction on two separate days using calcitonin gene-related peptide (1.5 µg/min for 20 minutes) and sildenafil (100 mg) in a double-blind, randomized, double-dummy, cross-over design. Data on headache intensity, characteristics and accompanying symptoms were collected until 24 hours after drug administration.
RESULTS


Thirty-four patients were enrolled and 27 completed both study days. Seventeen patients developed migraine after both study drugs (63%; 95% CI: 42-81). Eight patients developed migraine on one day only (seven after sildenafil and one after calcitonin gene-related peptide). Two patients did not develop migraine on either day. Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
CONCLUSION


A majority of patients developed migraine after both calcitonin gene-related peptide and sildenafil. This supports the hypothesis that the cyclic adenosine monophosphate and cyclic guanosine monophosphate intracellular signaling pathways in migraine induction converge in a common cellular determinator, which ultimately triggers the same attacks.  Trial registration:  ClinicalTrials.gov Identifier: NCT03143465.",2019,"Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
","['Thirty-four patients were enrolled and 27 completed both study days', 'Patients were subjected to migraine induction on two separate days using']","['Calcitonin', 'calcitonin gene-related peptide (1.5\u2009µg/min for 20 minutes) and sildenafil', 'sildenafil', 'calcitonin gene-related peptide and sildenafil']","['migraine', 'Headache laterality, nausea, photophobia and phonophobia', 'headache intensity, characteristics and accompanying symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",34.0,0.145985,"Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
","[{'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Nikolaj M', 'Initials': 'NM', 'LastName': 'Toft', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Søborg', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419882474']
1321,30686542,Prospective randomised multicentre study to demonstrate the benefits of haemodialysis without acetate (with citrate): ABC-treat Study. Acute effect of citrate.,"INTRODUCTION


Dialysis fluid (DF), an essential element in hemodialysis (HD), is manufactured in situ by mixing three components: treated water, bicarbonate concentrate and acid concentrate. To avoid the precipitation of calcium and magnesium carbonate that is produced in DF by the addition of bicarbonate, it is necessary to add an acid. There are 2 acid concentrates that contain acetate (ADF) or citrate (CDF) as a stabilizer.
OBJECTIVE


To compare the acute effect of HD with CDF vs. ADF on the metabolism of calcium, phosphorus and magnesium, acid base balance, coagulation, inflammation and hemodynamic stability.
METHODS


Prospective, multicenter, randomized and crossed study, of 32 weeks duration, in patients in three-week HD, AK-200-Ultra-S or Artis monitor, 16 weeks with ADF SoftPac ® , prepared with 3mmol/L of acetate, and 16 weeks with CDF SelectBag Citrate ® , with 1mmol/L of citrate. Patients older than 18 years were included in HD for a minimum of 3 months by arteriovenous fistula. Epidemiological, dialysis, pre and postdialysis biochemistry, episodes of arterial hypotension, and coagulation scores were collected monthly during the 8 months of the study. Pre and post-dialysis analysis were extracted: venous blood gas, calcium (Ca), ionic calcium (Cai), phosphorus (P), magnesium (Mg) and parathyroid hormone (PTH) among others. ClinicalTrials.gov NCT03319680.
RESULTS


We included 56 patients, 47 (84%) men and 9 (16%) women, mean age: 65.3 (16.4) years, technique HD/HDF: 20 (35.7%)/36 (64.3%). We found differences (p<0.05) when using the DF with citrate (C) versus acetate (A) in the postdialysis values of bicarbonate [C: 26.9 (1.9) vs. A: 28.5 (3) mmol/L], Cai [C: 1.1 (0.05) vs. A: 1.2 (0.08) mmol/L], Mg [C: 1.8 (0.1) vs A: 1, 9 (0.2) mg/dL] and PTH [C: 255 (172) vs. 148 (149) pg/mL]. We did not find any differences in any of the parameters measured before dialysis. Of the 4,416 sessions performed, 2,208 in each group, 311 sessions (14.1%) with ADF and 238 (10.8%) with CDF (p<0.01), were complicated by arterial hypotension. The decrease in maximum blood volume measured by Hemoscan ®  biosensor was also lower [-3.4 (7.7) vs -5.1 (8.2)] although without statistical significance.
CONCLUSION


Dialysis with citrate acutely produces less postdialysis alkalemia and significantly modifies Ca, Mg and PTH. CDF has a positive impact on hemodynamic tolerance.",2019,"We found differences (p<0.05) when using the DF with citrate (C) versus acetate (A) in the postdialysis values of bicarbonate [C: 26.9 (1.9) vs. A: 28.5 (3) mmol/L], Cai [C: 1.1 (0.05) vs. A: 1.2 (0.08) mmol/L], Mg [C: 1.8 (0.1) vs A: 1, 9 (0.2)","['32 weeks duration, in patients in three-week HD, AK-200-Ultra-S or Artis monitor, 16 weeks with ADF SoftPac ® , prepared with 3mmol/L of acetate, and 16 weeks with', '56 patients, 47 (84%) men and 9 (16%) women, mean age: 65.3 (16.4) years, technique HD/HDF: 20 (35.7%)/36 (64.3', 'Patients older than 18 years were included in HD for a minimum of 3 months by arteriovenous fistula']","['HD with CDF vs. ADF', 'CDF', 'calcium and magnesium carbonate', 'contain acetate (ADF) or citrate (CDF', 'CDF SelectBag Citrate ® , with 1mmol/L of citrate', 'Ca, Mg and PTH', 'citrate', 'haemodialysis without acetate (with citrate): ABC', 'bicarbonate concentrate and acid concentrate']","['metabolism of calcium, phosphorus and magnesium, acid base balance, coagulation, inflammation and hemodynamic stability', 'blood gas, calcium (Ca), ionic calcium (Cai), phosphorus (P), magnesium (Mg) and parathyroid hormone (PTH', 'maximum blood volume', 'arterial hypotension', 'Epidemiological, dialysis, pre and postdialysis biochemistry, episodes of arterial hypotension, and coagulation scores', 'hemodynamic tolerance', 'postdialysis alkalemia']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0065517', 'cui_str': 'magnesium carbonate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0001117', 'cui_str': 'Acid-Base Balance'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0221106', 'cui_str': 'Alkalemia (disorder)'}]",56.0,0.0654201,"We found differences (p<0.05) when using the DF with citrate (C) versus acetate (A) in the postdialysis values of bicarbonate [C: 26.9 (1.9) vs. A: 28.5 (3) mmol/L], Cai [C: 1.1 (0.05) vs. A: 1.2 (0.08) mmol/L], Mg [C: 1.8 (0.1) vs A: 1, 9 (0.2)","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Sequera Ortiz', 'Affiliation': 'Servicio de Nefrología, Hospital Universitario Infanta Leonor, Madrid, España. Electronic address: psequerao@senefro.org.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez García', 'Affiliation': 'Servicio de Nefrología, Hospital Universitario Infanta Leonor, Madrid, España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Molina Nuñez', 'Affiliation': 'Hospital General Universitario Santa Lucía, Cartagena, España.'}, {'ForeName': 'Rosa Inés', 'Initials': 'RI', 'LastName': 'Muñoz González', 'Affiliation': 'Hospital Galdakao, Galdakao, Vizcaya, España.'}, {'ForeName': 'Gracia', 'Initials': 'G', 'LastName': 'Álvarez Fernández', 'Affiliation': 'Servicio de Nefrología, Hospital Universitario Infanta Leonor, Madrid, España.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mérida Herrero', 'Affiliation': 'Hospital Universitario Doce de Octubre, Madrid, España.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Camba Caride', 'Affiliation': 'Complexo Hospitalario Universitario Ourense, Ourense, España.'}, {'ForeName': 'Luís Alberto', 'Initials': 'LA', 'LastName': 'Blázquez Collado', 'Affiliation': 'Hospital Universitario de Guadalajara, Guadalajara, España.'}, {'ForeName': 'M Paz', 'Initials': 'MP', 'LastName': 'Alcaide Lara', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, España.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Echarri Carrillo', 'Affiliation': 'Hospital Universitario Infanta Sofía, Madrid, España.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2018.11.002']
1322,30671805,Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial.,"BACKGROUND


Hepatic parenchymal transection is the most invasive step in donor operation. During this step, blood loss and unintended injuries to the intrahepatic structures and hepatic remnant may occur. There is no evidence to prove the ideal techniques for hepatic parenchymal transection. The aim of this study is to compare the safety, efficacy, and outcome of clamp-crush technique versus harmonic scalpel as a method of parenchymal transection in living-donor hepatectomy.
METHODS


Consecutive living liver donors, undergoing right hemi-hepatectomy, during the period between May 2015 and April 2016, were included in this prospective randomized study. Cases were randomized into two groups; group (A) harmonic scalpel group and group (B) Clamp-crush group.
RESULTS


During the study period, 72 cases underwent right hemi-hepatectomy for adult living donor liver transplantation and were randomized into two groups. There were no statistically significant differences between the two groups regarding preoperative demographic and radiological data. Longer operation time and hepatectomy duration were found in group B. There were no significant differences between the two groups regarding blood loss, blood loss during hepatectomy, and blood transfusion. More unexpected bleeding events occurred in group A. Higher necrosis at the cut margin of the liver parenchyma was noted in group A. There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
CONCLUSION


Clamp-crush technique is advocated as a simple, easy, safe, and cheaper method for hepatic parenchymal transection in living donors.",2019,"There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
","['living-donor hepatectomy', 'Consecutive living liver donors, undergoing right hemi-hepatectomy, during the period between May 2015 and April 2016', '72 cases underwent right hemi-hepatectomy for adult living donor liver transplantation', 'Living Donor Hepatectomy']","['Clamp-Crush Technique Versus Harmonic Scalpel', 'clamp-crush technique versus harmonic scalpel', 'Clamp-crush technique', 'harmonic scalpel group and group (B) Clamp-crush group']","['blood loss, blood loss during hepatectomy, and blood transfusion', 'preoperative demographic and radiological data', 'Longer operation time and hepatectomy duration', 'postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates', 'bleeding events', 'safety, efficacy']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant (person)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0220947,"There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
","[{'ForeName': 'Ahmad Mohamed', 'Initials': 'AM', 'LastName': 'Sultan', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shehta', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt. ahmedshehta@mans.edu.eg.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Salah', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshoubary', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Ahmed Nabieh', 'Initials': 'AN', 'LastName': 'Elghawalby', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Said', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmorshedi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Marwan', 'Affiliation': 'Department of Hepatology, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Shiha', 'Affiliation': 'Diagnostic & Interventional Radiology Department, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Fathy', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed Abdel', 'Initials': 'MA', 'LastName': 'Wahab', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04103-5']
1323,30398407,"Decreased Thyroid Peroxidase Antibody Titer in Response to Selenium Supplementation in Autoimmune Thyroiditis and the Influence of a Selenoprotein P Gene Polymorphism: A Prospective, Multicenter Study in China.","Background:  Recent intervention studies have suggested that selenium (Se) is an effective treatment for autoimmune thyroiditis (AIT). However, the exact effect of Se on AIT is unclear as well as the mechanism of action. The aim of the present study was to explore the effect of Se on thyroid peroxidase antibody (TPOAb) titers in patients with AIT and to analyze the potential impact of the genetic background on the effect of Se supplementation.  Methods:  This was a randomized, placebo-controlled, double-blind trial. Three hundred and sixty-four patients with elevated TPOAb (>300 IU/mL) were recruited and randomized to receive Se yeast 200 μg/day supplementation or placebo. Urinary iodine concentration, serum thyrotropin, free thyroxine, TPOAb, Se, malondialdehyde, and serum glutathione peroxidase activity were measured at baseline and follow-up. Ninety-six patients were genotyped for single nucleotide polymorphism r25191G/A in the selenoprotein P ( SEPP1/SELENOP)  gene.  Results:  The median urinary iodine concentration was 182 μg/L. Serum Se increased significantly ( p  < 0.001) after Se treatment. TPOAb titer decreased by 10.0% at 3 months and by 10.7% at 6 months after Se supplementation, while there was a moderate increase in TPOAb titers over the follow-up period in patients receiving placebo. Glutathione peroxidase activity significantly increased ( p  < 0.001), and malondialdehyde significantly decreased ( p  < 0.001) after 6 months of Se supplementation. TPOAb titers decreased to variable extents in patients with different genotypes of single nucleotide polymorphism r25191G/A after Se supplementation. Serum TPOAb titers in patients with the AA genotype showed a more significant decrease (by 46.2%) than those with the GA and GG genotypes (by 14.5 and 9.8% respectively) at 3 months of Se supplementation ( p  = 0.070).  Conclusions:  Se supplementation significantly reduced TPOAb titers in patients with AIT, and there may be an important genetic component influencing interindividual differences in the decrease in TPOAb titers.",2018,TPOAb titer decreased to different extents in patients with different genotypes of SNP r25191g/a after Se supplementation.,"['SEPP Gene Polymorphism', '96 patients were genotyped for SNP r25191g/a', '364 patients with elevated TPOAb (>300 IU/mL', 'patients with AIT']","['placebo', 'Selenium Supplementation', 'Se yeast 200 μg/day supplementation or placebo']","['Urinary iodine concentration (UIC), serum thyroid-stimulating hormone (TSH), free thyroxine (FT4), TPOAb, Se, malondialdehyde (MDA), and serum glutathione peroxidase (GPX3) activity', 'thyroid peroxidase antibody', 'L. Serum Se', 'MDA', 'median UIC', 'Serum TPOAb titer', 'GPX3 activity', 'TPOAb titer']","[{'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0043393', 'cui_str': 'Yeasts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1318460', 'cui_str': 'Measurement of thyroperoxidase antibody (procedure)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",364.0,0.131945,TPOAb titer decreased to different extents in patients with different genotypes of SNP r25191g/a after Se supplementation.,"[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, ShanDong Provincial Hospital, JiNan, China.'}, {'ForeName': 'Juming', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, The General Hospital of the People's Liberation Army, Bejing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, The General Hospital of the People's Liberation Army, Bejing, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, ShanDong Provincial Hospital, JiNan, China.'}, {'ForeName': 'Mingtong', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Chenling', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Teng', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2017.0230']
1324,30169811,Can Intraindividual Variability in Cognitive Speed Be Reduced by Physical Exercise? Results From the LIFE Study.,"OBJECTIVES


Findings are mixed regarding the potential to improve older adults' cognitive ability via training and activity interventions. One novel sensitive outcome may be intraindividual variability (IIV) in cognitive speed, or moment-to-moment changes in a person's performance. The present article evaluated if participants who participated in a moderate physical activity intervention showed a reduction in IIV, compared with a successful aging education control group.
METHOD


For approximately 2.6 years, sedentary adults aged 70-90 years participated in the Lifestyle Interventions and Independence for Elders (LIFE) Study (n = 1,635), a multisite Phase 3 randomized controlled trial to reduce major mobility disability. They completed 4 reaction time tests at baseline and at approximately 24 months post-test.
RESULTS


Analyses were conducted following both the intent-to-treat principle and complier average casual effect modeling. Results indicated that participants in the physical activity group did not show a reduction in their IIV.
DISCUSSION


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample. It is also possible that other types of lifestyle activity interventions (e.g., social and cognitive engagement) can elicit reductions in IIV for older adults.",2019,"Results indicated that participants in the physical activity group did not show a reduction in their IIV.
Discussion


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample.","['For approximately 2.6 years, sedentary adults aged 70-90 years participated in the', 'participants who participated in a moderate physical activity intervention showed a reduction in IIV, compared to a successful aging education control group', 'older adults']",['Lifestyle Interventions and Independence for Elders (LIFE'],"['intraindividual variability (IIV) in cognitive speed, or moment-to-moment changes', 'major mobility disability']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",1635.0,0.0309241,"Results indicated that participants in the physical activity group did not show a reduction in their IIV.
Discussion


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample.","[{'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby101']
1325,31888977,Using Bluetooth beacon technology to reduce distracted pedestrian behaviour: a cross-over trial study protocol.,"OBJECTIVE


Over 6400 American pedestrians die annually, a figure that is currently increasing. One hypothesised reason for the increasing trend is the role of mobile technology in distracting both pedestrians and drivers. Scientists and policy-makers have attended somewhat to distracted driving, but attention to distracted pedestrian behaviour has lagged. We will evaluate Bluetooth beacon technology as a means to alert and warn pedestrians when they approach intersections, reminding them to attend to the traffic environment and cross streets safely.
METHODS


Bluetooth beacons are small devices that broadcast information unidirectionally within a closed proximal network. We will place beacons at an intersection frequently trafficked by urban college students. From there, the beacons will transmit to an app installed on users' smartphones, signalling users to attend to their environment and cross the street safely. A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus. We will monitor those participants' behaviour over three distinct time periods: (1) 3 weeks without the app being activated, (2) 3 weeks with the app activated and (3) 4 weeks without the app activated to assess retention of behaviour. Throughout the 10-week period, we will gather information to evaluate whether the intervention changes distracted pedestrian behaviour using a logistic regression to estimate the likelihood of key behavioural outcome measures and adjusting for any residual confounding. We also will test for changes in perceived risk. The trial will follow CONSORT (Consolidated Standards of Reporting Trials) statement guidelines, as modified for cross-over design studies.
CONCLUSION


If this program proves successful, it offers exciting implications for future testing and ultimately for broad distribution to reduce distracted pedestrian behavior. We discuss issues of feasibility, acceptability and scalability.",2020,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"['urban college students', '411 adults who frequently cross the target intersection on an urban university campus']",['Bluetooth beacon technology'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],411.0,0.0541355,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Ragib', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': 'Department of Computer Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043436']
1326,30689903,"Early Changes in Adipose Tissue Morphology, Gene Expression, and Metabolism After RYGB in Patients With Obesity and T2D.","CONTEXT


Roux-en-Y gastric bypass (RYGB) surgery effectively prevents or treats type 2 diabetes (T2D). Adipose tissue (AT) mechanisms may be of importance.
OBJECTIVE


To assess the relationship between early changes in whole-body and AT metabolism in surgically treated patients with T2D.
DESIGN AND SETTING


A randomized single-center study.
PATIENTS


Nineteen patients with T2D with body mass index 30 to 45 kg/m2.
INTERVENTIONS


Thirteen patients were assessed at baseline and 4 and 24 weeks after RYGB (preceded by a 4-week low-calorie diet) and compared with 6 control patients continuing standard medical treatment: oral glucose tolerance test, subcutaneous AT biopsies for gene expression, adipocyte size, glucose uptake, lipolysis, and insulin action.
RESULTS


At 4 and 24 weeks post-RYGB, all patients but one had stopped diabetes medication. Fasting glucose, HbA1c, and insulin levels decreased and the Matsuda index increased compared with baseline (P < 0.01 for all), indicating improved whole-body insulin sensitivity. Mean adipocyte size significantly reduced, more at 4 than at 24 weeks; at 4 weeks, glucose uptake per adipocyte was lowered, and isoproterenol-stimulated lipolysis tended to increase, whereas the fold insulin effects on glucose uptake and lipolysis were unchanged. Expression of genes involved in fatty acid oxidation, CPT1b and adiponectin, was increased at 4 weeks, whereas leptin and E2F1 (involved in cell proliferation) were reduced (P < 0.05 for all).
CONCLUSION


Glycemic control and in vivo insulin sensitivity improved 4 weeks after RYGB, but adipocyte insulin sensitivity did not change despite a marked reduction in adipocyte size. Thus, mechanisms for a rapid improvement of T2D after RYGB may occur mainly in other tissues than adipose.",2019,"Expression of genes involved in fatty acid oxidation, CPT1b and adiponectin, was increased at 4 weeks, whereas leptin and E2F1 (involved in cell proliferation) were reduced (P < 0.05 for all).
","['Nineteen patients with T2D with body mass index 30 to 45 kg/m2', 'surgically treated patients with T2D', 'Patients With Obesity and T2D']","['6 control patients continuing standard medical treatment: oral glucose tolerance test, subcutaneous AT biopsies']","['Mean adipocyte size', 'adipocyte insulin sensitivity', 'glucose uptake per adipocyte', 'Matsuda index', 'glucose uptake and lipolysis', 'stopped diabetes medication', 'Adipose Tissue Morphology, Gene Expression, and Metabolism', 'adipocyte size', 'leptin and E2F1', 'Expression of genes involved in fatty acid oxidation, CPT1b and adiponectin', 'Fasting glucose, HbA1c, and insulin levels']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0206131', 'cui_str': 'Fat Cells'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",13.0,0.0183662,"Expression of genes involved in fatty acid oxidation, CPT1b and adiponectin, was increased at 4 weeks, whereas leptin and E2F1 (involved in cell proliferation) were reduced (P < 0.05 for all).
","[{'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Prasad G', 'Initials': 'PG', 'LastName': 'Kamble', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gretha J', 'Initials': 'GJ', 'LastName': 'Boersma', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'F Anders', 'Initials': 'FA', 'LastName': 'Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Lundkvist', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02165']
1327,32407901,A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.,"OBJECTIVES


Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
DESIGN


This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
RESULTS


The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
CONCLUSIONS


To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005']
1328,30326151,"Differential effects of D1 and D2 dopamine agonists on memory, motivation, learning and response time in non-human primates.","Dopamine (DA) plays a critical role in cognition, motivation and information processing. DA action has been shown to both improve and/or impair cognition across different receptor types, species, subjects and tasks. This complex relationship has been described as an inverted U-shaped function and may be due to the differential effects of DA receptor activation in the striatum and prefrontal cortex. We have investigated the effects of selective DA agonists on cognitive performance in healthy monkeys using a touch screen running tasks from the CAmbridge Neuropsychological Test Automated Battery (CANTAB). One of two DA agonist drugs or placebo was administered prior to each daily CANTAB session: Dihydrexidine hydrochloride (selective D1 agonist, 0.4-0.9 mg/kg), or sumanirole maleate (selective D2 agonist 0.05-0.3 mg/kg). Three CANTAB tasks were tested: (a) ""self-ordered sequential search task"" which tested spatial working memory, (b) ""reversal learning task,"" which tested association learning, cognitive flexibility and attention and (c) ""visually guided reaching task,"" which tested reaction time and accuracy. At high dosages, the D2 agonist improved spatial working memory performance, while impairing reversal learning and slowing reach response latency. No consistent cognitive effects were observed with the D1 agonist across the dosages tested. A significant decrease in trial completion rate was observed at the higher dosages of both the D1 and D2 agonists which were consistent with decreased motivation. These results are consistent with task-specific effects of a D2 agonist as well as dose specific insensitivities of a D1 agonist on cognitive and motor behaviors in a healthy monkey.",2019,A significant decrease in trial completion rate was observed at the higher dosages of both the D1 and D2 agonists which were consistent with decreased motivation.,"['non-human primates', 'healthy monkeys using a touch screen running tasks from the CAmbridge Neuropsychological Test Automated Battery (CANTAB']","['placebo', 'D1 and D2 dopamine agonists', 'Dihydrexidine hydrochloride (selective D1 agonist, 0.4-0.9\xa0mg/kg), or sumanirole maleate (selective D2 agonist', 'self-ordered sequential search task"" which tested spatial working memory, (b) ""reversal learning task,"" which tested association learning, cognitive flexibility and attention and (c) ""visually guided reaching task,"" which tested reaction time and accuracy', 'selective DA agonists', 'Dopamine (DA']","['reversal learning and slowing reach response latency', 'memory, motivation, learning and response time', 'cognitive and motor behaviors', 'cognitive effects', 'spatial working memory performance', 'trial completion rate', 'cognitive performance']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033147', 'cui_str': 'Primates'}, {'cui': 'C0026447', 'cui_str': 'Monkeys'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}, {'cui': 'C0058038', 'cui_str': 'dihydrexidine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1312149', 'cui_str': 'Sumanirole'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0004084', 'cui_str': 'Association Learning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.0345171,A significant decrease in trial completion rate was observed at the higher dosages of both the D1 and D2 agonists which were consistent with decreased motivation.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Marino', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Levy', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.""}]",The European journal of neuroscience,['10.1111/ejn.14208']
1329,30676284,A First-in-Man Study with 4-Fluoroamphetamine Demonstrates it Produces a Mild Psychedelic State.,"The phenethylamine 4-fluoroamphetamine (4-FA) is a so-called novel psychoactive substance with a chemical structure resembling that of amphetamine and MDMA. Since 4-FA users report their subjective experience ranges between the effects induced by amphetamine and MDMA, and it is known that both substances can produce an altered state of consciousness, this study tests whether 4-FA induces a psychedelic state. A placebo-controlled two-way crossover study in 12 healthy poly-drug users was conducted to test subjective and behavioral effects of 4-FA. 4-FA concentrations were determined in serum up to 12 hours after administration and a series of questionnaires and the picture concept test were administered between one hour and 11 hours post-administration. Findings showed that 4-FA induced a psychedelic state which was highest one hour after 4-FA administration, at peak 4-FA serum concentrations. The 4-FA-induced psychedelic state decreased over time and was in general associated with the decreasing 4-FA serum concentrations. There was no 4-FA-induced change in creative (flexible) thinking. It is concluded that while the 4-FA-induced psychedelic state is mild in intensity and in between that produced by amphetamine and MDMA as hypothesized, more research is needed to indicate whether 4-FA can change creative thinking.",2019,There was no 4-FA-induced change in creative (flexible) thinking.,['12 healthy poly-drug users'],"['4-FA', 'placebo', 'amphetamine and MDMA', 'phenethylamine 4-fluoroamphetamine (4-FA', '4-Fluoroamphetamine']","['psychedelic state', '4-FA-induced change in creative (flexible) thinking', '4-FA concentrations', '4-FA serum concentrations']","[{'cui': 'C0338666', 'cui_str': 'Drug Users'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0070559', 'cui_str': 'Phenethylamine'}, {'cui': 'C0048271', 'cui_str': 'Benzeneethanamine, 4-fluoro-alpha-methyl-'}]","[{'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010297', 'cui_str': 'Creative Thinking'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",12.0,0.0167236,There was no 4-FA-induced change in creative (flexible) thinking.,"[{'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'De Sousa Fernandes Perna', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'b Department of Forensic Toxicology, Institute of Legal Medicine, Goethe University of Frankfurt , Frankfurt , Germany.'}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'a Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University , Maastricht , the Netherlands.'}]",Journal of psychoactive drugs,['10.1080/02791072.2019.1569286']
1330,30709665,"Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials.","BACKGROUND


Cadazolid is a novel quinoxolidinone antibiotic developed for treating Clostridium difficile infection. We aimed to investigate the safety and efficacy of cadazolid compared with vancomycin in patients with C difficile infection.
METHODS


IMPACT 1 and IMPACT 2 were identically designed, multicentre, double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. IMPACT 1 was done in Australia, Brazil, Canada, France, Germany, Italy, the Netherlands, Peru, Poland, Romania, Spain, and the USA, and IMPACT 2 was done in Argentina, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Greece, Hungary, Israel, Romania, Slovakia, South Korea, the UK, and the USA. Patients (aged 18 years or older) with mild-to-moderate or severe C difficile infection (diarrhoea with positive glutamate dehydrogenase and toxin A or B enzyme immunoassays) were randomly assigned (1:1) with a randomisation list stratified by centre and C difficile infection episode type (block size of four), and allocation was masked to investigators and participants. Patients received either oral cadazolid 250 mg twice daily with vancomycin-matching placebo capsule four times daily or oral vancomycin 125 mg four times a day with cadazolid-matching placebo suspension twice daily for 10 days, with 30 days of follow-up. The primary efficacy outcome was non-inferiority (margin -10%) of cadazolid versus vancomycin for clinical cure in the modified intention-to-treat and per-protocol populations. Clinical cure was defined as resolution of diarrhoea with no additional treatment for C difficile infection. These trials are registered with ClinicalTrials.gov, numbers NCT01987895 (IMPACT 1) and NCT01983683 (IMPACT 2).
FINDINGS


Between March 28, 2014, and March 24, 2017, for IMPACT 1, and Dec 13, 2013, and May 2, 2017, for IMPACT 2, 1263 participants were randomly assigned to receive cadazolid (306 in IMPACT 1 and 298 in IMPACT 2) or vancomycin (326 in IMPACT 1 and 311 in IMPACT 2). In the modified intention-to-treat population in IMPACT 1, 253 (84%) of 302 had clinical cure in the cadazolid group versus 271 (85%) of 318 in the vancomycin group. In IMPACT 2, 235 (81%) of 290 versus 258 (86%) of 301 had clinical cure. In the per-protocol population, 247 (88%) of 282 versus 264 (92%) of 288 had clinical cure in IMPACT 1 and 214 (87%) of 247 versus 237 (92%) of 259 in IMPACT 2. Non-inferiority for clinical cure to vancomycin was shown in IMPACT 1 but not in IMPACT 2 (IMPACT 1 treatment difference: -1·4 [95% CI -7·2 to 4·3] for modified intention to treat and -4·1 [-9·2 to 1·0] for per protocol; IMPACT 2: -4·7 [-10·7 to 1·3] for modified intention to treat and -4·9 [-10·4 to 0·6] for per protocol). The safety and tolerability profiles of the two antibiotics were similar.
INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials. Therefore, further commercial development of cadazolid for C difficile infection is unlikely.
FUNDING


Actelion Pharmaceuticals.",2019,"INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials.","['patients with C difficile infection', 'Patients (aged 18 years or older) with mild-to-moderate or severe C difficile infection (diarrhoea with positive glutamate dehydrogenase and toxin A or B enzyme immunoassays', '1263 participants', 'Clostridium difficile infection']","['placebo', 'modified intention to treat and -4·9', 'cadazolid', 'vancomycin', 'cadazolid versus vancomycin', 'Cadazolid', 'oral cadazolid 250 mg twice daily with vancomycin-matching placebo capsule four times daily or oral vancomycin 125 mg four times a day with cadazolid-matching placebo suspension']","['safety and efficacy', 'safety and tolerability profiles', 'resolution of diarrhoea', 'clinical cure', 'Clinical cure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0017786', 'cui_str': 'L-Glutamate:NAD+ oxidoreductase (deaminating)'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0086231', 'cui_str': 'Enzyme Immunoassay'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3885553', 'cui_str': 'cadazolid'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}, {'cui': 'C1598458', 'cui_str': 'Vancomycin 125 MG [Vancocin]'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",1263.0,0.705883,"INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials.","[{'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Edward Hines Jr Veterans Administration Hospital, Hines, IL, USA. Electronic address: dale.gerding2@va.gov.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Department of Internal Medicine, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Clinical Trials Centre Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grill', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Hilke', 'Initials': 'H', 'LastName': 'Kracker', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Marrast', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Carl Erik', 'Initials': 'CE', 'LastName': 'Nord', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': 'Talbot Advisors, Anna Maria, FL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Buitrago', 'Affiliation': 'Snake River Research, Idaho Falls, ID, USA.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Gheorghe Diaconescu', 'Affiliation': 'Victor Babes Clinical Hospital of Infectious Diseases and Pneumophysiology, Craiova, Romania.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Murta de Oliveira', 'Affiliation': 'Santa Casa de Belo Horizonte, Serviço de Controle de Infecção Hospitalar, Belo Horizonte, Brazil.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Preotescu', 'Affiliation': 'Matei Bals National Institute of Infectious Diseases, Bucharest, Romania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pullman', 'Affiliation': 'Mercury Street Medical Group, Butte, MT, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Louie', 'Affiliation': 'Foothills Medical Center, Alberta Health Services & University of Calgary, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Microbiology, Old Medical School, Leeds General Infirmary, Leeds, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30614-5']
1331,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND


The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers.
OBJECTIVE


We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT.
METHODS


We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention.
RESULTS


Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable.
CONCLUSIONS


Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512']
1332,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND


Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION


The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD


A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION


Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
1333,30487209,Effects of short-term continuous positive airway pressure withdrawal on cerebral vascular reactivity measured by blood oxygen level-dependent magnetic resonance imaging in obstructive sleep apnoea: a randomised controlled trial.,"Impaired cerebral vascular reactivity (CVR) increases long-term stroke risk. Obstructive sleep apnoea (OSA) is associated with peripheral vascular dysfunction and vascular events. The aim of this trial was to evaluate the effect of continuous positive airway pressure (CPAP) withdrawal on CVR.41 OSA patients (88% male, mean age 57±10 years) were randomised to either subtherapeutic or continuation of therapeutic CPAP. At baseline and after 2 weeks, patients underwent a sleep study and magnetic resonance imaging (MRI). CVR was estimated by quantifying the blood oxygen level-dependent (BOLD) MRI response to breathing stimuli.OSA did recur in the subtherapeutic CPAP group (mean treatment effect apnoea-hypopnoea index +38.0 events·h -1 , 95% CI 24.2-52.0; p<0.001) but remained controlled in the therapeutic group. Although there was a significant increase in blood pressure upon CPAP withdrawal (mean treatment effect +9.37 mmHg, 95% CI 1.36-17.39; p=0.023), there was no significant effect of CPAP withdrawal on CVR assessed  via  BOLD MRI under either hyperoxic or hypercapnic conditions.Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA. We thus conclude that, unlike peripheral endothelial function, CVR is not affected by short-term CPAP withdrawal.",2019,"Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA.","['obstructive sleep apnoea', 'CVR.41 OSA patients (88% male, mean age 57±10\u2005years']","['subtherapeutic CPAP', 'subtherapeutic or continuation of therapeutic CPAP', 'blood oxygen level-dependent magnetic resonance imaging', 'continuous positive airway pressure (CPAP) withdrawal', 'magnetic resonance imaging (MRI', 'short-term continuous positive airway pressure withdrawal']","['CVR', 'blood pressure upon CPAP withdrawal', 'Impaired cerebral vascular reactivity (CVR) increases long-term stroke risk', 'blood oxygen level-dependent (BOLD) MRI response to breathing stimuli', 'cerebral vascular reactivity', 'Obstructive sleep apnoea (OSA', 'OSA']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.264486,"Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA.","[{'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Lettau', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Protazy', 'Initials': 'P', 'LastName': 'Rejmer', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Haile', 'Affiliation': 'Dept of Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Esther I', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Stöberl', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boss', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Anton S', 'Initials': 'AS', 'LastName': 'Becker', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Winklhofer', 'Affiliation': 'Dept of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust and University of Oxford, Oxford, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}]",The European respiratory journal,['10.1183/13993003.01854-2018']
1334,30732940,"Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial.","BACKGROUND


Doubts exist regarding optimal second-line treatment options for HIV-1-infected patients in resource-limited settings. We assessed safety and efficacy of dolutegravir compared with ritonavir-boosted lopinavir, plus two nucleoside reverse transcriptase inhibitors (NRTIs) in adults in whom previous first-line antiretroviral therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs has failed.
METHODS


DAWNING is a phase 3b, open-label, parallel-group, non-inferiority, active-controlled trial done at 58 sites in 13 countries. Eligible adults were aged at least 18 years and, during at least 6 months of treatment with a first-line treatment containing an NNRTI and two NRTIs, had virological failure (confirmed HIV-1 RNA ≥400 copies per mL). Participants were randomly assigned by a central randomisation system to receive oral dolutegravir (50 mg once daily) or ritonavir-boosted lopinavir (800 mg lopinavir plus 200 mg ritonavir once daily or 400 mg plus 100 mg twice daily), plus two investigator-selected NRTIs (at least one fully active based on resistance testing at screening). The primary outcome was the proportion of participants achieving viral suppression (defined as plasma HIV-1 RNA <50 copies per mL) at week 48 using the snapshot algorithm and a non-inferiority margin of -12%. The primary analysis was done in an intention-to-treat-exposed (ITT-E) population of participants who received at least one dose of study medication, according to original group assignment. Safety was analysed in all participants who received at least one dose of study drug, according to which drug was received. The study was registered at ClinicalTrials.gov, number NCT02227238, and viiv-studyregister.com, number 200304.
FINDINGS


Between Dec 11, 2014, and June 27, 2016, 968 adults were screened and 627 were randomly assigned to the dolutegravir group (n=312) or the ritonavir-boosted lopinavir group (n=315). Three patients in the ritonavir-boosted lopinavir group did not receive study medication and so 624 were included in the ITT-E population. At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3). Non-inferiority was achieved on the basis of the 95% CI of the adjusted treatment difference having a lower bound greater than -12% (prespecified non-inferiority margin). Because the lower bound of the 95% CI is greater than zero (7·3%), superiority of dolutegravir was also concluded (p<0·0001). The safety profile for dolutegravir was favourable compared with that of ritonavir-boosted lopinavir. More grade 2-4 drug-related adverse events occurred with ritonavir-boosted lopinavir than dolutegravir (44 [14%] of 310 with ritonavir-boosted lopinavir vs 11 [4%] of 314 with dolutegravir), mainly driven by gastrointestinal disorders.
INTERPRETATION


When administered with two NRTIs, dolutegravir was superior to ritonavir-boosted lopinavir at 48 weeks and can be considered a suitable option for second-line treatment.
FUNDING


ViiV Healthcare.",2019,"At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3).","['adults in whom previous first-line antiretroviral therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs has failed', 'HIV-1-infected patients in resource-limited settings', '968 adults were screened and 627 were randomly assigned to the dolutegravir group (n=312) or the', 'adults with HIV-1 infection in whom first-line therapy', 'Between Dec 11, 2014, and June 27, 2016', 'Eligible adults were aged at least 18 years and, during at least 6 months of treatment with a first-line treatment containing an NNRTI and two NRTIs, had virological failure (confirmed HIV-1 RNA ≥400 copies per mL']","['oral dolutegravir', 'ritonavir-boosted lopinavir (800 mg lopinavir plus 200 mg ritonavir once daily or 400 mg plus 100 mg twice daily), plus two investigator-selected NRTIs (at least one fully active based on resistance testing at screening', 'ritonavir-boosted lopinavir', 'ritonavir-boosted lopinavir, plus two nucleoside reverse transcriptase inhibitors (NRTIs', 'Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy', 'dolutegravir']","['viral suppression', 'adverse events', 'superiority of dolutegravir', 'proportion of participants achieving viral suppression', 'Safety', 'safety profile for dolutegravir']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",968.0,0.462844,"At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lombaard', 'Affiliation': 'Josha Research, Bloemfontein, South Africa.'}, {'ForeName': 'Fujie', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Hidalgo', 'Affiliation': 'Vía Libre, Lima, Peru.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Mamedova', 'Affiliation': 'Kiev City AIDS Centre, Kiev, Ukraine.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Hospital JM Ramos Mejia, Buenos Aires, Argentina.'}, {'ForeName': 'Ploenchan', 'Initials': 'P', 'LastName': 'Chetchotisakd', 'Affiliation': 'Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brites', 'Affiliation': 'Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'ViiV Healthcare, Brentford, UK. Electronic address: jorg.x.sievers@viivhealthcare.com.'}, {'ForeName': 'Dannae', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'ViiV Healthcare, Abbotsford, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hopking', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Maria Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Punekar', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30036-2']
1335,30720560,The HIP LADIES: A Pilot Health Improvement Project for HIV Prevention in Black College Women.,"A disproportionate number of new HIV infections in the United States occur in Black women. We pilot-tested feasibility and acceptability of a manualized HIV prevention intervention developed with and for Black college women. We used a prospective, randomized 2-group design, with 3 data collection times. Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments. We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes. There were, however, no significant differences between intervention and control groups when considering motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication. We found preliminary evidence of efficacy for an HIV prevention intervention tailored to Black college women. Researchers should partner with Black college women to develop and implement HIV prevention interventions.",2019,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"['Black women', 'Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments', 'Black College Women', 'Black college women']","['manualized HIV prevention intervention', 'HIV prevention intervention']","['behavioral intentions', 'motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication', 'positive changes in HIV knowledge']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",65.0,0.0308477,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"[{'ForeName': 'Rasheeta', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Adedoyin', 'Initials': 'A', 'LastName': 'Shittu', 'Affiliation': ''}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Lescano', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Morrison-Beedy', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000058']
1336,30707787,Short-term effectiveness of platelet-rich plasma in carpal tunnel syndrome: A controlled study.,"Platelet-rich plasma (PRP) treatment has a potential to become a part of nonsurgical approach in carpal tunnel syndrome (CTS) as a regenerative method. PRP therapies aim to enhance the self-healing ability of human body, by exposing the injured tissue to a high concentration of autologous growth factors. Nerve tissues also seem to benefit from the regenerative effects of PRP concentrates. The aim of this study is to investigate the possible beneficial effects of PRP injection in CTS. A total of 40 hands of 30 patients were included (20 hands per group) with mild to moderate idiopathic CTS. Patients with mild to moderate CTS were placed into either control or PRP groups. Activity modification and night-only wrist splints were suggested in both groups. Additionally, in PRP group, a single perineural PRP injection into the carpal tunnel was applied under ultrasound guidance. Sensibility tests, Boston carpal tunnel questionnaire (BCTQ), and electrophysiological and ultrasonographical findings were measured initially and after 4 weeks. Groups were similar regarding demographics. BCTQ scores and ultrasonographical values were improved in both groups. Delta analyses revealed that the difference of BCTQ scores improved better in PRP group. Electrophysiological values improved in PRP group. Our study demonstrated that a single, perineural PRP injection into carpal tunnel provided further improvements in CTS.",2019,BCTQ scores and ultrasonographical values were improved in both groups.,"['A total of 40 hands of 30 patients were included (20 hands per group) with mild to moderate idiopathic CTS', 'Patients with mild to moderate CTS', 'carpal tunnel syndrome']","['PRP injection', 'platelet-rich plasma', 'Platelet-rich plasma (PRP']","['Sensibility tests, Boston carpal tunnel questionnaire (BCTQ), and electrophysiological and ultrasonographical findings', 'BCTQ scores and ultrasonographical values', 'Electrophysiological values', 'BCTQ scores', 'Activity modification and night-only wrist splints']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}]",30.0,0.00965874,BCTQ scores and ultrasonographical values were improved in both groups.,"[{'ForeName': 'Serdar Can', 'Initials': 'SC', 'LastName': 'Güven', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Özçakar', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}, {'ForeName': 'Bayram', 'Initials': 'B', 'LastName': 'Kaymak', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kara', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}, {'ForeName': 'Ayşen', 'Initials': 'A', 'LastName': 'Akıncı', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.2815']
1337,32407827,A simulation approach to measure critical safety behaviors when evaluating training methods for respirator education in healthcare workers.,"BACKGROUND


The N95 respirator is the most common safety tool used in hospitals to protect health care workers (HCW) from inhaling airborne particles. Focusing on HCW behavior related to respirator use is an effective route to improve HCW safety and respiratory health.
METHODS


Participants were asked to perform the donning and doffing of an N95 respirator to camera. Then they were randomized to a video alone or a reflective practice intervention. After the intervention they repeated the donning and doffing to camera. A critical safety behavior scoring tool (CSBST) was developed to compare the performance of the participants over time at pretest, post-test and 1 month later for follow-up.
RESULTS


The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group. In the reflective practice intervention group, the participants perceived they were better at performing the N95 donning and doffing than the experts scored them.
CONCLUSIONS


The CSBST is a tool to measure the performance of HCWs on a specific targeted safety behaviors. The addition of a reflective practice intervention may result in a measurable and sustained improvement in the safety behaviors demonstrated when using the N95 respirator.",2020,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"['Participants were asked to perform the donning and doffing of an N95 respirator to camera', 'hospitals to protect healthcare workers (HCW) from inhaling airborne particles', 'healthcare workers']","['video alone or a reflective practice intervention', 'CSBST']","['safety behaviors', 'HCW safety and respiratory health']","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.036832,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Beam', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE; Nebraska Biocontainment Unit, Omaha, NE. Electronic address: ebeam@unmc.edu.'}, {'ForeName': 'Jocelyn J', 'Initials': 'JJ', 'LastName': 'Herstein', 'Affiliation': 'Nebraska Biocontainment Unit, Omaha, NE; Department of Environmental, Agricultural, and Occupational Health, University of Nebraska Medical Center, College of Public Health, Omaha, NE.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Gibbs', 'Affiliation': 'Texas A & M School of Public Health, College Station, TX.'}]",American journal of infection control,['10.1016/j.ajic.2020.05.005']
1338,30688048,Comparison of the Efficacy of Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy on Lipid Parameters in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND


The apolipoprotein B/A1 (apoB/A1) ratio is a stronger predictor of future cardiovascular disease than is the level of conventional lipids. Statin and ezetimibe combination therapy have shown additional cardioprotective effects over statin monotherapy.
METHODS


This was a single-center, randomized, open-label, active-controlled study in Korea. A total of 36 patients with type 2 diabetes mellitus were randomized to either rosuvastatin monotherapy (20 mg/day,  n =20) or rosuvastatin/ezetimibe (5 mg/10 mg/day,  n =16) combination therapy for 6 weeks.
RESULTS


After the 6-week treatment, low density lipoprotein cholesterol (LDL-C) and apoB reduction were comparable between the two groups (-94.3±15.4 and -62.0±20.9 mg/dL in the rosuvastatin group, -89.9±22.7 and -66.8±21.6 mg/dL in the rosuvastatin/ezetimibe group,  P =0.54 and  P =0.86, respectively). In addition, change in apoB/A1 ratio (-0.44±0.16 in the rosuvastatin group and -0.47±0.25 in the rosuvastatin/ezetimibe group,  P =0.58) did not differ between the two groups. On the other hand, triglyceride and free fatty acid (FFA) reductions were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group (-10.5 mg/dL [interquartile range (IQR), -37.5 to 29.5] and 0.0 μEq/L [IQR, -136.8 to 146.0] in the rosuvastatin group, -49.5 mg/dL [IQR, -108.5 to -27.5] and -170.5 μEq/L [IQR, -353.0 to 0.8] in the rosuvastatin/ezetimibe group,  P =0.010 and  P =0.049, respectively). Both treatments were generally well tolerated, and there were no differences in muscle or liver enzyme elevation.
CONCLUSION


A 6-week combination therapy of low-dose rosuvastatin and ezetimibe showed LDL-C, apoB, and apoB/A1 ratio reduction comparable to that of high-dose rosuvastatin monotherapy in patients with type 2 diabetes mellitus. Triglyceride and FFA reductions were greater with the combination therapy than with rosuvastatin monotherapy.",2019,"After the 6-week treatment, low density lipoprotein cholesterol (LDL-C) and apoB reduction were comparable between the two groups (-94.3±15.4 and -62.0±20.9 mg/dL in the rosuvastatin group, -89.9±22.7 and -66.8±21.6 mg/dL in the rosuvastatin/ezetimibe group,  P =0.54 and  P =0.86, respectively).","['Patients with Type 2 Diabetes Mellitus', '36 patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus']","['rosuvastatin and ezetimibe', 'rosuvastatin/ezetimibe', 'rosuvastatin monotherapy', 'Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy', 'Statin and ezetimibe combination therapy', 'rosuvastatin']","['change in apoB/A1 ratio', 'Triglyceride and FFA reductions', 'Lipid Parameters', 'low density lipoprotein cholesterol (LDL-C) and apoB reduction', 'muscle or liver enzyme elevation', 'triglyceride and free fatty acid (FFA) reductions', 'LDL-C, apoB, and apoB/A1 ratio reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}]",36.0,0.0163156,"After the 6-week treatment, low density lipoprotein cholesterol (LDL-C) and apoB reduction were comparable between the two groups (-94.3±15.4 and -62.0±20.9 mg/dL in the rosuvastatin group, -89.9±22.7 and -66.8±21.6 mg/dL in the rosuvastatin/ezetimibe group,  P =0.54 and  P =0.86, respectively).","[{'ForeName': 'You Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea. khmcilyong@khnmc.or.kr.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Jun', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'In Kyung', 'Initials': 'IK', 'LastName': 'Jeong', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu Jeung', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ho Yeon', 'Initials': 'HY', 'LastName': 'Chung', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}]",Diabetes & metabolism journal,['10.4093/dmj.2018.0124']
1339,30376537,Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial.,"BACKGROUND


Rib fractures occur in up to 40% of trauma patients and are associated with increased mortality. Opiate-based pain regimens remain the cornerstone of rib fracture management; however, concerns around opioids have fostered interest in alternative analgesics. Ketamine is currently being used in lieu of opioids, but little evidence exists supporting its use within the trauma population.
METHODS


A prospective, randomized, double-blind placebo-controlled trial of adult patients with three or more rib fractures admitted to a Level I trauma center was conducted. Exclusion criteria included age older than 64 years, Glasgow Coma Scale score less than 13, and chronic opiate use. The experimental arm received low-dose ketamine (LDK) at 2.5 μg·kg·min while the placebo cohort received an equivalent rate of 0.9% normal saline. All infusions were continued for 48 hours. The primary outcome was reduction in numeric pain score (NPS) during the first 24 hours. Secondary outcomes studied included oral morphine equivalent (OME) utilization, length of stay, epidural rates, pulmonary complications, and adverse events.
RESULTS


Forty-five (49%) of 91 patients were randomized to the experimental arm. Both groups were similar in makeup. Overall, 74.7% were male, had a median age of 49 years, and an Injury Severity Score (ISS) of 14. Low-dose ketamine was not associated with a significant reduction in 24-hour NPS or OME totals. Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048). No difference in other secondary outcomes or adverse events was noted.
CONCLUSION


Low-dose ketamine failed to decrease NPS or OME within the overall cohort, but a decrease in OME was observed among patients with an ISS greater than 15. Confirmatory studies are necessary to determine if LDK is a useful adjunct among severely injured patients.
LEVEL OF EVIDENCE


Therapeutic study, level II.",2019,"Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048).","['adult patients with three or more rib fractures admitted to a Level I trauma center was conducted', 'adult patients with multiple rib fractures', 'Forty-five (49%) of 91 patients', 'Exclusion criteria included age older than 64 years, Glasgow Coma Scale score less than 13, and chronic opiate use', 'severely injured patients']","['Ketamine', 'ketamine', 'placebo', 'low-dose ketamine (LDK']","['numeric pain score (NPS', 'OME utilization', '24-hour NPS or OME totals', 'OME', 'adverse events', 'mortality', 'oral morphine equivalent (OME) utilization, length of stay, epidural rates, pulmonary complications, and adverse events', 'NPS or OME']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",45.0,0.398711,"Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048).","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Carver', 'Affiliation': 'From the Division of Trauma and Acute Care Surgery, Department of Surgery (T.W.C.), Division of Trauma and Acute Care Surgery, Department of Surgery (N.W.K.), Division of Critical Care Pharmacy, Department of Pharmacy (J.J.), Division of Trauma and Acute Care Surgery, Department of Surgery (W.J.P.), Division of Regional Anesthesia and Acute Pain Management, Department of Anesthesia (K.M.D.), Division of Trauma and Acute Care Surgery, Department of Surgery (L.B.S.), Division of Biostatistics (A.S., Z.Y.), and Division of General Surgery, Department of Surgery (J.S.P.), Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Kugler', 'Affiliation': ''}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Peppard', 'Affiliation': ''}, {'ForeName': 'Karin Madsen', 'Initials': 'KM', 'LastName': 'Drescher', 'Affiliation': ''}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Somberg', 'Affiliation': ''}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': ''}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Jasmeet S', 'Initials': 'JS', 'LastName': 'Paul', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002103']
1340,30683457,Effect of short-term colchicine treatment on endothelial function in patients with coronary artery disease.,"BACKGROUND


Inflammation is associated with endothelial dysfunction and plays an important role in the pathogenesis and development of cardiovascular diseases. It has been shown that colchicine, an anti-inflammatory drug, improves the cardiovascular outcome in patients with cardiovascular disease. The purpose of this study was to evaluate the short-term effect of low-dose colchicine on endothelial function in patients with coronary artery disease (CAD).
METHODS


This was a double-blind, randomized, placebo-controlled, crossover-within-subject clinical trial. A total of 28 patients with CAD received low-dose colchicine (0.5 mg/day) or a placebo for 7 days with a washout period of at least 14 days. Flow-mediated vasodilation (FMD) and serum concentrations of high-sensitivity C-reactive protein (hs-CRP) were measured after the 7-day treatment with colchicine or the placebo.
RESULTS


The serum concentration of hs-CRP was significantly decreased after administration of colchicine compared with that after administration of the placebo [median (interquartile range): 0.04 (0.02-0.08) mg/dL vs. 0.07 (0.04-0.11) mg/dL, P = 0.003], while there was no significant difference in FMD between the treatments [median (interquartile range): 3.1% (1.5-5.3%) vs. 3.3% (1.9-5.2%), P = 0.384]. Colchicine, however, significantly improved FMD in coronary artery disease patients with white blood cell (WBC) counts of ≥7500 WBC/mm 3  [median (interquartile range): 3.3% (2.1-6.6%) vs. 2.0% (1.4-3.8%), P = 0.043].
CONCLUSIONS


Administration of low-dose colchicine did not improve endothelial function in patients with CAD, but exploratory analysis suggested that endothelial function is significantly improved in patients with leukocyte activation.",2019,"The serum concentration of hs-CRP was significantly decreased after administration of colchicine compared with that after administration of the placebo [median (interquartile range): 0.04 (0.02-0.08) mg/dL vs. 0.07 (0.04-0.11) mg/dL, P = 0.003], while there was no significant difference in FMD between the treatments [median (interquartile range): 3.1% (1.5-5.3%) vs. 3.3% (1.9-5.2%), P = 0.384].","['28 patients with CAD', 'patients with coronary artery disease (CAD', 'patients with coronary artery disease', 'patients with CAD', 'patients with cardiovascular disease']","['short-term colchicine', 'placebo', 'Colchicine', 'low-dose colchicine', 'colchicine']","['Flow-mediated vasodilation (FMD) and serum concentrations of high-sensitivity C-reactive protein (hs-CRP', 'serum concentration of hs-CRP', 'endothelial function', 'FMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",28.0,0.512436,"The serum concentration of hs-CRP was significantly decreased after administration of colchicine compared with that after administration of the placebo [median (interquartile range): 0.04 (0.02-0.08) mg/dL vs. 0.07 (0.04-0.11) mg/dL, P = 0.003], while there was no significant difference in FMD between the treatments [median (interquartile range): 3.1% (1.5-5.3%) vs. 3.3% (1.9-5.2%), P = 0.384].","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kajikawa', 'Affiliation': 'Division of Regeneration and Medicine, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Division of Regeneration and Medicine, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan; Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan. Electronic address: yhigashi@hiroshima-u.ac.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Maruhashi', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kurisu', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Kihara', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Mutoh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan. Electronic address: blessyou@med.u-ryukyu.ac.jp.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.01.054']
1341,30872116,"Loss of bronchoprotection with ICS plus LABA treatment, β-receptor dynamics, and the effect of alendronate.","BACKGROUND


Loss of bronchoprotection (LOBP) with a regularly used long-acting β 2 -adrenergic receptor agonist (LABA) is well documented. LOBP has been attributed to β 2 -adrenergic receptor (B2AR) downregulation, a process requiring farnesylation, which is inhibited by alendronate.
OBJECTIVE


We sought to determine whether alendronate can reduce LABA-associated LOBP in inhaled corticosteroid (ICS)-treated patients.
METHODS


We conducted a randomized, double-blind, placebo-controlled, parallel-design, proof-of-concept trial. Seventy-eight participants with persistent asthma receiving 250 μg of fluticasone twice daily for 2 weeks were randomized to receive alendronate or placebo while initiating salmeterol for 8 weeks. Salmeterol-protected methacholine challenges (SPMChs) and PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP ELISA) were assessed before randomization and after 8 weeks of ICS plus LABA treatment. LOBP was defined as a more than 1 doubling dose reduction in SPMCh PC 20  value.
RESULTS


The mean doubling dose reduction in SPMCh PC 20  value was 0.50 and 0.27 with alendronate and placebo, respectively (P = .62). Thirty-eight percent of participants receiving alendronate and 33% receiving placebo had LOBP (P = .81). The after/before ICS plus LABA treatment ratio of B2AR number was 1.0 for alendronate (P = .86) and 0.8 for placebo (P = .15; P = .31 for difference between treatments). The B2AR signaling ratio was 0.89 for alendronate (P = .43) and 1.02 for placebo (P = .84; P = .44 for difference). Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
CONCLUSION


This study did not find evidence that alendronate reduces LABA-associated LOBP, which relates to the occurrence of LOBP in only one third of participants. LOBP appears to be less common than presumed in concomitant ICS plus LABA-treated asthmatic patients. B2AR downregulation measured in PBMCs does not appear to reflect LOBP.",2019,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","['Seventy-eight participants with persistent asthma receiving 250\xa0μg of', 'twice daily for 2\xa0weeks', 'inhaled corticosteroid (ICS)-treated patients']","['salmeterol', 'placebo', 'fluticasone', 'alendronate or placebo', 'LOBP', 'Salmeterol-protected methacholine', 'alendronate']","['PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP', 'B2AR number', 'ELISA', 'B2AR downregulation measured in PBMCs', 'lung function and B2AR number and signaling', 'B2AR signaling ratio', 'LOBP']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",78.0,0.67113,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Gerard', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McIntire', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Homer A', 'Initials': 'HA', 'LastName': 'Boushey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Codispoti', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moy', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Solway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish University, Denver, Colo.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: eisrael@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.049']
1342,30463423,The Safety and Efficacy of Expiratory Muscle Strength Training for Rehabilitation After Supracricoid Partial Laryngectomy: A Pilot Investigation.,"OBJECTIVES


Expiratory muscle strength training (EMST) is a safe, effective intervention that can be performed at home and may be beneficial for individuals with voice and swallowing disorders. To date there have been few studies of EMST in the head and neck cancer population, and there are no previous reports of its use after supracricoid partial laryngectomy (SCPL). The current prospective clinical pilot study was undertaken to determine the safety and efficacy of a 4-week treatment program.
METHODS


Six participants were recruited who had previously undergone SCPL, were medically stable, and had no contraindications for use of the device. At baseline, objective respiratory measurements were collected, dietary status was recorded, and participants were asked to complete a series of validated self-report instruments relating to voice, swallowing, breathing, and cough. Following the completion of treatment, baseline measures were repeated, and participant feedback was solicited.
RESULTS


The majority of individuals found the device easy to use (83%) and beneficial (83%). The side effects of treatment were relatively minor and included dizziness, muscle inflammation, and vocal fatigue. There were improvements in 2 measures from before to after treatment, namely, an average 21% increase in peak cough flow (from 371.67 to 451.33 L/min) and a 38% decrease on the Dyspnea Index (from 6.17 to 3.83). Other measures showed inconsistent changes.
CONCLUSIONS


EMST appeared to improve cough strength and reduce dyspnea symptoms after SCPL. Further study of the relative efficacy of EMST compared to other rehabilitation protocols after SCPL is needed.",2019,"is a safe, effective intervention that can be performed at home and may be beneficial for individuals with voice and swallowing disorders.","['individuals with voice and swallowing disorders', 'Six participants were recruited who had previously undergone SCPL, were medically stable, and had no contraindications for use of the device']","['Expiratory muscle strength training (EMST', 'EMST', 'Expiratory Muscle Strength Training for Rehabilitation', 'Supracricoid Partial Laryngectomy', 'supracricoid partial laryngectomy (SCPL']","['safety and efficacy', 'Dyspnea Index', 'dizziness, muscle inflammation, and vocal fatigue', 'validated self-report instruments relating to voice, swallowing, breathing, and cough', 'cough strength and reduce dyspnea symptoms', 'peak cough flow']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0189234', 'cui_str': 'Partial laryngectomy (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027121', 'cui_str': 'Inflammatory Myopathy'}, {'cui': 'C0241700', 'cui_str': 'Voice Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C4708767', 'cui_str': 'Strength of cough (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",6.0,0.0196321,"is a safe, effective intervention that can be performed at home and may be beneficial for individuals with voice and swallowing disorders.","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Palmer', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Bolognone', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Skipp', 'Initials': 'S', 'LastName': 'Thomsen', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Britton', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Schindler', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Graville', 'Affiliation': 'Northwest Center for Voice and Swallowing, Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland, OR, USA.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489418812901']
1343,30769088,Multi-pronged intervention to increase secondary student participation in school lunch: Design and rationale.,"BACKGROUND


In the United States, the National School Lunch Program (NSLP) is the healthiest lunch option for students, yet participation is suboptimal and fruit and vegetable waste remains high. Improving school meal convenience, engaging teachers in the school-lunch program, and enhancing the cafeteria environment are promising strategies to improve participation and dietary intake, yet little evidence is available on their impact.
METHODS/DESIGN


The Multi-Pronged Intervention to Increase Secondary Student Participation in School Lunch (MPI) is a 3-year quasi-experimental study in a large urban school district in California. A total of 24 middle and high schools participated in the study: half received the intervention and half served as controls. The intervention consisted of additional school lunch points of sale (vending machines and mobile carts), a school meal outreach program for teachers, and cafeteria redesigns. School meal participation, student-reported fruit and vegetable consumption, and school lunch plate waste were assessed at baseline and in years 1 and 2 of the intervention. Change in meal participation and fruit and vegetable consumption were compared between intervention and control arms to determine the impact of the intervention on school meal participation and dietary intake.
DISCUSSION


This study is positioned to provide evidence on the feasibility and efficacy of a multi-level intervention to increase school meal participation and consumption of fruits and vegetables.",2019,"Change in meal participation and fruit and vegetable consumption were compared between intervention and control arms to determine the impact of the intervention on school meal participation and dietary intake.
","['school lunch', 'A total of 24 middle and high schools participated in the study: half received the intervention and half served as controls', 'large urban school district in California']","['additional school lunch points of sale (vending machines and mobile carts), a school meal outreach program for teachers, and cafeteria redesigns', 'multi-level intervention', 'Multi-Pronged Intervention to Increase Secondary Student Participation in School Lunch (MPI', 'Multi-pronged intervention']","['school meal participation and consumption of fruits and vegetables', 'Change in meal participation and fruit and vegetable consumption', 'School meal participation, student-reported fruit and vegetable consumption, and school lunch plate waste']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}]",24.0,0.0147937,"Change in meal participation and fruit and vegetable consumption were compared between intervention and control arms to determine the impact of the intervention on school meal participation and dietary intake.
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Lorrene', 'Initials': 'L', 'LastName': 'Ritchie', 'Affiliation': 'University of California, Division of Agriculture and Natural Resources, Nutrition Policy Institute, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Thompson', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Reed', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Ana Ibarra', 'Initials': 'AI', 'LastName': 'Castro', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Neelon', 'Affiliation': 'University of California, Division of Agriculture and Natural Resources, Cooperative Extension, United States.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Madsen', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: madsenk@berkeley.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.013']
1344,30659292,Evaluation of the effects of antioxidant treatment on sperm parameters and pregnancy rates in infertile patients after varicocelectomy: a randomized controlled trial.,"In this study, we aimed to evaluate the effect of oral antioxidant treatment on semen parameters and pregnancy rates in infertile men who underwent varicocelectomy. The study was conducted between January 2016 and January 2018. Subinguinal microscopic varicocelectomy was performed in 90 patients who were referred for infertility and diagnosed with clinical varicocele. The patients were divided into two groups. The first group received antioxidant treatment for 6 months after the operation (n = 62); the second group did not receive treatment after the operation (n = 28). The semen analysis was performed at the time of diagnosis and at 6 months postoperatively. The postoperative treatment semen parameters and pregnancy rates between the two groups were compared. The improvement in total sperm count ( + 45.9% vs + 26.8%), total motile sperm count ( + 50.6% vs + 29.7%), sperm concentration ( + 71.4% vs + 54.5%), sperm count in normal morphology ( + 75.7% vs + 39.9%), and total ( + 28.6% vs + 18.3%) and progressive motile sperm count ( + 60.4% vs + 38.9%) were significantly higher in the treated group than in the untreated group (p = 0.011, p < 0.001, p = 0.008, p < 0.001, p = 0.024 and p < 0.001, respectively). The clinical pregnancy rate in the first group was significantly higher than that in the second group (29% vs 17.9%) (p = 0.029). We concluded that the antioxidant treatment provides an important contribution to varicocelectomy outcomes and improves pregnancy rates.",2019,"The improvement in total sperm count ( + 45.9% vs + 26.8%), total motile sperm count ( + 50.6% vs + 29.7%), sperm concentration ( + 71.4% vs + 54.5%), sperm count in normal morphology ( + 75.7% vs + 39.9%), and total ( + 28.6% vs + 18.3%) and progressive motile sperm count ( + 60.4% vs + 38.9%) were significantly higher in the treated group than in the untreated group (p = 0.011, p < 0.001, p = 0.008, p < 0.001, p = 0.024 and p < 0.001, respectively).","['January 2016 and January 2018', 'infertile men who underwent varicocelectomy', '90 patients who were referred for infertility and diagnosed with clinical varicocele', 'infertile patients after varicocelectomy']","['Subinguinal microscopic varicocelectomy', 'oral antioxidant treatment', 'antioxidant treatment']","['sperm parameters and pregnancy rates', 'total motile sperm count', 'clinical pregnancy rate', 'sperm count in normal morphology', 'progressive motile sperm count', 'sperm concentration', 'pregnancy rates', 'total sperm count', 'semen parameters and pregnancy rates']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037842', 'cui_str': 'Sperm Count'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C0429846', 'cui_str': 'Sperm total count procedure'}]",90.0,0.0375715,"The improvement in total sperm count ( + 45.9% vs + 26.8%), total motile sperm count ( + 50.6% vs + 29.7%), sperm concentration ( + 71.4% vs + 54.5%), sperm count in normal morphology ( + 75.7% vs + 39.9%), and total ( + 28.6% vs + 18.3%) and progressive motile sperm count ( + 60.4% vs + 38.9%) were significantly higher in the treated group than in the untreated group (p = 0.011, p < 0.001, p = 0.008, p < 0.001, p = 0.024 and p < 0.001, respectively).","[{'ForeName': 'Fuat', 'Initials': 'F', 'LastName': 'Kızılay', 'Affiliation': 'Department of Urology, Ege University School of Medicine, İzmir, Turkey. fuatkizilay@gmail.com.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Altay', 'Affiliation': 'Department of Urology, Ege University School of Medicine, İzmir, Turkey.'}]",International journal of impotence research,['10.1038/s41443-018-0109-4']
1345,31681964,"Patient selection, pacing indications, and subsequent outcomes with de novo leadless single-chamber VVI pacing.","AIMS


Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial.
METHODS AND RESULTS


The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59).
CONCLUSION


Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF.",2019,Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001).,"['720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group', 'Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial']",['Micra VVI therapy'],"['AF or history of AF', 'overall occurrence of the composite outcome', 'ventricular pacing', 'transvenous pacemaker', 'cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure']","[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C4708784', 'cui_str': '31.7 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus (organism)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0340929', 'cui_str': 'Cardiac pacemaker syndrome (disorder)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",720.0,0.0311939,Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001).,"[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Electrophysiology Section, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Stromberg', 'Affiliation': 'Medtronic plc, Mounds View, MN, USA.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jackson', 'Affiliation': 'Electrophysiology Section, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Kowal', 'Affiliation': 'Medtronic plc, Mounds View, MN, USA.'}, {'ForeName': 'Gabor Z', 'Initials': 'GZ', 'LastName': 'Duray', 'Affiliation': 'Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Mikhael F', 'Initials': 'MF', 'LastName': 'El-Chami', 'Affiliation': 'Emory University Hospital, Atlanta, GA, USA.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Crossley', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hummel', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Calambur', 'Initials': 'C', 'LastName': 'Narasimhan', 'Affiliation': 'CARE Hospitals and CARE Foundation, Hyderabad, India.'}, {'ForeName': 'Razali', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ritter', 'Affiliation': 'Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Roberts', 'Affiliation': 'University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Kyorin University Hospital, Tokyo, Japan.'}, {'ForeName': 'Dwight', 'Initials': 'D', 'LastName': 'Reynolds', 'Affiliation': 'Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, Beijing, China.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Steinwender', 'Affiliation': 'Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Chinitz', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz230']
1346,32408245,"The impact of a three-phase video-assisted debriefing on nursing students' debriefing experiences, perceived stress and facilitators' practices: A mixed methods study.","BACKGROUND


As an integral part of simulation, debriefing helps learners to construct knowledge through reflecting, internalizing, and relating. Video-assisted debriefing (VAD) adds audio-visual captures and reviews to support traditional verbal debriefing (VD), but evidence evaluating its educational effects has been mixed, with limited attention focusing on its structure development.
AIMS


This study aimed to 1) investigate the effects of a three-phase VAD in enhancing nursing students' debriefing experiences and perceived stress compared to VD and 2) to explore its impact on facilitators' debriefing practices.
METHODS


A mixed-methods design was adopted. The quantitative phase involved a prospective controlled trial on 145 nursing students from a university in Singapore who were randomized into the intervention cluster (n = 72) and the control cluster (n = 73). The debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version) were used as outcome measures. For the qualitative component, a purposive sample of eight facilitators evaluated their own debriefing practices using the DASH© instructor version and each completed an open-ended question survey. Qualitative data were analyzed using content analysis.
RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster. Repeated VAD significantly reduced students' stress (p < 0.001). Students viewed the VAD facilitators as more effective than the VD facilitators. Three categories were derived from the qualitative comments: the act of debriefing, the crux of VAD, and debriefing for success.
CONCLUSION


The three-phase VAD significantly improved nursing students' debriefing experiences without adding extra stress. It also helped to improve facilitators' practices. Future research will benefit from exploring how experts facilitate the three-phase VAD ""on the ground"" and its effect on learning transfer and cost-effectiveness.",2020,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.",['145 nursing students from a university in Singapore who were randomized into the intervention cluster (n\xa0=\xa072) and the control cluster (n\xa0=\xa073'],"['Video-assisted debriefing (VAD', 'three-phase video-assisted debriefing']","[""impressions of VAD facilitators' practices"", 'debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version', 'debriefing experiences']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",145.0,0.0300089,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurzh@nus.edu.sg.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurww@nus.edu.sg.'}, {'ForeName': 'S H L', 'Initials': 'SHL', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurghs@nus.edu.sg.'}, {'ForeName': 'X V', 'Initials': 'XV', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurwux@nus.edu.sg.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia. Electronic address: e.morelius@ecu.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104460']
1347,30688550,Even Short-Term Telmisartan Treatment Ameliorated Insulin Resistance But Had No Influence on Serum Adiponectin and Tumor Necrosis Factor-Alpha Levels in Hypertensive Patients with Metabolic Syndrome.,"BACKGROUND


We investigated the effect of short-term telmisartan usage in addition to lifestyle changes such as diet and exercise on insulin resistance, lipid metabolism, and serum adiponectin and tumor necrosis factor-alpha (TNF-α) levels in hypertensive patients with metabolic syndrome (MetS).
METHODS


A total of 36 hypertensive patients with MetS were randomized to telmisartan and control groups in an open-labeled prospective study.
RESULTS


There were significant decreases in anthropometric variables of patients according to baseline measurements in both groups at the end of the study. Serum insulin level and insulin resistance assessed by homeostasis model assessment-insulin resistance were decreased significantly in the telmisartan group (P = 0.040 and P = 0.034, respectively) compared with the controls, while there was no statistically significant change in the lipid profiles of the two groups. Serum adiponectin level was increased by 19.1% ± 41.7% in the telmisartan group, but intergroup analysis revealed no significant change. There was also no significant change in serum TNF-α level in either group.
CONCLUSION


It has been observed that even short-term telmisartan treatment had favorable effects on insulin resistance and glucose metabolism compared with lifestyle changes alone. The fundamental effect of telmisartan treatment on insulin resistance renders it a good therapeutic option for hypertensive patients with MetS.",2019,"Serum insulin level and insulin resistance assessed by homeostasis model assessment-insulin resistance were decreased significantly in the telmisartan group (P = 0.040 and P = 0.034, respectively) compared with the controls, while there was no statistically significant change in the lipid profiles of the two groups.","['hypertensive patients with metabolic syndrome (MetS', 'hypertensive patients with MetS', '36 hypertensive patients with MetS', 'Hypertensive Patients with Metabolic Syndrome']","['Telmisartan', 'telmisartan', 'short-term telmisartan']","['Serum Adiponectin and Tumor Necrosis Factor-Alpha Levels', 'insulin resistance, lipid metabolism, and serum adiponectin and tumor necrosis factor-alpha (TNF-α) levels', 'lipid profiles', 'Serum adiponectin level', 'insulin resistance and glucose metabolism', 'anthropometric variables', 'Serum insulin level and insulin resistance assessed by homeostasis model assessment-insulin resistance', 'serum TNF-α level']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",36.0,0.0129323,"Serum insulin level and insulin resistance assessed by homeostasis model assessment-insulin resistance were decreased significantly in the telmisartan group (P = 0.040 and P = 0.034, respectively) compared with the controls, while there was no statistically significant change in the lipid profiles of the two groups.","[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Kiyici', 'Affiliation': '1 Department of Endocrinology and Metabolism, Bursa Yuksek Ihtisas Education and Research Hospital, University of Health Sciences, Bursa, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Guclu', 'Affiliation': '1 Department of Endocrinology and Metabolism, Bursa Yuksek Ihtisas Education and Research Hospital, University of Health Sciences, Bursa, Turkey.'}, {'ForeName': 'Ferah', 'Initials': 'F', 'LastName': 'Budak', 'Affiliation': '2 Department of Immunology, Medical Faculty, Uludag University, Bursa, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Sigirli', 'Affiliation': '3 Department of Bio-Statistics, and Medical Faculty, Uludag University, Bursa, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Tuncel', 'Affiliation': '4 Department of Endocrinology and Metabolism, Medical Faculty, Uludag University, Bursa, Turkey.'}]",Metabolic syndrome and related disorders,['10.1089/met.2018.0129']
1348,30270717,Effects of meal replacement therapy on metabolic outcomes in Thai patients with type 2 diabetes: A randomized controlled trial.,"BACKGROUND


A meal replacement (MR) with a low glycemic index (GI) is possibly beneficial for glycemic control. However, the effects of MR on diabetes mellitus have not been studied among Thai patients with type 2 diabetes (T2DM).
AIM


To compare metabolic outcomes between T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets.
METHODS


A multicenter, open-labeled, randomized controlled trial was conducted. Eligible patients received either ONCE PRO for one meal daily with controlled diets or only controlled diets for 3 months. The differences in metabolic profile between the baseline and end point of each group and between groups were measured.
RESULTS


110 participants were enrolled; the mean difference and standard deviation in hemoglobin A1C (HbA1c) (%) from baseline were -0.21 ± 0.78 ( p  = 0.060) and -0.27 ± 0.60 ( p  = 0.001) in the MR and control groups, respectively; however, there was no significant difference between groups ( p  = 0.637). Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p  = 0.040). Body weight (BW) and body mass index (BMI) were significantly reduced in both groups. There were no significant change in waist circumference, fasting plasma glucose, total cholesterol and triglycerides. Low-density lipoprotein cholesterol (LDL-C) was significantly decreased in the MR group compared with the control group ( p  = 0.049).
CONCLUSIONS


Short-term conventional diet control and the low-GI MR product were associated with a decreased BW and BMI. Changes in the other metabolic outcomes, HbA1c, total cholesterol and triglycerides, were comparable despite ONCE PRO as the MR having a better effect on LDL-C lowering.",2018,Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p = 0.040).,"['110 participants', 'Thai patients with type 2 diabetes (T2DM', 'Thai patients with type 2 diabetes', 'T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets']","['meal replacement (MR) with a low glycemic index (GI', 'ONCE PRO', 'MR', 'meal replacement therapy']","['Body weight (BW) and body mass index (BMI', 'metabolic outcomes', 'waist circumference, fasting plasma glucose, total cholesterol and triglycerides', 'HbA1c', 'metabolic profile', 'metabolic outcomes, HbA1c, total cholesterol and triglycerides', 'Low-density lipoprotein cholesterol (LDL-C', 'standard deviation in hemoglobin A1C (HbA1c']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",110.0,0.0864348,Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p = 0.040).,"[{'ForeName': 'Apussanee', 'Initials': 'A', 'LastName': 'Boonyavarakul', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Phramongkutklao Hospital, Thailand.'}, {'ForeName': 'Rattana', 'Initials': 'R', 'LastName': 'Leelawattana', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Thailand.'}, {'ForeName': 'Chatlert', 'Initials': 'C', 'LastName': 'Pongchaiyakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine, Khonkaen University, Thailand.'}, {'ForeName': 'Supawan', 'Initials': 'S', 'LastName': 'Buranapin', 'Affiliation': 'Division of Endocrinology, Department of Internal medicine, Faculty of Medicine, Chiang Mai University, Thailand.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Phanachet', 'Affiliation': 'Division of Nutrition and Biochemical Medicine, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Pornpoj', 'Initials': 'P', 'LastName': 'Pramyothin', 'Affiliation': 'Division of Nutrition, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Thailand.'}]",Nutrition and health,['10.1177/0260106018800074']
1349,30663606,"Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial.","BACKGROUND


Patients with Parkinson's disease chronically treated with levodopa commonly have delayed or unpredictable onset of its benefits after oral intake. In this study, we assessed the safety and efficacy of CVT-301, a self-administered levodopa oral inhalation powder, for the treatment of patients with Parkinson's disease during off periods.
METHODS


In this randomised, double-blind, placebo-controlled, phase 3 trial, patients were recruited at 65 sites in Canada, Poland, Spain, and the USA. Eligible participants were patients with Parkinson's disease aged 30-85 years, who had daily off periods of 2 h or longer and showed an improvement of 25% or greater in the Unified Parkinson's Disease Rating Scale (UPDRS) motor score from off to on state after use of an oral levodopa plus a dopa-decarboxylase inhibitor combination. Patients were assigned (1:1:1) with a computer-generated randomisation code, in fixed blocks of six, to either CVT-301 60 mg, CVT-301 84 mg, or placebo. Spirometry results and modified Hoehn and Yahr disease stage at screening were used for stratification of treatment groups. Patients, the sponsor, and site personnel were masked to treatment assignment. Each study dose consisted of two capsules administered with an inhaler. Patients were instructed to use the study drug as needed for off periods, and could self-administer up to five doses per day. The primary endpoint was the change in UPDRS motor score from predose to 30 min postdose, assessed at week 12 during an in-clinic off period, in the CVT-301 84 mg group compared with the placebo group. Analysis was by intention to treat. Safety was assessed in all patients who received at least one dose of experimental treatment. This trial is registered with ClinicalTrials.gov, number NCT02240030.
FINDINGS


Between Dec 4, 2014, and Aug 26, 2016, 351 patients were enrolled and randomly assigned to receive CVT-301 60 mg (115 patients), CVT-301 84 mg (120 patients), or placebo (116 patients). Of these, 339 received the assigned study treatment (CVT-301 60 mg, n=113; CVT-301 84 mg, n=114; placebo, n=112) and 290 completed the study (CVT-301 60 mg, n=96; CVT-301 84 mg, n=97; placebo, n=97). The least-squares mean difference in UPDRS motor score change from predose to 30 min postdose was -5·91 (SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83 (1·51; -12·79 to -6·87) for the CVT-301 84 mg group (between-group difference -3·92 [-6·84 to -1·00]; p=0·0088). Treatments were safe and well tolerated. Severe adverse events were reported by 2 (2%) of 112 patients in the placebo group, 7 (6%) of 113 in the CVT-301 60 mg group, and 5 (4%) of 114 in the CVT-301 84 mg group, with no severe adverse event occurring in more than one patient in any treatment group. 11 (3%) of 339 patients had 19 serious adverse events (three [3%] of 112 patients in placebo, six [5%] of 113 in CVT-301 60 mg, and two [2%] of 114 in CVT-301 84 mg). Of these, hypotension and atrial fibrillation were assessed by investigators to be possibly related to the study drug.
INTERPRETATION


CVT-301 can improve UPDRS motor scores of patients with Parkinson's disease during in-clinic off periods, with few severe or serious adverse events. The long-term safety and efficacy of CVT-301 need to be investigated in future studies.
FUNDING


Acorda Therapeutics.",2019,"(SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83","['patients were recruited at 65 sites in Canada, Poland, Spain, and the USA', 'Between Dec 4, 2014, and Aug 26, 2016, 351 patients', ""Patients with Parkinson's disease chronically treated with"", ""patients with Parkinson's disease"", ""Eligible participants were patients with Parkinson's disease aged 30-85 years, who had daily off periods of 2 h or longer and showed an improvement of 25% or greater in the Unified Parkinson's Disease Rating Scale (UPDRS) motor score from off to on state after use of an oral levodopa plus a dopa-decarboxylase inhibitor combination"", ""patients with Parkinson's disease during off periods""]","['placebo', 'CVT-301, a self-administered levodopa oral inhalation powder', 'CVT-301 60 mg, CVT-301 84 mg, or placebo', 'levodopa', 'CVT-301', 'CVT-301 (levodopa inhalation powder']","['safe and well tolerated', 'safety and efficacy', 'Severe adverse events', 'motor function', 'UPDRS motor score change', '19 serious adverse events', 'change in UPDRS motor score', 'hypotension and atrial fibrillation', 'UPDRS motor scores', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0598272', 'cui_str': 'DOPA Decarboxylase Inhibitors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",351.0,0.572548,"(SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Department of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, USA. Electronic address: plewitt1@hfhs.org.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida College of Medicine, Tampa, FL, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Pourcher', 'Affiliation': 'Faculty of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Lopez-Manzanares', 'Affiliation': 'University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Waters', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzínska', 'Affiliation': 'Faculty of Medicine, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedkov', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Batycky', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30405-8']
1350,32408065,Spending the night next to a router - Results from the first human experimental study investigating the impact of Wi-Fi exposure on sleep.,"BACKGROUND


The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure.
OBJECTIVES


The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep.
METHODS


Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility.
RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham.
DISCUSSION


The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure.",2020,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.",['Thirty-four healthy young male subjects (mean\xa0±\xa0SD: 24.1\xa0±\xa02.9 years) spent five nights in the sleep laboratory'],"['GHz Wi-Fi', 'RF-EMF exposure', 'radiofrequency electromagnetic field (RF-EMF']","['subjective sleep parameters', 'global EEG power', 'Sleep']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0556961', 'cui_str': 'GHz'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",34.0,0.0200575,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bueno-Lopez', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hirtl', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}]",International journal of hygiene and environmental health,['10.1016/j.ijheh.2020.113550']
1351,27168434,Patterns of Growth and Decline in Lung Function in Persistent Childhood Asthma.,"BACKGROUND


Tracking longitudinal measurements of growth and decline in lung function in patients with persistent childhood asthma may reveal links between asthma and subsequent chronic airflow obstruction.
METHODS


We classified children with asthma according to four characteristic patterns of lung-function growth and decline on the basis of graphs showing forced expiratory volume in 1 second (FEV1), representing spirometric measurements performed from childhood into adulthood. Risk factors associated with abnormal patterns were also examined. To define normal values, we used FEV1 values from participants in the National Health and Nutrition Examination Survey who did not have asthma.
RESULTS


Of the 684 study participants, 170 (25%) had a normal pattern of lung-function growth without early decline, and 514 (75%) had abnormal patterns: 176 (26%) had reduced growth and an early decline, 160 (23%) had reduced growth only, and 178 (26%) had normal growth and an early decline. Lower baseline values for FEV1, smaller bronchodilator response, airway hyperresponsiveness at baseline, and male sex were associated with reduced growth (P<0.001 for all comparisons). At the last spirometric measurement (mean [±SD] age, 26.0±1.8 years), 73 participants (11%) met Global Initiative for Chronic Obstructive Lung Disease spirometric criteria for lung-function impairment that was consistent with chronic obstructive pulmonary disease (COPD); these participants were more likely to have a reduced pattern of growth than a normal pattern (18% vs. 3%, P<0.001).
CONCLUSIONS


Childhood impairment of lung function and male sex were the most significant predictors of abnormal longitudinal patterns of lung-function growth and decline. Children with persistent asthma and reduced growth of lung function are at increased risk for fixed airflow obstruction and possibly COPD in early adulthood. (Funded by the Parker B. Francis Foundation and others; ClinicalTrials.gov number, NCT00000575.).",2016,"Lower baseline values for FEV1, smaller bronchodilator response, airway hyperresponsiveness at baseline, and male sex were associated with reduced growth (P<0.001 for all comparisons).","['Children with persistent asthma', 'patients with persistent childhood asthma', 'participants in the National Health and Nutrition Examination Survey who did not have asthma']",[],"['FEV1, smaller bronchodilator response, airway hyperresponsiveness', 'Global Initiative for Chronic Obstructive Lung Disease spirometric criteria for lung-function impairment', 'chronic obstructive pulmonary disease (COPD', 'normal pattern of lung-function growth without early decline', 'normal growth', 'growth of lung function', 'abnormal patterns']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma (disorder)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",[],"[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0578019', 'cui_str': 'Normal growth (finding)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}]",684.0,0.0604073,"Lower baseline values for FEV1, smaller bronchodilator response, airway hyperresponsiveness at baseline, and male sex were associated with reduced growth (P<0.001 for all comparisons).","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': ''}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Croteau-Chonka', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Castaldi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': ''}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Lajoie', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stamatoyannopoulos', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Covar', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': ''}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Adkinson', 'Affiliation': ''}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Grasemann', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': ''}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Raby', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Houston', 'Affiliation': ''}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': ''}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': ''}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Silverman', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': ''}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Strunk', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1513737']
1352,30415077,Presence of Small Screens in Bedrooms Is Associated With Shorter Sleep Duration and Later Bedtimes in Children With Obesity.,"BACKGROUND


The presence of small screens in the sleep environment has been associated with shorter sleep duration and later bedtimes in children of normal weight, but the role these devices play in the sleep environment of overweight children is unclear. We sought to examine the association of small screen presence in the sleep environment with sleep behaviors among school-age children with obesity.
METHODS


We surveyed 526 parents of children ages 6 to 12 years old with a body mass index ≥95th percentile who were participating in a randomized trial to treat childhood obesity. Twelve months after enrollment, parents were asked how frequently their child slept with or near a small screen (defined as a cellphone, smartphone, or texting/chat-capable device). We used multivariable linear regression to examine associations of the presence of small screens with sleep duration, waketime, and bedtime.
RESULTS


Compared with children who rarely/never slept with a small screen in their bedroom, children who did so 1 day or more per week had shorter sleep durations and later bedtimes. After we adjusted for television presence in the bedroom, small screen presence was still associated with shorter sleep duration (-9.9 minutes; P = .02) and later weekday (8.8 minutes; P = .03) and weekend (12.0 minutes; P = .03) bedtimes.
CONCLUSIONS


Children with obesity and a small screen present in their sleep environment have shorter sleep durations and later bedtimes than children who rarely/never sleep with a small screen. Pediatricians should consider inquiring about small screens in the bedroom when counseling on healthy sleep and weight management habits.",2019,"BACKGROUND


The presence of small screens in the sleep environment has been associated with shorter sleep duration and later bedtimes in children of normal weight, but the role these devices play in the sleep environment of overweight children is unclear.","['Children With Obesity', 'school-age children with obesity', '526 parents of children ages 6 to 12 years old with a body mass index ≥95th percentile who were participating in a randomized trial to treat childhood obesity']",[],"['shorter sleep durations and later bedtimes', 'shorter sleep duration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]",526.0,0.0414478,"BACKGROUND


The presence of small screens in the sleep environment has been associated with shorter sleep duration and later bedtimes in children of normal weight, but the role these devices play in the sleep environment of overweight children is unclear.","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Duggan', 'Affiliation': 'Division of General Academic Pediatrics (MP Duggan, EM Taveras, MW Gerber, CM Horan, NM Oreskovic), Massachusetts General Hospital for Children.'}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'Division of General Academic Pediatrics (MP Duggan, EM Taveras, MW Gerber, CM Horan, NM Oreskovic), Massachusetts General Hospital for Children; Department of Pediatrics (EM Taveras, NM Oreskovic), Harvard Medical School; Department of Nutrition (EM Taveras), Harvard T. H. Chan School of Public Health (EM Taveras), Boston, Mass.'}, {'ForeName': 'Monica W', 'Initials': 'MW', 'LastName': 'Gerber', 'Affiliation': 'Division of General Academic Pediatrics (MP Duggan, EM Taveras, MW Gerber, CM Horan, NM Oreskovic), Massachusetts General Hospital for Children.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Horan', 'Affiliation': 'Division of General Academic Pediatrics (MP Duggan, EM Taveras, MW Gerber, CM Horan, NM Oreskovic), Massachusetts General Hospital for Children.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Oreskovic', 'Affiliation': 'Division of General Academic Pediatrics (MP Duggan, EM Taveras, MW Gerber, CM Horan, NM Oreskovic), Massachusetts General Hospital for Children; Department of Pediatrics (EM Taveras, NM Oreskovic), Harvard Medical School. Electronic address: noreskovic@partners.org.'}]",Academic pediatrics,['10.1016/j.acap.2018.11.004']
1353,30656454,Effect of structural training on surgical outcomes of residents' first operative laparoscopy: a randomized controlled trial.,"BACKGROUND


Gynecological surgery and resident education have changed during recent decades, thus impacting surgical training. Training on simulators must begin before operating on patients. The objective of this study was to evaluate the effect of a simple curriculum on the surgical outcome of the participants' first operative laparoscopy.
METHODS


This randomized prospective interventional study was carried out in Helsinki University Hospital and Hyvinkää Hospital. We recruited twenty junior residents in Obstetrics and Gynecology, of which half formed a control group and the rest completed the intervention with a theoretical and a practical part. The participants' first laparoscopic salpingectomy was assessed from video recordings by using Objective Structured Assessment of Technical Skills (OSATS) forms and the Numeric Rating Scale (NRS). The surgical outcome and assessed scores were compared between the groups.
RESULTS


We found no differences in operative time, blood loss, or complications, nor in OSATS or NRS scores. In the intervention group, participants with the weakest performances in the simulator, seemed to benefit from the training program more than the participants with the best performances (skill level elevation 29.2-31.6% vs. 21.1-23.3%, respectively). The participants with the best performances in the simulator were scored among the best in the recorded operations as well.
CONCLUSION


In this study, we found no difference in the surgical outcome between the groups. However, the participants with low starting levels in the simulator could elevate their skill levels more, though they did not reach the skill level of those with a high starting level. Consequently, we found elevation in skills levels in the simulator tasks, but not in the surgical outcome. Likely, our simple training program with a fixed number of repetitions was insufficient to reach a plateau in the learning curve, and thus the training program in such a curriculum should be proficiency based.",2019,"We found no differences in operative time, blood loss, or complications, nor in OSATS or NRS scores.","['Helsinki University Hospital and Hyvinkää Hospital', 'twenty junior residents in Obstetrics and Gynecology, of which half formed a control group and the rest completed the intervention with a theoretical and a practical part', ""residents' first operative laparoscopy""]","['structural training', 'simple curriculum']","['Numeric Rating Scale (NRS', 'operative time, blood loss, or complications, nor in OSATS or NRS scores', 'surgical outcomes', 'surgical outcome']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0222045'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",20.0,0.0722335,"We found no differences in operative time, blood loss, or complications, nor in OSATS or NRS scores.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, P.O. Box 100, 00029 HUS, Helsinki, Finland. ewa.jokinen@hus.fi.'}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, P.O. Box 100, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Härkki', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, P.O. Box 100, 00029 HUS, Helsinki, Finland.'}]",Surgical endoscopy,['10.1007/s00464-018-06657-y']
1354,30663462,Performance and perception of haptic feedback in a laparoscopic 3D virtual reality simulator.,"Background:  The benefit of haptic feedback in laparoscopic virtual reality simulators (VRS) is ambiguous. A previous study found 32% faster acquisition of skills with the combination of 3 D and haptic feedback compared to 2 D only. This study aimed to validate perception and effect on performance of haptic feedback by experienced surgeons in the previously tested VRS.  Material and methods:  A randomized single blinded cross-over study with laparoscopists (>100 laparoscopic procedures) was conducted in a VRS with 3 D imaging. One group started with haptic feedback, and the other group without. After performing the suturing task with haptics either enabled or disabled, the groups crossed over to the opposite setting. Face validity was assessed through questionnaires. Metrics were obtained from the VRS.  Results:  The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively. Comparing the metrics for maximum stretch damage between the groups revealed a significantly lower score when a group performed with haptics enabled  p  = .027 (haptic first group) and  p  < .001(haptic last group).  Conclusion:  Haptic feedback in VRS has limited fidelity according to the tested laparoscopic surgeons. In spite of this, significantly less stretch damage was caused with haptics enabled.",2019,"The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively.",['A randomized single blinded cross-over study with laparoscopists (>100 laparoscopic procedures'],"['laparoscopic virtual reality simulators (VRS', 'haptic feedback']","['Performance and perception of haptic feedback', 'Face validity', 'Haptic feedback', 'performance of haptic feedback', 'haptic feedback']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0521291', 'cui_str': 'Laparoscopic-assisted procedure'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042284', 'cui_str': 'Validity of Results'}]",,0.0537111,"The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively.","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Hagelsteen', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bergenfelz', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Anderberg', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2018.1539012']
1355,30638635,"Feasibility, Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer.","BACKGROUND


Increasing evidence suggests that lifestyle factors may decrease the risk of prostate cancer progression. Lifestyle guidelines and tools may support lifestyle modification after diagnosis.
OBJECTIVE


To determine the feasibility and acceptability of a digital lifestyle intervention among men with prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS


A 12-wk pilot randomized controlled trial among 76 men with clinical stage T1-T3a prostate cancer. Eligibility included Internet access, no contraindications to aerobic exercise, and engaging in four or fewer of eight targeted behaviors at baseline.
INTERVENTION


Website, Fitbit One, and text messaging to facilitate adoption of eight behaviors: vigorous activity, smoking cessation, and six diet improvements.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Our primary outcomes were feasibility and acceptability based on recruitment and user data, and surveys, respectively. Secondarily, we evaluated the change in eight lifestyle behaviors, and also objective physical activity. Each factor was assigned one point, for an overall ""P8 score"" (range 0-8). Analysis of covariance (ANCOVA) was conducted. Exploratory outcomes included quality of life, anthropometrics, and circulating biomarkers after 12wk, and behaviors after 1yr.
RESULTS AND LIMITATIONS


At baseline, men in both arms met a median of three targeted behaviors. Sixty-four men (n=32 per arm) completed the study; 88% completed 12-wk assessments (intervention, 94%; control, 82%). Intervention participants wore their Fitbits a median of 82d (interquartile range [IQR]: 72-83), replied to a median of 71% of text messages (IQR: 57-89%), and visited the website a median of 3d (IQR: 2-5) over 12wk. Median (IQR) absolute changes in the P8 score from baseline to 12wk were 2 (1, 3) for the intervention and 0 (-1, 1) for the control arm. The estimated mean score of the intervention arm was 1.5 (95% confidence interval: 0.7, 2.3) higher than that of the control arm at 12wk (ANCOVA p<0.001). Changes were driven by diet rather than exercise. Limitations include self-reported diet and exercise data.
CONCLUSIONS


Overall, in this novel pilot trial, the intervention was feasible and acceptable to men with prostate cancer. Next steps include improving the intervention to better meet individuals' needs and focusing on increasing physical activity in men not meeting nationally recommended physical activity levels.
PATIENT SUMMARY


Tailored print materials combined with technology integration, including the use of a website, text messaging, and physical activity trackers, helped men with prostate cancer adopt healthy lifestyle habits, in particular recommended dietary changes, in the Prostate 8 pilot trial.",2019,The estimated mean score of the intervention arm was 1.5,"['Men with Prostate Cancer', 'Sixty-four men (n=32 per arm) completed the study; 88% completed 12-wk assessments (intervention, 94%; control, 82', '76 men with clinical stage T1-T3a prostate cancer', 'men with prostate cancer']","['Technology-enhanced Behavioral Change Intervention', 'digital lifestyle intervention', 'Website, Fitbit One, and text messaging to facilitate adoption of eight behaviors: vigorous activity, smoking cessation, and six diet improvements']","['feasibility and acceptability', 'feasibility and acceptability based on recruitment and user data, and surveys, respectively', 'quality of life, anthropometrics, and circulating biomarkers after 12wk, and behaviors after 1yr', 'Median (IQR) absolute changes in the P8 score', 'Feasibility, Acceptability, and Behavioral Outcomes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",76.0,0.102029,The estimated mean score of the intervention arm was 1.5,"[{'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Kenfield', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA. Electronic address: stacey.kenfield@ucsf.edu.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Ameli', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Lavaki', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Cedars', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Paciorek', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Monroy', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lucy K', 'Initials': 'LK', 'LastName': 'Tantum', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Signorell', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Carroll', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'June M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}]",European urology,['10.1016/j.eururo.2018.12.040']
1356,31829245,Application of thromboelastography to evaluate the effect of different routes administration of tranexamic acid on coagulation function in total hip arthroplasty.,"BACKGROUND


Tranexamic acid (TXA) is widely used to reduce blood loss and transfusion rates in total hip arthroplasty(THA). Thromboelastography, which can monitor coagulation changes from clotting to fibrinolysis dynamically. In this study, thromboelastography was used to assess the dynamic changes in the coagulation of patients who underwent THA with the administration of TXA.
METHODS


This randomized controlled trial consisted of 207 consecutive patients who underwent primary total hip arthroplasty. Patients were randomized into three groups: topical-TXA group received a topical application of TXA, IV-TXA group received an intravenous injection of TXA, and control group. Thromboelastography was performed 1 day before surgery and first, fourth, seventh days after surgery. The primary outcomes were thromboelastography parameters, the rates of deep vein thrombosis(DVT), and pulmonary embolism(PE). Secondary outcomes included perioperative blood loss, transfusion rates, and other perioperative complications.
RESULTS


The mean calculated total blood loss in the Topical-TXA group were 832.7 ± 279.84 ml and 834.8 ± 322.94 ml in the IV-TXA group, which were significantly reduced (p < 0.05) compared with control groups at 1093.3 ± 379.7 ml. There were no significant differences between topical-TXA and IV-TXA groups in total blood loss or transfusion rates. K and R have reached a nadir from preoperative levels to 4th day postoperatively and then began to increase.α angle and CI peaked from preoperative levels to the fourth day postoperatively and then began to decline.IV-TXA significantly (p < 0.05) promoted coagulation levels compared with topical-TXA and control groups in the early postoperative period. Almost no significant differences were observed between topical-TXA and control groups in thromboelastography parameters.No significant differences were observed in the incidence of thromboembolic complications and other perioperative complications.
CONCLUSIONS


The topical administration of TXA had the same hemostatic effect as intravenous injection tranexamic acid. Coagulation function peaked on 4th day postoperatively and then began to decline. IV-TXA was more enhanced coagulation functions compared with topical-TXA.",2019,There were no significant differences between topical-TXA and IV-TXA groups in total blood loss or transfusion rates.,"['patients who underwent THA with the administration of TXA', 'total hip arthroplasty', 'total hip arthroplasty(THA', '207 consecutive patients who underwent primary total hip arthroplasty']","['thromboelastography', 'topical-TXA and IV-TXA', 'Thromboelastography', 'tranexamic acid', 'topical-TXA', 'IV-TXA', 'topical application of TXA, IV-TXA group received an intravenous injection of TXA, and control group', 'Tranexamic acid (TXA', 'TXA']","['thromboelastography parameters, the rates of deep vein thrombosis(DVT), and pulmonary embolism(PE', 'perioperative blood loss, transfusion rates, and other perioperative complications', 'enhanced coagulation functions', 'incidence of thromboembolic complications and other perioperative complications', 'coagulation function', 'total blood loss or transfusion rates', 'mean calculated total blood loss', 'coagulation levels', 'Coagulation function', 'blood loss and transfusion rates', 'hemostatic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",207.0,0.0455654,There were no significant differences between topical-TXA and IV-TXA groups in total blood loss or transfusion rates.,"[{'ForeName': 'Xingming', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedic, The Fifth Affiliated Hospital Of Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital Of Nanchang University, No. 17, Yongwaizheng Street, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedic, The Fifth Affiliated Hospital Of Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital Of Nanchang University, No. 17, Yongwaizheng Street, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Huading', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedic, The Fifth Affiliated Hospital Of Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China. 491135186@qq.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1497-y']
1357,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE


Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN


A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING


A tertiary health care referral center.
SUBJECTS AND METHODS


The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS


Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION


Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
1358,31558376,"Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial.","BACKGROUND


Strongyloides stercoralis infection is a neglected condition that places people who are immunocompromised at risk of hyperinfection and death. Ivermectin is the drug of choice for the treatment of S stercoralis infection, but there is no definitive evidence on the optimal dose. This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis.
METHODS


Our study was designed as a multicentre, open-label, phase 3, randomised controlled superiority trial. Participants were enrolled in four centres in Italy, three in Spain, and two in the UK, and recruiting sites were predominantly hospitals. Eligible patients were older than 5 years, weighed more than 15 kg, were residents in an area not endemic for S stercoralis, and either were positive for S stercoralis in faecal tests and on serology (any titre) or had a positive serological test with high titres, irrespective of the result of faecal tests. Patients were randomly assigned (1:1) using a computer-generated, blinded allocation sequence (with randomly mixed block sizes of six, eight, and ten participants) to receive either one dose of ivermectin 200 μg/kg or four doses of ivermectin 200 μg/kg (given on days 1, 2, 15, and 16). The primary endpoint was the proportion of participants with clearance of S stercoralis infection at 12 months, which was assessed in all randomly assigned participants who were not lost to follow-up (modified full-analysis set) and in participants in the modified full-analysis set who did not deviate from the assigned treatment regimen (per-protocol set). All participants were included in the safety analysis. The trial was registered with ClinicalTrials.gov, NCT01570504, and is now closed for recruitment.
FINDINGS


Of the 351 patients assessed for eligibility, 309 recruited between March 26, 2013, and May 3, 2017, were randomly assigned to one dose (n=155) or four doses (n=154) of ivermectin. At 12 months in the modified full-analysis set, 86% (95% CI 79 to 91; 102 of 118 participants) had responded to treatment in the single-dose group compared with 85% (77 to 90; 96 of 113 participants) in the four-dose group (risk difference 1·48%, 95% CI -7·55 to 10·52; p=0·75); similar results were observed in the per-protocol set. Adverse events were generally of mild intensity and more frequent in the multiple-dose than in the single-dose group. The trial was terminated early due to futility.
INTERPRETATION


Multiple doses of ivermectin did not show higher efficacy and was tolerated less than a single dose. A single dose should therefore be preferred for the treatment of non-disseminated strongyloidiasis.
FUNDING


There was no funding source for this study.",2019,"This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis.
","['places people who are immunocompromised at risk of hyperinfection and death', '351 patients assessed for eligibility, 309 recruited between March 26, 2013, and May 3, 2017', 'Participants were enrolled in four centres in Italy, three in Spain, and two in the UK, and recruiting sites were predominantly hospitals', 'Eligible patients were older than 5 years, weighed more than 15 kg, were residents in an area not endemic for S stercoralis, and either were positive for S stercoralis in faecal tests and on serology (any titre) or had a positive serological test with high titres, irrespective of the result of faecal tests']","['Ivermectin', 'ivermectin 200 μg/kg or four doses of ivermectin', 'ivermectin']","['proportion of participants with clearance of S stercoralis infection', 'Adverse events']","[{'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036743', 'cui_str': 'Serological Tests'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",309.0,0.334334,"This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis.
","[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Buonfrate', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy. Electronic address: dora.buonfrate@sacrocuore.it.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Salas-Coronas', 'Affiliation': 'Unidad de Medicina Tropical, Hospital de Poniente, El Ejido, Almería, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': 'Barcelona Institute for Global Health, ISGlobal-CRESIB, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Begoña Trevino', 'Initials': 'BT', 'LastName': 'Maruri', 'Affiliation': ""Unitat de Medicina Tropical Vall d'Hebron-Drassanes, Programa de Salut Internacional de l'ICS (PROSICS), Barcelona, Spain.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rodari', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Castelli', 'Affiliation': 'Department of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili General Hospital, Brescia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zammarchi', 'Affiliation': 'Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Florence, Italy; SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': ""Department of Health Sciences, University of Florence, Anna Meyer Children's University Hospital, Florence, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gobbi', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Cabezas-Fernández', 'Affiliation': 'Unidad de Medicina Tropical, Hospital de Poniente, El Ejido, Almería, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Requena-Mendez', 'Affiliation': 'Barcelona Institute for Global Health, ISGlobal-CRESIB, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Godbole', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust London, UK.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Romero', 'Affiliation': 'Department of Medical and Oral Sciences and Biotechnologies, Università degli Studi ""G d\'Annunzio"", Chieti, Italy.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Chiodini', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust London, UK; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Bisoffi', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30289-0']
1359,29504820,Three-step Reduction Therapy of Integrated Chinese and Western Medicine for Thoracolumbar Burst Fracture.,"Objective:  To investigate and compare the efficacy of three-step reduction (TSR) therapy of integrated Chinese and Western Medicine and posterior open (PO) surgery for thoracolumbar burst fracture.  Methods:  We selected 60 patients diagnosed with thoracolumbar burst fracture and received treatment in our hospital from December 2014 to March 2017. According to randomized digital table, they were randomly divided into TSR and PO groups. VAS pain grade, Oswestry disability index, height of centrum front, Cobb's angle of spine, bleeding, and complication of internal fixation of the two groups were compared.  Results:  Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups ( P  < 0.05).  Conclusion:  Through three-step reduction combined pedicle screw fixation surgery, we can achieve satisfied reduction of thoracolumbar burst fracture, rebuild the height of centrum, recover the biomechanics function of spine, and reduce bleeding. Three-step reduction therapy is an effective therapy for thoracolumbar burst fracture.",2019,"RESULTS


Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups (P < 0.05).
",['60 patients diagnosed with thoracolumbar burst fracture and received treatment in our hospital from December 2014 to March 2017'],"['combined pedicle screw fixation surgery', 'three-step reduction (TSR) therapy of integrated Chinese and Western Medicine and posterior open (PO) surgery']","[""VAS pain grade, Oswestry disability index, height of centrum front, Cobb's angle of spine, bleeding, and complication of internal fixation"", 'Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}]",60.0,0.0153025,"RESULTS


Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups (P < 0.05).
","[{'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Decheng', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Hao', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zhongwei', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiaming', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bin', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yong', 'Affiliation': 'Department of Orthopedics, Beijing Chao-Yang hospital of Capital Medical University, Beijing, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2018.1442534']
1360,29394355,Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh.,"Background


Rotavirus (RV)-specific immunoglobulin A (IgA) responses following oral RV vaccination are impaired in low-income countries, where the utility of RV-IgA as a correlate of protection (CoP) remains unclear. In a monovalent oral RV vaccine (Rotarix) efficacy trial among infants in Dhaka, Bangladesh, we identified factors associated with poor RV-IgA responses and explored the utility of RV-IgA as a CoP.
Methods


Infants were randomized to receive Rotarix or no Rotarix at 10 and 17 weeks of life and followed with active diarrheal surveillance. RV-IgA concentration, seroconversion, and seropositivity were determined at 18 weeks of life and analyzed for correlation(s) with rotavirus diarrhea (RVD) and for contribution to Rotarix vaccine effect.
Results


Among vaccinated infants, overall RV-IgA geometric mean concentration was 21 U/mL; only 27% seroconverted and 32% were seropositive after vaccination. Increased RV-specific maternal antibodies significantly impaired immunogenicity. Seroconversion was associated with reduced risk of RVD through 1 year of life, but RV-IgA seropositivity only explained 7.8% of the vaccine effect demonstrated by the clinical endpoint (RVD).
Conclusions


RV-IgA responses were low among infants in Bangladesh and were significantly impaired by maternal antibodies. RV-IgA is a suboptimal CoP in this setting; an improved CoP for RV in low-income countries is needed.
Clinical Trials Registration


NCT01375647.",2018,"Results


Among vaccinated infants","['Infants in Bangladesh', 'infants in Dhaka, Bangladesh', 'vaccinated infants']","['monovalent oral RV vaccine (Rotarix', 'Rotarix or no Rotarix']","['clinical endpoint (RVD', 'Conclusions\n\n\nRV-IgA responses', 'overall RV-IgA geometric mean concentration', 'RV-IgA concentration, seroconversion, and seropositivity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.03168,"Results


Among vaccinated infants","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Marya', 'Initials': 'M', 'LastName': 'Carmolli', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Dickson', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'E Ross', 'Initials': 'ER', 'LastName': 'Colgate', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Diehl', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Muhammad Ikhtear', 'Initials': 'MI', 'LastName': 'Uddin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shahidul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Motaher', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Tanzeem Ahmed', 'Initials': 'TA', 'LastName': 'Rafique', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur Rahman', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nayak', 'Affiliation': 'Center for Public Health Genomics and Department of Public Health Sciences, University of Virginia, Charlottesville.'}, {'ForeName': 'Josyf C', 'Initials': 'JC', 'LastName': 'Mychaleckyj', 'Affiliation': 'Center for Public Health Genomics and Department of Public Health Sciences, University of Virginia, Charlottesville.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Laboratory of Specialized Clinical Studies, Cincinnati Children's Hospital Medical Center, Ohio.""}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Petri', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont Larner College of Medicine, Burlington.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy076']
1361,30665815,Development and Prospective Randomized Evaluation of a Decision Aid for Prostate-specific Antigen-based Early Detection of Prostate Cancer in Men Aged Between 55 and 69Yr: The PSAInForm Trial.,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.",2019,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.",['Men Aged Between 55 and 69Yr'],['Decision Aid for Prostate-specific Antigen-based Early Detection of Prostate Cancer'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],,0.0471366,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Semjonow', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany. Electronic address: semjono@uni-muenster.de.'}, {'ForeName': 'Hans-Werner', 'Initials': 'HW', 'LastName': 'Hense', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schlößler', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Simbrich', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Borowski', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bothe', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kruse', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Tiedje', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuss', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Charles Christian', 'Initials': 'CC', 'LastName': 'Adarkwah', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany; Department of Health Services Research and General Practice, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Maisel', 'Affiliation': 'Department of General Medicine, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Jendyk', 'Affiliation': 'Department of General Medicine, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Kurosinski', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerß', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Heidinger', 'Affiliation': 'Cancer Registry of North Rhine-Westphalia, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tschuschke', 'Affiliation': 'Berufsverband der Deutschen Urologen, Landesverband Westfalen-Lippe, Muenster, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Becker', 'Affiliation': 'Hausaerzteverbund Muenster, Muenster, Germany.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus University Medical Center, Erasmus University Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus University Medical Center, Erasmus University Rotterdam, The Netherlands.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhoff', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}]",European urology,['10.1016/j.eururo.2019.01.008']
1362,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND


New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM).
METHODS


In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level.
RESULTS


Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
CONCLUSION


In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031']
1363,30463434,Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media.,"Acute otitis media (AOM) is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. We assessed (1) the rates of antimicrobial prescribing by pediatric emergency department clinicians using a smartphone otoscope device as compared with a conventional otoscope and (2) clinician acceptability of the smartphone device. We conducted a randomized control study in children's hospital emergency departments over 6 months. More than 1500 encounters were analyzed. The odds of prescribing antibiotics after being given a diagnosis of AOM by clinicians assigned to the smartphone group was 11% higher than the conventional group (18.8% vs 18.0%, odds ratio = 1.106,  P  = .600). Eight (73%) of the 11 physicians in the smartphone group preferred the smartphone device over the conventional otoscope. Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.",2019,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"['Acute otitis media (AOM', ""children's hospital emergency departments over 6 months"", 'Acute Otitis Media']","['smartphone otoscope', 'Smartphone Otoscope and Conventional Otoscope', 'smartphone otoscope device']","['odds of prescribing antibiotics', 'smartphone device']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0182098', 'cui_str': 'Otoscopes'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",,0.0406635,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"[{'ForeName': 'K Ning', 'Initials': 'KN', 'LastName': 'Chan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silverstein', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Bryan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McCracken', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Wendalyn K', 'Initials': 'WK', 'LastName': 'Little', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andi L', 'Initials': 'AL', 'LastName': 'Shane', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Clinical pediatrics,['10.1177/0009922818812480']
1364,30499837,"Analgesic Potentials of Preoperative Oral Pregabalin, Intravenous Magnesium Sulphate and their Combination in Acute Post-thoracotomy Pain.","OBJECTIVES


To investigate the effects of the preoperative combination of oral pregabalin and intravenous magnesium sulphate as analgesic adjuvants in post thoracotomy pain.
METHODS


One hundred and twenty patients with ASA physical status II were allocated randomly into one of four groups. Group MP received 300▒mg pregabalin orally and an intravenous (IV) infusion of magnesium sulphate 50▒mg/kg mixed with 200▒mL normal saline (NS); Group P received 300▒mg pregabalin orally and 200▒mL NS infusion; Group M received an IV infusion of magnesium sulphate 50▒mg/kg mixed with 200▒mL NS and a placebo capsule; and Group C received placebo capsule and an IV infusion of 200▒mL NS. All medications were given 1 hour before surgery in all groups. In the first 24 hours postoperatively, total morphine consumption, the visual analogue scale (0-10 VAS) - used as a pain measurement tool - and postoperative nausea and vomiting (PONV) were assessed .
RESULTS


The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively. VAS scores were in the accepted range (≤4) in the four groups throughout the first 24 hours, as all patients were on patient controlled analgesia (PCA). However, there was a statistically significant difference at 0 and 4 hours postoperatively in favor of groups MP and P. PONV decreased significantly in groups MP, P and M in comparison to group C (P <0.001).
CONCLUSION


The combined preoperative single dose of Pregabalin and magnesium sulphate is an effective method for attenuating postoperative pain and total morphine consumption in patients undergoing thoracotomy.",2018,"The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively.","['patients undergoing thoracotomy', 'One hundred and twenty patients with ASA physical status II', 'Acute Post-thoracotomy Pain']","['Pregabalin, Intravenous Magnesium Sulphate', 'mL normal saline (NS); Group P received 300▒mg pregabalin', 'oral pregabalin and intravenous magnesium sulphate', 'magnesium sulphate 50▒mg/kg mixed with 200▒mL NS and a placebo capsule', 'pregabalin', 'magnesium sulphate 50▒mg/kg mixed with 200▒', 'Pregabalin and magnesium sulphate', 'placebo capsule and an IV infusion of 200▒mL NS']","['total morphine consumption, the visual analogue scale (0-10 VAS) - used as a pain measurement tool - and postoperative nausea and vomiting (PONV', 'VAS scores', 'postoperative pain and total morphine consumption', 'total morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",120.0,0.18884,"The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively.","[{'ForeName': 'Ahmed Salah', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Aktham Adel', 'Initials': 'AA', 'LastName': 'Shoukry', 'Affiliation': 'Anesthesia, ICU& Pain management, Faculty of Medicine, Ain Shams University,Egypt.'}, {'ForeName': 'Mahmoud Ahmed Mohammed', 'Initials': 'MAM', 'LastName': 'Kamel', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Ashraf Mohammed Yehia', 'Initials': 'AMY', 'LastName': 'Heikal', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Naglaa Abdulla', 'Initials': 'NA', 'LastName': 'Ahmed', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000673']
1365,30660594,Financial incentives for achieving and maintaining viral suppression among HIV-positive adults in Uganda: a randomised controlled trial.,"BACKGROUND


Viral suppression among HIV-positive individuals is essential for protecting health and preventing HIV transmission. Financial incentives have shown promise in modifying various health behaviours in low-income countries but few studies have assessed whether they can improve HIV treatment outcomes. We aimed to determine the impact of time-limited financial incentives on viral suppression among HIV-positive adults in rural Uganda.
METHODS


We did a randomised controlled trial in four rural Ugandan parishes. We recruited HIV-positive individuals (aged ≥18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered. Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART. Eligibility to participate in the study did not depend on current ART or viral suppression status. Participants were randomly allocated (1:1) to the financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards were used to reveal study group assignment. We measured participants' viral load at baseline and at weeks 6, 12, 24, and 48. At each timepoint, we provided results and viral load counselling. Participants in the intervention group received financial incentives for viral suppression at weeks 6, 12, and 24, with incentive amounts increasing from US$4 to $12·5. The primary outcome was viral suppression (viral load <400 copies per mL) at 24 weeks in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02890459.
FINDINGS


Between June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group. Of these, 324 were enrolled from community health campaigns and 76 from the government clinic. Eight (2%) withdrew from the study and were not included in analyses. Over the 48-week follow-up period, 35 (9%) died or were lost-to-follow-up. Participants' median daily income was $0·79. At baseline, 300 participants (77%) were virally suppressed. In intention-to-treat analyses, 168 participants (84%) in the intervention group and 156 (82%) in the control group were virally suppressed at 24 weeks (odds ratio 1·14, 95% CI 0·68-1·93, p=0·62). Six participants (3%) in the control group and four (2%) in the intervention group had adverse events. Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident. No adverse events or deaths were related to study participation.
INTERPRETATION


Financial incentives had no effect on viral suppression among HIV-positive adults. High baseline viral suppression and provision of viral load results might have contributed to high viral suppression among participants. These findings highlight the need for interventions that promote achievement of viral suppression among unsuppressed individuals.
FUNDING


National Institute of Mental Health at the US National Institutes of Health.",2019,"Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident.","['HIV-positive adults in Uganda', 'HIV-positive individuals', 'HIV-positive adults in rural Uganda', '324 were enrolled from community health campaigns and 76 from the government clinic', 'four rural Ugandan parishes', 'HIV-positive individuals (aged ≥18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered', 'Between June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group', 'Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART']","['financial incentives for viral suppression', 'financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards']","['viral suppression', 'viral suppression (viral load', 'adverse events or deaths', 'adverse events', 'median daily income']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4704708', 'cui_str': 'Pre-Print'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks (finding)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",400.0,0.343513,"Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident.","[{'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine and Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: hthirumu@upenn.edu.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Marson', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Devy', 'Initials': 'D', 'LastName': 'Emperador', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(18)30330-8']
1366,31618704,"Cetuximab, fluorouracil and cisplatin with or without docetaxel for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CeFCiD): an open-label phase II randomised trial (AIO/IAG-KHT trial 1108).","BACKGROUND


The combination of cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC) is the reference first-line treatment for recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). We analysed whether treatment intensification by the addition of docetaxel to PFC improved efficacy in R/M SCCHN.
METHODS


A total of 180 patients with R/M SCCHN (1:1) were assigned to receive either cisplatin (40 mg/m 2 ), docetaxel (40 mg/m 2 ) and 5-FU (2000 mg/m 2 ) at days 1 and 8 and cetuximab (400/250 mg/m 2 ) at days 1, 8 and 15 (DPFC) or standard cisplatin (100 mg/m 2 ) at day 1, 5-FU (1000 mg/m 2 ) at days 1-4 and cetuximab (400/250 mg/m 2 ) at days 1, 8 and 15 (PFC). Chemotherapy was repeated every 21 days and continued for a maximum of 6 cycles in absence of disease progression or limiting toxicity, followed by cetuximab maintenance (500 mg/m 2  every 2 weeks). The primary end-point was progression-free survival (PFS).
RESULTS


A preplanned interim analysis for toxicity after 20 patients/arm revealed excessive grade 3 and 4 gastrointestinal (65%) and infectious toxicities (35%) in arm A, which led to dose reduction of cisplatin to 30 mg/m 2  and 5-FU to 1000 mg/m 2  for subsequent patients. With a median follow-up of 2 years, grade 4 toxicities were 21.3% vs. 30.8% for DPFC and PFC, respectively. More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively. For DPFC and PFC, the median PFS was 6.3 vs. 6.4 months (hazard ratio [HR] = 0.97, p = 0.87), the median overall survival was 8.9 vs. 10.6 months (HR = 1.29 p = 0.1) and response rates were 38.2% vs. 31.9% (p = 0.9), respectively.
CONCLUSIONS


DPFC failed to improve efficacy in R/M SCCHN. On the contrary, a high toxicity and mortality rate was detected in both arms, which underscores the vulnerability of patients with R/M SCCHN, and research on the need for further optimisation of the front-line chemotherapy backbone is ongoing.",2019,"More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively.","['180 patients with R/M SCCHN (1:1', 'recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', 'patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CeFCiD']","['docetaxel', '5-FU', 'cetuximab', 'Cetuximab, fluorouracil and cisplatin with or without docetaxel', 'cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC', 'standard cisplatin', 'cisplatin', 'Chemotherapy']","['median PFS', 'grade 4 toxicities', 'progression-free survival (PFS', 'median overall survival', 'infectious toxicities', 'toxicity and mortality rate', 'response rates', 'deaths', 'toxicity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",180.0,0.0574359,"More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Klinghammer', 'Affiliation': 'Department of Hematology & Oncology, Charité University, Berlin, Germany. Electronic address: konrad.klinghammer@charite.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dietz', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Urooncology, West German Cancer Center, Clinic for Internal Medicine (tumor research) and Clinic for Urology, University of Duisburg-Essen Medical School, Essen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stöhlmacher', 'Affiliation': 'Department of Tumorgenetics Bonn, Bonn, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Knipping', 'Affiliation': 'Department of Head and Neck Surgery, Klinikum Dessau, Dessau-Roßlau, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Department of Hematology and Oncology, Helios Duisburg, Duisburg, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Guntinas-Lichius', 'Affiliation': 'Department of Otorhinolaryngology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Frickhofen', 'Affiliation': 'Department of Hematology & Oncology and Palliative Care, HELIOS Dr Horst Schmidt Kliniken, Wiesbaden, Germany.'}, {'ForeName': 'H-W', 'Initials': 'HW', 'LastName': 'Lindeman', 'Affiliation': 'Department of Hematology & Oncology, KKH Hagen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haxel', 'Affiliation': 'Department of Otolaryngology, AMEOS Klinikum Haldensleben, Haldensleben, Germany; Department of Otolaryngology, Head and Neck Surgery, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Große-Thie', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology, Palliative Medicine, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zipfel', 'Affiliation': 'Department of Internal Medicine III, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Knoedler', 'Affiliation': 'University Cancer Center Leipzig, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Berlin, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.018']
1367,30578396,A musical intervention for respiratory comfort during noninvasive ventilation in the ICU.,"Discomfort associated with noninvasive ventilation (NIV) may participate in its failure. We aimed to determine the effect of a musical intervention on respiratory discomfort during NIV in patients with acute respiratory failure (ARF).An open-label, controlled trial was performed over three centres. Patients requiring NIV for ARF were randomised to either a musical intervention group (where they received a musical intervention and were subjected to visual deprivation during the first 30 min of each NIV session), a sensory deprivation group (where they wore insulating headphones and were subjected to visual deprivation during the first 30 min of each NIV session), or a control group (where they received NIV as routinely performed). The primary outcome was the change in respiratory discomfort before and after 30 min of the first NIV session.A total of 113 patients were randomised (36 in the musical intervention group, 38 in the sensory deprivation group and 39 in the control group). Median (interquartile range (IQR)) change in respiratory discomfort was 0 (-1; 1) between the musical intervention and control groups (p=0.7). Between groups comparison did not evidence any significant variation of respiratory parameters across time or health-related quality of life (HRQoL) at day-90. The Peri-traumatic Distress Inventory (PDI) at intensive care unit (ICU) discharge was reduced in musical intervention group patients. However, a 30 min musical intervention did not reduce respiratory discomfort during NIV for ARF in comparison to conventional care or sensory deprivation.",2019,Between groups comparison did not evidence any significant variation of respiratory parameters across time or health-related quality of life (HRQoL) at day-90.,"['patients with acute respiratory failure (ARF).An open-label', 'A total of 113 patients were randomised (36 in the musical intervention group, 38 in the sensory deprivation group and 39 in the control group', 'Patients requiring NIV for ARF']","['noninvasive ventilation (NIV', 'sensory deprivation group (where they wore insulating headphones', 'musical intervention group (where they received a musical intervention', 'musical intervention']","['change in respiratory discomfort', 'Peri-traumatic Distress Inventory (PDI) at intensive care unit (ICU) discharge', 'Median (interquartile range (IQR)) change in respiratory discomfort', 'respiratory parameters across time or health-related quality of life (HRQoL', 'respiratory discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036674', 'cui_str': 'Sensory Deprivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0036674', 'cui_str': 'Sensory Deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",113.0,0.111405,Between groups comparison did not evidence any significant variation of respiratory parameters across time or health-related quality of life (HRQoL) at day-90.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Messika', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': 'Yolaine', 'Initials': 'Y', 'LastName': 'Martin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Maquigneau', 'Affiliation': 'Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Puechberty', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Henry-Lagarrigue', 'Affiliation': 'Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Stoclin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Panneckouke', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Villard', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Dechanet', 'Affiliation': 'Unité de Recherche Clinique Paris-Nord, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lafourcade', 'Affiliation': 'Dépt de Biostatistiques, Santé Publique et Information Médicale, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': ""Dépt de Biostatistique, Santé Publique et Information Médicale, Centre de Pharmaco-Epidémiologie de l'AP-HP, Sorbonne Université, CIC 1421, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France.""}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, AP-HP, Colombes, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01873-2018']
1368,30361250,"Sertraline in symptomatic chronic breathlessness: a double blind, randomised trial.","Does sertraline provide symptomatic relief for chronic breathlessness in people with advanced disease whose underlying cause(s) are optimally treated?223 participants with chronic breathlessness (modified Medical Research Council breathlessness scale ≥2) who had optimal treatment of underlying cause(s) were randomised 1:1 to sertraline 25-100 mg (titrated upwards over 9 days) or placebo for 4 weeks. The primary outcome was the proportion who had an improvement in intensity of current breathlessness >15% from baseline on a 100-mm visual analogue scale.The proportion of people responding to sertraline was similar to placebo for current breathlessness on days 26-28 (OR 1.00, 95% CI 0.71-1.40) and for other measures of breathlessness. Quality of life in the sertraline arm had a higher likelihood of improving than in the placebo arm over the 4 weeks (OR 0.21, 95% CI 0.01-0.41; p=0.044). No differences in performance status, anxiety and depression, or survival were observed. Adverse event rates were similar between arms.Sertraline does not appear to provide any benefit over placebo in the symptomatic relief of chronic breathlessness in this patient population.",2019,Sertraline does not appear to provide any benefit over placebo in the symptomatic relief of chronic breathlessness in this patient population.,"['symptomatic chronic breathlessness', 'people with advanced disease whose underlying cause(s) are optimally treated?223 participants with chronic breathlessness (modified Medical Research Council breathlessness scale ≥2) who had optimal treatment of underlying cause(s']","['sertraline', 'sertraline 25-100\u2005mg (titrated upwards over 9\u2005days) or placebo', 'placebo', 'Sertraline']","['Quality of life', 'performance status, anxiety and depression, or survival', '100-mm visual analogue scale', 'Adverse event rates', 'proportion who had\xa0an improvement in intensity of current breathlessness']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",,0.73576,Sertraline does not appear to provide any benefit over placebo in the symptomatic relief of chronic breathlessness in this patient population.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Louw', 'Affiliation': 'McCloud Consulting Group, Narabang Way, Belrose, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'McCloud Consulting Group, Narabang Way, Belrose, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Davidson', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Respiratory and Sleep Medicine, Austin Health, Heidelberg, Australia.'}, {'ForeName': 'Dimitar', 'Initials': 'D', 'LastName': 'Sajkov', 'Affiliation': 'Flinders Medical Centre, Dept of Respiratory and Sleep Medicine, Medical Centre Drive, Bedford Park, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'Deakin Health Economics, School of Health and Social Development, Deakin University, Burwood, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Doogue', 'Affiliation': 'University of Otago, Christchurch and Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Abernethy', 'Affiliation': 'Discipline of Palliative and Supportive Services, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}]",The European respiratory journal,['10.1183/13993003.01270-2018']
1369,30569067,"Native Whey Induces Similar Post Exercise Muscle Anabolic Responses as Regular Whey, Despite Greater Leucinemia, in Elderly Individuals.","OBJECTIVE


Elderly muscle seems less sensitive to the anabolic stimulus of a meal. Changes in blood concentrations of leucine are suggested as one important trigger of the anabolic response in muscle. The aim of this study was to investigate whether native whey protein, containing high amounts of leucine, may be a more potent stimulator of muscle protein synthesis (MPS) in elderly than regular whey protein (WPC-80) or milk.
DESIGN


Randomized controlled partial crossover.
SETTING


Norwegian School of Sport Sciences.
PARTICIPANTS


21 healthy elderly men and women (≥70 years).
INTERVENTION


Participants received either 20 g of WPC-80 and native whey (n = 11) on separate days in a crossover design, or milk (n = 10). Supplements were ingested immediately and two hours after a bout of lower body heavy-load resistance exercise.
MEASUREMENTS


Blood samples and muscle biopsies were collected to measure blood concentrations of amino acids by gas-chromatography mass spectrometry (GCMS), phosphorylation of p70S6K, 4E-BP1 and eEF-2 by immunoblotting and mixed muscle fractional synthetic rate (FSR) by use of [2H5]phenylalanine-infusion, GCMS and isotope-ratio mass spectrometry.
RESULTS


Native whey increased blood leucine concentrations more than WPC-80 (P < 0.05), but not p70S6K phosphorylation or mixed muscle FSR. Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014). Native whey reached higher mixed muscle FSR values than milk (P = 0.026) 1-3h after exercise.
CONCLUSIONS


Despite greater increases in blood leucine concentrations than WPC-80 and milk, native whey was only superior to milk concerning increases in MPS and phosphorylation of P70S6K during a 5-hour post-exercise period in elderly individuals.",2019,Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014).,"['Elderly Individuals', '21 healthy elderly men and women (≥70 years', 'Norwegian School of Sport Sciences', 'elderly than regular whey protein (WPC-80) or milk', 'elderly individuals']","['20 g of WPC-80 and native whey', 'WPC-80']","['blood concentrations of amino acids by gas-chromatography mass spectrometry (GCMS), phosphorylation of p70S6K, 4E-BP1 and eEF-2 by immunoblotting and mixed muscle fractional synthetic rate (FSR) by use of [2H5]phenylalanine-infusion, GCMS and isotope-ratio mass spectrometry', 'blood leucine concentrations', 'MPS and phosphorylation of P70S6K', 'mixed muscle FSR values', 'p70S6K phosphorylation or mixed muscle FSR', 'P70S6K phosphorylation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0452720', 'cui_str': 'Whey'}]","[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0024868', 'cui_str': 'Spectrum Analysis, Mass-Gas Chromatography'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1136240', 'cui_str': 'Ribosomal Protein S6 Kinases, 70-kDa'}, {'cui': 'C0020985', 'cui_str': 'Immunoblotting'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0037813', 'cui_str': 'Spectrum Analysis, Mass'}, {'cui': 'C0005768'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.0224732,Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hamarsland', 'Affiliation': 'Håvard Hamarsland, Department of Physical Performance, Norwegian School of Sport Sciences, P.O. Box 4014 Ullevål Stadion, 0806 Oslo, Norway, Tel: +47 93445916. Havard.hamarsland@gmail.com.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Aas', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Nordengen', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holte', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garthe', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cotter', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ''}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Benestad', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1105-6']
1370,30635252,"Comparison of two schedules of two-dose priming with the ten-valent pneumococcal conjugate vaccine in Nepalese children: an open-label, randomised non-inferiority controlled trial.","BACKGROUND


Nepalese infants receive ten-valent pneumococcal conjugate vaccine (PCV10) with a 1 month interval between priming doses for programmatic reasons. We aimed to investigate whether immune responses to PCV10 serotypes were non-inferior if the second priming dose of PCV10 was delivered at a 1 month interval as opposed to a 2 month interval.
METHODS


We did an open-label, randomised, parallel group trial in healthy Nepalese infants aged 40-60 days at Patan Hospital, Kathmandu, Nepal. Children were eligible for inclusion if they were healthy, were born at more than or equal to 37 weeks' gestation, were residing in Kathmandu, and had not had any previous vaccinations other than BCG, and oral polio vaccine. Participants were randomly assigned (1:1) by means of a computer-generated list with randomly varying permuted block sizes accessed through a validated web-based interface, to receive PCV10 either at 6 weeks and 10 weeks of age (6 + 10 group) or at 6 weeks and 14 weeks of age (6 + 14 group), with both groups receiving a booster at 9 months of age. Laboratory staff, masked to study intervention, analysed serum samples for antibodies against PCV10 serotypes by ELISA. The primary outcome was to determine whether the 6 + 10 schedule was non-inferior to the 6 + 14 schedule at 9 months of age, on the basis of the proportion of infants with serotype-specific IgG greater than or equal to 0·35 μg/mL. Non-inferiority was established with a 10% margin, and the primary endpoint was measured in a modified intention-to-treat population, which included only participants who successfully had a blood sample collected. This trial is registered at ClinicalTrials.gov, number NCT02385513.
FINDINGS


Between Aug 21, 2015, and April 4, 2016, 304 Nepalese children were randomly assigned to either the 6 + 10 group (n=152) or the 6 + 14 group (n=152). At 9 months of age, the 6 + 10 schedule was non-inferior for serotype 5 (79 [55·2%] of 143 vs 78 [53·4%] of 146, difference 1·82% [95% CI -9·6 to 13·25], p=0·021), serotype 9V (66 [46·1%] of 143 vs 55 [37·6%] of 146, difference 8·48% [-2·84 to 19·8], p=0·001), serotype 14 (110 [77·4%] of 142 vs 110 [74·8%] of 147, difference 2·63% [-7·27 to 12·54], p=0·006), and serotype 19F (135 [95%] of 142 vs 146 [100%] of 146, difference -4·92% [-9·86 to 0], p=0·022). At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062). After the booster dose, at 10 months of age, there were no significant differences in immunogenicity (proportion of children with antibody greater than or equal to 0.35 μg/mL) for any of the ten serotypes, when comparing the two schedules. Serious adverse events occurred in 32 participants, 11 (7%) of 152 in the 6 + 10 group and 21 (14%) of 152 in the 6  +  14 group.
INTERPRETATION


The 6 week, 14 week, and 9 month schedule should be implemented where possible. However, post-booster responses, which are thought to drive herd immunity, were similar in the two schedules. Therefore, the 6 week, 10 week, and 9 month schedule is an alternative that can be used when logistically necessary, and is expected to provide herd protection.
FUNDING


Gavi, the Vaccine Alliance.",2019,"At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062).","['304 Nepalese children', 'Nepalese children', 'Nepalese infants receive ten', ""Children were eligible for inclusion if they were healthy, were born at more than or equal to 37 weeks' gestation, were residing in Kathmandu, and had not had any previous vaccinations other than BCG, and oral polio vaccine"", 'healthy Nepalese infants aged 40-60 days at Patan Hospital, Kathmandu, Nepal', 'Between Aug 21, 2015, and April 4, 2016']","['valent pneumococcal conjugate vaccine (PCV10', 'valent pneumococcal conjugate vaccine', 'PCV10', 'computer-generated list with randomly varying permuted block sizes accessed through a validated web-based interface, to receive PCV10']","['immunogenicity', 'Serious adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",304.0,0.327707,"At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062).","[{'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Kandasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: rama.kandasamy@paediatrics.ox.ac.ukw.'}, {'ForeName': 'Meeru', 'Initials': 'M', 'LastName': 'Gurung', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Thorson', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wahl', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Berbers', 'Affiliation': 'National Institute for Public Health and the Environment, Bilthoven, Utrecht, Netherlands.'}, {'ForeName': 'Kier', 'Initials': 'K', 'LastName': 'Finnegan', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ansari', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Paudel', 'Affiliation': 'Child Health Division, Ministry of Health, Kathmandu, Nepal.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Murdoch', 'Affiliation': 'Department of Pathology, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Brien"", 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dominic F', 'Initials': 'DF', 'LastName': 'Kelly', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30568-1']
1371,30616685,Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.,"BACKGROUND


Robot-assisted gait training (RAGT) was developed to restore gait function by promoting neuroplasticity through repetitive locomotor training and has been utilized in gait training. However, contradictory outcomes of RAGT have been reported for patients with Parkinson's disease (PD). In addition, the mechanism of the RAGT treatment effect is still unknown. This study aims to investigate the effects of RAGT on gait velocity in patients with PD and to unveil the mechanisms of these effects.
METHODS


This is a prospective, single-blind, single-center, randomized controlled trial. Eligible participants will be randomly allocated to: 1) a Walkbot-S™ RAGT group or 2) a treadmill training group. The participants will receive three 45-min sessions of each intervention per week for 4 weeks. Gait speed during RAGT will be targeted to the maximal speed depending on the participant's height; the same principle will be applied to the treadmill training group to match the training intensity. The primary outcome measure is gait speed measured by the 10-Meter Walk Test at a comfortable pace under single-task conditions. Secondary outcomes include dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging. Baseline assessments (T0) will be conducted to acquire clinical characteristics and outcome measure values before the intervention. Postintervention assessments (T1) will compare immediate efficacies within 3 days after the intervention. Follow-up assessments (T2) will be conducted 1 month after the intervention. Considering an alpha of 0.05 and a power of 80%, the total number of participants to be recruited is 44.
DISCUSSION


This study will reveal the effect of RAGT using an exoskeletal robot, not only on gait speed, but also on gait automaticity, balance function, fall risk, quality of life, and disease severity. In addition, the study will shed new light on the mechanism of the RAGT effect by evaluating changes in gait automaticity and brain functional networks.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03490578 . Registered on 21 March 2018.",2019,"Secondary outcomes include dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging.","[""patients with Parkinson's disease"", ""patients with Parkinson's disease (PD"", 'Eligible participants', 'patients with PD']","['Robot-assisted gait training (RAGT', 'Walkbot-S™ RAGT group or 2) a treadmill training group', 'robot-assisted gait training', 'RAGT']","['gait velocity', 'gait speed measured by the 10-Meter Walk Test at a comfortable pace under single-task conditions', ""dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging"", 'Gait speed', 'gait automaticity, balance function, fall risk, quality of life, and disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0222045'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0800802,"Secondary outcomes include dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging.","[{'ForeName': 'Min-Gu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Seo Jung', 'Initials': 'SJ', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Iee', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Haeng', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea. hgseo80@gmail.com.'}]",Trials,['10.1186/s13063-018-3123-4']
1372,30614328,Fetal growth trajectories and their association with maternal and child characteristics.,"Background:  The growth of the fetus is a complex process, influenced by genetic and environmental factors. Longitudinal patterns of fetal growth are required to fully understand this process, however to date, a paucity of data exists in this area.Objective: To identify fetal growth trajectories in-utero and to assess their association with maternal and child characteristics up to 5 years postnatal. Methods:  Data from 781 mother-child pairs from the ROLO longitudinal birth cohort study were analyzed. The ROLO study was a randomized control trial of a low glycemic index diet in pregnancy to prevent recurrence of macrosomia. Fetal ultrasound measurements were recorded at 20 and 34 weeks gestation, and birth weight was recorded. Abdominal circumference (AC), weight (fetal weight, or birth weight), a standardized proxy for length (femur length or birth length, individually standardized), and AC:length ratio were examined for trajectory classes using latent class trajectory mixture models. Two-, three-, four-, and five-class models were evaluated for fit, using a linear (first order) trajectory over three time-points. ANOVA and chi-square tests were applied to test associations between trajectory membership and maternal and child characteristics up to age 5. Results:  For AC, two fetal growth trajectories were identified, with 29% of participants on a ""slow"" trajectory and 71% on a ""fast"" trajectory. Those on a fast trajectory had higher rates of maternal impaired glucose tolerance (28.7 versus 16.5%, p<.001) and higher rates of mean child 5-year body mass index (BMI) centiles (64th versus 58th centile, p<.05) compared to those on the slow trajectory. For estimated fetal weight, four trajectories were identified, with 4% on a ""very-slow"" trajectory, 63% in a ""moderate-slow"" trajectory, 30% in a ""moderate-fast"" trajectory and 3% on a ""very-fast"" trajectory. Mothers with a fetus on the fastest trajectory had higher antenatal serum glucose levels (p<.05), and were more likely to deliver by cesarean section (59.1 versus 20%, p<.001). At 5 years of age, children on the fastest growth trajectory had the highest mean BMI centile (86th versus 60th centile, p<.05). Conclusions:  This study shows that specific fetal growth trajectories may be associated with maternal serum glucose concentrations during pregnancy, mode of delivery and child BMI at 5 years of age. Diet and lifestyle measures that target maternal glucose levels during pregnancy may have lifelong benefits for children's BMI. Identifying those on an accelerated growth trajectory during fetal life provides a unique opportunity for antenatal and infant interventions that may have long-lasting health benefits.",2020,"Mothers with a fetus on the fastest trajectory had higher antenatal serum glucose levels (p<.05), and were more likely to deliver by cesarean section (59.1 versus 20%, p<.001).",['Data from 781 mother-child pairs from the ROLO longitudinal birth cohort study were analyzed'],['low glycemic index diet'],"['maternal serum glucose concentrations', 'rates of mean child 5-year body mass index (BMI) centiles', 'likely to deliver by cesarean section', 'antenatal serum glucose levels', 'Fetal growth trajectories', 'Abdominal circumference (AC), weight (fetal weight, or birth weight), a standardized proxy for length (femur length or birth length, individually standardized), and AC:length ratio', 'Fetal ultrasound measurements', 'birth weight', 'rates of maternal impaired glucose tolerance', 'recurrence of macrosomia']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2959893', 'cui_str': 'Body mass index centile'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1300812', 'cui_str': 'Femur length (observable entity)'}, {'cui': 'C0419415', 'cui_str': 'Birth length (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}]",,0.022121,"Mothers with a fetus on the fastest trajectory had higher antenatal serum glucose levels (p<.05), and were more likely to deliver by cesarean section (59.1 versus 20%, p<.001).","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Bartels', 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Segurado', 'Affiliation': 'Centre for Support and Training in Analysis and Research (CSTAR), School of Public Health, Physiotherapy and Population Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Mason', 'Affiliation': 'Centre for Support and Training in Analysis and Research and School of Public Health, Physiotherapy and Sports Science, University College Dublin, Ireland, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehegan', 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, National Maternity Hospital, Dublin, Ireland.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1554041']
1373,31650069,Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.,"Chronic musculoskeletal pain in adolescence is a significant public health concern with 3-5% of adolescents suffering from significant pain-related disability. Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment. To address this need, we developed graded exposure treatment for youth with chronic pain (GET Living). We describe the rationale, design, and implementation of a two-group randomized controlled trial (RCT) enhanced with single-case experimental design (SCED) methodology with a sample of 74 adolescents with chronic musculosketal pain and their parent caregivers. GET Living includes education, behavioral exposures, and parent intervention jointly delivered by pain psychology and physical therapy providers. The multidisciplinary pain management control group includes pain psychology delivered education and pain self-management skills training (e.g., relaxation, cognitive skills) and separate physical therapy. Assessments include brief daily diaries (baseline to discharge, 7-days at 3-month and 6-month follow-up), comprehensive in-person evaluations at baseline and discharge, and questionnaire across all time points (baseline, discharge, 3-month and 6-month follow-up). Primary outcome is pain-related fear avoidance. Secondary outcome is functional disability. We also outline all additional outcomes, exploratory outcomes, covariates, and implementation measures. The objective is to offer a mechanism-based, targeted intervention to youth with musculoskeletal pain to enhance likelihood of return to function.",2019,Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment.,"['adolescents with chronic pain (GET Living', 'youth with chronic pain (GET Living', 'children and adolescents', '74 adolescents with chronic musculosketal pain and their parent caregivers']","['multidisciplinary pain management control group includes pain psychology delivered education and pain self-management skills training (e.g., relaxation, cognitive skills) and separate physical therapy', 'single-case experimental design (SCED) methodology', 'Graded exposure treatment']","['pain outcomes', 'brief daily diaries (baseline to discharge, 7-days at 3-month and 6-month follow-up), comprehensive in-person evaluations at baseline and discharge, and questionnaire across all time points (baseline, discharge, 3-month and 6-month follow-up', 'pain-related fear avoidance', 'functional disability', 'Chronic musculoskeletal pain']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]",74.0,0.100904,Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment.,"[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simons', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harrison', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Marissa S', 'Initials': 'MS', 'LastName': 'Heirich', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Loecher', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Derek B', 'Initials': 'DB', 'LastName': 'Boothroyd', 'Affiliation': 'Quantitative Statistical Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Center for Economic Impacts of Genomic Medicine, Department of Economics, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Division of Endocrinology and Diabetes, Diabetes Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Orendurff', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}, {'ForeName': 'Salinda', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Lyons', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100448']
1374,30442716,No relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone.,"Nintedanib and pirfenidone are approved treatments for idiopathic pulmonary fibrosis (IPF). This open-label, two-group trial investigated the pharmacokinetic drug-drug interaction between these two drugs in patients with IPF.Subjects not treated with antifibrotics at screening (group 1, n=20) received a single nintedanib dose (150 mg) followed by pirfenidone (titrated to 801 mg thrice daily) for 3 weeks, with a further single nintedanib dose (150 mg) on the last day (day 23). Subjects treated with pirfenidone at screening (group 2, n=17) continued to receive pirfenidone alone (801 mg thrice daily) for 7 days, then co-administered with nintedanib (150 mg twice daily) for a further 7 days, before single doses of both treatments on day 16.In group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanib area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C max ), respectively. In group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidone AUC and C max , respectively. For all parameters, the 90% confidence intervals included 100%, suggesting similar exposure for administration alone and when co-administered. Both treatments were well tolerated.These data indicate there is no relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when co-administered in IPF patients.",2019,Both treatments were well tolerated.,"['patients with IPF.Subjects not treated with antifibrotics at screening (group 1, n=20', 'idiopathic pulmonary fibrosis (IPF']","['Nintedanib and pirfenidone', 'pirfenidone alone', 'pirfenidone at screening', 'single nintedanib dose (150\u2005mg) followed by pirfenidone']","['gMean ratios', 'tolerated', 'plasma concentration-time curve (AUC) and maximum plasma concentration (C max ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0223088,Both treatments were well tolerated.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Università Cattolica del Sacro Cuore, Fondazione Policlinico A. Gemelli, Rome, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': 'Dept of Respiratory Medicine, University Hospital Southampton and Southampton NIHR Respiratory Biomedical Research Unit, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Huzaifa', 'Initials': 'H', 'LastName': 'Adamali', 'Affiliation': 'Bristol Interstitial Lung Disease Service, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Chaudhuri', 'Affiliation': 'Translational Research Collaboration - Inflammatory Respiratory Disease Centre, Manchester, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Wiebe', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Wind', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Hohl', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Boehringer Ingelheim, Bracknell, UK.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Translational Research Collaboration - Inflammatory Respiratory Disease Centre, Manchester, UK.'}]",The European respiratory journal,['10.1183/13993003.01060-2018']
1375,30523504,Do ultraviolet photos increase sun safe behavior expectations via fear? A randomized controlled trial in a sample of U.S. adults.,"Ultraviolet (UV) photos reveal the world in a different light spectrum, including damage that is caused by UV light. In the context of skin cancer control, UV photos have the potential to communicate fear because they reveal underlying skin damage. U.S. adults (N = 2219) were assigned to a 5 (visual: UV skin damage, sun exposure, sunburn, photoaging, and mole removal) × 3 (replication: three examples of each visual condition) × 4 (efficacy: no efficacy, text only, visual, visual + text) randomized controlled trial. Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations. Compared with other visual conditions separately, only mole removal visuals produced equivalent fear as UV skin damage visuals. Visual efficacy conditions appeared to nullify rather than magnify the indirect path through fear. The results suggest one way UV images impact sun safe behavioral expectations is via fear and that researchers should continue to examine the position of fear in fear appeal theories.",2019,"Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations.","['sample of U.S. adults', 'U.S. adults (N\u2009=\u20092219']","['5 (visual: UV skin damage, sun exposure, sunburn, photoaging, and mole removal)\u2009×\u20093']","['sun safe behavior expectations', 'Visual efficacy conditions']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038814', 'cui_str': 'Sunburn'}, {'cui': 'C0027962', 'cui_str': 'Pigmented Moles'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",2219.0,0.0413624,"Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations.","[{'ForeName': 'Manusheela', 'Initials': 'M', 'LastName': 'Pokharel', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA. pokharel.sh@gmail.com.'}, {'ForeName': 'Katheryn R', 'Initials': 'KR', 'LastName': 'Christy', 'Affiliation': 'School of Journalism and Mass Communication, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Jakob D', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Giorgi', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'John', 'Affiliation': 'School of Communications, Brigham Young University, Provo, USA.'}, {'ForeName': 'Yelena P', 'Initials': 'YP', 'LastName': 'Wu', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9997-5']
1376,30219394,Systolic Stretch Characterizes the Electromechanical Substrate Responsive to Cardiac Resynchronization Therapy.,"OBJECTIVES


In this study, the authors tested the hypotheses that the systolic stretch index (SSI) developed by computer modeling and applied using echocardiographic strain imaging may characterize the electromechanical substrate predictive of outcome following cardiac resynchronization therapy (CRT). They included patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists. They further tested the hypothesis that global longitudinal strain (GLS) has additional prognostic value.
BACKGROUND


Response to CRT is variable. Guidelines favor patient selection by electrocardiographic LBBB with QRS width ≥150 ms.
METHODS


The authors studied 442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction ≤35%, and QRS ≥120 ms. A novel computer program semiautomatically calculated the SSI from strain curves as the sum of posterolateral prestretch percent before aortic valve opening and the septal rebound stretch percent during ejection. The primary endpoint was hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after CRT.
RESULTS


In all patients, high longitudinal SSI (≥ group median of 3.1%) was significantly associated with freedom from the primary endpoint of HF hospitalization or death (hazard ratio [HR] for low SSI: 2.17; 95% confidence interval [CI]: 1.45 to 3.24, p < 0.001) and secondary endpoint of death (HR for low SSI: 4.06; 95% CI: 1.95 to 8.45, p < 0.001). Among the 203 patients with QRS 120 to 149 ms or non-LBBB, those with high longitudinal SSI (≥ group median of 2.6%) had significantly fewer HF hospitalizations or deaths (HR for low SSI: 2.08; 95% CI: 1.27 to 3.41, p = 0.004) and longer survival (HR for low SSI: 5.08; 95% CI: 1.94 to 13.31, p < 0.001), similar to patients with LBBB ≥150 ms. SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
CONCLUSIONS


Systolic stretch by strain imaging characterized the myocardial substrate associated with favorable CRT response, including in the important patient subgroup with QRS width 120 to 149 ms or non-LBBB. GLS had additive prognostic value.",2019,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","['442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction\xa0≤35%, and QRS\xa0≥120 ms', 'patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists', '203 patients with QRS']",['cardiac resynchronization therapy (CRT'],"['secondary endpoint of death', 'HF hospitalization or death', 'HF hospitalizations or deaths', 'hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after\xa0CRT', 'systolic stretch index (SSI', 'longer survival', 'Systolic stretch']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0006384', 'cui_str': 'Bundle-Branch Block'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",442.0,0.0799423,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gorcsan', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri. Electronic address: gorcsan@wustl.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Anderson', 'Affiliation': 'Biostatistics Group, Medtronic Incorporated, Minneapolis, Minnesota.'}, {'ForeName': 'Bhupendar', 'Initials': 'B', 'LastName': 'Tayal', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sugahara', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walmsley', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Lumens', 'Affiliation': ""CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands; L'Institut de Rythmologie et Modélisation Cardiaque (IHU-LIRYC), Université de Bordeaux, Pessac, France.""}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2018.07.013']
1377,31676127,"Re: Brian I. Rini, Thomas Powles, Michael B. Atkins, et al. Atezolizumab plus Bevacizumab Versus Sunitinib in Patients with Previously Untreated Metastatic Renal Cell Carcinoma (IMmotion151): A Multicentre, Open-label, Phase 3, Randomised Controlled Trial. Lancet 2019;393:2404-15: Putting IMmotion into Motion: Personalizing Frontline Treatment for Metastatic Renal Cell Carcinoma.",,2020,,"['Patients with Previously Untreated Metastatic Renal Cell Carcinoma (IMmotion151', 'Metastatic Renal Cell Carcinoma']","['Atezolizumab plus Bevacizumab Versus Sunitinib', 'Lancet 2019;393:2404-15: Putting IMmotion into Motion: Personalizing Frontline Treatment']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0777169', 'cui_str': 'Lancet (physical object)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0293768,,"[{'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: singlan@mskcc.org.'}]",European urology,['10.1016/j.eururo.2019.09.015']
1378,30591354,Health-related Quality of Life for Abiraterone Plus Prednisone Versus Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer: Results from a Phase II Randomized Trial.,"BACKGROUND


Abiraterone and enzalutamide are associated with side effects that may impair health-related quality of life (HRQoL).
OBJECTIVE


To assess patient-reported HRQoL, depression symptoms, and cognitive function for abiraterone versus enzalutamide.
DESIGN, SETTING, AND PARTICIPANTS


We randomized 202 patients in a phase II study of abiraterone versus enzalutamide for first-line treatment of metastatic castration-resistant prostate cancer (ClinicalTrials.gov: NCT02125357).
INTERVENTION


Patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Patient Health Questionnaire-9 (PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments at baseline and on treatment.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


To compare the change in FACT-P scores over time between treatment arms, we used a mixed model for repeated measures (MMRM). For FACT-P domains where there was an interaction between the treatment arm and age, we constructed separate models for patients aged <75 and ≥75yr. We compared the proportion of patients with clinically meaningful change from baseline for FACT-P, and the proportion of patients with an abnormal score and median change from baseline for PHQ-9 and MoCA using Fisher's exact test and Mann-Whitney U test.
RESULTS AND LIMITATIONS


In the MMRM analysis, there was a positive test for interaction in the treatment arm by age for total FACT-P (p=0.048). FACT-P change from baseline over time was better for abiraterone than for enzalutamide in the ≥75-yr model (p=0.003), with no difference in the <75-yr model (p>0.9). A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p=0.013; 39% vs 23%, p=0.015). The distribution of change in PHQ-9 scores from baseline favored abiraterone at weeks 4, 8, and 12. These analyses were not prespecified, and results should be considered to be hypothesis generating.
CONCLUSIONS


Patient-reported outcomes favored abiraterone compared with enzalutamide with differences in FACT-P HRQoL and PHQ-9 depression scores. Differences in the total FACT-P scores were seen only in the elderly patient subgroup.
PATIENT SUMMARY


In this report, we examined the change in patient-reported quality-of-life scores from the start of treatment over time for patients treated with abiraterone versus enzalutamide for metastatic castration-resistant prostate cancer. We found that elderly patients treated with abiraterone had better quality of life over time, with no difference between treatments for the younger subgroup of patients.",2019,"A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p=0.013; 39% vs 23%, p=0.015).","['metastatic castration-resistant prostate cancer', 'Patients with Metastatic Castration-resistant Prostate Cancer', 'We randomized 202 patients in a phase II study of', 'patients aged <75 and ≥75yr', 'elderly patients treated with']","['abiraterone versus enzalutamide', 'Abiraterone Plus Prednisone Versus Enzalutamide', 'abiraterone', 'Patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Patient Health Questionnaire-9']","['total FACT-P scores', 'quality-of-life scores', 'PHQ-9 scores', 'FACT-P HRQoL and PHQ-9 depression scores', 'quality of life', 'PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3496286'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",202.0,0.104514,"A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p=0.013; 39% vs 23%, p=0.015).","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sunderland', 'Affiliation': 'Department of Biostatistics, BC Cancer Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Eigl', 'Affiliation': 'Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Ivanov', 'Affiliation': 'Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Daygen L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'Department of Medical Oncology, BC Cancer Southern Interior, Kelowna, BC, Canada.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'Department of Medical Oncology, BC Cancer Fraser Valley, Surrey, BC, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'Department of Medical Oncology, BC Cancer Island Centre, Victoria, BC, Canada.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'Department of Medical Oncology, BC Cancer Abbotsford Centre, Abbotsford, BC, Canada.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Department of Urological Sciences, The Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Department of Medical Oncology, BC Cancer Vancouver Centre, Vancouver, BC, Canada; Department of Urological Sciences, The Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada. Electronic address: kchi@bccancer.bc.ca.'}]",European urology,['10.1016/j.eururo.2018.12.015']
1379,31606362,Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.,"OBJECTIVES


This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
BACKGROUND


Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
METHODS


The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
RESULTS


Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
CONCLUSIONS


Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).",2019,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","['20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial ', 'trial randomized patients hospitalized for HF to receive', '79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n\xa0=\xa037,883 [77.2%]; black, n\xa0=\xa011,180 [22.8', 'Decompensated Heart\xa0Failure', 'Decompensated Heart Failure', 'non-Hispanic white (n\xa0=\xa01,494) and black (n\xa0=\xa01,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e.,\xa0Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria', 'from May 2007 to August 2010 and was neutral for clinical endpoints']","['nesiritide or placebo', 'Nesiritide']","['30-day readmission', 'blood pressure and higher ejection fraction', 'mortality rates', 'hospital mortality']","[{'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.20658,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: stephen.greene@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Matsouaka', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samman Tahhan', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.011']
1380,31166287,Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension.,"PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.
PURPOSE


The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.
METHODS


Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported.
RESULTS


The mean change in intraocular pressure from baseline to day 84 was -0.49±1.80 mm Hg for preservative-free T2347 and -0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
CONCLUSIONS


Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.",2019,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
","['242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved', '15.7±2.4\u2009mm\u2009Hg overall before inclusion', 'Patients With Open-angle Glaucoma or Ocular Hypertension', '10 countries', 'patients with open-angle glaucoma or ocular hypertension']","['Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops', 'BAK-containing formulation', 'preservative-free alternative T2347 (N=127) or remain on the preserved comparator', 'Preservative-free latanoprost-timolol', 'preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination', 'latanoprost-timolol fixed combination', 'preservative-free latanoprost-timolol fixed combination']","['incidence of adverse events or ocular signs', 'tolerated', 'Intraocular pressure changes', 'noninferior efficacy', 'individual symptoms such as irritation/burning/stinging', 'mean change in intraocular pressure', 'total ocular symptoms score', 'intraocular pressure and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium Chloride'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",242.0,0.207138,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Aptel', 'Affiliation': 'CHU de Grenoble/University Hospital of Grenoble, Université Grenoble Alpes, Grenoble.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Ophthalmology, Mainz University Medical Center, Mainz.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schmickler', 'Affiliation': 'Augen-Zentrum-Nordwest, Augenpraxis Ahaus, Ahaus, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Lavín-Dapena', 'Affiliation': 'Hospital Universitario La Paz, Madrid.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Moreno-Montañés', 'Affiliation': 'Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Żarnowski', 'Affiliation': 'Department of Diagnostics and Microsurgery of Glaucoma, Medical University, Lublin, Poland.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Csutak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Jugaste', 'Affiliation': 'Clinic of Ophthalmology, Tallinn, Estonia.'}, {'ForeName': 'Lāsma', 'Initials': 'L', 'LastName': 'Volksone', 'Affiliation': ""Dr Volksone's Practice in Ophthalmology, Lavolks Ltd, Ri[Combining Macron]ga, Latvia.""}, {'ForeName': 'Yury S', 'Initials': 'YS', 'LastName': 'Astakhov', 'Affiliation': 'Department of Ophthalmology, Academician I.P. Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Coupier', 'Affiliation': ""Centre Hospitalier du Pays d'Aix, Service Ophtalmologie, Aix-en-Provence.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Nordmann', 'Affiliation': 'Ophthalmology, CHNO des Quinze-Vingts, Paris, France.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Stalmans', 'Affiliation': 'Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001248']
1381,30291012,Effects of Intensive Blood Pressure Lowering on Kidney Tubule Injury in CKD: A Longitudinal Subgroup Analysis in SPRINT.,"BACKGROUND


Random assignment to the intensive systolic blood pressure (SBP) arm (<120mmHg) in the Systolic Blood Pressure Intervention Trial (SPRINT) resulted in more rapid declines in estimated glomerular filtration rates (eGFRs) than in the standard arm (SBP<140mmHg). Whether this change reflects hemodynamic effects or accelerated intrinsic kidney damage is unknown.
STUDY DESIGN


Longitudinal subgroup analysis of clinical trial participants.
SETTINGS & PARTICIPANTS


Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2  by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline.
OUTCOMES & MEASUREMENTS


Urine biomarkers of tubule function (β 2 -microglobulin [B2M], α 1 -microglobulin [A1M]), and uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40) at baseline, year 1, and year 4. Biomarkers were indexed to urine creatinine concentration and changes between arms were evaluated using mixed-effects linear models and an intention-to-treat approach.
RESULTS


978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included. Mean age was 72±9 years and eGFR was 46.1±9.4mL/min/1.73m 2  at baseline. Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values were similar across arms at baseline. Compared to the standard arm, eGFR was lower by 2.9 and 3.3mL/min/1.73m 2  in the intensive arm at year 1 and year 4. None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4. Two tubule function markers (B2M and A1M) were 29% (95% CI, 10%-43%) and 24% (95% CI, 10%-36%) lower at year 1 in the intensive versus standard arm, respectively.
LIMITATIONS


Exclusion of persons with diabetes, and few participants had advanced CKD.
CONCLUSIONS


Among participants with CKD in SPRINT, random assignment to the intensive SBP arm did not increase any levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR. These findings support the hypothesis that eGFR declines in the intensive arm of SPRINT predominantly reflect hemodynamic changes rather than intrinsic damage to kidney tubule cells.",2019,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"['Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2  by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline', 'Kidney Tubule Injury in CKD', 'persons with diabetes, and few participants had advanced CKD', '978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included', 'Longitudinal subgroup analysis of clinical trial participants']",['Intensive Blood Pressure Lowering'],"['tubule function markers (B2M and A1M', 'Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values', 'Urine biomarkers of tubule function (β 2 -microglobulin [B2M', 'eGFR', 'levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR', 'uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40', 'intensive systolic blood pressure (SBP']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0022674', 'cui_str': 'Kidney Tubules'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",978.0,0.262057,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Imperial Valley Family Care Medical Group, El Centro, CA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craven', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Department of Medicine, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah; Medical Service, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, CA; Kidney Health Research Collaborative, San Francisco VA Medical Center and University of California, San Francisco, CA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, La Jolla, CA. Electronic address: joeix@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2018.07.015']
1382,29673271,"Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees.","OBJECTIVE


This study sought to evaluate whether a contact-based workplace education program was more effective than standard mental health literacy training in promoting early intervention and support for healthcare employees with mental health issues.
METHOD


A parallel-group, randomised trial was conducted with employees in 2 multi-site Ontario hospitals with the evaluators blinded to the groups. Participants were randomly assigned to 1 of 2 group-based education programs: Beyond Silence (comprising 6 in-person, 2-h sessions plus 5 online sessions co-led by employees who personally experienced mental health issues) or Mental Health First Aid (a standardised 2-day training program led by a trained facilitator). Participants completed baseline, post-group, and 3-mo follow-up surveys to explore perceived changes in mental health knowledge, stigmatized beliefs, and help-seeking/help-outreach behaviours. An intent-to-treat analysis was completed with 192 participants. Differences were assessed using multi-level mixed models accounting for site, group, and repeated measurement.
RESULTS


Neither program led to significant increases in help-seeking or help-outreach behaviours. Both programs increased mental health literacy, improved attitudes towards seeking treatment, and decreased stigmatized beliefs, with sustained changes in stigmatized beliefs more prominent in the Beyond Silence group.
CONCLUSION


Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace. The only difference was a reduction in stigmatized beliefs over time. Additional research is needed to explore the factors that lead to behaviour change.",2018,"CONCLUSION


Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace.","['healthcare employees with mental health issues', 'employees in 2 multi-site Ontario hospitals with the evaluators blinded to the groups', '192 participants', 'with Healthcare Employees']","['contact-based workplace education program', '2 group-based education programs: Beyond Silence (comprising 6 in-person, 2-h sessions plus 5 online sessions co-led by employees who personally experienced mental health issues) or Mental Health First Aid (a standardised 2-day training program led by a trained facilitator', 'standard mental health literacy training', 'Workplace Mental Health Literacy Training']","['mental health knowledge, stigmatized beliefs, and help-seeking/help-outreach behaviours', 'stigmatized beliefs', 'mental health literacy, improved attitudes towards seeking treatment', 'help-seeking or help-outreach behaviours']","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.154314,"CONCLUSION


Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace.","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Moll', 'Affiliation': 'School of Rehabilitation Science, McMaster University, ON, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Departments of Community Health Sciences and Psychiatry, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Stuart', 'Affiliation': ""Department of Public Health Sciences, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'School of Rehabilitation Science, McMaster University, ON, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Kirsh', 'Affiliation': 'Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743718766051']
1383,30376369,Placement of Levonorgestrel Intrauterine Device at the Time of Cesarean Delivery and the Effect on Breastfeeding Duration.,"Objectives:  Studies have shown that immediate postpartum initiation of long-acting reversible contraception (LARC) methods leads to increased utilization of LARC and prevention of unintended pregnancies. It is unclear if immediate postpartum levonorgestrel-releasing intrauterine device (LNG-IUD) insertion has an effect on breastfeeding success.  Study Design:  This study was a secondary analysis of a randomized trial that compared intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean IUD placement with women who planned for interval IUD placement at 6 or more weeks postpartum. This parallel, 1:1, nonblinded randomized trial was conducted between March 2012 and June 2014 at the University of North Carolina Women's Hospital. We recruited pregnant women aged 18-45 years who were undergoing a cesarean delivery and desired an IUD for contraception postpartum.  Results:  We received breastfeeding information from 63 women who desired to use a LNG-IUD. A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement. This remained true after adjusting for age, parity, and ethnicity.  Conclusion:  This study adds to the existing body of evidence that shows that most women are able to successfully breastfeed after immediate postpartum LNG-IUD placement. Women should be encouraged to breastfeed, and the desire to breastfeed should not preclude the initiation of a postplacental IUD. This study provides reassurance that immediate postpartum LNG-IUD placement does not adversely affect breastfeeding; however, more high-quality data are needed on the impact of hormonal IUDs on breastfeeding outcomes.",2018,"A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement.","['March 2012 and June 2014 at the University of North Carolina', '63 women who desired to use a LNG-IUD', ""Women's Hospital"", 'women who underwent intracesarean IUD placement with women who planned for interval IUD placement at 6 or more weeks postpartum', 'pregnant women aged 18-45 years who were undergoing a cesarean delivery and desired an IUD for contraception postpartum']","['intrauterine device (IUD', 'Levonorgestrel Intrauterine Device', 'levonorgestrel-releasing intrauterine device (LNG-IUD) insertion']","['Breastfeeding Duration', 'proportion of women breastfeeding']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",,0.416906,"A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement.","[{'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Levi', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Molly K', 'Initials': 'MK', 'LastName': 'Findley', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Avila', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Bryant', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2018.0060']
1384,25943999,Memory training plus yoga for older adults.,"Previous tests of the SeniorWISE intervention with community-residing older adults that were designed to improve affect and cognitive performance were successful and positively affected these outcomes. In this study, we tested whether adding yoga to the intervention would affect the outcomes. Using a quasiexperimental pre-post design, we delivered 12 hours of SeniorWISE memory training that included a 30-minute yoga component before each training session. The intervention was based on the four components of self-efficacy theory: enactive mastery experience, vicarious experience, verbal persuasion, and physiologic arousal. We recruited 133 older adults between the ages of 53 and 96 years from four retirement communities in Central Texas. Individuals were screened and tested and then attended training sessions two times a week over 4 weeks. A septuagenarian licensed psychologist taught the memory training, and a certified yoga instructor taught yoga. Eighty-three participants completed at least 9 hours (75%) of the training and completed the posttest. Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms. Thirteen individuals advanced from poor to normal memory performance, and seven improved from impaired to poor memory performance; thus, 20 individuals improved enough to advance to a higher functioning memory group. The findings from this study of a memory training intervention plus yoga training show that the benefits of multifactorial interventions had additive benefits. The combined treatments offer a unique model for brain health programs and the promotion of nonpharmacological treatment with the goals of maintaining healthy brain function and boosting brain plasticity.",2015,"Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms.","['133 older adults between the ages of 53 and 96 years from four retirement communities in Central Texas', 'older adults']","['SeniorWISE intervention', 'Memory training plus yoga']","['depressive symptoms', 'memory performance, instrumental activities of daily living, and memory self-efficacy']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337650', 'cui_str': 'Living in retirement community (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",133.0,0.0196284,"Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms.","[{'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'McDougall', 'Affiliation': 'Questions or comments about this article may be directed to Graham J. McDougall Jr., RN PHD FAAN FGSA, at gjmcdougall@ua.edu. He is a Professor and Martha Lucinda Luker Saxon Endowed Chair in Rural Health Nursing, Capstone College of Nursing, The University of Alabama, Tuscaloosa, AL. David E. Vance, PhD MGS, is Associate Director, Center for Nursing Research, School of Nursing, University of Alabama at Birmingham, Birmingham, AL. Ernest Wayde, PhD, is a Clinical Psychologist, Psychology Postdoctoral Fellow, VHA National Center for Organization Development, Cincinnati, OH. Katy Ford, MA, is a PhD Student, Department of Psychology, The University of Alabama, Tuscaloosa, AL. Jeremiah Ross, BSN, is a Staff Nurse, Seton Northwest Hospital, Austin, TX.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Vance', 'Affiliation': ''}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Wayde', 'Affiliation': ''}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000133']
1385,30610210,Hyaluronic acid injection in glans penis for treatment of premature ejaculation: a randomized controlled cross-over study.,"This randomized controlled cross-over study aimed to assess the efficacy and safety of glans penis injection with hyaluronic acid (HA) in treating premature ejaculation (PE). A total of 30 patients with PE were randomly allocated into two groups: group 1 (n = 15) which was subjected to glans penis HA injection and group 2 (n = 15) which was injected with saline as a control then both groups were subjected to follow-up at 1 week and 1 month after injection. These subjects were evaluated by intra-vaginal ejaculation latency time (IELT) and the Arabic validated index of premature ejaculation (AIPE). After a wash-out period, cross-over and re-evaluation of both groups were carried. Additionally, patients with reported improvement after 1 month of HA injection (n = 20) were subjected to extended evaluation by IELT at 3, 6, and 9 months intervals. Two-way repeated measures ANOVA indicated significant improvement after HA in comparison with saline across the follow-up periods (F(1.66: 91.37) = 24.85, p = 0.001). Post-hoc Bonferroni test indicated no significant difference after 1 week period in comparison with baseline IELT, but a significant difference after 1 month of injection in comparison with baseline IELT (p < 0.001) and after 1 week (p < 0.001). After 1 month of HA, IELT increased by a median of 2.6 folds while 1.1 folds increase was observed after 1 month of saline injection. Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002). Reported adverse effects were minimal and self-limited. It could be concluded that glans penis injection with HA for treatment of PE is a safe method that ensures a modest but significant increase in IELT and improves couple sexual satisfaction.",2019,Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002).,"['treating premature ejaculation (PE', '30 patients with PE', 'premature ejaculation']","['glans penis injection with hyaluronic acid (HA', 'glans penis HA injection and group 2 (n\u2009=\u200915) which was injected with saline', 'Hyaluronic acid injection']","['intra-vaginal ejaculation latency time (IELT) and the Arabic validated index of premature ejaculation (AIPE', 'adverse effects', 'Total AIPE scores', 'IELT', 'efficacy and safety']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure (body structure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0566549,Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002).,"[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Alahwany', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed W', 'Initials': 'MW', 'LastName': 'Ragab', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt. dr.wa2el@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Abdallah', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Taymour', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of impotence research,['10.1038/s41443-018-0104-9']
1386,30412448,"Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration.","Purpose:  To evaluate safety and efficacy of the vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab for neovascular age-related macular degeneration.  Methods:  Phase 2, multicenter, randomized, double-masked comparison (REACH study, stage 3). Patients ( n  = 64) received intravitreal injections of abicipar 1 mg or 2 mg at baseline, week 4, and week 8 (3 injections) or ranibizumab 0.5 mg at baseline and monthly (5 injections).  Results:  In the abicipar 1 mg ( n  = 25), abicipar 2 mg ( n  = 23), and ranibizumab ( n  = 16) arms, respectively, least-squares mean best-corrected visual acuity (BCVA) change from baseline was +6.2, +8.3, and +5.6 letters at week 16 (primary endpoint) and +8.2, +10.0, and +5.3 letters at week 20. Least-squares mean central retinal thickness (CRT) reduction from baseline was 134, 113, and 131 μm at week 16 and 116, 103, and 138 μm at week 20. Intraocular inflammation adverse events (AEs), reported in 5/48 (10.4%) abicipar-treated patients, resolved without sustained vision loss or other sequelae.  Conclusions:  Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection). No serious AEs were reported.",2018,"CONCLUSIONS


Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection).","['Neovascular Age-Related Macular Degeneration', 'neovascular age-related macular degeneration']","['intravitreal injections of abicipar 1\u2009mg or 2\u2009mg at baseline', 'Abicipar Pegol (an Anti-VEGF DARPin Therapeutic', 'vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab', 'ranibizumab 0.5\u2009mg at baseline and monthly (5 injections', 'ranibizumab']","['sustained vision loss or other sequelae', 'Intraocular inflammation adverse events (AEs', 'Least-squares mean central retinal thickness (CRT) reduction', 'durability of effect: BCVA and CRT improvements']","[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242210', 'cui_str': 'Binding Proteins'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.4859,"CONCLUSIONS


Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Texas Retina Associates, Arlington, Texas.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina, Abilene, Texas.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Eye Clinic, University of Milan, ""Luigi Sacco"" Hospital, Milan, Italy.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology and Bern Photographic Reading Center, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Cheetham', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hohman', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'López', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2018.0062']
1387,31676953,Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab.,"BACKGROUND


Studies of patients treated with bevacizumab and other vascular epithelial growth factor (VEGF) inhibitors have reported that hypertension adverse events (AEs) are associated with improved overall survival (OS) or progression-free survival (PFS).
OBJECTIVE


Our objective was to evaluate the association between early AEs and survival outcomes for patients treated with ramucirumab, an antibody targeting the VEGF receptor-2 (VEGFR-2), plus FOLFIRI for metastatic colorectal cancer (mCRC).
METHODS


Data from 529 patients treated with ramucirumab plus FOLFIRI for mCRC in the RAISE clinical trial (NCT01183780) were evaluated to see whether early (first 6 weeks of therapy) AEs predicted subsequent OS and PFS. A Cox proportional hazard approach was used to evaluate associations between early AEs and survival outcomes. A secondary analysis between FOLFIRI and placebo was conducted as a sensitivity analysis.
RESULTS


Of 529 patients treated with ramucirumab plus FOLFIRI, 479 were alive and progression free at 6 weeks after commencing therapy. No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02 [95% CI 0.67-1.55]; P = 0.803) or PFS (grade 1-2, HR 0.98 [95% CI 0.74-1.28]; grade 3+, HR 0.93 [95% CI 0.64-1.37]; P = 0.93). However, there was a significant association between diarrhea occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and worse OS (grade 1-2, HR 0.96 [95% CI 0.76-1.20]; grade 3+, HR 2.72 [95% CI 1.67-4.44]; P = 0.001) and PFS (grade 1-2, HR 1.01 [95% CI 0.83-1.23]; grade 3+, HR 2.22 [95% CI 1.43-3.45]; P = 0.005). No other AEs were significantly associated with OS or PFS.
CONCLUSIONS


Ramucirumab-induced hypertension was not associated with improved OS and PFS in patients with mCRC treated with ramucirumab and FOLFIRI, but severe diarrhea was associated with poorer OS and PFS.
CLINICAL TRIAL REGISTRATION


No. NCT01183780.",2019,"No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02","['patients treated with ramucirumab, an antibody targeting the VEGF receptor-2 (VEGFR-2), plus FOLFIRI for metastatic colorectal cancer (mCRC', 'Patients with Metastatic Colorectal Cancer Treated with', '529 patients treated with']","['FOLFIRI and placebo', 'Ramucirumab', 'ramucirumab plus FOLFIRI', 'bevacizumab and other vascular epithelial growth factor (VEGF) inhibitors', 'ramucirumab plus FOLFIRI for mCRC']","['severe diarrhea', 'overall survival (OS) or progression-free survival (PFS', 'OS and PFS', 'hypertension', 'Survival Outcomes', 'PFS', 'diarrhea', 'subsequent OS and PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0378796', 'cui_str': 'Flk-1 Protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",479.0,0.295579,"No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02","[{'ForeName': 'Huezin H', 'Initials': 'HH', 'LastName': 'Lim', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia. lim0654@flinders.edu.au.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Hoi Y', 'Initials': 'HY', 'LastName': 'Yuen', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}]",Targeted oncology,['10.1007/s11523-019-00683-z']
1388,30148660,Attention-Deficit/Hyperactivity Disorder-Related Deficits and Psychostimulant Medication Effects on Comprehension of Audiovisually Presented Educational Material in Children.,"Objective:  We aimed to (1) examine differences in observed visual attention and motor activity, as well as comprehension of a science video between children with and without attention-deficit/hyperactivity disorder (ADHD) and (2) explore if psychostimulant medication improves ADHD behaviors and comprehension of a science video in children with ADHD.  Method:  Children aged 7-11 with ( n  = 91) and without ( n  = 45) ADHD watched a science video and then completed a comprehension test. Then, children with ADHD began a 4-week within-subject, randomized, double-blind crossover trial of methylphenidate (MPH). At post-testing, children were randomized to receive placebo or their optimal dosage, watched another science film, and completed a comprehension test.  Results:  Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video. Mediation models revealed that increased motor activity suppressed between-group differences in comprehension. MPH improved comprehension and visual attention, but not motor activity during the science video.  Conclusion:  Children with ADHD may benefit from MPH to improve comprehension of and sustained attention during audiovisually presented learning material.",2018,"RESULTS


Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video.","['children with ADHD began a 4-week within-subject', 'children with and without attention-deficit/hyperactivity disorder (ADHD) and (2', 'Children aged 7-11 with (n\u2009=\u200991) and without (n\u2009=\u200945) ADHD watched a', 'Children with ADHD', 'Children', 'children with ADHD']","['placebo', 'methylphenidate (MPH', 'psychostimulant medication', 'science video and then completed a comprehension test']","['MPH improved comprehension and visual attention', 'motor activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",,0.218182,"RESULTS


Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Orban', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Tanya A', 'Initials': 'TA', 'LastName': 'Karamchandani', 'Affiliation': 'Department of Rehabilitation Psychology/Neuropsychology, TIRR Memorial Hermann Rehabilitation Network, Houston, Texas.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sidol', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Froehlich', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Brinkman', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Estell', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Akemi E', 'Initials': 'AE', 'LastName': 'Mii', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0006']
1389,31144279,"Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.","BACKGROUND


There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations.
OBJECTIVE


Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge.
DESIGN


Pragmatic, randomized comparative effectiveness trial.
PATIENTS


Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care.
INTERVENTIONS


TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred.
MAIN MEASURES


The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days.
KEY RESULTS


Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
CONCLUSIONS


Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days.
TRIAL REGISTRATION


clinicaltrials.gov identifier NCT03066492.",2019,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","['Vulnerable Population', 'Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area', 'Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care']","['Transitional Care Practice', ""TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source"", 'transitional care practice (TC']","['inpatient admissions', '90-day probability of death or additional hospital encounters', 'additional hospital encounters, and counts of hospital encounters, over 180\xa0days', 'binary indicator of death or additional hospital encounters within 90\xa0days of initial discharge', 'probability of any inpatient admission', 'measures of inpatient admissions']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",490.0,0.412341,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Liss', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. david.liss@northwestern.edu.'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Ackermann', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Finch', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'PCPI Foundation, Chicago, IL, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lancki', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Sheth', 'Affiliation': 'Department of Family and Community Medicine, Cook County Health and Hospitals System, Chicago, IL, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Teter', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schaeffer', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05078-4']
1390,31505665,"Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults.","BACKGROUND


This double-blind study assessed immunogenicity, lot consistency, and safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP).
METHODS


Healthy adults (N = 1197) were randomized 2:2:2:2:1 to receive 1 of 3 consistency lots of rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo. Antibody responses pre-/postvaccination (28 days, 6 months; in a subset [n = 566], months 12, 18, and 24) were measured. post hoc analysis of risk factors associated with arthritis following vaccination was performed.
RESULTS


ZEBOV-GP enzyme-linked immunosorbent assay (ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days (>58-fold) and persisted through 24 months. The 3 manufacturing lots demonstrated equivalent immunogenicity at 28 days. Neutralizing antibody GMTs increased by 28 days in all rVSVΔG-ZEBOV-GP groups, peaking at 18 months with no decrease through 24 months. At 28 days, ≥94% of vaccine recipients seroresponded (ZEBOV-GP ELISA, ≥2-fold increase, titer ≥200 EU/mL), with responses persisting at 24 months in ≥91%. Female sex and a history of arthritis were identified as potential risk factors for the development of arthritis postvaccination.
CONCLUSIONS


Immune responses to rVSVΔG-ZEBOV-GP persisted to 24 months. Immunogenicity and safety results support continued rVSVΔG-ZEBOV-GP development.
CLINICAL TRIALS REGISTRATION


NCT02503202.",2019,(ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days,"['Healthy Adults', 'Healthy adults (N = 1197']","['rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo', 'rVSVΔG-ZEBOV-GP Vaccine', 'recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP', 'Placebo']","['equivalent immunogenicity', 'Neutralizing antibody GMTs', 'Immunogenicity and safety', 'ZEBOV-GP enzyme-linked immunosorbent assay', 'ELISA) geometric mean titers (GMTs) increased postvaccination']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1623048', 'cui_str': 'Vesicular stomatitis virus (organism)'}, {'cui': 'C0949896', 'cui_str': 'Zaire Ebola Virus'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",1197.0,0.27196,(ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days,"[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Onorato', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Grant-Klein', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'NewLink Genetics, Inc., BioProtection Systems, Ames, Iowa.'}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Frans A', 'Initials': 'FA', 'LastName': 'Helmond', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiz241']
1391,29390150,Histo-Blood Group Antigen Phenotype Determines Susceptibility to Genotype-Specific Rotavirus Infections and Impacts Measures of Rotavirus Vaccine Efficacy.,"Background


Lewis and secretor histo-blood group antigens (HBGAs) have been associated with decreased susceptibility to P[8] genotype rotavirus (RV) infections. Efficacy of vaccines containing attenuated P[8] strains is decreased in low-income countries. Host phenotype might impact vaccine efficacy (VE) by altering susceptibility to vaccination or RV diarrhea (RVD). We performed a substudy in a monovalent RV vaccine (RV1) efficacy trial in Bangladesh to determine the impact of Lewis and secretor status on risk of RVD and VE.
Methods


In infants randomized to receive RV1 or no RV1 at 10 and 17 weeks with 1 year of complete active diarrheal surveillance, we performed Lewis and secretor phenotyping and genotyped the infecting strain of each episode of RVD.
Results


A vaccine containing P[8] RV protected secretors and nonsecretors similarly. However, unvaccinated nonsecretors had a reduced risk of RVD (relative risk, 0.53 [95% confidence interval, .36-.79]) mediated by complete protection from P[4] but not P[8] RVs. This effect reduced VE in nonsecretors to 31.7%, compared to 56.2% among secretors, and decreased VE for the overall cohort.
Conclusions


Host HBGA status may impact VE estimates by altering susceptibility to RV in unvaccinated children; future trials should therefore account for HBGA status.
Clinical Trials Registration


NCT01375647.",2018,"However, unvaccinated nonsecretors had a reduced risk of RVD (relative risk, 0.53",['unvaccinated children'],"['\n\n\nLewis and secretor histo-blood group antigens (HBGAs', 'RV1 or no RV1', 'vaccines containing attenuated P[8']",['risk of RVD'],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0005804', 'cui_str': 'Blood Group Antigens'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.158669,"However, unvaccinated nonsecretors had a reduced risk of RVD (relative risk, 0.53","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, 1Department of Pediatrics.'}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Dickson', 'Affiliation': 'Department of Medicine, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ross Colgate', 'Affiliation': 'Department of Medicine, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Diehl', 'Affiliation': 'Department of Medicine, University of Vermont Larner College of Medicine, Burlington.'}, {'ForeName': 'Muhammad Ikhtear', 'Initials': 'MI', 'LastName': 'Uddin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Sharmin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Shahidul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Taufiqur Rahman', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nayak', 'Affiliation': 'Center for Public Health Genomics and Department of Public Health Sciences.'}, {'ForeName': 'Josyf C', 'Initials': 'JC', 'LastName': 'Mychaleckyj', 'Affiliation': 'Center for Public Health Genomics and Department of Public Health Sciences.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Petri', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Medicine, University of Vermont Larner College of Medicine, Burlington.'}]",The Journal of infectious diseases,['10.1093/infdis/jiy054']
1392,30485409,Non-Pharmacological Treatment for Primary Headaches Prevention and Lifestyle Changes in a Low-Income Community of Brazil: A Randomized Clinical Trial.,"BACKGROUND


Primary headaches can be reduced by lifestyle changes, such as stress management and physical activity. However, access to programs focused on behavioral interventions is limited in underserved, poor communities.
OBJECTIVES


We performed a randomized open-label clinical trial to test the therapeutic and behavioral effects of aerobic exercise, relaxation, or the combination of both, in individuals with primary headaches of a small, low-income community of the Brazilian Amazon.
METHODS


Participants were screened from the riverine/rural population, and individuals with primary headache were included. We assessed clinical characteristics and physical activity levels. Interventions were delivery 3 times/week for 6 months. The primary outcome variable was changes in days with headache, while changes in duration of attacks, pain intensity, and physical activity levels were secondary outcomes variables.
RESULTS


Seven hundred and ninety individuals were screened (15.3% of rural/riverine population). Seventy-four participants were randomly assigned to relaxation (n = 25), physical activity orientation program (n = 25), or both (n = 24) interventions. Intention to treat analyses showed all interventions as effective to reduce days with headaches and duration of attacks (both P < .01). Pain intensity was reduced only in relaxation and relaxation + physical activity groups (both P < .01). Physical activity levels increased only in the relaxation + physical activity group (P < .05).
CONCLUSIONS


Non-pharmacological interventions such as physical activity and relaxation are effective for reducing headaches, while combining such interventions promote health behavior toward higher physical activity levels in low-income populations with primary headaches.
CLINICAL TRIAL REGISTRATION NUMBER


SGPP 1544.",2019,Pain intensity was reduced only in relaxation and relaxation + physical activity groups (both P < .01).,"['Seven hundred and ninety individuals were screened (15.3% of rural/riverine population', 'Primary Headaches Prevention and Lifestyle Changes in a Low-Income Community of Brazil', 'individuals with primary headaches of a small, low-income community of the Brazilian Amazon', 'Participants were screened from the riverine/rural population, and individuals with primary headache were included', 'Seventy-four participants']","['aerobic exercise, relaxation', 'physical activity orientation program', 'relaxation']","['clinical characteristics and physical activity levels', 'Physical activity levels', 'Pain intensity', 'headaches and duration of attacks', 'changes in days with headache, while changes in duration of attacks, pain intensity, and physical activity levels']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",74.0,0.0567327,Pain intensity was reduced only in relaxation and relaxation + physical activity groups (both P < .01).,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fernando Prieto Peres', 'Affiliation': 'Instituto do Cérebro, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Prieto Peres Mercante', 'Affiliation': 'Instituto do Cérebro, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Arão', 'Initials': 'A', 'LastName': 'Belitardo de Oliveira', 'Affiliation': 'Instituto do Cérebro, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}]",Headache,['10.1111/head.13457']
1393,30308538,Twenty-four hour versus extended antibiotic administration after surgery in complicated appendicitis: A randomized controlled trial.,"BACKGROUND


Recent investigations noted noninferiority in short-course antimicrobial treatments following source control in abdominal infections. We set out to investigate noninferiority of a short and fixed (24 hours) antibiotic administration compared to extended treatment after source control in complicated appendicitis in a prospective single-center open-label randomized controlled trial.
METHODS


After Institutional Review Board (IRB) approval, all consecutive adult patients (age, ≥ 18 years) with complicated appendicitis including gangrenous appendicitis, perforated appendicitis, and appendicitis with periappendicular abscess between May 2016 and February 2018 were randomly allocated to antibacterial therapy limited to 24 hours (short) vs. >24 hours (extended) administration after appendectomy. Primary outcomes included composite postoperative complications and Comprehensive Complication Index (CCI). Secondary outcome was hospital length of stay (HLOS). Follow-up analysis at 1 month was conducted per intention and per protocol.
RESULTS


A total of 80 patients were enrolled with 39 and 41 cases allocated to the short and the extended therapy group, respectively. Demographic profile and disease severity was similar between the study groups. Overall rate of complications was 17.9% and 29.3% in the short and extended group, respectively (p = 0.23). Mean CCI did not differ between the study groups (p = 0.29). Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
CONCLUSION


In the current prospective randomized investigation, the short (24 hours) antibiotic administration following appendectomy did not result in a worse primary outcome in complicated appendicitis. The short interval administration resulted in a significant reduction in HLOS with a major cost-saving and antibacterial stewardship perspective.
LEVEL OF EVIDENCE


Therapeutic Level IV.",2019,"Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
","['after surgery in complicated appendicitis', '80 patients were enrolled with 39 and 41 cases allocated to the short and the extended therapy group, respectively', 'consecutive adult patients (age, ≥ 18 years) with complicated appendicitis including gangrenous appendicitis, perforated appendicitis, and appendicitis with periappendicular abscess between May 2016 and February 2018']","['antibacterial therapy limited to 24 hours (short) vs. >24 hours (extended) administration after appendectomy', 'extended antibiotic administration']","['hospital length of stay (HLOS', 'Mean CCI', 'Overall rate of complications', 'HLOS', 'composite postoperative complications and Comprehensive Complication Index (CCI', 'Demographic profile and disease severity', 'Hospital length of stay']","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1168273', 'cui_str': 'Gangrenous appendicitis'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",80.0,0.198396,"Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
","[{'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Saar', 'Affiliation': 'From the Division of Acute Care Surgery, Department of Surgery (S.S., M.R., E.H.N., E.L., K.G.I., J.L., P.T.), North Estonia Medical Centre, Tallinn; School of Medicine, University of Tartu (S.S., V.M., A.L., U.L., P.T.), Tartu, Estonia; and Division of Trauma, Hand and Reconstructive Surgery (T.L.), Goethe University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Vladislav', 'Initials': 'V', 'LastName': 'Mihnovitš', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lustenberger', 'Affiliation': ''}, {'ForeName': 'Mariliis', 'Initials': 'M', 'LastName': 'Rauk', 'Affiliation': ''}, {'ForeName': 'Erast-Henri', 'Initials': 'EH', 'LastName': 'Noor', 'Affiliation': ''}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Lipping', 'Affiliation': ''}, {'ForeName': 'Karl-Gunnar', 'Initials': 'KG', 'LastName': 'Isand', 'Affiliation': ''}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Lepp', 'Affiliation': ''}, {'ForeName': 'Andrus', 'Initials': 'A', 'LastName': 'Lomp', 'Affiliation': ''}, {'ForeName': 'Urmas', 'Initials': 'U', 'LastName': 'Lepner', 'Affiliation': ''}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Talving', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002086']
1394,31669427,Using routine blood parameters to anticipate clinical outcomes in invasive aspergillosis.,"OBJECTIVE


In invasive aspergillosis (IA), monitoring response to antifungal treatment is challenging. We aimed to explore if routine blood parameters help to anticipate outcomes following IA.
METHODS


Post hoc secondary analysis of two multicenter randomized trials was performed. The Global Comparative Aspergillosis Study (GCA, n = 123) and the Combination Antifungal Study (CAS, n = 251) constituted the discovery and validation cohorts respectively. The outcome measures were response to treatment and survival to 12 weeks. Interval platelet, galactomannan index (GMI) and C-reactive protein (CRP) levels prior and during antifungal treatment were analysed using logistic regression, Kaplan-Meier survival and receiver operating characteristic (ROC) analyses.
RESULTS


The 12-week survival was 70.7% and 63.7% for the GCA and CAS cohorts respectively. In the GCA cohort, every 10 × 10 9 /L platelet count increase at week 2 and 4 improved 12-week survival odds by 6-18% (odds ratio (OR) 1.06-1.18, 95% confidence interval (CI) 1.02-1.33). Survival odds also improved 13% with every 10 mg/dL CRP drop at week 1 and 2 (OR 0.87, 95% CI 0.78-0.97). In the CAS cohort, week 2 platelet count was also associated with 12-week survival with 10% improved odds for every 10 × 10 9 /L platelet increase (OR, 1.10, 95% CI 1.04-1.15). A GMI drop of 0.1 unit was additionally found to increase the odds of treatment response by 3% at the baseline of week 0 (OR 0.97, 95% CI 0.95-0.99). Week 2 platelet and CRP levels performed better than GMI on ROC analyses for survival (area under ROC curve 0.76, 0.87 and 0.67 respectively). A baseline platelet count higher than 30 × 10 9 /L clearly identified patients with >75% survival probability.
CONCLUSIONS


Higher serial platelets were associated with overall survival while GMI trends were linked to IA treatment response. Routine and simple laboratory indices may aid follow-up of response in IA patients.",2020,"Week 2 platelet and CRP levels performed better than GMI on ROC analyses for survival (area under ROC curve 0.76, 0.87 and 0.67 respectively).","['invasive aspergillosis', 'IA patients']",[],"['12-week survival odds', 'odds of treatment response', 'platelet increase', 'overall survival', 'Survival odds', 'response to treatment and survival', 'Interval platelet, galactomannan index (GMI) and C-reactive protein (CRP) levels', '12-week survival']","[{'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0857460', 'cui_str': 'Platelet count above reference range'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0060961', 'cui_str': 'galactomannan'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.113702,"Week 2 platelet and CRP levels performed better than GMI on ROC analyses for survival (area under ROC curve 0.76, 0.87 and 0.67 respectively).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Dickens', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Lim', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Cook', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Herbrecht', 'Affiliation': 'Department of Oncology and Hematology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Johnson', 'Affiliation': 'Mycology Reference Laboratory, Public Health England National Infection Services, Bristol, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Maertens', 'Affiliation': 'University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Kullberg', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Troke', 'Affiliation': 'The Old Court, Broadstairs, UK.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Marr', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'L Y A', 'Initials': 'LYA', 'LastName': 'Chai', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Health System, Singapore and Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: chailouis@hotmail.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.10.019']
1395,30361241,Short-course regimens of rifapentine plus isoniazid to treat latent tuberculosis infection in older Chinese patients: a randomised controlled study.,"Latent tuberculosis infection (LTBI) management is now a critical component of the World Health Organization's End TB Strategy.In this randomised controlled trial (Chinese Clinical Trial Registry identifier ChiCTR-IOR-15007202), two short-course regimens with rifapentine plus isoniazid (a 3-month once-weekly regimen and a 2-month twice-weekly regimen) were initially designed to be evaluated for rural residents aged 50-69 years with LTBI in China.Due to the increasingly rapid growth and unexpected high frequency of adverse effects, the treatments were terminated early (after 8 weeks for the once-weekly regimen and after 6 weeks for the twice-weekly regimen). In the modified intention-to-treat analysis on the completed doses, the cumulative rate of active disease during 2 years of follow-up was 1.21% (14 out of 1155) in the untreated controls, 0.78% (10 out of 1284) in the group that received the 8-week once-weekly regimen and 0.46% (six out of 1299) in the group that received the 6-week twice-weekly regimen. The risk of active disease was decreased, with an adjusted hazard ratio of 0.63 (95% CI 0.27-1.43) and 0.41 (95% CI 0.15-1.09) for the treatments, respectively. No significant difference was found in the occurrence of hepatotoxicity (1.02% (13 out of 1279)  versus  1.17% (15 out of 1279); p=0.704).The short regimens tested must be used with caution among the elderly because of the high rates of adverse effects. Further work is necessary to test the ultrashort regimens in younger people with LTBI.",2018,No significant difference was found in the occurrence of hepatotoxicity (1.02% (13 out of 1279)  versus  1.17% (15 out of 1279); p=0.704).The short regimens tested must be used with caution among the elderly because of the high rates of adverse effects.,"['older Chinese patients', 'rural residents aged 50-69 years with LTBI in China', 'younger people with LTBI']",['rifapentine plus isoniazid'],"['occurrence of hepatotoxicity', 'cumulative rate of active disease', 'risk of active disease']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1299.0,0.0968961,No significant difference was found in the occurrence of hepatotoxicity (1.02% (13 out of 1279)  versus  1.17% (15 out of 1279); p=0.704).The short regimens tested must be used with caution among the elderly because of the high rates of adverse effects.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Henan', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhongmu, China.'}, {'ForeName': 'Xiangwei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Zisen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhongmu, China.'}, {'ForeName': 'Dakuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhongmu, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Jiaoxia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Diseases Control and Prevention of Zhongmu, Zhongmu, China.'}, {'ForeName': 'Hengjing', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Boxuan', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Zongde', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Xiaoyou', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'MOH Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology and Center for Tuberculosis, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01470-2018']
1396,30561711,"Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017.","BACKGROUND


Patient-reported outcomes (PROs) are commonly included in submissions to the United States Food and Drug Administration (FDA). Open-label designs are frequent in cancer trials. Between-arm differences in PRO missingness may affect results. We sought to compare PRO completion rates between study arms in randomized open-label and double-blind cancer trials.
METHODS


Randomized, controlled trials for oncology and malignant hematology products submitted to the FDA in fiscal years 2007-2017 were identified using internal FDA databases. Applicant study reports were reviewed to assess PRO use and reporting of completion rates. Completion rates were collected for each PRO and compared between arms. Results were summarized using descriptive statistics.
RESULTS


Ninety-six trials for anticancer products from 2007 to 2017 contained PROs. Fifty-one (53.1%) were randomized, controlled trials with useable information on PRO completion. The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms. At six months, seven double-blind trials had gaps of at least 10% in at least one PRO between arms; in four trials, these gaps favored the control arm (median difference = 11.5%, range = 10.0-17.0%). For open-label trials, four trials had such gaps, all of which favored the investigational arm (median difference = 28.5%, range = 10.0-69.0%).
CONCLUSIONS


Among trials that provided interpretable PRO completion information, completion rates were high. Most trials had comparable completion rates between arms. However, when large between-arm completion rate differences existed, differences favoring the experimental arm were more common in open-label trials compared with double-blind trials. Procedures must be put in place to improve reporting of PRO completion and reduce missingness, particularly in open-label trials.",2019,The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms.,"['Ninety-six trials for anticancer products from 2007 to 2017 contained PROs', 'oncology and malignant hematology products submitted to the FDA in fiscal years 2007-2017 were identified using internal FDA databases', 'Fifty-one (53.1']",[],"['Completion rates', 'PRO completion rates', 'PRO use and reporting of completion rates', 'median completion rate']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.580763,The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms.,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Roydhouse', 'Affiliation': 'Oak Ridge Institute for Science and Education (ORISE) Fellow, Silver Spring, MD.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Howie', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djy181']
1397,32408862,Comparison of C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy for nasotracheal intubation in simulated cervical spinal injury: a prospective randomized comparative study.,"BACKGROUND


Immobilization with cervical spine worsens endotracheal intubation condition. Though various intubation devices have been demonstrated to perform well in oral endotracheal intubation, limited information is available concerning nasotracheal intubation (NTI) in patients with cervical spine immobilization. The present study compared the performance of the C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI in patients with simulated cervical spine injuries.
METHODS


This was a prospective, randomized, controlled, study done in a tertiary hospital. Ninety-five patients requiring NTI were included in data analysis: McCoy group (group M, n = 47) or C-MAC D-Blade videolaryngoscope group (group C, n = 48). A Philadelphia neck collar was applied before anesthetic induction to immobilize the cervical spine. Single experienced anesthesiologist performed NTI. The primary outcome was duration of intubation divided by three steps: nose to oropharynx; oropharynx into glottic inlet; and glottic inlet to trachea. Secondary outcomes included glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications.
RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s). Group C required significantly less time for glottic visualization and endotracheal tube placement in the trachea. More patients in group C had CL grade I and higher POGO scores (P <  0.001, for both measures). No difficulty in NTI (modified NIDS = 0) was more in group C than group M. Hemodynamic changes and incidence of complications were comparable between groups.
CONCLUSION


The C-MAC D-Blade videolaryngoscope is an effective tool for NTI in a simulated difficult airway, which improves glottic visualization and shortens intubation time relative to those with McCoy laryngoscope.
TRIAL REGISTRATION


Clinical Research Information Service of the Korea National Institute of Health, Identification number: KCT 0004535, Registered December 10, 2019, Retrospectively registered, http://cris.nih.go.kr.",2020,"RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","['patients with simulated cervical spine injuries', 'Immobilization with cervical spine worsens endotracheal intubation condition', 'simulated cervical spinal injury', 'patients with cervical spine immobilization', 'Ninety-five patients requiring NTI were included in data analysis']","['nasotracheal intubation', 'C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI', 'McCoy', 'C-MAC D-Blade videolaryngoscope group', 'C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy']","['Hemodynamic changes and incidence of complications', 'duration of intubation divided by three steps', 'time for glottic visualization and endotracheal tube placement', 'CL grade', 'Total intubation duration', 'POGO scores', 'glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0432666', 'cui_str': 'Injury of cervical spine'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.119102,"RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","[{'ForeName': 'Kwon Hui', 'Initials': 'KH', 'LastName': 'Seo', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Clinical assistant professor, Department of anesthesiology and pain medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. sumsonyo@gmail.com.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'John', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Jun', 'Affiliation': 'Department of anesthesiology and pain medicine, Kangnam Sacred Heart Hospital, Hallym University School of Medicine, 12, Siheung-daero 187-gil, Yeongdeungpo-gu, Seoul, 07441, Republic of Korea.'}, {'ForeName': 'Minsoo', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Soyoun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}]",BMC anesthesiology,['10.1186/s12871-020-01021-x']
1398,30554300,Translation of basic research in cognitive science to HIV-risk: a randomized controlled trial.,"Many people enrolled in drug diversion programs are not receiving evidence-based prevention for HIV or hepatitis. This study translated basic research from cognitive science to increase screening for infection and condom use in this population. A parallel three-condition randomized trial was conducted in a drug diversion sample (N = 358), comparing a memory practice condition with two active control conditions. Outcomes were condom use frequency and testing for infection (hepatitis B/C, HIV). At 3-month follow-up, participants in the memory practice condition were at least twice as likely (OR = 2.10 or greater, p < .01) to self-report testing compared to those in the control conditions and also reported more frequent condom use compared to a health education condition [B = .37, t(1) = 2.02, p = .02]. Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.",2019,Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.,"['drug diversion sample (N\u2009=\u2009358), comparing a memory practice condition with two active control conditions', 'cognitive science to HIV-risk']",[],"['condom use frequency and testing for infection (hepatitis B/C, HIV']","[{'cui': 'C0680490', 'cui_str': 'Drug diversion'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376542', 'cui_str': 'Cognitive Science'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],"[{'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.0766494,Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.,"[{'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Stacy', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, 675 West Foothill Boulevard, Suite 310, Claremont, CA, 91711-3475, USA. alan.stacy@cgu.edu.'}, {'ForeName': 'Liesl A', 'Initials': 'LA', 'LastName': 'Nydegger', 'Affiliation': 'Department of Kinesiology and Health Education, University of Texas, 2109 San Jacinto Blvd., Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Shono', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1100 NE 45th Street, Suite 300, Box 354944, Seattle, WA, 98195-4944, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9999-3']
1399,30535555,Ultrasound-Guided Bilateral Erector Spinae Block Versus Tumescent Anesthesia for Postoperative Analgesia in Patients Undergoing Reduction Mammoplasty: A Randomized Controlled Study.,"PURPOSE


The aim of this prospective, randomized, double-blind study was to compare the tumescent anesthesia method and erector spinae block with respect to postoperative analgesia consumption, pain scores and patient satisfaction, in patients receiving breast reduction surgery under general anesthesia.
METHODS


The study included 44 females, aged 20-65 years, who were to undergo breast reduction surgery, without adjunctive liposuction on the breast. Using the closed envelope method, the patients were randomly separated into two groups to receive tumescent anesthesia or erector spinae block (ESB). Patients in the ESB group received the block before general anesthesia by a single anesthetist (G.Ö.).
RESULTS


The 24-h tramadol consumption with PCA, which was the primary outcome of the study, was determined to be statistically significantly less in the ESB group (p < 0.001). The NRS scores were compared at 30 min postoperatively and then at 1, 2, 4, 6, 12 and 24 h. At all the measured time points, the pain scores of the ESB group were statistically significantly lower (p < 0.001). Additional analgesia was required by one patient in the ESB group and by seven patients in the tumescent group and was applied as 1 g paracetamol. The requirement for additional analgesia was statistically significantly lower in the ESB group (p < 0.024). Patient satisfaction was statistically significantly better in the ESB group (p < 0.001).
CONCLUSIONS


According to the results of this study, bilateral ESB performed under ultrasound guidance in breast reduction surgery was more effective than tumescent anesthesia concerning postoperative analgesia consumption and pain scores. ESB could be an appropriate, effective and safe postoperative analgesia method for patients undergoing reduction mammoplasty surgery.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,"At all the measured time points, the pain scores of the ESB group were statistically significantly lower (p < 0.001).","['patients undergoing reduction mammoplasty surgery', '44 females, aged 20-65\xa0years, who were to undergo breast reduction surgery, without adjunctive liposuction on the breast', 'Patients Undergoing Reduction Mammoplasty', 'patients receiving breast reduction surgery under general anesthesia']","['Ultrasound-Guided Bilateral Erector Spinae Block Versus Tumescent Anesthesia', 'tumescent anesthesia or erector spinae block (ESB', 'paracetamol', 'ESB']","['requirement for additional analgesia', 'Patient satisfaction', '24-h tramadol consumption', 'Additional analgesia', 'pain scores', 'postoperative analgesia consumption and pain scores', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",44.0,0.10825,"At all the measured time points, the pain scores of the ESB group were statistically significantly lower (p < 0.001).","[{'ForeName': 'Gozen', 'Initials': 'G', 'LastName': 'Oksuz', 'Affiliation': 'Anesthesiology and Reanimation, Kahramanmaraş Sutcu Imam University School of Medicine, Kahramanmaras, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'Plastic, Reconstructive and Aesthetic Surgery, Kahramanmaraş Sutcu Imam University School of Medicine, Kahramanmaras, Turkey. fatmabilgen81@gmail.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Anesthesiology and Reanimation, Kahramanmaraş Sutcu Imam University School of Medicine, Kahramanmaras, Turkey.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Duman', 'Affiliation': 'Plastic, Reconstructive and Aesthetic Surgery, Tokat Gaziosmanpasa University School of Medicine, Tokat, Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Urfalıoglu', 'Affiliation': 'Anesthesiology and Reanimation, Kahramanmaraş Sutcu Imam University School of Medicine, Kahramanmaras, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Bilal', 'Affiliation': 'Anesthesiology and Reanimation, Kahramanmaraş Sutcu Imam University School of Medicine, Kahramanmaras, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-018-1286-8']
1400,30739002,Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.,"OBJECTIVE


Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF.
DESIGN


Pragmatic, parallel group, randomized, controlled, multicenter trial.
SETTING


Non-intensive care wards of tertiary centers.
PATIENTS


Non-ICU ward patients with mild to moderate ARF without an established indication for NIV.
INTERVENTIONS


Patients will be randomized to receive or not receive NIV in addition to best available care.
MEASUREMENTS AND MAIN RESULTS


We will enroll 520 patients, 260 in each group. The primary endpoint of the study will be the development of severe ARF. Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications.
CONCLUSIONS


This trial will help determine whether the early use of NIV in non-ICU wards can prevent progression from mild-moderate ARF to severe ARF.",2019,"Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications.
","['early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards', 'Non-ICU ward patients with mild to moderate ARF without an established indication for NIV', 'early General wArd respiraTory failurE (NAVIGATE', 'Non-intensive care wards of tertiary centers']",['non-invasive ventilation (NIV'],"['development of severe ARF', '28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0085559'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}]",520.0,0.238297,"Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications.
","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cabrini', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Brusasco', 'Affiliation': 'Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Roasio', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Corradi', 'Affiliation': 'Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy; Università degli Studi di Pisa, Pisa, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Nardelli', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Filippini', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Cotticelli', 'Affiliation': 'Department of Anesthesia and Intensive Care, Aurelia Hospital, Roma, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ferrera', 'Affiliation': 'Department of Pneumology, Ospedale Villa Scassi ASL 3 Genovese, Genova, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Antonucci', 'Affiliation': 'Department of Emergency-Urgency Medicine, Ospedale Guglielmo da Saliceto, Piacenza, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Baiardo Redaelli', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lattuada', 'Affiliation': 'Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Colombo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Olper', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ponzetta', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ananiadou', 'Affiliation': 'Department of Anesthesia and Intensive Care, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Monti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Severi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Maj', 'Affiliation': ""Department of Anesthesia and Intensive Care, Sant'Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giardina', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; IRCCS NEUROMED, Pozzilli, IS, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Bristol Heart Institute, University of Bristol, School of Clinical Sciences, Bristol, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gemma', 'Affiliation': 'Department of Anesthesia and Intensive Care - Ospedale Fatebenefratelli (ASST Fatebenefratelli-Sacco), Milan, Italy.'}, {'ForeName': 'Sarah Sophia Michelle', 'Initials': 'SSM', 'LastName': 'Cavallero', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy.'}, {'ForeName': 'Ludhmila Abrahao', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Hospital Siriolibanes, Sao Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Melbourne, Australia; Australian and New Zealand Intensive Care Research Center, Monash University, Melbourne, VIC, Australia; School of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.001']
1401,31668003,Microdermabrasion and topical tacrolimus: A novel combination therapy of vitiligo.,"BACKGROUND


Topical immunomodulators have been successfully used as monotherapy or in combination with other therapeutic modalities in treating vitiligo. To the best of our knowledge, no previous studies have evaluated the combination of tacrolimus 0.03% ointment and microdermabrasion as a therapeutic modality to hasten response time and improve repigmentation rate in vitiligo vulgaris.
AIMS


To explore the efficacy and safety of the combination of MDA and topical tacrolimus (0.03%) as a novel therapeutic approach for stable vitiligo vulgaris.
METHODS


Thirty-five patients with vitiligo were enrolled in this randomized placebo-controlled study. Three vitiligenous patches were chosen in each patient. The first lesion (A) was treated by tacrolimus 0.03% ointment, the second lesion (B) was treated by tacrolimus and microdermabrasion, and the third lesion (C) was treated by petrolatum as a placebo. Treatment course was 3 months, and follow-up was done for three extra months. Vitiligenous patches were assessed at baseline and monthly for 6 months.
RESULTS


Moderate to excellent response was observed in 65.7% of lesions B, compared with 25.8% of lesions A (P = .001). Improvement in VASI score was significantly better in patients treated by the combination therapy (P = .000). Disease duration has a negative impact on therapeutic response. Patients were more satisfied with the combination treatment.
CONCLUSION


Microdermabrasion combined with tacrolimus 0.03% ointment represents a new therapeutic option for the treatment of vitiligo which appears to be an easy, safe, and effective.",2020,Improvement in VASI score was significantly better in patients treated by the combination therapy (P = .000).,"['Thirty-five patients with vitiligo', 'stable vitiligo vulgaris']","['Microdermabrasion and topical tacrolimus', 'placebo', 'MDA and topical tacrolimus', 'tacrolimus']","['efficacy and safety', 'VASI score']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0858681', 'cui_str': 'Vitiligo vulgaris'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0590794,Improvement in VASI score was significantly better in patients treated by the combination therapy (P = .000).,"[{'ForeName': 'Nagwa E', 'Initials': 'NE', 'LastName': 'Abd-Elazim', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Haidy A', 'Initials': 'HA', 'LastName': 'Yassa', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Mahran', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assiut, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13193']
1402,31663855,Cost and Effectiveness of Blended Versus Standard Cognitive Behavioral Therapy for Outpatients With Depression in Routine Specialized Mental Health Care: Pilot Randomized Controlled Trial.,"BACKGROUND


Cognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability.
OBJECTIVE


This pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT.
METHODS


Patients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations.
RESULTS


Blended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects.
CONCLUSIONS


This pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted.
TRIAL REGISTRATION


Netherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12888-014-0290-z.",2019,No significant differences were found between groups for depressive episodes (risk difference [RD],"['Outpatients With Depression in Routine Specialized Mental Health Care', 'Patients', 'depressed patients in specialized mental health care']","['standard CBT', 'standard CBT, blended CBT', 'Cognitive behavioral therapy (CBT', 'Blended CBT', 'blended CBT', 'Blended Versus Standard Cognitive Behavioral Therapy']","['self-assessed depression severity, quality-adjusted life-years (QALYs), and costs', 'Mean societal costs', 'depressive episodes (risk difference [RD', 'probability of being cost-effective', 'Cost and Effectiveness']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",1183.0,0.107875,No significant differences were found between groups for depressive episodes (risk difference [RD],"[{'ForeName': 'Lisa Catharine', 'Initials': 'LC', 'LastName': 'Kooistra', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jenneke Elize', 'Initials': 'JE', 'LastName': 'Wiersma', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Neijenhuijs', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Lokkerbol', 'Affiliation': 'Center of Economic Evaluation, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14261']
1403,30085177,"Allostatic load, a measure of chronic physiological stress, is associated with pregnancy outcomes, but not fertility, among women with unexplained infertility.","STUDY QUESTION


Among infertile women undergoing ovarian stimulation, is allostatic load (AL), a measure of chronic physiological stress, associated with subsequent fertility and pregnancy outcomes?
SUMMARY ANSWER


AL at baseline was not associated with conception, spontaneous abortion or live birth, however, it was significantly associated with increased odds of pre-eclampsia and preterm birth among women who had a live birth in the study.
WHAT IS KNOWN ALREADY


Several studies have linked AL during pregnancy to adverse outcomes including preterm birth and pre-eclampsia, hypothesizing that it may contribute to well-documented disparities in pregnancy and birth outcomes. However, AL biomarkers change over the course of pregnancy, raising questions as to whether gestational AL assessment is a valid measure of cumulative physiologic stress starting long before pregnancy. To better understand how AL may impact reproductive outcomes, AL measurement in the non-pregnant state (i.e. prior to conception) is needed.
STUDY DESIGN, SIZE, DURATION


A secondary data analysis based on data from 836 women who participated in Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), a multi-center, randomized clinical trial of ovarian stimulation conducted from 2011 to 2014.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Ovulatory women with unexplained infertility (ages 18-40) were enrolled and at baseline, biological and anthropometric measures were collected. AL scores were calculated as a composite of the following baseline variables determined a priori: BMI, waist-to-hip ratio, systolic blood pressure, diastolic blood pressure, dehydroepiandrosterone sulfate, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, C-reactive protein and HOMA score. Participants received ovarian stimulation for up to four cycles and if they conceived, were followed throughout pregnancy. We fit multi-variable logistic regression models examining AL (one-tailed and two-tailed) in relation to the following reproductive outcomes: conception, spontaneous abortion, live birth, pre-eclampsia, preterm birth and low birthweight.
MAIN RESULTS AND THE ROLE OF CHANCE


Adjusting for covariates, a unit increase in two-tailed AL score was associated with 62% increased odds of pre-eclampsia (OR: 1.62, 95% CI: 1.14, 2.38) 44% increased odds of preterm birth (OR: 1.44, 95% CI: 1.02, 2.08), and 39% increased odds of low birthweight (OR: 1.39, 95% CI: 0.99, 1.97). The relationship between AL and preterm birth was mediated by pre-eclampsia (P = 0.0003). In one-tailed AL analyses, associations were similar, but slightly attenuated. AL was not associated with fertility outcomes (conception, spontaneous abortion, live birth).
LIMITATIONS, REASONS FOR CAUTION


Results may not be generalizable to fertile women who conceive naturally or women with other types of infertility. Comparisons to previous, related work are difficult because variables included in AL composite measures vary across studies. AL may be indicative of overall poor health, rather than being specific to chronic physiological stress.
WIDER IMPLICATIONS OF THE FINDINGS


Our results suggest that chronic physiological stress may not impact success of ovarian stimulation, however, they confirm and extend previous work suggesting that AL is associated with adverse pregnancy outcomes. Physiological dysregulation due to chronic stress has been proposed as a possible mechanism underlying disparities in birth outcomes, which are currently poorly understood. Assessing biomarkers of physiological dysregulation pre-conception or in early pregnancy, may help to identify women at risk of adverse pregnancy outcomes, particularly pre-eclampsia.
STUDY FUNDING/COMPETING INTEREST(S)


Support for AMIGOS was provided by: U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10HD055925. Support for the current analysis was provided by T32ES007271, R25HD075737, P30ES001247 and P30ES005022. This research was made possible by funding by American Recovery and Reinvestment Act. The content is solely the responsibility of the authors and does not necessarily represent the official views of NICHD, NIEHS or NIH. E.B., W.V., O.M., R.A., M.R., V.B., G.W.B., C.C., E.E., S.K., R.U., P.C, H.Z., N.S. and S.T. have nothing to disclose. R.L. reported serving as a consultant to Abbvie, Bayer, Kindex, Odega, Millendo and Fractyl and serving as a site investigator and receiving grants from Ferring. K.H. reported receiving grants from Roche Diagnostics and Ferring. R.R. reported a grant from AbbVie. M.D. reported being on the Board of Directors of and a stockholder in Advanced Reproductive Care.
TRIAL REGISTRATION NUMBER


Clinical Trials.gov number: NCT01044862.",2018,"SUMMARY ANSWER


AL at baseline was not associated with conception, spontaneous abortion or live birth, however, it was significantly associated with increased odds of pre-eclampsia and preterm birth among women who had a live birth in the study.
","['infertile women undergoing', 'women with unexplained infertility', 'Ovulatory women with unexplained infertility (ages 18-40', 'fertile women who conceive naturally or women with other types of infertility', '836 women who participated in Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), a multi-center, randomized clinical trial of ovarian stimulation conducted from 2011 to 2014']",['ovarian stimulation'],"['conception, spontaneous abortion or live birth', 'AL scores', 'fertility outcomes (conception, spontaneous abortion, live birth', 'preterm birth ', 'spontaneous abortion, live birth, pre-eclampsia, preterm birth and low birthweight', 'odds of low birthweight', 'priori: BMI, waist-to-hip ratio, systolic blood pressure, diastolic blood pressure, dehydroepiandrosterone sulfate, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, C-reactive protein and HOMA score']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0057277', 'cui_str': 'Prasterone Sulfate'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.413484,"SUMMARY ANSWER


AL at baseline was not associated with conception, spontaneous abortion or live birth, however, it was significantly associated with increased odds of pre-eclampsia and preterm birth among women who had a live birth in the study.
","[{'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Barrett', 'Affiliation': 'Department of Epidemiology, Environmental and Occupational Health Sciences Institute, Rutgers School of Public Health, 170 Frelinghuysen Road, Piscataway, NJ, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Vitek', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Rochester, NY, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mbowe', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Avenue, Rochester, NY, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Thurston', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Avenue, Rochester, NY, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State University College of Medicine, 500 University Drive, Hershey, PA, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert School of Medicine, Brown University, 90 Plain Street, Providence, RI, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Baker', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, 1195 West Fremont Avenue, Sunnyvale, CA, USA.'}, {'ForeName': 'G Wright', 'Initials': 'GW', 'LastName': 'Bates', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, 111 Colchester Avenue, Burlington, VT, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3701 Market Street, Philadelphia, PA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Bethesda, MD, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, 825 NE 10th Street, Oklahoma City, OK, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology, Center for Molecular Medicine and Genetics, Wayne State University School of Medicine, 275 E. Hancock, Detroit, MI, USA.'}, {'ForeName': 'Randal', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Drive, San Antonio, TX, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Rosen', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, University of California, 550 16th Street, San Francisco, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Usadi', 'Affiliation': 'Carolinas Health Care System, 1025 Morehead Medical Drive, Charlotte, NC, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health, 300 George Street, New Haven, CT, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, 12631 E 17th Avenue, Aurora, CO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, 1120 15th Street, Augusta, GA, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey261']
1404,32408868,Strategies for evaluating self-efficacy and observed success in the practice of yoga postures for therapeutic indications: methods from a yoga intervention for urinary incontinence among middle-aged and older women.,"BACKGROUND


Most clinical investigations involving yoga lack adequate description of the specific yoga elements, including physical postures. Few studies have measured self-efficacy regarding the performance of yoga postures or assessed observed success in performing postures.
METHODS


We developed and piloted several tools to evaluate self-efficacy and observed success in practicing yoga in the context of a randomized feasibility trial of an Iyengar-based yoga intervention for urinary incontinence in ambulatory women ≥50 years. At the end of the 12-week yoga intervention involving twice weekly group yoga classes and once weekly home practice, participants rated their self-efficacy in performing each of the included 15 yoga postures on a 5-point Likert scale. During the 12th week, an expert yoga consultant observed participants and rated their competency in performing postures on a 5-point scale. Participants completed a questionnaire about self-efficacy in adhering to home yoga practice. We examined the distribution of and correlations between scores on the above measures.
RESULTS


Among 27 participants (mean age 65 years), the range of means for self-efficacy ratings for individual postures was 3.6 to 4.5. The range of means for observed competency ratings for individual postures was 3.3 to 5.0. Mean self-efficacy rating for confidence in adhering to the assigned once-weekly home yoga practice was 2.8 (range 1 to 5). Posture self-efficacy was inversely correlated with participant age (p = 0.01) and positively correlated with self-reported physical function (p = 0.03) and mobility (p = 0.01). No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
CONCLUSIONS


These measures hold promise for advancing yoga research and practice by describing methods to: 1) measure self-efficacy in performing specific yoga postures; 2) use an expert observer to assess participants' competence in performing yoga postures; and 3) measure self-efficacy in adhering to home practice. These proposed measures can be used to describe specific components of yoga interventions, to assess whether study participants are able to learn to practice physical aspects of yoga and/or maintain this practice over time, as well as to investigate relationships between self-efficacy and competency in performing yoga postures to achieve specific health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02342678, January 21, 2015.",2020,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","['27 participants (mean age 65\u2009years', 'urinary incontinence among middle-aged and older women', 'ambulatory women ≥50\u2009years']","['practicing yoga', 'Iyengar-based yoga intervention', 'yoga intervention']","['Posture self-efficacy', 'physical function', 'posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores', 'range of means for self-efficacy ratings for individual postures', 'Mean self-efficacy rating']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0380961,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","[{'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Nicosia', 'Affiliation': 'Division of Geriatrics and Institute for Health & Aging, University of California, San Francisco, USA. Francesca.nicosia@ucsf.edu.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Center for Tobacco Control Research and Education and Division of General Internal Medicine, University of California San Francisco, 530 Parnassus, Ste 366, San Francisco, CA, 94143-1390, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Chesney', 'Affiliation': 'Department of Medicine and Osher Center for Integrative Medicine, University of California San Francisco, 1545 Divisadero, San Francisco, CA, 94118, USA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, 300 Pasteur Drive, HG332, Office #G-303A, Stanford, California, 94305-5317, USA.'}, {'ForeName': 'Traci M', 'Initials': 'TM', 'LastName': 'Plaut', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, Street Suite 201, Sutter, 2320, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, 1545 Divisadero Street, San Francisco, CA, 94118, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02934-3']
1405,30466550,Raja yoga meditation and medication-assisted treatment for relapse prevention: A pilot study.,"The continued need for advancement in evidence-based SUD treatment, as well as increases in treatment expense and decline in support from insurance providers, suggest that brief, innovative, and affordable treatments are needed. Meditation, spirituality, and adherence to medication-assisted treatments have all been shown to support abstinence. The current trial assessed effects of spiritually-based meditation, versus relaxation or standard treatment, on substance abstinence and psychological distress and dysfunction in a partially buprenorphine-supported (41.5%) treatment sample. Participants (N = 40) were recruited from an intensive outpatient treatment program, in which three treatment locations acted as separate experimental conditions. Abstinence was measured through urinalyses at baseline and weekly thereafter for the duration of the intervention. Psychological distress and dysfunction were assessed with a Likert-scaled questionnaire measuring symptoms typically associated with SUD. Co-varying for buprenorphine use, participants in the Meditation condition had better odds of remaining abstinent than participants in the Treatment-as-Usual (TAU) and Relaxation conditions. There were no significant differences in substance abstinence between the Relaxation and TAU conditions. Further, co-varying out baseline there were no significant differences at post-course in psychological distress and dysfunction between the three conditions. Results from this pilot trial suggest that this spiritually-informed approach may offer additive support to individuals in SUD treatment, as an aid to the meditative aspect of the 12 steps, or a non-12-step alternative spiritual supplement to standard SUD treatment.",2019,"Co-varying for buprenorphine use, participants in the Meditation condition had better odds of remaining abstinent than participants in the Treatment-as-Usual (TAU) and Relaxation conditions.","['Participants (N\u202f=\u202f40) were recruited from an intensive outpatient treatment program, in which three treatment locations acted as separate experimental conditions']","['spiritually-based meditation, versus relaxation or standard treatment', 'buprenorphine', 'Raja yoga meditation and medication-assisted treatment']","['substance abstinence and psychological distress and dysfunction', 'psychological distress and dysfunction', 'substance abstinence', 'Psychological distress and dysfunction']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150277'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0034641', 'cui_str': 'Raja'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",40.0,0.054546,"Co-varying for buprenorphine use, participants in the Meditation condition had better odds of remaining abstinent than participants in the Treatment-as-Usual (TAU) and Relaxation conditions.","[{'ForeName': 'Debesh', 'Initials': 'D', 'LastName': 'Mallik', 'Affiliation': 'University of Louisiana at Lafayette, P.O. Box 43644, Lafayette, LA 70504, United States of America. Electronic address: debeshmallik@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Pacific University, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Perkins', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sandoz', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.10.012']
1406,30442034,The LOOP Estimator: Adjusting for Covariates in Randomized Experiments.,"BACKGROUND


When conducting a randomized controlled trial, it is common to specify in advance the statistical analyses that will be used to analyze the data. Typically, these analyses will involve adjusting for small imbalances in baseline covariates. However, this poses a dilemma, as adjusting for too many covariates can hurt precision more than it helps, and it is often unclear which covariates are predictive of outcome prior to conducting the experiment.
OBJECTIVES


This article aims to produce a covariate adjustment method that allows for automatic variable selection, so that practitioners need not commit to any specific set of covariates prior to seeing the data.
RESULTS


In this article, we propose the ""leave-one-out potential outcomes"" estimator. We leave out each observation and then impute that observation's treatment and control potential outcomes using a prediction algorithm such as a random forest. In addition to allowing for automatic variable selection, this estimator is unbiased under the Neyman-Rubin model, generally performs at least as well as the unadjusted estimator, and the experimental randomization largely justifies the statistical assumptions made.",2018,"In addition to allowing for automatic variable selection, this estimator is unbiased under the Neyman-Rubin model, generally performs at least as well as the unadjusted estimator, and the experimental randomization largely justifies the statistical assumptions made.",[],[],[],[],[],[],,0.0218524,"In addition to allowing for automatic variable selection, this estimator is unbiased under the Neyman-Rubin model, generally performs at least as well as the unadjusted estimator, and the experimental randomization largely justifies the statistical assumptions made.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Johann A', 'Initials': 'JA', 'LastName': 'Gagnon-Bartsch', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}]",Evaluation review,['10.1177/0193841X18808003']
1407,30351167,Sex-related response to bivalirudin and unfractionated heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention: A subgroup analysis of the VALIDATE-SWEDEHEART trial.,"AIMS


Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients.
METHODS


This study was a prespecified analysis of the Bivalirudin versus Heparin in ST-Segment and Non ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days.
RESULTS


There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26),  p  for interaction 0.05). The observed difference was primarily due to lower risk of major bleeding (Bleeding Academic Research Consortium definition 2, 3 or 5) associated with bivalirudin in women (8.9% vs 11.8%, hazard ratio 0.74 (0.54-1.01)) but not in men (8.5% vs 7.3%, hazard ratio 1.16 (0.94-1.43) in men,  p  for interaction 0.02). Conversely, no significant difference in the risk of Bleeding Academic Research Consortium 3 or 5 bleeding, associated with bivalirudin, was found in women 4.5% vs 5.4% (hazard ratio 0.84 (0.54-1.31)) or men 2.9% vs 2.1% (hazard ratio 1.36 (0.93-1.99)). Bleeding Academic Research Consortium 2 bleeding occurred significantly less often in women assigned to bivalirudin than to unfractionated heparin. The risk of death or myocardial infarction did not significantly differ between randomised treatments in men or women.
CONCLUSION


In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.",2019,"There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05).","['men or women', 'patients with acute myocardial infarction undergoing percutaneous coronary intervention', 'acute myocardial infarction patients', 'patients with myocardial infarction']","['bivalirudin and unfractionated heparin', 'percutaneous coronary intervention', 'Bivalirudin versus Heparin', 'unfractionated heparin', 'bivalirudin', 'bivalirudin or unfractionated heparin']","['risk of Bleeding Academic Research Consortium 3 or 5 bleeding', 'composite of death, myocardial infarction or major bleeding at 180 days', 'risk of death or myocardial infarction']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.23806,"There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sederholm Lawesson', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Medicine, Karolinska Institute, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Robertsson', 'Affiliation': 'Department of Cardiology, Södra Älvsborgs Sjukhus, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Götberg', 'Affiliation': 'Department of Cardiology, Skåne University Hospital, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Skåne University Hospital, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Swahn', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618803760']
1408,30351169,A Randomized Trial of Prenatal Video Education to Improve Breastfeeding Among Low-Income Women.,"Background:  Many women initiate breastfeeding but do not meet their duration goals, and low-income women initiate and continue breastfeeding at lower rates than their counterparts. One-on-one counseling is associated with increased breastfeeding but requires significant resources. In contrast, video education, which requires fewer resources and is effective in other health care settings, such as vaccine uptake, has gone untested for prolonging breastfeeding duration among low-income women.  Objective:  To determine whether use of an educational breastfeeding video shown individually to low-income pregnant women in the prenatal clinic would prolong duration of any and exclusive breastfeeding.  Methods:  A multicenter, randomized, controlled trial was conducted in four prenatal clinics. Low-income pregnant women were randomized to view the intervention (breastfeeding education) or control (prenatal nutrition) video in the third trimester and interviewed by telephone at 1, 3, and 6 months postpartum about infant feeding practices. Kaplan-Meier survival curves with log-rank tests and Cox proportional hazards regression were utilized to compare groups.  Results:  Of the 816 eligible women approached, 64% participated: 263 assigned to the intervention, and 259 assigned to the control. Six-month data were obtained for 211 (80%) and 220 (85%) women, respectively. Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively).  Conclusion:  A single viewing of a breastfeeding education video shown in the prenatal clinic did not impact breastfeeding duration or exclusivity among low-income women in this study. Although not sufficient alone, educational videos may be useful as one component of a comprehensive program to promote breastfeeding.",2018,"Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively).
","['four prenatal clinics', '816 eligible women approached', 'Low-Income Women', 'low-income pregnant women in the prenatal clinic', 'Low-income pregnant women']","['intervention (breastfeeding education) or control (prenatal nutrition) video in the third trimester and interviewed by telephone', 'Prenatal Video Education', 'educational breastfeeding video']","['Kaplan-Meier survival curves', 'Rate of breastfeeding cessation']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0418914', 'cui_str': 'Lactation education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]",816.0,0.0894403,"Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively).
","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Kellams', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Gurka', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Paige P', 'Initials': 'PP', 'LastName': 'Hornsby', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Drake', 'Affiliation': 'School of Nursing, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2018.0115']
1409,30711664,A brief intervention to increase uptake and adherence of an online program for depression and anxiety: Protocol for the Enhancing Engagement with Psychosocial Interventions (EEPI) Randomized Controlled Trial.,"BACKGROUND


There is substantial evidence that psychosocial programs delivered online can be effective in treating and preventing mental health problems. However, use of evidence-based programs in the community is currently suboptimal, and there is a lack of evidence around how to increase engagement with existing evidence-based programs. Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation.
AIMS


The aims of this study are to 1) examine the effectiveness of a brief online engagement-facilitation intervention (EFI) presented prior to an online self-help mental health program (myCompass) in improving uptake of and adherence to that program, and 2) assess if greater uptake and/or adherence are associated with improved efficacy (greater reduction in symptoms of depression and anxiety) relative to a control condition).
METHODS


A three-arm randomized controlled trial will be conducted (target sample: N = 693 participants recruited via social media). An active online cognitive behavioral therapy (iCBT) intervention will be delivered either with (arm 1) or without (arm 2) the EFI. An attention control group (arm 3) will enable testing of the relative efficacy of the iCBT intervention. Primary outcomes are uptake of the intervention (initiation) and adherence (module completion).
RESULTS


Findings will inform the more efficient dissemination of a range of psychosocial programs into the community, with potential for significant efficiency gains in treating common mental health problems.
CONCLUSIONS


Greater engagement with online psychosocial programs may lead to significant reductions in the burden of common mental health problems in the community.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001565235.",2019,"Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation.
",['sample: N\u202f=\u202f693 participants recruited via social media'],"['iCBT intervention', 'active online cognitive behavioral therapy (iCBT) intervention', 'Psychosocial Interventions (EEPI', 'brief online engagement-facilitation intervention (EFI) presented prior to an online self-help mental health program (myCompass']",['uptake of the intervention (initiation) and adherence (module completion'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]",693.0,0.224565,"Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation.
","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia. Electronic address: philip.batterham@anu.edu.au.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sunderland', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kay-Lambkin', 'Affiliation': 'Priority Research Centre for Brain and Mental Health, University of Newcastle, Australia.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Farrer', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Gulliver', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.015']
1410,30523161,Human diaphragm atrophy in amyotrophic lateral sclerosis is not predicted by routine respiratory measures.,"Amyotrophic lateral sclerosis (ALS) patients show progressive respiratory muscle weakness leading to death from respiratory failure. However, there are no data on diaphragm histological changes in ALS patients and how they correlate with routine respiratory measurements.We collected 39 diaphragm biopsies concomitantly with laparoscopic insertion of intradiaphragmatic electrodes during a randomised controlled trial evaluating early diaphragm pacing in ALS (https://clinicaltrials.gov; NCT01583088). Myofibre type, size and distribution were evaluated by immunofluorescence microscopy and correlated with spirometry, respiratory muscle strength and phrenic nerve conduction parameters. The relationship between these variables and diaphragm atrophy was assessed using multivariate regression models.All patients exhibited significant slow- and fast-twitch diaphragmatic atrophy. Vital capacity (VC), maximal inspiratory pressure, sniff nasal inspiratory pressure (SNIP) and twitch transdiaphragmatic pressure did not correlate with the severity of diaphragm atrophy. Inspiratory capacity (IC) correlated modestly with slow-twitch myofibre atrophy. Supine fall in VC correlated weakly with fast-twitch myofibre atrophy. Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.Routine respiratory tests are poor predictors of diaphragm structural changes. Improved detection of diaphragm atrophy is essential for clinical practice and for management of trials specifically targeting diaphragm muscle function.",2019,"Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.","['ALS patients', 'Amyotrophic lateral sclerosis (ALS) patients']",['diaphragm biopsies concomitantly with laparoscopic insertion of intradiaphragmatic electrodes'],"['diaphragm histological changes', 'slow- and fast-twitch diaphragmatic atrophy', 'IC, SNIP and functional residual capacity', 'Vital capacity (VC), maximal inspiratory pressure, sniff nasal inspiratory pressure (SNIP) and twitch transdiaphragmatic pressure', 'Inspiratory capacity (IC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0016815', 'cui_str': 'Functional Residual Capacity'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C1720573', 'cui_str': 'Sniff'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach (qualifier value)'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory Capacity'}]",39.0,0.0538725,"Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Guimarães-Costa', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rivals', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Capucine', 'Initials': 'C', 'LastName': 'Morélot-Panzini', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, Paris, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Nierat', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Mai Thao', 'Initials': 'MT', 'LastName': 'Bui', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Unité de Morphologie Neuromusculaire, Institut de Myologie, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Akbar', 'Affiliation': 'CELIS Cell Culture Core Facility, Institut du Cerveau et de la Moelle Épinière, ICM, INSERM U1127, CNRS UMR 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Straus', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Norma Beatriz', 'Initials': 'NB', 'LastName': 'Romero', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Unité de Morphologie Neuromusculaire, Institut de Myologie, Paris, France.'}, {'ForeName': 'Patrick Pierre', 'Initials': 'PP', 'LastName': 'Michel', 'Affiliation': 'CELIS Cell Culture Core Facility, Institut du Cerveau et de la Moelle Épinière, ICM, INSERM U1127, CNRS UMR 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Menegaux', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Chirurgie Générale et Endocrinologique, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salachas', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': 'Jésus', 'Initials': 'J', 'LastName': 'Gonzalez-Bermejo', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Bruneteau', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01749-2018']
1411,29778387,"Major depression, antidepressant use, and male and female fertility.","OBJECTIVE


To determine if maternal major depression (MD), antidepressant use, or paternal MD are associated with pregnancy outcomes after non-IVF fertility treatments.
DESIGN


Cohort study.
SETTING


Clinics.
PATIENT(S)


Participants in two randomized trials: PPCOS II (clomiphene citrate versus letrozole for polycystic ovary syndrome), and AMIGOS (gonadotropins versus clomiphene citrate versus letrozole for unexplained infertility).
INTERVENTION(S)


Female and male partners completed the Patient Health Questionnaire (PHQ-9). Female medication use was collected. PHQ-9 score ≥10 was used to define currently active MD.
MAIN OUTCOME MEASURE(S)


Primary outcome: live birth.
SECONDARY OUTCOMES


pregnancy, first-trimester miscarriage. Poisson regression models were used to determine relative risks after adjusting for age, race, income, months trying to conceive, smoking, and study (PPCOS II versus AMIGOS).
RESULT(S)


Data for 1,650 women and 1,608 men were included. Among women not using an antidepressant, the presence of currently active MD was not associated with poorer fertility outcomes (live birth, miscarriage), but rather was associated with a slightly increased likelihood of pregnancy. Maternal antidepressant use (n = 90) was associated with increased risk of miscarriage, and male partners with currently active MD were less likely to achieve conception.
CONCLUSION(S)


Currently active MD in the female partner does not negatively affect non-IVF treatment outcomes; however, currently active MD in the male partner may lower the likelihood of pregnancy. Maternal antidepressant use is associated with first-trimester pregnancy loss, which may depend upon the type of antidepressant.
CLINICAL TRIAL REGISTRATION NUMBERS


NCT00719186 and NCT01044862.",2018,"Among women not using an antidepressant, the presence of currently active MD was not associated with poorer fertility outcomes (live birth, miscarriage), but rather was associated with a slightly increased likelihood of pregnancy.","['1,650 women and 1,608 men were included', 'Clinics', 'Female and male partners', 'for polycystic ovary syndrome']","['gonadotropins versus clomiphene citrate versus letrozole', 'PPCOS II (clomiphene citrate versus letrozole']","['likelihood of pregnancy', 'live birth', 'poorer fertility outcomes (live birth, miscarriage', 'maternal major depression (MD), antidepressant use, or paternal MD', 'Major depression, antidepressant use, and male and female fertility', 'risk of miscarriage, and male partners with currently active MD', 'Patient Health Questionnaire (PHQ-9', 'pregnancy, first-trimester miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0337493', 'cui_str': 'Paternal (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}]",1650.0,0.150209,"Among women not using an antidepressant, the presence of currently active MD was not associated with poorer fertility outcomes (live birth, miscarriage), but rather was associated with a slightly increased likelihood of pregnancy.","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Evans-Hoeker', 'Affiliation': 'Department of Obstetrics and Gynecology, Virginia Tech Carilion, Carilion Clinic, Roanoke, Virginia. Electronic address: eaevanshoeker@carilionclinic.org.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2018.01.029']
1412,31863582,Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.,"BACKGROUND


People living with HIV in the USA smoke at a rate nearly three times that of the general population, and Black women are disproportionately affected by HIV infection.
PURPOSE


This study was conducted to test the preliminary efficacy of a digital storytelling intervention for smoking cessation in U.S. women living with HIV.
METHODS


Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the control arm viewed an attention-control film in which women talk about living with HIV infection. Participants in both arms received eight weekly video-call counseling sessions focused on smoking cessation and nicotine patches or gum during the same period. Participants were followed on a monthly basis from quit day for 3 months.
RESULTS


Of the 53 participants randomized, four withdrew before receiving any intervention, one dropped out during the intervention, and 48 (90.6%) completed the study. No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) = 2.30, p = .03] than the control arm. Seven day point-prevalence abstinence rates at 3 month follow-up were not found to differ between the two arms. However, the odds of achieving 3 month prolonged abstinence were four times greater (odds ratio = 4.23, 95% confidence interval = 1.10, 16.23) in the treatment arm than the control arm when the analysis was performed with those (n = 49, 92.5%) who received any part of the allotted intervention.
CONCLUSIONS


A digital storytelling intervention seems to be a valuable strategy to enhance the effect of conventional tobacco dependence treatment for women living with HIV. However, the underlying mechanism of the effect of digital storytelling necessitates further investigations in a large RCT.Clinical Trials Registration No. NCT03289676.",2020,No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) =,"['Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the', '53 participants randomized', 'U.S. women living with HIV', 'Women Living With HIV', 'women living with HIV']","['video-call counseling sessions focused on smoking cessation and nicotine patches or gum', 'control arm viewed an attention-control film', 'digital storytelling intervention', 'Digital Storytelling Intervention']","['odds of achieving 3 month prolonged abstinence', 'prevalence abstinence rates']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",53.0,0.102643,No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) =,"[{'ForeName': 'Sun S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Sang A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Mejia', 'Affiliation': 'Department of Psychology, College of Liberal Arts and Sciences, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': 'Phyllis F. Cantor Center, Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Rosanna F', 'Initials': 'RF', 'LastName': 'Demarco', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz062']
1413,30480133,Exploring Older Adults' Video Game Use in the PRISM Computer System.,"Background and Objective


As part of the PRISM (Personal Reminder Information & Social Management) randomized field trial, a large group of older adults ( N  = 150) received a computer system in their home that presented them with the opportunity to play eleven different video games. While researchers have often assessed older adults' gaming preferences and habits through survey data and focus groups, this trial represented a unique opportunity to study gaming behavior ""in the wild"" over an entire year.
Research Design and Methods


We present an exploration of game usage data, individual differences in game preferences and gaming habits, and individual difference predictors of game use.
Results


Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
Discussion and Implications


Findings have implications for designing video games that older adults enjoy, supporting enjoyable and meaningful interactions with video games across the life span, and for designing cognitive, social, and health interventions involving games.",2018,"Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
",['older adults ( N  = 150'],['computer system in their home that presented them with the opportunity to play eleven different video games'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]",[],,0.0282499,"Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
","[{'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Boot', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Jerad H', 'Initials': 'JH', 'LastName': 'Moxley', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Nelson A', 'Initials': 'NA', 'LastName': 'Roque', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Andringa', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Charness', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Czaja', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sharit', 'Affiliation': 'Department of Industrial Engineering, University of Miami, Florida.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Mitzner', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta.'}, {'ForeName': 'Chin Chin', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Rogers', 'Affiliation': 'Kinesiology & Community Health, University of Illinois at Urbana-Champaign.'}]",Innovation in aging,['10.1093/geroni/igy009']
1414,30384767,The Effect of Varying Incentive Amounts on Physician Survey Response.,"A major challenge with surveying physicians is low response. In this article, we present results of an experiment conducted to determine the optimal monetary incentive amount for gaining response from physicians to a short screener survey. Sampled physicians were randomly assigned to three prepaid cash incentive conditions (US$2, US$5, US$10) compared to a control (US$0). This study found using any incentive increased response versus no incentive. The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group. However, we did not find a statistical difference between the $5 and US$10 incentives or between the US$2 and US$5 incentives. In addition, any incentive amount increased the likelihood of early response compared to no incentive. This study builds on previously mixed results about the effects of various incentive amounts and effect on early survey response. These findings provide practical advice for researchers surveying physicians.",2019,The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group.,[],"['prepaid cash incentive conditions (US$2, US$5, US$10) compared to a control (US$0']",['likelihood of early response'],[],"[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.0152771,The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group.,"[{'ForeName': 'HarmoniJoie', 'Initials': 'H', 'LastName': 'Noel', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Huang', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}]",Evaluation & the health professions,['10.1177/0163278718809844']
1415,31863561,Bone marrow-derived mesenchymal stromal cell treatment in patients with ischaemic heart failure: final 4-year follow-up of the MSC-HF trial.,"AIMS


The study assessed 4-year outcomes of intramyocardial injections of autologous bone marrow-derived mesenchymal stromal cells (MSCs) in patients with ischaemic heart failure.
METHODS AND RESULTS


The MSC-HF trial was a randomized, double-blind, placebo-controlled trial. Patients were randomized 2:1 to intramyocardial injections of MSCs or placebo. The primary endpoint was change in left ventricular end-systolic volume (LVESV), measured by magnetic resonance imaging or computed tomography. Sixty patients aged 30-80 years with ischaemic heart failure, New York Heart Association class II-III, left ventricular ejection fraction (LVEF) <45% and no further treatment options were randomized. Patients were followed clinically for 12 months and in addition 4-year data of hospitalizations and survival were retrieved. After 12 months, LVESV was significantly reduced in the MSC group and not in the placebo group, with difference between groups of 17.0 ± 16.2 mL (95% confidence interval 8.3-25.7, P = 0.0002). There were also significant improvements in LVEF of 6.2% (P < 0.0001), stroke volume of 16.1 mL (P < 0.0001) and myocardial mass (P = 0.009) between groups. A significant dose-response effect was also observed. Moreover, a significant reduction in the amount of scar tissue and quality of life score in the MSC group but not in the placebo group was observed. After 4 years, there were significantly fewer hospitalizations for angina in the MSC group and otherwise no differences in hospitalizations or survival. No side effects were identified.
CONCLUSIONS


Intramyocardial injections of autologous bone marrow-derived MSCs improved myocardial function and myocardial mass in patients with ischaemic heart failure.",2020,"After 4 years, there were significantly fewer hospitalizations for angina in the MSC group and otherwise no differences in hospitalizations or survival.","['Sixty patients aged 30-80\u2009years with ischaemic heart failure, New York Heart Association class II-III, left ventricular ejection fraction (LVEF', 'patients with ischaemic heart failure']","['Bone marrow-derived mesenchymal stromal cell treatment', 'autologous bone marrow-derived mesenchymal stromal cells (MSCs', 'placebo', 'MSCs or placebo', 'autologous bone marrow-derived MSCs']","['hospitalizations and survival', 'hospitalizations or survival', 'myocardial mass', 'stroke volume', 'hospitalizations for angina', 'LVEF', 'myocardial function and myocardial mass', 'amount of scar tissue and quality of life score', 'change in left ventricular end-systolic volume (LVESV), measured by magnetic resonance imaging or computed tomography', 'LVESV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2004491', 'cui_str': 'Scars'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]",60.0,0.50003,"After 4 years, there were significantly fewer hospitalizations for angina in the MSC group and otherwise no differences in hospitalizations or survival.","[{'ForeName': 'Anders B', 'Initials': 'AB', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Abbas A', 'Initials': 'AA', 'LastName': 'Qayyum', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Haack-Sørensen', 'Affiliation': 'Cardiac Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ekblond', 'Affiliation': 'Cardiac Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",European journal of heart failure,['10.1002/ejhf.1700']
1416,31665912,Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomized controlled trial.,"The objective of this study was to compare standard treatment versus the combination of intrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT) before and after ASC in the metabolic control of patients with type 2 diabetes mellitus (T2DM). This study was a prospective, randomized controlled trial. The combined intervention consisted of 10 sessions of HBOT before the intrapancreatic infusion of ASC and 10 sessions afterwards. ASCs were infused into the main arterial supply of the pancreas to maximize the presence of the stem cells where the therapeutic effect is most desired. A total of 23 patients were included (control group = 10, intervention group = 13). Age, gender, diabetes duration, number of medications taken, body weight and height, and insulin requirements were recorded at baseline and every three months. Also, body mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR) were measured every three months for one year. HbA1c was significantly lower in the intervention group compared with control throughout follow-up. Overall, 77% of patients in the intervention group and 30% of patients in the control group demonstrated a decrease of HbA1c at 180 days (compared with baseline) of at least 1 unit. Glucose levels were significantly lower in the intervention group at all timepoints during follow-up. C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  = 0.0021. CPGR was higher in the intervention group at all controls during follow-up. The requirement for insulin was significantly lower in the intervention group at 90, 180, 270, and 365 days. Combined therapy of intrapancreatic ASC infusion and HBOT showed increased metabolic control and reduced insulin requirements in patients with T2DM compared with standard treatment.",2019,"C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  ","['A total of 23 patients were included (control group = 10, intervention group = 13', 'patients with T2DM', 'type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy', 'intrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT', 'intrapancreatic ASC infusion and HBOT']","['body mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR', 'HbA1c', 'Age, gender, diabetes duration, number of medications taken, body weight and height, and insulin requirements', 'metabolic control and reduced insulin requirements', 'CPGR', 'requirement for insulin', 'C-peptide levels', 'Glucose levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0442099,"C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  ","[{'ForeName': 'Esteban J', 'Initials': 'EJ', 'LastName': 'Estrada', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Decima', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bortman', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Roberti', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Elida Beatriz', 'Initials': 'EB', 'LastName': 'Romero', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Samaja', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Aldo Rodríguez', 'Initials': 'AR', 'LastName': 'Saavedra', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Martínez', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Gutiérrez', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}]",Cell transplantation,['10.1177/0963689719883813']
1417,31664632,Clinical efficacy of an Aloe Vera gel versus a 0.12% chlorhexidine gel in preventing traumatic ulcers in patients with fixed orthodontic appliances: a double-blind randomized clinical trial.,"Traumatic oral ulceration (TOU) is one of the most common side effects of orthodontic treatments. The objective of this trial is to compare the clinical efficacy of an 80% Aloe Vera gel, prepared using a master formula, versus a commercial 0.12% Chlorhexidine (CHX) gel for TOU prevention in participants wearing fixed orthodontic appliances. This report represents a single-centre, university-based, double-blinded, randomized controlled trial with 2 parallel arms. Patients aged 12 years or older, in the permanent dentition, and about to start fixed orthodontic treatment in this university setting were randomly allocated to use either Aloe Vera or CHX gel, following the cementation procedure. Pre-treatment and 1 month after the cementation clinical assessment and digital photographic images were taken of the teeth and assessed by 2 clinical assessors for the presence or absence of TOUs. A total of 140 were randomized and completed the trial. The overall prevalence of TOUs was 43.6%. Overall 5.7% of patients treated with Aloe Vera gel showed did not suffer from TOUs, whereas in the CHX arm, a total of 57 (81.4%) were affected by this outcome reaching a significant result (p < 0.001). In terms of relative risk (RRs) and confidence intervals (CIs), Aloe Vera provided better results than CHX with an RR of 0.07 (95%CI 0.03-0.16; p < 0.001), and with a patients' number needed to treat of 1.3 (95%CI 1.16-1.54). There were no adverse effects. These results suggest that Aloe Vera gel administration in patients with fixed orthodontic appliances could be important for effective prevention of TOU.",2020,"In terms of relative risk (RRs) and confidence intervals (CIs), Aloe Vera provided better results than CHX with an RR of 0.07 (95%CI 0.03-0.16; p < 0.001), and with a patients' number needed to treat of 1.3 (95%CI 1.16-1.54).","['Patients aged 12\xa0years or older, in the permanent dentition, and about to start fixed orthodontic treatment in this university setting', 'patients with fixed orthodontic appliances', 'participants wearing fixed orthodontic appliances']","['Aloe Vera or CHX gel', 'chlorhexidine gel', '80% Aloe Vera gel', 'Chlorhexidine (CHX) gel for TOU prevention', 'Aloe Vera gel']","['effective prevention of TOU', 'overall prevalence of TOUs', 'relative risk (RRs) and confidence intervals (CIs), Aloe Vera', 'traumatic ulcers', 'Traumatic oral ulceration (TOU', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0974143', 'cui_str': 'Aloe vera gel'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0406226', 'cui_str': 'Traumatic ulcer (morphologic abnormality)'}, {'cui': 'C1274796', 'cui_str': 'Traumatic oral ulceration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",140.0,0.586157,"In terms of relative risk (RRs) and confidence intervals (CIs), Aloe Vera provided better results than CHX with an RR of 0.07 (95%CI 0.03-0.16; p < 0.001), and with a patients' number needed to treat of 1.3 (95%CI 1.16-1.54).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Leiva-Cala', 'Affiliation': 'Clinic of Orthodontics, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.'}, {'ForeName': 'Alejandro Ismael', 'Initials': 'AI', 'LastName': 'Lorenzo-Pouso', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Centenera-Centenera', 'Affiliation': 'Clinic of Orthodontics, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'López-Palafox', 'Affiliation': 'Legal and Forensic Dentistry Unit, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Gándara-Vila', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'García-García', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pérez-Sayáns', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain. mario.perez@usc.es.'}]",Odontology,['10.1007/s10266-019-00468-w']
1418,31660683,Efficacy of a skin care cream with TRPV1 inhibitor 4-t-butylcyclohexanol in the topical therapy of perioral dermatitis.,"BACKGROUND


Perioral dermatitis is a clinically distinctive reaction pattern of facial dermatitis, including redness, dryness, burning, pruritus and skin tightness. A gold standard treatment remains unclear.
OBJECTIVES


Our study evaluates the clinical value of a skin care cream with the transient receptor potential vanilloid type 1 inhibitor 4-t-butylcyclohexanol in POD patients over 8 weeks.
METHODS


This open, unblinded 8-week clinical trial included 48 patients. A skin care cream containing 4-t-butylcyclohexanol was applied over a period of 8 weeks. Standardized questionnaires were used at baseline, 4 and 8 weeks, for history documentation, objective and subjective severity scores, and quality of life assessments. Six different skin physiology parameters were assessed at all timepoints.
RESULTS


The perioral dermatitis severity score decreased significantly during the treatment period. This was mirrored by significantly lower patients' subjective numerical rating score and an improved quality of life score. Transepidermal water loss, stratum corneum hydration and skin erythema improved significantly during the treatment period.
CONCLUSION


This transient receptor potential vanilloid type 1 inhibitor-based skin care cream improved subjective and objective parameters of perioral dermatitis. Decreased transepidermal water loss values and increased stratum corneum hydration demonstrate a restored skin barrier function. Consequently, the topical inhibition of these receptors is a promising management option for POD.",2020,Decreased transepidermal water loss values and increased stratum corneum hydration demonstrate a restored skin barrier function.,"['POD patients over 8\xa0weeks', 'perioral dermatitis', '48 patients']","['skin care cream containing 4-t-butylcyclohexanol', 'skin care cream with TRPV1 inhibitor 4-t-butylcyclohexanol']","['subjective numerical rating score', 'perioral dermatitis severity score', 'quality of life score', 'history documentation, objective and subjective severity scores, and quality of life assessments', 'Transepidermal water loss, stratum corneum hydration and skin erythema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0263449', 'cui_str': 'Perioral Dermatitis'}]","[{'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0263449', 'cui_str': 'Perioral Dermatitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",48.0,0.0204854,Decreased transepidermal water loss values and increased stratum corneum hydration demonstrate a restored skin barrier function.,"[{'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Srour', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Linden', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Zorica', 'Initials': 'Z', 'LastName': 'Jovanovic', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Roggenkamp', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reinholz', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rothenberger', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Gitta', 'Initials': 'G', 'LastName': 'Neufang', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13175']
1419,30442714,Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma.,"Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β 2 -agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS dose of ≤5 mg, those with a ≥50% reduction in prescribed maintenance OCS dose and asthma exacerbation rate. Safety was also assessed.At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271). There were no significant between-treatment differences for any secondary end-point. Overall, reporting of adverse events and serious adverse events were similar for the tralokinumab and placebo groups. Although a greater proportion of tralokinumab-treated patients reported upper respiratory tract infections (35.7%  versus  14.3%), there were no reported cases of pneumonia.Overall, tralokinumab did not demonstrate an OCS-sparing effect in patients with severe asthma.",2019,"At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271).","['patients with severe asthma', '140 patients', 'patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β 2 -agonists']","['OCS-sparing potential of tralokinumab', 'placebo', 'Tralokinumab', 'corticosteroid (OCS', 'tralokinumab 300\u2005mg or placebo']","['OCS-sparing effect', 'upper respiratory tract infections', 'prescribed maintenance OCS dose and asthma exacerbation rate', 'Overall, reporting of adverse events and serious adverse events', 'Safety', 'proportion of patients with a prescribed maintenance OCS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",140.0,0.556496,"At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Dept of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Brusselle', 'Affiliation': 'Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Dept, Mainz University Hospital, Mainz, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Dept of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Magnan', 'Affiliation': 'Institut du Thorax, INSERM CNRS, Université de Nantes, CHU de Nantes, Nantes, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Piechowiak', 'Affiliation': 'AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Millie M', 'Initials': 'MM', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",The European respiratory journal,['10.1183/13993003.00948-2018']
1420,30325237,A pilot study using electronic reminders for amblyopia treatment.,"Treatment compliance is the most important factor for predicting a successful outcome in amblyopia treatment. Electronic applications have been successfully employed in other medical conditions in an effort to improve compliance. Aim : To determine whether a smartphone medical adherence application (app) (RxmindMe® Prescription/Medicine Reminder and Pill Tracker) may be successfully incorporated into the treatment plan of patients 3-7 years of age who have not previously been treated for amblyopia. Methods : Children 3-7 years of age were randomized to receive electronic reminders (reminders group) or standard instructions (control group). Visual acuity and compliance with treatment was assessed at the first follow-up visit. The child's adherence with the prescribed treatment was calculated as the reported number of hours of patching performed divided by the number of hours prescribed or compliance percentage. The validated ""Amblyopia Treatment Index Parental Questionnaire"" was administered to the parent/guardian to assess any differences in the compliance subscale between the two treatment groups. Any difficulties encountered with the use of the reminder app were also recorded at the follow-up visit. Results : Twenty-four participants were enrolled. Twelve participants in the reminder group (eight female, four male; mean age 4.5 ± 1.3) were compared with 12 participants in the control group (five female, seven male; mean 4.8 ± 1.1). No significant differences were found between the two groups in terms of age ( p  = 0.62), gender ( p  = 0.22), or degree of amblyopia at the start of treatment ( p  = 0.99). Eleven of 12 participants in the reminders group were able to incorporate the reminder app into amblyopia treatment. No participant reported malfunction of the alarm portion of the reminder app. There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire. Several participants reported the app to be ""helpful"" in initiating treatment. Conclusion : Our findings indicate that use of a smartphone app is feasible in this patient population. Targeting the app to specific patient demographics or when difficulty with compliance is encountered needs to be further investigated.",2018,"There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire.","['3-7\xa0years of age', 'Twelve participants in the reminder group (eight female, four male; mean age 4.5\xa0±\xa01.3) were compared with 12 participants in the control group (five female, seven male; mean 4.8\xa0±\xa01.1', 'patients 3-7\xa0years of age who have not previously been treated for amblyopia', 'Children', 'Twenty-four participants were enrolled']","['electronic reminders', 'smartphone medical adherence application (app) (RxmindMe® Prescription/Medicine Reminder and Pill Tracker', 'electronic reminders (reminders group) or standard instructions (control group']","['validated ""Amblyopia Treatment Index Parental Questionnaire', 'degree of amblyopia', 'degree of visual acuity improvement', 'Visual acuity and compliance', 'compliance subscale']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",24.0,0.0260685,"There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire.","[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Kammi B', 'Initials': 'KB', 'LastName': 'Gunton', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Schnall', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}]",Strabismus,['10.1080/09273972.2018.1526959']
1421,30319034,The effects of repeatedly recalling a traumatic event on eyewitness memory and suggestibility.,"The aims of this study were to examine the effects of repeatedly recalling a traumatic event on recall performance and eyewitness suggestibility. We also investigated whether these effects were moderated by the type of details recalled and the completeness of retrieval. Participants watched a video depicting a fatal car accident and were randomly allocated to one of four conditions in which they: (1) repeatedly recalled the traumatic (central) details of the event only (trauma-focused); (2) repeatedly recalled the non-traumatic (peripheral) details of the event only (non-trauma focused); (3) repeatedly recalled the entire video (complete); or (4) did not recall the video at all (no-recall control). Results indicated that repeated complete recall was beneficial for memory retention of the entire traumatic event and that, in general, trauma-related (central) post-event information (PEI) was less likely to be reported than trauma-unrelated (peripheral) PEI. It was also found that repeated trauma-focused recall increased trauma-related confabulations. These results not only illustrate the value of repeated complete recall to best preserve the integrity of eyewitness memory, but, perhaps more critically, warn of the dangers of repeatedly questioning witnesses specifically about the central or traumatic details of an event.",2019,"Results indicated that repeated complete recall was beneficial for memory retention of the entire traumatic event and that, in general, trauma-related (central) post-event information (PEI) was less likely to be reported than trauma-unrelated (peripheral) PEI.",['Participants watched a video depicting a fatal car accident'],['four conditions in which they: (1) repeatedly recalled the traumatic (central) details of the event only (trauma-focused); (2) repeatedly recalled the non-traumatic (peripheral) details of the event only (non-trauma focused); (3) repeatedly recalled the entire video (complete); or (4) did not recall the video at all (no-recall control'],['recall performance and eyewitness suggestibility'],"[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1579887', 'cui_str': 'Car accident'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4554227', 'cui_str': 'Repeatedly - dosing instruction fragment'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0233423', 'cui_str': 'Suggestibility, function (observable entity)'}]",,0.0464687,"Results indicated that repeated complete recall was beneficial for memory retention of the entire traumatic event and that, in general, trauma-related (central) post-event information (PEI) was less likely to be reported than trauma-unrelated (peripheral) PEI.","[{'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'a School of Psychology , The University of Sydney , Sydney , Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Paterson', 'Affiliation': 'a School of Psychology , The University of Sydney , Sydney , Australia.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'van Golde', 'Affiliation': 'a School of Psychology , The University of Sydney , Sydney , Australia.'}]","Memory (Hove, England)",['10.1080/09658211.2018.1533563']
1422,30299482,Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial.,"STUDY QUESTION


Does CO2 laser vaporization offer better results in treating endometrioma in terms of ovarian reserve preservation compared to traditional cystectomy?
SUMMARY ANSWER


Assessing both antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) levels as measures of ovarian reserve, the results suggest that CO2 technology may be an alternative treatment for endometrioma, causing minimal damage to adjacent healthy ovarian tissue.
WHAT IS KNOWN ALREADY


Excisional surgery has been questioned as an ideal surgical approach for endometriomas because it is associated with potential reduction of ovarian reserve. Recently, vaporization with CO2 laser in-line-of-sight, according to the 'three-step procedure', has been proposed as the best method to preserve ovarian function. However, no randomized controlled trials have been conducted to compare cystectomy and 'one-step' CO2 fiber laser vaporization (without GnRH agonist therapy) with respect to the ovarian reserve.
STUDY DESIGN, SIZE, DURATION


A multicentre randomized clinical trial including 60 patients was performed between July 2017 and February 2018. Computerized randomization was conducted to allocate them in a proportion of 1:1 either to Group 1 (laparoscopic stripping: cystectomy) or Group 2 (CO2 laser vaporization). Patients in Group 1 underwent a standardized laparoscopic stripping technique; patients in Group 2 underwent drainage of the cyst content, biopsy and vaporization of the internal wall with a CO2 fiber laser. Patients underwent pelvic ultrasound examination to determine the AFC and blood sampling to determine AMH levels before surgery and at 1- and 3-month follow-up.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Patients undergoing surgery for symptomatic endometriomas (infertility and/or pelvic pain) larger than 3 cm were randomized in two groups according to the surgical technique. Patients aged ≥40 years, or with deep infiltrating endometriosis/adenomyosis, or previously submitted to surgical procedures on the ovaries or to hysterectomy were excluded from the study. The primary endpoint was the comparison of intra-group AFC changes before and after surgery (ΔAFC) between the two groups (ΔAFC Group 1 versus ΔAFC Group 2). The secondary endpoint was the modification of serum AMH before and after surgery (ΔAMH) between the two groups (ΔAMH Group 1 versus ΔAMH Group 2).
MAIN RESULTS AND THE ROLE OF CHANCE


The AFC of the operated ovary was significantly increased in Group 2 (laser vaporization) compared with Group 1 (cystectomy) after surgery (Group 1: from 4.1 ± 2.2 [mean ± SD] at baseline to 6.3 ± 3.5 at 3-month follow-up; 95% CI: 0.9-4; Group 2: from 3.6 ± 1.9 at baseline to 8.6 ± 4.2 at 3-month follow-up; 95% CI: 2.8-7.1; P = 0.016); serum AMH levels were significantly reduced at 3 months in Group 1 (from 2.6 ± 1.4 ng/mL at baseline to 1.8 ± 0.8 ng/mL at 3-month follow-up; 95% CI: -1.3 to -0.2; P = 0.012) compared with no reduction in Group 2 (from 2.3 ± 1.1 ng/mL at baseline to 1.9 ± 0.9 ng/mL at 3-month follow-up; 95% CI: -1 to -0.2; P = 0.09).
LIMITATIONS, REASON FOR CAUTION


The key limitations of the trial were the low accuracy of AFC in estimating the ovarian reserve in ovaries with endometriomas, the limited study size and the relatively short follow-up, which do not allow us to draw definitive conclusions.
WIDER IMPLICATIONS OF THE FINDINGS


The present study suggests that CO2 technology may treat endometrioma with minimal damage to the adjacent healthy ovarian tissue; however, this study should be considered as a preliminary clinical trial, intended to stimulate future larger trials to address this clinically relevant issue.
STUDY FUNDING/COMPETING INTEREST(S)


None.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT03227640.
TRIAL REGISTRATION DATE


9 July 2017.
DATE OF FIRST PATIENT’S ENROLLMENT


24 July 2017.",2018,"Does CO2 laser vaporization offer better results in treating endometrioma in terms of ovarian reserve preservation compared to traditional cystectomy?
","['ovarian endometrioma', 'Patients aged ≥40 years, or with deep infiltrating endometriosis/adenomyosis, or previously submitted to surgical procedures on the ovaries or to hysterectomy were excluded from the study', '’S', 'Patients undergoing surgery for symptomatic endometriomas (infertility and/or pelvic pain) larger than 3 cm', '60 patients was performed between July 2017 and February 2018']","[""cystectomy versus 'one-step' laser vaporization"", 'CO2 technology', 'vaporization with CO2 laser', 'CO2 laser vaporization', 'CO2 fiber laser vaporization (without GnRH agonist therapy', 'drainage of the cyst content, biopsy and vaporization of the internal wall with a CO2 fiber laser', 'standardized laparoscopic stripping technique', 'laparoscopic stripping: cystectomy) or Group 2 (CO2 laser vaporization']","['ovarian reserve', 'comparison of intra-group AFC changes before and after surgery (ΔAFC', 'serum AMH levels', 'modification of serum AMH before and after surgery (ΔAMH', 'antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) levels', 'AFC of the operated ovary']","[{'cui': 'C1536148', 'cui_str': 'Chocolate cyst of ovary (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0341858', 'cui_str': 'Adenomyosis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0557677', 'cui_str': 'Internal wall (physical object)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}]",60.0,0.0973729,"Does CO2 laser vaporization offer better results in treating endometrioma in terms of ovarian reserve preservation compared to traditional cystectomy?
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ottolina', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Posadzka', 'Affiliation': 'Endocrinological Gynecology Department, Jagiellonian University, Collegium Medicum, Cracow, Poland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Castellano', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tandoi', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pagliardini', 'Affiliation': 'Division of Genetics and Cell Biology, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nocun', 'Affiliation': 'Centre of Ultrasound Diagnostic MWU DobreUSG, Cracow, Poland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jach', 'Affiliation': 'Endocrinological Gynecology Department, Jagiellonian University, Collegium Medicum, Cracow, Poland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey305']
1423,30299241,Efficacy of tocilizumab monotherapy after response to combined tocilizumab and methotrexate in patients with rheumatoid arthritis: the randomised JUST-ACT study.,"OBJECTIVES


The aim of the JUST-ACT study was to assess whether the add-on effect of tocilizumab (TCZ) to background methotrexate (MTX) observed in MTX-inadequate responders with active rheumatoid arthritis (RA), would be sustained when MTX is withdrawn.
METHODS


A double-blind, parallel-group, phase 3 study in biologic-naïve RA patients with a disease activity score 28 (DAS28)>3.2 despite MTX which were treated with TCZ+MTX for an initial 16-week period. Patients who at week 16 achieved low disease activity (LDA) (DAS28≤3.2) were randomised to continue with TCZ+MTX or switch to TCZ + placebo (PBO) for an additional 12 weeks. The primary endpoint was the change in DAS28-ESR from the randomisation at week 16 to week 28. Non-inferiority was confirmed if the upper limit of the two-sided 95%CI for the treatment difference between TCZ+MTX and TCZ monotherapy groups was lower than the selected non-inferiority margin of 0.6.
RESULTS


261 patients completed the first 16 weeks of TCZ+MTX treatment and 165 were randomised (83 to TCZ+MTX and 82 to TCZ+PBO). For the primary endpoint, the adjusted treatment difference (95% CI) in mean change of DAS28-ESR was -0.06 (-0.40 to 0.27), and therefore the non-inferiority of switching to TCZ monotherapy versus continuing with TCZ+MTX was demonstrated. In both treatment groups, the percentage of patients in clinical remission from 16 to 28 weeks was similar as were the improvements in disease activity, functional disability and quality of life.
CONCLUSIONS


In MTX non-responder patients achieving LDA with TCZ+MTX, switching to TCZ monotherapy is non-inferior to continuing the combination.",2019,"In both treatment groups, the percentage of patients in clinical remission from 16 to 28 weeks was similar as were the improvements in disease activity, functional disability and quality of life.
","['patients with rheumatoid arthritis', 'MTX-inadequate responders with active rheumatoid arthritis (RA', '261 patients completed the first 16 weeks of', 'biologic-naïve RA patients with a disease activity score 28 (DAS28)>3.2 despite MTX which were treated with', 'Patients who at week 16 achieved low disease activity (LDA) (DAS28≤3.2']","['tocilizumab and methotrexate', 'methotrexate (MTX', 'tocilizumab monotherapy', 'TCZ+MTX or switch to TCZ + placebo (PBO', 'TCZ+MTX', 'tocilizumab (TCZ', 'MTX', 'TCZ monotherapy']","['change in DAS28-ESR', 'mean change of DAS28-ESR', 'disease activity, functional disability and quality of life', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",261.0,0.244298,"In both treatment groups, the percentage of patients in clinical remission from 16 to 28 weeks was similar as were the improvements in disease activity, functional disability and quality of life.
","[{'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Pablos', 'Affiliation': 'Department of Rheumatology, Instituto de Investigación Hospital 12 de Octubre, Universidad Complutense de Madrid, Spain. jlpablos@h12o.es.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Navarro', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Department of Rheumatology, Hospital Universitario A Coruña, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Román-Ivorra', 'Affiliation': 'Department of Rheumatology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Rheumatology, Hospital de Cruces, Bilbao, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Martín Mola', 'Affiliation': 'Department of Rheumatology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cantalejo', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Fuenlabrada, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Ercole', 'Affiliation': 'Roche Farma, Madrid, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Rivero', 'Affiliation': 'Roche Farma, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental rheumatology,[]
1424,30281320,Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction.,"BACKGROUND


The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.
METHODS


In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
RESULTS


A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18,  p =0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94,  p =0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45,  p =0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24,  p =0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93,  p =0.82).
CONCLUSION


Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.",2019,"The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
","['3001 patients with non-ST-elevation myocardial infarction, were enrolled', 'patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use', 'patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with', 'non-ST-segment elevation myocardial infarction', 'patients with non-ST-elevation myocardial infarction treated with']","['percutaneous coronary intervention', 'heparin', 'Bivalirudin', 'bivalirudin', 'heparin monotherapy', 'ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention']","['rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days', 'major bleeding', 'definite stent thrombosis', 'myocardial infarction', 'All-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",3001.0,0.0946849,"The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Danielewicz', 'Affiliation': 'PCI-Unit, Karlstad Hospital, Sweden.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Hamid', 'Affiliation': 'Department of Cardiology, Mälarsjukhuset, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Pettersson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Cardiology, Helsingborg Lasarett, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Grimfjärd', 'Affiliation': 'Department of Internal Medicine, Västmanlands Sjukhus, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Capio S:t Görans Hospital AB, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ulvenstam', 'Affiliation': 'Department of Cardiology, Östersund Hospital, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Völz', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Petursson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Sarno', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Scherstén', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eriksson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618805663']
1425,30278777,Effect of Exercise on Behavioral Symptoms and Pain in Patients With Dementia Living in Nursing Homes.,"OBJECTIVES


Examine the effects of a 6-month exercise intervention on neuropsychiatric symptoms, pain, and medication consumption in older people with dementia (PWD) living in nursing homes (NH).
METHODS


Ninety-one older PWD living in NH performed a 6-month structured exercise intervention (n = 44) or a social activity intervention (n = 47). Neuropsychiatric symptoms were measured by the neuropsychiatric inventory (NPI), pain was assessed using the Algoplus scale, and dementia-related drug prescriptions were obtained for all participants.
RESULTS


Between-group analysis found a nonsignificant difference that could be of clinical relevance: a 4-point difference in the NPI and 1.3-point difference in the reduction of the number of medications favoring exercisers. No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group.
CONCLUSION


Exercise effects did not differ from social intervention effects on neuropsychiatric symptoms, pain, and medication consumption in older PWD living in NH.",2019,"No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group.
","['older people with dementia (PWD) living in nursing homes (NH', 'Ninety-one older PWD living in NH performed a 6-month', 'older PWD living in NH', 'Patients With Dementia Living in Nursing Homes']","['structured exercise intervention', 'Exercise', 'exercise intervention', 'social activity intervention']","['neuropsychiatric symptoms, pain, and medication consumption', 'Behavioral Symptoms and Pain', 'pain', 'neuropsychiatric inventory (NPI), pain', 'medication consumption', 'Neuropsychiatric symptoms']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",91.0,0.0687231,"No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group.
","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Paul-Emile', 'Initials': 'PE', 'LastName': 'Haÿ', 'Affiliation': 'Institut Bien Vieillir Korian, Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Armaingaud', 'Affiliation': 'Institut Bien Vieillir Korian, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cestac', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Rouch', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cesari', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317518803773']
1426,30239456,Effects of Two Different Tapering Protocols on Fitness and Physical Match Performance in Elite Junior Soccer Players.,"Krespi, M, Sporiš, G, and Trajković, N. Effects of two different tapering protocols on fitness and physical match performance in elite junior soccer players. J Strength Cond Res 34(6): 1731-1740, 2020-The purpose of this study was to determine the effects of 2 different tapering protocols on fitness and physical match performance in elite junior soccer players. One-hundred fifty-eight elite junior soccer players (mean age: 17.1 ± 0.79 years; mean height: 177.9 ± 6.64 cm; mean body mass: 71.3 ± 7.96 kg; and mean body mass index: 22.5 ± 1.66 kg·m) were randomly assigned to 2 groups: an exponential (n = 79) and a linear tapering (n = 79) group. Training sessions were conducted 3 times per week for 8 weeks. After 4 weeks of training and 4 weeks of tapering, participants were assessed in terms of body composition, physical fitness, and distance covered within a match. Both groups showed similar changes for body composition. The exponential group showed better improvement than the linear group in the 5- and 30-m sprints, countermovement jump, and V[Combining Dot Above]O2max (p < 0.05). The exponential tapering group had larger changes (p < 0.05) than the linear group in medium running (8-13 km·h) (6%; effect size = 0.26 compared with 5.5%; effect size = 0.22) and sprinting (>18 km·h) (26%; effect size = 0.72 compared to 21.7%; effect size = 0.60). The results show that exponential tapering produced better effects on speed, power, and endurance abilities than the linear protocol. Our results confirmed the reports of others that suggest that volume is the optimal variable to manipulate while maintaining both the intensity and the frequency of sessions.",2020,"The exponential group showed better improvement than the linear group in the 5- and 30-m sprints, countermovement jump, and V[Combining","['One-hundred fifty-eight elite junior soccer players (mean age: 17.1 ± 0.79 years; mean height: 177.9 ± 6.64 cm; mean body mass: 71.3 ± 7.96 kg; and mean body mass index: 22.5 ± 1.66 kg·m', 'elite junior soccer players', 'Elite Junior Soccer Players']",['J Strength Cond Res XX(X'],"['fitness and physical match performance', '5- and 30-m sprints, countermovement jump, and V[Combining', 'body composition', 'Fitness and Physical Match Performance', 'speed, power, and endurance abilities']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C4517510', 'cui_str': '1.66 (qualifier value)'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0178998,"The exponential group showed better improvement than the linear group in the 5- and 30-m sprints, countermovement jump, and V[Combining","[{'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Krespi', 'Affiliation': 'Faculty of Kinesiology, University of Split, Split, Croatia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Sporiš', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002861']
1427,31652404,"Impact of 24-h high and low fermentable oligo-, di-, monosaccharide, and polyol diets on markers of exercise-induced gastrointestinal syndrome in response to exertional heat stress.","The study aimed to determine the effects of 24-h high (HFOD) and low (LFOD) fermentable oligo-, di-, monosaccharide, and polyol (FODMAP) diets before exertional heat stress on gastrointestinal integrity, function, and symptoms. Eighteen endurance runners consumed a HFOD and a LFOD (double-blind crossover design) before completing 2 h of running at 60% maximal oxygen uptake in 35 °C ambient temperature. Blood samples were collected before and after exercise to determine plasma cortisol and intestinal fatty acid binding protein (I-FABP) concentrations, and bacterial endotoxin and cytokine profiles. Breath hydrogen (H 2 ) and gastrointestinal symptoms (GIS) were determined pre-exercise, every 15 min during, and in recovery. No differences were observed for plasma cortisol concentration between diets. Plasma I-FABP concentration was lower on HFOD compared with LFOD ( p  = 0.033). A trend for lower lipopolysaccharide binding protein ( p  = 0.088), but not plasma soluble CD14 ( p  = 0.478) and cytokine profile ( p  > 0.05), responses on HFOD was observed. A greater area under the curve breath H 2  concentration ( p  = 0.031) was observed throughout HFOD (mean and 95% confidence interval: HFOD 2525 (1452-3597) ppm·4 h -1 ) compared with LFOD (1505 (1031-1978) ppm·4 h -1 ). HFOD resulted in greater severity of GIS compared with LFOD (pre-exercise,  p  = 0.017; during,  p  = 0.035; and total,  p  = 0.014). A 24-h HFOD before exertional heat stress ameliorates disturbances to epithelial integrity but exacerbates carbohydrate malabsorption and GIS severity in comparison with a LFOD.  Novelty  Twenty-four-hour high FODMAP diet ameliorated disturbances to gastrointestinal integrity. Twenty-four-hour high FODMAP diet results in greater carbohydrate malabsorption compared with low FODMAP diet. Incidence of GIS during exertional heat stress were pronounced on both low and high FODMAP diets, but greater GIS severity was observed with high FODMAP diet.",2020,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).",['Eighteen endurance runners'],"['24-hour high and low fermentable oligo- di- mono- saccharide polyol diets', '24-h high (HFOD) and low (LFOD) fermentable oligo- di- mono- saccharide and polyol diets', 'FODMAP diet', 'HFOD']","['plasma cortisol and I-FABP concentrations, and bacterial endotoxin and cytokine profiles', 'GIS severity', 'plasma sCD14', 'AUC breath H2 concentration', 'Breath hydrogen (H2) and gastrointestinal symptoms (GIS', 'disturbances to gastrointestinal integrity', 'carbohydrate malabsorption', 'HFOD and LFOD', 'cytokine profile', 'severity of GIS', 'gastrointestinal integrity, function, and symptoms', 'HFOD', 'Plasma I-FABP concentration', 'plasma cortisol concentration']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption Syndrome'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",18.0,0.0319401,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).","[{'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Gaskell', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology - The Alfred Hospital, Monash University, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0187']
1428,30231801,Short-term changes in added sugar consumption by adolescents reflected in the carbon isotope ratio of fingerstick blood.,"BACKGROUND


Consumption of added sugars (AS) and sugar-sweetened beverages (SSB) may adversely affect adolescents' weight and cardiovascular disease risk. Reliance on self-reported dietary assessment methods is a common research limitation, which could be overcome by dietary intake biomarkers.
AIM


The investigation was a proof-of-concept study to evaluate the proposed carbon isotope ratio (δ 13 C) biomarker of AS intake in adolescents, using a controlled feeding design.
METHODS


Participants ( n  = 33, age 15.3 years, 53% female) underwent two seven-day controlled feeding periods in a randomly assigned order. Diets were matched in composition except for AS content (5% or 25% of total energy). Fasting fingerstick blood samples were collected daily during each diet period.
RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p  ≤ 0.001). Reliability was demonstrated between day 7 and 8 δ 13 C values on the 5% (ICC = 0.996 , p  ≤ 0.001) and 25% (ICC = 0.997,  p  ≤ 0.001) AS diets.
CONCLUSIONS


Larger scale investigations are warranted to determine if this technique could be applied to population-level research in order to help assess the effectiveness of interventions aimed at reducing the consumption of AS or SSB intake.",2018,"RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p ≤ 0.001).","['Participants ( n = 33, age 15.3 years']",['added sugars (AS) and sugar-sweetened beverages (SSB'],"['Fasting fingerstick blood samples', 'Reliability', 'carbon isotope ratio of fingerstick blood']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0007017', 'cui_str': 'Carbon Isotopes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005768'}]",,0.0344239,"RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p ≤ 0.001).","[{'ForeName': 'Sarah V', 'Initials': 'SV', 'LastName': 'Liu', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Moore', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'A Hope', 'Initials': 'AH', 'LastName': 'Jahren', 'Affiliation': 'Centre for Earth Evolution and Dynamics, University of Oslo, Norway.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Savla', 'Affiliation': 'Department of Human Development and Center for Gerontology, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Valisa E', 'Initials': 'VE', 'LastName': 'Hedrick', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Elaina L', 'Initials': 'EL', 'LastName': 'Marinik', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Davy', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}]",Nutrition and health,['10.1177/0260106018799522']
1429,31654345,Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.,"BACKGROUND


One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel ""staplerless"" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB.
METHODS


The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB.
RESULTS


Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m 2 ), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12.
CONCLUSIONS


At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
TRIAL REGISTRATION


ISRCTN56106651 (OSPAN-RCT).",2019,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
",[],"['staplerless OAGB-BSGP, or group B, stapled OAGB', 'Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP', 'anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP', 'OAGB-BSGP and standard OAGB']","['weight loss', 'abdominal bleeding']",[],"[{'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",,0.255256,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
","[{'ForeName': 'Oral', 'Initials': 'O', 'LastName': 'Ospanov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan. bariatric.kz@gmail.com.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Buchwald', 'Affiliation': 'Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA.'}, {'ForeName': 'Galymzhan', 'Initials': 'G', 'LastName': 'Yeleuov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Bekmurzinova', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}]",Obesity surgery,['10.1007/s11695-019-04236-1']
1430,30260251,A dose-response relationship study of hypertonic saline on brain relaxation during supratentorial brain tumour craniotomy.,"Background:  A prospective, randomized, double-blind study was designed to assess differences in brain relaxation between 2 doses of 3% HS during elective supratentorial brain tumour surgery. Methods:  60 patients undergoing supratentorial craniotomy for tumour resection were enrolled to receive either 3 mL/kg (group L) or 5 mL/kg (group H) of 3% HS administered at skin incision. Brain relaxation was assessed after dura opening on a scale ranging 1-4 (1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain). Hemodynamic variables and laboratory values (blood gases, osmolarity, haematocrit, and lactate) were collected before HS infusion and 30, 120 and 360 min after it. Presence of midline shift, postoperative complications, PCU and hospital stay, and mortality after 30 days were also recorded. Results:  There was no difference in brain relaxation, with 2.0 (1.0-3.0) and 2.0 (1.0-2.3) ( P  = 0.535) for patients in groups L and H, respectively. If adjusted for the presence of midline shift, 50% of patients had adequate brain relaxation scores (grades 1 and 2) in group L and 61% in group H (OR 0.64, CI = 0.16-2.49,  P  = 0.515). No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed. Conclusion:  3 mL/kg of 3% HS result in similar brain relaxation scores as 5 mL/kg in patients undergoing craniotomy for supratentorial brain tumour. This study reveals that both high and low doses of 3% HS may be less effective on intraoperative brain relaxation in patients with midline shift.",2018,"No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed.
","['patients with midline shift', 'supratentorial brain tumour craniotomy', '60 patients undergoing supratentorial craniotomy for tumour resection']","['3\u2009mL/kg (group L) or 5\u2009mL/kg (group H) of 3% HS administered at skin incision', 'hypertonic saline', 'HS']","['Hemodynamic variables and laboratory values (blood gases, osmolarity, haematocrit, and lactate', 'intraoperative brain relaxation', 'brain relaxation scores', 'Brain relaxation', 'perioperative outcome, mortality and length of PCU and hospital stay', 'midline shift, postoperative complications, PCU and hospital stay, and mortality', 'brain relaxation', 'adequate brain relaxation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1522407', 'cui_str': 'Supratentorial brain structure (body structure)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}, {'cui': 'C0441842', 'cui_str': 'Group H (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",60.0,0.337276,"No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed.
","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Hernández-Palazón', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fuentes-García', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Doménech-Asensi', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Burguillos-López', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'García-Ferreira', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Falcón-Araña', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Piqueras-Pérez', 'Affiliation': 'Department of Neurosurgery, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}]",British journal of neurosurgery,['10.1080/02688697.2018.1508640']
1431,30274772,Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial.,"BACKGROUND


Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial.
METHODS


NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy.
FINDINGS


Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; p interaction =0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51-8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69-4·70; p interaction =0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24-0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity.
INTERPRETATION


Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted.
FUNDING


Bayer and Janssen.",2018,"Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; p interaction =0·18).","['Patients with PFO assigned to receive', 'patent foramen ovale and embolic stroke of undetermined source', 'patients with cryptogenic stroke and PFO', 'patients with PFO enrolled in the NAVIGATE ESUS trial', 'Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive', 'patients with ESUS']","['Rivaroxaban or aspirin', 'aspirin', 'transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE', 'rivaroxaban versus aspirin', 'rivaroxaban', 'rivaroxaban and aspirin', 'anticoagulant or antiplatelet therapy']","['risk of recurrent stroke', 'PFO', 'recurrent stroke', 'major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis', 'risks of major bleeding', 'risk of recurrent ischaemic stroke', 'efficacy and safety', 'recurrent ischaemic stroke rate', 'time to recurrent ischaemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0016522', 'cui_str': 'Patent Oval Foramen'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",7213.0,0.455181,"Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; p interaction =0·18).","[{'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: kasner@pennmedicine.upenn.edu.'}, {'ForeName': 'Balakumar', 'Initials': 'B', 'LastName': 'Swaminathan', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lavados', 'Affiliation': 'Clinica Alemana de Santiago, Universidad del Desarrollo, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, Queen Elizabeth University Hospital, University of Glasgow, Glasgow, Scotland, UK.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Chefarzt, Neurologische Klinik, Alfried-Krupp Krankenhaus Rüttenscheid, Essen, Germany.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Ameriso', 'Affiliation': 'Institute for Neurological Research, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, Argentina.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Department of Neurology, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Messé', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': 'Robarts Research Institute and Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Krassen', 'Initials': 'K', 'LastName': 'Nedeltechev', 'Affiliation': 'Department of Neurology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Santo', 'Affiliation': 'Department of Neurology, Hospitais da Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Olavarria', 'Affiliation': 'Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences (Neurology), Department of Neurology and Rehabilitation Medicine, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bangdiwala', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Vice President and Head, Thrombosis Group, Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer-Pharma AG, Wuppertal, Germany.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Division of Neurology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30319-3']
1432,30198199,Ultrasound-guided femoral nerve blocks are not superior to ultrasound-guided fascia iliaca blocks for fractured neck of femur.,"OBJECTIVE


To determine if an ultrasound-guided femoral nerve block (FNB) is superior to an ultrasound-guided fascia iliaca compartment block (FICB) in providing pain relief to patients with a neck of femur or proximal femoral fracture.
METHODS


A double-blind randomised controlled trial was conducted. All participants received two blocks, one active and one placebo. An active FICB was administered to 52 participants and 48 participants received an active FNB.
RESULTS


Analysis was completed on data collected from 100 participants. Most patients were elderly and the majority were female. Both FICB and FNB achieved clinically significant mean reductions in pain scores (2.62 for FICB and 2.3 for FNB). There was no significant difference in reduction in pain scores between the two cohorts, P = 0.408.
CONCLUSIONS


Ultrasound-guided FNB is not superior to ultrasound-guided FICB, with both facilitating an equivalent analgesia effect in patients with a neck of femur or proximal femur fracture.",2019,Both FICB and FNB achieved clinically significant mean reductions in pain scores (2.62 for FICB and 2.3 for FNB).,"['patients with a neck of femur or proximal femur fracture', 'Most patients were elderly and the majority were female', '52 participants and 48 participants received an', 'patients with a neck of femur or proximal femoral fracture']","['placebo', 'ultrasound-guided femoral nerve block (FNB', 'active FNB', 'Ultrasound-guided femoral nerve blocks', 'ultrasound-guided fascia iliaca compartment block (FICB']",['pain scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",100.0,0.392418,Both FICB and FNB achieved clinically significant mean reductions in pain scores (2.62 for FICB and 2.3 for FNB).,"[{'ForeName': 'Alannah L', 'Initials': 'AL', 'LastName': 'Cooper', 'Affiliation': 'Emergency Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Nagree', 'Affiliation': 'Emergency Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Goudie', 'Affiliation': 'Emergency Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Watson', 'Affiliation': 'Emergency Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Arendts', 'Affiliation': 'Emergency Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13172']
1433,30198318,"Effects of Heart Rate Reduction With Either Pyridostigmine or Ivabradine in Patients With Heart Failure: A Randomized, Double-Blind Study.","BACKGROUND


Heart rate (HR) reduction with ivabradine has been proved to reduce hospitalization and death from heart failure (HF). We sought to investigate whether pyridostigmine would effectively reduce HR in patients with chronic HF as compared with ivabradine.
METHODS


Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment, were included in a randomized, double-blind study comparing pyridostigmine versus ivabradine. The initial dose of ivabradine was 5 mg twice daily to reach a target HR between 50 and 60 bpm and could be titrated to a maximum of 7.5 mg twice daily. Pyridostigmine was used in a fixed dose of 30 mg 3 times daily.
RESULTS


The baseline HR for ivabradine and pyridostigmine groups was 89.1 (13.5) and 80.1 (7.2) bpm, respectively ( P  = .083). After 6 months of treatment, HR was significantly reduced to 64.8 (8.3) bpm in the ivabradine group ( P  = .0014) and 63.6 (5.9) bpm in the pyridostigmine group ( P  = .0001). The N-terminal pro-B-type natriuretic peptide was reduced in the ivabradine group (median: 1308.4 [interquartile range: 731-1896] vs 755.8 [134.5-1014] pg/mL;  P  = .027) and in the pyridostigmine group (132.8 [89.9-829] vs 100.7 [38-360] pg/mL;  P  = .002). Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups. Exercise capacity was improved in both groups, with increments in volume of oxygen utilization ( V ˙ O 2 ; ivabradine: 13.1 vs 15.6,  P  = .048; pyridostigmine: 13.3 vs 16.7,  P  = .032). Heart rate recovery in the first minute postexercise was improved with pyridostigmine (11.8 [3.9] vs 18 [6.5];  P  = .046), but not with ivabradine (13.3 [6.9] vs 14.1 [8.2];  P  = .70). No differences in either group were observed in the myocardial scintigraphy with 123-iodine-metaiodobenzylguanidine.
CONCLUSION


Both drugs significantly reduced HR, with improvements in exercise capacity and in neurohormonal and inflammatory profiles.",2019,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","['Patients With Heart Failure', 'Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment', 'patients with chronic HF as compared with ivabradine']","['ivabradine', 'Pyridostigmine or Ivabradine', 'pyridostigmine', 'pyridostigmine versus ivabradine', 'Pyridostigmine']","['Heart Rate Reduction', 'volume of oxygen utilization', 'HR', 'Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor', 'Heart rate recovery', 'exercise capacity and in neurohormonal and inflammatory profiles', 'Exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",21.0,0.262683,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","[{'ForeName': 'Aline Sterque', 'Initials': 'AS', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'José Antônio', 'Initials': 'JA', 'LastName': 'Caldas', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bernardo Campanário', 'Initials': 'BC', 'LastName': 'Precht', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pilar Barreto', 'Initials': 'PB', 'LastName': 'Porto', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Letícia Ubaldo', 'Initials': 'LU', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Neves', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Analucia Rampazzo', 'Initials': 'AR', 'LastName': 'Xavier', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Kanaan', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Tinoco', 'Initials': 'CT', 'LastName': 'Mesquita', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antônio Cláudio Lucas', 'Initials': 'ACL', 'LastName': 'da Nóbrega', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248418799364']
1434,31898677,A phase 2 randomized controlled trial of oral resistant starch supplements in the prevention of acute radiation proctitis in patients treated for cervical cancer.,"Background


Radiation induced proctitis is frequently encountered during the radiation therapy of cervical and prostate cancers that causes pain and occasionally with bleeding and may affect the continuity of radiation therapy.
Aims and Objectives


The purpose of the study is to look at the benefit of administration of an oral prebiotic amylase resistant starch in reducing the incidence of acute radiation proctitis, a distressing symptom in patients receiving radiation therapy for cancer of the cervix.
Material and Methods


The study was conducted between 2011 and 2014 in 104 patients receiving radical chemo-radiotherapy for carcinoma cervix. Patients were randomized in to two arms, one receiving 30 gm of resistant starch and the other digestible starch on a daily basis throughout the course of the external radiotherapy. All patients received standard 4-field box radiation portals, 50 Gy in 25 fractions with 4 cycles of weekly concurrent Cisplatin. At completion of external beam radiotherapy, all patients underwent LDR/HDR brachytherapy. The study was double blinded and allocation was concealed from the investigators. The investigator recorded the radiotherapy related toxicity of the patients according to CTC V 3.0. The incidence and severity of grade 2-4 diarrhoea and proctitis were documented on a weekly basis and compared across the two groups and analyzed. Stool short chain fatty acid concentrations were measured at baseline at 2 nd  and 4 th  week and after 6 weeks of completion of radiotherapy in both study placebo arms and reported. The pattern of microbiota in the stool were also estimated in all patients at 4 time points. Two patients who progressed during therapy were not included in the analyses and two patients discontinued the intervention. A per protocol analyses was done.
Results


At analysis there were 50 patients in each arm. The severity of clinical proctitis was found to be similar in both groups of patients with 12.2 % of patients experiencing toxicity of grade 2 and above in digestible starch group versus 14.6% in the resistant starch group. Functional proctitis was similarly graded and it was found that 16.3 % patients in digestible starch group experienced toxicity against 10.2 % patients in the resistant starch group. This difference was seen at 4 th  week and continued in the subsequent weeks till the end of radiation. Both groups had similar reported toxicity at 6 weeks post intervention and similar incidence of grade 2 and above diarrhea. The resistant starch group was found to have 8% incidence as compared to 2% in the other group at the 5 th  and 6 th  week. The short chain fatty acid concentrations were not significantly different in the groups at any point.
Conclusion


The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy. The reasons may be attributed to concurrent use of chemotherapy and decrease in intestinal probiotics. The use of digestible starch in the control arm may have contributed to lower incidence of the toxicity endpoints as well.",2019,The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy.,"['patients treated for cervical cancer', '2011 and 2014 in 104 patients receiving', 'patients receiving radiation therapy for cancer of the cervix', 'for carcinoma cervix']","['external beam radiotherapy', 'oral prebiotic amylase resistant starch', 'pelvic radiotherapy', 'standard 4-field box radiation portals, 50 Gy in 25 fractions with 4 cycles of weekly concurrent Cisplatin', 'digestible starch', 'LDR/HDR brachytherapy', 'radical chemo-radiotherapy', 'oral resistant starch supplements', 'resistant starch and the other digestible starch']","['severity of clinical proctitis', 'Stool short chain fatty acid concentrations', 'acute radiation proctitis', 'Functional proctitis', 'incidence and severity of grade 2-4 diarrhoea and proctitis', 'short chain fatty acid concentrations', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4048328', 'cui_str': 'Cervix Cancer'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0033246', 'cui_str': 'Proctitis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0400828', 'cui_str': 'Acute radiation proctitis (disorder)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",104.0,0.0406993,The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy.,"[{'ForeName': 'Balu Krishna', 'Initials': 'BK', 'LastName': 'Sasidharan', 'Affiliation': 'Department of Radiation Oncology, Wellcome Research Unit, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Balamurugan', 'Initials': 'B', 'LastName': 'Ramadass', 'Affiliation': 'Department of Biochemistry, Wellcome Research Unit, Christian Medical College Hospital, Vellore, Tamil Nadu; Department of Biochemisry, All India Institute of Medical Sciences, Bhubhaneswar, Orrisa, India.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Radiation Oncology, Wellcome Research Unit, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Samuel', 'Affiliation': 'Department of Biostatistics, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Mahasampath', 'Initials': 'M', 'LastName': 'Gowri', 'Affiliation': 'Department of Biostatistics, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Pugazhendhi', 'Affiliation': 'Department of Biochemistry, Wellcome Research Unit, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Balakrishnan S', 'Initials': 'BS', 'LastName': 'Ramakrishna', 'Affiliation': 'Department of Gastroenterology, Christian Medical College Hospital, Vellore; Department of Medical Gastroentrology, Institute of Gastroenterology, Hepatobiliary Science and Transplantation SRM Institutes for Medical Science, Chennai, Tamil Nadu, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_152_19']
1435,30158069,"Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event.
METHODS


ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059.
FINDINGS


Between July 5, 2007, and Nov 15, 2016, 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36-3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group).
INTERPRETATION


The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies.
FUNDING


Bayer.",2018,The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311,"['patients at moderate risk', 'Between July 5, 2007, and Nov 15, 2016, 12\u2008546 patients', 'seven countries', 'Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors', 'patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes', 'patients with a moderate estimated risk of a first cardiovascular event', 'patients at moderate risk of cardiovascular disease (ARRIVE']","['placebo tablets', 'computer-generated randomisation code to receive enteric-coated aspirin tablets', 'aspirin', 'placebo']","['overall incidence of treatment-related adverse events', 'haemorrhagic events and incidence of other adverse events', 'Gastrointestinal bleeding events', 'composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack', 'risk of initial vascular events', 'overall incidence rate of serious adverse events', 'efficacy and safety', 'overall incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",12546.0,0.699512,The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311,"[{'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Brigham and Women's Hospital, Department of Medicine, Division of Aging, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA. Electronic address: jmgaziano@partners.org.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brotons', 'Affiliation': 'Sardenya Primary Health Care Center, EAP Sardenya-Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppolecchia', 'Affiliation': 'Bayer HealthCare LLC, Whippany, NJ, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cricelli', 'Affiliation': 'Società Italiana di Medicina Generale, Florence, Italy.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Department of Cardiology, Angiology, Nephrology and Intensive Care Medicine, Vivantes Neukoelln Medical Center, Berlin, Germany.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Gorelick', 'Affiliation': 'Department of Translational Science & Molecular Medicine, Michigan State University College of Human Medicine, Grand Rapids, MI, USA; Vascular Neurology Program, Mercy Health Hauenstein Neurosciences, Grand Rapids, Michigan Grand Rapids, MI, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Pearson', 'Affiliation': 'Department of Epidemiology and Medicine, University of Florida Health Science Center, Gainsville, FL, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Internal Medicine, Complutense University, Head of the Hypertension Unit, 12 de Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Tognoni', 'Affiliation': 'IRCCS - Istituto di Ricerche Farmacologiche ""Mario Negri"", Department of Cardiovascular Research, IRCSS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)31924-X']
1436,30156134,Patients' self-report on post-retained restoration is more valuable than expected! Explorative analysis of an 11-year follow-up.,"Objective:  Assessment of long-term clinical data regarding post-endodontic restorations is essential for the evaluation of different post-and-core concepts. The aim of the present study was to assess the diagnostic accuracy of patient self-reporting on post-endodontic restorations after 11 years of clinical service. Materials and methods:  Twenty-nine patients (61 ± 15 years old) with endodontic glass-fibre and titanium post-endodontic restorations were examined within the 11-year follow-up of a randomized controlled trial. Restorations were assessed by self-reports during a telephone interview (one item), the completion of a four-item questionnaire and clinical and radiographic examination. A gold standard for restoration  in situ  or 'failure' was defined by clinical and radiographic examination. Diagnostic accuracy of patients' self-reports was evaluated by calculating the sensitivity, specificity, and positive (PPV) and negative predictive values (NPV). Results:  After a mean observation time of 137 months (min/max: 125/154 months), 25 (86.2%) restorations were  in situ  and 4 (13.8%) failures were detected. Self-report during a telephone interview and the four-item questionnaire correctly identified all  in situ  restorations (specificity = both 100%, NPV = 92.6%/96.2%). Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%). Conclusions:  When the clinical examination is not feasible, patients' self-report shows valuable diagnostic potential in the identification of the post-endodontic failure.",2019,"Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%).
","['Twenty-nine patients (61\u2009±\u200915 years old) with endodontic glass-fibre and titanium post-endodontic restorations', 'patient self-reporting on post-endodontic restorations after 11 years of clinical service']",[],"['sensitivity, specificity, and positive (PPV) and negative predictive values (NPV']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",[],"[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0340304,"Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%).
","[{'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'von Stein-Lausnitz', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Matthias J', 'Initials': 'MJ', 'LastName': 'Roggendorf', 'Affiliation': 'Department of Operative Dentistry and Endodontics, Medical Center for Dentistry, University Medical Center Giessen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Sterzenbach', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naumann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2018.1497804']
1437,31858447,Imbalance Between Salivary Cortisol and DHEA Responses Is Associated with Social Cost and Self-perception to Social Evaluative Threat in Japanese Healthy Young Adults.,"BACKGROUND


Social evaluative threat activates the HPA-axis system, namely cortisol and dehydroepiandrosterone (DHEA) responses. Additionally, cognitive and behavioral models in social anxiety, which is aroused anxiety symptoms in social situations, indicate that negative cognitions have a role in the maintenance of symptoms. Thus, the present study examined the relationship between HPA-axis activity and cognitive features in social situations.
METHOD


We conducted the Trier Social Stress Test (TSST) with 44 male participants and assessed HPA-axis responses, fear of negative evaluation, the estimated social cost, and self-perceptions of their speech performance, which are core negative cognitions in social situations.
RESULTS


Results revealed that the cortisol-DHEA ratio significantly correlated with self-perceptions of participants' speech performance (r = .30, p = .044) and the discrepancy between self-ratings and others' ratings of the speech (r = .44, p = .003). After controlling for depressive symptoms, significant correlations remained (r = .39, p = .01 and r = .50, p = .001, respectively). In addition, the estimated social cost, assessed before the speech task, significantly correlated with both the AUCg cortisol (r = .38, p = .011) and cortisol-DHEA ratios (r = .40, p = .007).
CONCLUSION


These results suggest that estimating social costs in social situations, as well as distorted self-perceptions of that stressor, is related to dysfunctional endocrine regulation.",2020,"RESULTS


Results revealed that the cortisol-DHEA ratio significantly correlated with self-perceptions of participants' speech performance (r = .30, p = .044) and the discrepancy between self-ratings and others' ratings of the speech (r = .44, p = .003).","['Japanese Healthy Young Adults', '44 male participants and assessed']",['Trier Social Stress Test (TSST'],"['AUCg cortisol', 'HPA-axis responses, fear of negative evaluation, the estimated social cost, and self-perceptions of their speech performance', 'estimated social cost', 'cortisol-DHEA ratios', 'cortisol-DHEA ratio']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0128899,"RESULTS


Results revealed that the cortisol-DHEA ratio significantly correlated with self-perceptions of participants' speech performance (r = .30, p = .044) and the discrepancy between self-ratings and others' ratings of the speech (r = .44, p = .003).","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Shirotsuki', 'Affiliation': 'Faculty of Human Sciences, Musashino University, 3-3-3, Ariake, Koto-ku, Tokyo, 135-8181, Japan. kenshiro@musashino-u.ac.jp.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Izawa', 'Affiliation': 'Occupational Stress Research Group, National Institute of Occupational Safety and Health, Kaganawa, Japan.'}, {'ForeName': 'Nagisa', 'Initials': 'N', 'LastName': 'Sugaya', 'Affiliation': 'Yokohama City University, Kanagawa, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'National Institute of Advanced Industrial Science and Technology, Ibaraki, Japan.'}, {'ForeName': 'Namiko', 'Initials': 'N', 'LastName': 'Ogawa', 'Affiliation': 'Advanced Research Center for Human Sciences, Waseda University, Saitama, Japan.'}, {'ForeName': 'Kosuke Chris', 'Initials': 'KC', 'LastName': 'Yamada', 'Affiliation': 'Graduate School of Media and Governance, Keio University, Kanagawa, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nagano', 'Affiliation': 'Bunkyo Gakuin University, Saitama, Japan.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09835-x']
1438,29969341,Psychosocial stress promotes food intake and enhances the neuroenergetic level in men.,"Psychosocial stress may lead to increased food consumption and overweight. In turn, obesity is related to reduced brain energy content. We hypothesized that psychosocial stress influencing food intake may alter the neuroenergetic status in the human brain. We tested 14 healthy normal weight men in a randomized crossover design. A modified version of the Trier Social Stress Test (TSST) was carried out to induce psychosocial stress vs. control in a neuroimaging setting. Cerebral energy content, i.e. high energy phosphates adenosine triphosphate (ATP) and phosphocreatine (PCr), was measured by  31 phosphorus magnetic resonance spectroscopy. Food intake was quantified by an  ad libitum  buffet test. Stress hormonal response and alterations in glucose metabolism were monitored by blood sampling. Before data collection, we mainly expected a stress-induced reduction in cerebral high energy phosphates, followed by higher food intake. Psychosocial stress increased serum cortisol concentrations ( p  = .003) and fat intake of all participants by 25% ( p  = .043), as well as food intake of ""stress-eaters"" by 41.1% ( p  = .003) compared with controls. Blood glucose and insulin concentrations were not affected ( p  > .174 for both). Cerebral ATP and PCr levels generally increased upon stress-induction ( p  > = .022 and  p  = .037, respectively). Our data confirm that psychosocial stress may enhance food intake. Contrary to our expectations, stress induces a distinct increase in the neuroenergetic status. This insight suggests that the underlying central nervous mechanisms of stress-induced overeating may involve the regulation of the brain energy homeostasis.",2018,"Cerebral ATP and PCr levels generally increased upon stress-induction (p > = .022 and p = .037, respectively).","['men', '14 healthy normal weight men']",['Trier Social Stress Test (TSST'],"['fat intake', 'neuroenergetic level', 'Cerebral energy content, i.e. high energy phosphates adenosine triphosphate (ATP) and phosphocreatine (PCr', 'Stress hormonal response and alterations in glucose metabolism', 'Blood glucose and insulin concentrations', 'Cerebral ATP and PCr levels', 'food intake of ""stress-eaters', 'serum cortisol concentrations', 'Food intake', 'neuroenergetic status']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",14.0,0.0228682,"Cerebral ATP and PCr levels generally increased upon stress-induction (p > = .022 and p = .037, respectively).","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Kistenmacher', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Goetsch', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Ullmann', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ewelina K', 'Initials': 'EK', 'LastName': 'Wardzinski', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Uwe H', 'Initials': 'UH', 'LastName': 'Melchert', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Jauch-Chara', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2018.1485645']
1439,31365701,Effect of educational intervention based on the PRECEDE-PROCEED model on preventive behaviors of cutaneous leishmaniasis among housewives.,"Leishmaniasis is an endemic disease in Iran. Since education to prevent the disease is important, this study aimed to determine the effect of educational intervention based on the PRECEDE-PROCEED model on preventive behaviors of cutaneous leishmaniosis among housewives. In this quasi-experimental study, 240 housewives under the coverage of health centers, who lived in the endemic area of Mianshahr, Fasa city, Fars Province, Iran in 2016, were selected (120 people for the experimental group and 120 for the control group). The educational intervention for the experimental group was based on the PRECEDE model, which consists of seven 50-60-minute sessions of lectures, group discussions, role playing, practical displays, and video and PowerPoint displays. These sessions addressed the familiarity with cutaneous leishmaniasis and its different types and carriers, methods of preventing and fighting against it, personal protection, sanitation of the environment and drinking water, spraying of sites, use of mosquito nets, etc. Data were collected before educational intervention and three months after educational intervention. The mean age of the experimental group was 39.24±9.12 years and that of the control group was 38.84±9.28 years. Three months after the intervention, the experimental group showed a significant increase in knowledge, attitudes, reinforcing factors, enabling factors, and performance compared to the control group. The education based on enabling factors, reinforcing factors, and predisposing factors had a significant effect on the preventive behaviors of cutaneous leishmaniasis among housewives.",2019,"Three months after the intervention, the experimental group showed a significant increase in knowledge, attitudes, reinforcing factors, enabling factors, and performance compared to the control group.","['240 housewives under the coverage of health centers, who lived in the endemic area of Mianshahr, Fasa city, Fars Province, Iran in 2016, were selected (120 people for the experimental group and 120 for the control group', 'cutaneous leishmaniasis among housewives']",['educational intervention'],"['knowledge, attitudes, reinforcing factors, enabling factors, and performance']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023283', 'cui_str': 'Leishmaniasis, Cutaneous'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035011', 'cui_str': 'Reinforcing Factors'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}]",,0.0187875,"Three months after the intervention, the experimental group showed a significant increase in knowledge, attitudes, reinforcing factors, enabling factors, and performance compared to the control group.","[{'ForeName': 'Ali Khani', 'Initials': 'AK', 'LastName': 'Jeihooni', 'Affiliation': 'Fasa University of Medical Sciences, Fars, Iran.'}, {'ForeName': 'Pooyan Afzali', 'Initials': 'PA', 'LastName': 'Harsini', 'Affiliation': 'Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyyed Mansour', 'Initials': 'SM', 'LastName': 'Kashfi', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tayebe', 'Initials': 'T', 'LastName': 'Rakhshani', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Cadernos de saude publica,['10.1590/0102-311X00158818']
1440,30130424,Correlation Between Paramedic Disaster Triage Accuracy in Screen-Based Simulations and Immersive Simulations.,"Background:  Disaster triage is an infrequent, high-stakes skill set used by emergency medical services (EMS) personnel. Screen-based simulation (SBS) provides easy access to asynchronous disaster triage education. However, it is unclear if the performance during a SBS correlates with immersive simulation performance.  Methods:  This was a nested cohort study within a randomized controlled trial (RCT). The RCT compared triage accuracy of paramedics and emergency medical technicians (EMTs) who completed an immersive simulation of a school shooting, interacted with an SBS for 13 weeks, and then completed the immersive simulation again. The participants were divided into two groups: those exposed vs. those not exposed to  60 Seconds to Survival ©  (60S) , a disaster triage SBS. The aim of the study was to measure the correlation between SBS triage accuracy and immersive simulation triage accuracy. Improvements in triage accuracy were compared among participants in the nested study before and after interacting with  60S , and with improvements in triage accuracy in a previous study in which immersive simulations were used as an educational intervention.  Results:  Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays and were included in the evaluation of outcomes of interest. The mean number of plays was 8.5 (SD =7.4). Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004). There was no correlation between the amount of improvement in overall SBS triage accuracy, instances of overtriage (P = 0.101), instances of undertriage (P = 0.523), and improvement in the second immersive simulation. A comparison of the pooled data from a previous immersive simulation study with the nested cohort data showed similar improvement in triage accuracy (P = 0.079).  Conclusions:  SBS education was associated with a significant increase in triage accuracy in an immersive simulation, although triage accuracy demonstrated in the SBS did not correlate with the performance in the immersive simulation. This improvement in accuracy was similar to the improvement seen when immersive simulation was used as the educational intervention in a previous study.",2019,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).",['Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays'],['Screen-based simulation (SBS'],"['accuracy', 'triage accuracy', 'mean number of plays', 'overall SBS triage accuracy, instances of overtriage']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.0365779,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).","[{'ForeName': 'Mark X', 'Initials': 'MX', 'LastName': 'Cicero', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Whitfill', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Maria Carmen G', 'Initials': 'MCG', 'LastName': 'Diaz', 'Affiliation': ''}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Arteaga', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Scherzer', 'Affiliation': ''}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Madhok', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': ''}, {'ForeName': 'Geno', 'Initials': 'G', 'LastName': 'Paesano', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Redlener', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Munjal', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1475530']
1441,30027807,Examining the Impact of Group Size on the Treatment Intensity of a Tier 2 Mathematics Intervention Within a Systematic Framework of Replication.,"Group size and treatment intensity are understudied topics in mathematics intervention research. This study examined whether the treatment intensity and overall intervention effects of an empirically validated Tier 2 mathematics intervention varied between intervention groups with 2:1 and 5:1 student-teacher ratios. Student practice opportunities and the quality of explicit instruction served as treatment intensity metrics. A total of 465 kindergarten students with mathematics difficulties from 136 intervention groups participated. Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures. Observation data indicated that student practice differed by group size. Students in the 5:1 groups received more opportunities to practice with their peers, while students in the 2:1 groups participated in more frequent and higher quality individualized practice opportunities. Implications in terms of delivering Tier 2 interventions in small-group formats and engaging at-risk learners in meaningful practice opportunities are discussed.",2019,Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures.,['465 kindergarten students with mathematics difficulties from 136 intervention groups participated'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],[],465.0,0.0185637,Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures.,"[{'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Doabler', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Clarke', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kosty', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Evangeline', 'Initials': 'E', 'LastName': 'Kurtz-Nelson', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Hank', 'Initials': 'H', 'LastName': 'Fien', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Smolkowski', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}]",Journal of learning disabilities,['10.1177/0022219418789376']
1442,31647468,Antismoking Advertisements and Price Promotions and Their Association With the Urge to Smoke and Purchases in a Virtual Convenience Store: Randomized Experiment.,"BACKGROUND


Point of sale (POS) advertising is associated with smoking initiation, current smoking, and relapse among former smokers. Price promotion bans and antismoking advertisements (ads) are 2 possible interventions for combating POS advertising.
OBJECTIVE


The purpose of this analysis was to determine the influence of antismoking ads and promotions on urges to smoke and tobacco purchases.
METHODS


This analysis examined exposure to graphic (graphic images depicting physical consequences of tobacco use) and supportive (pictures of and supportive messages from former smokers) antismoking ads and promotions in a virtual convenience store as predictors of urge to smoke and buying tobacco products among 1200 current cigarette smokers and 800 recent quitters recruited via a Web-based panel (analytical n=1970). We constructed linear regression models for urge to smoke and logistic regression models for the odds of purchasing tobacco products, stratified by smoking status.
RESULTS


The only significant finding was a significant negative relationship between exposure to supportive antismoking ads and urge to smoke among current smokers (beta coefficient=-5.04, 95% CI -9.85 to -0.22; P=.04). There was no significant relationship between graphic antismoking ads and urge to smoke among current smokers (coefficient=-3.77, 95% CI -8.56 to 1.02; P=.12). Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20). There were no significant differences in urge to smoke by exposure to promotions for current smokers (coefficient=-1.06, 95% CI -4.53 to 2.41; P=.55) or recent quitters (coefficient=1.76, 95% CI -2.07 to 5.59; P=.37). There were also no differences in tobacco purchases by exposure to graphic (current smokers: coefficient=0.93, 95% CI 0.67 to 1.29; P=.66 and recent quitters: coefficient=0.73, 95% CI 0.44 to 1.19; P=.20) or supportive (current smokers: coefficient=1.05, 95% CI 0.75 to 1.46; P=.78 and recent quitters: coefficient=0.73, 95% CI 0.45 to 1.18; P=.20) antismoking ads or price promotions (current smokers: coefficient=1.09, 95% CI 0.86 to 1.38; P=.49 and recent quitters: coefficient=0.90, 95% CI 0.62 to 1.31; P=.60).
CONCLUSIONS


The results of this analysis support future research on the ability of supportive antismoking ads to reduce urges to smoke among current cigarette smokers. Research on urges to smoke has important tobacco control implications, given the relationship between urge to smoke and smoking cigarettes, time to next smoke, and amount smoked.",2019,"Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20).","['1200 current cigarette smokers and 800 recent quitters recruited via a Web-based panel (analytical n=1970', 'P=.78 and recent quitters']",[],"['tobacco purchases', 'graphic antismoking ads and urge to smoke', 'antismoking ads or price promotions', 'urge to smoke']","[{'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",1200.0,0.0474676,"Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20).","[{'ForeName': 'Lauren McCarl', 'Initials': 'LM', 'LastName': 'Dutra', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Berkeley, CA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bradfield', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Ireland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Feld', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Annice', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}]",Journal of medical Internet research,['10.2196/14143']
1443,30152712,"Assessment of antibacterial activity of 2.5% NaOCl, chitosan nano-particles against  Enterococcus faecalis  contaminating root canals with and without diode laser irradiation: an  in vitro  study.","Objective:  This study was done to evaluate the antibacterial effect of chitosan nano-particles (CNPs) root canal irrigant as a new alternative to Sodium hypochlorite (NaOCl) for disinfection of root canals inoculated with  Enterococcus faecalis , with and without laser activation. Methodology:  Sixty single rooted human premolars were decoronated, prepared and had their apical foramina sealed.  E. faecalis  were incubated in the root canals for 15 days. The teeth were then randomly divided into two experimental groups ( n  = 30) according to the disinfection protocol used. In Group I: disinfection was performed using the irrigant solutions only (Saline, 2.5% NaOCl, CNPs). Whereas in Group II, disinfection was done using the same irrigants followed by Diode laser at (980-nm) at 2 W output for 5 × 5 s. Intra-canal bacterial samples were taken before and after canal disinfection to determine the CFU count. Results:  In group I, 2.5% NaOCl was as effective as CNP in eradication and significantly more effective than Saline ( p  = 0.008) in eradication of  E. faecalis . In Group II, either 2.5% NaOCl or CNP in combination with diode laser irradiation showed a similarly high effect in bacterial eradication. Conclusions:  Within the parameters used in this study, a combination therapy consisting of irrigation followed by diode laser irradiation should be utilized as an effective treatment modality for eliminating E. faecalis from root canal systems.",2019,"In group I, 2.5% NaOCl was as effective as CNP in eradication and significantly more effective than Saline (p = 0.008) in eradication of E. faecalis.","['Sixty single rooted human premolars were decoronated, prepared and had their apical foramina sealed']","['antibacterial activity of 2.5% NaOCl, chitosan nano-particles against Enterococcus faecalis contaminating root canals with and without diode laser irradiation', 'irrigant solutions only (Saline, 2.5% NaOCl, CNPs', 'NaOCl or CNP', 'chitosan nano-particles (CNPs) root canal irrigant', 'diode laser irradiation']",['bacterial eradication'],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0085494', 'cui_str': 'Enterococcus'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0035846', 'cui_str': 'Root Canal Medicaments'}]",[],,0.0190408,"In group I, 2.5% NaOCl was as effective as CNP in eradication and significantly more effective than Saline (p = 0.008) in eradication of E. faecalis.","[{'ForeName': 'Nehal Nabil', 'Initials': 'NN', 'LastName': 'Roshdy', 'Affiliation': 'Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Engy M', 'Initials': 'EM', 'LastName': 'Kataia', 'Affiliation': 'Restorative and Dental Materials Department, National Research Centre, Cairo, Egypt.'}, {'ForeName': 'Neveen A', 'Initials': 'NA', 'LastName': 'Helmy', 'Affiliation': 'Researcher of Clinical and Chemical Pathology, National Research Centre, Cairo, Egypt.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2018.1498125']
1444,31433669,"Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study).","OBJECTIVES


To address the need for long-term lasmiditan data, the GLADIATOR study evaluated the safety (primary) and efficacy (secondary) of lasmiditan for the intermittent, acute treatment of migraine attacks for up to 1 year.
METHODS


In this prospective, randomized, open-label, Phase 3 study, patients who had completed either of two single-attack studies were offered the opportunity to be randomized 1:1 to lasmiditan 100 mg or 200 mg. Patients were asked to use lasmiditan as the first treatment for each new migraine attack of at least moderate severity. Assessments occurred at baseline and at prespecified time increments up to 48 hours after each dose of study drug using an electronic diary, and safety was assessed throughout the study. Migraine Disability Assessment (MIDAS) was assessed at each visit.
RESULTS


As of the cut-off date for this interim analysis (6 March 2018), 1978 patients had received ≥ 1 lasmiditan dose and treated 19,058 migraine attacks. Overall, treatment-emergent adverse events (TEAEs) were similar to those in the single-attack studies and included dizziness (18.6%), somnolence (8.5%), and paresthesia (6.8%). The frequency of TEAEs generally decreased with subsequent attacks. No treatment-related serious adverse events and no cardiovascular TEAEs potentially due to vasoconstriction were observed. For both lasmiditan doses, efficacy measures were generally consistent over study quarters and treated attacks. Overall, across all treated attacks at 2 hours post-dose, pain freedom was observed in 26.9% of the attacks treated with lasmiditan 100 mg and 32.4% of the attacks treated with lasmiditan 200 mg. MIDAS total scores decreased over time.
CONCLUSIONS


The interim results of this long-term study showed intermittent lasmiditan (100 mg and 200 mg) to be generally well tolerated and efficacious for the acute treatment of migraine over a 1-year period.  Trial registration number:  NCT02565186; https://clinicaltrials.gov/ct2/show/NCT02565186.",2019,No treatment-related serious adverse events and no cardiovascular TEAEs potentially due to vasoconstriction were observed.,"['patients who had completed either of two single-attack studies', '1978 patients had received\u2009≥\u20091 lasmiditan dose and treated 19,058 migraine attacks']",['lasmiditan 100\u2009mg or 200\u2009mg'],"['Migraine Disability Assessment (MIDAS', 'MIDAS total scores', 'paresthesia', 'dizziness', 'pain freedom', 'somnolence', 'tolerated and efficacious', 'efficacy measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456589', 'cui_str': '1978 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1978.0,0.0338541,No treatment-related serious adverse events and no cardiovascular TEAEs potentially due to vasoconstriction were observed.,"[{'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group, Department of Neurology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Klise', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Case', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rashna', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Lilly UK, Windlesham, Surrey, UK.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Vasudeva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Raskin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419864132']
1445,31640705,"Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial.","BACKGROUND


Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) improve cardiovascular and renal outcomes in patients with type 2 diabetes through distinct mechanisms. However, evidence on clinical outcomes in patients treated with both GLP-1 RA and SGLT2i is lacking. We aim to provide insight into the effects of open-label SGLT2i use in parallel with or shortly after once-weekly GLP-1 RA exenatide (EQW) on cardiorenal outcomes.
METHODS


In the EXSCEL cardiovascular outcomes trial EQW arm, SGLT2i drop-in occurred in 8.7% of participants. These EQW+SGLT2i users were propensity-matched to: (1) placebo-arm participants not taking SGLT2i (n = 572 per group); and to (2) EQW-arm participants not taking SGLT2i (n = 575), based on their last measured characteristics before SGLT2i initiation, and equivalent study visit in comparator groups. Time-to-first major adverse cardiovascular event (MACE) and all-cause mortality (ACM) were compared using Cox regression analyses. eGFR slopes were quantified using mixed model repeated measurement analyses.
RESULTS


In adjusted analyses, the risk for MACE with combination EQW+SGLT2i use was numerically lower compared with both placebo (adjusted hazard ratio 0.68, 95% CI 0.39-1.17) and EQW alone (0.85, 0.48-1.49). Risk of ACM was nominally significantly reduced compared with placebo (0.38, 0.16-0.90) and compared with EQW (0.41, 0.17-0.95). Combination EQW+SGLT2i use also nominally significantly improved estimated eGFR slope compared with placebo (+ 1.94, 95% CI 0.94-2.94 mL/min/1.73 m 2 /year) and EQW alone (+ 2.38, 1.40-3.35 mL/min/1.73 m 2 /year).
CONCLUSIONS


This post hoc analysis supports the hypothesis that combinatorial EQW and SGLT2i therapy may provide benefit on cardiovascular outcomes and mortality. Trial registration Clinicaltrials.gov, Identifying number: NCT01144338, Date of registration: June 15, 2010.",2019,"Risk of ACM was nominally significantly reduced compared with placebo (0.38, 0.16-0.90) and compared with EQW (0.41, 0.17-0.95).","['type 2 diabetes', 'patients with type 2 diabetes through distinct mechanisms']","['EQW', 'EQW+SGLT2i', 'exenatide and open-label SGLT2 inhibitor treatment', 'GLP-1 RA exenatide (EQW', 'open-label SGLT2i', 'placebo', 'placebo-arm participants not taking SGLT2i', 'Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA', 'EQW-arm participants not taking SGLT2i']","['estimated eGFR slope', 'cardiovascular outcomes and mortality', 'Time-to-first major adverse cardiovascular event (MACE) and all-cause mortality (ACM', 'Risk of ACM', 'cardiovascular and renal outcomes', 'eGFR slopes', 'mortality and cardiovascular and renal outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",575.0,0.46749,"Risk of ACM was nominally significantly reduced compared with placebo (0.38, 0.16-0.90) and compared with EQW (0.41, 0.17-0.95).","[{'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Clegg', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA. lindsay.clegg1@astrazeneca.com.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Penland', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Bachina', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Thuresson', 'Affiliation': 'Statisticon AB, Uppsala, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gustavson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Ruggles', 'Affiliation': 'BioPharmaceuticals, AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0942-x']
1446,31646953,"""Fear the Flu, Not the Flu Shot"": A Test of the Extended Parallel Process Model.","This study investigates the effects of manipulated threat and efficacy on college students' attitudes, intentions, and behavior toward receiving the influenza vaccine (flu shot). Meta-analysis results indicate that during the nearly 70-year history of fear-appeal research, as few as six studies have orthogonally manipulated threat and efficacy, randomly assigned participants to conditions, and included a behavioral dependent variable. While there may be several practical reasons for this, it is problematic theoretically. The primary goal of this study is to add to this small but important body of literature. We tested the Extended Parallel Process Model, utilizing a 2 (high threat/low threat) × 2 (high efficacy/low efficacy) between-subjects design with random assignment to conditions. Dependent variables were attitudes and intentions regarding the flu shot (measured immediately after reading the message at Time 1) and flu shot behavior (measured 30 days later at Time 2). Results indicate that participants in the high threat condition reported greater perceived severity, susceptibility, and fear than participants in the low threat condition; and that that participants in the high-efficacy condition reported greater self-efficacy and response-efficacy than individuals in the low efficacy condition. Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior. Instead, there was a main effect for efficacy (but not threat) on attitudes and intentions, and no effect for either efficacy or threat on behavior. The theoretical and practical implications of these findings are discussed.",2019,"Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior.",['college students'],['influenza vaccine (flu shot'],"['severity, susceptibility, and fear', 'self-efficacy and response-efficacy', 'attitudes and intentions regarding the flu shot', 'flu shot behavior']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0147438,"Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Roberto', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Mongeau', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Emi C', 'Initials': 'EC', 'LastName': 'Hashi', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1673520']
1447,31898663,A comparison of six fractions per week chemoradiation versus five fractions per week of conventional chemoradiation in carcinoma cervix: A prospective controlled study.,"Aims


The standard of care for carcinoma cervix stage IB2-IVA is five fractions per week of radiotherapy (RT) with concurrent cisplatin. We compared the standard treatment with six fractions per week of RT with concurrent Cisplatin to see whether the later had improved survival outcomes with comparable toxicities.
Settings and Design


46 patients of carcinoma cervix with stage IB2-IVAwere randomized into two arms.
Materials and Methods


Study arm: 46 Gy/23 fractions/26 days, 6 fractions/week with injection CDDP 40 mg/m 2  and Control arm: 46 Gy/23 fractions/31 days, 5 fractions/week with injection Cisplatin 40mg/m 2 . Patients in both the arms received LDR brachytherapy to a dose of 29 Gy at point A.
Statistical Analysis Used


The primary end points were disease-free survival (DFS) and overall survival (OS). Compliance to treatment and treatment toxicities were the secondary end points. P value ≤0.05 were considered significant.
Results


The study was carried out during June, 2014-April, 2015. Statistical analysis was done in May, 2019. Of 46 patients, 39 patients completed the treatment. The study and control arms had 17 and 22 patients, respectively. Median follow-up period is 45 months (range: 1-54 months). 3-year DFS rates and OS was 69.5% vs. 72.7% (P = 0.73) and 63% vs. 68% (P = 0.45) in study and in control arm, respectively. There was no significant difference in acute and late radiation toxicities between two arms.
Conclusion


Chemoradiotherapy with six fractions per week seems feasible and equally efficacious in terms of survival outcomes and toxicity profile. Further prospective randomized controlled study is required to prove the merit of altered fractionation with concurrent cisplatin.",2019,"3-year DFS rates and OS was 69.5% vs. 72.7% (P = 0.73) and 63% vs. 68% (P = 0.45) in study and in control arm, respectively.","['46 patients, 39 patients completed the treatment', 'carcinoma cervix', '46 patients of carcinoma cervix with stage IB2-IVAwere randomized into two arms']","['cisplatin', 'LDR brachytherapy', 'six fractions per week chemoradiation versus five fractions per week of conventional chemoradiation', 'injection CDDP', 'radiotherapy (RT) with concurrent cisplatin']","['survival outcomes', 'disease-free survival (DFS) and overall survival (OS', 'acute and late radiation toxicities', '3-year DFS rates and OS', 'survival outcomes and toxicity profile', 'Compliance to treatment and treatment toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",46.0,0.067003,"3-year DFS rates and OS was 69.5% vs. 72.7% (P = 0.73) and 63% vs. 68% (P = 0.45) in study and in control arm, respectively.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh; Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Satyajit', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Lalit M', 'Initials': 'LM', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Avipsa', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Sovan', 'Initials': 'S', 'LastName': 'Sarangdhar', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kaser', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Dewangan', 'Affiliation': 'Department of Radiotherapy and Radiation Medicine, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_698_19']
1448,29992432,Effectiveness of Health Belief Model on Oral Cancer Prevention in Smoker Men.,"The purpose of the present study is investigating the effect of educational intervention based on health belief model (HBM) on oral cancer prevention in smoker men. This is a quasi-experimental study carried out on 200 smoker men with the age of 40 or older (100 subjects for the experimental group and 100 subjects for control group) resident in Fasa City, Fars Province, Iran, in 2017-2018. The educational intervention for the experimental group included seven educational sessions for 50 or 55 min-based HBM. A questionnaire consisted of items about demographic information, knowledge, HBM constructs (perceived susceptibility, severity, benefits, barriers, self-efficacy, and cues to action) was used to measure the oral cancer prevention before and 6 months after the intervention. The mean age of the men was 51.35±8.41 years in the experimental group and 52.28±8.09 years in the control group. Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group. Also, results indicated that, the educational program based on HBM model have positive effect on oral cancer prevention with the improvement of subject's knowledge, perceived susceptibility, severity, benefits, and self-efficacy.",2019,"Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group.","['Smoker Men', '200 smoker men with the age of 40 or older (100 subjects for the experimental group and 100 subjects for control group) resident in Fasa City, Fars Province, Iran, in 2017-2018', 'smoker men']","['educational intervention based on health belief model (HBM', 'Health Belief Model']","['average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors', 'knowledge, HBM constructs (perceived susceptibility, severity, benefits, barriers, self-efficacy, and cues to action', ""subject's knowledge, perceived susceptibility, severity, benefits, and self-efficacy"", 'Oral Cancer Prevention']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",200.0,0.0114368,"Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group.","[{'ForeName': 'Ali Khani', 'Initials': 'AK', 'LastName': 'Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran. Khani_1512@yahoo.com.'}, {'ForeName': 'Samira Fatehi', 'Initials': 'SF', 'LastName': 'Dindarloo', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran.'}, {'ForeName': 'Pouyan Afzali', 'Initials': 'PA', 'LastName': 'Harsini', 'Affiliation': 'Department of Public Health, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1396-7']
1449,31585010,"Methodological concerns on 'Assessment of ovarian reserve after cystectomy versus ""one-step"" laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial'.",,2019,,['ovarian endometrioma'],"['cystectomy versus ""one-step"" laser vaporization']",[],"[{'cui': 'C1536148', 'cui_str': 'Chocolate cyst of ovary (disorder)'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}]",[],,0.0470425,,"[{'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Leone Roberti Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez140']
1450,31585011,"Reply: Methodological concerns on `Assessment of ovarian reserve after cystectomy versus ""one-step"" laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial'.",,2019,,['ovarian endometrioma'],"['cystectomy versus ""one-step"" laser vaporization']",[],"[{'cui': 'C1536148', 'cui_str': 'Chocolate cyst of ovary (disorder)'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}]",[],,0.0452657,,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ottolina', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez141']
1451,30153096,Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features.,"PURPOSE


Cytoreductive therapy is beneficial in patients with essential thrombocythemia (ET) at high risk of thrombosis. However, its value in those lacking high-risk features remains unknown. This open-label, randomized trial compared hydroxycarbamide plus aspirin with aspirin alone in patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis.
PATIENTS AND METHODS


Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 10 9 /L), hypertension, or diabetes requiring therapy. In all, 382 patients were randomly assigned 1:1 to hydroxycarbamide plus aspirin or aspirin alone. The composite primary end point was time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes. Secondary end points were time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life.
RESULTS


After a median follow-up of 73 months and a total follow-up of 2,373 patient-years, there was no significant difference between the arms in the likelihood of patients reaching the primary end point (hazard ratio, 0.98; 95% CI, 0.42 to 2.25;  P  = 1.0). The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41). There were also no differences in overall survival; in the composite end point of transformation to myelofibrosis, acute myeloid leukemia, or myelodysplasia; in adverse events; or in patient-reported quality of life.
CONCLUSION


In patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of hydroxycarbamide to aspirin did not reduce vascular events, myelofibrotic transformation, or leukemic transformation. Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 10 9 /L should not receive cytoreductive therapy.",2018,"The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41).","['patients with essential thrombocythemia (ET) at high risk of thrombosis', '382 patients', 'Patients and Methods Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 10 9 /L), hypertension, or diabetes requiring therapy', 'patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis', 'Patients With Essential Thrombocythemia Age 40 to 59 Years', 'patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of', 'Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 10 9 /L should not receive cytoreductive therapy']","['hydroxycarbamide plus aspirin or aspirin alone', 'aspirin', 'Hydroxycarbamide Plus Aspirin Versus Aspirin', 'hydroxycarbamide to aspirin', 'hydroxycarbamide plus aspirin']","['incidence of significant vascular events', 'time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life', 'quality of life', 'time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes', 'overall survival', 'acute myeloid leukemia, or myelodysplasia; in adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040028', 'cui_str': 'Thrombocytosis, Primary'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0836924', 'cui_str': 'Thrombocythemia'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",382.0,0.131016,"The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41).","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Godfrey', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Campbell', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'MacLean', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Buck', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Temple', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Bridget S', 'Initials': 'BS', 'LastName': 'Wilkins', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Nangalia', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Grinfeld', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Mary Frances', 'Initials': 'MF', 'LastName': 'McMullin', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Kiladjian', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Green', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Claire N', 'Initials': 'CN', 'LastName': 'Harrison', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.8414']
1452,30132686,Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder.,"Objective:  A recent double-blind randomized placebo-controlled study demonstrated 3-month efficacy and safety of a novel pediatric-appropriate prolonged-release melatonin (PedPRM) for insomnia in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity. Long-term efficacy and safety of PedPRM treatment was studied.  Methods:  A prospective, open-label efficacy and safety follow-up of nightly 2, 5, or 10 mg PedPRM in subjects who completed the 13-week double-blind trial (51 PedPRM; 44 placebo). Measures included caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index).  Results:  Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received PedPRM (2/5 mg) according to the double-blind phase dose, for 39 weeks with optional dose adjustment (2, 5, or 10 mg/day) after the first 13 weeks. After 52 weeks of continuous treatment (PedPRM-randomized group) subjects slept (mean [SE]) 62.08 (21.5) minutes longer ( p  = 0.007); fell asleep 48.6 (10.2) minutes faster ( p  < 0.001); had 89.1 (25.5) minutes longer uninterrupted sleep episodes ( p  = 0.001); 0.41 (0.12) less nightly awakenings (>50% decrease;  p  = 0.001); and better sleep quality ( p  < 0.001) compared with baseline. The placebo-randomized group also improved with PedPRM. Altogether, by the end of 39-week follow-up, regardless of randomization assignment, 55/72 (76%) of completers achieved overall improvement of ≥1 hour in total sleep time (TST), sleep latency or both, over baseline, with no evidence of decreased efficacy. In parallel, CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns ( p  < 0.001 for both), PSQI global ( p  < 0.001), and WHO-5 ( p  = 0.001) improved in statistically significant and clinically relevant manner ( n  = 72) compared with baseline. PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients).  Conclusion:  PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.",2018,"PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients).
","['Children with Autism Spectrum Disorder', 'children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity', 'subjects who completed the 13-week double-blind trial (51 PedPRM; 44', 'Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received']","['Pediatric Prolonged-Release Melatonin', 'PedPRM', 'placebo', 'novel pediatric-appropriate prolonged-release melatonin (PedPRM']","[""CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns"", ""caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index"", 'WHO-5', 'nightly awakenings', 'uninterrupted sleep episodes', 'overall improvement of ≥1 hour in total sleep time (TST), sleep latency', 'PSQI global', 'efficacy', 'sleep quality', ""caregivers' quality of life""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0034380'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",95.0,0.55034,"PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients).
","[{'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Academy, Yulius Mental Health Organization, Barendrecht, The Netherlands.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Schroder', 'Affiliation': 'Strasbourg University Hospital Department of Child and Adolescent Psychiatry, Strasbourg, France.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Sleep Division, Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Kennedy Krieger Institute/Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Breddy', 'Affiliation': 'Pharmastat Consulting Ltd., Canterbury, United Kingdom.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Nir', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Shahmoon', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Zisapel', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gringras', 'Affiliation': ""Children's Sleep Medicine, Evelina London Children's Hospital, Guy's and St. Thomas', London, United Kingdom.""}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0020']
1453,30060707,Efficacy of EGF and Gelatin Sponge for Traumatic Tympanic Membrane Perforations: A Randomized Controlled Study.,"OBJECTIVE


To compare the outcomes of epidermal growth factor (EGF) and gelatin sponge patch treatments for traumatic tympanic membrane perforations.
STUDY DESIGN


Prospective, randomized, controlled.
SETTING


University-affiliated teaching hospital.
SUBJECTS AND METHODS


In total, 141 perforations encompassing >50% of the eardrum were randomly divided into 3 groups: EGF (n = 47), gelatin sponge patch (n = 47), and observation (n = 47). The edges of the perforations were not approximated. The closure rate, mean closure time, and infection rate were evaluated at 6 months and the related factors analyzed.
RESULTS


A total of 135 perforations were analyzed. At 6 months, the closure rates were 97.8%, 86.7%, and 82.2% in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P  = .054). The mean ± SD closure time was 11.12 ± 4.60, 13.67 ± 5.37, and 25.65 ± 13.32 days in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P  < .001). In addition, the presence of infection was not significantly associated with rate of closure in any group.
CONCLUSIONS


As compared with spontaneous healing, daily application of EGF and gelatin sponge patching reduced the closure time of traumatic tympanic membrane perforations. EGF treatment had a higher closure rate and shorter closure time but resulted in otorrhea. By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication. Thus, the appropriate treatment should be selected according to patient need.",2018,"By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication.","['Setting University-affiliated teaching hospital', 'Traumatic Tympanic Membrane Perforations', 'traumatic tympanic membrane perforations']","['EGF', 'epidermal growth factor (EGF) and gelatin sponge patch treatments', 'gelatin sponge patch', 'gelatin sponge patches', 'EGF and gelatin sponge patching', 'EGF and Gelatin Sponge']","['rate of closure', 'closure rate or cause otorrhea', 'mean ± SD closure time', 'closure time of traumatic tympanic membrane perforations', 'closure rate, mean closure time, and infection rate', 'closure rates', 'closure rate and shorter closure time']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0585355', 'cui_str': 'Traumatic tympanic membrane perforation (disorder)'}]","[{'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0155540', 'cui_str': 'Otorrhea (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0585355', 'cui_str': 'Traumatic tympanic membrane perforation (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",135.0,0.0456551,"By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication.","[{'ForeName': 'Zheng Cai', 'Initials': 'ZC', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Affiliated Yiwu Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department Clinical Class No. 11, Clinical Medicine, Xinxiang Medical University, Henan, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599818792019']
1454,30031572,"Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial.","We tested whether intervention with atorvastatin affects the prostate beneficially compared with placebo in men with prostate cancer in a randomized clinical trial. A total of 160 statin-naïve prostate cancer patients scheduled for radical prostatectomy were randomized to use 80mg atorvastatin or placebo daily from recruitment to surgery for a median of 27 d. Blinding was maintained throughout the trial. In total, 158 men completed the follow-up, with 96% compliance. Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo. In subgroup analyses, after a minimum of 28 d of atorvastatin use, Ki-67 was 14.1% lower compared with placebo (p = 0.056). Among high-grade cases (International Society of Urological Pathology Gleason grade 3 or higher), atorvastatin lowered PSA compared with placebo: median change -0.6 ng/ml; p = 0.024. Intraprostatic inflammation did not differ between the study arms (p = 0.8). Despite a negative overall result showing no effect of statins on Ki67 or PSA overall, in post hoc exploratory analyses, there appeared to be benefit after a minimum duration of 28 d. Further studies are needed to verify this. PATIENT SUMMARY: Cholesterol-lowering atorvastatin does not lower prostate cancer proliferation rate compared with placebo overall, but exploratory analyses suggest a benefit in longer exposure.",2018,"Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo.","['Prostate Cancer', '158 men completed the follow-up, with 96% compliance', '160 statin-naïve prostate cancer patients scheduled for radical prostatectomy', 'men with prostate cancer']","['atorvastatin or placebo', 'placebo', 'Placebo', 'atorvastatin', 'Atorvastatin Versus Placebo', 'Cholesterol-lowering atorvastatin']","['tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA', 'Intraprostatic inflammation']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",160.0,0.327601,"Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo.","[{'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland. Electronic address: teemu.murtola@uta.fi.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Syvälä', 'Affiliation': 'Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Tolonen', 'Affiliation': 'Fimlab Laboratories, Department of Pathology, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': 'Science Center, Pirkanmaa Hospital District, Tampere, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Koskimäki', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tomi', 'Initials': 'T', 'LastName': 'Pakarainen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kaipia', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Isotalo', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Fimlab Laboratories, Department of Pathology, Tampere, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}]",European urology,['10.1016/j.eururo.2018.06.037']
1455,30022377,"How Does Health Education Given to Lung Cancer Patients Before Thoracotomy Affect Pain, Anxiety, and Respiratory Functions?","In this study, it was aimed to determine how the postoperative pain level, state-trait anxiety level, and respiratory function were affected by the health education given through a patient education booklet to patients with lung cancer, in comparison with control group, before pulmonary resection through thoracotomy. The 60 patients (n = 60) having pulmonary resection indication because of lung cancer were recruited in the present study. The patients were separated as control (n = 30) and experimental groups (n = 30). The patient education was applied to patients in the experimental groups via the education booklet 24 h before the surgery. Patients in the control groups received only usual clinical nursing information. The pain was evaluated via visual analog scale (VAS). The State-Trait Anxiety Scale (STAS) was used for evaluating the anxiety level. The evaluated pulmonary functions were peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and forced expiratory flow 25-75 (FEF25-75). The pain level of the experimental group was statistically lower than control group (p < 0.05). The state anxiety level of experimental group received education was statistically lower than control group (p < 0.05). There was no any statistical difference in trait anxiety levels between control and experimental groups (p > 0.05). The FEV1 and FEF25-75 values in experimental group were statistically higher than control group. A planned health education applied via the thoracotomy patient education booklet has a positive effect on clinical recovery process by affecting postoperative pain, state anxiety, and FEV1 and FEF25-75 values.",2019,The pain level of the experimental group was statistically lower than control group (p < 0.05).,"['Lung Cancer Patients', '60 patients (n\u2009=\u200960) having pulmonary resection indication because of lung cancer']",['usual clinical nursing information'],"['trait anxiety levels', 'State-Trait Anxiety Scale (STAS', 'Pain, Anxiety, and Respiratory Functions', 'pain was evaluated via visual analog scale (VAS', 'peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory volume in 1\xa0s (FEV1), and forced expiratory flow 25-75 (FEF25-75', 'FEV1 and FEF25-75 values', 'state anxiety level', 'postoperative pain level, state-trait anxiety level, and respiratory function', 'pain level']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0193302,The pain level of the experimental group was statistically lower than control group (p < 0.05).,"[{'ForeName': 'Hatice Esra', 'Initials': 'HE', 'LastName': 'Cetkin', 'Affiliation': 'Department of Nursing, Institute of Health Science, Sanko University, İncilipınar Mah., Gazi Muhtar Pasa Bulv. No:36, 27090, Şehitkamil, Gaziantep, Turkey. es-ra85@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Tuna', 'Affiliation': 'Department of Nursing, Institute of Health Science, Sanko University, İncilipınar Mah., Gazi Muhtar Pasa Bulv. No:36, 27090, Şehitkamil, Gaziantep, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1401-1']
1456,31898656,Interdigitated versus sequential high-dose-rate intracavitary brachytherapy with external beam radiotherapy in locally advanced carcinoma cervix.,"Aims


To decrease overall treatment time (OTT) and to compare the clinical outcome of interdigitated high-dose-rate intracavitary brachytherapy (HDRICBT) versus sequential HDRICBT with external beam radiotherapy (EBRT) in the treatment of locally advanced carcinoma cervix.
Methods


Eighty-two patients with histologically confirmed carcinoma of the cervix, untreated International Federation of Gynecology and Obstetrics Stage IIB-IIIB, were included and randomized into two groups. The study group received EBRT 50 Gy/25 fractions with interdigitated HDRICBT 8 Gy/fraction weekly a total of three fractions. Patients in the control group received EBRT 50 Gy/25 fractions with sequential HDRICBT 8 Gy/fraction weekly a total of three fractions. At the end of the study, results of both groups compared in terms of OTT, acute and late toxicities, and response to therapy clinically.
Results


A total of 82 patients were enrolled 41 in each arm. Seventy-two patients completed treatment and were analyzed. Mean OTT in study group and control group was 40 and 60 days, respectively. The median follow-up duration was 10 months (3-18). Most of the acute and late toxicities were of Grade 1 and 2 type and comparable in both study and control groups. Treatment interruption due to treatment-related toxicity was slightly higher in the study group than the control group, but it was statistically insignificant. Os negotiability was not found to be a limiting factor for interdigitated HDRICBT.
Conclusion


Interdigitated HDRICBT has equivalent response and toxicities as sequential HDRICBT with the advantage of significant reduction in OTT.",2019,"Treatment interruption due to treatment-related toxicity was slightly higher in the study group than the control group, but it was statistically insignificant.","['locally advanced carcinoma cervix', 'Methods\n\n\nEighty-two patients with histologically confirmed carcinoma of the cervix, untreated International Federation of Gynecology and Obstetrics Stage IIB-IIIB', '82 patients were enrolled 41 in each arm']","['interdigitated high-dose-rate intracavitary brachytherapy (HDRICBT) versus sequential HDRICBT with external beam radiotherapy (EBRT', 'sequential high-dose-rate intracavitary brachytherapy with external beam radiotherapy', 'EBRT 50 Gy/25 fractions with interdigitated HDRICBT 8 Gy/fraction weekly a total of three fractions']","['overall treatment time (OTT', 'OTT, acute and late toxicities, and response to therapy clinically', 'acute and late toxicities', 'toxicity']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0021864', 'cui_str': 'Intracavity Radiotherapy'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",82.0,0.033438,"Treatment interruption due to treatment-related toxicity was slightly higher in the study group than the control group, but it was statistically insignificant.","[{'ForeName': 'Nawed', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': 'Department of Radiotherapy, J. N. Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Akram', 'Affiliation': 'Department of Radiotherapy, J. N. Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Shahid Ali', 'Initials': 'SA', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Radiotherapy, J. N. Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'M A Bilal', 'Initials': 'MAB', 'LastName': 'Hussain', 'Affiliation': 'Department of Radiotherapy, J. N. Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_301_17']
1457,31645229,Feasibility and efficacy of a hospital-based violence intervention program on reducing repeat violent injury in youth: a randomized control trial.,"OBJECTIVES


To determine feasibility and efficacy of an Emergency Department Violence Intervention Program (EDVIP) to reduce violence related injuries in youth.
METHODS


One hundred and thirty youth aged 14-24 presenting to an emergency with violence related injury were randomized in parallel to receive EDVIP for 1 year (n = 65) or a waitlist control (n = 65). The primary outcome was to determine feasibility. Secondary outcomes are incidence, number/severity of repeat violence related injury, justice and education systems interactions, substance misuse and mental health presentations, and ED length of stay (LOS).
RESULTS


This study established feasibility in recruitment, outcomes collection and safety. Fidelity and adherence measures required optimization during the study. Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health. LOS decreased by 59.5 min (p = 0.21).
CONCLUSIONS


This program is feasible for ED implementation and for completion of a future RCT to measure effectiveness.",2020,"Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health.","['youth', 'One hundred and thirty youth aged 14-24 presenting to an emergency with violence related injury', 'violence related injuries in youth']","['waitlist control', 'EDVIP', 'hospital-based violence intervention program', 'Emergency Department Violence Intervention Program (EDVIP']","['Feasibility and efficacy', 'LOS', 'incidence, number/severity of repeat violence related injury, justice and education systems interactions, substance misuse and mental health presentations, and ED length of stay (LOS', 'improved engagement in education']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",130.0,0.12209,"Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health.","[{'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Snider', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON.""}, {'ForeName': 'Depeng', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Sarvesh', 'Initials': 'S', 'LastName': 'Logsetty', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Chernomas', 'Affiliation': 'College of Nursing, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Mordoch', 'Affiliation': 'College of Nursing, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Cochrane', 'Affiliation': 'First Nations Health and Social Secretariat of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Mahmood', 'Affiliation': 'Spence Neighbourhood Association, Winnipeg, MB.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}]",CJEM,['10.1017/cem.2019.406']
1458,29951902,Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: a Quasi-Experimental Study.,"Educational programs are important tools for breast cancer prevention. The purpose of this study was to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer. A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method and non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n = 75) were compared to the control group (n = 75) at baseline, as well as at 6 weeks and 3 months post-intervention. Knowledge of breast cancer screening tools was measured using a modified version of the Breast Cancer Knowledge test. Breast self-examination, clinical breast examination, and mammography practices were also measured. Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention. Thus, the results of this study provide evidence that group health education programs are effective in improving breast cancer knowledge and practices in female teachers. Clinical Trial Registration number: NCT03398057 .",2019,"Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention.","[""Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area"", '150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education', 'Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school']","['health education', 'Health Education']",['knowledge and practice levels'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[{'cui': 'C0018701'}],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",150.0,0.0138091,"Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention.","[{'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Alameer', 'Affiliation': 'Jazan Health Directorate, Ministry of Health, P.O. Box 1121, Abu Arish 45911, Jazan, Saudi Arabia. Alameeranwar@hotmail.com.'}, {'ForeName': 'Mohamed Salih', 'Initials': 'MS', 'LastName': 'Mahfouz', 'Affiliation': 'Family and Community Medicine Department, Faculty of Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Alamir', 'Affiliation': 'Health Education and Promotion Department, Faculty of Public health and Tropical Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Health Education and Promotion Department, Faculty of Public health and Tropical Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Darraj', 'Affiliation': 'Jazan Health Directorate, Ministry of Health, P.O. Box 1121, Abu Arish 45911, Jazan, Saudi Arabia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1386-9']
1459,31266353,Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine.,"BACKGROUND


Sustained pain freedom is an important attribute of acute migraine therapies for patients and physicians. Here we report efficacy of the centrally penetrant, highly selective, 5-HT 1F  agonist lasmiditan on sustained pain freedom and other outcomes at 24 and 48 hours post-dose.
STUDY DESIGN AND METHODS


Data from the similarly designed, Phase 3, double-blind studies SAMURAI (NCT02439320) and SPARTAN (NCT02605174) were pooled to more precisely estimate efficacy effects in these post-hoc analyses. In both studies, inclusion criteria were 3-8 migraine attacks per month and Migraine Disability Assessment Score of ≥ 11 (at least moderate disability). Patients were randomized equally to lasmiditan 200 mg, 100 mg, 50 mg (50 mg only in SPARTAN), or to placebo. The study drug was to be taken within 4 hours of onset of pain for non-improving headache of at least moderate severity. Sustained pain freedom was defined as being pain free at 2 hours and at the given time point (24 or 48 hours) post-dose without use of additional study drug or migraine medications. Sustained responses were assessed similarly for most bothersome symptom-free, total migraine-free, and disability-free outcomes. For comparisons with previously published data on other acute medications, an additional endpoint of modified sustained pain freedom at 24 hours was defined as being pain free at 2 hours and no moderate-to-severe headache at 24 hours post-dose without use of additional study drug or migraine medications.
RESULTS


Significantly higher proportions of patients treated with lasmiditan versus placebo achieved headache pain freedom at 2 hours post-dose: 200 mg: 35.6%; 100 mg: 29.9%; 50 mg: 28.6%; placebo: 18.3% (all  p  < 0.001). Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all  p  < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all  p  < 0.05). Similar sustained benefits of lasmiditan versus placebo at 24 and 48 hours were noted for most bothersome symptom-free, total migraine-free and disability-free responses. Modified sustained pain freedom at 24 hours was also observed in significantly higher proportions of lasmiditan-treated patients versus placebo: 200 mg: 27.0%; 100 mg: 21.7%; 50 mg: 21.7%; placebo: 12.9% (all  p  < 0.01).
CONCLUSION


Sustained responses at 24 and 48 hours were noted in significantly more patients treated with lasmiditan versus placebo for several efficacy outcomes including pain freedom, most bothersome symptom-free, total migraine-free and disability-free responses.
CLINICALTRIALS.GOV IDENTIFIER NUMBERS


SAMURAI: NCT02439320; SPARTAN: NCT02605174.",2019,Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all  p  < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all  p  < 0.05).,['patients and physicians'],"['SAMURAI', 'placebo', 'lasmiditan 200 mg, 100\u2009mg, 50\u2009mg (50\u2009mg only in SPARTAN), or to placebo', 'centrally penetrant, highly selective, 5-HT 1F  agonist lasmiditan', 'lasmiditan versus placebo']","['bothersome symptom-free, total migraine-free, and disability-free outcomes', 'bothersome symptom-free, total migraine-free and disability-free responses', 'pain freedom, most bothersome symptom-free, total migraine-free and disability-free responses', 'headache pain freedom', 'Sustained pain freedom', 'Modified sustained pain freedom']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",,0.283391,Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all  p  < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all  p  < 0.05).,"[{'ForeName': 'Erin Gautier', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Covance Chiltern, Princeton, NJ, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Raskin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kalidas', 'Affiliation': 'Division of Headache Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419859313']
1460,29941233,"Intravenous fish oil containing lipid emulsion attenuates inflammatory cytokines and the development of bronchopulmonary dysplasia in very premature infants: A double-blind, randomized controlled trial.","BACKGROUND & AIMS


Preterm infants have lower levels of long-chain polyunsaturated fatty acids (LCPUFAs). Supplementing very premature infants with intravenous lipid emulsions that fish oil, which is rich in n-3 LC-PUFAs, may decrease bronchopulmonary dysplasia (BPD) by modulating inflammation and neonatal immune function.
METHODS


Sixty very low birth weight (VLBW) premature infants requiring ventilator support were randomized in a double-blind manner to 2 groups and received total parenteral nutrition with fish oil containing LE (intervention group, n = 30) or soybean oil containing LE (control group, n = 30) for 7 days. Blood samples and bronchoalveolar lavage fluid (BALF) were obtained for assay on day 1 and 7 days after LE. The primary outcome was to compare the levels of interleukin (IL)-1β and IL-6 in serum and BALF. Secondary outcomes were to compare mortality and co-morbidities.
RESULTS


The levels of IL-1β and IL-6 in serum and BALF were significantly lower in the intervention group at day 8 (p < 0.05). The incidence of BPD in the intervention group compared to the control group was 13.3% versus 36.7% (p = 0.04; odds ratio [OR], 0.36; 95% confidence interval [CI], 0.21-0.86). The duration of ventilator support and oxygen use was significantly less in the intervention group than in the control group (p < 0.05). The level of alanine aminotransferase was significantly lower in the intervention group on day 8 (p = 0.031).
CONCLUSIONS


In very premature infants, early administration of fish oil containing LE significantly decreased IL-1β and IL-6 levels in serum and BALF and was associated with shorter duration of ventilator support and less bronchopulmonary dysplasia (BPD).
TRIAL REGISTRATION NUMBER


ISRCTN 11427103.",2019,The levels of IL-1β and IL-6 in serum and BALF were significantly lower in the intervention group at day 8 (p < 0.05).,"['Sixty very low birth weight (VLBW) premature infants requiring ventilator support', 'Supplementing very premature infants with', 'very premature infants']","['total parenteral nutrition with fish oil containing LE (intervention group, n\xa0=\xa030) or soybean oil containing LE', 'Intravenous fish oil containing lipid emulsion', 'intravenous lipid emulsions', 'fish oil containing LE']","['IL-1β and IL-6 levels', 'level of alanine aminotransferase', 'mortality and', 'levels of IL-1β and IL-6 in serum and BALF', 'duration of ventilator support and oxygen use', 'Blood samples and bronchoalveolar lavage fluid (BALF', 'levels of interleukin (IL)-1β and IL-6 in serum and BALF', 'bronchopulmonary dysplasia', 'incidence of BPD', 'shorter duration of ventilator support and less bronchopulmonary dysplasia (BPD']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006279', 'cui_str': 'Bronchial Alveolar Lavage Fluid'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",60.0,0.245716,The levels of IL-1β and IL-6 in serum and BALF were significantly lower in the intervention group at day 8 (p < 0.05).,"[{'ForeName': 'Chien-Chou', 'Initials': 'CC', 'LastName': 'Hsiao', 'Affiliation': ""Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan; Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan; School of Medicine, Kaohsiung Medical University, Taiwan.""}, {'ForeName': 'Hung-Chih', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': ""Department of Pediatrics, Children's Hospital, China Medical University, Taiwan.""}, {'ForeName': 'Yu-Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Shih-Pan', 'Initials': 'SP', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Lon-Yen', 'Initials': 'LY', 'LastName': 'Tsao', 'Affiliation': ""Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan.""}, {'ForeName': 'Cheng-Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': ""Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan.""}, {'ForeName': 'Hsiao-Neng', 'Initials': 'HN', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan.""}, {'ForeName': 'Jia-Yuh', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Yi-Giien', 'Initials': 'YG', 'LastName': 'Tsai', 'Affiliation': ""Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan; Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan; School of Medicine, Kaohsiung Medical University, Taiwan. Electronic address: 107239@cch.org.tw.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.06.929']
1461,29933355,Caffeine's Effects on an Upper-Body Resistance Exercise Workout.,"Salatto, RW, Arevalo, JA, Brown, LE, Wiersma, LD, and Coburn, JW. Caffeine's effects on an upper-body resistance exercise workout. J Strength Cond Res 34(6): 1643-1648, 2020-The purpose of this study was to examine the effects of caffeine on an upper-body resistance exercise workout. Fifteen men (mean ± SD: age, 23.1 ± 1.9 years; body mass, 89.1 ± 13.9 kg; height, 175 ± 6.1 cm) volunteered to come to the laboratory 3 times. During visit 1, 1-repetition maximum (RM) values were determined for the barbell bench press, incline barbell bench press, and dumbbell bench press exercises. For visit 2, subjects consumed either 800-mg caffeine or a placebo. Subjects then completed 3 sets to failure of each exercise using 80% of their 1RM. Visit 3 was the same as visit 2; however, participants consumed the opposite treatment as visit 2. Various perceptual measures were recorded before, during, and after the workouts. The results indicated that participants completed significantly more repetitions per set for the barbell bench press (4.80 ± 2.66) and incline barbell bench press (4.91 ± 2.29) in the caffeine condition compared with the placebo condition (4.42 ± 2.56 and 4.36 ± 2.11, respectively). Higher arousal scores were found in the caffeine condition. For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79). These results suggest that caffeine has an ergogenic effect on strength workout performance due, at least in part, to positive effects on workout perception. Athletes and recreational lifters may want to consider the ingestion of caffeine before a resistance exercise workout.",2020,"For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79).","['Fifteen men (mean ± SD: age, 23.1 ± 1.9 years; body mass, 89.1 ± 13.9 kg; height, 175 ± 6.1 cm) volunteered to come to the laboratory 3 times']","['800-mg caffeine', 'placebo', 'Caffeine', 'J Strength Cond Res XX(X', 'caffeine']","['Upper-Body Resistance Exercise Workout', 'strength workout performance', 'Higher arousal scores', 'Salatto, RW, Arevalo, JA, Brown, LE, Wiersma, LD, and Coburn, JW', '1-repetition maximum (RM) values']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0979866,"For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79).","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Salatto', 'Affiliation': 'Department of Kinesiology, Center for Sport Performance, California State University, Fullerton, California.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Arevalo', 'Affiliation': ''}, {'ForeName': 'Lee E', 'Initials': 'LE', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Lenny D', 'Initials': 'LD', 'LastName': 'Wiersma', 'Affiliation': ''}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Coburn', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002697']
1462,29926431,"French Therapeutic Education Programme Aimed at Improving the Quality of Life of Laryngectomised Patients and their Close Relations: the Three Stages (Observational and Interventional Randomised) of the Study ""PETAL"".","The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission. The intervention of a speech therapist, often serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. This report presents the therapeutic education programme protocol ""PETAL"" for laryngectomised patients and their close relations to improve their quality of life. The trial will be conducted over three phases: (1) the ""pilot"" phase aims at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations and developed a pluridisciplinary therapeutic education program, (2) the prospective intervention ""replication"" phase aims at evaluating the programme's transferability in three centres and (3) the cluster-randomised multicentric comparative intervention phase, will assess the benefits of the developed programme. Phase I identified nine themes of workshops related to therapeutic education, training and coordination of care. The developed programme should reinforce town-hospital links to improve help, follow-up and support for patients and their close relations.",2019,"The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology.",['of Laryngectomised Patients and their Close Relations'],['Total laryngectomy'],['Quality of Life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}]",[{'cui': 'C0034380'}],,0.0187779,"The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology.","[{'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Heutte', 'Affiliation': 'UNIROUEN, CETAPS EA 3832, University of Normandy, Mont Saint-Aignan, France. natacha.heutte@univ-rouen.fr.'}, {'ForeName': 'Moumainn', 'Initials': 'M', 'LastName': 'Abouzayd', 'Affiliation': 'Head and Neck Department, University of Tours, Tours, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Plisson', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Trocmé', 'Affiliation': ""Lille University, UMR CNRS 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Rue du Barreau 59653, 60149, Villeneuve d'Ascq cedex, BP, France.""}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Seillier', 'Affiliation': ""CERFEP, CARSAT, Villeneuve d'Ascq cedex, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Christophe', 'Affiliation': ""Lille University, UMR CNRS 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Rue du Barreau 59653, 60149, Villeneuve d'Ascq cedex, BP, France.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Guittet', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grandazzi', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Babin', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1380-2']
1463,29926433,The Effect of Educational Intervention Based on PRECEDE Model on Promoting Skin Cancer Preventive Behaviors in High School Students.,"School-based education programs can be an effective way of educating adolescents about the dangers of exposure to sunlight and about preventive measures against this exposure and its relation to skin cancer. The aim of this study is to survey the effect of educational intervention based on the PRECEDE model on promoting skin cancer preventive behaviors in high school students of Fasa City, Fars Province, Iran. In this quasi-experimental study, 300 students (150 in experimental group and 150 in control group) in Fasa City, Fars Province, Iran, were selected in 2016-2017. The educational intervention for the experimental group consisted of six training sessions. A questionnaire consisting of demographic information, PRECEDE constructs (knowledge, attitude, self-efficacy, enabling factors, and social support), was used to measure skin cancer preventive behaviors before and 4 months after the intervention. Data were analyzed using SPSS 22 and paired t test, independent t test, and chi-square test at a significance level of p < 0.05. The mean age of the students was 16.05 ± 1.76 years in the experimental group and 16.20 ± 1.71 years in the control group. Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group. This study showed the effectiveness of the intervention based on the PRECEDE constructs in adoption of skin cancer preventive behaviors in 4 months post-intervention in students. Hence, this model can act as a framework for designing and implementing educational intervention for the prevention of skin cancer.",2019,"Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group.","['The mean age of the students was 16.05\u2009±\u20091.76\xa0years in the experimental group and 16.20\u2009±\u20091.71\xa0years in the control group', 'skin cancer preventive behaviors in 4\xa0months post-intervention in students', 'High School Students', '300 students (150 in experimental group and 150 in control group) in Fasa City, Fars Province, Iran, were selected in 2016-2017', 'high school students of Fasa City, Fars Province, Iran']","['Educational Intervention', 'educational intervention', 'School-based education programs']","['knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors', 'Skin Cancer Preventive Behaviors', 'skin cancer preventive behaviors']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}, {'cui': 'C0037438'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",300.0,0.0173,"Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khani Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran. khani_1512@yahoo.com.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1376-y']
1464,29886779,Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes?,"Objective:  To investigate whether intact umbilical cord milking (I-UCM) can aggravate infection or result in other undesirable complications in preterm infants with premature prolonged rupture of membranes (PPROM). Methods:  Neonates vaginally delivered between 28 and 37 weeks' gestation and complicated by PPROM before birth were randomly divided into two groups according to the cord clamping procedure: I-UCM before clamping and immediate cord clamping (ICC). Various parameters of the study participants were compared between the two groups. Results:  Of 102 preterm infants, 48 and 54 were randomly allocated to the I-UCM and ICC groups, respectively. There were no significant differences between the two groups regarding hematological parameters (platelet count, white blood count, neutrophil ratio, and C-reactive protein) or neonatal outcomes (probable or certain neonatal infection, respiratory distress syndrome, necrotizing enterocolitis, and intraventricular hemorrhage) ( p  > .05). However, preterm neonates in the I-UCM group had higher serum hemoglobin and hematocrit levels ( p  < .05) and received fewer blood transfusions ( p  < .05) than those in the ICC group. Conclusion:  Milking the umbilical cord to a preterm neonate with PPROM will not aggravate neonatal infection or result in other undesirable complications. This simple procedure will improve hemoglobin values and hematocrit levels and may lessen the need for transfusion during the neonatal period.",2020,"There were no significant differences between the two groups regarding hematological parameters (platelet count, white blood count, neutrophil ratio, and C-reactive protein) or neonatal outcomes (probable or certain neonatal infection, respiratory distress syndrome, necrotizing enterocolitis, and intraventricular hemorrhage) (p > .05).","['102 preterm infants, 48 and 54', 'preterm infants with premature prolonged rupture of membranes', 'preterm infants with premature prolonged rupture of membranes (PPROM', ""Neonates vaginally delivered between 28 and 37 weeks' gestation and complicated by PPROM before birth""]","['intact umbilical cord milking (I-UCM', 'I-UCM before clamping and immediate cord clamping (ICC', 'cord clamping procedure']","['serum hemoglobin and hematocrit levels', 'blood transfusions', 'hematological parameters (platelet count, white blood count, neutrophil ratio, and C-reactive protein) or neonatal outcomes (probable or certain neonatal infection, respiratory distress syndrome, necrotizing enterocolitis, and intraventricular hemorrhage', 'hemoglobin values and hematocrit levels']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C3541213', 'cui_str': 'Rupture of amniotic sac 24 OR more hours before labor'}, {'cui': 'C0729264', 'cui_str': 'PPROM'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0854706', 'cui_str': 'Neonatal infection'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",102.0,0.070931,"There were no significant differences between the two groups regarding hematological parameters (platelet count, white blood count, neutrophil ratio, and C-reactive protein) or neonatal outcomes (probable or certain neonatal infection, respiratory distress syndrome, necrotizing enterocolitis, and intraventricular hemorrhage) (p > .05).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ""Department of Neonatal Intensive Care Unit (NICU), Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}, {'ForeName': 'Qian-Ling', 'Initials': 'QL', 'LastName': 'Dai', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}, {'ForeName': 'Xiao-Qin', 'Initials': 'XQ', 'LastName': 'Gan', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Women and Children's Central Hospital, Chengdu City, People's Republic of China.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1487947']
1465,29883769,Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics.,"PURPOSE


Describe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study.
DESIGN


Prospective, multi-center, randomized, double-masked ""real-world"" clinical trial assessing efficacy and safety of oral omega-3 (ω3) supplementation for the treatment of dry eye disease (DED).
METHODS


RESULTS: Mean age of participants was 58.0 ± 13.2 years. Mean OSDI score at baseline was 44.4 ± 14.2. Mean conjunctival staining score (scale 0-6) was 3.0 ± 1.4, corneal staining score (scale 0-15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min.
CONCLUSIONS


DREAM© participants mirror real world patients who seek intervention for their DED-related symptoms despite their current treatments. Results regarding the efficacy of omega-3 supplementation will be helpful to clinicians and patients with moderate to severe DED who are considering omega-3 as a treatment. This trial design may be a model for future RCT's on nutritional supplements and DED treatments seeking to provide useful information for clinical practice.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT02128763.",2018,"Mean conjunctival staining score (scale 0-6) was 3.0 ± 1.4, corneal staining score (scale 0-15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min.
","['participants in the DRy Eye Assessment and Management', 'Mean age of participants was 58.0\u202f±\u202f13.2\u202fyears', 'dry eye disease (DED']","['oral omega-3 (ω3) supplementation', 'DREAM', 'omega-3 supplementation']","['Mean conjunctival staining score', 'Mean OSDI score', 'corneal staining score', 'Dry Eye Assessment and Management (DREAM©']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}]",,0.287712,"Mean conjunctival staining score (scale 0-6) was 3.0 ± 1.4, corneal staining score (scale 0-15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min.
","[{'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Asbell', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Ophthalmology, 1468 Madison Ave, Box 1183, New York, NY 10029, United States. Electronic address: penny.asbell@mssm.edu.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'University of Pennsylvania, Department of Ophthalmology, 3535 Market Street, Suite 700, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peskin', 'Affiliation': 'University of Pennsylvania, Department of Ophthalmology, 3535 Market Street, Suite 700, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Vatinee Y', 'Initials': 'VY', 'LastName': 'Bunya', 'Affiliation': 'University of Pennsylvania, Department of Ophthalmology, 3535 Market Street, Suite 700, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Kuklinski', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Ophthalmology, 1468 Madison Ave, Box 1183, New York, NY 10029, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.06.002']
1466,29891223,"Clinical and metabolic response to probiotic administration in people with Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND & AIMS


The investigation was done to assess the impacts of probiotic supplementation on movement and metabolic parameters in individuals with Parkinson's disease (PD).
METHODS


The study is randomized, double-blind, placebo-controlled clinical trial, which was done in sixty people with PD. Individuals were randomly divided into two groups in order to take either 8 × 10 9  CFU/day probiotic or placebo (n = 30 each group) that lasted 12 weeks. The Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was recorded at pre- and post-intervention.
RESULTS


Compared with the placebo, consuming probiotic decreased MDS-UPDRS (-4.8 ± 12.5 vs. +3.8 ± 13.0, P = 0.01). Probiotic supplementation also reduced high-sensitivity C-reactive protein (-1.6 ± 2.5 vs. +0.1 ± 0.3 mg/L, P < 0.001) and malondialdehyde (-0.2 ± 0.3 vs. +0.1 ± 0.3 μmol/L, P = 0.006), and enhanced glutathione levels (+40.1 ± 81.5 vs. -12.1 ± 41.7 μmol/L, P = 0.03) in comparison with the placebo. Additionally, probiotic consumption resulted in a statistically significant reduction in insulin levels (-2.1 ± 3.4 vs. +1.5 ± 5.1 μIU/mL, P = 0.002) and insulin resistance (-0.5 ± 0.9 vs. +0.4 ± 1.2, P = 0.002), and a statistically significant rise in insulin sensitivity (+0.01 ± 0.02 vs. -0.006 ± 0.02, P = 0.01) in comparison with the placebo. Probiotic intake had no any significant impact on other metabolic profiles.
CONCLUSIONS


Our study evidenced that 12 weeks of probiotic consumption by individuals with PD had useful impacts on MDS-UPDRS and few metabolic profiles. Registered under ClinicalTrials.gov Identifier no. http://www.irct.ir: IRCT2017082434497N4.",2019,"Probiotic supplementation also reduced high-sensitivity C-reactive protein (-1.6 ± 2.5 vs. +0.1 ± 0.3 mg/L, P ","[""people with Parkinson's disease"", ""individuals with Parkinson's disease (PD"", 'sixty people with PD']","['CFU/day probiotic or placebo', 'probiotic administration', 'placebo', 'Probiotic supplementation', 'probiotic supplementation']","['insulin sensitivity', 'insulin levels', ""Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'insulin resistance', 'MDS-UPDRS', 'metabolic profiles', 'enhanced glutathione levels', 'malondialdehyde', 'high-sensitivity C-reactive protein']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",60.0,0.615407,"Probiotic supplementation also reduced high-sensitivity C-reactive protein (-1.6 ± 2.5 vs. +0.1 ± 0.3 mg/L, P ","[{'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Shokoofeh', 'Initials': 'S', 'LastName': 'Borzabadi', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Shahrbanoo', 'Initials': 'S', 'LastName': 'Oryan', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mafi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_r@yahoo.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.018']
1467,31634648,UCBG 2-04: Long-term results of the PACS 04 trial evaluating adjuvant epirubicin plus docetaxel in node-positive breast cancer and trastuzumab in the human epidermal growth factor receptor 2-positive subgroup.,"PURPOSE


We conducted a double-randomised phase III trial to evaluate a concomitant taxane-anthracycline regimen in node-positive breast cancer and the efficacy of trastuzumab in the human epidermal growth factor receptor 2 (HER2)-positive subpopulation.
METHODS


A total of 3010 patients with node-positive breast cancer were randomly assigned to receive 6 cycles of 500 mg/m 2  of fluorouracil, 100 mg/m 2  of epirubicin and 500 mg/m 2  of cyclophosphamide (FEC) or 75 mg/m 2  of epirubicin and 75 mg/m 2  of docetaxel (ED). Patients with HER2-positive tumours were secondary randomly assigned to either trastuzumab or observation. The primary end-point was disease-free survival (DFS) in the two chemotherapy arms.
RESULTS


After a 115-month median follow-up, DFS was not significantly better in the ED arm (DFS: 70%, 95% confidence interval [CI]: 67-72) than in the FEC arm (DFS: 68%, 95% CI: 65-70; hazard ratio [HR] = 0.88, 95% CI: 0.77-1.01; p = 0.064). The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = 0.97, 95% CI: 0.81-1.16; p = 0.729). ED appeared more toxic. In the 528 HER2-positive subset, there was trend for a higher DFS, in the intention-to-treat population, in the trastuzumab arm (DFS: 68%, 95% CI: 61-74) than in the observation arm (DFS: 60%, 95% CI: 54-66; HR = 0.77, 95% CI: 0.57-1.03; p = 0.079). In the per-protocol population, DFS was significantly higher in the trastuzumab arm (DFS: 70%, 95% CI: 63-76) than in the observation arm (DFS: 59%, 95% CI: 53-65; HR = 0.69, 95% CI: 0.51-0.94; p = 0.0156). The OS was not different between these 2 arms.
CONCLUSION


This study did not show superiority of the concomitant anthracycline-taxane arm which was more toxic in high-risk node-positive breast cancer patients. Long-term results of the HER2-positive subpopulation are in line with those of the other adjuvant trastuzumab trials but quantitatively less pronounced mostly because of lack of power.",2019,"The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = ","['Patients with HER2-positive tumours', 'high-risk node-positive breast cancer patients', 'node-positive breast cancer', '3010 patients with node-positive breast cancer', 'node-positive breast cancer and trastuzumab in the human epidermal growth factor receptor 2-positive subgroup']","['trastuzumab or observation', 'fluorouracil,\xa0100\xa0mg/m 2  of epirubicin and\xa0500\xa0mg/m 2  of cyclophosphamide (FEC) or 75', 'concomitant taxane-anthracycline regimen', 'trastuzumab', 'epirubicin plus docetaxel', 'concomitant anthracycline-taxane', 'epirubicin and 75\xa0mg/m 2  of docetaxel (ED']","['disease-free survival (DFS', 'DFS', 'toxic']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",3010.0,0.18372,"The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = ","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Medical Oncology Department, Institut du Cancer, IRCM, INSERM, Univ Montpellier, France. Electronic address: veronique.dhondt@icm.unicancer.fr.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Canon', 'Affiliation': 'Medical Oncology Department, Clinique Notre Dame, Charleroi, Belgium.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Roca', 'Affiliation': 'Biometrics Unit, Institut du Cancer, Montpellier, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Medical Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Medical Oncology Department, Institut Curie & St Cloud, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Le Du', 'Affiliation': 'Medical Oncology Department, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Medical Oncology Department, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmoulins', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Medical Oncology Department, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debled', 'Affiliation': 'Medical Oncology Department, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rios', 'Affiliation': 'Medical Oncology Department, Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Medical Oncology Department, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serin', 'Affiliation': 'Medical Oncology Department, Institut Sainte-Catherine, Avignon, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""Medical Oncology Department, Centre Armoricain de Radiothérapie, d'Imagerie et d'Oncologie, Plérin, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Piot', 'Affiliation': 'Medical Oncology Department, Centre-Médico Chirurgical Les Ormeaux, Le Havre, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Medical Oncology Department, Institut Curie, Centre René Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dohollou', 'Affiliation': 'Medical Oncology Department, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Orfeuvre', 'Affiliation': 'Medical Oncology Department, CH - Hôpital de Fleyriat, Bourg-en-Bresse, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Lemonnier', 'Affiliation': 'UCBG, R&D UNICANCER, Paris, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Medical Oncology Department, IUCT Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Medical Oncology Department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Dalenc', 'Affiliation': 'Medical Oncology Department, IUCT Claudius Regaud, Toulouse, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.014']
1468,31523892,"Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial.","AIMS


Neladenoson bialanate is a partial adenosine A1 receptor agonist with demonstrated beneficial effects on cardiac function in animal models. We aimed to assess the dose-response effect of neladenoson bialanate on cardiac structure and function, clinical outcome, and safety in patients with heart failure (HF) with reduced ejection fraction (HFrEF).
METHODS AND RESULTS


PANTHEON was a dose-finding, phase IIb, randomized, double-blind, placebo-controlled trial conducted in 92 centres in 11 countries including 462 patients with chronic HFrEF, randomized to once daily oral dose of neladenoson bialanate (5, 10, 20, 30, and 40 mg) or placebo. The primary endpoints were change from baseline to 20 weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Mean age of the patients was 67 years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085 ng/L. After 20 weeks of treatment, there was no dose-effect of neladenoson bialanate on changes in NT-proBNP or LVEF (primary endpoints). No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints). There was a dose-dependent increase in creatinine and cystatin C, and a dose-dependent decrease in estimated glomerular filtration rate and heart rate.
CONCLUSIONS


In patients with chronic HFrEF, treatment with neladenoson bialanate was not associated with dose-dependent favourable effects on cardiac structure and function, cardiac risk markers, or clinical outcome but was associated with a dose-dependent decrease in renal function.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02992288.",2019,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","['92 centres in 11 countries including 462 patients with chronic HFrEF', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', 'patients with chronic heart failure with reduced ejection fraction', 'Mean age of the patients was 67\u2009years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085']","['placebo', 'neladenoson bialanate', 'partial adenosine A1 receptor agonist neladenoson bialanate']","['creatinine and cystatin C', 'Safety and efficacy', 'left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints', 'cardiac structure and function, clinical outcome, and safety', 'renal function', 'estimated glomerular filtration rate and heart rate', 'change from baseline to 20\u2009weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'cardiac structure and function, cardiac risk markers']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4519331', 'cui_str': 'neladenoson bialanate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2936550', 'cui_str': 'Adenosine A1 Receptor Agonists'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",462.0,0.557535,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Antonieta B', 'Initials': 'AB', 'LastName': 'Wirtz', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferreira', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'van der Laan', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1591']
1469,29794894,Agreement Between Bioelectrical Impedance and Dual-Energy X-Ray Absorptiometry to Track Changes in Fat-Free Mass After Resistance Training in Older Women.,"Nascimento, MA, Silva, DRP, Ribeiro, AS, Pina, FLC, Gerage, AM, Gobbo, LA, Mayhew, JL, and Cyrino, ES. Agreement between bioelectrical impedance and dual-energy x-ray absorptiometry to track changes in fat-free mass after resistance training in older women. J Strength Cond Res 34(6): 1700-1708, 2020-The aim of our study was to compare the agreement between bioelectrical impedance (BIA) and dual-energy X-ray absorptiometry (DXA) to track changes on fat-free mass (FFM) after a resistance training (RT) program in older women. Forty-three older women (65.2 ± 4.6 years, 59.5 ± 9.2 kg, 156.4 ± 6.0 cm, 24.3 ± 3.3 kg·m) participated in a RT intervention (12 weeks, 8 exercises, 2 sets, 10-15 repetitions, 3 nonconsecutive days per week). Fat-free mass changes were determined by a single-frequency BIA device (EQ1), 6 BIA prediction equations for older women (EQ2, EQ3, EQ4, EQ5, EQ6, and EQ7), and DXA. At pretraining, 3 equations overpredicted, and 3 underpredicted DXA FFM (F = 244.63, p < 0.001), although all equations had high correlations with DXA (r = 0.78-0.83). After training, 4 equations overpredicted and one underpredicted DXA FFM (F = 176.25, p < 0.001). Dual-energy X-ray absorptiometry detected significant gains in FFM (0.65 ± 0.82 kg; p < 0.05), as did EQ3 (0.55 ± 1.69 kg; p < 0.05), and EQ4 (0.61 ± 1.88 kg; p < 0.05), whereas the remaining equations did not indicate significant changes in FFM. Low correlations between FFM and equation change values suggest that single-frequency BIA-derived equations may not provide sufficient accuracy to track changes in FFM after 12 weeks of RT in older women.",2020,"Dual-energy X-ray absorptiometry detected significant gains in FFM (0.65 ± 0.82 kg; p < 0.05), as did EQ3 (0.55 ± 1.69 kg; p < 0.05), and EQ4 (0.61 ± 1.88 kg; p < 0.05), whereas the remaining equations did not indicate significant changes in FFM.","['Forty-three older women (65.2 ± 4.6 years, 59.5 ± 9.2 kg, 156.4 ± 6.0 cm, 24.3 ± 3.3 kg·m) participated in a', 'older women', 'Older Women']","['J Strength Cond Res XX(X', 'Resistance Training', 'resistance training (RT) program', 'RT intervention']","['bioelectrical impedance (BIA) and dual-energy X-ray absorptiometry (DXA', 'FFM', 'Nascimento, MA, Silva, DRP, Ribeiro, AS, Pina, FLC, Gerage, AM, Gobbo, LA, Mayhew, JL, and Cyrino, ES', 'Fat-Free Mass']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0445567', 'cui_str': 'Pina (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",43.0,0.0204784,"Dual-energy X-ray absorptiometry detected significant gains in FFM (0.65 ± 0.82 kg; p < 0.05), as did EQ3 (0.55 ± 1.69 kg; p < 0.05), and EQ4 (0.61 ± 1.88 kg; p < 0.05), whereas the remaining equations did not indicate significant changes in FFM.","[{'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Paraná State University-UNESPAR, Paranavaí, Paraná, Brazil.'}, {'ForeName': 'Danilo R P', 'Initials': 'DRP', 'LastName': 'Silva', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Paraná, Brazil.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Center for Research in Health Science, University of Northern Paraná-UNOPAR, Londrina, Paraná, Brazil.'}, {'ForeName': 'Fábio L C', 'Initials': 'FLC', 'LastName': 'Pina', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Paraná, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Gerage', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Paraná, Brazil.'}, {'ForeName': 'Luís A', 'Initials': 'LA', 'LastName': 'Gobbo', 'Affiliation': 'Department of Physical Education, School of Technology and Science, Sa[Combining Tilde]o Paulo State University, Presidente Prudente, Sa[Combining Tilde]o Paulo, Brazil.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Mayhew', 'Affiliation': 'Exercise Science Department, Truman State University, Kirksville, Missouri.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Paraná, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002581']
1470,31640847,Effects of ankle position during static stretching for the hamstrings on the decrease in passive stiffness.,"Static stretching is frequently performed to improve flexibility of the hamstrings, although the ankle position during hamstring stretching has not been fully investigated. We investigated the effects of ankle position during hamstring stretching on the decrease in passive stiffness. Fourteen healthy men performed static stretching for the hamstrings with the ankle dorsiflexed and plantar-flexed in a randomized order on different days. The hip was passively flexed to the maximum angle which could be tolerated without stretch pain with the knee fully extended; this was maintained for 5 min, with 1-min stretching performed in 5 sessions. Final angles and passive stiffness were measured before and after stretching. The final angle was defined as that formed by the tibia and horizontal plane when the knee was passively extended from hip and knee angles at 90° flexion to the maximum extension angle which could be tolerated without stretch pain. Passive stiffness was determined by the slope of torque-angle curve during the measurement of the final angle. The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed. The results suggest that passive stiffness decreases after stretching with the ankle planter-flexed but not after stretching with the ankle dorsiflexed, although the range of joint motion increases regardless of the ankle position during 5-min stretching for the hamstrings. These results indicate that static stretching should be performed with the ankle plantar-flexed when aiming to decrease passive stiffness of the hamstrings.",2019,"The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed.",['Fourteen healthy men performed'],"['static stretching', 'Static stretching']","['Final angles and passive stiffness', 'passive stiffness', 'Passive stiffness']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",14.0,0.0170038,"The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed.","[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan. Electronic address: nakao.sayaka.37s@kyoto-u.jp.'}, {'ForeName': 'Tome', 'Initials': 'T', 'LastName': 'Ikezoe', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Saeki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Japan; Research Fellow of the Japan Society for the Promotion of Science, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Umehara', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan; Research Fellow of the Japan Society for the Promotion of Science, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Ichihashi', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109358']
1471,31546498,Impact of fluidic parameters during phacoemulsification on the anterior vitreous face behavior: Experimental study.,"Purpose


To evaluate the eff ect of different aspiration flow rates (AFR) and bottle heights (BH) on vitreous face (AVF) during phacoemulsifi cation.
Methods


Experimental study in 20 porcine eyes. Transzonular viscodissection was performed between the posterior capsule(PC) and AVF to dissect out the Berger's space. Triamcinolone acetonide was injected into this space to aid visualization with ultrasound B-Scan(USG). Realtime USG was performed during phacoemulsifi cation. Eyes were divided randomly into-Group I: Low parameters(AFR = 20 cc/min, BH = 90 cm, vacuum = 400 mmHg),and Group II: High parameters (AFR = 40 cc/min, BH = 110 cm, vacuum=650 mm Hg).
Results


15 eyes were analysed (8 in Group I; 7 in Group II). In all eyes, forward and backward movement of the PC was seen when going from foot position 0 to 1, or on occlusion break. Amplitude of these movements was much greater in Group II compared to Group I. There was no PC rupture in either group. In 2 of the 7 eyes in Group II, USG showed a sudden, spontaneous dispersion appearance of sono-opaque echoes in the vitreous cavity alongwith disappearance of the well-defi ned, crescentic stained space despite an intact PC. This suggests rupture of the AVF, leading to dispersion of the triamcinolone into the entire vitreous cavity. No AVF rupture was seen in Group I.
Conclusion


We report a rarely described entity of AVF rupture with intact PC. The use of high AFR and BH may have clinically invisible detrimental consequences to the anterior vitreous face.",2019,There was no PC rupture in either group.,['20 porcine eyes'],"['Triamcinolone acetonide', 'triamcinolone', 'aspiration flow rates (AFR) and bottle heights (BH']","['PC rupture', 'sudden, spontaneous dispersion appearance of sono-opaque echoes', 'AVF rupture']","[{'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}]","[{'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C1261286', 'cui_str': 'Opaque (qualifier value)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}]",20.0,0.0129039,There was no PC rupture in either group.,"[{'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Abhay R', 'Initials': 'AR', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Bilgic', 'Affiliation': 'Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_465_19']
1472,31573911,Tailored Web-Based Information for Younger and Older Patients with Cancer: Randomized Controlled Trial of a Preparatory Educational Intervention on Patient Outcomes.,"BACKGROUND


Many patients with cancer, including older patients (aged ≥65 years), consult the Web to prepare for their doctor's visit. In particular, older patients have varying needs regarding the mode in which information is presented (eg, via textual, visual, or audiovisual modes) owing to age-related sensory (eg, impaired vision and hearing) and cognitive decline (eg, reduced processing speed). Therefore, Web-based information targeted at older patient populations is likely to be used and processed more effectively, and evaluated more positively, when tailored to age-related capabilities and preferences. This, in turn, may benefit patient outcomes.
OBJECTIVE


This randomized controlled trial tested the effects of a Web-based tailored educational intervention among newly diagnosed younger (<65 years) and older (≥65 years) patients with cancer. We compared the intervention group who viewed a mode-tailored website (ie, enabling patients to tailor information using textual, visual, and audiovisual modes) with 3 control groups view a nontailored website (ie, text only, text with images, and text with videos). We examined website experience outcomes (ie, website satisfaction, website involvement, knowledge, anxiety, and communication self-efficacy) and consultation experience outcomes (ie, question asking during consultation, anxiety, and information recall).
METHODS


Patients from a multidisciplinary outpatient clinic (N=232) viewed a mode-tailored or nontailored website as preparation before their hospital consultations to discuss diagnosis and treatment. Data were collected before (T1), during (T2), and after (T3) visitation. Website experience outcomes were assessed with questionnaires (T1). Patients' question asking was coded from videotaped consultations, and anxiety was assessed through a questionnaire (T2). Telephone interviews were conducted to assess knowledge acquired from the website before (T1) and after consultation (T3), and information recall from the consultation (T3).
RESULTS


The preparatory website was well used across all conditions (mean 34 min). Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only). This pattern was not found in older patients. Mode tailoring yielded no other significant differences in patient outcomes. Regression analyses showed that website involvement (beta=.15; P=.03) and, to a lesser extent, website satisfaction (beta=.15; P=.05) positively associated with knowledge before consultation (T1). In turn, higher knowledge before consultation (beta=.39; P<.001), together with time on the website (beta=.21; P=.002; T1), predicted information recall from consultations (T3). Patients with higher knowledge before consultation (T1) also reported higher knowledge from the website afterward (T3; beta=.22; P=.003).
CONCLUSIONS


Offering preparatory online information before consultations benefits information processing and patient outcomes of both younger and older newly diagnosed patients with cancer. Younger patients benefit even more when information is offered in a mode-tailored manner. We discuss the theoretical, methodological, and practical implications for patient-provider communication research in an electronic health era.
CLINICAL TRIAL


Netherlands Trial Register NTR5904; https://www.trialregister.nl/trial/5750.",2019,Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only).,"['Patients from a multidisciplinary outpatient clinic (N=232) viewed a', 'patients with cancer, including older patients (aged ≥65 years', 'Younger and Older Patients with Cancer', 'newly diagnosed younger (<65 years) and older (≥65 years) patients with cancer', 'younger and older newly diagnosed patients with cancer', 'older patients']","['Web-based tailored educational intervention', 'mode-tailored or nontailored website', 'intervention group who viewed a mode-tailored website (ie, enabling patients to tailor information using textual, visual, and audiovisual modes) with 3 control groups view a nontailored website (ie, text only, text with images, and text with videos', 'Preparatory Educational Intervention']","['website experience outcomes (ie, website satisfaction, website involvement, knowledge, anxiety, and communication self-efficacy) and consultation experience outcomes ', 'ie, question asking during consultation, anxiety, and information recall', 'website satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",,0.0749128,Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only).,"[{'ForeName': 'Minh Hao', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ellen Ma', 'Initials': 'EM', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bol', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eugène F', 'Initials': 'EF', 'LastName': 'Loos', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hanneke Wm', 'Initials': 'HW', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Geijsen', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Kristien Maj', 'Initials': 'KM', 'LastName': 'Tytgat', 'Affiliation': 'Department of Gastroenterology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Julia Cm', 'Initials': 'JC', 'LastName': 'van Weert', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14407']
1473,31579014,Diminishing Effects After Recurrent Use of Self-Guided Internet-Based Interventions in Depression: Randomized Controlled Trial.,"BACKGROUND


Self-guided internet-based interventions have several advantages over guided interventions and are generally effective in treating psychiatric symptoms.
OBJECTIVE


We aimed to investigate whether the use of a new self-guided internet-based intervention (MOOD) would lead to a significant reduction in depressive symptoms compared with a care-as-usual (CAU) control group in a sample of individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial.
METHODS


A total of 125 individuals were randomized to the intervention condition (MOOD) and received access to the intervention for a period of six weeks or a CAU group. After six weeks, all participants were invited to take part in the post assessment. The Beck Depression Inventory-II served as the primary outcome.
RESULTS


Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD. Subsequent moderation analyses suggested that those individuals who had less experience with psychotherapy benefitted to a greater extent compared with those with more experience.
CONCLUSIONS


Self-guided internet-based interventions are deemed a suitable first-step approach to the treatment of depression. However, our results indicate that they are more efficacious in those with less psychotherapy experience.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03795480; http://clinicaltrials.gov/ct2/show/NCT03795480.",2019,Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD.,"['individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial', '125 individuals']","['Self-Guided Internet-Based Interventions', 'new self-guided internet-based intervention (MOOD']","['depressive symptoms', 'depressive symptomatology']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",125.0,0.164112,Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD.,"[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Bücker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Schnakenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Karyotaki', 'Affiliation': 'Department of Clinical Psychology, VU Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of medical Internet research,['10.2196/14240']
1474,29764315,Effects of Egg Consumption and Choline Supplementation on Plasma Choline and Trimethylamine-N-Oxide in a Young Population.,"Background : Plasma trimethylamine-N-oxide (TMAO) concentrations have been associated with cardiovascular disease risk. Eggs are a rich source of choline, which is a precursor of TMAO. Objective:  The effects of egg intake versus daily choline supplementation were evaluated on plasma choline and TMAO in a young, healthy population. Methods:  Thirty participants (14 males, 16 females; 25.6 ± 2.3 years; body mass index = 24.3 ± 2.9 kg/m 2 ) were enrolled in this 13-week crossover intervention. After a 2-week washout, participants were randomized to consume either 3 eggs/d or a choline bitartrate supplement (∼ 400 mg choline total in eggs or supplement) for 4 weeks. Following a 3-week washout, participants were switched to the alternate treatment. Dietary records were measured at the end of each period. Plasma TMAO and choline were measured at baseline and at the end of each dietary intervention. Gene expression of scavenger receptors associated with plasma TMAO were quantified at the end of each intervention. Results:  Compared to the choline supplement, intake of total fat, cholesterol, selenium, and vitamin E were higher ( p  < 0.05), whereas carbohydrate intake was lower ( p  < 0.001) with consumption of 3 eggs/d. Fasting plasma choline increased 20% ( p  = 0.023) with egg intake, while no changes were observed with choline supplementation. Plasma TMAO levels were not different between dietary treatments or compared to baseline. Conclusions:  Dietary choline appears to be more bioavailable via egg consumption when compared to a choline supplement. Plasma TMAO concentrations were not affected in healthy participants after 4 weeks of taking ∼400 mg/d choline either via eggs or choline supplementation.",2018,"Fasting plasma choline increased 20% (p = 0.023) with egg intake, while no changes were observed with choline supplementation.","['Young Population', 'young, healthy population', 'Thirty participants (14 males, 16 females; 25.6 ± 2.3\xa0years; body mass index = 24.3 ± 2.9\xa0kg/m 2 ']","['Egg Consumption and Choline Supplementation', 'egg intake versus daily choline supplementation', 'choline bitartrate supplement (∼ 400\xa0mg choline total in eggs or supplement', 'Plasma trimethylamine-N-oxide ']","['Plasma Choline and Trimethylamine-N-Oxide', 'intake of total fat, cholesterol, selenium, and vitamin E', 'Plasma TMAO and choline', 'plasma choline and TMAO', 'Plasma TMAO levels', 'Plasma TMAO concentrations', 'Fasting plasma choline', 'carbohydrate intake']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556089', 'cui_str': 'Choline supplementation (product)'}, {'cui': 'C0556195', 'cui_str': 'Egg intake (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008408', 'cui_str': 'Choline Bitartrate'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",30.0,0.0494062,"Fasting plasma choline increased 20% (p = 0.023) with egg intake, while no changes were observed with choline supplementation.","[{'ForeName': 'Bruno S', 'Initials': 'BS', 'LastName': 'Lemos', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT, US.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Medina-Vera', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT, US.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, US.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, US.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT, US.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1466213']
1475,31560027,Lower-Extremity Torque Capacity and Physical Function in Mobility-Limited Older Adults.,"OBJECTIVES


Skeletal muscle weakness and an increase in fatigability independently contribute to age-related functional decline. The objective of this study was to examine the combined contribution of these deficiencies (i.e., torque capacity) to physical function, and then to assess the functional implications of progressive resistance training (PRT) mediated-torque capacity improvements in mobility-limited older adults.
DESIGN


Randomized controlled trial.
SETTING


Exercise laboratory on the Health Sciences campus of an urban university.
PARTICIPANTS


Seventy mobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (~79 yrs).
INTERVENTION


Progressive resistance training or home-based flexibility 3 days/week for 12 weeks.
MEASUREMENTS


Torque capacity was defined as the sum of peak torques from an isokinetic knee extension fatigue test. Relationships between torque capacity and performance-based and patient-reported functional measures before and after PRT were examined using partial correlations adjusted for age, sex, and body mass index.
RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively. PRT-mediated torque capacity improvements were paralleled by increases (P<0.05) in self-reported activity participation (+20%) and advanced lower extremity function (+7%), and associated (P<0.05) with a reduction in activity limitations (r=0.44) and an improved SPPB score (r=0.32).
CONCLUSION


Skeletal muscle torque capacity, a composite of strength and fatigue, may be a proximal determinant of physical function in mobility-limited older individuals. To more closely replicate the musculoskeletal demands of real-life tasks, future studies are encouraged to consider the combined interaction of distinct skeletal muscle faculties to overall functional ability in older adults.",2019,"RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively.","['Seventy mobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (~79 yrs', 'older adults', 'Exercise laboratory on the Health Sciences campus of an urban university', 'mobility-limited older adults', 'Mobility-Limited Older Adults']","['Progressive resistance training or home-based flexibility 3 days/week for 12 weeks', 'progressive resistance training (PRT']","['activity participation', 'Torque capacity', 'PRT-mediated torque capacity improvements', 'activity limitations', 'advanced lower extremity function', 'SPPB score', 'Lower-Extremity Torque Capacity and Physical Function', 'peak torques from an isokinetic knee extension fatigue test']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",70.0,0.0312026,"RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively.","[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Gregory J. Grosicki, Ph.D., Department of Health Sciences and Kinesiology, Biodynamics and Human Performance Center, Georgia Southern University (Armstrong Campus), 11935 Abercorn Street, Savannah, GA, 31419. Phone: (912) 344-3317. Fax: (912) 344-3490. Email: ggrosicki@georgiasouthern.edu.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Englund', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': ''}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1232-8']
1476,29779435,Class Percentage of Students With Reading Difficulties on Content Knowledge and Comprehension.,"We examined the efficacy of a content acquisition and reading comprehension intervention implemented in eighth-grade social studies classrooms. Using a within-teacher randomized control design, 18 eighth-grade teachers' social studies classes were randomly assigned to a treatment or comparison condition. Teachers taught all their classes (treatment and comparison) using the same content; however, in the treatment classes, teachers used instructional practices that included comprehension canopy, essential words, knowledge acquisition, and team-based learning. Students with reading comprehension difficulties in the treatment classes ( n  = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n  = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension. In addition, the proportion of students with reading comprehension difficulties in classes moderated outcomes for content knowledge acquisition and content reading comprehension.",2019,Students with reading comprehension difficulties in the treatment classes ( n = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension.,"[""18 eighth-grade teachers' social studies classes"", 'eighth-grade social studies classrooms', 'Students with reading comprehension difficulties in the treatment classes ( n\u2009= 359) outperformed students with reading comprehension difficulties in the comparison classes ( n\u2009= 331']",['content acquisition and reading comprehension intervention'],['content knowledge acquisition and content reading comprehension'],"[{'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",359.0,0.0160682,Students with reading comprehension difficulties in the treatment classes ( n = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Anna-Mária', 'Initials': 'AM', 'LastName': 'Fall', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Wanzek', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Swanson', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Leticia R', 'Initials': 'LR', 'LastName': 'Martinez', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}]",Journal of learning disabilities,['10.1177/0022219418775117']
1477,31533539,Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study.,"Background:  Long-acting (LA) injectable antiretroviral therapy (ART) is a novel modality currently under development as an alternative to daily oral ART. Objective:  The LATTE-2 study (ClinicalTrials.gov identifier NCT02120352) showed that cabotegravir LA + rilpivirine LA maintained virologic suppression through 96 weeks and included further exploration of patient-reported treatment outcomes with an LA injectable form of treatment. Methods:  Two-hundred and eighty-six virologically suppressed participants on oral cabotegravir + abacavir/lamivudine once-daily tablets (induction period) were randomized to cabotegravir LA + rilpivirine LA once every 4 weeks ( n  = 115), once every 8 weeks ( n  = 115), or the continuation of the oral tablet regimen ( n  = 56) during the maintenance period. Patient-reported outcome measures included the HIV Medications Questionnaire (HIVMQ) and the HIV Treatment Satisfaction Questionnaire status (HIVTSQ[s]) and change (HIVTSQ[c]) versions at prespecified study visits through Week 96 of the randomized maintenance period. Results:  Most participants in the LA injectable groups reported injection-site-related adverse events; however, participants in the 4-week (median HIVTSQ[s] total score, 63.5; post hoc  P  = 0.02) and 8-week (65.0; post hoc  P  < 0.001) LA injectable groups were significantly more satisfied with treatment than participants in the oral maintenance group (60.0) at Week 96. This was consistent with results from the HIVTSQ[c] at Week 32, which revealed that participants in both LA groups were significantly more satisfied with therapy compared with patients receiving oral ART (both post hoc  P  < 0.001). Conclusion:  Participants who received LA injectable therapy had high levels of treatment satisfaction and favorably viewed convenience and lifestyle-related aspects of the therapy.",2019,LA injectable groups were significantly more satisfied with treatment than participants in the oral maintenance group (60.0) at Week 96.,"['once-daily tablets (induction period', 'Two-hundred and eighty-six virologically suppressed participants on oral cabotegravir\u2009', 'HIV-1 infection']","['cabotegravir LA\u2009+\u2009rilpivirine LA', ':  Long-acting (LA) injectable antiretroviral therapy (ART', 'LA injectable therapy', 'cabotegravir\u2009+\u2009rilpivirine long-acting injections', 'abacavir/lamivudine', 'LA injectable form of treatment']","['injection-site-related adverse events', 'tolerability and acceptability', 'HIV Medications Questionnaire (HIVMQ) and the HIV Treatment Satisfaction Questionnaire status (HIVTSQ[s]) and change (HIVTSQ[c]) versions']","[{'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4310385'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]","[{'cui': 'C4310385'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",286.0,0.117779,LA injectable groups were significantly more satisfied with treatment than participants in the oral maintenance group (60.0) at Week 96.,"[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'ViiV Healthcare, London, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'Hospital Universitario 12 de Octubre, UCM, (imas12), Madrid, Spain.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ""Southern California Men's Medical Group, West Hollywood, CA, USA.""}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Ramgopal', 'Affiliation': 'Midway Immunology and Research Center, Fort Pierce, FL, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'LeBlanc', 'Affiliation': 'Immunodeficiency Service Division of Hematology, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Jaeger', 'Affiliation': 'HIV Research and Clinical Care Centre, MUC Research GmbH and MVZ Karlsplatz, Munich, Germany.'}, {'ForeName': 'Viviam', 'Initials': 'V', 'LastName': 'Canon', 'Affiliation': 'Division of Janssen Pharmaceutica NV, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dorey', 'Affiliation': 'GlaxoSmithKline, Mississauga, Ontario, Canada.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mrus', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Spreen', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",HIV research & clinical practice,['10.1080/25787489.2019.1661696']
1478,31498121,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Teprenone in Patients with Alzheimer's Disease.","BACKGROUND


Teprenone (geranylgeranylacetone), an anti-ulcer agent, has been reported to inhibit amyloid-β increase, senile plaque formation, and neuronal degeneration, and improve memory in mouse models of Alzheimer's disease (AD).
OBJECTIVE


We conducted a randomized, double-blind, placebo-controlled study to ascertain teprenone's therapeutic ability for AD.
METHODS


Patients with mild to moderate AD, with a Mini-Mental State Examination (MMSE) score of 13 to 26, were randomly allocated into two groups depending on the administered drug: donepezil +  placebo (placebo group) and donepezil + teprenone (teprenone group). The primary and secondary endpoints included changes in scores of the Japanese version of the AD Assessment Scale-cognitive subscale (ADAS-J cog) and other evaluations, respectively, including MMSE scores, during a 12-month period after the first administration.
RESULTS


Forty-two and thirty-seven patients were allocated to the teprenone and placebo groups, respectively. ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861). However, MMSE scores significantly improved in the teprenone group (placebo, - 1.2±0.5; teprenone, 0.2±0.5; p = 0.044). Subgroup analysis considering the severity of medial temporal area atrophy revealed that this improvement by teprenone was significant in patients with mild (p = 0.013) but not with severe atrophy (p = 0.611). Adverse events were observed in 17.8 and 10.4% of patients in the placebo and teprenone group, respectively.
CONCLUSION


Teprenone may be effective for AD when administered before atrophy progression in the medial temporal areas.
TRIAL REGISTRATION


UMIN ID: UMIN000016843.",2019,"ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861).","[""Patients with Alzheimer's Disease"", 'Forty-two and thirty-seven patients', 'Patients with mild to moderate AD, with a Mini-Mental State Examination (MMSE) score of 13 to 26']","['Placebo', 'teprenone and placebo', 'Teprenone (geranylgeranylacetone', 'Teprenone', 'placebo', 'donepezil\u200a+ \u200aplacebo (placebo group) and donepezil\u200a+\u200ateprenone (teprenone group']","['changes in scores of the Japanese version of the AD Assessment Scale-cognitive subscale (ADAS-J cog) and other evaluations, respectively, including MMSE scores', 'ADAS-J cog score changes', 'Adverse events', 'severity of medial temporal area atrophy', 'MMSE scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061231', 'cui_str': 'teprenone'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",79.0,0.658891,"ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861).","[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Neurosurgery, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Yoshinaga', 'Affiliation': 'Division of Clinical Application, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Juntaro', 'Initials': 'J', 'LastName': 'Matsuzaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190305']
1479,31506292,Effects of Selonsertib in Patients with Diabetic Kidney Disease.,"BACKGROUND


Apoptosis signal-regulating kinase 1 (ASK1) activation in glomerular and tubular cells resulting from oxidative stress may drive kidney disease progression. Findings in animal models identified selonsertib, a selective ASK1 inhibitor, as a potential therapeutic agent.
METHODS


In a phase 2 trial evaluating selonsertib's safety and efficacy in adults with type 2 diabetes and treatment-refractory moderate-to-advanced diabetic kidney disease, we randomly assigned 333 adults in a 1:1:1:1 allocation to selonsertib (oral daily doses of 2, 6, or 18 mg) or placebo. Primary outcome was change from baseline eGFR at 48 weeks.
RESULTS


Selonsertib appeared safe, with no dose-dependent adverse effects over 48 weeks. Although mean eGFR for selonsertib and placebo groups did not differ significantly at 48 weeks, acute effects related to inhibition of creatinine secretion by selonsertib confounded eGFR differences at 48 weeks. Because of this unanticipated effect, we used piecewise linear regression, finding two dose-dependent effects: an acute and more pronounced eGFR decline from 0 to 4 weeks (creatinine secretion effect) and an attenuated eGFR decline between 4 and 48 weeks (therapeutic effect) with higher doses of selonsertib. A post hoc analysis (excluding data for 20 patients from two sites with Good Clinical Practice compliance-related issues) found that between 4 and 48 weeks, rate of eGFR decline was reduced 71% for the 18-mg group relative to placebo (difference 3.11±1.53 ml/min per 1.73 m 2  annualized over 1 year; 95% confidence interval, 0.10-6.13; nominal  P =0.043). Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
CONCLUSIONS


Although the trial did not meet its primary endpoint, exploratory post hoc analyses suggest that selonsertib may slow diabetic kidney disease progression.",2019,"Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
","['Patients with Diabetic Kidney Disease', 'adults with type 2 diabetes and treatment-refractory moderate-to-advanced diabetic kidney disease']","['Selonsertib', 'placebo']","['urine albumin-to-creatinine ratio', 'mean eGFR', 'eGFR decline', 'rate of eGFR decline', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",333.0,0.58165,"Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California; gchertow@stanford.edu.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas; and.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Kirby', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018121231']
1480,31498125,"Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study.","Previous studies have indicated that an active lifestyle is associated with better brain health and a longer life, compared to a more sedentary lifestyle. These studies, both on human and animal subjects, have typically focused on a single activity, usually physical exercise, but other activities have received an increasing interest. One proposed mechanism is that physical exercise increases levels of brain-derived neurotrophic factor (BDNF) in the brain. For the first time, the long-term effects on serum BDNF levels were compared in persons who engaged in either physical exercise training, cognitive training, or mindfulness practice during 5 weeks, and compared with an active control group. Two cohorts of healthy older individuals, one from the Boston area in the US and one from the Växjö area in Sweden, participated. A total of 146 participants were randomly assigned to one of the four groups. All interventions were structurally similar, using interactive, computer-based software that directed participants to carry out specified activities for 35 minutes/day, 5 days per week for 5 weeks. Blood samples were obtained at baseline and soon after the completion of the 5-week long intervention program, and serum BDNF levels were measured using a commercially available ELISA. Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase. These results strongly suggest that cognitive training can exert beneficial effects on brain health in an older adult population.",2019,"Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase.","['Healthy Older Adults', 'healthy older individuals, one from the Boston area in the US and one from the Växjö area in Sweden, participated', 'older adult population', 'A total of 146 participants']","['cognitive training', 'Physical Exercise, Cognitive Training, and Mindfulness Practice', 'physical exercise training, cognitive training']","['Serum BDNF Levels', 'serum BDNF levels', 'Blood samples', 'brain health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",146.0,0.0188457,"Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase.","[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Ledreux', 'Affiliation': 'Knoebel Institute for Healthy Aging, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Krister', 'Initials': 'K', 'LastName': 'Håkansson', 'Affiliation': 'Theme Aging, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Carlsson', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Mhretab', 'Initials': 'M', 'LastName': 'Kidane', 'Affiliation': 'Department of Computer Science and Media Technology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Columbo', 'Affiliation': 'Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Terjestam', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Tusch', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Winblad', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Daffner', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Granholm', 'Affiliation': 'Knoebel Institute for Healthy Aging, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Abdul Kadir H', 'Initials': 'AKH', 'LastName': 'Mohammed', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190756']
1481,29750251,"Effect of Aerobic Exercise Training and Essential Amino Acid Supplementation for 24 Weeks on Physical Function, Body Composition, and Muscle Metabolism in Healthy, Independent Older Adults: A Randomized Clinical Trial.","BACKGROUND


Essential amino acids (EAA) and aerobic exercise (AE) acutely and independently stimulate skeletal muscle protein anabolism in older adults.
OBJECTIVE


In this Phase 1, double-blind, placebo-controlled, randomized clinical trial, we determined if chronic EAA supplementation, AE training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis.
METHODS


We phone-screened 971, enrolled 109, and randomized 50 independent, low-active, nonfrail, and nondiabetic older adults (age 72 ± 1 years). We used a 2 × 2 factorial design. The interventions were: daily nutritional supplementation (15 g EAA or placebo) and physical activity (supervised AE training 3 days/week or monitored habitual activity) for 24 weeks. Muscle strength, physical function, body composition, and muscle protein synthesis were measured before and after the 24-week intervention.
RESULTS


Forty-five subjects completed the 24-week intervention. VO2peak and walking speed increased (p < .05) in both AE groups, irrespective of supplementation type, but muscle strength increased only in the EAA + AE group (p < .05). EAA supplementation acutely increased (p < .05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA + AE group after the intervention. Total and regional lean body mass did not change significantly with any intervention.
CONCLUSIONS


In nonfrail, independent, healthy older adults AE training increased walking speed and aerobic fitness, and, when combined with EAA supplementation, it also increased muscle strength and EAA-stimulated muscle protein synthesis. These increases occurred without improvements in muscle mass.",2019,"EAA supplementation acutely increased (p<0.05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA+AE group after the intervention.","['We phone screened 971, enrolled 109, and randomized 50 independent, low-active, non-frail, non-diabetic older adults (age 72±1 yrs', '45 subjects completed the 24-week intervention', 'Healthy', 'older adults', 'Independent Older Adults']","['Aerobic Exercise Training and Essential Amino Acid Supplementation', 'daily nutritional supplementation (15 g EAA or placebo) and physical activity (supervised AE training three days/week or monitored habitual activity', 'placebo', '\n\n\nEssential amino acids (EAA) and aerobic exercise (AE']","['Physical Function, Body Composition and Muscle Metabolism', 'Total and regional lean body mass', 'muscle strength', 'walking speed and aerobic fitness', 'EAA supplementation acutely increased (p<0.05) muscle protein synthesis', 'VO2peak and walking speed', 'Muscle strength, physical function, body composition, and muscle protein synthesis']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation (product)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}]",971.0,0.0724258,"EAA supplementation acutely increased (p<0.05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA+AE group after the intervention.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Markofski', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Kyle L', 'Initials': 'KL', 'LastName': 'Timmerman', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Fry', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Borack', 'Affiliation': 'Division of Rehabilitation Sciences, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'Division of Rehabilitation Sciences, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Randolph', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Blake B', 'Initials': 'BB', 'LastName': 'Rasmussen', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly109']
1482,29752009,"Effects of omega-3 polyunsaturated fatty acids on fibrosis, endothelial function and myocardial performance, in ischemic heart failure patients.","BACKGROUND & AIMS


Polyunsaturated fatty acids (PUFAs) may affect the cardiovascular system with a multiplicity of mechanisms. We assessed the effects of omega-3 PUFAs supplements on inflammation, fibrosis, left ventricle performance and endothelial function of ischemic heart failure (HF) patients.
METHODS


In this double-blind, placebo controlled, cross-over trial we enrolled 31 patients with ischemic HF, followed by a 6-week wash-out period. Omega-3 PUFAs (2 g daily, 8 weeks) were administered PO in the intervention arm. Left ventricle ejection fraction (EF), global longitudinal strain and the ratio E/e' (early ventricular filling to early mitral annulus velocities)were measured. Endothelial function was evaluated by flow mediated dilation and myocardial fibrosis by soluble ST2. High sensitive C Reactive protein (hsCRP) levels were measured as an inflammatory marker.
RESULTS


Treatment with omega-3 PUFA, compared to placebo, improved: left ventricle EF (percent increased by 4.7% vs 1.7%); global longitudinal strain (decreased by -10.6% vs -2.3%); the E/e' ratio (decreased by -9.47% vs -2.1%); ST2 levels (decreased by -4.53% vs -2.37%); flow mediated dilation (percent increased by 44% vs. 11% and hsCRP levels (decreased by -6.13% vs 4.35%) (p < 0.05 for all).
CONCLUSION


Short term treatment with omega-3 PUFAs in subjects with stable ischemic HF improved inflammatory and fibrotic status as well as endothelial function in parallel with systolic and diastolic performance of left ventricle. These findings provide further insights regarding the impact of omega-3 PUFAs administration on left ventricle performance indices, systemic inflammation and fibrosis biomarkers in patients with ischemic HF.",2019,"RESULTS


Treatment with omega-3 PUFA, compared to placebo, improved: left ventricle EF (percent increased by 4.7% vs 1.7%); global longitudinal strain (decreased by -10.6% vs -2.3%); the E/e' ratio (decreased by -9.47% vs -2.1%); ST2 levels (decreased by -4.53% vs -2.37%); flow mediated dilation (percent increased by 44% vs. 11% and hsCRP levels (decreased by -6.13% vs 4.35%) (p < 0.05 for all).
CONCLUSION


Short term treatment with omega-3 PUFAs in subjects with stable ischemic HF improved inflammatory and fibrotic status as well as endothelial function in parallel with systolic and diastolic performance of left ventricle.","['ischemic heart failure patients', '31 patients with ischemic HF, followed by a 6-week wash-out period', 'patients with ischemic HF']","['placebo', 'omega-3 PUFAs supplements', 'omega-3 PUFA', 'omega-3 PUFAs', 'Polyunsaturated fatty acids (PUFAs', 'omega-3 polyunsaturated fatty acids', 'Omega-3 PUFAs']","['global longitudinal strain', 'fibrosis, endothelial function and myocardial performance', 'ST2 levels', ' left ventricle EF', 'inflammatory and fibrotic status', 'left ventricle performance indices, systemic inflammation and fibrosis biomarkers', 'High sensitive C Reactive protein (hsCRP) levels', 'hsCRP levels', 'Endothelial function', 'inflammation, fibrosis, left ventricle performance and endothelial function', 'flow mediated dilation', ""Left ventricle ejection fraction (EF), global longitudinal strain and the ratio E/e' (early ventricular filling to early mitral annulus velocities)were""]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0225897', 'cui_str': 'Left Ventricle'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",31.0,0.1239,"RESULTS


Treatment with omega-3 PUFA, compared to placebo, improved: left ventricle EF (percent increased by 4.7% vs 1.7%); global longitudinal strain (decreased by -10.6% vs -2.3%); the E/e' ratio (decreased by -9.47% vs -2.1%); ST2 levels (decreased by -4.53% vs -2.37%); flow mediated dilation (percent increased by 44% vs. 11% and hsCRP levels (decreased by -6.13% vs 4.35%) (p < 0.05 for all).
CONCLUSION


Short term treatment with omega-3 PUFAs in subjects with stable ischemic HF improved inflammatory and fibrotic status as well as endothelial function in parallel with systolic and diastolic performance of left ventricle.","[{'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Oikonomou', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece. Electronic address: boikono@gmail.com.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Vogiatzi', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Karlis', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School and Harvard, Boston, MA, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chrysohoou', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Zografos', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lazaros', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsalamandris', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Mourouzis', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Georgiopoulos', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Toutouza', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': ""First Cardiology Clinic, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.04.017']
1483,30477346,"Comments on ""Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial"".",,2019,,['De Quervain Tenosynovitis'],[],[],"[{'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}]",[],[],,0.0176729,,"[{'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Abi-Rafeh', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Kazan', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thibaudeau', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada.'}]","Hand (New York, N.Y.)",['10.1177/1558944718813734']
1484,29987586,Evaluation of Health Belief Model-Based Intervention on Breast Cancer Screening Behaviors among Health Volunteers.,"Breast cancer is the most common cancer and the second leading cause of death among women. Regarding the lack of knowledge about the cause of breast cancer and considering the fact that all women are prone to this disease, training on methods of early diagnosis to reduce its complications is of great importance. Thus, this study aimed to determine the effect of education based on the health belief model on breast cancer screening behaviors in health volunteers of health centers in Isfahan. In this experimental study, 480 healthy volunteers were randomly divided into two groups: the case (n = 240) and control (n = 240). The training program was designed according to health belief model structures. Before the training interventional program, the Champion standard questionnaire and functional checklist were completed for both groups. A standard questionnaire was completed during three stages (before, immediately after, and 2 months after the training). The experimental group received the educational intervention during eight sessions, and the collected data was eventually analyzed using the SPSS statistical software version 16 with relevant statistical tests. Participation of all individuals in the present research was voluntary and with informed consent. The results showed that mean scores of knowledge, perceived susceptibility, severity, benefits, barriers, self-efficacy, and behavioral intention related to breast self-examination (BSE) and mammography in the intervention group significantly increased compared with those of the control group immediately after and 2 months after educational intervention. There was a significant difference between groups in BSE skill 2 months after the intervention, but there was no significant difference between the two groups in BSE behavior and mammography 2 months after the intervention. The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.",2019,The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.,"['Breast Cancer Screening Behaviors among Health Volunteers', '480 healthy volunteers', 'health volunteers of health centers in Isfahan']","['educational intervention', 'Health Belief Model-Based Intervention']","['BSE skill', 'mean scores of knowledge, perceived susceptibility, severity, benefits, barriers, self-efficacy, and behavioral intention related to breast self-examination (BSE) and mammography', 'efficiency and effectiveness']","[{'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0085105', 'cui_str': 'Breast Self-Examination'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",480.0,0.0117454,The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.,"[{'ForeName': 'Mohtasham', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz Nasiri', 'Initials': 'SN', 'LastName': 'Esfahani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Rakhshanderou', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa Hosseini', 'Initials': 'PH', 'LastName': 'Koukamari', 'Affiliation': 'School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Hosseinikoukamari.parisa@gmail.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1394-9']
1485,31367781,Surgical Notes: To Play or Not to Play.,"INTRODUCTION


Music is any sound that is perceived as pleasingly harmonious. The link between music and healthcare can be traced long back in the history of mankind. Thus, our study aimed at assessing the impact of different genre of music on the cognition functioning, memory and attention levels of the surgeons.
MATERIALS AND METHODS


It was a single-arm interventional trial assessing 45 surgeons from different specialities. Each participant was expected to do 5 sets of tasks, one set each for the 5 music tracks played. Each task set further contained 5 different types of tasks, namely trail marking, jigsaw puzzle, backward counting, comprehension and memory game using cards. The 5 music tracks included ambient OR noise, music of personal preference, western classical, heavy metal and pop music. Scores were assigned for each task and compared.
RESULTS


The total score for music of personal choice was much less (19.68) when compared to the other genre and that for pop was the highest (25.03). Memory card tests and backward counting (tests of short-term memory) were comparatively better with music of personal choice. However, trail marking (test of speed) and jigsaw puzzle and comprehension tests (tests of complex neurological functions) were least performed when music of personal choice was played.
CONCLUSION


Music of choice may help in short-term memory recall, but an over-familiarity with the music played can serve as a distractor thus affecting the speed and accuracy.",2019,The total score for music of personal choice was much less (19.68) when compared to the other genre and that for pop was the highest (25.03).,['45 surgeons from different specialities'],[],"['cognition functioning, memory and attention levels', 'total score for music of personal choice', 'ambient OR noise, music of personal preference, western classical, heavy metal and pop music', 'Memory card tests and backward counting (tests of short-term memory']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]",[],"[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0347988', 'cui_str': 'Metals, Heavy'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.0659038,The total score for music of personal choice was much less (19.68) when compared to the other genre and that for pop was the highest (25.03).,"[{'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Mitta', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India. niveditamitta@gmail.com.""}, {'ForeName': 'Vivekanandan', 'Initials': 'V', 'LastName': 'Jayakumar', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Dhanpal', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'Jeffrey Pradeep', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Pharmacology, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'Roshini Antony', 'Initials': 'RA', 'LastName': 'Prabhakaran', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Kannan', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Venugopal', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Subramanyam', 'Affiliation': ""Department of General Surgery, St. John's Medical College and Hospital, John Nagar, Bangalore, 560034, India.""}]",World journal of surgery,['10.1007/s00268-019-05090-z']
1486,29664672,Primary Care Physicians Can Comprehensively Manage Sleep Apnea Patients: A Non-inferiority Randomized Controlled Trial.,"RATIONALE


General practitioners play a passive role in obstructive sleep apnea (OSA) management. Simplification of the diagnosis and use of a semi-automatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages.
OBJECTIVE


To determine differences in effectiveness between primary healthcare area (PHA) and in-hospital specialized management protocols during six months of follow-up.
METHOD


A multicenter, non-inferiority, randomized, controlled trial with two open parallel arms and a cost-effectiveness analysis was performed in six tertiary hospitals in Spain. Sequentially screened patients with suspected OSA were randomized to PHA or in-hospital managements. The PHA arm received a portable monitor (PM) with automatic scoring and semi-automatic therapeutic decision-making. The in-hospital arm underwent polysomnography (PSG) and specialized therapeutic decision-making. Both arms received continuous positive airway pressure (CPAP) treatment or only sleep hygiene and dietary treatment. The primary outcome measure was the Epworth sleepiness scale (ESS). Secondary outcomes were the health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, CPAP adherence and within-trial costs.
RESULTS


In total, 307 patients were randomized and 303 were included in the intention-to-treat analysis. Based on the ESS, the PHA protocol was non-inferior to the in-hospital protocol. Secondary outcome variables were similar between protocols. The cost-effectiveness relationship favored the PHA arm, with a lower cost of 537.8€ per patient.
CONCLUSION


In-hospital management is not necessary for approximately half of patients with a low to high OSA suspicion. Given the clear economic advantage of outpatient management, this finding could change established clinical practice. Clinical trial registration available at www.clinicaltrials.gov, ID NCT02141165.",2018,"Simplification of the diagnosis and use of a semi-automatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages.
","['Sequentially screened patients with suspected OSA', 'Sleep Apnea Patients', 'General practitioners play a passive role in obstructive sleep apnea (OSA) management', '307 patients were randomized and 303 were included in the intention-to-treat analysis', 'six tertiary hospitals in Spain']","['polysomnography (PSG', 'portable monitor (PM) with automatic scoring and semi-automatic therapeutic decision-making', 'continuous positive airway pressure (CPAP) treatment or only sleep hygiene and dietary treatment']","['Epworth sleepiness scale (ESS', 'cost-effectiveness relationship', 'health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, CPAP adherence and within-trial costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",307.0,0.150682,"Simplification of the diagnosis and use of a semi-automatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages.
","[{'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'Hospital Virgen del Puerto, 161637, Plasencia, Extremadura, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'San Pedro de Alcántara Hospital and CIBER de Enfermedades Respiratorias (CIBERES), Pulmonology., Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Gómez-de-Terreros', 'Affiliation': 'San Pedro de Alcántara Hospital and CIBER of Respiratory Diseases (CIBERES), Cáceres, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Carmona-Bernal', 'Affiliation': 'Hospital Universitario Virgen del Rocio, 16885, Sevilla, Andalucía, Spain.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Asensio-Cruz', 'Affiliation': 'Hospital Universitario Virgen del Rocio, 16885, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cabello', 'Affiliation': 'Hospital Universitario Marques de Valdecilla, 16516, Santander, Cantabria, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Martínez-Martínez', 'Affiliation': 'Valdecillas Hospital, Santander, Spain.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Egea', 'Affiliation': 'Sleep Unit, Respiratory Department, Alava University Hospital IRB and CIBER de Enfermedades Respiratorias (CIBERES), Vitoria, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax', 'Affiliation': 'University Hospital Burgos and CIBER de Enfermedades Respiratorias (CIBERES), Burgos, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbe', 'Affiliation': 'IRB Lleida, NEUMOLOGIA, Lleida, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Universidad de Extremadura, 16759, Caceres, Extremadura, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'San Pedro de Alcantara Hospital and CIBER of Respiratory Diseases (CIBERES), ISCIII, Cáceres, Spain ; fmasa@separ.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Galo', 'Initials': 'G', 'LastName': 'Fernández-Zapata', 'Affiliation': ''}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Sánchez-Armengol', 'Affiliation': ''}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Cantalejo', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ocon', 'Affiliation': ''}, {'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Álvarez-Ruiz de Larrinaga', 'Affiliation': ''}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Azpiazu', 'Affiliation': ''}, {'ForeName': 'M. Luz', 'Initials': 'ML', 'LastName': 'Alonso-Alvarez', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Tobajas', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rubio', 'Affiliation': ''}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Gómez-Espárrago', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lebrero-Ferreiro', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Hermosin-Bono', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Juan-Armas', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Crespo-Fidalgo', 'Affiliation': ''}, {'ForeName': 'M. Hermosa', 'Initials': 'MH', 'LastName': 'De-la-Llama', 'Affiliation': ''}, {'ForeName': 'M. Elena', 'Initials': 'ME', 'LastName': 'Vega-Dominguez', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201710-2061OC']
1487,29688760,"Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial.","RATIONALE


Cystic fibrosis (CF) is characterized by dietary antioxidant deficiencies, which may contribute to an oxidant-antioxidant imbalance and oxidative stress.
OBJECTIVES


Evaluate the effects of an oral antioxidant-enriched multivitamin supplement on antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes.
METHODS


In this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic-insufficient subjects with CF 10 years of age and older with an FEV 1  between 40% and 100% predicted were randomized to 16 weeks of an antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment. Endpoints included systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety, and tolerability.
MEASUREMENTS AND MAIN RESULTS


Change in sputum myeloperoxidase concentration over 16 weeks, the primary efficacy endpoint, was not significantly different between the treated and control groups. Systemic antioxidant (β-carotene, coenzyme Q10, γ-tocopherol, and lutein) concentrations significantly increased in the antioxidant-treated group (P < 0.001 for each), whereas circulating calprotectin and myeloperoxidase decreased in the treated group compared with the control group at Week 4. The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio, 0.50; P = 0.04). Lung function and growth endpoints did not differ between groups. Adverse events and tolerability were similar between groups.
CONCLUSIONS


Antioxidant supplementation was safe and well tolerated, resulting in increased systemic antioxidant concentrations and modest reductions in systemic inflammation after 4 weeks. Antioxidant treatment was also associated with a lower risk of first pulmonary exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT01859390).",2018,"The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio, 0.50; P = 0.04).","['Cystic fibrosis (CF', '73 pancreatic-insufficient subjects with CF 10 years of age and older with an FEV 1  between 40% and 100% predicted', 'Cystic Fibrosis']","['oral antioxidant-enriched multivitamin supplement', 'Antioxidant supplementation', 'antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment', 'Antioxidant-enriched Multivitamin']","['safe and well tolerated', 'sputum myeloperoxidase concentration', 'systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety, and tolerability', 'Systemic antioxidant (β-carotene, coenzyme Q10, γ-tocopherol, and lutein) concentrations', 'lower risk of first pulmonary exacerbation requiring antibiotics', 'circulating calprotectin and myeloperoxidase', 'Adverse events and tolerability', 'systemic inflammation', 'antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes', 'lower risk of first pulmonary exacerbation', 'Lung function and growth endpoints', 'systemic antioxidant concentrations']","[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",73.0,0.584893,"The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio, 0.50; P = 0.04).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Sagel', 'Affiliation': ""1 Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Umer', 'Initials': 'U', 'LastName': 'Khan', 'Affiliation': ""2 Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Raksha', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': '3 Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Graff', 'Affiliation': '4 Department of Pediatrics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Cori L', 'Initials': 'CL', 'LastName': 'Daines', 'Affiliation': '5 Department of Pediatrics, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Dunitz', 'Affiliation': '6 Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Drucy', 'Initials': 'D', 'LastName': 'Borowitz', 'Affiliation': '7 Department of Pediatrics, Jacobs School of Medicine, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Orenstein', 'Affiliation': ""8 Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdulhamid', 'Affiliation': ""9 Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Noe', 'Affiliation': ""10 Department of Pediatrics, Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Clancy', 'Affiliation': ""11 Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Slovis', 'Affiliation': '12 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rock', 'Affiliation': '13 Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'McCoy', 'Affiliation': ""14 Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Strausbaugh', 'Affiliation': ""15 Department of Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Floyd R', 'Initials': 'FR', 'LastName': 'Livingston', 'Affiliation': ""16 Department of Pediatrics, Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'Konstantinos A', 'Initials': 'KA', 'LastName': 'Papas', 'Affiliation': '17 Callion Pharma, Jonesborough, Tennessee and.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Shaffer', 'Affiliation': '18 Department of Statistics, University of Washington, Seattle, Washington.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201801-0105OC']
1488,29513088,"Ingestion of coffee polyphenols suppresses deterioration of skin barrier function after barrier disruption, concomitant with the modulation of autonomic nervous system activity in healthy subjects.","The aim of this study was to evaluate the effect of consumption of coffee polyphenols (CPPs) on the autonomic nervous system activity and decreased skin barrier function caused by sodium dodecyl sulfate (SDS) treatment. In this single-blind, placebo-controlled study, ten healthy male subjects consumed either a beverage containing CPPs or a placebo beverage for four weeks. CPPs significantly suppressed the deterioration in skin barrier function and skin moisture content induced by SDS treatment after the third week. Furthermore, in the heart rate variability analysis, CPPs significantly produced an increase in parasympathetic nervous activity, and a decrease in sympathetic nervous activity after the four weeks of beverage consumption. These results suggest that CPPs might influence the regulation of the autonomic nervous system and contribute to the suppressive effect on deterioration of skin barrier function.",2018,"Furthermore, in the heart rate variability analysis, CPPs significantly produced an increase in parasympathetic nervous activity, and a decrease in sympathetic nervous activity after the four weeks of beverage consumption.","['healthy subjects', 'ten healthy male subjects']","['placebo', 'sodium dodecyl sulfate (SDS', 'coffee polyphenols (CPPs', 'coffee polyphenols', 'beverage containing CPPs or a placebo']","['deterioration in skin barrier function and skin moisture content', 'skin barrier function', 'parasympathetic nervous activity', 'sympathetic nervous activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037506', 'cui_str': 'sodium lauryl sulfate'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",10.0,0.0196675,"Furthermore, in the heart rate variability analysis, CPPs significantly produced an increase in parasympathetic nervous activity, and a decrease in sympathetic nervous activity after the four weeks of beverage consumption.","[{'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Kagawa', 'Affiliation': 'Biological Science Research, Kao Corporation, Tochigi, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Fujii', 'Affiliation': 'Biological Science Research, Kao Corporation, Tochigi, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Ohtsuka', 'Affiliation': 'Biological Science Research, Kao Corporation, Tochigi, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Murase', 'Affiliation': 'Biological Science Research, Kao Corporation, Tochigi, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2018.1445520']
1489,29702032,"Effect of Midmorning Puree Snacks on Subjective Appetite, Food Intake, and Glycemic and Insulin Responses in Healthy Adults.","Objective : Dietary pattern changes, as a part of a healthy lifestyle, may improve weight management. The objective of this study was to examine the effect of midmorning puree snacks varying in macronutrient composition and energy content on subjective appetite, food intake, and glycemic and insulin responses in healthy adults. Method : In a randomized, repeated measures crossover design, 6 treatments (snack skipping and purees: control [186 kcal], maltodextrin [272 kcal], whey protein [201 kcal], oat [276 kcal], and coconut oil [276 kcal]) were administered to 23 normal weight adults (n = 14 males, n = 9 females). Subjective appetite, blood glucose, and insulin responses were measured at regular intervals for 2 hours immediately followed by an  ad libitum  pizza lunch.  In vitro  digestion experiments were conducted to corroborate results of the human trial. Results : Compared to snack skipping, all snack treatments similarly reduced subjective average appetite (net area under the curve), but only oat (p < 0.032) and coconut oil (p < 0.031) purees significantly decreased test meal food intake. However, caloric compensation did not differ among snack treatments (p < 0.73). Both blood glucose (incremental area under the curve [iAUC]; p < 0.0001) and serum insulin (iAUC; p < 0.0001) were affected by treatment. A positive correlation was found between blood glucose iAUC and  in vitro  glucose release (r = 0.993, p < 0.0001). The release of free fatty acids (FFAs) was sustained, and oats were difficult to disintegrate during  in vitro  digestion. Conclusions : Compared with snack skipping, coconut oil and oat puree snacks suppressed short-term food intake, which was likely due to the sustained release of FFA and slowly digestible oats, respectively. Our  in vitro  digestion model predicted the relative differences in the glycemic response  in vivo .",2018,Both blood glucose (incremental area under the curve [iAUC]; p < 0.0001) and serum insulin (iAUC; p < 0.0001) were affected by treatment.,"['23 normal weight adults (n = 14 males, n = 9 females', 'healthy adults', 'Healthy Adults']","['snack skipping, coconut oil and oat puree snacks', 'Midmorning Puree Snacks', 'midmorning puree snacks', '6 treatments (snack skipping and purees: control [186\xa0kcal], maltodextrin [272\xa0kcal], whey protein [201\xa0kcal], oat [276\xa0kcal], and coconut oil [276\xa0kcal']","['release of free fatty acids (FFAs', 'blood glucose iAUC and in vitro glucose release', 'blood glucose', 'Subjective Appetite, Food Intake, and Glycemic and Insulin Responses', 'subjective average appetite', 'caloric compensation', 'subjective appetite, food intake, and glycemic and insulin responses', 'Subjective appetite, blood glucose, and insulin responses', 'glycemic response']","[{'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",,0.0273343,Both blood glucose (incremental area under the curve [iAUC]; p < 0.0001) and serum insulin (iAUC; p < 0.0001) were affected by treatment.,"[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Chemistry and Biology, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology & Health Studies, University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hayden', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Crozier', 'Affiliation': 'The Hershey Company, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Mongia', 'Affiliation': 'The Hershey Company, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry and Biology, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1457457']
1490,29702041,Influence of the C677T Polymorphism of the  MTHFR  Gene on Oxidative Stress in Women With Overweight or Obesity: Response to a Dietary Folate Intervention.,"The C677T polymorphism of the methylenetetrahydrofolate reductase gene ( MTHFR ) is related to folate metabolism and can alter the levels of biochemical markers. Objective : Investigate the influence of the  MTHFR  C677T polymorphism on the effects of a dietary folate intervention on oxidative stress in women with overweight or obesity. Methods : Forty-eight adult women with overweight or obesity were subjected to a 24-hour dietary recall, anthropometric measurements, biochemical analysis, and genotyping of the  MTHFR  C677T polymorphism. They were allocated by convenience sampling to 2 groups, which received 300 g of folate-rich vegetables containing 191 µg/d (Group 1) ( n  = 24) or 95 µg/d (Group 2) ( n  = 24) of folate for 8 weeks. Results : The dietary intervention increased the serum folic acid levels in the 2 analyzed groups. The intervention with 191 µg/d of folate led to relevant results in terms of homocysteine levels ( p  = 0.0005) and total antioxidant capacity ( p  = 0.0261); the effect was larger among carriers of the TT genotype. Conclusions : The study demonstrated the beneficial effect of folate intake in terms of a TAC elevation for the CC and TT genotypes of the  MTHFR  C677T polymorphism, an increase in folic acid levels for all genotypes, and a reduction in the Hcy levels for the TT genotype in response to an intervention consisting of an intake of 191 µg/d of folate supplied by vegetables.",2018,"The C677T polymorphism of the methylenetetrahydrofolate reductase gene (MTHFR) is related to folate metabolism and can alter the levels of biochemical markers.
","['women with overweight or obesity', 'Women With Overweight or Obesity', 'Forty-eight adult women with overweight or obesity']","['Dietary Folate Intervention', '300\xa0g of folate-rich vegetables', 'dietary folate intervention', 'C677T Polymorphism of the MTHFR Gene', 'MTHFR C677T polymorphism']","['oxidative stress', 'Oxidative Stress', 'folic acid levels', 'serum folic acid levels', 'homocysteine levels', 'total antioxidant capacity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0427412', 'cui_str': 'Folic acid level - finding'}, {'cui': 'C0202020', 'cui_str': 'Serum folate measurement, serum'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",48.0,0.0537011,"The C677T polymorphism of the methylenetetrahydrofolate reductase gene (MTHFR) is related to folate metabolism and can alter the levels of biochemical markers.
","[{'ForeName': 'Marina Ramalho', 'Initials': 'MR', 'LastName': 'Ribeiro', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Raquel Patrícia Ataíde', 'Initials': 'RPA', 'LastName': 'Lima', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Jéssica Vanessa de Carvalho', 'Initials': 'JVC', 'LastName': 'Lisboa', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Thamires Ribeiro', 'Initials': 'TR', 'LastName': 'Chaves', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Rafaella Cristhine Pordeus', 'Initials': 'RCP', 'LastName': 'Luna', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Rayner Anderson Ferreira', 'Initials': 'RAF', 'LastName': 'do Nascimento', 'Affiliation': 'Graduate Program in Molecular and Human Biology, Center of Exact and Natural Sciences (Centro de Ciências Exatas e da Natureza-CCEN), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Graduate Program in Nutrition Sciences, (Centro de Ciências da Saúde-CCS), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Darlene Camati', 'Initials': 'DC', 'LastName': 'Persuhn', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Sérgio da Silva', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Maria da Conceição Rodrigues', 'Initials': 'MDCR', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Flávia Emília Leite de Lima', 'Initials': 'FELL', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Roberto Teixeira', 'Initials': 'RT', 'LastName': 'Lima', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Alcides', 'Initials': 'A', 'LastName': 'da Silva Diniz', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Alessio Tony Cavalcanti', 'Initials': 'ATC', 'LastName': 'de Almeida', 'Affiliation': 'Department of Economics, Center of Applied Social Sciences (Centro de Ciências Sociais Aplicadas-CCSA), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Ronei Marcos', 'Initials': 'RM', 'LastName': 'de Moraes', 'Affiliation': 'Graduate Program in Health Decision Models, Center of Exact and Natural Sciences (Centro de Ciências Exatas e da Natureza-CCEN), Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Eliseu', 'Initials': 'E', 'LastName': 'Verly Junior', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro (Universidade Estadual do Rio de Janeiro-UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria José de Carvalho', 'Initials': 'MJC', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Federal University of Paraiba (Universidade Federal da Paraíba-UFPB), João Pessoa, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1460224']
1491,31377171,The influence of coping skills training and family health education on self-esteem among adolescents in substance abuse prevention.,"OBJECTIVE


Substance abuse is one of the most serious problems in Indonesia and is highly prevalent among adolescents. Therefore, psychotherapy is needed in preventing substance abuse for adolescents. This study aims to analyze the influence of coping skills training and family health education on self-esteem in a sample of 87 young people.
METHOD


The sample was divided into two groups using simple random sampling. ANOVA was used to determine differences between the control group and those receiving coping skills training and family health education.
RESULTS


Self-esteem improved significantly in the group that received the experimental training (F(1.85)=44.70, p<0.001). Some practical implications can be deduced for psychiatric nurses to implemented coping skill training and family health education as a standard treatment in substance abuse prevention among adolescents.",2019,"RESULTS


Self-esteem improved significantly in the group that received the experimental training (F(1.85)=44.70, p<0.001).","['adolescents in substance abuse prevention', '87 young people']","['coping skills training and family health education', 'psychotherapy']","['Self-esteem', 'self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1171221', 'cui_str': 'Substance abuse prevention'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0729375', 'cui_str': 'Coping skills training (procedure)'}, {'cui': 'C0600220', 'cui_str': 'Family Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",87.0,0.0251689,"RESULTS


Self-esteem improved significantly in the group that received the experimental training (F(1.85)=44.70, p<0.001).","[{'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Sukamti', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Budi Anna', 'Initials': 'BA', 'LastName': 'Keliat', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: ba_keliat@ui.ac.id.'}, {'ForeName': 'Ice Yulia', 'Initials': 'IY', 'LastName': 'Wardani', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.081']
1492,29602791,Endogenous Glucose Production and Hormonal Changes in Response to Canagliflozin and Liraglutide Combination Therapy.,"The decrement in plasma glucose concentration with SGLT2 inhibitors (SGLT2i) is blunted by a rise in endogenous glucose production (EGP). We investigated the ability of incretin treatment to offset the EGP increase. Subjects with type 2 diabetes ( n  = 36) were randomized to  1 ) canagliflozin (CANA),  2 ) liraglutide (LIRA), or  3 ) CANA plus LIRA (CANA/LIRA). EGP was measured with [3- 3 H]glucose with or without drugs for 360 min. In the pretreatment studies, EGP was comparable and decreased (2.2 ± 0.1 to 1.7 ± 0.2 mg/kg ⋅ min) during a 300- to 360-min period ( P  < 0.01). The decrement in EGP was attenuated with CANA (2.1 ± 0.1 to 1.9 ± 0.1 mg/kg ⋅ min) and CANA/LIRA (2.2 ± 0.1 to 2.0 ± 0.1 mg/kg ⋅ min), whereas with LIRA it was the same (2.4 ± 0.2 to 1.8 ± 0.2 mg/kg ⋅ min) (all  P  < 0.05 vs. baseline). After CANA, the fasting plasma insulin concentration decreased (18 ± 2 to 12 ± 2 μU/mL,  P  < 0.05), while it remained unchanged in LIRA (18 ± 2 vs. 16 ± 2 μU/mL) and CANA/LIRA (17 ± 1 vs. 15 ± 2 μU/mL). Mean plasma glucagon did not change during the pretreatment studies from 0 to 360 min, while it increased with CANA (69 ± 3 to 78 ± 2 pg/mL,  P  < 0.05), decreased with LIRA (93 ± 6 to 80 ± 6 pg/mL,  P  < 0.05), and did not change in CANA/LIRA. LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP. Factors other than insulin and glucagon contribute to the stimulation of EGP after CANA-induced glucosuria.",2018,LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP.,['Subjects with type 2 diabetes ( n  = 36'],"['LIRA', 'CANA plus LIRA (CANA/LIRA', 'canagliflozin (CANA),  2 ) liraglutide (LIRA), or  3 ']","['fasting plasma insulin concentration', 'glucagon rise', 'EGP', 'plasma glucose concentration', 'Mean plasma glucagon']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}]",36.0,0.0207609,LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}]",Diabetes,['10.2337/db17-1278']
1493,31635952,"Effectiveness of a chronic cough management algorithm at the transitional stage from acute to chronic cough in children: a multicenter, nested, single-blind, randomised controlled trial.","BACKGROUND


Chronic (lasting at least 4 weeks) cough in children is an important cause of morbidity. An algorithmic approach to the management of coughs in children evaluated in observational studies and a randomised controlled trial (RCT) enrolled children referred with median cough duration of 16 weeks to specialist centres. We investigated whether applying an evidence-based cough management algorithm in non-specialist settings earlier, once cough persisted for more than 4 weeks, improved cough resolution compared with usual care.
METHODS


We undertook a multicentre, single-blind RCT nested within a prospective cohort study of children (<15 years) in Australia presenting to three primary care or three hospital emergency departments with an acute respiratory illness with cough. Children were excluded if they had a known diagnosis of an underlying chronic medical condition (excluding asthma) or had an immunosuppressive illness or were taking immunomodulating drugs for more than 2 weeks in the preceding 30 days, or had severe symptoms requiring inpatient hospitalisation. Children were followed up for 8 weeks; those with a persistent cough at day 28 were randomly assigned to the cough management algorithm or to usual care. Randomisation was stratified by reason for presentation, study site, and cough duration (4 weeks to <6 weeks vs ≥6 weeks) using computer-generated permuted blocks (block size of four) with a 1:1 allocation. The primary outcome was the proportion of children with cough resolution at day 56 (defined as resolved if the child did not cough for at least 3 days and nights since day 28 or a more than 75% reduction in their average day and night cough score). Absolute risk differences (RD absolute ) were calculated by modified intention-to-treat analysis (ITT). This trial is registered with the Australia New Zealand Clinical Trials Registry, ACTRN12615000132549.
FINDINGS


Between July 7, 2015, and Oct 31, 2018, 1018 children were screened, 509 were enrolled in the cohort study, and of 115 children in the ITT analysis, 57 were randomly assigned to the intervention group and 58 to the control group. Children had a median age of 1·6 years (IQR 1·0-4·5); 45 (39%) of 115 were Indigenous, and 59 (51%) were boys. By day 56, 33 (58%) of 57 children in the intervention group achieved cough resolution compared with 23 (40%) 58 in the control group; cough resolution was unknown in 12 (21%) of 57 children receiving the intervention and in 13 (22%) of 58 receiving the control. The RD absolute  assuming children with an unknown cough outcome were still coughing at day 56 was 18·3% (95% CI 0·3-36·2); the number needed-to-treat for benefit was five (95% CI 3-364); the adjusted odds ratio was 1·5 (95% CI 1·3-1·6), favouring the intervention group.
INTERPRETATION


This study suggests an evidence-based cough management algorithm improves cough resolution in community-based children in the early phases of chronic cough. However, larger studies to confirm these findings in primary care are required.
FUNDING


National Health and Medical Research Council.",2019,five (95% CI 3-364); the adjusted odds ratio was 1·5,"['community-based children in the early phases of chronic cough', 'Between July 7, 2015, and Oct 31, 2018, 1018 children were screened, 509 were enrolled in the cohort study, and of 115 children in the ITT analysis, 57 were randomly assigned to the intervention group and 58 to the control group', 'transitional stage from acute to chronic cough in children', 'Children were excluded if they had a known diagnosis of an underlying chronic medical condition (excluding asthma) or had an immunosuppressive illness or were taking immunomodulating drugs for more than 2 weeks in the preceding 30 days, or had severe symptoms requiring inpatient hospitalisation', 'children (<15 years) in Australia presenting to three primary care or three hospital emergency departments with an acute respiratory illness with cough', 'children referred with median cough duration of 16 weeks to specialist centres', 'Children were followed up for 8 weeks; those with a persistent cough at day 28', 'Children had a median age of 1·6 years (IQR 1·0-4·5); 45 (39%) of 115 were Indigenous, and 59 (51%) were boys']","['cough management algorithm or to usual care', 'chronic cough management algorithm']","['still coughing', 'cough resolution', 'Absolute risk differences (RD absolute ', 'night cough score', 'proportion of children with cough resolution']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0562483', 'cui_str': 'Persistent cough (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0002045'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",1018.0,0.221586,five (95% CI 3-364); the adjusted odds ratio was 1·5,"[{'ForeName': 'Kerry-Ann F', 'Initials': 'KF', 'LastName': ""O'Grady"", 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia. Electronic address: kerryann.ogrady@qut.edu.au.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Grimwood', 'Affiliation': 'School of Medicine, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; Departments of Infectious Diseases and Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Central Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Sheree', 'Initials': 'S', 'LastName': 'Rablin', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Lovie-Toon', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kaus', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buntain', 'Affiliation': ""Wesley Medical Centre, Auchenflower, QLD, Australia; Department of Respiratory Medicine, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Adsett', 'Affiliation': '78 Margaret Street, Toowoomba, QLD, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'The Toowoomba Hospital, Toowoomba, QLD, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Caboolture Hospital, Caboolture, QLD, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Caboolture Community Medical Centre, Caboolture, QLD, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Toombs', 'Affiliation': 'UQ Rural Clinical School, University of Queensland, Toowoomba, QLD, Australia.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia; Menzies School of Health Research, Charles Darwin University, Darwin Northern Territory, Australia; Department of Respiratory Medicine, QLD Children's Hospital, South Brisbane, QLD, Australia.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30327-X']
1494,29509592,Impact of Trabectedin Interruption and Subsequent Rechallenge on Progression in Patients With Advanced Soft Tissue Sarcoma: Long-term Follow-up of the T-DIS trial.,"OBJECTIVE


To assess the impact of trabectedin rechallenge.
PATIENTS AND METHODS


In the T-DIS trial (NCT0130309), after the 6 initial cycles of trabectedin, patients who were free from progressive disease (PD) were randomly assigned either to continuous treatment with trabectedin (C arm) or therapy interruption (I arm). Patients randomized in the interruption arm were allowed to restart trabectedin in case of PD. Herein we report an update of the impact of trabectedin discontinuation after subsequent rechallenge.
RESULTS


From February 2011 to March 2013, 27 and 26 nonprogressive patients were randomized to C and I arm, respectively. Twenty-two of 26 patients in I arm and 25 of 27 patients in C arm received 7 cycles and more. After randomization, the median number of cycles was similar in both arms (C arm: 5 cycles [range, 1 to 34]; I arm: 6 cycles [range, 1 to 48], P=0.96). After a median follow-up from randomization of 35.3 months, continuous treatment with trabectedin was associated with a significant improvement in progression-free survival compared with the rechallenge arm (5.3 vs. 3.5 mo, P=0.019). The observed difference in median overall survival from the seventh cycle did not meet the level of significance (26.0 vs. 14.9 mo, P=0.14). The safety profile was similar in both arms. Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
CONCLUSIONS


We have demonstrated that trabectedin retains its activity when patients are rechallenged on progression after a treatment break.",2018,"Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
","['27 and 26 nonprogressive patients', 'Patients With Advanced Soft Tissue Sarcoma', 'patients who were free from progressive disease (PD']","['continuous treatment with trabectedin (C arm) or therapy interruption', 'Trabectedin Interruption and Subsequent Rechallenge']","['Mean time spent without symptoms and toxicity (Q-TWIST', 'median number of cycles', 'progression-free survival', 'safety profile', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.255558,"Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
","[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Kotecki', 'Affiliation': 'Medical Oncology Department.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Medical Oncology Department, Villejuif.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Tresch-Bruneel', 'Affiliation': 'Methodology and Biostatistics Unit.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Medical Oncology Department, Centre Léon Bérard, Lyon.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Medical Oncology, Institut Claudius Regaud, Cedex.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': 'Medical Oncology Department, Institut Paoli Calmette, Marseille, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': 'Methodology and Biostatistics Unit.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mir', 'Affiliation': 'Medical Oncology Department, Villejuif.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'Medical Oncology Department, Villejuif.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Decoupigny', 'Affiliation': 'Clinical Research Unit, Centre Oscar Lambret.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Clisant', 'Affiliation': 'Clinical Research Unit, Centre Oscar Lambret.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Medical Oncology Department, Centre Léon Bérard, Lyon.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Medical Oncology Department.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000430']
1495,29716419,Lecture-based versus problem-based learning in ethics education among nursing students.,"BACKGROUND


Moral reasoning is a vital skill in the nursing profession. Teaching moral reasoning to students is necessary toward promoting nursing ethics.
OBJECTIVES


The aim of this study was to compare the effectiveness of problem-based learning and lecture-based methods in ethics education in improving (1) moral decision-making, (2) moral reasoning, (3) moral development, and (4) practical reasoning among nursing students.
RESEARCH DESIGN


This is a repeated measurement quasi-experimental study.
PARTICIPANTS AND RESEARCH CONTEXT


The participants were nursing students in a University of Medical Sciences in west of Iran who were randomly assigned to the lecture-based (n = 33) or the problem-based learning (n = 33) groups. The subjects were provided nursing ethics education in four 2-h sessions. The educational content was similar, but the training methods were different. The subjects completed the Nursing Dilemma Test before, immediately after, and 1 month after the training. The data were analyzed and compared using the SPSS-16 software.
ETHICAL CONSIDERATIONS


The program was explained to the students, all of whom signed an informed consent form at the baseline.
FINDINGS


The two groups were similar in personal characteristics (p > 0.05). A significant improvement was observed in the mean scores on moral development in the problem-based learning compared with the lecture-based group (p < 0.05). Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05). The mean scores on moral decision-making, practical considerations, and familiarity with dilemmas were relatively similar for the two groups.
CONCLUSION


The use of the problem-based learning method in ethics education enhances moral development among nursing students. However, further studies are needed to determine whether such method improves moral decision-making, moral reasoning, practical considerations, and familiarity with the ethical issues among nursing students.",2019,"Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05).","['participants were nursing students in a University of Medical Sciences in west of Iran who were randomly assigned to the lecture-based (n = 33) or the', 'nursing students', 'Participants and research context']","['problem-based learning and lecture-based methods in ethics education', 'Lecture-based versus problem-based learning', 'problem-based learning']","['moral reasoning', 'mean scores on moral decision-making, practical considerations, and familiarity with dilemmas', 'mean scores on moral development']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}]","[{'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0026532', 'cui_str': 'Morals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0026527', 'cui_str': 'Moral Development'}]",,0.0192198,"Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05).","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'Associate Profssor, Mother and Child Care Research Center, Dept. of Medical Surgical Nursing, School of Nursing and Midwifery School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyede Nayereh', 'Initials': 'SN', 'LastName': 'Falahan', 'Affiliation': 'Instructor, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Amini', 'Affiliation': 'Faculty Member, Chronic Diseases (Home care) Research Center, Dept. of Community Health Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Farahanchi', 'Affiliation': 'Assistant Professor, Department of Forensic Medicine and Professional Ethics, Medical School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soltanian', 'Affiliation': 'Associate Professor, Modeling of Noncommunicable Diseases Research Center, Dept. of Biostatistics, School of Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Nursing ethics,['10.1177/0969733018767246']
1496,29624123,The Mediating Role of Coping Self-Efficacy in Hope Box Use and Suicidal Ideation Severity.,"In this study, we examined the indirect effect of the Virtual Hope Box (VHB) smartphone application on suicidal ideation, mediated through coping self-efficacy. A total of 117 veterans with suicidal ideation completed measures on coping self-efficacy and suicidal ideation at baseline and weeks 3, 6, and 12. Participants were randomly assigned to either the VHB or enhanced treatment as usual (eTAU) condition. Parallel process growth curve modeling (-0.20 [95% CI = -0.44, 0.00]) and auto-regressive modeling (-0.12 [95% CI = -0.35, -0.01]) revealed that a higher rate of change in coping self-efficacy in the VHB group was associated with a decrease in suicidal ideation severity, as compared to the eTAU group. Findings suggest that coping self-efficacy may be one mechanism by which the VHB operates to help reduce suicidal ideation. More broadly, the role of coping self-efficacy in reducing suicidal ideation is worthy of future study.",2019,"Parallel process growth curve modeling (-0.20 [95% CI = -0.44, 0.00]) and auto-regressive modeling (-0.12",['117 veterans with suicidal ideation'],"['Virtual Hope Box (VHB) smartphone application', 'VHB or enhanced treatment as usual (eTAU) condition']","['coping self-efficacy', 'coping self-efficacy and suicidal ideation', 'suicidal ideation', 'suicidal ideation severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",117.0,0.0258754,"Parallel process growth curve modeling (-0.20 [95% CI = -0.44, 0.00]) and auto-regressive modeling (-0.12","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Denneson', 'Affiliation': ''}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Smolenski', 'Affiliation': ''}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Dobscha', 'Affiliation': ''}, {'ForeName': 'Nigel E', 'Initials': 'NE', 'LastName': 'Bush', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2018.1456383']
1497,24489418,Rejoinder to comments on Evaluation of Viable Dynamic Treatment Regimes in a Sequentially Randomized Trial of Advanced Prostate Cancer.,,2012,,['Advanced Prostate Cancer'],[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],[],,0.0191607,,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rotnitzky', 'Affiliation': ''}, {'ForeName': 'Xihong', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Randall E', 'Initials': 'RE', 'LastName': 'Millikan', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}]",Journal of the American Statistical Association,[]
1498,29428925,Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer for Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation.,"Context


Global morbidity from chronic obstructive pulmonary disease (COPD) is high worldwide. Diaphragm pacing (DP) can maintain the natural, negative pressure breathing of COPD patients with diaphragmatic muscle dysfunction. The YiqiDitanTongfu (YDTF) decoction has been used clinically with COPD patients to help them to wean from mechanical ventilation, with their ventilation functions being improved and the success rate of weaning being largely increased.
Objective


The study intended to investigate the combined therapeutic effects of external DP and the YDTF decoction for COPD patients who have had difficulty weaning from mechanical ventilation.
Design


This study was a retrospective cohort study.
Setting


The study occurred at the Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China).
Participants


Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage.
Intervention


The participants were randomly divided into 3 groups: (1) traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group). All treatments occurred for 12 d.
Outcome Measures


Relevant outcomes were measured and compared at baseline and postintervention, including the rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation.
Results


The patients treated with the DP plus the YDTF decoction were more successful in weaning from mechanical ventilation than those treated with DP. Of the patients with COPD + type 1 respiratory failure, 86.67% succeeded vs 70.00% of the DP patients. Of patients with COPD + type 2 respiratory failure, 87.88% succeeded vs 79.41% of the DP patients.
Conclusion


The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.",2020,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","['Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation', 'Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China', 'Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage', 'Participants •', 'COPD patients who have had difficulty weaning from mechanical ventilation', 'COPD patients with diaphragmatic muscle dysfunction', 'chronic obstructive pulmonary disease (COPD']","['Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer', 'Diaphragm pacing (DP', 'YDTF decoction', 'external DP and the YDTF decoction', 'traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group', 'YiqiDitanTongfu (YDTF) decoction']","['Global morbidity', 'rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}, {'cui': 'C0398353', 'cui_str': 'Type II respiratory failure'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C1301400', 'cui_str': 'Diaphragm pacing'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0232022', 'cui_str': 'Maximum expiratory pressure (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",101.0,0.0352537,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Quansheng', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Heling', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Xianlei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
1499,31553108,Recontacting patients for multigene panel testing in hereditary cancer: Efficacy and insights.,"In hereditary cancer, multigene panel testing is currently replacing older single-gene approaches. Patients whose tests were previously uninformative could benefit from updated testing. Research suggests that patients desire to be recontacted about updated genetic testing, but few studies have tested the efficacy of recontact efforts. This study investigated the outcomes of a recontact effort in a hereditary cancer clinic and explored the impact of four different recontact letters, randomized in a 2X2 factorial design. Patients who had negative genetic testing for single genes or conditions were mailed letters inviting them to schedule an appointment to discuss updated testing. Patients were randomized to receive one of four letters and each letter emphasized different implications of updated multigene genetic testing: (a) personal medical management implications, (b) implications for family members, (c) both personal and family implications or (d) a control letter. The proportion of patients who arrived for appointments was assessed approximately 7 months after mailing along with associations with patient demographics and type of letter received. Letters were mailed to 586 patients who had initial testing between 2001 and 2015. Most patients were white (78%) and female (97%) with private insurance (65%). At 7 months, 25 patients (4.3%, 95% CI: 2.6% to 5.9%) had arrived for an appointment. Older age was significantly associated with response rate (p = .01), while type of recontact letter was not (p = .54). This study suggests that recontacting patients about updated genetic testing by mail does not yield a large response. It also suggests that personal and/or familial implications do not seem to be significant factors that determine response rate. Nevertheless, results provide meaningful information for cancer clinics about the outcomes of recontact efforts via informational letter.",2019,"Older age was significantly associated with response rate (p = .01), while type of recontact letter was not (p = .54).","['Recontacting patients for multigene panel testing in hereditary cancer', 'Most patients were white (78%) and female (97%) with private insurance (65', 'Patients who had negative genetic testing for single genes or conditions', '586 patients who had initial testing between 2001 and 2015']","['letter emphasized different implications of updated multigene genetic testing: (a) personal medical management implications, (b) implications for family members, (c) both personal and family implications or (d) a control letter']",['response rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],586.0,0.0563042,"Older age was significantly associated with response rate (p = .01), while type of recontact letter was not (p = .54).","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sawyer', 'Affiliation': 'Department of Human Genetics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Creswick', 'Affiliation': 'Department of Human Genetics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Human Genetics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Quillin', 'Affiliation': 'Department of Human Genetics, Virginia Commonwealth University, Richmond, VA, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1173']
1500,31568997,Using community health workers to deliver a scalable integrated parenting program in rural China: A cluster-randomized controlled trial.,"Inadequate care during early childhood can lead to long-term deficits in skill development. Parenting programs are promising tools for improving parenting practices and opportunities for healthy development. We implemented a non-masked cluster-randomized controlled trial in rural China in order to assess the effectiveness of an integrated home-visitation program that includes both psychosocial stimulation and health promotion at fostering development and health outcomes of infants and toddlers in rural China. All 6-18 month-old children of two rural townships and their main caregiver were enrolled. Villages were stratified by township and randomly assigned to intervention or control. Specifically, in September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads). In the intervention group, community health workers delivered education and training on how to provide young children with psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion) during bi-weekly home visits over the period of one year. The control group received no home visits. Primary outcomes include measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth). Secondary outcomes are measures of parenting practices. Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD) [95% CI 0·04 SD-0·44 SD] in cognitive development and to a reduction of 8·1 [95% CI 3·8-12·4] percentage points in the risk of diarrheal illness. In addition, we find positive effects on parenting practices mirroring these results. We conclude that an integrated psychosocial stimulation and health promotion program improves development and health outcomes of infants and toddlers (6-30 month-old children) in rural China. Because of low incremental costs of adding program components (that is, adding health promotion to psychosocial stimulation programs), integrated programs may be cost-effective.",2019,Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD),"['infants and toddlers (6-30 month-old children) in rural China', 'rural China', 'All 6-18 month-old children of two rural townships and their main caregiver were enrolled', 'infants and toddlers in rural China', 'September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads']","['scalable integrated parenting program', 'integrated psychosocial stimulation and health promotion program', 'psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion', 'community health workers delivered education and training', 'integrated home-visitation program']","['measures of parenting practices', 'Intention-to-treat (ITT) effects', 'development and health outcomes', '0·24 standard deviations (SD', 'measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",227.0,0.0659255,Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD),"[{'ForeName': 'Renfu', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'China Centre for Agricultural Policy (CCAP), School of Advanced Agricultural Sciences (SAAS), Peking University (PKU), Beijing, China.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Emmers', 'Affiliation': 'LICOS, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Warrinnier', 'Affiliation': 'LICOS, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rozelle', 'Affiliation': 'Freeman Spogli Institute for International Studies, Stanford University, Stanford, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Sylvia', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health and the Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, USA. Electronic address: sean.sylvia@unc.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112545']
1501,29475381,Motivational impairment predicts functional remission in first-episode psychosis: 3-Year follow-up of the randomized controlled trial on extended early intervention.,"OBJECTIVE


Functional remission represents an intermediate functional milestone toward recovery. Differential relationships of negative symptom sub-domains with functional remission in first-episode psychosis are understudied. We aimed to examine rate and predictors of functional remission in people with first-episode psychosis in the context of a 3-year follow-up of a randomized controlled trial comparing 1-year extension of early intervention (i.e. 3-year early intervention) with step-down psychiatric care (i.e. 2-year early intervention).
METHOD


A total of 160 participants were recruited upon completion of a 2-year specialized early intervention program for first-episode psychosis in Hong Kong and underwent a 1-year randomized controlled trial comparing 1-year extended early intervention with step-down care. Participants were followed up and reassessed 3 years after inclusion to the trial (i.e. 3-year follow-up). Functional remission was operationalized as simultaneous fulfillment of attaining adequate functioning (measured by Social and Occupational Functioning Scale and Role Functioning Scale) at 3-year follow-up and sustained employment in the last 6 months of 3-year study period. Negative symptom measure was delineated into amotivation (i.e. motivational impairment) and diminished expression (i.e. reduced affect and speech output). Data analysis was based on 143 participants who completed follow-up functional assessments.
RESULTS


A total of 31 (21.7%) participants achieved functional remission status at 3-year follow-up. Multivariate regression analysis showed that lower levels of amotivation ( p  = 0.010) and better functioning at study intake ( p  = 0.004) independently predicted functional remission (Final model: Nagelkerke  R 2  = 0.40, χ 2  = 42.9,  p  < 0.001). Extended early intervention, duration of untreated psychosis and diminished expression did not predict functional remission.
CONCLUSION


Only approximately one-fifths of early psychosis patients were found to achieve functional remission. Functional impairment remains an unmet treatment need in the early stage of psychotic illness. Our results further suggest that amotivation may represent a critical therapeutic target for functional remission attainment in early psychosis.",2018,"Multivariate regression analysis showed that lower levels of amotivation ( p = 0.010) and better functioning at study intake ( p = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p < 0.001).","['people with first-episode psychosis', 'first-episode psychosis', '143 participants who completed follow-up functional assessments', '160 participants were recruited upon completion of a 2-year specialized early intervention program for first-episode psychosis in Hong Kong and underwent a 1-year randomized controlled trial comparing']","['early intervention (i.e. 3-year early intervention) with step-down psychiatric care (i.e. 2-year early intervention', '1-year extended early intervention with step-down care', 'Motivational impairment']","['levels of amotivation', 'functional remission status', 'functional remission', 'Social and Occupational Functioning Scale and Role Functioning Scale', 'Functional remission']","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}]","[{'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",160.0,0.11344,"Multivariate regression analysis showed that lower levels of amotivation ( p = 0.010) and better functioning at study intake ( p = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p < 0.001).","[{'ForeName': 'Wing Chung', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Vivian Wing Yan', 'Initials': 'VWY', 'LastName': 'Kwong', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Or Chi Fai', 'Affiliation': 'Department of Psychiatry, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Emily Sin Kei', 'Initials': 'ESK', 'LastName': 'Lau', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Gloria Hoi Kei', 'Initials': 'GHK', 'LastName': 'Chan', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Olivia Tsz Ting', 'Initials': 'OTT', 'LastName': 'Jim', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Christy Lai Ming', 'Initials': 'CLM', 'LastName': 'Hui', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sherry Kit Wa', 'Initials': 'SKW', 'LastName': 'Chan', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edwin Ho Ming', 'Initials': 'EHM', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric Yu Hai', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867418758918']
1502,29461413,Cardiac-Autonomic Responses to In-Season Training Among Division-1 College Football Players.,"Flatt, AA, Esco, MR, Allen, JR, Robinson, JB, Bragg, A, Keith, CM, Fedewa, MV, and Earley, RL. Cardiac-autonomic responses to in-season training among Division-1 college football players. J Strength Cond Res 34(6): 1649-1656, 2020-Despite having to endure a rigorous in-season training schedule, research evaluating daily physiological recovery status markers among American football players is limited. The purpose of this study was to determine whether recovery of cardiac-autonomic activity to resting values occurs between consecutive-day, in-season training sessions among college football players. Subjects (n = 29) were divided into groups based on position: receivers and defensive backs (SKILL, n = 10); running backs, linebackers, and tight-ends (MID-SKILL, n = 11) and linemen (LINEMEN, n = 8). Resting heart rate (RHR) and the natural logarithm of the root mean square of successive differences multiplied by 20 (LnRMSSD) were acquired at rest in the seated position before Tuesday and Wednesday training sessions and repeated over 3 weeks during the first month of the competitive season. A position × time interaction was observed for LnRMSSD (p = 0.04), but not for the RHR (p = 0.33). No differences in LnRMSSD between days was observed for SKILL (Tuesday = 82.8 ± 9.3, Wednesday = 81.9 ± 8.7, p > 0.05). Small reductions in LnRMSSD were observed for MID-SKILL (Tuesday = 79.2 ± 9.4, Wednesday = 76.2 ± 9.5, p ≤ 0.05) and LINEMEN (Tuesday = 79.4 ± 10.5, Wednesday = 74.5 ± 11.5, p ≤ 0.05). The individually averaged changes in LnRMSSD from Tuesday to Wednesday were related to PlayerLoad (r = 0.46, p = 0.02) and body mass (r = -0.39, p = 0.04). Cardiac-parasympathetic activity did not return to resting values for LINEMEN or MID-SKILL before the next training session. Larger reductions in LnRMSSD tended to occur in players with greater body mass despite having performed lower workloads, although some individual variability was observed. These findings may have implications for how coaches and support staff address training and recovery interventions for players demonstrating inadequate cardiovascular recovery between sessions.",2020,Cardiac-parasympathetic activity did not return to resting values for LINEMEN or MID-SKILL prior to the next training session.,"['college football players', 'American football players', 'Division-1 College Football Players', 'Subjects (n = 29']",['Season Training'],"['Cardiac-parasympathetic activity', 'Cardiac-Autonomic Responses', 'Resting heart rate (RHR) and the natural logarithm of the root-mean square of successive differences multiplied by twenty (LnRMSSD', 'LnRMSSD']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0016517', 'cui_str': 'Football'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}]","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C1719797', 'cui_str': 'Multiply'}]",29.0,0.0145691,Cardiac-parasympathetic activity did not return to resting values for LINEMEN or MID-SKILL prior to the next training session.,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Flatt', 'Affiliation': 'Department of Health Sciences and Kinesiology, Biodynamics and Human Performance Center, Georgia Southern University (Armstrong Campus), Savannah, Georgia.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Esco', 'Affiliation': 'Department of Kinesiology, Exercise Physiology Laboratory, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Jeff R', 'Initials': 'JR', 'LastName': 'Allen', 'Affiliation': 'Department of Athletics, Sports Medicine, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Robinson', 'Affiliation': 'Department of Athletics, Sports Medicine, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bragg', 'Affiliation': 'Department of Athletics, Performance Nutrition, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Clay M', 'Initials': 'CM', 'LastName': 'Keith', 'Affiliation': 'Department of Athletics, Sports Medicine, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Fedewa', 'Affiliation': 'Department of Kinesiology, Exercise Physiology Laboratory, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Earley', 'Affiliation': 'Department of Biological Sciences, University of Alabama, Tuscaloosa, Alabama.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002475']
1503,29482357,Workplace Mental Health Training in Health Care: Key Ingredients of Implementation.,"OBJECTIVES


Despite growing awareness of the importance of workplace mental health training and an increasing number of educational resources, there is a gap in knowledge regarding what shapes training effectiveness. The purpose of this study was to compare and describe the active ingredients of 2 workplace mental health education programs for health care workers.
METHODS


Within the context of a randomized clinical trial, a multimethod process evaluation was conducted to explore key process elements shaping implementation outcomes: the innovation, service recipients, service providers, and the organizational context. Data collection included descriptive statistics regarding program participation, postprogram interviews with a purposive sample of 18 service recipients, 182 responses to open-ended questions on postgroup and follow-up surveys, and field journal reflections on the process of implementation. Data analysis was informed by an interpretive description approach, using a process evaluation framework to categorize responses from all data sources, followed by within and cross-case comparison of data from both programs.
RESULTS


Five key forces shaped the implementation and perceived outcomes of both programs: a contact-based education approach, information tailored to the workplace context, varied stakeholder perspectives, sufficient time to integrate and apply learning, and organizational support. The Beyond Silence program provided more opportunity for contact-based education, health care-specific content, and in-depth discussion of diverse perspectives.
CONCLUSIONS


To increase mental health literacy and reduce stigma, workplace training should be based on best practice principles of contact-based education, with contextually relevant examples and support from all levels of the organization.",2018,"RESULTS


Five key forces shaped the implementation and perceived outcomes of both programs: a contact-based education approach, information tailored to the workplace context, varied stakeholder perspectives, sufficient time to integrate and apply learning, and organizational support.","['18 service recipients, 182 responses to open-ended questions on postgroup and follow-up surveys, and field journal reflections on the process of implementation', '2 workplace mental health education programs for health care workers', 'Workplace Mental Health Training in Health Care']",[],['mental health literacy'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",,0.0349142,"RESULTS


Five key forces shaped the implementation and perceived outcomes of both programs: a contact-based education approach, information tailored to the workplace context, varied stakeholder perspectives, sufficient time to integrate and apply learning, and organizational support.","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Moll', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'VandenBussche', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Windsor, Ontario, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Kirsh', 'Affiliation': 'Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Stuart', 'Affiliation': ""Bell Canada Mental Health and Anti-Stigma Research Chair, Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Departments of Community Health Sciences and Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'Physical Therapy and Surgery, Western University, London, Ontario, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743718762100']
1504,31630990,"Immunogenicity of chimeric haemagglutinin-based, universal influenza virus vaccine candidates: interim results of a randomised, placebo-controlled, phase 1 clinical trial.","BACKGROUND


Influenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccine and circulating strains, substantially reducing vaccine effectiveness. Moreover, current seasonal vaccines are ineffective against pandemic influenza, and production of a vaccine matched to a newly emerging virus strain takes months. Therefore, there is an unmet medical need for a broadly protective influenza virus vaccine. We aimed to test the ability of chimeric H1 haemagglutinin-based universal influenza virus vaccine candidates to induce broadly cross-reactive antibodies targeting the stalk domain of group 1 haemagglutinin-expressing influenza viruses.
METHODS


We did a randomised, observer-blinded, phase 1 study in healthy adults in two centres in the USA. Participants were randomly assigned to one of three prime-boost, chimeric haemagglutinin-based vaccine regimens or one of two placebo groups. The vaccine regimens included a chimeric H8/1, intranasal, live-attenuated vaccine on day 1 followed by a non-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine on day 85; the same regimen but with the inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine. In this planned interim analysis, the primary endpoints of reactogenicity and safety were assessed by blinded study group. We also assessed anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses in peripheral blood. This trial is registered with ClinicalTrials.gov, number NCT03300050.
FINDINGS


Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned. The adjuvanted inactivated vaccine, but not the live-attenuated vaccine, induced a substantial serum IgG antibody response after the prime immunisation, with a seven times increase in anti-H1 stalk antibody titres on day 29. After boost immunisation, all vaccine regimens induced detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses. An unsolicited adverse event was reported for 29 (48%) of 61 participants. Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo. Solicited systemic adverse events were reported in 14 (56%) of 25 after prime immunisation with intramuscular study product or placebo, in 22 (61%) of 36 after immunisation with intranasal study product or placebo, and in 21 (38%) of 56 after booster doses of study product or placebo. Disaggregated safety data were not available at the time of this interim analysis.
INTERPRETATION


The tested chimeric haemagglutinin-based, universal influenza virus vaccine regimens elicited cross-reactive serum IgG antibodies that targeted the conserved haemagglutinin stalk domain. This is the first proof-of-principle study to show that high anti-stalk titres can be induced by a rationally designed vaccine in humans and opens up avenues for further development of universal influenza virus vaccines. On the basis of the blinded study group, the vaccine regimens were tolerable and no safety concerns were observed.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","['healthy adults in two centres in the USA', 'peripheral blood', 'Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned']","['placebo', 'chimeric haemagglutinin-based vaccine regimens or one of two placebo', 'chimeric H8/1, intranasal, live-attenuated vaccine', 'inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine']","['Solicited systemic adverse events', 'detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses', 'tolerable and no safety concerns', 'anti-H1 stalk antibody titres', 'reactogenicity and safety', 'anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses', 'vaccine effectiveness', 'Solicited local adverse events', 'substantial serum IgG antibody response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",65.0,0.338098,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guptill', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Berlanda-Scorza', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Feser', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA; The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Solórzano', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van der Wielen', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Randy A', 'Initials': 'RA', 'LastName': 'Albrecht', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Buschle', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Yao-Qing', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Claeys', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dickey', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Haley L', 'Initials': 'HL', 'LastName': 'Dugan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ermler', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jenna J', 'Initials': 'JJ', 'LastName': 'Guthmiller', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hai', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Microbiology and Plant Pathology, Institute for Integrative Genome Biology, University of California, Riverside, CA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Henry', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda Yu-Ling', 'Initials': 'LY', 'LastName': 'Lan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Anna-Karin E', 'Initials': 'AE', 'LastName': 'Palm', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dustin G', 'Initials': 'DG', 'LastName': 'Shaw', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Stamper', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Sutton', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Micah E', 'Initials': 'ME', 'LastName': 'Tepora', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wenzel', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Teddy John', 'Initials': 'TJ', 'LastName': 'Wohlbold', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Innis', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'García-Sastre', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Palese', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: florian.krammer@mssm.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30393-7']
1505,31574164,Evaluation of a Multicomponent Care Transitions Program for High-Risk Hospitalized Older Adults.,"OBJECTIVES


To test the effectiveness of a multicomponent care transition intervention targeted at hospitalized patients, aged 75 years and older, at high risk for hospital readmissions, return emergency department (ED) visits, and related complications.
DESIGN


Implementation as a quality improvement program with propensity-matched preintervention and concurrent comparison groups over a 12-month period.
SETTING


A 400-bed community teaching hospital.
PARTICIPANTS


Patients, aged 75 years and older, admitted to non-intensive care unit beds who met specific high-risk criteria. The intervention group included 202 patients, and the concurrent and preintervention comparison groups included 4142 and 4592 patients, respectively.
MEASUREMENTS


Primary outcomes were 30-day hospital readmissions and returns to the ED; 7-day readmissions and ED visits were secondary measures.
RESULTS


Among the 202 patients enrolled in the ""Safe Transitions for At-Risk Patients"" (""STAR"") program, 37 (18.3%) were readmitted within 30 days, in contrast to 14.3% and 14.6% in the concurrent and preintervention comparison groups, respectively. Rates for 30-day return ED visits that did not result in hospitalization were 10.9% in the intervention group, and 7.2% and 7.9% in the comparison groups. STAR patients had greater 30-day ED use than patients in the preintervention comparison group (5.0 percentage points; 95% confidence interval = 0.8-9.3 percentage points; P = .020). Implementation challenges included suboptimal involvement of the participating hospital and post-acute care organizations and a relatively high proportion of patients who did not receive the intervention as planned, despite agreeing to participate before leaving the hospital.
CONCLUSION


A multicomponent care transitions intervention targeting high-risk patients, aged 75 years and older, admitted to a community teaching hospital was not effective in reducing 30- or 7-day readmissions or return ED visits. Our implementation experience offers many lessons for future programs for similar high-risk geriatric populations. J Am Geriatr Soc 67:2634-2642, 2019.",2019,"Rates for 30-day return ED visits that did not result in hospitalization were 10.9% in the intervention group, and 7.2% and 7.9% in the comparison groups.","['202 patients, and the concurrent and preintervention comparison groups included 4142 and 4592 patients, respectively', '202 patients enrolled in the', 'A 400-bed community teaching hospital', 'High-Risk Hospitalized Older Adults', 'Patients, aged 75\u2009years and older, admitted to non-intensive care unit beds who met specific high-risk criteria', 'hospitalized patients, aged 75\u2009years and older, at high risk for hospital readmissions, return emergency department (ED) visits, and related complications', 'targeting high-risk patients, aged 75\u2009years and older, admitted to a community teaching hospital was not effective in reducing 30- or 7-day readmissions or return ED visits']","['Multicomponent Care Transitions Program', 'multicomponent care transitions intervention', 'multicomponent care transition intervention']","['30-day hospital readmissions and returns to the ED; 7-day readmissions and ED visits', '30-day ED', 'hospitalization', 'Safe Transitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",202.0,0.038499,"Rates for 30-day return ED visits that did not result in hospitalization were 10.9% in the intervention group, and 7.2% and 7.9% in the comparison groups.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Huckfeldt', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Reyes', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Engstrom', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.'}, {'ForeName': 'Qingnan', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sanya', 'Initials': 'S', 'LastName': 'Diaz', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Fahmy', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Ouslander', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16189']
1506,31637821,Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa.,"INTRODUCTION


The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa.
METHODS


The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level.
RESULTS


8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited.
CONCLUSIONS


PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register).",2019,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).",['rural South Africa'],"['six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2\xa0×\xa011 clusters opened sequentially', 'universal ART']","['PVS', 'Contextual changes', 'cumulative HIV incidence', 'residency status, HIV status, and HIV care status']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",90.0,0.117108,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Mamadou H', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Plazy', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dabis', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25402']
1507,29469602,Can 5 minutes of repetitive prone press-ups and sustained prone press-ups following a period of spinal loading reverse spinal shrinkage?,"Objective : The objective of this study is to investigate if sustained and repetitive prone press-ups could reverse decreased spinal height following spinal loading and if there was a correlation between the degree of end range of motion spinal extension and spinal height gains.  Design : Pretest-posttest crossover design is used in this study.  Setting : Study was carried out in research laboratory.  Subjects : Forty-one healthy men and women were included in this study.  Intervention : Participants were seated in the stadiometer for 5 min with a 4.5-kg weight placed on each shoulder; the load was removed for 5 min and spinal height was measured using a stadiometer before and after 5 min of repetitive or sustained prone press-ups.  Main Measures : Two-by-two repeated-measures ANOVA to identify significant interactions and main effects is used in this study. Significance of  α  = 0.05. A Pearson correlation coefficient was used to assess the correlation between spinal height changes and spinal extension ROM.  Results : Participants 24.1 ± 2.03 years grew using both repetitive (4.85 ± 3.01 mm) and sustained press ups (4.46 ± 2.57 mm). There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups). There was a significant main effect for time (before vs. after press-ups) ( F (1,30)  = 140.771;  p  < 0.0001; partial  η 2  = 0.82). No correlation was found between the degree of end ROM spinal extension and spinal height changes following press-ups strategies.  Conclusion : Following periods of spinal loading, both repetitive and sustained press-ups increased spinal height. Such strategies could be used to help recover spinal height and limit the effects of decreased spinal height as a result of activities of daily living.",2019,There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups).,['Forty-one healthy men and women were included in this study'],[],"['spinal height changes and spinal extension ROM', 'degree of end ROM spinal extension and spinal height changes', 'spinal height']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",41.0,0.0284328,There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups).,"[{'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Munster', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Brismée', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Phillip S', 'Initials': 'PS', 'LastName': 'Sizer', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Browne', 'Affiliation': 'The University of Texas at El Paso, El Paso, TX, USA.'}, {'ForeName': 'Birendra', 'Initials': 'B', 'LastName': 'Dewan', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Litke', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Pape', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sobczak', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1442539']
1508,31470175,Oral Curcumin No More Effective Than Placebo in Preventing Recurrence of Crohn's Disease After Surgery in a Randomized Controlled Trial.,"BACKGROUND AND AIMS


Recurrence of Crohn's disease (CD) after surgery is a major concern. Curcumin has anti-inflammatory properties and induces endoscopic remission in patients with ulcerative colitis. We investigated the efficacy of curcumin vs placebo in preventing post-operative recurrence of CD, based on endoscopic and clinical indices, in patients receiving concomitant thiopurine therapy.
METHODS


We conducted a double-blind randomized controlled trial at 8 referral centers in France, from October 2014 through January 2018, of 62 consecutive patients with CD undergoing bowel resection. Patients received azathioprine (2.5 mg/kg) and were randomly assigned to groups given oral curcumin (3 g/day; n = 31) or an identical placebo (n = 31) for 6 months, and were then evaluated by colonoscopy. We also collected data on CD activity index, results from laboratory tests, and answers to quality of life questionnaires during this 6-month period. The primary endpoint was postoperative recurrence of CD in each group (Rutgeerts' index score ≥i2) at month 6 (determined by central reading). An interim analysis (intent to treat) was scheduled after 50% of the patients were enrolled.
RESULTS


At month 6, postoperative recurrence (Rutgeerts' index score ≥i2) occurred in 18 patients (58%) receiving curcumin and 21 patients (68%) receiving placebo (P = .60). A significantly higher proportion of patients receiving curcumin (55%) had a severe recurrence of CD (Rutgeerts' index score ≥i3) than patients receiving placebo (26%) (P = .034). We observed a clinical recurrence of CD (CD activity index score >150) at month 6 in 45% of patients receiving placebo and 30% of patients receiving curcumin (P = .80). Quality of life scores at month 6 did not differ significantly between groups (P = .80). Severe adverse events developed in 6% of patients receiving placebo and 16% of patients receiving curcumin (P = .42).
CONCLUSIONS


In a randomized controlled trial of patients who underwent surgery for CD and received thiopurine treatment, we found that curcumin was no more effective than placebo in preventing CD recurrence. There were no significant differences between groups in quality of life or severe adverse events. The study was discontinued after interim analysis due to futility. ClinicalTrials.gov no: NCT 02255370.",2020,"Severe adverse events developed in 6% of patients receiving placebo and 16% of patients receiving curcumin (P=.42).
","['patients with ulcerative colitis', '8 referral centers in France, from October 2014 through January 2018, of 62 consecutive patients with CD undergoing bowel resection', 'patients receiving concomitant thiopurine therapy', 'patients who underwent surgery for CD and received']","['curcumin vs placebo', 'azathioprine', 'Curcumin', 'thiopurine treatment', 'placebo', 'Oral Curcumin', 'Placebo', 'oral curcumin', 'identical placebo']","['quality of life or severe adverse events', 'CD recurrence', 'Severe adverse events', 'severe recurrence of CD', 'clinical recurrence of CD (CD activity index score >150', ""Recurrence of Crohn's Disease"", 'postoperative recurrence of CD', 'CD activity index', 'Quality of life scores', 'postoperative recurrence', 'quality of life questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",62.0,0.550266,"Severe adverse events developed in 6% of patients receiving placebo and 16% of patients receiving curcumin (P=.42).
","[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, Clermont-Ferrand, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': 'Gastroenterology Department, University Hospital, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre Benite, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hebuterne', 'Affiliation': 'Department of Gastroenterology, Archet 2 University Hospital, Nice, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nachury', 'Affiliation': 'Gastroenterology Department, University Hospital, Lille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, University Hospital, Amiens, France; PériTox Laboratory (UMR-I 01), University Health Research Center, Faculty of Medicine, Jules Verne University of Picardy, Amiens, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Richard', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, Laboratoire de Pharmacologie et Toxicologie, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, DRCI, Unité de Biostatistiques, Clermont-Ferrand, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Goutte', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, Clermont-Ferrand, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, Clermont-Ferrand, France. Electronic address: a_buisson@hotmail.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.041']
1509,31629207,Clinical impact of a comprehensive nurse-led discharge intervention on patients being discharged home from an acute medical unit: Randomised controlled trial.,"BACKGROUND


Acute medical units have increasingly been implemented in modern healthcare to ensure a fast track for treatment and care, thus increasing the number of patients being discharged. To avoid early readmissions, new approaches to discharging patients from these settings are needed.
OBJECTIVE


To investigate the clinical impact of a comprehensive nurse-led discharge intervention on patients being discharged home from an acute medical unit.
OUTCOMES


The primary outcome was 30-days hospital readmission. Secondary outcomes were utilisation of healthcare, including contacting emergency departments, the general practitioner or after-hours physicians; patient experience; and health-related quality of life.
DESIGN


This study was a non-blinded randomised clinical controlled trial with a 1 year enrolment period from November 2014 to 2015. Group assignment was performed by computer generated codes.
SETTING


The setting was a 34-bed acute medical unit at a Danish University Hospital.
PARTICIPANTS


Non-surgical patients aged 18+ with more than one contact to hospitals during the last 12 months were eligible for inclusion. Furthermore, patients had to have been discharged home and had a follow-up appointment after discharge.
METHODS


The intervention consisted of (1) an assessment of the patient's overall situation, (2) an assessment of their comprehension of discharge recommendations, (3) a simple discharge letter targeting the individual patient's health literacy and (4) a follow-up telephone call 2 days post-discharge. The study was carried out by a research nurse and the 1st author. Data was collected from medical records, registers and questionnaires. Intention-to-treat and per protocol analysis were performed.
RESULTS


In all, 200 participants were enrolled (101 intervention; 99 control). Of these, 17 were excluded due to transfer to another hospital department and 4 did not receive the full intervention, resulting in 86 in the intervention group and 93 in the control group. At 30 days post-discharge, 22/101 (22%) in the intervention group had at least one readmission vs. 19/99 (19%) in the control group. The total number of all-cause readmissions in the follow-up period was 0.28 (SD: 0.67) in the intervention group vs. 0.26 (SD: 0.63) in the control group. There were no statistically significant differences in baseline characteristics or any of the primary and secondary outcomes.
CONCLUSION


A comprehensive nurse-led discharge model focusing on the individual patient's situation and needs was not capable of reducing readmissions and healthcare utilisation. No statistically significant effects on quality of life or patients' experiences of the discharge from the acute medical unit were observed.",2019,No statistically significant effects on quality of life or patients' experiences of the discharge from the acute medical unit were observed.,"['17 were excluded due to transfer to another hospital department and 4 did not receive the full intervention, resulting in 86 in the intervention group and 93 in the control group', 'Non-surgical patients aged 18+ with more than one contact to hospitals during the last 12 months were eligible for inclusion', 'patients had to have been discharged home and had a follow-up appointment after discharge', '1 year enrolment period from November 2014 to 2015', '200 participants were enrolled (101 intervention; 99 control', 'The setting was a 34-bed acute medical unit at a Danish University Hospital', 'patients being discharged home from an acute medical unit']","[""simple discharge letter targeting the individual patient's health literacy and (4) a follow-up telephone call 2 days post-discharge"", 'comprehensive nurse-led discharge intervention']","['total number of all-cause readmissions', '30-days hospital readmission', 'utilisation of healthcare, including contacting emergency departments, the general practitioner or after-hours physicians; patient experience; and health-related quality of life', 'quality of life']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0019961', 'cui_str': 'Hospital Departments'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",200.0,0.179261,No statistically significant effects on quality of life or patients' experiences of the discharge from the acute medical unit were observed.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Research Centre for Emergency Medicine, Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus, Denmark; The Emergency Department, Aarhus University Hospital, Denmark. Electronic address: marilisb@rm.dk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klingenberg', 'Affiliation': 'The Emergency Department, Amager Hvidovre Hospital, Denmark; The Department of Endocrinology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Ahrensberg', 'Affiliation': 'The Emergency Department, Aarhus University Hospital, Denmark.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Hoeyem', 'Affiliation': 'The Department of Endocrinology, Aarhus University Hospital, Denmark; The Emergency Department, The Regional Hospital in Horsens, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Centre for Emergency Medicine, Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus, Denmark; The Emergency Department, Aarhus University Hospital, Denmark.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103411']
1510,31625952,"Feasibility, Acceptability, and Preliminary Impacts of Web-Based Patient Education on Patients With Schizophrenia Spectrum Disorder: Quasi-Experimental Cluster Study.","BACKGROUND


Web-based interventions are promising tools for increasing the understanding of illness and treatment among patients with serious mental disorders.
OBJECTIVE


This study aimed to test the feasibility and acceptability of a Web-based patient education intervention using a quasi-experimental cluster design to report feedback on patient education sessions and the website used and to report preliminary evidence of the intervention's impact on patients with schizophrenia spectrum disorder.
METHODS


A single-blind, parallel, quasi-experimental cluster study over a 6-month period comparing Web-based education (n=33) with a nonequivalent control group (treatment as usual, n=24) for people with schizophrenia spectrum disorder was conducted. Participants (N=57) were recruited from one psychiatric hospital (6 wards). Feasibility was assessed by participants' commitment (refusal rate, dropout rate) to the study. Acceptability was assessed as participants' commitment to the intervention. Patient education sessions and website feedback were assessed by the patients and health care professionals. The preliminary impact of the sessions on patients' self-efficacy, self-esteem, illness cognition, and knowledge level was measured at baseline and follow-ups (8 weeks, 6 months) with self-rated questionnaires.
RESULTS


The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21). The same result was found for the dropout rates (48% [16/33] vs 58% [14/24]; P=.46). The acceptability of the intervention was good; 31 participants out of 33 (94%) completed all five sessions. Feedback on the intervention was mainly positive; three out of four subscales of session were rated above the midpoint of 4.0. Feedback on the website was also positive, with a grade of good for content (69%, 20/29 patients; 75%, 21/28 professionals), layout (62%, 18/29 patients; 61%, 17/28 professionals), and usability (62%, 18/29 patients; and 68%, 19/28 professionals). The patients using the intervention had significantly higher scores 6 months after the sessions in self-efficacy (baseline mean 26.12, SD 5.64 vs 6-month mean 29.24, SD 6.05; P=.003) and regarding knowledge level about schizophrenia (mean 11.39, SD 4.65 vs 6-month mean 15.06, SD 5.26; P=.002), and lower scores in the subscale of helplessness in illness cognition (mean 2.26, SD 0.96 vs 6-month mean 1.85, SD 0.59; P=.03). Differences from the control group were not significant. No differences were found in patients' self-esteem or other subscales in illness cognition.
CONCLUSIONS


The patients were reluctant to participate in the study and tended to drop out before the follow-ups. Once they had participated, their acceptance of the intervention was high. A more effective recruitment strategy and monitoring method will be needed in future studies. To assess the impact of the intervention, a more rigorous study design with an adequately powered sample size will be used in cooperation with outpatient mental health services.",2019,"The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21).","['patients with schizophrenia spectrum disorder', 'people with schizophrenia spectrum disorder', 'patients with serious mental disorders', 'Participants (N=57) were recruited from one psychiatric hospital (6 wards', 'Patients With Schizophrenia Spectrum Disorder']","['Web-based patient education intervention', 'Web-Based Patient Education']","['dropout rates', 'refusal rate', 'knowledge level about schizophrenia', 'Acceptability', 'subscale of helplessness in illness cognition', ""patients' self-esteem or other subscales in illness cognition"", ""patients' self-efficacy, self-esteem, illness cognition, and knowledge level"", 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",31.0,0.050454,"The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Laine', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Maritta', 'Initials': 'M', 'LastName': 'Välimäki', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Virve', 'Initials': 'V', 'LastName': 'Pekurinen', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Marttunen', 'Affiliation': 'Institute of Criminology and Legal Policy, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}]",Journal of medical Internet research,['10.2196/13073']
1511,29373042,A Test of The Risk Perception Attitude Framework as a Message Tailoring Strategy to Promote Diabetes Screening.,"The risk perception attitude (RPA) framework was tested as a message tailoring strategy to encourage diabetes screening. Participants (N = 602) were first categorized into one of four RPA groups based on their diabetes risk and efficacy perceptions and then randomly assigned to receive a message that matched their RPA, mismatched their RPA, or a control message. Participants receiving a matched message reported greater intentions to engage in self-protective behavior than participants who received a mismatched message or the control message. The results also showed differences in attitudes and behavioral intentions across the four RPA groups. Participants in the responsive group had more positive attitudes toward diabetes screening than the other three groups, whereas participants in the indifferent group reported the weakest intentions to engage in self-protective behavior.",2019,Participants receiving a matched message reported greater intentions to engage in self-protective behavior than participants who received a mismatched message or the control message.,['Participants (N\xa0=\xa0602'],['mismatched message or the control message'],"['greater intentions to engage in self-protective behavior', 'weakest intentions to engage in self-protective behavior', 'risk perception attitude (RPA) framework', 'positive attitudes toward diabetes screening', 'attitudes and behavioral intentions']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",602.0,0.0147726,Participants receiving a matched message reported greater intentions to engage in self-protective behavior than participants who received a mismatched message or the control message.,"[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Rains', 'Affiliation': 'a Department of Communication , University of Arizona.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Hingle', 'Affiliation': 'b Department of Nutritional Sciences , University of Arizona.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Surdeanu', 'Affiliation': 'c Department of Computer Science , University of Arizona.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'd Department of Linguistics , University of Arizona.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kobourov', 'Affiliation': 'c Department of Computer Science , University of Arizona.'}]",Health communication,['10.1080/10410236.2018.1431024']
1512,31056640,Evaluation of a simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins: a randomized study.,"AIMS


We sought to evaluate the efficacy and the safety of a simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement in patients ablated for paroxysmal atrial fibrillation. This consisted of bending the ablation catheter in the left atrium, creating a loop that was cautiously advanced together with the long sheath at the ostium and then within the left superior PV. The curve was then progressively released to reach a stable contact with the anterior part of the left PVs.
METHODS AND RESULTS


Eighty consecutive patients (age 64 ± 11 years, left atrial diameter 43 ± 8 mm) undergoing 'CLOSE'-guided PV isolation were prospectively randomized into two groups depending on whether the loop technique was used or not. When using the loop technique, the encirclement of the left PVs was shorter [20 min (interquartile range, IQR 17-24) vs. 26 min (IQR 18-33), P < 0.01] with a high rate of first pass isolation [(100%) vs. (97%), P = 0.9] and adenosine proof isolation [(93%) vs. (95%), P = 0.67]. Most specifically, at the anterior part of the left PVs, there were less dislocations [0 (IQR 0-0) vs. 1 (IQR 0-4), P < 0.001], radiofrequency duration was shorter (272 ± 85 s vs. 378 ± 122 s, P < 0.001), force-time integral was higher [524 gs (IQR 427-687) vs. 398 gs (IQR 354-451), P < 0.001], average contact force was higher [20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14), P < 0.001].
CONCLUSION


This study describes a simple technique to facilitate catheter stability at the anterior part of the left PVs, resulting in more efficient left PV encirclement without compromising safety.",2019,"[20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14),","[""Eighty consecutive patients (age 64\u2009±\u200911\u2009years, left atrial diameter 43\u2009±\u20098\u2009mm) undergoing 'CLOSE'-guided PV isolation"", 'patients ablated for paroxysmal atrial fibrillation']","['simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement', 'simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins']","['impedance drop', 'average contact force', 'radiofrequency duration', 'force-time integral']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0034090', 'cui_str': 'Vein of lung'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]","[{'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}]",80.0,0.0342701,"[20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14),","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kyriakopoulou', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Strisciuglio', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'El Haddad', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Pooter', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Almorad', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Van Beeumen', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Unger', 'Affiliation': 'CHU Saint Pierre, Brussels, Belgium.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Tavernier', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Duytschaever', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Knecht', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz115']
1513,31297965,"A 96-week, multinational, randomized, double-blind, parallel-group, clinical trial evaluating the safety and effectiveness of bexagliflozin as a monotherapy for adults with type 2 diabetes.","AIM


To explore the safety and effectiveness of extended exposure to bexagliflozin as a monotherapy for type 2 diabetes.
METHODS


Adults with diabetes (n = 288) from the USA, Colombia and Mexico were randomized 1:1 to receive bexagliflozin (20 mg) or placebo for 96 weeks. The primary endpoint was the placebo-adjusted change in HbA1c at 24 weeks. Dosing was continued an additional 72 weeks to assess safety and the durability of the treatment effect. Secondary endpoints measured changes from baseline in body mass and systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 24, and the change, over study duration, in HbA1c .  RESULTS: The placebo-adjusted change in HbA1c from baseline to week 24 was -0.79% (-8.6 mmol/mol) [95%CI -0.53, -1.06 (-5.8, -11.6), P < .0001]. The unadjusted change from baseline through week 96 was -0.55% (-6.0 mmol/mol) ± 1.184% (12.9) (SD) for the bexagliflozin arm compared with 0.53% (5.8 mmol/mol) ± 1.215% (13.3) for the placebo arm (P < .0001). Significant decreases in body mass, SBP and DBP could be attributed to bexagliflozin exposure. The incidence of serious adverse events was lower in the bexagliflozin-treated group (2.8%) than in the placebo group (8.5%). Urinary tract infections occurred less frequently in the active arm (14.5%) than in the placebo arm (20.6%).
CONCLUSIONS


Bexagliflozin at 20 mg/d was well tolerated and provided a durable, clinically meaningful improvement in glycaemic control over 96 weeks to participants in this phase 2 trial. A substantial reduction in weight and blood pressure was produced by bexagliflozin, with no increase in significant adverse event rates.",2019,"Urinary tract infections occurred less frequently in the active arm (14.5%) than in the placebo arm (20.6%).
","['adults with type 2 diabetes', 'type 2 diabetes', 'Adults with diabetes (n = 288) from the USA, Colombia and Mexico']","['Bexagliflozin', 'placebo', 'bexagliflozin']","['incidence of serious adverse events', 'body mass, SBP and DBP', 'body mass and systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 24, and the change, over study duration, in HbA1c ', 'Urinary tract infections', 'safety and effectiveness', 'weight and blood pressure', 'placebo-adjusted change in HbA1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.65103,"Urinary tract infections occurred less frequently in the active arm (14.5%) than in the placebo arm (20.6%).
","[{'ForeName': 'Yuan-Di C', 'Initials': 'YC', 'LastName': 'Halvorsen', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Massaro', 'Affiliation': 'Department of Biostatistics, Mathematics and Statistics, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Aftring', 'Affiliation': 'Theracos, Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Mason W', 'Initials': 'MW', 'LastName': 'Freeman', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13833']
1514,29338313,Rapport Building and Instructional Fading Prior to Discrete Trial Instruction: Moving From Child-Led Play to Intensive Teaching.,"Discrete trial instruction (DTI) is effective for teaching skills to children with autism spectrum disorder (ASD). Although effective, instructional settings can become aversive resulting in avoidant and escape-related behaviors. Given the significant social impairments associated with ASD, interventions that promote social approach and reduce avoidance are warranted. Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction. However, the path from child-led play to DTI is not well established. Instructional fading may assist in bridging this gap. Four participants with ASD who were beginning an intensive behavioral intervention program were included in the current study. Participants progressed through nine stages of pairing and instructional fading with minimal problem behavior and high percentages of in-seat and close proximity to the therapist. Guidelines for incorporating rapport building strategies prior to intensive teaching with children with ASD are proposed.",2019,"Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction.","['children with autism spectrum disorder (ASD', 'children with ASD', 'Four participants with ASD who were beginning an intensive behavioral intervention program were included in the current study']","['Rapport Building and Instructional Fading Prior to Discrete Trial Instruction', 'Discrete trial instruction (DTI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",[],4.0,0.0212809,"Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction.","[{'ForeName': 'M Alice', 'Initials': 'MA', 'LastName': 'Shillingsburg', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Marcus Autism Center, Atlanta, GA, USA.'}]",Behavior modification,['10.1177/0145445517751436']
1515,31621640,"Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus.","BACKGROUND


Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM).
OBJECTIVE


This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT).
METHODS


The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes.
RESULTS


A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were -2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA 1c  (P value for change over time <.001).
CONCLUSIONS


The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506.",2019,"Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM).
","['Ethnic Minority Adults With Type 2 Diabetes Mellitus', 'ethnic minority patients with T2DM', 'low-socioeconomic status (SES) ethnic minority patients with T2DM and (2', 'Diabetes-Related Dietary Knowledge', 'ethnically diverse populations', 'A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively', '50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics']","['4-session dietician-delivered lifestyle counseling intervention', 'standard lifestyle advice (SLA', '4 in-person, dietician-delivered counseling sessions', 'adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling', 'Electronic, Culturally Adapted Lifestyle Counseling Tool']","['total energy', 'mean (SE) differences in added sugar and dietary fiber intakes', 'efficiency of lifestyle education', 'DM-related dietary knowledge', 'DM-related lifestyle knowledge', 'odds of engaging in any leisure PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]",25.0,0.0828352,"Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM).
","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Abu-Saad', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Havi', 'Initials': 'H', 'LastName': 'Murad', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Rivka', 'Initials': 'R', 'LastName': 'Barid', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Liraz', 'Initials': 'L', 'LastName': 'Olmer', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Arnona', 'Initials': 'A', 'LastName': 'Ziv', 'Affiliation': 'Information and Computerization Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Nuha', 'Initials': 'N', 'LastName': 'Younis-Zeidan', 'Affiliation': 'Diet and Nutrition Service Unit for the Arab population in Sharon-Shomron District, Clalit Health Services, Arara, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Kaufman-Shriqui', 'Affiliation': 'Department of Nutritional Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gillon-Keren', 'Affiliation': ""Institute of Endocrinology and Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel.""}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Rigler', 'Affiliation': 'Sharon-Shomron District, Clalit Health Services, Hadera, Israel.'}, {'ForeName': 'Yakir', 'Initials': 'Y', 'LastName': 'Berchenko', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Kalter-Leibovici', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}]",Journal of medical Internet research,['10.2196/13674']
1516,31619358,Randomized Clinical Trial Comparing Femtosecond LASIK and Small-Incision Lenticule Extraction.,"PURPOSE


To compare femtosecond LASIK with small-incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism.
DESIGN


Prospective, randomized, paired-eye, single-masked clinical trial.
PARTICIPANTS


Consecutive eligible patients were randomized to undergo SMILE and LASIK in either eye at a single tertiary referral eye center.
METHODS


Patients were treated in each eye using the VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system. Excimer ablation was subsequently performed using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX) in the eye for LASIK.
MAIN OUTCOME MEASURE


Refractive predictability at 3 months. Secondary outcomes were refractive outcomes, that is, efficacy and safety at 3 and 12 months.
RESULTS


We recruited 70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P = 0.87). At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved SE within ±1.0 D of attempted correction (P = 1.0). Small-incision lenticule extraction achieved similar results as LASIK in terms of efficacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), uncorrected distance visual acuity (UDVA) of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63). Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months. At 12 months, SMILE was similar to LASIK in terms of efficacy (85% vs. 83% UDVA ≥20/20; P = 0.81), predictability (99% vs. 99% ±1.0 D of attempted correction SE; P = 1.0), and safety (1.15±0.20 vs. 1.15±0.20; P = 0.93).
CONCLUSIONS


The results from this randomized trial suggest that SMILE produced promising refractive outcomes in terms of predictability, efficacy, and safety at 3 and 12 months of follow-up.",2020,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"['Consecutive eligible patients', 'Patients were treated in each eye using the', 'in either eye at a single tertiary referral eye center', '70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P\xa0= 0.87']","['VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system', 'Excimer ablation', 'Femtosecond LASIK and Small-Incision Lenticule Extraction', 'SMILE and LASIK', 'WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX', 'SMILE', 'femtosecond LASIK with small-incision lenticule extraction (SMILE']","['refractive outcomes, that is, efficacy and safety', 'uncorrected distance visual acuity (UDVA', 'Safety index', 'predictability', 'predictability, efficacy, and safety', 'Refractive predictability', 'efficacy index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}]","[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",70.0,0.216313,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ang', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore. Electronic address: marcus.ang@snec.com.sg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farook', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore.'}, {'ForeName': 'Hla M', 'Initials': 'HM', 'LastName': 'Htoon', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.006']
1517,30067578,"Presenting Characteristics Associated With Outcome in Children With Severe Traumatic Brain Injury: A Secondary Analysis From a Randomized, Controlled Trial of Therapeutic Hypothermia.","OBJECTIVES


To identify injury patterns and characteristics associated with severe traumatic brain injury course and outcome, within a well-characterized cohort, which may help guide new research and treatment initiatives.
DESIGN


A secondary analysis of a phase 3, randomized, controlled trial that compared therapeutic hypothermia versus normothermia following severe traumatic brain injury in children.
SETTING


Fifteen sites in the United States, Australia, and New Zealand.
PATIENTS


Children (< 18 yr old) with severe traumatic brain injury.
MEASUREMENTS AND MAIN RESULTS


Baseline, clinical, and CT characteristics of patients (n = 77) were examined for association with mortality and outcome, as measured by the Glasgow Outcome Scale-Extended Pediatric Revision 3 months after traumatic brain injury. Data are presented as odds ratios with 95% CIs. No demographic, clinical, or CT characteristic was associated with mortality in bivariate analysis. Characteristics associated with worse Glasgow Outcome Scale-Extended Pediatric Revision in bivariate analysis were two fixed pupils (14.17 [3.38-59.37]), abdominal Abbreviated Injury Severity score (2.03 [1.19-3.49]), and subarachnoid hemorrhage (3.36 [1.30-8.70]). Forward stepwise regression demonstrated that Abbreviated Injury Severity spine (3.48 [1.14-10.58]) and midline shift on CT (8.35 [1.05-66.59]) were significantly associated with mortality. Number of fixed pupils (one fixed pupil 3.47 [0.79-15.30]; two fixed pupils 13.61 [2.89-64.07]), hypoxia (5.22 [1.02-26.67]), and subarachnoid hemorrhage (3.01 [1.01-9.01]) were independently associated with worse Glasgow Outcome Scale-Extended Pediatric Revision following forward stepwise regression.
CONCLUSIONS


Severe traumatic brain injury is a clinically heterogeneous disease that can be accompanied by a range of neurologic impairment and a variety of injury patterns at presentation. This secondary analysis of prospectively collected data identifies several characteristics associated with outcome among children with severe traumatic brain injury. Future, larger trials are needed to better characterize phenotypes within this population.",2018,Forward stepwise regression demonstrated that Abbreviated Injury Severity spine (3.48 [1.14-10.58]) and midline shift on CT (8.35 [1.05-66.59]) were significantly associated with mortality.,"['children with severe traumatic brain injury', 'Fifteen sites in the United States, Australia, and New Zealand', 'Children With Severe Traumatic Brain Injury', 'Children (< 18 yr old) with severe traumatic brain injury', 'severe traumatic brain injury in children']",['therapeutic hypothermia versus normothermia'],"['Number of fixed pupils', 'abdominal Abbreviated Injury Severity score', 'hypoxia', 'Abbreviated Injury Severity spine', 'subarachnoid hemorrhage', 'mortality', 'worse Glasgow Outcome Scale-Extended Pediatric Revision']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0235804', 'cui_str': 'Fixed Pupils'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}]",77.0,0.280572,Forward stepwise regression demonstrated that Abbreviated Injury Severity spine (3.48 [1.14-10.58]) and midline shift on CT (8.35 [1.05-66.59]) were significantly associated with mortality.,"[{'ForeName': 'Bedda L', 'Initials': 'BL', 'LastName': 'Rosario', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Horvat', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Panigrahy', 'Affiliation': 'Department of Radiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Zuccoli', 'Affiliation': 'Department of Radiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Srikala', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'Department of Radiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Goundappa K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'P David', 'Initials': 'PD', 'LastName': 'Adelson', 'Affiliation': ""Department of Neurological Surgery, Barrow Neurological Institute of Phoenix Children's Hospital, Phoenix, AZ.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001676']
1518,31620939,"Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study.","OBJECTIVE


The aim of this 12-month mono-centre double-blind randomized placebo-controlled clinical study was to evaluate the efficacy of Lactobacillus reuteri-containing lozenges during the supportive therapy of generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients.
MATERIAL AND METHODS


Twenty treated GPIII-IVC patients were randomly divided into 2 groups. The test group received two 3-month-long administrations of L. reuteri (2 lozenges/day after brushing) with a 3-month washout period, while the control one received a placebo. Outcome measures were tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment. Measurements were collected at 3, 6, 9 and 12 months.
RESULTS


At 1 year, no dropout, tooth loss, complications or adverse event were recorded. Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
CONCLUSIONS


Within the limitation of the study, the use of L. reuteri probiotics lozenges improved some clinical outcomes in treated GPIII-IVC patients during maintenance therapy. Studies with a larger number of patients are needed to confirm these data.
CLINICAL RELEVANCE


The use of L. reuteri probiotic lozenges could be considered as an adjunct in the maintenance therapy of GPIII-IVC patients.",2020,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","['generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients', 'Twenty treated GPIII-IVC patients', 'GPIII-IVC patients', 'generalized periodontitis stage III and IV, grade C', 'treated GPIII-IVC patients during maintenance therapy']","['placebo', 'L. reuteri probiotic lozenges', 'Lactobacillus reuteri-containing lozenges']","[""tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment"", 'BOP reduction', 'dropout, tooth loss, complications or adverse event', 'PAL gain', 'Mean PPD and mean PAL and percentages of sites with BOP', 'PPD reduction']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441807', 'cui_str': 'Grade C (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080233', 'cui_str': 'Tooth Loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",,0.306097,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","[{'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Grusovin', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy. Gabri.grusovin@tiscali.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bossini', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Cappa', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Garzetti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Eleonara', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Enrico Felice', 'Initials': 'EF', 'LastName': 'Gherlone', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Mensi', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}]",Clinical oral investigations,['10.1007/s00784-019-03065-x']
1519,31371810,Long-term intake of miso soup decreases nighttime blood pressure in subjects with high-normal blood pressure or stage I hypertension.,"The present study aimed to investigate the effects of the combination of Marukome Nenrin miso, which has natriuretic effects, and Marukome MK-34-1 miso, which has potent angiotensin converting enzyme inhibitory effects, on blood pressure (BP) in humans. A total of 40 subjects aged 40-69 years with high-normal BP or stage I hypertension were randomly assigned to two groups: 1) the miso group (32 g 2:1 w/w Nenrin and MK-34-1 with 3.8 g salt/day) or 2) the control soy food group (14.4 g soy food with 0.2 g salt/day). The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving. Daytime and nighttime BP were measured with an automated BP monitor. Compared with the soy food intake, miso intake for 8 weeks did not affect daytime clinical BP but significantly decreased nighttime BP without affecting pulse rate (PR). Moreover, miso shifted the nighttime BP profile to lower levels than those at baseline. Soy food intake did not change the nighttime BP profile after 8 weeks. Miso intake also tended to reduce nighttime BP in a subgroup with stage 1 hypertension compared with the results of the soy food group participants and shifted the nighttime BP profile toward lower levels than those recorded at baseline. Miso intake did not influence lipid or glucose metabolism. In conclusion, this is the first report showing that miso reduces nighttime BP in humans. Miso may do so by shrinking the fluid spaces in the body and/or deactivating the adrenergic nervous system.",2019,"The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving.","['humans', '40 subjects aged 40-69 years with high-normal BP or stage', 'subjects with high-normal blood pressure or stage I hypertension', 'I hypertension']",['miso group (32\u2009g 2:1 w/w Nenrin and MK-34-1 with 3.8\u2009g salt/day) or 2) the control soy food group (14.4\u2009g soy food with 0.2\u2009g salt/day'],"['levels of major nutrients', 'nighttime BP without affecting pulse rate (PR', 'daytime clinical BP', 'nighttime BP profile', 'nighttime blood pressure', 'lipid or glucose metabolism', 'Daytime and nighttime BP', 'nighttime BP', 'blood pressure (BP', 'nighttime BP profile toward lower levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0453222', 'cui_str': 'Miso'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C2919747', 'cui_str': 'Weight/weight ratio'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1258091', 'cui_str': 'Soy Foods'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",40.0,0.0318783,"The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving.","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Meiseikai Higashi Shinjuku Clinic, 3F Daito-bldg., 1-11-3 Okubo, Shinjuku-Ku, 169-0072, Japan.'}, {'ForeName': 'Hiroe', 'Initials': 'H', 'LastName': 'Sakuyama Tomari', 'Affiliation': ""Division of Clinical Nutrition, Faculty of Home Economics, Kyoritsu Women's University, Tokyo, Japan.""}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': ""Division of Clinical Nutrition, Faculty of Home Economics, Kyoritsu Women's University, Tokyo, Japan.""}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Minami', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Seiki', 'Initials': 'S', 'LastName': 'Itou', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'TTC Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Food Therapeutic Lab, Tokyo, Japan. yoshiodr@nn.iij4u.or.jp.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0304-9']
1520,29331848,"Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.","Apathy is a common and disabling behavioral concomitant of many neurodegenerative conditions. The presence of apathy with Mild Cognitive Impairment (MCI) is linked with heightened rates of conversion to Alzheimer's disease. Improving apathy may slow the neurodegenerative process. The objective was to establish the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving apathy in older adults with MCI. An 8-week, double-blind, randomized, sham-controlled cross-over study was conducted in nine subjects (66 ± 9 years) with apathy and MCI. Subjects were randomized to rTMS or sham treatment (5 days/week) for 2 weeks following which they underwent a 4-week treatment-free period. Subjects then crossed-over to receive the other treatment for 2 weeks. The primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes were assessed at baseline, 2, 6, and 8 weeks. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment at 2 weeks. There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI-I with rTMS compared to the sham treatment. This study establishes that rTMS is efficacious in improving apathy in subjects with MCI.",2018,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","['older adults with MCI', 'subjects with MCI', 'mild cognitive impairment', 'nine subjects (66 ± 9 years) with apathy and MCI']","['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS, MMSE, TMT-A, and CGI', 'primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.25973,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA. Electronic address: Prasad.Padala@va.gov.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Jackson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Bopp', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Mennemeier', 'Affiliation': 'Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Roberson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Sullivan', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]",Psychiatry research,['10.1016/j.psychres.2017.12.063']
1521,31578111,Intraoperative superior hypogastric plexus block during cesarean section: a new technique for pain relief.,"Background:  With increasing cesarean section rates all around the world, postoperative pain management is an important issue for all women. Good postoperative pain management helps to shorten the recovery period of the mother, improve the mother's feeling of well-being, enable good breastfeeding, and provide optimum maternal-neonatal bonding. Objective:  To evaluate the efficacy of intraoperative superior hypogastric plexus block (SHPB) during cesarean section and describe the technique. Study design:  This was a prospective quasi-experimental study that was conducted with 69 pregnant women at HSU. Kocaeli Derince Training and Research Hospital Obstetrics and Gynecology Clinics between 15 March 2018 and 15 August 2018. The case group included 34 healthy pregnant women who received SHPB (SHPB+) for postoperative pain relief during cesarean section under general anesthesia, and the control group included 35 healthy pregnant women who did not receive SHPB during cesarean section with general anesthesia (SHPB-). Postoperative 1st hour, 6th hour, 12th hour, 24th hour, and 48th hour visual analog scale (VAS) scores, the amount of analgesics used for pain relief, and the time of the postoperative first gas extraction were assessed. Results:  The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p  < .001). The mean postoperative 1st hour VAS score of the SHPB (+) group was 4.74 ± 1.44, and was 6.80 ± 2.08 for the SHPB (-) group. There were no differences in postoperative 6th hour, 12th hour, 24th hour, and 48th hour VAS scores between the groups. When the SHPB (+) and SHPB (-) groups were compared for postoperative analgesic use and for the first postoperative gas extraction time, the SHPB (+) group had lower analgesic use ( p  < .001), and the SHPB (-) group had earlier gas extraction. The mean analgesic use in the SHPB (+) group was 2.29 ± 1.11 and it was 4 ± 0.84 in SHPB (-) group. The mean gas extraction time for the SHPB (-) group was 18.03 ± 7.2 h, and was 24.56 ± 8.56 h for the SHPB (+) group ( p  = .001). Conclusion:  SHPB performed intraoperatively in cesarean section procedures with general anesthesia is a simple, easy approach to perform during open surgery with direct vision. SHPB helps postoperative pain management extensively with low postoperative VAS scores and low analgesic requirement.",2019,The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p  < 0.001).,"['34 healthy pregnant women who received', 'cesarean section', '69 pregnant women at HSU', 'cesarean section procedures with general anesthesia', 'for postoperative pain relief during cesarean section under general anesthesia, and the control group included 35 healthy pregnant women who did not receive SHPB during cesarean section with general anesthesia (SHPB ']","['intraoperative superior hypogastric plexus block (SHPB', 'Intraoperative superior hypogastric plexus block', 'SHPB (SHPB ', 'SHPB']","['mean gas extraction time', 'VAS scores', '48th hour visual analogue scale (VAS) scores', 'cesarean section rates', 'pain relief, and the time of the postoperative first gas extraction', 'mean analgesic use', 'mean postoperative 1st hour VAS score', 'postoperative 6th hour, 12th hour, 24th hour, and 48th hour VAS scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0229047', 'cui_str': 'Structure of superior hypogastric plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}]",35.0,0.0289746,The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p  < 0.001).,"[{'ForeName': 'Bahar Sarıibrahim', 'Initials': 'BS', 'LastName': 'Astepe', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hande Gürbüz', 'Initials': 'HG', 'LastName': 'Aytuluk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ünal', 'Initials': 'Ü', 'LastName': 'Türkay', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1676414']
1522,31621995,Exercise before bed does not impact sleep inertia in young healthy males.,"Sleep inertia is the transitional state marked by impaired cognitive performance and reduced vigilance upon waking. Exercising before bed may increase the amount of slow-wave sleep within the sleep period, which has previously been associated with increased sleep inertia. Healthy males (n = 12) spent 3 nights in a sleep laboratory (1-night washout period between each night) and completed one of the three conditions on each visit - no exercise, aerobic exercise (30 min cycling at 75% heart rate), and resistance exercise (six resistance exercises, three sets of 10 repetitions). The exercise conditions were completed 90 min prior to bed. Sleep was measured using polysomnography. Upon waking, participants completed five test batteries every 15 min, including the Karolinska Sleepiness Scale, a Psychomotor Vigilance Task, and the Spatial Configuration Task. Two separate linear mixed-effects models were used to assess: (a) the impact of condition; and (b) the amount of slow-wave sleep, on sleep inertia. There were no significant differences in sleep inertia between conditions, likely as a result of the similar sleep amount, sleep structure and time of awakening between conditions. The amount of slow-wave sleep impacted fastest 10% reciprocal reaction time on the Psychomotor Vigilance Task only, whereby more slow-wave sleep improved performance; however, the magnitude of this relationship was small. Results from this study suggest that exercise performed 90 min before bed does not negatively impact on sleep inertia. Future studies should investigate the impact of exercise intensity, duration and timing on sleep and subsequent sleep inertia.",2020,"There were no significant differences in sleep inertia between conditions, likely as a result of the similar sleep amount, sleep structure and time of awakening between conditions.","['Healthy males (n\xa0=\xa012) spent 3\u2009nights in a sleep laboratory (1-night washout period between each night) and completed one of the three conditions on each', 'young healthy males']","['visit - no exercise, aerobic exercise (30\xa0min cycling at 75% heart rate), and resistance exercise (six resistance exercises']","['slow-wave sleep improved performance', 'Sleep', 'Karolinska Sleepiness Scale, a Psychomotor Vigilance Task, and the Spatial Configuration Task', 'sleep inertia', 'similar sleep amount, sleep structure and time of awakening']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]","[{'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C1963765', 'cui_str': 'Sleep inertia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",,0.0167339,"There were no significant differences in sleep inertia between conditions, likely as a result of the similar sleep amount, sleep structure and time of awakening between conditions.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Sargent', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Miller', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Kovac', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Scanlan', 'Affiliation': 'Human Exercise and Training Laboratory, Central Queensland University, Rockhampton, QLD, Australia.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Waggoner', 'Affiliation': 'Operational Fatigue Research, Institutes for Behavior Resources, Inc., Baltimore, MD, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Lastella', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}]",Journal of sleep research,['10.1111/jsr.12903']
1523,31492643,Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial.,"BACKGROUND


Irritable bowel syndrome (IBS) is common, affecting 10-20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial.
METHODS


In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879.
FINDINGS


24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40·5 points (95% CI 15·0 to 66·0; p=0·002) lower in the telephone-CBT group and 12·9 points (-12·9 to 38·8; p=0·33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3·1 points (1·3 to 4·9; p<0·001) lower in the telephone-CBT group and 1·9 points (0·1 to 3·7; p=0·036) lower in the web-CBT group than in the TAU group. A clinically significant IBS-SSS change (≥50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment.
INTERPRETATION


At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit.
FUNDING


UK National Institute for Health Research.",2019,"At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes.","['irritable bowel syndrome', 'Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016', 'adults with refractory IBS', '558 adults with refractory IBS', 'participants in the ACTIB trial', 'patients with refractory IBS']","['Cognitive behavioural therapy', 'Cognitive behavioural therapy (CBT', 'therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group', 'CBT']","['IBS symptom severity', 'mean IBS-SSS', 'mean WSAS score', 'IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation', 'IBS', 'IBS-SSS change']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",558.0,0.1374,"At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes.","[{'ForeName': 'Hazel A', 'Initials': 'HA', 'LastName': 'Everitt', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK. Electronic address: hae1@soton.ac.uk.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gilly', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Windgassen', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Bishop', 'Affiliation': 'Centre for Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'Department of Gastroenterology, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30243-2']
1524,29276837,Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment.,"Research suggests that the progressive abandonment of activities in cancer patients are related to depression and worse quality of life. Behavioral activation (BA) encourages subjects to activate their sources of reinforcement and modify the avoidance responses. This study assesses the effectiveness of BA in improving quality of life and preventing emotional disorders during chemotherapy treatment. One sample of lung cancer patients and another of breast cancer patients were randomized into a BA experimental group (E.G. lung/4sess . n  = 50; E.G. breast/6sess . n  = 33) and a control group (C.G. lung/4sess . n  = 40; C.G. breast/6sess. n  = 35), respectively. In each session and in follow-ups (3/6/9 months), all participants completed different assessment scales. The results converge to show the effectiveness of BA, encouraging cancer patients to maintain rewarding activities which can activate their sources of day-to-day reinforcement and modify their experience avoidance patterns. BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.",2019,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"['n = 50', 'lung cancer patients and another of breast cancer patients', 'Lung Cancer and Breast Cancer Patients', 'cancer patients', 'n = 40']","['BA', 'Behavioral Activation']","['Quality of Life and Emotional State', 'quality of life and preventing emotional disorders']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}]",,0.0171,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"[{'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Villoria-Fernández', 'Affiliation': 'Universidad Autónoma de Chile, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fernández-García', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'González-Fernández', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'University of Oviedo, Spain.'}]",Behavior modification,['10.1177/0145445517746915']
1525,31596648,A novel telehealth platform for alcohol use disorder treatment: preliminary evidence of reductions in drinking.,"BACKGROUND


Alcohol use disorder (AUD) treatment remains greatly underutilized. Innovative strategies are needed to improve AUD treatment access and patient engagement. The Ria Treatment Platform (RTP) is a patient-centered telemedicine AUD treatment program accessed through a smartphone application (app) that includes a package of physician visits (with AUD prescriptions as appropriate), text- and phone-based support from a recovery coach, video monitoring of medication adherence, and Bluetooth-linked breathalyzer tracking of alcohol intake.
OBJECTIVES


The purpose of the current study is to examine changes in alcohol use among patients utilizing the RTP.
METHODS


This study examines daily breathalyzer blood alcohol content (BAC) readings collected from 77 adult patients (50.7% male) over the first 90 days in treatment with the RTP. Data were analyzed using dynamic structural equation modeling.
RESULTS


The treatment retention rate at 90 days was 55%. The best fit for the BAC data was given by a cubic curve, which showed that among patients who remained engaged for 90 days average BAC levels declined approximately 50% (from .091 to .045) from baseline to day 90.
CONCLUSION


This study provides preliminary evidence of substantial alcohol use reductions among patients utilizing the RTP, an innovative telemedicine program accessed via smartphone. Although other alcohol-reduction apps have shown promise from scientific evaluations, the RTP appears to be the only app that incorporates physician-prescribed medication and a recovery coach. Research incorporating random assignment and meaningful comparison groups is needed to further evaluate this promising strategy.",2020,"The Ria Treatment Platform (RTP) is a patient-centered telemedicine AUD treatment program accessed through a smartphone application (app) that includes a package of physician visits (with AUD prescriptions as appropriate), text- and phone-based support from a recovery coach, video monitoring of medication adherence, and Bluetooth-linked breathalyzer tracking of alcohol intake.  ","['patients utilizing the RTP', '77 adult patients (50.7% male) over the first 90\xa0days in treatment with the RTP']",[' '],"['treatment retention rate', 'BAC levels', 'daily breathalyzer blood alcohol content (BAC) readings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",77.0,0.0171058,"The Ria Treatment Platform (RTP) is a patient-centered telemedicine AUD treatment program accessed through a smartphone application (app) that includes a package of physician visits (with AUD prescriptions as appropriate), text- and phone-based support from a recovery coach, video monitoring of medication adherence, and Bluetooth-linked breathalyzer tracking of alcohol intake.  ","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute , Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mendelson', 'Affiliation': 'Ria Health , San Francisco, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute , Baltimore, MD, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Carswell', 'Affiliation': 'Friends Research Institute , Baltimore, MD, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute , Baltimore, MD, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1658197']
1526,31607467,"Strategies to improve control of sexually transmissible infections in remote Australian Aboriginal communities: a stepped-wedge, cluster-randomised trial.","BACKGROUND


Remote Australian Aboriginal communities have among the highest diagnosed rates of sexually transmissible infections (STIs) in the world. We did a trial to assess whether continuous improvement strategies related to sexual health could reduce infection rates.
METHODS


In this stepped-wedge, cluster-randomised trial (STIs in remote communities: improved and enhanced primary health care [STRIVE]), we recruited primary health-care centres serving Aboriginal communities in remote areas of Australia. Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population. The health-care centres were grouped into clusters on the basis of geographical proximity to each other, population size, and Aboriginal cultural ties including language connections. Clusters were randomly assigned into three blocks (year 1, year 2, and year 3 clusters) using a computer-generated randomisation algorithm, with minimisation to balance geographical region, population size, and baseline STI testing level. Each year for 3 years, one block of clusters was transitioned into the intervention phase, while those not transitioned continued usual care (control clusters). The intervention phase comprised cycles of reviewing clinical data and modifying systems to support improved STI clinical practice. All investigators and participants were unmasked to the intervention. Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. We used Poisson regression analyses on the final dataset and compared STI prevalences and testing coverage between control and intervention clusters. All analyses were by intention to treat and models were adjusted for time as an independent covariate in overall analyses. This study was registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12610000358044.
FINDINGS


Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11 286), year 2 clusters (n=10 288), or year 3 clusters (n=13 304). One primary health-care centre withdrew from the study due to restricted capacity to participate. We detected no difference in the relative prevalence of STIs between intervention and control clusters (adjusted relative risk [RR] 0·97, 95% CI 0·84-1·12; p=0·66). However, testing coverage was substantially higher in intervention clusters (22%) than in control clusters (16%; RR 1·38; 95% CI 1·15-1·65; p=0·0006).
INTERPRETATION


Our intervention increased STI testing coverage but did not have an effect on prevalence. Additional interventions that will provide increased access to both testing and treatment are required to reduce persistently high prevalences of STIs in remote communities.
FUNDING


Australian National Health and Medical Research Council.",2019,"Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.","['recruited primary health-care centres serving Aboriginal communities in remote areas of Australia', 'Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11\u2008286), year 2 clusters (n=10\u2008288), or year 3 clusters (n=13\u2008304', 'Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population', 'remote Australian Aboriginal communities']",[],"['community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis', 'STI testing coverage', 'relative prevalence of STIs']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0027573', 'cui_str': 'Gonococcus'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",68.0,0.145662,"Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Flinders University, Adelaide, SA, Australia. Electronic address: james.ward@sahmri.com.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Guy', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alice R', 'Initials': 'AR', 'LastName': 'Rumbold', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Samson Institute, Adelaide University, Adelaide, SA, Australia; Menzies School of Health Research, Darwin, NT, Australia.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'McGregor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McManus', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amalie', 'Initials': 'A', 'LastName': 'Dyda', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garton', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Northern Territory Department of Health, Darwin, NT, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Hengel', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Apunipima Cape York Health Council, Cairns, QLD, Australia.'}, {'ForeName': 'Bronwyn J', 'Initials': 'BJ', 'LastName': 'Silver', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Taylor-Thomson', 'Affiliation': 'Menzies School of Health Research, Darwin, NT, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Maher', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Melbourne, VIC, Australia; Central Clinical School Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Skov', 'Affiliation': 'Northern Territory Department of Health, Darwin, NT, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Ryder', 'Affiliation': 'Northern Territory Department of Health, Darwin, NT, Australia; Hunter New England Health Service, Newcastle, NSW, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Moore', 'Affiliation': 'Aboriginal Medical Services Alliance, Darwin, NT, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mein', 'Affiliation': 'Wuchopperen Aboriginal Health Service, Cairns, QLD, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Reeve', 'Affiliation': 'James Cook University, Cairns, QLD, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Ah Chee', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boffa', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30411-5']
1527,29231046,An Assessment of the Effects of Hydrotherapy During the Active Phase of Labor on the Labor Process and Parenting Behavior.,"This study was conducted to assess the effect on labor process and parenting behavior of hydrotherapy applied during the active phase of labor. This quasi-experimental study was conducted by using an equivalent comparison group ( n  = 40). The participants in the experimental group whose cervical dilation was 5 cm were taken to the hydrotherapy tub. This application continued until cervical dilation reached 10 cm. The Participants Questionnaire, The Birth Follow-up Questionnaire, The Postpartum ]collection tools. The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p  = .001). The Visual Analogue Scale (VAS) scores of the experimental group were lower than those of the equivalent comparison group when cervical dilation was 6 cm and 10 cm ( p  = .001). The experimental group also displayed more positive parenting behavior and positive labor feeling ( p  = .001).",2019,The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001).,[],['Hydrotherapy'],"['cervical dilation', 'Visual Analogue Scale (VAS) scores', 'duration of the active phase and second stage of labor', 'positive parenting behavior and positive labor feeling']",[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",40.0,0.0256603,The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001).,"[{'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Tuncay', 'Affiliation': ""Zekai Tahir Burak Women's Health Education and Research Hospital, Ankara, Turkey.""}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Kaplan', 'Affiliation': 'Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Moraloglu Tekin', 'Affiliation': ""Etlik Zubeyde Hanim Women's Health Education and Research Hospital, Ankara, Turkey.""}]",Clinical nursing research,['10.1177/1054773817746893']
1528,31523039,"Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone.
METHODS


In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303.
FINDINGS


Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethasone group and 28 (4%) fetuses, infants, or children in the betamethasone group died before age 2 years. The primary outcome of death or neurosensory disability at age 2 years was determined for 603 (79%) of 763 fetuses whose mothers received dexamethasone and 591 (79%) of 746 fetuses whose mothers received betamethasone. We found a similar incidence of death or neurosensory disability in the dexamethasone (198 [33%] of 603 infants) and betamethasone groups (192 [32%] of 591 infants; adjusted relative risk [adjRR] 0·97, 95% CI 0·83 to 1·13; p=0·66). 18 (3%) of 679 women in the dexamethasone group and 28 of 667 (4%) women in the betamethasone group reported side-effects. Discomfort at the injection site, the most frequent side-effect, was less likely in the dexamethasone group than in the betamethasone group (six [1%] women vs 17 [3%] women; p=0·02).
INTERPRETATION


The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment. Our findings indicate that either antenatal corticosteroid can be given to women before preterm birth to improve infant and child health.
FUNDING


National Health and Medical Research Council (Australia).",2019,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"['recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies', 'Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids', 'Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50', 'and 667 (50%) women']","['antenatal corticosteroid', 'dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose', 'betamethasone', 'Maternal intramuscular dexamethasone', 'dexamethasone', 'antenatal dexamethasone']","['death or neurosensory disability', 'side-effects', 'incidence of survival without neurosensory disability', 'Discomfort', 'death or neurosensory disability at age 2 years (corrected for prematurity', 'risk of death or neurosensory disability', 'neonatal morbidity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0108964', 'cui_str': 'Celestone Chronodose'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",679.0,0.56823,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand; School of Medicine, The University of Adelaide, Adelaide, SA, Australia. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Chad C', 'Initials': 'CC', 'LastName': 'Andersen', 'Affiliation': ""Department of Perinatal Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Philippa F', 'Initials': 'PF', 'LastName': 'Middleton', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Osteoporosis and Bone Biology, Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Department of Obstetrics and Gynaecology, The Royal Women's Hospital and Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Robinson', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30292-5']
1529,29140138,COX-2 expression and effects of celecoxib in addition to standard chemotherapy in advanced non-small cell lung cancer.,"AIM


Inhibition of cyclooxygenase-2 (COX-2) is proposed as a treatment option in several cancer types. However, in non-small cell lung cancer (NSCLC), phase III trials have failed to demonstrate a benefit of adding COX-2 inhibitors to standard chemotherapy. The aim of this study was to analyze COX-2 expression in tumor and stromal cells as predictive biomarker for COX-2 inhibition.
METHODS


In a multicenter phase III trial, 316 patients with advanced NSCLC were randomized to receive celecoxib (400 mg b.i.d.) or placebo up to one year in addition to a two-drug platinum-based chemotherapy combination. In a subset of 122 patients, archived tumor tissue was available for immunohistochemical analysis of COX-2 expression in tumor and stromal cells. For each compartment, COX-2 expression was graded as high or low, based on a product score of extension and intensity of positively stained cells.
RESULTS


An updated analysis of all 316 patients included in the original trial, and of the 122 patients with available tumor tissue, showed no survival differences between the celecoxib and placebo arms (HR 1.01; 95% CI 0.81-1.27 and HR 1.12; 95% CI 0.78-1.61, respectively). High COX-2 scores in tumor (n = 71) or stromal cells (n = 55) was not associated with a superior survival outcome with celecoxib vs. placebo (HR =0.96, 95% CI 0.60-1.54; and HR =1.51; 95% CI 0.86-2.66), and no significant interaction effect between COX-2 score in tumor or stromal cells and celecoxib effect on survival was detected (p = .48 and .25, respectively).
CONCLUSIONS


In this subgroup analysis of patients with advanced NSCLC treated within the context of a randomized trial, we could not detect any interaction effect of COX-2 expression in tumor or stromal cells and the outcome of celecoxib treatment in addition to standard chemotherapy.",2018,"High COX-2 scores in tumor (n = 71) or stromal cells (n = 55) was not associated with a superior survival outcome with celecoxib vs. placebo (HR =0.96, 95% CI 0.60-1.54; and HR =1.51; 95% CI 0.86-2.66), and no significant interaction effect between COX-2 score in tumor or stromal cells and celecoxib effect on survival was detected (p = .48 and .25, respectively).
","['316 patients with advanced NSCLC', 'advanced non-small cell lung cancer', '316 patients included in the original trial, and of the 122 patients with available tumor tissue']","['celecoxib vs. placebo', 'platinum-based chemotherapy combination', 'placebo', 'celecoxib', 'standard chemotherapy', 'celecoxib and placebo', 'cyclooxygenase-2 (COX-2']","['High COX-2 scores', 'COX-2 expression', 'COX-2 score in tumor or stromal cells and celecoxib effect on survival', 'survival differences', 'superior survival outcome', 'COX-2 expression and effects']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",316.0,0.536075,"High COX-2 scores in tumor (n = 71) or stromal cells (n = 55) was not associated with a superior survival outcome with celecoxib vs. placebo (HR =0.96, 95% CI 0.60-1.54; and HR =1.51; 95% CI 0.86-2.66), and no significant interaction effect between COX-2 score in tumor or stromal cells and celecoxib effect on survival was detected (p = .48 and .25, respectively).
","[{'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Gulyas', 'Affiliation': 'a Department of Immunology, Genetics and Pathology , Uppsala University , Uppsala , Sweden.'}, {'ForeName': 'Johanna Sofia Margareta', 'Initials': 'JSM', 'LastName': 'Mattsson', 'Affiliation': 'a Department of Immunology, Genetics and Pathology , Uppsala University , Uppsala , Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'b Department of Clinical and Experimental Medicine, Faculty of Health Sciences , Linkoping University, Allergy Centre , Linkoping , Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ek', 'Affiliation': 'c Pulmonary Medicine , Skane University Hospital , Lund , Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lamberg Lundström', 'Affiliation': 'd Pulmonary Medicine , Akademiska Hospital , Uppsala , Sweden.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Behndig', 'Affiliation': 'e Pulmonary Medicine , Norrland University Hospital , Umeå , Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'f Department of Oncology , Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg , Gothenburg , Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Micke', 'Affiliation': 'a Department of Immunology, Genetics and Pathology , Uppsala University , Uppsala , Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'g Department of Respiratory Medicine , Institute of medicine, Sahlgrenska Academy at University of Gothenburg , Gothenburg , Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2017.1400685']
1530,31337525,Design and rationale of the STroke secondary prevention with catheter ABLation and EDoxaban clinical trial in patients with non-valvular atrial fibrillation: The STABLED study.,"BACKGROUND


Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies. However, the risks and benefits of CA have not been well elucidated in patients with NVAF and who have suffered a recent ischemic stroke in prospective randomized trials. Thus, the aim of the STABLED clinical trial is to investigate the efficacy and safety of CA with anticoagulant therapy using edoxaban in patients with NVAF and a history of recent ischemic stroke.
METHODS AND DESIGN


The STABLED trial is a multicenter, prospective, randomized, open-label, standard medication-controlled study in Japan. The target patient number is 250, comprising 125 patients receiving standard medication and 125 receiving CA. For patients allocated to the CA group, ablation is to be performed between 1 to 6 months from the onset of index stroke. The observation period will be 3 years from the day of random allocation of the final patient to any of the groups. The primary outcome measure is the composite of recurrence of ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure.
CONCLUSION


This study will investigate the effectiveness and safety of CA and basic anticoagulation treatment with edoxaban for patients with NVAF who have suffered a recent ischemic stroke. The aim is to determine the best evidence for an optimal treatment strategy for patients with NVAF and recent stroke.
TRIAL REGISTRATION


UMIN000031424/NCT03777631.",2019,"The primary outcome measure is the composite of recurrence of ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure.
","['patients with NVAF and who have suffered a recent ischemic stroke', 'Japan', 'patients with NVAF who have suffered a recent ischemic stroke', 'patients with NVAF and a history of recent ischemic stroke', 'patients with NVAF and recent stroke', '125 patients receiving standard medication and 125 receiving CA', 'patients with nonvalvular atrial fibrillation (NVAF', 'patients with non-valvular atrial fibrillation']","['catheter ABLation and EDoxaban', 'CA', 'Catheter ablation (CA', 'edoxaban']","['composite of recurrence of ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",125.0,0.0923911,"The primary outcome measure is the composite of recurrence of ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure.
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Neurological Science, Nippon Medical School, Tokyo, Japan. Electronic address: yuki-sakamoto@nms.ac.jp.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Neurological Science, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yu-Ki', 'Initials': 'YK', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Department of Cardiovascular Center, Saiseikai Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'Division of Neurology, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan; Center for Clinical Research, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Iguchi', 'Affiliation': 'Department of Neurology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kanamaru', 'Affiliation': 'Department of Neurological Science, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Jumpei', 'Initials': 'J', 'LastName': 'Kaburagi', 'Affiliation': 'Department of Medical Science, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Medical Science, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takuyuki', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Safety and Risk Management Department, Daiichi Sankyo Co., Tokyo, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurological Science, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.06.002']
1531,29168962,Assessment of anxiety in adolescents involved in a study abroad program: a prospective study.,"Objective The aim of the study was to measure the effects on levels of anxiety in healthy teenagers caused by a temporary change of country and school during a study abroad program. Methods In a prospective study we gathered the data from six anxiety level related tests on high school participants in a study abroad program (age 15-17, n = 364, M 172, F 192). These volunteer participants were divided into two separate groups: with self-reported elevated levels of anxiety (n = 111; YES-group) and with self-reported normal levels of anxiety (n = 253; NO-group). Two control groups of schoolchildren drawn from two local schools were used for comparison (n = 100 each). Three tests were subjective, i.e. self-fill-out tests. The next three tests were objective psychological or neurophysiological tests designed to estimate reflex control, concentration and a feeling for the passage of time. Results The initial mean anxiety level score among the 364 participants was 41.5 ± 16.7 (min 16, max 80) on 5-110 scale. For the YES-group the score was 56.5 ± 15.9, and for the NO-group the score was 34.7 ± 17.4 (p = 0.05). The retesting after they had been in the same place for 7 weeks revealed that the mean anxiety level score of the participants decreased to 37.4 ± 16.9 (min 15, max 72). For the YES-group the score significantly decreased to 39.3 ± 15.5, and for the NO-group the score slightly elevated to 36.7 ± 16.4 producing similar results for both groups (p = 0.81). Conclusion A temporary change of country and school at first results in a rise in anxiety levels in about one third of participants. However, after an extended stay it falls to normal levels.",2017,"For the YES-group the score significantly decreased to 39.3 ± 15.5, and for the NO-group the score slightly elevated to 36.7 ± 16.4 producing similar results for both groups (p = 0.81).","['high school participants in a study abroad program (age 15-17, n = 364, M 172, F 192', 'Two control groups of schoolchildren drawn from two local schools were used for comparison (n = 100 each', 'healthy teenagers']",[],"['elevated levels of anxiety', 'initial mean anxiety level score', 'anxiety levels', 'mean anxiety level score']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]",[],"[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",364.0,0.0168308,"For the YES-group the score significantly decreased to 39.3 ± 15.5, and for the NO-group the score slightly elevated to 36.7 ± 16.4 producing similar results for both groups (p = 0.81).","[{'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Roitblat', 'Affiliation': 'Department of Sciences, Yohana Jabotinsky Youth Town for Sciences and Arts Six Year Comprehensive School, Beer Yakov, Israel.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Cleminson', 'Affiliation': 'Department of Psychology, Mount Moriah College, Sydney, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Kavin', 'Affiliation': 'Department of Psychology, Mount Moriah College, Sydney, Australia.'}, {'ForeName': 'Edan', 'Initials': 'E', 'LastName': 'Schonberger', 'Affiliation': 'Department of Psychology, Mount Moriah College, Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shterenshis', 'Affiliation': 'Department of Sciences, Alexander Muss High School in Israel (AMHSI) affiliated to Alexander Muss Institute for Israel Education (AMIIE), Hod HaSharon, Israel.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2017-0101']
1532,29139311,Baseline sleep quality is a significant predictor of quit-day smoking self-efficacy among low-income treatment-seeking smokers.,"Compared to non-smokers, smokers have an increased risk for poor sleep quality, which could undermine confidence to quit. This study examined whether baseline sleep quality was associated with quit-day smoking self-efficacy among smokers enrolled in a smoking cessation trial. Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only. Poor sleep quality was significantly associated with lower quit-day (week 4) smoking self-efficacy ( β  = -0.61; standard error = 8.1;  p  = .03). Over half the samples (53%) reported poor sleep quality, thus addressing baseline sleep quality is an important consideration in smoking cessation programs.",2019,Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only.,"['Treatment-seeking low-income smokers', 'smokers enrolled in a smoking cessation trial']",['low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only'],"['baseline sleep quality', 'Baseline sleep quality', 'quit-day smoking self-efficacy', 'poor sleep quality', 'Poor sleep quality']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}]",,0.00906873,Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only.,"[{'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Nair', 'Affiliation': '1 Department of Health Promotion Sciences, The University of Arizona, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Haynes', 'Affiliation': '1 Department of Health Promotion Sciences, The University of Arizona, USA.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': '2 College of Public Health, Temple University, USA.'}]",Journal of health psychology,['10.1177/1359105317740619']
1533,29254398,"Impact of Latin Dance on Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior Among Latinos Attending an Adult Day Center.","Objective:  The aim of this study was to determine whether a Latin dance program with sedentary behavior information would have an impact on physical activity, cardiorespiratory fitness (CRF), and sedentary behavior among older Latinos attending an adult day center (ADC).  Method : Participants ( N  = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8) were randomized into a dance or wait-list control group. Participants wore an accelerometer and inclinometer and completed a sedentary behavior questionnaire, and a nonexercise equation was used to calculate CRF.  Results : Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.  Discussion : Future studies may consider implementing behavioral strategies during midpoint of the intervention to encourage participants attending an ADC to maintain physical activity and sedentary behavior changes.",2019,"RESULTS


Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.
","['older Latinos attending an adult day center (ADC', 'Latinos Attending an Adult Day Center', 'Participants ( N = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8']",['dance or wait-list control group'],"['physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior', 'Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior', 'physical activity, cardiorespiratory fitness (CRF), and sedentary behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0297971,"RESULTS


Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Aguiñaga', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago, USA.'}]",Journal of aging and health,['10.1177/0898264317733206']
1534,31628524,Metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer: a prospective open-label pilot trial.,"PURPOSE


To evaluate the efficacy of metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer.
METHODS


Epithelial ovarian cancer patients without diabetes mellitus were allocated to non-metformin group (paclitaxel plus carboplatin) or metformin group (paclitaxel plus carboplatin plus metformin). The primary endpoint was progression-free survival (PFS) and disease-free survival (DFS).
RESULTS


A total of 20 patients were assigned to metformin group and 24 patients to non-metformin group. The baseline information in two groups had no significant difference. The PFS and DFS of patients with metformin intake versus without metformin intake was 23 versus 21 months (p = 0.68) and 29 versus 26 months (p = 0.61), respectively. The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively. Metformin effectively inhibited the increase of IGF-1 and maintained the IGFBP-1.
CONCLUSIONS


Within the limitations of the small sample size, there was no evidence of meaningful effect on PFS by metformin even though evidence of modulation of IGF-1 signaling axis was apparent.",2019,"The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively.","['Epithelial ovarian cancer patients without diabetes mellitus', 'epithelial ovarian cancer', 'group and 24 patients to non-metformin group', '20 patients']","['Metformin', 'metformin group (paclitaxel plus carboplatin) or metformin group (paclitaxel plus carboplatin plus metformin', 'metformin', 'metformin plus first-line chemotherapy versus chemotherapy alone', 'Metformin plus first-line chemotherapy versus chemotherapy alone']","['IGF-1', 'progression-free survival (PFS) and disease-free survival (DFS']","[{'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.0241352,"The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China. hongsun57@hotmail.com.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03963-7']
1535,29243519,Changes in behavioral outcomes among children affected by HIV: Results of a randomized controlled trial in China.,"This study assessed the effects of a multilevel intervention on HIV-affected children's negative behaviors. A total of 536 children aged 6-18 years from 475 HIV-affected families in Anhui, China, participated in the randomized controlled trial. A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up. The intervention showed greater effects for children aged 13-18 years than those aged 6-12 years. Study findings suggest that a multilevel intervention approach could be beneficial for reducing negative behavior in HIV-affected children. Age-specific programs should be considered to maximize the intervention effects.",2019,"A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up.","[""HIV-affected children's negative behaviors"", 'HIV-affected children', '536 children aged 6-18\u2009years from 475 HIV-affected families in Anhui, China', 'children affected by HIV', 'children aged 13-18\u2009years than those aged 6-12\u2009years']",['multilevel intervention'],"['negative behavior', 'negative behaviors', 'behavioral outcomes']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",536.0,0.134172,"A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Liang', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Chiao-Wen', 'Initials': 'CW', 'LastName': 'Lan', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': '2 Anhui Provincial Center for Woman and Child Health, China.'}, {'ForeName': 'Yongkang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': '3 Anhui Provincial Center for Disease Control and Prevention, China.'}]",Journal of health psychology,['10.1177/1359105317746479']
1536,29262693,A Randomized Controlled Trial of Multiple Versions of an Acceptance and Commitment Therapy Matrix App for Well-Being.,"Mobile apps may be useful in teaching psychological skills in a high-frequency, low-intensity intervention. The acceptance and commitment therapy (ACT) matrix is a visual tool to help develop psychological flexibility by categorizing moment-to-moment experience and is well suited to a mobile app. This pilot study tested the effects of a simple and complex version of a novel app using the ACT matrix in two distinct samples: help-seeking individuals ( n  = 35) and students receiving SONA credit ( n  = 63). Findings indicated no differences between app conditions and a waitlist condition in the SONA credit sample. However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills. A mobile app based on the ACT matrix has benefits for help-seeking individuals, but supplementary features may be necessary to support consistent use and benefits.",2019,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.",['two distinct samples: help-seeking individuals ( n = 35) and students receiving SONA credit ( n = 63'],"['simple and complex version of a novel app using the ACT matrix', 'ACT matrix']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]",[],63.0,0.0482813,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potts', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schoendorff', 'Affiliation': 'Contextual Psychology Institute, Mont-Saint-Hilaire, Quebec, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Logan, UT, USA.'}]",Behavior modification,['10.1177/0145445517748561']
1537,31605608,"Erratum to: SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial.",,2020,,"['1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}]",[],[],,0.0355185,,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz931']
1538,30541065,Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial.,"BACKGROUND


Low-grade chronic inflammation, characterized by elevations in plasma Interleukin-6 (IL-6), is an independent risk factor of impaired mobility in older persons. Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3) may reduce IL-6 and may potentially improve physical function. To assess the main effects of the angiotensin receptor blocker losartan and ω-3 as fish oil on IL-6 and 400 m walking speed, we conducted the ENRGISE Pilot multicenter randomized clinical trial.
METHODS


The ENRGISE Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months. Participants were aged ≥70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/mL, and were able to walk 400 m at baseline. Participants were randomized in three strata 2 × 2 factorial to: (i) losartan 50-100 mg/d or placebo (n = 43), (ii) fish oil 1,400-2,800 mg/d or placebo (n = 180), and (iii) with both (n = 66).
RESULTS


Two hundred eighty-nine participants were randomized (mean age 78.3 years, 47.4% women, 17.0% black). There was no effect of losartan (difference of means = -0.065 ± 0.116 [SE], 95% confidence interval [CI]: -0.293-0.163, p = .58) or fish oil (-0.020 ± 0.077, 95% CI: -0.171-0.132, p = .80) on the log of IL-6. Similarly, there was no effect of losartan (-0.025 ± 0.026, 95% CI: -0.076-0.026, p = .34) or fish oil (0.010 ± 0.017, 95% CI: -0.025-0.044, p = .58) on walking speed (m/s).
CONCLUSIONS


These results do not support the use of these interventions to prevent mobility loss in older adults at risk of disability with low-grade chronic inflammation.
REGISTRATION


Clinicaltrials.gov NCT02676466.",2019,"There was no effect of losartan (difference of means=-0.065±0.116 [SE], 95% CI: -0.293 to 0.163, P=0.58) or fish oil (","['older adults at risk of disability with low-grade chronic inflammation', 'Participants were aged >=70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/ml, and were able to walk 400 meters at baseline', 'older persons', '289 participants were randomized (mean ag/e 78.3 years, 47.4% women, 17.0% black', 'Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months']","['losartan and fish oil', 'losartan', 'Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3', 'losartan 50 to 100 mg/day or placebo', 'angiotensin receptor blocker losartan', 'fish oil ', 'fish oil 1400 to 2800 mg/day or placebo']","['plasma IL-6 and mobility', 'log of IL-6', 'mobility loss']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C4517680', 'cui_str': 'Two thousand eight hundred'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",289.0,0.700689,"There was no effect of losartan (difference of means=-0.065±0.116 [SE], 95% CI: -0.293 to 0.163, P=0.58) or fish oil (","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Kristina H', 'Initials': 'KH', 'LastName': 'Lewis', 'Affiliation': 'Departments of Epidemiology & Prevention, and Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Liu', 'Affiliation': 'Section of Geriatrics, Department of Medicine, Boston University School of Medicine, Massachusetts.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Radziszewska', 'Affiliation': 'Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, Maryland.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Stowe', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Departments of Pathology & Laboratory Medicine, and Biochemistry, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly277']
1539,31603428,Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study.,"BACKGROUND


In a clinical trial, internet-based cognitive behavioral therapy (I-CBT) embedded in stepped care was established as noninferior to face-to-face cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS). However, treatment effects observed in clinical trials may not necessarily be retained after implementation.
OBJECTIVE


This study aimed to investigate whether stepped care for CFS starting with I-CBT, followed by face-to-face CBT, if needed, was also effective in routine clinical care. Another objective was to explore the role of therapists' attitudes toward electronic health (eHealth) and manualized treatment on treatment outcome.
METHODS


I-CBT was implemented in five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands. All patients with CFS were offered I-CBT, followed by face-to-face CBT if still severely fatigued or disabled after I-CBT. Outcomes were the Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale. The change scores (pre to post stepped care) were compared with a benchmark: stepped care from a randomized controlled trial (RCT) testing this treatment format. We calculated correlations of therapists' attitudes toward manualized treatment and eHealth with reduction of fatigue severity.
RESULTS


Overall, 100 CFS patients were referred to the centers. Of them, 79 started with I-CBT, 20 commenced directly with face-to-face CBT, and one did not start at all. After I-CBT, 48 patients met step-up criteria; of them, 11 stepped up to face-to-face CBT. Increase in physical functioning (score of 13.4), social functioning (20.4), and reduction of limitations (10.3) after stepped care delivered in routine clinical care fell within the benchmarks of the RCT (95% CIs: 12.8-17.6; 25.2-7.8; and 7.4-9.8, respectively). Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT (95% CI 13.2-16.5). After I-CBT only, reduction of fatigue severity (13.2) fell within the benchmark of I-CBT alone (95% CI 11.1-14.2). Twenty therapists treated between one and 18 patients. Therapists were divided into two groups: one with the largest median reduction of fatigue and one with the smallest. Patients treated by the first group had a significantly larger reduction of fatigue severity (15.7 vs 9.0; t=2.42; P=.02). There were no (statistically significant) correlations between therapists' attitudes and reduction in fatigue.
CONCLUSIONS


This study is one of the first to evaluate stepped care with I-CBT as a first step in routine clinical care. Although fatigue severity and disabilities were reduced, reduction of fatigue severity appeared smaller than in the clinical trial. Further development of the treatment should aim at avoiding dropout and encouraging stepping up after I-CBT with limited results. Median reduction of fatigue severity varied largely between therapists. Further research will help understand the role of therapists' attitudes in treatment outcome.",2019,Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT,"['100 CFS patients were referred to the centers', 'All patients with CFS', 'five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands', 'Twenty therapists treated between one and 18 patients']","['Internet-Based Cognitive Behavioral Therapy', 'RCT', 'cognitive behavioral therapy (CBT', 'internet-based cognitive behavioral therapy (I-CBT']","['Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale', 'Reduction of fatigue severity', 'fatigue severity', 'Median reduction of fatigue severity', 'physical functioning (score of 13.4), social functioning', 'reduction of fatigue severity', 'fatigue severity and disabilities', 'fatigue']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",20.0,0.0346078,Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT,"[{'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Worm-Smeitink', 'Affiliation': 'Expert Center for Chronic Fatigue, Department of Medical Psychology, University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'van Dam', 'Affiliation': 'Tranzo, School of Social and Behavioural Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'van Es', 'Affiliation': 'PsyQ Somatiek en Psyche, Parnassia Groep, Amsterdam, Netherlands.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'van der Vaart', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Expert Center for Chronic Fatigue, Department of Medical Psychology, University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14037']
1540,31522546,"Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.","INTRODUCTION


Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data.
METHODS


This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart).
RESULTS


Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) ( p  = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53;  p  = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common.
CONCLUSIONS


Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The ""sham"" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients.  Study identification and registration:  PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.",2019,"Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days)","['477 enrolled patients', 'patients with migraine', 'episodic migraine']","['invasive vagus nerve stimulation (nVNS', 'nVNS', 'Non-invasive vagus nerve stimulation (nVNS; gammaCore®']","['therapeutic gains', 'episodic migraine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]",477.0,0.392219,"Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days)","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Faculty of Medicine, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sinclair', 'Affiliation': 'Metabolic Neurology, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Dimos', 'Initials': 'D', 'LastName': 'Mitsikostas', 'Affiliation': '1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Magis', 'Affiliation': 'Neurology Department and Pain Clinic, CHR East Belgium, Liège, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pozo-Rosich', 'Affiliation': ""Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Irimia Sieira', 'Affiliation': 'Clinica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel Ja', 'Initials': 'MJ', 'LastName': 'Làinez', 'Affiliation': 'Catholic University of Valencia, University Clinic Hospital, Valencia, Spain.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Königstein, Germany.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silver', 'Affiliation': 'The Walton Centre, Liverpool, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Marin', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419876920']
1541,31592824,Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.,"BACKGROUND


Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis.
OBJECTIVE


Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH).
METHODS


This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs.
RESULTS


At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss.
CONCLUSION


Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03612570.",2020,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","['Sebaceous Gland Hyperplasia', '72 subjects resulting in a total of 222 treated lesions']","['nsPEF', 'Nanosecond Pulsed Electric Field Treatment', 'local anesthetic, high-intensity, ultrashort pulses of electrical energy']","['tolerability and effectiveness', 'Safety and Efficacy']","[{'cui': 'C0406484', 'cui_str': 'Sebaceous hyperplasia (disorder)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0337037', 'cui_str': 'Electric field (physical force)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.0271499,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","[{'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Munavalli', 'Affiliation': 'Laser & Vein Specialists, Charlotte, North Carolina.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Zelickson', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Selim', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Kilmer', 'Affiliation': 'Laser & Skin Surgery Center of Northern California, Sacramento, California.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohrer', 'Affiliation': 'Skin Care Physicians, Chestnut, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': 'Premier Plastic Surgery, San Mateo, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jauregui', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Knape', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ebbers', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Darrin', 'Initials': 'D', 'LastName': 'Uecker', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nuccitelli', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002154']
1542,31593582,"Biopsying, fragmentation and autotransplantation of fresh ovarian cortical tissue in infertile women with diminished ovarian reserve.","STUDY QUESTION


Can ovarian biopsying per se and/or autotransplantation of fragmented ovarian cortical tissue activate dormant follicles and increase the number of recruitable follicles for IVF/ICSI in women with diminished ovarian reserve (DOR)?
SUMMARY ANSWER


Ovarian biopsying followed by immediate autotransplantation of fragmented cortical tissue failed to increase the number of recruitable follicles for IVF/ICSI 10 weeks after the procedure either at the graft site or in the biopsied ovary, but 12 of the 20 women subsequently had a clinical pregnancy during the 1-year follow-up.
WHAT IS KNOWN ALREADY


Infertile women with DOR constitute a group of patients with poor reproductive outcome mainly due to the low number of mature oocytes available for IVF/ICSI. Recent studies have shown that in vitro activation of residual dormant follicles by both chemical treatment and tissue fragmentation has resulted in return of menstrual cycles and pregnancies in a fraction of amenorrhoeic women with premature ovarian insufficiency.
STUDY DESIGN, SIZE, DURATION


This is a prospective clinical cohort study including 20 women with DOR treated at the fertility clinic, Rigshospitalet, Denmark, during April 2016-December 2017. Non-pregnant patients were on average followed for 280 days (range 118-408), while women who conceived were followed until delivery. Study follow-up of non-pregnant patients ended in September 2018.
PARTICIPANTS, MATERIALS, SETTING, METHODS


The study included infertile women aged 30-39 years with preserved menstrual cycles, indication for IVF/ICSI and repeated serum measurements of anti-Müllerian hormone (AMH) ≤ 5 pmol/L. Patients were randomized to have four biopsies taken from either the left or the right ovary by laparoscopy followed by fragmentation of the cortical tissue to an approximate size of 1 mm3 and autotransplanted to a peritoneal pocket. The other ovary served as a control. Patients were followed weekly for 10 weeks with recording of hormone profile, antral follicle count (AFC), ovarian volume and assessment for ectopic follicle growth. After 10 weeks, an IVF/ICSI-cycle with maximal ovarian stimulation was initiated.
MAIN RESULTS AND THE ROLE OF CHANCE


No difference in the number of mature follicles after ovarian stimulation 10 weeks after the procedure in the biopsied versus the control ovaries was observed (1.0 vs. 0.7 follicles, P = 0.35). In only three patients, growth of four follicles was detected at the graft site 24-268 days after the procedure. From one of these follicles, a metaphase II (MII) oocyte was retrieved and fertilized, but embryonic development failed. Overall AMH levels did not change significantly after the procedure (P = 0.2). The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01). Serum levels of androstenedione and testosterone increased significantly by 0.63 nmol/L (95% CI: 0.21;1.04) and 0.11 nmol/L (95% CI: 0.01;0.21) 1 week after the procedure, respectively, and testosterone increased consecutively over the 10 weeks by 0.0095 nmol/L (95% CI: 0.0002;0.0188) per week (P = 0.045). In 7 of the 20 patients, there was a serum AMH elevation 5 to 8 weeks after the procedure. In this group, mean AMH increased from 2.08 pmol/L (range 1.74-2.34) to 3.94 pmol/L (range 3.66-4.29) from Weeks 1-4 to Weeks 5-8. A clinical pregnancy was obtained in 12 of the 20 (60%) patients with and without medically assisted reproduction (MAR) treatments. We report a cumulated live birth rate per started IVF/ICSI cycle of 18.4%.
LIMITATIONS, REASON FOR CAUTION


Limitations of the study were the number of patients included and the lack of a non-operated control group. Moreover, 9 of the 20 women had no male partner at inclusion and were treated with donor sperm, but each of these women had an average of 6.8 (range 4-9) unsuccessful MAR treatments with donor sperm prior to inclusion.
WIDER IMPLICATIONS OF THE FINDINGS


Although 12 out of 20 patients became pregnant during the follow-up period, the current study does not indicate that biopsying, fragmenting and autotransplanting of ovarian cortical tissue increase the number of recruitable follicles for IVF/ICSI after 10 weeks. However, a proportion of the patients may have a follicular response in Weeks 5-8 after the procedure. It could therefore be relevant to perform a future study on the possible effects of biopsying per se that includes stimulation for IVF/ICSI earlier than week 10.
STUDY FUNDING/COMPETING INTEREST(S)


This study is part of the ReproUnion collaborative study, co-financed by the European Union, Interreg V ÖKS. The funders had no role in the study design, data collection and interpretation, or decision to submit the work for publication. None of the authors have a conflict of interest.
TRIAL REGISTRATION NUMBER


NCT02792569.",2019,"The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01).","['12 of the 20 (60%) patients with and without medically assisted reproduction (MAR) treatments', 'Infertile women with DOR', 'women with diminished ovarian reserve (DOR', '20 women with DOR treated at the fertility clinic, Rigshospitalet, Denmark, during April 2016-December 2017. Non-pregnant patients were on average followed for 280\xa0days (range 118-408), while women who conceived were followed until delivery', 'amenorrhoeic women with premature ovarian insufficiency', 'infertile women with diminished ovarian reserve', 'infertile women aged 30-39\xa0years with preserved menstrual cycles, indication for IVF/ICSI and repeated serum measurements of anti-Müllerian hormone (AMH)\u2009≤\u20095\xa0pmol/L. Patients', '20 women had no male partner at inclusion and were treated with donor sperm, but each of these women had an average of 6.8 (range 4-9) unsuccessful MAR treatments with donor sperm prior to inclusion', 'non-pregnant patients ended in September 2018']",['right ovary by laparoscopy followed by fragmentation of the cortical tissue to an approximate size of 1\xa0mm3 and autotransplanted to a peritoneal pocket'],"['clinical pregnancy', 'mean AMH', 'number of mature follicles', 'growth of four follicles', 'Overall AMH levels', 'cumulated live birth rate per started IVF/ICSI cycle', 'low number of mature oocytes available for IVF/ICSI', 'serum AMH elevation', 'Serum levels of androstenedione and testosterone', 'AFC', 'metaphase II (MII) oocyte', 'antral follicle count (AFC), ovarian volume and assessment for ectopic follicle growth', 'number of recruitable follicles for IVF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3839507', 'cui_str': 'Diminished ovarian reserve (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0430991', 'cui_str': 'Mixed antiglobulin test for sperm (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0227873', 'cui_str': 'Structure of right ovary'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}]",,0.159613,"The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01).","[{'ForeName': 'Stine Aagaard', 'Initials': 'SA', 'LastName': 'Lunding', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Elisabeth', 'Initials': 'SE', 'LastName': 'Pors', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Stine Gry', 'Initials': 'SG', 'LastName': 'Kristensen', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Selma Kloeve', 'Initials': 'SK', 'LastName': 'Landersoe', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Janni Vikkelsø', 'Initials': 'JV', 'LastName': 'Jeppesen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Esben Meulengracht', 'Initials': 'EM', 'LastName': 'Flachs', 'Affiliation': 'Department of Occupational and Environmental Medicine, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirsten Tryde', 'Initials': 'KT', 'LastName': 'Macklon', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anette Tønnes', 'Initials': 'AT', 'LastName': 'Pedersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus Yding', 'Initials': 'CY', 'LastName': 'Andersen', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders Nyboe', 'Initials': 'AN', 'LastName': 'Andersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez152']
1543,31018018,Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial.,"OBJECTIVE


To examine the effects of bilateral custom-made ankle-foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12-month daily use.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Community-dwelling older adults.
INTERVENTION


Half of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes.
MEASUREMENTS


Self-reported fall history of 12-month duration was investigated at baseline and 12-month follow-up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12-month footwear intervention in either group.
PARTICIPANTS


Adults aged 65 years and older with concern about or at risk for falling (n = 44).
RESULTS


No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12-month follow-up compared to the baseline. Within the CG, no significant change was found at the 12-month follow-up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12-month follow-up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080).
CONCLUSION


This study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011. J Am Geriatr Soc 67:1656-1661, 2019.",2019,No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882).,"['older adults with concern about or at risk for falling over 12-month daily use', 'Community-dwelling older adults', 'Adults aged 65\u2009years and older with concern about or at risk for falling (n\u2009=\u200944', 'Older Adults']","['bilateral custom-made ankle-foot orthoses (AFOs', 'intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes', 'Bilateral Custom-Made Ankle-Foot Orthoses']","['proportion of fallers', 'Self-reported fall history of 12-month duration', 'Fall incidence rate and proportion of fallers', 'fall incidence rate']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.055343,No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882).,"[{'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Interdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Goel', 'Affiliation': 'Interdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Qianzi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lepow', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Interdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15929']
1544,31774400,Medical Students' Experiences and Outcomes Using a Virtual Human Simulation to Improve Communication Skills: Mixed Methods Study.,"BACKGROUND


Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)-based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial.
OBJECTIVE


This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication.
METHODS


We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures-MPathic-VR-calculated scores and the objective structured clinical exam (OSCE) scores-with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis.
RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers.
CONCLUSIONS


VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.",2019,"RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01).",['Students at 3 medical schools in the United States (n=206) received'],"['virtual human (VH)-based simulation, MPathic-VR', 'VH-based simulation', 'simulation to improve empathic communication skills', 'Virtual Human Simulation']",['OSCE scores'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.104251,"RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01).","[{'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Guetterman', 'Affiliation': 'Creighton University, Omaha, NE, United States.'}, {'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Sakakibara', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srikar', 'Initials': 'S', 'LastName': 'Baireddy', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Kron', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Scerbo', 'Affiliation': 'Old Dominion University, Norfolk, VA, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cleary', 'Affiliation': 'Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Fetters', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}]",Journal of medical Internet research,['10.2196/15459']
1545,29654506,Evaluating the Training of Chinese-Speaking Community Health Workers to Implement a Small-Group Intervention Promoting Mammography.,"This study evaluated the training of Chinese American Community Health Workers (CHWs) to implement a small-group mammography video and discussion program as part of a randomized controlled trial that had the goal to increase adherence to mammography screening guidelines among Chinese American women. A total of 26 Chinese American CHWs in the metropolitan Washington DC area, Southern California, and New York City participated in a 4-h training workshop and completed surveys before and after the workshop to assess their knowledge regarding mammography screening guidelines and human subjects protection rules. The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training. CHWs were also trained to lead a discussion of the video, including screening benefits and misconceptions. Forty-three audio recordings of discussions led by 13 active CHWs were transcribed and qualitatively analyzed to assess implementation fidelity. Ten out of 13 active CHWs fully addressed about 3 of the 5 benefit items, and 11 out of 13 CHWs fully addressed more than 5 of the 9 misconception items. Chinese CHWs can be trained to implement research-based intervention programs. However, a one-time training resulted in moderate adherence to the discussion protocol. Ongoing or repeat trainings throughout the intervention period may be needed to enhance implementation fidelity.",2019,The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training.,"['Chinese American women', 'Chinese American Community Health Workers (CHWs', '26 Chinese American CHWs in the metropolitan Washington DC area, Southern California, and New York City']",['small-group mammography video and discussion program'],"['moderate adherence', 'knowledge of mammography screening guidelines and human subjects protection rules']","[{'cui': 'C0008121', 'cui_str': 'Chinese Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]",43.0,0.0191563,The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training.,"[{'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Maxwell', 'Affiliation': 'Fielding School of Public Health and Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Xiaokun', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Hsing-Chuan', 'Initials': 'HC', 'LastName': 'Hsieh', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Shin-Ping', 'Initials': 'SP', 'LastName': 'Tu', 'Affiliation': 'Division of General Internal Medicine, Geriatrics, and Bioethics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Judy Huei-Yu', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA. jw235@georgetown.edu.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1361-5']
1546,29948924,Social Media as a Tool to Promote Health Awareness: Results from an Online Cervical Cancer Prevention Study.,"Online social media platforms represent a promising opportunity for public health promotion. Research is limited, however, on the effectiveness of social media at improving knowledge and awareness of health topics and motivating healthy behavior change. Therefore, we investigated whether participation in an online social media platform and receipt of brief, tailored messages is effective at increasing knowledge, awareness, and prevention behaviors related to human papillomavirus (HPV) and cervical cancer. We conducted an online study in which 782 recruited participants were consecutively assigned to nine-person groups on a social media platform. Participants were shown a unique random set of 20 tailored messages per day over five days. Participants completed a baseline and post survey to assess their knowledge, awareness, and prevention behaviors related to HPV and cervical cancer. There were no statistically significant changes in knowledge and prevention behaviors from the baseline to the post survey among study participants. There was a modest, statistically significant change in response to whether participants had ever heard of HPV, increasing from 90 to 94% (p = 0.003). Our findings suggest that most study participants had substantial knowledge, awareness, and engagement in positive behaviors related to cervical cancer prevention at the start of the study. Nevertheless, we found that HPV awareness can be increased through brief participation in an online social media platform and receipt of tailored health messages. Further investigation that explores how social media can be used to improve knowledge and adoption of healthy behaviors related to cervical cancer is warranted.",2019,There were no statistically significant changes in knowledge and prevention behaviors from the baseline to the post survey among study participants.,"['Health Awareness', '782 recruited participants were consecutively assigned to nine-person groups on a']",['social media platform'],"['knowledge and prevention behaviors', 'knowledge, awareness, and prevention behaviors related to HPV and cervical cancer']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]",782.0,0.022272,There were no statistically significant changes in knowledge and prevention behaviors from the baseline to the post survey among study participants.,"[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Lyson', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA. helena.lyson@ucsf.edu.'}, {'ForeName': 'Gem M', 'Initials': 'GM', 'LastName': 'Le', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Communication, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rivadeneira', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lyles', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Radcliffe', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Pasick', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sawaya', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'Center for Vulnerable Populations, Division of General Internal Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Centola', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1379-8']
1547,31766497,Effect of Structural Individual Low-FODMAP Dietary Advice vs. Brief Advice on a Commonly Recommended Diet on IBS Symptoms and Intestinal Gas Production.,"A low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet has been recommended for irritable bowel syndrome (IBS) patients. This study compared the efficacy of two types of dietary advice: (1) brief advice on a commonly recommended diet (BRD), and (2) structural individual low-FODMAP dietary advice (SILFD). Patients with moderate-to-severe IBS were randomized to BRD or SILFD groups. Gastrointestinal symptoms, 7-day food diaries, and post-prandial breath samples were evaluated. The SILFD included (1) identifying high-FODMAP items from the diary, (2) replacing high-FODMAP items with low-FODMAP ones by choosing from the provided menu. The BRD included reducing traditionally recognized foods that cause bloating/abdominal pain and avoidance of large meals. Responders were defined as those experiencing a ≥30% decrease in the average of daily worst abdominal pain/discomfort after 4 weeks. Sixty-two patients (47 F, age 51 ± 14 years), BRD ( n  = 32) or SILFD ( n  = 30), completed the studies. Eighteen (60%) patients in SILFD vs. 9 (28%) in the BRD group fulfilled responder criteria ( p  = 0.001). Global IBS symptom severity significantly improved and the number of high-FODMAP items consumed was significantly decreased after SILFD compared to BRD. Post-prandial hydrogen (H 2 ) breath production after SILFD was significantly lower than was seen after BRD ( p  < 0.001). SILFD was more effective than BRD. This advice method significantly reduced FODMAP intake, improved IBS symptoms, and lowered intestinal H 2  production.",2019,Post-prandial hydrogen (H 2 ) breath production after SILFD was significantly lower than was seen after BRD ( p  < 0.001).,"['irritable bowel syndrome (IBS) patients', 'Patients with moderate-to-severe IBS', 'Sixty-two patients (47 F, age 51 ± 14 years), BRD ( n  = 32) or SILFD ( n  = 30), completed the studies']","['Structural Individual Low-FODMAP Dietary Advice vs. Brief Advice', 'SILFD', 'dietary advice: (1) brief advice on a commonly recommended diet (BRD), and (2) structural individual low-FODMAP dietary advice (SILFD', 'oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet']","['Post-prandial hydrogen (H 2 ) breath production after SILFD', 'FODMAP intake, improved IBS symptoms', 'IBS Symptoms and Intestinal Gas Production', 'Gastrointestinal symptoms, 7-day food diaries, and post-prandial breath samples', 'average of daily worst abdominal pain/discomfort', 'Global IBS symptom severity']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0012611', 'cui_str': 'Disaccharides'}, {'cui': 'C0026492', 'cui_str': 'Simple Sugars'}, {'cui': 'C0071629', 'cui_str': 'polyol'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520912', 'cui_str': 'Intestinal gas (substance)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",62.0,0.0229664,Post-prandial hydrogen (H 2 ) breath production after SILFD was significantly lower than was seen after BRD ( p  < 0.001).,"[{'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Gastroenterology, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Akarawut', 'Initials': 'A', 'LastName': 'Juntrapirat', 'Affiliation': 'Division of Gastroenterology, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Narisorn', 'Initials': 'N', 'LastName': 'Lakananurak', 'Affiliation': 'Division of Clinical Nutrition, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Sutep', 'Initials': 'S', 'LastName': 'Gonlachanvit', 'Affiliation': 'Division of Gastroenterology, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand.'}]",Nutrients,['10.3390/nu11122856']
1548,28810420,The effects of power and stretch yoga on affect and salivary cortisol in women.,"Yoga practice is known to improve well-being and decrease stress. However, acute yoga is understudied. This study investigated the effects of two different types of yoga on affect and salivary cortisol levels in college women. Thirty-three women aged 18-30 years each completed 1-hour sessions of power yoga and stretch yoga. Measures of affect and salivary cortisol were assessed before, during, and after each session. Participants perceived power yoga to be more pleasurable and energizing. Salivary cortisol significantly decreased after both yoga sessions. Thus, even one session of yoga may be effective in improving affect and decreasing stress in college women.",2019,Salivary cortisol significantly decreased after both yoga sessions.,"['Thirty-three women aged 18-30\u2009years', 'college women', 'women']","['power yoga and stretch yoga', 'power and stretch yoga']","['Salivary cortisol', 'salivary cortisol levels', 'affect and salivary cortisol']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",33.0,0.0193079,Salivary cortisol significantly decreased after both yoga sessions.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Elon University, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Carberry', 'Affiliation': 'Elon University, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Evans', 'Affiliation': 'Elon University, USA.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Hall', 'Affiliation': 'Elon University, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Nepocatych', 'Affiliation': 'Elon University, USA.'}]",Journal of health psychology,['10.1177/1359105317694487']
1549,28810442,Evaluation of a web-based cognitive behavioral smoking cessation treatment for overweight/obese smokers.,"This pilot study tested the efficacy of an Internet-administered smoking cessation treatment for overweight/obese smokers. Participants were 54 community volunteers with overweight/obesity who were regular smokers. Treatment consisted of 12 weeks of nicotine replacement therapy and randomization to Internet-administered cognitive behavioral treatment or health education. In-person assessments of key outcomes occurred at baseline, post-treatment, and at 24-week follow-up. Cessation rates did not differ across the two treatments (25.9% vs 18.5%). Participants receiving cognitive behavioral treatment gained less weight when abstinent than those receiving the standard treatment. Larger studies are needed to replicate these findings.",2019,Cessation rates did not differ across the two treatments (25.9% vs 18.5%).,"['Participants were 54 community volunteers with overweight/obesity who were regular smokers', 'overweight/obese smokers']","['web-based cognitive behavioral smoking cessation treatment', 'Internet-administered smoking cessation treatment', 'cognitive behavioral treatment', 'nicotine replacement therapy and randomization to Internet-administered cognitive behavioral treatment or health education']",['Cessation rates'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018701'}]",[],54.0,0.0133806,Cessation rates did not differ across the two treatments (25.9% vs 18.5%).,"[{'ForeName': 'Marney A', 'Initials': 'MA', 'LastName': 'White', 'Affiliation': 'Department of Social and Behavioral Sciences, Yale School of Public Health, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Department of Psychiatry, Yale University School of Medicine, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Department of Psychiatry, Yale University School of Medicine, USA.'}]",Journal of health psychology,['10.1177/1359105317701560']
1550,28847853,Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.,"OBJECTIVES


Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer.
METHODS


Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview.
RESULTS


150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold.
CONCLUSION


Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.",2020,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","['150 women consented (75 per group); 10 undertook interviews', 'women following curative treatment for stage I-III gynaecological cancer', 'women with gynaecological cancer', 'Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre']","['HNA and care planning', 'Holistic needs assessment (HNA) and care planning']","['European Organisation for Research and Treatment of Cancer (EORTC', 'Health service utilisation and quality-adjusted life years (QALY', 'EORTC functional and symptom scales', 'Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary', 'cancer-specific quality of life']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0558005', 'cui_str': 'Needs Assessment'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",150.0,0.178407,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sandsund', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Towers', 'Affiliation': 'Lead Nurse Counsellor, Psychological Support Services, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Senior Statistician Research Data Management and Statistics Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tigue', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Amyn', 'Initials': 'A', 'LastName': 'Lalji', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': 'Gynaeoncology Unit, Clinical Services Division, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Doyle', 'Affiliation': 'Nurse Consultant in Living With and Beyond Cancer, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2016-001207']
1551,28810466,Mediation of an efficacious HIV risk reduction intervention for adolescents: A cluster-randomised controlled trial.,"The 'Cuidate' programme for adolescents in Spain has proven to be effective for promoting healthy sexuality ( N  = 626), but the mechanisms underlying its effects are unknown. This study aimed to identify mediators of the intervention's effects compared to a control group. Participants were students from five areas of Spain, who completed baseline, immediate-posttest, 12-month and 24-month follow-up assessments. Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms. The findings underscore the importance of targeting knowledge on HIV and sexually transmitted infections to promote condom use intention and consistent condom use.",2019,Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms.,"['Participants were students from five areas of Spain, who completed baseline, immediate-posttest, 12-month and 24-month follow-up assessments', 'adolescents']",['efficacious HIV risk reduction intervention'],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",[],,0.0631008,Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Espada', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Orgilés', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}]",Journal of health psychology,['10.1177/1359105317707256']
1552,28810425,Psychological and behavioral effects of obesity prevention campaigns.,"Public health campaigns are often used to prevent or reduce obesity. However, social psychological theory suggests these efforts might not be universally helpful and could potentially have detrimental consequences. This investigation explored the effects of obesity prevention campaigns. Participants were randomized to view either weight-focused or weight-neutral campaigns. Assessments at three time points (pre, post, and follow-up) examined the differences between groups in reactions to campaigns and changes in health behaviors and psychological outcomes. Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.",2019,"Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.",[],['weight-focused or weight-neutral campaigns'],"['health behaviors and psychological outcomes', 'negative perceptions of obesity']",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0018687'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0154223,"Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.","[{'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Simpson', 'Affiliation': 'Virginia Commonwealth University, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Griffin', 'Affiliation': 'Virginia Commonwealth University, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, USA.'}]",Journal of health psychology,['10.1177/1359105317693913']
1553,28826281,Patients' Perceptions of an Exercise Program Delivered Following Discharge From Hospital After Critical Illness (the Revive Trial).,"BACKGROUND


The REVIVE randomized controlled trial (RCT) investigated the effectiveness of an individually tailored (personalized) exercise program for patients discharged from hospital after critical illness. By including qualitative methods, we aimed to explore patients' perceptions of engaging in the exercise program.
METHODS


Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland. Patients allocated to the exercise intervention group were invited to participate in this qualitative study. Independent semistructured interviews were conducted at 6 months after randomization. Interviews were audio-recorded, transcribed, and content analysis used to explore themes arising from the data.
RESULTS


Of 30 patients allocated to the exercise group, 21 completed the interviews. Patients provided insight into the physical and mental sequelae they experienced following critical illness. There was a strong sense of patients' need for the exercise program and its importance for their recovery following discharge home. Key facilitators of the intervention included supervision, tailoring of the exercises to personal needs, and the exercise manual. Barriers included poor mental health, existing physical limitations, and lack of motivation. Patients' views of outcome measures in the REVIVE RCT varied. Many patients were unsure about what would be the best way of measuring how the program affected their health.
CONCLUSIONS


This qualitative study adds an important perspective on patients' attitude to an exercise intervention following recovery from critical illness, and provides insight into the potential facilitators and barriers to delivery of the program and how programs should be evolved for future trials.",2019,"RESULTS


Of 30 patients allocated to the exercise group","['30 patients allocated to the exercise group', 'patients discharged from hospital after critical illness', 'Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland']","['Exercise Program Delivered Following Discharge From Hospital', 'exercise intervention', 'individually tailored (personalized) exercise program']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]",[],,0.110915,"RESULTS


Of 30 patients allocated to the exercise group","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ferguson', 'Affiliation': 'Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University, Newtownabby, United Kingdom.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Bradley', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University, Newtownabby, United Kingdom.'}]",Journal of intensive care medicine,['10.1177/0885066617724738']
1554,28871440,"Triheptanoin versus trioctanoin for long-chain fatty acid oxidation disorders: a double blinded, randomized controlled trial.","BACKGROUND


Observational reports suggest that supplementation that increases citric acid cycle intermediates via anaplerosis may have therapeutic advantages over traditional medium-chain triglyceride (MCT) treatment of long-chain fatty acid oxidation disorders (LC-FAODs) but controlled trials have not been reported. The goal of our study was to compare the effects of triheptanoin (C7), an anaplerotic seven-carbon fatty acid triglyceride, to trioctanoin (C8), an eight-carbon fatty acid triglyceride, in patients with LC-FAODs.
METHODS


A double blinded, randomized controlled trial of 32 subjects with LC-FAODs (carnitine palmitoyltransferase-2, very long-chain acylCoA dehydrogenase, trifunctional protein or long-chain 3-hydroxy acylCoA dehydrogenase deficiencies) who were randomly assigned a diet containing 20% of their total daily energy from either C7 or C8 for 4 months was conducted. Primary outcomes included changes in total energy expenditure (TEE), cardiac function by echocardiogram, exercise tolerance, and phosphocreatine recovery following acute exercise. Secondary outcomes included body composition, blood biomarkers, and adverse events, including incidence of rhabdomyolysis.
RESULTS


Patients in the C7 group increased left ventricular (LV) ejection fraction by 7.4% (p = 0.046) while experiencing a 20% (p = 0.041) decrease in LV wall mass on their resting echocardiogram. They also required a lower heart rate for the same amount of work during a moderate-intensity exercise stress test when compared to patients taking C8. There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups.
CONCLUSIONS


C7 improved LV ejection fraction and reduced LV mass at rest, as well as lowering heart rate during exercise among patients with LC-FAODs.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov NCT01379625.",2017,"There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups.
","['patients with LC-FAODs', '32 subjects with LC-FAODs (carnitine palmitoyltransferase-2, very long-chain acylCoA dehydrogenase, trifunctional protein or long-chain 3-hydroxy acylCoA dehydrogenase deficiencies']","['Triheptanoin versus trioctanoin', 'triheptanoin (C7), an anaplerotic seven-carbon fatty acid triglyceride, to trioctanoin (C8', 'diet containing 20% of their total daily energy from either C7 or C8']","['left ventricular (LV) ejection fraction', 'heart rate', 'lowering heart rate', 'TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis', 'LV ejection fraction and reduced LV mass', 'body composition, blood biomarkers, and adverse events, including incidence of rhabdomyolysis', 'LV wall mass on their resting echocardiogram', 'changes in total energy expenditure (TEE), cardiac function by echocardiogram, exercise tolerance, and phosphocreatine recovery following acute exercise']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007262', 'cui_str': 'Carnitine Acyltransferase I'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0077030', 'cui_str': 'glycerol tricaprylate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]",32.0,0.635348,"There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups.
","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA. gillingm@ohsu.edu.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': ""Neurogenetics and Metabolism, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.""}, {'ForeName': 'Areeg Hassan', 'Initials': 'AH', 'LastName': 'El-Gharbawy', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Deward', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Lasarev', 'Affiliation': 'Center for Research on Occupational and Environmental Toxicology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Pollaro', 'Affiliation': 'Advanced Imaging Research Center, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'DeLany', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Burchill', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Goodpaster', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shoemaker', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Saint Louis University, Saint Louis, MO, USA.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}]",Journal of inherited metabolic disease,['10.1007/s10545-017-0085-8']
1555,28810433,Ultra-brief non-expert-delivered defusion and acceptance exercises for food cravings: A partial replication study.,"Food cravings are a common barrier to losing weight. This article presents a randomised comparison of non-expert group-delivered ultra-brief  defusion  and  acceptance  interventions against a distraction control. A total of 63 participants were asked to carry a bag of chocolates for a week while trying to resist the temptation to eat them. A behavioural rebound measure was administered. Each intervention out-performed control in respect of consumption, but not cravings. These techniques may have a place in the clinical management of food cravings. We provide tentative evidence that the mechanism of action is through decreased reactivity to cravings, not through reduced frequency of cravings.",2019,"Each intervention out-performed control in respect of consumption, but not cravings.","['food cravings', '63 participants']","['non-expert group-delivered ultra-brief defusion and acceptance interventions against a distraction control', 'Ultra-brief non-expert-delivered defusion and acceptance exercises']",['Food cravings'],"[{'cui': 'C0872380', 'cui_str': 'Food craving'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}]",63.0,0.0336992,"Each intervention out-performed control in respect of consumption, but not cravings.","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hulbert-Williams', 'Affiliation': 'University of Chester, UK.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Hulbert-Williams', 'Affiliation': 'University of Chester, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Nicholls', 'Affiliation': 'University of Wolverhampton, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Williamson', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Jivone', 'Initials': 'J', 'LastName': 'Poonia', 'Affiliation': 'University of Wolverhampton, UK.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hochard', 'Affiliation': 'University of Chester, UK.'}]",Journal of health psychology,['10.1177/1359105317695424']
1556,28810464,The buddy system: A randomized controlled experiment of the benefits and costs of dieting in pairs.,"A total of 67 pairs of female roommates were randomized into a diet condition: (1) both ate normally; (2) one dieted, the other ate normally; and (3) both dieted. Adherence, weight loss, anxiety, depression, disordered eating symptoms, and stress were measured. Dieters lost more weight than non-dieters, but average loss was <1 pound. Pairs where both dieted reported higher anxiety, depression, and disordered eating than one-dieter pairs. Structural equation models revealed an interrelated network of stress, anxiety, depression, and disordered eating. This was weakest when one roommate dieted. The ""buddy system"" may not promote weight loss, but living with a non-dieting partner may buffer consequences.",2019,"Pairs where both dieted reported higher anxiety, depression, and disordered eating than one-dieter pairs.","['pairs', '67 pairs of female roommates']",['diet condition: (1) both ate normally'],"['Adherence, weight loss, anxiety, depression, disordered eating symptoms, and stress', 'anxiety, depression, and disordered eating', 'interrelated network of stress, anxiety, depression, and disordered eating']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0566568', 'cui_str': 'Eating normal (finding)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",67.0,0.0368891,"Pairs where both dieted reported higher anxiety, depression, and disordered eating than one-dieter pairs.","[{'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Incollingo Rodriguez', 'Affiliation': 'University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Callahan', 'Affiliation': 'University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Darby', 'Initials': 'D', 'LastName': 'Saxbe', 'Affiliation': 'University of Southern California (USC), USA.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'University of California, Los Angeles (UCLA), USA.'}]",Journal of health psychology,['10.1177/1359105317709514']
1557,28766404,Drug-Eluting Biopsy Needle as a Novel Strategy for Antimicrobial Prophylaxis in Transrectal Prostate Biopsy.,"OBJECTIVES


To preclinically evaluate drug-eluting biopsy needles (patent pending WO2016118026) as a new potential way of antimicrobial prophylaxis for transrectal prostate biopsy.
METHODS


Twenty steel biopsy needles have been coated with polyvinyl alcohol, ciprofloxacin, and amikacin. Modified biopsy needles have been randomly divided into 3 groups (1:2:1 ratio). Needles from group I were immersed for 30 minutes in dedicated test tubes containing saline. Needles from group II were immersed (one by one) for 5 seconds in a set of 12 test tubes containing saline. Then, each solution was analyzed using high-performance liquid chromatography. The results were compared with the susceptibility break points for  Escherichia coli . Group III was incubated with  E coli  strains on Mueller-Hinton plate and then the bacterial inhibition zones surrounding needles were measured.
RESULTS


The average concentration of antibiotics eluted from needles (group I) was 361.98 ± 15.36 µg/mL for amikacin and 63.87 ± 5.95 µg/mL for ciprofloxacin. The chromatographic analysis revealed the gradual release of both antibiotics from needles (group II). The concentration of amikacin released from needles exceeded the break-point value from first to ninth immersion. Ciprofloxacin concentration was higher than break-point value in all immersions. The average bacterial inhibition zone minor axis was 42 ± 5.7 mm (group III).
CONCLUSIONS


The use of drug-eluting biopsy needle could be a new potential way of antimicrobial prophylaxis for transrectal prostate biopsy. This study confirmed its biological activity as well as the gradual release of antibiotics from its surface. Confirmation of its preventive role, in terms of infectious complications after transrectal prostate biopsy, has to be evaluated in a clinical trial.",2017,Ciprofloxacin concentration was higher than break-point value in all immersions.,['Transrectal Prostate Biopsy'],"['amikacin', 'Drug-Eluting Biopsy Needle', 'Modified biopsy needles', 'ciprofloxacin', 'polyvinyl alcohol, ciprofloxacin, and amikacin']","['average concentration of antibiotics eluted', 'Ciprofloxacin concentration', 'concentration of amikacin']","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0181960', 'cui_str': 'Biopsy needle, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}]",,0.0189806,Ciprofloxacin concentration was higher than break-point value in all immersions.,"[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Sieczkowski', 'Affiliation': 'Department of Urology, Medical University of Gdańsk, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gibas', 'Affiliation': 'Department of Urology, Medical University of Gdańsk, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Wasik', 'Affiliation': 'Department of Analytical Chemistry, Gdańsk University of Technology, Gdańsk, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Kot-Wasik', 'Affiliation': 'Department of Analytical Chemistry, Gdańsk University of Technology, Gdańsk, Poland.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Piechowicz', 'Affiliation': 'Department of Microbiology, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Namieśnik', 'Affiliation': 'Department of Analytical Chemistry, Gdańsk University of Technology, Gdańsk, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Matuszewski', 'Affiliation': 'Department of Urology, Medical University of Gdańsk, Poland.'}]",Technology in cancer research & treatment,['10.1177/1533034617722080']
1558,28810385,Is a general or specific exercise recommendation more effective for promoting physical activity among postpartum mothers?,"This comparative effectiveness trial examined the effects of a behavior change intervention supplemented by a general or specific exercise recommendation on physical activity among postpartum mothers. Participants ( N = 49) attended three workshop sessions that provided the exercise recommendation and taught self-regulatory skills. Physical activity, self-efficacy, planning, and barriers were assessed at baseline, post-intervention, and 6-month follow-up. Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03). Both groups reported increased planning and decreased barriers. Postpartum mothers may benefit from interventions that teach strategies for overcoming barriers while allowing them to choose preferred activities.",2019,"Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03).","['Postpartum mothers', 'Participants ( N\u2009=\u200949) attended three', 'postpartum mothers']","['behavior change intervention supplemented by a general or specific exercise recommendation', 'workshop sessions that provided the exercise recommendation and taught self-regulatory skills']","['Self-reported physical activity', 'physical activity', 'Physical activity, self-efficacy, planning, and barriers']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0156241,"Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03).","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Kansas State University, USA.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Hsu', 'Affiliation': 'Kansas State University, USA.'}]",Journal of health psychology,['10.1177/1359105316687627']
1559,31368087,Impact of a Clinical Pharmacist Intervention on Medicine Costs in Patients with Chronic Obstructive Pulmonary Disease in India.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, especially in low- and middle-income countries (LMICs) such as India. Medicine costs are a key issue in LMICs, with typically high patient co-payments. In addition, pharmacists are underutilised in LMICs, including India. However, pharmacist-led educational interventions may improve the care of patients with COPD, as well as reduce medicine costs. Consequently, the objective of this study was to assess the effectiveness of a pharmacist-led intervention in reducing medicine costs.
METHODOLOGY


We assessed the impact of a pharmacist intervention on direct medicine costs in COPD patients (medicine costs and pharmacist time) in a randomised controlled study involving an intervention and control group, conducted at a tertiary care teaching hospital in India.
RESULTS


The 6-monthly cost of medicines at baseline increased with disease severity, from a maximum of US$29.46 for those with mild COPD to US$63.28 for those with very severe COPD. Substantial savings in medical costs were achieved with the pharmacist-led programme, to a maximum of US$20.49 over 6 months for very severe patients. This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
CONCLUSION


There could be a key role for pharmacists as educators for COPD patients in LMICs, to improve care and reduce costs, including patient co-payments.",2020,"This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
","['Chronic obstructive pulmonary disease (COPD', 'Patients with Chronic Obstructive Pulmonary Disease in India', 'tertiary care teaching hospital in India', 'COPD patients (medicine costs and pharmacist time']","['pharmacist intervention', 'Clinical Pharmacist Intervention', 'pharmacist-led intervention']","['Medicine Costs', 'direct medicine costs']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]",,0.0921208,"This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
","[{'ForeName': 'Suhaj', 'Initials': 'S', 'LastName': 'Abdulsalim', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Mazhuvancherry Kesavan', 'Initials': 'MK', 'LastName': 'Unnikrishnan', 'Affiliation': 'MCOPS, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Mohan K', 'Initials': 'MK', 'LastName': 'Manu', 'Affiliation': 'Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Alsahali', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Alian A', 'Initials': 'AA', 'LastName': 'Alrasheedy', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Antony P', 'Initials': 'AP', 'LastName': 'Martin', 'Affiliation': 'Health Economics Centre, University of Liverpool Management School, Liverpool, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Godman', 'Affiliation': 'Health Economics Centre, University of Liverpool Management School, Liverpool, UK. Brian.Godman@liverpool.ac.uk.'}, {'ForeName': 'Abubakr A', 'Initials': 'AA', 'LastName': 'Alfadl', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}]",PharmacoEconomics - open,['10.1007/s41669-019-0172-x']
1560,30417473,Effectiveness of a dissemination strategy on the uptake of an online menu planning program: A controlled trial.,"ISSUE ADDRESSED


Online systems offer opportunities to provide effective, ongoing support to childcare services to implement dietary guidelines. The study aimed to assess the effectiveness of a dissemination strategy on childcare service: (i) adoption; and (ii) use of an online menu planning program designed to increase compliance with dietary guidelines.
METHODS


A nonrandomised controlled trial was conducted with long day care services across Australia. All services received an email invitation to access an online evidence-based menu planning program. Services in the intervention also received training, telephone contact and provision of a portable computer tablet to encourage program adoption and use. Outcomes were assessed at the 6-month follow-up using analytics data recorded by the online program. Outcomes included the proportion of services having accessed the program (adoption) and the proportion of services with a current menu entered in the program (use as intended).
RESULTS


Twenty-seven interventions and 19 control services took part. At the 6-month follow-up, 100% vs 58% of services had adopted the online menu planning program (OR: 14.67, 95% CI: 2.43-infinity; P < 0.01) and 41% vs 5% of services had a current menu entered in the program (OR: 9.99, 95% CI: 1.01-534.57; P < 0.01) in the intervention and control arms respectively.
CONCLUSIONS


This study highlights the need for strategies to support adoption and use of an online menu planning program in childcare services if the potential benefits of such a program are to be achieved. Future research should explore the effectiveness of differing strategies to increase adoption and use of online programs at scale. SO WHAT?: Strategies to support childcare service uptake and use of online programs are required in order for the potential public health benefits of such technologies to be realised.",2019,"At the 6-month follow-up, 100% vs 58% of services had adopted the online menu planning program (OR: 14.67, 95% CI: 2.43-infinity; P < 0.01) and 41% vs 5% of services had a current menu entered in the program (OR: 9.99, 95% CI: 1.01-534.57; P < 0.01) in the intervention and control arms respectively.
",[],"['online menu planning program', 'email invitation to access an online evidence-based menu planning program']",['proportion of services having accessed the program (adoption) and the proportion of services with a current menu entered in the program (use as intended'],[],"[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0380726,"At the 6-month follow-up, 100% vs 58% of services had adopted the online menu planning program (OR: 14.67, 95% CI: 2.43-infinity; P < 0.01) and 41% vs 5% of services had a current menu entered in the program (OR: 9.99, 95% CI: 1.01-534.57; P < 0.01) in the intervention and control arms respectively.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'The University of Sydney, School of Public Health, Camperdown, NSW, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, NSW, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.220']
1561,30779529,Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.,"BACKGROUND


The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was unclear.
METHODS


In an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). The primary end points were overall survival and progression-free survival in the intention-to-treat population. The key secondary end point was the objective response rate. All reported results are from the protocol-specified first interim analysis.
RESULTS


After a median follow-up of 12.8 months, the estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab-axitinib group and 78.3% in the sunitinib group (hazard ratio for death, 0.53; 95% confidence interval [CI], 0.38 to 0.74; P<0.0001). Median progression-free survival was 15.1 months in the pembrolizumab-axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001). The objective response rate was 59.3% (95% CI, 54.5 to 63.9) in the pembrolizumab-axitinib group and 35.7% (95% CI, 31.1 to 40.4) in the sunitinib group (P<0.001). The benefit of pembrolizumab plus axitinib was observed across the International Metastatic Renal Cell Carcinoma Database Consortium risk groups (i.e., favorable, intermediate, and poor risk) and regardless of programmed death ligand 1 expression. Grade 3 or higher adverse events of any cause occurred in 75.8% of patients in the pembrolizumab-axitinib group and in 70.6% in the sunitinib group.
CONCLUSIONS


Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. (Funded by Merck Sharp & Dohme; KEYNOTE-426 ClinicalTrials.gov number, NCT02853331.).",2019,"Median progression-free survival was 15.1 months in the pembrolizumab-axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001).","['Advanced Renal-Cell Carcinoma', '861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive', 'patients with previously untreated advanced renal-cell carcinoma']","['Pembrolizumab plus Axitinib versus Sunitinib', 'pembrolizumab-axitinib', 'axitinib (5 mg) orally twice daily (432 patients) or sunitinib', 'pembrolizumab plus axitinib', 'pembrolizumab', 'pembrolizumab and axitinib']","['overall survival and progression-free survival', 'Grade 3 or higher adverse events', 'antitumor activity', 'objective response rate', 'Median progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",861.0,0.228568,"Median progression-free survival was 15.1 months in the pembrolizumab-axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001).","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Stus', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Rustem', 'Initials': 'R', 'LastName': 'Gafanov', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Nosov', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pouliot', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Soulières', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kryzhanivska', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Sergio J', 'Initials': 'SJ', 'LastName': 'Azevedo', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Borchiellini', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Szczylik', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Markus', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'McDermott', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Tartas', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Yen-Hwa', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tamada', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Shou', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Rodolfo F', 'Initials': 'RF', 'LastName': 'Perini', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""From the Cleveland Clinic Taussig Cancer Institute, Cleveland (B.I.R.); Fox Chase Cancer Center, Philadelphia (E.R.P.); Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine (V.S.) and Dnipropetrovsk Medical Academy (I.B.), Dnipro, Sumy State University, Sumy Regional Oncology Center, Sumy (I.V.), and Ivano-Frankivsk National Medical University, Ivano-Frankivsk (A.K.) - all in Ukraine; the Russian Scientific Center of Roentgen Radiology (R.G.), Central Clinical Hospital with Outpatient Clinic (D.N.), and Hertzen Moscow Cancer Research Institute (B.A.), Moscow; the Christie NHS Foundation Trust, Manchester (R.H.), and Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London (T.P.) - all in the United Kingdom; Centre Hospitalier Universitaire (CHU) de Québec and Université Laval, Quebec, QC (F.P.), and CHU de Montréal, Montreal (D.S.) - both in Canada; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (S.J.A.); Centre Antoine Lacassagne, Université Côte d'Azur, Nice (D.B.), and Hôpitaux Universitaires de Lyon, Lyon (S. Tartas) - both in France; Military Institute of Medicine, Warsaw, Poland (C.S.); Rocky Mountain Cancer Center, Colorado Springs, CO (M.M.); Adelaide and Meath Hospital and University College Dublin, Dublin (R.S.M.); the Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany (J.B.); Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Osaka City University Hospital, Osaka, Japan (S. Tamada); MSD China, Beijing (Q.S.); Merck, Kenilworth, NJ (R.F.P., M.C.); and Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1816714']
1562,28664173,Dietary amino acid intakes associated with a low-phenylalanine diet combined with amino acid medical foods and glycomacropeptide medical foods and neuropsychological outcomes in subjects with phenylketonuria.,"This article provides original data on median dietary intake of 18 amino acids from amino acid medical foods, glycomacropeptide medical foods, and natural foods based on 3-day food records obtained from subjects with phenylketonuria who consumed low-phenylalanine diets in combination with amino acid medical foods and glycomacropeptide medical foods for 3 weeks each in a crossover design. The sample size of 30 subjects included 20 subjects with classical phenylketonuria and 10 with a milder or variant form of phenylketonuria. Results are presented for the Delis-Kaplan Executive Function System and the Cambridge Neuropsychological Test Automated Battery; the tests were administered at the end of each 3-week dietary treatment with amino acid medical foods and glycomacropeptide medical foods. The data are supplemental to our clinical trial, entitled ""Glycomacropetide for nutritional management of phenylketonuria: a randomized, controlled, crossover trial, 2016 (1) and ""Metabolomic changes demonstrate reduced bioavailability of tyrosine and altered metabolism of tryptophan via the kynurenine pathway with ingestion of medical foods in phenylketonuria, 2017 (2). This data has been made public and has utility to clinicians and researchers due to the following: 1) This provides the first comprehensive report of typical intakes of 18 amino acids from natural foods, as well as amino acid and glycomacropeptide medical foods in adolescents and adults with phenylketonuria; and 2) This is the first evidence of similar standardized neuropsychological testing data in adolescents and adults with early-treated phenylketonuria who consumed amino acid and glycomacropeptide medical foods.",2017,Results are presented for the Delis-Kaplan Executive Function System and the Cambridge Neuropsychological Test Automated Battery; the tests were administered at the end of each 3-week dietary treatment with amino acid medical foods and glycomacropeptide medical foods.,"['subjects with phenylketonuria', '18 amino acids from amino acid medical foods, glycomacropeptide medical foods, and natural foods based on 3-day food records obtained from subjects with phenylketonuria who consumed low-phenylalanine diets in combination with amino acid medical foods and glycomacropeptide medical foods for 3 weeks each in a crossover design', '30 subjects included 20 subjects with classical phenylketonuria and 10 with a milder or variant form of phenylketonuria', 'adolescents and adults with early-treated phenylketonuria who consumed amino acid and glycomacropeptide medical foods']",[],[],"[{'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C2927194', 'cui_str': 'Medical food (substance)'}, {'cui': 'C0286762', 'cui_str': 'glycomacropeptide'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0457976', 'cui_str': 'Phenylalanine-free diet'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",[],[],20.0,0.0381254,Results are presented for the Delis-Kaplan Executive Function System and the Cambridge Neuropsychological Test Automated Battery; the tests were administered at the end of each 3-week dietary treatment with amino acid medical foods and glycomacropeptide medical foods.,"[{'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Stroup', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, WI, United States.'}, {'ForeName': 'Sangita G', 'Initials': 'SG', 'LastName': 'Murali', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, WI, United States.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, WI, United States.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Sawin', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, WI, United States.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Rohr', 'Affiliation': 'Division of Genetics and Genomics, Boston Children׳s Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Harvey L', 'Initials': 'HL', 'LastName': 'Levy', 'Affiliation': 'Division of Genetics and Genomics, Boston Children׳s Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Ney', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, WI, United States.'}]",Data in brief,['10.1016/j.dib.2017.06.004']
1563,31505986,Adaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter.,"A clinical endpoint bioequivalence (BE) study is often used to establish bioequivalence (BE) between a locally acting generic drug (T) and an innovator drug (R), which is a double-blind, randomized three-arm (T, R and placebo: P) parallel clinical trial. BE is established if two superiority tests (T vs. P, R vs. P) and one equivalence test (T vs. R) all pass. An accurate estimate of the nuisance parameter (e.g. variance) is vital in determining an accurate sample size to attain sufficient power. However, due to potential study design variations between NDA and Abbreviated NDA (ANDA) studies and high variability of clinical endpoints, variance may be over- or under-estimated, resulting in unnecessary extra costs or underpowered studies. Traditionally, clinical endpoint BE studies use a fixed study design. In this work, we propose four sample size re-estimation approaches based on a nuisance parameter and recommend one approach after comparing various operating characteristics by simulation. The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.",2019,"The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.232121,"The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Louisiana State University Health Sciences Center , New Orleans , LA , USA.'}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'OB/DBVIII, FDA/CDER , Silver Spring , MD , USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1657143']
1564,27646850,Effect of Fibrin Glue on the Incidence of Surgical Complications After Living-Related-Donor Kidney Transplantation: Results of a Randomized Clinical Trial.,"BACKGROUND The incidence of surgical complications after kidney transplantation ranges from 10-25%. The purpose of this study was to evaluate if the application of fibrin glue as a preventive agent reduces surgical morbidity after a living-related-donor kidney transplantation. MATERIAL AND METHODS A controlled clinical trial involving 78 recipients randomly assigned to receive fibrin glue and 79 in the control group without the application of fibrin glue. Patients were followed for six months after surgery. RESULTS The average ages were 24.8±9.4 and 27.4±11.3 years in the control and study groups, respectively (p=0.11). Individual morbidities, such as urologic, lymphatic, vascular, and wound complications, were not statistically different between groups; however, the total number of surgical complications observed were in five patients in the study group and 16 patients in the control group. This difference was statistically significant (p<0.01, relative risk 0.44, 95% CI 0.20-0.97). There was no mortality or adverse reaction to fibrin glue. One kidney graft was lost because of uncontrollable bleeding secondary to tearing of the renal capsule. The incidence of early medical complications was similar between groups. CONCLUSIONS Applications of the biological adhesive reduced the incidence of surgical complications.",2016,There was no mortality or adverse reaction to fibrin glue.,"['after a living-related-donor kidney transplantation', '78 recipients randomly assigned to receive', 'After Living-Related-Donor Kidney Transplantation']","['Fibrin Glue', 'fibrin glue']","['surgical morbidity', 'Incidence of Surgical Complications', 'incidence of surgical complications', 'total number of surgical complications', 'incidence of early medical complications', 'surgical complications', 'Individual morbidities, such as urologic, lymphatic, vascular, and wound complications', 'mortality or adverse reaction']","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C1096106'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",78.0,0.10869,There was no mortality or adverse reaction to fibrin glue.,"[{'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Fuentes-Orozco', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'González-Mercado', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Joel Mario', 'Initials': 'JM', 'LastName': 'Sandoval-Sandoval', 'Affiliation': 'Department of Urology and Transplant, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Valdespino-Mejía', 'Affiliation': 'Department of Vascular and Solid Organ Transplant, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'González-González', 'Affiliation': 'Department of Urology and Transplant, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Juan Narciso', 'Initials': 'JN', 'LastName': 'Ramírez-Robles', 'Affiliation': 'Department of Vascular and Solid Organ Transplant, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Gómez-Navarro', 'Affiliation': 'Department of Nephrology, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Blanca Estela', 'Initials': 'BE', 'LastName': 'Dávalos-Delgadillo', 'Affiliation': 'Department of Anesthesiology, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Marquez-Leaño', 'Affiliation': 'Department of Anesthesiology, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Chávez-Tostado', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Ramírez-Arce', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Andalón-Dueñas', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Espinosa-Partida', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Michel Dassaejv', 'Initials': 'MD', 'LastName': 'Macías-Amezcua', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Ojeda', 'Affiliation': 'Biomedical Research Unit 02, Specialties Hospital, Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico.'}]",Annals of transplantation,[]
1565,31592915,Combination Therapy of Microneedle Fractional Radiofrequency and Topical Poly-Lactic Acid for Acne Scars: A Randomized Controlled Split-Face Study.,"BACKGROUND


Acne scarring occurs at a young age and causes distress for many patients. Various treatment modalities have been tried.
OBJECTIVE


This study investigated the efficacy of combination therapy with topical poly-lactic acid and microneedle fractional radiofrequency (MFRF) for acne scars.
MATERIALS AND METHODS


Patients with acne scars on both the cheeks were included. Poly-lactic acid was applied to the acne scars on one side of the face before MFRF treatment. The other side of the face was treated with MFRF and normal saline. Patients received 3 treatment sessions and were evaluated based on visual assessment and patient satisfaction. After the last treatment, objective scar assessment of scar smoothness, size, brightness, and overall improvement was performed.
RESULTS


Both acne scar assessment scores and patient satisfaction were better with combination therapy (p = .036 and p = .009, respectively) than with monotherapy. Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
CONCLUSION


Combination therapy resulted in significantly better clinical outcomes, including better scar smoothness and smaller scar size. Therefore, we believe this combination therapy is a safe and effective treatment for acne scars.",2020,"Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
","['Acne Scars', 'Patients with acne scars on both the cheeks were included']","['Microneedle Fractional Radiofrequency and Topical Poly-Lactic Acid', 'topical poly-lactic acid and microneedle fractional radiofrequency (MFRF', 'Poly-lactic acid', 'MFRF and normal saline']","['efficacy for scar smoothness', 'scar smoothness and smaller scar size', 'scar size', 'acne scar assessment scores and patient satisfaction', 'objective scar assessment of scar smoothness, size, brightness, and overall improvement']","[{'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007966', 'cui_str': 'Bucca'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0325954,"Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
","[{'ForeName': 'Min K', 'Initials': 'MK', 'LastName': 'An', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Eun H', 'Initials': 'EH', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Suk B', 'Initials': 'SB', 'LastName': 'Suh', 'Affiliation': 'SeoASong Dermatologic Clinic, Seoul, Korea.'}, {'ForeName': 'Eun J', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Kwang H', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002175']
1566,28569990,"Prospective, Randomized, Multicenter, Controlled Trial (TRIATHRON 1) on a New Antithrombogenic Hydrophilic Dialysis Membrane.","INTRODUCTION


Hemodialysis treatment requires anticoagulation to prevent thrombosis of the dialyzer. The Hydrolink ®  (NV series; Toray) has been designed to reduce thrombotic complications by increasing membrane hydrophilic properties. Previous studies have confirmed reduced platelet activation, improved removal of β2-microglobulin and excellent small-solute removal.
METHODS


We designed a prospective, multi-centered, randomized clinical study to compare the antithrombogenic effects (platelet count) of NV dialyzers versus conventional treatment. To compare the possibility of performing heparin-free dialysis, we carried out progressive heparin reduction tests. Patients with an average platelet count lower than 170,000 cells/mm 3  using standard high flux membranes in the 6 months prior to the study were enrolled and randomized. Patients were either dialyzed for 6 months without changing the previous membrane (control group) or treated with the Hydrolink ®  membrane (NV group). After the third week, the heparin reduction test was conducted for 5 weeks in order to assess the minimum amount of anticoagulant needed to safely perform a 4-hour dialysis treatment. Performance and safety were evaluated measuring platelet count and activation, middle-molecule removal rate and nutritional status.
RESULTS


We found no significant difference in platelet count, platelet activation factors β-thromboglobulin and platelet factor 4 (PF-4), between the groups. More patients in the study group reached heparin-free dialysis without clotting events during the heparin reduction test. The NV dialyzers displayed anti-thrombogenic effects as compared to conventional dialyzers.
CONCLUSIONS


The NV dialyzer series is safe with no adverse events reported. Further studies are required to understand the mechanisms of anti-thrombogenic effects.",2017,"We found no significant difference in platelet count, platelet activation factors β-thromboglobulin and platelet factor 4 (PF-4), between the groups.",[],"['heparin-free dialysis', 'dialyzed for 6 months without changing the previous membrane (control group) or treated with the Hydrolink® membrane (NV group', 'heparin', 'NV dialyzers versus conventional treatment']","['heparin-free dialysis without clotting events', 'platelet count and activation, middle-molecule removal rate and nutritional status', 'Performance and safety', 'platelet count, platelet activation factors β-thromboglobulin and platelet factor 4 (PF-4']",[],"[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0063092', 'cui_str': 'HydroLink'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0522872', 'cui_str': 'Platelet factor 4 assay (procedure)'}]",,0.0192293,"We found no significant difference in platelet count, platelet activation factors β-thromboglobulin and platelet factor 4 (PF-4), between the groups.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Ronco', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Brendolan', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Nalesso', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Zanella', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Cal', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Corradi', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Grazia M', 'Initials': 'GM', 'LastName': 'Virzì', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Fiorenza', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Garzotto', 'Affiliation': 'Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza - Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lorenzin', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Aakash N', 'Initials': 'AN', 'LastName': 'Karopadi', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sartori', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Rosa', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Samoni', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Faeq', 'Initials': 'F', 'LastName': 'Husain-Syed', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spinelli', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Neri', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Villa', 'Affiliation': 'International Renal Research Institute of Vicenza (IRRIV), Vicenza - Italy.'}, {'ForeName': 'Alberta', 'Initials': 'A', 'LastName': 'Alghisi', 'Affiliation': 'Department of Immunology and Blood Transfusion, San Bortolo Hospital, Vicenza - Italy.'}]",The International journal of artificial organs,['10.5301/ijao.5000608']
1567,31581929,Remote ischemic conditioning for acute moderate ischemic stroke (RICAMIS): Rationale and design.,"RATIONALE


A large number of basic and clinical studies have proved that remote ischemic conditioning has neuroprotective effect. For example, remote ischemic conditioning showed a neuroprotective role in cerebral ischemia-reperfusion injury model. Recent clinical studies suggested that remote ischemic conditioning may improve neurological function and reduce the risk of recurrence in ischemic stroke patients. However, there is a lack of convincing evidence for the neuroprotective effect of remote ischemic conditioning on ischemic stroke, which deserves further study.
AIM


To explore the efficacy and safety of remote ischemic conditioning for acute moderate ischemic stroke.
SAMPLE SIZE ESTIMATES


A maximum of 1800 subjects are required to test the superiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by gender, age, time from onset to treatment, National Institutes of Health Stroke Scale (6-10 vs. 11-16), degree of responsible vessel stenosis, location of stenosis, and stroke etiology.
METHODS AND DESIGN


Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke is a prospective, random, open label, blinded endpoint and multi-center study. The subjects are divided into experimental group and control group randomly. The experimental group was treated with remote ischemic conditioning twice daily with 200 mmHg pressure for 10-14 days besides guideline-based therapy. The control group was treated according to the guidelines.
STUDY OUTCOME


The primary efficacy endpoint is favorable functional outcome, defined as modified Rankin Scale 0-1 at 90 days post-randomization.",2020,"The primary efficacy endpoint is favorable functional outcome, defined as modified Rankin Scale 0-1 at 90 days post-randomization.","['ischemic stroke patients', 'acute moderate ischemic stroke (RICAMIS', '1800 subjects are required to test the superiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by gender, age, time from onset to treatment, National Institutes of Health Stroke Scale (6-10 vs. 11-16), degree of responsible vessel stenosis, location of stenosis, and stroke etiology']","['Remote ischemic conditioning', 'remote ischemic conditioning twice daily with 200\u2009mmHg pressure for 10-14 days besides guideline-based therapy', 'remote ischemic conditioning']","['efficacy and safety', 'neurological function', 'favorable functional outcome, defined as modified Rankin Scale 0-1 at 90 days post-randomization']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4517400', 'cui_str': 'Zero point zero two five'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",1800.0,0.0192561,"The primary efficacy endpoint is favorable functional outcome, defined as modified Rankin Scale 0-1 at 90 days post-randomization.","[{'ForeName': 'Xiao-Qiu', 'Initials': 'XQ', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}, {'ForeName': 'Zhong-He', 'Initials': 'ZH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}, {'ForeName': 'Hui-Sheng', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, P.R. China.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019879651']
1568,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087']
1569,30304527,Education Differentially Buffers Cognitive Performance in Black and White Older Adults.,"OBJECTIVES


Given that black American older adults are more likely to have lower educational attainment and perform worse on cognitive tests than white Americans, we examined whether increased education would confer greater cognitive advantage to black Americans on measures of global and specific domains of cognitive function.
METHODS


The sample included 522 community-dwelling older adults from a larger study. An analysis of covariance was conducted with race and education as between-participant factors and global cognition as the dependent variable. A multivariate analysis of covariance was conducted with five cognitive domains (immediate memory, visuospatial/constructional ability, language, attention, and delayed memory) as the dependent variables.
RESULTS


Significant main effects indicated that black Americans, F(1,516) = 29.18, p < .001, and individuals with less education, F(1,516) = 44.93, p < .001, evidenced lower cognitive functioning, controlling for age and overall health status, and the interaction term reached statistical significance, F(1,516) = 7.95, p = .005. The impact of education on global cognitive function for black participants was more than twice as large (Cohen's d = 1.30) than for white participants (Cohen's d = .52). There was a significant race × education interaction for the cognitive domain of attention (p < .001) and a composite measure of non-memory domains (i.e., language, visuospatial/constructional, and attention; p < .001).
DISCUSSION


Our findings suggest that educational attainment is particularly important for black Americans with respect to global cognitive function, attention, and non-memory domains.",2019,"There was a significant race × education interaction for the cognitive domain of attention (p < .001) and a composite measure of non-memory domains (i.e., language, visuospatial/constructional, and attention; p < .001).
","['522 community-dwelling older adults from a larger study', 'Education Differentially Buffers Cognitive Performance in Black and White Older Adults', 'black Americans', 'black participants', 'black American older adults']",[],"['five cognitive domains (immediate memory, visuospatial/constructional ability, language, attention, and delayed memory', 'global cognitive function', 'lower cognitive functioning, controlling for age and overall health status']","[{'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",522.0,0.0460595,"There was a significant race × education interaction for the cognitive domain of attention (p < .001) and a composite measure of non-memory domains (i.e., language, visuospatial/constructional, and attention; p < .001).
","[{'ForeName': 'Kharine R', 'Initials': 'KR', 'LastName': 'Jean', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}, {'ForeName': 'Cutter A', 'Initials': 'CA', 'LastName': 'Lindbergh', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Mewborn', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}, {'ForeName': 'Talia L', 'Initials': 'TL', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Gogniat', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}, {'ForeName': 'L Stephen', 'Initials': 'LS', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, Franklin College of Arts and Sciences, University of Georgia, Athens.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby116']
1570,26994063,Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.,"Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls.",2016,"This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls.",[],[],[],[],[],[],,0.111497,"This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls.","[{'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robins', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwv254']
1571,31587091,"Intra-articular injection of culture-expanded mesenchymal stem cells with or without addition of platelet-rich plasma is effective in decreasing pain and symptoms in knee osteoarthritis: a controlled, double-blind clinical trial.","PURPOSE


To compare the clinical and laboratory outcomes of intra-articular injections of culture-expanded bone-derived mesenchymal stem cells (MSCs) with or without platelet-rich plasma (PRP) to intra-articular corticosteroid injections for the treatment of knee osteoarthritis (OA).
METHODS


Forty-seven patients with radiographic and symptomatic knee OA were randomized into three groups for intra-articular injections: autologous bone marrow-derived culture-expanded MSCs (n = 16); autologous bone marrow-derived culture-expanded MSCs + PRP (n = 14); and corticosteroid (n = 17). The outcomes were assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and range of motion (ROM) at baseline, 1, 2, 3, 6, 9 and 12 months and intra-articular cytokines analysis at baseline, 6 and 12 months postoperatively.
RESULTS


The three groups showed significant improvement in most KOOS domains and global score at 1st month and all domains and global score at 12-month follow-up (p < 0.05). At the 1st month, only the MSCs group showed significant differences in KOOS symptoms domain (p = 0.003). The MSCs and MSCs + PRP groups showed the highest percentage of improvement in most KOOS domains and global score compared to the corticosteroid group. All three groups showed a significant reduction in intra-articular levels of human interleukin-10 cytokine, from baseline to 12 months (p < 0.05).
CONCLUSION


An intra-articular injection of bone marrow-derived culture-expanded MSCs with or without the addiction of PRP is effective in improving the function and decreasing symptoms caused by knee OA at 12-month follow-up.
LEVEL OF EVIDENCE


II.",2020,"All three groups showed a significant reduction in intra-articular levels of human interleukin-10 cytokine, from baseline to 12 months (p < 0.05).
","['knee osteoarthritis', 'Forty-seven patients with radiographic and symptomatic knee OA', 'knee osteoarthritis (OA']","['intra-articular injections: autologous bone marrow-derived culture-expanded MSCs (n\u2009=\u200916); autologous bone marrow-derived culture-expanded MSCs\u2009+\u2009PRP', 'corticosteroid', 'Intra-articular injection of culture-expanded mesenchymal stem cells with or without addition of platelet-rich plasma', 'bone marrow-derived culture-expanded MSCs', 'intra-articular injections of culture-expanded bone-derived mesenchymal stem cells (MSCs) with or without platelet-rich plasma (PRP) to intra-articular corticosteroid injections']","['intra-articular levels of human interleukin-10 cytokine', 'pain and symptoms', 'global score', 'Knee Injury and Osteoarthritis Outcome Score (KOOS) and range of motion (ROM) at baseline, 1, 2, 3, 6, 9 and 12\xa0months and intra-articular cytokines analysis', 'most KOOS domains and global score', 'KOOS symptoms domain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",47.0,0.0514602,"All three groups showed a significant reduction in intra-articular levels of human interleukin-10 cytokine, from baseline to 12 months (p < 0.05).
","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Bastos', 'Affiliation': 'Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence, Porto, Portugal.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Mathias', 'Affiliation': 'Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Andrade', 'Affiliation': 'Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence, Porto, Portugal.'}, {'ForeName': 'Ronaldo J F C', 'Initials': 'RJFC', 'LastName': 'Amaral', 'Affiliation': 'Kearney Lab, Department of Anatomy, Royal College of Surgeons in Ireland (RCSI), Dublin 2, Ireland.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Schott', 'Affiliation': 'Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Balduino', 'Affiliation': 'Excellion, Nireói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bastos', 'Affiliation': 'Hospital Lusíadas, Porto, Portugal.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Miguel Oliveira', 'Affiliation': ""3B's Research Group-Biomaterials, Biodegradables and Biomimetics, Headquarters of the European Institute of Excellence on Tissue Engineering and Regenerative Medicine, University of Minho, AvePark, Parque de Ciência e Tecnologia, Zona Industrial da Gandra, Barco, 4805-017, Guimarães, Portugal.""}, {'ForeName': 'Rui L', 'Initials': 'RL', 'LastName': 'Reis', 'Affiliation': ""3B's Research Group-Biomaterials, Biodegradables and Biomimetics, Headquarters of the European Institute of Excellence on Tissue Engineering and Regenerative Medicine, University of Minho, AvePark, Parque de Ciência e Tecnologia, Zona Industrial da Gandra, Barco, 4805-017, Guimarães, Portugal.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rodeo', 'Affiliation': 'Sports Medicine and Shoulder Surgery, Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Espregueira-Mendes', 'Affiliation': 'Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence, Porto, Portugal. espregueira@dhresearchcentre.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05732-8']
1572,31084264,Together to end violence against women in Tanzania: Results of a pilot cluster randomized controlled trial to evaluate preliminary effectiveness of interpersonal and community level interventions to address intimate partner violence.,"In Tanzania, women suffer high rates of intimate partner violence (IPV). We conducted a pilot cluster randomised controlled trial to test the feasibility, acceptability and preliminary effectiveness of IPV prevention interventions targeting men and communities in nine villages randomly assigned to one of three study arms ( n  = 450 couples). In the Control Group, women participated in savings groups while male partners received no intervention. In Intervention Group 1, women participated in savings groups and men participated in peer-groups addressing gender relations and IPV prevention. In Intervention Group 2, women participated in savings groups, men participated in peer-groups, and community leaders facilitated dialogues on similar topics. Recruitment was completed within one month with 95% retained in the intervention and 81% retained in the endline survey. Acceptability was high, with men participating in 82% of peer-group session hours. More men in Interventions 1 (24%) and 2 (19%) disagreed with wife-beating compared to men in the Control (13%); and more men reported non-perpetration of IPV in Interventions 1 (16%) and 2 (14%) compared to the Control (-2%). Findings suggest a fully powered RCT may detect significant reductions in men's justification and use of IPV, paving the way for evidence-based violence prevention programming.  Trial registration:  This study is registered with ClinicalTrials.gov. Identifier: NCT02434796.",2019,More men in Interventions 1 (24%) and 2 (19%) disagreed with wife-beating compared to men in the Control (13%); and more men reported non-perpetration of IPV in Interventions 1 (16%) and 2 (14%) compared to the Control (-2%).,"['men and communities in nine villages randomly assigned to one of three study arms (n = 450 couples', 'address intimate partner violence', 'violence against women in Tanzania']","['IPV prevention interventions', 'interpersonal and community level interventions']",['Acceptability'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",450.0,0.115114,More men in Interventions 1 (24%) and 2 (19%) disagreed with wife-beating compared to men in the Control (13%); and more men reported non-perpetration of IPV in Interventions 1 (16%) and 2 (14%) compared to the Control (-2%).,"[{'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Steven Mzilangwe', 'Affiliation': 'Muhimbili University of Health and Allied Sciences , Dar es Salaam , Tanzania.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Reich', 'Affiliation': 'World Education Inc./Bantwana (WEI/Bantwana) , Boston , MA , USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Badi', 'Affiliation': 'World Education Inc./Bantwana (WEI/Bantwana) , Arusha , Tanzania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simmons', 'Affiliation': 'Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Servidone', 'Affiliation': 'Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Bingham Holmes', 'Affiliation': 'Boston University School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Philbert', 'Initials': 'P', 'LastName': 'Kawemama', 'Affiliation': ""Prime Minister's Office , Dar es Salaam , Tanzania.""}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Boston University School of Public Health , Boston , MA , USA.'}]",Global public health,['10.1080/17441692.2019.1609062']
1573,31518207,The effect of palliative care intervention program on the quality of life among Jordanian caregivers of cancer patients.,"The purpose of this study was to evaluate the effect of palliative care intervention on the quality of life among Jordanian caregivers of cancer patients. Repeated measures design was used in this study. Data were collected from 137 Jordanian caregivers of cancer patients utilizing a self-administered questionnaire. An intervention program called SHARE was implemented to the experimental groups and its effectiveness in improving the overall quality of life for caregivers of cancer patients was evaluated using repeated measure ANOVA test. The results showed a statistically significant effect on the quality of life domains. For workshop experimental group (F = 26.822, p < .001) and for home visit experimental group (F = 10.236, p = .003).",2019,"For workshop experimental group (F = 26.822, p < .001) and for home visit experimental group (F = 10.236, p = .003).","['Jordanian caregivers of cancer patients', '137 Jordanian caregivers of cancer patients utilizing a self-administered questionnaire']","['palliative care intervention program', 'palliative care intervention']","['quality of life domains', 'overall quality of life', 'quality of life']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0195906,"For workshop experimental group (F = 26.822, p < .001) and for home visit experimental group (F = 10.236, p = .003).","[{'ForeName': 'Mohammad K', 'Initials': 'MK', 'LastName': 'Bani Younis', 'Affiliation': 'Princess Aisha Bint Al-Hussein College of Nursing & Health Sciences, Al-Hussein Bin Talal University , Maan , Jordan.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Rawashdeh', 'Affiliation': 'Princess Aisha Bint Al-Hussein College of Nursing & Health Sciences, Al-Hussein Bin Talal University , Maan , Jordan.'}, {'ForeName': 'Rafi M', 'Initials': 'RM', 'LastName': 'Alnjadat', 'Affiliation': 'Medical College, University of Sharjah , Sharjah , UAE.'}]",Home health care services quarterly,['10.1080/01621424.2019.1661325']
1574,32413673,The effects of testosterone on the physiological response to social and somatic stressors.,"Higher testosterone levels in males have previously been linked to decreased stress reactivity, but in other cases, testosterone has been reported to increase the stress response. We addressed these inconsistencies in a placebo-controlled single-dose testosterone administration study, in which 120 male participants were randomly assigned to undergo a cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition). Throughout the experiment, blood pressure and interbeat intervals were measured continuously, and saliva samples for hormonal analyses were taken repeatedly at predefined time points. When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies. However, testosterone administration altered this pattern. Compared to placebo, testosterone increased systolic blood pressure during the CPT, whereas the opposite effect was found during the SECPT. Cortisol reactivity was not affected by testosterone administration. The CAG repeat polymorphism of the androgen receptor gene was unrelated to the effects of testosterone on the stress response, but it was correlated with blood pressure across the whole sample. Our findings demonstrate that testosterone's effects on the stress response are dependent on the social context. Testosterone's ability to flexibly influence the response to stressors may be an important mechanism through which the hormone promotes adaptive behavior. Our results are also in line with research showing that testosterone decreases social anxiety and suggest it may help to modulate the effects of stress in socially challenging situations.",2020,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.",['120 male participants'],"['SECPT', 'placebo, testosterone', 'testosterone', 'placebo-controlled single-dose testosterone', 'Testosterone', 'cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition', 'placebo']","['blood pressure', 'blood pressure and interbeat intervals', 'systolic blood pressure', 'social anxiety', 'Cortisol reactivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.036,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Jaroslava Babková', 'Initials': 'JB', 'LastName': 'Durdiaková', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, Sasinkova 2, 813 72 Bratislava, Slovakia. Electronic address: durdiakova.jaroslava@fmed.uniba.sk.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Institute of Biomedical Science, FH Joanneum University of Applied Sciences, Eggenberger Allee 13, 8020 Graz, Austria. Electronic address: bernhard.wagner@fh-joanneum.at.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Vlček', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Dúbravská cesta 9, 845 05 Bratislava, Slovakia. Electronic address: miroslav.vlcek@savba.sk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Riečanský', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: igor.riecansky@savba.sk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104693']
1575,31586420,"Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5.","OBJECTIVE


To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study.
METHODS


Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random slope) at weeks 24 and 52, and observed data at week 52. Assessments at week 52 included additional efficacy endpoints (non-responders imputation and mixed-effects models for repeated measures) and safety.
RESULTS


The majority (86.6%) of patients completed 52 weeks of treatment. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ⩽0.5) was 91.8, 85.2 and 87.2% in 300, 150 and 150 mg no load groups, respectively, at week 52. The change in vdH-mTSS from baseline to week 52 using random slope [mean change (s.e.)] was -0.18 (0.17), 0.11 (0.18) and -0.20 (0.18) in 300, 150 and 150 mg no load groups, respectively; the corresponding observed data [mean change (s.d.)] was -0.09 (1.02), 0.13 (1.39) and 0.21 (1.15). Clinical efficacy endpoints were sustained, and no new or unexpected safety signals were reported through 52 weeks.
CONCLUSION


Secukinumab 300 and 150 mg with or without s.c. loading regimen provided sustained low rates of radiographic progression through 52 weeks of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT02404350.",2020,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"['Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response', 'psoriatic arthritis', 'patients with PsA from the FUTURE 5 study']","['placebo', 'Secukinumab', 'secukinumab 300 mg load', 'secukinumab']","['radiographic progression', 'safety', 'Radiographic progression', 'change in vdH-mTSS', 'proportion of patients with no radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0869609,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Department of Rheumatology, University of Amsterdam and Atrium Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Faculty of Medicine, Memorial University, St Johns, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Rheumatology, Whipps Cross Hospital, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Southwest Rheumatology, Dallas, TX, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Boettcher', 'Affiliation': 'Rheumazentrum Favoriten, Vienna, Austria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Navarra', 'Affiliation': ""St Luke's Medical Center, University of Santo Tomas Hospital, Manila, Philippines.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ligozio', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Readie', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez420']
1576,30526230,"Riluzole for treatment of men with methamphetamine dependence: A randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions.
AIMS


We assessed riluzole for treatment of methamphetamine dependence.
METHODS


In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18-65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole.
RESULTS


Concerning primary outcomes, the cumulative mean number of attended weekly visits was higher in the riluzole arm compared with the placebo arm approaching a statistically significant difference (riluzole, median (range)=13.00 (2.00-13.00); placebo=4.00 (2.00-13.00); Mann-Whitney U=505.00, p-value=0.073), and the weekly measured rate of positive methamphetamine urine test results was significantly lower in the riluzole arm by the end of the study (riluzole=1 (5.00%), placebo=9 (45.00%), p-value=0.004). Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint. No significant difference was detected between the two arms in terms of incidence of adverse events.
CONCLUSION


Future randomized clinical trials are needed to investigate proper dosing strategy in a more inclusive sample.",2019,"Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint.","['Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole', 'men with methamphetamine dependence', 'male outpatients with methamphetamine dependence who were 18-65 years old received either']","['50 mg riluzole', 'placebo', 'Riluzole', 'riluzole']","['rate of positive methamphetamine urine test results', 'incidence of adverse events', 'craving, withdrawal, and depression measures', 'cumulative mean number of attended weekly visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3540005', 'cui_str': 'URINE TESTS'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C3540005', 'cui_str': 'URINE TESTS'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]",,0.575116,"Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint.","[{'ForeName': 'Mohammad-Hadi', 'Initials': 'MH', 'LastName': 'Farahzadi', 'Affiliation': '1 Department of Neuroscience and Addiction Studies, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Moazen-Zadeh', 'Affiliation': '2 Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Emran', 'Initials': 'E', 'LastName': 'Razaghi', 'Affiliation': '3 Department of Psychiatry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Zarrindast', 'Affiliation': '1 Department of Neuroscience and Addiction Studies, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bidaki', 'Affiliation': '4 Research Center of Addiction and Behavioral Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': '2 Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118817166']
1577,28332858,Modified Cognitive Behavioral Therapy for Insomnia in Depressed Adolescents: A Pilot Study.,"Objective/Background:  The purpose of the study was to pilot a five-week insomnia treatment in adolescents with major depressive disorder (MDD) and insomnia. This was an open-label trial of a modified-group cognitive behavioral therapy for insomnia (CBTI).  Participants:  Adolescents with MDD ( n  = 16; mean age = 17.3 +/- 1.7), characterized by the Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score of ≥ 7 participated.  Methods:  Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI) were completed.  Results:  Paired  t -tests comparing pre- and posttreatment revealed a decrease in sleep onset latency from 41 min +/- 14 min to 18 min +/- 8.9 min ( t  = 5.9,  p  = .004). Linear mixed modeling across sessions revealed that ISI ( B  = 11.0,  SE  = 0.94,  p  < .001), QIDS ( B  = 11.3,  SE  = 0.96,  p  < .001), and MFI ( B  = 30.0,  SE  = 4.4,  p  < .001) improved across treatment. Daily sleep diaries showed decreased wake during the night ( B  = 22.8,  SE  = 7.19,  p  = .008), increased sleep time ( B  = 382.4,  SE  = 71.89,  p  < .001), and increased quality of sleep ( B  = 3.7,  SE  = 0.37,  p  < .001). When asked whether group members would recommend this group, 27% responded ""yes"" and 73% responded ""definitely yes.""  Conclusions:  Additional controlled studies utilizing sleep-focused therapy in depressed adolescents with insomnia are warranted.",2019,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","['adolescents with major depressive disorder (MDD) and insomnia', 'Adolescents with MDD (n = 16; mean age = 17.3 ', 'insomnia (CBTI', 'depressed adolescents with insomnia', 'Depressed Adolescents']","['Modified Cognitive Behavioral Therapy', 'modified-group cognitive behavioral therapy', 'yes"" and 73% responded ""definitely yes']","['Daily sleep diaries', 'sleep onset latency', ""Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score"", 'increased sleep time', 'QIDS', 'MFI', 'Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI', 'quality of sleep']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}]",,0.0345799,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","[{'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Czopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Dore-Stites', 'Affiliation': 'Pediatric Behavioral Development, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Dopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Roseanne', 'Initials': 'R', 'LastName': 'Armitage', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Hoban', 'Affiliation': 'Pediatric Sleep Medicine and Clinical Neurophysiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}]",Behavioral sleep medicine,['10.1080/15402002.2017.1299737']
1578,31577867,Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.,"OBJECTIVE


To analyze the effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with major depressive disorder (MDD) based on pooled data from 4 short-term studies and 1 long-term extension study.
METHODS


The short-term studies (June 2011 to November 2016) were randomized, double-blind, placebo-controlled studies in outpatients with MDD (DSM-IV-TR criteria) and inadequate response to 1-3 prior antidepressant treatments (ADTs) plus 1 prospective ADT. Patients were randomized to adjunctive brexpiprazole (fixed or flexible doses in the range of 1-3 mg/d; n = 1,032) or placebo (n = 819) for 6 weeks. The long-term study (October 2011 to May 2017) was a 52-week (amended to 26 weeks), open-label, uncontrolled study of adjunctive brexpiprazole 0.5-3 mg/d (flexible dose; n = 2,938). Mean changes from baseline and categorical shifts in fasting metabolic parameters (cholesterol, triglycerides, and glucose) and body weight were analyzed.
RESULTS


Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment. In most cases, the incidence of unfavorable shifts in metabolic parameters was lower than the incidence of favorable shifts. Mean body weight increase at last visit in the short-term studies was 1.5 kg with ADT + brexpiprazole and 0.3 kg with ADT + placebo. During long-term treatment, mean body weight increased by 3.8 kg over 58 weeks.
CONCLUSIONS


Adjunctive brexpiprazole was associated with small changes in metabolic parameters and moderate weight gain during short- and long-term treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT01360866.",2019,"Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment.","['Patients With Major Depressive Disorder Treated With', 'outpatients with MDD (DSM-IV-TR criteria) and inadequate response to 1-3 prior antidepressant treatments (ADTs) plus 1 prospective ADT', 'adults with major depressive disorder (MDD']","['ADT + brexpiprazole', 'ADT + placebo', 'placebo', 'adjunctive brexpiprazole', 'Adjunctive Brexpiprazole']","['metabolic parameters and moderate weight gain', 'fasting metabolic parameters (cholesterol, triglycerides, and glucose) and body weight', 'mean body weight', 'metabolic parameters and body weight', 'Mean body weight increase', 'Metabolic Parameters and Body Weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0464562,"Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind South Florida, 7205 Corporate Center Dr, Ste 200, Miami, FL 33126. jnewcomer@thrivingmind.org.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eriksson', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Meehan', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12680']
1579,32414347,"The PAPHIO study protocol: a randomised controlled trial with a 2 x 2 crossover design of physical activity adherence, psychological health and immunological outcomes in breast cancer survivors.","BACKGROUND


The PAPHIO study; a randomized controlled trial with 2X2 crossover design will implement a self-directed physical activity program in which participants will engage in self-monitoring and receive motivational interviewing to enhance physical activity adherence. The study aims to determine the effects of 24 weeks self-directed activity combined with motivational interviewing (MI) on (i) psychological health, (ii) quality of life (QoL) and (iii) immune function in female breast cancer survivors.
METHODS


The study will recruit 64 female breast cancer survivors within 3 years of diagnosis and at least 6 months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia. They will be randomly allocated to immediate intervention (IIG group) or delayed intervention groups (DIG group) in a 1:1 ratio. All participants will be given a wearable device (Fitbit Alta HR) and undertake self-directed physical activity for 24 weeks and will receive MI for 12 weeks (IIG; during week 0 to week 12 and DIG; during week 13 to week 24). Participants' daily step count and the changes of immune cell functionality will be assessed at the beginning (week 1: T1), week 12 (T2) and week 24 (T3) of the program. Physical activity adherence will be assessed at T2 and T3. Participants will also complete four questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B) at three time points (T1 to T3). Linear-mixed models will be used to assess the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy at T1, T2 and T3;between 2 groups.
DISCUSSION


We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
TRIAL REGISTRATION


Australian New Zealand Clinical trials Registry- ACTRN12619001271190. Prospectively registered on 13 September 2019.",2020,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","['Prospectively registered on 13 September 2019', 'breast cancer survivors', 'female breast cancer survivors', '64 female breast cancer survivors within 3\xa0years of diagnosis and at least 6\xa0months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia']","['physical activity intervention', 'immediate intervention (IIG group) or delayed intervention', 'physical activity adherence, psychological health', 'Registry', 'motivational interviewing', '24\u2009weeks self-directed activity combined with motivational interviewing (MI', 'self-directed physical activity program']","['Physical activity adherence', 'physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy', 'i) psychological health, (ii) quality of life (QoL) and (iii) immune function', 'questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B', 'immune cell functionality', 'physical activity adherence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0682482,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","[{'ForeName': 'Supa', 'Initials': 'S', 'LastName': 'Pudkasam', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. supa.pudkasam@live.vu.edu.au.'}, {'ForeName': 'Meron', 'Initials': 'M', 'LastName': 'Pitcher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Connor"", 'Affiliation': 'IPC Health Altona Meadows, Melbourne, VIC, Australia.'}, {'ForeName': 'Nanthaphan', 'Initials': 'N', 'LastName': 'Chinlumprasert', 'Affiliation': 'Bernadette de Lourdes School of Nursing Science, Assumption University, Bangkok, Thailand.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Stojanovska', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Vasso', 'Initials': 'V', 'LastName': 'Apostolopoulos', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. vasso.apostolopoulos@vu.edu.au.'}]",BMC public health,['10.1186/s12889-020-08827-x']
1580,31476615,Teachers' nonverbal behaviors influence children's stereotypic beliefs.,"The current research tested whether differences in teachers' nonverbal behaviors influence children's intergroup attitudes and stereotypic beliefs. In this study, 5- to 8-year-old participants (N = 96) were assigned to novel groups (marked by T-shirt color) and then viewed interactions between teachers and pairs of students who were also members of the novel groups. Across four interactions, the teacher directed positive nonverbal behaviors toward students from one group and directed negative nonverbal behaviors toward students from another group. After viewing the interactions, participants were presented with pairs of new students from the two novel groups and were asked three types of test questions. When participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership. However, when asked who they would like to befriend, only participants who were assigned to the group that received positive behaviors selected ingroup members. On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance. This study shows that teachers' nonverbal behaviors may be one source of children's academic stereotypes, including negative stereotypes about groups to which they belong. Moreover, these findings highlight the importance of subtle social cues in guiding children's beliefs about social groups.",2019,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","['participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership', '5- to 8-year-old participants (N\u202f=\u202f96']",[],"[""Teachers' nonverbal behaviors influence children's stereotypic beliefs""]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",4.0,0.0412505,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brey', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA. Electronic address: elbrey@hawaii.edu.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pauker', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA.""}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104671']
1581,30835643,A Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Regular Methamphetamine Use in Methadone Treatment.,"This study evaluated the efficacy of brief cognitive behavioral therapy (BCBT) for regular methamphetamine use among methadone-maintained women. A randomized controlled trial was conducted in four methadone treatment services. Eligible women were assigned to receive either BCBT or drug education. Five questionnaires were used to assess the research hypotheses at weeks 0, 4, and 12. Urinalysis was used to verify self-reported methamphetamine use at week 0. Urinalyses were used for those participants who reported abstinence from methamphetamine at weeks 4 and 12. Overall, 120 women were enrolled. Sixteen participants were lost to follow-up. Compared with the control group, the treatment group showed significant reductions in frequency of methamphetamine use ( p  < 0.001), severity of methamphetamine dependence ( p  < 0.001), and number of days of methamphetamine use ( p  < 0.001) at weeks 4 and 12. Significant improvements in readiness to change ( p  < 0.001), psychological well-being ( p  < 0.001), and social functioning ( p  = 0.001) were found in the treatment group at weeks 4 and 12. Nineteen urine specimens (31.66%) in the treatment group were negative for methamphetamine use at post-treatment and follow-up, while no change was found in the control group (0.00%). The study supported the efficacy of BCBT for methamphetamine use and associated harms.",2019,"Significant improvements in readiness to change (p < 0.001), psychological well-being (p < 0.001), and social functioning (p = 0.001) were found in the treatment group at weeks 4 and 12.","['120 women were enrolled', 'methadone-maintained women', 'Eligible women', 'Sixteen participants were lost to follow-up']","['BCBT', 'Cognitive Behavioral Therapy', 'BCBT or drug education', 'cognitive behavioral therapy (BCBT', 'methamphetamine']","['frequency of methamphetamine use', 'social functioning', 'severity of methamphetamine dependence', 'negative for methamphetamine use', 'number of days of methamphetamine use']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",120.0,0.05497,"Significant improvements in readiness to change (p < 0.001), psychological well-being (p < 0.001), and social functioning (p = 0.001) were found in the treatment group at weeks 4 and 12.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Alammehrjerdi', 'Affiliation': 'a Program of International Research and Training, National Drug and Alcohol Research Centre, School of Public Health and Community Medicine, University of New South Wales , Sydney , Australia.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Briggs', 'Affiliation': 'b Stats Central, Mark Wainwright Analytical Centre, University of New South Wales , Sydney , Australia.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Biglarian', 'Affiliation': 'c Department of Biostatistics, Social Determinants of Health Research Center, University of Social Welfare and Rehabilitation Sciences , Tehran , Iran.'}, {'ForeName': 'Azarakhsh', 'Initials': 'A', 'LastName': 'Mokri', 'Affiliation': 'd Iranian National Centre for Addiction Studies, Tehran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Dolan', 'Affiliation': 'a Program of International Research and Training, National Drug and Alcohol Research Centre, School of Public Health and Community Medicine, University of New South Wales , Sydney , Australia.'}]",Journal of psychoactive drugs,['10.1080/02791072.2019.1578445']
1582,32414331,"Patient information, communication and competence empowerment in oncology (PIKKO) - evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial.","BACKGROUND


Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain no access to it. Accordingly, there is a need for a single point of contact that can provide advice, information and assistance. In the state of Saarland, Germany, a supportive new consulting and information path (PIKKO) for all types of cancer is currently evaluated by the German Cancer Society, the Cancer Society of the Saarland, three statutory health insurances and the Jena University Hospital. PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work. This methodical work presents the process and analysis planning of this evaluation.
METHODS


The study population includes all cancer types, both new and existing diseases. PIKKO (with patient navigator, oncological knowledge database, specialized oncological counseling) is evaluated within a controlled, non-randomized, comparative, multicenter, longitudinal design. In addition to patient surveys, data from statutory health insurances and utilization data from the web database are collected, and interviews with patient navigators and doctors are carried out. Patients are assigned to a control (usual care) or an intervention group (u. c. + PIKKO). Primary outcome is the health related quality of life (SF-12) six months after baseline. Secondary outcomes are self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A). Furthermore, the time course of direct costs of medical care (e.g. work disability days) and usage data of the intervention modules are analyzed. Among other statistical procedures, we use t-tests, univariate tests and growth curve models.
DISCUSSION


If PIKKO proves to be effective, recommendations can be made to health organizations, which should lead to the concept being rolled out throughout Germany and included into oncological guidelines. We expect PIKKO to be a useful addition to usual cancer care, helping to improve the quality of life of cancer patients and reduce healthcare costs.
TRIAL REGISTRATION


This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, the reason for the delay was the prioritization of the study management in the first year to establish the new approach into practice). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.",2020,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","['Cancer patients', 'overall oncological patients']",['supportive care intervention'],"['quality of life, self-efficacy, health literacy and patient satisfaction', 'health related quality of life (SF-12', 'self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0946291,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Schneider', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany. nico.schneider@med.uni-jena.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bäcker', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keinki', 'Affiliation': 'German Cancer Society, Kuno-Fischer-Strasse 8, 14057, Berlin, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hübner', 'Affiliation': 'Department of Hematology and Medical Oncology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Brandt', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'von der Winkel', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': 'ze:roPraxen, Bodelschwinghstrasse 10/3, 68723, Schwetzingen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}]",BMC medical research methodology,['10.1186/s12874-020-01002-1']
1583,31576471,Psychoeducational group intervention for breast cancer survivors: a non-randomized multi-center pilot study.,"PURPOSE


The aim of the study was to evaluate an outpatient psychoeducational group program for breast cancer patients aimed to improve various psychosocial parameters, enhancing the patients' competence and reducing fear of recurrence.
METHODS


The study is based on a multi-center, non-randomized control group design with three measurement time points (T1 baseline, T2 end of the intervention, T3 6-week follow-up). Breast cancer patients were assessed with various standardized questionnaires including fear of progression, self-efficacy, depression, and quality of life.
RESULTS


A total of 50 breast cancer patients participated (intervention group n = 27, control group n = 23). The results show a significant reduction in the fear of progression/recurrence (FoPR) (p = 0.003) and a significant increase in self-efficacy (SE) (p = 0.007) for the intervention group with a large (FoPR, Eta 2  = .178) and medium (SE, Eta 2  = .113) effect size, respectively. For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
CONCLUSIONS


The psychoeducational program has been proven to be effective for breast cancer survivors, but further investigation based on a randomized trial is necessary.
PRACTICE IMPLICATIONS


To improve participation rate assessment of patient's needs and close cooperation with rehabilitation centers, psychosocial counseling services, and medical oncologists are recommended.",2020,"For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
","['50 breast cancer patients participated (intervention group n\u2009=\u200927, control group n\u2009=\u200923', 'breast cancer patients', 'breast cancer survivors', 'Breast cancer patients']","['outpatient psychoeducational group program', 'Psychoeducational group intervention']","['self-efficacy (SE', 'fear of progression/recurrence (FoPR', 'fear of recurrence', 'fear of progression, self-efficacy, depression, and quality of life', 'depressive symptoms, social support, or quality of life']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0037438'}]",50.0,0.0215598,"For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
","[{'ForeName': 'Joachim B', 'Initials': 'JB', 'LastName': 'Weis', 'Affiliation': 'Comprehensive Cancer Center Department of Cancer Self-Help Research, Medical Center University Freiburg, Hugstetter Str. 49, 79106, Freiburg, Germany. joachim.weis@uniklinik-freiburg.de.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Gschwendtner', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Giesler', 'Affiliation': 'Institute of Medical Biometry und Statistics, Section of Health Services Research and Rehabilitation Research, Medical Center University Freiburg, Breisgau, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'Department of Public Health and Education, University of Education, Freiburg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Wirtz', 'Affiliation': 'Department of Research Methods, University of Education, Freiburg, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05076-6']
1584,27956565,Randomized placebo-controlled study of lovastatin in children with neurofibromatosis type 1.,"OBJECTIVE


To assess the efficacy of lovastatin on visuospatial learning and attention for treating cognitive and behavioral deficits in children with neurofibromatosis type 1 (NF1).
METHODS


A multicenter, international, randomized, double-blind, placebo-controlled trial was conducted between July 2009 and May 2014 as part of the NF Clinical Trials Consortium. Children with NF1 aged 8-15 years were screened for visuospatial learning or attention deficits (n = 272); 146 children demonstrated deficits at baseline and were randomly assigned to lovastatin (n = 74; 40 mg/d) or placebo (n = 70). Treatment was administered once daily for 16 weeks. Primary outcomes were total errors on the Cambridge Neuropsychological Test Automated Battery Paired Associate Learning task (visuospatial learning) and the Score subtest from the Test of Everyday Attention for Children (sustained attention). Secondary outcomes measured executive function, attention, visuospatial skills, behavior, and quality of life. Primary analyses were performed on the intention-to-treat population.
RESULTS


Lovastatin had no significant effect on primary outcomes after 16 weeks of treatment: visuospatial learning (Cohen d = -0.15, 95% confidence interval -0.47 to 0.18) or sustained attention (Cohen d = 0.19, 95% confidence interval -0.14 to 0.53). Lovastatin was well tolerated, with no increase in reported adverse events compared to placebo.
CONCLUSIONS


Lovastatin administered once daily for 16 weeks did not improve visuospatial learning or attention in children with NF1 and is not recommended for amelioration of cognitive deficits in this population.
CLINICALTRIALSGOV IDENTIFIER


This study was registered at ClinicalTrials.gov (NCT00853580) and Australian New Zealand Clinical Trials Registry (ACTRN12607000560493).
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for children with NF1, lovastatin does not improve visuospatial learning or attention deficits.",2016,"CONCLUSIONS


Lovastatin administered once daily for 16 weeks did not improve visuospatial learning or attention in children with NF1 and is not recommended for amelioration of cognitive deficits in this population.
","['children with neurofibromatosis type 1 (NF1', 'children with NF1', 'July 2009 and May 2014 as part of the NF Clinical Trials Consortium', 'children with neurofibromatosis type 1', 'Children with NF1 aged 8-15 years were screened for visuospatial learning or attention deficits (n = 272); 146 children demonstrated deficits at baseline']","['Lovastatin', 'lovastatin', 'placebo']","['executive function, attention, visuospatial skills, behavior, and quality of life', 'sustained attention', 'intention-to-treat population', 'adverse events', 'visuospatial learning', 'visuospatial learning or attention deficits', 'visuospatial learning and attention for treating cognitive and behavioral deficits', 'total errors on the Cambridge Neuropsychological Test Automated Battery Paired Associate Learning task (visuospatial learning) and the Score subtest from the Test of Everyday Attention for Children (sustained attention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027831', 'cui_str': 'Peripheral Neurofibromatosis'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0585653', 'cui_str': 'Test of Everyday Attention'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.755755,"CONCLUSIONS


Lovastatin administered once daily for 16 weeks did not improve visuospatial learning or attention in children with NF1 and is not recommended for amelioration of cognitive deficits in this population.
","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Ullrich', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cantor', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Stephen J C', 'Initials': 'SJ', 'LastName': 'Hearps', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Tena', 'Initials': 'T', 'LastName': 'Rosser', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Walsh', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Gioia', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Wolters', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonsgard', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schorry', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Viskochil', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Klesse', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gutmann', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Alcino J', 'Initials': 'AJ', 'LastName': 'Silva', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Hunter', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Celiane', 'Initials': 'C', 'LastName': 'Rey-Casserly', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Cantor', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Anna W', 'Initials': 'AW', 'LastName': 'Byars', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Stavinoha', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Ackerson', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Armstrong', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Isenberg', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': ""O'Neil"", 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Packer', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Korf', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Acosta', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston.""}, {'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'North', 'Affiliation': ""From the Murdoch Children's Research Institute (J.M.P., S.J.C.H., K.N.N.), Royal Children's Hospital; Department of Paediatrics (J.M.P., K.N.N.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Children's Hospital Education Research Institute (B.B.), Children's Hospital at Westmead; Discipline of Paediatrics and Child Health (B.B.), University of Sydney, Australia; Department of Neurology (N.J.U., C.R.-C.), Boston Children's Hospital, MA; Department of Preventative Medicine (A.C.), School of Public Health (G.C.), Department of Psychology (J.D.A.), and Department of Genetics (B.K.), University of Alabama at Birmingham; Department of Neurology (T.R., S.H.O.), Children's Hospital of Los Angeles, CA; Center for Neuroscience and Behavioral Medicine (K.S.W., G.A.G., R.J.P., M.T.A.), Children's National Health System, Washington, DC; Pediatric Oncology Branch Center for Cancer Research (P.L.W.), National Cancer Institute, Bethesda, MD; Division of Neurology (J.T., S.J.H.), University of Chicago Medicine Comer Children's Hospital, IL; Human Genetics (E.S.) and Division of Neurology (A.W.B.), Cincinnati Children's Hospital Medical Center, OH; Department of Genetics (D.V.), University of Utah, Salt Lake City; Department of Pediatrics (L.K.), University of Texas Southwestern Medical Center, Dallas; Division of Oncology (M.F., C.L.A.), Children's Hospital of Philadelphia, PA; Department of Neurology (D.H.G., J.I.), Washington University School of Medicine in St Louis, MO; Gonda Neuroscience and Genetics Center (A.J.S.), University of California Los Angeles; Primary Children's Hospital (N.L.C.), Salt Lake City, UT; and University of Texas MD Anderson Cancer Center (P.L.S.), Houston. kathryn.north@mcri.edu.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,[]
1585,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dysthymic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637']
1586,31574029,"A Randomized, Controlled Pilot Trial Comparing Platelet-Rich Plasma to Topical Minoxidil Foam for Treatment of Androgenic Alopecia in Women.","BACKGROUND


Androgenic alopecia (AGA) is a common hair loss disorder. Studies have demonstrated successful treatment with platelet-rich plasma (PRP) in men, but studies in women are few.
OBJECTIVE


To evaluate PRP in the treatment of AGA in women, compared with topical minoxidil.
MATERIALS AND METHODS


Twenty women with AGA received topical minoxidil for 12 weeks and injectable PRP for 12 weeks in a randomized crossover design with an 8-week washout between treatments. Standardized TrichoScan analysis and quality-of-life questionnaires were assessed at baseline and 12-week follow-up for each treatment.
RESULTS


After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred. However, minoxidil resulted in significant increases in hair count (p < .001), vellus hair density (p = .03), terminal hair density (p = .004), and cumulative thickness (p = .004). Several quality of life responses improved from baseline to Week 12 after PRP treatment, whereas no improvements were noted after minoxidil.
CONCLUSION


Platelet-rich plasma is an effective treatment for hair regrowth in female AGA, although not as effective as minoxidil. However, the improved quality of life responses after PRP, but not minoxidil, suggest a potential overall greater degree of satisfaction with PRP.
LEVELS OF EVIDENCE


I.
CLINICAL TRIAL REGISTRATION


NCT03488108.",2020,"After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred.","['Twenty women with AGA received', 'Androgenic Alopecia in Women']","['topical minoxidil', 'minoxidil', 'Platelet-Rich Plasma to Topical Minoxidil Foam', 'injectable PRP']","['vellus hair density', 'quality of life responses', 'hair count', 'terminal hair density', 'cumulative thickness', 'Standardized TrichoScan analysis and quality-of-life questionnaires', 'Several quality of life responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0034380'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0221960', 'cui_str': 'Structure of terminal hair'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",20.0,0.0624348,"After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred.","[{'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Bruce', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Thais P', 'Initials': 'TP', 'LastName': 'Pincelli', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Heckman', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Cheryl M', 'Initials': 'CM', 'LastName': 'Desmond', 'Affiliation': 'Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Arthurs', 'Affiliation': 'Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Nancy N', 'Initials': 'NN', 'LastName': 'Diehl', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Douglass', 'Affiliation': 'Departments of Cardiovascular Medicine.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Bruce', 'Affiliation': 'Departments of Cardiovascular Medicine.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Shapiro', 'Affiliation': 'Orthopedic Surgery, Mayo Clinic, Jacksonville, Florida.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002168']
1587,32413383,Cost-effectiveness of adding fluoride varnish to a preventive protocol for early childhood caries in rural children with no access to fluoridated drinking water.,"OBJECTIVES


Evidence of the cost-effectiveness of fluoride varnish in the prevention of caries is not yet fully conclusive. The aim of this study was to assess the incremental cost-effectiveness ratio (ICER) of the community-wide application of fluoride varnish in the prevention of early childhood caries (ECC) in non-fluoridated areas.
MATERIALS AND METHODS


A cost-effectiveness analysis was carried out based on a clinical decision tree from the payer's perspective. The effectiveness and cost of the varnish were determined from a two-year follow-up triple-blind randomized control trial in 275 two- to three-year-old children. Costs and benefits were discounted at 3% per year. Only direct costs were evaluated, expressed in Chilean pesos (CLP) valued in July, 2019 (exchange rate USD = CLP686.06). A univariate deterministic sensitivity analysis was carried out.
RESULTS


Incidence of ECC was 45 % for the varnish group and 55.6 % for the placebo group with a two-year follow-up. The weighted cost to intervene and treat the consequences of ECC was CLP 67,757 (USD98.76) for the fluoride varnish and CLP 67,739 (USD98.74) for the control group. The ICER was CLP 173 (USD0.25) for each extra healthy child in favor of fluoride varnish. The sensitivity analysis showed that the increase in caries was the variable which most influenced the ICER.
CONCLUSIONS


The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
CLINICAL SIGNIFICANCE


Findings support the application of fluoride varnish as a cost-effective community strategy to prevent ECC in non-fluoridated areas.",2020,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","['rural children with no access to fluoridated drinking water', '275 two- to three-year-old children', 'early childhood caries (ECC) in non-fluoridated areas']","['fluoride varnish', 'placebo']","['Cost-effectiveness', 'Costs and benefits', 'caries', 'incremental cost-effectiveness ratio (ICER', 'Incidence of ECC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]",,0.119731,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zaror', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile. Electronic address: carlos.zaror@ufrontera.cl.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz-Millán', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: patricia.munoz@ufrontera.cl.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Espinoza-Espinoza', 'Affiliation': 'Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Department of Public Health, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile. Electronic address: gerardo.espinoza@ufrontera.cl.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vergara-González', 'Affiliation': 'Aysén Health Service, Coyhaique, Chile. Electronic address: carovergarag@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Martínez-Zapata', 'Affiliation': 'Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: MMartinezz@santpau.cat.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103374']
1588,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE


Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment.
METHOD


Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms.
RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376']
1589,32414376,Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial.,"BACKGROUND


In addition to delivering vital health care to millions of patients in the United States, community health centers (CHCs) provide needed health insurance outreach and enrollment support to their communities. We developed a health insurance enrollment tracking tool integrated within the electronic health record (EHR) and conducted a hybrid implementation-effectiveness trial in a CHC-based research network to assess tool adoption using two implementation strategies.
METHODS


CHCs were recruited from the OCHIN practice-based research network. Seven health center systems (23 CHC clinic sites) were recruited and randomized to receive basic educational materials alone (Arm 1), or these materials plus facilitation (Arm 2) during the 18-month study period, September 2016-April 2018. Facilitation consisted of monthly contacts with clinic staff and utilized audit and feedback and guided improvement cycles. We measured total and monthly tool utilization from the EHR. We conducted structured interviews of CHC staff to assess factors associated with tool utilization. Qualitative data were analyzed using an immersion-crystallization approach with barriers and facilitators identified using the Consolidated Framework for Implementation Research.
RESULTS


The majority of CHCs in both study arms adopted the enrollment tool. The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01). However, by the end of the study period, the rate of tool utilization was similar in both arms; and observed between-arm differences in tool utilization were largely driven by a single, large health center in Arm 2. Perceived relative advantage of the tool was the key factor identified by clinic staff as driving tool utilization. Implementation climate and leadership engagement were also associated with tool utilization.
CONCLUSIONS


Using basic education materials and low-intensity facilitation, CHCs quickly adopted an EHR-based tool to support critical outreach and enrollment activities aimed at improving access to health insurance in their communities. Though facilitation carried some benefit, a CHC's perceived relative advantage of the tool was the primary driver of decisions to implement the tool.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02355262, Posted February 4, 2015.",2020,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","['Seven health center systems (23 CHC clinic sites', 'CHCs were recruited from the OCHIN practice-based research network']","['health insurance enrollment tracking tool integrated within the electronic health record (EHR', 'basic educational materials alone']",['rate of tool utilization'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.135831,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","[{'ForeName': 'Brigit', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA. adamusb@ohsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tillotson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Huguet', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Marino', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Sumic', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'E DeVoe', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}]",BMC health services research,['10.1186/s12913-020-05317-z']
1590,31567609,"1550-nm Nonablative Fractional Laser Versus 10,600-nm Ablative Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy and Treatment Regimen.","BACKGROUND


The appearance and symptoms of scars can cause significant distress to patients.
OBJECTIVE


To assess and compare efficacy of the 1,500-nm nonablative fractional laser (NAFL) and 10,600-nm ablative fractional laser (AFL) in reducing symptoms and improving the appearance of traumatic or surgical scars.
MATERIALS AND METHODS


Single-center prospective, randomized, blinded, split-scar study was conducted on 100 patients with a scar obtained through trauma or surgery. Three treatments of NAFL or AFL were administered to each half of the scar at 4-week intervals. Scars were self-rated by the patient using the Patient and Observer Scar Assessment Scale and a satisfaction score and objectively evaluated by blinded dermatologists using the Manchester Scar Scale and visual analog scale.
RESULTS


Blinded observers found no statistically significant difference in scar appearance. Patient rating showed improvement of scar appearance (p < .0001). Pain was worse after treatment with AFL (p = .0492). Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
CONCLUSION


Scar treatment with AFL or NAFL is associated with high patient satisfaction. Objective evaluation of scars did not identify improvement in scar appearance.",2020,"Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
","['Surgical and Traumatic Scars', '100 patients with a scar obtained through trauma or surgery']","['NAFL or AFL', '1,500-nm nonablative fractional laser (NAFL) and 10,600-nm ablative fractional laser (AFL', 'AFL or NAFL', 'AFL', '1550-nm Nonablative Fractional Laser Versus 10,600-nm Ablative Fractional Laser']","['scar appearance', 'Pain', 'Observer Scar Assessment Scale and a satisfaction score and objectively evaluated by blinded dermatologists using the Manchester Scar Scale and visual analog scale']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036282', 'cui_str': 'Traumatic scar'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",100.0,0.0435432,"Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Chitgopeker', 'Affiliation': 'Medical Dermatology Associates of Chicago, Chicago, Illinois.'}, {'ForeName': 'Lainee', 'Initials': 'L', 'LastName': 'Goettsche', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landherr', 'Affiliation': 'Forefront Dermatology, Cedar Rapids, Iowa.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Loyola Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Johnson-Jahangir', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Nkanyezi', 'Initials': 'N', 'LastName': 'Ferguson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'VanBeek', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002152']
1591,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1592,31353040,Predicting Early Emergence of Childhood Obesity in Underserved Preschoolers.,"OBJECTIVE


To determine the magnitude of risk of factors that contribute to the emergence of childhood obesity among low-income minority children.
STUDY DESIGN


We conducted a prospective cohort analysis of parent-child pairs with children aged 3-5 years who were nonobese (n = 605 pairs) who participated in a 3-year randomized controlled trial of a healthy lifestyle behavioral intervention. After baseline, height and weight were measured 5 times over 3 years to calculate body mass index (BMI) percentiles and classify children as normal, overweight, or obese. Multivariable logistic regression was used to estimate the odds of obesity after 36 months. Predictors included age, sex, birth weight, gestational age, months of breastfeeding, ethnicity, baseline child BMI, energy intake, physical activity, food security, parent baseline BMI, and parental depression.
RESULTS


Among this predominantly low-income minority population, 66% (398/605) of children were normal weight at baseline and 34% (n = 207/605) were overweight. Among normal weight children at baseline, 24% (85/359) were obese after 36 months; among overweight children at baseline, 55% (n = 103/186) were obese after 36 months. Age at enrollment (OR 2.11, 95% CI 1.64-2.72), child baseline BMI (OR 3.37, 95% CI 2.51-4.54), and parent baseline BMI (OR for a 6-unit change 1.36, 95% CI 1.09-1.70) were significantly associated with the odds of becoming obese for children.
CONCLUSIONS


The combination of child age, parent BMI, and child overweight as predictors of child obesity suggest a paradigm of family-centered obesity prevention beginning in early childhood, emphasizing the relevance of child overweight as a phenotype highly predictive of child obesity.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT01316653.",2019,"Age at enrollment (OR 2.11, 95% CI 1.64-2.72), child baseline BMI (OR 3.37, 95% CI 2.51-4.54), and parent baseline BMI (OR for a 6-unit change 1.36, 95% CI 1.09-1.70) were significantly associated with the odds of becoming obese for children.
","['parent-child pairs with children aged 3-5\xa0years who were nonobese (n\xa0=\xa0605 pairs', 'normal weight children at baseline, 24% (85/359) were obese after 36\xa0months; among overweight children at baseline, 55% (n\xa0=\xa0103/186) were obese after 36\xa0months', 'low-income minority children', 'predominantly low-income minority population, 66% (398/605) of children were normal weight at baseline and 34% (n\xa0=\xa0207/605) were overweight', 'Underserved Preschoolers']",['healthy lifestyle behavioral intervention'],"['height and weight', 'age, sex, birth weight, gestational age, months of breastfeeding, ethnicity, baseline child BMI, energy intake, physical activity, food security, parent baseline BMI, and parental depression', 'child baseline BMI']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",605.0,0.0812287,"Age at enrollment (OR 2.11, 95% CI 1.64-2.72), child baseline BMI (OR 3.37, 95% CI 2.51-4.54), and parent baseline BMI (OR for a 6-unit change 1.36, 95% CI 1.09-1.70) were significantly associated with the odds of becoming obese for children.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN. Electronic address: bill.heerman@vumc.org.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.06.031']
1593,32414368,Preparing for an orthopedic consultation using an eHealth tool: a randomized controlled trial in patients with hip and knee osteoarthritis.,"BACKGROUND


To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients' satisfaction.
METHODS


A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1-4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed.
RESULTS


No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (- 0.10, 0.12), conduct - 0.02 (- 0.12, 0.07) and information provision 0.02 (- 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (- 0.19 (- 0.37, - 0.002) and pain medication (- 0.30 (- 0.49, - 0.01)). We found no differences on other secondary outcomes.
CONCLUSIONS


An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
TRIAL REGISTRATION


Dutch Trial Register (trial number NTR6262). Registered 30 January 2017.",2020,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","['patients with hip and knee osteoarthritis', '286 patients with (suspicion of) hip or knee OA', ""patients with hip or knee osteoarthritis (OA) on patients' satisfaction""]","['educational eHealth tool to prepare their upcoming consultation (n\u2009=\u2009144) or usual care', 'stand-alone mobile and web-based educational intervention (eHealth tool']","[""Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale"", 'pain medication', 'negative beliefs regarding physical activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",286.0,0.118311,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","[{'ForeName': 'Aniek A O M', 'Initials': 'AAOM', 'LastName': 'Claassen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands. a.claassen@maartenskliniek.nl.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'Schers', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Vincent J J F', 'Initials': 'VJJF', 'LastName': 'Busch', 'Affiliation': 'Department of Orthopaedic Surgery, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Cornelia H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01130-0']
1594,32414398,Individuals living in an onchocerciasis focus and treated three-monthly with ivermectin develop fewer new onchocercal nodules than individuals treated annually.,"BACKGROUND


Little information is available on the effect of ivermectin on the third- and fourth-stage larvae of Onchocerca volvulus. To assess a possible prophylactic effect of ivermectin on this parasite, we compared the effects of different ivermectin regimens on the acquisition of onchocercal nodules.
METHODS


We analyzed data from a controlled randomized clinical trial of ivermectin conducted in the Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals. The number of nodules that appeared between the start and the end of the clinical trial was analyzed, using ANOVA and multivariable Poisson regressions, between four treatment arms: 150 µg/kg annually, 800 µg/kg annually, 150 µg/kg 3-monthly, and 800 µg/kg 3-monthly.
RESULTS


The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose). Poisson regression model, adjusting on subject's age and weight, initial number of nodules and intensity of O. volvulus infection in his village of residence, confirmed that the incidence of new nodules was reduced in 3-monthly treatment arms compared to annually treatment arms, and that the dosage of ivermectin does not seem to influence this effect. Furthermore, the number of newly acquired nodules was positively associated with the initial number of nodules. Analysis of disappearance of nodules did not show any significant difference between the treatment groups.
CONCLUSIONS


To our knowledge, these results suggest for the first time in humans, that ivermectin has a partial prophylactic effect on O. volvulus. Three-monthly treatment seems more effective than annual treatment to prevent the appearance of nodules.",2020,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,['Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals'],['ivermectin'],"['mean number of nodules', 'number of nodules']","[{'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0029001', 'cui_str': 'Infection by Onchocerca volvulus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}]",,0.060998,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,"[{'ForeName': 'Jérémy T', 'Initials': 'JT', 'LastName': 'Campillo', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Cédric B', 'Initials': 'CB', 'LastName': 'Chesnais', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Sébastien D S', 'Initials': 'SDS', 'LastName': 'Pion', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Gardon', 'Affiliation': 'Hydrosciences Montpellier, Institut de Recherche pour le Développement (IRD), Montpellier, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kamgno', 'Affiliation': 'Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), P.O. Box 5797, Yaoundé, Cameroon.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boussinesq', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France. michel.boussinesq@ird.fr.'}]",Parasites & vectors,['10.1186/s13071-020-04126-x']
1595,32414381,Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff.,"BACKGROUND


Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment.
METHODS


Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes.
RESULTS


Participants included 553 child care workers representing 56 centers (HL = 250 staff/28 centers, HF = 303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (- 1.3 min/day, 95% CI: - 3.0, 0.3 in HL; - 1.9 min/day, 95% CI: - 3.3, - 0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons.
CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers.
TRIAL REGISTRATION


Care2BWell: Worksite Wellness for Child Care (NCT02381938).",2020,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","['Centers and their child care staff', ""Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial"", 'child care staff', 'Participants included 553 child care workers representing 56 centers (HL\u2009=\u2009250 staff/28 centers, HF\u2009=\u2009303 staff/28 centers']","[""Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment"", 'Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach', 'worksite wellness intervention']","['biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health', ""Workers' physical activity"", 'moderate-to-vigorous physical activity', 'health behaviors']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0376243', 'cui_str': 'finances'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0874431,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA. linnan@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Falon T', 'Initials': 'FT', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, College of Public Heath, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00968-x']
1596,32414405,"""[Repeat] testing and counseling is one of the key [services] that the government should continue providing"": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.","BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.
METHODS


PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.
RESULTS


At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.
CONCLUSION


This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.",2020,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[""women's partners"", '820 HIV-negative pregnant and lactating women aged 18-49\u2009years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT', 'PRIMAL Study participants were enrolled from two antenatal care clinics', 'pregnant and lactating women in the PRIMAL study, Uganda', 'pregnant and lactating women', 'Pregnant and Lactating', 'Ugandan Women']","['enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24\u2009months post-partum', 'enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling', 'Repeat] testing and counseling', 'repeat standard post-test counseling']","['risk reduction, couple communication, and emotional support', 'understanding, faithfulness, mutual support and appreciation within their couple']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714360', 'cui_str': 'Counseling strategy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0739136,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink Mbazzi', 'Affiliation': 'Medical Research Council / Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, P.O. Box 49, Entebbe, Uganda. femke.bannink@mrcuganda.org.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08738-x']
1597,32414411,Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial.,"BACKGROUND


Early mobilization has been proven effective for patients in intensive care units (ICUs) to improve functional recovery. However, early mobilization of critically ill, often mechanically ventilated, patients is cumbersome because of the attachment to tubes, drains, monitoring devices and muscle weakness. A mobile treadmill with bodyweight support may help to initiate mobilization earlier and more effectively. The aim of this study is to assess the effectiveness of weight-supported treadmill training in critically ill patients during and after ICU stay on time to independent functional ambulation.
METHODS


In this randomized controlled trial, a custom-built bedside body weight-supported treadmill will be used and evaluated. Patients are included if they have been mechanically ventilated for at least 48 hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise. Exclusion criteria are language barriers, no prior walking ability, contraindications for physiotherapy or a neurological condition as reason for ICU admission. We aim to include 88 patients and randomize them into either the intervention or the control group. The intervention group will receive usual care plus bodyweight-supported treadmill training (BWSTT) daily. The BWSSTT consists of walking on a mobile treadmill while supported by a harness. The control group will receive usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises. In both groups, we will aim for a total of 40 minutes of physiotherapy treatment time every day in one or two sessions, as tolerated by the patient. The primary outcome is time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress. All measurements will be done by assessors who are blinded to the intervention on the regular wards until hospital discharge.
DISCUSSION


This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay. The results of this study contribute to a better understanding of the effectiveness of early physiotherapy interventions for critically ill patients.
TRIAL REGISTRATION


Dutch Trial Register (NTR) ID: NL6766. Registered at 1 December 2017.",2020,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"['patients in intensive care units (ICUs', 'critically ill patients during and after ICU stay', '88 patients and randomize them into either the intervention or the control group', 'critically ill patients', 'critically ill patients during and after ICU stay on time to independent functional ambulation', 'Patients are included if they have been mechanically ventilated for at least 48\u2009hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise']","['conventional physiotherapy', 'usual care plus bodyweight-supported treadmill training (BWSTT) daily', 'usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises', 'weight-supported treadmill training']","['time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0578715', 'cui_str': 'Does sit unsupported'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.130516,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"[{'ForeName': 'Robin C H', 'Initials': 'RCH', 'LastName': 'Kwakman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Juultje', 'Initials': 'J', 'LastName': 'Sommers', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care, Neurosciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands. m.vanderschaaf@amsterdamumc.nl.'}]",Trials,['10.1186/s13063-020-04333-y']
1598,32414425,Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.,"BACKGROUND


In clinical practice, temporary interruption of rheumatoid arthritis (RA) therapy is common for various reasons including side effects, non-compliance, or necessity for surgery. To characterize temporary interruptions of baricitinib and placebo-matched tablets in phase 3 studies of patients with moderate-to-severe rheumatoid arthritis (RA) and describe their impact on efficacy and safety.
METHODS


During 4 baricitinib phase 3 studies, investigators documented timing, reason, and duration of investigator-initiated temporary interruptions of study drug. In 2 studies, patients recorded RA symptoms in daily diaries for 12 weeks. Post hoc analyses investigated changes in symptom scores during interruptions and resumption of treatment. Interruptions were evaluated for reoccurrence of adverse events or laboratory abnormalities after retreatment.
RESULTS


Across the placebo-controlled studies, interruptions occurred in larger proportions of baricitinib- (2 mg, 18%; 4 mg, 18%) vs placebo-treated (9%) patients in only one study (bDMARD-inadequate responder patients, RA-BEACON). In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm (9%) of RA-BEGIN (vs methotrexate monotherapy or combination therapy), and proportions were similar for baricitinib (10%) and adalimumab (9%) in RA-BEAM. Adverse events were the most common reason for interruption, but their reoccurrence after drug restart was infrequent. Most interruptions lasted ≤ 2 weeks. Daily diaries indicated modest symptom increases during interruption with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes.
CONCLUSIONS


Consistent with its pharmacologic properties, brief interruptions of baricitinib during phase 3 studies were associated with minor increases in RA symptoms that resolved following retreatment. This analysis provides useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT01710358, NCT01711359, NCT01721057, NCT01721044.",2020,"Interruptions had no impact on long-term efficacy outcomes.
","['patients with rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA', 'patients with RA']","['baricitinib', 'baricitinib and placebo-matched tablets', 'adalimumab']","['Adverse events', 'long-term efficacy outcomes', 'efficacy and safety', 'RA symptoms', 'reoccurrence of adverse events or laboratory abnormalities', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.490948,"Interruptions had no impact on long-term efficacy outcomes.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Muscoloskeletal Biomedical Research Centre/Chapel Allerton Hospital, Chapeltown Rd, Leeds, LS7 4SA, UK. P.Emery@leeds.ac.uk.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beattie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Helt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.'}]",Arthritis research & therapy,['10.1186/s13075-020-02199-8']
1599,32414414,"Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Insomnia seriously affects people's normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney.
DESIGN


This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW.
DISCUSSION


The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.",2020,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
",['124 participants suffering from insomnia symptoms'],"['JTW or placebo', 'Jiao-tai-wan (JTW', 'JTW', 'placebo']","['mean change in the Pittsburgh Sleep Quality Index (PSQI', 'altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3849168', 'cui_str': 'jiao tai wan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]",124.0,0.462694,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
","[{'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Zhejiang Chinese Medical University, Binwen Road, Binjiang District, Zhejiang, 310053, Hangzhou, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Pharm, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'The 2nd Clinical College of Wenzhou Medical University, Chashan Higher Education Park, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Nengzhi', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'X-ray Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Haihuan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Sleep monitoring center, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Research Institute of China Academy of Chinese Medical Sciences, No.16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. yeren601@163.com.'}, {'ForeName': 'Zhengzhong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. wzyzz2008@126.com.'}]",Trials,['10.1186/s13063-020-04299-x']
1600,31908254,A randomised controlled trial of lidocaine infusion on post-operative opioid consumption in patients undergoing robotic colorectal surgery.,"INTRODUCTION


Intravenous lidocaine has been shown to have analgesic effects leading to a reduced post-operative opiate need, but this effect is still debated in various surgical populations. We investigated whether this effect could be demonstrated in robot-assisted colorectal surgery.
METHODS


A total of 60 adult patients undergoing robot-assisted colorectal surgery were randomly assigned to two groups in this prospective, double-blinded trial. The lidocaine group was treated with intravenous lidocaine. Treatment was initiated before induction of anaesthesia with a bolus of 1.5 mg/kg and immediately followed by infusion of 1.5 mg/kg/h continued until 2 h after end of surgery. The control group received placebo treatment with an equal volume and a dosing of 0.9% saline. The follow-up period was 72 h.
RESULTS


No significant difference between groups in the median cumulated morphine consumption at 24 and 72 h was observed. Nor were there any differences in pain score, use of antiemetics, time until flatus and/or defecation or length of hospital stay.
CONCLUSIONS


In this randomised, double-blinded, prospective study using intravenous lidocaine versus 0.9% saline in robot-assisted colorectal surgery, we found no significant difference in post-operative cumulated morphine consumption at 24 or at 72 h.
FUNDING


The study received funding from DASAIMs Forskningsinitiativ (2016) and DASAIMs Smerteforskningspris (2016).
TRIAL REGISTRATION


The trial is registered with EudraCT (2014-003466-25) and ClinicalTrials.gov (ID: NCT03044808).",2020,"Nor were there any differences in pain score, use of antiemetics, time until flatus and/or defecation or length of hospital stay.
","['patients undergoing robotic colorectal surgery', '60 adult patients undergoing robot-assisted colorectal surgery']","['lidocaine', 'placebo treatment with an equal volume and a dosing of 0.9% saline', 'EudraCT']","['pain score, use of antiemetics, time until flatus and/or defecation or length of hospital stay', 'median cumulated morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.665282,"Nor were there any differences in pain score, use of antiemetics, time until flatus and/or defecation or length of hospital stay.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Herzog', 'Affiliation': 'jan.herzog@rsyd.dk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': ''}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': ''}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Jensen', 'Affiliation': ''}]",Danish medical journal,[]
1601,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638']
1602,27214731,Population-Based Colonoscopy Screening for Colorectal Cancer: A Randomized Clinical Trial.,"IMPORTANCE


Although some countries have implemented widespread colonoscopy screening, most European countries have not introduced it because of uncertainty regarding participation rates, procedure-related pain and discomfort, endoscopist performance, and effectiveness. To our knowledge, no randomized trials on colonoscopy screening currently exist.
OBJECTIVE


To investigate participation rate, adenoma yield, performance, and adverse events of population-based colonoscopy screening in several European countries.
DESIGN, SETTING, AND POPULATION


A population-based randomized clinical trial was conducted among 94 959 men and women aged 55 to 64 years of average risk for colon cancer in Poland, Norway, the Netherlands, and Sweden from June 8, 2009, to June 23, 2014.
INTERVENTIONS


Colonoscopy screening or no screening.
MAIN OUTCOMES AND MEASURES


Participation in colonoscopy screening, cancer and adenoma yield, and participant experience. Study outcomes were compared by country and endoscopist.
RESULTS


Of 31 420 eligible participants randomized to the colonoscopy group, 12 574 (40.0%) underwent screening. Participation rates were 60.7% in Norway (5354 of 8816), 39.8% in Sweden (486 of 1222), 33.0% in Poland (6004 of 18 188), and 22.9% in the Netherlands (730 of 3194) (P < .001). The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation. Of the 12 574 participants undergoing colonoscopy screening, we observed 1 perforation (0.01%), 2 postpolypectomy serosal burns (0.02%), and 18 cases of bleeding owing to polypectomy (0.14%). Sixty-two individuals (0.5%) were diagnosed with colorectal cancer and 3861 (30.7%) had adenomas, of which 1304 (10.4%) were high-risk adenomas. Detection rates were similar in the proximal and distal colon. Performance differed significantly between endoscopists; recommended benchmarks for cecal intubation (95%) and adenoma detection (25%) were not met by 6 (17.1%) and 10 of 35 endoscopists (28.6%), respectively. Moderate or severe abdominal pain after colonoscopy was reported by 601 of 3611 participants (16.7%) examined with standard air insufflation vs 214 of 5144 participants (4.2%) examined with carbon dioxide (CO2) insufflation (P < .001).
CONCLUSIONS AND RELEVANCE


Colonoscopy screening entails high detection rates in the proximal and distal colon. Participation rates and endoscopist performance vary significantly. Postprocedure abdominal pain is common with standard air insufflation and can be significantly reduced by using CO2.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00883792.",2016,"The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation.","['Of 31\u202f420 eligible participants randomized to the colonoscopy group, 12\u202f574 (40.0%) underwent screening', 'Sixty-two individuals (0.5%) were diagnosed with colorectal cancer and 3861 (30.7%) had adenomas, of which 1304 (10.4%) were high-risk adenomas', 'Colorectal Cancer', '94\u202f959 men and women aged 55 to 64 years of average risk for colon cancer in Poland, Norway, the Netherlands, and Sweden from June 8, 2009, to June 23, 2014']","['Colonoscopy screening or no screening', 'colonoscopy screening']","['carbon dioxide (CO2) insufflation', 'Participation rates', 'Participation in colonoscopy screening, cancer and adenoma yield, and participant experience', 'adenoma detection', 'Participation rates and endoscopist performance', 'Postprocedure abdominal pain', 'Moderate or severe abdominal pain', 'Detection rates', 'cecal intubation', 'cecum intubation rate']","[{'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}]",94959.0,0.276968,"The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway2Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway 3Department of Epidemiology, Harvard T.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Kaminski', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway4Department of Gastroenterological Oncology, The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology and Medical Center for Postgraduate Education, War.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway2Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterological Oncology, The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology and Medical Center for Postgraduate Education, Warsaw, Poland.'}, {'ForeName': 'Ernst J', 'Initials': 'EJ', 'LastName': 'Kuipers', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA7Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA8Division of Health Sciences and Technology, Harvard-Massachusetts Institute of Technology.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'McFadden', 'Affiliation': 'Frontier Science Scotland, Kincraig, UK.'}, {'ForeName': 'Annike', 'Initials': 'A', 'LastName': 'Sunde', 'Affiliation': 'Frontier Science Scotland, Kincraig, UK.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway2Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway 3Department of Epidemiology, Harvard T.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lansdorp-Vogelaar', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Garborg', 'Affiliation': 'Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Rupinski', 'Affiliation': 'Department of Gastroenterological Oncology, The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology and Medical Center for Postgraduate Education, Warsaw, Poland.'}, {'ForeName': 'Manon C W', 'Initials': 'MC', 'LastName': 'Spaander', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bugajski', 'Affiliation': 'Department of Gastroenterological Oncology, The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology and Medical Center for Postgraduate Education, Warsaw, Poland.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Høie', 'Affiliation': 'Department of Medicine, Sørlandet Hospital, Arendal, Norway.'}, {'ForeName': 'Tryggvi', 'Initials': 'T', 'LastName': 'Stefansson', 'Affiliation': 'Department of Surgery, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hoff', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway13Department of Research and Development, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Hans-Olov', 'Initials': 'HO', 'LastName': 'Adami', 'Affiliation': 'Department of Health Management and Health Economy, University of Oslo, Oslo, Norway2Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway 3Department of Epidemiology, Harvard T.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2016.0960']
1603,32415211,Comparison of the use of opioids only and pregabalin add-on for the treatment of neuropathic pain in cervical myelopathy patients: a pilot trial.,"Among patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants were randomly assigned to one of the two study groups. The participants in one study group received opioids only, while those in the other group received opioids and pregabalin. Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group). The LANSS, neck pain, and arm pain scores in the pregabalin add-on group improved significantly compared with those in the opioid-only group after the first 4 weeks (p = 0.005, 0.001 and 0.035, respectively), but there was no significant difference between the two groups during the next 4 weeks (p = 0.615, 0.377 and 0.716, respectively). There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up. Adverse events were reported by four patients (20.0%) in the opioid-only group and five patients (26.3%) in the pregabalin add-on group (p = 0.716). However, over time, the occurrence of side effects and dropouts increased in the pregabalin add-on group. This exploratory pilot study suggests that pregabalin add-on treatment is more efficient than the use of opioids alone at the beginning of NP treatment in cervical myelopathy patients. However, prescribing pregabalin add-on treatment for more than four weeks should be done cautiously.",2020,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"['cervical myelopathy patients', 'patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants', 'Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group']","['opioids only and pregabalin', 'pregabalin', 'opioids', 'opioids and pregabalin']","['LANSS, neck pain, and arm pain scores', 'neuropathic pain', 'neck disability index and EuroQol-5Dimension scores', 'Adverse events']","[{'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.0383874,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"[{'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Spine Center, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. chungc@snu.ac.kr.'}, {'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-020-65108-8']
1604,32415885,"UV308 excimer lamp phototherapy for the treatment of alopecia areata: A randomized, self-controlled study.",,2020,Excimer lamp (e-lamp) therapy is a new long-wave monochromatic ultraviolet (UV)B phototherapy that only targets affected areas.,['alopecia areata'],"['UV308 excimer lamp phototherapy', 'Excimer lamp (e-lamp) therapy']",['Alopecia areata (AA'],"[{'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}]",,0.0169899,Excimer lamp (e-lamp) therapy is a new long-wave monochromatic ultraviolet (UV)B phototherapy that only targets affected areas.,"[{'ForeName': 'Pongpenn', 'Initials': 'P', 'LastName': 'Sirichotiyakul', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Jitlada', 'Initials': 'J', 'LastName': 'Meephansan', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Poonkiat', 'Initials': 'P', 'LastName': 'Suchonwanit', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12570']
1605,31563344,"Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial.","BACKGROUND


Nosocomial pneumonia due to antimicrobial-resistant pathogens is associated with high mortality. We assessed the efficacy and safety of the combination antibacterial drug ceftolozane-tazobactam versus meropenem for treatment of Gram-negative nosocomial pneumonia.
METHODS


We conducted a randomised, controlled, double-blind, non-inferiority trial at 263 hospitals in 34 countries. Eligible patients were aged 18 years or older, were undergoing mechanical ventilation, and had nosocomial pneumonia (either ventilator-associated pneumonia or ventilated hospital-acquired pneumonia). Patients were randomly assigned (1:1) with block randomisation (block size four), stratified by type of nosocomial pneumonia and age (<65 years vs ≥65 years), to receive either 3 g ceftolozane-tazobactam or 1 g meropenem intravenously every 8 h for 8-14 days. The primary endpoint was 28-day all-cause mortality (at a 10% non-inferiority margin). The key secondary endpoint was clinical response at the test-of-cure visit (7-14 days after the end of therapy; 12·5% non-inferiority margin). Both endpoints were assessed in the intention-to-treat population. Investigators, study staff, patients, and patients' representatives were masked to treatment assignment. Safety was assessed in all randomly assigned patients who received study treatment. This trial was registered with ClinicalTrials.gov, NCT02070757.
FINDINGS


Between Jan 16, 2015, and April 27, 2018, 726 patients were enrolled and randomly assigned, 362 to the ceftolozane-tazobactam group and 364 to the meropenem group. Overall, 519 (71%) patients had ventilator-associated pneumonia, 239 (33%) had Acute Physiology and Chronic Health Evaluation II scores of at least 20, and 668 (92%) were in the intensive care unit. At 28 days, 87 (24·0%) patients in the ceftolozane-tazobactam group and 92 (25·3%) in the meropenem group had died (weighted treatment difference 1·1% [95% CI -5·1 to 7·4]). At the test-of-cure visit 197 (54%) patients in the ceftolozane-tazobactam group and 194 (53%) in the meropenem group were clinically cured (weighted treatment difference 1·1% [95% CI -6·2 to 8·3]). Ceftolozane-tazobactam was thus non-inferior to meropenem in terms of both 28-day all-cause mortality and clinical cure at test of cure. Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group. Eight (2%) patients in the ceftolozane-tazobactam group and two (1%) in the meropenem group had serious treatment-related adverse events. There were no treatment-related deaths.
INTERPRETATION


High-dose ceftolozane-tazobactam is an efficacious and well tolerated treatment for Gram-negative nosocomial pneumonia in mechanically ventilated patients, a high-risk, critically ill population.
FUNDING


Merck & Co.",2019,Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group.,"['group and 364 to the meropenem group', 'Eligible patients were aged 18 years or older, were undergoing mechanical ventilation, and had nosocomial pneumonia (either ventilator-associated pneumonia or ventilated hospital-acquired pneumonia', '726 patients were enrolled and randomly assigned, 362 to the', 'Between Jan 16, 2015, and April 27, 2018', 'mechanically ventilated patients', '263 hospitals in 34 countries', 'Patients were randomly assigned (1:1) with block randomisation (block size four), stratified by type of nosocomial pneumonia and age (<65 years vs ≥65 years']","['combination antibacterial drug ceftolozane-tazobactam versus meropenem', 'Ceftolozane-tazobactam', 'ceftolozane-tazobactam or 1 g meropenem', 'Ceftolozane-tazobactam versus meropenem', 'ceftolozane-tazobactam', 'meropenem']","['Acute Physiology and Chronic Health Evaluation II scores', 'adverse events', 'Safety', 'efficacy and safety', '28-day all-cause mortality', 'clinical response at the test-of-cure visit', 'serious treatment-related adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3656593', 'cui_str': 'ceftolozane / tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",726.0,0.618555,Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group.,"[{'ForeName': 'Marin H', 'Initials': 'MH', 'LastName': 'Kollef', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nováček', 'Affiliation': 'General Hospital of Kolin, Kolin, Czech Republic.'}, {'ForeName': 'Ülo', 'Initials': 'Ü', 'LastName': 'Kivistik', 'Affiliation': 'North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Réa-Neto', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martin-Loeches', 'Affiliation': ""St James's Hospital, Dublin, Ireland; Universitat de Barcelona, Instituto de Investigaciones Biomédicas August Pi i Sunyer, Centro de Investigación Biomédica en Red Enfermedades Respiratorias, Barcelona, Spain.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'Université Paris Diderot, Paris, France.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bruno', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Huntington', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Rhee', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA. Electronic address: elizabeth.rhee@merck.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30403-7']
1606,32416201,Effect of exercise-based cardiac rehabilitation on clinical outcomes in patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA).,"BACKGROUND


Myocardial infarction in the absence of obstructive coronary artery disease (MINOCA) is characterized by clinical evidence of myocardial infarction with nonobstructive coronary stenosis on angiography (stenosis < 50%). Studies on the effect that exercise-based cardiac rehabilitation (CR) has on outcomes in MINOCA patients are lacking. Therefore, the purpose of this study was to determine the effect of exercise-based CR on clinical outcomes in patients with MINOCA.
METHODS


A total of 524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years. We randomly divided 524 patients into an exercise-based cardiac rehabilitation group (CR+) and a control group (CR-). The CR+ group followed a home-based exercise-training program three times a week during the three years of moderate continuous training (MCT; 65%-75% of peak heart rate) on a bicycle or treadmill.
RESULTS


After one year of follow-up, the Short Form 36 (SF-36) survey showed apparent improvement in the mean physical health score in the CR+ group compared with the CR- group (P < 0.01). During the three-year follow-up, all-cause mortality occurred in 60 individuals, and major adverse cardiovascular events (MACE) happened in 136 individuals. Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group. A multivariate Cox regression analysis indicated that exercise-based CR was associated with a significant reduction in all-cause mortality (hazard ratio [HR] = 0.483; 95% confidence interval [CI], 0.279-0.818; P < 0.01) and MACE (HR = 0.574; 95% CI, 0.403-0.827; P < 0.001).
CONCLUSIONS


A long-term exercise-based CR program was associated with superior physical health and a significant reduction in all-cause mortality and MACE in patients with MINOCA.",2020,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"['524 patients into an', 'patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA', '524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years', 'patients with MINOCA']","['exercise-based cardiac rehabilitation group (CR+) and a control group (CR', 'bicycle or treadmill', 'exercise-based cardiac rehabilitation (CR', 'exercise-based CR', 'exercise-based cardiac rehabilitation', 'CR']","['cause mortality', 'mean physical health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",524.0,0.0357636,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"[{'ForeName': 'Chao-Jie', 'Initials': 'CJ', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Yu-Yuan', 'Initials': 'YY', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Zhuo-Xuan', 'Initials': 'ZX', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Shi-Jun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Chang-Lin', 'Initials': 'CL', 'LastName': 'Zhai', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China. Electronic address: huhuilin1979@sohu.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.019']
1607,32415981,Association of hyponatraemia and renal function in type 1 cardiorenal syndrome.,"BACKGROUND


Hyponatraemia predicts type 1 cardiorenal syndrome in acute decompensated heart failure patients, which associates with poor outcome. Recovery from hyponatraemia has been found to associate with better outcome in acute decompensated heart failure patients, but its prognostic value regarding renal function remains unknown.
METHODS


We performed a secondary analysis of CARRESS-HF trial, and all patients included had worsening renal function (≥0.3 mg/dL increase in serum creatinine than the nadir). The serum sodium levels of patients were evaluated at baseline and day 4 and day 7 after randomization. Patients were grouped according to the status of hyponatraemia: recovery from hyponatraemia; no hyponatraemia; persistent hyponatraemia; and new-onset hyponatraemia. Their associations with persistent worsening renal function (serum creatinine ≥ 0.3 mg/dL higher than the nadir at discharge) were explored.
RESULTS


A total of 118 patients suffered from persistent worsening renal function. Baseline hyponatraemia was not associated with persistent worsening renal function (odds ratio = 0.495, P = .086). Patients in the recovery from hyponatraemia group had a lowest risk of persistent worsening renal function among the study population. Further, baseline serum sodium level was not associated with the risk of persistent worsening renal function (odds ratio = 1.055, P = .233), while the increases in serum sodium level at day 4 (odds ratio = 0.858, P = .003) and at day 7 (odds ratio = 0.821, P < .001) significantly predicted a lower risk of persistent worsening renal function.
CONCLUSIONS


Recovery from hyponatraemia associates with a lower risk of persistent worsening renal function, suggesting that hyponatraemia correction may improve renal outcomes in acute decompensated heart failure patients with type 1 cardiorenal syndrome.",2020,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","['acute decompensated heart failure patients', 'Patients were grouped according to the status of hyponatremia: recovery from hyponatremia, no hyponatremia, persistent hyponatremia, and new-onset hyponatremia', 'acute decompensated heart failure patients with type 1 cardiorenal syndrome', 'Type 1 Cardiorenal syndrome', '118 patients suffered from persistent worsening renal function']",[],"['renal outcomes', 'risk of persistent worsening renal function', 'worsening renal function', 'serum sodium level', 'Baseline hyponatremia', 'serum sodium levels', 'baseline serum sodium level']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",[],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",118.0,0.0620905,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","[{'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fangfei', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Owusu-Agyeman', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}]",European journal of clinical investigation,['10.1111/eci.13269']
1608,31403944,Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial.,"BACKGROUND


The current evidence is inconclusive to support the benefits of aerobic exercise training (AET) for preventing neurocognitive decline in patients with amnestic mild cognitive impairment (aMCI).
OBJECTIVE


To examine the effect of a progressive, moderate-to-high intensity AET program on memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition in aMCI patients.
METHODS


This is a proof-of-concept trial that randomized 70 aMCI patients to 12 months of AET or stretching and toning (SAT, active control) interventions. Primary neuropsychological outcomes were assessed by using the California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS). Secondary outcomes were the global and hippocampal brain volumes and the mean cortical and precuneus Aβ deposition.
RESULTS


Baseline cognitive scores were similar between the groups. Memory and executive function performance improved over time but did not differ between the AET and SAT groups. Brain volume decreased and precuneus Aβ plaque deposition increased over time but did not differ between the groups. Cardiorespiratory fitness was significantly improved in the AET compared with SAT group. In amyloid positive patients, AET was associated with reduced hippocampal atrophy when compared with the SAT group.
CONCLUSION


The AET and SAT groups both showed evidence of slightly improved neuropsychological scores in previously sedentary aMCI patients. However, these interventions did not prevent brain atrophy or increases in cortical Aβ deposition over 12 months. In amyloid positive patients, AET reduced hippocampal atrophy when compared with the SAT group.",2019,Brain volume decreased and precuneus,"['aMCI patients', 'Amnestic Mild Cognitive Impairment', 'patients with amnestic mild cognitive impairment (aMCI']","['Exercise Training', 'aerobic exercise training (AET', 'AET or stretching and toning (SAT, active control) interventions']","['global and hippocampal brain volumes and the mean cortical and precuneus', 'reduced hippocampal atrophy', 'California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS', 'memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition', 'hippocampal atrophy', 'Memory and executive function performance', 'plaque deposition', 'neuropsychological scores', 'Cardiorespiratory fitness', 'cortical Aβ deposition', 'Brain volume decreased and precuneus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C4505413', 'cui_str': 'Delis-Kaplan Executive Function System'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",70.0,0.124384,Brain volume decreased and precuneus,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Rossetti', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Tseng', 'Affiliation': 'Department of Health and Kinesiology, The University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'German', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Martin-Cook', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Stowe', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'Departments of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Diana R', 'Initials': 'DR', 'LastName': 'Kerwin', 'Affiliation': ""Institute for Texas Alzheimer's and Memory Disorders, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hynan', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Diaz-Arrastia', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181175']
1609,31563255,A Cost Analysis and Cost-Utility Analysis of a Community Pharmacist-Led Intervention on Reducing Cardiovascular Risk: The Alberta Vascular Risk Reduction Community Pharmacy Project (R x EACH).,"BACKGROUND


A randomized trial (the Alberta Vascular Risk Reduction Community Pharmacy Project) showed that a community pharmacist-led intervention was efficacious for reducing cardiovascular (CV) risk. However, the cost of this strategy is unknown.
OBJECTIVES


We examined the short- and long-term cost of a pharmacist-led intervention to reduce CV risk compared to usual care.
METHODS


We conducted a trial-based cost analysis from the perspective of a publicly funded healthcare system. Over 3 and 12 months of follow-up, we examined specific intervention costs (pharmacy claims), related intervention costs (laboratory tests and medications), and ongoing healthcare costs (physician claims, emergency department visits, and hospital admissions). We also used the validated CV Disease Policy Model-Canada to estimate the long-term effects.
RESULTS


A total of 684 participants (mean age 62, 57% male) were included. Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127). The CV disease-related healthcare cost of managing a patient over a lifetime was estimated to be Can$45 530 (95% uncertainty interval [UI], 45 460-45 580) and Can$40 750 (95% UI, 37 780-43 620) in usual care and intervention groups, respectively, an incremental cost savings of Can$4770 per patient (95% UI, 1900-7760). The intervention dominated usual care (better outcomes and lower costs) across 3-year, 5-year, 10-year, and lifetime horizons.
CONCLUSION


This economic analysis suggests that a clinical pathway-driven pharmacist-led intervention (previously shown to reduce CV risk) was associated with similar measured healthcare costs over 1 year, and lower extrapolated healthcare costs over a patient lifetime. This strategy could be broadly implemented to realize its benefits.",2019,"Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127).","['684 participants (mean age 62, 57% male) were included']","['pharmacist-led intervention', 'Community Pharmacist-Led Intervention']","['healthcare costs', 'CV risk', 'cardiovascular (CV) risk', 'CV disease-related healthcare cost of managing a patient over a lifetime', 'Cardiovascular Risk', 'specific intervention costs (pharmacy claims), related intervention costs (laboratory tests and medications), and ongoing healthcare costs (physician claims, emergency department visits, and hospital admissions']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",684.0,0.0863447,"Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tam-Tham', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Clement', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Brenda R', 'Initials': 'BR', 'LastName': 'Hemmelgarn', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address: brenda.hemmelgarn@ahs.ca.'}, {'ForeName': 'Braden J', 'Initials': 'BJ', 'LastName': 'Manns', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Klarenbach', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tonelli', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Department of Pharmacology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Yazid N', 'Initials': 'YN', 'LastName': 'Al Hamarneh', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Penko', 'Affiliation': 'Centre for Vulnerable Populations, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Colin G W', 'Initials': 'CGW', 'LastName': 'Weaver', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Au', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Weaver', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Southern Medical Program, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'McBrien', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Family Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.05.012']
1610,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS


There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants.
METHODS


By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood.
RESULTS


Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood.
CONCLUSIONS


The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916']
1611,27253669,Weight Loss and Lowering Androgens Predict Improvements in Health-Related Quality of Life in Women With PCOS.,"CONTEXT


Polycystic ovary syndrome (PCOS) is associated with reduced health-related quality of life (HRQOL) and increased prevalence of depressive and anxiety disorders. The impact of PCOS-specific treatments on these co-morbidities is unclear.
OBJECTIVE


To assess the impact of weight loss and decreasing hyperandrogenism on HRQOL and mood and anxiety disorders in women with PCOS.
DESIGN/SETTING/PARTICIPANTS


A secondary analysis of a randomized controlled trial (OWL-PCOS) of preconception treatment conducted at two academic centers in women (age, 18-40 years; body mass index, 27-42 kg/m(2)) with PCOS defined by Rotterdam criteria.
INTERVENTION


Continuous oral contraceptive pill (OCP) or intensive lifestyle intervention or the combination (Combined) for 16 weeks.
MAIN OUTCOME MEASURE(S)


Changes in HRQOL assessed by PCOSQ and SF-36 and prevalence of depression and anxiety disorder assessed by PRIME-MD PHQ.
RESULTS


The lowest scores were noted on the general health domain of the SF-36 and the weight and infertility domains on the PCOSQ. All three interventions resulted in significant improvement in the general health score on the SF-36. Both the OCP and Combined groups showed improvements in all domains of the PCOSQ (P < .01) compared to baseline scores. The Combined group had significant improvements in the weight, body hair, and infertility domains compared to a single treatment group (P < .05). In a linear regression model, change in weight correlated with improvements in the weight domain (P < .001) and physical well-being (P < .02), change in T correlated with improvements in the hair domain (P < .001), and change in both weight and T correlated with the infertility (P < .001) and menstrual domains (P < .05).
CONCLUSIONS


Both weight loss and OCP use result in significant improvements in several physical and mental domains related to quality of life, depressive symptoms, and anxiety disorders, and combined therapies offer further benefits in overweight/obese women with PCOS.",2016,"Both weight loss and OCP use result in significant improvements in several physical and mental domains related to quality of life, depressive symptoms, and anxiety disorders, and combined therapies offer further benefits in overweight/obese women with PCOS.","['overweight/obese women with PCOS', 'Women With PCOS', 'conducted at two academic centers in women (age, 18-40 years; body mass index, 27-42 kg/m(2)) with PCOS defined by Rotterdam criteria', 'Polycystic ovary syndrome (PCOS', 'women with PCOS']","['preconception treatment', 'Continuous oral contraceptive pill (OCP) or intensive lifestyle intervention or the combination (Combined) for 16 weeks', 'OCP']","['weight domain', 'PCOSQ', 'weight loss', 'general health score', 'general health domain of the SF-36 and the weight and infertility domains on the PCOSQ', 'weight, body hair, and infertility domains', 'quality of life, depressive symptoms, and anxiety disorders', 'Weight Loss', 'HRQOL assessed by PCOSQ and SF-36 and prevalence of depression and anxiety disorder assessed by PRIME-MD PHQ', 'reduced health-related quality of life (HRQOL', 'HRQOL and mood and anxiety disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4505063', 'cui_str': 'PRIME-MD'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.163086,"Both weight loss and OCP use result in significant improvements in several physical and mental domains related to quality of life, depressive symptoms, and anxiety disorders, and combined therapies offer further benefits in overweight/obese women with PCOS.","[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Milman', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Kunselman', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Christy M', 'Initials': 'CM', 'LastName': 'Stetter', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Gnatuk', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Estes', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Departments of Obstetrics and Gynecology (A.D., L.M., C.C.) and Psychiatry (D.B.S., K.C.A.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104; Departments of Obstetrics and Gynecology (C.L.G., S.J.E., R.S.L.), and Public Health Sciences (A.R.K., C.M.S., R.S.L.), Penn State College of Medicine, Hershey, Pennsylvania 17033; and Departments of Nutritional Sciences (P.M.K.-E., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2016-1896']
1612,29447076,"A double-blind, placebo-controlled, randomised clinical study of the effect of pork collagen peptide supplementation on atherosclerosis in healthy older individuals.",We examined whether baPWV could be affected by pork collagen peptide (CP) ingestion. Seventy subjects were randomized into two groups (2.5 g/day CP and 2.5 g/day placebo). A significant reduction in baPWV was observed in the CP group compared to the placebo group. This study demonstrated that pork CP may contribute to the prevention of atherosclerosis in elderly.,2018,A significant reduction in baPWV was observed in the CP group compared to the placebo group.,"['healthy older individuals', 'Seventy subjects']","['CP and 2.5\xa0g/day placebo', 'placebo', 'pork collagen peptide supplementation']",['baPWV'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]",[],70.0,0.216538,A significant reduction in baPWV was observed in the CP group compared to the placebo group.,"[{'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Kohara', 'Affiliation': 'The Faculty of Collaborative Regional Innovation, Ehime University, Matsuyama, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Igase', 'Affiliation': 'Department of Advanced Neurosurgery, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Peptide Division, Nitta Gelatin Incorporated, Osaka, Japan.'}, {'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Kutsuna', 'Affiliation': 'Department of Bone and Joint Surgery, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Miura', 'Affiliation': 'Department of Bone and Joint Surgery, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Ohyagi', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Toon, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2018.1434406']
1613,26620120,Bounding the per-protocol effect in randomized trials: an application to colorectal cancer screening.,"BACKGROUND


The per-protocol effect is the effect that would have been observed in a randomized trial had everybody followed the protocol. Though obtaining a valid point estimate for the per-protocol effect requires assumptions that are unverifiable and often implausible, lower and upper bounds for the per-protocol effect may be estimated under more plausible assumptions. Strategies for obtaining bounds, known as ""partial identification"" methods, are especially promising in randomized trials.
RESULTS


We estimated bounds for the per-protocol effect of colorectal cancer screening in the Norwegian Colorectal Cancer Prevention trial, a randomized trial of one-time sigmoidoscopy screening in 98,792 men and women aged 50-64 years. The screening was not available to the control arm, while approximately two thirds of individuals in the treatment arm attended the screening. Study outcomes included colorectal cancer incidence and mortality over 10 years of follow-up. Without any assumptions, the data alone provide little information about the size of the effect. Under the assumption that randomization had no effect on the outcome except through screening, a point estimate for the risk under no screening and bounds for the risk under screening are achievable. Thus, the 10-year risk difference for colorectal cancer was estimated to be at least -0.6 % but less than 37.0 %. Bounds for the risk difference for colorectal cancer mortality (-0.2 to 37.4 %) and all-cause mortality (-5.1 to 32.6 %) had similar widths. These bounds appear helpful in quantifying the maximum possible effectiveness, but cannot rule out harm. By making further assumptions about the effect in the subpopulation who would not attend screening regardless of their randomization arm, narrower bounds can be achieved.
CONCLUSIONS


Bounding the per-protocol effect under several sets of assumptions illuminates our reliance on unverifiable assumptions, highlights the range of effect sizes we are most confident in, and can sometimes demonstrate whether to expect certain subpopulations to receive more benefit or harm than others.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT00119912 (registered 6 July 2005).",2015,Bounds for the risk difference for colorectal cancer mortality (-0.2 to 37.4 %) and all-cause mortality (-5.1 to 32.6 %) had similar widths.,"['98,792 men and women aged 50-64 years']","['colorectal cancer screening', 'time sigmoidoscopy screening']","['10-year risk difference for colorectal cancer', 'colorectal cancer mortality', 'cause mortality', 'colorectal cancer incidence and mortality']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0037075', 'cui_str': 'Proctosigmoidoscopy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.216275,Bounds for the risk difference for colorectal cancer mortality (-0.2 to 37.4 %) and all-cause mortality (-5.1 to 32.6 %) had similar widths.,"[{'ForeName': 'Sonja A', 'Initials': 'SA', 'LastName': 'Swanson', 'Affiliation': 'Department of Epidemiology, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands. sswanson@hsph.harvard.edu.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Holme', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway. oyvind.holme@medisin.uio.no.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway. magnus.loberg@medisin.uio.no.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. mkalager@hsph.harvard.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. michael.bretthauer@medisin.uio.no.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hoff', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway. Geir.Hoff@kreftregisteret.no.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway. eline.aas@medisin.uio.no.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. miguel_hernan@post.harvard.edu.'}]",Trials,['10.1186/s13063-015-1056-8']
1614,31874985,Neural and behavioral changes driven by observationally-induced hypoalgesia.,"Observing successful pain treatment in others can induce anticipatory neural processes that, in turn, relieve pain. Previous studies have suggested that social learning and observation influence placebo hypoalgesia. Here, we used electroencephalography (EEG) to determine the neurophysiological changes associated with pain relief acquired through the observation. Thirty-one participants observed a demonstrator undergo painful heat stimulations paired with a ""control"" cream and non-painful ones paired with a ""treatment"" cream, which actually were both Vanicreams. After their observation, the participants then received the same creams and stimulations. We found that the treatment cream led to lower self-reported pain intensity ratings than the control cream. Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition. The P2 component localization indicated a higher current density in the right middle frontal gyrus, a region associated with attentional engagement. In placebo responders, the sensorimotor cortex activity captured in electrodes C3, Cz, and C4 indicated that hypoalgesia was positively correlated with resting state peak alpha frequency (PAF). These results suggest that observationally-induced placebo hypoalgesia may be driven by anticipatory mechanisms that modulate frontal attentional processes. Furthermore, resting state PAF could serve as a predictor of observationally-induced hypoalgesia.",2019,"Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition.",[],"['control"" cream and non-painful ones paired with a ""treatment"" cream']","['resting state peak alpha frequency (PAF', 'pain intensity ratings', 'sensorimotor cortex activity', 'electrodes F1, Fz, FC1, and FCz']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",31.0,0.0375226,"Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition.","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Social Neuroscience Lab, Max Planck Society, Berlin, Germany.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Furman', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tricou', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA. colloca@umaryland.edu.'}]",Scientific reports,['10.1038/s41598-019-56188-2']
1615,31556234,A prospective comparison between skin cooling and skin vibration in reducing the pain of local anesthetic infiltration.,"BACKGROUND


Growing evidence supports skin cooling (cryoanalgesia) or skin vibration (vibroanalgesia) as potential techniques for pain alleviation.
AIMS


To compare the effect of skin vibration using the Buzzy ®  vibration device with that of skin cooling for 2 minutes, as methods to reduce the pain of 1% lidocaine-epinephrine infiltration.
METHODS & MATERIALS


Sixty healthy volunteers were recruited for this prospective study. Each subject received an intradermal injection of the anesthetic solution after application of the Buzzy ®  vibration device in one arm and another injection after ice application in the other arm. After each injection, the subjects rated pain of infiltration on a 100-mm visual analog scale. Pain scores were compared using a paired t test.
RESULTS


Twenty-seven of sixty subjects (45%) reported that the 1% lidocaine-epinephrine infiltration after skin cooling was more painful than after skin vibration. Eleven subjects (18.3%) gave the same pain score for both techniques. The mean pain score ± SD was 30 ± 23.14 after skin cooling and 25.5 ± 24.1 after skin vibration. The difference between mean values was not statistically significant.
CONCLUSION


Skin vibration may be more effective than skin cooling in alleviating the pain caused by local anesthetic infiltration, although the difference was not statistically significant.",2020,The mean pain score ± SD was 30 ± 23.14 after skin cooling and 25.5 ± 24.1 after skin vibration.,['Sixty healthy volunteers'],"['lidocaine-epinephrine', 'skin cooling (cryoanalgesia) or skin vibration (vibroanalgesia', 'skin cooling and skin vibration']","['pain score', 'mean pain score\xa0±\xa0SD', 'subjects rated pain of infiltration on a 100-mm visual analog scale', 'Pain scores', 'pain of local anesthetic infiltration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}]",60.0,0.0288481,The mean pain score ± SD was 30 ± 23.14 after skin cooling and 25.5 ± 24.1 after skin vibration.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshahwan', 'Affiliation': 'King Saud University, Riyadh, Saudi Arabia.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13160']
1616,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
1617,31873098,Characterizing the temporal Dynamics of Melatonin and Cortisol Changes in Response to Nocturnal Light Exposure.,"We studied the dynamics of melatonin suppression and changes in cortisol levels in humans in response to light exposure at night using high-frequency blood sampling. Twenty-one young healthy participants were randomized to receive either intermittent bright (~9,500 lux) light (IBL), continuous bright light (CBL) or continuous dim (~1 lux) light (VDL) for 6.5 h during the biological night (n = 7 per condition). Melatonin suppression occurred rapidly within the first 5 min and continued until the end of each IBL stimuli (t 1/2  = ~13 min). Melatonin recovery occurred more slowly between IBL stimuli (half-maximal recovery rate of ~46 min). Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli. Suppression dynamics under CBL were also rapid (t 1/2  = ~18 min), with no recovery until the light exposure ended. There was a significant linear increase of cortisol levels between the start and end of each IBL stimulus. Under CBL conditions cortisol showed trimodal changes with an initial linear activating phase, followed by an exponential inhibitory phase, and a final exponential recovery phase. These results show that light exposure at night affects circadian driven hormones differently and that outcomes are influenced by the duration and pattern of light exposure.",2019,Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli.,"['Twenty-one young healthy participants', 'humans in response to light exposure at night using high-frequency blood sampling']","['intermittent bright (~9,500\u2009lux) light (IBL), continuous bright light (CBL) or continuous dim (~1\u2009lux) light (VDL']","['Melatonin suppression', 'Melatonin recovery', 'cortisol levels', 'Mean melatonin suppression']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",21.0,0.0173523,Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli.,"[{'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA. sarahman@rics.bwh.harvard.edu.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Gronfier', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}]",Scientific reports,['10.1038/s41598-019-54806-7']
1618,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND


Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION


The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS


Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS


All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE


Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
1619,32416781,"Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous immunosuppressive therapy within the 30 days before study drug administration. Eligible patients were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or double-matching placebo group. The primary endpoint was the recurrence-free survival in the intention-to-treat population. The results presented in this report reflect the prespecified interim analysis of recurrence-free survival after 90 events had been reported. This study is registered with ClinicalTrials.gov, NCT02523313, and is ongoing.
FINDINGS


Between Sept 2, 2015, and Nov 20, 2018, 167 patients were randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52). As of July 2, 2019, at a median follow-up of 28·4 months (IQR 17·7-36·8), median recurrence-free survival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free survival was 12·4 months (95% CI 5·3-33·3) in the nivolumab group and 6·4 months (3·3-9·6) in the placebo group. The hazard ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0·23 (97·5% CI 0·12-0·45; p<0·0001), and for the nivolumab group versus placebo group was 0·56 (0·33-0·94; p=0·011). In the nivolumab plus ipilimumab group, recurrence-free survival at 1 year was 75% (95% CI 61·0-84·9) and at 2 years was 70% (55·1-81·0); in the nivolumab group, 1-year recurrence-free survival was 52% (38·1-63·9) and at 2 years was 42% (28·6-54·5); and in the placebo group, this rate was 32% (19·8-45·3) at 1 year and 14% (5·9-25·7) at 2 years. Treatment-related grade 3-4 adverse events were reported in 71% (95% CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivolumab group. Treatment-related adverse events of any grade led to treatment discontinuation in 34 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab group. Three deaths from adverse events were reported but were considered unrelated to the study treatment.
INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease. The rates of grade 3-4 treatment-related adverse events in both active treatment groups were higher than the rates reported in previous pivotal trials done in advanced melanoma with measurable disease.
FUNDING


Bristol-Myers Squibb.",2020,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","['patients with resected stage IV melanoma with no evidence of disease (IMMUNED', '20 German academic medical centres', 'Between Sept 2, 2015, and Nov 20, 2018, 167 patients', 'patients with stage IV melanoma with no evidence of disease', 'Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy', 'patients with advanced-ie, unresectable or metastatic-melanoma', 'Eligible patients']","['nivolumab alone or in combination with ipilimumab', 'adjuvant nivolumab plus ipilimumab', 'nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo', 'nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab', 'nivolumab', 'nivolumab plus ipilimumab', 'Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo', 'placebo']","['Treatment-related grade 3-4 adverse events', 'rates of grade 3-4 treatment-related adverse events', 'hazard ratio for recurrence', 'safety and efficacy', 'recurrence-free survival', '1-year recurrence-free survival', 'median recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",167.0,0.766829,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Livingstone', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fluck', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Friedegund', 'Initials': 'F', 'LastName': 'Meier', 'Affiliation': 'Department of Dermatology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermatology, Elbe-Kliniken, Buxtehude, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schilling', 'Affiliation': 'Department of Dermatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Menzer', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kieker', 'Affiliation': 'Department of Dermatology, Charité Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Dippel', 'Affiliation': 'Department of Dermatology, Ludwigshafen Medical Center, Ludwigshafen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rösch', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'Department of Dermatology, Leipzig University Hospital Medical Center, Leipzig, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Körner', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Schwarz', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen C', 'Initials': 'JC', 'LastName': 'Becker', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Translational Skin Cancer Research, German Cancer Consortium (DKTK), Partner Site Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30417-7']
1620,32416385,Transdiagnostic preventative intervention for subclinical anxiety: Development and initial validation.,"Risk factors associated with the development of anxiety disorders have been identified; however, the development of preventive interventions targeting these risk factors is in the nascent stage. To date, preventive interventions have tended to target specific anxiety disorder symptoms (e.g., panic attacks). Although these interventions are effective at reducing risk for the targeted disorder (e.g., panic disorder), the focus of the intervention is narrow, thereby limiting the dissemination of these interventions. One approach that may broaden the scope of our prevention efforts is the development of a transdiagnostic intervention. Currently, transdiagnostic interventions have only been used in those with diagnosed conditions (e.g., anxiety disorders); however, it stands to reason that a transdiagnostic approach may also be helpful for those at-risk for developing anxiety disorders. The present study reported on the development and use of a brief preventative intervention for those with subclinical anxiety (i.e., worry, social anxiety). Participants were randomized into either a transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group. Participants consisted of sixty-nine individuals with subclinical levels of anxiety. Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group. Further, change in safety aid utilization was a significant mediator in the association between intervention group and social anxiety and worry at Week 1; however, it was not a significant mediator at Month 1. Implications of these results and avenues for future research are discussed.",2020,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.",['Participants consisted of sixty-nine individuals with subclinical levels of anxiety'],"['transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group', 'Transdiagnostic preventative intervention']","['safety aid utilization', 'social anxiety, worry, and levels of impairment', 'social anxiety and worry']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",69.0,0.0158088,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.","[{'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA; Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kkorte@mgh.harvard.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.001']
1621,32419536,"Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis:  post-hoc  analysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials.","Background:  The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis. Objectives:  To investigate the efficacy and safety of guselkumab in Korean patients. Methods:  The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively. Results:  Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%,  p <.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%,  p <.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%,  p <.001; IGA 0: 52.4 vs. 21.2%,  p =.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles. Conclusion:  The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.",2020,"At Week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7% vs 66.7%, p < 0.001; IGA 0: 52.4% vs 21.2%, p = 0.004).","['Korean patients with moderate-to-severe psoriasis', 'Korean psoriasis patients through 28 weeks', '126 randomized Korean patients, 30, 63, and 33 received', 'patients with moderate-to-severe psoriasis', 'Korean patients']","['placebo, guselkumab, and adalimumab', 'guselkumab', 'guselkumab and adalimumab', 'placebo and adalimumab', 'placebo']","[""Investigator's Global Assessment (IGA) score"", 'Psoriasis Area and Severity Index (PASI) 90 response', 'PASI 75 and IGA 0 (clear skin) responses', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.182754,"At Week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7% vs 66.7%, p < 0.001; IGA 0: 52.4% vs 21.2%, p = 0.004).","[{'ForeName': 'Sang Woong', 'Initials': 'SW', 'LastName': 'Youn', 'Affiliation': 'Department of Dermatology, Seoul National University Bundang Hospital and Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Medical Affairs, Janssen Korea Ltd., Seoul, Korea.'}, {'ForeName': 'Tae Yoon', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""Department of Dermatology, Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Byung Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Seung Chul', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Jeung Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Yong-Beom', 'Initials': 'YB', 'LastName': 'Choe', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo-Heung', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Jee-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Joo Young', 'Initials': 'JY', 'LastName': 'Roh', 'Affiliation': 'Department of Dermatology, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Seong Jin', 'Initials': 'SJ', 'LastName': 'Jo', 'Affiliation': 'Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun-So', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Ajou University Hospital, Suwon, Korea.'}, {'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Shin', 'Affiliation': 'Department of Dermatology, Kyunghee University Medical Center, Seoul, Korea.'}, {'ForeName': 'Min-Geol', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jingzhi', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Janssen Research & Development LLC, Spring House, PA, USA.'}, {'ForeName': 'YoungJa', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Medical Affairs, Janssen Korea Ltd., Seoul, Korea.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770174']
1622,32416432,Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.,"OBJECTIVE


Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer.
MATERIAL AND METHODS


We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO 2  peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression.
RESULTS


There was no significant difference between the intervention and control groups in VO 2  peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression.
CONCLUSION


There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO 2  peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.",2020,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"['patients with various types of cancer', 'patients with advanced inoperable lung cancer', '218 patients with advanced inoperable lung cancer', 'patients with advanced inoperable lung cancer undergoing']","['chemotherapy', 'exercise intervention', 'structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care']","['muscle strength outcomes', 'social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression', 'VO 2  peak', 'level of anxiety and depression', 'maximal oxygen uptake (VO 2  peak', 'muscle strength', 'muscle strength, functional capacity, forced expiratory volume in 1\u2009s, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",218.0,0.0758603,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark. Electronic address: morten.quist@regionh.dk.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Lærke', 'Initials': 'L', 'LastName': 'Winther', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Jørgen H', 'Initials': 'JH', 'LastName': 'Laursen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark; Department of Public Health, University of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.003']
1623,31556975,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY).","OBJECTIVE


Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD).
METHODS


This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score.
RESULTS


Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache.
CONCLUSIONS


Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03018340.",2019,Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week.,"['Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY', 'patients with major depressive disorder (MDD', 'patients with DSM-5-defined MDD and an inadequate response to a', 'patients with MDD', 'Between December 2016 and October 2018, 207 patients were randomized']","['Placebo', 'placebo or pimavanserin added to ongoing SSRI or SNRI therapy', 'pimavanserin', 'placebo or pimavanserin', 'pimavanserin from placebo', 'Pimavanserin', 'placebo', 'Adjunctive Pimavanserin', 'selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI']","['Tolerability', 'SDS score', 'efficacy and safety', 'dry mouth, nausea, and headache', 'HDRS-17 total score', '17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1579361', 'cui_str': 'SNRIs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}]",207.0,0.52314,Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, 55 Fruit St, Bulfinch 351, Boston, MA 02114. mfava@mgh.harvard.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12928']
1624,26593273,Different forms of prefrontal theta burst stimulation for executive function of medication- resistant depression: Evidence from a randomized sham-controlled study.,"BACKGROUND


Even during symptomatic remission, many patients with medication resistant depression (MRD) still demonstrate impaired cognitive function, especially executive function (EF). Theta-burst transcranial magnetic stimulation (TBS) modulates cortical excitability and may treat MRD. Evidences from previous studies show that intermittent TBS (iTBS) produces cortical excitatory effects, while continuous TBS (cTBS) produces a reduction of cortical excitability. EF is highly dependent on prefrontal activity, but the effects of different forms of prefrontal TBS on EF remain unknown.
METHODS


60 MRD patients were recruited and randomly assigned to one of four groups. Treatment was determined by the group to which an individual was assigned; A: cTBS 1800pulses/session; B: iTBS 1800pulses/session; C: a combination of cTBS+iTBS, 1800pulses/session for each; and D: sham TBS. Wisconsin Card Sorting Test (WCST) for the performance of EF was evaluated before and after 10 daily treatment sessions
RESULTS


Repeated measures ANOVA, with each WCST index at baseline and 2weeks after TBS as within-subject factors, demonstrated that a statistically significant interaction of TBS groups (G) and antidepressant responses [(R), responses were defined as >50% reduction of depression scores after 2-weeks TBS treatment] on the before-versus-after changes of all WCST indexes (G×R, p<0.05). Responders in Group B, but not in the other groups, showed a significant improvement in WCST performance. Only nonresponders in Group A showed a trend for EF worsening.
CONCLUSIONS


Our findings showed that left prefrontal iTBS, not right prefrontal cTBS, improved EF, and this can be independent from its antidepressant effects.",2016,"Responders in Group B, but not in the other groups, showed a significant improvement in WCST performance.","['patients with medication resistant depression (MRD', '60 MRD patients']","['cTBS+iTBS, 1800pulses/session for each; and D: sham TBS', 'intermittent TBS (iTBS', 'prefrontal theta burst stimulation', 'Theta-burst transcranial magnetic stimulation (TBS', 'Wisconsin Card Sorting Test (WCST']","['cortical excitability', 'WCST performance', 'depression scores', 'EF worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.057395,"Responders in Group B, but not in the other groups, showed a significant improvement in WCST performance.","[{'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan.'}, {'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Fu', 'Initials': 'CF', 'LastName': 'Chang', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan.'}, {'ForeName': 'Hsin Jie', 'Initials': 'HJ', 'LastName': 'Lu', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ying-Chiao', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: ctil2@vghtpe.gov.tw.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2015.11.009']
1625,31279647,Angioplasty with versus without routine stent placement for Budd-Chiari syndrome: a randomised controlled trial.,"BACKGROUND


Angioplasty recanalisation is recommended as the first-line interventional procedure for Budd-Chiari syndrome, but subsequent restenosis is common. We aimed to test whether use of routine, non-selective stenting in angioplasty could improve patency and treatment efficacy with adequate safety in Budd-Chiari syndrome.
METHODS


We did a randomised controlled trial, for which patients aged 18-75 years with Budd-Chiari syndrome with membranous obstruction or short-length stenosis (≤4 cm), and a Child-Pugh score of less than 13 were considered eligible. Patients were excluded if they had obstruction not amenable to angioplasty, were recommended to be treated with transjugular intrahepatic portosystemic shunt or liver transplantation, or had contraindications for angioplasty. Eligible patients were randomly assigned (1:1) to an angioplasty-only group or an angioplasty plus routine stenting group, with use of a web-based allocation system (Pocock and Simon's minimisation method, stratified by obstruction features and Child-Pugh score). Recanalisation procedures were done within 24 h of randomisation. The statistician and investigators responsible for data collection data and endpoint assessment were masked to group allocation. The primary outcome was the proportion of patients free of restenosis, analysed in the intention-to-treat population. The study is registered on ClinicalTrials.gov (NCT02201485) and is completed.
FINDINGS


Between July 28, 2014, and Sept 29, 2017, 88 (59%) of 150 screened patients were enrolled and assigned either the angioplasty-only group (n=45) or the angioplasty plus routine stenting group (n=43). During a median follow-up period of 27 months (IQR 19-41), the angioplasty plus routine stenting group had significantly higher proportion of patients free of restenosis (42 [98%] of 43 patients) than did the angioplasty-only group (27 [60%] of 45 patients; p<0·0001). In the survival analysis, 3-year restenosis-free survival was 96·0% (95% CI 88·6-100·0) in the routine stenting group versus 60·4% (46·4-78·7) in the angioplasty-only group (log-rank p<0·0001). The hazard ratio for restenosis was 0·04 (95% CI 0·01-0·31) in favour of routine stenting, with an absolute risk reduction of 35·6% (95% CI 24·2-55·0). Two (5%) patients in the angioplasty plus routine stenting group and one (2%) patient in the angioplasty-only group died during follow-up. One (2%) patient from the angioplasty plus routine stenting group had puncture site haematoma, which was not related to stenting. No stent fracture or migration occurred. Anticoagulation-related adverse events occurred in five (11%) patients from angioplasty alone group and five (12%) patients from angioplasty plus routine stenting group.
INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment. Further validation is needed in similar settings and other regions in which different characteristics of Budd-Chiari syndrome are more prevalent.
FUNDING


National Natural Science Foundation of China, National Key Technology R&D Programme, Optimised Overall Project of Shaanxi Province, Boost Programme of Xijing Hospital.",2019,"INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment.","['Between July 28, 2014, and Sept 29, 2017, 88 (59%) of 150 screened patients', 'Patients were excluded if they had obstruction not amenable to angioplasty', 'Budd-Chiari syndrome', 'patients with Budd-Chiari syndrome with short-length stenosis', 'patients aged 18-75 years with Budd-Chiari syndrome with membranous obstruction or short-length stenosis (≤4 cm), and a Child-Pugh score of less than 13 were considered eligible', 'Eligible patients']","['Angioplasty with versus without routine stent placement', 'angioplasty alone', ""angioplasty-only group or an angioplasty plus routine stenting group, with use of a web-based allocation system (Pocock and Simon's minimisation method, stratified by obstruction features and Child"", 'angioplasty plus routine stenting', 'transjugular intrahepatic portosystemic shunt or liver transplantation, or had contraindications for angioplasty']","['hazard ratio for restenosis', 'proportion of patients free of restenosis, analysed in the intention-to-treat population', 'Anticoagulation-related adverse events', 'survival analysis, 3-year restenosis-free survival', 'proportion of patients free of restenosis', 'puncture site haematoma']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0856761', 'cui_str': ""Chiari's Syndrome""}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333172', 'cui_str': 'Membranous obstruction (morphologic abnormality)'}, {'cui': 'C2347612', 'cui_str': 'Child-Pugh score (assessment scale)'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",,0.159232,"INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment.","[{'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Chuangye', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xulong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xingshun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Enxing', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhexuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shaanxi, China; Information Technology Department, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ultrasound, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhanxin', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: hangh@fmmu.edu.cn.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30177-3']
1626,26457385,Smoking Cessation in Individuals With Serious Mental Illness: A Randomized Controlled Trial of Two Psychosocial Interventions.,"OBJECTIVE


Smoking among individuals with serious mental illness is a critical public health problem. Although guidelines recommend bupropion for these smokers, many do not want to use medications for smoking cessation, express ambivalence about identifying a ""quit date,"" and do not have access to behavioral smoking cessation services integrated with mental health care.
METHODS


Individuals with serious mental illness who smoked 10 or more cigarettes per day (N = 178) were randomized to either a multifaceted behavioral group intervention or a supportive group intervention, both of which were integrated within outpatient mental health services at three VA medical centers. Participants attended twice-weekly meetings for 12 weeks, provided information on their smoking at each meeting, and completed baseline and post-treatment assessments conducted by an assessor who was blind to condition. Primary outcomes collected at post-treatment included 1-week abstinence, number of cigarettes smoked per day during the last week, and number of quit attempts during the treatment period. Outcomes examined for a subset of participants who attended at least one intervention meeting (n = 152) included smoking abstinence for 1-, 2-, and 4-week blocks during the treatment period. Analyses conducted on those participants who attended three or more intervention meetings (n = 127) included time to 50% reduction in the number of cigarettes smoked and time to first quit attempt.
RESULTS


Sixteen participants achieved abstinence (11.8%), smoking quantity was significantly reduced (baseline M = 15.2, SD = 9.8 to post-treatment M = 7.5, SD = 7.7, p <.0001), and most reported making a quit attempt (n = 88, 72.7%). There were no differences by study condition on any abstinence or reduction outcomes. Significant reductions in number of cigarettes smoked generally took place within the first two weeks; however, these reductions did not often translate into abstinence.
CONCLUSIONS


Many participants reduced their smoking and sampled quitting during the study. Implementing smoking cessation services in mental health treatment settings is feasible and, if delivered in line with best practices, either a behavioral or a supportive approach can be helpful. Future research should examine ways to facilitate the transition from reduction to abstinence. This study was part of a clinical trial registered as NCT #00960375 at www.clinicaltrials.gov.",2015,There were no differences by study condition on any abstinence or reduction outcomes.,"['Individuals with serious mental illness who smoked 10 or more cigarettes per day', 'participants who attended three or more intervention meetings (n = 127', 'individuals with serious mental illness', 'N = 178', 'Individuals With Serious Mental Illness']","['bupropion', 'multifaceted behavioral group intervention or a supportive group intervention']","['abstinence', '1-week abstinence, number of cigarettes smoked per day during the last week, and number of quit attempts', 'number of cigarettes smoked generally took place', 'number of cigarettes smoked and time to first quit attempt', 'smoking abstinence', 'smoking quantity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",178.0,0.0925679,There were no differences by study condition on any abstinence or reduction outcomes.,"[{'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Bennett', 'Affiliation': 'a VA VISN 5 Mental Illness Research, Education, and Clinical Center , Baltimore , Maryland , USA.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'a VA VISN 5 Mental Illness Research, Education, and Clinical Center , Baltimore , Maryland , USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'b Department of Psychiatry , University of Maryland School of Medicine , Baltimore , Maryland , USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Himelhoch', 'Affiliation': 'a VA VISN 5 Mental Illness Research, Education, and Clinical Center , Baltimore , Maryland , USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bellack', 'Affiliation': 'b Department of Psychiatry , University of Maryland School of Medicine , Baltimore , Maryland , USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dixon', 'Affiliation': 'a VA VISN 5 Mental Illness Research, Education, and Clinical Center , Baltimore , Maryland , USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2015.1104481']
1627,31385880,Ultra-Protective Ventilation Reduces Biotrauma in Patients on Venovenous Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome.,"INTRODUCTION


Ventilator settings for patients with severe acute respiratory distress syndrome supported by venovenous extracorporeal membrane oxygenation are currently set arbitrarily. The impact on serum and pulmonary biotrauma markers of the transition to ultra-protective ventilation settings following extracorporeal membrane oxygenation implantation, and different mechanical ventilation strategies while on extracorporeal membrane oxygenation were investigated.
DESIGN


Randomized clinical trial.
SETTINGS


Nine-month monocentric study.
PATIENTS


Severe acute respiratory distress syndrome patients on venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


After starting extracorporeal membrane oxygenation, patients were switched to the bi-level positive airway pressure mode with 1 second of 24 cm H2O high pressure and 2 seconds of 12 cm H2O low pressure for 24 hours. A computer-generated allocation sequence randomized patients to receive each of the following three experimental steps: 1) high pressure 24 cm H2O and low pressure 20 cm H2O (very high positive end-expiratory pressure-very low driving pressure); 2) high pressure 24 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-high driving pressure); and 3) high pressure 17 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-low driving pressure). Plasma and bronchoalveolar lavage soluble receptor for advanced glycation end-products, plasma interleukin-6, and monocyte chemotactic protein-1 were sampled preextracorporeal membrane oxygenation and after 12 hours at each step.
MEASUREMENTS AND MAIN RESULTS


Sixteen patients on ECMO after 7 days (1-11 d) of mechanical ventilation were included. ""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations. Plasma sRAGE and cytokines were comparable within each on-ECMO experimental step, but the lowest bronchoalveolar lavage sRAGE levels were obtained at minimal driving pressure.
CONCLUSIONS


ECMO allows ultra- protective ventilation, which combines significantly lower plateau pressure, tidalvolume, and driving pressure. This ventilation strategy significantly limited pulmonary biotrauma, which couldtherefore decrease ventilator-induced lung injury. However, the optimal ultra-protective ventilation strategy once ECMO is initiated remains undetermined and warrants further investigations. (Crit Care Med 2019; 47:1505-1512).",2019,"""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations.","['Severe acute respiratory distress syndrome patients', 'Sixteen patients on ECMO after 7 days (1-11 d) of mechanical ventilation were included', 'Severe Acute Respiratory Distress Syndrome', 'patients with severe acute respiratory distress syndrome', 'Nine-month monocentric study']","['high pressure 24 cm H2O and low pressure 20 cm H2O (very high positive end-expiratory pressure-very low driving pressure); 2) high pressure 24 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-high driving pressure); and 3) high pressure 17 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-low driving pressure', 'extracorporeal membrane oxygenation implantation', 'Ultra-Protective Ventilation Reduces Biotrauma', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation']","['plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations', 'plateau pressure, tidalvolume, and driving pressure', 'bronchoalveolar lavage sRAGE levels', 'Plasma sRAGE and cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0391895', 'cui_str': 'Venovenous (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.111979,"""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations.","[{'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Rozencwajg', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Guihot', 'Affiliation': ""Département d'Immunologie, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, 75651 Paris Cedex 13, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Franchineau', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Lescroat', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bréchot', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Hékimian', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lebreton', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Autran', 'Affiliation': ""Département d'Immunologie, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, 75651 Paris Cedex 13, France.""}, {'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Combes', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}]",Critical care medicine,['10.1097/CCM.0000000000003894']
1628,32416779,Trial and error.,,2020,,[],[],[],[],[],[],,0.0803244,,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ofri', 'Affiliation': 'Bellevue Hospital, NYU School of Medicine, New York, NY 10016, USA. Electronic address: danielle.ofri@nyumc.org.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30965-X']
1629,30859503,"Capsule Commentary on Anthenelli et al., Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.",,2019,,[],[],[],[],[],[],,0.052487,,"[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Young-Wolff', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04909-8']
1630,32416780,"Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase 3 trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma.
METHODS


In this multicentre, phase 3, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/m 2  body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m 2  body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival (group A vs group C) and overall survival (group B vs group C), which was to be formally tested only if overall survival was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636.
FINDINGS


Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients. 451 (37%) were randomly assigned to group A, 362 (30%) to group B, and 400 (33%) to group C. Median follow-up for survival was 11·8 months (IQR 6·1-17·2) for all patients. At the time of final progression-free survival analysis and interim overall survival analysis (May 31, 2019), median progression-free survival in the intention-to-treat population was 8·2 months (95% CI 6·5-8·3) in group A and 6·3 months (6·2-7·0) in group C (stratified hazard ratio [HR] 0·82, 95% CI 0·70-0·96; one-sided p=0·007). Median overall survival was 16·0 months (13·9-18·9) in group A and 13·4 months (12·0-15·2) in group C (0·83, 0·69-1·00; one-sided p=0·027). Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24). Adverse events that led to withdrawal of any agent occurred in 156 (34%) patients in group A, 22 (6%) patients in group B, and 132 (34%) patients in group C. 50 (11%) patients in group A, 21 (6%) patients in group B, and 27 (7%) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo.
INTERPRETATION


Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinum-based chemotherapy as a potential first-line treatment option for metastatic urothelial carcinoma.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","['0·82', 'patients with metastatic urothelial carcinoma', 'Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients', 'metastatic urothelial cancer (IMvigor130', 'first-line metastatic urothelial carcinoma', 'untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries', 'metastatic urothelial carcinoma']","['atezolizumab to platinum-based chemotherapy', 'carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin', 'Atezolizumab', 'atezolizumab', 'atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy', 'IMvigor130', 'atezolizumab plus platinum-based chemotherapy', 'gemcitabine', 'placebo plus platinum-based chemotherapy', 'Atezolizumab with or without chemotherapy', 'atezolizumab monotherapy', 'placebo']","['Median overall survival', 'median progression-free survival', 'Adverse events', 'overall survival', 'time of final progression-free survival analysis and interim overall survival analysis', 'intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",1213.0,0.469836,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. Electronic address: matthew.galsky@mssm.edu.'}, {'ForeName': 'José Ángel Arranz', 'Initials': 'JÁA', 'LastName': 'Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Charité University Hospital, Berlin, Germany; Department of Urology, Medical University, Vienna, Austria.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia-Del-Muro', 'Affiliation': 'Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mencinger', 'Affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Panni', 'Affiliation': 'Istituti Ospitalieri Cremona, Cremona, Italy.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gumus', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jian-Ri', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Taichung Veterans General Hospital, HungKuang University, Taichung, Taiwan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bernhard', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tayama', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Mecke', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'AnnChristine', 'Initials': 'A', 'LastName': 'Thåström', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30230-0']
1631,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
1632,32418143,"Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Dual antiplatelet therapy, aspirin and a P2Y 12  inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.
METHODS


This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix ®  (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel were calculated.
RESULTS


In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD W ) was at least 0.294 for acetylsalicylic acid C max , AUC last , and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
CONCLUSION


Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.
TRIAL REGISTRATION


CTR20181695.",2020,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","['171 healthy subjects', 'Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study', 'healthy Chinese subjects under fasting conditions', 'Chinese Subjects Under Fasting Conditions', 'healthy Chinese volunteers', 'Chinese male and female healthy volunteers']","['Clopidogrel plus acetylsalicylic acid combination', 'acetylsalicylic acid and 75\xa0mg clopidogrel', 'acetylsalicylic acid', 'acetylsalicylic acid and clopidogrel', 'aspirin', 'Clopidogrel Versus Enteric Aspirin', 'Co-Plavix ®  (test formulation- fixed-dose combination of 100\xa0mg acetylsalicylic acid and 75\xa0mg clopidogrel', 'Clopidogrel\u2009+\u2009acetylsalicylic acid']","['Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel', 'geometric mean ratios of clopidogrel C max , AUC last , and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0504812,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China. jie.hou@estartpoc.com.'}]",Advances in therapy,['10.1007/s12325-020-01369-z']
1633,32418361,"Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal-Dominant Alzheimer's Disease Colombia Trial.","INTRODUCTION


The API AutosomalDominant AD (ADAD) Colombia Trial is a placebo-controlled clinical trial of crenezumab in 252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1) E280A kindred members, including mutation carriers randomized to active treatment or placebo and non-carriers who receive placebo.
METHODS


Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity.
RESULTS


We summarize demographic, clinical, cognitive, and behavioral data from 167 mutation carriers and 75 non-carriers, 30 to 53 years of age. Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
DISCUSSION


Although PSEN1 E280A mutation carriers in the Trial are cognitively unimpaired, they have slightly lower MMSE and memory scores than non-carriers. Their demographic characteristics are representative of the local population.",2020,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","['167 mutation carriers and 75 non-carriers, 30 to 53 years of age', '252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1', 'Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity', 'E280A kindred members, including mutation carriers randomized to active treatment or']","['API AutosomalDominant AD (ADAD', 'placebo and non-carriers who receive placebo', 'crenezumab', 'placebo']",['Mini Mental Status Exam (MMSE) scores'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0299212', 'cui_str': 'Presenilin 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.37236,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Rios-Romenets', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lopera', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cho', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Mackey', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Langbaum', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'University of California, San Diego, California, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giraldo-Chica', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tobon', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Acosta-Baena', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ospina', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Tirado', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Henao', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Bocanegra', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Dhruman', 'Initials': 'D', 'LastName': 'Goradia', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Thiyyagura', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'VanGilder', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ghisays', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Malek-Ahmadi', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Protas', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reiman', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12109']
1634,31552831,The Impact of Early Postpartum Maternal Pertussis Vaccination on the Protection of Infants: A Randomized Clinical Trial.,"BACKGROUND


Despite primary vaccination, infants under six months run a risk of infection with pertussis.
OBJECTIVE


To determine the impact of early postpartum maternal pertussis vaccination on protecting infants from the disease.
METHODS


All mothers (n=405) who gave birth to healthy term infants were educated on the cocoon strategy. The mothers who consented were immunized with the tetanus-diphtheria-acellular pertussis vaccine within the first three postpartum days. All infants received their pertussis vaccines according to the national schedule. The anti-pertussis IgG titers of infants of thirty vaccinated mothers were compared with those of thirty unvaccinated mothers.
RESULTS


The pertussis antibody levels in the infants of vaccinated mothers were significantly higher than those of unvaccinated mothers at the mean infant age of 5.6 ± 1.2 months. Only 6 infants of vaccinated mothers exhibited pertussis-like symptoms, none of whom had positive pertussis PCR. Seventeen infants of unvaccinated mothers had pertussis-like symptoms, and 4 tested positive for pertussis PCR.
CONCLUSION


Our results showed that maternal pertussis vaccination, administered within the first three postpartum days, may protect infants against pertussis in their first ten months.",2019,The pertussis antibody levels in the infants of vaccinated mothers were significantly higher than those of unvaccinated mothers at the mean infant age of 5.6 ± 1.2 months.,"['protecting infants from the disease', 'Infants', 'All mothers (n=405) who gave birth to healthy term infants were educated on the cocoon strategy', 'Seventeen infants of unvaccinated mothers']",['tetanus-diphtheria-acellular pertussis vaccine'],"['pertussis-like symptoms', 'pertussis antibody levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0599994', 'cui_str': 'Overprotected (finding)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}]","[{'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}]","[{'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0525281,The pertussis antibody levels in the infants of vaccinated mothers were significantly higher than those of unvaccinated mothers at the mean infant age of 5.6 ± 1.2 months.,"[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Kılıç', 'Affiliation': 'Department of Pediatrics, Istanbul Medical School, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Gülçin Otar', 'Initials': 'GO', 'LastName': 'Yener', 'Affiliation': ''}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Yetim', 'Affiliation': ''}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özçetin', 'Affiliation': ''}, {'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Gökçay', 'Affiliation': ''}, {'ForeName': 'Asuman', 'Initials': 'A', 'LastName': 'Çoban', 'Affiliation': ''}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ince', 'Affiliation': ''}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Yaşa', 'Affiliation': ''}, {'ForeName': 'Lütfiye', 'Initials': 'L', 'LastName': 'Öksüz', 'Affiliation': ''}, {'ForeName': 'Funda Güngör', 'Initials': 'FG', 'LastName': 'Uğurlucan', 'Affiliation': ''}, {'ForeName': 'Nezahat', 'Initials': 'N', 'LastName': 'Gürler', 'Affiliation': ''}]",Iranian journal of immunology : IJI,['10.22034/IJI.2019.80273']
1635,32419861,Combination Therapy and Opioids: Effectiveness of Transcranial Direct-Current Stimulation (tDCS) and Emotion Regulation Training in Reducing Current Drug Craving.,"Background and objectives:  Craving is the main symptom of addiction that is accompanied by dependence and relapse. The present study was aimed to compare the effectiveness of combined Transcranial Direct-Current Stimulation (tDCS) and emotion regulation training with that of separate tDCS and emotion regulation training in reducing current drug craving and thoughts and fantasies about drug use.  Materials and methodology:  This was a quasi-experimental study with a pretest-posttest design and three intervention groups. The statistical population included all patients dependent on opioids in medium-term residential drug rehabilitation centers in Zahedan, Iran, in 2018-2019. From eight randomly selected centers, a total of 54 patients were selected based on inclusion and exclusion criteria, and randomly divided into three intervention groups. Data were gathered using the Personal Drug Use Questionnaire, Desires for Drug Questionnaire (DDQ), and Drug Use Thoughts, Fantasies, and Temptations Questionnaire. All analyses were performed using SPSS-16.  Results:  The Kruskal-Wallis test indicated significant differences between the three intervention groups in current drug craving and thoughts and fantasies about drug use (P ..001). In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  Conclusion:  Addiction is very similar to other chronic disorders. Therefore, combined (integrated) therapies can have a very important role in treating addiction, especially in relapse prevention.",2020,"In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  ","['patients dependent on opioids in medium-term residential drug rehabilitation centers in Zahedan, Iran, in 2018-2019', 'From eight randomly selected centers, a total of 54 patients were selected based on inclusion and exclusion criteria']","['combined Transcranial Direct-Current Stimulation (tDCS) and emotion regulation training with that of separate tDCS and emotion regulation training', 'Transcranial Direct-Current Stimulation (tDCS) and Emotion Regulation Training', 'Combination Therapy and Opioids']","['current drug craving and thoughts and fantasies about drug use', 'Personal Drug Use Questionnaire, Desires for Drug Questionnaire (DDQ), and Drug Use Thoughts, Fantasies, and Temptations Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1510463', 'cui_str': 'Drug Rehabilitation Centers'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0015630', 'cui_str': 'Fantasy'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",54.0,0.0197076,"In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  ","[{'ForeName': 'Kooteh', 'Initials': 'K', 'LastName': 'Behzad Rigi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Behavioral Science, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}, {'ForeName': 'Dolatshahi', 'Initials': 'D', 'LastName': 'Behrooz', 'Affiliation': 'Substance Abuse and Dependence Research Center, Department of Clinical Psychology, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}, {'ForeName': 'Nosratabadi', 'Initials': 'N', 'LastName': 'Masoud', 'Affiliation': 'University of Social Welfare and Rehabilitation Science, Paarand Specialized Center for Human Enhancement, Tehran, Iran.'}, {'ForeName': 'Bakhshani', 'Initials': 'B', 'LastName': 'Nour Mohammad', 'Affiliation': ""Children and Adolescents' Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.""}, {'ForeName': 'Mahdavi', 'Initials': 'M', 'LastName': 'Abed', 'Affiliation': 'Department of Psychology and Educational Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Hakami', 'Initials': 'H', 'LastName': 'Mousa Chakeri', 'Affiliation': 'Department of Clinical Psychology, Faculty of Behavioral Science, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}]",Maedica,['10.26574/maedica.2020.15.1.53']
1636,32419949,Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study.,"Background


Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.
Methods


Single-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.
Results


Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all  P  >   0.05). There was no significant difference between groups in diagnostic yield ( P  =   0.69), mean gastric ( P  =   0.10) or small-bowel transit time ( P  =   0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%;  P  =   0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
Conclusions


Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).",2020,"Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
","['Fifty patients were prospectively enrolled (56% female) with a median age of 54.4\u2009years and 44 completed the study (23 patients in the control group and 21 in the preparation group', 'outpatients scheduled for CE', 'small-bowel capsule endoscopy']","['metoclopramide', 'polyethylene glycol solution', '\n\n\nCapsule endoscopy (CE']","['small-bowel transit time', 'small-bowel completion rate', 'small-bowel visualization', 'quartile-based small-bowel visualization', 'diagnostic yield', 'patient discomfort', 'CE performance', 'CE completion rate', 'discomfort', 'mean gastric']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]","[{'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]",50.0,0.0833449,"Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Hansel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Alexander', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Bruining', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Mangan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Dierkhising', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Almazar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}]",Gastroenterology report,['10.1093/gastro/goz054']
1637,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND


People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered.
METHODS


A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV.
RESULTS


920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%).
CONCLUSION


Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755']
1638,30922751,Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease.,"OBJECTIVE


Home-based exercise is an alternative exercise mode to a structured supervised program to improve symptoms in patients with peripheral artery disease (PAD), but little is known about whether the slow-paced and less intense home program also elicits changes in vascular and inflammatory biomarkers. In an exploratory analysis from a randomized controlled trial, we compared changes in vascular and inflammatory biomarkers in patients with symptomatic PAD (typical and atypical of claudication) after home-based exercise and supervised exercise programs and in an attention-control group.
METHODS


A total of 114 patients were randomized into one of the three groups (n = 38 per group). Two groups performed exercise interventions, consisting of home-based and supervised programs of intermittent walking to mild to moderate claudication pain for 12 weeks; a third group performed light resistance training as a nonwalking attention-control group. Before and after intervention, patients were characterized on treadmill performance and endothelial effects of circulating factors present in sera by a cell culture-based bioassay on primary human arterial endothelial cells, and they were further evaluated on circulating vascular and inflammatory biomarkers.
RESULTS


Treadmill peak walking time increased (P = .008) in the two exercise groups but not in the control group (P > .05). Cultured endothelial cell apoptosis decreased after home-based exercise (P < .001) and supervised exercise (P = .007), and the change in the exercise groups combined was different from that in the control group (P = .005). For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only. The changes in hydroxyl radical antioxidant capacity (P = .005), vascular endothelial growth factor A (P = .008), and E-selectin (P = .034) in the exercise groups combined were different from those in the control group.
CONCLUSIONS


This exploratory analysis found that both home-based and supervised exercise programs are efficacious to decrease cultured endothelial cell apoptosis in patients with symptomatic PAD. Furthermore, a monitored home-based exercise program elicits additional vascular benefits by improving circulating markers of endogenous antioxidant capacity, angiogenesis, endothelium-derived inflammation, and blood glucose concentration in patients with symptomatic PAD. The novel clinical significance is that important trends were found in this exploratory analysis that a contemporary home-based exercise program and a traditional supervised exercise program may favorably improve vascular and inflammatory biomarkers in addition to the well-described ambulatory improvements in symptomatic patients with PAD.",2019,"For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only.","['patients with symptomatic PAD', 'A total of 114 patients', 'patients with symptomatic peripheral artery disease', 'patients with peripheral artery disease (PAD', 'symptomatic patients with PAD', 'patients with symptomatic PAD (typical and atypical of claudication) after home-based']","['exercise interventions, consisting of home-based and supervised programs of intermittent walking to mild to moderate claudication pain for 12\xa0weeks; a third group performed light resistance training as a nonwalking attention-control group', 'exercise and supervised exercise programs and in an attention-control group']","['E-selectin', 'hydroxyl radical antioxidant capacity', 'supervised exercise', 'vascular endothelial growth factor A', 'Cultured endothelial cell apoptosis', 'blood glucose concentration', 'Treadmill peak walking time', 'circulating markers of endogenous antioxidant capacity, angiogenesis, endothelium-derived inflammation, and blood glucose concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",114.0,0.0401821,"For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only.","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Gardner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State College of Medicine, Hershey, Pa. Electronic address: agardner4@pennstatehealth.psu.edu.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Parker', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Okla.'}, {'ForeName': 'Polly S', 'Initials': 'PS', 'LastName': 'Montgomery', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State College of Medicine, Hershey, Pa.'}]",Journal of vascular surgery,['10.1016/j.jvs.2018.12.056']
1639,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht  Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht  Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413']
1640,31144282,Communicating a Prognosis: a Randomized Trial of Survival Rate Language.,,2019,,[],[],[],[],[],[],,0.121896,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Silver', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Broomell', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Davis', 'Affiliation': 'Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA. tamark@pitt.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05056-w']
1641,31545017,Sequential peeling as a monotherapy for treatment of milder forms of acne vulgaris.,"BACKGROUND


Glycolic acid (GA) and salicylic acid (SA) peels have been used separately for acne treatment, not as a sequential peel.
AIM


To evaluate the efficacy and safety of sequential peeling with 70% GA and 20% SA as a monotherapy and as an adjuvant to systemic doxycycline in treatment of mild to moderate acne and the effect on serum interleukin (IL) 17 and tissue IL-1α.
PATIENTS/METHODS


Forty-five mild to moderate acne vulgaris patients were randomly assigned into three groups. Group [A] underwent sequential application of 70% GA followed by 20% SA biweekly for three months. Group [B] underwent sequential peeling and doxycycline PO100 mg BD for 1 month followed by 100 OD for 2 months. Group [C] received oral doxycycline. Acne grading, lesion counting, and patient satisfaction were assessed. Serum samples and perilesional skin biopsies were obtained at onset and 2 weeks after finishing the treatment for assessment of serum IL-17 and tissue IL-1α.
RESULTS


All groups showed statistically significant decrease in acne grading and lesion count, increase in patient satisfaction, and decrease in serum IL-17 and tissue IL-1 α after treatment. There was no significant difference between the 3 groups before or after treatment, except regarding patient satisfaction after treatment, which was significantly higher in groups [A] and [B] than group [C] (P = .001).
CONCLUSIONS


This study recommends using sequential GA 70% and SA 20% peels in the treatment of mild or moderate acne vulgaris as a new cost-effective mode, with low-down time and potential safety, in noncompliant patients on medical therapy.",2020,"There was no significant difference between the 3 groups before or after treatment, except regarding patient satisfaction after treatment, which was significantly higher in groups [A] and [B] than group [C] (P = .001).
",['Forty-five mild to moderate acne vulgaris patients'],"['sequential peeling and doxycycline PO100', 'doxycycline', 'oral doxycycline', 'Glycolic acid (GA) and salicylic acid (SA) peels', 'sequential peeling with 70% GA and 20% SA']","['serum IL-17 and tissue IL-1 α', 'efficacy and safety', 'Acne grading, lesion counting, and patient satisfaction', 'acne grading and lesion count', 'Serum samples and perilesional skin biopsies', 'patient satisfaction']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1533643', 'cui_str': 'glycolic acid'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}]",100.0,0.0344187,"There was no significant difference between the 3 groups before or after treatment, except regarding patient satisfaction after treatment, which was significantly higher in groups [A] and [B] than group [C] (P = .001).
","[{'ForeName': 'Amira Amin', 'Initials': 'AA', 'LastName': 'Zayed', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Sobhi', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Randa Mohamed Saleh', 'Initials': 'RMS', 'LastName': 'El Aguizy', 'Affiliation': 'Dermatology Department, El Haud El Marsoud Hospital, Cairo, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Sabry', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sara Bahaa', 'Initials': 'SB', 'LastName': 'Mahmoud', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13162']
1642,27042931,Rationale and design of the European Polyp Surveillance (EPoS) trials.,"BACKGROUND


Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational study investigating evidence-based surveillance strategies following polyp removal. Study design and endpoints: The EPoS studies started to recruit patients in April 2015. EPoS study I randomizes 13 746 patients with low-risk adenomas (1 - 2 tubular adenomas size < 10 mm, low-grade dysplasia) to surveillance after 5 and 10 years, or 10 years only. EPoS study II randomizes 13 704 patients with high-risk adenomas (3 - 10 adenomas or adenoma ≥ 10 mm in diameter, or adenoma with high-grade dysplasia, or > 25 % villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only. EPoS study III offers surveillance after 5 and 10 years to patients with serrated polyps ≥ 10 mm in diameter at any location, or serrated polyps ≥ 5 mm in diameter proximal to the splenic flexure. All polyps are removed before patients enter the trials. The primary end point is colorectal cancer incidence after 10 years. We assume a colorectal cancer risk of 1 % for patients in EPoS I, and 2 % for patients in EPoS II. Using a noninferiority hypothesis with an equivalence interval of 0.5 % for EPoS I and 0.7 % for EPoS II, the trials are 90 % powered to uncover differences larger than the equivalence intervals. For EPoS III, no power analyses have been performed.
CONCLUSIONS


The present trials aim to develop evidence-based strategies for polyp surveillance, thereby maximizing effectiveness and minimizing resources.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02319928).",2016,"For EPoS III, no power analyses have been performed.
","['746 patients with low-risk adenomas (1\u200a-\u200a2 tubular adenomas size <\u200a10\u200amm, low-grade dysplasia) to surveillance after 5 and 10 years, or 10 years only', '704 patients with high-risk adenomas (3\u200a-\u200a10 adenomas or adenoma ≥\u200a10\u200amm in diameter, or adenoma with high-grade dysplasia, or >\u200a25\u200a% villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only', 'patients with serrated polyps ≥\u200a10\u200amm in diameter at any location, or serrated polyps ≥\u200a5\u200amm in diameter proximal to the splenic flexure']","['EPoS', 'EPoS II']",['colorectal cancer incidence'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0334292', 'cui_str': 'Tubular adenoma, no International Classification of Diseases for Oncology subtype (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0227387', 'cui_str': 'Splenic Flexure'}]",[],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",13746.0,0.140297,"For EPoS III, no power analyses have been performed.
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Jover', 'Affiliation': 'Unidad de Gastroenterología. Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Holme', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Kaminski', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Sloan Kettering Memorial Cancer Center, New York, New York, United States.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, and Harvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lansdorp-Vogelaar', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annike', 'Initials': 'A', 'LastName': 'Sunde', 'Affiliation': 'Frontier Science (Scotland) Ltd., Kingussie, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'McFadden', 'Affiliation': 'Frontier Science (Scotland) Ltd., Kingussie, United Kingdom.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castells', 'Affiliation': 'Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Quintero', 'Affiliation': 'Gastroenterology, Hospital Universitario de Canarias, La Laguna, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pellisé', 'Affiliation': 'Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Senore', 'Affiliation': 'AOU Città della Salute e della Scienza - CPO Piemonte, Turin , Italy.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Dinis-Ribeiro', 'Affiliation': 'Instituto Português de Oncologia do Porto, and CINTESIS/Faculty of Medicine, University of Porto, Porto, Portugal.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Emilsson', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Ransohoff', 'Affiliation': 'Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hoff', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hans-Olov', 'Initials': 'HO', 'LastName': 'Adami', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}]",Endoscopy,['10.1055/s-0042-104116']
1643,31559966,"Long-term changes of gut microbiota, antibiotic resistance, and metabolic parameters after Helicobacter pylori eradication: a multicentre, open-label, randomised trial.","BACKGROUND


In first-line treatment of Helicobacter pylori, we have previously shown that the eradication frequency was 83·7% (95% CI 80·4-86·6) for triple therapy for 14 days (T14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily), 85·9% (82·7-88·6) for concomitant therapy for 10 days (C10; lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily), and 90·4% (87·6-92·6) for bismuth quadruple therapy for 10 days (BQ10; bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day). In this follow-up study, we assess short-term and long-term effects of these therapies on the gut microbiota, antibiotic resistance, and metabolic parameters.
METHODS


This was a multicentre, open-label, randomised trial done at nine medical centres in Taiwan. Adult patients (>20 years) with documented H pylori infection were randomly assigned (1:1:1, with block sizes of six) to receive T14, C10, or BQ10. We assessed long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters) in patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status. Faecal samples were collected before treatment and 2 weeks, 2 months, and at least 1 year after eradication therapy. Amplification of the V3 and V4 hypervariable regions of the 16S rRNA was done followed by high-throughput sequencing. Susceptibility testing for faecal Escherichia coli and Klebsiella pneumoniae was done. This trial is complete and registered with ClinicalTrials.gov, NCT01906879.
FINDINGS


Between July 17, 2013, and April 20, 2016, 1620 participants were randomly assigned to the three treatment groups (540 [33%] per group). 1214 (75%) attended 1-year follow-up and are included in this analysis. Compared with baseline, alpha diversity was significantly reduced 2 weeks after T14 (p=0·0002), C10 (p<0·0001), and BQ10 (p<0·0001) treatment. Beta diversity was also significantly altered 2 weeks after T14 (p=0·0010), C10 (p=0·0001), and BQ10 (p=0·0001). Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029). A transient increase at week 2 after T14 and C10 of the resistance rates of E coli to ampicillin-sulbactam (12% [15/127] to 66% [38/58] for T14, 7% [10/135] to 64% [28/44] for C10), cefazolin (13% [16/127] to 43% [25/58] for T14, 10% [13/135] to 41% [18/44] for C10), cefmetazole (8% [10/127] to 26% [15/58] for T14, 4% [5/135] to 18% [8/44] for C10), levofloxacin (8% [10/127] to 35% [20/58] for T14, 7% [10/135] to 32% [14/44] for C10), gentamicin (13% [19/146] to 47% [27/58] for T14, 15% [22/149] to 45% [20/44] for C10), and trimethoprim-sulfamethoxazole (33% [48/146] to 86% [50/58] for T14, 28% [42/148] to 86% [38/44] for C10; p<0·05 in paired samples in the above analyses) returned to basal state at week 8 and after 1 year. Although bodyweight and body-mass index slightly increased, there were significant improvements in metabolic parameters, with a decrease in insulin resistance, triglycerides, and LDL and an increase in HDL. Overall, there was no significant change in the prevalence of metabolic syndrome at week 8 and 1 year after T14, C10, and BQ10.
INTERPRETATION


Eradication of H pylori infection has minimal disruption of the microbiota, no effect on antibiotic resistance of E coli, and some positive effects on metabolic parameters. Collectively, these results lend support to the long-term safety of H pylori eradication therapy.
FUNDING


National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.",2019,"Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029).","['Adult patients (>20 years) with documented H pylori infection', 'patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status', 'nine medical centres in Taiwan', '1620 participants', 'Helicobacter pylori', 'Between July 17, 2013, and April 20, 2016', 'National Taiwan University Hospital and Ministry of Science and Technology of Taiwan']","['lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole', 'cefazolin', 'levofloxacin', 'T14, C10, or BQ10', 'trimethoprim-sulfamethoxazole', 'clarithromycin', 'gentamicin', 'lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole', 'lansoprazole 30 mg, amoxicillin']","['alpha diversity', 'Alpha diversity and beta diversity', 'insulin resistance, triglycerides, and LDL and an increase in HDL', 'Beta diversity', 'gut microbiota, antibiotic resistance, and metabolic parameters', 'long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters', 'metabolic parameters', 'prevalence of metabolic syndrome', 'resistance rates of E coli to ampicillin-sulbactam', 'eradication frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1123624', 'cui_str': 'Tetracycline 500 MG'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C2930041', 'cui_str': 'Ampicillin / Sulbactam'}]",1620.0,0.144441,"Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029).","[{'ForeName': 'Jyh-Ming', 'Initials': 'JM', 'LastName': 'Liou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Chieh-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Chang', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan; Mackay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'Po-Yueh', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan; Department of Internal Medicine Fu Jen Catholic University Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Yao-Chun', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan; Department of Internal Medicine Fu Jen Catholic University Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Mei-Jyh', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chien-Chuan', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ji-Yuh', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Tsung-Hua', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine and Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Yen-Nien', 'Initials': 'YN', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Jeng-Yih', 'Initials': 'JY', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jaw-Town', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Digestive Medicine Center, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Tzu-Pin', 'Initials': 'TP', 'LastName': 'Lu', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan; Institute of Epidemiology and Preventive Medicine, Department of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Eric Y', 'Initials': 'EY', 'LastName': 'Chuang', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Emad M', 'Initials': 'EM', 'LastName': 'El-Omar', 'Affiliation': 'Microbiome Research Centre, St George & Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ming-Shiang', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: mingshiang@ntu.edu.tw.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30272-5']
1644,32416718,Experiences of integrating community volunteers as extensions of the primary care team to help support older adults at home: a qualitative study.,"BACKGROUND


Increasing the integration of community volunteers into primary health care delivery has the potential to improve person-focused, coordinated care, yet the use of volunteers in primary care is largely unexplored. Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs. This study aimed to gain an understanding of volunteer experiences within the program and client and health care provider perspectives on the volunteer role.
METHODS


This study used a qualitative descriptive approach embedded in a pragmatic randomized controlled trial. Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada. Data collection included semi-structured focus groups and interviews with all participants, and the completion of a measure of attitudes toward older adults and self-efficacy for volunteers. Qualitative data were inductively coded and analyzed using a constant comparative approach. Quantitative data were summarized using descriptive statistics.
RESULTS


Overall, 30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included. Themes included: 1. Volunteer training: ""An investment in volunteers""; 2. Intergenerational volunteer pairing: ""The best of both worlds""; 3. Understanding the volunteer role and its scope: ""Lay people involved in care""; 4. Volunteers as extensions of primary care teams: ""Being the eyes where they live""; 5. The disconnect between volunteers and the clinical team: ""Is something being done?""; 6. ""Learning… all the time"": Impacts on volunteers; and 7. Clients' acceptance of volunteers.
CONCLUSIONS


This study showed that it is possible to integrate community volunteers into the primary care setting, adding human connections to deepen the primary care team's understanding of their patients. Program implementation suggestions that emerged included: using role play in training, making volunteer role boundaries and specifications clear, and making efforts to connect volunteers and the primary care team they are supporting. This exploration of stakeholder voices has the potential to help improve volunteer program uptake and acceptability, as well as volunteer recruitment, retention, and training.
TRIAL REGISTRATION


For RCT: https://clinicaltrials.gov/ct2/show/NCT02283723, November 5, 2014.",2020,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","['30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included', 'Intergenerational volunteer pairing: ', 'older adults at home', 'Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada', 'Health Teams Advancing Patient Experience', ""volunteers; and 7. Clients' acceptance of volunteers""]","['Strengthening Quality (Health TAPESTRY', 'worlds']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],30.0,0.0198048,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gaber', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. jgaber@mcmaster.ca.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cleghorn', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Larkin', 'Initials': 'L', 'LastName': 'Lamarche', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ernie', 'Initials': 'E', 'LastName': 'Avilla', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Parascandalo', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}]",BMC family practice,['10.1186/s12875-020-01165-2']
1645,31474458,"Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial.","BACKGROUND


Pathogen resistance and safety concerns limit oral antibiotic options for the treatment of acute bacterial skin and skin structure infections (ABSSSI). We aimed to compare the efficacy and safety of once-daily oral omadacycline, an aminomethylcycline antibiotic, versus twice-daily oral linezolid for treatment of ABSSSI.
METHODS


In this phase 3, double-blind, randomised, non-inferiority study, eligible adults with ABSSSI at 33 sites in the USA were randomly assigned (1:1) to receive omadacycline (450 mg orally every 24 h over the first 48 h then 300 mg orally every 24 h) or linezolid (600 mg orally every 12 h) for 7-14 days. Randomisation was done via an interactive response system using a computer-generated schedule, and stratified by type of infection (wound infection, cellulitis or erysipelas, or major abscess) and receipt (yes or no) of allowed previous antibacterial treatment. Investigators, funders, and patients were masked to treatment assignments. Primary endpoints were early clinical response, 48-72 h after first dose, in the modified intention-to-treat (mITT) population (randomised patients without solely Gram-negative ABSSSI pathogens at baseline), and investigator-assessed clinical response at post-treatment evaluation, 7-14 days after the last dose, in the mITT population and clinically evaluable population (ie, mITT patients who had a qualifying infection as per study-entry criteria, received study drug, did not receive a confounding antibiotic, and had an assessment of outcome during the protocol-defined window). The safety population included randomised patients who received any amount of study drug. We set a non-inferiority margin of 10%. This study is registered with ClinicalTrials.gov, NCT02877927, and is complete.
FINDINGS


Between Aug 11, 2016, and June 6, 2017, 861 participants were assessed for eligibility. 735 participants were randomly assigned, of whom 368 received omadacycline and 367 received linezolid. Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (percentage-point difference 5·0, 95% CI -0·2 to 10·3) in the mITT population. For investigator-assessed clinical response at post-treatment evaluation, omadacycline was non-inferior to linezolid in the mITT (303 [84%] of 360 vs 291 [81%] of 360; percentage-point difference 3·3, 95% CI -2·2 to 9·0) and clinically evaluable (278 [98%] of 284 vs 279 [96%] of 292; 2·3, -0·5 to 5·8) populations. Mild to moderate nausea and vomiting were the most frequent treatment-emergent adverse events in omadacycline (111 [30%] of 368 and 62 [17%] of 368, respectively) and linezolid (28 [8%] of 367 and 11 [3%] of 367, respectively) groups.
INTERPRETATION


Once-daily oral omadacycline was non-inferior to twice-daily oral linezolid in adults with ABSSSI, and was safe and well tolerated. Oral-only omadacycline represents a new treatment option for ABSSSI, with potential for reduction in hospital admissions and cost savings.
FUNDING


Paratek Pharmaceuticals.",2019,Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (,"['acute bacterial skin and skin structure infections (OASIS-2', '861 participants were assessed for eligibility', 'eligible adults with ABSSSI at 33 sites in the USA', '735 participants', 'Between Aug 11, 2016, and June 6, 2017']","['linezolid', 'Omadacycline', 'Oral-only omadacycline', 'omadacycline versus twice-daily oral linezolid', 'omadacycline']","['moderate nausea and vomiting', 'efficacy and safety', 'safe and well tolerated']","[{'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",735.0,0.503444,Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Riordan"", 'Affiliation': 'eStudySite, San Diego, CA, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cardenas', 'Affiliation': 'eStudySite, San Diego, CA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Jubilee Clinical Research, Las Vegas, NV, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Sirbu', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Garrity-Ryan', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA. Electronic address: lynne.garrity-ryan@paratekpharma.com.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stats Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manley', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Judith N', 'Initials': 'JN', 'LastName': 'Steenbergen', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Tzanis', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'McGovern', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Loh', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30275-0']
1646,31556078,Influence of Postoperative Patient-Controlled Analgesia on Hemorheology in Patients Undergoing Hip Arthroplasty.,"OBJECTIVE


To test the hypothesis that patient-controlled analgesia (PCA) contributes to improvement of hemorheology in patients undergoing hip arthroplasty.
METHODS


120 patients, aged 60 - 75 years old, undergoing hip arthroplasty under spinal anesthesia, were randomly divided into group PCA (n = 60) and control group (n = 60). Patients in PCA group received PCA in postoperative 3 days. Blood samples from the median cubital vein were collected at five time points: before anesthesia (T1), after surgery (T2), 6 h after surgery (T3), 24 h after surgery (T4), 48 h after surgery (T5). Hemorheological parameters were measured, including whole blood viscosity at a high shear rate (Hηb), whole blood viscosity at a low shear rate (Lηb), reduced viscosity (ηr), plasma viscosity (ηp), hematocrit (Hct), erythrocyte aggregation index(EAI) and erythrocyte deformation index (EDI). Noninvasive blood pressure and heart rate at T1-5 and pain scoring of visual analogue scale (VAS) score at T2-5 were recorded.
RESULTS


(1) Compared with T1, Hηb, Lηb, ηp, ηr decreased significantly at T3-5 with EAI decreased significantly at T5 in group PCA (p < 0.05), EDI increased significantly at T5 in group C (p < 0.05). (2) Compared with group C, Hηb, Lηb, ηp, ηr, EAI decreased significantly at T5 with Lηb concurrently decreased at T4 in group PCA (p < 0.05).
CONCLUSION


Postoperative pain may increase blood viscosity in patients undergoing hip arthroplasty, mainly via plasma viscosity, erythrocyte aggregation and rigidity, and which could be improved by postoperative PCA.",2020,"(1) Compared with T1, Hηb, Lηb, ηp, ηr decreased significantly at T3-5 with EAI decreased significantly at T5 in group PCA (p < 0.05), EDI increased significantly at T5 in group C (p < 0.05).","['patients undergoing hip arthroplasty', '120 patients, aged 60\u200a-\u200a75 years old, undergoing hip arthroplasty under spinal anesthesia', 'Patients Undergoing Hip Arthroplasty']","['PCA', 'Postoperative Patient-Controlled Analgesia', 'patient-controlled analgesia (PCA']","['whole blood viscosity at a high shear rate (Hηb), whole blood viscosity at a low shear rate (Lηb), reduced viscosity (ηr), plasma viscosity (ηp), hematocrit (Hct), erythrocyte aggregation index(EAI) and erythrocyte deformation index (EDI', 'EDI', 'blood viscosity', 'Hemorheological parameters', 'Noninvasive blood pressure and heart rate at T1-5 and pain scoring of visual analogue scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}]","[{'cui': 'C0427691', 'cui_str': 'Whole blood viscosity measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C1287278', 'cui_str': 'Finding of plasma viscosity (finding)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1608880', 'cui_str': 'Erythrocyte aggregation (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0005848', 'cui_str': 'Blood Viscosity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",120.0,0.0363218,"(1) Compared with T1, Hηb, Lηb, ηp, ηr decreased significantly at T3-5 with EAI decreased significantly at T5 in group PCA (p < 0.05), EDI increased significantly at T5 in group C (p < 0.05).","[{'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Anesthesiology, Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Anesthesiology, Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Luan', 'Affiliation': 'Vanderbilt University Medical Center, Department of Anesthesiology, Nashville, United States.'}, {'ForeName': 'Daiying', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Operating Room, Affiliated Hospital of Southwest Medical University, Luzhou, China.'}]",Zeitschrift fur Orthopadie und Unfallchirurgie,['10.1055/a-0918-6603']
1647,31023864,The importance of differentiating behavioural and psychological treatment effects from placebo in respiratory interventions.,,2019,,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0305291,,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': 'Dept of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK b.ainsworth@bath.ac.uk.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Hardman', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Bath, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Bath, UK.'}]",The European respiratory journal,['10.1183/13993003.00156-2019']
1648,32417382,Randomized open-label trial of intravenous brivaracetam versus lorazepam for acute treatment of increased seizure activity.,"OBJECTIVE


The objective of the present trial was to assess efficacy and safety of intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP) in patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment.
METHODS


This was a phase 2, open-label, randomized, active-control, proof-of-concept trial (EP0087; NCT03021018). Patients (18-70 years) admitted to EMU were randomized 1:1:1 to single-dose bolus IV LZP (dose per investigator's practice), IV BRV 100 mg, or IV BRV 200 mg. Trial medication had to be administered within 30 min of qualifying seizure. Primary efficacy outcome was time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12 h of trial medication administration. Secondary outcomes included seizure freedom and rescue medication use within 12 h of trial medication administration. Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs).
RESULTS


Overall, 46 patients were randomized, and 45 received trial medication for a qualifying seizure. Patients in the LZP arm had doses from 1 to 4 mg (median: 1 mg). Eleven of 45 patients had a seizure within 12 h of trial medication administration (LZP 5/15 [median time to next seizure: 5.55 h], BRV 100 mg 3/15 [5.97 h], BRV 200 mg 3/15 [3.60 h]). No patients received additional rescue medication to control their qualifying seizure. Most patients were seizure-free over 12 h (LZP 9/15 [60.0%], BRV 100 mg 12/15 [80.0%], BRV 200 mg 12/15 [80.0%]). Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]) vs. BRV 100 mg (1/15 [6.7%]) and vs. BRV 200 mg (2/15 [13.3%]). Treatment-emergent adverse events were reported by 5/16 (31.3%), 6/15 (40.0%), and 3/15 (20.0%) of LZP, BRV 100 mg, and BRV 200 mg patients; one LZP patient had a serious TEAE (seizure cluster). Most common TEAEs (≥10% of patients) were sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV.
SIGNIFICANCE


Intravenous LZP, IV BRV 100 mg, and IV BRV 200 mg showed similar efficacy in controlling acute seizure activity in the EMU. Treatment-emergent adverse events were as expected for each medication. Although this trial should be interpreted with caution because of small patient numbers, it suggests a possible role of BRV in the acute treatment of increased seizure activity.",2020,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"['patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment', 'Patients (18-70\u202fyears) admitted to EMU', 'Eleven of 45 patients had a seizure within 12\u202fh of trial medication administration ', '46 patients']","['intravenous brivaracetam versus lorazepam', 'intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP', 'single-dose bolus IV LZP', 'LZP']","['time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12\u202fh of trial medication administration', 'acute seizure activity', 'sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV', 'seizure activity', 'seizure-free', 'Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs', 'Treatment-emergent adverse events', 'efficacy and safety', 'seizure freedom and rescue medication use within 12\u202fh of trial medication administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",46.0,0.224115,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"[{'ForeName': 'Jerzy P', 'Initials': 'JP', 'LastName': 'Szaflarski', 'Affiliation': 'University of Alabama at Birmingham, Department of Neurology and the UAB Epilepsy Center, 1719 6th Avenue South, CIRC 312, Birmingham, AL 35294, USA. Electronic address: jszaflarski@uabmc.edu.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sadek', 'Affiliation': 'Neurological Services of Orlando, 3849 Oakwater Cir, Orlando, FL 32806, USA. Electronic address: ahsadek@mac.com.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Greve', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Straße 10, 40789 Monheim am Rhein, Germany. Electronic address: bernhard.greve@ucb.com.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: paulette.williams@ucb.com.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Varner', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: julie.varner@ucb.com.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Moseley', 'Affiliation': 'University of Cincinnati, 260 Stetson Street, Suite 2300, Cincinnati, OH 45267-0525, USA. Electronic address: briandmoseley@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107127']
1649,30738709,"Reply to Jae Heon Kim and Benjamin I. Chung's Letter to the Editor re: Teemu J. Murtola, Heimo Syvälä, Teemu Tolonen, et al. Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial. Eur Urol 2018;74:697-701.",,2019,,['Prostate Cancer'],"['Placebo', 'Atorvastatin Versus Placebo']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",[],,0.26218,,"[{'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland; Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland. Electronic address: teemu.murtola@uta.fi.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Syvälä', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}]",European urology,['10.1016/j.eururo.2019.01.044']
1650,31551155,Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial.,"OBJECTIVE


To evaluate the benefit of next-generation sequencing (NGS)-based preimplantation genetic testing for aneuploidy (PGT-A) for embryo selection in frozen-thawed embryo transfer.
DESIGN


Randomized controlled trial.
SETTING


Not applicable.
PATIENT(S)


Women aged 25-40 years undergoing IVF with at least two blastocysts that could be biopsied.
INTERVENTION(S)


Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer.
RESULT(S)


A total of 661 women (average age 33.7 ± 3.6 years) were randomized to PGT-A (n = 330) or morphology alone (n = 331). The OPR was equivalent between the two arms, with no significant difference per embryo transfer (50% [137/274] vs. 46% [143/313]) or per intention to treat (ITT) at randomization (41.8% [138/330] vs. 43.5% [144/331]). Post hoc analysis of women aged 35-40 years showed a significant increase in OPR per embryo transfer (51% [62/122] vs. 37% [54/145]) but not per ITT.
CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT. There was a significant increase in OPR per embryo transfer with the use of PGT-A in the subgroup of women aged 35-40 years who had two or more embryos that could be biopsied, but this was not significant when analyzed by ITT.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02268786.",2019,"CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT.","['Women aged 25-40\xa0years undergoing IVF with at least two blastocysts that could be biopsied', 'good-prognosis patients', '661 women (average age 33.7 ± 3.6\xa0years']","['morphology alone', 'next-generation sequencing (NGS)-based preimplantation genetic testing', 'Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology']","['OPR', 'Ongoing pregnancy rate (OPR', 'embryo transfer', 'overall pregnancy outcomes', 'OPR per embryo transfer']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}]",661.0,0.230078,"CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Munné', 'Affiliation': 'Cooper Genomics, Livingston, New Jersey; Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': 'Highland Park IVF Center, Fertility Centers of Illinois, Highland Park, Illinois.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Frattarelli', 'Affiliation': 'Fertility Institute of Hawaii, Honolulu, Hawaii.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Child', 'Affiliation': 'Oxford Fertility, Oxford, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Nakhuda', 'Affiliation': 'Olive Fertility Center, Vancouver, British Columbia, Canada.'}, {'ForeName': 'F Nicholas', 'Initials': 'FN', 'LastName': 'Shamma', 'Affiliation': 'IVF Michigan, Bloomfield Hills, Michigan.'}, {'ForeName': 'Kaylen', 'Initials': 'K', 'LastName': 'Silverberg', 'Affiliation': 'Texas Fertility Center, Austin, Texas; Ovation Fertility, Los Angeles, California.'}, {'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Kalista', 'Affiliation': 'Illumina, Foster City, California.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Handyside', 'Affiliation': 'School of Biosciences, University of Kent, Canterbury, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Katz-Jaffe', 'Affiliation': 'Colorado Center for Reproductive Medicine, Lone Tree, Colorado.'}, {'ForeName': 'Dagan', 'Initials': 'D', 'LastName': 'Wells', 'Affiliation': 'Reprogenetics, Oxford, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Gordon', 'Affiliation': 'Cooper Genomics, London, United Kingdom.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Stock-Myer', 'Affiliation': 'Melbourne IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Willman', 'Affiliation': 'Reproductive Science Center, San Ramon, California. Electronic address: susan@susanwillman.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.1346']
1651,31559916,Does Discrimination Breed Mistrust? Examining the Role of Mediated and Non-Mediated Discrimination Experiences in Medical Mistrust.,"Medical mistrust is associated with a decreased likelihood of engaging in various health behaviors, including health utilization and preventive screening. Despite calls for research to address medical mistrust, few studies have explicitly delved into antecedents to medical mistrust. The current study a) examines the relationship between discrimination experiences and medical mistrust and b) experimentally tests the influence of mediated vicarious discrimination on reported levels of medical mistrust. Participants ( N  = 198) were randomly assigned to view news stories in one of four experimental conditions: no exposure, no discrimination control, implicit racial discrimination, and explicit racial discrimination. Results indicated prior personal and vicarious discrimination experiences were related to medical mistrust. Furthermore, exposure to mediated discrimination influenced medical mistrust in different ways for Black and White participants. Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition. Marginal differences were found for White participants such that those exposed to both explicit and implicit racial discrimination conditions reported higher medical mistrust than those exposed to the control condition. Our findings are discussed in terms of the theoretical and practical implications for health communication scholars seeking to examine and influence health behaviors.",2019,"Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition.",['Participants ( N  =\xa0198'],"['view news stories in one of four experimental conditions: no exposure, no discrimination control, implicit racial discrimination, and explicit racial discrimination']",[],[],"[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205905', 'cui_str': 'Racial Prejudice'}]",[],,0.0111156,"Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition.","[{'ForeName': 'Lillie D', 'Initials': 'LD', 'LastName': 'Williamson', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Marisa A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Cabral A', 'Initials': 'CA', 'LastName': 'Bigman', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1669742']
1652,32416611,A comparative clinical and histopathological pilot study of different fractional CO 2  laser parameters in treatment of atrophic linear scars.,"BACKGROUND


Atrophic scars cause significant patient morbidity. Fractional photothermolysis is one of the most effective treatment options used to resurface scars of different etiologies.
AIMS


To assess the efficacy and safety of different fractional ablative CO 2  laser parameters in treatment of linear atrophic depressed post-traumatic facial scars in adult male patients.
METHODS


A prospective pilot study of 20 adult male patients (skin types Π- Ⅳ, aged 18-45) with post-traumatic atrophic linear scars were divided into 2 groups each comprising 10 patients receiving different fractional CO 2  laser parameters. Both groups received 3 laser sessions, one month apart, and were followed for 2 months after the last treatment session. Clinical and histological assessments were done to all patients before treatment and 2 months after the last treatment session. Also, patient satisfaction and side effects were recorded.
RESULTS


The study showed statistically significant reduction in average scar volume in both groups (P < .01), with reduction in depth more obvious than reduction in width or length in both groups. There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P < .01) with an average reduction in scar volume of 42.85% in group (a) compared with 35.29% in group (b). Also, there was a highly statistically significant increase in both epidermal and papillary and reticular dermis thickness in both groups after treatment. However, the difference between both groups was nonsignificant. Side effects were mild, well tolerated, and transient.
CONCLUSION


Fractional CO 2  laser can be utilized as a safe and effective modality in treatment of post-traumatic linear atrophic scars of the face. Adjusting parameters toward increasing depth of penetration and decreasing thermal coagulative effect gives better results.",2020,There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P<0.01) with an average reduction in scar volume of 42.85 % in group (1) compared to 35.29 % in group (2).,"['20 adult male patients (skin types Π- Ⅳ, aged 18-45) with post traumatic atrophic linear scars', 'atrophic linear scars', 'linear atrophic depressed post-traumatic facial scars in adult male patients']","['fractional ablative CO 2  Laser parameters', 'fractional CO2 laser parameters']","['average scar volume', 'scar volume', 'patient satisfaction and side effects', 'both epidermal, papillary and reticular dermis thickness', 'efficacy and safety', 'tolerated and transient', 'width or length', 'overall scar improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",20.0,0.01976,There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P<0.01) with an average reduction in scar volume of 42.85 % in group (1) compared to 35.29 % in group (2).,"[{'ForeName': 'Ahmad I', 'Initials': 'AI', 'LastName': 'Rasheed', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Sylvia R', 'Initials': 'SR', 'LastName': 'Shawki', 'Affiliation': 'Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Rabab G', 'Initials': 'RG', 'LastName': 'Mostafa', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Manal A', 'Initials': 'MA', 'LastName': 'Sharara', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13489']
1653,31034999,Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU).,,2019,,['chronic idiopathic urticaria'],['omalizumab'],[],"[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}]",[],,0.0127888,,"[{'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Murphy', 'Affiliation': 'Charleston ENT and Allergy, Charleston, SC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holden', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Yamina', 'Initials': 'Y', 'LastName': 'Rajput', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif. Electronic address: rajput.yamina@gene.com.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center and University of Cincinnati, Cincinnati, Ohio.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.04.020']
1654,32417634,"Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial.","BACKGROUND


A low intake of selenium has been shown to increase the risk of cardiovascular mortality, and supplementation of selenium and coenzyme Q10 influences this. The mechanism behind is unclear although effects on inflammation, oxidative stress and microRNA expression have been reported. Fructosamine, a marker of long-term glycaemic control, is also a marker of increased risk of heart disease and death, even in non-diabetics.
OBJECTIVE


To analyse the impact of selenium and coenzyme Q10 supplementation on the concentration of fructosamine. Also, the relation between pre-intervention serum selenium concentration and the effect on fructosamine of the intervention was studied.
METHODS


Fructosamine plasma concentration was determined in 219 participants after six and 42 months of intervention with selenium yeast (200 μg/day) and coenzyme Q10 (200 mg/ day) (n = 118 of which 20 had diabetes at inclusion), or placebo (n = 101 of which 18 had diabetes at inclusion). Pre-intervention, the serum selenium levels were 67 μg/L (active treatment group: 66.6 μg/L; placebo group: 67.4 μg/L), corresponding to an estimated intake of 35 μg/day. Changes in concentrations of fructosamine following intervention were assessed by the use of T-tests, repeated measures of variance, and ANCOVA analyses.
RESULTS


Post-intervention selenium concentrations were 210 μg/L in the active group and 72 μg/L in the placebo group. A lower concentration of fructosamine could be seen as a result of the intervention in the total population (P = 0.001) in both the males (P = 0.04) and in the females (P = 0.01) in the non-diabetic population (P = 0.002), and in both the younger (<76 years) (P = 0.01) and the older (≥76 years) participants (P = 0.03). No difference could be demonstrated in fructosamine concentration in the diabetic patients, but the total sample was small (n = 38). In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
CONCLUSION


A significantly lower concentration of fructosamine was observed in the elderly community-living participants supplemented with selenium and coenzyme Q10 for 42 months compared to those on the placebo. As oxidative mechanisms are involved in the glycation of proteins, less glycoxidation could be a result of the supplementation of selenium and coenzyme Q10, which could have contributed to lower cardiac mortality and less inflammation, as has earlier been reported. This study was registered at Clinicaltrials.gov, and has the identifier NCT01443780.",2020,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","['219 participants after six and 42 months of intervention with selenium yeast (200\u202fμg/day) and', 'elderly population with low selenium status - A four-year', '\u202f101 of which 18 had diabetes at inclusion']","['Fructosamine', 'selenium and coenzyme Q10', 'coenzyme Q10 ', 'selenium and coenzyme Q10 supplementation', 'placebo (n', 'Supplemental selenium and coenzyme Q10 reduce glycation', 'placebo']","['serum selenium levels', 'fructosamine', 'concentration of fructosamine', 'fructosamine concentration']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.328184,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. Electronic address: Urban.Alehagen@liu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, N-2381 Brumunddal, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, P.O. Box 222 Skøyen, N-0213 Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Social and Welfare studies. Department of Medical and Health Sciences, Linköping University, SE-601 74 Norrköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, SE-751 85 Uppsala, Sweden.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126541']
1655,29401230,Differential Age Effects of Transcranial Direct Current Stimulation on Associative Memory.,"OBJECTIVES


Older adults experience associative memory deficits relative to younger adults (Old & Naveh-Benjamin, 2008). The aim of this study was to test the effect of transcranial direct current stimulation (tDCS) on face-name associative memory in older and younger adults.
METHOD


Experimenters applied active (1.5 mA) or sham (0.1 mA) stimulation with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) during a face-name encoding task, and measured both cued recall and recognition performance. Participants completed memory tests immediately after stimulation and after a 24-h delay to examine both immediate and delayed stimulation effects on memory.
RESULTS


Results showed improved face-name associative memory performance for both recall and recognition measures, but only for younger adults, whereas there was no difference between active and sham stimulation for older adults. For younger adults, stimulation-induced memory improvements persisted after a 24-h delay, suggesting delayed effects of tDCS after a consolidation period.
DISCUSSION


Although effective in younger adults, these results suggest that older adults may be resistant to this intervention, at least under the stimulation parameters used in the current study. This finding is inconsistent with a commonly seen trend, where tDCS effects on cognition are larger in older than younger adults.",2019,"Results


Results showed improved face-name associative memory performance for both recall and recognition measures, but only for younger adults, whereas there was no difference between active and sham stimulation for older adults.","['older and younger adults', 'Older adults experience associative memory deficits relative to younger adults (Old & Naveh-Benjamin, 2008', 'younger adults']","['transcranial direct current stimulation (tDCS', 'Method\n\n\nExperimenters applied active (1.5 mA) or sham (0.1 mA) stimulation with the anode placed over the left dorsolateral prefrontal cortex (dlPFC', 'Transcranial Direct Current Stimulation']","['Associative Memory', 'face-name associative memory performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0442989', 'cui_str': 'Benjamin (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",,0.0427932,"Results


Results showed improved face-name associative memory performance for both recall and recognition measures, but only for younger adults, whereas there was no difference between active and sham stimulation for older adults.","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Leach', 'Affiliation': 'Loyola University Chicago.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'McCurdy', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Trumbo', 'Affiliation': 'Sandia National Laboratories.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Matzen', 'Affiliation': 'Sandia National Laboratories.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Leshikar', 'Affiliation': 'University of Illinois at Chicago.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby003']
1656,30655452,Sertraline or placebo in chronic breathlessness? Lessons from placebo research.,,2019,,[],"['Sertraline or placebo', 'placebo']",[],[],"[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.21493,,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}]",The European respiratory journal,['10.1183/13993003.02316-2018']
1657,32416715,Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial.,"BACKGROUND


To obtain information on feasibility and acceptability, as well as preliminary data on efficacy, of an Osteoarthritis Physical activity Care Pathway (OA-PCP).
METHODS


This was a single group pilot study involving 60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics. Participants self-reported completing less than 150 min per week of moderate-to-vigorous physical activity (MVPA) at baseline. The 3-month OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with community-based or online resources to support PA. Efficacy outcomes were collected at baseline and 4-month follow-up. The primary efficacy outcome was minutes of MVPA, assessed via accelerometer. Secondary outcomes included minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales. Participants were also asked to rate the helpfulness of the OA-PCP intervention on a scale of 0-10. Differences in efficacy outcomes between baseline and 4-month follow-up were assessed using paired t-tests.
RESULTS


Among participants beginning the study, 88% completed follow-up assessments and ≥ 90% completed each of the intervention calls. Average daily minutes of MVPA was 8.0 at baseline (standard deviation (SD) = 9.9) and 8.9 at follow-up (SD = 12.1, p = 0.515). There were no statistically significant changes in light intensity activity, sedentary time or step counts. The mean WOMAC pain score improved from 8.1 (SD = 3.6) at baseline to 6.2 (SD = 3.8) at follow-up (p < 0.001); the mean WOMAC function score improved from 26.2 (SD = 13.2) to 20.2 (SD = 12.5; p < 0.001). The mean rating of helpfulness was 7.6 (SD = 2.5).
CONCLUSIONS


Results supported the feasibility and acceptability of the study, and participants reported clinically relevant improvements in pain and function. PA metrics did not improve substantially. Based on these results and participant feedback, modifications including enhanced self-monitoring are being made to increase the impact of the OA-PCP intervention on PA behavior.
TRIAL REGISTRATION


NCT03780400, December 19, 2018.",2020,"There were no statistically significant changes in light intensity activity, sedentary time or step counts.","['60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics']","['Osteoarthritis physical activity care pathway (OA-PCP', 'OA-PCP intervention', 'OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with community-based or online resources to support PA']","['mean WOMAC function score', 'minutes of MVPA, assessed via accelerometer', 'feasibility and acceptability', 'light intensity activity, sedentary time or step counts', 'Average daily minutes of MVPA', 'mean WOMAC pain score', 'pain and function', 'Efficacy outcomes', 'minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales', 'mean rating of helpfulness', 'efficacy outcomes', 'PA metrics']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",60.0,0.048199,"There were no statistically significant changes in light intensity activity, sedentary time or step counts.","[{'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA. kdallen@email.unc.edu.'}, {'ForeName': 'Maihan B', 'Initials': 'MB', 'LastName': 'Vu', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, 1700 M.L.K. Jr Blvd #7426, Chapel Hill, NC, USA.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'Departments of Medicine, Orthopaedics and Social Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Cleveland', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Gilbert', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Golightly', 'Affiliation': 'Department of Epidemiology, Injury Prevention Research Center, Division of Physical Therapy and Thurston Arthritis Research Center, |University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, 170 Rosenau Hall, CB #7600, Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberlea', 'Initials': 'K', 'LastName': 'Grimm', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition Gillings School of Global Public Health and Center for Health Promotion and Disease Prevention, University of North Carolina, 1700 M.L.K. Jr Blvd #7426, Chapel Hill, NC, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Huffman', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Medical Facilities of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'North Carolina Translational and Clinical Sciences Institute, School of Medicine, University of North Carolina, Brinkhous-Bullitt Building, 160 Medical Dr, Chapel Hill, NC, USA.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Rethorn', 'Affiliation': 'Department of Orthopedic Surgery, Duke University, 311 Trent Drive, Durham, NC, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Wandishin', 'Affiliation': 'Department of Exercise and Sport Science and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, #7280, USA.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03339-6']
1658,31420292,Intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis: a cost-effectiveness analysis.,"BACKGROUND


Outpatient parenteral antibiotic therapy after hospital admission is increasingly popular, but its use to avoid admission to hospital altogether by treating patients wholly as outpatients remains uncommon in children. One reason for the low use of treatment at home is the scarcity of evidence of its cost-effectiveness. In this planned follow-up analysis of the Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial, we aimed to assess the cost-effectiveness of an admission avoidance pathway, in which children were treated at home, compared with standard hospital care for the intravenous treatment of moderate or severe cellulitis.
METHODS


We did a cost-effectiveness analysis to compare home treatment with intravenous ceftriaxone versus hospital treatment with intravenous flucloxacillin in children aged 6 months to 18 years who had presented to the emergency department at The Royal Children's Hospital, Melbourne, VIC, Australia, with moderate or severe uncomplicated cellulitis. We included costs from two sources: institutional costs at a patient level and expenses incurred by families. We measured effectiveness with quality-adjusted life years (QALYs), which we derived from the Child Health Utility 9D questionnaire, and a clinical outcome of treatment failure, which was the primary outcome of the CHOICE trial. We planned to calculate the incremental cost-effectiveness ratio, defined as the difference between groups in total cost divided by the difference between groups in effectiveness. The CHOICE trial is registered at ClinicalTrials.gov, number NCT02334124.
FINDINGS


We included 180 children who comprised the per-protocol population in the CHOICE trial: 89 children in the home group and 91 children in the hospital group. The institutional cost per patient per episode was significantly lower in the home group than in the hospital group (AUS$1965 vs $3775; p<0·0001). The mean cost incurred per family was $182 for the home group and $593 for the hospital group (p<0·0001). Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029). Calculating the incremental cost-effectiveness ratio was thus deemed redundant.
INTERPRETATION


Treatment at home was less costly and more effective than standard hospital care for children with moderate or severe cellulitis. These findings support development of this admission avoidance pathway in hospitals.
FUNDING


The Royal Children's Hospital Foundation, Murdoch Children's Research Institute.",2019,"Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029).","[""children aged 6 months to 18 years who had presented to the emergency department at The Royal Children's Hospital, Melbourne, VIC, Australia, with moderate or severe uncomplicated cellulitis"", 'children with moderate or severe cellulitis', 'children with cellulitis', '180 children who comprised the per-protocol population in the CHOICE trial: 89 children in the home group and 91 children in the hospital group']","['intravenous flucloxacillin', 'Intravenous ceftriaxone', 'ceftriaxone', 'flucloxacillin']","['treatment failure', 'institutional cost per patient per episode', 'mean cost incurred per family', 'effectiveness with quality-adjusted life years (QALYs', 'incremental cost-effectiveness ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0162643'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",180.0,0.127728,"Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029).","[{'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Ibrahim', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Centre for Health Policy, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dalziel', 'Affiliation': 'Centre for Health Policy, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Bryant', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Hospital-In-The-Home Department, The Royal Children's Hospital, Melbourne, VIC, Australia. Electronic address: penelope.bryant@rch.org.au.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30288-9']
1659,31272834,"Effects of Mokuboito, a Japanese Kampo medicine, on symptoms in patients hospitalized for acute decompensated heart failure - A prospective randomized pilot study.","BACKGROUND


Although standard treatment for heart failure (HF) has been established, it remains difficult to relieve HF-associated symptoms in some patients. Kampo medicines have been used to treat various diseases; however, it remains unclear whether they are effective in HF patients. We therefore performed a prospective, randomized, controlled trial to investigate whether Mokuboito, a Kampo medicine, affected symptoms and other parameters in hospitalized patients with acute decompensated HF (ADHF), as compared to standard therapy alone.
METHODS


Forty patients were allocated randomly to Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy). The primary outcome was changes in global clinical status based on a visual analog scale (VAS) from baseline at day 10 or discharge if earlier.
RESULTS


The decrease in VAS score was significantly greater in Group M than Group S (p=0.001). Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload.
CONCLUSIONS


Oral administration of Mokuboito significantly improved ADHF-related symptoms. Our observations might provide the basis for a novel therapeutic strategy in hospitalized patients with ADHF.",2019,"Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload.
","['hospitalized patients with acute decompensated HF (ADHF', 'heart failure (HF', 'patients hospitalized for acute decompensated heart failure ', 'Forty patients', 'hospitalized patients with ADHF']","['Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy', 'Mokuboito, a Japanese Kampo medicine']","['ADHF-related symptoms', 'VAS score', 'body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels', 'global clinical status based on a visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}]","[{'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0752221', 'cui_str': 'Kanpo'}]","[{'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0541978,"Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Ezaki', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan. Electronic address: hirotakaezaki@gmail.com.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayaori', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Oita Oka Hospital, Oita, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Maeno', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Miyake', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.05.003']
1660,31035859,Statistical inference problems in sequential parallel comparison design.,"The sequential parallel comparison designhas recently been considered to solve the problem with high placebo response and the required sample size in the psychiatric clinical trials. One feature with this design is that a difference between the placebo group and the drug group may also arise in the variance-covariance structure of the clinical outcome. Provided the heterogeneity of the second moment, the treatment effect estimation at the second stage can be biased for the entire randomized patient population that includes patient responders. Our work presented here aims at how the coverage probability of the interval estimation of treatment effect performs under the unstructured variance-covariance matrix. The interaction between the truncation after the first stage and the heterogeneity of the second moment causes a substantial coverage probability problem. The type I error probability may not be controlled under the weak null due to this bias. This bias can also cause spurious power evaluation under an alternative hypothesis. The coverage probability of the ordinary least square statistic is shown in different scenarios.",2019,The coverage probability of the ordinary least square statistic is shown in different scenarios.,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],1.0,0.0652093,The coverage probability of the ordinary least square statistic is shown in different scenarios.,"[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Statistics, The Wharton School, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Semhar', 'Initials': 'S', 'LastName': 'Ogbagaber', 'Affiliation': 'Division of Biometric I, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.'}, {'ForeName': 'H M James', 'Initials': 'HMJ', 'LastName': 'Hung', 'Affiliation': 'Division of Biometric I, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1609014']
1661,32420825,Group social work intervention enhances the sexual satisfaction of women with Multiple Sclerosis: a randomized controlled trial study.,"Sexual problems are among the most common disorders that people with Multiple Sclerosis have to deal with, resulting in decreased sexual satisfaction and quality of life. The study is aimed to investigate the impact of group social work intervention on the sexual satisfaction of women with Multiple Sclerosis. The methodology was a randomized controlled trial and 58 participants recruited (30 for control group and 28 for intervention group). The intervention was based on group social work with an empowerment approach within eight sessions. The average age of the participants was 35.95 ± 6.41 most of whom had high school diploma (62.1%). The findings indicate that, in terms of sexual satisfaction (t = 5.47, Sig = 0.03, df = 56), primary disorders (t = 2.42, Sig = 0.019, df = 56), and tertiary disorders (t = 3.77, Sig = 0.002, df = 56), there is a significant difference between intervention and control groups.",2020,", there is a significant difference between intervention and control groups.","['The average age of the participants was 35.95\xa0±', 'df\xa0=\xa056', 'women with Multiple Sclerosis', '58 participants recruited (30 for control group and 28 for intervention group']",['social work intervention'],"['sexual satisfaction', 'sexual satisfaction and quality of life', 'tertiary disorders']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",58.0,0.0694324,", there is a significant difference between intervention and control groups.","[{'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Arshi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Sheybani', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Eghlima', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shati', 'Affiliation': 'Mental Health Research Center, Social Injury Prevention Research Institute, Iran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Moghanibashi-Mansourieh', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moshayyedi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}]",Social work in health care,['10.1080/00981389.2020.1762148']
1662,31549793,Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early Rheumatoid Arthritis With Poor Prognosis.,"OBJECTIVE


High magnetic resonance imaging (MRI)-detected inflammation is associated with greater progression and poorer outcomes in rheumatoid arthritis (RA). This analysis aimed to determine if baseline MRI inflammation was related to clinical response and remission in the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) study.
METHODS


AVERT was a phase IIIb, randomized, controlled trial with a 12-month, double-blind treatment period enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naive RA. In this post hoc analysis, patients in the abatacept plus MTX (n = 114) and MTX (n = 111) arms with available MRI results were stratified into low and high baseline MRI inflammation groups based on previously developed cutoffs of synovitis and osteitis on unilateral hand-wrist contrast-enhanced MRI. Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints using the C-reactive protein level (<2.6) were assessed.
RESULTS


Overall, 100 of 225 patients (44.4%) had high baseline MRI inflammation. In patients with high baseline MRI inflammation, a significantly greater proportion achieved remission at 12 months with abatacept plus MTX versus MTX across SDAI (45.1% versus 16.3%; P = 0.0022), CDAI (47.1% versus 20.4%; P = 0.0065), and Boolean indices (39.2% versus 16.3%; P = 0.0156). In patients with low baseline MRI inflammation, remission rates were not significantly different with abatacept plus MTX versus MTX (SDAI: 39.7% versus 32.3%; P = 0.4961).
CONCLUSION


In seropositive, MTX-naive patients with early RA and presence of objectively measured high inflammation by MRI, indicating poor prognosis, remission rates were higher with abatacept plus MTX treatment versus MTX.",2019,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[""enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naïve RA""]","['MTX', 'abatacept+MTX treatment versus MTX', 'Magnetic Resonance Imaging', 'magnetic resonance imaging', 'abatacept+MTX versus MTX', 'abatacept+MTX']","['Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score', 'remission rates', 'Boolean indices', 'CDAI', 'remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",,0.295007,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[{'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Baker', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Rigshospitalet, Glostrup, Denmark, and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Durez', 'Affiliation': 'Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}]",Arthritis care & research,['10.1002/acr.24072']
1663,32418538,The impact of a cartoon character on adults perceptions of Children's breakfast cereals: a randomized experiment.,"BACKGROUND


Cartoon characters on processed food packaging increase the perception of product preference among children, but their effect among adults has rarely been examined. We evaluated the effect of a cartoon character on breakfast cereals on beliefs about buying them for children, as well as whether demographic characteristics modified this effect.
METHODS


An experimental study was conducted with adults from online consumer panels in Mexico (n = 3755). Participants were randomly assigned to a ""cartoon"" condition (n = 1789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition (n = 1966), in which the same cereal box was displayed with no character on the package. Participants were asked: ""Is this a good cereal to buy children?"" with the response options ""Yes"", ""No"", or ""Don't know"". Multinomial adjusted logistic models regressed responses to this question (Yes = 0, No = 1, 2 = Don't know) on experimental condition. Differences in the effect of the cartoon character across demographic characteristics were tested by introducing multiplicative interaction terms.
RESULTS


The adjusted model showed that participants in the ""cartoon character"" condition were 1.67 (1.45-1.94) times more likely to consider the cereal as being ""Not good to buy for children"" than those in the control condition (p < 0.001). This effect was smaller among parents (RRR = 1.39, 1.13-1.72) compared to those without children (RRR = 2.01, 1.63-2.47). No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
CONCLUSION


Among this sample of Mexican adults, a cereal with a cartoon character on the packaging was more often perceived as ""not good to buy for children"" compared to a cereal without it. This effect was smaller among parents, potentially due to children influences of parental decisions during food purchasing.",2020,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[""adults perceptions of Children's breakfast cereals"", 'adults from online consumer panels in Mexico (n\u2009=\u20093755']","['cartoon"" condition (n\u2009=\u20091789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition', 'cartoon character', 'cartoon character on breakfast cereals']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0482463,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Contreras-Manzano', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Jáuregui', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico. alejandra.jauregui@insp.mx.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nieto', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vargas-Meza', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Thrasher', 'Affiliation': 'Population Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Illescas-Zárate', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Demography, ANU College of Arts and Social Sciences, The Australian National University, 9 Fellows Road Acton ACT, Canberra, 260, Australia.'}]",Nutrition journal,['10.1186/s12937-020-00565-5']
1664,25846982,Race/Ethnicity and Treatment Outcome in a Randomized Controlled Trial for Trichotillomania (Hair-Pulling Disorder).,"OBJECTIVE


Treatment outcome was compared among non-Hispanic White and racial/ethnic minority participants with trichotillomania (TTM), or hair-pulling disorder.
METHOD


Symptom severity, quality of life, and TTM-related disability were compared in a behavior therapy trial with a stepped care approach: web-based self-help and then individual behavior therapy. The sample comprised 72% (n = 38) non-Hispanic White participants and 28% (n = 15) minority participants.
RESULTS


The ethnic groups responded differently to treatment, with fewer minority participants showing improvement during web-based self-help. Response rates were equivalent between ethnic groups during the in-person behavior therapy. These results should be interpreted with caution because of the small sample size of minorities in the study and consequent inability to analyze results for each racial/ethnic group individually.
CONCLUSIONS


Future studies should focus on the investigation of factors that may enable or hinder racial and ethnic minority participants to benefit from online and/or self-help behavior therapy for TTM.",2015,Response rates were equivalent between ethnic groups during the in-person behavior therapy.,"['The sample comprised 72% (n = 38) non-Hispanic White participants and 28% (n = 15) minority participants', 'Hair-Pulling Disorder', 'non-Hispanic White and racial/ethnic minority participants with trichotillomania (TTM), or hair-pulling disorder']",['Trichotillomania'],"['Response rates', 'Symptom severity, quality of life, and TTM-related disability']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",38.0,0.0837517,Response rates were equivalent between ethnic groups during the in-person behavior therapy.,"[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Falkenstein', 'Affiliation': 'American University.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'American University.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'American University.'}, {'ForeName': 'David A F', 'Initials': 'DA', 'LastName': 'Haaga', 'Affiliation': 'American University.'}]",Journal of clinical psychology,['10.1002/jclp.22171']
1665,25794605,Immediate versus deferred initiation of androgen deprivation therapy in prostate cancer patients with PSA-only relapse. An observational follow-up study.,"BACKGROUND


The optimal timing to start androgen deprivation therapy (ADT) in prostate cancer patients with rising prostate-specific antigen (PSA) as the only sign of relapse is unknown.
METHODS


We identified men with prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavour (CaPSURE) study who would have been eligible (⩽ cT3aN0M0, primary radical prostatectomy or radiotherapy, PSA relapse as the only evidence of recurrence) for a randomised trial comparing 'immediate' versus 'deferred' ADT initiation. We emulated such trial by assigning patients to the 'immediate' strategy if they initiated ADT within 3 months of PSA relapse and to the 'deferred' strategy if they initiated ADT when they presented with metastasis, symptoms or a short PSA doubling time. We censored patients when they deviated from the assigned strategy and adjusted for this censoring via inverse probability weighting.
RESULTS


Of 2096 eligible patients (median age 69, interquartile range 63-75 years), 88% were white, 35% had a Gleason score ⩾ 7, 69% were treated with radical prostatectomy and 31% received radiotherapy only as primary treatment. The mean time from primary treatment to PSA relapse was 37.4 (standard deviation [SD] 34.2) months. Mean follow-up from primary treatment was 91.4 (SD 48.4) months. The adjusted mortality hazard ratio for immediate versus deferred ADT was 0.91 (95% confidence interval (CI), 0.52-1.60), which would be translated into a similar 5-year survival (difference between groups: -2.0% (95% CI: -10.0 to 5.9%).
CONCLUSION


Our analysis suggests that prostate cancer patients undergoing immediate ADT initiation within three months after PSA-only relapse had similar survival to those who deferred ADT initiation within 3 months after clinical progression.",2015,"The adjusted mortality hazard ratio for immediate versus deferred ADT was 0.91 (95% confidence interval (CI), 0.52-1.60), which would be translated into a similar 5-year survival (difference between groups: -2.0% (95% CI: -10.0 to 5.9%).
","['2096 eligible patients (median age 69, interquartile range 63-75 years), 88% were white, 35% had a Gleason score ⩾ 7, 69% were treated with', 'men with prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavour (CaPSURE) study who would have been eligible (⩽ cT3aN0M0, primary', 'prostate cancer patients with PSA-only relapse', 'prostate cancer patients with rising prostate-specific antigen (PSA']","['androgen deprivation therapy', 'radical prostatectomy or radiotherapy', 'start androgen deprivation therapy (ADT', 'radical prostatectomy', 'radiotherapy']","['5-year survival', 'adjusted mortality hazard ratio', 'mean time', 'PSA relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",2096.0,0.213641,"The adjusted mortality hazard ratio for immediate versus deferred ADT was 0.91 (95% confidence interval (CI), 0.52-1.60), which would be translated into a similar 5-year survival (difference between groups: -2.0% (95% CI: -10.0 to 5.9%).
","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Garcia-Albeniz', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States. Electronic address: xabi@post.harvard.edu.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Departments of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States; Department of Urology, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paciorek', 'Affiliation': 'Departments of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Logan', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Kenfield', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Departments of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States; Department of Urology, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Carroll', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Harvard-MIT Division of Health Sciences and Technology, Boston, MA, United States.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2015.03.003']
1666,32420463,RADIANCE - Radiochemotherapy with or without Durvalumab in the treatment of anal squamous cell carcinoma: A randomized multicenter phase II trial.,"Purpose


Anal squamous cell carcinomas (ASCC) are increasing in frequency across the developed world. The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT). There is a strong rationale for combining immunotherapy with RCT in patients with ASCC due to its association with human papilloma virus (HPV) infection.
Methods/design


RADIANCE is an investigator initiated, prospective, multicenter, randomized phase II trial testing the addition of Durvalumab, a PD-L1 immune checkpoint inhibitor, to standard RCT in 178 patients with locally advanced ASCC (T2 ≥ 4 cm Nany, cT3-4 and/or cN+). In the control arm, patients will be treated with standard mitomycin C (MMC)/5-fluorouracil (5-FU)-based RCT. Intensity-modulated radiotherapy (IMRT) will be applied as follows: PTV_A (primary tumor) T1-T2 < 4 cm N+: 28 × 1.9 Gy = 53.2 Gy;  or  T2 ≥ 4 cm, T3-4 Nany: 31 × 1.9 Gy = 58.9 Gy; PTV_N (involved node): 28 × 1.8 Gy = 50.4 Gy ; and PTV_Elec (elective node): 28 × 1.43 Gy = 40.0 Gy over a period of 5,5-6 weeks. Concomitant chemotherapy will be administered using MMC with 5-FU during weeks 1 and 5 of radiotherapy (MMC 12 mg/m 2 , day 1 [maximum single dose 20 mg]; 5-FU 1000 mg/m 2  days 1-4 and 29-32). In the experimental arm, Durvalmab (1500 mg absolute dose, intravenously) will be combined with the same RCT as in the control arm. Immunotherapy with Durvalumab will start 14 days before initiation of standard RCT, administered every four weeks (q4w) thereafter for a total of twelve doses. The primary endpoint is disease-free survival (DFS) after 3 years.
Discussion


As ASCC is considered an immunogenically ""hot"" tumor due to its association with HPV infection, the combination of RCT with Durvalumab may improve tumor control and long-term clinical outcome in this patient collective compared to RCT alone.",2020,The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT).,"['node', '58.9', 'anal squamous cell carcinoma', '178 patients with locally advanced ASCC (T2', 'patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT', '28\xa0×\xa01.8', 'Anal squamous cell carcinomas (ASCC', 'Nany', 'patients with ASCC', '28\xa0×\xa01.9']","['Durvalumab, a PD-L1 immune checkpoint inhibitor, to standard RCT', 'N', 'Concomitant chemotherapy', 'standard mitomycin C (MMC)/5-fluorouracil (5-FU)-based RCT', 'MMC with 5-FU', 'radiotherapy (MMC', 'Intensity-modulated radiotherapy (IMRT', 'Durvalmab', 'Radiochemotherapy with or without Durvalumab', '5-FU', 'Immunotherapy with Durvalumab']","['3-year disease-free survival (DFS', 'disease-free survival (DFS']","[{'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517517', 'cui_str': '1.9'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",178.0,0.12299,The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Balermpas', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zürich, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Gollrad', 'Affiliation': 'Department of Radiotherapy and Oncology, Charité University Hospital Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Weiß', 'Affiliation': 'Department of Radiotherapy and Oncology, Community Hospital Darmstadt, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Valentini', 'Affiliation': 'Department of Radiotherapy and Oncology, University Hospital Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stuschke', 'Affiliation': 'Department of Radiotherapy, University Hospital Essen, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Department of Radiotherapy, University Hospital Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henckenberens', 'Affiliation': 'Department of Radiotherapy, University Hospital Hannover, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiology and Radiotherapy, University Hospital Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiotherapy, University Hospital Schleswig Holstein, Kiel, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'Department of Radiotherapy, University Hospital Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunner', 'Affiliation': 'Department of Radiotherapy, University Hospital Magdeburg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Bostel', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Engenhart-Cabillic', 'Affiliation': 'Department of Radiotherapy Radiation Oncology, University Hospital Marburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Hospital Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Combs', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Belka', 'Affiliation': 'Department of Radiation Oncology, University Hospital LMU Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hautmann', 'Affiliation': 'Department of Radiotherapy,University Hospital Regensburg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy,University Hospital Rostock, Germany.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Gani', 'Affiliation': 'Department of Radiation Oncology,University Hospital Tübingen, Germany.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'Department of Radiation Oncology, University of Würzburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2020.04.010']
1667,25663723,Sex-Linked Mating Strategies Diverge with a Manipulation of Genital Salience.,"Trivers (1972) proposed that evolutionary factors should favor divergent mating strategies for males versus females. Such differences may be less pronounced among human beings than other animals and social norms and sex roles are also pertinent influences. The present experiment ( N  = 133 college undergraduates, 74 female) sought to bypass some of these other influences. Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow). They then reported on their interest in short-term (e.g., a one-night stand) and long-term (e.g., a potential marital partner) mating opportunities. A theory-consistent three-way interaction occurred such that the genital salience manipulation primed a shorter-term reproductive strategy among men and a longer-term reproductive strategy among women. The results provide unique support for evolution-linked ideas about sex differences in the form of a role for bodily attention.",2015,Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow).,"['133 college undergraduates, 74 female']",['condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow'],[],"[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0446509', 'cui_str': 'Genital region (body structure)'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0336721', 'cui_str': 'Arrow, device (physical object)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}]",[],,0.0166517,Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow).,"[{'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Fetterman', 'Affiliation': 'Knowledge Media Research Center.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Kruger', 'Affiliation': 'North Dakota State University.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Robinson', 'Affiliation': 'North Dakota State University.'}]",Motivation and emotion,[]
1668,24982504,"Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT.","Grades 2-4 acute graft-versus-host disease (GVHD) occurs in approximately 35% of matched, related donor (MRD) allogeneic hematopoietic cell transplantation (HCT) recipients. We sought to determine if the combination of tacrolimus and sirolimus (Tac/Sir) was more effective than tacrolimus and methotrexate (Tac/Mtx) in preventing acute GVHD and early mortality after allogeneic MRD HCT in a phase 3, multicenter trial. The primary end point of the trial was to compare 114-day grades 2-4 acute GVHD-free survival using an intention-to-treat analysis of 304 randomized subjects. There was no difference in the probability of day 114 grades 2-4 acute GVHD-free survival (67% vs 62%, P = .38). Grades 2-4 GVHD was similar in the Tac/Sir and Tac/Mtx arms (26% vs 34%, P = .48). Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm (14 vs 16 days, P < .001; 16 vs 19 days, P = .03). Oropharyngeal mucositis was less severe in the Tac/Sir arm (peak Oral Mucositis Assessment Scale score 0.70 vs 0.96, P < .001), but otherwise toxicity was similar. Chronic GVHD, relapse-free survival, and overall survival at 2 years were no different between study arms (53% vs 45%, P = .06; 53% vs 54%, P = .77; and 59% vs 63%, P = .36). Based on similar long-term outcomes, more rapid engraftment, and less oropharyngeal mucositis, the combination of Tac/Sir is an acceptable alternative to Tac/Mtx after MRD HCT. This study was funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute; and the trial was registered at www.clinicaltrials.gov as #NCT00406393.",2014,"Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm (14 vs 16 days, P < .001; 16 vs 19 days, P = .03).",[],"['tacrolimus and methotrexate (Tac/Mtx', 'Tacrolimus/sirolimus vs tacrolimus/methotrexate', 'tacrolimus and sirolimus (Tac/Sir']","['Grades 2-4 GVHD', 'otherwise toxicity', 'Neutrophil and platelet engraftment', 'probability of day 114 grades 2-4 acute GVHD-free survival', 'Oropharyngeal mucositis', '114-day grades 2-4 acute GVHD-free survival', 'Chronic GVHD, relapse-free survival, and overall survival', 'rapid engraftment, and less oropharyngeal mucositis, the combination of Tac']",[],"[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]",304.0,0.14658,"Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm (14 vs 16 days, P < .001; 16 vs 19 days, P = .03).","[{'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Cutler', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Logan', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'City of Hope Medical Center, Duarte, CA;'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Stanford University, Stanford, CA;'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'University of Michigan, Ann Arbor, MI;'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Porter', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA;'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hogan', 'Affiliation': 'Mayo Clinic, Rochester, MN;'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pasquini', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'MacMillan', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN;'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Hsu', 'Affiliation': 'University of Florida, Gainesville, FL;'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA;'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Grupp', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, PA;""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCarthy', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY; and.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Zhen-Huan', 'Initials': 'ZH', 'LastName': 'Hu', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Carter', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;'}]",Blood,['10.1182/blood-2014-04-567164']
1669,31542446,Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus.,"BACKGROUND


The importance of providing accurate medication information that can be easily comprehended by patients to subsequently best use their medication(s) has been widely reported in the literature. Patient information leaflet (PIL) is a supporting tool aiding patients to make decisions about their treatment plan and improve patient-clinician communication and thus medication adherence. PIL is the written document produced by the pharmaceutical manufacturers and packed with the medicine. The available PILs do not consider cultural and behavioral perspectives of diverse populations residing in a country like Qatar. Consumer medication information (CMI) is written information about prescription drugs developed by organizations or individuals other than a drug's manufacturer that is intended for distribution to consumers at the time of drug dispensing.
OBJECTIVE


To investigate the impact of customized CMI (C-CMI) on health-related quality of life (HRQoL) among type 2 diabetes mellitus (T2DM) patients in Qatar.
METHODS


This was a randomized controlled intervention study, in which the intervention group patients received C-CMI and the control group patients received usual care. HRQoL was measured using the EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS) at three intervals [i.e. baseline, after 3 months and 6 months].
RESULTS


The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit. There was a statistically significant difference between groups in the HRQoL utility value (represented as EQ index) at 6 months (0.939 vs. 0.796; p = 0.019). Similarly, the intervention group compared with the control group had significantly greater EQ-VAS at 6 months (90% vs. 80%; p = 0.003).
CONCLUSIONS


The impact of C-CMI on health outcomes of T2DM patients in Qatar reported improvement in HRQoL indicators among the intervention patients. The study built a platform for health policymakers and regulatory agencies to consider the provision of C-CMI in multiple languages.",2020,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus (T2DM) patients in Qatar']","['customized CMI (C-CMI', 'C-CMI and the control group patients received usual care', 'customized-consumer medication information']","['EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS', 'HRQoL', 'health-related quality of life (HRQoL', 'HRQoL indicators', 'health-related quality of life', 'EQ-5D-5L index value', 'HRQoL utility value', 'EQ-VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0034366', 'cui_str': 'State of Qatar'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0412891,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"[{'ForeName': 'Emad Eldin', 'Initials': 'EE', 'LastName': 'Munsour', 'Affiliation': 'Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar. Electronic address: emadkirra@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awaisu', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Mohamed Azmi', 'Initials': 'MA', 'LastName': 'Ahmad Hassali', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Doha, Qatar.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dabbous', 'Affiliation': 'Diabetes/Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noran', 'Initials': 'N', 'LastName': 'Zahran', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Abdoun', 'Affiliation': 'National Diabetes Center, Hamad Medical Corporation, Doha, Qatar.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.08.038']
1670,25117129,Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.,"IMPORTANCE


Colorectal cancer is a major health burden. Screening is recommended in many countries.
OBJECTIVE


To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial.
DESIGN, SETTING, AND PARTICIPANTS


Randomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry.
INTERVENTIONS


Participants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention.
MAIN OUTCOMES AND MEASURES


Colorectal cancer incidence and mortality.
RESULTS


A total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups.
CONCLUSIONS AND RELEVANCE


In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00119912.",2014,"In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening.","['Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy', 'Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011', '100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway', '98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a', 'Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry']","['flexible sigmoidoscopy screening', 'no intervention', 'receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT', 'flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT']","['Colorectal cancer', 'Colorectal cancer incidence and mortality', 'Colorectal cancer incidence', 'died of colorectal cancer', 'colorectal cancer incidence and mortality']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1723187', 'cui_str': '3-(4-dimethylaminophenyl)-N-hydroxy-2-propenamide'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0013975', 'cui_str': 'Emigration'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",100210.0,0.370472,"In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening.","[{'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Holme', 'Affiliation': 'Department of Medicine, Sorlandet Hospital Kristiansand, Kristiansand, Norway2Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics Harvard School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Telemark Hospital Skien, Skien, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Department of Medicine, Sorlandet Hospital Kristiansand, Kristiansand, Norway2Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tor J', 'Initials': 'TJ', 'LastName': 'Eide', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'School of Pharmacy, University of Oslo, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Schneede', 'Affiliation': 'Department of Pharmacology and Clinical Neuroscience, Clinical Pharmacology Unit, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Kjell Magne', 'Initials': 'KM', 'LastName': 'Tveit', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hoff', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway7Telemark Hospital Skien, Skien, Norway13Cancer Registry of Norway, Oslo, Norway.'}]",JAMA,['10.1001/jama.2014.8266']
1671,25365567,Competitive interaction leads to perceptual distancing between actors.,"People physically distance themselves from competitors and the disliked, and cooperate less with those who are further away. We examine whether social interaction can also impact the space people perceive between themselves and others by measuring the influence of competitive dynamics on visual perception. In 2 experiments, participants played a ball toss game until they reached a target score. In Experiment 1, a confederate stood across the room from the participant and either (a) played the same game competitively, (b) played the same game cooperatively, or (c) observed the participant without playing, while in Experiment 2, 2 participants played the same versions of the game with each other. After the game, participants provided an estimate of the distance between themselves and the other player. Participants in Experiment 1 who competed with the confederate consistently judged her to be more distant than participants who cooperated with the confederate or played alone. In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing. These findings demonstrate the power of a socially distancing interaction to create perceptual distance between people.",2014,"In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing.",['Participants in Experiment 1 who competed with the confederate consistently judged her to be more distant than participants who cooperated with the confederate or played alone'],[],[],"[{'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],[],2.0,0.0174547,"In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Davoli', 'Affiliation': 'Department of Psychology, Central Michigan University.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Brockmole', 'Affiliation': 'Department of Psychology, University of Notre Dame.'}]",Journal of experimental psychology. Human perception and performance,['10.1037/a0038307']
1672,25170121,Phase 3 clinical trial of steroids/mycophenolate mofetil vs steroids/placebo as therapy for acute GVHD: BMT CTN 0802.,"Corticosteroids are the accepted primary therapy for acute graft-versus-host disease (GVHD), but durable responses are seen in only about half of the patients. Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0802, a phase 3 multicenter randomized double-blinded trial, was designed to test whether mycophenolate mofetil (MMF) plus corticosteroids was superior to corticosteroids alone as initial therapy for acute GVHD. Patients with newly diagnosed acute GVHD were eligible if they required systemic therapy. Patients were randomized to receive prednisone with either MMF or placebo. The primary end point was acute or chronic GVHD-free survival at day 56 after initiation of therapy. A futility rule for GVHD-free survival at day 56 was met at a planned interim analysis after 235 patients (of 372) were enrolled: 116 MMF, 119 placebo. Baseline characteristics were well balanced between treatment groups including grade and organ distribution of GVHD. GVHD-free survival at day 56, cumulative incidence of chronic GVHD at 12 months, overall survival, Epstein-Barr virus reactivation, severe, life-threatening infections, relapse at 12 months, and quality of life were similar. The addition of MMF to corticosteroids as initial therapy for acute GVHD does not improve GVHD-free survival compared with corticosteroids alone. This trial was registered at www.clinicaltrials.gov as #NCT01002742.",2014,The addition of MMF to corticosteroids as initial therapy for acute GVHD does not improve GVHD-free survival compared with corticosteroids alone.,"['acute GVHD', 'Patients with newly diagnosed acute GVHD were eligible if they required systemic therapy', '235 patients (of 372) were enrolled: 116 MMF, 119']","['placebo', 'prednisone', 'mycophenolate mofetil (MMF) plus corticosteroids', 'steroids/mycophenolate mofetil vs steroids/placebo', 'MMF or placebo', 'Corticosteroids']","['acute or chronic GVHD-free survival', 'overall survival', ' Epstein-Barr virus reactivation, severe, life-threatening infections, relapse at 12 months, and quality of life', 'cumulative incidence of chronic GVHD', 'GVHD-free survival']","[{'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",372.0,0.601535,The addition of MMF to corticosteroids as initial therapy for acute GVHD does not improve GVHD-free survival compared with corticosteroids alone.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': 'Bone Marrow Transplant Program, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, MD;'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Department of Stem Cell Transplant and Cellular Therapies, MD Anderson Cancer Center, Houston, TX;'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Dana-Farber Cancer Institute, Department of Medical Oncology, Boston, MA;'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barowski', 'Affiliation': 'The Emmes Corporation, Rockville, MD;'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Carter', 'Affiliation': 'The Emmes Corporation, Rockville, MD;'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Goldstein', 'Affiliation': 'Blood and Marrow Transplant Program, University of Michigan, Ann Arbor, MI;'}, {'ForeName': 'Elizabeth O', 'Initials': 'EO', 'LastName': 'Hexner', 'Affiliation': 'Department of Medicine, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA;'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Department Medicine, University of Washington School of Medicine, Seattle, WA;'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': 'Blood and Marrow Transplant Program, University of Michigan, Ann Arbor, MI;'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'MacMillan', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Pediatrics, University of Minnesota, Minneapolis, MN;'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Department Medicine, University of Washington School of Medicine, Seattle, WA;'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Mendizabal', 'Affiliation': 'The Emmes Corporation, Rockville, MD;'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota, Minneapolis, MN; and.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Westervelt', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Vincent T', 'Initials': 'VT', 'LastName': 'Ho', 'Affiliation': 'Dana-Farber Cancer Institute, Department of Medical Oncology, Boston, MA;'}]",Blood,['10.1182/blood-2014-06-577023']
1673,31543407,Fast versus gradual adaptation of soft daily disposable contact lenses in neophyte wearers.,"PURPOSE


Despite the widespread practice of gradually adapting all new soft contact lens wearers (neophytes), there is little evidence-based research underpinning such practice. This work determined if a gradual adaptation period is necessary for neophytes when fitted with modern hydrogel or silicone-hydrogel daily disposable contact lenses.
METHOD


At four sites, neophytes (19-32 years) were randomly assigned to an adaptation schedule: fast (10 h wear from the first day) or gradual (4 h on the first day, increasing their wear-time by 2 h on each subsequent day until they had reached 10 h) with hydrogel (n = 24 fast; n = 21 gradual) or silicone-hydrogel (n = 10 fast; n = 10 gradual) contact lenses. Masked investigators graded ocular surface physiology and non-invasive tear breakup time (NIBUT). A range of subjective scores (using 0-100 visual analogue scales) were recorded at the initial visit and after 10 h of lens wear, 4-6 days and 12-14 days after initial fitting. Subjective scores were also repeated after 7 days.
RESULTS


There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type. NIBUT was similar at all time points for both adaptation groups in both lens types with the exception that the gradual adaptation silicone-hydrogel wearers had a slightly longer NIBUT (p = 0.007) than the fast adaptation group at 12-14 days. Subjective scores were also similar across the visits and lens types with the exception of 'lens awareness' and 'ease of lens removal' which were better (p < 0.05) in the fast compared with the gradual adaptation hydrogel lens group at day 7. Additionally, 'end-of-day discomfort' was better (p = 0.02) in the fast compared with the gradual adaptation hydrogel lens group at 12-14 days.
CONCLUSION


There appears to be no benefit in daily disposable soft contact lens adaptation for neophytes with modern contact lens materials.",2020,There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type.,"['soft contact lens wearers (neophytes', 'neophyte wearers', 'At four sites, neophytes (19-32 years']","['hydrogel (n\u202f=\u202f24 fast; n\u202f=\u202f21 gradual) or silicone-hydrogel (n\u202f=\u202f10 fast; n\u202f=\u202f10 gradual) contact lenses', 'Fast versus gradual adaptation of soft daily disposable contact lenses']","['Subjective scores', 'ocular surface physiology', ""lens awareness' and 'ease of lens removal""]","[{'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",100.0,0.0218066,There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type.,"[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: j.s.w.wolffsohn@aston.ac.uk.'}, {'ForeName': 'Harshali', 'Initials': 'H', 'LastName': 'Dhirajlal', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: dhirajlh@aston.ac.uk.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vianya-Estopa', 'Affiliation': 'Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK. Electronic address: marta.vianya@anglia.ac.uk.'}, {'ForeName': 'Manbir', 'Initials': 'M', 'LastName': 'Nagra', 'Affiliation': 'School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, UK. Electronic address: manbir.nagra@port.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Madden', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: Louise.madedn@nes.scot.nhs.uk.'}, {'ForeName': 'Laura Elaine', 'Initials': 'LE', 'LastName': 'Sweeney', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: laura.sweeney@gcu.ac.uk.'}, {'ForeName': 'Anna Sarah', 'Initials': 'AS', 'LastName': 'Goodyear', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: agoody200@caledonian.ac.uk.'}, {'ForeName': 'Lauren Victoria', 'Initials': 'LV', 'LastName': 'Kerr', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: lkerr209@caledonian.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Terry', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, CF24 4HQ, UK. Electronic address: terryl1@cardiff.ac.uk.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, CF24 4HQ, UK. Electronic address: sheikhsz@cardiff.ac.uk.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Murphy', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: orla.murphy@dit.ie.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Lloyd', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: aoife.lloydmckernan@dit.ie.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Maldonado-Codina', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: carole.m-codina@manchester.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.08.011']
1674,31339008,"Premeal Consumption of a Protein-Enriched, Dietary Fiber-Fortified Bar Decreases Total Energy Intake in Healthy Individuals.","BACKGROUND


A premeal load of protein can increase satiety and reduce energy intake. Dietary fiber also conveys metabolic benefits by modulating energy intake. We made a protein-enriched, dietary fiber-fortified bar (PFB) and aimed to investigate its effects on food intake and gut hormone secretion in healthy individuals.
METHODS


Twenty subjects with normal glucose tolerance were enrolled. On three separate visits, the subjects received, in a randomized order, one of the following: a PFB containing 73 kcal with 10.7 g of protein and 12.7 g of dietary fiber; a usual bar (UB) containing the same calories as the PFB but only 0.9 g of protein and no dietary fiber; or water (control). After 15 minutes, the subjects had  ad libitum  intake of a test meal. Food consumption, appetite, and plasma gut hormone levels were measured.
RESULTS


Total energy intake, including the bar and the test meal, was significantly reduced with the PFB preload compared to the water (904.4±534.9 kcal vs. 1,075.0±508.0 kcal,  P =0.016). With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water. Fullness was also significantly increased after the PFB. In addition, postprandial glucose levels decreased and glucagon-like peptide-1 levels increased with the PFB compared with both the UB and water.
CONCLUSION


In healthy individuals, a premeal supplementation of PFB reduced total energy intake and decreased postprandial glucose excursion. This finding necessitates long-term studies regarding clinical use in obesity.",2019,"With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water.","['healthy individuals', 'Healthy Individuals', 'Twenty subjects with normal glucose tolerance were enrolled']","['Premeal Consumption of a Protein-Enriched, Dietary Fiber-Fortified Bar', 'protein-enriched, dietary fiber-fortified bar (PFB', 'PFB containing 73 kcal with 10.7 g of protein and 12.7 g of dietary fiber; a usual bar (UB) containing the same calories as the PFB but only 0.9 g of protein and no dietary fiber; or water (control']","['PFB preload', 'Fullness', 'postprandial glucose levels decreased and glucagon-like peptide-1 levels', 'Total energy intake', 'total energy intake', 'total energy intake and decreased postprandial glucose excursion', 'Food consumption, appetite, and plasma gut hormone levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",20.0,0.0174969,"With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water.","[{'ForeName': 'Chang Ho', 'Initials': 'CH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. ymchomd@snu.ac.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2018.0202']
1675,30230349,Reply to Fitzmaurice  et al. : The LIBERATE Trial: Options to Reduce the Risk of Post-procedural Pneumothorax and Length of Stay.,,2018,,[],[],[],[],[],[],,0.0308043,,"[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple UniversityPhiladelphia, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sue', 'Affiliation': ""St. Joseph's Hospital and Medical CenterPhoenix, Arizona.""}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': 'University of PittsburghPittsburgh, Pennsylvaniaand.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'University Medical Center GroningenGroningen, the Netherlands.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201808-1477LE']
1676,30877042,Editorial: Identifying Predictors of Treatment Response Trajectories of Suicidal Adolescents.,"In this issue of the Journal, Abbott et al. 1  present findings from an important secondary analysis of a randomized controlled trial that identifies predictors of treatment response. Previous research has highlighted the importance of varying trajectories of treatment response. 2,3  There is a need to identify factors related to varied treatment outcomes. Determining those who will benefit from treatment compared to those who will not is an important step to personalizing treatments.",2019,Determining those who will benefit from treatment compared to those who will not is an important step to personalizing treatments.,"['1,2', 'Suicidal Adolescents']",[],[],"[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.0301499,Determining those who will benefit from treatment compared to those who will not is an important step to personalizing treatments.,"[{'ForeName': 'Betsy Dohoney', 'Initials': 'BD', 'LastName': 'Kennard', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas. Electronic address: beth.kennard@utsouthwestern.edu.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Zullo', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.03.012']
1677,24982459,Improved survival after transplantation of more donor plasmacytoid dendritic or naïve T cells from unrelated-donor marrow grafts: results from BMTCTN 0201.,"PURPOSE


To characterize relationships between specific immune cell subsets in bone marrow (BM) or granulocyte colony-stimulating factor-mobilized peripheral blood (PB) stem cells collected from unrelated donors and clinical outcomes of patients undergoing transplantation in BMTCTN 0201.
PATIENTS AND METHODS


Fresh aliquots of 161 BM and 147 PB stem-cell allografts from North American donors randomly assigned to donate BM or PB stem cells and numbers of transplanted cells were correlated with overall survival (OS), relapse, and graft-versus-host disease (GvHD).
RESULTS


Patients with evaluable grafts were similar to all BMTCTN 0201 patients. The numbers of plasmacytoid dendritic cells (pDCs) and naïve T cells (Tns) in BM allografts were independently associated with OS in multivariable analyses including recipient and donor characteristics, such as human leukocyte antigen mismatch, age, and use of antithymocyte globulin. BM recipients of > median number of pDCs, naïve CD8(+) T cells (CD8Tns), or naïve CD4(+) T cells (CD4Tns) had better 3-year OS (pDCs, 56% v 35%; P = .025; CD8Tns, 56% v 37%; P = .012; CD4Tns, 55% v 37%; P = .009). Transplantation of more BM Tns was associated with less grade 3 to 4 acute GvHD but similar rates of relapse. Transplantation of more BM pDCs was associated with fewer deaths resulting from GvHD or from graft rejection. Analysis of PB grafts did not identify a donor cell subset significantly associated with OS, relapse, or GvHD.
CONCLUSION


Donor immune cells in BM but not PB stem-cell grafts were associated with survival after unrelated-donor allogeneic hematopoietic stem-cell transplantation. The biologic activity of donor immune cells in allogeneic transplantation varied between graft sources. Donor grafts with more BM-derived Tns and pDCs favorably regulated post-transplantation immunity in allogeneic hematopoietic stem-cell transplantation.",2014,"T cells (CD4Tns) had better 3-year OS (pDCs, 56% v 35%; P = .025; CD8Tns, 56% v 37%; P = .012; CD4Tns, 55% v 37%; P = .009).","['Fresh aliquots of 161 BM and 147 PB stem-cell allografts from North American donors', 'patients undergoing transplantation in BMTCTN 0201', 'allogeneic hematopoietic stem-cell transplantation']",['bone marrow (BM) or granulocyte colony-stimulating factor-mobilized peripheral blood (PB) stem cells'],"['OS, relapse, or GvHD', 'numbers of plasmacytoid dendritic cells (pDCs) and naïve T cells (Tns) in BM allografts', 'survival', 'Improved survival', 'pDCs, naïve CD8(+) T cells (CD8Tns), or naïve CD4', 'overall survival (OS), relapse, and graft-versus-host disease (GvHD']","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1956385', 'cui_str': 'Plasmacytoid Dendritic Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",201.0,0.0750796,"T cells (CD4Tns) had better 3-year OS (pDCs, 56% v 35%; P = .025; CD8Tns, 56% v 37%; P = .012; CD4Tns, 55% v 37%; P = .009).","[{'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. ewaller@emory.edu.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Wayne A C', 'Initials': 'WA', 'LastName': 'Harris', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Mineishi', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'McCarty', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Gonzalez', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Spitzer', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Oleg I', 'Initials': 'OI', 'LastName': 'Krijanovski', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Linenberger', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Woolfrey', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Confer', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'Edmund K. Waller and Wayne A.C. Harris, Emory University, Atlanta, GA; Brent R. Logan, Medical College of Wisconsin, Milwaukee, WI; Steven M. Devine, Ohio State University, Columbus, OH; David L. Porter, University of Pennsylvania, Philadelphia, PA; Shin Mineishi, University of Alabama at Birmingham, Birmingham, AL; John M. McCarty, Medical College of Virginia, Richmond, VA; Corina E. Gonzalez, Georgetown University Hospital, Washington, DC; Thomas R. Spitzer, Massachusetts General Hospital, Boston, MA; Oleg I. Krijanovski, Sutter East Bay Medical Foundation, Berkeley, CA; Michael L. Linenberger and Ann Woolfrey, Fred Hutchinson Cancer Research Center, Seattle, WA; Alan Howard and Dennis L. Confer, National Marrow Donor Program, Minneapolis, MN; Juan Wu, EMMES Corporation, Rockville, MD; and Claudio Anasetti, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2013.54.4577']
1678,31542816,Flexible reamers create comparable anterior cruciate ligament reconstruction femoral tunnels without the hyperflexion required with rigid reamers: 3D-CT analysis of tunnel morphology in a randomised clinical trial.,"PURPOSE


The hyperflexion required for femoral tunnel drilling in anterior cruciate ligament reconstruction can be challenging in patients with increased body habitus or musculature. Whilst allowing femoral tunnel creation without hyperflexion, additional benefits of flexible reamers have been proposed in terms of tunnel dimensions. The purpose of this study was to examine whether these theoretical benefits are seen in a clinical study.
METHODS


Fifty adult patients (with isolated anterior cruciate ligament rupture) were randomised to reconstruction with either flexible or rigid femoral reamers. Femoral tunnel drilling was performed at 100° flexion (flexible system) or maximal hyperflexion (rigid system). Otherwise, the procedure was standardised. Femoral tunnel measurements were performed by a consultant musculoskeletal radiologist who was blinded to the method of femoral drilling. Tunnel position, length and angles (axial and coronal) were measured alongside aperture shape and exit point using three-dimensional computed tomography 3-6 months post-operatively.
RESULTS


With no difference in tunnel position, tunnel length was found to increase with the use of the flexible system (37.8 ± 3.7 vs 35.0 ± 4.4 mm; p = 0.024). In addition, the exit point and fixation device were more anterior on the lateral femur using the flexible reamers (p = 0.016). No difference was seen in either tunnel angles or aperture shape. One case of incomplete posterior blow-out was seen in each of the study groups.
CONCLUSIONS


This comparative study shows that flexible reamers can reproduce a desired femoral tunnel position with only small improvements of no clinical relevance. As this can be achieved without hyperflexing the knee, these systems can be used for all patients (even when hyperflexion is a challenge).
LEVEL OF EVIDENCE


I.",2020,This comparative study shows that flexible reamers can reproduce a desired femoral tunnel position with only small improvements of no clinical relevance.,"['patients with increased body habitus or musculature', 'anterior cruciate ligament reconstruction femoral tunnels without the hyperflexion required with rigid reamers', 'Fifty adult patients (with isolated anterior cruciate ligament rupture']","['Femoral tunnel drilling was performed at 100° flexion (flexible system) or maximal hyperflexion (rigid system', 'reconstruction with either flexible or rigid femoral reamers']","['exit point and fixation device', 'tunnel position, tunnel length', 'tunnel angles or aperture shape', 'Tunnel position, length and angles (axial and coronal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0231454', 'cui_str': 'Increased flexion (finding)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0491916', 'cui_str': 'Reamer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0231454', 'cui_str': 'Increased flexion (finding)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0491916', 'cui_str': 'Reamer'}]","[{'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0441254', 'cui_str': 'Fixator (physical object)'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}]",50.0,0.0198786,This comparative study shows that flexible reamers can reproduce a desired femoral tunnel position with only small improvements of no clinical relevance.,"[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kosy', 'Affiliation': 'Exeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, Devon, UK. Jonkosy@yahoo.co.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Walmsley', 'Affiliation': 'Exeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, Devon, UK.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Anaspure', 'Affiliation': 'Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schranz', 'Affiliation': 'Exeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, Devon, UK.'}, {'ForeName': 'Vipul I', 'Initials': 'VI', 'LastName': 'Mandalia', 'Affiliation': 'Exeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, Devon, UK.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05709-7']
1679,23075175,Peripheral-blood stem cells versus bone marrow from unrelated donors.,"BACKGROUND


Randomized trials have shown that the transplantation of filgrastim-mobilized peripheral-blood stem cells from HLA-identical siblings accelerates engraftment but increases the risks of acute and chronic graft-versus-host disease (GVHD), as compared with the transplantation of bone marrow. Some studies have also shown that peripheral-blood stem cells are associated with a decreased rate of relapse and improved survival among recipients with high-risk leukemia.
METHODS


We conducted a phase 3, multicenter, randomized trial of transplantation of peripheral-blood stem cells versus bone marrow from unrelated donors to compare 2-year survival probabilities with the use of an intention-to-treat analysis. Between March 2004 and September 2009, we enrolled 551 patients at 48 centers. Patients were randomly assigned in a 1:1 ratio to peripheral-blood stem-cell or bone marrow transplantation, stratified according to transplantation center and disease risk. The median follow-up of surviving patients was 36 months (interquartile range, 30 to 37).
RESULTS


The overall survival rate at 2 years in the peripheral-blood group was 51% (95% confidence interval [CI], 45 to 57), as compared with 46% (95% CI, 40 to 52) in the bone marrow group (P=0.29), with an absolute difference of 5 percentage points (95% CI, -3 to 14). The overall incidence of graft failure in the peripheral-blood group was 3% (95% CI, 1 to 5), versus 9% (95% CI, 6 to 13) in the bone marrow group (P=0.002). The incidence of chronic GVHD at 2 years in the peripheral-blood group was 53% (95% CI, 45 to 61), as compared with 41% (95% CI, 34 to 48) in the bone marrow group (P=0.01). There were no significant between-group differences in the incidence of acute GVHD or relapse.
CONCLUSIONS


We did not detect significant survival differences between peripheral-blood stem-cell and bone marrow transplantation from unrelated donors. Exploratory analyses of secondary end points indicated that peripheral-blood stem cells may reduce the risk of graft failure, whereas bone marrow may reduce the risk of chronic GVHD. (Funded by the National Heart, Lung, and Blood Institute-National Cancer Institute and others; ClinicalTrials.gov number, NCT00075816.).",2012,"The overall incidence of graft failure in the peripheral-blood group was 3% (95% CI, 1 to 5), versus 9% (95% CI, 6 to 13) in the bone marrow group (P=0.002).","['recipients with high-risk leukemia', 'Between March 2004 and September 2009, we enrolled 551 patients at 48 centers']","['peripheral-blood stem-cell or bone marrow transplantation', 'peripheral-blood stem cells versus bone marrow']","['overall incidence of graft failure', 'overall survival rate', 'rate of relapse and improved survival', 'risk of graft failure', '2-year survival probabilities', 'incidence of acute GVHD or relapse', 'incidence of chronic GVHD']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",551.0,0.266509,"The overall incidence of graft failure in the peripheral-blood group was 3% (95% CI, 1 to 5), versus 9% (95% CI, 6 to 13) in the bone marrow group (P=0.002).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. claudio.anasetti@moffitt.org.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': ''}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': ''}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Westervelt', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Woolfrey', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Couban', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Pulsipher', 'Affiliation': ''}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Mineishi', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'McCarty', 'Affiliation': ''}, {'ForeName': 'Shakila P', 'Initials': 'SP', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Anderlini', 'Affiliation': ''}, {'ForeName': 'William I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Leitman', 'Affiliation': ''}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rowley', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bredeson', 'Affiliation': ''}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Confer', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1203517']
1680,24862638,Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies.,"Two parallel phase II trials in adults with hematologic malignancies demonstrated comparable survival after reduced-intensity conditioning and transplantation of either 2 HLA-mismatched umbilical cord blood (UCB) units or bone marrow from HLA-haploidentical relatives. Donor choice is often subject to physician practice and institutional preference. Despite clear preliminary evidence of equipoise between HLA-haploidentical related donor and double unrelated donor UCB transplantation, the actual prospect of being randomized between these 2 very different donor sources is daunting to patients and their treating physicians alike. Under these circumstances, it is challenging to conduct a phase III randomized trial in which patients are assigned to the UCB or haploidentical bone marrow arms. Therefore, we aimed to provide an evidence-based review and recommendations for selecting donors for adults without an HLA-matched sibling or an HLA-matched adult unrelated donor.",2014,"Despite clear preliminary evidence of equipoise between HLA-haploidentical related donor and double unrelated donor UCB transplantation, the actual prospect of being randomized between these 2 very different donor sources is daunting to patients and their treating physicians alike.","['adults with hematologic malignancies', 'adults without an HLA-matched sibling or an HLA-matched adult unrelated donor']","['allogeneic hematopoietic cell transplantation', 'HLA-mismatched umbilical cord blood (UCB) units or bone marrow from HLA-haploidentical relatives']",['survival'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}]","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0510744,"Despite clear preliminary evidence of equipoise between HLA-haploidentical related donor and double unrelated donor UCB transplantation, the actual prospect of being randomized between these 2 very different donor sources is daunting to patients and their treating physicians alike.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Eapen', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: meapen@mcw.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Donnell"", 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Brunstein', 'Affiliation': 'Blood and Marrow Transplant Program, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barowski', 'Affiliation': 'EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Mendizabal', 'Affiliation': 'EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Ephraim J', 'Initials': 'EJ', 'LastName': 'Fuchs', 'Affiliation': 'Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, Maryland.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2014.05.015']
1681,31843072,Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial.,"OBJECTIVE


To study whether endometrial scratching in the luteal phase before ovarian stimulation increases clinical pregnancy rates in women with one or more previous implantation failures.
DESIGN


A nonblinded multicenter randomized clinical trial.
SETTING


Fertility clinics.
PATIENT(S)


Three hundred four eligible patients scheduled for IVF/intracytoplasmic sperm injection were randomized. The intervention group (n = 151) underwent endometrial scratching in the luteal phase before controlled ovarian stimulation, while no intervention was performed in the control group (n = 153).
INTERVENTION(S)


Endometrial scratching with a Pipelle de Cornier catheter in the luteal phase before ovarian stimulation.
MAIN OUTCOME MEASURE(S)


Clinical pregnancy rate and prenatal and birth data.
RESULT(S)


There was no overall significant improvement in clinical pregnancy rates between the control and intervention groups (38.5% vs. 44.4%; relative risk = 1.15; confidence interval [0.86-1.55]). However, subgroup analyses revealed that women with three or more previous implantation failures had a significant increase in clinical pregnancy rate (31.1% vs. 53.6%; relative risk = 1.72; confidence interval [1.05-2.83]) after scratching. No difference was seen as regards prenatal and birth data between the two groups.
CONCLUSION(S)


Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures. This result seems to corroborate previous reports, which found that particularly women with repeated implantation failure seem to gain a positive effect from endometrial scratching. Importantly, there were no significant differences in prenatal data and birth data between the groups.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01963819.",2019,Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures.,"['Three hundred four eligible patients scheduled for IVF/intracytoplasmic sperm injection', 'women with one or more previous implantation failures', 'Fertility clinics', 'vitro fertilization']","['Therapeutic endometrial scratching and implantation', 'Endometrial scratching with a Pipelle de Cornier catheter', 'endometrial scratching in the luteal phase before controlled ovarian stimulation, while no intervention']","['clinical pregnancy rates', 'clinical pregnancy rate', 'regards prenatal and birth data', 'Clinical pregnancy rate and prenatal and birth data', 'prenatal data and birth data']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441192', 'cui_str': 'Pipelle (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",304.0,0.380607,Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures.,"[{'ForeName': 'Mia Steengaard', 'Initials': 'MS', 'LastName': 'Olesen', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark. Electronic address: miasolesen@gmail.com.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Hauge', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Ohrt', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Tine Nørregaard', 'Initials': 'TN', 'LastName': 'Olesen', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Roskær', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Bæk', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Helle Olesen', 'Initials': 'HO', 'LastName': 'Elbæk', 'Affiliation': 'Fertility Clinic, Skive Regional Hospital, Skive.'}, {'ForeName': 'Bugge', 'Initials': 'B', 'LastName': 'Nøhr', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynecology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Nyegaard', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael Toft', 'Initials': 'MT', 'LastName': 'Overgaard', 'Affiliation': 'Department of Chemistry and Bioscience, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Fertility Clinic, Skive Regional Hospital, Skive.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Agerholm', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.08.010']
1682,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND


Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear.
METHOD


In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs).
RESULTS


Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months.
LIMITATIONS


Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs.
CONCLUSIONS


ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035']
1683,23247045,Lymphocyte phenotype during therapy for acute graft-versus-host disease: a brief report from BMT-CTN 0302.,"Although significant strides have been made in understanding the biology of graft-versus-host disease (GVHD) and its prevention over the last 4 decades, little is known about the different populations of lymphocytes and the changes in response to treatment for this condition. BMT-CTN 0302 was a randomized phase II clinical trial in the Blood and Marrow Transplant Clinical Trials Network that assessed the efficacy of combination therapy with steroids plus pentostatin, mycophenolate mofetil, etanercept, or denileukin diftitox in patients with acute GVHD. Patients enrolled in the study underwent blood analysis by flow cytometry on days 0, 14, and 28 of therapy to enumerate the number of total lymphocytes, T cells, B cells, and lymphocytes expressing activation markers. Baseline total lymphocyte counts and subpopulations were similar in the 4 treatment arms. Responding patients had a smaller decrease in total CD45(+) cell count (P = .005) compared with nonresponding patients at day 28. On univariate analysis, those who developed chronic GVHD had significantly higher CD8(+) cell counts at day 14 compared with those without it (P = .005). There was no significant association between baseline lymphocyte count and survival. On univariate analysis, among the patients with higher lymphocyte counts at days 14 and 28, there was a trend toward better survival at day 180, although this trend did not reach the predetermined threshold for significance. We found no significant differences in lymphocyte total or subpopulation counts among the 4 treatment arms, and no notable influence on outcomes.",2013,"We found no significant differences in lymphocyte total or subpopulation counts among the 4 treatment arms, and no notable influence on outcomes.",['patients with acute GVHD'],"['BMT-CTN', 'steroids plus pentostatin, mycophenolate mofetil, etanercept, or denileukin diftitox']","['Baseline total lymphocyte counts and subpopulations', 'baseline lymphocyte count and survival', 'total CD45(+) cell count', 'lymphocyte total or subpopulation counts', 'number of total lymphocytes, T cells, B cells, and lymphocytes expressing activation markers', 'CD8(+) cell counts', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]","[{'cui': 'C0917591', 'cui_str': 'CTN'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030896', 'cui_str': 'Pentostatin'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0717670', 'cui_str': 'denileukin diftitox'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}]",,0.0307618,"We found no significant differences in lymphocyte total or subpopulation counts among the 4 treatment arms, and no notable influence on outcomes.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': 'Hematologic Malignancies, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231, USA. Fbolano2@jhmi.edu'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Vincent T', 'Initials': 'VT', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Luznik', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2012.12.003']
1684,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND


Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder.
METHODS


The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response.
RESULTS


Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms.
CONCLUSIONS


Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157']
1685,24184336,Health-related quality of life of bone marrow versus peripheral blood stem cell donors: a prespecified subgroup analysis from a phase III RCT-BMTCTN protocol 0201.,"Hematopoietic stem cells can be procured from unrelated donors via either the bone marrow (BM) aspiration or peripheral blood stem cell (PBSC) collection methods. There is no evidence from prospective randomized trials in the unrelated donor setting about the relative health-related quality-of-life (HRQoL) benefits/costs to donors. The goals of this prospective longitudinal investigation were to describe and compare the donation-related HRQoL experiences of 332 BM and PBSC donors. Donors were interviewed before donation, 48 hours after donation, weekly until fully recovered, and at 6 and 12 months after donation. Before donation, BM donors had lower confusion, fewer concerns, and were more prepared for donation. Shortly after donation, BM donors reported more physical side effects. BM donors also reported more donation-related impact on their social activities. However, BM donors reported somewhat better psychological status and were more likely to indicate that the donation made their lives more meaningful. There were virtually no longer term differences in the experiences of the 2 donor groups, including no recovery time difference beginning 3 weeks after donation. Although BM donors may experience the process as more physically stressful and more psychologically beneficial in the short term, the longer term HRQoL consequences of BM and PBSC donors are similar.",2014,"There were virtually no longer term differences in the experiences of the 2 donor groups, including no recovery time difference beginning 3 weeks after donation.","['332 BM and PBSC donors', 'unrelated donors via either the bone marrow (BM) aspiration or peripheral blood stem cell (PBSC) collection methods']",['bone marrow versus peripheral blood stem cell donors'],['physical side effects'],"[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C0457411', 'cui_str': 'Harvesting of peripheral blood stem cells'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0176906,"There were virtually no longer term differences in the experiences of the 2 donor groups, including no recovery time difference beginning 3 weeks after donation.","[{'ForeName': 'Galen E', 'Initials': 'GE', 'LastName': 'Switzer', 'Affiliation': 'Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Clinical and Translational Science, University of Pittsburgh, Pittsburgh, Pennsylvania. Electronic address: SwitzerGE@upmc.edu.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Bruce', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haagenson', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota; National Marrow Donor Program, Minneapolis, Minnesota.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Drexler', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Foley', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Confer', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bishop', 'Affiliation': 'University of Florida, College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Anderlini', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Leitman', 'Affiliation': 'NIH Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'University of Florida, College of Medicine, Gainesville, Florida.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2013.10.024']
1686,24064461,Modulation of motor cortex excitability in obsessive-compulsive disorder: an exploratory study on the relations of neurophysiology measures with clinical outcome.,"Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA) showed clinical benefit in obsessive-compulsive disorder (OCD). Here we tested whether clinical improvement was associated with enhanced cortical inhibition as measured by single and paired-pulse TMS variables. In 18 OCD patients receiving 4 weeks of either active or sham rTMS in a double-blind randomized trial, we assessed bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF). We tested correlations between changes in Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures. Active rTMS increased right hemisphere RMT whose change correlated with Y-BOCS-SR improvement. Baseline RMT hemispheric asymmetry, defined as the difference between left and right hemispheres RMT, and its normalization after active rTMS correlated with Y-BOCS-SR and CGI-S improvements. Active rTMS also increased right hemisphere SICI whose change correlated with Y-BOCS-SR and CGI-S at week 4, and with normalization of baseline RMT hemispheric asymmetry. Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD. Correlations of neurophysiology measures with therapeutic outcome are supportive of the role of SMA in the modulation of OCD symptoms.",2013,Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD.,"['obsessive-compulsive disorder', '18 OCD patients receiving 4 weeks of either']","['Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA', 'active or sham rTMS', 'Active rTMS']","['enhanced cortical inhibition', 'bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF', 'Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures', 'right hemisphere RMT', 'cortical excitability measures', 'Baseline RMT hemispheric asymmetry', 'right hemisphere SICI']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0444966', 'cui_str': 'ICF'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",18.0,0.0975713,Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mantovani', 'Affiliation': 'Division of Experimental Therapeutics, Department of Psychiatry, Columbia University/New York State Psychiatric Institute, New York, NY, USA; Division of Psychiatry, Department of Neuroscience, Siena University, Siena, Italy. Electronic address: am2518@columbia.edu.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bassi', 'Affiliation': ''}, {'ForeName': 'Helen B', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Fallon', 'Affiliation': ''}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': ''}]",Psychiatry research,['10.1016/j.psychres.2013.08.054']
1687,32427280,Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast.,"STUDY QUESTION


Does exposure to preconceptional hysterosalpingography (HSG) with iodinated oil-based contrast affect neonatal thyroid function as compared to iodinated water-based contrast?
SUMMARY ANSWER


Preconceptional HSG with iodinated contrast did not influence the neonatal thyroid function.
WHAT IS KNOWN ALREADY


HSG is a commonly applied tubal patency test during fertility work-up in which either oil- or water-based contrast is used. Oil-based contrast contains more iodine compared to water-based contrast. A previous study in an East Asian population found an increased risk of congenital hypothyroidism (CH) in neonates whose mothers were exposed to high amounts of oil-based contrast during HSG.
STUDY DESIGN, SIZE, DURATION


This is a retrospective data analysis of the H2Oil study, a randomized controlled trial (RCT) comparing HSG with the use of oil- versus water-based contrast during fertility work-up. After an HSG with oil-based contrast, 214 women had an ongoing pregnancy within 6 months leading to a live birth compared to 155 women after HSG with water-based contrast.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Of the 369 women who had a live born infant, 208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n = 140). Thyroid function tests of these children were retrieved from the Dutch neonatal screening program, which includes the assessment of total thyroxine (T4) in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤ -0.8 SD score. Furthermore, amount of contrast medium used and time between HSG and conception were compared between the two study groups.
MAIN RESULTS AND THE ROLE OF CHANCE


Data were collected from 140 neonates conceived after HSG with oil-based (n = 76) or water-based (n = 64) contrast. The median T4 concentration was 87.0 nmol/l [76.0-96.0] in the oil group and 90.0 nmol/l [78.0-106.0] in the water group (P = 0.13). None of the neonates had a positive screening result for CH.The median amount of contrast medium used was 9.0 ml [interquartile range (IQR), 6.0-11.8] in the oil-group and 10.0 ml [IQR, 7.5-14.0] in the water group (P = 0.43). No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
LIMITATIONS, REASONS FOR CAUTION


A relatively small sample size and possible attrition at follow-up are limitations of this study. Although our results suggest that the use of iodinated contrast media for HSG is safe for the offspring, the impact of a decrease in maternal thyroid function on offspring neurodevelopment could not be excluded, as data on maternal thyroid function after HSG and during conception were lacking.
WIDER IMPLICATIONS OF THE FINDINGS


As HSG with oil-based contrast does not affect thyroid function of the offspring, there is no reason to withhold this contrast to infertile women undergoing HSG. Future studies should investigate whether HSG with iodinated contrast influences the periconceptional maternal thyroid function and, consequently, offspring neurodevelopment.
STUDY FUNDING/COMPETING INTEREST(S)


This study received no funding. The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (Academic Medical Center and VU University Medical Center) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and intrepretation of the data. I.R. reports receiving travel fee from Guerbet. C.B.L. reports speakers fee from Ferring in the past and research grants from Ferring, Merck and Guerbet. K.D. reports receiving travel fee and speakers fee from Guerbet. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. V.M. reports receiving travel fee and speakers fee as well as research grants from Guerbet. The other authors do not report conflicts of interest.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl.",2020,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","['in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤\u2009-0.8 SD score', 'infertile women undergoing HSG', 'NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl', 'East Asian population', 'Of the 369 women who had a live born infant', '208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n\u2009=\u2009140']","['Oil-based contrast contains more iodine', 'HSG']","['neonatal thyroid function', 'maternal thyroid function', 'Thyroid function', 'risk of congenital hypothyroidism (CH', 'median T4 concentration', 'total thyroxine (T4', 'T4 concentrations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010308', 'cui_str': 'Congenital hypothyroidism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]",214.0,0.03966,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Roest', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Portela', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, De Run 4600, 5504 DB, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Scenic Blvd, Clayton, VIC 3800, Australia.'}, {'ForeName': 'M J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Paediatric Endocrinology, Amsterdam UMC, Vrije Universiteit Amsterdam, Emma Children's Hospital, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa049']
1688,32426471,A brief social-belonging intervention in college improves adult outcomes for black Americans.,"Could mitigating persistent worries about belonging in the transition to college improve adult life for black Americans? To examine this question, we conducted a long-term follow-up of a randomized social-belonging intervention delivered in the first year of college. This 1-hour exercise represented social and academic adversity early in college as common and temporary. As previously reported in  Science , the exercise improved black students' grades and well-being in college. The present study assessed the adult outcomes of these same participants. Examining adult life at an average age of 27, black adults who had received the treatment (versus control) exercise 7 to 11 years earlier reported significantly greater career satisfaction and success, psychological well-being, and community involvement and leadership. Gains were statistically mediated by greater college mentorship. The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.",2020,"The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.","['Examining adult life at an average age of 27, black adults who had received the treatment (versus', 'black Americans']",['control) exercise'],"['career satisfaction and success, psychological well-being, and community involvement and leadership']","[{'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009476', 'cui_str': 'Community Involvement'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",,0.0276882,"The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.","[{'ForeName': 'Shannon T', 'Initials': 'ST', 'LastName': 'Brady', 'Affiliation': 'Department of Psychology, Wake Forest University, Greene Hall, P.O. Box 7778, Reynolda Hall, Winston-Salem, NC, USA.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Graduate School of Education and Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shoshana N', 'Initials': 'SN', 'LastName': 'Jarvis', 'Affiliation': 'Haas School of Business, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}]",Science advances,['10.1126/sciadv.aay3689']
1689,31401090,Smokeless tobacco: Risk factor for cardiovascular and breathing in young Indian adolescent.,"BACKGROUND


Teenagers are the foremost susceptible population to smokeless tobacco usage and limited studies have surveyed the influence of smokeless tobacco on cardiac and respiratory response.
OBJECTIVE


This study aims to measure consequence (cardiovascular and breathing) of smokeless tobacco usage (gutkha and chewing tobacco) among young Indian men.
METHOD


On random basis, the applicants were divided into Group I (n=50) - healthy control group, Group II (n=50) - smokeless tobacco users. Anthropometric measurements and recording of blood pressure (BP), pulse wave analysis (PWV), heart rate variability (HRV) and pulmonary function test (PFT) was performed.
RESULT


We observed that altogether anthropometric variables were comparable among all individuals. In blood pressure variable, except DBP, other variables for example SBP, PP and MAP were significantly increased in Group II individuals, once compare to Group I. Pulse wave analysis, (such as, AP, AIx, and SEVR), was comparable in individuals of both groups. As compare to Group I, HR was significantly increased in Group II. In HRV investigation, NN, VLF, LF, LF(nu), LF/HF were increased significantly and TSP, HF, HF(nu) were decreased significantly in Group II with compare to Group I. In PFT analysis, FVC was comparable among individuals of both the group and conversely, significant decrease in FEV 1 , FEV 1 /FVC, FEF 25-75  and PEFR in Group II when compare with Group I.
CONCLUSION


This study illustrate that smokeless tobacco practice has increasing adverse effects on cardiovascular as well as breathing system and become an important public health problem.",2019,"In HRV investigation, NN, VLF, LF, LF(nu), LF/HF were increased significantly and TSP, HF, HF(nu) were decreased significantly in Group II with compare to Group I.","['n=50) - smokeless tobacco users', 'young Indian men', 'young Indian adolescent']",['smokeless tobacco usage (gutkha and chewing tobacco'],"['TSP, HF, HF(nu', 'example SBP, PP and MAP', 'Anthropometric measurements and recording of blood pressure (BP), pulse wave analysis (PWV), heart rate variability (HRV) and pulmonary function test (PFT']","[{'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0241410', 'cui_str': 'Chews tobacco (finding)'}]","[{'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",,0.0198573,"In HRV investigation, NN, VLF, LF, LF(nu), LF/HF were increased significantly and TSP, HF, HF(nu) were decreased significantly in Group II with compare to Group I.","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Physiology, Government Medical College, Shivpuri, MP, India. Electronic address: arbindchoudhary111@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Qudeer', 'Affiliation': 'Department of Physiology, L.N. Medical College and J.K. Hospital, Bhopal, India.'}]",Hipertension y riesgo vascular,['10.1016/j.hipert.2019.03.002']
1690,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION


Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up.
METHODS


Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period.
RESULTS


Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms.
LIMITATIONS


As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors.
CONCLUSION


MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182']
1691,23478060,"Phase III randomized study of rituximab/carmustine, etoposide, cytarabine, and melphalan (BEAM) compared with iodine-131 tositumomab/BEAM with autologous hematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma: results from the BMT CTN 0401 trial.","PURPOSE


This clinical trial evaluated standard-dose radioimmunotherapy with a chemotherapy-based transplantation regimen followed by autologous hematopoietic cell transplantation versus rituximab with the same regimen in patients with relapsed diffuse large B-cell lymphoma (DLBCL).
PATIENTS AND METHODS


Patients with chemotherapy-sensitive persistent or relapsed DLBCL were randomly assigned to receive iodine-131 tositumomab (dosimetric dose of 5 mCi on day -19 and therapeutic dose of 0.75 Gy on day -12), carmustine 300 mg/m(2) (day -6), etoposide 100 mg/m(2) twice daily (days -5 to -2), cytarabine 100 mg/m(2) twice daily (days -5 to -2), and melphalan 140 mg/m(2) (day -1; B-BEAM) or rituximab 375 mg/m(2) on days -19 and -12 and the same chemotherapy regimen (R-BEAM).
RESULTS


Two hundred twenty-four patients were enrolled, with 113 patients randomly assigned to R-BEAM and 111 patients assigned to B-BEAM. Two-year progression-free survival (PFS) rates, the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P = .94) for B-BEAM, and the 2-year overall survival (OS) rates were 65.6% (95% CI, 55.3% to 74.1%) for R-BEAM and 61% (95% CI, 50.9% to 69.9%; P = .38) for B-BEAM. The 100-day treatment-related mortality rates were 4.1% (95% CI, 0.2% to 8.0%) for R-BEAM and 4.9% (95% CI, 0.8% to 9.0%; P = .97) for B-BEAM. The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P < .001).
CONCLUSION


The B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates for patients with chemotherapy-sensitive relapsed DLBCL. No differences in toxicities other than mucositis were noted.",2013,"The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P < .001).
","['Two hundred twenty-four patients were enrolled, with 113 patients randomly assigned to', 'Patients with chemotherapy-sensitive persistent or relapsed DLBCL', 'patients with relapsed diffuse large B-cell lymphoma (DLBCL', 'patients with chemotherapy-sensitive relapsed DLBCL', 'relapsed diffuse large B-cell lymphoma']","['autologous hematopoietic cell transplantation versus rituximab', 'rituximab/carmustine, etoposide, cytarabine, and melphalan (BEAM', 'iodine-131 tositumomab/BEAM with autologous hematopoietic cell transplantation', 'radioimmunotherapy', 'rituximab', 'melphalan', 'iodine-131 tositumomab (dosimetric dose of 5 mCi on day -19 and therapeutic dose of 0.75 Gy on day -12), carmustine 300 mg/m(2) (day -6), etoposide 100 mg/m(2) twice daily (days -5 to -2), cytarabine', 'R-BEAM']","['toxicities', '2-year PFS and OS rates', '2-year overall survival (OS) rates', 'progression-free survival (PFS) rates', 'mortality rates', 'maximum mucositis score']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0768182', 'cui_str': 'tositumomab/iodine (131I) tositumomab'}, {'cui': 'C0085101', 'cui_str': 'Immunoradiotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4080399', 'cui_str': 'Etoposide 100 MG [Etopophos]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",224.0,0.136252,"The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P < .001).
","[{'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Vose', 'Affiliation': 'Section of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE 68198-7680, USA. jmvose@unmc.edu'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Ayala', 'Affiliation': ''}, {'ForeName': 'Oliver W', 'Initials': 'OW', 'LastName': 'Press', 'Affiliation': ''}, {'ForeName': 'Craig H', 'Initials': 'CH', 'LastName': 'Moskowitz', 'Affiliation': ''}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Mineshi', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ambinder', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fenske', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Tomblyn', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2012.45.9453']
1692,31855907,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise-Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2020,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada', 'Twenty race finishers with mild to moderately symptomatic EAH']","['Oral Hypertonic Saline', 'sealed envelopes, containing the word either ""oral"" or ""IV', 'HTS', 'oral HTS', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
1693,31855906,"Efficacy of Intra-Articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2020,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['100 patients', 'Knee Osteoarthritis']","['PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone', 'Hyaluronic acid (HA', 'HA [PNs associated with HA (PNHA']","['knee function and pain', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function', 'adverse events', 'Knee Society Score total score and pain item']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
1694,31969108,A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex.,"BACKGROUND


Research in rare genetic syndromes associated with ASD is often hampered by the wide geographic distribution of families and the presence of medical comorbidities, such as epilepsy, that may preclude travel to clinical sites. These challenges can limit the sample size and generalizability of the cohorts included in both natural history studies and clinical trials. Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers an elevated risk for autism spectrum disorder (ASD), with social communication delays identified in this population as early as 12 months of age. Early identification of risk necessitates parallel testing of early intervention, prompting the first randomized controlled clinical trial of behavioral intervention for infants with TSC (NCT03422367). However, considerable early recruitment challenges have mandated the systematic identification of enrollment barriers followed by modification of the study design to address these barriers.
METHODS


Caregivers were interviewed regarding barriers to enrollment (phase 1). Adaptations to the intervention were made to address these barriers (phase 2). Outcomes based on this modification to the study design were defined by enrollment rate and participant demographics.
RESULTS


Qualitative reports from caregivers indicated that distance and time were the primary barriers to clinical trial enrollment. The intervention was then modified to a remote model, with at-home, parent-delivered intervention, and weekly video conferencing with interventionists at the study sites. Enrollment increased 10-fold (from 3 to 30 participants) within 1 year and included a more diverse and clinically representative cohort of infants.
CONCLUSION


The design and implementation of more scalable methods to disseminate research remotely can substantially improve access to clinical trials in rare neurodevelopmental disorders. The lessons learned from this trial can serve as a model for future studies not only in rare conditions, but in other populations that lack adequate access, such as families with limited financial or clinical resources. Continued efforts will further refine delivery methods to enhance efficiency and ease of these delivery systems for families.",2020,"Early identification of risk necessitates parallel testing of early intervention, prompting the first randomized controlled clinical trial of behavioral intervention for infants with TSC (NCT03422367).","['infants with TSC (NCT03422367', 'infants with tuberous sclerosis complex', 'Caregivers were interviewed regarding barriers to enrollment (phase 1']",['behavioral intervention'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041341', 'cui_str': 'Sclerosis Tuberosa'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]",[],[],30.0,0.103292,"Early identification of risk necessitates parallel testing of early intervention, prompting the first randomized controlled clinical trial of behavioral intervention for infants with TSC (NCT03422367).","[{'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Hyde', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, 90095, USA. chyde@mednet.ucla.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pizzano', 'Affiliation': 'UCLA Graduate School of Education and Information Studies, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'McDonald', 'Affiliation': 'UCLA Semel Institute, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Harvard Graduate School of Education, Boston, MA, 02115, USA.""}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'UCLA Semel Institute, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thiele', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Herscot Center for Tuberous Sclerosis Complex, Boston, MA, 02114, USA.'}, {'ForeName': 'Shafali S', 'Initials': 'SS', 'LastName': 'Jeste', 'Affiliation': 'UCLA Semel Institute, Los Angeles, CA, 90095, USA.'}]",Journal of neurodevelopmental disorders,['10.1186/s11689-019-9302-0']
1695,32423429,"Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study.","BACKGROUND


Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women.
METHODS


This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
DISCUSSION


This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.",2020,"Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
","['112 participants', 'feet of Korean women', 'hands and feet (CHHF) commonly affects Asian women, especially Korean women', 'Korean women']","['OKT and placebo', 'OKT', 'Onkyeong-tang', 'OKT treatment', 'placebo']","['efficacy and safety', 'Efficacy and safety', 'VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test', 'Visual Analog Scale (VAS) scores of CHF']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0343068', 'cui_str': 'Familial cold urticaria'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0343068', 'cui_str': 'Familial cold urticaria'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4704948', 'cui_str': 'Cold Shock'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",112.0,0.4159,"Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
","[{'ForeName': 'Kyou-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Otolaryngology, Dermatology, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.'}, {'ForeName': 'In-Sik', 'Initials': 'IS', 'LastName': 'Han', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Ho-Yeon', 'Initials': 'HY', 'LastName': 'Go', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Semyung University, 65 Semyeong-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Dong-Nyung', 'Initials': 'DN', 'LastName': 'Lee', 'Affiliation': 'Department of Gynecology Medicine, College of Korean Medicine, Semyung University, 63 Sangbang 4-gil, Chungju-si, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Jun-Sang', 'Initials': 'JS', 'LastName': 'Yu', 'Affiliation': 'Department of Sasang Constitutional Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. hiruok@sangji.ac.kr.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Sun', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. sunguy2001@hanmail.net.'}]",Trials,['10.1186/s13063-020-04265-7']
1696,32423462,"Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE).","BACKGROUND


Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN. However, the clinical efficacy of BLA may be diminished in these patients because they present with pathophysiological variations that compromise the pharmacokinetic (PK) parameters of these antibiotics. Optimised administration of BLA in prolonged infusions has demonstrated better clinical outcomes in critically ill patients. However, there is a paucity of data on the usefulness of this strategy in patients with FN. The aim of this study is to test the hypothesis that the administration of BLA would be clinically more effective by extended infusion (EI) than by intermittent infusion (II) in haematological patients with FN.
METHODS


A randomised, multicentre, open-label, superiority clinical trial will be performed. Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem will be randomised (1:1) to receive the antibiotic by EI (during half the time of the dosing interval) in the study group, or by II (30 min) in the control group. The primary endpoint will be clinical efficacy, defined as defervescence without modifying the antibiotic treatment administered within the first 5 days of therapy. The primary endpoint will be analysed in the intention-to-treat population. The secondary endpoints will be pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied.
DISCUSSION


Data on the usefulness of BLA administration in patients with FN are scant. Only three clinical studies addressing this issue have been published thus far, with contradictory results. Moreover, these studies had some methodological flaws that limit the interpretation of their findings. If this randomised, multicentre, phase IV, open-label, superiority clinical trial validates the hypothesis that the administration of BLA is clinically more effective by EI than by II in haematological patients with FN, then the daily routine management of these high-risk patients could be changed to improve their outcomes.
TRIAL REGISTRATION


European Clinical Trials Database: EudraCT 2018-001476-37. ClinicalTrials.gov, ID: NCT04233996.",2020,Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN.,"['patients with FN are scant', 'Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical', 'cancer patients with FN', 'critically ill patients', 'haematological patients with FN', 'patients with haematological malignancies', 'patients with FN', 'febrile neutropenia in haematologic patients']","['antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem', 'Broad-spectrum antipseudomonal β-lactam antibiotics (BLA', 'β-lactam antibiotics', 'BLA']","['intention-to-treat population', 'pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied', 'clinical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0055003', 'cui_str': 'cefepime'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",,0.151928,Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laporte-Amargos', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain. carlotagudiol@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnan', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Puerta-Alcalde', 'Affiliation': ""Infectious Diseases Department, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial de Barcelona, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carmona-Torre', 'Affiliation': 'Infectious Diseases Department, Clínica Universidad de Navarra, Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Huguet', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Badalona, Institut Josep Carreras (IJC), Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albasanz-Puig', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Parody', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garcia-Vidal', 'Affiliation': ""Infectious Diseases Department, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial de Barcelona, Barcelona, Spain.""}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Del Pozo', 'Affiliation': 'Infectious Diseases Department, Clínica Universidad de Navarra, Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Batlle', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Badalona, Institut Josep Carreras (IJC), Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tebé', 'Affiliation': 'Biostatistics Unit, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rigo-Bonnin', 'Affiliation': 'Clinical Laboratory Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': ""Pharmacy Department, Clinical Trial Unit, Institut Català d'Oncologia, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': 'Pharmacy Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tubau', 'Affiliation': 'Microbiology Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Trials,['10.1186/s13063-020-04323-0']
1697,31541242,Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial.,"BACKGROUND


Duration of viral shedding is a determinant of infectivity and transmissibility, but few data exist about oseltamivir's ability to alter viral shedding.
METHODS


From January 2012 through October 2017, a randomized, double-blinded multicenter clinical trial was conducted in adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina. Participants with influenza A or B and without risk factors for complications of influenza were screened for the study. Eligible participants were randomized to receive oseltamivir 75 mg or placebo twice daily for 5 days. The primary endpoint was the percentage of participants with virus detectable by polymerase chain reaction in nasopharyngeal swab at day 3.
RESULTS


Of 716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza. Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results. Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =; .010). The median time to alleviation of symptoms was 79.0 hours for the oseltamivir arm and 84.0 hours for the placebo arm (P =; .34) in those with confirmed influenza infection.
CONCLUSIONS


Oseltamivir decreased viral shedding in this low-risk population. However, in the population enrolled in this study, it did not significantly decrease the time to resolution of clinical symptoms.
CLINICAL TRIALS REGISTRATION


NCT01314911.",2020,"Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =;","['Participants with influenza A or B and without risk factors for complications of influenza were screened for the study', 'Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results', 'adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina', 'Eligible participants', 'Low-risk Adults With Influenza', '716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza']","['placebo', 'oseltamivir 75 mg or placebo', 'Oral Oseltamivir']","['percentage of participants with virus detectable by polymerase chain reaction', 'viral shedding', 'time to resolution of clinical symptoms', 'Virological Outcomes', 'median time to alleviation of symptoms']","[{'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",716.0,0.656102,"Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =;","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Weerawat', 'Initials': 'W', 'LastName': 'Manosuthi', 'Affiliation': 'Bamrasnaradura Infectious Diseases Institute, Department of Disease Control, Nonthaburi, Thailand.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick, Maryland.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hoppers', 'Affiliation': 'Clinical Research Solutions, Jackson, Tennessee.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Beasley', 'Affiliation': 'Health Concepts, Rapid City, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ison', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Immunocompromised Service, Hospital General De Agudos J. M. Ramos Mejía, Buenos Aires, Argentina.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Langlois', 'Affiliation': 'Social & Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoopes', 'Affiliation': 'AVR Laboratories LLC, Logan, Utah; and.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick, Maryland.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Operational Infectious Diseases, Naval Health Research Center, San Diego, California.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz634']
1698,22238561,A Diet and Exercise Intervention during Chemotherapy for Breast Cancer.,"Weight gain is an important concern that impacts on breast cancer outcomes and general health in survivorship. This randomized, pilot study evaluated whether or not women could comply with a weight control program that is initiated at the beginning of chemotherapy for breast cancer. The program sought to prevent weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity. The intervention was implemented using a telephone counseling approach that blended motivational interviewing with social cognitive theory. A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center. This represents 55% of eligible women referred to the study and indicates that interest in a healthy lifestyle program at the initiation of chemotherapy for breast cancer was high. Subjects who dropped out had significantly lower fruit and vegetable intakes and lower blood carotenoids at baseline than subjects who completed the study. Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention. Mean body fat from dual energy X-ray absorptiometry increased in the written materials arm and decreased in the intervention arm. Of the enrolled women, 75% completed 12 months on study and satisfaction with study participation was high. These data indicate that lifestyle intervention during breast cancer treatment is feasible during treatment with chemotherapy for breast cancer and benefits women in several domains.",2011,"Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention.","['A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center', 'Breast Cancer']","['lifestyle intervention', 'Diet and Exercise Intervention', 'telephone counseling approach that blended motivational interviewing with social cognitive theory', 'weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity']","['fruit and vegetable intakes and lower blood carotenoids', 'fruit and vegetable intakes, physical activity and breast cancer-specific well-being', 'Mean body fat from dual energy X-ray absorptiometry']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3714364', 'cui_str': 'Counseling approach'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",40.0,0.0118589,"Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ellsworth', 'Affiliation': ''}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Weldon', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}]",The open obesity journal,[]
1699,21962393,Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial.,"BACKGROUND


Autologous haemopoietic stem-cell transplantation (HSCT) improves survival in patients with multiple myeloma, but disease progression remains an issue. Allogeneic HSCT might reduce disease progression, but can be associated with high treatment-related mortality. Thus, we aimed to assess effectiveness of allogeneic HSCT with non-myeloablative conditioning after autologous HSCT compared with tandem autologous HSCT.
METHODS


In our phase 3 biological assignment trial, we enrolled patients with multiple myeloma attending 37 transplant centres in the USA. Patients (<70 years old) with adequate organ function who had completed at least three cycles of systemic antimyeloma therapy within the past 10 months were eligible for inclusion. We assigned patients to receive an autologous HSCT followed by an allogeneic HSCT (auto-allo group) or tandem autologous HSCTs (auto-auto group) on the basis of the availability of an HLA-matched sibling donor. Patients in the auto-auto group subsequently underwent a random allocation (1:1) to maintenance therapy (thalidomide plus dexamethasone) or observation. To avoid enrolment bias, we classified patients as standard risk or high risk on the basis of cytogenetics and β2-microglobulin concentrations. We used the Kaplan-Meier method to estimate differences in 3-year progression-free survival (PFS; primary endpoint) between patients with standard-risk disease in the auto-allo group and the best results from the auto-auto group (maintenance, observation, or pooled). This study is registered with ClinicalTrials.gov, number NCT00075829.
FINDINGS


Between Dec 17, 2003, and March 30, 2007, we enrolled 710 patients, of whom 625 had standard-risk disease and received an autologous HSCT. 156 (83%) of 189 patients with standard-risk disease in the auto-allo group and 366 (84%) of 436 in the auto-auto group received a second transplant. 219 patients in the auto-auto group were randomly assigned to observation and 217 to receive maintenance treatment, of whom 168 (77%) completed this treatment. PFS and overall survival did not differ between maintenance and observation groups and pooled data were used. Kaplan-Meier estimates of 3-year PFS were 43% (95% CI 36-51) in the auto-allo group and 46% (42-51) in the auto-auto group (p=0·671); overall survival also did not differ at 3 years (77% [95% CI 72-84] vs 80% [77-84]; p=0·191). Within 3 years, 87 (46%) of 189 patients in the auto-allo group had grade 3-5 adverse events as did 185 (42%) of 436 patients in the auto-auto group. The adverse events that differed most between groups were hyperbilirubinaemia (21 [11%] patients in the auto-allo group vs 14 [3%] in the auto-auto group) and peripheral neuropathy (11 [6%] in the auto-allo group vs 52 [12%] in the auto-auto group).
INTERPRETATION


Non-myeloablative allogeneic HSCT after autologous HSCT is not more effective than tandem autologous HSCT for patients with standard-risk multiple myeloma. Further enhancement of the graft versus myeloma effect and reduction in transplant-related mortality are needed to improve the allogeneic HSCT approach.
FUNDING


US National Heart, Lung, and Blood Institute and the National Cancer Institute.",2011,Kaplan-Meier estimates of 3-year PFS were 43% (95% CI 36-51) in the auto-allo group and 46% (42-51) in the auto-auto group (p=0·671); overall survival also did not differ at 3 years (77% [95% CI 72-84] vs 80% [77-84]; p=0·191).,"['patients with multiple myeloma', 'Between Dec 17, 2003, and March 30, 2007, we enrolled 710 patients, of whom 625 had standard-risk disease and received an', 'patients with multiple myeloma (BMT CTN 0102', 'enrolled patients with multiple myeloma attending 37 transplant centres in the USA', 'patients with standard-risk disease in the auto-allo group and the best results from the auto-auto group (maintenance, observation, or pooled', '189 patients with standard-risk disease in the auto-allo group and 366 (84%) of 436 in the auto-auto group received a second transplant', 'patients with standard-risk multiple myeloma', 'Patients (<70 years old) with adequate organ function who had completed at least three cycles of systemic antimyeloma therapy within the past 10 months were eligible for inclusion', '219 patients in the auto-auto group']","['random allocation (1:1) to maintenance therapy (thalidomide plus dexamethasone) or observation', 'Allogeneic HSCT', 'autologous HSCT followed by an allogeneic HSCT (auto-allo group) or tandem autologous HSCTs (auto-auto group', 'autologous HSCT', 'Autologous haemopoietic stem-cell transplantation (HSCT', 'Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation', 'HLA-matched sibling donor', 'allogeneic HSCT']","['Kaplan-Meier estimates of 3-year PFS', '3-year progression-free survival', 'overall survival', 'survival', 'adverse events', 'peripheral neuropathy', 'grade 3-5 adverse events', 'PFS and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0917591', 'cui_str': 'CTN'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",710.0,0.184394,Kaplan-Meier estimates of 3-year PFS were 43% (95% CI 36-51) in the auto-allo group and 46% (42-51) in the auto-auto group (p=0·671); overall survival also did not differ at 3 years (77% [95% CI 72-84] vs 80% [77-84]; p=0·191).,"[{'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'City of Hope Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Logan', 'Affiliation': ''}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': ''}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Alyea', 'Affiliation': ''}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': ''}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Comenzo', 'Affiliation': ''}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': ''}, {'ForeName': 'Ginna', 'Initials': 'G', 'LastName': 'Laport', 'Affiliation': ''}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': ''}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sahebi', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': ''}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Ewell', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Geller', 'Affiliation': ''}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': ''}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Maloney', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(11)70243-1']
1700,22847485,"Specificity of effects of cognitive behavior therapy on coping, acceptance, and distress tolerance in a randomized controlled trial for smoking cessation.","OBJECTIVE


Although there is extensive evidence of the efficacy of cognitive-behavioral therapy (CBT), it is less certain what potential mechanisms of change are specifically affected by CBT interventions. This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
METHOD


Using data from a randomized controlled trial of 8-session group CBT and a time-matched comparison condition for cigarette smokers, we evaluated CBT effects on compensatory coping skills, self-rated acceptance and behavioral markers of persistence and distress tolerance. Because depression proneness had moderated treatment response in the parent clinical trial (Kapson & Haaga, 2010), we tested not only main effects (CBT vs. comparison condition) but also moderated effects (treatment condition X depression proneness).
RESULTS


CBT significantly improved compensatory coping skills only among the less depression-prone participants, who were the subset of smokers who did not benefit from CBT in terms of smoking cessation outcomes. There were no specific effects of CBT on acceptance or behavioral persistence.
CONCLUSIONS


To the extent that CBT had specific effects on compensatory coping skills, it was for the participants who did not benefit clinically from the intervention. Much more theory-driven research on multiple candidate change mechanisms is needed to clarify how effective and specific treatments have their effects, for either patients in general or subsets of patients as in moderated effects.",2012,"This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
",['cigarette smokers'],"['cognitive-behavioral therapy (CBT', 'cognitive behavior therapy', 'CBT', '8-session group CBT']","['compensatory coping skills, acceptance, and distress tolerance or persistence', 'acceptance or behavioral persistence', 'compensatory coping skills', 'coping, acceptance, and distress tolerance', 'compensatory coping skills, self-rated acceptance and behavioral markers of persistence and distress tolerance']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0668348,"This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
","[{'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Kapson', 'Affiliation': 'American University, Washington, District of Columbia 20016–8062, USA.'}, {'ForeName': 'Meaghan A', 'Initials': 'MA', 'LastName': 'Leddy', 'Affiliation': ''}, {'ForeName': 'David A F', 'Initials': 'DA', 'LastName': 'Haaga', 'Affiliation': ''}]",Journal of clinical psychology,['10.1002/jclp.21903']
1701,22571201,Lenalidomide after stem-cell transplantation for multiple myeloma.,"BACKGROUND


Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma.
METHODS


Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15).
RESULTS


The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%).
CONCLUSIONS


Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00114101.).",2012,The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001).,"['Between April 2005 and July 2009', '460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression', 'patients with multiple myeloma', 'patients with myeloma']","['lenalidomide maintenance therapy', 'Lenalidomide', 'lenalidomide', 'placebo']","['progressive disease or had died', 'disease progression or had died', 'longer time to disease progression', 'toxicity and second cancers', 'median time to progression', 'overall survival', 'grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",460.0,0.498182,The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001).,"[{'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'McCarthy', 'Affiliation': 'Blood and Marrow Transplant Program, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. philip.mccarthy@roswellpark.org'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': ''}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': ''}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Hurd', 'Affiliation': ''}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Hassoun', 'Affiliation': ''}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': ''}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vij', 'Affiliation': ''}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Moreb', 'Affiliation': ''}, {'ForeName': 'Natalie Scott', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': ''}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Van Besien', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gentile', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Isola', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': ''}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Gabriel', 'Affiliation': ''}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Levitan', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McClune', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schlossman', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hars', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Postiglione', 'Affiliation': ''}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Barry', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bressler', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Seiler', 'Affiliation': ''}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Rosenbaum', 'Affiliation': ''}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': ''}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': ''}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': ''}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Linker', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1114083']
1702,32423455,The combination of methotrexate and cytosine arabinoside in newly diagnosed adult Langerhans cell histiocytosis: a prospective phase II interventional clinical trial.,"BACKGROUND


Langerhans Cell Histiocytosis (LCH) is a rare disease puzzling both children and adults, however outcome of adult patients is unfavorable. This prospective interventional trial aims to test the efficacy and safety of the combination of methotrexate and cytosine arabinoside in adult LCH patients.
METHOD


A total of 36 patients enrolled diagnosed with LCH and treated in our center from 1st Jan, 2014 to 30th Jun, 2016.
RESULT


Nineteen patients underwent the detection of BRAF mutation, with a positive rate of 21.1%. The overall response rate was 100%, only 16.7% achieved complete response. The overall regression rate of osseous lesions was 100%. Regression of central nervous system involvement was also favorable. After a median follow-up of 44 months, the estimated event-free survival was 48.9 months, the overall survival rate was 97.2%. The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively. Neutropenia and thrombocytopenia were the most common adverse effects.
CONCLUSION


The regimen of methotrexate and cytosine arabinoside (MA) is effective and safe in treating adult LCH patients, and timely preventions may be considered for the high incidence of hematological adverse effects.
TRIAL REGISTRATION


Trial No. NCT02389400 on Clinicaltrials.gov, registered on 10th Mar. 2015.",2020,"The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively.","['adult LCH patients', 'newly diagnosed adult Langerhans cell histiocytosis', '36 patients enrolled diagnosed with LCH and treated in our center from 1st Jan, 2014 to 30th Jun, 2016']","['methotrexate and cytosine arabinoside (MA', 'methotrexate and cytosine arabinoside', 'Langerhans Cell Histiocytosis (LCH']","['Neutropenia and thrombocytopenia', 'overall survival rate', 'efficacy and safety', 'overall response rate', 'overall regression rate of osseous lesions', 'estimated event-free survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019621', 'cui_str': 'Langerhans cell histiocytosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0019621', 'cui_str': 'Langerhans cell histiocytosis'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",36.0,0.186455,"The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Mingqi', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China. mhduan@sina.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Tienan', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Daobin', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}]",BMC cancer,['10.1186/s12885-020-06872-8']
1703,32423467,The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam.,"BACKGROUND


Eliminating hepatitis C is hampered by the costs of direct-acting antiviral treatment and the need to treat hard-to-reach populations. Access could be widened by shortening or simplifying treatment, but limited research means it is unclear which approaches could achieve sufficiently high cure rates to be acceptable. We present the statistical aspects of a multi-arm trial designed to test multiple strategies simultaneously and a monitoring mechanism to detect and stop individual randomly assigned groups with unacceptably low cure rates quickly.
METHODS


The VIETNARMS trial will factorially randomly assign patients to two drug regimens, three treatment-shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies (14 randomly assigned groups). We will use Bayesian monitoring at interim analyses to detect and stop recruitment into unsuccessful strategies, defined by more than 0.95 posterior probability that the true cure rate is less than 90% for the individual randomly assigned group (non-comparative). Final comparisons will be non-inferiority for regimens (margin 5%) and strategies (margin 10%) and superiority for adjunctive ribavirin. Here, we tested the operating characteristics of the stopping guideline for individual randomly assigned groups, planned interim analysis timings and explored power at the final analysis.
RESULTS


A beta (4.5, 0.5) prior for the true cure rate produces less than 0.05 probability of incorrectly stopping an individual randomly assigned group with a true cure rate of more than 90%. Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited. Groups with moderately low cure rates (80%) are likely to stop (0.7 probability) before overall recruitment finishes. Interim analyses 7, 10, 13 and 18 months after recruitment commences provide good probabilities of stopping inferior individual randomly assigned groups. For an overall true cure rate of 95%, power is more than 90% to confirm non-inferiority in the regimen and strategy comparisons, regardless of the control cure rate, and to detect a 5% absolute difference in the ribavirin comparison.
CONCLUSIONS


The operating characteristics of the stopping guideline are appropriate, and interim analyses can be timed to detect individual randomly assigned groups that are highly likely to have suboptimal performance at various stages. Therefore, our design is suitable for evaluating treatment-shortening or -simplifying strategies.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN61522291. Registered on 4 October 2019.",2020,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,['Vietnam'],"['shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies', 'ribavirin']",[],"[{'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}]",[],,0.124331,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'McCabe', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK. leanne.mccabe@ucl.ac.uk.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, 764 Vo Van Kiet, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Barnes', 'Affiliation': 'Oxford University, South Parks Road, OX1 3SY, Oxford, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Cooke', 'Affiliation': 'Imperial College London, SW7 2AZ, London, Kensington, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04350-x']
1704,31540867,"Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial.","BACKGROUND


Existing guidelines for management of type 2 diabetes recommend a patient-centred approach to guide the choice of pharmacological agents. Although glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT2) inhibitors are increasingly used as second-line agents, direct comparisons between these treatments are insufficient. In the SUSTAIN 8 trial, we compared the efficacy and safety of semaglutide (a GLP-1 receptor agonist) with canagliflozin (an SGLT2 inhibitor) in patients with type 2 diabetes.
METHODS


This was a double-blind, parallel-group, phase 3b, randomised controlled trial done at 111 centres in 11 countries. Eligible patients were at least 18 years old and had uncontrolled type 2 diabetes (HbA 1c  7·0-10·5% [53-91 mmol/mol]) on stable daily metformin therapy. Patients were randomly assigned (1:1) by use of an interactive web response system to subcutaneous semaglutide 1·0 mg once weekly or oral canagliflozin 300 mg once daily. The primary endpoint was change from baseline in HbA 1c , and the confirmatory secondary endpoint was change from baseline in bodyweight, both at week 52. The primary analysis population included all randomly assigned patients, using on-treatment data collected before initiation of rescue medication. The safety analysis was done on a population that included all patients exposed to at least one dose of trial product. The trial was powered for HbA 1c  and bodyweight superiority under reasonable assumptions. This trial is registered with ClinicalTrials.gov, NCT03136484.
FINDINGS


Between March 15, 2017, and Nov 16, 2018, 788 patients were randomly assigned to semaglutide 1·0 mg (394 patients) or canagliflozin 300 mg (394 patients). 739 patients completed the trial (367 in the semaglutide group and 372 in the canagliflozin group). From overall baseline mean, patients receiving semaglutide had significantly greater reductions in HbA 1c  and bodyweight than those receiving canagliflozin (HbA 1c  estimated treatment difference [ETD] -0·49 percentage points, 95% CI -0·65 to -0·33; -5·34 mmol/mol, 95% CI -7·10 to -3·57; p<0·0001; and bodyweight ETD -1·06 kg, 95% CI -1·76 to -0·36; p=0·0029). Gastrointestinal disorders, most commonly nausea, were the most frequently reported adverse events with semaglutide, occurring in 184 (47%) of 392 patients; whereas infections and infestations (defined using the Medical Dictionary for Regulatory Activities, version 21.0), most commonly urinary tract infections, occurred more frequently with canagliflozin, in 136 (35%) of 394 patients. Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin. One fatal adverse event confirmed unlikely to be caused by treatment occurred in the semaglutide group.
INTERPRETATION


Once-weekly semaglutide 1·0 mg was superior to daily canagliflozin 300 mg in reducing HbA 1c  and bodyweight in patients with type 2 diabetes uncontrolled on metformin therapy. These outcomes might guide treatment intensification choices.
FUNDING


Novo Nordisk.",2019,Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin.,"['739 patients completed the trial (367 in the semaglutide group and 372 in the canagliflozin group', 'patients with type 2 diabetes uncontrolled on', '111 centres in 11 countries', 'Between March 15, 2017, and Nov 16, 2018, 788 patients', 'Eligible patients were at least 18 years old and had uncontrolled type 2 diabetes (HbA 1c  7·0', '392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin', 'patients with type 2 diabetes']","['canagliflozin 300 mg in reducing HbA 1c  and bodyweight', 'canagliflozin (an SGLT2 inhibitor', 'once-weekly semaglutide versus daily canagliflozin', 'canagliflozin', 'metformin', 'metformin therapy', 'interactive web response system to subcutaneous semaglutide 1·0 mg once weekly or oral canagliflozin 300 mg once daily', 'glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT2) inhibitors']","['change from baseline in HbA 1c', 'HbA 1c  and bodyweight', 'adverse events', 'Efficacy and safety', 'efficacy and safety of semaglutide', 'infections and infestations', 'Gastrointestinal disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C3556568', 'cui_str': 'canagliflozin 300 MG [Invokana]'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0009450', 'cui_str': 'Infectious Diseases'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",739.0,0.357426,Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin.,"[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, Department of Clinical Sciences, UT Southwestern Medical Center, University of Texas, Dallas, TX, USA. Electronic address: ildiko.lingvay@UTSouthwestern.edu.'}, {'ForeName': 'Andrei-Mircea', 'Initials': 'AM', 'LastName': 'Catarig', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Centre for Endocrinology and Diabetes, Amrita Hospital, Kochi, India.'}, {'ForeName': 'Nanna L', 'Initials': 'NL', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Thielke', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Centre, Stevenage, UK.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30311-0']
1705,32423396,Effects of journal therapy counseling with anxious pregnant women on their infants' sleep quality: a randomized controlled clinical trial.,"BACKGROUND


Sleep is especially important for infants, since it stimulates the development of neural connections in their brains. Psychological stress such as anxiety could affect sleep quality. This study investigated the effects of journal therapy counseling sessions on the infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes).
METHODS


A total of 70 healthy women with gestational age of 28-31 weeks participated in this randomized controlled trial. The participants were randomly allocated into intervention and control groups using randomized block design. Three in-person journal therapy sessions and three telephone counseling sessions (2 between in-person sessions and 1 one month postpartum) were provided to those in the intervention group, while the control group only received routine care. The Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist were completed at two and four months postpartum. The Beck Anxiety Inventory (BAI) was completed during pregnancy, at the end of the intervention, and at two and four months postpartum, and the Ages and Stages Questionnaire (ASQ) was completed at 4 months postpartum. Data were analyzed using chi-square, independent t-test, ANCOVA and repeated measure ANOVA.
RESULTS


There was no significant difference between the two groups in demographic characteristics and baseline anxiety scores. The mean sleep quality score in infants two months of age (MD: -4.2; 95%CI: - 1.1 to - 7.2; P = 0.007) and four months of age (MD: -5.5; 95%CI: - 8.4 to - 2.7; P < 0.001) was significantly lower in the intervention group than that of those in the control group. Based on the repeated measure ANOVA results, the mean postpartum anxiety score of mothers in the intervention group was significantly lower than that of those in the control group (AMD: -7.7; 95%CI: - 5.5 to - 10.1; P < 0.001). There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
CONCLUSION


Journal therapy can decrease mothers' anxiety and improve the infants' sleep quality based on their perception. However, further studies are required before drawing any definitive conclusion.
TRIAL REGISTRATION NUMBER


Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: August 11, 2018. URL: https://en.irct.ir/trial/33211.",2020,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","['infants two months of age (MD', '70 healthy women with gestational age of 28-31\u2009weeks', ""anxious pregnant women on their infants' sleep quality""]","['journal therapy counseling sessions', 'telephone counseling sessions', 'control group only received routine care', 'journal therapy counseling']","['Beck Anxiety Inventory (BAI', 'mean postpartum anxiety score', 'demographic characteristics and baseline anxiety scores', ""mothers' anxiety"", 'mean sleep quality score', ""infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes"", 'frequency of exclusive breastfeeding, and anthropometric and developmental parameters', 'Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist', 'sleep quality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]","[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4761105', 'cui_str': 'Postpartum anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",70.0,0.0872959,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Esmaeilpour', 'Affiliation': 'Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02132-7']
1706,32423454,"Neck-specific strengthening exercise compared with sham ultrasound when added to home-stretching exercise in patients with migraine: study protocol of a two-armed, parallel-groups randomized controlled trial.","BACKGROUND


Migraine is a highly disabling condition and pharmacological treatment is the gold standard. However, several patients have also positive responses to the application of different manual techniques and therapeutic exercises in terms of reducing the intensity and frequency of migraine attacks. Nevertheless, the effects of a neck-specific exercise program have not yet been evaluated in these patients.
OBJECTIVE


To determine the effectiveness of a neck-specific exercise program in reducing the intensity and frequency of migraine attacks as compared to a sham ultrasound group.
METHODS


A two-armed, parallel-groups randomized controlled trial with 3 months of follow-up will be conducted. 42 individuals, both genders, aged between 18 and 55 years old with a medical diagnosis of migraine will be included. The intervention group will perform a protocol consisting of exercises for strengthening the muscles of the cervical spine. Participants within the sham ultrasound group will receive detuned ultrasound therapy in the upper trapezius muscle. Both groups will receive a weekly session for 8 weeks. The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
TRIAL REGISTRATION


This study was registered under access code RBT-8gfv5j in the Registro Brasileiro de Ensaios Clínicos (ReBEC) in November 28, 2016.
CONCLUSION


This study will aim to determine the efficacy of a neck-specific exercise program in reducing the frequency and intensity of migraine attacks. If the results show that a neck-specific exercise program is effective in reducing the frequency and intensity of migraine attacks, therapists will have a low cost and easily applicable tool to treat migraine.",2020,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","['patients with migraine', '42 individuals, both genders, aged between 18 and 55\u2009years old with a medical diagnosis of migraine will be included']","['sham ultrasound when added to home-stretching exercise', 'sham ultrasound group will receive detuned ultrasound therapy', 'neck-specific exercise program', 'Neck-specific strengthening exercise']","['frequency and intensity of migraine attacks', 'intensity and frequency of migraine attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0880203,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","[{'ForeName': 'Mariana Tedeschi', 'Initials': 'MT', 'LastName': 'Benatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil. mariana.benatto@gmail.com.'}, {'ForeName': 'Lidiane Lima', 'Initials': 'LL', 'LastName': 'Florencio', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Marcela Mendes', 'Initials': 'MM', 'LastName': 'Bragatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Fabíola', 'Initials': 'F', 'LastName': 'Dach', 'Affiliation': 'Department of Neurosciences and Behavioral Sciences - Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Bevilaqua-Grossi', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00313-w']
1707,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND


No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
METHODS


We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656.
FINDINGS


Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
INTERPRETATION


In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
FUNDING


Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9']
1708,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND


No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS


We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS


There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS


Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
1709,30796424,"Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.","BACKGROUND


Pragmatic end points, such as time-to-treatment discontinuation (TTD), defined as the date of starting a medication to the date of treatment discontinuation or death has been proposed as a potential efficacy end point for real-world evidence (RWE) trials, where imaging evaluation is less structured and standardized.
PATIENTS AND METHODS


We studied 18 randomized clinical trials of patients with metastatic non-small-cell lung cancer (mNSCLC), initiated after 2007 and submitted to U.S. Food and Drug Administration. TTD was calculated as date of randomization to date of discontinuation or death and compared to progression-free survival (PFS) and overall survival (OS) across all patients, as well as in treatment-defined subgroups [EGFR mutation-positive treated with tyrosine kinase inhibitor (TKI), EGFR wild-type treated with TKI, ALK-positive treated with TKI, immune checkpoint inhibitor (ICI), chemotherapy doublet with maintenance, chemotherapy monotherapy].
RESULTS


Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86-0.87) than with OS (0.68, 95% CI 0.67-0.69). Early TTD (PFS-TTD ≥ 3 months) occurred in 7.7% of patients overall, and was more common with chemo monotherapy (15.0%) while late TTD (TTD-PFS ≥ 3 months) occurred in 6.0% of patients overall, and was more common in EGFR-positive and ALK-positive patients (12.4% and 22.9%). In oncogene-targeted subgroups (EGFR positive and ALK positive), median TTDs (13.4 and 14.1 months) exceeded median PFS (11.4 and 11.3 months).
CONCLUSIONS


At the patient level, TTD is associated with PFS across therapeutic classes. Median TTD exceeds median PFS for biomarker-selected patients receiving oncogene-targeted therapies. TTD should be prospectively studied further as an end point for pragmatic randomized RWE trials only for continuously administered therapies.",2019,"Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86-0.87) than with OS (0.68, 95% CI 0.67-0.69).","['patients with non-small-cell lung cancer', 'patients with metastatic non-small-cell lung cancer (mNSCLC), initiated after 2007 and submitted to U.S. Food and Drug Administration']","['targeted therapy, immunotherapy, and chemotherapy', 'TKI, immune checkpoint inhibitor (ICI), chemotherapy doublet with maintenance, chemotherapy monotherapy']","['median PFS', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.276455,"Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86-0.87) than with OS (0.68, 95% CI 0.67-0.69).","[{'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Center for Drug Evaluation and Research; Oncology Center of Excellence, U.S. Food and Drug Administration, White Oak. Electronic address: gideon.blumenthal@fda.hhs.gov.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kehl', 'Affiliation': 'Lowe Center for Thoracic Oncology Dana Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mishra-Kalyani', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research; Oncology Center of Excellence, U.S. Food and Drug Administration, White Oak.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khozin', 'Affiliation': 'Center for Drug Evaluation and Research; Oncology Center of Excellence, U.S. Food and Drug Administration, White Oak.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Center for Drug Evaluation and Research; Oncology Center of Excellence, U.S. Food and Drug Administration, White Oak.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Oxnard', 'Affiliation': 'Lowe Center for Thoracic Oncology Dana Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research; Oncology Center of Excellence, U.S. Food and Drug Administration, White Oak.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz060']
1710,22956855,Evaluation of Viable Dynamic Treatment Regimes in a Sequentially Randomized Trial of Advanced Prostate Cancer.,"We present new statistical analyses of data arising from a clinical trial designed to compare two-stage dynamic treatment regimes (DTRs) for advanced prostate cancer. The trial protocol mandated that patients were to be initially randomized among four chemotherapies, and that those who responded poorly were to be rerandomized to one of the remaining candidate therapies. The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy. Of the one hundred and fifty study participants, forty seven did not complete their therapy per the algorithm. However, thirty five of them did so for reasons that precluded further chemotherapy; i.e. toxicity and/or progressive disease. Consequently, rather than comparing the overall success rates of the DTRs in the unrealistic event that these patients had remained on their assigned chemotherapies, we conducted an analysis that compared viable switch rules defined by the per-protocol rules but with the additional provision that patients who developed toxicity or progressive disease switch to a non-prespecified therapeutic or palliative strategy. This modification involved consideration of bivariate per-course outcomes encoding both efficacy and toxicity. We used numerical scores elicited from the trial's Principal Investigator to quantify the clinical desirability of each bivariate per-course outcome, and defined one endpoint as their average over all courses of treatment. Two other simpler sets of scores as well as log survival time also were used as endpoints. Estimation of each DTR-specific mean score was conducted using inverse probability weighted methods that assumed that missingness in the twelve remaining drop-outs was informative but explainable in that it only depended on past recorded data. We conducted additional worst-best case analyses to evaluate sensitivity of our findings to extreme departures from the explainable drop-out assumption.",2012,"The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy.","['Advanced Prostate Cancer', 'Of the one hundred and fifty study participants, forty seven did not complete their therapy per the algorithm', 'advanced prostate cancer']",[],"['efficacy and toxicity', 'log survival time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0002045'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",150.0,0.101857,"The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI 48109.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rotnitzky', 'Affiliation': ''}, {'ForeName': 'Xihong', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Randall E', 'Initials': 'RE', 'LastName': 'Millikan', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}]",Journal of the American Statistical Association,[]
1711,31916648,"The beneficial health effects of Nigella sativa on Helicobacter pylori eradication, dyspepsia symptoms, and quality of life in infected patients: A pilot study.","The aim of this study was to evaluate the effects of Nigella sativa (N. sativa) in addition to quadruple-therapy on Helicobacter pylori eradication, dyspepsia, biochemical-markers, and quality of life in infected patients. In this double-blind placebo-controlled clinical-trial, 51 H. pylori infected patients with functional dyspepsia were randomly assigned to treatment (quadruple-therapy with 2 g/day N. sativa) or placebo groups (quadruple-therapy with 2 g/day placebo) for 8 weeks. Serum levels of interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde, quality of life, dyspepsia, food-intake, body-weight, and body mass index (BMI) were evaluated at the baseline and at the end of the study. H. pylori eradication was evaluated at the end of the intervention. At the end of the study, H. pylori eradication was more in the N. sativa group compared with the placebo (p = .01). Weight, BMI, and dietary-intake (p < .05) increased significantly as compared with placebo. A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05). The differences of biochemical-markers and dyspepsia between the two groups were not significant. So, N. sativa supplementation with medical treatment may have beneficial effects on H. pylori eradication, weight, BMI, dietary-intake, and quality of life in infected patients.",2020,A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05).,"['infected patients', '51 H. pylori infected patients with functional dyspepsia']","['placebo', 'placebo groups (quadruple-therapy with 2\u2009g/day placebo', 'Nigella sativa', 'Nigella sativa (N. sativa']","['Helicobacter pylori eradication, dyspepsia symptoms, and quality of life', 'Weight, BMI, and dietary-intake', 'pylori eradication', ""patients' quality of life"", 'Helicobacter pylori eradication, dyspepsia, biochemical-markers, and quality of life', 'H. pylori eradication, weight, BMI, dietary-intake, and quality of life', 'H. pylori eradication', 'Serum levels of interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde, quality of life, dyspepsia, food-intake, body-weight, and body mass index (BMI', 'biochemical-markers and dyspepsia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",,0.184888,A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05).,"[{'ForeName': 'Mahvash', 'Initials': 'M', 'LastName': 'Alizadeh-Naini', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Yousefnejad', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Hejazi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6610']
1712,30946523,"Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial.","OBJECTIVES


To report the long-term oncological outcomes of a randomised trial comparing androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone in patients with locally advanced prostate cancer.
PATIENTS AND METHODS


In this multicentre phase III trial, patients were randomly assigned to ADT alone or ADT+EBRT. Leuprorelin 11.25 mg was administered for 3 years. The whole pelvis was treated at a dose of 46 Gy and the prostate with a boost from 20 to 28 Gy. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), disease-specific survival (DSS), locoregional PFS (LRPFS), metastasis-free survival (MFS), biochemical PFS (BPFS), and tolerance.
RESULTS


With a median follow-up of 7.3 years, 263 patients were included. The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% vs 7%; hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.17-0.39; P < 0.001); in patients with a baseline PSA level ≥50 ng/mL (HR 0.10, 95% CI 0.05-0.20; P < 0.001) and in patients with a baseline PSA level <50 ng/mL (HR 0.28, 95% CI 0.19-0.40; P < 0.001). The risk of death from prostate cancer was significantly reduced in the ADT+EBRT arm (sub-HR [SHR] 0.48, 95% CI 0.25-0.91; P = 0.02). The 8-year OS rate was 57% in the ADT arm and 65% in the ADT+EBRT arm (no significant difference). LRPFS was significantly in favour of the ADT+EBRT arm (SHR 0.61, 95% CI 0.42-0.89; P = 0.01). MFS was comparable between both arms (P = 0.88). Analysis of toxicities revealed acute lower tolerance in the ADT+EBRT arm, with a gradual decrease in intensity from 6 months after the end of EBRT.
CONCLUSIONS


These long-term results confirm the oncological benefit of combining EBRT with ADT in the treatment of locally advanced prostate cancer.",2020,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","['locally advanced prostate cancer', 'locally-advanced prostate cancer', 'With a median follow-up of 7.3 years, 263 patients were included', 'patients treated with locally advanced prostate cancer']","['Leuprorelin', 'Long-term androgen deprivation, with or without radiotherapy', 'ADT alone or ADT+EBRT', 'EBRT with ADT', 'androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone']","['progression-free survival (PFS', 'overall survival (OS), disease-specific survival (DSS), locoregional progression free survival (LPFS), metastasis-free survival (MFS), biochemical progression free survival (BPFS) and tolerance', 'MFS', '8-year PFS rate', '8-year OS rate', 'risk of death from prostate cancer', 'LPFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",263.0,0.383482,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mottet', 'Affiliation': 'Department of Urology, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}]",BJU international,['10.1111/bju.14768']
1713,32423392,Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT).,"BACKGROUND


A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. Milk fat globule membranes (MFGM) have shown to have functional components that are found in human milk, suggesting that addition of bovine sources of MFGM (bMFGM) to infant formula may promote beneficial outcomes potentially helping to narrow the gap between infants who receive human breast milk or infant formula. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother's own milk.
METHODS


Single center, double-blind, and parallel randomized controlled trial. Planned participant enrollment includes: infants exclusively receiving breast milk (n = 200; human milk reference group; HM) and infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age (n = 340). The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF). Primary outcomes will be: 1) Physical growth (Body weight, length, and head circumference) at 730 days of age; and 2) Cognitive development (Auditory Event-Related Potential) at 730 days of age. Data will be analyzed for all participants allocated to each study feeding group.
DISCUSSION


The results of this study will complement the knowledge regarding addition of bMFGM in infant formula including support of healthy growth and improvement of neurodevelopmental outcomes.
TRIAL REGISTRATION


NCT02626143, registered on December 10th 2015.",2020,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[""infants fed with a standard formula and a reference group of infants fed with mother's own milk"", 'infants who receive human breast milk or infant formula']","['arachidonic acid (ARA) (25\u2009mg/100\u2009kcal); 1.9\u2009g protein/100\u2009kcal; 1.2\u2009mg Fe/100\u2009kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF', 'Planned participant enrollment includes: infants exclusively receiving breast milk (n\u2009=\u2009200; human milk reference group; HM', ""cow's milk based infant formula that had docosahexaenoic (DHA"", 'Milk fat globule membranes (MFGM', 'feeding mode', 'bMFGM']","['infant growth and cognitive function', '1) Physical growth (Body weight, length, and head circumference) at 730\u2009days of age; and 2) Cognitive development (Auditory Event-Related Potential']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0388561', 'cui_str': 'MFGE8 protein, human'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",,0.14066,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Toro-Campos', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile. rosario.toro@inta.uchile.cl.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Algarín', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Peirano', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Peña', 'Affiliation': 'Psychology Department, Pontific Catholic University, Santiago, Chile.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Murguia-Peniche', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}]",BMC pediatrics,['10.1186/s12887-020-02087-9']
1714,32423446,A music- and game-based oral health education for visually impaired school children; multilevel analysis of a cluster randomized controlled trial.,"BACKGROUND


Visually impaired children encounter some challenges for their oral health. We aimed to compare the effectiveness of oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education for mothers, and ATP along with art package on the oral health status of visually impaired children.
MATERIALS AND METHODS


This cluster, randomized trial, included visually impaired children from preschool to 10th grade (32 classes, n = 200), in Tehran, Iran, in 2018-2019. A questionnaire was filled out through face to face interviews at baseline regarding age, gender, status of visual impairment, and place of residence. The Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP) were examined afterward. Classes were randomly assigned to three groups through simple randomization: 1. Art group (ATP, game-based, and music-based education (11 classes, n = 66); 2. Mothers group (children received ATP and their mothers received education by telephone (10 classes, n = 73); and 3. Control group (children received ATP (11 classes, n = 61). Children received reinforcement after 1 and 2 weeks. Follow-up oral examinations were performed after 1 and 2 months by a blind calibrated examiner. Descriptive statistics were performed using Chi-Square, and ANOVA tests by SPSS (version 22). In analytic statistics, two-level mixed-effects models for BOP and OHI-S were fitted using the Statistical Analysis Software (SAS) version 9.4. Both models fitted with the grouping variable and time (baseline, 1, and 2 months after interventions) as the fixed effects.
RESULTS


The mean age (SD) of the children was 12.29 (3.45) years (range: 6-17). Male children (67%) more than female children (33%) participated in the study. Also, 35.5% were blind, and 12% resided at the dormitory. The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively). The time effect was statistically significant in both BOP and OHI-S models (P < 0.0001).
CONCLUSIONS


ATP technique is an effective method to improve the oral health status of visually impaired school children. Oral health promotion programs can be done using this method to tackle oral hygiene problems in visually impaired children.
TRIAL REGISTRATION


(https://www.irct.ir/trial/34676: Nov 29th, 2018).",2020,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","['included visually impaired children from preschool to 10th grade (32 classes, n\u2009=\u2009200), in Tehran, Iran, in 2018-2019', 'visually impaired children', 'Mothers group (children received', 'mothers, and ATP along with art package on the oral health status of visually impaired children', 'Male children (67%) more than female children (33%) participated in the study', 'The mean age (SD) of the children was 12.29 (3.45) years', 'visually impaired school children']","['ATP', 'oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education', 'music- and game-based oral health education']","['OHI-S', 'BOP', 'BOP and OHI-S models', 'oral health status', 'Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP', 'BOP and OHI-S']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",,0.0972671,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Sharififard', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Sargeran', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. k-sargeran@tums.ac.ir.'}, {'ForeName': 'Mahdia', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC oral health,['10.1186/s12903-020-01131-5']
1715,32423463,Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial.,"BACKGROUND


The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated.
METHODS


The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model.
CONCLUSION


A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.",2020,A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected.,['nursing home residents'],['interprofessional care concept'],"['hospitalization', 'effectiveness, cost-effectiveness, and safety', 'hospital admissions', 'quality of life, quality of care, and medication safety']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],"[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0595669,A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Piotrowski', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany. piotrowski@wiwi.uni-wuppertal.de.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Burkholder', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Renaud', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Markus Alexander', 'Initials': 'MA', 'LastName': 'Müller', 'Affiliation': 'Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lehr', 'Affiliation': 'Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Laag', 'Affiliation': 'BARMER, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Meiser', 'Affiliation': 'Saarland Association of Statutory Health Insurance Physicians, Saarbrücken, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Manderscheid', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany.'}]",Trials,['10.1186/s13063-020-04325-y']
1716,31425780,Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis.,"BACKGROUND


Topical delgocitinib (JTE-052), a novel Janus kinase inhibitor, had been shown to be clinically effective in adults with atopic dermatitis (AD). However, the efficacy of topical delgocitinib in pediatric patients with AD remained unclear.
OBJECTIVE


We sought to evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD.
METHODS


In this phase 2 clinical study (JapicCTI-173553) Japanese patients aged 2 through 15 years with AD were randomized in a 1:1:1 ratio to receive 0.25% or 0.5% delgocitinib ointment or vehicle ointment twice daily for 4 weeks. The primary efficacy end point was the percentage change from baseline in the modified Eczema Area and Severity Index score at the end of treatment (EOT).
RESULTS


At EOT, modified Eczema Area and Severity Index scores in both delgocitinib groups were significantly reduced compared with that in the vehicle group. The least-squares mean percentage change from baseline was -54.2% in the 0.25% group and -61.8% in the 0.5% group versus -4.8% in the vehicle group (P < .001 for both comparisons). Similarly, all other efficacy parameters, including Investigator's Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group at EOT. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported.
CONCLUSIONS


Delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. These study results indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.",2019,"At EOT, the mEASI scores in both delgocitinib groups were significantly reduced compared with those in the vehicle group.","['pediatric patients with AD remained unclear', 'adult patients with atopic dermatitis (AD', 'Japanese patients aged 2 through 15 years with AD', 'pediatric patients with atopic dermatitis', 'pediatric patients with AD']","['delgocitinib ointment', 'Delgocitinib ointment', 'Topical delgocitinib (JTE-052', 'topical delgocitinib']","['tolerated', 'Adverse events', 'clinical signs and symptoms', 'mEASI scores', ""Investigator's Global Assessment and pruritus scores"", 'efficacy and safety', 'modified Eczema Area and Severity Index (mEASI) score at the end of treatment (EOT']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4508502', 'cui_str': 'JTE-052'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.055258,"At EOT, the mEASI scores in both delgocitinib groups were significantly reduced compared with those in the vehicle group.","[{'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco, Tokyo, Japan. Electronic address: takeshi.nagata@jt.com.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.004']
1717,32422456,Cognitive and emotional predictors of real versus sham repetitive transcranial magnetic stimulation treatment response in methamphetamine use disorder.,"BACKGROUND AND AIMS


Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) can effectively reduce cravings in methamphetamine use disorder (MUD). However, a considerable group still fails to respond. Cognitive and emotional disturbance, as well as impulsive features, are widespread in patients with MUD and might mediate the treatment response of rTMS. The purpose of this study is to figure out whether these variables can help predicting patients' responses to rTMS treatment.
METHODS


Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included. Patients were randomized to receive 20 sessions of real or sham rTMS. Intermittent theta burst protocols (iTBS) or sham iTBS were applied every weekday over the DLPFC for 20 daily sessions. Both groups received regular treatment. Craving induced by drug-related cue was measured before and after stimulation. Cognition was evaluated by using the CogState Battery. Baseline characteristics were collected through the Addiction Severity Index, Patient Health Questionnaire-9, General Anxiety Disorder Scale-7, and Barrett Impulsivity Scale-11.
RESULTS


Results showed that patients with MUD have worse spatial working memory, problem-solving ability, as well as depression and anxiety symptoms compared with healthy controls. Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group. Better cognitive and emotional functions means that patients have higher possibility for better response to real rTMS treatment.
CONCLUSIONS


This study suggests that cognitive, emotional and impulsive features could be used to predict the prospective treatment responses of rTMS in patients with MUD.",2020,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"['methamphetamine use disorder', 'Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included', 'patients with MUD']","['Intermittent theta burst protocols (iTBS) or sham iTBS', 'Repetitive transcranial magnetic stimulation (rTMS', '20 sessions of real or sham rTMS', 'real versus sham repetitive transcranial magnetic stimulation', 'rTMS']","['Craving', 'spatial working memory, problem-solving ability', 'Cognitive and emotional disturbance', 'depression and anxiety symptoms', 'Cognition and emotion']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",97.0,0.0306309,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"[{'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Congbin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.007']
1718,31855909,Changes on Tendon Stiffness and Clinical Outcomes in Athletes Are Associated With Patellar Tendinopathy After Eccentric Exercise.,"OBJECTIVE


Eccentric exercise is commonly used as a form of loading exercise for individuals with patellar tendinopathy. This study investigated the change of mechanical properties and clinical outcomes and their interrelationships after a 12-week single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT).
DESIGN


Randomized controlled trial.
SETTING


Outpatient clinic of a university.
PARTICIPANTS


Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months were randomized into exercise and combined groups.
INTERVENTIONS


The exercise group received a 12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT in the initial 6 weeks.
MAIN OUTCOME MEASURES


Tendon stiffness and strain were examined using ultrasonography and dynamometry. Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score were used to assess pain and dysfunction. These parameters were measured at preintervention and postintervention.
RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed. Significant correlations between changes in tendon stiffness and VISA-p score (ρ = -0.58, P = 0.05); alteration in tendon strain, pain intensity (ρ = -0.63, P = 0.03); and VISA-p score (ρ = 0.60, P = 0.04) were detected after the exercise program.
CONCLUSIONS


Eccentric exercise-induced modulation on tendon mechanical properties and clinical symptoms are associated in athletes with patellar tendinopathy.",2020,"RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","['Outpatient clinic of a university', 'athletes with patellar tendinopathy', 'individuals with patellar tendinopathy', 'Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months']","['Eccentric exercise', 'single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT', 'Eccentric exercise-induced modulation', '12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT']","['Tendon Stiffness and Clinical Outcomes', 'pain and dysfunction', 'Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score', 'Tendon stiffness and strain', 'reduction of intensity of pain', 'tendon stiffness and VISA-p score', 'tendon stiffness', 'tendon mechanical properties and clinical symptoms', 'tendon strain', 'tendon strain, pain intensity']","[{'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0434303', 'cui_str': 'Tendon strain (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0305104,"RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","[{'ForeName': 'Wai-Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Gabriel Yin-Fat', 'Initials': 'GY', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Therapy, Luoyang Orthopedic Hospital of Henan Province, Luoyang, Henan, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Masci', 'Affiliation': 'Pure Sports Medicine, London, United Kingdom.'}, {'ForeName': 'Siu-Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000562']
1719,31399378,"Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial.","BACKGROUND


Patients who are immunocompromised because of malignancy have an increased risk of herpes zoster and herpes zoster-related complications. We aimed to investigate the efficacy and safety of an inactivated varicella zoster virus (VZV) vaccine for herpes zoster prevention in patients with solid tumour or haematological malignancies.
METHODS


This phase 3, two-arm, randomised, double-blind, placebo-controlled, multicentre trial with an adaptive design was done in 329 centres across 40 countries. The trial included adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy. Patients were randomly assigned (1:1) to receive four doses of VZV vaccine inactivated by γ irradiation or placebo approximately 30 days apart. The patients, investigators, trial site staff, clinical adjudication committee, and sponsor's clinical and laboratory personnel were masked to the group assignment. The primary efficacy endpoint was herpes zoster incidence in patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of inactivated VZV vaccine or placebo). The primary safety endpoint was serious adverse events up to 28 days after the fourth dose in patients with solid tumour malignancies receiving chemotherapy. Safety endpoints were assessed in all patients who received at least one dose of inactivated VZV vaccine or placebo and had follow-up data. This trial is registered (NCT01254630 and EudraCT 2010-023156-89).
FINDINGS


Between June 27, 2011, and April 11, 2017, 5286 patients were randomly assigned to receive VZV vaccine inactivated by γ irradiation (n=2637) or placebo (n=2649). The haematological malignancy arm was terminated early because of evidence of futility at a planned interim analysis; therefore, all prespecified haematological malignancy endpoints were deemed exploratory. In patients with solid tumour malignancies in the modified intention-to-treat population, confirmed herpes zoster occurred in 22 of 1328 (6·7 per 1000 person-years) VZV vaccine recipients and in 61 of 1350 (18·5 per 1000 person-years) placebo recipients. Estimated vaccine efficacy against herpes zoster in patients with solid tumour malignancies was 63·6% (97·5% CI 36·4 to 79·1), meeting the prespecified success criterion. In patients with solid tumour malignancies, serious adverse events were similar in frequency across treatment groups, occurring in 298 (22·5%) of 1322 patients who received the vaccine and in 283 (21·0%) of 1346 patients who received placebo (risk difference 1·5%, 95% CI -1·7 to 4·6). Vaccine-related serious adverse events were less than 1% in each treatment group. Vaccine-related injection-site reactions were more common in the vaccine group than in the placebo group. In the haematological malignancy group, VZV vaccine was well tolerated and estimated vaccine efficacy against herpes zoster was 16·8% (95% CI -17·8 to 41·3).
INTERPRETATION


The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies.
FUNDING


Merck & Co, Inc.",2019,"The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies.
","['patients with solid tumour malignancies receiving', 'Between June 27, 2011, and April 11, 2017', 'patients with solid tumour malignancies', '329 centres across 40 countries', '5286 patients', 'patients with haematological malignancies', 'patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of', 'adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy', 'immunocompromised patients with malignancies', 'patients with solid tumour or haematological malignancies']","['chemotherapy', 'inactivated varicella zoster virus vaccine', 'placebo', 'VZV vaccine inactivated by γ irradiation or placebo', 'inactivated varicella zoster virus (VZV) vaccine', 'VZV vaccine inactivated by γ irradiation (n=2637) or placebo', 'inactivated VZV vaccine or placebo']","['serious adverse events', 'tolerated and estimated vaccine efficacy against herpes zoster', 'Vaccine-related injection-site reactions', 'Safety and efficacy', 'herpes zoster incidence', 'herpes zoster', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1346.0,0.768375,"The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies.
","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Department of Medicine, Chicago, IL, USA. Electronic address: kmullane@medicine.bsd.uchicago.edu.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Morrison', 'Affiliation': 'University of Minnesota, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Camacho', 'Affiliation': 'Oncology Consultants, Houston, TX, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Arvin', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Durrand', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Campbell', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ivan S F', 'Initials': 'ISF', 'LastName': 'Chan', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Parrino', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Popmihajlov', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Paula W', 'Initials': 'PW', 'LastName': 'Annunziato', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30310-X']
1720,32423941,Internet-based cognitive-behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial.,"INTRODUCTION


The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
METHODS AND ANALYSIS


The target study population will be pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.
ETHICS AND DISSEMINATION


The study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.
TRIAL REGISTRATION NUMBER


UMIN000038190; Pre-results.",2020,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[""pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan"", 'pregnant women']","['6-module internet CBT programme', 'Internet-based cognitive-behavioural therapy', 'smartphone-based cognitive-behavioural therapy (CBT']","['number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}]",,0.184564,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nishi', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan d-nishi@m.u-tokyo.ac.jp.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Obikane', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Natsu', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Naonori', 'Initials': 'N', 'LastName': 'Yasuma', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiya', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036482']
1721,31398258,Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation.,"STUDY QUESTION


Does the use of an online decision aid (DA) about fertility preservation (FP), in addition to standard counselling by a specialist in reproductive medicine, reduce decisional conflict compared to standard counselling alone?
SUMMARY ANSWER


Female cancer patients who could make use of the online DA had a significantly lower short-term decisional conflict score.
WHAT IS KNOWN ALREADY


Nowadays, female cancer patients have several options for preserving fertility, but having to decide whether to opt for FP within a short time frame after cancer diagnosis and before the start of treatment is challenging. According to previous studies focussing mainly on breast cancer patients, decisional conflict among these women is high, and they have expressed the need for additional support.
STUDY DESIGN, SIZE, DURATION


The study was a randomized controlled trial including female cancer patients who were referred by their treating oncologist to a specialist in reproductive medicine for fertility counselling. Participants were randomly assigned to the control group (counselling only) or to the intervention group (counselling and additional use of the online DA immediately after counselling). Recruitment was ongoing from July 2016 to December 2017 at eight fertility centres in Switzerland and Germany.
PARTICIPANTS/MATERIALS, SETTING, METHODS


The online DA was developed by an interdisciplinary team of specialists in reproductive medicine, gynaecologists, oncologists and psychologists. Of 79 recruited participants, 59 completed the first assessment and could therefore be enrolled in the study. They were asked to complete an online questionnaire at three time points: at T1, after counselling (control group, n = 27) or after counselling and the additional use of the DA (intervention group, n = 24); at T2, 1 month later (N = 41: control group, n = 23; intervention group, n = 18); and at T3, 12 months later (N = 37: control group, n = 20; intervention group, n = 17). The survey comprised questions about fertility-related knowledge, attitude towards FP, willingness to undergo FP and socio-demographic data, as well as the decisional conflict and decisional regret scales.
MAIN RESULTS AND THE ROLE OF CHANCE


All participants showed low decisional conflict scores. Women who used the online DA in addition to counselling (intervention group) showed a significantly lower total score on the Decisional Conflict Scale (DCS) compared to the control group at T1 (P = 0.008; M = 12.15, SD = 4.38; 95% CI, 3.35-20.95) and at T2 (P = 0.043; M = 9.35, SD = 4.48; 95% CI, 0.31-18.38). At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51). The majority of participants had already made a decision regarding FP (yes or no) at T1 (72.5%): 91.7% in the intervention group compared to 55.6% in the control group (P = 0.014). Those who had decided already at T1 showed significantly lower decisional conflict (P = 0.007; M = 13.69, SD = 4.89; 95% CI, 3.86-23.52). The average number of DA sessions per user was 2.23, and 80.8% of the participants completed the DA's value clarification exercises. Participants in the intervention group were satisfied with the DA and would recommend it to other patients.
LIMITATIONS, REASONS FOR CAUTION


The recruitment of participants was challenging because of the emotionally difficult situation patients were in. This led to the limited sample size for final analysis. Education levels were high in two-thirds of the participants. It is difficult to say whether the DA would be equally effective in women with a lower educational background.
WIDER IMPLICATIONS OF THE FINDINGS


There is evidence that the DA served as a helpful complement to the decision-making process for young female cancer patients qualifying for FP. This is, to our knowledge, the first randomized controlled trial evaluating a DA targeted at patients with several cancer types and in a language other than English (i.e. German). This study contributes to extending the range of the still limited number of DAs in the context of FP.
STUDY FUNDING/COMPETING INTEREST(S)


The study was supported by a research grant of the Swiss Cancer Research. The authors declare that no competing interests exist.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, trial no. NCT02404883.
TRIAL REGISTRATION DATE


19 March 2015.
DATE OF FIRST PATIENT’S ENROLMENT


4 July 2016.",2019,"At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51).","['Of 79 recruited participants, 59 completed the first assessment and could therefore be enrolled in the study', 'The online DA was developed by an interdisciplinary team of specialists in reproductive medicine, gynaecologists, oncologists and psychologists', 'young female cancer patients qualifying for FP', 'patients with several cancer types and in a language other than English (i.e. German', 'Female cancer patients who could make use of the online DA', 'female cancer patients', 'female cancer patients who were referred by their treating oncologist to a specialist in reproductive medicine for fertility counselling', 'July 2016 to December 2017 at eight fertility centres in Switzerland and Germany', 'young female cancer patients regarding fertility preservation', 'women with a lower educational background']","['online decision aid', 'control group (counselling only) or to the intervention group (counselling and additional use of the online DA immediately after counselling', 'online decision aid (DA) about fertility preservation (FP']","['average number of DA sessions', 'decisional conflict', 'mean total score of the DCS', 'short-term decisional conflict score', 'total score on the Decisional Conflict Scale (DCS', 'low decisional conflict scores', 'Education levels']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1171194', 'cui_str': 'Fertility Preservation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1171194', 'cui_str': 'Fertility Preservation'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",79.0,0.110846,"At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51).","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ehrbar', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Urech', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rochlitz', 'Affiliation': 'Medical Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Zanetti Dällenbach', 'Affiliation': 'Gynecology and Gynaecologic Oncology, St. Claraspital Basel, Basel, Switzerland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moffat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stiller', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Germeyer', 'Affiliation': ""Division of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital, University Hospital of Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Nawroth', 'Affiliation': 'Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dangel', 'Affiliation': 'Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Findeklee', 'Affiliation': ""Obstetrics and Reproductive Medicine, University Women's Hospital Saarland, Homburg, Germany.""}, {'ForeName': 'Sibil', 'Initials': 'S', 'LastName': 'Tschudin', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez136']
1722,32423894,Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial.,"BACKGROUND


Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.
METHODS


In this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.
RESULTS


We developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
CONCLUSIONS


Treatment with rhTM might improve survival in AE-IIP cases with poor prognoses. Trial registration number UMIN000014969, date: 28 August 2014.",2020,"Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
","['AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with', '85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial', 'idiopathic interstitial pneumonia']","['intravenous rhTM', 'recombinant human soluble thrombomodulin (rhTM', 'rhTM therapy', 'conventional therapy without rhTM', 'recombinant thrombomodulin', 'rhTM']","['Survival', 'safety and efficacy', 'survival']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2350236', 'cui_str': 'Idiopathic interstitial pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085786', 'cui_str': 'Diffuse interstitial pulmonary fibrosis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",85.0,0.0411982,"Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Ogata', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hiroshima University, Hiroshima City, Hiroshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Marumo', 'Affiliation': 'Respiratory Disease Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Respiratory Medicine, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, Osaka, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Gohma', 'Affiliation': 'Department of Respiratory Medicine, Sakai City Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Osaka Minami Medical Center, Kawachinagano City, Osaka, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka City, Osaka, Japan.'}, {'ForeName': 'Chikatoshi', 'Initials': 'C', 'LastName': 'Sugimoto', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Akira', 'Affiliation': 'Department of Radiology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan giichiyi@me.com.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000558']
1723,31272495,HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya.,"BACKGROUND


The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya.
METHODS


The JiPime-JiPrEP (Kiswahili for 'Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months.
DISCUSSION


The findings from this trial can help to understand how HIVST-a new HIV-1 testing technology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.",2019,self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits.,"['Three distinct participant types will be enrolled: men (n\xa0=\u2009165) and women (n\xa0=\u2009165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n\xa0=\u2009165) who are\xa0at HIV-1 risk and not in a known serodiscordant relationship', 'Participants (n\xa0=\u2009495) are eligible for enrollment if they are at least 18\u2009years old, HIV-1 seronegative, and have been taking PrEP for 1 month', 'Kenya', 'human immunodeficiency virus-1 (HIV-1) prevention in Africa']","['pre-exposure prophylaxis (PrEP', 'HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs', 'self-testing (HIVST', 'HIVST']","['HIV-1', 'PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6\u2009months and secondarily at 12\u2009months']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.078652,self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits.,"[{'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Ortblad', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. katort@uw.edu.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Kearney', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mugwanya', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Irungu', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Nelly Rwamba', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}]",Trials,['10.1186/s13063-019-3521-2']
1724,32423936,Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.,"INTRODUCTION


Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.
METHODS AND ANALYSIS


A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations' newsletters.
TRIAL REGISTRATION NUMBER


NCT03963570.",2020,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","['older community-dwelling adults', 'Participants will be recruited throughout Sweden with enrolment through the project website', '1400 community-living older adults (70+ years) who experience impaired balance']","['exercise intervention', 'self-managed digital exercise programme', 'self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone', 'Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone']",['rate of falls (fall per person year'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.158995,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pettersson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden beatrice.pettersson@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Liv', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Zingmark', 'Affiliation': 'Health and Social Care Administration, Municipality of Östersund, Östersund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-036194']
1725,32423930,"Efficacy and safety of xuezhikang once per day versus two times per day in patients with mild to moderate hypercholesterolaemia (APEX study): a protocol for a multicentre, prospective randomised controlled, open-label, non-inferiority study.","INTRODUCTION


Reduction in low-density lipoprotein cholesterol (LDL-C) improves clinical outcomes in patients with coronary artery disease. However, rates of lipid-lowering medication adherence are far from ideal. Reducing dosage frequency from multiple dosing to once-daily dosing may improve patients' medication adherence. Xuezhikang (XZK), an extract of Chinese red yeast rice, contains a family of naturally occurring statins and is traditionally prescribed as 600 mg two times per day. A comParative Efficacy study of XZK (APEX study) is designed to test the hypothesis that XZK prescribed 1200 mg once per day (OD group) is non-inferior to 600 mg two times per day (TD group) in patients with hypercholesterolaemia.
METHODS AND ANALYSIS


The APEX study is a multicentre, prospective randomised controlled, open-label, non-inferiority study. We plan to recruit 316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention. Patients will be randomised (1:1) to OD group and TD group. The OD group take XZK 1200 mg once per day after dinner while TD group take a traditional dose of 600 mg, two times per day after meals. Participants will have an 8-week medication period and be followed up at weeks 0, 4 and 8. The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance. Data analyses will be on the intention-to-treat principle using non-inferiority analysis.
ETHICS AND DISSEMINATION


The research had been approved by the Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University ((2017)286). The results will be reported through peer-reviewed journals, seminars and conference presentations.
TRIAL REGISTRATION NUMBER


ChiCTR-IIR-17013660.",2020,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"['patients with mild to moderate hypercholesterolaemia (APEX study', 'patients with hypercholesterolaemia', '316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention', 'patients with coronary artery disease']","['XZK', 'xuezhikang', 'Xuezhikang (XZK']","['safety and lipid-lowering effect on other lipoproteins and compliance', 'rates of lipid-lowering medication adherence', 'Efficacy and safety', ""patients' medication adherence""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",316.0,0.138285,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"[{'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jingzhou', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ailan', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Dong-Dan', 'Initials': 'DD', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, The Eastern Hospital of the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Central Hospital of Panyu District, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China yilichen2018@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-034585']
1726,32423935,Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial.,"INTRODUCTION


Excessive salt intake is a public health concern due to its deleterious impact on health. Most of the salt consumed come from those that are added when cooking. This study will improve knowledge on the effectiveness of interventions to reduce salt consumption among consumers.
METHODS AND ANALYSIS


In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake. We will randomly select 260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, during which the participants will use the equipment at home to monitor and control their use of salt when cooking. The main outcome will be 24-hour urinary sodium excretion at baseline, at fourth and eighth weeks of intervention, and at 6 months after intervention.
ETHICS AND DISSEMINATION


Ethical approval for the study has been obtained from the Ethics Committee of the Centro Hospitalar Universitário São João. The results of the investigation will be published in peer-reviewed scientific papers and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03974477 EQUIPMENT PROVISIONAL PATENT NUMBER: Registered at INPI: 20191000033265.",2020,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","['260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension', 'workers from a public university']",[],['24-hour urinary sodium excretion'],"[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0781949,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Gonçalves', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal carlagoncalves.pt@gmail.com.'}, {'ForeName': 'Tânia', 'Initials': 'T', 'LastName': 'Silva-Santos', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Abreu', 'Affiliation': 'CIAFEL - Centro de Investigação em Atividade Física, Saúde e Lazer, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Padrão', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Esteves', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Norton', 'Affiliation': 'UP EPIUnit - Institute of Public Health, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moreira', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Olívia', 'Initials': 'O', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}]",BMJ open,['10.1136/bmjopen-2019-035898']
1727,21641663,Comorbid anxiety disorders and baseline medication regimens predict clinical outcomes in individuals with co-occurring bipolar disorder and alcohol dependence: Results of a randomized controlled trial.,"Despite the high prevalence and detrimental impact of alcoholism on bipolar patients, the diagnostic and treatment factors associated with better or worse clinical outcomes in alcohol-dependent patients with bipolar disorder are not well understood. The present study investigated the prospective impact of baseline psychiatric comorbidities and treatment regimens on clinical outcomes in bipolar alcoholics. Data were drawn from an 8-week randomized controlled clinical trial of acamprosate for individuals (n=30) with co-occurring bipolar disorder and alcohol dependence. Depressive and manic symptoms, and alcohol craving and consumption were monitored longitudinally using standardized instruments. Path analysis was used to estimate the prospective associations between patient characteristics and outcomes. More than 50% of patients were diagnosed with at least one anxiety (76.7%) or drug dependence disorder (60.0%). Comorbid anxiety disorders were prospectively associated with increased depressive symptoms and alcohol use. Participants were prescribed an average of 2.6 psychotropic medications at baseline. Antipsychotics and anticonvulsants were prospectively associated with increased alcohol use; anticonvulsants and benzodiazepines were associated with increased alcohol craving. Antidepressants were associated with increased depressive symptoms. Conversely, lithium was associated with decreased alcohol craving and depressive symptoms. The findings from the present study suggest areas for future research in this population.",2011,Antipsychotics and anticonvulsants were prospectively associated with increased alcohol use; anticonvulsants and benzodiazepines were associated with increased alcohol craving.,"['individuals with co-occurring bipolar disorder and alcohol dependence', 'individuals (n=30) with co-occurring bipolar disorder and alcohol dependence', 'bipolar alcoholics']","['acamprosate', 'benzodiazepines', 'lithium']","['alcohol craving', 'Depressive and manic symptoms, and alcohol craving and consumption', 'anxiety', 'alcohol craving and depressive symptoms', 'Comorbid anxiety disorders', 'depressive symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}]","[{'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",,0.0860135,Antipsychotics and anticonvulsants were prospectively associated with increased alcohol use; anticonvulsants and benzodiazepines were associated with increased alcohol craving.,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Prisciandaro', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry of Psychiatry and Behavioral Sciences, Clinical Neurosciences Division, 67 President Street, MSC861, Charleston, SC 29425, United States. Priscian@musc.edu'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Bryan K', 'Initials': 'BK', 'LastName': 'Tolliver', 'Affiliation': ''}]",Psychiatry research,['10.1016/j.psychres.2011.04.030']
1728,31538887,Comparison of the Efficacy of Repaglinide Versus the Combination of Mitiglinide and Voglibose on Glycemic Variability in Japanese Patients with Type 2 Diabetes.,"BACKGROUND


Glycemic variability is a risk factor for total death and cardiovascular events. There are no obvious guidelines for the direct treatment of glycemic variability, but it can be improved with the treatment of postprandial hyperglycemia.
OBJECTIVE


We compared the effect of repaglinide versus the combination of mitiglinide and voglibose, used to improve postprandial hyperglycemia, on glycemic variability in Japanese patients with type 2 diabetes.
METHODS


We performed an open-label randomized cross-over trial between April 2016 and April 2018. Patients with type 2 diabetes who were admitted to our hospital were enrolled in our study (n = 12). Glycemic variability. was assessed using a continuous glucose monitoring system.
RESULTS


The average glucose level of the repaglinide phase (146.1 ± 20.7 mg/dl) and the combination of mitiglinide and voglibose phase (132.3 ± 19.8 mg/dl) were similar (P = 0.10). The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
CONCLUSION


Treatment with the combination of mitiglinide and voglibose might be more effective than repaglinide for the improvement of glycemic variability.",2020,"The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
","['Japanese patients with type 2 diabetes', 'Patients with type 2 diabetes who were admitted to our hospital were enrolled in our study (n = 12']","['repaglinide', 'mitiglinide and voglibose']","['glycemic variability', 'postprandial hyperglycemia', 'Glycemic variability', 'mean amplitude of glycemic excursion', 'average glucose level']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0906166', 'cui_str': 'mitiglinide'}, {'cui': 'C0532578', 'cui_str': '3,4-dideoxy-4-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-2-C-(hydroxymethyl)-D-epi-inositol'}]","[{'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0208247,"The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Muhei', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Kyotamba Hospital, Kyoto, Japan.'}, {'ForeName': 'Goji', 'Initials': 'G', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Diabetes, Endocrinology, Nephrology and Rheumatology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Kadono', 'Affiliation': 'Department of Diabetes, Endocrinology, Nephrology and Rheumatology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Department of Pharmacy, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Oyamada', 'Affiliation': 'Department of Gastroenterology, Matsushita Memorial Hospital,Osaka, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Department of Surgery, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.'}]",Current pharmaceutical design,['10.2174/1381612825666190920124853']
1729,31537372,A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial.,"BACKGROUND


Globally, about 30% of women have experienced physical or sexual violence, or both, from an intimate partner during their lifetime. Associations between poverty and women's increased risk of intimate partner violence have been observed. We therefore aimed to assess the effect of a violence prevention intervention delivered to women participating in a group-based microfinance scheme in Tanzania.
METHODS


We did a cluster randomised controlled trial among women taking part in a microfinance loan scheme in Mwanza city, Tanzania. A microfinance loan group was only enrolled if at least 70% of members consented. We randomly assigned the microfinance groups in blocks of six to receive either the intervention (ie, the intervention arm) or be wait-listed for the intervention after the trial (ie, the control arm). Women in both arms of the trial met weekly for loan repayments. Only those in the intervention arm participated in the ten-session MAISHA intervention that aims to empower women and prevent intimate partner violence. Given the nature of the intervention, it was not possible to mask participants or the research team. The primary outcome was a composite of reported past-year physical or sexual intimate partner violence, or both. Secondary outcome measures were past-year physical, sexual, and emotional intimate partner violence; acceptability and tolerance of intimate partner violence; and attitudes and beliefs related to intimate partner violence. These outcomes were assessed 24 months after the intervention. An intention-to-treat analysis was done, adjusting for age, education, and baseline measure of the respective outcome. The study is registered with ClinicalTrials.gov, number NCT02592252.
FINDINGS


Between September, 2014, and June, 2015, 66 (65%) of 101 microfinance groups approached in the study area met the trial eligibility criteria and were enrolled, of which 33 (n=544 women) were allocated to the intervention arm and 33 (n=505 women) to the control arm. Overall, 485 (89%) of 544 women in the intervention arm and 434 (86%) of 505 in the control arm completed the outcomes assessment. Among the intervention arm, 112 (23%) of 485 women reported past-year physical or sexual intimate partner violence, or both, compared with 119 (27%) of 434 in the control arm (adjusted odds ratio [aOR] 0·69, 95% CI 0·47-1·01; p=0·056). Women in the intervention arm were less likely to report physical intimate partner violence (aOR 0·64, 95% CI 0·41-0·99; p=0·043) and were less likely to express attitudes accepting of intimate partner violence (0·45, 0·34-0·61; p<0·0001) or beliefs that intimate partner violence is a private matter (0·51, 0·32-0·81; p=0·005) or should be tolerated (0·68, 0·45-1·01; p=0·055). There was no evidence of an effect on reported sexual or emotional intimate partner violence. There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
INTERPRETATION


Reported physical or sexual intimate partner violence, or both, was reduced among women who participated in the intervention arm, although the effect was greater for physical intimate partner violence, suggesting that intimate partner violence is preventable in high-risk settings such as Tanzania.
FUNDING


Anonymous donor and STRIVE Consortium.",2019,"There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
","['women participating in a group-based microfinance scheme in Tanzania', 'intimate partner violence against women in a microfinance scheme in Tanzania', 'women taking part in a microfinance loan scheme in Mwanza city, Tanzania', 'Between September, 2014, and June, 2015, 66 (65%) of 101 microfinance groups approached in the study area met the trial eligibility criteria and were enrolled, of which 33 (n=544 women']","['violence prevention intervention', 'social empowerment intervention']","['composite of reported past-year physical or sexual intimate partner violence, or both', 'past-year physical or sexual intimate partner violence', 'sexual or emotional intimate partner violence', 'past-year physical, sexual, and emotional intimate partner violence; acceptability and tolerance of intimate partner violence; and attitudes and beliefs related to intimate partner violence', 'risk of intimate partner violence', 'report physical intimate partner violence', 'attitudes accepting of intimate partner violence', 'new episodes of violence or worsening of ongoing violence and abuse', 'intimate partner violence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}]",544.0,0.167183,"There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
","[{'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania; Department of Infectious Diseases Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania; Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: sheila.harvey@lshtm.ac.uk.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Christian Holm', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Mtolela', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Madaha', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Ramadhan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Kapinga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Mosha', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Abramsky', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30316-X']
1730,31537908,"Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.","BACKGROUND


Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
METHODS


In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.
RESULTS


BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
CONCLUSIONS


BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
CLINICAL TRIAL REGISTRATION


NCT01735071 (Clinicaltrials.gov).",2019,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","['women with partially platinum-sensitive recurrent ovarian cancer', 'women progressing between 6 and 12 months since their last platinum-based therapy']","['BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin', 'bevacizumab', 'trabectedin and bevacizumab', 'bevacizumab and trabectedin with or without carboplatin']","['efficacy and safety', 'progression-free survival rate (PFS-6) and severe toxicity rate (ST-6']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.202843,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zaccarelli', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Baldoni', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Frezzini', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palluzzi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'UO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Università di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'AO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'ASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Negri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pesenti Gritti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gerardi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': ""D'Incalci"", 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}]",British journal of cancer,['10.1038/s41416-019-0584-5']
1731,31538180,A proof of principle study of atomoxetine for the prevention of vasovagal syncope: the Prevention of Syncope Trial VI.,"AIMS


There are few effective therapies for vasovagal syncope (VVS). Pharmacological norepinephrine transporter (NET) inhibition increases sympathetic tone and decreases tilt-induced syncope in healthy subjects. Atomoxetine is a potent and highly selective NET inhibitor. We tested the hypothesis that atomoxetine prevents tilt-induced syncope.
METHODS AND RESULTS


Vasovagal syncope patients were given two doses of study drug [randomized to atomoxetine 40 mg (n = 27) or matched placebo (n = 29)] 12 h apart, followed by a 60-min drug-free head-up tilt table test. Beat-to-beat heart rate (HR), blood pressure (BP), and cardiac haemodynamics were recorded using non-invasive techniques and stroke volume modelling. Patients were 35 ± 14 years (73% female) with medians of 12 lifetime and 3 prior year faints. Fewer subjects fainted with atomoxetine than with placebo [10/29 vs. 19/27; P = 0.003; risk ratio 0.49 (confidence interval 0.28-0.86)], but equal numbers of patients developed presyncope or syncope (23/29 vs. 21/27). Of patients who developed only presyncope, 87% (13/15) had received atomoxetine. Patients with syncope had lower nadir mean arterial pressure than subjects with only presyncope (39 ± 18 vs. 69 ± 18 mmHg, P < 0.0001), and this was due to lower trough HRs in subjects with syncope (67 ± 30 vs. 103 ± 32 b.p.m., P = 0.006) and insignificantly lower cardiac index (2.20 ± 1.36 vs. 2.84 ± 1.05 L/min/m2, P = 0.075). There were no significant differences in stroke volume index (32 ± 6 vs. 35 ± 5 mL/m2, P = 0.29) or systemic vascular resistance index (2156 ± 602 vs. 1790 ± 793 dynes*s/cm5*m2, P = 0.72).
CONCLUSION


Norepinephrine transporter inhibition significantly decreased the risk of tilt-induced syncope in VVS subjects, mainly by blunting reflex bradycardia, thereby preventing final falls in cardiac index and BP.",2019,"Fewer subjects fainted with atomoxetine than with placebo [10/29 vs. 19/27; P = 0.003; risk ratio 0.49 (confidence interval 0.28-0.86)], but equal numbers of patients developed presyncope or syncope (23/29 vs. 21/27).","['Patients were 35\u2009±\u200914\u2009years (73% female) with medians of 12 lifetime and 3 prior year faints', 'Of patients who developed only presyncope, 87% (13/15) had received', 'healthy subjects', 'Vasovagal syncope patients']","['atomoxetine', 'Pharmacological norepinephrine transporter (NET) inhibition', 'Atomoxetine', 'placebo', 'atomoxetine 40\u2009mg (n\u2009=\u200927) or matched placebo']","['stroke volume index', 'presyncope or syncope', 'cardiac index', 'vasovagal syncope', 'nadir mean arterial pressure', 'tilt-induced syncope', 'systemic vascular resistance index', 'Beat-to-beat heart rate (HR), blood pressure (BP), and cardiac haemodynamics', 'risk of tilt-induced syncope']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0132800', 'cui_str': 'Norepinephrine Plasma Membrane Transport Proteins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1593716', 'cui_str': 'atomoxetine 40 MG [Strattera]'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.214221,"Fewer subjects fainted with atomoxetine than with placebo [10/29 vs. 19/27; P = 0.003; risk ratio 0.49 (confidence interval 0.28-0.86)], but equal numbers of patients developed presyncope or syncope (23/29 vs. 21/27).","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sheldon', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Guzman', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Kus', 'Affiliation': 'Department of Pharmacology and Physiology, Universite de Montreal, and Hopital du Sacre-Coeur, Montreal, Canada.'}, {'ForeName': 'Felix A', 'Initials': 'FA', 'LastName': 'Ayala-Paredes', 'Affiliation': 'Department of Medicine, University Hospital of Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Angihan', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Shahana', 'Initials': 'S', 'LastName': 'Safdar', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Maxey', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Bennett', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Satish R', 'Initials': 'SR', 'LastName': 'Raj', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Department of Cardiac Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz250']
1732,32424045,C-reactive protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation.,"BACKGROUND


Antibiotics are prescribed to >70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a C-reactive protein point-of-care test (CRP-POCT) management strategy for AECOPD in primary care resulted in a 20% reduction in patient-reported antibiotic consumption over 4 weeks.
AIM


To understand perceptions of the value of CRP-POCT for guiding antibiotic prescribing for AECOPD; explore possible mechanisms, mediators, and pathways to effects; and identify potential barriers and facilitators to implementation from the perspectives of patients and clinicians.
DESIGN AND SETTING


Qualitative process evaluation in UK general practices.
METHOD


Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study. Interviews were audio-recorded, transcribed, and analysed using framework analysis.
RESULTS


Patients and clinicians felt that CRP-POCT was useful in guiding clinicians' antibiotic prescribing decisions for AECOPD, and were positive about introduction of the test in routine care. The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients. Some clinicians thought the CRP-POCT should be routinely used in consultations for AECOPD; others favoured use only when there was decisional uncertainty. CRP-POCT cartridge preparation time and cost were potential barriers to implementation.
CONCLUSION


CRP-POCT-guided antibiotic prescribing for AECOPD had high acceptability, but commissioning arrangements and further simplification of the CRP-POCT need attention to facilitate implementation in routine practice.",2020,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","['Qualitative process evaluation in UK general practices', 'COPD exacerbations', 'Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study', 'patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD']","['C-reactive protein point-of-care test (CRP-POCT', 'C-reactive protein-guided antibiotic prescribing']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],20.0,0.0494891,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","[{'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Singh-Mehta', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gal', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Population Health and Environment Sciences, King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X709865']
1733,31477545,"Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care in patients with mild-to-moderate hypertension in Sri Lanka: a within-trial and modelled economic evaluation of the TRIUMPH trial.","BACKGROUND


Elevated blood pressure incurs a major health and economic burden, particularly in low-income and middle-income countries. The Triple Pill versus Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial showed a greater reduction in blood pressure in patients using fixed-combination, low-dose, triple-pill antihypertensive therapy (consisting of amlodipine, telmisartan, and chlorthalidone) than in those receiving usual care in Sri Lanka. We aimed to assess the cost-effectiveness of the triple-pill strategy.
METHODS


We did a within-trial (6-month) and modelled (10-year) economic evaluation of the TRIUMPH trial, using the health system perspective. Health-care costs, reported in 2017 US dollars, were determined from trial records and published literature. A discrete-time simulation model was developed, extrapolating trial findings of reduced systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality. The primary outcomes were the proportion of people reaching blood pressure targets (at 6 months from baseline) and disability-adjusted life-years (DALYs) averted (at 10 years from baseline). Incremental cost-effectiveness ratios were calculated to estimate the cost per additional participant achieving target blood pressure at 6 months and cost per DALY averted over 10 years.
FINDINGS


The triple-pill strategy, compared with usual care, cost an additional US$9·63 (95% CI 5·29 to 13·97) per person in the within-trial analysis and $347·75 (285·55 to 412·54) per person in the modelled analysis. Incremental cost-effectiveness ratios were estimated at $7·93 (95% CI 6·59 to 11·84) per participant reaching blood pressure targets at 6 months and $2842·79 (-28·67 to 5714·24) per DALY averted over a 10-year period.
INTERPRETATION


Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension. Scaled up investment in the triple pill for hypertension management in Sri Lanka should be supported to address the high population burden of cardiovascular disease.
FUNDING


Australian National Health and Medical Research Council.",2019,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","['Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial', 'patients with mild-to-moderate hypertension in Sri Lanka', 'patients with mild-to-moderate hypertension']","['amlodipine, telmisartan, and chlorthalidone', 'Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care', 'Triple Pill versus Usual Care Management']","['disability-adjusted life-years (DALYs) averted', 'systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality', 'proportion of people reaching blood pressure targets', 'blood pressure', 'Incremental cost-effectiveness ratios', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.167717,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Electronic address: tlung@georgeinstitute.org.au.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine with the Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India; The George Institute for Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Arjuna P', 'Initials': 'AP', 'LastName': 'de Silva', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Senaka', 'Initials': 'S', 'LastName': 'Rajapakse', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Gotabhaya', 'Initials': 'G', 'LastName': 'Ranasinghe', 'Affiliation': 'Institute of Cardiology, National Hospital of Sri Lanka, Colombo, Sri Lanka.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, India.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Hyderabad, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lea-Laba', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30343-2']
1734,31588902,Use of a Web-Based Dietary Assessment Tool (RiksmatenFlex) in Swedish Adolescents: Comparison and Validation Study.,"BACKGROUND


A Web-based dietary assessment tool-RiksmatenFlex-was developed for the national dietary survey of adolescents in Sweden.
OBJECTIVE


This study aimed to describe the Web-based method RiksmatenFlex and to test the validity of the reported dietary intake by comparing dietary intake with 24-hour dietary recalls (recall interviews), estimated energy expenditure, and biomarkers.
METHODS


Adolescents aged 11-12, 14-15, and 17-18 years were recruited through schools. In total, 78 students had complete dietary information and were included in the study. Diet was reported a few weeks apart with either RiksmatenFlexDiet (the day before and a random later day) or recall interviews (face-to-face, a random day later by phone) in a cross-over, randomized design. At a school visit, weight and height were measured and blood samples were drawn for biomarker analyses. Students wore an accelerometer for 7 days for physical activity measurements. Dietary intake captured by both dietary methods was compared, and energy intake captured by both methods was compared with the accelerometer-estimated energy expenditure (EEest). Intake of whole grain wheat and rye and fruit and vegetables by both methods was compared with alkylresorcinol and carotenoid concentrations in plasma, respectively.
RESULTS


The mean of the reported energy intake was 8.92 (SD 2.77) MJ by RiksmatenFlexDiet and 8.04 (SD 2.67) MJ by the recall interviews (P=.01). Intake of fruit and vegetables was 224 (169) g and 227 (150) g, and whole grain wheat and rye intake was 12.4 (SD 13.2) g and 12.0 (SD 13.1) g, respectively; the intakes of fruit and vegetables as well as whole grain wheat and rye did not differ between methods. Intraclass correlation coefficients ranged from 0.57 for protein and carbohydrates to 0.23 for vegetables. Energy intake by RiksmatenFlexDiet was overreported by 8% (P=.03) but not by the recall interviews (P=.53) compared with EEest. The Spearman correlation coefficient between reported energy intake and EEest was 0.34 (P=.008) for RiksmatenFlexDiet and 0.16 (P=.21) for the recall interviews. Spearman correlation coefficient between whole grain wheat and rye and plasma total alkylresorcinol homologs was 0.36 (P=.002) for RiksmatenFlexDiet and 0.29 (P=.02) for the recall interviews. Spearman correlations between intake of fruit and vegetables and plasma carotenoids were weak for both dietary tools. The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02).
CONCLUSIONS


RiksmatenFlexDiet provides information on energy, fruit, vegetables, and whole grain wheat and rye intake, which is comparable with intake obtained from recall interviews in Swedish adolescents. The results are promising for cost-effective dietary data collection in upcoming national dietary surveys and other studies in Sweden. Future research should focus on how, and if, new technological solutions could reduce dietary reporting biases.",2019,"The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02).
","['Adolescents aged 11-12, 14-15, and 17-18 years were recruited through schools', 'adolescents in Sweden', 'Swedish Adolescents', 'Swedish adolescents', '78 students had complete dietary information and were included in the study']","['Web-Based Dietary Assessment Tool (RiksmatenFlex', 'RiksmatenFlexDiet']","['Energy intake by RiksmatenFlexDiet', 'plasma total alkylresorcinol homologs', 'mean of the reported energy intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0334944,"The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02).
","[{'ForeName': 'Anna Karin', 'Initials': 'AK', 'LastName': 'Lindroos', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Petrelius Sipinen', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Axelsson', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Leanderson', 'Affiliation': 'Occupational and Environmental Medicine Center, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Arnemo', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Warensjö Lemming', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/12572']
1735,31317805,Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect.,"The stepped-wedge design for pragmatic clinical trials has received increased attention in health service-related research seeking to evaluate the effect of interventions. Compared with the parallel design, the stepped-wedge design is preferred when there is prior knowledge supporting the effectiveness and harmlessness of the intervention, and/or when practical or financial constraints exist such that the intervention can only be implemented sequentially on a fraction of clusters. In some health service studies, the study period may consist of two parts: an active implementation followed by a sustainability phase, where the intervention effect is possibly reduced. There is a gap in current literature of the stepped-wedge design for cluster randomization trials for dealing with this specific scenario. We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.",2019,We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.,[],[],[],[],[],[],,0.139839,We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'a Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University , Indianapolis , IN , USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'b Department of Biostatistics, College of Public Health, University of Nebraska Medical Center , Omaha , NE , USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'c Health Services Research Service, Richard L. Roudebush VA Medical Center , Indianapolis , IN , USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'c Health Services Research Service, Richard L. Roudebush VA Medical Center , Indianapolis , IN , USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1633658']
1736,31364501,Pump controlled retrograde trial off using the Cardiohelp console: safety considerations.,,2019,,[],[],[],[],[],[],,0.0665031,,"[{'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Mattke', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Haisz', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Black', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}]",Perfusion,['10.1177/0267659119865827']
1737,31302767,Oral cryotherapy for oral mucositis management in patients receiving allogeneic hematopoietic stem cell transplantation: a prospective randomized study.,"PURPOSE


To explore the best schedule of oral cryotherapy for the prevention of oral mucositis in recipients of myeloablative hematopoietic stem cell transplantation (HSCT).
METHODS


A prospective randomized study was conducted to recruit allogeneic HSCT recipients, who were then randomly allocated into four arms to accept the following: oral cryotherapy during the whole course (arm A) or second half of the course (arm B) of cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D). Status of oral mucositis was daily assessed from the first day of conditioning to the 15th day post-HSCT. A myeloablative conditioning regimen was used which was composed of busulfan, cyclophosphamide, and cytarabine.
RESULTS


Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment. Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678). The highest incidence of severe mucositis was observed in arm C. Recovery of mucositis also had a significant diversity among the 4 arms (F = 4.133, p = 0.008).
CONCLUSIONS


Risk and outcome of severe oral mucositis could be ameliorated by oral cryotherapy during the administration of cytotoxic agents for allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen, and a half-course schedule could acquire a comparable efficacy compared with the whole-course schedule.",2020,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","['allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen', 'recruit allogeneic HSCT recipients', 'recipients of myeloablative hematopoietic stem cell transplantation (HSCT', 'Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment', 'patients receiving allogeneic hematopoietic stem cell transplantation']","['oral cryotherapy', 'Oral cryotherapy', 'busulfan, cyclophosphamide, and cytarabine', 'cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D']","['Status of oral mucositis', 'severe mucositis', 'lower incidence and short duration of severe mucositis', 'mucositis', 'severe oral mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",160.0,0.0126175,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Xiaming', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Pingfang', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Shizhen', 'Initials': 'S', 'LastName': 'Teng', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Haifang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu Province, People's Republic of China. nswanghaifang@sina.com.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04966-z']
1738,20919760,The Treatment Advocacy Program: a randomized controlled trial of a peer-led safer sex intervention for HIV-infected men who have sex with men.,"OBJECTIVE


Primary care may be an effective venue for delivering behavioral interventions for sexual safety among HIV-positive men who have sex with men (MSM); however, few studies show efficacy for such an approach. We tested the efficacy of the Treatment Advocacy Program (TAP), a 4-session, primary-care-based, individual counseling intervention led by HIV-positive MSM ""peer advocates"" in reducing unprotected sex with HIV-negative or unknown partners (HIV transmission risk).
METHOD


We randomized 313 HIV-positive MSM to TAP or standard care. HIV transmission risk was assessed at baseline, 6 months, and 12 months (251 participants completed all study waves). We conducted intent-to-treat analyses using general estimating equations to test the interaction of group (TAP vs. standard care) by follow-up period.
RESULTS


At study completion, TAP participants reported greater transmission risk reduction than did those receiving standard care, χ2(2, N = 249) = 6.6, p = .04. Transmission risk among TAP participants decreased from 34% at baseline to about 20% at both 6 and 12 months: Transmission risk ranged from 23% to 25% among comparison participants.
CONCLUSIONS


TAP reduced transmission risk among HIV-positive MSM, although results are modest. Many participants and peer advocates commented favorably on the computer structure of the program. We feel that the key elements of TAP-computer-based and individually tailored session content, delivered by peers, in the primary care setting-warrant further exploration.",2010,Transmission risk among TAP participants decreased from 34% at baseline to about 20% at both 6 and 12 months:,"['HIV-positive men who have sex with men (MSM', 'HIV-infected men who have sex with men']","['behavioral interventions', 'peer-led safer sex intervention', 'TAP', 'Treatment Advocacy Program (TAP), a 4-session, primary-care-based, individual counseling intervention led by HIV-positive MSM ""peer advocates']","['HIV transmission risk', 'Transmission risk', 'transmission risk reduction']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",313.0,0.0414,Transmission risk among TAP participants decreased from 34% at baseline to about 20% at both 6 and 12 months:,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'McKirnan', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, Chicago, IL 60607, USA. davidmck@uic.edu'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tolou-Shams', 'Affiliation': ''}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Courtenay-Quirk', 'Affiliation': ''}]",Journal of consulting and clinical psychology,['10.1037/a0020759']
1739,31804186,A Web-Based Self-Titration Program to Control Blood Pressure in Patients With Primary Hypertension: Randomized Controlled Trial.,"BACKGROUND


Hypertension is a major cause of mortality in cardiac, vascular, and renal disease. Effective control of elevated blood pressure has been shown to reduce target organ damage. A Web-based self-titration program may empower patients to control their own disease, share decisions about antihypertensive dose titration, and improve self-management, ultimately improving health-related quality of life.
OBJECTIVE


Our primary aim was to evaluate the effects of a Web-based self-titration program for improving blood pressure control in patients with primary hypertension. Our secondary aim was to evaluate the effects of that program on improving health-related quality of life.
METHODS


This was a parallel-group, double-blind, randomized controlled trial with assessments at baseline, 3 months, and 6 months. We included patients with primary hypertension (blood pressure>130/80 mm Hg) from a cardiology outpatient department in northern Taiwan and divided them randomly into intervention and control groups. The intervention group received the Web-based self-titration program, while the control group received usual care. The random allocation was concealed from participants and outcome evaluators. Health-related quality of life was measured by the EuroQol five-dimension self-report questionnaire. We used generalized estimating equations to evaluate the effects of the intervention.
RESULTS


We included 222 patients and divided them equally into intervention (n=111) and control (n=111) groups. Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (-21.4 mm Hg and -5.4 mm Hg, respectively; P<.001) and 6 months (-27.8 mm Hg and -9.7 mm Hg, respectively; P<.001). Compared with the control group, the intervention group showed a significant decrease in the overall defined daily dose at both 3 (-0.202, P=.003) and 6 (-0.236, P=.001) months. Finally, health-related quality of life improved significantly in the intervention group compared with the control group at both 3 and 6 months (both, P<.001).
CONCLUSIONS


A Web-based self-titration program can provide immediate feedback to patients about how to control their blood pressure and manage their disease at home. This program not only decreases mean blood pressure but also increases health-related quality of life in patients with primary hypertension.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03470974; https://clinicaltrials.gov/ct2/show/NCT03470974.",2019,"Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (-21.4 mm Hg and -5.4 mm Hg, respectively; P<.001) and 6 months (-27.8 mm Hg and -9.7 mm Hg, respectively; P<.001).","['Patients With Primary Hypertension', 'patients with primary hypertension', 'patients with primary hypertension (blood pressure>130/80 mm Hg) from a cardiology outpatient department in northern Taiwan', '222 patients and divided them equally into intervention (n=111) and control (n=111) groups']","['Web-based self-titration program, while the control group received usual care', 'Web-based self-titration program']","['overall defined daily dose', 'mean blood pressure', 'blood pressure control', 'systolic and diastolic blood pressure control', 'health-related quality of life', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0005768'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",222.0,0.0743844,"Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (-21.4 mm Hg and -5.4 mm Hg, respectively; P<.001) and 6 months (-27.8 mm Hg and -9.7 mm Hg, respectively; P<.001).","[{'ForeName': 'Chi-Wen', 'Initials': 'CW', 'LastName': 'Kao', 'Affiliation': 'Department of Nursing, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Chung-Jen Junior College of Nursing, Health Sciences and Management, Chiayi, Taiwan.'}, {'ForeName': 'Shu-Meng', 'Initials': 'SM', 'LastName': 'Cheng', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Shiang', 'Initials': 'WS', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yue-Cune', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Mathematics, Tamkang University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/15836']
1740,31529084,Transitional Hypoglycaemia Management in Small for Gestational Age Neonates with Sucrose Enriched Expressed Breastmilk in Resource Poor Setting.,"AIM


To find out if oral sucrose is as efficacious as intravenous dextrose (IVDx) in treating hypoglycaemia in small for gestational age (SGA) neonates and to compare risk of feed intolerance (FI) and necrotizing enterocolitis (NEC) in oral therapy with IVDx therapy.
METHODS


Eighty SGA haemodynamically stable hypoglycaemic [blood sugar (BS) < 40 mg/dl] neonates of ≥32 to ≤36 week gestational age were randomized to receive oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy (Group B; 40 in each group) in similar calculated doses. BS at 6 h after treatment, incidence of recurrence of hypoglycaemia, FI and NEC were compared.
RESULTS


Mean BS level at 6 h after treatment in oral supplementation group was 63.53 ± 22.12 mg/dl [3.52 ± 1.22 mmol/l (IQR 49.2-82 mg/dl, 2.7-4.5 mmol/l) vs. 71.28 ± 31.76 mg/dl [3.96 ± 1.76 mmol/l (IQR 48.5-73 mg/dl, 2.69-4 mmol/l) in IVDx group, p = 0.209. Relative risk (RR) of recurrence of hypoglycaemia in oral vs. IV treatment was 1.5 with 95% CI 0.4578-4.9151. Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
CONCLUSION


In resource poor setting in haemodynamically stable hypoglycaemic SGA neonates, EBM enriched with calculated dose of sucrose given orally maintains euglycaemia (BS 40-125mg/dl, 2.2-6.9 mmol/l) without increased incidence of FI and NEC. This method also prevents lactational failure.",2020,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","['treating hypoglycaemia in small for gestational age (SGA) neonates', '\u200940 mg/dl] neonates of ≥32 to ≤36\u2009week gestational age', 'Eighty']","['oral sucrose', 'dextrose (IVDx', 'oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy']","['incidence of recurrence of hypoglycaemia, FI and NEC', 'Relative risk (RR) of recurrence of hypoglycaemia', 'Incidence of FI', 'Mean BS level', 'incidence of FI and NEC', 'SGA haemodynamically stable hypoglycaemic [blood sugar (BS', 'Transitional Hypoglycaemia Management']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0150254', 'cui_str': 'Hypoglycemia management'}]",80.0,0.148124,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Bora', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}, {'ForeName': 'Sumon', 'Initials': 'S', 'LastName': 'Deori', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz064']
1741,31534062,Different Influences of Statin Treatment in Preventing At-Risk Stroke Subtypes: A Post Hoc Analysis of J-STARS.,"AIMS


To understand the different influences of statins on the incidence rate of each stroke subtype in association with low-density lipoprotein (LDL) cholesterol levels, we performed a post hoc analysis on the data from the Japan Statin Treatment Against Recurrent Stroke (J-STARS) study.
METHODS


Subjects (n=1,578) were divided into three groups according to their mean postrandomized LDL cholesterol level (＜100, 100-120, and ≥ 120 mg/dL) until the last observation before the event or the end of follow-up. A Cox proportional hazard model for time to events was used for calculating adjusted hazard ratios, 95% confidence intervals, and the trend tests.
RESULTS


The event rates for atherothrombotic stroke did not decrease in accordance with the postrandomized LDL cholesterol level subgroups of either the control or the pravastatin group (p=0.15 and 0.33 for the trend, respectively). In the control group, however, no atherothrombotic stroke event was observed in the subgroup of the low postrandomized LDL cholesterol level (less than 100 mg/dL). The event rates for atherothrombotic stroke were lower in the middle postrandomized LDL cholesterol level subgroup (100-120 mg/dL) of the pravastatin group than that of the control group. The event rates for lacunar stroke decreased in the lower postrandomized LDL cholesterol level subgroup of the control group but not of the pravastatin group (p=0.004 and 0.06 for the trend, respectively).
CONCLUSIONS


Statins showed different influences on the risks of atherothromobotic and lacunar stroke according to postrandomized LDL cholesterol levels.",2020,"The event rates for lacunar stroke decreased in the lower postrandomized LDL cholesterol level subgroup of the control group but not of the pravastatin group (p=0.004 and 0.06 for the trend, respectively).
","['Subjects (n=1,578', 'At-Risk Stroke Subtypes']","['pravastatin', 'Statin']","['low postrandomized LDL cholesterol level', 'atherothrombotic stroke event', 'postrandomized LDL cholesterol level', 'risks of atherothromobotic and lacunar stroke', 'atherothrombotic stroke', 'lacunar stroke']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3178801', 'cui_str': 'Lacunar Syndrome'}]",,0.0419406,"The event rates for lacunar stroke decreased in the lower postrandomized LDL cholesterol level subgroup of the control group but not of the pravastatin group (p=0.004 and 0.06 for the trend, respectively).
","[{'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Hosomi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine.""}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Center for Clinical Research, Kobe University Hospital.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Medical Statistics, Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Nezu', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kagimura', 'Affiliation': 'Division of Medical Statistics, Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Center, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.50518']
1742,31532576,"Combined effects of glycerol and petrolatum in an emollient cream: A randomized, double-blind, crossover study in healthy volunteers with dry skin.","BACKGROUND


The stratum corneum plays an important protective physiological role in providing a barrier to preventing skin desiccation and penetration of external agents. Emollients are used commonly to improve barrier function and skin hydration.
AIMS


The primary objective of this study was to evaluate the effect of an emollient, V0034CR cream, and its active ingredients, to restore the cutaneous barrier. Secondary objectives included assessment of the moisturizing activity of each product and tolerance. The study was not designed to evaluate therapeutic benefit.
METHODS


In this randomized, double-blind, 4-arm crossover, clinical pharmacology study, the full emollient V0034CR, its vehicle formulation alone, or with glycerol, or petrolatum, was applied to the forearms of healthy volunteers (n = 51) with dry skin (Kligman score of 2 or 3). Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry were serially measured for 12 hours following application. An analysis of variance with repeated measures was performed on the evolution of TEWL and corneometry.
RESULTS


V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001).
CONCLUSIONS


The emollient V0034CR presented combined effects, with the petrolatum component improving skin barrier function, with a reduction in TEWL, and the glycerol component improving skin hydration.",2020,"RESULTS


V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001).
","['healthy volunteers with dry skin', 'healthy volunteers (n\xa0=\xa051) with dry skin (Kligman score of 2 or 3']","['emollient, V0034CR cream', 'glycerol, or petrolatum', 'glycerol and petrolatum']","['Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry', 'barrier function and skin hydration', 'moisturizing activity of each product and tolerance', 'skin barrier function', 'mean corneometry scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0151908', 'cui_str': 'Dry skin (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}]","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.130763,"RESULTS


V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001).
","[{'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Vaillant', 'Affiliation': 'CHRU Dermatology Department, University of Tours, INSERM U 1253 iBrain, Tours, France.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Georgescou', 'Affiliation': 'CHRU Dermatology Department, University of Tours, INSERM U 1253 iBrain, Tours, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Rivollier', 'Affiliation': 'Dermatology Department, Hôpital des Peupliers, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delarue', 'Affiliation': 'Pierre Fabre Dermatologie, Lavaur, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13163']
1743,31056655,High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial.,"BACKGROUND


The age-related decline in mass, strength, and performance of skeletal muscle is associated with loss of independence, falls risk, disability, institutionalization, and death.
METHODS


To determine whether a cocoa supplement enriched in flavonoids can improve plasma markers of oxidative stress and inflammation, physical performance and frailty in middle-aged and older subjects, we conducted a two-phase, randomized, double-blind, clinical trial. The initial study included 60 subjects (55- to 70-year-old) allocated into placebo (P), highly alkalinized (no-flavonoid; NF), or flavonoid-rich natural cocoa (F) beverage groups. The follow-up study included 74 older subjects (65- to 90-year-old) randomly distributed into NF or F groups. Subjects were instructed to consume the beverages once/day for up to 12-weeks. A comprehensive (aging relevant) set of end points were assessed, which included mean change in blood plasma metabolic and oxidative stress indicators, in physical performance tests and quality of life (QoL).
RESULTS


In the initial study, the F group showed improved glycemia, triglyceridemia, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, triglyceridemia/HDL index, and oxidative markers. Performance on the Up and Go test, skeletal muscle index, and quality of life also improved. In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress, and inflammatory endpoints and positive effects on physical performance, frailty indicators, and quality of life (F vs. NF group).
CONCLUSIONS


Regular flavonoids consumption positively affects blood oxidative stress and inflammation end points, cardiometabolic risk markers, physical performance, and quality of life. The sum of such effects may help to mitigate the extent of frailty development in the elderly people.
TRIAL REGISTRATION


NCT03585868.",2019,"In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL (F vs. NF group).
","['74 older subjects (65-90 year-old) randomly distributed into NF or F groups', 'middle and older age subjects', '60 subjects (55-70 year-old) allocated into', 'older subjects']","['cocoa supplement enriched in flavonoids', 'placebo (P), highly alkalinized (no-flavonoid; NF) or flavonoid rich natural cocoa (F) beverage groups', 'High flavonoid cocoa supplement']","['impact blood oxidative stress and inflammation endpoints, cardiometabolic risk markers, physical performance and QoL', 'Performance on the Up & Go test, skeletal muscle index, and QoL', 'plasma markers of oxidative stress and inflammation, physical performance and frailty', 'blood plasma metabolic and oxidative stress indicators, in physical performance tests and quality of life (QoL', 'mobility and quality of life', 'plasma oxidative stress and inflammation levels', 'glycemia, triglyceridemia (TG), c-HDL, c-LDL, the TG/HDL index, and oxidative markers', 'metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0596577', 'cui_str': 'Flavonoids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",74.0,0.48685,"In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL (F vs. NF group).
","[{'ForeName': 'Levy', 'Initials': 'L', 'LastName': 'Munguia', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rubio-Gayosso', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Ramirez-Sanchez', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Departamento de Ingenieria Bioquimica, Escuela Nacional de Ciencias Biologicas, Instituto Politecnico Nacional, Mexico.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hidalgo', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Meaney', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'Department of Medicine, School of Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Nayelli', 'Initials': 'N', 'LastName': 'Najera', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz107']
1744,31407010,"Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.",,2019,,"['hormone receptor-positive, HER2-negative advanced breast cancer']","['placebo plus letrozole', 'letrozole']",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.0289258,,"[{'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': ''}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': ''}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Yap', 'Affiliation': ''}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paluch-Shimon', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Petrakova', 'Affiliation': ''}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Blackwell', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Cameron', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Germa', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz215']
1745,32430445,Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.,"INTRODUCTION


The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery.
METHODS AND ANALYSIS


A parallel randomised controlled trial (772 participants) will be conducted. The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China. Participants will be randomly assigned to receive either a patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention (time point (T)1), 2 weeks (T2) and 1 year (T3) after the intervention. The control group receives a traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise. The primary study outcome is the informed decision, the percentage of patients who have adequate knowledge and demonstrate consistency between attitudes and intentions. Secondary outcomes include perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Zhongshan Ophthalmic Center (reference number: 2019KYPJ090). Results will be published in peer-reviewed journals and presented at scientific meetings for academic audiences.
TRIAL REGISTRATION NUMBER


NCT03992807.",2020,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","['patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China', '772 participants', 'patients with age-related cataract in China']","['patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention', 'traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise']","['perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439234', 'cui_str': 'year'}]",772.0,0.141142,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","[{'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China zhyfeng@mail.sysu.edu.cn.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}]",BMJ open,['10.1136/bmjopen-2019-032242']
1746,32430454,Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial.,"OBJECTIVE


To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.
DESIGN


Randomised controlled trial (RCT).
SETTING


BMJ Open 's quality improvement programme.
PARTICIPANTS


24 manuscripts describing RCTs.
INTERVENTIONS


We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.
OUTCOMES


The primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.
RESULTS


Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.
CONCLUSIONS


We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.
TRIAL REGISTRATION NUMBER


NCT03751878.",2020,"RESULTS


Manuscripts in the intervention group",['24 manuscripts describing RCTs'],['editorial intervention'],"['proportion of manuscripts', 'number of adequately reported items (0-8 scale']","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.116028,"RESULTS


Manuscripts in the intervention group","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain david.blanco.tena@upc.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Kirkham', 'Affiliation': 'Centre for Biostatistics, Manchester Academic Health Science Centre, Manchester University, Manchester, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Cobo', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-036799']
1747,32430455,Evaluating the real-world implementation of the Family Nurse Partnership in England: protocol for a data linkage study.,"INTRODUCTION


Almost 20 000 babies are born to teenage mothers each year in England, with poorer outcomes for mothers and babies than among older mothers. A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children. However, a randomised controlled trial in England found no effect on short-term primary outcomes, although cognitive development up to age 2 showed improvement. Our study will use linked routinely collected health, education and social care data to evaluate the real-world effects of the Family Nurse Partnership (FNP) on child outcomes up to age 7, with a focus on identifying whether the FNP works better for particular groups of families, thereby informing programme targeting and resource allocation.
METHODS AND ANALYSIS


We will construct a retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database. To assess the effectiveness of FNP, we will compare outcomes for eligible mothers ever and never enrolled in FNP, and their children, using two analysis strategies to adjust for measured confounding: propensity score matching and analyses adjusting for maternal characteristics up to enrolment/28 weeks gestation. Outcomes of interest include early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care. Subgroup analyses will determine whether the effect of FNP varied according to maternal characteristics (eg, age and education).
ETHICS AND DISSEMINATION


The Nottingham Research Ethics Committee approved this study. Mothers participating in FNP were supportive of our planned research. Results will inform policy-makers for targeting home visiting programmes. Methodological findings on the accuracy and reliability of cross-sectoral data linkage will be of interest to researchers.",2020,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"['retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database', 'young mothers and their children', 'eligible mothers ever and never enrolled in FNP, and their children', 'Mothers participating in FNP were supportive of our planned research']","['FNP', 'Family Nurse Partnership (FNP']","['early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care', 'cognitive development']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}]",,0.099084,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"[{'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Cavallaro', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wijlaars', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Eilis', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Children, Young Adults and Families Directorate, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Swarbrick', 'Affiliation': 'Family Nurse Partnership National Unit, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Harron', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK k.harron@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-038530']
1748,32430450,"Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC) for chronic insomnia disorder ('CANSLEEP' trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial.","INTRODUCTION


Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
METHODS AND ANALYSIS


A randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution ('ETC120') containing 10 mg Δ 9 -tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
ETHICS AND DISSEMINATION


Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
TRIAL REGISTRATION NUMBER


ANZCTRN12619000714189.",2020,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","['20 participants diagnosed with chronic insomnia disorder', 'participants with chronic insomnia disorder', 'people with insomnia disorder', 'Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019']","['Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC', ""oral oil solution ('ETC120') containing 10\u2009mg Δ 9 -tetrahydrocannabinol (THC) and 200\u2009mg cannabidiol (CBD"", 'oral cannabis-based medicine', 'active drug and matched placebo', 'placebo']","['sleep and daytime function', 'safety and efficacy', 'total sleep time and wake after sleep onset assessed via polysomnography']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",20.0,0.542876,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Suraev', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'Menzies Health Institute Queensland, School Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jonathon C', 'Initials': 'JC', 'LastName': 'Arnold', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia camilla.hoyos@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034421']
1749,32430452,Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease.,"INTRODUCTION


Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.
METHODS AND ANALYSIS


This trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


The study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union's Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03774329.",2020,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","['children and adolescents with inflammatory bowel disease (IBD', 'healthy populations', 'Eighty children with IBD', 'paediatric patients with IBD', 'children with inflammatory bowel disease']","['PA programme', 'programme with adapted physical exercises (intervention group) or usual PA (control group', 'Low bone mineral density (BMD', 'physical activity']","['BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.\nETHICS AND DISSEMINATION', 'bone health', 'whole-body BMD assessed by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",80.0,0.174414,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Vanhelst', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France jeremy.vanhelst@chru-lille.fr.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Coopman', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Lille University, Jeanne de Flandre Children's Hospital, Lille, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': 'Department of Paediatrics, Caen University Hospital F 14000 Caen, France and Normandy University, Caen, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bertrand', 'Affiliation': 'Pediatric Unit, Le Havre Hospital, Le Havre, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}]",BMJ open,['10.1136/bmjopen-2019-036400']
1750,32429867,Improving mental health literacy in year 9 high school children across Wales: a protocol for a randomised control treatment trial (RCT) of a mental health literacy programme across an entire country.,"BACKGROUND


Adolescence is a crucial period for developing and maintaining good habits for mental health and well-being. This is important for future mental health, as most mental health problems manifest during adolescence. Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents. The mental health literacy programme ""The Guide"", which was developed in Canada, has shown success in increasing mental health literacy in North American 16-17 year olds. ""The Guide Cymru"" is an adaptation of The Guide designed for a younger age group (13-14 year olds) and for the Welsh culture and context and is being offered to all state schools in Wales.
METHODS


This two-armed cluster randomised control trial (RCT) will evaluate the effectiveness of The Guide Cymru. All 205 secondary schools in Wales will be invited to take part, involving up to 30,000 year 9 pupils. Schools will be randomised to either the immediate implementation of The Guide Cymru or to a wait-list control. The wait-list control will receive The Guide Cymru around 12 weeks later. Measures of mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire) will be taken at baseline (pre-intervention), 12 weeks later (after the active group has received The Guide Cymru), and 24 weeks later (after the wait-list control has received The Guide Cymru).
DISCUSSION


The trial aims to evaluate if The Guide Cymru increases mental health literacy, including reduced stigma to others and to the self, and increased levels of good mental health behaviours and help-seeking for mental health problems.
TRIAL REGISTRATION


ISRCTN15462041. Registered 03/10/2019.",2020,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","['All 205 secondary schools in Wales will be invited to take part, involving up to 30,000\u2009year 9 pupils', 'year 9 high school children across Wales', 'mental health literacy in North American 16-17\u2009year olds']",['mental health literacy programme'],"['mental health literacy', 'mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",,0.0827054,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Simkiss', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Malone', 'Affiliation': 'Action for Children, Head Office: 3 The Boulevard, Ascot Road, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kemp', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Snowden', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, Wales, CF10 3AT, UK. snowden@cardiff.ac.uk.'}]",BMC public health,['10.1186/s12889-020-08736-z']
1751,32429851,Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine.,"BACKGROUND


Injection-site reactions have been reported with biologicals. In this post hoc analysis of Phase 3 studies in participants with migraine, we provide a comprehensive overview and detailed summary of injection-site reaction with galcanezumab.
METHODS


Data were obtained from two randomised clinical studies in participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one open-label study (Study CGAJ) in participants with episodic or chronic migraine. The injection-site reactions were measured for two different cohorts: 1) six-month double-blind treatment phase in the EVOLVE-1 and EVOLVE-2 studies and three-month double-blind treatment phase in the REGAIN study, where participants received placebo and galcanezumab (placebo-controlled analysis set); 2) three month double-blind (Month 0 to Month 3; 1:1:placebo:galcanezumab) + 9 months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ, where participants received only galcanezumab (galcanezumab exposure analysis set).
RESULTS


A total of 477 participants in the placebo-controlled analysis set (galcanezumab 240 mg, 166/730 [22.7%]; galcanezumab 120 mg, 128/705 [18.2%]; placebo, 183/1451 [12.6%]) reported at least one injection-site reaction. Most of the injection-site reactions were reported as injection-site pain, unspecified injection-site reaction, injection-site erythema, and injection-site pruritus. The incidence of injection-site pain was highest among all reported injection-site reactions and were reported with similar frequency by participants receiving galcanezumab (galcanezumab 120 mg, 10.1%; galcanezumab 240 mg, 11.6%) and placebo (9.5%) and was the most common injection-site reaction reported within 60 min of injection (~ 86% of participants). The frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus was significantly (P < 0.001) higher in participant receiving galcanezumab versus placebo. In the galcanezumab exposure analysis set participants received up to 12 doses and the frequency of injection-site reactions reported for both doses combined was 21.8%. The reporting of injection-site reactions did not increase with the number of doses received. No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
CONCLUSIONS


The most common adverse event of galcanezumab is injection-site reactions. However, these events were generally mild-to-moderate in severity, non-serious, resolved spontaneously, and discontinuations due to injection-site reactions were low (1%).",2020,"No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
","['participants with episodic or chronic migraine', 'participants with migraine', 'A total of 477 participants in the', 'participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one']","['galcanezumab', 'galcanezumab (galcanezumab', 'placebo and galcanezumab (placebo', 'galcanezumab versus placebo', 'galcanezumab (galcanezumab exposure analysis set', 'open-label study (Study CGAJ', 'placebo-controlled analysis set (galcanezumab', '1:1:placebo:galcanezumab)\u2009+\u20099 months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ', 'placebo']","['frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus', 'ISR-related serious adverse events', 'reporting of injection-site reactions', 'incidence of injection-site pain']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0852995', 'cui_str': 'Injection site pruritus'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",477.0,0.395407,"No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
","[{'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. vstauffer@lilly.com.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Bonner', 'Affiliation': 'St. Louis University Hospital, St Louis, USA.'}, {'ForeName': 'ByungKun', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhandari', 'Affiliation': 'Eli Lilly Services India Private Limited, Bangalore, India.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Day', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Camporeale', 'Affiliation': 'Eli Lilly Italia, Sesto Fiorentino, Italy.'}]",BMC neurology,['10.1186/s12883-020-01775-4']
1752,30946156,Cardiorespiratory fitness is associated with inflammation and physical activity in HIV+ adults.,"OBJECTIVE


Our objective was to examine the effect of a lifestyle diet and exercise intervention on cardiorespiratory fitness (CRF) and to examine predictors of change in CRF.
DESIGN


People living with HIV (PLHIV) are at increased risk for cardiovascular disease. CRF is a better predictor of cardiovascular disease-related mortality than established risk factors yet very little is known about CRF in PLHIV.
METHODS


One-hundred and seven virally suppressed PLHIV were randomized to a group-based intervention to improve lifestyle behaviors or a control condition. All PLHIV maximal cardiorespiratory stress test to determine VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2, at baseline and 6 months later. Participants wore an accelerometer to measure physical activity, completed waist-hip circumference measures, and had a fasting lipid profile, IL-6, and high sensitivity C-reactive protein analyzed. Generalized estimating equations were used to examine the effect of the intervention on CRF and predictors of change in CRF.
RESULTS


Participants were approximately 53 years old, 65% male (n = 70), and 86% African-American (n = 93). There was no effect of the intervention on markers of CRF over time (P > 0.05). After controlling for age, sex, waist-hip-ratio, the inflammatory biomarker IL-6 was inversely associated with a decline in both VO2 peak (P = 0.03) and VO2 at anaerobic threshold (P = 0.03). In addition, participants who walked an additional 10 000 steps per day had a 2.69 ml/kg per min higher VO2 peak (P = 0.02).
CONCLUSION


Despite HIV viral suppression, PLHIV had remarkably poor CRF and inflammation was associated with a clinically adverse CRF profile. However, increased physical activity was associated with improved CRF.",2019,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"['People living with HIV (PLHIV', 'HIV+ adults', 'Participants were approximately 53 years old, 65% male (n\u200a=\u200a70), and 86% African-American (n\u200a=\u200a93', 'One-hundred and seven virally suppressed PLHIV']","['CRF', 'lifestyle diet and exercise intervention', 'group-based intervention to improve lifestyle behaviors or a control condition']","['VO2 peak', 'markers of CRF over time', 'cardiorespiratory fitness (CRF', 'VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2', 'HIV viral suppression', 'physical activity', 'CRF and inflammation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",107.0,0.057033,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vest', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Vitor H F', 'Initials': 'VHF', 'LastName': 'Oliveira', 'Affiliation': 'Department of Exercise Physiology, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Longenecker', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Currie', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Josephson', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002154']
1753,30726886,Walking for Better Outcomes and Recovery: The Effect of WALK-FOR in Preventing Hospital-Associated Functional Decline Among Older Adults.,"BACKGROUND


In-hospital immobility of older adults is associated with hospital-associated functional decline (HAFD). This study examined the WALK-FOR program's effects on HAFD prevention.
METHODS


A quasi-experimental pre-post two-group (intervention group [IG] n = 188, control group [CG] n = 189) design was applied in two hospital internal medical units. On admission, patients reported pre-hospitalization functional status, which was assessed again at discharge and 1-month follow-up. Primary outcome was decline in basic activities of daily living (BADL), using the Modified Barthel Index. Secondary outcomes were decline in instrumental ADL (Lawton's IADL scale) and community mobility (Yale Physical Activity Survey). All participants (75.1 ± 7 years old) were cognitively intact and ambulatory at admission. The WALK-FOR included a unit-tailored mobility program utilizing patient-and-staff education with a specific mobility goal (900 steps per day), measured by accelerometer.
RESULTS


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = .02) at discharge, and among 43% of the CG versus 30% in the IG (p = .01) at 1-month follow-up. Similarly, 26% of the CG versus 15% of the IG declined in community mobility at 1-month follow-up (p = .01). Adjusted for major covariates, the intervention reduced the odds of decline in BADL by 41% (p = .05) at discharge and by 49% at 1-month follow-up (p = .01), and in community mobility by 63% (p = .02). There was no significant effect of the intervention on IADL decline (p = .19).
CONCLUSIONS


The WALK-FOR intervention is effective in reducing HAFD.",2019,"Results


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = 0.02) at discharge, and among 43% of the CG versus 30% in the IG (p = 0.01) at 1-month follow-up.","['188, control group [CG] n\xa0', 'All participants (75.1\xa0±\xa07 years old) were cognitively intact and ambulatory at admission', 'older adults']","['WALK-FOR intervention', 'Methods\n\n\nA quasi-experimental pre-post two-group (intervention group [IG] n\xa0', 'WALK-FOR']","['community mobility', 'decline in basic activities of daily living (BADL), using the Modified Barthel Index (MBI', 'BADL', 'IADL decline', ""decline in instrumental ADL (Lawton's IADL scale) and community mobility (Yale Physical Activity Survey""]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0233814,"Results


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = 0.02) at discharge, and among 43% of the CG versus 30% in the IG (p = 0.01) at 1-month follow-up.","[{'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Department of Gerontology, Faculty of Social Welfare and Health Sciences, University of Haifa, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zisberg', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Yehudit', 'Initials': 'Y', 'LastName': 'Chayat', 'Affiliation': 'HaEmek Medical Center, Clalit Health Services, Afula, Israel.'}, {'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Gur-Yaish', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Gil', 'Affiliation': 'Clalit Health Services, Haifa and West Galilee and Carmel Hospital, Israel.'}, {'ForeName': 'Chedva', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rand', 'Affiliation': 'Department of Occupational Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Agmon', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz025']
1754,31369655,Ecopipam as a pharmacologic treatment of stuttering.,"BACKGROUND


Stuttering, also known as childhood-onset fluency disorder, is a chronic neurodevelopmental disorder that affects 1% of the population and can greatly impact an individual's social, occupational, and academic functioning. Prior research has shown dopamine D2 antagonists are effective in reducing the severity of stuttering symptoms, but these compounds can be associated with metabolic and movement disorder adverse effects. Ecopipam is an investigational medication that acts as a selective dopamine D1 receptor antagonist. This mechanism should reduce the likelihood of metabolic and movement disorder adverse effects of D2 antagonists.
METHOD


This open-label pilot study investigated ecopipam in the treatment of adults who stutter.
RESULTS


The results showed that a majority of participants demonstrated improvement in their stuttering. The medication was well tolerated.
CONCLUSIONS


These positive, preliminary findings suggest that a doubleblind, randomized controlled clinical trial to examine the efficacy of ecopipam in the treatment of stuttering is warranted.",2019,The results showed that a majority of participants demonstrated improvement in their stuttering.,['adults who stutter'],[],['tolerated'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]",[],[],,0.0268101,The results showed that a majority of participants demonstrated improvement in their stuttering.,"[{'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Maguire', 'Affiliation': 'Professor and Chair of Psychiatry and Neuroscience, University of California, Riverside, School of Medicine, CA 92521 USA. E-MAIL: gerald.maguire@medsch.ucr.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'LaSalle', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoffmeyer', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Jeannie D', 'Initials': 'JD', 'LastName': 'Lochhead', 'Affiliation': ''}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Burris', 'Affiliation': ''}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Yaruss', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
1755,30655451,Sertraline or placebo in chronic breathlessness? Lessons from placebo research.,,2019,,[],"['Sertraline or placebo', 'placebo']",[],[],"[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.21493,,"[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Pattinson', 'Affiliation': 'Nuffield Dept of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vishvarani', 'Initials': 'V', 'LastName': 'Wanigasekera', 'Affiliation': 'Nuffield Dept of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",The European respiratory journal,['10.1183/13993003.02225-2018']
1756,32429977,The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial.,"BACKGROUND


Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women.
METHODS


This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention.
RESULTS


The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001).
CONCLUSION


The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.
TRIAL REGISTRATION


IRCT20160602028220N2.",2020,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","['96 postmenopausal women who suffered from vaginal atrophy', 'women who have a contraindication for hormone therapy is recommended', 'The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH\u2009>\u200940\u2009IU, monogamous women with the sexual relationship', 'postmenopausal women', 'postmenopausal women are suffering from vaginal atrophy']","['placebo', 'oxytocin vaginal gel', 'oxytocin', 'oxytocin gel per night and women in the placebo']","['maturation index', 'vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina', 'vaginal atrophy', 'severe symptoms of vaginal atrophy', 'number of superficial cells', 'number of parabasal cells', 'subjective symptoms of vaginal atrophy, vaginal PH, maturation index', 'PH of the vagina']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425932', 'cui_str': 'Date of last menstrual period'}, {'cui': 'C0558125', 'cui_str': 'Monogamous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]",96.0,0.337173,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","[{'ForeName': 'Ilnaz', 'Initials': 'I', 'LastName': 'Zohrabi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran. parvinabdei@ymail.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shakiba Maram', 'Affiliation': 'Pharmaceutics Department, Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Houshmand', 'Affiliation': 'Department of Pharmacology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}]",BMC women's health,['10.1186/s12905-020-00935-5']
1757,32429983,Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.,"BACKGROUND


'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence.
METHODS


First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness.
RESULTS


We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
CONCLUSIONS


Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.",2020,"After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
",[],['HCPs'],[],[],[],[],47.0,0.0559924,"After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Riordan', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland. fiona.riordan@ucc.ie.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Eunice T', 'Initials': 'ET', 'LastName': 'Phillip', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'Department of General Practice, University College Cork, Cork, Ireland.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Lorencatto', 'Affiliation': 'Centre for Behaviour Change, University College London, London, England.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Department of Economics, Cork University Business School, University College Cork, Cork, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Sheena M', 'Initials': 'SM', 'LastName': 'McHugh', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}]",Implementation science : IS,['10.1186/s13012-020-00982-4']
1758,32430047,"Confidence, attitudes, beliefs and determinants of implementation behaviours among physiotherapists towards clinical management of low back pain before and after implementation of the BetterBack model of care.","BACKGROUND


Implementing clinical guidelines is challenging. To facilitate uptake, we developed a model of care (BetterBack Model of Care) and an implementation strategy to support management of low back pain in primary care. The aim of this study was to evaluate physiotherapists´ confidence, attitudes and beliefs in managing patients with low back pain before and after a multifaceted implementation of the BetterBack Model of Care. A further aim was to evaluate determinants of implementation behaviours among physiotherapists.
METHODS


This clinical trial was an experimental before and after study within a hybrid type 2 effectiveness-implementation trial. The primary outcome was Practitioner Self-Confidence Scale (PCS), secondary outcomes were the Pain Attitude and Beliefs Scale for Physiotherapists (PABS-PT) and Determinants of Implementation Behaviour Questionnaire (DIBQ). Data was analysed using repeated measures ANOVA and pairwise comparisons.
RESULTS


One hundred sixteen physiotherapists answered a questionnaire before, directly after, as well as 3 and 12 months after implementation of the Model of Care. PCS improved over time with a large effect size post implementation (η p 2  = 0.197, p < 0.001). Changes in PABS-PT were only significant after 12 months with higher biopsychosocial orientation, (η p 2  = 0.071, p < 0.01) and lower biomedical orientation, (η p 2  = 0.136, p < 0.001). Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation. However, after 3 months, all domains had significantly decreased except for organisation, social influence and patient expectation domains. However, after 12 months, organisation and social influence domains had significantly decreased while domains such as knowledge, skills and beliefs about capabilities returned to initial levels.
CONCLUSIONS


Physiotherapists´ confidence and biopsychosocial orientation increased after implementation and may have the potential to improve management of low back pain in primary care. The implementation behaviour showed mostly facilitating patterns but changed over time, pinpointing a need to repeatedly monitor these changes. This can inform the need for changes of implementation efforts in different phases and support sustainability strategies.
TRAIL REGISTRATION


ClinicalTrials.gov NCT03147300 3 May 2017, prospectivly registered.",2020,"Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation.","['low back pain in primary care', 'One hundred sixteen physiotherapists', 'managing patients with low back pain before and after a multifaceted implementation of the BetterBack Model of Care', 'Physiotherapists']",['PCS'],"['Confidence, attitudes, beliefs and determinants of implementation behaviours', 'organisation and social influence domains', 'knowledge, skills and beliefs about capabilities returned to initial levels', 'confidence and biopsychosocial orientation', 'Practitioner Self-Confidence Scale (PCS), secondary outcomes were the Pain Attitude and Beliefs Scale for Physiotherapists (PABS-PT) and Determinants of Implementation Behaviour Questionnaire (DIBQ', 'organisation, social influence and patient expectation domains']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.0878517,"Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schröder', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden. karin.schroder@liu.se.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kongsted', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbott', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}]",BMC health services research,['10.1186/s12913-020-05197-3']
1759,32429965,Evaluation of integrated modular teaching in Chinese ophthalmology trainee courses.,"BACKGROUND


Before attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre, the medical students from Sun Yat-sen University had finished two years of premedical education after the six-year medical courses including basic medical courses, clinical medical courses, clerkship, and research training in medical college. Integrated modular teaching using different problem-based teaching methods in ophthalmology was designed by the teaching steering committee of Zhongshan Ophthalmic Centre. This study aimed to evaluate the effectiveness and satisfaction scales of the integrated modular teaching among the trainee students.
METHODS


A total of 100 medical students attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre were enrolled and randomly allocated into 4 groups according to the teaching arrangement. The trainee courses consisted of several sessions delivered in multiple methods, such as ""flipped classroom"" session and team-based learning session. The pre- and post-class tests were delivered to evaluate the effectiveness of the integrated modular teaching. The satisfaction survey questionnaire was collected from all participants to investigate the degree of satisfaction.
RESULTS


Compared with the first-day-test score, the total last-day-test score was significantly improved by a paired t-test (t = 3.288, P = 0.001). Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654). According to the participant satisfaction questionnaires, these innovative teaching methods were considered as effective and satisfactory.
CONCLUSIONS


Integrated modular teaching in ophthalmology trainee courses is effective and appreciated by the medical college students.",2020,"Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654).","['trainee students', 'Before attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre, the medical students from Sun Yat-sen University had finished two years of premedical education after the six-year medical courses including basic medical courses, clinical medical courses, clerkship, and research training in medical college', 'Chinese ophthalmology trainee courses', 'medical college students', '100 medical students attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre']","['integrated modular teaching', 'several sessions delivered in multiple methods, such as ""flipped classroom"" session and team-based learning session']","['satisfaction survey questionnaire', 'total last-day-test score', 'effectiveness and satisfaction scales']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013646', 'cui_str': 'Premedical Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.0257951,"Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ao', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zheqian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Miaoling', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yangfan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China. yangyangfan@gzzoc.com.""}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China. haot.lin@hotmail.com.""}]",BMC medical education,['10.1186/s12909-020-02073-w']
1760,32430078,"Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial.","BACKGROUND


Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI.
METHODS/DESIGN


This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks' intervention.
DISCUSSION


Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence.
TRIAL REGISTRATION


This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.",2020,"The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises.","['subjects with a CVI diagnosis', 'subjects with chronic venous disease', 'patients with CVI']","['Supervised exercise protocol', 'supervised exercise program', 'bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises', 'control group (usual care/no intervention']","['changes in calf-muscle endurance and QOL score', 'functional activities and decrease quality of life (QOL', 'changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output', 'calf-muscle endurance']","[{'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.117019,"The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises.","[{'ForeName': 'Esther Fernandes Tinoco', 'Initials': 'EFT', 'LastName': 'Volpe', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Resqueti', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Ana Aline Marcelino', 'Initials': 'AAM', 'LastName': 'da Silva', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Lucien Peroni', 'Initials': 'LP', 'LastName': 'Gualdi', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Guilherme A F', 'Initials': 'GAF', 'LastName': 'Fregonezi', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil. fregonezi.guilherme@gmail.com.'}]",Trials,['10.1186/s13063-020-04314-1']
1761,32429917,Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.,"BACKGROUND


Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP.
METHODS


The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation.
DISCUSSION


The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap.
TRIAL REGISTRATION


Dutch Trial Register ID NL7064, 30th of May, 2018.",2020,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","['adults with a low socioeconomic position', 'The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i', 'adults with a low SEP', 'All participants (target n\xa0=\u20091485) should be Dutch-speaking, aged 45-75\u2009years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets', 'Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods', 'adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk']","['control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods']","['changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake', 'changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction', 'cardiometabolic risk', 'lifestyle behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0039371', 'cui_str': 'Tax'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.122374,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","[{'ForeName': 'Josine M', 'Initials': 'JM', 'LastName': 'Stuber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands. j.stuber@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Femke E', 'Initials': 'FE', 'LastName': 'de Boer', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gillebaart', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein C', 'Initials': 'MC', 'LastName': 'Harbers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel C A', 'Initials': 'MCA', 'LastName': 'Klein', 'Affiliation': 'Social AI group, department of Computer Science, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cédric N H', 'Initials': 'CNH', 'LastName': 'Middel', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tjerk Jan', 'Initials': 'TJ', 'LastName': 'Schuitmaker-Warnaar', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Velema', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), The Hague, The Netherlands.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Vos', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}]",Nutrition journal,['10.1186/s12937-020-00562-8']
1762,31707618,Temperature changes on the root surface during application of warm vertical compaction using three different obturation units.,"This study aimed to determine the temperature increase on the root surface during warm vertical compaction using three different obturation systems. Forty-five human single-rooted premolars were randomly assigned to one of three experimental groups of 15 teeth each for obturation with a System B unit, an Elements Obturation Unit, or a B&L SuperEndo Alpha II unit. All teeth were filled using the continuous wave of condensation technique with a set temperature of 200 °C. The temperature measurements were made with an infrared camera at 3 s (T0) and 1 min (T1) following activation of the heat plugger. T0 ranged between 48.1 and 84 °C depending on the obturation system. The mean value for T0 showed significant differences between various obturation systems (p = 0.001). The temperature increase on the root surface during the application of vertical compaction shows considerable variability depending on the obturation system.",2020,The mean value for T0 showed significant differences between various obturation systems (p = 0.001).,['Forty-five human single-rooted premolars'],[],[],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]",[],[],45.0,0.0161077,The mean value for T0 showed significant differences between various obturation systems (p = 0.001).,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Diegritz', 'Affiliation': 'Department of Conservative Dentistry and Peridontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, 80336, Munich, Germany. diegritz@dent.med.uni-muenchen.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gerlitzki', 'Affiliation': 'Department of Conservative Dentistry and Peridontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, 80336, Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotiadou', 'Affiliation': 'Department of Conservative Dentistry and Peridontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, 80336, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Folwaczny', 'Affiliation': 'Department of Conservative Dentistry and Peridontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, 80336, Munich, Germany.'}]",Odontology,['10.1007/s10266-019-00472-0']
1763,32128848,The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.,"BACKGROUND


In vivo studies show that cannabidiol (CBD) acutely reduces blood pressure (BP) in men. The aim of this study was to assess the effects of repeated CBD dosing on haemodynamics.
METHODS


Twenty-six healthy males were given CBD (600 mg) or placebo orally for seven days in a randomised, placebo-controlled, double-blind, parallel study (n = 13/group). Cardiovascular parameters were assessed at rest and in response to isometric exercise after acute and repeated dosing using Finometer®, Vicorder® and Duplex ultrasound.
RESULTS


Compared to placebo, CBD significantly reduced resting mean arterial pressure (P = .04, two-way ANOVA, mean difference (MD) -2 mmHg, 95% CI -3.6 to -0.3) after acute dosing, but not after repeated dosing. In response to stress, volunteers who had taken CBD had lower systolic BP after acute (P = .001, two-way ANOVA, MD -6 mmHg, 95% CI -10 to -1) and repeated (P = .02, two-way ANOVA, MD -5.7 mmHg, 95% CI -10 to -1) dosing. Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01). Within the CBD group, repeated dosing reduced arterial stiffness by day 7 (pulse wave velocity; MD -0.44 m/s, P = .05) and improved endothelial function (flow mediation dilatation, MD +3.5%, P = .02, n = 6 per group), compared to day 1.
CONCLUSION


CBD reduces BP at rest after a single dose but the effect is lost after seven days of treatment (tolerance); however, BP reduction during stress persists. The reduction in arterial stiffness and improvements in endothelial function after repeated CBD dosing are findings that warrant further investigation in populations with vascular diseases.",2020,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","['Twenty-six healthy males', 'healthy men', 'men']","['placebo', 'CBD', 'placebo, CBD', 'cannabidiol (CBD']","['Cardiovascular parameters', 'BP reduction', 'systolic BP', 'blood pressure (BP', 'arterial stiffness', 'resting mean arterial pressure', 'internal carotid artery diameter', 'endothelial function']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",26.0,0.459438,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","[{'ForeName': 'Salahaden R', 'Initials': 'SR', 'LastName': 'Sultan', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14225']
1764,31559961,The OVIVA trial.,,2019,,[],[],[],[],[],[],,0.0460306,,"[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Bejon', 'Affiliation': 'Kenya Medical Research Institute, Kilifi, PO Box 230, Kenya. Electronic address: pbejon@kemri-wellcome.org.'}, {'ForeName': 'Ho Kwong', 'Initials': 'HK', 'LastName': 'Li', 'Affiliation': 'Oxford University Hospitals NHS Trust, Oxford, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Rombach', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scarborough', 'Affiliation': 'Oxford University Hospitals NHS Trust, Oxford, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30482-7']
1765,31714608,Improving timely access to food allergy care: A pragmatic controlled trial.,,2020,,[],[],[],[],[],[],,0.0896965,,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stival', 'Affiliation': ""Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Peat', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Molloy', 'Affiliation': ""Population Allergy, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Sharoan', 'Initials': 'S', 'LastName': 'Selvakumaran', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Mimi L K', 'Initials': 'MLK', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}]",Allergy,['10.1111/all.14105']
1766,32129558,Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence.,"INTRODUCTION AND AIMS


The Australian Treatment Outcomes Profile (ATOP) was developed as a clinical tool for monitoring the substance use, health and wellbeing of clients in alcohol and other drug treatment. This is the first psychometric validation of the ATOP in a cannabis-dependent treatment population.
DESIGN AND METHODS


A total of 128 individuals with cannabis dependence enrolled in an outpatient randomised controlled trial were administered the ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline. Concurrent validity was assessed by testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS). Interrater reliability was tested by comparing clinician-administered ATOP items at the medical screening interview to the same ATOP items administered by researchers at baseline.
RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67). The ATOP Quality of Life scale showed moderate agreement with the SDS and six-dimensional health state short form scales (r = 0.38-0.40). ATOP substance use, employment, education and child care items showed good to excellent interrater reliability (Krippendorff's α = 0.62-0.81), and tobacco use, Psychological Health, Physical Health and Quality of Life showed fair to moderate interrater reliability (Krippendorff's α = 0.42-0.53).
DISCUSSION AND CONCLUSIONS


The ATOP appears to be valid and reliable when tested in a population with cannabis-dependence, justifying its widespread use in clinical settings.",2020,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","['128 individuals with cannabis dependence enrolled', 'clients with cannabis dependence']",['ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline'],"['tobacco use, Psychological Health, Physical Health and Quality of Life', 'ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores', 'SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores', 'testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS', 'substance use, health and wellbeing of clients in alcohol', 'ATOP Quality of Life scale', 'Interrater reliability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",128.0,0.0326362,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","[{'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Discipline of Addiction Medicine, Faculty Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Deacon', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'Mind and Neuroscience Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Mammen', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}]",Drug and alcohol review,['10.1111/dar.13050']
1767,32428059,Effect of violet LED light on in-office bleaching protocols: a randomized controlled clinical trial.,"Objective This study evaluated the clinical effect of violet LED light on in-office bleaching used alone or combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP). Methodology A total of 100 patients were divided into five groups (n=20): LED, LED/CP, CP, LED/HP and HP. Colorimetric evaluation was performed using a spectrophotometer (ΔE, ΔL, Δa, Δb) and a visual shade guide (ΔSGU). Calcium (Ca)/phosphorous (P) ratio was quantified in the enamel microbiopsies. Measurements were performed at baseline (T 0 ), after bleaching (T B ) and in the 14-day follow-up (T 14 ). At each bleaching session, a visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS). Data were evaluated by one-way (ΔE, Δa, ΔL, Δb), two-way repeated measures ANOVA (Ca/P ratio), and Tukey post-hoc tests. ΔSGU and TS were evaluated by Kruskal-Wallis and Mann-Whitney, and AR by Chi-Squared tests (a=5%). Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05). No differences were observed in ΔE and ΔSGU for LED/CP and HP groups (p>0.05). ΔL and Δa were not influenced by LED activation. After bleaching, LED/CP exhibited greater Δb than CP (p>0.05), but no differences were found between these groups at T 14 (p>0.05). LED treatment promoted the lowest risk of TS (16%), while HP promoted the highest (94.4%) (p<0.05). No statistical differences of risk of TS were found for CP (44%), LED/CP (61%) and LED/HP (88%) groups (p>0.05). No differences were found in enamel Ca/P ratio among treatments, regardless of evaluation times. Conclusions Violet LED alone produced the lowest bleaching effect, but enhanced HP bleaching results. Patients treated with LED/CP reached the same efficacy of HP, with reduced risk and intensity of tooth sensitivity and none of the bleaching protocols adversely affected enamel mineral content.",2020,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).",['100 patients were divided into five groups (n=20'],"['LED/CP', 'LED, LED/CP, CP, LED/HP and HP', 'combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP', 'violet LED light']","['risk of TS', 'enamel mineral content', 'lowest risk of TS', 'Calcium (Ca)/phosphorous (P) ratio', 'enamel Ca/P ratio', 'visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS', 'efficacy of HP, with reduced risk and intensity of tooth sensitivity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]",100.0,0.02735,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Kury', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Erica Eiko', 'Initials': 'EE', 'LastName': 'Wada', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Daylana Pacheco da', 'Initials': 'DPD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Cínthia Pereira Machado', 'Initials': 'CPM', 'LastName': 'Tabchoury', 'Affiliation': 'Departamento de Ciências Fisiológicas, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Giannini', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Cavalli', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0720']
1768,32427935,"Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study.","Intradialytic exercise (ID) programs are effective and safe for hemodialysis (HD) patients to avoid functional deterioration. However, exercise is not routinely undertaken in most HD units, and we do not know if home-based (HB) programs are as effective as ID programs. The purpose of this study was to compare the effects of 16 weeks of ID exercise versus a HB exercise program for HD patients. A total of 46 patients were randomly assigned to the ID group (n = 24) or HB group (n = 22). They completed a 16-week combined exercise program 3 times/week. We measured physical activity level, physical functioning, depression level, and health-related quality of life at baseline and after 16 weeks. A significant time effect was found in both groups for the physical activity level (p = 0.012). There was also a significant group-time interaction effect for the one-leg standing test (OLST) (p = 0.049) and a significant time effect for the Short Physical Performance Battery (p = 0.013), timed up-and-go test (p = 0.005), sit-to-stand-10 (p = 0.027), right and left hand handgrip (p = 0.044, p < 0.001), one-heel left leg raise (p = 0.019), and 6-minute walking (p = 0.006), depression (p = 0.017). HRQoL remained unchanged. There was no difference between the two interventions on the tested outcomes (besides OLST). Both interventions were associated with positive changes of the physical activity levels and physical function.",2020,A significant time effect was found in both groups for the physical activity level (p = 0.012).,"['HD patients', '46 patients']","['Intradialytic exercise (ID) programs', 'HB', 'intradialytic versus home-based exercise programs', 'HB exercise program', 'ID exercise']","['time interaction effect', 'physical activity levels and physical function', 'physical functioning, physical activity level, adherence, and health-related quality of life', 'physical activity level, physical functioning, depression level, and health-related quality of life', 'one-heel left leg raise', 'HRQoL', 'Short Physical Performance Battery', 'leg standing test (OLST', 'depression', 'physical activity level', 'sit-to-stand-10', '6-minute walking']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0439232', 'cui_str': 'min'}]",46.0,0.0293592,A significant time effect was found in both groups for the physical activity level (p = 0.012).,"[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortega-Pérez de Villar', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. lucia.ortega@universidadeuropea.es.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Martínez-Olmos', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco de Borja', 'Initials': 'FB', 'LastName': 'Pérez-Domínguez', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Benavent-Caballer', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Montañez-Aguilera', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mercer', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research School of Health Sciences, Queen Margaret University, Musselburgh, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segura-Ortí', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}]",Scientific reports,['10.1038/s41598-020-64372-y']
1769,31324126,Use of eggshell-derived nano-hydroxyapatite as novel bone graft substitute-A randomized controlled clinical study.,,2019,,[],['eggshell-derived nano-hydroxyapatite'],[],[],"[{'cui': 'C4521537', 'cui_str': 'Eggshell'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}]",[],,0.0540946,,"[{'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Kattimani', 'Affiliation': '1 Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Krishna Prasad', 'Initials': 'KP', 'LastName': 'Lingamaneni', 'Affiliation': '1 Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Samatha', 'Initials': 'S', 'LastName': 'Yalamanchili', 'Affiliation': '2 Department of Oral Medicine and Radiology, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Mupparapu', 'Affiliation': '3 Department of Oral Medicine, University of Pennsylvania School of Dental Medicine, Philadelphia, PA, USA.'}]",Journal of biomaterials applications,['10.1177/0885328219863311']
1770,19732072,Migraines with and without aura and their response to preventive therapy with topiramate.,"Data from the Prolonged Migraine Prevention (PROMPT) with Topiramate trial were evaluated post hoc to determine whether topiramate could prevent migraine auras, and whether its efficacy in preventing migraine headaches was similar in patients with (MA; n = 269) and without (MoA; n = 542) aura. Migraines and auras were recorded during prospective baseline, 6-month open-label (OL) topiramate and 6-month double-blind (DB), placebo-controlled phases. In the last 28 OL days, migraines without aura and migraine auras decreased by 43.1% and 54.1%, respectively, in MA patients. MoA patients experienced a 44.3% reduction in migraines. In the DB phase, increases in migraines with placebo vs. topiramate were similar to the full study, but were generally not statistically significant, probably due to lack of power in the subgroup analysis. Similarly, there were no statistically significant changes in number of auras between groups. Thus, topiramate appears to reduce migraine auras in parallel with headache reductions, which are similar in patients with and without aura.",2010,"Similarly, there were no statistically significant changes in number of auras between groups.",['patients with (MA; n = 269) and without (MoA; n = 542) aura'],"['placebo vs. topiramate', 'topiramate', 'open-label (OL) topiramate and 6-month double-blind (DB), placebo-controlled phases']","['migraine headaches', 'number of auras', 'migraines', 'migraines without aura and migraine auras', 'migraine auras']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236018', 'cui_str': 'Aura'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}]",542.0,0.0684186,"Similarly, there were no statistically significant changes in number of auras between groups.","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin, Berlin, Germany. uwe.reuter@charite.de'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanchez Del Rio', 'Affiliation': ''}, {'ForeName': 'H-C', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Allais', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gendolla', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pfeil', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwalen', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Schäuble', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Oene', 'Affiliation': ''}]",Cephalalgia : an international journal of headache,['10.1111/j.1468-2982.2009.01999.x']
1771,19443659,"Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network.","Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation. Corticosteroids remain the standard initial therapy, yet only 25% to 41% of patients completely respond. This randomized, 4-arm, phase 2 trial was designed to identify the most promising agent(s) for initial therapy for aGVHD. Patients were randomized to receive methylprednisolone 2 mg/kg per day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin), or pentostatin. Patients (n = 180) were randomized; their median age was 50 years (range, 7.5-70 years). Myeloablative conditioning represented 66% of transplants. Grafts were peripheral blood (61%), bone marrow (25%), or umbilical cord blood (14%); 53% were from unrelated donors. Patients who received MMF for prophylaxis (24%) were randomized to a non-MMF arm. At randomization, aGVHD was grade I to II (68%), III to IV (32%), and (53%) had visceral organ involvement. Day 28 complete response rates were etanercept 26%, MMF 60%, denileukin 53%, and pentostatin 38%. Corresponding 9-month overall survival was 47%, 64%, 49%, and 47%, respectively. Cumulative incidences of severe infections were as follows: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%. Efficacy and toxicity data suggest the use of MMF plus corticosteroids is the most promising regimen to compare against corticosteroids alone in a definitive phase 3 trial. This study is registered at http://www.clinicaltrials.gov as NCT00224874.",2009,"Cumulative incidences of severe infections were as follows: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%.","['acute graft-versus-host disease', 'Patients (n = 180) were randomized; their median age was 50 years (range, 7.5-70 years']","['MMF plus corticosteroids', 'MMF', 'Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids', 'methylprednisolone 2 mg/kg per day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin), or pentostatin', 'Acute graft-versus-host disease (aGVHD']","['Efficacy and toxicity', 'response rates', 'overall survival', 'umbilical cord blood', 'Cumulative incidences of severe infections', 'visceral organ involvement']","[{'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0030896', 'cui_str': 'Pentostatin'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0987811', 'cui_str': 'Methylprednisolone 2 MG'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0717670', 'cui_str': 'denileukin diftitox'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]",180.0,0.191305,"Cumulative incidences of severe infections were as follows: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%.","[{'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. aalousi@mdanderson.org'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Difronzo', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pasquini', 'Affiliation': ''}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Vincent T', 'Initials': 'VT', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hayes-Lattin', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': ''}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,['10.1182/blood-2009-03-212290']
1772,32430775,"Comparison of clinical efficacy and patient acceptance of interdental brush and silicone coated interdental pick: a randomized split-mouth, prospective clinical trial.","OBJECTIVES


The aim of this split-mouth, prospective controlled study was to compare the effects of two different interdental devices on clinical plaque elimination, gingival bleeding and patient acceptance and comfort.
MATERIALS AND METHODS


Thirty participants who had been diagnosed with gingivitis were included in the study. After professional oral prophylaxis and a 3-day washout period, patients were advised to use two test devices (TePe Interdental Brushes Original and TePe EasyPick™, Malmö, Sweden) according to instructions. The plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index) were recorded at baseline and after 2 weeks. Patient satisfaction and comfort were assessed with a questionnaire.
RESULTS


Both of the tested devices improved the plaque and bleeding index scores. There were no differences between the two sides in terms of time-dependent changes. The patients felt more satisfied with the cleansing capacity and more comfortable with the use of SCIP compared with IDB (p = 0.001). Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
CONCLUSION


The clinical efficiency of the tested interdental devices was similar in terms of removing plaque and decreasing bleeding. However, SCIP were found to be more comfortable and preferable to IDB.
CLINICAL RELEVANCE


The silicone coated interdental picks showed similar effects on plaque removal as interdental brushes and superiority in terms of ease to use than interdental brushes.",2020,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
",['Thirty participants who had been diagnosed with gingivitis were included in the study'],['interdental brush and silicone coated interdental pick'],"['plaque and bleeding index scores', 'clinical plaque elimination, gingival bleeding and patient acceptance and comfort', 'plaque removal', 'plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index', 'Pain sensation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",30.0,0.0542861,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ercan', 'Affiliation': 'Department of Periodontology, Çanakkale Onsekiz Mart University, Çanakkale, Turkey. esraercan82@gmail.com.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03293-6']
1773,32050864,Randomized trial to assess safety/feasibility of memantine administration during residential treatment for alcohol use disorder: a pilot study.,"The  N -methyl- D -aspartate receptor (NMDAr) system is critically involved in the pathogenesis and neurobehavioral sequelae of alcohol use disorder (AUD), and constitutes a potential pharmacotherapeutic target. Memantine (Namenda) is an FDA-approved NMDAr antagonist with suggested utility in AUD, however its safety and tolerability during long-term administration among recently-detoxified patients remains uncharacterized. This pilot study assessed safety, feasibility, and several secondary measures of interest, during a 4-week period of residential AUD treatment. Participants ( N  = 18) met diagnostic criteria for AUD. A double-blind, placebo-controlled, escalating-dose design was utilized. Assessments of medication side-effects were conducted weekly. At intake, week 2, and study completion, participants completed a battery assessing affective symptomatology, craving, and neurocognitive function. Medication groups reported equivalent side effects and severity. Medication compliance was high, and did not differ by group. No memantine effects were observed in secondary outcome measures. Memantine maintains a profile of high tolerability and low side-effects during post-detoxification AUD treatment. These data suggest a more aggressive dosing/escalation schedule may be used safely in future trials designed to ascertain improvements in neurocognitive function, affect, and/or craving as primary measures.",2020,Medication groups reported equivalent side effects and severity.,"['alcohol use disorder', 'Participants ( N \u2009=\u200918) met diagnostic criteria for AUD']","['placebo', 'memantine', 'Memantine', 'Memantine (Namenda']","['safety and tolerability', 'equivalent side effects and severity', 'Medication compliance', 'battery assessing affective symptomatology, craving, and neurocognitive function']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1330412', 'cui_str': 'Namenda'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3489773', 'cui_str': 'Medication Non-Compliance'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0868684,Medication groups reported equivalent side effects and severity.,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greene', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1721404']
1774,32098633,Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial.,"BACKGROUND


Responding to intimate partner violence (IPV) and its consequences is made complex by women's diverse needs, priorities and contexts. Tailored online IPV interventions that account for differences among women have potential to reduce barriers to support and improve key outcomes.
METHODS


Double blind randomized controlled trial of 462 Canadian adult women who experienced recent IPV randomly were assigned to receive either a tailored, interactive online safety and health intervention (iCAN Plan 4 Safety) or a static, non-tailored version of this tool. Primary (depressive symptoms, PTSD symptoms) and secondary (helpfulness of safety actions, confidence in safety planning, mastery, social support, experiences of coercive control, and decisional conflict) outcomes were measured at baseline and 3, 6, and 12 months later via online surveys. Generalized Estimating Equations were used to test for differences in outcomes by study arm. Differential effects of the tailored intervention for 4 strata of women were examined using effect sizes. Exit survey process evaluation data were analyzed using descriptive statistics, t-tests and conventional content analysis.
RESULTS


Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes. Changes over time did not differ by study arm. Women in both groups reported high levels of benefit, safety and accessibility of the online interventions, with low risk of harm, although those completing the tailored intervention were more positive about fit and helpfulness. Importantly, the tailored intervention had greater positive effects for 4 groups of women, those: with children under 18 living at home; reporting more severe violence; living in medium-sized and large urban centers; and not living with a partner.
CONCLUSION


This trial extends evidence about the effectiveness of online safety and health interventions for women experiencing IPV to Canadian women and provides a contextualized understanding about intervention processes and effects useful for future refinement and scale up. The differential effects of the tailored intervention found for specific subgroups support the importance of attending to diverse contexts and needs. iCAN is a promising intervention that can complement resources available to Canadian women experiencing IPV.
TRIAL REGISTRATION


Clinicaltrials.gov ID NCT02258841 (Prospectively Registered on Oct 2, 2014).",2020,"RESULTS


Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes.","['Canadian women experiencing IPV', 'women experiencing IPV to Canadian women', '462 Canadian adult women who experienced recent IPV randomly', 'women experiencing intimate partner violence']","['health intervention', 'interactive online safety and health intervention (iCAN Plan 4 Safety) or a static, non-tailored version of this tool', 'iCAN']","['PTSD', 'Primary (depressive symptoms, PTSD symptoms) and secondary (helpfulness of safety actions, confidence in safety planning, mastery, social support, experiences of coercive control, and decisional conflict) outcomes', 'depression']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0037438'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",462.0,0.249438,"RESULTS


Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes.","[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Ford-Gilboe', 'Affiliation': 'Arthur Labatt Family School of Nursing, University of Western Ontario, FNB 2302, 1151 Richmond St, London, ON, N6A 5C1, Canada. mfordg@uwo.ca.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Varcoe', 'Affiliation': 'School of Nursing, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Scott-Storey', 'Affiliation': 'Faculty of Nursing, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wuest', 'Affiliation': 'Faculty of Nursing, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'C Nadine', 'Initials': 'CN', 'LastName': 'Wathen', 'Affiliation': 'Faculty of Information and Media Studies, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-020-8152-8']
1775,31764701,"The Use of Botulinum Toxin Type A in the Healing of Thyroidectomy Wounds: A Randomized, Prospective, Placebo-Controlled Study.",,2019,,[],"['Placebo', 'Botulinum Toxin Type A']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]",[],,0.0228706,,"[{'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""16th Department, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006252']
1776,31800999,Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins. Reply.,,2019,,[],[],[],[],[],[],,0.0580486,,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brittenden', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom julie.brittenden@glasgow.ac.uk.'}]",The New England journal of medicine,['10.1056/NEJMc1914045']
1777,29757433,The Effects of Useful Field of View Training on Brain Activity and Connectivity.,"OBJECTIVES


Useful Field of View training (UFOVt) is an adaptive computerized cognitive intervention that improves visual attention and transfers to maintained health and everyday functioning in older adults. Although its efficacy is well established, the neural mechanisms underlying this intervention are unknown. This pilot study used functional MRI (fMRI) to explore neural changes following UFOVt.
METHOD


Task-driven and resting-state fMRI were used to examine changes in brain activity and connectivity in healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10).
RESULTS


UFOVt resulted in reduced task-driven activity in the majority of regions of interest (ROIs) associated with task performance, CSA resulted in reduced activity in one ROI, and there were no changes within the NC group. Relative to NC, UFOVt reduced activity in ROIs involved in effortful information processing. There were no other significant between-group task-based differences. Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
DISCUSSION


UFOVt enhances connections needed for visual attention. Together with prior work, this study provides evidence that improvement of the brain's visual attention efficiency is one mechanism underlying UFOVt.",2019,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
","['healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10', 'older adults']","['functional MRI (fMRI', 'View Training', 'View training (UFOVt', 'Method\n\n\nTask-driven and resting-state fMRI']","['executive function and visual attention', 'Brain Activity and Connectivity', 'brain activity and connectivity', 'reduced task-driven activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",13.0,0.0373196,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
","[{'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': 'Department of Human Development and Family Studies, University Park.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Whitaker', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Hicks', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham.'}, {'ForeName': 'Shaadee', 'Initials': 'S', 'LastName': 'Samimy', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dennis', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Visscher', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby041']
1778,31866194,The impact of residents sitting at the bedside on patient satisfaction during team rounds.,"OBJECTIVES


Patient satisfaction ratings are a priority for academic medical centers. Sitting during patient encounters has been recommended as a ""best practice."" 1  A prior study showed that hospitalists had higher-rated communication skills when sitting compared to standing at the bedside during rounds. 2  It is unclear whether the same is true of resident-led team rounds.
METHODS


We performed a cluster-randomized crossover trial assigning 18 internal medicine residents to sit or stand at the bedside during rounds.
RESULTS


A total of 347 patients were surveyed to assess physician communication skills. Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ. These results differ from prior work that suggests sitting is superior to standing 2-6 .
CONCLUSION


We suspect that one rounding member sitting, while all others stand, is not enough to impact patients' perceptions. These results suggest that initiatives to optimize patient satisfaction on resident-staffed units should be focused elsewhere.
PRACTICE IMPLICATIONS


Patients do not have better impressions of physician communication skills when one team member is sitting and the rest are standing.",2020,Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ.,"['347 patients were surveyed to assess physician communication skills', '18 internal medicine residents to sit or stand at the bedside during rounds']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",[],[],347.0,0.0382242,Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ.,"[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Donovan', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: donovanak2@upmc.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Spagnoletti', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rothenberger', 'Affiliation': 'Institute for Clinical Research Education, Center for Research on Healthcare Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Corbelli', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Patient education and counseling,['10.1016/j.pec.2019.12.013']
1779,32432326,"Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial.","STUDY QUESTION


Are intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC) related to live birth rate in couples with unexplained infertility?
SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
WHAT IS ALREADY KNOWN


We previously determined that some baseline characteristics of couples with unexplained infertility, including female age, duration of infertility, history of prior loss and income, were related to live birth rate across a course of ovarian stimulation and IUI treatment. However, the relationship between treatment outcomes and per-cycle characteristics, including ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC, are controversial, and most prior investigations have not evaluated live birth outcome.
STUDY DESIGN, SIZE, DURATION


This was a secondary analyses of 2462 cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. This prospective, randomised, multicentre clinical trial determined live birth rates following IUI after ovarian stimulation with clomiphene citrate, letrozole or gonadotropins in 854 couples with unexplained infertility. It was conducted between 2011 and 2014, and couples could undergo up to four consecutive treatment cycles.
PARTICIPANTS/MATERIALS, SETTING, METHODS


AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites. Participants were women with unexplained infertility who were between 18 and 40 years of age. Cluster-weighted generalised estimating equations (GEE), which account for informative clustering of multiple IUI treatment cycles within the same patient, were used to determine associations between IUI performance characteristics, including inseminate TMC, and live birth rate. Efficiency curves were also generated to examine the relationship between inseminate TMC and live birth rate.
MAIN RESULTS AND THE ROLE OF CHANCE


After adjustment for treatment group and baseline factors previously associated with live birth across a course of OS-IUI treatment, patient discomfort during the IUI procedure was associated with a reduction in live birth rate (aRR 0.40 (0.16-0.96)). Time from hCG trigger injection to IUI was not significantly associated with outcome. Higher TMC was associated with greater live birth rate (TMC 15.1-20.0 million (14.8%) compared to ≤5 million (5.5%)) (aRR 2.09 (1.31-3.33)). However, live births did occur with TMC ≤ 1 million (5.1%).
LIMITATIONS, REASONS FOR CAUTION


This investigation is a secondary analysis, and AMIGOS was not designed to address the present question. Since timed intercourse was allowed as part of the AMIGOS trial, we cannot rule out the possibility that any given pregnancy resulted from intercourse rather than IUI.
WIDER IMPLICATIONS OF THE FINDINGS


Most factors associated with the performance of IUI were not significantly related to obtaining live birth. Our findings suggest that higher TMC inseminated leads to an increase in live birth rate up to TMC ~20 million. However, there may be no reasonable threshold below which live birth is not possible with IUI.
STUDY FUNDING/COMPETING INTEREST(S)


Funding was received through grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): U10 HD077680, U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10 HD055925. This research was made possible by funding by the American Recovery and Reinvestment Act. Dr Hansen reports grants from NIH/NICHD and Yale University during the conduct of the study, grants from Roche Diagnostics and grants from Ferring International Pharmascience Center US outside the submitted work. Dr Peck reports support from Ferring Pharmaceuticals outside the submitted work. Dr Coward has nothing to disclose. Dr Wild reports grants from NICHD during the conduct of the study. Dr Trussell has nothing to disclose. Dr Krawetz reports grants from NICHD during the conduct of the study, grants from Merck and support from Taylor and Frances and from Springer, outside the submitted work. Dr Diamond reports grants from NIH/NICHD, Yale University, during the conduct of the study and support from Advanced Reproductive Care AbbVie, Bayer and ObsEva, outside the submitted work. Dr Legro reports support from Bayer, Kindex, Odega, Millendo and AbbVie and grants and support from Ferring, outside the submitted work. Dr Coutifaris reports grants from NICHD/NIH and personal fees from American Society for Reproductive Medicine, outside the submitted work. Dr Alvero has nothing to disclose. Dr Robinson reports grants from NIH during the conduct of the study. Dr Casson has nothing to disclose. Dr Christman reports grants from NICHD during the conduct of the study. Dr Santoro reports grants from NIH during the conduct of the study. Dr Zhang reports grants from NIH during the conduct of the study and support from Shangdong University outside the submitted work.
TRIAL REGISTRATION NUMBER


n/a.",2020,"SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
","['Participants were women with unexplained infertility who were between 18 and 40\xa0years of age', 'AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites', '854 couples with unexplained infertility', '2462\xa0cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial', '2011 and 2014, and couples could undergo up to four consecutive treatment cycles', 'couples with unexplained infertility']","['intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC', 'clomiphene citrate, letrozole or gonadotropins', 'Intrauterine insemination performance characteristics and post-processing total motile sperm count']","['live birth across a course of OS-IUI treatment, patient discomfort', 'live birth rate', 'ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0449935', 'cui_str': 'Post-processing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",854.0,0.111279,"SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
","[{'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, UNC School of Medicine, 2113 Physicians Office Building CB#7235, Chapel Hill, NC 27599-7235, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, 750 East Adams Street, Syracuse, NY 13210, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA 17033, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, TX 78229, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, VT 05446, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06520, USA.'}, {'ForeName': 'For The Nichd Reproductive', 'Initials': 'FTNR', 'LastName': 'Medicine Network', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa027']
1780,32429839,Sevoflurane versus PRopofol combined with Remifentanil anesthesia Impact on postoperative Neurologic function in supratentorial Gliomas (SPRING): protocol for a randomized controlled trial.,"BACKGROUND


Patients with intracranial tumors are more sensitive to anesthetics than the general population and are therefore more susceptible to postoperative neurologic and neurocognitive dysfunction. Sevoflurane or propofol combined with remifentanil are widely used general anesthetic regimens for craniotomy, with neither regimen shown to be superior to the other in terms of neuroprotective efficacy and anesthesia quality. There is no evidence regarding the variable effects on postoperative neurologic and neurocognitive functional outcome under these two general anesthetic regimens. This trial will compare inhalational sevoflurane or intravenous propofol combined with remifentanil anesthesia in patients with supratentorial gliomas and test the hypothesis that postoperative neurologic function is equally affected between the two regimens.
METHODS


This is a prospective, single-center, randomized parallel arm equivalent clinical trial, which is approved by China Ethics Committee of Registering Clinical Trials (ChiECRCT-20,160,051). Patients with supratentorial gliomas diagnosed by magnetic resonance imaging will be eligible for the trial. Written informed consent will be obtained before randomly assigning each subject to either the sevoflurane-remifentanil or propofol-remifentanil group for anesthesia maintenance to achieve an equal-desired depth of anesthesia. Intraoperative intervention and monitoring will follow a standard anesthetic management protocol. All of the physiological parameters and other medications administered during the intervention will be recorded. The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4. Secondary outcomes will include NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense.
DISCUSSION


This randomized equivalency trial will primarily compare the impacts of sevoflurane-remifentanil and propofol-remifentanil anesthesia on short-term postoperative neurologic function in patients with supratentorial gliomas undergoing craniotomy. The exclusion criteria are strict to ensure that the groups are comparable in all aspects. Repeated and routine neurologic evaluations after operation are always important to evaluate neurosurgical patients' recovery and any newly presenting complications. The results of this trial would help specifically to interpret anesthetic residual effects on postoperative outcomes, and perhaps would help the anesthesiologist to select the optimal anesthetic regimen to minimize its impact on neurologic function in this specific patient population.
TRIAL REGISTRATION


The study was registered and approved by the Chinese Clinical Trial Registry (Chinese Clinical Trial Registry, ChiCTR-IOR-16009177). Principle investigator: Nan Lin (email address: linnan127@gmail.com) and Ruquan Han (email address: hanrq666@aliyun.com) Date of Registration: September 8th, 2016. Country of recruitment: China.",2020,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"['patients with supratentorial gliomas', 'patients with supratentorial gliomas undergoing craniotomy', 'supratentorial Gliomas (SPRING', 'Patients with supratentorial gliomas diagnosed by', 'Patients with intracranial tumors']","['Intraoperative intervention', 'propofol combined with remifentanil anesthesia', 'hanrq666@aliyun.com', 'Sevoflurane', 'inhalational sevoflurane', 'Remifentanil anesthesia', 'sevoflurane-remifentanil or propofol-remifentanil', 'magnetic resonance imaging', 'sevoflurane-remifentanil and propofol-remifentanil anesthesia', 'Lin (email address: linnan127@gmail.com) and Ruquan Han (email address', 'PRopofol', 'Sevoflurane or propofol combined with remifentanil']","['postoperative Neurologic function', ""neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4\u2009h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4"", 'postoperative neurologic function', 'postoperative neurologic and neurocognitive functional outcome', 'NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0574448', 'cui_str': 'Lingala language'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0641339', 'cui_str': 'hexaaquanickel(II) chlorate'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",,0.123406,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. linnan127@gmail.com.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. Hanrq666@aliyun.com.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bebawy', 'Affiliation': 'Departments of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine, 251 E. Huron St., F5-704, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Manyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Lanyi', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01035-5']
1781,32428865,"Remdesivir in COVID-19: A critical review of pharmacology, pre-clinical and clinical studies.","BACKGROUND & AIMS


Remdesivir is a broad spectrum anti-viral drug that has shown to inhibit SARS-CoV-2, in vitro and in vivo. In absence of any effective treatment for SARS-CoV-2 infection (COVID-19), remdesivir has been tried for a compassionate use in severe COVID-19. Newer randomized controlled studies that have recently become available, showed a mixed result. We aimed to systematically search the literature to understand the pharmacology and clinical effects of remdesivir in patients with COVID-19.
METHODS


We systematically searched the PubMed, ClinicalTrial.Org and MedRxiv database up till May 5, 2020 using specific key words such as ""Remdesivir"" or 'GS-5734″ AND ""COVID-19"" or ""SARS-CoV-2"" and retrieved all the article published in English language, that have reported the pharmacology and the clinical outcomes of remdesivir in patients with COVID-19.
RESULTS


Initial compassionate use of remdesivir has shown a fairly good result, but difficult to quantify, in the absence of control arm. While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
CONCLUSIONS


Remdesivir has shown a mixed result in patients with COVID-19 with an acceptable side effect. However, jury is still out while awaiting the results from the forthcoming trials.",2020,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","['Remdesivir in COVID-19', 'patients with COVID-19']",['placebo'],['mortality'],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.151411,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India. Electronic address: draksingh_2001@yahoo.com.'}, {'ForeName': 'Akriti', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gynaecology & Obstetrics, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Fortis C-DOC Hospital for Diabetes and Allied Sciences, New Delhi, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.018']
1782,32434490,Does growth hormone supplementation improve oocyte competence and IVF outcomes in patients with poor embryonic development? A randomized controlled trial.,"BACKGROUND


Many studies have demonstrated the benefits of the addition of growth hormone (GH) to the controlled ovarian stimulation protocol in vitro fertilization (IVF) cycles in poor-respond patients, but the effect of GH on patients with poor embryonic development remain unclear. This paper was designed to investigate the efficacy of GH co-treatment during IVF for the patients with poor embryonic development.
METHOD


A randomized controlled trial including 158 patients with poor embryo development was conducted between July 2017 and February 2019. One hundred and seven patients were randomized for GH treatment (GH group) and 51 patients for untreated (control group). The primary end-points were the clinical pregnancy and live birth rates in the two groups. The oocyte competence were assessed through calculating the mitochondrial DNA (mtDNA) copy number in corresponding cumulus granulosa cells (CGCs). Quantitative PCR were used for calculation of mtDNA copy number.
RESULTS


Relative to the control group, GH co-treatment resulted in a significantly higher number of retrieved oocytes (10.29 ± 5.92 versus 8.16 ± 4.17, P = 0.023) and cleaved embryos (6.73 ± 4.25 versus 5.29 ± 3.23, P = 0.036). The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006). CGCs of the GH group had significantly higher mtDNA copy numbers than CGCs of the control group (252 versus 204, P < 0.001).
CONCLUSIONS


These data provided further evidence to indicate that GH supplementation may support more live births during IVF, in patients with poor embryonic development. It also appears that oocytes generated under GH co-treatment have a better developmental competence.
TRIAL REGISTRATION


ChiCTR1900021992 posted March 19, 2019 (retrospectively registered).",2020,"The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006).","['158 patients with poor embryo development was conducted between July 2017 and February 2019', 'One hundred and seven patients', 'patients with poor embryonic development']","['growth hormone supplementation', 'GH supplementation', 'GH treatment (GH', 'growth hormone (GH']","['mitochondrial DNA (mtDNA) copy number in corresponding cumulus granulosa cells (CGCs', 'oocyte competence and IVF outcomes', 'clinical pregnancy and live birth rates', 'implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle', 'number of retrieved oocytes', 'cleaved embryos']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",158.0,0.122168,"The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006).","[{'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Guoning', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China. yehong1210@163.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03004-9']
1783,31925817,"First-in-human clinical trial to assess the safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection.","AIMS


This first-in-human clinical trial of P218, a novel dihydrofolate reductase inhibitor antimalarial candidate, assessed safety, tolerability, pharmacokinetics and food effects in healthy subjects.
METHODS


The study consisted of two parts. Part A was a double-blind, randomized, placebo-controlled, parallel group, ascending dose study comprising seven fasted cohorts. Eight subjects/cohort were randomized (3:1) to receive either a single oral dose of P218 (10, 30, 100, 250, 500, 750 and 1000 mg) or placebo. Part B was an open-label, cross-over, fed/fasted cohort (eight subjects) that received a 250 mg single dose of P218 in two treatment periods.
RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects. Nine adverse events in five subjects, all of mild intensity, were judged drug related. No clinically relevant abnormalities in ECG, vital signs or laboratory tests changes were observed. P218 was rapidly absorbed, with C max  achieved between 0.5 and 2 hours post dose. Plasma concentrations declined bi-exponentially with half-life values ranging from 3.1 to 6.7 hours (10 and 30 mg), increasing up to 8.9 to 19.6 hours (doses up to 1000 mg). Exposure values increased dose-proportionally between 100 and 1000 mg for P218 (parent) and three primary metabolites (P218 β-acyl glucuronide, P218-OH and P218-OH β-acyl glucuronide). Co-administration of P218 with food reduced C max  by 35% and delayed absorption by 1 hour, with no significant impact on AUC.
CONCLUSION


P218 displayed favourable safety, tolerability and pharmacokinetics. In view of its short half-life, a long-acting formulation will be needed for malaria chemoprotection.",2020,"RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.",['healthy subjects'],"['placebo', 'Co']","['Plasma concentrations', 'safety, tolerability, pharmacokinetics and food effect', 'delayed absorption', 'safety, tolerability and pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",8.0,0.0945555,"RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.","[{'ForeName': 'M Farouk', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rossignol', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Donini', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'El Gaaloul', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coates', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Langdon', 'Affiliation': 'PTx Solutions, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hammond', 'Affiliation': 'Preclinical Safety Consulting Ltd, Loughborough, Leicestershire, UK.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14219']
1784,32432669,Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial.,"Importance


Factors contributing to underrepresentation of women in surgery are incompletely understood. Pro-male bias and stereotype threat appear to contribute to gender imbalance in surgery.
Objectives


To evaluate the association between pro-male gender bias and career engagement and the effect of stereotype threat on skill performance among trainees in academic surgery.
Design, Setting, and Participants


A 2-phase study with a double-blind, randomized clinical trial component was conducted in 3 academic general surgery training programs. Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year. In phase 1, surveys administered 5 to 6 months apart investigated the association of gender bias with career engagement. In phase 2, residents were randomized 1:1 using permuted-block design stratified by site, training level, and gender to receive either a trigger of or protection against stereotype threat. Immediately after the interventions, residents completed the Fundamentals of Laparoscopic Surgery (FLS) assessment followed by a final survey. A total of 131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1. Eighty-five residents were randomized in phase 2, and 4 residents in each arm were lost to follow-up.
Intervention


Residents read abstracts that either reported that women had worse laparoscopic skill performance than men (trigger of stereotype threat [A]) or had no difference in performance (protection against stereotype threat [B]).
Main Outcomes and Measures


Association between perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2) were the outcomes. Intention-to-treat analysis was conducted.
Results


Seventy-seven residents (38 women [49.4%]) completed both phases of the study. The association between pro-male gender bias and career engagement differed by gender (interaction coefficient, -1.19; 95% CI, -1.90 to -0.49; P = .02); higher perception of bias was associated with higher engagement among men (coefficient, 1.02; 95% CI, 0.19-2.24; P = .04), but no significant association was observed among women (coefficient, -0.25; 95% CI, -1.59 to 1.08; P = .50). There was no evidence of a difference in FLS score between interventions (mean [SD], A: 395 [150] vs B: 367 [157]; P = .51). The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39). The association between stereotype threat activation and FLS score differed by gender across levels of susceptibility to stereotype threat (interaction coefficient, -35.3; 95% CI, -47.0 to -23.6; P = .006). Higher susceptibility to stereotype threat was associated with lower FLS scores among women who received a stereotype threat trigger (coefficient, -43.4; 95% CI, -48.0 to -38.9; P = .001).
Conclusions and Relevance


Perception of pro-male bias and gender stereotypes may influence career engagement and skill performance, respectively, among surgical trainees.
Trial Registration


ClinicalTrials.gov Identifier: NCT03623009.",2020,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","['Results\n\n\nSeventy-seven residents (38 women [49.4%]) completed both phases of the study', '3 academic general surgery training programs', 'Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year', 'Eighty-five residents', '131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1', 'Surgical Training', 'trainees in academic surgery']","['trigger of or protection against stereotype threat', 'stereotype threat']","['perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2', 'stereotype threat activation and FLS score', 'FLS scores', 'performance (protection against stereotype threat [B', 'skill performance', 'FLS score', 'laparoscopic skill performance', 'response to stereotype threat activation']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",131.0,0.222041,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Myers', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Dasari', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Lumpkin', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chaumont', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Downs-Canner', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Meghan R', 'Initials': 'MR', 'LastName': 'Flanagan', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA surgery,['10.1001/jamasurg.2020.1127']
1785,31522849,"Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study.","BACKGROUND


Dietary avoidance is recommended for peanut allergies. We evaluated the sustained effects of peanut allergy oral immunotherapy (OIT) in a randomised long-term study in adults and children.
METHODS


In this randomised, double-blind, placebo-controlled, phase 2 study, we enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants were randomly assigned (2·4:1·4:1) in a two-by-two block design via a computerised system to be built up and maintained on 4000 mg peanut protein through to week 104 then discontinued on peanut (peanut-0 group), to be built up and maintained on 4000 mg peanut protein through to week 104 then to ingest 300 mg peanut protein daily (peanut-300 group) for 52 weeks, or to receive oat flour (placebo group). DBPCFCs to 4000 mg peanut protein were done at baseline and weeks 104, 117, 130, 143, and 156. The pharmacist assigned treatment on the basis of a randomised computer list. Peanut or placebo (oat) flour was administered orally and participants and the study team were masked throughout by use of oat flour that was similar in look and feel to the peanut flour and nose clips, as tolerated, to mask taste. The statistician was also masked. The primary endpoint was the proportion of participants who passed DBPCFCs to a cumulative dose of 4000 mg at both 104 and 117 weeks. The primary efficacy analysis was done in the intention-to-treat population. Safety was assessed in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02103270.
FINDINGS


Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants, who were randomly assigned to the peanut-0 (n=60), peanut-300 (n=35), and placebo groups (n=25). 21 (35%) of peanut-0 group participants and one (4%) placebo group participant passed the 4000 mg challenge at both 104 and 117 weeks (odds ratio [OR] 12·7, 95% CI 1·8-554·8; p=0·0024). Over the entire study, the most common adverse events were mild gastrointestinal symptoms, which were seen in 90 of 120 patients (50/60 in the peanut-0 group, 29/35 in the peanut-300 group, and 11/25 in the placebo group) and skin disorders, which were seen in 50/120 patients (26/60 in the peanut-0 group, 15/35 in the peanut-300 group, and 9/25 in the placebo group). Adverse events decreased over time in all groups. Two participants in the peanut groups had serious adverse events during the 3-year study. In the peanut-0 group, in which eight (13%) of 60 participants passed DBPCFCs at week 156, higher baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses were associated with sustained unresponsiveness. No treatment-related deaths occurred.
INTERPRETATION


Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut. Since baseline blood tests correlated with week 117 treatment outcomes, this study might aid in optimal patient selection for this therapy.
FUNDING


National Institute of Allergy and Infectious Diseases.",2019,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","['enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants', 'adults and children', 'Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants']","['oat flour (placebo', 'oral immunotherapy', 'placebo', 'DBPCFCs', 'Peanut or placebo (oat) flour', 'peanut allergy oral immunotherapy (OIT']","['proportion of participants who passed DBPCFCs', 'Safety', 'Adverse events', 'skin disorders', 'serious adverse events', 'baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0035168'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}]",120.0,0.566722,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","[{'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA; Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Andorf', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Laughlin"", 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shu Chen', 'Initials': 'SC', 'LastName': 'Lyu', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Manohar', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Boyd', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tibshirani', 'Affiliation': 'Department of Biomedical Data Sciences, Stanford University, Stanford, CA, USA; Department of Statistics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Holden', 'Initials': 'H', 'LastName': 'Maecker', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA. Electronic address: knadeau@stanford.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31793-3']
1786,31523888,Supplementing teacher knowledge using web-based Intelligent Tutoring System for the Text Structure Strategy to improve content area reading comprehension with fourth- and fifth-grade struggling readers.,"The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms. The ITSS was designed to teach students how to select and encode strategic memory from expository texts. The system provides modelling, practice, assessment, scaffolding, and feedback to learners on identifying signalling words, summarizing, making inferences, generating elaborations, and monitoring comprehension. A large scale randomized controlled trial was conducted with 130 fourth-grade and 130 fifth-grade classrooms. Students completed GSRT- and researcher-designed measures of reading comprehension at pretest and posttests. An analysis of fourth-grade students using ITSS who scores less than the 25th percentile on the GSRT pretest showed small but meaningful effect sized on the posttests. The fifth-grade students in ITSS, who scored less than the 25% percentile on the GSRT pretest, showed the highest effect sizes (moderate to large effects) on the standardized test scores on the posttests.",2020,The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms.,['130 fourth-grade and 130 fifth-grade classrooms'],['ITSS'],[],"[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}]",[],[],130.0,0.0278654,The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms.,"[{'ForeName': 'Kausalai', 'Initials': 'K', 'LastName': 'Wijekumar', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Educational Psychology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Puiwa', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Educational Psychology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Andrea Lynn', 'Initials': 'AL', 'LastName': 'Beerwinkle', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}, {'ForeName': 'Malatesha', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}]","Dyslexia (Chichester, England)",['10.1002/dys.1634']
1787,31872894,Does adoption of an evidence-based practice lead to job turnover? Results from a randomized trial.,"It is important to understand the impact of implementation of evidence-based practices (EBPs) on the workforce. EBP implementation can increase job demands, stress, and burnout, and may thereby exacerbate turnover. This study examined the effects of implementation of an EBP on turnover among staff at nine child welfare agencies. A total of 102 providers were randomized to either adopt an EBP, SafeCare ©  , or continue providing services as usual. Participants completed a baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover was recorded for up to 18 months following implementation. The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]). Variables associated with turnover included age (OR = 0.92), years since degree completion (OR = 0.94), prior exposure to EBP (OR = 3.91), believing that adopting an EBP was burdensome (OR = 0.52), and motivation for change (OR = 0.89). EBP assignment moderated two aspects of negative attitudes toward EBP (divergence and monitoring) to predict turnover; those attitudes were only positively related to turnover for individuals assigned to the EBP (OR = 1.46, 1.16). Implications of the findings for implementation are discussed.",2020,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).",['A total of 102 providers'],"['EBP implementation', 'EBP, SafeCare ©  , or continue providing services as usual', 'EBP']","['overall turnover rate', 'baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0301051,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Zahidi', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}]",Journal of community psychology,['10.1002/jcop.22305']
1788,32428840,Acute effects of time-restricted feeding in low-income women with obesity placed on hypoenergetic diets: Randomized trial.,"OBJECTIVE


The aim of this study was to evaluate the acute effects of time-restricted feeding in obese women living in social vulnerability who were placed on diets with the same energy deficit.
METHODS


Fifty-eight obese women (19-44 y of age) were randomized to a group with a hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet for 21 d, with body weight and waist circumference monitoring up to 81 d of intervention. The determination of the individual's energy content of the diets was based on their resting metabolic rate (by indirect calorimetry) and physical activity level (by triaxial accelerometers). Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin were measured before and after 21 d of intervention. A mixed analysis of variance test was performed.
RESULTS


The women had a mean age of 31 y and mean body mass index of 33 kg/m². Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group. Also, there was a significant decrease in waist circumference in the time-restricted feeding group after 81 d. There were no differences in hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty.
CONCLUSION


Time-restricted feeding may be considered an alternative strategy for treating obesity in socially vulnerable women.",2020,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","['obese women living in social vulnerability who were placed on diets with the same energy deficit', 'low-income women with obesity placed on hypoenergetic diets', 'women had a mean age of 31 y and mean body mass index of 33 kg/m²', 'socially vulnerable women', 'Fifty-eight obese women (19-44 y of age']","['time-restricted feeding', 'hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet']","['resting metabolic rate (by indirect calorimetry) and physical activity level', 'Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin', 'waist circumference', 'axillary temperature', 'hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty', 'body fat']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",58.0,0.0653357,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","[{'ForeName': 'Isabele R O M', 'Initials': 'IROM', 'LastName': 'Pureza', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: isabelemaranhaonut@hotmail.com.'}, {'ForeName': 'Ingrid S V', 'Initials': 'ISV', 'LastName': 'Melo', 'Affiliation': 'Instituto Federal de Alagoas, Alagoas, Brazil. Electronic address: ingrid.melo@ifal.edu.br.'}, {'ForeName': 'Mateus L', 'Initials': 'ML', 'LastName': 'Macena', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: m.l.macena@hotmail.com.'}, {'ForeName': 'Dafiny R S', 'Initials': 'DRS', 'LastName': 'Praxedes', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: dafiny_rodrigues96@hotmail.com.'}, {'ForeName': 'Laís G L', 'Initials': 'LGL', 'LastName': 'Vasconcelos', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: laisglv@gmail.com.'}, {'ForeName': 'André E', 'Initials': 'AE', 'LastName': 'Silva-Júnior', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: andreeduardojr@hotmail.com.'}, {'ForeName': 'Telma M M T', 'Initials': 'TMMT', 'LastName': 'Florêncio', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: telmatf_al@hotmail.com.'}, {'ForeName': 'Nassib B', 'Initials': 'NB', 'LastName': 'Bueno', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: nassib.bueno@fanut.ufal.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110796']
1789,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND


Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS.
METHODS


The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period.
RESULTS


The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2  = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
CONCLUSIONS


Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106']
1790,32063029,Adding new experimental arms to randomised clinical trials: Impact on error rates.,"BACKGROUND


Experimental treatments pass through various stages of development. If a treatment passes through early-phase experiments, the investigators may want to assess it in a late-phase randomised controlled trial. An efficient way to do this is adding it as a new research arm to an ongoing trial while the existing research arms continue, a so-called multi-arm platform trial. The familywise type I error rate is often a key quantity of interest in any multi-arm platform trial. We set out to clarify how it should be calculated when new arms are added to a trial some time after it has started.
METHODS


We show how the familywise type I error rate, any-pair and all-pairs powers can be calculated when a new arm is added to a platform trial. We extend the Dunnett probability and derive analytical formulae for the correlation between the test statistics of the existing pairwise comparison and that of the newly added arm. We also verify our analytical derivation via simulations.
RESULTS


Our results indicate that the familywise type I error rate depends on the shared control arm information (i.e. individuals in continuous and binary outcomes and primary outcome events in time-to-event outcomes) from the common control arm patients and the allocation ratio. The familywise type I error rate is driven more by the number of pairwise comparisons and the corresponding (pairwise) type I error rates than by the timing of the addition of the new arms. The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
CONCLUSIONS


The findings we present in this article can be used to design trials with pre-planned deferred arms or to add new pairwise comparisons within an ongoing platform trial where control of the pairwise error rate or familywise type I error rate (for a subset of pairwise comparisons) is required.",2020,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
",[],[],[],[],[],[],,0.202982,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Choodari-Oskooei', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Meade', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh Kb', 'Initials': 'MK', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520904346']
1791,32428636,Non-Pharmacological interventions for the anxiety in patients with dementia. A cross-over randomised controlled trial.,"BACKGROUND


Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to be a crucial and big problem in dementia. Anxiety several times remains under-diagnosed because it is often considered to be a psychological response to cognitive decline. As only the 10 % of patients were correctly treated, the pharmacological treatment should be well- considered. The aim of this study was to evaluate three non-pharmacological interventions for the treatment of anxiety in dementia.
METHODS


A cross-over randomised controlled trial with 60 participants (different types and stages of dementia) conducted in Greece. The sample was randomly assigned to 6 different groups of 10 participants each. The non-pharmacological interventions that have been evaluated are: a) Music Therapy b) Exercise and c) Aromatherapy & Massage. The measurements that were used are: MMSE, ACE-R, GDS, FRSSD and NPI questionnaire. The interventions lasted 5 days and there was two days off as a wash-out period. There was no drop-out rate.
RESULTS


The study showed that the most effective intervention is Music therapy. The second most effective intervention is Exercise and the third one is Aromatherapy and Massage. In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results. (p = <0.05, p = 0.55, accordingly). Caregivers' burden also reduced with MT. In the parenthesis p results indicate Music Therapy's p is less than 0.05 in comparison with the two other interventions and therefore the sequence of the interventions does not interfere with the results, as well (p = <0.05, p = 0.19).
CONCLUSIONS


Our results are in accordance with the current literature. Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD. Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD, such as lack of sleep, lack of personal time, unhealthy lifestyle, lack of solutions on what to do with their patients etc. The type of music, the duration of the intervention and the long-term benefits remain unclear. There is a big need of further research with stronger possible evaluation methods.",2020,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"['60 participants (different types and stages of dementia) conducted in Greece', 'dementia (BPSD', 'patients with dementia', 'anxiety in dementia']","['Music Therapy', 'Music Therapy b) Exercise and c) Aromatherapy & Massage']","['MMSE, ACE-R, GDS, FRSSD and NPI questionnaire']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0553418,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"[{'ForeName': 'Tatiana-Danai', 'Initials': 'TD', 'LastName': 'Dimitriou', 'Affiliation': 'Aristotle University of Thessaloniki, 44 Salaminos Street, Halandri, 15232, Athens, Greece. Electronic address: tt.kirxof@gmail.com.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Verykouki', 'Affiliation': 'Department of Hygiene, Social Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, 54124, Thessaloniki, Makedonia, Greece. Electronic address: e.verykouki@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Papatriantafyllou', 'Affiliation': ""3rd Age Center IASIS, 2nd Neurology Dpt., University of Athens, 'Attikon' Hospital, 73 Krimeas Str., Glyfada, Athens, Greece. Electronic address: jpapatriantafyllou@gmail.com.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Konsta', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, Greece. Electronic address: konstaa@auth.gr.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazis', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloníki, Greece. Electronic address: dimitrios.kazis@gmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '1st Department of Neurology, Aristotle University of Thessaloniki, Makedonia, 3 Despere Street, Thessaloniki, Greece. Electronic address: tsolakim1@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112617']
1792,32434498,"Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol.","BACKGROUND


Knee osteoarthritis (OA) is a common, chronic, progressive and degenerative disease which affects patients' quality of life and may cause disability and social isolation. OA is a huge economic burden for the patient and a large strain for the whole healthcare system. Articular cartilage has a small potential to repair, with progressively more clinicians emphasizing cellular therapy. Subcutaneous fat tissue in human body is a large reservoir of mesenchymal stem cells (MSCs) and is been harvested in minimally invasive, simple procedure. Up to date there is no prospective randomized controlled studies demonstrating effectiveness and role of adipose tissue injections in OA treatment. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or platelet rich plasma (PRP) and to compare efficacy of both therapeutic methods.
METHODS


This is a prospective, randomized, controlled study. Patients who meet inclusion criteria will be allocated to Fat Tissue group or PRP group randomly. Subjects will receive an intra articular injection with autologous adipose tissue and PRP respectively. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The assessment consists of patient reported outcome measures (The Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ- 5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
DISCUSSION


This study protocol has several strengths and weaknesses. One of strongest point of this study is the wide, multidimensional functional assessment which will give a large amount of objective data. On the other hand, lack of blinding has to be considered as a risk of both subject and investigator bias.
TRIAL REGISTRATION


name of registry: ClinicalTrials.gov, trial registration number: NCT04321629, retrospectively registered on date of registration.",2020,"5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
","['knee osteoarthritis', 'patients with symptomatic knee OA treated with']","['Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection', 'intra-articular injections of autologous adipose tissue or platelet rich plasma (PRP', 'Fat Tissue group or PRP', 'OA']","['Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0666242,"5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
","[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bąkowski', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland. pawel.bakowski@rehasport.pl.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kaszyński', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wałecka', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Ciemniewska-Gorzela', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Bąkowska-Żywicka', 'Affiliation': 'Institute of Bioorganic Chemistry Polish Academy of Sciences, Poznan, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03345-8']
1793,31916578,Unpacking the 'black box' of lay health worker processes in a US-based intervention.,"Prior studies have supported the effectiveness of the use of Lay Health Workers (LHWs) as an intervention model for managing chronic health conditions, yet few have documented the mechanisms that underlie the effectiveness of the interventions. This study provides a first look into how LHWs delivered a family-based intervention and the challenges encountered. We utilize observation data from LHW-led educational sessions delivered as part of a randomized controlled trial (RCT) designed to test a LHW outreach family-based intervention to promote smoking cessation among Vietnamese American smokers. The RCT included experimental (smoking cessation) and control (healthy living) arms. Vietnamese LHWs were trained to provide health information in Vietnamese to groups of family dyads (smoker and family member). Bilingual, bicultural research team members conducted unobtrusive observations in a subset of LHW educational sessions and described the setting, process and activities in structured fieldnotes. Two team members coded each fieldnote following a grounded theory approach. We utilized Atlas.ti qualitative software to organize coding and facilitate combined analysis. Findings offer a detailed look at the 'black box' of how LHWs work with their participants to deliver health messages. LHWs utilized multiple relational strategies, including preparing an environment that enables relationship building, using recognized teaching methods to engage learners and co-learners as well as using humor and employing culturally specific strategies such as hierarchical forms of address to create trust. Future research will assess the effectiveness of LHW techniques, thus enhancing the potential of LHW interventions to promote health among underserved populations.",2020,"Prior studies have supported the effectiveness of the use of Lay Health Workers (LHWs) as an intervention model for managing chronic health conditions, yet few have documented the mechanisms that underlie the effectiveness of the interventions.",['Vietnamese American smokers'],"['LHW-led educational sessions', 'LHW outreach family-based intervention']",[],"[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0185794,"Prior studies have supported the effectiveness of the use of Lay Health Workers (LHWs) as an intervention model for managing chronic health conditions, yet few have documented the mechanisms that underlie the effectiveness of the interventions.","[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Burke', 'Affiliation': 'Public Health, University of California, Merced, 5200 N Lake Rd., Merced, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Phung', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Filmer', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Khanh', 'Initials': 'K', 'LastName': 'Le', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Nguyen', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Guan', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Tung T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Tsoh', 'Affiliation': 'Asian American Research Center on Health, University of California, 3333 California, San Francisco, CA, USA.'}]",Health promotion international,['10.1093/heapro/day094']
1794,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
1795,32012062,"Correction: Comparison of YouthCHAT, an Electronic Composite Psychosocial Screener, With a Clinician Interview Assessment for Young People: Randomized Trial.",[This corrects the article DOI: 10.2196/13911.].,2020,[This corrects the article DOI: 10.2196/13911.].,['Young People'],['YouthCHAT'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]",[],[],,0.0227854,[This corrects the article DOI: 10.2196/13911.].,"[{'ForeName': 'Hiran', 'Initials': 'H', 'LastName': 'Thabrew', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': ""D'Silva"", 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Darragh', 'Affiliation': 'Department of General Practice, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Goldfinch', 'Affiliation': 'Tamaki College, Auckland, New Zealand.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Meads', 'Affiliation': 'School of Health Science, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Goodyear-Smith', 'Affiliation': 'Department of General Practice, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/17339']
1796,31521029,Effectiveness of an indigenous parent training program on change in parenting styles and delinquent tendencies (challenging behaviors) in Pakistan: A randomized controlled trial.,"The effectiveness of an indigenous parent training program was examined within selected Pakistani families. For this purpose, 110 parents of adolescents with above-average levels of delinquent tendencies (challenging behaviors), who were screened and chosen from five randomly selected schools in Lahore, Punjab, Pakistan, participated in the study. The adolescents' parents were randomly placed into either an intervention group or a control group. Members of the intervention group participated in seven sessions of parent training, which aimed to increase behaviors associated with an authoritative parenting style. Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up. In addition, their children showed reductions in parent-reported challenging behaviors. Declines in challenging behaviors were explained by increases in authoritative parenting behaviors, although not all intervention effects could be explained by such increases. We conclude that, similar to Western countries, the authoritative parenting style is the most effective parenting style for managing adolescents' challenging behaviors in Pakistan.",2019,Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up.,"[""adolescents' parents"", '110 parents of adolescents with above-average levels of delinquent tendencies (challenging behaviors), who were screened and chosen from five randomly selected schools in Lahore, Punjab, Pakistan, participated in the study', 'parenting styles and delinquent tendencies (challenging behaviors) in Pakistan']",['indigenous parent training program'],"['authoritative parenting behaviors', 'authoritarian and neglectful parenting behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0522175', 'cui_str': 'Delinquent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1828250', 'cui_str': 'Neglectful parenting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",110.0,0.0395175,Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up.,"[{'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Kauser', 'Affiliation': 'Faculty of Psychology, Philipps University Marburg, 35032 Marburg, Germany. Electronic address: rubina.kauser@staff.uni-marburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pinquart', 'Affiliation': 'Faculty of Psychology, Philipps University Marburg, 35032 Marburg, Germany.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104677']
1797,32429848,A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.,"BACKGROUND


Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual.
METHODS


We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later.
RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists.
CONCLUSIONS


Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.",2020,"RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","['A higher proportion of responders vs. non-responders were young (ages 25-44\u2009years), men, and radiation or surgical (vs. medical) oncologists']","['Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online', 'mail and email recruitment strategies', 'American Medical Association MasterFile (n\u2009=\u200913,251) to mail- or email-based recruitment strategies']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002461', 'cui_str': 'AMA - American Medical Association'}]",[],,0.0660322,"RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA. caitlin.murphy@utsouthwestern.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Craddock Lee', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Geiger', 'Affiliation': 'Healthcare Delivery Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Cox', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}]",BMC medical research methodology,['10.1186/s12874-020-01014-x']
1798,32434504,Implementation of an interactive organ donation education program for Dutch lower-educated students: a process evaluation.,"BACKGROUND


As organ donation registration rates remain low, especially among lower-educated people, it is important to support this group in making their registration decision. To prepare lower-educated students in the Netherlands for making a well-informed decision, an interactive educational program was developed. We aim to understand both the (quality of) implementation as well as to contextualize the effects of this program in a lower-educated school setting.
METHODS


The process evaluation was part of a Cluster Randomized Controlled Trial, in which 11 schools for Intermediate Vocational Education throughout the Netherlands participated. Teachers who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and an exercise filling out a registration form) to their students. Implementation was assessed by interviews with teachers, questionnaires from students, logbooks from teachers and user data from Google Analytics.
RESULTS


The program was well received and implemented, but on-the-spot adaptations were made by teachers to fit their students better. Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span. The program fit well within their regular teaching activities, but the topic of organ donation is not always prioritized by teachers.
CONCLUSIONS


We see opportunities to disseminate the program on a larger scale and reach a group that has been neglected in organ donation education before. Within the program, there are possibilities to increase the effectiveness of the program, such as alternative delivery methods for the elements with a lot of text, the addition of booster sessions and guidelines for teachers to adapt the program to students of different levels within Intermediate Vocational Education. Moreover, in order to have an impact on a national level, strategies need to be employed to reach high numbers of students and, therefore, support on a higher level is needed (both within schools and at policy level).
TRIAL REGISTRATION


Dutch Trial Register, NTR6771. Prospectively registered on 24 October 2017.",2020,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","['11 schools for Intermediate Vocational Education throughout the Netherlands participated', 'Dutch lower-educated students', 'Prospectively registered on 24 October 2017']",['interactive organ donation education program'],"['active participation, reading abilities, knowledge and attention span']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0042933', 'cui_str': 'Vocational schooling'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0367916,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Steenaart', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. e.steenaart@maastrichtuniversity.nl.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Nanne K', 'Initials': 'NK', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}]",BMC public health,['10.1186/s12889-020-08900-5']
1799,31419483,Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial.,"OBJECTIVES


The aim was to evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 g, the recommended European first-line gonorrhoea treatment.
METHODS


A non-inferiority, open-label, single-centre randomized controlled trial was conducted in Prague, Czech Republic. Patients, 18-75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomized to treatment with gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin 2 g orally. The primary outcome was negative culture and negative NAAT, i.e. 1 week and 3 weeks, respectively, after treatment.
RESULTS


Both clinical cure and microbiological clearance was achieved by 100% (95% CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n = 72; 40 rectal, 17 pharyngeal and 15 rectal+pharyngeal infections both localizations) and 100% (95% CI 0.95-1.00) in ceftriaxone/azithromycin arm (n = 71; 38 rectal, 14 pharyngeal and 19 rectal+pharyngeal infections). The absolute difference between the two arms was 0.0% (CI95% -5.1 to 5.1), thus less than the pre-specified margin of 7%. Administration of gentamicin was not more painful than ceftriaxone according to the visual analogue scale (1.8 vs. 3.4; p <0.001). Gastrointestinal adverse events were similar in the ceftriaxone arm (33/71, 46.5%) and the gentamicin arm (29/72, 40.3%), and overall in most (52/62, 83.9%) cases they were mild.
CONCLUSIONS


Gentamicin 240 mg plus azithromycin 2 g is an effective alternative for treatment of extragenital gonorrhoea.",2020,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","['rectal and pharyngeal gonorrhoea', 'A non-inferiority, open-label, single centre randomized controlled trial was conducted in Prague, Czech Republic', 'Patients, 18-75\xa0years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT']","['ceftriaxone/azithromycin', 'gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin', 'ceftriaxone 500 mg plus azithromycin', 'Gentamicin 240 mg plus azithromycin', 'gentamicin 240 mg plus azithromycin', 'gentamicin', 'gentamicin/azithromycin', 'ceftriaxone']","['negative culture and negative NAAT', 'clinical cure and microbiological clearance', 'visual analog scale', 'efficacy and tolerability', 'Gastrointestinal adverse events']","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.117736,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rob', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. Electronic address: filip.rob@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klubalová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nyčová', 'Affiliation': 'Department of Microbiology, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hercogová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.08.004']
1800,31244398,The Effects of News Coverage of Epidemics on Public Support for and Compliance with the CDC- An Experimental Study.,"Content analysis identified three dominant themes used by the news media to cover epidemics: the scientific, the pandemic, and the social. This study uses a randomized experimental design to test the effects of common news coverage patterns of epidemics on perceptions of efficacy, certainty, and trust in the CDC, and subsequently on intentions to comply with and support for the CDC during public health crises. The experiment also compares the effects of real-world coverage to that of hypothetical coverage that more closely follows the CDC's recommendations for crisis communication. The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC. Although organizational-efficacy and trust in the CDC are both correlated with intentions to support, and trust is also correlated with intentions to comply, exposure to different conditions did not affect these perceptions and there was no indirect effect from exposure to intentions. The results reveal the potential effects of real-world coverage on perceptions and intentions, and demonstrate the advantage of the hypothetical coverage that follows the CDC's crisis communication guidelines. Implications for public health organizations and communicators are discussed.",2019,"The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC.",[],[],[],[],[],[],321.0,0.012992,"The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC.","[{'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Ophir', 'Affiliation': 'a The Department of Communication, University at Buffalo, State University of New York , Buffalo , NY , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1632990']
1801,31201218,"A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia.","BACKGROUND


Patients with ESRD have minimal renal potassium excretion and, despite hemodialysis, often have persistent predialysis hyperkalemia. The DIALIZE study (NCT03303521) evaluated sodium zirconium cyclosilicate (SZC) in the management of hyperkalemia in hemodialysis patients.
METHODS


In the DIALIZE study, a double-blind, placebo-controlled, phase 3b multicenter study, we randomized adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive placebo or SZC 5 g once daily on non-dialysis days, and titrated towards maintaining normokalemia over 4 weeks, in 5 g increments to a maximum of 15 g. The primary efficacy outcome was proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium of 4.0-5.0 mmol/L during at least three of four hemodialysis treatments after the long interdialytic interval and did not require urgent rescue therapy to reduce serum potassium.
RESULTS


In total, 196 patients (mean [standard deviation (SD)] age =58.1 [13.7] years old) were randomized to sodium zirconium cyclosilicate or placebo. Of 97 patients receiving sodium zirconium cyclosilicate, 41.2% met the primary end point and were deemed treatment responders compared with 1.0% of 99 patients receiving placebo ( P <0.001). Rescue therapy to reduce serum potassium during the treatment period was required by 2.1% of patients taking sodium zirconium cyclosilicate versus 5.1% taking placebo. Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively. The two groups displayed comparable interdialytic weight gain. There were few episodes of hypokalemia.
CONCLUSIONS


Sodium zirconium cyclosilicate is an effective and well-tolerated treatment for predialysis hyperkalemia in patients with ESRD undergoing adequate hemodialysis.",2019,"Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively.","['adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive', 'patients with ESRD undergoing adequate hemodialysis', '196 patients (mean [standard deviation (SD', '97 patients receiving', 'hemodialysis patients', 'Patients with ESRD', 'age =58.1 [13.7] years old']","['sodium zirconium cyclosilicate (SZC', 'placebo', 'placebo or SZC 5', 'Placebo', 'sodium zirconium cyclosilicate', 'Sodium zirconium cyclosilicate', 'sodium zirconium cyclosilicate or placebo', 'Sodium Zirconium Cyclosilicate']","['interdialytic weight gain', 'proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium', 'hypokalemia', 'Serious adverse events', 'Incidence of Predialysis Hyperkalemia', 'serum potassium']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}]",196.0,0.250443,"Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York; Sfishbane@northwell.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ford', 'Affiliation': ""Department of Renal Medicine, King's College Hospital NHS Trust, London, United Kingdom.""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McCafferty', 'Affiliation': 'Department of Nephrology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Spinowitz', 'Affiliation': 'Department of Medicine, New York-Presbyterian Queens, Queens, New York.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Staroselskiy', 'Affiliation': 'Department #2, B. Braun Avitum Russland Clinics, St. Petersburg, Russia.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'Propedeutics of Internal Diseases Chair, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Lisovskaja', 'Affiliation': 'Biometrics and Information and.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Shurbaji', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Guzman', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland; and.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Department of Renal and Transplant Medicine, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019050450']
1802,31240605,"""Get Ready and Empowered About Treatment"" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.","BACKGROUND


Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH).
OBJECTIVE


To assess the impact of a group intervention and individual coaching on patient activation for PLWH.
DESIGN


Pragmatic randomized controlled trial.
SITES


Eight practices in New York and two in New Jersey serving PLWH.
PARTICIPANTS


Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy.
INTERVENTION


Six 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20-30 min individual pre-visit coaching session.
MAIN MEASURES


The primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL).
KEY RESULTS


The intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32-5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16-3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38-3.9) and PICS (1.27: 95% CI 0.41-2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load.
CONCLUSIONS


The patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation.
TRIAL REGISTRATION


This study is registered at Clinical Trials.Gov (NCT02165735).",2019,"No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load.
","['Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy', 'persons living with HIV (PLWH', 'Persons Living with HIV']","['group intervention and individual coaching', 'ePersonal Health Record loaded onto a handheld mobile device and a single 20-30\xa0min individual pre-visit coaching session']","['changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL', 'PAM', 'decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load', 'improvement in eHEALS', 'change in Patient Activation Measure (PAM']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C4075707', 'cui_str': 'PAM - Patient Activation Measure'}]",360.0,0.204054,"No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load.
","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY, USA.'}, {'ForeName': 'Amneris', 'Initials': 'A', 'LastName': 'Luque', 'Affiliation': 'Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Subrina', 'Initials': 'S', 'LastName': 'Farah', 'Affiliation': 'Department of Family Medicine, Family Medicine Research Programs, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Mechelle', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Department of Family Medicine, Family Medicine Research Programs, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cassells', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Fine', 'Affiliation': 'Department of Family Medicine, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': 'Department of Psychiatry, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Department of Family Medicine, Family Medicine Research Programs, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Tameir', 'Initials': 'T', 'LastName': 'Holder', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Family Medicine, Family Medicine Research Programs, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Cleo Clarize', 'Initials': 'CC', 'LastName': 'Overa', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Department of Family Medicine, Family Medicine Research Programs, University of Rochester, Rochester, NY, USA. Kevin_fiscella@urmc.rochester.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05102-7']
1803,29485340,Incentive spirometry and positive expiratory pressure improve ventilation and recruitment in postoperative recovery: A randomized crossover study.,"Introduction : Impairment of global and regional pulmonary ventilations is a well-known consequence of general anesthesia. Positive expiratory pressure (PEP) or incentive spirometry (IS) is commonly prescribed, albeit their efficacy is poorly demonstrated. The aim of this study was to assess the effects of PEP and IS on lung ventilation and recruitment in patients after surgery involving anesthesia using electrical impedance tomography (EIT).  Method : Ten male subjects (age = 61.2 ± 16.3 years; BMI = 25.3 ± 3.8 kg/m 2 ), free of pulmonary disease before being anesthetized, were recruited. Two series of manoeuvers (PEP and volume-oriented IS) were randomly performed with quiet breathing interposed between these phases. Pulmonary ventilation (ΔEELVVT ( i  -  e )) and recruitment (ΔEELI) were evaluated continuously in a semi-seated position during all phases by EIT. Comparisons between rest and treatment were performed by Wilcoxon signed rank test. Rest phases were compared by a mixed ANOVA. Bonferroni method was used for  post-hoc  comparisons.  Results : ΔEELVVT ( i  -  e ) and ΔEELI were significantly increased by both techniques (+422% [ p  < 0.001]; +138% [ p  = 0.040] and +296% [ p  < 0.001]; +638% [ p  < 0.001] for PEP and IS, respectively). No difference was observed between both manoeuvers neither on ventilation nor on recruitment. This positive effect disappeared during the quiet breathing phases.  Conclusion : IS and PEP improved ventilation and recruitment instantaneously without remnant effect after stopping the exercise.",2019,No difference was observed between both manoeuvers neither on ventilation nor on recruitment.,"['patients after surgery involving anesthesia using electrical impedance tomography (EIT', 'Ten male subjects (age\xa0=\xa061.2\xa0±\xa016.3\xa0years; BMI\xa0=\xa025.3\xa0±\xa03.8\xa0kg/m 2 ), free of pulmonary disease before being anesthetized, were recruited', 'postoperative recovery']","['PEP', 'Incentive spirometry and positive expiratory pressure improve ventilation']","['ΔEELI', 'Positive expiratory pressure (PEP) or incentive spirometry (IS', 'Pulmonary ventilation (ΔEELVVT (i\xa0-\xa0e)) and recruitment (ΔEELI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C0035213', 'cui_str': 'Respiratory Airflow'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",10.0,0.0460672,No difference was observed between both manoeuvers neither on ventilation nor on recruitment.,"[{'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Valeska', 'Initials': 'V', 'LastName': 'Uribe Rodriguez', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Cheryl Elizabeth', 'Initials': 'CE', 'LastName': 'Hickmann', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""Service d'Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium.""}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Feyaerts', 'Affiliation': ""Service d'Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Roeseler', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1443185']
1804,32434492,Loneliness as a predictor of outcomes in mental disorders among people who have experienced a mental health crisis: a 4-month prospective study.,"BACKGROUND


Loneliness has not until recently been a prominent focus in research on outcomes of mental illness. The aim of this study was to determine whether loneliness at baseline predicts poor outcomes at 4-month follow-up for individuals who have experienced mental health crises. The outcomes in this study included overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life.
METHODS


Our study reports a secondary analysis of data from a randomised controlled trial. The sample (n = 399) was taken from patients who received treatment from community crisis services. Respondents (n = 310) completed the follow-up measurement 4 months after baseline. Loneliness at baseline was assessed using an eight-item UCLA Loneliness Scale. The four mental health outcomes were measured at both baseline and follow-up. Two scales (or part thereof) assessed objective social isolation and neighbourhood social capital at baseline. Regression analyses were conducted to investigate longitudinal associations between loneliness at baseline and mental health outcomes at follow-up.
RESULTS


Loneliness at baseline was associated with all four mental health outcomes at 4-month follow-up, adjusting for psychosocial, socio-demographic and clinical characteristics. A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively. Loneliness was a better predictor of clinical outcomes than objective social isolation and social capital, even though the associations with clinical outcomes were reduced and no longer statistically significant following adjustment for their baseline values. A significant association with quality of life persisted after adjustment for its baseline score.
CONCLUSIONS


Greater loneliness at baseline predicted poorer health-related quality of life at follow-up. There were cross-sectional associations between loneliness and clinical outcomes, but their longitudinal relationship cannot be confirmed. Further research is needed to clearly establish their underpinning pathways. Reducing loneliness may be a promising target to improve recovery for mental health community crisis service users.",2020,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","['people who have experienced a mental health crisis', 'individuals who have experienced mental health crises', 'mental health community crisis service users']",[],"['quality of life', 'self-rated recovery score and health-related quality of life score', 'overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life', 'health-related quality of life', 'overall symptom severity score and affective symptoms score', 'loneliness score', 'objective social isolation and neighbourhood social capital']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",,0.216986,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. jingyi.wang.13@ucl.ac.uk.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, UCL Medical School, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Mann', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.johnson@ucl.ac.uk.'}]",BMC psychiatry,['10.1186/s12888-020-02665-2']
1805,32434574,Mismatch between self-perceived and calculated cardiometabolic disease risk among participants in a prevention program for cardiometabolic disease: a cross-sectional study.,"BACKGROUND


The rising prevalence of cardiometabolic diseases (CMD) calls for effective prevention programs. Self-assessment of CMD risk, for example through an online risk score (ORS), might induce risk reducing behavior. However, the concept of disease risk is often difficult for people to understand. Therefore, the study objective was to assess the impact of communicating an individualized CMD risk score through an ORS on perceived risk and to identify risk factors and demographic characteristics associated with risk perception among high-risk participants of a prevention program for CMD.
METHODS


A cross-sectional analysis of baseline data from a randomized controlled trial conducted in a primary care setting. Seven thousand five hundred forty-seven individuals aged 45-70 years without recorded CMD, hypertension or hypercholesterolemia participated. The main outcome measures were: 1) differences in cognitive and affective risk perception between the intervention group - who used an ORS and received an individualized CMD risk score- and the control group who answered questions about CMD risk, but did not receive an individualized CMD risk score; 2) risk factors and demographic characteristics associated with risk perception.
RESULTS


No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants. A positive family history for diabetes type 2 (β0.56, CI95% 0.39-0.73) and cardiovascular disease (β0.28, CI95% 0.13-0.43), BMI ≥25 (β0.27, CI95% 0.12-0.43), high waist circumference (β0.25, CI95% 0.02-0.48) and physical inactivity (β0.30, CI95% 0.16-0.45) were positively associated with cognitive CMD risk perception in high-risk participants. No other risk factors or demographic characteristics were associated with risk perception.
CONCLUSIONS


Communicating an individualized CMD risk score did not affect risk perception. A mismatch was found between calculated risk and self-perceived risk in high-risk participants. Family history and BMI seem to affect the level of CMD risk perception more than risk factors such as sex, age and smoking. A dialogue about personal CMD risk between patients and health care professionals might optimize the effect of the provided risk information.
TRIAL REGISTRATION


Dutch trial Register number NTR4277, registered 26th Nov 2013.",2020,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","['Seven thousand five hundred forty-seven individuals aged 45-70\u2009years without recorded CMD, hypertension or hypercholesterolemia participated', 'participants in a prevention program for cardiometabolic disease', 'high-risk participants of a prevention program for CMD']",[],"['high waist circumference', 'risk perception', 'cardiovascular disease', 'level of CMD risk perception', 'cognitive CMD risk perception', 'physical inactivity', 'cognitive and affective risk perception']","[{'cui': 'C4517869', 'cui_str': '7500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",7547.0,0.0357281,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands. d.m.stol@umcutrecht.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Damman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",BMC public health,['10.1186/s12889-020-08906-z']
1806,32432550,A Brief Music App to Address Pain in the Emergency Department: Prospective Study.,"BACKGROUND


Emergency physicians face the challenge of relieving acute pain daily. While opioids are a potent treatment for pain, the opioid epidemic has ignited a search for nonopioid analgesic alternatives that may decrease the dose or duration of opioid exposure. While behavioral therapies and complementary medicine are effective, they are difficult to deploy in the emergency department. Music is a potential adjunctive therapy that has demonstrated effectiveness in managing pain.
OBJECTIVE


Our objective was to understand the feasibility and potential for an effect of a novel music app to address acute pain and anxiety in patients admitted to an emergency department observation unit.
METHODS


This prospective cohort study enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids. We gathered baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing using validated questionnaires. Participants received a smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant). The app collected premusic and postmusic pain and anxiety scores, and participants provided qualitative feedback regarding acceptability of operating the music intervention.
RESULTS


We enrolled 81 participants and randomly assigned 38 to an unsupervised and 43 to a supervised group. Mean pain in both groups was 6.1 (1.8) out of a possible score of 10. A total of 43 (53%) reported previous use of music apps at home. We observed an overall modest but significant decrease in pain (mean difference -0.81, 95% CI -0.45 to -1.16) and anxiety (mean difference -0.72, 95% CI -0.33 to -1.12) after music sessions. Reduction of pain and anxiety varied substantially among participants. Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief. Changes in pain were correlated to changes in anxiety (Pearson ρ=0.3, P=.02) but did not vary between supervised and unsupervised groups. Upon conclusion of the study, 46/62 (74%) reported they liked the music intervention, 57/62 (92%) reported the app was easy to use, and 49/62 (79%) reported they would be willing to use the music intervention at home.
CONCLUSIONS


A smartphone-based music intervention decreased pain and anxiety among patients in an emergency department observation unit, with no difference between supervised and unsupervised use. Individuals reporting the greatest reduction in pain after music sessions included those scoring highest on baseline assessment of catastrophic thinking, suggesting there may be specific patient populations that may benefit more from using music as an analgesic adjunct in the emergency department. Qualitative feedback suggested that this intervention was feasible and acceptable by emergency department patients.",2020,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","['Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief', 'enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids', 'patients admitted to an emergency department observation unit']","['smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant', 'smartphone-based music intervention', 'Music App', 'novel music app']","['Changes in pain', 'pain and anxiety', 'anxiety', 'Mean pain', 'pain', 'baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing', 'acute pain and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4284828', 'cui_str': 'Observation Units'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",81.0,0.0985102,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Chai', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schwartz', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Mohammad Adrian', 'Initials': 'MA', 'LastName': 'Hasdianda', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Desiree R', 'Initials': 'DR', 'LastName': 'Azizoddin', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kikut', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Guruprasad D', 'Initials': 'GD', 'LastName': 'Jambaulikar', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Boyer', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}]",Journal of medical Internet research,['10.2196/18537']
1807,32428747,A synergistic effect between family intervention and rTMS improves cognitive and negative symptoms in schizophrenia: A randomized controlled trial.,"OBJECTIVE


The present study explored an efficient new therapy that combined repetitive transcranial magnetic stimulation (rTMS) and family intervention in addition to risperidone to improve schizophrenia.
METHODS


A randomized controlled trial (January 2016-September 2017) involving 200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research. The patients were randomly assigned to 12 weeks of treatment with risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group). MATRICS Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS) were used to evaluate treatment efficacy. Repeated measures analysis of variance (RMANOVA) were performed to evaluate different treatment efficacy between four groups after 12 weeks of treatment.
RESULTS


(1) There were no significant differences in sex, age, education, cognitive function, or PANSS scores between the four groups at baseline (p's > 0.05). (2) There was a significant decrease in the PANSS scores and an increase in the MCCB scores after 12 weeks of treatment in all groups (time effect p's < 0.001). (3) The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (p's < 0.05). (4) The combined group showed the superior effect in cognition function after 12 weeks. (5) And, interestingly, a remarkable synergistic effect between rTMS and family intervention therapy was observed.
CONCLUSION


There was a synergistic effect between rTMS and the family intervention as an effective combined therapy in improving schizophrenia. This study is registered with Chictr.org, number ChiCTR1900024422 (http://www.chictr.org.cn/edit.aspx?pid=34285&htm=4).",2020,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"['schizophrenia', '200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research']","['risperidone', 'combined repetitive transcranial magnetic stimulation (rTMS', 'risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group', 'rTMS']","['sex, age, education, cognitive function, or PANSS scores', 'MCCB scores', 'positive symptoms and negative symptoms', 'PANSS scores', 'Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS', 'cognitive and negative symptoms', 'cognition function']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",200.0,0.0287929,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiuxia', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, Peking University, Beijing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Supervision Bureau of the Health and Family Planning Commission, Wancheng District, Nanyang City, China.'}, {'ForeName': 'Qiyue', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Luxian', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Henan Province Mental Hospital, The Second Affiliated Hospital, Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xu-Feng', 'Initials': 'XF', 'LastName': 'Huang', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Medicine, University of Wollongong, NSW2522, Australia. Electronic address: xhuang@uow.edu.au.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China. Electronic address: fccsongxq@zzu.edu.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.009']
1808,32035231,Re: 'Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea' by Rob et al.,,2020,,[],['Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}]",[],,,,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Sfeir', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Clinical Microbiology Laboratories, University of Connecticut Health Center, Farmington, CT 06053, USA. Electronic address: sfeir@uchc.edu.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.01.035']
1809,32434495,Effect of sevoflurane and propofol on tourniquet-induced endothelial damage: a pilot randomized controlled trial for knee-ligament surgery.,"BACKGROUND


The glycocalyx layer is a key structure in the endothelium. Tourniquet-induced ischemic periods are used during orthopedic surgery, and the reactive oxygen species generated after ischemia-reperfusion may mediate the shedding of the glycocalyx. Here, we describe the effects of tourniquet-induced ischemia-reperfusion and compare the effects of sevoflurane and propofol on the release of endothelial biomarkers after ischemia-reperfusion in knee-ligament surgery.
METHODS


This pilot, single-center, blinded, randomized, controlled trial included 16 healthy patients. After spinal anesthesia, hypnosis was achieved with sevoflurane or propofol according to randomization. During the perioperative period, five venous blood samples were collected for quantification of syndecan-1, heparan sulfate, and thrombomodulin from blood serum by using ELISA assays kits. Sample size calculation was performed to detect a 25% change in the mean concentration of syndecan-1 with an alpha of 0.05 and power of 80%.
RESULTS


For our primary outcome, a two-way ANOVA with post-hoc Bonferroni correction analysis showed no differences in syndecan-1 concentrations between the sevoflurane and propofol groups at any time point. In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group. The two-way ANOVA showed no intergroup differences in heparan sulfate and thrombomodulin levels.
CONCLUSIONS


Superficial endothelial damage without alterations in the cell layer integrity was observed after tourniquet knee-ligament surgery. There was no elevation in serum endothelial biomarkers in the propofol group patients. Sevoflurane did not show the protective effect observed in in vitro and in vivo studies.
TRIAL REGISTRATION


The trial was registered in www.clinicaltrials.gov (ref: NCT03772054, Registered 11 December 2018).",2020,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","['16 healthy patients', 'knee-ligament surgery']","['sevoflurane and propofol', 'tourniquet-induced ischemia-reperfusion', 'sevoflurane', 'propofol', 'sevoflurane or propofol', 'Sevoflurane']","['syndecan-1 concentrations 90\u2009min after tourniquet release', 'endothelial biomarkers', 'cell layer integrity', 'syndecan-1 concentrations', 'serum endothelial biomarkers', 'heparan sulfate and thrombomodulin levels', 'tourniquet-induced endothelial damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0412803', 'cui_str': 'Tourniquet release'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",16.0,0.215818,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gutiérrez', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Barahona', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Cerda', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Cáceres', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile. monicacaceres@med.uchile.cl.'}]",BMC anesthesiology,['10.1186/s12871-020-01030-w']
1810,32432684,Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial.,"Importance


The 2018 American Heart Association/American College of Cardiology Multisociety Guideline on the Management of Blood Cholesterol identified patients with recent (past 12 months) myocardial infarction (MI) as very high risk, in whom a PCSK9 inhibitor is reasonable to add to maximally tolerated statin combined with ezetimibe if their low-density lipoprotein cholesterol level is 70 mg/dL or greater or non-high-density lipoprotein cholesterol level is 100 mg/dL or greater.
Objective


To examine the clinical efficacy of evolocumab in patients with recent MI.
Design, Setting, and Participants


This was a prespecified secondary analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, in which 27 564 patients with atherosclerotic cardiovascular disease treated with a statin were randomized to evolocumab vs placebo. Patients with prior MI with a known date (n = 22 320) were stratified as having a recent MI (within 12 months of randomization) or a remote MI (more than 12 months prior to randomization). Per protocol, patients with MI within 4 weeks prior to randomization were excluded from the FOURIER trial. Data were collected from February 2013 to November 2016, and data were analyzed from May 2019 to February 2020.
Main Outcomes and Measures


The primary composite end point was cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary composite end point was cardiovascular death, MI, or stroke.
Results


Of 22 320 included patients, 17 516 (78.5%) were male, and the mean (SD) age was 62.2 (9.0) years. Compared with 16 609 patients with a remote MI, 5711 patients with a recent MI were younger and more likely to be treated with high-intensity statin (77.3% [4415] vs 69.3% [11 506]). In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001). Similarly, the 3-year Kaplan-Meier rates for the key secondary end point was also higher in those with recent MI (10.9% vs 9.5%; adjusted HR, 1.45; 95% CI, 1.24-1.69; P < .001). In patients with a recent MI, evolocumab reduced the risk of the primary and key secondary end points by 19% (hazard ratio [HR], 0.81; 95% CI, 0.70-0.93) and 25% (HR, 0.75; 95% CI, 0.62-0.91), respectively. In patients with a remote MI, evolocumab reduced the risk of the primary and key secondary end points by 8% (HR, 0.92; 95% CI, 0.84-1.01; P for interaction = .13) and 15% (HR, 0.85; 95% CI, 0.76-0.96; P for interaction = .24), respectively. Given the higher event rates in patients with a recent MI, the absolute risk reductions over 3 years with evolocumab were 3.7% in those with recent MI vs 1.1% in those with remote MI for the primary end point and 3.2% vs 1.3%, respectively, for the key secondary end point.
Conclusions and Relevance


Patients with a recent MI were at higher risk of cardiovascular events and tended to experience greater absolute risk reductions with evolocumab than those with remote MIs. These findings support the concept in US and European guidelines to aggressively lower low-density lipoprotein cholesterol levels in very high-risk patients, such as those with a recent MI.
Trial Registration


ClinicalTrials.gov Identifier: NCT01764633.",2020,"In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001).","['Subjects With Elevated Risk (FOURIER) trial, in which 27 564 patients with atherosclerotic cardiovascular disease treated with a statin', 'Patients With Recent Myocardial Infarction', 'Patients with prior MI with a known date (n\u2009=\u200922\u202f320', 'Data were collected from February 2013 to November 2016, and data were analyzed from May 2019 to February 2020', '2018 American Heart Association/American College of Cardiology Multisociety Guideline on the Management of Blood Cholesterol identified patients with recent (past 12 months) myocardial infarction (MI', 'Results\n\n\nOf 22\u202f320 included patients, 17\u202f516 (78.5%) were male, and the mean (SD) age was 62.2 (9.0) years', 'patients with recent MI']","['placebo', 'Evolocumab', 'evolocumab', 'evolocumab vs placebo']","['low-density lipoprotein cholesterol levels', '3-year Kaplan-Meier rates', 'cardiovascular death, MI, or stroke', 'cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization', '3-year Kaplan-Meier rate', 'absolute risk reductions', 'Cardiovascular Outcomes', 'cardiovascular events']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",27564.0,0.152673,"In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gaetano M', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology Città della Salute e della Scienza, Department of Medical Sciences, University of Torino, Turin, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Medicine, Cardiology and Intensive Care Medicine and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Santa Cruz, Lisbon, Portugal.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.0882']
1811,32432718,Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial.,"Importance


Female sex has been identified as a risk factor for bleeding after percutaneous coronary intervention (PCI) and may have contributed to the underuse of drug-eluting stents in women. This risk may be further enhanced among patients with a high bleeding risk.
Objective


To assess the 2-year outcomes by sex in patients with a high bleeding risk who were enrolled in the LEADERS FREE trial.
Design, Setting, and Participants


This cohort study is a prespecified, sex-based secondary analysis of the LEADERS FREE double-blind, randomized clinical trial that was conducted at 68 sites in 20 countries from December 2012 to May 2014. Patients with a high bleeding risk who underwent PCI and met the trial eligibility criteria were enrolled at the participating sites and followed up for up to 2 years.
Interventions


Patients were randomized 1:1 to either a bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy.
Main Outcomes and Measures


The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target lesion revascularization. Bleeding was assessed using the Bleeding Academic Research Consortium (BARC) scale, and the source of bleeding was recorded.
Results


A total of 2432 patients with a high bleeding risk were included in the study. Of these patients, the mean (SD) age was 75 (9) years, and 1694 (69.7%) were men and 738 (30.3%) were women. Women and men had similar incidence of the 2-year primary safety (14.7% vs 13.6%; P = .37) and efficacy (9.2% vs 9.5%; P = .70) end points. The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization (women: 6.3% vs 12.1%; men: 7.0% vs 12.0%; P for interaction = .70) and similar rates of the primary safety end point (women: 12.4% vs 17.0%; men: 12.6% vs 14.5%; P for interaction = .40). Overall, 2-year BARC types 3 to 5 major bleeding (10.2% vs 8.6%; P = .14) was not statistically different between the sexes, but women experienced greater BARC types 3 to 5 major bleeding within the first 30 days (5.1% vs 2.4%; P = .007) and greater vascular access site major bleeding than men (2.2% vs 0.5%; P < .001). In both sexes, vascular (women: hazard ratio [HR], 3.45 [95% CI, 1.51-7.87]; men: HR, 4.14 [95% CI, 1.33-12.95]) and nonvascular major bleeding (women: HR, 3.76 [95% CI, 2.17- 6.53]; men: HR, 4.62 [95% CI, 3.23-6.61]) were associated with greater 2-year mortality.
Conclusions and Relevance


This study found no sex differences in the ischemic outcomes of patients with a high bleeding risk after PCI, but women appeared to demonstrate greater early bleeding and major bleeding from the vascular access site. Both women and men with major bleeding seemed to experience worse 2-year mortality, suggesting that bleeding avoidance strategies should be uniformly adopted for all patients, with close attention dedicated to women to avoid denying them the benefits of PCI.
Trial Registration


ClinicalTrials.gov Identifier: NCT02843633.",2020,"The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization","['Patients with a high bleeding risk who underwent PCI and met the trial eligibility criteria were enrolled at the participating sites and followed up for up to 2 years', 'patients with a high bleeding risk', 'patients with a high bleeding risk who were enrolled in the LEADERS FREE trial', 'Patients With a High Bleeding Risk', 'Of these patients, the mean (SD) age was 75 (9) years, and 1694 (69.7%) were men and 738 (30.3%) were women', '2432 patients with a high bleeding risk were included in the study', 'patients with a high bleeding risk after PCI, but women', '68 sites in 20 countries from December 2012 to May 2014']","['Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy', 'bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy']","['2-year mortality', '2-year primary safety', 'composite of cardiac death, myocardial infarction, or stent thrombosis', 'nonvascular major bleeding', 'Bleeding', 'clinically driven target lesion revascularization', 'vascular access site major bleeding', 'Overall, 2-year BARC types 3 to 5 major bleeding', 'efficacy', 'early bleeding and major bleeding', 'Bleeding Academic Research Consortium (BARC) scale, and the source of bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C1445093', 'cui_str': 'Drug coated stent'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449416', 'cui_str': 'Source'}]",2432.0,0.123116,"The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization","[{'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Hôpital de la Tour, Geneva, Switzerland.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Windhoevel', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center INSERM U 970, Paris Descartes University, Paris, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Copt', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.0285']
1812,30346913,Noninvasive Brain Stimulation over the M1 Enhances Bimanual Force Control Ability: A Randomized Double-Blind Sham-Controlled Study.,"Well-coordinated bimanual force control is common in daily life. We investigated the effects of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex on bimanual force control. Under a cross-over study, young adults ( n  = 19; female = 6, male = 13) completed three bimanual force control tasks at 5%, 25%, and 50% of bimanual maximum voluntary force (BMVF) before and after real or sham tDCS. Real tDCS enhanced accuracy at all BMVF, reduced variability at 5% BMVF, and increased coordination at 5% BMVF. Real tDCS improved force control at 5% and 25% BMVF, and especially increased bimanual coordination at 5% BMVF. These findings might have implications for establishing interventions for patients with hand force control deficits.",2019,"Real tDCS improved force control at 5% and 25% BMVF, and especially increased bimanual coordination at 5% BMVF.","['patients with hand force control deficits', 'young adults ( n  = 19; female = 6, male = 13']","['anodal transcranial direct current stimulation (tDCS', 'bimanual maximum voluntary force (BMVF) before and after real or sham tDCS']","['bimanual coordination', 'Real tDCS improved force control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.178808,"Real tDCS improved force control at 5% and 25% BMVF, and especially increased bimanual coordination at 5% BMVF.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'a Major in Rehabilitation Science, Graduate School , Korea University , Seoul , Korea .'}, {'ForeName': 'Jaehyuk', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'a Major in Rehabilitation Science, Graduate School , Korea University , Seoul , Korea .'}, {'ForeName': 'Sejun', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'a Major in Rehabilitation Science, Graduate School , Korea University , Seoul , Korea .'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Celeste Flores Gimenez', 'Affiliation': 'a Major in Rehabilitation Science, Graduate School , Korea University , Seoul , Korea .'}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'a Major in Rehabilitation Science, Graduate School , Korea University , Seoul , Korea .'}]",Journal of motor behavior,['10.1080/00222895.2018.1523784']
1813,32434467,Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial.,"BACKGROUND


Unhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use.
METHODS AND ANALYSIS


We are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation.
DISCUSSION


This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach.
TRIAL REGISTRATION


ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.",2020,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.",['One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged'],['Medication assisted therapy (MAT'],['health outcomes'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0890021,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.","[{'ForeName': 'Alison N', 'Initials': 'AN', 'LastName': 'Huffstetler', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA. Alison.huffstetler@vcuhealth.org.'}, {'ForeName': 'Anton J', 'Initials': 'AJ', 'LastName': 'Kuzel', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'E Marshall', 'Initials': 'EM', 'LastName': 'Brooks', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Lail Kashiri', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Villalobos', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Svikis', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Bortz', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Epling', 'Affiliation': 'Department of Family and Community Medicine, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Parchman', 'Affiliation': 'MacColl Center, Kaiser Permanente of Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Shenandoah Valley Family Practice Residency, Virginia Commonwealth University, Front Royal, VA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wessler', 'Affiliation': 'Riverside Family Medicine Residency, Virginia Commonwealth University, Newport News, VA, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Yu', 'Affiliation': 'St. Francis Family Medicine Residency, Virginia Commonwealth University, Midlothian, VA, USA.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}]",BMC family practice,['10.1186/s12875-020-01147-4']
1814,32434470,"GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope for double lumen endotracheal intubation in patients with predicted normal airways: a randomized, controlled, prospective trial.","BACKGROUND


The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. We wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation.
METHODS


This was a randomized, controlled, prospective study. We randomly allocated 90 adult patients with predicted normal airways into three groups. All patients underwent routine anesthesia using different laryngoscopes according to group allocation. We compared DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications. All outcomes were analyzed using SPSS13.0.
RESULTS


Compared with the GlideScope, the Macintosh gave shorter times for DLT insertion (median: 96 (IQR: 51 [min-max: 62-376] s vs 73 (26 [48-419] s, p = 0.003); however, there was no difference between the Macintosh and C-MAC(D) (p = 0.610). The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D) (p = 0.001, p = 0.028, respectively). NRS of DLT delivery and insertion were significantly lower in the Macintosh than in the others (p < 0.001). However, the C/L degree in the Macintosh was significantly higher than in the others (p < 0.001). The incidences of oral bleeding, hoarseness, sore throat and dental trauma were low in all groups (p > 0.05). There were no significant differences in DLT misplacement, fiberoptic time or hemodynamic changes among the groups.
CONCLUSIONS


Compared with the Macintosh laryngoscope, the GlideScope® and C-MAC®(D) videolaryngoscopes may not be recommended as the first choice for routine DLT intubation in patients with predicted normal airways.
TRIAL REGISTRATION


The study was prospectively registered at the Chinese Clinical Trial Registry (no. ChiCTR1900025718); principal investigator: Z.L.H.; date of registration: September 6, 2019.",2020,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"['90 adult patients with predicted normal airways into three groups', 'patients with predicted normal airways']","['C-MAC®(D', 'routine anesthesia', 'GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope', 'double lumen endotracheal tube (DLT']","['incidences of oral bleeding, hoarseness, sore throat and dental trauma', 'DLT misplacement, fiberoptic time or hemodynamic changes', 'DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications', 'NRS of DLT delivery and insertion', 'successful first attempt rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C1301685', 'cui_str': 'Dental trauma'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",90.0,0.0618911,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Renlong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Hang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Shanjuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Shanjuanwang@shsmu.edu.cn.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Zhenlinghuang@shsmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-020-01012-y']
1815,31366999,The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.,"BACKGROUND


Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women.
METHODS


Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes.
RESULTS


Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective.
CONCLUSIONS


The programmes were equally effective for weight control, but the community programme had additional benefits.
CLINICAL TRIAL REGISTRATION


ISRCTN68576140.",2019,Both programmes reduced weight and body fat: home vs. control,"['overweight or obese women and prevent gains in normal-weight women', 'Forty-three percent of eligible women were recruited', 'Overweight or obese (n\u2009=\u2009243) and normal weight (n\u2009', '166) women', 'breast cancer diagnosis']","['home versus community-based weight control programmes', 'supervised community weight control programme (community) or to standard written advice (control']","['change in weight and body fat', 'acceptability and effectiveness', 'change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes', 'physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective', 'weight and body fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.108066,Both programmes reduced weight and body fat: home vs. control,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'McMullan', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Applied Sciences, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanora', 'Initials': 'E', 'LastName': 'Lovato', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Clinical Radiology, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Speed', 'Affiliation': 'The School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}]",British journal of cancer,['10.1038/s41416-019-0522-6']
1816,31515507,Impact of low-intensity resistance and whole-body vibration training on aortic hemodynamics and vascular function in postmenopausal women.,"To examine the effects of low-intensity resistance exercise training (LIRET) and whole-body vibration training (WBVT) with an external weighted vest on arterial stiffness, wave reflection, brachial flow-mediated dilation (FMD), and physical performance in postmenopausal women. Thirty-three postmenopausal women were stratified by age, body mass index (BMI), and maximal voluntary contraction (MVC) (age, 65 ± 4 years; BMI, 23.3 ± 2.6 kg/m 2 ; MVC, 17.4 ± 2.6 kg) and randomized into LIRET, WBVT, or a nonexercising control group for 12 weeks. Arterial stiffness, augmentation index (AIx), augmented pressure (AP), brachial FMD, gait speed and leg strength were measured at baseline and 12 weeks. WBVT induced improvements in pulse pressure amplification (PPA) (0.04 ± 0.02) compared to control (P = 0.048) and in wave reflection indices [AIx (-4.3 ± 1.4%) and AP (-2.9 ± 1.3 mmHg)] compared to LIRET (P = 0.039 and 0.048, respectively). WBVT (3.8 ± 1.4%) and LIRET (5.0 ± 1.5%) induced similar improvements in FMD compared to control (P = 0.029 and 0.008, respectively). WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group. LIRET significantly increased gait speed compared to WBVT (P = 0.043). Although both WBVT and LIRET increased brachial artery FMD (systemic effect), WBVT seemed to be more efficacious in improving wave reflection and cardiac pulsatile load. Interestingly, LIRET elicited a significant improvement in gait speed. Both modalities seem effective in improving systemic endothelial function and muscle strength in postmenopausal women.",2019,"WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group.","['Thirty-three postmenopausal women were stratified by age, body mass index (BMI), and maximal voluntary contraction (MVC) (age, 65\u2009±\u20094 years; BMI, 23.3\u2009±\u20092.6\u2009kg/m 2 ; MVC, 17.4\u2009±\u20092.6\u2009kg) and randomized into', 'postmenopausal women']","['WBVT and LIRET', 'LIRET, WBVT, or a nonexercising control', 'WBVT', 'low-intensity resistance and whole-body vibration training', 'low-intensity resistance exercise training (LIRET) and whole-body vibration training (WBVT) with an external weighted vest']","['FMD', 'wave reflection indices', 'systemic endothelial function and muscle strength', 'brachial artery FMD (systemic effect), WBVT', 'aortic hemodynamics and vascular function', 'gait speed', 'arterial stiffness, wave reflection, brachial flow-mediated dilation (FMD), and physical performance', 'pulse pressure amplification (PPA', 'leg strength', 'WBVT', 'Arterial stiffness, augmentation index (AIx), augmented pressure (AP), brachial FMD, gait speed and leg strength']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0453884', 'cui_str': 'Waistcoat'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2607857'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",33.0,0.0185631,"WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group.","[{'ForeName': 'Salvador J', 'Initials': 'SJ', 'LastName': 'Jaime', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI, 54601, USA. sjaime@uwlax.edu.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Alvarez-Alvarado', 'Affiliation': 'Florida State University, 1114W Call St, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX, 79409, USA.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0328-1']
1817,31515667,A prospective phase I multicentre randomized cross-over pharmacokinetic study to determine the effect of food on abiraterone pharmacokinetics.,"PURPOSE


Abiraterone acetate is used at a fixed oral dose of 1000 mg once daily (OD) taken fasted. By administering abiraterone acetate with food, a reduced dose can potentially be given while maintaining equivalent abiraterone exposure. Moreover, administering abiraterone acetate with a breakfast is considered more patient friendly. The aim of this study was to establish the bio-equivalent lower dose of abiraterone when taken with a continental breakfast (CB) compared to the standard intake of 1000 mg OD fasted.
METHODS


In this phase I, randomized cross-over, multi-center study, abiraterone pharmacokinetics (PK) were evaluated in patients with metastatic castration-resistant prostate cancer who were treated for 14 days with 1000 mg abiraterone acetate taken fasted, followed by 14 days of treatment with 500 mg taken with a CB.
RESULTS


14 patients were enrolled into the study, of whom 12 were eligible for PK analysis. The geometric mean ratio (GMR) (fed/fasted) was 0.88 (90% CI 0.73-1.07) for area-under-the-curve (AUC 0-24h ), 1.03 (90% CI 0.79-1.34) for C max  and 0.81 (90% CI 0.60-1.10) for C trough , respectively. High inter-patient variability (> 50%) was found for all PK parameters under both intake conditions. Patients seemed to be slightly more satisfied about the intake of 500 mg abiraterone acetate when taken with a CB compared to 1000 mg fasted.
CONCLUSION


In conclusion, a bioequivalent lower dose of abiraterone taken with food could not be established in our study. Although based on the absence of a exposure-toxicity relationship, the strict bioequivalence margins as defined by the FDA guidelines could be applied more flexible for abiraterone. Information on the effect of food on abiraterone pharmacokinetics as presented in our study can be used for patients with difficulties taken their medication fasted.",2019,The geometric mean ratio (GMR) (fed/fasted) was 0.88,"['patients with difficulties taken their medication fasted', '14 patients were enrolled into the study, of whom 12 were eligible for PK analysis', 'patients with metastatic castration-resistant prostate cancer who were treated for 14\xa0days with 1000\xa0mg']","['continental breakfast (CB', 'Abiraterone acetate', 'abiraterone acetate', 'abiraterone pharmacokinetics (PK', 'abiraterone']",['geometric mean ratio (GMR'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0736296,The geometric mean ratio (GMR) (fed/fasted) was 0.88,"[{'ForeName': 'Floor J E', 'Initials': 'FJE', 'LastName': 'Lubberman', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Guillemette E', 'Initials': 'GE', 'LastName': 'Benoist', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Winald', 'Initials': 'W', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hamberg', 'Affiliation': 'Department of Medical Oncology, Franciscus Gasthuis and Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van Oort', 'Affiliation': 'Department of Urology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Nielka P', 'Initials': 'NP', 'LastName': 'van Erp', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. nielka.vanerp@radboudumc.nl.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03952-w']
1818,31501078,Reducing Pain and Fear in Children During Venipuncture: A Randomized Controlled Study.,"BACKGROUND


Venous blood sampling is a common procedure in the hospital setting and cause significant pain and stress for children.
AIM


This study was conducted to determine and compare the effects of balloon inflation, ball squeezing, and coughing methods on levels of pain and fear during venipuncture in children aged 7-12 years.
DESIGN


Experimental, randomized controlled study.
SETTING


The study was conducted at a state hospital in Turkey between March and July 2017.
PARTICIPANTS/SUBJECTS


The study population comprised children 7-12 years of age who were subjected to venous blood sampling in the phlebotomy unit of a state hospital. The study sample included 120 children for a confidence interval of 95% and statistical power of 80%.
METHODS


The children were assigned to one of four groups (balloon inflation, ball squeezing, coughing, and control groups), each including 30 participants. The children's pain and fear were rated before and after the procedure by the children themselves, their parents, and a researcher using the Wong-Baker FACES Pain Rating Scale and Children's Fear Scale, respectively.
RESULTS


Mean scores for pain and fear after the procedure were lower in all intervention groups compared with the control group (p = .001). There was no statistical difference in pain or fear scores between the intervention groups; however, the children in the coughing group had the lowest scores for both pain and fear.
CONCLUSION


Balloon inflation, ball squeezing, and coughing were all effective in reducing pain and fear associated with venipuncture in children aged 7-12 years. These are simple, rapid, and cost-effective methods that nurses can implement during venipuncture with minimal equipment and preparation.",2020,"There was no statistical difference in pain or fear scores between the intervention groups; however, the children in the coughing group had the lowest scores for both pain and fear.
","['120 children for a confidence interval of 95% and statistical power of 80', 'Children', 'children aged 7-12\xa0years', 'The study was conducted at a state hospital in Turkey between March and July\xa02017', 'The study population comprised children 7-12\xa0years of age who were subjected to venous blood sampling in the phlebotomy unit of a state hospital']","['Venipuncture', 'balloon inflation, ball squeezing, and coughing methods']","['pain or fear scores', 'Mean scores for pain and fear', 'pain and fear associated with venipuncture', ""Baker FACES Pain Rating Scale and Children's Fear Scale"", 'Pain and Fear', 'pain and fear']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020026', 'cui_str': 'Hospitals, State'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",120.0,0.0558702,"There was no statistical difference in pain or fear scores between the intervention groups; however, the children in the coughing group had the lowest scores for both pain and fear.
","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Aykanat Girgin', 'Affiliation': 'Sağlık Bilimleri University, Hamidiye Nursing Faculty, İstanbul, Turkey.'}, {'ForeName': 'İlknur', 'Initials': 'İ', 'LastName': 'Göl', 'Affiliation': 'Çankırı Karatekin University, Faculty of Health Sciences, Çankırı, Turkey. Electronic address: ilknurnayirgol@gmail.com.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.07.006']
1819,32435764,Clinical Performance of a Glass-Hybrid System Compared with a Resin Composite in the Posterior Region: Results of a 2-year Multicenter Study.,"PURPOSE


To compare the clinical performance of a glass hybrid restorative system, EQUIA Forte, with that of a nanohybrid resin composite, Tetric EvoCeram, in two-surface class II cavities.
MATERIALS AND METHODS


This multicenter, randomized controlled clinical study was conducted at four different dental schools. In total, 360 restorations were placed in patients in need of two class-II, two-surface restorations in the molar region of the same jaw. Each patient received one glass hybrid restoration (EQUIA Forte, GC) and one resin composite restoration (Tetric EvoCeram, Ivoclar Vivadent). Two independent evaluators performed a clinical evaluation of each site after 1 week (baseline), 1 year, and 2 years using the criteria of the FDI World Dental Federation (FDI-2).
RESULTS


The estimated survival rates at the 2-year recall were 93.6% and 94.5% for EQUIA Forte and Tetric EvoCeram, respectively. There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
CONCLUSION


Both the glass-hybrid restorative system and nanohybrid resin composite showed good clinical performance in moderate to large two-surface class II restorations in a 2-year follow-up.",2020,"There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
","['four different dental schools', 'In total, 360 restorations were placed in patients in need of two class-II, two-surface restorations in the molar region of the same jaw']","['glass hybrid restorative system, EQUIA Forte', 'Glass-Hybrid System Compared with a Resin Composite', 'glass hybrid restoration (EQUIA Forte, GC) and one resin composite restoration (Tetric EvoCeram, Ivoclar Vivadent']","['good clinical performance', 'evaluated esthetic, functional or biological properties', 'survival rates', 'estimated survival rates']","[{'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1570772', 'cui_str': 'Tetric EvoCeram'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",360.0,0.0596878,"There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Miletić', 'Affiliation': ''}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Baraba', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Pulcini', 'Affiliation': ''}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Marković', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Perić', 'Affiliation': ''}, {'ForeName': 'Cigdem Atalayin', 'Initials': 'CA', 'LastName': 'Ozkaya', 'Affiliation': ''}, {'ForeName': 'Lezize Sebnem', 'Initials': 'LS', 'LastName': 'Turkun', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44547']
1820,15629023,Argon laser photo-coagulation complications in diabetic retinopathy.,"Diabetic retinopathy is a disease based on vascular genesis that begins as microangiopathy and develops into macroangioapthy preceded by fibroproliferation changes. According to histo- pathological changes, diabetic retinopathy is divided into nonproliferative, pre-proliferative and proliferative diabetic retinopathy. Possibilities and needs for photo-coagulation in the earlier and later changes in retina reduce the meaning of conservative treatment. Laser photo-coagulation with therapeutical may cause unwanted and damaging effects, as well. Complications diagnosed in diabetic retinopathy, such as cataract, secondary glaucoma, central retinal vein thrombosis, haemophthalmus, are much more frequent in patients with laser photo-coagulation treatment.",2004,"Complications diagnosed in diabetic retinopathy, such as cataract, secondary glaucoma, central retinal vein thrombosis, haemophthalmus, are much more frequent in patients with laser photo-coagulation treatment.","['patients with laser photo-coagulation treatment', 'diabetic retinopathy']",['Argon laser photo-coagulation complications'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0392247', 'cui_str': 'Argon Ion Lasers'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",[],,0.0213661,"Complications diagnosed in diabetic retinopathy, such as cataract, secondary glaucoma, central retinal vein thrombosis, haemophthalmus, are much more frequent in patients with laser photo-coagulation treatment.","[{'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Pavljasević', 'Affiliation': 'Department of Ophthalmology, University School of Medicine Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Nurka', 'Initials': 'N', 'LastName': 'Pranjić', 'Affiliation': ''}, {'ForeName': 'Dzevdet', 'Initials': 'D', 'LastName': 'Sarajlić', 'Affiliation': ''}]",Bosnian journal of basic medical sciences,[]
1821,32011717,Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial.,"OBJECTIVES


Minimally invasive extracorporeal circulation (MiECC) is suggested to have favourable impact on blood loss compared to conventional extracorporeal circulation. We aimed to compare the impact of both systems on coagulation.
METHODS


Randomized trial comparing endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC group (n = 30) or conventional extracorporeal circulation group (n = 30). Secondary outcomes were in vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up.
RESULTS


Compared to the conventional extracorporeal circulation group, the MiECC group showed (i) a trend towards a higher early postoperative endogenous thrombin-generating potential (P = 0.06), (ii) lower intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1 + 2 (P < 0.001), (iii) less haemodilution early postoperatively as measured by haematocrit and weight gain, but without correlation to coagulation factors or bleeding end points. Moreover, half as many patients required postoperative blood transfusion in the MiECC group (17% vs 37%, P = 0.14), although postoperative blood loss did not differ between groups (P = 0.84). Thrombin-antithrombin complex levels (rs = 0.36, P = 0.005) and prothrombin fragment 1 + 2 (rs = 0.45, P < 0.001), but not early postoperative endogenous thrombin-generating potential (rs = 0.05, P = 0.72), showed significant correlation to increased transfusion requirements. The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively. Perioperative morbidity and 30-day mortality did not differ between groups.
CONCLUSIONS


Conventional but not MiECC is associated with significant intraoperative thrombin generation despite full heparinization. No correlation between coagulation factors or bleeding end points with the degree of haemodilution could be ascertained.
CLINICALTRIALS.GOV IDENTIFIER


NCT03216720.",2020,"The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively.",[],"['endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC', 'MiECC', 'Minimally invasive extracorporeal circulation (MiECC', 'minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['postoperative blood loss', 'Thrombin-antithrombin complex levels', 'Perioperative morbidity and 30-day mortality', 'vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up', 'haematocrit and weight gain', 'intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1\u2009+\u20092', 'transfusion requirements', 'postoperative blood transfusion', 'blood loss', 'levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis']",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}]",,0.0676663,"The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively.","[{'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Debbie Richards', 'Initials': 'DR', 'LastName': 'Halle', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Per Hostrup', 'Initials': 'PH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hans Henrik', 'Initials': 'HH', 'LastName': 'Kimose', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jacob Raben', 'Initials': 'JR', 'LastName': 'Greisen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kremke', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa010']
1822,31774411,Mechanisms and Effects of a WeChat-Based Intervention on Suicide Among People Living With HIV and Depression: Path Model Analysis of a Randomized Controlled Trial.,"BACKGROUND


People living with HIV and depression have high rates of suicide. Studies of mobile health (mHealth) interventions have shown feasibility, acceptability, and efficacy in improving mental health in people living with HIV and depression. However, few studies have examined the mechanisms and effects of mHealth interventions on suicide.
OBJECTIVE


This study was designed to examine the mechanisms and effects of a WeChat-based intervention, Run4Love, on suicide among people living with HIV and depression in China, while considering perceived stress and depressive symptoms as mediators.
METHODS


A sample of 300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital and was randomized to the Run4Love group or a control group. Data were collected at baseline, 3-, 6-, and 9-month follow-ups. Path analysis modeling, with longitudinal data, was used in data analyses.
RESULTS


The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001). A partial mediating effect between perceived stress and depressive symptoms accounted for 33% (-0.09/-0.27) of the total effect.
CONCLUSIONS


Through path analyses, we understood the mechanisms and effects of an mHealth intervention on suicide prevention. The findings underscored the importance of stress reduction and depression treatment in such a program. We call for more effective suicide prevention, especially mHealth interventions targeting the vulnerable population of people living with HIV and depression.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showprojen.aspx?proj=21019.",2019,"The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001).","['people living with HIV and depression', '300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital', 'people living with HIV and depression in China', 'People Living With HIV and Depression']","['WeChat-Based Intervention', 'WeChat-based intervention, Run4Love', 'mobile health (mHealth) interventions', 'mHealth intervention']","['suicide rate', 'perceived stress and depressive symptoms', 'stress and depressive symptoms', 'Suicide']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",300.0,0.122319,"The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001).","[{'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}]",Journal of medical Internet research,['10.2196/14729']
1823,31902148,Letter: Comparison of the Efficacy of Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy on Lipid Parameters in Patients with Type 2 Diabetes Mellitus ( Diabetes Metab J  2019;43:582-9).,,2019,,['Patients with Type 2 Diabetes Mellitus ( Diabetes Metab J  2019;43:582-9'],['Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy'],['Lipid Parameters'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0116797,,"[{'ForeName': 'Tae Seo', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. imsts@catholic.ac.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0205']
1824,31320111,Effect of a saline flush technique for head and neck imaging in dual-energy CT: improvement of image quality and perivenous artefact reduction using virtual monochromatic imaging.,"AIM


To evaluate the effect of the saline flush (SF) technique on the depiction of lesions and the reduction of perivenous artefacts in the head and neck region using dual-energy computed tomography (CT) with virtual monochromatic imaging (VMI).
MATERIALS AND METHODS


Fifty patients with head and neck cancer were divided into two groups: group A, without a SF and group B, with a 30-ml SF. All images were acquired using fast kilovolt-switching CT (Revolution HD, GE Healthcare, Milwaukee, WI, USA). Contrast-to-noise ratios (CNRs) of the lesions were calculated at VMI energy levels ranging from 40 to 80 keV. Subjective analysis of overall image quality, delineation of lesions, and perivenous artefacts was conducted by two reviewers at both VMI energy level 40 keV and the optimal energy level (which showed optimal CNR by objective analysis).
RESULTS


Optimal energy level was 63 keV for group A and 61 keV for group B. At VMI energy levels ranging from 40 to 80 keV, the CNR was higher for group B. The highest subjective overall image quality was shown for group B at the optimal energy level (subjective image quality mean value, 3.40). Subjective delineation of lesions was comparable. The perivenous artefact score was significantly higher for group B (2.44 versus 2.74 [p<0.05] at 40 keV, 3.20 versus 3.46 [p<0.05] at the optimal energy level).
CONCLUSION


The SF technique results in an improvement of lesion CNR and a reduction of perivenous artefacts in VMI using duel-energy CT, especially at 40 keV.",2019,"The perivenous artefact score was significantly higher for group B (2.44 versus 2.74 [p<0.05] at 40 keV, 3.20 versus 3.46 [p<0.05] at the optimal energy level).
",['Fifty patients with head and neck cancer'],"['saline flush technique', 'dual-energy computed tomography (CT) with virtual monochromatic imaging (VMI', 'saline flush (SF) technique']","['perivenous artefact score', 'highest subjective overall image quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C4055114', 'cui_str': 'Dual energy computed tomography (procedure)'}, {'cui': 'C0205290', 'cui_str': 'Monochromatic (qualifier value)'}]","[{'cui': 'C0085089', 'cui_str': 'Artifacts'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",50.0,0.0256155,"The perivenous artefact score was significantly higher for group B (2.44 versus 2.74 [p<0.05] at 40 keV, 3.20 versus 3.46 [p<0.05] at the optimal energy level).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Washio', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ohira', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan; Department of Medical Physics and Engineering, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: ueyama-si@mc.pref.osaka.jp.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kanayama', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karino', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Komiyama', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Teshima', 'Affiliation': 'Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.'}]",Clinical radiology,['10.1016/j.crad.2019.06.010']
1825,28917549,A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults.,"BACKGROUND


Hypoxemia and hypotension are common complications during endotracheal intubation of critically ill adults. Verbal performance of a written, preintubation checklist may prevent these complications. We compared a written, verbally performed, preintubation checklist with usual care regarding lowest arterial oxygen saturation or lowest systolic BP experienced by critically ill adults undergoing endotracheal intubation.
METHODS


A multicenter trial in which 262 adults undergoing endotracheal intubation were randomized to a written, verbally performed, preintubation checklist (checklist) or no preintubation checklist (usual care). The coprimary outcomes were lowest arterial oxygen saturation and lowest systolic BP between the time of procedural medication administration and 2 min after endotracheal intubation.
RESULTS


The median lowest arterial oxygen saturation was 92% (interquartile range [IQR], 79-98) in the checklist group vs 93% (IQR, 84-100) with usual care (P = .34). The median lowest systolic BP was 112 mm Hg (IQR, 94-133) in the checklist group vs 108 mm Hg (IQR, 90-132) in the usual care group (P = .61). There was no difference between the checklist and usual care in procedure duration (120 vs 118 s; P = .49), number of laryngoscopy attempts (one vs one attempt; P = .42), or severe life-threatening procedural complications (40.8% vs 32.6%; P = .20).
CONCLUSIONS


The verbal performance of a written, preprocedure checklist does not increase the lowest arterial oxygen saturation or lowest systolic BP during endotracheal intubation of critically ill adults compared with usual care.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02497729; URL: www.clinicaltrials.gov.",2018,"There was no difference between the checklist and usual care in procedure duration (120 vs 118 s; P = .49), number of laryngoscopy attempts (one vs one attempt; P = .42), or severe life-threatening procedural complications (40.8% vs 32.6%; P = .20).
","['262 adults undergoing endotracheal intubation', 'critically ill adults undergoing endotracheal intubation', 'Critically Ill Adults', 'critically ill adults']","['preintubation checklist (checklist) or no preintubation checklist (usual care', 'Endotracheal Intubation', 'written, verbally performed, preintubation checklist with usual care regarding lowest arterial oxygen saturation or lowest systolic BP']","['checklist and usual care in procedure duration', 'Verbal performance', 'lowest arterial oxygen saturation and lowest systolic BP between the time of procedural medication administration and 2\xa0min after endotracheal intubation', 'median lowest arterial oxygen saturation', 'median lowest systolic BP', 'severe life-threatening procedural complications', 'lowest arterial oxygen saturation or lowest systolic BP', 'number of laryngoscopy attempts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]",262.0,0.151669,"There was no difference between the checklist and usual care in procedure duration (120 vs 118 s; P = .49), number of laryngoscopy attempts (one vs one attempt; P = .42), or severe life-threatening procedural complications (40.8% vs 32.6%; P = .20).
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA. Electronic address: djanz@lsuhsc.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lentz', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Bennett P', 'Initials': 'BP', 'LastName': 'deBoisblanc', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA.'}, {'ForeName': 'Yasin A', 'Initials': 'YA', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA.'}, {'ForeName': 'Jairo I', 'Initials': 'JI', 'LastName': 'Santanilla', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA; Department of Medicine, Section of Emergency Medicine, Louisiana State University School of Medicine New Orleans, New Orleans, LA; Department of Pulmonary and Critical Care Medicine, Ochsner Health System New Orleans, New Orleans, LA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2017.08.1163']
1826,31774408,"A Chatbot Versus Physicians to Provide Information for Patients With Breast Cancer: Blind, Randomized Controlled Noninferiority Trial.","BACKGROUND


The data regarding the use of conversational agents in oncology are scarce.
OBJECTIVE


The aim of this study was to verify whether an artificial conversational agent was able to provide answers to patients with breast cancer with a level of satisfaction similar to the answers given by a group of physicians.
METHODS


This study is a blind, noninferiority randomized controlled trial that compared the information given by the chatbot, Vik, with that given by a multidisciplinary group of physicians to patients with breast cancer. Patients were women with breast cancer in treatment or in remission. The European Organisation for Research and Treatment of Cancer Quality of Life Group information questionnaire (EORTC QLQ-INFO25) was adapted and used to compare the quality of the information provided to patients by the physician or the chatbot. The primary outcome was to show that the answers given by the Vik chatbot to common questions asked by patients with breast cancer about their therapy management are at least as satisfying as answers given by a multidisciplinary medical committee by comparing the success rate in each group (defined by a score above 3). The secondary objective was to compare the average scores obtained by the chatbot and physicians for each INFO25 item.
RESULTS


A total of 142 patients were included and randomized into two groups of 71. They were all female with a mean age of 42 years (SD 19). The success rates (as defined by a score >3) was 69% (49/71) in the chatbot group versus 64% (46/71) in the physicians group. The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
CONCLUSIONS


This is the first study that assessed an artificial conversational agent used to inform patients with cancer. The EORTC INFO25 scores from the chatbot were found to be noninferior to the scores of the physicians. Artificial conversational agents may save patients with minor health concerns from a visit to the doctor. This could allow clinicians to spend more time to treat patients who need a consultation the most.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03556813, https://tinyurl.com/rgtlehq.",2019,"The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
","['Patients', 'Patients were women with breast cancer in treatment or in remission', 'patients with breast cancer with a level of satisfaction similar to the answers given by a group of physicians', 'patients with cancer', 'With Breast Cancer', 'patients with breast cancer', 'A total of 142 patients', 'They were all female with a mean age of 42 years (SD 19']","['EORTC INFO25', 'artificial conversational agent', 'Artificial conversational agents']","['success rate', 'success rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",[],142.0,0.0746725,"The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
","[{'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Bibault', 'Affiliation': 'Department of Radiation Oncology, Hôpital Européen Georges Pompidou, AP-HP, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaix', 'Affiliation': 'ENT Department, Hôpital Gui de Chauliac, Université Montpellier 1, Montpellier, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Guillemassé', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cousin', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Escande', 'Affiliation': 'Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Perrin', 'Affiliation': 'Department of Gynecological Oncologic Surgery, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Pienkowski', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Delamon', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nectoux', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Brouard', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}]",Journal of medical Internet research,['10.2196/15787']
1827,31468528,Randomized controlled trial of a web-based Acceptance and Commitment Therapy (ACT) program to promote mental health in university students.,"OBJECTIVE


This study evaluated a 4-week web-based Acceptance and Commitment Therapy (ACT) mental health promotion intervention for university students.
METHOD


Participants were randomized to intervention (n = 596) or waitlist control (n = 566). Assessment of primary outcomes (depression, anxiety, stress, well-being, self-compassion, life satisfaction, and academic performance) and ACT processes (acceptance, cognitive fusion, education values, valued living, and present moment awareness) occurred at pre- and post-intervention and 12-week follow-up for intervention participants, and the same pre-post interval for waitlist control participants.
RESULTS


Analyses showed significant improvements from pre- to post-intervention compared with waitlist control on all primary outcomes and ACT processes. All intervention gains were maintained at follow-up. Improvements on all primary outcomes were mediated by three or more ACT processes in both samples. Intervention effects were consistent across both sample groupings.
CONCLUSION


Findings provide support for a web-based ACT mental health promotion intervention for university students.",2020,"RESULTS


Analyses showed significant improvements from pre- to post-intervention compared with waitlist control on all primary outcomes and ACT processes.","['university students', 'Participants were randomized to intervention (n\u2009=\u2009596) or']","['web-based Acceptance and Commitment Therapy (ACT) program', 'waitlist control', '4-week web-based Acceptance and Commitment Therapy (ACT) mental health promotion intervention']","['primary outcomes (depression, anxiety, stress, well-being, self-compassion, life satisfaction, and academic performance) and ACT processes (acceptance, cognitive fusion, education values, valued living, and present moment awareness']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",596.0,0.0836068,"RESULTS


Analyses showed significant improvements from pre- to post-intervention compared with waitlist control on all primary outcomes and ACT processes.","[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Viskovich', 'Affiliation': 'Doctor of Philosophy, School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kenneth Ian', 'Initials': 'KI', 'LastName': 'Pakenham', 'Affiliation': 'Professor of Clinical and Health Psychology, School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of clinical psychology,['10.1002/jclp.22848']
1828,31505002,Perceptions of uncertainties about carrier results identified by exome sequencing in a randomized controlled trial.,"How individuals perceive uncertainties in sequencing results may affect their clinical utility. The purpose of this study was to explore perceptions of uncertainties in carrier results and how they relate to psychological well-being and health behavior. Post-reproductive adults (N = 462) were randomized to receive carrier results from sequencing through either a web platform or a genetic counselor. On average, participants received two results. Group differences in affective, evaluative, and clinical uncertainties were assessed from baseline to 1 and 6 months; associations with test-specific distress and communication of results were assessed at 6 months. Reductions in affective uncertainty (∆x̅ = 0.78, 95% CI: 0.53, 1.02) and evaluative uncertainty (∆x̅ = 0.69, 95% CI: 0.51, 0.87) followed receipt of results regardless of randomization arm at 1 month. Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform. Evaluative uncertainty was associated with a lower likelihood of communicating results to health care providers. Clinical uncertainty was associated with a lower likelihood of communicating results to children. Learning one's carrier results may reduce perceptions of uncertainties, though web-based return may lead to less reduction in clinical uncertainty in the short term. These findings warrant reinforcement of clinical implications to minimize residual questions and promote appropriate health behavior (communicating results to at-risk relatives in the case of carrier results), especially when testing alternative delivery models.",2020,"Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform.",['Post-reproductive adults (N = 462'],[],"['clinical uncertainty', 'affective, evaluative, and clinical uncertainties', 'evaluative uncertainty']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]",1230.0,0.0506405,"Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform.","[{'ForeName': 'Kendall L', 'Initials': 'KL', 'LastName': 'Umstead', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Paul K J', 'Initials': 'PKJ', 'LastName': 'Han', 'Affiliation': 'Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Ilana M', 'Initials': 'IM', 'LastName': 'Miller', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hepler', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Thompson', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Tyra G', 'Initials': 'TG', 'LastName': 'Wolfsberg', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Anh-Dao', 'Initials': 'AD', 'LastName': 'Nguyen', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fredriksen', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Gibney', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Turbitt', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leslie G', 'Initials': 'LG', 'LastName': 'Biesecker', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz111']
1829,31168604,Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial.,"AIMS


The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD).
METHODS AND RESULTS


The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed.
CONCLUSION


Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.",2019,Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05).,"['European heart failure patients with an', '595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system']","['remote patient monitoring (RPM', 'RPM', 'implantable cardioverter-defibrillator', 'RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone', 'implantable cardioverter-defibrillator (ICD', 'remote monitoring']","['device acceptance (FPAS total score', 'Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance', ""patients' health status and ICD acceptance (subscale) scores"", 'health status and ICD acceptance']","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1524057', 'cui_str': 'Compatible with (attribute)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0582523', 'cui_str': 'rpm'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0030695', 'cui_str': 'Patient Monitoring'}, {'cui': 'C0582523', 'cui_str': 'rpm'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",595.0,0.0351965,Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05).,"[{'ForeName': 'Henneke', 'Initials': 'H', 'LastName': 'Versteeg', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Timmermans', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Kimman', 'Affiliation': 'Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Prevot', 'Affiliation': 'Department of Cardiology, Hôpital Privé Clairval, Marseille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauwolf', 'Affiliation': 'Department of Cardiology and Angiology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Marcoen F', 'Initials': 'MF', 'LastName': 'Scholten', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Zitron', 'Affiliation': 'Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mabo', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire, Rennes, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': 'Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Meine', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz140']
1830,32436906,Estimation of salivary calcium level as a screening tool for the osteoporosis in the post-menopausal women: A prospective study.,"Aims and Objectives


The aim and objective of the present study was to explore the use of salivary calcium levels as a diagnostic biochemical marker for osteoporosis in menopausal women and also to find the correlation among oestrogen level, bone density and salivary calcium level.
Materials and Methods


The study included 180 individuals and they were divided into three groups with 60 individuals in each group, comprised of healthy women, pregnant women and post-menopausal women. All the women were asked to collect at least 2 ml of unstimulated whole saliva in the sterile plastic sample containers. The samples were immediately subjected to biochemical estimation of calcium. Similarly, estimation was done for oestrogen level and bone density among all the groups. The results were obtained by one-way analysis of variance (ANOVA) using Statistical Software SPSS version 17. For the correlation among the bone density, salivary calcium level and serum oestrogen levels, Pearson's correlation was used.
Results


The mean salivary calcium level in the healthy women group was found to be 3.0 ± 0.50 μg/ml. Similarly, pregnant women and post-menopausal group, it was found to be 3.20 ± 0.72 and 7.5 ± 0.90 μg/ml, respectively. When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001). Similarly, the difference in mean value for oestrogen level and bone density was highly significant among all the groups (P = 0.001).
Conclusion


Among all the three groups, the salivary calcium levels do exhibit the correlation with bone mineral density. In the post-menopausal group, there was significant increase in salivary calcium level compared to other groups. Similarly, the study showed a negative correlation between salivary calcium and serum oestrogen. This substantiates the point that salivary calcium levels can definitely indicate the possibility of the presence or absence of osteoporosis in post-menopausal women.",2020,"When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001).","['osteoporosis in the post-menopausal women', '180 individuals and they were divided into three groups with 60 individuals in each group, comprised of healthy women, pregnant women and post-menopausal women', 'osteoporosis in menopausal women']",[],"['bone density, salivary calcium level and serum oestrogen levels', 'mean salivary calcium level', 'salivary calcium and serum oestrogen', 'mean value for oestrogen level and bone density', 'oestrogen level, bone density and salivary calcium level', 'oestrogen level and bone density', 'salivary calcium levels', 'salivary calcium level']","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}]",180.0,0.0287424,"When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001).","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Wasti', 'Affiliation': 'Department of Oral Pathology, Government Dental College and Hospital, Raipur, Chhattishagrh, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Wasti', 'Affiliation': 'Department of Periodontology, Government Dental College and Hospital, Raipur, Chhattishagrh, India.'}, {'ForeName': 'Ritunja', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, New Horizon Dental College, Bilaspur, Chhattishagrh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_879_19']
1831,32040960,"Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.","Background


Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT).
Objective


To determine the safety and efficacy of Triplex.
Design


First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933).
Setting


3 U.S. HCT centers.
Participants


102 CMV-seropositive HCT recipients at high risk for CMV reactivation.
Intervention


Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens.
Measurements


The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatment, or end-organ disease), nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD), all evaluated through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination that were probably or definitely attributable to injection.
Results


A total of 102 patients (51 per group) received the first vaccination, and 91 (89.2%) received both vaccinations (46 Triplex and 45 placebo). Reactivation of CMV occurred in 5 Triplex (9.8%) and 10 placebo (19.6%) recipients (hazard ratio, 0.46 [95% CI, 0.16 to 1.4]; P = 0.075). No Triplex recipient died of nonrelapse causes during the first 100 days or had serious AEs, and no grade 3 or 4 AEs related to vaccination were observed within 2 weeks after vaccination. Incidence of severe acute GVHD after injection was similar between groups (hazard ratio, 1.1 [CI, 0.53 to 2.4]; P = 0.23). Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
Limitation


The lower-than-expected incidence of CMV events in the placebo group reduced the power of the trial.
Conclusion


No vaccine-associated safety concerns were identified. Triplex elicited and amplified CMV-specific immune responses, and fewer Triplex-vaccinated patients had CMV viremia.
Primary Funding Source


National Cancer Institute and Helocyte.",2020,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","['≥1250', 'Participants\n\n\n102 CMV-seropositive HCT recipients at high risk for CMV reactivation', 'Transplant Recipients', '102 patients (51 per group) received the first vaccination, and 91 (89.2%) received']","['Poxvirus Vectored Cytomegalovirus Vaccine', 'placebo', 'Triplex or placebo', 'both vaccinations (46 Triplex and 45 placebo']","['Cytomegalovirus Viremia', 'CMV events (CMV DNA level', 'Incidence of severe acute GVHD', 'Levels of long-lasting, pp65-specific T cells with effector memory phenotype', 'nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD', 'CMV events', 'cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation', 'Triplex elicited and amplified CMV-specific immune responses', 'Reactivation of CMV']","[{'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviruses'}, {'cui': 'C0887903', 'cui_str': 'Cytomegalovirus Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",102.0,0.529622,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Aldoss', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Longmate', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Ariza-Heredia', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas (E.J.A.).'}, {'ForeName': 'Wasima N', 'Initials': 'WN', 'LastName': 'Rida', 'Affiliation': 'Biostatistics Consultant, Arlington, Virginia (W.N.R.).'}, {'ForeName': 'Chetan Raj', 'Initials': 'CR', 'LastName': 'Lingaraju', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Kaltcheva', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Dagis', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hardwick', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicolas C', 'Initials': 'NC', 'LastName': 'Issa', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Farol', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Auayporn', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Monzr M', 'Initials': 'MM', 'LastName': 'Al Malki', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Don J', 'Initials': 'DJ', 'LastName': 'Diamond', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2511']
1832,30848783,Reasons for hospitalization and risk of mortality in patients with atrial fibrillation treated with dabigatran or warfarin in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial.,"AIMS


Hospitalizations are common among patients with atrial fibrillation. This article aimed to analyse the causes and consequences of hospitalizations occurring during the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial.
METHODS AND RESULTS


The RE-LY database was used to evaluate predictors of hospitalization using multivariate regression modelling. The relationship between hospitalization and subsequent major adverse cardiac events was evaluated in a time dependent Cox proportional-hazard modelling. Of the 18 113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2 years. First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin. Hospitalization was associated with post-discharge death [absolute event rate 9.1% vs. 2.2%; adjusted hazard ratio (HR) 3.6, 95% confidence interval (CI) 3.2-4.0, P < 0.0001], vascular death (adjusted HR 2.9, 95% CI 2.5-3.3, P < 0.0001), and sudden cardiac death (adjusted HR 2.3; 95% CI 1.8-2.9, P < 0.0001). Cardiovascular hospitalization was also associated with an increased risk of post-discharge death (adjusted HR 2.8, 95% CI 2.5-3.2, P < 0.0001), vascular death (adjusted HR 2.8, 95% CI 2.4-3.2, P < 0.0001), and sudden cardiac death (adjusted HR 2.1, 95% CI 1.6-2.7, P < 0.0001) compared with patients not hospitalized for any cardiovascular reason.
CONCLUSION


Hospitalizations are associated an increased risk of with death and cardiovascular death in patients with atrial fibrillation.",2019,"First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin.","['Of the 18\u2009113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2\u2009years', 'patients with atrial fibrillation', 'patients with atrial fibrillation treated with']","['dabigatran or warfarin', 'warfarin']","['vascular death', 'First hospitalization rates', 'risk of post-discharge death', 'hospitalization and subsequent major adverse cardiac events', 'Cardiovascular hospitalization', 'risk of with death and cardiovascular death', 'sudden cardiac death', 'hospitalization and risk of mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",18113.0,0.33727,"First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin.","[{'ForeName': 'Aiman', 'Initials': 'A', 'LastName': 'Alak', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, J.W. Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fräßdorf', 'Affiliation': 'Boehringer Ingelheim GmbH & Co, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ezekowitz', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Faculty of Medicine, Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz021']
1833,32436899,Treatment of miller type I and II gingival recession defects using three-dimensional porcine collagen matrix with coronally advanced flap: A randomized clinical split-mouth trial (a 1-year follow-up).,"Introduction


The main goal of periodontal plastic surgery is obtaining complete root coverage (CRC) and an optimal appearance.
Aim


The aim of this study was to evaluate the effectiveness of a three-dimensional porcine collagen matrix (PCM) with coronally advanced flap (CAF) in treating of Miller type I and II gingival recession (GR).
Materials and Methods


Twenty patients were enrolled in this study, presenting 40 Miller type I and II GR. Patients were randomized into test group (PCM + CAF) and control group [connective tissue graft (CTG + CAF)]. Clinical parameters such as recession depth (RD), probing depth, clinical attachment level (CAL), and width of keratinized gingiva (WKG) were evaluated at baseline and 12 months later. Root coverage percentage (RC%) and CRC were assessed at 12 months post surgically. Statistical analysis was performed using independent t-test for intergroup comparison. Statistical significance was set at 0.05.
Results


The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF. CRC was higher in CTG + CAF with 80%. CAL gain was 2.05 and 2.07 mm in the test and control sites, respectively. The gain of WKG was 1.35 and 1.30 mm in the test and control sites, respectively. Patient esthetic satisfaction at 12 months post surgically in both groups was equivalent.
Conclusion


Within the limits of this study, using of PCM + CAF in treating GR is a successful and effective treatment option and could serve as an alternative to CTGs.",2020,"The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF.","['Twenty patients were enrolled in this study, presenting 40 Miller type I and II GR']","['PCM + CAF', 'test group (PCM + CAF) and control group [connective tissue graft (CTG + CAF', 'three-dimensional porcine collagen matrix (PCM) with coronally advanced flap (CAF', 'miller type I and II gingival recession defects using three-dimensional porcine collagen matrix with coronally advanced flap']","['mean RC', 'CAL gain', 'Patient esthetic satisfaction', 'mean RD', 'CRC', 'Root coverage percentage (RC%) and CRC', 'recession depth (RD), probing depth, clinical attachment level (CAL), and width of keratinized gingiva (WKG', 'gain of WKG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}]",20.0,0.0540649,"The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF.","[{'ForeName': 'Haydar', 'Initials': 'H', 'LastName': 'Barakat', 'Affiliation': 'Department of Periodontology, Dental Faculty, Damascus University, Damascus, Syria.'}, {'ForeName': 'Suleiman', 'Initials': 'S', 'LastName': 'Dayoub', 'Affiliation': 'Department of Periodontology, Dental Faculty, Damascus University, Damascus, Syria.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_897_18']
1834,32436905,Comparative evaluation of occlusal pits and fissures morphology modification techniques before application of sealants: An  In vitro  study.,"Background


Pits and Fissures are recognized as being highly susceptible to caries. Pit and fissure sealants are one of the best methods of preventing caries as it occludes the fissures and pits from the accumulation of plaque and cariogenic microflora. There are different methods of cleaning and preparing occlusal pits and fissures for preventing caries which helps in alleviating oral health status of paediatric population.
Aim


The aim of the present study was to evaluate and compare the microleakage of pit and fissure sealants after using five different preparation techniques, namely: A) Conventional technique using pumice prophylaxis, B) enameloplasty with round carbide bur, C) enameloplasty with fissurotomy bur, D) air polisher, and E) air abrasion.
Materials and Methods


The study was conducted on 50 caries-free premolars extracted for orthodontic purpose. These teeth were randomly assigned to five groups, 10 teeth in each for receiving fissure sealant after different surface preparation; thermocycling and sectioning of samples were performed and microleakage was assessed under a stereomicroscope after methylene blue dye immersion.
Results


The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
Conclusion


To improve the marginal adaptation of the sealants, minimally invasive methods are the most favoured methods of occlusal preparation. This study promises to show positive results for fissure sealants which are likely to play an important role in caries prevention and techniques that are intended to protect caries susceptible surfaces.",2020,"The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
",['50 caries-free premolars extracted for orthodontic purpose'],"['Conventional technique using pumice prophylaxis, B) enameloplasty with round carbide bur, C) enameloplasty with fissurotomy bur, D) air polisher, and E) air abrasion', 'fissure sealant after different surface preparation; thermocycling and sectioning of samples were performed and microleakage was assessed under a stereomicroscope after methylene blue dye immersion']",['microleakage of pit and fissure sealants'],"[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0072604', 'cui_str': 'pumice'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0031992', 'cui_str': 'Pit Fissure Sealants'}]",50.0,0.0450896,"The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Dentistry, Nalanda Medical College and Hospital, Patna, Bihar, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Vishwas', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil University (DPU)), Pune, Maharashtra, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Juyal', 'Affiliation': 'MDS, (Paediatric and Preventive Dentistry), Consultant, Cloud 32 Dental Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department of Public Health Dentistry, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Priyadershini', 'Initials': 'P', 'LastName': 'Rangari', 'Affiliation': 'Department of Dentistry, Sri Shankaracharya Institute of Medical Sciences, Bhilai, Durg, Chhattisgarh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_956_19']
1835,30721985,Effect of Reactive Balance Training Involving Repeated Slips and Trips on Balance Recovery Among Older Adults: A Blinded Randomized Controlled Trial.,"BACKGROUND


This study examined whether reactive balance training (exposures to slips and trips) could improve balance recovery and reduce perturbation-induced falls among older adults.
METHODS


Forty-four community-dwelling older adults participated in a parallel, blinded randomized controlled trial conducted in a research institute in Sydney, Australia in 2017-2018 (ACTRN12617000564358). The intervention group (n = 22) underwent three 40 minutes sessions (total 120 minutes) that exposed them to (1) 20 trips, (2) 20 slips, and (3) 10 trips and 10 slips in mixed order, over 2 days. The control group (n = 22) received one 40 minutes session of sham training. The primary outcome was falls (>30% body weight in harness) when exposed to trips and slips at post-assessment.
RESULTS


At post-assessment, a total of 51 falls (23 and 27 falls from induced slips and trips, respectively) were recorded in the laboratory. Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR] = 0.40, 95% confidence interval [CI] = 0.22-0.76), slip falls (RR = 0.33, 95% CI = 0.12-0.90) and trip falls (RR = 0.49, 95% CI = 0.21-1.12). Eight participants reported adverse events (5 in the intervention group and 3 in the control group) which were related mainly to discomfort caused by a suboptimal harness used in the initial stages of the trial.
CONCLUSIONS


The reactive balance training reduced perturbation-induced falls by 60% indicating improved balance recovery from trips and slips. A comfortable safety harness system is essential to prevent discomfort. Reactive balance training may complement traditional exercise programs in fall prevention interventions.",2019,"Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR]=0.40, 95% confidence interval [CI]=0.22-0.76), slip falls (RR=0.33, 95% CI=0.12-0.90) and trip falls (RR=0.49, 95% CI=0.21-1.12).","['Methods\n\n\nForty-four community-dwelling older adults', 'older adults']","['reactive balance training (exposures to slips and trips', 'reactive balance training', 'Reactive balance training', 'one 40-min session of sham training']","['trip falls', 'falls (>30% body weight in harness', 'adverse events', 'slip falls', 'total falls']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0221188', 'cui_str': 'Tripping (event)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0221188', 'cui_str': 'Tripping (event)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3873748', 'cui_str': 'Harness (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.123032,"Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR]=0.40, 95% confidence interval [CI]=0.22-0.76), slip falls (RR=0.33, 95% CI=0.12-0.90) and trip falls (RR=0.49, 95% CI=0.21-1.12).","[{'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daina L', 'Initials': 'DL', 'LastName': 'Sturnieks', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Brodie', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lionne', 'Initials': 'L', 'LastName': 'Duran', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz021']
1836,32436902,Efficacy of omega 3 fatty acid as an adjunct in the management of chronic periodontitis: A randomized controlled trial.,"Background


: Periodontitis is conventionally treated with both surgical and nonsurgical methods. Various adjuncts have been used previously with compromised efficacy. Recently omega-3(ώ-3) polyunsaturated fatty acids (PUFA) including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) were shown to have therapeutic anti-inflammatory and protective actions in inflammatory diseases including periodontitis. The purpose of the present study was to evaluate and compare the clinical efficacy of ώ-3 fatty acids as an adjunct to scaling and root planing in the treatment of periodontitis.
Methods


110 Patients were selected for the study out of which 20 were excluded (12 not meeting the inclusion criteria and 8 refused to participate). 90 patients (48 in test and 42 in the control group) after randomisation through a coin toss method were enrolled in a single-blind randomised controlled trial conducted in the Periodontics department of a dental college. Full mouth subgingival scaling and root planing and ώ-3 fatty acid 500 mg (EPA/DHA 180/120 mg), BD daily for 1 month was given to the test group and subgingival scaling and root planing only was given to the control group. Clinical parameters like probing pocket depth, clinical attachment level, plaque index and gingival index were recorded at baseline, 1 and 3 months and were compared.
Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group. There was a significant gain in clinical attachment level (t = 63.29, P = 0.000) and (t = 31.03, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group. The gingival index shows an appreciable reduction in both groups, and in test group, it is statistically significant at 3 months (t = 2.15, P = 0.03). There was no statistical significant reduction in plaque index at 3 months (t = 0, P = 0.997).
Conclusion


The present study showed that adjunctive use of ώ-3 fatty acids proved to be beneficial over scaling and root planing alone in the treatment of chronic moderate periodontitis. The beneficial effects were in terms of significant improvements in clinical parameters, probing pocket depth, and clinical attachment level and gingival index. Dietary modulation is now emerging as an adjunct to periodontal therapy. Hence, omega-3 fatty acid may be used routinely in the management of chronic periodontitis.",2020,"Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group.","['90 patients (48 in test and 42 in the control group) after randomisation through a coin toss method were enrolled in a single-blind randomised controlled trial conducted in the Periodontics department of a dental college', 'chronic periodontitis', '110 Patients were selected for the study out of which 20 were excluded (12 not meeting the inclusion criteria and 8 refused to participate', 'chronic moderate periodontitis']","['ώ-3 fatty acids', 'omega 3 fatty acid', 'fatty acid 500 mg (EPA/DHA', 'omega-3(ώ-3) polyunsaturated fatty acids (PUFA) including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'omega-3 fatty acid']","['clinical attachment level', 'Clinical parameters like probing pocket depth, clinical attachment level, plaque index and gingival index', 'probing pocket depth', 'clinical parameters, probing pocket depth, and clinical attachment level and gingival index', 'gingival index', 'plaque index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",110.0,0.0651708,"Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group.","[{'ForeName': 'Shirish K', 'Initials': 'SK', 'LastName': 'Kujur', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Goswami', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Anand M', 'Initials': 'AM', 'LastName': 'Nikunj', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Gangesh', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Bandhe', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Himanta', 'Initials': 'H', 'LastName': 'Ghritlahre', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_647_18']
1837,32436911,Microleakage patterns of glass ionomer cement at cement-band and cement-enamel interfaces in primary teeth.,"Context


In-vitro studies of microleakage are an initial screening method to assess the maximum theoretical loss of sealing ability in-vivo.
Aims


Our objective was to determine and compare microleakage patterns of conventional glass ionomer cement (GIC) and resin-modified GIC (RMGIC) for band cementation.
Methods


Forty caries-free second primary molars were randomly divided into two groups of 20 teeth each. Preformed molar bands in the two groups were cemented to enamel with one of two types of cement: Conventional GIC (Fuji I, GC Corporation; Tokyo, Japan) and RMGIC (Fuji Plus, GC Corporation; Tokyo, Japan). A dye penetration method was used for microleakage evaluation. Microleakage was determined by a stereomicroscope for the cement-band and cement-enamel interfaces.
Statistical Analysis Used


Statistical analysis was performed with Kruskal-Wallis and Mann-Whitney U tests.
Results


The mean microleakage value for conventional GIC (Fuji I) at cement-band and cement-enamel interfaces was 2.41 mm and 2.15 mm, respectively. The mean microleakage value for RMGIC (Fuji Plus) at cement-band and cement-enamel interfaces was 0.44 mm and 0.46 mm, respectively. Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces. P < 0.001 and it was statistically highly significant.
Conclusions


Bands cemented with RMGIC had significantly less microleakage between the cement-band and cement-enamel interfaces than conventional GIC.",2020,"Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces.","['Microleakage patterns of glass ionomer cement at cement-band and cement-enamel interfaces in primary teeth', 'Methods\n\n\nForty caries-free second primary molars']","['conventional glass ionomer cement (GIC) and resin-modified GIC (RMGIC', 'conventional GIC, RMGIC']","['Microleakage', 'mean microleakage value', 'microleakage', 'mean microleakage value for RMGIC']","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",40.0,0.0352895,"Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Venkatesan', 'Affiliation': 'Department of Restorative Dentistry, Al Farabi Dental College, Jeddah, Saudi Arabia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Senthil', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Trophimus', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'C U', 'Initials': 'CU', 'LastName': 'Arthilakshmi', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Philomine', 'Initials': 'P', 'LastName': 'Princy', 'Affiliation': 'Department of Restorative Dentistry, Al Farabi Dental College, Jeddah, Saudi Arabia.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_850_19']
1838,31502032,Holmium laser enucleation of the prostate versus thulium laser enucleation of the prostate for the treatment of large-volume prostates > 80 ml: 18-month follow-up results.,"PURPOSE


To compare the perioperative and functional outcomes of holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) for the treatment of large-volume benign prostatic hyperplasia (BPH) (> 80 ml).
METHODS


A total of 116 consecutive patients with BPH were randomized to be treated surgically with either HoLEP (n = 58) or ThuLEP (n = 58), following the classical three-lobe enucleation technique. Follow-up was assessed at 1, 3, 6, 12 and 18 months after surgery.
RESULTS


At 18 months, the lower urinary tract symptom index was improved significantly in both groups compared with the baseline values. The operative time (78.4 ± 8.0 vs. 71.4 ± 6.4 min) and enucleation time (61.2 ± 5.4 vs. 56.4 ± 8.4 min) were significantly shorter for ThuLEP compared to HoLEP (both p < 0.001). There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05). The HoLEP and ThuLEP groups had equivalent International Prostate Symptom Scores (3 [3-3] vs. 3 [3-3], p = 0.776), quality of life (1 [1-2] vs. 2 [1-2], p = 0.809), Qmax (25.3 ± 4.8 ml/s vs. 24.7 ± 4.4 ml/s, p = 0.470), postvoid residual urine (PVR) (6.1 [2.6-20.8] vs. 7.7 [3.1-22.8] ml, p = 0.449) and PSA (0.84 ± 0.32 vs. 0.90 ± 0.34 ml, p = 0.309) at 18 months postoperatively.
CONCLUSION


Both HoLEP and ThuLEP relieve lower urinary tract symptoms in a comparable way with high efficacy and safety. ThuLEP was statistically superior to HoLEP in operation time and enucleation time, although the differences were clinically negligible.",2020,"There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05).","['large-volume prostates\u2009', 'large-volume benign prostatic hyperplasia (BPH) (>\u200980\xa0ml', '116 consecutive patients with BPH']","['Holmium laser enucleation of the prostate versus thulium laser enucleation', 'HoLEP', 'classical three-lobe enucleation technique', 'holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP', 'HoLEP and ThuLEP', 'ThuLEP']","['quality of life', 'postvoid residual urine (PVR', 'operative time', 'equivalent International Prostate Symptom Scores', 'enucleation time', 'urinary tract symptoms', 'lower urinary tract symptom index', 'operation time and enucleation time', 'morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1293635', 'cui_str': 'Laser enucleation of the prostate'}]","[{'cui': 'C0034380'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",116.0,0.0255013,"There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05).","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Ou', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Ruizhe', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Lingxiao', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, China.'}, {'ForeName': 'Shusuan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medical, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China. wanglong@csu.edu.cn.'}]",World journal of urology,['10.1007/s00345-019-02945-x']
1839,32433572,Effect of antiseptic gels in the microbiologic colonization of the suture threads after oral surgery.,"Three different bioadhesive gels were evaluated in a double-blind randomized clinical trial in which microbial growth in the suture thread was assessed following post-surgical application of the aforementioned gels. Also assessed in this trial were, the intensity of post-surgical pain as well as the degree of healing of the patients' surgical wounds. A total of 21 patients (with 42 wisdom teeth) participated in this trial. Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel were evaluated, with a neutral water-based gel serving as the control agent. The aerobic and facultative anaerobic bacterial recovery on blood agar was lower in the placebo group than in the experimental groups. The most significant difference (p = 0.04) was observed in the chlorhexidine-chitosan group. in which the growth of Blood Agar and Mitis Salivarius Agar was significantly higher than in the placebo group. The intensity of post-surgical pain was very similar among all the groups. Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01). Through our microbiological analyses, we were able to conclude that none of the bioadhesive gels tested resulted in beneficial reductions in the bacterial/fungal populations. However, the healing rates of patients who were treated with chlorhexidine-chitosan were better than those of the patients who used either the placebo gel or the hyaluronic acid gel.",2020,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","['21 patients (with 42 wisdom teeth', 'microbiologic colonization of the suture threads after oral surgery']","['chlorhexidine-chitosan gel', 'placebo gel or the hyaluronic acid gel', 'hyaluronic acid gel', 'chlorhexidine', 'Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel', 'chlorhexidine-chitosan', 'antiseptic gels', 'placebo']","['blood agar', 'intensity of post-surgical pain', 'Blood Agar and Mitis Salivarius Agar', 'healing rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}]","[{'cui': 'C3266603', 'cui_str': 'Blood agar'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001771', 'cui_str': 'Agar'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",21.0,0.0631417,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rodríguez Zorrilla', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain. samuel.rodriguez.zorrilla@outlook.com.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Blanco Carrión', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'García García', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Marichalar Mendía', 'Affiliation': 'Department of Stomatology II. School of Medicine and Dentistry, Leioa, Bizkaia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Seoane Prado', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Pérez Estévez', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pérez-Sayáns', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}]",Scientific reports,['10.1038/s41598-020-65007-y']
1840,31499457,Age differences in electrocortical reactivity to fearful faces following aversive conditioning in youth.,"Although biases in the processing of affectively salient stimuli are thought to increase risk for psychopathology across the lifespan, questions remain regarding how these biases develop. The current study tested an aversive conditioning model for the development of children's sensitivity in detecting fearful faces at varying levels of emotional intensity and their facilitated attention to fearful faces assessed via the late positive potential (LPP) event-related potential component. Participants (N = 144, ages 7-11 years) were randomly assigned to one of three conditions: an active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition. Children completed a separate task in which they viewed happy, sad, and fearful child faces at varying levels of emotional intensity while electroencephalography (EEG) was recorded. Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age. Among younger children, those in the active conditioning group exhibited smaller LPP amplitudes to high-intensity fearful faces than children in the control groups. However, among older youth, those in the active conditioning group exhibited larger LPP amplitudes to high-intensity fearful faces than children in the control groups. These findings provide insight into how attentional biases may develop in children and how period of development may influence these patterns.",2019,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","['youth', 'younger children', 'Participants (N\u202f=\u202f144, ages 7-11\u202fyears']","['active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition']","['smaller LPP amplitudes', 'LPP amplitudes', 'LPP magnitude']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",,0.0533471,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Burkhouse', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60608, USA. Electronic address: kburkho@uic.edu.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL 33701, USA.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}, {'ForeName': 'Brandon E', 'Initials': 'BE', 'LastName': 'Gibb', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104676']
1841,31274152,Electrically vs. imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial.,"AIMS


To test in a double-blinded, randomized trial whether the combination of electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd) optimization results in superior increase in LV ejection fraction (LVEF) in cardiac resynchronization therapy (CRT) recipients.
METHODS AND RESULTS


Stratified according to presence of ischaemic heart disease, 122 patients were randomized 1:1 to LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group). Follow-up was 6 months. Primary endpoint was absolute increase in LVEF. Additional outcome measures were changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications. Analysis was intention-to-treat. A larger increase in LVEF was observed in the intervention group (11 ± 10 vs. 7 ± 11%; 95% confidence interval 0.4-7.9%, P = 0.03); when adjusting for pre-specified baseline covariates this difference did not maintain statistical significance (P = 0.09). Clinical response, LV reverse remodelling, and complication rates did not differ between treatment groups.
CONCLUSION


Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response. Larger long-term studies are warranted to investigate the effect of an electrically guided CRT strategy.",2019,"Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response.","['cardiac resynchronization therapy (CRT) recipients', '122 patients']","['cardiac resynchronization therapy', 'Electrically guided CRT implantation', 'Electrically vs. imaging-guided left ventricular lead placement', 'electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd', 'LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group']","['LV ejection fraction (LVEF', 'Clinical response, LV reverse remodelling, and complication rates', 'absolute increase in LVEF', 'LVEF', 'changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications']","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0456944', 'cui_str': 'Coronary Sinus'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2317140', 'cui_str': 'CT venography'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0439691', 'cui_str': 'Speckled (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",122.0,0.34946,"Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Stephansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sommer', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Mads Brix', 'Initials': 'MB', 'LastName': 'Kronborg', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Jesper Møller', 'Initials': 'JM', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Bjarne Linde', 'Initials': 'BL', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerdes', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Henrik Kjærulf', 'Initials': 'HK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Daniel Benjamin', 'Initials': 'DB', 'LastName': 'Fyenbo', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bouchelouche', 'Affiliation': 'Department of Nuclear Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}, {'ForeName': 'Jens Cosedis', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz184']
1842,32437025,Pharmacokinetics and Safety of Ranirestat in Patients With Hepatic Impairment.,"Ranirestat is an aldose reductase inhibitor hypothesized to improve diabetic neuropathy. An open-label, single-dose, parallel-group study was conducted to compare pharmacokinetic (PK) characteristics of an oral dose of ranirestat across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat is expected to be used by patients with diabetes mellitus, possibly including those with hepatic impairment. To evaluate the necessity for dose adjustment, PK profiles and tolerability were studied at the dose of 40 mg, the expected optimal clinical dose in patients with diabetic neuropathy and normal hepatic function. In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study. Serial PK sampling was conducted up to 504 hours, and PK parameters were calculated and compared between healthy subjects and patients with mild or moderate hepatic impairment. The geometric mean ratios of peak concentration and area under the concentration-time curve in patients with mild hepatic impairment (90%CI) were 86.7% (55.3% to 135.9%) and 84.7% (68.5% to 104.8%), respectively. The values in patients with moderate hepatic impairment were 81.3% (48.8% to 135.5%) and 91.7% (72.1% to 116.7%), respectively. These results demonstrated that plasma ranirestat exposure and the plasma protein binding of the drug were not substantially altered by normal, mild, or moderate hepatic impairment (protein binding 99.22%, 99.29%, and 99.00%, respectively). All adverse events were mild in severity. Based on these findings, no dose adjustment will be required for ranirestat in patients with mild or moderate hepatic impairment.",2020,All adverse events were mild in severity.,"['In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study', 'healthy subjects and patients with mild or moderate hepatic impairment', 'patients with mild or moderate hepatic impairment', 'patients with diabetes mellitus, possibly including those with hepatic impairment', 'across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat', 'patients with diabetic neuropathy and normal hepatic function', 'Patients With Hepatic Impairment']",['ranirestat'],"['moderate hepatic impairment', 'plasma ranirestat exposure and the plasma protein binding', 'geometric mean ratios of peak concentration and area under the concentration-time curve']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C3266874', 'cui_str': 'ranirestat'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",20.0,0.0316012,All adverse events were mild in severity.,"[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Itou', 'Affiliation': 'JSDF Hanshin Hospital, Hyogo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Pharmacology and Toxicology, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Gastroenterology, Showa University Fujigaoka Hospital, Kanagawa, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Takagaki', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ishii', 'Affiliation': 'Group I, Oncology Clinical Development Unit, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1636']
1843,31425040,The Effects of Technology-Assisted Ankle Rehabilitation on Balance Control in Stroke Survivors.,"Many stroke survivors have impaired balance control. This study assesses the effects of ankle stretching exercising with our recently developed Motorized Ankle Stretcher (MAS) technology compared to exercising with a stretching board, on stroke survivors' balance control. Sixteen stroke survivors were randomly assigned to a control group (CG) and an intervention group (IG). The CG and IG performed ankle stretching exercises with the stretching board and MAS, respectively, two days per week for four consecutive weeks. Balance performance was assessed by a Sensory Organization Test (SOT) at the beginning of week 1 (pre-assessment), at the end of week 4 (post-assessment), and 1 month after week 4 (retention-assessment). Balance performance was quantified by a root-mean-square (RMS), range, and area of body's center of pressure (COP) data obtained by the SOT. The IG significantly improved COP RMS and COP range in the anterior-posterior direction at the post- and retention-assessments compared to the pre-assessment. The IG also significantly improved COP area at the retention-assessment compared to the pre-assessment. The improvements were not observed in the CG. The findings of this study have clinical implications since the MAS potentially could be used in both domestic and clinical settings.",2019,The IG significantly improved COP RMS and COP range in the anterior-posterior direction at the post-and retention-assessments compared to the pre-assessment.,"['Sixteen stroke survivors', 'stroke survivors']","['technology-assisted ankle rehabilitation', 'control group (CG', 'Motorized Ankle Stretcher (MAS) technology', 'ankle stretching exercising']","['Balance performance', 'COP RMS and COP range', 'Sensory Organization Test (SOT', ""root-mean-square (RMS), range, and area of body's center of pressure (COP) data"", 'COP area']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150789', 'cui_str': 'Patient Holding Stretchers'}, {'cui': 'C0556830', 'cui_str': 'Ankle stretching (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test (assessment scale)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0188612,The IG significantly improved COP RMS and COP range in the anterior-posterior direction at the post-and retention-assessments compared to the pre-assessment.,"[{'ForeName': 'Dongyual', 'Initials': 'D', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Dae-Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kap-Ho', 'Initials': 'KH', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Beom-Chan', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2934930']
1844,31881599,"Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction.","BACKGROUND


XPAND II was a prospective, multicenter, single-arm, open-label, continued-access study designed to confirm the results from the XPAND study, a multicenter, prospective, randomized study for breast reconstruction. The AeroForm device received clearance from the U.S. Food and Drug Administration in December 2016 based on the results of the pivotal XPAND trial, which compared the AeroForm to saline expanders.
METHODS


Fifty women were treated in the XPAND II study and implanted with the AeroForm device (86 devices). The study endpoint was successful completion of the second-stage surgery, and secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction. Following implantation, women were administered 10-cc doses of carbon dioxide at home up to three times daily. When adequate expansion was achieved, the expanders were exchanged for standard breast implants.
RESULTS


The primary endpoint (successful exchange to standard breast implant, precluding non-device-related failures) is 100 percent. All-cause interim success is 95 percent, with three subjects (four breasts) failing primary exchange because of non-device-related reasons. Median time to complete expansion was 21 days (range, 5 to 117 days). Median time to complete the reconstruction was 112 days (range, 55 to 329 days). Ninety-six percent of the subjects were very or moderately satisfied with the AeroForm expansion process.
CONCLUSIONS


Results of the XPAND II continued access study confirm and improve on previous results from the randomized trial (XPAND). These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, IV.",2020,"These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
","['Ninety-six percent of the subjects were very or moderately satisfied with the AeroForm expansion process', 'Fifty women were treated in the XPAND II study and implanted with the AeroForm device (86 devices']",['carbon dioxide'],"['Median time to complete expansion', 'Median time', 'successful completion of the second-stage surgery, and secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction', 'primary endpoint (successful exchange to standard breast implant, precluding non-device-related failures']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",50.0,0.0671393,"These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Ascherman', 'Affiliation': ""New York, N.Y.; Campbell and Corte Madera, Calif.; Charlotte, N.C.; Worcester and Boston, Mass.; and Fort Lauderdale, Fla. From the Division of Plastic Surgery, Columbia University College of Physicians and Surgeons, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetx: Aesthetic and Reconstructive Plastic Surgery; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital, Brigham and Women's Faulkner Hospital, Harvard Medical School; and eSSe Plastic Surgery.""}, {'ForeName': 'Kamakshi', 'Initials': 'K', 'LastName': 'Zeidler', 'Affiliation': ''}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Appel', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Castle', 'Affiliation': ''}, {'ForeName': 'Yoon', 'Initials': 'Y', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Colwell', 'Affiliation': ''}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Mohebali', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sudarsky', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006395']
1845,31188437,"Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes.","CONTEXT


Patients with type 1 diabetes (T1D) have lower microbiota diversity and distinct gut microbial profiles that have been linked to changes in intestinal permeability. Prebiotics are nondigestible carbohydrates that alter gut microbiota and could potentially improve glycemic control and reduce intestinal permeability and thereby insulin sensitivity.
OBJECTIVE


To determine the effect of prebiotics on glycemic control, gut microbiota, and intestinal permeability in children with T1D.
DESIGN


A randomized, placebo-controlled trial in children 8 to 17 years of age with T1D using placebo or prebiotic oligofructose-enriched inulin for 12 weeks. Baseline, 3-month, and 6-month assessments included HbA1c, C-peptide, gut microbiota, intestinal permeability, frequency of diabetic ketoacidosis (DKA), and severe hypoglycemia.
RESULTS


Forty-three subjects were randomized and 38 completed the study. The groups were similar at baseline: prebiotic (N = 17), age 12.5 years (SD of 2.8), HbA1c 8.02% (SD of 0.82); placebo (N = 21), age 12.0 years (SD of 2.6), HbA1c 8.08% (SD of 0.91). No significant differences were found in the frequency of DKA or severe hypoglycemia. At 3-months, C-peptide was significantly higher (P = 0.029) in the group who received prebiotics, which was accompanied by a modest improvement in intestinal permeability (P = 0.076). There was a significant increase in the relative abundance of Bifidobacterium within the prebiotic group at 3 months that was no longer present after the 3-month washout. The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinivorans, Terrisporobacter, and Faecalitalea compared with the prebiotic group at 3 months.
CONCLUSION


Prebiotics are a potentially novel, inexpensive, low-risk treatment addition for T1D that may improve glycemic control. Further larger-scale trials are needed.",2019,"The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea compared to the prebiotic group at 3 months.
","['Patients with type 1 diabetes (T1D', 'children with type 1 diabetes', 'children 8-17 years with T1D using placebo or prebiotic oligofructose-enriched inulin for 12 weeks', '43 subjects were randomized and 38 completed the study', 'children with T1D']","['prebiotic', 'placebo']","['A1C, C-peptide, gut microbiota, IP, frequency of diabetic ketoacidosis (DKA), and severe hypoglycemia', 'frequency of DKA or severe hypoglycemia', 'relative abundance of Bifidobacterium', 'microbiota, intestinal permeability and glycemic control', 'relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C3986447', 'cui_str': 'Genus Faecalitalea (organism)'}]",43.0,0.236565,"The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea compared to the prebiotic group at 3 months.
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alissa C', 'Initials': 'AC', 'LastName': 'Nicolucci', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Virtanen', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schick', 'Affiliation': 'International Microbiome Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00481']
1846,31881621,Evaluation of Hydrocodone/Acetaminophen for Pediatric Laceration Repair: A Randomized Trial.,"BACKGROUND


Laceration repair is a common procedure, and causes pain and distress in children. The purpose of this study was to measure the effect of hydrocodone/acetaminophen elixir in reducing both pain and anxiety in children undergoing sutured laceration repair in the emergency department.
METHODS


The authors conducted a randomized, double-blinded, placebo-controlled trial in children aged 2 to 17 years, stratified by age younger than 8 years, with topical lidocaine-treated lacerations requiring sutured repair in the emergency department. The primary outcome was pain score at 5 minutes of laceration repair. Secondary outcomes included progression to procedural sedation and anxiety scores in older children.
RESULTS


Eighty-five children were randomized, 43 to the hydrocodone/acetaminophen group and 42 to the placebo group. Median 5-minute pain scores in children aged 2 to 7 years were significantly lower in the medication group (5.0; interquartile range, 4.0 to 6.50) compared with the placebo group (7.0; interquartile range, 5.25 to 10.0; p = 0.01). Three patients (12 percent) in the placebo group proceeded to procedural sedation. For children aged 8 to 17 years, there was no significant difference in pain scores between the treatment (0.5; interquartile range, 0.0 to 0.1; p = 0.81) and placebo groups (0.1; interquartile range, 0.01 to 0.4) or in anxiety scores using the State-Trait Anxiety Inventory for Children.
CONCLUSION


Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
","['children', 'Eighty-five children', 'children undergoing sutured laceration repair in the emergency department', 'treated lacerations requiring sutured repair in the emergency department', 'Pediatric Laceration Repair', 'children younger than 8 years undergoing', 'children aged 2 to 17 years, stratified by age younger than 8 years, with']","['Hydrocodone/Acetaminophen', 'hydrocodone/acetaminophen', 'hydrocodone/acetaminophen elixir', 'placebo', 'topical lidocaine']","['progression to procedural sedation and anxiety scores in older children', 'pain scores', 'procedural sedation', 'Median 5-minute pain scores', 'anxiety scores', 'pain score at 5 minutes of laceration repair', 'pain', 'pain and anxiety', 'pain or anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C3472337', 'cui_str': 'Sutured laceration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}]","[{'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0678430', 'cui_str': 'Elixir (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",85.0,0.708415,"Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
","[{'ForeName': 'Corrie E', 'Initials': 'CE', 'LastName': 'Chumpitazi', 'Affiliation': 'Houston, Texas From the Department of Pediatrics, Section of Emergency Medicine, Baylor College of Medicine.'}, {'ForeName': 'A Chantal', 'Initials': 'AC', 'LastName': 'Caviness', 'Affiliation': ''}, {'ForeName': 'Glenda H', 'Initials': 'GH', 'LastName': 'Grawe', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Camp', 'Affiliation': ''}, {'ForeName': 'Manish I', 'Initials': 'MI', 'LastName': 'Shah', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006383']
1847,31881623,Population-Based Health Utility Assessment of Migraine Headache Symptoms before and after Surgical Intervention.,"BACKGROUND


Approximately 30 million Americans suffer from migraine headaches. The primary goals of this study are to (1) use Migraine-Specific Symptoms and Disability criteria and Migraine Headache Index to describe the symptomatic improvement following decompressive surgery for refractory migraines, and (2) use the average Migraine Headache Index preoperatively and postoperatively for health utility assessment from a healthy patient's perspective.
METHODS


The Migraine-Specific Symptoms and Disability criteria and the Migraine Headache Index were used to characterize migraine symptoms in the authors' patient population before and after decompressive surgery. Healthy individuals were randomized to a scenario in which they assumed either the preoperative or postoperative average patient symptom profile described by the authors' migraine patients. Health utility assessments were used to quantify the evaluation of health states the authors' patients experienced before and after surgical migraine therapy.
RESULTS


Twenty-five patients underwent surgery for migraine headaches. The Migraine-Specific Symptoms and Disability questionnaire showed a significant decrease in both frequency of headaches per month (p < 0.0001) and overall pain score (p = 0.007). The Migraine Headache Index demonstrated a statistically significant improvement (p = 0.03). Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
CONCLUSION


This is the first study to use health utility assessments to attest the efficacy of decompressive therapy by demonstrating the population perspective, which perceived a significant improvement in quality of life following the surgical treatment of migraines in the authors' patients.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, IV.",2020,"Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
","['Approximately 30 million Americans suffer from migraine headaches', 'Twenty-five patients underwent surgery for migraine headaches', 'Healthy individuals']",[],"['Migraine-Specific Symptoms and Disability criteria and Migraine Headache Index', 'frequency of headaches', 'overall pain score', 'utility scores', 'quality of life', 'average Migraine Headache Index preoperatively and postoperatively for health utility assessment', 'Migraine Headache Symptoms', 'Migraine-Specific Symptoms and Disability questionnaire', 'Migraine Headache Index']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0207698,"Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
","[{'ForeName': 'Radbeh', 'Initials': 'R', 'LastName': 'Torabi', 'Affiliation': 'New Orleans, La.; Boston, Mass.; and Phoenix, Ariz. From the Department of Surgery, Section of Plastic and Reconstructive Surgery, School of Medicine, Louisiana State University Health Sciences Center; Tulane School of Medicine; the Department of Surgery, Section of Plastic and Reconstructive Surgery, Massachusetts General Hospital; and Elite Plastic Surgery.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Bourn', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Veith', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wisecarver', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Briley', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bartow', 'Affiliation': ''}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Austen', 'Affiliation': ''}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tessler', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006380']
1848,31892724,Acquisition of chopstick-operation skills with the non-dominant hand and concomitant changes in brain activity.,"Despite their common use as eating utensils in East Asia, chopsticks require complex fine motor-skills for adequate operation and are thus most frequently used with the dominant hand; however, the effect of training time on the proficiency of using chopsticks with the non-dominant hand, as well as the brain activity underlying changes in skill, remain unclear. This study characterised the effect of time spent training in chopstick operation with the non-dominant hand on chopstick-use proficiency and the related brain activity to obtain data that may help individuals who are obliged to change handedness due to neurological disease to learn to use their non-dominant hand in performing daily activities. Thirty-two healthy right-handed students were randomly allocated to training (n = 16) or control (n = 16) groups; the former received 6 weeks of training in chopstick use with their non-dominant (left) hand, and the latter received none. After training, significant improvements in the execution speed and smoothness of upper extremity joints were observed in the training group. Moreover, left dorsolateral prefrontal cortex activity significantly decreased, and bilateral premotor cortex activity significantly increased across training. These results indicated that 6 weeks of chopstick training with the non-dominant hand effectively improved chopstick operation.",2019,"Moreover, left dorsolateral prefrontal cortex activity significantly decreased, and bilateral premotor cortex activity significantly increased across training.",['Thirty-two healthy right-handed students'],['time spent training'],"['bilateral premotor cortex activity', 'chopstick operation', 'execution speed and smoothness of upper extremity joints', 'brain activity', 'left dorsolateral prefrontal cortex activity']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0228202', 'cui_str': 'Premotor Area'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]",32.0,0.0110905,"Moreover, left dorsolateral prefrontal cortex activity significantly decreased, and bilateral premotor cortex activity significantly increased across training.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sawamura', 'Affiliation': 'Department of Functioning and Disability, Faculty of Health Sciences, Hokkaido University, Hokkaido, Japan. D.sawamura@pop.med.hokudai.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sakuraba', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Occupational therapy, Yamagata Prefectural University of Health Sciences, Yamagata, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Asano', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Honke', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Iwase', 'Affiliation': 'Department of Rehabilitation Sciences, Health Sciences University of Hokkaido, Hokkaido, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Horimoto', 'Affiliation': 'Department of Physical Therapy, Chiba prefectural university of health sciences, Chiba, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Functioning and Disability, Faculty of Health Sciences, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Department of Functioning and Disability, Faculty of Health Sciences, Hokkaido University, Hokkaido, Japan.'}]",Scientific reports,['10.1038/s41598-019-56956-0']
1849,29443399,Two-Year Neurodevelopment and Growth Outcomes for Preterm Neonates Who Received Low-Dose Intravenous Soybean Oil.,"BACKGROUND


In some studies, the dose of intravenous soybean oil (SO) has been associated with a decreased incidence of intestinal failure-associated liver disease. The effect of lipid sparing on neurodevelopment (ND) and growth remains unknown. This study investigated the impact of SO dose on ND and growth over the first 2 years of age in preterm neonates.
MATERIALS AND METHODS


This is a single-site prospective follow-up study. Neonates with a gestational age ≤29 weeks were randomized to low-dose (LOW) or standard-dose (CON) SO. Bayley Scales of Infant Development III and anthropometric measurements were collected at approximately 6, 12, and 24 months corrected gestational age.
RESULTS


Subjects were premature, with a mean (±SD) gestational age of 28 ± 1 and 27 ± 1 weeks (P = .3) for LOW and CON, respectively. Thirty subjects completed follow-up (LOW = 15, CON = 15). There were no differences for ND and growth outcomes when LOW was compared with CON, with the exception of a higher 12-month follow-up cognitive scaled score in the LOW group (P = .02).
CONCLUSION


A reduced SO dose did not adversely affect ND or growth in this cohort of preterm neonates. However, larger studies are needed to determine the long-term safety of SO dose reduction before this strategy can be adopted.",2018,"There were no differences for ND and growth outcomes when LOW was compared with CON, with the exception of a higher 12-month follow-up cognitive scaled score in the LOW group (P = .02).
","['Preterm Neonates', 'preterm neonates', 'Neonates with a gestational age ≤29 weeks']","['intravenous soybean oil (SO', 'low-dose (LOW) or standard-dose (CON', 'Low-Dose Intravenous Soybean Oil', 'lipid sparing']","['Bayley Scales of Infant Development III and anthropometric measurements', 'ND and growth outcomes']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]","[{'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.154931,"There were no differences for ND and growth outcomes when LOW was compared with CON, with the exception of a higher 12-month follow-up cognitive scaled score in the LOW group (P = .02).
","[{'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Ong', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Isabell B', 'Initials': 'IB', 'LastName': 'Purdy', 'Affiliation': ""Neonatal Research Center of the UCLA Children's Discovery and Innovation Institute, Division of Neonatology and Developmental Biology, Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California, USA.""}, {'ForeName': 'Orly L', 'Initials': 'OL', 'LastName': 'Levit', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Robinson', 'Affiliation': 'Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Grogan', 'Affiliation': 'Statistics Core, Department of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Martiniano', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Calkins', 'Affiliation': ""Neonatal Research Center of the UCLA Children's Discovery and Innovation Institute, Division of Neonatology and Developmental Biology, Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California, USA.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1177/0148607116674482']
1850,31374208,Pre-EDIT: A Randomized Feasibility Trial of Elastance-Directed Intrapleural Catheter or Talc Pleurodesis in Malignant Pleural Effusion.,"BACKGROUND


Talc slurry pleurodesis (TSP) prevents recurrence of symptomatic malignant pleural effusion (MPE) in 71% to 78% patients. Nonexpansile lung (NEL) frequently accounts for TSP failure but is often occult predrainage, impairing selection of patients. NEL is associated with high pleural elastance (P EL ), but technical limitations have hampered the development of P EL  as a predictive NEL marker. We performed a single-center, randomized, controlled, open-label feasibility trial of EDIT (elastance-directed indwelling pleural catheter or TSP) management, using a novel digital manometer and a new definition of high P EL .
METHODS


Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved P EL  assessment during large-volume thoracentesis; patients with high P EL  (maximum P EL  sustained over 250 mL [MaxP EL250 ] ≥ 14.5 cm H 2 O/L) were allocated to immediately receive an indwelling pleural catheter; the remainder underwent immediate drain placement for TSP. The primary outcome measure was recruitment feasibility, defined a priori as 30 patients over 12 months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high P EL . The accuracy of the P EL  definition for NEL was analyzed post hoc.
RESULTS


Thirty-one patients were randomized (one allocation failure) over 12 months. P EL  assessment (mean duration, 33 minutes) was successful in 13 of 15 patients (87%). No directly attributable serious adverse events occurred. High P EL  was detected in seven of 13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325 mL (range, 250-800 mL).
CONCLUSIONS


A phase 3 trial testing the effect of EDIT management on symptomatic MPE recurrence following TSP is feasible.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03319186; URL: www.clinicaltrials.gov.",2019,"High P EL  was detected in 7/13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325ml (range 250ml-800ml).
","['Patients with symptomatic MPE', '31 patients', 'Malignant Pleural Effusion']","['EDIT (Elastance-directed indwelling pleural catheter (IPC) or TSP', 'Talc Slurry Pleurodesis (TSP', 'Elastance-Directed Intrapleural catheter or Talc Pleurodesis (EDIT', 'Pre-EDIT', 'immediate drain placement for TSP', 'TSP', 'NEL', 'EDIT and Standard Care (TSP', 'EDIT management']","['recurrence of symptomatic Malignant Pleural Effusion (MPE', 'High P EL', 'symptomatic MPE recurrence', 'safety, technical reliability and the aspiration volume required to detect high P EL ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C1322293', 'cui_str': 'Pleural catheter (physical object)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0405997', 'cui_str': 'Talc pleurodesis (procedure)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",31.0,0.194399,"High P EL  was detected in 7/13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325ml (range 250ml-800ml).
","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Martin', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Tsim', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Kidd', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Foster', 'Affiliation': 'Glasgow Clinical Research Imaging Facility, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McLoone', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chalmers', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. Electronic address: kevin.blyth@glasgow.ac.uk.'}]",Chest,['10.1016/j.chest.2019.07.010']
1851,31476161,"Clinical Benefits of Antioxidative Supplement Twendee X for Mild Cognitive Impairment: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Prospective Interventional Study.","Oxidative stress is part of the entire pathological process that underlies the development of Alzheimer's disease (AD), including the mild cognitive impairment (MCI) stage. Twendee X (TwX) is a supplement containing a strong antioxidative mix of eight antioxidants, which has been shown to have a clinical and therapeutic benefit in AD model mice. Here, we conducted a multicenter, randomized, double-blind, and placebo-controlled prospective interventional study to evaluate the efficacy of TwX in mitigating MCI. The primary outcomes were differences in Mini-Mental State Examination (MMSE) and Hasegawa Dementia Scale-revised (HDS-R) scores between baseline and six months for placebo and TwX groups. Seventy-eight subjects with MCI were randomized into placebo (n = 37) and TwX (n = 41) groups. MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025). The TwX group did not show any change in affective or activities of daily living scores at six months. The present study indicates that strong antioxidative supplement TwX is clinical beneficial for cognitive function in subjects with MCI.",2019,"MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025).","['Seventy-eight subjects with MCI', 'Mild Cognitive Impairment', 'subjects with MCI']","['Antioxidative Supplement Twendee X', 'TwX and placebo', 'placebo', 'Twendee X (TwX', 'TwX', 'Placebo']","['Mini-Mental State Examination (MMSE) and Hasegawa Dementia Scale-revised (HDS-R) scores', 'MMSE scores', 'HDS-R scores', 'affective or activities of daily living scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",78.0,0.543298,"MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025).","[{'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Tadokoro', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Morihara', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Hishikawa', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Kawano', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sasaki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Namiko', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Setsuko', 'Initials': 'S', 'LastName': 'Ueno', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Wakutani', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Takao', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Nobutoshi', 'Initials': 'N', 'LastName': 'Morimoto', 'Affiliation': 'Department of Neurology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kutoku', 'Affiliation': 'Department of Neurology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Sunada', 'Affiliation': 'Department of Neurology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Katsushi', 'Initials': 'K', 'LastName': 'Taomoto', 'Affiliation': 'Department of Neurosurgery, Ohnishi Neurological Center, Akashi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Manabe', 'Affiliation': 'Department of Neurology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Deguchi', 'Affiliation': 'Department of Neurology, Okayama City Hospital, Okayama, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Neurology, Himeji Central Hospital, Himeji, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Inufusa', 'Affiliation': 'Division of Anti-Oxidant Research, Life Science Research Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Fukka', 'Initials': 'F', 'LastName': 'You', 'Affiliation': 'Division of Anaerobe Research, Life Science Research Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Louis Pasteur Center for Medical Research, Kyoto, Japan.'}, {'ForeName': 'Markus Matuschka', 'Initials': 'MM', 'LastName': 'von Greiffenclau', 'Affiliation': 'European Medical Foundation, TIMA Est., Balzers, Liechtenstein.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190644']
1852,31953787,Efficacy of submucosal tramadol and lidocaine on success rate of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis.,"The aim of the present study is to compare the efficacy of additional 100 mg/2 ml tramadol and 40 mg/2 ml lidocaine applications on the anesthetic success of inferior alveolar nerve block (IANB) in mandibular molars with symptomatic irreversible pulpitis (MM-SIP). One hundred and five patients diagnosed with symptomatic pulpitis in the lower first or second molars were included in the study. Patients were randomly divided into three groups (n = 35) composed of control and two experimental groups administered submucosal tramadol and lidocaine. Preoperative pain levels of the patients were measured with Heft-Parker visual analog scale (HP VAS). Following, standard IANB with 2% lidocaine 1: 80,000 was administrated to all groups. After observation of lip numbness, 2 ml of saline in the control group, 100 mg/2 ml tramadol in tramadol group and 40 mg/2 ml (2%, 1: 80,000) lidocaine in lidocaine group were administered submucosally. After 15 min, standard endodontic treatment was initiated and the pain levels measured from access cavity preparation to pulp extirpation were measured with HP VAS. The success rate of pulpal anesthesia was 28.5% in the control group, 45.7% in the submucosal lidocaine group and 48.6% in the tramadol group. There was no statistically significant difference in the success rate between the groups. Additional submucosal administration of 100 mg tramadol did not significantly increase the success of IANB applied with a combination of 2% lidocaine 1:80,000 and epinephrine in MM-SIP compared to control group.",2020,"Additional submucosal administration of 100 mg tramadol did not significantly increase the success of IANB applied with a combination of 2% lidocaine 1:80,000 and epinephrine in MM-SIP compared to control group.","['One hundred and five patients diagnosed with symptomatic pulpitis in the lower first or second molars were included in the study', 'mandibular molars with symptomatic irreversible pulpitis', 'mandibular molars with symptomatic irreversible pulpitis (MM-SIP']","['submucosal tramadol and lidocaine', 'ml lidocaine', 'tramadol in tramadol', 'submucosal lidocaine', 'additional 100\xa0mg/2\xa0ml tramadol and 40\xa0mg/2', 'tramadol', 'epinephrine', 'lidocaine']","['Heft-Parker visual analog scale (HP VAS', 'success rate of pulpal anesthesia', 'success of IANB', 'success rate', 'success rate of inferior alveolar nerve block', 'anesthetic success of inferior alveolar nerve block (IANB', 'Preoperative pain levels', 'pain levels']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0034103', 'cui_str': 'Inflammation, Endodontic'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis (disorder)'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",105.0,0.0930549,"Additional submucosal administration of 100 mg tramadol did not significantly increase the success of IANB applied with a combination of 2% lidocaine 1:80,000 and epinephrine in MM-SIP compared to control group.","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Aksoy', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey. dr.f.aksoy@gmail.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}]",Odontology,['10.1007/s10266-020-00485-0']
1853,31845903,An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework.,"BACKGROUND


Due to a resurgent debate on the misuse of P values, the Journal of Medical Internet Research is hosting a standing theme issue inviting the reanalysis of (primarily digital health) trial data using a Bayesian framework. This first paper in this series focuses on an electronic screening and brief intervention (eSBI), targeting harmful and hazardous alcohol consumption, which student health care centers across Sweden have routinely administerd to all students during the past decade. The second Alcohol Email Assessment and Feedback Study Dismantling Effectiveness for University Students (AMADEUS-2) trial aimed to assess the effect of the eSBI on alcohol consumption among students who were harmful and hazardous drinkers. A two-arm randomized controlled trial design was employed, randomizing eligible participants to either a waiting list or direct access to an eSBI. Follow-up assessments were conducted 2 months after randomization. Subsequent analysis of the trial followed the conventional null hypothesis approach, and no statistical significance was found between groups at follow-up with respect to the number of standard drinks consumed weekly. However, in an unspecified sensitivity analysis, it was discovered that removing three potential outliers made the difference between the groups significant.
OBJECTIVE


The objective of this study is to reperform the primary and sensitivity analysis of the AMADEUS-2 trial using a Bayesian framework and to compare the results with those of the original analysis.
METHODS


The same regression models used in the original analysis were employed in this reanalysis (negative binomial regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest.
RESULTS


Null hypothesis tests did not identify a statistically significant difference between the intervention and control groups, potentially due to a few extreme data points. The Bayesian analysis indicated a 93.6% probability that there was a difference in grams of alcohol consumed at follow-up between the intervention and control groups and a 71.5% probability that the incidence rate ratio was <0.96. Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students.
CONCLUSIONS


The null hypothesis framework relies on point estimates of parameters. P values can therefore swing heavily, depending on a single or few data points alone, casting doubt on the value of the analysis. Bayesian analysis results in a distribution over parameter values and is therefore less sensitive to outliers and extreme values. Results from analyses of trials of interventions where small-to-modest effect sizes are expected can be more robust in a Bayesian framework, making this a potentially better approach for analyzing digital health research data.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 02335307; http://www.isrctn.com/ISRCTN02335307.",2019,"Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students.
","['randomizing eligible participants to either a waiting list or direct access to an eSBI', 'student health care centers across Sweden have routinely administerd to all students during the past decade', 'students who were harmful and hazardous drinkers', 'Hazardous and Harmful Drinking Among Swedish University Students', 'University Students']","['eSBI', 'Electronic Screening and Brief Intervention', 'electronic screening and brief intervention (eSBI']","['alcohol consumption', 'grams of alcohol', 'Posterior probabilities', 'incidence rate ratio']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0931566,"Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students.
","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",Journal of medical Internet research,['10.2196/14420']
1854,31832621,A crowdsourced intervention to promote hepatitis B and C testing among men who have sex with men in China: A nationwide online randomized controlled trial.,"Background


Crowdsourcing may be an effective strategy to develop test promotion materials. We conducted an online randomized controlled trial (RCT) to evaluate a crowdsourced intervention to promote hepatitis B virus (HBV) and hepatitis C virus (HCV) testing among men who have sex with men (MSM) in China.
Methods


MSM never previously tested for hepatitis were recruited through social media. Eligible men were randomized to receive an online crowdsourced intervention or no testing promotion materials. Outcomes including self-reported and confirmed HBV and HCV test uptake were assessed after four weeks. Odds ratios (OR) with 95% confidence intervals (95% CI) of men achieving primary and secondary outcomes between the intervention and control arms were calculated.
Findings


556 eligible men were enrolled. Overall, 17•4% (97/556) of men self-reported HBV and HCV testing and 7•9% (44/556) confirmed HBV and HCV test uptake. The intervention was seen by 72•1% and 29•0% of men in the intervention and control arms, respectively. In intention-to-treat analysis, confirmed HBV and HCV test uptake was similar between the two arms, both when using a missing=failure approach (OR 0•98, 95% CI 0•53-1•82) or multiple imputation (OR 1•46, 95% CI 0•72-2•95).
Interpretation


This RCT extends the literature by developing and evaluating an intervention to spur hepatitis testing in a middle-income country with a high burden of hepatitis. Overall test uptake among MSM in China was similar to previous interventions promoting hepatitis testing in high-income countries. We found frequent intervention sharing, complicating interpretation of the results, and the role of crowdsourcing to promote hepatitis testing remains unclear.",2019,"In intention-to-treat analysis, confirmed HBV and HCV test uptake was similar between the two arms, both when using a missing=failure approach (OR 0•98, 95% CI 0•53-1•82) or multiple imputation (OR 1•46, 95% CI 0•72-2•95).
","['men who have sex with men (MSM) in China', 'men who have sex with men in China', 'Findings\n\n\n556 eligible men were enrolled', 'Eligible men']","['crowdsourced intervention', 'crowdsourced intervention to promote hepatitis B virus (HBV) and hepatitis C virus (HCV) testing', 'online crowdsourced intervention or no testing promotion materials']","['self-reported and confirmed HBV and HCV test uptake', 'HBV and HCV test uptake', 'Odds ratios (OR']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",556.0,0.245388,"In intention-to-treat analysis, confirmed HBV and HCV test uptake was similar between the two arms, both when using a missing=failure approach (OR 0•98, 95% CI 0•53-1•82) or multiple imputation (OR 1•46, 95% CI 0•72-2•95).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'UNC Project China, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'UNC Project China, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Po-Lin', 'Initials': 'PL', 'LastName': 'Chan', 'Affiliation': 'Division of Communicable Disease, World Health Organization Western Pacific Regional Office, Manila, Philippines.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'School of Sociology and Anthropology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Center for Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'William Cw', 'Initials': 'WC', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, Hong Kong University, Hong Kong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'UNC Project China, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",EClinicalMedicine,['10.1016/j.eclinm.2019.10.007']
1855,31490310,Quantification of Erythema Associated With Continuous Versus Interrupted Nylon Sutures in Facial Surgery Repair: A Randomized Prospective Study.,"BACKGROUND


Patients are often concerned about the cosmetic appearance of scars following Mohs micrographic surgery (MMS), including residual erythema. However, few studies have compared the cosmetic outcomes between different suturing techniques.
OBJECTIVE


To compare the erythema intensity (EI) associated with interrupted sutures (IS) and continuous sutures (CS), and the degree of its reduction over time.
MATERIALS AND METHODS


Mohs micrographic surgery patients were randomized to have half of their defect repaired with IS and the other half with CS. Postoperatively, subjects were assessed at 1 week, 2 months, and 6 months and close-up photographs of their scars were taken. Computer-assisted image analysis was utilized to quantify the EI in each half-scar.
RESULTS


The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months. These differences were clinically detectable, but EI differences resolved by 6 months in most cases. At 6 months, EI regressed by 33.5% in IS and 26.3% in CS.
CONCLUSION


Continuous sutures are associated with less erythema during early scar maturation but are comparable to IS at 6 months. These results may guide the choice of suturing technique to improve early cosmetic outcomes and overall patient satisfaction.",2020,The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months.,"['Facial Surgery Repair', 'Mohs micrographic surgery patients']","['micrographic surgery (MMS', 'interrupted sutures (IS) and continuous sutures (CS', 'Continuous Versus Interrupted Nylon Sutures']","['Quantification of Erythema', 'average EI of IS', 'erythema during early scar maturation', 'erythema intensity (EI']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0183734', 'cui_str': 'Nylon suture, device (physical object)'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0281273,The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Majd', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ardalan', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002145']
1856,31490431,Training Prescription Guided by Heart Rate Variability Vs. Block Periodization in Well-Trained Cyclists.,"Javaloyes, A, Sarabia, JM, Lamberts, RP, Plews, D, and Moya-Ramon, M. Training prescription guided by heart rate variability vs. block periodization in well-trained cyclists. J Strength Cond Res 34(6): 1511-1518, 2020-Predefined training programs are common place when prescribing training. Within predefined training, block periodization (BP) has emerged as a popular methodology because of its benefits. Heart rate variability (HRV) has been proposed as an effective tool for prescribing training. The aim of this study is to examine the effect of HRV-guided training against BP in road cycling. Twenty well-trained cyclists participated in this study. After a preliminary baseline period to establish their resting HRV, cyclists were divided into 2 groups: an HRV-guided group and a BP group, and they completed 8 training weeks. Cyclists completed 3 evaluations weeks, before and after each period. During the evaluation weeks, cyclists performed: (a) a graded exercise test to assess V[Combining Dot Above]O2max, peak power output (PPO), and ventilatory thresholds with their corresponding power output (VT1, VT2, WVT1, and WVT2, respectively) and (b) a 40-minute simulated time-trial (40 TT). The HRV-guided group improved V[Combining Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04). The BP group improved WVT2 (p = 0.02). Between-group fitness and performance were similar after the study. The HRV-guided training could lead to a better timing in training prescription than BP in road cycling.",2020,"Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04).","['Twenty well-trained cyclists participated in this study', 'Well-Trained Cyclists', ' 000-000']","['HRV-guided group and a BP', 'HRV-guided training against BP', 'graded exercise test to assess', 'HRV-guided group improved V[Combining', 'V[Combining', 'J Strength Cond Res XX(X']","['PPO', 'Dot Above]O2max, peak power output (PPO), and ventilatory thresholds with their corresponding power output (VT1, VT2, WVT1, and WVT2, respectively) and', 'Heart rate variability (HRV']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",40.0,0.058427,"Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Javaloyes', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Sarabia', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lamberts', 'Affiliation': 'Division of Orthopaedic Surgery, Institute of Sport and Exercise Medicine (ISEM), Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Plews', 'Affiliation': 'Sport Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramon', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003337']
1857,31483750,Application of an innovative high-throughput liquid chromatography-tandem mass spectrometry method for simultaneous analysis of 18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers.,"OBJECTIVES


Despite safe handling guidelines published by several groups, health care worker exposure to hazardous drugs continues to occur due to suboptimal engineering controls and low use of protective equipment. Simple, multi-target and specific analytical methods are needed so that acute exposures to these drugs in the workplace can be assessed rapidly. Our aim was to develop an analytical method for simultaneous detection and quantification of widely used cancer drugs to rule out accidental acute chemotherapy exposures in health care workers.
METHODS


We examined the feasibility of alternate high-performance liquid chromatographic-tandem mass spectrometry methods to simultaneously detect eighteen chemotherapy analytes in plasma and urine. The linear concentration ranges tested during assay development were 0.1-50 ng/mL. After development of a multi-analyte assay protocol, plasma samples (n = 743) from a multi-center cluster-randomized clinical trial (n = 12 sites) of an hazardous drug educational intervention were assayed. Confirmatory assays were performed based on the individual acute-spill case-histories.
RESULTS


An innovative HPLC-multiple reaction monitoring-information dependent acquisition-enhanced production ion (MRM-IDA-EPI) analytical method was developed to simultaneously detect: cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel. The retention times ranged from 4 min to 13 min for the analytical run. The limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM) was 0.25 ng/mL and 0.1 ng/mL, respectively for most analytes. No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills. Use of a secondary tandem mass spectrometry approach was able to successfully rule out false positive results.
CONCLUSIONS


Development of a sensitive high-throughput multi-analyte cancer chemotherapy assay is feasible using an MRM-IDA-EPI method. This method can be used to rapidly rule out systemic exposure to accidental acute chemotherapy spills in health care workers.",2020,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","['18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers', 'accidental acute chemotherapy spills in health care workers']","['innovative high-throughput liquid chromatography-tandem mass spectrometry method', 'hazardous drug educational intervention', 'cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel']","['limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM', 'detectable plasma concentrations']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",743.0,0.0773291,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Shu', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Duxin', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Friese', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219870591']
1858,30664725,VCAP-AMP-VECP as a preferable induction chemotherapy in transplant-eligible patients with aggressive adult T-cell leukemia-lymphoma: a propensity score analysis.,"A dose-intensified multi-agent chemotherapy regimen called VCAP-AMP-VECP was investigated in Japan as front-line therapy for patients with adult T-cell leukemia-lymphoma (ATL). Although a prospective randomized controlled study showed that VCAP-AMP-VECP was superior to CHOP, the trial was rather small and no subsequent studies confirmed the benefit of VCAP-AMP-VECP over CHOP. We conducted a retrospective analysis of transplant-eligible patients with ATL who received only VCAP-AMP-VECP or CHOP, incorporating inverse probability of treatment weighting (IPTW) using propensity scoring. Overall, 947 and 513 patients were treated with VCAP-AMP-VECP and CHOP, respectively. The median follow-up of surviving patients was 1006 days. The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001). Stratified by risk group according to the modified ATL-prognostic index score at diagnosis, the crude probabilities of 2-year OS in the VCAP-AMP-VECP and CHOP groups were 39.8 and 45.0% in the low-risk group (P = 0.69), 32.2 and 21.6% in the intermediate-risk group (P < 0.001), and 17.2 and 6.2% in the high-risk group (P = 0.005). Our current analysis suggests that VCAP-AMP-VECP regimen is a preferable front-line therapy in patients with aggressive ATL in intermediate- and high-risk groups.",2019,"The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001).","['transplant-eligible patients with aggressive adult T-cell leukemia-lymphoma', 'transplant-eligible patients with ATL who received only', 'patients with aggressive ATL in intermediate- and high-risk groups', 'patients with adult T-cell leukemia-lymphoma (ATL']","['VCAP-AMP-VECP', 'VCAP-AMP-VECP or CHOP, incorporating inverse probability of treatment weighting (IPTW']",['crude probabilities of 2-year overall survival (OS'],"[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023493', 'cui_str': 'ATLL'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0327527,"The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001).","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Fuji', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan. fujishige1231@gmail.com.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Atae', 'Initials': 'A', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Hematology, Imamura General Hospital, Kagoshima, Japan.'}, {'ForeName': 'Yukiyoshi', 'Initials': 'Y', 'LastName': 'Moriuchi', 'Affiliation': 'Department of Hematology, Sasebo City General Hospital, Sasebo, Japan.'}, {'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Owatari', 'Affiliation': 'Department of Hematology, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Hematology, Heart-Life Hospital, Okinawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sawayama', 'Affiliation': 'Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Otsuka', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.'}]",Bone marrow transplantation,['10.1038/s41409-019-0446-z']
1859,31859347,Mindfulness Versus Distraction to Improve Affective Response and Promote Cardiovascular Exercise Behavior.,"BACKGROUND


Variation in affective response to exercise partially explains high levels of inactivity. Examining ways to improve affective responses to physical activity is, therefore, an important direction for research aiming to promote exercise behavior.
PURPOSE


This study compares three strategies: mindfulness, distraction, and an associative focus comparison group as potential strategies to improve affective response to exercise and promote exercise behavior.
METHODS


Seventy-eight insufficiently active individuals (M age 26.82, 74% female) were randomly assigned to one of the following three conditions: (a) mindfulness, (b) distraction, or (c) associative attentional focus. The study was divided into two phases, a laboratory session in which participants learned their assigned strategy and completed a 30 min supervised exercise bout and an at-home intervention in which participants used their assigned strategy while exercising on their own for 2 weeks and filled out daily surveys.
RESULTS


Seventy-five participants completed the study. The central hypotheses were partially supported. Participants in the mindfulness and distraction conditions maintained more positive affective response to exercise over time compared to participants in the associative focus condition, whose affect became less positive over time (p = .04). Participants in the distraction condition experienced lower perceived exertion during exercise (p = .01). There were no condition differences in self-reported minutes exercised during follow-up, but participants in the mindfulness condition reported exercising for more days during the follow-up compared to the associative focus condition (p = .01).
CONCLUSIONS


These findings suggest individuals wishing to increase their cardiovascular exercise could engage in mindfulness or distraction in order to make exercise feel less difficult and/or more affectively pleasant.",2020,"Participants in the mindfulness and distraction conditions maintained more positive affective response to exercise over time compared to participants in the associative focus condition, whose affect became less positive over time (p = .04).","['Seventy-eight insufficiently active individuals (M age 26.82, 74% female', 'Seventy-five participants completed the study']","['mindfulness, (b) distraction, or (c) associative attentional focus', 'Mindfulness Versus Distraction', '30 min supervised exercise bout and an at-home intervention in which participants used their assigned strategy while exercising on their own for 2 weeks and filled out daily surveys']","['positive affective response', 'Affective Response and Promote Cardiovascular Exercise Behavior']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",78.0,0.020913,"Participants in the mindfulness and distraction conditions maintained more positive affective response to exercise over time compared to participants in the associative focus condition, whose affect became less positive over time (p = .04).","[{'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Gillman', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz059']
1860,31485965,A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.,"BACKGROUND


There is a need for new strategies to improve the success of obesity treatment within the primary care setting.
OBJECTIVE


To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care.
DESIGN


Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital.
PARTICIPANTS


From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention.
INTERVENTIONS


Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months.
MAIN MEASURES


The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss.
KEY RESULTS


Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes.
CONCLUSIONS


Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT01922934.",2019,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"['Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital', 'From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention', 'Urban Safety-Net Primary Care Clinics']",[],"['Mean percentage weight loss', 'proportion of on-treatment patients who achieved ≥\u20095% weight loss', 'proportion of intervention-eligible patients who achieved ≥\u20095% weight loss', 'weight loss']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",428.0,0.0583472,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Saxon', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. david.saxon@ucdenver.edu.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Tsai', 'Affiliation': 'Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Speer', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Heyn', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kealey', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05222-0']
1861,31482294,Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study.,"PURPOSE


In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa).
METHODS


Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ 2  test, Student's t test, and analysis of variance.
RESULTS


From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05).
CONCLUSIONS


Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.",2020,"Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.","['patients with prostate cancer (PCa', 'Eligible patients', 'patients with prostate cancer', '100 patients registered, 85 completed the trial (degarelix: 40 patients', 'Patients with hormone-naive PCa were recruited']","['androgen deprivation therapy (ADT', 'orchiectomy and leuprolide', 'leuprolide', 'degarelix or monthly leuprolide', 'ADT with degarelix or leuprolide', 'degarelix vs leuprolide plus bicalutamide', 'degarelix']","['metabolic syndrome', 'Follicle-stimulating hormone levels', 'body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas', 'FSH levels', 'FBS', 'changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels', 'Lipid and glucose metabolism', 'least metabolic consequences via low follicle-stimulating hormone (FSH) levels', 'fasting blood sugar (FBS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0029189', 'cui_str': 'Orchidectomy'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",85.0,0.051307,"Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.","[{'ForeName': 'Harutake', 'Initials': 'H', 'LastName': 'Sawazaki', 'Affiliation': 'Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan. harutake_sawazaki@tokyo-hmt.jp.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Araki', 'Affiliation': 'Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Department of Urology, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Yagi', 'Affiliation': 'Department of Urology, National Defense Medical College, Tokorozawa, Japan.'}]",World journal of urology,['10.1007/s00345-019-02937-x']
1862,32434104,Effect of the mobile phone-related background on inhibitory control of problematic mobile phone use: An event-related potentials study.,"The present study aims to provide electrophysiological evidence for deficient inhibitory control in problematic mobile phone use and to investigate whether reduced inhibition is more pronounced during exposure to a mobile phone related background cue. A screen scale of smartphone addiction was completed by 227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study. Event-related potentials were recorded during a backgrounded Go/NoGo task performed by those two groups, in which either a frequent Go signal (letter ""M"") or a rare NoGo signal (letter ""W"") was superimposed on three different background cues: neutral, mobile phone application-related and mobile phone using-related pictures. Results showed that problematic mobile phone users performed more commission errors than controls following mobile phone application background. Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background. The result might suggest that there is no general impairment of inhibitory control in problematic mobile phone use. The deficient inhibitory control on behavioral and psychophysiological level appeared merely in the mobile phone-related background. Such deficient stimuli-specific inhibitory control appears at the late stage of inhibitory control. Prevention programs should be designed to curtail exposure to the mobile phone-related stimulus and enhance cognitive control of potential problematic mobile phone users.",2020,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","['227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study']",['mobile phone-related background'],"['behavioral and psychophysiological level', 'commission errors', 'NoGo P3 amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0394788,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","[{'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Jingfu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Qingbai', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Zongkui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China. Electronic address: zhouzk@mail.ccnu.edu.cn.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106363']
1863,31478095,"The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study.","To evaluate the effect of high-intensity laser therapy (HILT) in patients with calcaneal spur. The patients were randomized to receive either HILT + exercise (n = 21) (five times a week for a period of 3 weeks) or placebo HILT + exercise (n = 21) (five times a week for a period of 3 weeks). Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks. A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups. Besides, there was no significant difference in VAS (p > 0.05) and RMS (p > 0.05) between the groups. FAOS symptoms (p = 0.022) and quality of life (p = 0.038) subgroups were higher in the placebo group at 12 weeks. Significant improvements were observed in dynamic pedographic measurements in the HILT group (p < 0.05), and dynamic measurement values were significantly higher in the HILT group compared to placebo group (p < 0.05). Although the evaluation parameters, except dynamic pedographic measurements, have improved in both groups, our study results showed no superiority of HILT over placebo. To conclude, when the main complaint is pain in patients, only exercise therapy can be an economical, practical, and reliable treatment.",2020,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","['painful calcaneal spur', 'patients with calcaneal spur']","['HILT\u2009+\u2009exercise', 'HILT', 'high-intensity laser therapy (HILT', 'placebo', 'high intensity laser therapy', 'placebo HILT\u2009+\u2009exercise']","['FAOS subgroup scores', 'FAOS symptoms', 'SF-36 subgroup scores', 'Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36', 'quality of life', 'VAS', 'dynamic measurement values', 'RMS', 'dynamic pedographic measurements']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal Spur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.201732,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","[{'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Yesil', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey. dradanur@yahoo.com.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Dundar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Toktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Eyvaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Yeşil', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}]",Lasers in medical science,['10.1007/s10103-019-02870-w']
1864,31475391,Health visitors' competences before and after implementing the newborn behavioral observations (NBO) system in a community setting: A cluster randomised study.,"OBJECTIVE


To explore differences between health visitors' competences before and after implementing the newborn behavioral observations (NBO) system in four Danish municipalities.
DESIGN AND SAMPLE


In a cluster randomized design, 56 and 55 health visitors were enrolled in the intervention and comparison districts. Only health visitors from the intervention district received the NBO education programme.
MEASUREMENTS


Data from self-administered questionnaires on heath visitors' intention, self-efficacy, knowledge, and observation skills were collected before and after NBO training. Data were analysed using descriptive and multivariable analyses.
RESULTS


Health visitors reported high levels of intention, self-efficacy, and knowledge working with early parent-infant relationships in both groups at baseline. After implementing NBO, the intervention health visitors reported a significantly higher level of knowledge of infant self-regulation than the comparison group. No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
CONCLUSIONS


Health visitors attending the NBO education and working with NBO in clinical practise had a significantly higher level of knowledge of infant self-regulation. A new discussion of how to educate health visitors' competencies working with early relationship in clinical practise is needed.",2019,"No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
","['four Danish municipalities', '56 and 55 health visitors were enrolled in the intervention and comparison districts']",[],"['levels of intention, self-efficacy, and knowledge working with early parent-infant relationships', ""heath visitors' intention, self-efficacy, knowledge, and observation skills"", ""health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship"", 'level of knowledge of infant self-regulation']","[{'cui': 'C0600182'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]",,0.0413392,"No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
","[{'ForeName': 'Ingeborg H', 'Initials': 'IH', 'LastName': 'Kristensen', 'Affiliation': 'Section for Nursing, Department of Public Health, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Vinter', 'Affiliation': 'Health Department, Thisted, Denmark.'}, {'ForeName': 'Inge K', 'Initials': 'IK', 'LastName': 'Nickell', 'Affiliation': 'The Brazelton Centre UK, Cambridge, UK.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Section for Nursing, Department of Public Health, Aarhus University, Aarhus C, Denmark.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12658']
1865,31307883,"Intermittent preventive treatment with dihydroartemisinin-piperaquine and risk of malaria following cessation in young Ugandan children: a double-blind, randomised, controlled trial.","BACKGROUND


Intermittent preventive treatment (IPT) of malaria with dihydroartemisinin-piperaquine is a promising strategy for malaria prevention in young African children. However, the optimal dosing strategy is unclear and conflicting evidence exists regarding the risk of malaria after cessation of chemoprevention. We aimed to compare two dosing strategies of IPT with dihydroartemisinin-piperaquine in young Ugandan children, and to evaluate the risk of malaria after cessation of IPT.
METHODS


In this double-blind, randomised controlled phase 2 trial, women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda). Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks). Women and their unborn children were randomly assigned (1:1:1:1) to one of four treatment groups, all receiving dihydroartemisinin-piperaquine, on the basis of the IPT intervention received by the woman during pregnancy: women every 8 weeks, children every 4 weeks; women every 4 weeks, children every 4 weeks; women every 8 weeks, children every 12 weeks; and women every 4 weeks, children every 12 weeks. Block randomisation was done by an independent investigator using a computer-generated randomisation list (permuted block sizes of six and 12). We analysed children on the basis of their random assignment to receive dihydroartemisinin-piperaquine (20 mg/160 mg tablets) once daily for 3 consecutive days every 4 weeks or 12 weeks. Children received study drugs from age 8 weeks to 24 months and were followed-up to age 36 months. Participants and investigators were masked to treatment allocation. The primary outcome was the incidence of symptomatic malaria during the intervention and following cessation of the intervention, adjusted for potential confounders. The primary outcome and safety were assessed in the modified intention-to-treat population, which included all children who reached 8 weeks of age and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02163447.
FINDINGS


Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group). During the intervention, the incidence of symptomatic malaria was significantly lower among children treated every 4 weeks than children treated every 12 weeks; three episodes occurred among children treated every 4 weeks (incidence 0·018 episodes per person-year) compared with 61 episodes among children treated every 12 weeks (incidence 0·39 episodes per person-year; adjusted incidence rate ratio [aIRR] 0·041, 95% CI 0·012-0·150, p<0·0001). After cessation of IPT, children who had previously received dihydroartemisinin-piperaquine every 4 weeks had a lower incidence of symptomatic malaria than children who were treated every 12 weeks; 62 episodes occurred among children previously treated every 4 weeks (incidence 0·73 episodes per person-year) compared with 83 episodes among children treated every 12 weeks (incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028). In the 4-week group, 94 (98%) of 96 children had adverse events versus 87 (100%) of 87 children in the 12-week group. The most commonly reported adverse event was cough in both treatment groups (94 [98%] in the 4-week group vs 87 [100%] in the 12-week group). 16 children had severe adverse events (seven [7%] children in the 4-week group vs nine [10%] children in the 12-week group). No severe adverse events were thought to be related to study drug administration. One death occurred during the intervention (age 8 weeks to 24 months), which was due to respiratory failure unrelated to malaria.
INTERPRETATION


IPT with dihydroartemisinin-piperaquine given every 4 weeks was superior to treatment every 12 weeks for the prevention of malaria during childhood, and this protection was extended for up to 1 year after cessation of IPT.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development.",2019,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","['young African children', 'young Ugandan children', 'Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks', 'Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group', 'women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda', 'Women and their unborn children']","['IPT intervention', 'dihydroartemisinin-piperaquine', 'IPT with dihydroartemisinin-piperaquine', 'dihydroartemisinin-piperaquine and risk of malaria following cessation']","['incidence of symptomatic malaria', 'severe adverse events', 'One death', 'adverse events', 'symptomatic malaria', 'incidence rate ratio [aIRR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0443061', 'cui_str': 'Tororo (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",191.0,0.351502,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. Electronic address: marymkakuru@gmail.com.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Bishop', 'Initials': 'B', 'LastName': 'Opira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaffer', 'Initials': 'J', 'LastName': 'Okiring', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nalugo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Charlebois', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Feeney', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda; School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30299-3']
1866,31474435,Effects of a Sexual HIV Risk Reduction Intervention for African American Mothers and Their Adolescent Sons: A Randomized Controlled Trial.,"PURPOSE


The aim of the article was to test the efficacy of an HIV risk reduction intervention for African American mothers in reducing condomless vaginal intercourse among mothers and their adolescent sons.
METHODS


In a randomized controlled trial design, mother-son dyads residing in public housing developments in Philadelphia, PA, were allocated to one of two four-session interventions: HIV risk reduction targeting sexual risk behaviors or attention-matched control targeting other health behaviors. Only mothers received the interventions; mothers and sons completed self-report measures preintervention, immediately postintervention, and 3, 6, 12, 18, and 24 months postintervention. The primary outcome was frequency of condomless vaginal intercourse in the past 3 months.
RESULTS


A total of 525 mother-son dyads participated, with 523 included in primary outcome analyses. Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment. The intervention's efficacy did not differ between mothers and sons or among the postintervention periods.
CONCLUSIONS


Mother-son interventions are an effective strategy to reduce sexual risks among African American mothers and their adolescent sons residing in public housing.",2019,"Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment.","['African American mothers in reducing condomless vaginal intercourse among mothers and their adolescent sons', 'mother-son dyads residing in public housing developments in Philadelphia, PA', 'A total of 525 mother-son dyads participated, with 523 included in primary outcome analyses', 'African American mothers and their adolescent sons residing in public housing', 'African American Mothers and Their Adolescent Sons']","['HIV risk reduction intervention', 'Sexual HIV Risk Reduction Intervention', 'HIV risk reduction targeting sexual risk behaviors or attention-matched control targeting other health behaviors']","['HIV risk reduction intervention', 'frequency of condomless vaginal intercourse in the past 3\xa0months', 'sexual risks']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018687'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",525.0,0.0573804,"Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment.","[{'ForeName': 'Loretta Sweet', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania. Electronic address: jemmott@drexel.edu.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chittamuru', 'Affiliation': 'Public Health Department, School of Social Sciences, Humanities, and Arts, University of California, Merced, California.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Icard', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.05.017']
1867,30466547,Examining the influence of active ingredients of motivational interviewing on client change talk.,"Motivational Interviewing (MI) is an evidenced-based intervention designed to help clients explore and resolve ambivalence around substance use. MI combines a humanistic tradition with behavioral components to facilitate client decisions concerning behavior change. As such, there is marked interest in the relationship between the two active ingredients of MI - the relational, or person-centered, components and the technical, or directional, behavioral components - on client in-session language. Yet, few studies have examined how these active ingredients operate in concert. Therefore, the current study evaluated the constellation of relational skills associated with client language, as well as the influence of technical skills on the relationship between provider relational skills and client change language. Specifically, we tested a latent construct of relational skill and its direct association with the proportion of client change talk. We then explored the mediating role of reflections of change and sustain talk (RefCT and RefST) on this relationship. The data for this secondary analysis are from Project ELICIT (N = 131), a randomized control trial evaluating the effects of MI training on client change language. We found support for a latent construct of relational skill (i.e., empathy, acceptance, collaboration, and autonomy/support). However, the relational skill construct did not predict client change language. There was support for an indirect effect, such that relational skills predicted RefCT and RefST, and RefCT and RefST predicted client change language. These results suggest that the synergistic implementation of the relational and technical components of MI is critical to facilitating a higher percentage of change talk.",2019,Motivational Interviewing (MI) is an evidenced-based intervention designed to help clients explore and resolve ambivalence around substance use.,[],"['MI training', 'motivational interviewing', 'Motivational Interviewing (MI']",['client change language'],[],"[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]",,0.0173149,Motivational Interviewing (MI) is an evidenced-based intervention designed to help clients explore and resolve ambivalence around substance use.,"[{'ForeName': 'Margo C', 'Initials': 'MC', 'LastName': 'Villarosa-Hurlocker', 'Affiliation': 'Center on Alcoholism, Substance Abuse, & Addictions, 2650 Yale Blvd SE, Albuquerque, NM 87106, USA; University of New Mexico, Logan Hall MSC03-2220, 1 University of New Mexico, Albuquerque, NM 87131, USA. Electronic address: mhurlocker@unm.edu.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': ""O'Sickey"", 'Affiliation': 'Center on Alcoholism, Substance Abuse, & Addictions, 2650 Yale Blvd SE, Albuquerque, NM 87106, USA; University of New Mexico, Logan Hall MSC03-2220, 1 University of New Mexico, Albuquerque, NM 87131, USA. Electronic address: aosickey@unm.edu.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Houck', 'Affiliation': 'Center on Alcoholism, Substance Abuse, & Addictions, 2650 Yale Blvd SE, Albuquerque, NM 87106, USA; University of New Mexico, Logan Hall MSC03-2220, 1 University of New Mexico, Albuquerque, NM 87131, USA. Electronic address: jhouck@unm.edu.'}, {'ForeName': 'Theresa B', 'Initials': 'TB', 'LastName': 'Moyers', 'Affiliation': 'Center on Alcoholism, Substance Abuse, & Addictions, 2650 Yale Blvd SE, Albuquerque, NM 87106, USA; University of New Mexico, Logan Hall MSC03-2220, 1 University of New Mexico, Albuquerque, NM 87131, USA. Electronic address: tmoyers@unm.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.10.001']
1868,31201564,Cobb angle measurement with a conventional convex echography probe and a smartphone.,"BACKGROUND CONTEXT


Serial X-rays are needed during the follow-up of adolescent idiopathic scoliosis. They are done every 6 or 3 months in cases of high risk of progression. Thanks to the advances in ultrasound techniques, deformity measurement systems free from ionizing radiations have been validated, although spinal surgeons did not use them routinely due to the need of special software.
OBJECTIVE


The aim of our work is to assess the reproducibility and correlation of an ultrasound measuring system based on the positioning of the transverse processes.
STUDY DESIGN


Prospective, single center, randomized, triple blinded.
METHODS


Two independent researchers trained in ultrasound examined the spinal deformities of 31 children. The measurements were compared against those performed with an X-ray by three scoliosis expert surgeons. Statistics were performed by an independent researcher. Parametric methods were used.
RESULTS


We found a 95% [(0.91-0.97) p < 2.2e -16 ] correlation between the degree of scoliosis measured with the proposed ultrasound system and the 30 cm × 90 cm X-rays in standing position. There was an intra-observer reliability of 97% [r-squared = 0.97; CI 95% (0.95-0.98) p < 2.2e -16 ] and an inter-observer reliability of 95% [r-squared = 0.95; CI 95% (0.90-0.97) p < 2.2e -16 ].
CONCLUSIONS


An approximation of the Cobb angle measure is possible with ultrasound by using the transverse processes as reference. This is a very rapid and simple system for assessing the principal spinal deformity measure in young people, although it does not allow estimating the associated axial or sagittal rotation. These slides can be retrieved under Electronic Supplementary Material.",2019,We found a 95% [(0.91-0.97) p < 2.2e -16 ] correlation between the degree of scoliosis measured with the proposed ultrasound system and the 30 cm × 90 cm X-rays in standing position.,"['young people', 'Two independent researchers trained in ultrasound examined the spinal deformities of 31 children']",['conventional convex echography probe and a smartphone'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]",[],31.0,0.044673,We found a 95% [(0.91-0.97) p < 2.2e -16 ] correlation between the degree of scoliosis measured with the proposed ultrasound system and the 30 cm × 90 cm X-rays in standing position.,"[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Ferràs-Tarragó', 'Affiliation': 'La Fe Hospital, Valencia, Spain. cotferras@gmail.com.'}, {'ForeName': 'J M Morales', 'Initials': 'JMM', 'LastName': 'Valencia', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'P Rubio', 'Initials': 'PR', 'LastName': 'Belmar', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'S Pérez', 'Initials': 'SP', 'LastName': 'Vergara', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'P Jordà', 'Initials': 'PJ', 'LastName': 'Gómez', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'J L Bas', 'Initials': 'JLB', 'LastName': 'Hermida', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'P Bas', 'Initials': 'PB', 'LastName': 'Hermida', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'T Bas', 'Initials': 'TB', 'LastName': 'Hermida', 'Affiliation': 'La Fe Hospital, Valencia, Spain.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06030-0']
1869,31388914,Family Caregiver Skills Training to Improve Experiences of Care: a Randomized Clinical Trial.,"OBJECTIVE


To evaluate the effectiveness of Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES), a skills training program for caregivers of persons with functional or cognitive impairments.
DESIGN


A two-arm RCT.
SETTING


Single Veterans Affairs Medical Center.
PARTICIPANTS


Patients and their primary caregivers referred in the past 6 months to home and community-based services or geriatrics clinic.
INTERVENTION


All caregivers received usual care. Caregivers in HI-FIVES also received five training calls and four group training sessions.
MAIN MEASURES


Cumulative patient days at home 12 months post-randomization, defined as days not in an emergency department, inpatient hospital, or post-acute facility. Secondary outcomes included patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms.
RESULTS


Of 241 dyads, caregivers' (patients') mean age was 61 (73) years, 54% (53%) Black and 89% (4%) female. HI-FIVES was associated with a not statistically significant 9% increase in the rate of days at home (95% CI 0.72, 1.65; mean difference 1 day over 12 months). No significant differences were observed in health care costs or caregiver depressive symptoms. Model-estimated mean baseline patient experience of VA care (scale of 0-10) was 8.43 (95% CI 8.16, 8.70); the modeled mean difference between HI-FIVES and controls at 3 months was 0.29 (p = .27), 0.31 (p = 0.26) at 6 months, and 0.48 (p = 0.03) at 12 months. For caregivers, it was 8.34 (95% CI 8.10, 8.57); the modeled mean difference at 3 months was 0.28 (p = .18), 0.53 (p < .01) at 6 months, and 0.46 (p = 0.054) at 12 months.
CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points. The training holds promise in increasing an important metric of care quality-reported experience with care.",2019,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","['Patients and their primary caregivers referred in the past 6\xa0months to home and community-based services or geriatrics clinic', 'caregivers of persons with functional or cognitive impairments', 'Single Veterans Affairs Medical Center', 'mean age was 61 (73) years, 54% (53', ""Of 241 dyads, caregivers' (patients""]","['Family Caregiver Skills Training', 'usual care', 'skills training program']","['emergency department, inpatient hospital, or post-acute facility', 'HI', 'rate of days at home', ""patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms"", 'health care costs or caregiver depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",241.0,0.133213,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","[{'ForeName': 'Courtney Harold', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA. courtney.vanhoutven@duke.edu.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lindquist', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chapman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': 'School of Nursing, Duke University Medical Center, 307 Trent Drive, Box 102400, Durham, NC, 27710, USA.'}, {'ForeName': 'Susan Nicole', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'King', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Shepherd-Banigan', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1101A McGavran-Greenberg Hall, Campus Box 7411, Chapel Hill, NC, 27599, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05209-x']
1870,31822377,Feasibility of a self-management intervention in adolescents with headache (SMI-AH).,"PURPOSE


This study assessed the acceptability and limited efficacy of a self-management intervention to improve lifestyle behaviors and headache outcomes among rural adolescents with recurrent headache.
DESIGN AND METHODS


Participants were randomly assigned to a self-management intervention for adolescent headache (SMI-AH, n = 13) or standard care group (n = 17). The SMI-AH group participated in goal-setting, self-monitoring, and information processing to modify lifestyle behaviors (missed meals, caffeine intake, and poor sleep). Independent samples t-test was used to compare the means of outcomes at baseline and 6-week follow-up between the treatment group and control group. Linear mixed model (LMM) was used to examine the intervention effects over time.
RESULTS


The mean age was 14.8 years (sd = 1.6, range, 12-17); with female participants accounting for 80% of the sample (n = 24) and persons reporting white race were 97% (n = 29). The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch. The multivariate LMM showed significant intervention effect of lunch intake (p = 0.042 with Cohen's d = 0.42) and borderline significant effect of breakfast intake (p = 0.064 with Cohen's d = 0.38). Participants reported the intervention was easy to use and helpful to monitor behaviors.
CONCLUSIONS


Among rural adolescents, a self-management intervention is a feasible approach for engaging youth. The SMI-AH provides an opportunity for the adolescents to talk about their behaviors and participate in goal setting as well as the plan of care with the provider. Challenges identified in this study are manageable and a full study is feasible with modifications.",2020,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","['adolescents with headache (SMI-AH', 'Participants', 'rural adolescents with recurrent headache', 'The mean age was 14.8\xa0years (sd\xa0=\xa01.6, range, 12-17); with female participants accounting for 80% of the sample (n\xa0=\xa024) and persons reporting white race were 97% ', 'rural adolescents']","['self-management intervention for adolescent headache (SMI-AH, n\xa0=\xa013) or standard care group', 'self-management intervention']","['lifestyle behaviors and headache outcomes', 'lunch intake', 'days of eating breakfast and lunch', 'lifestyle behaviors', 'breakfast intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0239888', 'cui_str': 'Headache recurrent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]",,0.0316817,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","[{'ForeName': 'Suzy Mascaro', 'Initials': 'SM', 'LastName': 'Walter', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: swalters@hsc.wvu.edu.'}, {'ForeName': 'R David', 'Initials': 'RD', 'LastName': 'Parker', 'Affiliation': 'Adelphi University College of Nursing and Public Health, Garden City, NY 11530, United States of America. Electronic address: rdparker@adelphi.edu.'}, {'ForeName': 'Kesheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: kesheng.wang@hsc.wvu.edu.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: Zheng.Dai@hsc.wvu.edu.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Starcher', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: mrstarcher@hsc.wvu.edu.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151223']
1871,31352511,Effects of a multimodal analgesic pathway with transversus abdominis plane block for lumbar spine fusion: a prospective feasibility trial.,"PURPOSE


Lumbar spine fusion with anterior (ALIF) or lateral (LLIF) approach is a moderately painful procedure associated with significant length of hospital stay (LoS) and opioid requirements. We developed an opioid-sparing analgesic pathway of care for ALIF and LLIF, featuring transversus abdominis plane (TAP) block. In this study, we assessed the feasibility of performing the TAP block as an analgesic adjunct for ALIF or LLIF.
METHODS


This is a prospective feasibility study of 32 patients. All patients received pre-incisional TAP block, regularly scheduled non-opioid analgesics (gabapentin, acetaminophen, ketorolac), and oral tramadol, as needed. The primary feasibility outcomes were rates of recruitment, adherence and adverse events associated with the TAP block. Secondary outcomes included assessment of TAP block efficacy and duration, numeric rating scale (NRS) pain scores, LoS and opioid consumption.
RESULTS


Thirty-three patients were approached for the study, and all were enrolled. One patient did not have surgery. All patients received the intervention. There were no block-related adverse events. PACU NRS scores were significantly lower (1.9 ± 3.0) than at postoperative day 1 (POD1; 3.3 ± 2.5). The TAP block was effective in 31/32 patients, with 1 failed block. Median LoS was 26.8 h (IQR 22.8-49.5 h). Median opioid consumption was 57.5 oral morphine equivalents (IQR 30-74.38). One patient required opioid iv patient-controlled analgesia.
CONCLUSIONS


Applying TAP block to spine surgery is a novel pain management strategy. This study demonstrates high patient acceptance and the general safety of the technique. Although lacking a control arm, these results also provide preliminary data supporting efficacy. These slides can be retrieved under Electronic Supplementary Material.",2019,There were no block-related adverse events.,"['Thirty-three patients were approached for the study, and all were enrolled', '32 patients', 'lumbar spine fusion']","['multimodal analgesic pathway with transversus abdominis plane block', 'Lumbar spine fusion with anterior (ALIF) or lateral (LLIF) approach', 'TAP block', 'pre-incisional TAP block, regularly scheduled non-opioid analgesics (gabapentin, acetaminophen, ketorolac), and oral tramadol']","['PACU NRS scores', 'block-related adverse events', 'Median opioid consumption', 'assessment of TAP block efficacy and duration, numeric rating scale (NRS) pain scores, LoS and opioid consumption', 'rates of recruitment, adherence and adverse events associated with the TAP block', 'Median LoS']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]",33.0,0.0523676,There were no block-related adverse events.,"[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Soffin', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 1002, USA. soffine@hss.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Freeman', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 1002, USA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Hughes', 'Affiliation': 'Department of Orthopedic Surgery, Spine Care Institute, Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Wetmore', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 1002, USA.'}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 1002, USA.'}, {'ForeName': 'Federico P', 'Initials': 'FP', 'LastName': 'Girardi', 'Affiliation': 'Department of Orthopedic Surgery, Spine Care Institute, Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'Haoyan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Healthcare Research Institute, Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Beckman', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 1002, USA.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06081-3']
1872,31471739,Narrow-band imaging assisted cystoscopy in the follow-up of patients with transitional cell carcinoma of the bladder: a randomized study in comparison with white light cystoscopy.,"PURPOSE


To evaluate the diagnostic accuracy of a second look narrow-band imaging (NBI) cystoscopy in the follow-up of patients with NMIBC as compared to a second white light cystoscopy (WLI).
PATIENTS AND METHODS


From August 2013 to October 2014, 600 patients with history of non-muscle invasive bladder cancer (NMIBC), who presented for follow-up cystoscopy at an academic outpatient clinic, were randomized to flexible WLI-cystoscopy plus second look NBI-cystoscopy (n = 300) or flexible WLI-cystoscopy plus second look WLI-cystoscopy (n = 300) in the same session. We analysed the detection rate of bladder tumours in second look cystoscopy as primary endpoint. In addition, we evaluated recurrence rates before study enrolment and after transurethral resection (TUR-BT) in each group.
RESULTS


In 600 patients with a history of NMIBC, 78 out of 300 patients (26%) with WLI-NBI-cystoscopy and 70 out of 300 patients (23%) with WLI-WLI-cystoscopy were diagnosed with cancer recurrence (p = 0.507). Overall, WLI-NBI detected 404 and WLI-WLI 234 lesions, respectively. The second look cystoscopy detected 57 additional cancer lesions: 45 tumours in 18 patients with WLI-NBI and 12 tumours in 9 patients with WLI-WLI (p = 0.035). After initial examination without tumour detection an improvement was determined by the second cystoscopy in 3 patients (75 vs. 78 pat.) with WLI-NBI and in only one patient (69 vs. 70 pat.) with WLI-WLI (p = 0.137). Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120). After TUR-BT the median recurrence-free survival was 4 months in 57 recurring patients (73%) in the group with WLI-NBI- and 6 months in 56 patients (80%) with WLI-WLI-cystoscopy (p = 0.373), respectively.
CONCLUSION


Our study showed no differences in per-patient tumour detection between WLI and NBI. Although NBI has significant benefits for detecting individual lesions overlooked by WLI-cystoscopy, this did not positively affect recurrence-free survival after transurethral resection.",2020,Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120).,"['600 patients with a history of NMIBC, 78 out of 300 patients', '18 patients with WLI-NBI and 12 tumours in 9 patients with WLI-WLI (p\u2009=\u20090.035', 'patients with transitional cell carcinoma of the bladder', 'patients with NMIBC as compared to a second white light cystoscopy (WLI', 'From August 2013 to October 2014, 600 patients with history of non-muscle invasive bladder cancer (NMIBC), who presented for follow-up cystoscopy at an academic outpatient clinic']","['transurethral resection (TUR-BT', 'Narrow-band imaging assisted cystoscopy', 'white light cystoscopy', 'flexible WLI-cystoscopy plus second look NBI-cystoscopy (n\u2009=\u2009300) or flexible WLI-cystoscopy plus second look WLI-cystoscopy', 'second look narrow-band imaging (NBI) cystoscopy']","['median recurrence-free survival', 'cancer recurrence', 'detection rate of bladder tumours', 'recurrence-free survival', 'detection of carcinoma', 'recurrence rates']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4517405', 'cui_str': '0.035'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]",600.0,0.0533585,Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tschirdewahn', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Harke', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hirner', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stagge', 'Affiliation': 'Outpatient Clinic Praxisklinik für Urologie Rhein/Ruhr, Schulstr. 11, 45468, Mülheim an der Ruhr, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenhardt', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany. a.eisenhardt@pur-r.de.'}]",World journal of urology,['10.1007/s00345-019-02926-0']
1873,31552872,"Addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% increasing the duration of postoperative analgesia in the lower abdominal pain surgery among children: A double-blinded randomized clinical study.","Pain is a common complication after surgery. Insufficient control of postoperative pain has adverse effects on the physiological, metabolic and psychological state of the child. The use of local analgesics and anesthetics alone cannot produce complete anesthesia and intraoperative comfort. The addition of adjuvant drugs is commonly used to improve the quality of the block. Therefore, adding new supplements may increase the duration of analgesia. The aim of this study was to compare the addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% in increasing the duration of postoperative analgesia in the lower abdominal pain surgery in children aged 2-8 years. This double-blind randomized clinical trial was conducted on children candidate for lower abdominal surgery. The 96 patients were randomly divided into 3 groups including dexmedetomidine, neostigmine, and tramadol. For all children, 3 mg of midazolam was administered orally before entering the operating room. The patients underwent general anesthesia with 2 μg/kg fentanyl, 0.03 mg/kg midazolam, 0.5 mg/kg atracurium and 5-6 mg/kg thiopental. After determining the hiatus membrane, 2 mL syringes containing air and distilled water (each of which 1 mL) slowly entered the space. After eliminating caudal resistance, 1.5% lidocaine was injected at dose of 0.5 mL/kg. A total of 96 patients were enrolled in this study. The results revealed that pain scores in the dexmedetomidine group in recovery, 2, 6 and 12 hours after surgery were less than the other two groups. Furthermore, the tramadol group showed a lower score in comparison with the neostigmine group and the duration of analgesia in the dexmedetomidine group was more than the other two groups. In addition, the mean of analgesic at 24 hours after operation in the dexmedetomidine group was lower as compared to the other two groups, indicating the effect of dexmedetomidine as an adjuvant in increasing the duration of analgesia and reducing postoperative pain in patients along with lidocaine 1.5%. All three drugs (neostigmine, tramadol and dexmedetomidine drugs), along with other local anesthetic, increased the duration of analgesia and decreased postoperative pain in children. The effect of dexmedetomidine was greater than the other two drugs. The study was approved by the Ethics Committee of Arak University of Medical Sciences, Iran (approved No. IR.ARAKMU.REC.1396.112) on October 28, 2017, and registered at Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N83) on August 29, 2018.",2019,"Furthermore, the tramadol group showed a lower score in comparison with the neostigmine group and the duration of analgesia in the dexmedetomidine group was more than the other two groups.","['96 patients', 'Arak University of Medical Sciences, Iran (approved No. IR.ARAKMU.REC.1396.112) on October 28, 2017, and registered at Iranian Registry of Clinical Trials (registration No', '96 patients were enrolled in this study', 'children aged 2-8 years', 'children', 'lower abdominal pain surgery among children', 'children candidate for lower abdominal surgery']","['tramadol', 'midazolam', 'dexmedetomidine', 'lidocaine', 'general anesthesia with 2 μg/kg fentanyl, 0.03 mg/kg midazolam, 0.5 mg/kg atracurium and 5-6 mg/kg thiopental', 'dexmedetomidine, tramadol and neostigmine', 'dexmedetomidine, neostigmine, and tramadol', 'neostigmine', 'neostigmine, tramadol and dexmedetomidine']","['pain scores', 'duration of postoperative analgesia', 'duration of analgesia and decreased postoperative pain', 'mean of analgesic', 'duration of analgesia', 'duration of analgesia and reducing postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232495', 'cui_str': 'Lower abdominal pain (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",96.0,0.192304,"Furthermore, the tramadol group showed a lower score in comparison with the neostigmine group and the duration of analgesia in the dexmedetomidine group was more than the other two groups.","[{'ForeName': 'Tara Hasani', 'Initials': 'TH', 'LastName': 'Goudarzi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Yazdi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Gholamreza Nouri', 'Initials': 'GN', 'LastName': 'Broujerdi', 'Affiliation': 'Department of Surgery, Arak University of Medical Sciences, Arak, Iran.'}]",Medical gas research,['10.4103/2045-9912.266984']
1874,31469675,Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification in Primary Angle-closure Glaucoma: A Randomized Controlled Study.,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates. Although releasable sutures may have reduced the risk of hypotony; complications and interventions were more common with phacotrabeculectomy.
PURPOSE


To compare the efficacy and safety of phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone in the management of PACG.
PATIENTS AND METHODS


In total, 63 eyes of 63 PACG patients were randomized to undergo either mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone. The primary outcomes were success rates and complications. Secondary outcomes were IOP and glaucoma medications.
RESULTS


The IOP and glaucoma medications were significantly reduced at 1, 3, 6, and 12 months postoperatively in both groups (P<0.001). There was no statistically significant difference in IOP, IOP reduction, success rates, or survival times between both groups. Glaucoma medications were only significantly lower in the phacotrabeculectomy group at 1 and 3 months. The rates of postoperative interventions and complications were higher in the phacotrabeculectomy group. Complete success, defined as an IOP of 6 to 21 mm Hg on no medications and with no signs of glaucoma progression, was achieved in 58% in the phacotrabeculectomy group, compared with 62% in the phacoemulsification group (P=0.9). Only 2 eyes (6%) in the phacoemulsification group required a subsequent trabeculectomy.
CONCLUSIONS


Trabeculectomy did not seem to add an advantage when combined with phacoemulsification in PACG patients and was associated with more postoperative interventions. Despite the use of releasable sutures to allow titration of the IOP postoperatively, the rate of hypotony and other complications was higher in the phacotrabeculectomy group.",2019,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","['Primary Angle-closure Glaucoma', 'In total, 63 eyes of 63 PACG patients']","['phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone', 'Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification', 'mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone']","['rates of postoperative interventions and complications', 'Complete success', 'intraocular pressure (IOP) lowering, glaucoma medications and success rates', 'Glaucoma medications', 'rate of hypotony and other complications', 'success rates and complications', 'IOP, IOP reduction, success rates, or survival times', 'efficacy and safety', 'glaucoma progression', 'IOP and glaucoma medications']","[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.14059,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'El Sayed', 'Affiliation': 'Department of Ophthalmology, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': ''}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Albalkini', 'Affiliation': ''}, {'ForeName': 'Reem H', 'Initials': 'RH', 'LastName': 'El Sheikh', 'Affiliation': ''}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Osman', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001345']
1875,32439849,Effects of caffeine intake and exercise intensity on executive and arousal vigilance.,"During physical efforts and sport practice, vigilance is responsible for maintaining an optimal state of activation, guaranteeing the ability to quickly respond and detect unexpected, but critical, stimuli over time. Caffeine and physical exercise are able to modulate the activation state, affecting vigilance performance. The aim of the present work was to assess the specific effects and modulations of caffeine intake and two physical intensities on vigilance components. Participants performed an attentional task (ANTI-Vea) to measure the executive and arousal components of vigilance, in six double-blinded counterbalanced sessions combining caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise. Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates. Instead, caffeine intake generally improved arousal vigilance. In conclusion, caffeine and acute exercise seems to moderate executive and arousal vigilance in different ways.",2020,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.",[],"['Caffeine and physical exercise', 'caffeine', 'attentional task (ANTI-Vea', 'caffeine and acute exercise', 'caffeine intake and exercise intensity', 'caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise']","['arousal vigilance', 'moderate executive and arousal vigilance', 'executive and arousal vigilance', 'executive vigilance with faster overall reaction time (RT), without impairing error rates']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0355207,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain. carlos.sanchis@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain. jlupiane@ugr.es.'}]",Scientific reports,['10.1038/s41598-020-65197-5']
1876,32439603,The effects of imaginary eating on visual food cue reactivity: An event-related potential study.,"Previous research has demonstrated that imagining consumption of a specific type of food helps individuals to consume less of that food. The present event-related potential study aimed at investigating the underlying neural correlates of this appetite-reducing strategy. A total of 86 women (mean age = 23.65 years) were randomly assigned to one of three imagination conditions. In each condition, they listened to a guided imagery script that either described the eating of 30 colorful button-shaped chocolates (M&Ms), the sorting of 30 M&Ms by color, or the sorting of 30 marbles by color. Subsequently to the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram and craving ratings were recorded. The results showed that imaginary eating did not reduce the appetitive value of M&M pictures. The M&M sorting group reported enhanced craving and showed increased late positivity toward M&M pictures (300-600 ms after picture onset) compared to the two other groups. The present findings indicate that the imagined handling of food increases food cue reactivity and that imaginary eating is not a reliable method to reduce appetite.",2020,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,['86 women (mean age\u202f=\u202f23.65 years'],['imaginary eating'],"['enhanced craving', 'appetitive value of M&M pictures', 'visual food cue reactivity', 'electroencephalogram and craving ratings', 'late positivity toward M&M pictures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",86.0,0.0227251,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,"[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Appetite,['10.1016/j.appet.2020.104743']
1877,32439860,A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis.,"Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.",2020,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","['children younger than 5 years annually', '816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens', 'children with acute gastroenteritis']","['combination probiotic', 'probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],816.0,0.233591,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Pang', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chui', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': 'University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, UCA 45229, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Sherman', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Bonita E', 'Initials': 'BE', 'LastName': 'Lee', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Farion', 'Affiliation': 'University of Ottawa, 401 Smyth Rd, Ottawa, ON, K1H 8L1, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'University of Western Ontario, 800 Commissioners Road E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Hurley', 'Affiliation': 'Dalhousie University, 5980 University Avenue, PO Box 9700, Halifax, NS, B3K 6R8, Canada.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Binal', 'Initials': 'B', 'LastName': 'Ghandi', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16308-3']
1878,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
1879,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1']
1880,30622105,Transcriptomic Profiling of the Tumor Microenvironment Reveals Distinct Subgroups of Clear Cell Renal Cell Cancer: Data from a Randomized Phase III Trial.,"Metastasis remains the main reason for renal cell carcinoma (RCC)-associated mortality. Tyrosine kinase inhibitors (TKI) impart clinical benefit for most patients with RCC, but the determinants of response are poorly understood. We report an integrated genomic and transcriptomic analysis of patients with metastatic clear cell RCC (ccRCC) treated with TKI therapy and identify predictors of response. Patients in the COMPARZ phase III trial received first-line sunitinib or pazopanib with comparable efficacy. RNA-based analyses revealed four distinct molecular subgroups associated with response and survival. Characterization of these subgroups identified mutation profiles, angiogenesis, and macrophage infiltration programs to be powerful predictors of outcome with TKI therapy. Notably, predictors differed by the type of TKI received. Our study emphasizes the clinical significance of angiogenesis and immune tumor microenvironment and suggests that the critical effects its various aspects have on TKI efficacy vary by agent. This has broad implications for optimizing precision treatment of RCC. SIGNIFICANCE: The determinants of response to TKI therapy in metastatic ccRCC remain unknown. Our study demonstrates that key angiogenic and immune profiles of the tumor microenvironment may affect TKI response. These findings have the potential to inform treatment personalization in patients with RCC. This article is highlighted in the In This Issue feature, p. 453 .",2019,"Characterization of these subgroups identified mutation profiles, angiogenesis, and macrophage infiltration programs to be powerful predictors of outcome with TKI therapy.","['patients with metastatic clear cell RCC (ccRCC) treated with', 'patients with RCC']","['Tyrosine kinase inhibitors (TKI', 'first-line sunitinib or pazopanib', 'TKI therapy']","['TKI response', 'response and survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",,0.017976,"Characterization of these subgroups identified mutation profiles, angiogenesis, and macrophage infiltration programs to be powerful predictors of outcome with TKI therapy.","[{'ForeName': 'A Ari', 'Initials': 'AA', 'LastName': 'Hakimi', 'Affiliation': 'Department of Urology, Memorial Sloan Kettering Cancer Center, New York, New York. hakimia@mskcc.org vossm@mskcc.org chant@mskcc.org.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. hakimia@mskcc.org vossm@mskcc.org chant@mskcc.org.'}, {'ForeName': 'Fengshen', 'Initials': 'F', 'LastName': 'Kuo', 'Affiliation': 'Immunogenomics and Precision Oncology Platform, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Sanchez', 'Affiliation': 'Department of Urology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Immunology Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Briana G', 'Initials': 'BG', 'LastName': 'Nixon', 'Affiliation': 'Immunology Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Vuong', 'Affiliation': 'Immunogenomics and Precision Oncology Platform, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Ostrovnaya', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ying-Bei', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Reuter', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Riaz', 'Affiliation': 'Immunogenomics and Precision Oncology Platform, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Oncology, New York, New York.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Novartis Oncology, New York, New York.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Oncology, New York, New York.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Reising', 'Affiliation': 'Novartis Oncology, New York, New York.'}, {'ForeName': 'Ming O', 'Initials': 'MO', 'LastName': 'Li', 'Affiliation': 'Immunology Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Chan', 'Affiliation': 'Immunogenomics and Precision Oncology Platform, Memorial Sloan Kettering Cancer Center, New York, New York. hakimia@mskcc.org vossm@mskcc.org chant@mskcc.org.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer discovery,['10.1158/2159-8290.CD-18-0957']
1881,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z']
1882,32440048,Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children.,"Background


Children with high level of preoperative anxiety during their visit to dental office are more likely to develop maladaptive behavior postoperatively. First dental experience is always critical in molding child's attitude toward dentistry. Various behavior management methods are being employed during dental treatment to complete anticipated treatment in children.
Aim


The aim of the study was to evaluate the effectiveness of cognitive behavioral play therapy and audiovisual distraction for management of preoperative anxiety in children.
Materials and methods


A total of 45 children of age 6-10 years with moderate-to-severe anxiety were allocated into three groups: group I-cognitive behavioral play therapy (CBT), group II-audiovisual (AV) distraction, and group III-tell-show-do technique (control group). Children in the CBT group were allowed to play with building blocks, asked to draw a picture and then showed a modeling video of co-operative child undergoing dental treatment. Children in group II were subjected to passive distraction with audiovisual aids, whereas group III (control) children were managed with the conventional TSD technique. Baseline and postintervention objective and subjective anxiety scores were measured with a pulse oximeter and facial image scale (FIS), respectively.
Results


A statistically significant reduction in the subjective and objective anxiety scores is observed in all the three groups ( p  = 0.001) in both intragroup and intergroup comparisons. On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
Conclusion


Active distraction with cognitive behavioral play therapy is found to be more effective in reducing the preoperative anxiety in children compared to audiovisual distraction and tell-show-do technique.
Clinical significance


Identification and management of preoperative anxiety in children is most critical for successful dental treatment. Active distraction is an effective psychological approach for behavior management in anxious children.
How to cite this article


Rajeswari SR, Chandrasekhar R, Vinay C,  et al.  Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent 2019;12(5):419-422.",2019,"On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
","['45 children of age 6-10 years with moderate-to-severe anxiety', 'Children', 'anxious children', 'children']","['conventional TSD technique', 'cognitive behavioral play therapy (CBT), group II-audiovisual (AV) distraction, and group III-tell-show-do technique (control group', 'cognitive behavioral play therapy and audiovisual distraction', 'cognitive behavioral play therapy', 'Cognitive Behavioral Play Therapy and Audiovisual Distraction', 'Active distraction', 'passive distraction with audiovisual aids']","['subjective and objective anxiety scores', 'Baseline and postintervention objective and subjective anxiety scores', 'preoperative anxiety', 'reduction in subjective and objective anxiety scores', 'pulse oximeter and facial image scale (FIS), respectively']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039373', 'cui_str': 'Tay-Sachs disease'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004282', 'cui_str': 'Audio-Visual Aids'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0196022,"On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
","[{'ForeName': 'Sandaka Raja', 'Initials': 'SR', 'LastName': 'Rajeswari', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Rayala', 'Initials': 'R', 'LastName': 'Chandrasekhar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vinay', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Uloopi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Kakarla Sri', 'Initials': 'KS', 'LastName': 'RojaRamya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Manumanthu Venkata', 'Initials': 'MV', 'LastName': 'Ramesh', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1661']
1883,32440039,"Comparative Analysis of CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite on Assessment of Dentinal Tubule Occlusion on Primary Enamel Using SEM: An  In Vitro  Study.","Background


Over the last few decades, fluoride in various forms has been proved to reduce caries and dentinal hypersensitivity in both the primary and permanent dentitions. Recently, newer materials containing calcium and phosphate ions, tricalcium phosphate, and hydroxyapatite has received much attention.
Aim


The aim of the study was to compare CPP-ACP, tricalcium phosphate, and hydroxyapatite in relation to the assessment of dentine tubule occlusion on primary enamel using scanning electron microscope (SEM).
Materials and methods


Forty freshly extracted noncarious primary molars were randomly divided into 4 groups (I-IV) with 10 sections in each group-group I: negative control, group II: CPP-ACP, group III: tricalcium phosphate, group IV: hydroxyapatite. To assess tubule occlusion, twenty dentin sections of 2-mm thickness were obtained from the cervical third of sound primary molars. Each section was processed to simulate the hypersensitive dentin and the test agents were brushed over the sections with an electric toothbrush and observed under a SEM for calculation of the percentage of occluded tubules.
Results


Groups II and IV showed a greater percentage of tubule occlusion than group III. An intergroup comparison of tubule occlusion potential of groups II and IV was not significant.
Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
How to cite this article


Shah R, Bajaj M. Comparative Analysis of CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite on Assessment of Dentinal Tubule Occlusion on Primary Enamel Using SEM: An  In Vitro  Study. Int J Clin Pediatr Dent 2019;12(5):371-374.",2019,"Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
","['Materials and methods\n\n\nForty freshly extracted noncarious primary molars', 'Primary Enamel Using SEM']","['CPP-ACP, group III: tricalcium phosphate, group IV: hydroxyapatite', 'CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite', 'Hydroxyapatite']","['percentage of tubule occlusion', 'dentinal tubule occlusion', 'caries and dentinal hypersensitivity']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",40.0,0.0141091,"Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
","[{'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Bharti Vidyapeeth Deemed University, Dental College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Bajaj', 'Affiliation': 'Private Practice, Meghna Dental Care, Navi Mumbai, Maharashtra, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1680']
1884,32440042,Plaque Removal Efficacy of Different Toothbrushes: A Comparative Study.,"Aim and objective


This study aimed to compare the plaque removal efficacy of different toothbrushes and to ascertain the most efficient mechanical mean for daily plaque removal so as to maintain oral health in a preeminent way.
Study design


It was a randomized controlled clinical trial consisting of 60 subjects divided into three groups (group I ultrasonic and sonic toothbrush, group II multidirectional toothbrush, and group III manual toothbrush) with 20 in each group. Prebrushing and postbrushing plaque scores were recorded at weekly intervals for four weeks using Turesky modification of Quigley and Hein plaque index.
Results


Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77). Similar results were found in post-day 1 to post-day 28 mean percent reduction in plaque values.
Conclusion


Group II (i.e., multidirectional toothbrush) showed maximum mean percent reduction in prebrushing and postbrushing plaque scores at the end of four weeks when compared with the baseline values followed by ultrasonic toothbrush and manual toothbrush.
How to cite this article


Aggarwal N, Gupta S, Grover R,  et al.  Plaque Removal Efficacy of Different Toothbrushes: A Comparative Study. Int J Clin Pediatr Dent 2019;12(5):385-390.",2019,"Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77).",['60 subjects divided into three groups (group I'],"['ultrasonic and sonic toothbrush, group II multidirectional toothbrush, and group III manual toothbrush', 'Different Toothbrushes']","['Plaque Removal Efficacy', 'plaque values', 'maximum mean percent reduction in prebrushing and postbrushing plaque scores', 'Prebrushing and postbrushing plaque scores']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0291,"Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77).","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Rashu', 'Initials': 'R', 'LastName': 'Grover', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Gunmeen', 'Initials': 'G', 'LastName': 'Sadana', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Bansal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Adesh Institute of Dental Sciences and Research, Bathinda, Punjab, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1669']
1885,32440060,Nanosilver Fluoride-A Paradigm Shift for Arrest in Dental Caries in Primary Teeth of Schoolchildren: A Randomized Controlled Clinical Trial.,"Background


Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries. Arresting caries treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities.
Aims and objectives


The purpose of the present controlled clinical trial is to investigate the effectiveness of a new anticaries agent, nanosilver fluoride (NSF), preventing and arresting caries in children.
Materials and methods


A total of 100 deciduous molars both maxillary and mandibular are randomly selected from 60 children of 4-9 years of age group, which were randomly divided into NSF experimental group and saline control group. Teeth were clinically diagnosed and treated by one masked examiner and followed up at 7 days, 5 months and 12 months by another calibrated examiner who was blinded to the type of treatment. The criteria of the ICDAS II were followed to determine the activity of lesion and the diagnosis of caries. The Pearson's Chi-square test was used to compare the groups during different follow-up examinations.
Results


Seventy-eight percent of decayed teeth showed hard arrested dentine at 7 days; after 5-month analysis in the NSF group, 72.91% of the teeth showed arrested caries; and in the control group, only 34% of teeth showed arrest of caries. At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
Conclusion


The present study proves that NSF is an anticaries agent and presents a noninvasive option for caries arrest and treatment when applied directly to dentin caries lesions.
How to cite this article


Nagireddy VR, Reddy D, Kondamadugu S,  et al.  Nanosilver Fluoride-A Paradigm Shift for Arrest in Dental Caries in Primary Teeth of Schoolchildren: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent 2019;12(6):484-490.",2019,"At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
","['children of disadvantaged communities', 'Dental Caries in Primary Teeth of Schoolchildren', '100 deciduous molars both maxillary and mandibular are randomly selected from 60 children of 4-9 years of age group', 'children']","['Nanosilver Fluoride-A Paradigm Shift', 'NSF', 'new anticaries agent, nanosilver fluoride (NSF', 'NSF experimental group and saline control group']","['arrest of caries', 'arrested caries']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0772313', 'cui_str': 'colloidal silver'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0266848', 'cui_str': 'Arrested dental caries'}]",,0.0528208,"At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
","[{'ForeName': 'Venugopal R', 'Initials': 'VR', 'LastName': 'Nagireddy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Daneswari', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Saigeeta', 'Initials': 'S', 'LastName': 'Kondamadugu', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Niharika', 'Initials': 'N', 'LastName': 'Puppala', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Ajayreddy', 'Initials': 'A', 'LastName': 'Mareddy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Chris', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1703']
1886,32440066,"Effect of Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses on Oral Health Status of Children: A Randomized Controlled Trial.","Aim


To evaluate the antibacterial effect of herbal water, ozonated water, and chlorhexidine mouthrinses on salivary  Streptococcus mutans  level and to assess their effectiveness of these mouthrinses on the oral health status of children.
Materials and methods


A parallel multiarm randomized controlled trial was conducted in 100 children aged 10-12 years. Debris index-simplified (DI-S), calculus index-simplified (CI-S), oral hygiene index-simplified (OHI-S) scores, and  Streptococcus mutans  counts were recorded at baseline ( T   1 ). They were randomly divided into four equal groups ( n  = 25): HW, herbal water; OW, ozonated water; W, water; and CHX, chlorhexidine. Intervention period was 15 days and data collection was repeated after 15 days ( T   2 ) and 30 days ( T   3 ). Saliva samples were used to evaluate  S. mutans  count. Results were tabulated and analyzed statistically.
Results


OW had minimum DI-S score at  T   2  and  T   3  periods. HW had the minimum CI-S score at  T   2  and  T   3  periods. CHX had the minimum  S. mutans  count at  T   2  and  T   3  periods. OW showed maximum reduction in OHI-S score at  T   2  period. HW showed maximum reduction in OHI-S score at  T   3  period.
Conclusion


Herbal water and ozone water can be used as an alternative to chlorhexidine in maintaining the oral health status.
Clinical significance


Herbal water and ozonated water can be used in children instead of chemical mouthrinses to avoid any adverse effects.
How to cite this article


Mon J, Asokan S, Priya PRG,  et al.  Effect of Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses on Oral Health Status of Children: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2019;12(6):514-519.",2019,"HW showed maximum reduction in OHI-S score at  T   3  period.
","['100 children aged 10-12 years', 'Children', 'Streptococcus mutans', 'children']","['Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses', 'HW, herbal water; OW, ozonated water; W, water; and CHX, chlorhexidine', 'herbal water, ozonated water, and chlorhexidine mouthrinses', 'chlorhexidine']","['minimum DI-S score', 'minimum CI-S score', 'OHI-S score', 'Debris index-simplified (DI-S), calculus index-simplified (CI-S), oral hygiene index-simplified (OHI-S) scores, and']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}]",100.0,0.0605497,"HW showed maximum reduction in OHI-S score at  T   3  period.
","[{'ForeName': 'Jijo', 'Initials': 'J', 'LastName': 'Mon', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Sharath', 'Initials': 'S', 'LastName': 'Asokan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Pollachi Rg', 'Initials': 'PR', 'LastName': 'Priya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Thoppe Dy', 'Initials': 'TD', 'LastName': 'Kumar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Mythili G', 'Initials': 'MG', 'LastName': 'Balasubramaniam', 'Affiliation': 'Department of Biotechnology, KS Rangasamy College of Technology, Tiruchengode, Tamil Nadu, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1693']
1887,32440064,Eye Movement Distraction: A New Distraction Technique for Management of Dental Anxiety during Intraoral Local Anesthesia Administration in Children.,"Background


To evaluate the efficacy of eye movement distraction (EMD) in reducing anxiety during intraoral local anesthetic administration in needle-phobic children.
Materials and methods


A total of 228 children aged 8-13 years were divided into two groups: group I (EMD) and group II (control), and subjective feelings of each child were recorded with a faces pain scale-revised (FPS-R) score. Both the groups (I and II) were compared using the Chi-square test.
Results


Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
Conclusion


Eye movement distraction can be used as an effective distraction modality to reduce anxiety during local anesthesia administration in needle-phobic children.
How to cite this article


Tirupathi S, Krishna N, Rajasekhar S,  et al.  Eye Movement Distraction: A New Distraction Technique for Management of Dental Anxiety during Intraoral Local Anesthesia Administration in Children. Int J Clin Pediatr Dent 2019;12(6):507-509.",2019,"Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
","['228 children aged 8-13 years', 'Children', 'needle-phobic children']","['eye movement distraction (EMD', 'Eye Movement Distraction']","['faces pain scale-revised (FPS-R) score', 'low FPS-R scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",228.0,0.0181991,"Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
","[{'ForeName': 'Sunnypriyatham', 'Initials': 'S', 'LastName': 'Tirupathi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Krishna', 'Affiliation': 'Department of Pedodontics, Narayana Dental College, Nellore, Andhra Pradesh, India.'}, {'ForeName': 'Srinitya', 'Initials': 'S', 'LastName': 'Rajasekhar', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Nuvvula', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1690']
1888,32440093,Inter-Ocular Symmetry of Vascular Density and Retinal Thickness in Unilateral Anisometropic Amblyopia.,"Background


Inter-ocular symmetry of macular vascular anatomy in healthy subjects has been well documented in previous optical coherence tomography angiography (OCTA) studies. In our present study, we have demonstrated that the presence of anisometropic amblyopia in one eye does not alter this unique feature significantly. We investigated whether the presence of unilateral anisometropic amblyopia due to moderate amounts of hyperopia and/or astigmatism would have any significant influence on measurements of retinal thickness (RT) and superficial vessel density (SVD) in adult subjects.
Subjects and methods


In the study group, both eyes of 21 adult subjects with unilateral anisometropic amblyopia were enrolled. Only one eye of an age-matched control group including 33 subjects was randomly selected. RT and SVD were measured in foveal and parafoveal retinal areas and compared in amblyopic eyes, their fellow eyes and in the control group. Inter-ocular symmetry of RT and SVD in amblyopic and fellow eyes were investigated by using correlation analysis.
Results


There were statistically significant inter-ocular correlations of foveal and parafoveal RT in amblyopic and fellow eyes ( P  < 0.0001, for both). Foveal and parafoveal RT of the control group were not statistically different from amblyopic eyes ( P  = 0.072 and  P  = 0.46, respectively). There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
Conclusion


For our adult subjects, none of the investigated OCTA parameters of the amblyopic eyes were found to be statistically different from those of age-matched controls. The preservation of inter-ocular symmetry in the amblyopic and fellow eyes implies that the influence of anisometropic amblyopia in one eye would be relatively small and negligible on routine OCTA examination.",2020,"There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
","['Only one eye of an age-matched control group including 33 subjects was randomly selected', '21 adult subjects with unilateral anisometropic amblyopia were enrolled', 'adult subjects', 'healthy subjects', 'Unilateral Anisometropic Amblyopia', 'Subjects and methods']",['\n\n\nInter-ocular symmetry'],"['retinal thickness (RT) and superficial vessel density (SVD', 'RT and SVD', 'foveal SVD of amblyopic eyes', 'Foveal and parafoveal RT', 'ocular correlations of foveal and parafoveal RT in amblyopic and fellow eyes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",21.0,0.0226238,"There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
","[{'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Pehlivanoglu', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sukru', 'Initials': 'S', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Albayrak', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Muharrem', 'Initials': 'M', 'LastName': 'Karakaya', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S234294']
1889,32440086,Short-Term Efficacy and Safety of Switching from a Latanoprost/Timolol Fixed Combination to a Latanoprost/Carteolol Fixed Combination.,"Purpose


To investigate the short-term intraocular pressure-lowering efficacy and safety of switching from a fixed combination of latanoprost/timolol to a fixed combination of latanoprost/carteolol.
Patients and Methods


The subjects were 30 eyes of 30 adult patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who were using a latanoprost-/timolol-fixed combination with insufficient intraocular pressure-lowering efficacy or adverse reactions. The subjects were switched from once-daily latanoprost/timolol to once-daily latanoprost/carteolol with no washout interval. Intraocular pressure, tear film break-up time, corneal epithelial defects, conjunctival hyperemia, blood pressure, and pulse rate were measured and compared before and 1 and 3 months after switching. Patients were monitored for adverse reactions at each visit, and dropouts were recorded.
Results


The mean intraocular pressure at 1 month (15.9±3.1 mmHg) and 3 months (16.3±3.8 mmHg) was not significantly different from that at baseline (16.1±3.1 mmHg). The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively). There was a significant decrease in systolic blood pressure after 1 month and diastolic pressure after 3 months (p<0.05). There was no significant change in pulse rate during the study. Adverse reactions (blurred vision, blepharitis, and conjunctival hyperemia) occurred in 3 patients (10.0%). Four patients (13.3%) discontinued treatment during the 3-month study period.
Conclusion


A switch from a fixed combination of latanoprost/timolol to that of latanoprost/carteolol can maintain intraocular pressure and adherence with once-daily administration while improving tear film break-up time and corneal epithelial defects.",2020,"The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively).","['subjects were 30 eyes of 30 adult patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who were using a latanoprost-/timolol-fixed combination with insufficient intraocular pressure-lowering efficacy or adverse reactions']","['latanoprost/timolol', 'Latanoprost/Carteolol Fixed Combination', 'Latanoprost/Timolol', 'latanoprost/carteolol']","['mean intraocular pressure', 'Intraocular pressure, tear film break-up time, corneal epithelial defects, conjunctival hyperemia, blood pressure, and pulse rate', 'diastolic pressure', 'pulse rate', 'tear film break-up time and corneal epithelial defects', 'adverse reactions', 'systolic blood pressure', 'intraocular pressure and adherence', 'Adverse reactions (blurred vision, blepharitis, and conjunctival hyperemia']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0152136', 'cui_str': 'Low tension glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]","[{'cui': 'C1271556', 'cui_str': 'Latanoprost- and timolol-containing product'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0007299', 'cui_str': 'Carteolol'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}]",30.0,0.0652169,"The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively).","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Piao', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Iwasa', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Ophthalmology, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Goji', 'Initials': 'G', 'LastName': 'Tomita', 'Affiliation': 'Department of Ophthalmology, Toho University Ohashi Medical Center, Tokyo, Japan.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S240425']
1890,32440098,Pharmacokinetic Evaluation by Modeling and Simulation Analysis of a Donepezil Patch Formulation in Healthy Male Volunteers.,"Introduction


This study characterized the pharmacokinetics (PKs) of a donepezil patch formulation currently under development, using mixed effect modeling analysis, and explored optimal patch dosing regimens in comparison with the donepezil oral formulation.
Methods


PK data used in this analysis were from 60 healthy Korean male subjects participating in two Phase I studies, where subjects received single or multiple doses of donepezil of 43.75, 87.5, and 175 mg via patches, and 12 of them received a single oral dose of 10 mg of donepezil, followed by a single dose of donepezil via a patch. Donepezil PKs were analyzed by nonlinear mixed effect modeling using NONMEM software.
Results


A well-stirred model with two-compartment distribution and delayed absorption was chosen as the best model for the oral formulation. The PKs of donepezil after the patch applications were best described by a two-compartment linear model with zero-order absorption (D2) and absorption delay. The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
Conclusion


PK simulations based on the chosen PK models suggested that, overall, donepezil exposure in plasma is similar whether with 10 mg of oral donepezil every 24 h or a 175 mg patch every 72 h, and likewise with 5 mg of oral donepezil every 24 h or an 87.5 mg patch every 72 h.",2020,"The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
","['Healthy Male Volunteers', '60 healthy Korean male subjects participating in two Phase']","['Donepezil', 'donepezil', 'Donepezil Patch Formulation', 'oral donepezil', 'donepezil patch formulation', 'donepezil oral formulation', 'donepezil via a patch']",['relative bioavailability (BA'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0605022,"The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
","[{'ForeName': 'Seok Kyu', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hyun', 'Initials': 'DH', 'LastName': 'Hong', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Su', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Young Kweon', 'Initials': 'YK', 'LastName': 'Choi', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S244957']
1891,32440068,Comparative Microbiological Evaluation after Caries Removal by Various Burs.,"Aim


The aim of the study was to compare the caries removal efficacy in terms of bacteriology and efficiency in terms of time taken by conventional and smart burs.
Materials and methods


A total of 40 extracted permanent molars with occlusal caries were selected for this study. These teeth were split at the center of carious lesion buccolingually, in order to obtain two similar halves. Thus, 80 samples were obtained in this way and were randomly divided into 2 groups of 40 samples each. Caries was removed using conventional burs in group I and polymer bur Smartprep (SS white) in group II. The time involved in caries removal was measured for both the groups. After excavation of all carious lesions, the samples were decalcified, dehydrated, and embedded in paraffin wax from which thin sections of 5 μm were obtained, which were histologically evaluated for bacterial presence under a light microscope.
Results


An intergroup comparison between conventional bur (group I) and smart bur (group II) showed a statistically nonsignificant difference in terms of the presence of microorganisms after caries removal with a  p  value of 0.073638 ( p  > 0.05). However, the time taken for caries removal was significantly more for smart burs than diamond burs with a  p  value of 0.001 ( p  < 0.05).
Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
How to cite this article


Somani R, Chaudhary R, Jaidka S,  et al.  Comparative Microbiological Evaluation after Caries Removal by Various Burs. Int J Clin Pediatr Dent 2019;12(6):524-527.",2019,"Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
",['40 extracted permanent molars with occlusal caries'],[],"['time taken for caries removal', 'time involved in caries removal', 'caries removal efficacy', 'presence of microorganisms after caries removal']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",40.0,0.0157617,"Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
","[{'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Somani', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Jaidka', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Deepti J', 'Initials': 'DJ', 'LastName': 'Singh', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1678']
1892,32440101,Dupilumab: Clinical Efficacy of Blocking IL-4/IL-13 Signalling in Chronic Rhinosinusitis with Nasal Polyps.,"In September 2019,  The Lancet  published details of two large Phase III double-blind placebo-controlled studies (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52) confirming the clinical efficacy of the biologic dupilumab in simultaneously blocking both IL-4/IL-13 signalling in chronic rhinosinusitis with nasal polyps (CRSwNP). The studies demonstrated that dupilumab (Dupixent ® , Sanofi and Regeneron) 300mg subcutaneously administered was clinically effective when added for patients with moderate to severe CRSwNP already maintained on the standard intranasal steroid mometasone furoate. Duration of treatment ranged from injections either 2 weekly for 24 weeks (SINUS-24) or every 2 weeks for 52 weeks or finally every 2 weeks for 24 weeks stepping down thereafter to every 4 weeks for a further 28 weeks (SINUS-52). Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased. In patients with co-existent asthma, lung function and asthma control scores improved. This is consistent with the one airway hypothesis of shared T2 inflammatory programmes driving both disease syndromes. The studies formed the basis for FDA registration and clinical launch in the US, and EMA approval in Europe. Dupilumab presents a significant new treatment option in an area of urgent unmet therapeutic need in CRSwNP. Should dupilumab prove to be as effective in the real-life clinical environment as it has been in the studies, then a paradigm shift from sinonasal surgery to medical treatment of CRSwNP may need to occur in the ENT community. Questions in relation to best patient selection, combined upper and lower airway therapeutic pathways, long-term safety along with health economics and cost constraints ought now to be addressed.",2020,Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased.,"['Chronic Rhinosinusitis with Nasal Polyps', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['Blocking IL-4/IL-13 Signalling', 'dupilumab (Dupixent ® , Sanofi and Regeneron', 'standard intranasal steroid mometasone furoate']",['lung function and asthma control scores'],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4325130', 'cui_str': 'Dupixent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.017168,Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased.,"[{'ForeName': 'Harsha H', 'Initials': 'HH', 'LastName': 'Kariyawasam', 'Affiliation': 'Department of Specialist Allergy and Clinical Immunology, Royal National ENT Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Gane', 'Affiliation': 'Department of Rhinology, Royal National ENT Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}]","Drug design, development and therapy",['10.2147/DDDT.S243053']
1893,32440111,Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.,"Purpose


The clinical manifestation of COPD can differ by gender, with women experiencing worse lung function and health-related quality of life than men. Additionally, women tend to report more symptoms given the same disease severity. Accordingly, the impact of gender on efficacy and safety in patients with moderate-to-very-severe COPD was examined following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily (BID) or placebo.
Patients and Methods


GLY and placebo pooled data from the replicate 12-week GOLDEN 3 and 4 studies (n=861) were grouped by gender. Endpoints reported were change from baseline in trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores. Safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs.
Results


Men (placebo: 54.7%; GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids. GLY treatment resulted in significant, clinically important improvements in trough FEV 1 , regardless of gender. Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women. Although EXACT-RS improved in both genders, only women experienced a significant improvement. Overall, GLY was well tolerated with a numerically lower incidence of AEs in men than women.
Conclusion


Treatment with nebulized GLY resulted in lung function, SGRQ total score, and EXACT-RS total score improvements regardless of gender. However, only EXACT-RS showed significantly greater improvements in women compared with men. Treatment with GLY was generally well tolerated across genders. These data support the efficacy and safety of GLY 25 µg BID in patients with moderate-to-very-severe COPD, independent of gender. Gender similarities in airflow improvement and differences in symptom-reporting augment the evidence supporting the consideration of individualized treatment plans for COPD patients.",2020,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","['women experiencing worse lung function and health-related quality of life than men', 'Patients with COPD Receiving', 'men than women', 'patients with moderate-to-very-severe COPD', 'GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids', 'COPD patients']","['nebulized GLY', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['SGRQ total score', 'incidence of adverse events (AEs) and serious AEs', 'lung function, SGRQ total score, and EXACT-RS total score', 'efficacy and safety', ""trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores"", 'Lung Function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",861.0,0.103846,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","[{'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S240303']
1894,32075475,"A phase 2a, randomized, double-blind, placebo-controlled trial of the efficacy and safety of the oral gonadotropin-releasing hormone antagonist, ASP1707, in postmenopausal female patients with rheumatoid arthritis taking methotrexate.","Objectives:  Many patients with rheumatoid arthritis (RA) are not able to achieve long-term disease remission. This phase 2a study (NCT02884635) evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of the novel, oral, gonadotropin-releasing hormone antagonist, ASP1707, in combination with methotrexate (MTX) for treatment of RA. Methods:  Postmenopausal women with RA who had been receiving MTX for ≥90 days were randomized to ASP1707 30 mg twice daily or placebo for 12 weeks. The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Secondary endpoints included: ACR20, ACR50, and ACR70 response rates; disease activity score (DAS)28-CRP; DAS28-ESR; Tender or Swollen Joint Counts; and remission rates. Results:  Of 105 patients screened, 72 were randomized to ASP1707 30 mg twice daily ( n  = 37) or placebo ( n  = 35). ASP1707 did not improve ACR20, ACR50, or ACR70 response rates at any time point and did not improve any secondary efficacy endpoint. Plasma luteinizing hormone (LH) concentration decreased >90% in >90% of patients receiving ASP1707, with a rapid decrease to <1 IU/L at week 1 that remained stable throughout the treatment. Conclusion:  In the current study, ASP1707 did not demonstrate a clinical benefit.",2020,"ASP1707 did not improve ACR20, ACR50, or ACR70 response rates at any time point and did not improve any secondary efficacy endpoint.","['postmenopausal female patients with rheumatoid arthritis taking methotrexate', '105 patients screened, 72 were randomized to ASP1707 30', 'patients with rheumatoid arthritis (RA', 'Postmenopausal women with RA who had been receiving MTX for ≥90 days']","['ASP1707 30', 'oral gonadotropin-releasing hormone antagonist, ASP1707', 'placebo', 'ASP1707', 'methotrexate (MTX']","['efficacy and safety', 'American College of Rheumatology 20% improvement criteria (ACR20) response rate', 'Plasma luteinizing hormone (LH) concentration', 'ACR20, ACR50, or ACR70 response rates', 'ACR20, ACR50, and ACR70 response rates; disease activity score (DAS)28-CRP; DAS28-ESR; Tender or Swollen Joint Counts; and remission rates', 'efficacy, safety, pharmacokinetics, and pharmacodynamics']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0857694', 'cui_str': 'Plasma luteinising hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",72.0,0.343139,"ASP1707 did not improve ACR20, ACR50, or ACR70 response rates at any time point and did not improve any secondary efficacy endpoint.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Chieri', 'Initials': 'C', 'LastName': 'Higashitani', 'Affiliation': 'Clinical Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Clinical Pharmacology and Exploratory Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Komatsu', 'Affiliation': 'Clinical Pharmacology, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Rio', 'Initials': 'R', 'LastName': 'Akazawa', 'Affiliation': 'Data Science, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lademacher', 'Affiliation': 'Medical Science, Astellas Pharma, Inc., Northbrook, IL, USA.'}]",Modern rheumatology,['10.1080/14397595.2020.1733214']
1895,31503332,Safety and efficacy of trabectedin when administered in the inpatient versus outpatient setting: Clinical considerations for outpatient administration of trabectedin.,"BACKGROUND


The results of the randomized, phase 3 ET743-SAR-3007 trial demonstrated that trabectedin had a significantly longer progression-free survival (PFS) compared with dacarbazine in patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy. Patients randomized to trabectedin received a 24-hour intravenous infusion either in an inpatient or outpatient setting. Herein, the authors reported the safety, efficacy, and patient-reported outcomes based on first infusion site of care.
METHODS


Patients were randomized 2:1 to trabectedin (at a dose of 1.5 mg/m 2  ) or dacarbazine (1 g/m 2  over 20-120 minutes) with overall survival (OS) as the primary endpoint and PFS, time to disease progression, objective response rate, duration of response, safety, and patient-reported symptom scoring as secondary endpoints. The setting of the trabectedin infusion was based on institutional preference and categorized based on the setting of the first infusion.
RESULTS


Of the 378 patients who were treated with trabectedin, 100 (27%) and 277 (73%), respectively, first received trabectedin in the inpatient and outpatient setting. No differences were observed with regard to PFS or OS based on site of care. The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively. Grade 3/4 adverse events (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]) were reported in 87 inpatients (87%) compared with 219 outpatients (79%); grade 3/4 serious adverse events were reported in 43 inpatients (43%) and 92 outpatients (33%). Extravasation occurred in 0 inpatients and 5 outpatients (2%), whereas the incidence of catheter-related complications was similar between groups (16% vs 15%).
CONCLUSIONS


Although the majority of patients who were randomized to trabectedin received outpatient therapy, the outcomes of the current study suggested equivalent safety and efficacy in either setting.",2019,"The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively.","['Patients', 'patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy', '378 patients who were treated with trabectedin, 100 (27%) and 277 (73%), respectively, first received trabectedin in the inpatient and outpatient setting', 'inpatient versus outpatient setting']","['trabectedin', 'dacarbazine']","['longer progression-free survival (PFS', 'median PFS', 'safety, efficacy', 'median OS', 'Safety and efficacy', 'PFS, time to disease progression, objective response rate, duration of response, safety, and patient-reported symptom scoring', 'grade 3/4 serious adverse events', 'Extravasation', 'incidence of catheter-related complications', 'Grade 3/4 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023269', 'cui_str': 'LMS - Leiomyosarcoma'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma (disorder)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",219.0,0.0655235,"The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively.","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, Institute of Cancer Research, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Medical Oncology and Hematology, Monter Cancer Center, Northwell Health, New Hyde Park, New York.'}, {'ForeName': 'Shreyaskumar R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Clinical Oncology, Janssen Research & Development LLC, Raritan, New Jersey.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'McGowan', 'Affiliation': 'Medical Group Oncology, Janssen Scientific Affairs LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Shalaby', 'Affiliation': 'Medical Group Oncology, Janssen Scientific Affairs LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Knoblauch', 'Affiliation': 'Clinical Oncology, Janssen Research & Development LLC, Raritan, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32462']
1896,32440127,The Effect of Perceptual-Motor Training on Executive Functions in Children with Non-Verbal Learning Disorder.,"Purpose


Research shows an atypical cognitive process in children with nonverbal learning disorder (NLD) compared to typically developing children, but a wealth of information indicates that physical activity can influence cognitive processes. However, little is known about the effects of perceptual-motor training and its impact on the cognitive process of children with NLD. Thus, the major goals of this study are to compare the executive functions (EFs) in children with NLD with typically developing children and then to investigate the effect of perceptual-motor training on EFs of children with NLD.
Methods


To achieve the first goal, 400 typically developing (IQ >80) and NLD children (7-13 years old) were randomly selected in the city of Mashhad, Iran, during the period 2017-2018. As for the second goal, 50 children with NLD were randomly assigned to an experimental or control group. To evaluate executive functions, Delis-Kaplan executive function system test was used at the pretest, posttest, and 3-month follow-up. The experimental group received the Werner and Reini's perceptual-motor training program in sixteen 45-min sessions (three sessions per week), but the control group did not receive any intervention.
Results


The results showed that children with NLD were significantly weaker than typically developing children in London Tower Test (t (38) = -4.662, p <0.01), Trail Making Test (t (33.926) = -3.11, p <0.01), Card Sorting Test (t (38) = -3.427, p <0.01), and Stroop Color Test (t (30.035) = -5.876, p <0.01). The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
Conclusion


Children with NLD have problems in EFs, but perceptual-motor training can be used as an effective intervention for these children.",2020,"The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
","['Children with Non-Verbal Learning Disorder', 'children with \ufeffnonverbal \ufefflearning \ufeffdisorder (NLD', '50 children with NLD', 'children with NLD', 'children with NLD with typically developing children', '400 typically developing (IQ >80) and NLD children (7-13 years old) were randomly selected in the city of Mashhad, Iran, during the period 2017-2018']","['control group did not receive any intervention', ""Werner and Reini's perceptual-motor training program"", 'perceptual-motor training', 'Perceptual-Motor Training']",['Executive Functions'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043119', 'cui_str': 'Werner syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}]",50.0,0.0130184,"The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
","[{'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Soltani Kouhbanani', 'Affiliation': 'Department of Educational Sciences, Educational Sciences and Psychology Faculty, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyedeh Manizheh', 'Initials': 'SM', 'LastName': 'Arabi', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Zarenezhad', 'Affiliation': 'Department of Educational Sciences, Educational Sciences and Psychology Faculty, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Khosrorad', 'Affiliation': 'Department of Health Education, Educational Neuroscience Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S252662']
1897,31309332,"Letter to the Editor concerning ""Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study"" by Fischgrund JS, et al. [Eur Spine J; (2018) 27(5): 1146-1156].",,2019,,"['Eur Spine J; (2018) 27(5', 'chronic low back pain']","['Letter to the Editor concerning ""Intraosseous basivertebral nerve ablation']",[],"[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",[],,0.158246,,"[{'ForeName': 'Yongchao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopaedics, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedics, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China. dr.tan@139.com.'}, {'ForeName': 'Baogan', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': 'Department of Spinal Surgery, The Third Medical Center of PLA General Hospital, 69 Yongding Road, Beijing, 100039, China. pengbaogan76611@163.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06061-7']
1898,32440199,Oxycodone vs Sufentanil in Patient-Controlled Intravenous Analgesia After Gynecological Tumor Operation: A Randomized Double-Blind Clinical Trial.,"Background


This study aims to compare analgesic effect and side effects of oxycodone and sufentanil in transition analgesia and patient-controlled intravenous analgesia (PCIA) after gynecological tumor operation under general anesthesia.
Patients and Methods


A prospective, randomized, double-blind research was conducted. Patients undergoing elective gynecological tumor surgery were randomized into four groups: Group S (sufentanil transition analgesia and sufentanil PCIA), Group OS (oxycodone transition analgesia and sufentanil PCIA), Group SO (sufentanil transition analgesia and oxycodone PCIA) and Group O (oxycodone transition analgesia and oxycodone PCIA). The primary outcomes were Numerical Rating Scale (NRS) at rest and coughing, accumulated opioid consumption in PCIA and patients' satisfaction.
Results


Patients in Group OS and Group O showed shorter time of consciousness recovery and extubation after surgery. Accumulated opioid consumption in PCIA (equal to morphine) in Group SO and Group O was significantly less than that in Group S and Group OS. Patients in Group O showed lower NRS at rest and coughing, but higher patients' satisfaction 3, 24 and 48 hours after surgery. Patients in Group SO and Group O showed a shorter time of intestinal recovery, first feeding and first-time movement.
Conclusion


Both oxycodone and sufentanil provided adequate pain relief in transitional analgesia and PCIA treatment after surgery. Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.",2020,Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.,"['transitional analgesia and PCIA treatment after surgery', 'Patient\ufeff-Controlled Intravenous Analgesia', 'transition analgesia and patient-controlled intravenous analgesia (PCIA) after gynecological tumor operation under general anesthesia', 'PCIA after gynecological tumor operation under general anesthesia', 'Patients undergoing elective gynecological tumor surgery']","['oxycodone and sufentanil', 'sufentanil', 'Oxycodone vs Sufentanil', 'Oxycodone without background infusion', 'Group S (sufentanil transition analgesia and sufentanil PCIA), Group OS (oxycodone transition analgesia and sufentanil PCIA), Group SO (sufentanil transition analgesia and oxycodone PCIA) and Group O (oxycodone transition analgesia and oxycodone PCIA', 'morphine']","['analgesic drug consumption and faster recovery', ""Numerical Rating Scale (NRS) at rest and coughing, accumulated opioid consumption in PCIA and patients' satisfaction"", 'shorter time of intestinal recovery, first feeding and first-time movement', 'shorter time of consciousness recovery and extubation', 'lower NRS at rest and coughing', 'adequate pain relief']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.30439,Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.,"[{'ForeName': 'Sha-Jie', 'Initials': 'SJ', 'LastName': 'Dang', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Rui-Li', 'Initials': 'RL', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Hui-Yu', 'Initials': 'HY', 'LastName': 'Yue', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Si-Yuan', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesia, The Second Affiliated Hospital of Xian Jiaotong University, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Han', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S236933']
1899,31466930,Comparison of transverse maxillary dental arch width changes with self-ligating and conventional brackets in patients requiring premolar extraction - A randomised clinical trial.,"OBJECTIVE


The purpose of this study was to evaluate, the change in the transverse maxillary arch dimensions, in patients requiring all first premolar extractions when using Active and Passive Self-ligating brackets, and comparing them with Conventional brackets.
MATERIALS AND METHODS


This study was a non-blinded randomised clinical trial, which consisted of 42 patients (21 males and 21 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups with 14 patients each. In Group 1 - Conventional brackets (3M Unitek), in Group 2 - Passive Self-ligation brackets: Smart Clip (3M Unitek), and in Group 3 - Active Self-ligation brackets: Empower AO (American Orthodontics) were bonded. All brackets had MBT prescription and 0.02"" slot size. Dental study models were taken before the start of treatment and after six months of retraction. Inter-canine and intermolar widths were measured in all the three groups in the above mentioned stages.
RESULTS


As compared to Conventional brackets, Self-ligating brackets (Passive and Active) showed greater increase in the transverse arch widths. Furthermore, between Passive and Active Self-ligating brackets, Passive Self-ligating brackets - Smart Clip (Group 2) showed a greater increment in the transverse arch dimensions, with an increase of 4.89mm in the inter-canine width and 3.4mm in intermolar width.
CONCLUSION


Significant difference was found between Self-ligating brackets and the Conventional bracket system regarding maxillary arch width dimensional changes. Passive Self-ligating brackets - Smart Clip (Group 2) showed the highest and inter-molar width increase.",2019,"As compared to Conventional brackets, Self-ligating brackets (Passive and Active) showed greater increase in the transverse arch widths.","['42 patients (21 males and 21 females) within the age group of 16-25 years, having bimaxillary protrusion', 'patients requiring premolar extraction\xa0', 'patients requiring all first premolar extractions when using Active and Passive Self-ligating brackets, and comparing them with Conventional brackets']","['self-ligating and conventional brackets', 'Passive Self-ligating brackets\xa0-\xa0Smart Clip']","['transverse arch widths', 'transverse arch dimensions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3697648', 'cui_str': 'Bimaxillary protrusion'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",42.0,0.0360277,"As compared to Conventional brackets, Self-ligating brackets (Passive and Active) showed greater increase in the transverse arch widths.","[{'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Bashir', 'Affiliation': 'Institute of Dental studies and Technologies, 201201 Modinagar, UP, India. Electronic address: rehanabashir21@gmail.com.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Sonar', 'Affiliation': 'Institute of Dental studies and Technologies, 201201 Modinagar, UP, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': 'Institute of Dental studies and Technologies, 201201 Modinagar, UP, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Institute of Dental studies and Technologies, 201201 Modinagar, UP, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Singla', 'Affiliation': 'Institute of Dental studies and Technologies, 201201 Modinagar, UP, India.'}]",International orthodontics,['10.1016/j.ortho.2019.08.006']
1900,31466932,"Comparing the plaque-removal ability of a triple-headed toothbrush versus a conventional manual toothbrush in adolescents with fixed orthodontic appliances: A single-center, randomized controlled clinical trial.","OBJECTIVE


The objective of this trial was to compare the plaque removal ability of a triple-headed toothbrush to a conventional manual toothbrush in adolescents with fixed orthodontic appliances.
MATERIALS AND METHODS


Sixty adolescent patients undergoing orthodontic treatment were randomly assigned to brush one time with either a conventional manual toothbrush or a triple-headed toothbrush. The main outcome was the post-brushing plaque index as measured by the Silness-Löe plaque index.
RESULTS


Sixty patients (mean age, 14.2; standard deviation, 1.65) were randomized in a 1:1 ratio to either a manual toothbrush group or a triple-headed toothbrush group. Baseline characteristics were similar between the two groups. There were no dropouts. The mean post-brushing plaque index was 0.84 (95% CI, 0.67-1.02; SD, 0.60) for the conventional manual toothbrush group, and 0.31 (95% CI, 0.13-0.49; SD, 0.48) for the triple-headed toothbrush group. There was a statistically significant difference in the mean plaque index of 0.53 (95% CI, 0.28-0.78; P<0.001) between the two groups after brushing. No harms were observed.
CONCLUSION


The results of this study indicate strong evidence that the triple-headed toothbrush leads to a significantly lower plaque index compared to the conventional manual toothbrush post-brushing.",2019,"There was a statistically significant difference in the mean plaque index of 0.53 (95% CI, 0.28-0.78; P<0.001) between the two groups after brushing.","['Sixty patients (mean age, 14.2; standard deviation, 1.65', 'Sixty adolescent patients undergoing orthodontic treatment', 'adolescents with fixed orthodontic appliances']","['manual toothbrush group or a triple-headed toothbrush group', 'triple-headed toothbrush to a conventional manual toothbrush', 'triple-headed toothbrush versus a conventional manual toothbrush', 'conventional manual toothbrush or a triple-headed toothbrush']","['plaque index', 'mean post-brushing plaque index', 'post-brushing plaque index as measured by the Silness-Löe plaque index', 'plaque removal ability', 'mean plaque index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C0490733', 'cui_str': 'Manual toothbrush (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",60.0,0.108868,"There was a statistically significant difference in the mean plaque index of 0.53 (95% CI, 0.28-0.78; P<0.001) between the two groups after brushing.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Terrana', 'Affiliation': 'Seton Hill Center for Orthodontics, Greensburg, PA, USA. Electronic address: Aterrana7@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rinchuse', 'Affiliation': 'Seton Hill Center for Orthodontics, Greensburg, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zullo', 'Affiliation': 'Seton Hill Center for Orthodontics, Biostatistics, Greensburg, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Marrone', 'Affiliation': 'Seton Hill Center for Orthodontics, Greensburg, PA, USA.'}]",International orthodontics,['10.1016/j.ortho.2019.08.010']
1901,31468106,Short-term strength and balance training does not improve quality of life but improves functional status in individuals with diabetic peripheral neuropathy: a randomised controlled trial.,"AIMS/HYPOTHESIS


The aim of this study was to test the effectiveness of a structured strength and balance training intervention in improving health-related quality of life (HRQoL) and functional status in individuals with diabetic peripheral neuropathy (DPN).
METHODS


The study was a single-blind parallel-group randomised controlled trial comparing 2 months of once-weekly home-based strength and balance training against standard medical therapy. Participants were patients with physician-diagnosed type 2 diabetes and neuropathy recruited from five public sector institutions in Singapore between July 2014 and October 2017. Participants were block-randomised to intervention or control arms. Outcomes were assessed at baseline, 2 months and 6 months by a trained assessor blinded to group assignment. Primary outcomes were change in physical component summary (PCS) score of SF-36v2 (a 36-item generic HRQoL instrument that has been validated for use in Singapore) and EQ-5D-5L index score (derived from a five-item generic HRQoL instrument [EQ-5D-5L]) over 6 months. Secondary outcomes were change in functional status (timed up-and-go [TUG], five times sit-to-stand [FTSTS], functional reach, static balance, ankle muscle strength and knee range of motion) and balance confidence over 6 months. Mean differences in scores between groups were compared using mixed models.
RESULTS


Of the 143 participants randomised (intervention, n = 70; control, n = 73), 67 participants were included in each arm for the final intention-to-treat analysis. The two groups were similar, except in terms of sex. There were no significant differences between groups on the primary outcomes of PCS score (mean difference [MD] 1.56 [95% CI -1.75, 4.87]; p = 0.355) and EQ-5D-5L index score (MD 0.02 [95% CI -0.01, 0.06]; p = 0.175). There were significant improvements in TUG test performance (MD -1.14 [95% CI -2.18, -0.1] s; p = 0.032), FTSTS test performance (MD -1.31 [95% CI -2.12, -0.51] s; p = 0.001), ankle muscle strength (MD 4.18 [95% CI 0.4, 7.92] N; p = 0.031), knee range of motion (MD 6.82 [95% CI 2.87, 10.78]°; p = 0.001) and balance confidence score (MD 6.17 [95% CI 1.89, 10.44]; p = 0.005). No adverse events due to study participation or study intervention were reported.
CONCLUSIONS/INTERPRETATION


Short-term structured strength and balance training did not influence HRQoL but produced sustained improvements in functional status and balance confidence at 6 months. More intensive interventions may be needed to influence HRQoL in these individuals. However, this intervention may be a useful treatment option for individuals with DPN to reduce the risk of falls and injuries.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02115932 FUNDING: This work was supported by the National Medical Research Council, Singapore.",2019,Short-term structured strength and balance training did not influence HRQoL but produced sustained improvements in functional status and balance confidence at 6 months.,"['individuals with diabetic peripheral neuropathy', 'individuals with DPN', '67 participants were included in each arm for the final intention-to-treat analysis', '143 participants randomised (intervention, n\u2009=\u200970; control, n\u2009=\u200973', 'Participants were patients with physician-diagnosed type 2 diabetes and neuropathy recruited from five public sector institutions in Singapore between July 2014 and October 2017', 'individuals with diabetic peripheral neuropathy (DPN']","['structured strength and balance training intervention', 'Short-term strength and balance training', 'once-weekly home-based strength and balance training against standard medical therapy']","['knee range of motion', 'change in physical component summary (PCS) score of SF-36v2 (a 36-item generic HRQoL instrument that has been validated for use in Singapore) and EQ-5D-5L index score', 'TUG test performance', 'PCS score', 'change in functional status (timed up-and-go [TUG], five times sit-to-stand [FTSTS], functional reach, static balance, ankle muscle strength and knee range of motion) and balance confidence', 'functional status and balance confidence', 'health-related quality of life (HRQoL) and functional status', 'quality of life', 'EQ-5D-5L index score', 'ankle muscle strength', 'balance confidence score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",67.0,0.244159,Short-term structured strength and balance training did not influence HRQoL but produced sustained improvements in functional status and balance confidence at 6 months.,"[{'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Venkataraman', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Tahir Foundation Building (MD1), 12 Science Drive 2, Singapore, 117549, Republic of Singapore. ephkv@nus.edu.sg.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Tahir Foundation Building (MD1), 12 Science Drive 2, Singapore, 117549, Republic of Singapore.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Subramaniam', 'Initials': 'S', 'LastName': 'Tavintharan', 'Affiliation': 'Diabetes Centre, Khoo Teck Puat Hospital, Singapore, Republic of Singapore.'}, {'ForeName': 'Kurumbian', 'Initials': 'K', 'LastName': 'Chandran', 'Affiliation': 'Department of Medicine, Ng Teng Fong General Hospital, Singapore, Republic of Singapore.'}, {'ForeName': 'Siew Wai', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': 'SingHealth Polyclinics-Bukit Merah, Singapore, Republic of Singapore.'}, {'ForeName': 'Melissa S L A', 'Initials': 'MSLA', 'LastName': 'Phua', 'Affiliation': 'Allied Health Services and Pharmacy, Foot Care and Limb Design Centre, Podiatry Service, Tan Tock Seng Hospital, Singapore, Republic of Singapore.'}, {'ForeName': 'Hwee Lin', 'Initials': 'HL', 'LastName': 'Wee', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Tahir Foundation Building (MD1), 12 Science Drive 2, Singapore, 117549, Republic of Singapore.'}, {'ForeName': 'Gerald C H', 'Initials': 'GCH', 'LastName': 'Koh', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Tahir Foundation Building (MD1), 12 Science Drive 2, Singapore, 117549, Republic of Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore, Republic of Singapore.'}]",Diabetologia,['10.1007/s00125-019-04979-7']
1902,32440233,The Effect of a Midwife-Based Group Discussion Education on Sexual Dysfunction Beliefs in Rural Postmenopausal Women.,"Introduction


Correcting sexual beliefs can affect women's sexual function. There are very limited interventional studies on correcting the sexual dysfunction beliefs in postmenopausal women living in rural areas. Therefore, the present study was carried out with the aim of investigating the effect of a midwife-based group education on sexual dysfunction beliefs in one group of rural postmenopausal women.
Methods


The present study was a quasi-experimental pre-post design without a control group. The study population included rural menopausal women who referred to rural health centers. The study sample consisted of 50 participants who have all received education program. The education was held in six group discussion sessions. The data gathering tool used in this study was the Sexual Dysfunctional Beliefs Questionnaire which was completed before and after the education. This questionnaire consists of 33 items and includes 6 subscales.
Results


The mean age of participants was 53.26 years. Approximately half of the participants (48%) had primary education. The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001). The mean scores of sexual conersations, affection primacy, motherhood-related beliefs, sexual desire and pleasure as sin beliefs, age-related beliefs, and body image beliefs before intervention were 14.38, 21.38, 13.9, 23.64, 20.74, 17.04, respectively, and after intervention were 6.9, 11.80, 8.64, 12.48, 7.7, 9.40, respectively.
Conclusion


Rural postmenopausal women had problems with sexual dysfunction beliefs. A midwife-based group discussion education on this matter had significantly improved the sexual dysfunction beliefs in them. Further studies are needed in this regard.",2020,"The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001).","['postmenopausal women living in rural areas', 'Rural postmenopausal women had problems with sexual dysfunction beliefs', 'Rural Postmenopausal Women', '50 participants who have all received education program', 'one group of rural postmenopausal women', 'rural menopausal women who referred to rural health centers']","['midwife-based group education', 'Midwife-Based Group Discussion Education']","['Sexual Dysfunction Beliefs', 'Sexual Dysfunctional Beliefs Questionnaire', 'mean scores of sexual conersations, affection primacy, motherhood-related beliefs, sexual desire and pleasure as sin beliefs, age-related beliefs, and body image beliefs', 'mean scores of sexual dysfunction beliefs', 'sexual dysfunction beliefs']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0035960', 'cui_str': 'Rural health center'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337490', 'cui_str': 'Motherhood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",50.0,0.0319069,"The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sasanpour', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Nezal', 'Initials': 'N', 'LastName': 'Azh', 'Affiliation': 'Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",International journal of women's health,['10.2147/IJWH.S242621']
1903,32440135,The Advantage of Implementation of Enhanced Recovery After Surgery (ERAS) in Acute Pain Management During Elective Cesarean Delivery: A Prospective Randomized Controlled Trial.,"Objective


The aim of this study was to test whether the implementation of an enhanced recovery after surgery (ERAS) protocol for patients undergoing elective cesarean delivery has a positive impact on the postoperative status of the patients in terms of pain management, hospital stay, hospitalization costs, and adverse reactions.
Methods


Patients who underwent elective cesarean delivery were randomized into two groups - ERAS group and control group - and the groups were managed with the ERAS protocol and traditional protocol, respectively.
Results


Compared to the control group, the ERAS group had significantly fewer patients with intraoperative nausea, pain of visual analog scale (VAS) scores, and VAS grade >3 during rest in the first 24 h and during motion in the first 24 and 48 h after surgery. There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus. None of the patients in either group had postoperative vomiting. Patient satisfaction rated as per the VAS was significantly higher in the ERAS group than in the control group. The total length of stay, postoperative length of stay, and the cost of anesthesia in both groups were comparable. Further, the average daily hospitalization cost was significantly lower in the ERAS group than in the control group.
Conclusion


The ERAS protocol shows promise and appears to be worthwhile for widespread implementation among patients undergoing elective cesarean delivery; it was found to be beneficial in reducing the postoperative pain, incidence of intraoperative nausea, and average cost of hospitalization and also improved patient satisfaction.",2020,"There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus.","['Acute Pain Management', 'patients undergoing elective cesarean delivery', 'Methods\n\n\nPatients who underwent elective cesarean delivery']","['ERAS group and control group -\xa0and the groups were managed with the ERAS protocol and traditional protocol, respectively', 'ERAS', 'Surgery (ERAS', 'surgery (ERAS) protocol']","['postoperative vomiting', 'pain management, hospital stay, hospitalization costs, and adverse reactions', 'Patient satisfaction rated as per the VAS', 'total length of stay, postoperative length of stay, and the cost of anesthesia', 'average daily hospitalization cost', 'intraoperative nausea, pain of visual analog scale (VAS) scores, and VAS grade >3 during rest', 'requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus', 'postoperative pain, incidence of intraoperative nausea']","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0411586,"There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus.","[{'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Hou', 'Affiliation': ""Department of Obstetrics, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chulian', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}]",Therapeutics and clinical risk management,['10.2147/TCRM.S244039']
1904,31467115,Efficacy and safety of inhaled α1-antitrypsin in patients with severe α1-antitrypsin deficiency and frequent exacerbations of COPD.,"Patients with inherited α1-antitrypsin (AAT) deficiency (ZZ-AATD) and severe chronic obstructive pulmonary disease (COPD) frequently experience exacerbations. We postulated that inhalation of nebulised AAT would be an effective treatment.We randomly assigned 168 patients to receive twice-daily inhalations of 80 mg AAT solution or placebo for 50 weeks. Patients used an electronic diary to capture exacerbations. The primary endpoint was time from randomisation to the first event-based exacerbation. Secondary endpoints included change in the nature of the exacerbation as defined by the Anthonisen criteria. Safety was also assessed.Time to first moderate or severe exacerbation was a median of 112 days (interquartile range (IQR) 40-211 days) for AAT and 140 days (IQR 72-142 days) for placebo (p=0.0952). The mean yearly rate of all exacerbations was 3.12 in the AAT-treated group and 2.67 in the placebo group (p=0.31). More patients receiving AAT reported treatment-related treatment-emergent adverse events compared to placebo (57.5%  versus  46.9%, respectively) and they were more likely to withdraw from the study. After the first year of the study, when modifications to the handling of the nebuliser were introduced, the rate of safety events in the AAT-treated group dropped to that of the placebo group.We conclude that in AATD patients with severe COPD and frequent exacerbations, AAT inhalation for 50 weeks showed no effect on time to first exacerbation but may have changed the pattern of the episodes.",2019,"More patients receiving AAT reported treatment-related TEAEs (Treatment Emergent Adverse Events) compared to placebo (57·5%  versus  46·9%, respectively) and they were more likely to withdraw from the study.","['Patients with inherited alpha-1-antitrypsin (AAT) deficiency (ZZ-AATD) and severe chronic obstructive pulmonary disease (COPD) frequently suffer from exacerbations', 'patients with severe alpha-1-antitrypsin deficiency and frequent exacerbations of Chronic Obstructive Pulmonary Disease']","['placebo', 'nebulised AAT', 'inhaled alpha-1-antitrypsin', 'AAT solution or placebo']","['time from randomisation to the first event-based exacerbation', 'Efficacy and safety', 'mean yearly rate of all exacerbations', 'Time to first moderate or severe exacerbation', 'Safety', 'rate of safety events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221757', 'cui_str': 'alpha 1-Antitrypsin Deficiency'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0002191', 'cui_str': 'alfa1 antitrypsin'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",168.0,0.349897,"More patients receiving AAT reported treatment-related TEAEs (Treatment Emergent Adverse Events) compared to placebo (57·5%  versus  46·9%, respectively) and they were more likely to withdraw from the study.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stolk', 'Affiliation': 'Dept of Pulmonology, Member of European Reference Network LUNG, Leiden University Medical Centre, Leiden, NL j.stolk@lumc.nl.'}, {'ForeName': 'Naveh', 'Initials': 'N', 'LastName': 'Tov', 'Affiliation': 'Dept of Clinical Development, Kamada Ltd, Rehovot, Israel.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Dept of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Fernandez', 'Affiliation': 'Independent Consultant, Penn, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'MacNee', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Piitulainen', 'Affiliation': 'Dept of Respiratory Medicine and Allergology, Malmö, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Dept of Respiratory Medicine Y, Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Dept of Medicine, Pulmonary and Critical Care Medicine, Member of the German Center for Lung Diseases (DZL), University Medical Centre Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bals', 'Affiliation': 'Internal Medicine V - Pulmonology, Member of the German Center for Lung Diseases (DZL), Hospital of the University of the Saarland, Homburg, Germany.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'McElvaney', 'Affiliation': 'Dept of Respiratory Medicine, Beaumont Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stockley', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}]",The European respiratory journal,['10.1183/13993003.00673-2019']
1905,32440230,The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy: Results from a Prospective Controlled Study.,"Objective


The aim of this study was to determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy.
Patients and Methods


A prospective controlled study was conducted in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.
Results


A total of 88 patients were studied. Sixty-two cases were done under general anesthesia (control group) and 26 cases were performed with spinal anesthesia and the use of oxytocin infusion (study group). There was a statistically significant less mean fluid deficit in the study group than control group in the endometrial polypectomy patients (220±36 mL vs 392±178 mL, respectively, P value 0.010, 95% C.I.: 163-276) and the myomectomy patients (308±66 mL vs 564±371 mL, respectively, P value 0.003, 95% C.I.: 239-378). In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001). Regarding septal resection, there was no statistically significant difference in the mean fluid deficit between the two groups (P value 0.833).
Conclusion


Spinal anesthesia combined with intravenous oxytocin infusion in operative hysteroscopy results in a statistically significant reduction in the glycine fluid deficit than the general anesthesia. We also recommend studying the effects of this combination in operative hysteroscopy using bipolar devices with isotonic solutions.",2020,"In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001).","['Sixty-two cases were done under general anesthesia (control group) and 26 cases were performed with', '88 patients were studied', 'Patients Undergoing Operative Hysteroscopy\ufeff', 'premenopausal patients who had', 'patients undergoing operative hysteroscopy']","['oxytocin', 'isotonic solutions', 'hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection', 'spinal anesthesia and the use of oxytocin infusion', 'oxytocin infusion', 'Oxytocin', 'oxytocin infusion and spinal anesthesia']","['fluid deficit', 'mean fluid deficit', 'glycine fluid deficit', 'Fluid Absorption']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",88.0,0.084883,"In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001).","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Al-Husban', 'Affiliation': 'Obstetrics and Gynecology Department, School of Medicine, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Abdelkarim', 'Initials': 'A', 'LastName': 'Aloweidi', 'Affiliation': 'Department of Anesthesia, School of Medicine, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ababneh', 'Affiliation': 'Department of Anesthesia, School of Medicine, The University of Jordan, Amman, Jordan.'}]",International journal of women's health,['10.2147/IJWH.S249619']
1906,31399848,"Answer to the letter to the editor of Y. Li et al. concerning ""Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study"" by Fischgrund JS, et al. [Eur Spine J; (2018) 27(5): 1146-1156].",,2019,,"['Eur Spine J; (2018) 27(5', 'chronic low back pain']",['Intraosseous basivertebral nerve ablation'],[],"[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",[],,0.105061,,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Fischgrund', 'Affiliation': 'Oakland University William Beaumont School of Medicine, 3535 West 13 Mile Road, Suite 744, Royal Oak, MI, 48073, USA. jsfischgrund37@gmail.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06063-5']
1907,31469027,"Effect of phytic acid on postprandial serum uric acid level in healthy volunteers: a randomized, double-blind, crossover study.","Phytic acid, a constituent of various plants, has been related to health benefits. Phytic acid has been shown to inhibit purine nucleotide metabolism in vitro and suppress elevation of plasma uric acid levels after purine administration in animal models. This study investigated the effect of phytic acid on postprandial serum uric acid (SUA) in humans. This randomized, double-blind, crossover design study included 48 healthy subjects with normal fasting SUA. Subjects consumed a control drink and a phytic acid drink with purine-rich food, and serum and urine uric acid levels were measured for 360 min after purine loading. Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study. Altogether, our findings suggest that phytic acid may play a beneficial role in controlling postprandial SUA.",2020,Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study.,"['humans', 'healthy volunteers', '48 healthy subjects with normal fasting SUA']",['phytic acid'],"['postprandial serum uric acid level', 'plasma uric acid levels', 'cumulative urinary uric acid excretion', 'postprandial SUA', 'Phytic acid', 'postprandial serum uric acid (SUA']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0031855', 'cui_str': 'Phytic Acid'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031855', 'cui_str': 'Phytic Acid'}]",48.0,0.202114,Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ikenaga', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Noguchi', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kakumoto', 'Affiliation': 'Tokushima Research Institute, Pharmaceuticals Division, Otsuka Pharmaceutical Co., Ltd, Tokushima, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kohda', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tsukikawa', 'Affiliation': 'Fukuoka Mirai Hospital Clinical Research Center, Souseikai Medical Corporation, Fukuoka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsuguma', 'Affiliation': 'Fukuoka Mirai Hospital Clinical Research Center, Souseikai Medical Corporation, Fukuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Health Evaluation Center, Osaka Gyoumeikan Hospital, Osaka, Japan.'}]","Nucleosides, nucleotides & nucleic acids",['10.1080/15257770.2019.1656337']
1908,29364767,Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging.,"BACKGROUND


Thrombectomy is currently recommended for eligible patients with stroke who are treated within 6 hours after the onset of symptoms.
METHODS


We conducted a multicenter, randomized, open-label trial, with blinded outcome assessment, of thrombectomy in patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted. Patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml, and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more were randomly assigned to endovascular therapy (thrombectomy) plus standard medical therapy (endovascular-therapy group) or standard medical therapy alone (medical-therapy group). The primary outcome was the ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability) at day 90.
RESULTS


The trial was conducted at 38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group). Endovascular therapy plus medical therapy, as compared with medical therapy alone, was associated with a favorable shift in the distribution of functional outcomes on the modified Rankin scale at 90 days (odds ratio, 2.77; P<0.001) and a higher percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2 (45% vs. 17%, P<0.001). The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18).
CONCLUSIONS


Endovascular thrombectomy for ischemic stroke 6 to 16 hours after a patient was last known to be well plus standard medical therapy resulted in better functional outcomes than standard medical therapy alone among patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion and a region of tissue that was ischemic but not yet infarcted. (Funded by the National Institute of Neurological Disorders and Stroke; DEFUSE 3 ClinicalTrials.gov number, NCT02586415 .).",2018,"The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18).
","['38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group', 'patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted', 'eligible patients with stroke who are treated within 6 hours after the onset of symptoms', 'Patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml, and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more were randomly assigned to']","['endovascular therapy (thrombectomy) plus standard medical therapy (endovascular-therapy group) or standard medical therapy alone (medical-therapy group', 'Endovascular therapy plus medical therapy']","['ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability', 'frequency of symptomatic intracranial hemorrhage', '90-day mortality rate', 'functional outcomes', 'serious adverse events', 'modified Rankin scale']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue (substance)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0657273,"The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18).
","[{'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kemp', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Jenny P', 'Initials': 'JP', 'LastName': 'Tsai', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ortega-Gutierrez', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Torbey', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Kim-Tenser', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Thabele', 'Initials': 'T', 'LastName': 'Leslie-Mazwi', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Amrou', 'Initials': 'A', 'LastName': 'Sarraj', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Ansari', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Zaharchuk', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Carrozzella', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bammer', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1713973']
1909,32440243,Results of a Single Arm Pilot Study of a Mobile Messaging Intervention for Hookah Tobacco Cessation in Young Adults.,"Background


Hookah tobacco use is common among young adults. Unlike cigarette smoking, there is limited evidence on mobile (ie, mHealth) interventions to promote cessation.
Objectives


This pilot study tested the preliminary effects of mobile messaging for cessation in young adult hookah smokers.
Methods


Young adults (N = 20) aged 18 to 30 years who smoke hookah at least monthly and have done so at least once in the past 30 days received a 6-week mHealth multimedia messaging (text and images) intervention. Message scheduling (2 days/week × 6 weeks) was based on the literature. Content was developed iteratively by the study team and focused on health harms and addictiveness of hookah. Content was individually tailored by baseline hookah use frequency, risk beliefs, and responses to interactive text messages assessing participants' hookah tobacco use behavior and beliefs to maximize impact. Engagement was assessed during the intervention, and we examined effects on risk perceptions, risk beliefs, and risk appraisals, motivation to quit, and behavior change immediately post-intervention.
Results


Participants responded to 11.5 (SD = 0.69) of 12 text message prompts on average, endorsed high message receptivity (M = 6.1, SD = 0.93, range = 1-7), and reported the messages were helpful (M = 8.5, SD = 1.5, range = 1-10). There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention. Half of participants reported reducing frequency of hookah use (20%) or quitting completely (30%) by end of treatment.
Conclusions


These pilot results provide preliminary support for an mHealth messaging intervention about risks of hookah tobacco for promoting cessation. Rigorously examining the efficacy of this promising intervention is warranted.",2020,"There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention.","['young adult hookah smokers', 'young adults', 'Young Adults', 'Methods\n\n\nYoung adults (N\u2009=\u200920) aged 18 to 30\u2009years who smoke hookah at least monthly and have done so at least once in the past 30\u2009days received a']","['mobile messaging', '6-week mHealth multimedia messaging (text and images) intervention', 'Mobile Messaging Intervention']","['risk appraisals', 'risk beliefs', 'motivation to quit', 'risk perceptions, risk beliefs, and risk appraisals, motivation to quit, and behavior change immediately post-intervention', 'frequency of hookah use', 'risk perceptions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.17273,"There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention.","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Snow', 'Affiliation': 'Department of Human Science, School of Nursing and Health Studies, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': 'Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}]",Tobacco use insights,['10.1177/1179173X20915200']
1910,30575473,Radical Prostatectomy or Watchful Waiting in Prostate Cancer - 29-Year Follow-up.,"BACKGROUND


Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term follow-up is sparse.
METHODS


We randomly assigned 695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017. Cumulative incidence and relative risks with 95% confidence intervals for death from any cause, death from prostate cancer, and metastasis were estimated in intention-to-treat and per-protocol analyses, and numbers of years of life gained were estimated. We evaluated the prognostic value of histopathological measures with a Cox proportional-hazards model.
RESULTS


By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001; absolute difference in risk, 11.7 percentage points; 95% CI, 5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
CONCLUSIONS


Men with clinically detected, localized prostate cancer and a long life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained. A high Gleason score and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death from prostate cancer. (Funded by the Swedish Cancer Society and others.).",2018,"Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
","['695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017', 'men with clinically detected localized prostate cancer', 'Men with clinically detected, localized prostate cancer', 'By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had']","['Radical prostatectomy', 'Radical Prostatectomy or Watchful Waiting', 'radical prostatectomy', 'radical prostatectomy, extracapsular extension']","['Cumulative incidence and relative risks', 'risk of death from prostate cancer', 'died; 71 deaths']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",695.0,0.117986,"Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bill-Axelson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Garmo', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Busch', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Nordling', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Häggman', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Swen-Olof', 'Initials': 'SO', 'LastName': 'Andersson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andrén', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Hans-Olov', 'Initials': 'HO', 'LastName': 'Adami', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Johansson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}]",The New England journal of medicine,['10.1056/NEJMoa1807801']
1911,32440294,"Letter to the Editor on ""Analgesic Effects of Ketamine, Magnesium Sulfate, and Sodium-Thiopental on Propofol Injection Pain: A Single-Blind Randomized Clinical Trial"".",,2019,,[],"['Ketamine, Magnesium Sulfate, and Sodium-Thiopental']",['Propofol Injection Pain'],[],"[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C4282968', 'cui_str': 'Propofol Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0994096,,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Aminnejad', 'Affiliation': 'Department of Anesthesiology & Critical Care, Qom University of Medical Sciences, Qom, Iran, Department of Pain Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Tanaffos,[]
1912,32440267,A comparative study of sequential vs. simultaneous type I tympanoplasty in patients with bilateral chronic otitis media - Mucosal type.,"Background


Patients with bilateral chronic otitis media - mucosal type have been conventionally treated with sequential tympanoplasty. Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss. With the advent of modern surgical instruments and surgical techniques, the risk is expected to be lower. This study compares the clinical outcomes in type I tympanoplasty performed simultaneously and sequentially.
Materials & methods


This randomized prospective study was carried out in a tertiary care hospital between August 2015 and July 2017. A total of 30 patients were divided into two groups of 15 each. This study analyzed the graft uptake, pure tone audiogram findings pre- and post-operatively, duration of surgery and number of hospital visit for each patient and the outcomes were compared between both the groups.
Result


Patients undergoing bilateral simultaneous tympanoplasty had significantly lesser mean duration of surgery and number of hospital visits than the patients undergoing sequential tympanoplasty. Graft uptake and postoperative wound infections were similar in both the groups. Postoperative hearing improvement was significantly better in the bilateral simultaneous tympanoplasty group. However, further studies are needed to authenticate this observation. None of the patients had a postoperative deterioration of hearing or sensorineural hearing loss.
Conclusion


Bilateral simultaneous tympanoplasty is not only feasible but also better than sequential tympanoplasty, especially in terms of operating time, follow-up and overall financial implications on the patient.",2020,Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss.,"['\n\n\nPatients with bilateral chronic otitis media - mucosal type', 'patients with bilateral chronic otitis media - Mucosal type', '30 patients', 'tertiary care hospital between August 2015 and July 2017']",['sequential vs. simultaneous type I tympanoplasty'],"['Graft uptake and postoperative wound infections', 'postoperative deterioration of hearing or sensorineural hearing loss', 'Postoperative hearing improvement', 'mean duration of surgery and number of hospital visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",30.0,0.0251294,Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss.,"[{'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Umamaheswaran', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Panimalar Medical College Hospital & Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Department of ENT, Head & Neck Surgery, MGM Healthcare, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vinoth', 'Initials': 'V', 'LastName': 'Manimaran', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Sri Ramachandra Institute of Higher Education & Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sathishkumar', 'Initials': 'S', 'LastName': 'Jayagandhi', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Sri Ramachandra Institute of Higher Education & Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shiva Priya', 'Initials': 'SP', 'LastName': 'Jeyabalakrishnan', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Karpagam Faculty of Medical Sciences & Research, Coimbatore, Tamil Nadu, India.'}]",Journal of otology,['10.1016/j.joto.2019.12.005']
1913,32440610,Pain inhibition is not affected by exercise-induced pain.,"Introduction


Offset analgesia (OA) and conditioned pain modulation (CPM) are frequently used paradigms to assess the descending pain modulation system. Recently, it was shown that both paradigms are reduced in chronic pain, but the influence of acute pain has not yet been adequately examined.
Objectives


The aim of this study is to investigate OA and CPM after exercise-induced pain to evaluate whether these tests can be influenced by delayed-onset muscle soreness (DOMS) at a local or remote body site.
Methods


Forty-two healthy adults were invited to 3 separate examination days: a baseline appointment, the consecutive day, and 7 days later. Participants were randomly divided into a rest (n = 21) and an exercise group (n = 21). The latter performed a single intensive exercise for the lower back. Before, immediately after, and on the following examination days, OA and CPM were measured at the forearm and the lower back by blinded assessor.
Results


The exercise provoked a moderate pain perception and a mild delayed-onset muscle soreness on the following day. Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
Conclusion


Delayed-onset muscle soreness was shown to have no effect on the inhibitory pain modulation system neither locally (at the painful body part), nor remotely. Thus, OA and CPM are robust test paradigms that probably require more intense, different, or prolonged pain to be modulated.",2020,"Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
",['Methods\n\n\nForty-two healthy adults'],"['exercise group', 'Introduction\n\n\nOffset analgesia (OA) and conditioned pain modulation (CPM']","['moderate pain perception', 'OA and CPM', 'chronic pain', 'Pain inhibition']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",42.0,0.0707934,"Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
","[{'ForeName': 'Tibor M', 'Initials': 'TM', 'LastName': 'Szikszay', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Waclaw M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wojtyna', 'Affiliation': 'Institute of Psychology, University of Silesia, Katowice, Katowice, Poland.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}]",Pain reports,['10.1097/PR9.0000000000000817']
1914,32440337,Efficacy of L-carnitine and propranolol in the management of acute theophylline toxicity.,"Theophylline toxicity results in substantial morbidity and mortality particularly due to its narrow therapeutic index. The development of new treatments for acute theophylline toxicity is a point of research interest. The aim of the present work was to assess the efficacy of L-carnitine (LC) and propranolol in the management of patients with acute theophylline toxicity. The study was conducted on 60 patients with acute theophylline toxicity admitted to the Poison Control Center or Intensive Care Unit at Alexandria Main University Hospital. The studied patients were equally classified into four groups (GPs, 15 patients each): the first group was the control group who received standard treatment protocol for theophylline toxicity. The other three GPs also received standard treatment protocol for theophylline toxicity in addition. The second group (LC group) received LC with a loading dose of 100 mg/kg IV over 30-60 min (maximum 6 g) and the maintenance dose was 50 mg/kg IV every 8 h. The third group (propranolol group) received propranolol, administered slowly intravenous 0.5-1 mg over 1 min; it may be repeated if necessary up to a total maximum dose of 0.1 mg/kg. The fourth group (propranolol and LC) received both IV propranolol and LC in the same doses as previous. Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings. Although combined therapy yields the best results and outcome, LC can serve as an antidote for acute theophylline toxicity if there is any contraindication to propranolol administration.",2020,Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings.,"['patients with acute theophylline toxicity', '60 patients with acute theophylline toxicity admitted to the Poison Control Center or Intensive Care Unit at Alexandria Main University Hospital']","['propranolol and LC', 'Theophylline toxicity', 'L-carnitine and propranolol', 'standard treatment protocol for theophylline toxicity', 'LC', 'L-carnitine (LC) and propranolol', 'propranolol']",['acute theophylline toxicity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032340', 'cui_str': 'Centers, Poison Control'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}]",60.0,0.0141716,Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings.,"[{'ForeName': 'Naima A', 'Initials': 'NA', 'LastName': 'Sherif', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Asmaa S', 'Initials': 'AS', 'LastName': 'El-Banna', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Marwan M', 'Initials': 'MM', 'LastName': 'ElBourini', 'Affiliation': 'Critical Care Medicine, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Nancy O', 'Initials': 'NO', 'LastName': 'Khalil', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}]",Toxicology research,['10.1093/toxres/tfaa002']
1915,32440409,Does Realism Matter? A Randomized Controlled Trial Comparing Models for Medical Student Suture Education.,"Background


We hypothesized that medical students trained in suturing using high-fidelity models (cadaveric tissue) would demonstrate greater proficiency when compared with those trained using low-fidelity models (synthetic tissue).
Methods


Forty-three medical students were randomized into 2 groups. Group 1 consisted of students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue. Suturing proficiency was measured pre- and postinstruction using the Global Rating Scale and by measuring suture accuracy. Perceived confidence in suturing was measured on a scale of 0-100.
Results


Perceived confidence was measured as an average of 8.26 out of 100 pretraining and significantly improved after training (56.91 out of 100); however, there was no significant difference when comparing confidence between groups posttraining (57.65 cadaveric versus 56.05 synthetic;  P  = 0.78), nor in the measured confidence change pre- and posttraining ( P  = 0.53). Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48). The change in adequate suture placement pre- and posttraining did not reach statistical significance between groups ( P  = 0.27). After instruction, participants demonstrated a significant improvement in total suture performance scores; however, there was no significant difference when comparing groups (30.04 cadaveric versus 29.80 synthetic;  P  = 0.90), nor in the total change pre- and posttraining ( P  = 0.74).
Conclusions


Training medium fidelity (tissue versus synthetic) does not significantly influence a student's overall suturing performance. However, formal instruction significantly improves objective competence and perceived confidence. Regardless of the model, surgical departments should emphasize medical student exposure to basic surgical skills education.",2020,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","['Methods\n\n\nForty-three medical students', 'Medical Student Suture Education']","['students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue']","['Global Rating Scale', 'Perceived confidence in suturing', 'total suture performance scores', 'objective competence and perceived confidence', 'number of adequately placed sutures']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",100.0,0.0412224,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","[{'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Blau', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Ronnie L', 'Initials': 'RL', 'LastName': 'Shammas', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Anolik', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Yash J', 'Initials': 'YJ', 'LastName': 'Avashia', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Krucoff', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zenn', 'Affiliation': 'Zenn Plastic Surgery, Raleigh, N.C.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002738']
1916,32440592,"An Open-Label Feasibility Trial Examining the Effectiveness of a Cognitive Training Program, Goal Management Training, in Individuals With Posttraumatic Stress Disorder.","Background


Posttraumatic stress disorder (PTSD) is associated with dysfunction across multiple cognitive domains including executive functioning, attention, and verbal memory. This dysfunction is associated with negative impacts on functional outcomes (e.g., work or social functioning) and reduced response to psychotherapy for PTSD. Despite this knowledge, little work has investigated the efficacy of cognitive remediation strategies in improving cognition and functional outcomes among individuals with PTSD.
Objective


The current study investigated the efficacy of an established cognitive remediation program, Goal Management Training (GMT), in improving cognitive functioning in a pilot sample of individuals with PTSD symptoms in an inpatient treatment setting.
Method


Thirty-four inpatients with PTSD symptoms participated in either GMT in addition to treatment as usual (TAU; consisting of psychiatric management, group and individual psychotherapy) (TAU+GMT;  n  = 18) or TAU alone ( n =  16). The TAU+GMT group received neuropsychological assessment at baseline and posttreatment, while both the TAU+GMT and TAU groups received assessment with clinical self-report measures at baseline and posttreatment.
Results


Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group. Mixed-design analyses of variance (ANOVAs) revealed a trend toward an interaction effect indicating potentially greater improvements on a measure of the ability to engage in goal-directed behaviors while highly emotional in the TAU+GMT group as compared to the TAU group.
Discussion


The results of this small feasibility investigation of GMT in PTSD point toward the potential efficacy of GMT in ameliorating cognitive difficulties in individuals with PTSD.",2019,"Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group.","['\n\n\nPosttraumatic stress disorder (PTSD', 'Individuals With Posttraumatic Stress Disorder', 'individuals with PTSD', 'individuals with PTSD symptoms in an inpatient treatment setting', 'Method\n\n\nThirty-four inpatients with PTSD symptoms participated in either']","['Cognitive Training Program, Goal Management Training', 'usual (TAU; consisting of psychiatric management, group and individual psychotherapy) (TAU+GMT;  n \u2009=\u200918) or TAU alone', 'established cognitive remediation program, Goal Management Training (GMT', 'TAU+GMT and TAU', 'GMT', 'TAU+GMT']","['executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",34.0,0.0142751,"Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group.","[{'ForeName': 'Jenna E', 'Initials': 'JE', 'LastName': 'Boyd', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Homewood Research Institute, Guelph, Ontario, Canada.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Protopopescu', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jetly', 'Affiliation': 'Directorate of Mental Health, Canadian Forces Health Services Group Headquarters, Department of National Defence, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Rhind', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Ontario, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Lanius', 'Affiliation': 'Homewood Research Institute, Guelph, Ontario, Canada.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'McKinnon', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547019841599']
1917,32440303,Effect of Intermittent Subglottic Irrigation with 5% NaCl on the Prevention of Ventilator Associated Pneumonia in Critically Ill Patients.,"Background


Ventilator-Associated Pneumonia (VAP) is one of the common causes of mortality and morbidity. Subglottic secretion suction decreases the incidence of VAP. In this study, the effect of 5% sodium chloride (NaCl) in subglottic area in addition to secretion suction in VAP prevention was investigated in patients who were admitted to the intensive care unit.
Materials and Methods


All patients were intubated by an intubation tube with subglottic suction. In the intervention group, subglottic area was washed with 10 ml of  5%  sodium chloride solution, and in the control group the subglottic area was washed with 10 ml distilled water. Patients were monitored for a maximum of two weeks, and the incidence of VAP was monitored by a Clinical Pulmonary Infection Score (CPIS).
Results


There was no significant difference between the two groups in terms of age and sex. Four (27%) patients in the intervention group, and 7 (37%) in control group were diagnosed with VAP, which was not statistically significant between the two groups (P=0.225). The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
Conclusion


It was expected that in this study the rate of VAP became significantly lower with the intervention of using antimicrobial solution in addition to suction. Although the rate decreased clinically, it was not statistically significant, which may be due to the low number of patients.",2019,"The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
","['Critically Ill Patients', 'patients who were admitted to the intensive care unit']","['intubation tube with subglottic suction', 'Intermittent Subglottic Irrigation with 5% NaCl', 'sodium chloride solution', 'Subglottic secretion suction', '5% sodium chloride (NaCl']","['incidence of VAP', 'duration of hospitalization, duration of intubation and mortality', 'rate of VAP', 'Clinical Pulmonary Infection Score (CPIS']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0505448,"The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
","[{'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Naghibi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Mosavi Educational Hospital, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Mosavi Educational Hospital, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Somayae', 'Initials': 'S', 'LastName': 'Abdollahi Sabet', 'Affiliation': 'Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Dobakhti', 'Affiliation': 'School of Pharmacy, Zanjan University of Medical Science, Zanjan, Iran.'}]",Tanaffos,[]
1918,32440518,Cognitive behavioural therapy for insomnia reduces sleep apnoea severity: a randomised controlled trial.,"Insomnia and obstructive sleep apnoea (OSA) frequently co-occur and may be causally related through sleep fragmentation and/or hyperarousal mechanisms. Previous studies suggest that OSA treatment can improve insomnia severity. However, the effect of insomnia treatment on OSA severity has not been investigated. We performed a randomised controlled trial to investigate the effect of cognitive behavioural therapy for insomnia (CBTi) on OSA severity, controlling for potential sleep-stage and posture effects. 145 patients with comorbid insomnia (International Classification of Sleep Disorders, 3rd Edn) and untreated OSA (apnoea-hypopnoea index (AHI) ≥15 events·h -1  sleep) were randomised to a four-session CBTi programme or to a no-treatment control. Overnight sleep studies were completed pre- and post-treatment to measure AHI, arousal index and sleep architecture, to investigate the effect of intervention group, time, sleep stage (N1-3 or REM) and posture (supine or nonsupine) on OSA severity. The CBTi group showed a 7.5 event·h -1  greater AHI difference (mean (95% CI) decrease 5.5 (1.3-9.7) events·h -1 , Cohen's  d =0.2, from 36.4 events·h -1  pre-treatment) across sleep-stages and postures, compared to control (mean increase 2.0 (-2.0-6.1) events·h -1 ,  d =0.01, from 37.5 events·h -1  at pre-treatment; interaction p=0.012). Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture. CBTi consolidates sleep periods and promotes a 15% decrease in OSA severity in patients with comorbid insomnia and OSA. This suggests that insomnia disorder may exacerbate OSA and provides further support for treating insomnia in the presence of comorbid OSA.",2020,"Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture.","['145 patients with comorbid insomnia (International Classification of Sleep Disorders, 3rd Edn) and untreated OSA (apnoea-hypopnoea index (AHI) ≥15\u2005events·h -1  sleep', 'patients with comorbid insomnia and OSA']","['CBTi programme or to a no-treatment control', 'Cognitive behavioural therapy', 'cognitive behavioural therapy', 'OSA']","['OSA severity', 'insomnia severity', 'arousal index, or sleep architecture', 'Insomnia and obstructive sleep apnoea (OSA', 'sleep apnoea severity', 'total number', 'AHI, arousal index and sleep architecture', 'time, sleep stage (N1-3 or REM) and posture (supine or nonsupine) on OSA severity', 'duration of nocturnal awakenings']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]",145.0,0.0470048,"Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Eckert', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",ERJ open research,['10.1183/23120541.00161-2020']
1919,32440585,Reduction of Distress Intolerance With Salutotherapeutic Interventions: Results From a Randomized Controlled Clinical Trial.,"Background


Distress tolerance is the ability to pursue one's goals in the presence of (chronic) stressors, hardship, adversities and negative internal states, and psychological distress. By contrast, distress intolerance is a transdiagnostic indicator of mental illness and a mediator in coping with problems in life, work demands, or stress in general. There is a lack of data regarding intervention strategies. The objective of the present study is to test the differential effects of two treatment approaches: ""regeneration fostering"" versus ""resistance training.""
Methods


Inpatients of a psychosomatic hospital were randomly allocated to either a resistance training group therapy ( n  = 65)-that is, active coping with demands and endurance-or a regeneration fostering group therapy ( n  = 62)-that is, recovery, mindful indulgence, and creative activities. They were compared with a group of patients who received treatment as usual ( n  = 43), without special treatments for distress intolerance, and the outcome was measured with the ""Distress Intolerance Scale."" One-way and repeated measure analyses of variance and paired  t  tests were used for the analysis.
Results


The ""regeneration"" group showed a significant improvement in distress intolerance, whereas there was no significant change for the treatment-as-usual group and in the ""resistance"" group. Post hoc tests were conducted with paired sample  t  tests for pre-post comparisons for each group. No differences were found for the treatment-as-usual group ( mean difference : 0.03,  SD  (mean difference): 0.89;  t (42) = 0.266,  p  = 0.792,  d  = 0.04) and for the resistance group ( mean difference :-0.07,  SD  (mean difference): 0.73;  t (63) = -0.736,  p  = 0.464,  d  = 0.08). The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
Conclusions


In the treatment of distress intolerance, it seems promising to focus on positive psychology interventions and resources. Limitations of the study are that it was conducted with psychosomatic inpatients only and that no follow-up data are available.",2018,"The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
",['Methods\n\n\nInpatients of a psychosomatic hospital'],"['resistance training group therapy ( n \u2009=\u200965)-that is, active coping with demands and endurance-or a regeneration fostering group therapy', 'regeneration fostering"" versus ""resistance training', 'Salutotherapeutic Interventions']","['Distress Intolerance Scale', 'distress intolerance', 'Distress Intolerance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.119477,"The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': 'Research Group Psychosomatic Rehabilitation, Charié University Medicine, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Linden', 'Affiliation': 'Research Group Psychosomatic Rehabilitation, Charié University Medicine, Berlin, Germany.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547018800484']
1920,32440603,No Time-Dependent Effects of Psychosocial Stress on Fear Contextualization and Generalization: A Randomized-Controlled Study With Healthy Participants.,"The formation of context-dependent fear memories (fear contextualization) can aid the recognition of danger in new, similar, situations. Overgeneralization of fear is often seen as hallmark of anxiety and trauma-related disorders. In this randomized-controlled study, we investigated whether exposure to a psychosocial stressor influences retention of fear contextualization and generalization in a time-dependent manner. The Trier Social Stress Test was used to induce psychosocial stress. Healthy male participants (n = 117) were randomly divided into three experimental groups that were subjected to the acquisition phase of the Fear Generalization Task: (1) without stress, (2) immediately after acute stress, or (3) 2 h after acute stress. In this task, a male with neutral facial expression (conditioned stimuli) was depicted in two different contexts that modulated the conditioned stimuli-unconditioned stimuli (=shock) association (threat, safe). Salivary alpha-amylase and cortisol levels were measured throughout the experiment. After a 24-h delay, context-dependency of fear memory was investigated with an unannounced memory test consisting of the threat and safe contexts alternated with a novel context (the generalization context). Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization. Directly after acquisition, there were no time-dependent effects of psychosocial stress on fear contextualization. Context-dependency of fear memories was retained 24 h later, as fear-potentiated startle responding was modulated by context (threat > safe or novel). At that time, the context-dependency of fear memories was also not influenced by the early or late effects of the endogenous stress response during acquisition. These results with experimental stress deviate in some aspects from those earlier obtained with exogenous hydrocortisone administration, suggesting a distinct role for stress mediators other than cortisol.",2019,"Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization.","['male with neutral facial expression (conditioned stimuli', 'Healthy Participants', 'Healthy male participants (n\u2009=\u2009117']",['hydrocortisone'],"['Fear Contextualization and Generalization', 'fear-potentiated startle responses', 'Salivary alpha-amylase and cortisol levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}, {'cui': 'C0038186', 'cui_str': 'Startle Reaction'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",117.0,0.0146613,"Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization.","[{'ForeName': 'Milou S C', 'Initials': 'MSC', 'LastName': 'Sep', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Gorter', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'van Ast', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Joëls', 'Affiliation': 'Department of Translational Neuroscience, UMC Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Elbert', 'Initials': 'E', 'LastName': 'Geuze', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547019896547']
1921,32441171,Influence of Different Rehydration Protocols on Biomechanical Properties of Allogeneic Cortical Bone Plates: A Combined  in-vitro / in-vivo  Study.,"Introduction:  Allogeneic cortical bone plates (CP) are used for alveolar ridge augmentation. Since CP are freeze-dried and dehydrated during processing, the breaking strength (BS) and the flexibility (FX) are reduced, resulting in a relevant risk for plate fractures during insertion. The aim of this study was to evaluate the influence of rehydration time on the biomechanical properties (BS & FX) of CP  in-vitro  and  in vivo . Material and Methods:  40 CP were randomly divided into four experimental groups. (A) untreated control (n = 10), rehydration for 10 (B), 30 (C) and 60 (D) minutes in 0.9% saline solution (n = 10 each). BS [Newton, N] and FX [mm] (force till fracture and distance of deflection to the breaking point) were analyzed. Besides, architectural features of all CP groups were visualized and examined by scanning electron microscopy (SEM). In addition, the frequency of CP fractures of rehydrated- vs. non-rehydrated CP was retrospectively analyzed in 6 patients. Results:  Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035). After a rehydration time of 10 minutes, no additional increase of BS and FX was seen when compared to30 and 60 minutes (p each = 1.0). SEM scans demonstrated that the CP fracture characteristics were influenced by the different rehydration protocols. The frequency of CP fractures was reduced in patients by CP rehydration. Conclusion:  The biomechanical properties of CP can be significantly improved by 10 min of rehydration, resulting in an increased BS and FX, that might be clinically relevant.",2020,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).",['40 CP'],['Allogeneic cortical bone plates (CP'],"['CP fracture characteristics', 'BS and FX', 'breaking strength (BS) and the flexibility (FX', 'frequency of CP fractures', 'Biomechanical Properties of Allogeneic Cortical Bone Plates']",[],"[{'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]",,0.0180156,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pabst', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, Federal Armed Forces Hospital, Koblenz, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ackermann', 'Affiliation': 'Institute of Functional and Clinical Anatomy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thiem', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1767735']
1922,32440640,A comparative study on efficacy of fixed combination timolol/brinzolamide versus travoprost monotherapy in drug-naïve open-angle glaucoma patients.,"Background


Glaucoma is most common irreversible cause of blindness in India. First line management of open-angle glaucoma is either beta blockers or prostaglandin analogs monotherapy. Monotherapy rarely achieves target intraocular pressure within 2 years and patients are shifted to combination medications, usually fixed-dose combination.
Objective


To compare travoprost monotherapy and timolol/brinzolamide fixed-dose combination for their intraocular pressure lowering efficacy, their effects on hemodynamic parameters and cup disc ratio reversibility in newly diagnosed drug-naïve open-angle glaucoma patients.
Material and methods


In a 12-week, prospective, randomised, single-blind study, patients were randomised to receive twice daily 0.5% timolol and 0.2% brinzolamide fixed-dose combination (n = 52) or once daily travoprost 0.004% (n = 52). Intraocular pressure, blood pressure, pulse rate and cup disc ratio were compared across treatment groups over 3 months.
Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively. Significant changes in pulse rate (9 beats/min) and systolic blood pressure (2.35 mmHg) was observed in fixed-dose combination group. No cup disc ratio reversibility was observed at the end of study. Conjunctival hyperaemia ( n  = 14) and transient blurring of vision ( n  = 16) were most commonly reported adverse drug reaction in monotherapy and fixed-dose combination, respectively.
Conclusion


The 0.5% timolol and 0.2% brinzolamide fixed-dose combination produced greater reduction in intraocular pressure than those produced by 0.004% travoprost alone in drug-naïve open-angle glaucoma patients.",2020,"Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively.","['drug-naïve open-angle glaucoma patients', 'newly diagnosed drug-naïve open-angle glaucoma patients']","['Monotherapy', 'timolol/brinzolamide fixed-dose combination', 'prostaglandin analogs monotherapy', 'timolol and 0.2% brinzolamide fixed-dose combination', 'timolol', 'fixed combination timolol/brinzolamide versus travoprost monotherapy']","['hemodynamic parameters and cup disc ratio reversibility', 'Intraocular pressure, blood pressure, pulse rate and cup disc ratio', 'transient blurring of vision', 'pulse rate', 'adverse drug reaction', 'Conjunctival hyperaemia', 'systolic blood pressure', 'cup disc ratio reversibility', 'intraocular pressure']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C3653114', 'cui_str': 'timolol, combinations'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.186782,"Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively.","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Ashish', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai 206130, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Ophthalmology, Uttar Pradesh University of Medical Sciences, Saifai, India.'}]",Therapeutic advances in ophthalmology,['10.1177/2515841420909666']
1923,32440646,Uncommitted Commitment: Behavioral Strategy to Prevent Preference Reversals.,"When both smaller-sooner (SS) and larger-later (LL) rewards are temporally distal, individuals frequently prefer the LL. However, because both outcomes become proximal, individuals frequently switch to preferring the SS. These preference reversals are predicted by hyperbolic delay discounting, and may model the essential challenge of self-control. Using smokers, a population known to have high rates of delay discounting, and thus more vulnerable to preference reversals, this pilot study sought to examine  soft commitment  as a strategy that may prevent preference reversals. Eleven smokers were assigned to an experimental commitment condition, operationalized as 3 weeks of daily commitment trials indicating preference between an SS and LL. Ten smokers were assigned to a control commitment condition. These 3 weeks were followed by 8 days of daily choice trials indicating preference between an impending SS and LL, for both experimental and control conditions. Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group. This pilot study provides an initial indication that soft commitment can facilitate choice persistence and prevent preference reversals.",2020,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.",['Eleven smokers'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],11.0,0.0233431,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milhorn', 'Affiliation': '2University of Maryland, College Park, MD USA.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Kayla N', 'Initials': 'KN', 'LastName': 'Tormohlen', 'Affiliation': '3Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD USA.'}, {'ForeName': 'Jama', 'Initials': 'J', 'LastName': 'Bettis', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}]",Perspectives on behavior science,['10.1007/s40614-019-00229-8']
1924,31464821,Management of Prenatal Depression: Effectiveness of an Online Training Module Across Health Care Disciplines.,"INTRODUCTION


Maternal depression is associated with numerous deleterious maternal and child health outcomes. Although there are several treatment options for prenatal depression, many depressed women remain untreated. This study tested the effects of a low-intensity online training module on providers' attitudes, beliefs, and management practices of prenatal depression across a diverse group of providers.
METHODS


Health care providers who were providing care to pregnant women completed a 64-item survey consisting of items from the Management of Maternal Depression Inventory. Upon completion of the survey, providers were randomized into the intervention or the active control arm (wait-listed). The intervention consisted of an online training, which targeted knowledge and skills related to providing guidance on prenatal mood disorders. Approximately 6 to 8 weeks after randomization, all providers completed the survey again, and a general linear model framework was used to test change from baseline.
RESULTS


The final sample was comprised 74 compliant providers (intervention arm: n = 41; control arm: n = 33). Providers in the intervention arm reported significant increases in the sense of responsibility and self-efficacy when compared with their counterparts in the active control arm (all P < .001). Providers in the intervention arm also reported an increase in satisfaction related to communication with mental health specialists when compared with their counterparts in the active control arm (P = .05).
DISCUSSION


Our findings suggest that a brief, online training improved the attitudes, confidence, and communication of diverse providers related to the management of prenatal depression. Provider online training may help encourage patient-provider dialogue and in turn, enhance the management of prenatal depression.",2019,"Providers in the intervention arm also reported an increase in satisfaction related to communication with mental health specialists when compared with their counterparts in the active control arm (P = .05).
","['Across Health Care Disciplines', ""providers' attitudes, beliefs, and management practices of prenatal depression across a diverse group of providers"", '74 compliant providers (intervention arm: n = 41; control arm: n = 33', 'Health care providers who were providing care to pregnant women completed a 64-item survey consisting of items from the Management of Maternal Depression Inventory']","['low-intensity online training module', 'Provider online training', 'online training', 'Online Training Module']","['satisfaction related to communication with mental health specialists', 'sense of responsibility and self-efficacy']","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",74.0,0.041574,"Providers in the intervention arm also reported an increase in satisfaction related to communication with mental health specialists when compared with their counterparts in the active control arm (P = .05).
","[{'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'A Leiferman', 'Affiliation': 'Dr. Leiferman: Associate Professor, Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, CO. Dr. Farewell: Senior Research Instructor, Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, CO. Dr. Lee-Winn: Assistant Professor, Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, CO. Ms. Jewell: DrPH Student, Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, CO. Ms. Ulrickson: Research Coordinator, Denver Health and Hospital Authority, Denver, CO. Dr. Huberty: Associate Professor, Arizona State University, Phoenix, AZ. Dr. Paulson: Associate Professor Old Dominion University, Norfolk, VA.'}, {'ForeName': 'Charlotte V', 'Initials': 'CV', 'LastName': 'Farewell', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'E Lee-Winn', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jewell', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ulrickson', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paulson', 'Affiliation': ''}]",The Journal of continuing education in the health professions,['10.1097/CEH.0000000000000263']
1925,11099394,Conjugated linoleic acid induces lipid peroxidation in men with abdominal obesity.,"Conjugated linoleic acid (CLA) has been shown in experimental studies to have chemoprotective properties, and may decrease the deposition of body fat. CLA is prone to oxidation, and it has been suggested that increased lipid oxidation may contribute to the anti-tumorigenic effects of this agent. The present study investigates the urinary levels of 8-iso-prostaglandin F(2alpha) (8-iso-PGF(2alpha)), a major isoprostane, and of 15-oxo-dihydro-PGF(2alpha), a major metabolite of PGF(2alpha), as indicators of non-enzymic and enzymic arachidonic acid oxidation respectively after dietary supplementation with CLA in middle-aged men (mean age 53 years) with abdominal obesity for 1 month in a randomized controlled trial. Significant increases in the levels of both 8-iso-PGF(2alpha) and 15-oxo-dihydro-PGF(2alpha) in urine (P<0. 0001 and P=0.0013 respectively) were observed after 1 month of daily CLA intake (4.2 g/day) as compared with the control group. The lipid peroxidation parameters had returned to their basal levels at 2 weeks after the cessation of CLA intake, and remained at the same levels for a further 2 weeks until the end of the study. CLA had no effect on serum alpha-tocopherol and gamma-tocopherol levels, or on the urinary levels of 2,3-dinor-thromboxane B(2). Thus CLA may induce both non-enzymic and enzymic lipid peroxidation in vivo in middle-aged men with abdominal obesity, without any side effects. The consequences of the increased lipid peroxidation after CLA supplementation are unknown.",2000,"CLA had no effect on serum alpha-tocopherol and gamma-tocopherol levels, or on the urinary levels of 2,3-dinor-thromboxane B(2).","['middle-aged men with abdominal obesity', 'men with abdominal obesity', 'middle-aged men (mean age 53 years) with abdominal obesity for 1 month']","['Conjugated linoleic acid', 'CLA', 'dietary supplementation with CLA', 'Conjugated linoleic acid (CLA']","['serum alpha-tocopherol and gamma-tocopherol levels, or on the urinary levels of 2,3-dinor-thromboxane B(2', 'levels of both 8-iso-PGF(2alpha) and 15-oxo-dihydro-PGF(2alpha', 'lipid peroxidation parameters', 'urinary levels of 8-iso-prostaglandin F(2alpha', 'lipid peroxidation']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1257880', 'cui_str': 'Linoleic Acids, Conjugated'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0969677', 'cui_str': 'd-alpha tocopherol'}, {'cui': 'C0017054', 'cui_str': '3,4-Dihydro-2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)-2H-1-benzopyran-6-ol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0255663', 'cui_str': 'S-(2-(N,N-diisopropylamino)ethyl)isothiourea'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C1528569', 'cui_str': '8-isoprostaglandin PGF2beta'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}]",,0.0379771,"CLA had no effect on serum alpha-tocopherol and gamma-tocopherol levels, or on the urinary levels of 2,3-dinor-thromboxane B(2).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Sections of Geriatrics and Clinical Nutrition Research, Faculty of Medicine, Uppsala University, Box 609, SE-751 25 Uppsala, Sweden. samar.basu@geriatrik.uu.se'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Turpeinen', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vessby', 'Affiliation': ''}]","Clinical science (London, England : 1979)",['10.1042/cs0990511']
1926,32440638,"Anemia and Micronutrient Status during Pregnancy, and Their Associations with Obstetric and Infant Outcomes among HIV-Infected Ugandan Women Receiving Antiretroviral Therapy.","Background


Women living with HIV (WLHIV) are at higher risk of micronutrient deficiencies and adverse health outcomes. There are limited data on the burden or sequelae of micronutrient deficiencies among pregnant WLHIV receiving antiretroviral therapy (ART).
Objectives


We aimed to examine anemia and vitamin B-12, folate, and vitamin D deficiencies, and their associations with obstetric and infant outcomes, among pregnant WLHIV initiating combination antiretroviral therapy (cART) in rural Uganda.
Methods


This was a prospective analysis among pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs), a randomized trial comparing the effects of protease inhibitor (PI)-based ART with those of a non-PI-based ART on placental malaria risk. We conducted a substudy on the burden of anemia [trimester 1/3: hemoglobin (Hb) <11.0 g/dL; trimester 2: Hb <10.5 g/dL;  n  = 367] and micronutrient deficiencies ( n  = 127) in pregnant WLHIV and their associations with obstetric and infant outcomes. Hb was measured by cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D was measured by ELISA. Linear and binomial regression were used to evaluate associations between micronutrient status during pregnancy and perinatal outcomes.
Results


26.8% women were anemic, 30.2% were vitamin B-12 insufficient (<221.0 pmol/L), 66.1% were folate insufficient (<13.5 nmol/L), and 65.4% were vitamin D insufficient (<30.0 ng/mL) at enrollment. Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001). Multivariate models showed that increased vitamin D concentrations predicted lower risk of infant wasting (WLZ < -2; RR: 0.94; 95% CI: 0.89, 0.99;  P  = 0.04). Multivariate models also indicated that maternal vitamin B-12 and folate concentrations at enrollment predicted maternal ( P  < 0.001) and infant ( P  = 0.02) concentrations postpartum.
Conclusions


Anemia and micronutrient deficiencies are associated with a variety of adverse obstetric and infant outcomes and are an important public health concern in perinatal WLHIV on cART and their children.This trial was registered at clinicaltrials.gov as NCT00993031.",2020,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","['anemia [trimester 1/3: hemoglobin (Hb)\xa0<11.0 g/dL; trimester 2', 'pregnant WLHIV receiving antiretroviral therapy (ART', 'pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs', 'HIV-Infected Ugandan Women Receiving Antiretroviral Therapy', '\n\n\nWomen living with HIV (WLHIV']","['protease inhibitor (PI)-based ART with those of a non-PI-based ART', 'pregnant WLHIV initiating combination antiretroviral therapy (cART']","['cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D', 'maternal vitamin B-12 and folate concentrations', 'Anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0056663', 'cui_str': 'Cyanmethemoglobin'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",367.0,0.327726,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Herman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Plenty', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': ""Division of Infectious Disease, Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sera L', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Department of Anthropology and Global Health Studies, Northwestern University, Evanston, IL, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa075']
1927,10657266,Effects of insulin on the cardiac autonomic nervous system in insulin-resistant states.,"The effects of insulin infusion on cardiac autonomic nervous system (ANS) activity were investigated in healthy subjects (n=15) and in patients with various types of insulin-resistance, such as obese subjects (n=20) and those with hypertension (n=15) or type II (non-insulin-dependent) diabetes (n=22). Healthy subjects and patients underwent euglycaemic hyperinsulinaemic glucose clamp, and cardiac ANS and haemodynamic changes were investigated by continuous recording of heart rate variability by the Holter technique and by venous occlusion plethysmography respectively. At baseline, healthy subjects had the highest values for total spectral power and the low-frequency (LF) component, and the lowest value for the high-frequency (HF) component. In the pooled data (n=72), the fasting plasma insulin concentration was correlated with baseline total spectral power (r=-0.37; P<0.001) and the LF/HF ratio (r=-0. 35; P<0.003). Such correlations were still significant (P<0.01 for both) after adjustment for body fat and mean arterial blood pressure. In a multivariate linear stepwise analysis (n=72), a model including body fat, waist/hip ratio, fasting plasma glucose concentration and insulin-mediated glucose uptake explained 47% of the variability of the change in the LF/HF ratio, with body fat (t=-3.11; P<0.01) and insulin-mediated glucose uptake (t=-3.48; P<0. 008) being significantly and independently associated with insulin-mediated changes in the LF/HF ratio. Insulin infusion reduced the total spectral power and increased the LF/HF ratio in healthy subjects, but not in insulin-resistant patients. In conclusion, our study demonstrates that insulin fails to stimulate cardiac ANS activity in insulin-resistant patients, independently of the causes of insulin resistance.",2000,"Insulin infusion reduced the total spectral power and increased the LF/HF ratio in healthy subjects, but not in insulin-resistant patients.","['healthy subjects (n=15) and in patients with various types of insulin-resistance, such as obese subjects (n=20) and those with hypertension (n=15) or type II (non-insulin-dependent) diabetes (n=22', 'insulin-resistant states', 'Healthy subjects and patients underwent']","['Insulin infusion', 'insulin infusion', 'euglycaemic hyperinsulinaemic glucose clamp', 'insulin']","['body fat and mean arterial blood pressure', 'total spectral power', 'LF/HF ratio', 'total spectral power and the low-frequency (LF) component', 'fasting plasma insulin concentration', 'cardiac autonomic nervous system (ANS) activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0380096,"Insulin infusion reduced the total spectral power and increased the LF/HF ratio in healthy subjects, but not in insulin-resistant patients.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': 'Department of Geriatric Medicine and Metabolic Diseases, II University of Naples, Naples, Italy. gpaoliss@tin.it'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Manzella', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rizzo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Varricchio', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gambardella', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Varricchio', 'Affiliation': ''}]","Clinical science (London, England : 1979)",['10.1042/cs0980129']
1928,32440639,Findings of a Pilot Study Investigating the Effects of Mediterranean Diet and Aerobic Exercise on Cognition in Cognitively Healthy Older People Living Independently within Aged-Care Facilities: The Lifestyle Intervention in Independent Living Aged Care (LIILAC) Study.,"Background


Cognitive decline and Alzheimer disease are more prevalent in our aging population. Modifiable risk factors, such as diet and sedentary lifestyle, have been proposed as key to potentially ameliorating cognitive decline. Both exercise and Mediterranean diet (MedDiet) have been linked to reduced levels of cardiovascular disease and other comorbidities. Higher levels of exercise and MedDiet adherence may prove to be cognitively protective, both individually and synergistically.
Objectives


The aim was to investigate the effect of a 6-mo program of MedDiet, exercise, and a combination of both, on cognition, mood, and general health in older persons living independently in aged-care communities.
Methods


The Lifestyle Intervention in Independent Living Aged Care (LIILAC) Study (ACTRN12614001133628) involved 102 participants, aged 60-90 y, who were randomly assigned to 1 of 4 intervention groups. Change in overall memory performance was assessed as the primary outcome. Additionally, changes in cognitive task performance, as well as mood, wellness, cardiovascular function, and blood biomarkers, were investigated.
Results


While there was no significant change in overall memory performance, there was a significant improvement in spatial working memory performance in the combined exercise and diet group, relative to controls. This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
Conclusions


This research indicates that diet and exercise programs have the potential to improve aspects of cognition and mood in an aging population. However, given the lower than optimal sample size and lack of resources to reinforce the interventions during the trial, further larger randomized controlled trials are required to substantiate whether the introduction of diet and exercise programs into independent-living facilities is a viable method to preserve cognitive health in older people. This trial was registered at www.ANZCTR.org.au ACTRN 12614001133628 (LIILAC Study).",2020,"This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
","['older persons living independently in aged-care communities', 'older people', 'Cognitively', '102 participants, aged 60-90 y', 'Healthy Older People Living']","['Lifestyle Intervention', 'exercise and Mediterranean diet (MedDiet', 'Mediterranean Diet and Aerobic Exercise']","['Depression Anxiety Stress Scale', 'overall memory performance', 'cognitive task performance, as well as mood, wellness, cardiovascular function, and blood biomarkers', 'spatial working memory performance', 'overall improvement in their emotional state']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0303596', 'cui_str': 'Yttrium-90'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",102.0,0.0557553,"This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
","[{'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Hardman', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Meyer', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Macpherson', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}]",Current developments in nutrition,['10.1093/cdn/nzaa077']
1929,32440753,The impact of reimbursement negotiations on cost and availability of new pharmaceuticals: evidence from an online experiment.,"BACKGROUND


The necessity to measure and reward ""value for money"" of new pharmaceuticals has become central in health policy debates, as much as the requirement to assess the ""willingness to pay"" for an additional, quality-adjusted life year (QALY). There is a clear need to understand the capacity of ""value-based"" pricing policies to impact societal goals, like timely access to new treatments, sustainable health budgets, or incentivizing research to improve patient outcomes. Not only the pricing mechanics, but also the process of value assessment and price negotiation are subject to reform demands. This study assesses the impact of a negotiation situation for life-extending pharmaceuticals on societal outcomes. Of interest were general effects of the bargaining behaviour, as well as differences caused by the assigned role and the magnitude of prices.
METHODS


We ran an online experiment (n = 404) on Amazon Mechanical Turk (MTurk). Participants were randomly assigned into four treatment groups for a reimbursement negotiation between two roles (health minister, pharma representative) in two price framings. Payoff to players consisted of a fixed salary and a potential bonus, depending on their preferences, their price offer and the counter offer of a randomly paired negotiation partner. Success had real social consequences on other MTurk users (premium payers, investors) and via donations to a patient association.
RESULTS


Margins between reservation prices and price offers increased throughout the game. Yet, 47% of players reduced at least once and 15% always their bonus probability to zero in favour of an agreement. 61% of simulated negotiation pairs could have reached an agreement, based on their preferences. 63% of these were successful, leaving 61% of patients with no access to the new treatment. The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group. The successful markets redistributed 20% of total assets from premium payers to investors over five innovation cycles.
CONCLUSIONS


The negotiation situation for pharmaceutical reimbursement has notable impact on societal outcomes. Further research should evaluate policies that align preferences and increase negotiation success.",2020,"The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group.",[],['Amazon Mechanical Turk (MTurk'],['real social consequences'],[],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.0286289,"The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group.","[{'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wettstein', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Frohburgstrasse 3, P.O. Box 4466, CH-6002, Lucerne, Switzerland. dominik.wettstein@stud.unilu.ch.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Boes', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Frohburgstrasse 3, P.O. Box 4466, CH-6002, Lucerne, Switzerland.'}]",Health economics review,['10.1186/s13561-020-00267-y']
1930,31392822,Dulaglutide is an effective treatment for lowering HbA1c in patients with type 2 diabetes regardless of body mass index.,"AIM


To assess the relationship between baseline body mass index (BMI) and glycaemic control in dulaglutide-treated patients, a post hoc analysis was conducted on HbA1c and baseline BMI data from eight AWARD studies, with a total of 5770 patients.
MATERIALS AND METHODS


Changes from baseline in HbA1c data from patients treated with 1.5 mg or 0.75 mg dulaglutide, active comparator or placebo, were analyzed in each study (AWARD-1 to -6, -8 and - 9) at approximately 6 months (26, 24 and 28 weeks, respectively). Within each study, data were analyzed by the following baseline BMI categories: <30, ≥30 to <35, and ≥ 35 kg/m 2  .
RESULTS


In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies. No statistically significant treatment-by-BMI category interactions were found for reductions in HbA1c.
CONCLUSION


This post hoc analysis of eight AWARD studies indicates that baseline BMI does not affect the relative treatment efficacy of dulaglutide as measured by HbA1c change from baseline in any study. Dulaglutide is an effective treatment option for adult patients with type 2 diabetes regardless of their baseline BMI category.",2019,"In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies.","['Changes from baseline in HbA1c data from patients treated with 1.5 mg or 0.75\u2009mg', 'adult patients with type 2 diabetes regardless of their baseline BMI category', 'dulaglutide-treated patients, a post hoc analysis was conducted on HbA1c and baseline BMI data from eight AWARD studies, with a total of 5770 patients', 'patients with type 2 diabetes regardless of body mass index']","['Dulaglutide', 'dulaglutide, active comparator or placebo']",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],5770.0,0.132958,"In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies.","[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Gentilella', 'Affiliation': 'Eli Lilly Italia S.p.A., Sesto Fiorentino, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Surgical Science, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vazquez', 'Affiliation': 'Hospital Marqués de Valdecilla, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Sapin', 'Affiliation': 'Lilly France, Neuilly-sur-Seine, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Reed', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Romera', 'Affiliation': 'Lilly S.A., Alcobendas, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Endocrinology & Diabetes, University Campus Bio-Medico, Rome, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13853']
1931,31451419,"Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study.","BACKGROUND


Use of single-bed rooms for control of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae is under debate; the added value when applying contact precautions has not been shown. We aimed to assess whether an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae.
METHODS


We did a cluster-randomised, crossover, non-inferiority study on medical and surgical wards of 16 Dutch hospitals. During two consecutive study periods, either contact precautions in a single-bed room or contact precautions in a multiple-bed room were applied as the preferred isolation strategy for patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients). Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram. Hospitals were randomly assigned in a 1:1 ratio by computer to one of two sequences of isolation strategies, stratified by university or non-university hospital. Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients. The primary outcome was transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBL-producing Enterobacteriaceae isolate that was clonally related to the index patient's isolate in at least one wardmate. The primary analysis was done in the per-protocol population, which included patients who were adherent to the assigned room type. A 10% non-inferiority margin for the risk difference was used to assess non-inferiority. This study is registered with Nederlands Trialregister, NTR2799.
FINDINGS


16 hospitals were randomised, eight to each sequence of isolation strategies. All hospitals randomised to the sequence single-bed room then multiple-bed room and five of eight hospitals randomised to the sequence multiple-bed room then single-bed room completed both study periods and were analysed. From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12 875 wardmates were assessed for eligibility. Of those, 693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population. Transmission of ESBL-producing Enterobacteriaceae to at least one wardmate was identified for 11 (4%) of 275 index patients during the single-bed room strategy period and for 14 (7%) of 188 index patients during the multiple-bed room strategy period (crude risk difference 3·4%, 90% CI -0·3 to 7·1).
INTERPRETATION


For patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample, an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae. Non-inferiority of the multiple-bed room strategy might change the current single-bed room preference for isolation of patients with ESBL-producing Enterobacteriaceae and, thus, broaden infection-control options for ESBL-producing Enterobacteriaceae in daily clinical practice.
FUNDING


Netherlands Organisation for Health Research and Development.",2019,"Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients.","['patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients', '693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population', '16 hospitals', 'medical and surgical wards of 16 Dutch hospitals', 'patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals', 'Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram', 'From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12\u2008875 wardmates were assessed for eligibility']",[],"['transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBL-producing Enterobacteriaceae isolate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1720786', 'cui_str': 'Antibiogram'}, {'cui': 'C4517897', 'cui_str': '875'}]",[],"[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}]",693.0,0.091772,"Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients.","[{'ForeName': 'Marjolein F Q', 'Initials': 'MFQ', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Department of Infection Control, Amphia Hospital, Breda, Netherlands; Amphia Academy Infectious Disease Foundation, Amphia Hospital, Breda, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands. Electronic address: marjoleinkluytmans@gmail.com.'}, {'ForeName': 'Patricia C J', 'Initials': 'PCJ', 'LastName': 'Bruijning-Verhagen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Christina M J E', 'Initials': 'CMJE', 'LastName': 'Vandenbroucke-Grauls', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Els I G B', 'Initials': 'EIGB', 'LastName': 'de Brauwer', 'Affiliation': 'Department of Medical Microbiology, Atrium Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'Anton G M', 'Initials': 'AGM', 'LastName': 'Buiting', 'Affiliation': 'Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Bram M', 'Initials': 'BM', 'LastName': 'Diederen', 'Affiliation': 'Regional Laboratory of Public Health, Haarlem, Netherlands; Microvida Laboratory for Microbiology, Bravis Hospital, Roosendaal, Netherlands.'}, {'ForeName': 'Erika P M', 'Initials': 'EPM', 'LastName': 'van Elzakker', 'Affiliation': 'Department of Microbiology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Alex W', 'Initials': 'AW', 'LastName': 'Friedrich', 'Affiliation': 'Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Hopman', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Nashwan', 'Initials': 'N', 'LastName': 'Al Naiemi', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Ziekenhuisgroep Twente, Almelo/Hengelo, Netherlands.'}, {'ForeName': 'John W A', 'Initials': 'JWA', 'LastName': 'Rossen', 'Affiliation': 'Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Gijs J H M', 'Initials': 'GJHM', 'LastName': 'Ruijs', 'Affiliation': 'Laboratory for Microbiology and Infectious Diseases, Isala Clinics, Zwolle, Netherlands.'}, {'ForeName': 'Paul H M', 'Initials': 'PHM', 'LastName': 'Savelkoul', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Medical Microbiology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Verhulst', 'Affiliation': 'Microvida Laboratory for Microbiology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Voss', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Medical Microbiology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Jan A J W', 'Initials': 'JAJW', 'LastName': 'Kluytmans', 'Affiliation': 'Department of Infection Control, Amphia Hospital, Breda, Netherlands; Microvida Laboratory for Microbiology, Amphia Hospital, Breda, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30262-2']
1932,31450969,A randomized trial of telemedicine for migraine management.,"OBJECTIVE


To determine whether synchronous video-based telemedicine visits with specialists are feasible and to evaluate clinical effectiveness, patient perceptions, and other benefits of telemedicine visits for follow-up migraine care in a tertiary headache center.
DESIGN


A one-year, randomized clinical trial.
RESULTS


Fifty patients were screened and 45 entered the study (43 women, two men). Out of 96 scheduled visits, 89 were successfully conducted using telemedicine. Eighteen patients (out of 22) in the telemedicine cohort and 12 patients (out of 23) in the in-office cohort completed the study. In this small study, clinical outcomes, namely improvement in MIDAS, number of headache days, and average severity at 12 months for participants in the telemedicine group, were not different from those in the in-office group. Convenience was rated higher and visit times were shorter in the telemedicine group.
CONCLUSIONS


In this cohort of patients with severe migraine-related disability, telemedicine was a feasible mode of treatment and an effective alternative to in-office visits for follow-up migraine care. Physician productivity could be higher with telemedicine, and patients may get better access because of its convenience.
TRIAL REGISTRATION


This study is listed on ClinicalTrials.gov (NCT01706003).",2019,"Convenience was rated higher and visit times were shorter in the telemedicine group.
","['Fifty patients were screened and 45 entered the study (43 women, two men', 'Eighteen patients (out of 22) in the telemedicine cohort and 12 patients (out of 23) in the in-office cohort completed the study']","['synchronous video-based telemedicine visits', 'telemedicine']","['MIDAS, number of headache days, and average severity', 'Physician productivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",89.0,0.0901954,"Convenience was rated higher and visit times were shorter in the telemedicine group.
","[{'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Balaraman', 'Initials': 'B', 'LastName': 'Rajan', 'Affiliation': 'College of Business and Economics, California State University East Bay, Hayward, CA, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Seidmann', 'Affiliation': 'Simon Business School, University of Rochester, Rochester, NY, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419868250']
1933,31451902,Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).,"AIM


Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles.
PATIENTS AND METHODS


73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT). In dependence of defect location, patients were divided into two groups [patella defects (n = 45) and femoral condyle defects (n = 28)]. Clinical outcome was evaluated by the means of the KOOS score at baseline and 6 weeks, 3, 6, 12, 18, 24, 36, 48 and 60 months following ACI.
RESULTS


""Responder rate"" at 60 months (improvement from baseline of > 7 points in the KOOS score) in patients with patella defects was 86.2%. All scores showed a significant improvement from baseline. While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6 (SD 14.0) was observed in patella defects (p = 0.2483).
CONCLUSION


ACI seems an appropriate surgical treatment for cartilage defects of the patella leading to a high success rate. In this study, the clinical outcome in patients with patellar defects was even better than the already excellent results in patients with defects of the femoral condyle even though the study included relatively large defect sizes for both groups (mean defect size 6.0 ± 1.7 and 5.4 ± 1.6 for femur and patella, respectively).",2020,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","['patients with patellar defects', '73 patients with a follow-up of 5\xa0years']","['autologous chondrocyte implantation (ACI', 'ACI']","['KOOS score', 'overall KOOS score', 'patella defects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",73.0,0.129378,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Germany and OCM Clinic, OCM | Orthopädische Chirurgie München, Steinerstrass 6, 83069, Munich, Germany. phniemeyer@gmail.com.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Laute', 'Affiliation': 'Joint and Spine Centre, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zinser', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Vinzenz-Hospital, Dinslaken, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becher', 'Affiliation': 'Department of Orthopedic Surgery, Medical University Annastift Hanover, Hanover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diehl', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Orthopedic Center Munich East, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kolombe', 'Affiliation': 'Traumatology and Reconstructive Surgery, DRK Hospital Luckenwalde, Luckenwalde, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Fay', 'Affiliation': 'Department of Traumatology and Arthroscopic Surgery, Lubinus Clinicum Kiel, Kiel, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Siebold', 'Affiliation': 'Center for Hip, Knee and Foot Surgery, ATOS Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fickert', 'Affiliation': 'Sporthopaedicum Straubing, Straubing, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03264-x']
1934,31356921,Oral Janus kinase/SYK inhibition (ASN002) suppresses inflammation and improves epidermal barrier markers in patients with atopic dermatitis.,"BACKGROUND


Moderate-to-severe atopic dermatitis (AD) has been associated with significant disease burden and systemic abnormalities and often requires systemic treatments. Currently, safe and effective oral systemic treatments for moderate-to-severe AD are not yet available. ASN002 is an oral inhibitor of the Janus kinase/spleen tyrosine kinase signaling pathways, targeting several cytokine axes (T H 2/T H 22/T H 17/T H 1) and epidermal differentiation.
OBJECTIVE


We sought to evaluate the effect of ASN002 on the cellular and molecular biomarker profile of patients with moderate-to-severe AD and to correlate changes in biomarkers to improvements in clinical severity measures and pruritus.
METHODS


Thirty-six patients with moderate-to-severe AD were randomized to groups with dose escalation of ASN002 (20, 40, and 80 mg) and a placebo group. Skin biopsy specimens were performed at baseline, day 15, and day 29. Gene expression studies were conducted by using microarray and quantitative RT-PCR, and cellular infiltrates and protein expression were studied by using immunohistochemistry.
RESULTS


ASN002 reversed the lesional skin transcriptome toward a nonlesional phenotype. It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures (filaggrin [FLG] and CLDN23). Significant improvements in AD gene signatures were observed predominantly in the 40- and 80-mg groups. Smaller and largely nonsignificant molecular changes were seen in the 20-mg and placebo groups.
CONCLUSION


The Janus kinase/spleen tyrosine kinase inhibitor ASN002 significantly suppressed key AD inflammatory pathways, corresponding to clinical response. ASN002 might be an effective novel therapeutic agent for moderate-to-severe AD.",2019,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","['Thirty-six patients with moderate-to-severe AD', 'patients with moderate-to-severe AD', 'patients with atopic dermatitis']","['Oral Janus kinase/SYK inhibition (ASN002', 'ASN002', 'placebo']","['IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures', 'AD gene signatures', 'T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G', 'lesional skin transcriptome', 'epidermal barrier markers']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0123771', 'cui_str': 'Receptors, IL-4'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C1959608', 'cui_str': 'TARC Chemokine'}, {'cui': 'C4319742', 'cui_str': 'Macrophage Inflammatory Protein 4'}, {'cui': 'C1098076', 'cui_str': 'Macrophage-Derived Chemokine'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C1579194', 'cui_str': 'Protease Inhibitor WAP3'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}]",36.0,0.0336823,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","[{'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hyun-Je', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Del Duca', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Denis', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Zammit', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.013']
1935,31453933,Dietary Intake and Energy Expenditure During Two Different Phases of Athletic Training in Female Collegiate Lacrosse Players.,"Kumahara, H, Ohta, C, Nabeshima, E, Nakayama, A, Mine, S, and Yamato, T. Dietary intake and energy expenditure during two different phases of athletic training in female collegiate lacrosse players. J Strength Cond Res 34(6): 1547-1554, 2020-This study aims to investigate the state of nutrient intake and energy expenditure (EE) among various phases of periodization in female collegiate lacrosse players. A total of 17 Japanese female collegiate lacrosse players (age: 20.0 ± 0.9 years) were enrolled in this study. Physical activity (PA) and dietary intake were assessed over each 1-week period during the training preparatory phase (P-phase) and transition phase (T-phase). The exercise training-related EE (EEE) and EE associated with other daily living activities (i.e., nonexercise activity thermogenesis [NEAT]), were measured using accelerometers and heart rate (HR) monitoring using the flex-HR method. The total daily EE during the P-phase was significantly higher than that of the T-phase (2,168 ± 248 vs. 1744 ± 138 kcal·d; p < 0.01); however, no significant differences were observed in the total energy intake. Moreover, EEE during the P-phase was significantly higher than that of the T-phase, whereas no significant difference was found in NEAT. Furthermore, no significant differences were noted in any macronutrient intake variable observed between the 2 phases (protein:fat:carbohydrate ratio: 12.6 ± 1.5:32.9 ± 3.9:54.1 ± 5.1% in the P-phase vs. 12.1 ± 1.7:30.7 ± 3.9:55.7 ± 5.2% in the T-phase). The carbohydrate and protein intake were below recommended levels during the P-phase. Conversely, the saturated fatty acid ratio was higher than the dietary goals for disease prevention. Based on the changes in the PA volume observed during different training phases, female collegiate lacrosse players did not attain optimal nutrient intake required for optimal athletic performance and health.",2020,"Furthermore, no significant differences were noted in any macronutrient intake variable observed between the 2 phases (protein:fat:carbohydrate ratio: 12.6 ± 1.5:32.9 ± 3.9:54.1 ± 5.1% in the P-phase vs. 12.1 ± 1.7:30.7 ± 3.9:55.7 ± 5.2% in the T-phase).","['Female Collegiate Lacrosse Players', 'female collegiate lacrosse players', '17 Japanese female collegiate lacrosse players (age: 20.0 ± 0.9 years']","['Athletic Training', 'athletic training', 'nutrient intake and energy expenditure (EE', 'J Strength Cond Res XX(X', 'exercise training-related EE (EEE) and EE associated with other daily living activities (i.e., nonexercise activity thermogenesis [NEAT']","['carbohydrate and protein intake', 'accelerometers and heart rate (HR) monitoring', 'saturated fatty acid ratio', 'Physical activity (PA) and dietary intake', 'macronutrient intake', 'total energy intake', 'total daily EE', 'Dietary Intake and Energy Expenditure', 'Kumahara, H, Ohta, C, Nabeshima, E, Nakayama, A, Mine, S, and Yamato, T. Dietary intake and energy expenditure']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",17.0,0.0116072,"Furthermore, no significant differences were noted in any macronutrient intake variable observed between the 2 phases (protein:fat:carbohydrate ratio: 12.6 ± 1.5:32.9 ± 3.9:54.1 ± 5.1% in the P-phase vs. 12.1 ± 1.7:30.7 ± 3.9:55.7 ± 5.2% in the T-phase).","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kumahara', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Nutritional Sciences, Nakamura Gakuen University, Fukuoka, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Ohta', 'Affiliation': ''}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Nabeshima', 'Affiliation': ''}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Nakayama', 'Affiliation': ''}, {'ForeName': 'Sayoko', 'Initials': 'S', 'LastName': 'Mine', 'Affiliation': ''}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Yamato', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003335']
1936,32441643,Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice.,"OBJECTIVES


A potential point of concern among clinicians is whether results derived from the clinical trials can be reasonably applied or generalised to a definable group of patients seen in real world. It can be the case of the GiACTA study that is a phase III randomised controlled trial of tocilizumab (TCZ) in giant cell arteritis (GCA). To address this question, we compared the clinical features and the responses to TCZ from the GiACTA trial patients with those from a series of GCA seen in the daily clinical practice.
METHODS


Comparative study of clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134). The diagnosis of GCA in the GiACTA trial was established by the ACR modified criteria whereas in the series of real-world patients it was made by using the ACR criteria, a positive biopsy of temporal artery or the presence of imaging techniques consistent with large-vessel vasculitis in individuals who presented cranial symptoms of GCA. GiACTA trial patients received subcutaneous TCZ (162 mg every 1 or 2 weeks) whereas those from the clinical practice series were treated using standard IV dose (8 mg/kg/month) or subcutaneous (162 mg/week).
RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial. Despite clinical differences, TCZ was equally effective in both GiACTA trial and clinical practice patients. However, serious infections were more commonly observed in GCA patients recruited from the clinical practice.
CONCLUSIONS


Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ in GCA.",2020,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","['giant cell arteritis', 'clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134', 'GiACTA trial patients with those from a series of GCA seen in the daily clinical practice']","['subcutaneous TCZ', 'TCZ', 'conventional immunosuppressive therapy (mainly methotrexate', 'Tocilizumab', 'tocilizumab (TCZ']",['serious infections'],"[{'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C4510396', 'cui_str': 'Tocilizumab therapy'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0362626,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Calderón-Goercke', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Castañeda', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Aldasoro', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario de Navarra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Villa', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Prieto-Peña', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Atienza-Mateo', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Patiño', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Moriano', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de León, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Romero-Yuste', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Narváez', 'Affiliation': 'Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Gómez-Arango', 'Affiliation': 'Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pérez-Pampín', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Melero', 'Affiliation': 'Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Becerra-Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Marcelino', 'Initials': 'M', 'LastName': 'Revenga', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Álvarez-Rivas', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Galisteo', 'Affiliation': 'Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Sivera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Olivé-Marqués', 'Affiliation': 'Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez Del Buergo', 'Affiliation': 'Department of Rheumatology, Hospital Río Carrión, Palencia, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Marena-Rojas', 'Affiliation': 'Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-López', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Navarro', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Raya', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Galindez-Agirregoikoa', 'Affiliation': 'Department of Rheumatology, Hospital de Basurto, Bilbao, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arca', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Solans-Laqué', 'Affiliation': 'Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Conesa', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hidalgo', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'José Andrés', 'Initials': 'JA', 'LastName': 'Román-Ivorra', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Loricera', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Lluch', 'Affiliation': 'Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Manrique-Arija', 'Affiliation': 'Department of Rheumatology, Hospital Regional de Málaga, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Vela', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Alicante, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'De Miguel', 'Affiliation': 'Department of Rheumatology, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Torres-Martín', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Nieto', 'Affiliation': 'Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ordas-Calvo', 'Affiliation': 'Department of Rheumatology, Hospital Cabueñes, Gijón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Salgado-Pérez', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Luna-Gomez', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Toyos-Sáenz de Miera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Nagore', 'Initials': 'N', 'LastName': 'Fernández-Llanio', 'Affiliation': 'Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Larena', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'González-Vela', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Corrales', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Varela-García', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Aurrecoechea', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Manzanares', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Ortego', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortiz-Sanjuán', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Corteguera', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Hernández', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'González-Gay', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. miguelaggay@hotmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. rblanco@humv.es.'}]",Clinical and experimental rheumatology,[]
1937,31311761,"Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in MRI-Defined Locally Advanced T3 Resectable Rectal Cancer: Final Results of a Randomized, Noncomparative Phase 2 INOVA Study.","BACKGROUND


Recurrence and distant metastases remain a significant issue in locally advanced rectal cancer (LARC). Several multimodal strategies are assessed in clinical trials.
PATIENTS AND METHODS


Patients with mid/low magnetic resonance imaging-defined high-risk LARC were randomized to arm A (12-week bevacizumab + FOLFOX-4 then bevacizumab-5-fluorouracil [5-FU]-radiotherapy [RT] before total mesorectal excision [TME]) or arm B (bevacizumab-5-FU-RT then TME). Long-term efficacy and safety up to 5 years' follow-up are reported. No comparison between arms was planned.
RESULTS


Overall, 91 patients (46 in arm A and 45 in arm B) were included. Main results have been presented previously. During the late follow-up period (> 4 weeks after surgery), 4 patients (8.7%) in arm A and 4 (8.9%) in arm B experienced grade 3/4 adverse events related to bevacizumab; the most frequent were 2 anastomotic fistulas (both in arm A) and abscesses (1 in arm A and 2 in arm B). At 5 years' follow-up, 9 (19.6%) and 11 (24.4%) patients in arms A and B developed a fistula in the year after surgery, and 2 (4.3%) in arm A at > 1 year after surgery. Most resolved before study end. Five-year disease-free survival was 70% and 64.3% in arms A and B, respectively. Five-year overall survival was 90.5% (95% confidence interval, 76.7, 96.3) in arm A and 72.7% (95% confidence interval, 56.0, 83.9) in arm B.
CONCLUSION


Neoadjuvant bevacizumab + FOLFOX-4 may have the potential to increase survival outcomes when followed by bevacizumab-5-FU-RT and TME in LARC. Bevacizumab-5-FU-RT then TME was associated with a higher-than-projected rate of anastomotic fistulas. Further research of neoadjuvant strategies in LARC is encouraged.",2019,"Five-year overall survival was 90.5% (95% confidence interval, 76.7, 96.3) in arm A and 72.7% (95% confidence interval, 56.0, 83.9) in arm B.
CONCLUSION


","['Patients with mid/low magnetic resonance imaging-defined high-risk LARC', 'MRI-Defined Locally Advanced T3 Resectable Rectal Cancer', '91 patients (46 in arm A and 45 in arm B) were included', 'locally advanced rectal cancer (LARC']","['Two Neoadjuvant Strategies', 'bevacizumab', 'bevacizumab\xa0+ FOLFOX-4 then bevacizumab-5-fluorouracil', 'Bevacizumab', 'total mesorectal excision [TME]) or arm B (bevacizumab-5-FU-RT then TME', 'Neoadjuvant bevacizumab', 'Bevacizumab-5-FU-RT', '5-FU]-radiotherapy [RT']","['overall survival', 'survival outcomes', 'Efficacy and Safety', 'Five-year disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",91.0,0.132893,"Five-year overall survival was 90.5% (95% confidence interval, 76.7, 96.3) in arm A and 72.7% (95% confidence interval, 56.0, 83.9) in arm B.
CONCLUSION


","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon and CIC-BT506, Besançon, France. Electronic address: christophe.borg@efs.sante.fr.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Mantion', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon and CIC-BT506, Besançon, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Boudghène', 'Affiliation': 'Department of Radiology, Tenon Hospital, Paris, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Mornex', 'Affiliation': 'Department of Radiotherapy, Lyon-Sud Hospital Center, Lyon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Department of Medicine, Georges-François-Leclerc Center, Dijon, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'Department of Medical Oncology, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': 'ICM Cancer Institute of Montpellier, Montpellier, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balosso', 'Affiliation': 'ICM Cancer Institute of Montpellier, Montpellier, France.'}, {'ForeName': 'Meher', 'Initials': 'M', 'LastName': 'Ben Abdelghani', 'Affiliation': 'Gastroenterologist, Paul Strauss Center, Strasbourg, France.'}, {'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Gastroenterologist, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'François', 'Affiliation': 'Department of Surgery, CHU Lyon Sud, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Conroy', 'Affiliation': 'Department of Medical Oncology, Lorraine Cancer Institute, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Rio', 'Affiliation': ""Department of Radiotherapy Oncology, Institut de Cancérologie de l'Ouest (ICO), Saint-Herblain, France.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Roullet', 'Affiliation': 'Department of Radiotherapy Oncology, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Spaëth', 'Affiliation': 'Department of Medical Oncology, Gentilly Oncology Center, Nancy, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Quero', 'Affiliation': 'Department of Radiotherapy Oncology, CHU Saint Louis, Paris, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon and CIC-BT506, Besançon, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Coudert', 'Affiliation': 'Roche Laboratories, Boulogne-Billancourt, France.'}, {'ForeName': 'Miruna', 'Initials': 'M', 'LastName': 'Ionescu-Goga', 'Affiliation': 'Roche Laboratories, Boulogne-Billancourt, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Tanang', 'Affiliation': 'Roche Laboratories, Boulogne-Billancourt, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Saint Antoine Hospital and Pierre et Marie Curie University, UMPC Paris, Paris, France.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2019.04.006']
1938,30728488,Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab.,"BACKGROUND


Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections.
METHOD


Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year.
RESULTS


There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33).
CONCLUSION


The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.",2019,"For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33).
","['Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia', 'diabetic macular oedema treated with', 'Diabetic macular oedema (DMO', '49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab\u2009+\u2009PRP group recruited at seven UK sites']","['PRP plus ranibizumab or ranibizumab monotherapy', 'panretinal photocoagulation (PRP', 'wide-field guided PRP', 'ranibizumab']","['average number of injections', 'number of 6- to 12-month injections', 'number of repeat injections required after the first 6 months up until 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0162291', 'cui_str': 'Retinal ischemia (disorder)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",49.0,0.144899,"For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33).
","[{'ForeName': 'S James', 'Initials': 'SJ', 'LastName': 'Talks', 'Affiliation': 'Newcastle Eye Centre, Newcastle Upon Tyne NHS Hospitals Foundation Trust, Tyne and Wear, UK. James.talks@nuth.nhs.uk.'}, {'ForeName': 'Devangna', 'Initials': 'D', 'LastName': 'Bhatia', 'Affiliation': 'Newcastle Eye Centre, Newcastle Upon Tyne NHS Hospitals Foundation Trust, Tyne and Wear, UK.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Menon', 'Affiliation': 'Frimley Park Hospitals NHS Foundation Trust, Camberley, GU16 7UJ, UK.'}, {'ForeName': 'Abosede', 'Initials': 'A', 'LastName': 'Cole', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8AE, UK.'}, {'ForeName': 'Haralabos', 'Initials': 'H', 'LastName': 'Eleftheriadis', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Downey', 'Affiliation': 'Hull Royal Infirmary, Hull and East Yorkshire Hospitals NHS Trust, Hull, HU3 2JZ, UK.'}, {'ForeName': 'Ngai Victor', 'Initials': 'NV', 'LastName': 'Chong', 'Affiliation': 'Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, EC1, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Eye (London, England)",['10.1038/s41433-019-0342-1']
1939,32441467,"Moist exposed burn therapy in recovery of patients with immature, red hypertrophic scars successfully treated with a pulsed dye laser in combination with a fractional CO 2  laser.","BACKGROUND


The efficacy of pulsed dye laser combined (PDL) and UltraPulse fractional CO 2  in treatment of hypertrophic scars is well documented. The present study investigates the efficacy of moist exposed burn ointment (MEBO)/moist exposed burn therapy (MEBT) in postlaser wound management.
METHODS


Sixty-one patients with immature, red hypertrophic scars were enrolled in this clinical trial. Patients were randomly divided into two groups: (a) the MEBO treatment group (n = 30) and (b) the control group (n = 31) treated with chlortetracycline hydrochloride ointment. Demographic data such as age, gender, and cause of scars were recorded. A visual analogue score (VAS) was collected to measure pain at 1, 6, 24, 72 hours, and 7 days post-treatment. The Vancouver Scar Scale (VSS) was used to determine the response of the scars before and 3 months after the treatment. The wound healing time and pigmentation scores were also recorded.
RESULTS


No significant differences were found in age, gender, and etiology of the scars in the two groups. The VAS scores in MEBO group were significantly lower than the control group within the first 3 days after treatment. The wound healing time of the MEBO group was significantly shorter than the control group. For both groups, VSS scores were significantly decreased and the scar markedly improved. However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
CONCLUSION


MEBT/MEBO treatment reduced the post-treatment pain, shortened the wound healing duration, promoted the overall scar condition, and reduced the incidence of pigmentation.",2020,"However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
","['patients with immature, red hypertrophic scars', 'Sixty-one patients with immature, red hypertrophic scars']","['pulsed dye laser in combination with a fractional CO 2  laser', 'moist exposed burn ointment (MEBO)/moist exposed burn therapy (MEBT', 'MEBO treatment', 'MEBO', 'Moist exposed burn therapy', 'pulsed dye laser combined (PDL', 'chlortetracycline hydrochloride ointment', 'MEBT/MEBO']","['A visual analogue score (VAS', 'wound healing duration', 'overall scar condition', 'wound healing time', 'pigmentation formation', 'Vancouver Scar Scale (VSS', 'incidence of pigmentation', 'wound healing time and pigmentation scores', 'VSS scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C1174850', 'cui_str': 'moist exposed burn ointment'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085855', 'cui_str': 'Chlortetracycline hydrochloride'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",61.0,0.0151803,"However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
","[{'ForeName': 'Xiao-Jia', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Hua-Wei', 'Initials': 'HW', 'LastName': 'Ouyang', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Ying-', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Yu', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': 'Gold Skin Care Center, Nashville, TN, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}]",Journal of cosmetic dermatology,['10.1111/jocd.13426']
1940,32441571,Effects of inverse ratio ventilation combined with lung protective ventilation on pulmonary function in patients with severe burns for surgery.,"OBJECTIVE


To investigate the effects of inverse ratio ventilation combined with lung-protective ventilation on pulmonary function and inflammatory factors in severe burn patients undergoing surgery.  Populations and Methods : Eighty patients with severe burns undergoing elective surgery were divided randomly into two groups: control (CG,  n  = 40) and experiment (EG,  n  = 40). The CG had conventional ventilation, whereas the EG were ventilated with tidal volume (TV) of 6-8 ml/kg, I (inspiration): E (expiration) of 2:1, and positive end-expiratory pressure (PEEP) 5 cm H2O. The following variables were evaluated before (T0), 1 h after start of surgery (T1) and after surgery (T2): oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications.  Results : At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG. At the end of the surgery, the Lac was significantly smaller in the EG than in the CG (1.28 ± 0.19 vs. 1.40 ± 0.23 mmol/L). Twenty-four hours after the surgery, significantly more patients had hypoxemia (27.5 vs. 10.0%), increased expectoration (45.0 vs. 22.5%), increased lung texture or exudation (37.5 vs. 17.5%) in the CG than in the EG.  Conclusions : Inverse ratio ventilation combined with lung-protective ventilation can reduce Ppeak, increase Pmean and Cdyn, improve the pulmonary oxygenation function, and decrease ILs in severe burn surgery patients.",2020,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","['severe burn patients undergoing surgery', 'Populations and Methods ', 'severe burn surgery patients', 'Eighty patients with severe burns undergoing elective surgery', 'patients with severe burns for surgery']","['inverse ratio ventilation combined with lung-protective ventilation', 'inverse ratio ventilation combined with lung protective ventilation', 'Inverse ratio ventilation combined with lung-protective ventilation']","['pulmonary function and inflammatory factors', 'increased lung texture or exudation ', 'OI, Pmean and Cdyn', 'oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications', 'pulmonary oxygenation function', 'increased expectoration', 'pulmonary function', 'Lac', 'TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10', 'hypoxemia ']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",80.0,0.0594429,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","[{'ForeName': 'Yan-Chao', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Huai', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Shu-Zhen', 'Initials': 'SZ', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Cao', 'Affiliation': 'Respiratory Department, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}]",The Libyan journal of medicine,['10.1080/19932820.2020.1767276']
1941,31447409,"Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.","BACKGROUND


In the Denosumab and Teriparatide Administration (DATA) study, we showed that denosumab fully inhibits teriparatide-induced bone resorption while allowing for continued teriparatide-induced bone formation, resulting in larger increases in hip and spine bone mineral density (BMD) than with either drug alone. We aimed to assess whether administration of denosumab with high dose teriparatide would stimulate larger increases in bone mass than those observed in the DATA study.
METHODS


DATA-HD was an open-label, randomised, controlled phase 4 trial done at Massachusetts General Hospital. Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis. Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months. At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months. Areal BMD (aBMD) was measured at 0, 3, 9, and 15 months. Treatment was given open label, but outcome assessors were masked. The primary endpoint was percentage change from baseline in spine areal BMD (aBMD) at 15 months. Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis. Safety was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02176382.
FINDINGS


Between Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility. 76 participants were randomly assigned to 20 μg teriparatide (n=39) or 40 μg teriparatide (n=37), of whom 69 completed at least one post-baseline visit. At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001). Mean femoral neck aBMD had also increased to a greater extent in the 40 μg group (6·8% [SD 4·1] increase) than the 20 μg group (4·3% [3·7]; difference 2·5%, 0·5 to 4·5, p=0·04), as did mean total hip aBMD (40 μg group, 6·1% [3·4] increase; 20 μg group, 3·9% [2·9] increase; difference 2·2%, 0·6 to 3·8, p<0·0001). 30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events. The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group. No deaths were reported.
INTERPRETATION


Combined treatment with teriparatide 40 μg and denosumab increases spine and hip BMD more than standard combination therapy. This large and rapid increase in bone mass suggest that this high dose regimen might provide a method of restoring skeletal integrity in patients with osteoporosis.
FUNDING


National Institutes of Health and the Dart Foundation.",2019,"At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001).","['76 participants', 'Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis', 'postmenopausal osteoporosis (DATA-HD', 'Between Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility', 'Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis', 'patients with osteoporosis']","['denosumab', '40 μg teriparatide', 'teriparatide', 'teriparatide 40 μg and denosumab', 'Combination denosumab and high dose teriparatide', 'teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection', 'Denosumab and Teriparatide']","['fatigue', 'serious adverse events', 'hip and spine bone mineral density (BMD', 'Areal BMD (aBMD', 'joint pain', 'percentage change from baseline in spine areal BMD (aBMD', 'spine and hip BMD', 'adverse event', 'muscle cramp', 'Mean femoral neck aBMD', 'mean total hip aBMD', 'mean spine aBMD', 'nausea', 'Safety', 'bone mass']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",76.0,0.416508,"At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001).","[{'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA. Electronic address: jntsai@mgh.harvard.edu.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30255-4']
1942,30768394,A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual.,"OBJECTIVE


This single-blind, randomized, multisite, intent-to-treat study was designed to replicate and extend Dawson et al.'s (Pediatrics. 2010;125: e17-e23) randomized controlled trial testing the effects of the Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings.
METHOD


A randomized controlled trial was conducted at 3 universities. One hundred eighteen children 14 to 24 months old with autism spectrum disorder were enrolled and randomly assigned to ESDM or community interventions for 27 months. Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses. Children assigned to the ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist.
RESULTS


For the primary analyses, there were time-by-group and time-by-group-by-site interactions for language outcome. In the significant 3-way interaction involving site, 2 sites showed a significant ESDM advantage and the third site showed no significant group differences. In the planned 2-way analysis that pooled data across all 3 sites, there was a significant advantage found for the ESDM group. For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior. The treatment effect of group on language outcomes was not moderated by baseline developmental quotient, autism severity, or language.
CONCLUSION


Results of the primary analysis provide a partial replication of Dawson et al.'s 2010 language findings.
CLINICAL TRIAL REGISTRATION INFORMATION


Intensive Intervention for Toddlers with Autism; https://clinicaltrials.gov/; NCT00698997.",2019,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","['Toddlers with Autism', 'One hundred eighteen children 14 to 24 months old with autism spectrum disorder', 'Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses']","['ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist', 'Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings', 'ESDM or community interventions']","['baseline developmental quotient, autism severity, or language', 'partial replication of Dawson et', 'developmental quotient, autism severity, or adaptive behavior']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}]",118.0,0.195291,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","[{'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento. Electronic address: sjrogers@ucdavis.edu.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lord', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greenson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Colombi', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Whelan', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.004']
1943,32441691,Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.,"BACKGROUND


Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations.
OBJECTIVES


This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL.
METHODS


20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations.
FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.",2020,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","['Breast Cancer Survivors', 'breast cancer survivors', '20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment']","['WCIs', 'Wellness coaching interventions (WCIs', 'person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations', 'Wellness Coaching']","['dietary habits, weight, and QOL', 'physical activity level, dietary habits', 'survival rates and quality of life (QOL']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0242179,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","[{'ForeName': 'Daniela L', 'Initials': 'DL', 'LastName': 'Stan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Cutshall', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Tammy F', 'Initials': 'TF', 'LastName': 'Adams', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kaisa C', 'Initials': 'KC', 'LastName': 'Wieneke', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Esayas B', 'Initials': 'EB', 'LastName': 'Kebede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Donelan Dunlap', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Hazelton', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Alissa M', 'Initials': 'AM', 'LastName': 'Butts', 'Affiliation': 'Medical College of Wisconsin.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Mayo Clinic.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.305-315']
1944,32441659,"Investigating the Efficacy and Cost-Effectiveness of Technology-Delivered Personalized Feedback on Dietary Patterns in Young Australian Adults in the Advice, Ideas, and Motivation for My Eating (Aim4Me) Study: Protocol for a Randomized Controlled Trial.","BACKGROUND


Web-based health interventions may be easier to access and time efficient relative to face-to-face interventions and therefore may be the most appropriate mode to engage young adults.
OBJECTIVE


This study aims to investigate the impact of 3 different levels of personalized web-based dietary feedback and support on changes in diet quality.
METHODS


The Advice, Ideas, and Motivation for My Eating (Aim4Me) study is a 12-month assessor-blinded, parallel-group randomized controlled trial evaluating the impact of 3 levels of web-based feedback on diet quality, measured using the Australian Recommended Food Score (ARFS). Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups. Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality. Individuals randomized to this group can use the brief feedback report to make positive dietary changes. Group 2 will receive the Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake. Group 2 will use the comprehensive feedback report to assist in making positive dietary changes. They will also have access to the Aim4Me website with resources on healthy eating and tools to set goals and self-monitor progress. Group 3 will receive the same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes. The self-determination theory was used as the framework for selecting appropriate website features, including goal setting and self-monitoring. The primary outcome measure is change in diet quality. The completion of questionnaires at baseline and 3, 6, and 12 months will be incentivized with a monetary prize draw.
RESULTS


As of December 2019, 1277 participants have been randomized.
CONCLUSIONS


The web-based delivery of nutrition interventions has the potential to improve dietary intake of young adults. However, the level of support required to improve intake is unknown.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618000325202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374420.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15999.",2020,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","['Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups', 'Young Australian Adults', '1277 participants have been randomized', 'young adults']","['Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake', 'personalized web-based dietary feedback', 'Technology-Delivered Personalized Feedback', 'Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality', 'same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes']",['change in diet quality'],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",2570.0,0.0978523,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Pezdirc', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, North Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Truby', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hutchesson', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, Curtin Institute of Technology, Perth, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kirkpatrick', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McCaffrey', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}]",JMIR research protocols,['10.2196/15999']
1945,32441675,Taste Disorders: Effect of Education in Patients With Breast Cancer Receiving Chemotherapy.,"BACKGROUND


For patients with breast cancer treated with certain chemotherapy regimens, taste disorders associated with those regimens can negatively affect quality of life.
OBJECTIVES


This study evaluated the effects of taste disorder-related education on meal satisfaction and sense of taste in Japanese women with breast cancer undergoing chemotherapy.
METHODS


A sample of 53 newly diagnosed women with breast cancer scheduled for chemotherapy treatment were randomly assigned to the control or intervention (nurse-provided education about chemotherapy-associated taste disorders) group. Meal satisfaction and sense of taste were assessed using a visual analog scale.
FINDINGS


The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group. Although meal dissatisfaction and impaired sense of taste recovered in the intervention group two months after protocol completion, they did not recover in the control group. Providing education to women with breast cancer scheduled for chemotherapy treatment can affect patients' experience of treatment-associated taste disorders.
",2020,The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group.,"['Japanese women with breast cancer undergoing chemotherapy', '53 newly diagnosed women with breast cancer scheduled for chemotherapy treatment', 'women with breast cancer scheduled for', 'patients with breast cancer treated with', 'Patients With Breast Cancer Receiving Chemotherapy']","['certain chemotherapy', 'control or intervention (nurse-provided education about chemotherapy-associated taste disorders', 'taste disorder-related education', 'chemotherapy treatment']","['meal dissatisfaction and impaired sense of taste', 'Meal satisfaction and sense of taste']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039338', 'cui_str': 'Disorder of taste'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",53.0,0.0314989,The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group.,"[{'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Asano', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sawatari', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Hideko', 'Initials': 'H', 'LastName': 'Mentani', 'Affiliation': 'Shimizugaoka Senior High School.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Higashihiroshima Medical Center.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Hakodate Gryoukaku Hospital.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Fudano', 'Affiliation': 'Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Hiroshima City Asa Citizens Hospital.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Niitani', 'Affiliation': ""Yasuda Women's University.""}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'Hiroshima Kosei Hospital.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.265-271']
1946,32441658,A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.,"BACKGROUND


Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes.
OBJECTIVE


This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated.
METHODS


Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies.
RESULTS


The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F 2,146.6 =9.99; P<.001), which was similar for CAU and the intervention group (F 1,149.9 =0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F 1,149.0 =0.48; P=.07).
CONCLUSIONS


The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.",2020,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","['Patients With Cardiovascular Disease', 'Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the']","['Personalized eHealth Intervention', 'Do CHANGE intervention or care as usual (CAU', 'behavioral program in combination with ecological momentary assessment and intervention technologies']","['increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life', 'lifestyle scores', 'behavioral flexibility', 'Quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.13002,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","[{'ForeName': 'Eva Rosalinde', 'Initials': 'ER', 'LastName': 'Broers', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Willem Johan', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Mart', 'Initials': 'M', 'LastName': 'Wetzels', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Idowu', 'Initials': 'I', 'LastName': 'Ayoola', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jimenez', 'Affiliation': 'Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibovic', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}]",Journal of medical Internet research,['10.2196/14570']
1947,32441655,"A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial.","BACKGROUND


Smartphone-based learning, or mobile learning (m-learning), has become a popular learning-and-teaching strategy in educational environments. Blended learning combines strategies such as m-learning with conventional learning to offer continuous training, anytime and anywhere, via innovative learning activities.
OBJECTIVE


The main aim of this work was to examine the short-term (ie, 2-week) effects of a blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app-on knowledge, motivation, mood state, and satisfaction among undergraduate students enrolled in a health science first-degree program.
METHODS


The study was designed as a two-armed, prospective, single-blind, randomized controlled trial. Subjects who met the inclusion criteria were randomly assigned to either the intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning). For both groups, the educational program involved 13 lessons on basic health science. The iPOT app is a hybrid, multiplatform (ie, iOS and Android) smartphone app with an interactive teacher-student interface. Outcomes were measured via multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence).
RESULTS


A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group. No difference was seen between the two groups in terms of theoretical knowledge gain (P=.92). However, the intervention group subjects returned significantly higher scores than the control group subjects for all postintervention assessed items via the motivation questionnaire (all P<.001). Analysis of covariance (ANCOVA) revealed a significant difference in the confusion and bewilderment component in favor of the intervention group (P=.01), but only a trend toward significance in anger and hostility as well as total score. The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001). Finally, the intervention group subjects who were frequent users of the app showed stronger motivation, as well as increased perception of greater gains in their English-language competence, than did infrequent users.
CONCLUSIONS


The blended learning method led to significant improvements in motivation, mood state, and satisfaction compared to traditional teaching, and elicited statements of subjective improvement in terms of competence in English.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03335397; https://clinicaltrials.gov/ct2/show/NCT03335397.",2020,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","['undergraduate students enrolled in a health science first-degree program', 'A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group', 'Subjects who met the inclusion criteria', 'Undergraduate Students']","['intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning', 'Smartphone-based learning, or mobile learning (m-learning', 'blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app']","['knowledge, motivation, mood state, and satisfaction', 'Motivation, Mood State, and Satisfaction', 'anger and hostility', 'motivation questionnaire', 'increased perception of greater gains in their English-language competence', 'theoretical knowledge gain', 'multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence', 'motivation, mood state, and satisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}]",99.0,0.064006,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Noguerol', 'Affiliation': 'Departamento de Lenguajes y Sistemas Informáticos e Ingeniería de Software, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Cruz-Fernández', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Journal of medical Internet research,['10.2196/17101']
1948,32441736,Multiple object-tracking isolates feedback-specific load in attention and learning.,"Feedback is beneficial for learning. Nevertheless, it remains unclear whether (i) feedback draws attentional resources when integrated and (ii) the benefits of feedback for learning can be demonstrated using an attention-based task. We therefore (i) isolated feedback-specific load from task-specific load via individual differences in attention resource capacity and (ii) examined the effect of trial-by-trial feedback (i.e., present vs. absent) on learning a multiple object-tracking (MOT) paradigm. We chose MOT because it is a robust measure of attention resource capacity. In Study 1 participants tracked one (i.e., lowest attentional load condition) through four target items (i.e., highest load condition) among eight total items. One group (n = 32) received trial-by-trial feedback whereas the other group (n = 32) did not. The absence of feedback resulted in better MOT performance compared with the presence of feedback. Moreover, the difference in MOT capability between groups increased as the task-specific attentional load increased. These findings suggest that feedback integration requires attentional resources. Study 2 examined whether the absence (n = 19) or presence (n = 19) of feedback affects learning on the same MOT task across four testing days. When holding task-specific load constant, improvement in MOT was greater with feedback than without. Although this study is the first to isolate feedback-specific load in attention with MOT, more evidence is needed to demonstrate how the benefits of feedback translate to improvement on an attention-based task. These findings encourage future research to further explore the interaction between feedback, attention and learning.",2020,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.",[],[],"['MOT', 'task-specific attentional load', 'MOT capability', 'MOT performance']",[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",1.0,0.0317721,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.","[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tullo', 'Affiliation': ',.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Perico', 'Affiliation': ',.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Faubert', 'Affiliation': ',.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Bertone', 'Affiliation': ',.'}]",Journal of vision,['10.1167/jov.20.5.9']
1949,31246132,Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis.,"BACKGROUND


Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache.
METHODS


Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2-4 to 0 for ACT2.
RESULTS


The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype ( p  < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints  p  < 0.01). Only four patients discontinued the studies due to adverse events.
CONCLUSIONS


nVNS is a well-tolerated and effective acute treatment for episodic cluster headache.
TRIAL REGISTRATION


The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).",2019,nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints  p  < 0.01).,"['episodic and chronic cluster headache', '225 participants (episodic: n\u2009=\u2009112; chronic: n\u2009=\u2009113) from ACT1 (n\u2009=\u2009133) and ACT2 (n\u2009=\u200992) in the nVNS (n\u2009=\u2009108) and sham (n\u2009=\u2009117) groups']","['sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS', 'non-invasive vagus nerve stimulation']","['chronic cluster headache', 'pain intensity']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",225.0,0.234538,nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints  p  < 0.01).,"[{'ForeName': 'Ilse F', 'Initials': 'IF', 'LastName': 'de Coo', 'Affiliation': '1 Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Juana Ca', 'Initials': 'JC', 'LastName': 'Marin', 'Affiliation': ""2 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': '3 Department of Neurology, Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': '4 Department of Neurology, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': '5 Migraine and Headache Clinic, Königstein, Germany.'}, {'ForeName': 'Candace K', 'Initials': 'CK', 'LastName': 'McClure', 'Affiliation': '6 North American Science Associates Inc., Minneapolis, MN, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': '7 Neurology Department, The Southern Hospital, Glasgow, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Liebler', 'Affiliation': '8 electroCore, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': '9 Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': '1 Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""2 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419856607']
1950,32441759,A smartphone game to prevent HIV among young Kenyans: local perceptions of mechanisms of effect.,"Electronic games delivered via smartphones have the potential to become valuable tools in HIV prevention in high-prevalence and low-resource international settings. To ground theoretical elaboration around novel mHealth interventions in contextual realities, it is important to understand the mechanisms of their effects as perceived by local populations. Such perspectives are particularly important when working cross-culturally. 'Tumaini' is an interactive narrative-based smartphone game that uses a 'choose-your-own-adventure' format. It is designed to prevent HIV among young African adolescents (aged 11-14) by increasing age and condom use at first sex. It was developed with a US-based commercial game developer and is grounded in social behavioral theory, evidence-based practice and contextually relevant scenarios. In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut. In subsequent focus group discussions, adolescent participants and their parents shared their perceptions of the game's mechanisms of effect, which included motivation to play, future orientation, decision-making, relationship to a diverse range of characters and a bridging of the virtual and real worlds. These findings align with our theoretical framework, confirm its successful translation into the intervention and will inform mediation analyses in an upcoming efficacy trial.",2020,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[""2017 randomized pilot study (n\u2009=\u200960) in Western Kenya, 'Tumaini"", 'young African adolescents (aged 11-14) by increasing age and condom use at first sex']",[],['behavioral mediators of sexual debut'],"[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0581283,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Winskell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sabben', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Akelo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""Ondeng'e"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Odero', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mudhune', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}]",Health education research,['10.1093/her/cyaa011']
1951,31439467,Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial.,"RATIONALE AND OBJECTIVES


To compare the magnitude and interpatient variability in normalized mean hepatic enhancement (MHE) indices when dosing contrast media (CM) according to total body weight (TBW) and lean body weight (LBW).
MATERIALS AND METHODS


This ethics-approved stratified randomized controlled study allocated 280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables. CTs were acquired in portal venous phase after fixed 35-second injection of Iohexol 350. Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded. The number of included patients and CM doses were: TBW arm, 51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW. Liver attenuations were obtained from regions of interest. Values and standard deviations in MHE indices normalized to iodine dose (MHE/I) and iodine dose per kg TBW (aMHE = MHE/[I/TBW]) were compared (unpaired t tests and F-tests).
RESULTS


Cohorts were similar in age, sex, TBW, and LBW. TBW groups received more CM than LBW groups: men, 106.5 ± 20 versus 98.4 ± 11 mL, p = 0.007; women, 93.7 ± 20 versus 77.5 ± 11 mL, p < 0.0001. TBW and LBW groups showed no significant difference in MHE/I (women, 1.75 ± 0.5 versus 1.86 ± 0.6 HU/g, p = 0.31; men, 1.53 ± 0.4 versus 1.52 ± 0.4 HU/g, p = 0.90) or aMHE (women, 0.03 ± 0.01 versus 0.03 ± 0.01 HU/g/kg, p = 0.25; men, 0.02 ± 0.01 versus 0.02 ± 0.01 HU/g/kg, p = 0.52). Variances in MHE/I and aMHE were not significantly different for all groups (p > 0.05).
CONCLUSION


TBW- and LBW-based CM dosing yield a similar magnitude and interpatient variability in normalized MHE indices at routine abdominal CT.",2020,"I and aMHE were not significantly different for all groups (p > 0.05).
","['51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW', 'Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded', '280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables']","['Iohexol', 'Dosing Iodinated Contrast Media']",['total body weight (TBW) and lean body weight (LBW'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517510', 'cui_str': '1.66 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1706074', 'cui_str': 'Table'}]","[{'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",280.0,0.107393,"I and aMHE were not significantly different for all groups (p > 0.05).
","[{'ForeName': 'Andreu F', 'Initials': 'AF', 'LastName': 'Costa', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda. Electronic address: andreufcosta@gmail.com.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Peet', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdolell', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}]",Academic radiology,['10.1016/j.acra.2019.07.014']
1952,32441760,"A peer navigation intervention to prevent HIV among mixed immigrant status Latinx GBMSM and transgender women in the United States: outcomes, perspectives and implications for PrEP uptake.","The Latinx population in the United States is disproportionately affected by HIV. Our community-based participatory research partnership developed, implemented and evaluated a Spanish-language peer navigation intervention designed to increase HIV testing and condom use among social networks of immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW). We randomized 21 social networks of Latinx GBMSM and TW, ages 18-55 years, to the intervention, known as HOLA, or a waitlist control group. Social network participants (n = 166) completed structured assessments at baseline and 12-month follow-up (24 months after baseline). Follow-up retention was 95%. Individual in-depth interviews with a sample of participants documented their intervention-related experiences, needs, and priorities to inform future research. At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001). All study participants reported increased condom use; there was no significant difference between HOLA and waitlist control participants. In-depth interviews identified critical intervention elements and impacts and community needs and priorities. The HOLA intervention is effective for increasing HIV testing among Latinx GBMSM and TW, an initial step within the HIV prevention and care continua, and may be adaptable to promote pre-exposure prophylaxis uptake.",2020,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","['Social network participants (n\u2009=\u2009166', 'immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW']","['HOLA intervention', 'peer navigation intervention']",['HIV testing'],"[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",21.0,0.0335094,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rhodes', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alonzo', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Lilli', 'Initials': 'L', 'LastName': 'Mann-Jackson', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eunyoung Y', 'Initials': 'EY', 'LastName': 'Song', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Tanner', 'Affiliation': 'Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smart', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Logan S', 'Initials': 'LS', 'LastName': 'Baker', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Rosenau Hall, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}]",Health education research,['10.1093/her/cyaa010']
1953,31436835,Determinants of left atrium thrombi in scheduled cardioversion: an ENSURE-AF study analysis.,"AIMS


ENSURE-AF (NCT02072434) was the largest prospective randomized clinical trial of anticoagulation for cardioversion in atrial fibrillation (AF), which also provides the largest prospective dataset for transoesophageal echocardiography (TOE) prior to cardioversion. This ancillary analysis investigated determinants of TOE-detected left atrium thrombi (LAT) in patients scheduled for electrical cardioversion (ECV).
METHODS AND RESULTS


The ENSURE-AF multicentre PROBE evaluation trial compared edoxaban 60 mg once daily (QD) with enoxaparin/warfarin in 2199 subjects undergoing ECV of non-valvular AF. Patients were stratified by the use of TOE, anticoagulant experience, and selected edoxaban dose. Electrical cardioversion was cancelled or deferred when TOEdetected LAT. In total, 1183 subjects were stratified to the TOE arm and LAT was reported in 91 (8.2%). In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group. Non-significant trends were seen for higher mean CHA2DS2-VASc score (3.0 ± 1.41 vs. 2.7 ± 1.48, P = 0.0571) and more prevalent anticoagulation use prior to enrolment (60.4% vs. 50.3%, P = 0.0795) in the LAT group. In logistic regression analysis, age (P = 0.0202) and heart failure (P = 0.0064) were independently associated with LAT.
CONCLUSION


Elective ECV is commonly cancelled or deferred due to TOE-detected LAT in patients with non-valvular AF. Age ≥75 years and heart failure were associated with the presence of LAT.",2019,"In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group.","['scheduled cardioversion', '2199 subjects undergoing ECV of non-valvular AF', '1183 subjects', 'atrial fibrillation (AF', 'patients with non-valvular AF', 'patients scheduled for electrical cardioversion (ECV']","['TOE-detected left atrium thrombi (LAT', 'edoxaban', 'enoxaparin/warfarin']","['lower weight', 'Electrical cardioversion', 'heart failure', 'lower creatinine clearance', 'higher mean CHA2DS2-VASc score']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0376784', 'cui_str': 'Atrium (drug)'}, {'cui': 'C0023979', 'cui_str': 'LATS'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4049268', 'cui_str': 'CHA2DS2-VASc score'}]",1183.0,0.0354678,"In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group.","[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Arrhythmia and Robotic Electrophysiology Unit, Hospital Universitario La Paz, IDIPaz, Departamento de Medicina de la Universidad Autonoma de Madrid, P. Castellana, 261 (H. Gral, 1st Floor), Madrid, Spain.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbuchel', 'Affiliation': 'Department of Cardiology, Antwerp University and University Hospital, Wijlrijkstraat 10, Antwerp, Edegem, Belgium.'}, {'ForeName': 'Aron-Ariel', 'Initials': 'AA', 'LastName': 'Cohen', 'Affiliation': 'Service de cardiologie, INSERM 856 and Hôpital Saint Antoine, Hôpital Tenon; Sorbonne-Université (Université Pierre et Marie Curie, Paris VI), 1 rue Victor Cousin, Paris, France.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Chair of Cardiology, University of Pisa and Cardiology Division, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Joris R', 'Initials': 'JR', 'LastName': 'de Groot', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Heart Center, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Ezekowitz', 'Affiliation': 'Department of Cardiovascular Medicine, Sidney Kimmel Jefferson Medical College at Thomas Jefferson University, 1025 Walnut St #100, Philadelphia, PA, USA; Lankenau Medical Center, 100 East Lancaster Avenue, Wynnewood, PA, USA and Bryn Mawr Hospital, 130 South Bryn Mawr Avenue Bryn Mawr, PA, USA.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Le Heuzey', 'Affiliation': 'Cardiology and Arrhythmology, Georges Pompidou Hospital, René Descartes University, 20 Rue Leblanc, Paris, France.'}, {'ForeName': 'Sakis', 'Initials': 'S', 'LastName': 'Themistoclakis', 'Affiliation': ""Unit of Electrophysiology and Cardiac Pacing, Dell'Angelo Hospital, Via Paccagnella, 11, Venice-Mestre, Italy.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo Pharma Development, 211 Mt Airy Rd, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Melino', 'Affiliation': 'Daiichi Sankyo Pharma Development, 211 Mt Airy Rd, Basking Ridge, NJ, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Winters', 'Affiliation': 'Daiichi Sankyo, Inc., 211 Mt Airy Rd, Basking Ridge, NJ, USA.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Városmajor u.68, Budapest, Hungary.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'St. Vincenz-Hospital, Paderborn, Am Busdorf 2, Paderborn, Nordrhein-Westfalen, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz213']
1954,31434537,Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial.,"Background . Children with unilateral spastic cerebral palsy (USCP) have strength, coordination, and balance deficits affecting gross motor skills, such as walking, running, and jumping. However, there is a paucity of evidence for effective treatments for lower-extremity (LE) function in children with USCP.  Objective . To determine the effectiveness of LE intensive functional training (LIFT) compared with an attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT]).  Methods . A total of 24 children with USCP were randomized to receive 90 hours of LIFT (5.8 [2.3] years) or an equivalent dosage of H-HABIT (5.1 [2.6] years) delivered 2 h/d, 5 d/wk for 9 weeks. Caregivers were trained to administer the intervention in the home setting. Progress and skill progression were monitored, and supervision was provided via weekly telerehabilitation. The primary outcome was the 1-minute walk test (1MWT). Secondary outcomes included self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance.  Results . LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls. The other secondary outcomes were not different between groups.  Conclusions . The administration of LE intensive interventions in the home setting by caregivers was shown to be an effective and novel mode of delivery for improving gait capacity and performance. LIFT delivered in the home setting using telerehabilitation for monitoring resulted in improvements in ambulation distance and overall walking ability as compared to an intervention of equal intensity and duration that also controlled for the increased social interaction and attention between caregiver and child.",2019,LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls.,"['Young Children With Unilateral Spastic Cerebral Palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', '24 children with USCP']","['attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT', 'LE intensive functional training (LIFT', 'Lower-Extremity Functional Training (LIFT', 'LE intensive interventions']","['ambulation distance and overall walking ability', '1-minute walk test (1MWT', 'self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance', '1MWT']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.11282,LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls.,"[{'ForeName': 'Bhavini K', 'Initials': 'BK', 'LastName': 'Surana', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Ferre', 'Affiliation': 'Burke Neurological Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Dew', 'Affiliation': 'Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Brandao', 'Affiliation': 'Department of Occupational Therapy and Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Noelle G', 'Initials': 'NG', 'LastName': 'Moreau', 'Affiliation': 'LSU Health Sciences Center, New Orleans, LA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968319868719']
1955,31435671,How to perform electroanatomic mapping-guided cardiac resynchronization therapy using Carto 3 and ESI NavX three-dimensional mapping systems.,"AIMS 


To examine the feasibility and safety of a novel protocol for low fluoroscopy, electroanatomic mapping (EAM)-guided Cardiac resynchronization therapy with a defibrillator (CRT-D) implantation and using both EnSite NavX (St. Jude Medical, St. Paul, MN, USA) and Carto 3 (Biosense Webster, Irvine, CA, USA) mapping systems.
METHODS AND RESULTS


Twenty consecutive patients underwent CRT implantation using either a conventional fluoroscopic approach (CFA) or EAM-guided lead placement with Carto 3 and EnSite NavX mapping systems. We compared fluoroscopy and procedural times, radiopaque contrast dose, change in QRS duration pre- and post-procedure, and complications in all patients. Fluoroscopy time was 86% lower in the EAM group compared to the conventional group [mean 37.2 min (CFA) vs. 5.5 min (EAM), P = 0.00003]. There was no significant difference in total procedural time [mean 183 min (CFA) vs. 161 min (EAM), P = 0.33] but radiopaque contrast usage was lower in the EAM group [mean 16 mL (CFA) vs. 4 mL (EAM), P = 0.006]. Likewise, there was no significant change in QRS duration with BiV pacing between the groups [mean -13 (CFA) vs. -25 ms (EAM), P = 0.09].
CONCLUSION 


Electroanatomic mapping-guided lead placement using either Carto or ESI NavX mapping systems is a feasible alternative to conventional fluoroscopic methods for CRT-D implantation utilizing the protocol described in this study.",2019,"Fluoroscopy time was 86% lower in the EAM group compared to the conventional group [mean 37.2 min (CFA) vs. 5.5 min (EAM), P = 0.00003].",['Twenty consecutive patients underwent'],"['electroanatomic mapping-guided cardiac resynchronization therapy', 'EAM', 'novel protocol for low fluoroscopy, electroanatomic mapping (EAM)-guided Cardiac resynchronization therapy with a defibrillator (CRT-D) implantation and using both EnSite NavX (St. Jude Medical, St. Paul, MN, USA', 'conventional fluoroscopic approach (CFA) or EAM-guided lead placement with Carto 3 and EnSite NavX mapping systems', 'CRT implantation']","['radiopaque contrast usage', 'QRS duration pre- and post-procedure, and complications', 'Fluoroscopy time', 'total procedural time', 'QRS duration with BiV pacing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]",20.0,0.0312683,"Fluoroscopy time was 86% lower in the EAM group compared to the conventional group [mean 37.2 min (CFA) vs. 5.5 min (EAM), P = 0.00003].","[{'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, 1717 W. Congress Parkway, Suite 332, Kellogg, Chicago, IL, USA.'}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, 1717 W. Congress Parkway, Suite 332, Kellogg, Chicago, IL, USA.'}, {'ForeName': 'Hemal M', 'Initials': 'HM', 'LastName': 'Nayak', 'Affiliation': 'Division of Cardiology, University of Chicago, 5758 S. Maryland Avenue M/C 9024, Chicago, IL, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Serafini', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, 1717 W. Congress Parkway, Suite 332, Kellogg, Chicago, IL, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Trohman', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, 1717 W. Congress Parkway, Suite 332, Kellogg, Chicago, IL, USA.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz229']
1956,31788233,"Use of mobile technology by frontline health workers to promote reproductive, maternal, newborn and child health and nutrition: a cluster randomized controlled Trial in Bihar, India.","Background


mHealth technology holds promise for improving the effectiveness of frontline health workers (FLWs), who provide most health-related primary care services, especially reproductive, maternal, newborn, child health and nutrition services (RMNCHN), in low-resource - especially hard-to-reach - settings. Data are lacking, however, from rigorous evaluations of mHealth interventions on delivery of health services or on health-related behaviors and outcomes.
Methods


The Information Communication Technology-Continuum of Care Service (ICT-CCS) tool was designed for use by community-based FLWs to increase the coverage, quality and coordination of services they provide in Bihar, India. It consisted of numerous mobile phone-based job aids aimed to improve key RMNCHN-related behaviors and outcomes. ICT-CCS was implemented in Saharsa district, with cluster randomization at the health sub-center level. In total, evaluation surveys were conducted with approximately 1100 FLWs and 3000 beneficiaries who had delivered an infant in the previous year in the catchment areas of intervention and control health sub-centers, about half before implementation (mid-2012) and half two years afterward (mid-2014). Analyses included bivariate and difference-in-difference analyses across study groups.
Results


The ICT-CCS intervention was associated with more frequent coordination of AWWs with ASHAs on home visits and greater job confidence among ASHAs. The intervention resulted in an 11 percentage point increase in FLW antenatal home visits during the third trimester ( P  = 0.04). In the post-implementation period, postnatal home visits during the first week were increased in the intervention (72%) vs the control (60%) group ( P  < 0.01). The intervention also resulted in 13, 12, and 21 percentage point increases in skin-to-skin care ( P  < 0.01), breastfeeding immediately after delivery ( P  < 0.01), and age-appropriate complementary feeding ( P  < 0.01). FLW supervision and other RMNCHN behaviors were not significantly impacted.
Conclusions


Important improvements in FLW home visits and RMNCHN behaviors were achieved. The ICT-CCS tool shows promise for facilitating FLW effectiveness in improving RMNCHN behaviors.",2019,"In the post-implementation period, postnatal home visits during the first week were increased in the intervention (72%) vs the control (60%) group ( P  < 0.01).","['In total, evaluation surveys were conducted with approximately 1100 FLWs and 3000 beneficiaries who had delivered an infant in the previous year in the catchment areas of intervention and control health sub-centers, about half before implementation (mid-2012) and half two years afterward (mid-2014']",['ICT-CCS'],"['FLW antenatal home visits', 'skin-to-skin care']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}]",[],"[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}]",,0.0365065,"In the post-implementation period, postnatal home visits during the first week were increased in the intervention (72%) vs the control (60%) group ( P  < 0.01).","[{'ForeName': 'Suzan L', 'Initials': 'SL', 'LastName': 'Carmichael', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Kala', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Srikantiah', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Tanmay', 'Initials': 'T', 'LastName': 'Mahapatra', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Indrajit', 'Initials': 'I', 'LastName': 'Chaudhuri', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Ramkrishnan', 'Initials': 'R', 'LastName': 'Balakrishnan', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Chaturvedi', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Raheel', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Borkum', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Shamik', 'Initials': 'S', 'LastName': 'Trehan', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Sivasankaran', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rotz', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Usha Kiran', 'Initials': 'UK', 'LastName': 'Tarigopula', 'Affiliation': 'India Country Office, Bill and Melinda Gates Foundation, Delhi, India.'}, {'ForeName': 'Debarshi', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'India Country Office, Bill and Melinda Gates Foundation, Delhi, India.'}, {'ForeName': 'Yamini', 'Initials': 'Y', 'LastName': 'Atmavilas', 'Affiliation': 'India Country Office, Bill and Melinda Gates Foundation, Delhi, India.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Pepper', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Rangarajan', 'Affiliation': 'Mathematica Policy Research, Princeton, New Jersey, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Darmstadt', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of global health,['10.7189/jogh.09.020424']
1957,31318460,Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2-positive advanced breast cancer: Final results from MARIANNE.,"BACKGROUND


In the phase 3 MARIANNE trial, trastuzumab emtansine (T-DM1) with or without pertuzumab showed noninferior progression-free survival and better tolerability than trastuzumab plus a taxane (HT) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. This article reports the final descriptive overall survival (OS) analysis, updated safety data, and additional patient-reported outcomes and biomarker analyses.
METHODS


OS was assessed in 1095 patients with HER2-positive breast cancer and no prior therapy for advanced disease who had been randomized to HT, T-DM1 plus a placebo (hereafter T-DM1), or T-DM1 plus pertuzumab (T-DM1+pertuzumab). A post hoc exploratory landmark analysis of OS, baseline patient and disease characteristics, and tumor biomarkers in patients with and without an objective tumor response (OR) according to the Response Evaluation Criteria in Solid Tumors within 6.5 months of randomization was conducted.
RESULTS


The median OS was similar across groups (50.9, 53.7, and 51.8 months for the HT, T-DM1, and T-DM1+pertuzumab groups, respectively). Among patients with an OR, the median OS was longer with T-DM1 (64.4 months) and T-DM1+pertuzumab (not reached) versus HT (56.3 months). No baseline characteristics or biomarkers were strongly associated with OR. The incidence of grade 3 or higher adverse events was greater with HT (55.8%) than T-DM1 (47.1%) or T-DM1+pertuzumab (48.6%). The median time to clinically meaningful deterioration (a 3-point or greater change) in neurotoxicity symptoms was shorter with HT (2.1 months) and T-DM1+pertuzumab (4.2 months) than T-DM1 (6.2 months). Fewer patients reported alopecia and diarrhea and were bothered by treatment side effects in the T-DM1 arm.
CONCLUSIONS


These results support T-DM1 as a first-line treatment for patients with HER2-positive metastatic breast cancer who are deemed unsuitable for taxane-based therapy.",2019,"Fewer patients reported alopecia and diarrhea and were bothered by treatment side effects in the T-DM1 arm.
","['human epidermal growth factor receptor 2', 'HER2)-positive advanced breast cancer', 'human epidermal growth factor receptor 2-positive advanced breast cancer', '1095 patients with HER2-positive breast cancer and no prior therapy for advanced disease who had been randomized to', 'patients with HER2-positive metastatic breast cancer who are deemed unsuitable for taxane-based therapy', 'patients with and without an objective tumor response (OR) according to the Response Evaluation Criteria in Solid Tumors within 6.5\xa0months of randomization was conducted']","['HT, T-DM1 plus a placebo (hereafter T-DM1), or T-DM1 plus pertuzumab (T-DM1+pertuzumab', 'trastuzumab plus a taxane (HT', 'Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane']","['neurotoxicity symptoms', 'median time to clinically meaningful deterioration', 'median OS', 'alopecia and diarrhea', 'noninferior progression-free survival and better tolerability', 'incidence of grade 3 or higher adverse events']","[{'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}]","[{'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1095.0,0.0550275,"Fewer patients reported alopecia and diarrhea and were bothered by treatment side effects in the T-DM1 arm.
","[{'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Interdisciplinary Oncology Center, Munich, Germany.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'University of Padua, Padua, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Complutense University, CIBERONC, GEICAM, Madrid, Spain.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Pienkowski', 'Affiliation': 'Postgraduate Medical Education Center, Warsaw, Poland.'}, {'ForeName': 'Xavier B', 'Initials': 'XB', 'LastName': 'Pivot', 'Affiliation': 'Centre Paul Strauss, INSERM U1109, Strasbourg, France.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'De Haas', 'Affiliation': 'F. Hoffmann-La Roche, Ltd, Basel, Switzerland.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hoersch', 'Affiliation': 'F. Hoffmann-La Roche, Ltd, Basel, Switzerland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Patre', 'Affiliation': 'F. Hoffmann-La Roche, Ltd, Basel, Switzerland.'}, {'ForeName': 'Paul Anthony', 'Initials': 'PA', 'LastName': 'Ellis', 'Affiliation': ""Guy's Hospital and Sarah Cannon Research Institute, London, United Kingdom.""}]",Cancer,['10.1002/cncr.32392']
1958,31432311,Anti-infective therapy of peri-implant mucositis with adjunctive delivery of a sodium hypochlorite gel: a 6-month randomized triple-blind controlled clinical trial.,"OBJECTIVE


To evaluate the effects of adjunctive delivery of a sodium hypochlorite gel in the treatment of peri-implant mucositis (PM).
MATERIALS AND METHODS


Forty-six subjects with 68 implants diagnosed with PM were randomly assigned to two treatment groups. Prior to mechanical debridement, a sodium hypochlorite gel was delivered to the implants of the test group while implants of the control group received a placebo gel. Application of both test and placebo gels was repeated 5 times at baseline. The primary outcome variable was the change in pocket probing depth (PPD) between baseline and 6 months.
RESULTS


After 6 months, the mean PPD decreased statistically significantly from 3.93 ± 1.09 mm to 3.04 ± 0.46 mm in the test (p = 0.0001) and from 3.68 ± 0.85 mm to 3.07 ± 0.58 mm in the control (p = 0.0001) group, respectively. No statistically significant difference (p = 0.53) was observed with respect to PPD changes from baseline to 6 months between test (0.88 ± 1.04 mm) and control group (0.61 ± 0.75 mm), respectively. The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
CONCLUSIONS


In conclusion and within the limits of the present study, changes in PPD from baseline to 6 months were not statistically significantly different between groups. Complete resolution of mucosal inflammation was not achieved with either of the therapies.
CLINICAL RELEVANCE


The present outcomes have showed that a complete resolution of peri-implant mucositis is not possible to obtain by means mechanical debridement with or without a sodium hypochlorite gel application.",2020,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","['peri-implant mucositis (PM', 'Forty-six subjects with 68 implants diagnosed with PM']","['placebo', 'placebo gel', 'sodium hypochlorite gel']","['mean PPD', 'PPD changes', 'Complete resolution of mucosal inflammation', 'change in pocket probing depth (PPD', 'number of implants with bleeding on probing (BoP']","[{'cui': 'C3698407', 'cui_str': 'Dental peri-implant mucositis (disorder)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}]",46.0,0.138324,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Stefan-Ioan', 'Initials': 'SI', 'LastName': 'Stratul', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Darian', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}]",Clinical oral investigations,['10.1007/s00784-019-03060-2']
1959,31431562,Impact of Advanced Patient Counseling Using a Training Device and Smartphone Application on Asthma Control.,"BACKGROUND


Pressurized metered-dose inhalers (pMDIs) are among the most commonly used aerosol delivery devices. Poor lung deposition from a pMDI is often a result of incorrect inhalation technique. The aim of this study was to compare the impact of combining a newly released training device with a smartphone application (advanced counseling) in asthma control to the impact of traditional verbal training.
METHODS


A total of 371 subjects with asthma were divided into 2 groups: advanced counseling ( n  = 187) and verbal counseling ( n  = 184). Both groups had 3 visits, each meeting being a month apart. At each visit, lung function (ie, FEV 1 , ratio of FEV 1  to forced vital capacity [FEV 1 /FVC], and peak expiratory flow) were measured, an asthma control test was given, and subjects were trained in the correct inhalation technique. Inhalation flow through the pMDI was also recorded at each visit because the correct pMDI technique requires an inspiratory flow of < 60 L/min.
RESULTS


In the advanced counseling group, lung function significantly improved after both the first and the second visit ( P  < .001), whereas in the verbal group, lung function improved significantly only after the second visit ( P  < .001). Although the inspiratory flow through the pMDI improved significantly in both groups, it was closest to the target range in the advanced counseling group. In addition, more subjects in the advanced counseling group had monthly increases of ≥ 3 points in their asthma control test scores compared to the verbal counseling group.
CONCLUSIONS


The use of a training device with a smartphone application in conjunction with traditional verbal counseling in pMDI technique resulted in significant improvements in asthma control compared to traditional verbal counseling in pMDI technique alone.",2020,"In the advanced counseling group, lung function significantly improved after both the first and the second visit ( P  < .001), whereas in the verbal group, lung function improved significantly only after the second visit ( P  < .001).",['371 subjects with asthma'],"['traditional verbal training', 'newly released training device with a smartphone application (advanced counseling', 'advanced counseling', 'verbal counseling', 'Advanced Patient Counseling Using a Training Device and Smartphone Application']","['inspiratory flow through the pMDI', 'lung function (ie, FEV 1 , ratio of FEV 1  to forced vital capacity [FEV 1 /FVC], and peak expiratory flow', 'lung function']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",371.0,0.0214137,"In the advanced counseling group, lung function significantly improved after both the first and the second visit ( P  < .001), whereas in the verbal group, lung function improved significantly only after the second visit ( P  < .001).","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Saeed', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-suef University, Beni-suef, Egypt.'}, {'ForeName': 'Mohamed Ea', 'Initials': 'ME', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-suef University, Beni-suef, Egypt. mohamedemam9@yahoo.com.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-suef University, Beni-suef, Egypt.'}, {'ForeName': 'Heba F', 'Initials': 'HF', 'LastName': 'Salem', 'Affiliation': 'Pharmaceutics and Industrial Pharmacy Department, Beni-suef University, Beni-suef, Egypt.'}]",Respiratory care,['10.4187/respcare.06903']
1960,31609286,"Knowledge and Skills Acquisition by Plastic Surgery Residents through Digital Simulation Training: A Prospective, Randomized, Blinded Trial.","BACKGROUND


Simulation is a standard component of residency training in many surgical subspecialties, yet its impact on knowledge and skills acquisition in plastic surgery training remains poorly defined. The authors evaluated the potential benefits of simulation-based cleft surgery learning in plastic surgery resident education through a prospective, randomized, blinded trial.
METHODS


Thirteen plastic surgery residents were randomized to a digital simulator or textbook demonstrating unilateral cleft lip repair. The following parameters were evaluated before and after randomization: knowledge of surgical steps, procedural confidence, markings performance on a three-dimensional stone model, and surgical performance using a hands-on/high-fidelity three-dimensional haptic model. Participant satisfaction with either educational tool was also assessed. Two expert reviewers blindly graded markings and surgical performance. Intraclass correlation coefficients were calculated. Wilcoxon signed rank and Mann-Whitney U tests were used.
RESULTS


Interrater reliability was strong for preintervention and postintervention grading of markings [preintervention intraclass correlation coefficient, 0.97 (p < 0.001); postintervention intraclass correlation coefficient, 0.96 (p < 0.001)] and surgical [preintervention intraclass correlation coefficient, 0.83 (p = 0.002); postintervention intraclass correlation coefficient, 0.81 (p = 0.004)] performance. Postintervention surgical knowledge (40.3 ± 4.4 versus 33.5 ± 3.7; p = 0.03), procedural confidence (24.0 ± 7.0 versus 14.7 ± 2.3; p = 0.03), markings performance (8.0 ± 2.5 versus 2.9 ± 3.1; p = 0.03), and surgical performance (12.3 ± 2.5 versus 8.2 ± 2.3; p = 0.04) significantly improved in the digital simulation group compared with before intervention, but not in the textbook group. All participants were more satisfied with the digital simulator as an educational tool (27.7 ± 2.5 versus 14.4 ± 4.4; p < 0.001).
CONCLUSION


The authors present evidence suggesting that digital cognitive simulators lead to significant improvement in surgical knowledge, procedural confidence, markings performance, and surgical performance.",2020,"All participants were more satisfied with the digital simulator as an educational tool (27.7±2.5 vs. 14.4±4.4; p<0.001).
","['plastic surgery resident education', 'Thirteen plastic surgery residents', 'Plastic Surgery Residents Through Digital Simulation Training']","['simulation-based cleft surgery learning', 'digital simulator or textbook demonstrating unilateral cleft lip (UCL) repair']","['surgical performance ', 'procedural confidence', 'markings performance', 'surgical knowledge, procedural confidence, markings performance, as well as surgical performance', 'Intra-class correlation coefficients (ICC']","[{'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0392006'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.0954146,"All participants were more satisfied with the digital simulator as an educational tool (27.7±2.5 vs. 14.4±4.4; p<0.001).
","[{'ForeName': 'Rami S', 'Initials': 'RS', 'LastName': 'Kantar', 'Affiliation': 'New York, N.Y. From the Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health.'}, {'ForeName': 'Allyson R', 'Initials': 'AR', 'LastName': 'Alfonso', 'Affiliation': ''}, {'ForeName': 'Elie P', 'Initials': 'EP', 'LastName': 'Ramly', 'Affiliation': ''}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Rifkin', 'Affiliation': ''}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Maliha', 'Affiliation': ''}, {'ForeName': 'J Rodrigo', 'Initials': 'JR', 'LastName': 'Diaz-Siso', 'Affiliation': ''}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Eisemann', 'Affiliation': ''}, {'ForeName': 'Pierre B', 'Initials': 'PB', 'LastName': 'Saadeh', 'Affiliation': ''}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Flores', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006375']
1961,32438043,Optimizing the Conditioning Regimen for HCT in Myelofibrosis: Long-term Results of a Prospective Phase II Clinical Trial.,"BACKGROUND


Optimal conditioning regimen for older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplantation (HCT) is not known. Likewise, role of dose intensity is not clear.
METHODS


We conducted a non-randomized prospective phase II trial using low-dose, later escalated to high-dose (MAC) busulfan with fludarabine (Bu-Flu) in myelofibrosis patients up to 74 years. First 15 patients received intravenous busulfan 130 mg/m 2 /day on days -3 and -2 (""low dose""); 31 received high dose - either 100 mg/m 2 /day (days -5 to -2; n=4) or pharmacokinetic-guided area under the curve of 4,000 μmol.min (days -5 to -2; n=27). Primary endpoint was day 100 non-relapse mortality (NRM).
FINDINGS


Median age was 58 years (interquartile range (IQR) 53-63). Dynamic international prognostic scoring system (DIPSS)-plus was intermediate (n=28) or high (n=18). Donors were related (n=19) or unrelated (n=27). Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years. With a median follow up of 5.1 years (IQR 3.8-6), 3-year relapse was 32.3% (95% CI 15.4-49.1) in high dose versus 53.3% (95% CI 26.6-80.1) in low dose; event-free survival was 58% (95% CI 43-78%) versus 27% (95% CI 12-62%), and overall survival was 74% (95% CI 60-91%) versus 60% (95% CI 40-91%) respectively. In multivariate analysis, high dose busulfan had a trend towards lower relapse (Hazard ratio (HR) 0.44, 95% CI, 0.18-1.07, p=0.07), with no impact on NRM.
INTERPRETATION


Intensifying Bu-Flu regimen using pharmacokinetic-monitoring appears promising in reducing relapse without increasing non-relapse mortality.
FUNDING


The study was supported partly by Otsuka pharmaceutical and partly by the Cancer Center Support Grant (NCI Grant P30 CA016672).",2020,"Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years.","['older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplantation (HCT', 'Median age was 58 years (interquartile range (IQR) 53-63', 'Donors were related (n=19) or unrelated (n=27', 'myelofibrosis patients up to 74 years']","['later escalated to high-dose (MAC) busulfan with fludarabine (Bu-Flu', 'intravenous busulfan']","['lower relapse (Hazard ratio (HR', 'overall survival', 'free survival', 'Cumulative incidence of NRM', '3-year relapse', 'day 100 non-relapse mortality (NRM']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.306467,"Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years.","[{'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Popat', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. Electronic address: upopat@mdanderson.org.'}, {'ForeName': 'Rohtesh S', 'Initials': 'RS', 'LastName': 'Mehta', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bassett', 'Affiliation': 'Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Piyanuch', 'Initials': 'P', 'LastName': 'Kongtim', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA; Division of Hematology Department of Internal Medicine Faculty of Medicine Thammasat University, Thailand.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Anderlini', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ciurea', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Hosing', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Khouri', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard Lindsay', 'Initials': 'RL', 'LastName': 'Pa', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yago', 'Initials': 'Y', 'LastName': 'Nieto', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Olson', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Oran', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rondon', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Borje S', 'Initials': 'BS', 'LastName': 'Andersson', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Champlin', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.03.020']
1962,32437507,Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.,"Importance


Clinical outcomes for glioblastoma remain poor. Treatment with immune checkpoint blockade has shown benefits in many cancer types. To our knowledge, data from a randomized phase 3 clinical trial evaluating a programmed death-1 (PD-1) inhibitor therapy for glioblastoma have not been reported.
Objective


To determine whether single-agent PD-1 blockade with nivolumab improves survival in patients with recurrent glioblastoma compared with bevacizumab.
Design, Setting, and Participants


In this open-label, randomized, phase 3 clinical trial, 439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized. Patients were enrolled between September 2014 and May 2015. The median follow-up was 9.5 months at data cutoff of January 20, 2017. The study included 57 multicenter, multinational clinical sites.
Interventions


Patients were randomized 1:1 to nivolumab 3 mg/kg or bevacizumab 10 mg/kg every 2 weeks until confirmed disease progression, unacceptable toxic effects, or death.
Main Outcomes and Measures


The primary end point was overall survival (OS).
Results


A total of 369 patients were randomized to nivolumab (n = 184) or bevacizumab (n = 185). The MGMT promoter was methylated in 23.4% (43/184; nivolumab) and 22.7% (42/185; bevacizumab), unmethylated in 32.1% (59/184; nivolumab) and 36.2% (67/185; bevacizumab), and not reported in remaining patients. At median follow-up of 9.5 months, median OS (mOS) was comparable between groups: nivolumab, 9.8 months (95% CI, 8.2-11.8); bevacizumab, 10.0 months (95% CI, 9.0-11.8); HR, 1.04 (95% CI, 0.83-1.30); P = .76. The 12-month OS was 42% in both groups. The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%). Grade 3/4 treatment-related adverse events (TRAEs) were similar between groups (nivolumab, 33/182 [18.1%]; bevacizumab, 25/165 [15.2%]), with no unexpected neurological TRAEs or deaths due to TRAEs.
Conclusions and Relevance


Although the primary end point was not met in this randomized clinical trial, mOS was comparable between nivolumab and bevacizumab in the overall patient population with recurrent glioblastoma. The safety profile of nivolumab in patients with glioblastoma was consistent with that in other tumor types.
Trial Registration


ClinicalTrials.gov Identifier: NCT02017717.",2020,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","['patients with recurrent glioblastoma compared with bevacizumab', '439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized', '369 patients', 'patients with glioblastoma', 'Patients With Recurrent Glioblastoma', 'Patients were enrolled between September 2014 and May 2015', '57 multicenter, multinational clinical sites']","['nivolumab', 'immune checkpoint blockade', 'nivolumab 3 mg/kg or bevacizumab', 'Nivolumab vs Bevacizumab', 'bevacizumab']","['safety profile of nivolumab', 'survival', 'median OS (mOS', 'Grade 3/4 treatment-related adverse events (TRAEs', 'objective response rate', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",439.0,0.244696,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'AUSL-IRCCS Institute of Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Omuro', 'Affiliation': 'Department of Neurology and Yale Cancer Center, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulholland', 'Affiliation': 'University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Baehring', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Manmeet S', 'Initials': 'MS', 'LastName': 'Ahluwalia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Phuphanich', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'De Souza', 'Affiliation': 'University of Wollongong School of Medicine, Wollongong, NSW, Australia.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Sahebjam', 'Affiliation': 'Moffitt Cancer Center, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Carleton', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tatsuoka', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Taitt', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Zwirtes', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1024']
1963,31425468,Ketamine infusion for pain control in elderly patients with multiple rib fractures: Results of a randomized controlled trial.,"BACKGROUND


Rib fractures are associated with increased mortality, particularly in the elderly. While opiate-based pain regimens remain the cornerstone of rib fracture management, issues related to opioids have driven research into alternative analgesics. Adjunctive ketamine use in lieu of opioids continues to increase but little evidence exists to support its efficacy or safety within the elderly trauma population.
METHODS


A prospective, randomized, double-blind placebo-controlled trial of elderly patients (age, ≥65 years) with three or more rib fractures admitted to a Level I trauma center was conducted. Exclusion criteria included Glasgow Coma Scale score less than 14, and chronic opiate use. Groups were randomized to either low-dose ketamine (LDK) at 2 μg·kg·min or an equivalent rate of 0.9% normal saline. The primary outcome was reduction in numeric pain scores (NPS). Secondary outcomes included oral morphine equivalent (OME) utilization, epidural rates, pulmonary complications, and adverse events.
RESULTS


Thirty (50.8%) of 59 were randomized to the experimental arm. Groups were similar in makeup. Low-dose ketamine failed to reduce 24-hour NPS or OME totals. Subgroup analysis of 24 patients with Injury Severity Score greater than 15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 mg vs. 42.6 mg, p = 0.04) but at no other time points. No difference in other secondary outcomes or adverse events was noted.
CONCLUSION


Low-dose ketamine failed to affect NPS or OME within the overall cohort, but a decrease in OME was observed in those with an Injury Severity Score greater than 15. Additional studies are necessary to confirm whether LDK benefits severely injured elderly patients.
LEVEL OF EVIDENCE


Therapeutic, level I.",2019,"Subgroup analysis of 24 patients with ISS >15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 vs. 42.6mg, p=0.04) but at no other time points.","['benefits severely injured elderly patients', 'elderly patients (age ≥65) with ≥3 rib fractures admitted to a Level 1 trauma center was conducted', 'Thirty of 59 (50.8', 'Elderly Patients with Multiple Rib Fractures']","['placebo', 'Ketamine', 'ketamine (LDK', 'ketamine', 'LDK']","['OME', 'adverse events', 'oral morphine equivalent (OME) utilization, epidural rates, pulmonary complications, and adverse events', 'numeric pain scores (NPS', 'OME utilization', '24-hour NPS or OME totals', 'NPS or OME']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.314311,"Subgroup analysis of 24 patients with ISS >15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 vs. 42.6mg, p=0.04) but at no other time points.","[{'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Kugler', 'Affiliation': 'From the Division of Trauma and Acute Care Surgery, Department of Surgery (N.W.K., T.W.C., W.J.P., K.B., L.B.S.), Medical College of Wisconsin, Milwaukee; Division of Critical Care Pharmacy, Department of Pharmacy, (J.J.), Froedtert Memorial Lutheran Hospital, Wauwatosa; Division of Regional Anesthesia and Acute Pain Management, Department of Anesthesia (K.M.D.), Division of Biostatistics (A.S., L.R.), Medical College of Wisconsin, Milwaukee, Wisconsin; Division of General Surgery, Department of Surgery, (J.S.P.), University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Carver', 'Affiliation': ''}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Peppard', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Karin Madsen', 'Initials': 'KM', 'LastName': 'Drescher', 'Affiliation': ''}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rein', 'Affiliation': ''}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Somberg', 'Affiliation': ''}, {'ForeName': 'Jasmeet S', 'Initials': 'JS', 'LastName': 'Paul', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002479']
1964,31402008,Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.,"BACKGROUND


There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries.
METHODS


We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849.
FINDINGS


Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia.
INTERPRETATION


Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective.
FUNDING


UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.",2019,There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided.,"['pelvic infection after miscarriage surgery', 'miscarriage in Malawi, Pakistan, Tanzania, and Uganda', 'Between June 2, 2014, and April 26, 2017, 3412 women', '3412 women recruited to the AIMS trial', 'miscarriage in low-income countries']","['placebo', 'antibiotic prophylaxis', 'Antibiotic prophylaxis']","['pelvic infection', 'Pelvic infection']","[{'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}]",3412.0,0.42792,There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided.,"[{'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lissauer', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'School of Health Sciences, University of Nottingham, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Middleton', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Weeks', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Chisale', 'Initials': 'C', 'LastName': 'Mhango', 'Affiliation': 'College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mataya', 'Affiliation': 'College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.'}, {'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'The Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan.'}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': 'UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Hospital Universitario Ramón y Cajal, CIBER en Epidemiología y Salud Pública (CIBERESP) and Instituto de Investigación Sanitaria (IRYCIS), Madrid, Spain.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. Electronic address: t.e.roberts@bham.ac.uk.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30336-5']
1965,31298632,Effects of E-cigarette Advertising Message Form and Cues on Cessation Intention: An Exploratory Study.,"A common message in e-cigarette advertising is that e-cigarettes can be used anywhere. E-cigarette advertisements often express this message implicitly (e.g., ""Whenever, wherever"") alongside images of e-cigarettes that physically resemble combustible cigarettes. These implicit messages and ""cigalike"" images may cross-cue combustible cigarette smoking cognitions and behavior. This exploratory study was a 2 (message form: implicit or explicit e-cigarette use anywhere message) by 2 (presence or absence of e-cigarette cue) experiment with U.S. adult smokers (n = 2,201). Participants were randomized to view e-cigarette advertisements that varied by study condition. Three combustible cigarette outcomes were investigated: smoking cessation intention, smoking urges, and immediate smoking behavior. Mediation analysis was also performed to investigate mechanisms of the message form effect through descriptive and normative beliefs about smoking. Compared to its explicit counterpart, the implicit e-cigarette use anywhere message evoked greater smoking urges. Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention. There was no evidence of e-cigarette cue or message form × cue interaction effects. Implicit e-cigarette use anywhere messages may create a predisposition towards smoking compared to their explicitly written counterparts, but whether this effect undermines cessation deserves further attention.",2019,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.",[],['E-cigarette Advertising Message Form and Cues'],"['smoking cessation intention, smoking urges, and immediate smoking behavior', 'Cessation Intention']",[],"[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",,0.012925,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jo', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'b School of Media and Journalism, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1639857']
1966,32438301,Preoperative fasting abbreviation (Enhanced Recovery After Surgery protocol) and its effects on the metabolism of patients undergoing gynecologic surgeries under spinal anesthesia: A randomized clinical trial.,"OBJECTIVES


Recommended perioperative nutritional interventions may contribute to satisfactory surgical outcomes. Each moment in the course of a surgical pathologic condition may be a window of opportunity for an intervention with a positive impact on postoperative recovery. Based on the idea of accelerating postoperative recovery, the objective of this study was to evaluate the effectiveness of a nutritional intervention with preoperative fasting abbreviation (Enhanced Recovery After Surgery recommendations) on the metabolism of patients undergoing gynecologic surgeries under spinal anesthesia.
METHODS


This randomized clinical trial was performed at a hospital of medium complexity. After Human Research Ethics Committee approval on August 24, 2015, 80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent form were randomly allocated into two groups: a control group (n = 42) and a juice group (n = 38). They received 200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery. The variables studied were serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods. The statistical analysis was performed with SPSS 20.0.
RESULTS


There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
CONCLUSIONS


Preoperative fasting abbreviation with liquid containing carbohydrate and protein before gynecologic surgeries may provide metabolic stability with lower variation in insulin resistance than inert solution.",2020,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","['80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent', 'patients undergoing gynecologic surgeries under spinal anesthesia']",['200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery'],"['serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods', 'Preoperative fasting abbreviation', 'HOMA-IR index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0703072,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","[{'ForeName': 'Gisele Vissoci', 'Initials': 'GV', 'LastName': 'Marquini', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil. Electronic address: giselemarquini@gmail.com.'}, {'ForeName': 'Francisco Edes', 'Initials': 'FE', 'LastName': 'da Silva Pinheiro', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Urbano', 'Initials': 'AU', 'LastName': 'da Costa Vieira', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Rogério Melo', 'Initials': 'RM', 'LastName': 'da Costa Pinto', 'Affiliation': 'Faculty of Maths, Nucleus of Statistical and Biometrical Studies, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Baumgarten', 'Initials': 'MGB', 'LastName': 'Kuster Uyeda', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110790']
1967,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
1968,30845333,Assessing the Impact of a Vi-polysaccharide Conjugate Vaccine in Preventing Typhoid Infection Among Bangladeshi Children: A Protocol for a Phase IIIb Trial.,"BACKGROUND


Typhoid fever illnesses are responsible for more than 100 000 deaths worldwide each year. In Bangladesh, typhoid fever is endemic, with incidence rates between 292-395 per 100 000 people annually. While considerable effort has been made to improve access to clean water and sanitation services in the country, there is still a significant annual typhoid burden, which particularly affects children. A typhoid conjugate vaccine (Vi-TCV) was recently prequalified by the World Health Organization and recommended for use, and offers the potential to greatly reduce the typhoid burden in Bangladesh.
METHODS


This study is a double-blind, cluster-randomized, controlled trial of Vi-TCV in a geographically defined area in Dhaka, Bangladesh. At least 32 500 children from 9 months to <16 years of age will be vaccinated and followed for 2 years to assess the effectiveness and safety of Vi-TCV in a real-world setting. All cluster residents will also be followed to measure the indirect effect of Vi-TCV in this community.
ETHICS AND DISSEMINATION


This protocol has been approved by the International Centre for Diarrhoeal Disease Research, Bangladesh; a University of Oxford research review; and both ethical review committees. Informed written consent and assent will be obtained before enrollment. Vi-TCV has been shown to be safe and effective in previous, smaller-scale studies. The results of this study will be shared through a series of peer-reviewed journal articles. The findings will also be disseminated to the local government, stakeholders within the community, and the population within which the study was conducted.
CONCLUSIONS


This trial is the largest and only cluster-randomized control trial of Vi-TCV ever conducted, and will describe the effectiveness of Vi-TCV in an endemic population. The results of this trial may provide important evidence to support the introduction of TCVs in countries with a high burden of typhoid.
CLINICAL TRIALS REGISTRATION


ISRCTN11643110.",2019,"The findings will also be disseminated to the local government, stakeholders within the community, and the population within which the study was conducted.
","['geographically defined area in Dhaka, Bangladesh', 'Bangladeshi Children', 'endemic population', '292-395 per 100 000 people annually']","['Vi-TCV', 'Vi-polysaccharide Conjugate Vaccine', 'typhoid conjugate vaccine (Vi-TCV']","['effectiveness and safety of Vi-TCV', 'Typhoid Infection']","[{'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.570127,"The findings will also be disseminated to the local government, stakeholders within the community, and the population within which the study was conducted.
","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Theiss-Nyland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Khanam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Arifuzzaman', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Nazmul', 'Initials': 'N', 'LastName': 'Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ashher', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}, {'ForeName': 'Yama G', 'Initials': 'YG', 'LastName': 'Farooq', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrhoeal Disease Research-Bangladesh, Dhaka.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1107']
1969,30337060,"Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial.","BACKGROUND


The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.
OBJECTIVE


To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).
DESIGN, SETTING, AND PARTICIPANTS


Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).
INTERVENTION


Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.
RESULTS AND LIMITATIONS


In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.
CONCLUSIONS


Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).
PATIENT SUMMARY


In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range.",2019,"Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12).","['Bladder Cancer Patients', '401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended', 'bladder cancer (BCa) patients', 'Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0', 'bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection']","['Radical Cystectomy', 'Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND']","['median number of dissected nodes', 'RFS', 'Clavien grade ≥3 lymphoceles', 'cancer-specific survival (CSS), overall survival (OS), and complications', 'rate of tumor recurrence']","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0229815', 'cui_str': 'Structure of external iliac lymph node'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0024248', 'cui_str': 'Lymphatic Cyst'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",401.0,0.430029,"Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12).","[{'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany. Electronic address: juergen.gschwend@tum.de.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lehmann', 'Affiliation': 'AUO Study Group, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Rübben', 'Affiliation': 'Department of Urology, University of Essen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'Wolff', 'Affiliation': 'Department of Urology, Paracelsus Hospital Golzheim Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Frohneberg', 'Affiliation': 'Department of Urology, Hospital of Karlsruhe, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'de Geeter', 'Affiliation': 'Department of Urology, Hospital of Kassel, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Urology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kälble', 'Affiliation': 'Department of Urology, Hospital of Fulda, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schnöller', 'Affiliation': 'Department of Urology, Ulm University, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Department of Urology, Hospital Ludwigshafen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Truss', 'Affiliation': 'Department of Urology, Hospital Dortmund, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'Department of Urology, Helios Hospital, Wuppertal, Germany.'}, {'ForeName': 'Uwe-Bernd', 'Initials': 'UB', 'LastName': 'Liehr', 'Affiliation': 'Department of Urology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Leißner', 'Affiliation': 'Department of Urology, Hospital Holweide, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bregenzer', 'Affiliation': 'AUO Study Group, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}]",European urology,['10.1016/j.eururo.2018.09.047']
1970,32438316,Using simulation to teach undergraduate nursing and midwifery students research design.,"Whilst it is widely accepted that the ability to critique, interpret and integrate research is an integral part of the evidence-based practice of nursing and midwifery, teaching such skills to undergraduate students is equally recognised as challenging. From a student's perspective the theoretical aspects, concepts and language of research design may seem far removed from the imperative of developing skills and gaining clinical experience. Simulation has been widely demonstrated as an effective pedagogical approach to engage students in learning and developing practical skills. The 'hands-on' approach provides a cognitive link between theory and practice that is immediately relevant to the student. Simulation training has also been used in other areas of healthcare such as communication and ethics. However, the use of simulation to demonstrate the theoretical and practical aspects of research design to midwifery and nursing students has not been explored. This paper describes a novel approach to teaching undergraduate students fundamental concepts of randomised controlled trial design through their participation in a simulated research trial. Students experienced aspects such as consent, randomisation, intervention, data collection, analysis and interpretation. Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",2020,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",[],['Simulation training'],[],[],"[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],,0.0187677,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.","[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: nigel.lee@uq.edu.au.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: a.peacock2@uq.edu.au.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102804']
1971,31801605,Effectiveness of message-framing intervention on complementary feeding related behaviors among mothers with infants aged 4-8 months: a 3-arm randomized controlled trial.,"OBJECTIVE


Complementary feeding from the age of 6 months along with breastfeeding is essential for the health of infants. The effect of educational interventions on preventing the early or late onset of complementary feeding and correcting other relevant behaviors depends on the framing of educational messages. This study aimed to compare different types of message framing on maternal behaviors in complementary feeding of infants.
MATERIALS AND METHODS


This randomized controlled trial was performed on 96 mothers in three groups of 32 subjects with four-month-old infants in Isfahan (central Iran) during May-September 2018. Data were collected through self-report using a valid researcher-made questionnaire including demographic factors, knowledge, attitude, self-efficacy, and the complementary feeding related behaviors of mothers. For 4 months, the mothers received gain-framed messages in the GF group and loss-framed messages in the LF group from two different channels. The control group only received routine education. Data analysis was performed in SPSS20 using paired t-test, ANOVA, and Chi-square at the significance level of below 0.05.
RESULTS


In this study, all three groups were matched in terms of demographic characteristics and mean scores of attitude, knowledge, and self-efficacy regarding the complementary feeding of their infants. Following the intervention, the mean knowledge score increased in all three groups and was more favorable in the intervention groups compared to the control group. However, no difference was observed between the GF and LF groups regarding their knowledge. In addition, the GF and LF groups were similar in terms of self-efficacy and behavior of mothers concerning the appropriate onset of complementary feeding. Meanwhile, the mean scores of attitude and behavior of mothers regarding the timely onset, diversity, and appropriateness of continuing complementary feeding were higher in the LF group compared with the GF group.
CONCLUSION


Framing messages changes the attitude and knowledge and improves behaviors related to complementary feeding. The interesting point is the different impacts of different types of framing on psychological and behavioral variables. In general, loss-framed messages have more effects on the attitude and certain parts of maternal behaviors.
TRIAL REGISTRATION


IRCT, IRCT20180901040919N1. Registered 29 October 2018, https://en.irct.ir/trial/33782.",2019,"Following the intervention, the mean knowledge score increased in all three groups and was more favorable in the intervention groups compared to the control group.","['96 mothers in three groups of 32 subjects with four-month-old infants in Isfahan (central Iran) during May-September 2018', 'mothers with infants aged 4-8\u2009months', 'infants']","['educational interventions', 'routine education', 'message-framing intervention']","['demographic characteristics and mean scores of attitude, knowledge, and self-efficacy', 'mean scores of attitude and behavior of mothers regarding the timely onset, diversity, and appropriateness of continuing complementary feeding', 'attitude and knowledge and improves behaviors', 'mean knowledge score', 'maternal behaviors', 'self-efficacy and behavior']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024919', 'cui_str': 'Maternal Behavior'}]",96.0,0.0679848,"Following the intervention, the mean knowledge score increased in all three groups and was more favorable in the intervention groups compared to the control group.","[{'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Rafieyan-Kopaei', 'Affiliation': 'Health Education and Health Promotion. Student Research Committee, School of Heath, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Fathian-Dastgerdi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib, Avenue, Postal Code, Isfahan, 81676-36954, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Heath, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib, Avenue, Postal Code, Isfahan, 81676-36954, Iran. fe.zamani@gmail.com.'}]",Italian journal of pediatrics,['10.1186/s13052-019-0749-0']
1972,31359782,A Randomized Crossover Study to Evaluate Recipe Acceptability in Breastfeeding Mothers and Young Children in India Targeted for a Multiple Biofortified Food Crop Intervention.,"BACKGROUND


A multiple biofortified food crop trial targeting iron, zinc, and vitamin A deficiencies among young children and their breastfeeding mothers is planned in India.
OBJECTIVE


To determine the acceptability of recipes prepared with control and biofortified pearl millet, wheat, lentils, and sweet potato.
METHODS


Children (6-24 months) and their mothers were enrolled as pairs (n = 52). Weight and height/length were determined. Mothers and children were separately, individually randomized in a crossover design to control or biofortified recipes. Children's 3-day intake was measured per recipe and crop variety. For mothers, a 9-point hedonic scale evaluated color, odor, taste, and overall acceptability.
RESULTS


Children's mean (SD) length-/height-for-age  Z -score was -1.2 (1.7), with 27% < -2 (stunted). Mean weight-for-length  Z -score was -0.6 (1.2) with 9.6% < -2 (wasted). Mother's body mass index showed 17% <18.5 and 38% >25. There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100). Mother's hedonic scores for color, odor, taste, or overall acceptability did not demonstrate any notable differences ( P  ≥ .23 for overall acceptability); combined median overall acceptability score was 8.5 (Q1: 8.0, Q3: 9.0).
CONCLUSIONS


Recipes were consumed readily, were rated as highly acceptable, and did not show any differences between biofortified and control varieties.",2019,"There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100).","['Breastfeeding Mothers and Young Children in India', 'Mothers and children', 'Children (6-24 months) and their mothers were enrolled as pairs (n = 52', 'young children and their breastfeeding mothers']","['control or biofortified recipes', 'recipes prepared with control and biofortified pearl millet, wheat, lentils, and sweet potato']","['Weight and height/length', 'Mean weight-for-length  Z -score', '9-point hedonic scale evaluated color, odor, taste, and overall acceptability', 'overall acceptability); combined median overall acceptability score', ""Children's mean (SD) length-/height-for-age  Z -score"", ""Mother's hedonic scores for color, odor, taste, or overall acceptability"", ""Children's 3-day intake""]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0331550', 'cui_str': 'Millet, Pearl'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0331252', 'cui_str': 'Ipomoea batatas'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0222045'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.131924,"There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100).","[{'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Gannon', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Thakker', 'Affiliation': ""SNDT Women's University, Mumbai, Maharashtra, India.""}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Bonam', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, Andhra Pradesh, India.'}, {'ForeName': 'Jere D', 'Initials': 'JD', 'LastName': 'Haas', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Bonam', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, Andhra Pradesh, India.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Shobha A', 'Initials': 'SA', 'LastName': 'Udipi', 'Affiliation': ""SNDT Women's University, Mumbai, Maharashtra, India.""}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}]",Food and nutrition bulletin,['10.1177/0379572119855588']
1973,32105518,Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial.,"PURPOSE


Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.
PATIENTS AND METHODS


In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat.
RESULTS


Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05;  P  = .096). The resection rate was 61% and 72% ( P  = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery ( P  < .001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2  v  19.8 months;  P = . 029). The proportion of patients who suffered serious adverse events was 52% versus 41% ( P = . 096).
CONCLUSION


Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.",2020,"Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion.","['Resectable and Borderline Resectable Pancreatic Cancer', 'Between April 2013 and July 2017', '16 centers, patients with resectable or borderline resectable pancreatic cancer', '246 eligible patients were randomly assigned; 119 were assigned to']","['preoperative chemoradiotherapy', 'Preoperative Chemoradiotherapy Versus Immediate Surgery', 'Preoperative chemoradiotherapy', 'gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine']","['radical resection rate', 'overall survival by intention to treat', 'disease-free survival and locoregional failure-free interval', 'pathologic lymph nodes, perineural invasion, and venous invasion', 'resection rate', 'Survival analysis', 'R0 resection rate', 'overall survival benefit', 'survival with preoperative chemoradiotherapy', 'suffered serious adverse events', 'Median overall survival']","[{'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1317608', 'cui_str': 'Perineural spread'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",246.0,0.167361,"Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Versteijne', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Suker', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Groothuis', 'Affiliation': 'Clinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL), Nijmegen, the Netherlands.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Akkermans-Vogelaar', 'Affiliation': 'Clinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL), Nijmegen, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bert A', 'Initials': 'BA', 'LastName': 'Bonsing', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Geert-Jan M', 'Initials': 'GM', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Department of Surgery, Division of Hepato-Pancreato-Biliary & Oncology, European Surgery Center Aachen Maastricht, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Ferry A L M', 'Initials': 'FALM', 'LastName': 'Eskens', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan Willem B', 'Initials': 'JWB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala Oncology Centre, Zwolle, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Groot Koerkamp', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Marjolein Y V', 'Initials': 'MYV', 'LastName': 'Homs', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Emile D', 'Initials': 'ED', 'LastName': 'Kerver', 'Affiliation': 'Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Saskia A C', 'Initials': 'SAC', 'LastName': 'Luelmo', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Neelis', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Nuyttens', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Gabriel M R M', 'Initials': 'GMRM', 'LastName': 'Paardekooper', 'Affiliation': 'Department of Radiation Oncology, Isala Oncology Center, Zwolle, the Netherlands.'}, {'ForeName': 'Gijs A', 'Initials': 'GA', 'LastName': 'Patijn', 'Affiliation': 'Department of Surgery, Isala Oncology Center, Zwolle, the Netherlands.'}, {'ForeName': 'Maurice J C', 'Initials': 'MJC', 'LastName': 'van der Sangen', 'Affiliation': 'Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, GROW School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Wilmink', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis J', 'Initials': 'CJ', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper H', 'Initials': 'CH', 'LastName': 'van Eijck', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'van Tienhoven', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02274']
1974,31424399,An Indoor Therapeutic Garden for Behavioral Symptoms in Alzheimer's Disease: A Randomized Controlled Trial.,"BACKGROUND


Behavioral and psychological symptoms of dementia (BPSD) affect 60-90% of patients with Alzheimer's disease (AD).
OBJECTIVE


To determine if environmental therapy is an effective strategy to reduce BPSD, we tested 163 patients with AD with Neuropsychiatric Inventory (NPI) before and after 6 months of an indoor therapeutic garden (TG) or standard environment.
METHODS


A single-blind randomized controlled trial on AD patients with BPSD. Participants were randomized to an indoor TG (N = 82), or standard environment (control, N = 81) for 6 months.
PRIMARY OUTCOME


change in the NPI score from baseline (T0) to end of treatment (T1).
SECONDARY OUTCOMES


change in use of quetiapine, cognition, activities of daily living, salivary cortisol, blood pressure from T0 to T1.
RESULTS


NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001). No adverse events were reported.
CONCLUSION


The indoor TG seems safe and may reduce BPSD, medication intake, and cortisol levels in AD.",2019,"NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001).","[""patients with Alzheimer's disease (AD"", ""Alzheimer's Disease"", '163 patients with AD with Neuropsychiatric Inventory (NPI) before and after 6 months of an indoor therapeutic garden (TG) or standard environment', 'AD patients with BPSD']","['quetiapine', 'indoor TG (N\u200a=\u200a82), or standard environment (control, N\u200a=\u200a81) for 6 months']","['salivary cortisol', 'adverse events', 'NPI score from baseline (T0) to end of treatment (T1', 'BPSD, medication intake, and cortisol levels', 'quetiapine, cognition, activities of daily living, salivary cortisol, blood pressure from T0 to T1', 'blood pressure', 'NPI score', 'Mini-Mental State Examination']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1868717', 'cui_str': 'BPSD'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1868717', 'cui_str': 'BPSD'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]",,0.281332,"NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brasioli', 'Affiliation': 'Monsignor Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Sollima', 'Affiliation': 'Department of Clinical and Experimental Sciences, University Health and Wealth of Brescia, Brescia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Monsignor Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190394']
1975,32438250,Ante-and post-mortem strategies to improve the meat quality of high-value muscles harvested from farmed male common eland (Taurotragus oryx).,"The effects of immunocastration, pelvic suspension and wet ageing on the meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles of male common eland were evaluated. Ten subadult males were either immunocastrated (n = 5) or remained intact (n = 5) throughout a four-month growth trial, after which their carcass sides were randomly allocated to either pelvic- or Achilles-suspension. The LTL and BF were further aged for 14 days, measuring changes in the physical quality weekly. The sensory quality of the LTL and BF were determined after ageing (8/9 days, respectively). Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force. All muscles reached minimum shear force after seven days of ageing, and the panellists ranked the pelvic-suspended muscles higher for tenderness traits. Incorporating pelvic suspension and wet ageing into the commercial processing of eland carcasses should be considered to improve overall meat quality.",2020,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","['Ten subadult males were either immunocastrated (n\xa0=\xa05) or remained intact (n\xa0=\xa05) throughout a four-month growth trial, after which their carcass sides', 'high-value muscles harvested from farmed male common eland (Taurotragus oryx']","['pelvic- or Achilles-suspension', 'immunocastration, pelvic suspension and wet ageing']","['meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles', 'sensory quality of the LTL and BF', 'overall meat quality']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0325245', 'cui_str': 'Taurotragus oryx'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",10.0,0.0142914,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","[{'ForeName': 'Tersia', 'Initials': 'T', 'LastName': 'Needham', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic. Electronic address: needham@ftz.czu.cz.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Kotrba', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic; Department of Ethology, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic.'}, {'ForeName': 'Louwrens C', 'Initials': 'LC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Animal Sciences, University of Stellenbosch, Private Bag X1, Matieland, Stellenbosch 7602, South Africa; Centre for Nutrition and Food Sciences, Queensland Alliance for Agriculture and Food Innovation (QAAFI), The University of Queensland, Health and Food Sciences Precinct, 39 Kessels Rd, Coopers Plains 4108. Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bureš', 'Affiliation': 'Department of Cattle Breeding, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic; Department of Food Quality, Faculty of Agrobiology, Food and Natural Sciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic.'}]",Meat science,['10.1016/j.meatsci.2020.108183']
1976,32438267,Effect of exercise on knee joint contact forces in people following medial partial meniscectomy: A secondary analysis of a randomised controlled trial.,"BACKGROUND


Arthroscopic partial meniscectomy may cause knee osteoarthritis, which may be related to altered joint loading. Previous research has failed to demonstrate that exercise can reduce medial compartment knee loads following meniscectomy but has not considered muscular loading in their estimates.
RESEARCH QUESTION


What is the effect of exercise compared to no intervention on peak medial tibiofemoral joint contact force during walking using an electromyogram-driven neuromusculoskeletal model, following medial arthroscopic partial meniscectomy?
METHODS


This is a secondary analysis of a randomized controlled trial (RCT). 41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months, were randomly allocated to either a 12-week, home-based, physiotherapist-guided exercise program or to no exercise (control group). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from eight lower-limb muscles were acquired during self-selected normal- and fast-paced walking at baseline and follow-up. An electromyogram-driven neuromusculoskeletal model estimated medial compartment contact forces (body weight). Linear regression models evaluated between-group differences (mean difference (95% CI)).
RESULTS


There were no significant between-group differences in the change (follow-up minus baseline) in first peak medial contact force during self-selected normal- or fast-paced walking (0.07 (-0.08 to 0.23), P = 0.34 and 0.01 (-0.19 to 0.22), P = 0.89 respectively). No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02 (-0.17 to 0.22), P = 0.81 respectively). At the individual level, variability was observed for changes in first (range -26.2% to +31.7%) and second (range -46.5% to +59.9%) peak tibiofemoral contact force.
SIGNIFICANCE


This is the first study to apply electromyogram-driven neuromusculoskeletal modelling to an exercise intervention in a RCT. While our results suggest that a 12-week exercise program does not alter peak medial knee loads after meniscectomy, within-participant variability suggests individual-specific muscle activation patterns that warrant further investigation.",2020,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","['41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months', 'people following medial partial meniscectomy']","['exercise intervention', 'physiotherapist-guided exercise program or to no exercise (control group', 'exercise']","['knee joint contact forces', 'peak medial knee loads', 'change in second peak medial contact force during normal- or fast-paced walking', 'peak tibiofemoral contact force', 'peak medial contact force during self-selected normal- or fast-paced walking']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",41.0,0.0930649,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Starkey', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin K', 'Initials': 'GK', 'LastName': 'Lenton', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Saxby', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia. Electronic address: halm@unimelb.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.025']
1977,32438300,Efficacy of 4 wk of home enteral feeding supplementation after esophagectomy on immune function: A randomized controlled trial.,"OBJECTIVES


In recent years, home enteral nutrition (HEN) has been adopted as a feasible and safe form of nutrition for patients undergoing esophagectomy. The aim of this study was to compare the effects of 4 wk of HEN with standard enteral nutrition (SEN) on immune function, nutritional status, and survival in patients undergoing esophagectomy.
METHODS


A parallel-group, randomized, single-blind, clinical trial was conducted between April 1 and August 1, 2017. Eighty patients were enrolled in the study and 62 were eligible for analysis. An enteral feeding pump was used to infuse enteral nutrition via jejunostomy tube postoperatively. Patients in HEN group were instructed to independently administer jejunostomy feeds at home. Immune parameters and nutritional indicators were measured at preoperative day 7 and at postoperative day 30.
RESULTS


There were no significant differences in baseline characteristics between the two groups. The levels of immunoglobulin (Ig)A and IgG, which can reflect a patient's immune function, significantly increased in the HEN group compared with those in the SEN group (P = 0.042 and P = 0.003, respectively). Comparing the two groups, 2-y progression-free survival and overall survival had no significant differences in survival curves (P = 0.36 and P = 0.29, respectively).
CONCLUSION


Four weeks of HEN is a safe and feasible nutritional strategy to improve immune function and nutritional status after esophagectomy. Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.",2020,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","['Eighty patients were enrolled in the study and 62 were eligible for analysis', 'patients undergoing esophagectomy']","['home enteral nutrition (HEN', 'SEN', 'HEN', 'home enteral feeding supplementation', 'HEN with standard enteral nutrition (SEN']","['2-y progression-free survival and overall survival', 'levels of immunoglobulin (Ig)A and IgG', 'survival curves', 'immune function and nutritional status', 'survival', 'immune function, nutritional status, and survival', 'Immune parameters and nutritional indicators', 'immune function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",80.0,0.113342,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","[{'ForeName': 'Xiao-Kun', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhuang-Zhuang', 'Initials': 'ZZ', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Sai-Guang', 'Initials': 'SG', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kai-Chao', 'Initials': 'KC', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China; Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China. Electronic address: dryishen@nju.edu.cn.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110787']
1978,31422924,Prognostic performance of the Society of Thoracic Surgeons risk score in patients with left main coronary artery disease undergoing revascularisation: a post hoc analysis of the EXCEL trial.,"AIMS


Accurate risk prediction in patients undergoing revascularisation is essential. We aimed to assess the predictive performance of Society of Thoracic Surgeons (STS) risk models in patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES).
METHODS AND RESULTS


The predictive performance of STS risk models for perioperative mortality, stroke and renal failure was evaluated for their discriminative ability (C statistic) and calibration (Hosmer-Lemeshow goodness-of-fit-test; χ2 and p-values) among patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923) from the randomised EXCEL trial. STS risk scores, in CABG patients, showed good discrimination for 30-day mortality and average discrimination for stroke (C statistic 0.730 and 0.629, respectively) with average calibration. For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke. The predictive performance for renal failure was good for CABG (C statistic 0.82), yet poor for PCI (C statistic 0.59).
CONCLUSIONS


In selected patients with LMCAD from the EXCEL trial, STS risk models showed good predictive performance for CABG yet lacked predictive performance for PCI for perioperative mortality and renal failure. The STS stroke risk model was surprisingly more discriminating in PCI compared to CABG. Improved and procedure-specific risk prediction instruments are needed to accurately estimate adverse events after LMCAD revascularisation by CABG and PCI. ClinicalTrials.gov Identifier: NCT01205776.",2020,"For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke.","['Patients with Left Main Coronary Artery Disease Undergoing Revascularization in the EXCEL trial', 'patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES', 'patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923', 'patients undergoing revascularization is essential']",[],"['STS risk scores', 'predictive performance for renal failure', '30-day mortality and average discrimination for stroke', 'perioperative mortality, stroke and renal failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.06067,"For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke.","[{'ForeName': 'Daniel J F M', 'Initials': 'DJFM', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ''}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': ''}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00417']
1979,31424391,Self and Informant Memory Reports in FINGER: Associations with Two-Year Cognitive Change.,"BACKGROUND


Subjective memory complaints (SMCs) may be the first sign of cognitive decline in aging.
OBJECTIVE


To examine whether SMCs reported by oneself and informant predict cognitive change over 2 years among at-risk elderly people, and to determine the relationship of different types of SMCs (prospective and retrospective memory complaints) and change in cognitive function.
METHODS


This investigation is part of the FINGER project, which is a multicenter randomized controlled trial aiming at preventing cognitive decline in cognitively healthy older adults with increased risk of dementia. A subsample of 303 control-group participants (aged 60-80 years) and their informants (n = 261) rated the frequency of SMCs, using the Prospective and Retrospective Memory Questionnaire (PRMQ). Cognitive performance was measured at baseline and at 1- and 2-year follow-up visits using a neuropsychological test battery.
RESULTS


Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses. Self-reported retrospective memory problems predicted less improvement in all cognitive domains, whereas prospective memory problems did not. Informant-reported memory problems were not linked to subsequent change in cognition.
CONCLUSION


Our results indicate that self-reported SMCs, measured with PRMQ, predict future cognitive change in several cognitive domains. By contrast, reports by informants were not linked to changes in cognition. Among cognitively healthy at-risk elderly individuals, the persons themselves observe more easily problems relevant for their future cognitive trajectories than their informants.",2019,"RESULTS


Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses.","['cognitively healthy older adults with increased risk of dementia', 'cognitively healthy at-risk elderly individuals', 'A subsample of 303 control-group participants (aged 60-80 years) and their informants (n\u200a=\u200a261) rated the frequency of SMCs, using the Prospective and Retrospective Memory Questionnaire (PRMQ', 'FINGER']",['SMCs'],"['global cognition, executive function, and memory', 'Cognitive performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0218107,"RESULTS


Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vaskivuo', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hokkanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Hänninen', 'Affiliation': 'Neurocenter/ Neurology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'University of Oulu, Center for Life Course Health Research, Oulu, Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bäckman', 'Affiliation': 'Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden and Department of Social and Psychological Sciences, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'University of Oulu, Center for Life Course Health Research, Oulu, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Neurocenter/ Neurology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190133']
1980,31424410,A Pilot Double-Blind Randomized Controlled Trial of Cognitive Training Combined with Transcranial Direct Current Stimulation for Amnestic Mild Cognitive Impairment.,"BACKGROUND


There is currently no effective intervention for improving memory in people at increased risk for dementia. Cognitive training (CT) has been promising, though effects are modest, particularly at follow-up.
OBJECTIVE


To investigate whether adjunctive non-invasive brain stimulation (transcranial direct current stimulation, tDCS) could enhance the memory benefits of CT in amnestic mild cognitive impairment (aMCI).
METHODS


Participants with aMCI were randomized to receive CT with either Active tDCS (2 mA for 30 min and 0.016 mA for 30 min) or Sham tDCS (0.016 mA for 60 min) for 15 sessions over a period of 5 weeks in a double-blind, sham-controlled, parallel group clinical trial. The primary outcome measure was the California Verbal Learning Task 2nd Edition.
RESULTS


68 participants commenced the intervention. Intention-to-treat (ITT) analysis showed that the CT+Active tDCS group significantly improved at post treatment (p = 0.033), and the CT+Sham tDCS group did not (p = 0.050), but there was no difference between groups. At the 3-month follow-up, both groups showed large-sized memory improvements compared to pre-treatment (CT+Active tDCS: p < 0.01, d = 0.99; CT+Sham tDCS: p < 0.01, d = 0.74), although there was no significant difference between groups.
CONCLUSION


This study found that CT+Active tDCS did not produce greater memory improvement compared to CT+Sham tDCS. Large-sized memory improvements occurred in both conditions at follow-up. One possible interpretation, based on recent novel findings, is that low intensity tDCS (used as 'sham') may have contributed biological effects. Further work should use a completely inert tDCS sham condition.",2019,"At the 3-month follow-up, both groups showed large-sized memory improvements compared to pre-treatment (CT+Active tDCS: p < 0.01, d = 0.99; CT+Sham tDCS: p < 0.01, d = 0.74), although there was no significant difference between groups.
","['amnestic mild cognitive impairment (aMCI', '68 participants commenced the intervention', 'Participants with aMCI', 'Amnestic Mild Cognitive Impairment']","['adjunctive non-invasive brain stimulation (transcranial direct current stimulation, tDCS', 'Cognitive Training Combined with Transcranial Direct Current Stimulation', 'CT with either Active tDCS (2\u200amA for 30\u200amin and 0.016\u200amA for 30\u200amin) or Sham tDCS', 'CT+Sham tDCS', 'CT+Active tDCS', 'Cognitive training (CT']","['large-sized memory improvements', 'California Verbal Learning Task 2nd Edition', 'Intention-to-treat (ITT) analysis']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",68.0,0.327367,"At the 3-month follow-up, both groups showed large-sized memory improvements compared to pre-treatment (CT+Active tDCS: p < 0.01, d = 0.99; CT+Sham tDCS: p < 0.01, d = 0.74), although there was no significant difference between groups.
","[{'ForeName': 'Donel M', 'Initials': 'DM', 'LastName': 'Martin', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Adith', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gates', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Oyetunde', 'Initials': 'O', 'LastName': 'Gbadeyan', 'Affiliation': 'University of Queensland Centre for Clinical Research, Brisbane, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'University of Queensland Centre for Clinical Research, Brisbane, Australia.'}, {'ForeName': 'Perminder', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Loo', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190306']
1981,31286387,Long-term effectiveness and cost-effectiveness of an 18-week supervised exercise program in patients treated with autologous stem cell transplantation: results from the EXIST study.,"PURPOSE


To evaluate the long-term effectiveness and cost-effectiveness of a supervised 18-week high-intensity exercise program compared with usual care in patients treated with autologous stem cell transplantation.
METHODS


One hundred nine patients were randomly assigned to the exercise intervention (n = 54) or the usual care control group (n = 55). Data on cardiorespiratory fitness (VO 2 peak), handgrip strength, general fatigue, and health-related quality of life (quality-adjusted life years [QALYs]) were collected at baseline (T0), after completion of the exercise intervention or at a similar time point in the control group (T1) and 12 months later (T2). Cost questionnaires were used to assess societal costs. Long-term effectiveness (at T2) was evaluated using linear mixed model analyses. For the economic evaluation, missing data were imputed using multiple imputation, and data were analyzed using linear mixed models.
RESULTS


At T2, no statistically significant differences were found between the intervention and control group for VO 2 peak (0.12; 95%CI - 1.89; 2.14 ml/min/kg), handgrip strength (- 1.08; 95%CI- 2.47; 2.31), and general fatigue (- 0.69; 95%CI - 2.52; 1.14). During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452). Intervention costs were €1340 per patient. For all outcomes, the probability of the intervention being cost-effective was low at reasonable values of willingness-to-pay.
CONCLUSION


We found no evidence for the exercise intervention being effective on physical fitness and fatigue, nor cost-effective from a societal perspective.
TRIAL REGISTRATION


The study was prospectively registered on 27 May 2010 at the Netherlands Trial Register ( NTR2341 ).
IMPLICATIONS FOR CANCER SURVIVORS


The current exercise intervention should not be recommended to patients recently treated with autologous stem cell transplantation.",2019,"During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452).","['FOR CANCER SURVIVORS', '27 May 2010 at the Netherlands Trial Register ( NTR2341 ', 'patients treated with autologous stem cell transplantation', 'One hundred nine patients']","['supervised 18-week high-intensity exercise program', 'current exercise intervention', 'exercise intervention', 'autologous stem cell transplantation', '18-week supervised exercise program', 'usual care control group']","['cardiorespiratory fitness (VO 2 peak), handgrip strength, general fatigue, and health-related quality of life (quality-adjusted life years [QALYs', 'probability of the intervention being cost-effective', 'QALYs and societal costs', 'general fatigue', 'handgrip strength', 'Intervention costs', 'societal costs', 'physical fitness and fatigue, nor cost-effective']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",109.0,0.0862264,"During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452).","[{'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Persoon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Jongeneel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, De Boelelaan 1089a, 1018HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marie José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Haematology, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brug', 'Affiliation': 'National Institute for Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Mai J M', 'Initials': 'MJM', 'LastName': 'Chinapaw', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laurien M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, De Boelelaan 1089a, 1018HV, Amsterdam, The Netherlands. l.buffart@vumc.nl.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00775-9']
1982,31416692,"Safety and immunogenicity of the chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.","BACKGROUND


Chlamydia is the most common sexually transmitted bacterial infection worldwide. National screening programmes and antibiotic treatment have failed to decrease incidence, and to date no vaccines against genital chlamydia have been tested in clinical trials. We aimed to assess the safety and immunogenicity, in humans, of a novel chlamydia vaccine based on a recombinant protein subunit (CTH522) in a prime-boost immunisation schedule.
METHODS


This phase 1, first-in-human, double-blind, parallel, randomised, placebo-controlled trial was done at Hammersmith Hospital in London, UK, in healthy women aged 19-45 years. Participants were randomly assigned (3:3:1) to three groups: CTH522 adjuvanted with CAF01 liposomes (CTH522:CAF01), CTH522 adjuvanted with aluminium hydroxide (CTH522:AH), or placebo (saline). Participants received three intramuscular injections of 85 μg vaccine (with adjuvant) or placebo to the deltoid region of the arm at 0, 1, and 4 months, followed by two intranasal administrations of 30 μg unadjuvanted vaccine or placebo (one in each nostril) at months 4·5 and 5·0. The primary outcome was safety and the secondary outcome was humoral immunogenicity (anti-CTH522 IgG seroconversion). This study is registered with Clinicaltrials.gov, number NCT02787109.
FINDINGS


Between Aug 15, 2016, and Feb 13, 2017, 35 women were randomly assigned (15 to CTH522:CAF01, 15 to CTH522:AH, and five to placebo). 32 (91%) received all five vaccinations and all participants were included in the intention-to-treat analyses. No related serious adverse reactions were reported, and the most frequent adverse events were mild local injection-site reactions, which were reported in all (15 [100%] of 15) participants in the two vaccine groups and in three (60%) of five participants in the placebo group (p=0·0526 for both comparisons). Intranasal vaccination was not associated with a higher frequency of related local reactions (reported in seven [47%] of 15 participants in the active treatment groups vs three [60%] of five in the placebo group; p=1·000). Both CTH522:CAF01 and CTH522:AH induced anti-CTH522 IgG seroconversion in 15 (100%) of 15 participants after five immunisations, whereas no participants in the placebo group seroconverted. CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH.
INTERPRETATION


CTH522 adjuvanted with either CAF01 or aluminium hydroxide appears to be safe and well tolerated. Both vaccines were immunogenic, although CTH522:CAF01 had a better immunogenicity profile, holding promise for further clinical development.
FUNDING


European Commission and The Innovation Fund Denmark.",2019,"CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH.
","['Between Aug 15, 2016, and Feb 13, 2017', '35 women', 'healthy women aged 19-45 years']","['CTH522 adjuvanted with CAF01 liposomes (CTH522:CAF01), CTH522 adjuvanted with aluminium hydroxide (CTH522:AH), or placebo (saline', 'CTH522:CAF01, 15 to CTH522:AH, and five to placebo', 'placebo', 'chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide', 'recombinant protein subunit (CTH522', 'CTH522:CAF01', 'intramuscular injections of 85 μg vaccine (with adjuvant) or placebo', 'vaccine or placebo', 'CAF01 or aluminium hydroxide']","['accelerated seroconversion, increased IgG titres', 'higher frequency of related local reactions', 'safe and well tolerated', 'safety and immunogenicity', 'humoral immunogenicity (anti-CTH522 IgG seroconversion', 'serious adverse reactions', 'anti-CTH522 IgG seroconversion']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",35.0,0.702909,"CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH.
","[{'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Helene B', 'Initials': 'HB', 'LastName': 'Juel', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bang', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Cheeseman', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Dohn', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Max P', 'Initials': 'MP', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Korsholm', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anja W', 'Initials': 'AW', 'LastName': 'Olsen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'McFarlane', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Moen', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Ruhwald', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark. Electronic address: pa@ssi.dk.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Shattock', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Follmann', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30279-8']
1983,32268801,"The Coronary ARteriogenesis with combined Heparin and EXercise therapy in chronic refractory Angina (CARHEXA) trial: A double-blind, randomized, placebo-controlled stress echocardiographic study.","BACKGROUND


Coronary collateral circulation exerts protective effects on myocardial ischaemia due to coronary artery disease and can be promoted by exercise with heparin co-administration. Whether this arteriogenetic effect is accompanied by functional improvement of left ventricle during stress and lessening of angina symptoms remains unknown.
AIMS


To evaluate the anti-ischaemic efficacy of heparin plus exercise in coronary artery disease.
METHODS


In a prospective, single-centre, randomized, double-blind study we recruited 32 'no-option' patients (27 males; mean age 61 ± 8 years) with stable angina, exercise-induced ischaemia and coronary artery disease not suitable for revascularization. All underwent a two-week cycle of exercise (two exercise sessions per day, five days per week) and were randomized ( n  = 16 per group) to intravenous placebo (0.9% saline) versus unfractionated heparin (5.000 IU intravenously), 10 min prior to exercise. We assessed Canadian Cardiovascular Society angina class, stress electrocardiogram and echo parameters (wall motion score index) and computed tomography angiography for collaterals.
RESULTS


After two-week cycle, Canadian Cardiovascular Society class statistically decreased in both groups (heparin plus exercise group: 2.6 ± 0.7 to 1.9 ± 0.7,  p  < 0.001, exercise group: 2.4 ± 0.7 to 2.1 ± 0.9,  p  = 0.046). Only the heparin plus exercise group improved time-to-ST segment depression (before 270, 228-327 s  vs . after 339, 280-360 s,  p  = 0.012) and wall motion score index (before 1.38 ± 0.25  vs . after 1.28 ± 0.18,  p  = 0.005). By multi-slice computed tomography angiography, collaterals improved in 12/15 (80%) in the heparin plus exercise group versus 2/16 (12.5%) in the exercise group ( p  < 0.001).
CONCLUSION


A two-week, 10-test cycle of heparin plus exercise is better than exercise in improving angina class, myocardial ischaemia and collaterals by computed tomography angiography.",2020,,[],"['placebo', 'Heparin and EXercise therapy']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.503596,,"[{'ForeName': 'Marija T', 'Initials': 'MT', 'LastName': 'Petrovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Djordjevic-Dikic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vojislav', 'Initials': 'V', 'LastName': 'Giga', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Boskovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vladan', 'Initials': 'V', 'LastName': 'Vukcevic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Cvetic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mladenovic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Radmili', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Markovic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Dobric', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Aleksandric', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Milorad', 'Initials': 'M', 'LastName': 'Tesic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Juricic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Nedeljkovic Beleslin', 'Affiliation': 'Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Stojkovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Miodrag C', 'Initials': 'MC', 'LastName': 'Ostojic', 'Affiliation': 'Institute for Cardiovascular Diseases Dedinje, Serbia.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Beleslin', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Picano', 'Affiliation': 'Institute of Clinical Physiology, CNR - Consiglio Nazionale Ricerche, Italy.'}]",European journal of preventive cardiology,['10.1177/2047487320915661']
1984,31809403,Noninvasive Hemodynamic Monitoring of Cocaine-Induced Changes in Cardiac Output and Systemic Vascular Resistance in Subjects With Chronic Cocaine Use Disorder.,"BACKGROUND


Cocaine use disorder (CUD) is a common problem in the United States and worldwide. The mechanisms by which cocaine induces acute cardiovascular toxicity are various. When systemically absorbed through inhaled or intravenous routes, cocaine induces an acute rise in the heart rate (HR) and blood pressure (BP) leading to a significant increase in the cardiac output (CO) and myocardial oxygen demand. Subjects with chronic CUD represent a special population that has experienced long-term cocaine exposure, often without showing signs of cardiovascular disease. We herein present prospectively collected data on the acute hemodynamic effects of intravenous cocaine in a cohort of nontreatment-seeking individuals with CUD without cardiovascular disease.
METHODS AND RESULTS


Baseline physiologic data were collected while participants underwent infusion of escalating doses of cocaine (10, 20, and 40 mg administered over 2 minutes) at baseline and after receiving single-blind placebo treatment. Continuous noninvasive hemodynamic monitoring was performed throughout the infusion sessions using the ccNexfin finger cuffs (Edwards Lifesciences Corp, Irvine, CA). The recorded arterial BP tracings allowed for the measurement of beat-to-beat changes in HR, BP, stroke volume, CO, and systemic vascular resistance (SVR). None of the subjects experienced a treatment-related serious adverse event. Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
CONCLUSIONS


Intravenous cocaine in a cohort of otherwise healthy subjects with CUD produced dose-dependent increases in CO, largely explained by an increase in HR, accompanied by a dose-dependent decrease in SVR.",2019,"Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
","['Subjects with chronic CUD', 'Subjects With Chronic Cocaine Use Disorder', 'cohort of nontreatment-seeking individuals with CUD without cardiovascular disease']","['placebo', 'Cocaine', 'cocaine']","['SVR', 'heart rate (HR) and blood pressure (BP', 'HR, BP, stroke volume, CO, and systemic vascular resistance (SVR', 'cardiac output (CO) and myocardial oxygen demand', 'median SVR', 'Cardiac Output and Systemic Vascular Resistance', 'recorded arterial BP tracings', 'acute cardiovascular toxicity', 'median HR, BP, CO, and +dP/dt (a measure of cardiac contractility']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0741744,"Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Westman', 'Affiliation': 'Pauley Heart Center, School of Medicine, Richmond, VA.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Trankle', 'Affiliation': 'Pauley Heart Center, School of Medicine, Richmond, VA.'}, {'ForeName': 'Sade', 'Initials': 'S', 'LastName': 'Johns', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Institute of Drug and Alcohol Studies.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Buckley', 'Affiliation': 'Department of Pharmacotherapy, School of Pharmacy, Richmond, VA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Institute of Drug and Alcohol Studies.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Frederick Gerard', 'Initials': 'FG', 'LastName': 'Moeller', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000740']
1985,31409915,Add-on ezetimibe treatment to low-dose statins vs medium-intensity statin monotherapy in coronary artery disease patients with poorly controlled dyslipidemia.,"Although ezetimibe has potential value as an add-on therapy to statins, it is not established whether the addition of ezetimibe to statin therapy is more effective than double-dose statin monotherapy. We conducted a crossover design study. Twenty-one coronary artery disease (CAD) patients whose lipid profiles had not achieved Japanese guideline recommendations (JAS 2017), despite receiving low-dose statin therapy, were divided into two groups. Group A received ezetimibe 10 mg in addition to the baseline dose of statin for the first 3 months and was then switched to monotherapy with a double dose of statin for the next 3 months. Group B first received a double dose of statin for 3 months and was then switched to ezetimibe 10 mg in addition to a baseline dose of statin for the next 3 months. Compared with the baseline, double-dose statin therapy reduced low-density lipoprotein (LDL)-cholesterol (from 118 ± 22 to 104 ± 15 mg/dL, P < 0.05) and malondialdehyde-modified LDL (MDA-LDL) (from 142 ± 35 to 126 ± 24 U/L, P < 0.05) but did not lower high-sensitivity C-reactive protein (hsCRP) (3.02 ± 0.47 and 2.98 ± 0.41 log [ng/ml]). The addition of ezetimibe to a baseline dose of statin further reduced LDL-cholesterol (to 89 ± 15, P < 0.0001) and MDA-LDL (to 114 ± 22 U/L, P < 0.001) and reduced hsCRP (to 2.78 ± 0.38 log (ng/ml), P < 0.05). The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe. Add-on ezetimibe treatment appears superior to double-dose statin therapy in CAD patients with poorly controlled dyslipidemia in terms of reductions in LDL-cholesterol level, lipid peroxidation, and inflammation.",2019,"The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe.","['Twenty-one coronary artery disease (CAD) patients whose lipid profiles had not achieved Japanese guideline recommendations (JAS 2017), despite receiving low-dose statin therapy', 'coronary artery disease patients with poorly controlled dyslipidemia', 'CAD patients with poorly controlled dyslipidemia']","['ezetimibe 10\u2009mg in addition to the baseline dose of statin', 'ezetimibe', 'statins vs medium-intensity statin monotherapy', 'ezetimibe 10\u2009mg in addition to a baseline dose of statin']","['reduced hsCRP', 'levels of MDA-LDL', 'malondialdehyde-modified LDL (MDA-LDL', 'high-sensitivity C-reactive protein (hsCRP', 'low-density lipoprotein (LDL)-cholesterol', 'LDL-cholesterol', 'hsCRP', 'MDA-LDL', 'LDL-cholesterol level, lipid peroxidation, and inflammation', 'LDL-cholesterol level']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}]","[{'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",21.0,0.154215,"The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan. masakuma@dokkyomed.ac.jp.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Ryouta', 'Initials': 'R', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yazawa', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Masuyama', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hirose', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Waku', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hasumi', 'Affiliation': 'Department of Internal Medicine, Nishiyamado-Keiwa Hospital, 3247-1 Kounosu, Naka, Ibaraki, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Numao', 'Affiliation': 'Department of Internal Medicine, Mori Hospital, 674 Imaichi, Nikkou, Tochigi, Japan.'}, {'ForeName': 'Shichiro', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0308-5']
1986,32246478,Results of the prematurely terminated TEMPLE randomized controlled trial in patients with myelodysplastic syndrome: liberal versus restrictive red blood cell transfusion threshold.,,2020,,['patients with myelodysplastic syndrome'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]",[],[],,0.0599636,,"[{'ForeName': 'A J G', 'Initials': 'AJG', 'LastName': 'Jansen', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'van den Bosch', 'Affiliation': 'Department of Oncology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Peter A W', 'Initials': 'PAW', 'LastName': 'Te Boekhorst', 'Affiliation': 'Department of Hematology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Schipperus', 'Affiliation': 'Department of Hematology, Leyenburg Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Erik A M', 'Initials': 'EAM', 'LastName': 'Beckers', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}]",Transfusion,['10.1111/trf.15708']
1987,31126208,Temperature-sensitive anti-adhesive poloxamer hydrogel decreases fascial adhesion in total knee arthroplasty: A prospective randomized controlled study.,,2019,"There were no significant differences in postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction.","['Sixty patients who underwent unilateral primary total knee arthroplasty for knee osteoarthritis', 'after total knee arthroplasty', 'total knee arthroplasty']","['TAP hydrogel', 'Temperature-sensitive anti-adhesive poloxamer hydrogel', 'TAP group or control group', 'TAP hydrogel group, while normal saline']","['fascial adhesion and clinical outcomes including range of motion, pain, and patient satisfaction', 'surgical site complication', 'degree of skin fold, fascial thickness measured with ultra-sonography, postoperative pain visual analogue scale, total cumulative analgesics consumption, clinical scores, and degree of satisfaction', 'degree of suprapatellar skin folding', 'efficacy and safety', 'postoperative fascial adhesion', 'range of motion', 'postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0086827', 'cui_str': 'Poloxamers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",60.0,0.0178106,"There were no significant differences in postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction.","[{'ForeName': 'Jong-Keun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': '1 Hanil General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do Weon', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Du Hyun', 'Initials': 'DH', 'LastName': 'Ro', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}]",Journal of biomaterials applications,['10.1177/0885328219852890']
1988,31414166,"Do Ice Packs Reduce Postoperative Midline Incision Pain, NSAID or Narcotic Use?","BACKGROUND


Adequate postoperative analgesia, especially after major abdominal surgery is important for recovery, early mobility, and patient satisfaction. We aimed to study the effects of cryotherapy via an ice pack in the immediate postoperative period, for patients undergoing major abdominal operations.
METHODS


This prospective study was conducted at our tertiary care referral center in a low-middle-income country setting. The preoperative patient characteristics, intra-operative variables, and postoperative outcomes were compared between two sets of patients. Cryotherapy was delivered via frozen gel packs for 24 h immediately following laparotomy. Pain relief was assessed with visual analog pain scores (VAS). Comparisons between groups were measured by Chi-square test, Fischer's exact test, or Mann-Whitney U test as appropriate.
RESULTS


Sixty-eight patients were included in the study: 33 in the cryotherapy group and 35 in the non-cryotherapy group. Mean postoperative pain scores (VAS) were significantly lower in the cryotherapy group versus the control group (3.97 ± 0.6 vs. 4.9 ± 0.7 on postoperative day (POD) 1; p <  0.001, and 3 ± 0.5 vs. 09 ± 0.8 on POD2; p < 0.001). The median narcotic use in morphine equivalents was lesser in the cryotherapy group from POD 1-3 (66 (IQR-16) vs. 89 (IQR-17); p = 0.001). No significant difference was seen in the NSAID use between the groups. The cryotherapy group was also found to have a lesser incidence of surgical site infection (p = 0.03) and better lung function based on incentive spirometry (p = 0.01) and demonstrated earlier functional recovery based on their ability to perform the sit-to-stand test (p = 0.001).
CONCLUSION


Ice packs are a simple, cost-effective adjuvant to standard postoperative pain management which reduce pain and narcotic use and promote early rehabilitation.",2019,"The cryotherapy group was also found to have a lesser incidence of surgical site infection (p = 0.03) and better lung function based on incentive spirometry (p = 0.01) and demonstrated earlier functional recovery based on their ability to perform the sit-to-stand test (p = 0.001).
","['tertiary care referral center in a low-middle-income country setting', 'patients undergoing major abdominal operations', 'Sixty-eight patients were included in the study: 33 in the cryotherapy group and 35 in the non-cryotherapy group']","['cryotherapy', 'Cryotherapy']","['NSAID use', 'surgical site infection', 'visual analog pain scores (VAS', 'Pain relief', 'Mean postoperative pain scores (VAS', 'median narcotic use in morphine equivalents', 'lung function based on incentive spirometry', 'Postoperative Midline Incision Pain, NSAID or Narcotic Use']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",68.0,0.0342153,"The cryotherapy group was also found to have a lesser incidence of surgical site infection (p = 0.03) and better lung function based on incentive spirometry (p = 0.01) and demonstrated earlier functional recovery based on their ability to perform the sit-to-stand test (p = 0.001).
","[{'ForeName': 'Bharadhwaj', 'Initials': 'B', 'LastName': 'Ravindhran', 'Affiliation': ""Department of General Surgery, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Sendhil', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': ""Department of General Surgery, St. John's Medical College, Bengaluru, India. sendhil1986@gmail.com.""}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Balachandran', 'Affiliation': 'Department of Surgical Gastroenterology, Sakra World Hospital, Bengaluru, India.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Mohan', 'Affiliation': ""Department of General Surgery, St. John's Medical College, Bengaluru, India.""}]",World journal of surgery,['10.1007/s00268-019-05129-1']
1989,32139505,Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy.,"OBJECTIVE


To report safety, pharmacokinetics, exon 53 skipping, and dystrophin expression in golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping.
METHODS


Part 1 was a randomized, double-blind, placebo-controlled, 12-week dose titration of once-weekly golodirsen; part 2 is an ongoing, open-label evaluation. Safety and pharmacokinetics were primary and secondary objectives of part 1. Primary biological outcome measures of part 2 were blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry.
RESULTS


Twelve patients were randomized to receive golodirsen (n = 8) or placebo (n = 4) in part 1. All from part 1 plus 13 additional patients received 30 mg/kg golodirsen in part 2. Safety findings were consistent with those previously observed in pediatric patients with DMD. Most of the study drug was excreted within 4 hours following administration. A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%). Sarcolemmal localization of dystrophin was demonstrated by significantly increased dystrophin-positive fibers (week 48,  p  < 0.001) and a positive correlation (Spearman  r  = 0.663;  p  < 0.001) with dystrophin protein change from baseline, measured by Western blot and immunohistochemistry.
CONCLUSION


Golodirsen was well-tolerated; muscle biopsies from golodirsen-treated patients showed increased exon 53 skipping, dystrophin production, and correct dystrophin sarcolemmal localization.
CLINICALTRIALSGOV IDENTIFIER


NCT02310906.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that golodirsen is safe and Class IV evidence that it induces exon skipping and novel dystrophin as confirmed by 3 different assays.",2020,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","['golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping', 'patients with Duchenne muscular dystrophy', 'pediatric patients with DMD', 'Twelve patients']","['placebo', 'golodirsen']","['blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry', 'dystrophin production', 'dystrophin-positive fibers', 'dystrophin protein expression', 'Safety and pharmacokinetics', 'tolerated; muscle biopsies']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033268'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035380', 'cui_str': 'Reverse Transcription'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0949466', 'cui_str': 'Western Immunoblot'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",12.0,0.315679,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","[{'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Frank', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Schnell', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Akana', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Saleh H', 'Initials': 'SH', 'LastName': 'El-Husayni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody A', 'Initials': 'CA', 'LastName': 'Desjardins', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Morgan', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Charleston', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Sardone', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Domingos', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dickson', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Straub', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Guglieri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Servais', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK. f.muntoni@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009233']
1990,32211987,Medical practice and placebo response: an inseparable bond?,"The history of medicine and the history of placebo are closely intertwined. To understand placebo and its effects this article gives a brief overview about its history, the possible mechanisms of action and its counterpart, nocebo.The Catholic Church used placebo around the sixteenth century for the separation from real and incorrect exorcisms, but it needed Henry Beecher during World War II to quantify the placebo effect as control arm in well-designed studies.Until today the different mechanisms of action of placebo remain poorly researched. Understanding them would allow its effect to be modulated to better serve in research and clinical settings. Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.The counterpart, nocebo, is even less investigated, even it is commonly observed as adverse effects during medical treatments.Conclusion: Placebo and nocebo are both underestimated and underresearched in their value. Through further investigation doctors could strengthen the placebo response and prevent adverse effects to help their patients at low cost. These techniques would benefit the patient-doctor relationship, which is the alter of a trust-based successful therapy.",2020,"Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.177075,"Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jilch', 'Affiliation': 'Medical University of Vienna, Vienna, Austria. n1104225@students.meduniwien.ac.at.'}, {'ForeName': 'Ruken', 'Initials': 'R', 'LastName': 'Sel', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Shahrokh F', 'Initials': 'SF', 'LastName': 'Shariat', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01626-9']
1991,31409751,Dog owner's accuracy measuring different volumes of dry dog food using three different measuring devices.,"Prior research demonstrates significant inaccuracy when repeatedly measuring the same amount of dry dog food using a dry-food measuring cup, bringing into question the accuracy of measuring devices. This study aimed to determine dog owners' accuracy when measuring different volumes of dry dog food using different types of measuring devices. One hundred dog owners, randomly assigned one of three measuring devices (a one-cup dry-food measuring cup, a two-cup graduated-liquid measuring cup or a two-cup commercial food scoop), were asked to measure ¼, ½ and 1 cup of dry dog food. Accuracy was assessed with an electronic gram scale by comparing measured volumes with the correct weight in grams. Individual accuracy ranged from -47.83% to 152.17% across devices and volumes. Measuring accuracy was found to be associated with the volume of food measured (p<0.001) and the type of measuring device used (p<0.001). Findings highlight approaches for decreasing excess intake of calories by dogs, including promotion of tactics to improve measurement accuracy (eg, gram scales, volume-calibrated dry-food measuring devices), especially for measuring small volumes.",2019,Measuring accuracy was found to be associated with the volume of food measured (p<0.001) and the type of measuring device used (p<0.001).,['One hundred dog owners'],"['three measuring devices (a one-cup dry-food measuring cup, a two-cup graduated-liquid measuring cup or a two-cup commercial food scoop']",['Individual accuracy'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0016495', 'cui_str': 'Food, Dried'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0183177', 'cui_str': 'Scoop'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0349349,Measuring accuracy was found to be associated with the volume of food measured (p<0.001) and the type of measuring device used (p<0.001).,"[{'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Coe', 'Affiliation': 'Department of Population Medicine, University of Guelph, Ontario Veterinary College, Guelph, Ontario, Canada jcoe@uoguelph.ca.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rankovic', 'Affiliation': 'Department of Clinical Studies, University of Guelph, Ontario Veterinary College, Guelph, Ontario, Canada.'}, {'ForeName': 'Tara R', 'Initials': 'TR', 'LastName': 'Edwards', 'Affiliation': 'VCA Tri Lake Animal Hospital and Referral Centre, Lake Country, British Columbia, Canada.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Parr', 'Affiliation': 'Department of Clinical Studies, University of Guelph, Ontario Veterinary College, Guelph, Ontario, Canada.'}]",The Veterinary record,['10.1136/vr.105319']
1992,31374537,Number line unidimensionality is a critical feature for promoting fraction magnitude concepts.,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training. Here, we asked whether unidimensionality is necessary for the number line to promote fraction magnitude concepts and whether left-to-right orientation and labeled endpoints are sufficient. We randomly assigned second- and third-graders (N = 148) to one of four 15-min one-on-one, experimenter-led trainings. Three number line trainings had identical scripts, where the experimenter taught children to segment and shade the number line along the horizontal dimension. The number line conditions varied only in the vertical dimension of the training number line: pure unidimensional number line (17.5 cm horizontal line), hybrid unidimensional number line (17.5 × 0.6 cm rectangle), and square number line (17.5 × 17.5 cm). In the area model condition, children were taught to segment and shade a square (17.5 × 17.5 cm) along both dimensions. The conditions significantly differed in posttest fraction magnitude comparison accuracy (a transfer task), controlling for pretest accuracy, reading achievement, and age. In preregistered analyses, the hybrid unidimensional number line condition significantly outperformed the square area model condition and the square number line condition. In exploratory analyses accounting for training protocol fidelity, these results held and the pure unidimensional number line also outperformed the area model condition on fraction magnitude comparisons. We argue that unidimensionality is a critical feature of the number line for promoting fraction magnitude concepts because it aligns with a key concept-that real numbers, including fractions, can be ordered along a single dimension.",2019,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training.",[],[],"['posttest fraction magnitude comparison accuracy (a transfer task), controlling for pretest accuracy, reading achievement, and age']",[],[],"[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.0200516,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gunderson', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA. Electronic address: liz.gunderson@temple.edu.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Hamdan', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Psychology, Boston College, Chestnut Hill, MA 02467, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bartek', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.06.010']
1993,32203176,Neurodevelopmental outcomes at 2 years in term and late preterm newborns enrolled in a trial of hydrocortisone for cardiovascular insufficiency.,,2020,,[],['hydrocortisone'],"['cardiovascular insufficiency', 'Neurodevelopmental outcomes']",[],"[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C1392046', 'cui_str': 'Cardiovascular insufficiency'}]",,0.083248,,"[{'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'MSC10 5590, 1 University of New Mexico, Albuquerque, NM, 87131, USA. Kwatterberg@salud.unm.edu.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0664-7']
1994,32139194,A Randomized Controlled Trial Comparing a Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcomes Following Total Knee Replacement.,"BACKGROUND


The purpose of this randomized controlled trial was to compare the performance of 3 total knee joint replacement (TKJR) designs 6 months after the surgery.
METHODS


Patients were recruited between March 2015 and March 2018. Patients with osteoarthritis consented for TKJR were randomly allocated to a medial stabilized (MS), cruciate retaining (CR), or posterior stabilized (PS) design. Primary outcome measures were self-reported improvement in pain and function 6 months after TKJR, using the Oxford Knee Score. Secondary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, Veterans RAND 12-item Health Survey, Knee Society Score 2011, Timed Up and Go test, and Six-Minute Walk Test. Twelve-month outcomes were also measured.
RESULTS


Ninety participants enrolled, 83 were randomized: PS (n = 26), CR (n = 28), and MS (n = 29) designs. One case withdrew before surgery: planned use of non-study implant; 7 did not complete all outcome measures. No 6-month between-group difference was observed for the primary outcome. A 6-month difference was observed in Knee Society Score 2011 Satisfaction: MS favored over CR and PS. Clinically meaningful 12-month differences in Western Ontario and McMaster Universities Osteoarthritis Index Pain, Function, and Global Subscales were observed: MS favored over CR. Twelve-month differences occurred in Veterans RAND 12-item Health Survey mental well-being, favoring MS and PS over CR.
CONCLUSION


MS prosthesis can be expected to yield similar clinical and functional outcomes to PS and CR designs 6 months after TKJR, and patients were more satisfied with their outcome. Compared with CR, patients with MS prosthesis also reported superior pain, function, and quality-of-life outcomes at 12 months.",2020,"Twelve-month differences occurred in Veterans RAND 12-item Health Survey mental well-being, favoring MS and PS over CR.
","['Patients were recruited between March 2015 and March 2018', 'Patients with osteoarthritis consented for TKJR', 'Ninety participants enrolled, 83 were randomized: PS (n = 26), CR (n = 28), and MS (n = 29) designs']","['Total Knee Replacement', 'total knee joint replacement (TKJR', 'Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design', 'medial stabilized (MS), cruciate retaining (CR), or posterior stabilized (PS) design']","['superior pain, function, and quality-of-life outcomes', 'Knee Society Score 2011 Satisfaction: MS', 'Western Ontario and McMaster Universities Osteoarthritis Index, Veterans RAND 12-item Health Survey, Knee Society Score 2011, Timed Up and Go test, and Six-Minute Walk Test', 'self-reported improvement in pain and function 6 months after TKJR, using the Oxford Knee Score', 'Veterans RAND 12-item Health Survey mental well-being, favoring MS and PS over CR', 'Western Ontario and McMaster Universities Osteoarthritis Index Pain, Function, and Global Subscales']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0022748', 'cui_str': 'Knee Prosthesis'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",90.0,0.154553,"Twelve-month differences occurred in Veterans RAND 12-item Health Survey mental well-being, favoring MS and PS over CR.
","[{'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Dowsey', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Gould', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Spelman', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Pandy', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Choong', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.085']
1995,31922432,Prophylactic Effects of Intravenous Dexamethasone and Lidocaine on Attenuating Hemodynamic-Respiratory and Pain Complications in Children Undergoing Cleft Palate Repair Surgery With General Anesthesia.,"This study aimed to compare the prophylactic effects of intravenous (IV) dexamethasone and lidocaine on hemodynamic condition, respiratory complications, pain control, and vomit incidence following cleft palate repair surgery. This double-blind randomized controlled trial was carried out on 87 children assigned to three groups. Prior to anesthesia, subjects in groups D and L received 0.2 and 1 mg/kg IV dexamethasone and lidocaine, respectively. Moreover, group C received placebo in a similar condition. The outcome variables were recorded prior to the surgery and then every 15 minutes during the surgical and recovery time. Mean heart rate (HR), mean arterial blood pressure (MABP), and mean end-tidal carbon dioxide (ETCO2) during the surgical time were not significantly different between dexamethasone and lidocaine groups. Dexamethasone significantly improved the level of blood oxygen saturation (SPO2) during the recovery time. Nevertheless, MABP in recovery time did not significantly decrease in the dexamethasone group. There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups. Premedication with both IV dexamethasone and lidocaine provided similar stable hemodynamic and respiratory conditions during the surgical time. However, the use of dexamethasone developed more desirable effects on HR and SPO2 than administration of lidocaine during the recovery time. Both drugs significantly lessened postoperative pain compared to the placebo group at this time.",2020,"There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups.","['87 children assigned to three groups', 'cleft palate repair surgery', 'Children Undergoing Cleft Palate Repair Surgery']","['Dexamethasone', 'Dexamethasone and Lidocaine', 'placebo', 'intravenous (IV) dexamethasone and lidocaine', 'dexamethasone', 'lidocaine', 'dexamethasone and lidocaine']","['MABP in recovery time', 'postoperative pain', 'level of blood oxygen saturation (SPO2', 'Mean heart rate (HR), mean arterial blood pressure (MABP), and mean end-tidal carbon dioxide (ETCO2) during the surgical time', 'Hemodynamic-Respiratory and Pain Complications', 'respiratory complications, pain score, and vomiting incidence', 'stable hemodynamic and respiratory conditions', 'hemodynamic condition, respiratory complications, pain control, and vomit incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0192086', 'cui_str': 'Uranorrhaphy for cleft palate repair (procedure)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}]",87.0,0.154139,"There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups.","[{'ForeName': 'Dorna', 'Initials': 'D', 'LastName': 'Kheirabadi', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shafa', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hirmanpour', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zareh', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of pain & palliative care pharmacotherapy,['10.1080/15360288.2019.1706691']
1996,31326680,Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial.,"Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.",2019,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","['atrial fibrillation at primary care visits', '16,000 patients in each arm', 'individuals 65 years or older during primary care visits', 'eligible patients who agree to participate during office visits using a single-lead ECG device']",['AF screening'],"['new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0527347,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA. Electronic address: slubitz@mgh.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.011']
1997,32442189,Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.,"BACKGROUND


Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa.
METHODS AND FINDINGS


In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection.
CONCLUSIONS


In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721798.",2020,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","['women living with HIV in South Africa', 'Participant median age was 31 years, and 95% had 1 or more prior pregnancies', 'male partners', 'We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women', 'Cape Town, South Africa', 'eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART', 'Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent', 'Women living with HIV (WLHIV']","['Hormonal contraceptives', 'levonorgestrel intrauterine system', 'injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC', 'levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD']","['39 serious adverse events (SAEs); SAEs', 'gVL or pVL and had low levels of contraceptive failure and associated PID', 'Mean hemoglobin change', 'elective discontinuation', 'hemoglobin levels', 'pVL, RTI, and pregnancy testing', 'genital tract HIV viral load (gVL) and sexual transmission risk', 'mean pVL', 'gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation', 'expulsion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009866', 'cui_str': 'Contraception failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031406', 'cui_str': 'Phenindione'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]",71.0,0.642316,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Todd', 'Affiliation': 'Maternal and Child Health and Nutrition Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, City University of New York School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Nontokozo', 'Initials': 'N', 'LastName': 'Langwenya', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Institute for Health Care Policy and Aging Research, Rutgers University, Piscataway, New Jersey, United States of America.'}, {'ForeName': 'Pai-Lien', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Global Population and Health Research Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Petro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003110']
1998,32438905,Thigh musculature stiffness during active muscle contraction after anterior cruciate ligament injury.,"BACKGROUND


Altered motor unit (MU) activity has been identified after anterior cruciate ligament (ACL) injury, but its effect on muscle tissue properties is unknown. The purpose of this study was to compare thigh musculature muscle stiffness between control and ACL-injured subjects.
METHODS


Thirty ACL-injured subjects and 25 control subjects were recruited. Subjects completed a randomized protocol of isometric contractions while electromyography (EMG) signals were recorded. Three maximum voluntary isometric contractions (MVIC) determined peak force for 10 and 25% MVIC trials. Shear wave elastography was captured during each 10 and 25% MVIC trials.
RESULTS


Differences in muscle stiffness were assessed between limbs and groups. 12 months post-surgery had higher stiffness for VM 0% MVIC, VL 0 and 10% MVIC, and ST 10 and 25% MVIC (all p ≤ 0.04).
CONCLUSION


Thigh musculature stiffness changed throughout rehabilitation and remained altered at 12 months after ACL reconstruction.",2020,12 months post-surgery had higher stiffness for VM,"['control and ACL-injured subjects', 'anterior cruciate ligament injury', 'Thirty ACL-injured subjects and 25 control subjects were recruited', 'anterior cruciate ligament (ACL) injury']",[],"['maximum voluntary isometric contractions (MVIC) determined peak force', 'muscle stiffness', 'Shear wave elastography', 'thigh musculature muscle stiffness', 'Thigh musculature stiffness', 'higher stiffness for VM']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",[],"[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205250', 'cui_str': 'High'}]",30.0,0.0278514,12 months post-surgery had higher stiffness for VM,"[{'ForeName': 'April L', 'Initials': 'AL', 'LastName': 'McPherson', 'Affiliation': 'Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Bates', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Clifton R', 'Initials': 'CR', 'LastName': 'Haider', 'Affiliation': 'Special Purpose Processor Development Group, Department of Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Hewett', 'Affiliation': 'Sparta Science, Menlo Park, CA, USA.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Schilaty', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA. Schilaty.nathan@mayo.edu.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03342-x']
1999,32442781,The impact of exposure therapy on stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD.,"Although cognitive behavioral interventions improve attitudes toward mental health treatment and reduce stigma, little is known about which types of attitudes change, or how this change occurs. Active duty soldiers with PTSD (N = 162) were randomized to 10 sessions of exposure therapy or a waitlist. Soldiers were assessed for PTSD and completed measures of stigma and attitudes towards mental health services before randomization and after 5- and 10- sessions of therapy. At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist. There were significant indirect effects from treatment to changes in stigma and attitudes towards mental health treatment through changes in PTSD symptoms at post-treatment. There was also a significant indirect effect from treatment to changes in stigma at post-treatment through changes in attitudes towards mental health treatment at mid-treatment, suggesting attitude change may occur first. Baseline characteristics did not moderate treatment's change in stigma or attitudes. Improvements in PTSD symptoms and positive changes in attitudes towards mental health treatment appear to separately predict later reductions in stigma.",2020,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","['stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD', 'Active duty soldiers with PTSD (N\xa0=\xa0162']","['exposure therapy', 'cognitive behavioral interventions', 'exposure therapy or a waitlist']","['stigma and attitudes towards mental health services', 'openness to talking about mental health problems', 'stigma or attitudes']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",162.0,0.0278219,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States. Electronic address: greg.reger@va.gov.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; Duke University Medical Center, Center for Aging and Human Development, 2020 W. Main St., Durham, NC, 27707, United States.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), 1660 S. Columbian Way, Seattle, WA, 98108, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.005']
2000,32442828,Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved oxygenation.,"BACKGROUND


We previously reported in a randomised trial that early intravenous paracetamol accelerated contraction of ductus arteriosus in very preterm infants (<32 gestation weeks).
AIMS


To monitor sequentially paracetamol effects on the blood pressure and brain tissue oxygenation in the infants participating the trial.
METHODS


In a double-blind trial, intravenous paracetamol or placebo was infused to 48 very premature infants starting within 24 h of birth for four days. Besides the ductus arteriosus, we systematically measured blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE) during the study period.
RESULTS


Compared to the placebo, the paracetamol loading dose transiently decreased the arterial blood pressure. During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants. Additionally, the cFTOE values were lower in the paracetamol group during the study without statistical significance. All infants with closed ductus had higher tissue oxygenation and a lower cFTOE than infants with open ductus.
CONCLUSIONS


Paracetamol caused modest haemodynamic effects and increased cerebral oxygenation. They were mostly due to early contraction of ductus. Additional direct drug-effects in brain are not ruled-out.",2020,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","['very preterm infants (<32 gestation weeks', '48 very premature infants starting within 24\u202fh of birth for four days', 'infants participating the trial']","['paracetamol', 'intravenous paracetamol or placebo', 'Paracetamol', 'placebo']","['haemodynamic effects', 'haemodynamic changes and improved oxygenation', 'tissue oxygenation', 'arterial blood pressure', 'blood pressure and brain tissue oxygenation', 'blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE', 'cerebral oxygenation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",48.0,0.459725,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Härmä', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland. Electronic address: outi.aikio@ppshp.fi.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Härkin', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Valkama', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}]",Early human development,['10.1016/j.earlhumdev.2020.105042']
2001,32443412,Micronutrient and Inflammation Status Following One Year of Complementary Food Supplementation in 18-Month-Old Rural Bangladeshi Children: A Randomized Controlled Trial.,"Background:  Four fortified complementary food supplements (CFSs) in a randomized controlled trial (RCT) were found to improve childhood linear growth in rural Bangladesh. We hypothesized children receiving these supplements would have improved micronutrient status.  Methods:  In the RCT, we assessed hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP) at endline (18 mo) in a subsample of children ( n  = 752). The impact of supplementation on mean concentrations and the prevalence of nutrient deficiency and inflammation were evaluated using adjusted generalized estimating equation (GEE) linear and log-binomial regression models.  Results:  In the control arm at age 18 months, 13% of children were anemic (hemoglobin < 110 g/L), and 6% were iron (inflammation-adjusted ferritin < 12 μg/L), 8% vitamin A (inflammation-adjusted retinol < 0.70 μmol/L), and 5% zinc (zinc < 9.9 μmol/L) deficient. The prevalence of inflammation by CRP (>5 mg/L) and AGP (>1 g/L) was 23% and 66%, respectively, in the control group. AGP trended lower in CFS groups ( p  = 0.04), while CRP did not. Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  Conclusions:  CFSs improved iron status and vitamin A concentrations and lowered inflammation in a context of low underlying nutrient deficiency but high inflammation.",2020,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","['rural Bangladesh', '18-Month-Old Rural Bangladeshi Children']","['fortified complementary food supplements (CFSs', 'Complementary Food Supplementation']","['AGP', 'Micronutrient and Inflammation Status', 'hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP', 'mean concentrations and the prevalence of nutrient deficiency and inflammation', 'Mean ferritin', 'hemoglobin', 'prevalence of inflammation by CRP']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",,0.152667,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Margia', 'Initials': 'M', 'LastName': 'Arguello', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}]",Nutrients,['10.3390/nu12051452']
2002,32443433,The Effects on Immune Function and Digestive Health of Consuming the Skin and Flesh of Zespri ®  SunGold Kiwifruit ( Actinidia Chinensis  var.  Chinensis  'Zesy002') in Healthy and IBS-Constipated Individuals.,"Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that results in constipation (IBS-C) or diarrhoea with abdominal pain, flatulence, nausea and bloating. Kiwifruit ( Actinidia  spp.) are nutrient-dense fruit with a number of reported health benefits that include lowering glycaemic response, improving cardiovascular and inflammatory biomarkers, and enhancing gut comfort and laxation. This study investigated the effect of consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var.  chinensis  'Zesy002') with or without skin on cytokine production and immune and gut health in healthy people and those with IBS-C symptoms. This study enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C). Participants were randomized to consume either three kiwifruit without eating the skin or three kiwifruit including the skin for 4 weeks each, with a 4 week washout in between each intervention. There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001). The kiwifruit interventions increased bowel frequency and significantly reduced the gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores for both participant groups. We have demonstrated that consuming the skin of SunGold kiwifruit might have beneficial effects on gastrointestinal health that are not produced by consuming the flesh alone.",2020,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","['Healthy and IBS-Constipated Individuals', 'healthy people and those with IBS-C symptoms', 'enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C']","['kiwifruit without eating the skin or three kiwifruit including the skin', 'consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var']","['Irritable bowel syndrome (IBS', 'pro-inflammatory cytokine, TNF-α', 'gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores', 'cytokine production and immune and gut health', 'bowel frequency']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0949891', 'cui_str': 'Kiwi Plant'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",38.0,0.0379497,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Eady', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Wallace', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Duncan I', 'Initials': 'DI', 'LastName': 'Hedderley', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Bentley-Hewitt', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Butts', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}]",Nutrients,['10.3390/nu12051453']
2003,32443684,Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial.,"BACKGROUND


Post-natal gut maturation in infants interrelates maturation of the morphology, digestive, and immunological functions and gut microbiota development. Here, we explored both microbiota development and markers of gut barrier and maturation in healthy term infants during their early life to assess the interconnection of gut functions during different infant formulae regimes.
METHODS


A total of 203 infants were enrolled in this randomized double-blind controlled trial including a breastfed reference group. Infants were fed starter formulae for the first four weeks of life, supplemented with different combination of nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp.  Lactis ) and prebiotics (Bovine Milk-derived Oligosaccharides-BMOS)) and subsequently fed the control formula up to eight weeks of life. Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin were measured in feces at one, two, four, and eight weeks.
RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups. Elastase and AAT levels were closer to levels observed in breastfed infants. No differences were observed for neopterin. Global differences between the bacterial communities of all groups were assessed by constrained multivariate analysis with hypothesis testing. The canonical correspondence analysis (CCA) at genus level showed overlap between microbiota profiles at one and four weeks of age in the BMOS supplemented formula group with the breastfed reference, dominated by bifidobacteria. Microbiota profiles of all groups at four weeks were significantly associated with the calprotectin levels at 4 (CCA,  p  = 0.018) and eight weeks of age (CCA,  p  = 0.026).
CONCLUSION


A meaningful correlation was observed between changes in microbiota composition and gut maturation marker calprotectin. The supplementation with BMOS seems to favor gut maturation closer to that of breastfed infants.",2020,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","['healthy term infants', 'A total of 203 infants']","['nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp', 'Supplemented Infant Formulae', 'prebiotics (Bovine Milk-derived Oligosaccharides-BMOS']","['microbiota composition and gut maturation marker calprotectin', 'Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin', 'Intestinal Biomarkers and Microbiota', 'neopterin', 'calprotectin levels', 'mean calprotectin levels', 'Elastase and AAT levels', 'Microbiota profiles']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0052586', 'cui_str': 'ATA protocol'}]",203.0,0.0733011,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","[{'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Castanet', 'Affiliation': 'CIC INSERM U1404, Department of Pediatric, Rouen University Hospital Charles Nicolle, 76031 Rouen, France.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Costalos', 'Affiliation': 'Department of Neonatology, Alexandra Regional General Hospital, 11528 Athens, Greece.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Hascoet', 'Affiliation': 'Department of Neonatology, Maternite Regionale, CHRU Nancy, 54035 Nancy, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sprenger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Brüssow', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'De Groot', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Steenhout', 'Affiliation': 'Nestlé Health Science, 1066 Epalinges, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pecquet', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Benyacoub', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Department of Neonatology, University Hospital Croix Rousse, Hospices Civils de Lyon, 69317 Lyon France.'}]",Nutrients,['10.3390/nu12051481']
2004,32444058,Thermo-therapy and cryotherapy to decrease the symptoms of restless leg syndrome during the pregnancy: A randomized clinical trial.,"BACKGROUND AND PURPOSE


Restless legs syndrome (RLS) is a common sensory-motor disorder among the pregnant women. The aim of this study is to compare the impacts of two methods of immersion of legs in cold and warm water on the RLS symptoms among the pregnant women.
METHODS


This randomized clinical trial was conducted on 80 pregnant women with RLS who referred to Taleghani educational-therapy center. After obtaining their informed consent, they were selected by accessible method and randomly allocated into group 1 (warm water) and group 2 (cold water). Group 1 were asked to put their legs in cold water for 10 min every night for 2 weeks. The group 2 put their legs in warm water under the same condition. The severity of RLS was measured before and after the study. Data analysis was conducted using descriptive as well as the analytical statistics such as Chi-square, independent T test, pair T test, Mann-Whitney U, Wilcoxon and covariance.
RESULTS


After intervention, mean RLS of the cold water group was11.02 ± 4.93; while this mean was 13.50 ± 4.74 in the warm water group. The difference between the two groups was significant (p = 0.017). Results also revealed that the severity of RLS symptoms at the end of the treatment was different from the beginning of the research in both groups (p = 0.001). The intervention with both warm and cold water declined the RLS symptoms among pregnant women.
CONCLUSION


The warm and cold water can be used for this purpose depending on the women's preference. However, this article recommends the cold water for more reducing of symptoms.",2020,The difference between the two groups was significant (p = 0.017).,"['80 pregnant women with RLS who referred to Taleghani educational-therapy center', 'pregnant women']",['Thermo-therapy and cryotherapy'],"['severity of RLS', 'mean RLS', 'severity of RLS symptoms', 'symptoms of restless leg syndrome', 'RLS symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0204583', 'cui_str': 'Educational therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.0644877,The difference between the two groups was significant (p = 0.017).,"[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Jafarimanesh', 'Affiliation': 'School of Nursing, School of Medicine, Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: Jafarimanesh@arakmu.ac.ir.'}, {'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Vakilian', 'Affiliation': 'Department of Midwifery, School of Medicine, Traditional and Complementary Medicine Research Center(TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: dr.kvakilian@arakmu.ac.ir.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Mobasseri', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Imam Khomeini Street, Taleghani Hospital, Arak, Iran. Electronic address: shirinmobaseri@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102409']
2005,32444091,Long-term ACE inhibition in Alport syndrome: are the benefits worth the risks?,"Gross et al. present results of the EARLY PRO-TECT trial, a randomized controlled trial of ramipril versus placebo in children with early-stage Alport syndrome. Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.",2020,"Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.","['children with Alport syndrome', 'Alport syndrome', 'children with early-stage Alport syndrome']","['ramipril', 'placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0806223,"Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.","[{'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Rheault', 'Affiliation': ""Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, USA. Electronic address: rheau002@umn.edu.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Smoyer', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio, USA.""}]",Kidney international,['10.1016/j.kint.2020.01.030']
2006,32444133,Comparison of two methods for obtaining and transporting corneal samples in suspected infectious keratitis.,"BACKGROUND AND PURPOSE


The purpose of this study is to compare two alternative methods of collecting and transporting media for the diagnosis of corneal ulcers, as not all clinical settings have conventional culture materials and transport media available.
METHODS


In this open-label, prospective, comparative, and randomized study, patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth. The order of each collection method was randomized. The samples were processed by standard methods, comparing the positivity frequencies for both by parametric and nonparametric tests, according to normality criteria.
RESULTS


Corneal infiltrates from 40 eyes of 40 patients were analyzed. Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258). The overall growth rate of the two methods combined was not higher than with the swab alone. The results obtained with a swab were not influenced by the collection sequence (P=0.112); however, the positivity rate was significantly higher when the sample taken with the needle was performed first (P=0.046).
CONCLUSIONS


The single sample Eswab method of collection and transportation for the diagnosis of high risk corneal ulcers is a valid alternative and can be used in cases in which, for various reasons, there is no access to the full set of traditional culture materials.",2020,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"['patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth', 'Corneal infiltrates from 40 eyes of 40 patients were analyzed', 'suspected infectious keratitis']",['collecting and transporting media'],"['Culture positivity rate', 'positivity rate', 'overall growth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0972753', 'cui_str': 'Transport medium'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C1550050', 'cui_str': 'Amies transport medium'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0853336', 'cui_str': 'Infiltrate of cornea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0972753', 'cui_str': 'Transport medium'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",40.0,0.0360887,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chang-Sotomayor', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: meilinchangsotomayor@gmail.com.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Llorens Bellés', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: llorens.victor@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Latasiewicz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: martuska1111@gmail.com.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torras-Sanvicens', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: JTORRAS@clinic.cat.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Blanco-Domínguez', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: ire_blanco@hotmail.com.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sabater-Cruz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: noelia.sabater@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sainz-de-la-Maza', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: MSAINZ@clinic.cat.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Mestres', 'Affiliation': 'Microbiology Department Hospital Clínic de Barcelona, ISGlobal, Carrer de Villarroel, 170, 08036 Barcelona, Spain. Electronic address: JOBOSCH@clinic.cat.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Palma-Carvajal', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: fpalmac@gmail.com.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2019.10.010']
2007,32444149,Transition to forefoot strike reduces load rates more effectively than altered cadence.,"BACKGROUND


Excessive vertical impacts at landing are associated with common running injuries. Two primary gait-retraining interventions aimed at reducing impact forces are transition to forefoot strike and increasing cadence. The objective of this study was to compare the short- and long-term effects of 2 gait-retraining interventions aimed at reducing landing impacts.
METHODS


A total of 39 healthy recreational runners using a rearfoot strike and a cadence of ≤170 steps/min were randomized into cadence (CAD) or forefoot strike (FFS) groups. All participants performed 4 weeks of strengthening followed by 8 sessions of gait-retraining using auditory feedback. Vertical average load rates (VALR) and vertical instantaneous load rates (VILR) were calculated from the vertical ground reaction force curve. Both cadence and foot strike angle were measured using 3D motion analysis and an instrumented treadmill at baseline and at 1 week, 1 month, and 6 months post retraining.
RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term. Foot strike angle in the FFS group changed from 14.2° dorsiflexion at baseline to 3.4° plantarflexion, with changes maintained long term. The CAD group exhibited significant reduction only in VALR (16%) and only at 6 months. Both groups had significant and similar increases in cadence at all follow-ups (CAD, +7.2% to 173 steps/min; and FFS, +6.1% to 172 steps/min).
CONCLUSION


Forefoot strike gait-retraining resulted in significantly greater reductions in VALR and similar increases in cadence compared to cadence gait-retraining in the short and long term. Cadence gait-retraining resulted in small reductions in VALR at only the 6-month follow-up.",2020,"RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term.",['39 healthy recreational runners using a rearfoot strike and a cadence of ≤170 steps/min were randomized into'],"['2 gait-retraining interventions', 'cadence (CAD) or forefoot strike (FFS', 'gait-retraining using auditory feedback', 'Cadence gait-retraining']","['VALR', 'VILR', 'Vertical average load rates (VALR) and vertical instantaneous load rates (VILR', 'Foot strike angle', 'cadence']","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",39.0,0.0737562,"RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Futrell', 'Affiliation': 'Department of Physical Therapy, Springfield College, Springfield, MA 01109, USA; Spaulding National Running Center, Harvard Medical School, Cambridge, MA 02138, USA. Electronic address: efutrell@springfieldcollege.edu.'}, {'ForeName': 'K Douglas', 'Initials': 'KD', 'LastName': 'Gross', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, Boston, MA 02129, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Reisman', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mullineaux', 'Affiliation': 'School of Sport and Exercise Science, University of Lincoln, Brayford Pool, Lincoln, Lincolnshire, Brayford Pool, LN6 7TS, UK.'}, {'ForeName': 'Irene S', 'Initials': 'IS', 'LastName': 'Davis', 'Affiliation': 'Spaulding National Running Center, Harvard Medical School, Cambridge, MA 02138, USA; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, USA.'}]",Journal of sport and health science,['10.1016/j.jshs.2019.07.006']
2008,32443290,Total and hidden blood loss between open posterior lumbar interbody fusion and transforaminal lumbar interbody fusion by Wiltse approach.,"The purpose of this study was to calculate and compare the volume of hidden blood loss (HBL) and perioperative blood loss between open posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) by Wiltse approach.We retrospectively analyzed 143 patients between March 2017 and December 2017, they were randomly divided into PLIF group and TLIF group. The following information were collected on admission: patient's age, gender, height, weight, body mass index (BMI), surgery levels, surgical time, duration time, disorder type, intraoperative bleeding, wound drainage, visual analog scale (VAS) scores, neurological complications, transfusion rate. Preoperative and postoperative hematocrit (Hct) were recorded in order to calculate total blood loss (TBL) according to Gross's formula. To calculate each patient's HBL, chi-square test and Student's t test were used to analyze data.Patients in PLIF had a mean TBL of 1144 ± 356 mL, and the mean HBL was 486 ± 203 mL, 43.9 ± 16.2% of the TBL. While patients in TLIF, the mean TBL was 952 ± 303 mL, and the mean HBL was 421 ± 178 mL, 44.7 ± 17.0% of the TBL. Hence, there was significant difference in TBL and HBL between 2 groups, respectively (P = .000, P = .044). However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The volume of HBL is lower in open TLIF by Wiltse approach than that in PLIF, which may be a large proportion of TBL in posterior lumbar fusion surgery. Comprehensive understanding of HBL can contribute to keep patient safety and better to rehabilitation in perioperative.",2020,"However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The",['143 patients between March 2017 and December 2017'],"['open posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF', 'PLIF group and TLIF']","['ratio of the HBL', 'weight, body mass index (BMI), surgery levels, surgical time, duration time, disorder type, intraoperative bleeding, wound drainage, visual analog scale (VAS) scores, neurological complications, transfusion rate', 'Preoperative and postoperative hematocrit (Hct', 'TBL and HBL', 'Total and hidden blood loss', 'volume of hidden blood loss (HBL) and perioperative blood loss', 'volume of HBL', 'total blood loss (TBL']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205262', 'cui_str': 'Occult'}]",143.0,0.0228292,"However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Zhongyang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics Surgery, West China Hospital, Sichuan University, No. 37 Guoxue St. of Wuhou District, Chengdu 610041.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Library, Southwest Medical University, No. 1 Xianglin Road of Longma District, Luzhou 646000, Sichuan, China.'}, {'ForeName': 'Xinggui', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Lipeng', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Daxiong', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}]",Medicine,['10.1097/MD.0000000000019864']
2009,32443302,Analgesia for spinal anesthesia positioning in elderly patients with proximal femoral fractures: Dexmedetomidine-ketamine versus dexmedetomidine-fentanyl.,"Elderly patients with femoral fractures are anticipated to endure the most pain caused by positional changes required for spinal anesthesia. To improve pain relief, we compared the analgesic effects of intravenous dexmedetomidine-ketamine and dexmedetomidine-fentanyl combinations to facilitate patient positioning for spinal anesthesia in elderly patients with proximal femoral fractures. Forty-six patients were randomly assigned to two groups and received either 1 mg/kg of intravenous ketamine (group K) or 1 μg/kg of intravenous fentanyl (group F) concomitant with a loading dose of dexmedetomidine 1 μg/kg over 10 minutes, then dexmedetomidine infusion only was continued at 0.6 μg/kg/h for following 20 minutes, and titrated at a rate of 0.2 to 0.6 μg/kg/h until the end of surgery. After completion of the infusion of either ketamine or fentanyl, the patients were placed in the lateral position with the fracture site up. The pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation) was used to describe the pain intensity in each step during the procedure (lateral positioning, hip flexion, and lumbar puncture), and quality score (0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion) was used to describe the quality of posture. Group K showed a median pain score of 0 (0-1), 0 (0-0) and 0 (0-0) in lateral positioning, hip flexion and lumbar puncture, respectively, while group F showed a score of 3 (2.75-3), 3 (2-3) and 0 (0-1), respectively. The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups. The administration of dexmedetomidine-ketamine showed a greater advantage in reducing pain intensity and increasing the quality with patient positioning during spinal anesthesia in elderly patients with proximal femoral fractures, without any serious adverse effects.",2020,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","['elderly patients with proximal femoral fractures', 'Elderly patients with femoral fractures', 'Forty-six patients']","['dexmedetomidine-fentanyl combinations', 'dexmedetomidine-ketamine', 'Dexmedetomidine-ketamine', 'Analgesia', 'dexmedetomidine-fentanyl', 'fentanyl (group F) concomitant with a loading dose of dexmedetomidine', 'intravenous ketamine', 'ketamine or fentanyl', 'dexmedetomidine']","['median pain score', 'pain relief', 'hip flexion', 'quality scores of spinal anesthesia positioning', 'pain intensity', 'pain score in lateral positioning', 'pain score', 'bradycardia, hypotension, and desaturation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",46.0,0.0817178,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","[{'ForeName': 'Ki Hwa', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Inje University Haeundae Paik Hospital, Haeundaegu, Busan, Republic of Korea.'}, {'ForeName': 'Soo Jee', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Se Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyunseong', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Dae Seok', 'Initials': 'DS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Yong Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yei Heum', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyojoong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020001']
2010,32443306,Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina.,"INTRODUCTION


Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA.
METHODS


A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA.",2020,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","['unstable angina', '60 patients diagnosed with UA', 'patients with UA']","['Luofengning granule', 'LFN-G treatment', 'LFN-G', 'placebo']","['Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4', 'incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death']","[{'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",60.0,0.0824664,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatology, Tianjin Third Central Hospital, Tianjin.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'School of Life Science.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}]",Medicine,['10.1097/MD.0000000000020025']
2011,32443319,Evaluation and ultrastructural changes of amniotic membrane fragility after UVA/riboflavin cross-linking and its effects on biodegradation.,"This study aims to evaluate the changes of fragility and ultrastructure of amniotic membrane after cross-linking by UVA/riboflavin.Forty-nine fresh amniotic membranes were randomly divided into 3 groups. Eighteen were in group A (CX group) and immersed in 0.1% riboflavin solution for 10 min for UVA/riboflavin cross-linking. Sixteen were in group B (B2 group), soaked for 10 min with 0.1% riboflavin. After soaking, membranes in group A and B were transferred into corneal preservation solution. Fifteen pieces were in group C, directly into corneal preservation solution. The biomechanical and ultrastructural changes of the amniotic tissue before and after cross-linking were examined (CX group = 13, B2 group = 11, C group = 15). The amniotic membrane tissue of group A (n = 5) and B (n = 5) was transplanted into 16 eyes of the rabbits, respectively, and the dissolution time of the amniotic membrane tissue was investigated.After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength. Also, the collagen fibers showed coarse and bamboo-like changes. In group A, amniotic membranes began to dissolve 4 weeks after conjunctiva transplantation, and all amniotic membranes were dissolved and absorbed 6 weeks after conjunctiva transplantation. In group B, some amniotic membrane tissues were still visible 6 weeks after conjunctiva transplantation.This study suggested that after amniotic membrane cross-linking, the brittleness was increased, the hardness was enhanced, and the morphology of the collagen fiber was changed. The cross-linked amniotic membrane showed resistance to tissue dissolution.",2020,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.",['Forty-nine fresh amniotic membranes'],"['UVA/riboflavin', 'soaked for 10\u200amin with 0.1% riboflavin', 'riboflavin solution for 10\u200amin for UVA/riboflavin']","['tensile strength', 'elastic modulus of the low-stress area of the amniotic membrane (Elow', 'fragility and ultrastructure of amniotic membrane', 'amniotic membrane tissues']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0041623', 'cui_str': 'ultrastructure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",15.0,0.0229728,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.","[{'ForeName': 'Chenming', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': ""People's Hospital of Taierzhuang District, Zaozhuang, China.""}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Jinan Second People's Hospital.""}]",Medicine,['10.1097/MD.0000000000020091']
2012,32444035,Effects of hydroalcoholic extract of Berberis Integerrima on the anthropometric indices and metabolic profile in active rheumatoid arthritis patients.,"OBJECTIVES


Since, the main cause of death in Rheumatoid arthritis (RA) patients is the presence of type 2 diabetes, abnormal increase in blood lipids, blood pressure and obesity, the aim of this study was to assess the effects of Barberry on the anthropometric indices and metabolic profile in patients with RA.
DESIGN


present study was a double-blinded, placebo-controlled randomized clinical trial.
SETTING


70 active RA patients were randomly allocated into intervention or placebo group INTERVENTION: Participants received 6 capsules of 500 mg barberry extract or placebo for 3 months.
MAIN OUTCOME MEASURES


Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors were assessed at baseline and at the end of the trial.
RESULTS


The results of intervention on 62 patients showed that weight, BMI, and conicity index increased in both groups, but this was significant only in the placebo group (p < 0.001). Waist and hip circumference were decreased in the intervention group and increased significantly in the placebo group (p < 0.001). Body fat percent (p = 0.04), LDL-C (p = 0.05) and SBP (p = 0.02) significantly were decreased in the intervention group. The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
CONCLUSIONS


Overall, the results of this study demonstrated that the extract of Berberis Integerrima had beneficial effects on metabolic profile and anthropometric indices in RA patients.",2020,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","['active rheumatoid arthritis patients', 'RA patients', '70 active RA patients', 'patients with RA']","['placebo', '6 capsules of 500 mg barberry extract or placebo', 'hydroalcoholic extract of Berberis Integerrima']","['hip circumference', 'weight, BMI, and conicity index', 'blood lipids, blood pressure and obesity', 'Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors', 'metabolic profile and anthropometric indices', 'anthropometric indices and metabolic profile', 'FBS', 'LDL-C', 'SBP', 'Waist and hip circumference', 'body fat percent']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",70.0,0.376301,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","[{'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: aryaeian.n@iums.ac.ir.'}, {'ForeName': 'Sara Khorshidi', 'Initials': 'SK', 'LastName': 'Sedehi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.nutritionist@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khorshidi', 'Affiliation': ""Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran; Pediatric Gastroenterology, Hepatology and Nutrition Research Center, Research Institute for Children Health, Mofid Children's Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.2065@gmail.com.""}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': 'Department of Clinical Nutrition, Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Zarezadehm@tbzmed.ac.ir.'}, {'ForeName': 'AghaFatemeh', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: hosseini_f@tums.ac.ir.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shahram', 'Affiliation': 'Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahramf@tums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102331']
2013,32444036,A mixed methods evaluation of an individualised yoga therapy intervention for rheumatoid arthritis: Pilot study.,"OBJECTIVES


to explore patients' experiences of an individualised yoga therapy intervention for rheumatoid arthritis (RA), specifically in terms of its acceptability and impact on patient-reported outcomes.
DESIGN


Ten patients took part in a 16 week yoga therapy intervention in a hospital setting, consisting of 10 one-to-one consultations with a yoga therapist followed by two group review sessions. Changes in health (EQ-5D, HADS) were assessed pre- and post-intervention and at 12-month follow-up. In-depth interviews were conducted post-intervention and analysed using thematic analysis.
RESULTS


Attendance of the 1-to-1 sessions was high (98 %) and all participants reported strong commitment to their personalised home practice. There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05). In interviews, all but one participant reported positive changes to their symptoms and several reported reductions in their medication and broader benefits such as improved sleep, mood and energy, enabling re-engagement with life. The personally tailored nature of the practice and perceived benefits were key motivational factors. Particular value was placed on the therapeutic function of the consultation and provision of tools to manage stress and build resilience.
CONCLUSION


This yoga therapy intervention was positively received by patients with RA, with high levels of adherence to both the treatments and tailored home practice. The findings suggest that yoga therapy has potential as an adjunct therapy to improve RA symptoms, increase self-care behaviours and manage stress and negative affect such as anxiety. A larger multi-centre study is therefore warranted.",2020,"There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05).","['Ten patients took part in a 16 week yoga therapy intervention in a hospital setting, consisting of 10 one-to-one consultations with a yoga therapist followed by two group review sessions', 'rheumatoid arthritis']",['individualised yoga therapy intervention'],"['measures of depression, anxiety, pain, quality of life and general health', 'RA symptoms, increase self-care behaviours', 'Changes in health (EQ-5D, HADS', 'improved sleep, mood and energy, enabling re-engagement with life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",10.0,0.0399396,"There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05).","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cartwright', 'Affiliation': 'University of Westminster, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Cahill', 'Affiliation': 'University of Westminster, London, UK.'}, {'ForeName': 'Vidhi', 'Initials': 'V', 'LastName': 'Sadana', 'Affiliation': 'Rheumatology Unit, Central Middlesex Hospital, London, UK. Electronic address: Vidhi.sohdi@nhs.net.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102339']
2014,32444038,The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Patients with cancer experience many side effects due to its nature and usual treatments. Sleep disorders and anorexia are the most commonly reported symptoms in cancer patients undergoing chemotherapy. The present study aimed to investigate the effect of Benson's Relaxation Response (BRR) on sleep quality and anorexia in cancer patients undergoing chemotherapy.
METHODOLOGY AND PARTICIPANTS


In the present clinical trial, a total of 84 patients were enrolled and randomly divided into two groups of experimental and control. Benson's relaxation response was administered to the experimental group twice a day over 5 consecutive days. Data was collected using St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS).
RESULTS


The results of our study showed a significant improvement in the sleep quality in the experimental group at 24 (p = 0.02) and 48 (p = 0.001) hours after the intervention compared to the control group. Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group. No side effects were reported during the study and follow-up period.
CONCLUSION


Benson's relaxation response as a complementary method may improve sleep quality and anorexia in cancer patients undergoing chemotherapy. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.",2020,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"['84 patients', 'Patients with cancer experience', 'cancer patients undergoing chemotherapy']","[""Benson's Relaxation Response (BRR"", ""Benson's relaxation response""]","['sleep quality and anorexia', 'Sleep disorders and anorexia', 'anorexia', ""St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS"", 'relaxation response (BRR', 'sleep quality', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.027634,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: F_davodabady@arakmu.ac.ir.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Farahani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: z.f.h.nursing@gmail.com.'}, {'ForeName': 'Ali Khanmohamadi', 'Initials': 'AK', 'LastName': 'Hezave', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: alikhan.nurse@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: f.rafiei87@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102344']
2015,32444040,"Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.","INTRODUCTION


Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu.
METHODS


358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day -1 ) or Aq +  (3056 mg day -1 ) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded.
RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq +  improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq +  improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq +  reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq +  was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq +  should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.",2020,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","['participant (n = 30', '358 participants were screened', 'symptomatic (sKOA', 'mild-knee joint osteoarthritis']","['Glucosamine', 'sKOA', 'Mineral rich algae with pine bark', 'Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ', 'Glucosamine (Glu', 'Glu group (2000 mg day -1 ) or Aq ']","['pain, physical function and analgesic use', 'Knee Injury and Osteoarthritis Outcome Score', 'analgesia', 'pain, symptoms and improve physical function', 'pain', 'subjective pain and symptoms', 'TuG', 'pain, KOOS subscales, physical function and analgesia use in mild-sKOA']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0330186', 'cui_str': 'Pinus'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",30.0,0.219278,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Heffernan', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK. Electronic address: s.m.heffernan@swansea.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland; Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eustace', 'Affiliation': 'Cappagh National Orthopaedic Hospital, Dublin, Ireland.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'FitzPatrick', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Vito', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102349']
2016,32444433,"Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).","INTRODUCTION


Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.
METHODS AND ANALYSIS


Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.
ETHICS AND DISSEMINATION


NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.
TRIAL REGISTRATION NUMBER


ISRCTN17825590.",2020,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","['56 participants', 'Subacromial spacer for Tears Affecting Rotator cuff Tendons', 'Tears Affecting Rotator cuff Tendons', '221 participants', 'people with a symptomatic irreparable rotator cuff tear', 'individuals undergoing arthroscopic debridement for irreparable rotator cuff tears']","['subacromial balloon spacer', 'arthroscopic debridement with the InSpace balloon (Stryker, USA', 'deltoid-active MRI scans', 'arthroscopic debridement alone', 'Subacromial spacer']",['Oxford Shoulder Score'],"[{'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",221.0,0.251892,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK A.Metcalfe@warwick.ac.uk.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Gemperle Mannion', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Patient Representative, Durham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Drew', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036829']
2017,32444517,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Evidence-based Medicine Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0435444,,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Mathew', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India. dr.joseph.l.mathew@gmail.com.'}]",Indian pediatrics,[]
2018,32444518,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Pediatrician's Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0246971,,"[{'ForeName': 'Manoja Kumar', 'Initials': 'MK', 'LastName': 'Das', 'Affiliation': 'The INCLEN Trust International, New Delhi, India. manoj@inclentrust.org.'}]",Indian pediatrics,[]
2019,32444519,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Nutritionist's Viewpoint.,,2020,,['Childhood Nutritional Status'],['Community-based Microfinance Scheme'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0243304,,"[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, LHMC and KSCH, New Delhi, India. pkpaed@gmail.com.'}]",Indian pediatrics,[]
2020,32445690,"Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial.","BACKGROUND


Several small studies suggest that the adjunctive use of anti-inflammatory agents might improve depressive symptoms in bipolar disorder. However, there are few well designed, appropriately powered clinical trials assessing the efficacy of these novel treatment strategies. We aimed to assess the efficacy of adjunctive minocycline or celecoxib in this setting.
METHODS


This double-blind, 12-week, randomised, placebo-controlled trial was done in four outpatient psychiatric clinics in Pakistan. Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode. In a 2 × 2 factorial design, participants were randomly assigned (1:1:1:1) to receive either active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib. The primary outcome was the mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17), assessed in all randomised participants (missing data were imputed and assumed to be missing at random). The trial was registered with ClinicalTrials.gov, NCT02703363.
FINDINGS


266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019, were randomly assigned to receive minocycline plus celecoxib (n=68), minocycline plus placebo (n=66), celecoxib plus placebo (n=66), or placebo plus placebo (n=66). From baseline to week 12, depressive symptoms as per HAMD-17 reduced in all four groups (from 24·5-25·2 to 11·3-12·8), but these reductions did not differ significantly between the groups. In terms of main effects, reductions in HAMD-17 did not differ for patients treated with minocycline (mean adjusted difference vs non-minocycline 1·48 [95% CI -0·41 to 3·36]; p=0·123) or for celecoxib (mean adjusted difference vs non-celecoxib -0·74 [-2·61 to 1·14]; p=0·443). Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
INTERPRETATION


We found no evidence that minocycline or celecoxib was superior to placebo for the treatment of bipolar depression. This large trial casts doubt on the potential therapeutic benefits of adjunctive anti-inflammatory drugs for the acute management of bipolar depression.
FUNDING


Stanley Medical Research Institute.",2020,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","['266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019', 'four outpatient psychiatric clinics in Pakistan', 'bipolar depression', 'Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode']","['Minocycline and celecoxib', 'active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib', 'adjunctive minocycline or celecoxib', 'minocycline plus placebo', 'celecoxib plus placebo', 'minocycline', 'placebo plus placebo', 'celecoxib', 'minocycline plus celecoxib', 'placebo']","['HAMD-17', 'depressive symptoms as per HAMD-17', 'mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17', 'Rates of serious adverse effects', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.814161,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","[{'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: ishrat.husain@camh.ca.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Pakistan Institute of Learning and Living, Karachi, Pakistan; Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan; Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Learning and Living, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Moin A', 'Initials': 'MA', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, Pakistan.'}, {'ForeName': 'Haider A', 'Initials': 'HA', 'LastName': 'Naqvi', 'Affiliation': 'Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fareed A', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, Pakistan.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Meyer', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30138-3']
2021,32445735,"Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.
METHODS


This open-label, parallel-group, randomised controlled trial (DIADEM-I), done in primary care and community settings in Qatar, compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region. Participants were randomly allocated (1:1) either to the intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service. The intensive lifestyle intervention comprised a total diet replacement phase, in which participants were given formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support. Participants in the control group received usual diabetes care, which was based on clinical guidelines. The primary outcome was weight loss at 12 months after receiving the assigned intervention. Our analysis was based on the intention-to-treat principle. Key secondary outcomes included diabetes control and remission. The trial was registered with the ISRCTN registry, ISRCTN20754766, and ClinicalTrials.gov, NCT03225339.
FINDINGS


Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study. 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population. Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11·98 kg (95% CI 9·72 to 14·23) compared with 3·98 kg (2·78 to 5·18) in the control group (adjusted mean difference -6·08 kg [95% CI -8·37 to -3·79], p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12·03 [95% CI 5·17 to 28·03], p<0·0001). 33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12·07 [3·43 to 42·45], p<0·0001). Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia).
INTERPRETATION


Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.
FUNDING


Qatar National Research Fund.",2020,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"['147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population', 'Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study', '12·03', 'young individuals with early diabetes', 'individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region', 'early type 2 diabetes (DIADEM-I']","['intensive lifestyle intervention', 'usual diabetes care', 'intensive lifestyle intervention with usual medical care', 'intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service', 'formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support']","['weight loss and glycaemic outcomes', 'diabetes control and remission', 'unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia', 'weight loss', 'diabetes remission', 'normoglycaemia', 'weight loss and improved glycaemia', 'bodyweight and glycaemia', 'Diabetes remission', 'mean bodyweight']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0149881', 'cui_str': 'Orchitis and epididymitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",158.0,0.120849,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"[{'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Electronic address: staheri@me.com.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Chagoury', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Elhadad', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Salma Hayder', 'Initials': 'SH', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'El Khatib', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Rasha Abou', 'Initials': 'RA', 'LastName': 'Amona', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'El Nahas', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Suleiman', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alnaama', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Hamaq', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Charlson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Wells', 'Affiliation': 'University Department of Statistics and Data Science, Cornell University, Ithaca, New York, NY, USA.'}, {'ForeName': 'Samya', 'Initials': 'S', 'LastName': 'Al-Abdulla', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdul Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30117-0']
2022,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.
METHODS


We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.
FINDINGS


Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.
INTERPRETATION


Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.
FUNDING


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
2023,32449414,Eye Care Utilization in A Community-oriented Mobile Screening Programme for Improving Eye Health in Iran: A Cluster Randomized Trial.,"PURPOSE


To evaluate the effect of a mobile-based screening programme on eye care utilization in Iran.
METHOD


In this cluster randomized community trial, a representative sample of residents aged≥50 years from urban and rural areas in four districts in Tehran province were enrolled. The clusters were randomly assigned to one of the three parallel arms; the mHealth arm with digital data collection, vision screening test and retina evaluation using an integrated mobile application, the conventional arm with manual data collection and screening tests using Snellen chart and Fundus photography at the local primary healthcare facility, and the control arm with manual data collection without screening tests. The main outcome measure was eye care utilization which was defined as at least one visit to an optometrist or ophthalmologist.
RESULTS


Of 3312 eligible individuals, 2520 (76.1%) participated. In the first 3 months after the screening programme, eye care utilization was higher among those who were referred by the mHealth method (35.6% 95%CI: 31.1-40.4%) compared to those referred by the conventional method (32.7%, 95%CI: 27.5-38.2%) and to those observed in the control arm (4.5%, 95%CI: 3.2-6.0). Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
CONCLUSION AND RELEVANCE


The mobile-based screening programme can significantly improve eye care utilization at the community level.",2020,"Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
","['Iran', 'Of 3312 eligible individuals, 2520 (76.1%) participated', 'representative sample of residents aged≥50\xa0years from urban and rural areas in four districts in Tehran province were enrolled']","['mHealth arm with digital data collection, vision screening test and retina evaluation using an integrated mobile application, the conventional arm with manual data collection and screening tests using Snellen chart and Fundus photography at the local primary healthcare facility, and the control arm with manual data collection without screening tests', 'mobile-based screening programme']","['Eye care utilization', 'eye care utilization', 'eye care utilization which was defined as at least one visit to an optometrist or ophthalmologist']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517667', 'cui_str': '2520'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0042792', 'cui_str': 'Vision screening'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0029146', 'cui_str': 'Optometrist'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}]",3312.0,0.0910638,"Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Katibeh', 'Affiliation': 'Centre for Global Health, Department of Public Health, Aarhus University , Aarhus, Denmark.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Sabbaghi', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Masomeh', 'Initials': 'M', 'LastName': 'Kalantarion', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Mousavi', 'Affiliation': 'Department of Prevention, Janbazan Medical and Engineering Research Centre , Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Beiranvand', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Ahmadieh', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'Centre for Global Health, Department of Public Health, Aarhus University , Aarhus, Denmark.'}]",Ophthalmic epidemiology,['10.1080/09286586.2020.1768552']
2024,32449418,The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris; a randomized controlled clinical trial.,"Background and Objectives:  Lichen planopilaris (LPP) is one of the important causes of cicatricial alopecia. We aimed to evaluate the efficacy and safety of low-dose naltrexone (LDN) in the setting of a clinical trial in patients with LPP. Methods:  We included patients with LPP between 2018 and 2020. Patients were allocated to two groups. The first group received topical clobetasol plus oral low dose naltrexone (3mg) while the second received topical clobetasol plus placebo. The assessment was made for the disease severity by lichen planopilaris activity index (LPPAI) instrument and the safety of the drug in 2-month intervals up to 6 months. To compare both groups, we used the ANOVA test for repeated measures. Clinical trials registry code: IRCT20180809040747N1. Results:  Thirty-four patients were analyzed in intention-to-treat fashion. There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813). The side effects attributable to the low dose naltrexone was not statistically different between studied groups. Conclusion:  Low dose naltrexone (3mg) failed to improve the severity of the LPP more than what is achievable with topical clobetasol.",2020,There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813).,"['patients with lichen planopilaris', 'patients with LPP', 'patients with LPP between 2018 and 2020']","['naltrexone', 'topical clobetasol plus placebo', 'Lichen planopilaris (LPP', 'low-dose naltrexone (LDN', 'topical clobetasol plus oral low dose naltrexone', 'oral low dose naltrexone', 'placebo']","['efficacy and safety', 'LPPAI scores', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",34.0,0.0910378,There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813).,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Lajevardi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Salarvand', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghiasi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Taraz', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1774488']
2025,32449452,A Randomized Controlled Trial of a Motivational Interviewing Intervention to Improve Whole-Person Lifestyle.,"The purpose of this randomized controlled trial was to examine the effects of a motivational interviewing intervention to improve whole-person lifestyle and reduce cardiovascular disease risk profile. A sample of 111 adults with type 2 diabetes and/or hypertension was recruited from a primary care physician practice. The intervention was facilitated by a program specialist trained in motivational interviewing. Outcomes included body mass index, cholesterol, hemoglobin A1c, blood pressure, waist circumference, wellness scores, and substance use. Differences in the changes in body mass index and waist circumference existed between the intervention and control groups after 6 months. In the intervention group, the proportion of high wellness scores increased after the program. A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness. Efforts to improve the health of these patients may incorporate motivational interviewing to guide goal setting and address mental and spiritual health in addition to physical health.",2020,"A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness.","['111 adults with type 2 diabetes and/or hypertension was recruited from a primary care physician practice', 'patients with metabolic syndrome']","['motivational interviewing intervention', 'Motivational Interviewing Intervention', 'program specialist trained in motivational interviewing']","['cardiovascular disease risk profile', 'body mass index, cholesterol, hemoglobin A1c, blood pressure, waist circumference, wellness scores, and substance use', 'proportion of high wellness scores', 'body mass index and waist circumference']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205250', 'cui_str': 'High'}]",111.0,0.0298626,"A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness.","[{'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Sawyer', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jennelle', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pepe', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Patricia Stearnes', 'Initials': 'PS', 'LastName': 'Robinson', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}]",Journal of primary care & community health,['10.1177/2150132720922714']
2026,32449458,Priming exercise increases Wingate cycling peak power output.,"PURPOSE


The aim of the present study was to investigate the effect of priming exercise on Wingate performance and fatigue.
METHODS


Twelve recreationally active young male volunteers participated in the study (age: 25 ± 5 years; weight: 75.0 ± 7.5 kg; height: 177 ± 6 cm; BMI: 24.0 ± 1.7). During a first visit, participants performed a typical [Formula: see text] test and a supramaximal assessment of [Formula: see text] on a cycle ergometer, while during the next three visits, the participants performed in a random order a Wingate test (i) with no priming exercise, (ii) after priming exercise followed by a 15-min recovery (Priming15) and (iii) after priming exercise followed by a 30-min recovery (Priming30). Priming exercise lasted 6 min, at work rate corresponding to the gas exchange threshold (GET) plus 70% of the difference between the GET and [Formula: see text].
RESULTS


The Priming 30 condition exhibited greater peak power output (595 ± 84 W) compared to the control (567 ± 85 W) and the Priming15 condition (569 ± 95 W) ( P  < .05). Regarding fatigue index, a tendency towards increased resistance to fatigue was observed in the Priming30 condition compared to the control and the Priming15 conditions ( P  = .072). Pre-Wingate lactate levels were found to be significantly different between the Priming15 (7.18 ± 3.09 mmol/L) and the Priming30 (4.87 ± 2.11 mmol/L) conditions ( P  < .05).
CONCLUSIONS


Priming exercise of high intensity followed by a prolonged recovery leads to increased peak power in a subsequent Wingate test. Moreover, our data are consistent with the idea that a priming exercise-induced modest increase in blood lactate concentration at the onset of the following criterion bout is a key factor of performance.",2020,"Regarding fatigue index, a tendency towards increased resistance to fatigue was observed in the Priming30 condition compared to the control and the Priming15 conditions ( P  = .072).",['Twelve recreationally active young male volunteers participated in the study (age: 25\u2009±\u20095 years; weight: 75.0\u2009±\u20097.5\u2005kg; height: 177\u2009±\u20096\u2005cm; BMI: 24.0\u2009±\u20091.7'],"['supramaximal assessment of [Formula: see text] on a cycle ergometer, while during the next three visits, the participants performed in a random order a Wingate test (i) with no priming exercise, (ii) after priming exercise followed by a 15-min recovery (Priming15) and (iii) after priming exercise', 'Priming exercise', 'priming exercise']","['resistance to fatigue', 'Wingate performance and fatigue', 'blood lactate concentration', 'Wingate lactate levels', 'peak power output']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.0457166,"Regarding fatigue index, a tendency towards increased resistance to fatigue was observed in the Priming30 condition compared to the control and the Priming15 conditions ( P  = .072).","[{'ForeName': 'Charalabos K', 'Initials': 'CK', 'LastName': 'Ktenidis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikos V', 'Initials': 'NV', 'LastName': 'Margaritelis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Evgenia D', 'Initials': 'ED', 'LastName': 'Cherouveim', 'Affiliation': 'Sports Excellence, 1st Orthopaedic Dept, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitris C', 'Initials': 'DC', 'LastName': 'Stergiopoulos', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Vassiliki J', 'Initials': 'VJ', 'LastName': 'Malliou', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikos D', 'Initials': 'ND', 'LastName': 'Geladas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michalis G', 'Initials': 'MG', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Paschalis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}]",European journal of sport science,['10.1080/17461391.2020.1765026']
2027,32446323,Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials.,"BACKGROUND


Three drug classes (mineralocorticoid receptor antagonists [MRAs], angiotensin receptor-neprilysin inhibitors [ARNIs], and sodium/glucose cotransporter 2 [SGLT2] inhibitors) reduce mortality in patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers. Each class was previously studied with different background therapies and the expected treatment benefits with their combined use are not known. Here, we used data from three previously reported randomised controlled trials to estimate lifetime gains in event-free survival and overall survival with comprehensive therapy versus conventional therapy in patients with chronic HFrEF.
METHODS


In this cross-trial analysis, we estimated treatment effects of comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker) in patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744). Our primary endpoint was a composite of cardiovascular death or first hospital admission for heart failure; we also assessed these endpoints individually and assessed all-cause mortality. Assuming these relative treatment effects are consistent over time, we then projected incremental long-term gains in event-free survival and overall survival with comprehensive disease-modifying therapy in the control group of the EMPHASIS-HF trial (ACE inhibitor or ARB and β blocker).
FINDINGS


The hazard ratio (HR) for the imputed aggregate treatment effects of comprehensive disease-modifying therapy versus conventional therapy on the primary endpoint of cardiovascular death or hospital admission for heart failure was 0·38 (95% CI 0·30-0·47). HRs were also favourable for cardiovascular death alone (HR 0·50 [95% CI 0·37-0·67]), hospital admission for heart failure alone (0·32 [0·24-0·43]), and all-cause mortality (0·53 [0·40-0·70]). Treatment with comprehensive disease-modifying pharmacological therapy was estimated to afford 2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy.
INTERPRETATION


Among patients with HFrEF, the anticipated aggregate treatment effects of early comprehensive disease-modifying pharmacological therapy are substantial and support the combination use of an ARNI, β blocker, MRA, and SGLT2 inhibitor as a new therapeutic standard.
FUNDING


None.",2020,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"['patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of', '2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction', 'patients with chronic HFrEF.\nMETHODS', 'patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744']","['comprehensive disease-modifying pharmacological therapy', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers', 'comprehensive disease-modifying pharmacological therapies', 'comprehensive therapy versus conventional therapy', 'comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker']","['cardiovascular death or hospital admission for heart failure', 'hospital admission for heart failure alone (0·32', 'hazard ratio (HR', 'composite of cardiovascular death or first hospital admission for heart failure', 'cardiovascular death alone (HR 0·50 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.181843,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Pedro Ferreira', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France; Department of Physiology and Cardiothoracic Surgery, University of Porto, Porto, Portugal.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA; Imperial College, London, UK.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine, University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: ssolomon@bwh.harvard.edu.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)30748-0']
2028,32446470,"Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.","OBJECTIVE


To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.
STUDY DESIGN


Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.
RESULTS


In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.
CONCLUSIONS


Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03294473 and NCT03246100.",2020,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","['Influenza Vaccinations', '61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices', 'October 2017 to April 1, 2018, in New York State and Colorado']","['centralized reminder/recall (autodialer, text, mailed reminders', 'centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control']","['postintervention influenza vaccination rates', 'receipt of ≥1 influenza vaccine']","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",61931.0,0.279722,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA. Electronic address: pszilagyi@mednet.ucla.edu.""}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, CO.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.020']
2029,32446591,Comparison of the postoperative and follow-up accuracy of articulator model surgery and virtual surgical planning in skeletal class III patients.,"The aim of this study was to evaluate the postoperative and follow-up accuracy of using an intermediate occlusal splint between articulator model surgery (AMS) and virtual surgical planning (VSP) in double-jaw operations. Thirty skeletal class III patients were randomly allocated to have AMS or VSP. In the AMS group surgical planning was done through conventional articulator model surgery, and an intermediate occlusal splint made of acrylic resin was used. In the VSP group the surgical simulation was done virtually, and the same intermediate splint was used in the software and then fabricated using rapid prototyping technology. Preoperatively, one week postoperatively, and 1∼2-years later we obtained follow-up cone-beam computed tomographic (CT) images of each patient. Absolute linear differences between planned and actual outcomes, as well as planned and follow-up outcomes, were evaluated. There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse. Planning transfer by intermediate splint might therefore be the dominant factor in the final inaccuracies. The potentially greater accuracy of VSP may be realised with the help of new positioning devices instead of an intermediate splint.",2020,"There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse.","['Thirty skeletal class III patients', 'skeletal class III patients']","['VSP', 'articulator model surgery and virtual surgical planning', 'AMS or VSP', 'intermediate occlusal splint between articulator model surgery (AMS) and virtual surgical planning (VSP']","['postoperative accuracy', 'rate of skeletal relapse']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003911', 'cui_str': 'Articulators'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",30.0,0.0157353,"There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Orthodontics, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China; State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': ""Department of Orthodontics, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, School of Medicine, No. 639 Zhizaoju Road, Shanghai, PR China.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China. Electronic address: lijingtao86@163.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Orthodontics, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China. Electronic address: wenlilai@scu.edu.cn.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.04.032']
2030,32446674,Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey.,"STUDY OBJECTIVE


It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
METHODS


A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ 2 , and Fisher's exact tests were conducted.
RESULTS


Of 317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
CONCLUSION


This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.",2020,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","['participants at all sites in a large, multicenter exception from informed consent trial', 'Twenty-seven percent disagreed with enrollment in the study without prospective consent', '317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed', 'Black participants', 'pediatric and adult patients']",['benzodiazepine-refractory status epilepticus'],"['attitudes toward trial enrollment, exception from informed consent, and community consultation']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",317.0,0.0303521,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","[{'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Scicluna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI. Electronic address: vmah@med.umich.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Biros', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Deneil K', 'Initials': 'DK', 'LastName': 'Harney', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Jones', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Mitchell', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Pentz', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'Speight', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Neal W', 'Initials': 'NW', 'LastName': 'Dickert', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Emory University Rollins School of Public Health, Atlanta, GA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.03.017']
2031,32446787,"Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial.","BACKGROUND & AIMS


In preterm infants, natural variation of breast milk composition makes it difficult to achieve recommended macronutrient intakes with standard fortification. Evidence suggests that nutritional deficiency induces poor postnatal growth. This study investigates impacts of target fortification on preterm growth and metabolism by adjusting breast milk macronutrients.
METHODS


This study was conducted as a single-centre, double-blind, randomized controlled trial for infants <30 gestational weeks. The control group received standard fortification and the intervention group received standard plus target fortification adding modular protein, lipids, and carbohydrates. Breast milk content was measured 3x/week using a validated near-infrared bedside spectrometer (NIRS). Modulars were added to achieve recommended values. To assess total nutrient intake, all 2810 native breast milk samples were analyzed - protein and fat using bedside-NIRS, lactose using tandem mass spectrometry (UPLC-MS/MS). Body composition was measured using air displacement plethysmography. Primary outcome was weight gain during the first 21 days of intervention.
RESULTS


Baseline characteristics, morbidities, and total fluid intake were not different between groups (intervention n = 52, control n = 51). The intervention group infants had higher macronutrient intakes, weight gain (21.2 ± 2.5 vs 19.3 ± 2.4 g/kg/d, mean difference: 1.9 g/kg/d, 95% CI: 0.9 - 2.9), and body weight. Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass. Also, feeding intolerance was less frequent, blood urea was higher, and triglycerides were lower.
CONCLUSIONS


This study provides evidence that target fortification of breast milk with low macronutrient content enhances the quality of nutrition and growth and is feasible in clinical routine.",2020,"Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass.","['21.2\xa0±\xa02.5 vs 19.3\xa0±\xa02.4\xa0g/kg/d, mean difference', '2810 native breast milk samples', 'infants <30 gestational weeks', 'preterm infants']","['standard fortification and the intervention group received standard plus target fortification adding modular protein, lipids, and carbohydrates']","['blood urea', 'Body composition', 'higher macronutrient intakes, weight gain', 'body weight', 'weight gain', 'morbidities, and total fluid intake', 'preterm growth and metabolism']","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.415734,"Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Rochow', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, Paracelsus Medical School, General Hospital of Nuremberg, Nuremberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Fusch', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Anaam', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Akshdeep', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hon Yiu', 'Initials': 'HY', 'LastName': 'So', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Iskander', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Chessell', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salhab', 'Initials': 'S', 'LastName': 'El Helou', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Fusch', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, Paracelsus Medical School, General Hospital of Nuremberg, Nuremberg, Germany. Electronic address: christoph.fusch@klinikum-nuernberg.de.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.04.031']
2032,32446832,"A Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Plaque Psoriasis: Secondary Efficacy and Patient-Reported Outcomes.","BACKGROUND


Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for treatment of psoriasis and atopic dermatitis.
METHODS


In a phase IIb, double-blind, vehicle-controlled study, adults with plaque psoriasis were randomized to tapinarof cream 0.5% or 1% once (QD) or twice daily (BID) or vehicle QD or BID for 12 weeks with 4-week follow-up. Efficacy outcomes included Physician Global Assessment (PGA) scores, change in PGA and total target lesion grading scores, and proportion of subjects achieving ≥50%, ≥75%, and ≥90% reductions in Psoriasis Area and Severity Index scores from baseline (PASI50, 75, and 90).
RESULTS


At week 12, improvements were observed in all tapinarof groups versus vehicle in PGA response, change in PGA and total target lesion grading scores, PASI50 (71-92% versus 10-32%), PASI75 (46-65% versus 5-16%), and PASI90 (18-40% versus 0%); all differences were statistically significant with tapinarof 1%QD. Tapinarof responses were apparent from week 2, with significant efficacy at week 8 maintained through week 16. Most adverse events were mild or moderate.
LIMITATIONS


Analyses reported require confirmation in larger prospective studies.
CONCLUSIONS


Tapinarof may represent an important advance in the development of topical medicines for treatment of psoriasis.",2020,"At week 12, improvements were observed in all tapinarof groups versus vehicle in PGA response, change in PGA and total target lesion grading scores, PASI50 (71-92% versus 10-32%), PASI75","['adults with plaque psoriasis', 'Plaque Psoriasis']","['Tapinarof cream', 'Tapinarof Cream', 'tapinarof cream 0.5% or 1% once (QD) or twice daily (BID) or vehicle QD', 'PASI75']","['Psoriasis Area and Severity Index scores', 'Tapinarof responses', 'Physician Global Assessment (PGA) scores, change in PGA and total target lesion grading scores, and proportion of subjects achieving ≥50', 'PGA response, change in PGA and total target lesion grading scores, PASI50']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C4541381', 'cui_str': 'tapinarof'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C3853087', 'cui_str': 'One to two times'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4541381', 'cui_str': 'tapinarof'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}]",,0.0831723,"At week 12, improvements were observed in all tapinarof groups versus vehicle in PGA response, change in PGA and total target lesion grading scores, PASI50 (71-92% versus 10-32%), PASI75","[{'ForeName': 'Linda Stein', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA. Electronic address: LSTEIN1@hfhs.org.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Therapeutics Clinical Research, San Diego, CA, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Tallman', 'Affiliation': 'Dermavant Sciences, Inc., New York, NY, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rubenstein', 'Affiliation': 'Dermavant Sciences, Inc., Durham, NC, USA.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.181']
2033,32446842,Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.,"PURPOSE


To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.
DESIGN


Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).
PARTICIPANTS


Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.
METHODS


A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT.
MAIN OUTCOME MEASURES


We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC.
RESULTS


A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001).
CONCLUSIONS


Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.",2020,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","['22 patients undergoing', 'A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC', 'eyes treated with cooling anesthesia', 'Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included']","['standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia', 'Ultra-Rapid Cooling Anesthesia', 'bilateral IVT', 'cooling anesthesia']","['Mild, transient adverse events', 'Mean VAS pain scores', 'Mean±SEM pain scores', 'toxicity', 'mean±standard error of the mean (SEM) VAS pain scores', 'Total mean±SEM procedure time', 'Subjective pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2237660', 'cui_str': 'Wet Macular Degeneration'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",22.0,0.0922038,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","[{'ForeName': 'Cagri G', 'Initials': 'CG', 'LastName': 'Besirli', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. Electronic address: cbesirli@med.umich.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University School of Medical, Palo Alto, California; iRenix Medical, Inc., Palo Alto, California.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Zacks', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Pipe', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan; Department of Electrical Engineering and Computer Science, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Shah', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.001']
2034,32446864,"Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial ""NIMBUS"".","BACKGROUND


Intravesical instillation of bacillus Calmette-Guérin (BCG) is an accepted strategy to prevent recurrence of non-muscle-invasive bladder cancer (NMIBC) but associated with significant toxicity.
OBJECTIVE


NIMBUS assessed whether a reduced number of standard-dose BCG instillations are noninferior to the standard number and dose in patients with high-grade NMIBC.
DESIGN, SETTING, AND PARTICIPANTS


A total of 345 patients from 51 sites were randomised between December 2013 and July 2019. We report results after a data review and safety analysis by the Independent Data Monitoring Committee based on the cut-off date of July 1, 2019.
INTERVENTION


The standard BCG schedule was 6 wk of induction followed by 3 wk of maintenance at 3, 6, and 12 mo (15 instillations). The reduced frequency BCG schedule was induction at wks 1, 2, and 6 followed by 2 wk (wks 1 and 3) of maintenance at 3, 6, and 12 mo (nine instillations).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was time to first recurrence. Secondary endpoints included progression to ≥ T2 and toxicity.
RESULTS AND LIMITATIONS


In total, 170 patients were randomised to reduced frequency and 175 to standard BCG. Prognostic factors at initial resection were as follows: Ta/T1: 46/54%; primary/recurrent: 92/8%; single/multiple: 57/43%; and concomitant carcinoma in situ: 27%. After 12 mo of median follow-up, the intention-to-treat analysis showed a safety-relevant difference in recurrences between treatment arms: 46/170 (reduced frequency) versus 21/175 patients (standard). Additional safety analyses showed a hazard ratio of 0.40 with the upper part of the one-sided 97.5% confidence interval of 0.68, meeting a predefined stopping criterion for inferiority.
CONCLUSIONS


The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence. Further recruitment of patients was stopped immediately to avoid harm in the reduced frequency BCG arm.
PATIENT SUMMARY


After surgical removal of the tumour, patients with high-grade non-muscle-invasive bladder cancer are treated with bacillus Calmette-Guérin to prevent recurrence and progression. This is associated with significant side effects. We report the results of a clinical trial showing a reduction in the number of instillations (from 15 to nine in total) being inferior to the standard protocol. From today's perspective, complete tumour resection and a standard number of instillations remain the standard of care.",2020,The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence.,"['170 patients were randomised to reduced frequency and 175 to standard BCG', '345 patients from 51 sites were randomised between December 2013 and July 2019', 'patients with high-grade NMIBC', 'patients with high-grade non-muscle-invasive bladder cancer']","['bacillus Calmette-Guérin (BCG', 'BCG Instillations']","['progression to\u2009≥\u2009T2 and toxicity', 'safety-relevant difference in recurrences', 'time to first recurrence']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",170.0,0.173047,The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence.,"[{'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany. Electronic address: marc-oliver.grimm@med.uni-jena.de.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Urology, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Colombel', 'Affiliation': 'Department of Urology, Hospital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Muilwijk', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martínez-Piñeiro', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Marko M', 'Initials': 'MM', 'LastName': 'Babjuk', 'Affiliation': 'Department of Urology, Hospital Motol, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Levent N', 'Initials': 'LN', 'LastName': 'Türkeri', 'Affiliation': 'Department of Urology, Acıbadem University, Istanbul, Turkey.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Palou', 'Affiliation': 'Urology Department, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'London, UK.'}, {'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Bjartell', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands; Skåne University Hospital, Lund University, Sweden.'}, {'ForeName': 'Christien', 'Initials': 'C', 'LastName': 'Caris', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': 'Raymond G', 'Initials': 'RG', 'LastName': 'Schipper', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': 'Wim P J', 'Initials': 'WPJ', 'LastName': 'Witjes', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.04.066']
2035,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND


Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown.
METHODS


In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36).
RESULTS


A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
CONCLUSIONS


In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883']
2036,32447224,Shorter sleep duration is associated with lower GABA levels in the anterior cingulate cortex.,"BACKGROUND


Alterations in the levels of gamma-aminobutyric acid (GABA) and glutamate + glutamine (Glx), which are major inhibitory and excitatory neurotransmitters, respectively, are frequently associated with insomnia. Previous reports also suggested the involvement of the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration. In the current study, we investigated whether the GABA and Glx levels were altered in the ACC/mPFC in subclinical insomnia while focusing on the sleep duration.
METHODS


We examined levels of GABA and Glx in the ACC/mPFC of the brain with magnetic resonance spectroscopy in 166 individuals with subjective sleep complaints but without a diagnosis of insomnia. Participants were divided into two groups according to sleep duration (≥6 h/night: n = 79 vs. < 6 h/night: n = 74), which was measured using a wrist-worn actigraphy. Working memory function and overall subjective sleep quality were assessed with a computerized neuropsychological test and self-report questionnaire, respectively.
RESULTS


GABA levels in the ACC/mPFC were lower in the shorter sleep duration group relative to the longer sleep duration group (t = -2.21, p = 0.03). Glx levels did not differ between the two groups (t = -0.20, p = 0.84). Lower GABA levels were associated with lower spatial working memory performance in the shorter sleep duration group (β = -0.21, p = 0.03), but not the longer sleep duration group (β = 0.04, p = 0.72).
CONCLUSION


Shorter sleep duration was associated with lower GABA levels in the ACC/mPFC. These findings may provide insight into the underlying mechanisms of impaired working memory function related to insomnia and sleep loss.",2020,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).",['166 individuals with subjective sleep complaints but without a diagnosis of insomnia'],['magnetic resonance spectroscopy'],"['Shorter sleep duration', 'anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration', 'Glx levels', 'mPFC', 'Working memory function and overall subjective sleep quality', 'GABA levels', 'GABA and Glx levels', 'Lower GABA levels', 'spatial working memory performance']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",166.0,0.0321215,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).","[{'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Ilhyang', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; F.M. Kirby Research Center for Functional Brain Imaging, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jinsol', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: jungyoon.kimm@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.018']
2037,32447296,"CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study.","BackgroundConcurrent chemoradiotherapy is the standard of care for locally advanced cervical cancer. Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
PRIMARY OBJECTIVE


The CALLA trial is designed to determine the efficacy and safety of the programmed cell death-ligand 1 blocking antibody, durvalumab, with and following concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in women with locally advanced cervical cancer.
STUDY HYPOTHESIS


Durvalumab concurrent with and following concurrent chemoradiotherapy will improve progression-free survival in patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA cervical cancer compared with concurrent chemoradiotherapy alone.
TRIAL DESIGN


CALLA is a phase III, randomized, multicenter, international, double-blind, placebo-controlled study. Patients will be randomized 1:1 to receive either durvalumab (1500 mg intravenously (IV)) or placebo every 4 weeks for 24 cycles. All patients will receive external beam radiotherapy with cisplatin (40 mg/m 2 ) IV or carboplatin (area under the curve 2) IV once a week for 5 weeks, followed by image-guided brachytherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study will enroll immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage. Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer.
PRIMARY ENDPOINT


The primary endpoint is progression-free survival (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors v1.1, histopathological confirmation of local tumor progression or death).
SAMPLE SIZE


Approximately 714 patients will be randomized 1:1 to receive either durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Patient enrollment is continuing globally with an estimated completion date of April 2024.
TRIAL REGISTRATION


NCT03830866.",2020,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","['Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer', 'naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage', 'locally advanced cervical cancer', 'Approximately 714 patients', 'women with locally advanced cervical cancer', 'patients with International Federation of Gynecology and Obstetrics']","['durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy', 'chemoradiotherapy versus concurrent chemoradiotherapy alone', 'placebo', 'chemoradiotherapy', 'Concurrent chemoradiotherapy', 'durvalumab', 'immunotherapy', 'external beam radiotherapy with cisplatin (40\u2009mg/m 2 ) IV or carboplatin', 'CALLA', 'concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone']","['progression-free survival', 'histopathological confirmation of local tumor progression or death', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0279672', 'cui_str': 'Adenocarcinoma of cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0331463', 'cui_str': 'Calla'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.614757,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'GYN Cancers, Rebecca and John Moores Cancer Center, La Jolla, California, USA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Nunes', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Marcovitz', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Josephs Hospital and Medical Center, Phoenix, Arizona, USA bradley.monk@usoncology.com.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001135']
2038,32447315,"Effect of flavour manipulation on ENDS (JUUL) users' experiences, puffing behaviour and nicotine exposure among US college students.","SIGNIFICANCE


Electronic nicotine delivery system (ENDS) use has continued to increase exponentially among young people in the USA, with unique flavours being one of the most cited reasons for use. Yet, controlled studies examining the effects of restricting flavour are lacking. This study evaluates the impact of ENDS flavour manipulation on user's puffing behaviour, subjective experience, harm perception and nicotine exposure among college-aged ENDS users.
METHODS


JUUL users (n=30, age 18 to 24 years) attended two 60 min  ad libitum  ENDS use sessions (JUUL preferred flavour vs JUUL classic tobacco flavour) in a cross-over design. Puff topography and plasma nicotine concentration were measured, and participants completed subjective experience questionnaires.
RESULTS


Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05). Compared with preferred flavour, participants in the tobacco flavour were less motivated to use it in the future (70.9 vs 19.1 scores, p<0.001), even if it was the only product on the market (75.8 vs 30.7 scores, p<0.001). While nicotine levels significantly increased in both conditions from pre to post session (p values <0.001), no significant differences were observed in nicotine boost levels or on puff topography parameters when comparing both flavour conditions.
CONCLUSIONS


This pilot study provides evidence that ENDS flavours have a substantial effect in enhancing young current ENDS users' experiences, product appeal and motivation to use the product in the future. It highlights that limiting flavours could play a potential role when designing strategic policies to reduce the appeal of ENDS use among young people.",2020,"RESULTS


Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05).","['US college students', 'college-aged ENDS users', 'JUUL users (n=30, age 18 to 24 years']","['flavour manipulation', 'ENDS flavour manipulation', 'Electronic nicotine delivery system (ENDS', 'attended two 60\u2009min  ad libitum  ENDS use sessions (JUUL preferred flavour vs JUUL classic tobacco flavour', 'ENDS flavours']","['Puff topography and plasma nicotine concentration', 'nicotine boost levels', 'satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0222113,"RESULTS


Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05).","[{'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Vargas', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ebrahimi Kalan', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ward-Peterson', 'Affiliation': 'Community Based Research Institute, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Olatokunbo', 'Initials': 'O', 'LastName': 'Osibogun', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Family and Community Medicine, Florida International University College of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Psychology and Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Maziak', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA wmaziak@fiu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055551']
2039,32447339,Tragus Nerve Stimulation Suppresses Post-Infarction Ventricular Arrhythmia by Modulating Autonomic Activity and Heterogeneities of Cardiac Receptor Distribution.,"BACKGROUND Imbalanced cardiac autonomic control and cardiac receptors redistribution contribute to the arrhythmogenic substrate under the myocardial infarction (MI) condition. Stimulating the auricular branch of vagus nerve (AB-VNS) has been proven to reduce post-infarction ventricular arrhythmia (VAs), but its potential mechanisms were largely unknown. This study aimed to investigate whether long-term intermittent low-intensity AB-VNS could produce a protective effect on modulating autonomic activities and abnormal redistribution of autonomic nerve efferent receptors in a MI canine model. MATERIAL AND METHODS Twelve healthy beagle dogs underwent ligation of the left anterior descending coronary artery to establish a MI model and were randomized into 2 groups: an AB-VNS group, (AB-VNS for 4 weeks) and a control group (sham stimulation for 4 weeks). Dynamic electrocardiogram recording, neural recording, catecholamine concentration, and histological studies were conducted subsequently. RESULTS Compared to the control group, the AB-VNS group had significantly suppressed post-infarction VAs, reduced low frequency (LF) power and increased high frequency (HF) power. In the AB-VNS group, with the progression of reduced cardiac sympathetic activities and augmented cardiac parasympathetic activities, the catecholamine concentration in heart tissue declined in the peripheral infarction area and right ventricle (RV); tyrosine hydroxylase (TH)-positive neurons decreased in the inferior cardiac sympathetic nerve, and choline acetyltransferase (ChAT)-positive neurons increased in the cervical vagus nerve. Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS. The mRNA expression of adrenergic and nicotinic receptors (ß₁-AR, ß₃-AR, and CHRNA7) significantly declined in the peri-MI and non-MI area of the AB-VNS group. CONCLUSIONS Chronic intermittent low-intensity AB-VNS effectively suppressed post-infarction VAs by potentially rebalancing extracardiac intrathoracic autonomic activities, reducing excessive cardiac sympathetic denervation, and attenuating the heterogeneities of cardiac efferent nerve receptors distribution.",2020,Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS.,['Twelve healthy beagle dogs underwent'],"['AB-VNS group, (AB-VNS for 4 weeks) and a control group (sham stimulation', 'vagus nerve (AB-VNS', 'ligation of the left anterior descending coronary artery to establish a MI model']","['post-infarction VAs, reduced low frequency (LF) power and increased high frequency (HF) power', 'mRNA expression of adrenergic and nicotinic receptors (ß₁-AR, ß₃-AR, and CHRNA7', 'peripheral infarction area and right ventricle (RV); tyrosine hydroxylase (TH)-positive neurons', 'Expression of TrkA and P75NGFR', 'cardiac sympathetic activities and augmented cardiac parasympathetic activities, the catecholamine concentration in heart tissue']","[{'cui': 'C0324306', 'cui_str': 'Beagle'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic receptor'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0041491', 'cui_str': 'Tyrosine 3-monooxygenase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}]",12.0,0.0164927,Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS.,"[{'ForeName': 'Huaxin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Buajieer-Guli', 'Initials': 'BG', 'LastName': 'Nasi-Er', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Yaodong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Lianwei', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China (mainland).""}, {'ForeName': 'Qina', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'BaoPeng', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922277']
2040,32447370,Impact of meningococcal B (4CMenB) vaccine on pharyngeal Neisseria meningitidis carriage density and persistence in adolescents.,"BACKGROUND


Higher density of Neisseria meningitidis carriage may be associated with transmission of the meningococcus. Our aim was to establish the impact of 4CMenB vaccine on N. meningitidis carriage density.
METHODS


We compared 4CMenB vaccine to control among 913 South Australian students aged approximately 15-18 years in a cluster randomized trial who had N. meningitidis carriage at 12 months. Oropharyngeal swabs were collected at baseline and 12 months later to detect N. meningitidis carriage. Colony forming units per millilitre (CFU/ml) were estimated by generating a standard curve that plotted qPCR cycle threshold values against log-normalized CFU.
RESULTS


Among the 913 students with N. meningitidis carriage at 12 months, there was no difference in mean carriage density between the vaccinated (n=434, 3.80 log CFU/ml [SD 1.29]) and control group (n=479, 3.73 log CFU/ml [SD 1.30]; p=0.51). Higher N. meningitidis carriage density at baseline was associated with an increase in the odds of persistent carriage at 12 months (n=504, odds ratio per 1.0 log CFU/ml increase in density = 1.36 [95% CI, 1.17, 1.58], p<0.001). Students with baseline carriage who were vaccinated had decreased persistent N. meningitidis carriage at 12 months compared to unvaccinated students (82/186 [31%] vs 105/186 [43%], odds ratio 0.60 [95% CI, 0.40, 0.90], p=0.01).
CONCLUSION


4CMenB vaccine did not reduce carriage density of N. meningitidis 12 months post vaccination, despite increased carriage clearance. Higher carriage density is likely to enable transmission through prolonged periods of population exposure.
CLINICAL TRIALS REGISTRATION


Clinicaltrials.gov NCT03089086.",2020,"Higher N. meningitidis carriage density at baseline was associated with an increase in the odds of persistent carriage at 12 months (n=504, odds ratio per 1.0 log CFU/ml increase in density = 1.36 [95% CI, 1.17, 1.58], p<0.001).","['913 students with N', '913 South Australian students aged approximately 15-18 years in a cluster randomized trial who had N. meningitidis carriage at 12 months', 'adolescents']","['meningococcal B (4CMenB) vaccine', '4CMenB vaccine']","['persistent N. meningitidis carriage', 'carriage clearance', 'mean carriage density', 'carriage density', 'meningitidis carriage', 'meningitidis carriage density']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3859491', 'cui_str': 'meningococcal group B vaccine'}, {'cui': 'C3490189', 'cui_str': '4CMenB vaccine'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",913.0,0.380295,"Higher N. meningitidis carriage density at baseline was associated with an increase in the odds of persistent carriage at 12 months (n=504, odds ratio per 1.0 log CFU/ml increase in density = 1.36 [95% CI, 1.17, 1.58], p<0.001).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McMillan', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, SA, Australia.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Walters', 'Affiliation': 'Microbiology and Infectious Diseases Directorate, SA Pathology, Adelaide, SA, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women & Kids, South Australian Health & Medical Research Institute,\xa0Australia.'}, {'ForeName': 'Lex E X', 'Initials': 'LEX', 'LastName': 'Leong', 'Affiliation': 'Microbiology and Infectious Diseases Directorate, SA Pathology, Adelaide, SA, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turra', 'Affiliation': 'Microbiology and Infectious Diseases Directorate, SA Pathology, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lawrence', 'Affiliation': 'Microbiology and Infectious Diseases Directorate, SA Pathology, Adelaide, SA, Australia.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Koehler', 'Affiliation': 'Communicable Disease Control Branch, SA Health, Adelaide, South Australia, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': ""Bristol Children's Vaccine Centre, Schools of Cellular and Molecular Medicine & of Population Health Sciences, University of Bristol, Bristol, England.""}, {'ForeName': 'Ross M', 'Initials': 'RM', 'LastName': 'Andrews', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Marshall', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, SA, Australia.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa610']
2041,32447394,Reducing the initial number of rituximab maintenance-therapy infusions for ANCA-associated vasculitides: randomized-trial post-hoc analysis.,,2020,,[],[],[],[],[],[],,0.042812,,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Dechartres', 'Affiliation': ""Sorbonne Universitù, Institut National de la Santù et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP. Sorbonne Université, Hôpital Pitié Salpêtriére, Département de Santé Publique, Paris.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Faguer', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Huart', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamidou', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bonnotte', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Samson', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Centre de Néphrologie et de Transplantation Rénale, Unité de Néphrologie, APHP, Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Jourde-Chiche', 'Affiliation': 'Aix-Marseille Université, Centre de Néphrologie et de Transplantation Rénale, AP-HM, Hôpital de la Conception, Marseille.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': 'Service de Médecine Interne Hématologie, CH de Dax, Dax.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Hôpital Général Henri-Duffaut, Avignon.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanrotel-Saliou', 'Affiliation': 'Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital la Cavale Blanche, CH Régionale Universitaire Brest, Brest.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Département de Médecine Interne, CH Bretagne Atlantique de Vannes, Vannes.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin-Silva', 'Affiliation': 'Unité de Médecine Interne, CHU de Caen, Caen.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Service de Médecine Interne, CHU de Toulouse, Toulouse.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Matignon', 'Affiliation': 'Service de Néphrologie, APHP, CHU Henri-Mondor, Créteil.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Aumaitre', 'Affiliation': 'Service de Médecine Interne, CHU, Hôpital Gabriel-Montpied, Clermont-Ferrand.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Viallard', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, CHU de Bordeaux, Pessac.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Service de Médecine Interne, Hôpitaux Privés de Metz, Metz.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Meaux-Ruault', 'Affiliation': 'Service de Médecine Interne, CHU Jean-Minjoz, Besançon.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': 'Service de Médecine Interne, CHU de Montpellier, Montpellier.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Service de Rhumatologie, Hôpital de Hautepierre, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa222']
2042,32447409,Modulation of vocal pitch control through high-definition transcranial direct current stimulation of the left ventral motor cortex.,"Neural interactions between sensorimotor integration mechanisms play critical roles in voice motor control. We investigated how high-definition transcranial direct current stimulation (HD-tDCS) of the left ventral motor cortex modulates neural mechanisms of sensorimotor integration during voice motor control. HD-tDCS was performed during speech vowel production in an altered auditory feedback (AAF) paradigm in response to upward and downward pitch-shift stimuli. In one experiment, two groups received either anodal or cathodal 2 milliamp (mA) HD-tDCS to the left ventral motor cortex while a third group received sham (placebo) stimulation. In a second experiment, two groups received either 1 mA or 2 mA cathodal HD-tDCS to the left ventral motor cortex. Results of the first experiment indicated that the magnitude of vocal compensation was significantly reduced following anodal and cathodal HD-tDCS only in responses to downward pitch-shift AAF stimuli, with stronger effects associated with cathodal HD-tDCS. However, no such effect was observed following sham stimulation. Results of the second experiment indicate that there is not a differential effect of modulation from 1 mA versus 2 mA. Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only. These findings suggest that neurostimulation of the left ventral motor cortex modulates sensorimotor mechanisms underlying voice motor control. We speculate that this effect is associated with the increased contribution of feedforward motor mechanisms, leading to reduced compensatory speech responses to AAF.",2020,"Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only.",[],"['1\xa0mA or 2\xa0mA cathodal HD-tDCS', 'vocal pitch control through high-definition transcranial direct current stimulation', 'HD-tDCS', 'high-definition transcranial direct current stimulation (HD-tDCS', 'anodal or cathodal 2 milliamp (mA) HD-tDCS to the left ventral motor cortex while a third group received sham (placebo) stimulation']",['magnitude of vocal compensation'],[],"[{'cui': 'C0450172', 'cui_str': 'mA - milliampere'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0234789', 'cui_str': 'Vocal pitch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}]",,0.0215293,"Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only.","[{'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Bridwell', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hayden', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Fahey', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Dirk-Bart', 'Initials': 'DB', 'LastName': 'den Ouden', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA. denouden@sc.edu.'}]",Experimental brain research,['10.1007/s00221-020-05832-9']
2043,32447474,Hand-foot syndrome and survival in patients with advanced non-small-cell lung cancer receiving anlotinib: a subgroup analysis of data from the ALTER 0303 study.,"BACKGROUND


The ALTER 0303 study showed that anlotinib can significantly improve overall survival (OS) compared with the placebo in advanced non-small-cell lung cancer (NSCLC). Hand-foot syndrome (HFS) is a common anlotinib-related adverse event. The aim of this study was to assess the association of HFS with clinical benefit.
METHODS


A subgroup analysis of patients treated with anlotinib from the ALTER 0303 study was performed. Our analysis assessed if the appearance of anlotinib-related HFS in the first 42 days (second-cycle HFS) and at any time could produce better clinical benefits.
RESULTS


In this study, 294 patients were treated with anlotinib. Of which, 129 patients had HFS at any time, and 76 patients developed HFS in the first 2 cycles. Patients who received anlotinib and developed HFS had significantly prolonged OS, progression-free survival (PFS) compared to those who did not develop HFS in the first 2 cycles (13.5 vs 8.7 months, p = 0.001; adjusted hazard ratio (HR) 0.63 (95% confidence interval [CI] 0.44-0.89), p = 0.009; 5.8 vs 4.5 months, p = 0.001; adjusted HR, 0.59 [0.43-0.81], p = 0.001). The significant OS and PFS benefits for patients with HFS versus without were seen at any time (14.5 vs 7.3 months, p = 0.000; adjusted HR, 0.50 [0.36-0.67], p = 0.000; 5.8 vs 4.2 months, p = 0.000; adjusted HR, 0.49 [0.37-0.65], p = 0.000). In addition, the grade of severity of HFS was strongly correlated with OS (p = 0.000).
CONCLUSION


Presence of HFS may be a potential clinical marker for the treatment of NSCLC with anlotinib.",2020,"Patients who received anlotinib and developed HFS had significantly prolonged OS, progression-free survival (PFS) compared to those who did not develop HFS in the first 2 cycles (13.5 vs 8.7 months, p = 0.001; adjusted hazard ratio (HR) 0.63","['patients with advanced non-small-cell lung cancer receiving', '129 patients had HFS at any time, and 76 patients developed', '294 patients were treated with anlotinib']","['anlotinib', 'HFS', 'placebo']","['grade of severity of HFS', 'overall survival (OS', 'HFS', 'prolonged OS, progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}]","[{'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",294.0,0.273917,"Patients who received anlotinib and developed HFS had significantly prolonged OS, progression-free survival (PFS) compared to those who did not develop HFS in the first 2 cycles (13.5 vs 8.7 months, p = 0.001; adjusted hazard ratio (HR) 0.63","[{'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Nan', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, Shandong Cancer Hospital and Institute, Shandong, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China.'}, {'ForeName': 'Qiujing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shandong Cancer Hospital and Institute, Shandong, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong, China. lj691012@126.com.'}]",International journal of clinical oncology,['10.1007/s10147-020-01683-0']
2044,32447545,Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies.,"INTRODUCTION


Migraine is associated with substantial functional impairment and affects many aspects of daily life.
METHODS


Using data from SAMURAI and SPARTAN (double-blind, placebo-controlled, phase 3 studies) and GLADIATOR (an open-label, phase 3 study enrolling patients who had completed SAMURAI or SPARTAN), we assessed the effects of lasmiditan on migraine-related functional disability at multiple time points from 0.5 to 48 h post dose by asking patients to rate how much the migraine was interfering with normal activities. Pooled data from SAMURAI and SPARTAN (SAMURAI + SPARTAN) and data from GLADIATOR were analyzed using the intention-to-treat populations.
RESULTS


For SPARTAN + SAMURAI, significantly more patients who received lasmiditan at any dose versus placebo reported freedom from migraine-related functional disability at every timepoint from 2 h post dose, and this difference persisted to 48 h (p < 0.05). Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg. Findings from GLADIATOR supported those from SAMURAI + SPARTAN.
CONCLUSION


All doses of lasmiditan resulted in an improvement in migraine-related functional disability that persisted to 48 h. In SAMURAI + SPARTAN, a significant difference from placebo was observed as early as 1 h post dose. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320), SPARTAN (NCT02605174), and GLADIATOR (NCT02565186).",2020,"Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg.",[],['placebo'],['migraine-related functional disability'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.259392,"Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'StudyMetrix Research, St. Peters, MO, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sherie A', 'Initials': 'SA', 'LastName': 'Dowsett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hake', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Emel S M', 'Initials': 'ESM', 'LastName': 'Nery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandy R', 'Initials': 'BR', 'LastName': 'Matthews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. doty_erin_gautier@lilly.com.'}]",Neurology and therapy,['10.1007/s40120-020-00185-5']
2045,32447575,Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer.,"PURPOSE


Treatment of head and neck cancer (HNC) results in severe weight loss, mainly due to the loss of lean body mass. Consequently, decreases in muscular strength and health-related quality of life (HRQL) occur. This study investigated the feasibility of a 12-week novel strength training (NST) and conventional strength training (CST) intervention delivered after HNC treatment.
METHODS


Participants were randomized to a NST group (n = 11) involving eccentric overloaded strength training and neuromuscular electrical stimulation (NMES), or a CST group (n = 11) involving dynamic resistance exercises matched for training volume. Feasibility outcomes included recruitment, completion, adherence, and evidence of progression. A neuromuscular assessment involving maximal isometric voluntary contractions (MIVCs) in the knee extensors was evaluated prior to and during incremental cycling to volitional exhaustion at baseline and after the interventions. Anthropometrics and patient-reported outcomes (PROs) were also assessed.
RESULTS


Although recruitment was challenging, completion was 100% in NST and 82% in CST. Adherence was 92% in NST and 81% in CST. Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
CONCLUSIONS


Both interventions were found to be feasible for HNC patients after treatment. Strength training significantly improved maximal muscle strength, muscle cross-sectional area, and PROs after HNC treatment. Future research should include fully powered trials and consider the use of eccentric overloading and NMES during HNC treatment.
IMPLICATIONS FOR CANCER SURVIVORS


Eccentric- and NMES-emphasized strength training may be useful alternatives to conventional strength training after HNC treatment.",2020,"Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
","['head and neck cancer', 'head and neck cancer (HNC', 'Participants']","['Strength training', 'neuromuscular assessment involving maximal isometric voluntary contractions (MIVCs', 'eccentric overloaded strength training and neuromuscular electrical stimulation (NMES), or a CST group (n = 11) involving dynamic resistance exercises matched for training volume', 'NST', 'novel strength training (NST) and conventional strength training (CST) intervention', 'eccentric overloading and neuromuscular electrical stimulation']","['muscle strength and muscle mass', 'cycling exercise time', 'recruitment, completion, adherence, and evidence of progression', 'HRQL and fatigue', 'Overall, MIVC', 'maximal muscle strength, muscle cross-sectional area, and PROs', 'muscular strength and health-related quality of life (HRQL', 'Adherence']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",,0.0241508,"Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
","[{'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lavigne', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Twomey', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Lau', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Francis', 'Affiliation': 'Division of Physical Medicine & Rehabilitation, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada. guillaume.millet@univ-st-etienne.fr.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00893-9']
2046,32447602,Reduction of fat free mass index and phase angle is a risk factor for development digital ulcers in systemic sclerosis patients.,"INTRODUCTION/OBJECTIVES


This study aims to evaluate the role of fat free mass index (FFMI) and phase angle (PhA) as markers to predict occurrence of new digital ulcers in systemic sclerosis (SSc) patients.
METHODS


Body composition evaluation from bioelectrical impedance and clinical assessment were performed in SSc patients at enrollment and after 12 months follow-up.
RESULTS


Seventy-nine SSc patients (67 female) with a mean age of 53 ± 13 years were enrolled. In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history. After 12 months of follow-up, 30 patients (38%) presented at least one new episode of digital ulcers. Patients with reduced FFMI had a relative risk of 6.7 for new digital ulcers (CI 2.1-21.8, p < 0.001). Patients with reduced PhA had a relative risk of 10.1 for new digital ulcers (CI 3.5-29.5, p < 0.0001). In multivariate analysis, FFMI and PhA were associated with major vascular complication (digital ulcers, pulmonary arterial hypertension, and scleroderma renal crisis). FFMI loss, assessed as delta between follow-up and baseline, is higher in SSc with short duration (≤ 3 years) than SSc patients with long duration [0.4 (0-0.50) vs - 0.10 (- 0.2-0)].
CONCLUSION


In SSc patients, reduction of the FFMI and PhA represents after 12 months a risk factor for development of new digital ulcers and major vascular complication.Key Points• Fat free mass index represents a risk factor for development of digital ulcers• Phase angle represents a risk factor for development of digital ulcers• Body compositions in systemic sclerosis are a marker of activity disease.",2020,"In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history.","['systemic sclerosis (SSc) patients', 'SSc patients at enrollment and after 12\xa0months follow-up', 'Seventy-nine SSc patients (67 female) with a mean age of 53\u2009±\u200913\xa0years were enrolled', 'systemic sclerosis patients']",[],"['FFMI value', 'new digital ulcers', 'major vascular complication (digital ulcers, pulmonary arterial hypertension, and scleroderma renal crisis', 'FFMI loss']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3267035', 'cui_str': 'Digital ulcer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C1262147', 'cui_str': 'Scleroderma renal crisis'}]",79.0,0.0320459,"In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history.","[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Rosato', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy. edoardo.rosato@uniroma1.it.""}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Iacolare', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Maria Ludovica', 'Initials': 'ML', 'LastName': 'Gasperini', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Muscaritoli', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}]",Clinical rheumatology,['10.1007/s10067-020-05141-0']
2047,32447618,Excess volume removal following lung ultrasound evaluation decreases central blood pressure and pulse wave velocity in hemodialysis patients: a LUST sub-study.,"BACKGROUND


Arterial stiffness is a strong predictor of death and cardiovascular (CV) events in hemodialysis patients. Only few studies tested interventions aiming to improve arterial stiffness in this population. This study examines the effect of dry-weight reduction with a standardized lung-ultrasound-guided strategy on ambulatory aortic blood pressure (BP) and arterial stiffness parameters in hemodialysis.
METHODS


Seventy-one clinically euvolemic hemodialysis patients with hypertension, were included in this single-blind randomized clinical-trial. Patients were randomized in the active group (n = 35), following dry-weight reduction guided by the total number of US-B lines before a mid-week dialysis session and the control group (n = 36), following standard treatment. Patients underwent office evaluation of arterial stiffness and 48-h ABPM to capture ambulatory central systolic (cSBP) and diastolic BP (cDBP) and arterial stiffness indexes at baseline and after 8-weeks.
RESULTS


US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up. Office-pulse-wave-velocity (PWV) decreased from baseline to study-end only in the active group, resulting in significant between-group differences (- 0.25 ± 0.71 vs 0.20 ± 1.18 m/s p = 0.037). Reduction in 48-h-cSBP (- 6.30 ± 8.90 vs - 0.50 ± 12.46; p = 0.027) was greater and in cDBP (- 3.85 ± 6.61 vs - 0.63 ± 8.36; p = 0.077) marginally greater in the active compared to control group. 48-h-central-pulse-pressure (cPP, 41.51 ± 9.63 vs 39.06 ± 9.61 mmHg; p = 0.004) and 48-h-PWV (9.30 ± 2.00 vs 9.08 ± 2.04 m/s p = 0.032) were significantly reduced during follow-up in the active group and were unchanged in controls, resulting in significant between-group differences. In contrast, 48-h-AIx and AIx(75) were not different between the two groups.
CONCLUSION


Lung-ultrasound-guided dry-weight reduction decreased ambulatory aortic-BP and ambulatory or office-PWV, but not ambulatory-AIx(75). These results suggest that dry-weight reduction is an important treatment approach to improve these cardiovascular risk factors in hemodialysis.",2020,"RESULTS


US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up.","['Seventy-one clinically euvolemic hemodialysis patients with hypertension', 'hemodialysis patients', 'hemodialysis']","['lung ultrasound evaluation', 'Lung-ultrasound-guided dry-weight reduction', 'dry-weight reduction with a standardized lung-ultrasound-guided strategy']","['ambulatory aortic-BP and ambulatory or office-PWV', 'death and cardiovascular (CV) events', 'ambulatory aortic blood pressure (BP) and arterial stiffness parameters', 'arterial stiffness', 'arterial stiffness and 48-h ABPM to capture ambulatory central systolic (cSBP) and diastolic BP (cDBP) and arterial stiffness indexes', '48-h-PWV', 'cardiovascular risk factors', 'central blood pressure and pulse wave velocity', 'cDBP', 'Office-pulse-wave-velocity (PWV']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",71.0,0.0450903,"RESULTS


US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up.","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'Department of Nephrology, University Clinical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Marieta', 'Initials': 'M', 'LastName': 'Theodorakopoulou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Minopoulou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Pagourelias', 'Affiliation': '3rd Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Douma', 'Affiliation': '3rd Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Asterios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': '2nd Propaedeutic Department of Internal Medicine, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mallamaci', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'London', 'Affiliation': 'Hospital and FCRIN INI-CRCTC, Manhes, France.'}, {'ForeName': 'Pantelis A', 'Initials': 'PA', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. psarafidis11@yahoo.gr.'}]",Journal of nephrology,['10.1007/s40620-020-00745-w']
2048,32447634,Gut Microbial Predictors of Type 2 Diabetes Remission Following Bariatric Surgery.,"PURPOSE


Distinct anatomical rearrangements of the gastrointestinal tract achieved by various types of bariatric surgery cause changes in nutrient intake and gut microbiota. The contribution of such gut microbiota changes to remission of type 2 diabetes (T2D) remains unclear.
AIM


We examined gut microbiota changes following banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) in a randomised study, in relation to T2D remission.
MATERIALS AND METHODS


Whole-metagenome shotgun sequencing was carried out on paired stool samples at pre- and 1-year post-surgery collected from 44 participants with T2D randomised to banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Taxonomic composition and predicted functional potential of the gut bacteria were identified using HUMANn2, and annotated using MetaCyc. Five-day dietary records (analysed using FoodWorks v8.0), body weight and diabetes status were recorded at both time points.
RESULTS


RYGB participants had higher percentage excess weight loss than SG (p = 0.01), even though dietary intake was similar at 1-year post-surgery. Similar proportions achieved diabetes remission (HbA1c < 48 mmol/mol without medications) after either RYGB (68%) or SG (59%). RYGB resulted in increased abundances of Firmicutes and Proteobacteria, while SG resulted in increased Bacteroidetes. Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery. Following surgery, Lachnospiraceae (p = 0.04) and Roseburia (p = 0.01) species were more abundant in those who had achieved T2D remission.
CONCLUSIONS


Specific stool bacterial taxa may signal likelihood of T2D remission after bariatric surgery which is potentially mediated by increases in Lachnospiraceae and Roseburia.",2020,"Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery.","['Type 2 Diabetes Remission Following Bariatric Surgery', '44 participants with T2D randomised to']",['banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG'],"['body weight and diabetes status', 'abundances of Firmicutes and Proteobacteria, while SG resulted in increased Bacteroidetes', 'diabetes remission', 'Alistipes putredinis', 'abundance of Eubacteriaceae', 'Taxonomic composition and predicted functional potential of the gut bacteria', 'percentage excess weight loss']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C1210566', 'cui_str': 'Eubacteriaceae'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",44.0,0.0200876,"Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Davies', 'Affiliation': 'Department of Medicine, Faculty of medical and health sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Faculty of medical and health sciences, University of Auckland, Auckland, New Zealand. r.murphy@auckland.ac.nz.'}]",Obesity surgery,['10.1007/s11695-020-04684-0']
2049,32447635,Weight Loss and Eating Pattern 7 Years After Sleeve Gastrectomy: Experience of a Bariatric Center of Excellence.,"PURPOSE


Report the analysis from a single center series of consecutive primary sleeve gastrectomy (SG) on the factors affecting weight loss at long term.
MATERIALS AND METHODS


Patients submitted to primary SG with a follow-up of 7 years were screened. Weight loss was evaluated with %excess weight loss (%EWL) and %excess BMI loss (%BMIL). Weight regain (WR) was defined as in increase of 25% of the obtained %EWL and insufficient weight loss (IWL) as loss < 50% EWL. Eating behaviors were evaluated with 7 days record (7dR). All the variables potentially affecting the weight loss were cross-matched for correlation. The study population was divided in three groups: group A (WR), group B (IWL), and group C (sustained weight loss) for comparative analysis.
RESULTS


A total of 86 patients (21 M/65 F) with a preoperative BMI of 47.08 ± 6.15 kg/m 2  were evaluated. Cumulative 7 years weight loss was as follows: 61.66 ± 22.69% EWL and 32 ± 9% EBMIL. A total of 4.6% had an IWL while 27.9% a WR. The analysis showed a significant difference among the daily calories and fats consuming, number of meals, physical activity, grazing/sweet eating habits, and adherence to follow-up (p < 0.05) between groups A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9). Eight patients (9.3%) had a surgical revision.
CONCLUSION


Our data demonstrated that long-term results (7 years) of SG are strongly related to eating habits and patient's behaviors.",2020,"A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9).","['86 patients (21 M/65 F) with a preoperative BMI of 47.08\u2009±\u20096.15\xa0kg/m 2  were evaluated', 'Patients submitted to primary SG with a follow-up of 7\xa0years were screened']","['Sleeve Gastrectomy', 'consecutive primary sleeve gastrectomy (SG']","['Weight regain (WR', 'Weight loss', 'surgical revision', 'BMI loss', 'Eating behaviors', 'Weight Loss and Eating Pattern 7\xa0Years', 'weight loss', 'daily calories and fats consuming, number of meals, physical activity, grazing/sweet eating habits, and adherence to follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",86.0,0.0202136,"A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9).","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Iossa', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy. angelo.iossa@gmail.com.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Coluzzi', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Isabella Bianca', 'Initials': 'IB', 'LastName': 'Giannetta', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Silecchia', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04699-7']
2050,32447638,"Effects of Whole-Body Electromyostimulation Associated with Dynamic Exercise on Functional Capacity and Heart Rate Variability After Bariatric Surgery: a Randomized, Double-Blind, and Sham-Controlled Trial.","PURPOSE


Bariatric surgery is the most effective treatment for morbid obesity. In association with dietary restrictions, the ability to exercise in the immediate post-surgical phase is limited. In this context, whole-body electromyostimulation (WB-EMS), strategy that stimulates various muscle groups, in conjunction with physical exercise, holds promise for improving functional capacity, and cardiac autonomic control, following surgery. The purpose of this study was to analyze whether a rehabilitation program consisting of WB-EMS with 30 exercise training sessions following bariatric surgery significantly improves functional capacity, body mass and heart rate variability (HRV).
METHODS


Randomized, double-blind, and sham-controlled trial. Twenty obesity patients were randomized into the WB-EMS (n = 10) and sham (n = 10) groups. On average, 7 days after surgery, individuals underwent a six-minute walk test (6MWT), HRV, and body composition analysis at rest. The next day, patients initiated an exercise training protocol, five times per week, over 6 weeks. Walking distance changes (post-pre = ΔWD) obtained by 6MWT and HRV indices were determined following the intervention.
RESULTS


Only WB-EMSG significantly increased WD and body mass index (BMI) after the intervention (p = 0.002) and ΔWD was significantly higher in this group when compared with sham (p = 0.04). Moreover, both groups demonstrated an improvement in key measures of HRV after the intervention.
CONCLUSION


An exercise training intervention initiated shortly after bariatric surgery improved functional capacity and cardiac autonomic tone. Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.",2020,Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.,['Twenty obesity patients'],"['WB-EMS', 'exercise training intervention', 'Whole-Body Electromyostimulation Associated with Dynamic Exercise', 'exercise training protocol']","['functional capacity and BMI', '6MWT and HRV indices', 'WD and body mass index (BMI', 'HRV', 'functional capacity, body mass and heart rate variability (HRV', 'Functional Capacity and Heart Rate Variability', 'functional capacity and cardiac autonomic tone', 'Walking distance changes']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.380533,Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.,"[{'ForeName': 'Paula Angélica', 'Initials': 'PA', 'LastName': 'Ricci', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Di Thommazo-Luporini', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Soraia Pilon', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Larissa Delgado', 'Initials': 'LD', 'LastName': 'André', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Guilherme Focchi', 'Initials': 'GF', 'LastName': 'Haddad', 'Affiliation': 'Gastro Vita (Medical Specialities Center), Araraquara, SP, Brazil.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil. audrey@ufscar.br.'}]",Obesity surgery,['10.1007/s11695-020-04724-9']
2051,32447641,Potential roles of lymphovascular space invasion based on tumor characteristics provide important prognostic information in T1 tumors with ER and HER2 positive breast cancer.,"PURPOSE


Patients presenting with lymphovascular space invasion (LVSI) had an absolute decrease in survival. In our present study, the potential roles of LVSI on tumor characteristics was explored to predict the difference in the prognosis of ER and HER2 positive T1 tumors.
METHODS


A total of 142 breast cancer patients diagnosed with ER+ and HER2+ tumors whose tumor size was ≤ 2 cm were included in this analysis. One hundred forty-two patients were divided into four groups, group 1 (lymph nodes+ and LVSI+), group 2 (lymph nodes+ and LVSI-), group 3 (lymph nodes- and LVSI+), group 4 (lymph nodes- and LVSI-). Univariate and multivariate Cox proportional hazard models were used to identify independent prognostic factors and calculate the HR and 95% CI. Kaplan-Meier and Cox regression models were used to test the prognostic significance.
RESULTS


LVSI positivity was significantly associated with patient age, menopausal status, tumor size, lymph node status, Ki67, PR, and tumor grade. In the univariate and multivariate model, LVSI, PR, and Ki67 were significantly associated with DFS, and LVSI, lymph node status, PR, and Ki67 were significantly associated with OS. LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups. It was a prognostic factor for DFS but not for OS in women with low Ki67 and was associated with DFS and OS in high-Ki67 tumors. Furthermore, patients who presented with only LVSI had a significantly worse survival rate than those with lymph node metastasis without LVSI in small tumors.
CONCLUSION


The presence of LVSI was highlighted as a variable significant to survival. In further clinical practice, patients with LVSI may need more intensive treatment in certain populations.",2020,LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups.,"['One hundred forty-two patients', '142 breast cancer patients diagnosed with ER+\u2009and HER2+\u2009tumors whose tumor size was\u2009≤\u20092\xa0cm', 'Patients presenting with lymphovascular space invasion (LVSI', 'T1 tumors with ER and HER2 positive breast cancer']","['group 1 (lymph nodes+\u2009and LVSI+), group 2 (lymph nodes+\u2009and LVSI-), group 3 (lymph nodes- and LVSI+), group 4 (lymph nodes- and LVSI']","['LVSI positivity', 'DFS, and LVSI, lymph node status, PR, and Ki67', 'survival rate', 'survival', 'risk of DFS and OS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",142.0,0.023952,LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups.,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Breast Surgery, The Tumor Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of In-Pantient Ultrasound, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Breast Surgery, The Tumor Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of In-Pantient Ultrasound, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150086, Heilongjiang, China. mugong0@163.com.'}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-020-02369-9']
2052,32447738,Responsiveness to muscle mass gain following 12 and 24 weeks of resistance training in older women.,"BACKGROUND


Many factors may influence the magnitude of individual responses to resistance training (RT). How the manipulation of training volume and frequency affects responsiveness level for muscle mass gain in older women has not been investigated.
AIMS


This study had the objective of identifying responders (RP) and non-responders (N-RP) older women for skeletal muscle mass (SMM) gain from a 12-week resistance training (RT) program. Additionally, we analyzed whether the N-RP could gain SMM with an increase in weekly training volume over 12 additional weeks of training.
METHODS


Thirty-nine older women (aged ≥ 60 years) completed 24 weeks of a whole-body RT intervention (eight exercises, 2-3×/week, 1-2 sets of 10-15 repetitions). SMM was estimated by DXA, and the responsive cut-off value was set at two times the standard error of measurement. Participants were considered as RP if they exceeded the cut-off value after a 12-week RT phase, while the N-RP were those who failed to reach the SMM cut-off.
RESULTS


Of the 22 participants considered to be N-RP, only 3 accumulated SMM gains (P = 0.250) that exceeded the cut-off point for responsiveness following 12 additional weeks of training, while 19 maintained or presented negative SMM changes. Of the 17 participants considered to be RP, all continued to gain SMM after the second 12-week RT phase. No significant correlation was observed between the changes in SMM and any baseline aspect of the participants.
CONCLUSIONS


Our results suggest that some older women are RP, while others are N-RP to SMM gains resulting from RT. Furthermore, the non-responsiveness condition was not altered by an increase of training volume and intervention duration while RP participants continue to increase SMM; it appears that RP continue to be RP, and N-RP continue to be N-RP.",2020,"RESULTS


Of the 22 participants considered to be N-RP, only 3 accumulated SMM gains (P = 0.250) that exceeded the cut-off point for responsiveness following 12 additional weeks of training, while 19 maintained or presented negative SMM changes.","['older women', 'responders (RP) and non-responders (N-RP) older women for skeletal muscle mass (SMM) gain from a 12-week resistance training (RT) program', 'Thirty-nine older women (aged\u2009≥']","['whole-body RT intervention', 'resistance training']","['SMM', 'SMM gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",39.0,0.0188554,"RESULTS


Of the 22 participants considered to be N-RP, only 3 accumulated SMM gains (P = 0.250) that exceeded the cut-off point for responsiveness following 12 additional weeks of training, while 19 maintained or presented negative SMM changes.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil. joaonunes.jpn@hotmail.com.'}, {'ForeName': 'Fábio L C', 'Initials': 'FLC', 'LastName': 'Pina', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Bruna D V', 'Initials': 'BDV', 'LastName': 'Costa', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kunevaliki', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Nelson H', 'Initials': 'NH', 'LastName': 'Carneiro', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Analiza M', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Mayhew', 'Affiliation': 'Exercise Science Program, Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01587-z']
2053,32447743,Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety.,"INTRODUCTION


Although use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur.
OBJECTIVE


This analysis reports on pregnancy outcomes in the cladribine clinical development program.
METHODS


Pregnancy outcomes in female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis) were evaluated from an integrated safety analysis of ten studies of cladribine in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with cladribine tablets, parenteral cladribine, or placebo (all-exposed cohort; 1976 patients received cladribine and 802 received placebo). Pregnancies that occurred during the 'at-risk' period for cladribine (during treatment or within 6 months thereafter) are reported as a separate group.
RESULTS


In the all-exposed cohort, 70 direct pregnancies occurred among 62 female patients (cladribine, n = 49; placebo, n = 21). Pregnancy outcomes were: live births (cladribine, n = 19 [38.8%]; placebo, n = 9 [42.9%]), elective terminations (cladribine, n = 14 [28.6%]; placebo, n = 4 [19.0%]), spontaneous abortions (cladribine, n = 11 [22.4%]; placebo, n = 5 [23.8%]), and therapeutic terminations (cladribine, n = 5 [10.2%]; placebo, n = 2 [9.5%]); in the remaining placebo recipient, the pregnancy outcome was unknown. There were two reports of congenital malformations (cladribine, n = 1; placebo, n = 1), both of which occurred with pregnancies arising > 2 years after exposure to the last dose of study medication. Sixteen direct pregnancies occurred during the 'at-risk' period for cladribine; outcomes for these were: live births, n = 3 (18.8%); elective terminations, n = 10 (62.5%); spontaneous abortions, n = 2 (12.5%); and therapeutic terminations, n = 1 (6.2%). Corresponding findings for direct pregnancies among placebo recipients were (n = 11): live births, n = 5 (45.5%); elective terminations, n = 2 (18.2%); spontaneous abortions, n = 3 (27.3%); and unknown, n = 1 (9.1%). No cases of congenital malformation were reported for pregnancies during the 'at-risk' period. There were an additional nine partner pregnancies in female partners of cladribine-treated male patients, all of which resulted in live births; of these, two pregnancies occurred within the 'at-risk' period for cladribine.
CONCLUSIONS


While limited by the small number of pregnancies and related data from the cladribine clinical development program, highlighting the need for further study, the observations made in the present analysis were generally consistent with epidemiological data on pregnancy outcomes for the general population or women with multiple sclerosis. There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose. As the data available for cladribine-exposed pregnancies in patients with multiple sclerosis are limited, a non-interventional post-authorization safety study has been initiated to obtain more information on this subject.
CLINICAL TRIAL REGISTRATION


CLARITY: NCT00213135; CLARITY Extension: NCT00641537; ORACLE MS: NCT00725985; ONWARD: NCT00436826; PREMIERE: NCT01013350.",2020,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"['all-exposed cohort; 1976 patients received', 'female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis', '62 female patients', 'Multiple Sclerosis', 'patients with multiple sclerosis', 'in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with', 'general population or women with multiple sclerosis']","['cladribine', 'cladribine tablets, parenteral cladribine, or placebo', 'cladribine and 802 received placebo', 'Cladribine', 'placebo']","['congenital malformation', 'Pregnancy Outcomes', 'congenital malformations', 'elective terminations', 'therapeutic terminations', 'live births', 'spontaneous abortions']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0919624', 'cui_str': 'Pregnancy of partner'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0987172,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK. g.giovannoni@qmul.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Galazka', 'Affiliation': 'Merck, Aubonne, Switzerland, a division of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Schick', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leist', 'Affiliation': 'Comprehensive MS Center, Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'New Jersey Medical School, Rutgers, The State University of New Jersey, Newark, NJ, USA.'}]",Drug safety,['10.1007/s40264-020-00948-x']
2054,32447767,"Efficacy and safety of Jessner's solution peel in comparison with salicylic acid 30% peel in the management of patients with acne vulgaris and postacne hyperpigmentation with skin of color: a randomized, double-blinded, split-face, controlled trial.","OBJECTIVE


Antibiotics and retinoids have been used for acne vulgaris for decades. Though effective, each has its own drawbacks. Chemical peels have been used for treatment of acne vulgaris with inadequate clinical evidence. We sought to determine the efficacy and safety of Jessner's solution (JS) in comparison with salicylic acid (SA) 30% in the management of acne vulgaris and postacne hyperpigmentation in patients with colored skin.
METHODS


A total of 36 subjects (94.5% Fitzpatick Type IV-V) were recruited in this randomized double-blinded, split-face, controlled trial. Each side of the face was randomly assigned for treatment with either JS or SA. Subjects were treated once fortnightly for a total of three sessions. Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI) were used to objectively assess the improvement. Complications were assessed during each visit. Statistical analysis was conducted using SPSS v22.0. Significance was set at P = 0.05.
RESULTS


At the end of therapy, significant reduction in inflammatory, noninflammatory lesions, MAS, and PAHPI scores (P < 0.001, respectively) were noted in comparison to baseline. Mixed model analysis revealed no significant outcome difference between the two groups. Patients who reported good and very good outcome were 76.4% (JS) and 85.3% (SA). Burning, stinging sensation, and exfoliation were the common complications reported. Postinflammatory hyperpigmentation was reported only once in the JS arm.
CONCLUSION


Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.",2020,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"['patients with colored skin', 'patients with acne vulgaris and postacne hyperpigmentation with skin of color', '36 subjects (94.5% Fitzpatick Type IV-V']","['salicylic acid (SA', ""Jessner's solution (JS"", 'JS or SA', ""Jessner's solution peel"", 'salicylic acid 30% peel']","['Burning, stinging sensation, and exfoliation', 'Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI', 'postacne hyperpigmentation', 'Complications', 'inflammatory, noninflammatory lesions, MAS, and PAHPI scores', 'Postinflammatory hyperpigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0064150', 'cui_str': ""Jessner's solution""}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0040439', 'cui_str': 'Exfoliation of teeth'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]",36.0,0.238022,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"[{'ForeName': 'Kang N', 'Initials': 'KN', 'LastName': 'How', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Poh Y', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra, Serdang, Malaysia.'}, {'ForeName': 'Wan Syazween Lyana', 'Initials': 'WSL', 'LastName': 'Wan Ahmad Kammal', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Norashikin', 'Initials': 'N', 'LastName': 'Shamsudin', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}]",International journal of dermatology,['10.1111/ijd.14948']
2055,32447799,"An extra virgin olive oil-enriched diet improves maternal, placental and cord blood parameters in GDM pregnancies.","AIMS


To address the effect of a diet enriched in extra virgin olive oil (EVOO) on maternal metabolic parameters and placental proinflammatory markers in Gestational diabetes mellitus (GDM) patients.
METHODS


Pregnant women at 24-28 weeks of gestation were enrolled: 33 GDM patients which were randomly assigned or not to the EVOO-enriched group and 17 healthy controls. Metabolic parameters were determined. Peroxisome proliferator activated receptor (PPAR) γ and PPARα protein expression, expression of microRNA (miR)-130a and miR-518d (which respectively target these PPAR isoforms) and levels of proinflammatory markers were evaluated in term placentas. Matrix metalloproteinases (MMPs) activity was evaluated in term placentas and umbilical cord blood.
RESULTS


GDM patients that received the EVOO-enriched diet showed reduced pregnancy weight gain (GDM-EVOO:10.3±0.9, GDM:14.2±1.4, P=0.03) and reduced triglyceridemia (GDM-EVOO:231±14, GDM:292±21, P=0.02) compared to the non-EVOO-enriched GDM group. In GDM placentas, the EVOO-enriched diet did not regulate PPARγ protein expression or miR-130a expression, but prevented the reduced PPARα protein expression (P=0.02 vs GDM) and the increased miR-518d expression (P=0.009 vs GDM). Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P=0.001, P=0.001 and P=0.01 vs GDM). MMPs overactivity was prevented in placenta and umbilical cord blood in the EVOO-enriched GDM group (MMP-9: respectively P=0.01 and P=0.001 vs GDM).
CONCLUSIONS


A diet enriched in EVOO in GDM patients reduced maternal triglyceridemia and weight gain and has anti-inflammatory properties in placenta and umbilical cord blood, possibly mediated by the regulation of PPAR pathways. This article is protected by copyright. All rights reserved.",2020,"Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P=0.001, P=0.001 and P=0.01 vs GDM).","['Pregnant women at 24-28\u2009weeks of gestation were enrolled: 33 GDM patients which were randomly assigned or not to the EVOO-enriched group and 17 healthy controls', 'GDM pregnancies', 'Gestational diabetes mellitus (GDM) patients']","['extra virgin olive oil-enriched diet', 'diet enriched in extra virgin olive oil (EVOO']","['maternal triglyceridemia and weight gain', 'placenta and umbilical cord blood', 'miR-518d expression', 'Peroxisome proliferator activated receptor (PPAR', 'reduced triglyceridemia', 'reduced PPARα protein expression', 'PPARγ protein expression or miR-130a expression', 'Matrix metalloproteinases (MMPs) activity', 'Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas', 'MMPs overactivity', 'maternal metabolic parameters and placental proinflammatory markers', 'γ and PPARα protein expression, expression of microRNA', 'Metabolic parameters', 'pregnancy weight gain', 'maternal, placental and cord blood parameters']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0474395', 'cui_str': 'Behavior showing increased motor activity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",33.0,0.0285214,"Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P=0.001, P=0.001 and P=0.01 vs GDM).","[{'ForeName': 'Dalmiro', 'Initials': 'D', 'LastName': 'Gomez Ribot', 'Affiliation': 'Universidad de Buenos Aires (UBA). Facultad de Medicina, Argentina.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Fazio', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Hebe Lorena', 'Initials': 'HL', 'LastName': 'Gómez', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Daiana', 'Initials': 'D', 'LastName': 'Fornes', 'Affiliation': 'Universidad de Buenos Aires (UBA). Facultad de Medicina, Argentina.'}, {'ForeName': 'Silvia Beatriz', 'Initials': 'SB', 'LastName': 'Macchi', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Gresta', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Evangelina', 'Initials': 'E', 'LastName': 'Capobianco', 'Affiliation': 'Universidad de Buenos Aires (UBA). Facultad de Medicina, Argentina.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jawerbaum', 'Affiliation': 'Universidad de Buenos Aires (UBA). Facultad de Medicina, Argentina.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3349']
2056,32447830,650 usec 1064nm Nd:YAG laser treatment of acne: A double-blind randomized control study.,"BACKGROUND


A variety of energy-based devices have been used to treat acne. However, all studies have been subjective and have not involved double-blind and randomized controlled studies.
AIMS


We undertook a randomized controlled study evaluating the use of a 650 usec 1064 nm Nd:YAG laser compared with a sham in the treatment of acne.
PATIENTS/METHODS


A total of 20 subjects with moderate-to-severe acne were randomized to receive either 650 usec 1064nm Nd:YAG laser or sham treatment. All subjects received 3 treatments, two weeks apart, plus an additional session undertaken 4 weeks after the 3rd treatment. Subjects were evaluated for investigator global improvement, improvement in inflammatory lesions, improvement in comedonal lesions, total porphyrin score, and total sebum score.
RESULTS


The laser-treated group showed an Investigator's Global Assessment Scale (IGA) improvement of 26% compared with 7% for the sham group (a 271% improvement over sham treatment group). The treatment group also showed a decrease in the number of inflammatory lesions of 42% compared with 26% in the sham group (a 62% improvement over sham). The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score. There was also an 18% reduction in sebum production in the treated group, compared with 9% in the sham group (a 100% improvement).
CONCLUSION


This is the first study that has compared laser treatment of acne compared with a sham treatment. A 650 usec 1064nm Nd:YAG laser can effectively treat acne.",2020,The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score.,"['A 650 usec 1064nm', '650 usec 1064nm Nd', '650 usec 1064\xa0nm Nd', '20 subjects with moderate-to-severe acne']","['YAG laser', 'YAG laser or sham treatment', 'Nd:YAG laser', 'YAG laser treatment of acne']","['sebum production', ""Investigator's Global Assessment Scale (IGA) improvement"", 'number of inflammatory lesions', 'investigator global improvement, improvement in inflammatory lesions, improvement in comedonal lesions, total porphyrin score, and total sebum score', 'total porphyrin score', 'total number of comedones']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0439224', 'cui_str': 'us'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032712', 'cui_str': 'Porphyrin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221228', 'cui_str': 'Comedone'}]",20.0,0.178718,The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Kesty', 'Affiliation': 'Skin Laser and Surgery Specialists of NY & NJ, Hackensack, NJ, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': 'Skin Laser and Surgery Specialists of NY & NJ, Hackensack, NJ, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13480']
2057,32447856,[Clinical effect of electroacupuncture at Baihui and Shuigou points in treatment of brain injury in patients with sepsis-associated encephalopathy].,"OBJECTIVE


To investigate the clinical effect of electroacupuncture at Baihui (GV20) and Shuigou (GV26) points in the treatment of brain injury in patients with sepsis-associated encephalopathy(SAE).
METHODS


A total of 70 patients with SAE were randomly divided into control group and treatment group, with 35 patients in each group. The patients in the control group were given routine western medicine treatment, including anti-infective therapy, nerve nutrition, and mechanical ventilation, and those in the treatment group were given electroacupuncture at GV20 and GV26 in addition to the treatment in the control group. The course of treatment was 1 week for both groups. Serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), and neuron-specific enolase (NSE) were measured for both groups, the Montreal Cognitive Assessment (MoCA) scale was used to assess the change in cognitive function, and Glasgow Coma Scale (GCS) score was determined before and after treatment and was used to evaluate treatment outcome after treatment.
RESULTS


Both groups had significant reductions in the serum levels of CRP, IL-6, and NSE after 24 h and one week of treatment ( P <0.05), and compared with the control group, the treatment group had significant reductions in the levels of CRP, IL-6 and NSE after treatment ( P <0.05). The treatment group had significant increases in the total score of MoCA and the scores of all dimensions except attention after one week of treatment ( P <0.05), and the treatment group had significantly higher scores than the control group after treatment ( P <0.05). Both groups had a significant increase in GCS score after one week of treatment ( P <0.05), and the treatment group had a significantly higher GCS score than the control group after treatment ( P <0.05). The treatment group had a significantly higher total effective rate than the control group ［88.6% (31/35) vs 57.1% (20/35),  P <0.05］.
CONCLUSION


Electroacupuncture at GV20 and GV26 can effectively improve brain injury and effective rate in SAE patients.",2020,"Both groups had significant reductions in the serum levels of CRP, IL-6, and NSE after 24 h and one week of treatment ( P <0.05), and compared with the control group, the treatment group had significant reductions in the levels of CRP, IL-6 and NSE after treatment ( P <0.05).","['patients with sepsis-associated encephalopathy', '70 patients with SAE', 'patients with sepsis-associated encephalopathy(SAE']","['routine western medicine treatment, including anti-infective therapy, nerve nutrition, and mechanical ventilation', 'electroacupuncture at Baihui (GV20) and Shuigou (GV26', 'electroacupuncture', 'Electroacupuncture', 'electroacupuncture at Baihui and Shuigou points']","['Serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), and neuron-specific enolase (NSE', 'serum levels of CRP, IL-6, and NSE', 'total effective rate', 'total score of MoCA', 'Montreal Cognitive Assessment (MoCA) scale', 'change in cognitive function, and Glasgow Coma Scale (GCS) score', 'brain injury and effective rate', 'GCS score', 'levels of CRP, IL-6 and NSE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393642', 'cui_str': 'Sepsis-associated encephalopathy'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1141958', 'cui_str': 'Anti-infective therapy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0450806', 'cui_str': 'GV26'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]",70.0,0.022085,"Both groups had significant reductions in the serum levels of CRP, IL-6, and NSE after 24 h and one week of treatment ( P <0.05), and compared with the control group, the treatment group had significant reductions in the levels of CRP, IL-6 and NSE after treatment ( P <0.05).","[{'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Zheng', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Feng-Li', 'Initials': 'FL', 'LastName': 'Zhao', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Xin-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Min-Yong', 'Initials': 'MY', 'LastName': 'Wen', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190781']
2058,32447857,[Assessment of efficacy of acupuncture combined with hyperbaric oxygen therapy for patients with delayed encephalopathy of CO intoxication by magnetic resonance voxel incoherent motion imaging].,"OBJECTIVE


To observe the effect of acupuncture plus hyperbaric oxygen (HBO) on cerebral blood perfusion in patients with delayed encephalopathy after carbon monoxide poisoning (DEACMP).
METHODS


Twenty-eight patients with DEACMP were randomly divided into acupuncture group ( n =14 cases) and control group ( n =14 cases). Patients of the acupuncture group were treated by using ""Xingnao Kaiqiao"" needling technique (specific set of acupuncture points as Yintang ［EX-HN3］, Shangxing ［GV23］, Baihui ［GV20］, Sishenchong ［EX-HN1］, Fengchi ［GB20］, Taichong ［LR3］, etc., and strong stimulation) combined with HBO in an air pressurized tank, and those of the control group treated by simple HBO. The treatment was conducted once a day, 5 days a week for 6 weeks. All the patients underwent head routine magnetic resonance imaging (MRI) and intravoxel incoherent motion imaging(IVIM) scan before and after the treatment. The values of pseudo-diffusion coefficient D (D*) and perfusion fraction (f) of the bilateral semi-oval centers were measured by using MITK software package to calculate the ave-rage fD* value (f×D*). The Barthel index (BI) score was used to assess the patients' daily living ability, and the correlation between parameter values was evaluated by Pearson method.
RESULTS


After the treatment, the values of f, fD* and BI scores were significantly increased in both acupuncture group and control groups ( P <0.05). The values of the 3 indexes were significantly higher in the acupuncture group than those in the control group ( P <0.05). The values of f and fD* were positively correlated with BI score ( P <0.05), with the correlation coefficients being 0.822, 0.636 and 0.601, respectively between the fD* and f, BI and f, and BI and fD*.
CONCLUSION


Acupuncture combined with HBO can significantly improve the low-perfusion of bilate-ral semi-oval center and daily living ability in patients with DEACMP, being significantly superior to simple HBO therapy in the curative effect.",2020,The values of the 3 indexes were significantly higher in the acupuncture group than those in the control group ( P <0.05).,"['patients with delayed encephalopathy of CO intoxication by magnetic resonance voxel incoherent motion imaging', 'Twenty-eight patients with DEACMP', 'patients with delayed encephalopathy after carbon monoxide poisoning (DEACMP']","['acupuncture', 'head routine magnetic resonance imaging (MRI) and intravoxel incoherent motion imaging(IVIM) scan', 'Acupuncture combined with HBO', 'acupuncture combined with hyperbaric oxygen therapy', 'Xingnao Kaiqiao"" needling technique (specific set of acupuncture', 'acupuncture plus hyperbaric oxygen (HBO']","['low-perfusion of bilate-ral semi-oval center and daily living ability', 'values of f, fD', 'BI score', ' and BI scores', 'cerebral blood perfusion', 'values of pseudo-diffusion coefficient D (D*) and perfusion fraction (f) of the bilateral semi-oval centers', 'Barthel index (BI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0542044', 'cui_str': 'Incoherent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0007020', 'cui_str': 'Carbon monoxide poisoning'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0542044', 'cui_str': 'Incoherent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",28.0,0.0332464,The values of the 3 indexes were significantly higher in the acupuncture group than those in the control group ( P <0.05).,"[{'ForeName': 'Guan-Wen', 'Initials': 'GW', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Yan-Li', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Tian-Hong', 'Initials': 'TH', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, First Hospital of Lanzhou University, Lanzhou 730000, China.'}, {'ForeName': 'You-Quan', 'Initials': 'YQ', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, First Hospital of Lanzhou University, Lanzhou 730000, China.'}, {'ForeName': 'Jun-Qiang', 'Initials': 'JQ', 'LastName': 'Lei', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Mao-Mao', 'Initials': 'MM', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Wan-Jun', 'Initials': 'WJ', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}, {'ForeName': 'Shun-Lin', 'Initials': 'SL', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, First Hospital of Lanzhou University, Lanzhou 730000, China; First Clinical Medical College of Lanzhou University, Lanzhou 730000.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.180678']
2059,32447858,[Application of nerve trunk stimulation therapy in functional rehabilitation of the lower limbs in the patients with cerebral apoplexy at convalescence stage].,"OBJECTIVE


To explore the value of nerve trunk stimulation in the rehabilitation of lower limb function in the patients with cerebral apoplexy at convalescence stage.
METHODS


According the random number table, the patients with the lower limb dysfunction of cerebral apoplexy at convalescence stage were divided into a control group and a treatment group, 42 cases in each group. The drug therapy and the routine rehabilitation training were provided in the two groups. Additionally, in the treatment group, the nerve trunk stimulation therapy was adopted， in which, Chize (LU5，stimulating point of radial nerve), Neiguan (PC6, stimulating point of median nerve), Xiaohai (SI8, stimulating point of ulnar nerve) were selected. In the control group, acupuncture intervention was supplemented. Before and after treatment, the peak torque (PT) of the lower flexor-extensor muscle of the knee joint, gait parameters，the score of the modified Ashworth spasm scale (MAS), the score of Fugl-Meyer motor assessment (FMA) and the score of Fugl-Meyer balance scale (FBS) were recorded.
RESULTS


After the treatment, the PT of the lower flexor-extensor muscle of the knee joint，the scores of FMA and FBS，the step speed and frequency were all increased, the score of MAS and the difference in the stride between the left and the right were decreased as compared with those before treatment ( P <0.01). After the treatment, The PT of the lower flexor-extensor muscle of the knee joint，the scores of FMA and FBS，the step speed and frequency in the treatment group were higher than those in the control group ( P <0.01). The score of MAS and the difference in the stride between the left and the right in the treatment group were lower than those in the control group ( P <0.01).
CONCLUSION


Nerve trunk stimulation therapy quite effectively increases the muscle strength and relieves the muscle tension as well as improves the motor function, the balance and the walking pattern of the lower limbs. This therapy is significantly valuable in the rehabilitation of the lower limbs in the patients with cerebral apoplexy at convalescence stage.",2020,"The score of MAS and the difference in the stride between the left and the right in the treatment group were lower than those in the control group ( P <0.01).
","['patients with cerebral apoplexy at convalescence stage', 'patients with the lower limb dysfunction of cerebral apoplexy at convalescence stage']","['acupuncture intervention', 'routine rehabilitation training', 'Nerve trunk stimulation therapy', 'nerve trunk stimulation therapy']","['score of MAS', 'muscle strength', 'PT of the lower flexor-extensor muscle of the knee joint，the scores of FMA and FBS，the step speed and frequency', 'peak torque (PT) of the lower flexor-extensor muscle of the knee joint, gait parameters，the score of the modified Ashworth spasm scale (MAS), the score of Fugl-Meyer motor assessment (FMA) and the score of Fugl-Meyer balance scale (FBS', 'flexor-extensor muscle of the knee joint，the scores of FMA and FBS，the step speed and frequency', 'nerve trunk stimulation therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.0173654,"The score of MAS and the difference in the stride between the left and the right in the treatment group were lower than those in the control group ( P <0.01).
","[{'ForeName': 'Jia-Xu', 'Initials': 'JX', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, Shenzhen Pingle Orthopedic Hospital, Pingshan Hospital of Traditional Chinese Medicine, Shenzhen 518101, Guangdong Province, China.'}, {'ForeName': 'Kai-Chao', 'Initials': 'KC', 'LastName': 'Shao', 'Affiliation': 'Department of Rehabilitation, Shenzhen Pingle Orthopedic Hospital, Pingshan Hospital of Traditional Chinese Medicine, Shenzhen 518101, Guangdong Province, China.'}, {'ForeName': 'Chang-Wu', 'Initials': 'CW', 'LastName': 'Lu', 'Affiliation': 'Department of Rehabilitation, Shenzhen Pingle Orthopedic Hospital, Pingshan Hospital of Traditional Chinese Medicine, Shenzhen 518101, Guangdong Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190643']
2060,32447890,[Psychological health of nurses in operating room participating in organ donation and intervention effect].,"Objective:  To understand the effect of organ donation surgery on the mental health of nurses in operating room, and to explore the intervention effects.  Methods:  From Jan.2015 to Dec. 2018, 60 operating room nurses in our hospital participating in organ donation surgery were selected for investigation of mental health, and were intervened by group psychological training, positive psychological intervention, improving shift arrangement system and financial support. The SCL-90 scale and DAP-R scale were used to evaluate before and after intervention.  Results:  The mean scores of somatization, interpersonal sensitivity, depression, anxiety, terror, paranoia and psychoticism in SCL-90 scale of 60 operating room nurses were (2.07±0.63) , (2.07±0.69) , (1.88±0.62) , (1.71±0.57) , (1.78±0.67) , (1.71±0.68) , (1.73±0.60) before intervention respectively, which were significantly higher than the Chinese norm ( P <0.01) and those[ (1.64±0.60) , (1.46±0.57) , (1.53±0.62) , (1.48±0.60) , (1.28±0.50) , (1.45±0.56) , (1.43±0.52) ] after intervention were lower than before ( P <0.01) . Before and after the intervention, the scores of DAP-R scale tended to be death fear dimension and acceptance dimension, the proportion of the death fear dimension was 16.7% (10/60) and 6.7% (4/60) , respectively, and the approaching acceptance dimension was 83.3% (50/60) and 93.3% (56/60) . The proportion of the nurses with scores of SCL-90 scale ≥160 after the intervention was significantly lower than that before the intervention (χ(2)=5.82,  P <0.05) .  Conclusion:  The mental health of nurses in the operating room participating in organ donation surgery is lower; After intervention, the investigated nurses present improved mental health and positively emotional attitude towards death.",2020,"The mental health of nurses in the operating room participating in organ donation surgery is lower; After intervention, the investigated nurses present improved mental health and positively emotional attitude towards death.","['From Jan.2015 to Dec. 2018, 60 operating room nurses in our hospital participating in organ donation surgery']","['psychological training, positive psychological intervention, improving shift arrangement system and financial support', 'organ donation surgery']","['scores of DAP-R scale', 'proportion of the nurses with scores of SCL-90 scale', 'death fear dimension and acceptance dimension, the proportion of the death fear dimension', 'SCL-90 scale and DAP-R scale', 'mean scores of somatization, interpersonal sensitivity, depression, anxiety, terror, paranoia and psychoticism in SCL-90 scale of 60 operating room nurses', 'mental health and positively emotional attitude towards death']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0016118', 'cui_str': 'Financial Support'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0223987,"The mental health of nurses in the operating room participating in organ donation surgery is lower; After intervention, the investigated nurses present improved mental health and positively emotional attitude towards death.","[{'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Peng', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Wu', 'Affiliation': 'Operating Room, Tianjin First Central Hospital, Tianjin 300192, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20190521-00207']
2061,32447892,[Application of the situational simulation teaching method in occupational protection training for medical staff].,"Objective:  To investigate a new method for occupational protection training for medical staff, and to improve the awareness of occupational protection among medical staff.  Methods:  In August 2018, convenience sampling was performed to select 171 new medical workers in a grade A tertiary teaching hospital as subjects. The subjects were trained according to the requirements for occupational protection knowledge and training objectives. A questionnaire was distributed before training, and the scores were collected as control group; the subjects were trained using the conventional PPT theory, a questionnaire was distributed after training, and the scores were collected as trial group 1; the subjects were trained using the conventional PPT theory combined with the situational simulation teaching method, a questionnaire was distributed after training, and the scores were collected as trial group 2. A total of 171 questionnaires were distributed and collected for each survey, with a questionnaire recovery rate of 100%. Continuous data were expressed as mean±SD and were evaluated by an analysis of variance; categorical data were expressed as rate (%) , and the chi-square test was used for analysis.  Results:  A total of 171 medical workers, aged 22-33 years (mean 23.63±2.33 years) , participated in the study, among whom 127 (74.27%) were nurses, 146 (85.38%) were female workers, and 93 (54.39%) had a college degree. The awareness rate of occupational protection knowledge was 24.56%-70.18% in the control group, 63.16%-96.49% in the trial group 1, and 86.55%-99.42% in the trial group 2. There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) . Theoretical test score, skill assessment score, and total score tended to increase after the training based on the conventional PPT theory or the training based on the conventional PPT theory and situational simulation ( F =125.042, 352.025, and 444.073,  P <0.01) .  Conclusion:  The situational simulation teaching method for the training of occupational protection knowledge for medical staff has a marked training effect and can significantly improve the theoretical and skill levels of medical staff.",2020,"There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) .","['A total of 171 medical workers, aged 22-33 years (mean 23.63±2.33 years) , participated in the study, among whom 127 (74.27%) were nurses, 146 (85.38%) were female workers, and 93 (54.39%) had a college degree', 'medical staff', '171 new medical workers in a grade A tertiary teaching hospital as subjects']","['situational simulation teaching method in occupational protection training', 'occupational protection training', 'conventional PPT theory combined with the situational simulation teaching method']","['Theoretical test score, skill assessment score, and total score', 'theoretical test score, skill assessment score, and total score', 'awareness rate of occupational protection knowledge']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",171.0,0.0201023,"There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) .","[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Zhu', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Wang', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20190321-00110']
2062,32448015,"Effects of the model of human occupation-based home modifications on the time use, occupational participation and activity limitation in people with disabilities: a pilot randomized controlled trial.","Purpose:  To compare the effect of intervention providing home modifications and assistive devices based on MOHO theory with home exercise on people with disability in time use, competence and values of occupational performance and activity limitations. Methods:  Participants were 20 people with disabilities due to deficits in central nervous system. Eleven people in the experimental group partook in environmental modifications and assistive device intervention and nine people in the control partook in home exercise programmes. A total of eight sessions were progressed, one pre-test, six sessions of interventions and one post-test. Occupational Questionnaire (OQ) was used to evaluate one's time use. Occupational Self Assessment (OSA) was used to test the competence and values of one's everyday occupational performance. Activity Limitations Measure (ACTIVLIM) was used to assess the activity limitation of one's functional ability. Wilcoxon signed rank test was used to analyse the comparison of the pre-post of time use, competence and values of occupational performance, and activity limitations. Mann-Whitney  U  was used to compare between both groups. Results:  Among the four occupational areas of OQ, the participation time in ADL significantly increased and rest significantly decreased in the experimental group ( p <.05). The competence of occupational performance also increased in the experimental group whereas the values of occupational performance increased in the control group ( p <.05). The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group. Conclusions:  Using the interaction between human and environment for environmental modification increased the time use in occupational participation and competence to perform occupation in people with disability. By applying MOHO theory to evaluate and modify one's home environment and activity performance, we could comprehend the life style of clients and suggest opportunities to actively participate in ADLs.Implications for rehabilitationUsing the interaction between human and environment for environmental modification increased the time use in occupational participation and competence to perform occupation in people with disability.By applying MOHO theory to evaluate and modify one's home environment, we could comprehend the life style of clients and suggest opportunities to actively participate in ADLs.Adapting MOHO theory to enhance activity participation will contribute to enhance the quality of occupational therapy services in community settings.",2020,The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group.,"['people with disabilities', 'Eleven people in the experimental group partook in environmental modifications and assistive device intervention and nine people in the control partook in home exercise programmes', '20 people with disabilities due to deficits in central nervous system', 'people with disability']","['human occupation-based home modifications', 'Occupational Self Assessment (OSA', 'MOHO theory with home exercise']","['Occupational Questionnaire (OQ', 'competence of occupational performance', 'participation time in ADL', 'time use, occupational participation and activity limitation', 'people with disability in time use, competence and values of occupational performance and activity limitations', 'values of occupational performance', 'activity limitation']","[{'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0325748', 'cui_str': 'Porphyrio mantelli'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0243273,The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group.,"[{'ForeName': 'Ye-Ji', 'Initials': 'YJ', 'LastName': 'Jo', 'Affiliation': 'Department of Occupational Therapy, Konyang University, Dae-jeon, Republic of Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Konyang University, Dae-jeon, Republic of Korea.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1768306']
2063,32448017,The effects of an intradialytic resistance training on lower extremity muscle functions.,"Purpose:  The loss of muscle functions is a significant health issue among dialysis patients. Poor muscle strength negatively affects a patient's mobility, independence and quality of life. The aim of the study was to assess the effects of an intradialytic resistance training (IRT) on lower extremity muscle functions among dialysed patients. Materials and methods:  Ninety patients were allocated into an experimental group ( n  = 57) or control group (CNG) ( n  = 33) according to the location of the dialysis service center. Fifty-eight patients completed the study follow-up. The intervention regarded 12-week IRT, while the controls remained physically inactive during hemodialysis. In both groups of patients, we assessed lower extremity muscle functions by a diagnostics of maximal isometric force generated during hip flexion (HF), hip extension (HE), and knee extension (KE) contractions at baseline, after the 12-weeks intervention and after a further 12-weeks follow up. Results:  We found that improvements in HE between baseline and post-intervention were significantly larger for the experimental than the CNG (difference 32.0, 95% CI = 12.3-51.8,  p  = 0.002). For the other primary outcomes, we found no differences between the groups, and neither for the two other indices of muscle strength (HF and KE). At 12-weeks follow-up, we found no statistically significant differences between the two groups. Conclusions:  Our findings indicate that exercise during dialysis not just suppresses adverse effects in muscle strength and functioning, but effectively and safely increases lower extremities muscle function in a relatively short time.Implications for RehabilitationRegular, progressive, resistance training realized during dialysis is well tolerated and safe for exercise interventions in hemodialysis patients.A 12-weeks intradialytic resistance training is effective in the prevention and clinical management of muscle function loss among hemodialysis patients.The range of improvements in muscle functions, demonstrated by the assessment of maximal isometric force, varied severely during different lower extremity movements of hemodialysis patients.",2020,"For the other primary outcomes, we found no differences between the groups, and neither for the two other indices of muscle strength (HF and KE).","['Fifty-eight patients completed the study follow-up', 'dialysed patients', 'Ninety patients', 'dialysis patients', 'hemodialysis patients']","['control group (CNG', 'intradialytic resistance training', 'intradialytic resistance training (IRT']","['maximal isometric force generated during hip flexion (HF), hip extension (HE), and knee extension (KE) contractions', ""patient's mobility, independence and quality of life"", 'extremities muscle function', 'muscle strength (HF and KE']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",90.0,0.0137849,"For the other primary outcomes, we found no differences between the groups, and neither for the two other indices of muscle strength (HF and KE).","[{'ForeName': 'Aurel', 'Initials': 'A', 'LastName': 'Zelko', 'Affiliation': 'Department of Health Psychology and Research Methodology, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Health Psychology and Research Methodology, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Skoumalova', 'Affiliation': 'Department of Health Psychology and Research Methodology, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolarcik', 'Affiliation': 'Department of Health Psychology and Research Methodology, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Madarasova Geckova', 'Affiliation': 'Department of Health Psychology and Research Methodology, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Jitse P', 'Initials': 'JP', 'LastName': 'van Dijk', 'Affiliation': 'Graduate School Kosice Institute for Society and Health, Faculty of Medicine, Pavol Jozef Safarik University, Kosice, Slovakia.'}, {'ForeName': 'Sijmen A', 'Initials': 'SA', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Community and Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1766581']
2064,32448020,Glutamatergic and GABAergic reactivity and cognition in 22q11.2 deletion syndrome and healthy volunteers: A randomized double-blind 7-Tesla pharmacological MRS study.,"AIMS


22q11.2 deletion syndrome (22q11.2DS) is associated with impaired cognitive functioning. Glutamatergic pathways have been linked with cognition and are hypothesized to be disrupted in 22q11.2DS patients, possibly 'shifting' the excitatory (glutamate)/inhibitory (GABA) balance. Hence, the glutamate/GABA balance may constitute a target for pharmacological treatment. We aimed to examine alterations of glutamate/GABA metabolites in 22q11.2DS  in vivo  using riluzole, a compound with glutamate/GABA-modulating action, as pharmacological challenge.
METHODS


Seventeen 22q11.2DS patients and 20 matched healthy controls were enrolled in this randomized double-blind placebo-controlled crossover study. Glutamate and glutamine concentrations in the anterior cingulate cortex (ACC) and striatum, as well as ACC GABA concentrations were obtained after placebo and after a single dose of 50 mg riluzole using 7-Tesla magnetic resonance spectroscopy (MRS). Within the 22q11.2DS group, the relationship between metabolite concentrations and cognition was examined.
RESULTS


No group differences were found in ACC and striatal metabolite concentrations following placebo. Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects. In both regions, riluzole did not alter glutamine concentration. No interaction effects were found. Although not significant after Bonferroni correction, ACC glutamate concentrations were inversely correlated with cognitive functions in 22q11.2DS patients.
DISCUSSION


We did not demonstrate altered ACC and striatal metabolite concentrations in 22q11.2DS. Nevertheless, these results suggest that glutamate and GABA can be modulated with a single dose of riluzole. Possibly, riluzole may have memory-enhancing effects in 22q11.2DS. Future studies should examine the long-term effects of riluzole on cognition.",2020,Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects.,"['Seventeen 22q11.2DS patients and 20 matched healthy controls', '22q11.2 deletion syndrome and healthy volunteers', '22q11.2DS patients']","['Riluzole', 'riluzole', 'placebo']","['ACC GABA concentrations', 'ACC glutamate concentrations', 'ACC and striatal metabolite concentrations', 'cognitive functions', 'ACC', 'glutamine concentration']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0220704', 'cui_str': 'Velo-cardio-facial syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012236', 'cui_str': ""DiGeorge's syndrome""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",,0.0789898,Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vingerhoets', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Desmond Hy', 'Initials': 'DH', 'LastName': 'Tse', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'van Oudenaren', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hernaus', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Duin', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Zinkstok', 'Affiliation': 'Department of Psychiatry & UMC Utrecht Brain Center, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jacobus Fa', 'Initials': 'JF', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'McAlonan', 'Affiliation': ""The Sackler Institute for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922977']
2065,32448056,Mindfulness Meditation Improves Visual Short-Term Memory.,"Research into the effects of mindfulness meditation on behavioral outcomes has received much interest in recent years, with benefits for both short-term memory and working memory identified. However, little research has considered the potential effects of brief mindfulness meditation interventions or the nature of any benefits for visual short-term memory. Here, we investigate the effect of a single, 8-minute mindfulness meditation intervention, presented via audio recording, on a short-term memory task for faces. In comparison with two control groups (listening to an audiobook or simply passing the time however they wished), our mindfulness meditation participants showed greater increases in visual short-term memory capacity from pre- to post-intervention. In addition, only mindfulness meditation resulted in significant increases in performance. In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.",2020,"In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.",[],"['Mindfulness Meditation', '8-minute mindfulness meditation intervention, presented via audio recording, on a short-term memory task for faces', 'mindfulness meditation intervention', 'mindfulness meditation']","['performance', 'visual short-term memory capacity']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0183068,"In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Youngs', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Samuel E', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Mireku', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Dinkar', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'Robin S S', 'Initials': 'RSS', 'LastName': 'Kramer', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}]",Psychological reports,['10.1177/0033294120926670']
2066,32448089,"DEVT: A randomized, controlled, multicenter trial of direct endovascular treatment versus standard bridging therapy for acute stroke patients with large vessel occlusion in the anterior circulation - Protocol.","BACKGROUND


Eight randomized controlled trials have consistently shown that endovascular treatment plus best medical treatment improves outcome after acute anterior proximal intracranial large vessel occlusion strokes. Whether intravenous thrombolysis prior to endovascular treatment in patients with anterior circulation, large vessel occlusion is of any additional benefits remains unclear.
OBJECTIVE


This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.
METHODS AND DESIGN


The DEVT study is a randomized, controlled, multicenter trial with blinded outcome assessment. This trial uses a five-look group-sequential non-inferiority design. Up to 194 patients in each interim analysis will be consecutively randomized to direct endovascular treatment or bridging therapy group in 1:1 ratio over three years from about 30 hospitals in China.
OUTCOMES


The primary end-point is the proportion of independent neurological function defined as modified Rankin scale score of 0 to 2 at 90 days. The primary safety measure is symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days.
TRIAL REGISTRY NUMBER


ChiCTR-IOR-17013568 ( www.chictr.org.cn ).",2020,"This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.
","['194 patients in each interim analysis will be consecutively randomized to', 'acute anterior proximal intracranial large vessel occlusion strokes', 'patients with anterior circulation, large vessel occlusion', 'acute stroke patients with large vessel occlusion in the anterior circulation - Protocol', 'group in 1:1 ratio over three years from about 30 hospitals in China', 'acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5\u2009h of symptom onset']","['standard bridging therapy', 'direct endovascular treatment', 'direct endovascular treatment or bridging therapy', 'direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy']","['proportion of independent neurological function defined as modified Rankin scale score', 'safety and efficacy', 'symptomatic intracerebral hemorrhage at 48\u2009h and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.143072,"This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.
","[{'ForeName': 'Zhongming', 'Initials': 'Z', 'LastName': 'Qiu', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Hansheng', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Fengli', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Deping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': ""Department of Neurosurgery, The 904th Hospital of The People's Liberation Army, Wuxi, China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Wenguo', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Chinese Medical Hospital of Maoming, Maoming, China.'}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zigong, Zigong, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Third People's Hospital of Zigong, Zigong, China.""}, {'ForeName': 'Shiquan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, The 902th Hospital of The People's Liberation Army, Bengbu, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The First People's Hospital of Yangzhou, Yangzhou University, Yangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Fifth People's Hospital of Chengdu, Chengdu, China.""}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Henan Science and Technology University, Luoyang, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xiangyang Central Hospital, Hubei Arts and Science University, Xiangyang, China.'}, {'ForeName': 'Huagang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Lu'an Affiliated Hospital of Anhui Medical University, Lu'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Neurology, Hubei Zhongshan Hospital, Wuhan, China.'}, {'ForeName': 'Zhibing', 'Initials': 'Z', 'LastName': 'Ai', 'Affiliation': 'Department of Neurology, Taihe Affiliated Hospital of Hubei Medical University, Shiyan, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': ""Department of Neurology, The First People's Hospital of Chenzhou, Chenzhou, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, The 404th hospital of Mianyang, Mianyang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': ""Department of Neurology, Hubei Province People's Hospital, Wuhan, China.""}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Shouchun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Neurology, Nanyang Central Hospital, Nanyang, China.'}, {'ForeName': 'Wentong', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ""Department of Neurology, Zhongshan People's Hospital, Zhongshan, China.""}, {'ForeName': 'Shudong', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing Key Laboratory of Cerebrovascular Disease Research, Chongqing, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, Ganzhou People's Hospital, Ganzhou, China.""}, {'ForeName': 'Youlin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Neurology, Chongzhou People's Hospital, Chongzhou, China.""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Department of Neurosurgery, The Second People's Hospital of Huaiyuan, Huaiyuan, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': ""Department of Neurology, Deyang People's Hospital, Deyang, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Neurology, The First People's Hospital of Xiangyang, Hubei Medical University, Xiangyang, China.""}, {'ForeName': 'Luming', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Chengsong', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Zili', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shuai', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Sang', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Zi', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': 'Qingwu', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020925349']
2067,32448136,Application of CareDose 4D combined with Karl 3D technology in the low dose computed tomography for the follow-up of COVID-19.,"BACKGROUND


Coronavirus disease 2019 (COVID-19) is a highly infectious disease caused by the new coronavirus. Previous studies have shown that the chest CT examination plays an important role in the diagnosis and monitoring of COVID-19. However, some patients with COVID-19 had low white blood cell counts and reduced lymphocyte ratios. Multiple CT examinations may cause radiation damages as well as increase the apoptosis of peripheral blood lymphocytes. A new low-dose CT method should be developed because the regular CT may aggravate the disease.
METHOD


Sixty cases were randomly divided into the study group (n = 30) and control group (n = 30). The lung window was reconstructed by Karl 3D iterative technique in the study group. The image quality was subjectively evaluated by two senior chest group diagnostic physicians using a 5-point double-blind method. The value of CT measurement and its standard deviation (SD) was used as an objective evaluation criteria. The volume of CT dose index (CTDI vol ), dose length product (DLP) and effective dose (ED) from the two groups were compared and analyzed statistically.
RESULT


There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05). In addition, no significant difference was found for the subjective score of overall image quality and image noise level (SD) between the two groups (p > 0.05). However, significant differences was found in CTDI vol , DLP, and ED between the study group and the control group (p < 0.05). The effective dose of the study group was reduced by 76% compared to the control group.
CONCLUSION


CareDose 4D low-dose scanning combined with Karl 3D iterative reconstruction technology can not only greatly reduce the radiation dose, but also provide images that meet the diagnostic criteria of COVID-19, which can be used as a routine method for the follow-up of COVID-19 patients.",2020,"There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05).",['Sixty cases'],['CareDose 4D combined with Karl 3D technology'],"['CTDI vol , DLP, and ED', 'subjective score of overall image quality and image noise level (SD', 'value of CT measurement and its standard deviation (SD', 'low white blood cell counts and reduced lymphocyte ratios', 'apoptosis of peripheral blood lymphocytes', 'occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening', 'image quality', 'volume of CT dose index (CTDI vol ), dose length product (DLP) and effective dose (ED']","[{'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0085195', 'cui_str': 'Shadowing (Histology)'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0175715,"There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05).","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Fangxing', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Biochemistry and Molecular Biology, China Medical University, Shenyang, 110122, China.'}, {'ForeName': 'Guangzuo', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Institute of Translational Medicine, China Medical University, Shenyang, 110122, China. gzluo@cmu.edu.cn.'}, {'ForeName': 'Xunhua', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China. xxhwh@163.com.'}]",BMC medical imaging,['10.1186/s12880-020-00456-5']
2068,31813632,Effectiveness of two bed bath methods in removing microorganisms from hospitalized patients: A prospective randomized crossover study.,"BACKGROUND


Few studies have compared the effectiveness of washing with either soap and water or disposable wet wipes. The objective of this study was to compare the effectiveness of washing with either soap and water or disposable wet wipes in reducing microorganisms in the groin and perineum of hospitalized patients, which could potentially reduce the risk of hospital-acquired urinary tract infections.
METHODS


In this crossover, block-randomized trial, skin swabs from the groin and perineum areas of patients were obtained before and after these areas were washed with either soap and water or disposable wet wipes. Columbia agar plates and CHROMagar Orientation Medium (Becton Dickinson; Franklin Lakes, NJ) and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry procedures were used to identify species of microorganisms.
RESULTS


Fifty-eight paired skin swabs were obtained. Both washing methods resulted in a statistically significant reduction in the amount of all microorganisms, including microorganisms with the potential to cause urinary tract infections. New species were observed after using both washing methods. No statistically significant difference in the removal of microorganisms was observed between the two washing methods.
CONCLUSIONS


The two washing methods appear to be equally efficient in removal of microorganisms in the groin and perineum areas, including microorganisms that potentially could cause hospital-acquired urinary tract infections.",2020,"Both washing methods resulted in a statistically significant reduction in the amount of all microorganisms, including microorganisms with the potential to cause urinary tract infections.",['hospitalized patients'],['soap and water or disposable wet wipes'],['removal of microorganisms'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.0275957,"Both washing methods resulted in a statistically significant reduction in the amount of all microorganisms, including microorganisms with the potential to cause urinary tract infections.","[{'ForeName': 'Pia L', 'Initials': 'PL', 'LastName': 'Veje', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; University College South Denmark, Aabenraa, Denmark; Odense Patient Data Exploratory Network, Odense University Hospital, Odense, Denmark. Electronic address: pveje@health.sdu.dk.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; Hospital of Southern Jutland, University Hospital Southern Denmark, Aabenraa, Denmark; Department of Clinical Microbiology, Hospital of Southern Jutland, University Hospital of Southern Denmark, Soenderborg, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Jensen', 'Affiliation': 'National Center for Infection Control, Infectious Disease Epidemiology & Prevention, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Sørensen', 'Affiliation': 'Danish Centre for Health Economics, Department of Public Health, University of Southern Denmark, Odense, Denmark; Health Care Outcomes, Research Centre, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Primdahl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; Hospital of Southern Jutland, University Hospital Southern Denmark, Aabenraa, Denmark; Danish Hospital for Rheumatic Diseases, Soenderborg, Denmark.'}]",American journal of infection control,['10.1016/j.ajic.2019.10.011']
2069,31814522,"The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial.","Aims:  This study is aimed to investigate the effectiveness of an oral stimulation protocol in preterm infants compared to usual care, to reduce the time for achieving safe full oral feeding. Methods:  47 preterm infants (25- 30 weeks of gestational age) were randomized into two groups. Babies of the EG (n = 24) received a 10-minute oral stimulation protocol while the CG (n = 23) received the standard care. The primary outcome were the days from the initiation of the intervention until the achievement of full oral feeding. Secondary outcomes were: days from the first day the intervention started until achieving a first oral intake of 30% in the first 5 minutes, days from the first day the intervention started until achieving a first oral intake of 100%, and days of hospitalization. A parametric survival model with Gaussian distribution was used. Results:  The EG achieved full oral feeding 8.3 days before the CG (p = 0.013). EG also achieved the first oral intake of 30% in the first five minutes, 6.03 days before (p = 0.019) and of 100%, 5.88 days before (p = 0.040). EG also spent 6.9 days less hospitalized than CG (p = 0.028). Conclusion:  Oral stimulation in preterm infants significantly shortens the time to achieve full oral feeding and reduces the length of hospitalization.",2020,EG also spent 6.9 days less hospitalized than CG (p = 0.028).,"['Premature Infants', 'Babies of the EG (n = 24', 'preterm infants', '47 preterm infants (25- 30 weeks of gestational age']","['Oral Sensorimotor Stimulation Protocol', '10-minute oral stimulation protocol while the CG', 'oral stimulation protocol']","['intervention started until achieving a first oral intake of 100%, and days of hospitalization', 'time to achieve full oral feeding and reduces the length of hospitalization', 'intervention started until achieving a first oral intake', 'achievement of full oral feeding']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",47.0,0.0333618,EG also spent 6.9 days less hospitalized than CG (p = 0.028).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aguilar-Rodríguez', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'León-Castro', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez-Cerezo', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Aledón-Andújar', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Escrig-Fernández', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Josefina L', 'Initials': 'JL', 'LastName': 'Rodríguez de Dios-Benlloch', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás-Marín', 'Affiliation': 'Data Science, Biostatistics and Bioinformatics, Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Vento-Torres', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1698688']
2070,31819947,Evidence That Implementation Intentions Enhance Cognitive Training and Reduce Alcohol Consumption in Heavy Drinkers: A Randomized Trial.,"BACKGROUND


Current training tasks to improve the cognitive deficits thought to be involved in sustained heavy drinking need further investigation to optimize their effectiveness.
PURPOSE


The present study investigated whether combining implementation intention provision with a cognitive training task had a measurable effect on alcohol consumption in heavy drinkers and explored the neural mechanisms underpinning any reductions in subsequent alcohol consumption.
METHODS


Thirty-two heavy-drinking participants completed approach-avoidance and visual probe training tasks preintervention and postintervention during functional Magnetic Resonance Imaging. Participants in the intervention group were randomized to form implementation intentions and participants in the control condition read a goal intention. Alcohol consumption was recorded preintervention and at 1 month follow-up.
RESULTS


Compared to the control group, implementation intention provision significantly improved performance on alcohol-avoidance tasks postintervention, t(30) = -2.315, p = .028, d = .85, and reduced alcohol consumption by 6.9 units/week (1 unit = 10 mL or 8 g ethanol), F(1,30) = 4.263, p = .048 (d = .74), at follow-up. However, the analysis of functional Magnetic Resonance Imaging data revealed no significant differences between groups.
CONCLUSIONS


These findings show for the first time that implementation intentions targeting cognitive processes can significantly reduce alcohol consumption among heavy drinkers. However, there was no evidence that the effects were mediated by changes in neural activity. Further work is required to explore the neural mechanisms underpinning the operation of implementation intentions.
TRIAL REGISTRATION


This trial was registered (ISRCTN:35503634) and is available at https://www.isrctn.com/ISRCTN35503634.",2020,"Compared to the control group, implementation intention provision significantly improved performance on alcohol-avoidance tasks postintervention, t(30) =","['Heavy Drinkers', 'heavy drinkers', 'Thirty-two heavy-drinking participants completed']","['implementation intentions and participants in the control condition read a goal intention', 'cognitive training task', 'Implementation Intentions Enhance Cognitive Training', 'approach-avoidance and visual probe training tasks preintervention and postintervention during functional Magnetic Resonance Imaging']","['performance on alcohol-avoidance tasks postintervention, t(30) ', 'reduced alcohol consumption', 'neural activity', 'alcohol consumption', 'Alcohol consumption']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",32.0,0.098739,"Compared to the control group, implementation intention provision significantly improved performance on alcohol-avoidance tasks postintervention, t(30) =","[{'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Mcgrath', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Armitage', 'Affiliation': 'Manchester Centre for Health Psychology, Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Mckie', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Millar', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Asmuni', 'Initials': 'A', 'LastName': 'Ab-Ghani', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Rebecaa', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz056']
2071,31805802,Feasibility Study of a Therapeutic Mobility Summer Camp for Children with Severe Cerebral Palsy: Power Fun.,"Aim:  Powered mobility has positive effects on development of children with limited independent locomotion, but many are deprived of this opportunity due to their limitations. This study aimed to evaluate the feasibility of Power Fun, a therapeutic summer camp, for students with severe cerebral palsy (CP). Methods:  Five students with CP, ages 11-15, received personally adapted powered wheelchairs and participated daily in the camp. The camp ran five days a week during three weeks and included two mobility sessions daily. Assessments were conducted three weeks prior to the camp (T1), at baseline (T2), post-intervention (T3) and six weeks follow-up (T4). Measures used were Power Mobility Program (PMP), Assessment of Learning Power mobility use (ALP), Wheelchair Outcome Measure for Young People (WhOM-YP), Goal Attainment Scaling (GAS) and Dimensions of Mastery Questionnaire (DMQ). Results:  All participants finished the camp. Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test). Goals improved to slightly above the expected outcome (GAS average 0.11). Conclusions:  Power Fun shows good feasibility and significant improvement in mobility skills and goals of children with severe CP. Further studies are warranted.",2020,"Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test).","['children with severe CP', 'Children with Severe Cerebral Palsy', 'Five students with CP, ages 11-15, received personally adapted powered wheelchairs and participated daily in the camp', 'students with severe cerebral palsy (CP']",['Therapeutic Mobility Summer Camp'],"['Power Mobility Program (PMP), Assessment of Learning Power mobility use (ALP), Wheelchair Outcome Measure for Young People (WhOM-YP), Goal Attainment Scaling (GAS) and Dimensions of Mastery Questionnaire (DMQ', 'mobility skills and goals']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2092170', 'cui_str': 'Motorized wheelchair device'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",5.0,0.0248582,"Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Maeir', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Gilboa', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1695699']
2072,32448171,Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial.,"BACKGROUND


Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC) rely on a limited number of therapeutic agents resulting in a median survival of 2-3 years. A subgroup of those patients with mCRPC presents with oligoprogressive disease, with a limited number of progressive lesions while other metastases are still controlled by ongoing systemic treatment.
METHODS


In this single arm prospective phase II trial, we aim to include 18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions. Progression is based on conventional imaging, as the use of PSMA PET-CT is considered investigational. However all patients will undergo PSMA PET-CT and the images will be blinded until progression. Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT. Recruitment of patients for this trial started in January 2020 and will be completed approximately by December 2020.
DISCUSSION


In this phase 2 trial on oligoprogressive mCRPC, we will investigate the benefit of progression-directed therapy while continuing ongoing systemic treatment. We hypothesize that progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy for these oligoprogressive lesions will postpone the start of next-line systemic treatment and therefore serve as a new or add-on therapy in the spectrum of treatments available for mCRPC. The results of this trial will serve as guidance for a later randomized phase 3 trial. All participants are given an information sheet and are required to give written informed consent. Results will be published in a peer-reviewed journal.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov: NCT04222634 (December 18th 2019).",2020,Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT.,"['Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC', 'castration-refractory prostate cancer (MEDCARE', '18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions']","['progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy', 'Metastasis-directed therapy']",['postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",18.0,0.190845,Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT.,"[{'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Berghen', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium. charlien.berghen@uzleuven.be.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kato', 'Initials': 'K', 'LastName': 'Rans', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Poels', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Slabbaert', 'Affiliation': 'Department of Urology, RZ Tienen, Tienen, Belgium.'}, {'ForeName': 'Herlinde', 'Initials': 'H', 'LastName': 'Dumez', 'Affiliation': 'Department of Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Albersen', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'Goffin', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Meerleer', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}]",BMC cancer,['10.1186/s12885-020-06853-x']
2073,32448177,"The effect of high dietary fiber intake on gestational weight gain, fat accrual, and postpartum weight retention: a randomized clinical trial.","BACKGROUND


Interventions to prevent excessive gestational weight gain (GWG) have had limited success This pilot study examined the effectiveness of a single goal (SG) high dietary fiber intervention to prevent excessive GWG.
METHODS


Twelve weekly lessons focused on consuming a high fiber diet (≥30 g/day). Snacks containing 10-12 g of dietary fiber were given for the first 6 weeks only. Body composition was measured at baseline and at the end of the intervention. At one-year postpartum, body weight retention and dietary practices were assessed. A p-value is reported for the primary analysis only. For all other comparisons, Cohen's d is reported to indicate effect size.
RESULTS


The SG group increased fiber intake during the study (32 g/day at 6 weeks, 27 g/day at 12 weeks), whereas the UC group did not (~ 17 g/day). No differences were found for the proportion of women classified as excessive gainers (p = 0.13). During the intervention, the SG group gained less body weight (- 4.1 kg) and less fat mass (- 2.8 kg) (d = 1.3). At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
CONCLUSION


The SG intervention resulted in less weight gain, fat accrual, and weight retention at 1 year postpartum. A residual intervention effect was detected postpartum with the participants reporting continued efforts to consume a high fiber diet.
TRIAL REGISTRATION


NCT03984630; Trial registered June 13, 2019 (retrospectively registered).",2020,"At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
",[],"['single goal (SG) high dietary fiber intervention', 'SG intervention', 'high dietary fiber intake']","['weight gain, fat accrual, and weight retention', 'gestational weight gain, fat accrual, and postpartum weight retention', 'weight', 'Body composition', 'body weight', 'excessive gestational weight gain (GWG', 'fat mass', 'proportion of women classified as excessive gainers', 'fiber intake', 'body weight retention and dietary practices']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0745225,"At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
","[{'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA. hhull@kumc.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gibbs', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Krase', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Kansas Hospital, Kansas City, KS, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Goetz', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03016-5']
2074,32448187,"A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study.","BACKGROUND


Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
METHODS


The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19-1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
DISCUSSION


Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families.
TRIAL REGISTRATION


Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.",2020,"By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
","['One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada', 'Registered September 23, 2019 on Clinicaltrials.gov', 'critically ill adults', 'Critically ill patients', 'critically ill patients on family member symptoms of depression and anxiety, compared to usual care', 'critically ill patients admitted to the intensive care unit (ICU']",[],"['Delirium, depression, and anxiety']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.100765,"By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
","[{'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada. kmfiest@ucalgary.ca.'}, {'ForeName': 'Karla D', 'Initials': 'KD', 'LastName': 'Krewulak', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Bonnie G', 'Initials': 'BG', 'LastName': 'Sept', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Spence', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry, UC San Diego School of Medicine, San Diego, California, USA.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': ""Tennessee Valley Veteran's Affairs Geriatric Research Education Clinical Center (VA GRECC), Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Soo', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}]",BMC health services research,['10.1186/s12913-020-05281-8']
2075,32448257,"A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt.","BACKGROUND


Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed.
METHODS


This cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions.
RESULTS


Misoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
CONCLUSIONS


Misoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02226588, date of registration 27 August 2014.",2020,"There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
","['women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt', 'postpartum hemorrhage among community level births in Egypt']","['Misoprostol', 'sublingual misoprostol', 'misoprostol']","['mean drop in pre- to post-delivery hemoglobin', 'hemoglobin drop ≥2\u2009g/dL, PPH diagnosis, transfer to higher level, or other interventions', 'mean change in pre- and post-delivery hemoglobin', 'hemoglobin ≥2\u2009g/dL and other PPH interventions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028655', 'cui_str': 'Nurse-Midwife'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.355977,"There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
","[{'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Anger', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA. hanger@gynuity.org.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Dabash', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}, {'ForeName': 'Nevine', 'Initials': 'N', 'LastName': 'Hassanein', 'Affiliation': 'Independent Reproductive Health Consultant, Cairo, Egypt.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Darwish', 'Affiliation': 'Faculty of Medicine, Alexandria University, 17 Champollion St, El Messalah, Alexandria, Egypt.'}, {'ForeName': 'Mohamed Cherine', 'Initials': 'MC', 'LastName': 'Ramadan', 'Affiliation': 'Department of Obstetrics and Gynecology, El Galaa Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Nawar', 'Affiliation': 'El Beheira Governorate, Ministry of Health and Population, Damanhour, Egypt.'}, {'ForeName': 'Dyanna', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}, {'ForeName': 'Miral', 'Initials': 'M', 'LastName': 'Breebaart', 'Affiliation': 'Independent Public Health Consultant, Cairo, Egypt.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03008-5']
2076,32448299,Acceptability and feasibility of a behavioral and mobile health intervention (COMBIND) shown to increase uptake of prevention of mother to child transmission (PMTCT) care in India.,"BACKGROUND


A cluster-randomized trial recently demonstrated that an integrated behavioral and mobile technology intervention improved uptake of key components of a Prevention of Mother to Child Transmission (PMTCT) Option B+ program, among HIV- infected pregnant/breastfeeding women in India. To guide scale-up and optimize programmatic implementation, we conducted a mixed-methods evaluation of the feasibility and acceptability of this intervention.
METHODS


The COMmunity Home Based INDia (COMBIND) study, was conducted in four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs. This qualitative evaluation was done through 15 in-depth interviews (IDIs) with ORWs and 15 IDIs with HIV-infected pregnant/breastfeeding women from the intervention arm. Utilizing a concurrent nested mixed-method evaluation approach, we assess the feasibility and acceptability of the study intervention.
RESULTS


All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices. A majority of the ORWs reported that the personal empowerment training with motivational interviewing skills training increased their confidence, motivation and gave them the tools for effectively supporting their clients. The mHealth application improved their working style as it facilitated targeted PMTCT information support, systemized data capture, streamlined their health education delivery practice and provided a sense of work satisfaction. The SMS appointment alerts improved retention in HIV care for mother and baby to the smaller proportion that had access to their phones. Despite reported improvements in knowledge and communication, few ORWs reported that structural challenges such as limited drug stocks, lack of HIV kits or unavailability of trained staff at ICTC, may hamper the uptake of PMTCT services, thus resulting in limited significant impacts of COMBIND on PMTCT outcomes.
CONCLUSION


This study found that COMBIND intervention is scalable, feasible, beneficial and very well accepted by ORWs and patients, however structural challenges in goods and services remain.",2020,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"['mother to child transmission (PMTCT) care in India', 'Mother to Child Transmission (PMTCT', 'four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the', 'HIV- infected pregnant/breastfeeding women in India', 'The COMmunity Home Based INDia']","['COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs', 'behavioral and mobile health intervention (COMBIND']","['feasibility and acceptability', 'retention in HIV care']","[{'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",119.0,0.0351705,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"[{'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India. nishisuryavanshi@hotmail.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kadam', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bollinger', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-020-08706-5']
2077,32448331,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial.","BACKGROUND


Disruptive behavior in hospitalized patients has become a priority area of safety concern for clinical staff, and also has consequences for patient management and hospital course. Proactive screening and intervention of patients with behavioral comorbidities has been reported to reduce disruptive behavior in some settings, but it has not been studied in a rigorous way.
METHODS


The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted. Each month, the behavioral intervention team, comprising a psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA. The team proactively screens patients upon admission, utilizing a protocol which includes a comprehensive chart review and, if indicated, a brief interview, seeking to identify those patients who possess risk factors indicative of either a potential psychological barrier to their own clinical progress or a potential risk for exhibiting disruptive, aggressive, or self-injurious behavior during their hospitalization. Once identified, the team provides interventions aimed at mitigating these risks, educates and supports the patient care teams (nurses, physicians, and others), and assists non-psychiatric staff in the management of patients who require behavioral healthcare. Patients who are both admitted to and discharged from either unit are included in the study. Anticipated enrollment is approximately 1790 patients. The two primary outcomes are (1) a composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior. Secondary outcomes include patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention.
DISCUSSION


This ongoing trial will provide evidence on the real-world effectiveness of a proactive behavioral intervention to prevent disruptive, threatening, or acting out events in adult hospitalized patients.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03777241. Registered on 14 December 2018.",2020,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted.","['1790 patients', 'patients with behavioral comorbidities', 'hospitalized patients', 'adult hospitalized patients', 'psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA', 'patients who require behavioral healthcare', 'Patients who are both admitted to and discharged from either unit are included in the study']","['Proactive screening and intervention', 'proactive behavioral intervention']","['patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention', ""composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001241', 'cui_str': 'Acting out - mental defense mechanism'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",,0.0502974,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hasselblad', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kleinpell', 'Affiliation': 'Vanderbilt University School of Nursing, 461 21st Ave, 407 GH, Nashville, TN, 37240, USA. ruth.kleinpell@vanderbilt.edu.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Buie', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ariosto', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hardiman', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Osborn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics and Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04278-2']
2078,32448335,Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial.,"BACKGROUND


The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Apatinib mesylate also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby strongly inhibiting tumor angiogenesis and exerting an anti-tumor effect. However, there have been no reports of a randomized controlled clinical trial of apatinib combined with vinorelbine for the treatment of triple-negative breast cancer (TNBC). We will compare the therapeutic effect of vinorelbine alone or in combination with apatinib mesylate, in patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments, including anthracyclines and taxanes.
METHODS/ANALYSIS


This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 238 female patients with locally recurrent or metastatic TNBC, admitted to the Liaoning Cancer Hospital & Institute, Northeast China. All enrolled patients will be randomized to oral vinorelbine alone (40 mg, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle), or in combination with oral apatinib mesylate (500 mg, once daily in each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks and every 9 weeks thereafter. The primary outcome is progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4, as defined by the National Cancer Institute Common Toxicity Criteria Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation.
DISCUSSION


Based on the data from this trial, we hope to identify a treatment plan that is suitable for female patients with TNBC, who have been treated with anthracyclines and taxanes, in Northeast China.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03932526. Registered on 30 April 2019.",2020,"Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase.","['238 female patients with locally recurrent or metastatic TNBC, admitted to the Liaoning Cancer Hospital & Institute, Northeast China', 'female patients with TNBC, who have been treated with anthracyclines and taxanes, in Northeast China', 'advanced breast cancer', 'recurrent or metastatic triple-negative breast cancer', 'patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments, including anthracyclines and taxanes', 'triple-negative breast cancer (TNBC']","['vinorelbine', 'oral vinorelbine alone', 'vinorelbine alone', 'vinorelbine alone or in combination with apatinib mesylate', 'apatinib mesylate and vinorelbine', 'oral apatinib mesylate', 'placebo']","['progression-free survival', 'overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4, as defined by the National Cancer Institute Common Toxicity Criteria Version 4.0']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4547969', 'cui_str': 'apatinib mesylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",238.0,0.175538,"Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Junnan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China. jianong@126.com.'}]",Trials,['10.1186/s13063-020-04342-x']
2079,32448345,"Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial.","BACKGROUND


Coronavirus disease 2019 (COVID-19), caused by a novel corinavirus (later named SARS-CoV-2 virus), was fistly reported in Wuhan, Hubei Province, China towards the end of 2019. Large-scale spread within China and internationally led the World Health Organization to declare a Public Health Emergency of International Concern on 30 th  January 2020. The clinical manifestations of COVID-19 virus infection include asymptomatic infection, mild upper respiratory symptoms, severe viral pneumonia with respiratory failure, and even death. There are no antivirals of proven clinical efficacy in coronavirus infections. Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments. It is also inhibitory against the COVID-19 virus in vitro. The aim of this study is to assess the efficacy and safety of remdesivir in adult patients with severe COVID-19.
METHODS


The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. This is a phase 3, randomized, double-blind, placebo-controlled, multicentre trial. Adults (≥ 18 years) with laboratory-confirmed COVID-19 virus infection, severe pneumonia signs or symptoms, and radiologically confirmed severe pneumonia are randomly assigned in a 2:1 ratio to intravenously administered remdesivir or placebo for 10 days. The primary endpoint is time to clinical improvement (censored at day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 = discharged; 6 = death) or live discharge from hospital. One interim analysis for efficacy and futility will be conducted once half of the total number of events required has been observed.
DISCUSSION


This is the first randomized, placebo-controlled trial in COVID-19. Enrolment began in sites in Wuhan, Hubei Province, China on 6 th  February 2020.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04257656. Registered on 6 February 2020.",2020,"Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments.","['Adults (≥\u200918 years) with laboratory-confirmed COVID-19 virus infection, severe pneumonia signs or symptoms, and radiologically confirmed severe pneumonia', 'adult patients with severe COVID-19', 'Enrolment began in sites in Wuhan, Hubei Province, China on 6 th  February 2020']","['remdesivir or placebo', 'intravenous remdesivir', 'placebo']","['efficacy and safety', 'efficacy and safety of remdesivir', 'time to clinical improvement', 'six-category ordinal scale of clinical status (1 = discharged; 6 = death) or live discharge from hospital']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}]",,0.699402,"Remdesivir (GS-5734), a nucleoside analogue, has inhibitory effects on animal and human highly pathogenic coronaviruses, including MERS-CoV and SARS-CoV, in in vitro and in vivo experiments.","[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei Province, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Medicine, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Medicine, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Medicine, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei Province, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei Province, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei Province, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'ISARIC, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China. caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China. cyh-birm@263.net.'}]",Trials,['10.1186/s13063-020-04352-9']
2080,32448358,A randomized controlled study of immediate versus delayed umbilical cord clamping in infants born by elective caesarean section.,"BACKGROUND


Delayed umbilical cord clamping is associated with greater haemoglobin concentration and iron storage between 3 and 6 months of life and with less need of blood transfusion and lower incidence of neonatal hypotension compared to early umbilical cord clamping.
METHODS


The aim was to test the hypothesis that delayed cord clamping is better than early cord clamping in term infants born by elective caesarean section. Group A was subjected to immediate cord clamping while in the Group B, the umbilical cord was clamped 1 min after birth. Primary aim was revealed the difference in pre-ductal saturation between two groups while secondary aim was investigating the difference in HR, Ht, bilirubin and glycaemia. Pre-ductal SpO 2  and HR were recorded at 5 and 10 min after birth, T was analysed 10 min after birth, glycaemia was revealed at 120 min while Ht and bilirubin were collected at 72 h.
RESULTS


132 newborns were enrolled in the study and allocated in ratio 1:1 to group A or B. Delayed cord clamping did not improve SpO 2,  HR and T values compared to immediate cord clamping (p > 0,05). However, Group B showed greater haematocrit and bilirubin values at 72 h compared to Group A (56,71 ± 6663 vs 51,56 ± 6929; p < 0,05 and 8,54 ± 2,90 vs 7,06 ± 2,76; p < 0,05). Glycaemia value did not differ between two groups (p > 0,05).
CONCLUSIONS


Group B did not reveal any differences in SpO 2 , HR, T and glycaemia compared to Group A. Group B showed greater values of haematocrit and bilirubin but without need of phototherapy.
TRIAL REGISTRATION


Umbilical Cord Clamping: What Are the Benefits; NCT03878602. Registered 18 March 2019 retrospectively registered.",2020,"Glycaemia value did not differ between two groups (p > 0,05).
","['infants born by elective caesarean section', 'term infants born by elective caesarean section', '132 newborns']","['Umbilical Cord Clamping', 'immediate versus delayed umbilical cord clamping']","['HR, Ht, bilirubin and glycaemia', 'haematocrit and bilirubin values', 'SpO 2 , HR, T and glycaemia', 'haemoglobin concentration and iron storage', 'pre-ductal saturation', 'Glycaemia value', 'ductal SpO 2  and HR', 'haematocrit and bilirubin', 'neonatal hypotension']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272667', 'cui_str': 'Born by elective cesarean section'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0455995', 'cui_str': 'Neonatal hypotension'}]",132.0,0.146248,"Glycaemia value did not differ between two groups (p > 0,05).
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Bernardo', 'Affiliation': 'Division of Pediatrics Neonatology and NICU, Ospedale Buon Consiglio Fatebenefratelli, Via Manzoni 220, 80123, Naples, Italy. pinodebtin@gmail.com.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Giordano', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'De Santis', 'Affiliation': 'School of specialization in Pediatrics, Catholic University of the Sacred Heart Faculty of Medicine and Surgery, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Castelli', 'Affiliation': 'School of specialization in Pediatrics, University of Pavia Faculty of Medicine and Surgery, Pavia, Italy.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Sordino', 'Affiliation': 'Department of Emergency-NICU, A.O.R.N. Santobono-Pausilipon, Naples, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Woman's and Child's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Buonocore', 'Affiliation': 'Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Serafina', 'Initials': 'S', 'LastName': 'Perrone', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",Italian journal of pediatrics,['10.1186/s13052-020-00835-2']
2081,32448374,REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial.,"BACKGROUND


Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30-50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6-8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate.
METHODS


Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices.
SETTING


England and north Wales.
POPULATION


patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use.
INTERVENTION


provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation.
OUTCOME MEASURES


the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms.
SECONDARY OUTCOMES


depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs.
SAMPLE SIZE


402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15-20 patients and 15-20 practitioners in each arm to explore why the interventions were effective or not, depending on the results.
DISCUSSION


Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
TRIAL REGISTRATION


ISRCTN:12417565. Registered on 7 October 2019.",2020,"If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
","['402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18\u2009months, and followed-up at 3, 6, 9 and 12\u2009months', 'England and north Wales', 'interviews with 15-20 patients and 15-20 practitioners', 'patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use']","[""provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner""]","['self-reported nine-item Patient Health Questionnaire at 6\u2009months for depressive symptoms', 'depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.115424,"If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
","[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK. A.R.Kendrick@soton.ac.uk.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bowers', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Leydon', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': ""O'Brien"", 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Glowacka', 'Affiliation': 'Department for Rehabilitation and Sport Sciences, Faculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Holley', 'Affiliation': 'School of Psychology, Building 44 Highfield Campus, University of Southampton, Southampton, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dewar-Haggart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Palmer', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Collinson', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Fry', 'Affiliation': 'School of Psychology, Building 44 Highfield Campus, University of Southampton, Southampton, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, Seebohm Rowntree Building, University of York, York, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moncrieff', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Macleod', 'Affiliation': 'Hull York Medical School, Allam Medical Building, University of Hull, Hull, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dowrick', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.'}]",Trials,['10.1186/s13063-020-04338-7']
2082,32448382,"Biphasic human insulin 30 thrice daily, is it reasonable?","OBJECTIVE


To evaluate the efficacy and safety of thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen in type 2 diabetes mellitus (T2DM) patients. It's a cross over single clinical study. Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included. At the 1st interval; patients continued on their usual insulin regimen as twice or thrice daily injections with adjustment of insulin doses guided by their glucose readings. On the 2nd interval; patients were switched to the other regimen with the same total daily insulin dose redistributed.
RESULTS


There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05. On the other hand, patients had lower average blood glucose readings (mg/dl) when they were on thrice daily insulin injections (161.4 ± 62.7) compared to twice daily regimen (166.0 ± 69.5), p < 0.05.",2020,"There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05.","['type 2 diabetes mellitus (T2DM) patients', 'Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included']",['thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen'],"['efficacy and safety', 'average blood glucose readings', 'HbA1c level', 'mean HbA1c reduction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3501748', 'cui_str': 'biphasic human insulin 30'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3501748', 'cui_str': 'biphasic human insulin 30'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",22.0,0.0189197,"There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05.","[{'ForeName': 'Nesreen A', 'Initials': 'NA', 'LastName': 'Saadeh', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, P.O.Box 3030, Irbid, 22110, Jordan. nasaadeh@just.edu.jo.'}, {'ForeName': 'Ola Y', 'Initials': 'OY', 'LastName': 'Al-Azzeh', 'Affiliation': 'Pharmacy Practice Department, College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Community Medicine, Public Health and Family Medicine, Faculty of Medicine, Jordan University of Science & Technology, Irbid, Jordan.'}]",BMC research notes,['10.1186/s13104-020-05090-6']
2083,32448384,Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study.,"BACKGROUND


Iliotibial band syndrome (ITBS) carries marked morbidity in runners. Its management is not standardized and lacks evidence base. We evaluated the effectiveness of three different exercises programs in reducing ITBS symptoms.
METHODS


Patients were divided into three equal treatment groups: ITB stretching (group A), conventional exercise (group B), and experimental hip strengthening exercise (group C). Numeric pain rating scale (NPRS; every week), lower extremity functional scale (LEFS; every 2 weeks), dynamometer (DN; weeks 0, 2, 4, 6, 8), single-limb mini squat (SLMS; week 0, 8), and Y-balance test™ (YBT), between and within group's differences were evaluated using ANOVA model.
RESULTS


Twenty-four female runners (age 19-45 years) were included into one of three groups (A, B, and C). Statistical significance (p < 0.05) within group C was observed for composite YBT and DN for injured and non-injured leg, the YBT (injured leg for the posterior medial), LEFS, NPRS, and the SLMS. Statistical significance (p < 0.05) was found between group A and group C. The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
CONCLUSION


There were no statistical differences between the three groups. The subjects who underwent experimental hip strengthening exercises consistently showed improvements in outcome measures, and never scored less than the other two groups.
TRIAL REGISTRATION


ClinicalTrials.gov identifier (NCT number): NCT0229615.",2020,"The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
","['runners', 'Twenty-four female runners (age 19-45 years', 'Patients', 'female runners']","['ITB stretching', 'Iliotibial band syndrome rehabilitation', 'conventional exercise (group B), and experimental hip strengthening exercise', 'experimental hip strengthening exercises']","['ITBS symptoms', 'Numeric pain rating scale (NPRS; every week), lower extremity functional scale (LEFS; every 2 weeks), dynamometer (DN; weeks 0, 2, 4, 6, 8), single-limb mini squat (SLMS; week 0, 8), and Y-balance test™ (YBT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0263843', 'cui_str': 'Snapping hip'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0263843', 'cui_str': 'Snapping hip'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0207973,"The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
","[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'McKay', 'Affiliation': 'Emirates Integra Medical and Surgery Centre, Dubai, UAE.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Salerno, Italy. n.maffulli@qmul.ac.uk.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Aicale', 'Affiliation': 'Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Salerno, Italy.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Taunton', 'Affiliation': 'Allan McGavin Sports Medicine Centre, Vancouver, BC, Canada.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01713-7']
2084,32448387,The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.,"BACKGROUND


Chronic pain is highly prevalent in the working population. People tend to attempt self-initiated treatments to manage their pain. The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain). The aim in this study is to develop ePain and to evaluate its effectiveness at improving pain self-efficacy, reducing pain intensity and negative emotions, and increasing quality of life.
METHODS


This study will be a randomized controlled trial. ePain will take the form of a 6-week online pain management programme. Participants will be aged 15 years or above, have chronic pain, and be employed. They must complete the baseline questionnaire and will be randomized into intervention and control groups. They will receive notifications to encourage their participation in ePain and complete the evaluation questionnaires. They will complete the process evaluation at week 3, the post assessment at week 6, and the follow-up assessment at week 12. The study will focus on pain self-efficacy; pain situations; negative emotions including levels of depression, anxiety, and stress; and quality of life. The participants' opinions of ePain will be collected as feedback. Data will be analysed on an intention-to-treat basis and generalized estimating equations will be used to investigate the time-averaged difference and differences at each follow-up time.
DISCUSSION


The study will provide information about the pain situations of online users in the working population. The participants will benefit from improvements in pain self-efficacy, pain situations, emotional status, and quality of life. The study will illustrate whether online learning is an effective intervention for improving the pain self-efficacy of the working population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03718702. Registered on 23 October 2018.",2020,The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain).,"['working population with chronic pain', 'Participants will be aged 15\xa0years or above, have chronic pain, and be employed']","['electronic pain management programme', 'online learning']","['quality of life', 'pain self-efficacy, pain situations, emotional status, and quality of life', 'pain self-efficacy, reducing pain intensity and negative emotions', 'pain self-efficacy', 'depression, anxiety, and stress; and quality of life']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.151,The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain).,"[{'ForeName': 'Shuk Kwan', 'Initials': 'SK', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong. skangel.tang@connect.polyu.hk.'}, {'ForeName': 'Mimi Mun Yee', 'Initials': 'MMY', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Sau Fong', 'Initials': 'SF', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Theofanis', 'Initials': 'T', 'LastName': 'Fotis', 'Affiliation': 'School of Health Sciences, University of Brighton, Westlain House, Village Way, Brighton, BN1 9PH, UK.'}]",Trials,['10.1186/s13063-020-04348-5']
2085,32448392,Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study.,"BACKGROUND


In two recent randomized controlled trials, withholding parenteral nutrition early in critical illness improved outcome as compared to early up-to-calculated-target nutrition, which may be explained by beneficial effects of fasting. Outside critical care, fasting-mimicking diets were found to maintain fasting-induced benefits while avoiding prolonged starvation. It is unclear whether critically ill patients can develop a fasting response after a short-term nutrient interruption. In this randomized crossover pilot study, we investigated whether 12-h nutrient interruption initiates a metabolic fasting response in prolonged critically ill patients. As a secondary objective, we studied the feasibility of monitoring autophagy in blood samples.
METHODS


In a single-center study in 70 prolonged critically ill patients, 12-h up-to-calculated-target feeding was alternated with 12-h fasting on day 8 ± 1 in ICU, in random order. Blood samples were obtained at the start of the study, at the crossover point, and at the end of the 24-h study period. Primary endpoints were a fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia. Secondary outcomes included serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells. To obtain a healthy reference, mRNA and protein markers of autophagy were assessed in whole blood and isolated white blood cells of 23 matched healthy subjects in fed and fasted conditions. Data were analyzed using repeated-measures ANOVA, Fisher's exact test, or Mann-Whitney U test, as appropriate.
RESULTS


A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF-I (all p ≤ 0.001). Urea was not affected. BOH was already increased from 4 h fasting onwards. Autophagic markers in blood samples were largely unaffected by fasting in patients and healthy subjects.
CONCLUSIONS


A 12-h nutrient interruption initiated a metabolic fasting response in prolonged critically ill patients, which opens perspectives for the development of a fasting-mimicking diet. Blood samples may not be a good readout of autophagy at the tissue level.
TRIAL REGISTRATION


ISRCTN, ISRCTN98404761. Registered 3 May 2017.",2020,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"['patients and healthy subjects', 'critically ill patients', '23 matched healthy subjects in fed and fasted conditions', 'prolonged critically ill patients', '70 prolonged critically ill patients']",['12-h nutrient interruption'],"['metabolic fasting response', 'serum bilirubin and BOH and decreased insulin requirements and serum IGF', 'fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia', 'BOH', 'Urea', 'serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",70.0,0.0616562,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilmer', 'Affiliation': 'Medical Intensive Care Unit, Department of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Schrijvers', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gunst', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Michaël P', 'Initials': 'MP', 'LastName': 'Casaer', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium. michael.casaer@uzleuven.be.'}]","Critical care (London, England)",['10.1186/s13054-020-02987-3']
2086,32448401,"Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study.","BACKGROUND


Subacute thyroiditis (SAT) is the most common cause of thyroid pain. Several clinical guidelines recommend that patients who fail to respond to full doses of non-steroidal anti-inflammatory drugs (NSAIDs) should be treated instead with oral corticosteroid therapy. However, albeit strong recommendations, the treatment protocol is based on low-quality evidence and high-quality clinical trials are lacking with respect to the optimal initiation dosage and usage of corticosteroid. We aimed to evaluate whether 15 mg/day of prednisolone (PSL) as the initial dosage could provide non-inferiority effectiveness but with lower risk and more safety compared with 30 mg/day of PSL as the initial dosage.
METHODS/DESIGN


This is a multicenter, open-label, randomized, parallel trial that will be conducted at five academic hospitals in China. A total of 90 adult patients diagnosed with SAT who present moderate to severe pain or fail to respond to full doses of NSAIDs will be randomly assigned with a 1:1 ratio to the low initial PSL dosage group (15 mg daily) and standard initial PSL dosage group (30 mg daily). The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
DISCUSSION


Our randomized controlled trial will try to determine the optimal protocol in the treatment of SAT by providing high-quality evidence.
TRIALS REGISTRATION


Chinese Clinical Trial Register, ChiCTR1900023884. Registered on 15 June 2019.",2020,"The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
","['patients with subacute thyroiditis', 'patients who fail to respond to full doses of non-steroidal anti-inflammatory drugs (NSAIDs', 'five academic hospitals in China', '90 adult patients diagnosed with SAT who present moderate to severe pain or fail to respond to full doses of NSAIDs']","['prednisolone', 'prednisolone (PSL']",['time period (days) required for PSL treatment (including PSL treatment for recurrence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",90.0,0.143143,"The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
","[{'ForeName': 'Shaoyong', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Clinical Medicine, Medical College of Yan'an University, No. 38, Guanghua Road, Yan'an, 716000, China.""}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Jia', 'Affiliation': 'Department of Endocrinology, No.1 Hospital of Yulin, Yulin, 719000, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, 3201 Hospital of Xi'an Jiao tong University Health Science Center, 783 Tianhan Road, Hanzhong, Shaanxi, 723000, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': ""Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Wenlei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China.'}, {'ForeName': 'Ruikun', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China. linggao048@sina.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China. shanglei@fmmu.edu.cn.""}]",Trials,['10.1186/s13063-020-04337-8']
2087,32448552,Randomized Trial of a Physical Activity Intervention for Latino Men: Activo.,"INTRODUCTION


Latino men experience disproportionately high rates of diseases related to low physical activity, yet they are poorly represented in physical activity intervention trials. Efforts to promote physical activity in Latina women show promising results, yet such interventions are yet to be extended to Latino men. This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time. Potential predictors of intervention success were also explored.
STUDY DESIGN


Randomized trial. Participants were randomized to receive a Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control). Data were collected in 2015-2017 and analyzed in 2018-2019.
SETTING/PARTICIPANTS


Insufficiently active Latino men (n=46).
INTERVENTION


Intervention participants received a baseline counseling session and then, individually tailored print materials and text messages on a tapered schedule for 6 months. Control participants received printed wellness materials and text messages on the same schedule.
MAIN OUTCOME MEASURES


Primary outcome was a change in weekly moderate to vigorous physical activity from baseline to 6 months measured by accelerometers. Self-reported moderate to vigorous physical activity measured by the 7-day Physical Activity Recall Interview was a secondary outcome.
RESULTS


For Intervention participants, median accelerometer-measured moderate to vigorous physical activity increased from 10.0 minutes/week at baseline to 57.5 minutes/week at 6 months, whereas for Control participants, it increased from 21.0 minutes/week at baseline to 23.0 minutes/week at 6 months (p<0.05). Similar results were found for self-reported moderate to vigorous physical activity. At 6 months, 47% of Intervention participants met national guidelines of 150 minutes/week versus 25% of Control participants (p=0.15, not significant).
CONCLUSIONS


Findings suggest that an individually tailored intervention can successfully increase moderate to vigorous physical activity in underactive Latino men. Such technology-supported interventions have the potential for broad dissemination.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02512419.",2020,"This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time.","['Insufficiently active Latino men (n=46', 'underactive Spanish-speaking Latino men', 'Latina women', 'Latino Men', 'underactive Latino men', 'Data were collected in 2015-2017 and analyzed in 2018-2019']","['Intervention participants received a baseline counseling session', 'Physical Activity Intervention', 'computer expert system‒tailored, text messaging-supported physical activity intervention', 'Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control', 'printed wellness materials and text messages']","['vigorous physical activity', 'median accelerometer-measured moderate to vigorous physical activity', '7-day Physical Activity Recall Interview', 'change in weekly moderate to vigorous physical activity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0391853', 'cui_str': 'Underactive'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.0298802,"This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time.","[{'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California. Electronic address: blarsen@ucsd.edu.'}, {'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, Department of Psychiatry and Human Behavior, Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Jesse N', 'Initials': 'JN', 'LastName': 'Nodora', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island; Department of Human Development and Family Studies, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.007']
2088,32448624,"Infant antibody levels following 10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations in the first year of life after maternal Tdap vaccination: An open-label, parallel, randomised controlled trial.","BACKGROUND


Maternal antibody levels after Tdap vaccination during pregnancy may affect infant primary antibody responses to pertussis, Tetanus toxoid (TT), Diphtheria toxoid (DT) vaccinations and pneumococcal vaccines with diphtheria toxin mutants like CRM197 as carrier protein.
METHODS


Mothers were recruited in an open label randomised parallel controlled trial in 2014-2016 through midwifes. They received Tdap [Boostrix] at 30-32 weeks of pregnancy (n = 58) or within 48 h after delivery (n = 60). Infants received DTaP-IPV-Hib-HepB [Infanrix Hexa] and 10-valent protein D conjugated pneumococcal conjugate vaccine (PHiD-CV10 [Synflorix]) at age 3, 5 and 11 months. We now report on infant specific IgG levels towards DT, TT, Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP) and PHiD-CV10 before and after primary- and booster vaccination as secondary study endpoints; pertussis antibodies were the primary endpoint of the study. This trial is registered in clinicaltrialsregister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314).
FINDINGS


Post primary vaccinations, antibody levels to DT, but not TT, were significantly lower after Tdap vaccination during pregnancy compared to controls (GMC ratio 0.4, 95% CI 0.3-0.6 and 0.9, 95% CI 0.6-1.2, respectively). Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes. Post booster vaccinations, no significant differences were observed, except for DT.
INTERPRETATION


Maternal Tdap vaccination results in significant interference with infants responses not only to DT but also to conjugated pneumococcal vaccines containing DT mutants as carrier proteins. These interactions after maternal Tdap vaccination need to be taken into account when designing infants' national immunization schedules and choice of vaccines.
FUNDING


The Dutch Ministry of Health, Welfare and Sport.",2020,"Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes.","['life after maternal Tdap vaccination', 'Mothers were recruited in an open label randomised parallel controlled trial in 2014-2016 through midwifes']","['10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations', 'Tdap [Boostrix', 'DTaP-IPV-Hib-HepB [Infanrix Hexa] and 10-valent protein D conjugated pneumococcal conjugate vaccine (PHiD-CV10 [Synflorix', 'Tetanus toxoid (TT), Diphtheria toxoid (DT) vaccinations']","['Antibodies to serotype 19F', 'antibody levels to DT', 'antibody levels', 'Infant antibody levels']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0018482', 'cui_str': 'Haemophilus infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1613021', 'cui_str': 'Boostrix'}, {'cui': 'C2716397', 'cui_str': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}, {'cui': 'C3661302', 'cui_str': 'Infanrix hexa'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.129252,"Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, the Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Kuijer', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, the Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",Vaccine,['10.1016/j.vaccine.2020.04.001']
2089,32448677,"Auditory versus visual neuroscience-informed cognitive training in schizophrenia: Effects on cognition, symptoms and quality of life.","BACKGROUND


Cognitive impairments are related to deficits in primary auditory and visual sensory processes in schizophrenia. These impairments can be remediated by neuroscience-informed computerized cognitive trainings that target auditory and visual processes. However, it is not clear which modality results in greater improvements in cognition, symptoms and quality of life. We aimed to investigate the impact of training auditory versus visual cognitive processes in global cognition in patients with schizophrenia.
METHODS


Seventy-nine schizophrenia participants were randomly assigned to either 40 h of auditory or visual computerized training. Auditory and visual exercises were chosen to be dynamically equivalent and difficulties increased progressively during the training. We evaluated cognition, symptoms and quality of life before, after 20 h, and after 40 h of training. ClinicalTrials.gov (1R03TW009002-01).
RESULTS


Participants who received the visual training showed significant improvements in global cognition compared to the auditory training group. The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only. Schizophrenia symptoms improved after training in both groups, whereas quality of life remained unchanged. Interestingly, there was a significant and positive correlation between improvements in attention and symptoms in the visual training group.
CONCLUSIONS


We conclude that the visual training and the auditory training are differentially efficient at remediating cognitive deficits and symptoms of clinically stable schizophrenia patients. Ongoing follow-up of participants will evaluate the durability of training effects on cognition and symptoms, as well as the potential impact on quality of life over time.",2020,"The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only.","['patients with schizophrenia', 'clinically stable schizophrenia patients', 'schizophrenia', 'Seventy-nine schizophrenia participants']","['visual training and the auditory training', 'Auditory and visual exercises', 'visual training', 'Auditory versus visual neuroscience-informed cognitive training', 'training auditory versus visual cognitive processes', '40\xa0h of auditory or visual computerized training']","['quality of life', 'global cognition', 'Schizophrenia symptoms', 'attention and symptoms', 'attention and reasoning and problem-solving', 'cognition, symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",79.0,0.0306674,"The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Scoriels', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Department of Psychiatry, University of Cambridge, United Kingdom.'}, {'ForeName': 'Larissa T', 'Initials': 'LT', 'LastName': 'Genaro', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Luana G C', 'Initials': 'LGC', 'LastName': 'Mororó', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Keffer', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Anna Luiza D V', 'Initials': 'ALDV', 'LastName': 'Guimarães', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Paulo V S', 'Initials': 'PVS', 'LastName': 'Ribeiro', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Filippe M', 'Initials': 'FM', 'LastName': 'Tannos', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Novaes', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Aniela I', 'Initials': 'AI', 'LastName': 'França', 'Affiliation': 'Faculdade de Letras, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Goldenstein', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': 'Department of Psychiatry, University of Cambridge, United Kingdom.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Panizzutti', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil. Electronic address: rogerio@icb.ufrj.br.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.017']
2090,32448693,Randomized trial of bupivacaine with epinephrine versus bupivacaine liposome suspension in patients undergoing minimally invasive lung resection.,"OBJECTIVES


Thoracic surgery can cause significant pain, and multiple strategies have been developed to control pain after surgery. We compared 2 bupivacaine formulations given intraoperatively: bupivacaine with epinephrine (1,200,000) or liposomal bupivacaine.
METHODS


This was a randomized, open-label study (NCT03560362). Eligible patients were adults scheduled for a minimally invasive lung procedure. Incision sites were injected with bupivacaine with epinephrine or liposomal bupivacaine before incision, and each intercostal space was injected with 1 mL of bupivacaine with epinephrine or liposomal bupivacaine entering the thoracic cavity. Patient-controlled analgesia was initiated in the recovery room. Pain was recorded using a visual analog scale. The primary outcome was the amount of narcotics taken during the postoperative hospital stay.
RESULTS


We recruited 50 patients; 25 received bupivacaine with epinephrine, and 25 received liposomal bupivacaine. The treatment groups were similar in age, histology, and procedure performed. There were no statistical differences between the treatment groups in the amount of narcotics required during the hospital stay (36.3 mg for bupivacaine and 38 mg for liposomal bupivacaine) or in pain assessed the day of surgery (5 and 5), the first day (3.5 and 2.3), second day (3 and 2.6), 2 weeks (0 and 1), or 3 months (0 and 0) postoperatively. Hospital length of stay and complications were also similar.
CONCLUSIONS


In a small, randomized study, we did not find significant differences between bupivacaine with epinephrine or liposomal bupivacaine in mitigating pain after minimally invasive lung resection. We currently favor using the less expensive nonliposomal bupivacaine preparations until additional data are available.",2020,"There were no statistical differences between the treatment groups in the amount of narcotics required during the hospital stay (36.3 mg for bupivacaine and 38 mg for liposomal bupivacaine) or in pain assessed the day of surgery (5 and 5), the first day (3.5 and 2.3), second day (3 and 2.6), 2 weeks (0 and 1), or 3 months (0 and 0) postoperatively.","['patients undergoing minimally invasive lung resection', 'Eligible patients were adults scheduled for a minimally invasive lung procedure', 'pain after minimally invasive lung resection']","['bupivacaine', 'bupivacaine with epinephrine, and 25 received liposomal bupivacaine', 'bupivacaine with epinephrine (1,200,000) or liposomal bupivacaine', 'bupivacaine with epinephrine or liposomal bupivacaine', 'epinephrine', 'bupivacaine liposome suspension', 'liposomal bupivacaine']","['amount of narcotics taken during the postoperative hospital stay', 'Pain', 'Hospital length of stay and complications', 'amount of narcotics required during the hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292960', 'cui_str': 'Procedure on lung'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C3247211', 'cui_str': 'Bupivacaine liposome'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0972242,"There were no statistical differences between the treatment groups in the amount of narcotics required during the hospital stay (36.3 mg for bupivacaine and 38 mg for liposomal bupivacaine) or in pain assessed the day of surgery (5 and 5), the first day (3.5 and 2.3), second day (3 and 2.6), 2 weeks (0 and 1), or 3 months (0 and 0) postoperatively.","[{'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Weksler', 'Affiliation': 'Division of Thoracic and Esophageal Surgery, Department of Thoracic and Cardiovascular Surgery, Allegheny General Hospital, Pittsburgh, Pa. Electronic address: benny.weksler@ahn.org.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Sullivan', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Sinai Hospital, Baltimore, Md.'}, {'ForeName': 'Lana Y', 'Initials': 'LY', 'LastName': 'Schumacher', 'Affiliation': 'Division of Thoracic and Esophageal Surgery, Department of Thoracic and Cardiovascular Surgery, Allegheny General Hospital, Pittsburgh, Pa.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.01.112']
2091,32448711,Video Education to Improve Preoperative Anxiety in the Bariatric Surgical Patient: A Quality Improvement Project.,"PURPOSE


Evidence supports that providing preoperative education using an audiovisual format is an effective method to reduce anxiety in the surgical patient. The purpose of this quality improvement project was to evaluate the effect of viewing a video tour of the perioperative division had on patient-perceived preoperative anxiety.
DESIGN


A quasi-experimental design using a pre-post survey method of two individual groups.
METHODS


Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment. Thirty patients in the comparison group received preoperative education with the current process of written and verbal instructions. Thirty patients in the intervention group received education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division. A paired sample t test was used to compare VAS-A results of the comparison and intervention groups.
FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.",2020,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","['Thirty patients in the intervention group received', 'patients having bariatric surgery', 'Bariatric Surgical Patient', 'Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment']","['Video Education', 'education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division', 'preoperative education with the current process of written and verbal instructions']","['anxiety levels', 'preoperative anxiety', 'self-perceived anxiety', 'Preoperative Anxiety']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0276817,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","[{'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Helms', 'Affiliation': 'Perioperative Services, Reading Hospital/Tower Health, West Reading, PA. Electronic address: lori.helms@towerhealth.org.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.012']
2092,32448712,Mindfulness meditation and exercise both improve sleep quality: Secondary analysis of a randomized controlled trial of community dwelling adults.,"OBJECTIVES


To assess the benefits of training in mindfulness-based stress reduction (MBSR) or moderate intensity exercise (EX) for improving sleep quality.
DESIGN


Randomized controlled trial.
SETTING


Outpatient, community-based.
PARTICIPANTS


Healthy adults (n = 413) aged 30-69 who did not regularly exercise or practice meditation, and who had no known prior sleep problems.
INTERVENTIONS


1) 8-weeks of MBSR training; 2) matched EX training; or 3) wait-list control.
MEASUREMENTS


The Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at 1, 3, 5, and 7-month follow-up visits.
ANALYSIS


Total PSQI scores and three PSQI factors (perceived sleep quality; daily disturbances, sleep efficiency) were assessed using linear mixed effects regression models for longitudinal data.
RESULTS


Compared to controls, PSQI global scores improved significantly for EX (mean change -0.98 points [95% CI -1.56, -0.41] p = 0.001) and marginally for MBSR (-0.53 [-1.10, 0.04] p = 0.07). The perceived sleep quality factor improved for both EX (-0.18 [-0.30, -0.07] p = 0.002) and MBSR (-0.12 [-0.24, -0.01] p = 0.035). The daily disturbances factor improved slightly more for MBSR (-0.13 [-0.22, -0.033] p = 0.008) than EX (-0.09 [-0.19, 0.004] p = 0.06). The sleep efficiency factor did not improve after MBSR (0.08 [-0.045, 0.21] p = 0.2) or EX (-0.07 [-0.20, 0.06] p = 0.3). Improvements in the sleep quality were sustained over 7 months for both groups.
CONCLUSIONS


Training in MBSR and EX produced small but statistically significant and sustained improvements in sleep quality. For EX participants, this improvement was due primarily to improvements in perceived sleep quality. For MBSR, the decrease in daytime disturbance was more important.",2020,The sleep efficiency factor did not improve after MBSR (0.08,"['Healthy adults (n\xa0=\xa0413) aged 30-69 who did not regularly exercise or practice meditation, and who had no known prior sleep problems', 'community dwelling adults', 'Outpatient, community-based']","['Mindfulness meditation and exercise', 'MBSR training; 2) matched EX training; or 3) wait-list control', 'training in mindfulness-based stress reduction (MBSR) or moderate intensity exercise (EX']","['daily disturbances factor', 'sleep efficiency factor', 'daytime disturbance', 'Pittsburgh Sleep Quality Index (PSQI', 'Total PSQI scores and three PSQI factors (perceived sleep quality; daily disturbances, sleep efficiency', 'perceived sleep quality', 'MBSR', 'MBSR ', 'sleep quality factor', 'sleep quality', 'PSQI global scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",413.0,0.0358618,The sleep efficiency factor did not improve after MBSR (0.08,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin, School of Medicine and Public Health, 1100 Delaplaine Court, Madison United States. Electronic address: bruce.barrett@fammed.wisc.eu.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Harden', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin, School of Medicine and Public Health, 1100 Delaplaine Court, Madison United States.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Brown', 'Affiliation': 'University of Wisconsin-Madison, School of Nursing, United States.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Coe', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'David Geffen School of Medicine, Psychiatry, University of California - Los Angeles, United States.'}]",Sleep health,['10.1016/j.sleh.2020.04.003']
2093,32448722,Discrete Fiber Structures Dictate Human Gut Bacteria Outcomes.,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes. A recent randomized controlled trial (RCT) reported by Deehan et al. showed similar responses within treatment groups and dose-response plateauing at 35 g/d. These results support a proposed alignment of discrete dietary fiber (DF) structures with gut bacteria.,2020,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes.,[],[],[],[],[],[],,0.0492586,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes.,"[{'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Hamaker', 'Affiliation': 'Whistler Center for Carbohydrate Research, Department of Food Science, Purdue University, West Lafayette, IN 47906, USA. Electronic address: hamakerb@purdue.edu.'}, {'ForeName': 'Thaisa Moro', 'Initials': 'TM', 'LastName': 'Cantu-Jungles', 'Affiliation': 'Whistler Center for Carbohydrate Research, Department of Food Science, Purdue University, West Lafayette, IN 47906, USA.'}]",Trends in endocrinology and metabolism: TEM,['10.1016/j.tem.2020.05.002']
2094,32448781,What is the feasibility and observed effect of two implementation packages for stroke rehabilitation therapists implementing upper limb guidelines? A cluster controlled feasibility study.,"BACKGROUND


Hand and arm activity after stroke improves with evidence-based rehabilitation. Therapists face known barriers when providing evidence-based rehabilitation and require support to implement guidelines. The aim of this study was to investigate the feasibility of two implementation packages on guideline adherence by occupational therapists and physiotherapists, and explore effect on patient upper limb outcomes.
METHOD


This was a non-randomised clustered feasibility study of occupational and physiotherapy rehabilitation services (n=3 inpatient and n=3 outpatient services). Services were allocated to one of three groups: (group A) facilitator-mediated implementation package, (group B) self-directed implementation package or (group C) usual care (control); we recruited n=1 inpatient and n=1 outpatient service per group. Outcomes of feasibility, adherence to guidelines (medical file audits) and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test) and practice (minutes/week) were collected at baseline and after 3 months of intervention.
RESULTS


29 therapists (8 in group A, 13 in groups B and 8 in group C) and 55 patients participated. Both the facilitator-mediated and the self-directed implementation packages were feasible to deliver in the rehabilitation setting. Therapists in group A improved with respect to guideline adherence (medical file audits; median within-group proportion difference of 0.29 (95% CI 0.22 to 0.36, p<0.0001) preintervention to postintervention). No significant within-group differences from baseline to postintervention were found in group B or group C, and no between-group differences were found for upper limb outcomes.
CONCLUSION


A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation. An adequately powered study is planned to understand how to support therapists to provide evidence-based upper limb rehabilitation after stroke.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12619000596101).",2020,"A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation.",['n=3 inpatient and n=3 outpatient services'],"['occupational and physiotherapy rehabilitation services', 'facilitator-mediated implementation package, (group B) self-directed implementation package or (group C) usual care (control']","['feasibility, adherence to guidelines (medical file audits) and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test) and practice (minutes/week', 'guideline adherence', 'upper limb outcomes']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0574997,"A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jolliffe', 'Affiliation': 'Occupational Therapy, Alfred Health, Melbourne, Victoria, Australia l.jolliffe@alfred.org.au.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Occupational Therapy, Alfred Health, Melbourne, Victoria, Australia.'}]",BMJ open quality,['10.1136/bmjoq-2020-000954']
2095,32448782,Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis.,"OBJECTIVES


To report the 10-year outcome of lupus nephritis (LN) treated with mycophenolate mofetil (MMF) or tacrolimus (TAC) induction in a randomised controlled trial.
METHODS


Patients with active LN were treated with MMF or TAC combined with high-dose prednisolone. Responders were switched to azathioprine (AZA) at month 6. Clinical outcomes at 10 years (renal flares, renal function decline and mortality) were assessed. Factors affecting prognosis were studied by Cox regression. Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR) at different time points were evaluated for their prediction of a poor prognosis by receiver operating characteristic (ROC) analysis.
RESULTS


150 patients were studied (age 35.5±12.8 years). Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71). AZA maintenance was given to 79% patients. After 118.2±42 months, proteinuric and nephritic renal flares occurred in 34% and 37% of the MMF, and 53% and 30% of the TAC groups of patients, respectively (p=0.49). The cumulative incidence of a composite outcome of ↓eGFR ≥30%, chronic kidney disease stage 4/5 or death at 10 years was 33% in both groups (p=0.90). Factors independently associated with a poor renal prognosis were first-time LN (HR 0.12 (0.031 to 0.39); p=0.01), eGFR (HR 0.98 (0.96 to 0.99); p=0.008) and no response at month 6 (HR 5.18 (1.40 to 19.1); p=0.01). ROC analysis revealed an uPCr >0.75 and eGFR of <80 mL/min at month 18 best predicted a poor renal prognosis.
CONCLUSIONS


Long-term data confirmed non-inferiority of TAC to MMF as induction therapy of LN. An uPCr≤0.75 and eGFR of ≥80 mL/min at month 18 best predicted a favourable 10-year outcome and may be suitable targets for induction/consolidation therapy.
TRIAL REGISTRATION NUMBER


NCT00371319.",2020,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"['150 patients were studied (age 35.5±12.8\u2009years', 'Patients with active LN', 'active lupus nephritis']","['azathioprine (AZA', 'AZA maintenance', 'MMF or TAC combined with high-dose prednisolone', 'tacrolimus with mycophenolate mofetil', 'mycophenolate mofetil (MMF) or tacrolimus (TAC']","['chronic kidney disease stage 4/5 or death', 'Clinical outcomes at 10 years (renal flares, renal function decline and mortality', 'Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR', 'eGFR', 'Complete renal response rate', 'proteinuric and nephritic renal flares', 'poor renal prognosis']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",150.0,0.119119,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong ccmok2005@yahoo.com.'}, {'ForeName': 'Ling Yin', 'Initials': 'LY', 'LastName': 'Ho', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Shirley King Yee', 'Initials': 'SKY', 'LastName': 'Ying', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Man Chi', 'Initials': 'MC', 'LastName': 'Leung', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Hung', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Woon Leung', 'Initials': 'WL', 'LastName': 'Ng', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217178']
2096,32448788,Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial.,"INTRODUCTION


Treatment options for non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes (T2D) are still a matter of debate. We compared the effects of a diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs) on liver fat in T2D.
RESEARCH DESIGN AND METHODS


According to a parallel design, 49 individuals with T2D, overweight/obese, with high waist circumference, 35-75 years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content, were randomly assigned to an 8-week isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C (n=23). Before and after the intervention, liver fat content was evaluated by proton magnetic resonance spectroscopy ( 1 H-MRS).  1 H-MRS complete data were available for n=21 (MUFA diet) and n=18 (multifactorial diet) participants.
RESULTS


Adherence to dietary interventions was optimal. No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed. Liver fat significantly decreased after both the multifactorial diet (9.18%±7.78% vs 5.22%±4.80%, p = 0.003) and the MUFA diet (9.47%±8.89% vs 8.07%±8.52%, p = 0.027) with a statistically significant difference between changes either in absolute terms (-4.0%±4.5% vs -1.4%±2.7%, p=0.035) or percent (-40%±33% vs -19%±25%, p=0.030).
CONCLUSIONS


An isocaloric multifactorial diet including several beneficial dietary components induced a clinically relevant reduction of liver fat in patients with T2D, more pronounced than that induced by simply replacing saturated fat with MUFA. This suggests that the 'optimal diet' for NAFLD treatment in T2D should be based on synergic actions of different dietary components on multiple pathophysiological pathways.
TRIAL REGISTRATION NUMBER


NCT03380416.",2020,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","['49 individuals with T2D, overweight/obese, with high waist circumference, 35-75\u2009years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content', 'patients with T2D', 'patients with type 2 diabetes', 'patients with type 2 diabetes (T2D']","['isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C', 'multifactorial ecosustainable isocaloric diet', 'diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs']","['liver fat', 'MUFA diet', 'Liver fat', 'body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes', 'liver fat content']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",49.0,0.0243611,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Brancato', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Monti', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Tommasone', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cipriano', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Clemente', 'Affiliation': 'Institute for Research on Population and Social Policies, National Research Council, Fisciano, Italy.'}, {'ForeName': 'Peppino', 'Initials': 'P', 'LastName': 'Mirabelli', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Salvatore', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy rivelles@unina.it.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001342']
2097,32448790,10-Valent pneumococcal non-typeable  H. influenzae  protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13) as a booster dose to broaden and strengthen protection from otitis media (PREVIX_BOOST) in Australian Aboriginal children: study protocol for a randomised controlled trial.,"INTRODUCTION


Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi) are major otitis media pathogens that densely co-colonise the nasopharynx and infect the middle ear of Australian Aboriginal infants from very early in life. Our co-primary hypotheses are that at 18 months of age infants receiving 10-valent pneumococcal  Haemophilus influenzae  protein D conjugate vaccine (PHiD-CV10) compared with those receiving 13-valent pneumococcal conjugate vaccine (PCV13) as a booster at 12 months of age will have higher antibody levels to  Haemophilus influenzae  protein D and that infants receiving PCV13 will have higher antibody levels to PCV13-only serotypes 3, 6A and 19A.
METHODS AND ANALYSES


Our randomised controlled trial will enrol 270 Aboriginal children at 12 months of age to a booster dose of either PHiD-CV10 or PCV13. Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible. The co-primary assessor-blinded outcomes when the infants are 18 months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35 µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported.
ETHICS AND DISSEMINATION


Ethics committees of NT Department of Health, Menzies, WA Department of Health and WA Aboriginal Health approved the study. Results will be presented to communities, at conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT01735084.",2020,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","['Australian Aboriginal children', '270 Aboriginal children at 12 months of age to a booster dose of either', 'infants are 18\u2009months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35\u2009µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported']","['13-valent pneumococcal conjugate vaccine (PCV13', 'Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi', 'PHiD-CV10 or PCV13', '10-Valent pneumococcal non-typeable  H. influenzae  protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532292', 'cui_str': 'Ehrlich units/milliliter'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]",[],270.0,0.230418,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","[{'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mulholland', 'Affiliation': 'Infection and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Center American Indian Health, John Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Torzillo', 'Affiliation': 'Respiratory Medicine, Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'Director, National Centre for Immunisation Research and Surveillance, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Balloch', 'Affiliation': 'Pneumococcal Immunology, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Cerebral Palsy and Rehabilitation Research Centre, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lehmann', 'Affiliation': 'Division of Population Sciences, Telethon Institute for Child Health Research, West Perth, Western Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Director, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Krause', 'Affiliation': 'Centre for Disease Control, Department of Health, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Infectious Disease Implementation Research Team, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Licciardi', 'Affiliation': 'Infections and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia amanda.leach@menzies.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-033511']
2098,32448796,Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study.,"INTRODUCTION


The Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
METHODS AND ANALYSIS


The study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial.
ETHICS AND DISSEMINATION


The study has received National Health Service ethical approval from the London-Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment.
TRIAL REGISTRATION NUMBER


NCT03628027.",2020,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","['depression in UK primary care', 'general practitioners (GPs) in the UK primary care service']","['treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices', 'antidepressant advisor (ADeSS']",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",[],,0.105514,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","[{'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Carr', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Diede', 'Initials': 'D', 'LastName': 'Fennema', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""Department of Health Services & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK Roland.zahn@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2019-035905']
2099,32448894,Withholding primary PcP prophylaxis in virologically suppressed HIV patients: An emulation of a pragmatic trial in COHERE.,"BACKGROUND


Using data from the COHERE collaboration, we investigated whether primary prophylaxis for Pneumocystis Pneumonia (PcP) might be withheld in all patients on antiretroviral therapy with suppressed plasma HIV RNA (≤ 400c/mL) irrespective of CD4 count.
METHODS


We implemented an established causal inference approach whereby observational data is used to emulate a randomised trial. Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤ 200 cells/µL in line with existing recommendations. We compared the following two strategies for stopping prophylaxis: i.) when CD4 count was above 200 cells/µL for more than 3 months, or ii.) when the patient was virologically suppressed (two consecutive HIV RNA ≤ 400c/mL). Patients were artificially censored if they did not comply with these stopping rules. We estimated the risk of primary PcP in patients on ART, using the hazard ratio to compare the stopping strategies by fitting a pooled logistic model, including inverse probability weights to adjust for the selection bias introduced by the artificial censoring.
RESULTS


4'813 patients (10'324 person years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as endpoint, the adjusted hazard ratio (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared to the existing guidelines (aHR 0.8 with 95% CI [0.6, 1.1], p = 0.2).
CONCLUSIONS


The study suggests that primary PcP prophylaxis might be safely withheld in confirmed ART-virologically suppressed patients, regardless of their CD4 count.",2020,"With primary PcP diagnosis as endpoint, the adjusted hazard ratio (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared to the existing guidelines (aHR 0.8 with 95% CI [0.6, 1.1], p = 0.2).
","[""4'813 patients (10'324 person years) complied with eligibility conditions for the emulated trial"", 'virologically suppressed HIV patients', 'Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤ 200 cells/µL in line with existing recommendations']",[],['adjusted hazard ratio (aHR'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1535939', 'cui_str': 'Pneumocystosis'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.158964,"With primary PcP diagnosis as endpoint, the adjusted hazard ratio (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared to the existing guidelines (aHR 0.8 with 95% CI [0.6, 1.1], p = 0.2).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Atkinson', 'Affiliation': 'Dept. of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zwahlen', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Barger', 'Affiliation': 'Univ. Bordeaux, ISPED, Inserm Bordeaux Population Health, team MORPH3EUS, UMR 1219, Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""d'Arminio Monforte"", 'Affiliation': 'Institute of Infectious Diseases, Department of Health Sciences, University of Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'De Wit', 'Affiliation': 'Dept. of Infectious Diseases, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghosn', 'Affiliation': 'APHP.Nord-Université de Paris, Service des Maladies Infectieuses et Tropicales, Hôpital Bichat, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Girardi', 'Affiliation': 'Clinical Epidemiology Unit, National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Svedhem-Johansson', 'Affiliation': 'Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Morlat', 'Affiliation': 'Univ Bordeaux, ISPED, Inserm Bordeaux Population Health, team MORPH3EUS, UMR 1219, Bordeaux, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mussini', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Noguera-Julian', 'Affiliation': 'Malalties Infeccioses i Resposta Inflamatòria Sistèmica en Pediatria, Unitat d´Infeccions, Servei de Pediatria, Institut de Recerca Pediàtrica Hospital Sant Joan de Déu, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stephan', 'Affiliation': 'Infectious Diseases Unit at Medical Center no., Frankfurt University Hospital, Goethe University, Frankfurt, Germany, for Frankfurt HIV Cohort Study.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Kirk', 'Affiliation': 'CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mocroft', 'Affiliation': 'Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, UCL, Rowland Hill St, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Reiss', 'Affiliation': 'HIV Monitoring Foundation, Meibergdreef, AZ Amsterdam, Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Miro', 'Affiliation': 'Infectious Diseases Service, Hospital Clinic - IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'Dept. of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Furrer', 'Affiliation': 'Dept. of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa615']
2100,32448931,The disaster worker resiliency training program: a randomized clinical trial.,"OBJECTIVES


Disaster workers are at elevated risk for mental health problems as a result of trauma exposures during response efforts. One possible way to prevent mental health problems is to build-up coping resources that promote resilience to the effects of disaster work. The primary aim of this study was to evaluate the efficacy of a resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT), in disaster workers previously exposed to Hurricane Sandy.
METHODS


Disaster workers (N = 167) were randomly assigned to the DWRT workshop (n = 78) or a waitlist (n = 89). Workers completed self-report measures on healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms at baseline and 3-month follow-up. They also completed a measure assessing subsequent trauma-exposure between the baseline and 3-month post-intervention.
RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02). Among participants reporting subsequent trauma exposures between T1 and T2  (n = 101), participants in the waitlist condition, were more likely to report significant increases in perceived stress (η 2  = .07, p < .01), PTSD (η 2  = .05, p = .03), and depression (η 2  = .07, p < .01) symptoms.
CONCLUSIONS


Participation in the resilience workshop promoted engagement in positive health behaviors and reduced the incidence of mental health symptoms, especially when administered prior to a repeat trauma exposure. Further research is needed to evaluate the long-term health effects of participation in the program.",2020,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","['Disaster workers (N\u2009=\u2009167', 'disaster workers previously exposed to Hurricane Sandy']","['DWRT workshop', 'resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT']","['incidence of mental health symptoms', 'healthy lifestyle behaviors', 'stress management', 'positive health behaviors', 'spiritual growth', 'PTSD', 'healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms', 'depression', 'perceived stress']","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020183', 'cui_str': 'Hurricane'}]","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687002', 'cui_str': 'Spiritual growth'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",167.0,0.0234846,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","[{'ForeName': 'Brittain L', 'Initials': 'BL', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA. Brittain.Mahaffey@stonybrookmedicine.edu.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Mackin', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosen', 'Affiliation': 'National Clearinghouse for Worker Safety & Health Training, Washington, DC, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Taioli', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA.'}]",International archives of occupational and environmental health,['10.1007/s00420-020-01552-3']
2101,32448935,Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL).,"INTRODUCTION AND HYPOTHESIS


The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears.
METHODS


In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into ""avoidance of episiotomy"" (the study group in which episiotomy was allowed only in cases of fetal distress) or ""standard care."" The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears.
RESULTS


The participants were randomized into ""standard care"" (n = 337) vs. ""no episiotomy"" (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17-1.50) in favor of the ""no episiotomy"" group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126).
CONCLUSIONS


Since decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237.",2020,"Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004).",['primiparous women underwent'],"['standard care"" (n\u2009=\u2009337) vs. ""no episiotomy', 'randomization into ""avoidance of episiotomy']","['Episiotomy rates', 'severe tears', 'incidence of advanced (3rd- and 4th-degree) perineal tears', 'risk of advanced tears']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.150924,"Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004).","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sagi-Dain', 'Affiliation': 'Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel. lena2303@gmail.com.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Kreinin-Bleicher', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Bahous', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Noga', 'Initials': 'N', 'LastName': 'Gur Arye', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Shema', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Eshel', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Caspin', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Gonen', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}]",International urogynecology journal,['10.1007/s00192-020-04332-2']
2102,32448972,Comparison between shockpulse and pneumatic lithotripsy in percutaneous nephrolithotomy.,"PURPOSE


To compare the effectiveness and safety of shockpulse with pneumatic lithotripsy in percutaneous nephrolithotomy.
METHODS


A prospective randomized comparative study was performed in Department of Urology, Bir Hospital for 1-year duration with 61 patients in shockpulse (Group 1) and 58 patients in pneumatic lithoclast (Group 2) groups, respectively. Patient's demographics, stone characteristics, hemoglobin drop, hospital stay, operative duration, stone fragmentation time and postoperative complications were compared.
RESULTS


The two groups did not differ significantly in terms of patient's demographic and stone characteristics. The mean hemoglobin drop was 1.96 ± 1.48 g/dl in Group 1 and 2.32 ± 1.38 g/dl in Group 2 (p = 0.16) and hospital stay was 3.14 ± 1.42 days in Group 1 and 3.29 ± 1.82 days in Group 2 (p = 0.62). The number of cases that required multiple tracts were six (9.8%) in Group 1 and 12 (20.68%) in Group 2 (p = 0.12). The stone-free rates were 78.69% in Group 1 and 74.13% in Group 2 (p = 0.66). Mean total operation time was 43.23 ± 18.49 min in Group 1 as compared to 51.53 ± 19.48 min in Group 2 (p = 0.0188). Mean stone fragmentation time was 17.95 ± 15.25 min in Group 1 and 24.37 ± 11.12 min in Group 2 (p = 0.0096). Overall complications were not significant between the two Groups (p = 0.58). On sub-analysis of the patients with single tracts in both groups the results were comparable to patients with single and multiple tracts combined.
CONCLUSIONS


Despite similar stone-free rates and complications between the two Groups, shockpulse has significantly lower stone fragmentation time and total operation time as compared to pneumatic lithotripsy.",2020,"Despite similar stone-free rates and complications between the two Groups, shockpulse has significantly lower stone fragmentation time and total operation time as compared to pneumatic lithotripsy.","['Department of Urology, Bir Hospital for 1-year duration with 61 patients in shockpulse (Group 1) and 58 patients in pneumatic lithoclast (Group 2) groups, respectively', 'percutaneous nephrolithotomy']","['shockpulse and pneumatic lithotripsy', 'pneumatic lithotripsy']","['Mean stone fragmentation time', 'stone-free rates', 'Mean total operation time', ""Patient's demographics, stone characteristics, hemoglobin drop, hospital stay, operative duration, stone fragmentation time and postoperative complications"", 'stone fragmentation time and total operation time', 'mean hemoglobin drop', 'Overall complications', ""patient's demographic and stone characteristics"", 'hospital stay']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441577', 'cui_str': 'Ballistic fragmentation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0275498,"Despite similar stone-free rates and complications between the two Groups, shockpulse has significantly lower stone fragmentation time and total operation time as compared to pneumatic lithotripsy.","[{'ForeName': 'Birendra Kumar', 'Initials': 'BK', 'LastName': 'Yadav', 'Affiliation': 'Deparment of Urology, National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal. ucmsbirendra@gmail.com.'}, {'ForeName': 'Robin Bahadur', 'Initials': 'RB', 'LastName': 'Basnet', 'Affiliation': 'Deparment of Urology, National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Deparment of Urology, National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Shrestha', 'Affiliation': 'Deparment of Urology, National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}]",World journal of urology,['10.1007/s00345-020-03239-3']
2103,32448992,"Effectiveness of wheat soya blend supplementation during pregnancy and lactation on pregnancy outcomes and nutritional status of their infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan: a cluster randomized-controlled trial.","PURPOSE


We aimed to assess the effectiveness of wheat soya blend plus (WSBP) provided during pregnancy and lactation on weight gain during pregnancy, reduction of low birthweight (LBW), and improvement in nutritional status in infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan.
METHODS


A cluster randomized-controlled trial was conducted in Thatta and Sujawal districts in Pakistan from August 2014 to December 2016. A total of 2030 pregnant women were enrolled in the study. These women and their infants were followed during pregnancy and first 6 months of life. Pregnant women received a monthly ration of 5 kg (i.e., 165 g/day) of WSB + during pregnancy and the first 6 months of their lactation period.
RESULTS


There was no difference in weight gain during pregnancy between the intervention and control groups (n = 496, 326.7 g/week 95% CI 315.2-338.1 vs. (n = 507, 306.9 g/week, 95% CI 279.9-333.9 P = 0.192), after adjustment with different factors. The reduction in the prevalence of LBW was not different between intervention and control groups (n = 325, 34.0%, 95% CI 31.7-36.4, vs. (n = 127, 34.3%, 95% CI 27.2-41.5, P = 0.932). Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group. However, no difference was noted on reduction in the risk of stunting among infants at 6 months of age in the intervention and control group (n = 1318 RR 0.91, 95% CI 0.78-1.07, P = 0.253) after adjustment. A significant reduction in anemia was noted (n = 1328 RR 0.94, 95% CI 0.91-0.98, P = 0.002) in infants at 6 months of age in the intervention as compared to the control group in adjusted analysis.
CONCLUSIONS


Provision of WSB + during pregnancy and the first 6 months of lactation is effective in reducing the risk of under nutrition and anemia in infants at 6 months of age. This study can potentially guide the government and donor agencies in investing in nutritional programmes, especially for pregnant and lactating women living in vulnerable settings.",2020,"Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group.","['infants at 6\xa0months of age in Thatta and Sujawal districts of Sindh, Pakistan', 'pregnant and lactating women living in vulnerable settings', '2030 pregnant women were enrolled in the study', 'Thatta and Sujawal districts in Pakistan from August 2014 to December 2016', 'their infants at 6\xa0months\xa0of age in Thatta and Sujawal districts of Sindh, Pakistan', 'Pregnant women']","['wheat soya blend supplementation', 'wheat soya blend plus (WSBP']","['weight gain during pregnancy, reduction of low birthweight (LBW), and improvement in nutritional status', 'risk of under nutrition and anemia', 'weight gain during pregnancy', 'pregnancy outcomes and nutritional status of', 'risk of stunting', 'anemia', 'prevalence of LBW']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",2030.0,0.123888,"Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group.","[{'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan. sajid.soofi@aku.edu.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Institute for Global Health and Development, A, Aga Khan University, Karachi, Pakistan.'}]",European journal of nutrition,['10.1007/s00394-020-02276-3']
2104,32449010,A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression.,"Accelerated repetitive transcranial magnetic stimulation (rTMS) protocols are being increasingly studied because of their potential to provide quicker and enhanced treatment efficacy. However, there is a lack of accelerated deep TMS with H1-coil (adTMS) treatment research. This randomized pilot study investigated the efficacy and safety of adTMS protocols. Twenty-eight TRD patients received 20-min sessions twice daily for 10 or 15 days. Primary outcomes were changes in Hamilton Depression Rating Scale (HDRS) scores and discontinuation because of adverse events (AE). Secondary outcomes were response, remission, daily changes in Beck Depression Inventory-II (BDI-II) scores, and AE incidence. HDRS scores decreased by 13 (95% CI 11-17; 59%, 95% CI 45-73%) and 13 (95% CI 11-14; 62%, 95% CI 54-69%) points in the 10- and 15-day protocols, respectively. The adjusted difference between the two protocols was not significant or clinically relevant. Remission was achieved by 38% and 42% after 10-day and 15-day protocols, respectively. The intervention was discontinued because of AEs in 3/33 (9%) patients. The BDI-II decreases were significant and clinically relevant during the first 8 days. Twice-daily adTMS for 10 days seems to be safe and effective, with rapid clinical benefits during the first week of treatment. These promising results warrant further investigation in larger randomized clinical trials comparing adTMS with the standard dTMS protocol.",2020,"HDRS scores decreased by 13 (95% CI 11-17; 59%, 95% CI 45-73%) and 13 (95% CI 11-14; 62%, 95% CI 54-69%) points in the 10- and 15-day protocols, respectively.",[],"['Accelerated repetitive transcranial magnetic stimulation (rTMS', 'accelerated deep transcranial magnetic stimulation protocols']","['HDRS scores', 'changes in Hamilton Depression Rating Scale (HDRS) scores and discontinuation because of adverse events (AE', 'Remission', 'BDI-II decreases', 'efficacy and safety', 'response, remission, daily changes in Beck Depression Inventory-II (BDI-II) scores, and AE incidence']",[],"[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0599221,"HDRS scores decreased by 13 (95% CI 11-17; 59%, 95% CI 45-73%) and 13 (95% CI 11-14; 62%, 95% CI 54-69%) points in the 10- and 15-day protocols, respectively.","[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Filipčić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia. igor.filipcic@pbsvi.hr.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Šimunović Filipčić', 'Affiliation': 'Department of Psychiatry and Psychological Medicine, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Strahimir', 'Initials': 'S', 'LastName': 'Sučić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Milovac', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Natko', 'Initials': 'N', 'LastName': 'Gereš', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Matić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Čelić-Ružić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Zečević Penić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Orgulan', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Požgaj', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}, {'ForeName': 'Žarko', 'Initials': 'Ž', 'LastName': 'Bajić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Jankomir 11, pp 68, 10 090, Zagreb, Croatia.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01141-y']
2105,32449022,Acetic acid disinfection as a potential adjunctive therapy for non-severe COVID-19.,"PURPOSE


SARS-CoV-2 is a new pandemic influenza caused by a coronavirus which main route of transmission is through exhaled droplets that primarily infect the nose and the nasopharynx. The aim of this paper is to evaluate the effect of acetic acid, the active component of vinegar, as a potential disinfectant agent for upper airways.
METHODS


Twenty-nine patients were enrolled and divided into two groups: group 1 (14 patients) was composed of patients treated with off-label hydroxychloroquine and lopinavir/ritonavir, whereas group 2 (15 patients) was composed of patients treated with hydroxychloroquine only, combined with the inhalation of acetic acid disinfectant at a 0.34% concentration. A questionnaire-based evaluation of symptoms was performed after 15 days in both groups.
RESULTS


It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
CONCLUSIONS


Considering its potential benefits and high availability, acetic acid disinfection appears to be a promising adjunctive therapy in cases of non-severe COVID-19 and deserves further investigation.",2020,"It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
",['Twenty-nine patients'],"['hydroxychloroquine only, combined with the inhalation of acetic acid disinfectant', 'acetic acid', 'Acetic acid disinfection', 'label hydroxychloroquine and lopinavir/ritonavir']",['individual symptoms'],"[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",29.0,0.0329194,"It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pianta', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vinciguerra', 'Affiliation': 'Division of Head and Neck Department, Otorhinolaryngology Unit, San Raffaele Hospital, IRCCS San Raffaele Scientific Institute, Via Olgettina, 68, 20100, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bertazzoni', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mangiatordi', 'Affiliation': 'Department of Emergency, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Lund', 'Affiliation': 'Royal National Throat, Nose and Ear Hospital, UCLH, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trimarchi', 'Affiliation': 'Division of Head and Neck Department, Otorhinolaryngology Unit, San Raffaele Hospital, IRCCS San Raffaele Scientific Institute, Via Olgettina, 68, 20100, Milan, Italy. trimarchi.matteo@hsr.it.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06067-8']
2106,32449083,Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis.,"BACKGROUND AND OBJECTIVE


Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have significant efficacy in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) mortality in patients with type 2 diabetes mellitus (T2DM). However, there are differences in HF outcomes between the SGLT2i. Therefore, we compared the cost needed to achieve these outcomes between empagliflozin, canagliflozin, and dapagliflozin.
METHODS


We calculated the cost needed to treat (CNT) in order to prevent one event of hHF or CV mortality, by multiplying the annualized number needed to treat (NNT) to prevent one event, by the annual cost of each therapy. Efficacy estimates were extracted from published randomized controlled trial (RCT) data. A sensitivity analysis was performed to mitigate differences between the RCT populations. Drug costs were extracted from the 2020 US National Average Drug Acquisition Cost listing.
RESULTS


We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin. The sensitivity analysis confirmed the cost advantage of empagliflozin.
CONCLUSIONS


Our findings suggest that empagliflozin prescribed for preventing CV death or hHF in T2DM patients seems to be cost saving compared to treatment with canagliflozin, and dapagliflozin.",2020,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'empagliflozin', 'empagliflozin, canagliflozin, and dapagliflozin', 'Sodium-Glucose Cotransporter 2 Inhibitors']","['HF outcomes', 'cardiovascular (CV) mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.173062,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","[{'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Arbel', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel. ronen.arbel@gmail.com.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Aboalhasan', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hammerman', 'Affiliation': 'Department of Pharmaceutical Technology Assessment, Clalit Health Services Headquarters, Tel-Aviv, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Azuri', 'Affiliation': 'Diabetes Clinic, Central District, Maccabi Healthcare Services, Tel Aviv, Israel.'}]",Clinical drug investigation,['10.1007/s40261-020-00929-z']
2107,32449130,"Resveratrol adjunct to methylphenidate improves symptoms of attention-deficit/hyperactivity disorder: a randomized, double-blinded, placebo-controlled clinical trial.","Current pharmacological approaches have failed to provide complete remission for patients with Attention-Deficit/Hyperactivity Disorder (ADHD). This study aimed to evaluate the efficacy and tolerability of resveratrol (that have been shown to have antioxidative, anti-inflammatory, and anti-apoptotic effects) as an adjunct to methylphenidate in pharmacologic treatment of ADHD. This 8-week, double-blinded, placebo-controlled trial randomized 66 participants to receive either 500 mg/day resveratrol or matched placebo in addition to methylphenidate. ADHD symptoms were evaluated in the patients using the Parent and Teacher versions of ADHD-Rating Scale (ADHD-RS) at three measurement points with time intervals of 4 weeks. Furthermore, the tolerability of the treatment strategies was systematically compared. Repeated measures analysis demonstrated a significant effect for time-treatment interaction on all three subscales of the Parent ADHD-RS during the trial period (total: p = 0.015; inattention: p = 0.032; hyperactivity/impulsivity: p = 0.036). Nevertheless, the effect for time-treatment interaction was not significant for the Teacher version of ADHD-RS (total: F = 0.81, df = 1.33, p = 0.401; inattention: F = 0.57, df = 1.37, p = 0.507; hyperactivity/impulsivity: F = 0.65, df = 1.34, p = 0.466). The frequencies of complications in the treatment groups were similar. Resveratrol administration for a duration of 8 weeks improved characteristic symptoms in patients with ADHD according to their parents. Further investigations containing larger sample sizes, longer supplementation periods, and dose-response evaluations are required to replicate these findings in ADHD children more confidently.",2020,Repeated measures analysis demonstrated a significant effect for time-treatment interaction on all three subscales of the Parent ADHD-RS during the trial period (total:,"['patients with ADHD according to their parents', 'patients with Attention-Deficit/Hyperactivity Disorder (ADHD']","['placebo', 'methylphenidate', '500\xa0mg/day resveratrol or matched placebo', 'Resveratrol adjunct to methylphenidate']","['characteristic symptoms', 'efficacy and tolerability', 'ADHD symptoms', 'frequencies of complications', 'symptoms of attention-deficit/hyperactivity disorder', 'Teacher versions of ADHD-Rating Scale (ADHD-RS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.376458,Repeated measures analysis demonstrated a significant effect for time-treatment interaction on all three subscales of the Parent ADHD-RS during the trial period (total:,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rafeiy-Torghabeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ashraf-Ganjouei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran.'}, {'ForeName': 'Sayna', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337, Tehran, Iran. s.akhond@neda.net.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01562-z']
2108,32247794,Subperiosteal versus Subdural Drain After Burr-hole Drainage Under Blood Thinners: A Subanalysis of the cSDH-Drain RCT.,"OBJECTIVE


The chronic subdural hematoma (cSDH)-Drain trial compared recurrence rates and clinical outcome associated with the use of subperiosteal drain (SPD) and subdural drain (SDD) after burr-hole drainage for cSDH. This subgroup analysis aimed to determine whether one drain type is preferable for patients treated with platelet inhibitors (PI) or anticoagulants (AC).
METHODS


This subanalysis included 133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial. For these patients the association between the drain type used and recurrence rates, mortality, as well as clinical outcome at 6 weeks and 12 months follow-up were analyzed using a logistic regression analysis model. Additionally, recurrence rates, clinical outcome, and mortality were assessed for each PI or AC type separately.
RESULTS


The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36). Outcome measurements and mortality did not differ significantly between both groups at 6-week and 12-month follow-up. In addition, there was no statistically significant association between drain type and recurrence rate or mortality when comparing data for each PI or AC type. At 24 hours postoperatively, significantly more patients under phenprocoumon and natrium-dalteparin had a Glasgow Coma Scale score between 13 and 15 in the SDD group compared with the SPD group (P = 0.006), whereaas at 6-week follow-up significantly more patients in the SDD group treated with ASA had a good modified Rankin scale score (P = 0.01). At 12 months, no significant difference in outcome measurements was seen for all PI and AC types.
CONCLUSIONS


In patients treated with PI or AC, the insertion of SPD after burr-hole drainage of cSDH showed comparable recurrence, mortality, and long term outcome rates when compared with SDD.",2020,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","['133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial', 'After Burr-hole Drainage Under Blood Thinners']","['Subperiosteal versus Subdural Drain', 'ASA', 'subperiosteal drain (SPD) and subdural drain (SDD', 'cSDH-Drain RCT', 'platelet inhibitors (PI) or anticoagulants (AC']","['good modified Rankin scale score', 'Glasgow Coma Scale score', 'recurrence, mortality', 'recurrence rates, mortality', 'mortality', 'recurrence rates', 'recurrence rates, clinical outcome, and mortality', 'drain type and recurrence rate or mortality']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",220.0,0.201965,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kamenova', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lutz', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland; Department of Neurosurgery, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schaedelin', 'Affiliation': 'Clinical Trial Unit, University of Basel, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jehuda', 'Initials': 'J', 'LastName': 'Soleman', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland. Electronic address: jehuda.soleman@gmail.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.134']
2109,32452588,"A Phase II, Single-Arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma.","LESSONS LEARNED


This trial evaluating a novel plant extract, PBI-05204, did not meet its primary endpoint of overall survival but did show signals of efficacy in heavily pretreated mPDA. PBI-05204 was generally well tolerated, with the most common side effects related to treatment being vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%), and diarrhea (15.8%). Additional trials are needed to explore the role of PBI-05204 in cancer treatment.
BACKGROUND


Survival for metastatic pancreatic ductal adenocarcinoma (mPDA) is dismal, and novel agents are needed. PBI-05204 is a modified supercritical carbon dioxide extract of Nerium oleander leaves. Oleandrin, the extract's major cytotoxic component, is a cardiac glycoside that has demonstrated antitumor activity in various tumor cell lines with a mechanism involving inhibition of Akt phosphylation and through downregulation of mTOR.
METHODS


A phase II, single-arm, open-label study to determine the efficacy of PBI-05204 in patients with refractory mPDA therapy was conducted. The primary endpoint was overall survival (OS), with the hypothesis that 50% of patients would be alive at 4.5 months. Secondary objectives included safety, progression-free survival (PFS), and overall response rate. Patients received oral PBI-05204 daily until progressive disease (PD), unacceptable toxicity, or patient withdrawal. Radiographic response was assessed every two cycles.
RESULTS


Forty-two patients were enrolled, and 38 were analyzed. Ten patients were alive at 4.5 months (26.3%) with a median PFS of 56 days. One objective response (2.6%) was observed for 162 days. Grade ≥ 3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
CONCLUSION


PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate a role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy and radiotherapy. A randomized phase II trial is currently being designed.",2020,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","['patients with refractory mPDA therapy was conducted', 'metastatic pancreatic ductal adenocarcinoma (mPDA', 'Forty-two patients were enrolled, and 38 were analyzed', 'Patients with Stage IV Metastatic Pancreatic Adenocarcinoma']","['PBI-05204', 'chemotherapy and radiotherapy', 'Oleandrin']","['diarrhea', 'fatigue, vomiting, nausea, decreased appetite, and diarrhea', 'overall survival', 'Radiographic response', 'vomiting', 'Grade ≥', 'safety, progression-free survival (PFS), and overall response rate', 'adverse events', 'nausea', 'overall survival (OS', 'decreased appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C2987707', 'cui_str': 'PBI-05204'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0069397', 'cui_str': 'Oleandrin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0807327,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","[{'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Dana Backlund', 'Initials': 'DB', 'LastName': 'Cardin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Erkut Hasan', 'Initials': 'EH', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Steinbach', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Hospital and Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosemury', 'Affiliation': 'Florida Hospital Tampa, Tampa, Florida, USA.'}, {'ForeName': 'Raymond Couric', 'Initials': 'RC', 'LastName': 'Wadlow', 'Affiliation': 'Virginia Cancer Specialists, Fairfax, Virginia, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Newman', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0440']
2110,32452590,The Effects of Indoor Ambient Temperature at Work on Physiological Adaptation in Night Shift Nurses.,"AIM


This study examined the effects of indoor ambient temperature on thermal comfort, night work tolerance (fatigue, sleepiness, and night adaptation), and urinary melatonin in night shift nurses.
BACKGROUND


Night shift induces physical and mental stress. Night shift work and ambient temperature are associated with work performance. The working environment must be improved for successful night shift working. However, the effects of indoor ambient temperature on night shift nurses are unclear.
METHODS


In this crossover study, 20 participants were divided into two groups of 10 and were assigned to work in one of two thermo-controlled environments (23°C vs. 26℃) during two consecutive night shifts. Thermal and humidity sensation vote, night work tolerance, body temperature, and urinary melatonin were assessed.
RESULTS


There were significant differences between the two groups in thermal sensation vote and body temperature. There were no significant differences in humidity sensation vote or night work tolerance. Urinary melatonin levels decreased significantly during the second 23°C night shift.
CONCLUSION


A compensated temperature of 23°C may exert a positive effect on night shift adaptation. Implications for nursing management Nurses and nursing managers should assess their thermal comfort during night shifts, and improved thermal comfort should be provided to nurses.",2020,There were significant differences between the two groups in thermal sensation vote and body temperature.,"['nursing management Nurses and nursing managers', 'Night Shift Nurses', '20 participants']","['indoor ambient temperature', 'Indoor Ambient Temperature']","['Urinary melatonin levels', 'Thermal and humidity sensation vote, night work tolerance, body temperature, and urinary melatonin', 'thermal comfort, night work tolerance (fatigue, sleepiness, and night adaptation', 'humidity sensation vote or night work tolerance', 'thermal sensation vote and body temperature']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042978', 'cui_str': 'Voting'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",20.0,0.0098016,There were significant differences between the two groups in thermal sensation vote and body temperature.,"[{'ForeName': 'Jeong Hun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Pusan National University Hospital, Biomedical Research Institute, Busan, South Korea.'}, {'ForeName': 'Yeoungsuk', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Kyungpook National University College of Nursing, Research Institute of Nursing Science, Daegu, South Korea.'}]",Journal of nursing management,['10.1111/jonm.13052']
2111,32452641,Pilot aerobic exercise intervention for youth at-risk for serious mental illness.,"BACKGROUND


This study was conducted as a pilot exercise intervention in youth at-risk for serious mental illness (SMI). The objectives were to examine the feasibility of an exercise intervention and to determine what improvement was observed, following participation in a moderate- to high-intensity aerobic exercise programme.
METHODS


Forty-four male and female youth at-risk for SMI were recruited. Participants completed clinical, lifestyle and fitness assessments prior to and following a 16-week moderate- to high-intensity aerobic exercise intervention. Sixty-minute exercise sessions were held three times per week.
RESULTS


Forty-one participants completed the entire intervention and assessments; thus, the retention rate was 93.2%. Exercise participants achieved a mean of 98.3 (standard deviation (SD) 26.1) minutes/week of high-intensity and a mean of 32.8 (SD 8.7) minutes/week of moderate-intensity aerobic exercise over the course of 16 weeks. Improvements in aerobic fitness and body composition as well as reductions in anxiety and depression were observed after the exercise intervention.
CONCLUSION


Aerobic exercise is a feasible and sound intervention strategy in youth at-risk for SMI. Further research is required to expand upon these initial findings and develop knowledge of the mechanisms, optimum dose and factors that influence the efficacy of exercise.",2020,"Improvements in aerobic fitness and body composition as well as reductions in anxiety and depression were observed after the exercise intervention.
","['youth at-risk for SMI', 'youth at-risk for serious mental illness (SMI', 'youth at-risk for serious mental illness', 'Forty-four male and female youth at-risk for SMI were recruited']","['Aerobic exercise', 'Pilot aerobic exercise intervention', 'exercise intervention', 'moderate- to high-intensity aerobic exercise intervention']","['retention rate', 'aerobic fitness and body composition', 'anxiety and depression']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",44.0,0.0517004,"Improvements in aerobic fitness and body composition as well as reductions in anxiety and depression were observed after the exercise intervention.
","[{'ForeName': 'Syl', 'Initials': 'S', 'LastName': 'Corbett', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Farris', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'MacQueen', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Addington', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.'}]",Early intervention in psychiatry,['10.1111/eip.12977']
2112,32452659,"Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablet in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.","Clopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75-mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference-scaled average bioequivalence method. An open-label, randomized, 3-sequence and 3-period crossover (3×3), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high-precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of C max  and AUC 0-t  were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.",2020,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","['Fed and Fasted Conditions', 'Healthy Chinese Volunteers']","['clopidogrel hydrogen sulfate formulations', 'Clopidogrel Hydrogen Sulfate Tablet', 'Clopidogrel']","['geometric least squares mean ratios of C max  and AUC 0-t', 'Clopidogrel concentration of plasma samples', 'geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0772326', 'cui_str': 'Clopidogrel bisulfate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",66.0,0.0275802,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.804']
2113,32452691,"Stepping Up, Stepping Out: A program description and preliminary findings.","Research on the effects of restricted housing on inmate well-being indicates mild to moderate psychological effects and barriers opportunities for treatment and positive growth. Yet, there are few interventions tailored both to the needs of this high-risk population and to the institutional constraints of their environment. Given the financial and safety burdens associated with housing someone in segregation compared to the general population, correctional psychology should focus on developing programs that work. Using a prepost design, this study presents findings from a pilot investigation (N = 39) on the effects of a new, largely self-directed program (Stepping Up, Stepping Out [SUSO]) for inmates with mental and behavioral health concerns who are placed in restrictive settings. Results suggest that SUSO is associated with meaningful reductions in overall emotional distress and criminal attitudes; however, improvements in more stable criminal thinking patterns (i.e., distorted cognitions that are used to justify and support antisocial behavior; see Walters, 2012) were not observed. Overall, posttreatment working alliance was rated favorably by program participants. Demographic and preintervention comparisons between program completers and dropouts are also reported. Though preliminary findings suggest SUSO is a promising intervention for alleviating distress and aspects of criminal risk for inmates placed in restricted housing, future research should assess fidelity and engagement leading to a randomized controlled trial to determine the effectiveness of this program. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Overall, posttreatment working alliance was rated favorably by program participants.",['inmates with mental and behavioral health concerns who are placed in restrictive settings'],"['SUSO', 'new, largely self-directed program (Stepping Up, Stepping Out [SUSO']",['overall emotional distress and criminal attitudes'],"[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0623546,"Overall, posttreatment working alliance was rated favorably by program participants.","[{'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Batastini', 'Affiliation': 'School of Psychology, University of Southern Mississippi.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Lester', 'Affiliation': 'School of Psychology, University of Southern Mississippi.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychology, Texas Tech University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Atterberry', 'Affiliation': 'Corizon Health, Inc.'}]",Psychological services,['10.1037/ser0000430']
2114,32452814,The Personal Health Network Mobile App for Chemotherapy Care Coordination: Qualitative Evaluation of a Randomized Clinical Trial.,"BACKGROUND


Cancer care coordination addresses the fragmented and inefficient care of individuals with complex care needs. The complexity of care coordination can be aided by innovative technology. Few examples of information technology-enabled care coordination exist beyond the conventional telephone follow-up. For this study, we implemented a custom-designed app, the Personal Health Network (PHN)-a Health Insurance Portability and Accountability Act-compliant social network built around a patient to enable patient-centered health and health care activities in collaboration with clinicians, care team members, caregivers, and others designated by the patient. The app facilitates a care coordination intervention for patients undergoing chemotherapy.
OBJECTIVE


This study aimed to understand patient experiences with PHN technology and assess their perspectives on the usability and usefulness of PHNs with care coordination during chemotherapy.
METHODS


A two-arm randomized clinical trial was conducted to compare the PHN and care coordination with care coordination alone over a 6-month period beginning with the initiation of chemotherapy. A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting. All participants in the intervention arm were interviewed on completion of the study. Interviews were recorded and transcribed verbatim. A summative thematic analysis was completed for the transcribed interviews. Features of the app were also evaluated.
RESULTS


A total of 27 interviews were completed. The resulting themes included the care coordinator as a partner in care, learning while sick, comparison of other technology to make sense of the PHN, communication, learning, usability, and usefulness. Users expressed that the nurse care coordinators were beneficial to them because they helped them stay connected to the care team and answered their questions. They shared that the mobile app gave them access to the health information they were seeking. Users expressed that the mobile app would be more useful if it was fully integrated with the electronic health record.
CONCLUSIONS


The findings highlight the value of care coordination from the perspectives of cancer patients undergoing chemotherapy and the important role of technology, such as the PHN, in enhancing this process by facilitating better communication and access to information regarding their illness.",2020,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","['cancer patients undergoing', 'patients undergoing chemotherapy']","['chemotherapy', 'care coordination intervention']",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],27.0,0.0497466,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ngo', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Matsumoto', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Joseph', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Bell', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bold', 'Affiliation': 'Comprehensive Cancer Center, University of California Davis Health, Sacramento, CA, United States.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Washington State University College of Nursing - Vancouver, Vancouver, WA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division of Social Work, California State University Sacramento, Sacramento, CA, United States.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Kim', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16527']
2115,32452817,A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory.,"BACKGROUND


Mobile health (mHealth) apps offer great opportunities to deliver large-scale, cost-efficient digital solutions for implementing lifestyle changes. Furthermore, many mHealth apps act as medical devices. Yet, there is little research on how to assess user satisfaction with an mHealth solution.
OBJECTIVE


This study presents the development of the mHealth Satisfaction Questionnaire and evaluates its measurement properties.
METHODS


Respondents who took part in the Health Integrator Study and were randomized to use the Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching, rated their satisfaction with the app using the new 14-item mHealth Satisfaction Questionnaire. The ratings were given on a 5-point Likert scale and measurement properties were evaluated using Rasch measurement theory (RMT).
RESULTS


Optimal scoring was reached when response options 2, 3, and 4 were collapsed, giving three response categories. After omitting two items that did not fit into the scale, fit residuals were within, or close to, the recommended range of ±2.5. There was no differential item functioning between intervention group, age group, or sex. The Person Separation Index was 0.79, indicating that the scale's ability to discriminate correctly between person leniency was acceptable for group comparisons but not for individual evaluations. The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96. In addition, several items showed local dependency and three underlying dimensions emerged: negative experiences, positive experiences, and lifestyle consequences of using the mHealth solution.
CONCLUSIONS


In times where mHealth apps and digital solutions are given more attention, the mHealth Satisfaction Questionnaire provides a new possibility to measure user satisfaction to ensure usability and improve development of new apps. Our study is one of only a few cases where RMT has been used to evaluate the usability of such an instrument. There is, though, a need for further development of the mHealth Satisfaction Questionnaire, including the addition of more items and consideration of further response options. The mHealth Satisfaction Questionnaire should also be evaluated in a larger sample and with other mHealth apps and in other contexts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03579342; http://clinicaltrials.gov/ct2/show/NCT03579342.",2020,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"['Respondents who took part in the Health Integrator Study', 'Mobile Health Apps']","['Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching']",['Person Separation Index'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0311165,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Melin', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Stephanie Erika', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Pendrill', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/15909']
2116,32452818,Assessment of the Efficacy of a Mobile Phone-Delivered Just-in-Time Planning Intervention to Reduce Alcohol Use in Adolescents: Randomized Controlled Crossover Trial.,"BACKGROUND


Interventions to reduce alcohol use typically include several elements, such as information on the risks of alcohol consumption, planning for sensible drinking, and training of protective behavioral strategies. However, the effectiveness of these individual intervention elements within comprehensive programs has not been addressed so far, but it could provide valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices are intended to help people make healthy decisions in the moment and thus could influence health behavior.
OBJECTIVE


The aim of this study was to test the proximal effects of a mobile phone-delivered, just-in-time planning intervention to reduce alcohol use in adolescents who reported recent binge drinking. The efficacy of this individual intervention element was tested within a comprehensive intervention program to reduce problem drinking in adolescents.
METHODS


The study had an AB/BA crossover design, in which participants were randomly allocated to (1) a group receiving the planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention (A) in period 2. The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan. There was a washout period of at least 1 week between period 1 and period 2.
RESULTS


Out of 633 program participants who recently binge drank, 136 (21.5%) were receptive in both periods of time and provided data on the proximal outcome, which was the number of alcoholic drinks consumed with friends or when going out. After the planning intervention, the number of alcoholic drinks consumed was approximately one standard drink lower compared with the finding without the intervention (P=.01).
CONCLUSIONS


A mobile phone-delivered, just-in-time, if-then planning intervention to practice sensible drinking with friends or when going out is effective in reducing alcohol consumption among adolescents who report recent binge drinking. Based on the relatively low percentage of participants with self-reported receptivity for the planning intervention, measures to increase the population impact of similar planning interventions should be implemented and tested in future trials.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN52150713; http://www.isrctn.com/ISRCTN52150713.",2020,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"['Adolescents', 'Out of 633 program participants who recently binge drank, 136 (21.5', 'adolescents who report recent binge drinking', 'adolescents who reported recent binge drinking', 'adolescents']","['mobile phone-delivered, just-in-time planning intervention', 'Mobile Phone-Delivered Just-in-Time Planning Intervention', 'planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention']",['number of alcoholic drinks'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]",633.0,0.048824,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"[{'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Paz Castro', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Applied Social and Health Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Center for Digital Health Interventions, Institute of Technology Management, University of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Michael Patrick', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Radtke', 'Affiliation': 'Health, Work & Organizational Psychology, School of Psychology and Psychotherapy, Witten/Herdecke University, Witten/Herdecke, Germany.'}]",JMIR mHealth and uHealth,['10.2196/16937']
2117,32452846,Cardiogenic shock: role of invasive cardiology.,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI). Nevertheless, the mortality remains substantial, ranging between 40 and 50% after 30 days. The present review summarizes the current evidence regarding revascularization strategies, vascular access site and concomitant antiplatelet and antithrombotic treatment in infarct-related cardiogenic shock.
RECENT FINDINGS


On the basis of the SHOCK trial, early revascularization is the most relevant procedure to improve the outcome of patients with infarct-related cardiogenic shock. The majority of these patients present with multivessel coronary disease. The randomized CULPRIT-SHOCK trial showed that in the emergency setting, percutaneous coronary intervention (PCI) should be confined to the culprit lesion. Regarding vascular access site, no data derived from randomized controlled trials in cardiogenic shock are available. Emergency coronary artery bypass grafting (CABG) is nowadays rarely performed in cardiogenic shock with rates less than 5% but is still a treatment option if coronary anatomy is not amenable to PCI. Regarding antiplatelet treatment, a randomized trial testing the intravenous P2Y12 inhibitor cangrelor versus an oral P2Y12 inhibitor in infarct-related cardiogenic shock is currently being performed.
SUMMARY


Early revascularization is the cornerstone of treatment of infarct-related cardiogenic shock and should be confined to the culprit lesion in the emergency setting.",2020,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","['patients with cardiogenic shock following acute myocardial infarction (AMI', 'patients with infarct-related cardiogenic shock']","['percutaneous coronary intervention (PCI', 'Emergency coronary artery bypass grafting (CABG', 'intravenous P2Y12 inhibitor cangrelor']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1532296', 'cui_str': 'Emergency CABG'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}]",[],,0.1286,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}]",Current opinion in critical care,['10.1097/MCC.0000000000000738']
2118,32452896,Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness.,"BACKGROUND


Imprecise interpretation of coronary angiograms was reported and resulted in inappropriate revascularization. Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a comprehensive system to evaluate the complexity of the overall lesions. We hypothesized that a real-time SYNTAX score feedback from image analysts may rectify the mis-estimation and improve revascularization appropriateness in patients with stable coronary artery disease (CAD).
METHODS


In this single-center, historical control study, patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited. During the control period, SYNTAX scores were calculated by treating cardiologists. During the intervention period, SYNTAX scores were calculated by image analysts immediately after coronary angiography and were provided to cardiologists in real-time to aid decision-making. The primary outcome was revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization.
RESULTS


A total of 3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n = 1525) or the intervention group (03/2017-09/2017, n = 1720). For SYNTAX score tertiles, 17.9% patients were overestimated and 4.3% were underestimated by cardiologists in the control group. After adjustment, inappropriate revascularization significantly decreased in the intervention group compared with the control group (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.73-0.95; P = 0.007). Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group. There was no significant difference in 1-year adverse cardiac events between the control group and the intervention group.
CONCLUSIONS


Real-time SYNTAX score feedback significantly reduced inappropriate coronary revascularization in stable patients with CAD.
CLINICAL TRIAL REGISTRATION


Nos. NCT03068858 and NCT02880605; https://www.clinicaltrials.gov.",2020,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"['patients with stable coronary artery disease (CAD', 'stable patients with CAD', 'patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited', '3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n\u200a=\u200a1525) or the intervention group (03/2017-09/2017, n\u200a=\u200a1720']","['Real-time SYNTAX score feedback', 'Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score']","['revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization', 'percutaneous coronary intervention utilization', 'inappropriate revascularization', 'inappropriate coronary revascularization', '1-year adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517603', 'cui_str': '1720'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",3245.0,0.104042,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Si-Peng', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Department of Information Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chen-Fei', 'Initials': 'CF', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fa-Jun', 'Initials': 'FJ', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Hong-Bing', 'Initials': 'HB', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Ke-Fei', 'Initials': 'KF', 'LastName': 'Dou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yi-Da', 'Initials': 'YD', 'LastName': 'Tang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Xie', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chang-Dong', 'Initials': 'CD', 'LastName': 'Guan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000827']
2119,32452923,"The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial.","OBJECTIVES


To compare the efficacy of intense pulsed light (IPL) combined with Meibomian gland expression (MGX), and instant warm compresses combined with MGX, for treatment of dry eye disease (DED) due to meibomian gland dysfunction (MGD).
METHODS


In a prospective, multicenter, interventional study, 120 subjects with DED due to MGD were randomized 1:1 to an IPL arm or a control arm. Each subject was treated 3 times at 3-week intervals. The primary outcome measure was the tear break up time (TBUT). Tear break up time and a few additional outcome measures were evaluated at the baseline and at 3 weeks after the last treatment.
RESULTS


All outcome measures improved in both arms, but in general, the improvement was significantly larger in the IPL arm. Tear break up time increased by 2.3±1.9 and 0.5±1.4 sec, in the IPL and control arms respectively (P<0.001). SPEED was reduced by 38% and 22% in the IPL and control arms, respectively (P<0.01). Meibomian Gland Yielding Secretion Score was improved by 197% in the IPL arm and 96% in the control arm. Corneal fluorescein staining also decreased by 51% and 24% in the IPL and control arms respectively, but the differences between the two arms were not statistically significant (P=0.61). A composite score of lid margin abnormalities improved in both arms, but more in the IPL arm (P<0.05).
CONCLUSIONS


Intense pulsed light combined with MGX therapy was significantly more effective than instant warm compresses followed with MGX. This suggests that the IPL component has a genuine contribution to the improvement of signs and symptoms of DED.",2020,"A composite score of lid margin abnormalities improved in both arms, but more in the IPL arm (P<0.05).
","['Dry Eye Disease', '120 subjects with DED due to MGD', 'Meibomian Gland Dysfunction']","['MGX therapy', 'IPL', 'Intense Pulsed Light Combined With Meibomian Gland Expression', 'intense pulsed light (IPL) combined with Meibomian gland expression (MGX), and instant warm compresses combined with MGX']","['Tear break up time', 'lid margin abnormalities', 'tear break up time (TBUT', 'Meibomian Gland Yielding Secretion Score', 'Corneal fluorescein staining', 'SPEED']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",120.0,0.0742957,"A composite score of lid margin abnormalities improved in both arms, but more in the IPL arm (P<0.05).
","[{'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Ophthalmology (X.Y., B.R., W.S., Y.C.), Peking University First Hospital, Beijing, China; Department of Ophthalmology (J.H., Y.F.), Peking University Third Hospital. Beijing, China; Eye Center (X.J., X.H., L.L.), Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; and The School of Ophthalmology and Optometry and Eye Hospital (W.C., J.L.), Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Xiuming', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Bein', 'Initials': 'B', 'LastName': 'Rong', 'Affiliation': ''}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Jinyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000711']
2120,32452928,"Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees.","BACKGROUND


Targeted muscle reinnervation is an emerging surgical technique to treat neuroma pain whereby sensory and mixed motor nerves are transferred to nearby redundant motor nerve branches. In a recent randomized controlled trial, targeted muscle reinnervation was recently shown to reduce postamputation pain relative to conventional neuroma excision and muscle burying.
QUESTIONS/PURPOSES


(1) Does targeted muscle reinnervation improve residual limb pain and phantom limb pain in the period before surgery to 1 year after surgery? (2) Does targeted muscle reinnervation improve Patient-reported Outcome Measurement System (PROMIS) pain intensity and pain interference scores at 1 year after surgery? (3) After 1 year, does targeted muscle reinnervation improve functional outcome scores (Orthotics Prosthetics User Survey [OPUS] with Rasch conversion and Neuro-Quality of Life [Neuro-QOL])?
METHODS


Data on patients who were ineligible for randomization or declined to be randomized and underwent targeted muscle reinnervation for pain were gathered for the present analysis. Data were collected prospectively from 2013 to 2017. Forty-three patients were enrolled in the study, 10 of whom lacked 1-year follow-up, leaving 33 patients for analysis. The primary outcomes measured were the difference in residual limb and phantom limb pain before and 1 year after surgery, assessed by an 11-point numerical rating scale (NRS). Secondary outcomes were change in PROMIS pain measures and change in limb function, assessed by the OPUS Rasch for upper limbs and Neuro-QOL for lower limbs before and 1 year after surgery.
RESULTS


By 1 year after targeted muscle reinnervation, NRS scores for residual limb pain from 6.4 ± 2.6 to 3.6 ± 2.2 (mean difference -2.7 [95% CI -4.2 to -1.3]; p < 0.001) and phantom limb pain decreased from 6.0 ± 3.1 to 3.6 ± 2.9 (mean difference -2.4 [95% CI -3.8 to -0.9]; p < 0.001). PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference -9.0 [95% CI -14.0 to -4.0]; residual limb pain interference: 60.4 ± 9.3 to 51.7 ± 8.2, mean difference -8.7 [95% CI -13.1 to -4.4]; phantom limb pain intensity: 49.3 ± 10.4 to 43.2 ± 9.3, mean difference -6.1 [95% CI -11.3 to -0.9]; phantom limb pain interference: 57.7 ± 10.4 to 50.8 ± 9.8, mean difference -6.9 [95% CI -12.1 to -1.7]; p ≤ 0.012 for all comparisons). On functional assessment, OPUS Rasch scores improved from 53.7 ± 3.4 to 56.4 ± 3.7 (mean difference +2.7 [95% CI 2.3 to 3.2]; p < 0.001) and Neuro-QOL scores improved from 32.9 ± 1.5 to 35.2 ± 1.6 (mean difference +2.3 [95% CI 1.8 to 2.9]; p < 0.001).
CONCLUSIONS


Targeted muscle reinnervation demonstrates improvement in residual limb and phantom limb pain parameters in major limb amputees. It should be considered as a first-line surgical treatment option for chronic amputation-related pain in patients with major limb amputations. Additional investigation into the effect on function and quality of life should be performed.
LEVEL OF EVIDENCE


Level IV, therapeutic study.",2020,"PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference","['patients with major limb amputations', 'Data on patients who were ineligible for randomization or declined to be randomized and underwent targeted muscle reinnervation for pain were gathered for the present analysis', 'Forty-three patients were enrolled in the study, 10 of whom lacked 1-year follow-up, leaving 33 patients for analysis', '33 Major Limb Amputees', 'major limb amputees']",[],"['phantom limb pain', 'residual limb pain interference', 'PROMIS pain intensity and pain interference scores', 'phantom limb pain interference', 'Neuro-QOL scores', 'residual limb pain and phantom limb pain', 'muscle reinnervation improve Patient-reported Outcome Measurement System (PROMIS) pain intensity and pain interference scores', 'residual limb and phantom limb pain parameters', 'functional assessment, OPUS Rasch scores', 'Residual Limb Pain, Phantom Limb Pain, and Limb Function', 'change in PROMIS pain measures and change in limb function, assessed by the OPUS Rasch for upper limbs and Neuro-QOL for lower limbs', 'targeted muscle reinnervation improve functional outcome scores (Orthotics Prosthetics User Survey [OPUS] with Rasch conversion and Neuro-Quality of Life [Neuro-QOL', 'function and quality of life', 'residual limb and phantom limb pain before and 1 year after surgery, assessed by an 11-point numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191671', 'cui_str': 'Targeted muscle reinnervation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",[],"[{'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C5191671', 'cui_str': 'Targeted muscle reinnervation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",43.0,0.349661,"PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mioton', 'Affiliation': 'L. M. Mioton, G. A. Dumanian, N. Shah, C. S. Qiu, J. H. Ko, S. W. Jordan, Division of Plastic and Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA W. J. Ertl, The Department of Orthopedic Surgery, The University of Oklahoma, Oklahoma City, OK, USA B. K. Potter, J. M. Souza, Department of Surgery, Walter Reed National Military Medical Center, Uniformed Services University of Health Sciences, Bethesda, MD, USA I. L. Valerio, The Department of Plastic Surgery, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Dumanian', 'Affiliation': ''}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Cecil S', 'Initials': 'CS', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ertl', 'Affiliation': ''}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Valerio', 'Affiliation': ''}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Sumanas W', 'Initials': 'SW', 'LastName': 'Jordan', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001323']
2121,32452960,"Vitamin D, melanoma risk, and tumor thickness in PLCO cancer screening trial patients.","OBJECTIVE


The incidence of melanoma is increasing. Other than limiting UV exposure, few factors prevent or reduce the risk of melanoma. The aim of this study is to evaluate the relationship between vitamin D intake and melanoma risk in the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial.
METHODS


A secondary data analysis was performed on PLCO data. More than 1,300 participants developed melanoma.
RESULTS


Melanoma risk may be increased among men within the highest quartile of vitamin D intake (HR 1.27, 95% CI 0.99, 1.61). Women in the highest quartile of vitamin D intake had a decreased risk of invasive melanoma (HR 0.63, 95% CI 0.41, 0.96). Higher education and being white corresponded with deeper tumors (P < .001).
CONCLUSION


High reported vitamin D intake resulted in an increased risk of melanoma among men. Vitamin D intake yielded a protective effect against invasive melanoma in women.",2020,"Women in the highest quartile of vitamin D intake had a decreased risk of invasive melanoma (HR 0.63, 95% CI 0.41, 0.96).","['1,300 participants developed melanoma', 'PLCO cancer screening trial patients', 'women']","['High reported vitamin D intake', 'Vitamin D intake']","['Vitamin D, melanoma risk, and tumor thickness', 'risk of invasive melanoma', 'vitamin D intake', 'risk of melanoma']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",,0.693457,"Women in the highest quartile of vitamin D intake had a decreased risk of invasive melanoma (HR 0.63, 95% CI 0.41, 0.96).","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hyde', 'Affiliation': 'At the University of Utah Health Sciences Center in Salt Lake City, Mark A. Hyde is an assistant professor of dermatology at the Huntsman Cancer Institute and an assistant professor in the department of community and public health at Utah Valley University, Douglas Grossman is a professor in the Department of Dermatology and codirector of the melanoma and cutaneous oncology program at the Huntsman Cancer Institute, Yelena P. Wu is an assistant professor in the Department of Dermatology, Saundra Buys is a professor in the Department of Medicine and medical director of the High Risk Breast Cancer Clinic at the Huntsman Cancer Institute, Lisa H. Gren is an associate professor in the Department of Family and Preventive Medicine, and Mia Hashibe is an associate professor in the Department of Family and Preventive Medicine and at the Huntsman Cancer Institute. This work was supported by the National Cancer Institute (NCI) of the National Institutes of Health (K07CA196985). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or NCI. The authors have disclosed no other potential conflicts of interest, financial or otherwise.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': ''}, {'ForeName': 'Yelena P', 'Initials': 'YP', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Saundra', 'Initials': 'S', 'LastName': 'Buys', 'Affiliation': ''}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Gren', 'Affiliation': ''}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Hashibe', 'Affiliation': ''}]",JAAPA : official journal of the American Academy of Physician Assistants,['10.1097/01.JAA.0000662388.18867.42']
2122,32452969,"Performance of Male Condoms when Used With and Without a Silicone Placebo Vaginal Ring - A Randomized, Crossover Trial.","BACKGROUND


The Dapivirine Vaginal Ring, reduces the risk of HIV infection by approximately 30-50% depending on adherence to ring use. To ensure higher levels of protection against HIV and sexually transmitted infections (STIs) women should be counselled to use condoms when using the vaginal ring. This paper evaluates the compatibility of male condoms with a placebo vaginal ring.
METHODS


This was a two-period crossover, randomized non-inferiority trial. Couples in two sites in the United States of America were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use four male condoms in each period. The primary non-inferiority endpoints were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the two periods using the male condom without the ring as reference. Non-inferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed.
RESULTS


Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% CI: -5.3%; 1.5%), thereby demonstrating non-inferiority when used with the ring. There was no difference in safety between the two periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on male condom functionality or safety outcomes.",2020,"There was no difference in safety between the two periods.
","['Couples in two sites in the United States of America', 'Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period', 'male condoms with a placebo vaginal ring']","['Silicone Placebo', 'placebo silicone vaginal ring']","['risk of HIV infection', 'Total condom clinical failure rates', 'safety', 'total clinical failure and their component failure events (clinical breakage or slippage', 'male condom functionality or safety outcomes', 'Safety and acceptability']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",275.0,0.452772,"There was no difference in safety between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health. 3600 Wilshire Boulevard, Suite 600, Los Angeles, California, 90010 United States of America.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health. 3600 Wilshire Boulevard, Suite 600, Los Angeles, California, 90010 United States of America.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002397']
2123,32452973,"Performance and Acceptability of the FC2 Female Condom® when Used With and Without a Silicone Placebo Vaginal Ring - A Randomized, Crossover Trial.","BACKGROUND


The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring.
METHODS


This was a two-period crossover, randomized non-inferiority trial. Couples in two sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use four female condoms in each period. The primary non-inferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the two periods, using the female condom without the ring as reference. Non-inferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed.
RESULTS


Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% CI: -7.8%; 3.6%), thereby demonstrating non-inferiority when used with the ring. There were no differences in safety and tolerability between the two periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes.",2020,"There were no differences in safety and tolerability between the two periods.
","['female condoms with the ring', 'Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively', 'Couples in two sites in the United States of America', 'women']","['FC2 Female Condom®', 'FC2 Female Condom (FC2) with and without a placebo silicone', 'placebo silicone vaginal ring']","['Total female condom clinical failure', 'Safety and tolerability', 'safety and tolerability', 'female condom functionality or safety outcomes', 'clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection and invagination', 'Performance and Acceptability']","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0221224', 'cui_str': 'Invagination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",81.0,0.391157,"There were no differences in safety and tolerability between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, 8405 Colesville Road, Suite 600, Silver Spring, Maryland 20910, United States of America.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health. 3600 Wilshire Boulevard, Suite 600, Los Angeles, California, 90010 United States of America.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health. 3600 Wilshire Boulevard, Suite 600, Los Angeles, California, 90010 United States of America.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002408']
2124,32453116,Goal Attainment Scaling Rehabilitation Improves Satisfaction with Work Activities for Younger Working Patients After Knee Arthroplasty: Results from the Randomized Controlled ACTION Trial.,"BACKGROUND


Knee arthroplasty (KA) is increasingly performed in relatively young, active patients. This heterogeneous patient population often has high expectations, including work resumption and performance of knee-demanding leisure-time activities. Goal attainment scaling (GAS) may personalize rehabilitation by using patient-specific, activity-oriented rehabilitation goals. Since unmet expectations are a leading cause of dissatisfaction after KA, personalized rehabilitation may improve patient satisfaction. We hypothesized that, compared with standard rehabilitation, GAS-based rehabilitation would result in younger, active patients having higher satisfaction regarding activities after KA.
METHODS


We performed a single-center randomized controlled trial. Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA. The required sample size was 120 patients. Using GAS, patients developed personal activity goals with a physiotherapist preoperatively. These goals were used to monitor patients' goal attainment and provide goal-specific feedback during postoperative outpatient rehabilitation. Standard rehabilitation consisted of regular outpatient physiotherapy visits. The primary outcome measures were visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively, which were analyzed using generalized estimating equation models.
RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group. Patient satisfaction with activities of daily living and leisure-time activities did not differ between groups. We found no differences in VAS satisfaction scores between unicompartmental KA and total KA.
CONCLUSIONS


Personalized, goal-specific rehabilitation using GAS resulted in higher patient satisfaction with work activities, compared with standard rehabilitation, 1 year after KA.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","['Younger Working Patients', 'After Knee Arthroplasty', 'relatively young, active patients', 'Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA']","['Knee arthroplasty (KA', 'Goal Attainment Scaling Rehabilitation', 'regular outpatient physiotherapy visits', 'standard rehabilitation, GAS-based rehabilitation']","['Patient satisfaction with activities of daily living and leisure-time activities', 'VAS satisfaction scores', 'visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively', 'Patient satisfaction with work activities', 'personal activity goals']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",120.0,0.240302,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoorntje', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Waterval-Witjes', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Koen L M', 'Initials': 'KLM', 'LastName': 'Koenraadt', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'P Paul F M', 'Initials': 'PPFM', 'LastName': 'Kuijer', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Blankevoort', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutger C I', 'Initials': 'RCI', 'LastName': 'van Geenen', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01471']
2125,32453139,"Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.","This randomized, double-blind, Phase 3 study (56-week treatment; 24-week follow-up) assessed tanezumab in patients with chronic low back pain (CLBP) and history of inadequate response to standard-of-care analgesics (NCT02528253). Patients received placebo, subcutaneous tanezumab (5mg or 10mg every 8 weeks), or oral tramadol prolonged-release (100-300mg/day). Primary endpoint was change in Low Back Pain Intensity (LBPI) at week 16 for tanezumab versus placebo. Key secondary endpoints were proportion of patients with ≥50% decrease in LBPI at week 16, change in Roland Morris Disability Questionnaire (RMDQ) at week 16, and change in LBPI at week 2 for tanezumab versus placebo. Adverse events and joint safety were assessed through weeks 56 and 80, respectively. Tanezumab 10mg met the primary endpoint by significantly improving LBPI at week 16 versus placebo; least squares (LS) mean (95% CI) difference = -0.40 (-0.76, -0.04; P=0.0281). Tanezumab 10mg significantly improved all key secondary endpoints. Tanezumab 5mg did not meet the primary endpoint (LS mean [95% CI] treatment difference versus placebo = -0.30 [-0.66, 0.07; P=0.1117]), preventing formal testing of key secondary endpoints for this dose. The proportion of patients with ≥50% improvement in LBPI at week 16 was 37.4% in the placebo group, 43.3% in the tanezumab 5mg group (Odds ratio [95% CI] vs placebo = 1.28 [0.97, 1.70; P=0.0846]) and 46.3% in the tanezumab 10mg group (Odds ratio [95% CI] vs placebo = 1.45 [1.09, 1.91; P=0.0101]). Prespecified joint safety events were more frequent with tanezumab 10mg (2.6%) than tanezumab 5mg (1.0%), tramadol (0.2%), or placebo (0%). Seven patients, all in the tanezumab 10mg group (1.4%), underwent total joint replacement. In conclusion, tanezumab 10mg significantly improved pain and function versus placebo in patients with difficult-to-treat CLBP. Tanezumab was associated with a low rate of joint safety events, some requiring joint replacement. Sponsored by Pfizer Inc. and Eli Lilly & Company.",2020,Tanezumab 5mg did not meet the primary endpoint (LS mean [95% CI] treatment difference versus placebo = -0.30,"['patients with chronic low back pain (CLBP) and history of inadequate response to standard-of-care analgesics (NCT02528253', 'chronic low back pain', 'patients with difficult-to-treat CLBP']","['Tanezumab', 'tramadol', 'placebo, subcutaneous tanezumab', 'tanezumab', 'placebo']","['LBPI', 'Roland Morris Disability Questionnaire (RMDQ', 'Low Back Pain Intensity (LBPI', 'pain and function', 'low rate of joint safety events', 'Adverse events and joint safety', 'efficacy and safety', 'Prespecified joint safety events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.615278,Tanezumab 5mg did not meet the primary endpoint (LS mean [95% CI] treatment difference versus placebo = -0.30,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Markman', 'Affiliation': 'Department of Neurosurgery, University of Rochester Medical Center, Rochester, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Bolash', 'Affiliation': 'Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Boston, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pombo-Suarez', 'Affiliation': 'Rheumatology Service, Hospital Clinico Universitario Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ohtori', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Boston University, Boston, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc., Collegeville, USA (at time of study, current affiliation is Eisai Inc, Woodcliff Lake, USA).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly & Company, Indianapolis, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Bramson', 'Affiliation': 'Pfizer Inc., Groton, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc., Groton, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc., Groton, USA.'}]",Pain,['10.1097/j.pain.0000000000001928']
2126,32453167,Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND


For endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anaesthesia, both rigid bronchoscopy and laryngeal masks (LMAs) with superimposed high-frequency jet ventilation can be used. Despite the fact that in Europe rigid bronchoscopy for EBUS-TBNA is still widely used, an increasing number of centres use jet ventilation via the LMA for this procedure. To our knowledge no clinical trials have ever been made to compare these two methods. This trial aimed to evaluate whether patients recover from the procedure more quickly when a LMA is used for ventilation compared with rigid bronchoscopy where muscle relaxants and deep anaesthesia are required.
OBJECTIVES


We wanted to test the hypothesis that there is no difference in the postoperative recovery of patients in the postanaesthesia care unit (PACU) after EBUS-TBNA with jet ventilation via a rigid bronchoscope and a LMA. Secondary outcomes were the difference of duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups.
DESIGN


Prospective randomised single blinded two centre controlled trial.
SETTING


Two centres in Austria participated. Patients were enrolled from December 2016 until January 2018.
PATIENTS


Ninety patients for elective EBUS-TBNA were enrolled and assigned to one of two intervention groups. Two patients were excluded before and eleven patients were excluded after EBUS-TBNA. Seventy-seven were analysed.
INTERVENTIONS


Patients assigned to group 1 were ventilated with a LMA; those assigned to group 2 were ventilated via a rigid bronchoscope. Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU were recorded.
MAIN OUTCOME MEASURES


The primary endpoint was an integral over time of a modified Aldrete score. Secondary endpoints were the durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome.
RESULTS


We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes. Vital signs remained stable and in an equal range in both groups. There were no differences in the mean effect site propofol concentration and the peak ultiva rates.
CONCLUSION


EBUS-TBNA under general anaesthesia using a LMA with SHJV is equal to rigid bronchoscopy with superimposed high-frequency jet ventilation for the variables analysed.
TRIAL REGISTRATION


ISRCTN (ISRCTN58911367).",2020,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","['Patients were enrolled from December 2016 until January 2018', 'Seventy-seven were analysed', 'Ninety patients for elective EBUS-TBNA', 'Two patients were excluded before and eleven patients were excluded after EBUS-TBNA', 'Two centres in Austria participated']","['ventilated via a rigid bronchoscope', 'endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'LMA with SHJV', 'endobronchial ultrasound-guided transbronchial needle aspiration', 'Infraglottic versus supraglottic jet-ventilation', 'LMA']","['Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU', 'mean effect site propofol concentration and the peak ultiva rates', 'integral over time of a modified Aldrete score', 'durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome', 'duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0594510', 'cui_str': 'Ultiva'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",2.0,0.127212,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fritze', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Base', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wasserscheid', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Wolfram', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Koinig', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hackner', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lambers', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schweiger', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Errhalt', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}, {'ForeName': 'Mir A', 'Initials': 'MA', 'LastName': 'Hoda', 'Affiliation': 'From the Division of Cardiothoracic and Vascular Anaesthesia, Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna (MA, EB TW), Faculty of Computer Science, Research Group Data Mining, University of Vienna, Vienna (RF), Department of Anaesthesia and Intensive Care Medicine (RF, NW, HK), Department of Pneumonology, Karl Landsteiner University of Health Sciences, Krems (KH, PE) and Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria (CL, TS, MAH).'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001220']
2127,32453168,Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial.,"BACKGROUND


Ultrasound has increased the efficacy of femoral nerve catheters but their postoperative dislocation still remains a common problem. Although catheter placement parallel to the nerve seems to reduce dislocation rates in other nerves and plexuses, the possible advantage for femoral nerve catheter placement remains unclear.
OBJECTIVE


To compare the dislocation rates of femoral catheters when placed perpendicular or parallel to the femoral nerve.
DESIGN


Randomised controlled study.
SETTING


University orthopaedic hospital. Duration of study: October 2018 to June 2019.
PATIENTS


Eighty patients scheduled for major knee surgery with femoral catheter were enrolled and randomly allocated in two groups. Data from 78 patients could be analysed.
INTERVENTIONS


The femoral nerve catheters was placed perpendicular to the nerve in Group 1 (n=40), whereas in Group 2 (n=38) parallel to it. For Group 1 the short-axis view of the nerve and an in-plane puncture was used. For Group 2 we used the short-axis view of the nerve and an out-of-plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane.
MAIN OUTCOME MEASURES


Primary outcome was the catheter dislocation rate in the first 48 h. Secondary outcomes were pain scores and sensory blockade.
RESULTS


There was no statistically significant difference between the two techniques regarding dislocation of the catheters at 24 or 48 h (at 48 h, Group 1: 15%, Group 2: 2.6%, P = 0.109). Also pain scores, sensory blockade and rescue doses of ropivacaine did not differ between the groups. However, in Group 2 the technique took longer.
CONCLUSION


Rotating the ultrasound probe to the long-axis in-plane view enabled examination of the catheter position when it was placed parallel to the nerve. The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03693755.",2020,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","['University orthopaedic hospital', '78 patients could be analysed', 'Eighty patients scheduled for major knee surgery with femoral catheter', 'Duration of study: October 2018 to June 2019']","['perineural catheters placed either perpendicular or parallel to the femoral nerve', 'ropivacaine', 'plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane']","['Dislocation rates', 'dislocation of the catheters', 'pain scores and sensory blockade', 'catheter dislocation rate', 'dislocation rates', 'pain scores, sensory blockade and rescue doses', 'dislocation rate, pain scores or sensory blockade', 'dislocation rates of femoral catheters']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",80.0,0.154648,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kalimeris', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rupnik', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Allenspach', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'Sandro F', 'Initials': 'SF', 'LastName': 'Fucentese', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Aguirre', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Eichenberger', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain Medicine (KK, BR, KA, JA, UE), Department of Orthopaedic Surgery, Balgrist University Hospital (SFF) and Department of Orthopaedic Surgery, University of Zurich, Institute for Biomechanics, ETH Zurich, Balgrist Campus, Zürich, Switzerland (TG).'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001237']
2128,32453209,Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.,"OBJECTIVE


The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.
METHODS


A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.
RESULTS


Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.
CONCLUSIONS


The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.",2020,The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001).,"['stress urinary incontinence (SUI) in females', 'Stress Urinary Incontinence', 'women diagnosed with symptomatic SUI using a self-inserted pessary device', '73 subjects were enrolled and 51 completed the study']",['Disposable Vaginal Device'],"['Safety and Efficacy', 'number of leakage episodes', 'efficacy and safety', 'average pad weight gain', 'quality of life scores', 'number of leakage events and pad weight', 'leakage volume, leakage episodes']","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1273016', 'cui_str': 'Vaginal device'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",73.0,0.0862336,The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001).,"[{'ForeName': 'Omar Felipe', 'Initials': 'OF', 'LastName': 'Duenas-Garcia', 'Affiliation': 'From the Department of Obstetrics and Gynecology, West Virginia University Medical School, Morgantown, WV.'}, {'ForeName': 'Robert Edward', 'Initials': 'RE', 'LastName': 'Shapiro', 'Affiliation': 'From the Department of Obstetrics and Gynecology, West Virginia University Medical School, Morgantown, WV.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gaccione', 'Affiliation': 'Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000861']
2129,32453223,The Intelligent Automated Pressure-Adjustable Orthosis for Patients with Adolescent Idiopathic Scoliosis (AIS): A Bi-Center Randomized Controlled Trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


To compare the effectiveness of the automated pressure-adjustable orthosis (PO) and conventional orthosis (CO) for treatment of adolescent idiopathic scoliosis (AIS).
SUMMARY OF BACKGROUND DATA


Orthosis wearing quality may influence its effectiveness for AIS. An automated PO aimed to provide a more optimized and consistent biomechanical environment. Clinical evaluation was conducted to study the effectiveness of this innovative orthosis.
METHODS


Patients with AIS who met the criteria (Age 10-14, Cobb 20°-40°, and Risser sign 0-2) were recruited from 2 clinics and randomly assigned to the PO and CO groups. Compliance sensors were embedded in both groups, while the PO group was set to adjust the interfacial pressure as prescribed automatically. Clinical assessments (radiology and quality of life, QoL) were conducted at the baseline, immediate after orthosis fitting and 1-year follow-up. Orthosis wearing compliance was tracked using thermo and pressure sensors.
RESULTS


Twenty-four patients were enrolled with one drop-out (PO, n = 11; CO, n = 12). Significant immediate in-orthosis correction was observed in the PO (11.0°±6.5°, 42.0%, p < 0.001) and CO (10.3°±5.3°, 37.6%, p < 0.001) groups. After 1 year, no patient with PO progressed while 2 with CO had progression > 5°. The mean daily wearing duration was 1.1 hours longer in the PO group as compared with the CO group (15.4 ± 4.5 vs 14.3 ± 3.8 hours). Moreover, the wearing quality within the targeted pressure was 33.9% higher in the PO group (56.5 ± 16.5% vs 23.1 ± 12.1%, p < 0.001). No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
CONCLUSION


This study showed that the automated PO could enhance wearing quality when compared with the CO, thus offering a better biomechanical corrective effect in the study period without adverse effect on the patients' wearing quantity and QoL.
LEVEL OF EVIDENCE


1.",2020,"No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
","['Patients with Adolescent Idiopathic Scoliosis (AIS', 'Patients with AIS who met the criteria (Age 10-14, Cobb 20', 'Twenty-four patients were enrolled with one drop-out (PO, n\u200a=\u200a11; CO, n\u200a=\u200a12', 'adolescent idiopathic scoliosis (AIS']","['automated pressure-adjustable orthosis (PO) and conventional orthosis (CO', 'CO']","['QoL results', 'wearing quality', 'orthosis correction', 'mean daily wearing duration', 'CO', 'Clinical assessments (radiology and quality of life, QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",24.0,0.078417,"No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
","[{'ForeName': 'Yangmin', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, PRC.'}, {'ForeName': 'Edmond Hok Ming', 'Initials': 'EHM', 'LastName': 'Lou', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Alberta, Alberta, Canada.'}, {'ForeName': 'Tsz Ping', 'Initials': 'TP', 'LastName': 'Lam', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, PRC.'}, {'ForeName': 'Jack Chun-Yiu', 'Initials': 'JC', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, PRC.'}, {'ForeName': 'Sai Wing', 'Initials': 'SW', 'LastName': 'Sin', 'Affiliation': 'Department of Prosthetics and Orthotics, Prince of Wales Hospital, Hong Kong, PRC.'}, {'ForeName': 'Wing Kwan', 'Initials': 'WK', 'LastName': 'Kwok', 'Affiliation': 'Department of Prosthetics and Orthotics, Prince of Wales Hospital, Hong Kong, PRC.'}, {'ForeName': 'Man Sang', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, PRC.'}]",Spine,['10.1097/BRS.0000000000003559']
2130,32453224,Employment Status for the First Decade Following Randomization to Cervical Disc Arthroplasty versus Fusion.,"STUDY DESIGN


An analysis of employment status data up to 10 years following the FDA IDE randomized trial and extension as post-approval study comparing BRYAN cervical disc arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF) was performed.
OBJECTIVE


Ten-year experience with the BRYAN disc arthroplasty trial provides opportunity to report patient employment data.
SUMMARY OF BACKGROUND DATA


The long-term consequences of arthroplasty remain incomplete, including the occurrence of occupational compromise.
METHODS


Patients employment status were measured at regular intervals in both groups up to10 years.
RESULTS


The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups. In the investigational group, 49.2% returned to work at 6 weeks compared to 39.4% of the control group (p = 0.046). At 6 months and 2 years postoperatively, there was a similar likelihood of active employment in both groups. After 2 years at all time points, 10% drop-off seen in control group employment, but not in investigational group. At 10 years, 76.2% CDA patients were employed to 64.1% ACDF patients (p = 0.057). Preoperative variables influencing work status at 10 years following CDA included: preoperative work status, age and SF-36 MCS; whereas, no significant preoperative factor identified with ACDF. Time to return to work was influenced in both groups by preoperative work status; and in the ACDF group: reaching age 65 at 10-year visit, preoperative arm pain and NDI score had significant influences.
CONCLUSION


More patients returned to work at 6 weeks after CDA compared to ACDF, although there was no difference by 6 months. After 2 years, a nonsignificant trend toward higher employment rates in the arthroplasty group was evident, but this difference could not be validated due to the very high rate of loss of patients to the follow-up.
LEVEL OF EVIDENCE


2.",2020,The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups.,['Patients employment status were measured at regular intervals in both groups up to10 years'],"['Cervical Disc Arthroplasty versus Fusion', 'cervical disc arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF']","['preoperative employment status proportion', 'employment rates', 'active employment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0380675,The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups.,"[{'ForeName': 'Siddharth A', 'Initials': 'SA', 'LastName': 'Badve', 'Affiliation': 'Hartsville Orthopedics & Sports Medicine, Carolina Pines Regional Medical Center, Hartsville, SC.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Florman', 'Affiliation': 'Neurological Surgery, Maine Medical Center, Scarborough, ME.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': 'Department of Neurological Surgery, University of Miami, Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Kurra', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Professor of Orthopedic Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Lavelle', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St., Syracuse, NY 13210.'}]",Spine,['10.1097/BRS.0000000000003565']
2131,32453274,Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.,"BACKGROUND


Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences.
OBJECTIVE


The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD.
METHODS


A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice.
RESULTS


A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively).
CONCLUSION


It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.",2020,Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002).,"['patients faced with the decision to replace their ICD', 'Patients approaching ICD battery depletion', '30 patients']","['Implantable Cardioverter-Defibrillator Replacement', 'decision support intervention', 'decision support intervention or usual care', 'usual care']","['recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice', 'better knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",30.0,0.0883156,Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002).,"[{'ForeName': 'Krystina B', 'Initials': 'KB', 'LastName': 'Lewis', 'Affiliation': 'Krystina B. Lewis, RN, MN, PhD Assistant Professor, School of Nursing, University of Ottawa, and Registered Nurse, Affiliate Researcher, University of Ottawa Heart Institute, Ontario, Canada. David Birnie, MD Deputy Division Head of Cardiology and Staff Cardiac Electrophysiologist, University of Ottawa Heart Institute, Ontario, Canada. Sandra L. Carroll, RN, PhD Associate Professor and Vice-Dean, Health Sciences and Executive Director, School of Nursing, McMaster University, Hamilton, Canada. Carolynne Brousseau-Whaley, RN, MN Electrophysiology Regional Cardiac Care Coordinator, University of Ottawa Health Institute, Ontario, Canada. Lorraine Clark, RN, MHS Clinical Manager, Clinical Services, University of Ottawa Heart Institute, Ontario, Canada. Martin Green, MD Staff Cardiac Electrophysiologist, University of Ottawa Heart Institute, Ontario, Canada. Girish M. Nair, MBBS, MSc Staff Cardiac Electrophysiologist, University of Ottawa Heart Institute, Ontario, Canada. Pablo B. Nery, MD Staff Cardiac Electrophysiologist, University of Ottawa Heart Institute, Ontario, Canada. Calum Redpath, MD Staff Cardiac Electrophysiologist, University of Ottawa Heart Institute, Ontario, Canada. Dawn Stacey, RN, PhD Professor, School of Nursing, University of Ottawa, and Senior Scientist, Ottawa Hospital Research Institute, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': ''}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Carolynne', 'Initials': 'C', 'LastName': 'Brousseau-Whaley', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Girish M', 'Initials': 'GM', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Nery', 'Affiliation': ''}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Redpath', 'Affiliation': ''}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000694']
2132,32453275,TAS2R38 Haplotype Predicts 24-Hour Urinary Sodium Excretion in Patients With Heart Failure and Their Family Caregivers.,"BACKGROUND


Adherence to a low-sodium diet is essential to self-care of heart failure (HF). Genetic determinants of preference for high-sodium foods may impede adherence but have not been well-studied.
OBJECTIVE


Our purpose was to examine if TAS2R38 haplotype predicted salt taste sensitivity and dietary sodium intake among patients with HF.
METHOD


This pilot study used baseline data from a large interventional randomized control trial to support adherence to a low-sodium diet in patients with HF and their family caregivers. Participants were tested for salt taste sensitivity and provided a 24-hour urinary sodium sample and a blood sample for DNA analysis at baseline. Fungiform papillae were counted. χ Test and 1-way analysis of variance were used to compare haplotype groups. Linear regression was performed to examine predictors of salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density.
RESULTS


There were 42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker). Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
CONCLUSIONS


The results of our study partially supported our hypothesis that PAV homozygous haplotype predicts 24-hour urinary sodium excretion. With our small sample size, more research is needed. Understanding genetic influences on taste can lead to development of educational interventions tailored to patients with HF and their family caregivers to better support dietary adherence.",2020,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
","['patients with HF', '42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker', 'Patients With Heart Failure and Their Family Caregivers', 'patients with HF and their family caregivers']",['low-sodium diet'],"['salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density', 'urinary sodium excretion', '24-hour urinary sodium excretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0012169', 'cui_str': 'Low sodium diet'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0226968', 'cui_str': 'Structure of fungiform papillae of tongue'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",42.0,0.028638,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Jennifer L Smith, PhD, RN Postdoctoral Fellow, College of Nursing, University of Kentucky, Lexington. Gia Mudd-Martin, PhD, MPH, RN, FAHA Associate Professor, College of Nursing, University of Kentucky, Lexington. Steven Estus, PhD Professor, Department of Physiology and Sanders-Brown Center on Aging, University of Kentucky, Lexington. Terry A. Lennie, PhD, RN, FAHA, FAAN Professor, Senior Associate Dean, College of Nursing, University of Kentucky, Lexington. Misook L. Chung, PhD, RN, FAHA, FAAN Professor, College of Nursing, University of Kentucky, Lexington.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Mudd-Martin', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Estus', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Lennie', 'Affiliation': ''}, {'ForeName': 'Misook L', 'Initials': 'ML', 'LastName': 'Chung', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000692']
2133,32453288,A Randomized Internet-Based Pilot Feasibility and Planning Study of Cherry Extract and Diet Modification in Gout.,"OBJECTIVE


The aim of this study was to conduct a 9-month pilot Internet randomized controlled trial (RCT) of cherry extract and diet modification in gout to assess the feasibility of an Internet study and obtain effect estimates.
METHODS


After providing online informed consent in response to Internet advertisements and social media or clinic flyers, 84 people with physician-confirmed gout were randomized to either cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via Internet and phone calls. The primary objective was the feasibility of an Internet study, and secondary objectives were to obtain effect estimates for gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future trials.
RESULTS


Of the 84 people randomized, overall completion rates were more than 80% for most study procedures up to 6 months and similar for the 2 active comparators. Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively. Any AEs and gastrointestinal symptoms/AEs at 9 months in cherry extract and diet modification groups were 3% versus 0% and 28% versus 27%, respectively.
CONCLUSIONS


An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed.",2020,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","['Gout', '84 people randomized', '84 people with physician-confirmed gout']","['RCT', 'cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification', 'cherry extract and diet modification', 'Cherry Extract and Diet Modification', 'placebo']","['gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs', 'overall completion rates', 'gout flares and HAQ scores']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}]",84.0,0.143097,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': 'From the Medicine Service, VA Medical Center, Birmingham, AL.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine at School of Medicine.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Darnell', 'Affiliation': 'Department of Nutrition.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Viocare, Princeton, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, School of Public Health.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001004']
2134,32453304,Effects of Different Plyometric Training Frequencies on Measures of Athletic Performance in Prepuberal Male Soccer Players.,"Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana, Y. Effects of different plyometric training frequencies on measures of athletic performance in prepuberal male soccer players. J Strength Cond Res 34(6): 1609-1617, 2020-This study aimed to compare the effects of 1 vs. 2 sessions of equal-weekly volume plyometric training (PT) across 8 weeks on measures of athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength) in prepuberal male soccer players. Thirty participants were randomly assigned either to 1 session PT group (1SPT [n = 15]) or 2 sessions PT group (2SPT [n = 15]). Plyometric training was integrated into their regular soccer training routine. Pretraining and posttraining tests for the assessment of sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance were conducted. Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94 [large], p = 0.02), SLJ (F(1,56) = 16.63, ES = 1.09 [large], p < 0.001), CMJ (F(1,56) = 15.43, ES = 1.04 [large], p < 0.001), SJ (F(1,56) = 20.27, ES = 1.20 [large], p < 0.001), RSI (F(1,56) = 26.26, ES = 1.36 [large], p < 0.001), and kicking distance (F(1,56) = 47.19, ES = 1.83 [large], p < 0.001). There were no training group × time interactions in all the measured outcomes. In conclusion, when an equated moderate volume of jumps is performed, higher PT frequency across 8 weeks has no extra effects on prepuberal male soccer players' measures of athletic performance. The present findings may help optimizing PT interventions dedicated to prepuberal male soccer players.",2020,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","['Prepuberal Male Soccer Players', 'J Strength Cond Res 34(6', 'prepuberal male soccer players', 'Thirty participants']","['Plyometric Training Frequencies', 'equal-weekly volume plyometric training (PT', 'Plyometric training']","['athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength', 'sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance', 'Athletic Performance', 'time interactions', 'time for 5-m sprint-time performance', 'athletic performance', 'Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",30.0,0.0338811,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, University of Los Lagos, Osorno, Chile.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Jlalia', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis El Manar, Orthopedic Pediatric Department, Kassab Institute of Orthopedic Surgery, Ksar Said, Tunisia.'}, {'ForeName': 'Bessem', 'Initials': 'B', 'LastName': 'Mkaouer', 'Affiliation': 'Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Younés', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002486']
2135,32453306,Chronopharmacokinetics and Food-Effects of Single-Dose LCP-tacrolimus in Healthy Volunteers.,"BACKGROUND


A modified-release version of tacrolimus, LCP-tacrolimus (LCPT; Envarsus XR, Veloxis Pharmaceuticals), has been licensed in the United States for prophylaxis of organ rejection in de novo kidney transplant patients. As tacrolimus has a narrow therapeutic window, the impact of circadian patterns on LCPT drug exposure, including food and chronopharmacokinetic effects, needs to be elucidated to optimize dosing.
METHODS


Two randomized, crossover, Phase 1 studies were conducted in healthy volunteers. The first assessed the effect of morning versus evening dosing on the pharmacokinetic profile of LCPT 2 mg; the second assessed the effect of food on the pharmacokinetic profile of LCPT 5 mg. In both, blood samples were drawn from participants for up to 144 h after administration of a single LCPT dose.
RESULTS


No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26). After a high-calorie meal in the morning, the AUC0-24 reduced by 54% (ratio of geometric means = 45.6%; p<0.0001) and peak blood concentration reduced by 22% (ratio of geometric means = 78.4%; p=0.0006). However, the terminal half-life did not differ between fasted and fed states (33.3 vs. 34.8 h; p=0.16), implying that these differences occurred due to altered bioavailability rather than modified clearance.
CONCLUSIONS


For LCPT, no chronopharmacokinetic effects were observed, whereas food significantly reduced the 24-h exposure and the peak blood concentration.",2020,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","['Healthy Volunteers', 'novo kidney transplant patients', 'healthy volunteers']","['Single-Dose LCP-tacrolimus', 'tacrolimus', 'tacrolimus, LCP-tacrolimus (LCPT']","['total clearance', '24-h exposure and the peak blood concentration', 'time to reach maximum blood concentration', 'area under the time-concentration curve (AUC', 'peak blood concentration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.169971,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","[{'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Alloway', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Trofe-Clark', 'Affiliation': 'Department of Pharmacy, Hospital of the University of Pennsylvania and Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Brennan', 'Affiliation': 'Comprehensive Transplant Center, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'UC San Diego Health, San Diego, CA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Cohen', 'Affiliation': 'Department of Transplantation, Yale New Haven Hospital, New Haven, CT.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Meier-Kriesche', 'Affiliation': 'Veloxis Pharmaceuticals, Cary, NC.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Veloxis Pharmaceuticals, Cary, NC.'}, {'ForeName': 'Misbah A', 'Initials': 'MA', 'LastName': 'Moten', 'Affiliation': 'Veloxis Pharmaceuticals, Cary, NC.'}, {'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego, La Jolla, CA.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000773']
2136,32453346,"Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use: A Randomized Clinical Trial.","Importance


Many employers use workplace wellness programs to improve employee health and reduce medical costs, but randomized evaluations of their efficacy are rare.
Objective


To evaluate the effect of a comprehensive workplace wellness program on employee health, health beliefs, and medical use after 12 and 24 months.
Design, Setting, and Participants


This randomized clinical trial of 4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018. Members of the treatment group (n = 3300) received incentives to participate in the workplace wellness program. Members of the control group (n = 1534) did not participate in the wellness program. Statistical analysis was performed on April 9, 2020.
Interventions


The 2-year workplace wellness program included financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management).
Main Outcomes and Measures


Measures taken at 12 and 24 months included clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes).
Results


Among the 4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years), no significant effects of the program on biometrics, medical diagnoses, or medical use were seen after 12 or 24 months. A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002). The intervention significantly improved a set of employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly decreased by 0.07 SDs (95% CI, -0.12 to -0.01 SDs; P = .02); however, effects on individual belief measures were not significant.
Conclusions and Relevance


This randomized clinical trial showed that a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.
Trial Registration


American Economic Association Randomized Controlled Trial Registry number: AEARCTR-0001368.",2020,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"['4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years', '4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018']","['incentives to participate in the workplace wellness program', 'Workplace Wellness Program', 'comprehensive workplace wellness program']","['physical health outcomes, rates of medical diagnoses, or the use of health care services', 'employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly', 'proportion of employees', 'biometrics, medical diagnoses, or medical use', 'employee health, health beliefs, and medical use', 'Employee Health, Health Beliefs, and Medical Use', 'clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes', 'financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0079272', 'cui_str': 'Employee Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",4834.0,0.0185591,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Reif', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Payne', 'Affiliation': 'Department of Recreation, Sport and Tourism, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Molitor', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1321']
2137,32453368,Effect of Antihypertensive Medication Reduction vs Usual Care on Short-term Blood Pressure Control in Patients With Hypertension Aged 80 Years and Older: The OPTIMISE Randomized Clinical Trial.,"Importance


Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.
Objective


This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.
Design, Setting, and Participants


The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.
Interventions


Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.
Main Outcomes and Measures


The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.
Results


Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
Conclusions and Relevance


Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.
Trial Registration


EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221.",2020,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","['older patients with hypertension', 'Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included', 'older patients with polypharmacy and multimorbidity', 'Patients With Hypertension Aged 80 Years and Older', '569 patients randomized (mean age, 84.8 years; 276 [48.5%] women', '69 primary care sites in England', 'older patients treated with multiple antihypertensive medications', 'Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019']","['antihypertensive medication reduction (removal of 1 drug [intervention], n\u2009=\u2009282) or usual care (control, n\u2009=\u2009287), in which no medication changes were mandated', 'Antihypertensive Medication Reduction vs Usual Care', 'antihypertensive medications']","['Medication reduction', 'serious adverse event', 'systolic blood pressure control or adverse events', 'systolic blood pressure', 'proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events', 'Mild Systolic Hypertension']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension'}]",569.0,0.108474,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Sheppard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Burt', 'Affiliation': 'The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Temple', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rosalyn', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Shahela', 'Initials': 'S', 'LastName': 'Kodabuckus', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Population Sciences and Medical Education Unit, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rupert A', 'Initials': 'RA', 'LastName': 'Payne', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Marney', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Patient and public involvement representative, London, United Kingdom.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.4871']
2138,32453369,Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial.,"Importance


Abdominal aortic aneurysms affect more than 3% of US older adults.
Objective


To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
Design, Setting, and Participants


Parallel, 2-group, randomized clinical trial that was conducted at 22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms. The final date of follow-up was July 31, 2018.
Interventions


Patients were randomized to receive twice daily for 2 years doxycycline 100 mg orally (as capsules) (n = 133) or placebo (n = 128).
Main Outcomes and Measures


The primary outcome was change in abdominal aortic aneurysm maximum transverse diameter measured from CT images at baseline and follow-up at 2 years. Patients were assigned ranks based on the maximum transverse diameter (measured or imputed) of the aorta and also if they underwent aneurysm repair or died. The ranks were converted to scores having a normal distribution to facilitate the primary analysis (""normal scores"").
Results


Of 261 patients randomized, no follow-up CT scans were obtained on 7 (3%), leaving a final analysis set of 129 patients assigned to doxycycline and 125 to placebo (mean [SD] age, 71.0 years [7.4 years], 35 women [14%]). The outcome normal scores used in the primary analysis were based on maximum transverse diameter (measured or imputed) in 113 patients (88%) in the doxycycline group and 112 patients (90%) in the placebo group; aneurysm repair in 13 (10%) and 9 (7%), and death in 3 (2%) and 4 (3%), respectively. The primary outcome, normal scores reflecting change in aortic diameter, did not differ significantly between the 2 groups, mean change in normal scores, 0.0262 vs -0.0258 (1-sided P = .71). Mean (SD) baseline maximum transverse diameter was 4.3 cm (0.4 cm) for doxycycline and 4.3 cm (0.4 cm) for placebo. At the 2-year follow-up, the change in measured maximum transverse diameter was 0.36 cm (95% CI, 0.31 to 0.40 cm) for 96 patients in the doxycycline group vs 0.36 cm (95% CI, 0.30 to 0.41 cm) for 101 patients in the placebo group (difference, 0.0; 95% CI, -0.07 to 0.07 cm; 2-sided P = .93). No patients were withdrawn from the study because of adverse effects. Joint pain occurred in 84 of 129 patients (65%) with doxycycline and 79 of 125 (63%) with placebo.
Conclusions and Relevance


Among patients with small infrarenal abdominal aortic aneurysms, doxycycline compared with placebo did not significantly reduce aneurysm growth at 2 years. These findings do not support the use of doxycycline for reducing the growth of small abdominal aortic aneurysms.
Trial Registration


ClinicalTrials.gov Identifier: NCT01756833.",2020,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","['22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms', 'Patients With Small Infrarenal Abdominal Aortic Aneurysms', 'patients with small infrarenal abdominal aortic aneurysms', '261 patients randomized']","['Doxycycline', 'doxycycline 100 mg orally (as capsules', 'doxycycline', 'placebo']","['Joint pain', 'maximum transverse diameter', 'growth of abdominal aortic aneurysm', 'death', 'mean change in normal scores', 'normal scores reflecting change in aortic diameter', 'change in abdominal aortic aneurysm maximum transverse diameter measured from CT images', 'Mean (SD) baseline maximum transverse diameter', 'aneurysm repair', 'aneurysm growth']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",261.0,0.567673,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","[{'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Matsumura', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Department of Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, Washington.'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blackwelder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': 'Genentech, Oakland, California.'}, {'ForeName': 'Marniker', 'Initials': 'M', 'LastName': 'Wijesinha', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.5230']
2139,32453377,"Safety, Tolerability, and Efficacy of Viltolarsen in Boys With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A Phase 2 Randomized Clinical Trial.","Importance


An unmet need remains for safe and efficacious treatments for Duchenne muscular dystrophy (DMD). To date, there are limited agents available that address the underlying cause of the disease.
Objective


To evaluate the safety, tolerability, and efficacy of viltolarsen, a novel antisense oligonucleotide, in participants with DMD amenable to exon 53 skipping.
Design, Setting, and Participants


This phase 2 study was a 4-week randomized clinical trial for safety followed by a 20-week open-label treatment period of patients aged 4 to 9 years with DMD amenable to exon 53 skipping. To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened. Study enrollment occurred between December 16, 2016, and August 17, 2017, at sites in the US and Canada. Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019.
Interventions


Participants received 40 mg/kg (low dose) or 80 mg/kg (high dose) of viltolarsen administered by weekly intravenous infusion.
Main Outcomes and Measures


Primary outcomes of the trial included safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles. Secondary outcomes included additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function.
Results


Of the 16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years. After 20 to 24 weeks of treatment, significant drug-induced dystrophin production was seen in both viltolarsen dose cohorts (40 mg/kg per week: mean [range] 5.7% [3.2-10.3] of normal; 80 mg/kg per week: mean [range] 5.9% [1.1-14.4] of normal). Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug. No serious adverse events or deaths occurred during the study. Compared with 65 age-matched and treatment-matched natural history controls, all 16 participants treated with viltolarsen showed significant improvements in timed function tests from baseline, including time to stand from supine (viltolarsen: -0.19 s; control: 0.66 s), time to run/walk 10 m (viltolarsen: 0.23 m/s; control: -0.04 m/s), and 6-minute walk test (viltolarsen: 28.9 m; control: -65.3 m) at the week 25 visit.
Conclusions and Relevance


Systemic treatment of participants with DMD with viltolarsen induced de novo dystrophin production, and clinical improvement of timed function tests was observed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02740972.",2020,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","['To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened', 'Boys', '16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years', 'participants with DMD with', 'participants with DMD amenable to exon 53 skipping', 'patients aged 4 to 9 years with DMD amenable to exon 53 skipping', 'Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019', 'Exon 53 Skipping']","['viltolarsen', 'viltolarsen administered by weekly intravenous infusion']","['serious adverse events or deaths', 'additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function', 'Safety, Tolerability, and Efficacy of Viltolarsen', ""safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles"", 'safety, tolerability, and efficacy', 'timed function tests', 'dystrophin production']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",17.0,0.134131,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","[{'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Clemens', 'Affiliation': 'Department of Neurology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vamshi K', 'Initials': 'VK', 'LastName': 'Rao', 'Affiliation': ""Division of Neurology, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Connolly', 'Affiliation': ""Division of Neurology, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus.""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Harper', 'Affiliation': ""Children's Hospital of Richmond at Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Division of Pediatric Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Department of Pediatrics, UC Davis Health, University of California, Davis, Sacramento.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Zaidman', 'Affiliation': 'Department of Neurology, Washington University at St Louis, St Louis, Missouri.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Morgenroth', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Osaki', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Youhei', 'Initials': 'Y', 'LastName': 'Satou', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Hoffman', 'Affiliation': 'AGADA BioSciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.1264']
2140,32453383,Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial.,"Importance


Strategies to reduce the inappropriate prescription of antipsychotics have been the focus of recent attention but have shown considerable variation in their effectiveness.
Objective


To evaluate the effectiveness of academic detailing in nursing homes targeting appropriate prescribing of antipsychotics.
Design, Setting, and Participants


We conducted a pragmatic, cluster randomized clinical trial comparing the effect of academic detailing vs usual care on prescribing antipsychotics in 40 nursing homes with 5363 residents in Ontario, Canada. Data were collected from October 2015 to March 2016 and analyzed from April to August 2018. Primary analyses were conducted using intention to treat.
Intervention


Academic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits). Academic detailers had direct and ongoing contact with the nursing homes from the time of launch.
Main Outcomes and Measures


The primary outcome, defined at the level of the resident, was whether continuous antipsychotics were dispensed in the past week. Secondary outcomes included prescribing of other psychotropic medications and clinical outcomes and scores. Prescribing outcomes were assessed at baseline and at 3, 6, and 12 months, and clinical outcomes and scores were assessed at baseline and 3 and 6 months.
Results


A total of 40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents). Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men). At 12 months, there was no statistically significant difference in the frequency of daily antipsychotic use (intervention: 569 patients [25.2%]; control: 769 [25.6%]; odds ratio, 1.06; 95% CI, 0.93-1.20; P = .49). There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
Conclusions and Relevance


The intervention did not further reduce antipsychotic prescribing in nursing homes beyond system-level secular trends occurring alongside usual care. Our findings highlight the need for a more targeted approach to quality improvement strategies, including academic detailing, that account for the timing and topic of interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02604056.",2020,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","['Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men', '40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents', 'Data were collected from October 2015 to March 2016 and analyzed from April to August 2018', 'Nursing Homes', '40 nursing homes with 5363 residents in Ontario, Canada']","['academic detailing vs usual care on prescribing antipsychotics', 'Antipsychotic Medication', 'Academic Detailing', 'Intervention\n\n\nAcademic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits']","['depression (mean [SD] Depression Rating Scale score', 'prescribing of other psychotropic medications and clinical outcomes and scores', 'frequency of daily antipsychotic use', 'pain', 'rates of health care utilization']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",5363.0,0.142155,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Tadrous', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Kinwah', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Women's College Research Institute, Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gomes', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'University of Ottawa School of Epidemiology, Public Health and Preventive Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5724']
2141,32453393,"Supplementation with vitamin D or ω-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects of vitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents.
OBJECTIVES


We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis.
METHODS


Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo.
RESULTS


A total of 147 women were screened and 69 were randomly assigned as follows: 27 to vitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P = 0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P = 0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P = 0.39]. Neither of the intervention arms were statistically different from placebo.
CONCLUSIONS


In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.",2020,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","['young women with endometriosis', 'adolescent girls and young women with endometriosis (SAGE', 'A total of 147 women were screened and 69 were randomly assigned as follows: 27 to', 'Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled', 'young women with endometriosis, supplementation with', 'Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain', 'endometriosis-associated pain in adolescents']","['vitamin D or ω-3 fatty acids', 'vitamin D3; 20 to fish oil', '2000 IU vitamin D3, 1000 mg fish oil, or placebo', 'placebo', 'vitamin D', 'vitamin D and omega-3 (n-3) fatty acid supplementation']","['quality of life', 'quality of life, pain catastrophizing, and pain medication usage', 'pain measured by the visual analog scale (VAS', 'pelvic pain', 'VAS pain reduction', 'pain', 'VAS pain', 'pain score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",147.0,0.819757,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Nodler', 'Affiliation': 'Department of Obstetrics and Gynecology, Colorado Center for Reproductive Medicine-Houston, Houston, TX, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': 'Vitonis', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Karevicius', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Malsch', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vishnudas', 'Initials': 'V', 'LastName': 'Sarda', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ayotunde', 'Initials': 'A', 'LastName': 'Fadayomi', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Harris', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Missmer', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa096']
2142,32453396,"Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial.","BACKGROUND


It is unknown which compounds in spermatozoa or seminal plasma may be involved in the regulation of sperm motility.
OBJECTIVES


The aim of this study was to investigate the effects of DHA (22:6n-3), vitamin E, and their probable interactions in men with asthenozoospermia.
METHODS


A factorial, randomized, double-blind, placebo-controlled trial was conducted in infertility clinics in Tehran, Iran. The participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function. Their concentration of spermatozoa and percentage of morphologically normal spermatozoa were equal to or above the lower reference limits, according to the fifth edition of the WHO guideline. Out of 717 men referred to the infertility clinics, 180 asthenozoospermic men were randomly assigned to 1 of 4 groups according to stratified blocked randomization by age and sperm concentration. Participants took daily 465 mg DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP) for 12 wk. Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity were measured at baseline and after 12 wk.
RESULTS


After the intervention, mean ± SD sperm progressive motility was greater in the DE group (27.9 ± 2.8) than in the DP (25.7 ± 3.4), EP (26.1 ± 2.8), and PP (25.8 ± 2.6) groups (P < 0.05). Sperm count (P = 0.001) and concentration (P = 0.044) increased significantly in the DE group compared with the other 3 groups, whereas other semen parameters were not significantly different between the groups after the intervention. Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
CONCLUSIONS


Combined DHA and vitamin E supplements led to increased sperm motility; however, no significant changes occurred in sperm morphology and vitality in asthenozoospermic men.This trial was registered at clinicaltrials.gov as NCT01846325.",2020,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","['participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function', '717 men referred to the infertility clinics, 180 asthenozoospermic men', 'infertility clinics in Tehran, Iran', 'men with asthenozoospermia', 'asthenozoospermic men']","['DHA and vitamin E', 'DHA (22:6n-3), vitamin E', 'DHA and vitamin E supplements', 'DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP', 'placebo']","['Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity', 'sperm motility', 'Sperm count', 'Serum concentrations of n-3 PUFAs', 'spermatogram, seminal oxidative stress, and sperm phospholipids', 'mean\xa0±\xa0SD sperm progressive motility', 'sperm morphology and vitality']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology'}]",717.0,0.607753,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Eslamian', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Amirjannati', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Noori', 'Affiliation': ""Division of Nephrology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa124']
2143,32453406,Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial.,"Importance


Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.
Objective


To compare 3 treatment strategies for MOH.
Design, Setting, and Participants


This open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.
Interventions


Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal.
Main Outcomes and Measures


The primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH.
Results


Of 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).
Conclusion and Relevance


All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.
Trial Registration


ClinicalTrials.gov Identifier: NCT02993289.",2020,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","['120 patients, 102 (mean [SD] age', '43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up', 'Medication Overuse Headache', 'tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019', '483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding', '75 refused participation and 120 were included']","['withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal']","['chance of MOH cure', 'reduction of migraine days per month, use of short-term medication, or headache intensity', 'Headache days per month', 'change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH', 'episodic headache', 'change in headache days', 'cured of MOH']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0039567', 'cui_str': 'Tertiary Sector'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",483.0,0.1209,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","[{'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Currently a PhD student at the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Maria Lurenda', 'Initials': 'ML', 'LastName': 'Westergaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1179']
2144,32453449,Collaborative Care for Primary Care Treatment of Late-Life Depression in Singapore: Randomized Controlled Trial.,"BACKGROUND


The effectiveness and portability of the collaborative care model in the primary care treatment of depression has not been demonstrated in many randomized controlled trials in healthcare settings across the world. We determined the effectiveness of collaborative care management of elderly depression in the primary care setting in Singapore.
METHOD


Eligible participants with depressive symptoms were randomized to six-month duration usual care (UC, N = 112) or collaborative care (CC, N = 102). Outcome measures were HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3-month, 6-month and 12-month, care satisfaction at 6-month, and also measured on 120 participants who refused referral (non-receipt of care, NC). Primary outcome was HDRS-17 measure of depression severity, response and remission at 6-month.
RESULTS


HDRS scores in CC group compared to UC group were reduced more at 6-month (1.5 points difference in change from baseline), and also at 3-month and 12-month, with similar observations of differences for GDS and BDI. There was significantly greater improvement for both CC and UC groups compared to NC group. The CC group was about 1.5 times more likely to show HDRS treatment response and remission, and more than 2 times likely to show GDS treatment response and remission than the UC and NC groups, as well as better quality of life improvement (P < 0.001) and better care satisfaction (P < 0.001).
CONCLUSION


Collaborative care is effective for primary care treatment of older persons with depression and is portable in diverse health care settings. This article is protected by copyright. All rights reserved.",2020,"RESULTS


HDRS scores in CC group compared to UC group were reduced more at 6-month","['older persons with depression', 'Primary Care Treatment of Late-Life Depression in Singapore', 'Eligible participants with depressive symptoms', 'elderly depression in the primary care setting in Singapore']","['collaborative care management', 'six-month duration usual care (UC, N\xa0=\xa0112) or collaborative care']","['care satisfaction', 'GDS treatment response and remission', 'HDRS scores', 'HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3-month, 6-month and 12-month, care satisfaction', 'quality of life improvement', 'HDRS-17 measure of depression severity, response and remission at 6-month', 'HDRS treatment response and remission']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0983118,"RESULTS


HDRS scores in CC group compared to UC group were reduced more at 6-month","[{'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Ma Shwe Zin', 'Initials': 'MSZ', 'LastName': 'Nyunt', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Formerly, Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Formerly, Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore.'}, {'ForeName': 'Calvin Sl', 'Initials': 'CS', 'LastName': 'Fones', 'Affiliation': 'Formerly, Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore.'}, {'ForeName': 'Soo Meng', 'Initials': 'SM', 'LastName': 'Ko', 'Affiliation': 'Formerly, Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore.'}]",International journal of geriatric psychiatry,['10.1002/gps.5353']
2145,32453453,Ultra-early Blood Pressure Reduction Attenuates Hematoma Growth and Improves Outcome in Intracerebral Hemorrhage.,"OBJECTIVE


To investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in ICH patients who received intravenous nicardipine treatment within 2 hrs after onset of symptoms.
METHODS


A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label randomized clinical trial in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine within 4.5 hours of symptom onset. We have included 913 patients with complete imaging and follow-up data in the present analysis.
RESULTS


Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group as compared with standard treatment group (P = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% CI, 0.34-0.92; P = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; P = 0.004) and good outcome (OR, 1.68; 95% CI, 1.01-2.83; P = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
INTERPRETATION


In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine within 2 hours of symptom onset, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. This article is protected by copyright. All rights reserved.",2020,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","['Intracerebral Hemorrhage', '913 patients with complete imaging and follow-up data in the present analysis', 'ICH patients who received intravenous', 'patients with primary ICH']","['intensive blood pressure treatment', 'intensive versus standard blood pressure treatment with nicardipine', 'Ultra-early Blood Pressure Reduction', 'nicardipine']","['hematoma growth and improved functional outcome', 'modified Rankin Scale score distribution', 'rate of functional independence', 'Ultra-early intensive blood pressure reduction', 'elevated blood pressure', 'risk of hematoma growth', 'frequency of ICH expansion', 'intensive blood pressure reduction']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}]",913.0,0.129574,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Warren', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Neurology and Neurorehabilitation, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine (Neurology), Ottawa Hospital Research Institute, University of Ottawa, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",Annals of neurology,['10.1002/ana.25793']
2146,32453510,Effects of positive-negative antismoking messages to quit smoking among male college students: A randomized field study.,"AIM


Based on the main concept of reasoned action theory, this study aimed to examine which of the attitude and subjective norms affect the intention of smoking cessation by using four types of antismoking messages: (1) positively and( 2) negatively stimulating one's attitude toward smoking cessation; and (3) positively and (4) negatively reflected subjective norms for second-hand smoking.
METHODS


We conducted a randomized field study in smoking areas in universities located in D city of South Korea. Two hundred and eighty-seven male students who smoke daily were recruited in the field and randomly divided into four experimental groups and one control group. The participants in each experimental group were asked to read attitude/positive, attitude/negative, norm/positive, and norm/negative message. The data of attitude, subjective norm, and intention to stop smoking were collected.
RESULTS


There were significant differences in the intention to quit smoking in attitude/negative messages (F = 4.311, p = .015) and norm/positive messages (F = 4.353, p = .014). The effects of subjective norm were greater than those of attitude (p < .001).
CONCLUSION


Emphasizing the positive subjective norm for smoking cessation among young smokers might be effective in persuading them to quit smoking.",2020,"There were significant differences in the intention to quit smoking in attitude/negative messages (F = 4.311, p = .015) and norm/positive messages (F = 4.353, p = .014).","['male college students', 'young smokers', 'smoking areas in universities located in D city of South Korea', 'Two hundred and eighty-seven male students who smoke daily']",['positive-negative antismoking messages'],"['intention to quit smoking in attitude/negative messages', 'attitude, subjective norm, and intention to stop smoking']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}]",287.0,0.0224146,"There were significant differences in the intention to quit smoking in attitude/negative messages (F = 4.311, p = .015) and norm/positive messages (F = 4.353, p = .014).","[{'ForeName': 'Shinae', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hyojung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12349']
2147,32449896,Peritoneal Flap in Robot-Assisted Radical Prostatectomy.,"BACKGROUND


Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
METHODS


A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
RESULTS


The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
CONCLUSION


A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.",2020,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","['232 patients with prostate cancer who underwent RARP with PLND', '108 patients (46.6']","['Peritoneal Flap in Robot-Assisted Radical Prostatectomy', 'peritoneal flap', 'robot-assisted radical prostatectomy (RARP']","['degree of stress urinary incontinence', 'rate of postoperative lymphocele', 'lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence', 'rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2', 'lymphocele volume', 'symptomatic lymphocele', 'no complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",232.0,0.0672329,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': ''}, {'ForeName': 'Gjoko', 'Initials': 'G', 'LastName': 'Stojanoski', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rosenhammer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stolzlechner', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ponholzer', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dreissig', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0243']
2148,32449919,Orthostatic blood pressure recovery is associated with the rate of cognitive decline and mortality in clinical Alzheimer's disease.,"BACKGROUND


Impaired recovery of blood pressure (BP) after standing has been shown to be related to cognitive function and mortality in people without dementia, but its role in people with Alzheimer's disease (AD) is unknown. The aim of this study was to investigate the association of the orthostatic BP response with cognitive decline and mortality in AD.
METHODS


In this post-hoc analysis of a randomized controlled trial (Nilvad), we measured the beat-to-beat response of BP upon active standing in mild-to-moderate AD. This included the initial drop (nadir within 40 seconds) and recovery after 1-minute, both expressed relative to resting values. We examined the relationship between a small or large initial drop (median split) and unimpaired (≥100%) or impaired recovery (<100%) with 1.5-year change in Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality.
RESULTS


We included 55 participants (age 73.1±6.2 years). Impaired BP recovery was associated with higher increases in ADAS-cog scores (systolic: β [95% CI]=5.6 [0.4-10.8], p=0.035; diastolic: 7.6 [2.3-13.0], p=0.006). During a median follow-up time of 49 months, 20 participants died. Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95% CI]=5.5 [1.9 -16.1], p=0.002). The initial BP drop was not associated with any outcome. Results were adjusted for age, sex and intervention group.
CONCLUSIONS


Failure to fully recover BP after 1-minute of standing is associated with cognitive decline and mortality in AD. As such, BP recovery can be regarded as an easily obtained marker of progression rate of AD.",2020,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[""people with Alzheimer's disease (AD"", '55 participants (age 73.1±6.2 years']",[],"['mortality (systolic: HR', 'orthostatic BP response', 'Impaired BP recovery', 'ADAS-cog scores (systolic: β', 'blood pressure (BP', 'Orthostatic blood pressure recovery', ""Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.363489,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[{'ForeName': 'Rianne A A', 'Initials': 'RAA', 'LastName': 'de Heus', 'Affiliation': 'Radboud university medical center, Donders Institute for Brain Cognition and Behaviour, Department of Geriatric Medicine, Radboudumc Alzheimer Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Daan L K', 'Initials': 'DLK', 'LastName': 'de Jong', 'Affiliation': 'Radboud university medical center, Donders Institute for Brain Cognition and Behaviour, Department of Geriatric Medicine, Radboudumc Alzheimer Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rijpma', 'Affiliation': 'Radboud university medical center, Donders Institute for Brain Cognition and Behaviour, Department of Geriatric Medicine, Radboudumc Alzheimer Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Lawlor', 'Affiliation': ""Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Radboud university medical center, Donders Institute for Brain Cognition and Behaviour, Department of Geriatric Medicine, Radboudumc Alzheimer Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Radboud university medical center, Donders Institute for Brain Cognition and Behaviour, Department of Geriatric Medicine, Radboudumc Alzheimer Center, Nijmegen, The Netherlands.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa129']
2149,31806191,Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.,"BACKGROUND


Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group.
OBJECTIVES


The objective of this article was to perform an economic evaluation of the SENIOR trial.
METHODS


This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping.
RESULTS


A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries.
CONCLUSION


The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.",2019,The number of MACCEs and average QALYs were not statistically different between the 2 groups.,"['1200 patients underwent randomization', 'Elderly patients receive', '5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values', 'elderly patients', 'Elderly Patients With Coronary Artery Disease']","['DES', 'DAPT', 'bare metal stents instead of drug-eluting stents (DES', 'Drug-Eluting Stents']","['number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE', '1-year incremental cost-effectiveness ratio', 'number of MACCEs and average QALYs', 'incremental cost-effectiveness ratio', 'Cost-Effectiveness', 'average total cost per patient', 'Costs, MACCEs, and quality-adjusted life-years (QALYs']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1200.0,0.0487237,The number of MACCEs and average QALYs were not statistically different between the 2 groups.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bulsei', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France. Electronic address: julie.bulsei@urc-eco.fr.""}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Butel', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Varenne', 'Affiliation': 'AP-HP Hôpital Cochin, Paris, France; Cardiology Department, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Cardiology Department, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.07.008']
2150,31806193,Propensity Score Weighting Using Overlap Weights: A New Method Applied to Regorafenib Clinical Data and a Cost-Effectiveness Analysis.,"BACKGROUND


In situations of markedly different population characteristics and weak population overlap, inverse propensity score (PS) weights suffer from extreme values. The new propensity score weighting method using overlap weights (PSOW) overcomes this limitation by estimating the overlap population at the point of highest mutual overlap, thus may be preferred to other balancing methods (trimming, target, or inverse weights) in some situations.
OBJECTIVES


To evaluate the performance of PSOW with regorafenib effectiveness data from previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial (RCT) (placebo). The second goal was to assess the cost-effectiveness of regorafenib versus placebo.
METHODS


Individual data on progression-free survival (PFS)/overall survival (OS) were balanced via PSOW for age, sex, Eastern Cooperative Oncology Group performance status, number of treatment lines, metastatic colorectal cancer location, KRAS mutation, and time from metastases estimated using logistic regression. The weighted Kaplan-Meier PFS/OS curves were used in a 3-state partitioned survival model. The R code is provided.
RESULTS


In comparison with target or inverse PS weights, PSOW showed remarkable performance measured by effective sample size and PS weight distribution or extreme weights despite the weak overlap between the registry and RCT. In the registry or RCT cohort, regorafenib provided better survival compared with the RCT. The new PSOW hazard ratio for OS was 0.53 (RCT: 0.79), which is conservative compared with inverse or target weights with a hazard ratio of 0.44 and 0.27, respectively.
CONCLUSION


This is the first use of PSOW for clinical data and cost-effectiveness analysis. It is promising in cases of weak or small population overlap and makes pharmacoeconomic modeling, in such cases, feasible.",2019,The new PSOW hazard ratio for OS was 0.53,['previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial '],"['RCT) (placebo', 'regorafenib versus placebo']","['new PSOW hazard ratio for OS', 'Propensity Score Weighting Using Overlap Weights', 'progression-free survival (PFS)/overall survival (OS', 'survival', 'cost-effectiveness']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.204898,The new PSOW hazard ratio for OS was 0.53,"[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Mlcoch', 'Affiliation': 'Value Outcomes, Prague, Czech Republic. Electronic address: tomas.mlcoch@valueoutcomes.cz.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Hrnciarova', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tuzil', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Zadak', 'Affiliation': 'Bayer, Prague, Czech Republic.'}, {'ForeName': 'Marisca', 'Initials': 'M', 'LastName': 'Marian', 'Affiliation': 'Bayer Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Dolezal', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; Faculty of Medicine, Masaryk University, Department of Pharmacology, Brno, Czech Republic.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.06.010']
2151,32066412,Proof-of-concept study of the efficacy of a microbiota-directed complementary food formulation (MDCF) for treating moderate acute malnutrition.,"BACKGROUND


Childhood undernutrition remains a significant global health challenge accounting for over half of all under 5 child mortality. Moderate acute malnutrition (MAM), which leads to wasting [weight-for-length z-scores (WLZ) between - 2 and - 3], affects 33 million children under 5 globally and more than 2 million in Bangladesh alone. We have previously reported that acute malnutrition in this population is associated with gut microbiota immaturity, and in a small, 1-month pre-proof-of-concept (POC) study demonstrated that a microbiota-directed complementary food formulation (MDCF-2) was able to repair this immaturity, promote weight gain and increase plasma biomarkers and mediators of healthy growth. Here we describe the design controlled feeding study that tests whether MDCF-2 exhibits superior efficacy (ponderal growth, host biomarkers of a biological state) than a conventional Ready-to-use Supplementary Food (RUSF) in children with MAM over intervention period of 3 months.
METHODS


Two separate cohorts of 12-18-month-old children will be enrolled: 124 with primary MAM, and 124 with MAM after having been treated for severe acute malnutrition (post-SAM MAM). We have established several field sites in an urban slum located in the Mirpur district of Dhaka, Bangladesh and at a rural site, Kurigram in the north of Bangladesh. The two groups of children receiving MDCF-2 and RUSF will be compared at baseline (pre-intervention), after 1 month, at the end of intervention (3 months), 1 month after cessation of intervention, and every 6 months thereafter for 4 years.
DISCUSSION


This study will determine whether daily, controlled administration of MDCF-2 for 3 months provides superior improvements in weight gain, microbiota repair, and elevated levels of key plasma biomarkers/mediators of healthy growth compared to the control RUSF formulation. The pathogenesis of MAM is poorly defined and there are currently no WHO-approved treatments; results from the current study of children with primary MAM and post-SAM MAM will shed light on the effects of the gut microbiota on childhood growth/development and will provide a knowledge base that may help improve complementary feeding practices.
TRIAL REGISTRATION


The primary MAM and post-SAM MAM trials are registered in Clintrials.gov (NCT04015999 and NCT04015986, registered on July 11, 2019, retrospectively registered).",2020,"The two groups of children receiving MDCF-2 and RUSF will be compared at baseline (pre-intervention), after 1 month, at the end of intervention (3 months), 1 month after cessation of intervention, and every 6 months thereafter for 4 years.
","['moderate acute malnutrition', 'children with MAM over intervention period of 3\u2009months', '33 million children under 5 globally and more than 2 million in Bangladesh alone', 'Two separate cohorts of 12-18-month-old children will be enrolled: 124 with primary MAM, and 124 with MAM after having been treated for severe acute malnutrition (post-SAM MAM', 'urban slum located in the Mirpur district of Dhaka, Bangladesh and at a rural site, Kurigram in the north of Bangladesh']","['MDCF-2 and RUSF', 'MDCF-2', 'microbiota-directed complementary food formulation (MDCF', 'conventional Ready-to-use Supplementary Food (RUSF']","['weight gain, microbiota repair, and elevated levels of key plasma biomarkers/mediators of healthy growth', 'Moderate acute malnutrition (MAM']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]",,0.0394697,"The two groups of children receiving MDCF-2 and RUSF will be compared at baseline (pre-intervention), after 1 month, at the end of intervention (3 months), 1 month after cessation of intervention, and every 6 months thereafter for 4 years.
","[{'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Mostafa', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh. Ishita.mostafa@icddrb.org.'}, {'ForeName': 'Naila Nurun', 'Initials': 'NN', 'LastName': 'Nahar', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Md Munirul', 'Initials': 'MM', 'LastName': 'Islam', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Sayeeda', 'Initials': 'S', 'LastName': 'Huq', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Mahfuz', 'Initials': 'M', 'LastName': 'Mustafa', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barratt', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Gordon', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}]",BMC public health,['10.1186/s12889-020-8330-8']
2152,31622044,Adherence and acceptability of community-based distribution of micronutrient powders in Southern Mali.,"Home fortification with micronutrient powders (MNP) has been shown to reduce anaemia, with high overall acceptability and adherence, but there is limited evidence from West Africa. Around 80% of children younger than 5 years are anaemic in Mali, and new interventions are needed. This paper reports on the adherence and acceptability of a community-led MNP intervention targeting children aged 6-59 months in Southern Mali. The MNP were delivered by a multidisciplinary group of community volunteers using community-based preschools, cooking demonstrations, and traditional communication networks to promote MNP, nutrition, hygiene, and child stimulation. The MNP were delivered alongside early childhood development interventions and seasonal malaria chemoprevention. Adherence and acceptability were evaluated through two cross-sectional surveys in 2014 and 2016 and a qualitative evaluation in 2015. Over 80% of parents reported ever having given MNP to their child, with 65% having given MNP for four or more days in the last week. Likely contributors to uptake include: perceived positive changes in the children following MNP use, the selection of a food vehicle that was already commonly given to children (morning porridge or bouillie) and the community driven, decentralized and integrated delivery approach. These findings support recommendations from recent reviews of MNP implementation to use community-based delivery approaches and behaviour change components.",2019,"Home fortification with micronutrient powders (MNP) has been shown to reduce anaemia, with high overall acceptability and adherence, but there is limited evidence from West Africa.","['Southern Mali', 'children aged 6-59\xa0months in Southern Mali']","['Home fortification with micronutrient powders (MNP', 'community-led MNP intervention', 'community-based preschools, cooking demonstrations, and traditional communication networks to promote MNP, nutrition, hygiene, and child stimulation']",['Adherence and acceptability'],"[{'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.054655,"Home fortification with micronutrient powders (MNP) has been shown to reduce anaemia, with high overall acceptability and adherence, but there is limited evidence from West Africa.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Roschnik', 'Affiliation': 'Programme Quality and Policy, Save the Children UK, London, UK.'}, {'ForeName': 'Hawa', 'Initials': 'H', 'LastName': 'Diarra', 'Affiliation': 'Sponsorship programmes, Save the Children International, Bamako, Mali.'}, {'ForeName': 'Yahia', 'Initials': 'Y', 'LastName': 'Dicko', 'Affiliation': 'Sponsorship programmes, Save the Children International, Bamako, Mali.'}, {'ForeName': 'Seybou', 'Initials': 'S', 'LastName': 'Diarra', 'Affiliation': 'Sponsorship programmes, Save the Children International, Bamako, Mali.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Stanley', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Moestue', 'Affiliation': 'Department of Education and Child Protection, Save the Children USA, Washington, DC.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'McClean', 'Affiliation': 'Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Verhoef', 'Affiliation': 'Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sian E', 'Initials': 'SE', 'LastName': 'Clarke', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12831']
2153,32449942,Effects of Prazosin on Provoked Alcohol Craving and Autonomic and Neuroendocrine Response to Stress in Alcohol Use Disorder.,"BACKGROUND


Chronic alcohol results in changes to stress biology and autonomic arousal contributing to acute alcohol withdrawal symptoms, neuroendocrine tolerance of the hypothalamic-pituitary-adrenal (HPA) axis responses, high stress-induced craving, and risk of alcohol relapse. Thus, stress coping and recovery from alcohol during early abstinence may be jeopardized by such stress system dysfunction. Significant preclinical evidence suggests that noradrenergic disruption may contribute to these alcohol-related stress arousal changes and that alpha-1 adrenergic antagonists, such as prazosin, may normalize these stress system adaptations and reduce alcohol intake. Thus, we hypothesized that prazosin would reduce stress-induced craving and improve neuroendocrine and autonomic response to stress- and alcohol cue exposure during early abstinence. We secondarily also assessed the role of lifetime anxiety disorders on these prazosin effects.
METHODS


Forty inpatient treatment-seeking alcohol dependent individuals were randomly assigned to receive placebo (n=18) or 16mg/day, T.I.D., prazosin (n=22) in a double-blind manner, titrated over 2 weeks. In week 3-4 after achieving full dose, patients were exposed to three 5-minute personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue), on three consecutive days in a random, counterbalanced order. Alcohol craving, anxiety, heart rate, cortisol and ACTH levels were assessed at baseline, following imagery and at repeated recovery timepoints.
RESULTS


Prazosin reduced stress cue-induced alcohol craving (p<.05) and stress- and alcohol cue-induced anxiety (p<.05); and increased heart rate responses in all imagery conditions (p<.05). Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo. Finally, in those without lifetime anxiety disorder, the placebo group showed stress- and alcohol cue-induced increases in cortisol (p's<.05), while the prazosin group did not.
CONCLUSIONS


Prazosin may attenuate stress cue-induced alcohol craving and anxiety during early abstinence while improving adrenergic and stress system function, effects which are independent of a history of lifetime anxiety disorders.",2020,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.",['Forty inpatient treatment-seeking alcohol dependent individuals'],"['placebo', 'personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue', 'prazosin', 'Prazosin']","['stress cue-induced alcohol craving and anxiety', ""basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol"", 'stress cue-induced alcohol craving (p<.05) and stress- and alcohol cue-induced anxiety (p<.05); and increased heart rate responses', 'stress-induced craving and improve neuroendocrine and autonomic response', 'Alcohol craving, anxiety, heart rate, cortisol and ACTH levels', 'stress- and alcohol cue-induced increases in cortisol', 'Provoked Alcohol Craving and Autonomic and Neuroendocrine Response']","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.0290454,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.","[{'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Yale University School of Medicine, Dept. of Psychiatry, New Haven, CT, 06519, United States.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, Connecticut Mental Health Center, Yale University School of Medicine, Dept. of Psychiatry, New Haven, CT, 06519, United States.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'The Yale Stress Center, Yale University School of Medicine, Dept. of Psychiatry, New Haven, CT, 06519, United States.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Yale University School of Medicine, Dept. of Psychiatry, New Haven, CT, 06519, United States.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Stony Brook University School of Medicine, Dept. of Psychiatry, Stony Brook, NY, 11794, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14378']
2154,32449960,"Assessing consumers' understanding of the term ""Natural"" on food labeling.","The objective of this study was to gain a better understanding of how consumers' interpret the term ""natural"" by assessing food choice based on labels describing attributes of a product associated with the term ""natural""; to assess food intake of chosen food, and; to determine factors that influence food choice and intake. A randomized, single-visit pilot study was conducted where participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label. Participants were asked to choose and eat the granola (ad libitum) that coincided with what was closest to their view of ""natural."" Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness were measured. ""Organic"" (31%), ""Made with real grains"" (17%), and ""No preservatives"" (15%) were the top three chosen labels. These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049). Income level and age were significantly associated with choice (P = 0.003). Defining the term ""natural"" for use on food labels will require follow-up researchacrosseconomically diverse populations and age groups to understand expectations of food products bearing the term ""natural.""",2020,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).",['participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label'],[],"['Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",105.0,0.0447794,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).","[{'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zasadzinski', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}]",Journal of food science,['10.1111/1750-3841.15128']
2155,32450057,Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial.,"BACKGROUND


Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding.
METHODS


Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days.
RESULTS


In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; P interaction  = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; P interaction  = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant.
CONCLUSIONS


Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.",2020,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","['Percutaneous Coronary Intervention', 'patients with acute coronary syndromes', 'Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score']",[],"['radial and femoral artery access', 'secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding', 'mortality and bleeding events', 'bleeding risk strata', 'mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access', 'secondary safety', 'composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],"[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.402974,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Kostkowice, Poland; Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron, Poland.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Cardiology Division. Department of Internal Medicine, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Division of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Christoph Kurt', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Cardiology B Department, Centre Hospitalier Universitaire de Rangueil, Université Toulouse, Toulouse, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""Hôpital Bichat, l'Assistance Publique-Hôpitaux de Paris, Université Paris-Diderot, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom.""}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Robert-Jan van', 'Initials': 'RV', 'LastName': 'Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Department of Cardiology, National University of Ireland, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'Andrzej Frycz Modrzewski Krakow University, Krakow, Poland; American Heart of Poland, Chrzanow, Poland.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.029']
2156,32450063,Comparison of removable rigid dressing and elastic bandage for residual limb maturation in transtibial amputees: a randomized controlled trial.,"OBJECTIVE


To determine the effect of a removable rigid dressing (RRD) on the time to residual limb maturation compared with elastic bandage (EB) in transtibial amputees.
DESIGN


Experimental single-blinded (assessor-blinded) randomized controlled trial.
SETTING


Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital.
PARTICIPANTS


Twenty-five transtibial amputees with immature residual limb.
INTERVENTIONS


Participants were allocated to use RRD or EB to achieve residual limb maturation, and all participants in both groups were trained with the same pre-prosthetic program.
MAIN OUTCOME MEASURES


The time to residual limb maturation, patient satisfaction and complications were compared between the two groups.
RESULTS


Median time to residual limb maturation was significantly lower in the RRD group (28 days, IQR: 17-51 days) than in the EB group (54 days, IQR: 30-77 days; P=0.020). After accounting for time since amputation, maturation time remained significantly lower in the RRD group (adjusted HR=3.32, 95%CI: 1.08 to 10.20; P=0.036). There was no significant difference in complications or patient satisfaction.
CONCLUSION


In post-operative management of transtibial amputation, the use of RRD had a significantly shorter period to residual limb maturation when compared with EB group.",2020,"There was no significant difference in complications or patient satisfaction.
","['Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital', 'Twenty-five transtibial amputees with immature residual limb', 'transtibial amputees']","['removable rigid dressing (RRD', 'elastic bandage (EB', 'removable rigid dressing and elastic bandage', 'RRD or EB']","['residual limb maturation', 'time to residual limb maturation, patient satisfaction and complications', 'time since amputation, maturation time', 'complications or patient satisfaction', 'Median time to residual limb maturation']","[{'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.126639,"There was no significant difference in complications or patient satisfaction.
","[{'ForeName': 'Nantawan', 'Initials': 'N', 'LastName': 'Koonalinthip', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross society, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: col_kate@hotmail.com.'}, {'ForeName': 'Aungsumalin', 'Initials': 'A', 'LastName': 'Sukthongsa', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Siriporn', 'Initials': 'S', 'LastName': 'Janchai', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.009']
2157,32450080,Access to Single-Visit IUD Insertion at Obstetrician-Gynecology Practices in Ohio: An Audit Study.,"OBJECTIVE


Single-visit intrauterine device (IUD) insertion protocols are recommended. We assessed the availability of single-visit IUD insertions, and whether access to these services varies by age, race or parity. Study Design Using audit study methodology, we called a random sample of 396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment. Callers used eight standardized scripts and noted justifications for protocols offered by clinic staff. Practices were randomized to follow a balanced 3x2 factorial design, whereby practices were assigned to one of two conditions: (1) age (18 vs. 30 years of age); (2) race (white vs. black); and (3) parity. Multivariable logistic regression was used to control for clinics rural vs. urban location while considering the effects of these variables on service provision.
RESULTS


Almost all (95%) of the practices called offered IUD placement, of which 92% required multiple appointments for IUD insertion. Although access to single-visit IUD services did not vary by age or race, we found that parity was associated with clinics' willingness to schedule a single-visit insertion visit (OR=3.84, 95% CI=1.23, 12.04). The most frequent justification provided by clinic staff for their multiple-appointment protocol was the need to verify insurance coverage or order the device directly through the patient's insurance company.
CONCLUSION


Ohio patients seeking IUD placement must typically make more than one clinic visit. Implications Efforts are needed to reassure Ohio clinics that IUDs are routinely covered by insurers and to increase access to same-day IUD placement for women in Ohio, as the requirement to attend multiple clinics appointments to obtain a desired contraceptive may pose an insurmountable barrier to care for those with the fewest resources.",2020,"RESULTS


Almost all (95%) of the practices called offered IUD placement,",['396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment'],[],[],"[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],[],396.0,0.233788,"RESULTS


Almost all (95%) of the practices called offered IUD placement,","[{'ForeName': 'Jaclyn J', 'Initials': 'JJ', 'LastName': 'Serpico', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH, 43210, USA; The Ohio State University, College of Arts and Sciences, Columbus, OH, 43210, USA. Electronic address: jaclynjserpico@gmail.com.'}, {'ForeName': 'JaNelle M', 'Initials': 'JM', 'LastName': 'Ricks', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH, 43210, USA.'}, {'ForeName': 'Wendy G', 'Initials': 'WG', 'LastName': 'Smooth', 'Affiliation': 'The Ohio State University, College of Arts and Sciences, Columbus, OH, 43210, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Romanos', 'Affiliation': 'Planned Parenthood of Greater Ohio, Columbus, OH, 43215, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Brook', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH, 43210, USA; The Ohio State University Wexner Medical Center, Medical Scientist Training Program, Columbus, OH, 43210, USA.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallo', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH, 43210, USA.'}]",Contraception,['10.1016/j.contraception.2020.05.007']
2158,32450083,Randomized matrix games in a finite population: Effect of stochastic fluctuations in the payoffs on the evolution of cooperation.,"A diffusion approximation for a randomized 2 × 2-matrix game in a large finite population is ascertained in the case of random payoffs whose expected values, variances and covariances are of order given by the inverse of the population size N. Applying the approximation to a Randomized Prisoner's Dilemma (RPD) with independent payoffs for cooperation and defection in random pairwise interactions, conditions on the variances of the payoffs for selection to favor the evolution of cooperation, favor more the evolution of cooperation than the evolution of defection, and disfavor the evolution of defection are deduced. All these are obtained from probabilities of ultimate fixation of a single mutant. It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection. A RPD game with independent payoffs whose expected values are additive is studied in detail to support the conclusions. Randomized matrix games with non-independent payoffs, namely the RPD game with additive payoffs for cooperation and defection based on random cost and benefit for cooperation and the repeated RPD game with Tit-for-Tat and Always-Defect as strategies in pairwise interactions with a random number of rounds, are studied under the assumption that the population-scaled expected values, variances and covariances of the payoffs are all of the same small enough order. In the first model, the conditions in favor of the evolution of cooperation hold only if the covariance between the cost and the benefit is large enough, while the analysis of the second model extends the results on the effects of the variances of the payoffs for cooperation and defection found for the one-round RPD game.",2020,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,[],[],[],[],[],[],,0.0254081,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada. Electronic address: lessards@dms.umontreal.ca.'}]",Theoretical population biology,['10.1016/j.tpb.2020.04.006']
2159,32450102,Prevalence of Microvascular and Macrovascular Disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study Cohort.,"AIMS


The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry.
METHODS


Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications.
RESULTS


We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean knownT2D duration 4 years (all<10 years); mean HbA1c 8.0% (∼64mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%.
CONCLUSIONS


In the GRADE cohort with <10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.",2020,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"['5047 T2D participants [mean age 57 years; 36% female; mean knownT2D duration 4 years (all<10 years); mean', 'Diabetes ', 'type 2 diabetes (T2D']",['metformin'],"['peripheral neuropathy', 'diabetes complications', 'Myocardial infarction ascertained by self-report or electrocardiogram', 'Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram', 'cardiovascular autonomic neuropathy']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}]",5047.0,0.0726804,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"[{'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, Indiana University School of Medicine, Indianapolis IN.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. Electronic address: grademail@bsc.gwu.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Cincinnati College of Medicine & Endocrine Section, Cincinnati VA Medical Center, Cincinnati OH.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Division of Endocrinology and Fleischer Institute for Diabetes & Metabolism, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Division of Diabetes, Endocrinology & Metabolism, University of Nebraska College of Medicine, Omaha, NE.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sue Kirkman', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston MA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of California, San Diego, CA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Seaquist', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, University of Minnesota Medical School, Minneapolis MN.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention and Department of Internal Medicine-Cardiology Section, Wake Forest School of Medicine, Winston Salem, NC.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston MA.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108235']
2160,32450106,"Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.","BACKGROUND


A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
METHODS


We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 10 10 , 1 × 10 11 , and 1·5 × 10 11  viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127.
FINDINGS


Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.
INTERPRETATION


The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.
FUNDING


National Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.",2020,"Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination.","['108 participants (51% male, 49% female; mean age 36·3 years', 'Between March 16 and March 27, 2020', 'Healthy adults aged between 18 and 60 years', '195 individuals for eligibility', '×\u200810 11 , and 1·5', 'healthy adults', '10 10 , 1']","['recombinant adenovirus type-5', 'recombinant adenovirus type-5 vectored COVID-19 vaccine', 'vaccine', 'intramuscular injection of vaccine']","['headache', 'muscle pain', 'Safety', 'T-cell responses', 'adverse reaction', 'fatigue', 'safety, tolerability, and immunogenicity', 'Safety, tolerability, and immunogenicity', 'Specific T-cell response', 'rapid specific T-cell responses', 'ELISA antibodies and neutralising antibodies', 'serious adverse event', 'Humoral responses against SARS-CoV-2', 'adverse events', 'Specific antibodies']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",,0.455423,"Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination.","[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'China National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Xu-Hua', 'Initials': 'XH', 'LastName': 'Guan', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Hou', 'Affiliation': 'Beijing Institute of Biotechnology, Beijing, China.'}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jing-Xin', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Shi-Po', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Biotechnology, Beijing, China.'}, {'ForeName': 'Bu-Sen', 'Initials': 'BS', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biotechnology, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Si-Yue', 'Initials': 'SY', 'LastName': 'Jia', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hu-Dachuan', 'Initials': 'HD', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'China National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics, Tianjin, China.'}, {'ForeName': 'Sha-Bei', 'Initials': 'SB', 'LastName': 'Xu', 'Affiliation': 'Clinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'Beijing Institute of Biotechnology, Beijing, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Wang', 'Affiliation': 'Shanghai Canming Medical Technology, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Beijing Institute of Biotechnology, Beijing, China. Electronic address: cw0226@foxmail.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31208-3']
2161,32450154,"After ten years of follow-up, no difference between supportive care plus immunosuppression and supportive care alone in IgA nephropathy.","The randomized, controlled STOP-IgAN trial in patients with IgA nephropathy (IgAN) and substantial proteinuria showed no benefit of immunosuppression added on top of supportive care on renal function over three years. As a follow-up we evaluated renal outcomes in patients over a follow-up of up to ten years in terms of serum creatinine, proteinuria, end-stage kidney disease (ESKD), and death. The adapted primary endpoint was the time to first occurrence of a composite of death, ESKD, or a decline of over 40% in the estimated glomerular filtration rate (eGFR) compared to baseline at randomization into STOP-IgAN. Data were analyzed by Cox-regression models. Follow-up data were available for 149 participants, representing 92% of the patients originally randomized. Median follow-up was 7.4 years (inter quartile range 5.7 to 8.3 years). The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92). ESKD occurred in 17 of the patients with supportive care and in 20 of the patients with additional immunosuppression. Additionally, the rates of eGFR loss over 40% and annual eGFR loss did not differ between groups. Two patients died with supportive-care and three with additional immunosuppression. Thus, within the limitations of a retrospective study, over a follow-up of up to ten years and using an adapted primary endpoint, we failed to detect differences in key clinical outcomes in IgAN patients randomized to receive added immunosuppression on top of supportive care versus supportive care alone.",2020,The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92).,"['149 participants, representing 92% of the patients originally randomized', 'Two patients died with supportive-care and three with additional immunosuppression', 'patients with IgA nephropathy (IgAN) and substantial proteinuria showed no benefit of immunosuppression added on top of supportive care on renal function over three years']","['additional immunosuppression', 'added immunosuppression on top of supportive care versus supportive care alone']","['rates of eGFR loss', 'serum creatinine, proteinuria, end-stage kidney disease (ESKD), and death', 'ESKD', 'annual eGFR loss', 'time to first occurrence of a composite of death, ESKD, or a decline of over 40% in the estimated glomerular filtration rate (eGFR']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",149.0,0.0959926,The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauen', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fitzner', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eitner', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany;; Bayer AG, Kidney Diseases Research, Wuppertal, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology and Renal Center Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zeier', 'Affiliation': 'Department of Nephrology and Renal Center Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Otte', 'Affiliation': 'Internal Medicine D, Department of Nephrology, Hypertension and Rheumatology, University, Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Panzer', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Budde', 'Affiliation': 'Department of Nephrology, Charité Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Benck', 'Affiliation': 'Department of Medicine V, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Mertens', 'Affiliation': 'Department of Nephrology and Hypertension, Diabetes and Endocrinology, Otto-von-Guericke, University, Magdeburg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Kuhlmann', 'Affiliation': 'Medical Clinic III, Central Hospital Bremen, Bremen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Goettingen, Goettingen, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Vielhauer', 'Affiliation': 'Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, LMU München, Munich, Germany.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center Munich-Schwabing and Dept. of Medicine IV, Univ. of Erlangen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany;. Electronic address: jfloege@ukaachen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.04.046']
2162,32450215,Ergonomical assessment of three-dimensional versus two-dimensional thoracoscopic lobectomy.,"In this study we compared ergonomical domains characteristics of three dimensional (3D) versus two dimensional (2D) video-systems in thoracoscopic lobectomy using a scoring-scale-based assessment. Seventy patients (mean age, 69±6.9 years, 43 males and 27 females) with early stage lung cancer were randomized to undergo thoracoscopic lobectomy by either 3D (N=35) or 2D (N=35) video-systems. All operations were divided into 5 standardized surgical steps (vein, artery, bronchus, fissure, lymph nodes), which were evaluated by 4 thoracic surgeons using a scoring scale (score range from 1,unsatisfactory to 3,excellent) entailing assessment of 3 ergonomical domains: exposure, instrumentation and maneuvering. Primary outcome was a difference ≥10% in the maneuvering domain steps. At intergroup comparisons, there was no difference in demographics. The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score≥10%, p≤0.006). Other significant differences included exposure of the vein, artery and bronchus (p≤0.03). Results favoring the 2D system included maneuvering, exposure and instrumentation of the fissure (p=0.001). Inter-rater concordance of ergonomics scoring was satisfactory (Cronbach's α range, 0.85-0.88). Operative time was significantly shorter in the 3D group (127±19min versus 143±18min, p=0.001) whereas there was no difference in hospital stay (3.4±1.2 versus 4.1±1.6days, p=0.07). In this study comparison of ergonomic domains scoring in 3D vs 2D thoracoscopic lobectomy favored the 3D system for the maneuvering total score, which proved inversely correlated with operative times possibly due to a better perception of depth and more precise surgical maneuvering.",2020,"The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score≥10%, p≤0.006).","['Seventy patients (mean age, 69±6.9 years, 43 males and 27 females) with early stage lung cancer']","['three dimensional (3D) versus two dimensional (2D) video-systems in thoracoscopic lobectomy', 'thoracoscopic lobectomy by either 3D (N=35) or 2D (N=35) video-systems', 'ergonomic domains scoring in 3D vs 2D thoracoscopic lobectomy', 'dimensional thoracoscopic lobectomy']","['maneuvering domain steps', 'Operative time', 'maneuvering, exposure and instrumentation of the fissure', 'exposure of the vein, artery and bronchus (p≤0.03', 'hospital stay']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0006255', 'cui_str': 'Bronchial structure'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",70.0,0.0379695,"The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score≥10%, p≤0.006).","[{'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Elkhouly', 'Affiliation': 'Department of cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sorge', 'Affiliation': 'Departments of Biostatistics, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rogliani', 'Affiliation': 'Respiratory Medicine, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Cristino', 'Affiliation': 'Thoracic Surgery, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Wahby', 'Affiliation': 'Department of cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Serag', 'Affiliation': 'Department of cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pompeo', 'Affiliation': 'Thoracic Surgery, Policlinico Tor Vergata University, Rome, Italy. Electronic address: pompeo@med.uniroma2.it.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.05.018']
2163,32450273,Effect of postural training using a whole-body tilt apparatus in subacute stroke patients with lateropulsion: a single-blinded randomized controlled trial.,"BACKGROUND


Lateropulsion after stroke is defined as a postural bias toward the paretic side and push away from the non-paretic side. New rehabilitation techniques and programs should be designed to attenuate lateropulsion and improve functions of balance and gait.
OBJECTIVE


This study aimed to determine the effects of whole-body tilting postural training (WTPT) using a Spine Balance 3D on lateropulsion and postural control as compared with general postural training (GPT). Postural training was performed and involved a whole-body tilt apparatus that enables postural training in the tilted position, in multiple directions.
METHODS


This was a pragmatic, single-blind, randomized controlled trial conducted between June 2018 and May 2019. We randomly allocated 30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score >0) to experimental (n=15) and control (n=15) groups. The experimental group received WTPT with a whole-body tilt apparatus, and the control group GPT. WTPT was performed with the Spine Balance 3D and GPT with postural training commonly applied in the clinic. All participants received treatment for 30 min/session, 2 times/day, 5 days/week for 3 weeks. The primary outcome measure was lateropulsion assessed with the Burke Lateropulsion Scale (BLS). Secondary outcome measures were postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score.
RESULTS


For the primary outcome, after training, BLS scores were decreased more for the experimental than control group (Δ = -5.8 vs Δ = -4.2, P=0.002). For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
CONCLUSIONS


WTPT is a potentially effective therapeutic intervention for lateropulsion recovery in patients with subacute stroke. It may be useful for improving postural control and activities of daily living.",2020,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","['patients with subacute stroke', 'June 2018 and May 2019', '30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score >0) to experimental (n=15) and control (n=15) groups', 'subacute stroke patients with lateropulsion']","['WTPT with a whole-body tilt apparatus, and the control group GPT', 'whole-body tilting postural training (WTPT', 'general postural training (GPT', 'WTPT', 'postural training', 'Postural training was performed and involved a whole-body tilt apparatus that enables postural training']","['postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score', 'lateropulsion assessed with the Burke Lateropulsion Scale (BLS', 'BBS', 'BLS scores', 'K-MBI', 'postural control and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.0509118,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","[{'ForeName': 'Chang-Man', 'Initials': 'CM', 'LastName': 'An', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 54907 Jeonju, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 54907 Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, 54907 Jeonju, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, 54907 Jeonju, Republic of Korea.'}, {'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 54907 Jeonju, Republic of Korea.'}, {'ForeName': 'Gi-Wook', 'Initials': 'GW', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 54907 Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, 54907 Jeonju, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, 54907 Jeonju, Republic of Korea. Electronic address: k26@jbnu.ac.kr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.001']
2164,32450367,Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.,"Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.",2020,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","['150 participants (76.1% female, 55.8% white, BMI\u202f=\u202f38.8\u202f±\u202f4.8\u202fkg/m 2 ']","['intensive behavioral therapy (IBT', 'IBT alone, IBT with liraglutide 3.0\u202fmg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'liraglutide']","['Early weight loss', 'weight loss', 'total weight loss', 'visit attendance, dietary self-monitoring, medication, and meal-replacement adherence', 'self-monitoring and medication adherence', 'medication adherence']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",150.0,0.0213041,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, USA.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103639']
2165,32450456,The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial.,"BACKGROUND AND AIMS


The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial.
METHODS AND RESULTS


The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies.
CONCLUSIONS


Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the ""all-comer"" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.",2020,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","['patients undergoing percutaneous coronary intervention', 'patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial']",['percutaneous coronary intervention (PCI'],"['PHR and BARC 3 or 5 bleeding', 'primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5', 'PHR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",,0.296061,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","[{'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Klinikum Fulda, Medizinische Klinik I, Fulda, Germany.'}, {'ForeName': 'Gincho', 'Initials': 'G', 'LastName': 'Tonev', 'Affiliation': ""Multi-profile Hospital for Active Treatment, St George's University, Plovdiv, Bulgaria.""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eeckhout', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Van Geuns', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.04.010']
2166,32450497,Effect of brexpiprazole on control of impulsivity in schizophrenia: A randomized functional magnetic resonance imaging study.,"Impulsivity in schizophrenia is a risk factor for suicide, drug abuse, and other risk-taking behaviors. This exploratory, multicenter, randomized, double-blind, functional magnetic resonance imaging (fMRI) study assessed the effects of brexpiprazole on brain regions that control impulsive behavior. Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms were randomized to 6 weeks of brexpiprazole 2 or 4 mg/day. The prespecified outcome measure was blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task. Secondary objectives evaluated the efficacy, safety and tolerability of brexpiprazole. Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task. Brexpiprazole was also associated with significantly improved stop-signal reaction time (SSRT). No worsening of psychiatric symptoms, functioning, or impulsivity occurred in these patients. No unexpected safety or tolerability concerns were identified. In conclusion, brexpiprazole treatment among patients with schizophrenia and impulsivity was associated with decreased right VLPFC activation and decreased SSRT, supportive of a benefit of brexpiprazole on inhibition-related brain activation and behavior. ClinicalTrials.gov identifier: NCT02194933.",2020,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","['Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms', 'schizophrenia', 'patients with schizophrenia and impulsivity']","['brexpiprazole', 'functional magnetic resonance imaging (fMRI', 'Brexpiprazole']","['blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task', 'right VLPFC BOLD activation', 'safety or tolerability concerns', 'right VLPFC activation', 'psychiatric symptoms, functioning, or impulsivity', 'efficacy, safety and tolerability of brexpiprazole', 'stop-signal reaction time (SSRT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",38.0,0.07473,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","[{'ForeName': 'Theo Gm', 'Initials': 'TG', 'LastName': 'van Erp', 'Affiliation': 'Clinical and Translational Neuroscience Laboratory, University of California-Irvine, Irvine, CA, United States; Center for the Neurobiology of Learning and Memory, University of California-Irvine, Irvine, CA, United States. Electronic address: tvanerp@uci.edu.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okame', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, IL, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'University of California-Irvine, Irvine, CA, United States; Tibor Rubin Veterans Affairs Medical Center, Long Beach, CA, United States. Electronic address: sgpotkin@gmail.com.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111085']
2167,32450626,Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies.,"Background/Aims


The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in a global clinical trial programme. This post hoc analysis assesses the efficacy and safety of mepolizumab in Korean patients.
Methods


Data from Korean patients in the Phase III, placebo-controlled, randomised DREAM (MEA112997/NCT01000506) and MENSA (MEA115588/ NCT01691521) studies were included. Patients ≥ 12 years old with severe eosinophilic asthma received mepolizumab (DREAM: 75, 250 or 750 mg intravenously [IV]; MENSA: 75 mg IV or 100 mg subcutaneously [SC]), or placebo every 4 weeks for 52 weeks (DREAM) or 32 weeks (MENSA). The primary outcome was the rate of clinically significant asthma exacerbations. Secondary outcomes included forced expiratory volume in 1 second (FEV 1 ), Asthma Control Questionnaire (ACQ) and St George's Respiratory Questionnaire (SGRQ) scores (MENSA only). Blood eosinophil counts (BEC) and safety were assessed throughout.
Results


Reductions in the rate of clinically significant asthma exacerbations were observed with the approved (100 mg SC) and bioequivalent (75 mg IV) doses of mepolizumab in Korean patients who participated in DREAM and MENSA. In MENSA, trends for improvements from baseline at week 32 in pre-bronchodilator FEV 1  (75 mg IV group), ACQ-5 and SGRQ scores (in both treatment groups) were seen versus placebo in Korean patients. Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC.
Conclusions


Mepolizumab treatment provided clinical benefits for Korean patients with severe eosinophilic asthma; the safety profile is consistent with the overall population.",2020,"Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC.
","['Korean patients with severe eosinophilic asthma', 'Korean patients who participated in DREAM and MENSA', 'Patients ≥ 12 years old with severe eosinophilic asthma', 'Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies', 'Korean patients', 'patients with severe eosinophilic asthma']","['mepolizumab (DREAM', 'MENSA ', 'MENSA: 75 mg IV or 100 mg subcutaneously [SC]), or placebo', 'Mepolizumab', 'mepolizumab', 'placebo']","['Incidence of on-treatment adverse events', ""forced expiratory volume in 1 second (FEV 1 ), Asthma Control Questionnaire (ACQ) and St George's Respiratory Questionnaire (SGRQ) scores (MENSA only"", 'Efficacy and safety', 'efficacy and safety', 'rate of clinically significant asthma exacerbations', 'Blood eosinophil counts (BEC) and safety', 'ACQ-5 and SGRQ scores']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",,0.275304,"Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC.
","[{'ForeName': 'Mi-Kyeong', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Hae-Sim', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Choon-Sik', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Department of Pulmonology and Allergy, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Soung-Jun', 'Initials': 'SJ', 'LastName': 'Min', 'Affiliation': 'Respiratory Medical, GSK Korea, Seoul, Korea.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Global Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Bhabita', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Clinical Statistics, GSK, Uxbridge, UK.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Kwon', 'Affiliation': 'Respiratory Medical Franchise, GSK, Brentford, UK.'}]",The Korean journal of internal medicine,['10.3904/kjim.2019.198']
2168,32450720,Five-year results of viscotrabeculotomy versus conventional trabeculotomy in primary congenital glaucoma: A randomized controlled study.,"PURPOSE


To assess the long-term results of viscotrabeculotomy in infants with primary congenital glaucoma and to compare its outcome with conventional trabeculotomy.
PATIENTS AND METHODS


A prospective randomized comparative study included infants with primary congenital glaucoma younger than 2 years. Patients were divided into two groups: viscotrabeculotomy group and conventional trabeculotomy group. Preoperative and postoperative intraocular pressures, corneal diameter, intraoperative and postoperative complications, and success rates were compared between two groups. All the patients were followed up for 5 years.
RESULTS


The study included 154 eyes of 92 infants distributed randomly among the two groups; 78 and 76 eyes in viscotrabeculotomy and conventional trabeculotomy groups, respectively. In both groups, there was a statistically significant intraocular pressure reduction at all time points of the follow-up periods compared to the preoperative values (p < 0.0001). At 5 years, viscotrabeculotomy group showed significant reduction of the mean postoperative intraocular pressure (49.47%) than conventional trabeculotomy group (48.64%) (p < 0.0001). Intraocular pressure was statistically lower in viscotrabeculotomy starting from 12th month and till the end of the follow-up. At 5 years, the total success rate of viscotrabeculotomy group was 89.74% compared to 85.53% in conventional trabeculotomy group without significant difference (p = 0.487). The postoperative mean values of the cup/disk ratio in viscotrabeculotomy group showed statistically lower values compared to conventional trabeculotomy group (p = 0.019). Postoperative hyphema was statistically higher in conventional trabeculotomy group (p < 0.0001). All eyes that underwent a reoperation before 5 years follow-up were excluded from the statistical workup of the study after reoperation, except for calculation of success/failure.
CONCLUSION


Viscotrabeculotomy and conventional trabeculotomy proved to be effective in cases of primary congenital glaucoma. Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.",2020,Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.,"['infants with primary congenital glaucoma younger than 2 years', '154 eyes of 92 infants distributed randomly among the two groups; 78 and 76 eyes in', 'primary congenital glaucoma', 'infants with primary congenital glaucoma']","['conventional trabeculotomy', 'viscotrabeculotomy and conventional trabeculotomy', 'Viscotrabeculotomy and conventional trabeculotomy', 'Viscotrabeculotomy', 'viscotrabeculotomy group and conventional trabeculotomy group', 'viscotrabeculotomy']","['intraocular pressure reduction', 'Postoperative hyphema', 'postoperative mean values of the cup/disk ratio', 'Preoperative and postoperative intraocular pressures, corneal diameter, intraoperative and postoperative complications, and success rates', 'mean postoperative intraocular pressure', 'Intraocular pressure', 'total success rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0429514', 'cui_str': 'Corneal diameter'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",154.0,0.0433806,Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elwehidy', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Bayoumi', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ayman E', 'Initials': 'AE', 'LastName': 'AbdelGhafar', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Amani E', 'Initials': 'AE', 'LastName': 'Badawi', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",European journal of ophthalmology,['10.1177/1120672120922453']
2169,32450733,Surgical Field Visualization during Functional Endoscopic Sinus Surgery: Comparison of Propofol- vs Desflurane-Based Anesthesia.,"OBJECTIVE


To assess if the type of general anesthetic affects bleeding and field visualization during endoscopic sinus surgery.
STUDY DESIGN


Prospective, randomized, controlled trial.
SETTING


Academic teaching hospital and Veterans Affairs hospital in the United States.
SUBJECTS AND METHODS


Seventy patients were randomized to 1 of 3 anesthetic regimens: (1) the volatile anesthetic desflurane (n = 22), (2) intravenous anesthesia with propofol (n = 25), or (3) a combination of propofol and desflurane (n = 23). Intravenous remifentanil was titrated to decrease the mean arterial pressure to 60 to 70 mm Hg but not ≥30% from baseline. Surgical bleeding scores were recorded along with bleeding rates and hemodynamic parameters, including cardiac output and systemic vascular resistance through pulse contour analysis from a radial arterial line. Statistics: multiple comparison tests and regression analyses; α = .05.
RESULTS


There were no differences in bleeding rate (median, 0.58, 0.85, 0.57 mL min -1 ), bleeding score (2.1, 2.0, 2.0), surgery duration (79, 81, 86 minutes), extubation time (9, 7, 8 minutes), recovery room time (65, 61, 61 minutes), or any hemodynamic parameters among groups 1 through 3, respectively. Group 1 required lower remifentanil infusions than group 2 (0.11 vs 0.26 µg kg -1  min -1 ;  P  = .01). The bleeding score correlated positively with height ( P  = .014) and the Lund-MacKay score ( P  = .013). Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
CONCLUSION


When remifentanil is used for controlled hypotension, propofol has no advantage over desflurane to improve surgical field visualization during functional endoscopic sinus surgery.",2020,"Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
","['Academic teaching hospital and Veterans Affairs hospital in the United States', 'Functional Endoscopic Sinus Surgery', 'Seventy patients']","['Intravenous remifentanil', 'propofol and desflurane', 'intravenous anesthesia with propofol', 'Propofol- vs Desflurane-Based Anesthesia', 'volatile anesthetic desflurane', 'remifentanil', 'desflurane']","['longer surgery duration', 'bleeding rate', 'bleeding score', 'recovery room time', 'mean arterial pressure', 'Surgical bleeding scores', 'extubation time', 'Lund-MacKay score', 'cardiac output and systemic vascular resistance through pulse contour analysis from a radial arterial line', 'surgery duration']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}]",70.0,0.0604682,"Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
","[{'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Gollapudy', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Drake A', 'Initials': 'DA', 'LastName': 'Gashkoff', 'Affiliation': 'Medical School, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Poetker', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Loehrl', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Matthias L', 'Initials': 'ML', 'LastName': 'Riess', 'Affiliation': 'Anesthesiology, TVHS VA Medical Center, Nashville, Tennessee, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820921863']
2170,32450737,SimTube: A National Simulation Training and Research Project.,"OBJECTIVE


To test the feasibility and impact of a simulation training program for myringotomy and tube (M&T) placement.
STUDY DESIGN


Prospective randomized controlled.
SETTING


Multi-institutional.
SUBJECTS AND METHODS


An M&T simulator was used to assess the impact of simulation training vs no simulation training on the rate of achieving competency. Novice trainees were assessed using posttest simulator Objective Structured Assessment of Technical Skills (OSATS) scores, OSATS score for initial intraoperative tube insertion, and number of procedures to obtain competency. The effect of simulation training was analyzed using χ 2  tests, Wilcoxon-Mann-Whitney tests, and Cox proportional hazards regression.
RESULTS


A total of 101 residents and 105 raters from 65 institutions were enrolled; however, just 63 residents had sufficient data to be analyzed due to substantial breaches in protocol. There was no difference in simulator pretest scores between intervention and control groups; however, the intervention group had better OSATS global scores on the simulator (17.4 vs 13.7,  P  = .0003) and OSATS task scores on the simulator (4.5 vs 3.6,  P  = .02). No difference in OSATS scores was observed during initial live surgery rating ( P  = .73 and  P  = .41). OSATS scores were predictive of the rate at which residents achieved competence in performing myringotomy; however, the intervention was not associated with subsequent OSATS scores during live surgeries ( P  = .44 and  P  = .91) or the rate of achieving competence ( P  = .16).
CONCLUSIONS


A multi-institutional simulation study is feasible. Novices trained using the M&T simulator achieved higher scores on simulator but not initial intraoperative OSATS, and they did not reach  competency  sooner than those not trained on the simulator.",2020,"There was no difference in simulator pretest scores between intervention and control groups; however, the intervention group had better OSATS global scores on the simulator (17.4 vs 13.7,  P  = .0003) and OSATS task scores on the simulator (4.5 vs 3.6,  P  = .02).","['A total of 101 residents and 105 raters from 65 institutions were enrolled; however, just 63 residents had sufficient data to be analyzed due to substantial breaches in protocol']","['simulation training', 'M&T simulator', 'simulation training vs no simulation training', 'simulation training program for myringotomy and tube (M&T) placement']","['OSATS scores', 'rate of achieving competence', 'simulator pretest scores', 'OSATS global scores', 'OSATS task scores', 'posttest simulator Objective Structured Assessment of Technical Skills (OSATS) scores, OSATS score for initial intraoperative tube insertion, and number of procedures to obtain competency']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]",,0.0765416,"There was no difference in simulator pretest scores between intervention and control groups; however, the intervention group had better OSATS global scores on the simulator (17.4 vs 13.7,  P  = .0003) and OSATS task scores on the simulator (4.5 vs 3.6,  P  = .02).","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Wiet', 'Affiliation': ""Department of Otolaryngology, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Deutsch', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Malekzadeh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Onwuka', 'Affiliation': ""Center for Surgical Outcomes Research and Center for Innovation in Pediatric Practice, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Callender', 'Affiliation': 'College of Medicine, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Seidman', 'Affiliation': 'AdventHealth Medical Group, Otolaryngology-Head & Neck Surgery, Celebration, Florida, USA.'}, {'ForeName': 'Marvin P', 'Initials': 'MP', 'LastName': 'Fried', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Montefiore Medical Center and the Albert Einstein College of Medicine Bronx, New York, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820920833']
2171,32450831,Emerging pesticides responsible for suicide in rural Sri Lanka following the 2008-2014 pesticide bans.,"BACKGROUND


Sri Lanka has reduced its overall suicide rate by 70% over the last two decades through means restriction, through a series of government regulations and bans removing highly hazardous pesticides from agriculture. We aimed to identify the key pesticide(s) now responsible for suicides in rural Sri Lanka to provide data for further pesticide regulation.
METHODS


We performed a secondary analysis of data collected prospectively during a cluster randomized controlled trial in the Anuradhapura district of Sri Lanka from 2011 to 16. The identity of pesticides responsible for suicides were sought from medical or judicial medical notes, coroners' records, and the person's family. Trend analysis was done using a regression analysis with curve estimation to identify relative importance of key pesticides.
RESULTS


We identified 337 suicidal deaths. Among them, the majority 193 (57.3%) were due to ingestion of pesticides while 82 (24.3%) were due to hanging. A specific pesticide was identified in 105 (54.4%) of the pesticide suicides. Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides. The increasing trend of suicides due to carbosulfan and profenofos over time was statistically significant (R square 0.846, F 16.541, p 0.027).
CONCLUSION


Ingestion of pesticides remains the most important means of suicides in rural Sri Lanka. The pesticides that were once responsible for most pesticide suicides have now been replaced by carbosulfan and profenofos. Their regulation and replacement in agriculture with less hazardous pesticides will further reduce the incidence of both pesticide and overall suicides in rural Sri Lanka.",2020,Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides.,"['rural Sri Lanka following the 2008-2014 pesticide bans', '337 suicidal deaths', 'Anuradhapura district of Sri Lanka from 2011 to 16']",[],['overall suicide rate'],"[{'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031253', 'cui_str': 'Pesticide'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",,0.0803916,Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Weerasinghe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Konradsen', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Suneth', 'Initials': 'S', 'LastName': 'Agampodi', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Sumith', 'Affiliation': 'Office of the Registrar of Pesticides, Getambe, Peradeniya, Sri Lanka.'}, {'ForeName': 'Shaluka', 'Initials': 'S', 'LastName': 'Jayamanne', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'S M H M K', 'Initials': 'SMHMK', 'LastName': 'Senanayake', 'Affiliation': 'Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Sandamali', 'Initials': 'S', 'LastName': 'Rajapaksha', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. m.eddleston@ed.ac.uk.'}]",BMC public health,['10.1186/s12889-020-08871-7']
2172,32450857,Harnessing health plan enrollee data to boost membership in patient-powered research networks.,"BACKGROUND


Patient-powered research networks (PPRNs) have been employing and exploring different methods to engage patients in research activities specific to their conditions. One way to intensify patient engagement is to partner with payer stakeholders. The objective of this study was to evaluate the effectiveness of two common payer-initiated outreach methods (postal mail versus email) for inviting prospective candidates to participate in their initiatives.
METHODS


This descriptive study linked members of a nationally-representative private insurance network to four disease-specific PPRN registries. Eligible members meeting diagnostic criteria who were not registered in any of the four PPRNs by 02/28/2018 were identified, and randomly assigned to either the mail or email group. They were contacted in two outreach efforts: first on 04/23/2018, and one follow-up on 05/23/2018. New registration rates by outreach method as of 8/31/2018 were determined by relinking. We compared registrants and non-registrants using bivariate analysis.
RESULTS


A total of 14,571 patients were assigned to the mail group, and 14,574 to the email group. Invitations were successfully delivered to 13,834 (94.9%) mail group and 10,205 (70.0%) email group members. A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001. Members who registered had more comorbidities, were more likely to be female, and had marginally greater medical utilization, especially emergency room visits, relative to non-registrants (52.0% vs. 42.5%, p = 0.05).
CONCLUSION


A health plan outreach to invite members to participate in PPRNs was modestly effective. Regular mail outperformed less costly email. Providing more value-add to participants may be a possible way to increase recruitment success.",2020,"A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001.","['members of a nationally-representative private insurance network to four disease-specific PPRN registries', '14,571 patients were assigned to the mail group, and 14,574 to the email group', 'Eligible members meeting diagnostic criteria who were not registered in any of the four PPRNs by 02/28/2018']",['two common payer-initiated outreach methods (postal mail versus email'],['medical utilization'],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",14571.0,0.0395978,"A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA. xchen@healthcore.com.'}, {'ForeName': 'Abiy', 'Initials': 'A', 'LastName': 'Agiro', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA.'}, {'ForeName': 'W Benjamin', 'Initials': 'WB', 'LastName': 'Nowell', 'Affiliation': 'Global Healthy Living Foundation, Upper Nyack, New York, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Loud', 'Affiliation': 'Accelerated Cure Project, Waltham, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBurney', 'Affiliation': 'Accelerated Cure Project, Waltham, MA, USA.'}, {'ForeName': 'Kalen', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Vasculitis Foundation, Kansas City, MO, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sutphen', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bourquardez Clark', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Burroughs', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA.'}]",BMC health services research,['10.1186/s12913-020-05325-z']
2173,32450869,Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies.,"BACKGROUND


The Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4.
METHODS


PINNACLE-1, -2, and -4 were multicenter, double-blind, randomized controlled trials that enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden. Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks. The primary endpoint of the pooled analysis was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) at week 24. Secondary endpoints included COPD exacerbations and clinically important deterioration (CID). Adverse events were also assessed.
RESULTS


The pooled intent-to-treat population included 4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year. At week 24, GFF MDI improved morning pre-dose trough FEV 1  versus GP MDI (least squares mean [LSM] difference [95% confidence interval (CI)]: 59 mL [43, 75]), FF MDI (65 mL [48, 81]), and placebo MDI (146 mL [125, 166]); all p < 0.0001. GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively. In general, exacerbation risk reduction with GFF MDI versus comparators was greater in subgroups of symptomatic patients (CAT ≥15) and those who had an exacerbation history, than in the pooled intent-to-treat population. The risk of CID was also lower with GFF MDI versus GP MDI (23% decrease), FF MDI (17%), and placebo MDI (49%); all p < 0.0001. All treatments were well tolerated, with no unexpected safety signals.
CONCLUSIONS


This pooled analysis of the PINNACLE studies demonstrated that GFF MDI improved lung function and reduced the risk of exacerbations compared with monocomponents and placebo in patients with COPD. Exacerbation reductions with GFF MDI versus comparators were generally greater in patients with higher symptom burden and those with exacerbation history.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01854645, NCT01854658, and NCT02343458. Registered 13 May 2013 (NCT01854645, NCT01854658) and 6 January 2015 (NCT02343458).",2020,"GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively.","['4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year', 'patients with COPD', 'patients with moderate-to-very severe COPD', 'enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden', 'chronic obstructive pulmonary disease (COPD']","['placebo MDI', 'GFF MDI 18/9.6\u2009μg, glycopyrrolate (GP) MDI 18\u2009μg, formoterol fumarate (FF) MDI 9.6\u2009μg, or placebo MDI', 'GFF MDI', 'glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI', 'placebo']","['lung function and reducing exacerbations', 'COPD exacerbations and clinically important deterioration (CID', 'risk of exacerbations', 'Adverse events', 'risk of a moderate/severe exacerbation', 'FF MDI', 'lung function', 'efficacy and safety', 'GFF MDI improved morning pre-dose trough FEV 1  versus GP MDI', 'morning pre-dose trough forced expiratory volume', 'risk of CID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",4983.0,0.642539,"GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively.","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, 525 E 68th St, Room M-522, Box 130, New York, NY, 10065, USA. fjm2003@med.cornell.edu.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Lipworth', 'Affiliation': 'Scottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Kiel, Germany.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Collier', 'Affiliation': 'William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'University at Buffalo, SUNY, Buffalo, NY, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Feldman', 'Affiliation': 'S. Carolina Pharmaceutical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': ""O'Brien"", 'Affiliation': 'formerly of AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}]",Respiratory research,['10.1186/s12931-020-01388-y']
2174,32450875,Transfer of skills for difficult intubation after videolaryngoscopy training: a randomized simulation study.,,2020,,[],['videolaryngoscopy training'],[],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0560831,,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kee', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore. Adrian_cl_kee@nuhs.edu.sg.'}, {'ForeName': 'Reyor', 'Initials': 'R', 'LastName': 'Ko', 'Affiliation': 'Ministry of Health Holdings, Singapore, Singapore.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Capistrano', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Dajac', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Juvel', 'Initials': 'J', 'LastName': 'Taculod', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Kay Choong', 'Initials': 'KC', 'LastName': 'See', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore.'}]","Critical care (London, England)",['10.1186/s13054-020-02982-8']
2175,32450901,Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial.,"BACKGROUND


The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own.
METHODS/DESIGN


The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted.
DISCUSSION


The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
TRIAL REGISTRATION


ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.",2020,"The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
",['Twenty-six providers of health information (groups with up to ten members'],"['training programme', 'intervention (guideline and training programme) with usual care (a publicly available guideline']",['quality of the health information'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0719784,"The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lühnen', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany. Julia.Luehnen@medizin.uni-halle.de.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Haastert', 'Affiliation': 'mediStatistica, Lambertusweg 1b, 58809, Neuenrade, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hinneburg', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kasper', 'Affiliation': 'Faculty of Health Sciences, Department of Health and Caring Sciences, University of Tromsø, Postbox 6050, Langnes, Norway.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}]",Trials,['10.1186/s13063-020-04287-1']
2176,32450904,Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial.,"BACKGROUND


Cochrane, an organization dedicated to the production and dissemination of high-quality evidence on health, endeavors to reach consumers by developing appropriate summary formats of its systematic reviews. However, the optimal type of presentation of evidence to consumers is still unknown.
OBJECTIVE


The aim of this study was to investigate consumer preferences for different summary formats of Cochrane systematic reviews (CSRs), using both qualitative and quantitative approaches.
METHODS


Initially, we conducted three focus groups with medical students (n = 7), doctors (n = 4), and patients (n = 9) in 2017 to explore their health information search habits and preferences for CSR summary formats. Based on those findings, we conducted a randomized trial with medical students at the University of Split School of Medicine, Croatia, and with patients from three Dalmatian family practices to determine whether they prefer CSR blogshots (n = 115) or CSR plain language summaries (PLSs; n = 123).
RESULTS


Participants in the focus groups favored brief and explicit CSR summary formats with fewer numbers. Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2  = 0.04).
CONCLUSION


CSR summaries should be produced in a format that meets the expectations and needs of consumers. Use of blogshots as a summary format could enhance the dissemination of CSRs among patients.
TRIAL REGISTRATION


The trial was registered in ClinicalTrials.gov, NCT03542201. Registered on May 31st 2018.",2020,"Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2  = 0.04).
","['medical students at the University of Split School of Medicine, Croatia, and with patients from three Dalmatian family practices to determine whether they prefer CSR blogshots (n\u2009=\u2009115) or CSR plain language summaries (PLSs; n\u2009=\u2009123', 'groups with medical students (n\u2009=\u20097), doctors (n\u2009=\u20094), and patients (n\u2009=\u20099) in 2017 to explore their health information search habits and preferences for CSR summary formats']",[],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0324355', 'cui_str': 'Dalmatian dog'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1301627', 'cui_str': 'Format'}]",[],[],,0.172296,"Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2  = 0.04).
","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Buljan', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia. ivan.buljan@mefst.hr.'}, {'ForeName': 'Ružica', 'Initials': 'R', 'LastName': 'Tokalić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Roguljić', 'Affiliation': 'Department of Oral Diseases and Periodontology, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Vrdoljak', 'Affiliation': 'Department of Family Medicine, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Milić', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Center for Evidence-based Medicine and Health Care, Catholic University of Croatia, Split, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Marušić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}]",Trials,['10.1186/s13063-020-04360-9']
2177,32450908,Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial.,"BACKGROUND


As an irreversible, intractable disease with vision loss, glaucoma leads to permanent and progressive damage of visual function. Lowering high intraocular pressure (HIOP) is the first choice for treating glaucoma; however, the control of HIOP is not enough to prevent progressive vison loss. Currently, the therapies to treat glaucoma with controlled IOP (GPCI) are unsatisfactory. Chinese medicine is effective for improving visual function in patients with GPCI. Bujing Yishi tablets (BJYSP) have been the standard preparation for treating GPCI in our hospital for decades. However, no rigorous randomized controlled clinical studies have investigated its effects and safety.
METHODS


This study will be a 6-month, multicenter, stratified trial following a prospective, randomized, open-label, blinded endpoint (PROBE) protocol. A total of 216 eligible GPCI patients aged 18-75 years will be stratified according to the early, moderate, and advanced stages of glaucoma. After stratifying, the participants will be randomly assigned to the BJYSP group or control group at a ratio of 1:1. Following randomization, participants in the BJYSP group and control group will receive BJYSP and mecobalamin tablets, respectively, for the same 6-month period. The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales. The primary and secondary outcomes will be measured at baseline and 8, 16, and 24 weeks thereafter. Safety assessments will also be evaluated at baseline and 12 and 24 weeks thereafter.
DISCUSSION


This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of BJYSP as a novel therapeutic strategy for improving visual function in patients with GPCI.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016431. Registered on 1 June 2018.",2020,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","['patients with GPCI', '216 eligible GPCI patients aged 18-75\u2009years will be stratified according to the early, moderate, and advanced stages of glaucoma']","['BJYSP', 'Lowering high intraocular pressure (HIOP', 'Bujing Yishi tablets (BJYSP', 'BJYSP and mecobalamin tablets', 'Bujing Yishi tablet', 'Chinese medicine']","['visual function', 'best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",216.0,0.291797,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","[{'ForeName': 'Hongji', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China. carol_hongji@126.com.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. jeannelxiang@cdutcm.edu.cn.'}, {'ForeName': 'Zongduan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'National Drug Clinical Trial Agency, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Mianyang Hospital of Traditional Chinese Medicine, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Chengdu PiDu District, Chengdu, 611733, Sichuan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510275, Guangdong, China.'}, {'ForeName': 'Linru', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China.'}]",Trials,['10.1186/s13063-020-04249-7']
2178,32450914,"Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia.","BACKGROUND


The AWED (Applying Wolbachia to Eliminate Dengue) trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Yogyakarta, Indonesia, with the aim of measuring the efficacy of Wolbachia-infected Aedes aegypti deployments in reducing dengue incidence in an endemic setting. Enrolment began in January 2018 and is ongoing. The original study protocol was published in April 2018. Here, we describe amendments that have been made to the study protocol since commencement of the trial.
METHODS


The key protocol amendments are (1) a revised study duration with planned end of participant enrolment in August 2020, (2) the addition of new secondary objectives (i) to estimate serotype-specific efficacy of the Wolbachia intervention and (ii) to compare Ae. aegypti abundance in intervention versus untreated clusters, (3) an additional exposure classification for the per-protocol analysis where the Wolbachia exposure index is calculated using only the cluster-level Wolbachia prevalence in the participant's cluster of residence, (4) power re-estimation using a multinomial sampling method that better accounts for randomness in sampling, and (5) the addition of two trial stopping rules to address the potential for persistently low rates of virologically confirmed dengue case enrolment and Wolbachia contamination into untreated clusters. Additional minor changes to the protocol are also described.
DISCUSSION


The findings from this study will provide the first experimental evidence for the efficacy of Wolbachia in reducing dengue incidence. Enrolment in the trial will conclude this year (2020) and results will be reported shortly thereafter.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier: NCT03055585. Registered on 14 February 2017. Last updated 22 March 2020.",2020,"BACKGROUND


The AWED (Applying Wolbachia to Eliminate Dengue)",[],"['Wolbachia intervention and (ii) to compare Ae', 'Wolbachia-infected Aedes aegypti deployments']",['aegypti abundance'],[],"[{'cui': 'C0752001', 'cui_str': 'Wolbachia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}]",[],,0.212877,"BACKGROUND


The AWED (Applying Wolbachia to Eliminate Dengue)","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Anders', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia. katie.anders@worldmosquito.org.'}, {'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Indriani', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Riris Andono', 'Initials': 'RA', 'LastName': 'Ahmad', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Warsito', 'Initials': 'W', 'LastName': 'Tantowijoyo', 'Affiliation': 'World Mosquito Program, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Eggi', 'Initials': 'E', 'LastName': 'Arguni', 'Affiliation': 'Department of Pediatrics and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Bekti', 'Initials': 'B', 'LastName': 'Andari', 'Affiliation': 'Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Centre for Statistical Methodology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Dufault', 'Affiliation': 'School of Public Health, University of California, 2121 Berkeley Way, Berkeley, 94720-7360, CA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ryan', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Tanamas', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Rancès', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': ""O'Neill"", 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Cameron P', 'Initials': 'CP', 'LastName': 'Simmons', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}]",Trials,['10.1186/s13063-020-04367-2']
2179,32450915,"The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial.",,2020,,"['non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline']","['hydroxychloroquine and azithromycin', 'care (SOC) alone, SOC plus hydroxychloroquine monotherapy']",[],"[{'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.338873,,"[{'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Feeney', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland. deborah.wallace@ucd.ie.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Cotter', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Willard', 'Initials': 'W', 'LastName': 'Tinago', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keane', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Alvarez Barco', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallon', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}]",Trials,['10.1186/s13063-020-04407-x']
2180,32450917,"Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation.","BACKGROUND


Delayed graft function, the requirement for dialysis due to poor kidney function post-transplant, is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes and higher costs. Intravenous fluids given during and after transplantation may affect the risk of poor kidney function after transplant. The most commonly used fluid, isotonic sodium chloride (0.9% saline), contains a high chloride concentration, which may be associated with acute kidney injury, and could increase the risk of delayed graft function. Whether using a balanced, low-chloride fluid instead of 0.9% saline is safe and improves kidney function after deceased donor kidney transplantation is unknown.
METHODS


BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-center, double-blind, randomized controlled trial. The primary objective is to compare the effect of intravenous Plasma-Lyte 148 (Plasmalyte), a balanced, low-chloride solution, with the effect of 0.9% saline on the incidence of delayed graft function in deceased donor kidney transplant recipients. From January 2018 onwards, 800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand. Participants are randomized 1:1 to either intravenous Plasmalyte or 0.9% saline peri-operatively and until 48 h post-transplant, or until fluid is no longer required; whichever comes first. Follow up is for 1 year. The primary outcome is the incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant. Secondary outcomes include early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness. Participants are enrolled, randomized, and followed up using the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry.
DISCUSSION


If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12617000358347. Registered on 8 March 2017. ClinicalTrials.gov: NCT03829488. Registered on 4 February 2019.",2020,"If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
","['deceased donor\xa0kidney transplant recipients', '800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand', 'deceased donor kidney transplantation', 'Australian New Zealand Clinical Trials Registry']","['intravenous Plasmalyte or 0.9% saline peri-operatively and until 48\u2009h post-transplant', 'isotonic sodium chloride (0.9% saline', 'intravenous Plasma-Lyte 148 (Plasmalyte', 'intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline']","['early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness', 'delayed graft function', 'incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant', 'kidney function', 'risk of poor kidney function']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",800.0,0.626492,"If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Collins', 'Affiliation': 'Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand. michael.collins@adhb.govt.nz.'}, {'ForeName': 'Magid A', 'Initials': 'MA', 'LastName': 'Fahim', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Dansie', 'Affiliation': 'Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Clayton', 'Affiliation': 'Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Rachael C', 'Initials': 'RC', 'LastName': 'McConnochie', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Mount', 'Affiliation': 'Department of Nephrology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Varghese', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liza A', 'Initials': 'LA', 'LastName': 'Vergara', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chadban', 'Affiliation': 'Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04359-2']
2181,32450921,Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.,"BACKGROUND


Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients' prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients.
METHODS


This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥ 3 at 60 Gy and both grade ≥ 2 and grade ≥ 3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rates of grade ≥ 2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%.
DISCUSSION


If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients with head-and-neck cancer during radiotherapy.
TRIAL REGISTRATION


clinicaltrials.gov (NCT04110977). Registered on September 27, 2019. First patient is planned to be included in December 2019.",2020,"This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer.","['head-and-neck cancer', 'patients with head-and-neck cancer during radiotherapy', 'for locally advanced head- and-neck cancer', 'and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis']","['standard care alone (Arm B) with respect to grade\u2009≥\u20092 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy', 'mobile application reminding head', 'radiotherapy', 'Radiotherapy']","['quality of life and pain', 'Severe toxicities', 'radiation dermatitis and oral mucositis', 'skin toxicity', 'dermatitis and oral mucositis rates']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}]",,0.117227,"This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rades', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany. rades.dirk@gmx.net.'}, {'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Narvaez', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Doemer', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssen', 'Affiliation': 'Medical Practice for Radiotherapy and Radiation Oncology, Hanover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Olbrich', 'Affiliation': 'Centre for Clinical Trials Lübeck, Lübeck, Germany.'}, {'ForeName': 'Soeren', 'Initials': 'S', 'LastName': 'Tvilsted', 'Affiliation': 'Research Projects and Clinical Optimization, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Conde-Moreno', 'Affiliation': 'Department of Radiation Oncology, Hospital Universitario y Politecnico La Fe, Valencia, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Cacicedo', 'Affiliation': 'Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute, Barakaldo, Vizcaya, Spain.'}]",Trials,['10.1186/s13063-020-04307-0']
2182,32450928,A randomized clinical trial to assess the efficacy of trial-based cognitive therapy (TBCT) compared to prolonged exposure for post-traumatic stress disorder: preliminary findings.,,2020,,['post-traumatic stress disorder'],['trial-based cognitive therapy (TBCT'],[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0479708,,"[{'ForeName': 'Érica Panzani', 'Initials': 'ÉP', 'LastName': 'Duran', 'Affiliation': ''}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Corchs', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianna', 'Affiliation': ''}, {'ForeName': 'Álvaro Cabral', 'Initials': 'ÁC', 'LastName': 'Araújo', 'Affiliation': ''}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Del Real', 'Affiliation': ''}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'De Vitto Francez', 'Affiliation': ''}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Godói', 'Affiliation': ''}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Silveira', 'Affiliation': ''}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Matsumoto', 'Affiliation': ''}, {'ForeName': 'Cristiane Maluhy', 'Initials': 'CM', 'LastName': 'Gebara', 'Affiliation': ''}, {'ForeName': 'Tito Paes', 'Initials': 'TP', 'LastName': 'de Barros Neto', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Chilvarquer', 'Affiliation': ''}, {'ForeName': 'Luciana Lima', 'Initials': 'LL', 'LastName': 'de Siqueira', 'Affiliation': ''}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Bernik', 'Affiliation': ''}, {'ForeName': 'Francisco Lotufo', 'Initials': 'FL', 'LastName': 'Neto', 'Affiliation': ''}]",CNS spectrums,['10.1017/S1092852920001455']
2183,32450939,Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan.,"BACKGROUND


Social anxiety is common among adolescents in Pakistan and is associated with low self-esteem. Among the recommended treatments, cognitive behavioural therapy (CBT) is effective, and self-help approaches are encouraged.
AIM


To determine the effectiveness of culturally adapted CBT-based guided self-help (CACBT-GSH) intervention, using a manual 'Khushi aur Khatoon', for treating social anxiety when added to treatment as usual (TAU) compared with TAU only.
METHOD


A total of 76 adolescents with social anxiety aged 13-16 years from six schools in Multan, Pakistan were recruited into this randomized controlled trial. Participants were divided into intervention and control groups in a 1:1 ratio. Social anxiety, self-esteem and fear of negative evaluation were assessed through the Liebowtiz Social Anxiety Scale for children and adolescents, the Rosenberg Self-Esteem Scale and the Brief Fear of Negative Evaluation, respectively, at baseline and at the end of the study. Guided self-help using culturally adapted CBT (CACBT)-based self-help manual (eight sessions, one session per week) was provided to the intervention group. The effect of the CACBT-GSH intervention was analysed with ANCOVA.
RESULTS


There was a statistically significant difference between the intervention and the control groups in favour of intervention. Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
CONCLUSION


The study demonstrated the effectiveness of CACBT-based guided self-help intervention in treating social anxiety and addressing the symptoms associated with it.",2020,"Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
","['76 adolescents with social anxiety aged 13-16 years from six schools in Multan, Pakistan', 'adolescents']","['CACBT-GSH intervention', 'culturally adapted CBT-based guided self-help (CACBT-GSH) intervention', 'CACBT-based guided self-help intervention', 'culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention', 'cognitive behavioural therapy (CBT', 'Guided self-help using culturally adapted CBT (CACBT)-based self-help manual']","['social anxiety and enhance self-esteem', 'Social anxiety, self-esteem and fear of negative evaluation', 'Liebowtiz Social Anxiety Scale', 'reduced symptoms of social anxiety', 'fear of negative evaluation', 'enhanced self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",76.0,0.0186652,"Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
","[{'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': 'Department of Professional Psychology, Bahria University, Islamabad, Pakistan.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Applied Psychology, Bahauddin Zakariya UniversityMultan, Pakistan.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'University of Toronto and Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Irfan', 'Affiliation': 'Department of Mental Health, Psychiatry & Behavioural Sciences, Peshawar Medical College, Riphah International University, Islamabad, Pakistan.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000284']
2184,32450979,Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study.,"BACKGROUND


Visual inspection (VIS) with radiographic examination (RAD) is the recommended diagnostic strategy for detecting caries in children; however, this recommendation is based on accuracy studies. The authors conducted a clinical trial to compare the detection and subsequent treatment of carious lesions in primary molars performed with VIS alone and with RAD.
METHODS


Children (3-6 years old) were randomly assigned to 2 groups according to the diagnostic strategy used for caries detection on primary molars: VIS or RAD. Participants were diagnosed and treated according to the management plan related to the allocated group. The primary outcome was the number of new operative interventions during the 2-year follow-up period. Other secondary outcomes were also compared. Comparisons were performed with Mann-Whitney test using an intention-to-treat approach.
RESULTS


Of the 252 children included and randomized, 216 were followed-up after 2 years (14.3% attrition rate). There was no difference between the groups for the primary outcome (P = .476). For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group. In addition, the RAD group had a higher number of false-positive results than the VIS group (P < .001).
CONCLUSIONS


Simultaneous use of VIS and RAD for caries diagnosis in primary molars of children who seek dental treatment does not provide additional benefits compared with VIS alone.
PRACTICAL IMPLICATIONS


Dentists should perform VIS only, not RAD, for detecting carious lesions in preschool-aged children. ClinicalTrials.gov: NCT02078453.",2020,"For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group.","['caries in children', 'Children (3-6 years old', 'children through a 2-year randomized clinical trial', '252 children', 'preschool-aged children']","['diagnostic strategy used for caries detection on primary molars: VIS or RAD', 'VIS and RAD', 'Visual inspection (VIS) with radiographic examination (RAD', 'VIS alone and with RAD', 'visual inspection and radiographs']","['restoration replacements', 'number of false-positive results', 'number of new operative interventions']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",252.0,0.157572,"For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group.","[{'ForeName': 'Laura R A', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': ''}, {'ForeName': 'Tatiane F', 'Initials': 'TF', 'LastName': 'Novaes', 'Affiliation': ''}, {'ForeName': 'Juan S', 'Initials': 'JS', 'LastName': 'Lara', 'Affiliation': ''}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Gimenez', 'Affiliation': ''}, {'ForeName': 'Bruna L P', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': ''}, {'ForeName': 'Lucila B', 'Initials': 'LB', 'LastName': 'Camargo', 'Affiliation': ''}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Michel-Crosato', 'Affiliation': ''}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'Pannuti', 'Affiliation': ''}, {'ForeName': 'Daniela P', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': ''}, {'ForeName': 'Mariana M', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': ''}, {'ForeName': 'Fausto M', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': ''}]",Journal of the American Dental Association (1939),['10.1016/j.adaj.2020.02.008']
2185,32451005,A comparison of Gordon's functional health patterns model and standard nursing care in symptomatic heart failure patients: A randomized controlled trial.,"BACKGROUND


Heart failure (HF) is associated with poor quality of life and increased morbidity and mortality.
AIM


This study aimed to investigate effect of application of Gordon's functional health pattern (FHP) model in nursing care of symptomatic HF patients on quality of life, morbidity and mortality in the post-discharge 30-day.
METHODS


This is a prospective randomized controlled study conducted in a single center. Experimental group received nursing care planned in accordance with Gordon's FHP model. 60 control and 60 experimental HF patients were included in the study. In the control group nursing care was given according to the standard protocol of the hospital whereas in the experimental group nursing care was given in accordance with Gordon's FHP model. Patients in both groups were followed up after discharge at 30th day.
RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001). Seven patients (11.7%) in the experimental group and 17 patients (28.3%) in the control group were readmitted in the post discharge 30-day (p = 0.02). Kaplan-Meier survival curve analysis revealed significant difference in 30-day event free survival rates between groups (log-rank p = 0.31).
CONCLUSION


Application of Gordon's FHP model in the nursing care of HF patients was associated with significantly improved quality of life, and reduced hospital readmission rates at 30th day. This was the only independent predictor of 30-day event free survival.",2020,"RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001).","['symptomatic heart failure patients', '60 control and 60 experimental HF patients were included in the study', 'nursing care of symptomatic HF patients']","[""nursing care planned in accordance with Gordon's FHP model"", ""Gordon's functional health patterns model and standard nursing care"", ""Gordon's functional health pattern (FHP) model""]","['quality of life, and reduced hospital readmission rates', '30-day event free survival rates', 'Mean Minnesota Living with Heart Failure Questionnaire score', 'post discharge 30-day', 'quality of life, morbidity and mortality']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0028683', 'cui_str': 'Plans, Nursing Care'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0612579,"RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001).","[{'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Türen', 'Affiliation': 'T.C.\xa0Istanbul Kültür University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey. Electronic address: sevdamercanhm@hotmail.com.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Enç', 'Affiliation': 'Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151247']
2186,32451010,"Effects of auricular acupressure on the quality of sleep and anxiety in patients undergoing cardiac surgery: A single-blind, randomized controlled trial.","AIM


This study aimed to evaluate the effects of auricular acupressure (AA), a non-invasive type of reflexotherapy, on sleep quality and anxiety in patients after cardiac surgery.
BACKGROUND


Sleep disturbances and anxiety hinder the recovery of patients after cardiac surgery; thus, appropriate and adequate nursing interventions must be pursued. AA is a complementary therapy suitable for patients with limited pharmacological therapy options.
METHOD


A single-blind, randomized controlled trial with a pretest-posttest control group design was applied. The study consisted of 42 patients, comprising an experimental group (n = 21) and a control group (n = 21). AA was applied for six days per trial for a total of 2 trials, while sleep (sleep score, sleep satisfaction) and anxiety (state, trait) were measured at three time points (pre-op, 7 days post-op, and 14 days post-op).
RESULTS


The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group. No significant difference was found in anxiety state/trait between the two groups.
CONCLUSIONS


We conclude that AA is a safe, effective, noninvasive, and low-risk nursing intervention that can improve sleep quality in patients after cardiac surgery.",2020,The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group.,"['patients after cardiac surgery', 'patients undergoing cardiac surgery', 'patients with limited pharmacological therapy options', '42 patients, comprising an experimental group (n\xa0=\xa021) and a control group (n\xa0=\xa021']","['reflexotherapy', 'auricular acupressure (AA', 'auricular acupressure']","['sleep and sleep satisfaction scores', 'sleep (sleep score, sleep satisfaction) and anxiety (state, trait', 'sleep quality and anxiety', 'quality of sleep and anxiety', 'sleep quality', 'anxiety state/trait']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034946', 'cui_str': 'Reflex Therapy'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",42.0,0.0754569,The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group.,"[{'ForeName': 'Yun Yi', 'Initials': 'YY', 'LastName': 'Bang', 'Affiliation': 'Department of Nursing, KyungBok University, Gyeonggi-do, Republic of Korea. Electronic address: yybang@kbu.ac.kr.'}, {'ForeName': 'Hyojung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, Republic of Korea. Electronic address: hyojungp@ewha.ac.kr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151269']
2187,32451125,Perioperative probiotic treatment decreased the incidence of postoperative cognitive impairment in elderly patients following non-cardiac surgery: A randomised double-blind and placebo-controlled trial.,"BACKGROUND


Given that population aging is a global health challenge, the high prevalence of postoperative neurocognitive impairment in elderly patients necessitates the development of novel simple and effective prevention methods.
OBJECTIVE


To evaluate the effects of perioperative application of oral probiotic as a prophylaxis for cognitive impairment in elderly patients following non-cardiac surgery.
METHODS


This randomised double-blind and placebo-controlled trial included 120 elderly patients (in a modified intention-to-treat analysis) scheduled for elective orthopaedic or colorectal surgery. Patients were assigned to receive either probiotics or a placebo from hospital admission until discharge. The primary endpoint was the incidence of postoperative cognitive impairment, defined as a decrease of ≥3 points in the Mini-Mental State Examination (MMSE) scores from admission baseline to the 7th day post-surgery. Secondary endpoints included changes in plasma interleukin-6 (IL-6) and cortisol, postoperative pain intensity, postoperative sleep quality, gastrointestinal function recovery, and faecal microbiota composition.
RESULTS


The incidence of postoperative cognitive impairment in the probiotic group was significantly lower than in the control group (3 of 59 patients [5.1%] vs. 10 of 61 patients [16.4%], P = 0.046). In addition, compared to pre-surgery, the levels of plasma IL-6 and cortisol in the probiotic group decreased more than in the control group 5-7 days after surgery (IL-6: -117.90 ± 49.15 vs. -14.93 ± 15.21, P = 0.044; cortisol: -158.70 ± 53.52 vs. 40.98 ± 72.48, P = 0.010). Relative abundance at the genus level in the faeces of the probiotic group also changed more than in that of the control group during the perioperative period. In contrast, postoperative pain intensity, sleep quality, and gastrointestinal function recovery did not differ significantly between the two groups.
CONCLUSION


Perioperative application of oral probiotic prevents postoperative cognitive impairment in elderly patients following non-cardiac surgery, possibly via the limitation of peripheral inflammation and the stress response.",2020,"In contrast, postoperative pain intensity, sleep quality, and gastrointestinal function recovery did not differ significantly between the two groups.
","['elderly patients', '120 elderly patients (in a modified intention-to-treat analysis) scheduled for elective orthopaedic or colorectal surgery', 'elderly patients following non-cardiac surgery']","['probiotics or a placebo', 'Perioperative probiotic treatment', 'oral probiotic', 'placebo']","['levels of plasma IL-6 and cortisol', 'postoperative pain intensity, sleep quality, and gastrointestinal function recovery', 'incidence of postoperative cognitive impairment', 'changes in plasma interleukin-6 (IL-6) and cortisol, postoperative pain intensity, postoperative sleep quality, gastrointestinal function recovery, and faecal microbiota composition', 'incidence of postoperative cognitive impairment, defined as a decrease of ≥3 points in the Mini-Mental State Examination (MMSE) scores', 'postoperative cognitive impairment']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.420236,"In contrast, postoperative pain intensity, sleep quality, and gastrointestinal function recovery did not differ significantly between the two groups.
","[{'ForeName': 'Pingzhu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China; Hunan Province Key Laboratory of Brain Homeostasis, Third Xiangya Hospital, Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Xinlin', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Le', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Zhongcong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Geriatric Anesthesia Research Unit, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Charlestown, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China. Electronic address: ouyangwen133@vip.sina.com.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, PR China; Hunan Province Key Laboratory of Brain Homeostasis, Third Xiangya Hospital, Central South University, Changsha, Hunan, PR China; Center for Experimental Medicine, Third Xiangya Hospital, Central South University, Changsha, Hunan, PR China. Electronic address: jianbintong@csu.edu.cn.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.001']
2188,32451130,Comparison of methemoglobin levels in food protein-induced enterocolitis syndrome and other gastrointestinal diseases in neonates.,"INTRODUCTION AND OBJECTIVES


Methemoglobinemia has been reported to be associated with severe food protein-induced enterocolitis syndrome (FPIES). However, no reports have evaluated methemoglobin (MHb) levels in FPIES without symptomatic methemoglobinemia or the usefulness of MHb measurement for the diagnostic prediction of FPIES. To evaluate the MHb levels of patients with neonatal-onset FPIES and determine whether MHb levels are higher in FPIES than in other gastrointestinal diseases.
PATIENTS AND METHODS


Eleven neonates with severe acute FPIES (FPIES group) and 139 neonates with other gastrointestinal diseases (non-FPIES group) were included in this study. Patient characteristics, symptoms, and venous blood test values (MHb, pH, HCO 3 - , and C-reactive protein) were evaluated.
RESULTS


The median age at onset was 16 days vs. 1 day; males comprised 64% vs. 46%, the median gestational age was 38 weeks vs. 38 weeks, the median birth weight was 2710g vs. 2880g, and the median hospitalization duration was 31 days vs. 6 days for the FPIES vs. non-FPIES groups, respectively. MHb (%) was higher in the FPIES group than in the non-FPIES group [median (range), 1.1 (0.6-10.9) and 0.6 (0.3-1.2), respectively, p<0.001]. There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05). In the receiver operating characteristic analysis for FPIES diagnosis based on MHb (%), the area under the curve was 0.885, specificity was 97.1%, and sensitivity was 72.7% at a MHb cutoff of 1.0.
CONCLUSION


High MHb levels may help diagnose severe acute FPIES in neonates, but careful evaluation is needed.",2020,"There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05).","['food protein-induced enterocolitis syndrome and other gastrointestinal diseases in neonates', 'patients with neonatal-onset FPIES', 'Eleven neonates with severe acute FPIES (FPIES group) and 139 neonates with other gastrointestinal diseases (non-FPIES group']",['Methemoglobinemia'],"['pH, HCO 3 - , and C-reactive protein (p>0.05', 'median birth weight', 'sensitivity', 'methemoglobin (MHb) levels', 'median hospitalization duration', 'Patient characteristics, symptoms, and venous blood test values (MHb, pH, HCO 3 - , and C-reactive protein', 'MHb levels']","[{'cui': 'C4268599', 'cui_str': 'Food-protein induced enterocolitis syndrome'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0025637', 'cui_str': 'Methemoglobinemia'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0025635', 'cui_str': 'Methemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",11.0,0.147106,"There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05).","[{'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Makita', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan. Electronic address: r0947em@jichi.ac.jp.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan; Department of Pediatrics, Saitama Red Cross Hospital, Saitama 330-8553, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Kae', 'Initials': 'K', 'LastName': 'Itabashi', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawano', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Matsuura', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Maruyama', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ichihashi', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2020.01.007']
2189,32451161,TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.,"BACKGROUND


This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS).
OBJECTIVES


TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP.
METHODS


TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test.
DISCUSSION


This paper will provide a detailed description of the planned analyses for the TOPS trial.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).",2020,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.",['people who have recently recovered from an episode of LBP'],"['exercise and education classes', 'TOPS', 'exercise and education', 'physical therapist-led exercise and education program for 12 weeks or minimal intervention']","['survival curves', 'recurrence of low back pain (LBP', 'recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day', 'days to recurrence of an episode of LBP', 'Hazard ratios (HRs) and median survival times', 'number of adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.294755,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.","[{'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia. Electronic address: giovanni.ferreira@sydney.edu.au.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Matthew Leigh', 'Initials': 'ML', 'LastName': 'Stevens', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Wisbey-Roth', 'Affiliation': 'Bounce Back Active Rehabilitation Systems, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.05.001']
2190,32451179,"Re: Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma (the POUT Trial): A Phase 3, Open-label, Randomised Controlled Trial.",,2020,,['Upper Tract Urothelial Carcinoma (the POUT Trial'],['Re: Adjuvant Chemotherapy'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",[],,0.179276,,"[{'ForeName': 'Teele', 'Initials': 'T', 'LastName': 'Kuusk', 'Affiliation': 'Specialist Centre for Kidney Cancer, UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Specialist Centre for Kidney Cancer, UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK. Electronic address: a.bex@ucl.ac.uk.'}]",European urology,['10.1016/j.eururo.2020.04.021']
2191,32451203,Determination of the Effectiveness of Informing With the Guidance of an Education Booklet in Patients Undergoing Colonoscopy-A Randomized Controlled Trial.,"PURPOSE


The aim of this study was to determine the effect of precolonoscopy information with the guidance of an education booklet on anxiety and bowel preparation adequacy in patients undergoing colonoscopy.
DESIGN


A randomized controlled study.
METHODS


The education group was informed face to face by the researcher with the guidance of the colonoscopy education booklet and provided the education booklet. The control group received usual care.
FINDINGS


The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group. In the education group, the bowel preparation adequacy was determined to be higher compared with the control group.
CONCLUSIONS


Informing patients with the guidance of the education booklet before the colonoscopy decreased patients' state and trait anxiety levels and increased their bowel preparation adequacy.",2020,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"['Patients Undergoing Colonoscopy', 'patients undergoing colonoscopy']","['precolonoscopy', 'usual care', 'education booklet', 'Education Booklet', 'colonoscopy education booklet and provided the education booklet']","['bowel preparation adequacy', 'anxiety and bowel preparation adequacy', 'mean state and trait anxiety scores', ""patients' state and trait anxiety levels""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.0400547,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"[{'ForeName': 'Zeynep Kızılcık', 'Initials': 'ZK', 'LastName': 'Özkan', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey. Electronic address: zeynepkizilcik26@hotmail.com.'}, {'ForeName': 'Ümmü Yıldız', 'Initials': 'ÜY', 'LastName': 'Fındık', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.009']
2192,32451212,"Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy, immunogenicity and safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) against rotavirus gastroenteritis (RVGE).
METHODS


Healthy children aged 6-13 weeks were enrolled and randomized (1:1) to either 3 oral doses of LLR3 or placebo according to a 0, 1, 2 month schedule. The objectives were to evaluate vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes contained in the vaccine and not contained in the vaccine after the third dose. Immunogenicity was also assayed in a subgroup. All adverse events (AEs) were collected from 30 min after each dose for immediate reaction, even to the entire study period, including the serious AEs (SAEs) and intussusception.
RESULTS


VE against RVGE of any-severity, sRVGE and inpatient caused by any serotype was 56.6% (95% CI: 50.7, 61.8), 70.3% (95% CI: 60.6, 77.6) and 74.0% (95% CI: 57.5, 84.1) respectively. VE against RVGE of any-severity, sRVGE caused by serotypes not contained in vaccine were 54.2% (95% CI: 47.5, 60.1) and 70.4% (95% CI: 60.4, 77.9). The rate of seroconversion and four-fold increase of rotavirus serotype G2-, G3-, and G4-specific IgA is 60.8%, 58.0%, and 60.6% in vaccine group, which was higher than 21.35%, 22.7%, and 23.1% in placebo group (p < 0.0001 for G2, G3, G4), as well as the Geometric Mean Titer (GMT). Through the entire trial, 65.91% and 67.79% of participants reported at least one AE, and 0.02% and 0.02% reported SAEs in the vaccine and placebo groups, respectively. Two intussusception cases were reported both in vaccine and placebo group.
CONCLUSIONS


In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.",2020,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","['healthy Chinese infants', 'Healthy children aged 6-13\xa0weeks']","['trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'LLR3 or placebo', 'placebo']","['efficacy, immunogenicity and safety', 'vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes', 'rotavirus serotype G2-, G3-, and G4-specific IgA', 'rate of seroconversion', 'Geometric Mean Titer (GMT', 'Efficacy, immunogenicity and safety', 'immunogenicity and safety', 'Immunogenicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0343363', 'cui_str': 'Viral gastroenteritis due to Rotavirus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.734975,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lanzhou Institute of Biological Products Co Ltd, Lanzhou,730046, China.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Qingchuan', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Bianli', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China. Electronic address: liuyan418@nifdc.org.cn.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China. Electronic address: 13691354049@163.com.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Division of Enteric Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China.'}]",Vaccine,['10.1016/j.vaccine.2020.04.038']
2193,32451220,Effectiveness of a communication skills training program for medical students to identify patients communicative clues.,"OBJECTIVE


This study explores whether an Experiential Training Programme (ETP) in communication skills (CS) improves students' ability to identify patients clues compared to those who follow a non-experiential training throughout their medical studies.
METHOD


Intervention Group (IG): 85 4th-year medical students who received the ETP and Control Group (CG): 67 recently graduated students who did not receive it. Their immediate (written) response was requested to three expressions offered by patients containing communicative clues. The answers were grouped into 2 categories: Clue recognised and response patient-centred and the opposite. Three researchers analysed the answers.
RESULTS


Responses 366 (65 from the CG and 77 from the IG): 280 did not recognise clues: 131 (62%) in IG and 149 (96%) in CG and 86 recognised them: 80 (37.9%) in IG and 6 (3.9%) in CG (p = 0.000). Some clues were more elusive than others (p = 0,003).
CONCLUSIONS


The students who received the ETP in CS showed greater ability to explore patients perspective taking advantage of different types of communicative clues than those who did not receive it in a non-relational context.
PRACTICE IMPLICATIONS


Further research is needed to assess whether this ability is maintained in simulated or real clinical situations.",2020,"Some clues were more elusive than others (p = 0,003).
","['Intervention Group (IG): 85 4th-year medical students who received the', 'medical students to identify patients communicative clues']","['Experiential Training Programme (ETP) in communication skills (CS', 'ETP and Control Group (CG): 67 recently graduated students who did not receive it', 'communication skills training program', 'ETP in CS']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0212889,"Some clues were more elusive than others (p = 0,003).
","[{'ForeName': 'Roger Ruiz', 'Initials': 'RR', 'LastName': 'Moral', 'Affiliation': 'School of Medicine, Universidad Francisco de Vitoria, Madrid, Spain; Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, University, Córdoba, Spain. Electronic address: r.ruiz.prof@ufv.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrade-Rosa', 'Affiliation': 'Department of Primary Care, Los Castillos Health Centre, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Juan D Molina', 'Initials': 'JDM', 'LastName': 'Martín', 'Affiliation': 'Department of Psychiatry, Villaverde Mental Health Centre, Hospital 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Emilio Cervera', 'Initials': 'EC', 'LastName': 'Barba', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}, {'ForeName': 'Luis Pérula', 'Initials': 'LP', 'LastName': 'de Torres', 'Affiliation': 'Department of Primary Care Córdoba, Instituto Maimónides De Investigación Biomédica De Córdoba (IMIBIC), Córdoba University, Córdoba, Spain.'}, {'ForeName': 'Diana Monge', 'Initials': 'DM', 'LastName': 'Martín', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}]",Patient education and counseling,['10.1016/j.pec.2020.05.018']
2194,32451241,Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.,"BACKGROUND


Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial.
METHODS


Patients with VLUs measuring 1.5 to 50 cm 2  with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group.
RESULTS


There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
CONCLUSIONS


In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.",2020,"In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
","['Patients with VLUs measuring 1.5 to 50\xa0cm 2  with duration of 1 to 24\xa0months', 'chronic venous leg ulcers', '42 patients who were able to tolerate treatment for the 16-week study period (per protocol group']","['multilayered bandage (MLB) compression systems', 'novel dual-mode ambulatory compression device', 'MLB', 'pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB', 'ambulatory pneumatic compression device', 'ACT']","['percentage area size reduction', 'skin or wound problems', 'percentage of wounds that healed', 'VLU percentage area reduction', 'rates of wound healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",56.0,0.0704574,"In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Marston', 'Affiliation': 'Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: william_marston@med.unc.edu.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kirsner', 'Affiliation': 'Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Fla.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Tallis', 'Affiliation': 'Associated Foot & Ankle Specialists, LLC, Phoenix, Ariz.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Hanft', 'Affiliation': 'The Foot & Ankle Institute, South Miami, Fla.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Walters', 'Affiliation': 'Arizona Regional Medical Research LLC, Tucson, Ariz.'}, {'ForeName': 'Alik', 'Initials': 'A', 'LastName': 'Farber', 'Affiliation': 'Departments of Surgery and Radiology, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.03.004']
2195,32451267,In vitro evaluation of shear bond strength of orthodontic metal brackets to aged composite using a self-adhesive composite: Effect of surface conditioning and different bonding agents.,"OBJECTIVES


Bracket bonding to composite surfaces is increasing. This study sought to assess the effect of different adhesives (acid etchant+Transbond XT™, acid etchant+Vertise Flow™, Vertise Flow™) with different surface treatments (no preparation, bur, sandblasting, Er:YAG laser) on shear bond strength (SBS) of metal brackets to aged composite.
MATERIALS AND METHODS


In this in vitro, experimental study, Filtek™ Z250 composite discs were fabricated (10×4mm). After thermocycling (10,000 cycles between 5-55°C), the samples were randomly divided into three groups (n=48) based on the type of adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™. Samples in each group were randomly divided into four subgroups (n=12) based on the surface treatment including no-treatment, diamond bur, sandblasting and Er:YAG laser. Samples in each group were randomly divided into three subgroups (n=12) based on the type of adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™. After bracket bonding to composite discs, the samples underwent thermocycling (5000 cycles between 5-55°C), and their SBS was measured in a universal testing machine. The samples were then inspected under a stereomicroscope at x10 magnification to determine their mode of failure and adhesive remnant index (ARI).
RESULTS


No significant difference was noted in SBS between adhesives in no-preparation and laser groups (P>0.05). In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching. The SBS provided by acid etchant+Transbond XT™ was significantly higher than that of the other two adhesives (P<0.05). The SBS of sandblasted samples was significantly higher compared with other surface treatments in all adhesive subgroups (P<0.05).
CONCLUSION


Bracket bonding to aged composite using Vertise Flow™ with or without surface treatment can serve as an alternative to the conventional orthodontic adhesives.",2020,"In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching.","['orthodontic metal brackets to aged composite using a self-adhesive composite', 'In this in vitro, experimental study, Filtek™ Z250 composite discs were fabricated (10×4mm']","['adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™', 'surface treatment including no-treatment, diamond bur, sandblasting and Er:YAG laser', 'adhesives (acid etchant+Transbond XT™, acid etchant+Vertise Flow™, Vertise Flow™) with different surface treatments (no preparation, bur, sandblasting, Er:YAG laser']","['SBS of sandblasted samples', 'shear bond strength (SBS', 'SBS']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C3659065', 'cui_str': 'vertise flow'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0174207,"In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Restorative Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golnoosh', 'Initials': 'G', 'LastName': 'Alimohammadi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh Hosseinzadeh', 'Initials': 'TH', 'LastName': 'Nik', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Etemadi', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Periodontics, Faculty of Dentistry, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Behrad', 'Initials': 'B', 'LastName': 'Tanbakuchi', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: behrad.tanbakuchi@yahoo.com.'}]",International orthodontics,['10.1016/j.ortho.2020.04.005']
2196,32451288,Efficacy and adherence of sublingual immunotherapy in patients aged 60 to 75 years old with house dust mite-induced allergic rhinitis.,"PURPOSE


This study aimed to evaluate the efficacy and adherence of sublingual immunotherapy (SLIT) for house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60 years old.
MATERIALS AND METHODS


Eighty-six AR patients aged 60-75 years old were randomly divided in the control and treatment group as 1:1 ratio. The control group was treated with standard pharmacotherapy while the treatment group was treated with SLIT plus pharmacotherapy on demand. Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events were evaluated in the baseline and after 6-months, 12-months and 24-months treatment.
RESULTS


Twenty-five (58.1%) subjects in the treatment group and 20 (46.5%) subjects in the control group completed the study (P > 0.05). The major reasons for premature cessation were out of touch and relieved symptoms. At the same time, CSMS and VAS of the patients over 60 years old in both groups significantly decreased from baseline to any post-baseline time point (all P < 0.05). The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
CONCLUSION


41.9% of the patients dropped out within 2 years of SLIT treatment and the major reasons for premature cessation were out of touch and relieved symptoms. This study suggested that SLIT plus pharmacotherapy provided a greater clinical benefit than pharmacotherapy alone at two years.",2020,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
","['house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60\xa0years old', 'Eighty-six AR patients aged 60-75\xa0years old', 'patients aged 60 to 75\xa0years old with house dust mite-induced allergic rhinitis']","['sublingual immunotherapy', 'sublingual immunotherapy (SLIT', 'standard pharmacotherapy', 'SLIT plus pharmacotherapy']","['Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events', 'CSMS and VAS', 'Efficacy and adherence']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",86.0,0.0113207,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Biyu', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Shaopeng', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Qinhua', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China. Electronic address: liruiyu_phd@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102538']
2197,32451321,Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent in Patients at High Risk of Restenosis: The COMPARE-ABSORB Randomized Clinical Trial.,"AIMS


The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS).
METHODS AND RESULTS


The COMPARE-ABSORB trial was an investigator-initiated, prospective randomized study. Patients at high risk of restenosis were randomly assigned to receive either BVS or everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization at 1 year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1 %) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval (CI) -1.2%-3.0%, P non-inferiority &lt; 0.001). Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
CONCLUSIONS


In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at 1 year. BVS carried a higher risk of device thrombosis and TVMI than EES.",2020,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","['1,670 patients were recruited (BVS 848 patients and EES 822 patients', 'Patients at High Risk of Restenosis', 'patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS', 'Patients at high risk of restenosis']","['Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent', 'BVS or everolimus-eluting stent (EES']","['target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization', 'TLF', 'TVMI', 'thrombosis and TVMI rate', 'Definite or probable device thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",1670.0,0.283667,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","[{'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maastad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': ''}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kocka', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Robert-Jan M', 'Initials': 'RM', 'LastName': 'van Geuns', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01079']
2198,32451528,Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial.,"OBJECTIVE


Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain.
DESIGN


Randomized comparison trial.
SETTING


Outpatient clinics at the West Los Angeles VA Medical Center.
SUBJECTS


Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain.
METHODS


Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up.
RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had >30% pain reduction, one-third had >50%, and 12.5% had >70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance.
CONCLUSIONS


This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.",2020,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","['Fifty-three veterans (mean age\u2009=\u200973.5\u2009years, 92.4% male) with chronic musculoskeletal pain', 'patients with chronic musculoskeletal pain', 'Patients', 'older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain', 'chronic pain', 'Older Adults with Chronic Musculoskeletal Pain', 'Outpatient clinics at the West Los Angeles VA Medical Center']","['Emotional awareness and expression therapy (EAET', 'EAET with CBT', 'Cognitive Behavioral Therapy', 'Psychotherapy', 'cognitive behavioral therapy (CBT']","['pain reduction', 'Pain Reduction', 'Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes', 'small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance', 'pain', 'pain severity', 'Emotional Awareness and Expression Therapy']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.074013,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","[{'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Yarns', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Justina T', 'Initials': 'JT', 'LastName': 'Cassidy', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Steers', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Osato', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Providence Hospital, Southfield, Michigan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Sultzer', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California, Irvine School of Medicine, Irvine, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa145']
2199,32451555,Abobotulinumtoxina injections in shoulder muscles for adult upper limb spasticity: Results from a phase 4 real-world study and a phase 3 open-label trial.,"OBJECTIVE


To compare patients with upper limb spasticity who did or did not receive abobotulinumtoxinA (Dysport®) in shoulder muscles during 2 international clinical studies.
DESIGN


Phase 4 Upper Limb International Spasticity Study-II (ULIS-II; NCT01020500) endpoints: primary goal selection and achievement. Phase 3 Adult Upper Limb open-label study (NCT01313299) endpoints: Disability Assessment Scale principal target of treatment and mean (standard deviation) change from baseline to week 4 (last cycle involving shoulder muscles) for pain, Modified Frenchay Scale (active function), and Tardieu Scale parameters.
PATIENTS


Shoulder population: patients receiving abobotulinumtoxinA injections in shoulder muscles (n = 82 and n = 96 in ULIS-II and adult upper limb open-label study, respectively); non-shoulder population: patients not injected in shoulder muscles (n = 239 and n = 158, respectively).
RESULTS


ULIS-II: primary treatment goal was pain in 25.6% vs 8.4% patients (3-fold higher) in shoulder vs non-shoulder populations, with high goal-achievement for pain reduction (85.7%). Adult upper limb open-label study: Disability Assessment Scale pain selection was 9.5% vs 5.1% (almost double); pain improvements were -0.7 (0.9) vs -0.4 (0.7); active function improvements were +0.60 (0.80) vs +0.33 (0.79), in shoulder vs non-shoulder populations, respectively. Tardieu scale parameters were improved.
CONCLUSION


High goal achievement rates for pain reduction and improved active function were observed in patients receiving abobotulinumtoxinA in shoulder muscles.",2020,Disability Assessment Scale pain selection was 9.5% vs 5.1% (almost double); pain improvements were -0.7 (0.9) vs -0.4 (0.7); active function improvements were +0.60 (0.80),"['Shoulder population: patients receiving', 'Adult upper limb open-label study', 'in shoulder muscles (n\u2009=\u200982 and n\u2009=\u200996 in ULIS-II and adult upper limb open-label study, respectively); non-shoulder population: patients not injected in shoulder muscles (n\u2009=\u2009239 and n\u2009=\u2009158, respectively', 'adult upper limb spasticity', 'patients with upper limb spasticity who did or did not receive']","['abobotulinumtoxinA injections', 'abobotulinumtoxinA (Dysport®', 'abobotulinumtoxinA', 'Abobotulinumtoxina injections']","['pain reduction', 'Disability Assessment Scale pain selection', 'active function improvements', 'pain reduction and improved active function', 'pain improvements', 'pain', 'Tardieu scale parameters', 'Disability Assessment Scale principal target of treatment and mean (standard deviation) change from baseline to week 4 (last cycle involving shoulder muscles) for pain, Modified Frenchay Scale (active function), and Tardieu Scale parameters']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687023', 'cui_str': 'Structure of skeletal muscle of shoulder'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0687023', 'cui_str': 'Structure of skeletal muscle of shoulder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0289473,Disability Assessment Scale pain selection was 9.5% vs 5.1% (almost double); pain improvements were -0.7 (0.9) vs -0.4 (0.7); active function improvements were +0.60 (0.80),"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lejeune', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, BE-1200 Brussels, Belgium. E-mail: thierry.lejeune@uclouvain.be.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Khatkova', 'Affiliation': ''}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Turner-Stokes', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': ''}, {'ForeName': 'Jovita', 'Initials': 'J', 'LastName': 'Balcaitiene', 'Affiliation': ''}, {'ForeName': 'François Constant', 'Initials': 'FC', 'LastName': 'Boyer', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2695']
2200,32451615,Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.,"OBJECTIVE


SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED.
METHODS


Eligible participants who completed 1-2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION.
RESULTS


Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0-24 was 0.21 (0.16-0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
CONCLUSIONS


The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.",2020,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","['up to 6\xa0years in participants with relapsing multiple sclerosis', 'Ninety percent (410/455) of participants who completed treatment', 'relapsing-remitting multiple sclerosis', 'Eligible participants who completed 1-2\xa0years of daclizumab beta treatment in SELECT/SELECTION received']","['daclizumab beta for ', 'daclizumab beta 150\xa0mg subcutaneously every 4\xa0weeks', 'daclizumab', 'daclizumab beta treatment', 'daclizumab beta']","['annualized relapse rate', 'serious adverse event (excluding multiple sclerosis relapse', 'serious hepatic events', 'clinical and radiologic outcomes', 'Overall incidence of 24-week confirmed disability progression', 'brain volume', 'Overall, hepatic events', 'immune-mediated encephalitis']","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}]",,0.0418529,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'St. Josef-Hospital/Ruhr-University Bochum, 44791, Bochum, Germany. ralf.gold@rub.de.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': 'Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Eva Kubala', 'Initials': 'EK', 'LastName': 'Havrdova', 'Affiliation': 'Department of Neurology, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Hospital Vall d'Hebron University, Barcelona, Spain.""}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Stefoski', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Randy R', 'Initials': 'RR', 'LastName': 'Robinson', 'Affiliation': 'AbbVie Inc., Redwood City, CA, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Fam', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Chalkias', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giannattasio', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lima', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Castro-Borrero', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]",Journal of neurology,['10.1007/s00415-020-09835-y']
2201,32451659,Early sonographic evaluation of the placenta in cases with IUGR: a pilot study.,"PURPOSE


The objective of this study was to evaluate the feasibility and value of measuring early placental echogenicity to predict fetal intrauterine growth restriction (IUGR).
METHODS


This is a single center, retrospective cohort study. Early ultrasound examination (6 + o to 8 + 6 weeks of gestation in singleton pregnancies) was used to measure placental dimensions and placental echogenicity. A ratio between placental echogenicity and myometrial echogenicity (PE/ME-ratio) was calculated for each patient. Study population was assigned to either the IUGR group or the control group based on clinical data.
RESULTS


184 eligible pregnancies were analysed. 49 patients were included in our study. Of those, 9 (18.37%) cases were affected by IUGR and 40 (81.63%) were controls. Measuring the placental echogenicity was feasible in all cases. IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
CONCLUSION


Our results showed that measuring placental echogenicity is feasible in the early first trimester and demonstrated a significantly lower placental echogenicity in fetuses with subsequent IUGR. Further prospective studies are needed to validate those results.",2020,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
","['184 eligible pregnancies', 'cases with IUGR', '49 patients were included in our study']","['fetal intrauterine growth restriction (IUGR', 'IUGR']","['placental echogenicity', 'placental echogenicity and myometrial echogenicity (PE/ME-ratio', 'feasibility and value of measuring early placental echogenicity', 'placental outcomes']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",49.0,0.0319917,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Walter', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Böckenhoff', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Geipel', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Gembruch', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Engels', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. alexander.engels@outlook.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05601-7']
2202,32451660,Ovarian stimulation after dehydroepiandrosterone supplementation in poor ovarian reserve: a randomized clinical trial.,"OBJECTIVE


This study aimed at improving fertility rates among infertile women with poor ovarian reserve.
METHODS


This was a randomized clinical trial conducted in the outpatient clinic of a tertiary hospital. We recruited infertile women with poor ovarian reserve. The study population was divided into 2 groups, each of 25 participants. Both had induction of ovulation for three consecutive cycles. Study group took DHEA supplementation 25 mg/8 h for two consecutive cycles before induction of ovulation. Both groups were compared for outcomes of induction. Baseline ovarian reserve tests and antral follicle count (AFC) were done for both groups before induction of ovulation. The study group repeated these baseline tests after DHEA treatment to compare ovarian reserve before and after DHEA supplementation. Outcome measures were the number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection.
RESULTS


The study group baseline investigations after DHEA treatment showed a statistically significant improvement compared to the control group. The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
CONCLUSION


DHEA may help many poor responders so better considered for poor responder patients.
TRIAL REGISTRATION NUMBER


PACTR201911829230395.",2020,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","['poor ovarian reserve', 'outpatient clinic of a tertiary hospital', 'infertile women with poor ovarian reserve']","['DHEA supplementation', 'dehydroepiandrosterone supplementation']","['Ovarian stimulation', 'Baseline ovarian reserve tests and antral follicle count (AFC', 'induction of ovulation', 'fertility rates', 'number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600225', 'cui_str': 'Vesicular ovarian follicle structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0179031', 'cui_str': 'Ampule'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.167646,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt. prince.ma939@yahoo.com.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Kishk', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Metawie', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Albiely', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05603-5']
2203,32451708,Bone turnover markers as an aid to monitor osteoporosis following allogeneic hematopoietic stem cell transplantation.,"Bone turnover markers (BTMs) are useful parameters for assessing fracture risk and unlike bone mineral density (BMD), can be measured at any institution. However, BTM values have not been established in patients post-allogeneic hematopoietic stem cell transplantation (allo-HSCT). We investigated the practicality of BTMs in patients who underwent allo-HSCT by measuring levels of the serum bone resorption marker, tartrate-resistant acid phosphatase-5b (TRACP-5b), and the bone formation marker, bone-specific alkaline phosphatase (BAP), together with BMD, 1 month before and 6 months after allo-HSCT. Patients were classified into either the alendronate group (n = 14) if alendronate treatment (35 mg orally per week) was administered before allo-HSCT or within 1 month after allo-HSCT, or the control group (n = 16), in which patients did not receive alendronate treatment. Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups. Additionally, the percentage changes in BMD at the lumbar spine were negatively associated with the TRACP-5b levels 6 months after allo-HSCT (p = 0.03, r = 0.40). Our results indicate the possible effectiveness of alendronate treatment in allo-HSCT patients. BTM levels could be useful to monitor the BMD changes.",2020,"Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups.","['allogeneic hematopoietic stem cell transplantation', 'patients post-allogeneic hematopoietic stem cell transplantation (allo-HSCT', 'allo-HSCT patients', 'patients who underwent allo-HSCT by measuring levels of the serum bone resorption marker, tartrate-resistant acid phosphatase-5b (TRACP-5b), and the bone formation marker, bone-specific alkaline phosphatase (BAP), together with BMD, 1\xa0month before and 6\xa0months after allo-HSCT']","['alendronate treatment', 'alendronate treatment (35\xa0mg orally per week) was administered before allo-HSCT', 'alendronate']","['femoral neck', 'BMD at the lumbar spine', 'Bone turnover markers (BTMs', 'bone mineral density (BMD', 'TRACP-5b levels', 'BAP levels', 'BTM levels']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}]",,0.0279843,"Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups.","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kurosawa', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Doki', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan. n-doki@cick.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Senoo', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Shinshu University School of Medicine, Matsumoto city, Nagano, 390-8621, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Kishida', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Nagata', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Konishi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kaito', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Yoshifuji', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Matsuyama', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Shirane', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Inamoto', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Toya', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Najima', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Muto', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kakihana', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Sakamaki', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Ohashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}]",Annals of hematology,['10.1007/s00277-020-04090-7']
2204,32451735,The effect of forskolin on membrane clock and calcium clock in the hypoxic/reoxygenation of sinoatrial node cells and its mechanism.,"BACKGROUND


In this study, we investigated the effect of forskolin (FSK, a selective adenylate cyclase agonist) on the automatic diastolic depolarization of sinus node cells (SNC) with hypoxia/reoxygenation (H/R) injury.
METHODS


The SNC of the newborn rat was randomly assigned into the control group, the H/R (H/R injury) group, or the H/R + FSK (H/R injury + FSK treatment) group. Patch-clamp was performed to record the action potential and electrophysiological changes. The cellular distribution of intracellular calcium concentration was analyzed by fluorescence staining.
RESULTS


Compared with the control cells, spontaneous pulsation frequency (SPF) and diastolic depolarization rate (DDR) of H/R cells were reduced from 244.3 ± 10.6 times/min and 108.7 ± 7.8 mV/s to 130.5 ± 7.6 times/min and 53.4 ± 6.5 mV/s, respectively. FSK significantly increased SPF and DDR of H/R cells to 208.3 ± 8.3 times/min and 93.2 ± 8.9 mV/s (n = 15, both p < 0.01), respectively. H/R reduced the current densities of I f , I Ca,T  and inward I NCX , which were significantly increased by 10 μM FSK treatment (n = 15, p < 0.01). Furthermore, reduced expression of HCN4 and NCX1.1 channel protein were significantly increased by FSK. Inhibitor studies showed that both SQ22536 (a selective adenylate cyclase inhibitor) and H89 (a selective protein kinases A [PKA] inhibitor) blocked the effects of FSK on SPF and DDR.
CONCLUSIONS


H/R causes pacemaker dysfunction in newborn rat sinoatrial node cells leading to divergence of the DD and the slow of spontaneous APs, which change can be dramatically reversed by FSK through increasing I NCX  and I f  current in H/R injury.",2020,H/R reduced the current densities of I,[],"['forskolin (FSK', 'Patch-clamp', 'forskolin', 'FSK', 'SQ22536']","['spontaneous pulsation frequency (SPF) and diastolic depolarization rate (DDR) of H/R cells', 'reduced expression of HCN4 and NCX1.1 channel protein', 'SPF and DDR of H/R cells', 'cellular distribution of intracellular calcium concentration']",[],"[{'cui': 'C0917964', 'cui_str': 'Coleonol'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0276004,H/R reduced the current densities of I,"[{'ForeName': 'Jian-Cheng', 'Initials': 'JC', 'LastName': 'Zhang', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Xie', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Hong-Lin', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'National Heart Research Institute, Singapore, Singapore.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China. liyangbsh@163.com.""}, {'ForeName': 'Peng-Li', 'Initials': 'PL', 'LastName': 'Zhu', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China. zpl7755@126.com.""}]",Pharmacological reports : PR,['10.1007/s43440-020-00094-2']
2205,32451777,Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.,"BACKGROUND


Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes.
METHODS


In total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05.
RESULTS


Of the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4-7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p < 0.001). Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001). In total, 66% of patients reported a > 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%.
CONCLUSION


CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.",2020,"Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001).","['Of the 117 US treated patients 100\xa0(85%) were available for review with a mean follow-up of 6.4\xa0years (5.4-7.8\xa0years', 'chronic low back pain']","['intraosseous basivertebral nerve ablation', 'BVN ablation']","['mean change in ODI', 'complete pain resolution', 'Mean ODI score', 'function and pain', 'pain', 'Mean reduction in VAS pain score', 'ODI, VAS, postablation treatments, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",117.0,0.243102,"Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001).","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Fischgrund', 'Affiliation': 'William Beaumont Hospital, Oakland University School of Medicine, 3601 W 13 Mile Road, Royal Oak, MI, 48073, USA. jsfischgrund37@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rhyne', 'Affiliation': 'OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Macadaeg', 'Affiliation': 'Indiana Spine Group, 13225 North Meridian Street, Carmel, IN, 46032, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': 'Pacific Sports and Spine, 74B Centennial Loop, Suite 300, Eugene, OR, 97401, USA.'}, {'ForeName': 'Evish', 'Initials': 'E', 'LastName': 'Kamrava', 'Affiliation': 'The Spine Institute, 2811 Wilshire Boulevard, Suite 850, Santa Monica, CA, 90403, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Yeung', 'Affiliation': 'Desert Institute for Spine Care, 1635 E Myrtle Avenue, Suite 400, Phoenix, AZ, 85020, USA.'}, {'ForeName': 'Eeric', 'Initials': 'E', 'LastName': 'Truumees', 'Affiliation': 'Seton Spine & Scoliosis Center, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaufele', 'Affiliation': 'Drug Studies America, 400 Tower Road NE, Suite 150, Marietta, GA, 30060, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Memorial Orthopedic Surgical Group, Department of Surgery, Long Beach Memorial Medical Center, 2760 Atlantic Avenue, Long Beach, CA, 90806, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, 9020 Stony Point Parkway, S-140, Richmond, VA, 23235, USA.'}, {'ForeName': 'David Greg', 'Initials': 'DG', 'LastName': 'Anderson', 'Affiliation': 'Rothman Orthopedic Institute, 3300 Tillman Drive, 2nd Floor, Glenview Corporate Center, Bensalem, PA, 19020, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Buxton', 'Affiliation': 'Maine Medical Partners Neurosurgery and Spine, 195 Fore River Parkway, Suite 490, Portland, ME, 04102, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Spine Care Medical Group, 455 Hickey Boulevard, Suite 310, Daly City, CA, 94015, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sikorsky', 'Affiliation': 'Michigan Orthopedic Institute, 26025 Lahser Road, Suite 200B, Southfield, MI, 48033, USA.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06448-x']
2206,32451788,Motivational Interviewing to Promote the Effectiveness of Selective Prevention: an Integrated School-Based Approach.,"School Mental Health prevention approaches that use multi-tiered systems are advancing rapidly. However, there is a relative shortage of effective selective prevention programs feasible to implement within the school context. To optimize the effectiveness of selective prevention in this context, a Motivational Interviewing (MI)-based prevention program for an adolescent student population was developed and tested. Footprints utilizes MI to increase engagement in modular Cognitive-Behavioral Therapy and to promote academic protective factors. In this study, forty-three adolescents were randomly assigned to Footprints or a treatment-as-usual waitlist control. Participants in the experimental condition demonstrated significant increases in behavioral and emotional functioning, self-efficacy to regulate behaviors, positive expectations for success, academic motivation, and grades in mathematics. Simultaneously, Footprints received high ratings for feasibility and acceptability within a dynamic school context. This exploratory efficacy evaluation provides initial support for MI's potential to promote the effectiveness of school-based prevention programs and warrants further study.",2020,"Participants in the experimental condition demonstrated significant increases in behavioral and emotional functioning, self-efficacy to regulate behaviors, positive expectations for success, academic motivation, and grades in mathematics.","['forty-three adolescents', 'adolescent student population']","['Motivational Interviewing (MI)-based prevention program', 'Motivational Interviewing']","['behavioral and emotional functioning, self-efficacy to regulate behaviors, positive expectations for success, academic motivation, and grades in mathematics']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]",43.0,0.0151052,"Participants in the experimental condition demonstrated significant increases in behavioral and emotional functioning, self-efficacy to regulate behaviors, positive expectations for success, academic motivation, and grades in mathematics.","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Terry', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, 29208, USA. johndavidterry@gmail.com.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Weist', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, 29208, USA.'}, {'ForeName': 'Gerald G', 'Initials': 'GG', 'LastName': 'Strait', 'Affiliation': 'University of Houston-Clear Lake, Houston, TX, USA.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, 29208, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01124-4']
2207,32451827,Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial.,"OBJECTIVE


To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura.
METHODS


This randomized-controlled trial was done at the Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria. The 50 patients (21 females, mean age 9.9 y) consecutively enrolled were randomized by block randomization to two study groups, with one group (n = 25) receiving oral paracetamol (15 mg/kg/dose) and the other group (n = 25) oral ibuprofen (10 mg/kg/dose), at home, during a single episode of acute migraine headache. The study drugs were dispensed in a blinded fashion. Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief (≥2-point reduction from the baseline) two-hours after the study drug intake were the primary outcomes. Side-effects to the study drugs were actively solicited. Non-parametric tests for paired data were used.
RESULTS


The two groups were similar at baseline. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study. Both pain-freedom (32% vs. 28%, P = 0.77) and pain-relief (80% vs. 80%, P = 0.86) were not significantly different between the Paracetamol and Ibuprofen groups, respectively. Ten (23.2%) children had a side-effect due to the study drug, with no significant difference between the groups (13.6% vs. 33.3%; P = 0.11).
CONCLUSIONS


Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.",2020,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"['acute migraine attacks in children', '50 patients (21 females, mean age 9.9 y) consecutively enrolled', 'Migraine Headache in Children', 'children with migraine without aura', 'Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria', 'Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study']","['ibuprofen', 'paracetamol and ibuprofen', 'Ibuprofen', 'Paracetamol versus Ibuprofen', 'oral paracetamol and oral ibuprofen', 'oral paracetamol']","['pain-relief', 'Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief', 'pain-freedom', 'acute headache']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}]",43.0,0.160754,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pavithra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India. drdmishra@gmail.com.'}, {'ForeName': 'Shatrishna', 'Initials': 'S', 'LastName': 'Behera', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03315-x']
2208,32451933,"Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism.","How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications. 1450 patients, aged ≥ 75 years, after at least 3 months of anticoagulation treatment for a first VTE episode, are double-blind randomized to receive for 12 months either sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily + indistinguishable placebo, or indistinguishable placebo. Primary outcomes for efficacy are the composite of death for VTE and recurrent VTE, and occurrence of MB for safety. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, and MB + clinically relevant non-MB. The first patient is scheduled to be randomized in May 2020. The study protocol has been approved by AIFA (Agenzia Italiana del Farmaco) and the Ethics Committee of the coordinating center. Written informed consent will be obtained from all patients prior to study participation. Jason study is an investigator-initiated trial, promoted by ""Arianna Anticoagulazione"" Foundation, Bologna, Italy, and supported by Alfasigma, Bologna, Italy. Study findings will be disseminated to participant centers, at research conferences and in peer-reviewed journals. Trial registration numbers NCT04257487; EudraCT (2019-000570-33).",2020,"The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications.","['elderly patients', '1450 patients, aged\u2009≥\u200975\xa0years, after at least 3\xa0months of anticoagulation treatment for a first VTE episode', 'elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy', 'elderly patients after a first venous thromboembolism']","['sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily\u2009+\u2009indistinguishable placebo, or indistinguishable placebo', 'sulodexide', 'placebo']","['stroke, cardiovascular death and other thromboembolic events, and MB\u2009+\u2009clinically relevant non-MB', 'efficacy and safety', 'composite of death for VTE and recurrent VTE, and occurrence of MB for safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0017973', 'cui_str': 'Mucopolysaccharide'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.393018,"The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications.","[{'ForeName': 'Gualtiero', 'Initials': 'G', 'LastName': 'Palareti', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy. gualtiero.palareti@unibo.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Legnani', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Antonucci', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Zorzi', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Angelo A', 'Initials': 'AA', 'LastName': 'Bignamini', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Specialization in Hospital Pharmacy, University of Milan, Milan, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Lodigiani', 'Affiliation': 'Thrombosis and Hemorrhagic Diseases Unit, Humanitas Research Hospital and Humanitas University, Rozzano (Milan), Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Divisione Di Ematologia, Centro Malattie Emorragiche E Trombotiche, AULSS8 Berica, Vicenza, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bertù', 'Affiliation': ""Centro Di Ricerca Sulle Malattie Tromboemboliche E Le Terapie Antitrombotiche, Università Degli Studi dell'Insubria, Varese, Italy.""}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Pengo', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Testa', 'Affiliation': 'Department of Laboratory Medicine, Haemostasis and Thrombosis Center, AO Istituti Ospitalieri, Cremona, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': ""Dipartimento Di Medicina E Chirurgia, Università Degli Studi Dell'Insubria, Varese, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Prisco', 'Affiliation': 'DMSC Università Di Firenze, SOD Medicina Interna Interdisciplinare, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Prandoni', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Centro Trombosi, Azienda Ospedaliera Careggi, Florence, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-020-02381-5']
2209,32451964,Sample size calculation of clinical trials in geriatric medicine.,"A preliminary step when planning a randomized clinical trial (RCT) is the sample size calculation. This is the determination of the optimal number of patients which ensures an adequate power to the study to detect as statistically significant a certain between-arms difference, if any, in the frequency/magnitude of a specific endpoint. The sample size calculation is performed by specific calculators requiring as input variables the expected effect size, the alpha error (α), the beta error (β) and the allocation ratio, this latter being the ratio between the number of participants allocated to the arms of a RCT. Herein, we provide a series of examples of sample size calculation in the context of superiority RCTs in elderly.",2020,"The sample size calculation is performed by specific calculators requiring as input variables the expected effect size, the alpha error (α), the beta error (β) and the allocation ratio, this latter being the ratio between the number of participants allocated to the arms of a RCT.",[],[],[],[],[],[],,0.0879419,"The sample size calculation is performed by specific calculators requiring as input variables the expected effect size, the alpha error (α), the beta error (β) and the allocation ratio, this latter being the ratio between the number of participants allocated to the arms of a RCT.","[{'ForeName': 'Graziella', 'Initials': 'G', 'LastName': ""D'Arrigo"", 'Affiliation': 'Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Roumeliotis', 'Affiliation': 'Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Torino', 'Affiliation': 'Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tripepi', 'Affiliation': 'Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy. gtripepi@ifc.cnr.it.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01595-z']
2210,32452060,Skin seeding technique with 0.5-mm micropunch grafting for vitiligo irrespective of the epidermal-dermal orientation: Animal and clinical studies.,"Micropunch grafting is the simplest surgical intervention for refractory vitiligo but is tedious and time-consuming. Therefore, we aimed to verify the efficacy and safety of dermal orientation grafting using motorized 0.5-mm micropunch grafting for vitiligo. In a preliminary animal study, 12-week-old rats were used to observe the healing process after the transplantation of dermal orientation grafts with various punch sizes. In a clinical trial, a total of 100 vitiligo patches in 50 patients with stable vitiligo were randomly allocated to motorized 0.5-mm micropunch grafting in epidermal and dermal orientations, respectively. The grafts were implanted at intervals of 5 mm at the recipient site. Treatment success was defined as greater than 75% repigmentation. In the animal study, all grafts were shown to be well integrated into the recipient site within 3 weeks. In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively. In conclusion, we demonstrated that this new grafting method irrespective of epidermal-dermal orientation using motorized 0.5-mm micropunch grafting was effective and safe. We have named this the ""skin seeding technique"" and it differs from traditional punch grafting in that it can be performed regardless of the graft orientation.",2020,"In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively.","['100 vitiligo patches in 50 patients with stable vitiligo', 'vitiligo']","['Skin seeding technique with 0.5-mm micropunch grafting', 'dermal orientation grafting using motorized 0.5-mm micropunch grafting', 'Micropunch grafting', 'motorized 0.5-mm micropunch grafting']","['Treatment success', 'efficacy and safety', 'cobblestone appearance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0449871', 'cui_str': 'Use of graft'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",50.0,0.0311647,"In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively.","[{'ForeName': 'Dong Seok', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Eureka Skin & Laser Clinic, Seoul, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Han Na', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'In Hye', 'Initials': 'IH', 'LastName': 'Choi', 'Affiliation': ""Department of Dermatology, Bucheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Sung Hye', 'Initials': 'SH', 'LastName': 'Eun', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Jiehoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Dr Kim's Skin & Laser Clinic, Suwon, Korea.""}, {'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}]",The Journal of dermatology,['10.1111/1346-8138.15390']
2211,32452085,Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): results in the pre-specified subgroup with heart failure.,"AIMS


The AMBER trial demonstrated that concomitant use of patiromer enabled the more persistent use of spironolactone by reducing the risk of hyperkalaemia in patients with resistant hypertension and advanced chronic kidney disease. We report herein the pre-specified subgroup analysis in patients with heart failure (HF).
METHODS AND RESULTS


Participants were randomly assigned (1:1) to receive either placebo or patiromer (8.4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Dose titrations were permitted after 1 week for patiromer/placebo and after 3 weeks for spironolactone. The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomized patients (intention to treat). A total of 295 patients were enrolled, of whom 132 (45%) had HF. In the HF subgroup, 68.1% of patients receiving placebo remained on spironolactone at week 12, compared with 84.1% of patients receiving patiromer (P = 0.0504). The reason for discontinuation from spironolactone use was hyperkalaemia in the majority of both groups. There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
CONCLUSIONS


Consistent with the overall AMBER trial results, this pre-specified subgroup analysis in patients with HF, resistant hypertension and advanced chronic kidney disease demonstrated that patiromer enabled more persistent use of spironolactone by reducing the risk of hyperkalaemia.",2020,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","['patients with resistant hypertension and chronic kidney disease', 'Participants', 'A total of 295 patients were enrolled, of whom 132 (45%) had HF', 'patients with resistant hypertension and advanced chronic kidney disease', 'patients with heart failure (HF']","['placebo or patiromer (8.4\xa0g once daily), in addition to open-label spironolactone', 'spironolactone', 'placebo']","['Efficacy endpoints and safety', 'risk of hyperkalaemia', 'AMBER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0242864', 'cui_str': 'Amber'}]",295.0,0.129969,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Science University College London (UCL) and National Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Martha R', 'Initials': 'MR', 'LastName': 'Mayo', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Arthur', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackourey', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1860']
2212,32452128,Spironolactone dose in Heart Failure with Preserved Ejection Fraction: findings from TOPCAT.,"BACKGROUND


Spironolactone up-titration may be limited by side effects that could be minimized at lower than target doses, whether lower than target doses remain efficacious is unknown. In TOPCAT, spironolactone (or placebo) were started at 15 mg/day, and increased up to a maximum of 45 mg/day. The prognostic implications related to spironolactone dose are is yet to be reported.
AIMS


To assess the average spironolactone/placebo doses provided during the trial, overall and within ""high-risk"" subgroups (e.g. elderly, renal dysfunction, high potassium); discontinuation rates; and the efficacy of lower than target doses in HFpEF.
METHODS


1767 patients from ""TOPCAT-Americas"" were included. Linear, logistic and Cox regressions were applied.
RESULTS


Patients randomized to spironolactone received lower doses than placebo: 22.5 (15.0-27.5)mg/day vs. 27.5 (17.5-27.5)mg/day; p < 0.001. Patients aged≥75 years, with an eGFR≤60 mL/min/1.73m 2  , and with a K +  > 4.5 mmol/L, received lower spironolactone doses (median≈20 mg/day). This pattern of dose-differences was not observed in patients taking placebo, where the between-subgroup placebo doses were similar (spironolactone-placebo by subgroup interaction p  < 0.05). Among patients taking spironolactone, 25.4% discontinued the drug during the first year, compared with 18.3% of the patients taking placebo; p < 0.001. The discontinuation rates in the aforementioned ""high-risk"" subgroups reached 30% during the first year. Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1). Spironolactone discontinuation was associated with a 2 to 4-fold higher risk of subsequent events.
CONCLUSION


Spironolactone (but not placebo) was used at lower doses among the elderly, those with renal dysfunction and with higher potassium levels. The effect of spironolactone was homogenous across these subgroups. In patients unable to tolerate ""target"" doses, a low-dose strategy should be preferred to stopping treatment. This article is protected by copyright. All rights reserved.",2020,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"['1767 patients from ""TOPCAT-Americas"" were included', 'Patients', 'Heart Failure with Preserved Ejection Fraction']","['spironolactone', 'Spironolactone', 'spironolactone-placebo', 'spironolactone/placebo', 'TOPCAT, spironolactone (or placebo', 'placebo']","['discontinuation rates', 'HFH/CVD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1767.0,0.207414,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, US.""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, US.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, US.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.1909']
2213,32452161,Effectiveness of bibliotherapy in alleviating examination stress on college students: a quasi-experimental trial.,"BACKGROUND


Examination stress is a prevalent mental health disorder among college students in response to academic life.
OBJECTIVES


The study aimed to explore cognitive-behavioural therapy (CBT) and study skills training based bibliotherapy as an effective way to help female undergraduates to better cope with examination stress.
METHODS


A total of 121 students were randomly allocated to an experimental group or control group. Students in the experimental group used self-help materials, as a bibliotherapy intervention, over 16 weeks. Students in the control group received no treatment. The students' examination stress levels were assessed, before and after the intervention using the Revised Test Anxiety scale. Data collected were investigated and analysed using t-tests.
RESULTS


There was a significant decrease in examination stress scores of students from the experimental group as compared with the control group.
DISCUSSION


The intervention model efficiently diminished the symptoms of examination stress of undergraduates in practice. Findings can be used as a reference for developing non-clinical techniques to overcome examination anxiety.
CONCLUSION


Findings have revealed that combined CBT with academic skills improvement based bibliotherapy may be efficient in lowering examination stress for female undergraduates. Librarians can contribute to improving the health of their societies.",2020,"There was a significant decrease in examination stress scores of students from the experimental group as compared with the control group.
","['female undergraduates to better cope with examination stress', 'female undergraduates', 'college students', 'A total of 121 students']","['bibliotherapy', 'bibliotherapy intervention', 'cognitive-behavioural therapy (CBT) and study skills training based bibliotherapy']",['examination stress scores'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",121.0,0.0218012,"There was a significant decrease in examination stress scores of students from the experimental group as compared with the control group.
","[{'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'Hamdan', 'Affiliation': 'Department of Libraries and Information, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Al Duaijy', 'Affiliation': 'Department of Libraries and Information, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Al Sawy', 'Affiliation': 'Department of Information Technology, Northern Border University, Arar, Saudi Arabia.'}]",Health information and libraries journal,['10.1111/hir.12312']
2214,32452176,[Analysis on clinical effects of two surgical approaches in percutaneous spinal endoscopy for L 5 S 1  disc herniation].,"OBJECTIVE


To analyze the clinical effects, complications and operational key points of the percutaneous endoscopic transforaminal discectomy (PETD) and percutaneous endoscopic interlaminar discectomy (PEID) in treating L 5 S 1  disc herniation.
METHODS


The clinical data of 158 patients with L5S1 disc herniation treated from July 2015 to March 2018 were restospectively analyzed. According to different surgical approaches, the patients were divided into PETD group or PEID group, 79 cases in each group. In PETD group, there were 41 males and 38 females, with an average age of (41.38±6.25) years and course of disease of (10.06±3.14) months. In PEID group, there were 43 males and 36 females, with an average age of (41.18±5.78) years and course of disease of (9.99±2.83) months. The operation length, intraoperative blood loss, intraoperative fluoroscopy times, days of hospital stay, and complications were recorded between two groups. Visual analogue score (VAS), Japanese Orthopedic Association(JOA) score, Oswestry Disability Index(ODI), modified Macnab criteria were used to assessed clinical effects after operation.
RESULTS


All patients completed surgery and were followed up for more than 1 year. (1) There were no significant differences in the intraoperative blood loss or hospitalization length between two groups( P >0.05). The operation length and intraoperative fluoroscopy times in PETD group were significantly higher than in PEID group ( P <0.05). (2)VAS, JOA scores, ODI at 1 week, 6 months, or 12 months after operation were significantly improved between two groups ( P <0.05), but there was no statistical significance between two groups( P >0.05). (3)The excellence rate was 89.87% (71 / 79) in PETD group and 87.34% (69 / 79) in PEID group at the latest follow-up, with no statistical significance( P >0.05). (4)Complications occurred in 2 cases in PETD group and in 3 cases in PEID group, with no significant differences between two groups.
CONCLUSION


The short term efficacy of the PETD is equal to that of the PEID for the L 5 S 1  disc herniation, but PEID is superior in the operation length, the access of stereotaxic puncture and intraoperative fluoroscopy times. The complications can be effectively reduced by following the indications, mastering the endoscopic technique, operating carefully and being familiar with the key points of common complications.",2020,The operation length and intraoperative fluoroscopy times in PETD group were significantly higher than in PEID group ( P <0.05).,"['43 males and 36 females, with an average age of (41.18±5.78) years and course of disease of (9.99±2.83) months', '158 patients with L5S1 disc herniation treated from July 2015 to March 2018 were restospectively analyzed', '41 males and 38 females, with an average age of (41.38±6.25) years and course of disease of (10.06±3.14) months']",['percutaneous endoscopic transforaminal discectomy (PETD) and percutaneous endoscopic interlaminar discectomy (PEID'],"['operation length, intraoperative blood loss', 'operation length and intraoperative fluoroscopy times', 'intraoperative blood loss or hospitalization length', '2)VAS, JOA scores, ODI', 'Visual analogue score (VAS), Japanese Orthopedic Association(JOA) score, Oswestry Disability Index(ODI), modified Macnab criteria', 'intraoperative fluoroscopy times, days of hospital stay, and complications']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",158.0,0.0199009,The operation length and intraoperative fluoroscopy times in PETD group were significantly higher than in PEID group ( P <0.05).,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}, {'ForeName': 'Sheng-Hua', 'Initials': 'SH', 'LastName': 'He', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}, {'ForeName': 'Ju-Yi', 'Initials': 'JY', 'LastName': 'Lai', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Feng', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hong', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Lan', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518033, Guangdong, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.05.004']
2215,32452208,"The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.","BACKGROUND


Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR.
HYPOTHESIS


Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at  P  < .10. The Cohen  d  was calculated to determine the effect size.
RESULTS


HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( P  < .05;  d  = 2.93). The primary outcome measure was knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque by 29% compared with the placebo group ( P  = .05;  d  = 0.80). Matrix metalloproteinase-3 (MMP3), which was used as an indirect biomarker of cartilage degradation, was 36% lower in the HGH group ( P  = .05;  d  = -1.34). HGH did not appear to be associated with changes in muscle volume or patient-reported outcome scores.
CONCLUSION


HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted.
REGISTRATION


NCT02420353 ( ClinicalTrials.gov identifier).",2020,Matrix metalloproteinase-3,"['patients undergoing ACLR', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'Anterior cruciate ligament (ACL) tears are common knee injuries', '19 male patients (aged 18-35 years) scheduled to undergo ACLR', 'patients undergoing ACLR are warranted']","['extensive rehabilitation after ACL reconstruction (ACLR', 'Recombinant Human Growth Hormone', 'Placebo', 'Human growth hormone (HGH', 'Matrix metalloproteinase-3', 'placebo or HGH', 'HGH', 'placebo']","['quadriceps strength and reduced MMP3 levels', 'knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque', 'adverse events', 'Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers', 'circulating insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}]","[{'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",19.0,0.277985,Matrix metalloproteinase-3,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Elizabeth R Sibilsky', 'Initials': 'ERS', 'LastName': 'Enselman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Olszewski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Gumucio', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edon', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Konnaris', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Carpenter', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Awan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Barkan', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520920591']
2216,32452275,A Novel Wearable Device for Motor Recovery of Hand Function in Chronic Stroke Survivors.,"Background.  In monkey, reticulospinal connections to hand and forearm muscles are spontaneously strengthened following corticospinal lesions, likely contributing to recovery of function. In healthy humans, pairing auditory clicks with electrical stimulation of a muscle induces plastic changes in motor pathways (probably including the reticulospinal tract), with features reminiscent of spike-timing dependent plasticity. In this study, we tested whether pairing clicks with muscle stimulation could improve hand function in chronic stroke survivors.  Methods.  Clicks were delivered via a miniature earpiece; transcutaneous electrical stimuli at motor threshold targeted forearm extensor muscles. A wearable electronic device (WD) allowed patients to receive stimulation at home while performing normal daily activities. A total of 95 patients >6 months poststroke were randomized to 3 groups: WD with shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care. Those allocated to the device used it for at least 4 h/d, every day for 4 weeks. Upper-limb function was assessed at baseline and weeks 2, 4, and 8 using the Action Research Arm Test (ARAT), which has 4 subdomains (Grasp, Grip, Pinch, and Gross).  Results.  Severity across the 3 groups was comparable at baseline. Only the paired stimulation group showed significant improvement in total ARAT (median baseline: 7.5; week 8: 11.5;  P  = .019) and the Grasp subscore (median baseline: 1; week 8: 4;  P  = .004).  Conclusion.  A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.",2020,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"['chronic stroke survivors', '95 patients >6 months poststroke', 'Chronic Stroke Survivors']","['pairing clicks with muscle stimulation', 'shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care']","['Upper-limb function', 'Grasp subscore', 'upper-limb function', 'total ARAT']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",95.0,0.0695364,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"[{'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shobhana', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Dwaipayan', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Sidharth Shankar', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Shubham', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Gangopadhyay', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Stuart N', 'Initials': 'SN', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320926162']
2217,32452284,"The immediate effects of passive hip joint mobilization on hip abductor/external rotator muscle strength in patients with anterior knee pain and impaired hip function. A randomized, placebo-controlled crossover trial.","BACKGROUND


Anterior knee pain (AKP) is often associated with persistent hip muscle weakness and facilitatory interventions may be beneficial for managing patients with AKP (pwAKP). Physiotherapists often employ passive oscillatory hip joint mobilizations to increase hip muscle function. However, there is little information about their effectiveness and the mechanisms of action involved.
OBJECTIVES


To investigate the immediate effects of passive hip joint mobilization on eccentric hip abductor/external rotator muscle strength in pwAKP with impaired hip function.
DESIGN


A double-blinded, randomized, placebo-controlled crossover design.
METHOD


Eighteen patients with AKP participated in two sessions of data collection with one week apart. They received passive hip joint mobilization or placebo mobilization in a randomized order. Eccentric hip muscle strength was measured immediately before and after each intervention using a portable hand-held dynamometer.
RESULTS


An ANCOVA with the sequence of treatment condition as the independent variable, the within-subject post-treatment differences as the dependent variable and the within-subject pre-treatment differences as the covariate was conducted. Patients showed a significant mean increase in eccentric hip muscle strength of 7.73% (p = 0.001) for the mobilization condition, compared to a mean decrease of 4.22% for the placebo condition. Seventeen out of eighteen participants reported having no pain during any of the strength testing.
CONCLUSION


These data suggest that passive hip joint mobilization has an immediate positive effect on eccentric hip abductor/external rotator muscle strength in pwAKP with impaired hip function, even in the absence of current pain.",2020,"Patients showed a significant mean increase in eccentric hip muscle strength of 7.73% (p = 0.001) for the mobilization condition, compared to a mean decrease of 4.22% for the placebo condition.","['patients with anterior knee pain and impaired hip function', 'patients with AKP (pwAKP', 'Eighteen patients with AKP participated in two sessions of data collection with one week apart', 'Anterior knee pain (AKP']","['hip abductor/external rotator muscle strength', 'passive hip joint mobilization', 'passive hip joint mobilization or placebo mobilization', 'placebo']","['Eccentric hip muscle strength', 'having no pain', 'eccentric hip muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0224320', 'cui_str': 'Structure of rotator muscle'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0234225', 'cui_str': 'No pain'}]",18.0,0.095434,"Patients showed a significant mean increase in eccentric hip muscle strength of 7.73% (p = 0.001) for the mobilization condition, compared to a mean decrease of 4.22% for the placebo condition.","[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfluegler', 'Affiliation': 'Faculty of Health and Well Being, Sheffield Hallam University , Sheffield, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Borkovec', 'Affiliation': 'Department of Statistics, Ludwig Maximilian University of Munich , Munich, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kasper', 'Affiliation': 'Private Physiotherapy Practice ""Teamphysios"" , Vienna, Austria.'}, {'ForeName': 'Sionnadh', 'Initials': 'S', 'LastName': 'McLean', 'Affiliation': 'Faculty of Health and Well Being, Sheffield Hallam University , Sheffield, UK.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2020.1765625']
2218,32452336,Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal.,"AIMS


Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal.
METHODS


In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC).
RESULTS


We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm.
CONCLUSION


The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.",2020,Problem Management Plus,"['women and men in an earthquake-affected region of rural Nepal', 'adults in earthquake-affected communities in Nepal', '121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1']","['control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG', 'locally adapted Group PM', 'Group Problem Management Plus', 'PM']","['feasibility and acceptability', 'Acceptability', 'depression symptoms assessed using the Patient Health Questionnaire (PHQ-9']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",121.0,0.0978027,Problem Management Plus,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sangraula', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ghimire', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Marahatta', 'Affiliation': 'World Health Organization, Country Office for Nepal, Kathmandu, Nepal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'M J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000414']
2219,32452344,Baricitinib in patients with rheumatoid arthritis with inadequate response to methotrexate: results from a phase 3 study.,"OBJECTIVES


This study evaluated the efficacy and safety of baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, in patients with moderately to severely active rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) therapy.
METHODS


In this phase 3, double-blind, 52-week, placebo-controlled study, 290 patients with moderately to severely active RA and inadequate response to MTX were randomly assigned 1:1 to placebo or baricitinib 4-mg once daily, stratified by country (China, Brazil, Argentina) and presence of joint erosions. Primary endpoint measures included American College of Rheumatology 20% response (ACR20) at week 12. Secondary endpoints included changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Disease Activity Score for 28-joint counts (DAS28)-high-sensitivity C-reactive protein (hsCRP), Simplified Disease Activity Index (SDAI) score ≤3.3, mean duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS 0-10), worst tiredness NRS, and worst joint pain NRS at week 12.
RESULTS


Most patients (approximately 80%) were from China. More patients achieved ACR20 response at week 12 with baricitinib than with placebo (58.6% vs. 28.3%; p<0.001). Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12. Through week 24, rates of treatment-emergent adverse events, including infections, were higher for baricitinib compared to placebo, while serious adverse event rates were similar between baricitinib and placebo.
CONCLUSIONS


In patients with RA who had an inadequate response to MTX, baricitinib was associated with significant clinical improvements as compared with placebo.",2020,"Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12.","['290 patients with moderately to severely active RA and inadequate response to MTX', 'patients with rheumatoid arthritis with inadequate response to', 'patients with moderately to severely active rheumatoid arthritis (RA']","['methotrexate (MTX) therapy', 'baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor', 'placebo or baricitinib', 'methotrexate', 'placebo']","['changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Disease Activity Score for 28-joint counts (DAS28)-high-sensitivity C-reactive protein (hsCRP), Simplified Disease Activity Index (SDAI) score ≤3.3, mean duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS 0-10), worst tiredness NRS, and worst joint pain NRS', 'HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain', 'serious adverse event rates', 'American College of Rheumatology 20% response (ACR20', 'rates of treatment-emergent adverse events, including infections', 'ACR20 response']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0266700', 'cui_str': 'Janiceps'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",290.0,0.435619,"Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12.","[{'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China. li99@bjmu.edu.cn.""}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xingfu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xiangpei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Spindler', 'Affiliation': 'Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Argentina.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'GuangHua Hospital, Shanghai, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Guochun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Haoxun', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Lujing', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Terence P', 'Initials': 'TP', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'CEPIC - Centro Paulista de Investigação Clinica e Serviços Médicos, Ipiranga São Paulo, Brazil.'}]",Clinical and experimental rheumatology,[]
2220,32452352,Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials.,"OBJECTIVES


To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire.
METHODS


In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
RESULTS


In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24.
CONCLUSIONS


Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.",2020,The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24.,"['naive patients with active psoriatic arthritis (PsA', 'patients with active PsA', 'active psoriatic arthritis', 'SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients']","['placebo', 'ixekizumab 80 mg every 4 weeks ', 'IXEQ4W, IXEQ2W or placebo', 'ixekizumab', 'adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo', 'biologic', 'IXEQ4W) or every 2 weeks (IXEQ2W']","['activity impairment domains of WPAI-SHP', 'activity impairment', 'MCID estimates for work productivity loss', 'work productivity loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.398156,The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, and Department of Pharmacy and Pharmacology, University of Bath, UK. w.tillett@nhs.net.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Trevelin Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California, San Diego (UCSD) School of Medicine, Division of Rheumatology, Allergy, and Immunology, San Diego, CA, USA.'}]",Clinical and experimental rheumatology,[]
2221,32452353,"The treatment of adult-onset Still's disease with anakinra, a recombinant human IL-1 receptor antagonist: a systematic review of literature.","Adult-onset Still's disease (AOSD) is a rare, inflammatory disease of unknown aetiology, generally affecting young adults and requiring immunosuppressive treatment. In the last few years, bio- logic disease-modifying anti-rheumatic drugs (bDMARDs) have been successfully used in refractory cases, based on the pathogenic role of inflammatory cytokines in AOSD. Amongst bDMARDs, several observations confirmed the clinical usefulness of anakinra, a recombinant human non-glycosylated IL-1 receptor antagonist, in AOSD. At present, the treatment is still largely empirical and due to the possible fallacious aspects of clinical judgement, in this work, we performed a systematic review of literature (SRL) to summarise the evidence regarding the treatment with anakinra in AOSD, analysing rate of complete remission, corticosteroids (CCSs)-sparing effect, long-term retention rate, and safety. After screening titles, abstracts and analysis of full text, 15 manuscripts were analysed: 1 open randomised multicentre trial with two parallel groups and 14 observational single-arm retrospective studies. Collectively, results of the present SRL suggest the effectiveness of anakinra in the treatment of patients with AOSD. Furthermore, patients with AOSD are likely to achieve a good clinical response with anakinra and these outcomes are associated with a largely favourable safety profile. Furthermore, the majority of patients treated with anakinra may achieve a complete remission, also in monotherapy. Finally, the treatment with anakinra is associated with an important CCSs-sparing effect, and, a large percentage of these patients may stop CCSs, thus reducing predictable long-term CCSs side effects without the occurrence of new flares.",2020,"Still's disease (AOSD) is a rare, inflammatory disease of unknown aetiology, generally affecting young adults and requiring immunosuppressive treatment.","['Adult-onset', ""adult-onset Still's disease with anakinra, a recombinant human IL-1 receptor antagonist"", 'patients with AOSD']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],15.0,0.0441575,"Still's disease (AOSD) is a rare, inflammatory disease of unknown aetiology, generally affecting young adults and requiring immunosuppressive treatment.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giacomelli', 'Affiliation': ""Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy. roberto.giacomelli@cc.univaq.it.""}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Sota', 'Affiliation': ""Research Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.""}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruscitti', 'Affiliation': ""Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Campochiaro', 'Affiliation': 'Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute; and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Colafrancesco', 'Affiliation': 'Rheumatology Unit, Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari Sapienza University, Rome, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Dagna', 'Affiliation': 'Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute; and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iacono', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Florenzo', 'Initials': 'F', 'LastName': 'Iannone', 'Affiliation': 'Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lopalco', 'Affiliation': 'Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sfriso', 'Affiliation': 'Department of Medicine - DIMED, University of Padova, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cantarini', 'Affiliation': ""Research Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.""}]",Clinical and experimental rheumatology,[]
2222,32452356,Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.,"BACKGROUND


Our Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias.
OBJECTIVES


The Fluoxetine Or Control Under Supervision (FOCUS) trial tested the hypothesis that fluoxetine improves recovery after stroke.
DESIGN


The FOCUS trial was a pragmatic, multicentre, parallel-group, individually randomised, placebo-controlled trial.
SETTING


This trial took place in 103 UK hospitals.
PARTICIPANTS


Patients were eligible if they were aged ≥ 18 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset.
INTERVENTIONS


Patients were randomly allocated 20 mg of fluoxetine once per day or the matching placebo for 6 months via a web-based system using a minimisation algorithm.
MAIN OUTCOME MEASURES


The primary outcome was the modified Rankin Scale at 6 months. Patients, carers, health-care staff and the trial team were masked to treatment allocation. Outcome was assessed at 6 and 12 months after randomisation. Patients were analysed by their treatment allocation as specified in a published statistical analysis plan.
RESULTS


Between 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated fluoxetine and 1563 of whom were allocated placebo. The modified Rankin Scale score at 6 months was available for 1553 out of 1564 (99.3%) of those allocated fluoxetine and 1553 out of 1563 (99.4%) of those allocated placebo. The distribution across modified Rankin Scale categories at 6 months was similar in the two groups (common odds ratio adjusted for minimisation variables 0.951, 95% confidence interval 0.839 to 1.079;  p  = 0.439). Compared with placebo, patients who were allocated fluoxetine were less likely to develop a new episode of depression by 6 months [210 (13.0%) vs. 269 (16.9%), difference -3.78%, 95% confidence interval -1.26% to -6.30%;  p  = 0.003], but had more bone fractures [45 (2.9%) vs. 23 (1.5%), difference 1.41%, 95% confidence interval 0.38% to 2.43%;  p  = 0.007]. There were no statistically significant differences in any other recorded events at 6 or 12 months. Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
LIMITATIONS


Some non-adherence to trial medication, lack of face-to-face assessment of neurological status at follow-up and lack of formal psychiatric diagnosis during follow-up.
CONCLUSIONS


20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients' functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients' characteristics and health-care setting.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN83290762.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 22. See the NIHR Journals Library website for further project information. The Stroke Association (reference TSA 2011101) funded the start-up phase.",2020,"Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
","['Patients were eligible if they were aged ≥\u200918 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset', 'patients after acute stroke', 'Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020', '103 UK hospitals', 'Between 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated']","['fluoxetine once per day or the matching placebo', 'FluoxetINe', 'Fluoxetine Or Control', 'fluoxetine', 'Fluoxetine', 'placebo']","['occurrence of depression', 'new episode of depression', 'modified Rankin Scale', 'bone fractures', 'risk of fractures', ""patients' functional outcome"", 'modified Rankin Scale score', 'functional recovery', 'functional outcomes', 'health-related quality of life, hospital bed usage or health-care costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",,0.352849,"Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Edinburgh Clinical Research Facility, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'House', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sandercock', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24220']
2223,32452429,Autonomy support and reduced feedback frequency have trivial effects on learning and performance of a golf putting task.,"Optimizing Performance Through Intrinsic Motivation and Attention for Learning (OPTIMAL) Theory proposes that choices of any kind support an individual's need for autonomy, motivating them to learn and perform motor skills more effectively. Notably, the authors suggest asking learners to choose when to receive feedback in order to increase autonomy. Conversely, the guidance hypothesis predicts an impact of feedback schedule independent of motivational influences. The purpose of this experiment was to compare the relative and combined effects of autonomy and feedback schedule for the acquisition of a golf putting task without vision of results. Autonomy support (autonomy support vs. yoked) and knowledge of results (KR) schedule (100%-KR vs. 50%-faded-KR) were combined in a 2 × 2 factorial design. Participants (N = 56) in the autonomy support groups were asked to choose from three colours of golf balls for each putt during 10 acquisition blocks. Yoked groups were yoked to the golf ball colour choices of their autonomy support group counterparts. Participants in the 100%-feedback schedule groups were provided x- and y-coordinate KR following every putt during acquisition, while participants in the 50%-faded groups received KR after half of their putts, with feedback frequency decreasing over acquisition blocks. All participants completed a 24-h delayed retention and transfer test without KR. The results were somewhat consistent with OPTIMAL Theory yet the effects were not statistically significant and trivially small. The results were inconsistent with the guidance hypothesis.",2020,The results were somewhat consistent with OPTIMAL Theory yet the effects were not statistically significant and trivially small.,['Participants in the 100%-feedback schedule groups were provided x'],"['Intrinsic Motivation and Attention for Learning (OPTIMAL', 'Autonomy support (autonomy support vs. yoked) and knowledge of results (KR) schedule (100%-KR vs. 50%-faded-KR']",['24-h delayed retention and transfer test without KR'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0022754', 'cui_str': 'Knowledge of Results (Psychology)'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022754', 'cui_str': 'Knowledge of Results (Psychology)'}]",,0.0349776,The results were somewhat consistent with OPTIMAL Theory yet the effects were not statistically significant and trivially small.,"[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'McKay', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1N 6N5, Canada. Electronic address: bmcka011@uottawa.ca.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Ste-Marie', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1N 6N5, Canada.'}]",Human movement science,['10.1016/j.humov.2020.102612']
2224,32452439,Beyond visual fixations and gaze behaviour. Using pupillometry to examine the mechanisms in the planning and motor performance of a golf putt.,"The present study assessed the potential value of using pupillometry to explore skill level differences in the allocation of attention during planning and performance of a golf putt across three putting conditions of varying complexity. Although numerous studies have reported on skill level differences in performers' visual search behaviours, performance accuracy and quiet eye duration (QE) across a range of performance settings, few have provided an objective measure of the allocation of attention during task performance. Fourteen participants were assigned to two groups [low handicap (LHG) and high handicap (HHG)] completing ten putts in three conditions; right to left (RL), left to right (LR) and straight (ST) from 1.75 m while wearing a mobile eye tracker. Skill based differences in the allocation of attention during green exploration and skill execution were observed. Pupil constriction observed for both groups during the QE period provides evidence of increased workload directly related to the increased motor task precision required in the physical performance of the putt. LHG had significantly more fixations of longer duration than their HHG counterparts. Distinct differences were also evident between skill levels in relation to number of fixations, fixation duration and QE duration on each putting condition. The significantly longer QE duration and larger pupil constrictions exhibited by skilled performers offer evidence of a distinctive concentration of cognitive activity characterised by highly automated processes.",2020,"Distinct differences were also evident between skill levels in relation to number of fixations, fixation duration and QE duration on each putting condition.",['Fourteen participants'],"['low handicap (LHG) and high handicap (HHG)] completing ten putts in three conditions; right to left (RL), left to right (LR) and straight (ST) from 1.75\xa0m while wearing a mobile eye tracker', 'LHG']","['number of fixations, fixation duration and QE duration', 'fixations of longer duration', 'QE duration', 'motor task precision', 'Pupil constriction']","[{'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0439757', 'cui_str': 'Left to right'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}]",14.0,0.171311,"Distinct differences were also evident between skill levels in relation to number of fixations, fixation duration and QE duration on each putting condition.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Carnegie', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk L39 4QP, UK. Electronic address: carnegie@edgehill.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marchant', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk L39 4QP, UK. Electronic address: Marchand@edgehill.ac.uk.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Towers', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk L39 4QP, UK. Electronic address: sam.towers@williamsbolton.co.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ellison', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk L39 4QP, UK. Electronic address: Ellisop@edgehill.ac.uk.'}]",Human movement science,['10.1016/j.humov.2020.102622']
2225,32452527,Author response to: Comment on: Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2020,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.112895,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maulat', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}]",The British journal of surgery,['10.1002/bjs.11699']
2226,32452528,Comment on: Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2020,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.146591,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Akbulut', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Sahin', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}]",The British journal of surgery,['10.1002/bjs.11700']
2227,32452549,Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.,"BACKGROUND


Lanadelumab demonstrated efficacy in preventing HAE attacks in the phase 3 HELP Study.
OBJECTIVE


To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
METHODS


Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t-test for continuous endpoints or Kappa statistics for categorical endpoints.
RESULTS


125 patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001). More patients receiving lanadelumab versus placebo were attack free (37.9-48.1% vs 7.3%) and responders (85.7-100% vs. 26.8%). During steady state, the efficacy of lanadelumab versus placebo was similar or improved versus days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower versus placebo, from the first 2 weeks of treatment through study end. TEAEs were comparable during days 0-69 and 70-182.
CONCLUSION


Protection with lanadelumab started from the first dose and continued throughout the entire study period.",2020,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","['125 patients', 'Eligible patients with HAE type I/II received']","['placebo', 'Lanadelumab', 'lanadelumab', 'lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo', 'lanadelumab versus placebo']","['durable-HAE attack rate', 'mean monthly attack rate', 'attacks requiring acute treatment', 'HAE attack rate', 'moderate/severe attacks', 'attack free']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",125.0,0.120587,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of California, San Diego, California, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati, Department of Internal Medicine, Division of Immunology/Allergy Section, Bernstein Clinical Research Center, Cincinnati, Ohio, USA.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust and University College London Hospitals, London, UK.""}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, P.C., Chevy Chase, Maryland, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Salomé', 'Initials': 'S', 'LastName': 'Juethner', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy and Asthma Research Associates, Dallas, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14416']
2228,32452561,Randomised clinical trial: Standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding.,"BACKGROUND


Early-transjugular intrahepatic porto-systemic shunt (TIPSS) has been recommended in international guidelines for high-risk patients with oesophageal variceal bleeding.
AIMS


To validate the results of a previous randomised control trial which supports use of early-TIPSS.
METHODS


In a two-centre open-label parallel-group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso-active drugs and endoscopic band ligation. Participants were randomised to standard of care or early-TIPSS. The primary outcome was 1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension.
RESULTS


Fifty-eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early-TIPSS group, a 1-year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early-TIPSS group (P = 0.09). Not all participants randomised to early-TIPSS received the intervention in time. For those receiving TIPSS per-protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
CONCLUSION


Early-TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high-risk patients with oesophageal variceal bleeding. Early-TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.",2020,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","['high-risk patients with oesophageal variceal bleeding', 'Fifty-eight patients (58\xa0±\xa011.12\xa0years; 32.7% female', 'patients with cirrhosis and acute variceal bleeding were recruited following', 'patients with cirrhosis and oesophageal variceal bleeding']","['transjugular intrahepatic porto-systemic shunt (TIPSS', 'standard of care or early-TIPSS', 'care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS', 'haemostasis with vaso-active drugs and endoscopic band ligation']","['Variceal rebleeding', 'rates of hepatic encephalopathy', 'Serious adverse events', 'survival', 'variceal rebleeding, increased encephalopathy', 'variceal rebleeding rates', '1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension', '1-year survival']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]",58.0,0.414712,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","[{'ForeName': 'Philip D J', 'Initials': 'PDJ', 'LastName': 'Dunne', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Ireland', 'Affiliation': 'Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15797']
2229,30821056,Intra-individual stability of NREM sleep quantitative EEG measures in obstructive sleep apnea.,"Electroencephalography is collected routinely during clinical polysomnography, but is often utilised to simply determine sleep time to calculate apnea-hypopnea indices. Quantitative analysis of these data (quantitative electroencephalogram) may provide trait-like information to predict patient vulnerability to sleepiness. Measurements of trait-like characteristics need to have high test-retest reliability. We aimed to investigate the intra-individual stability of slow-wave (delta power) and spindle frequency (sigma power) activity during non-rapid eye movement sleep in patients with obstructive sleep apnea. We recorded sleep electroencephalograms during two overnight polysomnographic recordings in 61 patients with obstructive sleep apnea (median days between studies 47, inter-quartile range 53). Electroencephalograms recorded at C3-M2 derivation were quantitatively analysed using power spectral analysis following artefact removal. Relative delta (0.5-4.5 Hz) and sigma (12-15 Hz) power during non-rapid eye movement sleep were calculated. Intra-class correlation coefficients and Bland-Altman plots were used to assess agreement between nights. Intra-class correlation coefficients demonstrated good-to-excellent agreement in the delta and sigma frequencies between nights (intra-class correlation coefficients: 0.84, 0.89, respectively). Bland-Altman analysis of delta power showed a mean difference close to zero (-0.4, 95% limits of agreement -9.4, 8.7) and no heteroscedasticity with increasing power. Sigma power demonstrated heteroscedasticity, with reduced stability as sigma power increased. The mean difference of sigma power between nights was close to zero (0.1, 95% limits -1.6, 1.8). We have demonstrated the stability of slow-wave and spindle frequency electroencephalograms during non-rapid eye movement sleep within patients with obstructive sleep apnea. The electroencephalogram profile during non-rapid eye movement sleep may be a useful biomarker for predicting vulnerability to daytime impairment in obstructive sleep apnea and responsiveness to treatment.",2019,Relative delta (0.5-4.5 Hz) and sigma (12-15 Hz) power during non-rapid eye movement sleep were calculated.,"['obstructive sleep apnea', 'patients with obstructive sleep apnea', '61 patients with obstructive sleep apnea (median days between studies 47, inter-quartile range 53']","['slow-wave (delta power) and spindle frequency (sigma power) activity during non-rapid eye movement sleep', 'NREM sleep quantitative EEG measures']",['mean difference of sigma power'],"[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}]",61.0,0.0227871,Relative delta (0.5-4.5 Hz) and sigma (12-15 Hz) power during non-rapid eye movement sleep were calculated.,"[{'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Poon', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Chapman', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Keith K H', 'Initials': 'KKH', 'LastName': 'Wong', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Mullins', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Cho', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jong W', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}]",Journal of sleep research,['10.1111/jsr.12838']
2230,30908263,Midair Haptic Pursuit.,"In human vision, smooth pursuit eye movement is the basic ability to visually follow a moving object by keeping it at the sight center. In this study, we validate that a human hand has a similar ability to track a midair haptic stimulus, i.e., a human palm exposed to a point vibration by a noncontact ultrasound tactile display can follow the continuous movement of the stimulation point. The experimental results show that the trackable velocity limit is 10 cm/s for motion parallel to the palm, when the initial velocity is zero. This ability of motion tracking by hand can be applied to haptic guidance for visually impaired people or for evacuation navigation, where no devices are needed to be equipped by users.",2019,"This ability of motion tracking by hand can be applied to haptic guidance for visually impaired people or for evacuation navigation, where no devices are needed to be equipped by users.",[],[],['Midair Haptic Pursuit'],[],[],[],,0.015045,"This ability of motion tracking by hand can be applied to haptic guidance for visually impaired people or for evacuation navigation, where no devices are needed to be equipped by users.","[{'ForeName': 'Azuma', 'Initials': 'A', 'LastName': 'Yoshimoto', 'Affiliation': ''}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': ''}, {'ForeName': 'Yasutoshi', 'Initials': 'Y', 'LastName': 'Makino', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shinoda', 'Affiliation': ''}]",IEEE transactions on haptics,['10.1109/TOH.2019.2906163']
2231,32442301,Adult cord blood transplant results in comparable overall survival and improved GRFS vs matched related transplant.,"We compared outcomes among adult matched related donor (MRD) patients undergoing peripheral blood stem cell transplantation and adult patients undergoing double unit cord blood transplantation (CBT) at our center between 2010 and 2017. A total of 190 CBT patients were compared with 123 MRD patients. Median follow-up was 896 days (range, 169-3350) among surviving CBT patients and 1262 days (range, 249-3327) among surviving MRD patients. Comparing all CBT with all MRD patients, overall survival (OS) was comparable (P = .61) and graft-versus-host disease (GVHD) relapse-free survival (GRFS) was significantly improved among CBT patients (P = .0056), primarily because of decreased moderate to severe chronic GVHD following CBT (P < .0001; hazard ratio [HR], 3.99; 95% confidence interval [CI], 2.26-7.04). Among patients undergoing our most commonly used MRD and umbilical cord blood (CB) myeloablative regimens, OS was comparable (P = .136) and GRFS was significantly improved among CBT patients (P = .006). Cumulative incidence of relapse trended toward decreased in the CBT group (P = .075; HR, 1.85; CI 0.94-3.67), whereas transplant-related mortality (TRM) was comparable (P = .55; HR, 0.75; CI, 0.29-1.95). Among patients undergoing our most commonly used nonmyeloablative regimens, OS and GRFS were comparable (P = .158 and P = .697). Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM). Our outcomes support the efficacy of CBT and suggest that among patients able to tolerate more intensive conditioning regimens at high risk for relapse, CB may be the preferred donor source.",2020,"Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM).","['190 CBT patients were compared with 123 MRD patients', 'adult matched related donor (MRD) patients undergoing peripheral blood stem cell transplantation and adult patients undergoing double unit cord blood transplantation (CBT) at our center between 2010 and 2017']",['CBT'],"['overall survival and improved GRFS', 'nonmyeloablative regimens, OS and GRFS', 'MRD and umbilical cord blood (CB) myeloablative regimens, OS', 'GRFS', 'Cumulative incidence of relapse', 'Cumulative incidence of both relapse and TRM', 'transplant-related mortality (TRM', 'overall survival (OS', 'graft-versus-host disease (GVHD) relapse-free survival (GRFS', 'severe chronic GVHD']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}]",190.0,0.0849146,"Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM).","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Enkhtsetseg', 'Initials': 'E', 'LastName': 'Purev', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Haverkos', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pollyea', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Cherry', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Forsberg', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sherbenou', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hammes', 'Affiliation': 'Center for Innovative Design and Analysis, Department of Biostatistics and Informatics, and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rabinovitch', 'Affiliation': 'Department of Radiation Oncology, University of Colorado, Aurora, CO.'}, {'ForeName': 'Clayton A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Gutman', 'Affiliation': 'Division of Hematology.'}]",Blood advances,['10.1182/bloodadvances.2020001554']
2232,32442353,A randomized controlled clinical trial comparing the use of displacement cords and aluminum chloride paste.,"OBJECTIVES


This clinical study measured the change in opening and height of the displaced gingiva using paste and cord retraction materials for definitive impression making of natural teeth and assessed if they were comparable and clinically acceptable.
METHODS


Impressions of 4 maxilla premolars from 10 participants were taken using a split-mouth protocol. All participants were free of periodontal disease, had a thick biotype, a minimal of 3 mm height of keratinized gingival tissue and gingival sulci depths of 2 mm. The bleeding index (BI), gingival index (GI) plaque index (PI), sulcular depth, level of attachment and tooth sensitivity were recorded at baseline, just after retraction, at 24 hours and at 2 weeks. Impressions were poured in stone and then after initial analysis were cross-sectioned to allow measurements of the gingival height change and gap size to be recorded.
RESULTS


The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively. Gingival height with the paste was 0.047 mm lower than that achieved by the cord (P = .208).
CONCLUSIONS


Cord and paste retraction produced comparable clinically acceptable gingival gaps, with the cord producing statistically larger gap size.
CLINICAL SIGNIFICANCE


The cord and paste retraction materials produced comparable clinically acceptable gingival retraction.",2020,"The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively.","['All participants were free of periodontal disease, had a thick biotype, a minimal of 3\u2009mm height of keratinized gingival tissue and gingival sulci depths of 2\u2009mm', 'Impressions of 4 maxilla premolars from 10 participants were taken using a split-mouth protocol']",['displacement cords and aluminum chloride paste'],"['bleeding index (BI), gingival index (GI) plaque index (PI), sulcular depth, level of attachment and tooth sensitivity', 'acceptable gingival retraction', 'Gingival height']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441707', 'cui_str': 'Biotyping'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0317562', 'cui_str': 'Eubacterium sulci'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",10.0,0.0760322,"The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bennani', 'Affiliation': 'Department of Oral Rehabilitation, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Aarts', 'Affiliation': 'Department of Oral Rehabilitation, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brunton', 'Affiliation': 'Pro Vice Chancellor Health Sciences, University of Otago, Dunedin, New Zealand.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12581']
2233,32443357,"A prospective observational study to explore the correlation of peripheral arterial pulse/resistance index, organ function, and inflammation in patients with septic shock.","INTRODUCTION


The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect. We aimed to design an observational study protocol to explore the correlation of peripheral arterial pulse/resistance index, organ function and inflammation in patients with septic shock.
METHODS AND ANALYSIS


A total of 60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled. Total of 60 patients with septic shock will be randomly divided into 20 groups by lot method. Group 1: fluid resuscitation; Group 2: fluid resuscitation + norepinephrine; Group 3: fluid resuscitation + norepinephrine + ulinastatin; Group 4: healthy control group. Fluid resuscitation is an early goal-directed fluid resuscitation in which norepinephrine is adjusted by a senior intensive care unit specialist for clinical presentation and ulinastatin is pumped at 20,000 U/h. Index including vascular ultrasound, inflammatory factors, organ function will be collected and analyzed.
DISCUSSION


Existing studies on septic shock focus on hemodynamics of the heart, brain, and kidney, while the differences in blood flow between peripheral blood vessels and protective renal vessels may be consistent, and imaging analysis is still lacking. This study protocol aims to explore the correlation of peripheral arterial pulsation index/resistance index, organ function, and inflammation in patients with septic shock.
TRIAL REGISTRATION


Chinese Clinical trial registry: ChiCTR2000031565.",2020,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","['patients with septic shock', '60 patients with septic shock', '60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled']","['Fluid resuscitation', 'fluid resuscitation; Group 2: fluid resuscitation\u200a+\u200anorepinephrine; Group 3: fluid resuscitation\u200a+\u200anorepinephrine\u200a+\u200aulinastatin; Group 4: healthy control group']","['peripheral arterial pulse/resistance index, organ function and inflammation', 'peripheral arterial pulse/resistance index, organ function, and inflammation', 'peripheral arterial pulsation index/resistance index, organ function, and inflammation', 'Index including vascular ultrasound, inflammatory factors, organ function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0948543', 'cui_str': 'Vascular ultrasound'}]",60.0,0.138439,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","[{'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University.'}, {'ForeName': 'Changxue', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Care, Luzhou Maternal and Child Health Hospital, Luzhou, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000020235']
2234,32443364,Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial.,"INTRODUCTION


Rehabilitation after anterior cruciate ligament (ACL) reconstruction is critical to patient outcome. Despite its importance; however, hospital-based rehabilitation is limited, with barriers, including distance and cost. With recent technological advancements, wearable devices have actively been used to address these barriers. In this study, we propose a randomized controlled trial protocol investigating the efficacy and feasibility of home-based rehabilitation after ACL reconstruction using a smart wearable device providing electrical stimulation that allows knee exercise.
METHODS AND ANALYSIS


This is a protocol proposal for a prospective, single-center, randomized, controlled study. We plan to recruit adults discharged after ACL reconstruction; the recruited subjects will be randomly allocated to 1 of 2 groups, using a computer-generated randomization method: the intervention (n = 20) or control group (n = 20). The intervention group will receive a 6-week home-based rehabilitation program using smart wearable device. The control group will undergo a 6-week self-exercise program as normal. The following outcomes will be assessed at baseline, 2 weeks, and 6 weeks post the 6-week intervention program: quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain. An intention-to-treat analysis will be conducted for the primary outcome.
DISCUSSION


This study is a prospective, single-center, randomized, controlled study. This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device. The findings of this study will help to establish a home-based rehabilitation program to better recovery in patients with ACL reconstruction.
TRIAL REGISTRATION NUMBER


This protocol was registered in ClinicalTrials.gov, under the number NCT04079205.",2020,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","['patients after ACL reconstruction using a smart wearable device', 'adults discharged after ACL reconstruction; the recruited subjects', 'anterior cruciate ligament reconstruction', 'patients with ACL reconstruction']","['home-based rehabilitation after ACL reconstruction', '6-week self-exercise program', '6-week home-based rehabilitation program using smart wearable device', 'Rehabilitation after anterior cruciate ligament (ACL) reconstruction', 'Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation', 'structured home-based rehabilitation program']","[""quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",,0.103089,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","[{'ForeName': 'Gowun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'EXOSYSTEMS Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}]",Medicine,['10.1097/MD.0000000000020256']
2235,32443379,An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS).,"INTRODUCTION


Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level.
METHODS/DESIGN


An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156).
DISCUSSION


This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov NCT04330872 registered on April 2, 2020.",2020,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"['patients with newly diagnosed ischemic stroke (ECASIS', 'Patients with newly diagnosed ischemic stroke who are just about to start', 'Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar', 'diabetic patients', 'patients with newly diagnosed ischemic stroke']","['enteric-coated (EC) aspirin', 'TXB2', 'Aspirin', 'aspirin', 'EC aspirin or plain Aspirin', 'EC Aspirin and plain Aspirin']","['Thromboxane A2 (TXA 2) levels', 'Thromboxane B2 (TXB2) level', 'incidence of aspirin non-responders (level of residual serum', 'elevated thrombotic risk', 'incidence of GIT bleeding of various preparations of Aspirin', 'Thromboxane B2 level', 'tolerability and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0040057', 'cui_str': 'Thromboxane A>2<'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.103097,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"[{'ForeName': 'Mohamed Nabil', 'Initials': 'MN', 'LastName': 'Elshafei', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Yahia', 'Initials': 'Y', 'LastName': 'Imam', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Arwa Ebrahim', 'Initials': 'AE', 'LastName': 'AlSaud', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'Ahmed', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Khaldun', 'Initials': 'K', 'LastName': 'Obeidat', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Razan', 'Initials': 'R', 'LastName': 'Saeid', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Ibtihal M', 'Initials': 'IM', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Aeijaz Sultan', 'Initials': 'AS', 'LastName': 'Parray', 'Affiliation': 'Interim-Lab, Hamad Medical City, Hamad Medical Corporation.'}, {'ForeName': 'Mohammed Ibn-Masoud', 'Initials': 'MI', 'LastName': 'Danjuma', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}]",Medicine,['10.1097/MD.0000000000020307']
2236,32443390,Effects of virtual reality immersive training with computerized cognitive training on cognitive function and activities of daily living performance in patients with acute stage stroke: A preliminary randomized controlled trial: Retraction.,,2020,,['patients with acute stage stroke'],['virtual reality immersive training with computerized cognitive training'],['cognitive function and activities of daily living performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.160731,,[],Medicine,['10.1097/MD.0000000000020598']
2237,32444041,The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin levels; A double-blind randomized clinical trial.,"OBJECTIVES


Jaundice is a typical condition in the neonatal period, particularly in the Asian continent. Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation are the results of impairment in controlling it. The increase in oxidant substances can stimulate the heme oxygenase enzyme and increase the conversion of heme to bilirubin. In some studies, vitamin C levels in the blood of infants with hyperbilirubinemia were lower than in healthy infants.
DESIGN


In this double-blind clinical trial study, 144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation were randomly divided into intervention, and control groups and until the end of pregnancy, they took a 500 mg tablet of vitamin C or placebo (Preparation of starch) daily. Demographic information, dietary intake, and physical activity level of the participants were also evaluated. The total blood bilirubin level was measured on the fifth day after birth using a sample of the neonatal heel. Statistical analysis was performed using SPSS software version 22. In this study P-value < 0. 05 was considered significant.
RESULTS


Of the 144 participants, 128 of them completed the intervention. There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
CONCLUSION


Vitamin C supplementation in the last month of pregnancy had a significant effect on neonatal bilirubin level and decreased it significantly.",2020,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","['144 participants', '144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation']","['vitamin C or placebo (Preparation of starch) daily', 'Vitamin C supplementation', 'vitamin C supplementation']","['Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation', 'total blood bilirubin level', 'neonatal bilirubin level', 'Demographic information, dietary intake, and physical activity level', 'vitamin C levels', 'neonatal bilirubin levels', 'conversion of heme to bilirubin', 'level of vitamin C intake through diet, and anthropometric indices', 'oxidant substances', 'total bilirubin level']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0020796', 'cui_str': 'Profound intellectual disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0564420', 'cui_str': 'Vitamin C intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}]",144.0,0.122377,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khadem Al-Hosseini', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Rahideh', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saadati', 'Affiliation': 'Pediatric Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rahmati', 'Affiliation': 'Department of Obstetrics and Gynecology, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Azadeh', 'Affiliation': 'Health Deputy, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102359']
2238,32444045,The effect of the Mediterranean diet on cognitive function in patients with Parkinson's disease: A randomized clinical controlled trial.,"OBJECTIVES


Parkinson's disease (PD) is the second most common neurodegenerative disorder. It is proposed that adherence to the Mediterranean diet might have a beneficial effect on the prevention and treatment of PD and its complications. Thus, the aim of this study was to investigate the effects of the Mediterranean diet on cognitive function in patients with PD.
DESIGN


The study was a single-center, randomized clinical trial. Eighty patients with idiopathic PD were randomly allocated to the Mediterranean diet (n = 40) or control (n = 40) group. Patients in the intervention group received an individualized dietary plan based on Mediterranean diet for 10 weeks. The Persian version of Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive function at baseline and the end of the study.
RESULTS


Thirty-five PD patients with a mean age of 59.3 ± 8.3 and 35 patients with a mean age of 58.6 ± 9.3 finished the study in intervention and control groups, respectively. After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all). Nevertheless, the mean of the other scores including spatial-visual ability, memory learning task, and navigation versus time and place did not significantly change in both intervention and control groups.
CONCLUSIONS


The findings of this study showed that adherence to the Mediterranean diet remarkably increased the dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment in PD patients.",2020,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[""patients with Parkinson's disease"", 'Eighty patients with idiopathic PD', 'patients with PD', ""Parkinson's disease (PD"", 'Thirty-five PD patients with a mean age of 59.3\u202f±\u202f8.3 and 35 patients with a mean age of 58.6\u202f±']","['individualized dietary plan based on Mediterranean diet', 'Mediterranean diet']","['Persian version of Montreal Cognitive Assessment (MoCA) test', 'cognitive function', 'dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment', 'mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment', 'spatial-visual ability, memory learning task, and navigation versus time and place']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",80.0,0.0280924,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[{'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: paknahad@hlth.mui.ac.ir.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sheklabadi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Yeganeh', 'Initials': 'Y', 'LastName': 'Derakhshan', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Chitsaz', 'Affiliation': 'Professor of Neurology Isfahan University of Medical Sciences, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102366']
2239,32444056,"The effects of licorice containing diphenhydramine solution on recurrent aphthous stomatitis: A double-blind, randomized clinical trial.","OBJECTIVES


The aim of this study was to compare the efficacy of the diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG) in the treatment of recurrent aphthous stomatitis (RAS).
DESIGN


It was a double-blind randomized clinical trial that was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran.
INTERVENTION


DSG was made by adding 5% hydroethanolic extract of licorice to the diphenhydramine elixir. A total of 70 patients diagnosed with RSA were randomly assigned to the DS and DSG groups, each containing 35 patients. Participants were instructed to swish 3 ml of either solution around their mouth for about three minutes four times a day (at least 20 min before each meal and before bedtime) until the complete healing of the oral lesions.
MAIN OUTCOME MEASURES


The primary outcome of this study was to assess the severity of pain prior to the intervention and on the first, third, and fifth days of it. This was done using the visual analog scale (VAS). The duration of wound healing was also measured through photography. The secondary outcome was to record the adverse effects of the intervention. This trial was registered at the Iranian Registry of Clinical Trials under number 1  IRCT20180407039213N1.
RESULTS


The average pain score before the treatment in the DS and DSG groups was 8. 1 ± 1.17 and 7.97 ± 1.72, respectively, and there was apparently no significant difference between them. However, there was a significant difference between the two groups in terms of the average pain scores on the first (7 ± 1.28 versus 5.31 ± 1.28), third (4.02 ± 1.8 vs. 2.86 ± 1.56) and fifth days (1.71 ± 1.69 vs. 0.54 ± 1.31) of the intervention. Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001). No adverse effects were observed with the intervention.
CONCLUSION


According to our results, DSG appeared to be more effective in treating RAS than DS alone.
TRIAL REGISTRATION


The trial was registered at Iranian Registry of Clinical Trials before the enrolment of the first patient on June 29, 2019 (registration no: IRCT20180407039213N1, http://www.irct.ir/trial/31497).",2020,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","['was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran', 'recurrent aphthous stomatitis (RAS', '70 patients diagnosed with RSA']","['licorice containing diphenhydramine solution', 'diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG', 'DS and DSG']","['visual analog scale (VAS', 'severity of pain prior to the intervention and on the first, third, and fifth days of it', 'average wound healing duration', 'recurrent aphthous stomatitis', 'average pain score', 'average pain scores', 'duration of wound healing', 'adverse effects']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",70.0,0.19952,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: narges.akbare4021@yahoo.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Asadimehr', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: n.asadi137339@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiani', 'Affiliation': 'Pharmacology Department, Medical School, Birjand University of Medical Sciences, Birjand, 9717853577, Iran. Electronic address: kiani.za@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102401']
2240,32444057,Effects of a short-term mindfulness-based stress reduction program on the quality of life of women with infertility: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


Although some programs based on mindfulness-based stress reduction (MBSR) have been suggested to promote quality of life (QoL) in different conditions, limited studies have addressed their potential effects in women with infertility. In this study, we aimed to determine the effects of an MBSR program on the QoL of women with infertility.
MATERIALS AND METHODS


This randomized controlled clinical trial was conducted on 36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran. Women either participated in the MBSR program or received routine consultation in eight two-hour group sessions once a week. Women's QoL was measured using the 36-item short-form health survey before, immediately after, and one month after the intervention. The intention-to-treat analysis, with multiple imputation for missing data, was also performed.
RESULTS


The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases). Twenty four and six adverse events were recorded in the experimental and control groups, respectively.
CONCLUSION


Short-term MBSR program seem to be potentially effective in improving the QoL of women with infertility. Further studies are needed to determine the generalizability of our findings.",2020,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","['women with infertility', '36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran', 'Women either participated in the MBSR program or received']","['MBSR program', 'short-term mindfulness-based stress reduction program', 'routine consultation']","['quality of life', 'total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",36.0,0.0481449,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","[{'ForeName': 'Masoumeh Sadat', 'Initials': 'MS', 'LastName': 'Hosseini', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Masoumehsadat.hosseini@yahoo.com.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Mousavi', 'Affiliation': 'Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Mousavip2009@yahoo.com.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Hekmat', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Hekmat1346@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Johari Fard', 'Affiliation': 'Department of Psychology, Islamic Azad University, Ahvaz Branch, Ahvaz, Iran. Electronic address: Rjoharifard@gmail.com.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mohammad Jafari', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Rmj41@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102403']
2241,31626688,"Erratum to: Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.",,2020,,['Community-acquired Bacterial Pneumonia'],"['Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic']",[],"[{'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0071283', 'cui_str': 'Pleuromutilin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],,0.017979,,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saviski', 'Affiliation': ''}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': ''}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Seltzer', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Paukner', 'Affiliation': ''}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': ''}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'Leanne B', 'Initials': 'LB', 'LastName': 'Gasink', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz710']
2242,32445738,"Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial.","BACKGROUND


People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec.
METHODS


In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete.
FINDINGS


Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events).
INTERPRETATION


A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial.
FUNDING


Novo Nordisk.",2020,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","['People with type 1 diabetes who use', '24 participants who completed both study phases', '43 patients for eligibility, of whom 31', 'LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII', 'physically active adults with type 1 diabetes (FIT Untethered', 'adults with type 1 diabetes who exercise regularly']","['Flexible insulin therapy', 'injected insulin degludec and CSII (with pump removal during exercise', 'usual CSII regimen (n=14) or hybrid CSII regimen', 'continuous subcutaneous insulin infusion (CSII, or insulin pump therapy', 'insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise']","['longer time in blood glucose range', 'higher time in blood glucose range', 'time spent in hypoglycaemia, nor the number of hypoglycaemic events', 'efficacy and safety', '1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose', 'time spent in hyperglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",43.0,0.0906429,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","[{'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada. Electronic address: ronnie.aronson@lmc.ca.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGaugh', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30114-5']
2243,32445969,How do oncoming traffic and cyclist lane position influence cyclist overtaking by drivers?,"Overtaking cyclists is challenging for drivers because it requires a well-timed, safe interaction between the driver, the cyclist, and the oncoming traffic. Previous research has investigated this manoeuvre in different experimental environments, including naturalistic driving, naturalistic cycling, and simulator studies. These studies highlight the significance of oncoming traffic-but did not extensively examine the influence of the cyclist's position within the lane. In this study, we performed a test-track experiment to investigate how oncoming traffic and position of the cyclist within the lane influence overtaking. Participants overtook a robot cyclist, which was controlled to ride in two different lateral positions within the lane. At the same time, an oncoming robot vehicle was controlled to meet the participant's vehicle with either 6 or 9 s time-to-collision. The order of scenarios was randomised over participants. We analysed safety metrics for the four different overtaking phases, reflecting drivers' safety margins to rear-end, head-on, and side-swipe collisions, in order to investigate the two binary factors: 1) time gap between ego vehicle and oncoming vehicle, and 2) cyclist lateral position. Finally, the effects of these two factors on the safety metrics and the overtaking strategy (either flying or accelerative depending on whether the overtaking happened before or after the oncoming vehicle had passed) were analysed. The results showed that, both when the cyclist rode closer to the centre of the lane and when the time gap to the oncoming vehicle was shorter, safety margins for all potential collisions decreased. Under these conditions, drivers-particularly female drivers-preferred accelerative over flying manoeuvres. Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.",2020,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,[],[],[],[],[],[],,0.0264438,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rasch', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: alexander.rasch@chalmers.se.'}, {'ForeName': 'Christian-Nils', 'Initials': 'CN', 'LastName': 'Boda', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: christian-nils.boda@chalmers.se.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Thalya', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden; Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: prateek.thalya@veoneer.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Aderum', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: tobias.aderum@veoneer.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Knauss', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: alessia.knauss@veoneer.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Dozza', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: marco.dozza@chalmers.se.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105569']
2244,32449296,Short-term neurophysiological effects of sensory pathway neurorehabilitation strategies on chronic poststroke oropharyngeal dysphagia.,"BACKGROUND


Neurorehabilitation strategies for chronic poststroke (PS) oropharyngeal dysphagia (OD) have been mainly focused on the neurostimulation of the pharyngeal motor cortex with only marginal effects. In contrast, treatments targeting the PS oropharyngeal sensory pathway dysfunction offer very promising results, but there is little knowledge on the underlying mechanisms. We aimed to explore the neurophysiological mechanisms behind the effect of three sensory neurostimulation strategies.
METHODS


We carried out a randomized two-blinded parallel group's crossover sham-controlled clinical trial in 36 patients with unilateral stroke and chronic unsafe swallow to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C). The effect was evaluated immediately after the interventions with videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP).
KEY RESULTS


Interventions induced no changes in the biomechanics of the swallow response during VFS. However, an enhancement of motor cortex excitability (latency shortening and increased size of thenar MEP) was found with active interventions (A + B + C, and B/C alone; P < .05 for all) but not with sham. Active but not sham interventions shortened pharyngeal SEP latency in the ipsilesional hemisphere (A + B + C: P2-peak, P = .039; A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
CONCLUSIONS AND INFERENCES


Sensory pathway neurostimulation strategies caused immediate enhancement of motor cortex excitability with peripheral strategies (capsaicin and IPES) and of pharyngeal sensory conduction with rTMS. These changes support the use of sensory neurorehabilitation strategies in promoting swallow recovery in chronic PS-OD.",2020,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","['chronic poststroke (PS) oropharyngeal dysphagia (OD', '36 patients with unilateral stroke and chronic unsafe swallow']","['videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP', 'sensory pathway neurorehabilitation strategies', 'sensory neurorehabilitation strategies', 'repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C']","['motor cortex excitability (latency shortening and increased size of thenar MEP', 'biomechanics of the swallow response', 'chronic poststroke oropharyngeal dysphagia', 'pharyngeal SEP latency']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0230374', 'cui_str': 'Thenar region structure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}]",36.0,0.0786383,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabib', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Weslania', 'Initials': 'W', 'LastName': 'Nascimento', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Rofes', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Arreola', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Tomsen', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mundet', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Palomeras', 'Affiliation': 'Neurology Department, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Technological Educational Institute Western Greece, Patras, Greece.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ortega', 'Affiliation': 'Gastrointestinal Physiology Laboratory. Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13887']
2245,32449335,Could intraoperative magnesium sulphate protect against postoperative cognitive dysfunction?,"BACKGROUND


Although there is much concern about the pathogenesis of postoperative cognitive dysfunction (POCD); no effective prevention strategies are currently described. The aim of this work was to study whether intraoperative magnesium sulphate could have a protective effect against developing POCD and to study its impact on serum level of S100B; a marker of neuronal degeneration.
METHODS


This is a prospective randomized controlled trial carried out on 80 participants undergoing elective laparoscopic cholecystectomy, 40 participants received conventional general anaesthesia (conventional anaesthesia group) and 40 participants received conventional general anaesthesia with extra administration of intraoperative magnesium sulphate (Mg sulphate group). Cognitive assessment for both groups was done preoperatively and 1 week postoperatively using Paired Associate Learning test (PALT) and Benton Visual Retention test (BVRT). Quantitative determination of serum S100B was done for both groups preoperatively and 1 week postoperatively by using an enzyme- linked immunoabsorbent assay technique.
RESULTS


Postoperative PALT and BVRT were significantly lower than preoperative PALT and BVRT in the conventional anaesthesia group (P-value = 0.043, P-value = 0.015 respectively), but not in the Mg sulphate group (P-value = 0.134, P-value = 0.151 respectively). Postoperative S100B was significantly higher than preoperative S100B in the conventional anaesthesia group (P-value = 0.006), but not in the Mg sulphate group (P-value = 0.293).
CONCLUSIONS


Administration of intravenous infusion of magnesium sulphate during conventional general anaesthesia can protect against POCD and attenuate the post operative elevation of serum S100B.",2020,"RESULTS


Postoperative PALT and BVRT were significantly lower than preoperative PALT and","['80 participants undergoing elective laparoscopic cholecystectomy, 40 participants received']","['intraoperative magnesium sulphate', 'magnesium sulphate', 'conventional general anaesthesia (conventional anaesthesia group) and 40 participants received conventional general anaesthesia with extra administration of intraoperative magnesium sulphate (Mg sulphate group', 'Mg sulphate']","['BVRT', 'Cognitive assessment', 'Paired Associate Learning test (PALT) and Benton Visual Retention test (BVRT', 'Postoperative S100B', 'Postoperative PALT and BVRT']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}]","[{'cui': 'C2143012', 'cui_str': 'Benton visual retention test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.0426632,"RESULTS


Postoperative PALT and BVRT were significantly lower than preoperative PALT and","[{'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hassan', 'Affiliation': 'Department of Anaesthesia, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mona H', 'Initials': 'MH', 'LastName': 'Tawfik', 'Affiliation': 'Department of Neurology, Beni-Suef University, Beni-Suef, Egypt - mona.neuro@yahoo.com.'}, {'ForeName': 'Tamer M', 'Initials': 'TM', 'LastName': 'Nabil', 'Affiliation': 'General Surgery, Department of General Surgery, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Rehab M', 'Initials': 'RM', 'LastName': 'Abd Elkareem', 'Affiliation': 'Clinical and Chemical Pathology, Department of Clinical and Chemical Pathology, Beni-Suef University, Beni-Suef, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14012-4']
2246,32449336,Comparison between the ultrasound-guided erector spinae block and the subcostal approach to the transversus abdominis plane block in obese patients undergoing sleeve gastrectomy; a randomized controlled trial.,"BACKGROUND


Pain control in the morbidly obese has presented as an anesthetic challenge. The aim of this study is to assess the analgesic efficacy of ultrasound guided bilateral erector spinae block compared to bilateral subcostal transversus abdominis plane block.
METHODS


Prospective randomized, double-blinded controlled study was conducted at Kasr Alainy Hospital on 66 patients scheduled for laparoscopic sleeve gastrectomy. Patients were randomly allocated into three groups and received general anesthesia: bilateral erector spinae block at the level of T9 or bilateral subcostal transversus abdominis block or opioid analgesia (control group). The primary outcome was pain assessment by of Visual Analogue Scale.
RESULTS


Visual Analogue Scale were lower in the Erector spinae and Transversus abdominis groups compared with the control group throughout the first 12 postoperative hours (p=<0.001). Visual analogue score was lower in Erector spinae group in relation to control group at 18th postoperative hour (P=0.034). Visual analogue scores in the Erector spinae group were significantly lower compared to Transversus abdominis at the 12 postoperative hours. 24hours postoperative pethidine consumption was higher in the control group (median 150 and IQR 100-200) compared to both erector spinae (median 0 and IQR 0-50) and transversus abdominis (median 50 and IQR 0-100) groups (p-value <0.001). Erector spinae group showed less pethidine consumption than transversus abdominis group.
CONCLUSIONS


Ultrasound-guided single-shot T9 erector spinae plane block lowers postoperative pain scores, and reduces intraoperative and postoperative opioid consumption compared with both the subcostal approach transversus abdominis plane block and the control group in obese patients that had undergone sleeve gastrectomy.",2020,24hours postoperative pethidine consumption was higher in the control group (median 150 and IQR 100-200) compared to both erector spinae (median 0 and IQR 0-50) and transversus abdominis (median 50 and IQR 0-100) groups (p-value <0.001).,"['obese patients that had undergone sleeve gastrectomy', 'obese patients undergoing', '66 patients scheduled for']","['laparoscopic sleeve gastrectomy', 'general anesthesia: bilateral erector spinae block at the level of T9 or bilateral subcostal transversus abdominis block or opioid analgesia (control group', 'ultrasound-guided erector spinae block and the subcostal approach to the transversus abdominis plane block', 'sleeve gastrectomy', 'ultrasound guided bilateral erector spinae block']","['pain assessment by of Visual Analogue Scale', '24hours postoperative pethidine consumption', 'intraoperative and postoperative opioid consumption', 'postoperative pain scores', 'Visual Analogue Scale', 'analgesic efficacy', 'Visual analogue score', 'pethidine consumption', 'Visual analogue scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",66.0,0.160298,24hours postoperative pethidine consumption was higher in the control group (median 150 and IQR 100-200) compared to both erector spinae (median 0 and IQR 0-50) and transversus abdominis (median 50 and IQR 0-100) groups (p-value <0.001).,"[{'ForeName': 'Bassant M', 'Initials': 'BM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Anesthesiology, Pain Management and Surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt - bassantmohamed197@yahoo.com.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Khaled', 'Affiliation': 'Department of Anesthesiology, Pain Management and Surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesiology, Pain Management and Surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Hassan', 'Affiliation': 'Department of Anesthesiology, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14064-1']
2247,32449365,"""When I receive the message, it is a sign of love"": symbolic connotations of SMS messages for people living with HIV in Burkina Faso.","Mobile health (mHealth) has gained considerable interest recently due to its potential to improve health outcomes in developing countries with high outreach yet low costs. Several studies have explored the use of short message service (SMS) reminders to improve antiretroviral (ARV) retention and adherence, with mixed results. The majority of these studies has a quantitative nature and employs randomized designs, which do not provide further qualitative insights about other possible impacts of the messages. Based on the qualitative assessment of an SMS intervention in Burkina Faso, which complemented a (quantitative) Randomized Controlled Trial (RCT), we show that beyond the functional role of improving ARV retention and adherence, SMS messages can also play important symbolic roles in offering psychosocial support to people living with HIV (PLHIV) and improving their perception of life. Concomitantly, we show that sufficient (ICT) literacy skills cannot be taken for granted in resource-poor settings. Yet, regardless of (ICT) literacy skills, the symbolism of care was perceived. Furthermore, we highlight the importance of complementing quantitative evidence of mHealth interventions with qualitative assessments.",2020,Mobile health (mHealth) has gained considerable interest recently due to its potential to improve health outcomes in developing countries with high outreach yet low costs.,['people living with HIV in Burkina Faso'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]",[],[],,0.0784269,Mobile health (mHealth) has gained considerable interest recently due to its potential to improve health outcomes in developing countries with high outreach yet low costs.,"[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Geldof', 'Affiliation': 'International Institute of Social Studies, Erasmus University Rotterdam, The Hague, The Netherlands.'}, {'ForeName': 'Boundia Alexandre', 'Initials': 'BA', 'LastName': 'Thiombiano', 'Affiliation': 'Institut du Développement Rural (IDR), Université Nazi Boni (former Université Polytechnique de Bobo-Dioulasso), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Natascha', 'Initials': 'N', 'LastName': 'Wagner', 'Affiliation': 'International Institute of Social Studies, Erasmus University Rotterdam, The Hague, The Netherlands.'}]",AIDS care,['10.1080/09540121.2020.1769832']
2248,32449396,Taking Care of Yourself and Your Risk for Breast Cancer (CUIDARSE): A Randomized Controlled Trial of a Health Communication Intervention for Latinas.,"Latinas in the United States are more likely to be diagnosed with late-stage breast cancer (BC) compared to non-Latinas. Literacy-appropriate and culturally sensitive cancer communication interventions can help address existing racial/ethnic BC disparities. We formatively developed a new BC prevention brochure for Spanish-speaking Latinas (≥35 years). Eligible women ( n  = 240) from a large public hospital in California were randomly assigned to one of three study arms: Group 1 received the new brochure, Group 2 included a community health worker (CHW) who delivered the new brochure's content, and a control group received a standard educational brochure. Participants completed three surveys (baseline, postintervention, 3-month follow-up) with a 100% completion rate for the first two surveys and 80.4% completion after 3 months. We assessed the difference in outcomes for BC risk knowledge, perceived BC susceptibility, and BC information self-efficacy between groups. Participant mean age was 52.3 years, and 82.1% reported low English proficiency. Mean knowledge scores increased and perceived BC susceptibility improved for all groups ( p  ≤ .05), yet treatment effects were not significant between groups for these outcomes. BC information self-efficacy also increased from baseline to postintervention for all groups to >80%. After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models. A CHW-delivered intervention may be more effective in improving BC information self-efficacy among Latinas compared to print material alone. More research is needed to examine the efficacy of CHW-delivered interventions.",2020,"After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models.","['Spanish-speaking Latinas (≥35 years', 'Eligible women ( n  = 240) from a large public hospital in California', 'Breast Cancer (CUIDARSE', 'Latinas', 'Participant mean age was 52.3 years, and 82.1% reported low English proficiency']","['Health Communication Intervention', 'Literacy-appropriate and culturally sensitive cancer communication interventions', ""new brochure, Group 2 included a community health worker (CHW) who delivered the new brochure's content, and a control group received a standard educational brochure""]","['BC susceptibility', 'BC risk knowledge, perceived BC susceptibility, and BC information self-efficacy', 'Mean knowledge scores', 'BC information self-efficacy']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C1512347', 'cui_str': 'Health Communication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.069156,"After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models.","[{'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Payán', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Maggard-Gibbons', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Flórez', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, CA, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mejía', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Hemmelgarn', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kanouse', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Kahn', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Golinelli', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Diaz Fuentes', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Sydne J', 'Initials': 'SJ', 'LastName': 'Newberry', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Marielena', 'Initials': 'M', 'LastName': 'Lara', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120920529']
2249,32458831,Anodal tDCS Over the Left Prefrontal Cortex Does Not Cause Clinically Significant Changes in Circulating Metabolites.,"Background


Transcranial direct current stimulation (tDCS), a putative treatment for depression, has been proposed to affect peripheral metabolism. Metabolic products from brain tissue may also cross the blood-brain barrier, reflecting the conditions in the brain. However, there are no previous data regarding the effect of tDCS on circulating metabolites.
Objective


To determine whether five daily sessions of tDCS modulate peripheral metabolites in healthy adult men.
Methods


This double-blind, randomized controlled trial involved 79 healthy males (aged 20-40 years) divided into two groups, one receiving tDCS (2 mA) and the other sham stimulated. The anode was placed over the left dorsolateral prefrontal cortex and the cathode over the corresponding contralateral area. Venous blood samples were obtained before and after the first stimulation session, and after the fifth stimulation session. Serum levels of 102 metabolites were determined by mass spectrometry. The results were analysed with generalised estimating equations corrected for the family-wise error rate. In addition, we performed power calculations estimating sample sizes necessary for future research.
Results


TDCS-related variation in serum metabolite levels was extremely small and statistically non-significant. Power calculations indicated that for the observed variation to be deemed significant, samples sizes of up to 11,000 subjects per group would be required, depending on the metabolite of interest.
Conclusion


Our study found that five sessions of tDCS induced no major effects on peripheral metabolites among healthy men. These observations support the view of tDCS as a safe treatment that does not induce significant changes in the measured peripheral metabolites in healthy male subjects.",2020,These observations support the view of tDCS as a safe treatment that does not induce significant changes in the measured peripheral metabolites in healthy male subjects.,"['healthy male subjects', 'healthy adult men', 'healthy men', '79 healthy males (aged 20-40 years']","['tDCS', 'Anodal tDCS', '\n\n\nTranscranial direct current stimulation (tDCS']","['serum metabolite levels', 'Venous blood samples', 'peripheral metabolites', 'Circulating Metabolites', 'Serum levels of 102 metabolites']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",79.0,0.0442171,These observations support the view of tDCS as a safe treatment that does not induce significant changes in the measured peripheral metabolites in healthy male subjects.,"[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Kortteenniemi', 'Affiliation': 'Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Ortega-Alonso', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Amir-Homayoun', 'Initials': 'AH', 'LastName': 'Javadi', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, United Kingdom.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Tolmunen', 'Affiliation': 'Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ali-Sisto', 'Affiliation': 'Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tuukka', 'Initials': 'T', 'LastName': 'Kotilainen', 'Affiliation': 'Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wikgren', 'Affiliation': 'Centre for Interdisciplinary Brain Research, Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karhunen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Velagapudi', 'Affiliation': 'Metabolomics Unit, Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Soili M', 'Initials': 'SM', 'LastName': 'Lehto', 'Affiliation': 'Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00403']
2250,32459005,Treatment with zoledronate subsequent to denosumab in osteoporosis: a randomized trial.,"Discontinuing denosumab is associated with bone loss and possibly increased fracture risk. We investigated if treatment with zoledronate could prevent bone loss and if the timing of the zoledronate infusion influenced the outcome. 2-year randomized, open label, interventional study including 61 patients with osteopenia, discontinuing denosumab after 4.6 ± 1.6 years. We administrated zoledronate six (6 M group, n = 20) or nine months (9 M group, n = 20) after the last denosumab injection or when bone turnover had increased (OBS group, n = 21). We monitored the patients with DXA and bone turnover markers. Our primary endpoints were change in lumbar spine BMD (LSBMD) six months after zoledronate and the proportion of patients who failed to maintain BMD. The study is ongoing (clinicaltrials.gov NCT03087851). We included 61 participants and 59 patients completed follow-up 12 months after zoledronate. Six months after zoledronate, LSBMD had decreased significantly by 2.1 ± 0.9% (mean ± SEM), 4.3 ± 1.1% and 3.0 ± 1.1% in the 6 M, 9 M and OBS groups, respectively and by 4.8 ± 0.7%, 4.1 ± 1.1%, and 4.7 ± 1.2% 12 months after zoledronate in the 6 M, 9 M and OBS groups, respectively (p < 0.02, no between group differences). BMD loss above the least significant change was seen in all groups; at the spine: 6 M: n = 6 (30%), 9 M: n = 9 (45%), OBS: n = 9 (47%); and at the total hip: 6 M: n = 1 (5%), 9 M: n = 5 (25%), OBS: n = 2 (11%). In the 6 M group p-cross-linked C-terminal telopeptide (p-CTX) decreased initially, but increased rapidly thereafter, and six months after ZOL, p-CTX was 0.60 ± 0.08 g/L. p-CTX increased rapidly in the 9 M and OBS groups, was suppressed by ZOL but increased again thereafter; p-CTX was 0.47 ± 0.05 μg/L and 0.47 ± 0.05 μg/L six months after zoledronate, respectively. Incident vertebral fractures were seen in two women in the 9 M group. Treatment with zoledronate irrespective of the timing did not fully prevent loss of BMD in patients discontinuing denosumab. This article is protected by copyright. All rights reserved.",2020,"Six months after zoledronate, LSBMD had decreased significantly by 2.1 ± 0.9% (mean ± SEM), 4.3 ± 1.1% and 3.0 ± 1.1% in the 6 M, 9 M and OBS groups, respectively and by 4.8 ± 0.7%, 4.1 ± 1.1%, and 4.7 ± 1.2% 12 months after zoledronate in the 6 M, 9 M and OBS groups, respectively (p < 0.02, no between group differences).","['61 participants and 59 patients completed follow-up 12\u2009months after zoledronate', 'patients with DXA and bone turnover markers', 'osteoporosis', '61 patients with osteopenia, discontinuing denosumab after 4.6\u2009±\u20091.6\u2009years']","['zoledronate', 'zoledronate subsequent to denosumab']","['BMD loss', 'LSBMD', 'lumbar spine BMD (LSBMD', 'bone loss', 'Incident vertebral fractures', 'loss of BMD', 'fracture risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",61.0,0.0298057,"Six months after zoledronate, LSBMD had decreased significantly by 2.1 ± 0.9% (mean ± SEM), 4.3 ± 1.1% and 3.0 ± 1.1% in the 6 M, 9 M and OBS groups, respectively and by 4.8 ± 0.7%, 4.1 ± 1.1%, and 4.7 ± 1.2% 12 months after zoledronate in the 6 M, 9 M and OBS groups, respectively (p < 0.02, no between group differences).","[{'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Sølling', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Harsløf', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4098']
2251,32459016,A randomized controlled study of 6% gabapentin topical formulation for chronic kidney disease-associated pruritus.,"BACKGROUND


Novel agents with good safety profiles are needed in the management of chronic kidney disease-associated pruritus (CKD-AP). This study aims to assess the efficacy and safety of topical gabapentin in the treatment of CKD-AP.
METHODS


The authors conducted a randomized, double-blind, vehicle-controlled study. The key inclusion criteria were: (i) patients on hemodialysis for at least 8 weeks, and (ii) a baseline visual analog scale (VAS) pruritus score ≥5. Patients were randomized into two groups. Topical 6% gabapentin was used in the experimental group while plain permeation cream was used for the control group. The primary endpoint was the mean change in pruritus scores using the VAS (MCPS-VAS) from baseline after 1 and 2 weeks of once daily application.
RESULTS


Thirty patients (15 per group) were included in the analysis. Treatment with 6% topical gabapentin resulted in significantly decreased mean pruritus scores at 1 week (mean score 2.7; range 0-5; P < 0.001) and 2 weeks (mean score 1.3, range 0-5; P < 0.001) from baseline (mean score 5.9; range 5-8). The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week. However, the MCPS-VAS of the experimental group (mean change -4.6; range 0-7) was significantly greater (P = 0.01) compared to control (mean change -2.6; range -1 to 5) after 2 weeks. There were no drug-related adverse events reported.
CONCLUSION


Our results suggest that short-term use of topical gabapentin may significantly decrease CKD-AP severity after 2 weeks with no reported acute adverse events.",2020,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"['chronic kidney disease-associated pruritus', 'Thirty patients (15 per group) were included in the analysis']","['gabapentin topical formulation', 'plain permeation cream', 'topical gabapentin', 'Topical 6% gabapentin']","['mean change in pruritus scores using the VAS (MCPS-VAS', 'CKD-AP severity', 'efficacy and safety', 'MCPS-VAS', 'baseline visual analog scale (VAS) pruritus score ≥5', 'mean pruritus scores']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.0514989,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"[{'ForeName': 'Terese Monette O', 'Initials': 'TMO', 'LastName': 'Aquino', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Karla Angela C', 'Initials': 'KAC', 'LastName': 'Luchangco', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Sanchez', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Vermen M', 'Initials': 'VM', 'LastName': 'Verallo-Rowell', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}]",International journal of dermatology,['10.1111/ijd.14953']
2252,32459035,"A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter Clinical Trial to Assess the Safety of 0.005% Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting.","LESSONS LEARNED


The levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone remained unchanged after a 12-week treatment with 0.005% estriol vaginal gel in postmenopausal women receiving nonsteroidal aromatase inhibitors for hormone receptor-positive early breast cancer. These results support the safety of 0.005% estriol vaginal gel for the treatment of bothering symptoms of vulvovaginal atrophy in breast cancer survivors. The results provide clinicians with confidence in the use of this product in women who do not experience symptom relief with nonhormonal remedies.
BACKGROUND


Symptoms of vulvovaginal atrophy associated with treatment with nonsteroidal aromatase inhibitors (NSAIs) negatively impact patients' quality of life and may affect adherence to NSAIs. Vaginal estrogens effectively improve these symptoms, although their safe use in breast cancer survivors remains unclear.
METHODS


Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness were randomized to 0.005% estriol vaginal gel or placebo for 12 weeks. Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH), were analyzed at baseline and at weeks 1, 3, 8, and 12. The primary safety outcome was the variation in serum FSH from baseline to week 12.
RESULTS


Sixty-one women (mean age, 59 years) enrolled in the study. Small oscillations were observed in FSH and LH, although they were always maintained within the postmenopausal range. No significant differences were found in the variation of FSH and LH between baseline and week 12 from the physiological variation observed before treatment. Women receiving 0.005% estriol vaginal gel had slightly increased estriol levels at weeks 1 and 3, with a subsequent reduction until normalizing at week 12; estradiol and estrone remained the below limit-of-quantitation in almost all samples.
CONCLUSION


Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI. A transient negligible absorption of estriol and a nonsignificant variation of FSH after 12 weeks were observed. These findings provide confidence for the safe use of 0.005% estriol vaginal gel in women with breast cancer with an indication for treatment with vaginal estrogens.",2020,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","['women with breast cancer with an indication for treatment with vaginal estrogens', 'Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness', 'postmenopausal women receiving', 'women with breast cancer receiving NSAI', 'breast cancer survivors', 'Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting', 'women who do not experience symptom relief with nonhormonal remedies', 'Sixty-one women (mean age, 59\u2009years) enrolled in the study']","['estriol vaginal gel', 'nonsteroidal aromatase inhibitors (NSAIs', 'Placebo', 'Estriol Vaginal Gel', 'Ultralow-dose 0.005% estriol vaginal gel', 'estriol vaginal gel or placebo', 'nonsteroidal aromatase inhibitors']","['Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'variation of FSH and LH', 'variation in serum FSH', 'estrogens, FSH, and LH levels', 'estriol levels', 'levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517389', 'cui_str': '0.005'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0337435', 'cui_str': 'Estriol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",61.0,0.0682912,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Rovira', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Jaén, Jaén, Spain.'}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institute and Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo-De Las Heras', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'Medical Department, Italfarmaco, SA, Milan, Italy.'}]",The oncologist,['10.1634/theoncologist.2020-0417']
2253,32459377,Validation of the 7-item Functional Assessment of Cancer Therapy-General (FACT-G7) as a short measure of quality of life in patients with advanced cancer.,"BACKGROUND


Assessing quality of life is essential for individuals with advanced cancer, but lengthy assessments can be burdensome. The authors investigated the psychometric characteristics of the FACT-G7, a 7-item quality-of-life measure derived from the Functional Assessment of Cancer Therapy-General (FACT-G) scale, in advanced cancer.
METHODS


Data were obtained from outpatients with advanced cancer who were enrolled in a randomized controlled trial of early palliative care. At baseline, 228 intervention participants and 233 control participants (N = 461) completed the FACT-G and measures of symptom severity, quality of life near the end of life, problematic medical communication, and satisfaction with care. Follow-up measures were administered monthly for 4 months.
RESULTS


The FACT-G7 showed good internal consistency (Cronbach α = .72-.80), and its single-factor structure was supported. It correlated strongly with the FACT-G total, physical, and functional indices and with symptom severity (absolute r = 0.73-0.92); more moderately with the FACT-G emotional index and with symptom impact and preparation for the end of life (r = .40-.71); and least with the FACT-G social/family index and with relationship with health care provider, life completion, problematic medical communication, and care satisfaction measures (absolute r = .26-.44). Eastern Cooperative Oncology Group performance status groups differed on FACT-G7 scores, as expected (all P < .001). Improvements in FACT-G7 scores in the intervention group compared with the control group at 3-month (P = .049) and 4-month (P = .034) follow-up supported responsiveness to change and somewhat greater sensitivity than the FACT-G scores.
CONCLUSIONS


The FACT-G7 is a valid, brief measure particularly of the physical and functional facets of quality of life. It may enable rapid quality-of-life assessments in patients with advanced cancer.",2020,"(P = .034) follow-up supported responsiveness to change and somewhat greater sensitivity than the FACT-G scores.
","['individuals with advanced cancer', '228 intervention participants and 233 control participants (N\xa0=\xa0461', 'Data were obtained from outpatients with advanced cancer who were enrolled in a randomized controlled trial of early palliative care', 'patients with advanced cancer']",['Cancer Therapy-General'],"['quality of life', 'Functional Assessment of Cancer Therapy-General (FACT-G) scale', 'FACT-G total, physical, and functional indices and with symptom severity', 'FACT-G and measures of symptom severity, quality of life near the end of life, problematic medical communication, and satisfaction with care', 'FACT-G7 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",461.0,0.0598682,"(P = .034) follow-up supported responsiveness to change and somewhat greater sensitivity than the FACT-G scores.
","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mah', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Swami', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Lisa W', 'Initials': 'LW', 'LastName': 'Le', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Chow', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Breffni L', 'Initials': 'BL', 'LastName': 'Hannon', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rodin', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}]",Cancer,['10.1002/cncr.32981']
2254,32459394,Parent reports of sun safety communication and behaviour for students in a randomised trial on a school policy implementation intervention.,"OBJECTIVE


Schools are an important setting for skin cancer prevention. An intervention for implementation of school sun safety policy, Sun Safety Schools (SSS), was evaluated.
METHODS


Primary schools (n=118) in California school districts that had already adopted a sun safety policy were enrolled in a study with a randomised controlled design. Half of the schools were randomised to SSS intervention (N=58). Parents completed an online post-test.
RESULTS


More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively). In schools where principals reported implementing sun safety practices, parents reported that children spent less time outdoors at midday (mean=14.78 hours, sd=0.25, p=0.033) and fewer were sunburned (mean=12.7%, sd=1.1%, p=0.009) than in non-implementing schools (M=16.3 hours, sd=0.67; mean=21.2%, sd=3.8%, respectively). Parents who received sun safety information (mean=3.08, sd=0.04, p=0.008) reported more child sun protection than parents not receiving information (mean=2.96, sd=0.02).
CONCLUSIONS


A school district sun protection policy and support for implementation increased dissemination of sun safety information to parents and student sun safety. Implications for public health: Technical assistance for sun safety policies may increase sun protection of children.",2020,"More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively).","['Primary schools (n=118) in California school districts that had already adopted a sun safety policy', 'public health', 'children']","['SSS intervention', 'sun safety information']","['children spent less time outdoors at midday', 'information about sun safety', 'child sun protection']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0585020', 'cui_str': 'Noon'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.152215,"More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, California, US.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, California, US.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, California, US.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, Oregon, US.'}]",Australian and New Zealand journal of public health,['10.1111/1753-6405.12987']
2255,32459420,Cannabinoids for Pain Control During Medical Abortion: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether prophylactic dronabinol, a synthetic tetrahydrocannabinol, reduces pain during medical abortion.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial of women undergoing medical abortion with mifepristone and misoprostol up through 70 days of gestation. All participants received 800 mg of ibuprofen and were randomized to either 5 mg of oral dronabinol or a placebo 30 minutes before misoprostol administration. Participants used a text messaging service to report pain on a numeric rating scale from 0 to 10 (0=no pain, 10=worst pain). The primary outcome was maximum pain experienced during the 24 hours after misoprostol administration. Secondary outcomes were pain scores at 0, 6, and 24 hours after misoprostol administration; maximum anxiety and nausea scores; use of additional pain medication; reported side effects; and satisfaction (yes or no). We needed 68 participants (34 per group) to have 80% power to detect a 2-point difference in maximum pain on a numeric rating scale.
RESULTS


From November 2018 to May 2019, we randomized 70 women (dronabinol=35, placebo=35). Participants in the study arms had comparable baseline characteristics. We found no difference between groups in the median maximum pain score reported (dronabinol 7 [interquartile range 6-8], placebo 7 [interquartile range 5-8], P=.82) or median pain scores at any timepoint. Groups were also no different in mean maximum anxiety (dronabinol 3.33 [SD 3.06], placebo 3.23 [SD 2.53], P=.88) or nausea scores (dronabinol 2.21 [SD 2.32], placebo 2.72 [SD 2.64], P=.41). Most women were satisfied with their pain management (76% dronabinol, 82% placebo, P=.51).
CONCLUSION


Dronabinol does not reduce the maximum level of pain experienced by women undergoing medical abortion.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03604341.",2020,"Most women were satisfied with their pain management (76% dronabinol, 82% placebo, P=.51).
","['women undergoing medical abortion with', 'up through 70 days of gestation']","['mifepristone and misoprostol', 'prophylactic dronabinol', 'oral dronabinol', 'Dronabinol', 'ibuprofen', 'placebo']","['Pain Control', 'pain scores', 'maximum pain on a numeric rating scale', 'median pain scores', 'maximum level of pain', 'nausea scores', 'maximum anxiety and nausea scores; use of additional pain medication; reported side effects; and satisfaction (yes or no', 'median maximum pain score', 'mean maximum anxiety', 'maximum pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",70.0,0.834731,"Most women were satisfied with their pain management (76% dronabinol, 82% placebo, P=.51).
","[{'ForeName': 'Alyssa Covelli', 'Initials': 'AC', 'LastName': 'Colwill', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Alton', 'Affiliation': ''}, {'ForeName': 'Paula H', 'Initials': 'PH', 'LastName': 'Bednarek', 'Affiliation': ''}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Bayer', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Beardsworth', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edelman', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003850']
2256,32459423,Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.,"OBJECTIVE


To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.
METHODS


Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies.
RESULTS


From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}.
CONCLUSION


Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02925494.
FUNDING SOURCE


AbbVie Inc funded this study.",2020,Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3,"['Women With Heavy Menstrual Bleeding and Uterine Leiomyomas', 'From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND', 'women with heavy menstrual bleeding associated with uterine leiomyomas', 'women with uterine leiomyomas']","['elagolix with add-back therapy', 'elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate', 'oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy', 'elagolix', 'Elagolix']","['headache', 'bone mineral density', 'adverse events and bone mineral density changes', 'menstrual blood loss', 'percentage of women with both less than 80 mL menstrual blood loss', 'adverse events', 'night sweats', 'nausea']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0985841', 'cui_str': 'Estradiol 1 MG'}, {'cui': 'C0068980', 'cui_str': 'Norethindrone acetate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",433.0,0.171702,Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, IntimMedicine Specialists, Washington, DC; University of Illinois at Chicago, Chicago, Illinois; Eastern Virginia Medical School, Norfolk, Virginia; Perleman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Cleveland Clinic, Cleveland, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; Attia Medical, San Diego, California; Northwestern University, Chicago, Illinois; Ochsner Health System, New Orleans, Louisiana; University of Texas Health Science Center at Houston, Houston, Texas; Columbia University, New York, New York; AbbVie Inc, North Chicago, Illinois; SUNY Downstate Health Science University, Brooklyn, New York; Mercy Health, Cincinnati, Ohio; and Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Hendy', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': ''}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': ''}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dayspring', 'Affiliation': ''}, {'ForeName': 'Eve C', 'Initials': 'EC', 'LastName': 'Feinberg', 'Affiliation': ''}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Gillispie', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hurtado', 'Affiliation': ''}, {'ForeName': 'JinHee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Charlotte D', 'Initials': 'CD', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Muneyyirci-Delale', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003869']
2257,32459426,Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effect of a personalized repeated feedback approach using digital step counters (pedometers) on mobility after cesarean delivery in high-risk patients.
METHODS


This was a randomized controlled trial at a tertiary university hospital. Patients who underwent cesarean delivery and were defined as high risk for thromboembolic events were asked to wear a pedometer around their wrists postpartum for 48 hours. Patients were randomized to the feedback group, which received personalized feedback by the research staff regarding their mobility at three set timepoints, or the control group, which received standard care. The number of steps taken by patients was compared between the groups and served as the primary outcome. Secondary outcomes included patient reported pain, physical and mental recovery, and overall satisfaction. Sample size was predetermined to detect a 25% between-group difference in the primary outcome.
RESULTS


From December 2018 to July 2019, 215 patients were recruited, randomized and completed follow-up-108 in the feedback group and 107 in the control group. Patients' demographics and intrapartum course were similar between the groups. The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918±3,116 vs 4,161±2,532 steps, P<.001. Pain scores were similar between the groups, as was analgesic consumption. Patients in the feedback group reported a significantly easier physical and mental postpartum recovery and were significantly more satisfied with their delivery experience. Postpartum complications did not differ between the groups.
CONCLUSION


In high-risk patients after cesarean delivery, mobility was improved by using a personalized feedback approach. Enhanced mobility was not associated with a higher rate of complications or pain and was positively associated with patient satisfaction.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03724760.",2020,"The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918±3,116 vs 4,161±2,532 steps, P<.001.","['From December 2018 to July 2019, 215 patients were recruited, randomized and completed follow-up-108 in the feedback group and 107 in the control group', 'high-risk patients', 'tertiary university hospital']","['personalized repeated feedback approach using digital step counters (pedometers', 'Digital Step Counter Feedback', 'personalized feedback']","['Enhanced mobility', 'rate of complications or pain', 'easier physical and mental postpartum recovery', 'number of steps taken', 'Mobility', 'Postpartum complications', 'patient reported pain, physical and mental recovery, and overall satisfaction', 'high risk for thromboembolic events', 'Pain scores']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0677601', 'cui_str': 'Counter'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",215.0,0.204489,"The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918±3,116 vs 4,161±2,532 steps, P<.001.","[{'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Ganer Herman', 'Affiliation': 'Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Kleiner', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tairy', 'Affiliation': ''}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Gonen', 'Affiliation': ''}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Ben Zvi', 'Affiliation': ''}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kovo', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bar', 'Affiliation': ''}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003879']
2258,32453692,"Is thromboprophylaxis with high-dose enoxaparin really necessary for COVID-19 patients? A new ""prudent"" randomised clinical trial.",,2020,,[],['enoxaparin'],[],[],"[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]",[],,0.0745384,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'Intensive Cardiac Care Unit and ""De Gasperis"" Cardio Center, ""ASST Grande Ospedale Metropolitano Niguarda"", Milan, Italy.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0109-20']
2259,32453693,"Rebuttal to letter ""Is thromboprophylaxis with high-dose enoxaparin really necessary for COVID-19 patients? A new ""prudent"" randomised clinical trial"".",,2020,,[],['enoxaparin'],[],[],"[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]",[],,0.0575995,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Department of Oncology and Haematology, University Hospital, Modena, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Tripodi', 'Affiliation': '""IRCCS Ca\' Granda Maggiore"" Hospital Foundation, ""Angelo Bianchi Bonomi"" Haemophilia and Thrombosis Center and ""Fondazione Luigi Villa"", Milan, Italy.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0116-20']
2260,32453759,"Postoperative analgesia using dezocine alleviates depressive symptoms after colorectal cancer surgery: A randomized, controlled, double-blind trial.","BACKGROUND


Postoperative depression is one of the most common mental disorders in patients undergoing cancer surgery and it often delays postoperative recovery. We investigated whether dezocine, an analgesic with inhibitory effect on the serotonin and norepinephrine reuptake, could relieve postoperative depressive symptoms in patients undergoing colorectal cancer surgery.
METHODS


This randomized, controlled, single-center, double-blind trial was performed in the Second Affiliated Hospital of the Army Medical University. A total of 120 patients were randomly assigned to receive either sufentanil (1.3 μg/kg) with dezocine (1 mg/kg) (dezocine group; n = 60) or only sufentanil (2.3 μg/kg) (control group; n = 60) for patient-controlled intravenous analgesia after colorectal cancer surgery. The primary outcome was the Beck Depression Inventory score at 2 days after surgery. The secondary outcomes included the Beck Anxiety Inventory, sleep quality, and quality of recovery scores.
RESULTS


Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001). No significant difference was found in other outcomes between the two groups.
CONCLUSIONS


Intravenous analgesia using dezocine can relieve postoperative depression symptoms and improve sleep quality in patients undergoing colorectal cancer surgery.",2020,"Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001).","['patients undergoing colorectal cancer surgery', 'A total of 120 patients', 'patients undergoing cancer surgery', 'alleviates depressive symptoms after colorectal cancer surgery', 'Second Affiliated Hospital of the Army Medical University']","['dezocine (1 mg/kg) (dezocine group; n = 60) or only sufentanil (2.3 μg/kg) (control group; n = 60) for patient-controlled intravenous analgesia after colorectal cancer surgery', 'sufentanil', 'dezocine', 'serotonin and norepinephrine reuptake']","['night sleep quality', 'lower depression scores', 'postoperative depressive symptoms', 'Beck Anxiety Inventory, sleep quality, and quality of recovery scores', 'postoperative depression symptoms', 'sleep quality', 'Beck Depression Inventory score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0362037', 'cui_str': 'Postoperative depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}]",120.0,0.70306,"Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001).","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Zhuoxi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Chunrui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guiying', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}]",PloS one,['10.1371/journal.pone.0233412']
2261,32453774,"Effect of guided counseling on dietary practices of pregnant women in West Gojjam Zone, Ethiopia.","BACKGROUND


In Ethiopia, although nutrition education has been given during pregnancy, most women have inadequate nutrient intakes. As a result, the prevalence of malnutrition is high during pregnancy. In this study, we set out to evaluate the effect of guided counseling based on the health belief model and the theory of planned behavior on the dietary practices of pregnant women.
METHODS


A two-arm parallel cluster randomized controlled community trial was carried out among pregnant women in West, Gojjam Zone, Ethiopia from May 1, 2018, to April 30, 2019. A total of 346 and 348 pregnant women were recruited from the intervention and control clusters, respectively. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control groups, respectively. Each woman in the intervention group attended four counseling sessions. Women in the control group attended the routine nutrition education given by the health care system. Data were collected using a structured questionnaire. McNemar test and Generalized Estimating Equations were used to evaluate the intervention effect.
RESULTS


The average difference of appropriate dietary practice between the two groups was 30.7%. After controlling for the possible confounders, women in the intervention group had 7.2 times [AOR = 7.187, 95% CI: (4.49, 11.49)] higher odds of having appropriate dietary practices compared with the control group. Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively.
CONCLUSION


Counseling based on the health belief model and the theory of planned behavior is an effective approach in increasing the proportion of women who had appropriate dietary practices. Thus, these findings suggest the need for employing trimester based counseling using the HBM and the TPB to improve the dietary practices of pregnant women.
TRIAL REGISTRATION


The trial was registered in Clinical Trials.gov (NCT03627156).",2020,"Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively.
","['A total of 346 and 348 pregnant women', '313 and 332 pregnant women in the intervention and control groups, respectively', 'pregnant women in West, Gojjam Zone, Ethiopia from May 1, 2018, to April 30, 2019', 'pregnant women in West Gojjam Zone, Ethiopia', 'women who had appropriate dietary practices', 'pregnant women']","['routine nutrition education', 'guided counseling']",['Dietary diversity and meal frequency'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0585045,"Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively.
","[{'ForeName': 'Yeshalem Mulugeta', 'Initials': 'YM', 'LastName': 'Demilew', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.'}, {'ForeName': 'Getu Degu', 'Initials': 'GD', 'LastName': 'Alene', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Public Health, Jimma University, Jimma, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0233429']
2262,32453835,A brief sleep focused psychoeducation program for sleep-related outcomes in new mothers: A randomised controlled trial.,"STUDY OBJECTIVES


Poor sleep is commonly problematic during pregnancy and postpartum and is associated with depression. This trial investigated the efficacy of prenatal brief, group sleep psychoeducation in improving postpartum maternal sleep and depression.
METHODS


215 healthy expectant first-time mothers were cluster randomised (1:1) to receive either a 2 x 1.5hr psychoeducation intervention and a set of booklets, or a set of booklets only. Participants completed questionnaires during pregnancy (pre-intervention), and 6 weeks and 4 months postpartum. A post-hoc subset of questionnaires was collected at 10 months postpartum. The primary hypothesis was the intervention group would have improved postpartum sleep quality, and reduced levels of insomnia symptoms, fatigue and daytime sleepiness compared to the control group. Secondary outcomes included depression, anxiety and stress.
RESULTS


Linear mixed model analyses failed to confirm a group by time interaction on primary or secondary outcomes across all time points. There was no effect of the intervention on outcomes at six weeks, or ten months postpartum. A significant time by group interaction was found at four months, favouring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness.
CONCLUSIONS


Prenatal sleep psychoeducation did not produce a sustained effect on maternal sleep throughout the postpartum period. There was little evidence of benefits on depressive symptoms.",2020,"A significant time by group interaction was found at four months, favouring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness.
","['new mothers', '215 healthy expectant first-time mothers']","['prenatal brief, group sleep psychoeducation', 'Prenatal sleep psychoeducation', '2 x 1.5hr psychoeducation intervention', 'psychoeducation program']","['postpartum maternal sleep and depression', 'fatigue or daytime sleepiness', 'maternal sleep', 'depression, anxiety and stress', 'insomnia symptoms', 'postpartum sleep quality', 'sleep quality', 'depressive symptoms', 'levels of insomnia symptoms, fatigue and daytime sleepiness']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",215.0,0.0839392,"A significant time by group interaction was found at four months, favouring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness.
","[{'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Kempler', 'Affiliation': 'School of Psychology, University of Sydney, Sydney.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Sydney.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Sleep and Circadian Research Group (CIRUS) and NeuroSleep Centre of Research Excellence, Woolcock Institute of Medical Research, University of Sydney.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Sleep and Circadian Research Group (CIRUS) and NeuroSleep Centre of Research Excellence, Woolcock Institute of Medical Research, University of Sydney.'}]",Sleep,['10.1093/sleep/zsaa101']
2263,32453997,"Does a single bout of exercise impacts BDNF, oxidative stress and epigenetic markers in spinal cord injury patients?","Our aim was to evaluate the impact of a single bout of exercise, consisting of a gait training session with body weight support (BWS), on histone acetylation status (global histone H4 and H3 acetylation levels), brain-derived neurotrophic factor (BDNF) levels, and oxidative stress markers in peripheral blood of individuals with chronic spinal cord injury (SCI). We also set out to compare these responses with those recorded after gait training performed using a walker and with no BWS. The subjects (nearly all with an incomplete spinal cord lesion) were each submitted to two 60-minute experimental sessions on separate days with a 1- week wash-out period between the interventions. The order of the sessions was randomized. Blood samples were collected before and after each experimental trial for measurement of biomarkers. The histone acetylation status and BDNF levels remained unchanged after both interventions. After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators. Instead, elevations in AOPP and nitrite concentrations, in addition to increased levels of glutathione and catalase activity, were found after the walker training. A single bout of gait training, be it conducted on a treadmill with BWS or using a walker without BWS, is not able to alter BDNF levels and histone acetylation status in SCI patients. However, these trials can modulate oxidative stress parameters, seemingly in a protocol-dependent manner.",2019,"After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators.","['subjects (nearly all with an incomplete spinal cord lesion', 'SCI patients', 'peripheral blood of individuals with chronic spinal cord injury (SCI', 'spinal cord injury patients']","['gait training', 'gait training session with body weight support (BWS']","['histone acetylation status (global histone H4 and H3 acetylation levels), brain-derived neurotrophic factor (BDNF) levels, and oxidative stress markers', 'histone acetylation status and BDNF levels', 'levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances', 'levels of glutathione and catalase activity', 'BDNF levels and histone acetylation status', 'AOPP and nitrite concentrations']","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0019652', 'cui_str': 'Histone'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}]",,0.0555968,"After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators.","[{'ForeName': 'Melissa Grigol', 'Initials': 'MG', 'LastName': 'Goldhardt', 'Affiliation': ''}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Andreia', 'Affiliation': ''}, {'ForeName': 'Gilson P', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': ''}, {'ForeName': 'Ivy Reichert', 'Initials': 'IR', 'LastName': 'da Silva', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': ''}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Rostirola Elsner', 'Affiliation': ''}]",Functional neurology,[]
2264,32454078,Situated food safety behavior.,"Previous studies indicate that many consumers eat rare hamburgers and that information about microbiological hazards related to undercooked meat does not necessarily lead to changed behavior. With this study we aim to investigate whether consumers' willingness to eat hamburgers, both risky and safe, depends on the situation where they are confronted with the food. A representative sample of 1046 Norwegian consumers participated in a web experiment. Participants were randomly divided into four groups. Each group was told to imagine a specific eating situation (at their friend's place, at home, at a restaurant abroad, at a domestic restaurant). Four pictures of hamburgers (rare, medium rare, medium, well-done) were presented in randomized order, and participants rated their intentions to eat each hamburger. Situated risk perception was measured as the stated likelihood of food poisoning from consuming hamburgers in eight different situations. The results show that both risk perception and risk taking vary depending on the situation. In general, participants perceive their own home to be the safest place to consume a hamburger, but they are significantly more likely to consume an undercooked hamburger when at a friend's place. These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception. That risk taking is elevated in situations that may have social consequences should be taken into consideration when developing food safety strategies.",2020,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.",['1046 Norwegian consumers participated in a web experiment'],[],['Situated risk perception'],"[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",1046.0,0.0220725,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.","[{'ForeName': 'Nina Veflen', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'BI Norwegian Business School, Norway; Nofima, Norway. Electronic address: nina.veflen@bi.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Røssvoll', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Langsrud', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Scholderer', 'Affiliation': 'NMBU, Norwegian University of Life Sciences, Norway; University of Zürich, Switzerland.'}]",Appetite,['10.1016/j.appet.2020.104751']
2265,32454087,Conventional versus daylight photodynamic therapy for acne vulgaris: A randomized and prospective clinical study in China.,"BACKGROUND


Photodynamic therapy (PDT) is an effective and safe treatment modality for acne vulgaris, and a variety of light sources have been investigated. Sunlight has been used as a PDT light source in limited acne studies over the past years. However, to date, a comparative study of conventional PDT (C-PDT) and daylight PDT (DL-PDT) on acne is still lacking.
OBJECTIVES


This study aims to assess the efficacy and safety of DL-PDT vs. C-PDT in the treatment of acne vulgaris.
METHODS


Eighty patients with facial moderate-to-severe acne vulgaris were randomly assigned to either DL-PDT group or C-PDT group. All patients got two to three treatment sessions at two-week intervals. The lesions were photographed with VISIA digital imaging system at baseline and weeks 2, 4, and 6. Follow-up monthly for 3 months. The endpoints include efficacy (lesion response), safety (VAS pain score) and patient satisfaction.
RESULTS


A total of 77 patients completed the study. There was no statistics difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0%, 90.0%, and 94.7% vs. 45.0%, 85.0%, and 92.3%, p > 0.05). The IGA score of DL-PDT group has no difference from C-PDT at baseline and at weeks 6, respectively (3.3 ± 0.4, 1.5 ± 0.7 vs. 3.4 ± 0.5, 1.6 ± 0.7, p > 0.05). The VAS pain score of DL-PDT group was lower than that of C-PDT group (1.8 ± 0.2, vs. 5.8 ± 0.3, p < 0.05). Adverse reactions such as mild burning sensation, erythema, dryness, crusting, scales and hyperpigmentation were all tolerated. Patient satisfaction was similar between the two groups (p > 0.05).
CONCLUSIONS


DL-PDT is an effective and well-tolerated alternative regimen for moderate-to-severe acne vulgaris compared with C-PDT.",2020,"There was no statistics difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0%, 90.0%, and 94.7% vs. 45.0%, 85.0%, and 92.3%, p > 0.05).","['Eighty patients with facial moderate-to-severe acne vulgaris', '77 patients completed the study', 'acne vulgaris']","['DL-PDT vs. C-PDT', 'Photodynamic therapy (PDT', 'Conventional versus daylight photodynamic therapy', 'DL-PDT group or C-PDT group', 'conventional PDT (C-PDT) and daylight PDT (DL-PDT']","['Patient satisfaction', 'VAS pain score', 'mild burning sensation, erythema, dryness, crusting, scales and hyperpigmentation were all tolerated', 'efficacy (lesion response), safety (VAS pain score) and patient satisfaction', 'efficacy and safety', 'objective response rate']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",80.0,0.0492389,"There was no statistics difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0%, 90.0%, and 94.7% vs. 45.0%, 85.0%, and 92.3%, p > 0.05).","[{'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: zglamu@163.com.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: wangxiuli20150315@163.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101796']
2266,32454161,Acute methylphenidate administration reduces cocaine-cue attentional bias.,"Mechanistic research on behavioral processes underlying substance use disorder might help identify novel targets for interventions development. Drug-related attentional bias and response inhibition deficits have received a great deal of consideration in substance use research, broadly, and cocaine use research, specifically. Studies investigating pharmacological mechanisms that may ameliorate, or further impair, these behaviors relevant to cocaine use are relatively lacking. This study evaluated the impact of acute administration of methylphenidate, a dopamine favoring reuptake inhibitor, on both gaze-related cocaine cue attentional bias and cocaine-cue related disruptions in response inhibition among individuals with cocaine use disorder. Participants (N = 12; 33% female) completed a within-subject, outpatient, acute dosing study. Two sessions were completed in which methylphenidate (60 mg) or placebo were administered followed by completion of an attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks. Subjective and physiological effects were also recorded. Significant cocaine cue attentional bias and response inhibition failures were observed during placebo administration. Acute methylphenidate administration reduced cocaine-cue attentional bias as measured by cocaine-cue gaze fixations (d z  = 1.04; Bayes Factor = 12.37). No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04). Methylphenidate produced prototypical subjective and physiological effects. Although the small sample should be considered, these findings indicate acute manipulation of dopaminergic activity reduced cue-related attentional allocation related to cocaine use disorder. Future research evaluating alternative dopaminergic agents and applications within a clinical setting are needed to determine the clinical significance of targeting this neurobehavioral mechanism.",2020,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"['individuals with cocaine use disorder', 'Participants (N\u202f=\u202f12; 33% female) completed a within-subject, outpatient, acute dosing study']","['cocaine-cue gaze fixations ', 'attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks', 'methylphenidate', 'Methylphenidate', 'Acute methylphenidate', 'placebo']","['prototypical subjective and physiological effects', 'response inhibition', 'cocaine-cue attentional bias', 'Subjective and physiological effects', 'Significant cocaine cue attentional bias and response inhibition failures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",2.0,0.0536529,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Alcorn', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA. Electronic address: Craig.Rush@uky.edu.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109974']
2267,32454191,Patient Perceptions on a Non-Blinded Randomized Trial of Radiotherapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.,"PURPOSE


Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiotherapy technology.
METHODS


Patients with breast cancer enrolled on a randomized clinical trial evaluating intensity modulated radiotherapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiotherapy (3DCRT) completed surveys at baseline, after randomization, and upon completion of radiotherapy to evaluate expectations, satisfaction, and experiences.
RESULTS


Among 35 women surveyed, most endorsed the perception that participation on the trial might result in better treatment than the current standard treatment (77%) and more medical attention than off trial (54%). At baseline, most (74%) believed that a new treatment technology is superior than an established one. Prior to randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none felt that 3DCRT would be more effective, 23% felt that they would be the same, and 34% didn't know. None felt that IMRT-DIBH would cause worse long-term side effects, whereas 37% felt that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
CONCLUSIONS


Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.",2020,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
","['35 women surveyed', 'Patients with breast cancer enrolled']","['3DCRT', 'Radiotherapy Technologies', 'intensity modulated radiotherapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiotherapy (3DCRT']",['medical attention'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",35.0,0.156869,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
","[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Shumway', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Motomura', 'Affiliation': 'Center for Law & the Biosciences and Stanford Program in Neuroscience & Society, Stanford Law School.'}, {'ForeName': 'Kent A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'Department of Radiation Oncology, University of Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hayman', 'Affiliation': 'Department of Radiation Oncology, University of Michigan.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Department of Radiation Oncology, University of Michigan.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Jagsi', 'Affiliation': 'Department of Radiation Oncology, University of Michigan. Electronic address: rjagsi@med.umich.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.021']
2268,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A  receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 min after blinded oral administration of placebo and 10 mg/70 kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study uses a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A  receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980']
2269,32454239,Randomized Clinical Trial of Radiofrequency Induced Thermotherapy Combined with Transilluminated Powered Phlebectomy versus High Ligation and Stripping for the Treatment of Lower Limb Varicose Veins.,"PURPOSE


To evaluate the efficacy and safety of radiofrequency induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP.
METHODS


The patients with lower limb VVs were randomly divided into RFiTT combined with TIPP group or HLS combined with TIPP group. The primary endpoint was the total closure rate of great saphenous vein (GSV) at 12 months. Secondary endpoints included Venous Clinical Severity Score (VCSS), Chronic Venous Insufficiency Questionnaire (CIVIQ-14) scores changes at 12 months and perioperative complications.
RESULTS


The total closure rate of GSV at 12 months was slightly lower with RFiTT Group (90.9%, 90/99) than that with HLS Group (97.0%, 98/101), but not statistically significantly (χ 2 =0.068, P=0.08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, resumption of activities was statistically significantly better with RFiTT than with HLS. There were no significantly differences between the two groups in DVT, phlebitis, haematomas, pain and infection. But skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in VCSS scores (1.28±0.57 in RFiTT group vs. 1.33±0.61 in HLS group) and CIVIQ-14 scores (67.32±1.29 in RFiTT group vs. 67.45±1.32 in HLS group), however, neither group was superior to the other.
CONCLUSION


RFiTT combined with TIPP is an effective treatment method for lower limb VVs, and had a more satisfactory clinical outcome in surgical data, skin pigmentation and paresthesia than HLS at the 12 months follow up.",2020,"There were no significantly differences between the two groups in DVT, phlebitis, haematomas, pain and infection.","['Lower Limb Varicose Veins', 'patients with lower limb VVs']","['Radiofrequency Induced Thermotherapy', 'RFiTT', 'Transilluminated Powered Phlebectomy versus High Ligation and Stripping', 'RFiTT combined with TIPP', 'HLS', 'high ligation and stripping (HLS) combined with TIPP', 'RFiTT combined with TIPP group or HLS combined with TIPP', 'radiofrequency induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP']","['VCSS scores', 'DVT, phlebitis, haematomas, pain and infection', 'CIVIQ-14 scores', 'efficacy and safety', 'Operation time, intraoperative blood loss, duration in hospital, duration in bed, resumption of activities', 'Venous Clinical Severity Score (VCSS), Chronic Venous Insufficiency Questionnaire (CIVIQ-14) scores changes at 12 months and perioperative complications', 'total closure rate of GSV', 'But skin pigmentation and paresthesia', 'total closure rate of great saphenous vein (GSV']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0191017', 'cui_str': 'Excision of vein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",,0.051101,"There were no significantly differences between the two groups in DVT, phlebitis, haematomas, pain and infection.","[{'ForeName': 'Chuan-Jun', 'Initials': 'CJ', 'LastName': 'Liao', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Wang-de', 'Initials': 'WD', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China. Electronic address: zhangwang_de@163.com.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.04.028']
2270,32454259,An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.,,2020,,['Suspected Malignant Hilar Obstruction'],['Percutaneous vs Endoscopic Drainage'],[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],,0.0860146,,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC. Electronic address: elmunzer@musc.edu.'}, {'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Smith', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tarnasky', 'Affiliation': 'Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, TX.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yachimski', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Banovac', 'Affiliation': 'Division of Interventional Radiology, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Buscaglia', 'Affiliation': 'Division of Gastroenterology, Stony Brook University, Stony Brook, NY.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Buxbaum', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Draganov', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL.'}, {'ForeName': 'Kulwinder', 'Initials': 'K', 'LastName': 'Dua', 'Affiliation': 'Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Geller', 'Affiliation': 'Division of Interventional Radiology, University of Florida, Gainesville, FL.'}, {'ForeName': 'Laith H', 'Initials': 'LH', 'LastName': 'Jamil', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Rajesh N', 'Initials': 'RN', 'LastName': 'Keswani', 'Affiliation': 'Division of Gastroenterology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Lo', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Division of Gastroenterology, Ohio State University, Columbus, OH.'}, {'ForeName': 'J Bayne', 'Initials': 'JB', 'LastName': 'Selby', 'Affiliation': 'Division of Interventional Radiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Division of Gastroenterology, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University, Atlanta, GA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.035']
2271,32454317,Web-based experiential learning strategies to enhance the evidence-based-practice competence of undergraduate nursing students.,"BACKGROUND


Evidence-based practice (EBP) is considered a key competence for practicing high-quality and safe nursing. However, undergraduate nursing programs continue to provide traditional classroom teaching strategies that have limitations in facilitating the development of critical competences for engaging in EBP in real clinical contexts.
OBJECTIVE AND DESIGN


The purpose of this study was to develop a web-based experiential learning program aimed at improving the engagement and experience of nursing students in EBP. A quasi-experimental research with non-equivalent control-group with non-synchronized design was used to describe the process of program development and the innovative learning method, and discuss the outcomes of the program.
METHODS


The experimental group was exposed to a web-based experiential learning program, while the control group received traditional learning with written material. Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence were evaluated to assess the effects of the program.
RESULTS


The result showed that web-based experiential learning strategies were effective in significantly improving the EBP knowledge and skills score (F = 12.29, p = .001) and the score for confidence in asking clinical questions (F = 12.14, p = .001). The attitudes toward EBP (F = 0.75, p = .389) and practice score (F = 3.22, p = .076) did not show a significant difference between the experimental group and the control group.
CONCLUSION


The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students. Based on the study results, we suggest using web-based experiential learning to supplement the traditional learning method or as the mainstream learning method for nursing students.",2020,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"['undergraduate nursing students', 'nursing students in EBP']","['web-based experiential learning program, while the control group received traditional learning with written material']","['Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence', 'practice score', 'EBP knowledge and skills score']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0182641,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"[{'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea. Electronic address: miri9912@naver.com.'}, {'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Daejeon Health Institute of Technology, Republic of Korea.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cullen', 'Affiliation': 'Department of Nursing Services and Patient Care, University of Iowa Hospitals and Clinics, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2020.104466']
2272,32454356,Benefit-cost analysis of Promoting First Relationships®: Implications of victim benefits assumptions for return on investment.,"BACKGROUND


Child abuse and neglect (CAN) cost United States society $136 billion to $428 billion annually. Preventive interventions that reduce CAN may improve people's lives and generate economic benefits to society, but their magnitude is likely to vary greatly with assumptions about victim costs avoided through intervention.
OBJECTIVE


We examined the implications of different assumptions about avoided victim costs in a benefit-cost analysis of Promoting First Relationships® (PFR), a 10-session attachment and strengths-based home visiting intervention.
PARTICIPANTS AND SETTING


Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123).
METHODS


We monetized intervention effects on out-of-home placements and implicit effects on CAN and calculated net present values under three scenarios: (1) benefits from avoided system costs, (2) additional benefits from avoided tangible victim costs, and (3) additional benefits from avoided tangible and intangible quality-of-life victim costs. For scenarios 2 and 3, we varied the CAN effect size and estimated the effect size at which PFR was reliably cost beneficial.
RESULTS


PFR's societal net benefit ranged from $1 (scenario 1) to $5514 - $25,562 (scenario 2) and $7004 - $32,072 (scenario 3) (2014 USD). In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
CONCLUSIONS


PFR is cost beneficial assuming tangible victim costs are avoided by PFR. Research into the long-term health and economic consequences of reducing CAN in at-risk populations would contribute to comprehensive, accurate benefits models.",2020,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
",['Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123'],['Promoting First Relationships®'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}]",[],,0.0284117,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Ave. NE, Suite 401, Seattle, WA 98115, United States. Electronic address: mrk63@uw.edu.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Oxford', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mloxford@uw.edu.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: spieker@uw.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Lohr', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mjlohr@uw.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Center for The Study of Health and Risk Behavior, Department of Psychiatry, University of Washington, United States. Electronic address: cnbflem@uw.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104515']
2273,32454417,Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.,"BACKGROUND


In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
METHODS


Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m 2  each on day 1, and 5-fluorouracil, 750 mg/m 2 /day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m 2 /day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m 2  of loading dose, 250 mg/m 2 /week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS.
RESULTS


A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively.
CONCLUSIONS


No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.",2020,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","['Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma', '126 TPF-ICT responders', 'laryngeal/hypopharyngeal cancer', '153 patients were enrolled', 'patients with laryngeal/hypopharyngeal cancer']","['radiotherapy (70\xa0Gy) with concurrent cisplatin', 'cisplatin-radiotherapy', 'radiotherapy', 'LEDFS', 'cetuximab', 'conventional chemoradiotherapy', 'induction chemotherapy (ICT', 'Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy', 'cisplatin', 'conventional radiotherapy, bioradiotherapy with cetuximab', 'TPF)-ICT (docetaxel and cisplatin', '5-fluorouracil, 750\xa0mg/m 2', 'docetaxel-cisplatin-5-fluorouracil', 'TPF-ICT followed by conventional chemoradiotherapy or cetuximab']","['laryngo-oesophageal dysfunction-free survival (LEDFS), LCR\xa0and OS', 'LEDFS', 'locoregional control rates (LCRs) and overall survival (OS', 'larynx preservation', 'unmanageable toxicity', 'Late grade III/IV salivary gland and laryngeal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0153398', 'cui_str': 'Malignant tumor of hypopharynx'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}]",153.0,0.178683,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Janoray', 'Affiliation': 'Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D\'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France; EA 7505, ""Education Ethique Santé"", EES, Tours, France. Electronic address: guillaume.janoray@yahoo.fr.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Clinique Sainte Catherine, Avignon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, Lorient, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bardet', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Garaud', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.009']
2274,32454458,Exercise and Academic Performance Among Children With Attention-Deficit Hyperactivity Disorder and Disruptive Behavior Disorders: A Randomized Controlled Trial.,"PURPOSE


To examine effects of a 10-week after-school physical activity (PA) program on academic performance of 6- to 12-year-old African American children with behavior problems.
METHODS


Participants were randomized to PA (n = 19) or sedentary attention control (n = 16) programs. Academic records, curriculum-based measures, and classroom observations were obtained at baseline, postintervention, and/or follow-up. Mixed models tested group × time interactions on academic records and curriculum-based measures. One-way analysis of variance or Kruskal-Wallis tested for differences in postintervention classroom observations.
RESULTS


Intent-to-treat analyses demonstrated a moderate effect within groups from baseline to postintervention on disciplinary referrals (PA: d = -0.47; attention control: d = -0.36) and a null moderate effect on academic assessments (PA: d = 0.11 to 0.36; attention control: d = 0.05 to 0.40). No significant group × time interactions emerged on direct academic assessments (all Ps ≥ .05, d = -0.23 to 0.26) or academic records (all Ps ≥ .05, d = -0.28 to 0.16). Classroom observations revealed that intervention participants were off-task due to moving at twice the rate of comparative classmates (F = 15.74, P < .001) and were off-task due to talking 33% more often (F = 1.39, P = .257).
CONCLUSION


Academic outcome improvements were small within and between groups and did not sustain at follow-up. Academic benefits of after-school PA programs for children with attention-deficit hyperactivity disorder and/or disruptive behavior disorders were smaller than neurobiological, behavioral, and cognitive outcomes as previously reported.",2020,"RESULTS


Intent-to-treat analyses demonstrated a moderate effect within groups from baseline to postintervention on disciplinary referrals (PA: d = -0.47; attention control: d = -0.36) and a null moderate effect on academic assessments (PA: d = 0.11 to 0.36; attention control: d = 0.05 to 0.40).","['Disruptive Behavior Disorders', 'children with attention-deficit hyperactivity disorder', 'Children', '6- to 12-year-old African American children with behavior problems', 'Participants were randomized to PA (n = 19) or']","['sedentary attention control', 'school PA programs', 'school physical activity (PA) program']","['academic performance', 'direct academic assessments']","[{'cui': 'C0012734', 'cui_str': 'Disruptive behavior disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0380771,"RESULTS


Intent-to-treat analyses demonstrated a moderate effect within groups from baseline to postintervention on disciplinary referrals (PA: d = -0.47; attention control: d = -0.36) and a null moderate effect on academic assessments (PA: d = 0.11 to 0.36; attention control: d = 0.05 to 0.40).","[{'ForeName': 'Jared D', 'Initials': 'JD', 'LastName': 'Ramer', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Santiago-Rodríguez', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Augusta University.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Stacy L', 'Initials': 'SL', 'LastName': 'Frazier', 'Affiliation': 'Florida International University.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Bustamante', 'Affiliation': 'University of Illinois at Chicago.'}]",Pediatric exercise science,['10.1123/pes.2019-0224']
2275,32454781,Comparative  In Vitro  and  In Vivo  Evaluation of Fenofibric Acid as an Antihyperlipidemic Drug.,"Objectives


Fenofibric acid (FA) is antihyperlipidemic agent and commercially available as a tablet formulation that weighs 840 mg for 105 mg of active substance. A new formulation with less inactive substance was developed as an alternative to the conventional formulation. The purpose of this study was to evaluate the dissolution and the relative bioavailability of the surface solid dispersion (SSD) and conventional formulations of FA by comparing them with the reference formulation in its commercial tablets. The  in vitro-in vivo  correlation among these tablet formulations was also evaluated.
Materials and Methods


The dissolution study was performed in phosphate buffer pH 6.8 and biorelevant fasted state simulated intestinal fluid. Dissolution efficiency and mean dissolution time (MDT) were used to compare the dissolution profiles. The bioavailability study, using nine healthy volunteers, was conducted based on a single-dose, fasted, randomized, crossover design. The in vivo performance was compared using the pharmacokinetic parameters C max , T max , AUC 0-72 , and AUC 0-∞ . A linear correlation model was tested using MDT and mean residence time (MRT).
Results


The results indicated that there were significant differences in the dissolution performances but no significant differences among the mean C max , T max , AUC 0-72 , or AUC 0-∞  estimated from the SSD, conventional, and reference formulations. A poor correlation was found between MRT and MDT of the three formulations.
Conclusion


The SSD formulation led to an instantaneous dissolution of the drug due to the presence of the polymer and the physical structure of the SSD. The conventional formulation could not achieve rapid dissolution despite its satisfying the requirement for immediate drug release dosage form. Both formulations could be considered bioequivalent with the reference. The  in vitro  dissolution behavior of FA using a single medium did not reflect their  in vivo  properties in the fasted condition. There was no correlation between the  in vitro  dissolution and the in vivo bioavailability of FA in this condition.",2020,"The results indicated that there were significant differences in the dissolution performances but no significant differences among the mean C max , T max , AUC 0-72 , or AUC 0-∞  estimated from the SSD, conventional, and reference formulations.",['nine healthy volunteers'],"['surface solid dispersion (SSD', 'Fenofibric acid (FA']","['MDT and mean residence time (MRT', 'mean C max , T max , AUC 0-72 , or AUC 0-∞  estimated from the SSD, conventional, and reference formulations', 'dissolution performances', 'Dissolution efficiency and mean dissolution time']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0060179', 'cui_str': 'Fenofibric acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",9.0,0.0223216,"The results indicated that there were significant differences in the dissolution performances but no significant differences among the mean C max , T max , AUC 0-72 , or AUC 0-∞  estimated from the SSD, conventional, and reference formulations.","[{'ForeName': 'Yulias Ninik', 'Initials': 'YN', 'LastName': 'Windriyati', 'Affiliation': 'Bandung Institute of Technology, School of Pharmacy, Bandung, Indonesia.'}, {'ForeName': 'Yeyet Cahyati', 'Initials': 'YC', 'LastName': 'Sumirtapura', 'Affiliation': 'Bandung Institute of Technology, School of Pharmacy, Bandung, Indonesia.'}, {'ForeName': 'Jessie Sofia', 'Initials': 'JS', 'LastName': 'Pamudji', 'Affiliation': 'Bandung Institute of Technology, School of Pharmacy, Bandung, Indonesia.'}]",Turkish journal of pharmaceutical sciences,['10.4274/tjps.galenos.2019.27147']
2276,32454794,Sitagliptin on Carotid Intima-Media Thickness in Type 2 Diabetes Mellitus Patients and Anemia: A Subgroup Analysis of the PROLOGUE Study.,"Introduction


Randomized clinical trials have not shown an additional clinical benefit of sitagliptin treatment over conventional treatment alone. However, studies of sitagliptin treatment have not examined the relationship between anemia and treatment group outcomes.
Methods


The PROLOGUE study is a prospective clinical trial of 442 participants with type 2 diabetes mellitus (T2DM) randomized to sitagliptin treatment or conventional treatment which showed no treatment differences [Estimated mean (± standard error) common carotid intima-media thickness (CIMT) was 0.827 ± 0.007 mm and 0.837 ± 0.007 mm, respectively, with a mean difference of -0.009 mm (97.2% CI -0.028 to 0.011,  p  = 0.309) at 24 mo of follow-up]. This is a post hoc subanalysis using data obtained from the PROLOGUE study; the study population was divided into anemic groups ( n  = 94) and nonanemic group ( n  = 343) based on hemoglobin level. And we analyzed for the changes in each CIMT parameter from baseline to 24 months in subgroups.
Results


The treatment group difference in baseline-adjusted mean common carotid artery- (CCA-) IMT at 24 months was -0.003 mm (95% CI -0.022 to 0.015,  p  = 0.718) in the nonanemic subgroup and -0.007 mm (95% CI -0.043 to 0.030,  p  = 0.724) in the anemic subgroup. Although there were no significant differences in the other CIMT parameters between the treatment groups in the anemic subgroup, the changes in mean and max ICA-IMT at 24 months in the nonanemic subgroup were significantly lower in the sitagliptin group than the conventional group [-0.104 mm (95% CI -0.182 to -0.026),  p  = 0.009 and -0.142 mm (-0.252 to -0.033),  p  = 0.011, respectively].
Conclusion


These data suggest that nonanemia may indicate a potentially large subgroup of those with T2DM patients that sitagliptin therapy has a better antiatherosclerotic effect than conventional therapy. Further research is needed to confirm these preliminary observations.",2020,"Although there were no significant differences in the other CIMT parameters between the treatment groups in the anemic subgroup, the changes in mean and max ICA-IMT at 24 months in the nonanemic subgroup were significantly lower in the sitagliptin group than the conventional group [-0.104 mm (95% CI -0.182 to -0.026),  ","['442 participants with type 2 diabetes mellitus (T2DM) randomized to', 'study; the study population was divided into anemic groups ( n  = 94) and nonanemic group ( n  = 343) based on hemoglobin level', 'Type 2 Diabetes Mellitus Patients and Anemia']","['Sitagliptin', 'sitagliptin treatment or conventional treatment']","['mean and max ICA-IMT', 'Carotid Intima-Media Thickness', 'baseline-adjusted mean common carotid artery- (CCA-) IMT', 'antiatherosclerotic effect', 'CIMT parameters']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",442.0,0.0841528,"Although there were no significant differences in the other CIMT parameters between the treatment groups in the anemic subgroup, the changes in mean and max ICA-IMT at 24 months in the nonanemic subgroup were significantly lower in the sitagliptin group than the conventional group [-0.104 mm (95% CI -0.182 to -0.026),  ","[{'ForeName': 'Zhengri', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Genshan', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, China.'}]",Mediators of inflammation,['10.1155/2020/8143835']
2277,32454823,"Effectiveness of a Global Multidisciplinary Supportive and Educational Intervention in Thermal Resort on Anthropometric and Biological Parameters, and the Disease-Free Survival after Breast Cancer Treatment Completion (PACThe).","A growing knowledge highlights the strong benefit of regular physical activity in the management of breast cancer patients, but few studies have considered biological parameters in their outcomes. In the prospective randomised trial after breast cancer treatment completion ""PACThe,"" we determined the effects of physical activity and nutritional intervention on the biological and anthropometric status of patients after one year of follow-up, and clarified the link between biomarkers at allocation and disease-free survival. 113 patients from the population of the ""PACThe"" study ( n  = 251) were analysed for biological parameters. Patients were randomized after chemotherapy in two arms: the intervention ""SPA"" receiving a 2-week session of physical training, dietary education, and physiotherapy ( n  = 57), and the control ""CTR"" ( n  = 56). Diet questionnaire, anthropometric measures, and blood parameters were determined at allocation and one year later. Survival and recurrence were checked over 7 years. Data were considered as a function of BMI, i.e., ≤25 for normal, 25-30 for overweight, and >30 for obese patients. At allocation, the large standard deviation for nutrient-intake values reflected an unbalanced diet for some patients in the three groups. At one-year follow-up, we noticed an increase in glucose ( p  < 10 -6 ), insulin ( p  < 10 -7 ), and adiponectin ( p  < 0.022) plasma levels for both intervention arms, which were more accentuated for the >30 groups. Using the Cox model, we demonstrated that the highest testosterone plasma values were linked to an increase of the recurrence risk (HR [CI-95%] = 5.06 [1.66-15.41];  p =0.004). One-year after a global multidisciplinary supportive and educational intervention, we found few anthropometric and biological changes, mainly related to the patient's initial BMI. We highlighted the importance of plasma testosterone in the evaluation of patient's recurrence risk. Future studies would help better understand the mechanisms by which such multidisciplinary interventions could interact with breast cancer recurrence and define the most effective modalities.",2020,"At one-year follow-up, we noticed an increase in glucose ( p  < 10 -6 ), insulin ( p  < 10 -7 ), and adiponectin ( p  < 0.022) plasma levels for both intervention arms, which were more accentuated for the >30 groups.","['breast cancer patients', '113 patients from the population of the ""PACThe"" study ( n \u2009=\u2009251']","['intervention ""SPA"" receiving a 2-week session of physical training, dietary education, and physiotherapy ( n \u2009=\u200957), and the control ""CTR', 'Global Multidisciplinary Supportive and Educational Intervention', 'physical activity and nutritional intervention']","['recurrence risk', 'adiponectin', 'Diet questionnaire, anthropometric measures, and blood parameters', 'highest testosterone plasma values', 'plasma levels', 'Survival and recurrence', 'glucose']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",251.0,0.0304833,"At one-year follow-up, we noticed an increase in glucose ( p  < 10 -6 ), insulin ( p  < 10 -7 ), and adiponectin ( p  < 0.022) plasma levels for both intervention arms, which were more accentuated for the >30 groups.","[{'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Vasson', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Nutrition, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Oncogenetics, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Rossary', 'Affiliation': 'University of Clermont Auvergne, INRA, UMR 1019 Human Nutrition Unit, CRNH-Auvergne, 28 Place Henri Dunant, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Jouvency', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Nutrition, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Oncology, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Gabriel Montpied University Hospital, Department of Sport Medicine and Functional Explorations, 58 Rue Montalembert, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Van Praagh-Doreau', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Oncology, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Travade', 'Affiliation': 'Centre République, Department of Senology, 99 Avenue de La Republique, 63100 Clermont Ferrand, France.'}, {'ForeName': 'Yves-Jean', 'Initials': 'YJ', 'LastName': 'Bignon', 'Affiliation': 'Jean Perrin Comprehensive Cancer Centre, Department of Oncogenetics, 58 Rue Montalembert, 63011 Clermont-Ferrand, France.'}]",Journal of oncology,['10.1155/2020/4181850']
2278,32454827,The Efficacy of Concentrated Growth Factor in the Healing of Alveolar Osteitis: A Clinical Study.,"Background


A dry socket also referred to as alveolar osteitis (AO) is a common postoperative complication following tooth extraction, due to the disruption of the clot within the wound. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in the healing of alveolar osteitis following tooth extraction.
Methods


The study was conducted at University Dental Hospital Sharjah, UAE. Patients undergoing tooth extraction at the oral surgery clinic were advised to return immediately if they suffer from pain. Over the following first week after tooth extraction, patients who reported pain symptoms were recalled and all dry sockets were identified. The patients were divided into two groups. Group I patients received conventional treatment with socket curettage and saline irrigation only, while in group II CGF was inserted into the socket. Both groups were observed for pain score and quantification of granulation tissue formation.
Results


A total of 40 dry socket patients, aged between 18 and 60 years, from a total of 1,250 patients, were included in the study. 30 patients were given conventional treatment while another 10 patients were given CGF. Patients who received CGF had a pain score of 7-10 at presentation, and the pain score dropped to 0-3 on day 4 and further improved to 0-1 on day 7 ( p  = 0.001). Granulation tissue formation appeared in the conventional group I on day 7 while the CGF group II showed earlier granulation tissue formation by day 4 ( p  = 0.001). The posttreatment pain score is inversely proportional to the amount and rate of granulation tissue formation in the socket.
Conclusion


The study suggests that delivery of CGF into a dry socket helps relieve pain and expedite the wound healing process as shown by a statistically much lower pain score and earlier and more rapid formation of granulation tissue when compared to the conventional alveolar osteitis therapy.",2020,Granulation tissue formation appeared in the conventional group I on day 7 while the CGF group II showed earlier granulation tissue formation by day 4 ( p  = 0.001).,"['Alveolar Osteitis', '40 dry socket patients, aged between 18 and 60 years, from a total of 1,250 patients, were included in the study', '30 patients were given conventional treatment while another 10 patients were given', 'Patients undergoing tooth extraction at the oral surgery clinic']","['concentrated growth factor (CGF', 'CGF', 'conventional treatment with socket curettage and saline irrigation', 'Concentrated Growth Factor']","['granulation tissue formation', 'Granulation tissue formation', 'pain symptoms', 'pain score', 'posttreatment pain score', 'pain score and quantification of granulation tissue formation']","[{'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0205795,Granulation tissue formation appeared in the conventional group I on day 7 while the CGF group II showed earlier granulation tissue formation by day 4 ( p  = 0.001).,"[{'ForeName': 'Aqsa', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'College of Dental Medicine, University of Sharjah, Sharjah, UAE.'}, {'ForeName': 'Basheer', 'Initials': 'B', 'LastName': 'Salman', 'Affiliation': 'College of Dental Medicine, University of Sharjah, Sharjah, UAE.'}, {'ForeName': 'Noor Hayati', 'Initials': 'NH', 'LastName': 'Abdul Razak', 'Affiliation': 'School of Dental Sciences, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Ali Al', 'Initials': 'AA', 'LastName': 'Qabbani', 'Affiliation': 'College of Dental Medicine, University of Sharjah, Sharjah, UAE.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Samsudin', 'Affiliation': 'College of Dental Medicine, University of Sharjah, Sharjah, UAE.'}]",International journal of dentistry,['10.1155/2020/9038629']
2279,32454841,The Restorative Effect of the Natural Environment on University Students' Psychological Health.,"The present study evaluated the effect of a three-week intervention aimed at improving psychological health in university students. Participants included 200 Australian students randomly assigned to an experimental or waitlist control group, with 42 adhering to intervention instructions. Participants in the experimental group read a story about someone who used the natural environment to decrease stress and burnout levels and to increase their perceived satisfaction with life. They were then instructed to spend 20 minutes each week, for three weeks, in any chosen natural environment. Waitlist control participants received intervention instructions three weeks later. Restorativeness was positively associated with life satisfaction and negatively related to stress and burnout. Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout. More research is still needed to determine the practical significance of nature exposure on university students' psychological health.",2020,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","['university students', 'Participants included 200 Australian students randomly assigned to an', ""University Students' Psychological Health""]","['experimental or waitlist control group, with 42 adhering to intervention instructions', 'Natural Environment']","['psychological health', 'stress', 'life satisfaction']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",200.0,0.0230612,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","[{'ForeName': 'Emma A', 'Initials': 'EA', 'LastName': 'Payne', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Loi', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Einar B', 'Initials': 'EB', 'LastName': 'Thorsteinsson', 'Affiliation': 'University of New England, Armidale, Australia.'}]",Journal of environmental and public health,['10.1155/2020/4210285']
2280,32454861,Effects of Massage Therapy on the Development of Babies Born with Down Syndrome.,"Objective


To determine the short-term effects of infant massage on the development of Down syndrome babies.
Materials and Methods


The study compared two groups (intervention and control), each with 16 babies with Down syndrome between 4 and 8 months old. The variables developmental age and developmental quotient were measured at two distinct time points, at pretest and after 5 weeks, using the Brunet-Lézine Early Childhood Psychomotor Development revised scale. This scale measures the variables of age and development quotient in a partial way (motor, visual-motor coordination, language, and social development) and in a global way. The experimental group received infant massage, applied by the parents, during these 5 weeks, every day for at least 10 minutes. The massage protocol was based on the methodology created by Vimala McClure. The control group received it after 5 weeks.
Results


All developmental variables were improved in the experimental group but not in the control group. There were significant differences in developmental age between the two groups, and this outcome was better in the experimental group ( p  < 0.001). The 2-by-2 mixed-model analysis of variance indicates a statistically significant group-by-time interaction for all development quotients, both partial and global ( p  < 0.001), which was significantly higher in the experimental group than in the control group.
Conclusion


Infant massage therapy improves the development of babies with Down syndrome in the short term.",2020,"There were significant differences in developmental age between the two groups, and this outcome was better in the experimental group ( p  < 0.001).","['Babies Born with Down Syndrome', '16 babies with Down syndrome between 4 and 8 months old']","['Conclusion\n\n\nInfant massage therapy', 'Massage Therapy', 'infant massage']","['babies with Down syndrome', 'partial way (motor, visual-motor coordination, language, and social development']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0695595', 'cui_str': 'Infant massage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0042828', 'cui_str': 'Visual Motor Coordination'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}]",,0.0229141,"There were significant differences in developmental age between the two groups, and this outcome was better in the experimental group ( p  < 0.001).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'María-Luisa', 'Initials': 'ML', 'LastName': 'Benítez-Lugo', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Chillón-Martínez', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rebollo-Salas', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Lorena-María', 'Initials': 'LM', 'LastName': 'Bellido-Fernández', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'José-Jesús', 'Initials': 'JJ', 'LastName': 'Jiménez-Rejano', 'Affiliation': 'Department of Physiotherapy, University of Seville, 41009 Seville, Spain.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/4912625']
2281,32454863,The Role of Xuefu Zhuyu Decoction in Prevention of Contrast-Induced Nephropathy after Percutaneous Coronary Intervention.,"Objective


This study aimed to investigate the effect of Xuefu Zhuyu decoction on preventing contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI).
Methods


A total of 256 patients undergoing selective PCI for coronary artery disease were consecutively enrolled and randomly divided into two groups: Group A ( n  = 126) and Group B ( n  = 130). Before and after PCI, all patients routinely received antiplatelet aggregation therapy, antilipidemic therapy, and hydration therapy. Besides routine therapy, patients in Group B received Xuefu Zhuyu decoction from 3 days before PCI to 3 days after PCI. Serum creatinine (Scr), estimated glomerular filtration rate (eGFR), superoxide dismutase (SOD), and malondialdehyde (MDA) were measured, respectively, at baseline (72 h before PCI) and at 24, 48, and 72 h after PCI.
Results


Compared with Group A, Group B presented a lower fluctuation of SCr and eGFR ( P  < 0.01). The incidence of CIN was less in Group B. According to the definition, CIN occurred in 5 patients (2.0%) in the intervention group and 5 (4.0%) in the control group ( P =0.167). In terms of oxidative stress, Group B had a lower MDA ( P  < 0.05), but a higher SOD ( P  < 0.05).
Conclusions


Compared with the control group, Xuefu Zhuyu decoction intervention therapy increased the level of SOD and reduced MDA. The Xuefu Zhuyu decoction intervention group presented a higher level of eGFR at 24, 48, and 72 h after PCI in patients with coronary heart disease and a lower level of Scr. The results are propitious to prove that Xuefu Zhuyu decoction might play an antioxidative stress role in the prevention of CIN after PCI.",2020,"In terms of oxidative stress, Group B had a lower MDA ( P  < 0.05), but a higher SOD ( P  < 0.05).
","['256 patients undergoing selective PCI for coronary artery disease', 'Contrast-Induced Nephropathy after Percutaneous Coronary Intervention']","['Xuefu Zhuyu decoction intervention therapy', 'Xuefu Zhuyu decoction intervention', 'Xuefu Zhuyu Decoction', 'Xuefu Zhuyu decoction', 'antiplatelet aggregation therapy, antilipidemic therapy, and hydration therapy']","['level of SOD and reduced MDA', 'contrast-induced nephropathy (CIN', 'Serum creatinine (Scr), estimated glomerular filtration rate (eGFR), superoxide dismutase (SOD), and malondialdehyde (MDA', 'fluctuation of SCr and eGFR', 'incidence of CIN', 'level of eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]","[{'cui': 'C1956470', 'cui_str': 'Xuefu Zhuyu'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",256.0,0.029319,"In terms of oxidative stress, Group B had a lower MDA ( P  < 0.05), but a higher SOD ( P  < 0.05).
","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}, {'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}, {'ForeName': 'Buyun', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Loma Linda University School of Public Health, 24951 Circle Dr, Loma Linda, CA 92354, USA.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}, {'ForeName': 'Weiliang', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang 312000, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5419016']
2282,32454920,"Perioperative Dexmedetomidine Fails to Improve Postoperative Analgesic Consumption and Postoperative Recovery in Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objectives


Dexmedetomidine is widely used as an adjunct to general anesthesia. In this study, we evaluated the effects of perioperative dexmedetomidine infusion on postoperative analgesia in patients undergoing lateral thoracotomy for thoracic esophageal cancer.
Methods


A total of 62 patients undergoing lateral thoracotomy for thoracic esophageal cancer were randomized to receive adjuvant therapy with either dexmedetomidine (0.5  μ g/kg intravenous bolus injection for 10 min before induction of anesthesia, followed by continuous infusion of 0.2-0.4  μ g/kg/h until the end of surgery, and 0.06  μ g/kg/h for 5 days after surgery) or equal volumes of saline. Acute postoperative pain was treated with patient-controlled intravenous sufentanil and flurbiprofen axetil. The primary outcomes of this study were the numbers of analgesic requirements in the first postoperative 72 h.
Results


Perioperative dexmedetomidine did not decrease the numbers of analgesic requirements in the first postoperative 72 h (dexmedetomidine group: 12.14 ± 4.76, saline group: 10.89 ± 5.66;  p =0.367). Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life. Notably, dexmedetomidine had beneficial effects on decreasing intraoperative opioid consumption and improving postoperative sleep quality.  Discussion . Perioperative dexmedetomidine has limited analgesic benefits in lateral thoracotomy for esophageal cancer when added to an opioid-based multimodal anesthetic regimen but can reduce opioid consumption.",2020,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","['62 patients undergoing lateral thoracotomy for thoracic esophageal cancer', 'Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer', 'patients undergoing lateral thoracotomy for thoracic esophageal cancer']","['Placebo', 'flurbiprofen axetil', 'sufentanil', 'Dexmedetomidine', 'Perioperative Dexmedetomidine', 'Perioperative dexmedetomidine', 'perioperative dexmedetomidine infusion', 'dexmedetomidine']","['numbers of analgesic requirements', 'total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life', 'Postoperative Analgesic Consumption and Postoperative Recovery', 'postoperative sleep quality', 'Acute postoperative pain', 'intraoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",62.0,0.395807,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Laboratory, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Life Sciences, University of Science and Technology of China, Huangshan Road 443, Hefei City, Anhui Province, China.'}, {'ForeName': 'Erwei', 'Initials': 'E', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}]",Pain research & management,['10.1155/2020/4145893']
2283,32454955,Non-surgical oral hygiene interventions on disease activity of Rheumatoid arthritis patients with periodontitis: A randomized controlled trial.,"Background.  Periodontitis and rheumatoid arthritis have similar epidemiology and pathophysiology. Understanding the interaction between these two diseases is vital in our settings. We set out to assess the effect of oral hygiene interventions on disease activity of rheumatoid arthritis patients with periodontitis in Kampala, Uganda.  Methods.  Fifty-eight patients attending an arthritis clinic with rheumatoid arthritis and periodontitis were randomly assigned to either an intervention group or a control group. Patients diagnosed with rheumatoid arthritis at least two years before, who were on the same medication, dose, or formulation for RA treatment during the preceding three months, were included. The patients were >18 years of age, would be available for all the study visits in the next six months, had at least six natural teeth, had periodontal disease classified as Dutch Periodontal Index (DPSI) >3 and provided written informed consent. Those who had a chronic disorder requiring chronic or intermittent use of antibiotics, were pregnant, were lactating, or had intent to become pregnant were excluded. The primary outcome measure was a change in Disease Activity Score of 28 Joints (DAS28 score) in two 3-month follow-up periods after the intervention. The secondary outcome measure was a change in periodontal status.  Results.  There was a statistically significant improvement in the DAS-28 score in both the intervention and control arms during the follow-up period (P<0.01). The participants carrying more than one bacterial species had worse DAS-28 scores.  Conclusion.  Oral hygiene interventions given to RA patients could drastically improve their RA treatment outcomes, especially in resource-limited settings.",2020,There was a statistically significant improvement in the DAS-28 score in both the intervention and control arms during the follow-up period (P<0.01).,"['patients were >18 years of age, would be available for all the study visits in the next six months, had at least six natural teeth, had periodontal disease classified as Dutch Periodontal Index (DPSI) >3 and provided written informed consent', 'Patients diagnosed with rheumatoid arthritis at least two years before, who were on the same medication, dose, or formulation for RA treatment during the preceding three months, were included', 'Rheumatoid arthritis patients with periodontitis', 'rheumatoid arthritis patients with periodontitis in Kampala, Uganda.  Methods', 'Fifty-eight patients attending an arthritis clinic with rheumatoid arthritis and periodontitis', 'Those who had a chronic disorder requiring chronic or intermittent use of antibiotics, were pregnant, were lactating, or had intent to become pregnant were excluded']","['surgical oral hygiene interventions', 'oral hygiene interventions']","['disease activity', 'change in periodontal status', 'DAS-28 score', 'change in Disease Activity Score of 28 Joints (DAS28 score', 'DAS-28 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0031092', 'cui_str': 'Periodontal Indexes'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",58.0,0.0504929,There was a statistically significant improvement in the DAS-28 score in both the intervention and control arms during the follow-up period (P<0.01).,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Buwembo', 'Affiliation': 'Department of Human Anatomy, School of Biomedical Sciences, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Ian Guyton', 'Initials': 'IG', 'LastName': 'Munabi', 'Affiliation': 'Department of Human Anatomy, School of Biomedical Sciences, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kaddumukasa', 'Affiliation': 'Department of Medicine, School of Medicine, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Kiryowa', 'Affiliation': 'Department of Human Anatomy, School of Biomedical Sciences, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mbabali', 'Affiliation': 'Department of Dentistry, School of Health Sciences, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Nankya', 'Affiliation': 'Division of Computational Biomedicine, Boston University School of Medicine, Boston, MA, Boston University, USA.'}, {'ForeName': 'William Evan', 'Initials': 'WE', 'LastName': 'Johnson', 'Affiliation': 'Division of Computational Biomedicine, Boston University School of Medicine, Boston, MA, Boston University, USA.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Department of Medicine, School of Medicine, Makerere University College of Health Sciences, Kampala Uganda.'}, {'ForeName': 'Nelson K', 'Initials': 'NK', 'LastName': 'Sewankambo', 'Affiliation': 'Department of Medicine, School of Medicine, Makerere University College of Health Sciences, Kampala Uganda.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.004']
2284,32454959,Comparison of dual-dimensional and rectangular wires in terms of space closure and anchorage loss during retraction with miniimplants: A prospective clinical study.,"Background.  In sliding mechanics, archwires should slide easily during the retraction of anteriors. Round wires slide well, but the torque control is a significant problem. Rectangular wires produce effective torque expression but pose a challenge to free sliding due to factors like friction and force used to overcome friction, etc. To utilize the properties of both wires, the wire should be bi-dimensional. Dual-dimensional wire is one such wire with different dimensions in the anterior and posterior sections. This study aimed to compare the amount of space closure and anchorage loss of molars between the rectangular and dual-dimensional wire groups during retraction with mini-implants.  Methods.  Forty patients were randomly allocated to two groups (n=20). Patients with rectangular wires formed the control group, and those with dual-dimensional wires formed the experimental group. Mini-implants and NiTi coil springs were used for retraction. Model and cephalometric analyses were carried out to calculate the amount of space closure and anchor loss, before and four months after the study. Statistical significance was set at P<0.05.  Results.  The average amount of space closure was higher with DDW (3.98 mm) than rectangular wire (3.22 mm). The difference was statistically significant. No significant difference was found with anchorage loss.  Conclusion.  DDW can be used as an alternative to rectangular wires during retraction with mini-implants; however, it cannot replace the rectangular wires completely. Anchorage control was effective with both wires.",2020,The average amount of space closure was higher with DDW (3.98 mm) than rectangular wire (3.22 mm).,['Forty patients'],"['Mini-implants and NiTi coil springs', 'dual-dimensional and rectangular wires']","['average amount of space closure', 'anchorage loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009249', 'cui_str': 'Coiled Spring'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205142', 'cui_str': 'Rectangular'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",40.0,0.0165679,The average amount of space closure was higher with DDW (3.98 mm) than rectangular wire (3.22 mm).,"[{'ForeName': 'Sangeetha Morekonda', 'Initials': 'SM', 'LastName': 'Gnaneswar', 'Affiliation': 'Department of Orthodontics, SRM Dental College, SRM University, Ramapuram, Chennai India.'}, {'ForeName': 'Premkumar', 'Initials': 'P', 'LastName': 'Sridhar', 'Affiliation': 'Department of Orthodontics, Tamilnadu Govt. Dental College, Park Town, Chennai India.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.008']
2285,32454960,Performance of fissure sealants on fully erupted permanent molars with incipient carious lesions: A glass-ionomer-based versus a resin-based sealant.,"Background.  The effectiveness of fissure sealants in caries prevention depends on their long-term retention and ability to stop caries progression. This randomized controlled clinical trial compared the retention rate and cariostatic properties of a contemporary glass-ionomer-based sealant (GIS) versus a resin-based sealant (RS) placed on fully erupted permanent molars in a split-mouth design.  Methods.  The sealants were placed on fully erupted permanent teeth (8‒12 years of age) in 45 children. The evaluation was conducted after one week and three and six months.  Results.  There was a statistically significant difference in the retention rate and caries transition between the two groups over a six-month clinical evaluation period. The resin-based sealant group showed a better retention rate than the GIS group (75.56% and 48.88%, respectively). The resin-based sealant was superior to GIS in preventing caries progression.  Conclusion.  Resin-based fissure sealant with fluoride releasing properties might be preferable in preventing caries progression of incipient non-cavitated carious lesions in fully-erupted teeth.",2020,There was a statistically significant difference in the retention rate and caries transition between the two groups over a six-month clinical evaluation period.,['fully erupted permanent molars with incipient carious lesions'],"['contemporary glass-ionomer-based sealant (GIS) versus a resin-based sealant (RS', 'fissure sealants', 'resin-based sealant']","['retention rate and caries transition', 'retention rate']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205256', 'cui_str': 'Incipient'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",45.0,0.0476839,There was a statistically significant difference in the retention rate and caries transition between the two groups over a six-month clinical evaluation period.,"[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Jaafar', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Beirut Arab University, Lebanon.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Ragab', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, Beirut Arab University, Lebanon.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abedrahman', 'Affiliation': 'Department of Pediatric Dentistry and Dental Public Health, Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Alexandria University, Egypt.'}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Osman', 'Affiliation': 'Department of Dental Materials, Faculty of Dentistry, Beirut Arab University, Lebanon.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.009']
2286,32455002,Effects of Cashew Nut ( Anacardium occidentale  L.) Seed Flour in Moderately Malnourished Children: Randomized Clinical Trial.,"The monitoring and combined use of dietary supplements to restore adequate growth are paramount and highly recommended in child malnutrition, an important public health problem. The objective of this study was to analyze the effects of cashew nut seed flour in children with moderate malnutrition, treated at primary healthcare services. This is a randomized clinical trial conducted from April to October 2017 in the city of Imperatriz, Brazil. The sample comprised 30 children born at term, aged between 2 and 5 years, and newly diagnosed with malnutrition (60 days or less), randomized into experimental and control groups. The intervention consisted of daily intake of cashew nut seed flour. There was intragroup statistically significant difference in the glucose levels of children who were assigned to the control group ( p =0.02) and in the glycated hemoglobin in the experimental group ( p  < 0.01). Intergroup analysis of glycated hemoglobin levels showed statistically significant differences in favor of the experimental group ( p =0.01). HDL and LDL had, respectively, increased and decreased in the experimental group. The use of cashew nut seed flour in a 24-week period had positive effects on glycated hemoglobin, HDL, and LDL parameters in moderately malnourished children.",2020,Intergroup analysis of glycated hemoglobin levels showed statistically significant differences in favor of the experimental group ( p =0.01).,"['April to October 2017 in the city of Imperatriz, Brazil', 'Moderately Malnourished Children', 'children with moderate malnutrition, treated at primary healthcare services', '30 children born at term, aged between 2 and 5\u2009years, and newly diagnosed with malnutrition (60\u2009days or less', 'moderately malnourished children']","['Cashew Nut ( Anacardium occidentale  L', 'cashew nut seed flour', 'dietary supplements', 'Seed Flour', 'daily intake of cashew nut seed flour']","['glucose levels', 'glycated hemoglobin', 'glycated hemoglobin, HDL, and LDL parameters', 'glycated hemoglobin levels']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0459815', 'cui_str': 'Cashew nut'}, {'cui': 'C0330953', 'cui_str': 'Anacardium occidentale'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",30.0,0.0525396,Intergroup analysis of glycated hemoglobin levels showed statistically significant differences in favor of the experimental group ( p =0.01).,"[{'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Pereira de Jesus Costa', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Mércia', 'Initials': 'M', 'LastName': 'Kelly Dos Santos Silva', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Samae', 'Initials': 'S', 'LastName': 'Batista de Oliveira', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Luana Leite', 'Initials': 'LL', 'LastName': 'Silva', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Alessandra Cruz', 'Initials': 'AC', 'LastName': 'Silva', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Raidanes Barros', 'Initials': 'RB', 'LastName': 'Barroso', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'José de Ribamar', 'Initials': 'JR', 'LastName': 'Macedo Costa', 'Affiliation': 'Food Engineering Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Virlane Kelly', 'Initials': 'VK', 'LastName': 'Lima Hunaldo', 'Affiliation': 'Food Engineering Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Marcelino Santos', 'Initials': 'MS', 'LastName': 'Neto', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Lívia Maia', 'Initials': 'LM', 'LastName': 'Pascoal', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Márcia Caroline', 'Initials': 'MC', 'LastName': 'Nascimento Sá Ewerton Martins', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Floriacy Stabnow', 'Initials': 'FS', 'LastName': 'Santos', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Hunaldo Dos Santos', 'Affiliation': 'Natural Sciences Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Gledson Weslley', 'Initials': 'GW', 'LastName': 'Pereira Santos', 'Affiliation': 'Physical Education Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Alves de Oliveira Serra', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Ariadne', 'Initials': 'A', 'LastName': 'Siqueira de Araújo Gordon', 'Affiliation': 'Nursing Department, Maranhão Federal University, University Avenue, S/N, Imperatriz, MA, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Moura de Araújo', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, José Franco de Oliveira Street, S/N, Redenção, CE, Brazil.'}, {'ForeName': 'Márcio Flávio Moura', 'Initials': 'MFM', 'LastName': 'de Araújo', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, José Franco de Oliveira Street, S/N, Redenção, CE, Brazil.'}]",Journal of nutrition and metabolism,['10.1155/2020/6980754']
2287,32455108,The therapeutic efficacy of Qigong exercise on the main symptoms of fibromyalgia: A pilot randomized clinical trial.,"Background


Some of the most debilitating symptoms of fibromyalgia (FM) include widespread chronic pain, sleep disturbances, chronic fatigue, anxiety, and depression. Yet, there is a lack of effective self-management exercise interventions capable of alleviating FM symptoms. The objective of this study is to examine the efficacy of a 10-week daily Qigong, a mind-body intervention program, on FM symptoms.
Methods


20 participants with FM were randomly assigned to Qigong (experimental) or sham-Qigong (control) groups, with participants blinded to the intervention allocation. The Qigong group practiced mild body movements synchronized with deep diaphragmatic breathing and meditation. The sham-Qigong group practiced only mild body movements. Both groups practiced the interventions two times per day at home, plus one weekly group practice session with a Qigong instructor. Primary outcomes were: pain changes measured by the Short-Form McGill Pain Questionnaire, a visual analog scale for pain, pressure pain threshold measured by a dolorimeter. Secondary outcomes were: the Revised Fibromyalgia Impact Questionnaire the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale and the Quality of Life Scale.
Results


The experimental group experienced greater clinical improvements when compared to the control group on the mean score differences of pain, sleep quality, chronic fatigue, anxiety, depression, and fibromyalgia impact, all being statistically significant at  p  < 0.05.
Conclusion


Daily practice of Qigong appears to have a positive impact on the main fibromyalgia symptoms that is beyond group interaction.
Trial registration


ClinicalTrials.gov NCT03441997.",2020,"The experimental group experienced greater clinical improvements when compared to the control group on the mean score differences of pain, sleep quality, chronic fatigue, anxiety, depression, and fibromyalgia impact, all being statistically significant at  p  < 0.05.
","['20 participants with FM', 'fibromyalgia']","['Qigong group practiced mild body movements synchronized with deep diaphragmatic breathing and meditation', 'Qigong (experimental) or sham-Qigong (control', 'Qigong exercise', 'sham-Qigong group practiced only mild body movements']","['mean score differences of pain, sleep quality, chronic fatigue, anxiety, depression, and fibromyalgia impact', 'pain changes measured by the Short-Form McGill Pain Questionnaire, a visual analog scale for pain, pressure pain threshold measured by a dolorimeter', 'Revised Fibromyalgia Impact Questionnaire the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale and the Quality of Life Scale']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",20.0,0.124597,"The experimental group experienced greater clinical improvements when compared to the control group on the mean score differences of pain, sleep quality, chronic fatigue, anxiety, depression, and fibromyalgia impact, all being statistically significant at  p  < 0.05.
","[{'ForeName': 'Caio V M', 'Initials': 'CVM', 'LastName': 'Sarmento', 'Affiliation': 'Department of Physical Therapy, California State University, Fresno, CA, United States.'}, {'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Smirnova', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Colgrove', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Sue Min', 'Initials': 'SM', 'LastName': 'Lai', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States.'}]",Integrative medicine research,['10.1016/j.imr.2020.100416']
2288,32455120,Efficacy of internet-delivered cognitive behavioural therapy following an acute coronary event: A randomized controlled trial.,"Depression and anxiety are common among people who have experienced an acute coronary event (e.g., heart attack). Multidisciplinary cardiac rehabilitation programs often focus on reducing risk factors associated with future cardiac events, however, mental health interventions are not routinely available. Given known difficulties with access to mental health treatment, the present study sought to explore the efficacy and acceptability of an Internet-delivered cognitive behavioural therapy program ( Cardiac Wellbeing Course ) among participants who experienced an acute coronary event. The five-lesson course was delivered over eight weeks and was provided with brief weekly contact, via telephone and secure email with a guide. Participants were randomized to the  Cardiac Wellbeing Course  ( n  = 25) or waiting-list control group ( n  = 28). Symptoms were assessed at pre-treatment, post-treatment, and four-week follow-up. Completion rates (84%) and satisfaction ratings (95%) were high. Statistically significant between-group improvements were observed for the treatment group on primary measures of general anxiety (Cohen's  d  = 1.62; 67% reduction), depression (Cohen's  d  = 1.09; 61% reduction), and physical activity levels (Cohen's  d  = 0.27; 70% increase). Statistically significant improvements were also observed on secondary measures of distress (Cohen's  d  = 0.98; 51% reduction), cardiac anxiety (Cohen's  d  = 0.92; 34% reduction), and mental-health quality of life (Cohen's  d  = 0.23; 24% improvement). The changes were maintained at four-week follow-up. The current findings add to the existing literature and highlight the potential of Internet-delivered cognitive behavioural therapy programs among participants who have experienced an acute coronary event.",2020,"Statistically significant between-group improvements were observed for the treatment group on primary measures of general anxiety (Cohen's  d  = 1.62; 67% reduction), depression (Cohen's  d  = 1.09; 61% reduction), and physical activity levels (Cohen's  d  = 0.27; 70% increase).","['acute coronary event', 'participants who experienced an acute coronary event', 'participants who have experienced an acute coronary event', 'people who have experienced an acute coronary event (e.g., heart attack']","['Cardiac Wellbeing Course  ( n \xa0=\xa025) or waiting-list control group', 'internet-delivered cognitive behavioural therapy', 'Internet-delivered cognitive behavioural therapy program ( Cardiac Wellbeing Course ']","['satisfaction ratings', 'Completion rates', 'secondary measures of distress', 'mental-health quality of life', 'general anxiety', 'depression', 'cardiac anxiety', 'Depression and anxiety', 'efficacy and acceptability', 'physical activity levels']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.03896,"Statistically significant between-group improvements were observed for the treatment group on primary measures of general anxiety (Cohen's  d  = 1.62; 67% reduction), depression (Cohen's  d  = 1.09; 61% reduction), and physical activity levels (Cohen's  d  = 0.27; 70% increase).","[{'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Schneider', 'Affiliation': '3737 Wascana Parkway, Department of Psychology, University of Regina, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Hadjistavropoulos', 'Affiliation': '3737 Wascana Parkway, Department of Psychology, University of Regina, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'eCentreClinic, Department of Psychology, Macquarie University, Balaclava Road, North Ryde, NSW 2109, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'eCentreClinic, Department of Psychology, Macquarie University, Balaclava Road, North Ryde, NSW 2109, Australia.'}]",Internet interventions,['10.1016/j.invent.2020.100324']
2289,32455149,The effects of vitamin K-rich green leafy vegetables on bone metabolism: A 4-week randomised controlled trial in middle-aged and older individuals.,"Background


High vegetable intake is associated with beneficial effects on bone. However, the mechanisms remain uncertain. Green leafy vegetables are a rich source of vitamin K1, which is known to have large effects on osteoblasts and osteocalcin (OC) metabolism.
Objective


To examine the effects of consumption of two to three extra serves of green leafy vegetables daily on bone metabolism.
Methods


Thirty individuals (mean age 61.8 ± 9.9 years, 67% male) completed three experimental phases in a randomised controlled crossover design, each lasting four weeks, with a washout period of four weeks between phases (clinical trial registration: ACTRN12615000194561). The three experimental phases were: (i) increased dietary vitamin K1 by consuming green leafy vegetables (H-K; ~200 g/d containing 164.3 [99.5-384.7] μg/d of vitamin K1); (ii) low vitamin K1 by consuming vitamin K1-poor vegetables (L-K; ~200 g/d containing 9.4 [7.7-11.6] μg/d of vitamin K1); and (iii) control (CON) where participants consumed an energy-matched non-vegetable control. OC forms, total OC (tOC), carboxylated OC (cOC) and undercarboxylated OC (ucOC), were measured in serum pre- and post-intervention for each experimental phase using a sandwich-electrochemiluminescence immunoassay.
Results


Pre-intervention tOC, ucOC and ucOC:tOC levels were similar between phases ( P  > .05). Following H-K, but not L-K, tOC, ucOC and ucOC:tOC levels were significantly lower compared to pre-intervention levels ( P  ≤ .001) and compared to CON (~14%, 31% and 19%, respectively, all  P  < .05), while cOC remained unchanged.
Conclusions


In middle-aged healthy men and women, an easily achieved increase in dietary intake of vitamin K1-rich green leafy vegetables substantially reduces serum tOC and ucOC suggesting increased entry of OC into bone matrix, where it may improve the material property of bone. In conjunction with previous epidemiological and randomised controlled trial data, these findings suggest that interventions to increase vegetable intake over extended periods should include bone end points including fracture risk.",2020,"Following H-K, but not L-K, tOC, ucOC and ucOC:tOC levels were significantly lower compared to pre-intervention levels ( P  ≤ .001) and compared to CON (~14%, 31% and 19%, respectively, all  P  < .05), while cOC remained unchanged.
","['middle-aged healthy men and women', 'Methods\n\n\nThirty individuals (mean age 61.8\xa0±\xa09.9\xa0years, 67% male', 'middle-aged and older individuals']","['vitamin K1); (ii) low vitamin K1 by consuming vitamin K1-poor vegetables', 'vitamin K-rich green leafy vegetables', 'CON', 'vitamin K1); and (iii) control (CON) where participants consumed an energy-matched non-vegetable control']","['tOC levels', 'ucOC and ucOC', 'tOC, ucOC and ucOC:tOC levels', 'dietary vitamin K1', 'OC forms, total OC (tOC), carboxylated OC (cOC) and undercarboxylated OC (ucOC', 'bone metabolism', 'osteoblasts and osteocalcin (OC) metabolism']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0031862', 'cui_str': 'Vitamin K 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031862', 'cui_str': 'Vitamin K 1'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0029418', 'cui_str': 'Osteoblast'}]",,0.0981331,"Following H-K, but not L-K, tOC, ucOC and ucOC:tOC levels were significantly lower compared to pre-intervention levels ( P  ≤ .001) and compared to CON (~14%, 31% and 19%, respectively, all  P  < .05), while cOC remained unchanged.
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Prince', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Levinger', 'Affiliation': 'Institute for Health and Sport (iHeS), Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Brennan-Speranza', 'Affiliation': 'Department of Physiology, Bosch Institute for Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ward', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, The University Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'Department of Clinical Biochemistry, PathWest Laboratory Medicine, Queen Elizabeth II Medical Centre, Perth, Australia.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, The University Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Science, Royal Perth Hospital Unit, The University Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}]",Bone reports,['10.1016/j.bonr.2020.100274']
2290,32455172,Corifollitropin alfa versus follitropin beta: an economic analysis alongside a randomized controlled trial in women undergoing IVF/ICSI.,"This cost-effectiveness analysis was conducted from the patient's perspective alongside a randomized controlled trial comparing corifollitropin alfa with follitropin beta for a single stimulation cycle. Only unit costs paid by patients are included in this analysis. The incremental cost-effectiveness ratio was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were also performed. Baseline characteristics (except for the number of follicles and frozen embryos), treatment outcomes and complications were similar in the two groups. The live birth rate was comparable between the two groups, but the mean total cost per patient was higher for the corifollitropin alfa strategy (€4293) compared with the follitropin beta strategy (€4086). Costs per live birth were €13,726 and €12,511, respectively. The difference in effect between corifollitropin alfa and collitropin beta was three fewer live births, and the difference in costs was €24,048. The probability of live birth after the first and second embryo transfers and the proportion of patients who had no more frozen embryos available after non-achievement of live birth in the first or second transfer influenced the comparative cost-effectiveness of the two strategies. PSA showed that a corifollitropin alfa strategy would be rejected in up to 27.4% of scenarios. Follitropin beta 300 IU/day was more cost-effective than corifollitropin alfa 150 μg in women aged 35-42 years weighing ≥ 50 kg undergoing in-vitro fertilzation/intracytoplasmic sperm injection.",2020,Follitropin beta 300 IU/day was more cost-effective than corifollitropin alfa 150 μg in women aged 35-42 years weighing ≥ 50 kg undergoing in-vitro fertilzation/intracytoplasmic sperm injection.,"['150 μg in women aged 35-42 years weighing ≥\xa050 kg undergoing in-vitro fertilzation/intracytoplasmic sperm injection', 'women undergoing IVF/ICSI']","['corifollitropin alfa', 'Follitropin', 'Corifollitropin alfa versus follitropin beta', 'corifollitropin alfa with follitropin beta']","['Costs per live birth', 'incremental cost-effectiveness ratio', 'mean total cost per patient', 'live birth rate', 'probability of live birth', 'cost-effective']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C2713522', 'cui_str': 'corifollitropin alfa'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0060787', 'cui_str': 'follitropin beta'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.230415,Follitropin beta 300 IU/day was more cost-effective than corifollitropin alfa 150 μg in women aged 35-42 years weighing ≥ 50 kg undergoing in-vitro fertilzation/intracytoplasmic sperm injection.,"[{'ForeName': 'Le Dang', 'Initials': 'LD', 'LastName': 'Khoa', 'Affiliation': 'Hope Research Centre, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vuong Thi Ngoc', 'Initials': 'VTN', 'LastName': 'Lan', 'Affiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Minh Tai', 'Initials': 'NMT', 'LastName': 'Loc', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dang Quang', 'Initials': 'DQ', 'LastName': 'Vinh', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Quang Nhat', 'Initials': 'QN', 'LastName': 'Tran', 'Affiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ho Manh', 'Initials': 'HM', 'LastName': 'Tuong', 'Affiliation': 'Hope Research Centre, Ho Chi Minh City, Vietnam.'}]",Reproductive biomedicine & society online,['10.1016/j.rbms.2020.01.002']
2291,32455486,Dermoscopy comparative approach for early diagnosis in familial melanoma: influence of MC1R genotype.,"BACKGROUND


MC1R polymorphisms interact with CDKN2A mutations modulating melanoma risk and contribute to a less suspicious clinical and dermoscopic appearance of melanomas. Different strategies, including dermoscopic comparative approach and digital monitoring, are used for the melanoma diagnosis in this context.
OBJECTIVE


To analyse the diagnostic accuracy of the morphologic approach and comparative approach in dermoscopy, to detect melanoma in familial melanoma (FamMM) patients according to different genetic backgrounds.
METHODS


Two independent readers evaluated 415 lesions belonging to 25 FamMM: 26 melanomas (62% in situ, 36% early invasive) and 389 nevi, blinded for dermoscopic and histopathologic diagnosis, following two different steps. First step-Randomized: all lesions were randomly located in one single folder. Second step-Comparative approach: the lesions were clustered by patient. Sensitivity, specificity, and number needed to excise (NNE) for melanoma diagnosis were calculated for both diagnostic strategies. Sensitivity and specificity were also assessed regarding the genetic background.
RESULTS


The comparative approach showed lower sensitivity compared to the morphologic approach (69.2 and 73.1 vs. 76.9 both readers) but better specificity (95.9 and 95.1 vs. 84.3 and 90.2, respectively). NNE was better in the comparative approach. The readers had more difficulties diagnosing lesions from CDKN2A mutation carriers with red hair colour (RHC) MC1R variants.
CONCLUSION


The comparative approach can be useful in high risk patients to decrease the NNE. Early melanomas in CDKN2A carriers with RHC polymorphisms are more difficult to diagnose even with the comparative approach and benefit from the detection of changes during digital dermoscopy monitoring for early diagnosis.",2020,Early melanomas in CDKN2A carriers with RHC polymorphisms are more difficult to diagnose even with the comparative approach and benefit from the detection of changes during digital dermoscopy monitoring for early diagnosis.,"['Two independent readers evaluated 415 lesions belonging to 25 FamMM', 'familial melanoma (FamMM) patients according to different genetic backgrounds', 'Early melanomas in CDKN2A carriers with RHC polymorphisms', 'early diagnosis in familial melanoma', '26 melanomas (62% in situ, 36% early invasive) and 389 nevi, blinded for dermoscopic and histopathologic diagnosis']",[],"['lower sensitivity', 'Sensitivity, specificity, and number needed to excise (NNE) for melanoma diagnosis', 'Sensitivity and specificity']","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0151779', 'cui_str': 'Malignant melanoma of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042916', 'cui_str': 'Genetic Background'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0384826', 'cui_str': 'p14ARF Protein'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0239803', 'cui_str': 'Red hair'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0027960', 'cui_str': 'Nevi'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0603168,Early melanomas in CDKN2A carriers with RHC polymorphisms are more difficult to diagnose even with the comparative approach and benefit from the detection of changes during digital dermoscopy monitoring for early diagnosis.,"[{'ForeName': 'Authors C', 'Initials': 'AC', 'LastName': 'Longo', 'Affiliation': 'Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Barquet', 'Affiliation': 'Dermatology Department, Hospital de Clínicas, Montevideo, Uruguay.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hernandez', 'Affiliation': ""Dermatology Department, Hospital Universitary Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Marghoob', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Potrony', 'Affiliation': 'Dermatology Department, Melanoma Unit, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carrera', 'Affiliation': 'Dermatology Department, Melanoma Unit, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aguilera', 'Affiliation': 'Dermatology Department, Melanoma Unit, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Badenas', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Malvehy', 'Affiliation': 'Dermatology Department, Melanoma Unit, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Dermatology Department, Melanoma Unit, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16679']
2292,32455493,Standardization for reliable uroflowmetry testing in adults.,"OBJECTIVES


To assess if a standard hydration protocol will achieve voided volumes over 150 mL and more reliable uroflowmetry results.
METHODS


This is a single-blinded crossover study of 40 patients with benign prostatic obstruction and 34 healthy volunteers. Subjects were enrolled prospectively between January and March 2019. All subjects performed two randomly ordered uroflowmetry tests. One test was performed when subjects sensed their bladder was full and had the urge to void and another one after emptying the bladder and ingesting 1.5 L of water within 1 hour (prehydration). Uroflowmetry parameters were compared between the benign prostatic obstruction group and the healthy volunteers. Uroflowmetry results were categorized as reliable, residual, and suboptimal with respect to voided volumes. This study has been registered in the UMIN Clinical Trials Registry (UMIN000035446).
RESULTS


The benign prostatic obstruction group and the healthy volunteer group presented no difference in respect of uroflowmetry test reliability (P = .459). Uroflowmetry results were reliable in 58 (78.4%) subjects in the prehydrated group and was reliable in 30 (40.5%) subjects in the non-prehydrated group. The difference was statistically significant (P < .05). In the benign prostatic obstruction group and healthy volunteer group, the rate of reliable uroflowmetry tests was significantly higher with prehydration (P < .05). The comparative analysis of uroflowmetry parameters between tests performed with and without prehydration revealed higher values in the prehydrated group (voided volume, maximum flow rate, average flow rate, and postvoiding residual volume; P < .05).
CONCLUSION


Prehydration of patients with 1.5 L of water within 1 hour before uroflowmetry improves uroflowmetry outcomes. By this hydration protocol, the chance to obtain a voided volume over 150 mL is increased significantly.",2020,"In the benign prostatic obstruction group and healthy volunteer group, the rate of reliable uroflowmetry tests was significantly higher with prehydration (P < .05).","['40 patients with benign prostatic obstruction and 34 healthy volunteers', 'adults', 'Subjects were enrolled prospectively between January and March 2019']",[],"['uroflowmetry test reliability', 'rate of reliable uroflowmetry tests', 'uroflowmetry outcomes', 'Uroflowmetry parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.0207373,"In the benign prostatic obstruction group and healthy volunteer group, the rate of reliable uroflowmetry tests was significantly higher with prehydration (P < .05).","[{'ForeName': 'Erman', 'Initials': 'E', 'LastName': 'Ceyhan', 'Affiliation': 'Department of Urology, Baskent University Konya Hospital, Konya, Turkey.'}, {'ForeName': 'Mehmet K', 'Initials': 'MK', 'LastName': 'Asutay', 'Affiliation': 'Department of Urology, Sanliurfa Training and Research Hospital, Sanliurfa, Turkey.'}]",Lower urinary tract symptoms,['10.1111/luts.12323']
2293,32455501,Characteristics of three different patellar implant designs in total knee arthroplasty.,"BACKGROUND


Despite debate over the role of patellar resurfacing in total knee arthroplasty, many surgeons feel it decreases re-operation rates and anterior pain, and an increasing number are adopting resurfacing. This study compares intra-operative characteristics of different patellar implants to assist surgeons in gaining better understanding of these implants.
METHODS


The three most commonly used patellar implants (inset, onlay round and onlay oval) were allocated randomly to 120 patients undergoing total knee arthroplasty. We compared the groups in terms of implant size, bone coverage, lateral underhang (uncovered lateral facet) and need for partial lateral facetectomy. We also compared the patient-reported outcome measures between the groups at 6 months post-operatively.
RESULTS


The inset, onlay round and onlay oval designs had bone coverage of 48.5%, 65.9% and 85.9%, respectively (P < 0.01). Similarly, the onlay-oval implant was found to have the smallest lateral underhang of all three designs (inset 11.6 mm; onlay round 6.9 mm, onlay oval 1.6 mm, P < 0.01). The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01). In addition, patellae using onlay-oval implants required significantly fewer lateral facetectomies due to improved bone coverage (inset 95%; onlay round 87%; onlay oval 3%; P < 0.01). Finally, comparison of patient-reported outcome measures between the groups showed no difference at an early assessment of 6 months.
CONCLUSION


Onlay-oval design allows for the use of a larger implant, improving bone coverage and reducing the need for partial lateral facetectomy; however, early assessment of outcomes shows no difference between the three designs.",2020,"The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01).","['total knee arthroplasty', '120 patients undergoing total knee arthroplasty']",['patellar resurfacing'],"['bone coverage', 'lateral facetectomies']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0546528', 'cui_str': 'Facetectomy'}]",120.0,0.0658765,"The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01).","[{'ForeName': 'Monther A', 'Initials': 'MA', 'LastName': 'Gharaibeh', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Chen', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jil A', 'Initials': 'JA', 'LastName': 'Wood', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15988']
2294,32455547,"Exercise Training, Intermittent Fasting and Alkaline Supplementation as an Effective Strategy for Body Weight Loss: A 12-Week Placebo-Controlled Double-Blind Intervention with Overweight Subjects.","BACKGROUND


Intermittent fasting (IF) combined with exercise has been suggested to enhance weight loss. However, both procedures might negatively influence acid-base status. The aim of this study was to determine the combined effects of IF, exercise training and alkaline supplementation in overweight subjects on body composition and running performance.
METHODS


80 overweight subjects of age 45.5 ± 7.8 years were assigned to IF or non-intermittent fasting (nIF). Furthermore, subjects were randomly assigned to take either an alkaline supplement (IF-v, nIF-v) or a placebo (IF-p, nIF-p) twice a day. All subjects performed a personalized endurance exercise program (3-4 times/week for 12 weeks). Body weight, body composition, running performance and acid-base parameters were determined before (pre) and after the 12-week program (post).
RESULTS


68 participants completed the study. There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements. Body weight decreased in all groups (IF-p: -5.80 ± 0.77 kg and nIF-p: -3.40 ± 0.58 kg; IF-v: -8.28 ± 0.75 kg and nIF-v: -5.59 ± 0.87 kg). In both dietary strategies, weight loss was significantly further enhanced by alkaline supplementation. The increase in running velocity was significantly higher in IF combined with alkaline supplementation (IF-v 1.73 ± 0.23 km/h and IF-p 0.97 ± 0.20 km/h). In addition, alkaline supplementation increased plasma HCO 3 -  concentration and urinary pH.
CONCLUSION


Exercise training in combination with IF and alkaline supplementation is an effective strategy to reduce body weight and improve running performance in a 12-week intervention.",2020,"There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements.","['overweight subjects on body composition and running performance', '68 participants completed the study', 'Overweight Subjects', '80 overweight subjects of age 45.5 ± 7.8 years']","['alkaline supplementation', 'personalized endurance exercise program', 'IF or non-intermittent fasting (nIF', 'alkaline supplement (IF-v, nIF-v) or a placebo', 'Placebo-Controlled Double-Blind Intervention', 'Exercise Training, Intermittent Fasting and Alkaline Supplementation', 'exercise training and alkaline supplementation']","['body weight and improve running performance', 'Body weight, body composition, running performance and acid-base parameters', 'Body weight', 'weight loss', 'body weight loss, body fat loss, visceral fat loss and running performance enhancement', 'running velocity', 'Body Weight Loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",80.0,0.0651852,"There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements.","[{'ForeName': 'Kuno', 'Initials': 'K', 'LastName': 'Hottenrott', 'Affiliation': 'Institute for Performance Diagnostics and Health Promotion, Martin-Luther-University of Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, Martin, 81106 Bratislava, Slovaki.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hottenrott', 'Affiliation': 'Faculty of Sport Science, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Till P', 'Initials': 'TP', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sport Science, Martin-Luther-University of Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Vormann', 'Affiliation': 'Institute for Prevention and Nutrition, 85737 Ismaning, Germany.'}]","Life (Basel, Switzerland)",['10.3390/life10050074']
2295,32455565,The Impact of an Early Lifestyle Intervention on Pregnancy Outcomes in a Cohort of Insulin-Resistant Overweight and Obese Women.,"Obese women are more likely to have decreased insulin sensitivity and are at increased risk for many adverse pregnancy outcomes. An early lifestyle intervention (LI) may have the potential to reduce the impact of insulin resistance (IR) on perinatal outcomes. We report post hoc analysis of an open-label randomized control trial that includes IR women with body-mass index ≥25 randomly assigned to a LI with a customized low glycemic index diet or to standard care (SC) involving generic counseling about healthy diet and physical activity. Women were evaluated at 16, 20, 28, and 36 weeks of gestation, at which times perinatal outcomes were collected and analyzed. An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks. More importantly, these women had a lower rate of large-for-gestational-age (LGA) infants ( p  = 0.04). Interestingly, the caloric restriction and low-glycemic index diet did not increase the rate of small-for-gestational-age (SGA) babies in the LI group. A lifestyle intervention started early in pregnancy on overweight and obese women had the potential to restore adequate glucose tolerance and mitigate the detrimental role of IR on neonatal outcomes, especially on fetal growth.",2020,"An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks.","['Obese women', 'Insulin-Resistant Overweight and Obese Women', 'IR women with body-mass index ≥25 randomly assigned to a', 'overweight and obese women']","['Early Lifestyle Intervention', 'early lifestyle intervention (LI', 'LI with a customized low glycemic index diet or to standard care (SC) involving generic counseling about healthy diet and physical activity', 'oral-glucose-tolerance test (OGTT']","['plasma glucose levels', 'Pregnancy Outcomes', 'rate of small-for-gestational-age (SGA) babies', 'insulin sensitivity', 'caloric restriction and low-glycemic index diet']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021296', 'cui_str': 'Small-for-dates baby'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0667227,"An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Menichini', 'Affiliation': 'International Doctorate School in Clinical and Experimental Medicine, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Petrella', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Dipace', 'Affiliation': 'Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, University Hospital Policlinic of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Di Monte', 'Affiliation': 'Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, University Hospital Policlinic of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Neri', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}]",Nutrients,['10.3390/nu12051496']
2296,32455620,Effects of Extra Virgin Olive Oil (EVOO) and the Traditional Brazilian Diet on Sarcopenia in Severe Obesity: A Randomized Clinical Trial.,"BACKGROUND


Nutritional interventions may have positive effects on sarcopenia and body composition.
OBJECTIVE


to evaluate the effectiveness of extra virgin olive oil (EVOO) consumption and a healthy traditional Brazilian diet (DieTBra) on improving sarcopenia indicators and reducing total body fat in severe obesity.
METHODS


A randomized controlled trial registered at ClinicalTrials.gov (NCT02463435) conducted with 111 severely obese participants randomized into three treatment groups-(1) EVOO (52 mL/day), (2) DieTBra, (3) DieTBra + EVOO (52 mL/day)-for 12 weeks. Body composition was assessed by dual-energy X-ray absorptiometry and sarcopenia by walking speed and handgrip strength.
RESULTS


Significant reductions in total body fat ( p  = 0.041) and body weight ( p  = 0.003) were observed in the DieTBra group. In the DietBra + olive oil group there was also a significant reduction in body weight (0.001) compared to the olive oil-only group. ANCOVA analyses showed reductions in total body fat in the DieTBra ( p  = 0.016) and DieTBra + olive oil ( p  = 0.004) groups. Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
CONCLUSIONS


DieTBra contributes to improvements in handgrip strength, walking speed, and total body fat in severely obese adults. The major study was registered at ClinicalTrials.gov (NCT02463435).",2020,"Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
","['Severe Obesity', 'severely obese adults', '111 severely obese participants randomized into three treatment groups-(1']","['extra virgin olive oil (EVOO) consumption and a healthy traditional Brazilian diet (DieTBra', 'DietBra + olive oil', 'Extra Virgin Olive Oil (EVOO', 'Traditional Brazilian Diet']","['handgrip strength, walking speed, and total body fat', 'Body composition', 'body weight', 'total body fat', 'handgrip strength', 'walking speed']","[{'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",111.0,0.118897,"Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Danésio de Souza', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Dos Santos Rodrigues', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Lima', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Darcy Ribeiro University Campus, Brasília CEP 70910-900, Distrito Federal, Brazil.'}, {'ForeName': 'Camila Kellen', 'Initials': 'CK', 'LastName': 'de Souza Cardoso', 'Affiliation': 'School of Social Sciences and Health, Nutrition Course, Pontifical Catholic University of Goias, Goiânia 74605-020, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, University College London, London WC1E 6BT, UK.'}]",Nutrients,['10.3390/nu12051498']
2297,32455817,"Actaea racemosa  L. Is More Effective in Combination with  Rhodiola rosea  L. for Relief of Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study.","Background : The aim of this study was to assess the efficacy and safety of a new herbal preparation (Menopause Relief EP ® ), the hybrid combination of  Actaea racemosa  L. (black cohosh, BC) and  Rhodiola rosea  L. (RR) root extracts, compared with the most effective dose of BC extract in women with menopausal complaints.  Methods:  A total of 220 women were randomly assigned to receive two capsules either BC (6.5 mg), BC500 (500 mg), Menopause Relief EP ®  (206,5), or placebo once per day for 12 weeks. The efficacy endpoints were relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index.  Results:  The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks. There was no statistically significant difference between the effects of BC and BC500 over time. RR-BC significantly improved the QOL index in patients, compared to BC, BC500, and placebo, mainly due to the beneficial effects on the emotional and health domains.  Conclusions:  BC is more effective in combination with RR in relief of menopausal symptoms, particularly psychological symptoms.",2020,The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks.,"['A total of 220 women', 'women with menopausal complaints', 'Menopausal Symptoms']","['Placebo', 'BC extract', 'new herbal preparation (Menopause Relief EP ® ', 'BC', 'BC500 (500 mg), Menopause Relief EP ®  (206,5), or placebo', 'placebo']","['efficacy and safety', 'relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index', 'QOL index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",220.0,0.473585,The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks.,"[{'ForeName': 'Lali', 'Initials': 'L', 'LastName': 'Pkhaladze', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Davidova', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Archil', 'Initials': 'A', 'LastName': 'Khomasuridze', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Ramaz', 'Initials': 'R', 'LastName': 'Shengelia', 'Affiliation': 'Department for History of Medicine and Bioethics, Tbilisi State Medical University, Vazha-Pshavela avenue 33, Tbilisi 0162, Georgia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Panossian', 'Affiliation': 'Phytomed AB, Bofinkvagen 1, 31275 Vaxtorp, Sweden.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13050102']
2298,32442195,Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.,"BACKGROUND


DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle.
METHODS AND FINDINGS


The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects.
CONCLUSIONS


In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.",2020,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","['Per-protocol cohorts included vaccine recipients from HVTN 100', 'southern Africa with harmonized trial designs', 'n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017']","['placebo', 'ALVAC priming', 'DNA plasmid versus canarypox virus (ALVAC']","['IgG bAb response rates', 'nAb response rates', 'Response rates to V1V2', 'binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96', 'bAb net mean fluorescence intensity (MFI', 'CD4+ T-cell response rates']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0211671', 'cui_str': 'ALVAC vaccine'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0282472', 'cui_str': 'Canarypox virus'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0019686', 'cui_str': 'AIDS Antigens'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.585483,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Maganga', 'Affiliation': 'NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Herce', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Heptinstall', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensberg, Regensberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003117']
2299,32442198,No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.,"BACKGROUND


Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya.
METHODS


We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately.
RESULTS


All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes.
CONCLUSION


No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa.
TRIAL REGISTRATION


ClinicalTrials.gov registration # NCT02390310.",2020,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","['boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya', 'young adolescent boys, specifically ages 10-12 years', '10-12 year old boys', '197 boys aged 10 to 12 years', 'in men and boys']","['topical vs. injectable anesthesia with ShangRing circumcision', 'no-flip ShangRing circumcision technique', 'Topical anesthesia']","['Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction', 'Median dwell time of the topical anesthetic', 'positive safety profile', 'mean pain score', 'Mean time required for spontaneous ShangRing detachment']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}]",197.0,0.304241,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Al Hussein Alawamlh', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Quentin D', 'Initials': 'QD', 'LastName': 'Awori', 'Affiliation': 'EngenderHealth, Nairobi, Kenya.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Barone', 'Affiliation': 'EngenderHealth, Washington, DC, NY, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Li', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0233150']
2300,32442205,No effect of repetitive tDCS on daily smoking behaviour in light smokers: A placebo controlled EMA study.,"INTRODUCTION


The effectiveness of repetitive transcranial Direct Current Stimulation (tDCS) on reducing smoking behaviour has been studied with mixed results. Smoking behaviour is influenced by affect and context, therefore we choose to use mobile ecological momentary assessments (EMA) to measure changes in smoking behaviour after tDCS.
METHODS


In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right DLPFC (https://clinicaltrials.gov/ct2/show/NCT03027687). Smokers were allocated to six sessions of either active tDCS (n = 35) or sham tDCS (n = 36) and received two sessions on three different days in one week. They were asked to keep track of their daily cigarette consumption, craving and affect in an application on their mobile phones for three months starting one week before the first tDCS session.
RESULTS


Number of smoked cigarettes a day progressively decreased up to one week after the last tDCS session in both conditions. Active treatment had no additional effect on cigarette consumption, craving and affect.
CONCLUSIONS


In this exploratory study, repetitive bilateral tDCS over the DLPFC had no effect on daily smoking behaviour. Future research needs to investigate how motivation to quit smoking and the number of tDCS sessions affect the efficacy of repetitive tDCS.",2020,"Active treatment had no additional effect on cigarette consumption, craving and affect.
",['light smokers'],"['repetitive transcranial Direct Current Stimulation (tDCS', 'sham tDCS', 'active tDCS', 'repetitive tDCS', 'placebo']","['daily smoking behaviour', 'cigarette consumption, craving and affect']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0277547,"Active treatment had no additional effect on cigarette consumption, craving and affect.
","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Jongerling', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233414']
2301,32442298,"Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients: a randomized, double-blinded multicenter phase 2 trial.","Hospitalized patients with cancer are at an increased risk of developing venous thromboembolism (VTE). The recommendation for routine pharmacologic thromboprophylaxis in hospitalized patients with cancer to prevent VTE is based on extrapolation of results from noncancer cohorts. There are limited data to support the efficacy and safety of fixed-dose low-molecular-weight heparin (LMWH) regimens in high-risk hospitalized patients with cancer. We conducted a randomized, double-blinded, phase 2 trial in hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score. Patients were randomly assigned to fixed-dose enoxaparin (40 mg daily) vs weight-adjusted enoxaparin (1 mg/kg daily) during hospitalization. The primary objectives were to evaluate the safety of dose-adjusted enoxaparin and evaluate the incidence of VTE with fixed-dose enoxaparin. Blinded clinical assessments were performed at day 14, and patients randomly assigned to fixed-dose enoxaparin subsequently underwent a bilateral lower extremity ultrasound. A total of 50 patients were enrolled and randomized. The median weight of patients enrolled in weight-adjusted enoxaparin arm was 76 kg (range, 60.9-124.5 kg). There were no major hemorrhages or symptomatic VTE in either arm. At time of completion of the blinded clinical assessment, there was only 1 incidentally identified pulmonary embolus that occurred in the weight-adjusted arm. In the group randomly assigned to fixed-dose enoxaparin who subsequently underwent surveillance ultrasound, the cumulative incidence of DVT was 22% (90% binomial confidence interval, 0%-51.3%). This phase 2 trial confirms a high incidence of asymptomatic VTE among high-risk hospitalized patients with cancer and that weight-adjusted LMWH thromboprophylaxis is feasible and well-tolerated. This trial was registered at www.clinicaltrials.gov as #NCT02706249.",2020,There were no major hemorrhages or symptomatic VTE in either arm.,"['high-risk hospitalized patients with cancer and that weight-adjusted', 'Hospitalized patients with cancer', 'hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score', 'hospitalized cancer patients', 'A total of 50 patients were enrolled and randomized', 'hospitalized patients with cancer', 'high-risk hospitalized patients with cancer']","['LMWH thromboprophylaxis', 'enoxaparin thromboprophylaxis', 'enoxaparin', 'weight-adjusted enoxaparin', 'heparin (LMWH) regimens']","['cumulative incidence of DVT', 'major hemorrhages or symptomatic VTE', 'median weight', 'risk of developing venous thromboembolism (VTE']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",50.0,0.551685,There were no major hemorrhages or symptomatic VTE in either arm.,"[{'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Zwicker', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Roopkumar', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Schlechter', 'Affiliation': 'Gastrointestinal Cancer Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; and.'}, {'ForeName': 'Anish V', 'Initials': 'AV', 'LastName': 'Sharda', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peereboom', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Joyce', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bockorny', 'Affiliation': 'Division of Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Neuberg', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}]",Blood advances,['10.1182/bloodadvances.2020001804']
2302,32443977,"The evaluation of Suchana, a large-scale development program to prevent chronic undernutrition in north-eastern Bangladesh.","Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated.",2020,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","['chronic undernutrition in north-eastern Bangladesh', '157 unions, the smallest administrative unit of government, in two districts of Sylhet']",['community-based nutrition programs'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0221132,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","[{'ForeName': 'Nuzhat', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. nuzhat@icddrb.org.'}, {'ForeName': 'Mohammad Jyoti', 'Initials': 'MJ', 'LastName': 'Raihan', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'S M Tanvir', 'Initials': 'SMT', 'LastName': 'Ahmed', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Kazi Eliza', 'Initials': 'KE', 'LastName': 'Islam', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Self', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Shahed', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}]",BMC public health,['10.1186/s12889-020-08769-4']
2303,32443981,"Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).","BACKGROUND


Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
METHODS


This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI.
DISCUSSION


The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages.
TRIAL REGISTRATION


The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",2020,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","['people with progressive MS (PMS', 'people with progressive multiple sclerosis', 'Three hundred and sixty subjects from 11 sites', 'people with PMS who have cognitive impairment', '6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages', 'people with relapsing-remitting MS without cognitive impairment', 'people with progressive forms of the disease who have objectively identified cognitive impairment']","['cognitive rehabilitation and aerobic exercise (COGEx', 'cognitive rehabilitation (CR) and aerobic exercise (EX', 'CR and aerobic exercise', 'CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise']","[' indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI', 'Symbol Digit Modalities Test (SDMT) measuring PS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",,0.510419,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square MS Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, DK-8000, Aarhus, Denmark. dalgas@ph.au.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth, Devon, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01772-7']
2304,32444033,The effect of lavender herbal tea on the anxiety and depression of the elderly: A randomized clinical trial.,"BACKGROUND


The prevalence of depression and anxiety is increasing among the elderly around the world. It is believed that lavender can stabilize the people's mood, so this study was designed to evaluate the effect of lavender on anxiety and depression of the elderly.
METHODS


This study was a single blind clinical trial with a control group. The participants in the study consisted of 60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019. The intervention consisted of using 2 g of lavender teabag, which was prescribed to be used 2 times as decoction in the morning and night. The duration of the intervention was 2 weeks. The eligible participants were randomly assigned to the intervention and control groups using balanced block randomization with a block size of ten. The control group did not receive any placebo. Data collection tools in this study included demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory. Chi-square test and independent t-test were used to analyze the data. The significance level was considered 5 %.
RESULTS


The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference. The mean score of depression in the intervention group before and after drinking lavender herbal tea was 17.80 ± 1.49 and 16.33 ± 1.49, respectively. The mean score of depression between intervention and control groups after drinking herbal tea were 16.33 ± 1.49 and 18.33 ± 1.84, respectively. This indicated the effect of herbal tea on reducing depression (P < 0.001). Also, mean difference of intervention and control groups after drinking herbal tea in terms of depression and anxiety (state and trait) were (-2.00, 95 % CI (-2.86, -1.13)), (-6.40, 95 % CI (-9.43, -3.36)) and (-4.13, 95 % CI (-7.66, -0.60)), respectively.
CONCLUSION


The results of the present study showed that consumption of lavender herbal tea can reduce depression and anxiety scores and since it is inexpensive and accessible, it is suggested to be used as a complementary treatment in reducing anxiety and depression.",2020,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","['anxiety and depression of the elderly', '60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019']","['placebo', 'herbal tea', 'lavender herbal tea', 'lavender']","['reducing depression', 'mean score of depression', 'demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory', 'depression and anxiety scores', 'depression and anxiety (state and trait']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019233', 'cui_str': 'Herbal tea'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1301808', 'cui_str': 'State'}]",60.0,0.0480723,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","[{'ForeName': 'Mohammad-Rafi', 'Initials': 'MR', 'LastName': 'Bazrafshan', 'Affiliation': 'Department of Nursing, School of Nursing, Larestan University of Medical Sciences, Larestan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Jokar', 'Affiliation': 'Department of Nursing, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Shokrpour', 'Affiliation': 'English Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Delam', 'Affiliation': 'Student Research Committee, Larestan University of Medical Sciences, Larestan, Iran. Electronic address: hameddelam8@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102393']
2305,32444619,Virtual reality clinical-experimental tests of compassion treatment techniques to reduce paranoia.,"Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = <0.0001, d = 1.4) and decreased in paranoia (group difference = -1.73, C.I. = -2.48; -0.98, p = <0.0001, d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.",2020,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","['Two-hundred individuals from the general population scoring highly for paranoia were recruited', 'Individuals repeatedly entered neutral virtual reality social environments']",['LKM'],"['paranoia', 'Change in compassion', 'self-compassion', 'compassion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",200.0,0.084631,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","[{'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. poppy.brown@psych.ox.ac.uk.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Scientific reports,['10.1038/s41598-020-64957-7']
2306,32444629,Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial.,"Minimally invasive surgery for inguinal hernia repair is advantageous in terms of return to usual activities and lower rates of chronic pain; however, it requires general anesthesia. This study sought to analyze the benefits of ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block) as a single anesthetic technique for endoscopic totally extraperitoneal (TEP) inguinal hernia repair with regard to postoperative pain, length of hospital stay, and hospital cost. A total of 46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair. In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia. Consequently, the former group showed a briefer median hospital stay (6 versus 24 hours, respectively). The anesthesia and hospital costs were also lower for the QL block group, with median reductions of 64.15% and 25%, respectively. QL block is a safe and effective option for patients undergoing TEP inguinal hernia repair, given the observed reduction in early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs.",2020,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"['46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received', 'Tep) Inguinal Hernia Repair', 'patients undergoing TEP inguinal hernia repair']","['ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block', 'general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair', 'Laparoscopic Totally Extraperitoneal', 'Minimally invasive surgery', 'QL block', 'endoscopic totally extraperitoneal (TEP) inguinal hernia repair']","['median pain score', 'Quadratus Lumborum Block', 'anesthesia and hospital costs', 'briefer median hospital stay', 'postoperative pain, length of hospital stay, and hospital cost', 'early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",46.0,0.130019,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"[{'ForeName': 'Murillo de Lima', 'Initials': 'ML', 'LastName': 'Favaro', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil. mlfavaro@prof.unisa.br.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Gabor', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Diogo Barros Florenzano', 'Initials': 'DBF', 'LastName': 'Souza', 'Affiliation': 'Professor of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Anderson Alcoforado', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Ana Luiza Castro', 'Initials': 'ALC', 'LastName': 'Milani', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Augusto Fontenelle', 'Initials': 'MAF', 'LastName': 'Ribeiro Junior', 'Affiliation': 'Full Professor of General Surgery at the University Santo Amaro, São Paulo, Brazil.'}]",Scientific reports,['10.1038/s41598-020-65604-x']
2307,32444670,A new approach to prevent cervical stenosis in postmenopausal women after loop electrosurgical excision procedure: a randomized controlled trial.,"To determine whether regular cervical dilatation is effective for preventing cervical stenosis, and to identify the associated risk factors, in postmenopausal women after LEEP. This was a prospective randomized clinical trial in postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019. Patients who met the study criteria were randomly allocated to three groups: control group (without any intervention), intervention group A (underwent cervical dilatation at the 3 rd , 5 th , and 8 th  week after LEEP) and intervention group B (underwent cervical dilatation at the 4 th , 8 th , and 12 th  week after LEEP). A colposcopic follow-up examination was conducted at 6 months after LEEP to determine the incidence of cervical stenosis. A total of 404 postmenopausal women were found to be finally eligible for the study. The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group B. We found regular dilatation after LEEP in postmenopausal women can prevent cervical stenosis. Further, the 3rd, 5th, and 8th weeks after LEEP are optimal time points. Finally, LEEP frequency and resection depth are significant risk factors and can be used to screen postmenopausal women at risk for cervical stenosis after LEEP.",2020,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","['screen postmenopausal women at risk for cervical stenosis after LEEP', 'Patients who met the study criteria', 'postmenopausal women after loop electrosurgical excision procedure', 'postmenopausal women', '404 postmenopausal women were found to be finally eligible for the study', 'postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019', 'postmenopausal women after LEEP']","['regular cervical dilatation', 'control group (without any intervention), intervention group A (underwent cervical dilatation']",['rate of cervical stenosis'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}]",404.0,0.0439457,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhunan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. dr.wudan@163.com.'}]",Scientific reports,['10.1038/s41598-020-65170-2']
2308,32446164,Determination of levels of oxidative stress and nitrosative stress in patients with epilepsy.,"BACKGROUND


Epilepsy is one of the most common neurological diseases. The underlying pathophysiological mechanisms in epilepsy are still unknown. Oxidative stress is believed to be one of the factors involved in the pathogenesis of epileptogenesis. In various pathophysiological conditions, reactive nitrogen species (RNS) such as nitrogen and peroxynitrite are produced and these RNSs can bind to free nucleosides and nucleotides or to nucleosides and nucleotides existing in the DNA/RNA structure. 8-Nitroguanine (8-NG) is a typical DNA nucleobase product of nitrosative damage generated by RNS. It has been proposed that F2-isoprostanes, in particular 8-iso-Prostaglandin F2α (8-isoPGF2α), are specific, reliable and non-invasive biomarkers of lipid peroxidation in vivo. In the present study, we compared the levels of lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG in patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants.
METHODS


The present study comprised 90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy. The patients were assigned into the intervention (n = 45) and control (n = 45) groups. Of the participants in the intervention group, 37.7% (n = 17) were treated with levetiracetam (LEV), 33.3% (n = 15) with valproic acid (VA) and 29% (n = 13) with carbamazepine. Serum 8-iso-PGF2α and 8-NG levels of the participants in the intervention and control groups were determined by ELISA.
RESULTS


There was no significant difference between the medication (LEV, VA, Carbamazepine) used by the participants and their 8-iso-PGF2α and 8-NG levels (p > 0.05). However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
CONCLUSION


Our study demonstrated that there was an increase in oxidative and nitrosative stres markers in patients with epilepsy. There was no significant difference between the 8-iso-PGF2α and 8-NG levels of the participants taking three different AEDs.",2020,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","['patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants', 'patients with epilepsy', '90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy']","['levetiracetam (LEV', 'valproic acid (VA', 'lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG', 'carbamazepine', '8-Nitroguanine']","['Serum 8-iso-PGF2α and 8-NG levels', 'oxidative stress and nitrosative stress', 'medication (LEV, VA, Carbamazepine', '8-iso-PGF2α and 8-NG', '8-iso-PGF2α and 8-NG levels', 'oxidative and nitrosative stres markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.0414708,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","[{'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ersan', 'Affiliation': 'Nigde Ömer Halisdemir University, Medical Faculty, Department of Biochemistry, Niğde, Turkey. Electronic address: serpilersan@gmail.com.'}, {'ForeName': 'Burhanettin', 'Initials': 'B', 'LastName': 'Cigdem', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Neurology, Sivas, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bakir', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}, {'ForeName': 'H Okan', 'Initials': 'HO', 'LastName': 'Dogan', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106352']
2309,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND


With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake.
METHODS


We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control.
RESULTS


There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (p <  0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups.
CONCLUSION


This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098']
2310,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES


More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach.
METHODS


The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied.
RESULTS


According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found.
CONCLUSIONS


Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095']
2311,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION


Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS


This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS


A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION


As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
2312,32455860,Impact of Meal Timing and Chronotype on Food Reward and Appetite Control in Young Adults.,"Early meal timing and chronotype are associated with lower BMI, but their impact on appetite is poorly understood. We examined the impact of meal timing and chronotype on appetite and food reward. Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ). Participants attended the laboratory after ≥3 h fast on two occasions for early (AM; 8-10 a.m.) and late (PM; 4-6 p.m.) counterbalanced testing sessions in a 2 × 2 design. Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire) were measured in response to a standardized test meal. LC was associated with higher BMI ( p  = 0.01), but not with EI or TFEQ. The composite appetite score was lower in AM than PM (M Δ = -5 (95% CI -10, -0.2) mm,  p  = 0.040). Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038). Liking and wanting high-fat food were lower in AM than PM ( p  ≤ 0.004). The late chronotype was associated with greater desire for high-fat food ( p  = 0.006). To conclude, early meal timing and early chronotype are independently associated with smaller appetite and lower desire for high-fat food.",2020,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"['Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or', 'Young Adults']","['late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ', 'Meal Timing and Chronotype']","['Perceived test meal fillingness', 'Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire', 'composite appetite score', 'higher BMI', 'Liking and wanting high-fat food']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}]",44.0,0.024407,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Shaea', 'Initials': 'S', 'LastName': 'Alkahtani', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alhussain', 'Affiliation': 'Department of Food Science and Nutrition, College of Food and Agricultural Sciences, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Salling Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}]",Nutrients,['10.3390/nu12051506']
2313,32455866,Phytosterols Supplementation Reduces Endothelin-1 Plasma Concentration in Moderately Hypercholesterolemic Individuals Independently of Their Cholesterol-Lowering Properties.,"Experimental and clinical studies have demonstrated the effect of phytosterols (PS) on reducing plasma levels of cholesterol and LDL-c, but the effects of plant sterols beyond cholesterol-lowering are still questionable. Since inflammation and endothelial dysfunction are involved in the pathogenesis of atherosclerosis, this study aims to evaluate the effect of PS on biomarkers involved in atherosclerosis progression and whether these effects are independent of alterations in plasma LDL-c levels. Thirty-eight moderately hypercholesterolemic volunteers (58 ± 12 years; LDL-c ≥ 130 mg/dL) were randomly assigned to consume 400 mL/day of soy milk or soy milk + PS (1.6 g/day) for 4 weeks in a double-blind, placebo-controlled, cross-over study. Blood samples were collected and lipid profiles and biomarkers for inflammation and endothelial dysfunction determined. The results showed that PS treatment reduced endothelin-1 plasma concentration by 11% ( p  = 0.02) independently of variations in plasma levels of LDL-c. No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups. Furthermore, PS reduced total plasma cholesterol concentration (-5,5%,  p  < 0.001), LDL-c (-6.4%,  p  < 0.05), triglycerides (-8.3%,  p  < 0.05), and apo B (-5.3%,  p  < 0.05), without changing HDL-c concentration ( p  > 0.05). Therefore, PS supplementation effectively lowers endothelin-1 independently of the reductions in plasma levels of LDL-c, contributing to the comprehension of the effect of plant sterols on endothelial function and prevention of cardiovascular diseases.",2020,"No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups.","['Thirty-eight moderately hypercholesterolemic volunteers (58 ± 12 years', 'Moderately Hypercholesterolemic Individuals']","['Phytosterols Supplementation', 'consume 400 mL/day of soy milk or soy milk + PS', 'phytosterols (PS', 'placebo']","['triglycerides', 'total plasma cholesterol concentration', 'endothelial function and prevention of cardiovascular diseases', 'Endothelin-1 Plasma Concentration', 'fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1', 'endothelin-1 plasma concentration', 'LDL-c', 'LDL-c ≥']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0452741', 'cui_str': 'Soya milk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",38.0,0.151145,"No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oliveira Godoy Ilha', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Sutti Nunes', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Milessa', 'Initials': 'M', 'LastName': 'Silva Afonso', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Regina Nakandakare', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'da Silva Ferreira', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'de Paula Assis Bombo', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rodrigues Giorgi', 'Affiliation': 'Laboratory of Cellular and Molecular Endocrinology (LIM-25), Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Marcondes Machado', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Eder', 'Initials': 'E', 'LastName': 'Carlos Rocha Quintão', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Lottenberg', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}]",Nutrients,['10.3390/nu12051507']
2314,32455947,Changes in Bone Marrow Fat upon Dietary-Induced Weight Loss.,"BACKGROUND


Bone marrow fat is implicated in metabolism, bone health and haematological diseases. Thus, this study aims to analyse the impact of moderate weight loss on bone marrow fat content (BMFC) in obese, healthy individuals.
METHODS


Data of the HELENA-Trial (Healthy nutrition and energy restriction as cancer prevention strategies: a randomized controlled intervention trial), a randomized controlled trial (RCT) among 137 non-smoking, overweight or obese participants, were analysed to quantify the Magnetic Resonance Imaging (MRI)-derived BMFC at baseline, after a 12-week dietary intervention phase, and after a 50-week follow-up. The study cohort was classified into quartiles based on changes in body weight between baseline and week 12. Changes in BMFC in respect of weight loss were analysed by linear mixed models. Spearman's coefficients were used to assess correlations between anthropometric parameters, blood biochemical markers, blood cells and BMFC.
RESULTS


Relative changes in BMFC from baseline to week 12 were 0.0 ± 0.2%, -3.2 ± 0.1%, -6.1 ± 0.2% and -11.5 ± 0.6% for Q1 to Q4. Across all four quartiles and for the two-group comparison, Q1 versus Q4, there was a significant difference ( p  < 0.05) for changes in BMFC. BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
CONCLUSION


Weight loss is associated with a decrease of BMFC. However, BMFC showed no stronger associations with inflammatory and metabolic biomarkers.",2020,"BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
","['obese, healthy individuals', '137 non-smoking, overweight or obese participants']",['BMFC'],"['blood cell counts', 'BMFC', 'body weight', 'bone marrow fat content (BMFC', 'weight loss', 'Magnetic Resonance Imaging (MRI)-derived BMFC', 'anthropometric parameters, blood biochemical markers, blood cells and BMFC']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}]",137.0,0.0619532,"BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Spurny', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Solomon A', 'Initials': 'SA', 'LastName': 'Sowah', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Schübel', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nonnenmacher', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bertheau', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Kirsten', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Theron', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, New York 14263, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Schlett', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, D-79106 Freiburg, Germany.'}, {'ForeName': 'Oyunbileg', 'Initials': 'O', 'LastName': 'von Stackelberg', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Huntsman Cancer Institute and Department of Population Health Sciences, University of Utah, 2000 Circle of Hope, Salt Lake City, UT 84112-5550, USA.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nattenmüller', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}]",Nutrients,['10.3390/nu12051509']
2315,32456048,Effect of Plyometric versus Ankle Stability Exercises on Lower Limb Biomechanics in Taekwondo Demonstration Athletes with Functional Ankle Instability.,"BACKGROUND


This study aimed to compare the effects of plyometric and ankle stability exercises on the dynamic balance and lower limb kinematic and kinetic parameters of Taekwondo demonstration athletes with functional ankle instability.
METHODS


Fourteen subjects participated in this study and were randomly divided into two groups: a plyometric exercise group ( n  = 7) and an ankle stability exercise group ( n  = 7). Exercises were performed twice a week for 8 weeks. A Y-balance test was used to measure dynamic balance, and a motion analysis system and force plate were used to collect kinematic and kinetic parameters during single-leg drop landing. A paired t-test was used for intragroup comparisons, and an independent t-test was used for intergroup comparisons.
RESULTS


In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05). The plyometric exercise group decreased their ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion ( p  < 0.05). In contrast, the stability exercise increased their ankle plantar flexion at initial contact ( p  < 0.05).
CONCLUSIONS


The plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing. This study suggests that the application of plyometric exercises in ankle rehabilitation would improve stability and shock absorption and help prevent injuries during Taekwondo demonstrations.",2020,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05).","['Taekwondo Demonstration Athletes with Functional Ankle Instability', 'Fourteen subjects participated in this study', 'Taekwondo demonstration athletes with functional ankle instability']","['plyometric and ankle stability exercises', 'Plyometric versus Ankle Stability Exercises', 'plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing', 'plyometric exercise group ( n  = 7) and an ankle stability exercise group', 'plyometric exercises', 'plyometric exercise']","['stability exercise increased their ankle plantar flexion', 'ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion', 'dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement', 'stability and shock absorption']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0576206', 'cui_str': 'Stability of ankle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",14.0,0.0237313,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05).","[{'ForeName': 'Ha Min', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103665']
2316,32456442,"Herbal Drug EPs 7630  versus  Amoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study.","OBJECTIVE


Previous investigations suggest the use of extract from the root of  Pelargonium sidoides  (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS).
METHODS


Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy.
RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups ( P  = .248;  P  = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group.
CONCLUSION


Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.",2020,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","['Fifty ABRS patients', 'Patients with Uncomplicated Acute Bacterial Rhinosinusitis', 'patients with mild to moderate acute bacterial rhinosinusitis (ABRS']","['amoxicillin', 'EPs 7630 and amoxicillin monotherapy', 'amoxicillin tablets', 'Herbal Drug EPs 7630  versus  Amoxicillin']","['rhinorrhea score and postnasal drip score', 'clinical efficacy, safety and bactericidal effect', 'TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion', 'adverse events', 'total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1244600', 'cui_str': 'Amoxicillin Oral Tablet'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0443266', 'cui_str': 'Mucopurulent'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",50.0,0.0241304,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Perić', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Gaćeša', 'Affiliation': 'ENT Hospital ""Dr. Žutić"", Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Barać', 'Affiliation': 'School of Medicine, University in Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Sotirović', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Aneta V', 'Initials': 'AV', 'LastName': 'Perić', 'Affiliation': 'Institute for Pharmacy, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420918266']
2317,32456468,Examining mediators of intervention efficacy in a randomised controlled m-health trial to improve physical activity and sleep health in adults.,"Objectives:  Examining mediators of intervention efficacy in an m-health intervention targeting physical activity and sleep in 160 Australian adults. Design:  Nationwide randomised controlled trial. Main outcome measures:  Moderate- and vigorous-intensity physical activity (MVPA), assessed using the Active Australia Questionnaire; sleep quality (Pittsburgh Sleep Quality Index); and sleep hygiene practices (Sleep Hygiene Index). Hypothesised psychosocial (e.g. self-efficacy) and behavioural (i.e. MVPA, sleep quality, sleep hygiene) mediators were tested on primary endpoint data at 3 months using bias-corrected bootstrapping (PROCESS 2 for SPSS). All outcomes and mediators were assessed using self-report. Results:  At three months, the intervention had significantly improved sleep quality ( d  = 0.48, 95% CI: -2.26, -0.33,  p  = 0.009) and sleep hygiene ( d  = 0.40, 95% CI: -3.10, -0.19,  p  = 0.027). Differences in MVPA were not significant ( d  = 0.24, 95% CI: -35.53, 254.67,  p  = 0.139). Changes in MVPA were mediated by self-efficacy, perceived capability, environment, social support, intentions and planning, some of which showed inconsistent mediation (suppression). None of the hypothesised psychosocial factors mediated sleep outcomes. Changes in sleep hygiene mediated changes in sleep quality. Conclusions:  Several psychosocial factors mediated changes in physical activity but not in sleep outcomes. Mediation effects of sleep hygiene on sleep quality highlight the importance of providing evidence-based strategies to improve sleep quality.",2020,"Changes in MVPA were mediated by self-efficacy, perceived capability, environment, social support, intentions and planning, some of which showed inconsistent mediation (suppression).","['adults', '160 Australian adults']","['m-health intervention', 'sleep hygiene']","['Hypothesised psychosocial (e.g. self-efficacy) and behavioural (i.e. MVPA, sleep quality, sleep hygiene) mediators', 'physical activity', 'MVPA', 'sleep hygiene', 'physical activity and sleep health', 'Moderate- and vigorous-intensity physical activity (MVPA), assessed using the Active Australia Questionnaire; sleep quality (Pittsburgh Sleep Quality Index); and sleep hygiene practices (Sleep Hygiene Index', 'sleep quality', 'self-efficacy, perceived capability, environment, social support, intentions and planning']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",160.0,0.0912101,"Changes in MVPA were mediated by self-efficacy, perceived capability, environment, social support, intentions and planning, some of which showed inconsistent mediation (suppression).","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Appleton Institute, Physical Activity Research Group, Central Queensland University, Rockhampton, QLD, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, NSW, Australia.'}]",Psychology & health,['10.1080/08870446.2020.1756288']
2318,32456475,"Detecting feigned symptoms of depression, anxiety, and ADHD, in college students with the structured inventory of malingered symptomatology.","Objective:  Research consistently shows how easily students can feign symptoms of ADHD on self-report checklists to determine eligibility for curricular and standardized testing accommodations. However, it is unclear how easily students can feign psychological symptoms to accesses academic accommodations, making the assessment of symptom validity important in both populations. Method:  Using a between-subjects design, 75 college students were randomly assigned to one of three groups: (1) coached feigning of ADHD, (2) coached feigning of depression and anxiety (DA), and (3) honest responding (HR). Participants completed the Depression, Anxiety, and Stress Scale (DASS-21) and the Structured Inventory of Malingered Symptomatology (SIMS). Results:  The SIMS showed 100% specificity, but low sensitivity (36-52%) for detecting feigned symptoms with different cutoffs. Differences on SIMS subtests were apparent by group with elevated scores for the DA group on the Affective Disorders subscale and elevation for the ADHD group on the Low Intelligence and Amnestic subscales. Participants identified as feigning by the SIMS typically reported more severe symptoms than participants not identified on the DASS-21. Conclusions:  The SIMS equally classified the feigned ADHD and DA participants for both cutoff scores utilized. Potential reasons for low sensitivity rates are discussed and future research recommendations are made.",2020,Differences on SIMS subtests were apparent by group with elevated scores for the DA group on the Affective Disorders subscale and elevation for the ADHD group on the Low Intelligence and Amnestic subscales.,"['college students with the structured inventory of malingered symptomatology', '75 college students']","['coached feigning of ADHD, (2) coached feigning of depression and anxiety (DA), and (3) honest responding (HR']","['severe symptoms', 'Low Intelligence and Amnestic subscales', 'low sensitivity', 'Depression, Anxiety, and Stress Scale (DASS-21) and the Structured Inventory of Malingered Symptomatology (SIMS', 'SIMS subtests']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0423903', 'cui_str': 'Low intelligence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0233468,Differences on SIMS subtests were apparent by group with elevated scores for the DA group on the Affective Disorders subscale and elevation for the ADHD group on the Low Intelligence and Amnestic subscales.,"[{'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Grant', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lace', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Carson L', 'Initials': 'CL', 'LastName': 'Teague', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Lowell', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Ruppert', 'Affiliation': 'Department of Psychiatry, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Garner', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Gfeller', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2020.1769097']
2319,32456618,"Effectiveness of mobile SMS based counselling intervention in improving the knowledge, attitude, and practices of HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia: a mixed mode study protocol.","BACKGROUND


HIV/AIDS is one of the most serious problems in many parts of the world, and is a high priority for health managers and decision-makers. The aim of the qualitative part of this study will be to develop a mobile SMS (short messaging services) counselling intervention to prevent HIV/AIDS, while the quantitative part will be to test the effectiveness of a mobile SMS counselling intervention to improve the knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS.
METHOD


A mixed methods approach will be used. Qualitative part: Design: focus group discussions (FGDs) will be conducted.
SETTING


Hospital/NGOs in Terengganu, Malaysia.
PARTICIPANTS


Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders. One FGD will be conducted for each group. Three in-depth interviews (IDIs) will be conducted with patients who had HIV/AIDS, of which one will be female. Quantitative part: Design: a cluster randomized clinical trial with 384 HIV/AIDS patients in Terengganu, Malaysia.
INTERVENTION


Mobile SMS counselling intervention for patients concerning the prevention of HIV/AIDS.
RESULTS


The main outcomes of this study will be the differences in knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS between the baseline and immediate follow-up after the intervention, and after 3 months.
CONCLUSIONS


The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
TRIAL REGISTRATION


Thai Clinical Trials Registry, TCTR20200212001; 7/02/2020.",2020,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","['Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders', '384 HIV/AIDS patients in Terengganu, Malaysia', 'Hospital/NGOs in Terengganu, Malaysia', 'HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia', 'patients who had HIV/AIDS, of which one will be female']","['mobile based SMS counselling intervention', 'mobile SMS based counselling intervention', 'Mobile SMS counselling intervention', 'mobile SMS counselling intervention']","['knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",384.0,0.220058,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia. md.hossain@umt.edu.my.'}, {'ForeName': 'Ruhani Binti Mat', 'Initials': 'RBM', 'LastName': 'Min', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Zikri', 'Initials': 'Z', 'LastName': 'Muhammad', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan K C', 'Initials': 'KKC', 'LastName': 'Mani', 'Affiliation': 'Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",BMC public health,['10.1186/s12889-020-08910-3']
2320,32456702,The effect of information on prostate cancer screening decision process: a discrete choice experiment.,"BACKGROUND


Prostate cancer screening is controversial because of uncertainty about its benefits and risks. The aim of this survey was to reveal preferences of men concerning prostate cancer screening and to test the effect of an informative video on these preferences.
METHODS


A stated preferences questionnaire was sent by e-mail to men aged 50-75 with no history of prostate cancer. Half of them were randomly assigned to view an informative video. A discrete choice model was established to reveal men's preferences for six prostate cancer screening characteristics: mortality by prostate cancer, number of false positive and false negative results, number of overdiagnosis, out-of-pocket costs and recommended frequency.
RESULTS


A population-based sample composed by 1024 men filled in the entire questionnaire. Each attribute gave the expected sign except for overdiagnosis. The video seemed to increase the intention to abstain from prostate cancer screening.
CONCLUSIONS


The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis. Further research is needed to help men make an informed choice regarding screening.",2020,The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis.,"['A population-based sample composed by 1024 men filled in the entire questionnaire', 'A stated preferences questionnaire was sent by e-mail to men aged 50-75 with no history of prostate cancer']",[],"['prostate cancer mortality', 'number of false negatives']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",6.0,0.0371722,The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Charvin', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France. maud_charvin@yahoo.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Launoy', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berchi', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France.'}]",BMC health services research,['10.1186/s12913-020-05327-x']
2321,32456704,Use of web-based game in neonatal resuscitation - is it effective?,"BACKGROUND


Knowledge and skills decline within months post simulation-based training in neonatal resuscitation. To empower 'Millennial' learners to take control of their own learning, a single-player, unguided web-based Neonatal Resuscitation Game was designed. The present study investigates the effectiveness of the game on retention of resuscitation knowledge and skills.
METHODS


The study evaluated 162 healthcare professionals who attended simulation-based training in neonatal resuscitation. Following standard simulation-based training, participants were assigned to either a gaming group (Gamers) with access to the web-based Neonatal Resuscitation Game or a control group (Controls) with no access to the game. Although Gamers were given access, game utilization was completely voluntary and at will. Some Gamers chose to utilize the web-based game (Players) and others did not (Non-players). Knowledge and skills in neonatal resuscitation were assessed upon completion of training and 6 months post-training using a multiple-choice question test and a manikin-based skills test. Changes in scores were compared statistically between Gamers vs Controls, Players vs Controls, and Players vs Controls + Non-players using two-sample t-tests.
RESULTS


At the final assessment, declines in knowledge scores were seen in all groups. Mean change from baseline in knowledge and skill performance scores at 6 months, adjusted for baseline skill performance and MCQ test scores, did not differ significantly between Players vs Controls and Players vs Controls + Non-players.
CONCLUSION


The web-based game in its current format may not be effective in facilitating retention of knowledge and technical skills in neonatal resuscitation.",2020,"At the final assessment, declines in knowledge scores were seen in all groups.","['162 healthcare professionals who attended simulation-based training in neonatal resuscitation', 'neonatal resuscitation']",['gaming group (Gamers) with access to the web-based Neonatal Resuscitation Game or a control group (Controls) with no access to the game'],"['baseline skill performance and MCQ test scores', 'knowledge and skill performance scores', 'knowledge scores']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",162.0,0.0302701,"At the final assessment, declines in knowledge scores were seen in all groups.","[{'ForeName': 'Cheo Lian', 'Initials': 'CL', 'LastName': 'Yeo', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore. yeo.cheo.lian@singhealth.com.sg.'}, {'ForeName': 'Selina Kah Ying', 'Initials': 'SKY', 'LastName': 'Ho', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Vina Canlas', 'Initials': 'VC', 'LastName': 'Tagamolila', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Arunachalam', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Srabani Samanta', 'Initials': 'SS', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Woei Bing', 'Initials': 'WB', 'LastName': 'Poon', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Tan', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Priyantha Ebenezer', 'Initials': 'PE', 'LastName': 'Edison', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Wai Yan', 'Initials': 'WY', 'LastName': 'Yip', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Abdul Alim Abdul', 'Initials': 'AAA', 'LastName': 'Haium', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Pooja Agarwal', 'Initials': 'PA', 'LastName': 'Jayagobi', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Shrenik Jitendrakumar', 'Initials': 'SJ', 'LastName': 'Vora', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Simrita Kaur', 'Initials': 'SK', 'LastName': 'Khurana', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'John Carson', 'Initials': 'JC', 'LastName': 'Allen', 'Affiliation': 'Duke-NUS Medical School, Singapore 169857, Singapore.'}, {'ForeName': 'Ereno Imelda', 'Initials': 'EI', 'LastName': 'Lustestica', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}]",BMC medical education,['10.1186/s12909-020-02078-5']
2322,32456768,"Erratum corrige: ""Efficacy of tocilizumab monotherapy after response to combined tocilizumab and methotrexate in patients with rheumatoid arthritis: the randomised JUST-ACT study"". J.L. Pablos et al.",,2020,,['patients with rheumatoid arthritis'],"['tocilizumab monotherapy', 'tocilizumab and methotrexate']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",[],,0.0350535,,"[{'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Pablos', 'Affiliation': 'Department of Rheumatology, Instituto de Investigación Hospital 12 de Octubre, Universidad Complutense de Madrid, Spain. jlpablos@h12o.es.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Navarro', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Department of Rheumatology, Hospital Universitario A Coruña, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Román-Ivorra', 'Affiliation': 'Department of Rheumatology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Rheumatology, Hospital de Cruces, Bilbao, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Martín Mola', 'Affiliation': 'Department of Rheumatology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cantalejo', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Fuenlabrada, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Ercole', 'Affiliation': 'Roche Farma, Madrid, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Rivero', 'Affiliation': 'Roche Farma, Madrid, Spain.'}]",Clinical and experimental rheumatology,[]
2323,32456804,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652, a Reversible Fatty Acid Amide Hydrolase Inhibitor, in Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Phase I Study.","PURPOSE


This study aimed to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of ASP3652, a peripherally acting inhibitor of peripheral fatty acid amide hydrolase (FAAH) after 30-, 100-, 300-, 600-, and 900-mg single and 100- and 300-mg BID multiple oral dose in Japanese patients.
METHODS


This was a randomized, double-blind, placebo-controlled, single and multiple oral dose Phase I study in healthy, nonelderly men and elderly men and women. The study consisted of 2 parts: in the single oral dose part, 40 healthy, nonelderly men were randomized to receive placebo or ASP3652; in the multiple oral dose part, 48 enrolled nonelderly men and elderly men and women were randomized to receive placebo or ASP3652. In both parts, the investigator judged whether the individuals were healthy based on the results of physical examinations and screening. The safety profile was assessed by examining adverse events, defined as any untoward medical occurrence in an individual administered the study drug and that did not necessarily have a causal relationship with the study treatment; clinical laboratory evaluations; vital signs; the Profile of Mood States scale; and standard 12-lead ECGs and 12-lead ECGs for QT assessment. Pharmacokinetic parameters were estimated using unchanged ASP3652 concentrations in plasma and urine. Pharmacodynamic parameters were estimated using FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations. Safety and tolerability profiles were compared with the placebo group.
FINDINGS


ASP3652 was rapidly absorbed to reach C max  in a single dose and near steady-state at approximately 3 days after the start of multiple dosing. The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg. There was no apparent accumulation based on C max  and AUC 0-12  after multiple doses. Although no differences were found in C max  or AUC 0-12  by age in men, C max  and AUC 0-12  were slightly higher in elderly women than elderly men. FAAH activity was inhibited in a dose-dependent manner, and plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide increased in all dose groups after single and multiple doses of ASP3652. The incidence of adverse events after multiple doses, which ranged from 44.4% to 66.7%, was similar across all treatment groups, including the placebo group.
IMPLICATIONS


Single and multiple doses of ASP3652 were well tolerated and increased endogenous cannabinoids.",2020,The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"['Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women', 'healthy, nonelderly men and elderly men and women', '48 enrolled nonelderly men and elderly men and women', '40 healthy, nonelderly men', 'elderly women than elderly men', 'Japanese patients']","['ASP3652', 'Placebo', 'placebo or ASP3652', 'placebo']","['FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations', 'FAAH activity', 'safety, tolerability, and pharmacokinetic and pharmacodynamic properties', 'Safety and tolerability profiles', 'plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'C max  and AUC of ASP3652', 'incidence of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.131241,The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. Electronic address: masaomi.takizawa@astellas.com.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hatta', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iitsuka', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroishi', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Yanagibashi-Clinical Trial Center, Yanagibashi Hospital, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.021']
2324,32456807,Comorbid anxiety disorders and baseline medication regimens predict clinical outcomes in individuals with co-occurring bipolar disorder and alcohol dependence: Results of a randomized controlled trial.,,2020,,['individuals with co-occurring bipolar disorder and alcohol dependence'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]",[],[],,0.111688,,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Clinical Neurosciences Division, Medical University of South Carolina, Charleston SC. Electronic address: priscian@musc.edu.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Clinical Neurosciences Division, Medical University of South Carolina, Charleston SC.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Clinical Neurosciences Division, Medical University of South Carolina, Charleston SC.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Tolliver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Clinical Neurosciences Division, Medical University of South Carolina, Charleston SC.'}]",Psychiatry research,['10.1016/j.psychres.2020.112904']
2325,32456874,Repair of large traumatic tympanic membrane perforation using ofloxacin otic solution and gelatin sponge.,"INTRODUCTION


Traumatic large tympanic membrane perforations usually fail to heal and require longer healing times. Few studies have compared the healing and hearing outcomes between gelatin sponge patching and ofloxacin otic solution.
OBJECTIVES


To compare the healing outcomes of large traumatic tympanic membrane perforations treated with gelatin sponge, ofloxacin otic solution, and spontaneous healing.
METHODS


Traumatic tympanic membrane perforations >50% of the entire eardrum were randomly divided into three groups: ofloxacin otic solution, gelatin sponge patch and spontaneous healing groups. The healing outcome and hearing gain were compared between the three groups at 6 months.
RESULTS


A total of 136 patients with large traumatic tympanic membrane perforations were included in analyses. The closure rates were 97.6% (40/41), 87.2% (41/47), and 79.2% (38/48) in the ofloxacin otic solution, gelatin sponge patch, and spontaneous healing groups, respectively (p=0.041). The mean times to closure were 13.12±4.61, 16.47±6.24, and 49.51±18.22 days in these groups, respectively (p<0.001).
CONCLUSIONS


Gelatin sponge patch and ofloxacin otic solution may serve as effective and inexpensive treatment strategies for traumatic large tympanic membrane perforations. However, ofloxacin otic solution must be self-applied daily to keep the perforation edge moist, while gelatin sponge patching requires periodic removal and re-patching.",2020,"The closure rates were 97.6% (40/41), 87.2% (41/47), and 79.2% (38/48) in the ofloxacin otic solution, gelatin sponge patch, and spontaneous healing groups, respectively (p=0.041).","['50% of the entire eardrum', '136 patients with large traumatic tympanic membrane perforations', 'Traumatic tympanic membrane perforations']","['gelatin sponge patching and ofloxacin otic solution', 'ofloxacin otic solution, gelatin sponge patch and spontaneous healing groups', 'ofloxacin otic solution and gelatin sponge', 'Gelatin sponge patch and ofloxacin otic solution', 'gelatin sponge, ofloxacin otic solution', 'ofloxacin otic solution', 'ofloxacin otic solution, gelatin sponge patch']","['healing outcomes', 'healing and hearing outcomes', 'closure rates', 'mean times to closure', 'healing outcome and hearing gain']","[{'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0585355', 'cui_str': 'Traumatic tympanic membrane perforation'}]","[{'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0441615', 'cui_str': 'Patching - action'}, {'cui': 'C1251677', 'cui_str': 'Ofloxacin Otic Solution'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",136.0,0.0453084,"The closure rates were 97.6% (40/41), 87.2% (41/47), and 79.2% (38/48) in the ofloxacin otic solution, gelatin sponge patch, and spontaneous healing groups, respectively (p=0.041).","[{'ForeName': 'Xiuguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Jining NO.1 People's Hospital, Department of Otolaryngology, Shandong Province, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Jining Medical University, Department of Histology and Embryology, Shandong Province, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Jining NO.1 People's Hospital, Department of Otolaryngology, Shandong Province, China. Electronic address: yuanyuan2019102@126.com.""}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2020.03.007']
2326,32456877,[Validity and reliability of the Niño Jesús Hospital procedural sedation-analgesia scale of the under deep sedation-analgesia].,"INTRODUCTION


The procedural sedation scale of the Niño Jesús Hospital (Madrid) (SSPNJH) has not been validated.
PATIENTS AND METHODS


A prospective analytical study was conducted in 2 hospitals on patients ≥ 6 months undergoing invasive procedures using sedation-analgesia with propofol or midazolam and fentanyl. All were monitored using the bispectral index (BIS). Videos were made of each procedure, which were then edited and randomised. A total of 150 videos were rated by four observers using the SSPNJH, the sedation scale of the University of Michigan (UMSS), and the Ramsay Scale (SR). These observers were blinded to the BIS, and at the time of drug administration. To assess test-retest reliability, 50 of the initial 150 randomly selected videos were re-assessed.
RESULTS


The study included a total of 65 patients. The within-observer agreement was high (ρ = 0.793). The SSPNJH gave a good interobserver reliability when compared with the UMSS (ICC = 0.88) and the SR (ICC = 0.86), and there was none with the BIS. Internal consistency was moderate (α = 0.68). Construct validity was demonstrated by changes in scores after administering sedatives (p < 0.0001). The SSPNJH had a very low correlation with the BIS (r = -0.166), and a moderate correlation with the UMSS (r = 0.497) and the SR (r = 0.405). As regards the applicability, this scale has been used in two hospitals in five different areas by four professionals of different categories.
CONCLUSIONS


The SSPNJH is valid, reliable and applicable for sedation monitoring in invasive procedures under deep sedation-analgesia in paediatric patients. The SSPNJH has worse properties than the UMSS and the SR.",2020,"The SSPNJH gave a good interobserver reliability when compared with the UMSS (ICC = 0.88) and the SR (ICC = 0.86), and there was none with the BIS.","['2 hospitals on patients ≥\xa06 months undergoing invasive procedures using sedation-analgesia with', 'two hospitals in five different areas by four professionals of different categories', 'paediatric patients', '65 patients']",['propofol or midazolam and fentanyl'],"['sedation scale of the University of Michigan (UMSS), and the Ramsay Scale (SR', 'bispectral index (BIS', 'procedural sedation scale']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]",150.0,0.0185357,"The SSPNJH gave a good interobserver reliability when compared with the UMSS (ICC = 0.88) and the SR (ICC = 0.86), and there was none with the BIS.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lozano-Díaz', 'Affiliation': 'Servicio de Pediatría, Hospital General La Mancha Centro, Alcázar de San Juan, Ciudad Real, España. Electronic address: david.lodi15@gmail.com.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Valdivielso Serna', 'Affiliation': 'Unidad de Analgesia y Sedación, Hospital Universitario Niño Jesús, Madrid, España.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Garrido Palomo', 'Affiliation': 'Servicio de Pediatría, Hospital General La Mancha Centro, Alcázar de San Juan, Ciudad Real, España.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Arias-Arias', 'Affiliation': 'Unidad de Investigación, Hospital General La Mancha Centro, Alcázar de San Juan, Ciudad Real, España.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Tárraga López', 'Affiliation': 'Universidad de Castilla-La Mancha, Albacete, España.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martínez Gutiérrez', 'Affiliation': 'Servicio de Pediatría, Hospital General Universitario de Albacete, Albacete, España.'}]","Anales de pediatria (Barcelona, Spain : 2003)",['10.1016/j.anpedi.2020.04.009']
2327,32443036,Effectivity of Pancreatic Enzyme Replacement Therapy in Malnourished Children.,"OBJECTIVE


Malnutrition is commonly seen in children with exocrine pancreatic insufficiency (EPI). Pancreatic enzyme replacement therapy (PERT) is the mainstay treatment of acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis). The effectiveness of PERT in children with malnutrition without any chronic disease, however, remains unclear. The aim of this study was to investigate the effectiveness of PERT on weight gain and EPI in children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification.
MATERIALS AND METHODS


The study included a total of 40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification. The patients were randomly divided into 2 groups: PERT group (n = 20) received 2000 U lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only. In both groups, anthropometric measurements and the assessment of fecal elastase-1 (FE-1) levels were performed both at first admission and at the end of the 8-week treatment period.
RESULTS


On the basis of WHO classification, 10 (25%) children were classified as severely malnourished and 30 (75%) children as moderately malnourished. EPI was detected in all the patients, among whom 24 (60%) patients had severe EPI. At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels. Similarly, no significant difference was found between pre- and posttreatment measurements of PERT and control groups (P > 0.05) and between pre- and posttreatment measurements of patients with moderate and severe malnutrition (P > 0.05).
CONCLUSIONS


Malnutrition remains a serious public health problem, and thus, the development of novel treatment methods is highly essential. PERT is one of the most commonly considered alternatives, although there is little documentation of PERT in the literature. In the present study, although PERT resulted in higher weight gain, it established no significant difference between the 2 groups.",2020,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","['children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification', 'children with exocrine pancreatic insufficiency (EPI', '40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification', 'acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis', 'Malnourished Children', 'children with malnutrition without any chronic disease']","['2000\u200aU lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only', 'Pancreatic Enzyme Replacement Therapy', 'Pancreatic enzyme replacement therapy (PERT', 'PERT']","['body weight, height, and body mass index (BMI', 'fecal elastase-1 (FE-1) levels', 'weight gain', 'severe malnutrition', 'severe EPI', 'weight gain and EPI', 'waist circumference (WC) and FE-1 levels', 'EPI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4523842', 'cui_str': 'Pancreatic enzyme replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1272315', 'cui_str': 'Fecal elastase 1 level'}]",40.0,0.0311251,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Güven', 'Affiliation': 'Department of Pediatric Gastroenterology, Karadeniz Technical University Faculty of Medicine, Trabzon.'}, {'ForeName': 'Mevsim', 'Initials': 'M', 'LastName': 'Demir Mis', 'Affiliation': 'Department of Pediatrics, Van Yuzuncu Yil University Faculty of Medicine, Van.'}, {'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Karaman', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Akkiz', 'Initials': 'A', 'LastName': 'Şahin Yaşar', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002689']
2328,32443067,Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],['Opioid Analgesia'],[],"[{'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",[],,0.170735,,"[{'ForeName': 'Zoe M', 'Initials': 'ZM', 'LastName': 'Feld', 'Affiliation': 'University of California, Davis, Davis, California A.T. Still University School of Osteopathic Medicine in Arizona, Mesa, Arizona University of California, Davis, Davis, California.'}, {'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Etemadi', 'Affiliation': ''}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003904']
2329,32443068,Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],['Opioid Analgesia'],[],"[{'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",[],,0.170735,,"[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Clure', 'Affiliation': 'Division of Family Planning, Department of Obstetrics & Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Guiahi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003905']
2330,32443695,The Effects of  Aronia melanocarpa  Juice Consumption on the mRNA Expression Profile in Peripheral Blood Mononuclear Cells in Subjects at Cardiovascular Risk.,"Foods and food products that contain polyphenols are proposed to modulate risk of cardiovascular disease. The aim of this three-arm, crossover, randomized, double-blind, placebo-controlled intervention study was to examine the impact of  Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols) dose, on the transcriptome in peripheral blood mononuclear cells (PBMC) of 19 subjects at cardiovascular risk. Transcriptome data were obtained by microarray. Bioinformatic functional annotation analysis was performed on both the whole transcriptome datasets and the differentially expressed genes (DEGs). Expression of selected DEGs was validated by RT-qPCR. Administration of AMJ and dAMJ treatments during the two consecutive four-week treatment periods had additive effects on PBMC transcriptome profiles, with the most pronounced and specific effect noticed for AMJ in the last treatment period (TP3) of the trial. Between the high-dose and low-dose treatments in TP3, there was a multitude of overlapping DEGs and DEG-enriched biological processes and pathways, which primarily included immunomodulation and regulation of cell proliferation/death. Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR. The results suggest the immunomodulatory effects of prolonged habitual consumption of polyphenol-rich aronia juice in individuals at cardiovascular risk.",2020,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","['individuals at cardiovascular risk', '19 subjects at cardiovascular risk', 'Subjects at Cardiovascular Risk']","['Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols', 'AMJ and dAMJ', 'polyphenol-rich aronia juice', 'Aronia melanocarpa  Juice Consumption', 'placebo']","['peripheral blood mononuclear cells (PBMC', 'Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3', 'Peripheral Blood Mononuclear Cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1449661', 'cui_str': 'Aronia melanocarpa'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517446', 'cui_str': '0.29'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1215581', 'cui_str': 'Aronia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1448758', 'cui_str': 'RGS1 protein, human'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0075032', 'cui_str': 'splenotritin'}]",19.0,0.0972833,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","[{'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stojković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jovanović', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Zivković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Zec', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Djurić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Zivotić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kuveljić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kolaković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kolić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Djordjević', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Glibetić', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Alavantić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Stanković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}]",Nutrients,['10.3390/nu12051484']
2331,32443744,Effectiveness of A Pilates Training Program on Cognitive and Functional Abilities in Postmenopausal Women.,"The purpose of this study was to determine the effects of a Pilates exercises program on the cognitive and physical functioning of older Spanish women. This study is a randomized clinical trial; a total of 110 women aged ≥60 years were initially allocated to either a Pilates group (PG, n = 55), who underwent a 12-week Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention. Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test) were assessed before and immediately after the intervention period. The main findings of this study suggest that women in the PG (within-group differences) experienced improvements across all the variables examined except for global cognitive function. When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test). In conclusion, our results suggest that Pilates has the potential to improve both cognitive and functional abilities among Spanish women aged 60 years and over.",2020,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","['Spanish women aged 60 years and over', 'Postmenopausal Women', '110 women aged ≥60 years', 'older Spanish women']","['Pilates Training Program', 'Pilates exercises program', 'Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention']","['cognitive and functional abilities', 'global cognitive function and functional flexibility (Back Scratch Test', 'global cognitive function', 'Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test', 'Cognitive and Functional Abilities', 'cognitive and physical functioning']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0430562', 'cui_str': 'Scratch test'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",110.0,0.0263371,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","[{'ForeName': 'Patricia Alexandra', 'Initials': 'PA', 'LastName': 'García-Garro', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Hita-Contreras', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'José Daniel', 'Initials': 'JD', 'LastName': 'Jiménez-García', 'Affiliation': 'Department of Teaching Physical Education, Fine Arts and Music, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cruz-Díaz', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103580']
2332,32443843,Effect of Exclusive Primer and Adhesive on Microtensile Bond Strength of Self-Adhesive Resin Cement to Dentin.,"The aim of this study was to investigate the effect of G-CEM One Primer (GCOP) and self-etching adhesive on the microtensile bond strength (µTBS) between self-adhesive resin cement G-CEM One (GCO) and dentin. Teeth were sectioned to expose the flat dentin surface and randomly assigned into five groups (n = 15) according to the dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP). The composite resin blocks were bonded to the dentin surface using GCO. The specimens were stored in distilled water at 37 °C for 24 h, then sectioned into sticks (1 mm × 10 mm). The μTBS values were statistically analyzed using 1-way analysis of variance (ANOVA) and Tukey's honestly significant difference (HSD) test ( α  = 0.05) and failure mode was examined under a stereomicroscope. The bonding interface of each specimen was evaluated using confocal laser scanning microscopy. The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05). The use of GCOP with GCO results in the improved µTBS between GCO and dentin. In conclusion, using only GCOP with GCO for bonding of indirect restoration is extremely simple and increasing bond strength.",2020,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).",['Self-Adhesive Resin Cement to Dentin'],"['dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP', 'GCOP', 'G-CEM']","['μTBS values', 'highest µTBS value', 'microtensile bond strength (µTBS']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0045845', 'cui_str': '2-amino-4-phosphonobutyric acid'}, {'cui': 'C0378574', 'cui_str': '2-chloroethyl methyl sulfide'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0204166,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).","[{'ForeName': 'Bit-Na', 'Initials': 'BN', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Son', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Jeong-Kil', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13102353']
2333,30852244,Effects of a behavioural weight loss intervention in people with serious mental illness: Subgroup analyses from the ACHIEVE trial.,"BACKGROUND


Persons with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of obesity and related chronic diseases and die 10-20years earlier than the overall population, primarily due to cardiovascular disease. In the ACHIEVE trial, a behavioural weight loss intervention led to clinically significant weight loss in persons with SMI. As the field turns its attention to intervention scale-up, it is important to understand whether the effectiveness of behavioural weight loss interventions for people with SMI, like ACHIEVE, differ for specific subgroups.
METHODS


This study examined whether the effectiveness of the ACHIEVE intervention differed by participant characteristics (e.g. age, sex, race, psychiatric diagnosis, body mass index) and/or their weight-related attitudes and behaviours (e.g. eating, food preparation, and shopping habits). We used likelihood-based mixed effects models to examine whether the baseline to 18 month effects of the ACHIEVE intervention differed across subgroups.
RESULTS


No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
CONCLUSIONS


These findings suggest that the ACHIEVE behavioural weight loss intervention is broadly applicable to the diverse population of individuals with SMI.",2019,"No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
","['Persons with serious mental illnesses (SMI', 'persons with SMI', 'people with serious mental illness', 'people with SMI']",['behavioural weight loss intervention'],['weight loss'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0385761,"No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
","[{'ForeName': 'Eleanore', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States. Electronic address: ealexa12@jhmi.edu.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Department of Kinesiology, Towson University, Baltimore, MD, 21252, United States.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Stanley Research Program, Sheppard Pratt Health System, Baltimore, MD 21204, United States.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, 91024, United States.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.02.002']
2334,32446208,Absence seizure provocation during routine EEG: Does position of the child during hyperventilation affect the diagnostic yield?,"PURPOSE


When performed correctly, hyperventilation (HV) for three minutes provokes absence seizures in virtually all children, a finding suggestive of a diagnosis of childhood absence epilepsy (CAE). Interestingly, some children experience absence seizures while performing HV in the office yet do not experience absences during HV on subsequent routine EEG. In most instances, HV during routine EEG is performed in the supine position, while in the office HV is done with the child sitting-up. Therefore, we hypothesized that the position in which HV is performed may influence its yield in provoking absence seizures.
METHODS


We conducted a randomized multi-center controlled trial among children (4-10 years old) with suspected CAE. During a routine EEG, children were asked to perform HV twice, in the supine and sitting positions.
RESULTS


Twenty children (four males) diagnosed with CAE were included in the analysis. Seventeen of the 20 patients experienced absence seizures while sitting and 13 experienced seizures during supine HV (p = 0.031). All patients that had absence seizures during supine HV also had seizures during sitting HV. Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042). An opposite tendency was seen in the younger age group (4-7 years), with shorter seizures in the supine HV group (5.6 seconds supine, 7.57 seconds sitting, p = 0.019).
CONCLUSIONS


HV in the sitting position may increase the yield of provoking absence seizures during routine EEGs, thereby improving its sensitivity in the diagnosis of CAE.",2020,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","['children (4-10 years old) with suspected CAE', 'Twenty children (four males) diagnosed with CAE']",['routine EEG'],"['sitting HV', 'seizure duration', 'shorter seizures', 'absence seizures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}]",20.0,0.0300237,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Rozenblat', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: tal.hakim@gmail.com.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Kraus.dror@gmail.com.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mahajnah', 'Affiliation': 'Institute, Hillel Yaffe Medical Center, The Ruth and Bruce Rappaport Faculty of medicine, Technion University, Israel. Electronic address: MohamedM@hy.health.gov.il.'}, {'ForeName': 'Hadassah', 'Initials': 'H', 'LastName': 'Goldberg-Stern', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Hagoldberg@clalit.org.il.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Watemberg', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: watembergn@walla.co.il.'}]",Seizure,['10.1016/j.seizure.2020.03.013']
2335,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8']
2336,32449684,Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them.
OBJECTIVE


This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only.
METHODS


This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point.
RESULTS


The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations.
CONCLUSIONS


The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/14309.",2020,"The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
","['Major Depressive Disorder', '120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada', 'major depressive disorder (MDD', 'participants with MDD', 'accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines']","['CBT plus TAU, group exercise three times a week plus TAU, or only TAU', 'group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU', 'cognitive behavioral therapy (CBT) and physical exercise', 'CBT and exercise', 'Group Cognitive Behavioral Therapy and Exercise']",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]",[],120.0,0.114613,"The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Yekrang Safakar', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hrabok', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Urichuk', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juhas', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Shalaby', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Devashree', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chue', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Tchida', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kelland', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Coulson', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Sosdjan', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hay', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Lesage', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Paulsen', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Delday', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Sherianna', 'Initials': 'S', 'LastName': 'Duiker', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Surood', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abba-Aji', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vincent Israel Opoku', 'Initials': 'VIO', 'LastName': 'Agyapong', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/14309']
2337,32449690,Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic Randomized Controlled Trial.,"BACKGROUND


Patient self-monitoring via mobile phones during psychotherapy can enhance and provide an overview of psychotherapeutic progress by graphically displaying current and previous symptom scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team.
OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD). Dialectical behavior therapy will be performed to treat BPD. The primary outcome is the mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder.
METHODS


This study is a pragmatic, multicenter randomized controlled trial. Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark. Patients are randomly assigned, on a 1:1 basis, to either the mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition. Patients will complete several self-report questionnaires on symptom severity; assessments by trained raters on BPD severity will be performed as well. Survival analysis with a shared frailty model will be used to assess the primary outcome.
RESULTS


Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited. The study ended in February 2020. It is expected that the benefits of mobile phone-based self-report compared to the pen-and-paper method will be demonstrated for skill learning speed and registration compliance. To our knowledge, this is the first trial exploring the impact of cloud-based mobile registration in BPD treatment.
CONCLUSIONS


This trial will report on the effectiveness of mobile phone-based self-monitoring during psychiatric treatment. It has the potential to contribute to evidence-based clinical practice since apps are already in use clinically.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191565; https://clinicaltrials.gov/ct2/show/NCT03191565.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17737.",2020,"OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD).","['Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark', 'patients with borderline personality disorder (BPD', 'Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited', 'Patients With Borderline Personality Disorder']","['mobile phone-based self-monitoring', 'Daily Self-Monitoring of Symptoms and Skills Learning', 'mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition', 'mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy', 'Dialectical behavior therapy']",['mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder'],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1564509', 'cui_str': 'Or-pen'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.257132,"OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD).","[{'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Helweg-Jørgensen', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Beck Lichtenstein', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Fruzzetti', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Møller Dahl', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Institute of Psychology, University of Southern Denmark, Odense, Denmark.'}]",JMIR research protocols,['10.2196/17737']
2338,32449697,The effects of empagliflozin versus metformin on endothelial microparticles in overweight/obese women with polycystic ovary syndrome.,"CONTEXT


Endothelial microparticles (EMPs) are novel, surrogate biomarkers of endothelial function and have been shown to be elevated in women with polycystic ovary syndrome (PCOS). It remains poorly understood how pharmacological options for managing PCOS affect EMP levels.
OBJECTIVE


To characterise and compare the effects of empagliflozin vs. metformin on the circulating levels of EMPs in overweight/ obese women with PCOS.
METHODS


This was a randomised, comparative, 12-week single-centre trial conducted at the Academic Diabetes, Endocrinology and Metabolism Research Centre, Hull, UK. This analysis includes data from thirty-nine overweight/obese women with PCOS who completed the study and were randomised to empagliflozin (15 mg/day) (n = 19) or metformin (1500 mg/day) (n = 20). Blood samples were collected at baseline and 12 weeks after treatment and analysed for specific surface proteins expressed by circulating EMPs using flow cytometry.
RESULTS


In the empagliflozin group, ICAM-1 (p=0.006), E-selectin (p=0.016) and VCAM-1 (p=0.001) EMPs increased significantly following 12 weeks of treatment, but no changes were seen in PECAM-1 (p=0.93) or endoglin (p=0.13) EMPs. In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged. When data were expressed as the percentage change from baseline in each group, no significant differences were seen between groups for any biomarker (p-values from 0.22 to 0.80).
CONCLUSIONS


Short-term administration of empagliflozin and metformin in overweight/obese women with PCOS appear to increase EMPs expressed by endothelial cells during their activation.",2020,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","['overweight/obese women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'overweight/obese women with polycystic ovary syndrome', 'overweight/ obese women with PCOS', 'thirty-nine overweight/obese women with PCOS who completed the study']","['empagliflozin vs. metformin', 'empagliflozin and metformin', 'empagliflozin', 'metformin']","['circulating levels of EMPs', 'VCAM-1 EMPs', 'E-selectin', 'Blood samples', 'ICAM-1', 'VCAM-1 (p=0.001) EMPs', 'endothelial microparticles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}]",,0.10233,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Javed', 'Affiliation': 'Z Javed, Academic Diabetes Endocrinology and Metabolism, University of Hull, Hull, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papageorgiou', 'Affiliation': 'M Papageorgiou, Department of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology, and Immunology, Medical University of Vienna, Vienna, Austria, Vienna, Austria.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'L Madden, Biomedical Science, University of Hull, Hull, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'A Rigby, Hull York Medical School, Hull, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Kilpatrick', 'Affiliation': 'E Kilpatrick, Clinical Biochemistry, Sidra Medical and Research Center, Doha, Qatar.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'S Atkin, Research, Royal College of Surgeons in Ireland and Medical University of Bahrain, Bahrain, Bahrain.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'T Sathyapalan, Hull York Medical School, University of Hull, Hull, HU32RW, United Kingdom of Great Britain and Northern Ireland.'}]",Endocrine connections,['10.1530/EC-20-0173']
2339,32449716,Combining Behavior and EEG to Study the Effects of Mindfulness Meditation on Episodic Memory.,"Although there has been recent interest in how mindfulness meditation can affect episodic memory as well as brain structure and function, no study has examined the behavioral and neural effects of mindfulness meditation on episodic memory. Here we present a protocol that combines mindfulness meditation training, an episodic memory task, and EEG to examine how mindfulness meditation changes behavioral performance and the neural correlates of episodic memory. Subjects in a mindfulness meditation experimental group were compared to a waitlist control group. Subjects in the mindfulness meditation experimental group spent four weeks training and practicing mindfulness meditation. Mindfulness was measured before and after training using the Five Facet Mindfulness Questionnaire (FFMQ). Episodic memory was measured before and after training using a source recognition task. During the retrieval phase of the source recognition task, EEG was recorded. The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training. In addition, increases in mindfulness correlated with increases in theta power in right frontal channels. Therefore, results obtained from combining mindfulness meditation training, an episodic memory task, and EEG reveal the behavioral and neural effects of mindfulness meditation on episodic memory.",2020,"The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training.",[],"['Mindfulness Meditation', 'mindfulness meditation experimental group spent four weeks training and practicing mindfulness meditation', 'mindfulness meditation training, an episodic memory task, and EEG to examine how mindfulness meditation', 'mindfulness meditation', 'waitlist control group']","['episodic memory', 'Episodic memory', 'Episodic Memory', 'mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]",,0.0109079,"The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nyhus', 'Affiliation': 'Department of Psychology, Bowdoin College; Program in Neuroscience, Bowdoin College; enyhus@bowdoin.edu.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Engel', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}, {'ForeName': 'Tomas Donatelli', 'Initials': 'TD', 'LastName': 'Pitfield', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}, {'ForeName': 'Isabella M W', 'Initials': 'IMW', 'LastName': 'Vakkur', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}]",Journal of visualized experiments : JoVE,['10.3791/61247']
2340,32446880,Changes in parental feeding practices and preschoolers' food habits following a randomized controlled childhood obesity trial.,"Childhood obesity treatment involving parents is most effective during the preschool age. However, the mechanisms of change are not known. The present study reports on secondary outcomes (changes in parental feeding practices and child food habits) of early obesity treatment. The More and Less study is a randomized controlled trial conducted in Stockholm County, Sweden. Children with obesity (n = 174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree) were randomized to: 1) standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB). The Child Feeding Questionnaire (CFQ) was used to measure parental feeding practices. Child food habits were assessed with a Food Frequency Questionnaire (FFQ). We calculated the monthly changes in CFQ practices and FFQ items based on four measurements. We did not find any significant between-group differences in parental feeding practices and child food habits over time. However, general linear models showed that changes in certain feeding practices predicted changes in child food habits. When ST was compared to the parent support groups, some associations moved in opposite directions. For example, increasing maternal restriction predicted increased consumption of cookies/buns in PGNB (b = 2.3, p < 0.05) and decreased consumption of cookies/buns in ST (b = -2.1, p < 0.05). This is the first study to examine the effect of parental feeding practices on child food habits and weight status after obesity treatment among preschoolers. We found no evidence that changes in feeding practices or changes in child food habits mediated child weight loss. Future studies should consider other intermediary processes related to general parenting practices and parent-child interactions.",2020,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"['Children with obesity (n\u202f=\u202f174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree', 'child food habits and weight status after obesity treatment among preschoolers', 'Stockholm County, Sweden']","['standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB', 'parental feeding practices']","['Food Frequency Questionnaire (FFQ', 'parental feeding practices and child food habits) of early obesity treatment', 'consumption of cookies/buns in ST', 'Child Feeding Questionnaire (CFQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",,0.0264302,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Somaraki', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: maria.somaraki@ikv.uu.se.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Unit for Biocultural Variation and Obesity, School of Anthropology and Museum Ethnography, University of Oxford, Oxford, UK; Social Science and Systems in Health, Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, England, UK. Electronic address: karin.eli@anthro.ox.ac.uk.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Sorjonen', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden. Electronic address: kimmo.sorjonen@ki.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: anna.ek@ki.se.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sandvik', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: pernilla.sandvik@ikv.uu.se.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden; Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: paulina.nowicka@ikv.uu.se.'}]",Appetite,['10.1016/j.appet.2020.104746']
2341,32446881,Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT).,"BACKGROUND


The NIH-funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stable patients age ≥50 who were ≥6 months post myocardial infarction to 40 infusions of an edetate disodium-based regimen or placebo. In 633 patients with diabetes, edetate disodium significantly reduced the primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.44-0.79, p < 0.001). The principal secondary endpoint of a composite of cardiovascular death, myocardial infarction, or stroke was also reduced (HR 0.60, 95% CI 0.39-0.91, p = 0.017). It is unknown if the treatment effect differs by diabetes therapy.
METHODS


We grouped the subset of 633 patients with diabetes according to glucose-lowering therapy at time of randomization. The log-rank test was used to compare active therapy versus placebo. All treatment comparisons were performed using 2-sided significance tests at the significance level of 0.05 and were as randomized. Relative risks were expressed as HR with associated 95% CI, calculated using the Cox proportional hazards model.
RESULTS


There were 162 (25.7%) patients treated with insulin; 301 (47.5%) with oral hypoglycemics only; and 170 (26.8%) receiving no pharmacologic treatment for diabetes. Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%) (HR 1.56, 95% CI 1.07-2.27, p = 0.022)] or oral hypoglycemics [61 (38%) vs 87 (29%) (HR 1.46, 1.05-2.03, p = 0.024)]. The primary endpoint occurred less frequently with edetate disodium based therapy versus placebo in patients on insulin [19 (26%) vs 42 (48%) (HR 0.42, 95% CI 0.25-0.74, log-rank p = 0.002)], marginally in patients on oral hypoglycemics [38 (25%) vs 49 (34%) (HR 0.66, 95% CI 0.43-1.01, log-rank p = 0.041)], and no significant difference in patients not treated with a pharmacologic therapy [23 (25%) vs 26 (34%) (HR 0.69, 95% CI 0.39-1.20, log-rank p = 0.225)]. The interaction between randomized intravenous treatment and type of diabetes therapy was not statistically significant (p = 0.203).
CONCLUSIONS


Edetate disodium treatment in stable, post-myocardial infarction patients with diabetes suggests that patients on insulin therapy at baseline may accrue the greatest benefit.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov identifier: http://clinicaltrials.gov/ct2/show/NCT00044213?term=TACT&rank=7 identifier Trial to Assess Chelation Therapy (TACT), NCT00044213.",2020,Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%),"['633 patients with diabetes according to glucose-lowering therapy at time of randomization', 'post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT', '1708 stable patients age ≥50 who were ≥6\u202fmonths post myocardial infarction to 40 infusions of an', '633 patients with diabetes']","['edetate disodium', 'placebo', 'Chelation Therapy (TACT', 'edetate disodium-based regimen or placebo', 'disodium']","['oral hypoglycemics', 'primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina', 'composite of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0012695', 'cui_str': 'sodium edetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1708.0,0.261821,Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%),"[{'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Escolar', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ujueta', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Nahin', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goertz', 'Affiliation': 'Duke Department of Orthopaedic Surgery, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America. Electronic address: gervasio.lamas@msmc.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107616']
2342,32446921,Clinical assessment of perfusion techniques during surgical repair of coarctation of aorta with aortic arch hypoplasia in neonates: a pilot prospective randomized study.,"OBJECTIVE


We aimed to compare the safety and efficacy of three perfusion methods primarily used in aortic arch reconstruction in infants, namely, deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation.
METHODS


Forty-five infants with aortic arch obstruction and biventricular anatomy were enrolled in this pilot prospective study (ClinicalTrials.gov registration number: NCT02835703). Patients were randomly assigned into three groups according to the perfusion strategy (deep hypothermic circulatory arrest, n=15; selective antegrade cerebral perfusion, n=15; double arterial cannulation, n=15). The primary composite endpoint was the incidence of adverse events in the early postoperative period (acute kidney injury [KDIGO criteria], new brain MRI findings, and in-hospital mortality). The secondary endpoints were intensive care unit length of stay, vasoactive-inotropic score index, and cardiopulmonary bypass duration. All patients underwent aortic arch reconstruction under cardiopulmonary bypass and were monitored with near infrared spectroscopy during surgery.
RESULTS


No significant differences in the baseline characteristics and cardiopulmonary bypass duration were observed among the groups. The incidence of unfavorable events was lower in the double arterial cannulation group (p=0.041). Acute kidney injury was observed in 8, 6, and 5 patients from the deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation groups, respectively (p=0.64). Twelve patients from the deep hypothermic circulatory arrest group had new brain MRI findings (p=0.019). There were 5 in-hospital deaths with no significant difference among the groups (p=0.70). The ""head"" and ""lumbar"" values on near infrared spectroscopy during aortic arch reconstruction were significantly higher in the selective antegrade cerebral perfusion and double arterial cannulation groups than in the deep hypothermic circulatory arrest group. Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (p=0.03). Vasoactive-inotropic score index >12 was found to be a risk factor for acute kidney injury and early mortality.
CONCLUSIONS


Continuous regional perfusion during aortic arch reconstruction decreases the risk of new brain MRI findings in infants and the need for postoperative inotropic support. Although values of near infrared spectroscopy during the procedure were significantly higher with continuous perfusion strategies, these methods do not reduce the acute kidney injury incidence compared to that with deep hypothermic circulatory arrest. Double arterial cannulation significantly reduces the need for inotropic support.",2020,Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (p=0.03).,"['surgical repair of coarctation of aorta with aortic arch hypoplasia in neonates', 'Forty-five infants with aortic arch obstruction and biventricular anatomy']","['perfusion strategy (deep hypothermic circulatory arrest, n=15; selective antegrade cerebral perfusion, n=15; double arterial cannulation', 'aortic arch reconstruction under cardiopulmonary bypass']","['hospital deaths', 'new brain MRI findings', 'intensive care unit length of stay, vasoactive-inotropic score index, and cardiopulmonary bypass duration', 'safety and efficacy', 'vasoactive-inotropic score index', 'incidence of unfavorable events', 'deep hypothermic circulatory arrest, selective antegrade cerebral perfusion', 'acute kidney injury incidence', 'Acute kidney injury', 'baseline characteristics and cardiopulmonary bypass duration', 'incidence of adverse events in the early postoperative period (acute kidney injury [KDIGO criteria], new brain MRI findings, and in-hospital mortality']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0003492', 'cui_str': 'Coarctation of aorta'}, {'cui': 'C0265881', 'cui_str': 'Congenital hypoplasia of aortic arch'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3164271', 'cui_str': 'Obstruction of aortic arch'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1564655', 'cui_str': 'Deep Hypothermic Circulatory Arrest'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0003489', 'cui_str': 'Aortic arch structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1564655', 'cui_str': 'Deep Hypothermic Circulatory Arrest'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",45.0,0.116031,Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (p=0.03).,"[{'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Kulyabin', 'Affiliation': 'Department of pediatric cardiac surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia. Electronic address: y.y.coolyabin@gmail.com.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'Department of heart valve disease, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Soynov', 'Affiliation': 'Department of pediatric cardiac surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Omelchenko', 'Affiliation': 'Department of pediatric cardiac surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Zubritskiy', 'Affiliation': 'Department of pediatric cardiac surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Gorbatykh', 'Affiliation': 'Department of pediatric cardiac surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.04.015']
2343,32446951,Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: the multicenter double-blind placebo-controlled three-armed randomized Dutch DEXA study.,"PURPOSE


After radiotherapy for painful bone metastases up to 44% of patients report a pain flare (PF). Our study compared two dose schedules of dexamethasone versus placebo to prevent PF.
METHODS AND MATERIALS


This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive A: 8 mg dexamethasone before radiotherapy, followed by three daily doses, B: 8 mg dexamethasone followed by three doses of placebo, or C: four doses of placebo. Patients reported worst pain scores, study medication side effects and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a two-point increase on a 0-10 pain scale with no decrease in opioid intake, or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or below. The primary analysis was by intention-to-treat with patients with missing data classified as having a PF.
RESULTS


From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for A, 27% for B, and 39% for C (p= 0.07). Although patients in group B had the lowest PF-incidence, a relatively high percentage did not return to baseline pain levels indicating pain progression. The mean duration of PF was 2.1 days for A, 4.5 days for B and 3.3 days for C (p= 0.0567). Dexamethasone postponed PF occurrence: in A, 52% occurred on day 2-5 vs. 73% in B and 99% in C (p=0.02). Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001). Side effects were similar.
CONCLUSIONS


There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on day 2-5.",2020,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"['patients with painful bone metastases from solid tumors randomly to receive A: 8 mg', 'painful bone metastases', 'From January 2012 to April 2016, 295 patients were randomized', 'painful bone metastases up to 44% of patients report a pain flare (PF']","['radiotherapy', 'dexamethasone', 'dexamethasone before radiotherapy', 'Dexamethasone', 'palliative radiotherapy', 'placebo']","['mean duration of PF', 'PF incidence', 'incidence of radiation-induced PF', 'Side effects', 'mean pain scores', 'opioid intake', 'PF', 'pain score', 'worst pain scores, study medication side effects and opioid intake', 'PF occurrence', 'lowest PF-incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",295.0,0.596742,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"[{'ForeName': 'Yvette M', 'Initials': 'YM', 'LastName': 'van der Linden', 'Affiliation': '- Dept of Radiotherapy, Leiden University Medical Centre, Leiden, The Netherlands; - Centre of Expertise in Palliative Care, Leiden University Medical Centre, Leiden, The Netherlands. Electronic address: ymvanderlinden@lumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'Westhoff', 'Affiliation': '- Dept of Radiotherapy, University Medical Centre Utrecht, Utrecht, the Netherlands; -Dept of Radiotherapy, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': '-Dept of Biostatistics, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'van Baardwijk', 'Affiliation': '- MAASTRO, Maastricht, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Vries', 'Affiliation': '-Dept of Radiotherapy, National Cancer Institute, Amsterdam, the Netherlands; -Dept of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': '-Dept of Radiotherapy, Medical Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Wiggenraad', 'Affiliation': '-Dept of Radiotherapy, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bakri', 'Affiliation': '-Dept of Radiotherapy, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Gerda', 'Initials': 'G', 'LastName': 'Wester', 'Affiliation': '-Radiotherapy Group Arnhem, the Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'de Pree', 'Affiliation': '-Dept of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Lieneke', 'Initials': 'L', 'LastName': 'van Veelen', 'Affiliation': '-ZRTI, Vlissingen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Budiharto', 'Affiliation': '-Dept of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Schippers', 'Affiliation': '-Bernard Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Anna Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': '-Dept of Medical Oncology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'de Graeff', 'Affiliation': '-Dept of Medical Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.007']
2344,32457078,"Efficacy of maternal B 12  supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.","INTRODUCTION


Vitamin B 12  deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B 12  deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.
METHODS AND ANALYSIS


This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant's biochemical B 12  status at age 9 months and maternal biochemical B 12  status in the first and third trimesters. Maternal biochemical B 12  status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.
ETHICAL CONSIDERATIONS AND DISSEMINATION


The study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits. Trial registration number CTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov).",2020,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","['Eligible mothers who give written consent', '720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal', 'vegetarian women for improving infant neurodevelopment']","['250 mcg methylcobalamin', 'maternal B 12  supplementation']","[""offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants"", ""infant's biochemical B 12  status at age 9 months and maternal biochemical B 12  status in the first and third trimesters""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]",720.0,0.478247,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","[{'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Nagpal', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Manu Raj', 'Initials': 'MR', 'LastName': 'Mathur', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Nagrath', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heys', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina Borja', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Augustin', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Jageshwor', 'Initials': 'J', 'LastName': 'Gautam', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Pant', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Swabey', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Lakhanpaul', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK m.lakhanpaul@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034987']
2345,32457082,"Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.","INTRODUCTION


Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI.
METHODS AND ANALYSIS


EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis.
ETHICS AND DISSEMINATION


Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.
TRIAL REGISTRATION NUMBER


Registered in the Dutch Trial Register: NL5572.",2020,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","['severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling', 'Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion', 'surgical site infections after elective abdominal surgery (EPOCH']","['EPOCH bundle added to (national) standard care', 'intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control', 'EPOCH added to standard care or standard care only']","['SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up', 'anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness', 'intention-to-treat basis']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.182783,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","[{'ForeName': 'Stijn W', 'Initials': 'SW', 'LastName': 'de Jonge', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wolfhagen', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Quirine Jj', 'Initials': 'QJ', 'LastName': 'Boldingh', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Bom', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Jochem Cg', 'Initials': 'JC', 'LastName': 'Scheijmans', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Bart Mf', 'Initials': 'BM', 'LastName': 'van der Leeuw', 'Affiliation': 'Department of Anesthesiology, Albert Schweitzer Hospital, Dordrecht, Noord-Holland, Netherlands.'}, {'ForeName': 'Joost Ab', 'Initials': 'JA', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Hering', 'Affiliation': 'Anesthesiology, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Dirk Ja', 'Initials': 'DJ', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Surgery, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Otto E', 'Initials': 'OE', 'LastName': 'van Geffen', 'Affiliation': 'Department of Anesthesiology, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Eduard R', 'Initials': 'ER', 'LastName': 'Hendriks', 'Affiliation': 'Department of Surgery, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Ewoud B', 'Initials': 'EB', 'LastName': 'Kluyver', 'Affiliation': 'Department of Anesthesiology, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Demirkiran', 'Affiliation': 'Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Luc Rcw', 'Initials': 'LR', 'LastName': 'van Lonkhuijzen', 'Affiliation': 'Department of Gynaecologic Oncology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Slotema', 'Affiliation': ""Department of Anesthesiology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Werner A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Seppe Jsha', 'Initials': 'SJ', 'LastName': 'Koopman', 'Affiliation': 'Department of Anesthesiology, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'van Rossem', 'Affiliation': 'Department of Surgery, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Over', 'Affiliation': 'Department of Anesthesiology, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Duijvendijk', 'Affiliation': 'Department of Surgery, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Marcel Gw', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands m.a.boermeester@amsterdamumc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-038196']
2346,32457083,"Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO): a prospective, randomised placebo-controlled feasibility trial.","INTRODUCTION


Antimicrobial resistance is rising, largely due to the indiscriminate use of antimicrobials. The human gut is the largest reservoir of antibiotic resistant bacteria (ARB). Individuals colonised with ARB have the potential to spread these organisms both in the community and hospital settings. Infections with ARB such as extended spectrum beta-lactamase producing enterobacteriales (ESBL-E) and carbapenemase producing enterobacteriales (CPE) are more difficult to treat and are associated with an increased morbidity and mortality. Presently, there is no effective decolonisation strategy for these ARB. Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
METHODS AND ANALYSIS


Prospective, randomised, patient-blinded, placebo-controlled feasibility trial of FMT to eradicate gastrointestinal carriage of ARB. Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage will be randomised 1:1 to receive encapsulated FMT or placebo. The primary outcome measure is consent rate (as a proportion of patients who fulfil inclusion/exclusion criteria); this will be used to determine if a substantive trial is feasible. Participants will be followed up at 1 week, 1 month, 3 months and 6 months and monitored for adverse events as well as gastrointestinal carriage rates of ARB after intervention.
ETHICS AND DISSEMINATION


Research ethics approval was obtained by London-City and East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peer-reviewed journal and presented at international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.",2020,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","['number 34\u2009467', 'Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage', 'Faecal microbiota transplant (FMT', 'Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO']","['encapsulated FMT or placebo', 'FMT', 'placebo']","['consent rate', 'gastrointestinal carriage rates of ARB']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C1040967', 'cui_str': 'Order Enterobacterales'}, {'cui': 'C0246081', 'cui_str': 'carbapenemase'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}]","[{'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}]",80.0,0.359758,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Merrick', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': ""Pharmacy Department, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bisnauthsing', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Chi Chi', 'Initials': 'CC', 'LastName': 'Izundu', 'Affiliation': ""Care of Guy's and Saint Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Amos', 'Affiliation': 'National Institute for Biological Standards and Control, Potters Bar, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Department of Infectious Diseases, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Shawcross', 'Affiliation': ""Institute of Liver Studies, Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Goldenberg', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK Simon.Goldenberg@gstt.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2020-038847']
2347,32457106,Open-Label Crossover Oral Bioequivalence PK Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA™-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults.,"SUBA™-itraconazole (S-ITZ) which releases drug in the duodenum compared to conventional ITZ (C-ITZ) in the stomach were compared in two PK studies: a 3-day loading dose and a 15-day steady-state. These were crossover, oral bioequivalence studies under fed conditions in healthy adult volunteers. In the loading dose study, C-ITZ (2x100 mg) and S-ITZ (2x65 mg) were administered TID for 3 days and once on day 4 (N=15). For the steady-state study, C-ITZ (2x100 mg) and S-ITZ (2x65 mg) were administered BID for 14 days and a last dose 30min after a meal on day 15 (N=16). Blood samples collected throughout both studies were analyzed for ITZ and hydroxy-ITZ (OH-ITZ) levels. Least-squares-geometric means were used to compare C max,ss , C trough  and AUC tau  of each formulation. Ratios of ITZ and OH-ITZ for S-ITZ to C-ITZ were between 107% to 118% in both studies for C max,ss , C trough  and AUC tau , within the FDA-required bioequivalence range of 80-125%. At the end of the steady-state study, 13 of 16 volunteers obtained higher mean C trough  ITZ blood levels >1000ng/mL when administered S-ITZ (81%)  vs  C-ITZ (44%). The study drugs were well-tolerated in both studies with similar AEs. All treatment emergent AEs resolved after study completion. One C-ITZ volunteer discontinued due to an treatment unrelated AE in the steady-state study. No SAEs were reported. Total, trough and peak ITZ and OH-ITZ exposure were similar between formulations. Therefore, SUBA™-ITZ was bioequivalent to C-ITZ in healthy adult volunteers with 35% less drug and exhibited a similar safety profile.",2020,"Total, trough and peak ITZ and OH-ITZ exposure were similar between formulations.","['healthy adult volunteers', 'Healthy Adults']","['SUBA™-Itraconazole and Conventional Itraconazole Capsules', 'C-ITZ (2x100 mg) and S-ITZ', 'conventional ITZ (C-ITZ', 'SUBA™-itraconazole']","['mean C trough  ITZ blood levels ', 'Total, trough and peak ITZ and OH-ITZ exposure', 'Ratios of ITZ and OH-ITZ for S-ITZ to C-ITZ']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1244751', 'cui_str': 'Itraconazole Oral Capsule'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",,0.0196089,"Total, trough and peak ITZ and OH-ITZ exposure were similar between formulations.","[{'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Thompson', 'Affiliation': 'UC Davis School of Medicine, Department of Internal Medicine Division of Infectious Diseases and Department of Medical Microbiology and Immunology, Sacramento, CA.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Lewis', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, Inc., Raleigh, NC.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Mudge', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, LLC., Melbourne, Australia.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'University of Texas Health Science Center, Division of Infectious Diseases, San Antonio, TX.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Burnett', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, Inc., Raleigh, NC bruce.burnett@maynepharma.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00400-20']
2348,32457630,Non-Targeted Metabolomic Profiling of Coronary Heart Disease Patients With Taohong Siwu Decoction Treatment.,"Traditional Chinese medicine is one of the complementary and alternative therapies to improve the prognosis of coronary heart disease (CHD). Taohong Siwu Decoction (THSWD), a classical traditional Chinese medication that promotes blood circulation, is clinically beneficial in CHD. However, the underlying mechanism of THSWD is still unclear. To comprehensively understand the material foundation of the ""blood"", it is significantly important to study the differential metabolites involved in the treatment of CHD with Chinese medicinal herb promoting blood circulation in TCM theory. Hence, this study investigated the metabolic profiles of the serum in CHD patients to determine the differential metabolites between the THSWD group and the placebo group. Eleven CHD patients were recruited and divided into two groups randomly and double-blindly. Serum samples were determined by performing non-targeted ultra-performance liquid chromatography with tandem mass spectrometry-based metabolomics. Pearson's correlation analysis was used to assess the association between identified metabolites and clinical serum indexes of CHD. Based on the result, a total of 513 metabolites were found in the serum of CHD patients, of which 27, involved in 29 metabolic pathways, were significantly different between the two groups. Among the differential metabolites, THSWD upregulated succinylcarnitine in fatty acid metabolism and 5'-methylthioadenosine in cysteine and methionine metabolism compared with the placebo group. However, THSWD downregulated pelargonic acid, involved in FA metabolism; succinate, involved in the tricarboxylic acid cycle; gluconic acid, gluconolactone, and d-glucose, involved in pentose phosphate pathway; glycerophosphocholine, involved in glycerophospholipid metabolism; 8,9-dihydroxyeicosatrienoic acid (8,9-DiHETrE), l-lysine,  N -acetyl-l-aspartic acid,  N -alpha-acetyl-l-asparagine, hippurate, indoxyl sulfate, and 3-ureidopropionate involved in amino acid metabolism compared with the placebo group. Moreover, succinylcarnitine, pelargonic acid, succinate, d-glucose, gluconic acid, l-lysine,  N -alpha-acetyl-l-asparagine, 5'-methylthioadenosine, indoxyl sulfate, 8,9-DiHETrE, and 3-ureidopropionate were associated with total cholesterol or low-density lipoprotein. Succinylcarnitine, pelargonic acid, gluconolactone,  N -acetyl-l-aspartic acid,  N -alpha-acetyl-l-asparagine, hippurate, and 5'-methylthioadenosine were associated with activated partial thromboplastin time. Our findings indicated that glycerophosphocholine, 8,9-DiHETrE, 5'-methylthioadenosine, hippurate, indoxyl sulfate, and 3-ureidopropionate might constitute the partial material foundation of the ""blood"" in CHD patients treated with THSWD.",2020,"Among the differential metabolites, THSWD upregulated succinylcarnitine in fatty acid metabolism and 5'-methylthioadenosine in cysteine and methionine metabolism compared with the placebo group.","['Eleven CHD patients', 'Coronary Heart Disease Patients With Taohong Siwu Decoction Treatment']","['Taohong Siwu Decoction (THSWD', 'placebo']","[""succinylcarnitine, pelargonic acid, succinate, d-glucose, gluconic acid, l-lysine,  N -alpha-acetyl-l-asparagine, 5'-methylthioadenosine, indoxyl sulfate, 8,9-DiHETrE, and 3-ureidopropionate"", 'total cholesterol or low-density lipoprotein', ""Succinylcarnitine, pelargonic acid, gluconolactone,  N -acetyl-l-aspartic acid,  N -alpha-acetyl-l-asparagine, hippurate, and 5'-methylthioadenosine""]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4039043', 'cui_str': 'Succinylcarnitine'}, {'cui': 'C0070210', 'cui_str': 'Pelargonic acid'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4082271', 'cui_str': 'Gluconic acid'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0048819', 'cui_str': ""5'-methylthioadenosine""}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C4511255', 'cui_str': '3-ureidopropionate'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0061387', 'cui_str': 'Gluconolactone'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0019568', 'cui_str': 'Hippurates'}]",513.0,0.0510597,"Among the differential metabolites, THSWD upregulated succinylcarnitine in fatty acid metabolism and 5'-methylthioadenosine in cysteine and methionine metabolism compared with the placebo group.","[{'ForeName': 'Tianqi', 'Initials': 'T', 'LastName': 'Tao', 'Affiliation': 'Department of Pathophysiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Department of Pathophysiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Pathophysiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Outpatient Department, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pathophysiology, Chinese PLA General Hospital, Beijing, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.00651']
2349,32457640,Post-exercise Endothelium-Dependent Vasodilation Is Dependent on Training Status.,"The effect of training status on post-exercise flow-mediated dilation (FMD) is not well characterized. We tested the hypothesis that the more trained the subjects, the lower the reduction in FMD after an acute bout of aerobic exercise. Forty-seven men (mean ± SD, age: 20.1 ± 1.2 years, body mass: 75.5 ± 5.1 kg, height 178.1 ± 5.4 cm) were divided into five groups with different training characteristics (sedentary, two different groups of active subjects, two different groups of well-trained subjects - runners and weightlifters). Brachial artery FMD (blood pressure cuff placed around the arm distal to the probe with the proximal border adjacent to the medial epicondyle; 5 min at a pressure of 220 mmHg) was assessed before and during 3 min immediately after a bout of cycling exercise at a relative intensity of 170 bpm [(physical work capacity (PWC 170 )]. At baseline, a progressive increase in FMD was observed in the participants with the higher training status, if the training remained moderate. Indeed, FMD was reduced in runners and weightlifters compared to those who were moderately trained. After PWC 170 , FMD did not significantly change in sedentary and highly trained runners, significantly increased in the two groups of active subjects but significantly decreased in highly trained weightlifters. These results showed that endothelium-dependent vasodilation evaluated using brachial FMD is maintained or improved following acute aerobic exercise in moderately trained participants, but not in well-trained participants, especially if they are engaged in resistance training.",2020,"After PWC 170 , FMD did not significantly change in sedentary and highly trained runners, significantly increased in the two groups of active subjects but significantly decreased in highly trained weightlifters.","['Forty-seven men (mean ± SD, age: 20.1 ± 1.2 years, body mass: 75.5 ± 5.1 kg, height 178.1 ± 5.4 cm) were divided into five groups with different training characteristics (sedentary, two different groups of active subjects, two different groups of well-trained subjects - runners and weightlifters']",[],"['Brachial artery FMD (blood pressure cuff placed', 'progressive increase in FMD', 'FMD']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",[],"[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0757865,"After PWC 170 , FMD did not significantly change in sedentary and highly trained runners, significantly increased in the two groups of active subjects but significantly decreased in highly trained weightlifters.","[{'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Kapilevich', 'Affiliation': 'Faculty of Physical Education, National Research Tomsk State University, Tomsk, Russia.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Kologrivova', 'Affiliation': 'Faculty of Physical Education, National Research Tomsk State University, Tomsk, Russia.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Zakharova', 'Affiliation': 'Faculty of Physical Education, National Research Tomsk State University, Tomsk, Russia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mourot', 'Affiliation': 'Division for Physical Education, National Research Tomsk Polytechnic University, Tomsk, Russia.'}]",Frontiers in physiology,['10.3389/fphys.2020.00348']
2350,32457643,Pro12Ala Polymorphism on the PPAR γ 2 Gene and Weight Loss After Aerobic Training: A Randomized Controlled Trial.,"The objective of this study was to verify the influence of the Pro12Ala polymorphism of the PPARγ2 gene in response of a training program on the body composition. Sixty-nine previously inactive men and women (32.8 ± 8.2 years) were genotyped and underwent a 12-week aerobic (running/walking) training program (3-5 sessions, 40 - 60 min per session, and intensity between the aerobic and anaerobic threshold) (experimental group  n  = 53) or were part of the control group ( n  = 16). They were tested for aerobic capacity (ergospirometry), body composition (DXA), abdomen, waist and hip circumferences and nutritional assessment before and 48 h after the experimental protocol. Two-way repeated measures ANOVA test was used to verify possible differences in variables between the experimental vs. control groups or Pro/Pro vs. Pro/Ala groups, and the Chi-squared test was used to verify the distribution of responders and non-responders according to genotype ( p  < 0.05). Frequencies of 75.5% Pro/Pro ( n  = 40) and 24.5% Pro/Ala ( n  = 13) were found, without any occurrence of the recessive homozygote. Body fat reduction was initially confirmed compared to a control group which did not exercise ( n  = 16; 29.1 ± 8.8 years), so that the exercise group obtained a reduction of -1.3 kg vs. -0.3 kg in the control group ( p  = 0.03). When they were divided by genotype, there were significant changes in fat mass (-1.3 ± 2.1 kg;  p  = 0.00), lean mass (0.6 ± 1.5 kg;  p  = 0.02), fat percentage (-1.3 ± 1.6;  p  = 0.00), waist circumference (-2.2 ± 2.9 cm;  p  = 0.00), abdomen circumference (-3.3 ± 3.6 cm;  p  = 0.00) and hip circumference (-2.7 ± 2.7 cm;  p  = 0.00) for Pro/Pro genotypes; and fat mass (-1.1 ± 1.7 kg;  p  = 0.04), fat percentage (-0.9 ± 1.5;  p  = 0.04), abdomen circumference (-3.9 ± 3.5 cm;  p  = 0.00) and hip circumference (-1.8 ± 1.8 cm;  p  = 0.00) for Pro/Ala genotypes, without any group interaction differences. The Chi squared test revealed no differences in the distribution of responders or non-responders according to genotype. It is concluded that an aerobic training program promotes weight loss, but the Pro12Ala polymorphism in the PPARγ2 gene does not influence the variability of aerobic-induced exercise weight loss.",2020,"Body fat reduction was initially confirmed compared to a control group which did not exercise ( n  = 16; 29.1 ± 8.8 years), so that the exercise group obtained a reduction of -1.3 kg vs. -0.3 kg in the control group ( p  = 0.03).",['Sixty-nine previously inactive men and women (32.8 ± 8.2 years'],"['12-week aerobic (running/walking) training program', 'aerobic training program']","['aerobic capacity (ergospirometry), body composition (DXA), abdomen, waist and hip circumferences and nutritional assessment', 'waist circumference', 'hip circumference', 'lean mass', 'weight loss', 'fat mass', 'PPAR γ 2 Gene and Weight Loss', 'Body fat reduction', 'abdomen circumference']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",69.0,0.0193586,"Body fat reduction was initially confirmed compared to a control group which did not exercise ( n  = 16; 29.1 ± 8.8 years), so that the exercise group obtained a reduction of -1.3 kg vs. -0.3 kg in the control group ( p  = 0.03).","[{'ForeName': 'Glêbia Alexa', 'Initials': 'GA', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Darlene Camati', 'Initials': 'DC', 'LastName': 'Persuhn', 'Affiliation': 'Graduate Program in Nutrition Sciences, Federal University of Paraíba (PPGCN/UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Mateus Duarte', 'Initials': 'MD', 'LastName': 'Ribeiro', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Bruno Rafael Virgínio', 'Initials': 'BRV', 'LastName': 'de Sousa', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Klécia de Farias', 'Initials': 'KF', 'LastName': 'Sena', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Antônio Eduardo Monteiro', 'Initials': 'AEM', 'LastName': 'de Almeida', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Modesto-Filho', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, Brazil.'}, {'ForeName': 'Raquel Suelen Brito', 'Initials': 'RSB', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Alexandre Sérgio', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2020.00385']
2351,32457838,Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial.,"Introduction:  Sequential therapy with vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) is effective in some patients with metastatic renal cell carcinoma (mRCC) progressed from or were intolerant to a prior TKIs. Anlotinib is a multi-kinase inhibitor targeting VEGFR1/2/3, PDGFR and FGFR, which has demonstrated efficacy and safety in first-line treatment of mRCC. This study assessed the potential of anloitnib as second-line treatment for patients with mRCC after prior one VEGFR-TKI.  Methods:  This is a single-arm, open-label, phase 2 study. Patients progressed after or were intolerant to sorafenib or sunitinib were enrolled. Anlotinib was administrated orally 12 mg once daily for 14 days every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), safety and quality of life (QoL).  Results:  Forty three patients were enrolled and 42 received anlotinib, of whom 32 progressed after and 10 were intolerant to sorafenib or sunitinib. Median PFS were 14.0 months (95% CI 8.3-20.3) and 8.5 months (95% CI 5.6-16.6) for overall population and patients progressed after a previous VEGFR-TKI, respectively. Median OS was 21.4 months (95% CI 16.0-34.5), confirmed ORR and DCR were 16.7 and 83.3% in overall population. The most common adverse events included diarrhea (47.6%), hypertension (45.2%), hand and foot syndrome (42.9%), and fatigue (40.5%). Grade 3 hematological adverse events occurred in four cases, while no grade 4 hematological adverse events was observed.  Conclusions:  Anlotinib showed promising efficacy as well as favorable safety as second-line treatment for patients with mRCC.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02072044.",2020,"Median OS was 21.4 months (95% CI 16.0-34.5), confirmed ORR and DCR were 16.7 and 83.3% in overall population.","['patients with mRCC after prior one VEGFR-TKI', 'patients with metastatic renal cell carcinoma (mRCC) progressed from or were intolerant to a prior TKIs', 'Patients progressed after or were intolerant to sorafenib or sunitinib were enrolled', 'Patients With Metastatic Renal Cell Carcinoma', 'Results:  Forty three patients were enrolled and 42 received anlotinib, of whom 32 progressed after and 10 were intolerant to', 'patients with mRCC']","['One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor', 'sorafenib or sunitinib', 'vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs']","['diarrhea', 'Grade 3 hematological adverse events', 'Median PFS', 'Median OS', 'ORR and DCR', 'fatigue', 'overall survival (OS), objective response rate (ORR), safety and quality of life (QoL', 'hematological adverse events', 'progression-free survival (PFS', 'hypertension', 'hand and foot syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}]","[{'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia'}]",43.0,0.127311,"Median OS was 21.4 months (95% CI 16.0-34.5), confirmed ORR and DCR were 16.7 and 83.3% in overall population.","[{'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Shou', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Hanzhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Oncology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Urology and Oncology, Chongqing University Cancer Hospital, Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Xiubao', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': ""Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer/Key Laboratory of Cancer Prevention and Therapy, Tianjin/Tianjin's Clinical Research Center for Cancer, Tianjin, China.""}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xianzhong', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Urinary Surgery, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Urology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Center, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Jinwan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.00664']
2352,32457854,Minimally Invasive Surfactant Administration for the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter Randomized Study in China.,"Background/Aims:  Nasal continuous positive airway pressure (nCPAP) was recommended as the initial respiratory support for spontaneous breathing in infants with very low birth weight and neonatal respiratory distress syndrome (NRDS). Less invasive surfactant administration (LISA) and minimally invasive surfactant therapy (MIST) have been reported to reduce the incidence of bronchopulmonary dysplasia (BPD). This study aimed to explore the applicability of minimally invasive surfactant administration (MISA) in China.  Materials and Methods : MISA was a randomized controlled study conducted at eight level III neonatal intensive care units (NICUs) in China. Spontaneously breathing infants born at 25+0 to 31+6 weeks' gestation who progressively developed respiratory distress during the first 6 h after birth were randomly assigned to receive MISA or endotracheal intubation surfactant administration (EISA). The primary outcome was the difference in the morbidity of BPD between two groups of infants with MISA and EISA at 36 weeks corrected gestational age.  Results : Demographic and clinical characteristics of the 151 infants in the MISA group were similar to the 147 infants in the EISA group. The comparison showed no clear benefits in the MISA group in the incidence of BPD, while infants from the EISA group had higher rates of patent ductus arteriosus (PDA) (60.5 vs. 41.1%,  p  = 0.001). The duration of surfactant infusion and the total time of surfactant administration in the MISA group were significantly longer than in the EISA group. A slightly increased heart rate was noted 1 h post surfactant administration in the EISA group. In subgroup analysis, the comparison of 51 smaller (<30 weeks) preterm infants, named MISAs ( n  = 31) and EISAs ( n  = 20), showed a significant reduction of BPD (29.0 vs. 70.0%,  p  = 0.004) and PDA (29.0 vs. 65.0%,  p  = 0.011). In the subgroup analysis of blood gas, arterial oxygen saturation (SaO 2 ) value at 1 and 12 h and partial pressure of arterial oxygen (PaO 2 ) at 12 h were all higher in the EISA group compared to the MISA group.  Conclusion : MISA had no clear benefit on the incidence of BPD, but it was related to a reduction in PDA. It is an appropriate therapy for spontaneous breathing in infants with extremely low birth weight and NRDS.",2020,Demographic and clinical characteristics of the 151 infants in the MISA group were similar to the 147 infants in the EISA group.,"['China', 'infants with extremely low birth weight and NRDS', 'infants with very low birth weight and neonatal respiratory distress syndrome (NRDS', 'eight level III neonatal intensive care units (NICUs) in China', ""Spontaneously breathing infants born at 25+0 to 31+6 weeks' gestation who progressively developed respiratory distress during the first 6 h after birth"", 'Neonatal Respiratory Distress Syndrome', '151 infants in the MISA group were similar to the 147 infants in the EISA group']","['Materials and Methods ', 'minimally invasive surfactant administration (MISA', 'MISA or endotracheal intubation surfactant administration (EISA', 'Minimally Invasive Surfactant Administration', 'EISA', 'invasive surfactant administration (LISA) and minimally invasive surfactant therapy (MIST', 'Nasal continuous positive airway pressure (nCPAP', 'MISA']","['incidence of BPD', 'morbidity of BPD', 'BPD', 'heart rate', 'PDA', 'duration of surfactant infusion and the total time of surfactant administration', 'blood gas, arterial oxygen saturation (SaO 2 ) value at 1 and 12 h and partial pressure of arterial oxygen (PaO 2 ', 'rates of patent ductus arteriosus (PDA']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",151.0,0.0932987,Demographic and clinical characteristics of the 151 infants in the MISA group were similar to the 147 infants in the EISA group.,"[{'ForeName': 'Tongyan', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Huiqiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xinjian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Hebei PetroChina Central Hospital, Langfang, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Hebei PetroChina Central Hospital, Langfang, China.'}, {'ForeName': 'Mingtao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Hebei PetroChina Central Hospital, Langfang, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Bethune International Peace Hospital, Shijiazhuang, China.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': 'Department of Neonatology, Bethune International Peace Hospital, Shijiazhuang, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjing, China.'}, {'ForeName': 'Xiuying', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjing, China.'}, {'ForeName': 'Wanxian', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00182']
2353,32458035,Simultaneous single-stage versus two-staged bilateral total knee arthroplasty: a prospective comparative study.,"PURPOSE


The study aims to prospectively compare peri-operative morbidity and mortality of simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA) performed within 12 months of the first surgery. We hypothesized that SS BLTKA is as safe as TS BLTKA.
METHODS


Patients with a minimum follow-up of 12 months were included in this study. Oxford knee score and quality of life index SF12 was compared between the 2 groups at six weeks and six month follow-up.
RESULTS


SS BLTKA included 250 patients and TS BLTKA included 210 patients. The minimum time interval between two operations was three weeks (mean 1.6 months, range 3 weeks-12 months). There was no significant difference between the 2 groups in peri-operative mortality, surgical site infection, major peri-operative complications. There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up. There was no difference in the range of knee flexion between the 2 groups at six months. Post-operative haemoglobin drop was significantly more in SS BLTKA patients and consequently, blood transfusion requirement was significantly higher in SS BLTKA. There was a significantly higher length of hospital stay and duration of surgery in TS BLTKA group.
CONCLUSION


There does not appear to be a difference in complication rates between the 2 groups. SS BLTKA seems to be a logical choice if both knees have severe osteoarthritis. Patients with severe cardiopulmonary compromise were excluded, and a unilateral procedure may be preferred in them.",2020,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"['Patients with severe cardiopulmonary compromise', 'Patients with a minimum follow-up of 12\xa0months', '250 patients and TS BLTKA included 210 patients']","['Simultaneous single-stage versus two-staged bilateral total knee arthroplasty', 'simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA']","['blood transfusion requirement', 'length of hospital stay and duration of surgery', 'complication rates', 'peri-operative mortality, surgical site infection, major peri-operative complications', 'minimum time interval', 'Oxford knee score and quality of life index SF12', 'range of knee flexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0576095', 'cui_str': 'Range of knee flexion'}]",250.0,0.0426341,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda, Punjab, 151001, India. goyal.tarun@gmail.com.'}, {'ForeName': 'Md Quamar', 'Initials': 'MQ', 'LastName': 'Azam', 'Affiliation': 'Department of Trauma Surgery, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}]",International orthopaedics,['10.1007/s00264-020-04642-6']
2354,32458074,Effect of interdental brush design on plaque during nonsurgical periodontal therapy.,"OBJECTIVE


The aim of this randomized controlled trial was to evaluate the interproximal cleaning efficacy of waist-shaped compared with straight soft interdental brushes in patients undergoing nonsurgical periodontal therapy.
MATERIALS AND METHODS


Ten patients diagnosed with periodontitis stage II or III were scheduled for nonsurgical periodontal therapy. Baseline plaque control record (PCR), modified approximal plaque index (API), papillary bleeding index (PBI), probing pocket depth (PPD), and bleeding on probing (BOP) were evaluated. Four interdental spaces of equal sizes were determined, and baseline plaque indices (PI) were assessed on eight surfaces of the respective adjacent teeth, resulting in 640 measuring positions. Interdental brushes with a straight or waist-shaped design were randomly allocated to the right or left side, and patients received oral hygiene instructions. Follow-up measurements including PCR, API, PBI, and site-specific PI were performed during initial nonsurgical periodontal therapy sessions and reevaluation which was undertaken 8 weeks afterwards.
RESULTS


PCR, API, and PBI decreased significantly compared with baseline at each time point (p < 0.001). PPD (waist-shaped, baseline 4 mm (range, 2-9 mm) vs. reevaluation 3 mm (range, 1-6 mm); p < 0.001; straight, baseline 4 mm (range, 2-10) vs. reevaluation 3 mm (range, 1-6) mm; p < 0.001) and BOP (p = 0.008) showed significant reduction in both groups. Sub-analysis of site-specific areas including line angles and interproximal areas revealed no significant reduction of plaque during the observation period between both brush designs. No difference between straight and waist-shaped brushes regarding PPD or BOP decrease was found.
CONCLUSION


The efficacy of both interdental brush designs concerning plaque control in patients undergoing nonsurgical periodontal therapy was similar.
CLINICAL RELEVANCE


The use of interdental brushes is essential for biofilm removal in patients during initial periodontal therapy, regardless of brush design.
CLINICAL TRIAL REGISTRATION


ISRCTNregistry (#ISRCTN24498365), http://www.isrctn.com/ISRCTN24498365.",2020,Sub-analysis of site-specific areas including line angles and interproximal areas revealed no significant reduction of plaque during the observation period between both brush designs.,"['patients undergoing nonsurgical periodontal therapy was similar', 'patients undergoing nonsurgical periodontal therapy', 'Ten patients diagnosed with periodontitis stage II or III were scheduled for']","['nonsurgical periodontal therapy', 'oral hygiene instructions', 'straight soft interdental brushes']","['PCR, API, PBI, and site-specific PI', 'Baseline plaque control record (PCR), modified approximal plaque index (API), papillary bleeding index (PBI), probing pocket depth (PPD), and bleeding on probing (BOP', 'BOP', 'PCR, API, and PBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449604', 'cui_str': 'Specific site'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",10.0,0.105467,Sub-analysis of site-specific areas including line angles and interproximal areas revealed no significant reduction of plaque during the observation period between both brush designs.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wehner', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Husejnagic', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Laky', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Rausch-Fan', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Moritz', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Haririan', 'Affiliation': 'Department of Periodontology, Medical Faculty, Sigmund Freud University Vienna, Freudplatz 3, 1020, Vienna, Austria. hady.haririan@med.sfu.ac.at.'}]",Clinical oral investigations,['10.1007/s00784-020-03337-x']
2355,32458107,A web-based adapted physical activity program (e-APA) versus health education program (e-HE) in patients with schizophrenia and healthy volunteers: study protocol for a randomized controlled trial (PEPSY V@Si).,"Patients with schizophrenia (SZ) have a high level of cardiovascular morbidity and some clinical symptoms of illness remain resistant to pharmacological approaches. A large number of studies support the effectiveness of physical activity (PA) in SZ. The aims of this trial is to assess the effects of a remote, web-based adapted PA program (e-APA) compared to a health education program (e-HE) on brain plasticity in SZ and healthy volunteers (HV) and on psychiatric, neurocognitive, circadian and physical variables. The study is an interventional, multicenter, randomized open-label trial. Forty-two SZ will be randomized to either the active group (e-APA, N = 21) or nonactive group (e-HE, N = 21), and 21 HV will be matched to SZ according to age, gender, and level of PA in both e-APA and e-HE groups. Interventions will consist of 32 sessions (2 × 60 min/week, for 16 weeks) via supervised home-based videoconferencing. Cerebral magnetic resonance imaging, psychiatric symptoms, neurocognitive and circadian rhythms assessments as well as physical tests and biological analyses will be assessed at baseline and 16 weeks after the intervention. To our knowledge, this is the first study aiming to evaluate the efficacy of APA delivered by supervised home-based videoconferencing in SZ. Moreover, using multimodal MRI, this study could clarify the pathophysiological mechanisms underlying the efficacy of APA. Finally, this innovative approach might also increase participation in long-term PA since PA-based programs are known to have low adherence and early dropout. Trial registration: ClinicalTrials.gov identifier: NCT03261817. Registered on 16 August 2017.",2020,"Interventions will consist of 32 sessions (2 × 60 min/week, for 16 weeks) via supervised home-based videoconferencing.","['Patients with schizophrenia (SZ', 'patients with schizophrenia and healthy volunteers', 'SZ and healthy volunteers (HV']","['A web-based adapted physical activity program (e-APA) versus health education program (e-HE', 'APA', 'remote, web-based adapted PA program (e-APA', 'health education program (e-HE']","['brain plasticity', 'Cerebral magnetic resonance imaging, psychiatric symptoms, neurocognitive and circadian rhythms assessments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0113523', 'cui_str': ""diadenosine 5',5''''-P1,P6-hexaphosphate""}]","[{'cui': 'C5200806', 'cui_str': 'Brain Plasticity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",42.0,0.0869635,"Interventions will consist of 32 sessions (2 × 60 min/week, for 16 weeks) via supervised home-based videoconferencing.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Tréhout', 'Affiliation': 'CHU de Caen Normandie, Service de Psychiatrie, Centre Esquirol, 14000, Caen, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Leroux', 'Affiliation': 'Normandie Univ, UNICAEN, ISTS EA 7466, GIP CYCERON, 14000, Caen, France.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': 'MOOVEN, 14000, Caen, France.'}, {'ForeName': 'Solenne', 'Initials': 'S', 'LastName': 'Jego', 'Affiliation': 'Normandie Univ, UNICAEN, ISTS EA 7466, GIP CYCERON, 14000, Caen, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Leconte', 'Affiliation': 'Normandie Univ, UNICAEN/INSERM, UMR 1075, COMETE, PFRS, 14000, Caen, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Reboursière', 'Affiliation': 'CHU de Caen Normandie, Service de Médecine du Sport, 14000, Caen, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'CHU de Caen Normandie, Unité de Biostatistiques et Recherche Clinique, 14000, Caen, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Chapon', 'Affiliation': 'BodyCap, 14200, Hérouville Saint-Clair, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Herbinet', 'Affiliation': 'MOOVEN, 34270, Saint-Mathieu-de-Treviers, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Quarck', 'Affiliation': 'Normandie Univ, UNICAEN/INSERM, UMR 1075, COMETE, PFRS, 14000, Caen, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Dollfus', 'Affiliation': 'CHU de Caen Normandie, Service de Psychiatrie, Centre Esquirol, 14000, Caen, France. dollfus-s@chu-caen.fr.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01140-z']
2356,32458114,"Letter referencing ""Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting in glioma patients receiving adjuvant temozolomide"".",,2020,,['glioma patients receiving adjuvant temozolomide'],"['ondansetron', '5-day aprepitant plus ondansetron']",['nausea-vomiting'],"[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0160283,,"[{'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Morio', 'Affiliation': 'Department of Pharmacy, Kobe University Hospital, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan. kayoko.morio0826@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Internal medicine, Iwami Hospital, 1029-2 Uradome Iwami, Tottori, 681-0003, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Nephrology and Dialysis, Kyoritsu Hospital, Chuo-cho 16-5, Kawanishi, 666-0016, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05537-3']
2357,32458136,Arterial Hypertension in Children.,"Pharmacological treatment of arterial hypertension in children is mainly based on individual experience, but there is evidence that blocking the angiotensin system reduces systolic and diastolic blood when compared to placebo, and these drugs are safe to use for a short duration, also in children under 6 years of age. Blocking the angiotensin system either by angiotensin-converting enzyme inhibitors or by antagonizing the angiotensin 1 receptor is effective, but did not display a consistent dose-response relationship with escalating doses, but the effective doses are known. Calcium channel antagonists are effective antihypertensives in children, but the evidence is limited. Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo. They act in combination to antagonize reflex tachycardia induced by vasodilators. The most commonly used antihypertensive agents are safe to use in short-term studies.",2020,"Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo.","['children under 6\xa0years of age', 'Arterial Hypertension in Children']","['Calcium channel antagonists', 'placebo']","['diastolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0454771,"Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rascher', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander - University Erlangen-Nürnberg, Erlangen, Germany. wolfgang.rascher@uk-erlangen.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paech', 'Affiliation': 'Department for Pediatric Cardiology, University of Leipzig - Heart Center, Leipzig, Germany.'}]",Handbook of experimental pharmacology,['10.1007/164_2020_359']
2358,32458282,EEG Theta/Beta Ratio Neurofeedback Training in Healthy Females.,A growing number of studies suggest that EEG theta/beta ratio (TBR) is inversely related to executive cognitive control. Neurofeedback training aimed at reducing TBR (TBR NFT) might provide a tool to study causality in this relation and might enhance human performance. To investigate whether TBR NFT reduces TBR in healthy participants. Twelve healthy female participants were assigned (single blind) to one of three groups. Groups differed on baseline durations and one group received only sham NFT. TBR NFT consisted of eight or fourteen 25-min sessions. No evidence was found that TBR NFT had any effect on TBR. The current TBR NFT protocol is possibly ineffective. This is in line with a previous study with a different protocol.,2020,No evidence was found that TBR NFT had any effect on TBR.,"['healthy participants', 'Healthy Females', 'Twelve healthy female participants']","['sham NFT', 'Neurofeedback training aimed at reducing TBR (TBR NFT', 'TBR NFT']","['TBR', 'EEG Theta/Beta Ratio Neurofeedback Training', 'EEG theta/beta ratio (TBR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0085400', 'cui_str': 'Neurofibrillary degeneration'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",12.0,0.0266986,No evidence was found that TBR NFT had any effect on TBR.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'van Son', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands. dana.vanson@yale.edu.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van der Does', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Guido P H', 'Initials': 'GPH', 'LastName': 'Band', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Putman', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09472-1']
2359,32458286,A randomized controlled trial comparing right and left lateral decubitus starting position on outcomes in colonoscopy.,"BACKGROUND


Patient positioning in colonoscopy has been proposed as a simple and inexpensive technique to increase luminal distention and improve navigation through the large bowel. We sought to determine if the right lateral (RL) starting position compared to the standard left lateral (LL) starting position could improve outcomes in colonoscopy.
METHODS


We conducted a randomized controlled trial of 185 patients who were undergoing an elective colonoscopy. Patients were randomized to either a right lateral decubitus starting position or a left lateral decubitus starting position and the primary outcome measure was cecal intubation time. Secondary outcome measures included cecal intubation rate, patient discomfort, and sedation dosage. All colonoscopists who had successfully completed a colonoscopy skills improvement course were included in the trial. A sample size was calculated prior to the start of the study and outcomes were analyzed using univariate and multiple regression analyses.
RESULTS


A total of 94 patients were randomized to RL starting position and 91 patients were randomized to LL starting position. No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s) (p = 0.354). Variables associated with prolonged cecal intubation time included female gender, General Surgery specialty, less than 5 years of endoscopist experience, a high patient discomfort score, amount of water used, and number of position changes required to reach the cecum. There was no difference in any of the secondary outcome measures aside from the amount of midazolam used, with more midazolam used for patients starting in the right lateral decubitus position.
CONCLUSION


This study failed to show an association between cecal intubation time and patient position comparing right and left lateral starting position.",2020,"No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s)","['94 patients', '185 patients who were undergoing an elective colonoscopy', 'All colonoscopists who had successfully completed a colonoscopy skills improvement course were included in the trial']","['right and left lateral decubitus starting position', 'right lateral decubitus starting position or a left lateral decubitus starting position', 'midazolam']","['time to cecal intubation', 'prolonged cecal intubation time included female gender, General Surgery specialty, less than 5\xa0years of endoscopist experience, a high patient discomfort score, amount of water used, and number of position changes required to reach the cecum', 'cecal intubation time', 'cecal intubation rate, patient discomfort, and sedation dosage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444793', 'cui_str': 'Position change'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",185.0,0.163214,"No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s)","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Greene', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Borgoankar', 'Affiliation': ""Department of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Hodgkinson', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Chantae', 'Initials': 'C', 'LastName': 'Garland', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bacque', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pace', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada. dpace@mun.ca.""}]",Surgical endoscopy,['10.1007/s00464-020-07661-x']
2360,32458301,The Disaggregated Repeated Measures Design: A Novel Approach to Assess Sexual Risk Behaviors.,"Although numerous studies have examined sexual and substance use behaviors that put people at risk for sexually transmitted infections including HIV, most focus on an overall measure of aggregate risk or a few simple and particular subtypes of sexual acts assessed in separate analyses. In this article, we introduce a more sensitive approach to assess how the relative characteristics of sex acts may determine the level of risk in which an individual chooses to engage. Project AWARE, a randomized clinical trial conducted among 5012 patients in nine STD clinics across the U.S., is used to illustrate the approach. Our study was guided by two aims: (1) describe a new approach to examine the count of sexual acts using a disaggregated repeated measures design and (2) show how this new approach can be used to evaluate interactions among different categories of sexual risk behaviors and other predictors of interest (such as gender/sexual orientation). Profiles of different subtypes of sexual acts in the past 6 months were assessed. Potential interactions of the characteristics associated with each subtype which resulted in up to 48 distinct subtypes of sexual risk behaviors-sex with a primary/non-primary partner; partner's HIV status; vaginal/anal sex; condom use; and substance use before or during sex act-can be examined. Specifically, we chose condom use and primary and non-primary status of partner as an application in this paper to illustrate our method. There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001). In addition, there were significant differences for the count of sexual risk behaviors among women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM) for sex acts with and without condom use, primary and non-primary partner, and their interaction (ps = .03, < .0001, and .001, respectively). This approach extends our understanding of how people make choices among sexual behaviors and may be useful in future research on disaggregated characteristics of sex acts.",2020,"There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001).","[""48 distinct subtypes of sexual risk behaviors-sex with a primary/non-primary partner; partner's HIV status; vaginal/anal sex"", '5012 patients in nine STD clinics across the U.S', 'women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM']",[],"['Sexual Risk Behaviors', 'condomless sex acts', 'sexual risk behaviors']","[{'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",5012.0,0.0334994,"There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA. panyue@med.miami.edu.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Gooden', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Alejandro Max Antonio', 'Initials': 'AMA', 'LastName': 'Mantero', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01582-0']
2361,32458362,Biliopancreatic Limb Length in One Anastomosis Gastric Bypass: Which Is the Best?,"BACKGROUND


The use of one anastomosis gastric bypass (OAGB) is rapidly spreading. Concerns about biliary reflux and malabsorption with consequent nutritional deficits exist, so studies on biliopancreatic limb (BPL) adequate length in OAGB are required to balance excess weight loss in percentage (% EWL), resolution of comorbidities, and nutritional deficit. The purpose was to evaluate, at 2 years after OAGB, the effects of BPL length on weight loss, resolution of comorbidity, and nutritional deficiencies in patients.
METHODS


From January 2015 to January 2017, 180 patients were collected into three groups based BPL length: group A, 150 cm; group B, 180 cm; and group C, 200 cm. Aims were to compare %EWL, co-morbidity resolution rates, nutritional parameters, and morbidity/mortality in the three groups.
RESULTS


The total number of patients was 180: 60 for each group. One hundred seventy-two (95%) patients attended the 1-year follow-up (group A = 58; group B = 58, group C = 56). One hundred fifty-seven (87%) patients attended the 2-year follow-up (group A = 52 (87%); group B = 53 (88%); group C = 52 (87%)). There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups. About vitamin deficiency, differences were not statistically significant. Iron and ferritin deficiency rate were statistically significant only between A and C groups.
CONCLUSIONS


According to our evidence, standardization of BPL length shorter than 200 cm is suggested, potentially minimizing malnutrition-related outcomes. Our study seems to show that a BPL of 150-180 cm is safe and effective in terms of EWL and comorbidity improvement with low malnutrition effects even in BMI > 50.",2020,"There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups.","['From January 2015 to January 2017, 180 patients', 'One hundred seventy-two (95%) patients attended the 1-year follow-up (group A\u2009=\u200958; group B\u2009=\u200958, group C\u2009=\u200956', 'One Anastomosis Gastric Bypass', 'patients']",['anastomosis gastric bypass (OAGB'],"['weight loss, resolution of comorbidity, and nutritional deficiencies', 'Biliopancreatic Limb Length', 'Iron and ferritin deficiency rate', 'EWL, %TWL, T2DM, and hypertension resolution rates', 'EWL, co-morbidity resolution rates, nutritional parameters, and morbidity/mortality']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",180.0,0.0341174,"There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy. Francesco_pizza@libero.it.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': ""D'Antonio"", 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""Dell'Isola"", 'Affiliation': 'Department of Infectious Diseases, AORN ""Dei Colli"", Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marvaso', 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04687-x']
2362,32458391,Temporal Deployment of Attention by Mental Training: an fMRI Study.,"In this study, we employed a visuo-motor imagery task of alertness as a mental training to examine temporal processing of motor responses within healthy young adults. Participants were divided into two groups (group 1; n = 20 who performed the mental training before the real physical task and a control group who performed the physical task without mental training). We vary the time interval between the imperative stimulus and the preceding one (fore-period) in which temporal preparation and arousal increase briefly. Our behavioural results provide clear evidence that mental training reinforces both temporal preparation and arousal, by shortening reaction time (RT), especially for the shortest fore-periods (FP) within exogenous ""FP 250 ms"" (p = 0.008) and endogenous alertness ""FP 650 ms"" (p = 0.001). We investigated how the brain controls such small temporal changes. We focus our neural hypothesis on three brain regions: anterior insula, dorsolateral prefrontal cortex, and anterior cingulate cortex and three putative circuits: one top-down (from dorsolateral prefrontal cortex to anterior cingulate cortex) and two bottom-up (from anterior insula to dorsolateral prefrontal cortex and anterior cingulate cortex). In fMRI, effective connectivity is strengthened during exogenous alertness between anterior insula and dorsolateral prefrontal cortex (p = 0.001), between anterior insula and cingulate cortex (p = 0.01), and during endogenous alertness between dorsolateral prefrontal cortex and anterior cingulate cortex (p = 0.05). We suggest that attentional reinforcement induced by an intensive and short session of mental training induces a temporal deployment of attention and allow optimizing the time pressure by maintaining a high state of arousal and ameliorating temporal preparation.",2020,"In fMRI, effective connectivity is strengthened during exogenous alertness between anterior insula and dorsolateral prefrontal cortex (p = 0.001), between anterior insula and cingulate cortex (p = 0.01), and during endogenous alertness between dorsolateral prefrontal cortex and anterior cingulate cortex (p = 0.05).",['healthy young adults'],"['Temporal Deployment of Attention by Mental Training', 'mental training before the real physical task and a control group who performed the physical task without mental training', 'visuo-motor imagery task of alertness as a mental training']","['anterior insula and cingulate cortex', 'endogenous alertness between dorsolateral prefrontal cortex and anterior cingulate cortex', 'shortening reaction time (RT']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0136049,"In fMRI, effective connectivity is strengthened during exogenous alertness between anterior insula and dorsolateral prefrontal cortex (p = 0.001), between anterior insula and cingulate cortex (p = 0.01), and during endogenous alertness between dorsolateral prefrontal cortex and anterior cingulate cortex (p = 0.05).","[{'ForeName': 'Souhir', 'Initials': 'S', 'LastName': 'Daly', 'Affiliation': 'LINP2 (Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology), Université Paris Nanterre, 200 Avenue de la république, 92000, Nanterre, France. souhir.daly91@gmail.com.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Thai', 'Affiliation': 'Clinical Research & Imaging Centre (CRICBristol), Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Belkhiria', 'Affiliation': 'LINP2 (Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology), Université Paris Nanterre, 200 Avenue de la république, 92000, Nanterre, France.'}, {'ForeName': 'Chistelle', 'Initials': 'C', 'LastName': 'Langley', 'Affiliation': 'Clinical Research & Imaging Centre (CRICBristol), Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alain Le', 'Initials': 'AL', 'LastName': 'Blanche', 'Affiliation': 'LINP2 (Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology), Université Paris Nanterre, 200 Avenue de la république, 92000, Nanterre, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'LINP2 (Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology), Université Paris Nanterre, 200 Avenue de la république, 92000, Nanterre, France.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00795-4']
2363,32458393,Correction to: Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"The original version of this article, unfortunately, contained an error. The given names and family names of the authors were interchanged and are now presented correctly. The original article has been corrected.].",2020,"The original version of this article, unfortunately, contained an error.",['pilonidal disease'],['Conservative Sinusectomy vs. excision and primary off-midline closure'],[],"[{'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.0503036,"The original version of this article, unfortunately, contained an error.","[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo', 'Initials': 'A', 'LastName': 'Ferrario di Tor Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland. dimitri.christoforidis@eoc.ch.'}]",International journal of colorectal disease,['10.1007/s00384-020-03620-z']
2364,32458450,"Effect of Oro-pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Gastrin, Motilin, Secretin, and Cholecystokinin Hormones in Preterm Infants: A Pilot Crossover Study.","BACKGROUND


Oro-pharyngeal administration of milk prior to gavage feeding improve feeding tolerance in preterm infants.
OBJECTIVES


To study the effect of Oro-Pharyngeal Administration of Mother's Milk (OPAMM) prior to gavage feeding on the levels of gastrin, motilin, secretin, and cholecystokinin hormones.
METHODS


Preterm infants (< 32 weeks gestation) were randomized at a corrected gestational age of 33 to 34 weeks, in a cross over design, to receive one of two protocols; 24 hours of OPAMM practice (applying 0.2 mL of mother's milk prior to each gavage feeding) followed by 24 hours of regular gavage feeding practice in the first protocol or vice versa in the second protocol. The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices.
RESULTS


The data of 40 preterm infants (20 in each protocol) were analyzed. OPAMM was associated with a significant increase in the levels of motilin (median 233; inter-quartile range [IQR] 196 - 296 versus median 196 IQR: 128 - 233, p < 0.01) , secretin (median 401; IQR: 353 - 458 versus median 370; IQR: 331 - 407, p = 0.04), and cholecystokinin (median 21.4; IQR: 16 - 27.1 versus median 14.9; IQR: 11 - 20.5, p <0.01) but not gastrin (median 202; IQR: 125 - 238 versus median 175; IQR: 128 - 227, p = 0.7) compared to regular gavage feeding practice.
CONCLUSION


Oro-pharyngeal stimulation by OPAMM prior to gavage feeding significantly increased motilin hormone and possibly increase secretin and cholecystokinin hormones. This article is protected by copyright. All rights reserved.",2020,"The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices.
","['preterm infants', 'Preterm Infants', ""Mother's Milk"", '40 preterm infants (20 in each protocol', 'Preterm infants (< 32 weeks gestation']","[""Oro-Pharyngeal Administration of Mother's Milk (OPAMM"", ""OPAMM practice (applying 0.2 mL of mother's milk prior to each gavage feeding""]","['Gastrin, Motilin, Secretin, and Cholecystokinin Hormones', 'levels of gastrin, motilin, secretin, and cholecystokinin hormones', 'levels of motilin', 'OPAMM', 'motilin hormone', 'secretin and cholecystokinin hormones']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}]","[{'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0026594', 'cui_str': 'Motilin'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0321978,"The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices.
","[{'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Eid', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Mansoura.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Elzehery', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, University of Mansoura.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Al-Harrass', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, University of Mansoura.'}, {'ForeName': 'Basma', 'Initials': 'B', 'LastName': 'Shouman', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Nasef', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1935']
2365,32458473,Effectiveness of nurse-led group CBT for hot flushes and night sweats in women with breast cancer: results of the MENOS4 randomised controlled trial.,"OBJECTIVE


Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT delivered by breast care nurses (BCNs) can reduce the impact of HFNS.
METHODS


We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks post randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life.
RESULTS


Between 2017-2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9 to 3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5 to 5.5) reduction in the UC arm (adjusted mean difference - 1.96, CI -3.68 to -0.23, P = 0.039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly.
CONCLUSION


Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.",2020,Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.,"['130 participants were recruited (CBT:63, control:67', 'Between 2017-2018', 'recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial', 'women with breast cancer']","['nurse-led group CBT', 'Group CBT or usual care (UC', 'CBT delivered by breast care nurses (BCNs', 'Cognitive behavioural therapy (CBT']","['frequency of HFNS, sleep, anxiety and depression all improved significantly', 'mean HFNS problem rating score', 'HFNS problem rating', 'sleep, depression, anxiety and quality of life']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",130.0,0.118211,Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fenlon', 'Affiliation': 'Dept Nursing, College of Human and Health Sciences, Swansea University, Singleton Campus, Swansea.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Nuttall', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ellis', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Turner', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Fields', 'Affiliation': 'Poole Hospital NHS Trust, Poole.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, MP131 Southampton General Hospital, Tremona Road, Southampton.'}, {'ForeName': 'Myra S', 'Initials': 'MS', 'LastName': 'Hunter', 'Affiliation': ""Dept Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London.""}]",Psycho-oncology,['10.1002/pon.5432']
2366,32458506,"A randomised trial comparing conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels between semen collection at home and at the clinic.","The aim of the randomised trial was to compare conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels between semen samples collected at home and at the clinic. We recruited 110 men with a history of infertility for at least 1 year from the outpatient andrology clinic. Each man collected two semen samples, one at home and one at the clinic. Men were randomly assigned into the home first (n = 55) or clinic first (n = 55) groups. The primary outcome was sperm concentration. There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01). Consistent results were obtained when comparing home-collected and clinic-collected samples within individuals. Men can be offered the option to collect semen samples at home for examination or assisted reproduction without compromising semen quality, especially for those with difficulty in producing semen samples at the clinic.",2020,"There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01).",['110 men with a history of infertility for at least 1\xa0year from the outpatient andrology clinic'],[],"['sperm DNA fragmentation levels and satisfaction levels', 'sperm concentration, sperm DNA fragmentation levels', 'satisfaction levels', 'sperm concentration', 'conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",110.0,0.0368193,"There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Yong-Gang', 'Initials': 'YG', 'LastName': 'Duan', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'William S B', 'Initials': 'WSB', 'LastName': 'Yeung', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ernest H Y', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}]",Andrologia,['10.1111/and.13628']
2367,32458554,Cognitive behavioural therapy for help-seeking adolescents and young adults with at-risk-mental state: Effects on subclinical positive symptoms.,"AIM


Cognitive behavioural therapy (CBT) is effective for at-risk-mental state (ARMS) in reducing/delaying transition to psychosis. However, previous systematic reviews pointed out the small number of trials as a limitation and suggested that additional outcomes should be evaluated, not only prevention of first psychosis episode. No study assessed the CBT effects on subclinical psychotic symptoms. The present study investigated the effects of CBT on the transition risk (primary outcome), and on overall remission from ARMS and severity of subclinical symptoms, that is, unusual content of thought, non-bizarre ideas, perceptual abnormalities, disorganized speech (secondary outcome).
METHODS


CBT consisted of 30 individual weekly sessions over 7 months. Fifty-eight participants with ARMS detected by the Comprehensive Assessment of At-Risk-Mental States were randomized to CBT or control condition.
RESULTS


Respectively in the CBT and control groups, 1 (3.40%) and 5 (26.31%) participants at post-treatment and 3 (10.30%) and 8 (42.10%) at follow-up made transition with a difference between the two groups, despite at borderline significance. At post-treatment and follow-up, respectively, the number of participants recovered from ARMS was significantly higher in CBT (76.92% and 61.53%) than in control (10.52% and 15.80%). Participants in the control group reported lower reductions on all the subclinical symptoms over time as compared with those in CBT.
CONCLUSIONS


This is the first study assessing CBT on subclinical positive symptoms in ARMS. CBT seems to be a tailored approach able to produce short- and long-term benefits on this outcome.",2020,"At post-treatment and follow-up, respectively, the number of participants recovered from ARMS was significantly higher in CBT (76.92% and 61.53%) than in control (10.52% and 15.80%).","['Fifty-eight participants with ARMS detected by the Comprehensive Assessment of At-Risk-Mental States', 'help-seeking adolescents and young adults with at-risk-mental state']","['Cognitive behavioural therapy', 'CBT', 'Cognitive behavioural therapy (CBT']","['subclinical symptoms', 'CBT', 'CBT effects on subclinical psychotic symptoms']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C4305073', 'cui_str': 'CAARMS - Comprehensive Assessment of At-Risk Mental States'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",58.0,0.0822079,"At post-treatment and follow-up, respectively, the number of participants recovered from ARMS was significantly higher in CBT (76.92% and 61.53%) than in control (10.52% and 15.80%).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pozza', 'Affiliation': 'Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Domenichetti', 'Affiliation': 'Adult Mental Health Unit, Azienda USL Toscana Centro, Borgo San Lorenzo (Florence), Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Dèttore', 'Affiliation': 'Department of Health Sciences, University of Florence, Florence, Italy.'}]",Early intervention in psychiatry,['10.1111/eip.12974']
2368,32458557,Partial sleep deprivation after an acute exercise session does not augment hepcidin levels the following day.,"The purpose of the present study was to determine the effects of partial sleep deprivation (PSD) after an exercise session in the evening on the endurance exercise-induced hepcidin response the following morning. Ten recreationally trained males participated under two different conditions. Each condition consisted of 2 consecutive days of training (days 1 and 2). On day 1, participants ran for 60 min at 75% of maximal oxygen uptake (  V   ˙    O 2max  ) followed by 100 drop jumps. Sleep duration at night was manipulated, with a normal length of sleep (CON condition, 23:00-07:00 hr) or a shortened length of sleep (PSD condition). On the morning of day 2, the participants ran for 60 min at 65% of  V   ˙    O 2max  . Sleep duration was significantly shorter under the PSD condition (141.2 ± 13.3 min) than under the CON condition (469.0 ± 2.3 min, p < .0001). Serum hepcidin, plasma interleukin (IL)-6, serum haptoglobin, iron, and myoglobin levels did not differ significantly between the conditions (p > .05) on the morning (before exercise) of day 2. Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05). In conclusion, the present study demonstrated that a single night of PSD after an exercise session in the evening did not affect baseline serum hepcidin level the following morning. Moreover, a 60 min run the following morning increased serum hepcidin and plasma IL-6 levels significantly, but the exercise-induced elevations were not affected by PSD.",2020,"Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05).",['Ten recreationally trained males participated under two different conditions'],"['maximal oxygen uptake (  V', 'partial sleep deprivation (PSD']","['postexercise levels for the hematological variables', 'Serum hepcidin, plasma interleukin (IL)-6, serum haptoglobin, iron, and myoglobin levels', 'hepcidin levels', 'Sleep duration', 'baseline serum hepcidin level', 'serum hepcidin and plasma IL-6 levels', 'Partial sleep deprivation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0427498', 'cui_str': 'Serum haptoglobin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",,0.0639753,"Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05).","[{'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Aoi', 'Initials': 'A', 'LastName': 'Mamiya', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Badenhorst', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Auckland, New Zealand.'}]",Physiological reports,['10.14814/phy2.14450']
2369,32458567,Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial.,"OBJECTIVES


Current WHO guidelines recommend the treatment of all HIV-infected individuals with antiretroviral therapy (ART) to improve survival and quality of life, and decrease infection of others. MaxART is the first implementation trial of this strategy embedded within a government-managed health system, and assesses mortality as a secondary outcome. Because primary findings strongly supported scale-up of the 'treat all' strategy (hereafter Treat All), this analysis examines mortality as an additional indicator of its impact.
METHODS


MaxART was conducted in 14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention. All-cause, disease-related, and HIV-related mortality were analysed using the Cox proportional hazards model, censoring SoC participants at clinic transition. Median follow-up time among study participants was 292 days. There were 36/2034 deaths in SoC (1.77%) and 49/1371 deaths in Treat All (3.57%).
RESULTS


Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and Treat All interventions, respectively, the multivariable-adjusted 12-month all-cause mortality rates were 1.42% [95% confidence interval (CI): 0.66-2.17] and 1.60% (95% CI: 0.78-2.40), disease-related mortality rates were 1.02% (95% CI: 0.40-1.64) and 1.10% (95% CI: 0.46-1.73), and HIV-related mortality rates were 1.03% (95% CI: 0.40-1.65) and 0.99% (95% CI: 0.40-1.58). Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI: 0.52-2.11, P = 0.90), or HIV-related mortality (HR = 0.93, 95% CI: 0.46-1.87, P = 0.83).
CONCLUSION


There was no immediate benefit of the Treat All strategy on mortality, nor evidence of harm. Longer follow-up of participants is needed to establish long-term consequences.",2020,"Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI:","['14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention', 'Between September 2014 and August 2017', 's national standard of care', '3405 participants were enrolled']","['antiretroviral therapy vs. Eswatini', 'MaxART', 'antiretroviral therapy (ART']","['HIV-related mortality', 'mortality rates', 'survival and quality of life', 'disease-related mortality rates', 'Mortality', 'HIV-related mortality rates', 'mortality, nor evidence of harm']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}]",3405.0,0.426961,"Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI:","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Boston, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pasipamire', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chai', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reis', 'Affiliation': 'Leiden University Medical Center, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Delva', 'Affiliation': 'The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Khumalo', 'Affiliation': 'Eswatini National Network of People Living with HIV (SWANNEPHA), Mbabane, Eswatini.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zwane', 'Affiliation': 'SAfAIDS, Manzini, Eswatini.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fleming', 'Affiliation': 'Aidsfonds, Amsterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Directorate Office, Ministry of Health, Mbabane, Eswatini.'}]",HIV medicine,['10.1111/hiv.12876']
2370,32458640,Sequential Chemoradiotherapy Compared to Radiotherapy in Endometrial Carcinoma.,"BACKGROUND


The role of combined modality in the adjuvant treatment of Endometrial Cancer has not been established. This study aims to assess the benefits of Sequential Chemoradiotherapy (SCRT) compared to Radiotherapy (RT) alone in the treatment of patients with Endometrial Cancer.
METHODS


Retrospective analysis of patients with Endometrial Cancer stage I to stage III C at King Abdullah Medical city, Makkah. Each group of patients was assigned to receive External pelvic RT, brachytherapy or both. While a second group received SCRT consisting of six cycles of Carboplatin (AUC 5) and Paclitaxel 175 mg/m2 followed by radiotherapy.
RESULTS


Fifty-six women were treated of which 26 received SCRT and 30 received RT. The two groups had a median age of 58 years old ranging from 34 - 84 years old with no other statistically significant difference. Patients who received SCRT had poorer prognostic tumor characteris-tics. Median follow-up was 29.6 months (95% CI: 19.6-39.5 months). All deaths (n=5) were exclusively in the RT group. The 2 and 4-year OS rates were 100% and 100% in SCRT group versus 87.3% and 64.9% in RT group (hazard ratio [HR] 0.018 [95% CI: 0-24.4; p= 0.038); The 2- and 4-year DFS were 100% and 100% in SCRT group versus 78.1% and 43.9% in RT group (HR 0.102 [95% CI: 0.103-0.805; p= 0.008).
CONCLUSION


Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS. Randomized clinical trials are needed to determine the benefits of early Systemic Therapy.",2020,Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS.,"['patients with Endometrial Cancer', 'Endometrial Carcinoma', 'patients with Endometrial Cancer stage I to stage III C at King Abdullah Medical city, Makkah', 'Fifty-six women']","['RT', 'External pelvic RT, brachytherapy or both', 'Adjuvant chemotherapy', 'Sequential Chemoradiotherapy', 'Radiotherapy (RT) alone', 'SCRT', 'Sequential Chemoradiotherapy (SCRT', 'Carboplatin (AUC 5) and Paclitaxel 175 mg/m2 followed by radiotherapy', 'Radiotherapy']","['2- and 4-year DFS', 'prognostic tumor characteris-tics', '4-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0476089', 'cui_str': 'Endometrial carcinoma'}, {'cui': 'C0278798', 'cui_str': 'Endometrial cancer stage I'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}]",56.0,0.160064,Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS.,"[{'ForeName': 'Omima', 'Initials': 'O', 'LastName': 'Elemam', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Seham', 'Initials': 'S', 'LastName': 'Abdelkhalek', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Abdelmoety', 'Affiliation': 'Research Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Engy', 'Initials': 'E', 'LastName': 'Aboelnaga', 'Affiliation': 'Department of Radiotherapy , Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Baraka', 'Affiliation': 'Department of Biology, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zeeneldine', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.5.1327']
2371,32458647,"A Prospective Randomized Trial to Compare Safety, Acceptability and Efficacy of Thermal Ablation and Cryotherapy in a Screen and Treat Setting.","BACKGROUND


The prospective randomized study aimed to compare the safety, acceptability and efficacy of thermal ablation (TA) to that of cryotherapy in screen and treat setting.
METHODS


The participants were recruited prospectively in a community-based screening clinic in India. Women positive on visual inspection with acetic acid (VIA) test and/or Human Papillomavirus (HPV) test were assessed for eligibility for ablative treatment. Total 286 eligible women were randomized to receive either cryotherapy (N=150) or TA (N=136) performed by health workers. Colposcopy and cervical biopsy were performed on all, prior to treatment. Post-treatment follow-up was after one year with colposcopy and biopsy.
RESULTS


Both the treatment methods had high acceptability. Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them. Approximately 30% of women in both arms had histologic abnormalities, mainly CIN 1, and among those who attended follow-up 74.1% and 81.0% didn't have any CIN after cryotherapy and TA respectively.
CONCLUSION


TA is as acceptable and safe as cryotherapy in screen and treat setting. TA has the logistic advantages for the low-resourced settings as the machines are more portable, do not require costly refrigerant gas and battery-driven models are available. The cure rates for CIN 1+ lesions in our study were comparable between cryotherapy and TA.",2020,"Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them.","['N=136) performed by health workers', 'participants were recruited prospectively in a community-based screening clinic in India', 'Total 286 eligible women']","['thermal ablation (TA', 'Thermal Ablation and Cryotherapy', 'acetic acid (VIA) test and/or Human Papillomavirus (HPV', 'TA', 'cryotherapy (N=150) or TA']","['safety, acceptability and efficacy', 'histologic abnormalities', 'cure rates', 'pain']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",286.0,0.0659985,"Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them.","[{'ForeName': 'Dipanwita', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Ranajit', 'Initials': 'R', 'LastName': 'Mandal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mandal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Ghosh', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Srabani', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.5.1391']
2372,31779791,Natural History of Subclinical Atrial Fibrillation Detected by Implanted Loop Recorders.,"BACKGROUND


As new heart rhythm monitoring technologies emerge, subclinical atrial fibrillation (AF) signifies a future challenge to health care systems. The pathological characteristics of this condition are largely unknown.
OBJECTIVES


This study sought to characterize the natural history of subclinical AF in at-risk patients from the general population.
METHODS


The authors studied 590 individuals ≥70 years of age with ≥1 of hypertension, diabetes, previous stroke, or heart failure, without history of AF, undergoing long-term implantable loop recorder monitoring as part of the LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals) study. Baseline assessments included N-terminal pro-B-type natriuretic peptide (NT-proBNP). All day-to-day heart rhythm and symptom data were extracted from the device. Endpoints included AF burden, AF progression, symptom reports, and heart rate during AF.
RESULTS


A total of 685,445 monitoring days were available for analysis. Adjudicated AF episodes lasting ≥6 min were detected in 205 participants (35%). The AF burden was median 0.13% (interquartile range: 0.03% to 1.05%) of the monitoring time and changed by a factor of 1.31 (95% CI: 1.02 to 1.68) per doubling of NT-proBNP. AF episodes were present 2.7% (interquartile range: 1.0% to 15.7%) of monitoring days after debut. Progression to 24-h episodes was seen in 33 of the AF patients (16%), whereas 46 (22%) had no AF episodes in the last 6 months of monitoring or longer. Symptoms were absent in 185 (90%) at debut, and 178 (87%) never reported AF-related symptoms during follow-up. The averaged heart rate during AF was 96 (interquartile range: 83 to 114) beats/min, 24 (interquartile range: 9 to 41) beats/min faster than daytime sinus rates.
CONCLUSIONS


Although previously unknown AF was highly prevalent, the burden was low, and progression was limited. In addition, symptoms were scarce, and the heart rate was only modestly elevated. (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals [LOOP]; NCT02036450).",2019,AF episodes were present 2.7% (interquartile range: 1.0% to 15.7%) of monitoring days after debut.,"['Natural History of Subclinical', 'at-risk patients from the general population', '590 individuals\xa0≥70 years of age with\xa0≥1 of hypertension, diabetes, previous stroke, or heart failure, without history of AF, undergoing long-term implantable loop recorder monitoring as part of the LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals) study']",[],"['Progression to 24-h episodes', 'AF episodes', 'heart rate', 'AF burden, AF progression, symptom reports, and heart rate during AF', 'AF burden', 'averaged heart rate', 'Atrial', 'Fibrillation']","[{'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4552498', 'cui_str': 'Implantable loop recorder'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0420200', 'cui_str': 'Continuous ECG monitoring'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0232197', 'cui_str': 'Fibrillation'}]",,0.105242,AF episodes were present 2.7% (interquartile range: 1.0% to 15.7%) of monitoring days after debut.,"[{'ForeName': 'Søren Zöga', 'Initials': 'SZ', 'LastName': 'Diederichsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: Soeren.Zoega.Diederichsen@regionh.dk.'}, {'ForeName': 'Ketil Jørgen', 'Initials': 'KJ', 'LastName': 'Haugan', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mathias Buus', 'Initials': 'MB', 'LastName': 'Lanng', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Graff', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Derk', 'Initials': 'D', 'LastName': 'Krieger', 'Affiliation': 'University Hospital Zurich, University of Zurich, Zurich, Switzerland; Stroke Unit, Mediclinic City Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kronborg', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anders Gaarsdal', 'Initials': 'AG', 'LastName': 'Holst', 'Affiliation': 'Laboratory for Molecular Cardiology, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Højberg', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Laboratory for Molecular Cardiology, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.050']
2373,31826195,Cognitive stimulations effects and Taigeiko in elderly women's cognition: an intervention.,"OBJECTIVE


To evaluate the effectiveness of an intervention through cognitive stimulation associated with Taigeiko practice in memory performance and executive function of elderly women, compared to a group exposed to Taigeiko alone.
METHOD


A quasi-experimental study was performed with 16 elderly women. 10 were allocated to the experimental group (EG) submitted to 16 sessions of cognitive stimulation and Taigeiko, and 6 elderly women in the control group (CG) submitted to Taigeiko alone. Cognition was assessed before and after intervention by the tests: Rey Auditory-Verbal Learning (RAVLT); Rey-Osterrieth Complex Figure Test; Trail-Making Test; Stroop Effect; Digit Span Test and Semantic Verbal Fluency Test.
RESULTS


Both groups presented differences in RAVLT domains (EG p=0.004, CG p=0.005) and Stroop Effect (EG p=0.012; CG p=0.024). However, in EG, better scores were shown in the tests, although not statistically significant.
CONCLUSION


Taigeiko has been shown to be a potential activity in obtaining cognitive gains, independently of the associated cognitive stimulation.",2019,"Both groups presented differences in RAVLT domains (EG p=0.004, CG p=0.005) and Stroop Effect (EG p=0.012; CG p=0.024).","[""elderly women's cognition"", '16 elderly women', 'elderly women']","['Taigeiko practice', 'cognitive stimulation and Taigeiko, and 6 elderly women in the control group (CG) submitted to Taigeiko alone']",['Rey Auditory-Verbal Learning (RAVLT); Rey-Osterrieth Complex Figure Test; Trail-Making Test; Stroop Effect; Digit Span Test and Semantic Verbal Fluency Test'],"[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0871925', 'cui_str': 'Stroop Effect'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]",16.0,0.0117572,"Both groups presented differences in RAVLT domains (EG p=0.004, CG p=0.005) and Stroop Effect (EG p=0.012; CG p=0.024).","[{'ForeName': 'Alice Milani', 'Initials': 'AM', 'LastName': 'Nespollo', 'Affiliation': 'Universidade Federal de Mato Grosso. Cuiabá, Mato Grosso, Brazil.'}, {'ForeName': 'Samira Reschetti', 'Initials': 'SR', 'LastName': 'Marcon', 'Affiliation': 'Universidade Federal de Mato Grosso. Cuiabá, Mato Grosso, Brazil.'}, {'ForeName': 'Nathalie Vilma Pollo de', 'Initials': 'NVP', 'LastName': 'Lima', 'Affiliation': 'Universidade Federal de Mato Grosso. Cuiabá, Mato Grosso, Brazil.'}, {'ForeName': 'Tatiane Lebre', 'Initials': 'TL', 'LastName': 'Dias', 'Affiliation': 'Universidade Federal de Mato Grosso. Cuiabá, Mato Grosso, Brazil.'}, {'ForeName': 'Mariano Martínez', 'Initials': 'MM', 'LastName': 'Espinosa', 'Affiliation': 'Universidade Federal de Mato Grosso. Cuiabá, Mato Grosso, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2018-0133']
2374,31833909,"Effects of keto acid supplements on Chinese patients receiving maintenance hemodialysis: a prospective, randomized, controlled, single-center clinical study.","BACKGROUND


The effects of keto acid (KA) supplements on Chinese patients receiving maintenance hemodialysis (MHD) are unclear. This study aimed to evaluate the effects of KA supplementation on nutritional status, inflammatory markers, and bioelectric impedance analysis (BIA) parameters in a cohort of Chinese patients with MHD without malnutrition.
METHODS


This was a prospective, randomized, controlled, single-center clinical study conducted in 2011 till 2014. Twenty-nine patients with MHD were randomly assigned to a control (n = 14) or a KA (n = 15) group. The control group maintained a dietary protein intake of 0.9 g/kg/day. The KA group received additional KA supplement (0.1 g/kg/day). BIA was used to determine the lean tissue mass, adipose tissue mass, and body cell mass. The patients' nutritional status, dialysis adequacy, and biochemical parameters were assessed at the ends of the third and sixth months with t test or Wilcoxon rank-sum test.
RESULTS


The daily total energy intake for both groups was about 28 kcal/kg/day. After 6 months, the Kt/V (where K is the dialyzer clearance of urea, t is the dialysis time, and V is the volume of the distribution of urea) was 1.33 ± 0.25 in KA group, and 1.34 ± 0.25 in the control group. The median triceps skin-fold thickness in KA group was 12.00 and 9.00 mm in the control group. In addition, the median hand-grip strength in KA group was 21.10 and 25.65 kg in the control group. There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA. Both groups achieved dialysis adequacy and maintained nutritional status during the study.
CONCLUSIONS


In this cohort of Chinese patients with MHD, the patients in the control group whose dietary protein intake was 0.9 g/kg/day and total energy intake was 28 kcal/kg/day, maintained well nutritional status during study period. The KA supplement (0.1 g/kg/day) did not improve the essential amino acid/non-essential amino acid ratio, nor did it change the patients' mineral metabolism, inflammatory parameters, or body compositions.",2019,"There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA.","['Chinese patients receiving maintenance hemodialysis (MHD', '2011 till 2014', 'Chinese patients with MHD', 'Chinese patients with MHD without malnutrition', 'Chinese patients receiving maintenance hemodialysis', 'Twenty-nine patients with MHD']","['KA', 'additional KA supplement', 'KA supplementation', 'keto acid supplements', 'keto acid (KA) supplements']","['nutritional status, inflammatory markers, and bioelectric impedance analysis (BIA) parameters', 'anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA', 'dialysis adequacy and maintained nutritional status', 'lean tissue mass, adipose tissue mass, and body cell mass', 'total energy intake', 'median hand-grip strength', 'dietary protein intake', 'median triceps skin-fold thickness', 'daily total energy intake']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0022618', 'cui_str': 'Ketoacid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake'}, {'cui': 'C0424680', 'cui_str': 'Skin-fold thickness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",29.0,0.0236773,"There were no significant differences between the groups with respect to the anthropometry parameters, dialysis adequacy, serum calcium and phosphorus levels, inflammatory markers, and amino-acid profiles, or in relation to the parameters determined by BIA.","[{'ForeName': 'Hai-Long', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Nutrition, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shanxi Medical College Affiliated First Hospital, Taiyuan, Shanxi 030001, China.'}, {'ForeName': 'Yi-Fu', 'Initials': 'YF', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Shijiazhuang Third Hospital, Shijiazhuang, Hebei 050011, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Nephrology, Shanxi Medical College Affiliated Second Hospital, Taiyuan, Shanxi 030001, China.'}, {'ForeName': 'Wei-Qi', 'Initials': 'WQ', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Shi-Qin', 'Initials': 'SQ', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Chen-Die', 'Initials': 'CD', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Qiqihar Medical College Affiliated Third Hospital, Qiqihar, Heilongjiang 161000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Statistics, Institute of Basic Medical Sciences, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Nutrition, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Jian-Ling', 'Initials': 'JL', 'LastName': 'Tao', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Xue-Wang', 'Initials': 'XW', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000578']
2375,30184105,Effects of letrozole and clomiphene citrate on Wnt signaling pathway in endometrium of polycystic ovarian syndrome and healthy women†.,"Polycystic ovary syndrome (PCOS) is an endocrine disorder in women of reproductive age. In addition to anovulation, endometrial dysfunction can reduce fertility in PCOS. The cyclical changes of endometrium are controlled by estrogen and progesterone via modulating the Wnt/B-catenin pathway. Clomiphene citrate (CC) and letrozole are used to induce ovulation; unlike letrozole, there is a discrepancy between ovulation and pregnancy rates in CC-treated cycles. Because of the anti-estrogenic effects of CC on endometrium, we compared the expression of the key molecules of the Wnt/B-catenin pathway in the endometrium of women taking CC and letrozole. This study included PCOS and healthy women divided into the groups stimulated with letrozole (5 mg) or CC (100 mg) as well as NO-treatment groups. The endometrial thickness and hormonal profile were measured on day 12 of the menses. Using real-time polymerase chain reaction and western blot, we evaluated mRNA and protein expression of B-catenin, glycogen synthase kinase 3 beta (GSK3B), dickkopf Wnt signaling pathway inhibitor 1 (DKK1), and estrogen receptor 1 (ESR1) in the endometrial samples. Significantly, the mean serum estrogen and progesterone were lower and higher, respectively, in letrozole than CC groups. The endometrial thickness was significantly reduced in CC. The proteins expression of active B-catenin, inactive GSK3B, and ESR1 were significantly decreased in CC-treated groups. The mRNA and protein assessment of DKK1 showed significantly higher expression in CC. Our results indicate that letrozole can provide an acceptable activation of the Wnt/B-catenin pathway, resulting in adequate proliferation of endometrium in the women receiving letrozole compared to CC.",2019,"The proteins expression of active B-catenin, inactive GSK3B, and ESR1 were significantly decreased in CC-treated groups.","['Polycystic ovary syndrome (PCOS', 'endometrium of polycystic ovarian syndrome and healthy women†', 'PCOS and healthy women divided into the groups stimulated with', 'women of reproductive age']","['letrozole', 'letrozole and clomiphene citrate', 'letrozole (5 mg) or CC', 'Clomiphene citrate (CC) and letrozole']","['mean serum estrogen and progesterone', 'mRNA and protein expression of B-catenin, glycogen synthase kinase 3 beta (GSK3B), dickkopf Wnt signaling pathway inhibitor 1 (DKK1), and estrogen receptor 1 (ESR1', 'proteins expression of active B-catenin, inactive GSK3B, and ESR1', 'endometrial thickness', 'endometrial thickness and hormonal profile']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C0244988', 'cui_str': 'GSK-3beta'}, {'cui': 'C1520113', 'cui_str': 'Wnt Pathway'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121711', 'cui_str': 'Estrogen Receptor 1'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}]",,0.015329,"The proteins expression of active B-catenin, inactive GSK3B, and ESR1 were significantly decreased in CC-treated groups.","[{'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Mehdinejadiani', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Amidi', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mehdizadeh', 'Affiliation': 'Cellular and Molecular Research Center, Faculty of Advanced Technologies in Medicine, Department of Anatomy, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Department of Medical Biotechnology, Faculty of Allied Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Pazhohan', 'Affiliation': 'Department of Midwifery, Urmia Branch, Islamic Azad University, Urmia, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Alyasin', 'Affiliation': 'Department of Endocrinology and Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Mehdinejadiani', 'Affiliation': 'Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aligholi', 'Initials': 'A', 'LastName': 'Sobhani', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Biology of reproduction,['10.1093/biolre/ioy187']
2376,30250241,"The effect of brisk walking in the fasted versus fed state on metabolic responses, gastrointestinal function, and appetite in healthy men.","OBJECTIVE


To investigate the effect of brisk walking in the fasted versus fed state on gastric emptying rate (GER), metabolic responses and appetite hormone responses.
SUBJECTS/METHODS


Twelve healthy men completed two 45 min treadmill walks, fasted (FASTED) and followed consumption of a standardised breakfast (FED). GER of a standardised lunch was subsequently measured for 2 h using the  13 C-breath test method. Blood samples were collected at baseline, post-breakfast period, pre-exercise, immediately post exercise, pre-lunch then every 30 min following lunch for 2 h. Circulating concentrations of acylated ghrelin (GHR), glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), pancreatic polypeptide (PP), glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and cholesterol were measured. Subjective feelings of appetite were assessed at 15 min intervals throughout. Substrate utilisation was measured every 30 min, and continuously throughout exercise by indirect calorimetry.
RESULTS


No differences were observed for GER T ½  (FASTED 89 ± 22 vs. FED 89 ± 24 min, P = 0.868) nor T lag  (FASTED 55 ± 15 vs. FED 54 ± 14 min, P = 0.704). NEFA concentrations were higher in FASTED at pre-exercise, post exercise and 30 min post exercise (pre-lunch) (all P < 0.05) but no differences were observed for glucose, cholesterol or triglycerides. Carbohydrate oxidation was greater at all time-points during FED exercise (all P < 0.05). Minimal changes in appetite were observed post lunch ingestion with no differences in PYY or GHR observed between trials. GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch. A greater concentration of PP was observed in FED from pre-exercise to 30 min post lunch consumption (all P < 0.05). Insulin concentrations were higher in FED pre-exercise but higher in FASTED 1.5 h post lunch (P < 0.05).
CONCLUSION


These findings suggest that gastrointestinal function, hunger and appetite regulatory hormones are not sensitive to low-intensity bouts of physical activity and holds positive implications for weight management practices.",2019,"GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch.","['Twelve healthy men completed two', 'healthy men']","['brisk walking', '45\u2009min treadmill walks, fasted (FASTED) and followed consumption of a standardised breakfast (FED', 'glucagon-like peptide-1 ']","['GLP-1), peptide tyrosine tyrosine (PYY), pancreatic polypeptide (PP), glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and cholesterol', 'glucose, cholesterol or triglycerides', 'Carbohydrate oxidation', 'concentration of PP', 'Substrate utilisation', 'Insulin concentrations', 'Subjective feelings of appetite', 'metabolic responses, gastrointestinal function, and appetite', 'appetite', 'gastric emptying rate (GER), metabolic responses and appetite hormone responses', 'GLP-1 concentrations', 'NEFA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",12.0,0.0837764,"GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch.","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'McIver', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Mattin', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Gethin H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Adora M W', 'Initials': 'AMW', 'LastName': 'Yau', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK. a.yau@mmu.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0215-x']
2377,30538278,"Associations between reliable changes in depression and changes in BMI, total body fatness and visceral adiposity during a 12-month weight loss trial.","We investigated associations between changes in depression and body composition over a 12-month weight loss trial. Of the 298 adults (BMI > 27 m/kg 2 ), 219 with complete depression and body composition data were included. A 10-item Center for Epidemiologic Studies Depression Scale measured depression; dual-energy X-ray absorptiometry measured body composition. Multinomial logistic regression predicted reliable changes in depression by BMI, body fat (BF) and visceral adiposity (VAT). Multiplicative interaction terms tested modification by sex and ethnicity. Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18). Sex and ethnicity interaction terms were not significant. However, the relationship was only significant among females, among non-Latinos for BMI and BF, and among Latinos for VAT. Our study supports the association between depression and obesity and highlights the need for longitudinal studies investigating VAT and depression in diverse ethnic groups.",2019,"Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18).","['298 adults (BMI\u2009>\u200927\u2009m/kg 2 ), 219 with complete depression and body composition data were included']",[],"['depression and changes in BMI, total body fatness and visceral adiposity', 'body composition', 'depression by BMI, body fat (BF) and visceral adiposity (VAT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",298.0,0.0200185,"Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Cameron', 'Affiliation': 'University of California San Diego School of Medicine, 9500 Gilman Drive, La Jolla, CA, 92093, USA. ncameron1002@gmail.com.'}, {'ForeName': 'Job G', 'Initials': 'JG', 'LastName': 'Godino', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Skipper', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Dillon', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Waalen', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0272-1']
2378,30836440,Index of Pain Experience in Sickle Cell Anaemia (IPESCA): development from daily pain diaries and initial findings from use with children and adults with sickle cell anaemia.,,2019,,"['children and adults with sickle cell anaemia', 'Sickle Cell Anaemia (IPESCA']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",[],[],,0.0295481,,"[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Kawadler', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Stotesbury', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Koelbel', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Balfour', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Saunders', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rees', 'Affiliation': ""Department of Paediatric Haematology, King's College Hospital NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': ""Department of Haematology, Guy's and St. Thomas NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Baba', 'Initials': 'B', 'LastName': 'Inusa', 'Affiliation': ""Department of Paediatrics, Evelina Children's Hospital, Guy's and St. Thomas' National Health Service (NHS) Foundation Trust, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pelidis', 'Affiliation': ""Department of Paediatrics, Evelina Children's Hospital, Guy's and St. Thomas' National Health Service (NHS) Foundation Trust, London, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kesse-Adu', 'Affiliation': ""Department of Paediatrics, Evelina Children's Hospital, Guy's and St. Thomas' National Health Service (NHS) Foundation Trust, London, UK.""}, {'ForeName': 'Subarna', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': ""Department of Paediatric Haematology, King's College Hospital NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Moji', 'Initials': 'M', 'LastName': 'Awogbade', 'Affiliation': ""Department of Paediatric Haematology, King's College Hospital NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Clark', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Fenella J', 'Initials': 'FJ', 'LastName': 'Kirkham', 'Affiliation': 'Developmental Neurosciences, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liossi', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}]",British journal of haematology,['10.1111/bjh.15841']
2379,32442094,Sevoflurane Consumption During Inhalational Induction in Children: A Randomized Comparison of Minute Ventilation-Based Techniques With Standard Fixed Fresh Gas Flow Technique.,"This study was done to ascertain the optimum fresh gas flow (FGF) offering the best balance between rapid induction and minimal waste in pediatric patients. Forty-five children (weighing 10-20 kg) undergoing elective procedures under general anesthesia were randomly assigned into 3 groups: 0.5 minute ventilation (MV), MV, and S (FGF = 6 L/min). After priming the pediatric closed circuit, anesthesia was induced using a face mask with 8% sevoflurane in 100% oxygen (Draeger Primus Vista 120 anesthesia machine) at FGF-determined MV per group allocation. After loss of eyelash reflex (time 1 [T1]), intravenous cannulation (T2) and laryngeal mask airway (LMA) placement (T3) were done. Total sevoflurane consumed during induction (measured using logbook function) was the primary outcome. The cost of sevoflurane, any reflex movement, tachycardia (heart rate change > 20%), or additional propofol boluses required were also recorded. Sevoflurane consumption (3.8 vs 5.8 vs 9.2 mL) and cost of sevoflurane (104.2 vs 199.4 vs 312.8 rupees) were lowest in group 0.5 MV (P < .001). There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required. For pediatric sevoflurane induction, half the MV-based FGF provided similar anesthetic conditions for LMA insertion with minimum sevoflurane consumption.",2020,"There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required.","['Forty-five children (weighing 10-20 kg) undergoing elective procedures under general anesthesia', 'Children', 'pediatric patients']","['sevoflurane', 'Sevoflurane Consumption', 'Total sevoflurane', 'Minute Ventilation-Based Techniques With Standard Fixed Fresh Gas Flow Technique']","['eyelash reflex (time 1 [T1]), intravenous cannulation (T2) and laryngeal mask airway (LMA) placement (T3', 'cost of sevoflurane', 'cost of sevoflurane, any reflex movement, tachycardia (heart rate change > 20%), or additional propofol boluses', 'hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required', 'Sevoflurane consumption']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow'}]","[{'cui': 'C0422906', 'cui_str': 'Eyelash reflex'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",120.0,0.214744,"There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required.","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'is an assistant professor in the Department of Anaesthesia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Priyankar K', 'Initials': 'PK', 'LastName': 'Datta', 'Affiliation': 'is an anesthesiologist in the Department of Anaesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}]",AANA journal,[]
2380,32443329,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections.,"BACKGROUND


An increased frequency of toxoplasma encephalitis, caused by Toxoplasma gondii, has been reported in AIDS patients, especially in those with CD4+ T cell counts <100 cells/μL. Several guidelines recommend the combination of pyrimethamine, sulfadiazine, and leucovorin as the preferred regimen for AIDS-associated toxoplasma encephalitis. However, it is not commonly used in China due to limited access to pyrimethamine and sulfadiazine. The synergistic sulfonamides tablet formulation is a combination of trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX), and is readily available in China. Considering its constituent components, we hypothesize that this drug may be used as a substitute for sulfadiazine and TMP-SMX. We have therefore designed the present trial, and propose to investigate the efficacy and safety of synergistic sulfonamides combined with clindamycin for the treatment of toxoplasma encephalitis.
METHODS/DESIGN


This study will be an open-labeled, multi-center, prospective, randomized, and controlled trial. A total of 200 patients will be randomized into TMP-SMX plus azithromycin group, and synergistic sulfonamides plus clindamycin group at a ratio of 1:1. All participants will be invited to participate in a 48-week follow-up schedule once enrolled. The primary outcomes will be clinical response rate and all-cause mortality at 12 weeks. The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
DISCUSSION


We hope that the results of this study will be able to provide reliable evidence for the efficacy and safety of synergistic sulfonamides for its use in AIDS patients with toxoplasma encephalitis.
TRIAL REGISTRATION


This study was registered as one of 12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195. This study is still recruiting now, and the first patient was screened on March 22, 2019.",2020,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","['12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', '200 patients', 'AIDS patients with toxoplasma encephalitis']","['clindamycin', 'synergistic sulfonamides plus clindamycin', 'pyrimethamine', 'TMP-SMX plus azithromycin', 'trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX', 'pyrimethamine, sulfadiazine, and leucovorin']","['clinical response rate and all-cause mortality', 'clinical response rate and all-cause mortality at 48 weeks, and adverse events']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0085315', 'cui_str': 'Meningoencephalitis due to acquired toxoplasmosis'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0038760', 'cui_str': 'Sulfonamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034283', 'cui_str': 'Pyrimethamine'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038675', 'cui_str': 'Sulfadiazine'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.11167,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020146']
2381,32443332,"Research ""recover from illness defense complex"" helper T cell immune mechanisms based on the ""Fuxie"" theory clearing away heat evil thoroughly nourishing kidney treatment of recurrent blood-heat syndrome Psoriasis.","INTRODUCTION


Psoriasis vulgaris (PV) is a chronic, painful, disfiguring, and disabling dermatological disease, which affects the physical and mental health of patients and impacts their quality of life. Current conventional systemic therapies can be costly, present risks of side effects, have limited efficacy and commonly recur following treatment cessation. Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate. However, explicit evidence has not yet been obtained.
METHODS AND ANALYSIS


This is a pilot randomized controlled trial with the objective of investigating the effect of Jia Wei Liang Xue Xiao Feng San granules on relapse rate of recurrent PV and the correlation between Psoriasis area severity index (PASI) and key psoriasis-related cytokine changes and the number of cells. A total of 102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year. A total of 72 patients, with recurrent PV, will be randomized (1:1) to receive the oral Chinese herbal medicine Jia Wei Liang Xue Xiao Feng San or the oral Acitretin Capsule treatments for a period of 8 weeks. After this period, participants whose PASI scores improvement reached more than 75%, will undergo a 52-week follow-up phase.The primary outcome measures are as follows:The secondary study outcomes will include:This trial may provide a novel regimen for recurrent PV patients if the granules decrease recurrence rate without further adverse effects.
ETHICS AND DISSEMINATION


The ethics approval was provided by the Sichuan Traditional Chinese medicine regional ethics review committee. The ethics approval number is 2018KL-055. The design and the results of the study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900022766).",2020,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","['102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year', '72 patients, with recurrent PV']","['oral Chinese herbal medicine Jia Wei Liang Xue', 'Jia Wei Liang Xue Xiao Feng San granules']","['recurrence rate without further adverse effects', 'relapse rate of recurrent PV', 'PASI scores improvement']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.233689,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Hao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020161']
2382,32443343,Impact of twice- or three-times-weekly maintenance hemodialysis on patient outcomes: A multicenter randomized trial.,"AIM


Maintenance hemodialysis (MHD) frequency is associated with survival and complication rates. Achieving the optimal balance between healthcare, quality of life (QOL), and medical costs is challenging. We compared complications, inflammatory status, nutritional status, and QOL between patients with different MHD frequencies.
MATERIAL AND METHODS


This was a multicenter randomized trial of patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou. Patients were grouped according to their treatment schedule over 1 year: twice-weekly or 3-times-weekly. Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale) were assessed.
RESULTS


One hundred forty patients were included aged 29 to 68 years (mean age, 50.9 ± 4.3 years). There were no significant differences in infection, heart failure, or cerebral hemorrhage complications between the 2 groups (P = .664). Pre-dialysis hemoglobin, high-sensitivity C-reactive protein, serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05). After 1 year of MHD, both groups exhibited significant improvements in these parameters (all P < .05) with no significant differences between groups. Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy did not improve after treatment (all P > .05), although a difference in BUN was observed between the 2 groups (P < .001). QOL was superior in the twice-weekly group than in the 3-times-weekly group (all P < .05), except for social support, which was slightly better in the 3-times-weekly group than in the twice-weekly group.
CONCLUSIONS


Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly schedule. Even for patients with economic constraints, twice- or 3-times-weekly MHD should be selected with caution after consideration of BUN levels at baseline.",2020,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","['patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou', 'One hundred forty patients were included aged 29 to 68 years (mean age, 50.9\u200a±\u200a4.3 years', 'patient outcomes']",['twice- or three-times-weekly maintenance hemodialysis'],"['Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy', 'serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction', 'QOL', 'BUN', 'inflammatory and nutritional clinical outcomes and adverse events', 'infection, heart failure, or cerebral hemorrhage complications', 'survival and complication rates', 'healthcare, quality of life (QOL), and medical costs', 'Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale', 'complications, inflammatory status, nutritional status, and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",140.0,0.0354086,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Nephrology, Ruian People's Hospital, Ruian City, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Jinnv', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Fadong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zengqi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Chusheng', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020202']
2383,32443348,Adductor canal block with periarticular infiltration versus periarticular infiltration alone after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Effective postoperative analgesia may enhance early rehabilitation after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone for early postoperative pain treatment after TKA.
METHODS


After institutional review board approval, written informed consent was obtained from patients undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 30 mL of 0.5% ropivacaine and 100 mcg of clonidine. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. The primary outcome was morphine consumption in the first 24 hours. Secondary outcomes included pain scores, morphine consumption at 48 hours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay.
CONCLUSIONS


For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
TRIAL REGISTRATION NUMBER


researchregistry5490.",2020,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","['total knee arthroplasty (TKA', 'after total knee arthroplasty', 'patients undergoing elective TKA', 'early postoperative pain treatment after TKA']","['clonidine', 'periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics', 'Adductor canal block with periarticular infiltration versus periarticular infiltration alone', 'adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone', 'adductor canal blockade with 30\u200amL of 0.5% ropivacaine']","['morphine consumption', 'pain scores, morphine consumption at 48\u200ahours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay', 'morphine consumption and pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.331919,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","[{'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiacai', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, Qianjiang District Chinese medicine hospital of Chongqing, Chongqing, China.'}]",Medicine,['10.1097/MD.0000000000020213']
2384,32444152,Land-walking vs. water-walking interventions in older adults: Effects on aerobic fitness.,"BACKGROUND


Low cardiorespiratory fitness is an independent predictor of all-cause and cardiovascular mortality, and interventions that increase fitness reduce risk. Water-walking decreases musculoskeletal impact and risk of falls in older individuals, but it is unclear whether water-walking improves aerobic fitness in the same way as weight-dependent land-walking. This randomized controlled trial involved 3 intervention groups-a no-exercise control group (CG), a land-walking (LW) group, and a water-walking (WW) group-to investigate the comparative impacts of LW and WW to CG on fitness.
METHODS


Both exercise groups attended individually tailored, center-based, intensity-matched 3 × weekly sessions for 24 weeks, which progressed to 150 min of exercise per week. This was followed by a 24-week no-intervention period. Maximal graded exercise tests were performed on a treadmill at Weeks 0, 24, and 48.
RESULTS


Maximal oxygen uptake increased from Week 0 to Week 24 in both exercise groups (0.57 ± 0.62 mL/kg/min, 0.03 ± 0.04 L/min for LW; 0.93 ± 0.75 mL/kg/min, 0.06 ± 0.06 L/min for WW, mean ± SE) compared to the CG (-1.75 ± 0.78 mL/kg/min, -0.16 ± 0.05 L/min) (group × time, p < 0.05). Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s). By Week 48, the training-induced adaptations in the exercise groups returned to near baseline levels.
CONCLUSION


Our study supports current physical-activity recommendations that 150 min/week of moderate-intensity exercise produces improvements in fitness in previously sedentary older individuals. Also, LW and WW elicit similar improvements in fitness if conducted at the same relative intensities. Exercise-naïve older individuals can benefit from the lower impact forces and decreased risk of falls associated with WW without compromising improvements in cardiorespiratory fitness.",2020,"Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s).","['older individuals', 'Exercise-naïve older individuals', 'previously sedentary older individuals', 'older adults']","['moderate-intensity exercise', 'no-exercise control group (CG), a land-walking (LW) group, and a water-walking (WW', 'Land-walking vs. water-walking interventions', 'Water-walking']","['aerobic fitness', 'Maximal oxygen uptake', 'Time to exhaustion']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0350292,"Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Robey', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia; School of Medicine, The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, VIC 3010, Australia; North Western Mental Health, Melbourne Health, Melbourne, VIC 3010, Australia; Division of Psychiatry, WA Centre for Health & Ageing, The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3125, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia. Electronic address: danny.green@uwa.edu.au.'}]",Journal of sport and health science,['10.1016/j.jshs.2019.11.005']
2385,32444166,Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study.,"RESEARCH QUESTION


Is it feasible to perform a future definitive trial to determine the effectiveness of the positive reappraisal coping intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy?
DESIGN


This mixed method study aimed to establish the feasibility of conducting a multicentre randomized controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n = 75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants' subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016.
RESULTS


This study successfully gathered knowledge about the feasibility aspects of conducting a future multicentre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
CONCLUSIONS


The study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low-cost, convenient and easily deliverable intervention to provide much-needed support to a vulnerable patient population.",2020,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
","['women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy', 'Participants (n\u202f=\u202f75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups', 'two-year period between 2014 and 2016', 'women with RPL']","['positive reappraisal coping intervention (PRCI', 'PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires', 'PRCI']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],75.0,0.0546913,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'University Hospitals Southampton NHS Foundation Trust, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK; Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK. Electronic address: sarahl.bailey@soton.ac.uk.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'School of Psychology, Cardiff University, 70 Park Place, Cardiff Wales CF10 3AT, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kitson-Reynolds', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.022']
2386,32446108,Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.,"PTSD is associated with abnormalities in hypothalamic-pituitary-adrenal (HPA) axis activity. This includes enhanced HPA axis negative feedback, attenuated cortisol awakening response, and attenuated cortisol response to personal trauma script. Whether HPA axis function predicts treatment response or treatment related symptom reduction in PTSD remains unclear. In addition, the relative effects of different treatment modalities (i.e., medication and psychotherapy) on HPA axis is unclear. To address this gap in knowledge, the PROGrESS study examined cortisol awakening response across treatment in Veterans with chronic PTSD randomized to receive Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM). Salivary cortisol awakening response (CAR) was assessed at baseline, mid-treatment (week 6 and 12), post-treatment (week 24) and follow-up (week 36 and 52). Among males at baseline, combat veterans with PTSD showed lower CAR Area Under the Curve Increase (AUCi; M = 3.15, SD = 9.57) than Combat controls (M = 7.63, SD = 9.07; p = .02), demonstrating combat veterans with PTSD have a less responsive system than combat controls. Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03). When controlling for PTSD severity, higher baseline CAR AUCi was related to attenuated reduction in PTSD and lower likelihood of high treatment response over treatment (z = -2.06, p = .04).",2020,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).",['Veterans with chronic PTSD'],"['Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM']","['lower CAR Area Under the Curve Increase (AUCi', 'enhanced HPA axis negative feedback, attenuated cortisol awakening response', 'cortisol awakening response', 'Salivary cortisol awakening response (CAR', 'Cortisol awakening response', 'Higher PTSD severity', 'CAR AUCi']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0100699,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Healthcare System, 1670 Clairmont Road, Decatur, GA, 30033, Georgia; Emory University School of Medicine, 12 Executive Park, 3rdFloor, Atlanta, GA, 30029, Georgia. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rajaram', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025, United States.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University Medical School, Department of Psychiatry, One Park Avenue 8thFloor, New York, NY 10016, United States; Massachusetts General Hospital, Department of Psychiatry, One Bowdoin Square, 6th Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC, 29401, United States; Medical University of South Carolina, Department of Psychiatry, 67 President Street, Charleston, SC 29425, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States; Texas A&M Health Science Center, Department of Psychiatry and Behavioral Science, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104714']
2387,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND


Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS


Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS


For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS


While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
2388,32446158,Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.,"BACKGROUND


Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms.
METHOD


Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder.
MAIN RESULTS


The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
DISCUSSION AND CONCLUSION


We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.",2020,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","['panic disorder', 'patients with panic symptoms', 'Forty-one patients']","['mobile app-based interactive CBT', 'chatbot group (n\u202f=\u202f21) or control group', 'mobile app-based interactive cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Mobile app-based interactive CBT']","['severity of panic symptoms', 'severity of panic disorder', 'control helplessness score', 'social phobia score']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",41.0,0.0195038,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","[{'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jaejkim@yonsei.ac.kr.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104171']
2389,32449505,The effects of foot reflexology on chemotherapy-induced nausea and vomiting in digestive or lung cancer patients: protocol for randomized controlled trial.,"BACKGROUND


Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some patients report that they are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. Some chemotherapy for lung and digestive cancer patients is moderately or highly emitting.
OBJECTIVE


The primary objective of the present study is to assess the benefits of foot reflexology as a complement to conventional treatments on severity and frequency of chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives assessed are quality of life, anxiety, and self-esteem.
METHODS


This study is an open label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogic scale, and the frequency of this between the two groups. The secondary objectives will be assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items, Hospital and Anxiety Depression Scale and Body Image Questionnaire.
RESULTS


The present study was approved by the regional ethics committee (Île de France X CPP) on 3 April 2018 (n°ID RCB 2018-A00571-54). The enrollment started in Jun 2018 and as of November 2019, we enrolled 70 patients. The results are expected for the first quarter of 2020.
CONCLUSIONS


The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend this use. The present study will provide evidence on the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs.
CLINICALTRIAL


The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018) https://www.clinicaltrials.gov/ct2/show/NCT03508180?term=NCT03508180&draw=2&rank=1.",2020,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"['patients with chronic disease, including cancer', 'Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy', 'lung and digestive cancer patients', 'breast cancer patients', 'digestive or lung cancer patients']","['chemotherapy', 'Foot reflexology sessions', 'foot reflexology', 'conventional care with foot reflexology and conventional care without foot reflexology']","['Cancer Quality of Life Questionnaire - Core 30 items, Hospital and Anxiety Depression Scale and Body Image Questionnaire', 'quality of life, anxiety, and self-esteem', 'nausea and vomiting', 'severity and frequency of chemotherapy-induced nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",70.0,0.0859635,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Murat-Ringot', 'Affiliation': 'Hospices Civils de Lyon, Centre de Coordination en Cancérologie - IC HCL, 165 chemin du Grand Revoyet, PIERRE-BENITE, FR.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Hospices Civils de Lyon, Centre de Coordination en Cancérologie - IC HCL, 165 chemin du Grand Revoyet, PIERRE-BENITE, FR.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Hospices Civils de Lyon, Centre de Coordination en Cancérologie - IC HCL, 165 chemin du Grand Revoyet, PIERRE-BENITE, FR.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rentler', 'Affiliation': 'Hospices Civils de Lyon, Centre de Coordination en Cancérologie - IC HCL, 165 chemin du Grand Revoyet, PIERRE-BENITE, FR.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Subtil', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, LYON, FR.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Schott', 'Affiliation': 'HESPER EA7425, University Lyon1, LYON, FR.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Preau', 'Affiliation': 'Laboratoire GREPS EA 4163, Institut de Psychologie, Université Lyon 2, BRON, FR.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'Hospices Civils de Lyon, réanimation anesthésie, PIERRE-BENITE, FR.'}]",JMIR research protocols,['10.2196/17232']
2390,32449530,Cranberries after pelvic floor surgery for urinary tract infection prophylaxis: A randomized controlled trial.,"AIMS


Urinary tract infection (UTI) is a common complication after pelvic floor surgery. Antibiotics as prophylaxis may reduce the prevalence of UTI's by 50%, but bacterial resistance may be a large disadvantage, necessitating the search for other possible prophylactic options. Recent research found a 50% reduction in the rate of UTI's with the use of cranberry capsules after elective gynecologic surgery, suggesting that cranberry capsules may serve as a good prophylaxis. The aim of this study was to assess whether perioperative cranberry prophylaxis reduces the risk of clinical overt UTI after elective pelvic floor surgery with indwelling catheter.
METHODS


We conducted a single-center randomized, double-blind, placebo-controlled trial. Women were given cranberry capsules twice daily or identical placebo for 6 weeks, starting the day before surgery. The main endpoint of the trial was the incidence of UTI within 6 weeks after surgery, defined as clinical diagnosis and treatment of UTI by the medical doctor. Analyses were performed with the intention to treat.
RESULTS


Two hundred ten participants were included, 105 in each arm. There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
CONCLUSIONS


This trial shows no beneficial effect of adequately dosed cranberry prophylaxis in women undergoing pelvic floor surgery, although such effect cannot be ruled out in settings with a higher prevalence of UTI's.",2020,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","['after elective pelvic floor surgery with indwelling catheter', 'Two hundred ten participants were included, 105 in each arm', 'women undergoing pelvic floor surgery']","['cranberry prophylaxis', 'perioperative cranberry prophylaxis', 'cranberry capsules twice daily or identical placebo', 'Cranberries after pelvic floor surgery', 'placebo']","['prevalence of UTI', 'clinical diagnosis and treatment of UTI by the medical doctor', 'risk of clinical overt UTI']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",210.0,0.623332,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","[{'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Mooren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'Liefers', 'Affiliation': 'Department of Hospital Pharmacy, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}]",Neurourology and urodynamics,['10.1002/nau.24391']
2391,32449542,Should We Consider Deep Brain Stimulation Discontinuation in Late-Stage Parkinson's Disease?,"BACKGROUND


Subthalamic deep brain stimulation (STN-DBS) effects may decrease with Parkinson's disease (PD) progression. There is no indication if, when, and how to consider the interruption of DBS treatment in late-stage PD. The objective of the current study was to investigate the percentage of ""poor stimulation responders"" among late-stage PD patients for elaborating an algorithm to decide whether and when DBS discontinuation may be considered.
METHODS


Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5 years underwent a crossover, double-blind, randomized evaluation of acute effects of stimulation. Physicians, caregivers, and patients were blinded to stimulation conditions. Poor stimulation responders (MDS-UPDRS part III change <10% between stimulation on/medication off and stimulation off/medication off) maintained the stimulation off/medication on condition for 1 month for open-label assessment.
RESULTS


Thirty-six patients were included. The acute effect of stimulation was significant (17% MDS-UPDRS part III), with 80% of patients classified as ""good responders."" Seven patients were classified as ""poor stimulation responders,"" and the stimulation was switched off, but in 4 cases the stimulation was switched back ""on"" because of worsening of parkinsonism and dysphagia with a variable time delay (up to 10 days). No serious adverse effects occurred.
CONCLUSIONS


The vast majority of late-stage PD patients (92%) show a meaningful response to STN-DBS. Effects of stimulation may take days to disappear after its discontinuation. We present a safe and effective decisional algorithm that could guide physicians and caregivers in making challenging therapeutic decisions in late-stage PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"No serious adverse effects occurred.
","['Thirty-six patients were included', 'Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5\u2009years']","['Deep Brain Stimulation Discontinuation', 'Subthalamic deep brain stimulation (STN-DBS']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}]",[],36.0,0.041704,"No serious adverse effects occurred.
","[{'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fabbri', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Zibetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Mario Giorgio', 'Initials': 'MG', 'LastName': 'Rizzone', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giannini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Borellini', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of System Medicine, UOSD Parkinson, University of Rome ""Tor Vergata,"", Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bove', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Calandra-Buonaura', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Modugno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Piano', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Peppe', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Ardolino', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romagnolo', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Artusi', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Cortelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Romito', 'Initials': 'R', 'LastName': 'Luigi', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Eleopra', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Minafra', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pacchetti', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Tufo', 'Affiliation': 'U.O.C. Neurochirurgia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Cogiamanian', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Lopiano', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28091']
2392,32449567,Let Them Eat!,"The authors Tan PC et al (BJOG this issue) present a randomized controlled trial addressed a commonly held belief, although poorly studied, regarding the benefit of ""bowel rest"" in the setting of intractable nausea vomiting. I applaud this group for another randomized study in an area where this is no clear standard of care or best practice approach.",2020,I applaud this group for another randomized study in an area where this is no clear standard of care or best practice approach.,[],[],[],[],[],[],,0.11741,I applaud this group for another randomized study in an area where this is no clear standard of care or best practice approach.,"[{'ForeName': 'Rupsa C', 'Initials': 'RC', 'LastName': 'Boelig', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, Thomas Jefferson University Hospital, 833 Chestnut St 1st floor, Philadelphia, PA, 19107, United States.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16335']
2393,32449678,Arterial stiffness and kidney disease progression in the systolic blood pressure intervention trial
.,"AIMS


Arterial stiffness increases with both advancing age and chronic kidney disease (CKD) and may contribute to kidney function decline, but evidence is inconsistent. We hypothesized that greater baseline arterial stiffness (assessed as pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV)) was independently associated with kidney disease progression over the follow-up period (3.8 years) in the Systolic Blood Pressure Intervention Trial (SPRINT).
MATERIALS AND METHODS


8,815 SPRINT participants were included in the analysis of PP. 592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses. Cox proportional hazards analysis was used to examine the association between PP and time to kidney disease progression endpoints: (A) incident estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 in non-CKD participants at baseline; (B) 50% decline in eGFR, initiation of dialysis, or transplant in those with baseline CKD. Mixed model analyses examined the association of baseline PP/CFPWV with follow-up eGFR.
RESULTS AND CONCLUSION


Mean ± SD age was 68 ± 10 years, baseline PP was 62 ± 14 mmHg, and CFPWV was 10.8 ± 2.7 m/s. In the fully adjusted model, PP ≥ median was associated with an increased hazard of kidney disease progression endpoints (HR: 1.93 (1.43 - 2.61)). The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)). In fully adjusted models, higher baseline PP associated with eGFR decline (p < 0.0001 (all, CKD, non-CKD)), but baseline CFPWV did not. Among older adults at high risk for cardiovascular events, baseline PP was associated with kidney disease progression.
.",2020,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"['8,815 SPRINT participants were included in the analysis of PP', 'SD age was 68\xa0±\xa010 years, baseline PP was 62\xa0±', '592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses', 'older adults']",[],"['Mean\xa0±', 'Arterial stiffness and kidney disease progression', 'baseline arterial stiffness', 'glomerular filtration rate (eGFR', 'pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV', 'hazard of kidney disease progression endpoints', 'eGFR decline', 'kidney disease progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",8815.0,0.068225,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': ''}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': ''}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Glasser', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': ''}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN109982']
2394,31562908,Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement.,"BACKGROUND


Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes.
OBJECTIVES


This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade.
METHODS


The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex.
RESULTS


We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m 2  but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time.
CONCLUSIONS


In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.",2019,Women had higher prevalence of hypertension and glomerular filtration rate ,"['female and male patients', 'women and men undergoing transfemoral TAVR across the globe during the last decade', 'n\xa0=\xa05,261) male patients', 'patients undergoing', 'patients with severe aortic valve stenosis', 'We included 58% (n\xa0=\xa07,120) female and 42% ']","['Transfemoral Transcatheter Aortic Valve Replacement', 'Transfemoral aortic valve replacement (TAVR', 'TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration']","['mortality rates', 'procedural life-threatening or major bleeding', 'hypertension and glomerular filtration rate', 'risk of life-threatening or major bleeding', 'mortality', '30-day stroke', 'stroke rates', 'baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes', '30-day mortality and stroke']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",5261.0,0.160583,Women had higher prevalence of hypertension and glomerular filtration rate ,"[{'ForeName': 'Wieneke', 'Initials': 'W', 'LastName': 'Vlastra', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ""Department of Cardiology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'de Brito', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Barbanti', 'Affiliation': 'Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Catania, Italy.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Division of Cardiology, Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': ""D'Onofrio"", 'Affiliation': 'Division of Cardiac Surgery, University of Padova, Padua, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'University Hospital La Paz, Madrid, Spain; Instituto de Investigación Hospital La Paz (IDIPAZ), Madrid, Spain; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': ""D'Errigo"", 'Affiliation': 'National Centre for Global Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': 'Division of Cardiac Surgery, University of Padova, Padua, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Lunardi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pagnesi', 'Affiliation': 'Division of Cardiology, Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Berenguer', 'Affiliation': 'Cardiology Department, Hospital General de Valencia, Valencia, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Modine', 'Affiliation': 'Centre Hospitalier Universitaire, Lille, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address: r.delewi@amsterdamumc.nl.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.015']
2395,32453643,"The Effect of Inferior Turbinate Surgery on Quality of Life: A Randomized, Placebo-Controlled Study.","OBJECTIVE


The purpose of this prospective, randomized, single-blinded, placebo-controlled study was to investigate the effects of radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT) techniques on patients' quality of life (QOL) and to compare the techniques with a placebo procedure.
METHODS


A total of 98 consecutive patients with enlarged inferior turbinates due to persistent year-round rhinitis were randomized into placebo, RFA, diode laser, and MAIT groups at a ratio of 1:2:2:2. All the procedures were carried out under local anesthesia with the patients' eyes covered. Assessments were conducted prior to surgery and 3 months subsequent to the surgery. Quality of life was assessed with the Glasgow Health Status Inventory (GHSI).
RESULTS


The GHSI total score increased statistically significantly in all the groups, including placebo. There were no significant differences in the GHSI total score change between RFA, diode laser, and MAIT groups. The MAIT procedure improved the GHSI total score significantly more than the placebo procedure ( P  = .04).
CONCLUSION


All inferior turbinate surgery techniques lead to a significant improvement in the patients' QOL, and no significant differences were found between the techniques. The placebo treatment also improved the QOL significantly. Only the MAIT technique improved the QOL significantly more compared to placebo.",2020,"There were no significant differences in the GHSI total score change between RFA, diode laser, and MAIT groups.","['98 consecutive patients with enlarged inferior turbinates due to persistent year-round rhinitis', 'patients']","['Placebo', 'radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT) techniques', 'Inferior Turbinate Surgery', 'placebo, RFA, diode laser, and MAIT', 'placebo']","['GHSI total score', 'Quality of Life', 'QOL', 'quality of life (QOL', 'GHSI total score change', 'Quality of life', 'Glasgow Health Status Inventory (GHSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",98.0,0.0915848,"There were no significant differences in the GHSI total score change between RFA, diode laser, and MAIT groups.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kankaanpää', 'Affiliation': 'Department of Otorhinolaryngology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Harju', 'Affiliation': 'Department of Otorhinolaryngology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jura', 'Initials': 'J', 'LastName': 'Numminen', 'Affiliation': 'Department of Otorhinolaryngology, Tampere University Hospital, Tampere, Finland.'}]","Ear, nose, & throat journal",['10.1177/0145561320927944']
2396,32453647,Ultra Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Sub-Study.,"BACKGROUND-This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a sub-study of the PRONTO-T1D study. METHODS-Ambulatory glucose profiles were evaluated in 269 patients from PRONTO-T1D assigned to double-blind URLi (n=97) or lispro (n=99) given 0-2 minutes before the start of the meal (mealtime), or open-label URLi (n=73) given 20 minutes after the meal (postmeal URLi). Blinded CGM was used for up to 14 days prior to baseline and the 26-week primary endpoint. The primary objective was to compare mealtime URLi and lispro with respect to incremental area under the glucose concentration versus time curve from 0 to 2 hours (iAUC0-2hrs) after breakfast. RESULTS-Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference [LSM-diff] -28.1 mg*h/L, p=0.048) and for all meals combined. iAUC0-3hrs and iAUC0-4hrs were also reduced. Postmeal URLi resulted in similar postprandial glucose (PPG) control to mealtime lispro, but less optimal PPG control compared to mealtime URLi. Mealtime URLi increased daytime time in range (71-180 mg/dL [3.9-10.0 mmo/L]) (LSM-diff=+43.6 minutes, p=0.020) and decreased nighttime time in hypoglycemia (LSM-diff ≤70 mg/dL [3.9 mmol/L]=-11.5 minutes, p=0.009) compared to mealtime lispro. CONCLUSIONS-Results of this CGM sub-study support the improved PPG control seen with mealtime URLi in the PRONTO-T1D study and show that mealtime URLi resulted in improved daytime time in target range.",2020,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"['Type 1 Diabetes', '269 patients from PRONTO-T1D assigned to', 'adults with type 1 diabetes in a sub-study of the PRONTO-T1D study']","['continuous glucose monitoring (CGM', 'ultra rapid lispro (URLi) or lispro used in combination with insulin glargine', 'CGM', 'LSM-diff', 'double-blind URLi', 'lispro (n=99) given 0-2 minutes before the start of the meal (mealtime), or open-label URLi', 'Ultra Rapid Lispro', 'dL', 'Lispro']","['mealtime URLi and lispro with respect to incremental area under the glucose concentration versus time curve', 'daytime time', 'nighttime time in hypoglycemia (LSM-diff ≤70']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",269.0,0.0350752,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"[{'ForeName': 'Maciej Tadeusz', 'Initials': 'MT', 'LastName': 'Malecki', 'Affiliation': 'Jagiellonian University, Department of Metabolic Diseases, Krakow, Poland; malecki_malecki@yahoo.com.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; cao_dachuang@lilly.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; liu_rong_rl@lilly.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hardy', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; hardy_thomas_a@lilly.com.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia, United States; bbode001@aol.com.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, Minneapolis , Minnesota, United States; richard.bergenstal@parknicollet.com.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; bue-valleskey_juliana_m@lilly.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0129']
2397,32453660,"Response by Bhatt et al to Letter Regarding Article, ""REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States"".",,2020,,['3146 Patients Randomized in the United States'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],[],,0.0299455,,"[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Juliano', 'Affiliation': 'Amarin Pharma, Inc, Bridgewater, NJ (R.A.J., S.B.K.).'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Ketchum', 'Affiliation': 'Amarin Pharma, Inc, Bridgewater, NJ (R.A.J., S.B.K.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore (M.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047273']
2398,32453663,"Letter by Zhu et al Regarding Article, ""REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States"".",,2020,,['3146 Patients Randomized in the United States'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],[],,0.0423407,,"[{'ForeName': 'Houyong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Hangzhou Hospital of Traditional Chinese Medicine (Dingqiao District), Zhejiang, China (H.Z.).'}, {'ForeName': 'Xiaoqun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, China (X.X.).'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, China (J.H.).""}]",Circulation,['10.1161/CIRCULATIONAHA.120.046069']
2399,32453667,Biomechanical Functional Elbow Restoration of Acute Ulnar Collateral Ligament Tears: The Role of Internal Bracing on Gap Formation and Repair Stabilization.,"BACKGROUND


Biomechanical studies have compared augmented primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL) in the elbow. However, aUCL repair alone has not been compared with augmented repair or reconstruction techniques.
HYPOTHESIS


Internal bracing of aUCL repair provides improved time-zero stabilization in terms of gap formation, torsional stiffness, and residual torque compared with both repair alone and the modified docking technique, with enhanced valgus stability restoration to that of the native ligament.
STUDY DESIGN


Controlled laboratory study.
METHODS


We randomized 8 matched pairs of cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon. Valgus laxity testing was consecutively performed at 90° of flexion on the intact, torn, and repaired conditions as well as the previously assigned techniques. First, intact elbows were loaded up to 10 N·m valgus torque to evaluate time-zero ligament rotations at valgus moments of 2.5, 5.0, 7.5, and 10 N·m. Rotation controlled cycling was performed (total 1000 cycles) for each surgical condition. Gap formation, stiffness, and residual torque were analyzed. Finally, these elbows and 8 additional intact elbows underwent torque to failure testing (30 deg/min).
RESULTS


Repair alone revealed low torsional resistance and gapping, similar to the torn state. The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function. Although reconstruction revealed similar initial stiffness and residual torque compared with an intact ligament, a steady decrease of torsional resistance led to a completely loose state at higher valgus rotations. Analysis of covariance between all groups showed significantly less gap formation for augmented repair ( P  < .001). The native failure load and stiffness were significantly higher and were similar to those of augmented repair ( P  = .766).
CONCLUSION


Internal bracing of aUCL repair restored valgus stability to the native state with statistically improved torsional resistance, loading capability, and gap formation compared with reconstruction, especially at the upper load range of native aUCL function in the elbow.
CLINICAL RELEVANCE


We found that aUCL repair with an internal brace effectively improves time-zero mechanical characteristics and may provide stabilized healing with accelerated and reliable recovery without the need for a tendon graft.",2020,The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function.,['Acute Ulnar Collateral Ligament Tears'],"['cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon', 'primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL']","['torsional stiffness', 'low torsional resistance', 'time-zero mechanical characteristics', 'native failure load and stiffness', 'Biomechanical Functional Elbow Restoration', 'residual torque', 'torsional resistance', 'torsional resistance, loading capability, and gap formation', 'initial stiffness and residual torque', 'Gap formation, stiffness, and residual torque']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442632', 'cui_str': 'Dock - marine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0448547', 'cui_str': 'Structure of tendon of palmaris longus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",8.0,0.0337054,The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bachmaier', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Coen A', 'Initials': 'CA', 'LastName': 'Wijdicks', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Higgins', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Greiner', 'Affiliation': 'Sporthopaedicum, Regensburg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520921174']
2400,32462277,Effect of calcium hydroxide mixed with lidocaine hydrochloride on postoperative pain in teeth with irreversible pulpitis and symptomatic apical periodontitis: a preliminary randomized controlled prospective clinical trial.,"OBJECTIVES


To investigate the effect of calcium hydroxide mixed with lidocaine HCl on postoperative spontaneous pain.
MATERIALS AND METHODS


Sixty patients having irreversible pulpitis and symptomatic apical periodontitis with a preoperative spontaneous pain and percussion pain which was more than 50 on a visual analogue scale (100 mm VAS) were included in this study. After the preparation of the root canals, the patients were randomly distributed into two groups according to the calcium hydroxide vehicle, control group (mixed with saline) and calcium hydroxide mixed with lidocaine HCl (n = 30). Postoperative spontaneous pain scores were recorded by a VAS every day for a week. Data were analysed using one-way analysis of variance, chi-squared test and Mann-Whitney U tests (p = 0.05).
RESULTS


The calcium hydroxide mixed with lidocaine HCl group resulted in significantly less pain compared with the calcium hydroxide mixed with saline group during days 1 to 4 (p < 0.05). There were no significant differences between the groups in terms of postoperative percussion pain levels (p > 0.05).
CONCLUSION


Within the limitations of this study, it can be concluded that the calcium hydroxide mixed with lidocaine HCl can be beneficial in reducing postoperative pain in teeth with irreversible pulpitis and symptomatic apical periodontitis.
CLINICAL RELEVANCE


The calcium hydroxide mixed with lidocaine HCl can be beneficial in reducing postoperative pain in teeth with irreversible pulpitis and symptomatic apical periodontitis.
CLINICAL REGISTRATION NUMBER


TCTR20181121003.",2020,"There were no significant differences between the groups in terms of postoperative percussion pain levels (p > 0.05).
","['teeth with irreversible pulpitis and symptomatic apical periodontitis', 'Sixty patients having irreversible pulpitis and symptomatic apical periodontitis with a preoperative spontaneous pain and percussion pain which was more than 50 on a visual analogue scale (100\xa0mm VAS']","['lidocaine hydrochloride', 'calcium hydroxide vehicle, control group (mixed with saline) and calcium hydroxide mixed with lidocaine HCl', 'calcium hydroxide', 'lidocaine HCl', 'calcium hydroxide mixed with lidocaine HCl']","['postoperative pain', 'postoperative spontaneous pain', 'pain', 'postoperative percussion pain levels', 'Postoperative spontaneous pain scores']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.12171,"There were no significant differences between the groups in terms of postoperative percussion pain levels (p > 0.05).
","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Arslan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Health Sciences University, İstanbul, Turkey.'}, {'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Doğanay Yıldız', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Bursa Uludağ University, 16059, Bursa, Turkey. dtezgidoganay@gmail.com.'}, {'ForeName': 'Hüseyin Sinan', 'Initials': 'HS', 'LastName': 'Topçuoğlu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Tepecik', 'Affiliation': 'Private Practice, Dental Clinic, İstanbul, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Taş', 'Affiliation': 'Çorlu Oral and Dental Health Hospital, Tekirdağ, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03354-w']
2401,32462307,Comorbid anxiety and irritability symptoms and their association with cognitive functioning in children with ADHD.,"Anxiety and irritability symptoms frequently co-occur in children with Attention-Deficit/Hyperactivity Disorder (ADHD). This study aims to investigate whether irritability and anxiety are uniquely associated with performance on measures of cognitive functioning in children with ADHD and whether these associations hold when accounting for confounding variables. Baseline data was used from a randomised controlled trial of cognitive behavioural therapy for anxiety in children with ADHD (N = 219, 8-13 years). Anxiety was assessed using the child- and parent-reported Spence Children's Anxiety Scale, while irritability was assessed using the parent-reported Affective Reactivity Index. Children completed the National Institutes of Health Toolbox - Cognition Battery. Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03). These associations did not survive correction for multiple comparisons. There was little evidence of an association between anxiety or irritability symptoms and cognitive functioning. Frequent co-occurrence of anxiety and irritability suggests clinicians working with children with ADHD should assess co-morbid symptom profiles to inform the provision of optimum care.",2020,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","['children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD']",['cognitive behavioural therapy'],"['Anxiety and irritability symptoms', 'Comorbid anxiety and irritability symptoms', ""Spence Children's Anxiety Scale, while irritability"", 'Anxiety', 'anxiety or irritability symptoms and cognitive functioning', 'irritability and anxiety', 'List Sort Working Memory Test', 'Higher symptoms of anxiety', 'symptoms of irritability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0542262,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia. nicolacread@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00658-z']
2402,32462341,Retro-equatorial inferior oblique myopexy for treatment of inferior oblique overaction.,"AIM


To compare the effectiveness of inferior oblique retroequatorial myopexy and inferior oblique myectomy in correction of inferior oblique overaction (IOOA).
PATIENTS AND METHODS


This was a pilot study study including forty patients with primary IOOA of all grades, with or without primary position horizontal deviations. Patients were randomized to have either IO retroequatorial myopexy, group A, or IO myectomy, group B. Success was defined as elimination of the IOOA at 6 months postoperatively. Secondary outcome measures included residual or recurrent elevation in adduction, development of postoperative hypotropia in adduction, postoperative contralateral IOOA, major intraoperative complications, and reversibility of the procedure.
RESULTS


At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1). The incidence of residual IOOA in myopexy group was significantly higher in patients with higher preoperative grades of IOOA (P ˂ 0.001). While this difference was not statistically significant among patients in myectomy group (P = 0.09). Collapse of V-pattern was acheived in nine (69%) patients in myopexy group compared with 8 (57%) in myectomy group with a statistically significant difference (P ≤ 0.001). No patients in myopexy group developed postoperative hypotropia in adduction or postoperative contralateral IOOA, compared with eight (22%) patients of myectomy group (P = 0.002) who developed postoperative hypotropia and two (66.6%) patients with unilateral IOOA who developed contralateral IOOA in myectomy group (P ˂ 0.001). No intraoperative complications were encountered in either group. postoperative.
CONCLUSIONS


Retroequatorial myopexy of the inferior oblique is as effective as inferior oblique myectomy in eliminating lower and moderate grades of primary IOOA; however, it is more effective in collapsing V-pattern associated with IOOA, and is not associated with postoperative hypotropia or contralateral IOOA after unilateral surgery. It can be used as a safe, reversible alternative to myectomy; however, it is not suitable for high grades of IOOA.",2020,"At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1).","['forty patients with primary IOOA of all grades, with or without primary position horizontal deviations']","['Retro-equatorial inferior oblique myopexy', 'IO retroequatorial myopexy', 'inferior oblique retroequatorial myopexy and inferior oblique myectomy']","['intraoperative complications', 'contralateral IOOA', 'postoperative hypotropia', 'incidence of residual IOOA', 'Collapse of V-pattern', 'postoperative hypotropia in adduction or postoperative contralateral IOOA', 'success rate', 'residual or recurrent elevation in adduction, development of postoperative hypotropia in adduction, postoperative contralateral IOOA, major intraoperative complications, and reversibility of the procedure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444508', 'cui_str': 'Primary position'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0582817', 'cui_str': 'Inferior oblique muscle structure'}, {'cui': 'C0395358', 'cui_str': 'Inferior oblique myectomy'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0152208', 'cui_str': 'Hypotropia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",40.0,0.0367,"At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1).","[{'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Kasem', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Metwally', 'Affiliation': 'Memorial Institute of Ophthalmic Research, Giza, Egypt.'}, {'ForeName': 'Ibrahim T', 'Initials': 'IT', 'LastName': 'El-Adawy', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ameera G', 'Initials': 'AG', 'LastName': 'Abdelhameed', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt. amiragamal287@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04742-4']
2403,32462427,Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial.,"While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) promote recovery, few randomized controlled trials (RCT) have assessed cell therapy in humans. In this RCT, we assessed the safety, feasibility, and efficacy of intravenous autologous bone marrow-derived MSCs in subacute stroke. ISIS-HERMES was a single-center, open-label RCT, with a 2-year follow-up. We enrolled patients aged 18-70 years less than 2 weeks following moderate-severe ischemic carotid stroke. Patients were randomized 2:1 to receive intravenous MSCs or not. Primary outcomes assessed feasibility and safety. Secondary outcomes assessed global and motor recovery. Passive wrist movement functional MRI (fMRI) activity in primary motor cortex (MI) was employed as a motor recovery biomarker. We compared ""treated"" and ""control"" groups using as-treated analyses. Of 31 enrolled patients, 16 patients received MSCs. Treatment feasibility was 80%, and there were 10 and 16 adverse events in treated patients, and 12 and 24 in controls at 6-month and 2-year follow-up, respectively. Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002). Intravenous autologous MSC treatment following stroke was safe and feasible. Motor performance and task-related MI activity results suggest that MSCs improve motor recovery through sensorimotor neuroplasticity.ClinicalTrials.gov Identifier NCT00875654.",2020,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","['Subacute Ischemic Stroke', 'primary motor cortex (MI', '31 enrolled patients, 16 patients received', 'subacute stroke', 'enrolled patients aged 18-70\xa0years less than 2\xa0weeks following moderate-severe ischemic carotid stroke']","['intravenous MSCs', 'intravenous autologous bone marrow-derived MSCs', 'Intravenous autologous MSC', 'MSCs', 'Autologous Mesenchymal Stem Cells']","['task-related fMRI activity in MI-4a', 'global and motor recovery', 'safety, feasibility, and efficacy', 'motor-NIHSS', 'feasibility and safety', 'motor-Fugl-Meyer scores', 'Passive wrist movement functional MRI (fMRI) activity', 'Barthel Index, NIHSS, and modified-Rankin scores']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}]",31.0,0.338725,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","[{'ForeName': 'Assia', 'Initials': 'A', 'LastName': 'Jaillard', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France. Jaillard@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hommel', 'Affiliation': 'AGEIS EA 7407, Université Grenoble Alpes (UGA), Grenoble, France.'}, {'ForeName': 'Anaick', 'Initials': 'A', 'LastName': 'Moisan', 'Affiliation': 'Cell Therapy and Engineering Unit, EFS Rhône Alpes Auvergne, Saint Ismier, France.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zeffiro', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Favre-Wiki', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Barbieux-Guillot', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Vadot', 'Affiliation': 'Stroke Unit, CH Annecy-Genevois, Epagny Metz-Tessy, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Marcel', 'Affiliation': 'Stroke Unit, CH Métropole Savoie, Chambéry, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Lamalle', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Grand', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Detante', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational stroke research,['10.1007/s12975-020-00787-z']
2404,32462483,Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial.,"Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Mode of surfactant administration has evolved towards less invasive technique in the last few years. We randomised 58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive surfactant by InSurE or minimally invasive surfactant therapy (MIST). Non-invasive positive pressure ventilation (NIPPV) was used as primary respiratory support. The main objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32). No difference was observed in terms of hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality.Conclusion: There is no difference between MIST and InSurE in preterm neonates with RDS with NIPPV as a primary mode of respiratory support. Larger multicentre studies are needed to further explore differences in treatment failure and other secondary outcomes.Trial registration: www.ctri.nic.in id CTRI/2019/03/017992, registration date March 8, 2019.What is Known• InSurE is commonly used for many years for treatment of RDS in preterm neonates.• MIST has been introduced as a newer tool.What is New• MIST with feeding tube is comparable with InSurE in preterm infants with RDS in developing countries.•NIPPV can be used as primary respiratory support for MIST.",2020,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","['Preterm neonates with respiratory distress syndrome (RDS', 'preterm infants with RDS', 'preterm neonates with RDS with', '58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive', 'preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation']","['surfactant by intubate surfactant extubate (InSurE) technique', 'Minimally invasive surfactant therapy', 'invasive positive pressure ventilation (NIPPV', 'surfactant by InSurE or minimally invasive surfactant therapy (MIST', 'NIPPV']","['need of IMV', 'hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality', 'need of invasive mechanical ventilation (IMV', 'life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",58.0,0.200468,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","[{'ForeName': 'Bhupendra Kumar', 'Initials': 'BK', 'LastName': 'Gupta', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Anindya Kumar', 'Initials': 'AK', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Suchandra', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India. bijansaha18@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03682-9']
2405,32462496,Intermittent Cerebellar Theta Burst Stimulation Improves Visuo-motor Learning in Stroke Patients: a Pilot Study.,"The cerebellum plays a critical role in promoting learning of new motor tasks, which is an essential function for motor recovery. Repetitive transcranial magnetic stimulation (rTMS) of the cerebellum can be used to enhance learning. In this study, we investigated the effects of cerebellar intermittent theta burst stimulation (c-iTBS), a high-frequency rTMS protocol, on visuo-motor learning in a sample of hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery. Eight stroke patients were enrolled for the purposes of the study in the chronic stage of recovery (i.e., at least 6 months after stroke). In two sessions, Patients were randomly assigned to treatment with real or sham c-iTBS applied over the cerebellar hemisphere ipsilateral to the affected body side. c-iTBS was applied immediately before the learning phase of a visuo-motor adaptation task. Real, but not sham, c-iTBS improved visuo-motor learning as revealed by an increased performance in of the learning phase of the visuo-moto adaptation task. Moreover, we also found that real but not sham c-iTBS induced a sustained improvement in the re-adaptation of the recently learned skill (i.e., when patients were re-tested after 30 min). Taken together, these data point to c-iTBS as a potential novel strategy to promote motor learning in patients with stroke.",2020,"Real, but not sham, c-iTBS improved visuo-motor learning as revealed by an increased performance in of the learning phase of the visuo-moto adaptation task.","['Eight stroke patients were enrolled for the purposes of the study in the chronic stage of recovery (i.e., at least 6\xa0months after stroke', 'hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery', 'Stroke Patients', 'patients with stroke']","['real or sham c-iTBS', 'cerebellar intermittent theta burst stimulation (c-iTBS', 'Intermittent Cerebellar Theta Burst Stimulation', 'Repetitive transcranial magnetic stimulation (rTMS']",[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]",[],,0.0541559,"Real, but not sham, c-iTBS improved visuo-motor learning as revealed by an increased performance in of the learning phase of the visuo-moto adaptation task.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bonnì', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Motta', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Maria Concetta', 'Initials': 'MC', 'LastName': 'Pellicciari', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Elias Paolo', 'Initials': 'EP', 'LastName': 'Casula', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Alex Martino', 'Initials': 'AM', 'LastName': 'Cinnera', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maiella', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Picazio', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sallustio', 'Affiliation': 'Comprehensive Stroke Center, Department of Systems Medicine, University of Tor Vergata, Rome, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy. g.koch@hsantalucia.it.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01146-2']
2406,32462509,Effect of a geriatric intervention aiming to improve polypharmacy in nursing homes.,"PURPOSE


To examine the effect of an intervention comprising professional support by a geriatrician engaged in a quality care indicators' audit for nursing home (NH) staff on reducing polypharmacy.
METHODS


Of a total of 3709 NH residents, 90 NHs (2026 residents) were allocated to a light intervention and 85 NHs (1683 residents) to a strong intervention group.
RESULTS


Mixed-effect linear model found no significant variation in the total number of medications over time (β-coefficient for interaction 0.007, 95% CI - 0.15, 0.16). Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02 p 0.03 for the strong intervention group and - 0.06 SE 0.02 p 0.001 for the light intervention group) and a statistically significant increase in the analgesics use.
CONCLUSION


The possibility that a simple audit intervention might reduce psychotropic prescriptions deserves further investigation.",2020,Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02,"['nursing homes', 'Of a total of 3709 NH residents', '90 NHs (2026 residents']","['light intervention and 85 NHs (1683 residents) to a strong intervention group', 'geriatric intervention']","['analgesics use', 'total number of medications over time (β-coefficient']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",3709.0,0.0270268,Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'El Haddad', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France. kamal.elhaddad@hotmail.com.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}, {'ForeName': 'Clarisse Laffon', 'Initials': 'CL', 'LastName': 'de Mazieres', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}]",European geriatric medicine,['10.1007/s41999-019-00279-w']
2407,32445557,Compression of Myofascial Trigger Points With a Foam Roller or Ball for Exercise-induced Anterior Knee Pain: A Randomized Controlled Trial.,"Objective


The study aimed to evaluate the effectiveness of compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles, on exercise-induced, anterior knee pain in fitness runners.
Design


The research team designed a randomized controlled trial.
Setting


The study took place in the Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China.
Participants


A total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center.
Intervention


The participants were randomly assigned to one of 4 groups, with 20 participants in each group: (1) the MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention. For the MG intervention, participants' MTrPs were compressed with a foam roller or ball for 30 minutes once every 5 days for 2 months. After each compression, the MG+SG group received static stretching immediately.
Outcome Measures


A visual analog scale (VAS) and a participant's range of motion (ROM) of the knee were assessed at baseline, after 4 weeks of the intervention, immediately postintervention, and at a follow-up at 8 weeks postintervention. The effectiveness of the treatment in the different groups was also compared.
Results


Immediately postintervention, 18 participants (90%) in MG+SG group, 12 (60%) in MG group, and 8 (40%) in the SG group were pain free. Compared with those at baseline, the VAS scores of the MG+SG group significantly improved between baseline and postintervention and were unchanged at the eight-week follow-up. In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
Conclusions


Compression of MTrPs with a foam roller or ball, combined with static stretching, was more effective than either the compression only or static stretching only.",2020,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
","['induced Anterior Knee Pain', 'Participants\n\n\nA total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center', 'fitness runners', 'Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China']","['MG+SG', 'MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention', 'compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles', 'Foam Roller or Ball for Exercise', 'static stretching immediately']","['VAS scores and ROMs of the knee', ""visual analog scale (VAS) and a participant's range of motion (ROM) of the knee"", 'pain free', 'VAS scores']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",80.0,0.0309948,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Qiangmin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Opoku Antwi', 'Affiliation': ''}, {'ForeName': 'Thitham', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2408,32445558,Effect of Electroacupuncture on Postoperative Gastrointestinal Recovery in Patients Undergoing Thoracoscopic Surgery: A Feasibility Study.,"BACKGROUND The aim of this study was to study the feasibility and acceptability of electroacupuncture (EA) for preventing postoperative gastrointestinal complications in patients undergoing thoracoscopic segmentectomy/lobectomy. MATERIAL AND METHODS Sixty patients who underwent video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group). Patients in the EA group were given 30 minutes of bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37)] at 3 time points (24 hours before surgery, and 4 hours and 24 hours after surgery). The primary outcomes were recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation. Secondary outcomes included postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay. RESULTS We recruited 60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group. In total, 57 participants completed the study. With the exception of one participant in the EA group, all participants completed all three sessions of EA. The one exclusion was a case where a paravertebral block was not used during the surgery. Qualitative findings from the acceptability questionnaire indicated that participants viewed the EA treatment as acceptable. After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001). The EA group showed improved outcomes compared to the UC group in terms of time to first flatus (20.8±4.6 versus 24.1±6.2 hours, P=0.026) and defecation (53.9±6.0 versus 57.5±7.2 hours, P=0.046). No significant differences appeared regarding AD, rescue medication, or duration of hospitalization. PONV and pain intensity were similar in both groups at the recorded time periods. CONCLUSIONS EA is feasible and acceptable to patients undergoing VATS surgery. Our preliminary findings of EA promoting postoperative recovery of gastrointestinal function warrants large randomized controlled trials.",2020,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","['57 participants completed the study', 'Sixty patients who underwent', '60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group', 'patients undergoing VATS surgery', 'patients undergoing thoracoscopic segmentectomy/lobectomy', 'Patients Undergoing Thoracoscopic Surgery']","['electroacupuncture (EA', 'Electroacupuncture', 'bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37', 'EA', 'video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group']","['time to first flatus', 'PONV and pain intensity', 'postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay', 'defecation', 'recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation', 'AD, rescue medication, or duration of hospitalization', 'Postoperative Gastrointestinal Recovery', ""participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort"", 'postoperative gastrointestinal complications']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450534', 'cui_str': 'ST37'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}]",60.0,0.0873528,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Weiqian', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology (RMIT) University, Melbourne, Australia.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Pharmacology, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Fangbing', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920648']
2409,32449152,Long-term effectiveness of web-based cognitive behavioral therapy for patients with eating disorders.,"PURPOSE


To evaluate the long-term effectiveness of a web-based therapist-delivered cognitive behavioral therapy (CBT) for patients with eating disorders (ED).
METHODS


We used follow-up data from a randomized controlled trial that evaluated a web-based CBT on ED psychopathology and related health, compared to a waiting list control (WL) condition. As participants of the WL condition started the intervention after their waiting period, follow-up data included participants from both groups. The primary outcome was change from baseline, at 3, 6, and 12-month intervals in ED psychopathology, analyzed using mixed models for repeated measures. Secondary outcomes included body dissatisfaction, BMI, physical health, mental health, self-esteem, quality of life, and social functioning.
RESULTS


The population comprised 212 participants in total, in three subgroups: bulimia nervosa (BN; n = 44), binge eating disorder (BED; n = 83), and ED not otherwise specified (EDNOS; n = 85). Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life. Most effects were found for all three subgroups, except for long-term improvements in self-esteem and quality of life among participants with BN and EDNOS.
CONCLUSION


This study showed long-term sustainability of treatment effects up to 1-year post-treatment of a web-based therapist-delivered CBT for patients with various ED.
LEVEL OF EVIDENCE


Level IV, evidence obtained from multiple time series analysis, with intervention.
UNIQUE CLINICAL TRIAL NUMBER


NTR2415-Dutch Trial Registry (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415).",2020,"Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life.","['patients with eating disorders', 'patients with various ED', '212 participants in total, in three subgroups: bulimia nervosa (BN; n\u2009=\u200944), binge eating disorder (BED; n\u2009=\u200983), and ED not otherwise specified (EDNOS; n\u2009=\u200985', 'patients with eating disorders (ED']","['web-based cognitive behavioral therapy', 'web-based therapist-delivered cognitive behavioral therapy (CBT']","['self-esteem and quality of life', 'body dissatisfaction, BMI, physical health, mental health, self-esteem, quality of life, and social functioning', 'ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.123607,"Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life.","[{'ForeName': 'Elke D', 'Initials': 'ED', 'LastName': 'Ter Huurne', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands. e.terhuurne@gmail.com.'}, {'ForeName': 'Hein A', 'Initials': 'HA', 'LastName': 'de Haan', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'Postel', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Cor A J', 'Initials': 'CAJ', 'LastName': 'DeJong', 'Affiliation': 'Nijmegen Institute for Scientist-Practitioners in Addiction, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanne E L', 'Initials': 'JEL', 'LastName': 'VanDerNagel', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00929-0']
2410,32449174,"Pharmacokinetic and pharmacodynamic effects of ravulizumab and eculizumab on complement component 5 in adults with paroxysmal nocturnal haemoglobinuria: results of two phase 3 randomised, multicentre studies.","Ravulizumab, a novel long-acting complement component 5 (C5) inhibitor administered every 8 weeks (q8w), was non-inferior to eculizumab for all efficacy outcomes in two randomised, open-label, phase 3 trials in C5 inhibitor-naïve (Study 301) and eculizumab-experienced (Study 302) adult patients with paroxysmal nocturnal haemoglobinuria (PNH). This pre-specified analysis characterised ravulizumab pharmacokinetics (PK), pharmacodynamics (PD; free C5 levels), and PD differences between medications (Study 301, n = 246; Study 302, n = 195). Ravulizumab PK parameters were determined using non-compartmental analysis. Serum free C5 was quantified with a Gyros-based fluorescence assay (ravulizumab) and an electrochemiluminescence ligand-binding assay (eculizumab). Ravulizumab PK parameters were numerically comparable in both studies; the median time to maximum concentrations ranged from 2·3 to 2·8 and 2·3 to 2·6 h in studies 301 and 302, respectively. Ravulizumab steady-state serum concentrations were achieved immediately after the first dose and sustained throughout treatment. For ravulizumab, the mean (SD) post hoc terminal elimination half-life was 49·7 (8·9) days. Serum free C5 concentrations <0·5 µg/ml were achieved after the first ravulizumab dose and sustained throughout treatment in both studies. In a minority of patients, free C5 concentrations <0·5 µg/ml were not consistently achieved with eculizumab in either study. Ravulizumab q8w was more consistent in providing immediate, complete, sustained C5 inhibition than eculizumab every-2-weeks in patients with PNH.",2020,Serum free C5 concentrations <0·5 ,"['Study 302) adult patients with paroxysmal nocturnal haemoglobinuria (PNH', 'adults with paroxysmal nocturnal haemoglobinuria', 'patients with PNH']","['eculizumab-experienced ', 'ravulizumab and eculizumab', 'Ravulizumab']","['median time to maximum concentrations', 'Serum free C5 concentrations <0·5', 'Ravulizumab PK parameters', 'free C5 concentrations <0·5', 'Ravulizumab steady-state serum concentrations']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024790', 'cui_str': 'Paroxysmal nocturnal hemoglobinuria'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",302.0,0.0288987,Serum free C5 concentrations <0·5 ,"[{'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Peffault de Latour', 'Affiliation': 'French Reference Center for Aplastic Anemia and PNH Hematology-Bone Marrow Transplantation, Hôpital Saint-Louis AP-HP, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Brodsky', 'Affiliation': 'Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ortiz', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Risitano', 'Affiliation': 'Hematology, Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Jun H', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Department of Haematology, St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Kulagin', 'Affiliation': 'Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Kulasekararaj', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital, NIHR/Wellcome King's Clinical Research Facility, London, UK.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Rottinghaus', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Aguzzi', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Wells', 'Affiliation': 'Division of Medical Oncology and Haematology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': 'Clinical Haematology at Peter MacCallum Cancer Centre, The Royal Melbourne Hospital and University of Melbourne, Melbourne, Australia.'}]",British journal of haematology,['10.1111/bjh.16711']
2411,32449213,"Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.","OBJECTIVE


To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT 1F  ) receptor agonist developed for the acute treatment of migraine, on simulated driving.
METHODS


Healthy adult volunteers enrolled in two randomized, placebo and active comparator-controlled, crossover studies. Study 1 (N = 90) tested lasmiditan (50-, 100-, 200-mg), alprazolam (1-mg), and placebo at 1.5 hr post-dose. Study 2 (N = 68) tested lasmiditan (100-, 200-mg), diphenhydramine (50-mg, administered 2 hr pre-assessments), and placebo at 8, 12 and 24 hr post-dose. Driving performance was assessed using a validated driving simulator employing a 100 km driving scenario. Standard deviation of lateral position (SDLP), a measure of lane position control, was the primary endpoint.
RESULTS


Assay sensitivity was confirmed by increased SDLP for active comparators at 1.5- and 8-hr time points. Lasmiditan doses showed significant driving impairment versus placebo at 1.5 hr post-dose. Lasmiditan doses were non-inferior to placebo at 8 hr. Driving impairment was concentration-dependent at 1.5 hr but not at 8 hr. Common adverse events were central nervous system-related and mild-to-moderate in severity.
CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",2020,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",['Healthy adult volunteers enrolled in two randomized'],"['lasmiditan', 'lasmiditan ', 'alprazolam (1-mg), and placebo', 'lasmiditan (100-, 200-mg), diphenhydramine', 'placebo']","['Driving performance', 'simulated driving performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]",,0.377978,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Wilbraham', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ellen B', 'Initials': 'EB', 'LastName': 'Dennehy', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Berg', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}]",Human psychopharmacology,['10.1002/hup.2732']
2412,32449228,"Internet-Based Intervention for Postpartum Depression in China (""Mommy go""): Protocol for a Randomized Controlled Trial.","AIM


The purpose of this study is to design a research protocol for the clinical testing of the ""Mommy go"" for pregnant women with a risk of postpartum depression.
DESIGN


A non-blinded randomized controlled trial.
METHODS


A randomized controlled study will be performed from January 2018 to the completion of the study. The intervention group will follow the ""Mommy go"" protocol and the control group will receive traditional support. We will use the Edinburgh Postpartum Depression Scale and the Chinese version of the Postpartum Depression Predictors Inventory-Revised to measure the risk of postpartum depression in pregnant women. The outcomes are clinical data, postpartum depressive mood, self-efficacy and infant temperament. Outcomes will be assessed using questionnaires and through data generated by digital technologies.
DISCUSSION


The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression. We expect the study to have a clinical impact on future online interventions for postpartum depression in China.
IMPACT


This study will provide an internet-based intervention for postpartum depression in China. It will be implemented in clinical practice if it can effectively improve postpartum depression.",2020,"The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression.","['postpartum depression in China', 'pregnant women with a risk of postpartum depression', 'pregnant women']","['Mommy go"" protocol and the control group will receive traditional support', 'Internet-Based Intervention']","['clinical data, postpartum depressive mood, self-efficacy and infant temperament', 'self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",,0.155209,"The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression.","[{'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Anhui Medical University, Feicui Road,Jingkai District, Hefei, Anhui province, 230032, P.R.China.'}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Mu', 'Affiliation': 'Teaching assistant and Registered Nurse, (TING-YU MU), Anhui Medical University, Feicui Road,Jingkai District, Hefei, Anhui province, 230032, P.R.China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Anhui Medical University, Feicui Road,Jingkai District, Hefei, Anhui province, 230032, P.R.China.'}, {'ForeName': 'Cheng-Lu', 'Initials': 'CL', 'LastName': 'Zhang', 'Affiliation': 'Anhui Medical University, Feicui Road,Jingkai District, Hefei, Anhui province, 230032, P.R.China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'the Second Affiliated Hospital of Anhui Medical University, Anhui Hefei, 230022, China.'}, {'ForeName': 'Jin-Ju', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'the Second Affiliated Hospital of Anhui Medical University, Anhui Hefei, 230022, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'the Second Affiliated Hospital of Anhui Medical University, Anhui Hefei, 230022, China.'}]",Journal of advanced nursing,['10.1111/jan.14436']
2413,32449277,Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation.,"BACKGROUND


Constipated patients remain dissatisfied with current treatments suggesting a need for alternative therapies.
AIM


Evaluate the mechanistic effects of oral vibrating capsule in chronic idiopathic constipation (CIC) by examining the temporal relationships between the onset of vibrations, complete spontaneous bowel movements (CSBM), and circadian rhythm.
METHODS


In post hoc analyses of two double-blind studies, CIC patients (Rome III) were randomized to receive 5 active or sham capsules/week for 8 weeks. The capsules were programmed for single vibration (study 1) or two vibration sessions with two modes, 8 hours apart (study 2). Daily electronic diaries assessed stool habit and percentage of CSBMs associated with vibrations. Responders were patients with ≥ 1 CSBM per week over baseline.
RESULTS


250 patients were enrolled (active = 133, sham = 117). During and within 3 hours of vibration, there were significantly more % CSBMs in the active vs. sham group (50% vs. 42%; P = .0018). In study 2, there were two CSBM peaks associated with vibration sessions. Significantly more % CSBMs occurred in active mode 1 (21.5%) vs. sham (11.5%); (P = .0357). Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75). Device was well-tolerated barring mild vibration sensation.
CONCLUSIONS


Vibrating capsule may increase CSBMs possibly by enhancing the physiologic effects of waking and meals, and augmenting circadian rhythm, although responder rate was not different from sham. Two vibration sessions were associated with more CSBMs.",2020,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","['250 patients were enrolled (active\xa0=\xa0133, sham\xa0=\xa0117', 'CIC patients (Rome III', 'chronic idiopathic constipation', 'chronic idiopathic constipation (CIC']","['oral vibrating capsule', 'vibrating capsule']","['Responder rates', 'CSBMs', 'Daily electronic diaries assessed stool habit and percentage of CSBMs', 'colonic circadian rhythm and bowel symptoms']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",250.0,0.356394,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Augusta University Medical Center, Augusta, GA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Friedenberg', 'Affiliation': 'Great Lakes Gastroenterology Research, Mentor, OH, USA.'}, {'ForeName': 'Eamonn M M', 'Initials': 'EMM', 'LastName': 'Quigley', 'Affiliation': 'Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital, Weill Cornell Medical College, Houston, TX, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13890']
2414,32446298,Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial.,"BACKGROUND


Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear.
METHODS/DESIGN


The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis.
DISCUSSION


DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03778554. Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42, registered on 28 September 2018.",2020,"The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure.","['patients without reduced LVEF or heart failure', '3570 patients', 'post-MI patients in the absence of reduced LVEF or heart failure', 'trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤\u200940', 'after myocardial infarction without reduced ejection fraction', '2018-002699-42, registered on 28 September 2018', 'patients without heart failure and reduced LVEF']","['beta-blocker treatment', 'beta-blocker', 'beta-blockers', 'long-term beta-blocker therapy']","['cardiovascular mortality', 'mortality and morbidity', 'composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3570.0,0.267334,"The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure.","[{'ForeName': 'Anna Meta Dyrvig', 'Initials': 'AMD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. anna.meta.dyrvig.kristensen.02@regionh.dk.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bovin', 'Affiliation': 'Department of Cardiology, Sygehus Lillebælt, Vejle, Denmark.'}, {'ForeName': 'Ann Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'Danish Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cerquira', 'Affiliation': 'The Regional Clinical Quality Development Program, Aarhus, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristian Korsgaard', 'Initials': 'KK', 'LastName': 'Thomsen', 'Affiliation': 'Department of Cardiology, Sydvestjysk Sygehus, Esbjerg, Denmark.'}, {'ForeName': 'Michael Hecht', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Department of Internal Medicine, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Mogens Lytken', 'Initials': 'ML', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Olav Wendelboe', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Cardiology, Frederiksberg Heart Clinic, Copenhagen, Denmark.'}, {'ForeName': 'Sussie', 'Initials': 'S', 'LastName': 'Foghmar', 'Affiliation': 'Department of Cardiology, Hvidovre-Amager Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sehested', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of Clinical Sciences, Division of Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atar', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibanez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC) & IIS- Fundación Jiménez Díaz & CIBERCV, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-4214-6']
2415,32446304,Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial.,"BACKGROUND


Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure.
METHODS


This study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15 mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15 mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences.
RESULTS


Cumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p = < 0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p = < 0.001, < 0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups.
CONCLUSION


Benzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure.
TRIAL REGISTRATION


Study was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.",2020,"Complaints of nausea and vomiting were comparable in both groups.
","['endoscopic retrograde cholangiopancreatography procedure', 'A total of 72 subjects', 'patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018']","['Benzydamine hydrochloride', '15\u2009mL of 0.15% benzydamine hydrochloride', 'propofol', 'propofol and topical analgesic', 'Endoscopic Retrograde Cholangiopancreatography (ERCP', 'benzydamine hydrochloride', 'Propofol', '15\u2009mL of water mouthwash', 'benzydamine hydrochloride gargle']","['Incidence of desaturation, postoperative nausea vomitting, and dysphagia', 'Cumulative propofol consumption per minute per kg body weight', 'cumulative propofol consumption', 'Desaturation', 'Complaints of nausea and vomiting', 'Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat', 'propofol consumption', 'incidence of sore throat']","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282070', 'cui_str': 'Benzydamine hydrochloride'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",72.0,0.100761,"Complaints of nausea and vomiting were comparable in both groups.
","[{'ForeName': 'Adhrie', 'Initials': 'A', 'LastName': 'Sugiarto', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia. adhrie@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kapuangan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Aida Rosita', 'Initials': 'AR', 'LastName': 'Tantri', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chrisnata', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}]",BMC anesthesiology,['10.1186/s12871-020-00996-x']
2416,32446306,Fenofibrate decreased microalbuminuria in the type 2 diabetes patients with hypertriglyceridemia.,"BACKGROUND


This study was to research the efficacy of fenofibrate in the treatment of microalbuminuria in the patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia.
METHODS


Type 2 diabetic patients (56) with microalbuminuria and hypertriglyceridemia aged 30 to 75 were randomly divided into the fenofibrate treatment group(n = 28) and the control group (n = 28) for 180 days. Urinary microalbumin /creatinine ratio (UACR) and other metabolic parameters were compared at baseline, during treatment and after treatment.
RESULTS


After 180 days, the reduction of level of fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) between two groups showed no difference. In the treatment group, uric acid (UA) (296.42 ± 56.41 vs 372.46 ± 72.78), triglyceride (TG) [1.51(1.17, 2.06) vs 3.04(2.21, 3.29)], and UACR [36.45 (15.78,102.41) vs 129.00 (53.00, 226.25)] were significantly decreased compared with the baseline. The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline. The decrease in UACR [- 44.05(- 179.47, - 12.16) vs - 8.15(- 59.69, 41.94)]in treatment group was significantly higher compared with the control group. The decrease in UACR was positively associated with the decreases in TG (r = 0.447, P = 0.042) and UA (r = 0.478, P = 0.024) after fenofibrate treatment.
CONCLUSION


In the patients with hypertriglyceridemia and type 2 diabetes mellitus, fenofibrate can improve microalbuminuria and do not increase the deterioration of glomerular filtration rate.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02314533, 2014.12.9.",2020,The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline.,"['Type 2 diabetic patients (56) with microalbuminuria and hypertriglyceridemia aged 30 to 75', 'patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia', 'patients with hypertriglyceridemia and type 2 diabetes mellitus', 'type 2 diabetes patients with hypertriglyceridemia']","['Fenofibrate', 'fenofibrate', 'fenofibrate treatment group(n\u2009=\u200928) and the control group']","['uric acid (UA', 'microalbuminuria', 'UACR', 'triglyceride (TG', 'deterioration of glomerular filtration rate', 'TG', 'reduction of level of fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c', 'high-density lipoprotein cholesterol (HDL-C) levels', 'Urinary microalbumin /creatinine ratio (UACR) and other metabolic parameters']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.031251,The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline.,"[{'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China. drwg6688@126.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01254-2']
2417,32446311,Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


Efficacy of conventional treatment plus the complementary therapy Liu-zi-jue (a mind-body exercise) to treat patients with mild COVID-19.
TRIAL DESIGN


The study is a single-center 2 arm, randomized controlled trial with parallel-group design.",2020,"OBJECTIVES


Efficacy of conventional treatment plus the complementary therapy Liu-zi-jue (a mind-body exercise) to treat patients with mild COVID-19.
","['patients with mild COVID-19', 'Patients with 2019 Novel Coronavirus Pneumonia (COVID-19']","['conventional treatment plus the complementary therapy Liu-zi-jue (a mind-body exercise', 'Liu-zi-jue']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0936077', 'cui_str': 'Complementary therapy'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.194031,"OBJECTIVES


Efficacy of conventional treatment plus the complementary therapy Liu-zi-jue (a mind-body exercise) to treat patients with mild COVID-19.
","[{'ForeName': 'Shuaipan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Tuina Department, Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Zhizhen', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Tuina Department, Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qingguang', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Institute of Tuina, Shanghai Institute of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Wuquan', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Tuina Department, Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Institute of Tuina, Shanghai Institute of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Tuina Department, Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Tuina Department, Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. fangmin19650510@163.com.'}]",Trials,['10.1186/s13063-020-04383-2']
2418,32446675,"Influence of the Instructional Approach ""Mastery Learning"" versus ""See One, Do One"" on Acquiring Competencies in Abdomen Sonography: A Comparative Effectiveness Analysis.","Ultrasound is an important diagnostic tool in patients with abdominal pain and after injury. However, it is highly dependent on the skills and training of the examiner. Thus, ultrasound competencies should be acquired early during medical education. The instructional approach affects the retention and performance of skills. A promising approach is ""mastery learning."" The aim of the study was to evaluate the effectiveness of ""mastery learning"" compared with the ""see one, do one"" approach by performing a focused assessment of sonography for trauma (FAST) in undergraduate medical students based using an academic assessment tool (Objective Structured Clinical Examination [OSCE]). In a prospective controlled trial, 146 participants were randomly allocated to two groups (see one, do one and mastery learning) and trained in a 90-min module. In the see one, do one group, the trainer demonstrated the complete FAST routine, and then the students trained each other on it under supervision and received direct oral feedback from the tutors. In the mastery learning group, each student received a routing slip. The routing slip contained five levels of competence for the FAST routine, each of which had to be achieved (e.g., choosing the correct probe) and verified by the trainer before working toward the next competency level. The acquired competencies were assessed after training using the OSCE, which is a standardized practical exam using checklists. The mastery learning group attained 40.69 ± 5.6 points on average (of a maximum of 46 points), and the see one, do one group, 33.85 ± 7.7 points (p < 0.001). Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.",2020,"Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.","['patients with abdominal pain and after injury', '146 participants', 'undergraduate medical students', 'Abdomen Sonography']","['Mastery learning', 'mastery learning']",['retention and performance of skills'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",146.0,0.0211243,"Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Britz', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Voß', 'Affiliation': 'MVZ Voss, Aschaffenburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Carstensen', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Germanyuk', 'Affiliation': 'Department of Urology and Pediatric Urology, University of Saarland, Homburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ruesseler', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: miriam.ruesseler@kgu.de.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.04.001']
2419,32446706,A role for the right dorsolateral prefrontal cortex in enhancing regulation of both craving and negative emotions in internet gaming disorder: A randomized trial.,"Reward-seeking and relief from negative emotions are two central motivational drives underlying addictions. Impaired executive control over craving and negative emotions contributes to compulsive addictive behaviors. Neuroimaging evidence has implicated the prefrontal cortex (PFC) in regulating craving or emotions. This study aims at examining whether anodal transcranial direct current stimulation (tDCS) over a specific region of the PFC would enhance both regulation processes. Thirty-three men with internet gaming disorder received active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC) one week apart in a randomized order. During each stimulation session, participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal. Subjective ratings of craving and negative emotions and skin conductance responses (SCRs) were recorded. For both craving and negative emotions, tDCS of the right dlPFC facilitated downregulation and upregulation: active relative to sham tDCS decreased ratings (ROC: 95% CI of difference -1.38 to -0.56, p < 0.001; ER: -1.65 to -0.70, p < 0.001) and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation. These findings provide the first experimental evidence confirming that tDCS of the right dlPFC enhances both craving- and negative-emotion-regulation. This suggests a promising approach for concurrently enhancing executive control over two central motivational drives underlying addictions.",2020,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","['Thirty-three men with internet gaming disorder received', 'internet gaming disorder']","['participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal', 'anodal transcranial direct current stimulation (tDCS', 'active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC']",['Subjective ratings of craving and negative emotions and skin conductance responses (SCRs'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",33.0,0.110968,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA; Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Mental Health Center, New Haven, CT, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Faculty of Education, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Department of Psychology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Yip', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jia-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China; Beijing Key Lab of Applied Experimental Psychology, School of Psychology, Beijing Normal University, Beijing, China. Electronic address: zhangjintao@bnu.edu.cn.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.04.003']
2420,32446752,Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT.,"INTRODUCTION


Internet-delivered behavioral weight control is promising for expanding the reach and availability of weight management, but online programs produce lower weight losses than typically achieved in person. Financial incentives have been shown to increase weight losses. This study examined whether adding financial incentives for self-monitoring and achieving target weight losses increases weight losses attained in a fully online, group-based behavioral weight management program compared with the same program alone.
STUDY DESIGN


This study was an RCT.
SETTING/PARTICIPANTS


Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers.
INTERVENTION


The intervention was a 24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet + incentives).
MAIN OUTCOME MEASURES


This study measured weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity). Data were collected between February 2016 and August 2018, and analyses were completed in 2019.
RESULTS


Participants randomized to the Internet + incentives group lost more weight (-6.4 [SD=5.5] kg) than those in the Internet-only group (-4.7 [SD=6.6] kg; p<0.01). Further, a higher proportion of the Internet + incentives group achieved ≥5% weight loss (55%) than those in the Internet-only group (40%; p<0.05). Treatment engagement was higher in the Internet + incentives condition, with greater self-monitoring of behaviors targeted by incentives, as well as higher rates of behaviors not targeted and higher self-reported physical activity. Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
CONCLUSIONS


Adding financial incentives to a program delivered fully online increases weight losses compared with the program alone and can achieve weight losses comparable to in-person programs, offering potential for substantial geographic reach.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02688621.",2020,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","['Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers', 'Data were collected between February 2016 and August 2018, and analyses were completed in 2019']",['24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet\u202f+\u202fincentives'],"['weight', 'Study retention', 'weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity', 'weight losses', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0376283,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","[{'ForeName': 'Delia S', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. Electronic address: westds@mailbox.sc.edu.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, Tennessee.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School and Duke University Global Health Institute, Singapore and Durham, North Carolina.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Stansbury', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Doris E', 'Initials': 'DE', 'LastName': 'Ogden', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Monroe', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Chelsea A', 'Initials': 'CA', 'LastName': 'Carpenter', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Naud', 'Affiliation': 'Biomedical Statistics, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jean R', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.015']
2421,32446770,Using Self-Reported Measures of Confidence and Anxiety to Determine the Efficacy of the Surgical Exploration And Discovery (SEAD) Program in Reducing Anxiety and Increasing Confidence in Performing Procedural Skills.,"OBJECTIVE


Clerkship students feel increased anxiety and lack of confidence when it comes to surgery. This study assessed whether participation in Surgical Exploration And Discovery (SEAD), a 2-week intensive surgical program that includes career information, simulation workshops, and operating room observerships, would help decrease anxiety, increase confidence, and foster interest in a surgical career.
SETTING


This study took place at The Ottawa Hospital in Ottawa, Ontario, Canada.
DESIGN


Thirty first year medical students were randomly selected for the SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control. At baseline and after the completion of SEAD, both groups were given a survey containing the State Trait Anxiety Inventory that measures self-reported anxiety levels with an adjunct that gauges confidence and interest in a surgical career.
RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001). However, there was no difference in the average state anxiety with procedural skills (p-value = 0.190) between students who participated in SEAD and those who did not. Students who completed SEAD had a notable increase in their interest in pursuing a career in surgery compared with their pretest (p-value = 0.020) and compared with the control group (p-value = 0.600).
CONCLUSIONS


The SEAD program may increase medical students' confidence and interest in pursuing a surgical career. These results encourage offering medical students with similar opportunities that provide exposure to surgery in preclerkship.",2020,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","['Thirty first year medical students', 'place at The Ottawa Hospital in Ottawa, Ontario, Canada']","['Surgical Exploration And Discovery (SEAD', 'Surgical Exploration And Discovery (SEAD) Program', ""SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control""]","['surgical assisting', 'maintaining sterility', 'State Trait Anxiety Inventory that measures self-reported anxiety levels', 'self-perceived knowledge and confidence for each surgical skill: scrubbing', 'average state anxiety with procedural skills']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184899', 'cui_str': 'Exploratory incision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0163054,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","[{'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Market', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mmark030@uottawa.ca.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Battaglia', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: fbatt066@uottawa.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Langlois', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: elang086@uottawa.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jshin059@uottawa.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Seabrook', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brandys', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.010']
2422,32462992,Predictors of involuntary and voluntary emotional episodic memories of virtual reality scenarios in Veterans with and without PTSD.,"This study investigated predictors of involuntary and voluntary memories of stressful virtual reality scenarios. Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments. They were randomly assigned to a Recounting (16) or a Suppression (16) condition. After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios. One week later, participants completed surprise voluntary memory tests and another thought suppression task. The best predictors of voluntary memory were verbal memory ability, dissociation, and to a lesser extent, physiological arousal before and after scenarios. Dissociation and physiological stress responses selectively affected memory for neutral elements. Higher distress during scenarios impaired voluntary memory but increased the frequency of involuntary memories. Physiological stress responses promoted more frequent involuntary memories immediately after the scenarios. More frequent initial involuntary memories, tonic physiological arousal, and stronger emotional responses to dangerous events predicted difficulty inhibiting involuntary memories at follow-up. The effects of thought suppression were transient and weaker than those of other variables. The findings suggest that posttraumatic amnesia and involuntary memories of adverse events are more related to memory ability and emotional and physiological stress responses than to post-exposure suppression.",2020,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","['Veterans with and without PTSD', 'Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments']",['surprise voluntary memory tests and another thought suppression task'],"['initial involuntary memories, tonic physiological arousal, and stronger emotional responses', 'frequency of involuntary memories', 'memory ability and emotional and physiological stress responses']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0376439', 'cui_str': 'Persian Gulf'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}]",,0.0230765,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","[{'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Szkodny', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Altemus', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Silbersweig', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}]","Memory (Hove, England)",['10.1080/09658211.2020.1770289']
2423,32463014,"A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial.","BACKGROUND


Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
OBJECTIVE


The aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being.
METHODS


The intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test.
RESULTS


The project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020.
CONCLUSIONS


If this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17078.",2020,"Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
","['Young Adult Cancer Survivors (EMPOWER', 'Adolescent and young adult cancer survivors']","['Web-based positive emotion skills intervention', 'Positive Emotion Skills Intervention']","['feasibility, acceptability, retention, and adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.173621,"Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Salsman', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'McLouth', 'Affiliation': 'Department of Behavioral Science, Markey Cancer Center, University of Kentucky College of Medicine, Lexington, KY, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Sorkin', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",JMIR research protocols,['10.2196/17078']
2424,32463117,KATP channels modulate cerebral blood flow and oxygen delivery during isocapnic hypoxia in humans.,"KEY POINTS


ATP-sensitive K +  (KATP) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We then tested whether KATP channels blockade affects the increase in human cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia. Hypoxia-induced increases in the anterior circulation and total cerebral perfusion were attenuated under KATP channels blockade affecting the relative changes of brain oxygen delivery. Therefore, in humans, KATP channels activation modulates the vascular tone in the anterior circulation of the brain, contributing to CBF and CDO 2  responses to hypoxia.
ABSTRACT


ATP-sensitive K +  (KATP) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We then tested whether KATP channels blockade affects the increase in cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia in humans. Nine healthy men were exposed to 5-min trials of normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3 h after glibenclamide ingestion (AGB). Mean arterial pressure (MAP), arterial saturation (SaO 2  ), oxygen (PaO 2  ) and carbon dioxide (PaCO 2  ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2  were quantified during the trials. IHX provoked similar reductions in SaO 2  and PaO 2  , while MAP was not affected by oxygen desaturation or KATP blockade. A smaller increase in ICABF (ΔBGB: 36 ± 23 vs. ΔAGB 11 ± 18%, p = 0.019) but not in VABF (∆BGB 26 ± 21 vs. ∆AGB 27 ± 27%, p = 0.893) was observed during the hypoxic trial under KATP channels blockade. Thus, IHX-induced increases in tCBF (∆BGB 32 ± 19 vs. ∆AGB 14 ± 13%, p = 0.012) and CDO 2  relative changes (∆BGB 7 ± 13 vs. ∆AGB -6 ± 14%, p = 0.048) were attenuated during AGB hypoxic trial. In a separate protocol, 6 healthy men (5 from protocol 1) underwent 5-min exposure to normoxia and IHX before and 3 h after placebo (5 mg of cornstarch) ingestion. IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses. Therefore, in humans, KATP activation modulates vascular tone in the anterior rather than the posterior circulation of the brain, contributing to tCBF and CDO 2  responses to hypoxia. This article is protected by copyright. All rights reserved.",2020,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","['6\xa0healthy men (5 from protocol 1) underwent', 'Nine healthy men', 'humans']","['normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3\xa0h after glibenclamide ingestion (AGB', 'IHX', 'KATP channels blockade', '5-min exposure to normoxia and IHX before and 3\xa0h after placebo (5\xa0mg of cornstarch) ingestion', 'KATP channels', 'placebo']","['anterior circulation and total cerebral perfusion', 'ICABF', 'human cerebral blood flow (CBF', 'tCBF', 'Mean arterial pressure (MAP), arterial saturation (SaO 2  ), oxygen (PaO 2  ) and carbon dioxide (PaCO 2  ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2', 'cerebral blood flow (CBF', 'cerebral blood flow and oxygen delivery', 'ICABF, VABF, tCBF, or CDO 2  responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}]",9.0,0.0504265,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","[{'ForeName': 'Marcos P', 'Initials': 'MP', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'Mattos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Mansur', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, The Copenhagen Muscle Research Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Antonio C L', 'Initials': 'ACL', 'LastName': 'Nóbrega', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroVASQ-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brazil.'}]",The Journal of physiology,['10.1113/JP279751']
2425,32463140,Efficacy and safety of three times daily dosing of tacrolimus in pediatric kidney transplantation patients: A single-center comparative study.,"BACKGROUND/AIM


Several PK studies have shown that most pediatric patients may require higher doses on a mg/kg basis compared to adults to attain similar therapeutic trough concentrations. The aim of this study was to compare the efficacy and safety of three times daily to twice a day dosing of tacrolimus in pediatric kidney transplant recipients at a major tertiary care transplant center.
METHODS AND MATERIALS


Retrospective, single-center, and comparative cohort study. All pediatric kidney transplant recipients received either tacrolimus BID (group 1) or tacrolimus TID (group 2).
RESULTS


A total of 87 patients were included in this study; 48 patients received BID tacrolimus (group 1), and 39 patients received TID tacrolimus (group 2). The percentage of patients who achieved therapeutic trough concentrations in group 2 did not significantly differ from those in group 1 at day 7 (84.62% TID vs 83.33% BID; P = .42). The median time to reach therapeutic trough concentrations was three days in group 1 compared to four days in group 2.
CONCLUSION


No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.",2020,No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.,"['87 patients were included in this study; 48 patients received', 'pediatric kidney transplantation patients', 'pediatric kidney transplant recipients at a major tertiary care transplant center', 'All pediatric kidney transplant recipients']","['tacrolimus TID', 'tacrolimus BID', 'BID tacrolimus', 'TID tacrolimus', 'tacrolimus']","['efficacy and safety', 'percentage of patients who achieved therapeutic trough concentrations', 'Efficacy and safety', 'median time to reach therapeutic trough concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",87.0,0.0266428,No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.,"[{'ForeName': 'Zinah', 'Initials': 'Z', 'LastName': 'Alabdulkarim', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Jedai', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Delal', 'Initials': 'D', 'LastName': 'Alkortas', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alhasan', 'Affiliation': 'Kidney & Pancreas Transplantation Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Devol', 'Affiliation': 'Biostatistics Epidemiology & Scientific Computing Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}]",Pediatric transplantation,['10.1111/petr.13733']
2426,32463163,Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.,"BACKGROUND


Many patients develop seroma after laparoscopic ventral hernia repair. It was hypothesized that leaving the hernial sac in situ may cause this complication.
METHODS


In this patient- and outcome assessor-blinded, parallel-design single-centre trial, patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair were randomized (1 : 1) to either conventional fascial closure or peritoneal bridging. The primary endpoint was the incidence of seroma 12 months after index surgery detected by CT, evaluated in an intention-to-treat analysis.
RESULTS


Between September 2017 and May 2018, 62 patients were assessed for eligibility, of whom 25 were randomized to conventional closure and 25 to peritoneal bridging. At 3 months, one patient was lost to follow-up in the conventional and peritoneal bridging groups respectively. No seroma was detected at 6 or 12 months in either group. The prevalence of clinical seroma was four of 25 (16 (95 per cent c.i. 2 to 30) per cent) versus none of 25 patients in the conventional fascial closure and peritoneal bridging groups respectively at 1 month after surgery (P = 0·110), and two of 24 (8 (0 to 19) per cent) versus none of 25 at 3 months (P = 0·235). There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
CONCLUSION


Conventional fascial closure and peritoneal bridging did not differ with regard to seroma formation after laparoscopic ventral hernia repair.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03344575).",2020,"There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
","['patients develop seroma after laparoscopic ventral hernia repair', 'patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair', '62 patients were assessed for eligibility, of whom 25 were randomized to', 'Between September 2017 and May 2018']","['conventional closure and 25 to peritoneal bridging', 'laparoscopic intraperitoneal onlay ventral hernia mesh repair', 'Peritoneal bridging versus fascial closure', 'Conventional fascial closure and peritoneal bridging', 'conventional fascial closure or peritoneal bridging']","['rate of recurrent hernia', 'postoperative pain', 'prevalence of clinical seroma', 'seroma formation', 'postoperative complications', 'No seroma', 'incidence of seroma 12\u2009months after index surgery detected by CT, evaluated in an intention-to-treat analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",62.0,0.371909,"There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Departments of Surgery, Örebro University Hospital, School of Medical Sciences, Örebro University, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wallin', 'Affiliation': 'Departments of Surgery, Örebro University Hospital, School of Medical Sciences, Örebro University, Stockholm, Sweden.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fathalla', 'Affiliation': 'Emergency Department, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sandblom', 'Affiliation': 'Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",BJS open,['10.1002/bjs5.50305']
2427,32463279,The effects of inhaled flavors on intravenous nicotine.,"Menthol is the only available flavor in combusted tobacco cigarettes; however, e-cigarettes are available in thousands of flavors. Research on flavors and rewarding properties of nicotine is limited. The present study sought to examine the acute rewarding effects of flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine among cigarette smokers. In the present study, 24 menthol-preferring young adult (aged 18 to 30) cigarette smokers were tested under 3 different e-cigarette flavor conditions (menthol, green apple, or menthol + green apple) in a within-subject cross-over design. During each test session, each participant received 3 IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine) administered 1 hr apart. The main outcome measures assessed cardiovascular, subjective, and cognitive domains. Compared with green apple or green apple + menthol, menthol produced higher ratings of ""cooling"" ( p s < 0.01). Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05). As expected, IV-nicotine dose-dependently increased the ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges (all  p s < 0.05). These subjective, cognitive, and physiological effects of nicotine were not affected by any flavor condition. The present findings did not support an interaction between IV-nicotine dose and inhaled flavor for acute effects of nicotine. Green apple flavor, alone or in combination with menthol, could result in higher craving or insufficiently alleviate craving, relative to menthol flavor alone. Additional research is warranted to examine extended exposure to inhaled flavors on the rewarding and addictive effects of nicotine. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"['cigarette smokers', '24 menthol-preferring young adult (aged 18 to 30) cigarette smokers']","['IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine', 'Green apple flavor, alone or in combination with menthol', 'cigarette flavor conditions (menthol, green apple, or menthol + green apple', 'Menthol', 'inhaled flavors', 'nicotine', 'flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine', 'green apple or green apple + menthol, menthol']","['cardiovascular, subjective, and cognitive domains', 'ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges', 'Craving', 'ratings of ""cooling']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0475653', 'cui_str': 'Apple flavor'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",,0.0245257,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"[{'ForeName': 'R Ross', 'Initials': 'RR', 'LastName': 'MacLean', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'MacKenzie R', 'Initials': 'MR', 'LastName': 'Peltier', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Suprit', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'VA Connecticut Healthcare System.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000394']
2428,32463281,"Impact of smoked cannabis on tobacco cigarette smoking intensity and subjective effects: A placebo-controlled, double-blind, within-subjects human laboratory study.","Co-users of cannabis and tobacco frequently use cannabis, then tobacco cigarettes, in a sequential pattern within an occasion, that is, they ""chase"" smoked cannabis with a tobacco cigarette. The objective of this placebo-controlled, double-blind, within-subjects human laboratory study was to gather preliminary data on how smoking active versus placebo cannabis impacts tobacco cigarette smoking behavior, craving, and subjective effects. Adult daily cannabis and tobacco co-users ( N  = 9) were randomly assigned to two experimental visit orders (i.e., active cannabis (5.2% THC) first visit and placebo cannabis second visit, or vice versa). Participants smoked one cannabis cigarette, and approximately 30 min later were given a 5-min ad libitum period to smoke one of their own brand of tobacco cigarette. As expected, boost in plasma THC levels and cannabis-related subjective effects differed between active and placebo cannabis conditions. Tobacco cigarette puff topography measures and tobacco craving did not differ between cannabis conditions, but there appeared to be between-participants heterogeneity in cumulative total puff volume. After smoking active versus placebo cannabis, the changes in subjective effects of tobacco smoking after adjusting for pretobacco smoking levels were not significant. Results do not support the notion that immediate effects of smoked cannabis change the behavior of tobacco smoking. The strong overlap between cannabis and tobacco smoking may not be explained by primarily pharmacological factors, but may be driven by more nuanced and complex mechanisms involving pharmacological processes as well as learning factors. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"After smoking active versus placebo cannabis, the changes in subjective effects of tobacco smoking after adjusting for pretobacco smoking levels were not significant.",['Adult daily cannabis and tobacco co-users ( N  = 9'],"['smoked cannabis', 'placebo cannabis', 'placebo']","['behavior of tobacco smoking', 'plasma THC levels and cannabis-related subjective effects', 'pretobacco smoking levels', 'tobacco cigarette smoking intensity and subjective effects', 'Tobacco cigarette puff topography measures and tobacco craving']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",9.0,0.19476,"After smoking active versus placebo cannabis, the changes in subjective effects of tobacco smoking after adjusting for pretobacco smoking levels were not significant.","[{'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Peters', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Herrmann', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Carson', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Jess Alan', 'Initials': 'JA', 'LastName': 'Wilhelm', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Koszowski', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Halquist', 'Affiliation': 'Department of Pharmaceutics, Virginia Commonwealth University.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kosmider', 'Affiliation': 'Department of Pharmaceutics, Virginia Commonwealth University.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Poklis', 'Affiliation': 'Department of Pharmacology and Toxicology, Virginia Commonwealth University.'}, {'ForeName': 'Sage', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bart', 'Affiliation': 'Public Health Business Line, Battelle.'}, {'ForeName': 'Wallace B', 'Initials': 'WB', 'LastName': 'Pickworth', 'Affiliation': 'Public Health Business Line, Battelle.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000391']
2429,32463382,Comparison the effects of inhalation and massage aromatherapy with lavender and sweet orange on fatigue in hemodialysis patients: a randomized clinical trial.,"Objectives Fatigue, regardless of the causes, could leave a negative impact on individual performance. The aim of this study was to compare the effects of inhalation and massage aromatherapy with lavender and sweet orange on fatigue among hemodialysis patients. Methods This study was a randomized controlled trial. The patients (96 patients) were allocated to three groups (control, an inhalation aromatherapy, and an aromatherapy massage group). A demographic questionnaire as well as the rhoten fatigue scale (RFS) was used to collect the data. The data were analyzed by descriptive and analytical statistics using SPSS version 18. Results Before the intervention, there was no significant difference among the groups regarding fatigue level (p=0.54). However, eight and 16 weeks after the study, the levels of fatigue in both experimental groups were significantly lower than the control group (p < 0.05). Conclusions Interventions with essential oils are effective in reducing fatigue in hemodialysis patients, although the effects of aromatherapy massage on fatigue are stronger than the effects of inhalation aromatherapy.",2020,"However, eight and 16 weeks after the study, the levels of fatigue in both experimental groups were significantly lower than the control group (p < 0.05).","['hemodialysis patients', 'patients (96 patients']","['inhalation aromatherapy, and an aromatherapy massage', 'inhalation and massage aromatherapy with lavender and sweet orange', 'aromatherapy massage']","['levels of fatigue', 'fatigue level', 'rhoten fatigue scale (RFS']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0522462', 'cui_str': 'Citrus sinensis'}]","[{'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0189684,"However, eight and 16 weeks after the study, the levels of fatigue in both experimental groups were significantly lower than the control group (p < 0.05).","[{'ForeName': 'Shokoh', 'Initials': 'S', 'LastName': 'Varaei', 'Affiliation': 'ِDepartment of Medical Surgical Nursing, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jalalian', 'Affiliation': 'ِDepartment of Medical Surgical Nursing, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekani Nejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Shamsizadeh', 'Affiliation': 'Chronic Diseases (Home Care) Research Center, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, 6517838695, Hamadan, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2018-0137']
2430,32463593,Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects.,"Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUC last  , C max  , and AUC inf  (ratio, 101.41%; 90%CI, 95.49%-107.70%; ratio, 93.55%; 90%CI, 84.15%-104.00%; and ratio, 101.03%; 90%CI, 94.80%-107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. Relative bioavailability of sildenafil citrate ODT administered with water to the sildenafil citrate tablet (50 mg) administered with water was 97.10%, 91.43%, and 97.09% with respect to sildenafil AUC last  , C max  , and AUC inf  , respectively (90%CI, 91.43%-03.12%, 82.25%-101.65%, and 90.90%-103.71%, respectively). Both sildenafil citrate formulations were generally well tolerated in healthy Chinese men. Sildenafil citrate ODT administered without or with water was bioequivalent to or met bioequivalence criteria compared with conventional sildenafil citrate tablets administered with water under fasted conditions in healthy Chinese men, thus offering a convenient alternative method of oral administration.",2020,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"['Healthy Chinese male subjects (n = 36', 'healthy Chinese men', 'Healthy Chinese Male Subjects']","['sildenafil citrate tablet', 'sildenafil citrate ODT', 'Sildenafil citrate ODT', 'conventional sildenafil citrate tablets', 'sildenafil AUC', 'sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets', 'sildenafil citrate formulations', 'Sildenafil citrate', 'sildenafil citrate', 'Sildenafil Citrate', 'sildenafil']","['Relative bioavailability', 'AUC last  , C max  , and AUC inf', 'Bioequivalence and Bioavailability', 'last  , C max  , and AUC inf']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",36.0,0.0744477,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Peking University First Hospital, Institute of Clinical Pharmacology, Beijing, China.'}, {'ForeName': 'Bin-Yu', 'Initials': 'BY', 'LastName': 'Luo', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Pfizer Inc, Beijing, China.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': 'ExecuPharm, King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Penelope H', 'Initials': 'PH', 'LastName': 'Crownover', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Qinying', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.806']
2431,32463599,"A Randomized, Double-Blind, Parallel-Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects.","A comparison of the immunogenicity, safety, and pharmacokinetic properties of HS016 and its originator, adalimumab, was conducted in Chinese healthy male subjects. This was a phase 1 single-center, randomized, parallel-group double-blind clinical trial. Chinese healthy male subjects (1:1) allocated to HS016 and adalimumab groups were treated with single subcutaneous injections (40 mg/0.8 mL). The pharmacokinetic equivalence of HS016 and adalimumab was assessed by (1) the area under the plasma concentration-time curve (AUC) from time 0 to the last detectable drug concentration (AUC 0-t  ), (2) the AUC from time 0 extrapolated to infinity (AUC 0-∞  ), and (3) the maximum plasma concentration (C max  ). Other pharmacokinetic parameters (time to C max  , apparent clearance, and half-life), safety, and immunogenicity were also evaluated. A total of 136 subjects were randomly divided into HS016 (n = 68) or adalimumab (n = 68) groups. The geometric means of AUC 0-t  , AUC 0-∞  , and C max  were similar for HS016 and adalimumab. The 90%CIs of AUC 0-t  (87.2% to 106.1%), AUC 0-∞  (87.4% to 108.4%), and C max  (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%). The incidence of treatment-emergent adverse events (TEAEs) was similar in both groups, with most TEAEs being mild; only 3 (4.4%) subjects in the HS016 group experienced moderate TEAEs. No significant differences in the time to C max  , apparent clearance, half-life, and immunogenicity were detected. The pharmacokinetic profile of HS016 was equivalent to that of the originator, adalimumab, with similar safety and immunogenicity profiles. HS016 may be considered for assessment in the treatment of patients with ankylosing spondylitis.",2020,"The 90%CIs of AUC 0-t  (87.2% to 106.1%), AUC 0-∞  (87.4% to 108.4%), and C max  (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%).","['Chinese healthy male subjects', 'patients with ankylosing spondylitis', 'Chinese Healthy Male Subjects', '136 subjects', 'Chinese healthy male subjects (1:1) allocated to']","['adalimumab', 'Biosimilar HS016 and the Originator Adalimumab', 'HS016 and adalimumab', 'HS016', 'single subcutaneous injections', 'HS016 and its originator, adalimumab']","['time to C max  , apparent clearance, half-life, and immunogenicity', 'maximum plasma concentration (C max  ', 'plasma concentration-time curve (AUC', '90%CIs of AUC 0-t', 'pharmacokinetic parameters (time to C max  , apparent clearance, and half-life), safety, and immunogenicity', 'incidence of treatment-emergent adverse events (TEAEs', 'immunogenicity, safety, and pharmacokinetic properties', 'geometric means of AUC 0-t  , AUC 0-∞  , and C max']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",136.0,0.110923,"The 90%CIs of AUC 0-t  (87.2% to 106.1%), AUC 0-∞  (87.4% to 108.4%), and C max  (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%).","[{'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.816']
2432,32463618,"Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study.","INTRODUCTION


Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period.
METHODS


Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States. Study subjects underwent a trial stimulation lasting up to 14 days with epidural leads implanted from the vertebral levels T4 through T8. Subjects who had ≥40% pain relief during the trial stimulation period were implanted with a Senza system (Nevro Corp., Redwood City, CA) and followed up to 12 months after surgery.
RESULTS


Twenty-three of 24 subjects (95.8%) had a successful trial stimulation and proceeded to a permanent implant. After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores). Secondary outcomes, including assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction, showed that 10-kHz SCS greatly improved the quality of life of patients with CAP. Observationally, most subjects also reported concurrent reduction or resolution of nausea and/or vomiting.
DISCUSSION


10-kHz SCS can provide durable pain relief and improve the quality of life in patients with CAP.",2020,"After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores).","['Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States', 'patients with CAP', 'Twenty-three of 24 subjects (95.8%) had a successful trial stimulation and proceeded to a permanent implant', 'Subjects who had ≥40', 'patients with intractable CAP over a 12-month follow-up period']","['Senza system (Nevro Corp., Redwood City, CA', '10-kHz Spinal Cord Stimulation', '10-kHz spinal cord stimulation (SCS', '10-kHz SCS']","['quality of life', 'assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction', 'pain relief', 'nausea and/or vomiting', 'quality of life of patients with CAP', 'safety and efficacy', 'responders (pain relief', 'durable pain relief']","[{'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1002377', 'cui_str': 'Redwood'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",24.0,0.102048,"After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores).","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': ""Carolina's Pain Institute, Winston-Salem, North Carolina, USA.""}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Kansas Pain Management, Overland Park, Kansas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Paicius', 'Affiliation': 'Newport Beach Headache and Pain, Newport Beach, California, USA.'}, {'ForeName': 'Wyndam', 'Initials': 'W', 'LastName': 'Strodtbeck', 'Affiliation': 'Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vorenkamp', 'Affiliation': 'Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gilmore', 'Affiliation': ""Carolina's Pain Institute, Winston-Salem, North Carolina, USA.""}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Gliner', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rotte', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Province-Azalde', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000133']
2433,32459637,Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation: Randomized Controlled Trial Evaluating Digital Telereview.,"BACKGROUND


<strong>Background</strong>: The benefits of telemedicine include cost savings and decentralized care. Video consultation is one form that enables early detection of deteriorating patients and promotion of self-efficacy in patients who are well but anxious. Abdominal pain is a common symptom presented by patients in emergency departments. These patients could benefit from video consultation, as it enables remote follow-up of patients who do not require admission and facilitates early discharge of patients from overcrowded hospitals.
OBJECTIVE


<strong>Objective</strong>: The study aimed to evaluate the safety and efficacy of the use of digital telereview in patients presenting with undifferentiated acute abdominal pain.
METHODS


<strong>Methods</strong>: This was a prospective randomized controlled trial in which follow-up using existing telephone-based telereview (control) was compared with digital telereview (intervention). Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat. The control arm received routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff. The intervention arm received access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling. Patients were followed-up for 2 weeks for outcomes of service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition).
RESULTS


<strong>Results</strong>: A total of 70 patients participated, with patients randomly assigned to each arm (1:1 ratio). Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56%). The telereview service was used by 32 patients in the control arm (32/35, 91%) and 18 patients in the intervention arm (18/35, 51%). Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition. There was a low rate of re-presentation at 72 hours and 2 weeks for both control (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 2/35, 6%, 95% CI 1.0%-20.5%) and intervention (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 3/35, 9%, 95% CI 2.2%-24.2%) arms. There were no significant differences in safety (<i>P</i>>.99) and efficacy (<i>P</i>>.99) between the two groups.
CONCLUSIONS


<strong>Conclusions</strong>: The application of digital telereview for the follow-up of patients with abdominal pain may be safe and effective. Future studies are needed to evaluate its cost-effectiveness and usefulness for broader clinical application.
CLINICALTRIAL


SingHealth Singapore General Hospital (2017/2049); International Standard Randomized Controlled Trial Number (ISRCTN) 28468556; http://www.controlled-trials.com/ISRCTN28468556/28468556.",2020,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","['strong>Methods</strong', 'CLINICALTRIAL\n\n\nSingHealth Singapore General Hospital (2017/2049', 'patients presenting with undifferentiated acute abdominal pain', 'Patients With Abdominal Pain Using Video Consultation', 'Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56', '70 patients participated', 'Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat']","['existing telephone-based telereview (control', 'digital telereview (intervention', 'digital telereview', 'routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff', 'access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling']","['Safety and Efficacy', 'telereview service', 'safety', 'safety and efficacy', 'low rate of re-presentation', 'Abdominal pain', 'service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition', 'efficacy']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",70.0,0.222931,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","[{'ForeName': 'Dinesh Visva', 'Initials': 'DV', 'LastName': 'Gunasekeran', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Crescent, Outram Rd, S169608, Singapore, SG.'}, {'ForeName': 'Win Jim', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Crescent, Outram Rd, S169608, Singapore, SG.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Crescent, Outram Rd, S169608, Singapore, SG.'}, {'ForeName': 'Chiu Peng', 'Initials': 'CP', 'LastName': 'Cheong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Lay Hong', 'Initials': 'LH', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Chee Siang', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Gaik Kheng', 'Initials': 'GK', 'LastName': 'Phuah', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Newsie Donnah A', 'Initials': 'NDA', 'LastName': 'Manuel', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Che Chong', 'Initials': 'CC', 'LastName': 'Chia', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Gek Siang', 'Initials': 'GS', 'LastName': 'Seng', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'May Hang', 'Initials': 'MH', 'LastName': 'Huin', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Suzette Villaluna', 'Initials': 'SV', 'LastName': 'Dulce', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Yap', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Kishanti', 'Initials': 'K', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Drive, Singapore, SG.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': 'Health Services Research Center (HSRC), Singhealth Services, Singapore, SG.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Crescent, Outram Rd, S169608, Singapore, SG.'}, {'ForeName': 'Ponampalam', 'Initials': 'P', 'LastName': 'R', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, 1 Hospital Crescent, Outram Rd, S169608, Singapore, SG.'}]",Journal of medical Internet research,['10.2196/17417']
2434,32459639,"Optimizing Gestational Weight Gain, Birth Weight and Perinatal Outcomes among Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure: Study Protocol for a Pilot Randomized Controlled Trial.","BACKGROUND


Hypertensive disorders of pregnancy (HDP), including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care (ANC) practices often delay in detecting or miss HDP, which makes the women vulnerable to their adverse consequences. Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management. To undertake a randomized controlled trial (RCT) of this intervention to reduce adverse consequences of HDP raises concerns about its feasibility.
OBJECTIVE


The objectives of this study are to evaluate the accuracy of a wearable BP measuring device (Health Gauge [HG]), to test the design and methods of a future definitive RCT, and to examine the feasibility, acceptability and fidelity of an intervention focusing on regular monitoring of weight gain during pregnancy and self-monitoring of BP among pregnant women at risk of developing HDP or their complications.
METHODS


The study will be conducted in two phases in Matlab, Bangladesh: 1) validation of HG according to the European Society of Hypertension International Protocol revision 2010, and 2) a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. In the pilot trial, 70 eligible participants will be individually randomized 1:1 to the intervention arm in which pregnant women will self-monitor their BP daily using a wearable device (HG) and be evaluated for weight gain monthly from 20 weeks of gestation until delivery or the control arm in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery. All women will receive standard ANC.
RESULTS


A validation study among the general adult population in Matlab has been conducted successfully. The pilot trial has completed enrollment. The follow-up of the participants is ongoing, and results are forthcoming.
CONCLUSIONS


The findings of this study will help us design a comprehensive, full-scale RCT to test the efficacy of a simple and inexpensive intervention such as regular self-monitoring of BP and weight gain during pregnancy aimed at optimizing maternal and fetal outcomes among pregnant women at risk of developing HDP or their complications.
CLINICALTRIAL


ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595.",2020,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","['pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management', 'pregnant women at risk of developing HDP or their complications', 'Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure', 'general adult population in Matlab', 'two phases in Matlab, Bangladesh: 1) validation of HG according to the European Society of Hypertension International Protocol revision 2010, and 2', '70 eligible participants']","['pregnant women will self-monitor their BP daily using a wearable device (HG) and be evaluated for weight gain monthly from 20 weeks of gestation until delivery or the control arm', 'Conventional antenatal care (ANC) practices', 'Regular self-monitoring of blood pressure (BP) and weight gain', 'wearable BP measuring device (Health Gauge [HG']","['weight gain', 'Optimizing Gestational Weight Gain, Birth Weight and Perinatal Outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.125868,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","[{'ForeName': 'S M Tafsir', 'Initials': 'SMT', 'LastName': 'Hasan', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, BD.'}, {'ForeName': 'Syed Imran', 'Initials': 'SI', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, BD.'}, {'ForeName': 'Md Alfazal', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, BD.'}, {'ForeName': 'Shafiqul Alam', 'Initials': 'SA', 'LastName': 'Sarker', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, BD.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, BD.'}]",JMIR research protocols,['10.2196/16676']
2435,32459643,Adherence to Smoking Cessation Treatment and predictors of adherence: Comparing Blended Treatment with Face-To-Face Treatment.,"BACKGROUND


Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator for treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to a blended and a face-to-face smoking cessation treatment, both similar in content and intensity.
OBJECTIVE


The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment (BSCT) with adherence to a face-to-face treatment (F2F); (2) to compare adherence within the blended treatment to its F2F-mode and Web-mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment.
METHODS


We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic, who were randomly assigned either to the blended smoking cessation treatment (BSCT, N=162) or to a face-to-face treatment with identical ingredients (F2F, N=130). For both treatments (BSCT vs. F2F) and for the two modes of delivery within the blended treatment (BSCTs F2F mode vs. BSCTs Web mode), adherence levels (i.e. treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics.
RESULTS


We found no significant difference in adherence between the blended and the face-to-face treatment. BSCT patients spent an average of 246 minutes in treatment (IQR 150-355; 106.7% of intended treatment time); F2F patients spent 238 minutes (IQR 150-330; 103.3%). Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode. BSCT-patients spent an average of 198 minutes in F2F-mode (SD 120; 152% of the intended treatment time) and 75 minutes in Web-mode (SD 53, 75%). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both BSCT and F2F. For F2F, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (BSCT: R2=.049; F2F: R2=.076). Within BSCT, to be living without children predicted higher adherence to BSCTs F2F-mode (R2=.034), independent of age. Higher adherence to BSCTs Web-mode was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting and less health complaints (R2=.164).
CONCLUSIONS


This study has been one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher to the face-to-face mode than the web mode. This supports the idea that in blended treatment one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study, suggests that other variables, such as provider-related health system factors and time-varying patient characteristics should be explored in future research.
CLINICALTRIAL


trialregister.nl NTR5113 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113.",2020,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.",['patients (N=292) of a Dutch outpatient smoking cessation clinic'],"['blended smoking cessation treatment (BSCT, N=162) or to a face-to-face treatment with identical ingredients', 'Blended Treatment with Face-To-Face Treatment', 'BSCT', 'blended smoking cessation treatment (BSCT) with adherence to a face-to-face treatment (F2F']","['adherence', 'adherence levels', 'negative attitude toward quitting and less health complaints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.0203694,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.","[{'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Siemer', 'Affiliation': 'Research Group Technology, Health & Care, Saxion University of Applied Sciences, M.H. Tromplaan 28, Enschede, NL.'}, {'ForeName': 'Marjolein Gj', 'Initials': 'MG', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, NL.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'Postel', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, NL.'}, {'ForeName': 'Somaya', 'Initials': 'S', 'LastName': 'Ben Allouch', 'Affiliation': 'Digital Life Research Group, Amsterdam University of Applied Science, Amsterdam, NL.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Sanderman', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, NL.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Pieterse', 'Affiliation': 'Centre for eHealth and Well-being Research, University of Twente, PO Box 217, Enschede, NL.'}]",Journal of medical Internet research,['10.2196/17207']
2436,32459651,A Randomized Controlled Trial of a Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Feasibility Study.,"BACKGROUND


Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of findings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited.
OBJECTIVE


This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with pre-diabetes.
METHODS


We employed a 2-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the e-DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population, the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity (PA) at 6- and 12-month follow-ups, and secondary outcomes, including change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels.
RESULTS


We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for PA levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up. Mean (SD) intervention group weight (kg) was 92.33 (15.67) baseline, 91.34 (16.04) at 6m, 89.41 (14.93) at 12m. For control group weight (kg) was 92.59 (17.43) baseline 91.71 (16.48) at 6 m, 91.10 (15.82) at 12 m. Mean (SD) intervention group PA (steps) was 7308.40 (4911.93) baseline, 5008.76 (2733.22) at 6 m, 4814.66 (3419.65) at 12 m steps. Control group PA (steps) was 7599.28 (3881.04) baseline, 6148.83 (3433.77) at 6 m, 5006.30 (3681.1) at 12 m.
CONCLUSIONS


This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.
CLINICALTRIAL


ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/ NCT02919397.",2020,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"['people with pre-diabetes', 'People at High Risk of Type 2 Diabetes', 'We enrolled 200 participants: 98', 'people at high risk of developing diabetes', 'Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London']","['smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months', 'Wearable Technology Delivering a Web-Based Diabetes Prevention Program', 'web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP']","['weight', 'PA levels', 'change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels', 'full-scale RCT, namely, change in weight and physical activity (PA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",200.0,0.204808,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Staite', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, Western Education Centre10 Cutcombe Road, London, GB.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, GB.""}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Faculty of Medicine, Department of Medicine & Dasman Diabetes Institute, Kuwait University, Al Kuwayt, KW.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, Western Education Centre10 Cutcombe Road, London, GB.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': ""King's College Hospital NHS Foundation Trust/King's Health Partners, London, GB.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""South Thames Cleft Service, St Thomas' Hospital, London, GB.""}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Basudev', 'Affiliation': 'Health Innovation Network, London, GB.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mohamedali', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, Western Education Centre10 Cutcombe Road, London, GB.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, Western Education Centre10 Cutcombe Road, London, GB.""}]",JMIR mHealth and uHealth,['10.2196/15448']
2437,32459653,The Tailored Adherence Incentives for Childhood Asthma Medications Randomized Trial: A Research Protocol for Children with High-Risk Asthma.,"BACKGROUND


Poor adherence to inhaled corticosteroid (ICS) medications for children with high-risk asthma is a well-documented and poorly understood problem with a disproportionate prevalence and impact on urban minority children. Financial incentives have been shown as a compelling method to engage a high-risk asthma population, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.
OBJECTIVE


To determine the marginal effects of a financial incentive-based ICS adherence intervention on adherence, healthcare system use, and costs in a prospective cohort of child-caregiver dyads.
METHODS


Participants include 125 children aged 5-12 years who have had at least two hospitalizations or one hospitalization and one emergency room visit for asthma in the prior year and their caregivers. All participants have an electronic inhaler sensor that is linked to a smartphone app to track medication use for 7 months. After one month of observation, participants are randomized to one of three possible arms for a 3-month experiment. Participants in arm 1 receive daily text message reminders, feedback, and nominal gain-framed financial incentives; those in arm 2 receive daily text message reminders and feedback only and those in arm 3 receive no reminders, feedback, or incentives. All participants are then observed for an additional 3 months with no reminders, feedback, or incentives to assess for sustained effects.
RESULTS


Study enrollment began in September 2019. Estimated primary completion date is June of 2022 and analyses will be completed by June of 2023.
CONCLUSIONS


The present study will provide data on whether a financial incentive-based mobile-health intervention for promoting ICS use is efficacious in high-risk asthma patients over time.
CLINICALTRIAL


Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410.",2020,"All participants are then observed for an additional 3 months with no reminders, feedback, or incentives to assess for sustained effects.
","['urban minority children', 'Participants include 125 children aged 5-12 years who have had at least two hospitalizations or one hospitalization and one emergency room visit for asthma in the prior year and their caregivers', 'Children with High-Risk Asthma', 'child-caregiver dyads', 'children with high-risk asthma']","['financial incentive-based ICS adherence intervention', 'financial incentive-based mobile-health intervention', 'daily text message reminders, feedback, and nominal gain-framed financial incentives; those in arm 2 receive daily text message reminders and feedback only and those in arm 3 receive no reminders, feedback, or incentives', 'inhaled corticosteroid (ICS) medications']","['adherence, healthcare system use, and costs']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",125.0,0.168191,"All participants are then observed for an additional 3 months with no reminders, feedback, or incentives to assess for sustained effects.
","[{'ForeName': 'Brittney R', 'Initials': 'BR', 'LastName': 'Henderson', 'Affiliation': ""Children's Hospital of Philadelphia, Roberts Center for Pediatric Research, 2716 South St10th floor, Rm 10-293, Philadelphia, US.""}, {'ForeName': 'Carina M', 'Initials': 'CM', 'LastName': 'Flaherty', 'Affiliation': ""Children's Hospital of Philadelphia, Roberts Center for Pediatric Research, 2716 South St10th floor, Rm 10-293, Philadelphia, US.""}, {'ForeName': 'G Chandler', 'Initials': 'GC', 'LastName': 'Floyd', 'Affiliation': ""Children's Hospital of Philadelphia, Roberts Center for Pediatric Research, 2716 South St10th floor, Rm 10-293, Philadelphia, US.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'You', 'Affiliation': ""Children's Hospital of Philadelphia, Roberts Center for Pediatric Research, 2716 South St10th floor, Rm 10-293, Philadelphia, US.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xiao', 'Affiliation': ""Children's Hospital of Philadelphia, 3401 Civic Center BlvdDivision of Neonatology, 2NW35, Philadelphia, US.""}, {'ForeName': 'Tyra C', 'Initials': 'TC', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, 3401 Civic Center BlvdDivision of Neonatology, 2NW35, Philadelphia, US.""}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': ""Children's Hospital of Philadelphia, 3401 Civic Center BlvdDivision of Neonatology, 2NW35, Philadelphia, US.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Feudtner', 'Affiliation': ""Children's Hospital of Philadelphia, 3401 Civic Center BlvdDivision of Neonatology, 2NW35, Philadelphia, US.""}, {'ForeName': 'Chen Collin', 'Initials': 'CC', 'LastName': 'Kenyon', 'Affiliation': ""Children's Hospital of Philadelphia, Roberts Center for Pediatric Research, 2716 South St10th floor, Rm 10-293, Philadelphia, US.""}]",JMIR research protocols,['10.2196/16711']
2438,32459660,Implementing a Wearable Sensor for Lymphedema Garments: A Prospective Study of Training Effectiveness.,"Lymphedema garments apply therapeutic pressure to maintain minimum leg volume. Practitioners and patients apply these garments and seek to achieve appropriate compression pressure ""by feel.""
PURPOSE


A study was conducted to assess the feasibility of applying a sensor-feedback device to train staff to accurately apply garments.
METHODS


A convenience sample of wound care and rehabilitation staff volunteered for a prospective, randomized, unblinded, single-center pilot study. Participants were randomized to instruction+feedback (ie, receiving training on compression application and using the device to determine whether they achieved desired pressure) or instruction only groups (n = 6 each). Each volunteer applied hook-and-loop closures on the author's leg pre- and post-training with a target of 35 mm Hg, or |Ppre- 35|= |Ppost- 35|=0. (|P| is absolute value of P). The feedback group used a device to measure the applied compression; the device consists of a capacitive sensor of thin polyurethane foam between conductive fabric layers and a microcomputer/Bluetooth transmitter under a vacuum seal that fits into a fabric pocket of a lymphedema garment at the posterior ankle and pairs with a mobile device. A lymphology-certified therapist coordinated training. Data were collected with a pen/paper tool and analyzed with Student's t test.
RESULTS


The instruction+feedback group was closer to target after training (|Ppre - 35|= 10 ± 12 mm Hg; |Ppost - 35|=5 ± 4 mm Hg; P <.05; paired t test) than the instruction only group (|Ppre- 35|=19 ± 11 mm Hg; |Ppost - 35|=12 ±12 mm Hg; not significant).
CONCLUSION


This wearable mobile pressure sensor device assists practitioners in applying hook-and-loop lymphedema garments closer to target pressure. Larger studies with clinicians and research that involves patient application of compression are warranted.",2020,"A study was conducted to assess the feasibility of applying a sensor-feedback device to train staff to accurately apply garments.
",[],"['instruction+feedback (ie, receiving training on compression application']",[],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.0341872,"A study was conducted to assess the feasibility of applying a sensor-feedback device to train staff to accurately apply garments.
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Goldman', 'Affiliation': 'Fort Healthcare Hyperbaric, Wound and Edema Center, Johnson Creek, Wisconsin.'}]",Wound management & prevention,[]
2439,32459666,Comparison of self- and nurse-measured office blood pressure in patients with chronic kidney disease.,"OBJECTIVE


As blood pressure (BP) control is very important in chronic kidney disease (CKD), we investigated how office BP is influenced by the measurement circumstances and compared nonautomated self- and nurse-measured BP values.
MATERIALS AND METHODS


Two hundred stage 1-5 CKD patients with scheduled visits to an outpatient clinic were randomized to either self-measured office BP (SMOBP) followed by nurse-measured office BP (NMOBP) or NMOBP followed by SMOBP. The participants had been educated to perform the self-measurement in at least one previous visit. The SMOBP and NMOBP measurement series both consisted of three recordings, and the means of the last two recordings during SMOBP and NMOBP were compared for the 174 (mean age 52.5 years) with complete BP data.
RESULTS


SMOBP and NMOBP showed similar systolic (135.3 ± 16.6 vs 136.4 ± 17.4 mmHg, Δ = 1.1 mmHg, P = 0.13) and diastolic (81.5 ± 10.2 vs 82.2 ± 10.4 mmHg, Δ = 0.6 mmHg, P = 0.09) values. The change in BP from the first to the third recording was not different for SMOBP and NMOBP. In 17 patients, systolic SMOBP was ≥10 mmHg higher than NMOBP and in 28 patients systolic NMOBP exceeded SMOBP by ≥10 mmHg. The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
CONCLUSION


In a population of CKD patients, there is no clinically relevant difference in SMOBP and NMOBP when recorded at the same visit. However, in 25% of the patients, systolic BP differs ≥10 mmHg between the two measurement modalities.",2020,"The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
","['Two hundred stage 1-5 CKD patients with scheduled visits to an outpatient clinic', 'chronic kidney disease (CKD', 'patients with chronic kidney disease']","['self-measured office BP (SMOBP) followed by nurse-measured office BP (NMOBP) or NMOBP followed by SMOBP', 'self- and nurse-measured office blood pressure']","['systolic SMOBP', 'systolic SMOBP and NMOBP', 'similar systolic', 'diastolic', 'systolic BP', 'change in BP', 'SMOBP and NMOBP']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}]",,0.0287159,"The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
","[{'ForeName': 'Birgitte Godskesen', 'Initials': 'BG', 'LastName': 'Tougaard', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Kathrine Skaaning', 'Initials': 'KS', 'LastName': 'Laursen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Jens Dam', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Buus', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000453']
2440,32459669,"Use of real-time visual feedback during overground walking training on gait symmetry and velocity in patients with post-stroke hemiparesis: randomized controlled, single-blind study.","This study aimed to determine the efficacy of using real-time visual feedback during overground walking training to improve walking function in patients with post-stroke hemiparesis. Twenty-four patients with post-stroke hemiparesis who were able to walk independently under less impact of synergy pattern on the affected lower limbs (Brunnstrom stage IV or V) were randomly assigned to either the experimental group or the control group. All subjects performed overground walking for 30 min, three times a week for 6 weeks, with real-time visual feedback (weight load to the affected lower limb) provided during training for subjects in the experimental group. Outcome measures comprised the timed up-and-go test and gait parameters (step length, stride length, single and double support times, step and stride length ratios, and single support time ratio). In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio. Furthermore, post-test values of all parameters were significantly more improved in the experimental group than in the control group (P < 0.05). Our findings suggest that real-time visual feedback may be an advantageous therapeutic adjunct to reinforce the effects of overground walking training in patients with post-stroke hemiparesis.",2020,"In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio.","['Twenty-four patients with post-stroke hemiparesis who were able to walk independently under less impact of synergy pattern on the affected lower limbs (Brunnstrom stage IV or V', 'patients with post-stroke hemiparesis']","['overground walking training', 'real-time visual feedback during overground walking training']","['gait symmetry and velocity', 'walking function', 'timed up-and-go test and gait parameters (step length, stride length, single and double support times, step and stride length ratios, and single support time ratio', 'double support time and step length ratio']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}]",24.0,0.0246643,"In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio.","[{'ForeName': 'Jin-Seop', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Sunmoon University, 70 Sumoon-ro 221 Beon-Gil, Tangjeong-Myeon, Asan-Si, Chungcheongnam-do.'}, {'ForeName': 'Duck-Won', 'Initials': 'DW', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Cheongju University, 298 Daeseong-ro, Cheongwon-gu, Cheongju, Chungcheongbuk-do, Republic of Korea.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000419']
2441,32459670,"Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial.","Total knee replacement (TKR) is continuously increasing with significantly faster recovery times. Soft tissue pain and edema of operated limbs play an important role in early functional recovery. The present study aims to evaluate the effectiveness of the combination of Kinesiotaping and Lymphatic drainage for the containment of pain and edema as well as the improvement of the range of motion of the knee as integration with standard postoperative rehabilitation. Ninety-nine TKR patients were included in the randomized clinical trial and divided into three groups: Kinesiotaping and Lymphatic drainage Group, Lymphatic drainage Group, and Kinesiotaping Group. The assessment was carried out on days 2-4-6 postoperation. All the patients had also standard reeducation sessions. It was observed that both Kinesiotaping and Lymphatic drainage was useful in reducing pain and edema. A significantly higher improvement was observed in the group in which Lymphatic drainage was associated with Kinesiotaping with respect to the individual treatments, for pain and leg circumference over and under the knee, and at the ankle. Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups. No difference was found between Kinesiotaping and Lymphatic drainage. In conclusion, the treatment with a combination Kinesiotaping and Lymphatic drainage provided better results on pain and edema observed as early as the first days after the intervention, thus may be considered a valid support for standard rehabilitation and pharmacological intervention.",2020,Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups.,"['Ninety-nine TKR patients', 'patients with total knee replacement']","['manual lymphatic drainage and Kinesiotaping', 'Kinesiotaping and Lymphatic drainage', 'Kinesiotaping and Lymphatic drainage Group, Lymphatic drainage Group, and Kinesiotaping Group', 'Total knee replacement (TKR']","['Kinesiotaping and Lymphatic drainage', 'pain, edema, and range of motion', 'flexion degree', 'pain and edema', 'pain and leg circumference']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0398480', 'cui_str': 'Drainage of lymphatics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0398480', 'cui_str': 'Drainage of lymphatics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",99.0,0.031628,Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tornatore', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'De Luca', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ciccarello', 'Affiliation': 'Anesthesia-Resuscitation and Intensive care Unit, Rizzoli Sicilia Department, Bagheria, Palermo, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Benedetti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000417']
2442,32459724,Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.,"STUDY DESIGN


Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX® Putty) with autograft in instrumented posterolateral fusion (PLF) surgery.
OBJECTIVES


To 1) compare PLF rates between 1 and 2 years follow-up and between graft types, and 2) explore the role of bone grafting based on the location of the PLF mass.
SUMMARY OF BACKGROUND DATA


There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting.
METHODS


100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1 year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment were blindly assessed on CT-scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (p < 0.05).
RESULTS


The 2-year PLF rate (66 patients) was 70% at the AttraX® Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595). Ongoing bone formation was only observed between the facet joints.
CONCLUSIONS


This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX® Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting.
LEVEL OF EVIDENCE


2.",2020,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","['100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF']",['bone graft substitute (AttraX® Putty) with autograft in instrumented posterolateral fusion (PLF) surgery'],"['2-year PLF rate', 'Intertransverse and facet fusion', 'PLF rates', 'PLF rate', 'fusion rates', 'Increasing Fusion Rate', 'Ongoing bone formation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",100.0,0.0881156,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F Cumhur', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoebink', 'Affiliation': 'Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Job L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Rene M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003558']
2443,32459738,"Effects of Exercise on Body Posture, Functional Movement, and Physical Fitness in Children With Overweight/Obesity.","Molina-Garcia, P, Mora-Gonzalez, J, Migueles, JH, Rodriguez-Ayllon, M, Esteban-Cornejo, I, Cadenas-Sanchez, C, Plaza-Florido, A, Gil-Cosano, JJ, Pelaez-Perez, MA, Garcia-Delgado, G, Vanrenterghem, J, and Ortega, FB. Effects of exercise on body posture, functional movement, and physical fitness in children with overweight/obesity. J Strength Cond Res XX(X): 000-000, 2020-This study aims to analyze whether a 13-week exercise program based on ""movement quality"" and ""multi-games"" can lead to simultaneous benefits to body posture, fundamental movements, and physical fitness of children with overweight/obesity. A total of 64 children (10.9 ± 1.3 years, 25.9 ± 3.8 kg·m, 38 girls and 26 boys) with overweight/obesity were assigned either to a 13-week exercise-based intervention group (IG) (n = 33) or to a control group (CG) (n = 31). Subjects underwent assessments of basic anthropometry (body mass and height), body posture (2-dimensional photogrammetry), fundamental movements (Functional Movement Screen), and physical fitness (1 repetition maximum [1RM] arm and leg press, and ALPHA test battery). After the exercise program, the IG reduced lower limb angle (high effect size: -0.82 SDs; p = 0.001) and plumb-tragus distance (low effect: -0.43 SDs; p = 0.002) in the sagittal plane and increased lower limb angle in the frontal plane (high effect: 0.82 SDs; p = 0.003) compared with the CG. The IG improved their performance in deep squat (p = 0.004), active straight leg raise (p < 0.001), 1RM arm (low effect: 0.46 SDs; p = 0.002), handgrip strength (medium effect: 0.53 SDs; p < 0.001), and standing long jump (medium effect: 0.59 SDs; p = 0.003), all compared with the CG. In conclusion, children with overweight/obesity who participated in our 13-week exercise program developed a better alignment of the head and lower limb, improved their performance in fundamental movements, and experienced global muscular strength gains compared with the peers who continued with their usual lives. Among other potential implications, these improvements could contribute to the prevention of musculoskeletal disorders associated with childhood obesity and could increase adherence by positioning these children in a better physical status to keep practicing exercise.",2020,"The IG improved their performance in deep squat (p = 0.004), active straight leg raise (p < 0.001), 1RM arm (low effect: 0.46 SDs; p = 0.002), handgrip strength (medium effect: 0.53 SDs; p < 0.001), and standing long jump (medium effect: 0.59 SDs; p = 0.003), all compared with the CG.","['64 children (10.9 ± 1.3 years, 25.9 ± 3.8 kg·m, 38 girls and 26 boys) with overweight/obesity', 'Children With Overweight/Obesity', 'children with overweight/obesity who participated in our 13-week', 'children with overweight/obesity']","['control group (CG', 'J Strength Cond Res XX(X', 'exercise', '13-week exercise program based on ""movement quality"" and ""multi-games', 'exercise program', 'Exercise', '13-week exercise-based intervention group (IG']","['active straight leg raise', 'basic anthropometry (body mass and height), body posture (2-dimensional photogrammetry), fundamental movements (Functional Movement Screen), and physical fitness (1 repetition maximum [1RM] arm and leg press, and ALPHA test battery', 'body posture, functional movement, and physical fitness', 'Body Posture, Functional Movement, and Physical Fitness', 'lower limb angle', 'handgrip strength', 'performance in fundamental movements, and experienced global muscular strength gains', 'deep squat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",64.0,0.0264643,"The IG improved their performance in deep squat (p = 0.004), active straight leg raise (p < 0.001), 1RM arm (low effect: 0.46 SDs; p = 0.002), handgrip strength (medium effect: 0.53 SDs; p < 0.001), and standing long jump (medium effect: 0.59 SDs; p = 0.003), all compared with the CG.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Molina-Garcia', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jairo H', 'Initials': 'JH', 'LastName': 'Migueles', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rodriguez-Ayllon', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Esteban-Cornejo', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cadenas-Sanchez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Plaza-Florido', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose J', 'Initials': 'JJ', 'LastName': 'Gil-Cosano', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Pelaez-Perez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Garcia-Delgado', 'Affiliation': 'Research Group CTS-545 ERGOLAB ""Sport Physical Activity and Ergonomy to Life Quality,"" Department of Physical and Sports Education, Faculty of Sports Science, University of Granada, Granada, Spain.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Vanrenterghem', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through Physical Activity"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003655']
2444,32459755,"Comparison of Primary Closure, Secondary Closure, and Limberg Flap in the Surgical Treatment of Pilonidal Cysts.","There are few studies comparing methods for pilonidal cyst closure. This study was conducted to compare simple surgical closure, secondary healing, and closure using a Limberg flap in the treatment of patients affected with pilonidal cysts. In total, 150 patients with pilonidal cysts were selected and randomized into 3 groups, with 50 participants in each group. Group A underwent primary closure, Group B underwent secondary closure, and Group C underwent closure with a Limberg flap. Operating time, amount of pain after surgery, time to mobilization, time until return to work, time for complete healing, time until being able to sit on the toilet without pain, postoperative complications including infection and recurrence, and seroma and edema after surgery were compared among the 3 groups. Duration of surgery in the Limberg flap group was significantly longer than the duration of surgery in Group A or Group B (p < .001). The time to patient mobilization, the time when the patient returned to work, the time to complete healing, and the time to being able to sit on the toilet without pain were significantly shorter in Group C than in Group A or Group B (p < .001). Although the procedure takes longer when using a Limberg flap, it appears to be a more effective method in the surgical treatment of patients with pilonidal cyst because of the reduced healing time and improved functional status after the procedure.",2020,Duration of surgery in the Limberg flap group was significantly longer than the duration of surgery in Group A or Group B (p < .001).,"['150 patients with pilonidal cysts', 'patients affected with pilonidal cysts', 'patients with pilonidal cyst']","['primary closure, Group B underwent secondary closure, and Group C underwent closure with a Limberg flap']","['Duration of surgery', 'time to complete healing, and the time to being able to sit on the toilet without pain', 'Operating time, amount of pain after surgery, time to mobilization, time until return to work, time for complete healing, time until being able to sit on the toilet without pain, postoperative complications including infection and recurrence, and seroma and edema', 'time to patient mobilization', 'healing time and improved functional status']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal cyst'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441029', 'cui_str': 'Limberg flap'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0560880', 'cui_str': 'Able to sit'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",150.0,0.019141,Duration of surgery in the Limberg flap group was significantly longer than the duration of surgery in Group A or Group B (p < .001).,"[{'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Maghsudi', 'Affiliation': ''}, {'ForeName': 'Hojjat', 'Initials': 'H', 'LastName': 'Almasi', 'Affiliation': ''}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Mousavai Toomatari', 'Affiliation': ''}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Fasihi', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Akhavan Salamat', 'Affiliation': ''}, {'ForeName': 'Seyed Babak', 'Initials': 'SB', 'LastName': 'Mousavi Toomatari', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hemmati', 'Affiliation': ''}]",Plastic surgical nursing : official journal of the American Society of Plastic and Reconstructive Surgical Nurses,['10.1097/PSN.0000000000000297']
2445,32459776,Comparison of Treatment Outcomes after Collagenase Injection and Percutaneous Needle Fasciotomy for Dupuytren's Contracture: Objective and Subjective Comparisons with a 3-Year Follow-Up.,"BACKGROUND


This study compared the effectiveness of injectable collagenase clostridium histolyticum and percutaneous needle fasciotomy in the treatment of Dupuytren's contracture.
METHODS


Patients with a total passive extension deficit of 30 degrees or more in a single digital ray were enrolled and assigned randomly to receive either collagenase clostridium histolyticum injections or percutaneous needle fasciotomy. Preoperative severity of proximal interphalangeal joint contracture for Dupuytren's disease was classified according to the British Society for Surgery of the Hand as less than 30 degrees (stage I) or 30 degrees or more (stage II).
RESULTS


Of the 70 patients enrolled, 36 patients with 46 joints received collagenase clostridium histolyticum injections and 34 patients with 48 joints received percutaneous needle fasciotomy. At day 30, successful corrections were obtained in only 50 percent of the injection group and 67 percent of the fasciotomy group for stage II proximal interphalangeal joints. Recurrences were frequent among patients with stage II joint contractures. The mean Quick Disabilities of the Arm, Shoulder and Hand questionnaire score at day 30 was significantly higher in the injection group compared with the fasciotomy group (7.5 versus 4.2, respectively). In the injection group, adverse events were reported for all patients. In the fasciotomy group, complications were reported for 15 percent of patients.
CONCLUSIONS


The collagenase clostridium histolyticum and percutaneous needle fasciotomy groups had similar outcomes for Dupuytren's contracture with 3 years' follow-up. Recurrences were frequent among patients with stage II proximal interphalangeal joint contractures. The Unité Rhumatologique des Affections de la Main scale and Quick Disabilities of the Arm, Shoulder and Hand questionnaire score decreased significantly for both groups at final follow-up.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"The mean Quick Disabilities of the Arm, Shoulder and Hand questionnaire score at day 30 was significantly higher in the injection group compared with the fasciotomy group (7.5 versus 4.2, respectively).","['36 patients with 46 joints received', 'and 34 patients with 48 joints received', 'Patients with a total passive extension deficit of 30 degrees or more in a single digital ray', ""Dupuytren's Contracture"", 'patients with stage II proximal interphalangeal joint contractures', 'patients with stage II joint contractures', '70 patients enrolled', ""Dupuytren's contracture""]","['percutaneous needle fasciotomy', 'collagenase clostridium histolyticum injections', 'collagenase clostridium histolyticum injections or percutaneous needle fasciotomy', 'injectable collagenase clostridium histolyticum and percutaneous needle fasciotomy', 'Collagenase Injection and Percutaneous Needle Fasciotomy']","['mean Quick Disabilities of the Arm, Shoulder and Hand questionnaire score', 'Unité Rhumatologique des Affections de la Main scale and Quick Disabilities of the Arm, Shoulder and Hand questionnaire score', 'complications', 'adverse events', 'Recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0013312', 'cui_str': ""Dupuytren's contracture""}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1563055', 'cui_str': 'Interphalangeal joint structure'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0009918', 'cui_str': 'Contracture of joint'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0185188', 'cui_str': 'Division of fascia'}, {'cui': 'C4301823', 'cui_str': 'collagenase Clostridium histolyticum Injection'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009053', 'cui_str': 'collagenase Clostridium histolyticum'}, {'cui': 'C0162745', 'cui_str': 'COLLAGENASE'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",70.0,0.038712,"The mean Quick Disabilities of the Arm, Shoulder and Hand questionnaire score at day 30 was significantly higher in the injection group compared with the fasciotomy group (7.5 versus 4.2, respectively).","[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Ichihara City, Japan From the Department of Orthopedic Surgery, Chiba Rosai Hospital.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006828']
2446,32459885,Pharmacokinetic Comparison of Capsule and Tablet Formulations of Opicapone in Healthy Japanese Subjects: Phase 1 Study.,"Opicapone, a peripheral, long-acting catechol-O-methyltransferase inhibitor has been shown to improve wearing-off phenomenon in randomized, double-blind studies. This study compared the pharmacokinetic characteristics of opicapone small-tablet and size 1 capsule formulations after single oral administration to healthy Japanese subjects. In this open-label, randomized, 2-way and 2-period crossover phase 1 study, 48 healthy male subjects (aged 20 to 45 years; body mass index, 18.5 to <30.0 kg/m 2  ) were randomly assigned to 2 cohorts (n = 24 each), which were administered opicapone 25 or 50 mg in a tablet-capsule or capsule-tablet sequence under fasted conditions. Blood samples were collected for pharmacokinetic analysis before opicapone capsule/tablet administration and at regular intervals over 24 hours after administration. Compared with capsules, tablets were associated with higher C max  and AUC last/0-∞  values. However, t 1/2  and t max  values were similar with opicapone 25- and 50-mg capsules/tablets. Geometric mean ratios (tablets/capsules) of C max  , AUC last  , and AUC 0-∞  were 1.24, 1.18, and 1.19, respectively, for the 25-mg dose and 1.42, 1.28, and 1.27, respectively, for the 50-mg dose. Opicapone was well tolerated, and no serious adverse events occurred. A small tablet formulation of opicapone proposed for use in Japanese clinical trials was associated with apparent greater exposure compared with the existing hard capsule formulation, which should be considered when developing opicapone for Japanese patients.",2020,"Compared with capsules, tablets were associated with higher C max  and AUC last/0-∞  values.","['Healthy Japanese Subjects', 'healthy Japanese subjects', 'Japanese patients', '48 healthy male subjects (aged 20 to 45 years; body mass index, 18.5 to <30.0 kg/m 2  ']","['Capsule and Tablet Formulations of Opicapone', 'Opicapone', 'opicapone small-tablet and size 1 capsule formulations', 'opicapone 25 or 50 mg in a tablet-capsule or capsule-tablet sequence under fasted conditions', 'opicapone']","['higher C max  and AUC last/0-∞  values', 'Geometric mean ratios (tablets/capsules) of C max  , AUC last  , and AUC 0-∞']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C2933912', 'cui_str': 'opicapone'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]",48.0,0.296566,"Compared with capsules, tablets were associated with higher C max  and AUC last/0-∞  values.","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Matsuyama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'National Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Iwai', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.802']
2447,32459919,Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.,"BACKGROUND


Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS


We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale.
RESULTS


In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS


In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).",2020,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","['patients with severe Covid-19 not requiring mechanical ventilation', 'hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia', 'Patients with Severe Covid-19', '397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days']",['intravenous remdesivir'],"['worsening respiratory failure', 'ordinal scale', 'distribution in clinical status', 'clinical status on day 14, assessed on a 7-point ordinal scale', 'elevated alanine aminotransferase level', 'nausea', 'constipation', 'clinical status', 'median duration of treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",397.0,0.213119,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Goldman', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David C B', 'Initials': 'DCB', 'LastName': 'Lye', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Marks', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Montejano', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Mi-Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Nahass', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Yao-Shen', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Towner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Tashima', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Diaz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); NewYork-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015301']
2448,32459944,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Edwards', 'Affiliation': 'Veterans Affairs Portland Health Care System, Portland, OR edwarsam@ohsu.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
2449,32459945,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Peele', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Diane P', 'Initials': 'DP', 'LastName': 'Holder', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
2450,32459946,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Stevens', 'Affiliation': 'Milken Institute School of Public Health, Washington, DC mordecai@gwu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
2451,32459947,"Health Care Hotspotting - A Randomized, Controlled Trial. Reply.",,2020,,[],[],['Health Care'],[],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.196298,,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA afink@mit.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
2452,32461916,Social robots as treatment agents: Pilot randomized controlled trial to deliver a behavior change intervention.,"Social robots are increasingly demonstrating effectiveness as low-intensity behavior change agents. Key targets for these behavioral interventions include daily lifestyle behaviors with significant health consequences, such as the consumption of high-calorie foods and drinks ('snacks'). A pilot randomized controlled trial using a stepped-wedge design was conducted to determine the efficacy of a motivational intervention by an autonomous robot, to help reduce high-calorie snacks. Twenty-six adults were randomized to receive Immediate or 4-week Delayed treatment, with assessments at Baseline and Weeks 4 and 8. The treatment comprised motivation enhancement and self-management training using mental imagery (Functional Imagery Training). A significant condition by time effect for snack episode reduction was obtained,  F (2, 32.06) = 4.30,  p  = .022. The Immediate condition significantly reduced snacking between Baseline and Week 4 ( d  = -1.06), while the Delayed condition did not ( d  = -0.08). Immediate participants maintained their improvement between Weeks 4 and 8 ( d  = -0.18), and Delayed participants then showed a significant fall ( d  = -1.42). Overall, 'Immediate' participants decreased their snack episodes by 54% and 'Delayed' decreased by 62% from Baseline to Week 8, and an average weight reduction of 4.4 kg was seen across over the first 2 weeks of treatment. Four weeks after starting the intervention, both conditions had significant increases in perceived confidence to control snack intake for time duration, specific scenarios and emotional states ( d  = 0.61 to 1.42). Working alliance was significantly correlated with reduced snack episodes. The pilot's results appear to suggest that the robot-delivered intervention may be as effective as a human clinician delivering a similar intervention. The robot-delivered pilot achieved similar snack episode reduction in the first four weeks (FIT-R, 55%) when compared with the human-delivered version by a trained clinician (FIT-H, 49%). Overall, the results provide preliminary evidence for an autonomous social robot to deliver a low-intensity treatment on dietary intake without the need for human intervention. Future trials should extend the deployment of the robot-delivered intervention protocol to other low-intensity behavioral outcomes.",2020,"Four weeks after starting the intervention, both conditions had significant increases in perceived confidence to control snack intake for time duration, specific scenarios and emotional states (",['Twenty-six adults'],"['behavior change intervention', 'motivation enhancement and self-management training using mental imagery (Functional Imagery Training', 'motivational intervention']","['snack episodes', 'perceived confidence to control snack intake for time duration, specific scenarios and emotional states ', 'snack episode reduction', 'average weight reduction', 'Delayed', 'Working alliance']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",26.0,0.0385739,"Four weeks after starting the intervention, both conditions had significant increases in perceived confidence to control snack intake for time duration, specific scenarios and emotional states (","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Robinson', 'Affiliation': ""Centre for Children's Health Research, Institute of Health and Biomedical Innovation and School of Psychology and Counselling, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Connolly', 'Affiliation': ""Centre for Children's Health Research, Institute of Health and Biomedical Innovation and School of Psychology and Counselling, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research, Institute of Health and Biomedical Innovation and School of Psychology and Counselling, Queensland University of Technology, Brisbane, Australia.""}]",Internet interventions,['10.1016/j.invent.2020.100320']
2453,32461931,Comparison of Efficacy between Clopidogrel and Ticagrelor in Patients with Acute Coronary Syndrome after Interventional Treatment and Their Effects on IL-6.,"Background


We aimed to compare the efficacy between clopidogrel and ticagrelor in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI) and their effects on IL-6.
Methods


A retrospective analysis and collection of 200 ACS patients diagnosed by the Department of Cardiology, Affiliated Hospital of Qingdao University, Qingdao, China in 2016 were performed. Patients were randomly divided into clopidogrel group and ticagrelor group. Data of left ventricular ejection fraction and ACS clinical classification before PCI, PCI treatment, IL-6, platelet aggregation status, maximum platelet aggregation rate (MPAR), P2Y12 response unit (PRU) and adverse reaction of patients were collected. After PCI, patients were followed up for 1 year to compare the ischemia after treatment between clopidogrel group and tigravilol group.
Results


MPAR and PRU after PCI of clopidogrel group were significantly higher than those of ticagrelor group ( P <0.05). The expression of IL-6 in two groups peaked at 1 day after PCI and then decreased. That of ticagrelor group was consistently lower than that of clopidogrel group ( P <0.05). The incidence of ischemic events after treatment in clopidogrel group was significantly higher than that in ticagrelor group ( P <0.001).
Conclusion


Compared with clopidogrel, tigerrilol had more significant inhibition of platelet aggregation after PCI in ACS patients, and tigerrilol had better effect after interventional treatment in ACS patients. In addition, compared with clopidogrel, tegrel can significantly inhibit the expression of IL-6 in patients with ACS and better alleviate the inflammatory response after PCI.",2020,"The incidence of ischemic events after treatment in clopidogrel group was significantly higher than that in ticagrelor group ( P <0.001).
","['200 ACS patients diagnosed by the Department of Cardiology, Affiliated Hospital of Qingdao University, Qingdao, China in 2016 were performed', 'patients with ACS', 'Patients with Acute Coronary Syndrome after Interventional Treatment and Their Effects on IL-6', 'patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI']","['Clopidogrel and Ticagrelor', 'clopidogrel and ticagrelor', 'clopidogrel', 'ticagrelor']","['platelet aggregation', 'IL-6, platelet aggregation status, maximum platelet aggregation rate (MPAR), P2Y12 response unit (PRU) and adverse reaction', 'incidence of ischemic events', 'expression of IL-6', 'inflammatory response']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0213787,"The incidence of ischemic events after treatment in clopidogrel group was significantly higher than that in ticagrelor group ( P <0.001).
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Medical Consultation Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Haichu', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Len', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shanglang', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Iranian journal of public health,[]
2454,32161034,No benefit of faecal microbiota transplantation for IBS-D.,"Review of:  Aroniadis OC, Brandt LJ, Oneto C,  et al  Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.  Lancet Gastroenterol Hepatol  2019;4:675-85.",2020,"Review of:  Aroniadis OC, Brandt LJ, Oneto C,  et al  Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.  ","['IBS-D', 'diarrhoea-predominant irritable bowel syndrome']",['placebo'],['faecal microbiota transplantation'],"[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}]",,0.349674,"Review of:  Aroniadis OC, Brandt LJ, Oneto C,  et al  Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.  ",[],Drug and therapeutics bulletin,['10.1136/dtb.2020.000013']
2455,31388184,Diagnosis of epithelial ovarian cancer using a combined protein biomarker panel.,"BACKGROUND


An early detection tool for EOC was constructed from analysis of biomarker expression data from serum collected during the UKCTOCS.
METHODS


This study included 49 EOC cases (19 Type I and 30 Type II) and 31 controls, representing 482 serial samples spanning seven years pre-diagnosis. A logit model was trained by analysis of dysregulation of expression data of four putative biomarkers, (CA125, phosphatidylcholine-sterol acyltransferase, vitamin K-dependent protein Z and C-reactive protein); by scoring the specificity associated with dysregulation from the baseline expression for each individual.
RESULTS


The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set. Samples were analysed as a simulated annual screening programme, the algorithm diagnosed cases with >30% PPV 1-2 years pre-diagnosis. For Type II cases (~80% were HGS) the algorithm classified 64% at 1 year and 28% at 2 years tDx as severe.
CONCLUSIONS


The panel has the potential to diagnose EOC one-two years earlier than current diagnosis. This analysis provides a tangible worked example demonstrating the potential for development as a screening tool and scrutiny of its properties. Limits on interpretation imposed by the number of samples available are discussed.",2019,"The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set.","['For Type II cases (~80% were HGS', '49 EOC cases (19 Type I and 30 Type II) and 31 controls, representing 482 serial samples spanning seven years pre-diagnosis']",[],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1568891', 'cui_str': 'HGS protein, human'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],[],49.0,0.0221786,"The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Russell', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ciaren', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'School of Biological Sciences, Queens University Belfast, Chlorine Gardens, Belfast, BT9 5DL, UK.'}, {'ForeName': 'Alfonsina', 'Initials': 'A', 'LastName': ""D'Amato"", 'Affiliation': 'Department of Pharmaceutical Sciences, University of Milan, Milano, Lombardy, Italy.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gentry-Maharaj', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Jatinderpal K', 'Initials': 'JK', 'LastName': 'Kalsi', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Whetton', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK. i.jacobs@unsw.edu.au.'}, {'ForeName': 'Robert L J', 'Initials': 'RLJ', 'LastName': 'Graham', 'Affiliation': 'School of Biological Sciences, Queens University Belfast, Chlorine Gardens, Belfast, BT9 5DL, UK. r.graham@qub.ac.uk.'}]",British journal of cancer,['10.1038/s41416-019-0544-0']
2456,31388185,Tumour-infiltrating CD8 +  lymphocytes and colorectal cancer recurrence by tumour and nodal stage.,"BACKGROUND


Intratumoural T-cell infiltrate intensity cortes wrelaith clinical outcome in stage II/III colorectal cancer (CRC). We aimed to determine whether this association varies across this heterogeneous group.
METHODS


We performed a pooled analysis of 1804 CRCs from the QUASAR2 and VICTOR trials. Intratumoural CD8 +  and CD3 +  densities were quantified by immunohistochemistry in tissue microarray (TMA) cores, and their association with clinical outcome analysed by Cox regression. We validated our results using publicly available gene expression data in a pooled analysis of 1375 CRCs from seven independent series.
RESULTS


In QUASAR2, intratumoural CD8 +  was a stronger predictor of CRC recurrence than CD3 +  and showed similar discriminative ability to both markers in combination. Pooled multivariable analysis of both trials showed increasing CD8 +  density was associated with reduced recurrence risk independent of confounders including DNA mismatch repair deficiency, POLE mutation and chromosomal instability (multivariable hazard ratio [HR] for each two-fold increase = 0.92, 95%CI = 0.87-0.97, P = 3.6 × 10 -3 ). This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090. Analysis of tumour CD8A expression in the independent validation cohort revealed similar variation in prognostic value across risk strata (P INTERACTION  = 0.048).
CONCLUSIONS


The prognostic value of intratumoural CD8 +  cell infiltration in stage II/III CRC varies across tumour and nodal risk strata.",2019,"This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090.",['stage II/III colorectal cancer (CRC'],[],"['tumour CD8A expression', 'CRC recurrence', 'Tumour-infiltrating CD8 +  lymphocytes and colorectal cancer recurrence', 'CD8 +  density', 'DNA mismatch repair deficiency, POLE mutation and chromosomal instability', 'Intratumoural CD8 +  and CD3 +  densities']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1257806', 'cui_str': 'Chromosome Instability'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}]",1804.0,0.198792,"This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Glaire', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Domingo', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sveen', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jarle', 'Initials': 'J', 'LastName': 'Bruun', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Nesbakken', 'Affiliation': 'Department of Gastroenterological Surgery & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nicholson', 'Affiliation': 'Department of Statistics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Novelli', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Lawson', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Dahmane', 'Initials': 'D', 'LastName': 'Oukrif', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Wanja', 'Initials': 'W', 'LastName': 'Kildal', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Havard E', 'Initials': 'HE', 'LastName': 'Danielsen', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kerr', 'Affiliation': 'Oxford Cancer Centre, Churchill Hospital, Oxford University Hospitals Foundation NHS Trust, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Nuffield Division of Clinical Laboratory Sciences, University of Oxford, Oxford, OX3 9 DU, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Ragnhild A', 'Initials': 'RA', 'LastName': 'Lothe', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Church', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK. dchurch@well.ox.ac.uk.'}]",British journal of cancer,['10.1038/s41416-019-0540-4']
2457,31426685,Thoracic epidural anaesthesia and analgesia ameliorates surgery-induced stress response and postoperative pain in patients undergoing radical oesophagectomy.,,2019,,['patients undergoing radical oesophagectomy'],[],['stress response and postoperative pain'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0249437,,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuehao', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Pingbo', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060519866943']
2458,31486356,Association between breakfast skipping and postprandial hyperglycaemia after lunch in healthy young individuals.,"Breakfast skipping has become an increasing trend in the modern lifestyle and may play a role in obesity and type 2 diabetes. In our previous studies in healthy young individuals, a single incident of breakfast skipping increased the overall 24-h blood glucose and elevated the postprandial glycaemic response after lunch; however, it was difficult to determine whether this response was due to breakfast omission or the extra energy (i.e. lunch plus breakfast contents). The present study aimed to assess the postprandial glycaemic response and to measure their hormone levels when healthy young individuals had identical lunch and dinner, and the 24-h average blood glucose as a secondary outcome. Nine healthy young men (19-24 years) participated in two-meal trials: with breakfast (three-meal condition) or without breakfast (breakfast skipping condition). During the meals, each individual's blood glucose was continuously monitored. Skipping breakfast resulted in a significantly higher (P < 0·001) glycaemic response after lunch as compared with the glycaemic response after an identical lunch when breakfast was consumed. Despite the difference in the total energy intake, the 24-h average blood glucose was similar between the two-meal conditions (P = 0·179). Plasma NEFA level was significantly higher (P < 0·05) after lunch when breakfast was omitted, and NEFA level positively correlated with the postprandial glycaemic response (r 0·631, P < 0·01). In conclusion, a single incident of breakfast skipping increases postprandial hyperglycaemia, and associated impaired insulin response, after lunch. The present study showed that skipping breakfast influences glucose regulation even in healthy young individuals.",2019,"Plasma NEFA level was significantly higher (P < 0·05) after lunch when breakfast was omitted, and NEFA level positively correlated with the postprandial glycaemic response (r 0·631, P < 0·01).","['healthy young individuals had identical lunch and dinner, and the 24-h average blood glucose as a secondary outcome', 'Nine healthy young men (19-24 years) participated in two-meal trials: with', 'healthy young individuals']","['breakfast (three-meal condition) or without breakfast (breakfast skipping condition', 'skipping breakfast']","['postprandial hyperglycaemia', 'postprandial glycaemic response', 'total energy intake, the 24-h average blood glucose', 'overall 24-h blood glucose', 'Plasma NEFA level', '0·001) glycaemic response']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}]","[{'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",9.0,0.0245566,"Plasma NEFA level was significantly higher (P < 0·05) after lunch when breakfast was omitted, and NEFA level positively correlated with the postprandial glycaemic response (r 0·631, P < 0·01).","[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Higashi-Hiroshima, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Hatamoto', 'Affiliation': 'Faculty of Sports and Health Science, Fukuoka University, Jonan-ku, Fukuoka 814-0810, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Faculty of Sports and Health Science, Fukuoka University, Jonan-ku, Fukuoka 814-0810, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Tajiri', 'Affiliation': 'Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, Higashi-ku, Kumamoto 862-8502, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Yoshimura', 'Affiliation': 'Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, Higashi-ku, Kumamoto 862-8502, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kiyono', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Toyonaka, Osaka 560-8531, Japan.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Faculty of Sports and Health Science, Fukuoka University, Jonan-ku, Fukuoka 814-0810, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kawanaka', 'Affiliation': 'Faculty of Sports and Health Science, Fukuoka University, Jonan-ku, Fukuoka 814-0810, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Omi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki 305-8574, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Sports and Health Science, Fukuoka University, Jonan-ku, Fukuoka 814-0810, Japan.'}]",The British journal of nutrition,['10.1017/S0007114519001235']
2459,31630589,Observation of the clinical efficacy of dexmedetomidine in flexible bronchoscopy under general anesthesia: clinical case experience exchange.,,2019,,['flexible bronchoscopy under general anesthesia'],['dexmedetomidine'],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0277959,,"[{'ForeName': 'Hongtu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Painless Endoscopy, People's Hospital of Linzi District, The Affiliated Hospital of Binzhou Medical University, Zibo, Shandong, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Painless Endoscopy, People's Hospital of Linzi District, The Affiliated Hospital of Binzhou Medical University, Zibo, Shandong, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Painless Endoscopy, People's Hospital of Linzi District, The Affiliated Hospital of Binzhou Medical University, Zibo, Shandong, China.""}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Department of Painless Endoscopy, People's Hospital of Linzi District, The Affiliated Hospital of Binzhou Medical University, Zibo, Shandong, China.""}]",The Journal of international medical research,['10.1177/0300060519880763']
2460,31662003,Effect of regional arterial infusion combined with early enteral nutrition on severe acute pancreatitis.,,2019,,[],['regional arterial infusion combined with early enteral nutrition'],['severe acute pancreatitis'],[],"[{'cui': 'C0086463', 'cui_str': 'Infusions, Regional Arterial'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]",,0.0269854,,"[{'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Intensive Care Unit, the Second People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Jinbu', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Intensive Care Unit, the Second People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Intensive Care Unit, the First People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Intensive Care Unit, the Second People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Intensive Care Unit, the Second People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ""Intensive Care Unit, the Second People's Hospital of Lianyungang, Lianyungang, Jiangsu Province, China.""}]",The Journal of international medical research,['10.1177/0300060519880760']
2461,27494705,A Preliminary Investigation of Ethnic Differences in Resistance in Multisystemic Therapy.,"Therapy process research suggests that an inverted U-shaped trajectory of client resistance, referred to as the struggle-and-working-through pattern, predicts positive treatment outcomes. However, this research may lack external validity given the exclusive focus on European Americans. This preliminary study explores differences in resistance patterns in a sample of African American and European American juvenile drug offenders and their families (n = 41) participating in Multisystemic Therapy. Resistance was coded from session recordings at the beginning, middle, and end of treatment. There were significant ethnic differences in (a) mean resistance at midtreatment, (b) resistance trajectories, and (c) predictive relationships between resistance trajectories and criminal desistance. Notably, a negative quadratic (i.e., inverted U-shaped) resistance trajectory was more characteristic of European Americans who desisted from crime, whereas a positive quadratic (U-shaped) resistance pattern was more characteristic of African Americans who desisted. There was no relationship between resistance trajectory and later drug abstinence (i.e., cannabis). Within the context of evidence-based therapies, core treatment processes may vary significantly as a function of client ethnicity. We recommend that clinical scientists make efforts to test for ethnic differences in treatment process so that therapies like Multisystemic Therapy can be understood in a more comprehensive and nuanced manner.",2019,"There was no relationship between resistance trajectory and later drug abstinence (i.e., cannabis).",['African American and European American juvenile drug offenders and their families (n\xa0=\xa041) participating in Multisystemic Therapy'],[],"['mean resistance at midtreatment, (b) resistance trajectories, and (c) predictive relationships between resistance trajectories and criminal desistance', 'resistance trajectory and later drug abstinence (i.e., cannabis']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",41.0,0.0283315,"There was no relationship between resistance trajectory and later drug abstinence (i.e., cannabis).","[{'ForeName': 'Caitlin S', 'Initials': 'CS', 'LastName': 'Sayegh', 'Affiliation': 'a Department of Psychology , University of Southern California.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Hall-Clark', 'Affiliation': 'b Department of Psychiatry , University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Dawn D', 'Initials': 'DD', 'LastName': 'McDaniel', 'Affiliation': 'c Boys & Girls Clubs of America , Atlanta , GA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Halliday-Boykins', 'Affiliation': 'd Department of Psychiatry and Behavioral Sciences , Medical University of South Carolina.'}, {'ForeName': 'Phillippe B', 'Initials': 'PB', 'LastName': 'Cunningham', 'Affiliation': 'd Department of Psychiatry and Behavioral Sciences , Medical University of South Carolina.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Huey', 'Affiliation': 'e Department of Psychology and Department of American Studies and Ethnicity , University of Southern California.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2016.1157754']
2462,30209161,TP53  Outperforms Other Androgen Receptor Biomarkers to Predict Abiraterone or Enzalutamide Outcome in Metastatic Castration-Resistant Prostate Cancer.,"PURPOSE


To infer the prognostic value of simultaneous androgen receptor ( AR ) and  TP53  profiling in liquid biopsies from patients with metastatic castration-resistant prostate cancer (mCRPC) starting a new line of  AR  signaling inhibitors (ARSi). Experimental Design:  Between March 2014 and April 2017, we recruited patients with mCRPC ( n  = 168) prior to ARSi in a cohort study encompassing 10 European centers. Blood samples were collected for comprehensive profiling of CellSearch-enriched circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). Targeted CTC RNA sequencing (RNA-seq) allowed the detection of eight  AR  splice variants (ARV). Low-pass whole-genome and targeted gene-body sequencing of  AR  and  TP53  was applied to identify amplifications, loss of heterozygosity, mutations, and structural rearrangements in ctDNA. Clinical or radiologic progression-free survival (PFS) was estimated by Kaplan-Meier analysis, and independent associations were determined using multivariable Cox regression models.
RESULTS


Overall, no single  AR  perturbation remained associated with adverse prognosis after multivariable analysis. Instead, tumor burden estimates (CTC counts, ctDNA fraction, and visceral metastases) were significantly associated with PFS.  TP53  inactivation harbored independent prognostic value [HR 1.88; 95% confidence interval (CI), 1.18-3.00;  P  = 0.008], and outperformed ARV expression and detection of genomic  AR  alterations. Using Cox coefficient analysis of clinical parameters and  TP53  status, we identified three prognostic groups with differing PFS estimates (median, 14.7 vs. 7.51 vs. 2.62 months;  P  < 0.0001), which was validated in an independent mCRPC cohort ( n  = 202) starting first-line ARSi (median, 14.3 vs. 6.39 vs. 2.23 months;  P  < 0.0001).
CONCLUSIONS


In an all-comer cohort, tumor burden estimates and  TP53  outperform any  AR  perturbation to infer prognosis.See related commentary by Rebello et al., p. 1699.",2019,"TP53  inactivation harbored independent prognostic value [HR 1.88; 95% confidence interval (CI), 1.18-3.00;  P  = 0.008], and outperformed ARV expression and detection of genomic  AR  alterations.","['patients with metastatic castration-resistant prostate cancer (mCRPC) starting a new line of  AR  signaling inhibitors (ARSi', 'Metastatic Castration-Resistant Prostate Cancer', 'recruited patients with mCRPC ( n  = 168) prior to ARSi in a cohort study encompassing 10 European centers', 'March 2014 and April 2017']",['simultaneous androgen receptor ( AR ) and  TP53  profiling'],"['ARV expression and detection of genomic  AR  alterations', 'tumor burden estimates (CTC counts, ctDNA fraction, and visceral metastases', 'Clinical or radiologic progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0266284,"TP53  inactivation harbored independent prognostic value [HR 1.88; 95% confidence interval (CI), 1.18-3.00;  P  = 0.008], and outperformed ARV expression and detection of genomic  AR  alterations.","[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'De Laere', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium. bramdelaere@gmail.com.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Oeyen', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mayrhofer', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Whitington', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'van Dam', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Oyen', 'Affiliation': 'Department of Urology, AZ Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Ghysel', 'Affiliation': 'Department of Urology, AZ Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Ampe', 'Affiliation': 'Department of Urology, AZ Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Demey', 'Affiliation': 'Department of Oncology, AZ KLINA, Brasschaat, Belgium.'}, {'ForeName': 'Lucien', 'Initials': 'L', 'LastName': 'Hoekx', 'Affiliation': 'Department of Urology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schrijvers', 'Affiliation': 'Department of Oncology, ZNA Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Brouwers', 'Affiliation': 'Department of Oncology, AZ Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Lybaert', 'Affiliation': 'Department of Oncology, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'Els G', 'Initials': 'EG', 'LastName': 'Everaert', 'Affiliation': 'Department of Oncology, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'De Maeseneer', 'Affiliation': 'Department of Oncology, AZ Sint-Lucas, Brugge, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Strijbos', 'Affiliation': 'Department of Oncology, AZ KLINA, Brasschaat, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bols', 'Affiliation': 'Department of Oncology, AZ Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fransis', 'Affiliation': 'Department of Urology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Beije', 'Affiliation': 'Medical Oncology and Cancer Genomics Netherlands, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Inge E', 'Initials': 'IE', 'LastName': 'de Kruijff', 'Affiliation': 'Medical Oncology and Cancer Genomics Netherlands, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'van Dam', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Brouwer', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Goossens', 'Affiliation': 'Agilent Technologies, Niel, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Heyrman', 'Affiliation': 'Agilent Technologies, Niel, Belgium.'}, {'ForeName': 'Gert G', 'Initials': 'GG', 'LastName': 'Van den Eynden', 'Affiliation': 'Department of Pathology, GZA Hospitals Sint-Augustinus, Antwerp, Belgium.'}, {'ForeName': 'Annemie', 'Initials': 'A', 'LastName': 'Rutten', 'Affiliation': 'Department of Oncology, GZA Hospitals Sint-Augustinus, Antwerp, Belgium.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Del Favero', 'Affiliation': 'Agilent Technologies, Niel, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Rantalainen', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Rajan', 'Affiliation': 'Centre for Molecular Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sleijfer', 'Affiliation': 'Medical Oncology and Cancer Genomics Netherlands, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullén', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yachnin', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Van Laere', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Science for Life Laboratory, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Luc Y', 'Initials': 'LY', 'LastName': 'Dirix', 'Affiliation': 'Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1943']
2463,30299473,Statin Treatment Decreases Mitochondrial Respiration But Muscle Coenzyme Q10 Levels Are Unaltered: The LIFESTAT Study.,"BACKGROUND


Myalgia is a common adverse effect of statin therapy, but the underlying mechanism is unknown. Statins may reduce levels of coenzyme Q10 (CoQ10), which is an essential electron carrier in the mitochondrial electron transport system, thereby impairing mitochondrial respiratory function, potentially leading to myalgia.
OBJECTIVES


To investigate whether statin-induced myalgia is coupled to reduced intramuscular CoQ10 concentration and impaired mitochondrial respiratory function.
METHODS


Patients receiving simvastatin (i.e., statin) therapy (n = 64) were recruited, of whom 25 experienced myalgia (myalgic group) and 39 had no symptoms of myalgia (NS group). Another 20 had untreated high blood cholesterol levels (control group). Blood and muscle samples were obtained. Intramuscular CoQ10 concentration was measured, and mitochondrial respiratory function and reactive oxygen species (ROS) production were measured. Citrate synthase (CS) activity was used as a biomarker of mitochondrial content in skeletal muscle.
RESULTS


Intramuscular CoQ10 concentration was comparable among groups. Mitochondrial complex II-linked respiration was reduced in the statin-myalgic and -NS groups compared with the control group. When mitochondrial respiration was normalized to CS activity, respiration rate was higher in the myalgic group compared with the NS and control groups. Maximal ROS production was similar among groups.
CONCLUSION


Statin therapy appeared to impair mitochondrial complex-II-linked respiration, but the mitochondrial capacity for complex I+II-linked respiration remained intact. Myalgia was not coupled to reduced intramuscular CoQ10 levels. Intrinsic mitochondrial respiratory capacity was increased with statin-induced myalgia but not accompanied by increased ROS production.",2019,Mitochondrial complex II-linked respiration was reduced in the statin-myalgic and -NS groups compared with the control group.,"['Patients receiving simvastatin (i.e., statin) therapy (n = 64) were recruited, of whom 25 experienced myalgia (myalgic group) and 39 had no symptoms of myalgia (NS group']","['Citrate synthase (CS) activity', 'Statin']","['Intramuscular CoQ10 concentration', 'blood cholesterol levels', 'Muscle Coenzyme Q10 Levels', 'Mitochondrial complex II-linked respiration', 'ROS production', 'Mitochondrial Respiration But', 'Myalgia', 'mitochondrial respiratory function and reactive oxygen species (ROS) production', 'Maximal ROS production', 'Intrinsic mitochondrial respiratory capacity', 'CS activity, respiration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1453024', 'cui_str': 'SDHD protein, human'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",64.0,0.0320342,Mitochondrial complex II-linked respiration was reduced in the statin-myalgic and -NS groups compared with the control group.,"[{'ForeName': 'Tine Lovsø', 'Initials': 'TL', 'LastName': 'Dohlmann', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Morville', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anja Birk', 'Initials': 'AB', 'LastName': 'Kuhlman', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karoline Maise', 'Initials': 'KM', 'LastName': 'Chrøis', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn Wulff', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Xlab, Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-01185']
2464,30301829,Expression of AR-V7 and ARv 567es  in Circulating Tumor Cells Correlates with Outcomes to Taxane Therapy in Men with Metastatic Prostate Cancer Treated in TAXYNERGY.,"PURPOSE


Biomarkers aiding treatment optimization in metastatic castration-resistant prostate cancer (mCRPC) are scarce. The presence or absence of androgen receptor (AR) splice variants, AR-V7 and AR v567es , in mCRPC patient circulating tumor cells (CTC) may be associated with taxane treatment outcomes. Experimental Design:  A novel digital droplet PCR (ddPCR) assay assessed AR-splice variant expression in CTCs from patients receiving docetaxel or cabazitaxel in TAXYNERGY (NCT01718353). Patient outcomes were examined according to AR-splice variant expression, including prostate-specific antigen (PSA) 50  response and progression-free survival (PFS).
RESULTS


Of the 54 evaluable patients, 36 (67%) were AR-V7 + , 42 (78%) were AR v567es+ , 29 (54%) were double positive, and 5 (9%) were double negative. PSA 50  response rates at any time were numerically higher for AR-V7 -  versus AR-V7 +  (78% vs. 58%;  P  = 0.23) and for AR v567es-  versus AR v567es+  (92% vs. 57%;  P  = 0.04) patients. When AR-V mRNA status was correlated with change in nuclear AR from cycle 1 day 1 to day 8 ( n  = 24), AR-V7 +  patients ( n  = 16) had a 0.4% decrease versus a 12.9% and 26.7% decrease in AR-V7 - /AR v567es-  ( n  = 3) and AR-V7 - /AR v567es+  ( n  = 5) patients, respectively, suggesting a dominant role for AR-V7 over AR v567es . Median PFS was 12.02 versus 8.48 months for AR-V7 -  versus AR-V7 +  (HR = 0.38;  P  = 0.01), and 12.71 versus 7.29 months for AR v567es-  versus AR v567es+  (HR = 0.37;  P  = 0.02). For AR-V7 + , AR-V7 - /AR v567es+ , and AR-V7 - /AR v567es-  patients, median PFS was 8.48, 11.17, and 16.62 months, respectively ( P  = 0.0013 for trend).
CONCLUSIONS


Although detection of both CTC-specific AR-V7 and AR v567es  by ddPCR influenced taxane outcomes, AR-V7 primarily mediated the prognostic impact. The absence of both variants was associated with the best response and PFS with taxane treatment.See related commentary by Dehm et al., p. 1696.",2019,PSA 50  response rates at any time were numerically higher for AR-V7 -  versus AR-V7 +  (78% vs. 58%;  P  = 0.23) and for AR v567es-  versus AR v567es+  (92% vs. 57%;  P  = 0.04) patients.,"['metastatic castration-resistant prostate cancer (mCRPC', 'Men with Metastatic Prostate Cancer', '54 evaluable patients, 36 (67%) were AR-V7']","['Taxane Therapy', 'docetaxel or cabazitaxel', 'novel digital droplet PCR (ddPCR']","['Median PFS', 'PSA 50  response rates', 'nuclear AR', 'AR-splice variant expression, including prostate-specific antigen (PSA) 50  response and progression-free survival (PFS', 'assessed AR-splice variant expression', 'median PFS']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0154424,PSA 50  response rates at any time were numerically higher for AR-V7 -  versus AR-V7 +  (78% vs. 58%;  P  = 0.23) and for AR v567es-  versus AR v567es+  (92% vs. 57%;  P  = 0.04) patients.,"[{'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Tagawa', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York. pag2015@med.cornell.edu stt2007@med.cornell.edu.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Gjyrezi', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Galletti', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Seaho', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Worroll', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Laval, Quebec, Canada.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Zaher', 'Affiliation': 'Sanofi, Laval, Quebec, Canada.'}, {'ForeName': 'Ted P', 'Initials': 'TP', 'LastName': 'Szatrowski', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Kita', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Tasaki', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Portella', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Kirby', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nanus', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Giannakakou', 'Affiliation': 'Weill Cornell Medicine/Meyer Cancer Center, New York, New York. pag2015@med.cornell.edu stt2007@med.cornell.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-0320']
2465,30395687,Adding Lateral Spine Imaging for Vertebral Fractures to Densitometric Screening: Improving Ascertainment of Patients at High Risk of Incident Osteoporotic Fractures.,"The current diagnosis of osteoporosis is limited to a T-score ≤-2.5. However, asymptomatic vertebral fractures (VF) are known to predict a high risk of subsequent fractures and pharmaceutical intervention is known to reduce future fracture risk in these individuals. In a prospective, population-based cohort of ambulant older women, we sought to evaluate the role of VF detection by screening densitometric lateral spine imaging (LSI) for VF at time of bone density testing to the effect on the magnitude of fracture risk. A total of 1084 women (mean age 75 years ± SD 3 years) had baseline LSI that identified 100 (9%) women with VFs and 89 (8%) with femoral neck (FN) T-score osteoporosis ≤-2.5. Follow-up identified incident clinical spine fracture in 73 (7%), 305 (28%) with any fracture-related hospitalization, and 121 (11%) with a hip fracture-related hospitalization. Compared with those without baseline VF, in those with baseline VF, relative risk (RR) for incident clinical spine, hip, and any fracture were 3.46 (95% confidence interval [CI] 2.14-5.60, p < 0.001); 1.72 (95% CI 1.09-2.71, p = 0.02), and 1.4 (95% CI 1.07-1.84, p = 0.02), respectively. In 675 (62%) of women with femoral neck osteopenia (T-score <-1 to >-2.5), 61 (9%) also had a VF. Compared with those without baseline VF, RR for any incident fragility fractures and fractures at spine and hip in those with baseline VF were 1.6 (95% CI 1.2-2.1, p < 0.01), 3.9 (95% CI 2.2-6.9, p < 0.01), and 1.6 (95% CI 0.9-2.8, p = 0.10), respectively. On basis of the prognosis, older women with LSI VF with osteopenia should be diagnosed with osteoporosis and should be considered for pharmaceutical intervention. © 2018 American Society for Bone and Mineral Research.",2019,"Compared with those without baseline VF, RR for any incident fragility fractures and fractures at spine and hip in those with baseline VF were 1.6 (95% CI 1.2-2.1, p < 0.01), 3.9 (95% CI 2.2-6.9, p < 0.01), and 1.6 (95% CI 0.9-2.8, p = 0.10), respectively.","['Follow-up identified incident clinical spine fracture in 73 (7%), 305 (28%) with any fracture-related hospitalization, and 121 (11%) with a hip fracture-related hospitalization', 'Patients at High Risk of Incident Osteoporotic Fractures', '© 2018 American Society for Bone and Mineral Research', '1084 women (mean age 75 years\u2009±\u2009SD 3 years) had baseline LSI that identified 100 (9%) women with VFs and 89 (8%) with femoral neck (FN) T-score osteoporosis ≤-2.5', 'older women with LSI VF with osteopenia', 'ambulant older women']",['Lateral Spine Imaging'],['femoral neck osteopenia'],"[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",1084.0,0.0892467,"Compared with those without baseline VF, RR for any incident fragility fractures and fractures at spine and hip in those with baseline VF were 1.6 (95% CI 1.2-2.1, p < 0.01), 3.9 (95% CI 2.2-6.9, p < 0.01), and 1.6 (95% CI 0.9-2.8, p = 0.10), respectively.","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Prince', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': ""Centre for Kidney Research, Children's Hospital at Westmead, School of Public Health, Sydney Medical School, The University of Sydney, Sydney, Australia.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Wilson', 'Affiliation': 'Skeletal Health, Hologic, Inc., Marlborough, MA, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Khoo', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schousboe', 'Affiliation': 'Park Nicollet Osteoporosis Center and HealthPartners Institute, and Division of Health Policy and Management, University of Minnesota, Minneapolis, MN, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3595']
2466,30395789,Training Motor Sequences: Effects of Speed and Accuracy Instructions.,"Participants practiced a fixed 3- and a fixed 6-key press sequence for 144 times each. In the speed group, they were instructed to execute their sequences fast without bothering much about errors while the accurate group was instructed to be careful and prevent errors. In the test phase, participants executed series of 3 and 6 responses (a) when all element-specific stimuli were displayed in the familiar order, (b) in response to just the familiar first stimulus, and (c) by responding to random stimuli. The speed instruction yielded stronger sequencing skill while the accuracy instruction developed stronger reaction skill.",2019,The speed instruction yielded stronger sequencing skill while the accuracy instruction developed stronger reaction skill.,[],['Speed and Accuracy Instructions'],['stronger reaction skill'],[],"[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0255515,The speed instruction yielded stronger sequencing skill while the accuracy instruction developed stronger reaction skill.,"[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Barnhoorn', 'Affiliation': 'a Department of Cognitive Psychology & Ergonomics , University of Twente , Enschede , The Netherlands .'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Panzer', 'Affiliation': 'b Institute of Sport Science , Saarland University , Saarbrücken , Germany .'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Godde', 'Affiliation': 'c Jacobs Center on Lifelong Learning and Institutional Development , Jacobs University Bremen , Bremen , Germany .'}, {'ForeName': 'Willem B', 'Initials': 'WB', 'LastName': 'Verwey', 'Affiliation': 'a Department of Cognitive Psychology & Ergonomics , University of Twente , Enschede , The Netherlands .'}]",Journal of motor behavior,['10.1080/00222895.2018.1528202']
2467,30478089,Myeloablative Haploidentical Transplantation Is Superior to Chemotherapy for Patients with Intermediate-risk Acute Myelogenous Leukemia in First Complete Remission.,"PURPOSE


Although myeloablative HLA haploidentical hematopoietic stem cell transplantation (haplo-HSCT) following pretransplant anti-thymocyte globulin (ATG) and granulocyte colony-stimulating factor (G-CSF) stimulated grafts (ATG+G-CSF) has been confirmed as an alternative to HSCT from HLA-matched sibling donors (MSD), the effect of haplo-HSCT on postremission treatment of patients with acute myeloid leukemia (AML) with intermediate risk (int-risk AML) who achieved first complete remission (CR1) has not been defined.
PATIENTS AND METHODS


In this prospective trial, among 443 consecutive patients ages 16-60 years with newly diagnosed  de no vo AML with int-risk cytogenetics, 147 patients with molecular int-risk AML who achieved CR1 within two courses of induction and remained in CR1 at 4 months postremission either received chemotherapy ( n  = 69) or underwent haplo-HSCT ( n  = 78).
RESULTS


The 3-year leukemia-free survival (LFS) and overall survival (OS) were significantly higher in the haplo-HSCT group than in the chemotherapy group (74.3% vs. 47.3%;  P  = 0.0004 and 80.8% vs. 53.5%;  P  = 0.0001, respectively). In the multivariate analysis with propensity score adjustment, postremission treatment (haplo-HSCT vs. chemotherapy) was an independent risk factor affecting the LFS [HR 0.360; 95% confidence interval (CI), 0.163-0.793;  P  = 0.011], OS (HR 0.361; 95% CI, 0.156-0.832;  P  = 0.017), and cumulative incidence of relapse (HR 0.161; 95% CI, 0.057-0.459;  P  = 0.001) either in entire cohort or stratified by minimal residual disease after the second consolidation.
CONCLUSIONS


Myeloablative haplo-HSCT with ATG+G-CSF is superior to chemotherapy as a postremission treatment in patients with int-risk AML during CR1. Haplo-HSCT might be a first-line postremission therapy for int-risk AML in the absence of HLA-MSDs. Haplo-HSCT might be superior to chemotherapy as a first-line postremission treatment of intermediate-risk AML in CR1.",2019,The 3-year leukemia-free survival (LFS) and overall survival (OS) were significantly higher in the haplo-HSCT group than in the chemotherapy group (74.3% vs. 47.3%;  P  =,"['patients with acute myeloid leukemia (AML) with intermediate risk (int-risk AML) who achieved first complete remission (CR1', 'Patients with Intermediate-risk Acute Myelogenous Leukemia in First Complete Remission', '443 consecutive patients ages 16-60 years with newly diagnosed  de no vo AML with int-risk cytogenetics, 147 patients with molecular int-risk AML who achieved CR1 within two courses of induction and remained in CR1 at 4 months postremission either received chemotherapy ( n  = 69) or underwent', 'patients with int-risk AML during CR1']","['pretransplant anti-thymocyte globulin (ATG) and granulocyte colony-stimulating factor (G-CSF) stimulated grafts (ATG+G-CSF', 'myeloablative HLA haploidentical hematopoietic stem cell transplantation (haplo-HSCT', 'Myeloablative Haploidentical Transplantation', 'haplo-HSCT']","['3-year leukemia-free survival (LFS) and overall survival (OS', 'cumulative incidence of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0056182', 'cui_str': 'Complement receptor CRI'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0814999', 'cui_str': 'Thymic lymphocyte'}, {'cui': 'C0009392', 'cui_str': 'Colony stimulating factor'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C4505304', 'cui_str': 'Haploidentical Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",443.0,0.0458435,The 3-year leukemia-free survival (LFS) and overall survival (OS) were significantly higher in the haplo-HSCT group than in the chemotherapy group (74.3% vs. 47.3%;  P  =,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Lan-Ping', 'Initials': 'LP', 'LastName': 'Xu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Feng-Rong', 'Initials': 'FR', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Jing-Zhi', 'Initials': 'JZ', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Chen-Hua', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Yu-Qian', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Mo', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Hong-Hu', 'Initials': 'HH', 'LastName': 'Zhu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Jin-Song', 'Initials': 'JS', 'LastName': 'Jia', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Kai-Yan', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation; Beijing, China. huangxiaojun@bjmu.edu.cn.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1637']
2468,30624371,Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension.,"BACKGROUND


Pulmonary arterial hypertension (PAH) is a chronic debilitating illness. The effects of vigorous aerobic exercise training (AET) on heart function in PAH are poorly understood.
METHODS


Eighteen women with PAH (aged 56.2 ± 8.8 yr, body mass index: 28.8 ± 7.3 kg/m) underwent 10 wk of vigorous AET. Cardiac function was observed at rest and peak exercise using bioelectrical impedance cardiography before and after the AET. Cardiac function was observed in a small PAH subset (n = 7) for 10 wk before beginning the AET. A cohort of sedentary women (n = 19) served as healthy controls.
RESULTS


Left ventricular ejection fraction (48 ± 9.2 vs 61.5 ± 13.3%, P = .034) and the systemic vascular resistance index (2258 ± 419.1 vs 2939 ± 962.4 dyn·sec/cm·m, P = .008) were lower at supine rest in the baseline PAH group versus the healthy group, as were peak exercise heart rate (140 ± 13.3 vs 170 ± 13.8 beats/min, P < .001) and systemic vascular resistance index (828 ± 141.1 vs 824 ± 300.9 dyn·sec/cm·m, P = .050) after controlling for age and heart rate. Systemic vascular resistance index measured at peak exercise decreased in the PAH group after AET (828 ± 141.1 vs 766 ± 139.6 dyn·sec/cm·m, P = .020). Left ventricular early diastolic filling ratio worsened in the PAH subset prior to AET (95.9 ± 19.4 vs 76.2 ± 18.9%, P = .043) and remained unchanged after AET.
CONCLUSION


Vigorous AET was not associated with significant declines in left ventricular systolic or diastolic function in women with PAH. Aerobic exercise training may be beneficial for reducing afterload and may preserve left ventricular diastolic function.",2019,"Systemic vascular resistance index measured at peak exercise decreased in the PAH group after AET (828 ± 141.1 vs 766 ± 139.6 dyn·sec/cm·m, P = .020).","['women with PAH', 'sedentary women (n = 19) served as healthy controls', 'Women With Pulmonary Arterial Hypertension', 'Eighteen women with PAH (aged 56.2 ± 8.8 yr, body mass index: 28.8 ± 7.3 kg/m) underwent 10 wk of vigorous AET']","['Aerobic Exercise Training', 'Aerobic exercise training', 'vigorous aerobic exercise training (AET']","['peak exercise heart rate', 'systemic vascular resistance index', 'Cardiac function', 'Systemic vascular resistance index measured at peak exercise', 'left ventricular diastolic function', 'Left ventricular early diastolic filling ratio', 'left ventricular systolic or diastolic function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",18.0,0.177276,"Systemic vascular resistance index measured at peak exercise decreased in the PAH group after AET (828 ± 141.1 vs 766 ± 139.6 dyn·sec/cm·m, P = .020).","[{'ForeName': 'Joshua G', 'Initials': 'JG', 'LastName': 'Woolstenhulme', 'Affiliation': 'Department of Rehabilitation Science, George Mason University, Fairfax, Virginia (Drs Woolstenhulme, Guccione, Herrick, Collins, and Keyser); Rehabilitation Medicine Department, Clinical Research Center, National Institutes of Health, Bethesda, Maryland (Drs Woolstenhulme, Collins, Chan, and Keyser); The Department of Physical Therapy and Health Care Sciences, The George Washington University, Washington, District of Columbia (Dr Woolstenhulme); and Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, Virginia (Dr Nathan).'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Guccione', 'Affiliation': ''}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Herrick', 'Affiliation': ''}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Leighton', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Randall E', 'Initials': 'RE', 'LastName': 'Keyser', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000397']
2469,30736030,Intraneural sensory feedback restores grip force control and motor coordination while using a prosthetic hand.,"OBJECTIVE


Tactile afferents in the human hand provide fundamental information about hand-environment interactions, which is used by the brain to adapt the motor output to the physical properties of the object being manipulated. A hand amputation disrupts both afferent and efferent pathways from/to the hand, completely invalidating the individual's motor repertoire. Although motor functions may be partially recovered by using a myoelectric prosthesis, providing functionally effective sensory feedback to users of prosthetics is a largely unsolved challenge. While past studies using invasive stimulation suggested that sensory feedback may help in handling fragile objects, none explored the underpinning, relearned, motor coordination during grasping. In this study, we aimed at showing for the first time that intraneural sensory feedback of the grip force (GF) improves the sensorimotor control of a transradial amputee controlling a myoelectric prosthesis.
APPROACH


We performed a longitudinal study testing a single subject (clinical trial registration number NCT02848846). A stacking cups test (CUP) performed over two weeks aimed at measuring the subject's ability to finely regulate the GF applied with the prosthesis. A pick and lift test (PLT), performed at the end of the study, measured the level of motor coordination, and whether the subject transferred the motor skills learned in the CUP to an alien task.
MAIN RESULTS


The results show that intraneural sensory feedback increases the subject's ability in regulating the GF and allows for improved performance over time. Additionally, the PLT demonstrated that the subject was able to generalize and transfer her manipulation skills to an unknown task and to improve her motor coordination.
SIGNIFICANCE


Our findings suggest that intraneural sensory feedback holds the potential of restoring functionally effective tactile feedback. This opens up new possibilities to improve the quality of life of amputees using a neural prosthesis.",2019,The results show that intraneural sensory feedback increases the subject's ability in regulating the GF and allows for improved performance over time.,[],['grip force (GF'],[],[],"[{'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",[],,0.0197129,The results show that intraneural sensory feedback increases the subject's ability in regulating the GF and allows for improved performance over time.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Clemente', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Valle', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Controzzi', 'Affiliation': ''}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Strauss', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Iberite', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stieglitz', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Granata', 'Affiliation': ''}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Rossini', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Petrini', 'Affiliation': ''}, {'ForeName': 'Silvestro', 'Initials': 'S', 'LastName': 'Micera', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cipriani', 'Affiliation': ''}]",Journal of neural engineering,['10.1088/1741-2552/ab059b']
2470,30811541,Attenuation of Weight Loss Through Improved Antilipolytic Effect in Adipose Tissue Via the SGLT2 Inhibitor Tofogliflozin.,"CONTEXT


Although calorie loss from increased urinary glucose excretion continues after long-term treatment with sodium-glucose cotransporter 2 inhibitors (SGLT2is), the mechanisms of the attenuated weight loss due to SGLT2is are not well known.
OBJECTIVE


To examine the mechanism of the attenuated weight loss during long-term treatment with an SGLT2i, tofogliflozin, focusing on the antilipolytic effect of insulin on adipose tissue.
DESIGN AND PARTICIPANTS


An integrated analysis was performed using data from two phase 3 studies of 52 weeks of tofogliflozin administration. The antilipolytic effect was evaluated using adipose tissue insulin resistance (Adipo-IR) calculated from the product of the levels of fasting insulin (f-IRI) and fasting free fatty acids (f-FFAs).
RESULTS


Data from 774 patients with type 2 diabetes (mean age, 58.5 years; glycosylated hemoglobin, 8.1%; body mass index, 25.6 kg/m2; estimated glomerular filtration rate, 83.9 mL/min/1.73m2; 66% men) were analyzed. Weight loss plateaued between weeks 24 and 52 after decreasing significantly. f-IRI levels decreased significantly from baseline to week 24, and the decrease was maintained until Week 52. f-FFA levels significantly increased, peaked at week 24, then declined from weeks 24 to 52. Adipo-IR levels declined progressively throughout the 52 weeks (-3.6 mmol/L·pmol/L and -6.2 mmol/L·pmol/L at weeks 24 and 52, respectively; P < 0.001 baseline vs weeks 24 and 52 and week 24 vs week 52). Higher baseline Adipo-IR levels were independently associated with greater weight loss at week 52.
CONCLUSION


The improved antilipolytic effect in adipose tissue may attenuate progressive lipolysis, leading to attenuating future weight loss induced by an SGLT2i in patients with type 2 diabetes.",2019,"Adipo-IR levels declined progressively throughout the 52 weeks (-3.6 mmol/L·pmol/L and -6.2 mmol/L·pmol/L at weeks 24 and 52, respectively; P < 0.001 baseline vs weeks 24 and 52 and week 24 vs week 52).","['patients with type 2 diabetes', '774 patients with type 2 diabetes (mean age, 58.5 years; glycosylated hemoglobin, 8.1%; body mass index, 25.6 kg/m2; estimated glomerular filtration rate, 83.9 mL/min/1.73m2; 66% men']","['tofogliflozin', 'SGLT2i, tofogliflozin']","['fasting insulin (f-IRI) and fasting free fatty acids (f-FFAs', 'f-IRI levels', 'Weight loss plateaued', 'adipose tissue insulin resistance (Adipo-IR', 'weight loss', 'f-FFA levels', 'Adipo-IR levels', 'Higher baseline Adipo-IR levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",774.0,0.0251827,"Adipo-IR levels declined progressively throughout the 52 weeks (-3.6 mmol/L·pmol/L and -6.2 mmol/L·pmol/L at weeks 24 and 52, respectively; P < 0.001 baseline vs weeks 24 and 52 and week 24 vs week 52).","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nojima', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Department, Kowa Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of General Internal Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02254']
2471,30992306,Pharmacokinetic Interaction between Naloxone and Naltrexone Following Intranasal Administration to Healthy Subjects.,"Naloxone (17-allyl-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one HCl), a  μ -opioid receptor antagonist, is administered intranasally to reverse an opioid overdose but its short half-life may necessitate subsequent doses. The addition of naltrexone [17-(cyclopropylmethyl)-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one], another  μ -receptor antagonist, which has a reported half-life of 3 1/2 hours, may extend the available time to receive medical treatment. In a phase 1 pharmacokinetic study, healthy adults were administered naloxone and naltrexone intranasally, separately and in combination. When administered with naloxone, the  C   max  value of naltrexone decreased 62% and the area under the concentration-time curve from time zero to infinity (AUC 0-inf ) decreased 38% compared with when it was given separately; lower concentrations of naltrexone were observed as early as 5 minutes postdose. In contrast, the  C   max  and AUC 0-inf  values of naloxone decreased only 18% and 16%, respectively, when given with naltrexone. This apparent interaction was investigated further to determine if naloxone and naltrexone shared a transporter. Neither compound was a substrate for organic cation transporter (OCT) 1, OCT2, OCT3, OCTN1, or OCTN2. There was no evidence of the involvement of a transmembrane transporter when they were tested separately or in combination at concentrations of 10 and 500  µ M using Madin-Darby canine kidney II cell monolayers at pH 7.4. The efflux ratios of naloxone and naltrexone increased to six or greater when the apical solution was pH 5.5, the approximate pH of the nasal cavity; there was no apparent interaction when the two were coincubated. The importance of understanding how opioid antagonists are absorbed by the nasal epithelium is magnified by the rise in overdose deaths attributed to long-lived synthetic opioids and the realization that better strategies are needed to treat opioid overdoses.",2019,"Neither compound was a substrate for organic cation transporter (OCT) 1, OCT2, OCT3, OCTN1, or OCTN2.","['healthy adults', 'Healthy Subjects']","['naltrexone', 'naloxone and naltrexone', 'Naloxone and Naltrexone', 'naltrexone [17-(cyclopropylmethyl)-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one', 'naloxone', 'Naloxone (17-allyl-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one HCl']","['C   max  and AUC 0-inf  values of naloxone', 'Pharmacokinetic Interaction', 'efflux ratios of naloxone and naltrexone']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",,0.0261451,"Neither compound was a substrate for organic cation transporter (OCT) 1, OCT2, OCT3, OCTN1, or OCTN2.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Krieter', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, Bethesda, Maryland (P.K., C.N.C., S.G., P.S.); and Sekisui XenoTech, LLC, Kansas City, Kansas (R.S.) philip.krieter@nih.gov.'}, {'ForeName': 'C Nora', 'Initials': 'CN', 'LastName': 'Chiang', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, Bethesda, Maryland (P.K., C.N.C., S.G., P.S.); and Sekisui XenoTech, LLC, Kansas City, Kansas (R.S.).'}, {'ForeName': 'Shwe', 'Initials': 'S', 'LastName': 'Gyaw', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, Bethesda, Maryland (P.K., C.N.C., S.G., P.S.); and Sekisui XenoTech, LLC, Kansas City, Kansas (R.S.).'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Skolnick', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, Bethesda, Maryland (P.K., C.N.C., S.G., P.S.); and Sekisui XenoTech, LLC, Kansas City, Kansas (R.S.).'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, Bethesda, Maryland (P.K., C.N.C., S.G., P.S.); and Sekisui XenoTech, LLC, Kansas City, Kansas (R.S.).'}]",Drug metabolism and disposition: the biological fate of chemicals,['10.1124/dmd.118.085977']
2472,31028057,Indinavir Increases Midazolam  N -Glucuronidation in Humans: Identification of an Alternate CYP3A Inhibitor Using an In Vitro to In Vivo Approach.,"Midazolam is a widely used index substrate for assessing effects of xenobiotics on CYP3A activity. A previous study involving human hepatocytes showed the primary route of midazolam metabolism, 1'-hydroxylation, shifted to  N -glucuronidation in the presence of the CYP3A inhibitor ketoconazole, which may lead to an overprediction of the magnitude of a xenobiotic-midazolam interaction. Because ketoconazole is no longer recommended as a clinical CYP3A inhibitor, indinavir was selected as an alternate CYP3A inhibitor to evaluate the contribution of the  N -glucuronidation pathway to midazolam metabolism. The effects of indinavir on midazolam 1'-hydroxylation and  N -glucuronidation were first characterized in human-derived in vitro systems. Compared with vehicle, indinavir (10  μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50  obtained with hepatocytes (2.7  μ M) was within reported human unbound indinavir C max  (≤5  μ M). Midazolam  N -glucuronidation in hepatocytes increased in the presence of indinavir in both a concentration-dependent (1-33  μ M) and time-dependent (0-4 hours) manner (by up to 2.5-fold), prompting assessment in human volunteers ( n  = 8). As predicted by these in vitro data, indinavir was a strong inhibitor of the 1'-hydroxylation pathway, decreasing the 1'-hydroxymidazolam/midazolam area under the plasma concentration versus time curve (AUC) 0-12h  ratio by 80%. Although not statistically significant, the midazolam  N -glucuronide/midazolam AUC 0-12h  ratio increased by 40%, suggesting a shift to the  N -glucuronidation pathway. The amount of midazolam  N -glucuronide recovered in urine increased 4-fold but remained <10% of the oral midazolam dose (2.5 mg). A powered clinical study would clarify whether  N -glucuronidation should be considered when assessing the magnitude of a xenobiotic-midazolam interaction.",2019,"Compared with vehicle, indinavir (10  μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50  obtained with hepatocytes (2.7  μ M) was within reported human unbound indinavir C max  (≤5  μ M).",['N -Glucuronidation in Humans'],"['Midazolam', 'ketoconazole', 'oral midazolam', 'vehicle, indinavir', 'Indinavir', 'indinavir']","['amount of midazolam  N -glucuronide recovered in urine', 'midazolam  N -glucuronide/midazolam AUC 0-12h  ratio']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0376637', 'cui_str': 'Indinavir'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456695', 'cui_str': '/12h'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0362997,"Compared with vehicle, indinavir (10  μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50  obtained with hepatocytes (2.7  μ M) was within reported human unbound indinavir C max  (≤5  μ M).","[{'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Leonowens', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Pérez', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Kosea S', 'Initials': 'KS', 'LastName': 'Frederick', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Yolanda V', 'Initials': 'YV', 'LastName': 'Scarlett', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fisher', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Paine', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.) mary.paine@wsu.edu.'}]",Drug metabolism and disposition: the biological fate of chemicals,['10.1124/dmd.119.087007']
2473,31075171,Contribution of Functional Antimalarial Immunity to Measures of Parasite Clearance in Therapeutic Efficacy Studies of Artemisinin Derivatives.,"BACKGROUND


Antibodies to the blood stages of malaria parasites enhance parasite clearance and antimalarial efficacy. The antibody subclass and functions that contribute to parasite clearance during antimalarial treatment and their relationship to malaria transmission intensity have not been characterized.
METHODS


Levels of immunoglobulin G (IgG) subclasses and C1q fixation in response to Plasmodium falciparum merozoite antigens (erythrocyte-binding antigen [EBA] 175RIII-V, merozoite surface protein 2 [MSP-2], and MSP-142) and opsonic phagocytosis of merozoites were measured in a multinational trial assessing the efficacy of artesunate therapy across 11 Southeast Asian sites. Regression analyses assessed the effects of antibody seropositivity on the parasite clearance half-life (PC½), having a PC½ of ≥5 hours, and having parasitemia 3 days after treatment.
RESULTS


IgG3, followed by IgG1, was the predominant IgG subclass detected (seroprevalence range, 5%-35% for IgG1 and 27%-41% for IgG3), varied across study sites, and was lowest in study sites with the lowest transmission intensity and slowest mean PC½. IgG3, C1q fixation, and opsonic-phagocytosis seropositivity were associated with a faster PC½ (range of the mean reduction in PC½, 0.47-1.16 hours; P range, .001-.03) and a reduced odds of having a PC½ of ≥5 hours and having parasitemia 3 days after treatment.
CONCLUSIONS


The prevalence of IgG3, complement-fixing antibodies, and merozoite phagocytosis vary according to transmission intensity, are associated with faster parasite clearance, and may be sensitive surrogates of an augmented clearance capacity of infected erythrocytes. Determining the functional immune mechanisms associated with parasite clearance will improve characterization of artemisinin resistance.",2019,"The prevalence of IgG3, complement-fixing antibodies, and merozoite phagocytosis vary according to transmission intensity, are associated with faster parasite clearance, and may be sensitive surrogates of an augmented clearance capacity of infected erythrocytes.",['11 Southeast Asian sites'],"['artesunate therapy', 'immunoglobulin G (IgG) subclasses and C1q fixation', 'Artemisinin Derivatives']","['lowest transmission intensity and slowest mean PC½. IgG3, C1q fixation, and opsonic-phagocytosis seropositivity', 'parasite clearance half-life (PC½), having a PC½ of ≥5 hours, and having parasitemia 3 days']","[{'cui': 'C0238697', 'cui_str': 'South East Asian'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020859', 'cui_str': 'Immunoglobulin IgG3'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0357242,"The prevalence of IgG3, complement-fixing antibodies, and merozoite phagocytosis vary according to transmission intensity, are associated with faster parasite clearance, and may be sensitive surrogates of an augmented clearance capacity of infected erythrocytes.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Flaherty"", 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ataíde', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Sophie G', 'Initials': 'SG', 'LastName': 'Zaloumis', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ashley', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Powell', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Gaoqian', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Reiling', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Pharath', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Faculty of Tropical Medicine, Mahidol University, Bangkok.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Htut', 'Affiliation': 'Department of Medical Research, Yangon, Myanmar.'}, {'ForeName': 'Mayfong', 'Initials': 'M', 'LastName': 'Mayxay', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, United Kingdom.'}, {'ForeName': 'M Abul', 'Initials': 'MA', 'LastName': 'Faiz', 'Affiliation': 'Malaria Research Group, Chittagong, Bangladesh.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nosten', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Melbourne, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok.'}, {'ForeName': 'Freya J I', 'Initials': 'FJI', 'LastName': 'Fowkes', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz247']
2474,31169293,"Stockpiled Avian Influenza A(H7N9) Vaccines Induce Robust, Nonneutralizing Functional Antibodies Against Antigenically Drifted Fifth-Wave A(H7N9) Viruses.","Human infections caused by avian influenza A(H7N9) viruses have raised concerns of a pandemic. The capability of the current stockpiled A(H7N9) vaccines to induce cross-protective, nonneutralizing functional antibodies against antigenically drifted A(H7N9) viruses has not been evaluated before. Here we show that vaccination with either MF59- or AS03-adjuvanted inactivated A(H7N9) vaccines elicited robust, cross-reactive antibody-dependent cell-mediated cytotoxicity-mediating and neuraminidase-inhibiting functional antibodies against the antigenically drifted A(H7N9) viruses that emerged recently during the fifth-wave outbreak in China, including a highly pathogenic A(H7N9) human isolate. Such cross-reactive humoral immunity may provide vital first-line defense against fatal outcomes in case of an A(H7N9) pandemic.",2019,"The capability of the current stockpiled A(H7N9) vaccines to induce cross-protective, nonneutralizing functional antibodies against antigenically drifted A(H7N9) viruses has not been evaluated before.",[],['Stockpiled Avian Influenza A(H7N9'],[],[],"[{'cui': 'C0016627', 'cui_str': 'Avian influenza'}]",[],,0.0167952,"The capability of the current stockpiled A(H7N9) vaccines to induce cross-protective, nonneutralizing functional antibodies against antigenically drifted A(H7N9) viruses has not been evaluated before.","[{'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz295']
2475,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES


Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS


Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS


Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS


The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS


Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
2476,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES


Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery.
STUDY DESIGN


A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions).
RESULTS


There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051).
CONCLUSIONS


Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014']
2477,32460138,Social timing influences sleep quality in patients with sleep disorders.,"OBJECTIVES


We aimed to compare three variants of the Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ) and to assess whether chronotype (MSF sc )/social jetlag (SJL) are associated with sleep quality in patients with sleep disorders (SD).
METHODS


In sum, 431 SD patients and 338 subjects from the general population (GP) were included. Participants filled in three variants of the PSQI and the Munich ChronoType Questionnaire (MCTQ). We used Generalized Estimating Equations (GEE) to investigate effects of group (GP, SD), PSQI (usual, work or free) and their interaction (group∗PSQI) on scores. To investigate associations between MSF sc /SJL and the difference between PSQI w  and PSQI f  (PSQI diff ) in patients with SD we used linear regressions (N = 352). We used Sobel to test whether there was a mediation effect of SJL on the association between MSF sc  and PSQI diff .
RESULTS


PSQI scores differed between groups (p < 0.001). Post-hoc analysis revealed a significant difference between PSQI u  vs. PSQI f  and PSQI w  vs. PSQI f  with PSQI f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group. In line with previous findings, SJL was associated to PSQI diff  in SD patients.
CONCLUSIONS


PSQI u  mainly represents sleep quality on workdays also in SD patients. Being a late chronotype seems to be associated with higher differences in sleep quality on work-vs. free days mostly when it coincides with societal time constraints. Since sleep quality is poorer on workdays even in SD patients, we suggest that treatment strategies should address social aspects affecting sleep, including ways of minimizing SJL.",2020,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","['patients with sleep disorders (SD', 'patients with SD', 'patients with sleep disorders', '431 SD patients and 338 subjects from the general population (GP) were included', 'SD patients']","['chronotype (MSF sc )/social jetlag (SJL', 'MSF sc /SJL', 'PSQI', 'SJL']","['PSQI (usual, work or free) and their interaction (group∗PSQI) on scores', 'PSQI u  vs. PSQI f  and PSQI w  vs. PSQI', 'Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ', 'PSQI scores', 'Munich ChronoType Questionnaire (MCTQ', 'sleep quality', 'PSQI w  and PSQI f  (PSQI diff ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0284205,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","[{'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Reis', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; IMM - Faculty of Medicine João Lobo Antunes, University of Lisbon, Portugal.'}, {'ForeName': 'Luísa K', 'Initials': 'LK', 'LastName': 'Pilz', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Laboratório de Cronobiologia e Sono, HCPA/UFRGS, Porto Alegre, RS, Brazil; PPG em Psiquiatria e Ciências do Comportamento, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lena Katharina', 'Initials': 'LK', 'LastName': 'Keller', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Department of Child and Adolescent Psychiatry, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paiva', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; CHRC - Nova Medical School - Faculdade de Ciências Médicas, Lisbon, Portugal.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Roenneberg', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany. Electronic address: roenneberg@lmu.de.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.019']
2478,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND


Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary.
OBJECTIVE


To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning.
METHODS


A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied.
RESULTS


Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months.
CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929']
2479,32460179,Preclinical profile and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-resistant prostate cancer.,"PURPOSE


We conducted preclinical experiments and phase I clinical trial to investigate the safety, pharmacokinetics (PK) and antitumour effects of GT0918 in castration-resistant prostate cancer (CRPC).
EXPERIMENTAL DESIGN


An androgen receptor (AR) competitive binding assay was performed, followed by evaluation of GT0918 on AR protein expression. The efficacy of GT0918 was investigated in a castration-resistant xenograft model. A phase I dose-escalation study of GT0918 in CRPC was also carried out to evaluate its safety, PK and antitumour efficacy.
RESULTS


GT0918 was demonstrated to inhibit the binding of androgen to AR more potently than MDV3100, and to effectively reduce the AR protein level. GT0918 inhibited the transcriptional activity of wild-type AR and AR with clinically relevant ligand-binding domain mutations. Furthermore, GT0918 significantly inhibited the growth of prostate cancer. A total of 16 patients was treated with GT0918 at five dose levels. Among these 16 patients, 10 and 2 patients, respectively, completed a three-cycle and six-cycle treatment, in which MTD was not reached. All the treatment-related adverse events were grade I, including hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia. PK parameters showed that drug exposure increased with dose proportionally from 50 to 300 mg and a saturation was observed between 300 and 400 mg. PSA declines of ≥30% and ≥50% were, respectively, observed in six and two cases. All the 12 patients with metastatic soft tissue lesions confirmed stable disease.
CONCLUSIONS


GT0918, a full AR antagonist without agonist effect, has high binding affinity to AR with AR protein down-regulation activity. GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC. CLINICALTRIALS: gov identifier CTR20150501.",2020,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"['castration-resistant prostate cancer (CRPC', 'castration-resistant prostate cancer', '12 patients with metastatic soft tissue lesions confirmed stable disease']",['novel androgen receptor antagonist GT0918'],"['safety, pharmacokinetics (PK) and antitumour effects', 'growth of prostate cancer', 'PSA declines', 'AR protein level', 'safety, PK\xa0and antitumour efficacy', 'transcriptional activity of wild-type AR and AR', 'hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia']","[{'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}, {'cui': 'C4043276', 'cui_str': 'GT0918'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",16.0,0.014045,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"[{'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fubo', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qianxiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Chunyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China. Electronic address: cychen@kintor.com.cn.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: sunyhsmmu@126.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.013']
2480,32460220,Ultrasound imaging evaluation of structural and textural features in asymptomatic achilles tendons in pre-professional dancers: A cross-sectional study.,"OBJECTIVE


To evaluate performance descriptors, sociodemographics variables and tendon echogenicity of asymptomatic Achilles tendons and to compare the echotexture from different classification subgroups.
DESIGN


A prospective, randomized cross-sectional study was carried out.
SETTING


laboratory of university.
PARTICIPANTS


Forty-two Achilles tendons (AT) were recruited from pre-professional dancers. Based on the echogenicity pattern, the sample was divided into two groups (n = 21, Heterogeneous group; n = 21, Homogeneous group).
MAIN OUTOCOME MEASURES


Ultrasound images and ImageJ measurements were performed to evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test were measured as performance parameter.
RESULTS


EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups. AT-TH, endurance test, balance test, years of dance, training hours per week and average pointe hours per week did not showed differences between groups. A multivariate prediction model between groups and the echotexture variables (EI (R 2  = 0.569; EV (R 2  = 0.341)) were determined.
CONCLUSION


Asymptomatic AT of heterogeneous group showed a lower EI and a higher EV compared to homogeneous group. Tendon echogenicity did not interact with performance variables.",2020,"RESULTS


EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","['laboratory of university', 'Forty-two Achilles tendons (AT) were recruited from pre-professional dancers', 'asymptomatic achilles tendons in pre-professional dancers']",[],"['evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test', 'Tendon echogenicity']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.0279145,"RESULTS


EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: irebargar@gmail.com.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Almazán-Polo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: jaime.almazan@universidadeuropea.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Jaén-Crespo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: gjaencrespo@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.05.008']
2481,32460239,The Impact of a Dairy Milk Recovery Beverage on Bacterially Stimulated Neutrophil Function and Gastrointestinal Tolerance in Response to Hypohydration Inducing Exercise Stress.,"The study aimed to determine the impact of a dairy milk recovery beverage immediately after endurance exercise on leukocyte trafficking, neutrophil function, and gastrointestinal tolerance markers during recovery. Male runners (N = 11) completed two feeding trials in randomized order, after 2 hr of running at 70% V˙O2max, fluid restricted, in temperate conditions (25 °C, 43% relative humidity). Immediately postexercise, the participants received a chocolate-flavored dairy milk beverage equating to 1.2 g/kg body mass carbohydrate and 0.4 g/kg body mass protein in one trial, and water volume equivalent in another trial. Venous blood and breath samples were collected preexercise, postexercise, and during recovery to determine the leukocyte counts, plasma intestinal fatty acid binding protein, and cortisol concentrations, as well as breath H2. In addition, 1,000 µl of whole blood was incubated with 1 μg/ml Escherichia coli lipopolysaccharide for 1 hr at 37 °C to determine the stimulated plasma elastase concentration. Gastrointestinal symptoms and feeding tolerance markers were measured preexercise, every 15 min during exercise, and hourly postexercise for 3 hr. The postexercise leukocyte (mean [95% confidence interval]: 12.7 [11.6, 14.0] × 109/L [main effect of time, MEOT]; p < .001) and neutrophil (10.2 [9.1, 11.5] × 109/L; p < .001) counts, as well as the plasma intestinal fatty acid binding protein (470 pg/ml; +120%; p = .012) and cortisol (236 nMol/L; +71%; p = .006) concentrations, were similar throughout recovery for both trials. No significant difference in breath H2 and gastrointestinal symptoms was observed between trials. The total (Trial × Time, p = .025) and per cell (Trial × Time, p = .001) bacterially stimulated neutrophil elastase release was greater for the chocolate-flavored dairy milk recovery beverage (+360% and +28%, respectively) in recovery, compared with the water trial (+85% and -38%, respectively). Chocolate-flavored dairy milk recovery beverage consumption immediately after exercise prevents the decrease in neutrophil function during the recovery period, and it does not account for substantial malabsorption or gastrointestinal symptoms over a water volume equivalent.",2020,"The total (Trial × Time, p = .025) and per cell (Trial × Time, p = .001) bacterially stimulated neutrophil elastase release was greater for the chocolate-flavored dairy milk recovery beverage (+360% and +28%, respectively) in recovery, compared with the water trial (+85% and -38%, respectively).",['Male runners (N = 11'],"['dairy milk recovery beverage immediately after endurance exercise', 'chocolate-flavored dairy milk beverage equating to 1.2\xa0g/kg body mass carbohydrate and 0.4\xa0g/kg body mass protein', 'Dairy Milk Recovery Beverage', 'ml Escherichia coli lipopolysaccharide']","['postexercise leukocyte', 'leukocyte trafficking, neutrophil function, and gastrointestinal tolerance markers', 'neutrophil elastase release', 'neutrophil function', 'Gastrointestinal symptoms and feeding tolerance markers', 'Venous blood and breath samples', 'plasma intestinal fatty acid binding protein', 'breath H2 and gastrointestinal symptoms', 'neutrophil', 'leukocyte counts, plasma intestinal fatty acid binding protein, and cortisol concentrations, as well as breath H2']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.144653,"The total (Trial × Time, p = .025) and per cell (Trial × Time, p = .001) bacterially stimulated neutrophil elastase release was greater for the chocolate-flavored dairy milk recovery beverage (+360% and +28%, respectively) in recovery, compared with the water trial (+85% and -38%, respectively).","[{'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Monash University.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Camões-Costa', 'Affiliation': 'Monash University.'}, {'ForeName': 'Rhiannon M J', 'Initials': 'RMJ', 'LastName': 'Snipe', 'Affiliation': 'Deakin University.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Writtle University College.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': 'Monash University.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Huschtscha', 'Affiliation': 'Monash University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2019-0349']
2482,32460241,New Zealand Blackcurrant Extract Enhances Muscle Oxygenation During Forearm Exercise in Intermediate-Level Rock Climbers.,"The delivery to and utilization of oxygenated hemoglobin to the forearm muscles are key determinants of rock-climbing performance. Anthocyanin-rich New Zealand blackcurrant (NZBC) has been suggested to improve blood flow and may enhance forearm endurance performance. As such, a double-blind, randomized crossover design study with 12 participants performed submaximal intermittent contractions (at 40% maximal voluntary contraction) to failure after a 7-day intake of 600 mg/day NZBC extract or placebo. Minimum tissue saturation index (TSI%) was assessed during the contractions. During recovery, time to half recovery of TSI% and brachial artery blood flow were assessed. There was no difference in time to exhaustion between NZBC and placebo. Minimum TSI% was lower with NZBC extract (43 ± 8 vs. 50 ± 11 TSI%; p = .007; Cohen's d = 1.01). During recovery, there was no effect on brachial artery blood flow. However, time to half recovery was faster with NZBC (26 ± 17 vs. 42 ± 26 s; p = .001; Cohen's d = 1.3) following exhaustive contractions. Seven days of NZBC extract appears to improve muscle oxygenation during and following contractions with no change in either arterial blood flow or forearm endurance performance.",2020,Seven days of NZBC extract appears to improve muscle oxygenation during and following contractions with no change in either arterial blood flow or forearm endurance performance.,['12 participants performed'],"['New Zealand Blackcurrant Extract', 'submaximal intermittent contractions', 'Anthocyanin-rich New Zealand blackcurrant (NZBC', 'NZBC extract or placebo', 'NZBC extract', 'placebo']","['brachial artery blood flow', 'Minimum tissue saturation index (TSI', 'arterial blood flow or forearm endurance performance', 'Muscle Oxygenation', 'time to exhaustion', 'Minimum TSI', 'time to half recovery of TSI% and brachial artery blood flow', 'time to half recovery', 'muscle oxygenation', 'forearm endurance performance', 'blood flow']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040139', 'cui_str': 'Thyroid stimulating immunoglobulins'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",12.0,0.245025,Seven days of NZBC extract appears to improve muscle oxygenation during and following contractions with no change in either arterial blood flow or forearm endurance performance.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'University of Gloucestershire.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Paterson', 'Affiliation': 'University of Gloucestershire.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gloster', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Potter', 'Affiliation': 'University of Chichester.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2019-0365']
2483,32460243,Performance on an Associative Memory Test Decreases 8 hr After Cardiovascular Exercise.,"This study was designed to assess the effects of acute exercise on performance of a paired associate learning (PAL) test, an operationalization of hippocampal-dependent associative memory. Participants performed a PAL test and then ran on a treadmill (exercise group, n = 52) or solved Sudoku puzzles (control group, n = 54). Participants returned 2, 5, or 8 hr later to perform a second, different, PAL test. PAL scores for the control group did not change over time. Similarly, scores on tests taken 2 and 5 hr after exercise were not different from baseline or control data. Scores on tests taken 8 hr after exercise, however, fell significantly below baseline (by 8.6%) and control (by 9.8%) scores. These data demonstrate that acute exercise can negatively affect the encoding and retrieval of new information even hours after the exercise bout, which should be a consideration when designing exercise programs to enhance, and not hinder, learning.",2020,"Scores on tests taken 8 hr after exercise, however, fell significantly below baseline (by 8.6%) and control (by 9.8%) scores.",[],"['PAL test and then ran on a treadmill (exercise group, n = 52) or solved Sudoku puzzles (control', 'acute exercise']",['PAL scores'],[],"[{'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",54.0,0.0245787,"Scores on tests taken 8 hr after exercise, however, fell significantly below baseline (by 8.6%) and control (by 9.8%) scores.","[{'ForeName': 'Arth R R', 'Initials': 'ARR', 'LastName': 'Pahwa', 'Affiliation': 'University of Alberta.'}, {'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Miller', 'Affiliation': 'University of Alberta.'}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Caplan', 'Affiliation': 'University of Alberta.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Collins', 'Affiliation': 'University of Alberta.'}]",Journal of sport & exercise psychology,['10.1123/jsep.2019-0224']
2484,32460297,"The Effect of Perineal Warm Application on Perineal Pain, Perineal Integrity, and Postpartum Comfort in the Second Stage of Labor: Randomized Clinical Trial.","BACKGROUND


Protection of perineum and reduction of perineal pain is important in the second stage of labor.
AIM


The aim of this study was to determine the effect of perineal warm application on perineal pain, perineal integrity, and postnatal comfort in the second stage of labor.
METHODS


A single blind randomized and controlled experimental study was conducted with a total of 100 primiparous pregnant women in the warm application (n = 50) and control groups (n = 50). The warm application group was given a damp and warm application to the perineal region during the second stage of labor and only the standard midwifery care was given to the control group. Pregnant Introductory Form was used in the collection of data. Perineal pain level was measured prior to and after the intervention, after delivery, and 2 h from delivery by means of Visual Analogue Scale. In the postpartum period, the perineal condition was evaluated by the midwife with Questionnaire to Determine the Perineal Condition. Two hours from the delivery, Postpartum Comfort Questionnaire was used to determine the comfort level of the women.
RESULTS


It was found that there was a decrease in the pain levels of the warm application group compared to pre-intervention pain levels (p < 0.0001). When the warm application and control groups were compared, we found statistically significant differences between the pain levels immediately after the intervention (perineal pain: 8.54 ± 1.38 vs. 9.56 ± 0.57, p < 0.0001), after delivery (perineal pain: 2.20 ± 1.72 vs. 3.64 ± 2.07, p < 0.0001), and 2 h after delivery (perineal pain: 0.30 ± 0.78 vs. 0.68 ± 0.98, p = 0.028). In the study, the intactness of perineum was found to be significantly higher in the warm application group compared to the control group (p = 0.003). The suture need for perinea was significantly higher in the control group than in the warm application group (p = 0.016). In the study, the physical comfort level of the warm application group was found to be significantly higher than the control group (56.06 ± 4.61 vs. 54.30 ± 4.73, p = 0.012).
CONCLUSIONS


In the second stage of labor, it was found that the application of warmth decreases perineal pain, maintains the perineal integrity, and improves postpartum comfort.",2020,It was found that there was a decrease in the pain levels of the warm application group compared to pre-intervention pain levels (p < 0.0001).,['100 primiparous pregnant women in the warm application (n = 50) and control groups (n = 50'],"['Perineal Warm Application', 'perineal warm application']","['Perineal Pain, Perineal Integrity, and Postpartum Comfort', 'perineal pain, perineal integrity, and postnatal comfort', 'suture need for perinea', 'perineal condition', 'Perineal pain level', 'pain levels', 'intactness of perineum', 'physical comfort level', 'postpartum comfort', 'comfort level of the women']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",100.0,0.0276625,It was found that there was a decrease in the pain levels of the warm application group compared to pre-intervention pain levels (p < 0.0001).,"[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Türkmen', 'Affiliation': 'Department of Midwifery, School of Health, Balıkesir University, Balıkesir, Turkey, hulyayurter@hotmail.com.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Çetinkaya', 'Affiliation': 'Atatürk City Hospital, Delivery Room, Balıkesir, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Apay', 'Affiliation': 'Atatürk City Hospital, Delivery Room, Balıkesir, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Karamüftüoğlu', 'Affiliation': 'Atatürk City Hospital, Delivery Room, Balıkesir, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Kılıç', 'Affiliation': 'Atatürk City Hospital, Delivery Room, Balıkesir, Turkey.'}]",Complementary medicine research,['10.1159/000507605']
2485,32460315,Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial.,"Purpose


To compare changes in relative peripheral refraction (RPR) associated with myopia progression in myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses over 2 years.
Methods


A 2-year double-blind, randomized controlled trial was conducted on 183 myopic children. Subjects were allocated to either wearing DIMS (n = 93) or SV spectacle lenses (n = 90). Peripheral refraction at 10°, 20°, and 30° of the nasal (10N, 20N, 30N) and temporal (10T, 20T, 30T) retinal eccentricities, central refraction, and axial length after cycloplegia were monitored every 6 months.
Results


DIMS group showed symmetrical peripheral myopic shifts between the nasal and temporal retina (comparing myopic shifts between the nasal and temporal retina, the difference between the corresponding eccentricities were nonclinically significance). SV group showed asymmetrical peripheral myopic shifts between the nasal and temporal retina, with more myopic shifts (all P ≤ 0.001) at 10T (-0.32 ± 0.62 diopters [D]), at 20T (-0.69 ± 0.95 D), and 30T (-0.85 ± 1.52 D). No significant changes in RPR spherical equivalent (M) were noted in the DIMS group, whereas significant increases (all P < 0.0001) in hyperopic RPR M were observed at 10N (0.27 ± 0.45 D), 20N (0.75 ± 0.72 D), and 30N (0.98 ± 0.76 D) in the SV group.
Conclusions


Wearing DIMS lenses resulted in a significantly different peripheral refraction profile and RPR changes, as well as significant myopia control effects when compared with SV lenses. Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.",2020,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","['183 myopic children', 'myopic children wearing Defocus Incorporated']","['Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses', 'wearing DIMS', 'SV spectacle lenses']","['symmetrical peripheral myopic shifts', '30T) retinal eccentricities, central refraction, and axial length after cycloplegia', 'RPR spherical equivalent (M', 'peripheral refraction and slowed central myopia progression', 'hyperopic RPR M', 'relative peripheral refraction (RPR', 'Peripheral refraction', 'peripheral refraction profile and RPR changes', 'asymmetrical peripheral myopic shifts', 'Relative Peripheral Refraction', 'myopia control effects']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",183.0,0.154496,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","[{'ForeName': 'Han Yu', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ',.'}, {'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': ',.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': ',.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': ',.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.5.53']
2486,32460396,Effects of Photobiomodulation with Low-Level Laser Therapy in Burning Mouth Syndrome: A randomized clinical trial.,"BACKGROUND


Photobiomodulation has proven to be effective in different painful conditions.
OBJECTIVES


To assess the effect of photobiomodulation for pain management in burning mouth syndrome (BMS) patients, besides analysing the impact on different aspects of quality of life.
METHODS


A randomized, single blind, clinical trial was performed among 20 patients with BMS. Photobiomodulation was applied in the study group (n=10) with a dose of 12 J/cm 2  during 10 sessions, comparing with a placebo group (n=10) with the laser turned off. Pain was assessed using the visual analogue scale (VAS) before starting each treatment session, and at the 1-month and 4-month follow-up appointments. Some validated questionnaires for general health were also complete: SF-36, OHIP-14, Epworth, SCL 90-R and McGill.
RESULTS


All patients (n=10) in the study group improved their pain ending treatment and remaining among 90% (n=9) in the 4-month follow-up. Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups.
CONCLUSIONS


Photobiomodulation seems to be effective in reducing pain in patients with BMS, as well as, having a positive impact on the psychological state of these patients.",2020,"Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups.
","['burning mouth syndrome (BMS) patients', '20 patients with BMS', 'patients with BMS', 'Burning Mouth Syndrome']","['photobiomodulation', 'Photobiomodulation with Low-Level Laser Therapy', 'placebo']","['pain ending treatment', 'visual analogue scale (VAS', 'Pain', 'McGill questionnaire, Epworth scale, and SCL 90-R', 'pain']","[{'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}]",20.0,0.0644223,"Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Pedro', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED research group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'López-Pintor', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED research group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Casañas', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED research group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED research group, School of Dentistry, Complutense University, Madrid, Spain.'}]",Oral diseases,['10.1111/odi.13443']
2487,32460414,The Effects of Home Noninvasive Ventilation on The Quality Of Life and Physiological Parameters of Patients with Chronic Respiratory Failure.,"INTRODUCTION


Home noninvasive mechanical ventilation (HNIV) in patients with chronic hypercapnic respiratory failure (CHRF) may improve the health related quality of life (HRQL) and reduce hospitalizations.
OBJECTIVE


To determine the effects of HNIV on HRQL, sleep quality and hospitalization rates in restrictive thoracic diseases (RTD) and COPD patients with CHRF.
METHODS


In this prospective, single center study patients divided into two groups; the COPD and the RTD groups. HRQL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality was assessed by Epworth and Pitsburg Sleep Quality Index (PSQI) questionnaires. The patients were re-evaluated one month, three months, sixth months, and one year following HNIV establishment, during which time, hospitalization rates were recorded.
RESULTS


Ninety (COPD n=50, RTD n=40) out of 102 eligible patients completed the study. Significant improvements in blood gases and HRQL were observed in the first month of HNIV establishment and remained stable. Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001). HNIV reduced hospitalization rates from a mean of 1.9±1.1 to 0.5±0.9 in COPD group (p<0.001) and a mean of 1.9±1 to 0.5±0.7 in RTD group (p<0.001).
CONCLUSION


HNIV improves HRQoL, sleep quality and gas exchange and reduces hospitalizations in patients with CHRF regardless of etiology.",2020,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"['patients with CHRF regardless of etiology', 'COPD n=50, RTD n=40) out of 102 eligible patients completed the study', 'restrictive thoracic diseases (RTD) and COPD patients with CHRF', 'patients with chronic hypercapnic respiratory failure (CHRF', 'Ninety', 'Patients with Chronic Respiratory Failure']","['Home Noninvasive Ventilation', 'Home noninvasive mechanical ventilation (HNIV', 'HNIV']","['blood gases and HRQL', 'Epworth and Pitsburg Sleep Quality Index (PSQI) questionnaires', 'Quality Of Life and Physiological Parameters', 'Mean±SD SRI summary scale', 'hospitalization rates', 'HRQL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality', 'HRQoL, sleep quality and gas exchange and reduces hospitalizations', 'HRQL, sleep quality and hospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960052', 'cui_str': 'Chronic hypercapnic respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0039978', 'cui_str': 'Disorder of thorax'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034088', 'cui_str': 'Pulmonic valve regurgitation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",102.0,0.0463646,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"[{'ForeName': 'Aycan', 'Initials': 'A', 'LastName': 'Yüksel', 'Affiliation': 'Ankara University, Faculty of Medicine, Department of Chest Diseases, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Çiftçi', 'Affiliation': 'Ankara University, Faculty of Medicine, Department of Chest Diseases, Ankara, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Çiledağ', 'Affiliation': 'Ankara University, Faculty of Medicine, Department of Chest Diseases, Ankara, Turkey.'}, {'ForeName': 'Akın', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Ankara University, Faculty of Medicine, Department of Chest Diseases, Ankara, Turkey.'}]",The clinical respiratory journal,['10.1111/crj.13221']
2488,32460451,Simplified instructional phrasing in dispatcher-assisted cardiopulmonary resuscitation - when 'less is more'.,"INTRODUCTION


In our national emergency dispatch centre, the standard protocol for dispatcher-assisted cardiopulmonary resuscitation (DACPR) in out-of-hospital cardiac arrests (OHCAs) involves the instruction ""push 100 times a minute 5 cm deep"". As part of quality improvement, the instruction was simplified to ""push hard and fast"".
METHODS


We analysed all dispatcher-diagnosed OHCAs over four months in 2018: January to February (""push 100 times a minute 5 cm deep"") and August to September (""push hard and fast""). We also performed secondary per-protocol analysis based on the protocol used: (a) standard (n = 48); (b) simplified (n = 227); and (c) own words (n = 231).
RESULTS


506 cases were included, 282 in the 'before' group and 224 in the 'after' group. Adherence to the protocol was 15.2% in the 'before' phase and 72.8% in the 'after' phase (p < 0.001). The mean time between instruction and first compression for the 'before' and 'after' groups was 34.36 seconds and 26.83 seconds, respectively (p < 0.001). Time to first compression was 238.62 seconds and 218.83 seconds in the 'before' and 'after' groups, respectively (p = 0.016). In the per-protocol analysis, the interval between instruction and compression was 37.19 seconds, 28.31 seconds and 32.40 seconds in the standard protocol, simplified protocol and 'own words' groups, respectively (p = 0.005). The need for paraphrasing was 60.4% in the standard protocol group and 81.5% in the simplified group (p < 0.001).
CONCLUSION


Simplified instructions were associated with a shorter interval between instruction and first compression. Efforts should be directed at simplifying DACPR instructions.",2020,"The mean time between instruction and first compression for the 'before' and 'after' groups was 34.36 seconds and 26.83 seconds, respectively (p < 0.001).","[""506 cases were included, 282 in the 'before' group and 224 in the 'after' group""]",['dispatcher-assisted cardiopulmonary resuscitation (DACPR'],"['mean time between instruction and first compression', 'Time to first compression']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",506.0,0.0351823,"The mean time between instruction and first compression for the 'before' and 'after' groups was 34.36 seconds and 26.83 seconds, respectively (p < 0.001).","[{'ForeName': 'Philip Weng Kee', 'Initials': 'PWK', 'LastName': 'Leong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Benjamin Sieu-Hon', 'Initials': 'BS', 'LastName': 'Leong', 'Affiliation': 'Emergency Medicine Department, National University Hospital, Singapore.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Arulanandam', 'Affiliation': 'Emergency Medical Services Department, Singapore Civil Defence Force, Singapore.'}, {'ForeName': 'Marie Xin Ru', 'Initials': 'MXR', 'LastName': 'Ng', 'Affiliation': 'Emergency Medical Services Department, Singapore Civil Defence Force, Singapore.'}, {'ForeName': 'Yih Yng', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Home Team Medical Services, Ministry of Home Affairs, Singapore.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Desmond Ren Hao', 'Initials': 'DRH', 'LastName': 'Mao', 'Affiliation': 'Department of Acute and Emergency Care, Khoo Teck Puat Hospital, Singapore.'}]",Singapore medical journal,['10.11622/smedj.2020080']
2489,32460459,Effectiveness of nivolumab versus regorafenib in hepatocellular carcinoma patients who failed sorafenib treatment.,"Background/Aims


Several treatment options are currently available for patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment. We aimed to compare the effectiveness of regorafenib and nivolumab in these patients.
Methods


Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included. Primary endpoint was overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events. Inverse probability of treatment weighting (IPTW) using the propensity score was conducted to reduce treatment selection bias.
Results


Among 150 study patients, 102 patients received regorafenib and 48 patients received nivolumab. Median OS was 6.9 (95% confidence interval [CI], 3.0-10.8) months for regorafenib and 5.9 (95% CI, 3.7-8.1) months for nivolumab (P=0.77 by log-rank test). In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04). Time to progression was not significantly different between groups (nivolumab vs. regorafenib: aHR, 0.82; 95% CI, 0.51-1.30; P=0.48). HRs were maintained after IPTW. Objective response rates were 5.9% and 16.7% in patients treated with regorafenib and nivolumab, respectively (P=0.04).
Conclusions


After sorafenib failure, the use of nivolumab may be associated with improved OS and better objective response rate as compared to using regorafenib.",2020,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","['150 study patients', 'Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included', 'patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment', '102 patients received', 'hepatocellular carcinoma patients who failed sorafenib treatment']","['nivolumab versus regorafenib', 'regorafenib', 'nivolumab', 'regorafenib and nivolumab']","['overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events', 'Median OS', 'Objective response rates', 'Time to progression', 'OS and better objective response rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",150.0,0.318331,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","[{'ForeName': 'Cheol-Hyung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minseok Albert', 'Initials': 'MA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0049n']
2490,32460460,Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response.,"Background/Aims


Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV.
Methods


This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded.
Results


Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events.
Conclusions


ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).",2020,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"['patients with LAM-resistant hepatitis B virus (HBV) infections', '91 patients whose', 'chronic hepatitis B patients with prior suboptimal response', 'Patients with baseline ADV resistance were excluded']","['lamivudine or telbivudine plus adefovir (LAM/LdT+ADV', 'Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir', 'LAM/LdT+ADV', 'entecavir plus tenofovir (ETV+TDF', 'ETV+TDF', 'new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV']","['rate of virologic response', 'high baseline HBV DNA level', 'rates of adverse events', 'virologic response', 'serum HBV DNA level', 'serum HBV DNA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C1453933', 'cui_str': 'telbivudine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]",91.0,0.051612,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"[{'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Jun Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Si Hyun', 'Initials': 'SH', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Tak', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Chonju, Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0044n']
2491,32460465,Effects of hypercarbia on arterial oxygenation during one-lung ventilation: prospective randomized crossover study.,"Background


The present study was designed to evaluate the effects of hypercarbia on arterial oxygenation during one-lung ventilation (OLV).
Methods


Fifty adult patients undergoing elective video-assisted thoracoscopic lobectomy or pneumonectomy were enrolled. Group 1 patients (n = 25) were first maintained in normocarbia (PaCO 2 : 38 - 42 mmHg) for 30 min and then in hypercarbia (45 - 50 mmHg). In group 2 patients (n = 25), PaCO 2  was maintained in the reverse order. Arterial oxygen partial pressure (PaO 2 ), respiratory variables, hemodynamic variables, and hemoglobin concentration were compared during normocarbia and hypercarbia. Arterial O 2  content and O 2  delivery were calculated.
Results


PaO 2  values during normocarbia and hypercarbia were 66.5 ± 10.6 mmHg and 79.7 ± 17.3 mmHg, respectively, (mean difference: 13.2 mmHg, 95% CI for difference of means: 17.0 to 9.3, P < 0.001). SaO 2  values during normocarbia and hypercarbia were 92.5 ± 4.8% and 94.3 ± 3.1% (P = 0.009), respectively. Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 mL/cmH 2 O, P < 0.001), arterial O 2  content (15.4 ± 1.4 vs. 14.9 ± 1.5 mL/dL, P < 0.001) and O 2  delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 mL/min, P <0.001) were significantly higher during hypercarbia than during normocarbia.
Conclusions


Hypercarbia increases PaO 2  and O 2  carrying capacity and improves pulmonary mechanics during OLV, suggesting that it may be helpful to manage oxygenation during OLV. Therefore, permissive hypercarbia may be a simple and valuable modality to manage arterial oxygenation during OLV.",2020,"Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 mL/cmH 2 O, P < 0.001), arterial O 2  content (15.4 ± 1.4 vs. 14.9 ± 1.5 mL/dL, P < 0.001) and O 2  delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 mL/min, P <0.001) were significantly higher during hypercarbia than during normocarbia.
","['one-lung ventilation', 'Fifty adult patients undergoing']","['hypercarbia', 'elective video-assisted thoracoscopic lobectomy or pneumonectomy']","['Static compliance of the lung', 'arterial oxygenation', 'Arterial oxygen partial pressure (PaO 2 ), respiratory variables, hemodynamic variables, and hemoglobin concentration', 'Arterial O 2  content and O 2  delivery']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0032284', 'cui_str': 'Pneumonectomy'}]","[{'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",25.0,0.0579572,"Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 mL/cmH 2 O, P < 0.001), arterial O 2  content (15.4 ± 1.4 vs. 14.9 ± 1.5 mL/dL, P < 0.001) and O 2  delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 mL/min, P <0.001) were significantly higher during hypercarbia than during normocarbia.
","[{'ForeName': 'Junho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Chonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Yesull', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Chonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Juhan', 'Initials': 'J', 'LastName': 'Mun', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Chonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Chonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Seonghoon', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Chonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19445']
2492,32460511,"Ultra-low-dose CT-guided lung biopsy in clinic: radiation dose, accuracy, image quality, and complication rate.","BACKGROUND


Computed tomography (CT)-guided percutaneous lung biopsy is usually performed by helical scanning. However, there are no studies on radiation dose, diagnostic accuracy, image quality, and complications based on axial scan mode.
PURPOSE


To determine radiation dose, accuracy, image quality, and complication rate following an ultra-low-dose (ULD) protocol for CT-guided lung biopsy in clinic.
MATERIAL AND METHODS


A total of 105 patients were enrolled to receive CT-guided lung biopsy. The use of an ULD protocol (axial scan) for CT-guided biopsy was initiated. Patients were randomly assigned to axial mode (Group A) and conventional helical mode (Group B) CT groups. 64-slice CT was performed for CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle. The radiation dose, accuracy, image quality, and complication rate were measured.
RESULTS


Ninety-seven patients were selected for the final phase of the study. There was no significant difference between the two groups for pulmonary nodule characteristics ( P  > 0.05). The mean effective dose in group A (0.077 ± 0.010 mSv) was significantly reduced relative to group B (0.653 ± 0.177 mSv,  P  < 0.001). There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
CONCLUSION


An ULD protocol for CT-guided lung nodule biopsy yields a reduction in the radiation dose without significant change in the accuracy, image quality, and complication rate relative to the conventional helical mode scan.",2020,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","['Ninety-seven patients were selected for the final phase of the study', '105 patients were enrolled to receive']","['Computed tomography (CT)-guided percutaneous lung biopsy', 'ultra-low-dose (ULD) protocol for CT-guided lung biopsy', 'CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle', 'CT-guided lung biopsy', 'ULD protocol (axial scan', 'Ultra-low-dose CT-guided lung biopsy', 'conventional helical mode (Group B']","['accuracy, image quality, and complication rate relative', 'pulmonary nodule characteristics', 'accuracy, image quality, and complication rate', 'radiation dose, accuracy, image quality, and complication rate']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0181960', 'cui_str': 'Biopsy needle'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",105.0,0.0266202,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185120917622']
2493,32460523,"A Randomized, Double-Blind, Placebo-Controlled Trial of Vilazodone in Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up.","Objective:  To evaluate the efficacy and long-term safety of vilazodone in children and adolescent outpatients with major depressive disorder (MDD).  Methods:  Children and adolescents aged 7-17 years of age with MDD were randomized 2:2:1 to 8 weeks of double-blind placebo, vilazodone 15 or 30 mg/day or fluoxetine 20 mg/day, respectively. The primary and secondary efficacy outcomes, respectively, were change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score analyzed using a mixed model for repeated measurement approach. Patients who completed the 8-week randomized controlled trial (RCT), as well as new ( de novo ) patients, could participate in a 26-week, vilazodone-only, open-label extension (OLE) study.  Results:  The RCT enrolled 473 patients (60% female) with an average age of 13 years. Change in CDRS-R and CGI-S scores from baseline to week 8 did not differ between patients who received vilazodone and those randomized to placebo. The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3,  p  = 0.77; least-squares mean difference [LSMD] = -0.40). For fluoxetine, the LSMD versus placebo was -2.3 ( p  = 0.14). The OLE enrolled 330 patients (60% female) with an average age of 13-14 years. Overall, no new safety concerns were identified compared to what is known in adults.  Conclusions:  Similar improvements in depressive symptoms were observed in all arms. This study does not support the efficacy of vilazodone 15 or 30 mg/day for pediatric patients with MDD. No new or unexpected safety concerns were detected during the RCT or OLE studies.",2020,"The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3,  p  = 0.77; least-squares mean difference [LSMD] = -0.40).","['pediatric patients with MDD', 'enrolled 330 patients (60% female) with an average age of 13-14 years', 'Children and adolescents aged 7-17 years of age with MDD', 'enrolled 473 patients (60% female) with an average age of 13 years', 'Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up', 'children and adolescent outpatients with major depressive disorder (MDD']","['Vilazodone', 'Placebo', 'OLE', 'RCT', 'placebo', 'fluoxetine', 'placebo, vilazodone 15 or 30\u2009mg/day or fluoxetine', 'vilazodone-only, open-label extension (OLE) study', 'vilazodone']","['Change in CDRS-R and CGI-S scores', ""Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score"", 'CDRS-R scores', 'depressive symptoms']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1530072', 'cui_str': 'vilazodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",473.0,0.134338,"The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3,  p  = 0.77; least-squares mean difference [LSMD] = -0.40).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'McCusker', 'Affiliation': 'CNS, AbbVie, Irvine, California, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Anxiety Disorders Research Program, University of Cincinnati, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0176']
2494,32460565,Use of calendula ointment after episiotomy: a randomized clinical trial.,"Objective:  Episiotomy is associated with an increased risk of postpartum pain, bleeding, and dyspareunia. The hypothesis of this trial was that in women with singleton pregnancy, and spontaneous labor at term, use of calendula ointment would reduce pain after episiotomy. Methods:  This was a single-center parallel group randomized trial of women with singleton pregnancies and spontaneous labor at term who were randomized to either use of calendula ointment (i.e. intervention group) or standard care (i.e. control group) after episiotomy. Eligible women were those with singleton gestations in spontaneous labor and vertex presentation at term. Women with premature rupture of membranes were excluded from the study. Women in the intervention group were recommended use of calendula ointment 4 h after the episiotomy and then every 8 h for 10 days. The primary outcome was the pain level. Pain level was self-reported and recorded using the verbal rating scale (VRS). The effect of the calendula ointment was quantified as mean difference (MD) with 95% confidence interval (CI). Results:  During the study, 100 women agreed to take part in the study, underwent randomization, and were enrolled in this trial. Of the 100 randomized women, 50 were randomized to the calendula ointment group, and 50 to the control group. No women were excluded after randomization or lost to follow up.Women who received calendula ointment after episiotomy compared to standard care had a significantly lower pain level starting from day two and during all the follow-up. Calendula ointment also improve wound healing in terms of redness and edema. Conclusions:  Use of calendula ointment significantly reduce pain after episiotomy.",2020,Women who received calendula ointment after episiotomy compared to standard care had a significantly lower pain level starting from day two and during all the follow-up.,"['Eligible women were those with singleton gestations in spontaneous labor and vertex presentation at term', '100 randomized women, 50', '100 women agreed to take part in the study, underwent randomization, and were enrolled in this trial', 'after episiotomy', 'women with singleton pregnancy, and spontaneous labor at term', 'Women with premature rupture of membranes', 'women with singleton pregnancies and spontaneous labor at term']","['calendula ointment', 'calendula ointment (i.e. intervention group) or standard care (i.e. control group) after episiotomy']","['pain level', 'verbal rating scale (VRS', 'risk of postpartum pain, bleeding, and dyspareunia', 'wound healing', 'pain', 'Pain level']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0233260', 'cui_str': 'Vertex presentation'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}]","[{'cui': 'C0752223', 'cui_str': 'Marigold'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.132741,Women who received calendula ointment after episiotomy compared to standard care had a significantly lower pain level starting from day two and during all the follow-up.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'De Angelis', 'Affiliation': 'Casa di Cura Accreditata Fabia Mater, Rome, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Casa di Cura Accreditata Fabia Mater, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Vitale', 'Affiliation': 'Casa di Cura Accreditata Fabia Mater, Rome, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maria Chiara De', 'Initials': 'MC', 'LastName': 'Angelis', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Brunella', 'Initials': 'B', 'LastName': 'Zizolfi', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1770219']
2495,32460575,Working Memory and Response Inhibition Effects on At-Risk Youth's Willingness to Use Multiple Nicotine and Tobacco Products.,"Purpose:  Past research has suggested that executive functions, such as working memory and response inhibition, predict the use of nicotine and tobacco products (NTPs). The current study extends prior research by assessing whether response inhibition and working memory are associated with at-risk youth's willingness to use NTPs.  Methods:  A sample of 1060 at-risk youth were recruited from alternative high schools in southern California. Participants were randomly assigned to complete the Symmetry Span Task, an indicator of working memory ability, or the cued Go/No-Go task, an indicator of response inhibition. Participants who reported never using NTPs ( n  = 348) indicated how willing they would be try NTPs.  Results:  Results from a cross-sectional zero-inflated negative binomial (ZINB) regression suggest that females with stronger working memory skills and individuals with weaker response inhibition skills were more likely to be unwilling to use NTPs.  Conclusion:  While further research is needed to determine whether executive functions can prospectively predict NTP use among at-risk youth, the current study indicates that both working memory and response inhibition may play a significant role.",2020,"Participants were randomly assigned to complete the Symmetry Span Task, an indicator of working memory ability, or the cued Go/","['Participants who reported never using NTPs ( n \u2009=\u2009348', 'sample of 1060 at-risk youth were recruited from alternative high schools in southern California']","['Symmetry Span Task, an indicator of working memory ability, or the cued Go']",['cross-sectional zero-inflated negative binomial (ZINB) regression'],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",,0.0298494,"Participants were randomly assigned to complete the Symmetry Span Task, an indicator of working memory ability, or the cued Go/","[{'ForeName': 'Maya A', 'Initials': 'MA', 'LastName': 'Pilin', 'Affiliation': 'Psychology Department, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Pike', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, Claremont, California, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, Claremont, California, USA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Stacy', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, Claremont, California, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1771595']
2496,32460583,Acceptability of telehealth-delivered rehabilitation: Experiences and perspectives of people with traumatic brain injury and their carers.,"INTRODUCTION


Communication skills training for people with traumatic brain injury (TBI) and their carers is recommended best practice. Delivery via telehealth could improve access to this training. This paper focuses on the acceptability of telehealth delivery of communication skills training.
METHODS


A mixed-methods investigation of acceptability of telehealth to people with TBI and their carers was incorporated into a clinical trial. Thirty-six people with TBI (23 metropolitan and 13 regional) and their carers were recruited. Metropolitan participants were randomly allocated to telehealth or in-person intervention at a 1:3 ratio. Regional participants were allocated to telehealth. Telehealth and in-person participants were compared on retention, time to complete the programme, home practice completion and therapeutic alliance ratings. Participants completed semi-structured interviews regarding their views on telehealth, which were analysed using thematic analysis.
RESULTS


There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings. Three themes were identified: 'telehealth delivery opens a window for access to rehabilitation in the context of my daily life', 'in-person delivery offers rehabilitation based on natural human interaction' and 'weighing telehealth against in-person delivery'.
DISCUSSION


Participants found telehealth delivery acceptable, as indicated by the similarity between groups in the quantitative process measures, and as reported in interviews. Some reported a preference for in-person delivery if there had been a choice of delivery mode. Participants described characteristics of the two delivery modes which were relevant to their attitudes towards telehealth.",2020,"There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings.","['Metropolitan participants', 'Thirty-six people with TBI (23 metropolitan and 13 regional) and their carers were recruited', 'people with traumatic brain injury (TBI) and their carers', 'people with traumatic brain injury and their carers', 'people with TBI and their carers']","[""telehealth delivery opens a window for access to rehabilitation in the context of my daily life', 'in-person delivery offers rehabilitation based on natural human interaction' and 'weighing telehealth against in-person delivery"", 'Communication skills training', 'telehealth or in-person intervention', 'telehealth-delivered rehabilitation']","['retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521124', 'cui_str': 'Against'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}]",36.0,0.0622804,"There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings.","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'The University of Technology Sydney, Graduate School of Health, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20923824']
2497,32460584,Holistic Nursing in Practice: Mindfulness-Based Yoga as an Intervention to Manage Stress and Burnout.,"PURPOSE


Effects of a mindfulness-based (MB) yoga practice on stress, burnout, and indicators of well-being among nurses and health care professionals (HCPs).
DESIGN


A randomized controlled trial, 80 HCPs assigned to either MB yoga intervention or control group.
METHOD


The MB yoga intervention group ( n  = 41) attended weekly yoga classes and practiced yoga independently. The control group ( n  = 39) did not receive the yoga intervention. Study participants completed pre- and postintervention questionnaires, instruments included (a) Perceived Stress Scale; (b) Maslach Burnout Inventory; (c) Vitality subscale of the Medical Outcomes Study Short Form-36; (d) Global Sleep Quality item, (e) Mindfulness Awareness Survey, and (f) subscale of the Brief Serenity Scale. Diurnal salivary cortisol and blood pressure were assessed pre and postintervention.
RESULTS


Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey). Diurnal cortisol slopes and blood pressure were not significantly improved.
CONCLUSION


The MB yoga intervention had a statistically significant effect on the health and well-being of nurses and HCPs, most specifically for measures of stress; perceived stress, burnout, vitality, sleep quality, serenity, and mindfulness.",2020,"RESULTS


Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey).",[],"['yoga intervention', 'MB yoga intervention or control group', 'mindfulness-based (MB) yoga practice', 'MB yoga intervention', 'MB yoga intervention group ( n \u2009=\u200941) attended weekly yoga classes and practiced yoga independently']","['pre- and postintervention questionnaires, instruments included (a) Perceived Stress Scale; (b) Maslach Burnout Inventory; (c) Vitality subscale of the Medical Outcomes Study Short Form-36; (d) Global Sleep Quality item, (e) Mindfulness Awareness Survey, and (f) subscale of the Brief Serenity Scale', 'health and well-being of nurses and HCPs, most specifically for measures of stress; perceived stress, burnout, vitality, sleep quality, serenity, and mindfulness', 'MB yoga', 'Diurnal cortisol slopes and blood pressure', 'Diurnal salivary cortisol and blood pressure', 'stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey']",[],"[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",80.0,0.0182787,"RESULTS


Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hilcove', 'Affiliation': 'HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Marceau', 'Affiliation': 'HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Thekdi', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Brewer', 'Affiliation': 'HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Rhodes University; Stellenbosch University.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010120921587']
2498,32460589,"Effect of  Gymnema sylvestre  Administration on Glycemic Control, Insulin Secretion, and Insulin Sensitivity in Patients with Impaired Glucose Tolerance.","Gymnema sylvestre , a plant typical of India, has long been known for its hypoglycemic effects. The objective of this study was to evaluate the effect of  G. sylvestr e administration on glycemic control, insulin secretion, and insulin sensitivity in patients with impaired glucose tolerance (IGT). A randomized, double-blind, placebo-controlled clinical trial was conducted in 30 patients with IGT. Fifteen patients randomly received  G. sylvestre  in doses of 300 mg b.i.d. and the other 15 received placebo in the same way. Before and after the intervention, anthropometric and metabolic measurements were taken, including 2-h oral glucose tolerance test (2-h OGTT), fasting plasma glucose, glycated hemoglobin A1c (A1C), and the lipid profile panel. Areas under the curve of glucose and insulin were calculated, as well as the insulinogenic, Stumvoll, and Matsuda indices. Wilcoxon, Mann-Whitney U, and chi-square or Fisher's exact tests were performed, and a  P -value ≤.05 was considered statistically significant. There was a significant reduction in 2-h OGTT (9.1 ± 1.2 vs. 7.8 ± 1.7 mmol/L,  P  = .003), A1C (5.8 ± 0.3% vs. 5.4 ± 0.4%,  P  = .025), body weight, body mass index, and low-density lipoprotein cholesterol levels in the  G. sylvestre  group, with an increment in the Matsuda index (1.8 ± 0.8 vs. 2.4 ± 1.2,  P  = .008). At the end of the intervention, 46.7% of the patients obtained normal values in A1C. In conclusion,  G. sylvestre  administration in patients with IGT decreased 2-h OGTT and A1C, increasing insulin sensitivity. There were also improvements in anthropometric measures and the lipid profile.",2020,"There was a significant reduction in 2-h OGTT (9.1 ± 1.2 vs. 7.8 ± 1.7 mmol/L,  P  = .003), A1C (5.8 ± 0.3% vs. 5.4 ± 0.4%,  P  = .025), body weight, body mass index, and low-density lipoprotein cholesterol levels in the  G. sylvestre  group, with an increment in the Matsuda index (1.8 ± 0.8 vs. 2.4 ± 1.2,  P  = .008).","['30 patients with IGT', 'Patients with Impaired Glucose Tolerance', 'patients with impaired glucose tolerance (IGT', 'Fifteen patients randomly received']","['placebo', 'G. sylvestr e administration', 'G. sylvestre  in doses of 300\u2009mg b.i.d', 'Gymnema sylvestre  Administration']","['Glycemic Control, Insulin Secretion, and Insulin Sensitivity', ""Wilcoxon, Mann-Whitney U, and chi-square or Fisher's exact tests"", 'anthropometric measures and the lipid profile', 'glycemic control, insulin secretion, and insulin sensitivity', 'body weight, body mass index, and low-density lipoprotein cholesterol levels', '2-h OGTT and A1C, increasing insulin sensitivity', '2-h oral glucose tolerance test (2-h OGTT), fasting plasma glucose, glycated hemoglobin A1c (A1C), and the lipid profile panel']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0937629', 'cui_str': 'Gymnema Sylvestre Preparation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",30.0,0.0531057,"There was a significant reduction in 2-h OGTT (9.1 ± 1.2 vs. 7.8 ± 1.7 mmol/L,  P  = .003), A1C (5.8 ± 0.3% vs. 5.4 ± 0.4%,  P  = .025), body weight, body mass index, and low-density lipoprotein cholesterol levels in the  G. sylvestre  group, with an increment in the Matsuda index (1.8 ± 0.8 vs. 2.4 ± 1.2,  P  = .008).","[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Gaytán Martínez', 'Affiliation': 'Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Sánchez-Ruiz', 'Affiliation': 'Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Laura Y', 'Initials': 'LY', 'LastName': 'Zuñiga', 'Affiliation': 'Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González-Ortiz', 'Affiliation': 'Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': 'Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2020.0024']
2499,32460639,The effect of targeted resistance training on bench press performance and the alternation of prime mover muscle activation patterns.,"Targeted muscle strengthening might improve performance or help overcome training stagnation; therefore, the aim of the present study was to investigate changes in muscle activity patterns before and after six weeks of targeted resistance training. Twenty-seven resistance-trained men were divided into three groups according to their prime mover activity, as measured by surface electromyography during a bench press (BP). Each group underwent a six-week block of targeted exercises for one of the following muscles: anterior deltoid (AD), pectoralis major (PM) or triceps brachii (TB). ANOVA showed that each group increased their 1 repetition maximum (1RM) (p < 0.05) and the activity of the exercised muscle group during an isometric bench press (p < 0.01) and during a dynamic bench press (p < 0.01) at 85% of the 1RM. During the isometric BP, the TB training group had an increase in TB activity in comparison to the other groups. Targeted muscle training is a useful method for muscle activity increase and increasing the maximum strength in complex exercise, when applied in activity-deficient muscle groups. Strengthening the TB elicits changes in all prime movers and results in TB activity domination during a bench press.",2020,ANOVA showed that each group increased their 1 repetition maximum (1RM) (p < 0.05) and the activity of the exercised muscle group during an isometric bench press (p < 0.01) and during a dynamic bench press (p < 0.01) at 85% of the 1RM.,['Twenty-seven resistance-trained men'],"['targeted resistance training', 'six-week block of targeted exercises for one of the following muscles: anterior deltoid (AD), pectoralis major (PM) or triceps brachii (TB']","['muscle activity patterns', 'TB activity domination', 'TB activity', '1 repetition maximum (1RM']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0162427,ANOVA showed that each group increased their 1 repetition maximum (1RM) (p < 0.05) and the activity of the exercised muscle group during an isometric bench press (p < 0.01) and during a dynamic bench press (p < 0.01) at 85% of the 1RM.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Stronska', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice , Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice , Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice , Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice , Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice , Katowice, Poland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': 'Department of Sport Games, Faculty of Physical Education and Sport, Charles University , Prague, Czech Republic.'}]",Sports biomechanics,['10.1080/14763141.2020.1752790']
2500,32460658,Situational Victimization Cues Strengthen Implicit and Explicit Self-Victim Associations: An Experiment With College-Aged Adults.,"Contextually salient social identities are those that individuals may not think of often but that may be temporarily activated by relevant situational cues. We hypothesized that victim, one of many identities people may possess, is a contextually salient identity that operates both implicitly and explicitly. To test this hypothesis, the present research tests the effect of a situational victimization cue on implicit and explicit self-victim associations. We utilized an experiment with a 2 (Victimization salience: yes vs. no) × 2 (Past victimization experience: yes vs. no) between-participants design. One hundred eighty-one undergraduate student participants were recruited and randomized into one of two conditions: (a) an experimental condition reminding them of a previous victimization experience or (b) a control condition whereby they did not receive a reminder. All participants then completed one Single-Category Implicit Association Test, and self-report measures of explicit self-victim associations and victimization experience. Between-participants analyses of variance were used to analyze data. Results indicated that individuals who were reminded of a previous victimization exhibited stronger explicit and implicit self-victim associations compared to those who were not reminded. This research provides initial evidence that victim is a contextually salient identity, which has implications for the factors and processes underlying identity formation, revictimization, and the prevention of repeat victimization.",2020,Results indicated that individuals who were reminded of a previous victimization exhibited stronger explicit and implicit self-victim associations compared to those who were not reminded.,"['College-Aged Adults', 'One hundred eighty-one undergraduate student participants']","['situational victimization cue', 'experimental condition reminding them of a previous victimization experience or (b) a control condition whereby they did not receive a reminder']",['Situational Victimization Cues Strengthen Implicit and Explicit Self-Victim Associations'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",181.0,0.0171426,Results indicated that individuals who were reminded of a previous victimization exhibited stronger explicit and implicit self-victim associations compared to those who were not reminded.,"[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Sachs', 'Affiliation': 'Fairleigh Dickinson University, Teaneck, NJ, USA.'}, {'ForeName': 'Bonita M', 'Initials': 'BM', 'LastName': 'Veysey', 'Affiliation': 'Rutgers University, Newark, NJ, USA.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Rivera', 'Affiliation': 'Rutgers University, Newark, NJ, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520922368']
2501,32460679,Fruit supplementation reduces indices of exercise-induced muscle damage: a systematic review and meta-analysis.,"This systematic review and meta-analysis examined the effects of fruit supplements on indices of muscle damage and physical performance measures following muscle-damaging exercise protocols. The PEDro scale and Cochrane's risk of bias tool was used to critically appraise each study, whilst forest plots were generated to report on standardised mean differences (SMD) and p-values. The studies employed a crossover-randomised design, or a randomised controlled placebo design, with measures compared between the supplement (SUPP) and placebo (PLA) conditions at 24 and 48 hours following the muscle-damaging exercise protocols. Compared to the PLA condition, the SUPP condition exhibited significantly lower levels of indirect muscle damage markers (p = 0.02; I 2  = 44%), inflammatory markers (p = 0.03; I 2  = 45%) and oxidative stress (p < 0.001; I 2  = 58%), whilst antioxidant capacity was significantly increased (p = 0.04; I 2  = 82%) at 24 hours post-exercise. The maximal isometric voluntary contraction was significantly greater for the SUPP condition than the PLA at 24 hours (p < 0.001; I 2  = 81%) and 48 hours (p < 0.001; 84%) post-exercise. Only a few studies reported on functional outcome measures (i.e., countermovement jump, cycling, sprint and running maximal oxygen uptake), and the findings appeared conflicting according to qualitative analyses. Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD. These findings demonstrate that fruit supplements could be used as recovery strategies from strenuous exercise sessions.",2020,"Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD.",[],"['supplement (SUPP) and placebo (PLA', 'Fruit supplementation', 'fruit supplements', 'placebo']","['maximal isometric voluntary contraction', 'levels of indirect muscle damage markers', 'oxidative stress', 'muscle damage and physical performance measures', 'antioxidant capacity', 'functional outcome measures (i.e., countermovement jump, cycling, sprint and running maximal oxygen uptake', 'inflammatory markers', 'level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility']",[],"[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",,0.0693269,"Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Connor', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}]",European journal of sport science,['10.1080/17461391.2020.1775895']
2502,32460697,"The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study.","BACKGROUND


Elevated Staphylococcus aureus and oral bacterial concentrations are known to correlate with pneumonia hospitalization in nursing home residents. However, the effects of a professional oral care intervention on these factors remain unclear. The aims of this quasi-experimental study were to compare bacterial concentrations in saliva and sputum, oral health status, distribution of Staphylococcus aureus, and pneumonia status before and after a professional oral care intervention.
METHODS


A purposive sample of residents from two nursing homes was divided into an intervention group that received a weekly professional oral care intervention and a control group. Oral bacterial concentration was determined by real-time polymerase chain reaction. The Staphylococcus aureus distribution was determined by bacterial culture and matrix-assisted laser desorption/ionization-time of flight mass spectrometry. After data collection, a statistical analysis was performed to evaluate the effect of the intervention.
RESULTS


Most residents were unconscious (80%), and most had a history of pneumonia (76%). Baseline demographic data did not significantly differ between the two groups. After the intervention, the intervention group had significant improvements in plaque index (1.66 ± 0.78 vs. 0.94 ± 0.64, p <  0.01), gingival index (2.36 ± 0.76 vs. 1.65 ± 0.83, p <  0.01), tongue coating index (0.96 ± 1.10 vs. 0.16 ± 0.47, p <  0.01), distribution of Staphylococcus aureus in salivary samples (11.11 ± 14.47% vs. 1.74 ± 3.75%, p = 0.02), and salivary bacterial concentration ([4.27 ± 3.65] × 10 5  vs. [0.75 ± 1.20] × 10 5 , p <  0.01). Sputum bacterial concentration did not significantly differ. The intervention group also had a significantly lower annual prevalence of pneumonia hospitalization (1.24 ± 1.51 vs. 0.48 ± 0.59, p = 0.01), especially in residents whose salivary bacterial concentration exceeded the median. However, the duration of pneumonia hospitalization did not significantly differ between the two groups.
CONCLUSION


A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization.
TRIAL REGISTRATION


Trial registration: ClinicalTrials.gov, NCT03874962. Registered 12 March 2019 - Retrospectively registered.",2020,"A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization.
","['nursing home residents', 'A purposive sample of residents from two nursing homes', 'Taiwan nursing home residents']","['professional oral care intervention', 'professional oral care intervention and a control group', 'oral care intervention']","['distribution of Staphylococcus aureus in salivary samples', 'Sputum bacterial concentration', 'annual prevalence of pneumonia hospitalization', 'salivary bacterial concentration', 'bacterial concentrations in saliva and sputum, oral health status, distribution of Staphylococcus aureus, and pneumonia status', 'pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration', 'oral health, reduce levels of salivary bacteria and Staphylococcus aureus', 'tongue coating index', 'Oral bacterial concentration', 'history of pneumonia', 'duration of pneumonia hospitalization', 'gingival index', 'Baseline demographic data', 'plaque index']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455542', 'cui_str': 'H/O: pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",,0.0851238,"A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization.
","[{'ForeName': 'Tien-Cheng', 'Initials': 'TC', 'LastName': 'Chiang', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, No.100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan.'}, {'ForeName': 'Ming-Shyan', 'Initials': 'MS', 'LastName': 'Huang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, E-DA Cancer Hospital, No. 21, Yida Rd., Yanchao Dist., Kaohsiung City, 824, Taiwan.'}, {'ForeName': 'Po-Liang', 'Initials': 'PL', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Medical University Hospital, No.100, Tzyou 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan.'}, {'ForeName': 'Shun-Te', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Division of Special Care Dentistry, Department of Dentistry, Kaohsiung Medical University Hospital, No.100, Tzyou 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan. shuntehuang@gmail.com.'}, {'ForeName': 'Ying-Chu', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, No.100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan. chulin@kmu.edu.tw.'}]",BMC infectious diseases,['10.1186/s12879-020-05061-z']
2503,32460699,"Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.","BACKGROUND


Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an α 2 -adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs.
METHODS


This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A total of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.4 μg/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 μg/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7 days after surgery.
RESULTS


The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7 days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P = 0.017). In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516). When the total dose of DEX was more than 328 μg, the patients were unlikely to have PPCs (ROC curve, AUC = 0.614, P = 0.009).
CONCLUSIONS


For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7 days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.",2020,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","['160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'number', 'patients after oral and maxillofacial surgery with fibular free flap reconstruction']","['DEX or placebo (normal saline', 'DEX', 'Dexmedetomidine', 'Dexmedetomidine (DEX', 'maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'placebo']","['postoperative pulmonary complications', 'incidence of PPCs according to Clavien-Dindo score', 'length of hospital stay', 'occurrence of PPCs', 'prevalence of bradycardia or hypotension', 'incidence of PPCs', 'postoperative survival probability']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",160.0,0.736349,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China. 3917798@qq.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China. kqyangxudong@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01045-3']
2504,32460712,Efficacy of a single dose versus a multiple dose regimen of Mebendazole against hookworm infections among school children: a randomized open-label trial.,"BACKGROUND


Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500 mg) versus multiple doses (100 mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children.
METHODS


This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant.
RESULT


One hundred eight children, 54 in each treatment arm had completed baseline data and received allocated treatment. One hundred three children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.
CONCLUSION


The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple doses revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas.
TRIAL REGISTRATION


This trial is retrospectively registered in www.pactr.org, number PACTR201911466695052 on November 26, 2019.",2020,Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001.,"['eligible hookworm-positive children', 'school-aged children', 'One hundred eight children, 54 in each treatment arm had completed baseline data and received allocated treatment', 'school children', 'school-aged children (6-14\u2009years old) in Burie and Debre Elias towns, Northwest Ethiopia', 'One hundred three children had completed follow-up data records and included for the final efficacy analysis']","['Mebendazole', 'albendazole or mebendazole', 'mebendazole']","['poor cure and egg reduction rates', 'cure and egg reduction rates', 'Cure rate against hookworm', 'egg reduction rate']","[{'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0025023', 'cui_str': 'Mebendazole'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}]",108.0,0.16424,Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001.,"[{'ForeName': 'Tegegne', 'Initials': 'T', 'LastName': 'Eshetu', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia. tegegneeshetu5@gmail.com.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Aemero', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia.'}, {'ForeName': 'Ayalew Jejaw', 'Initials': 'AJ', 'LastName': 'Zeleke', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia.'}]",BMC infectious diseases,['10.1186/s12879-020-05097-1']
2505,32460725,"A two arm randomized controlled trial comparing the short and long term effects of an elimination diet and a healthy diet in children with ADHD (TRACE study). Rationale, study design and methods.","BACKGROUND


Food may trigger Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. Therefore, an elimination diet (ED) might be an effective treatment for children with ADHD. However, earlier studies were criticized for the nature of the control group, potential confounders explaining the observed effects, unsatisfactory blinding, potential risks of nutritional deficiencies and unknown long term and cost-effectiveness. To address these issues, this paper describes the rationale, study design and methods of an ongoing two arm randomized controlled trial (RCT) comparing the short (5 week) and long term (1 year) effects of an elimination diet and a healthy diet compared with care as usual (CAU) in children with ADHD.
METHODS


A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet. A comparator arm including N = 60 children being solely treated with CAU (e.g. medication) is used to compare the effects found in both dietary groups. The two armed RCT is performed in two youth psychiatry centers in the Netherlands, with randomization within each participating center. The primary outcome measure is response to treatment defined as a ≥ 30% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile). This is assessed after 5 weeks of dietary treatment, after which participants continue the diet or not. Secondary outcome measures include the Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness. Assessments take place at the start of the study (T0), after five weeks (T1), four months (T2), eight months (T3) and 12 months of treatment (T4). T0, T1 and T4 assessments take place at one of the psychiatric centers. T2 and T3 assessments consist of filling out online questionnaires by the parents only.
DISCUSSION


This RCT will likely contribute significantly to clinical practice for ADHD by offering insight into the feasibility, nutritional quality, (cost-)effectiveness and long term effects of dietary treatments for ADHD.
TRIAL REGISTRATION


www.trialregister.nl, NTR5434. Registered at October 11th, 2015.",2020,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"['children with ADHD', 'children with ADHD (TRACE study', 'two youth psychiatry centers in the Netherlands, with randomization within each participating center', 'A total of N\u2009=\u2009162 children (5-12\u2009years) with ADHD']","['elimination diet and a healthy diet', 'elimination diet and a healthy diet compared with care as usual (CAU', 'CAU (e.g. medication']","['response to treatment defined as a\u2009≥\u200930% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile', 'Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0521246,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"[{'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands. a.bosch@karakter.com.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Bierens', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Ardine G', 'Initials': 'AG', 'LastName': 'de Wit', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Leiden University, Institute of Psychology and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'van der Velde', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'de Boer', 'Affiliation': 'Accare, Child and Adolescent Psychiatry, Groningen, the Netherlands.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'van Beek', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Appelman', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Visser', 'Affiliation': 'Freelance dietician, Velp, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bos', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'van der Meer', 'Affiliation': 'De Bascule, Center for Child and Adolescent Psychiatry, Amsterdam, The Netherlands.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Kamphuis', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jos M T', 'Initials': 'JMT', 'LastName': 'Draaisma', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's hospital, Nijmegen, the Netherlands.""}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bottelier', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arias-Vasquez', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Klip', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Saskia W', 'Initials': 'SW', 'LastName': 'van den Berg', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Nanda N', 'Initials': 'NN', 'LastName': 'Rommelse', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02576-2']
2506,32460748,The safe use of dating applications among men who have sex with men: a study protocol for a randomised controlled trial to evaluate an interactive web-based intervention to reduce risky sexual behaviours.,"BACKGROUND


Notably, both international and local studies have found a high prevalence of sexually transmitted infections (STIs) and risky sexual behaviours, such as condomless anal sex, substance misuse in conjunction with sex ('chemsex') and group sex, among men who have sex with men (MSM) dating application (app) users. Although the use of dating apps is an emerging sexual risk factor, little effort has been expended on the promotion of safe sex and good sexual health among the users of those apps. Therefore, the aim of the proposed study is to develop and evaluate the effectiveness of an interactive web-based intervention in improving the sexual health of MSM dating app users in Hong Kong.
METHODS


A two-armed randomised controlled trial will be conducted. Chinese MSM dating app users will be recruited and randomly allocated into either the intervention (n = 200) or control group (n = 200). Subjects in the intervention group will receive the web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing. The control group will receive only web-based information without sexual health components. Subjects in both groups will be evaluated at baseline and three and 6 months after baseline. The primary outcome will be the frequency of condomless anal sex in the past 3 months.
DISCUSSION


The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users. The web-based intervention, if found successful, will have important clinical and policy implications, as it can be adopted by the government and non-governmental organisations targeting MSM. Moreover, the proposed intervention can reach many MSM at relatively low cost, and thus has the potential to check the burgeoning HIV/STI epidemic among MSM in Hong Kong in a cost-effective manner.
TRIAL REGISTRATION


International standard randomized controlled trial number (ISRCTN) registry: ISRCTN16681863 registered on 28 April 2020.",2020,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"['men who have sex with men (MSM) dating application (app) users', 'MSM dating app users in Hong Kong', 'Chinese MSM dating app users', 'men who have sex with men']","['web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing', 'control group will receive only web-based information without sexual health components', 'interactive web-based intervention']","['risky sexual behaviours', 'frequency of condomless anal sex in the past 3\u2009months']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0901602,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"[{'ForeName': 'Edmond P H', 'Initials': 'EPH', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong. h0714919@connect.hku.hk.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Janet Y H', 'Initials': 'JYH', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Daniel Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}]",BMC public health,['10.1186/s12889-020-08914-z']
2507,32460752,The efficacy of a mobile phone application to improve adherence to treatment and self-management in people with chronic respiratory disease in Romanian population - a pilot study.,"BACKGROUND


Many studies assessed the effect of mobile phone applications on self-management outcomes in patients with asthma, but all of them presented variable results. In this paper. we examined the effect of a mobile phone application on self-management and disease control in Romanian population.
METHODS


This study included 93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment. Patients were divided into two groups. The first group included patients that received treatment, and the second group received treatment and also used the smartphone application. Number of exacerbations and asthma control test (ACT) were recorded.
RESULTS


The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001). Also, we found significant differences between the ACT score with-in each group, observing a significant improvement of the score between evaluations and baseline (related-samples Friedman's test with Bonferroni correction, p <  0.001). When considering the exacerbations rate, significantly less patients using the application presented exacerbations, 10.30% vs. 46.30% (Pearson Chi-square test, X 2  (1) = 13.707, p <  0.001).
CONCLUSION


Our study indicates that smartphone applications are an effective way to improve asthma control and self-management when used continually in our population. We found significant positive effects in disease control and exacerbation frequency.",2020,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","['93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment', 'patients with asthma', 'Romanian population', 'people with chronic respiratory disease in Romanian population ']","['mobile phone applications', 'smartphone application', 'mobile phone application']","['Number of exacerbations and asthma control test (ACT', 'exacerbations rate', 'ACT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",93.0,0.0376453,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","[{'ForeName': 'Laura Adela', 'Initials': 'LA', 'LastName': 'Munteanu', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Frandes', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania. mirela.frandes@umft.ro.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Timar', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Tudorache', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Ariadna Petronela', 'Initials': 'AP', 'LastName': 'Fildan', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Oancea', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Doina Ecaterina', 'Initials': 'DE', 'LastName': 'Tofolean', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}]",BMC health services research,['10.1186/s12913-020-05340-0']
2508,32460773,Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.,"BACKGROUND


Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial.
METHODS


Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods.
DISCUSSION


The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.",2020,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","['patients with chronic upper limb spasticity following stroke', '139 participants from 6 stroke units across 3 Australian states are participating in the trial']",[],"['cost utility analysis', 'incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained', 'incremental Quality Adjusted Life Year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",139.0,0.148825,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Milte', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia. rachel.milte@flinders.edu.au.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'Discipline of Physiotherapy, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Department of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia.'}]",BMC health services research,['10.1186/s12913-020-05333-z']
2509,32460786,"Protocol for a matched-pair cluster control trial of ARCHES (Addressing Reproductive Coercion in Health Settings) among women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya.","BACKGROUND


Reproductive coercion (RC) and intimate partner violence (IPV) are prevalent forms of gender-based violence (GBV) associated with reduced female control over contraceptive use and subsequent unintended pregnancy. Although the World Health Organization has recommended the identification and support of GBV survivors within health services, few clinic-based models have been shown to reduce IPV or RC, particularly in low or middle-income countries (LMICs). To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
INTERVENTION


ARCHES (Addressing Reproductive Coercion in Health Settings) is a single-session, clinic-based model delivered within routine contraceptive counseling that has been demonstrated to reduce RC in the United States. ARCHES was adapted to the Kenyan context via a participatory process to reduce GBV and unintended pregnancy among women and girls seeking contraceptive services in this setting. Core elements of ARCHES include enhanced contraceptive counseling that addresses RC, opportunity for patient disclosure of RC and IPV (and subsequent warm referral to local services), and provision of a palm-sized educational booklet.
METHODS


A matched-pair cluster control trial is being conducted to assess whether the ARCHES intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control condition), reduces RC and IPV, and improves contraceptive outcomes for woman and girls of reproductive age (15 to 49 years) seeking contraceptive services from community-based clinics in Nairobi, Kenya. All six clinics were assigned to intervention-control pairs based on similarities in patient volume and demographics, physical structure and neighborhood context. Survey data will be collected from patients immediately prior to their clinic visit (baseline, T1), immediately after their clinic visit (exit), and at 3- and 6-months post-visit (T2 and T3, respectively).
DISCUSSION


This study is the first to assess the efficacy of an adaptation of the ARCHES model to reduce GBV and improve reproductive health outside of the U.S., and one of only a small number of controlled trials to assess reductions in GBV associated with a clinic-based program in an LMIC context. Evidence from this trial will inform health system efforts to reduce GBV, and to enhance female contraceptive control and reproductive health in Kenya and globally.
TRIAL REGISTRATION


Registered May 23, 2018 - ClinicalTrials.gov, NCT03534401. Unique Protocol ID: 170084.",2020,"To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
","['women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya', 'woman and girls of reproductive age (15 to 49\u2009years) seeking contraceptive services from community-based clinics in Nairobi, Kenya']","['ARCHES\xa0intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control\xa0condition']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],6.0,0.0689499,"To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
","[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Uysal', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA. juysal@ucsd.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carter', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boyce', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Liambila', 'Affiliation': 'Population Council, Avenue 5, 3rd Floor, Rose Avenue, Nairobi, Kenya.'}, {'ForeName': 'Chi-Chi', 'Initials': 'CC', 'LastName': 'Undie', 'Affiliation': 'Population Council, Avenue 5, 3rd Floor, Rose Avenue, Nairobi, Kenya.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Muketo', 'Affiliation': 'Family Health Options Kenya, Family Health Plaza, Mai Mahiu Rd, Nairobi, Kenya.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Adhiambo', 'Affiliation': 'Family Health Options Kenya, Family Health Plaza, Mai Mahiu Rd, Nairobi, Kenya.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'International Planned Parenthood Federation, 4 Newhams Row, London, SE1 3UZ, UK.'}, {'ForeName': 'Seri', 'Initials': 'S', 'LastName': 'Wendoh', 'Affiliation': 'International Planned Parenthood Federation, 4 Newhams Row, London, SE1 3UZ, UK.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}]",Reproductive health,['10.1186/s12978-020-00916-9']
2510,32460790,Higher doses of a green tea-based supplement increase post-exercise blood flow following an acute resistance exercise bout in recreationally resistance-trained college-aged men.,"BACKGROUND


There are animal data suggesting green tea can enhance blood flow. However, human data are lacking. Thus, the purpose of this study was to examine the acute effects of low and high doses of a green tea-based supplement (GBS) on brachial artery blood flow before and following a resistance exercise bout.
METHODS


In this, double-blinded placebo-controlled trial, college-aged males (n = 18) who self-reported recreationally resistance training for the previous 6 ± 3 years were assigned to one of two studies including a low (300 mg serving) (n = 9) or high dose (600 mg serving) (n = 8; 1 drop) GBS study. During testing sessions, participants reported to the laboratory following an overnight fast and rested in a supine position for 15 min. Thereafter, baseline measurements for resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF) were obtained (PRE). Participants then consumed either their respective GBS dose or a similar placebo dose (microcrystalline cellulose) in a supine resting state. HR, SBP, DBP, BAD and BBF were measured 45 min after placebo or GBS ingestion (PRE2). Participants were then placed in a recumbent position and performed 4 sets of 10 arm curl repetitions using an 11 kg dumbbell. Participants returned to a supine position and HR, SBP, DBP, BAD and BBF were obtained within the first 3 min following exercise (POST), 15 min after exercise (15POST), and 45 min after exercise (45POST). Participants returned to the laboratory 24-48 h later to repeat the same protocol with either GBS or the placebo depending on randomization. Two-way (supplement x time) repeated measures ANOVAs were used to compare dependent variables between testing sessions for Study 1 (300 mg of GBS and placebo) and Study 2 (600 mg of GBS and placebo), and statistical significance was set at p < 0.05. No statistical comparisons were made between studies.
RESULTS


As expected, exercise increased BAD and BBF compared to resting baseline measured irrespective of supplementation. In addition, BAD and BBF did not differ between GBS and placebo at any time point after exercise in Study 1. In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
CONCLUSIONS


These data suggest a higher dose of GBS can enhance localized blood flow acutely following a resistance exercise bout. However, the long-term implications of these data are unclear, and more well-powered studies are needed to validate efficacy and elucidate potential mechanisms.",2020,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
","['college-aged males (n\u2009=\u200918) who self-reported recreationally resistance training for the previous 6\u2009±\u20093\u2009years', 'recreationally resistance-trained college-aged men']","['GBS and placebo', 'placebo dose (microcrystalline cellulose', 'green tea-based supplement (GBS', 'GBS', 'placebo (placebo', 'green tea-based supplement increase post-exercise blood flow', 'placebo']","['brachial artery blood flow', 'BAD and BBF', 'supine position and HR, SBP, DBP, BAD and BBF', 'baseline-normalized BBF', 'resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF', 'HR, SBP, DBP, BAD and BBF', 'blood flow']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",,0.322958,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
","[{'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Fox', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Garner', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Petey W', 'Initials': 'PW', 'LastName': 'Mumford', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, Saint Charles, MO, USA.'}, {'ForeName': 'Darren T', 'Initials': 'DT', 'LastName': 'Beck', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roberts', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA. mdr0024@auburn.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00358-5']
2511,32460793,Influence of daily beer or ethanol consumption on physical fitness in response to a high-intensity interval training program. The BEER-HIIT study.,"BACKGROUND


High-intensity interval training (HIIT) is an effective approach to improve physical fitness, but consuming beer, which is a regular practice in many physically active individuals, may interfere with these effects. The purposes of this study were to investigate the effects of a 10-week (2 days/week) HIIT program on cardiorespiratory fitness, muscle strength and power parameters, and also to assess the possible influence on them of a moderate consumption of beer (at least from Monday to Friday) or its alcohol equivalent.
METHODS


Young (24 ± 6 years old) healthy adults (n = 73, 35 females) were allocated to five groups. Four groups participated in the HIIT intervention program while the fifth group was a control Non-Training group (n = 15). Participants in the training groups chose whether they preferred receiving alcohol or alcohol-free beverages. Those choosing alcohol were randomized to either beer or ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n = 13) or (ii) T-Ethanol (sparkling water with vodka, 5.4%; n = 14). Those choosing alcohol-free intake were randomized to (iii) T-Water group (sparkling water, 0.0%; n = 16), or (iv) T-0.0Beer group (alcohol-free beer, 0.0%; n = 15). Men ingested 330 ml of the beverage at lunch and 330 ml at dinner; women ingested 330 ml at dinner. Before and after the intervention, maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps were measured.
RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength. These positive effects were not influenced by the regular intake of beer or alcohol. No changes in the vertical jumps occurred in any of the groups.
CONCLUSIONS


A moderate beer or alcohol intake does not mitigate the positive effect of a 10-week HIIT on physical fitness in young healthy adults.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03660579. Registered 20 September 2018. Retrospectively registered.",2020,"RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","['young healthy adults', 'Young (24\u2009±\u20096\u2009years old) healthy adults (n\u2009=\u200973, 35 females']","['beverage at lunch and 330\u2009ml at dinner; women ingested 330\u2009ml at dinner', 'HIIT intervention program', 'control Non-Training group', 'High-intensity interval training (HIIT', 'HIIT program', 'ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n\u2009=\u200913) or (ii) T-Ethanol', 'ethanol consumption', 'alcohol or alcohol-free beverages']","['absolute and relative values of VO 2 max, and total test duration', 'vertical jumps', 'physical fitness', 'maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps', 'cardiorespiratory fitness, muscle strength and power parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429930', 'cui_str': 'Test duration'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0166359,"RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Molina-Hidalgo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. criismh@correo.ugr.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dote-Montero', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. amarof@ugr.es.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00356-7']
2512,32460799,Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.,"BACKGROUND


Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.
METHODS


A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week ""Selge"" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models.
DISCUSSION


The ""Selge"" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.",2020,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"['600 individuals', 'alcohol misuse in Estonia']","['cognitive behavioural therapy (CBT) and motivational interviewing (MI', 'minimal-guidance online self-help intervention']","['number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health', 'change in the Alcohol Use Disorders Identification Test (AUDIT) score']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",600.0,0.0620665,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"[{'ForeName': 'Esta', 'Initials': 'E', 'LastName': 'Kaal', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia. esta.kaal@tai.ee.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Ülesoo', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Noormets', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kilp', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}]",BMC public health,['10.1186/s12889-020-08791-6']
2513,32460801,The addition of β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation does not improve anthropometric and performance maintenance across a collegiate rugby season.,"BACKGROUND


Muscular damage sustained while playing rugby may hinder performance across a season. β-Hydroxy β-Methylbutyrate (HMB) may help attenuate muscle damage and maintain lean mass and performance. This study sought to determine the effect of combining HMB with creatine monohydrate supplementation on measures of stress and muscle damage, body composition, strength and sprinting kinetics throughout a rugby season.
METHODS


This double-blind, cross-over investigation recruited 16 male collegiate rugby players to provide resting blood samples and complete assessments of body composition, strength and sprinting performance prior to their fall season (PRE FALL ). After testing, the athletes were matched for fat-free mass and assigned to consume one of two supplementation regimens for 6 weeks: 5 g HMB + 5 g creatine per day (HMB-Cr: 20.9 ± 1.1 years; 177 ± 2 cm; 88.4 ± 4.9 kg) or 5 g creatine + 5 g placebo per day (Cr: 21.4 ± 2.1 years; 179 ± 2 cm; 88.3 ± 4.9 kg). After 6 weeks (POST FALL ), PRE FALL  testing was repeated in 13 of the original 16 athletes before a 10-wk wash-out period. Athletes who returned for the spring season (n = 8) repeated all fall-season procedures and testing prior to (PRE SPRING ) and following (POST SPRING ) their 6-wk spring season, except they were assigned to the opposite supplementation regimen.
RESULTS


Linear mixed models with repeated measures revealed group x time interactions (p <  0.05) for observed for several measures but did not consistently and positively favor one group. During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring. In the spring, greater knee flexor rate of torque development (~ 149 Nm·sec - 1 , p = 0.003) and impulse (~ 4.5 Nm·sec, p = 0.022) were observed in Cr at PRE SPRING  but not at POST SPRING . Although significant interactions were found for cortisol concentrations, vastus lateralis pennation angle, and sprinting force, post-hoc analysis only revealed differences between fall and spring seasons. No other differences were observed.
CONCLUSIONS


The combination of HMB and creatine monohydrate supplementation does not provide a greater ergogenic benefit compared to creatine monohydrate supplementation alone. Body composition, strength, and sprinting ability did not change across the season with creatine monohydrate supplementation.",2020,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.",['16 male collegiate rugby players'],"['β-Hydroxy β-Methylbutyrate (HMB', 'β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation', 'HMB and creatine monohydrate supplementation', 'HMB\u2009+\u20095\u2009g creatine per day (HMB-Cr: 20.9\u2009±\u20091.1\u2009years; 177\u2009±\u20092\u2009cm; 88.4\u2009±\u20094.9\u2009kg) or 5\u2009g creatine +\u20095\u2009g placebo', 'HMB with creatine monohydrate supplementation']","['measures of stress and muscle damage, body composition, strength and sprinting kinetics', 'knee extensor peak torque', 'body composition, strength and sprinting performance prior to their fall season (PRE FALL ', 'Body composition, strength, and sprinting ability', 'knee flexor rate of torque development', 'cortisol concentrations, vastus lateralis pennation angle, and sprinting force']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",16.0,0.209374,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.","[{'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia. gmangine@kennesaw.edu.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Hester', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Julian', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Feito', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00359-4']
2514,32460804,Views among Malawian women about joining HIV prevention clinical trials when pregnant.,"BACKGROUND


The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.
METHODS


We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach.
RESULTS


A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions.
CONCLUSIONS


The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.",2020,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","['35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa', 'Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy']",['oral PrEP (Truvada) (2) a vaginal ring (dapivirine'],[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0574464', 'cui_str': 'Nyanja language'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]",[],3.0,0.0678425,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA. ksullivan@med.unc.edu.'}, {'ForeName': 'Tiwonge', 'Initials': 'T', 'LastName': 'Mtande', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Jaffe', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Health Behavior, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 170 Rosenau Hall, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Chifundo', 'Initials': 'C', 'LastName': 'Zimba', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Bioinformatics Building, 130 Mason Farm Road, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'The Kennedy Institute of Ethics, Georgetown University, 3700 O Street Northwest, Washington, DC, 20057, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Faden', 'Affiliation': 'Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Anne Drapkin', 'Initials': 'AD', 'LastName': 'Lyerly', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00271-6']
2515,32460811,Glioma patients in outpatient care-optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial.,"BACKGROUND


Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support. However, due to neurological and neurocognitive deficits, adequate assessment of distress and support needs remains challenging in clinical practice. The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap.
METHODS/DESIGN


This is a multicenter cluster randomized study with two arms. Randomization is done on a cluster level with 13 hospitals providing regular neuro-oncological outpatient services conducted by neurologists and/or neurosurgeons. The intervention will include an assessment of psychosocial distress of patients in doctor-patient conversation compared to assessment of psychosocial distress via questionnaire (control, standard of care). In total, 616 HGG patients will be enrolled. The outcome will be the number of HGG patients with increased psychosocial distress who receive professional support from psychosocial services. Secondary endpoints are inter alia number of patients reporting psychosocial distress and unmet needs detected correctly by the respective method; quality of life; psychological well-being and burden of the patients before and after doctor-patient consultation; as well as the length of the doctor-patient consultation.
DISCUSSION


Patients with HGG are confronted with an oncological diagnosis and at the same time with high symptom burden. This often leads to distress, which is not always adequately recognized and treated. So far, only a limited number of adequate instruments are available to assess HGG patient's distress. Yet, an adequate care and support network might facilitate the course of the disease and tumor therapies for patients. Our hypothesis is that an assessment conducted directly by attending doctors and in which the doctors talk to patients with HGG will be more effective than an assessment via a questionnaire, leading to better identifying patients in need of support. This may lead to an improvement of health care in these patients. Further, this method might be implemented also in other brain tumor patients (e.g., patients with brain metastases).
TRIAL REGISTRATION


German Clinical Trials Register, DRKS00018079. Registered on 3rd September 2019.",2020,"The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap.
","['616 HGG patients will be enrolled', 'Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support', '13 hospitals providing regular neuro-oncological outpatient services conducted by neurologists and/or neurosurgeons', 'Glioma patients in outpatient care-optimization of psychosocial care in neuro-oncological patients (GLIOPT']","['doctor-patient conversation compared to assessment of psychosocial distress via questionnaire (control, standard of care']","['psychosocial distress', 'inter alia number of patients reporting psychosocial distress and unmet needs detected correctly by the respective method; quality of life; psychological well-being and burden of the patients before and after doctor-patient consultation; as well as the length of the doctor-patient consultation']","[{'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0237427', 'cui_str': 'Neurosurgeon'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0740885', 'cui_str': 'Alias'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",616.0,0.0533018,"The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap.
","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Renovanz', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany. mirjam.renovanz@med.uni-tuebingen.de.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Hippler', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wehinger', 'Affiliation': 'Department of Neurology, Clinic Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Almuth F', 'Initials': 'AF', 'LastName': 'Keßler', 'Affiliation': 'Department of Neurosurgery, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts Der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'Nadji-Ohl', 'Affiliation': 'Department of Neurosurgery, Klinikum Stuttgart, Katharinenhospital (KH), Stuttgart, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Weiß Lucas', 'Affiliation': 'Center for Neurosurgery, University Hospital Cologne, Faculty of Medicine, University of Cologne, Köln, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Rapp', 'Affiliation': 'Department of Neurosurgery, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misch', 'Affiliation': 'Department of Neurosurgery, Charité - University Medical Center Berlin, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Coburger', 'Affiliation': 'Department of Neurosurgery, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Mehlitz', 'Affiliation': 'Department of Neurosurgery, Klinikum Barmherzige Brueder Trier, Trier, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Meixensberger', 'Affiliation': 'Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Keric', 'Affiliation': 'Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blettner', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schranz', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Singer', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}]",Trials,['10.1186/s13063-020-04321-2']
2516,32460816,"Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer.","INTRODUCTION


Neoadjuvant endocrine therapy (NET) has demonstrated efficacy in post-menopausal patients with hormone-responsive breast cancer. This trial was designed to compare the efficacy of neoadjuvant chemotherapy (NCT) with NET in pre-menopausal breast cancer.
PATIENTS AND METHODS


In this prospective, randomised, phase III study, oestrogen receptor (ER)-positive, HER2-negative, and lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea. Enrolled patients were randomly assigned (1:1) to receive 24 weeks of either NCT or NET with goserelin and tamoxifen. The primary purpose was to evaluate the non-inferiority of NET compared to NCT using clinical response, assessed by MRI. Besides, pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life were included as secondary endpoints.
RESULTS


A total of 187 patients were assigned to receive NCT (n = 95) or NET (n = 92), and 87 patients in each group completed treatments. More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046). Three NCT patients (3.4%) and one NET patient (1.2%) showed pCR (p < 0.005). No difference existed in the conversion rate of BCS (13.8% for NCT vs. 11.5% for NET, p = 0.531) and Ki-67 change (p = 0.114) between the two groups. Nineteen NCT patients had treatment-related grade 3 or worse events compared with none in the NET group.
CONCLUSIONS


Better clinical responses were observed in pre-menopausal patients after 24 weeks of NCT compared to those observed after NET.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT01622361. Registration June 19, 2012.",2020,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","['pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer', 'post-menopausal patients with hormone-responsive breast cancer', 'lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea', 'A total of 187 patients']","['NCT or NET with goserelin and tamoxifen', 'NCT', 'Neoadjuvant endocrine therapy (NET', 'NET', 'neoadjuvant endocrine therapy', 'neoadjuvant chemotherapy (NCT) with NET', 'neoadjuvant chemotherapy']","['Ki-67 change', 'pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life', 'conversion rate of BCS', 'complete response or partial response']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",187.0,0.239105,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","[{'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea.'}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Center for Breast Cancer, Research and Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, School of Medicine, Ajou University, Suwon, South Korea.'}, {'ForeName': 'Lee Su', 'Initials': 'LS', 'LastName': 'Kim', 'Affiliation': 'Division of Breast and Endocrine Surgery, Hallym Sacred Heart Hospital, College of Medicine, Hallyum University, Anyang, South Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Surgery and Cancer Research Institute, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Gyung -Yub', 'Initials': 'G-', 'LastName': 'Gong', 'Affiliation': 'Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hwa Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sei Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea. ahnsh@amc.seoul.kr.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01288-5']
2517,32460818,Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial.,"BACKGROUND


Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty.
METHODS


The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 10 9 /L, MASCC (Multinational Association of Supportive Care in Cancer) score ≥ 21 and receiving IV piperacillin/tazobactam or meropenem for less than 24 h are eligible to participate. Patients are randomised 1:1 either (i) to switch to oral ciprofloxacin and co-amoxiclav within 12-24 h of commencing intravenous antibiotics, completing at least 5 days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48 h, with ongoing antibiotics being continued at the physician's discretion (control). Patients are discharged home when their physician deems it appropriate. The primary outcome measure is a composite of treatment failures as assessed at day 14. The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death. Based on a 15% treatment failure rate in the control group and a 15% non-inferiority margin, the recruitment target is 230 patients.
DISCUSSION


If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis.
TRIAL REGISTRATION


ISRCTN: 84288963. Registered on the 1 July 2015. https://doi.org/10.1186/ISRCTN84288963. EudraCT: 2015-002830-35.",2020,"The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death.","['patients receiving systemic anti-cancer treatment', '16\u2009years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of >\u200938\u2009°C, neutrophil count ≤ 1.0\u2009×\u200910 9 /L, MASCC (Multinational Association of Supportive Care in Cancer) score\u2009≥\u200921 and receiving IV', 'for less than 24\u2009h are eligible to participate', 'Patients ≥', 'patients with cancer who have low-risk neutropenic sepsis', 'cancer patients with low-risk neutropenic sepsis']","['piperacillin/tazobactam or meropenem', 'early switching from intravenous to oral antibiotics', ""oral ciprofloxacin and co-amoxiclav within 12-24\u2009h of commencing intravenous antibiotics, completing at least 5\u2009days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48\u2009h, with ongoing antibiotics being continued at the physician's discretion (control"", 'oral antibiotic therapy', 'EudraCT']","['patient quality of life and resource savings', 'composite of treatment failures', 'failure rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}]","[{'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559681', 'cui_str': 'Oral antibiotic therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.197475,"The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Forde', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Lisburn Road, Belfast, BT9 7AE, UK. cforde01@qub.ac.uk.""}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'McMullan', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Translational Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grayson', 'Affiliation': 'Northern Ireland Cancer Research Consumer Forum, Belfast, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Doran', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Danny F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': 'The Wellcome Wolfson Institute for Experimental Medicine, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Thomas', 'Affiliation': 'Leicester Cancer Research Centre, Leicester, UK.'}, {'ForeName': 'Rosemary A', 'Initials': 'RA', 'LastName': 'Barnes', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Cardiff University and Velindre NHS Trust, Cardiff, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Coyle', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Lisburn Road, Belfast, BT9 7AE, UK.""}]",Trials,['10.1186/s13063-020-04241-1']
2518,32460840,A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol for a randomized controlled trial.,"BACKGROUND


Suffering linked to previous interpersonal trauma is common among patients in mental health care. Diagnostic labels may vary, but the clinical picture is often characterized by long-lasting and complex psychological and somatic symptoms, subjective distress and reduced quality of health and life. A substantial proportion of patients do not recover after individual treatment in ordinary specialized mental healthcare settings, despite the proven usefulness of individual trauma-specific treatments. The therapeutic factors that arise in group settings, such as normalization, shame reduction and corrective relational experiences, may be particularly useful for trauma survivors. However, evidence in support of group treatment for trauma survivors is scarce. This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
METHODS


In a single-site, non-blinded, randomized controlled trial (RCT), the effect of a combined group-based stabilization and skill-training (SST) intervention added to individual treatment will be compared to conventional treatment (treatment as usual, TAU) alone. Participants (N = 160) with ongoing and long-lasting reactions related to known adverse life events from the past will be recruited among patients at general outpatient clinics in a community mental health centre at St. Olav's University Hospital, Trondheim, Norway. Following baseline assessment and randomization, participants will complete follow-up measures at 4, 8, 13 and 19 months post-baseline. The primary outcome is personal recovery (The questionnaire about the process of recovery , QPR). Secondary outcomes include (1) self-reported symptoms of posttraumatic stress, general mental and somatic health symptoms, well-being, functional impairment and client satisfaction, (2) immunological and endocrine response measured in blood samples and (3) national registry data on occupational status, use of mental health services and pharmacological treatment. Additionally, mechanisms of change via posttraumatic cognitions will be examined.
DISCUSSION


The addition of a group-based intervention to individual treatment for trauma survivors might prove to be an efficient way to meet the need of long-lasting high-intensity treatment in a large group of patients in mental health care, thereby reducing their suffering and increasing their psychosocial functioning.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03887559. Registered on 25 March 2019.",2020,"This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
","[""Participants (N\u2009=\u2009160) with ongoing and long-lasting reactions related to known adverse life events from the past will be recruited among patients at general outpatient clinics in a community mental health centre at St. Olav's University Hospital, Trondheim, Norway"", 'ordinary community mental health hospital', 'patients in mental health care', 'patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol']","['combined group-based stabilization and skill-training (SST) intervention', 'combined individual and group-based stabilization and skill training intervention']","['1) self-reported symptoms of posttraumatic stress, general mental and somatic health symptoms, well-being, functional impairment and client satisfaction, (2) immunological and endocrine response measured in blood samples and (3) national registry data on occupational status, use of mental health services and pharmacological treatment', 'personal recovery (The questionnaire about the process of recovery , QPR']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0014006', 'cui_str': 'Occupational Status'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",,0.171637,"This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
","[{'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Holgersen', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway. katrine.hoyer.holgersen@stolav.no.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Brønstad', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brattland', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Hassel', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arentz', 'Affiliation': 'Department of Mental Health (IPH), Faculty of Medicine and Health Sciences, NTNU, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lara-Cabrera', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Skjervold', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}]",Trials,['10.1186/s13063-020-04297-z']
2519,32460875,Correction to: Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""patients with Parkinson's disease""]",['robot-assisted gait training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]",[],,0.0670688,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Min-Gu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Seo Jung', 'Initials': 'SJ', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Iee', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Haeng', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea. hgseo80@gmail.com.'}]",Trials,['10.1186/s13063-020-04437-5']
2520,32460879,Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial.,"BACKGROUND


There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice.
METHODS/DESIGN


DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial.
DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.",2020,"DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","['In September 2019 the study began recruiting children aged 6\u2009months to 18\u2009years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72\u2009h of gastroenteritis symptoms and who were administered a dose of', 'six Canadian pediatric emergency departments (EDs', '1030 children (1:1 allocation via an internet-based, third-party, randomization service', 'children presenting to emergency departments with vomiting secondary to acute gastroenteritis', 'children focusing on post-emergency department visit and patient-centered outcomes', 'children with acute gastroenteritis', 'Pediatric Gastroenteritis', 'pediatric Acute GastroEnteritis (DOSE-AGE']","['ondansetron', 'Multi-dose Oral Ondansetron', 'ondansetron oral solution or placebo', 'placebo']","['duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety', 'development of moderate-to-severe gastroenteritis in the 7\u2009days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1238268', 'cui_str': 'Ondansetron Oral Solution [Zofran]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1030.0,0.588411,"DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'The Hospital for Sick Children, Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'The Hospital for Sick Children, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hopkin', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Departments of Pediatric Emergency Medicine and Pediatrics, CHU Sainte-Justine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Plint', 'Affiliation': ""Children's Hospital of Eastern Ontario, Departments of Pediatric and Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dixon', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Women and Children's Health Research Institute, Edmonton, AB, Canada.""}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Beer', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Joubert', 'Affiliation': ""Division of Paediatric Emergency Medicine, Department of Paediatrics, Children's Hospital LHSC, Western University, London, ON, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics and the Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Divisions of Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04347-6']
2521,32460885,"A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial.","BACKGROUND


Parkinson's disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals' needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive.
METHODS/DESIGN


PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation.
PRIMARY OUTCOME


Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK.
DISCUSSION


The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.",2020,The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT.,"[""Parkinson's disease (PD) affects approximately 145,519 people in the UK"", ""Parkinson's disease"", 'Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled']","['NHS SLT or LSVT LOUD® via a central computer-generated programme', 'SLT', 'NHS SLT or LSVT LOUD®', 'NHS SLT', 'intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation', 'Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy', 'Speech and Language Therapy (SLT) intervention']","['Voice Handicap Index (VHI) total score', ""VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5\u2009L; ICECAP-O; resource utilisation; adverse events and carer quality of life""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}]","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",546.0,0.162409,The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT.,"[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Sackley', 'Affiliation': ""Population Health Sciences, Addison House, King's College London, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rick', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK. caroline.rick@nottingham.ac.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Au', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Beaton', 'Affiliation': 'Queen Elizabeth Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': 'School of Allied and Public Health Professions, Canterbury Christ church University, Canterbury, CT1 1QU, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dickson', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dowling', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hughes', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics, University of Birmingham, Birmingham,, B15 2TT, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Masterson-Algar', 'Affiliation': 'Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicoll', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': 'Division of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Clarke', 'Affiliation': 'Institute for Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04354-7']
2522,32460904,Dissociable hormonal profiles for psychopathology and stress in anorexia and bulimia nervosa.,"BACKGROUND


Anorexia nervosa (AN) and bulimia nervosa (BN) are complex psychiatric conditions, in which both psychological and metabolic factors have been implicated. Critically, the experience of stress can precipitate loss-of-control eating in both conditions, suggesting an interplay between mental state and metabolic signaling. However, associations between psychological states, symptoms and metabolic processes in AN and BN have not been examined.
METHODS


Eighty-five women (n = 22 AN binge/purge subtype, n = 33 BN, n = 30 controls) underwent remote salivary cortisol sampling and a 2-day, inpatient study session to examine the effect of stress on cortisol, gut hormones [acyl-ghrelin, peptide tyrosine tyrosine (PYY) and glucagon-like peptide-1] and food consumption. Participants were randomized to either an acute stress induction or control task on each day, and plasma hormones were serially measured before a naturalistic, ad libitum meal.
RESULTS


Cortisol-awakening response was augmented in AN but not in BN relative to controls, with body mass index explaining the most variance in post-awakening cortisol (36%). Acute stress increased acyl-ghrelin and PYY in AN compared to controls; however, stress did not alter gut hormone profiles in BN. Instead, a group-by-stress interaction showed nominally reduced cortisol reactivity in BN, but not in AN, compared to controls. Ad libitum consumption was lower in both patient groups and unaffected by stress.
CONCLUSIONS


Findings extend previous reports of metabolic dysfunction in binge-eating disorders, identifying unique associations across disorders and under stress. Moreover, we observed disrupted homeostatic signaling in AN following psychological stress, which may explain, in part, the maintenance of dysregulated eating in this serious illness.",2020,"Acute stress increased acyl-ghrelin and PYY in AN compared to controls; however, stress did not alter gut hormone profiles in BN.","['anorexia and bulimia nervosa', 'Eighty-five women (n = 22 AN binge/purge subtype, n = 33 BN, n = 30 controls) underwent']","['acute stress induction or control task', 'stress on cortisol, gut hormones [acyl-ghrelin, peptide tyrosine tyrosine (PYY) and glucagon-like peptide-1] and food consumption', 'remote salivary cortisol sampling']","['Cortisol-awakening response', 'cortisol reactivity', 'Ad libitum consumption']","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0855227', 'cui_str': 'Purging'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",85.0,0.019485,"Acute stress increased acyl-ghrelin and PYY in AN compared to controls; however, stress did not alter gut hormone profiles in BN.","[{'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Westwater', 'Affiliation': ""Department of Psychiatry, University of Cambridge, Herchel Smith Building, Addenbrooke's Hospital, CambridgeCB2 0SZ, UK.""}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Mancini', 'Affiliation': 'Department of Engineering, Computational and Biological Learning Laboratory, University of Cambridge, CambridgeCB2 1PZ, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Shapleske', 'Affiliation': 'Adult Eating Disorders Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, CB21 5EF, UK.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Serfontein', 'Affiliation': 'Adult Eating Disorders Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, CB21 5EF, UK.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Ziauddeen', 'Affiliation': ""Department of Psychiatry, University of Cambridge, Herchel Smith Building, Addenbrooke's Hospital, CambridgeCB2 0SZ, UK.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': ""Department of Psychiatry, University of Cambridge, Herchel Smith Building, Addenbrooke's Hospital, CambridgeCB2 0SZ, UK.""}]",Psychological medicine,['10.1017/S0033291720001440']
2523,32460928,Impact of an automated hand hygiene monitoring system combined with a performance improvement intervention on hospital-acquired infections.,"OBJECTIVE


Hand hygiene adherence has been associated with reductions in nosocomial infection. We assessed the effect of improvements in electronically measured hand hygiene adherence on the incidence of hospital-acquired infections.
METHODS


This quasi-experimental study was conducted in a 555-bed urban safety-net level I trauma center. The preintervention period was January 2015 through June 2016. Baseline electronic hand hygiene data collection took place from April through June 2016. The intervention period was July 2016 through December 2017. An electronic hand hygiene system was installed in 4 locations in our hospital. Performance improvement strategies were implemented that included education, troubleshooting, data dissemination, and feedback. Adherence rates were tracked over time. Rates of hospital-acquired infections were evaluated in the intervention units and in control units selected for comparison. The intervention period was subdivided into the initial and subsequent 9-month periods and were compared to the baseline period.
RESULTS


Electronically measured hand hygiene rates improved significantly from baseline to intervention, from 47% 77% adherence. Rates >70% continued to be measured 18 months after the intervention. Interrupted time series analysis indicated a significant effect of hand hygiene on healthcare facility-onset Clostridioides difficile infection rates during the first 9 months of the intervention. This trend continued during the final 9 months of the intervention but was nonsignificant. No effects were observed for other hospital-acquired infection rates.
CONCLUSIONS


Implementation of electronic hand hygiene monitoring and performance improvement interventions resulted in reductions in hospital-onset Clostridioides difficile infection rates.",2020,Interrupted time series analysis indicated a significant effect of hand hygiene on healthcare facility-onset Clostridioides difficile infection rates during the first 9 months of the intervention.,['555-bed urban safety-net level I trauma center'],['automated hand hygiene monitoring system combined with a performance improvement intervention'],"['Adherence rates', 'hospital-acquired infections', 'healthcare facility-onset Clostridioides difficile infection rates', 'Rates of hospital-acquired infections', 'hospital-acquired infection rates', 'hygiene rates', 'hospital-onset Clostridioides difficile infection rates']","[{'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.07351,Interrupted time series analysis indicated a significant effect of hand hygiene on healthcare facility-onset Clostridioides difficile infection rates during the first 9 months of the intervention.,"[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Knepper', 'Affiliation': 'Department of Patient Safety and Quality, Denver Health Medical Center, Denver, Colorado.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Miller', 'Affiliation': 'Department of Patient Safety and Quality, Denver Health Medical Center, Denver, Colorado.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Young', 'Affiliation': 'Department of Patient Safety and Quality, Denver Health Medical Center, Denver, Colorado.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.182']
2524,32460989,"Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study.","BACKGROUND


Sodium hyaluronate has been proposed as a treatment for improving the symptoms of chronic rhinosinusitis. The present study evaluated the effect of the intranasal administration of hyaluronic acid in a group of patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP).
MATERIALS AND METHODS


Thirty subjects aged 18-65 years affected by CRSsNP were enrolled. The subjects were randomly administered hyaluronic acid or isotonic saline solution by nasal nebulizer twice per day for 30 days. They were evaluated before (T0) and after the treatment (T1) with Sino-Nasal Outcome Test-22, visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology.
RESULTS


Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters. Being included in the study group rather than in the control group did not have a significant effect on the variation of the considered parameters between T0 and T1. Considering the effects of the micronized douches independently from the type of solution used (either hyaluronic acid or isotonic saline solution), although no difference emerged between study and control group for any of the objective parameters, there was an improvement of Sino-Nasal Outcome Test-22 scores (p = .0005), visual analogue scale for nasal obstruction (p = .0006) and for hyposmia/hypogeusia (p = .04).
CONCLUSIONS


The treatment with micronized nasal douches can improve the sino-nasal symptoms of CRSsNP, in particular nasal obstruction and olfactory ability. No advantage of the use of hyaluronic acid over isotonic saline solution emerged.",2020,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","['Thirty subjects aged 18-65\xa0years affected by CRSsNP were enrolled', 'non-polipoid chronic rhinosinusitis', 'patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP']","['micronized nasal irrigations with hyaluronic acid/isotonic saline solution', 'hyaluronic acid', 'hyaluronic acid or isotonic saline solution']","['Sino-Nasal Outcome Test-22 scores', 'visual analogue scale for nasal obstruction', 'objective and subjective parameters', 'sino-nasal symptoms of CRSsNP', 'visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0151934', 'cui_str': 'Hypogeusia'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0430616', 'cui_str': 'Active anterior rhinomanometry'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]",30.0,0.0947609,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Savietto', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Marioni', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Maculan', 'Affiliation': 'Department of Cardiac Thoracic and Vascular Sciences and Public Health, Hygiene and Public Health Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pettorelli', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scarpa', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy; Department of Mathematics ""Tullio Levi-Civita"", University of Padova, Padova, Italy.'}, {'ForeName': 'Edi', 'Initials': 'E', 'LastName': 'Simoni', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Astolfi', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Marchese-Ragona', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ottaviano', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy. Electronic address: giancarlo.ottaviano@unipd.it.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102502']
2525,32460997,An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275.,"OBJECTIVES


Methotrexate and actinomycin-D are both effective first-line drugs for low-risk (WHO score 0-6) Gestational Trophoblastic Neoplasia (GTN) with considerable debate about which is more effective, less toxic, and better tolerated. The primary trial objective was to test if treatment with multi-day methotrexate (MTX) was inferior to pulse actinomycin-D (ACT-D). Secondary objectives included evaluation of severity and frequency of adverse events, and impact on quality of life (QOL).
METHODS


This was a prospective international cooperative group randomized phase III two arm non-inferiority study (Clinical Trials Identifier: (NCT01535053). The control arm was ACT-D; the experimental arm was multi-day MTX regimen (institutional preference of 5 or 8 day). Outcome measures included complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items.
RESULTS


The complete response rates for multi-day methotrexate and pulse actinomycin-D were 88% (23/26 patients) and 79% (22/28 patients) (p = NS) respectively, there were two recurrences in each arm, and 100% of patients survived. Significant toxicity was minimal, but mouth sores (mucositis), and eye pain were significantly more common in the MTX arm (p = 0.001 and 0.01 respectively). Quality of life showed no significant difference in overall quality of life, body image, sexual function, or treatment related side effects. The study was closed for low accrual rate (target 384, actual accrual 57), precluding statistical analysis of the primary objective.
CONCLUSIONS


The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance. The multi-day MTX regimens were associated with significantly more mucositis and were significantly less convenient.",2020,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.",['low risk gestational trophoblastic neoplasia; NRG/GOG 275'],"['pulse actinomycin-D (ACT-D', 'pulse actinomycin-D versus multi-day methotrexate', 'MTX', 'multi-day methotrexate (MTX', 'Methotrexate and actinomycin-D']","['complete response rates', 'mouth sores (mucositis), and eye pain', 'mucositis', 'evaluation of severity and frequency of adverse events, and impact on quality of life (QOL', 'Significant toxicity', 'overall quality of life, body image, sexual function, or treatment related side effects', 'complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items', 'complete response rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1135868', 'cui_str': 'Gestational trophoblastic neoplasia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.121683,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Schink', 'Affiliation': 'Cancer Treatment Centers of America, Comprehensive Care and Research Center, Chicago, IL, USA. Electronic address: Julian.schink@CTCA-hope.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tidy', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: John.Tidy@sth.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: matthew.winter@sth.nhs.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, USA. Electronic address: carterj@mskcc.org.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: naanders@nm.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moxley', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, OK, USA. Electronic address: Katherine-Moxley@ouhsc.edu.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yabuno', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan. Electronic address: yabunoakira@yahoo.co.jp.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Taylor', 'Affiliation': 'Gynecologic Oncology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address: taylorse@upmc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kushnir', 'Affiliation': ""Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: ckushnir@wccenter.com.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Horowitz', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nhorowitz@partners.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.013']
2526,32461013,"Effects of school-based meditation courses on self-reflection, academic attention, and subjective well-being in South Korean middle school students.","PURPOSE


The purpose of this study was to examine the effects of school-based meditation courses on middle school students' self-reflection, academic attention (ability to focus in classrooms), and subjective well-being.
DESIGN AND METHODS


The research design was a nonequivalent group comparison (n = 163) with pretest and post-test. The experimental group (n = 81) was given an eight-week meditation course and the control group (n = 82) was given other elective courses such as calligraphy and reading.
RESULTS


The experimental group showed significant increases in self-reflection (t = 2.536, p = .012) and academic attention (t = 2.767, p = .006), but subjective well-being did not increase significantly (t = 0.906, p = .367). Life satisfaction was the only subcomponent of subjective well-being that increased significantly (t = 2.438, p = .016); the other subjective well-being subcomponents did not show any significant changes.
CONCLUSIONS


Self-reflection and academic attention significantly increased in middle school students after an eight-week meditation course. Even though changes in subjective well-being were not significant, one of its subcomponents (life satisfaction) did show significant improvement. Self-reflection and subjective well-being were shown to be influential factors for academic attention (48.5% of the variance explained).
PRACTICE IMPLICATIONS


This study is meaningful in that it examined positive benefits of a meditation course in middle school students and explored the feasibility of such a course in a school system.",2020,"The experimental group showed significant increases in self-reflection (t = 2.536, p = .012) and academic attention (t = 2.767, p = .006), but subjective well-being did not increase significantly (t = 0.906, p = .367).","['middle school students', 'South Korean middle school students']","['school-based meditation courses', 'elective courses such as calligraphy and reading']","['Life satisfaction', 'self-reflection, academic attention (ability to focus in classrooms), and subjective well-being', 'self-reflection', 'academic attention']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",163.0,0.0130779,"The experimental group showed significant increases in self-reflection (t = 2.536, p = .012) and academic attention (t = 2.767, p = .006), but subjective well-being did not increase significantly (t = 0.906, p = .367).","[{'ForeName': 'Mi Ra', 'Initials': 'MR', 'LastName': 'Yun', 'Affiliation': 'Department of Nursing, Chung-Ang University, South Korea.'}, {'ForeName': 'Namin', 'Initials': 'N', 'LastName': 'Shin', 'Affiliation': 'Department of Education, Dongguk University, South Korea.'}, {'ForeName': 'Hyeyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Culinary Arts, Woosong University, South Korea.'}, {'ForeName': 'In Sook', 'Initials': 'IS', 'LastName': 'Jang', 'Affiliation': 'Academic Society for Human Completion, South Korea.'}, {'ForeName': 'Mi Jin', 'Initials': 'MJ', 'LastName': 'Ha', 'Affiliation': 'Bansong Middle School, South Korea.'}, {'ForeName': 'Boas', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Henry P. Becton School of Nursing and Allied Health, Fairleigh Dickinson University, USA. Electronic address: byu@fdu.edu.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.05.002']
2527,32461015,Comparison of short-term efficacy of transanal total mesorectal excision and laparoscopic total mesorectal excision in low rectal cancer.,"BACKGROUND/OBJECTIVE


The transanal total mesorectal excision(TaTME) of rectal malignancies is largely referred to as treatment of mid to low, especially low rectal cancer. This study was to compare the short-term efficacy of TaTME and laparoscopic total mesorectal excision (LaTME) for low rectal cancer.
METHODS


A prospective study of patients with low rectal cancer who underwent laparoscopic radical surgery at the General Surgery of Guangzhou Red Cross Hospital from January 2017 to December 2019 was performed. The general information, perioperative results and pathological results of the two groups were compared.
RESULTS


A total of 64 patients were included in the study, 32 in the TaTME group and 32 in the LaTME group. The clinical characteristics of the two groups was comparable (P > 0.05). The operation time in the TaTME group was longer than that in the LaTME group (212.59 ± 28.71min vs 187.66 ± 27.15min, P = 0.001), no significant differences were seen in the conversion rate, intraoperative complications, morbidity, serious morbidity, anastomotic leak, unplanned reoperation and hospital stay(P > 0.05). The circumferential resection margin (CRM) distance in the TaTME group was longer than that in the LaTME group (6.81 ± 2.99 mm vs 5.21 ± 3.06 mm, P = 0.039). The inter-group difference in terms of harvested lymph nodes, mesorectum integrity, CRM involvement, DRM distance, R1 resection, complete remission, pathological T stage, pathological N stage and pathological TNM stage was not significant (P > 0.05).
CONCLUSIONS


TaTME is a promising surgical technique and maybe offers a safe and feasible alternative to LaTME in managing low rectal cancer.",2020,"The circumferential resection margin (CRM) distance in the TaTME group was longer than that in the LaTME group (6.81 ± 2.99 mm vs 5.21 ± 3.06 mm, P = 0.039).","['patients with low rectal cancer who underwent laparoscopic radical surgery at the General Surgery of Guangzhou Red Cross Hospital from January 2017 to December 2019 was performed', 'low rectal cancer', '64 patients were included in the study, 32 in the TaTME group and 32 in the LaTME group']","['LaTME', 'TaTME and laparoscopic total mesorectal excision (LaTME', 'transanal total mesorectal excision and laparoscopic total mesorectal excision', 'TaTME']","['conversion rate, intraoperative complications, morbidity, serious morbidity, anastomotic leak, unplanned reoperation and hospital stay(P\xa0>\xa00.05', 'circumferential resection margin (CRM) distance', 'harvested lymph nodes, mesorectum integrity, CRM involvement, DRM distance, R1 resection, complete remission, pathological T stage, pathological N stage and pathological TNM stage', 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0447562', 'cui_str': 'Mesorectum'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",64.0,0.0292002,"The circumferential resection margin (CRM) distance in the TaTME group was longer than that in the LaTME group (6.81 ± 2.99 mm vs 5.21 ± 3.06 mm, P = 0.039).","[{'ForeName': 'Jingqing', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of General Surgery, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou City, 510220, China.'}, {'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou City, 510220, China. Electronic address: 51242743@qq.com.'}, {'ForeName': 'Huixing', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou City, 510220, China.'}, {'ForeName': 'Bailin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou City, 510220, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou City, 510220, China.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.05.007']
2528,32461038,The Negative Impact of Psychotropic Drug Use on Quality of Life in Nursing Home Patients at Different Stages of Dementia: Cross-Sectional Analyses from the COSMOS Trial.,"OBJECTIVES


The quality of life (QoL) in nursing home (NH) patients with dementia is threatened by neuropsychiatric symptoms. This may trigger the use of psychotropic drugs, yet it is unknown if this practice improves the QoL. We investigated the association between the number of psychotropic drugs and QoL at different stages of dementia, adjusted for neuropsychiatric symptoms.
DESIGN


Cross-sectional analysis of baseline data from the COSMOS study, a multicenter, cluster-randomized, single-blinded, controlled trial.
SETTING AND PARTICIPATION


Four hundred thirty-one patients (aged ≥65 years) with and without dementia from 33 Norwegian NHs comprising 67 wards.
MEASURES


QoL assessed by Quality of Life in Late Stage Dementia (QUALID) and Quality of Life in Dementia (QUALIDEM), neuropsychiatric symptoms by Neuropsychiatric Inventory-Nursing Home version, and cognition by Mini-Mental State Examination.
RESULTS


At least 1 psychotropic drug was prescribed to 71% of the 431 participants included in the final sample. We estimated the trend in mean QoL scores over the number of psychotropic drugs in patients with clinical significant neuropsychiatric symptom load. QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001). No psychotropic drugs (mean QUALID score 20 ± 0.5, mean QUALIDEM score 40 ± 8.1) compared to ≥3 psychotropic drug (mean QUALID score 25 ± 7.8, mean QUALIDEM score 33 ± 8.0). This association was evident in mild, moderate, and severe dementia but absent in people without dementia. Use of antidepressant agents in mild and moderate dementia was associated with increased QoL compared with no use of antidepressant agents.
CONCLUSIONS AND IMPLICATIONS


Overall, our findings suggest that psychotropic drugs might pose a threat to QoL in NH patients at all stages of dementia, possibly with the exception of use of antidepressant agents in mild to moderate dementia. This underlines the need for updated knowledge on psychopharmacologic treatment and implementation of procedures for maintaining QoL in dementia care facilities.",2020,QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001).,"['nursing home (NH) patients with dementia is threatened by neuropsychiatric symptoms', 'Nursing Home Patients at Different Stages of Dementia', 'patients with clinical significant neuropsychiatric symptom load', 'Four hundred thirty-one patients (aged ≥65\xa0years) with and without dementia from 33 Norwegian NHs comprising 67 wards', '431 participants included in the final sample']",[],"['number of psychotropic drugs', 'quality of life (QoL', 'Quality of Life', 'Quality of Life in Late Stage Dementia (QUALID) and Quality of Life in Dementia (QUALIDEM), neuropsychiatric symptoms by Neuropsychiatric Inventory-Nursing Home version, and cognition by Mini-Mental State Examination', 'mean QoL scores']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",431.0,0.1136,QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001).,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ito', 'Affiliation': 'School of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Line Iden', 'Initials': 'LI', 'LastName': 'Berge', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; NKS Olaviken Gerontopsychiatric Hospital, Bergen, Norway.'}, {'ForeName': 'Bettina S', 'Initials': 'BS', 'LastName': 'Husebo', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Reidun K N M', 'Initials': 'RKNM', 'LastName': 'Sandvik', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; Faculty of Health and Social Sciences, Department of Nursing, Western Norway University of Applied Sciences, Bergen, Norway. Electronic address: rks@hvl.no.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.028']
2529,32461050,Hamstring strength and architectural adaptations following inertial flywheel resistance training.,"OBJECTIVES


To investigate the architectural and strength adaptations of the hamstrings following 6-weeks of inertial flywheel resistance training.
DESIGN


Randomised, stratified training intervention METHODS: Twenty healthy males undertook 6-weeks of a conventional (n=10) or eccentrically biased (n=10) flywheel leg-curl training intervention as well as a subsequent 4-week detraining period. Biceps femoris long head (BFlh) architecture was assessed weekly, whilst assessments of eccentric and isometric knee flexor strength and rate of force development (RFD) were conducted prior to and following the intervention and detraining periods.
RESULTS


The participants who undertook the eccentrically biased flywheel intervention showed a significant 14±5% (p<0.001, d=1.98) increase in BFlh fascicle length after 6-weeks of training. These improvements in fascicle length subsequently declined by 13±4% (p<0.001. d=-2.04) following the 4-week detraining period. The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods. Both groups saw no changes in any of the strength or RFD variables after the intervention or the detraining period.
CONCLUSIONS


Flywheel leg-curl training performed with an eccentric bias led to significant lengthening of BFlh fascicles without a change in RFD, eccentric or isometric strength. These increases in fascicle length were lost following a 4-week detraining period. Conventional flywheel leg-curl training resulted in no changes in fascicle length, strength and RFD. These findings suggest that additional eccentric bias is required during inertial flywheel resistance training to promote fascicle lengthening in the BFlh, however this may still be insufficient to cause alterations to strength and RFD.",2020,"The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods.",['Twenty healthy males undertook 6-weeks of a'],"['Conventional flywheel leg-curl training', 'conventional (n=10) or eccentrically biased (n=10) flywheel leg-curl training intervention', 'inertial flywheel resistance training']","['Biceps femoris long head (BFlh) architecture', 'Hamstring strength and architectural adaptations', 'fascicle length, strength and RFD', 'BFlh fascicle length', 'strength or RFD variables', 'RFD, eccentric or isometric strength', 'fascicle length', 'eccentric and isometric knee flexor strength and rate of force development (RFD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",20.0,0.0167128,"The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods.","[{'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Presland', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Opar', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; Sports Performance, Recovery, Injury and New Technologies (SPRINT) Research Centre, Australian Catholic University, Fitzroy, Victoria, Australia.'}, {'ForeName': 'Morgan D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': 'School of Health, Sport and Professional Practice, University of South Wales, Pontypridd, Wales, UK.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Hickey', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Lee Dow', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Bourne', 'Affiliation': 'School of Allied Health Sciences and Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Timmins', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; Sports Performance, Recovery, Injury and New Technologies (SPRINT) Research Centre, Australian Catholic University, Fitzroy, Victoria, Australia. Electronic address: Ryan.Timmins@acu.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.007']
2530,32461053,Topical ivermectin-metronidazole gel therapy in the treatment of blepharitis caused by Demodex spp.: A randomized clinical trial.,"PURPOSE


To evaluate the efficacy of topical ivermectin-metronidazole combined therapy in the management of Demodex-associatedblepharitis.
METHODS


Sixty patients with a diagnosis of Demodex-associatedblepharitis were recruited in a randomized clinical trial. Thirty receiving topical ivermectin (0.1%)-metronidazole (1%) gel treatment on days 0, 15 and 30. Thirty additional patients were used as a control group receiving vehicle on days 0, 15 and 30. The primary efficacy measure was the number of Demodex spp. mitesin the eyelashes of patients. The secondary outcomes included clinical improvement of signs and adverse events.
RESULTS


Complete eradication of Demodex spp. was found in 96.6% of patients in the treatment group. Furthermore, a significant reduction of inflammation signs were found in all treated patients versus controls. None of the patients experienced any adverse effects associated with the treatment.
CONCLUSION


Demodex infection was controlled satisfactorily with the ivermectin (0.1%)-metronidazole (1%) gel, and no adverse effects were observed. Application of this gel for the treatment of different parasitic infections of the eyelids could be feasible, and this requires further exploration.",2020,"RESULTS


Complete eradication of Demodex spp. was found in 96.6% of patients in the treatment group.","['Sixty patients with a diagnosis of Demodex-associatedblepharitis', 'blepharitis caused by Demodex spp']","['Topical ivermectin-metronidazole gel therapy', 'topical ivermectin (0.1%)-metronidazole (1%) gel treatment', 'ivermectin (0.1%)-metronidazole', 'topical ivermectin-metronidazole combined therapy']","['adverse effects', 'clinical improvement of signs and adverse events', 'inflammation signs', 'number of Demodex spp']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0323683', 'cui_str': 'Demodex'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0323683', 'cui_str': 'Demodex'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",30.0,0.0437704,"RESULTS


Complete eradication of Demodex spp. was found in 96.6% of patients in the treatment group.","[{'ForeName': 'Marcel Y', 'Initials': 'MY', 'LastName': 'Ávila', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Universidad Nacional de Colombia, Bogota, Colombia. Electronic address: myavilac@unal.edu.co.'}, {'ForeName': 'Dayron F', 'Initials': 'DF', 'LastName': 'Martínez-Pulgarín', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Universidad Nacional de Colombia, Bogota, Colombia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Rizo Madrid', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Universidad Nacional de Colombia, Bogota, Colombia.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.04.011']
2531,32461104,Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo.,"BACKGROUND


The predictive value of tumor mutational burden (TMB), alone or in combination with an immune gene expression profile (GEP), for response to neoadjuvant therapy in early triple negative breast cancer (TNBC) is currently not known, neither for immune checkpoint blockade (ICB) nor conventional chemotherapy.
PATIENTS AND METHODS


We obtained both whole exome sequencing and RNA-Seq data from pre-treatment samples of 149 TNBC of the recent neoadjuvant ICB trial GeparNuevo. In a predefined analysis, we assessed the predictive value of TMB and a previously developed immune GEP for pathological complete remission (pCR).
RESULTS


Median TMB was 1.52 mut/Mb (range 0.02-7.65) and was significantly higher in patients with pCR (median 1.87 vs. 1.39; P=0.005). In multivariate analysis, odds ratios for pCR per mut/Mb were 2.06 (95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively. We also found that both continuous TMB and immune GEP (or tumor infiltrating lymphocytes) independently predicted pCR. When we stratified patients in groups based on the upper tertile of TMB and median GEP, we observed a pCR rate of 82% (95% CI 60%-95%) in the group with both high TMB and GEP, in contrast to only 28% (95% CI 16%-43%) in the group with both low TMB and GEP.
CONCLUSIONS


TMB and immune gene expression profile add independent value for pCR prediction. Our results recommend further analysis of TMB in combination with immune parameters to individually tailor therapies in breast cancer.",2020,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.",['early triple negative breast cancer (TNBC'],[],"['pCR rate', 'Median TMB']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",[],"[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.160939,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany. Electronic address: t.karn@em.uni-frankfurt.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Holtrich', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum, München, Germany.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jank', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital, Ulm, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Rotkreuzklinikum, München, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital, Kiel, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Hospital, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital, Aachen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Comprehensive Cancer Center, Friedrich-Alexander University, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center of Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.015']
2532,32461117,The value of extensive catheter linear ablation on persistent atrial fibrillation (the CLEAR-AF Study).,"BACKGROUND


The ablation therapy for persistent atrial fibrillation (PerAF) is still a challenge due to the high recurrence rate. This study was aimed to investigate the value of extensive linear ablation with contact force sensing techniques for PerAF.
METHODS


A total of 214 patients with PerAF were enrolled in five centers. The patients were randomly assigned to Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines were added in both groups if the atrial fibrillation (AF) could not be terminated after all approaches above.
RESULTS


Acute success rate of AF termination during the ablation procedure in Group I was significantly higher than Group II (P=0.028). Two-years follow-up showed no significant difference in the sinus rhythm maintenance rate between the two groups (63.4% in group I vs. 57.2% in group II, P = 0.218). More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001). The Kaplan-Meier estimates of AF/AT-free survival after repeat ablation procedures were 76.2% in Group I and 47.1% in Group II (P=0.039).
CONCLUSIONS


Extensive linear ablation with contact force monitoring did not improve the long-term outcomes for PerAF patients. Repeat ablation procedure showed a possible higher chance of sinus rhythm restoration during follow-up.",2020,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","['PerAF patients', '214 patients with PerAF were enrolled in five centers']","['Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines', 'extensive catheter linear ablation']","['sinus rhythm restoration', 'sinus rhythm maintenance rate', 'organized atrial tachycardia (AT', 'AF termination']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",214.0,0.015255,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: ianyao@263.net.cn.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongpeng', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yuhe', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Erpeng', 'Initials': 'E', 'LastName': 'Liang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.032']
2533,32461125,Intradiscal glucocorticoids injection in chronic low back pain with active discopathy: a randomized controlled study.,"BACKGROUND


The benefit of an intradiscal injection of corticosteroids for low back pain with active discopathy is not totally resolved.
OBJECTIVE


The objective of this study was to estimate the clinical efficacy of an intradiscal injection of glucocorticoids versus lidocaine in patients with low back pain and active discopathy (Modic 1 changes).
METHODS


A prospective, single-blind, randomized controlled study was conducted in 2 tertiary care centers with spine units. We enrolled 50 patients (mean age 50 years; 46% women) with lumbar active discopathy on MRI and failure of medical treatment for more than 6 weeks. Participants were randomly assigned to receive an intradiscal injection of glucocorticoids (50 mg prednisolone acetate [GC group], n=24) or lidocaine (40 mg [L group], n=26) by senior radiologists. Outcome measures were low back pain in the previous 8 days (10-point visual analog scale), Dallas Pain Questionnaire, Oswestry Disability Index, analgesic treatment and work status at 1, 3 and 6 months as well as pain at 1, 2 and 3 weeks. The primary outcome was change in pain between baseline and 1 month.
RESULTS


Data for 39 patients (78%; 17 in the GC group, 22 in the L group) were analyzed for the primary outcome. Pain intensity was significantly reduced at 1 month in the GC versus L group (mean [SD] -2.7 [2.3] and +0.1 [2.0], p<0.001) but not at 3 and 6 months. At 1 and 3 months, the groups significantly differed in daily activities of the Dallas Pain Questionnaire in favour of the GC group. The groups did not differ in consumption of analgesics or professional condition at any time. No serious intervention-related adverse events occurred. Study limitations included patients lost to the study because of injection-related technical issues in the L5/S1 disc and short time of follow-up.
CONCLUSION


As compared with intradiscal injection of lidocaine, intradiscal injection of prednisolone acetate for low back pain with active discopathy may reduce pain intensity at 1 month but not at 3 and 6 months. Registration: ClinicalTrials.gov: NCT01694134.",2020,"Pain intensity was significantly reduced at 1 month in the GC versus L group (mean [SD] -2.7 [2.3] and +0.1 [2.0], p<0.001) but not at 3 and 6 months.","['50 patients (mean age 50 years; 46% women) with lumbar active discopathy on MRI and failure of medical treatment for more than 6 weeks', 'chronic low back pain with active discopathy', 'patients with low back pain and active discopathy (Modic 1 changes', '2 tertiary care centers with spine units']","['intradiscal injection of glucocorticoids', 'glucocorticoids versus lidocaine', 'prednisolone acetate [GC', 'corticosteroids', 'lidocaine', 'lidocaine, intradiscal injection of prednisolone acetate', 'Intradiscal glucocorticoids injection']","['low back pain in the previous 8 days (10-point visual analog scale), Dallas Pain Questionnaire, Oswestry Disability Index, analgesic treatment and work status at 1, 3 and 6 months as well as pain', 'pain intensity', 'Pain intensity', 'change in pain', 'daily activities of the Dallas Pain Questionnaire', 'consumption of analgesics or professional condition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",50.0,0.189884,"Pain intensity was significantly reduced at 1 month in the GC versus L group (mean [SD] -2.7 [2.3] and +0.1 [2.0], p<0.001) but not at 3 and 6 months.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Tavares', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Département de Rhumatologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cyteval', 'Affiliation': 'Département de Radiologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Unité de Recherche Clinique et Epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Manna', 'Affiliation': 'Unité de Recherche Clinique et Epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Macioce', 'Affiliation': 'Unité de Recherche Clinique et Epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France; Euromov, Montpellier University, Montpellier, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Thouvenin', 'Affiliation': 'Département de Radiologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Viala', 'Affiliation': 'Service de Radiologie, CHU Nîmes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Lharbi', 'Affiliation': 'Service de Radiologie, CHU Nîmes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gélis', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Euromov, Montpellier University, Montpellier, France; Service de Médecine Physique et de Réadaptation, CHU Nimes, Univ Montpellier, Nimes, France. Electronic address: arnaud.dupeyron@umontpellier.fr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.003']
2534,32461138,HIGH-DOSE VITAMIN D DOES NOT PREVENT POSTOPERATIVE RECURRENCE OF CROHN'S DISEASE IN A RANDOMIZED PLACEBO-CONTROLLED TRIAL.,"BACKGROUND & AIMS


Vitamin D deficiency is common in Crohn's disease (CD). High-dose vitamin D had anti-inflammatory effects in preclinical studies and trials of patients with CD. We performed a randomized trial to determine whether high-dose vitamin D prevents postoperative recurrence of CD after ileocolonic resection.
METHODS


Patients with CD following ileocolonic resection with ileocolonic anastomosis were randomly assigned to groups given weekly 25,000 IU oral vitamin D (n=72) or placebo (n=71) for 26 weeks, at 17 hospitals in the Netherlands and Belgium from February 2014 through June 2017. Patients were assessed at baseline and week 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary endpoint was endoscopic recurrence (modified Rutgeerts score ≥i2b, assessed by blinded readers) at 26 weeks. Secondary endpoints included clinical recurrence (Crohn's disease activity index ≥ 220), quality of life (measured by SF-36, IBD-Q and EQ-5D) and outcomes associated with baseline serum concentration of vitamin D.
RESULTS


In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from median 42 nmol/L at baseline to 81 nmol/L at week 26 (P<0.00001), whereas levels did not change significantly in the placebo group and remained unchanged at 43 nmol/L. In the intention-to-treat analysis, the the proportion of patients with endoscopic recurrence at 26 weeks did not differ significantly between the vitamin D vs the placebo group (58% vs 66%; P=.37). The cumulative rate of clinical recurrence did not differ significantly between the groups (18.1% in the vitamin D group vs 18.3% in the placebo group; P=.91). Quality of life improved slightly over time in both groups but did not differ significantly between groups (P=.07). There were few adverse events in either group.
CONCLUSIONS


High-dose vitamin D, compared with placebo, did not reduce the incidence of postoperative endoscopic or clinical recurrence of CD in patients who underwent ileocolonic resection with ileocolonic anastomosis. ClinicalTrials.gov no: NCT02010762.",2020,Quality of life improved slightly over time in both groups but did not differ significantly between groups (P=.07).,"['patients who underwent ileocolonic resection with ileocolonic anastomosis', 'n=71) for 26 weeks, at 17 hospitals in the Netherlands and Belgium from February 2014 through June 2017', ""Crohn's disease (CD"", 'patients with CD', 'Patients with CD following ileocolonic resection with ileocolonic anastomosis']","['High-dose vitamin D', 'ileocolonoscopy', 'oral vitamin D', 'vitamin D', 'placebo']","[""clinical recurrence (Crohn's disease activity index ≥ 220), quality of life (measured by SF-36, IBD-Q and EQ-5D) and outcomes associated with baseline serum concentration of vitamin D"", 'endoscopic recurrence', 'proportion of patients with endoscopic recurrence', 'incidence of postoperative endoscopic or clinical recurrence of CD', 'Quality of life', 'postoperative recurrence of CD', 'cumulative rate of clinical recurrence', 'serum levels of 25-hydroxy vitamin D']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0740369', 'cui_str': 'Ileocolonic anastomosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.751718,Quality of life improved slightly over time in both groups but did not differ significantly between groups (P=.07).,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'de Bruyn', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Gastroenterology and Hepatology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'West', 'Affiliation': 'Department of Gastroenterology and Hepatology, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Witteman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Wildenberg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoentjen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Franchimont', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Esmé', 'Initials': 'E', 'LastName': 'Clasquin', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jarmila D', 'Initials': 'JD', 'LastName': 'van der Bilt', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Almere, the Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Department of General and Abdominal Surgery, Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': ""D'Hoore"", 'Affiliation': 'Department of Abdominal Surgery, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Duijvestein', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Inflammatory Bowel Disease Center and Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: g.dhaens@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.037']
2535,32461289,Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial.,"INTRODUCTION


Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN.
METHODS AND ANALYSIS


This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
ETHICS AND DISSEMINATION


This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles.
TRIAL REGISTRATION NUMBER


NCT03822338.",2020,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
","['Eligible participants will be patients with renal tumours and willing to choose elective LPN', 'renal function after laparoscopic partial nephrectomy']","['laparoscopic partial nephrectomy (LPN', 'Pneumoperitoneum preconditioning (PP', 'Pneumoperitoneum preconditioning']","['renal function', 'serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months', 'glomerular filtration rate and the level of serum cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",,0.715931,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Luwei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Liuhua', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Nuclear Medicine Center, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Gaojian', 'Initials': 'G', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Tianli', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Ruipeng', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China urojiarp@njmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-032002']
2536,32461297,Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study.,"INTRODUCTION


Adalimumab is effective for maintenance of remission in patients with Crohn's disease (CD) at a dose of 40 mg subcutaneously every 2 weeks. However, adalimumab is associated with (long-term) adverse events and is costly. The aim of this study is to demonstrate non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening compared to standard dosing of every other week (EOW).
METHODS AND ANALYSIS


The Lengthening Adalimumab Dosing Interval (LADI) study is a pragmatic, multicentre, open label, randomised controlled non-inferiority trial. Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%. 174 CD patients on adalimumab maintenance therapy in long-term (>9 months) clinical and biochemical remission will be included (C-reactive protein (CRP) <10 mg/L, faecal calprotectin (FC) <150 µg/g, Harvey-Bradshaw Index (HBI) <5). Patients will be randomised 2:1 into the intervention (adalimumab interval lengthening) or control group (adalimumab EOW). The intervention group will lengthen the adalimumab administration interval to every 3 weeks, and after 24 weeks to every 4 weeks. Clinical and biochemical disease activity will be monitored every 12 weeks by physician global assessment, HBI, CRP and FC. In case of disease flare, dosing will be increased. A flare is defined as two of three of the following criteria; FC>250 µg/g, CRP≥10 mg/l, HBI≥5. Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.
ETHICS AND DISSEMINATION


The study is approved by the Medical Ethics Committee Arnhem-Nijmegen, the Netherlands (registration number NL58948.091.16). Results will be published in peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBERS


EudraCT registry (2016-003321-42); Clinicaltrials.gov registry (NCT03172377); Dutch trial registry (NTRID6417).",2020,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"['174\u2009CD patients on', ""quiescent Crohn's disease patients"", ""patients with Crohn's disease (CD""]","['CRP≥10 mg/l, HBI≥5', 'adalimumab', 'intervention (adalimumab interval lengthening) or control group (adalimumab EOW', 'Adalimumab', 'adalimumab interval lengthening', 'adalimumab maintenance therapy', 'Lengthening adalimumab']","['cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.22005,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"[{'ForeName': 'L J T', 'Initials': 'LJT', 'LastName': 'Smits', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'R W M', 'Initials': 'RWM', 'LastName': 'Pauwels', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'de Vries', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hoentjen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'van der Woude', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands c.vanderwoude@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035326']
2537,32461298,Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance.,"INTRODUCTION


Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for standard radical treatment with cystectomy or daily radiotherapy present a large unmet clinical need. Untreated, they suffer high cancer specific mortality and risk significant disease-related local symptoms. Hypofractionated radiotherapy (delivering higher doses in fewer fractions/visits) is a potential treatment solution but could be compromised by the mobile nature of the bladder, resulting in target misses in a significant proportion of fractions. Adaptive 'plan of the day' image-guided radiotherapy delivery may improve the precision and accuracy of treatment. We aim to demonstrate within a randomised multicentre phase II trial feasibility of plan of the day hypofractionated bladder radiotherapy delivery with acceptable rates of toxicity.
METHODS AND ANALYSIS


Patients with T2-T4aN0M0 MIBC receiving 36 Gy in 6-weekly fractions are randomised (1:1) between treatment delivered using a single-standard plan or adaptive radiotherapy using a library of three plans (small, medium and large). A cone beam CT taken prior to each treatment is used to visualise the anatomy and select the most appropriate plan depending on the bladder shape and size. A comprehensive radiotherapy quality assurance programme has been instituted to ensure standardisation of radiotherapy planning and delivery. The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2). Secondary endpoints include local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning. Target recruitment is 62 patients.
ETHICS AND DISSEMINATION


The trial is approved by the London-Surrey Borders Research Ethics Committee (13/LO/1350). The results will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities.
TRIAL REGISTRATION NUMBER


NCT01810757.",2020,"The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","['Patients with T2-T4aN0M0 MIBC receiving 36\u2009Gy in 6-weekly fractions', 'Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for', '62 patients']","['adaptive radiotherapy', 'standard radical treatment with cystectomy or daily radiotherapy', 'radiotherapy planning and delivery guidance', 'single-standard plan or adaptive radiotherapy', 'plan of the day hypofractionated bladder radiotherapy', 'hypofractionated adaptive radiotherapy', 'Hypofractionated radiotherapy']","['exclude  > 30% acute grade  > 3 non-genitourinary toxicity', 'local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454111', 'cui_str': 'Radiotherapy planning'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0852246', 'cui_str': 'Bladder radiotherapies'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0277565', 'cui_str': 'Local disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",,0.169588,"The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","[{'ForeName': 'Shaista', 'Initials': 'S', 'LastName': 'Hafeez', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK shaista.hafeez@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Patel', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Karole', 'Initials': 'K', 'LastName': 'Warren-Oseni', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Hansen', 'Affiliation': 'Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McNair', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037134']
2538,32461420,A prospective study to assess the role of vitamin D individually and in combination with cyclosporine in the treatment of dry eye in patients with deficient serum 25(OH)D levels.,"Purpose


To study the efficiency of vitamin D3 (buccal spray) alone and combination of vitamin D3 with cyclosporine in the treatment of dry eye disease (DED) in patients with deficient serum 25(OH)D levels.
Methods


Around 90 patients with DED with deficient serum 25(OH)D levels were included and randomized into three groups and were given treatment for dry eye (Group A- 0.5% carboxymethylcellulose (CMC), Group B- 0.5% CMC + 2000 IU vitamin D through buccal spray, Group C- 0.5% CMC + 2000 IU vitamin D through buccal spray + 0.05% cyclosporine). The patients were followed at day-15, day-30, and day-90 for improvement in tear breakup time (TBUT) and Schirmer's, and ocular surface disease index (OSDI) score. Improvement in serum vitamin D level was assessed at day-90. One way ANOVA test, paired t-test, and Chi-square test were used for analysis.
Results


Group B and Group C had significantly higher in Schirmer's test-I values as compared to Group A (P = 0.001, P < 0.001, P < 0.001 at day-15, day-30, and day-90, respectively). Significantly higher values of TBUT and mean serum vitamin D levels were obtained in Group B and Group C as compared to Group A at day-90 (P < 0.05). OSDI scores of patients significantly decreased in all three groups at all follow-up visits (P < 0.05). Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
Conclusion


Vitamin D supplementation leads to earlier and significant improvement in TBUT, Schirmer's, and OSDI score in patients with vitamin D deficient DED.",2020,"Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
","['90 patients with DED with deficient serum 25(OH)D levels', 'patients with deficient serum 25(OH)D levels', 'patients with vitamin D deficient DED']","['Vitamin D supplementation', 'vitamin D3 (buccal spray) alone and combination of vitamin D3 with cyclosporine', 'vitamin D', 'cyclosporine', 'dry eye (Group A- 0.5% carboxymethylcellulose (CMC), Group B- 0.5% CMC + 2000 IU vitamin D through buccal spray, Group C- 0.5% CMC + 2000 IU vitamin D through buccal spray + 0.05% cyclosporine']","['TBUT and mean serum vitamin D levels', ""TBUT, Schirmer's, and OSDI score"", ""Schirmer's test"", 'OSDI scores', 'serum vitamin D level', ""tear breakup time (TBUT) and Schirmer's, and ocular surface disease index (OSDI) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4706608', 'cui_str': 'Conventional release buccal spray'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0180163,"Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
","[{'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Watts', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Sahai', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'P Ratan', 'Initials': 'PR', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Mohd Abid', 'Initials': 'MA', 'LastName': 'Shamshad', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Gopal Krishan', 'Initials': 'GK', 'LastName': 'Trivedi', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Lokendra', 'Initials': 'L', 'LastName': 'Tyagi', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1492_19']
2539,32461441,Comparative study of pars plana vitrectomy with or without intravitreal dexamethasone implant for idiopathic epiretinal membrane.,"Purpose


To investigate if use of adjunctive intravitreal dexamethasone implant during pars plana vitrectomy (PPV) leads to faster visual recovery and reduction of retinal thickness in idiopathic epiretinal membrane (ERM).
Methods


In this non-randomized, comparative, interventional study 30 eyes (from 30 patients with idiopathic ERM) were enrolled. In the control group (n = 15), patients underwent 25-G pars plana vitrectomy (PPV) and ERM peeling. In the study group (n = 15), each patient underwent the same procedure as those in the control group, and also received an additional dexamethasone implant. Primary outcome after treatment was mean gain in best corrected visual acuity (BCVA), and secondary outcome was reduction in central retinal thickness (CRT). Data were analyzed using Fisher's exact test, Wilcoxon rank sum test, and two-sample t-test.
Results


The mean gain in BCVA (logMAR) from baseline at 1-month follow-up was significantly higher in the study group (median = -0.3, IQR = -0.4, -0.1) than in the control group (median = 0, IQR = -0.1, 0.3; P < 0.008). However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55). At 1-month follow-up, one and seven patients in the control and study groups gained ≥15 letters of BCVA (P < 0.05), respectively. The mean reductions in CRT at the 1-month follow-up were significantly higher in the study group than in the control group (Mean = -60 μm, SD = 92.1; P < 0.014; 95% CI = 19.75-156.54). The difference in mean reduction of CRT at 6 months was not significant (P < 0.24).
Conclusion


Adjunctive dexamethasone implant can aid faster visual recovery after PPV in idiopathic ERM, although the implants do not affect long-term gains in visual acuity.",2020,"However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55).","['idiopathic epiretinal membrane (ERM', '30 eyes (from 30 patients with idiopathic ERM', 'idiopathic epiretinal membrane']","['dexamethasone implant', 'adjunctive intravitreal dexamethasone implant during pars plana vitrectomy (PPV', 'pars plana vitrectomy with or without intravitreal dexamethasone implant', '25-G pars plana vitrectomy (PPV) and ERM peeling']","['mean reduction of CRT', 'mean gain in BCVA (logMAR', 'mean reductions in CRT', 'mean gain in best corrected visual acuity (BCVA), and secondary outcome was reduction in central retinal thickness (CRT', 'mean gain in BCVA', 'visual recovery']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",30.0,0.0449722,"However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55).","[{'ForeName': 'Surabhi S', 'Initials': 'SS', 'LastName': 'Sane', 'Affiliation': 'Kanuri Santhamma Vitreo-Retina Service, L. V. Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Mohammad Hasnat', 'Initials': 'MH', 'LastName': 'Ali', 'Affiliation': 'Department of Biostatistics; Suven Clinical Research Center, Hyderabad Eye Research Foundation, L.V. Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Baruch D', 'Initials': 'BD', 'LastName': 'Kuppermann', 'Affiliation': 'Gavin Herbert Eye Institute, University of California, Irvine, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Narayanan', 'Affiliation': 'Kanuri Santhamma Vitreo-Retina Service; Suven Clinical Research Center, Hyderabad Eye Research Foundation, L.V. Prasad Eye Institute, Hyderabad, Telangana, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1045_19']
2540,32461510,The evaluation of the desensitization effect of a desensitizing agent and desensitizing toothpastes in vitro.,"This study was evaluating how three desensitizing toothpastes used at home influence the effect associated with desensitizing agents after application in the clinic. Fifty dentine disks measure it permeability and 32 dentine disks with similar permeability levels were selected. Following Dental desensitizer treatment, dentine disks were randomly divided into three subgroups (n=10) that received applications of three toothpastes, respectively. The permeability (Lp) of each specimen was measured after each treatment. One specimen was selected from each group for scanning electron microscopy (SEM) observation. After each treatment, the Lp values decreased significantly for each group (p<0.05) and either completely or partially blocked the dentine tubules upon SEM observation. However, no significant differences in Lp values were observed amongst subgroups (p>0.05). After using the Dental desensitizer, Sensodyne, Crest and Colgate desensitizing toothpastes both can continued to reduce the permeability of the dentine disk, and no significant differences were found amongst them.",2020,"After each treatment, the Lp values decreased significantly for each group (p<0.05) and either completely or partially blocked the dentine tubules upon SEM observation.",[],['desensitizing agent and desensitizing toothpastes'],"['permeability of the dentine disk', 'permeability (Lp) of each specimen', 'Lp values']",[],"[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0171731,"After each treatment, the Lp values decreased significantly for each group (p<0.05) and either completely or partially blocked the dentine tubules upon SEM observation.","[{'ForeName': 'Meng-Long', 'Initials': 'ML', 'LastName': 'Hu', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}, {'ForeName': 'Ruo-Dan', 'Initials': 'RD', 'LastName': 'Jiang', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Han', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}, {'ForeName': 'You-Dong', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Dental Medical Devices Testing Center, Dental Materials Laboratory, Peking University School and Hospital of Stomatology.'}]",Dental materials journal,['10.4012/dmj.2019-164']
2541,32461540,Recovery From Exhaustion of the Frank-Starling Mechanism by Mechanical Unloading With a Continuous-Flow Ventricular Assist Device.,"BACKGROUND


We describe our original left ventricular assist device (LVAD) speed ramp and volume loading test designed to evaluate native heart function under continuous-flow LVAD support.Methods and Results:LVAD speed was decreased in 4 stages from the patient's optimal speed to the minimum setting for each device. Under minimal LVAD support, patients were subjected to saline loading (body weight [kg]×10 mL in 15 min). Echocardiographic and hemodynamic data were obtained at each stage of the LVAD speed ramp and every 3 min during saline loading. Patients were divided into Recovery (with successful LVAD removal; n=8) and Non-recovery (others; n=31) groups. During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173). Increased cardiac output from volume loading was significantly higher in the Recovery than Non-recovery group (group effect, P=0.0124; time effect, P<0.0001; interaction effect, P=0.0091). Therefore, the Frank-Starling curve of the Recovery group was located upward and to the left of that of the Non-recovery group.
CONCLUSIONS


The LVAD speed ramp and volume loading test facilitates the precise evaluation of native heart function during continuous-flow LVAD support.",2020,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).",[],['saline loading (body weight'],"['Frank-Starling curve', 'Increased cardiac output from volume loading', 'pulmonary capillary wedge pressure', 'Echocardiographic and hemodynamic data']",[],"[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0326711', 'cui_str': 'Sturnus vulgaris'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0416434,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Surgery, Fukui Cardiovascular Center.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Sera', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Daimon', 'Affiliation': 'Department of Biostatistics, Hyogo College of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0070']
2542,32461554,Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial.,"OBJECTIVE


Recent clinical trials have demonstrated that colchicine may have metabolic and cardiovascular and benefits in at-risk patients; however, the mechanisms through which colchicine may improve outcomes are still unclear. We sought to examine colchicine's effects on circulating inflammatory and metabolic molecules in adults with obesity and metabolic syndrome (MetS).
METHODS


Blood samples were collected pre- and post-intervention during a double-blind randomized controlled trial in which 40 adults with obesity and MetS were randomized to colchicine 0.6 mg or placebo twice-daily for 3 months. Serum samples were analyzed for 1305 circulating factors using the SomaScan Platform. The Benjamini-Hochberg procedure was used to adjust the false discovery rate (FDR) for multiple testing.
RESULTS


At baseline, age (48.0 ± 13.8 vs. 44.7 ± 10.3 years) and BMI (39.8 ± 6.4 vs. 41.8 ± 8.2 kg/m 2 ) were not different between groups. After controlling for the FDR, 34 molecules were significantly changed by colchicine. Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A). Conversely, relative to placebo, colchicine significantly increased concentrations of eight molecules including secreted factors associated with metabolism and anti-thrombosis.
CONCLUSIONS


In adults with obesity, colchicine significantly affected concentrations of proteins involved in the innate immune system, endothelial function and atherosclerosis, uncovering new mechanisms behind its cardiometabolic effects. Further research is warranted to investigate whether colchicine's IL-6 suppressive effects may be beneficial in COVID-19.",2020,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","['adults with obesity and metabolic syndrome', '40 adults with obesity and MetS', 'adults with obesity and metabolic syndrome (MetS', 'At baseline, age (48.0\u2009±\u200913.8 vs. 44.7\u2009±\u200910.3 years) and BMI (39.8\u2009±\u20096.4 vs. 41.8\u2009±\u20098.2\u2009kg/m 2 ']","['placebo, colchicine', 'Colchicine', 'colchicine', ""Colchicine's"", 'colchicine 0.6\u2009mg or placebo']","['concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin', 'metabolic and inflammatory molecules', 'circulating inflammatory and metabolic molecules', 'false discovery rate (FDR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0985108', 'cui_str': 'Colchicine 0.6 MG'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",40.0,0.602228,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA. ademido1@jh.edu.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Apps', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Foo K', 'Initials': 'FK', 'LastName': 'Cheung', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Fantoni', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tushar P', 'Initials': 'TP', 'LastName': 'Patel', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0598-3']
2543,32461568,The Arclight vs. traditional ophthalmoscope: a cross-over trial.,"BACKGROUND/OBJECTIVES


To compare skill acquisition of the new, cost-effective Arclight ophthalmoscope, with the traditional ophthalmoscope (TO), in medical students with no prior experience of ophthalmoscopy.
SUBJECTS/METHODS


University of Dundee medical students took part in a cross-over trial. Students were divided into two groups and were alternately taught each device using a video tutorial. In period one, Group A was taught the TO first; Group B was taught the Arclight. They were then assessed using simulated objective, structured, clinical, examinations, examining four model heads with lettered fundal photographs of varying sizes of font. Groups crossed over following a 2-week washout period and were taught the second device and reassessed. A questionnaire was distributed to ascertain students' opinions and preferences.
RESULTS


Forty medical students participated. Overall, 92.5% of students performed better with the Arclight, irrespective of cross-over trial period. The mean difference in score in period one of the cross-over trial was 16.77 (95% CI: 11.63-21.93), with students performing better with the Arclight (p < 0.0001). The mean difference in score in period two was 8.02 (95% CI: 4.52-11.52), with students performing better with the Arclight (p < 0.0001). In addition, performance with the TO improved by 52.9% following initial exposure to the Arclight. The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
CONCLUSION


Students performed better with and preferred the Arclight ophthalmoscope. The Arclight could be considered as a suitable alternative to the TO used for training medical students.",2020,"The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
","['Forty medical students participated', 'medical students with no prior experience of ophthalmoscopy', 'University of Dundee medical students took part in a cross-over trial']",['traditional ophthalmoscope (TO'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0029090', 'cui_str': 'Ophthalmoscopy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0182046', 'cui_str': 'Ophthalmoscope'}]",[],,0.0218472,"The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
","[{'ForeName': 'Monica Lorraina', 'Initials': 'ML', 'LastName': 'Hytiris', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK. monica.hytiris@nhs.net.'}, {'ForeName': 'Evridiki', 'Initials': 'E', 'LastName': 'Fioratou', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Stewart N', 'Initials': 'SN', 'LastName': 'Gillan', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}]","Eye (London, England)",['10.1038/s41433-020-0972-3']
2544,32461626,Timing of milk expression following delivery in mothers delivering preterm very low birth weight infants: a randomized trial.,"OBJECTIVE


To determine the effect of timing of expression initiation on mother's own milk production and time to secretory activation in mothers of preterm infants.
STUDY DESIGN


180 mothers delivering infants ≤1500 grams and ≤32 weeks gestation were randomized to begin expression within 60 (early), 61-180 (intermediate) or 181-360 (late) minutes following delivery. Milk volume was measured on days 1-7 and weekly for 6 weeks. Time to secretory activation was determined through self-report.
RESULTS


The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045). The late group had more expressions on day 1 (early: p = 0.049; intermediate; p = 0.048).
CONCLUSION


Initiation of expression at 181-360 min following delivery was associated with increased milk production for 6 weeks following delivery. Further research is needed to determine the effect of expression frequency on milk production in the first days following birth.",2020,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"['mothers of preterm infants', 'mothers delivering preterm very low birth weight infants', '180 mothers delivering infants', '≤1500 grams and ≤32 weeks gestation']",[],"['milk production', 'Milk volume', 'Time to secretory activation']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0558187', 'cui_str': 'Lactation established'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",180.0,0.11443,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'University of Florida, Gainesville, FL, USA. Parkela@ufl.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Kruger', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0688-z']
2545,32461709,Built Environment Exposures of Adults in the Moving to Opportunity Experiment.,"This paper describes environmental exposures of adult participants in the Moving to Opportunity for Fair Housing (MTO) experiment over a four to seven year period from baseline to the interim evaluation. The MTO experiment randomized participants living in public housing or private assisted housing at baseline into experimental and control groups and provided a housing voucher for experimental group participants to move to neighborhoods with less than 10 percent of the population below the poverty line. However, few studies have examined how this move affected exposures to health promoting environments. We used data on residential locations of MTO participants and archival data on the built and food environment to construct environmental exposure variables. MTO participants in the experimental and Section 8 groups lived in neighborhoods with higher food prices, less high intensity development and more open space relative to the control group. The findings suggest that housing policies can have potential health consequences by altering health-related environmental exposures.",2020,"MTO participants in the experimental and Section 8 groups lived in neighborhoods with higher food prices, less high intensity development and more open space relative to the control group.","['participants living in public housing or private assisted housing at baseline into experimental and control groups and provided a housing voucher for experimental group participants to move to neighborhoods with less than 10 percent of the population below the poverty line', 'adult participants in the Moving to Opportunity for Fair Housing (MTO) experiment over a four to seven year period from baseline to the interim evaluation']",[],[],"[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299988', 'cui_str': 'MOVED TO'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",[],[],,0.0265041,"MTO participants in the experimental and Section 8 groups lived in neighborhoods with higher food prices, less high intensity development and more open space relative to the control group.","[{'ForeName': 'Cathy L', 'Initials': 'CL', 'LastName': 'Antonakos', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Claudia J', 'Initials': 'CJ', 'LastName': 'Coulton', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University. Cleveland OH.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaestner', 'Affiliation': 'Institute of Government and Public Affairs, University of Illinois, Chicago, Illinois.'}, {'ForeName': 'Mickey', 'Initials': 'M', 'LastName': 'Lauria', 'Affiliation': 'College of Architecture, Arts and Humanities, Clemson University, Clemson, SC.'}, {'ForeName': 'Dwayne E', 'Initials': 'DE', 'LastName': 'Porter', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI.'}]",Housing studies,['10.1080/02673037.2019.1630560']
2546,32461758,Effect of the Aortic Root Infusion of Sufentanil on Ischemia-Reperfusion Injury in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Clinical Trial.,"Background:  Ischemic postconditioning is a novel strategy for attaining cardioprotection. Remarkable evidence from various in vitro and in vivo animal and human studies have shown significant opioid-induced cardioprotection against myocardial ischemia/reperfusion (I/R) injury. The purpose of this study was to assess the cardioprotective effect of sufentanil against I/R injury after on-pump coronary artery bypass grafting (CABG).  Methods:  Between June 2016 and July 2017, 80 consecutive patients with triple-vessel disease undergoing on-pump CABG were enrolled in this prospective randomized study. The patients assigned to the sufentanil group received a single dose of sufentanil (0.2 μg/kg diluted with 50 cc of saline) 5 minutes before the removal of the aorta cross-clamp, with the sufentanil injected via a cardioplegia needle into the aortic root. In the control group, the same volume of normal saline was injected as a placebo. Cardiac enzymes, the inotrope score, and the outcome data were compared between the 2 groups.  Results : The mean age of the patients was 60.48±7.50 years (range=41-69 y), and men comprised 65.0% of the study population. The levels of CK-MB and cardiac troponin I were significantly lower in the sufentanil group (P<0.001). The amount of inotrope use (P<0.001), the incidence of atrial fibrillation (P=0.014), electrical shock (P=0.007), and the mechanical ventilation time (P<0.001) decreased in the sufentanil group compared with the control group. However, the use of intra-aortic balloon pumps (P=0.247) and the ICU length of stay (P=0.867) were not significantly different between the 2 groups.  Conclusion : The injection of a single dose of sufentanil into the aortic root prior to aorta cross-clamp removal diminished cardiac injury during on-pump CABG in our patients.",2019,"However, the use of intra-aortic balloon pumps (P=0.247) and the ICU length of stay (P=0.867) were not significantly different between the 2 groups.  ","['The mean age of the patients was 60.48±7.50 years (range=41-69 y), and men comprised 65.0% of the study population', '80 consecutive patients with triple-vessel disease undergoing on-pump CABG', 'June 2016 and July 2017', 'Patients Undergoing Coronary Artery Bypass Grafting']","['Aortic Root Infusion of Sufentanil', 'sufentanil injected via a cardioplegia needle into the aortic root', 'sufentanil', 'sufentanil (0.2 μg/kg diluted with 50 cc of saline', 'placebo']","['levels of CK-MB and cardiac troponin', 'cardioprotective effect', 'Ischemia-Reperfusion Injury', 'incidence of atrial fibrillation', 'mechanical ventilation time', 'ICU length of stay', 'electrical shock']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0856738', 'cui_str': 'Triple vessel disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}]",80.0,0.139007,"However, the use of intra-aortic balloon pumps (P=0.247) and the ICU length of stay (P=0.867) were not significantly different between the 2 groups.  ","[{'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Khosravi', 'Affiliation': 'Department of Anesthesia, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Kahrom', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Tahari', 'Affiliation': 'Division of Cardiac Perfusion, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Soltani', 'Affiliation': 'Department of Anesthesia, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Ghanad', 'Affiliation': 'Department of Anesthesia, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",The journal of Tehran Heart Center,[]
2547,32461833,"A low caffeine dose improves maximal strength, but not relative muscular endurance in either heavier-or lighter-loads, or perceptions of effort or discomfort at task failure in females.","Background


The body of literature considering caffeine as an ergogenic aid has primarily considered typically aerobic based exercise, male participants and moderate-to large-caffeine doses. With this in mind the aim of this project was to explore the effects of a low-caffeine dose upon maximal voluntary contraction (MVC) and muscular endurance (time to task failure, TTF) at heavier-and lighter-loads.
Methods


Nineteen physically active, habitual caffeine consuming females randomly performed four testing conditions; two with a low-dose of caffeine (100 mg equating to mean = 1.5 ± 0.18 mg·kg -1 ) and two placebo conditions, where they performed a maximal strength test (MVC) knee extension at 45° followed by a task of relative muscular endurance (sustained isometric contraction for TTF) using either heavier-(70% MVC) and lighter-(30% MVC) loads. Each participant performed each load condition following both caffeine and placebo consumption. Immediately following cessation of the muscular endurance test participants were asked to report their rating of perceived effort (RPE) and rating of perceived discomfort (RPD).
Results


Analyses revealed a significant effect for caffeine upon MVC compared to placebo ( p  = 0.007). We also found a significantly greater TTF for the lighter-compared to the heavier-load condition ( p  < 0.0001); however, there was no significant effect comparing caffeine to placebo ( p  = 0.2368), but insufficient precision of estimates to infer equivalence in either lighter-( p  = 0.750) or heavier-load ( p  = 0.262) conditions. There were no statistically significant effects for caffeine compared with placebo, or lighter-compared with heavier-loads, for RPE and RPD (all  p  > 0.05). RPE was statistically equivalent between caffeine and placebo for both lighter-( p  = 0.007) and heavier-load ( p  = 0.002) conditions and RPD for heavier-( p  = 0.006) but not lighter-load ( p  = 0.136).
Discussion


This is the first study to demonstrate a positive effect on strength from a low caffeine dose in female participants. However, it is unclear whether caffeine positively impacts upon relative muscular endurance in either heavier-or lighter-loads. Further, both RPE and RPD appear to be relatively similar during isometric tasks performed to task failure independently of caffeine supplementation or load. These findings may have implications for persons wishing to avoid side-effects or withdrawal symptoms associated with larger caffeine doses whilst still attaining the positive strength responses.",2020,RPE was statistically equivalent between caffeine and placebo for both lighter-( p  = 0.007) and heavier-load ( p  = 0.002) conditions and RPD for heavier-(,"['female participants', 'Methods\n\n\nNineteen physically active, habitual caffeine consuming females']","['caffeine and placebo consumption', 'maximal strength test (MVC) knee extension at 45° followed by a task of relative muscular endurance (sustained isometric contraction for TTF) using either heavier-(70% MVC) and lighter-(30% MVC) loads', 'low-caffeine', 'caffeine', 'caffeine and placebo', 'placebo']","['relative muscular endurance', 'RPE and RPD', 'heavier-load', 'maximal strength', 'maximal voluntary contraction (MVC) and muscular endurance (time to task failure, TTF', 'rating of perceived effort (RPE) and rating of perceived discomfort (RPD', 'RPE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",19.0,0.0968049,RPE was statistically equivalent between caffeine and placebo for both lighter-( p  = 0.007) and heavier-load ( p  = 0.002) conditions and RPD for heavier-(,"[{'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Waller', 'Affiliation': 'School of Sport Health and Social Sciences, Solent University, Southampton, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Dolby', 'Affiliation': 'School of Sport Health and Social Sciences, Solent University, Southampton, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'School of Sport Health and Social Sciences, Solent University, Southampton, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'School of Sport Health and Social Sciences, Solent University, Southampton, United Kingdom.'}]",PeerJ,['10.7717/peerj.9144']
2548,32461878,Mapping non-response in a prevention program for cardiometabolic diseases in primary care: How to improve participation?,"Non-response in prevention programs for cardiometabolic diseases (CMD) in primary care is often overlooked. The aim for this study was to define factors that influence the primary response to a selective CMD prevention program and to determine response-enhancing strategies that influence the willingness to participate. We conducted a non-response analysis within a randomized controlled trial evaluating a selective CMD prevention program, the study was conducted from 2013 to 2018 in Netherlands. A random sample of 5616 patients from 15 general practices were invited to complete a risk score (RS) as initial step of the program. Non-responders received an additional questionnaire. The response on the risk score was 51% (n = 2872). From the 3558 non-response questionnaires sent, 786 (22%) were returned. In a multivariable multilevel regression analysis smoking was independently associated with non-response. Of all reported reasons for non-response 'forgot/no time' accounted for 45%. In total, 73% of the non-responders indicated to reconsider participation when approached differently. A personal approach by the patients' own GP, using advertisements and informative campaigns are potentially the best methods to enhance the response. Although a relatively high proportion did not respond to the invitation for the risk score, the majority of them indicated to be willing to participate if a different invitation strategy would be used. With more time and energy, response rates for CMD prevention programs could possibly increase substantially. A next logical step in this process is to test potential response enhancing strategies in research setting.",2020,"Although a relatively high proportion did not respond to the invitation for the risk score, the majority of them indicated to be willing to participate if a different invitation strategy would be used.","['primary care', '2013 to 2018 in Netherlands', '5616 patients from 15 general practices']",['selective CMD prevention program'],"['reconsider participation', 'risk score']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5616.0,0.0187017,"Although a relatively high proportion did not respond to the invitation for the risk score, the majority of them indicated to be willing to participate if a different invitation strategy would be used.","[{'ForeName': 'Ilse F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Julius Center, University Medical Center Utrecht, P.O. Box 85060, 3508 AB Utrecht, The Netherlands.'}, {'ForeName': 'Marcus M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), The Netherlands.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'Julius Center, University Medical Center Utrecht, P.O. Box 85060, 3508 AB Utrecht, The Netherlands.'}, {'ForeName': 'Daphne M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Julius Center, University Medical Center Utrecht, P.O. Box 85060, 3508 AB Utrecht, The Netherlands.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Drijkoningen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), The Netherlands.'}, {'ForeName': 'Roderik A', 'Initials': 'RA', 'LastName': 'Kraaijenhagen', 'Affiliation': 'NDDO Institute for Prevention and Early Diagnostics (NIPED), Amsterdam, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Julius Center, University Medical Center Utrecht, P.O. Box 85060, 3508 AB Utrecht, The Netherlands.'}, {'ForeName': 'François G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), The Netherlands.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101092']
2549,31352906,Association of plasma retinol levels with incident cancer risk in Chinese hypertensive adults: a nested case-control study.,"We aimed to investigate the association between plasma retinol and incident cancer among Chinese hypertensive adults. We conducted a nested case-control study, including 231 patients with incident cancer and 231 matched controls during a median 4·5-year follow-up of the China Stroke Primary Prevention Trial. There was a significant, inverse association between retinol levels and digestive system cancer (per 10 μg/dl increases: OR 0·79; 95 % CI 0·69, 0·91). When compared with participants in the first quartile of retinol (< 52·3 μg/dl), a significantly lower cancer risk was found in participants in quartile 2-4 ( ≥ 52·3 μg/dl: OR 0·31; 95 % CI 0·13, 0·71). However, there was a U-shaped association between retinol levels and non-digestive system cancers where the risk of cancers decreased (although not significantly) with each increment of plasma retinol (per 10 μg/dl increases: OR 0·89; 95 % CI 0·60, 1·31) in participants with retinol < 68·2 μg/dl, and then increased significantly with retinol (per 10 μg/dl increase: OR 1·65; 95 % CI 1·12, 2·44) in participants with retinol ≥ 68·2 μg/dl. In conclusion, there was a significant inverse dose-response association between plasma retinol and the risk of digestive system cancers. However, a U-shaped association was observed between plasma retinol and the risk of non-digestive cancers (with a turning point approximately 68·2 μg/dl).",2019,"There was a significant, inverse association between retinol levels and digestive system cancer (per 10 μg/dl increases: OR 0·79; 95 % CI 0·69, 0·91).","['participants with retinol ≥', '231 patients with incident cancer and 231 matched controls during a median 4·5-year follow-up of the China Stroke Primary Prevention Trial', 'Chinese hypertensive adults']",[],"['plasma retinol levels', 'retinol levels and digestive system cancer', 'plasma retinol and the risk of non-digestive cancers', 'plasma retinol', 'cancer risk']","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0751075', 'cui_str': 'Malignant neoplasm of digestive system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",231.0,0.0877035,"There was a significant, inverse association between retinol levels and digestive system cancer (per 10 μg/dl increases: OR 0·79; 95 % CI 0·69, 0·91).","[{'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""National Clinical Research Center for Kidney Disease, The State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, People's Republic of China.""}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': ""Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, People's Republic of China.""}, {'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, People's Republic of China.""}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Institute of Biomedicine, Anhui Medical University, Hefei 230032, People's Republic of China.""}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': ""Institute of Biomedicine, Anhui Medical University, Hefei 230032, People's Republic of China.""}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Shenzhen Evergreen Medical Institute, Shenzhen 518057, People's Republic of China.""}, {'ForeName': 'Weitong', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Nanning Maternal and Child Health Care Hospital, Nanning 530011, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""School of Public Health (Shenzhen), Sun Yat-Sen University, Guangzhou 510006, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ""Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Peking University First Hospital, Beijing 100034, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Peking University First Hospital, Beijing 100034, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': ""Department of Cardiology, Peking University First Hospital, Beijing 100034, People's Republic of China.""}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, People's Republic of China.""}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': ""National Clinical Research Center for Kidney Disease, The State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, People's Republic of China.""}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""National Clinical Research Center for Kidney Disease, The State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, People's Republic of China.""}]",The British journal of nutrition,['10.1017/S000711451900120X']
2550,31774002,Transcutaneous electrical nerve stimulation of acupuncture points enhances therapeutic effects of oral lactulose solution on opioid-induced constipation.,,2019,,[],"['acupuncture', 'oral lactulose solution']",['opioid-induced constipation'],[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1252332', 'cui_str': 'Lactulose Oral Solution'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.0154203,,"[{'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of the Chinese Academy of Science, Hangzhou, China.'}, {'ForeName': 'Qinfei', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of the Chinese Academy of Science, Hangzhou, China.'}, {'ForeName': 'Guanai', 'Initials': 'G', 'LastName': 'Bao', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of the Chinese Academy of Science, Hangzhou, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of the Chinese Academy of Science, Hangzhou, China.'}, {'ForeName': 'Li-Yan', 'Initials': 'LY', 'LastName': 'Gong', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of the Chinese Academy of Science, Hangzhou, China.'}]",The Journal of international medical research,['10.1177/0300060519874539']
2551,31806881,"OPRM1, OPRK1, and COMT genetic polymorphisms associated with opioid effects on experimental pain: a randomized, double-blind, placebo-controlled study.","Genetic polymorphisms have been shown to affect opioid requirement for pain relief. However, true genetic effect is often difficult to assess due to underlying pain conditions and placebo effects. The goal of this study was to understand how common polymorphisms affect opioid effects while controlling for these factors. A randomized, double-blind, placebo-controlled study was implemented to assess how opioid effects are modulated by COMT (rs6269, rs4633, rs4848, rs4680), OPRM1 (A118G), and OPRK1 (rs1051660, rs702764, rs16918875). One hundred and eight healthy subjects underwent experimental pain testing before and after morphine, butorphanol, and placebo (saline). Association analysis was performed between polymorphisms/haplotypes and opioid response, while correcting for race, gender, placebo effects, and multiple comparisons. Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol. The AA genotype of rs4680 or A_T_C_A/ A_T_C_A (rs6269_rs4633_ rs4818_rs4680) diplotype of COMT, combined with the AG genotype of OPRM1 A118G, showed significantly increased pressure pain threshold from butorphanol. Opioid effects on pressure, ischemic, heat pain, and side effects were nominally associated with several SNPs and haplotypes. Effects were often present in one opioid but not the other. This indicates that these polymorphisms affect pain relief from opioids, and that their effects are opioid and pain modality specific.",2020,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,['One hundred and eight healthy subjects'],"['butorphanol', 'morphine, butorphanol, and placebo (saline', 'placebo']","['Pressure pain', 'pressure, ischemic, heat pain, and side effects', 'pressure pain', 'experimental pain']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.58088,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,"[{'ForeName': 'Kwo Wei David', 'Initials': 'KWD', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Redwood City, CA, USA. kwoweiho@stanford.edu.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Wallace', 'Affiliation': 'Department of Molecular Genetics & Microbiology, and UF Genetics Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0131-z']
2552,31815770,"Development of an Alarm Algorithm, With Nanotechnology Multimodal Sensor, to Predict Impending Infusion Failure and Improve Safety of Peripheral Intravenous Catheters in Neonates.","BACKGROUND


Peripheral intravenous catheters connected to an infusion pump are necessary for the delivery of fluids, nutrition, and medications to hospitalized neonates but are not without complications. These adverse events contribute to hospital-acquired patient harm. An artificial intelligence theory called fuzzy logic may allow the use of appropriate variables to predict infusion failure.
PURPOSE


This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
METHODS


An intravenous infusion nanotechnology monitoring system, using predictor variables of pressure, pH, and oxygen saturation used in a fuzzy logic alarm algorithm was developed to alert the nurse to impending peripheral intravenous infusion failure.
FINDINGS


The developed intravenous infusion nanotechnology monitoring system is composed of a peripheral intravenous catheter with nanotechnology multimodal sensor, an intravenous pump, a fuzzy logic algorithm, and alarm. For example, using this system, an elevated in-line pressure, a low pH, and a low venous oxygen level would generate an alarm for possible impending infusion failure.
IMPLICATIONS FOR PRACTICE


With further development, this technology may help nurses predict and prevent adverse outcomes from intravenous infusions. This work shows how nurses can be content experts and innovators of technology that they use to make clinical decisions.
IMPLICATIONS FOR RESEARCH


After regulatory approval, a randomized controlled trial may be performed to investigate whether interventions at the time of an alarm would result in fewer adverse outcomes and improve safety.",2020,"This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
",['Neonates'],[],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",[],[],,0.0554223,"This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
","[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Bosque', 'Affiliation': ""Neonatology Regional Program, Seattle Children's Hospital, Seattle, Washington.""}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000690']
2553,31822479,Advance care planning and longer survival in the terminally ill: a randomised controlled trial unexpected finding.,,2020,,[],['Advance care planning'],[],[],"[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],,0.216717,,"[{'ForeName': 'Mette Asbjoern', 'Initials': 'MA', 'LastName': 'Neergaard', 'Affiliation': 'Palliative Care Unit, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark mettneer@rm.dk.'}, {'ForeName': 'Marianne Hjorth', 'Initials': 'MH', 'LastName': 'Skorstengaard', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Brogaard', 'Affiliation': 'Research Unit for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Løkke', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Aagaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Andreassen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders Bonde', 'Initials': 'AB', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2019-001906']
2554,31828275,"The Effect of sevoflurane, desflurane and propofol on respiratory mechanics and integrated pulmonary index scores in laparoscopic sleeve gastrectomy. A randomized trial.","OBJECTIVES


To compare the effects of sevoflurane, desflurane, and propofol on respiratory mechanics, and integrated pulmonary index (IPI) scores in patients undergoing laparoscopic sleeve gastrectomy.
METHODS


A total of 60 patients with a body mass index of ≥40 kg/m2, who underwent laparoscopic sleeve gastrectomy between September 2015 and September 2016 at Fatih Sultan Mehmet Health Application and Research Center, Istanbul, Turkey were included in this randomized prospective study. After induction, anesthesia was maintained by sevoflurane in group S, desflurane in group D, and propofol in group P. Peak inspiratory pressure (PIP), plateau pressure (Pplateau), compliance (Cdyn), respiratory resistance (Rrs), and IPI values were recorded. Mann-Whitney U, Kruskal- Wallis, Dunn's, Friedman, and Fisher-Freeman- Halton tests were performed for statistical analysis. A p value of less than 0.05 was considered statistically significant.
RESULTS


A significant increase was found in PIP in group S (T1: 25; T2: 27 cmH2O), and group D (T1: 25; T2: 29,5 cmH2O) during pneumoperitoneum. Dynamic compliance decreased in all groups during pneumoperitoneum. In group S, the decrease in Cdyn was also statistically significant after pneumoperitoneum(T1:43.65;T5:41.25ml/cmH2O). Comparison between groups the values of PIP, Pplateau, Cdyn, Rrs, and IPI were similar.
CONCLUSION


In morbidly obese patients, sevoflurane, desflurane, and propofol are similar in terms of the intraoperative respiratory mechanics, and perioperative respiratory parameters provided with IPI.",2019,A significant increase was found in PIP in group S,"['between September 2015 and September 2016 at Fatih Sultan Mehmet Health Application and\xa0Research Center, Istanbul, Turkey', '60 patients with a body mass index of ≥40 kg/m2, who underwent', 'morbidly obese patients', 'patients undergoing laparoscopic sleeve gastrectomy', 'laparoscopic sleeve gastrectomy']","['sevoflurane, desflurane, and propofol', 'laparoscopic sleeve gastrectomy', 'sevoflurane, desflurane and propofol', 'desflurane', 'sevoflurane', 'propofol']","['respiratory mechanics, and integrated pulmonary index (IPI) scores', 'PIP', 'respiratory mechanics and integrated pulmonary index scores', 'Cdyn', 'Dynamic compliance', 'values of PIP, Pplateau, Cdyn, Rrs, and IPI', 'Peak inspiratory pressure (PIP), plateau pressure (Pplateau), compliance (Cdyn), respiratory resistance (Rrs), and IPI values']","[{'cui': 'C0647895', 'cui_str': 'Sultan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",60.0,0.0276722,A significant increase was found in PIP in group S,"[{'ForeName': 'Mehmet C', 'Initials': 'MC', 'LastName': 'Öztürk', 'Affiliation': 'Intensive Care Unit, Dokuz Eylül University, Izmir, Turkey. E-mail. mhmtcllztrk@hotmail.com.'}, {'ForeName': 'Öznur', 'Initials': 'Ö', 'LastName': 'Demiroluk', 'Affiliation': ''}, {'ForeName': 'Suheyla', 'Initials': 'S', 'LastName': 'Abitagaoglu', 'Affiliation': ''}, {'ForeName': 'Dilek E', 'Initials': 'DE', 'LastName': 'Ari', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2019.12.24693']
2555,31846575,Predicting Remission in Late-Life Major Depression: A Clinical Algorithm Based Upon Past Treatment History.,"OBJECTIVE


To determine the likelihood of antidepressant response in older adults with major depression as a function of their prior antidepressant trials.
METHODS


500 older adults with major depression as diagnosed by DSM-IV criteria for major depressive episode were treated with venlafaxine extended release for 12 weeks. Participants were recruited from July 2009 to January 2014. For each participant, we collected detailed data on prior antidepressant trials for the current episode of depression. We examined the prospective remission rates as a function of number and class of prior antidepressant trials in a post hoc analysis of pooled data from 2 prior trials.
RESULTS


Remission rates with venlafaxine were inversely correlated with the number of prior adequate medication trials (66% for no prior adequate trials, 45% for 1 prior adequate trial, 23% for 2 or more prior adequate trials; P < .0001). Additionally, if prior treatment trials included a serotonin-norepinephrine reuptake inhibitor, participants were even less likely to achieve remission with venlafaxine (32% for 1 prior adequate trial, 18% for 2 or more prior adequate trials; P < .0001). Those with prior adequate trials were also more likely to require a higher dosage of venlafaxine to achieve remission.
CONCLUSIONS


Information on an individual patient's number and class of prior adequate antidepressant trials can be used to predict the likelihood of a successful treatment outcome with a given antidepressant in older adults with major depression. Further work is needed to refine this approach to provide personalized antidepressant treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT00892047 and NCT02263248.",2019,"Those with prior adequate trials were also more likely to require a higher dosage of venlafaxine to achieve remission.
","['500 older adults with major depression as diagnosed by DSM-IV criteria for major depressive episode were treated with', 'Participants were recruited from July 2009 to January 2014', 'Late-Life Major Depression', 'older adults with major depression']",['venlafaxine'],"['Remission rates', 'number of prior adequate medication trials']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",500.0,0.029389,"Those with prior adequate trials were also more likely to require a higher dosage of venlafaxine to achieve remission.
","[{'ForeName': 'Erica L F', 'Initials': 'ELF', 'LastName': 'Buchalter', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Hanadi Ajam', 'Initials': 'HA', 'LastName': 'Oughli', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, CAMH, 250 College St, Toronto, ON, M5T 1R8 Canada. benoit.mulsant@utoronto.ca.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12483']
2556,31329901,CT Fat Density Accurately Reflects Histologic Fat Quality in Adults With HIV On and Off Antiretroviral Therapy.,"CONTEXT


Microscopic measurement of adipocyte size is the gold standard for determining adipose tissue (AT) quality. AT density on CT may also reflect adipocyte quality (lower density = poorer quality).
OBJECTIVE


We used abdominal subcutaneous AT (SAT) specimens and CT scans to validate CT SAT density as a marker of SAT quality in adults living with HIV.
SETTING AND DESIGN


Secondary data analysis from completed trial of antiretroviral therapy (ART) initiation (ACTG A5224s). CT abdominal SAT density was measured in HU. SAT specimens were digitally scanned for calculation of mean adipocyte area.
PARTICIPANTS


Participants had SAT biopsy and CT data at baseline (n = 54) and HIV-1 RNA <50 copies per milliliter on ART and biopsy or CT data at week 96 (n = 30).
OUTCOME MEASURES


Spearman correlations and linear regression models adjusting for participant characteristics examined associations between SAT density and adipocyte area.
RESULTS


Baseline median age was 40 years, CD4+ T lymphocyte count 219 cells per cubic millimeter, and body mass index 26.0 kg/m2; 89% were male and 67% white. Median SAT area and density were 199 cm2 and -100 HU. Over 96 weeks, SAT area increased (+18%) and SAT density decreased (-3%). Mean SAT adipocyte area correlated with SAT density (P < 0.01) off and on ART after adjustment for SAT area, age, race, sex, CD4+ T lymphocyte count, and HIV-1 RNA.
CONCLUSIONS


CT SAT density correlates with biopsy-quantified SAT adipocyte size in adults with HIV on and off ART, suggesting that CT is a useful tool for noninvasive assessment of SAT quality.",2019,"Mean SAT adipocyte area correlated with SAT density (P < 0.01) off and on ART after adjustment for SAT area, age, race, sex, CD4+ T lymphocyte count, and HIV-1 RNA.
","['Adults With HIV On and Off Antiretroviral Therapy', 'adults living with HIV', 'Baseline median age was 40 years, CD4+ T lymphocyte count 219 cells per cubic millimeter, and body mass index 26.0 kg/m2; 89% were male and 67% white', 'Participants had SAT biopsy and CT data at baseline (n = 54) and HIV-1 RNA <50 copies per milliliter on ART and biopsy or CT data at week 96 (n = 30']","['abdominal subcutaneous AT (SAT) specimens and CT scans to validate CT SAT density', 'antiretroviral therapy (ART) initiation (ACTG A5224s']","['adipocyte quality', 'Histologic Fat Quality', 'CT abdominal SAT density', 'Mean SAT adipocyte area correlated with SAT density', 'Median SAT area and density', 'CT Fat Density', 'SAT density', 'SAT area']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1300557', 'cui_str': '/mm3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C1531853', 'cui_str': 'cpy/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1318970', 'cui_str': 'AIDS Clinical Trial Group'}]","[{'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.123184,"Mean SAT adipocyte area correlated with SAT density (P < 0.01) off and on ART after adjustment for SAT area, age, race, sex, CD4+ T lymphocyte count, and HIV-1 RNA.
","[{'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'University of California, Los Angeles, California.'}, {'ForeName': 'Carlee', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Magyar', 'Affiliation': 'University of California, Los Angeles, California.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nelson', 'Affiliation': 'University of California, Los Angeles, California.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': 'University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02785']
2557,32465830,The Impact of Aspirin Dose on Hemocompatibility-Related Adverse Events during HeartMate 3 Support - An Analysis from the MOMENTUM 3 Trial.,"PURPOSE


Antiplatelet therapy with aspirin (ASA) is mandated with Left Ventricular Assist Devices (LVADs) on the presumption that this therapy modulates Hemocompatibility-related adverse events (HRAEs). The effect of aspirin (ASA) dosing, particularly during support with the HeartMate 3 (HM3) LVAD is unknown.
METHODS


We conducted an exploratory analysis of HM3 supported patients in the MOMENTUM 3 clinical trial. HM3 patients were categorized into 2 groups based on daily ASA dose as Usual-dose (325 mg) or Low-dose (81 mg) with anticoagulation targeted to an INR 2.0-3.0. Exclusion criteria included patients not receiving either ASA 81mg or 325mg dose, those with HRAEs ≤7 days after LVAD implantation, or those receiving >1 antiplatelet agent. The composite primary endpoint was freedom from HRAEs, including non-surgical bleeding, pump thrombosis, stroke and peripheral arterial thromboembolic events at 2 years.
RESULTS


Overall, 321 HM3 patients (Usual-dose n=141; Low-dose n=180) were included. Patients in the Usual-dose group were younger (57±13 vs. 60±12 years, p=0.035) and less often implanted as destination therapy (55% vs. 67%, p=0.029) than those receiving Low-dose. INR at the time of HRAEs was clinically similar between Usual- and Low-dose groups (2.20 [1.66, 3.20] vs. 2.0 [1.50, 2.60], p=0.054 respectively). At 2 years, a similar proportion of patients in the Usual- and Low-dose (43.5% vs 45.3%, p=0.94, Figure 1) groups survived free from HRAEs. There were no differences in survival free from component hemorrhagic (Usual-dose: 54.4% vs Low-dose: 51.7%, p=0.42) and thrombotic (Usual-dose: 76.8% vs Low-dose: 75.7%, p=0.92) events.
CONCLUSION


At 2-years after HM 3 LVAD implant, no difference in HRAEs between Usual- and Low-dose ASA was shown in the MOMENTUM 3 clinical trial. These findings suggest similar efficacy and safety of these two distinct aspirin dose ranges and call into question any meaningful therapeutic effect of this agent in HM 3 treated patients.",2020,"There were no differences in survival free from component hemorrhagic (Usual-dose: 54.4% vs Low-dose: 51.7%, p=0.42) and thrombotic (Usual-dose: 76.8% vs Low-dose: 75.7%, p=0.92) events.
","['321 HM3 patients (Usual-dose n=141; Low-dose n=180) were included', 'HM3 patients']","['ASA', 'aspirin (ASA', 'Aspirin']","['freedom from HRAEs, including non-surgical bleeding, pump thrombosis, stroke and peripheral arterial thromboembolic events at 2 years', 'HRAEs', 'survival free from component hemorrhagic', 'thrombotic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}]",,0.056924,"There were no differences in survival free from component hemorrhagic (Usual-dose: 54.4% vs Low-dose: 51.7%, p=0.42) and thrombotic (Usual-dose: 76.8% vs Low-dose: 75.7%, p=0.92) events.
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Columbo', 'Affiliation': 'Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': 'Medicine, Harvard University, Boston, MA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Medicine, Columbia University Medical Center, Bronx, NY.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'Surgery, University of Colorado, Colorado Springs, CO.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Conners', 'Affiliation': 'Medicine, Harvard University, Boston, MA.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Medicine, MedStar Washington Hospital Center, Washington DC, NY.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Mokadam', 'Affiliation': 'Surgery, Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Cardiothoracic Surgery, Ochsner Medical Center, New Orleans, LA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Abbott Inc., Burlington, MA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott Inc., Burlington, MA.'}, {'ForeName': 'U P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Medicine, Montefiore Medical Center, Bronx, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1221']
2558,32465856,Effect of the Shingles Vaccine in Altering Clinical Shingles after Heart Transplantation.,"PURPOSE


Herpes zoster, otherwise known as shingles, can be a devastating complication after heart transplantation due to persistent and severe herpetic neuralgia. Our heart transplant patients are recommended to have the shingles vaccine prior to heart transplantation, but this is not always achieved. We sought to assess whether the shingles vaccine did indeed prevent clinical shingles development after heart transplantation.
METHODS


Between 2010 and 2018, we assessed 40 heart transplant patients who developed shingles post-transplant. We divided patients into those that received either the Zostavax or Shingrix vaccine at our center before transplant versus those that did not. Endpoints included the severity in terms of general pain level and herpetic neuralgia and the location of the rash.
RESULTS


19 of the 40 patients who developed shingles post-transplant had been vaccinated prior to transplant. Most patients were treated with acyclovir, valacyclovir, or famciclovir. Patients in both groups appear to face a comparable severity of shingles. While patients who received the shingles vaccine developed rashes primarily in the truncal area of the body, patients without the vaccine developed rashes mostly in the truncal area and above the neck.
CONCLUSION


Receiving the shingles vaccine prior to heart transplant does not seem to decrease the clinical development of shingles post-transplant. However, a larger number of patients are needed to confirm these findings.",2020,Receiving the shingles vaccine prior to heart transplant does not seem to decrease the clinical development of shingles post-transplant.,"['19 of the 40 patients who developed shingles post-transplant had been vaccinated prior to transplant', 'Our heart transplant patients', 'Between 2010 and 2018', 'Clinical Shingles after Heart Transplantation', '40 heart transplant patients who developed shingles post-transplant']","['Zostavax or Shingrix vaccine', 'Shingles Vaccine', 'acyclovir, valacyclovir, or famciclovir']",['general pain level and herpetic neuralgia and the location of the rash'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C1720919', 'cui_str': 'Zostavax'}, {'cui': 'C4530100', 'cui_str': 'Shingrix'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0209227', 'cui_str': 'famciclovir'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",40.0,0.0287334,Receiving the shingles vaccine prior to heart transplant does not seem to decrease the clinical development of shingles post-transplant.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kittleson', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chang', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nishihara', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shen', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Velleca', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zakowski', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Czer', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Esmailian', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kobashigawa', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.032']
2559,32465861,Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients without Antiplatelet Therapy.,"PURPOSE


Optimization of antithrombotic therapy, with the goal of minimizing bleeding without adversely affecting thromboembolic (TE) rates, is a major priority of the MCS field. We evaluated the safety and efficacy of managing HeartMate II (HM II) patients without antiplatelet therapy.
METHODS


Prospective, multicenter, randomized, double-blind placebo-controlled trial of aspirin (ASA) 81 mg daily in subjects ≥50 years of age receiving warfarin (INR of 2.0-2.5) after initial HM II implantation. Subjects were placed on study drug once hemodynamic stability was achieved, no later than POD 15. Primary efficacy endpoint was the composite incidence of non-surgical bleeding at 6 months. Primary safety endpoint was the composite incidence of pump thrombosis and stroke 6 months post implant. Descriptive endpoints included hemocompatibility related adverse events at 12 months. The study was stopped due to futility given competing enrollment in another study.
RESULTS


65/72 (31 placebo, 34 ASA) subjects enrolled within 48 hours of HM II implant met criteria for initiation of the study drug. At 6 and 12 months, respectively, 47 and 35 subjects remained on study drug. Study discontinuation was due to death (Placebo: 8.6% vs. ASA: 8.1%), transplant/explant (Placebo: 8.6% vs. ASA: 10.8 %), or withdrawal (Placebo: 34.3% vs. ASA: 32.4%) and was comparable between groups. In an as-treated analysis of the primary endpoints, at 6 months, the rates of nonsurgical bleeding (Placebo: 38 [21.6 - 55.9] %; ASA: 44 [27.4 - 60.8] %) and TE events (Placebo: 12.9 [1.1 - 24.7] %; ASA: 8.8 [0.0 - 18.4] %,) did not differ between groups. At 12 months, more major bleeding events had occurred in the ASA group compared to the placebo group (Placebo: 38.7 [21.6 - 55.9] %; ASA: 64.7 [48.6 - 80.8] %), but stroke rates remained comparable (Placebo: 19.4 [5.4 - 33.3] %; ASA: 20.6 [7.0 - 34.2] %).
CONCLUSION


In the first prospective, randomized double blind placebo-controlled study of an ASA free regimen in patients on durable LVAD support receiving warfarin, we did not observe increased rates of TE events. Our findings are only applicable to the HMII device and significantly limited by an early study stop. However, they provide supportive rationale for the study of antiplatelet free regimen in contemporary LVADs, specifically those with decreased device thrombosis.",2020,Study discontinuation was due to death,"['patients on durable LVAD support receiving', 'subjects ≥50 years of age receiving warfarin (INR of 2.0-2.5) after initial HM II implantation', '65/72 (31 placebo, 34 ASA) subjects enrolled within 48 hours of HM II implant met criteria for initiation of the study drug']","['ASA', 'Placebo', 'withdrawal (Placebo', 'warfarin', 'aspirin (ASA', 'managing HeartMate II (HM II) patients without antiplatelet therapy', 'placebo']","['rates of nonsurgical bleeding', 'hemodynamic stability', 'composite incidence of pump thrombosis and stroke 6 months post implant', 'rates of TE events', 'thromboembolic (TE) rates', 'death', 'composite incidence of non-surgical bleeding', 'major bleeding events', 'safety and efficacy', 'stroke rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.519337,Study discontinuation was due to death,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Jorde', 'Affiliation': 'Cardiology, Montefiore Medical Center / Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Cardiology and Pulmonary/Critical Care Medicine, UNC Healthcare System, Chapel Hill, NC.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Cardiology, New York Presbyterian Hospital and Columbia University, New York, NY.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Cardiovascular Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crandall', 'Affiliation': 'Global Clinical Affairs, Abbott, Burlington, MA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Franke', 'Affiliation': 'Global Clinical Affairs, Abbott, Sylmar, CA.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Adamson', 'Affiliation': 'Cardiovascular and Thoracic Surgery, Sharp Memorial Hospital, San Diego, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1224']
2560,32465880,How Does Double Tunnel Driveline Derivation Technique Contributes to Treatment of Driveline Infection?,"PURPOSE


Driveline infection (DLI) is one of the major complications after durable VAD implantation. Since 2016, we have changed from the standard method to a double-tunnel method for driveline (DL) derivation, in which DL was once led to the upper right abdomen, then passed through the subcutaneous tissue horizontally to the left upper abdomen. This study aimed to verify the therapeutic efficacy of the double tunnel method on DLI.
METHODS


From April 2013 to January 2019, all 120 cases of HeartMate2(HM2) implanted for BTT at our hospital were divided into 2 groups; 38 cases for whom DL exited directly from the upper right abdomen (S group) or 82 cases of the double tunnel method (D group). There was no significant intergroup difference in age (41 vs 46; P = 0.05), male ratio 79% vs 67%, (p = 0.2), or BTB case (16% vs 31%, P = 0.1).
RESULTS


DLI occurred in 12 cases (32%) in the S group and 14 cases (17%) in the D group (P = 0.1). The interval between the HM2 implantation and the first DLI occurrence was not significantly different (585 vs 414 days, P = 0.2). Treatment of the DLI was more conservative in the S group, where surgical DL translocation (DTL) was performed in 1 case (8%) in the S group and 10 cases (71%) in the D group (P &lt;0.01). The DTL resulted in primary cure 1 case of the S group (100%) and 8 cases of the D group (80%). The 2 cases who failed to show primary cure post-DTL underwent pump exchange. The medical therapy and/or local irrigation was selected as the primary treatment of DLI in 8 cases of the S group (67%) and in 4 cases of the D group (29%) As a result, 1 case of the S group and 1 case of the D group showed the primary cure, whereas the remaining 10 cases (83%) continued daily wound care and intravenous antibiotics in hospital.
CONCLUSION


DLI occurred one year or more after durable VAD implantation on average, regardless of the driveline derivation method. The double tunnel method contributed to opening the window for aggressive surgical treatment which more frequently resulted in a primary cure of the DLI than the conservative therapy.",2020,"There was no significant intergroup difference in age (41 vs 46; P = 0.05), male ratio 79% vs 67%, (p = 0.2), or BTB case (16% vs 31%, P = 0.1).
","['From April 2013 to January 2019, all 120 cases of HeartMate2(HM2) implanted for BTT at our hospital were divided into 2 groups; 38 cases for whom DL exited directly from the upper right abdomen (S group) or 82 cases of the double tunnel method (D group']",[],"['surgical DL translocation (DTL', 'daily wound care and intravenous antibiotics in hospital', 'DLI occurrence', 'DLI', 'therapeutic efficacy']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0237307,"There was no significant intergroup difference in age (41 vs 46; P = 0.05), male ratio 79% vs 67%, (p = 0.2), or BTB case (16% vs 31%, P = 0.1).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tadokoro', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Taguchi', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimahara', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kobayashi', 'Affiliation': 'Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Suita, Japan.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.052']
2561,32465891,Early Bleeding is Associated with Increased Length of Stay and Early Death in LVAD Recipients.,"PURPOSE


We sought to examine the effects of early (non-GI) bleeding (EB) on length of stay and early mortality (3-months) in patients receiving the Heartware TM  HVAD TM  system for destination therapy.
METHODS


HVAD patients enrolled in the ENDURANCE and ENDURANCE Supplemental trials (n=604) were eligible. Patients were separated into two groups: those with postoperative bleeding by Intermacs definition, excluding GI bleeding, within 72 hours of implant and those without any bleeding within 72 hours. Length of stay, adverse events and survival were examined out to 3 months.
RESULTS


Comparison of baseline characteristics shows that EBs were older (66.6 vs 63.1 years, p=0.002), had smaller BMI (26.2 vs 28.0 kg/m 2 ) p=0.0012), higher BUN (12.2 vs 10.0 mmol/L, p=0.0004), higher total bilirubin (20.9 vs 17.9 umol/L, p=0.05), and more redo sternotomies (48.3% vs 30.9%, p=0.0013). Intraoperatively, EBs had significantly longer CPB time (115 vs 85.9 min, p<0.0001), more PRBC (4.7 vs 2.4 units, p<0.0001), more FFP (5.2 vs 2.9 units, p<0.0001), more platelets (5.9 vs 3.3 packs, p=0.05) (Table 1). Length of stay for EBs was significantly longer (34.5 vs 23.4 days, p=0.0057) and 3-month survival significantly less (75.3% vs 91.4%, p<0.001) (Figure 1).
CONCLUSION


LVAD patients who experienced EB had more redo sternotomy, longer CPB times, more OR transfusions, longer length of stay and decreased short-term survival compared to those who did not have EB. Prospective study is warranted.",2020,"Length of stay for EBs was significantly longer (34.5 vs 23.4 days, p=0.0057) and 3-month survival significantly less (75.3% vs 91.4%, p<0.001) (Figure 1).
","['HVAD patients enrolled in the ENDURANCE and ENDURANCE Supplemental trials (n=604) were eligible', 'patients receiving the Heartware TM  HVAD TM  system for destination therapy']",[],"['postoperative bleeding by Intermacs definition, excluding GI bleeding', '3-month survival', 'FFP', 'longer CPB time', 'length of stay and early mortality (3-months', 'higher BUN', 'higher total bilirubin', 'redo sternotomy, longer CPB times, more OR transfusions, longer length of stay and decreased short-term survival', 'Length of Stay and Early Death', 'PRBC', 'Length of stay for EBs', 'Length of stay, adverse events and survival', 'redo sternotomies', 'smaller BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",604.0,0.0339263,"Length of stay for EBs was significantly longer (34.5 vs 23.4 days, p=0.0057) and 3-month survival significantly less (75.3% vs 91.4%, p<0.001) (Figure 1).
","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Cardiothoracic Surgery, University of Chicago, Chicago, IL.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Tatooles', 'Affiliation': 'Cardiothoracic Surgery, Rush University, Oak Lawn, IL.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Milano', 'Affiliation': 'Cardiothoracic Surgery, Duke University, Durham, NC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Cardiothoracic Surgery, Washington Universty, St. Louis, MO.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Selzman', 'Affiliation': 'Cardiothoracic Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jacoski', 'Affiliation': 'Medical Affairs, Medtronic, Minneapolis, MN.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Cardiothoracic Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Slaughter', 'Affiliation': 'Cardiothoracic Surgery, University of Louisville, Louisville, KY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1225']
2562,32465897,Benefits of High-Intensity Interval Training in a Young and in an Older De Novo Heart Transplant Recipient- Cases from the HITTS Study.,"PURPOSE


High-intensity interval training (HIT) is an effective method to increase exercise capacity in de novo heart transplant recipients, as shown in the recently published HITTS study (High-intensity Interval Training in de novo Heart Transplant recipients in Scandinavia). We were interested to scrutinize the potential effect of HIT in different age categories. The main effects of HIT in one young and one older medically stable de novo heart transplant recipients are reported.
METHODS


The HITTS study is a randomized controlled study comparing HIT versus moderate intensity continuous training (MICT) in de novo heart transplant recipients (mean 11 weeks after heart transplantation). Eighty-one participants were randomized (1:1) to 9 months of HIT or MICT. The primary endpoint was the change in VO 2peak . Secondary endpoints included: Heart rate response, muscle strength and self-reported physical function measured by the Short-Form-36. One of the youngest and one of the oldest participants with the highest changes in VO 2peak  in the HIT intervention group were selected for this case report.
RESULTS


The youngest male (< 25 years old) increased his VO 2peak  with 15.3 mL/kg/min from baseline to follow-up (from 23.5 to 38.8 mL/kg/min), while the older male (> 55 years old) increased his VO 2peak  with 12.6 mL/kg/min (from 15.6 to 28.3 mL/kg/min). Muscle strength, heart rate response, O 2  pulse and self-reported physical function also increased substantially (Table). The young heart transplant recipient completed 51 exercise sessions whereas the older heart transplant recipient completed 72 sessions.
CONCLUSION


Both the young and the older de novo heart transplant recipient increased their VO 2peak  with at least 4 METS (> 12 mL/kg/min) after a 9-month long HIT intervention. The results show that both young and older individuals can derive substantial benefit from HIT soon after heart transplantation.",2020,"Muscle strength, heart rate response, O 2  pulse and self-reported physical function also increased substantially (Table).","['one young and one older medically stable de novo heart transplant recipients', 'de novo heart transplant recipients (mean 11 weeks after heart transplantation', 'novo Heart Transplant recipients in Scandinavia', 'young heart transplant recipient completed 51 exercise sessions whereas the older heart transplant recipient completed 72 sessions', 'de novo heart transplant recipients']","['HIT versus moderate intensity continuous training (MICT', 'High-intensity interval training (HIT', 'High-Intensity Interval Training', 'HIT or MICT']","['Heart rate response, muscle strength and self-reported physical function measured by the Short-Form-36', 'exercise capacity', 'Muscle strength, heart rate response, O 2  pulse and self-reported physical function also increased substantially (Table', 'change in VO 2peak ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",81.0,0.0220706,"Muscle strength, heart rate response, O 2  pulse and self-reported physical function also increased substantially (Table).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.069']
2563,32465908,Follow-Up Phone Calls are Effective in Increasing Compliance with Screening for De Novo Cancer among Heart Transplant Recipients.,"PURPOSE


We aimed to examine the effectiveness of serial follow-up phone calls as an intervention after clinic visits to enhance compliance with cancer surveillance among heart transplant (HT) patients.
METHODS


41 HT cancer-free patients were randomized to intervention (n=21) vs. control (n=20) groups. Time Series Design was used; the intervention group received 4 calls post clinic visits within 31 days at different point intervals between 7-10 days, addressing the patient's specific needs for cancer screening based on immunotherapy and medical issues. The control group received 1 phone call at the end of the study. Chi-Square Statistics was used to compare screening rates between intervention and control groups.
RESULTS


Mean age was 60.3 years, 78% male, and 24% had prior malignancy. 39% of patients were studied 1-5 years post HT, 20% 5-10 years; 26% 10-14 years; and 15% 15-20 years. Main reasons for non-compliance reported by patients were: ""too busy"", ""family issues"", and ""I forgot"". At the end of the study, 50% of patients were fully compliant with cancer screening recommendations in the intervention group vs. 15% in the control group. This difference was statistically significant: (X 2  (1)= 4.062, p= 0.044) (Fig. 1a). Compliance rates after each phone call are shown in Fig. 1b.
CONCLUSION


A nurse practitioner-led follow-up phone calls program is a feasible and effective strategy to increase compliance with de novo cancer screening among adult heart transplant recipients. Additional studies are needed to validate the usefulness of this approach in this unique patient population.",2020,A nurse practitioner-led follow-up phone calls program is a feasible and effective strategy to increase compliance with de novo cancer screening among adult heart transplant recipients.,"['heart transplant (HT) patients', 'adult heart transplant recipients', '41 HT cancer-free patients', 'Mean age was 60.3 years, 78% male, and 24% had prior malignancy', 'Heart Transplant Recipients']","['serial follow-up phone calls', ""4 calls post clinic visits within 31 days at different point intervals between 7-10 days, addressing the patient's specific needs for cancer screening based on immunotherapy and medical issues""]","['cancer screening recommendations', 'Compliance rates']","[{'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",41.0,0.0201151,A nurse practitioner-led follow-up phone calls program is a feasible and effective strategy to increase compliance with de novo cancer screening among adult heart transplant recipients.,"[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Mabasa', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Kleet', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gaine', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fanek', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Czarnecki', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Farr', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Surgery, Columbia University Medical Center, New York, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.076']
2564,32465939,Tailored Immunosuppression Using CYP3A5 Metaboliser Status in Heart and Lung Transplant Cases - An Indian Study.,"PURPOSE


CYP3A5 enzyme allele status affects metabolism of Calcineurin inhibitors . There is data on influence of Polymorphism in CYP alleles on Tacrolimus levels in Caucasian and Afro - American patients, but little data available for Indian patients METHODS: We studied 93 Heart, lung and Combined Heart plus lung transplant patients from our Hospital with 6 months Followup . The age range was 12 yrs to 72 yrs (70 M, 23 F) .Pattern of expression of 2 alleles CYP3A 5 *1 and * 3 were analysed to classify the patients in Two groups - Group A Poor metabolisers (*3*3) and Group B made of intermediate metaboliser (*1*3) or Extensive metaboliser (*1*1) . The Initial tacrolimus drug dosages were Planned according to the metaboliser status ie Lower doses started for group A and Higher doses started for Group B.
RESULTS


Out of 93 patients 37 patients (39 %) were found to be Poor metabolisers, 9 patients (9.6 %) extensive metabolisers and 47 patients (50.5 %) Intermediate metabolisers . Statistical analysis was done using One way Analysis of variance for independent variables (ANOVA) . The Average time taken to reach Optimal Tacrolimus trough levels was 8.9 days in Group A versus 14.6 days in group B (p< 0.0001), Average tacrolimus Trough levels at 1 month after Transplantation was 9.7 ng/ml in group A versus 7.8 ng/ml in group B (p=NS), Average tacrolimus dose was 1.8 mg in group A and 4.07 mg in group B at 1 month (P > 0.0001) and Incidence of renal dysfunction (upto 6 months) was 18 cases out of which 8 patients were poor metabolisers (44. 5 %) . Clinical rejection episodes were seen in 9 patients .
CONCLUSION


The Incidence of CYP poor metaboliser Status in Indian Patients were Found to be Midway between Caucasians and Africans. We find that Poor metabolisers Take a Shorter time to achieve Optimal tacrolimus levels after thoracic organ transplants and Similar Trough levels seen in all Patients if the Initial Tacrolimus Dose is tailored as per the CYP3A5 status, thus reducing chances of renal dysfunction, drug related side effects and Rejection .",2020,"We find that Poor metabolisers Take a Shorter time to achieve Optimal tacrolimus levels after thoracic organ transplants and Similar Trough levels seen in all Patients if the Initial Tacrolimus Dose is tailored as per the CYP3A5 status, thus reducing chances of renal dysfunction, drug related side effects and Rejection .","['The age range was 12 yrs to 72 yrs (70 M, 23 F) .Pattern of expression of 2 alleles', '93 patients', 'Caucasian and Afro - American patients', 'Heart and Lung Transplant Cases - An Indian Study', 'Indian Patients', '93 Heart, lung and Combined Heart plus lung transplant patients from our Hospital with 6 months Followup ']",[],"['Average time taken to reach Optimal Tacrolimus trough levels', 'Average tacrolimus Trough levels', 'Incidence of renal dysfunction', 'Tacrolimus levels', 'Incidence of CYP poor metaboliser Status', 'Clinical rejection episodes']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0018833', 'cui_str': 'Heart and lung transplant'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0519826', 'cui_str': 'Tacrolimus measurement'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",93.0,0.0154714,"We find that Poor metabolisers Take a Shorter time to achieve Optimal tacrolimus levels after thoracic organ transplants and Similar Trough levels seen in all Patients if the Initial Tacrolimus Dose is tailored as per the CYP3A5 status, thus reducing chances of renal dysfunction, drug related side effects and Rejection .","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ratnagiri', 'Affiliation': 'Heart and Lung Transplantation, Gleneagles Global Hospital, Chennai, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rahulan', 'Affiliation': 'Heart and Lung Transplantation, Gleneagles Global Hospital, Chennai, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Heart and Lung Transplantation, Gleneagles Global Hospital, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Attawar', 'Affiliation': 'Heart and Lung Transplantation, Gleneagles Global Hospital, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Heart and Lung Transplantation, Gleneagles Global Hospital, Chennai, India.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.107']
2565,32465971,Hemodynamic Effects of Sacubitril-Valsartan in Heart Failure with Reduced-Ejection Fraction: Are All Doses Created Equal?,"PURPOSE


Paradigm HF trial showed that Sacubitril/Valsartan (LCZ696) 97/103 mg bid reduces the risk of death and hospitalizations for heart failure (HF). We tested the hypothesis that this clinical benefit is reflected by changes in hemodynamic profile in a population of patients (pts) affected by advanced HF.
METHODS


Among pts included in our prospective HF Registry, we enrolled those who underwent two right heart catheterizations (RHC) and started LCZ696 in between, from May 2017 to April 2019. Baseline and follow-up RHC were compared in a matched paired fashion. We collected hemodynamic, clinical and echocardiographic data at both RHC. The dose of LCZ696 was expressed as a percentage of the target dose (TD,97/103 mg bid). The endpoint were hemodynamic changes between the two RHC. Changes in symptoms, echo parameters and medical therapy were also assessed.
RESULTS


44 pts (88% males; 54±8 yrs; 50% DCM; systolic blood pressure 108±17 mmHg; LVEF: 27±5%; NYHA III-IV: 46%) underwent a baseline RHC, started LCZ696 few days after, then repeated a RHC 178±59 days after the beginning of LCZ696. All pts were on diuretics (including MRAs), ACE-i/ARBs and beta-blockers at baseline. By comparing the two RHC, we observed a significant reduction in right atrial (from 7.5±2.5 to 5.6±2.5 mmHg), mean pulmonary artery (from 31.0±10.4 to 26.5±10.2 mmHg), pulmonary capillary wedge pressures (from 19.8±7.7 to 17.9±8.5 mmHg), transpulmonary gradient (from 10.4±4.6 to 8.6±3.8 mmHg) and pulmonary vascular resistances (from 2.7±1.5 to 2.2±1.3 WU), (p ≤ 0.01 for all), without significant change in systolic and mean systemic pressure. 50% of pts were taking ≤ 37.5% % of the TD; the hemodynamic changes were not influenced by LCZ696 dose. NYHA class improved (III-IV: 40.4 vs 16.7%, p<0.01) and mitral regurgitation greater than moderate was numerically reduced (40.4 vs 28.5%, p=0.09). Diuretics and beta-blockers doses did not change significantly after starting LCZ696. LCZ696 was not interrupted due to hypotension or side effects during the study period.
CONCLUSION


Our study shows that LCZ696 improves hemodynamic profile and symptoms in pts with advanced HF by reducing pulmonary and left ventricular filling pressures. This effect seems to be dose-independent. Our results suggest that LCZ696 can lead to a significant clinical and hemodynamic improvement even at low doses.",2020,"NYHA class improved (III-IV: 40.4 vs 16.7%, p<0.01) and mitral regurgitation greater than moderate was numerically reduced (40.4 vs 28.5%, p=0.09).","['in between, from May 2017 to April 2019', 'Heart Failure with Reduced-Ejection Fraction']","['Sacubitril-Valsartan', 'right heart catheterizations (RHC) and started LCZ696', 'Sacubitril/Valsartan (LCZ696', 'LCZ696']","['pulmonary vascular resistances', 'mitral regurgitation', 'hemodynamic changes', 'Changes in symptoms, echo parameters and medical therapy', 'pulmonary capillary wedge pressures', 'mean pulmonary artery', 'NYHA class', 'right atrial', 'hemodynamic profile and symptoms', 'systolic and mean systemic pressure', 'risk of death and hospitalizations for heart failure (HF']","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}]","[{'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.0371217,"NYHA class improved (III-IV: 40.4 vs 16.7%, p<0.01) and mitral regurgitation greater than moderate was numerically reduced (40.4 vs 28.5%, p=0.09).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Masetti', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Corazza', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giovannini', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Prestinenzi', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boschi', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Potena', 'Affiliation': 'Cardiovascular Department, University of Bologna, Bologna, Italy.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1236']
2566,32465975,Derivation and Validation of Three Novel Phenotypes of Cardiogenic Shock.,"PURPOSE


Cardiogenic shock (CS) mortality remains unacceptably high. Risk stratification of CS patients may improve trial design and treatment strategies. We tested the application of the expert consensus-based Society for Cardiovascular Angiography and Intervention (SCAI) CS stages in a retrospective dataset. Furthermore, we hypothesized that unsupervised clustering of CS patients is feasible and identifies clinically applicable phenotypes of CS.
METHODS


The Cardiogenic Shock Working Group (CSWG) registry is a retrospective multicenter registry of patients with all-cause CS. Descriptive analyses were performed on 1,414 CSWG patients to quantify the association of clinical variables and in-hospital mortality. In myocardial infarction-caused CS (AMICS) patients, a random forest classifier was used to identify variables that predict in-hospital mortality in CSWG. Consensus k means clustering was performed on these variables in 1,000 randomly assigned 85% samples of 408 AMICS patients from the CSWG training cohort and 701 AMICS patients from the Danish National Patient Registry (DNPR). CSWG patients with heart failure (CSWG-HF, n=480) were then assigned to the clusters.
RESULTS


Variables associated with in-hospital mortality in all-cause CS included SCAI Stages, but also pulmonary artery catheter use, and venous congestion. In AMICS the mortality driving continuous variables comprised glomerular filtration rate, lactate, HCO3, platelets, alanine aminotransferase, and white blood cell count. Independent, unsupervised consensus k means clustering on these variables identified three phenotypes of CS that were associated with in-hospital mortality in similar patterns in CSWG, DNPR, and CSWG-HF. The phenotypes revealed unique demographic, clinical, metabolic and hemodynamic profiles.
CONCLUSION


This is the first report to employ an unbiased, machine learning approach in CS and identified 3 phenotypes of patients with CS due to MI. These findings may inform treatment strategies and future CS clinical trials.",2020,"In AMICS the mortality driving continuous variables comprised glomerular filtration rate, lactate, HCO3, platelets, alanine aminotransferase, and white blood cell count.","['patients with CS due to MI', '1,000 randomly assigned 85% samples of 408 AMICS patients from the CSWG training cohort and 701 AMICS patients from the Danish National Patient Registry (DNPR', 'CSWG patients with heart failure (CSWG-HF, n=480', 'patients with all-cause CS']",[],"['glomerular filtration rate, lactate, HCO3, platelets, alanine aminotransferase, and white blood cell count', 'pulmonary artery catheter use, and venous congestion', 'hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0179790', 'cui_str': 'Pulmonary artery flotation catheter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0042484', 'cui_str': 'Passive congestion'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",1414.0,0.0271752,"In AMICS the mortality driving continuous variables comprised glomerular filtration rate, lactate, HCO3, platelets, alanine aminotransferase, and white blood cell count.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Thayer', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zweck', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Helgestad', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ayouty', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Josiassen', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Garan', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hernandez-Montfort', 'Affiliation': 'Cleveland Clinic Florida, Weston, FL.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Møller', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kapur', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1241']
2567,32466016,Alpha 1 Antitrypsin Treatment during Human Ex Vivo Lung Perfusion Improves Lung Function by Protecting Lung Endothelium.,"PURPOSE


The majority of potential donor lungs are not being used. The primary reason for underutilization is the concern for primary graft dysfunction (PGD). There is currently no clinically available therapy for PGD. Alpha 1 antitrypsin (A1AT) is a serine protease inhibitor with anti-inflammatory and cytoprotective properties. We and others have shown benefits of A1AT in small and large animal lung transplant studies. Before performing clinical trials, evidence of therapeutic efficacy in human lungs would be valuable. We tested the effect of A1AT given during ex vivo lung perfusion (EVLP) to human lungs rejected for transplantation.
METHODS


Double lung blocks rejected for transplantation (n=8) were divided and placed on separate EVLP circuits for 12h. Lungs were randomly assigned to receive A1AT or placebo, with the contralateral lung serving as control for the treated lung. Outcome measures included: hourly physiologic lung function, perfusate loss, wet-dry weight ratio, inflammatory mediators, endothelin-1 (ET-1), and zonula occludens tight junction protein-1 (ZO-1, immunofluorescence staining).
RESULTS


The A1AT-treated group demonstrated significantly better lung function: higher pO 2  and compliance (Fig A), lower pulmonary artery pressure (-0.4 mmHg p= 0.04) and vascular resistance (-30.4 dynes·s cm -5  p= 0.01). Perfusate loss, a surrogate for lung permeability, was lower in the A1AT group, as was the wet-dry ratio (Fig B). A1AT also decreased ET-1 levels in perfusate (Fig C) and increased ZO-1 expression on endothelial cells (Fig D).
CONCLUSION


In this study we demonstrated that human A1AT was able to improve the quality of severly injuried human lungs, likely through endothelial cell protection. The encouraging results justify a clinical trial, in order to improve donor lung quality and clinical outcomes in lung transplantation. Our study also illustrates that testing selected drugs on injured human lungs on EVLP is a viable strategy prior to clinical application.",2020,"A1AT also decreased ET-1 levels in perfusate (Fig C) and increased ZO-1 expression on endothelial cells (Fig D).
","['Double lung blocks rejected for transplantation (n=8', 'lung transplantation']","['A1AT given during ex vivo lung perfusion (EVLP', 'EVLP', 'A1AT or placebo']","['ET-1 levels', 'Perfusate loss, a surrogate for lung permeability', 'vascular resistance', 'hourly physiologic lung function, perfusate loss, wet-dry weight ratio, inflammatory mediators, endothelin-1 (ET-1), and zonula occludens tight junction protein-1 (ZO-1, immunofluorescence staining', 'ZO-1 expression on endothelial cells (Fig D', 'lung function: higher pO 2  and compliance (Fig A), lower pulmonary artery pressure']","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0454149', 'cui_str': 'Lung block'}, {'cui': 'C4319517', 'cui_str': 'Order rejected'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242358', 'cui_str': 'Tight junction'}, {'cui': 'C1451683', 'cui_str': 'TJP1 protein, human'}, {'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}]",8.0,0.0294225,"A1AT also decreased ET-1 levels in perfusate (Fig C) and increased ZO-1 expression on endothelial cells (Fig D).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mariscal', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nykanen', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tikkanen', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Soltanieh', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galasso', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juvet', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martinu', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Thoracic Surgery, Latner Thoracic Surgery Research Laboratories, Toronto General Research Institute, University Health Network, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1282']
2568,32466056,Effect of Donor Simvastatin Treatment on Gene Expression Profiles in Human Cardiac Allografts during Ischemia-Reperfusion Injury.,"PURPOSE


Numerous studies have shown that statin therapy initiated early after heart transplantation has beneficial effects on the development of cardiac allograft vasculopathy. Recently, we were able to show in a randomized clinical trial that simvastatin treatment of brain-dead donors conditions the heart transplant to withstand ischemia-reperfusion injury and to reduce the need for rejection treatments early after transplantation. In this study, we analyzed myocardial gene expression profiles in cardiac allografts after donor simvastatin treatment.
METHODS


84 heart transplant donors received 80 mg of simvastatin via nasogastric tube (n=42), or no treatment (n=42) in a prospective, double-blinded randomized controlled trial. Transmural Tru-Cut biopsies were taken from the apex of the donor heart's left ventricle immediately before reperfusion and 1 hour after reperfusion. The transcriptome of the biopsies will be analyzed with RNA sequencing.
RESULTS


The preliminary analysis of RNA sequencing data from myocardial biopsies of 20 + 20 patients revealed altogether 137 significantly differentially expressed genes in all pairwise comparisons. The overall biological functions of these genes were related to gene ontology terms such as response to toxic substance, leukocyte migration, neutrophil mediated immunity, response to lipopolysaccharide, and response to oxidative stress. Enrichment pathway analysis indicated alterations in Th17, TGF-β, and muscle repair signaling pathways. At time of abstract submission, data of the remaining samples is about to enter the sequencing data analysis pipeline.
CONCLUSION


We have shown in previous studies that donor simvastatin treatment induces protective effects against IRI in heart transplant recipients. In this study, we were able to detect significantly differentially expressed genes related to effects of simvastatin treatment. In order to single out genes that show beneficial effects of simvastatin treatment, further analysis will be conducted by exploring gene expression changes in specific biological functional categories, such as interleukin signaling and neutrophil degranulation. The complete analysis will be presented at the ISHLT 2020 congress.",2020,The preliminary analysis of RNA sequencing data from myocardial biopsies of 20 + 20 patients revealed altogether 137 significantly differentially expressed genes in all pairwise comparisons.,"['heart transplant recipients', '84 heart transplant donors received 80 mg of', 'cardiac allografts after donor simvastatin treatment', 'Human Cardiac Allografts during Ischemia-Reperfusion Injury']","['simvastatin', 'simvastatin via nasogastric tube (n=42), or no treatment', 'Donor Simvastatin']",['overall biological functions'],"[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0564471', 'cui_str': 'Allograft heart'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0442474', 'cui_str': 'Via nasogastric tube'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3714634', 'cui_str': 'Biological Process'}]",,0.0893124,The preliminary analysis of RNA sequencing data from myocardial biopsies of 20 + 20 patients revealed altogether 137 significantly differentially expressed genes in all pairwise comparisons.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krebs', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmström', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dhaygude', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kankainen', 'Affiliation': 'Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Syrjälä', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lukac', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mattila', 'Affiliation': 'Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nykänen', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lemström', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1320']
2569,32466070,Prolonged Release Tacrolimus Has Comparable Safety and Efficacy Profile as Standard Release Tacrolimus in Heart Transplant Recipients.,"PURPOSE


Current data on safety and efficacy of prolonged release tacrolimus (PRT, Advagraf) in heart transplant (HTX) recipients is scarce. We sought to compare standard release tacrolimus (SRT) to PRT in this patient population.
METHODS


In a prospective cross-over single-center study we enrolled 70 HTX recipients transplanted between 2014 and 2017. In Phase 1 all patients received SRT and were followed for 6 months. Then SRT was switched for PRT (Phase 2) and the patients were followed for another 6 months. Target tacrolimus trough values for SRT and PRT in Phases 1 and 2 were 5-8 ng/mL. Renal dysfunction was defined as estimated glomerular filtration rate (eGFR)<90mL/min/1.73m 2 .
RESULTS


Of 70 patients enrolled, 56 (80%) were male with the average age of 56±10 years, 40 (57%) had renal dysfunction, 16 (23%) had diabetes and 41 (59%) had hypertension. When comparing the two treatment strategies we found no differences regarding tacrolimus trough levels (7.1±1.4 ng/mL in SRT vs. 7.2±1.6 ng/mL in PRT, P=0.57) or cumulative drug dose (3.1±1.6 mg vs. 3.6±1.8 mg, P=0.11). Furthermore, we found no differences in eGFR (75±14 mL/min/1.73m 2  in SRT vs. 73±18 mL/min/1.73m 2  in PRT, P=0.69), Cystatin C levels (1.11±0.27 mg/dL vs. 1.08±0.33 mg/dL, P=0.68), glucose metabolism (HbA1c: 5.9±0.9% vs. 5.8±1.0%, P=0.68), allograft left ventricular ejection fraction (65±7% vs. 66±6%, P=0.84) or right ventricular function (TAPSE: 1.7±0.7 cm vs. 1.8±0.3 cm, P=0.39). Troponin levels (0.01±0.01 pg/mL in SRT vs. 0.01±0.02 pg/mL in PRT, P=0.29) and allograft rejection rates (0% in SRT vs. 1% in PRT, P=0.32) remained comparable. When stratifying patients according to the baseline eGFR no decline was observed in patients with either normal renal function (ΔeGFR -2.2±5.1 mL/min/1.73m 2  in SRT vs. +0.6±5.6 mL/min/1.73m 2  in PRT, P=0.19) or decreased renal function (ΔeGFR -0.9±7.7 mL/min/1.73m 2  in SRT vs. -0.7±8.9 mL/min/1.73m 2  in PRT, P=0.95).
CONCLUSION


Prolonged-release tacrolimus may represent a safe and effective alternative to standard-release tacrolimus in heart transplant recipients.",2020,"When comparing the two treatment strategies we found no differences regarding tacrolimus trough levels (7.1±1.4 ng/mL in SRT vs. 7.2±1.6 ng/mL in PRT, P=0.57) or cumulative drug dose (3.1±1.6 mg vs. 3.6±1.8 mg, P=0.11).","['enrolled 70 HTX recipients transplanted between 2014 and 2017', 'heart transplant (HTX) recipients', 'Of 70 patients enrolled, 56 (80%) were male with the average age of 56±10 years, 40 (57%) had renal dysfunction, 16 (23%) had diabetes and 41 (59%) had hypertension', 'Heart Transplant Recipients', 'heart transplant recipients']","['tacrolimus (PRT, Advagraf', 'Tacrolimus', 'SRT', 'tacrolimus (SRT']","['Troponin levels', 'Cystatin C levels', 'renal function', 'right ventricular function', 'tacrolimus trough levels', 'allograft rejection rates', 'eGFR', 'normal renal function', 'glucose metabolism', 'glomerular filtration rate', 'allograft left ventricular ejection fraction']","[{'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",70.0,0.0408605,"When comparing the two treatment strategies we found no differences regarding tacrolimus trough levels (7.1±1.4 ng/mL in SRT vs. 7.2±1.6 ng/mL in PRT, P=0.57) or cumulative drug dose (3.1±1.6 mg vs. 3.6±1.8 mg, P=0.11).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Poglajen', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zemljič', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Frljak', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Okrajšek', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Šebeštjen', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cerar', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Andročec', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vrtovec', 'Affiliation': 'Advanced Heart Failure and Transplantation Center, University Medical Center, Ljubljana, Slovenia.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.938']
2570,32466147,The Effects of Multifaceted Ergonomic Interventions on Musculoskeletal Complaints in Intensive Care Units.,"Working at intensive care units (ICUs) is considered a risk factor for developing musculoskeletal complaints (MSC). This study was conducted between January 2017 and June 2019 in two ICUs of a university hospital. It was designed as a pre- and post-assessment of the intervention group (IG) (N = 27) compared with a control group (CG) (N = 23) to determine the effects of a multifaceted ergonomics intervention program in reducing MSC. The IG (N: 35) received a multifaceted ergonomic intervention program, which was implemented by an ERGO team over an 18 month period. Four ergonomic interventions were planned as follows: individual level interventions such as training; stretching exercises and motivation meetings; administrative intervention such as a daily 10 min stretching exercises break; engineering interventions such as lifting and usage of auxiliary devices. The CG (N:29) did not receive any intervention. Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) was used to assess MSC in both groups. At the start of the intervention, both groups were similar concerning the number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores ( p  > 0.05 for all). Two factor repeated ANOVA measures were performed for between-groups and within-group analyses. The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001). However, the interaction effect of group and time (between and within factors) was not significant ( p  = 0.992). Work-related MSC is a common occupational health problem among nurses. This study showed that individual-level interventions are not likely to succeed in eliminating manual patient lifting by nurses. Our results suggested that interventions without administrative measures might have limited success.",2020,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001).,"['Musculoskeletal Complaints in Intensive Care Units', 'January 2017 and June 2019 in two ICUs of a university hospital']","['multifaceted ergonomics intervention program', 'multifaceted ergonomic intervention program', 'Multifaceted Ergonomic Interventions']","['number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores', 'mean of the initial CMSDQ total scores', 'Cornell Musculoskeletal Discomfort Questionnaire (CMDQ']","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0244086,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001).,"[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Coskun Beyan', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Dilek', 'Affiliation': 'Physical Therapy and Rehabilitation Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Yucel', 'Initials': 'Y', 'LastName': 'Demiral', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}]",International journal of environmental research and public health,['10.3390/ijerph17103719']
2571,32466168,Targeted Nutritional Intervention for Patients with Mild Cognitive Impairment: The Cognitive impAiRmEnt Study (CARES) Trial 1.,"Omega-3 fatty acids (ω-3FAs), carotenoids, and vitamin E are important constituents of a healthy diet. While they are present in brain tissue, studies have shown that these key nutrients are depleted in individuals with mild cognitive impairment (MCI) in comparison to cognitively healthy individuals. Therefore, it is likely that these individuals will benefit from targeted nutritional intervention, given that poor nutrition is one of the many modifiable risk factors for MCI. Evidence to date suggests that these nutritional compounds can work independently to optimize the neurocognitive environment, primarily due to their antioxidant and anti-inflammatory properties. To date, however, no interventional studies have examined the potential synergistic effects of a combination of ω-3FAs, carotenoids and vitamin E on the cognitive function of patients with MCI. Individuals with clinically confirmed MCI consumed an ω-3FA plus carotenoid plus vitamin E formulation or placebo for 12 months. Cognitive performance was determined from tasks that assessed global cognition and episodic memory. Ω-3FAs, carotenoids, and vitamin E were measured in blood. Carotenoid concentrations were also measured in tissue (skin and retina). Individuals consuming the active intervention ( n  = 6; median [IQR] age 73.5 [69.5-80.5] years; 50% female) exhibited statistically significant improvements ( p  < 0.05, for all) in tissue carotenoid concentrations, and carotenoid and ω-3FA concentrations in blood. Trends in improvements in episodic memory and global cognition were also observed in this group. In contrast, the placebo group ( n  = 7; median [IQR] 72 (69.5-75.5) years; 89% female) remained unchanged or worsened for all measurements ( p  > 0.05). Despite a small sample size, this exploratory study is the first of its kind to identify trends in improved cognitive performance in individuals with MCI following supplementation with ω-3FAs, carotenoids, and vitamin E.",2020,Trends in improvements in episodic memory and global cognition were also observed in this group.,"['patients with MCI', 'individuals with mild cognitive impairment (MCI) in comparison to cognitively healthy individuals', 'Patients with Mild Cognitive Impairment']","['Omega-3 fatty acids (ω-3FAs), carotenoids, and vitamin E', 'Targeted Nutritional Intervention', 'ω-3FAs, carotenoids and vitamin E', 'placebo']","['cognitive performance', 'episodic memory and global cognition', 'global cognition and episodic memory', 'tissue carotenoid concentrations, and carotenoid and ω-3FA concentrations in blood', 'Carotenoid concentrations', 'Ω-3FAs, carotenoids, and vitamin E', 'Cognitive performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]",,0.037783,Trends in improvements in episodic memory and global cognition were also observed in this group.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Power', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 K0EK Waterford, Ireland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Nolan', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 K0EK Waterford, Ireland.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Prado-Cabrero', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 K0EK Waterford, Ireland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coen', 'Affiliation': ""Mercer's Institute for Research on Ageing, St. James's Hospital, D08 NHY1 Dublin, Ireland.""}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Roche', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 K0EK Waterford, Ireland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Power', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 K0EK Waterford, Ireland.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Howard', 'Affiliation': 'Howard Foundation, 7 Marfleet Close, Great Shelford, Cambridge CB22 5LA, UK.'}, {'ForeName': 'Ríona', 'Initials': 'R', 'LastName': 'Mulcahy', 'Affiliation': 'Age-Related Care Unit, Health Service Executive, University Hospital Waterford, Dunmore Road, X91 ER8E Waterford, Ireland.'}]",Journal of personalized medicine,['10.3390/jpm10020043']
2572,32466187,Effect of Different Running Exercise Modalities on Post-Exercise Oxidative Stress Markers in Trained Athletes.,"The aim of this study was to examine the effect of running exercise modality on oxidative stress. Thirteen endurance athletes (age: 21.46 ± 0.66 years) performed three different running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max  for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max , 30 s passive recovery, performed for 50 min) in a randomized order. Blood samples were drawn at rest and immediately after each running exercise and assessed for malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities. MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise. SOD increased after CR (+13.9%,  p  < 0.05), and also remained unchanged after 15/15 ( p  > 0.05) and decreased after 30/30 (-19.7%  p  < 0.05). GPX and AOPP did not change after exercise in all experimental sessions ( p  > 0.05). In conclusion, 30/30 intermittent running induced higher lipid damages than the 15/15 and CR exercise. 15/15 intermittent exercise promoted a better balance between free radicals production and antioxidant defense compared to continuous exercise and intermittent 30/30 exercise.",2020,"MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise.","['Thirteen endurance athletes (age: 21.46 ± 0.66 years', 'Trained Athletes']","['running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max  for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max', 'Different Running Exercise Modalities', 'running exercise modality']","['SOD', 'oxidative stress', 'malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities', 'GPX and AOPP', 'MDA', 'lipid damages', 'Post-Exercise Oxidative Stress Markers']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",13.0,0.0473095,"MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise.","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Farjallah', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Ben Mahmoud', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mariem', 'Initials': 'M', 'LastName': 'Boudaya', 'Affiliation': 'Biochemistry Laboratory, CHU HediChaker, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Institute of Sport and Sport Science, Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Zouheir', 'Initials': 'Z', 'LastName': 'Sahnoun', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103729']
2573,32466190,The Effect of Physical Activity and High Body Mass Index on Health-Related Quality of Life in Individuals with Metabolic Syndrome.,"The main objective of this study was to examine the relationship between the level of physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL) in individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study. A total of 6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers. Subjects were classified according to categories of body mass index (BMI). PA was measured with the validated Registre Gironí del Cor (REGICOR) questionnaire and subjects were classified according to their PA level (light, moderate, vigorous) and the HRQoL was measured with the validated short-form 36 (SF-36) questionnaire. By using the ANOVA model, we found a positive and statistically significant association between the level of PA and the HRQoL (aggregated physical and mental dimensions  p  < 0.001), but a negative association with higher BMI in aggregated physical dimensions  p  < 0.001. Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36. Therefore, it is essential to promote PA and body weight control from primary care consultations to improve HRQoL, paying special attention to the differences that sex incurs.",2020,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","['6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers', 'Individuals with Metabolic Syndrome', 'individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study']",['Physical Activity and High Body Mass Index'],"['level of PA and the HRQoL', 'physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6875.0,0.0214871,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Marcos-Delgado', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Fernández-Villa', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J LLuís', 'Initials': 'JL', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Molina', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Babio', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ignacio M', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vaquero-Luna', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pastor-Morel', 'Affiliation': 'Centro de Salud Cabo Huertas, 03540 Alicante, Spain.'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Galmes-Panades', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Rios', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Bernal-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorin', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Zenaida', 'Initials': 'Z', 'LastName': 'Vázquez-Ruiz', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sorto-Sánchez', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Palau-Galindo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Galilea-Zabalza', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Muñoz-Martínez', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martín', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103728']
2574,32466231,Taurine Supplementation Increases Post-Exercise Lipid Oxidation at Moderate Intensity in Fasted Healthy Males.,"Based on the fact that taurine can increase lipid metabolism, the objective of the present study was to evaluate the effects of different doses of acute taurine supplementation on lipid oxidation levels in healthy young men after a single bout of fasting aerobic exercise. A double-blind, acute, and crossover study design was conducted. Seventeen men (age 24.8 ± 4.07y; BMI: 23.9 ± 2.57 kg/m²) participated in the present study. Different doses of taurine (TAU) (3 g or 6 g) or placebo were supplemented 90 minutes before a single bout of fasting aerobic exercise (on a treadmill at 60% of VO2 max). The subjects performed three trials, and each one was separated by seven days. Blood samples were collected at baseline and after the exercise protocol of each test to analyze plasma levels of glycerol and taurine. Lipid and carbohydrate oxidation were determined immediately after exercise for 15 minutes by indirect calorimetry. We observed that TAU supplementation (6 g) increased lipid oxidation (38%) and reduced the respiratory coefficient (4%) when compared to the placebo ( p  < 0.05). However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g). For glycerol concentrations, there were no differences between trials. Six grams of TAU supplementation 90 minutes before a single bout of aerobic exercise in a fasted state was sufficient to increase the lipid oxidation post-exercise in healthy young men.",2020,"However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g).","['Seventeen men (age 24.8 ± 4.07y; BMI: 23.9 ± 2.57 kg/m²) participated in the present study', 'healthy young men after a single bout of fasting aerobic exercise', 'healthy young men', 'Fasted Healthy Males']","['taurine', 'Taurine Supplementation', 'taurine (TAU', 'acute taurine supplementation', 'fasting aerobic exercise', 'aerobic exercise', 'TAU supplementation', 'placebo']","['lipid oxidation levels', 'lipid oxidation post-exercise', 'lipid metabolism', 'Blood samples', 'respiratory coefficient', 'lipid oxidation', 'Lipid and carbohydrate oxidation']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",,0.193798,"However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g).","[{'ForeName': 'Milena Barbon de', 'Initials': 'MB', 'LastName': 'Carvalho', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Faculty of Physical Education, State University of Minas Gerais, Divinopolis 35501-170, Brazil.'}, {'ForeName': 'Priscila Giacomo', 'Initials': 'PG', 'LastName': 'Fassini', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Thiago Mantello', 'Initials': 'TM', 'LastName': 'Bianco', 'Affiliation': 'Ribeirao Preto Medical School. Department of Clinical Oncology, Stem Cells, and Cell Therapy. University of Sao Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Bryan Steve Martinez', 'Initials': 'BSM', 'LastName': 'Galan', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sports of Ribeirao Preto University of São Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Tales Sambrano', 'Initials': 'TS', 'LastName': 'Vieira', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferriolli', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Adelino Sanchez Ramos da', 'Initials': 'ASRD', 'LastName': 'Silva', 'Affiliation': 'School of Physical Education and Sports of Ribeirao Preto University of São Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}]",Nutrients,['10.3390/nu12051540']
2575,32466360,"Effects of Anesthesia Techniques on Outcomes after Hip Fracture Surgery in Elderly Patients: A Prospective, Randomized, Controlled Trial.","The superiority of distinct anesthesia methods for geriatric hip fracture surgery remains unclear. We evaluated high mobility group box-1 (HMGB1) and interleukin-6 (IL-6) with three different anesthesia methods in elderly patients undergoing hip fracture surgery. Routine blood test findings, postoperative morbidity, and mortality were assessed as secondary outcome. In total, 176 patients were randomized into desflurane ( n  = 60), propofol ( n  = 58), or spinal groups ( n  = 58) that received desflurane-based balanced anesthesia, propofol-based total intravenous anesthesia (TIVA), or spinal anesthesia, respectively. The spinal group required less intraoperative vasopressors ( p  < 0.001) and fluids ( p  = 0.006). No significant differences in HMGB1 ( p group×time  = 0.863) or IL-6 ( p group×time  = 0.575) levels were noted at baseline, postoperative day (POD) 1, or POD2. Hemoglobin, albumin, creatinine, total lymphocyte count, potassium, troponin T, and C-reactive protein were comparable among groups at all time-points. No significant differences in postoperative hospital stay, intensive care unit (ICU) stay, and ventilator use among groups were observed. Postoperative pulmonary, cardiac, and neurologic complications; and in-hospital, 30-day, and 90-day mortality were not significantly different among groups ( p  = 0.974). In conclusion, HMGB1 and IL-6, and all secondary outcomes, were not significantly different between desflurane anesthesia, propofol TIVA, and spinal anesthesia.",2020,"No significant differences in postoperative hospital stay, intensive care unit (ICU) stay, and ventilator use among groups were observed.","['Elderly Patients', 'geriatric hip fracture surgery', '176 patients were randomized into', 'elderly patients undergoing hip fracture surgery']","['desflurane', 'Anesthesia Techniques', 'high mobility group box-1 (HMGB1) and interleukin-6 (IL-6) with three different anesthesia methods', 'propofol', 'desflurane-based balanced anesthesia, propofol-based total intravenous anesthesia (TIVA), or spinal anesthesia, respectively']","['HMGB1', 'intraoperative vasopressors', 'postoperative hospital stay, intensive care unit (ICU) stay, and ventilator use', 'IL-6', 'Hemoglobin, albumin, creatinine, total lymphocyte count, potassium, troponin T, and C-reactive protein', 'Postoperative pulmonary, cardiac, and neurologic complications; and in-hospital, 30-day, and 90-day mortality', 'postoperative morbidity, and mortality', 'desflurane anesthesia, propofol TIVA, and spinal anesthesia']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936341', 'cui_str': 'Balanced Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]",176.0,0.0595164,"No significant differences in postoperative hospital stay, intensive care unit (ICU) stay, and ventilator use among groups were observed.","[{'ForeName': 'Seokyung', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Kwan Kyu', 'Initials': 'KK', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Seon Ju', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, National Health Insurance Service Ilsan Hospital, Goyang 10444, Korea.'}, {'ForeName': 'Jae Chan', 'Initials': 'JC', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, National Health Insurance Service Ilsan Hospital, Goyang 10444, Korea.'}, {'ForeName': 'Yong Seon', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9061605']
2576,32466396,Does Post-Activation Performance Enhancement Occur During the Bench Press Exercise under Blood Flow Restriction?,"Background :  The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) during successive sets of the bench press (BP) exercise under blood flow restriction (BFR). Methods :  The study included 10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction. During the experimental sessions, the study participants performed 3 sets of 3 repetitions of the BP exercise at 70%1RM with a 5 min rest interval between sets. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions were examined using 2-way (condition × set) repeated measures ANOVA. Furthermore, t-test comparisons between conditions were made for the set 2-set 1, set 3-set 1, and set 3-set 2 delta values for all variables. Results :  The post hoc results for condition × set interaction in PP showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for the CONT ( p  = 0.01) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition occurred ( p  < 0.01). The post hoc results for condition × set interaction in PV showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for CONT ( p  = 0.03) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition ( p  < 0.01). The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions. Conclusion :  The PAPE effect was analyzed through changes in power output and bar velocity that occurred under both the CONT and BFR conditions. However, the effects of PAPE have different kinetics in successive sets for BFR and for CONT conditions.",2020,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,['10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg'],"['exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction', 'PAPE', 'post-activation performance enhancement (PAPE', 'BP exercise']","['peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions', 'PP', 'BFR condition', 'blood flow restriction (BFR', 'power output and bar velocity']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",10.0,0.0189799,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Physical Pharmacy, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Center for Sports Performance, Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17113752']
2577,32466446,Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial.,"The efficacy of exercise to reverse frailty in the aging population has not been extensively investigated. This study aimed to investigate the effectiveness of a multicomponent exercise program (MCEP) on frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP)) in frail older adults. A randomized controlled trial using an allocation concealment method, included 64 older adults (77.78 ± 7.24 years), were divided into two parallel groups using block randomization: an MCEP group ( n  = 32) and a control group ( n  = 32). The combined center- and home-based MCEP training consisted of chair aerobic, resistance, and balance, which was carried out 3 days per week for 24 weeks. A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001). Additionally, the post-hoc analysis revealed that the MCEP group showed significantly improved BBS, TUG, and frailty scores ( p  < 0.01), at both 12- and 24-weeks. When compared with controls at 12-weeks, the MCEP group decreased IL-6 and CRP levels ( p  < 0.05). The combined center- and home-based MCEP were effective in reversing frailty to pre-frailty and improving physical performance especially balance in the older population.",2020,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001).","['frail older adults', 'Community-Dwelling Older Adults', '64 older adults (77.78 ± 7.24 years']","['Multicomponent Exercise Program', 'multicomponent exercise program (MCEP', 'MCEP', 'combined center- and home-based MCEP']","['BBS, TUG and frailty scores', 'Frailty and Inflammatory Biomarkers and Improves Physical Performance', 'frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP', 'BBS, TUG, and frailty scores', 'IL-6 and CRP levels']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0358322,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001).","[{'ForeName': 'Uratcha', 'Initials': 'U', 'LastName': 'Sadjapong', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17113760']
2578,32466496,Dance Fitness Classes Improve the Health-Related Quality of Life in Sedentary Women.,"This study aims to analyze the effect of two dance-focused and choreographic fitness classes on Health-Related Quality of Life (HRQoL) in sedentary worker women.  Methods :  65 sedentary middle-aged worker women (38 ± 7.3 years old) completed a 16-week intervention randomly assigned to: (1) dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group ( n  = 20). HRQoL was assessed by the 36-Item Short-Form Health-Survey (SF-36), which evaluates 8 dimensions of health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status).  Results : The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score. No statistical differences were observed between exercise groups post-intervention, except in V. DF group showed increases in GH, PF, SF, V, PR, and MH post-intervention.  Conclusion : A 16-week dance fitness intervention based on Zumba Fitness classes generates notable improvements in a wide range of HRQoL dimensions in sedentary middle-aged worker women, especially in V, PR and MH dimensions.",2020,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","['sedentary middle-aged worker women', '65 sedentary middle-aged worker women (38 ± 7.3 years old', 'Sedentary Women', 'sedentary worker women']","['dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group']","['Health-Related Quality of Life (HRQoL', 'HRQoL', 'health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status', 'GH, PF, SF, V, PR, and MH post-intervention', 'Health-Related Quality of Life', 'HRQoL dimensions']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",65.0,0.0337697,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Paz-Viteri', 'Affiliation': 'Pedagogy School of Physical Activity and Sports, Faculty of Education Sciences, National University of Chimborazo, 060150 Riobamba, Ecuador.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113771']
2579,32466528,Analysis of Usage Data from a Self-Guided App-Based Virtual Reality Cognitive Behavior Therapy for Acrophobia: A Randomized Controlled Trial.,"This study examined user engagement with ZeroPhobia, a self-guided app-based virtual reality (VR) Cognitive Behavior Therapy for acrophobia symptoms using cardboard VR viewers. Dutch acrophobic adults ( n  = 96) completed assessments at baseline and immediately following treatment. Primary outcome measures were the Acrophobia Questionnaire (AQ) and the Igroup Presence Questionnaire (IPQ). Usage data consisted of number of VR sessions practiced, practice time, and fear ratings directly after practicing. Results show that of the 66 participants who played at least one level, the majority continued to finish all levels, spending on average 24.4 min in VR. Self-reported fear consistently decreased between the start and finish of levels. Post-test AQ scores depended quadratically on time spent in VR. Higher pre-test AQ scores were significantly associated with subjective anxiety after the first level and a reduction of post-test AQ scores, but not with number of sessions, suggesting it might be more beneficial to play one level for a longer time period instead of practicing many VR levels. Results also show an optimum exposure level at which increasing practice time does not result in increased benefit. Self-guided VR acrophobia treatment is effective and leads to consistent reductions in self-reported anxiety both between levels and after treatment. Most participants progressed effectively to the highest self-exposure level, despite the absence of a therapist.",2020,Self-guided VR acrophobia treatment is effective and leads to consistent reductions in self-reported anxiety both between levels and after treatment.,"['Dutch acrophobic adults ( n  = 96', 'Acrophobia']","['Self-Guided App-Based Virtual Reality Cognitive Behavior Therapy', 'ZeroPhobia, a self-guided app-based virtual reality (VR) Cognitive Behavior Therapy']","['time spent in VR', 'Acrophobia Questionnaire (AQ) and the Igroup Presence Questionnaire (IPQ', 'subjective anxiety']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.01595,Self-guided VR acrophobia treatment is effective and leads to consistent reductions in self-reported anxiety both between levels and after treatment.,"[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Donker', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands.'}, {'ForeName': 'Chris van', 'Initials': 'CV', 'LastName': 'Klaveren', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics and Amsterdam Center for Learning Analytics, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Cornelisz', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics and Amsterdam Center for Learning Analytics, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kok', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Campusvej 55, 5230 Odense, Denmark.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'van Gelder', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Pieter de la Court Building, 4th floor, Wassenaarseweg 52, 2333 AK Leiden, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9061614']
2580,32466588,"Effect of Neuromuscular Electrical Stimulation on Masseter Muscle Thickness and Maximal Bite Force Among Healthy Community-Dwelling Persons Aged 65 Years and Older: A Randomized, Double Blind, Placebo-Controlled Study.","AIM


This study investigated the effect of neuromuscular electrical stimulation (NMES) on masseter muscle thickness and maximal bite force among healthy community-dwelling elderly persons older than 65 years.
MATERIALS AND METHODS


A total of 40 participants were randomly assigned to the experimental and placebo groups. In the experimental group, NMES was applied to both masseter muscles, and electrical signals were gradually increased until the participants felt a grabbing sensation (range 6.0-7.5 mA) in the masseter muscle. The placebo group, in contrast, underwent NMES in the same manner and procedure as the experimental group with less electrical intensity (0.5 mA). All interventions were administered five times a week for six weeks, 20 min per day. The outcomes were masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter. The level of significance was set as  p  < 0.05.
RESULTS


The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively). Moreover, the degree of change in the masseter muscle thickness and maximal bite force significantly increased in the experimental and placebo groups (p < 0.001, both).
CONCLUSIONS


This study demonstrated that NMES could be an effective modality for increasing masseter muscle thickness and maximal bite force in healthy older adults.",2020,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","['A total of 40 participants', 'healthy community-dwelling elderly persons older than 65 years', 'Aged 65 Years and Older', 'Healthy Community-Dwelling Persons', 'healthy older adults']","['Placebo', 'NMES', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'placebo']","['electrical intensity', 'Masseter Muscle Thickness and Maximal Bite Force', 'masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter', 'masseter muscle thickness and maximal bite force']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]",40.0,0.200011,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","[{'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, Inje University, Gimhae 50834, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science, Health Sciences Division, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113783']
2581,32466660,Compound Danshen Dripping Pill Promotes Adaptation to Acute High-Altitude Exposure.,"Background:  In this study, we aimed to investigate whether the traditional Chinese medicine, Compound Danshen Dripping Pill (CDDP), can prevent acute mountain sickness (AMS). We allocated CDDP and matching placebos to 160 volunteers before they ascended to a high altitude. Treadmill exercise tests, echocardiography, blood routine examinations, biochemical analysis, and blood gas analysis were performed upon arrival at high altitude. The primary outcome included incidence of AMS, exercise times, and metabolic equivalents (METs) of treadmill exercise tests. Second endpoints included the heart rates and rate-pressure product (RPP) before and after treadmill exercise tests.  Results:  After high-altitude exposure, the incidence of AMS in the CDDP group was lower than that in the placebo group (48.6% vs. 67.6%,  p  = 0.022). The exercise time of the treadmill exercise test was significantly longer (507 ± 77.9 seconds vs. 457 ± 90.8 seconds,  p  = 0.004), the heart rate was lower (pre-exercise: 91.8 ± 11.7 beats/min vs. 97.2 ± 12.7 beats/min,  p  = 0.016; postexercise: 114 ± 22.2 beats/min vs. 121 ± 22.6 beats/min,  p  = 0.019), the pre-exercise and postexercise RPP were lower (pre-exercise: 1.13 × 10 4  ± 1.68 × 10 3  mmHg·beats/min vs. 1.23 × 10 4  ± 1.84 × 10 3  mmHg·beats/min,  p  = 0.027; postexercise: 1.19 × 10 4  ± 1.75 × 10 3  mmHg·beats/min vs. 1.31 × 10 4  ± 2.00 × 10 3  mmHg·beats/min,  p  = 0.002), and the MET value of the treadmill exercise test was significantly higher (9.93 ± 1.18 METs vs. 9.31 ± 1.52 METs,  p  = 0.037) in the CDDP group.  Discussion:  CDDP decreases the incidence of AMS and enhances exercise tolerance greater than placebo after high-altitude exposure. CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.",2020,"CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.","['160 volunteers before they ascended to a high altitude', 'acute mountain sickness (AMS']","['traditional Chinese medicine, Compound Danshen Dripping Pill (CDDP', 'CDDP', 'CDDP and matching placebos', 'placebo']","['incidence of AMS and enhances exercise tolerance', 'Treadmill exercise tests, echocardiography, blood routine examinations, biochemical analysis, and blood gas analysis', 'incidence of AMS, exercise times, and metabolic equivalents (METs) of treadmill exercise tests', 'heart rate', 'pre-exercise and postexercise RPP', 'exercise time of the treadmill exercise test', 'levels of hemoglobin, hematocrit, and antioxidant factors', 'heart rate and myocardial oxygen consumption', 'heart rates and rate-pressure product (RPP', 'incidence of AMS']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0377336', 'cui_str': 'dan-shen root extract'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0314205,"CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.","[{'ForeName': 'Zongbin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Chunwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}]",High altitude medicine & biology,['10.1089/ham.2019.0126']
2582,32466676,Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial.,"BACKGROUND


Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited.
METHODS


The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization.
RESULTS


At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent ( P =0.55). Rates of cardiac death (3.9% versus 3.8%;  P =0.88), target vessel myocardial infarction (3.2% versus 2.5%;  P =0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%;  P =0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%;  P =0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%;  P =0.34).
CONCLUSIONS


In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.",2020,The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent.,[],"['ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent', 'MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent', 'novel ultrathin drug-eluting stent', 'MiStent sirolimus-eluting bioabsorbable polymer-coated stent', 'MiStent Sirolimus Eluting Absorbable Polymer Stent System']","['device-oriented composite end point', 'risk of patient-oriented composite end point', 'Rates of cardiac death', 'target vessel myocardial infarction', 'device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization', 'rate of definite or probable stent thrombosis', 'target lesion revascularization', 'composite of all-cause mortality, any myocardial infarction, or any revascularization']",[],"[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.070461,The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent.,"[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG) (P.W.S., Y.O.).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Department of Epidemiology and Statistics, Medical University of Silesia, Katowice, Poland (P.B.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University Leipzig, Germany (P.L.).'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Emmen, the Netherlands (G.A.J.J.).'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Roland P T', 'Initials': 'RPT', 'LastName': 'Troquay', 'Affiliation': 'Department of Cardiology, VieCuri Medical Centre for Northern Limburg, Venlo, the Netherlands (R.P.T.T.).'}, {'ForeName': 'B J B', 'Initials': 'BJB', 'LastName': 'Hamer', 'Affiliation': 'Department of Cardiology, Meander Medisch Centrum, Amersfoort, the Netherlands (B.J.B.H.).'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Oude Ophuis', 'Affiliation': 'Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.).'}, {'ForeName': 'Krzysztof P', 'Initials': 'KP', 'LastName': 'Milewski', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron (P.B., K.P.M.).'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (S.H.H.).'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG) (P.W.S., Y.O.).'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway (W.W.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008737']
2583,32466678,"Feasibility of Targeting Hispanic Fathers and Children in an Obesity Intervention: "" Papás Saludables Niños Saludables "".","Background:  Hispanic children and men carry a high burden for obesity and associated medical conditions.  Healthy Dads Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia. The aim of this study was to assess the feasibility of a culturally adapted version of the program for Hispanic families,  Papás Saludables Niños Saludables .  Methods:  A randomized waitlist controlled trial with a process evaluation was conducted to assess the feasibility of  Papás Saludables Niños Saludables   ( NCT03532048). Fathers, their partner (mother), and one to three children were enrolled.  A priori  feasibility criteria were: (1) recruit 40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4) obtain 80% ""excellent"" or ""good"" satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up.  Results:  The study enrolled 90% ( n  = 36) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% ""excellent/good"" satisfaction ratings among the participating fathers and mothers. One hundred percent of participants had most anthropometric and behavioral data at baseline and 72% at follow-up.  Conclusions:  With oversampling and improvements in the recruitment strategies,  Papás Saludables Niños Saludables  is feasible for a randomized controlled clinical trial to address whether a father-targeted lifestyle program is efficacious among low-income Hispanic men and their children.",2020,Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia.,"['Healthy Dads', 'low-income Hispanic men and their children', 'Hispanic children and men carry a high burden for obesity and associated medical conditions', 'Hispanic Fathers and Children in an Obesity Intervention', 'fathers and children in Australia', '40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4', 'Hispanic families,  Papás Saludables Niños Saludables ', 'The study enrolled 90% ( n \u2009=\u200936) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% ""excellent/good"" satisfaction ratings among the participating fathers and mothers', 'Fathers, their partner (mother), and one to three children were enrolled']","['obtain 80% ""excellent"" or ""good"" satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up']",['weight loss'],"[{'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015670', 'cui_str': 'Father-Child Relationship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",90.0,0.0374602,Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia.,"[{'ForeName': 'Teresia M', 'Initials': 'TM', 'LastName': ""O'Connor"", 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Beltran', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Musaad', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Perez', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Galdamez-Calderon', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Tasia', 'Initials': 'T', 'LastName': 'Isbell', 'Affiliation': 'School of Public Health, University of Texas, Houston, TX, USA.'}, {'ForeName': 'Elva M', 'Initials': 'EM', 'LastName': 'Arredondo', 'Affiliation': 'School of Public Health, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Ruben Parra', 'Initials': 'RP', 'LastName': 'Cardona', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Cabrera', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Marton', 'Affiliation': ""Texas Children's Health Plan, Houston, TX, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Faculty of Education and Arts, Priority Research Center for Physical Activity & Nutrition, University of Newcastle, Newcastle, New South Wales, Australia.'}]",Childhood obesity (Print),['10.1089/chi.2020.0006']
2584,32466710,Effects of acute alcohol consumption on emotion recognition in high and low trait aggressive drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption impairs processing of emotional faces. As emotion processing plays a key role in effective social interaction, these impairments may be one mechanism by which alcohol changes social behaviour. This study investigated the effect of individual differences on this relationship by comparing emotion recognition performance after acute alcohol consumption in individuals with high and low trait aggression.
METHODS


Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive). Participants attended two sessions. In one they consumed an alcoholic drink (0.4 g/kg) and in the other they consumed a matched placebo. They then completed two computer-based tasks: one measured global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad).
RESULTS


There was evidence of poorer global emotion recognition after alcohol. In addition, there was evidence of poorer sensitivity to sadness and fear after alcohol. There was also evidence for a reduced bias towards happiness following alcohol and weak evidence for an increased bias towards sadness.
CONCLUSIONS


These findings suggest that alcohol impairs global emotion recognition. They also highlight a reduced ability to detect sadness and fearful facial expressions. As sadness and fear are cues of submission and distress (i.e. function to curtail aggression), failure to successfully detect these emotions when intoxicated may increase the likelihood of aggressive responding. This coupled with a reduced bias towards seeing happiness may collectively contribute to aggressive behaviour.",2020,There was evidence of poorer global emotion recognition after alcohol.,"['individuals with high and low trait aggression', 'Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive', 'high and low trait aggressive drinkers']","['acute alcohol consumption', 'alcoholic drink', 'placebo']","['poorer global emotion recognition', 'global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad', 'global emotion recognition', 'emotion recognition', 'emotion recognition performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",,0.189109,There was evidence of poorer global emotion recognition after alcohol.,"[{'ForeName': 'Andrew Pr', 'Initials': 'AP', 'LastName': 'Eastwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922951']
2585,32466729,"Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE.","Background Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events. Methods and Results A multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation. Conclusions The ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02697916.",2020,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","['Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019', '650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks', 'adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria']","['Aspirin', 'aspirin']",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],15076.0,0.152651,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","[{'ForeName': 'Faraz S', 'Initials': 'FS', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (F.S.A.).'}, {'ForeName': 'Iben M', 'Initials': 'IM', 'LastName': 'Ricket', 'Affiliation': 'Louisiana Public Health Institute, New Orleans (I.M.R.).'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eskenazi', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Robertson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Lesley H', 'Initials': 'LH', 'LastName': 'Curtis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Cecilia D', 'Initials': 'CD', 'LastName': 'Dobi', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA (C.D.D.).'}, {'ForeName': 'Saket', 'Initials': 'S', 'LastName': 'Girotra', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City (S.G.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'Scientific Affairs, HealthCore, Inc., Wilmington, DE (K.H.).'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': 'Cardiology Section, San Francisco Veterans Affairs Health Care System, CA (J.R.K.).'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Mathew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Waitman', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS (R.W.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York Presbyterian-Weill Cornell Campus, New York (M.G.W.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006292']
2586,32466746,Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial.,"BACKGROUND


It is unclear whether regional anesthesia with infraclavicular nerve block or general anesthesia provides better postoperative analgesia after distal radial fracture fixation, especially when combined with regular postoperative analgesic medications. The aim of this study was to compare the postoperative analgesic effects of regional versus general anesthesia.
METHODS


In this prospective, observer blinded, randomized controlled trial, 52 patients undergoing distal radial fracture fixation received either general anesthesia (n = 26) or regional anesthesia (infraclavicular nerve block, n = 26). Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status were evaluated after surgery.
RESULT


Regional anesthesia was associated with significantly lower pain scores both at rest and with movement on arrival to the post-anesthetic care unit; and at 1, 2, 24 and 48 h after surgery (p ≤ 0.001 at rest and with movement). Morphine consumption in the post-anesthetic care unit was significantly lower in the regional anesthesia group (p<0.001). There were no differences in oral analgesic consumption. Regional anesthesia was associated with lower incidences of nausea (p = 0.004), and vomiting (p = 0.050). Patient satisfaction was higher in the regional anesthesia group (p = 0.003). There were no long-term differences in pain scores and other patient outcomes.
CONCLUSION


Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
TRIAL REGISTRATION


Before subject enrollment, the study was registered at ClinicalTrials.gov (NCT03048214) on 9th February 2017.",2020,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
","['after distal radial fracture fixation', '52 patients undergoing distal radial fracture fixation received either']","['Regional anesthesia with ultrasound guided infraclavicular nerve block', 'general anesthesia (n\u2009=\u200926) or regional anesthesia (infraclavicular nerve block, n\u2009=\u200926', 'Infraclavicular nerve block']","['Patient satisfaction', 'pain scores', 'postoperative pain', 'Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status', 'vomiting', 'acute pain relief', 'oral analgesic consumption', 'Morphine consumption', 'nausea', 'postoperative analgesic effects']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",52.0,0.47479,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
","[{'ForeName': 'Stanley S', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China. wongstan@hku.hk.'}, {'ForeName': 'Wing S', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesiology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Lau', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Leung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01044-4']
2587,32466773,The effects of combined magnesium and zinc supplementation on metabolic status in patients with type 2 diabetes mellitus and coronary heart disease.,"BACKGROUND


The present research aimed to analyze the impacts of magnesium and zinc supplements on glycemic control, serum lipids, and biomarkers of oxidative stress and inflammation in patients suffering from coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM).
METHODS


According to the research design, a randomized, double-blind, placebo-controlled trial has been implemented on 60 subjects suffering from CHD and T2DM. Therefore, participants have been randomly divided into 2 groups for taking placebo (n = 30) or 250 mg magnesium oxide plus 150 mg zinc sulfate (n = 30) for 12 weeks.
RESULTS


Magnesium and zinc significantly decreased fasting plasma glucose (FPG) (β - 9.44 mg/dL, 95% CI, - 18.30, - 0.57; P = 0.03) and insulin levels (β - 1.37 μIU/mL, 95% CI, - 2.57, - 0.18; P = 0.02). Moreover, HDL-cholesterol levels significantly enhanced (β 2.09 mg/dL, 95% CI, 0.05, 4.13; P = 0.04) in comparison to the placebo. There was an association between magnesium and zinc intake, and a significant decrease of C-reactive protein (CRP) (β - 0.85 mg/L, 95% CI, - 1.26, - 0.45; P < 0.001), a significant increase in total nitrite (β 5.13 μmol/L, 95% CI, 1.85, 8.41; P = 0.003) and total antioxidant capacity (TAC) (β 43.44 mmol/L, 95% CI, 3.39, 83.50; P = 0.03) when compared with placebo. Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo.
CONCLUSIONS


In patients with T2DM and CHD, the 12-week intake of magnesium plus zinc had beneficial effects on FPG, HDL-cholesterol, CRP, insulin, total nitrite, TAC levels, and BDI and BAI score. This suggests that magnesium and zinc co-supplementation may be beneficial for patients with T2DM and CHD. Further studies on more patients and lasting longer are needed to determine the safety of magnesium and zinc co-supplementation.
TRIAL REGISTRATION


Current Controlled Trials http://www.irct.ir: IRCT20130211012438N31 at 11 May 2019 of registration. This study retrospectively registered.",2020,"Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo.
","['patients with T2DM and CHD', '60 subjects suffering from CHD and T2DM', 'patients suffering from coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes mellitus and coronary heart disease']","['magnesium and zinc co-supplementation', 'magnesium plus zinc', 'magnesium and zinc supplements', 'magnesium oxide plus 150\u2009mg zinc sulfate', 'combined magnesium and zinc supplementation', 'placebo']","['Beck Anxiety Inventory (BAI', 'total nitrite', 'C-reactive protein (CRP', 'fasting plasma glucose (FPG', 'total antioxidant capacity (TAC', 'metabolic status', 'Beck Depression Inventory index (BDI', 'FPG, HDL-cholesterol, CRP, insulin, total nitrite, TAC levels, and BDI and BAI score', 'glycemic control, serum lipids, and biomarkers of oxidative stress and inflammation', 'HDL-cholesterol levels', 'insulin levels', 'magnesium and zinc intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}]",60.0,0.535227,"Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hamedifard', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farrokhian', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'Department of Internal Medicine, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghotbi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran. taghizadeh.mohsen22@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01298-4']
2588,32466811,"Mentalization-based treatment for psychotic disorder: a rater-blinded, multi-center, randomized controlled trial.","BACKGROUND


Impaired mentalizing ability - an impaired ability to understand one's own and other people's behavior in terms of mental states - is associated with social dysfunction in non-affective psychotic disorder (NAPD). We tested whether adding mentalization-based treatment for psychotic disorder (MBTp) to treatment as usual (TAU) results in greater improvement in social functioning.
METHODS


Multicenter, rater-blinded, randomized controlled trial. Eighty-four patients with NAPD were assigned to TAU or MBTp plus TAU. Patients in the MBTp group received 18 months of MBTp, consisting of weekly group sessions and one individual session per 2 weeks. Social functioning was measured using the Social Functioning Scale. We conducted ANCOVAs to examine the difference between treatment conditions directly after treatment and at 6-month follow-up and performed moderation and mediation analyses.
RESULTS


Intention-to-treat analyses showed no significant differences between groups post-treatment (p = 0.31) but revealed the MBTp group to be superior to TAU at follow-up (p = 0.03). Patients in the MBTp group also seemed to perform better on measures of mentalizing ability, although evidence of a mediation effect was limited (p = 0.06). Lastly, MBTp treatment was less effective in chronic patients than in recent-onset patients (p = 0.049) and overall symptoms at baseline were mild, which may have reduced the overall effectiveness of the intervention.
CONCLUSION


The results suggest that MBTp plus TAU may lead to more robust improvements in social functioning compared to TAU, especially for patients with a recent onset of psychosis.",2020,"RESULTS


Intention-to-treat analyses showed no significant differences between groups post-treatment (p = 0.31) but revealed the MBTp group to be superior to TAU at follow-up (p = 0.03).","['psychotic disorder', 'Eighty-four patients with NAPD']","['MBTp', 'MBTp plus TAU', 'Mentalization-based treatment', 'TAU or MBTp plus TAU']","['Social Functioning Scale', 'overall symptoms', 'Social functioning', 'social functioning', 'mentalizing ability']","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2585826', 'cui_str': 'Social functioning scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",84.0,0.151779,"RESULTS


Intention-to-treat analyses showed no significant differences between groups post-treatment (p = 0.31) but revealed the MBTp group to be superior to TAU at follow-up (p = 0.03).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weijers', 'Affiliation': 'Rivierduinen Institute for Mental Health Care, Sandifortdreef 19, 2333 ZZ Leiden, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ten Kate', 'Affiliation': 'Rivierduinen Institute for Mental Health Care, Sandifortdreef 19, 2333 ZZ Leiden, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Viechtbauer', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 50, 6229 ER Maastricht, The Netherlands.'}, {'ForeName': 'L J A', 'Initials': 'LJA', 'LastName': 'Rampaart', 'Affiliation': 'Rivierduinen Institute for Mental Health Care, Sandifortdreef 19, 2333 ZZ Leiden, The Netherlands.'}, {'ForeName': 'E H M', 'Initials': 'EHM', 'LastName': 'Eurelings', 'Affiliation': 'Department of Clinical Psychology, Health, and Neuropsychology, Leiden University, Wassenaarseweg 52, 2333 AKLeiden, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Selten', 'Affiliation': 'Rivierduinen Institute for Mental Health Care, Sandifortdreef 19, 2333 ZZ Leiden, The Netherlands.'}]",Psychological medicine,['10.1017/S0033291720001506']
2589,32466836,Use of the Win Ratio in Cardiovascular Trials.,"OBJECTIVES


The purpose of this study was to compare the win ratio (WR) with the corresponding hazard ratios (HRs) and 1/HR.
BACKGROUND


The primary outcome in many cardiovascular trials is a composite that includes nonfatal and fatal events. The time-to-first event analysis gives equal statistical weighting to each component event. The WR, which takes into account the clinical importance and timing of the outcomes, has been suggested as an alternative approach.
METHODS


Cox proportional hazards models and WR.
RESULTS


In the these trials (n = 16) the WR and HR differed only slightly. For example, in the PARADIGM-HF (sacubitril/valsartan vs. enalapril), the primary outcome of time to first heart failure hospitalization (HFH) or cardiovascular death (CVD) and use of the Cox model gave a 1/HR of 1.25 (95% confidence interval [CI]: 1.12 to 1. 41; z-score = 4.8). Using WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.27 (95% CI: 1.15 to 1.39; z-score = 4.7), reflecting an effect similar to that of sacubitril/valsartan therapy on CVD and HFH. In the DIG (digoxin vs. placebo) trial, the outcome of time-to-first HFH or CVD using Cox gave a 1/HR of 1.18 (95% CI: 1.10 to 1.27; z-score = 4.5). Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD. Several other trials and endpoints including patient-reported measurements were studied.
CONCLUSIONS


In 16 large cardiovascular outcome trials, HR and WR provided similar estimates of treatment effects. The WR allows prioritization of fatal outcomes and the hierarchical testing of broader composite endpoints including patient-reported outcomes. In this way, the WR allows for the incorporation of patient-centered and other outcomes, while prioritizing the competing risk of death and hospital admission.",2020,"Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD.",[],"['valsartan vs. enalapril', 'DIG (digoxin vs. placebo', 'digoxin']","['win ratio (WR) with the corresponding hazard ratios (HRs) and 1/HR', 'time to first heart failure hospitalization (HFH) or cardiovascular death (CVD', 'nonfatal and fatal events']",[],"[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1321878', 'cui_str': 'Desmoplastic infantile ganglioglioma'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.173785,"Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Duarte', 'Affiliation': 'National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France; Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.02.010']
2590,32466854,Preoperative Vitamin D Supplementation in Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy.,"BACKGROUND


Transient hypocalcemia due to parathyroid gland or vessel manipulation is a common complication following thyroidectomy. Considering the role of 25-hydroxyvitamin D (25(OH)D) in calcium hemostasis, this study aimed to evaluate the effect of preoperative vitamin D supplementation on hypocalcemia incidence in thyroidectomy patients.
METHODS


In this randomized clinical trial, 100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled. Patients were randomly allocated to either study or control groups using the sealed envelope method. Patients in the study group received vitamin D3 50,000-unit pearl weekly for 4 weeks prior to the operation. The control group received placebo. Total and ionized serum calcium levels were checked before surgery, the day after surgery, and 2 weeks postoperatively.
RESULTS


No significant difference was observed in terms of demographic data. During serial total calcium checks (5 episodes), total calcium levels changed significantly in patients who had received vitamin D supplements compared to the control group (P = 0.043). Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D) (P = 0.04). Also, the requirement for intravenous calcium administration in order to treat the hypocalcemia symptoms was significantly lower in the study in comparison to the control group (P = 0.03).
CONCLUSIONS


Vitamin D supplementation in patients with vitamin D deficiency might lead to a lower incidence of early-onset symptomatic hypocalcemia; hence, requiring less calcium supplementation for the management of hypocalcemia.",2020,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"['100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled', 'thyroidectomy patients', 'Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy', 'patients with vitamin D deficiency']","['vitamin D supplements', 'preoperative vitamin D supplementation', 'Vitamin D supplementation', '25-hydroxyvitamin D (25(OH)D', 'Preoperative Vitamin D Supplementation', 'vitamin D3', 'placebo']","['Total and ionized serum calcium levels', 'demographic data', 'Symptomatic hypocalcemia incidence', 'total calcium levels', 'hypocalcemia symptoms', 'hypocalcemia incidence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0588547,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramouz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Mahdie', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Cardiothoracic Surgery, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyedeh Shaghayegh', 'Initials': 'SS', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Ziaeddin', 'Initials': 'SZ', 'LastName': 'Rasihashemi', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: zia.hashemi@yahoo.com.'}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.04.036']
2591,32466858,Lipid deposition on contact lenses in symptomatic and asymptomatic contact lens wearers.,"PURPOSE


Lipid deposition on contact lenses (CL) has traditionally been believed to reduce comfort during CL wear. The purpose of this study was to quantify lipid deposition on CL in a group of symptomatic and asymptomatic adapted CL wearers.
METHODS


This was a single-masked, randomized clinical trial. Only confirmed symptomatic (comfortable lens wear time (CWT) < 8 h and a noticeable reduction in comfort over the course of the day) and asymptomatic (CWT > 10 h and minimal reduction in comfort over the course of the day) participants were recruited to participate in the study. Participants wore senofilcon A lenses in combination with a polyquaternium-based care solution (OPTI-FREE Replenish). Worn CL samples were collected on Day 14. Deposited lipid amounts from the lenses (including cholesteryl ester, cholesterol and triolein) were quantified using a liquid chromatography-mass spectrometry technique.
RESULTS


Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log μg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log μg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log μg/lens) (all p < 0.002). The amount of cholesteryl ester deposited was greatest (p = 0.0001), followed by cholesterol, then triolein, for both the asymptomatic and symptomatic groups (both p = 0.0001).
CONCLUSION


This study demonstrated that the asymptomatic group deposited a significantly greater amount of lipid on their CL. Although lipid levels measured are considered low to trigger any observable clinical deposition, they may influence other clinical outcomes, particularly comfort.",2020,"RESULTS


Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log μg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log μg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log μg/lens) (all p < 0.002).","['symptomatic and asymptomatic contact lens wearers', 'group of symptomatic and asymptomatic adapted CL wearers', 'contact lenses (CL']","['Lipid deposition', 'senofilcon A lenses in combination with a polyquaternium-based care solution (OPTI-FREE Replenish']","['Lipid deposition', 'symptomatic (comfortable lens wear time (CWT', 'lipid deposition', 'amount of cholesteryl ester']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}]",,0.0577619,"RESULTS


Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log μg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log μg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log μg/lens) (all p < 0.002).","[{'ForeName': 'Negar Babaei', 'Initials': 'NB', 'LastName': 'Omali', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Canada.'}, {'ForeName': 'Lakshman N', 'Initials': 'LN', 'LastName': 'Subbaraman', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Canada.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Heynen', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lada', 'Affiliation': 'Johnson and Johnson Vision, Jacksonville, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Canavan', 'Affiliation': 'Johnson and Johnson Vision, Jacksonville, USA.'}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Fadli', 'Affiliation': 'Johnson and Johnson Vision, Jacksonville, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ngo', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Canada. Electronic address: wngo@uwaterloo.ca.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Canada.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.05.006']
2592,32466879,Evaluation of Mavacamten in Symptomatic Patients With Nonobstructive Hypertrophic Cardiomyopathy.,"BACKGROUND


Patients with nonobstructive hypertrophic cardiomyopathy (nHCM) often experience a high burden of symptoms; however, there are no proven pharmacological therapies. By altering the contractile mechanics of the cardiomyocyte, myosin inhibitors have the potential to modify pathophysiology and improve symptoms associated with HCM.
OBJECTIVES


MAVERICK-HCM (Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy) explored the safety and efficacy of mavacamten, a first-in-class reversible inhibitor of cardiac-specific myosin, in nHCM.
METHODS


The MAVERICK-HCM trial was a multicenter, double-blind, placebo-controlled, dose-ranging phase II study in adults with symptomatic nHCM (New York Heart Association functional class II/III), left ventricular ejection fraction (LVEF) ≥55%, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml. Participants were randomized 1:1:1 to mavacamten at a pharmacokinetic-adjusted dose (targeting plasma levels of 200 or 500 ng/ml), or placebo for 16 weeks, followed by an 8-week washout. Initial dose was 5 mg daily with 1 dose titration at week 6.
RESULTS


Fifty-nine participants were randomized (19, 21, 19 patients to 200 ng/ml, 500 ng/ml, placebo, respectively). Their mean age was 54 years, and 58% were women. Serious adverse events occurred in 10% of participants on mavacamten and in 21% participants on placebo. Five participants on mavacamten had reversible reduction in LVEF ≤45%. NT-proBNP geometric mean decreased by 53% in the pooled mavacamten group versus 1% in the placebo group, with geometric mean differences of -435 and -6 pg/ml, respectively (p = 0.0005). Cardiac troponin I (cTnI) geometric mean decreased by 34% in the pooled mavacamten group versus a 4% increase in the placebo group, with geometric mean differences of -0.008 and 0.001 ng/ml, respectively (p = 0.009).
CONCLUSIONS


Mavacamten, a novel myosin inhibitor, was well tolerated in most subjects with symptomatic nHCM. Furthermore, treatment was associated with a significant reduction in NT-proBNP and cTnI, suggesting improvement in myocardial wall stress. These results set the stage for future studies of mavacamten in this patient population using clinical parameters, including LVEF, to guide dosing. (A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy [MAVERICK-HCM]; NCT03442764).",2020,"Cardiac troponin I (cTnI) geometric mean decreased by 34% in the pooled mavacamten group versus a 4% increase in the placebo group, with geometric mean differences of -0.008 and 0.001 ng/ml, respectively (p = 0.009).
","['Symptomatic Patients With Nonobstructive Hypertrophic Cardiomyopathy', 'Patients with nonobstructive hypertrophic cardiomyopathy (nHCM', 'Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy', 'Fifty-nine participants', 'subjects with symptomatic nHCM', 'adults with symptomatic nHCM (New York Heart Association functional class II/III), left ventricular ejection fraction (LVEF)\xa0≥55%, and N-terminal pro-B-type natriuretic peptide (NT-proBNP)\xa0≥300 pg/ml', 'Adults\xa0With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy', 'Their mean age was 54 years, and 58% were women']","['placebo', 'mavacamten at a pharmacokinetic-adjusted dose (targeting plasma levels of 200 or 500\xa0ng/ml), or placebo', 'Mavacamten']","['NT-proBNP geometric mean', 'Cardiac troponin I (cTnI) geometric mean', 'myocardial wall stress', 'Serious adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340425', 'cui_str': 'Hypertrophic cardiomyopathy without obstruction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",59.0,0.444786,"Cardiac troponin I (cTnI) geometric mean decreased by 34% in the pooled mavacamten group versus a 4% increase in the placebo group, with geometric mean differences of -0.008 and 0.001 ng/ml, respectively (p = 0.009).
","[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: cho@bwh.harvard.edu.""}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Mealiffe', 'Affiliation': 'MyoKardia, Inc., Brisbane, California.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Mondira', 'Initials': 'M', 'LastName': 'Bhattacharya', 'Affiliation': 'MyoKardia, Inc., Brisbane, California.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Choudhury', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, Illinois.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Inc., Brisbane, California.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Hegde', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Diseases, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Arizona, Phoenix, Arizona.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'MyoKardia, Inc., Brisbane, California.'}, {'ForeName': 'Ali J', 'Initials': 'AJ', 'LastName': 'Marian', 'Affiliation': 'Center for Cardiovascular Genetics, Institute of Molecular Medicine, University of Texas Health Sciences Center at Houston, Houston, Texas.'}, {'ForeName': 'Sherif F', 'Initials': 'SF', 'LastName': 'Nagueh', 'Affiliation': 'Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Owens', 'Affiliation': 'Heart and Vascular Center, Perelman Center for Advanced Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rader', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Inc., Brisbane, California.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Sherrid', 'Affiliation': 'Hypertrophic Cardiomyopathy Program, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Diseases, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke Cardiology, Duke Health Center at Southpoint, Durham, North Carolina.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Wever-Pinzon', 'Affiliation': 'Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.064']
2593,32466881,Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis.,"BACKGROUND


In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES).
OBJECTIVES


This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR.
METHODS


The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses.
RESULTS


A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types.
CONCLUSIONS


At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.",2020,"Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.","['patients with coronary in-stent restenosis (ISR) requiring reintervention', 'patients with BMS-and DES-ISR', '710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included', 'Patients With Coronary Stent Restenosis']","['DCB angioplasty and repeat stenting with DES', 'angioplasty with drug-coated balloon (DCB) and repeat stenting DES ', 'Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation', 'Drug-Eluting Stent and Drug-Coated Balloon Angioplasty', 'DCB angioplasty with repeat DES implantation', 'DCB angioplasty']","['target lesion revascularization (TLR', 'nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses', 'safety endpoints', 'composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years', 'comparative efficacy and safety', 'primary efficacy', 'risk of TLR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}]","[{'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0000938', 'cui_str': 'Accounting'}, {'cui': 'C0577305', 'cui_str': 'Multiple lesions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",710.0,0.124107,"Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Giacoppo', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: giacoppo@dhm.mhn.de.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Mount Sinai Heart, The Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Adriaenssens', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Pérez-Vizcayno', 'Affiliation': 'Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Degenhardt', 'Affiliation': 'Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany.'}, {'ForeName': 'Leos', 'Initials': 'L', 'LastName': 'Pleva', 'Affiliation': 'Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': 'Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kukla', 'Affiliation': 'Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jiménez-Quevedo', 'Affiliation': 'Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Unverdorben', 'Affiliation': 'Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany; Daiichi-Sankyo, Basking Ridge, New Jersey.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Christoph K', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Dublin Cardiovascular Research Institute, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.006']
2594,32466912,The impact of calorie and physical activity labelling on consumer's emo-sensory perceptions and food choices.,"Providing labelling information is one of the strategies used to help consumers make healthier choices. However, although the type of information has the potential to assist consumers, it is important to evaluate their sensory and emotional perceptions. Therefore, the objective of this study was to evaluate the effect of different labelling information on consumers' sensory and emotional perceptions and their choices, for three different products (potato chips, juice and yogurt). A total of 480 participants were randomly assigned to one of four information conditions (no information (blind), kilocalorie (kcal) information, physical activity (PA) information [duration of walking required to burn the kcal in the product], kcal + PA information). For each information condition, participants were provided with higher kcal and lower kcal equivalent food pairs and were required to choose one. The participants evaluated their overall liking using a 9-point hedonic scale and answered rate-all-that-apply (RATA) questions related to the sensory and emotional characteristics of the products. The results showed no significant impact of calorie and physical activity labelling on consumers' overall liking for juice and yogurt samples and no impact of PA information for chips. Significant differences in overall liking were found when comparing the blind condition with kcal and kcal + PA information, with lower acceptance of the chips samples when this information was presented. Although providing calorie and physical activity labelling had little impact on consumers' sensory and emotional perceptions, consumers perceived unhealthy attributes and negative emotions, such as fatty and guilty, when information was presented. The present work suggests that, although nutrition labelling may be presented as an important strategy to assist consumers, it is important to evaluate consumers' lifestyles, considering that non-dieters and those low and moderate in dietary restraint may not be impacted by this information.",2020,The results showed no significant impact of calorie and physical activity labelling on consumers' overall liking for juice and yogurt samples and no impact of PA information for chips.,['A total of 480 participants'],"['calorie and physical activity labelling', 'four information conditions (no information (blind), kilocalorie (kcal) information, physical activity (PA) information [duration of walking required to burn the kcal in the product], kcal\xa0+\xa0PA information']","['overall liking using a 9-point hedonic scale and answered rate-all-that-apply (RATA) questions', 'calorie and physical activity labelling', 'overall liking']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",480.0,0.0405149,The results showed no significant impact of calorie and physical activity labelling on consumers' overall liking for juice and yogurt samples and no impact of PA information for chips.,"[{'ForeName': 'Denize', 'Initials': 'D', 'LastName': 'Oliveira', 'Affiliation': 'Department of Agricultural Economics, Ghent University, Coupure Links 653, 9000 Gent, Belgium. Electronic address: Denize.RodriguesDeOliveira@UGent.be.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'De Steur', 'Affiliation': 'Department of Agricultural Economics, Ghent University, Coupure Links 653, 9000 Gent, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lagast', 'Affiliation': 'Department of Agricultural Economics, Ghent University, Coupure Links 653, 9000 Gent, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gellynck', 'Affiliation': 'Department of Agricultural Economics, Ghent University, Coupure Links 653, 9000 Gent, Belgium.'}, {'ForeName': 'Joachim J', 'Initials': 'JJ', 'LastName': 'Schouteten', 'Affiliation': 'Department of Agricultural Economics, Ghent University, Coupure Links 653, 9000 Gent, Belgium.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2020.109166']
2595,32466961,Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC.,"PURPOSE


The present study compared the efficacy of sunitinib and sorafenib as first-line treatment of metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk.
PATIENTS AND METHODS


Treatment-naive patients with mCC-RCC were randomized to receive open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU). The primary endpoint was first-line progression-free survival (PFS). The secondary endpoints were total PFS and overall survival (OS).
RESULTS


Of the 124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated. The median first-line PFS duration was 8.7 and 7.0 months in the SU/SO and SO/SU groups, respectively (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.42-1.08). The total PFS and OS were not significantly different between the SU/SO and SO/SU groups (27.8 and 22.6 months; HR, 0.73; 95% CI, 0.428-1.246; and 38.4 and 30.9 months; HR, 0.934; 95% CI, 0.588-1.485, respectively). The subgroup analysis revealed that the total PFS with SU/SO was superior to the total PFS with SO/SU in the patients with favorable MSKCC risk and those with < 5 metastatic sites). SO/SU was superior to SU/SO for patients without previous nephrectomy.
CONCLUSIONS


No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).",2020,"No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).","['Treatment-naive patients with mCC-RCC', 'mCC-RCC With Favorable/Intermediate Risk', 'metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk', 'patients without previous nephrectomy', '124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated']","['open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU', 'sunitinib and sorafenib', 'Sunitinib Versus Sorafenib']","['total PFS and overall survival (OS', 'median first-line PFS duration', 'first-line progression-free survival (PFS', 'first-line PFS, total PFS, or OS', 'total PFS and OS']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",124.0,0.0953987,"No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ytomita@med.niigata-u.ac.jp.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Sassa', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Hakodate Goryoukaku Hospital, Hokkaido, Japan.'}, {'ForeName': 'Tsunenori', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Koie', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan; Department of Urology, Gifu University School of Medicine, Seki, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Obara', 'Affiliation': 'Department of Urology, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Teishima', 'Affiliation': 'Department of Urology, Graduate School of Biomedical Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hideyasu', 'Initials': 'H', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Urology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kishida', 'Affiliation': 'Department of Urology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Shiroki', 'Affiliation': 'Department of Urology, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Saika', 'Affiliation': 'Department of Urology, Ehime University, Matsuyama, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Shinohara', 'Affiliation': 'Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiro-Omi', 'Initials': 'HO', 'LastName': 'Kanayama', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.01.001']
2596,32467034,Evaluation of nebulized N-acetyl cysteine in outcome of esophageal atresia with tracheoesophegeal fistula.,"AIM


To evaluate the role of nebulized N-acetyl cysteine (NAC) in liquefying the airway secretions and improving the outcome of patients of esophageal atresia with tracheoesophageal fistula (EA + TEF).
METHODS


It was a non-randomized interventional study. Two milliliters of 10% NAC was given in a nebulized form (2:5 dilution, every six hourly) to patients of ET + TEF, along with regular suction of upper esophageal pouch. The group was compared with control, which comprised patients of EA + TEF receiving only saline nebulization. The consistency of the secretions was compared by hand held consistometer in unit of time (seconds) required to cross a predetermined distance along with gravity.
RESULTS


Sixty patients were assessed. Of these, 30 patients were present in both groups. The study group showed significant (p = 0.01-0.0001) decrease in consistency of secretions from the control group after day 2 of NAC nebulization. Patients' discharge was significantly (p = 0.01) earlier in cases. There was no significant (p = 0.41) difference in mortality between the groups. No specific adverse effects were observed in the study group.
CONCLUSION


It appears that nebulized NAC decreases the consistency of secretions in EA + TEF patients. It is interesting to note that the group of patients that received NAC was discharged earlier than the control group and had a higher survival rate than the control group. Whether this is directly attributable to the use of NAC is unknown. A prospective double-blinded randomized clinical trial is warranted to confirm these results.
LEVEL OF EVIDENCE


Level II, prospective comparative study (non-randomized).",2020,The study group showed significant (p = 0.01-0.0001) decrease in consistency of secretions from the control group after day 2 of NAC nebulization.,"['Sixty patients were assessed', 'patients of esophageal atresia with tracheoesophageal fistula (EA\u202f+\u202fTEF', '30 patients were present in both groups', 'esophageal atresia with tracheoesophegeal fistula']","['NAC', 'nebulized NAC', 'nebulized N-acetyl cysteine', 'nebulized N-acetyl cysteine (NAC']","['survival rate', 'specific adverse effects', 'mortality', 'consistency of secretions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341154', 'cui_str': 'Esophageal atresia with tracheo-esophageal fistula'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014850', 'cui_str': 'Congenital atresia of esophagus'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",60.0,0.0725299,The study group showed significant (p = 0.01-0.0001) decrease in consistency of secretions from the control group after day 2 of NAC nebulization.,"[{'ForeName': 'Gurmeet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India. Electronic address: dranand27@rediffmail.com.""}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Shandilya', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}, {'ForeName': 'Archika', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Rawat', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Wakhlu', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Kureel', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow 226003, UP, India.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.04.013']
2597,32467037,Totally implantable venous access ports: A prospective randomized study comparing subclavian and internal jugular vein punctures in children.,"BACKGROUND AND OBJECTIVES


Totally implantable venous access ports (TIVAPs) are essential in children who require long-term intermittent intravenous therapy.
METHODS


Patients who needed to undergo TIVAP implantation were randomly assigned to the internal jugular vein group or the subclavian vein group. The medical histories, operative details and major complications from the time of port implantation to 48 h after port removal were collected. During the use of TIVAPs, satisfaction surveys were regularly conducted for the children and guardians and compared in the two groups.
RESULTS


A total of 216 patients in the subclavian vein group and 199 patients in the internal jugular vein group were included. TIVAPs were successfully implanted in all children. The incidence of postoperative venous access occlusion in the subclavian vein group and internal jugular vein group was 1.5% and 5%, respectively, and the difference was statistically significant (P < 0.05). The average satisfaction score of the children and guardians in the subclavian vein group was 9.6 ± 0.3, and that in the internal jugular vein group was 8.3 ± 0.8. There was a significant difference between the 2 groups (P < 0.05).
CONCLUSIONS


Subclavian vein should be the first choice for TIVAP implantation in children.
THE LEVEL OF EVIDENCE RATING


Treatment study level I.",2020,"The incidence of postoperative venous access occlusion in the subclavian vein group and internal jugular vein group was 1.5% and 5%, respectively, and the difference was statistically significant (P < 0.05).","['children who require long-term intermittent intravenous therapy', '216 patients in the subclavian vein group and 199 patients in the internal jugular vein group were included', 'Patients who needed to undergo TIVAP implantation', 'children']","['subclavian and internal jugular vein punctures', 'internal jugular vein group or the subclavian vein group']","['average satisfaction score', 'TIVAPs', 'incidence of postoperative venous access occlusion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0589488', 'cui_str': 'Subclavicular approach'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1275732', 'cui_str': 'Implantable venous access port'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",216.0,0.0239542,"The incidence of postoperative venous access occlusion in the subclavian vein group and internal jugular vein group was 1.5% and 5%, respectively, and the difference was statistically significant (P < 0.05).","[{'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics. Electronic address: surgjun@gmail.com.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'XiangRu', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Kou', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'LinYa', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'ChangChun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}, {'ForeName': 'GuangHui', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': ""Department of Surgical Oncology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, P, .R, China; Chongqing Key Laboratory of Pediatrics.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.04.021']
2598,32467054,Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial.,"OBJECTIVE


In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence.
METHODS


ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery).
RESULTS


Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups.
CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.",2020,"CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","['Patients were recruited between 2010 and 2015', 'patients with gynecologic cancer requiring minimally invasive surgery', 'gynecologic oncology', 'patients with gynecologic cancer', '369 of 385 patients were included in the as-treated analysis']","['conventional laparoscopy (CL', 'RL and CL', 'robot-assisted laparoscopy (RL', 'robot-assisted versus conventional laparoscopy', 'RL']","['Severe perioperative morbidity', 'median operating time for RL', 'severe perioperative morbidity (severe complications', 'overall and disease-free survival', 'severe perioperative morbidity', 'severe morbidity', 'overall rates of conversion to open surgery', 'blood loss volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",385.0,0.185524,"CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Narducci', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France. Electronic address: f-narducci@o-lambret.fr.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hebert', 'Affiliation': 'Tours University Hospital, Tours, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Limoges University Hospital, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Collinet', 'Affiliation': 'Lille University Hospital, Lille, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Classe', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lecuru', 'Affiliation': 'Georges-Pompidou University Hospital, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delest', 'Affiliation': 'Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Motton', 'Affiliation': 'Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Conri', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ferrer', 'Affiliation': 'Nimes University Hospital, Nimes, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'CRAN, UMR 7039, Université de Lorraine, CNRS Institut de Cancérologie de Lorraine Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Institut Claudius Regaud Cancer Center, Toulouse, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Probst', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Thery', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France; Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Lefebvre', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Francon', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leblanc', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lambaudie', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.010']
2599,32467089,Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation.,"OBJECTIVE


Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD).
DESIGN


We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement.
RESULTS


Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement.
CONCLUSIONS


Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD.
TRAIL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02505945.",2020,"Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis.","['regurgitation predominant gastro-oesophageal reflux disease (GERD', 'Of 152 randomised patients, 123 (age 46.9±1.2\u2009year', 'adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI', 'gastro-oesophageal reflux disease (GERD) patients with regurgitation']",['PPI or magnetic sphincter augmentation (MSA'],"['Foregut Symptom Questionnaire (FSQ) regurgitation score', 'regurgitation score', 'reflux episodes', 'GERD health-related quality of life (HRQL) score and satisfaction with therapy', 'Symptom and satisfaction scores', 'FSQ regurgitation score, GERD HRQL score and satisfaction', 'symptom response']","[{'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",152.0,0.0937446,"Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis.","[{'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Rogers', 'Affiliation': 'Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Luis R', 'Initials': 'LR', 'LastName': 'Valdovinos', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Crowell', 'Affiliation': 'Gastroenterology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Institute of Esophageal and Reflux Surgery, Englewood, Colorado, USA.'}, {'ForeName': 'Marcelo F', 'Initials': 'MF', 'LastName': 'Vela', 'Affiliation': 'Gastroenterology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.'}, {'ForeName': 'C Prakash', 'Initials': 'CP', 'LastName': 'Gyawali', 'Affiliation': 'Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA cprakash@wustl.edu.'}]",Gut,['10.1136/gutjnl-2020-321395']
2600,32467099,LKB1  mutations are not associated with the efficacy of first-line and second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC): a post hoc analysis of the TAILOR trial.,"PURPOSE


In patients with advanced lung adenocarcinoma, the impact of  LKB1  mutations on cytotoxic chemotherapy efficacy remains poorly explored. Here, we aimed at investigating the potential impact of  LKB1  mutational status on chemotherapy efficacy in advanced non-small-cell lung cancer (NSCLC) patients enrolled in the TArceva Italian Lung Optimisation tRial (TAILOR) trial.
METHODS


The multicenter TAILOR trial randomised patients with  EGFR -wild type (wt) advanced NSCLC progressing on/after previous platinum-based chemotherapy to receive docetaxel or erlotinib. Here, we evaluated the impact of  LKB1  mutational status on progression-free survival (PFS) and overall survival (OS) in patients treated with second-line docetaxel/erlotinib or during prior platinum-based chemotherapy.
RESULTS


Out of 222 patients randomised in the TAILOR trial, left-over tumour tissues were available for 188 patients, and 120 patients with evaluable  LKB1  status were included. Of them, 17 (14.17%) patients had  LKB1 -mutated tumours, while 103 (85.83%) had  LKB1- wt disease. During second-line treatment, PFS and OS were not statistically significantly different in patients with  LKB1- mutated when compared with  LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively). Similarly, we found no significant association between  LKB1  mutations and patient PFS or OS during prior first-line platinum-based chemotherapy (aHR=1.04, 95% CI 0.55 to 1.97; p=0.910 and aHR=0.83, 95% CI 0.42 to 1.65; p=0.602, respectively).
CONCLUSION


Among advanced NSCLC patients receiving two lines of systemic therapy,  LKB1  mutations were not associated with PFS or OS during second-line docetaxel or prior first-line platinum-based chemotherapy. While larger prospective trials are needed to confirm our findings, cytotoxic chemotherapy remains the backbone of investigational combination strategies in this patient population.",2020,"During second-line treatment, PFS and OS were not statistically significantly different in patients with  LKB1- mutated when compared with  LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively).","['advanced NSCLC patients receiving two lines of systemic therapy', 'patients with  EGFR -wild type (wt) advanced NSCLC progressing on/after previous platinum-based chemotherapy to receive', 'patients with advanced lung adenocarcinoma', '222 patients randomised in the TAILOR trial, left-over tumour tissues were available for 188 patients, and 120 patients with evaluable  LKB1  status were included', 'patients with advanced non-small-cell lung cancer (NSCLC', 'advanced non-small-cell lung cancer (NSCLC) patients enrolled in the TArceva Italian Lung Optimisation tRial (TAILOR) trial', 'patients treated with second-line docetaxel/erlotinib or during prior platinum-based chemotherapy']",['docetaxel or erlotinib'],"['LKB1  mutations and patient PFS or OS', 'PFS and OS', 'chemotherapy efficacy', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1431123', 'cui_str': 'STK11 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1135136', 'cui_str': 'Tarceva'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C1431123', 'cui_str': 'STK11 protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",222.0,0.125564,"During second-line treatment, PFS and OS were not statistically significantly different in patients with  LKB1- mutated when compared with  LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vernieri', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy claudio.vernieri@istitutotumori.mi.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ganzinelli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'Department of Oncology, ASST Fatebenefratelli Sacco, Milano, Lombardia, Italy.'}, {'ForeName': 'Anna Cecilia', 'Initials': 'AC', 'LastName': 'Bettini', 'Affiliation': 'Oncology Department, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bareggi', 'Affiliation': ""Oncology Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy.""}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rosso', 'Affiliation': ""Thoracic Surgery and Lung Transplant Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy.""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Signorelli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Galli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lo Russo', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Proto', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Moro', 'Affiliation': 'Tumor Genomics Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Indraccolo', 'Affiliation': 'Immunology and Molecular Oncology Unit, Istituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Veneto, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumor Genomics Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Marabese', 'Affiliation': 'Laboratory of Molecular Pharmacology, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Broggini', 'Initials': 'B', 'LastName': 'Massimo', 'Affiliation': 'Laboratory of Molecular Pharmacology, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1136/esmoopen-2020-000748']
2601,32467108,E-HeaRT BPA: electronic health record telemetry BPA.,"INTRODUCTION


Ccontinuous cardiac monitoring in non-critical care settings is expensive and overutilised. As such, it is an important target of hospital interventions to establish cost-effective, high-quality care. Since inappropriate telemetry use was persistently elevated at our institution, we devised an electronic best practice alert (BPA) and tested it in a randomised controlled fashion.
METHODS


Between 4 March 2018 and 5 July 2018 at our 600-bed academic hospital, all non-critical care patients who had at least one telemetry order were randomised to the control or intervention group. The intervention group received daily BPAs if telemetry was active.
RESULTS


275 and 283 patients were randomised to the intervention and control groups, respectively. The intervention group triggered 1042 alerts and trended toward fewer telemetry days (3.8 vs 5.0, p=0.017). The intervention group stopped telemetry 31.7% of the alerted patient-days compared with 23.3% for the control group (OR 1.53, 95% CI 1.24 to 1.88, p<0.001). There were no significant differences in length of stay, rapid responses, code blues, or mortality between the two groups.
CONCLUSIONS


Using a randomised controlled design, we show that BPAs significantly reduce telemetry without negatively affecting patient outcomes. They should have a role in promoting high-value telemetry use.",2020,"There were no significant differences in length of stay, rapid responses, code blues, or mortality between the two groups.
","['275 and 283 patients', 'all non-critical care patients who had at least one telemetry order', 'Between 4 March 2018 and 5 July 2018 at our 600-bed academic hospital']","['BPAs', 'daily BPAs if telemetry was active']","['length of stay, rapid responses, code blues, or mortality']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0150518', 'cui_str': 'Code Blue'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0970465,"There were no significant differences in length of stay, rapid responses, code blues, or mortality between the two groups.
","[{'ForeName': 'Kuo-Kai', 'Initials': 'KK', 'LastName': 'Chin', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Svec', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leung', 'Affiliation': 'Stanford Healthcare, Stanford, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sharp', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shieh', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA lshieh@stanford.edu.'}]",Postgraduate medical journal,['10.1136/postgradmedj-2019-137421']
2602,32467299,Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma.,"BACKGROUND


A pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) showed a higher than anticipated objective response rate (ORR) among patients with metastatic melanoma (MM). We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma.
METHODS


Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible. There was a 1:1 randomization to SBRT + IL-2 or IL-2 monotherapy. Patients received one or two doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting the first cycle of IL-2. IL-2 (600,000 IU per kg via intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Responding patients received up to six IL-2 cycles. Patients assigned to IL-2 monotherapy who exhibited progression of melanoma after cycle 2 were allowed to crossover and receive SBRT and additional IL-2. Response Evaluation Criteria in Solid Tumors 1.1 criteria were applied to non-irradiated lesions for response assessment.
RESULTS


44 patients were included in the analysis. The ORR in the SBRT + IL-2 group was 54%: 21% complete response (CR), 33% partial response (PR), 21% stable disease (SD) and 25% progressive disease (PD). The ORR in patients receiving IL-2 monotherapy was 35%: 15% CR, 20% PR, 25% SD and 40% PD. Seven patients assigned to IL-2 subsequently received SBRT + IL-2. One CR and two PRs were observed in the crossover group. There was no difference in progression-free or overall survival (OS). At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group. The disease control rate (DCR) was higher in the SBRT + IL-2 group (75% vs 60%, p=0.34).
CONCLUSIONS


SBRT + IL-2 induced more objective responses with a higher DCR compared to IL-2 monotherapy in MM. IL-2 monotherapy resulted in a significantly higher ORR than anticipated. Some patients in the crossover group also achieved objective responses.
TRIAL REGISTRATION NUMBER


NCT01416831.",2020,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"['patients with advanced melanoma', 'patients with metastatic melanoma (MM', '44 patients were included in the analysis', 'Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible', 'patients with metastatic melanoma']","['IL-2', 'monotherapy', 'IL-2 monotherapy', 'SBRT + IL-2', 'SBRT', 'stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2', 'stereotactic body radiotherapy and interleukin-2 versus interleukin-2']","['objective response rate (ORR', 'progression-free or overall survival (OS', 'ORR', 'objective responses', 'disease control rate (DCR', 'ORR of SBRT + IL-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]",44.0,0.306046,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Curti', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA brendan.curti@providence.org.'}, {'ForeName': 'Marka', 'Initials': 'M', 'LastName': 'Crittenden', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Seung', 'Affiliation': 'Division of Radiation Oncology, The Oregon Clinic, Portland, Oregon, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Fountain', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Payne', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'ShuChing', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Medical Data Research Center, Providence St Joseph Health, Portland, Oregon, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleser', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Malkasian', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Lyn B', 'Initials': 'LB', 'LastName': 'Dobrunick', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Urba', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000773']
2603,32467323,"Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: the first multicentre, phase III trial in China.","BACKGROUND AND PURPOSE


Data on the efficacy and safety of alteplase for acute ischaemic stroke (AIS) administered 3-4.5 hours after the onset of stroke symptoms in Chinese patients is limited. We sought to determine whether AIS patients would benefit from thrombolysis with alteplase between 3 and 4.5 hours after the onset of stroke symptoms in a prospective, multicentre, single-arm trial in China.
MATERIALS AND METHODS


Eligible AIS patients were given 0.9 mg/kg alteplase intravenously. The primary efficacy endpoint was a favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale. Thresholds for the primary efficacy endpoint were determined to be 40% based on the literature review. The primary safety endpoint was symptomatic intracranial haemorrhage (sICH) according to the European Cooperative Acute Stroke Study III (ECASS III) trial definition. Post hoc analysis between this study and the ECASS III trial were compared using the propensity score matching (PSM) method.
RESULTS


A total of 120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study. The median time from onset of symptoms to needle was 3 hours 54 min. The percentage of patients with a favourable outcome was 63.3% (95% CI 54.4 to 71.4), significantly higher than the predefined threshold (p<0.0001). Three patients (2.5%, 95% CI 0.5 to 7.1) had sICH, including two fatal sICH. Six patients died within 3 months after treatment. The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
CONCLUSIONS


Intravenous alteplase with a standard dose administered between 3 and 4.5 hours after onset of symptoms is effective and safe for Chinese AIS patients.
TRIAL REGISTRATION NUMBER


NCT02930837.",2020,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","['120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study', 'Chinese AIS patients', 'Chinese patients', 'Eligible AIS patients']","['alteplase', 'Intravenous alteplase', 'placebo']","['symptomatic intracranial haemorrhage (sICH', 'favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale', 'median time from onset of symptoms to needle']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",120.0,0.198498,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","[{'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Chuanling', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yangkun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Neurology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Fu-Dong', 'Initials': 'FD', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, No.900 Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Zuneng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Songbiao', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, Yanbian University Hospital, Yanji, China.'}, {'ForeName': 'Anding', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'Neurology, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000337']
2604,32467339,Particle depletion of diesel exhaust restores allergen-induced lung-protective surfactant protein D in human lungs.,"RATIONALE


Exposure to air pollution is linked with increased asthma morbidity and mortality. To understand pathological processes linking air pollution and allergen exposures to asthma pathophysiology, we investigated the effect of coexposure to diesel exhaust (DE) and aeroallergen on immune regulatory proteins in human airways.
METHODS


Fourteen allergen-sensitised participants completed this randomised, double-blinded, cross-over, controlled exposure study. Each participant underwent four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure) on different order-randomised dates, each separated by a 4-week washout. Serum and bronchoalveolar lavage (BAL) were assayed for pattern recognition molecules, cytokines, chemokines and inflammatory mediators.
RESULTS


In human airways, allergen-alone exposure led to accumulation of surfactant protein D (SPD; p=0.02). Coexposure to allergen and DE did not elicit the same increase of SPD as did allergen alone; diesel particulate reduction restored allergen-induced SPD accumulation. Soluble receptor for advanced glycation end products was higher with particle reduction than without it. In the systemic circulation, there was a transient increase in SPD and club cell protein 16 (CC16) 4 hours after allergen alone. CC16 was augmented by PDDE, but not DE. % eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen. IL-5, SPD and % eosinophils in BAL were correlated with decreased FEV 1 .
CONCLUSION


Short-term coexposure to aeroallergen and DE alters immune regulatory proteins in lungs; surfactant levels are dependent on particle depletion.
TRIAL REGISTRATION NUMBER


NCT02017431.",2020,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","['human airways', 'Fourteen allergen-sensitised participants', 'human lungs']","['four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure', 'coexposure to diesel exhaust (DE', 'diesel exhaust restores allergen-induced lung-protective surfactant protein D']","['CC16', 'asthma morbidity and mortality', 'IL-5, SPD and % eosinophils in BAL', 'Serum and bronchoalveolar lavage (BAL', 'SPD and club cell protein']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}]","[{'cui': 'C0225668', 'cui_str': 'Clara cell of bronchiole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.106351,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","[{'ForeName': 'Min Hyung', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kevin Soon-Keen', 'Initials': 'KS', 'LastName': 'Lau', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise Jill', 'Initials': 'DJ', 'LastName': 'Wooding', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': ""Centre for Heart Lung Innovation, St. Paul's Hospital, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada carlsten@mail.ubc.ca.'}]",Thorax,['10.1136/thoraxjnl-2020-214561']
2605,32467354,"Engaging men to transform inequitable gender attitudes and prevent intimate partner violence: a cluster randomised controlled trial in North and South Kivu, Democratic Republic of Congo.","INTRODUCTION


The study objective was to understand the effectiveness of Engaging Men through Accountable Practice (EMAP), a group-based discussion series which sought to transform gender relations in communities, on intimate partner violence (IPV), gender inequitable attitudes and related outcomes.
METHODS


A two-armed, matched-pair, cluster randomised controlled trial was conducted between 2016 and 2018 in eastern Democratic Republic of Congo. Adult men (n=1387) and their female partners (n=1220) participated in the study. The primary outcomes of the study were female report of past year physical and/or sexual IPV and men's intention to commit violence. Secondary outcomes included men's gender attitudes, women's economic and emotional IPV, women's perception of negative male behaviours and perceived quality of the relationship.
RESULTS


Men in EMAP reported significant reductions in intention to commit violence (β=-0.76; SE=0.23; p<0.01), decreased agreement with any reason that justifies wife beating (OR=0.59; SE=0.08; p<0.01) and increased agreement with the ability of a woman to refuse sex for all reasons (OR=1.47; SE=0.24; p<0.05), compared with men in the control group. We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71). However, female partners of men in EMAP reported significant improvements to the quality of relationship (β=0.28; p<0.05) and significant reductions in negative male behaviour (β=-0.32; p<0.01).
CONCLUSION


Interventions engaging men have the potential to change gender attitudes and behaviours in conflict-affected areas. However, while EMAP led to changes in gender attitudes and behaviours related to perpetration of IPV, the study showed no overall reduction of women's experience of IPV. Further research is needed to understand how working with men may lead to long-term and meaningful changes in IPV and related gender equitable attitudes and behaviours in conflict areas.
TRIAL REGISTRATION NUMBER


NCT02765139.",2020,We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71).,"['2016 and 2018 in eastern Democratic Republic of Congo', 'Adult men ', 'North and South Kivu, Democratic Republic of Congo', 'n=1387) and their female partners (n=1220) participated in the study']","['Engaging Men through Accountable Practice (EMAP', 'EMAP']","['negative male behaviour', ""female report of past year physical and/or sexual IPV and men's intention to commit violence"", 'intention to commit violence', ""men's gender attitudes, women's economic and emotional IPV, women's perception of negative male behaviours and perceived quality of the relationship"", 'intimate partner violence']","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0680385,We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Vaillant', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA jvaillant@worldbank.org.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Koussoubé', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'Violence Prevention and Response Unit, International Rescue Committee, Tunis, Tunisia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Pierotti', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA.'}, {'ForeName': 'Mazeda', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'Airbel Impact Lab, International Rescue Committee, Washington, DC, USA.'}]",BMJ global health,['10.1136/bmjgh-2019-002223']
2606,32467402,Noise Level and Comfort in Healthy Subjects Undergoing High-Flow Helmet Continuous Positive Airway Pressure.,"AIM


The aim of this study was to assess the noisiness levels produced by different gas source systems, breathing circuits setup, and gas flow rates during continuous positive airway pressure (CPAP) delivered through helmet.
METHODS


This was a crossover design study. Ten healthy subjects received helmet CPAP at 5 cm H2O in random order with different gas flow rates (60 and 80 L/min), 3 diverse gas source systems (A: Venturi system, B: oxygen and air flowmeters, C: electronic Venturi system), and 3 different breathing circuit configurations. During every step of this study, a heat and moisture exchanger (HME) was placed on the helmet inlet gas port to measure the effects on noise production. Noise intensity level was recorded through a sound-level meter. Participants scored their noisiness perception on a visual analog scale.
RESULTS


The noise level inside the helmet ranged between 76 ± 4 and 117 ± 1 Decibel A. The gas source and the gas flow rate always affected the noise level inside and outside the helmet (P < .001). The different ""breathing circuit setup"" did not change the noise levels inside the helmet (P = .244), but affected the noise level outside, especially when a Venturi system was used (P < .001). An HME filter placed at the junction between the inspiratory limb of the breathing circuit and the helmet significantly decreased the noise intensity inside the helmet (mean dBA without HME, 99.56 ± 13.30 vs 92.26 ± 10.72 with HME; P < .001) and outside (mean dBA without HME, 68.16 ± 12.05 vs 64.97 ± 12.17 with HME; P < .001). The perception of noise inside the helmet was lower when an HME filter was placed on the inspiratory inlet gas port (median, 6 [interquartile range, 4-7] vs 7 [5-8]; P < .001).
CONCLUSIONS


When helmet CPAP is delivered through gas flow rates up to 50 L/min, an HME placed on the helmet inlet gas port should be used to reduce noise inside the helmet and to improve patients' comfort.",2020,"The different ""breathing circuit setup"" did not change the noise levels inside the helmet (P = .244), but affected the noise level outside, especially when a Venturi system was used (P < .001).","['Healthy Subjects Undergoing High-Flow Helmet Continuous Positive Airway Pressure', 'Ten healthy subjects received']","['helmet CPAP', '3 diverse gas source systems (A: Venturi system, B: oxygen and air flowmeters, C: electronic Venturi system), and 3 different breathing circuit configurations', 'continuous positive airway pressure (CPAP) delivered through helmet', 'heat and moisture exchanger (HME']","['perception of noise inside the helmet', 'Noise intensity level', 'noise intensity inside the helmet', 'visual analog scale', 'Noise Level and Comfort']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016266', 'cui_str': 'Flowmeter'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0179423', 'cui_str': 'Breathing circuit'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0181233', 'cui_str': 'Heat and moisture exchanger'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",10.0,0.0241768,"The different ""breathing circuit setup"" did not change the noise levels inside the helmet (P = .244), but affected the noise level outside, especially when a Venturi system was used (P < .001).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Lucchini', 'Affiliation': ""Alberto Lucchini, RN, General Intensive Care Unit, Emergency Department, ASST Monza, San Gerardo Hospital, Monza; and University of Milano-Bicocca, Milan, Italy. He is the coordinator of the master's degree program in intensive and critical care nursing at Milano-Bicocca University, Italy. His main publications concern the nursing workload in intensive care, nursing care of ECMO patients, invasive and non-invasive mechanical ventilation, endotracheal suctioning. Stefano Bambi, PhD, MSN, RN, Medical and Surgical Intensive Care Unit, Careggi University Hospital, Florence, Italy. He is a staff nurse and professor in charge at Florence University and Milano-Bicocca University. His main publications concern the, invasive and non-invasive mechanical ventilation, nursing in critical care settings. Silvia Gurini, RN, Emergency Department, ASST Valtellina ed Alto Lario, Italy. Enrico di Francesco, RN, Cardiosurgical Intensive Care Unit, S. Antonio Hospital, Padova, Italy. Luigino Pace, RN, General Intensive Care Unit, APSS-Santa Maria del Carmine Hospital, Rovereto, Italy. Roberto Rona, MD, General Intensive Care Unit, Emergency Department, ASST Monza, San Gerardo Hospital, Monza; and University of Milano-Bicocca, Milan, Italy. Roberto Fumagalli, MD, is a professor in the University of Milan-Bicocca located in Milan, Italy. He is also the director of the Department of Anesthesia and Intensive Care Medicine, Niguarda Ca' Granda Hospital of Milan, Italy. Giuseppe Foti, MD, General Intensive Care Unit, Emergency Department, ASST Monza, San Gerardo Hospital, Monza; and University of Milano-Bicocca, Milan. Stefano Elli, RN, General Intensive Care Unit, Emergency Department, ASST Monza, San Gerardo Hospital, Monza; and University of Milano-Bicocca, Milan.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bambi', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gurini', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Francesco', 'Affiliation': ''}, {'ForeName': 'Luigino', 'Initials': 'L', 'LastName': 'Pace', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rona', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Fumagalli', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Foti', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Elli', 'Affiliation': ''}]",Dimensions of critical care nursing : DCCN,['10.1097/DCC.0000000000000430']
2607,32467415,A Telemedicine Approach to Increase Treatment of Alcohol Use Disorder in Primary Care: A Pilot Feasibility Study.,"BACKGROUND AND AIMS


Unhealthy drinking is a leading threat to health, yet few people with alcohol use disorder (AUD) receive treatment. This pilot tested the feasibility of addiction medicine video consultations in primary care for improving AUD medication adoption and specialty treatment initiation.
METHODS


Primary care providers (PCPs) received training and access to on-call addiction medicine consultations. Feasibility measures were training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback. Secondary outcomes were utilization, prescription and treatment initiation rates, and case reports. χ tests were used to compare prescription and treatment initiation rates for consult recipients and non-recipients.
RESULTS


Ninety-one PCPs (71.1%) attended a training, and 60 (65.9%) provided feedback. Of those, 37 (64.9%) mentioned pharmacotherapy and 41 (71.9%) intended to use the video consult service. Of 27 users, 19 provided feedback; 12 (63.1%) rated its value at 8 or above, on a scale of 1 to 10 (average 6.9). The most useful aspect was immediacy, and users wanted an easier workflow and increased consultant availability. Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
CONCLUSIONS


PCP training attendance and feedback suggest that an addiction telemedicine consult service would be valuable to PCPs and might increase AUD medication uptake and specialty addiction treatment initiation. However, future research should include significant modifications to the piloted telemedicine model: robust staffing and simpler, more flexible methods for PCPs to obtain consults.",2020,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","['Alcohol Use Disorder in Primary Care', 'Primary care providers (PCPs) received']","['training and access to on-call addiction medicine consultations', 'naltrexone', 'addiction medicine video consultations']","['training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback', 'utilization, prescription and treatment initiation rates, and case reports']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4505067', 'cui_str': 'Addiction Medicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}]",,0.0441061,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA (AL, DDS, WL, CW, SS), Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Avenue, San Francisco, CA (DDS), The Permanente Medical Group, Addiction Medicine and Recovery Services, 380\u200aW MacArthur Blvd, Oakland, CA (CC), The Permanente Medical Group, East Bay Technology, 901 Nevin Avenue, Richmond, CA (EG).'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Weisner', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Corriveau', 'Affiliation': ''}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Gizzi', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sterling', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000666']
2608,32467417,"A randomised, placebo-controlled pilot study of a nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury.","BACKGROUND


Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α.
OBJECTIVE


The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy.
DESIGN


Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study.
SETTING


Eight secondary care centres, the United Kingdom between April 2015 and June 2017.
PATIENTS


Thirty-three patients undergoing elective transthoracic oesophagectomy.
INTERVENTIONS


Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study.
MAIN OUTCOME MEASUREMENTS


Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models.
RESULTS


The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (-0.23, 0.39) in the placebo and 0.00 (-0.24, 0.37) in the GSK2862277 treatment groups. There were no significant treatment-related differences in PaO2/FiO2 or Sequential Organ Failure Assessment score. Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05). The frequency of adverse events and serious adverse events were distributed evenly across the two treatment arms.
CONCLUSION


Pre-operative treatment with a single 26 mg inhaled dose of GSK2862277 did not result in significantly lower postoperative alveolar capillary leak or extra vascular lung water. Unexpectedly small increases in transpulmonary thermodilution-measured PVPI and extra vascular lung water index at completion of surgery suggest less postoperative lung injury than historically reported, which may have also compromised a clear assessment of efficacy in this trial. GSK2862277 was well tolerated, resulted in expected lung exposure and reduced biomarkers of lung permeability and inflammation.
TRIAL REGISTRATION


clinicaltrials.gov: NCT02221037.",2020,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","['patients undergoing oesophagectomy', 'patients at risk of postoperative lung injury', 'Thirty-three patients undergoing elective transthoracic oesophagectomy', 'Eight secondary care centres, the United Kingdom between April 2015 and June 2017']","['GSK2862277', 'nebulised TNFR1 antagonist (GSK2862277', 'nebulised antitumour necrosis factor receptor-1 domain antibody', 'placebo']","['Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints', 'PaO2/FiO2 or Sequential Organ Failure Assessment score', 'postoperative alveolar capillary leak or extra vascular lung water', 'Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein', 'lung exposure and reduced biomarkers of lung permeability and inflammation', 'frequency of adverse events and serious adverse events', 'pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4279387', 'cui_str': 'GSK2862277'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1382398', 'cui_str': 'Increased capillary permeability'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0128546', 'cui_str': 'Small Inducible Cytokine A3'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0039807', 'cui_str': 'Thermodilution'}]",33.0,0.589958,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough (JR), GlaxoSmithKline Research and Development, Stevenage (AIB, TJW, EM, WP, RW, AF), Centre for Experimental Medicine, Queen's University of Belfast (DFM), Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (DFM), Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry (JY, GDP), Birmingham Acute Care Research Group, Institute of Inflammation and Aging, School of Clinical and Experimental Medicine, University of Birmingham (DRT, PAH), University Hospitals Birmingham, NHS Foundation Trust, Birmingham (JY, DRT, PAH, GDP), Department of Anaesthesia, Royal Victoria Hospital, Belfast (COD, MOS), Department of Medicine, University of Cambridge, Cambridge (AMV, CS), GlaxoSmithKline R&D, Stockley Park (KH), Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK (CS) and GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, USA (ALL).""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Bayliffe', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Howells', 'Affiliation': ''}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'Arlette M', 'Initials': 'AM', 'LastName': 'Vassallo', 'Affiliation': ''}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McKie', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hardes', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Shields', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Powley', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001245']
2609,32467522,"Pain Score Assessment Using Single-Dose IV Ketorolac Only, After External Dacryocystorhinostomy: A Randomized Double/Triple-Blind Placebo-Controlled Trial.","PURPOSE


To assess efficacy of intravenous (IV) ketorolac for postoperative pain control after external dacryocystorhinostomy.
METHOD


Fifty-five patients from January to April 2019 were randomized, to a double-blind prospective interventional study. Intervention arm received IV ketorolac (60 mg/2 ml) immediately post-op, control received IV saline bolus. Pain assessment was done with numerical rating scale pre- and postinjection (day 0) and on day 1. Requirement for analgesics and antiemetics was recorded.
RESULTS


Total 55 patients (11 men and 44 women) with mean age 49.93 ± 16.29 years were included in the study. Twenty-four (43.6%) patients received IV ketorolac and 31 (56.4%) received placebo. Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003).
CONCLUSION


IV ketorolac significantly lowers self-reported pain score following external dacryocystorhinostomy with reduced requirement of analgesic and antiemetic medications.",2020,"Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003).
","['Total 55 patients (11 men and 44 women) with mean age 49.93 ± 16.29 years were included in the study', 'Fifty-five patients from January to April 2019']","['Placebo', 'intravenous (IV) ketorolac', 'External Dacryocystorhinostomy', 'IV ketorolac', 'ketorolac', 'placebo']","['mean rank score for pain scale', 'postoperative pain control', 'Pain Score Assessment', 'Pain assessment', 'lowers self-reported pain score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",55.0,0.486885,"Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003).
","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Fellow, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Patidar', 'Affiliation': 'Consultant and Head, Orbit and Oculoplasty, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Harshdeep Singh', 'Initials': 'HS', 'LastName': 'Gabba', 'Affiliation': 'Fellow, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Devindra', 'Initials': 'D', 'LastName': 'Sood', 'Affiliation': 'Head Academics & Research and Training, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Parimal', 'Initials': 'P', 'LastName': 'Piush', 'Affiliation': 'Consultant, Orbit and Oculoplasty, Sadguru Netra Chikitsalaya, Chitrakoot, Madhya Pradesh, India.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001730']
2610,32467540,The effectiveness of diabetes medication therapy adherence clinic to improve glycaemic control among patients with type 2 diabetes mellitus: a randomised controlled trial.,"INTRODUCTION


In Malaysia, Diabetes Medication Therapy Adherence Clinic (DMTAC) in hospital settings significantly improved patients' glycaemic control and cardiovascular risk. Until now no randomised controlled trial of DMTAC has been done in a primary care setting where the access to subspecialist services (endocrinologists, expensive medication, etc.) is limited. The objective of this research is to compare the glycaemic control among diabetes mellitus (DM) patients between those received additional DMTAC service and those received normal clinic service in primary care settings.
MATERIALS AND METHOD


This was a parallel, randomised controlled study. The selected participants were patients aged 18 to 70 years with type 2 DM on diabetic medication who were being treated in Kota Samarahan Health Clinic with HbA1c above 8% and who never attended any education of DM prior to the study. The control group received normal clinic visits with consultations by a medical officer. The intervention group received four or more DMTAC visits in addition to normal clinic visits. The primary outcomes were HbA1c while the secondary outcomes were the occurrence of severe hypoglycaemia, weight gain and medication compliance of patients. The subjects were randomised by numbered envelope opened chronologically by the investigator during the initial assessment. All health care professionals (nurse, lab staff and medical officer) except DMTAC pharmacist managing the subjects were blinded as there were no markings on the patients notes indicating that they were in this study. The demographic data was collected during screening while health data including glycated haemoglobin (HbA1c) levels were collected at baseline, sixth month and one year.
RESULTS


In all, 100 patients were randomised into control and intervention groups (n=50 per arm). The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627). Both study groups had similar significant changes of subjects from non-compliance to compliance (control group, n=11 vs. intervention group, n=10). The changes of BMI after 12 months between control group (0.24 kg/m2) and intervention group (0.24 kg/m2) was not significant (p=0.910). There were no episodes of severe hypoglycaemia detected in both groups.
CONCLUSION


The addition of DMTAC service in primary care can improve glycaemic control among patients. The study was registered in the National Medical Research Register (Malaysia): NMRR-13-1449-18955.",2020,"The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627).","['diabetes mellitus (DM) patients between those received additional DMTAC service and those received normal clinic service in primary care settings', 'patients with type 2 diabetes mellitus', 'selected participants were patients aged 18 to 70 years with type 2 DM on diabetic medication who were being treated in Kota Samarahan Health Clinic with HbA1c above 8% and who never attended any education of DM prior to the study', 'National Medical Research Register (Malaysia', 'patients', '100 patients']","['DMTAC', 'diabetes medication therapy adherence clinic', 'normal clinic visits with consultations by a medical officer']","['change of HbA1c', 'glycaemic control and cardiovascular risk', 'severe hypoglycaemia', 'changes of BMI', 'glycated haemoglobin (HbA1c) levels', 'glycaemic control', 'occurrence of severe hypoglycaemia, weight gain and medication compliance of patients']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0557286', 'cui_str': 'No formal education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",100.0,0.0674614,"The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Alison', 'Affiliation': 'Klinik Kesihatan Kota Samarahan, 94300 Kota Samarahan, Sarawak, and Universiti Malaysia Sarawak, Malaysia. chai.alison@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anselm', 'Affiliation': 'Universiti Malaysia Sarawak, Malaysia.'}]",The Medical journal of Malaysia,[]
2611,32467546,Bioequivalence and pharmacokinetic comparison of two fixed dose combination of Metformin/ Glibenclamide formulations in healthy subjects under fed condition.,"AIM


This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet).
MATERIALS AND METHODS


This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS


The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION


It can be concluded that the test preparation is bioequivalent to the reference preparation.",2020,"Throughout the study period, no serious drug reaction was observed.","['healthy subjects under fed condition', '28 adult male subjects']","['standardized high-fat and high-calorie breakfast', 'Metformin/ Glibenclamide formulations', 'metformin/glibenclamide tablets', 'glibenclamide and metformin']","['headache (n=2) and excessive hunger', 'Plasma levels', 'AUC0-t, AUC0-∞, and Cmax of the test preparation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2936315', 'cui_str': 'Test Preparation'}]",28.0,0.0305593,"Throughout the study period, no serious drug reaction was observed.","[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Chang', 'Affiliation': 'Hospital Raja Permaisuri Bainun, Clinical Research Centre, Ipoh, Perak, Malaysia. davidcct.crc@gmail.com.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Ang', 'Affiliation': 'Hospital Raja Permaisuri Bainun, Clinical Research Centre, Ipoh, Perak, Malaysia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Wong', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Chin', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Lim', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}]",The Medical journal of Malaysia,[]
2612,32467558,Efficacy and Safety of Ureteral Catheter Use During Arteriovenous Fistula in End-Stage Renal Disease Patients with Poor Vascular Status.,"BACKGROUND The aim of this study was to evaluate the efficacy and safety of use of a ureteral catheter during arteriovenous fistula in end-stage renal disease patients with poor vascular status. MATERIAL AND METHODS Fifty patients with standard arteriovenous fistulas at Sir Run Run Hospital of Nanjing Medical University from April 2018 to April 2019 were included. Based on the use of ureteral catheter exploration and tourniquet hydraulic dilatation, patients were divided into study and control groups. The operative success rate, inner diameter of cephalic vein 1 day post-operatively, blood flow in the internal fistula, patency rate and blood flow in the internal fistula 3 months post-operatively, and complications 6 months post-operatively were compared between the 2 groups. RESULTS There were 25 cases in each group, with no significant differences in sex or age between the 2 groups. The operative success rate in the study group was higher than in the control group (96% vs. 88%) (F=1.087, P=0.297). The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group. The inner diameter of the cephalic vein 1 day post-operatively, the blood flow in the internal fistula, and the complications 6 months post-operatively in the study group were significantly superior to those of the control group (P=0.002). CONCLUSIONS In standard arteriovenous fistula, especially vascular catheter exploration of unhealthy vessels, the application of a ureteral catheter can improve the operative success rate and promote internal fistula maturity, with low cost and ease of use.",2020,The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group.,"['End-Stage Renal Disease Patients with Poor Vascular Status', 'end-stage renal disease patients with poor vascular status', 'Fifty patients with standard arteriovenous fistulas at Sir Run Run Hospital of Nanjing Medical University from April 2018 to April 2019 were included']","['ureteral catheter exploration and tourniquet hydraulic dilatation', 'ureteral catheter', 'Ureteral Catheter Use']","['Efficacy and Safety', 'operative success rate, inner diameter of cephalic vein 1 day post-operatively, blood flow in the internal fistula, patency rate and blood flow', 'patency rates', 'efficacy and safety', 'operative success rate', 'blood flow']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0333330', 'cui_str': 'Internal fistula'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",50.0,0.0150771,The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group.,"[{'ForeName': 'Yongchao', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Shensen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920421']
2613,32467559,Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post Hoc Analysis of the Prospective OSAKA Study.,"BACKGROUND This post hoc analysis of data from the prospective OSAKA study evaluated the efficacy and safety of prolonged- and immediate-release tacrolimus in patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors. MATERIAL AND METHODS Within the ECD and SCD groups, patients were randomized to one of 4 tacrolimus-based regimens (initial dose): Arm 1, immediate-release tacrolimus (0.2 mg/kg/day); Arm 2, prolonged-release tacrolimus (0.2 mg/kg/day); Arm 3, prolonged-release tacrolimus (0.3 mg/kg/day); Arm 4, prolonged-release tacrolimus (0.2 mg/kg/day) plus basiliximab. All patients received mycophenolate mofetil and bolus corticosteroids; Arms 1-3 also received tapered corticosteroids. ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death. Primary composite endpoint: graft loss, biopsy-confirmed acute rejection or renal dysfunction by Day 168. Outcomes were compared across treatment arms with the chi-squared or Fisher's exact test. RESULTS A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2%]). Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001). A higher proportion of patients with kidneys from ECDs versus SCDs met the primary composite endpoint (56.8% vs. 32.4%, p<0.0001). However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group. CONCLUSIONS Worse outcomes were experienced in patients who received kidneys from ECDs versus SCDs. Prolonged-release tacrolimus provided similar graft survival to the immediate-release formulation, with a manageable tolerability profile.",2020,"However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group.","['After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post', 'A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2', 'Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001', 'patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors', 'ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death']","['immediate-release tacrolimus', 'prolonged-release tacrolimus', 'tapered corticosteroids', 'Tacrolimus-Based Immunosuppression', 'prolonged- and immediate-release tacrolimus', 'tacrolimus', 'mycophenolate mofetil and bolus corticosteroids']","['efficacy and safety', 'clinical outcomes or the incidence of treatment-emergent adverse events', 'graft loss, biopsy-confirmed acute rejection or renal dysfunction', 'graft survival']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0014116', 'cui_str': 'Endocardial cushion defect'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",1198.0,0.117023,"However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group.","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Albano', 'Affiliation': 'Department of Nephrology, University Hospital Center of Nice, Nice, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Banas', 'Affiliation': 'Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lehner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Glyda', 'Affiliation': 'Department of Transplantology and Surgery, District Public Hospital, Poznań, Poland.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Viklicky', 'Affiliation': 'Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schleibner', 'Affiliation': 'Formerly Astellas Pharma GmbH, Munich, Germany.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, CHU Rangueil, Paul Sabatier University, INSERM U10403, Toulouse, France.'}]",Annals of transplantation,['10.12659/AOT.920041']
2614,32467635,Effects of different mydriatics on the choroidal vascularity in healthy subjects.,"PURPOSE


To evaluate choroidal vasculature changes after the instillation of mydriatic parasympatholytic and sympathomimetic agents in healthy subjects.
METHODS


A total of 95 healthy subjects were enrolled in this prospective, randomized comparative study. Study participants were divided into three different groups depending on the drug to be administered: tropicamide (1%) group (n = 31), tropicamide (0.5%) + phenylephrine (10%) group (n = 30) and control group receiving artificial tears (n = 34). All participants underwent a complete ophthalmological examination including best corrected visual acuity, refractive status and axial length. Subfoveal choroidal thickness (CT), total choroidal area (TCA), luminal and stromal choroidal area (LCA and SCA) and choroidal vascularity index (CVI) were measured before and after eye drops instillation.
RESULTS


All the baseline characteristics were matched between the three groups (all P > 0.05). Before the mydriatic instillation, there were no significant differences of CT, TCA, LA, SCA, and CVI among the three groups (all P > 0.05). After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
CONCLUSIONS


Instillation of mydriatic eye drops did not induce significant changes of the choroidal vasculature, suggesting that their use do not alter CT and CVI evaluation.",2020,"After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
","['95 healthy subjects', 'healthy subjects']","['tropicamide (0.5%)\u2009+\u2009phenylephrine', 'tropicamide', 'mydriatic parasympatholytic and sympathomimetic agents', 'control group receiving artificial tears']","['corrected visual acuity, refractive status and axial length', 'Subfoveal choroidal thickness (CT), total choroidal area (TCA), luminal and stromal choroidal area (LCA and SCA) and choroidal vascularity index (CVI', 'CT, TCA, LA, SCA, and CVI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C0030511', 'cui_str': 'Parasympathetic-Blocking Agents'}, {'cui': 'C0039052', 'cui_str': 'Sympathomimetic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0036056', 'cui_str': 'St. Lucia'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",95.0,0.0279034,"After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Iovino', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Chhablani', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Mohammed Abdul', 'Initials': 'MA', 'LastName': 'Rasheed', 'Affiliation': 'School of Optometry and Vision Science, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Tatti', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bernabei', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giannaccare', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Peiretti', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy. enripei@hotmail.com.'}]","Eye (London, England)",['10.1038/s41433-020-0995-9']
2615,32467641,The impact of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on arterial stiffness and blood pressure in young obese women: a randomized controlled trial.,,2020,,['young obese women'],['high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT'],['arterial stiffness and blood pressure'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.108794,,"[{'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boutouyrie', 'Affiliation': 'Department of Pharmacology, University Paris Descartes, Paris, France.'}, {'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'João C', 'Initials': 'JC', 'LastName': 'Locatelli', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Victor H S', 'Initials': 'VHS', 'LastName': 'Mendes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Higor B', 'Initials': 'HB', 'LastName': 'Reck', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Carla Eloise', 'Initials': 'CE', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Rogério T P', 'Initials': 'RTP', 'LastName': 'Okawa', 'Affiliation': 'Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil. warthurlopes@gmail.com.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0477-2']
2616,32467653,Improving Developmental Abilities in Infants With Tuberous Sclerosis Complex: A Pilot Behavioral Intervention Study.,"Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers risk for neurodevelopmental disorders, including autism spectrum disorder and intellectual disability. Delays in social communication and early cognitive abilities are observable as early as 9 months of age in children with TSC; however, there have been no studies of early behavioral intervention in TSC. We conducted a pilot study of an evidence-based, parent-mediated behavioral intervention focused on improving early social communication and play skills in 5 children with TSC (aged 1-3 years). Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention. Parents generally found the intervention to be helpful and were able to administer the intervention with fidelity. Preliminary results demonstrate initial feasibility of an early play-based, parent-mediated intervention and support the need for a large-scale, randomized clinical trial in TSC.",2020,"Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention.","['5 children with TSC (aged 1-3 years', 'Infants With Tuberous Sclerosis Complex', 'children with TSC']",['parent-mediated behavioral intervention'],"['social communication and early cognitive abilities', 'early social communication and play skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",5.0,0.0468889,"Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'McDonald', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Hyde', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'April Boin', 'Initials': 'AB', 'LastName': 'Choi', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Gulsrud', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Shafali S', 'Initials': 'SS', 'LastName': 'Jeste', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}]",Infants and young children,['10.1097/iyc.0000000000000160']
2617,32467655,Functional outcomes comparative analysis of cemented and uncemented total knee arthroplasty.,"Introduction


Cementless knee arthroplasty becomes more and more popular worldwide. At the beginning of endoprosthetics era, cementless implants showed unsatisfactory results. However, surgical technologies develop rapidly and nowadays the cementless fixation shows better outcomes.
Objectives


To analyze the experience of total knee arthroplasty using cementless fixation for the treatment of advanced arthritis of the knee.
Methods


We operated on 130 patients. The mean follow-up duration was 36 months. In 70 patients we used cementless fixation and in 60 patients we used implants with cemented fixation. To evaluate the results, we used KOOS scale and WOMAC scale. We also evaluated the mean duration of surgical intervention and blood loss.
Results


In the cementless group WOMAC and KOOS scales scores before the operation were 198,2 (±35.7) and 23,1 (±3.4), respectively, and in the cemented group it was 199.3(±36.8) and 24.9 (±2.1), respectively(p > 0,05). One year after the operation, KOOS and WOMAC scores were 54.5(±12.6) and 83.6(±8,.2) in the cementless group and 78.9(±4.6) and 66.9(±5.7) in the cemented group(p < 0,05)., respectively. Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p < 0,05). Postoperative blood loss was 515(±119, 5) and 440(±129,3)) (p < 0,05), respectively. Mean duration of intervention was 78 min (±6,8) in cemented group and 64 min (±8,7) in cementless group(p < 0,05).
Conclusions


1We have better functional results using implants with cementless fixation.2There was a greater intraoperative and postoperative blood loss in cementless group.3Cementless knee arthroplasty associated with shorter duration of intervention than cemented.",2020,"Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p ","['advanced arthritis of the knee', '130 patients', 'cementless group(p', '70 patients we used cementless fixation and in 60 patients we used implants with cemented fixation']","['total knee arthroplasty using cementless fixation', 'cemented and uncemented total knee arthroplasty']","['Mean duration of intervention', 'KOOS scale and WOMAC scale', 'KOOS and WOMAC scores', 'mean duration of surgical intervention and blood loss', 'KOOS scales scores', 'Postoperative blood loss was 515(±119, 5) and 440(±129,3', 'Intraoperative blood loss']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",130.0,0.0341711,"Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p ","[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Murylev', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Muzychenkov', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Zhuchkov', 'Affiliation': 'S. P. Botkin Moscow City Clinical Hospital, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Tsygin', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Rigin', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Elizarov', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Kukovenko', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}]",Journal of orthopaedics,['10.1016/j.jor.2020.04.019']
2618,32467688,"The effect of levocetirizine and montelukast on clinical symptoms, serum level and skin expression of COX-1 and COX-2 enzymes in patients suffering from chronic autoimmune urticaria - a pilot study.","Introduction


Chronic autoimmune urticaria (CAU) lasts over 6 weeks and is characterized by circulating IgE autoantibodies or IgG against IgE or IgE receptor.
Aim


To assess the clinical, laboratory and histological effects of 4-week levocetirizine and montelukast therapy in patients suffering from CAU.
Material and methods


Of 296 tested patients with chronic urticaria 40 had a positive ASST test. Only 17 (16 female/1 male; medium age: 44 years) fulfilled all study inclusion/exclusion criteria. The study was designed as an open, randomized trial with two arms: levocetirizine or montelukast treatment for 4 weeks following a 2-week wash-out period. All participants completed urticaria activity score (UAS) and visual analogue scale (VAS) questionnaires before and after both therapies. Blood samples and skin bioptats were obtained before and after treatment to evaluate COX-1 and COX-2 serum concentrations and skin expression.
Results


Clinical response to therapy measured with the UAS and VAS was better in the levocetirizine group. Both drugs caused a significant decrease in COX-1 and COX-2 serum level. COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
Conclusions


The effectiveness of levocetirizine and montelukast in treating CAU may be partly related to the reduction of COX-1 and COX-2 serum level and tissue expression, but further studies on a larger group of patients are needed to support this observation.",2020,"COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
","['296 tested patients with chronic urticaria 40 had a positive ASST test', 'patients suffering from chronic autoimmune urticaria - a pilot study', 'patients suffering from CAU', 'Only 17 (16 female/1 male; medium age: 44 years) fulfilled all study inclusion/exclusion criteria']","['levocetirizine or montelukast', 'levocetirizine', 'levocetirizine and montelukast', 'levocetirizine and montelukast therapy']","['clinical symptoms, serum level and skin expression of COX-1 and COX-2 enzymes', 'COX-1 expression', 'COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration', 'COX-1 and COX-2 serum concentrations and skin expression', 'COX-2 expression', 'COX-1 and COX-2 serum level', 'Blood samples and skin bioptats', 'urticaria activity score (UAS) and visual analogue scale (VAS) questionnaires', 'UAS and VAS']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1304193', 'cui_str': 'Chronic autoimmune urticaria'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1565830', 'cui_str': 'PTGS1 protein, human'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0302158', 'cui_str': 'Leucocytic infiltrate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",296.0,0.0205452,"COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Korczyñska-Krawczyk', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Kupryś-Lipiñska', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kupczyk', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wągrowska-Danilewicz', 'Affiliation': 'Department of Nephropathology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Szemraj', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Health Sciences with the Division of Nursing and Midwifery, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Bienias', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Narbutt', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Śmigielski', 'Affiliation': 'Social and Technical Department, State Higher Vocational School, Konin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}]",Postepy dermatologii i alergologii,['10.5114/ada.2018.79731']
2619,32467712,Moderate- to high intensity aerobic and resistance exercise reduces peripheral blood regulatory cell populations in older adults with rheumatoid arthritis.,"Objective


Exercise can improve immune health and is beneficial for physical function in patients with rheumatoid arthritis (RA), but the immunological mechanisms are largely unknown. We evaluated the effect of moderate- to high intensity exercise with person-centred guidance on cells of the immune system, with focus on regulatory cell populations, in older adults with RA.
Methods


Older adults (≥65 years) with RA were randomized to either 20-weeks of moderate - to high intensity aerobic and resistance exercise ( n  = 24) or to an active control group performing home-based exercise of light intensity ( n  = 25). Aerobic capacity, muscle strength, DAS28 and CRP were evaluated. Blood samples were collected at baseline and after 20 weeks. The frequency of immune cells defined as adaptive regulatory populations, CD4 + Foxp3 + CD25 + CD127- T regulatory cells (Tregs) and CD19 + CD24hiCD38hi B regulatory cells (Bregs) as well as HLA-DR-/lowCD33 + CD11b + myeloid derived suppressor cells (MDSCs), were assessed using flow cytometry.
Results


After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP. The frequency of Tregs and Bregs decreased significantly in the intervention group, but not in the active control group. The exercise intervention had no effect on MDSCs. The reduction in regulatory T cells in the intervention group was most pronounced in the female patients.
Conclusion


Moderate- to high intensity exercise in older adults with RA led to a decreased proportion of Tregs and Bregs, but that was not associated with increased disease activity or increased inflammation.
Trial registration


Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study, NCT02397798. Registered at ClinicalTrials.gov March 19, 2015.",2020,"After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP.","['female patients', 'older adults with RA', 'older adults with rheumatoid arthritis', 'Methods\n\n\nOlder adults (≥65\u2009years) with RA', 'patients with rheumatoid arthritis (RA', 'Elderly Patients']","['exercise intervention', 'moderate- to high intensity exercise with person-centred guidance', 'moderate - to high intensity aerobic and resistance exercise ( n \u2009=\u200924) or to an active control group performing home-based exercise of light intensity', 'Moderate- to high intensity aerobic and resistance exercise']","['Disease Activity Score 28 (DAS28) or CRP', 'frequency of immune cells defined as adaptive regulatory populations, CD4\u2009+\u2009Foxp3\u2009+\u2009CD25\u2009+\u2009CD127- T regulatory cells (Tregs) and CD19\u2009+\u2009CD24hiCD38hi B regulatory cells (Bregs', 'Blood samples', 'MDSCs', 'intensity exercise, aerobic capacity and muscle strength', 'regulatory T cells', 'frequency of Tregs and Bregs', 'Aerobic capacity, muscle strength, DAS28 and CRP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0083032', 'cui_str': 'Interleukin-7 receptor'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C3178914', 'cui_str': 'B-Cells, Regulatory'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4277543', 'cui_str': 'MDSCs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}]",,0.0340539,"After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP.","[{'ForeName': 'Sofia E M', 'Initials': 'SEM', 'LastName': 'Andersson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': '2University of Gothenburg Centre for Person-Centred Care, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kucharski', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Svedlund', 'Affiliation': '4Department of Molecular and Clinical Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Önnheim', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bergquist', 'Affiliation': '5Department of Medical Sciences, Clinical Physiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Josefsson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Lord', 'Affiliation': '6MRC-ARUK Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Inga-Lill', 'Initials': 'IL', 'LastName': 'Mårtensson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Mannerkorpi', 'Affiliation': '2University of Gothenburg Centre for Person-Centred Care, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}]",Immunity & ageing : I & A,['10.1186/s12979-020-00184-y']
2620,32467735,The effectiveness of cognitive- behavioral therapy on quality of life in women with hypothyroidism in the reproductive age: a randomized controlled trial.,"Background


Worldwide, hypothyroidism affects 3.7% of the population, and is associated with impaired quality of life. This study aimed to evaluate the effect of cognitive- behavioral therapy (CBT) on the quality of life in women with hypothyroidism.
Methods


96 women with hypothyroidism randomly allocated into two groups: CBT group ( n  = 48) and control group (n = 48). Women in the CBT group were classified into four sub-groups of 12, and each sub-group received eight sessions of counseling (each session lasting 90 min). We collected data using a demographic questionnaire and the 36-Item Short Form Health Survey (SF 36) for measuring the quality of life. We used the independent t-test, chi-square test and ANCOVA to analyze the data.
Results


Five women from each group withdrew from the study, leaving 43 women in each group. The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant. The scores on emotional health, emotional health problems, energy and emotions, and general health were significantly better in the CBT group than those in the control group ( p  < 0.05).
Conclusion


Counseling using CBT can improve some aspects of quality of life, including emotional health, emotional health problems, energy and general health in patients with hypothyroidism.
Trial registration number


Iranian Registry for Clinical Trials: 20190323043101 N1. https://www.irct.ir/.",2020,"The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant.","['patients with hypothyroidism', '96 women with hypothyroidism', 'women with hypothyroidism', 'women with hypothyroidism in the reproductive age', 'Five women from each group withdrew from the study, leaving 43 women in each group']","['CBT', 'cognitive- behavioral therapy (CBT', 'cognitive- behavioral therapy']","['quality of life', 'physical functioning, physical health problems, social functioning and pain', 'quality of life, including emotional health, emotional health problems, energy and general health', 'emotional health, emotional health problems, energy and emotions, and general health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446390', 'cui_str': 'Physical health problems'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",96.0,0.0749025,"The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant.","[{'ForeName': 'Sohaila', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': '1MS. c Candidate in Midwifery Department, Reproductive Health Promotion Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': '2PhD in Community Nutrition, Associate Professor in Midwifery Department, Menopause Andropause Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': '3PhD of Biostatistics, Assistant Professor, Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': '4Associate Professor of Clinical Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Homaira', 'Initials': 'H', 'LastName': 'Rashidi', 'Affiliation': '5Associate Professor in Endocrinology Department, Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Thyroid research,['10.1186/s13044-020-00080-z']
2621,32467763,The effects of hypoxia on muscle deoxygenation and recruitment in the flexor digitorum superficialis during submaximal intermittent handgrip exercise.,"Background


Decreased oxygenation of muscle may be accentuated during exercise at high altitude. Monitoring the oxygen saturation of muscle (SmO 2 ) during hand grip exercise using near infrared spectroscopy during acute exposure to hypoxia could provide a model for a test of muscle performance without the competing cardiovascular stresses that occur during a cycle ergometer or treadmill test. The purpose of this study was to examine and compare acute exposure to normobaric hypoxia versus normoxia on deoxygenation and recruitment of the flexor digitorum superficialis (FDS) during submaximal intermittent handgrip exercise (HGE) in healthy adults.
Methods


Twenty subjects (11 M/9 F) performed HGE at 50% of maximum voluntary contraction, with a duty cycle of 2 s:1 s until task failure on two occasions one week apart, randomly assigned to normobaric hypoxia (FiO 2  = 12%) or normoxia (FiO 2  = 21%). Near-infrared spectroscopy monitored SmO 2 , oxygenated (O 2 Hb), deoxygenated (HHb), and total hemoglobin (tHb) over the FDS. Surface electromyography derived root mean square and mean power frequency of the FDS.
Results


Hypoxic compared to normoxic HGE induced a lower FDS SmO 2  (63.8 ± 2.2 vs. 69.0 ± 1.5,  p  = 0.001) and both protocols decreased FDS SmO 2  from baseline to task failure. FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz,  p  = 0.04) and both decreased mean power frequency from the first contractions to task failure ( p  = 0.000). Under both hypoxia and normoxia, HHb, tHb and root mean square increased from baseline to task failure whereas O 2 Hb decreased and then increased during HGE. Arterial oxygen saturation via pulse oximetry (SpO 2 ) was lower during hypoxia compared to normoxia conditions ( p  = 0.000) and heart rate and diastolic blood pressure only demonstrated small increases. Task durations and the tension-time index of HGE did not differ between normoxic and hypoxic trials.
Conclusion


Hypoxic compared to normoxic HGE decreased SmO 2  and induced lower mean power frequency in the FDS, during repetitive hand grip exercise however did not result in differences in task durations or tension-time indices. The fiber type composition of FDS, and high duty cycle and intensity may have contributed greater dependence on anaerobiosis.",2020,"FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz,  ",['healthy adults'],"['submaximal intermittent handgrip exercise (HGE', 'hand grip exercise', 'normoxic HGE', 'normobaric hypoxia versus normoxia', 'hypoxia']","['FDS mean power frequency', 'oxygenated (O 2 Hb), deoxygenated (HHb), and total hemoglobin (tHb', 'hypoxia and normoxia, HHb, tHb and root mean square', 'task durations or tension-time indices', 'heart rate and diastolic blood pressure', 'Arterial oxygen saturation via pulse oximetry (SpO 2 ', 'Task durations and the tension-time index of HGE']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.051533,"FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz,  ","[{'ForeName': 'Hayley J', 'Initials': 'HJ', 'LastName': 'Nell', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Castelli', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Bertani', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Aaron A', 'Initials': 'AA', 'LastName': 'Jipson', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Sean F', 'Initials': 'SF', 'LastName': 'Meagher', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Luana T', 'Initials': 'LT', 'LastName': 'Melo', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zabjek', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'W Darlene', 'Initials': 'WD', 'LastName': 'Reid', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00163-2']
2622,32467770,Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial.,"Background


Mobility problems are present in 70-80% of stroke survivors and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England.
Methods


This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over 6 weeks (3 × 30 min per week, 6 supervised (physiotherapist/research associate)/12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, 6 weeks and 10 weeks and description of participant, provider and clinical therapists' experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants.
Discussion


The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial.
Trial registration


Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018.",2020,This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England.,"['community-dwelling stroke survivors (ACTIVATE', 'home and community settings in North East England', '60 participants over 15\u2009months from community stroke services in the North East of England']","['Auditory rhythmic cueing (ARC', '18 auditory rhythmical cueing (ARC) treatment sessions', 'auditory rhythmical cueing (ARC) intervention', 'gait exercise training programme', 'Auditory rhythmical cueing']",['gait and physical activity'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587667', 'cui_str': 'Stroke service'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.158237,This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCue', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Din', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hunter', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': '5Auckland University of Technology, 55 Wellesley St E, Auckland, 1010 New Zealand.'}, {'ForeName': 'Christopher I M', 'Initials': 'CIM', 'LastName': 'Price', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Moore', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00605-1']
2623,32467805,Management of Gunshot Injuries of Mandible with Open Reduction and Internal Fixation versus Closed Reduction and Maxillo-mandibular Fixation.,"Background/objectives Gunshot injuries are known to cause severe morbidity and mortality when facial regions are involved. Management of the gunshot wounds of the face comprises of securing an airway, controlling hemorrhage, identifying other injuries and definite repair of the traumatic facial deformities. The objective of the present study was to compare the clinical outcome (infection and nonunion) of open reduction and internal fixation versus closed reduction and maxillo-mandibular fixation (CR-MMF) in the treatment of gunshot injuries of the mandible. Materials & methods This study was conducted at Oral and Maxillofacial Surgery Department of Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences Islamabad, Pakistan. Ninety gunshot mandibular fractures were randomly allocated in two equal groups. In group-A, 45 patients were treated by open reduction and internal fixation while in group-B, 45 patients were also managed by closed reduction and maxillo-mandibular fixation. Post-operative complications (infection, non-union) were evaluated clinically and radiographically in both groups. Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044. Whereas non-union was more in closed reduction (15.6%) as compared to open reduction and internal fixation group (2.2%) with a significant p-value 0.026. Conclusion Both the treatment modalities can be used in the management of gunshot injuries of mandible and there is need for further studies to have clear guideline in this regard in best interest of patients, community and health care providers.",2020,Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044.,"['Ninety gunshot mandibular fractures', 'Oral and Maxillofacial Surgery Department of Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences Islamabad, Pakistan', 'gunshot injuries of the mandible']","['open reduction and internal fixation versus closed reduction and maxillo-mandibular fixation (CR-MMF', 'Internal Fixation versus Closed Reduction and Maxillo-mandibular Fixation']",['clinical outcome (infection and nonunion'],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043252', 'cui_str': 'Gunshot wound'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",45.0,0.0151286,Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044.,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Muddassar', 'Affiliation': 'Oral Medicine / Oral and Maxillofacial Surgery, Islam Dental College, Sialkot, PAK.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Arshad', 'Affiliation': 'Oral and Maxillofacial Surgery, Bahria University Medical and Dental College, Karachi, PAK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rabbani', 'Affiliation': 'Oral Pathology, Sharif Medical and Dental College, Lahore, PAK.'}, {'ForeName': 'Imran S', 'Initials': 'IS', 'LastName': 'Qureshi', 'Affiliation': 'Operative Dentistry, Frontier Medical and Dental College, Abbottabad, PAK.'}, {'ForeName': 'Imran K', 'Initials': 'IK', 'LastName': 'Khattak', 'Affiliation': 'Community Dentistry, Frontier Medical and Dental College, Abbottabad, PAK.'}, {'ForeName': 'Zahoor', 'Initials': 'Z', 'LastName': 'Rana', 'Affiliation': 'Oral and Maxillofacial Surgery, Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences (PIMS), Islamabad, PAK.'}]",Cureus,['10.7759/cureus.7830']
2624,32467815,Comparison of Ureteroscopic Pneumatic Lithotripsy and Extracorporeal Shock Wave Lithotripsy for Proximal Ureteral Calculi.,"Objective The goal of this study was to compare the effectiveness and complications of ureteroscopic pneumatic lithotripsy (URS) and extracorporeal shock wave lithotripsy (SWL) in the management of patients with proximal ureteral stones. Methods In this trial, 150 patients presenting with proximal ureteral stones at the Department of Urology of Nishter Hospital Multan from November 2018 to November 2019 were allocated 1:1 to undergo URS or SWL. The presence of stone fragments <4 mm on follow-up was regarded as being stone free. The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys. Results A total of 75 patients each underwent URS and SWL. The mean procedure times for SWL and URS were 61.61± 3.21 and 85.01±6.75 minutes, respectively (P=0.000), and the mean numbers of procedures were 1.51±0.49 and 1.01±0.42, respectively (P=0.000). Stone-free rates after the first, second, and third sessions of SWL were 64%, 77.3%, and 94.7%, respectively, whereas stone-free rates after the first, second, and third sessions of URS were 86.7%, 92%, and 100%, respectively. Rates of stone retropulsion into the kidneys in the SWL and URS groups were 0% and 6.7%, respectively (P=0.000). Conclusion Compared with SWL, URS had significantly higher stone-free rates in patients with proximal ureteral stones. Treatment costs and hospital stay were lower in the SWL group, whereas complication rates were comparable.",2020,"The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys.","['patients with proximal ureteral stones', '150 patients presenting with proximal ureteral stones at the Department of Urology of Nishter Hospital Multan from November 2018 to November 2019', '75 patients each underwent URS and SWL', 'Proximal Ureteral Calculi']","['SWL, URS', 'URS or SWL', 'Ureteroscopic Pneumatic Lithotripsy and Extracorporeal Shock Wave Lithotripsy', 'ureteroscopic pneumatic lithotripsy (URS) and extracorporeal shock wave lithotripsy (SWL']","['complication rates', 'Treatment costs and hospital stay', 'stone-free rates', 'mean numbers of procedures', 'mean procedure times for SWL and URS', 'stone retropulsion into the kidneys', 'Stone-free rates', 'Rates of stone retropulsion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",150.0,0.0392211,"The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys.","[{'ForeName': 'Muhammad Fazal', 'Initials': 'MF', 'LastName': 'Ur Rehman', 'Affiliation': 'Urology, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Adnan', 'Affiliation': 'Urology, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Urology, University of Lahore Teaching Hospital, Lahore, PAK.'}, {'ForeName': 'Fawad', 'Initials': 'F', 'LastName': 'Humayun Akhtar', 'Affiliation': 'Urology, Children Hospital and Institute of Child Health, Lahore, PAK.'}, {'ForeName': 'Naseem', 'Initials': 'N', 'LastName': 'Javed', 'Affiliation': 'Paediatric Urology, Children Hospital and Institute of Child Health, Lahore, PAK.'}, {'ForeName': 'Farman', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine, District Headquarter Hospital, Khanewal, PAK.'}]",Cureus,['10.7759/cureus.7840']
2625,32467832,Potions for Emotions: Do self-reported individual differences in negative-emotional drinking predict alcohol consumption in the laboratory following exposure to a negative experience?,"Aims


Research suggests that self-reports on inferred motives for engaging in behavior may be biased by limited introspective access into such processes. Self-reports on observable behavior, on the other hand, may generate more accurate responses with which to predict behavior. The aim was to determine whether drinking alcohol in response to negative emotion ( negative-emotional drinking; NED ) is best predicted by self-reported individual differences in ( a ) motives to use alcohol to regulate negative emotion, or ( b ) the degree to which negative emotion impacts alcohol consumption (observable behavior).
Methods


Thirty-nine beer drinkers completed the Drinking Motives Questionnaire-Revised (DMQ-R) which measures individual differences in drinking motives, including the motive to regulate negative emotion (coping motives). They also completed a new self-report measure of the degree to which negative emotion impacts their alcohol consumption. Participants were randomized into a negative emotion induction condition or control condition and completed a subsequent alcohol consumption task to serve as a behavioral measure of drinking in response to negative emotion.
Results


Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r  = 0.72,  p  = <.001) and not in the control condition ( r  = 0.09,  p  = .696). Self-reported coping motives did not predict alcohol consumption in either condition.
Conclusions


The amount of alcohol consumed in response to negative emotion is best predicted by self-reports on observable behavior, and not by self-reports on drinking motives.",2020,"Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r  = 0.72,  p  = <.001) and not in the control condition ( r  = 0.09,  p  = .696).",[],['negative emotion induction condition or control condition and completed a subsequent alcohol consumption task to serve as a behavioral measure of drinking in response to negative emotion'],['Drinking Motives Questionnaire-Revised (DMQ-R'],[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.00916342,"Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r  = 0.72,  p  = <.001) and not in the control condition ( r  = 0.09,  p  = .696).","[{'ForeName': 'Henry R T', 'Initials': 'HRT', 'LastName': 'Austin', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-Lab, Universiteit van Amsterdam, Netherlands.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-Lab, Universiteit van Amsterdam, Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'MacLeod', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}]",Addictive behaviors reports,['10.1016/j.abrep.2019.100243']
2626,32468087,Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.,"PURPOSE


Nangibotide is a specific TREM-1 inhibitor that tempered deleterious host-pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.
METHODS


This was a multicenter randomized, double-blind, two-stage study. Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days. Safety primary outcomes were adverse events (AEs), whether serious or not, and death. Exploratory endpoints evaluated nangibotide effects on pharmacodynamics, organ function, and mortality, and were analyzed according to baseline sTREM-1 concentrations.
RESULTS


Forty-nine patients were randomized. All treatment emergent AEs (TEAEs) were collected until Day 28. No significant differences were observed in TEAEs between treatment groups. No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported. Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent. Nangibotide did not significantly affect pharmacodynamic markers. Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant). This pattern was similar to organ support end points.
CONCLUSION


No significant increases in TEAEs were detected in nangibotide-treated patients versus placebo. These results encourage further evaluation of nangibotide and further exploration of plasma sTREM-1 concentrations as a predictive efficacy biomarker.",2020,No significant differences were observed in TEAEs between treatment groups.,"['septic shock patients', 'patients with septic shock', 'Forty-nine patients were randomized']","['Nangibotide', 'continuous infusion of nangibotide', 'placebo']","['Nangibotide pharmacokinetics', 'nangibotide effects on pharmacodynamics, organ function, and mortality', 'TEAEs', 'pharmacodynamic markers', 'SOFA score LS mean change (±\u2009SE', 'adverse events (AEs), whether serious or not, and death']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",49.0,0.585864,No significant differences were observed in TEAEs between treatment groups.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical ICU Department and Inserm CIC1435 & UMR1092, CRICS-TRIGGERSEP Network, CHU Limoges, Limoges, France. b.francois@unilim.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""ICU Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Medical ICU, Cochin Hotel-Dieu, AP-HP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'ICU Department, Clinique St. Pierre, Ottignies, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Gibot', 'Affiliation': 'Medical ICU Department, Hospital Central, CHU Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Derive', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Olivier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Cuvier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Witte', 'Affiliation': 'Helion Pharma, Schriesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'ICU Department, Radboudumc Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vandenhende', 'Affiliation': 'ClinBay SPRL, Baisy-Thy, Belgium.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Garaud', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'ICU Department, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Salcedo-Magguilli', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}]",Intensive care medicine,['10.1007/s00134-020-06109-z']
2627,32468131,Risk factors of impairment of shoulder function after axillary dissection for breast cancer.,"OBJECTIVES


Postoperative shoulder joint dysfunction has been observed at a certain rate after breast cancer surgery with axillary lymph node dissection. The purposes of this study were to verify the feasibility and effects of home-based exercise using a DVD and clarify the target of intensive intervention with physiotherapy by identifying the factors that cause postoperative shoulder dysfunction.
METHODS


The study comprised 237 female patients who underwent breast cancer surgery with axillary lymph node dissection, whose data were acquired until 3 months postoperatively. All patients were instructed to exercise at home using a DVD. Range of motion (ROM) of shoulder flexion and abduction and the disability of the arm, shoulder, and hand (DASH) score were measured before surgery, 1 week and 1, 2, and 3 months after surgery. As factors influencing the recovery of shoulder ROM at 3 months after surgery, the presence or absence of radiation and factors up to 1 month after surgery (age, body mass index, the relationship between operated side and dominant side of the hand, treatment modalities, and complications).
RESULTS


Shoulder ROM and DASH scores had gradually recovered from 1 week to 3 months postoperatively. As the results of the multivariate analysis, the factors that were associated with the recovery of ROM of shoulder flexion at 3 months were the side of surgery corresponding to the dominant hand (negative factor) and the presence of paresthesia at 1 week postoperatively (positive factor) (p < 0.05). Radiation therapy and the side of surgery corresponding to the dominant hand were negative factors for the recovery of shoulder abduction (p < 0.01). Regarding the feasibility of the home exercise, 214/229 (93.4%), 172/210 (81.9%), and 139/206 (67.5%) of patients performed exercise at least once a day at 1, 2, and 3 months after surgery, respectively.
CONCLUSION


Our result indicated that the side of surgery corresponding to the dominant hand was the inhibiting factor for recovery for both shoulder flexion and abduction at 3 months after surgery. Home-based exercise with DVD was considered feasible. For the verification of this effectiveness, a randomized control study should be planned in the future.",2020,Radiation therapy and the side of surgery corresponding to the dominant hand were negative factors for the recovery of shoulder abduction (p < 0.01).,"['breast cancer', 'breast cancer surgery with axillary lymph node dissection', '237 female patients who underwent breast cancer surgery with axillary lymph node dissection, whose data were acquired until 3\xa0months postoperatively']","['Radiation therapy', 'home-based exercise']","['Shoulder ROM and DASH scores', 'presence of paresthesia', 'Range of motion (ROM) of shoulder flexion and abduction and the disability of the arm, shoulder, and hand (DASH) score', 'recovery of shoulder ROM', 'recovery of ROM of shoulder flexion']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}]",237.0,0.0601749,Radiation therapy and the side of surgery corresponding to the dominant hand were negative factors for the recovery of shoulder abduction (p < 0.01).,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kikuuchi', 'Affiliation': 'Department of Rehabilitation Medicine, National Hospital Organization Shikoku Cancer Center, Ko-160, Minamiumemoto-cho, Matsuyama City, 7910280, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Akezaki', 'Affiliation': 'Division of Physical Therapy, Kochi Professional University of Rehabilitation, Kochi, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nakata', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Yamashita', 'Affiliation': 'Division of Clinical Biostatistics, Clinical Research Center, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Tominaga', 'Affiliation': 'Department of Rehabilitation Medicine, National Hospital Organization Shikoku Cancer Center, Ko-160, Minamiumemoto-cho, Matsuyama City, 7910280, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Rehabilitation Medicine, National Hospital Organization Shikoku Cancer Center, Ko-160, Minamiumemoto-cho, Matsuyama City, 7910280, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Hamada', 'Affiliation': 'Department of Rehabilitation Medicine, National Hospital Organization Shikoku Cancer Center, Ko-160, Minamiumemoto-cho, Matsuyama City, 7910280, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Aogi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Sugihara', 'Affiliation': 'Department of Rehabilitation Medicine, National Hospital Organization Shikoku Cancer Center, Ko-160, Minamiumemoto-cho, Matsuyama City, 7910280, Japan. sugihara.shinsuke.rk@mail.hosp.go.jp.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05533-7']
2628,32468132,Can-Pain-a digital intervention to optimise cancer pain control in the community: development and feasibility testing.,"PURPOSE


To develop a novel digital intervention to optimise cancer pain control in the community. This paper describes intervention development, content/rationale and initial feasibility testing.
METHODS


Determinants of suboptimal cancer pain management were characterised through two systematic reviews; patient, caregiver and healthcare professional (HCP) interviews (n = 39); and two HCP focus groups (n = 12). Intervention mapping was used to translate results into theory-based content, creating the app ""Can-Pain"". Patients with/without a linked caregiver, their general practitioners and community palliative care nurses were recruited to feasibility test Can-Pain over 4 weeks.
RESULTS


Patients on strong opioids described challenges balancing pain levels with opioid intake, side effects and activities and communicating about pain management problems with HCPs. Can-Pain addresses these challenges through educational resources, contemporaneous short-acting opioid tracking and weekly patient-reported outcome monitoring. Novel aspects of Can-Pain include the use of contemporaneous breakthrough analgesic reports as a surrogate measure of pain control and measuring the level at which pain becomes bothersome to the individual. Patients were unwell due to advanced cancer, making recruitment to feasibility testing difficult. Two patients and one caregiver used Can-Pain for 4 weeks, sharing weekly reports with four HCPs. Can-Pain highlighted unrecognised problems, promoted shared understanding about symptoms between patients and HCPs and supported shared decision-making.
CONCLUSIONS


Preliminary testing suggests that Can-Pain is feasible and could promote patient-centred pain management. We will conduct further small-scale evaluations to inform a future randomised, stepped-wedge trial.
TRIAL REGISTRATION


Qualitative research: ClinicalTrials.gov, reference NCT02341846 Feasibility study: NIHR CPMS database ID 34172.",2020,"Can-Pain highlighted unrecognised problems, promoted shared understanding about symptoms between patients and HCPs and supported shared decision-making.
","['optimise cancer pain control in the community', 'Patients were unwell due to advanced cancer', 'Patients with/without a linked caregiver, their general practitioners and community palliative care nurses', 'Determinants of suboptimal cancer pain management were characterised through two systematic reviews; patient, caregiver and healthcare professional (HCP) interviews (n\u2009=\u200939); and two HCP focus groups (n\u2009=\u200912']",['novel digital intervention'],[],"[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3714595', 'cui_str': 'Palliative care nurse'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],2.0,0.0348938,"Can-Pain highlighted unrecognised problems, promoted shared understanding about symptoms between patients and HCPs and supported shared decision-making.
","[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Academic Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Room 1:020, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. rosalindadam@abdn.ac.uk.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bond', 'Affiliation': 'Academic Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Burton', 'Affiliation': 'Academic Unit of Primary Medical Care, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Health Psychology, Radboud University Medical Centre, Radboud Institute of Health Sciences, IQ Healthcare, Nijmegen, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Academic Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05510-0']
2629,32468174,Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study.,"INTRODUCTION AND HYPOTHESIS


The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension.
METHODS


A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score).
RESULTS


We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23-96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien-Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group.
CONCLUSIONS


Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.",2020,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"['patient preference study after randomising initial 6 participants', 'Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included', '50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016', 'women with apical prolapse']","['Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension', 'Hysterectomy with uterosacral suspension or Uphold™ hysteropexy']","['composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes', 'objective apical outcomes; the incidence of stage 2 prolapse', 'quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score', 'absence of stage ≥2 apical prolapse', 'objective and subjective cure', 'objective and subjective cure rates', 'composite cure rate', 'surgical complications']","[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.187724,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"[{'ForeName': 'Mugdha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia. doc.mugdha@gmail.com.'}, {'ForeName': 'Natharnia', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'St. Vincents Clinic, UNSW Sydney Australia, Sydney, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosamilia', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}]",International urogynecology journal,['10.1007/s00192-020-04328-y']
2630,32468187,Effect of Metformin vs. Placebo in Combination with Insulin Analogues on Bone Markers P1NP and CTX in Patients with Type 2 Diabetes Mellitus.,"Preclinical studies have shown a potential osteoanabolic effect of metformin but human studies of how metformin affects bone turnover are few. A post hoc sub-study analysis of an 18-month multicenter, placebo-controlled, double-blinded trial in type 2 diabetes mellitus (T2DM), randomizing participants to metformin versus placebo both in combination with different insulin analogue regimens (Metformin + Insulin vs. Placebo + Insulin). Patients were not treatment naive at baseline, 83% had received metformin, 69% had received insulin, 57.5% had received the combination of metformin and insulin before entering the study. Bone formation and resorption were assessed by measuring, N-terminal propeptide of type I procollagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) at baseline and end of study. The influence of gender, age, smoking, body mass index (BMI), T2DM duration, glycosylated hemoglobin A1c (HbA1c), c-reactive protein (CRP) and insulin dosage was also included in the analyses. The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial. P1NP increased less in the Metformin + Insulin compared to the placebo + insulin group (p = 0.001) (between group difference change), while the increases in CTX levels (p = 0.11) were not different. CRP was inversely associated (p = 0.012) and insulin dosage (p = 0.011) was positively related with change in P1NP levels. BMI (p = 0.002) and HbA1C (p = 0.037) were inversely associated with change in CTX levels. During 18 months of treatment with metformin or placebo, both in combination with insulin, bone turnover increased in both groups. But the pattern was different as the bone formation marker (P1NP) increased less during Metformin + Insulin treatment, while change in bone resorption (CTX) was not significantly different between the two groups.",2020,The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial.,"['Patients with Type 2 Diabetes Mellitus', 'type 2 diabetes mellitus (T2DM), randomizing participants to']","['metformin versus placebo both in combination with different insulin analogue regimens (Metformin\u2009+\u2009Insulin vs. Placebo\u2009+\u2009Insulin', 'metformin and insulin', 'Metformin vs. Placebo', 'metformin', 'metformin or placebo', 'Insulin Analogues', 'placebo']","['Bone Markers P1NP and CTX', 'telopeptide of type I collagen (CTX', 'CRP', 'bone formation marker (P1NP', 'CTX levels', 'BMI', 'gender, age, smoking, body mass index (BMI), T2DM duration, glycosylated hemoglobin A1c (HbA1c), c-reactive protein (CRP) and insulin dosage', 'levels of bone formation marker P1NP and bone resorption marker CTX', 'Bone formation and resorption', 'bone resorption (CTX', 'P1NP levels', 'bone turnover']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.227366,The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial.,"[{'ForeName': 'Azra Karahasanovic', 'Initials': 'AK', 'LastName': 'Nordklint', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark. azrica87@gmail.com.'}, {'ForeName': 'Thomas Peter', 'Initials': 'TP', 'LastName': 'Almdal', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Departments of Clinical Medicine and Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lundby-Christensen', 'Affiliation': 'Steno Diabetes Center Zealand, Holbæk, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Trine W', 'Initials': 'TW', 'LastName': 'Boesgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Breum', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Birthe', 'Initials': 'B', 'LastName': 'Gade-Rasmussen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simone B', 'Initials': 'SB', 'LastName': 'Sneppen', 'Affiliation': 'Department of Medicine, Gentofte, Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Endocrinology, Bispebjerg, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Perrild', 'Affiliation': 'Department of Endocrinology, Bispebjerg, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Zealand, Holbæk, Denmark.'}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Vestergaard', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Lund', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Eiken', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}]",Calcified tissue international,['10.1007/s00223-020-00711-5']
2631,32468267,Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157).,"The potential benefit of endometrial scratching (ES) on embryo implantation is still a controversial subject. At present, the single retrospective study in egg donor IVF cycles concluded that ES has no beneficial effect. Our objective was to determine if there are differences in clinical pregnancy rates (CPR) in egg donor cycles when an ES is performed. This is a randomized controlled trial (RCT) in egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid. Three hundred fifty-two patients were included in total. One hundred sixty-one patients completed the protocol in group A and 172 patients in group B. Patients allocated to group A received an ES in the luteal phase of the cycle preceding the embryo transfer cycle. Group B patients did not receive any intervention. Primary outcome of this RCT was CPR. Secondary outcomes were implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR). CPR was 104 of 161 (64.6%) in group A and 102 of 172 (59.3%) in group B (RR 1.09, 95% confidence interval (CI) (0.92-1.29); p = 0.378). OPR, MR, MulPR, and LBR were also comparable. No major complications were detected after ES and pregnancy complications were comparable. Our results show that there is no beneficial role of ES in egg donor IVF cycles, considering these patients as the ideal model as they share homogeneous embryo quality and endometrial preparation protocols. This trial was registered on April 5, 2017, as the ENDOSCRATCH trial (NCT03108157).",2020,No major complications were detected after ES and pregnancy complications were comparable.,"['Patients Undergoing Egg Donor', 'egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid', 'Three hundred fifty-two patients were included in total']","['ES', 'endometrial scratching (ES']","['pregnancy complications', 'Clinical Pregnancy Rates', 'CPR', 'OPR, MR, MulPR, and LBR', 'clinical pregnancy rates (CPR', 'major complications', 'implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029975', 'cui_str': 'Egg donor'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",352.0,0.354115,No major complications were detected after ES and pregnancy complications were comparable.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo Rodriguez', 'Affiliation': 'ProcreaTec Fertility Center, Manuel de Falla 6, 28036, Madrid, Spain. endoscratchtrial@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de la Fuente Bitaine', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, Avda. Andalucia s/n, Madrid, Spain.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Spies', 'Affiliation': 'ProcreaTec Fertility Center, Manuel de Falla 6, 28036, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora', 'Affiliation': 'Clinical Research Unit (imas12-CIBERESP), University Hospital 12 de Octubre, Avda. Andalucia s/n, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galindo', 'Affiliation': 'Fetal Medicine Unit - Maternal and Child Health and Development Network (Red SAMID-RD12/0026/0016), Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, 12 de Octubre Research Institute (imas12), Complutense University of Madrid, Avda. Andalucia s/n, Madrid, Spain.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00204-8']
2632,32468396,Anxiety and Depression Reduction as Distal Outcomes of a College Transition Readiness Program for Adults with Autism.,"Young adults with autism spectrum disorder (ASD) experience increased rates of anxiety and depression which can impact academic success. The Stepped Transition in Education Program for Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD improve their adjustment to postsecondary education. We aimed to determine if STEPS had an effect on anxiety and depression. Treatment-seeking adults with ASD (n = 32; Mage = 19.74) were randomized to STEPS or transition as usual (TAU; i.e., waitlist control group). STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist. Anxiety symptoms did not significantly change. Results suggest that transition support for young people with ASD may improve mental health.",2020,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"['Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD', 'Treatment-seeking adults with ASD (n\u2009=\u200932; Mage\u2009=\u200919.74', 'Young adults with autism spectrum disorder', 'Adults with Autism', 'young people with ASD']","['STEPS', 'College Transition Readiness Program']","['Anxiety symptoms', 'Anxiety and Depression Reduction', 'mental health', 'rates of anxiety and depression', 'anxiety and depression', 'depressive symptoms']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0373388,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"[{'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA. nncapriola@crimson.ua.edu.'}, {'ForeName': 'Alexis M', 'Initials': 'AM', 'LastName': 'Brewe', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Golt', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04549-6']
2633,32468413,The COVID-19 pandemic: is our medicine still evidence-based?,"There is no randomized controlled trial that demonstrated the efficacy of antiviral therapy against COVID-19 yet. However, physicians are prescribing different drugs to a large part of COVID-19 population in the hope they will cure them. This does not reflect the evidence-based medicine approach. What we need is more evidence-based knowledge about what routine care practices we should to apply to ameliorate symptoms of patients and fight COVID-19 pathology.",2020,What we need is more evidence-based knowledge about what routine care practices we should to apply to ameliorate symptoms of patients and fight COVID-19 pathology.,[],[],[],[],[],[],,0.175249,What we need is more evidence-based knowledge about what routine care practices we should to apply to ameliorate symptoms of patients and fight COVID-19 pathology.,"[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Deana', 'Affiliation': 'Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Academic Hospital of Udine, Udine, Italy. deana.cristian@gmail.com.'}]",Irish journal of medical science,['10.1007/s11845-020-02258-8']
2634,32468447,Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ®  (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial.,"BACKGROUND


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetics, glucodynamics, safety, and tolerability of URLi and Humalog ®  in patients with type 1 diabetes mellitus (T1DM).
METHODS


This was a phase I, two-period, randomised, double-blind, crossover glucose clamp study in younger adult (aged 18-45 years; n = 41) and elderly (aged ≥65 years; n = 39) patients with T1DM. At each dosing visit, patients received either URLi or Humalog (15 units subcutaneously) followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.
RESULTS


Insulin lispro appeared in serum 6 min faster, and exposure was 7.2-fold greater over the first 15 min postdose with URLi versus Humalog in both age groups. Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups. Onset of insulin action was 11-12 min faster, and insulin action was 3-fold greater over the first 30 min postdose with URLi versus Humalog in both age groups. Insulin action beyond 4 h postdose was 44-54% lower, and duration of action was reduced by 34-44 min with URLi versus Humalog in both age groups. Overall exposure and total insulin action remained similar for both treatments. URLi and Humalog were well tolerated.
CONCLUSION


In patients with T1DM, URLi showed ultra-rapid pharmacokinetics and glucodynamics, with the differences between URLi and Humalog in elderly patients mirroring those in younger adults. ClinicalTrials.gov identifier: NCT03166124.",2020,"Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups.","['patients with T1DM', 'Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus', 'younger adult (aged 18-45\xa0years; n\xa0=\xa041) and elderly (aged ≥65\xa0years; n\xa0=\xa039', 'elderly patients mirroring those in younger adults', 'patients with type 1 diabetes mellitus (T1DM']","['URLi or Humalog (15 units subcutaneously) followed by a 10\xa0h automated euglycaemic clamp procedure', 'URLi and Humalog ®', 'Ultra\xa0Rapid Lispro (URLi) versus Humalog ®  (Lispro', 'Ultra\xa0rapid lispro (URLi']","['ultra-rapid pharmacokinetics and glucodynamics', 'insulin action', 'tolerated', 'exposure duration', 'Serum insulin lispro and blood glucose', 'duration of action', 'Onset of insulin action', 'serum 6\xa0min faster, and exposure', 'Overall exposure and total insulin action', 'Insulin action', 'pharmacokinetics, glucodynamics, safety, and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",39.0,0.0923738,"Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups.","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. linnebjerg_helle@lilly.com.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Herbrand', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00903-0']
2635,32468448,"Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ®  (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study.","BACKGROUND AND OBJECTIVE


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the insulin lispro pharmacokinetics and glucodynamics, safety and tolerability of URLi and Humalog ®  after a single subcutaneous dose in patients with type 2 diabetes mellitus (T2DM).
METHODS


This was a phase I, randomised, two-period, two-treatment, double-blind, crossover study in 38 patients with T2DM. At each dosing visit, patients received either 15 units of URLi or Humalog, followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.
RESULTS


Insulin lispro appeared in the serum 5 min faster (p < 0.0001) and exposure was 6.4-fold greater in the first 15 min (p < 0.0001) with URLi versus Humalog. Exposure beyond 3 h postdose was 26% lower and the duration of exposure was 51 min shorter with URLi versus Humalog. Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog. Insulin action beyond 4 h postdose was 20% lower (p = 0.0099) with URLi versus Humalog. Overall insulin lispro exposure and total glucose infused were similar for URLi and Humalog. Both treatments were well tolerated.
CONCLUSIONS


This is the first study to investigate URLi in patients with T2DM using a euglycaemic clamp procedure. URLi demonstrated ultra-rapid pharmacokinetics and glucodynamics in patients with T2DM. CLINICALTRIALS.
GOV IDENTIFIER


NCT03305822.",2020,Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog.,"['patients with T2DM using a euglycaemic clamp procedure', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', '38 patients with T2DM']","['15 units of URLi or Humalog, followed by a 10\xa0h automated euglycaemic clamp procedure', 'URLi and Humalog ®', 'URLi', 'Ultra Rapid Lispro (URLi) versus Humalog ®  (Lispro']","['Overall insulin lispro exposure and total glucose', 'insulin lispro pharmacokinetics and glucodynamics, safety and tolerability', 'insulin action', 'duration of exposure', 'Serum insulin lispro and blood glucose', 'tolerated', 'Onset of insulin action', 'Insulin lispro', 'Insulin action beyond 4\xa0h postdose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",38.0,0.0565095,Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA. leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Hermanski', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Nosek', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00901-2']
2636,32468579,Talazoparib Exposure-Efficacy Analysis in Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA Trial.,"In the phase 3 EMBRACA trial, treatment with the poly(ADP-ribose) polymerase inhibitor, talazoparib, led to significantly improved progression-free survival (PFS) compared with chemotherapy (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P < .0001). We conducted an exposure-efficacy analysis using EMBRACA data from 285 patients who were treated with talazoparib and had available pharmacokinetic parameters to evaluate the effect of talazoparib exposure (time-varying average talazoparib concentration [C avg,t  ]) and other baseline variables on PFS. Graphical examination of the relationship between C avg,t  and PFS and a Cox proportional model were used. Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS. The association of talazoparib exposure with PFS (higher exposure, longer PFS) suggests the recommended starting dose of 1 mg once daily (the maximum tolerated dose) is appropriate.",2020,"Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS.","['285 patients who were treated with talazoparib and had available pharmacokinetic parameters to evaluate the effect of talazoparib exposure (time-varying average talazoparib concentration [C avg,t  ]) and other baseline variables on PFS', 'Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA Trial']",['Talazoparib'],"['progression-free survival (PFS', 'talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4042960', 'cui_str': 'talazoparib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",285.0,0.192879,"Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS.","[{'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1623']
2637,32468646,"Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease.","OBJECTIVE


Preclinical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, indicates improvement in Alzheimer's disease phenotypes. We investigated whether nilotinib is safe, and detectable in cerebrospinal fluid, and alters biomarkers and clinical decline in Alzheimer's disease.
METHODS


This single-center, phase 2, randomized, double-blind, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers in participants with mild to moderate dementia due to Alzheimer's disease. The diagnosis was supported by cerebrospinal fluid or amyloid positron emission tomography biomarkers. Nilotinib 150 mg versus matching placebo was taken orally once daily for 26 weeks followed by nilotinib 300 mg versus placebo for another 26 weeks.
RESULTS


Of the 37 individuals enrolled, 27 were women and the mean (SD) age was 70.7 (6.48) years. Nilotinib was well-tolerated, although more adverse events, particularly mood swings, were noted with the 300 mg dose. In the nilotinib group, central nervous system (CNS) amyloid burden was significantly reduced in the frontal lobe compared to the placebo group. Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo. Hippocampal volume loss was attenuated (-27%) at 12 months and phospho-tau-181 was reduced at 6 months and 12 months in the nilotinib group.
INTERPRETATION


Nilotinib is safe and achieves pharmacologically relevant cerebrospinal fluid concentrations. Biomarkers of disease were altered in response to nilotinib treatment. These data support a larger, longer, multicenter study to determine the safety and efficacy of nilotinib in Alzheimer's disease. ANN NEUROL 2020.",2020,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[""participants with mild to moderate dementia due to Alzheimer's disease"", ' 27 were women and the mean (SD) age was 70.7 (6.48) years', '37 individuals enrolled', ""Alzheimer's disease""]","['Nilotinib 150 mg versus matching placebo', 'nilotinib 300 mg versus placebo', 'placebo']","['safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers', ""Safety, Tolerability, and Biomarkers in Alzheimer's Disease"", 'Hippocampal volume loss', 'central nervous system (CNS) amyloid burden', 'Cerebrospinal fluid Aβ40', 'safety and efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",27.0,0.589561,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Memory Disorders Program, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Lawler', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Mundel', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yusuf', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'J Nathan', 'Initials': 'JN', 'LastName': 'Starr', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Anjum', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Wangke', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Nuclear Medicine, Washington, DC, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Radiology, MedStar Georgetown Hospital, Washington, DC, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Neuroscience, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}]",Annals of neurology,['10.1002/ana.25775']
2638,32468649,"Pharmacokinetics, Pharmacodynamics, and Safety of the Dual Orexin Receptor Antagonist Lemborexant: Findings From Single-Dose and Multiple-Ascending-Dose Phase 1 Studies in Healthy Adults.","Lemborexant, a dual orexin receptor antagonist, is approved for the treatment of insomnia and is under investigation for treating other sleep disorders. Here we summarize pharmacokinetic, pharmacodynamic, and safety data from 3 randomized, double-blind, placebo-controlled phase 1 studies: single ascending doses in healthy adults (Study 001; 1-200 mg; N = 64), multiple ascending doses in healthy and elderly adults (Study 002; 2.5-75 mg; N = 55), and multiple doses in healthy white and Japanese adults (Study 003; 2.5-25 mg; N = 32). Lemborexant exposure increased with increasing dose. The time to maximum concentration ranged from approximately 1 to 3 hours for the 5- and 10-mg doses. The mean effective half-life was 17 hours for lemborexant 5 mg and 19 hours for lemborexant 10 mg. The plasma concentration at 9 hours postdose was 27% of the maximum concentration following multiple dosing with lemborexant 10 mg. There were no clinically relevant effects on next-morning residual sleepiness (Karolinska Sleepiness Scale, Digital Symbol Substitution Test, Psychomotor Vigilance Test) for doses through 10 mg/day, indicating no effect of residual plasma concentrations on next-day residual effects. Lemborexant was well tolerated across the doses tested. There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety. These results suggest that lemborexant at doses through 25 mg provides an overall pharmacokinetic, pharmacodynamic, and safety profile suitable for obtaining the target pharmacologic effect supporting treatment of insomnia while minimizing residual effects during wake time.",2020,"There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety.","['Healthy Adults', 'healthy adults (Study 001; 1-200\xa0mg; N\xa0=\xa064), multiple ascending doses in healthy and elderly adults (Study 002; 2.5-75\xa0mg; N\xa0=\xa055), and multiple doses in healthy white and Japanese adults (Study 003; 2.5-25\xa0mg; N\xa0=\xa032']","['Lemborexant', 'lemborexant', 'Dual Orexin Receptor Antagonist Lemborexant', 'placebo']","['next-morning residual sleepiness (Karolinska Sleepiness Scale, Digital Symbol Substitution Test, Psychomotor Vigilance Test', 'Pharmacokinetics, Pharmacodynamics, and Safety', 'residual plasma concentrations', 'plasma concentration', 'lemborexant pharmacokinetics, pharmacodynamics, or safety', 'mean effective half-life', 'Lemborexant exposure']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0580197,"There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety.","[{'ForeName': 'Ishani', 'Initials': 'I', 'LastName': 'Landry', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'Eisai Co, Ltd, Koishikawa, Tokyo, Japan.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ferry', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Aluri', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Lalovic', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.817']
2639,32468669,The effects of health belief model-based education and acupressure for coping with premenstrual syndrome on premenstrual symptoms and quality of life: A randomized-controlled trial.,"PURPOSE


This study investigated the effects of health belief model-based education and acupressure for coping with premenstrual syndrome (PMS) on premenstrual symptoms and quality of life.
DESIGN AND METHODS


The sample size was identified as 163 women. While the acupressure education group-administered education and acupressure, the education group-administered only education. No intervention made to the control group.
FINDINGS


There was a significant difference between the pretest and posttest total mean scores of the intervention groups compared with the control group (P < .001).
PRACTICE IMPLICATIONS


The education given to women for coping with PMS and acupressure both reduced premenstrual symptoms and improved quality of life.",2020,"There was a significant difference between the pretest and posttest total mean scores of the intervention groups compared with the control group (P < .001).
",['163 women'],"['acupressure education group-administered education and acupressure, the education group-administered only education', 'health belief model-based education and acupressure']","['premenstrual symptoms and quality of life', 'premenstrual symptoms and improved quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.026958,"There was a significant difference between the pretest and posttest total mean scores of the intervention groups compared with the control group (P < .001).
","[{'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Simsek Kücükkelepce', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}, {'ForeName': 'Sermin', 'Initials': 'S', 'LastName': 'Timur Tashan', 'Affiliation': 'Department of Women Health and Diseases Nursing, Faculty of Nursing, Inonu University, Malatya, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12546']
2640,32468672,Rationale and Study Design of OUTSTEP-HF: A Randomized Controlled Study to Assess the Effect of Sacubitril/Valsartan and Enalapril on Physical Activity measured by Accelerometry in Patients with Heart Failure with Reduced Ejection Fraction.,"AIM


In PARADIGM-HF, sacubitril/valsartan demonstrated superiority to enalapril in reducing mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management. OUTSTEP-HF has been designed to evaluate the effects of sacubitril/valsartan compared with enalapril on non-sedentary daytime physical activity in patients with HFrEF.
METHODS


OUTSTEP-HF is a randomised, actively controlled, double-blind, double-dummy study that plans to enrol 600 ambulatory patients with symptomatic HFrEF in 19 European countries. Patients will be randomised 1:1 to receive sacubitril/valsartan 97/103 mg twice-daily (bid) or enalapril 10 mg bid. The primary objective of the study was to assess changes from baseline (week 0) to week 12 in exercise capacity measured by 6MWT and in daily non-sedentary daytime activity Physical activity and objective sleep parameters will be measured by accelerometry using a wrist worn device, worn continuously from screening (Week -2) until the end-of-study (Week 12). As a co-primary outcome, changes from baseline in sub-maximal exercise capacity will be assessed by the 6-minute walking test. Patient- and physician-reported questionnaires will be used to assess QoL, changes in signs and symptoms of HF and sleep parameters.
CONCLUSION


OUTSTEP-HF will be the largest randomized trial in HF to date to use non-invasive accelerometry to assess whether treatment with sacubitril/valsartan improves patients' daily physical activity and exercise capacity compared with enalapril. This article is protected by copyright. All rights reserved.",2020,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"['Patients with Heart Failure with Reduced Ejection Fraction', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', '600 ambulatory patients with symptomatic HFrEF in 19 European countries']","['Sacubitril/Valsartan and Enalapril', 'sacubitril/valsartan 97/103 mg twice-daily (bid) or enalapril 10 mg bid', 'enalapril', 'sacubitril/valsartan', 'OUTSTEP-HF']","['mortality and morbidity', 'Physical Activity', '6-minute walking test', 'physical activity and quality of life (QoL', ""patients' daily physical activity and exercise capacity"", 'sub-maximal exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",600.0,0.170912,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Division of Nursing Science, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Community Heart Failure Program, Department of Cardiology, Bellvitge University Hospital and Biomedical Research Institute (IDIBELL), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schorr', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ecochard', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rizwan I', 'Initials': 'RI', 'LastName': 'Hussain', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Massimo F', 'Initials': 'MF', 'LastName': 'Piepoli', 'Affiliation': ""Heart Failure Unit, Cardiology Department, G. Da Saliceto Polichirurgico Hospital, Piacenza, University of Parma, and Institute of Life Sciences, Sant'Anna School of Advanced Studies, Pisa, Italy.""}]",European journal of heart failure,['10.1002/ejhf.1919']
2641,32468686,Online video psychoeducation for electroconvulsive therapy in India: A randomized controlled trial.,"Despite its effectiveness, electroconvulsive therapy (ECT) has been widely but diminishingly used in India. The current study evaluated a video psychoeducation on ECT offered to adults in India who screened positive for depression. Participants were randomly assigned to receive either video or brochure psychoeducation. Both video and brochure psychoeducation significantly improved participants' perceptions, knowledge, and willingness to receive ECT with only a few significant differences between the two modalities. Together, these findings suggest that psychoeducation is effective. Video psychoeducation which can be inexpensive and widely distributed may represent an important way to encourage patients to consider ECT as an option.",2020,"Both video and brochure psychoeducation significantly improved participants' perceptions, knowledge, and willingness to receive ECT with only a few significant differences between the two modalities.","['India', 'adults in India who screened positive for depression']","['Video psychoeducation', 'video or brochure psychoeducation', 'Online video psychoeducation', 'electroconvulsive therapy (ECT', 'video psychoeducation', 'video and brochure psychoeducation']","[""participants' perceptions, knowledge, and willingness to receive ECT""]","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.106646,"Both video and brochure psychoeducation significantly improved participants' perceptions, knowledge, and willingness to receive ECT with only a few significant differences between the two modalities.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'U.S. Department of Veterans Affairs, National Center on Homelessness Among Veterans, Tampa, FL, USA.'}, {'ForeName': 'Minda', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychology, University of Hartford, West Hartford, Connecticut, USA.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Guangzhou Psychiatric Hospital, Guangzhou, China.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': 'U.S. Department of Veterans Affairs, National Center on Homelessness Among Veterans, Tampa, FL, USA.'}]",Asia-Pacific psychiatry : official journal of the Pacific Rim College of Psychiatrists,['10.1111/appy.12395']
2642,32468687,"Nutrition education in Southeast Sulawesi Province, Indonesia: A cluster randomized controlled study.","This study evaluated the impact of a nutrition education intervention on child feeding practices and children's nutritional status. Using a randomized controlled trial, we conducted an intervention for 6 months among caregivers with children aged 6-17 months in two subdistricts of Kendari, SE Sulawesi Province, Indonesia. In all, 22 integrated health posts were randomly assigned to an educational intervention or control group with 266 participants in both groups. Participants in the intervention group attended four nutrition classes and received a monthly home visit by cadres (community volunteers), whereas participants in the control group only received standard monthly health care at the health post. The primary study outcome was children's dietary diversity scores (DDSs). Mixed model analysis was conducted to examine the intervention effects on DDS and children's growth adjusting for clustering within subvillages. The study showed the educational intervention had a significant effect on children's DDS. Children in the intervention group had a larger DDS compared with children in the control group (Beta [mean difference] = 0.34, 95% CI: 0.02 to 0.66, P = 0.038). The intervention effect on height-for-age z-score (HAZ) could not be shown (Beta = 0.24, 95% CI: -0.06 to 0.56, P = 0.112). However, stunting prevalence remained stable in the intervention group but increased in the control group. These results indicated nutrition education delivered through nutrition classes combined with regular home visits by cadres as influencers provided a great potential to be adopted to complement other nutrition programmes in community health centres.",2020,"Children in the intervention group had a larger DDS compared with children in the control group (Beta [mean difference] = 0.34, 95% CI: 0.02 to 0.66, P = 0.038).","['Southeast Sulawesi Province, Indonesia', ""child feeding practices and children's nutritional status"", 'group with 266 participants in both groups', 'caregivers with children aged 6-17 months in two subdistricts of Kendari, SE Sulawesi Province, Indonesia', '22 integrated health posts']","['educational intervention or control', 'nutrition education intervention', 'Nutrition education', 'nutrition classes and received a monthly home visit by cadres (community volunteers), whereas participants in the control group only received standard monthly health care at the health post', 'educational intervention']","['stunting prevalence', 'larger DDS', ""children's DDS"", 'height-for-age z-score (HAZ', ""children's dietary diversity scores (DDSs""]","[{'cui': 'C0376188', 'cui_str': 'Sulawesi'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",266.0,0.0927977,"Children in the intervention group had a larger DDS compared with children in the control group (Beta [mean difference] = 0.34, 95% CI: 0.02 to 0.66, P = 0.038).","[{'ForeName': 'Devi Savitri', 'Initials': 'DS', 'LastName': 'Effendy', 'Affiliation': 'Department of Tropical Nutrition and Food Science, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pattaneeya', 'Initials': 'P', 'LastName': 'Prangthip', 'Affiliation': 'Department of Tropical Nutrition and Food Science, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ngamphol', 'Initials': 'N', 'LastName': 'Soonthornworasiri', 'Affiliation': 'Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pattanee', 'Initials': 'P', 'LastName': 'Winichagoon', 'Affiliation': 'Institute of Nutrition, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Karunee', 'Initials': 'K', 'LastName': 'Kwanbunjan', 'Affiliation': 'Department of Tropical Nutrition and Food Science, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}]",Maternal & child nutrition,['10.1111/mcn.13030']
2643,32468696,"Re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],"['Re: Mesh inlay, mesh kit or native tissue repair']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.19633,,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': ""Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Queensland Institute of Medical Research Berghofer Statistics Unit, Brisbane, QLD, Australia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16301']
2644,32468719,Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design).,"Fingolimod is indicated for the treatment of patients with the relapsing-remitting form of multiple sclerosis. The primary study objective was to evaluate the bioequivalence of a test formulation, 0.5 mg fingolimod HCl capsule (Lebrina, Asofarma Sociedad Anónima Industrial y Comercial, Argentina) relative to a reference formulation, 0.5 mg fingolimod capsule (Gilenya, Novartis Pharmaceutical, Australia). In a single-center, randomized, single-dose, single-blinded, 2-way crossover study, 33 New Zealand healthy subjects of both sexes were enrolled to receive a 0.5-mg dose of 3 capsules of each fingolimod formulation under fasting conditions, with a 42-day washout period between administrations. Additional pharmacokinetic information regarding its main active metabolite, fingolimod phosphate, was also provided. The point estimate and 90% confidence intervals of the ratios of maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours were 99.07 (95.83-102.41) and 97.64 (95.33-100.00) for fingolimod, and 95.60 (90.95-100.49) and 98.54 (96.19-100.96), for fingolimod phosphate. Primary parameters, maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate were found to have no significant difference when test and reference formulations were compared. Fingolimod and fingolimod phosphate of both formulations were within the accepted 90% confidence interval limits of 80.00% and 125.00%. No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated. Notwithstanding the primary conclusion of bioequivalence is focused on the measurement of the parent compound, compliance with the same criteria by the active metabolite reinforces the comparability between the pharmacokinetic profiles of both formulations (ClinicalTrials.gov Identifier: NCT03757338).",2020,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"['patients with the relapsing-remitting form of multiple sclerosis', '33 New Zealand healthy subjects of both sexes', 'New Zealand Healthy Subjects (Truncated Design']","['Fingolimod', '0.5 mg Assessing Both Parent Drug and Active Metabolite', 'fingolimod HCl capsule ']","['maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate', 'ratios of maximum concentration and area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0388087', 'cui_str': 'Fingolimod hydrochloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",33.0,0.0636992,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"[{'ForeName': 'Noelyn Anne', 'Initials': 'NA', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Fernando Guillermo', 'Initials': 'FG', 'LastName': 'Costa', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}, {'ForeName': 'Cheung-Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Mónica Esther', 'Initials': 'ME', 'LastName': 'Rosenberg', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.813']
2645,32468730,"Feasibility, acceptability and affective consequences of at-home sleep extension in young women with depressive symptoms: A pilot study.","Insufficient sleep is common in young adults and has meaningful consequences for daytime functioning, including increased sleepiness, affective disruption and depressive symptoms. This study provides a preliminary evaluation of the feasibility, acceptability and affective consequences of extended sleep opportunity in young women with insufficient sleep and depressive symptoms. Participants were 32 women, 18-22 years of age, who regularly obtained less than 8-hr sleep/night and had daytime sleepiness and depressive symptoms at or above population averages. Participants were asked to maintain a sleep schedule of their typical duration for 7 days and were then randomly assigned to either extend sleep opportunity (ESO) by 90 min per night or maintain typical sleep opportunity (TSO), for the next 7 days. Sleep characteristics and daytime sleepiness were measured using continuous actigraphy and daily sleep diary, and affect, stress and depressive symptoms were assessed with daily and weekly questionnaires. Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO). However, 31.3% of participants (n = 10) were withdrawn from the study due to difficulty maintaining the sleep schedule. These results provide initial evidence that sleep extension is beneficial for young women who usually have inadequate sleep and mood disruption and can maintain a consistent sleep schedule. If extending sleep opportunity improves sleep, daytime sleepiness and affect in young adults who typically have insufficient sleep, it could broaden the range of interventions for sleep and mental wellness.",2020,"Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO).","['Participants were 32 women, 18-22\xa0years of age, who regularly obtained less than 8-hr sleep/night and had daytime sleepiness and depressive symptoms at or above population averages', 'young adults', 'young women with depressive symptoms', 'young adults who typically have insufficient sleep', 'young women with insufficient sleep and depressive symptoms']",['extend sleep opportunity (ESO) by 90\xa0min per night or maintain typical sleep opportunity (TSO'],"['continuous actigraphy and daily sleep diary, and affect, stress and depressive symptoms', 'sleep duration', 'Sleep characteristics and daytime sleepiness', 'sleep, daytime sleepiness', 'Feasibility, acceptability and affective consequences', 'morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",32.0,0.050675,"Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO).","[{'ForeName': 'Melynda D', 'Initials': 'MD', 'LastName': 'Casement', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Livingston', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Forbes', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.'}]",Journal of sleep research,['10.1111/jsr.13045']
2646,32468741,Pharmacokinetics and Safety of Two Voriconazole Formulations After Intravenous Infusion in Healthy Korean Volunteers.,"BACKGROUND


Voriconazole, a triazole antifungal agent exhibits broad-spectrum antifungal activity. It is used to treat severe, invasive fungal infections, including invasive aspergillosis and candidemia. The aim of this study was to assess the pharmacokinetic equivalence of a test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole.
MATERIALS AND METHODS


This was a randomized, open-label, single-dose, three-group, two-treatment, two-sequence, two-period, crossover phase I trial with 7-day washout periods (ClinicalTrials.gov identifier NCT02631954). Twenty-four healthy Korean male subjects were recruited. In each group, eight subjects were randomized in a 1:1 manner to receive a single dose of 200 mg test or reference formulation intravenously over 1.5 h. Blood samples were collected over 24 h post-dose, and plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were determined using a non-compartmental analysis, and safety was evaluated.
RESULTS


Twenty-three subjects completed the study. The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570 (0.8178 - 1.1199) for the maximum plasma concentration (C max ) and 1.0720 (1.0262 - 1.1198) for the area under the concentration-time curve from dosing to the last quantifiable concentration (AUC last ). The mean plasma concentration-time profiles, pharmacokinetic parameters, and safety were comparable between the two formulations.
CONCLUSION


Equivalent pharmacokinetic characteristics that satisfied the criteria of bioequivalence and similar safety profiles were observed for both test and reference formulations of voriconazole.",2020,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"['Twenty-three subjects completed the study', 'Twenty-four healthy Korean male subjects were recruited', 'Healthy Korean Volunteers']","['Two Voriconazole Formulations', 'test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole']","['geometric mean ratio', 'maximum plasma concentration (C max ', 'mean plasma concentration-time profiles, pharmacokinetic parameters, and safety', 'pharmacokinetic equivalence']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1136812', 'cui_str': 'Vfend'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.088423,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"[{'ForeName': 'Sang Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. shcho123@inha.ac.kr.'}, {'ForeName': 'Cheol Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Moon Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}]",Infection & chemotherapy,['10.3947/ic.2020.52.e25']
2647,32468765,Efficacy Of Prophylactic Antibiotics In Reducing Posttonsillectomy Haemorrhage.,"BACKGROUND


This study aims toward establishing the impact of prophylactic pre-operative antimicrobial therapy on tonsillectomy related haemorrhage.
METHODS


In this randomized controlled trial conducted at Combined Military Hospital, Abbottabad from January 2017 till August 2019, 121 children and adult patients who had consented and had undergone tonsillectomy were evaluated for procedure related haemorrhage.
RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics. Patient-reported secondary haemorrhage was recorded in 4.59% (n=9) cases who did not receive pre-operative antibiotic prophylaxis, thereby increasing morbidity and prolonging hospital stay. Secondary post-operative bleeding only occurred in 1.18% (n=2) patients who received appropriate pre-operative anti-microbial prophylaxis.
CONCLUSIONS


We strongly imply that prophylactic pre-operative antibiotics reduce procedure related complications in all patients undergoing tonsillectomy.",2020,"RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics.","['Combined Military Hospital, Abbottabad from January 2017 till August 2019, 121 children and adult patients who had consented and had undergone tonsillectomy were evaluated for procedure related haemorrhage', 'patients undergoing tonsillectomy']","['Prophylactic Antibiotics', 'prophylactic pre-operative antimicrobial therapy']","['Posttonsillectomy Haemorrhage', 'morbidity and prolonging hospital stay', 'secondary haemorrhage', 'Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization', 'operative bleeding']","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0347697', 'cui_str': 'Secondary hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3267156', 'cui_str': 'Operative bleeding'}]",121.0,0.248851,"RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics.","[{'ForeName': 'Nadeem Ahmed', 'Initials': 'NA', 'LastName': 'Sheikh', 'Affiliation': 'Department of Otolaryngology, Combined Military Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Kanwal', 'Initials': 'K', 'LastName': 'Nadeem', 'Affiliation': 'Army Burn Hall College (For Girls), Abbottabad, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
2648,32468855,Comparison between two fast threshold strategies: SPARK and SITA in normal subjects.,"BACKGROUND


Numerous fast threshold strategies have been developed in perimetry which use maximum likelihood approaches to estimate the threshold. A recent approach to threshold estimation has been developed estimating the threshold from a limited number of test points which further reduces examination time. This strategy, SPARK, has not been compared to the SITA strategy. The aim of this study was to compare SPARK with SITA in a normal cohort to evaluate within and between strategy agreement in threshold estimates.
METHODS


A total of 83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye. The eye examined and the order of strategy examined first was randomised but remained constant over the two perimetry visits.
RESULTS


Visual field examination with SPARK Precision was on average 33% faster than SITA Standard. A positive correlation between group mean sensitivities of SITA Standard and SPARK Precision (rho = 0.713, p < 0.001) was found. In total, 95% of stimulus locations were located within the 95% limits of agreement and linear regression on the differences in sensitivities showed no statistically significant proportional bias (t = 1.713, p = 0.09). Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
CONCLUSION


The clinical examination of SPARK yields a sensitivity profile similar to SITA but in a faster examination time. The lower threshold variability of SPARK may be as a result of data smoothing in the threshold estimation process.",2020,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","['normal subjects', '83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye']",[],['mean sensitivities of SITA Standard and SPARK Precision'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",83.0,0.0690914,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","[{'ForeName': 'Foo', 'Initials': 'F', 'LastName': 'Say Kiang', 'Affiliation': 'SEGi University, Faculty of Optometry & Vision Sciences, Petaling Jaya, Malaysia.'}, {'ForeName': 'Cubbidge', 'Initials': 'C', 'LastName': 'Robert Peter', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Heitmar', 'Initials': 'H', 'LastName': 'Rebekka', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}]",European journal of ophthalmology,['10.1177/1120672120926455']
2649,32468883,The use of mind mapping in health education in extended care for children with caries.,"OBJECTIVE


To investigate the application of mind mapping-based health education in extended care for children with caries.
METHODS


This was a prospective study of 159 eligible children with caries. Participants were randomly assigned to an observation group and a control group, and received extended health education and guidance. Patients in the observation group received health education with mind mapping. In the third month after the first visit, a questionnaire survey was conducted to assess knowledge of extended caries diagnosis and treatment in children and their parents. Children also underwent a bacterial plaque test.
RESULTS


Caries knowledge was significantly greater in the observation group than in the control group. There was no significant between-group difference in debris index on the bacterial plaque test. The observation group had a significantly greater number of follow-up visits in 12 months than the control group.
CONCLUSIONS


Mind mapping was effective in the implementation of extended care. Mind mapping information was more accessible to children and their parents, increasing their compliance with health education. Thus, mind mapping is an appropriate health education tool for use in extended care for children with caries.",2020,There was no significant between-group difference in debris index on the bacterial plaque test.,"['159 eligible children with caries', 'children with caries']","['health education with mind mapping', 'mind mapping-based health education', 'control group, and received extended health education and guidance']","['number of follow-up visits', 'Caries knowledge', 'debris index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",159.0,0.0311492,There was no significant between-group difference in debris index on the bacterial plaque test.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Xue-Bin', 'Initials': 'XB', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Ming-He', 'Initials': 'MH', 'LastName': 'Li', 'Affiliation': 'Department of Dentofacial Surgery, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}]",The Journal of international medical research,['10.1177/0300060519898053']
2650,32468892,Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis.,"OBJECTIVE


SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA).
METHODS


Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated.
RESULTS


The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined.
CONCLUSION


In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).",2020,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","['patients with rheumatoid arthritis (RA', 'Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study', '1709 patients', 'rheumatoid arthritis']","['tumour necrosis factor inhibitors', 'ADAbs']","['American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs', 'efficacy and tolerability', 'incidence of ISRs/IRRs', 'likelihood of developing ISRs/IRRs', 'cumulative incidences of ADAbs', 'ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",1709.0,0.148957,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital , Leeds, UK.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Suh', 'Affiliation': 'Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Division of Rheumatology, Mount Sinai Hospital, University of Toronto , Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, Stanford University School of Medicine , Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vencovsky', 'Affiliation': 'Department of Rheumatology, Institute of Rheumatology , Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hong', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghil', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1732458']
2651,30920084,Subjective sleep quality as a mediator in the relationship between pain severity and sustained attention performance in patients with fibromyalgia.,"Pain severity and sleep are associated with cognitive performance in patients with fibromyalgia. This study examined whether sleep mediates the relationships of pain severity with psychomotor vigilance and attention in patients with fibromyalgia by analysing 80 patients with fibromyalgia. Cognitive performance, pain severity and sleep parameters were determined using the Psychomotor Vigilance Task, Brief Pain Inventory-Short Form and sleep diaries of seven consecutive nights, respectively. The patients' demographic data were analysed for potential confounding factors. After adjustment for these confounders, a series of regression analyses was performed to examine the mediating role of sleep. The results indicated that higher pain severity was strongly associated with poorer sustained attention and lower sleep quality, the total effects of pain severity on psychomotor vigilance and attention were significant (c path: β = 0.23, p = 0.04), and pain severity was a significant sleep quality predictor (a path: β = -0.33, p < 0.01). When sleep quality was entered into the regression model (a × b path), the effects of pain severity on psychomotor vigilance and attention became non-significant (c' path: β = 0.15, p = 0.20) after adjustment of age, indicating a complete mediating effect of sleep quality in the pain severity-cognitive performance relationship. In conclusion, sleep quality mediates the pain severity-cognitive performance relationship: pain affects sleep quality, which in turn impairs sustained attention. Our findings provide further insight into the processes underlying the relationship between pain and poor cognitive function. Improved sleep quality may offset the detrimental effects of pain on sustained attention.",2019,"Cognitive performance, pain severity and sleep parameters were determined using the Psychomotor Vigilance Task, Brief Pain Inventory-Short Form and sleep diaries of seven consecutive nights, respectively.","['patients with fibromyalgia by analysing 80 patients with fibromyalgia', 'patients with fibromyalgia']",[],"['Cognitive performance, pain severity and sleep parameters', 'Pain severity and sleep', 'higher pain severity', 'poorer sustained attention and lower sleep quality, the total effects of pain severity on psychomotor vigilance and attention', 'Subjective sleep quality', 'Psychomotor Vigilance Task, Brief Pain Inventory-Short\xa0Form and sleep diaries', 'pain severity', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",80.0,0.0277563,"Cognitive performance, pain severity and sleep parameters were determined using the Psychomotor Vigilance Task, Brief Pain Inventory-Short Form and sleep diaries of seven consecutive nights, respectively.","[{'ForeName': 'Su-Chen', 'Initials': 'SC', 'LastName': 'Fang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hao-Wen', 'Initials': 'HW', 'LastName': 'Teng', 'Affiliation': 'Department of Neurology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}]",Journal of sleep research,['10.1111/jsr.12843']
2652,31424575,Health Literacy Matters More Than Experience for Advance Care Planning Knowledge Among Older Adults.,"BACKGROUND


Advance care planning (ACP) engagement is low among vulnerable populations, including those with limited health literacy (LHL). Limited knowledge about ACP may be a modifiable mediator of the relationship between LHL and ACP. Our goal was to determine whether health literacy is associated with ACP knowledge.
DESIGN


Cross-sectional design.
SETTING


A public health delivery system and Veterans Affairs Medical Center in San Francisco, CA.
PARTICIPANTS


English- and Spanish-speaking patients (N = 1400).
MEASUREMENTS


ACP knowledge was assessed with seven validated multiple-choice questions. Health literacy was measured using a validated scale. Sociodemographic measures included age, sex, language, education, race, health status, and social support. Prior ACP experience was defined as having documented legal forms and/or goals-of-care discussions in the medical record. We used Kruskal-Wallis tests and linear regression to examine associations of ACP knowledge with LHL, prior ACP experience, and sociodemographic factors.
RESULTS


Mean age of participants was 65 (±10) years, 48% were women, 34% had LHL, 32% were Spanish speaking, 47% had high school education or less, and 70% were nonwhite. Mean 7-point knowledge scores were lower for those with limited vs adequate health literacy (3.8 [SD = 1.9 vs 5.5 (SD = 1.7); P < .001). In multivariable analysis, ACP knowledge scores were 1.0 point lower among those with LHL; 0.6 points lower among Spanish speakers and those with high school education or less; and 0.5 points lower among individuals of nonwhite race (P < .001 for all). Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005). Prior ACP experience was not associated with knowledge after adjustment (P = .7).
CONCLUSIONS


Health literacy and sociodemographics are stronger predictors than prior ACP experience of ACP knowledge. This study suggests that providing easy-to-understand ACP materials is paramount and should be offered even if patients have previous experience with the ACP process. J Am Geriatr Soc 67:2151-2156, 2019.",2019,Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005).,"['English- and Spanish-speaking patients (N = 1400', 'Older Adults', 'Health Literacy Matters', 'patients have previous experience with the ACP process', 'A public health delivery system and Veterans Affairs Medical Center in San Francisco, CA', 'Mean age of participants was 65 (±10) years, 48% were women, 34% had LHL, 32% were Spanish speaking, 47% had high school education or less, and 70% were nonwhite']",[],"['ACP knowledge', 'ACP knowledge scores', 'Mean 7-point knowledge scores', 'Knowledge scores', 'Health literacy', 'age, sex, language, education, race, health status, and social support']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}]",[],"[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0224261,Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005).,"[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Nouri', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'McMahan', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Kushel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Chengshi', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16129']
2653,31431378,Cost-effectiveness analysis of neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced esophageal squamous cell carcinoma based on the NEOCRTEC5010 trial.,"BACKGROUND AND PURPOSE


The phase 3 NEOCRTEC5010 trial demonstrated that neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) had significantly greater efficacy than surgery alone did, but at the same time, the addition of NCRT places an economic burden on patients. This study assessed the cost-effectiveness of NCRT followed by surgery based on the NEOCRTEC5010 trial.
MATERIALS AND METHODS


A three-state Markov model (disease-free survival, relapse and death) based on data from the NEOCRTEC5010 trial was used to estimate the incremental cost-effectiveness ratio (ICER) of NCRT plus surgery versus surgery alone for ESCC. The model evaluates the outcomes from the perspective of Chinese society. Costs, quality-adjusted life-years (QALYs), and the ICER in terms of 2019 US$ per QALY gained, were calculated. Model robustness was evaluated with one-way and probabilistic sensitivity analyses.
RESULTS


Compared with surgery alone, NCRT plus surgery increased costs by $14933.57, while gaining 3.08 QALYs, resulting in an ICER of $4848.56 per QALY. The ICER was far below the commonly accepted willingness-to-pay threshold ($26,157 per QALY). The duration of disease-free survival (DFS) for the group that received NCRT was the crucial factor in determining the ICER.
CONCLUSION


Compared with surgery alone, NCRT followed by surgery for locally advanced ESCC can be cost-effective because of significant clinical benefits.",2019,"Compared with surgery alone, NCRT plus surgery increased costs by $14933.57, while gaining 3.08 QALYs, resulting in an ICER of $4848.56 per QALY.","['locally advanced esophageal squamous cell carcinoma', 'locally advanced esophageal squamous cell carcinoma (ESCC']","['NCRT', 'neoadjuvant chemoradiotherapy (NCRT) plus surgery', 'neoadjuvant chemoradiotherapy followed by surgery versus surgery alone', 'NCRT plus surgery versus surgery alone for ESCC']","['costs', 'Costs, quality-adjusted life-years (QALYs), and the ICER', 'duration of disease-free survival (DFS', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.0718907,"Compared with surgery alone, NCRT plus surgery increased costs by $14933.57, while gaining 3.08 QALYs, resulting in an ICER of $4848.56 per QALY.","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhan', 'Affiliation': 'Department of Pharmacy, West China Hospital, Sichuan University, China; West China Biomedical Big Data Center, Sichuan University, China.'}, {'ForeName': 'Hanrui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, West China Hospital, Sichuan University, China; West China Biomedical Big Data Center, Sichuan University, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'West China Biomedical Big Data Center, Sichuan University, China; Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, West China Hospital, Sichuan University, China. Electronic address: tingx2009@163.com.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'West China Biomedical Big Data Center, Sichuan University, China; Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, China. Electronic address: fbqiu9@163.com.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.07.031']
2654,31562105,Soft Wearable Skin-Stretch Device for Haptic Feedback Using Twisted and Coiled Polymer Actuators.,"Soft and integrated design can enable wearable haptic devices to augment natural human taction. This paper proposes a novel, soft, haptic finger-worn wearable device based on compliant and adhesive silicone skin and lightweight twisted and coiled polymer (TCP) actuators using ultra high molecular weight polyethylene (UHMWPE) fibers to provide lateral skin stretch sensations. Recently, silicone elastomers have been used in wearable sensors and in haptic applications for their high compliance or adhesion. TCP actuators have also demonstrated high power to weight ratios, large stroke length, simple mechanism, and inherent softness. Lateral skin stretch is sensitive to small motions and has been used for intuitive proprioceptive feedback applications. We combined these characteristics to design and manufacture a wearable, functional haptic prototype. Prototype performance was evaluated using an optical tracking system, a force gauge test bench, and compared to vibrotactile haptic feedback in a experiment with 14 healthy participants. Results showed that participant mean reaction times were comparable to those of a vibrotactile feedback system, though task completion times were longer. This paper is the first to employ TCP actuators for haptic stimulation and could serve as a foundation for future applications involving soft wearable haptics in gaming, health, and virtual reality.",2019,"Results showed that participant mean reaction times were comparable to those of a vibrotactile feedback system, though task completion times were longer.",['14 healthy participants'],"['vibrotactile haptic feedback', 'Soft Wearable Skin-Stretch Device for Haptic Feedback Using Twisted and Coiled Polymer Actuators']",['participant mean reaction times'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0558242', 'cui_str': 'Stretched skin'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1706706', 'cui_str': 'Actuator'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",14.0,0.0129741,"Results showed that participant mean reaction times were comparable to those of a vibrotactile feedback system, though task completion times were longer.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Chossat', 'Affiliation': ''}, {'ForeName': 'Daniel K Y', 'Initials': 'DKY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yong-Lae', 'Initials': 'YL', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Shull', 'Affiliation': ''}]",IEEE transactions on haptics,['10.1109/TOH.2019.2943154']
2655,32276577,Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies.,"AIMS


Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors consistently reduce low-density lipoprotein cholesterol (LDL-C) by 50-60% and lipoprotein(a) (Lp(a)) by 20-30%, but the mechanism of Lp(a) lowering remains unclear. If Lp(a) is cleared by the LDL receptor, similar to LDL-C, then one would expect PCSK9 inhibition to induce a concordant LDL-C/Lp(a) response in an approximately 2:1 ratio. We aim to determine the prevalence of discordant plasma LDL-C/Lp(a) response to the PCSK9 inhibitor alirocumab.
METHODS


This is a post hoc, pooled analysis of 10 randomized controlled trials from the ODYSSEY Phase 3 clinical trial program for alirocumab. Patients enrolled in the trials were high cardiovascular risk and/or with heterozygous familial hypercholesterolemia. The primary end point was prevalence of discordant LDL-C/Lp(a) response to alirocumab at 24 weeks. Discordant response was defined as LDL-C reduction >35% and Lp(a) reduction ≤10%, or LDL-C reduction ≤35% and Lp(a) reduction >10%.
RESULTS


Of the 1709 patients in the pooled study cohort, 62.4% were male, and the mean age was 59.2 (SD: 11.0) years. Baseline mean LDL-C was 126.5 (SD: 46.3) mg/dL and baseline median Lp(a) was 46.9 (interquartile range: 21.8-89.0) mg/dL. Total prevalence of discordant LDL-C/Lp(a) response was 21.5% (12.6% with LDL-C >35% reduction and Lp(a) ≤10% reduction; 8.9% with LDL-C ≤35% reduction and Lp(a) >10% reduction). Baseline Lp(a) and familial hypercholesterolemia status did not affect discordance.
CONCLUSION


A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.",2020,"A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.","['Patients enrolled in the trials were high cardiovascular risk and/or with heterozygous familial hypercholesterolemia', '1709 patients in the pooled study cohort, 62.4% were male, and the mean age was 59.2']","['alirocumab', 'Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors']","['Total prevalence of discordant LDL-C/Lp(a) response', 'prevalence of discordant LDL-C/Lp(a) response', 'Baseline Lp(a) and familial hypercholesterolemia status', 'Lp(a', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1709.0,0.0845055,"A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.","[{'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Mahmood', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Minnier', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Ito', 'Affiliation': 'Sanofi, USA.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals Inc., USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi, USA.'}, {'ForeName': 'Ivy W', 'Initials': 'IW', 'LastName': 'Kam', 'Affiliation': 'Regeneron Pharmaceuticals Inc., USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fazio', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Shapiro', 'Affiliation': 'Center for Preventive Cardiology, Wake Forest University Baptist Medical Center, Section on Cardiovascular Medicine, USA.'}]",European journal of preventive cardiology,['10.1177/2047487320915803']
2656,32459070,Distinct peripheral blood molecular signature emerges with successful tacrolimus withdrawal in kidney transplant recipients.,"Tacrolimus (Tac) is an effective anti-rejection agent in kidney transplantation, but its off-target effects make withdrawal desirable. Although studies indicate that Tac can be safely withdrawn in a subset of kidney transplant recipients, immune mechanisms that underlie successful vs unsuccessful Tac removal are unknown. We performed microarray analyses of peripheral blood mononuclear cells (PBMC) RNA from subjects enrolled in the Clinical Trials in Organ Transplantation-09 study in which we randomized stable kidney transplant recipients to Tac withdrawal or maintenance of standard immunosuppression beginning 6 months after transplant. Eight of 14 subjects attempted but failed withdrawal, while six developed stable graft function for ≥2 years on mycophenolate mofetil plus prednisone. Whereas failed withdrawal upregulated immune activation genes, successful Tac withdrawal was associated with a downregulatory and proapoptotic gene program enriched within T cells. Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction. Together, our data from a small, but unique, patient cohort support the conclusion that successful Tac withdrawal is not simply due to absence of donor-reactive immunity but rather is associated with an active immunological process.",2020,Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction.,"['subjects who failed withdrawal without evidence of regulatory T cell dysfunction', 'subjects enrolled in the Clinical Trials in Organ Transplantation-09 study in which we randomized stable kidney transplant recipients to Tac withdrawal or maintenance of standard immunosuppression beginning 6 months after transplant', 'kidney transplant recipients']","['Tacrolimus (Tac', 'mycophenolate mofetil plus prednisone']",['stable graft function'],"[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",14.0,0.0229915,Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cravedi', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fribourg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Zhengzi', 'Initials': 'Z', 'LastName': 'Yi', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zaslavsky', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Nudelman', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hartzell', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Brouard', 'Affiliation': 'Centre de Recherche en Transplantation et Immunologie, Université de Nantes, CHU Nantes, Inserm, Nantes, France.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Heeger', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15979']
2657,32459117,Effects of rosuvastatin and zoledronic acid in combination on the recovery of senile osteoporotic vertebral compression fracture following percutaneous vertebroplasty.,"OBJECTIVES


This study analyzed the effects of rosuvastatin and zoledronic acid in combination on patient recovery following percutaneous vertebroplasty (PVP) that was performed to treat senile osteoporotic vertebral compression.
METHODS


Senile patients with osteoporotic vertebral compression fracture (n = 120) were included in this retrospective study, and they were classified into two groups. Those in the control group (n = 60) were treated with PVP + caltrate and those in the observation group (n = 60) received this treatment with combined zoledronic acid and rosuvastatin. Between-group comparisons were made at both pre- and post-treatment regarding bone density, type I procollagen peptide (CTX) and bone-specific alkaline phosphatase (BAP) levels, visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, and adjacent centrum refracture.
RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group. The refracture rate in the observation group was lower compared with the control group.
CONCLUSION


Treatment with a combination of rosuvastatin and zoledronic acid following PVP can improve the condition of senile osteoporotic vertebral compression fracture and patient's functional status, and it can also alleviate pain.",2020,"RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group.","['Senile patients with osteoporotic vertebral compression fracture (n\u2009=\u2009120', 'senile osteoporotic vertebral compression fracture following percutaneous vertebroplasty']","['percutaneous vertebroplasty (PVP', 'combined zoledronic acid and rosuvastatin', 'rosuvastatin and zoledronic acid following PVP', 'rosuvastatin and zoledronic acid', 'PVP\u2009+\u2009caltrate']","['BAP and CTX levels', 'bone density, type I procollagen peptide (CTX) and bone-specific alkaline phosphatase (BAP) levels, visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, and adjacent centrum refracture', 'refracture rate', 'ODI and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0719118', 'cui_str': 'Caltrate'}]","[{'cui': 'C0047830', 'cui_str': ""4,4'-thiodianiline""}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0210401,"RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Shunlun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520925390']
2658,32459129,Consolidation of Reward Memory during Sleep Does Not Require Dopaminergic Activation.,"Sleep enhances memories, especially if they are related to future rewards. Although dopamine has been shown to be a key determinant during reward learning, the role of dopaminergic neurotransmission for amplifying reward-related memories during sleep remains unclear. In this study, we scrutinize the idea that dopamine is needed for the preferential consolidation of rewarded information. We impaired dopaminergic neurotransmission, thereby aiming to wipe out preferential sleep-dependent consolidation of high- over low-rewarded memories during sleep. Following a double-blind, balanced, crossover design, 17 young healthy men received the dopamine d2-like receptor blocker sulpiride (800 mg) or placebo, after learning a motivated learning task. The task required participants to memorize 80 highly and 80 lowly rewarded pictures. Half of them were presented for a short (750 msec) and a long (1500 msec) duration, respectively, which permitted dissociation of the effects of reward on sleep-associated consolidation from those of mere encoding depth. Retrieval was tested after a retention interval of approximately 22 hr that included 8 hr of nocturnal sleep. As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo. However, there was no evidence for an effect of reducing dopaminergic neurotransmission with sulpiride during sleep on this differential retention of rewarded information. This result indicates that dopaminergic activation likely is not required for the preferential consolidation of reward-associated memory. Rather, it appears that dopaminergic activation only tags such memories at encoding for intensified reprocessing during sleep.",2020,"As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo.",['17 young healthy men'],"['dopamine d2-like receptor blocker sulpiride (800 mg) or placebo', 'dopamine', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],17.0,0.110276,"As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo.","[{'ForeName': 'Marjan Alizadeh', 'Initials': 'MA', 'LastName': 'Asfestani', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Brechtmann', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Santiago', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Peter', 'Affiliation': 'German Center for Diabetes Research (DZD), Tübingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Born', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Gordon Benedikt', 'Initials': 'GB', 'LastName': 'Feld', 'Affiliation': 'University of Tübingen.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01585']
2659,32459220,[Fracture strength of various types of direct and indirect restorations in the functional repair of endodontically treated molars].,"The fracture strength of endodontically treated molars restored by means of various types of direct and indirect materials was studied in vitro. 105 sound molars were endodontically treated and randomly assigned to 1 control group (endodontic access cavity only) and 6 experimental groups (n = 15) with restorations of the following materials: glass fibre reinforced composite (GFRC); microhybrid composite (C); microhybrid composite restoration with glass fiber post (CP); full-contour lithium disilicate crown (LDS); full-contour lithium disilicate crown with glass fiber post (P-LDS); and an endocrown (EC). Specimens were thermo-mechanically aged and axially loaded until failure. Data were analysed using ANOVA and Tukey's post hoc test (α = 0.05). Fracture strength was significantly affected by the type of restoration (p = 0.000). LDS had significantly higher fracture strength than the control group and GFRC, C and CP groups. Groups EC, LDS and P-LDS were not statistically different from each other in fracture strength. This was also the case with EC, P-LDS and all composite groups. The glass fibre strength of composite restoration resulted in significantly fewer fatal fractures.",2020,"Groups EC, LDS and P-LDS were not statistically different from each other in fracture strength.","['Specimens were thermo-mechanically aged and axially loaded until failure', '105 sound molars']","['direct and indirect restorations', 'LDS', 'control group (endodontic access cavity only) and 6 experimental groups (n = 15) with restorations of the following materials: glass fibre reinforced composite (GFRC); microhybrid composite (C); microhybrid composite restoration with glass fiber post (CP); full-contour lithium disilicate crown (LDS); full-contour lithium disilicate crown with glass fiber post (P-LDS); and an endocrown (EC']","['fracture strength', 'Fracture strength', 'fatal fractures']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",105.0,0.0201424,"Groups EC, LDS and P-LDS were not statistically different from each other in fracture strength.","[{'ForeName': 'M C F M', 'Initials': 'MCFM', 'LastName': 'de Kuijper', 'Affiliation': ''}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Gresnigt', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van den Houten', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haumahu', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schepke', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cune', 'Affiliation': ''}]",Nederlands tijdschrift voor tandheelkunde,['10.5177/ntvt.2020.04.19093']
2660,32459281,Determinants of the serial changes in measurements of renal allograft Doppler resistive index in the first postoperative month.,"INTRODUCTION


The role of single Doppler-derived renal resistive index (RI) in renal allograft management is still a controversial issue, however detection of changes in serial duplex scanning has been reported as more valuable. This study aimed to test the hypothesis that early change in RI following transplantation may be related to factors associated with delayed graft function (DGF).
MATERIAL AND METHODS


113 patients were included, in whom two RI measurements were performed within 30 days post-transplant. According to an RI change (equal to or more than 10%) in the second measurement, patients were assigned to decrease (Group I), no change (Group II), or increase (Group III) group.
RESULTS


30 subjects had a decrease, 55 had no change, and 28 had an increase in the second RI measurement. The donors were younger in Group III in comparison to Group II. In comparison to Group I, Group III had a higher frequency of deceased donor, DGF, and presence of tubular necrosis and tubular vacuolization in peri-implantation biopsies.
CONCLUSION


the increase of RI during the first weeks of the postoperative period seems to be associated with DGF and with tubular necrosis / tubular vacuolization in peri-implantation biopsies, likely related to ischemia reperfusion injury.",2020,The donors were younger in Group III in comparison to Group II.,['113 patients'],['single Doppler-derived renal resistive index (RI'],"['frequency of deceased donor, DGF, and presence of tubular necrosis and tubular vacuolization', 'second RI measurement', 'renal allograft Doppler resistive index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1720775', 'cui_str': 'Renal tubular necrosis'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0010840', 'cui_str': 'Vacuolation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}]",113.0,0.0137971,The donors were younger in Group III in comparison to Group II.,"[{'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Moura-Neto', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Divisão de Nefrologia, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Ana Flávia', 'Initials': 'AF', 'LastName': 'Moura', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Divisão de Nefrologia, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'José Hermógenes Rocco', 'Initials': 'JHR', 'LastName': 'Suassuna', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Divisão de Nefrologia, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Nordeval Cavalcante', 'Initials': 'NC', 'LastName': 'Araújo', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Divisão de Nefrologia, Rio de Janeiro, RJ, Brasil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-JBN-2018-0232']
2661,32459282,"Resistant starch supplementation effects on plasma indole 3-acetic acid and aryl hydrocarbon receptor mRNA expression in hemodialysis patients: Randomized, double blind and controlled clinical trial.","INTRODUCTION


Gut microbiota imbalance is linked to high uremic toxins production such as indole-3-acetic acid (IAA) in chronic kidney disease patients. This toxin can activate the aryl hydrocarbon receptor (AhR), a ligand-activated transcription factor involved with inflammation. Strategies to restore gut microbiota balance can be associated with reduced production of IAA and its deleterious effects. This study aimed to evaluate prebiotic resistant starch (RS) supplementation effects on IAA plasma levels and AhR mRNA expression in CKD patients on hemodialysis (HD).
METHODS


This randomized, double-blind and placebo-controlled clinical trial evaluated forty-two stable HD patients allocated in RS (n=22) or placebo (n=20) groups. Patients received, alternately, cookies and sachets containing 16 g/day of RS (Hi-Maize 260®) or manioc flour for four weeks. Fasting pre-dialysis blood samples were collected and IAA plasma levels measured by high performance liquid chromatography. Peripheral blood mononuclear cells were isolated and processed for AhR and nuclear factor kappa B (NF-κB) mRNA expression analyzes by quantitative real-time PCR. Anthropometric and biochemical parameters, as well as food intake were also evaluated.
RESULTS


Thirty-one patients completed the study, 15 in the RS group and 16 in the placebo group. Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
CONCLUSION


Even though prebiotic RS supplementation did not influence IAA levels or AhR expression, their positive association reinforces a possible interaction between them.",2020,"Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
","['CKD patients on hemodialysis (HD', 'forty-two stable HD patients allocated in RS (n=22) or', 'chronic kidney disease patients', 'n=20) groups', 'hemodialysis patients']","['placebo', 'prebiotic RS supplementation', 'Resistant starch supplementation', 'prebiotic resistant starch (RS) supplementation']","['Peripheral blood mononuclear cells', 'IAA plasma levels', 'IAA plasma levels and AhR expression', 'AhR mRNA expression and NF-κB mRNA expression', 'IAA plasma levels and AhR mRNA expression']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052441', 'cui_str': 'Aryl Hydrocarbon Receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",42.0,0.14231,"Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Azevedo', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Esgalhado', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Kemp', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Regis', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Ludmila Fmf', 'Initials': 'LF', 'LastName': 'Cardozo', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Lia S', 'Initials': 'LS', 'LastName': 'Nakao', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-graduação em Ciências Médicas, Curitiba, PR, Brazil.'}, {'ForeName': 'Jessyca Sousa de', 'Initials': 'JS', 'LastName': 'Brito', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mafra', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-JBN-2020-0003']
2662,32459322,Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial.,"Importance


Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.
Objective


To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA.
Design, Setting, and Participants


In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol.
Interventions


Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA.
Main Outcomes and Measures


The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution.
Results


Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%).
Conclusions and Relevance


This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings.
Trial Registration


German Clinical Trials Register: DRKS00007784.",2020,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","['June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy', '248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years', 'pain control after pancreatic surgery', 'n\u2009=\u2009186); 248 patients (124 in each group) were analyzed']","['Pancreatoduodenectomy', 'Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA', 'EDA', 'Epidural vs Patient-Controlled Intravenous Analgesia', 'PCIA and EDA', 'general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device', 'PCIA']","['gastrointestinal complications', '30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids', '30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution', 'composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus', 'Gastrointestinal Complications', 'Failure of EDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]",,0.168465,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Klotz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klose', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Tenckhoff', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lock', 'Affiliation': 'Department of General, Visceral, Transplant, Vascular and Paediatric Surgery, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Elmar-Marc', 'Initials': 'EM', 'LastName': 'Brede', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Surgical and Oncological Department, Pancreas Institute, University Hospital Trust, Verona, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Polati', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Verona University Hospital, Verona, Italy.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Köninger', 'Affiliation': 'Department of General, Visceral, Thorax and Transplantation Surgery, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Jan-Henrik', 'Initials': 'JH', 'LastName': 'Schiff', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Uwe A', 'Initials': 'UA', 'LastName': 'Wittel', 'Affiliation': 'Department of General and Visceral Surgery, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hötzel', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Keck', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anca-Laura', 'Initials': 'AL', 'LastName': 'Amati', 'Affiliation': 'Department of Visceral, Thoracic, Transplant and Paediatric Surgery, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eberl', 'Affiliation': 'Department of Surgery, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zink', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Tomazic', 'Affiliation': 'Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Novak-Jankovic', 'Affiliation': 'Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hofer', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.0794']
2663,32459348,Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.,"Importance


Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden.
Objective


To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain.
Design, Setting, and Participants


Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019.
Interventions


The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual.
Main Outcomes and Measures


Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments.
Results


A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44).
Conclusions and Relevance


Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible.
Trial Registration


German Clinical Trials Register Identifier: DRKS00007960.",2020,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","['Patients With Persistent Back Pain', 'patients with persistent back pain', '295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4', 'Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017', 'Back Pain Patients (PROD-BP']","['web-based self-help intervention', 'e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy', 'Guided Web-Based Self-help Intervention']","['time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5', 'incidence of major depressive episode (MDE', 'MDE', 'risk of MDE onset', 'depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",295.0,0.196853,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","[{'ForeName': 'Lasse B', 'Initials': 'LB', 'LastName': 'Sander', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Paganini', 'Affiliation': 'Institute for Sports and Sport Science, Department of Sports Psychology, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Institute of Psychology and Education, Department of Research Methods, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Medical Center, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Spanhel', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Institute of Psychology and Education, Department of Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1021']
2664,32453851,Short-term Perceptual Learning Game Does Not Improve Patching-Resistant Amblyopia in Older Children.,"PURPOSE


To investigate self-administered, at-home use of a perceptual learning-based video game consisting of target detection of stimuli in different sizes, spatial frequency, orientation, and contrast as a potential dichoptic therapy to improve binocular function in amblyopic patients resistant to patching.
METHODS


Children (ages 8 to 18 years) with strabismic and/or anisometropic amblyopia were recruited from a single institution. All participants (n = 25) were prescribed 6 weeks of patching for 2 hours per day, and those whose visual acuity did not improve were randomized to binocular perceptual learning (n = 7), monocular perceptual learning (n = 8), or patching (n = 10) groups for 8 weeks in this prospective cohort study. After an 8-week long period of treatment cessation, during which participants stopped patching or perceptual learning, participants in the patching group were randomized to binocular or monocular perceptual learning training; those in the perceptual learning groups remained the same. Visual function was assessed by visual acuity, low contrast acuity, reading speed, stereoacuity, and binocularity; compliance was evaluated by exercise logs.
RESULTS


There were no significant improvements in visual function parameters, which did not vary by treatment group. However, some visual outcomes, such as binocular summation and reading speed, correlated positively with compliance to perceptual learning therapy.
CONCLUSIONS


At-home, self-administered use of this perceptual learning-based video game-based visual training does not consistently add therapeutic benefit to those with amblyopia resistant to patching. Future investigation is required to determine whether methods to increase compliance will lead to more reliable outcomes. [J Pediatr Ophthalmol Strabismus. 2020;57(3):176-184.].",2020,"There were no significant improvements in visual function parameters, which did not vary by treatment group.","['Children (ages 8 to 18 years) with strabismic and/or anisometropic amblyopia were recruited from a single institution', 'Older Children', 'All participants (n = 25', 'amblyopic patients resistant to patching']","['perceptual learning-based video game', 'perceptual learning-based video game-based visual training', 'Short-term Perceptual Learning Game', 'monocular perceptual learning (n = 8), or patching', 'binocular perceptual learning', 'binocular or monocular perceptual learning training']","['binocular function', 'binocular summation and reading speed', 'visual acuity, low contrast acuity, reading speed, stereoacuity, and binocularity; compliance', 'visual function parameters', 'Visual function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234108', 'cui_str': 'Summation'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",25.0,0.0364774,"There were no significant improvements in visual function parameters, which did not vary by treatment group.","[{'ForeName': 'Yoon H', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maniglia', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Velez', 'Affiliation': ''}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Demer', 'Affiliation': ''}, {'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Seitz', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Pineles', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20200306-01']
2665,32453876,"Metabolomics Reveals Altered Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids Associated with Marginal Vitamin A Deficiency in a Mongolian Gerbil Model.","SCOPE


This study was designed to provide a broad evaluation of the impacts of vitamin A (VA) deficiency on hepatic metabolism in a gerbil model.
METHODS AND RESULTS


After 28d of VA depletion, male Mongolian gerbils (Meriones unguiculatus) were randomly assigned to experimental diets for 28 d. Groups were fed a white maize-based diet with ∼50 μL cottonseed oil vehicle either alone (VA-, n = 10) or containing 40 μg retinyl acetate (VA+, n = 10) for 28 d. Liver retinol was measured by high-performance liquid chromatography (HPLC). Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides and endocannabinoids were determined in post-mortem liver samples by liquid chromatography-mass spectrometry (LC-MS).
RESULTS


Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency. A total of 300 metabolites were identified. Marginal VA deficiency was associated with lower bile acids, trimethylamine N-oxide, and a variety of acyl carnitines, phospholipids and sphingomyelins (p < 0.05). Components of DNA, including purine deoxyribonucleosides, deoxyguanosine, the nucleoside cytidine, and the uracil derivative N-carbomoyl-beta-alanine (p < 0.05), were differentially altered.
CONCLUSIONS


Hepatic metabolomics in a marginally VA deficient gerbil model revealed alterations in markers of the gut microbiome, fatty acid and nucleotide metabolism, and cellular structure and signaling. This article is protected by copyright. All rights reserved.",2020,"RESULTS


Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.",['male Mongolian gerbils (Meriones unguiculatus'],"['white maize-based diet with ∼50\xa0μL cottonseed oil vehicle either alone (VA-, n\xa0=\xa010) or containing 40\xa0μg retinyl acetate (VA+, n\xa0=\xa010) for 28 d. Liver retinol was measured by high-performance liquid chromatography (HPLC', 'vitamin A (VA) deficiency']","['Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides and endocannabinoids', 'Liver retinol', 'Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0324939', 'cui_str': 'Meriones unguiculatus'}, {'cui': 'C0022392', 'cui_str': 'Meriones'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073109', 'cui_str': 'Retinol acetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025249', 'cui_str': 'Membrane lipid'}]",300.0,0.057129,"RESULTS


Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'La Frano', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Laboratory of Pharmacokinetics and Metabolomic Analysis, Institute of Translational Medicine and Biotechnology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Baylee', 'Initials': 'B', 'LastName': 'Wilhelmson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Rob K', 'Initials': 'RK', 'LastName': 'Fanter', 'Affiliation': 'College of Agriculture, Food and Environmental Sciences, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Pedersen', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901319']
2666,32453913,"Febuxostat, But Not Allopurinol, Markedly Raises the Plasma Concentrations of the Breast Cancer Resistance Protein Substrate Rosuvastatin.","Xanthine oxidase inhibitors febuxostat and allopurinol are commonly used in the treatment of gout. Febuxostat inhibits the breast cancer resistance protein (BCRP) in vitro. Rosuvastatin is a BCRP substrate and genetic variability in BCRP markedly affects rosuvastatin pharmacokinetics. In this study, we investigated possible effects of febuxostat and allopurinol on rosuvastatin pharmacokinetics. In a randomized crossover study with 3 phases, 10 healthy volunteers ingested once daily placebo for 7 days, 300 mg allopurinol for 7 days, or placebo for 3 days, followed by 120 mg febuxostat for 4 days, and a single 10 mg dose of rosuvastatin on day 6. Febuxostat increased the peak plasma concentration and area under the plasma concentration-time curve of rosuvastatin 2.1-fold (90% confidence interval 1.8-2.6; P = 5 × 10 -5  ) and 1.9-fold (1.5-2.5; P = 0.001), but had no effect on rosuvastatin half-life or renal clearance. Allopurinol, on the other hand, did not affect rosuvastatin pharmacokinetics. In vitro, febuxostat inhibited the ATP-dependent uptake of rosuvastatin into BCRP-overexpressing membrane vesicles with a half-maximal inhibitory concentration of 0.35 µM, whereas allopurinol showed no inhibition with concentrations up to 200 µM. Taken together, the results suggest that febuxostat increases rosuvastatin exposure by inhibiting its BCRP-mediated efflux in the small intestine. Febuxostat may, therefore, serve as a useful index inhibitor of BCRP in drug-drug interaction studies in humans. Moreover, concomitant use of febuxostat may increase the exposure to BCRP substrate drugs and, thus, the risk of dose-dependent adverse effects.",2020,"In vitro, febuxostat inhibited the ATP-dependent uptake of rosuvastatin into BCRP-overexpressing membrane vesicles with a half-maximal inhibitory concentration of 0.35 µM, whereas allopurinol showed no inhibition with concentrations up to 200 µM. Taken together, the results suggest that febuxostat increases rosuvastatin exposure by inhibiting its BCRP-mediated efflux in the small intestine.",['10 healthy volunteers'],"['rosuvastatin', 'ingested once daily placebo', 'placebo', 'Xanthine oxidase inhibitors febuxostat and allopurinol', 'Rosuvastatin', 'Febuxostat', 'allopurinol', 'febuxostat', 'febuxostat and allopurinol', 'Allopurinol']","['peak plasma concentration and area under the plasma concentration-time curve of rosuvastatin', 'rosuvastatin half-life or renal clearance', 'rosuvastatin pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",10.0,0.0530256,"In vitro, febuxostat inhibited the ATP-dependent uptake of rosuvastatin into BCRP-overexpressing membrane vesicles with a half-maximal inhibitory concentration of 0.35 µM, whereas allopurinol showed no inhibition with concentrations up to 200 µM. Taken together, the results suggest that febuxostat increases rosuvastatin exposure by inhibiting its BCRP-mediated efflux in the small intestine.","[{'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Lehtisalo', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jenni E', 'Initials': 'JE', 'LastName': 'Keskitalo', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Tornio', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Lapatto-Reiniluoto', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Jaatinen', 'Affiliation': 'The Finnish Red Cross Blood Service, Helsinki, Finland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Viinamäki', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Neuvonen', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Janne T', 'Initials': 'JT', 'LastName': 'Backman', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Niemi', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Clinical and translational science,['10.1111/cts.12809']
2667,32453996,Effects of Constraint-Induced Movement Therapy on upper limb activity according to a bi-dimensional kinematic analysis in progressive multiple sclerosis patients: a randomized single-blind pilot study.,"Multiple sclerosis (MS) is a chronic disease of the central nervous system, characterized by demyelinization and axonal loss resulting, in 66% of cases, in upper limb motor impairment. The effects of constraint-induced movement therapy (CIMT) have recently been investigated in MS patients. The aim of this randomized single-blind pilot study was to assess the effects of CIMT on upper limb activity, specifically smoothness of movement, in patients affected by progressive MS. Patients affected by MS, and reporting reduced use primarily of one upper limb, were enrolled and randomly allocated to two different groups: a CIMT group, where treatment was performed with the less affected limb immobilized by a splint, and a control group, submitted to intensive bi-manual treatment. All evaluations were performed at baseline (T0) and after two weeks of treatment (T1) by an operator unaware of the patients' allocation. The primary outcome was the difference in movement smoothness, measured by means of a bidimensional kinematic evaluation. Secondary outcomes were: endpoint error and arm trajectory mean speed. Furthermore, patients performed the Hand Grip Strength Test (HGS) and 9-Hole Peg Test (9HPT), for both arms, at both time points. Ten patients with MS (4 males, 6 females; mean age 51.0±7.7 years) were randomly allocated to the CIMT group (n=5) and control group (n=5). There were no significant differences between groups in any of the data assessed at baseline. In the CIMT group subjects, the treatment effect, in terms of movement smoothness, was significant at the more affected limb (p=0.0376). The CIMT group displayed statistically significant improvements, versus the baseline values, in muscle strength (HGS:22.4±8.3 vs 26.0±6.0; p<0.05) and dexterity (9HPT: 31.8±6.1 vs 27.4±4.9; p<0.05) of the more affected limb. A positive, although not significant, trend in terms of muscle strength and upper limb dexterity was observed, for both limbs, in the control group after the two-week treatment. Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT. Moreover, in the CIMT group, a non-significant worsening of muscle strength was recorded for the less affected upper limb.",2019,Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT.,"['progressive multiple sclerosis patients', 'Ten patients with MS (4 males, 6 females; mean age 51.0±7.7 years', 'MS patients', 'Patients affected by MS, and reporting reduced use primarily of one upper limb', 'patients affected by progressive MS']","['CIMT', 'Constraint-Induced Movement Therapy', 'constraint-induced movement therapy (CIMT', 'limb immobilized by a splint, and a control group, submitted to intensive bi-manual treatment']","['endpoint error and arm trajectory mean speed', 'muscle strength and upper limb dexterity', 'Hand Grip Strength Test (HGS) and 9-Hole Peg Test (9HPT', 'muscle strength', 'movement smoothness, measured by means of a bidimensional kinematic evaluation', 'upper limb activity']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0579116', 'cui_str': 'Upper limb activities'}]",10.0,0.0285574,Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mauro', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priano', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baudo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bigoni', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': ''}]",Functional neurology,[]
2668,32469156,Diuretic and Renal Effects of Spironolactone and Heart Failure Hospitalizations: A TOPCAT Americas Analysis.,"AIMS


It is unclear whether spironolactone reduced heart failure (HF) hospitalizations in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial through potential diuretic or other effects. We examined the effects of spironolactone on weight, diuretic use, and renal function, and their subsequent impact on outcomes.
METHODS AND RESULTS


We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm). We used mixed-effects models for serial data and shared frailty models to identify determinants of recurrent HF hospitalizations among baseline and serial parameters. There were 800 HF hospitalizations after a median of 3.0 years. Despite more weight loss with spironolactone initially, weight trajectories overlapped after 12 months. Daily furosemide dose (time-averaged Δ: -4.8% vs. +11.6%, P<0.001) and thiazide use (-4.3% vs. +1.7%; P=0.003) decreased with spironolactone; however, ACEi/ARB use decreased also (-13.1% vs. -7.3%; P=0.004). Serum creatinine increased more with spironolactone (+12.5% vs. +3.5%; P<0.001). In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations. However, the effect of spironolactone on HF hospitalizations persisted (HR 0.77; 95%CI: 0.62-0.96; P=0.021) in these models. Results were similar for cardiovascular mortality and time to first HF hospitalization.
CONCLUSIONS


In TOPCAT Americas, the benefit of spironolactone on outcomes could not be solely attributed to potential diuretic effects, suggesting the presence of non-diuretic mechanisms. This article is protected by copyright. All rights reserved.",2020,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","['We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm', 'and Heart Failure Hospitalizations']","['spironolactone', 'Daily furosemide', 'Spironolactone', 'Aldosterone Antagonist (TOPCAT', 'thiazide']","['weight, diuretic use, and renal function', 'weight trajectories', 'HF hospitalizations', 'heart failure (HF) hospitalizations', 'Serum creatinine', 'cardiovascular mortality and time to first HF hospitalization', 'weight loss', 'ACEi/ARB']","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]",1767.0,0.0687118,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","[{'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY.'}, {'ForeName': 'Jincy', 'Initials': 'J', 'LastName': 'Thankachen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT.'}]",European journal of heart failure,['10.1002/ejhf.1917']
2669,32469158,Comparative Analysis between Short Stem and Conventional Femoral Stem in Patients with Osteonecrosis of Femoral Head: Metha Stem and Excia Stem.,"OBJECTIVE


To compare the intraoperative, radiological, and clinical short-term outcomes of cementless total hip arthroplasties (THA) using a short stem (SS) and a conventional femoral stem (CS) in a randomized prospective control study.
METHODS


From June 2011 to October 2017, patients who underwent cementless THA for idiopathic osteonecrosis of the femoral head were recruited. Patients had a minimum 2 years of follow-up after the operation. The patients were divided into two groups: those who underwent THA using an SS and those who underwent THA using a CS. SS were used in 34 patients (41 hips) and CS were used in 41 patients (45 hips). In both groups, the same cup was used in all cases, and the mean follow-up periods were 63 (26-101) months in the SS and 64 (26-101) months in the CS groups. Intraoperative, clinical, and radiological evaluations were performed for the two groups.
RESULTS


There was no difference in the demographics of the two groups. There was one patient with a proximal femoral crack in the SS group and one with a distal femoral crack in the CS group. Clinically, the mean Harris hip score was improved in both groups at 2-year follow-up. Radiographically endosteal osseointegrations were found in 40 of 41 cases in the SS group and in 44 of 45 cases in the CS group. There was one case of dislocation in each group. In the SS group, the acetabular cup was changed and repositioned 7 months after the initial operation. Stem loosening, infection, ceramic breakage, and varus/valgus change were not observed. There was a statistically significant lower stress shielding effect in the SS group. There were no differences in vertical/parallel offset and leg length discrepancy.
CONCLUSION


The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.",2020,"The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.","['From June 2011 to October 2017, patients who underwent cementless THA for idiopathic osteonecrosis of the femoral head were recruited', 'Patients with Osteonecrosis of Femoral Head']","['cementless total hip arthroplasties (THA) using a short stem (SS) and a conventional femoral stem (CS', 'Short Stem and Conventional Femoral Stem', 'THA using an SS and those who underwent THA using a CS']","['Radiographically endosteal osseointegrations', 'Stem loosening, infection, ceramic breakage, and varus/valgus change', 'vertical/parallel offset and leg length discrepancy', 'proximal femoral crack', 'mean Harris hip score', 'stress shielding effect', 'acetabular cup', 'distal femoral crack']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",,0.015834,"The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.","[{'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Hyeon Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Ki Woong', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Dong Kang Hospital, Ulsan, South Korea.'}, {'ForeName': 'Young Hun', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Si Young', 'Initials': 'SY', 'LastName': 'Heo', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}]",Orthopaedic surgery,['10.1111/os.12684']
2670,32469182,Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.,"BACKGROUND


Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. The drug may have efficacy in patients with HER2-positive advanced gastric cancer.
METHODS


In an open-label, randomized, phase 2 trial, we evaluated trastuzumab deruxtecan as compared with chemotherapy in patients with HER2-positive advanced gastric cancer. Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including trastuzumab, were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan (6.4 mg per kilogram of body weight every 3 weeks) or physician's choice of chemotherapy. The primary end point was the objective response, according to independent central review. Secondary end points included overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety.
RESULTS


Of 187 treated patients, 125 received trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel). An objective response was reported in 51% of the patients in the trastuzumab deruxtecan group, as compared with 14% of those in the physician's choice group (P<0.001). Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]). The most common adverse events of grade 3 or higher were a decreased neutrophil count (in 51% of the trastuzumab deruxtecan group and 24% of the physician's choice group), anemia (38% and 23%, respectively), and decreased white-cell count (21% and 11%). A total of 12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee. One drug-related death (due to pneumonia) was noted in the trastuzumab deruxtecan group; no drug-related deaths occurred in the physician's choice group.
CONCLUSIONS


Therapy with trastuzumab deruxtecan led to significant improvements in response and overall survival, as compared with standard therapies, among patients with HER2-positive gastric cancer. Myelosuppression and interstitial lung disease were the notable toxic effects. (Funded by Daiichi Sankyo; DESTINY-Gastric01 ClinicalTrials.gov number, NCT03329690.).",2020,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","['12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee', 'patients with HER2-positive gastric cancer', 'patients with HER2-positive advanced gastric cancer', '187 treated patients', 'Previously Treated HER2-Positive Gastric Cancer', 'Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including']","['trastuzumab', 'trastuzumab deruxtecan', 'trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel', ""physician's choice of chemotherapy"", 'Trastuzumab Deruxtecan', 'chemotherapy']","['overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety', 'neutrophil count', 'Overall survival', 'objective response', 'anemia', 'Myelosuppression and interstitial lung disease', 'white-cell count', 'response and overall survival']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",187.0,0.240051,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hyun-Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kojima', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugihara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004413']
2671,32469183,Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.,"BACKGROUND


Injectable luteinizing hormone-releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known.
METHODS


In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. Secondary end points included noninferiority with respect to the primary end point, castrate levels of testosterone on day 4, and profound castrate levels (<20 ng per deciliter) on day 15. Testosterone recovery was evaluated in a subgroup of patients.
RESULTS


A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88).
CONCLUSIONS


In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).",2020,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"['Advanced Prostate Cancer', 'men with advanced prostate cancer', '622 patients received relugolix and 308 received', 'patients with advanced prostate cancer']","['luteinizing hormone-releasing hormone agonists (e.g., leuprolide', 'Oral Relugolix', 'leuprolide', 'relugolix']","['castrate levels of testosterone on day 4, and profound castrate levels', 'Testosterone recovery', 'sustained testosterone suppression to castrate levels', 'mean testosterone levels', 'incidence of major adverse cardiovascular events', 'castrate levels of testosterone', 'superiority of relugolix over leuprolide', 'noninferiority and superiority of relugolix']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]",622.0,0.384751,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Saltzstein', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'van Veenhuyzen', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Selby', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kang', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Walling', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004325']
2672,32469373,A Randomized Controlled Trial of Power Posing on Timed Up and Go Test.,"BACKGROUND


Integrating psychological principles into physical therapy treatment may enhance patient outcomes. One intervention strategy from psychological perspectives that could be integrated in physical therapy practice is power posing. There is a lack of research on the effects of power posing on functional outcomes commonly used in physical therapy.
OBJECTIVE


To determine the effects of power posing on the timed up and go test score.
DESIGN


Randomized controlled trial.
METHODS


Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately 1 foot apart for 20 s. Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 s. Timed up and go test was administered using an OmniVR Virtual Rehabilitation System before and after the postural intervention.
RESULTS


The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
CONCLUSIONS


The timed up and go test scores for both experimental and control groups improved slightly. However, the results did not show significant effects of power posing in the timed up and go test scores.",2020,"The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
","['Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately 1 foot apart for 20 s. Subjects in the']",['control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 s'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",[],20.0,0.026404,"The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
","[{'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Ge', 'Affiliation': 'Dep. of Physical Therapy, Youngstown State University, One University Plaza, Youngstown, OH 44555, USA. Tel 330-941-2702, fax 330-941-1898. wge@ysu.edu.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Schaefer', 'Affiliation': ''}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Basile', 'Affiliation': ''}]",Journal of allied health,[]
2673,32469375,Mind Mapping to Enhance Critical Thinking Skills in Physician Assistant Education: A Randomized Controlled Study.,"Physician assistant (PA) students need to assimilate and integrate voluminous information quickly and effectively to promote critical thinking skills required to deliver competent care. Mind mapping (MM) is an innovative strategy used to facilitate students' recognition and recall of essential information and to ensure depth in their understanding via making connections between pieces of information. The establishment of relationships between concepts expressed in mind maps enhances critical thinking skills. The purpose of this study was to determine the overall critical thinking skills of PA students using MM as a learning strategy and to determine if there was a significant difference in critical thinking skills between students who used MM versus standard note-taking in their learning environment. In this randomized control study, a convenience sample of 74 PA students was assigned to a standard note-taking group (SNTG) or mind-mapping group (MMG). After completing the Health Science Reasoning Test (pre-HSRT), MMG members were instructed on how to construct mind maps and then asked to create weekly mind maps for 9 weeks, while the SNTG followed their method of study without mind maps for 9 weeks. Differences in the mean pre- and post-overall HSRT scores between groups and within groups were analyzed using independent and dependent t-tests, respectively. There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups. However, there was a significant difference in the mean overall post-HSRT scores between groups (p=0.026). Hence, mind mapping is a viable active learning strategy to promote critical thinking in PA students.",2020,There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups.,"['Physician Assistant Education', 'students who used MM versus standard note-taking in their learning environment', 'convenience sample of 74 PA students']","['standard note-taking group (SNTG) or mind-mapping group (MMG', 'Mind mapping (MM']","['pre- and post-overall critical thinking scores', 'mean overall post-HSRT scores', 'mean pre- and post-overall HSRT scores', 'critical thinking skills', 'overall critical thinking skills']","[{'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",74.0,0.0511298,There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Israel', 'Affiliation': 'School of Graduate Studies, Rutgers, Biomedical Sciences, 675 Hoes Lane, Research Tower Rm 102, Piscataway, NJ 08854, USA. Tel 732-407-5724. israelcyn@gmail.com.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Pinto Zipp', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""D'Abundo"", 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Deluca', 'Affiliation': ''}]",Journal of allied health,[]
2674,32469381,"Effects of Lower Body Positive Pressure Treadmill Training on Balance, Mobility and Lower Extremity Strength of Community-Dwelling Older Adults: A Pilot Study.","AIM


There is growing evidence that confirms the benefits of partially supporting a person's body weight during exercise. Lower body positive pressure (LBPP) unweighting is a new method of providing partial body weight support. This pilot study aims to investigate the effect of LBPP treadmill training on balance, mobility and lower extremity strength in community-dwelling older adults.
SUBJECTS


Five community-dwelling females aged 60-85 years with no neurological conditions or musculoskeletal injuries within the past year.
METHODS


The subjects participated in twice-weekly treadmill training sessions using LBPP at 80% of body weight. They exercised using their self-selected speed and incline for 20 min each session for 8 wks. Pre- and post-test measures included measures of balance, mobility and lower extremity strength.
RESULTS


Average self-selected speed more than doubled from initial to final training session. All subjects exercised within their safe limits, with no unsafe increases in blood pressure or heart rate, and no complaints of extremity pain or muscle soreness throughout the entire training period. Wilcoxon signed ranks test results showed statistically significant improvement in lower extremity strength.
CONCLUSIONS


In a sample of community-dwelling older adult females, an 8-wk regimen of treadmill exercise with LBPP unweighing resulted in improvements in lower extremity strength. The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults. Improvement in lower extremity strength may have significant implications in maintaining balance and mobility and decreasing fall risk in this population.",2020,The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults.,"['community-dwelling older adults', 'Five community-dwelling females aged 60-85 years with no neurological conditions or musculoskeletal injuries within the past year', 'community-dwelling older adult females', 'Community-Dwelling Older Adults']","['Lower Body Positive Pressure Treadmill Training', 'treadmill exercise with LBPP unweighing', 'LBPP treadmill training']","['blood pressure or heart rate, and no complaints of extremity pain or muscle soreness', 'lower extremity strength', 'measures of balance, mobility and lower extremity strength', 'Balance, Mobility and Lower Extremity Strength', 'balance, mobility and lower extremity strength']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C1444637', 'cui_str': 'Past'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424577', 'cui_str': 'No complaints'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0112188,The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults.,"[{'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Lazaro', 'Affiliation': 'California State University Sacramento, 6000 J Street MS 6020, Sacramento, CA 95819, USA. Tel 916-278-5054, fax 916-278-6842. rolando.lazaro@csus.edu.'}]",Journal of allied health,[]
2675,32469384,Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial.,"Importance


Papillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group.
Objective


To determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib.
Design, Setting, and Participants


The SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened, to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened.
Interventions


Patients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability.
Results


At data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy.
Conclusions and Relevance


Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT03091192.",2020,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","['360 to 450 patients were to be screened, to randomize approximately 180 patients', 'Importance\n\n\nPapillary renal cell carcinoma ', '32 centers in 7 countries between July 2017 and the data cutoff in August 2019', '60 patients were randomized (savolitinib n\u2009=\u200933', '254 patients were screened', 'Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment', 'patients with MET-driven disease, study enrollment was closed', 'Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions', 'Patients With MET-Driven Papillary Renal Cell Carcinoma']","['PRCC', 'Savolitinib vs Sunitinib']","['progression-free survival (PFS', 'Median PFS', 'overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability', 'Progression-free survival, OS, and ORR']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.307135,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Cancel', 'Affiliation': 'CHU Bretonneau Centre, Tours University, France.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Ottesen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Oncology R&D, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Hernault"", 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szijgyarto', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2218']
2676,32469385,Survival Outcomes Associated With 3 Years vs 1 Year of Adjuvant Imatinib for Patients With High-Risk Gastrointestinal Stromal Tumors: An Analysis of a Randomized Clinical Trial After 10-Year Follow-up.,"Importance


Adjuvant imatinib is associated with improved recurrence-free survival (RFS) when administered after surgery to patients with operable gastrointestinal stromal tumor (GIST), but its influence on overall survival (OS) has remained uncertain.
Objective


To evaluate the effect of adjuvant imatinib on OS of patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery.
Design, Setting, and Participants


In this open-label, randomized (1:1), multicenter phase 3 clinical trial conducted in Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008. Data for this follow-up analysis were analyzed from September to November, 2019.
Interventions


Imatinib 400 mg/d administered orally for either 12 months or 36 months after surgery.
Main Outcomes And Measures


The primary end point was RFS; the secondary objectives included OS and treatment safety.
Results


The intention-to-treat cohort consisted of 397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat Population. Five-year and 10-year RFS was 71.4% and 52.5%, respectively, in the 36-month group and 53.0% and 41.8% in the 12-month group (hazard ratio [HR], 0.66; 95% CI, 0.49-0.87; P = .003). In the 36-month group, 5-year OS and 10-year OS rates were 92.0% and 79.0%, respectively, and in the 12-month group 85.5% and 65.3% (HR, 0.55; 95% CI, 0.37-0.83; P = .004). The results were similar in the efficacy population, from which 15 patients who did not have GIST in central pathology review and 24 patients who had intra-abdominal metastases removed at surgery were excluded (36-month group, 10-year OS 81.6%; 12-month group, 66.8%; HR, 0.50; 95% CI, 0.32-0.80; P = .003). No new safety signals were detected.
Conclusions and Relevance


Three years of adjuvant imatinib is superior in efficacy compared with 1 year of imatinib. Approximately 50% of deaths may be avoided during the first 10 years of follow-up after surgery with longer adjuvant imatinib treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT00116935.",2020,"No new safety signals were detected.
","['Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008', 'patients with operable gastrointestinal stromal tumor (GIST', 'Patients With High-Risk Gastrointestinal Stromal Tumors', 'patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery', '397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat Population']",['adjuvant imatinib'],"['intra-abdominal metastases', '10-year RFS', '5-year OS and 10-year OS rates', 'recurrence-free survival (RFS', 'Survival Outcomes', 'overall survival (OS', 'RFS; the secondary objectives included OS and treatment safety']","[{'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0854198', 'cui_str': 'Metastases to abdominal cavity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",400.0,0.296023,"No new safety signals were detected.
","[{'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Oncology, Skåne University Hospital and Lund University, Lund, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sundby Hall', 'Affiliation': 'Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schütte', 'Affiliation': 'Schwerpunktpraxis Oncology/Hematology, Düsseldorf, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Department of Gastroenterology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Philipp J', 'Initials': 'PJ', 'LastName': 'Jost', 'Affiliation': 'Medical Department III, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Klinik für Onkologie und Hämatologie am Krankenhaus Nordwest, Frankfurt, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Sarcoma Center, West German Cancer Center, Essen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard-Domagk-Institute of Pathology, University of Münster, Münster, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Kallio', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Jaakkola', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': '4Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Alvegård', 'Affiliation': 'Department of Cancer Epidemiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2091']
2677,32469388,Dietary protein intake does not modulate daily myofibrillar protein synthesis rates or loss of muscle mass and function during short-term immobilization in young men: a randomized controlled trial.,"BACKGROUND


Short-term (<1 wk) muscle disuse lowers daily myofibrillar protein synthesis (MyoPS) rates resulting in muscle mass loss. The understanding of how daily dietary protein intake influences such muscle deconditioning requires further investigation.
OBJECTIVES


To assess the influence of graded dietary protein intakes on daily MyoPS rates and the loss of muscle mass during 3 d of disuse.
METHODS


Thirty-three healthy young men (aged 22 ± 1 y; BMI = 23 ± 1 kg/m2) initially consumed the same standardized diet for 5 d, providing 1.6 g protein/kg body mass/d. Thereafter, participants underwent a 3-d period of unilateral leg immobilization during which they were randomly assigned to 1 of 3 eucaloric diets containing relatively high, low, or no protein (HIGH: 1.6, LOW: 0.5, NO: 0.15 g protein/kg/d; n = 11 per group). One day prior to immobilization participants ingested 400 mL deuterated water (D2O) with 50-mL doses consumed daily thereafter. Prior to and immediately after immobilization upper leg bilateral MRI scans and vastus lateralis muscle biopsies were performed to measure quadriceps muscle volume and daily MyoPS rates, respectively.
RESULTS


Quadriceps muscle volume of the control legs remained unchanged throughout the experiment (P > 0.05). Immobilization led to 2.3 ± 0.4%, 2.7 ± 0.2%, and 2.0 ± 0.4% decreases in quadriceps muscle volume (P < 0.05) of the immobilized leg in the HIGH, LOW, and NO groups (P < 0.05), respectively, with no significant differences between groups (P > 0.05). D2O ingestion resulted in comparable plasma free [2H]-alanine enrichments during immobilization (∼2.5 mole percentage excess) across groups (P > 0.05). Daily MyoPS rates during immobilization were 30 ± 2% (HIGH), 26 ± 3% (LOW), and 27 ± 2% (NO) lower in the immobilized compared with the control leg, with no significant differences between groups (P > 0.05).
CONCLUSIONS


Three days of muscle disuse induces considerable declines in muscle mass and daily MyoPS rates. However, daily protein intake does not modulate any of these muscle deconditioning responses.Clinical trial registry number: NCT03797781.",2020,"RESULTS


Quadriceps muscle volume of the control legs remained unchanged throughout the experiment (P > 0.05).","['Thirty-three healthy young men (aged 22\xa0±\xa01 y; BMI = 23\xa0±\xa01 kg/m2', 'young men']","['graded dietary protein intakes', 'immobilization participants ingested 400 mL deuterated water (D2O) with 50-mL doses consumed daily thereafter', 'unilateral leg immobilization', 'eucaloric diets containing relatively high, low, or no protein (HIGH: 1.6, LOW: 0.5, NO', 'Dietary protein intake']","['Daily MyoPS rates', 'quadriceps muscle volume', 'plasma free [2H]-alanine enrichments', 'daily MyoPS rates', 'muscle mass and daily MyoPS rates', 'quadriceps muscle volume and daily MyoPS rates', 'Quadriceps muscle volume of the control legs']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",33.0,0.0314115,"RESULTS


Quadriceps muscle volume of the control legs remained unchanged throughout the experiment (P > 0.05).","[{'ForeName': 'Sean Paul', 'Initials': 'SP', 'LastName': 'Kilroe', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Science, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fulford', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jackman', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Science, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Holwerda', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Annemie', 'Initials': 'A', 'LastName': 'Gijsen', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Benjamin Toby', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Science, University of Exeter, Exeter, UK.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa136']
2678,32469393,"Effects of a multinutrient-fortified milk drink combined with exercise on functional performance, muscle strength, body composition, inflammation, and oxidative stress in middle-aged women: a 4-month, double-blind, placebo-controlled, randomized trial.","BACKGROUND


Multinutrient protein-enriched supplements are promoted to augment the effects of exercise on muscle mass and strength, but their effectiveness in middle-aged women, or whether there are any additional benefits to physical function, remains uncertain.
OBJECTIVES


We aimed to evaluate whether a multinutrient-fortified milk drink (MFMD) could enhance the effects of exercise on functional muscle power (stair climbing) in middle-aged women. Secondary aims were to evaluate the intervention effects on physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids.
METHODS


In this 4-mo, double-blind, placebo-controlled, randomized trial, 244 women (45-65 y) participated in a multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex + MFMD, n = 123) or an energy-matched placebo (Ex + placebo, n = 121).
RESULTS


A total of 216 women (89%) completed the study. After 4 mo, both groups experienced similar 3.6%-4.3% improvements in the primary outcomes of fast-pace 5- and 10-step stair ascent power. In contrast, Ex + MFMD experienced greater improvements in 5-step regular-pace stair descent time [net difference (95% CI): -0.09 s (-0.18, 0.00 s), P = 0.045], countermovement jump height [0.5 cm (0.04, 1.0 cm), P = 0.038], total body LM [0.3 kg (0.04, 0.60 kg), P = 0.020], FM [-0.6 kg (-1.0, -0.2 kg), P = 0.004], BMC [0.4% (0.1%, 0.6%), P = 0.020], muscle CSA [thigh: 1.8% (0.6%, 2.9%), P = 0.003; lower leg: 0.9% (0.3%, 1.6%), P = 0.005], balance eyes closed [3.3 s (1.1, 5.4 s), P = 0.005], 2-min step performance [8 steps (3, 12 steps), P = 0.003], and sit-and-reach flexibility [1.4 cm (0.6, 2.2 cm), P = 0.026]. MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover. Ex + placebo had a greater improvement in the oxidative stress marker protein carbonyls (P < 0.01).
CONCLUSIONS


In middle-aged women, daily consumption of an MFMD did not enhance the effects of a multimodal exercise program on the primary outcome of stair climbing ascent power, but did elicit greater improvements in multiple secondary outcomes including various other measures of functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism.This trial was registered at www.anzctr.org.au as ACTRN12617000383369.",2020,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","['middle-aged women', '216 women (89%) completed the study', '244 women (45-65 y) participated in a']","['multinutrient-fortified milk drink combined with exercise', 'MFMD', 'multimodal exercise program', 'multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex\xa0+\xa0MFMD, n\xa0=\xa0123) or an energy-matched placebo (Ex\xa0+\xa0placebo, n\xa0=\xa0121', 'multinutrient-fortified milk drink (MFMD', 'Ex\xa0+\xa0placebo', 'placebo']","['physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids', 'functional performance, muscle strength, body composition, inflammation, and oxidative stress', 'countermovement jump height', 'sit-and-reach flexibility', 'BMC', 'oxidative stress marker protein carbonyls', 'blood pressure, markers of inflammation, or cartilage turnover', 'functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism', 'fast-pace 5- and 10-step stair ascent power', 'total body LM', 'muscle strength, gait speed, dynamic balance, reaction time, or blood lipids', 'functional muscle power (stair climbing', '5-step regular-pace stair descent time']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",244.0,0.577968,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'De Ross', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Kruger', 'Affiliation': 'School of Health Sciences, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schollum', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gunn', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa126']
2679,32469398,Effect of lean red meat combined with a multicomponent exercise program on muscle and cognitive function in older adults: a 6-month randomized controlled trial.,"BACKGROUND


Exercise and increased dietary protein have been linked to improved muscle and cognitive health, but the combination may be more effective.
OBJECTIVE


In this study performed in community-dwelling older adults undergoing a 3-d/wk resistance-based exercise training program, we investigated whether those who consumed lean red meat compared to carbohydrates on the 3 training days per wk would experience greater exercise-induced improvements in total body and leg lean mass (LM), muscle strength, and executive function (multiple primary outcomes), as well as muscle size and density, functional performance, cognition, inflammatory and neurotrophic markers, blood pressure, and lipid concentrations.
DESIGN


In a 24-wk, 2-arm parallel randomized controlled trial, 154 adults aged ≥65 y participated in a multicomponent 3-d/wk resistance-based exercise program with random allocation to either a lean red meat group (two 80-g servings of cooked red meat), the exercise plus lean red meat (Ex + Meat) group (n = 77) or a control group receiving carbohydrates in the form of one-half cup (approximately 225 g cooked weight) of rice or pasta or 1 medium potato, the exercise plus carbohydrate control (C + Ex) group (n = 77), on the training days.
RESULTS


Exercise-induced improvements (mean within group changes) did not significantly differ between groups for the primary outcomes of total body LM (0.6 to 0.8 kg), leg LM (0.1 to 0.2 kg), thigh muscle cross-sectional area (3.7% to 4.9%), leg and back muscle strength (26% to 40%), and executive function (z-score SD: 0.33 to 0.39), nor the secondary outcomes of global cognition function (0.17 to 0.23 SD), fat mass (-0.65 to -0.75 kg), physical function measures (sit-to-stand, both 15%; 4-square step test, 2% to 7%), or systolic blood pressure (-3.2 to -4.1 mm Hg). The Ex + Meat group experienced greater improvements than the C + Ex in arm LM (0.07 kg; 95% CI: 0.01, 0.14; P = 0.029), gait speed (0.05 m/s; 95% CI: 0.00, 0.11; P = 0.042), muscle density (1.0%; 95% CI: 0.2, 1.9; P = 0.015), and appendicular LM in the per-protocol analysis (0.21 kg; 95% CI: 0.02, 0.40; P = 0.03). The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007). Inflammatory and neurotrophic markers did not change in either group.
CONCLUSION


In healthy community-dwelling older adults undertaking resistance-based exercise training 3-d/wk, participants who consumed lean red meat in line with current Australian dietary recommendations did not experience any significant additional benefits in the primary outcome measures of muscle mass, strength, or cognitive function compared to participants consuming carbohydrates.This trial is registered with the Australian and New Zealand Clinical Trials Registry as ACTRN12613001153707.",2020,"The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007).","['healthy community-dwelling older adults undertaking', 'community-dwelling older adults undergoing a', 'older adults', '154 adults aged ≥65 y participated in a']","['lean red meat combined with a multicomponent exercise program', '3-d/wk resistance-based exercise training program', 'multicomponent 3-d/wk resistance-based exercise program with random allocation to either a lean red meat group (two 80-g servings of cooked red meat), the exercise plus lean red meat (Ex +\xa0Meat) group (n = 77) or a control group receiving carbohydrates in the form of one-half cup (approximately 225 g cooked weight) of rice or pasta or 1 medium potato, the exercise plus carbohydrate control (C\xa0+\xa0Ex', 'resistance-based exercise training 3-d/wk, participants who consumed lean red meat in line with current Australian dietary recommendations']","['muscle and cognitive function', 'muscle density', 'muscle mass, strength, or cognitive function', 'Inflammatory and neurotrophic markers', 'thigh muscle cross-sectional area', 'gait speed', 'leg and back muscle strength', 'executive function', 'total body LM', 'working memory/learning', 'fat mass', 'physical function measures', 'total body and leg lean mass (LM), muscle strength, and executive function (multiple primary outcomes), as well as muscle size and density, functional performance, cognition, inflammatory and neurotrophic markers, blood pressure, and lipid concentrations', 'global cognition function', 'leg LM', 'systolic blood pressure', 'appendicular LM']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0452848', 'cui_str': 'Red meat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",154.0,0.167933,"The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007).","[{'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Formica', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Caryl A', 'Initials': 'CA', 'LastName': 'Nowson', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Milte', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Neurodegeneration Division, The Florey Institute, Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa104']
2680,32469406,Effect of the Timing of Antiretroviral Treatment Initiation on Outcomes in Children Living With Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition.,"BACKGROUND


Delays in early infant diagnosis and antiretroviral treatment (ART) initiation in developing countries frequently result in malnutrition at initial presentation with associated higher mortality and delayed immune recovery. The optimal timing of ART initiation is yet to be established.
METHODS


Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled. Patients were randomized to initiate ART within 14 days from admission (early arm) or delay ART initiation until nutritional recovery and >14 days after admission (delayed arm). All patients received a standardized treatment and feeding protocol and were followed to 48 weeks.
RESULTS


The mean age of the patients at baseline was 23.3 months (standard deviation [SD], 27.9; range, 1.6-129 months). The mean time from admission to ART initiation was 5.6 days (SD, 4.4) in the early arm and 23 days (SD, 5.8) in the delayed arm (P < .001). There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks. However, the rates of change in CD4, viral load, weight for age z score, and height for age z score occurred earlier and favored the delayed arm at early time points but were not significant at 24 and 48 months.
CONCLUSIONS


Despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.In this randomised controlled study of ART initiation in children admitted with HIV and severe acute malnutrition (SAM), despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.
CLINICAL TRIALS REGISTRATION


PACTR 21609001751384.",2020,"There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks.","['children living with HIV admitted with SAM', 'Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled', 'Children Living With', 'Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition', 'children admitted with HIV and severe acute malnutrition (SAM', 'children living with HIV admitted with SAM.In']",['Antiretroviral Treatment Initiation'],"['mean time from admission to ART initiation', 'rates of change in CD4, viral load, weight for age z score, and height for age z score', 'virologic response', 'mortality', 'anthropometric response']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",82.0,0.233894,"There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks.","[{'ForeName': 'Moherndran', 'Initials': 'M', 'LastName': 'Archary', 'Affiliation': 'Paediatric Unit, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Benn', 'Initials': 'B', 'LastName': 'Sartorius', 'Affiliation': 'School of Nursing and Public Health, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'La Russa', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Thobekile', 'Initials': 'T', 'LastName': 'Sibaya', 'Affiliation': 'Department of Paediatrics and Child Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Healy', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Columbia University, New York, New York, USA.'}, {'ForeName': 'Raziya A', 'Initials': 'RA', 'LastName': 'Bobat', 'Affiliation': 'Paediatric Unit, King Edward VIII Hospital, Durban, South Africa.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa054']
2681,32469414,Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease: A Qualitative Study.,"Importance


Bone marrow transplant (BMT) is a potentially curative treatment for sickle cell disease (SCD). Patient and caregiver attitudes toward BMT for SCD and the willingness to accept risks of BMT vary, but these attitudes are not well understood.
Objective


To understand patient and caregiver perceptions of and attitudes toward BMT for SCD and decision-making about BMT.
Design, Setting, and Participants


Qualitative study of interview transcripts from a convenience sample. Transcripts were from adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities. Interview transcripts were used from the needs assessment phase to develop a patient-decision aid in 2013 to 2014 (group 1) and from the baseline point in 2015 to 2016 (group 2) of the parent trial, a randomized clinical trial of adults and caregivers of patients with SCD to evaluate the effectiveness of a patient decision aid.
Main Outcomes and Measures


Participant perspectives on decision-making regarding BMT for SCD.
Results


Fifty-seven transcripts from adults with SCD and 50 transcripts from caregivers of patients with SCD were included. Median (interquartile range [IQR]) age of adults with SCD was 34 (21-50) years in group 1 and 30 (23-38) years in group 2. The median (IQR) age of caregivers was 42.5 (31-52) years in group 1 and 41 (35-46.5) years in group 2. Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants. Bone marrow transplant was perceived as a treatment option associated with serious risks. Reported attitudes toward BMT occurred on a continuum ranging from unfavorable to favorable. Participants reported serious decisional dilemma regarding BMT for SCD. Most participants expressed interest in learning about BMT or curative treatments.
Conclusions and Relevance


This qualitative study found a continuum in attitudes toward BMT for SCD and highlights the complexity of decision-making in BMT for SCD. Patients and families with SCD expressed an interest in learning about BMT. Future prospective studies of patient decision-making regarding BMT, especially in the context of emerging curative and novel disease-modifying therapies for SCD, are warranted.",2020,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"['adults with SCD and 50 transcripts from caregivers of patients with SCD', 'sickle cell disease (SCD', 'adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities', 'Sickle Cell Disease']",['Importance\n\n\nBone marrow transplant (BMT'],['decision-making regarding BMT for SCD'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",,0.0344463,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"[{'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Katoch', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6742']
2682,32469454,Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression.,"BACKGROUND


Parenting in early childhood exerts substantial influence over children's emotional health and development. Using data from a randomized controlled trial of a novel treatment for early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED), we explored two broad dimensions of parenting (behavior and affect) to determine whether any changes could be detected following treatment when compared to those in a waitlist control condition.
METHOD


229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a waitlist completed two structured interaction tasks at baseline and post-treatment. Interactions were later coded by observer's blind to diagnostic and treatment status.
RESULTS


Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group. Increases in the overall positivity of the observed interactional style of caregivers, but no observed parenting behavior change was found following treatment. Discrepancies between self-reported and observed parenting were greater among caregivers on the waitlist.
CONCLUSIONS


Following PCIT-ED treatment, caregivers self-reported improvements in parenting practices and declines in punitive practices along with observed increases in positive affect and decreases in negative affect when interacting with their child. Moreover, coherence between self-reported and observed parenting was higher in the treatment group. These findings highlight the efficacy of PCIT-ED in improving parenting behaviors and the need to use multiple methods to assess parenting in treatment studies.",2020,"RESULTS


Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","['early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED', 'preschool depression', '229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a']","['waitlist completed two structured interaction tasks at baseline and post-treatment', 'PCIT-ED', 'parent-child interaction therapy']","['self-reported positive parenting behaviors', 'coherence between self-reported and observed parenting', 'parenting behaviors', 'negative parenting behaviors', 'parenting behavior change']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",229.0,0.0498308,"RESULTS


Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13263']
2683,32463701,Effects of Transcranial Direct Current Stimulation on Visual Neuroplasticity in Schizophrenia.,"People with schizophrenia (SZ) exhibit visual processing abnormalities that affect their daily functioning and remediating these deficits might help to improve functioning. Transcranial direct current stimulation (tDCS) is a potential tool for perceptual enhancement for this purpose, though there are no reports of tDCS applied to visual cortex in SZ. In a within-subject, crossover design, we evaluated the effects of tDCS on visual processing in 27 SZ. All patients received anodal, cathodal, or sham stimulation over the central occipital region in 3 visits separated by 1 week. In each visit, a backward masking task and an electroencephalography measure of visual neuroplasticity were administered after tDCS. Neuroplasticity was assessed with visual evoked potentials before and after tetanizing visual high-frequency stimulation. Masking performance was significantly poorer in the anodal and cathodal conditions compared with sham. Both anodal and cathodal stimulation increased the amplitude of P1 but did not change the plasticity index. We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons. The reason for the lack of tDCS stimulation effects on plasticity may be because tDCS was not delivered simultaneously with the tetanizing visual stimulus. The present findings emphasize the need for more research on the relevant parameters for stimulation of visual processing regions in clinical populations.",2020,We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons.,"['27 SZ', 'People with schizophrenia (SZ', 'Schizophrenia']","['Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS', 'anodal, cathodal, or sham stimulation']","['Visual Neuroplasticity', 'amplitude of P1', 'Neuroplasticity', 'visual processing', 'Masking performance']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",,0.0630777,We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons.,"[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jahshan', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Wynn', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'San Francisco Department of Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'San Francisco Department of Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}]",Clinical EEG and neuroscience,['10.1177/1550059420925697']
2684,32463741,Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W.,"PURPOSE


NCI-MATCH is a nationwide, histology-agnostic, signal-finding, molecular profile-driven trial for patients with refractory cancers, lymphomas, or myelomas. Patients with tumors harboring actionable aberration(s) in fibroblast growth factor receptor ( FGFR )  1-3  were treated with AZD4547, an oral FGFR1-3 inhibitor.
METHODS


Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions. Patients were treated with AZD4547, 80 mg orally twice daily until progression of disease or drug intolerance. A response rate of 16% was considered promising.
RESULTS


Between July 2016 and June 2017, 70 patients were assigned and 48 received protocol therapy and are eligible for analysis. Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or  FGFR3  single-nucleotide variants (n = 19), or  FGFR1  or  FGFR3  fusions (n = 9). The most common primary tumors were breast (33.3%), urothelial (12.5%), and cervical cancer (10.4%).Grade 3 adverse events were consistent with those described in previous clinical trials. Confirmed partial responses were seen in 8% (90% CI, 3% to 18%) and were observed only in patients whose tumors harbored  FGFR1-3  point mutations or fusions. Stable disease was observed in 37.5% (90% CI, 25.8% to 50.4%). The median progression-free survival (PFS) was 3.4 months, and the 6-month PFS rate was 15% (90% CI, 8% to 31%). For patients with tumors harboring  FGFR  fusions, the response rate was 22% (90% CI, 4.1% to 55%), and 6-month PFS rate was 56% (90% CI, 31% to 100%).
CONCLUSION


Preliminary signals of activity appeared to be limited to cancers harboring  FGFR  activating mutations and fusions, although AZD4547 did not meet the primary end point. Different  FGFR  somatic alterations may confer different levels of signaling potency and/or oncogene dependence.",2020,FGFR3  ,"[""Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions"", 'Patients With Tumors Harboring Aberrations in the FGFR Pathway', ""Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or"", 'patients with refractory cancers, lymphomas, or myelomas', 'Patients with tumors harboring actionable aberration(s', 'Between July 2016 and June 2017, 70 patients were assigned and 48 received']","['FGFR1  or  FGFR3  fusions', 'AZD4547', 'protocol therapy', 'FGFR3', 'AZD4547, an oral FGFR1-3 inhibitor', 'fibroblast growth factor receptor']","['Stable disease', 'median progression-free survival (PFS', 'cervical cancer', '6-month PFS rate', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0527057', 'cui_str': 'FGFR3 protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C2981795', 'cui_str': 'AZD4547'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",70.0,0.037636,FGFR3  ,"[{'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Chae', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Vaklavas', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Seattle Cancer Center Alliance, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hammerman', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Zwiebel', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'S Percy', 'Initials': 'SP', 'LastName': 'Ivy', 'Affiliation': 'Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Larry V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'Center for Biomedical Informatics & Information Technology, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Conley', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Lyndsay N', 'Initials': 'LN', 'LastName': 'Harris', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02630']
2685,32463786,Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial.,"INTRODUCTION


Data on the comparative effectiveness of Diabetes Prevention Programs (DPPs) in the workplace are limited.
METHODS


Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes (N = 158) were randomly assigned to one of 2 DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health (n = 80). The primary outcome was change in body weight assessed at 6 and 12 months. Follow-up ended in August 2017.
RESULTS


Both the YMCA-DPP and VLM-DPP yielded a significant reduction in percentage body weight at 6 months. For the YMCA-DPP, mean percentage change at 6 months was -2.70% (95% confidence interval [CI], -3.91% to -1.48%) and at 12 months was -2.46% (95% CI, -4.24% to -0.68%). For the VLM-DPP, mean percentage change at 6 months was -2.41% (95% CI, -4.07% to -0.77%) and at 12 months was -1.59% (95% CI, -3.51% to 0.33%). The mean between-condition difference at 6 months was -0.25% (95% CI, -2.04% to 1.55%) and at 12 months was -0.84% (95% CI, -3.03% to 1.34%). No significant differences were observed between conditions. The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months (mean between-condition difference -2.00 cm [95% CI, -4.24 to 0.25 cm]). Participant engagement, expressed as mean number of completed core program sessions, was significantly higher for the YMCA-DPP than the VLM-DPP. Participants of the YMCA-DPP completed an average of 10.2 sessions (95% CI, 9.0 to 11.4), and participants of the VLM-DPP completed an average of 5.9 sessions (95% CI, 4.7 to 7.1). The adjusted mean between-condition difference was 4.2 sessions (95% CI, 2.54 to 5.99).
CONCLUSION


Both the YMCA-DPP and VLM-DPP yielded weight loss at 6 months, which was maintained at 12 months in the YMCA-DPP. The workplace may be an effective setting to offer DPPs.",2020,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"['N = 158', 'Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes']","['2 Diabetes Prevention Lifestyle Programs', 'Diabetes Prevention Programs (DPPs', 'DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health']","['weight loss', 'change in body weight', 'waist circumference', 'percentage body weight']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",158.0,0.0835716,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612. Email: assiamira.ferrara@kp.org.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'McDonald', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Janet G', 'Initials': 'JG', 'LastName': 'Alexander', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Christian-Herman', 'Affiliation': 'Kaiser Foundation Health Plan, Oakland, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'San Francisco Health Service System, San Francisco, California.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}]",Preventing chronic disease,['10.5888/pcd17.190396']
2686,32464019,Comparative Evaluation of Bone Formation between PRF and Blood Clot Alone as the Sole Sinus-Filling Material in Maxillary Sinus Augmentation with the Implant as a Tent Pole: A Randomized Split-Mouth Study.,"The lack of bone volume in the posterior maxillary region can be augmented with sinus elevation. Since the elevated sinus is a closed cavity, a blood clot that fills the sinus space itself can aid in bone formation. The aim of this study was to compare bone formation in the elevated maxillary sinus between platelet-rich fibrin (PRF) and blood clot alone as the sole sinus-filling material with the implant as a tent pole. The study was a randomized controlled trial with a split-mouth design involving seven patients. An implant was placed on one side only and blood was allowed to fill the elevated sinus cavity; on the other side, PRF plugs were inserted. The sinus window was covered by nonresorbable titanium-reinforced membrane. The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor. A greater increase in distal bone height was seen in the control group. It was concluded that PRF may be more effective as a sole sinus-filling material in the elevated sinus cavity with an implant as a tent pole.",2019,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","['seven patients', 'Maxillary Sinus Augmentation with the Implant as a Tent Pole']","['PRF and Blood Clot Alone', 'PRF', 'platelet-rich fibrin (PRF) and blood clot alone']","['bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width', 'distal bone height', 'bone formation']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0337815', 'cui_str': 'Poles'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",7.0,0.0173919,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","[{'ForeName': 'Gurumoorthy', 'Initials': 'G', 'LastName': 'Kaarthikeyan', 'Affiliation': 'Department of Periodontics, Saveetha Dental College, Saveetha University, Chennai-77.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Jayakumar', 'Affiliation': 'Saveetha Dental College, Saveetha University, Chennai-77 India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sivakumar', 'Affiliation': 'Private Practitioner, Thirupur, India.'}]",Journal of long-term effects of medical implants,['10.1615/JLongTermEffMedImplants.2019031387']
2687,32464082,Comparison of the Effects of Two Cochlear Implant Fine Structure Coding Strategies on Speech Perception.,"Purpose This study aims to investigate the effect of upgrading from the fine structure processing (FSP) coding strategy to the novel fine structure strategy ""FS4"" in adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria). Method A crossover, double-blinded study was conducted for 12 weeks. Twelve adult participants were randomly assigned to two groups. During the first 6-week test interval, one group continued to use their everyday FSP strategy, whereas the other group was upgraded to the FS4 strategy. In the second 6-week interval, the two groups switched coding strategies. Speech perception was measured at the end of each test interval with the Oldenburg Sentence Test and the Göttingen Sentence Test. Participants completed the Speech, Spatial and Qualities of Hearing Scale at the end of each test interval and a simple preference test at the end of the study. Results There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise. Participants' Speech, Spatial and Qualities of Hearing Scale self-evaluation and preference test results showed that the two coding strategies had similar effects on their hearing perception. No clear preference for either of the strategies was found. Conclusions Speech perception test results and the participants' level of satisfaction were similar for the two FS coding strategies. Despite differences in the presentation of temporal fine structure between FSP and FS4, a clear benefit of the newer FS4 strategy could not be shown.",2020,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","['adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria', 'Twelve adult participants']","['fine structure processing (FSP', 'Two Cochlear Implant Fine Structure Coding Strategies']","['Speech Perception', 'speech perception test', 'Speech perception', 'Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise', 'Speech, Spatial and Qualities of Hearing Scale', 'hearing perception']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",12.0,0.0209095,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Heinz Dieter', 'Initials': 'HD', 'LastName': 'Klünter', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fürstenberg', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walger', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lang-Roth', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}]",American journal of audiology,['10.1044/2020_AJA-19-00110']
2688,32464140,Micro-CT evaluation of the shaping ability of three reciprocating single-file NiTi-systems on single- and double-curved root canals.,"AIM


Micro-CT assessment of preparation of moderately single- and double curved root canals using three single-file reciprocating NiTi-systems: S1 Plus Standard (Sendoline, Täby, Sweden; S1P), WaveOne Gold Primary (Dentsply Sirona, Ballaigues, Switzerland; WOG), Reciproc R25 (VDW, Munich, Germany; REC) MATERIALS AND METHODS: Seventy-five moderately curved mandibular molars with two separate mesial root canals were assigned to three experimental groups (n=25): S1P, WOG, REC by forming matched triples according to curvature (15-40°), radius (≤18 mm) and type of curvature (single- or double-curved). Teeth were scanned before and after root canal preparation with a resolution of 10.5 μm using micro-computed tomography (Bruker SkyScan 1272, Bruker Corporation, Belgium). The following parameters were assessed: changes in root canal volume and surface area, percentage of unshaped canal walls, structure model index, canal transportation and centering ratio. Data were analyzed using 2- and 3-way ANOVA with Tukey's and Scheffés post hoc tests (significance level of 5%).
RESULTS


No significant differences among groups were observed concerning all parameters. The type of curvature had no significant effect on all tested parameters. Within all experimental groups, canal transportation increased significantly from the apical to the coronal region, of which the majority was directed towards the furcational area.
CONCLUSIONS


Preparation with the three NiTi-systems did not result in significantly different dimensional changes and there was no significant effect of the type of curvature on all tested parameters.",2020,"CONCLUSIONS


Preparation with the three NiTi-systems did not result in significantly different dimensional changes and there was no significant effect of the type of curvature on all tested parameters.",['Seventy-five moderately curved mandibular molars with two separate mesial root canals'],[],"['root canal volume and surface area, percentage of unshaped canal walls, structure model index, canal transportation and centering ratio', 'canal transportation']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0447375', 'cui_str': 'Mesial tooth root'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]",[],"[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0565073,"CONCLUSIONS


Preparation with the three NiTi-systems did not result in significantly different dimensional changes and there was no significant effect of the type of curvature on all tested parameters.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Haupt', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany. Electronic address: franziska.haupt@med.uni-goettingen.de.'}, {'ForeName': 'Jonas Robert', 'Initials': 'JR', 'LastName': 'Wilhelm Pult', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hülsmann', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.005']
2689,32464142,"Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial.","BACKGROUND AND AIMS


Endoscopic assessment of mucosal appearance by independent central reading has become the standard method to assess Crohn's disease (CD) activity in clinical trials. Performance characteristics of various endoscopy reading models have yet to be systematically evaluated.
METHODS


This substudy included patients with CD in the exploratory induction cohort of BERGAMOT (NCT02394028) randomly assigned to etrolizumab or placebo. Endoscopies conducted at baseline and week 14 were independently scored using the Simple Endoscopic Score for Crohn's disease (SES-CD) by a local reader (LR) and 2 central readers (CRs). Five endoscopy reading models were compared: single LR, single CR, average of 2 CRs, and 2 models incorporating the LR and 1 to 2 CRs depending upon alignment between LR and CR, defined according to a sliding scale applied to a range of scores.
RESULTS


Five hundred thirty-five videos were scored. Models involving 2 readers demonstrated lower placebo rates (3.4%) than the single LR (11.9%) and the single CR (6.8%) models. Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 to 2 CRs (Δ = 16.2%). Further, in the etrolizumab arm, models with 2 readers demonstrated the lowest variability on the SES-CD.
CONCLUSIONS


Central endoscopy reading models in CD impact placebo response rates and effect size. Incorporating the local reader appears to be important as models using both central and local readers resulted in the greatest treatment effect size for endoscopic improvement with etrolizumab, lower placebo rates, and reduced variability.",2020,Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 to 2 CRs (Δ = 16.2%).,"['Five hundred thirty-five videos were scored', ""Crohn's disease"", 'patients with CD in the exploratory induction cohort of BERGAMOT (NCT02394028) randomly assigned to']","['etrolizumab or placebo', 'various central endoscopy reading models']","['placebo rates', 'endoscopic improvement']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",535.0,0.293146,Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 to 2 CRs (Δ = 16.2%).,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Medical University of Vienna, Vienna, Austria. Electronic address: walter.reinisch@meduniwien.ac.at.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Mishkin', 'Affiliation': 'Atrius Health, Boston, MA, USA.'}, {'ForeName': 'Young S', 'Initials': 'YS', 'LastName': 'Oh', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Fez', 'Initials': 'F', 'LastName': 'Hussain', 'Affiliation': 'Gastroenterology Center of Excellence, IQVIA, Reading, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daperno', 'Affiliation': 'Mauriziano Hospital, Turin, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.020']
2690,32464224,Higher or Usual Volume Feedings in Very Preterm Infants: A Randomized Clinical Trial.,"OBJECTIVE


To determine if higher volume feedings improve postnatal growth among very preterm infants.
STUDY DESIGN


Randomized clinical trial with 1:1 parallel allocation conducted from 1/2015 to 6/2018 in a single academic medical center in the United States. 224 infants with a birth weight 1001-2500 grams born at <32 weeks of gestation were randomized to higher (180-200 mL/kg/day) or usual volume feedings (140-160 mL/kg/day) after establishing full enteral feedings (≥120 mL/kg/day). The primary outcome was growth velocity (g/kg/day) from randomization to study completion at 36 weeks of postmenstrual age or hospital discharge if earlier.
RESULTS


Growth velocity increased among infants in the higher volume group compared with the usual volume group (mean [SD], 20.5 [4.5] versus 17.9 [4.5] g/kg/day; p<0.001). At study completion, all measurements were higher among infants in the higher volume group compared with the usual volume group; weight (2365 [324] g, Z-score -0.60 [0.73] versus 2200 [308] g, Z-score -0.94 [0.71]; p<0.001); head circumference (31.9 [1.3] cm, Z-score -0.30 [0.91] versus 31.4 [1.3] cm, Z-score -0.53 [0.84]; p=0.01); length (44.9 [2.1] cm, Z-score -0.68 [0.88] versus 44.4 [2.0], Z-score -0.83 [0.84]; p=0.04); and mid-arm circumference (8.8 [0.8] cm versus 8.4 [0.8] cm; p=0.002). Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
CONCLUSION(S)


In very preterm infants weighing 1001-2500 grams at birth, higher volume feedings increased growth velocity, weight, head circumference, length, and mid-arm circumference compared with usual volume feedings without adverse effects.",2020,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","['Very Preterm Infants', '224 infants with a birth weight 1001-2500 grams born at <32 weeks of gestation', 'very preterm infants', '1/2015 to 6/2018 in a single academic medical center in the United States']",['usual volume feedings'],"['growth velocity, weight, head circumference, length, and mid-arm circumference', 'Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis', 'growth velocity', 'head circumference', 'hospital discharge if earlier', 'Growth velocity']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",224.0,0.372561,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","[{'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States. Electronic address: ctravers@peds.uab.edu.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States; Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States; Division of Neonatology, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Dills', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States; Department of Surgery, Louisiana State University Health Sciences Center, New Orleans, LA, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Laney', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States; Division of Neonatology, Nemours Alfred I. duPont Hospital for Children, Wilmington, DE, United States.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Winter', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, United States.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.033']
2691,32464260,"Methylphenidate as needed for fatigue in patients with advanced cancer. A prospective, double-blind, placebo-controlled study.","CONTEXT


Cancer related fatigue is a highly prevalent symptom with a strong negative impact on patients' daily life.
OBJECTIVE


To evaluate the efficacy of methylphenidate as needed for the management of fatigue in patients with advanced cancer.
METHODS


A prospective, controlled, double-blind, paired design, where the patient was her/his own control. Patients with advanced cancer with a tiredness score > 50 on a 0-100 visual analogue scale (VAS) were included. Patients were given 10 placebo and 10 methylphenidate tablets numbered 1 to 20 packed in blocks of four with two active and two placebo tablets (randomly arranged). Patients taking minimum three tablets were regarded evaluable. Primary effect parameters were mean differences in VAS for tiredness after two and five hours. With 28 evaluable patients, the study had a power of 0.90 to detect a mean difference of 15 between active and placebo.
RESULTS


Thirty-eight patients were enrolled to get 28 evaluable patients. Mean tiredness score before taking the tablets was 75 for placebo and 72 for methylphenidate on VAS (0-100). Mean changes (decrease) for methylphenidate after two and five hours were 20 and 17, respectively, and 8 and 5 for placebo. Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
CONCLUSION


In this controlled, double-blind study in patients with advanced cancer, methylphenidate as needed was significantly more effective than placebo in relieving fatigue after two and five hours.",2020,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","['Thirty-eight patients were enrolled to get 28 evaluable patients', 'Patients with advanced cancer with a tiredness score > 50 on a 0-100 visual analogue scale (VAS) were included', 'patients with advanced cancer']","['methylphenidate tablets', 'methylphenidate', 'Methylphenidate', 'placebo tablets', 'placebo']","['Mean tiredness score', 'relieving fatigue', 'VAS for tiredness']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.380608,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: line.lund.01@regionh.dk.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten Aa', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjogren', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Section of Palliative Medicine, Department of Oncology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Section of Health Services Research, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.05.023']
2692,32464264,Consolidation of use-dependent motor memories induced by passive movement training.,"Motor adaptation, a type of motor learning, is often thought to involve two distinct processes: error-based and use-dependent learning. Passive movement training, which is associated with use-dependent learning, can facilitate motor adaptation, although it is unknown how long its facilitative effect can last. The objective of this study was to examine the lasting effect of passive training on visuomotor adaptation for the duration of up to 24 hours. Neurotypical, right-handed subjects experienced four experimental sessions: baseline, training, time delay and testing. In the training session, all subjects received passive training of their dominant arm that was moved by an exoskeletal robot in a ""desired"" target direction repeatedly. Following that, the subjects experienced a time delay of 5 minutes, 1 hour or 24 hours. In the testing session, the subjects performed reaching movements under a novel visuomotor condition, in which the visual display was rotated 30 degrees counterclockwise about the start circle. Control subjects experienced the baseline and testing sessions with a time delay of 5 minutes between the two sessions. Results indicate that the 1 -h and 24 -h groups, but not the 5-minute group, adapted to the rotation significantly better than the controls. This finding has an implication for neurorehabilitation suggesting, for example, that passive proprioceptive training may indeed be a viable option for improving arm motor function in stroke survivors with severe hemiparesis, for whom efficient intervention techniques are very limited.",2020,"Results indicate that the 1 -h and 24 -h groups, but not the 5-minute group, adapted to the rotation significantly better than the controls.",['stroke survivors with severe hemiparesis'],"['passive training', 'passive movement training', 'passive training of their dominant arm that was moved by an exoskeletal robot', 'Passive movement training']",['visuomotor adaptation'],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0336537', 'cui_str': 'Robot'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.0132174,"Results indicate that the 1 -h and 24 -h groups, but not the 5-minute group, adapted to the rotation significantly better than the controls.","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Tays', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, United States.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, United States.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Javidialsaadi', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, United States.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, United States. Electronic address: wang34@uwm.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135080']
2693,32455843,Short-Term Effects of Comprehensive Pulmonary Rehabilitation and its Maintenance in Patients with Idiopathic Pulmonary Fibrosis: A Randomized Controlled Trial.,"The recommendation for pulmonary rehabilitation (PR) in idiopathic pulmonary fibrosis (IPF) is weak with low-quality evidence. Therefore, the aim of this study is to investigate short-term PR effects and their maintenance after a 3-month follow-up. Fifty-four IPF patients were randomized into a group receiving a 3-week comprehensive, inpatient PR ( n  = 34, FVC: 74 ± 19% pred.) or usual care (UC) ( n  = 17, FVC: 72 ± 20%pred.). Outcomes were measured at baseline (T1), after intervention (T2), and 3 months after T2 (T3). A 6-min walk distance (6MWD) was used as the primary outcome and chronic respiratory disease questionnaire (CRQ) scores as the secondary outcome. Change in 6MWD from T1 to T2 (Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups. Higher baseline FVC and higher anxiety symptoms were significant predictors of better short-term 6MWD improvements. For the change in CRQ total score, a significant between-group difference from T1 to T2 (∆ = 3.0 pts, 95% CI (0.7-5.3),  p  = 0.01) and from T1 to T3 (∆ = 3.5 pts, 95% CI (1.5-5.4),  p  = 0.001) was found in favour of the PR group. To conclude, in addition to the short-term benefits, inpatient PR is effective at inducing medium-term quality of life improvements in IPF. PR in the early stages of the disease seems to provoke the best benefits.",2020,"(Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups.","['idiopathic pulmonary fibrosis (IPF', 'Fifty-four IPF patients', 'Patients with Idiopathic Pulmonary Fibrosis']","['Comprehensive Pulmonary Rehabilitation', 'usual care (UC', 'pulmonary rehabilitation (PR']","['anxiety symptoms', 'CRQ total score', 'A 6-min walk distance (6MWD', 'chronic respiratory disease questionnaire (CRQ) scores']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C3164099', 'cui_str': 'Chronic respiratory disease questionnaire score'}]",54.0,0.058295,"(Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Gloeckl', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Germany and German Center for Lung Research, Röntgenstr. 1, 69126 Heidelberg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Frankenberger', 'Affiliation': 'Comprehensive Pneumology Center (CPC), Ludwig-Maximilians University, Helmholtz Zentrum München, Member of the German Center for Lung Research (DZL), 81377 Munich, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Neurohr', 'Affiliation': 'Pneumology and Thoracic Oncology, Robert-Bosch Krankenhaus, Klinik Schillerhoehe, 70839 Gerlingen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Prasse', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School and Biomedical Research in End-Stage and Obstructive Lung Disease Hannover, German Lung Research Center (DZL), 30625 Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Freise', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School and Biomedical Research in End-Stage and Obstructive Lung Disease Hannover, German Lung Research Center (DZL), 30625 Hannover, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Behr', 'Affiliation': 'Department of Internal Medicine V and Asklepios Fachkliniken München-Gauting, Comprehensive Pneumology Center (CPC-M), Member of the German Center for Lung Research, University of Munich, LMU, 82131 Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, 5020 Salzburg, Austria.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051567']
2694,32455853,Low-Intensity Physical Exercise Improves Pain Catastrophizing and Other Psychological and Physical Aspects in Women with Fibromyalgia: A Randomized Controlled Trial.,"Fibromyalgia (FM) is a chronic syndrome characterized by widespread pain and other physical and psychological features. In this study, we aimed to analyze the effect of a low-intensity physical exercise (PE) program, combining endurance training and coordination, on psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity) in women with FM. For this purpose, a randomized controlled trial was carried out. Thirty-two women with FM were randomly allocated to a PE group (PEG, n = 16), performing an eight-week low-intensity PE program and a control group (CG, n = 16). Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity were assessed before and after the intervention. We observed a significant improvement in all studied variables in the PEG after the intervention ( p  < 0.05). In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05). In conclusion, a low-intensity combined PE program, including endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning in women with FM.",2020,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05).","['Women with Fibromyalgia', 'Thirty-two women with FM', 'women with FM']","['low-intensity physical exercise (PE) program, combining endurance training and coordination', 'Low-Intensity Physical Exercise', 'PE group (PEG, n = 16), performing an eight-week low-intensity PE program']","['psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity', 'Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity', 'endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",32.0,0.0914066,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Izquierdo-Alventosa', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Freshage Research Group, Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cortés-Amador', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Gimeno-Mallench', 'Affiliation': 'Freshage Research Group, Department of Physiology, Faculty of Medicine, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Chirivella-Garrido', 'Affiliation': 'Fundación Fivan, Centro de Neurorehabilitación, 46005 Valencia, Spain.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Kropotov', 'Affiliation': 'N.P. Bechtereva Institute of Human Brain, Russian Academy of Science, 197022 St. Petersburg, Russia.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103634']
2695,32455857,The Effects of Lateral Bounds on Post-Activation Potentiation of Change-of-Direction Speed Measured by the 505 Test in College-Aged Men and Women.,"Forty recreationally-trained individuals completed four testing sessions to determine whether lateral bounds (LB) or weighted lateral bounds enhanced change-of-direction (COD) speed measured by the 505 COD speed test. Session 1 included vertical jump and lateral bound (LB) testing to measure power. Sessions 2-4 involved three randomized conditioning activities (CA): 3 × 5 LB; 3 × 5 weighted LB (10% body mass provided by a weighted vest); and a control condition (4-min rest). The 505 COD speed test was performed 5- and 2.5-min pre-CA, and ~15 s, 4, 8, 12, and 16 min post-CA. A 3 × 6 repeated measures analysis of variance (ANOVA) calculated performance changes across time points post-CA. A 3 × 2 repeated measures ANOVA analyzed best potentiated performance. Smallest worthwhile change (SWC) measured within-subject 505 COD speed test performance. Partial correlations controlling for sex calculated relationships between the vertical jump, LB, and percent potentiation. There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded. The best potentiated 505 time was faster ( p  < 0.001) than baseline for all CA, with no between-CA differences. There were no significant ( p  = 0.056-0.993) correlations between power and potentiation. LB and weighted LB did not potentiate the 505 COD speed test, although performance was not hindered.",2020,"There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded.","['College-Aged Men and Women', 'Forty recreationally-trained individuals']",['lateral bounds (LB) or weighted lateral bounds enhanced change-of-direction (COD) speed measured by the 505 COD speed test'],"['vertical jump and lateral bound (LB) testing to measure power', 'Smallest worthwhile change (SWC']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449250', 'cui_str': 'Speed of test'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0225115,"There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded.","[{'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Orjalo', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Balfany', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Callaghan', 'Affiliation': 'Centre for Sports and Exercise Science Research, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA 6027, Australia.'}]","Sports (Basel, Switzerland)",['10.3390/sports8050071']
2696,32456097,Effects of a Rehabilitation Programme with a Nasal Inspiratory Restriction Device on Exercise Capacity and Quality of Life in COPD.,"OBJECTIVE


The objective was to assess the effects of a nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP) on exercise capacity, quality of life, dyspnea and inspiratory muscle strength in patients with stable COPD.
METHODS


Patients were randomized into three groups, one performed a supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). We evaluated inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT) before and after 8-week of RP.
RESULTS


A total of 16 patients completed the study, seven in FB group, five in ONB group and four in the CG. After the RP, the FB group showed a significant increase in P Imax  (93.3 ± 19.1 vs. 123.0 ± 15.8 mmHg) and in the 6MWT distance (462.9 ± 71.8m vs. 529.1 ± 50.1 m) and a decrease in the CAT score (9.7 ± 6.5 vs. 5.9 ± 6.0) and in the mMRC dyspnea score. FB provides greater improvement in P Imax , dyspnea, quality of life and 6MWT than ONB.
CONCLUSIONS


The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.",2020,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","['16 patients completed the study, seven in FB group, five in ONB group and four in the CG', 'patients with stable COPD', 'Patients']","['nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP', 'Rehabilitation Programme with a Nasal Inspiratory Restriction Device', 'supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG']","['CAT score', 'P Imax , dyspnea, quality of life and 6MWT', 'quality of life, dyspnea, exercise capacity and inspiratory muscle strength', 'Exercise Capacity and Quality of Life in COPD', 'mMRC dyspnea score', 'exercise capacity, quality of life, dyspnea and inspiratory muscle strength', 'P Imax', 'inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",16.0,0.0239412,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'España-Domínguez', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, Puerta del Mar University Hospital University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cuenca-García', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103669']
2697,32456130,Comparison of Chest Compression Quality Using Wing Boards versus Walking Next to a Moving Stretcher: A Randomized Crossover Simulation Study.,"BACKGROUND


When a rescuer walks alongside a stretcher and compresses the patient's chest, the rescuer produces low-quality chest compressions. We hypothesized that a stretcher equipped with wing boards allows for better chest compressions than the conventional method.
METHODS


In this prospective, randomized, crossover study, we enrolled 45 medical workers and students. They performed hands-on chest compressions to a mannequin on a moving stretcher, while either walking (the walk method) or riding on wings attached to the stretcher (the wing method). The depths of the chest compressions were recorded. The participants' vital signs were measured before and after the trials.
RESULTS


The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01). The average compression rates during the two minutes were 215 ± 8 and 217 ± 5 compressions in the walk and wing methods, respectively ( p  = ns). Changes in blood pressure (14 ± 11 vs. 22 ± 14 mmHg), heart rate (32 ± 13 vs. 58 ± 20 bpm), and modified Borg scale (4 (interquartile range: 2-4) vs. 6 (5-7)) were significantly lower in the wing method cohort compared to the walking cohort ( p  < 0.01). The rescuer's size and physique were positively correlated with the chest compression depth during the walk method; however, we found no significant correlation in the wing method.
CONCLUSIONS


Chest compressions performed on the stretcher while moving using the wing method can produce high-quality chest compressions, especially for rescuers with a smaller size and physique.",2020,The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01).,['enrolled 45 medical workers and students'],['Chest Compression Quality Using Wing Boards versus Walking Next to a Moving Stretcher'],"['chest compression depth', 'blood pressure', 'average compression depth', 'average compression rates', 'heart rate']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",45.0,0.0202947,The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01).,"[{'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Takeji', 'Initials': 'T', 'LastName': 'Saitoh', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Department of Cardiology, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Atsuto', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051584']
2698,32456170,Acute Effects of a Short Bout of Physical Activity on Cognitive Function in Sport Students.,"Physical activity is a promising intervention to restore cognitive function after prolonged sedentary periods. However, little is known about the effect of short physical activity bouts on cognition especially among individuals that are used to physical activity. Therefore, the goal of the present study was to assess the impact of a single ten-minute physical activity bout on the cognitive domain of visual attention compared to sedentary behavior in a population of physically active sport students. Using a randomized controlled design, 51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female] were allocated to one of the following interventions in the break of a two-hour study course: physical activity group (running for ten minutes) and sedentary control group. Visual attention was measured post-intervention using a modified trail making test. Pre-, post-, and 30 min after intervention, perceived attention, and affective states were measured. Between-group comparisons were used to analyze whether visual attention and/or changes in perceived attention or affective states differed between groups. The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  p  = 0.003,  d  = 0.89. Perceived attention,  p  = 0.006,  d  = 0.87, and arousal,  p  < 0.001,  d  = 1.68, showed a significantly larger pre- and post-intervention increase in the physical activity group compared with the sedentary control group, which was not evident 30 min after intervention. A single ten-minute running intervention in study breaks might help to restore the basal visual attentional domain of cognition after prolonged sedentary periods more effectively compared with common sedentary behavior in breaks between study lessons.",2020,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  ","['population of physically active sport students', 'Sport Students', '51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female']","['physical activity group (running for ten minutes) and sedentary control group', 'Short Bout of Physical Activity']","['visual attention and/or changes in perceived attention or affective states', 'basal visual attentional domain of cognition', 'visual attention', 'perceived attention, and affective states', 'Cognitive Function', 'Visual attention']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",51.0,0.061781,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steidl-Müller', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17103678']
2699,32456180,"Effectiveness of the ""Mente Sana [Healthy Mind]"" Cognitive Training Program for Older Illiterate Adults with Mild Cognitive Impairment.","Aging can lead to functional and cognitive alterations, sometimes limiting older adults in their social development, especially illiterate groups of older adults who receive poor attention from healthcare systems. In this context, the present investigation proposes the cognitive training program ""MENTE SANA [HEALTHY MIND]"" to improve the cognitive functions of illiterate older adults in Arequipa (Peru). It is a type of quasi-experimental research with a pre-test/post-test design with a homogenous control group. The sample was made up of adults 60 years old and above and of female gender. The Montreal Cognitive Assessment (MoCA) test was used to detect the level of cognitive decline in illiterate older adults. The 50-sessions program was applied to all the older adults with mild cognitive impairment that were selected for the study, on a daily basis. It was found that the tested group improved their cognitive functions compared to the control group. These results help to propose adapted cognitive training programs for illiterate people.",2020,It was found that the tested group improved their cognitive functions compared to the control group.,"['illiterate older adults', 'older adults with mild cognitive impairment', 'illiterate older adults in Arequipa (Peru', 'adults 60 years old and above and of female gender', 'older adults in their social development, especially illiterate groups of older adults who receive poor attention from healthcare systems', 'Older Illiterate Adults with Mild Cognitive Impairment']","['Mente Sana [Healthy Mind', 'Cognitive Training Program']","['cognitive functions', 'Montreal Cognitive Assessment (MoCA) test']","[{'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0075451', 'cui_str': 'succinyl-trialanine-4-nitroanilide'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0106571,It was found that the tested group improved their cognitive functions compared to the control group.,"[{'ForeName': 'Yaneth Del Rosario', 'Initials': 'YDR', 'LastName': 'Palo Villegas', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'Andrea Elena', 'Initials': 'AE', 'LastName': 'Pomareda Vera', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Rojas Zegarra', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'M Dolores', 'Initials': 'MD', 'LastName': 'Calero', 'Affiliation': 'Mind, Brain, and Behavior Research Center, University of Granada, Avenida del Hospicio, CP: 18071 Granada, Spain.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5020034']
2700,32456230,The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial.,"Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group ( n  = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group ( n  = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35,  p  < 0.001, median nerve; +1.60 m/s, IQR 1.80,  p  < 0.001, sural nerve; +0.75 m/s, IQR 2.25,  p  < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.",2020,Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation.,"['Diabetic Neuropathy', '80 eligible participants', 'diabetic patients']","['Tocovid supplementation', 'Tocotrienol-Rich Vitamin E (Tocovid', 'Tocovid', 'placebo']","['serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2', 'nerve conduction velocities', 'nerve conduction parameters', 'levels of serum NGF']","[{'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4742400', 'cui_str': 'Tocovid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0027788', 'cui_str': 'Nerve conduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.207012,Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation.,"[{'ForeName': 'Yeek Tat', 'Initials': 'YT', 'LastName': 'Ng', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Sonia Chew Wen', 'Initials': 'SCW', 'LastName': 'Phang', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Gerald Chen Jie', 'Initials': 'GCJ', 'LastName': 'Tan', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'En Yng', 'Initials': 'EY', 'LastName': 'Ng', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Nevein Philip', 'Initials': 'NP', 'LastName': 'Botross Henien', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Uma Devi', 'Initials': 'UD', 'LastName': 'M Palanisamy', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Badariah', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abdul Kadir', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}]",Nutrients,['10.3390/nu12051522']
2701,32456236,"A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial.","PURPOSE


Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness.  Methods : We randomized children aged 1-12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores.  Results : In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98). PedQL fatigue scores for sleep ( p  = 0.032) and total fatigue scores ( p  = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI.  Conclusion : The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children's well-being can be improved without medication.",2020,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","['children and adults', '62 children were included', 'children aged 1-12 years with SH to the control group (standard care = no treatment) or', 'Children with Subclinical Hypothyroidism']","['dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months', 'A Lifestyle (Dietary) Intervention', 'thyroxine supplementation', 'intervention group (dietary intervention', 'lifestyle (dietary) intervention']","['Tiredness', 'Thyroid Stimulating Hormone (TSH) and/or tiredness', 'TSH', 'PedQL fatigue scores for sleep', 'normalize SH and TSH levels', 'lipid profile or BMI', 'total fatigue scores', 'tiredness', 'TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",62.0,0.037638,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Faculty of Behavioural, Management and Social Sciences (BMS), University of Twente, 7522 NB Enschede, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Schaap', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Mirthe', 'Initials': 'M', 'LastName': 'van Voorthuizen', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Department of Pediatrics, Medical Centre Twente, 7512 KZ Enschede, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17103689']
2702,32456250,Effects of the Use of Air Purifier on Indoor Environment and Respiratory System among Healthy Adults.,"Air purifiers have become popular among ordinary families. However, it remains controversial whether indoor air purification improves the respiratory health of healthy adults. A randomized crossover intervention study was conducted with 32 healthy individuals. The subjects were categorized into two groups. One group continuously used true air purifiers, and the other followed with sham air purifiers for 4 weeks. Following this first intervention, all the subjects underwent a 4-week washout period and continued with the second 4-week intervention with the alternate air purifiers. We collected fine particulate matter (PM) ≤ 2.5 µm in aerodynamic diameter (PM2.5), coarse particulate matter between 2.5 and 10 µm in aerodynamic diameter (PM10-2.5) and ozone (O 3 ). The subjects' pulmonary function and fractional exhaled nitric oxide (FeNO) were measured during the study period. The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers. However, this decrease was not significant ( p  = 0.08). The air purification did not significantly improve the pulmonary function of the study subjects. In contrast, an increase in the indoor PM10-2.5 and O 3  concentration led to a significant decrease in the forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF), respectively. In conclusion, air purification slightly improved the indoor PM2.5 concentrations in ordinary homes but had no demonstrable impact on improving health.",2020,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"['Healthy Adults', 'healthy adults', '32 healthy individuals']",['Air Purifier'],"['health', 'indoor PM2.5 concentrations', 'pulmonary function', 'Indoor Environment and Respiratory System', ""subjects' pulmonary function and fractional exhaled nitric oxide (FeNO"", 'forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0262774', 'cui_str': 'Air Purifier'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231985', 'cui_str': 'Mean maximum expiratory flow'}]",32.0,0.016093,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Yoda', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': ""Hyogo Regional Center of Japan Environment and Children's Study, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.""}, {'ForeName': 'Naruhito', 'Initials': 'N', 'LastName': 'Otani', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Shoji F', 'Initials': 'SF', 'LastName': 'Nakayama', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shima', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103687']
2703,32456272,Optimizing the Interaction of Exercise Volume and Metformin to Induce a Clinically Significant Reduction in Metabolic Syndrome Severity: A Randomised Trial.,"Insulin resistance is a central mediating factor of the metabolic syndrome (MetS), with exercise training and metformin proven antidotes to insulin resistance. However, when the two therapies are combined there is conflicting data regarding whether metformin blunts or improves exercise training-induced adaptations. The volume of exercise (duration, intensity, and frequency) on the interaction of exercise training and metformin has yet to be investigated. The aim of this study is therefore to explore the impact of a combination of different exercise volumes and metformin on MetS severity. This is a secondary analysis of data from one of the sites of the 'Exercise in Prevention of Metabolic Syndrome' (EX-MET) study. Ninety-nine adults with MetS were randomized into a 16-week exercise program completing either: (i) moderate-intensity continuous training (MICT) at 60-70% of peak heart rate (HRpeak) for 30 min/session ( n  = 34, 150 min/week); (ii) high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak ( n  = 34, 38 min/session, 114 min/week); or (iii) low volume HIIT, 1 × 4 min bout of HIIT at 85-95% HRpeak ( n  = 31, 17 min/session, 51 min/week). Metformin intake was monitored and recorded throughout the trial. MetS severity was calculated as z-scores derived from MetS risk factors assessed at pre- and post-intervention. Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking metformin. Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75). While there were no between-group differences ( p  = 0.24), in those who did not take metformin low-volume HIIT had more likely responders (10/15, 67%) compared to MICT (6/16, 38%) and high-volume HIIT (7/16, 44%). In those taking metformin, there was a lower proportion of participants who clinically improved MetS severity following high-volume HIIT (1/6, 17%) compared to MICT (2/4, 50%) and low-volume HIIT (5/8, 63%), but with no between-group difference ( p  = 0.23). Moreover, in those who performed high-volume HIIT, there was a statistically significantly higher proportion ( p  = 0.03) of likely non-responders with improved MetS severity in participants taking metformin (4/6, 67%) compared to those not taking metformin (3/16, 19%). In individuals with MetS, the effect of high volume HIIT on MetS severity may be blunted in those taking metformin. These findings need to be confirmed in a larger study.",2020,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","['Ninety-nine adults with MetS', 'Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking']","['exercise training and metformin', 'Metformin', 'metformin', 'exercise program completing either: (i) moderate-intensity continuous training (MICT', 'MICT', 'high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak']","['MetS severity', 'volume of exercise (duration, intensity, and frequency']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",99.0,0.0481252,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","[{'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Ramos', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Lance C', 'Initials': 'LC', 'LastName': 'Dalleck', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Keith', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Fennell', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Lee', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Fassett', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103695']
2704,32456525,Effectiveness and Safety of Novel Nutraceutical Formulation Added to Ezetimibe in Statin-Intolerant Hypercholesterolemic Subjects with Moderate-to-High Cardiovascular Risk.,"The effectiveness of statins in the primary and secondary prevention of cardiovascular (CV) diseases has been widely proven. However, the onset of adverse events associated with their use prevents to achieve the therapeutic targets recommended by the guidelines (GL) for the management of dyslipidemia. In the event of statin intolerance, the GL recommend to use bile acid sequestrants, fibrates, and ezetimibe in monotherapy, but their benefits in improving lipid pattern are quite modest. This study aims at evaluating the effectiveness and safety of a nutraceutical compound (NC) associated with ezetimibe (EZE) on the lipid profile in statin-intolerant patients with moderate-to-high CV risk. Ninety-six statin-intolerant hypertensive and hypercholesterolemic subjects treated pharmacologically with EZE 10 mg daily were randomized in open label ( n  = 48) to take for 3 months a NC containing Monacolin-K (MK), Berberine Hydrochloride (BC), t-Resveratrol (RES), Quercetin (QUER), and Chromium (CH) in the form of a gastro-resistant tablet that improves enteric bioaccessibility and bioavailability of these substances. The control group ( n  = 48) took only EZE in monotherapy at the same dosage; both groups followed a standardized lipid-lowering diet. The total serum cholesterol (TC), low density lipoprotein cholesterol (LDLC), high density lipoprotein cholesterol (HDLC), triglycerides (TG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine phosphokinase (CPK) levels were compared at the follow-up in both groups using Student's  t -test. TC and LDL levels reduced in both groups, but were lower in the group treated with EZE + NC (-25.9% vs. -15%,  P  < .05 and -38.7% vs. -21.0%,  P  < .05, respectively). No changes were observed in either group regarding a decrease in TG (-9.4% vs. -11.7%, NS) and an increase in HDLC (+4.2% vs. +1.1%, NS). The AST, ALT, and CPK levels increased in the group treated with the EZE + NC compared to the control group, but were still within the acceptable range. There was no difference concerning the lipid-lowering treatment between gender, and no patient withdrew from the study. In the short term, the EZE + NC combination therapy is well tolerated and effective in improving TC and LDLC levels in statin-intolerant patients with moderate-to-high CV risk.",2020,"In the short term, the EZE + NC combination therapy is well tolerated and effective in improving TC and LDLC levels in statin-intolerant patients with moderate-to-high CV risk.","['Statin-Intolerant Hypercholesterolemic Subjects with Moderate-to-High Cardiovascular Risk', 'Ninety-six statin-intolerant hypertensive and hypercholesterolemic subjects treated pharmacologically with', 'statin-intolerant patients with moderate-to-high CV risk']","['standardized lipid-lowering diet', 'ezetimibe (EZE', 'Ezetimibe', 'EZE + NC combination therapy', 'EZE + NC', 'EZE in monotherapy', 'nutraceutical compound (NC', 'EZE 10\u2009mg daily were randomized in open label ( n \u2009=\u200948) to take for 3 months a NC containing Monacolin-K (MK), Berberine Hydrochloride (BC), t-Resveratrol (RES), Quercetin (QUER), and Chromium (CH']","['AST, ALT, and CPK levels', 'HDLC', 'TG', 'total serum cholesterol (TC), low density lipoprotein cholesterol (LDLC), high density lipoprotein cholesterol (HDLC), triglycerides (TG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine phosphokinase (CPK) levels', 'tolerated and effective in improving TC and LDLC levels', 'TC and LDL levels', 'lipid profile']","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0873019', 'cui_str': 'Berberine hydrochloride'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.0215493,"In the short term, the EZE + NC combination therapy is well tolerated and effective in improving TC and LDLC levels in statin-intolerant patients with moderate-to-high CV risk.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mazza', 'Affiliation': 'ESH Excellence Hypertension Centre, Internal Medicine Unit, Santa Maria della Misericordia General Hospital, Rovigo, Italy.'}, {'ForeName': 'Mariaceleste', 'Initials': 'M', 'LastName': 'Nicoletti', 'Affiliation': 'Krea Innovazione srl, Milano, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lenti', 'Affiliation': 'Hypertension Centre and Internal Medicine and Geriatrics, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Torin', 'Affiliation': 'Internal Medicine Unit, Department of Medicine, Santa Maria della Misericordia General Hospital, Rovigo, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Rigatelli', 'Affiliation': 'Interventional Cardiology Unit, Division of Cardiology, S. Maria della Misericordia General Hospital, Rovigo, Italy.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Pellizzato', 'Affiliation': 'Italian Society of Nutraceutical Formulators (SIFNUT), Treviso, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fratter', 'Affiliation': 'Italian Society of Nutraceutical Formulators (SIFNUT), Treviso, Italy.'}]",Journal of medicinal food,['10.1089/jmf.2020.0019']
2705,32456572,"Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects.","We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects. Methods:  Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women (35.2 ± 11.4 years, 28.5 ± 3.3 kg/m 2 ) ingested either Hemp Oil Extract [Hemp, 60 mg/d PlusCBD TM  Extra Strength Hemp Extract Oil (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks while continuing to follow their normal diet and physical activity patterns. Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health. Data were analyzed using mixed factorial ANOVA, t-tests with 95% confidence intervals, and effect sizes (ES). Results : HDL cholesterol significantly improved in the Hemp group ( p  = 0.004; ES = 0.75). No other statistically significant group x time interaction effects were observed. Statistical tendencies for between-group differences were found for 'I Get Pleasure From Life' ( p  = 0.06, ES = 0.48) and 'Ability to Cope with Stress' ( p  = 0.07, ES = 0.46). Sleep quality (Hemp,  p  = 0.005, ES = 0.54) and sleep quantity (Hemp,  p  = 0.01, ES = 0.58) exhibited significant within-group changes. All values for hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts remained within normal clinical limits with no between-group differences over time being identified. Conclusions : Hemp supplementation improved HDL cholesterol, tended to support psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns. Registered at clinicaltrials.gov: NCT04294706.",2020,"Statistical tendencies for between-group differences were found for 'I Get Pleasure From Life' ( p  = 0.06, ES = 0.48) and 'Ability to Cope with Stress' ( p  = 0.07, ES = 0.46).","['Overweight, But Otherwise Healthy Subjects', '65 overweight, but otherwise healthy men and women (35.2\u2009±\u200911.4\u2009years, 28.5\u2009±\u20093.3\u2009kg/m 2 ) ingested either', 'healthy human subjects']","['PlusCBD TM', 'Hemp Oil Extract [Hemp, 60\u2009mg', 'Extra Strength Hemp Extract Oil', 'placebo (PLA', 'Hemp Extract', 'placebo']","['I Get Pleasure From Life', 'sleep quantity', 'hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts', 'support psychometric measures of perceived sleep, stress response, and perceived life pleasure', 'changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health', 'stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers', 'Sleep quality', 'HDL cholesterol', 'Statistical tendencies', 'time interaction effects', 'Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0162335', 'cui_str': 'HEMP'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0430045', 'cui_str': 'Fasting blood lipids'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",65.0,0.133056,"Statistical tendencies for between-group differences were found for 'I Get Pleasure From Life' ( p  = 0.06, ES = 0.48) and 'Ability to Cope with Stress' ( p  = 0.07, ES = 0.46).","[{'ForeName': 'Hector L', 'Initials': 'HL', 'LastName': 'Lopez', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}, {'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Cesareo', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Raub', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Kedia', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Sandrock', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Kerksick', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, St. Charles, MO, USA.'}, {'ForeName': 'Tim N', 'Initials': 'TN', 'LastName': 'Ziegenfuss', 'Affiliation': 'The Center for Applied Health Sciences, Stow, OH, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1765941']
2706,32456614,Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study.,"BACKGROUND


Infertility is defined as the inability to conceive after 12 months of unprotected intercourse. It affects approximately one in six couples seeking pregnancy in France or western countries. Many lifestyle factors of the couples' pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, physical activity, stress, sleep…) have been identified as risk factors for infertility in both males and females. The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome. Nevertheless, adoption of a healthy lifestyle may improve fertility but lifestyle changes are difficult to achieve and to maintain due notably to behavioral factors.
METHODS


Consequently, we decided to propose an interventional study aimed at improving the quality of life of infertile couples before the start of assisted reproductive technology treatment. It is a randomized controlled multicentre trial. Both members of the couples are involved in an integrated global care program (PEPCI for ""Parcours Environnement PériConceptionnel en Infertilité"") vs. usual care. This global intervention not only considers diet and/or physical activity but follows a holistic approach, including a multidisciplinary assessment to address complete physical, psychological and social well-being. According to patient needs, this includes interventions on weight, exercise, diet, alcohol and drugs, mental and social health.
DISCUSSION


The main objective of trial is to demonstrate that periconceptional multidisciplinary care has a positive impact on reproductive functions. We will also focus on feasibility, acceptance, compliance and conditions of success of a multifaceted lifestyle intervention.
TRIAL REGISTRATION


The trial was registered at ClinicalTrials.gov, Identifier: NCT02961907 on November 11, 2016.",2020,The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome.,['infertile couples'],['therapeutic multiple-lifestyle intervention'],['quality of life'],"[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6.0,0.0616562,The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': 'Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France. charlotte.dupont@aphp.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Aegerter', 'Affiliation': 'Unité de Recherche Clinique et Département de Santé Publique, Assistance Publique - Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne, France.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Université Sorbonne Paris Nord, Laboratoire Educations et Pratiques de Santé, LEPS, UR 3412, F-93017, Bobigny, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Reyre', 'Affiliation': 'Department of Addiction Medicine and Psychiatry, APHP Avicenne University Hospital, Bobigny, France.'}, {'ForeName': 'François J', 'Initials': 'FJ', 'LastName': 'Lhuissier', 'Affiliation': 'Université Sorbonne Paris Nord, UMR INSERM 1272 Hypoxie et poumon, Bobigny, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bourgain', 'Affiliation': 'Department of Addiction Medicine and Psychiatry, APHP Avicenne University Hospital, Bobigny, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chabbert-Buffet', 'Affiliation': 'Service de Gynécologie-Obstétrique et Médecine de La Reproduction, APHP Hôpital Tenon, 4 Rue de La Chine, 75020, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cédrin-Durnerin', 'Affiliation': 'APHP Hôpital Jean verdier Service de médecine de la reproduction et préservation de la fertilité, avenue du 14-Juillet, 93143, Bondy, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Selleret', 'Affiliation': 'Service de Gynécologie-Obstétrique et Médecine de La Reproduction, APHP Hôpital Tenon, 4 Rue de La Chine, 75020, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Cosson', 'Affiliation': 'Paris 13 University, Sorbonne Paris Cité, Assistance Publique - Hôpitaux de Paris, Avicenne Hospital, Department of Endocrinology-Diabetology-Nutrition, CRNH-IdF, CINFO, Bobigny, France.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lévy', 'Affiliation': 'Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-2855-9']
2707,32456617,"DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis: a single-center, randomized, double-blind, placebo-controlled study.","BACKGROUND


DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis.
METHODS


In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200 mg or 20 mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively.
RESULTS


48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5% ± 11.4% vs. 85.8% ± 12.5%, p = 0.000), whereas no change was found in placebo group (86.9% ± 11.6% vs. 87.8% ± 11.7%, p = 0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2 = 5.247, OR = 3.31, p = 0.022).
CONCLUSIONS


NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered (http://www.chictr.org.cn/index.aspx).",2020,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","['patients with carotid artery atherosclerotic stenosis', '2019', 'patients with large cerebral atherosclerotic stenosis', '48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis', '120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA']","['NBP or placebo', 'placebo', 'DL-3-n-butylphthalide', 'Single photon emission computed tomography (SPECT', 'DL-3-n-butylphthalide (NBP', 'NBP']","['CBF amelioration in ipsilateral MCA', 'ROIs with rCBF amelioration and stabilization', 'rCBF in ROIs', 'regional CBF (rCBF', 'cerebral blood flow (CBF', 'cerebral hypoperfusion', 'rCBF change for every ROI and the whole CBF change in MCA territory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}]",120.0,0.605911,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China. shijin_dr9@126.com.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Faguo', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""PET Center, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}]",BMC neurology,['10.1186/s12883-020-01801-5']
2708,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES


The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS


Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS


Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS


Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, VanNuys Med Sci Building, Suite, 224 635, Indiana, USA; University School of Medicine, Indianapolis, IN, 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 USF Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Obstetrics, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalo_perez@merck.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
2709,31279306,Development and validation of a prognostic nomogram for overall survival in patients with platinum-resistant ovarian cancer treated with chemotherapy.,"BACKGROUND


Platinum-resistant ovarian cancer (PROC) is associated with a variable prognosis and unpredictable survival times. We have developed and validated a prognostic nomogram with the objective of improving the prediction of overall survival (OS) in patients treated with chemotherapy.
METHODS


The nomogram was developed using data from a training cohort of patients from two trials, including the chemotherapy-only arm in AURELIA and all randomised patients in CARTAXHY. Multivariable proportional hazards models were generated based on pretreatment characteristics to develop a nomogram that classifies patients based on OS. We subsequently assessed the performance of the nomogram in terms of discrimination and calibration in independent validation patient cohorts: PENELOPE and the bevacizumab-chemotherapy arm of AURELIA.
RESULTS


The nomogram included six significant OS predictors, in order of importance: performance status, ascites, size of the largest tumour, CA-125, platinum-free interval and primary platinum resistance (C-statistic 0.69). In the training cohort, the median OS in the good, intermediate and poor prognosis groups was 25.3, 15.2 and 7.4 months, respectively. In the PENELOPE validation cohort (C-statistic 0.59), the median OS in the good, intermediate and poor prognosis groups was 18.5, 10.3 and 5.8 months, respectively. In the AURELIA bevacizumab-chemotherapy validation cohort (C-statistic 0.67), the median OS in good, intermediate and poor prognosis groups was 26.7, 13.8 and 10.0 months, respectively.
CONCLUSIONS


This nomogram with six pretreatment characteristics allows prediction of OS in PROC and could be used for stratification of patients in clinical trials as well as for counselling patients about prognosis.",2019,"In the PENELOPE validation cohort (C-statistic 0.59), the median OS in the good, intermediate and poor prognosis groups was 18.5, 10.3 and 5.8 months, respectively.","['patients with platinum-resistant ovarian cancer treated with', 'patients treated with chemotherapy']","['chemotherapy', 'bevacizumab-chemotherapy']","['median OS', 'overall survival (OS', 'overall survival', 'importance: performance status, ascites, size of the largest tumour, CA-125, platinum-free interval\xa0and primary platinum resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0475278', 'cui_str': 'Large tumor'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0578142,"In the PENELOPE validation cohort (C-statistic 0.59), the median OS in the good, intermediate and poor prognosis groups was 18.5, 10.3 and 5.8 months, respectively.","[{'ForeName': 'Chee Khoon', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia. Electronic address: chee.lee@ctc.usyd.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Medical Oncology, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gonzalez-Martin', 'Affiliation': 'Grupo Español de Investigación en Cáncer de Ovario (GEICO) and MD Anderson Cancer Center Spain, Madrid, Spain; Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Medical Oncology, Hôpital Privé du Confluent S.A.S., Nantes, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesoin', 'Affiliation': 'GINECO and Medical Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kurzeder', 'Affiliation': 'Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Dept. of Gynecology & Gynecologic Oncology, Klinikum Essen Mitte, Essen, Germany.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Largillier', 'Affiliation': 'Centre Azuréen de Cancérologie, Mougins, France.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'AGO and Dept. of Gynecology and Obstetrics, University Hospital Kiel, Kiel, Germany; Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""GINECO and Medical Oncology, Centre Armoricain d'Oncologie, CARIO, Plérins sur mer, France.""}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': 'GINECO and Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-Lès-Nancy, France.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'GEICO and Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'ARCAGY-GINECO.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.029']
2710,31301031,Prospective Longitudinal Trends in Body Composition and Clinical Outcomes 3 Years Following Sleeve Gastrectomy.,"BACKGROUND AND AIMS


Longitudinal assessment of body composition following bariatric surgery allows monitoring of health status. Our aim was to elucidate trends of anthropometric and clinical outcomes 3 years following sleeve gastrectomy (SG).
METHODS


A prospective cohort study of 60 patients who underwent SG. Anthropometrics including body composition analysis measured by multi-frequency bioelectrical impedance analysis, blood tests, liver fat content measured by abdominal ultrasound and habitual physical activity were evaluated at baseline and at 6 (M6), 12 (M12), and 36 (M36) months post-surgery.
RESULTS


Sixty patients (55% women, age 44.7 ± 8.7 years) who completed the entire follow-up were included. Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001). Fat free mass (FFM) decreased significantly during the first 6 months (64.7 ± 14.3 to 56.9 ± 11.8 kg; P < 0.001), slightly decreased between M6 and M12 and then reached a plateau through M36. Weight loss ""failure"" (< 50% excess weight loss) was noticed in 5.0% and 28.3% of patients at M12 and M36, respectively. Markers of lipid and glucose metabolism changed thereafter in parallel to the changes observed in FM, with the exception of HDL-C, which increased continuingly from M6 throughout the whole period analyzed (45.0 ± 10.2 to 59.5 ± 15.4 mg/dl; P < 0.001) and HbA1c which continued to decrease between M12 and M36 (5.5 ± 0.4 to 5.3 ± 0.4%; P < 0.001). There were marked within-person variations in trends of anthropometric and clinical parameters during the 3-year follow-up.
CONCLUSIONS


Weight regain primarily attributed to FM with no further decrease in FFM occurs between 1 and 3 years post-SG. FM increase at mid-term may underlie the recurrence of metabolic risk factors and can govern clinical interventions.",2019,"Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001).","['Years', '60 patients who underwent SG', 'Sixty patients (55% women, age 44.7\u2009±\u20098.7\xa0years) who completed the entire follow-up were included']","['Sleeve Gastrectomy', 'sleeve gastrectomy (SG']","['Fat free mass', 'FFM', 'Weight loss ""failure', 'Anthropometrics including body composition analysis measured by multi-frequency bioelectrical impedance analysis, blood tests, liver fat content measured by abdominal ultrasound and habitual physical activity', 'Markers of lipid and glucose metabolism', 'Fat mass (FM']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",60.0,0.0308344,"Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001).","[{'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sherf-Dagan', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel. shirisherf@gmail.com.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Zelber-Sagi', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Buch', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Bar', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Webb', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Sakran', 'Affiliation': 'Israeli Center for Bariatric Surgery (ICBS), Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Asnat', 'Initials': 'A', 'LastName': 'Raziel', 'Affiliation': 'Israeli Center for Bariatric Surgery (ICBS), Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goitein', 'Affiliation': 'Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Keidar', 'Affiliation': ""Department of General Surgery, Assuta Ashdod Public Hospital, The Ben-Gurion University, Be'er Sheva, Israel.""}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Shibolet', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}]",Obesity surgery,['10.1007/s11695-019-04057-2']
2711,31303147,Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study.,"Background : The once-daily, single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is approved for the treatment of HIV-1 infection. The 48-week efficacy and safety of D/C/F/TAF versus darunavir/cobicistat + emtricitabine/tenofovir disoproxil fumarate (control) in treatment-naïve adults were demonstrated in the phase 3 AMBER study.  Objective : To describe AMBER outcomes across patient subgroups based on demographic and clinical characteristics at baseline.  Methods : AMBER patients had viral load (VL) ≥1000 copies/mL, CD4 +  cell count >50 cells/µL, and genotypic susceptibility to darunavir, emtricitabine, and tenofovir. Primary endpoint was the proportion of patients with virologic response (VL <50 copies/mL; FDA snapshot). Safety was assessed by adverse events, estimated glomerular filtration rate (cystatin C; eGFR cystC ), and bone mineral density. Outcomes were assessed by age (≤/>50 years), gender, race (black/non-black), baseline VL (≤/>100,000 copies/mL), baseline CD4 +  cell count (</≥200 cells/µL), and baseline WHO clinical stage of HIV infection (1/2).  Results : For the 725 AMBER patients (D/C/F/TAF: 362; control: 363), virologic response rates at week 48 were similar with D/C/F/TAF (91%) and control (88%), and this was consistent across all subgroups. Adverse event rates were similar in both arms, although numerically higher among patients >50 years and women, relative to their comparator groups, regardless of treatment arm (notably, sample sizes were small for patients >50 years and women). Improvements in eGFR cystC  and stable bone mineral density were observed with D/C/F/TAF overall, and results were generally consistent across subgroups.  Conclusions : For treatment-naïve patients in AMBER, initiating therapy with the D/C/F/TAF single-tablet regimen was an effective and well-tolerated option, regardless of demographic or clinical characteristics.",2019,"Adverse event rates were similar in both arms, although numerically higher among patients >50 years and women, relative to their comparator groups, regardless of treatment arm (notably, sample sizes were small for patients >50 years and women).","['treatment-naïve adults', 'treatment-naïve patients with HIV-1']","[' ', 'Darunavir/cobicistat/emtricitabine/tenofovir alafenamide', 'D/C/F/TAF versus darunavir/cobicistat\u2009+\u2009emtricitabine/tenofovir disoproxil fumarate (control', 'cobicistat/emtricitabine/tenofovir alafenamide', 'emtricitabine, and tenofovir']","['adverse events, estimated glomerular filtration rate (cystatin C; eGFR cystC ), and bone mineral density', 'virologic response rates', 'proportion of patients with virologic response', 'viral load (VL', 'baseline CD4 +  cell count ', 'CD4 +  cell count', 'Adverse event rates', 'eGFR cystC  and stable bone mineral density']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]","[{'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C2929052', 'cui_str': 'tenofovir disoproxil and emtricitabine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.160304,"Adverse event rates were similar in both arms, although numerically higher among patients >50 years and women, relative to their comparator groups, regardless of treatment arm (notably, sample sizes were small for patients >50 years and women).","[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rashbaum', 'Affiliation': 'a Capital Medical Associates , Washington , DC , USA.'}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'b University Hospital Klinikum rechts der Isar, Technische Universität München , Munich , Germany.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'c Tarrant County Infectious Disease Associates , Fort Worth , TX , USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mussini', 'Affiliation': 'd University of Modena and Reggio Emilia , Modena , Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'e Janssen Research & Development, LLC , Pennington , NJ , USA.'}, {'ForeName': 'Donghan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'f Janssen Research & Development, LLC , Titusville , NJ , USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'g Janssen Research & Development , Beerse , Belgium.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'f Janssen Research & Development, LLC , Titusville , NJ , USA.'}, {'ForeName': 'Eric Y', 'Initials': 'EY', 'LastName': 'Wong', 'Affiliation': 'h Janssen Scientific Affairs, LLC , Titusville , NJ , USA.'}]",HIV research & clinical practice,['10.1080/15284336.2019.1608714']
2712,32464630,Dynamic Light Scattering: A New Noninvasive Technology for Neonatal Heart Rate Monitoring.,"BACKGROUND


Heart rate (HR) detection in premature infants using electrocardiography (ECG) is challenging due to a low signal amplitude and the fragility of the premature skin. Recently, the dynamic light scattering (DLS) technique has been miniaturized, allowing noninvasive HR measurements with a single sensor.
OBJECTIVE


The aim was to determine the accuracy of DLS for HR measurement in infants, compared to ECG-derived HR.
METHODS


Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion. HR was measured with the DLS sensor at 5 different sites for 15 min each. We recorded every 10th second of the DLS-derived HR and the DLS signal-to-noise ratio (SNR), and the ECG-derived HR was extracted for analysis. Patients were randomly divided into 2 groups. In the first group, the optimal SNR cut-off value was determined and then applied to the second group to assess agreement.
RESULTS


HR measurements from 31 infants were analyzed. ECG-DLS paired data points were collected at the forehead, an upper extremity, the thorax, a lower extremity, and the abdomen. When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66). Application of this cut-off to the second group (n = 16) showed good agreement between DLS-derived HR and ECG-derived HR (bias -0.73 bpm; 95% limits of agreement -15.46 and 14.00 bpm) at the forehead with approximately 80% (i.e., 1,066/1,310) of all data pairs remaining.
CONCLUSION


The investigated DLS sensor was sensitive to movement, overall providing less accurate HR measurements than ECG and pulse oximetry. In this study population, specific measurement sites provided excellent signal quality and good agreement with ECG-derived HR.",2020,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","['premature infants using', 'Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion']","['electrocardiography (ECG', 'Dynamic Light Scattering']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0023693', 'cui_str': 'Light'}]",[],31.0,0.0168291,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","[{'ForeName': 'Norani H', 'Initials': 'NH', 'LastName': 'Gangaram-Panday', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands, n.gangaram-panday@erasmusmc.nl.""}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'van Essen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Goos', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Rogier C J', 'Initials': 'RCJ', 'LastName': 'de Jonge', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Weteringen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}]",Neonatology,['10.1159/000506771']
2713,32464799,Extracorporeal Photopheresis as Induction Therapy after Lung Transplantation for Cystic Fibrosis: Interim Analysis.,"PURPOSE


Extracorporeal photopheresis has emerged as a promising treatment for chronic rejection. To date, there are no data on extracorporeal photopheresis as induction therapy. We are implementing a single-center, single blind, randomized controlled trial enrolling 24 recipients with cystic fibrosis (CF) who undergo lung transplantation (LTx) randomly allocated in 2 parallel arms: induction with extracorporeal photopheresis plus standard immunosuppressive therapy (ECP) vs. standard immunosuppressive therapy (CTR). We present the interim analysis focused on safety and immunomodulation effectiveness.
METHODS


We recorded every adverse event, including acute rejection (AR), which occurred in the first year after lung transplantation. Immune parameters (activated T cells, Treg, Th17, Th1, NK, PD-1 and PD-L1 expression, IL-10, TNFα, IL-1β, and IFNγ production) were evaluated at different time points in the first year after LTx. Preliminary data on the first ten patients (6 ECP and 4 CTR) are reported.
RESULTS


No AR episodes were observed and no adverse events due to extracorporeal photopheresis were recorded. In the control arm, one patient died of post-operative infection on 20th postoperative day. In ECP compared to CTR patients: 1) regulatory T cells (Treg) as well as IL10 production by Treg were increased; 2) IL17-secreting Th17 as well as Th1 T cells were reduced; 3) CD107+/CD8+ (perforin-releasing CTL) T lymphocytes were reduced, 4) IL10-producing NK cells were increased; 5) LPS-stimulated IL-10 production was augmented whereas that of TNFα and IL-1β was reduced.
CONCLUSION


In the setting of LTx for CF, extracorporeal photopheresis is well tolerated and it results in an overall modulation of immune responses. The positive result of this interim analysis led to the decision of continuing to enroll patients in this randomized trial with the aim of probing the possible positive effect of extracorporeal photopheresis as induction therapy in AR prevention.",2020,"Immune parameters (activated T cells, Treg, Th17, Th1, NK, PD-1 and PD-L1 expression, IL-10, TNFα, IL-1β, and IFNγ production) were evaluated at different time points in the first year after LTx.","['24 recipients with cystic fibrosis (CF) who undergo lung transplantation (LTx) randomly allocated in 2 parallel arms: induction with', 'Lung Transplantation for Cystic Fibrosis']","['CD107+/CD8+ (perforin-releasing CTL', 'extracorporeal photopheresis', 'extracorporeal photopheresis plus standard immunosuppressive therapy (ECP) vs. standard immunosuppressive therapy (CTR', 'Extracorporeal Photopheresis']","['acute rejection (AR', 'IL10-producing NK cells', 'IL-10 production', 'T lymphocytes', 'Immune parameters (activated T cells, Treg, Th17, Th1, NK, PD-1 and PD-L1 expression, IL-10, TNFα, IL-1β, and IFNγ production']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0070410', 'cui_str': 'Perforin'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0206373', 'cui_str': 'Extracorporeal photopheresis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",24.0,0.0321924,"Immune parameters (activated T cells, Treg, Th17, Th1, NK, PD-1 and PD-L1 expression, IL-10, TNFα, IL-1β, and IFNγ production) were evaluated at different time points in the first year after LTx.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Righi', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clerici', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Trabattoni', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rosso', 'Affiliation': 'Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fenizia', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magistrelli', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Diotti', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Prati', 'Affiliation': ""Department of Transfusion Medicine and Hematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tarsia', 'Affiliation': ""Pneumology Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Torretta', 'Affiliation': ""Department of Transfusion Medicine and Hematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nosotti', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.969']
2714,32464805,Waitlist Outcomes in Patients with Blood Group O during Continuous Flow Left Ventricular Assist Device Support.,"PURPOSE


Continuous flow left ventricular assist device (CF LVAD) supported patients with blood group O may wait longer for heart transplantation (HT), but it remains uncertain if during this waiting period such patients have greater morbidity and mortality from major adverse events (AEs).
METHODS


We conducted a UNOS database analysis of all patients that were waitlisted for HT after CF LVAD implantation from January 2006 to March 2019. Major demographics, waitlist times, waitlist mortality and occurrence of major AEs were retrieved. Patients were categorized as blood group O and non-blood group O. Post-transplant survival was also retrieved. Waitlist and post HT survival were assessed by Kaplan Meier analysis and Cox proportional hazard ratios were calculated. AEs during device support were compared by logistic regression.
RESULTS


Overall, 8,578 patients with CF LVADs were placed on the UNOS waitlist during the study period. As expected, Blood group O (n=4,115) had longer waitlist times (412 days, IQR: 102-576; non-O 250 days, IQR 39-323 days, p<0.0001) than non-blood group O (n=4,461) patients. There were no significant differences between groups in age and gender. Blood group O had a higher likelihood of driveline infections (OR: 1.40, 95% CI 1.19-1.64, p<0.001) and life-threatening ventricular arrhythmias (OR: 2.22, 95% CI 1.44-3.42, <p=0.001, figure1A). Interestingly, waitlist mortality was similar in both groups (HR: 1.01, 95% CI 0.84-1.21, p=0.95, figure1B), as well as post HT survival (HR 0.96, 95% CI 0.85-1.09, p=0.58, figure1C).
CONCLUSION


Despite more major AEs during CF LVAD support, patients with blood group O experience similar wait list and post HT survival.",2020,"Blood group O had a higher likelihood of driveline infections (OR: 1.40, 95% CI 1.19-1.64, p<0.001) and life-threatening ventricular arrhythmias (OR: 2.22, 95% CI 1.44-3.42, <p=0.001, figure1A).","['all patients that were waitlisted for HT after CF LVAD implantation from January 2006 to March 2019', 'patients with blood group', 'patients with blood group O may wait longer for heart transplantation (HT', 'Patients with Blood Group O during Continuous Flow Left Ventricular Assist Device Support', '8,578 patients with CF LVADs']",['Continuous flow left ventricular assist device (CF LVAD'],"['Waitlist and post HT survival', 'life-threatening ventricular arrhythmias', 'post HT survival', 'driveline infections', 'O experience similar wait list and post HT survival', 'waitlist mortality', 'Major demographics, waitlist times, waitlist mortality and occurrence of major AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0427625', 'cui_str': 'Blood group O'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",8578.0,0.191667,"Blood group O had a higher likelihood of driveline infections (OR: 1.40, 95% CI 1.19-1.64, p<0.001) and life-threatening ventricular arrhythmias (OR: 2.22, 95% CI 1.44-3.42, <p=0.001, figure1A).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Skendelas', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Mt Sinai Medical Center, New York, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Forest', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vukelic', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jakobleff', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'U P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.975']
2715,32456955,Evaluation of the effects of using 3D - patient specific models of displaced intra - articular calcaneal fractures in surgery.,"BACKGROUND


It was aimed to compare conventional surgery and three-dimensional (3D) model-assisted surgery used in the treatment of calcaneal fractures.
MATERIALS & METHODS


A total of 37 patients with unilateral calcaneal fractures were randomly divided into two groups as a conventional surgery group (n: 19) and a 3D model-assisted surgery group (n: 18). The preoperative, postoperative and last follow up angles of the Bohler and Gissane, calcaneal width and facet height were measured. The duration of the operation, blood loss volume, fluoroscopy usage, instrumentation time for both groups were recorded. Finally, the follow-up AOFAS scores were evaluated. A questionnaire was used to determine the perceptions of the resident doctors about the 3D model.
RESULTS


The duration of the operation, blood loss volume, fluoroscopy usage, instrumentation time for 3D model-assisted surgery group were 83.3 ± 4.6 minutes, 83.6 ± 4.6 ml, 6.8 ± 1.4 times and 13.0 ± 0.8 weeks, and as for conventional group they were 130.0 ± 5.8 minutes, 105.1 ± 5.6 minutes, 11.7 ± 1.5 ml, 22.2 ± 2.4 times and 13.3 ± 0.8 weeks, respectively (p < 0.0001). The both groups significantly restored Bohler angle, Gissane angle, calcaneal width and calcaneal facet height after operation (p < 0.0001). The 3D model-assisted group was significantly more succesful in restoration and protection of achieved correction of calcanel facet height (p < 0.0001). The difference was determined among the groups at the final follow-up examination with respect to the amount of change according the values achieved post-op. were significant in Bohler angle (p < 0.001), calcaneal facet height (p < 0.0001) and calcaneal widht (p = 0.017). There was no significant difference between AOFAS scores of the two groups at last follow-up. Resident doctors exhibited high scores of overall satisfaction with the use of a 3D printing model.
CONCLUSIONS


Compared to the conventional group, the 3D model-assisted group provide successful intervention and reduce operation, instrumentation time and the fluoroscopy usage with less blood loss. Performing 3D-assisted surgery helps the quality of reduction during the surgery and stability of internal fixation to protect achieved reduction at follow-up more succesfully.",2020,"The both groups significantly restored Bohler angle, Gissane angle, calcaneal width and calcaneal facet height after operation (p < 0.0001).","['37 patients with unilateral calcaneal fractures', 'displaced intra - articular calcaneal fractures in surgery']","['conventional surgery and three-dimensional (3D) model-assisted surgery', 'conventional surgery group (n: 19) and a 3D model-assisted surgery group']","['preoperative, postoperative and last follow up angles of the Bohler and Gissane, calcaneal width and facet height', 'duration of the operation, blood loss volume, fluoroscopy usage, instrumentation time', 'succesful in restoration and protection of achieved correction of calcanel facet height', 'restored Bohler angle, Gissane angle, calcaneal width and calcaneal facet height', 'calcaneal facet height', 'duration of the operation, blood loss volume, fluoroscopy usage, instrumentation time for 3D model', 'AOFAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0135061,"The both groups significantly restored Bohler angle, Gissane angle, calcaneal width and calcaneal facet height after operation (p < 0.0001).","[{'ForeName': 'Anil Murat', 'Initials': 'AM', 'LastName': 'Ozturk', 'Affiliation': 'Department of Ortopaedic Surgery, Faculty of Medicine, Ege University, Izmir, TURKEY.'}, {'ForeName': 'Mehmet Asim', 'Initials': 'MA', 'LastName': 'Ozer', 'Affiliation': 'Department of Anatomy Digital Imaging and 3D Modelling Laboratory, Faculty of Medicine, Ege University, Izmir, TURKEY.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Suer', 'Affiliation': 'Department of Ortopaedic Surgery, Faculty of Medicine, Ege University, Izmir, TURKEY.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Derin', 'Affiliation': 'Department of Anatomy Digital Imaging and 3D Modelling Laboratory, Faculty of Medicine, Ege University, Izmir, TURKEY.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Govsa', 'Affiliation': 'Department of Anatomy Digital Imaging and 3D Modelling Laboratory, Faculty of Medicine, Ege University, Izmir, TURKEY.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Aktuglu', 'Affiliation': 'Department of Ortopaedic Surgery, Faculty of Medicine, Ege University, Izmir, TURKEY. Electronic address: kemal.aktuglu@gmail.com.'}]",Injury,['10.1016/j.injury.2020.04.057']
2716,32456979,A 4-week endurance training program improves tolerance to mental exertion in untrained individuals.,"OBJECTIVES


The aim of this study was to investigate whether 4 weeks of endurance training could improve tolerance to mental exertion in untrained participants.
DESIGN


Longitudinal training study.
METHODS


Twenty untrained young adults (14 F, 6 M; 27.6±6.2 years) completed a 4-week training protocol in a randomised and counterbalanced order. Baseline and follow-up assessment were conducted over three sessions in the week preceding and following the training period. During session 1, participants completed an incremental maximal ramp test. During sessions 2 and 3 participants completed a 15min cycling time trial preceded by either a mental exertion or control conditions. Following baseline assessments, participants were randomised into a physical training or placebo group that completed the training intervention thrice weekly over four weeks.
RESULTS


The physical training resulted in increase in VO 2  peak relative to the placebo group (p=0.003). Linear Mixed Models utilising the control condition time trial performance as a covariate found the physical training group increased their time trial distance following the mental exertion condition to a greater extent than the placebo group (p=0.03). RPE during the time trial and perceptual measures of mental exertion did not significantly change between groups (all p>0.10) although interaction effects were observed when considering the RPE-power output relationship during the time trial.
CONCLUSIONS


Four weeks of endurance training increased tolerance to mental exertion in untrained participants during a subsequent physical performance, but not during prolonged cognitive performance. This finding suggests that the ability to tolerate mental exertion is trainable in at least some contexts and highlights the far-reaching benefits of endurance training.",2020,The physical training resulted in increase in VO 2  peak relative to the placebo group (p=0.003).,"['Twenty untrained young adults (14 F, 6 M; 27.6±6.2 years) completed a', 'untrained individuals', 'untrained participants']","['4-week training protocol', 'endurance training program', 'physical training or placebo', 'mental exertion or control conditions', 'physical training', 'endurance training', 'placebo']","['VO 2  peak relative', 'mental exertion', 'time trial distance', 'tolerance to mental exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",20.0,0.233526,The physical training resulted in increase in VO 2  peak relative to the placebo group (p=0.003).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Filipas', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy. Electronic address: luca.filipas@unimi.it.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Northey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keegan', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rattray', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.020']
2717,32456996,Is dermis fat arthroplasty better than plain gap arthroplasty? A prospective randomised controlled trial.,"The aim of the study was to compare interpositional arthroplasty using a dermis fat graft with gap arthroplasty in the management of ankylosis of the temporomandibular joint (TMJ). We organised a prospective randomised study of 22 patients who presented with ankylosis of the TMJ. They were randomised to be treated with either plain gap arthroplasty or dermis fat arthroplasty, and the predictor variable was the method of treatment. The primary outcome variables were mouth opening and pain on jaw exercises. Pain and interincisal opening were measured on day 5, day 14, at the end of one month, and at six months, one year, two years, and three years. There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018). The mean (SD) scores for mouth-opening were higher in the dermis fat group at all times (41.20 (4.69) mm compared with 39.50 (2.46) mm in gap arthroplasty at two years, and 41.40 (3.60) mm compared with 38.9 (2.02) mm at three years). The visual analogue pain scores were also lower in the dermis fat graft group. The groups showed similar results at the end of three years follow up, with no significant difference in mouth opening. We conclude therefore that the two techniques have similar outcomes in the management of ankylosis of the TMJ.",2020,There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018).,"['22 patients who presented with ankylosis of the TMJ', 'ankylosis of the temporomandibular joint (TMJ']","['plain gap arthroplasty or dermis fat arthroplasty', 'interpositional arthroplasty using a dermis fat graft with gap arthroplasty']","['Pain and interincisal opening', 'visual analogue pain scores', 'mouth opening', 'mean (SD) scores for mouth-opening', 'mouth opening and pain on jaw exercises']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.111565,There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018).,"[{'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Andrade', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: drnnadrade@yahoo.co.in.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: agg.neha61@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mathai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: paulmathai89@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nerurkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: nerurkarshibani@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Desai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: harshdesai1992@gmmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: varshagupta391@gmail.com.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.04.045']
2718,32456999,Patient Perception of Medical Student Professionalism: Does Attire Matter?,"INTRODUCTION


Patient compliance and outcomes have been shown to be influenced by the quality of the doctor-patient relationship. In addition, the effect of physician attire on the patient's perception of the physician has been long appreciated. Data shows that professional attire is preferred by patients. Whereas treating physicians are the backbone of patient management, medical students are often a patient's first encounter in a teaching clinic. Patient perception of the student may impact their rating of the attending physician. Despite this, medical students are often dressed wearing scrubs in surgery clinic. The purpose of this study was to determine if patient perception of medical students would be affected by the students' attire.
METHODS


A 7-item, validated professionalism scale was used to survey surgery clinic patients whose initial examinations were performed by a medical student. Students were blinded and randomly assigned to wear professional attire versus scrubs. Patients' responses of 'strongly agree' were compared to lower ratings for each item.
RESULTS


One hundred twenty-three patients completed our survey, 63 (51.2%) wearing scrubs and 60 (48.8%) in professional attire. The average age was 49.7 ± 15.8 years. In the professional attire group, there was no significant association for any of the 7 items. However, in the scrubs group, all 7 items were significant such that a higher proportion of patients under the age of 60 rated medical students wearing scrubs higher than did patients aged 60 and above.
CONCLUSION


Students in scrubs were perceived to be less knowledgeable, competent, and professional by older patients. In contrast, younger patients seemed unaffected by the dress of medical students in clinic. Older patients may judge the medical community's growing acceptance of more casual attire in the workplace as less professional, potentially affecting patient satisfaction. Surgical educators should require a standard of professional attire for students in clinic.",2020,"In the professional attire group, there was no significant association for any of the 7 items.","['Older patients', 'Students in scrubs were perceived to be less knowledgeable, competent, and professional by older patients', 'One hundred twenty-three patients completed our survey, 63 (51.2%) wearing scrubs and 60 (48.8%) in professional attire', 'patient perception of medical students', 'The average age was 49.7 ± 15.8 years']",['professional attire versus scrubs'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2946035', 'cui_str': 'Scrubs'}]",[],123.0,0.0153431,"In the professional attire group, there was no significant association for any of the 7 items.","[{'ForeName': 'Aabra', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Sharjeel', 'Initials': 'S', 'LastName': 'Israr', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona. Electronic address: Sharjeel.Israr@dignityhealth.org.""}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Chapple', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Weinberg', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Goslar', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Hayden', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Gagliano', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Gillespie', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.04.016']
2719,32457004,"Effects of upper extremity aerobic exercise training on oxygen consumption, exercise capacity, dyspnea and quality of life in patients with pulmonary arterial hypertension.","BACKGROUND


Pulmonary and extrapulmonary impairments are prevalent in pulmonary arterial hypertension (PAH) which is a rare, chronic and progressive disease.
OBJECTIVES


To investigate the effects of upper extremity aerobic exercise training on exercise capacity, oxygen consumption, dyspnea and quality of life in patients with PAH.
METHODS


In a prospective, randomized controlled, double-blinded study, eleven patients in training group applied upper extremity aerobic exercise training (50-80% of maximal heart rate), 15-45 min/day, 3 days a week for 6 weeks and 11 patients in control group alternating active upper extremity exercises for the same period. Exercise capacity evaluated using six minute walk test (6MWT), oxygen consumption simultaneously measured during 6MWT using a portable instrument, dyspnea modified Borg scale and Modified Medical Research Council dyspnea scale and quality of life Short Form 36 Health Survey, before and after the exercise training.
RESULTS


Baseline characteristics of groups were similar (p>0.05). Dyspnea (p<0.001) and peak oxygen consumption (p = 0.031) were significantly improved in training group compared the controls. Dyspnea, exercise capacity, peak oxygen consumption, minute ventilation, tidal volume, end tidal carbon-dioxide pressure, and vitality, social functioning and role-physical were significantly improved within training group (p<0.05). Oxygen consumption at anaerobic threshold were significantly decreased within control group (p<0.05).
CONCLUSIONS


Upper extremity aerobic exercise training improves oxygen consumption, and decreases dyspnea perception. It is a safe and effective intervention in patients with PAH. (ClinicalTrials.gov registration: NCT02371733).",2020,"Oxygen consumption at anaerobic threshold were significantly decreased within control group (p<0.05).
","['patients with PAH', 'patients with pulmonary arterial hypertension', 'eleven patients in']","['upper extremity aerobic exercise training', 'control group alternating active upper extremity exercises', 'Upper extremity aerobic exercise training', 'training group applied upper extremity aerobic exercise training']","['oxygen consumption', 'exercise capacity, oxygen consumption, dyspnea and quality of life', 'Dyspnea (p<0.001) and peak oxygen consumption', 'dyspnea perception', 'Dyspnea, exercise capacity, peak oxygen consumption, minute ventilation, tidal volume, end tidal carbon-dioxide pressure, and vitality, social functioning and role-physical', 'Oxygen consumption at anaerobic threshold', 'Exercise capacity evaluated using six minute walk test (6MWT), oxygen consumption simultaneously measured during 6MWT using a portable instrument, dyspnea modified Borg scale and Modified Medical Research Council dyspnea scale and quality of life Short Form 36 Health Survey', 'oxygen consumption, exercise capacity, dyspnea and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",11.0,0.0943469,"Oxygen consumption at anaerobic threshold were significantly decreased within control group (p<0.05).
","[{'ForeName': 'Burcu Camcıoğlu', 'Initials': 'BC', 'LastName': 'Yılmaz', 'Affiliation': 'Muğla Sıtkı Koçman University Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Kötekli Mah., Muğla 48000, Turkey. Electronic address: burcu.camcioglu@yahoo.com.'}, {'ForeName': 'Meral Boşnak', 'Initials': 'MB', 'LastName': 'Güçlü', 'Affiliation': 'Gazi University Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Müşerrefe Nur', 'Initials': 'MN', 'LastName': 'Keleş', 'Affiliation': 'Gazi University Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gülten Aydoğdu', 'Initials': 'GA', 'LastName': 'Taçoy', 'Affiliation': 'Gazi University Faculty of Medicine, Department of Cardiology, Ankara, Turkey.'}, {'ForeName': 'Atiye', 'Initials': 'A', 'LastName': 'Çengel', 'Affiliation': 'Gazi University Faculty of Medicine, Department of Cardiology, Ankara, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.04.006']
2720,32457012,Metoclopramide Reduces Fluoroscopy and Procedure Time during Gastrojejunostomy Tube Placement: A Placebo-Controlled Trial.,"PURPOSE


To determine whether a single 10-mg intravenous dose of the promotility agent metoclopramide reduces the fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement.
METHODS


This prospective, randomized, double-blind, placebo-controlled trial enrolled consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019. Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy. Average fluoroscopy times, radiation doses, and procedure times were compared using t-tests. The full study protocol can be found at www.clinicaltrials.gov (NCT03331965).
RESULTS


Of 110 participants randomized 1:1, 45 received metoclopramide and 51 received placebo and underwent GJ tube placement (38 females and 58 males; mean age, 55 ± 18 years). Demographics of the metoclopramide and placebo groups were similar. The fluoroscopy time required to advance a guide wire through the pylorus averaged 1.6 minutes (range, 0.3-10.1 minutes) in the metoclopramide group versus 4.1 minutes (range, 0.2-27.3 minutes) in the placebo group (P = .002). Total procedure fluoroscopy time averaged 5.8 minutes (range, 1.5-16.2 minutes) for the metoclopramide group versus 8.8 minutes (range, 2.8-29.7 minutes) for the placebo group (P = .002). Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04). Total procedure time averaged 16.4 minutes (range, 8-51 minutes) for the metoclopramide group versus 19.9 minutes (range, 6-53 minutes) for the placebo group (P = .04). There were no drug-related adverse events and no significant differences in procedure-related complications.
CONCLUSIONS


A single dose of metoclopramide reduced fluoroscopy time by 34%, radiation dose by 30%, and procedure time by 17% during GJ tube placement.",2020,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","['consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019', '110 participants randomized 1:1, 45 received', 'Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy', '38 females and 58 males; mean age, 55 ± 18 years']","['metoclopramide and placebo', 'Placebo', 'Metoclopramide', 'metoclopramide', 'GJ tube placement', 'placebo']","['procedure-related complications', 'fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement', 'Total procedure time', 'Average fluoroscopy times, radiation doses, and procedure times', 'fluoroscopy time', 'Total procedure fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532670', 'cui_str': 'Obtaining consent'}, {'cui': 'C0570599', 'cui_str': 'Allergy to metoclopramide'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",110.0,0.369738,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DuRocher', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Olivas', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whited', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Langston', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ronald', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710. Electronic address: james.ronald@duke.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.028']
2721,32457075,Cholinergic modulation of binocular vision.,"The endogenous neurotransmitter acetylcholine (ACh) is known to affect the excitatory/inhibitory (E/I) balance of primate visual cortex, enhancing feedforward thalamocortical gain while suppressing cortico-cortical synapses. Recent advances in the study of the human visual system suggest that ACh is a likely component underlying interocular interactions. However, our understanding of its precise role in binocular processes is currently lacking. Here we use binocular rivalry as a probe of interocular dynamics to determine ACh's effects - via the acetylcholinesterase inhibitor (AChEI) donepezil - on the binocular visual system. 23 Subjects (13 male) completed two cross-over experimental sessions where binocular rivalry measurements were obtained before and after taking either donepezil (5 mg) or a placebo (lactose) pill. We report that enhanced cholinergic potentiation attenuates perceptual suppression during binocular rivalry, reducing the overall rate of interocular competition while enhancing the visibility of superimposition mixed percepts. Considering recent evidence that perceptual suppression during binocular rivalry is causally modulated by the inhibitory neurotransmitter GABA, our results suggest that cholinergic activity counteracts the effect of GABA with regards to interocular dynamics and may modulate the inhibitory drive within the visual cortex. SIGNIFICANCE STATEMENT Our research demonstrates that the cholinergic system is implicated in modulating binocular interactions in the human visual cortex. Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",2020,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",['23 Subjects (13 male'],"['placebo (lactose) pill', 'acetylcholinesterase inhibitor (AChEI) donepezil ', 'acetylcholine', 'donepezil']",['binocular rivalry measurements'],"[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",23.0,0.0594407,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.","[{'ForeName': 'Yasha', 'Initials': 'Y', 'LastName': 'Sheynin', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, QC, Canada, H3G 1A4.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rosa-Neto', 'Affiliation': 'Douglas Mental Health University Institute, McGill University, Montréal, QC, Canada, H4H 1R3.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hess', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, QC, Canada, H3G 1A4 robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Vaucher', 'Affiliation': ""Laboratoire de Neurobiologie de la Cognition Visuelle, École d'Optométrie, Université de Montréal, QC, Canada, H3T 1P1 robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.""}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2484-19.2020']
2722,32457257,Feasibility of laparoscopic liver resection for liver cavernous hemangioma: A single-institutional comparative study.,"Backgrounds/Aims


While minimal invasive surgery has become popular, the feasibility of laparoscopy for liver cavernous hemangioma has not been shown.
Methods


Patients who underwent hepatectomy for liver cavernous hemangioma from January 2008 to February 2019 at the Samsung Medical Center were reviewed. Patients who underwent trisectionectomy were excluded. Background characteristics, along with operative and postoperative recovery, were compared between the laparoscopy and open surgery groups.
Results


Forty-three patients in the laparoscopy group and 33 patients in the open surgery group were compared. The differences in the background characteristics were presence of symptoms (14.6% in laparoscopy vs. 57.1% in open,  p <0.001) and tumor location (right, left and both side  p =0.017). The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001,  p =0.017 each). There was no significant difference in complication after surgery between two groups ( p =0.721). All the patients showed pathologic report of benign hemangioma regardless of type of surgery (100%). Almost every patients reported no symptom or relief of symptom in both groups (97.7%, 93.9% each).
Conclusions


Laparoscopic liver resection for liver cavernous hemangioma can be safely performed with improved postoperative recovery. However, surgery for liver cavernous hemangioma should be conducted with informed consent of the patients.",2020,"The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001,  p =0.017 each).","['Methods\n\n\nPatients who underwent hepatectomy for liver cavernous hemangioma from January 2008 to February 2019 at the Samsung Medical Center were reviewed', 'liver cavernous hemangioma', 'Patients who underwent trisectionectomy were excluded']","['laparoscopy', 'laparoscopic liver resection']","['blood transfusion requirements', 'smaller blood loss', 'shorter hospital stay', 'earlier drain removal', 'lower level of post-operative total bilirubin, prothrombin time (INR', 'earlier soft diet start', 'shorter amount and duration of additional pain control', 'symptom or relief of symptom', 'complication']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0238246', 'cui_str': 'Hemangioma of liver'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0301569', 'cui_str': 'Soft diet'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0447011,"The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001,  p =0.017 each).","[{'ForeName': 'Younghuen', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jinsoo', 'Initials': 'J', 'LastName': 'Rhu', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gyu-Seong', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae-Won', 'Initials': 'JW', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Choon Hyuck David', 'Initials': 'CHD', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Annals of hepato-biliary-pancreatic surgery,['10.14701/ahbps.2020.24.2.137']
2723,32457366,Efficacy of water spray for evaporative cooling in athletes with spinal cord injury.,"STUDY DESIGN


Interventional crossover study.
OBJECTIVE


Spinal cord injury (SCI) disrupts afferent input to the hypothalamus and impairs efferent vaso- and sudomotor output, especially in lesions above the sympathetic chain (T1-L2). In consequence, persons with SCI under heat stress experience impairment in the ability to dissipate heat proportional to the lesion level. Thermoregulatory dysfunction places an individual at high risk of hyperthermia, which can be life threatening, especially for athletes with SCI during exercise. Current evidence on therapeutic cooling techniques in athletes with SCI is limited, but basic physiologic and research data suggest water spray (WS) might be efficacious, particularly in athletes with tetraplegia (TP), who are most impaired in thermoregulation. The aim of this study was to evaluate the effect of WS on core temperature (Tc) during exercise in athletes with SCI.
SETTING


Texas, USA.
METHODS


Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a wheelchair intermittent sprint exercise for 90 min under two conditions: (1) WS application every 15 min and (2) control (C), without WS. Tc was measured every 15 min and was analyzed for the effect of group (TP, PP, and AB) and time. Change in Tc (ΔTc) was also compared between groups.
RESULTS


ΔTc was significantly higher in TP vs. PP (p < 0.0001) and TP vs. AB (p < 0.0001) groups under C treatment. WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB.
CONCLUSION


WS effectively attenuated Tc elevation during exercise in athletes with TP.
SPONSORSHIP


Texas chapter of the Paralyzed Veterans of America.",2019,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB.
CONCLUSION


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","['Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a', 'athletes with tetraplegia (TP', 'SPONSORSHIP\n\n\nTexas chapter of the Paralyzed Veterans of America', 'athletes with spinal cord injury', 'athletes with SCI.\nSETTING\n\n\nTexas, USA', 'athletes with SCI']","['wheelchair intermittent sprint exercise for 90\u2009min under two conditions: (1) WS application every 15\u2009min and (2) control (C), without WS', 'water spray']","['core temperature (Tc', 'TP vs. PP', 'Change in Tc (ΔTc', 'Tc elevation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",11.0,0.0318801,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB.
CONCLUSION


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trbovich', 'Affiliation': 'Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. trbovichm@uthscsa.edu.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Koek', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'School of Health Professions, Physical Therapy Department, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0194-8']
2724,32457373,Participatory practices at work change attitudes and behavior toward societal authority and justice.,"Generalized attitudes toward authority and justice are often conceptualized as individual differences that are resistant to enduring change. However, across two field experiments with Chinese factory workers and American university staff, small adjustments to people's experience of participation in the workplace shifted these attitudes one month later. Both experiments randomly assigned work groups to a 20-minute participatory meeting once per week for six weeks, in which the supervisor stepped aside and workers discussed problems, ideas, and goals regarding their work (vs. a status quo meeting). Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making. These findings provide rare experimental evidence of the theoretical predictions regarding participatory democracy: that local participatory experiences can influence broader democratic attitudes and empowerment.",2020,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.",[],[],[],[],[],[],,0.0149299,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.","[{'ForeName': 'Sherry Jueyu', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'Collins Center A-415, Anderson School of Management, University of California Los Angeles, Los Angeles, CA, 90095, USA. sherry.wu@anderson.ucla.edu.'}, {'ForeName': 'Elizabeth Levy', 'Initials': 'EL', 'LastName': 'Paluck', 'Affiliation': '420 Peretsman Scully Hall, Department of Psychology, Princeton University, Princeton, NJ, 08544, USA.'}]",Nature communications,['10.1038/s41467-020-16383-6']
2725,32457427,Early cessation of a randomised study in acute graft versus host disease: upfront mesenchymal stromal cells with corticosteroids versus corticosteroids alone.,,2020,,[],['corticosteroids versus corticosteroids alone'],[],[],"[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0355741,,"[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Purtill', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia. Duncan.purtill@health.wa.gov.au.'}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Cirillo', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Fogarty', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Cooney', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cannell', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Herrmann', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Sturm', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}]",Bone marrow transplantation,['10.1038/s41409-020-0955-9']
2726,32457492,Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.,"A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.",2020,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","['subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties', 'Treatment-Seeking Alcohol Use Disorder patients with sleeping problems', 'Sixty treatment-seeking AUD subjects']","['Melatonin', 'melatonin', 'placebo']","['sleeping problems', 'global PSQI score', 'sleeping quality', 'Pittsburgh sleep quality index (PSQI) scale']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0808956,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","[{'ForeName': 'Marie N S', 'Initials': 'MNS', 'LastName': 'Gendy', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lagzdins', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Schaman', 'Affiliation': 'Alcohol Research and Treatment Clinic, Acute Care Program, CAMH, Toronto, M6J 1H4, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada. bernard.lefoll@camh.ca.'}]",Scientific reports,['10.1038/s41598-020-65166-y']
2727,32457513,A mobile-based educational intervention on sexo-marital life in Iranian men with spinal cord injury: a randomized controlled trial.,"STUDY DESIGN


A randomized controlled trial.
OBJECTIVE


To assess the effectiveness of a mobile-based educational intervention on sexo-marital life in Iranian men with spinal cord injury (SCI).
SETTING


Foundation of Martyrs and Veterans Affairs', ""Spinal Cord Injury Association"", and the ""Protection Center of Spinal Cord Disables"".
METHODS


Participants were men with SCI aged at least 18 years old. The effectiveness of a mobile App was evaluated on 70 married men with SCI. Sexual adjustment, sexual satisfaction, marital adjustment, and marital satisfaction were assessed by valid and reliable questionnaires at baseline, 4 and 8 weeks after the intervention.
RESULTS


The between-group mean difference (95% CI) of sexual adjustment (4.2, CI: 3.6-4.8) after 4 weeks as well as 8 weeks (8.6, CI: 7.6-9.5) after baseline was significant (P < 0.001). The between-group mean difference (95% CI) of sexual satisfaction (6.9, CI: 8-11.2) after 4 weeks as well as 8 weeks (16.4, CI: 14.1-18.7) after baseline was significant (P < 0.001). There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001). Repeated measures ANOVA showed there was no statistically significant increase in marital adjustment's between-group mean difference (95% CI) after 4 weeks (-0.1, CI: -0.1- 0, P < 0.16) as well as 8 weeks (0.4, CI: -0.3-1.1, P < 0.25) after baseline.
CONCLUSION


The application-based educational intervention showed the positive effect of education on sexo-marital life in men with SCI. We recommend the rehabilitation team's healthcare providers embrace this educational strategy for individuals with SCI.",2020,There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001).,"['Iranian men with spinal cord injury', 'Iranian men with spinal cord injury (SCI', 'Participants were men with SCI aged at least 18 years old', 'individuals with SCI', '70 married men with SCI', 'men with SCI']","['mobile App', 'mobile-based educational intervention']","['sexo-marital life', ""marital satisfaction's"", ""marital adjustment's"", 'Sexual adjustment, sexual satisfaction, marital adjustment, and marital satisfaction', 'sexual satisfaction']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}]",70.0,0.352686,There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zarei', 'Affiliation': 'Department of Health Education & Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University (TMU), Tehran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Rashedi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tavousi', 'Affiliation': 'Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Haeri-Mehrizi', 'Affiliation': 'Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Maasoumi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. r_masoumi@sina.tums.ac.ir.'}]",Spinal cord,['10.1038/s41393-020-0489-4']
2728,32458080,"Effectiveness of a combined 308-nm excimer lamp and topical mid-potent steroid treatment for facial vitiligo: a preliminary, randomized double-blinded controlled study.","Facial vitiligo has considerable psychological and emotional impacts. Though topical corticosteroids are the mainstay treatment, adverse reactions are a concern for prolonged use. Additionally, 308-nm excimer lamps have been widely used in vitiligo. This study aimed to assess the effectiveness of a combined 308-nm excimer lamp and topical steroid therapy compared with the lamp alone for treating facial vitiligo. Symmetrical, nonsegmental facial vitiligo subjects were recruited. All facial lesions were irradiated with a 308-nm excimer lamp twice weekly for a total of 24 sessions. The lesions on each side of the face were randomly allocated to have topical mometasone furoate cream or the cream base alone applied once daily for 12 weeks. Clinical improvement was evaluated by a blinded dermatologist and the participants. A total of sixteen sides of the face were assessed in the study. By the 12th week, 87.5% of the lesions treated with the combination regimen and 50% of the lesions treated with monotherapy showed good to excellent repigmentation. From the subjects' perspectives, there were significant differences between both treatments at week 4 and week 8 (p = 0.05) but not at week 12. No serious adverse effects were reported. A combination of excimer lamp therapy and once-daily application of topical mometasone cream was effective and could accelerate the treatment outcomes without serious adverse reactions. This may be an alternative regimen for treating facial vitiligo.",2020,No serious adverse effects were reported.,"['treating facial vitiligo', 'facial vitiligo', 'Symmetrical, nonsegmental facial vitiligo subjects']","['excimer lamp therapy', 'monotherapy', 'topical mometasone furoate cream', 'lamp alone', 'combined 308-nm excimer lamp and topical steroid therapy', '308-nm excimer lamp', 'combined 308-nm excimer lamp and topical mid-potent steroid treatment', 'topical mometasone cream']",['serious adverse effects'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0667581,No serious adverse effects were reported.,"[{'ForeName': 'Premjit', 'Initials': 'P', 'LastName': 'Juntongjin', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, 10th Floor, Cooperative Learning Center, Piyachart2 Building, 99 Moo 18, Phaholyothin Road, Klong Luang, Pathum Thani, 12120, Thailand. premjitvp@yahoo.com.'}, {'ForeName': 'Nuttanit', 'Initials': 'N', 'LastName': 'Toncharoenphong', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, 10th Floor, Cooperative Learning Center, Piyachart2 Building, 99 Moo 18, Phaholyothin Road, Klong Luang, Pathum Thani, 12120, Thailand.'}]",Lasers in medical science,['10.1007/s10103-020-03048-5']
2729,32458091,Executive function training in very preterm children: a randomized controlled trial.,"Objective of the current study was to assess whether game-formatted executive function (EF) training, is effective in improving attention, EF and academic performance in very preterm and/or extremely low birthweight children aged 8-12 years. A multi-center, double-blind, placebo- and waitlist controlled randomized trial (NTR5365) in two academic hospitals in The Netherlands was performed. Eighty-five very preterm children with parent-rated attention problems on the Child Behavior Checklist were randomized to one of three treatment conditions: EF training, placebo training or waitlist condition. EF or placebo training was completed at home (6 weeks, 25 sessions of 30-45 min each). At baseline, 2 weeks after training or being on the waitlist, and five months after first follow-up visit, children underwent assessments of primary outcomes (parent and teacher ratings of attention) and secondary outcomes (parent and teacher ratings of daily-life EF, computerized EF tasks and academic performance). Linear mixed model analyses were performed for all outcome measures. There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition. In conclusion, game-formatted EF training does not improve attention, EF or academic performance in very preterm children with parent-rated attention problems.",2020,"There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition.","['very preterm children', 'very preterm and/or extremely low birthweight children aged 8-12\xa0years', 'Eighty-five very preterm children with parent-rated attention problems on the Child Behavior Checklist', 'two academic hospitals in The Netherlands was performed', 'very preterm children with parent-rated attention problems']","['game-formatted EF training', 'Executive function training', 'EF training, placebo training or waitlist condition', 'EF or placebo', 'game-formatted executive function (EF) training', 'placebo']","['attention, EF or academic performance', 'improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading', 'attention, EF and academic performance', 'teacher ratings of attention) and secondary outcomes (parent and teacher ratings of daily-life EF, computerized EF tasks and academic performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",85.0,0.465743,"There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition.","[{'ForeName': 'Carolien A', 'Initials': 'CA', 'LastName': 'van Houdt', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. c.a.vanhoudt@amsterdamumc.nl.""}, {'ForeName': 'Aleid G', 'Initials': 'AG', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': ""Department of Pediatrics, Amsterdam UMC, University of Amsterdam, Emma Neuroscience Group at Emma Children's Hospital, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Marsh', 'Initials': 'M', 'LastName': 'Königs', 'Affiliation': ""Emma Neuroscience Group, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Koopman-Esseboom', 'Affiliation': 'Department of Neonatology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands.'}, {'ForeName': 'A R Céleste', 'Initials': 'ARC', 'LastName': 'Laarman', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, The Netherlands.""}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'van Kaam', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Cornelieke S H', 'Initials': 'CSH', 'LastName': 'Aarnoudse-Moens', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}]",European child & adolescent psychiatry,['10.1007/s00787-020-01561-0']
2730,32458092,Retrospective analysis of different regimens for Chinese adults with severe newly diagnosed immune thrombocytopenia.,"To review the efficacy and safety of glucocorticoids combined with different regimens for treating severe immune thrombocytopenia (ITP). Eighty-five severe ITP patients from 2 tertiary hospitals treated with glucocorticoids were enrolled from January 2018 to May 2019 and divided into 4 treatment groups: group A (treated with glucocorticoids), group B (glucocorticoids plus intravenous immunoglobulin (IVIg)), group C (glucocorticoids plus recombinant human thrombopoietin (rhTPO)), and group D (glucocorticoids plus IVIg and rhTPO). Statistical analysis was performed with SPSS 19.0 software. Early responses and response maintenance were assessed at 14 days and 1 month after treatment. Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05). Adverse reaction incidences were not significantly different among all groups (P > 0.05). Severe ITP patients who received glucocorticoids with IVIg and rhTPO had higher CRs and ORs at the platelet level, and no significant adverse reactions were observed. Glucocorticoids combined with different regimens had different clinical efficacies for treating severe ITP.",2020,"Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05).","['severe immune thrombocytopenia (ITP', 'Chinese adults with severe newly diagnosed immune thrombocytopenia', 'Eighty-five severe ITP patients from 2 tertiary hospitals treated with']","['Glucocorticoids', 'glucocorticoids with IVIg and rhTPO', 'glucocorticoids', 'glucocorticoids), group B (glucocorticoids plus intravenous immunoglobulin (IVIg)), group C (glucocorticoids plus recombinant human thrombopoietin (rhTPO)), and group D (glucocorticoids plus IVIg and rhTPO']","['Adverse reaction incidences', 'adverse reactions', 'complete response (CR) and overall response (OR) rates', 'Early responses and response maintenance']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",85.0,0.0708333,"Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05).","[{'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Huai'an Second People's Hospital, Huai'an, Jiangsu, People's Republic of China.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gui', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hui', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China. gbc1987@163.com.""}]",Clinical and experimental medicine,['10.1007/s10238-020-00630-7']
2731,32458093,Enhanced super-mini-PCNL (eSMP): low renal pelvic pressure and high stone removal efficiency in a prospective randomized controlled trial.,"OBJECTIVE


In the present prospective randomized controlled trial (RCT), enhanced-SMP (eSMP) and conventional Chinese mini-PCNL (mPCNL) were compared to test the low renal pelvic pressure (RPP) and high stone removal efficiency in eSMP.
MATERIALS AND METHODS


Hundred patients with 2-5 cm renal calculus were enrolled. Renal pelvic pressure, operation time, lithotripsy time, removed stone volume, and complications were compared between eSMP and mPCNL statistically.
RESULTS


There was no significant difference in removed stone volume between mPCNL and eSMP (8.09 ± 3.36 vs. 7.88 ± 3.07 mm 3 , t = 0.320, p = 0.750), lithotripsy time in mPCNL was longer than eSMP (49.6 ± 19.5 vs. 34.9 ± 14.2 min, t = 4.152, p < 0.001), thus stone removal efficiency was higher in eSMP (13.71 ± 1.18 vs. 9.82 ± 1.24 mm 3 /h, t = 15.499, p < 0.001). Intra-operative RPP in mPCNL was higher than eSMP (17.72 ± 3.33 vs. 12.03 ± 2.37 mmHg, t = 9.524, p < 0.001); accumulated time of backflow status (RPP > 30 mmHg) in mPCNL was longer than eSMP (23.3 ± 16.9 vs. 3.7 ± 4.2 s, t = 7.710, p < 0.001). There was no significant difference in postoperative fever rate between mPCNL and eSMP (12.77% vs. 4.34%, χ 2  = 2.095, p = 0.148), nor final stone-free rate (87.2% vs. 91.3%, χ 2  = 0.401, p = 0.526). Hospital stay in eSMP was shorter than mPCNL (2.54 ± 0.72 vs. 3.00 ± 0.88, t = 2.724, p = 0.008).
CONCLUSION


Enhanced SMP (eSMP) was safe and effective in the management of 2-5 cm renal calculus. It can keep a lower renal pelvic pressure and a higher stone removal efficiency when compared to conventional Chinese mini-PCNL.
CLINICAL TRIAL REGISTRATION


NC03206515.",2020,"It can keep a lower renal pelvic pressure and a higher stone removal efficiency when compared to conventional Chinese mini-PCNL.
CLINICAL TRIAL REGISTRATION


NC03206515.",['Hundred patients with 2-5\xa0cm renal calculus were enrolled'],"['enhanced-SMP (eSMP) and conventional Chinese mini-PCNL (mPCNL', 'Enhanced super-mini-PCNL (eSMP', 'SMP (eSMP']","['removed stone volume', 'stone removal efficiency', 'Hospital stay in eSMP', 'renal pelvic pressure', 'lithotripsy time in mPCNL', 'final stone-free rate', 'postoperative fever rate', 'time of backflow status', 'low renal pelvic pressure (RPP', 'Renal pelvic pressure, operation time, lithotripsy time, removed stone volume, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0227666', 'cui_str': 'Renal pelvis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",0.0,0.0398232,"It can keep a lower renal pelvic pressure and a higher stone removal efficiency when compared to conventional Chinese mini-PCNL.
CLINICAL TRIAL REGISTRATION


NC03206515.","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China.'}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China. gzgyzgh@vip.sina.com.'}]",World journal of urology,['10.1007/s00345-020-03263-3']
2732,32464949,Results from the REPAIR Study Final Analysis: Effects of Macitentan on Right Ventricular (RV) Remodelling in Pulmonary Arterial Hypertension (PAH).,"PURPOSE


To evaluate the effect of macitentan on RV and hemodynamic properties in PAH patients.
METHODS


REPAIR (NCT02310672) was a 52-week, open-label, single-arm, multicentre study evaluating the effect of macitentan on cardiopulmonary hemodynamics, RV remodelling and function. Primary endpoints were change from baseline (BL) to Week 26 in RV stroke volume (RVSV), determined by cardiac MRI; and pulmonary vascular resistance (PVR), determined by right heart catheterization. Secondary endpoints included change from BL to Week 26 in MRI RV cavity volumes and myocardial mass, 6-minute walk distance (6MWD) and WHO functional class (FC). Macitentan 10 mg was initiated in treatment-naïve patients, in patients receiving stable background phosphodiesterase type-5 inhibitor [PDE-5i] at BL, or in initial combination with PDE-5i. At a pre-specified interim analysis in 42 patients, both primary endpoints were met. Final supportive analyses included 71 patients with BL and post-BL data for both primary endpoints (modified Full Analysis Set; mFAS). Safety was assessed up to end of study treatment + 30 days in all patients who received ≥1 dose of macitentan (N=87).
RESULTS


In the mFAS at BL, mean (SD) age was 45.2 (13.4) years, 57 (80.3%) patients were female, and most patients were FC II (34; 47.9%) and FC III (36; 50.7%); macitentan was initiated as monotherapy in 17 (23.9%) patients, on top of stable background PDE-5i therapy in 27 (38.0%) patients and simultaneously with a PDE-5i in 27 (38.0%) patients. RVSV increased by 12 mL and PVR decreased by 38% from BL at Week 26 (Table). Meaningful improvements in MRI and 6MWD secondary endpoints were also observed (Table). At Week 26, WHO FC (N=71) improved in 40 (56.3%) and was unchanged in 30 (42.3%) patients; none worsened, 1 had missing data. The most common adverse events were peripheral oedema (21.8%), headache (20.7%) and dizziness (13.8%).
CONCLUSION


REPAIR, the first multicentre study in PAH to use RVSV from cardiac MRI as a primary endpoint, showed significant, clinically-relevant improvements in RV function with macitentan as monotherapy or part of combination therapy. Safety was consistent with other macitentan clinical trial data.",2020,"The most common adverse events were peripheral oedema (21.8%), headache (20.7%) and dizziness (13.8%).
","['Pulmonary Arterial Hypertension (PAH', 'PAH patients']","['stable background phosphodiesterase type-5 inhibitor [PDE-5i] at BL, or in initial combination with PDE-5i']","['headache', 'dizziness', 'Safety', 'peripheral oedema', 'RV and hemodynamic properties', 'change from baseline (BL) to Week\xa026 in RV stroke volume (RVSV), determined by cardiac MRI; and pulmonary vascular resistance (PVR), determined by right heart catheterization', 'RVSV', 'cardiopulmonary hemodynamics, RV remodelling and function', 'PVR', 'change from BL to Week 26 in MRI RV cavity volumes and myocardial mass, 6-minute walk distance (6MWD) and WHO functional class (FC', 'RV function']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0030123', 'cui_str': '4-Aminohippuric Acid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",71.0,0.080418,"The most common adverse events were peripheral oedema (21.8%), headache (20.7%) and dizziness (13.8%).
","[{'ForeName': 'A Vonk', 'Initials': 'AV', 'LastName': 'Noordegraaf', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Channick', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cottreel', 'Affiliation': 'Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kiely', 'Affiliation': 'Royal Hallamshire Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Moiseeva', 'Affiliation': 'Almazov National Medical Research Centre, St Petersburg, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Scottish Pulmonary Vascular Unit, Glasgow, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tawakol', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation CMKP at European Health Center, Otwock, Poland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': '(co-last authors); Heart Center at the University of Cologne, and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Galiè', 'Affiliation': '(co-last authors); Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, Bologna, Italy.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1140']
2733,32464953,Intra-Operative Amiodarone-Releasing Hydrogel to Prevent Post Lung Transplant Atrial Fibrillation: A Pilot Clinical Trial.,"PURPOSE


The purpose of this study was to evaluate the effectiveness of topical amiodarone applied to the atria and pulmonary veins at the time of lung transplantation (LTx) in decreasing postoperative atrial fibrillation (POAF).
METHODS


Twenty patients undergoing LTx at a single institution were enrolled in this prospective pilot study and compared to 40 historical controls. An Amiodarone-containing hydrogel was created using CoSeal Surgical Sealant (Baxter Healthcare) and Amiodarone, which was applied to the pulmonary vein anastomoses and atria at time of LTx in the study group. The primary endpoint was development of POAF. Data for the control group was obtained by retrospective chart review.
RESULTS


The demographic and clinical information for both groups is demonstrated in Table 1. In the study group, 6 patients (30%) developed POAF (Figure 1), 2 (10%) of which lasted less than 24 hours in duration. In the control group, 18 (52.9%) patients developed POAF, 9 (26.5%) of which lasted less than 24 hours in duration. Three patients in the study group and 4 control patients required cardioversion. In the study group, 20% of patients were discharged home on an anti-arrhythmic medication compared to 47.1% in the control group. There were no adverse outcomes related to the application of Amiodarone Hydrogel.
CONCLUSION


In this small pilot study, the intra-operative application of Amiodarone-containing hydrogel to the pulmonary vein anastomoses and atria appeared to decrease the rates of POAF when compared to historical controls from the same institution.",2020,"There were no adverse outcomes related to the application of Amiodarone Hydrogel.
","['Post Lung Transplant Atrial Fibrillation', 'Twenty patients undergoing LTx at a single institution']","['Amiodarone-containing hydrogel', 'topical amiodarone', 'Amiodarone-Releasing Hydrogel', 'Amiodarone']","['POAF', 'cardioversion', 'discharged home on an anti-arrhythmic medication', 'development of POAF', 'rates of POAF']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",20.0,0.0282045,"There were no adverse outcomes related to the application of Amiodarone Hydrogel.
","[{'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Whited', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Trivedi', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}, {'ForeName': 'V H', 'Initials': 'VH', 'LastName': 'van Berkel', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1112']
2734,32464974,"INSPIRE: Final Results from a Phase 3, Open-Label, Pivotal Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension.","OF OBJECTIVES


Significant advantages are associated with inhaled therapies for pulmonary arterial hypertension (PAH), including enhanced delivery of drug to the lungs at a lower overall dose, improved ventilation-perfusion matching, and decreased risk of systemic vasodilation and other systemic adverse effects. LIQ861 is an investigational, novel, dry-powder formulation of treprostinil (TRE) designed using PRINT® technology to enhance deep-lung drug deposition and enable delivery of TRE doses in 1 to 2 breaths per capsule 4 times per day while using a convenient dry-powder inhaler. The primary objective of the INSPIRE study is to evaluate the safety and tolerability of LIQ861 in PAH patients transitioning to LIQ861 from a stable dose of Tyvaso® (Transition Group) and those adding LIQ861 to therapy with ≤2 non-prostacyclin (PGI) oral agents (Add-on Group). Final results from INSPIRE will be presented.
METHODS


INSPIRE is a phase 3, open-label, multicenter study that enrolled WHO Group I PAH patients classified as New York Heart Association (NYHA) functional class (FC) II-IV. Patients in the Transition Group received an initial dose of LIQ861 that was believed to be comparable to their Tyvaso® dose, while those in the Add-on Group initiated LIQ861 at a dose of 25 mcg capsule strength QID. LIQ861 dose increases in both groups were titrated in 25 mcg capsule strength QID increments to tolerance and symptom relief.
ENDPOINTS


The primary endpoint is the incidence of treatment-emergent adverse events and serious adverse events at Month 2. Exploratory endpoints are changes from baseline through Month 2 in physician assessment of stability; six-minute walk distance; NYHA FC, N-terminal B-type natriuretic peptide levels; and patient-reported quality of life. An additional endpoint for the Transition Group is the proportion of patients maintaining a sustained transition through Month 2, with sustained transition defined as continued LIQ861 therapy after discontinuation of Tyvaso®, no interruptions in LIQ861 therapy for ≥7 days; and no treatment with any other PGI analog or PGI receptor agonist.",2020,"Exploratory endpoints are changes from baseline through Month 2 in physician assessment of stability; six-minute walk distance; NYHA FC, N-terminal B-type natriuretic peptide levels; and patient-reported quality of life.","['pulmonary arterial hypertension (PAH', 'enrolled WHO Group I PAH patients classified as New York Heart Association (NYHA) functional class (FC) II-IV', 'PAH patients transitioning to LIQ861 from a stable dose of Tyvaso® (Transition Group) and those adding']","['INSPIRE', 'treprostinil (TRE', 'LIQ861', 'LIQ861 to therapy with ≤2 non-prostacyclin (PGI) oral agents']","['tolerance and symptom relief', 'physician assessment of stability; six-minute walk distance; NYHA FC, N-terminal B-type natriuretic peptide levels; and patient-reported quality of life', 'safety and tolerability', 'incidence of treatment-emergent adverse events and serious adverse events', 'Safety and Tolerability']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2718336', 'cui_str': 'Tyvaso'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0349743,"Exploratory endpoints are changes from baseline through Month 2 in physician assessment of stability; six-minute walk distance; NYHA FC, N-terminal B-type natriuretic peptide levels; and patient-reported quality of life.","[{'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Hill', 'Affiliation': 'Pulmonary, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Feldman', 'Affiliation': 'Arizona Pulmonary Specialists, Phoenix, AZ.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sahay', 'Affiliation': 'Houston Methodist Hospital, Houston, TX.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Levine', 'Affiliation': 'University of Texas Health Sciences Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Roscigno', 'Affiliation': 'Liquidia Technologies, Morrisville, NC.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Vaughn', 'Affiliation': 'Liquidia Technologies, Morrisville, NC.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Bull', 'Affiliation': 'Anschutz Medical Campus, University of Colorado Denver, Aurora, CO.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1142']
2735,32464995,Engineered Mesenchymal Stromal Cell Therapy during Human Lung Ex Vivo Lung Perfusion is Affected by Lung Acidosis.,"PURPOSE


Ex Vivo Lung Perfusion (EVLP) is an excellent platform to apply novel therapies for lung repair, perioperative protection and immunomodulation. In our previous large animal EVLP studies, we have combined gene and cell therapies, and used mesenchymal stromal cells genetically engineered to produce anti-inflammatory IL-10 (MSC IL10  cells) for lung protection. We investigated MSC IL10  therapy during EVLP in human rejected lungs as a translational step towards clinical applications.
METHODS


Pairs of human lungs rejected from clinical transplantation (n=4) were split, connected to single-lung EVLP circuits for 12 hours and randomly assigned to control or MSC IL10  groups. 40 × 10 6  cryopreserved MSC IL10  were administered through the pulmonary artery 1 hour after EVLP start. Perfusate IL-10 levels were measured by ELISA. The effect of the metabolic environment on MSC IL10  cell IL-10 production was studied in vitro by exposing MSC IL10  cells to perfusate samples with varying metabolic conditions, and by selectively altering pH and glucose.
RESULTS


MSC IL10  cells were rapidly retained in the lung (Fig A) and elevated EVLP perfusate IL-10 levels in minutes (Fig B). In contrast to our previous pig studies, perfusate IL-10 levels declined after 4-6 hours (Fig B) particularly in lungs with low perfusate pH and glucose, and high lactate. Exposing MSC IL10  cells to perfusate samples with poor metabolic conditions in vitro negatively affected IL-10 production. Acidosis profoundly decreased IL-10 production (Fig C) whereas glucose did not have a significant effect (Fig D).
CONCLUSION


MSC IL10  therapy rapidly increased perfusate IL-10 levels during human lung EVLP but was negatively affected by acidosis present in damaged lungs. Future studies will determine MSC IL10  effects on lung function and immunomodulation. The results imply that cell-based therapies are affected by target tissue acidosis, and that restoring metabolic conditions may optimize the effect of biologic therapies in damaged lungs.",2020,"Acidosis profoundly decreased IL-10 production (Fig C) whereas glucose did not have a significant effect (Fig D).
",['Pairs of human lungs rejected from clinical transplantation (n=4'],"['control or MSC IL10  groups', 'Engineered Mesenchymal Stromal Cell Therapy', 'Ex Vivo Lung Perfusion (EVLP']","['IL-10 production', 'elevated EVLP perfusate IL-10 levels', 'perfusate IL-10 levels', 'Perfusate IL-10 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4319517', 'cui_str': 'Order rejected'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",4.0,0.0615565,"Acidosis profoundly decreased IL-10 production (Fig C) whereas glucose did not have a significant effect (Fig D).
","[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Nykanen', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mariscal', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Estrada', 'Affiliation': 'Tissue Regeneration Therapeutics, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sage', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gokhale', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Donahoe', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yasufuku', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Waddell', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martinu', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juvet', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.753']
2736,31525174,The Triaxial Physical Activity Signature Associated with Metabolic Health in Children.,"PURPOSE


The use of uniaxial summary measures from accelerometry (i.e., counts per minute or minutes spent in moderate-to-vigorous intensity) substantially restricts information about physical activity (PA), and is probably a result of reliance on analytic approaches that cannot handle collinear variables. In the present study, we aimed to determine the multivariate triaxial PA intensity signature related to metabolic health in children, by investigating associations of the whole spectra of PA intensities from all axes using multivariate pattern analysis.
METHODS


We included 841 children (age, 10.2 ± 0.3 yr; body mass index, 18.0 ± 3.0; 50% boys) from the Active Smarter Kids study conducted in Norway 2014 to 2015 providing valid data on accelerometry (ActiGraph GT3X+) and several indices of metabolic health (aerobic fitness, abdominal fatness, insulin sensitivity, lipid metabolism, blood pressure) that were used to create a composite metabolic health score. We created intensity spectra from 0 to 100 to ≥10,000 counts per minute for separate axes and used multivariate pattern analysis to analyze the data.
RESULTS


The explained variance of metabolic health was 3.2% for counts per minute from the vertical axis, 17.0% for the vertical axis intensity spectrum, and 29.5% for the full model including all axes. Thus, including full triaxial intensity spectra improved the model for metabolic health tenfold compared with using overall PA (counts per minute) from the vertical axis only. The intensity signature associated with metabolic health differed across the axes.
CONCLUSIONS


Our findings show that the three different axes carry distinct information about children's PA and the relation of PA to their health and demonstrate a great potential for triaxial accelerometry and a multivariate analytic approach to advance the field of PA epidemiology.",2019,"The explained variance of metabolic health was 3.2% for counts per minute from the vertical axis, 17.0% for the vertical axis intensity spectrum, and 29.5% for the full model including all axes.","['841 children (age, 10.2 ± 0.3 yr; body mass index, 18.0 ± 3.0; 50% boys) from the Active Smarter Kids study conducted in Norway 2014 to 2015 providing', 'Children']",['valid data on accelerometry (ActiGraph GT3X'],"['Triaxial Physical Activity Signature', 'metabolic health (aerobic fitness, abdominal fatness, insulin sensitivity, lipid metabolism, blood pressure', 'metabolic health']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0441677', 'cui_str': 'Accelerometry'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",841.0,0.0574083,"The explained variance of metabolic health was 3.2% for counts per minute from the vertical axis, 17.0% for the vertical axis intensity spectrum, and 29.5% for the full model including all axes.","[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Aadland', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, NORWAY.'}, {'ForeName': 'Olav Martin', 'Initials': 'OM', 'LastName': 'Kvalheim', 'Affiliation': 'Department of Chemistry, University of Bergen, Bergen, NORWAY.'}, {'ForeName': 'Sigmund Alfred', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, NORWAY.'}, {'ForeName': 'Geir Kåre', 'Initials': 'GK', 'LastName': 'Resaland', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, NORWAY.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, NORWAY.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002021']
2737,31542384,"Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial.","BACKGROUND


Levoketoconazole is a ketoconazole stereoisomer in development for treatment of Cushing's syndrome and has not been assessed previously in a clinical trial in patients with Cushing's syndrome. We aimed to investigate the efficacy and safety of levoketoconazole in patients with endogenous Cushing's syndrome.
METHODS


SONICS is a phase 3, multicentre, open-label, non-randomised, single-arm study in which we recruited adults (≥18 years) with confirmed Cushing's syndrome and a mean 24-h urinary free cortisol (mUFC) of at least 1·5 times the upper limit of normal from 60 hospital and community sites in 19 countries (15 countries in Europe, and Canada, Israel, Turkey, and the USA). Patients were treated with oral levoketoconazole in a 2-21 week incremental dose-titration phase starting at 150 mg twice daily (150 mg increments until mUFC normalisation, maximum 600 mg twice daily) and a 6-month maintenance phase. The primary outcome was the proportion of patients with mUFC normalisation at end of maintenance, without dose increase during the maintenance phase (in the intention-to-treat population). Prespecified adverse events of special interest were potential liver toxicity, corrected QT prolongation, and adrenal insufficiency. This trial is registered with ClinicalTrials.gov, NCT01838551.
FINDINGS


Between July 30, 2014, and June 30, 2017, 201 individuals were screened and 94 patients were enrolled and received at least one dose of study medication. Of the 94 patients, 80 (85%) had pituitary Cushing's syndrome. Mean mUFC at baseline was 671·4 nmol/24 h (243·3 μg/24 h), which is 4·9 times the upper limit of normal. Of the 77 patients who advanced to the maintenance phase, 62 (81%) had mUFC normalisation by end-of-dose titration. At the end of the 6-month maintenance phase, 29 (31%) of 94 patients were responders; the least-squares mean estimate of the proportion of responders was 0·30 (95% CI 0·21-0·40; p=0·0154 vs null hypothesis of ≤0·20). The most common adverse events in the 94 patients were nausea (30 [32%]) and headache (26 [28%]). Adverse events led to study discontinuation in 12 (13%) of 94 patients. Two patients had a QT interval (Fridericia corrected) of more than 500 ms, and three patients had suspected adrenal insufficiency. Alanine aminotransferase reversibly increased to more than three times the upper limit of normal in ten (11%) patients. Four patients had serious adverse events that were considered probably or definitely related to the study drug: abnormal liver function test results (n=1), prolonged QT interval (n=2), and adrenal insufficiency (n=1). One person died from colon carcinoma unrelated to study medication.
INTERPRETATION


Twice-daily oral levoketoconazole treatment led to sustained improvements in urinary free cortisol, with an acceptable safety and tolerability profile. Levoketoconazole might represent a useful therapeutic option for the medical treatment of Cushing's syndrome.
FUNDING


Strongbridge Biopharma.",2019,"Four patients had serious adverse events that were considered probably or definitely related to the study drug: abnormal liver function test results (n=1), prolonged QT interval (n=2), and adrenal insufficiency (n=1).","[""recruited adults (≥18 years) with confirmed Cushing's syndrome and a mean 24-h urinary free cortisol (mUFC) of at least 1·5 times the upper limit of normal from 60 hospital and community sites in 19 countries (15 countries in Europe, and Canada, Israel, Turkey, and the USA"", ""94 patients, 80 (85%) had pituitary Cushing's syndrome"", 'Between July 30, 2014, and June 30, 2017, 201 individuals were screened and 94 patients were enrolled and received at least one dose of study medication', ""patients with endogenous Cushing's syndrome"", ""patients with Cushing's syndrome"", '77 patients who advanced to the maintenance phase, 62 (81%) had', ""endogenous Cushing's syndrome (SONICS""]","['oral levoketoconazole', 'levoketoconazole', 'Levoketoconazole']","['headache', 'acceptable safety and tolerability profile', 'QT interval (Fridericia corrected', 'potential liver toxicity, corrected QT prolongation, and adrenal insufficiency', 'Alanine aminotransferase', 'Mean mUFC', 'proportion of patients with mUFC normalisation', 'Efficacy and safety', 'efficacy and safety', 'serious adverse events', 'suspected adrenal insufficiency', 'nausea', 'mUFC normalisation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",201.0,0.0885122,"Four patients had serious adverse events that were considered probably or definitely related to the study drug: abnormal liver function test results (n=1), prolonged QT interval (n=2), and adrenal insufficiency (n=1).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Department of Medicine and Neurological Surgery, Northwest Pituitary Center, Oregon Health & Science University, Portland, OR, USA. Electronic address: fleseriu@ohsu.edu.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università di Napoli Federico II, Naples, Italy.'}, {'ForeName': 'Atanaska', 'Initials': 'A', 'LastName': 'Elenkova', 'Affiliation': 'Department of Endocrinology, Medical University Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvatori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism and Pituitary Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Auchus', 'Affiliation': 'Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Eliza B', 'Initials': 'EB', 'LastName': 'Geer', 'Affiliation': 'Pituitary & Skull Base Tumor Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yona', 'Initials': 'Y', 'LastName': 'Greenman', 'Affiliation': 'Institute of Endocrinology and Metabolism, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Witek', 'Affiliation': 'Department of Gastroenterology, Endocrinology and Internal Diseases, Military Institute of Medicine, Warsaw, Poland.'}, {'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Cohen', 'Affiliation': 'Strongbridge Biopharma, Trevose, PA, USA.'}, {'ForeName': 'Beverly M K', 'Initials': 'BMK', 'LastName': 'Biller', 'Affiliation': 'Neuroendocrine Clinical Center, Massachusetts General Hospital, Boston, MA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30313-4']
2738,32462037,Effects of Cardiac Sympathetic Neurodegeneration and PPAR γ  Activation on Rhesus Macaque Whole Blood miRNA and mRNA Expression Profiles.,"Degeneration of sympathetic innervation of the heart occurs in numerous diseases, including diabetes, idiopathic REM sleep disorder, and Parkinson's disease (PD). In PD, cardiac sympathetic denervation occurs in 80-90% of patients and can begin before the onset of motor symptoms. Today, there are no disease-modifying therapies for cardiac sympathetic neurodegeneration, and biomarkers are limited to radioimaging techniques. Analysis of expression levels of coding mRNA and noncoding RNAs, such as microRNAs (miRNAs), can uncover pathways involved in disease, leading to the discovery of biomarkers, pathological mechanisms, and potential drug targets. Whole blood in particular is a clinically relevant source of biomarkers, as blood sampling is inexpensive and simple to perform. Our research group has previously developed a nonhuman primate model of cardiac sympathetic denervation by intravenous administration of the catecholaminergic neurotoxin 6-hydroxydopamine (6-OHDA). In this rhesus macaque ( Macaca mulatta ) model, imaging with positron emission tomography showed that oral administration of the peroxisome proliferator-activated receptor gamma (PPAR γ ) agonist pioglitazone ( n  = 5; 5 mg/kg daily) significantly decreased cardiac inflammation and oxidative stress compared to placebo ( n  = 5). Here, we report our analysis of miRNA and mRNA expression levels over time in the whole blood of these monkeys. Differential expression of three miRNAs was induced by 6-OHDA (mml-miR-16-2-3p, mml-miR-133d-3p, and mml-miR-1262-5p) and two miRNAs by pioglitazone (mml-miR-204-5p and mml-miR-146b-5p) at 12 weeks posttoxin, while expression of mRNAs involved in inflammatory cytokines and receptors was not significantly affected. Overall, this study contributes to the characterization of rhesus coding and noncoding RNA profiles in normal and disease-like conditions, which may facilitate the identification and clinical translation of biomarkers of cardiac neurodegeneration and neuroprotection.",2020,"Differential expression of three miRNAs was induced by 6-OHDA (mml-miR-16-2-3p, mml-miR-133d-3p, and mml-miR-1262-5p) and two miRNAs by pioglitazone (mml-miR-204-5p and mml-miR-146b-5p) at 12 weeks posttoxin, while expression of mRNAs involved in inflammatory cytokines and receptors was not significantly affected.",[],"['pioglitazone', 'catecholaminergic neurotoxin 6-hydroxydopamine', 'placebo']",['cardiac inflammation and oxidative stress'],[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0027934', 'cui_str': 'Neurotoxin'}, {'cui': 'C0085196', 'cui_str': '6-Hydroxydopamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.0452675,"Differential expression of three miRNAs was induced by 6-OHDA (mml-miR-16-2-3p, mml-miR-133d-3p, and mml-miR-1262-5p) and two miRNAs by pioglitazone (mml-miR-204-5p and mml-miR-146b-5p) at 12 weeks posttoxin, while expression of mRNAs involved in inflammatory cytokines and receptors was not significantly affected.","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Metzger', 'Affiliation': ""Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center, University of Wisconsin-Madison, Madison, 53706 WI, USA.""}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Lopez', 'Affiliation': 'Cellular and Molecular Pathology Graduate Program, University of Wisconsin-Madison, Madison, 53706 WI, USA.'}, {'ForeName': 'Jenna K', 'Initials': 'JK', 'LastName': 'Schmidt', 'Affiliation': ""Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center, University of Wisconsin-Madison, Madison, 53706 WI, USA.""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Murphy', 'Affiliation': ""Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center, University of Wisconsin-Madison, Madison, 53706 WI, USA.""}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Vemuganti', 'Affiliation': 'Cellular and Molecular Pathology Graduate Program, University of Wisconsin-Madison, Madison, 53706 WI, USA.'}, {'ForeName': 'Marina E', 'Initials': 'ME', 'LastName': 'Emborg', 'Affiliation': ""Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center, University of Wisconsin-Madison, Madison, 53706 WI, USA.""}]",BioMed research international,['10.1155/2020/9426204']
2739,32462049,"Post Hoc Assessment of Time to Clinical Response Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials.","Time to clinical response, a proxy for hospital ""discharge readiness,"" was compared between CABP inpatients who received lefamulin or moxifloxacin in the Lefamulin Evaluation Against Pneumonia (LEAP) trials. The analysis included 926 inpatients. A short and comparable median time to clinical response (4 days) was observed in both treatment groups.",2020,A short and comparable median time to clinical response (4 days) was observed in both treatment groups.,"['926 inpatients', 'Adults Hospitalized with Community-Acquired Bacterial Pneumonia']","['Lefamulin or Moxifloxacin', 'lefamulin or moxifloxacin']",['median time to clinical response'],"[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",926.0,0.291308,A short and comparable median time to clinical response (4 days) was observed in both treatment groups.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, New York, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Market Access Services Inc., Gaithersburg, Maryland, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Stein', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitts', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Scoble', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schranz', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa145']
2740,32462056,Assessment of baseline bone turnover marker levels and response to risedronate treatment: Data from a Japanese phase III trial.,"Background


Risedronate increases bone mineral density (BMD) and reduces fracture risk, but treatment response may depend on the baseline state of bone turnover. Data regarding the selection of therapeutic drugs or the prediction of therapeutic effects with baseline levels of bone turnover markers (BTMs) as a reference are insufficient. We hypothesized that when the baseline levels of BTMs are higher, baseline BMD might be lower, changes in BMD at 12 months after risedronate treatment might be higher, and the reduction of fracture incidence might be greater. This study aimed to analyze the data of a phase III clinical trial of risedronate from Japan to investigate the relationships between baseline BTM levels and (1) baseline BMD, (2) changes in BMD at 12 months after the start of treatment, and (3) the incidence of new vertebral fractures.
Methods


This post-hoc analysis included 788 postmenopausal women with osteoporosis whose baseline BTM levels as well as baseline and endpoint BMDs were measured. Relationships between baseline BTM levels and BMD at baseline and 12 months after risedronate treatment and new vertebral fractures were examined. One-way analysis of variance, two-tailed Student's  t -test, and Fisher's exact test were used to analyze the data.
Results


Baseline BMD showed a significant upward trend when baseline BTM levels were lower in the analysis by tertiles. New vertebral fractures tended to occur in patients with prevalent vertebral fractures, but the relationship between new fractures and BTM levels was not statistically significant. Regardless of BTM types, BMD percentage increments (%) and increments (g/cm 2 ) with the 12-month treatment were high when pretreatment BTM levels were high (P < 0.0001), and a >5.0% increase in BMD was observed even if baseline BTM levels were within the normal range. A new vertebral fracture occurred in only six patients (0.77%), and there was not enough statistical power to clarify the relationship between baseline BTM levels and fracture risk reduction.
Conclusions


When pretreatment BTM levels increased, baseline BMD tended to be lower and the increase in BMD with 12-month risedronate treatment was higher. However, BMD could still be increased even if the baseline BTM levels are within the normal range. Combined with available evidence, baseline BTMs may not have an important role in deciding the optimal therapy. To elucidate the relationship between baseline BTM levels and long-term fracture risk, it will be necessary to conduct more large-scale studies with a longer follow-up period in severe osteoporotic patients with a high fracture risk.
Mini abstract


We evaluated the significance of baseline bone turnover markers in the response to risedronate treatment. The increase in the bone mineral density (BMD) with the 12-month treatment may be higher when the state of bone turnover at baseline is higher, and BMD could still be increased even if the baseline bone turnover is within the normal range.",2020,"A new vertebral fracture occurred in only six patients (0.77%), and there was not enough statistical power to clarify the relationship between baseline BTM levels and fracture risk reduction.
","['788 postmenopausal women with osteoporosis', 'severe osteoporotic patients with a high fracture risk']","['Mini abstract', 'risedronate', '\n\n\nRisedronate']","['baseline BTM levels and BMD', 'vertebral fracture', 'baseline BMD', 'BMD', 'baseline BTM levels', 'bone mineral density (BMD', 'bone mineral density (BMD) and reduces fracture risk', 'baseline BTM levels and (1) baseline BMD, (2) changes in BMD', 'BTM levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",788.0,0.06562,"A new vertebral fracture occurred in only six patients (0.77%), and there was not enough statistical power to clarify the relationship between baseline BTM levels and fracture risk reduction.
","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Mawatari', 'Affiliation': 'Department of Orthopedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikemura', 'Affiliation': 'Department of Orthopedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Matsui', 'Affiliation': 'Department of Orthopedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Department of Orthopedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Mitsuyasu', 'Affiliation': 'Department of Orthopedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kawahara', 'Affiliation': 'Department of Orthopedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Maehara', 'Affiliation': 'Alliance Management Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Muraoka', 'Affiliation': 'Data Science Group, Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Orthopedic Surgery, Kyushu Rosai Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuharu', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Orthopedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]",Bone reports,['10.1016/j.bonr.2020.100275']
2741,32462104,"""It Gave Me Hope"" Experiences of Diverse Safety Net Patients in a Group Acupuncture Intervention for Painful Diabetic Neuropathy.","Purpose:  To explore the experiences of living with painful diabetic neuropathy (PDN) and with a group acupuncture intervention in a sample of low-income, diverse patients.  Methods:  We conducted a randomized clinical trial of a 12-week group acupuncture intervention for PDN. Data included validated measures of patient-reported outcomes, including pain and quality of life (QOL), as well as semistructured qualitative interviews about participants' experiences with PDN and the intervention. Interview transcripts were coded and analyzed using an inductive thematic framework.  Results:  We recruited 40 participants from diverse racial/ethnic backgrounds from a public hospital and conducted in-depth qualitative interviews with a subset of 17 participants. Participants randomized to acupuncture experienced greater decreases in pain compared with usual care as well as improved QOL. In interviews, they described a myriad of socioeconomic and personal life stressors that compounded the significant suffering and disability brought on by PDN. Those who received acupuncture were able to decrease reliance on pain medication, improve their sleep and daily function, reduce stress, and engage more with their own self-care. They noted that the acupuncture intervention also gave them hope in the face of their chronic disease.  Conclusion:  Acupuncture is a valuable adjunct treatment for low-income and marginalized populations with PDN. In addition to reducing pain and improving QOL, acupuncture may offer powerful benefits by increasing patient activation and hope.",2020,"Those who received acupuncture were able to decrease reliance on pain medication, improve their sleep and daily function, reduce stress, and engage more with their own self-care.",['40 participants from diverse racial/ethnic backgrounds from a public hospital and conducted in-depth qualitative interviews with a subset of 17 participants'],"['Acupuncture Intervention', 'acupuncture intervention', 'acupuncture', 'Acupuncture']","['QOL', 'pain', 'pain medication, improve their sleep and daily function, reduce stress, and engage more with their own self-care', 'pain and quality of life (QOL']","[{'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]",40.0,0.126128,"Those who received acupuncture were able to decrease reliance on pain medication, improve their sleep and daily function, reduce stress, and engage more with their own self-care.","[{'ForeName': 'Rhianon', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Trilce', 'Initials': 'T', 'LastName': 'Santana', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Chao', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, UCSF, San Francisco, California, USA.'}]",Health equity,['10.1089/heq.2020.0004']
2742,32462111,Assessing Full Benefit of Rivaroxaban Prophylaxis in High-Risk Ambulatory Patients with Cancer: Thromboembolic Events in the Randomized CASSINI Trial.,"Introduction   In the CASSINI study, rivaroxaban thromboprophylaxis significantly reduced primary venous thromboembolism (VTE) endpoints during the intervention period, but several thromboembolic events designated as secondary efficacy endpoints were not included in the primary analysis. This study was aimed to evaluate the full impact of rivaroxaban thromboprophylaxis on all prespecified thromboembolic endpoints occurring on study.  Methods   CASSINI was a double-blind, randomized, placebo-controlled study in adult ambulatory patients with cancer at risk for VTE (Khorana score ≥2). Patients were screened at baseline for deep-vein thrombosis (DVT) and randomized if none was found. The primary efficacy endpoint was a composite of lower extremity proximal DVT, symptomatic upper extremity, or lower extremity distal DVT, any pulmonary embolism, and VTE-related death. This analysis evaluated all prespecified thromboembolic endpoints occurring on study to determine the full benefit of rivaroxaban prophylaxis. All endpoints were independently adjudicated.  Results   Total thromboembolic events occurred in fewer patients randomized to rivaroxaban during the full study period (29/420 [6.9%] and 49/421 [11.6%] patients in rivaroxaban and placebo groups, respectively [hazard ratio (HR) = 0.57; 95% confidence interval (CI): 0.36-0.90;  p   = 0.01]; number needed to treat [NNT] = 21). Similarly, fewer patients randomized to rivaroxaban experienced thromboembolism during the intervention period (13/420 [3.1%] patients) versus placebo (38/421 [9.0%] patients; HR = 0.33; 95% CI: 0.18-0.62;  p  < 0.001; NNT = 17).  Conclusion   Our findings confirm the substantial benefit of rivaroxaban thromboprophylaxis when considering all prespecified thromboembolic events, even after excluding baseline screen-detected DVT. The low NNT, coupled with prior data demonstrating a high number needed to harm, should assist clinicians in determining the risk/benefit of thromboprophylaxis in high-risk patients with cancer.",2020,"In the CASSINI study, rivaroxaban thromboprophylaxis significantly reduced primary venous thromboembolism (VTE) endpoints during the intervention period, but several thromboembolic events designated as secondary efficacy endpoints were not included in the primary analysis.","['adult ambulatory patients with cancer at risk for VTE ', 'high-risk patients with cancer', 'High-Risk Ambulatory Patients with Cancer']","['rivaroxaban prophylaxis', 'Rivaroxaban Prophylaxis', 'rivaroxaban thromboprophylaxis', 'rivaroxaban', 'placebo']","['primary venous thromboembolism (VTE) endpoints', 'thromboembolism', 'Total thromboembolic events', 'Thromboembolic Events', 'composite of lower extremity proximal DVT, symptomatic upper extremity, or lower extremity distal DVT, any pulmonary embolism, and VTE-related death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.422716,"In the CASSINI study, rivaroxaban thromboprophylaxis significantly reduced primary venous thromboembolism (VTE) endpoints during the intervention period, but several thromboembolic events designated as secondary efficacy endpoints were not included in the primary analysis.","[{'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, United States.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Division of Cancer Sciences, Department of Medical Oncology, University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Kakkar', 'Affiliation': 'Thrombosis Research Institute and University College London, London, United Kingdom.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Streiff', 'Affiliation': 'Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Department of Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Raritan, New Jersey, United States.'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'Medical Affairs Internal Medicine, Janssen Scientific Affairs, LLC, Titusville, New Jersey, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'Medical Affairs Internal Medicine, Janssen Scientific Affairs, LLC, Titusville, New Jersey, United States.'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'Hematology Service, Memorial Sloan Kettering Cancer Center, New York, New York, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",TH open : companion journal to thrombosis and haemostasis,['10.1055/s-0040-1712143']
2743,32462119,Rebound of HBV DNA after cessation of nucleos/tide analogues in chronic hepatitis B patients with undetectable covalently closed.,"Background & Aims


Nucleos(t)ide analogues (NUCs) effectively suppress serum HBV DNA. Previously, we have identified 21 patients with undetectable covalently closed circular DNA (cccDNA) upon long-term NUC therapy. This study investigated the effect of NUC withdrawal in patients with undetectable cccDNA.
Methods


Nineteen patients on long term NUCs (median 13.4 years) were recruited: 13 were randomized to discontinue NUCs; 6 to continue taking NUCs. All had undetectable cccDNA at the time of last liver biopsy (median time 2.9 years prior to randomization). Serum HBV DNA, hepatitis B surface antigen (HBsAg), hepatitis B core-related antigen (HBcrAg), liver biochemistry, and serum HBV RNA were monitored.
Results


At the time of randomization, all patients had undetectable serum HBV DNA and HBV RNA. Twelve of the 13 patients had HBV DNA rebound to 100 IU/ml within 20 weeks of NUC discontinuation. The thirteenth patient had HBV DNA rebound at week 70. Three patients experienced biochemical flares after re-treatment which subsequently resolved. There was no significant association between the time of HBV DNA rebound and baseline HBsAg, HBcrAg and alanine aminotransferase, duration of treatment, and age at which treatment was stopped (all  p  >0.05). At the time of HBV DNA rebound, HBV DNA levels correlated with HBcrAg levels ( p  = 0.003), but not with HBsAg levels ( p  = 0.262).
Conclusions


In patients with undetectable intrahepatic cccDNA, virologic rebound still occurred after NUC cessation. At the rebound of HBV DNA, the kinetics of HBsAg production were independent of those of viral DNA replication. Additional studies are required to determine the factors that may predict virologic rebound and when NUCs can be discontinued in HBsAg-positive patients with chronic hepatitis B.
Lay summary


It has been shown that following long-term nucleos(t)ide analogue treatment for chronic hepatitis B, some patients have undetectable levels of viral DNA in their livers. We tested the results of withdrawing nucleos(t)ide analogue treatment in these patients and found that viral relapse could occur in patients with undetectable viral DNA. Further research is required to determine whether nucleos(t)ide analogue treatment can be discontinued in specific patients with chronic hepatitis B.",2020,"There was no significant association between the time of HBV DNA rebound and baseline HBsAg, HBcrAg and alanine aminotransferase, duration of treatment, and age at which treatment was stopped (all  p  >0.05).","['specific patients with chronic hepatitis B', 'chronic hepatitis B patients with undetectable covalently closed', 'Nineteen patients on long term NUCs (median 13.4 years) were recruited: 13', '21 patients with undetectable covalently closed circular DNA (cccDNA) upon long-term NUC therapy', 'patients with undetectable cccDNA', 'HBsAg-positive patients with chronic hepatitis B']",['discontinue NUCs'],"['time of HBV DNA rebound and baseline HBsAg, HBcrAg and alanine aminotransferase, duration of treatment, and age at which treatment', 'time of HBV DNA rebound, HBV DNA levels', 'undetectable serum HBV DNA and HBV RNA', 'virologic rebound still', 'HBsAg levels', 'biochemical flares', 'Serum HBV DNA, hepatitis B surface antigen (HBsAg), hepatitis B core-related antigen (HBcrAg), liver biochemistry, and serum HBV RNA', 'viral relapse', 'kinetics of HBsAg production']","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012925', 'cui_str': 'Circular DNA'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0149709', 'cui_str': 'Hepatitis B surface antigen positive'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.0230747,"There was no significant association between the time of HBV DNA rebound and baseline HBsAg, HBcrAg and alanine aminotransferase, duration of treatment, and age at which treatment was stopped (all  p  >0.05).","[{'ForeName': 'Ching-Lung', 'Initials': 'CL', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Danny Ka-Ho', 'Initials': 'DK', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Gerald Tsz-Yau', 'Initials': 'GT', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}]",JHEP reports : innovation in hepatology,['10.1016/j.jhepr.2020.100112']
2744,32462131,A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.,"Background


Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.
Methods


The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multicentre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019). Participants were randomized (1:1:1) to 1 of 3 treatment arms: nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes. All groups received individual counselling. Treatment allocation was double-blind for the e-cigarette groups. The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. The primary endpoint is to compare nicotine e-cigarettes to counselling alone in terms of biochemically validated point-prevalence smoking abstinence at 12 weeks; the primary endpoint was changed from 52 weeks after early termination (77% of targeted enrollment) due to a prolonged delay in e-cigarette manufacturing. The secondary objectives are to examine the efficacy of nicotine and non-nicotine e-cigarettes in terms of point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption at all follow-ups through week 52, and to describe the occurrence of adverse events.
Conclusion


The E3 trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.",2020,"The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52.","['smokers who achieve long-term abstinence', '376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019']","['individual counselling', 'nicotine and non-nicotine e-cigarettes', '\n\n\nSmoking cessation', 'E-Cigarette Use', 'nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes']","['morbidity and mortality', 'nicotine e-cigarettes to counselling alone in terms of biochemically validated point-prevalence smoking abstinence', 'point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}]",376.0,0.0623095,"The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52.","[{'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Hébert-Losier', 'Affiliation': 'Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Kristian B', 'Initials': 'KB', 'LastName': 'Filion', 'Affiliation': 'Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Windle', 'Affiliation': 'Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Eisenberg', 'Affiliation': 'Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}]",CJC open,['10.1016/j.cjco.2020.03.006']
2745,32462206,"A Randomized, Double-Blind, Split-Body, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Tolerability of a Topical Body Firming Moisturizer for Upper Arm Rejuvenation.","BACKGROUND


Skin aging of upper arm, induced by intrinsic and extrinsic factors, often results in loss of contour, elasticity and firmness, and increase in laxity, crepiness, roughness and photodamage. A topical body firming moisturizer (TBFM) was developed to target all aspects of aged body skin.
OBJECTIVE


The aim of this study was to evaluate the efficacy and tolerability of the TBFM for upper arm firming and rejuvenation.
METHODS


Forty female subjects, 40-60 years old, Fitzpatrick skin type II-V, with mild to moderate laxity, crepiness, and photodamage on the upper arms were recruited into the study, 10 of whom were selected for biopsy analysis. Subjects were randomized to apply the TBFM and placebo moisturizer on the assigned arms twice daily for 12 weeks. At each visit, efficacy and tolerability evaluation, self-assessment, and standardized clinical photography were taken. Ultrasound measurements were performed at baseline, week 8 and week 12.
RESULTS


Results from the efficacy evaluation by the clinical grader and bio-instrumentation analysis showed the TBFM improved all skin parameters of the aged upper arm while outperforming the placebo moisturizer after 12 weeks. Clinical photography showed the test product was able to tone and firm the skin. The TBFM was well-tolerated and well-perceived by the subjects. Ultrasound images illustrated an improvement in skin density and skin structure at week 12.
CONCLUSION


This clinical trial positively supports the hypothesis that the TBFM was effective and tolerable in improving crepey, lax, and photodamaged skin of the upper arms after 12 weeks of treatment twice daily.",2020,"RESULTS


Results from the efficacy evaluation by the clinical grader and bio-instrumentation analysis showed the TBFM improved all skin parameters of the aged upper arm while outperforming the placebo moisturizer after 12 weeks.","['Forty female subjects, 40-60 years old, Fitzpatrick skin type II-V, with mild to moderate laxity, crepiness, and photodamage on the upper arms were recruited into the study, 10 of whom were selected for biopsy analysis']","['TBFM', 'Placebo', 'TBFM and placebo']","['efficacy and tolerability evaluation, self-assessment, and standardized clinical photography', 'Efficacy and Tolerability', 'effective and tolerable in improving crepey, lax, and photodamaged skin', 'skin density and skin structure', 'efficacy and tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0431056', 'cui_str': 'Photography of patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1123023', 'cui_str': 'Skin structure'}]",40.0,0.0450384,"RESULTS


Results from the efficacy evaluation by the clinical grader and bio-instrumentation analysis showed the TBFM improved all skin parameters of the aged upper arm while outperforming the placebo moisturizer after 12 weeks.","[{'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Kavali', 'Affiliation': ''}, {'ForeName': 'Thu Q', 'Initials': 'TQ', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Alisar S', 'Initials': 'AS', 'LastName': 'Zahr', 'Affiliation': ''}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kononov', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa134']
2746,32462740,Vitamin D supplementation for sickle cell disease.,"BACKGROUND


Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.
OBJECTIVES


To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.
SEARCH METHODS


We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.
SELECTION CRITERIA


Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.
MAIN RESULTS


Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose group, at one year, MD 0.27 (95% CI 0.02 to 0.52) but there was little or no difference at two years, MD 0.09 (95% CI -0.04 to 0.22) (moderate-quality evidence). At one year and two years there was also little or no difference between the doses in the presence of pain (moderate-quality evidence) or forced expiratory volume in one second % predicted. However, the high-dose group had lower values for % predicted forced vital capacity at both one and two years, MD -7.20% predicted (95% CI -14.15 to -0.25) and MD -7.10% predicted (95% CI -14.03 to -0.17), respectively. There were little or no differences between dose regimens in the muscle health of either hand or the dominant hand. The study comparing oral vitamin D3 7000 IU/day to 4000 IU/day (21 participants) did not provide data for analysis, but median serum 25(OH)D levels were reported to be lower in the low-dose group at both six and 12 weeks. At 12 weeks the median serum parathyroid hormone level was lower in the high-dose group.
AUTHORS' CONCLUSIONS


We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.",2020,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","['sickle cell disease', 'children and adults with SCD', 'people with SCD, of all ages, gender, and phenotypes']","['vitamin D. One RCT', 'vitamin D or placebo or no supplementation', 'Vitamin D supplementation', 'oral vitamin D3', 'vitamin D supplementation', 'oral vitamin D3 (cholecalciferol) supplementation', 'placebo']","['general health (e.g. growth status and health-related quality of life', 'musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections', 'forced vital capacity', 'pain days', 'episodes of acute chest syndrome', 'presence of pain (moderate-quality evidence) or forced expiratory volume', 'adverse events (tingling of lips or hands', 'lower (worse) health-related quality of life score', 'adverse events', 'median serum parathyroid hormone level', 'median serum 25(OH)D levels', 'serum 25(OH)D levels']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877487', 'cui_str': 'Tingling lips'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.658415,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","[{'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HHK', 'LastName': 'Soe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College, Manipal Academy of Higher Education (MAHE), Melaka, Malaysia.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College (Manipal Academy of Higher Education), Melaka, Malaysia.'}, {'ForeName': 'Nan Nitra', 'Initials': 'NN', 'LastName': 'Than', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College (MMMC), Manipal Academy of Higher Education(MAHE), Melaka, Malaysia.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Faculty of Medicine, SEGi University, Sibu, Malaysia.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Faculty of Medicine, Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Abdul Razzak Bin Mohd', 'Initials': 'ARBM', 'LastName': 'Said', 'Affiliation': 'Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Ifeyinwa', 'Initials': 'I', 'LastName': 'Osunkwo', 'Affiliation': 'Comprehensive Sickle Cell Program, Aflac Cancer and Blood Disorders Service, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010858.pub3']
2747,32462746,Impact of the sexual abstinence period on the production of seminal reactive oxygen species in patients undergoing intrauterine insemination: A randomized trial.,"AIM


To evaluate whether the duration of sexual abstinence has impact on oxidative stress in semen samples.
METHODS


Oxidative reaction was tested for different levels of reactive oxygen species (ROS) by nitro blue tetrazolium assay in 90 patients with the diagnosis of unexplained or male factor infertility that were grouped into 3 groups as 0-2 (group 1), 3-4 (group 2) and >4 days (group 3) of duration of sexual abstinence. Subsequently, the remaining semen was prepared by gradient method for ovarian stimulation and intrauterine insemination (IUI) cycles to compare pregnancy rates in terms of different levels of ROS and different abstinence periods.
RESULTS


Increased staining pigment intensity was related to higher level of ROS in >4 days' group as compared to groups 0-2 and 3-4 days (70% vs 43.3% and 50%, P = 0.013 and P = 0.014, respectively). Pregnancy rates significantly decrease with prolonged abstinence period (26.7%, 16.7% and 6.7% in groups 1, 2 and 3, respectively, P = 0.039). Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups.
CONCLUSION


Longer duration of sexual abstinence causes higher oxidative stress and decreases pregnancy rates in IUI cycles.",2020,"Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups.
","['90 patients with the diagnosis of unexplained or male factor infertility', 'patients undergoing intrauterine insemination', 'semen samples']",['reactive oxygen species (ROS) by nitro blue tetrazolium assay'],"['staining pigment intensity', 'Progressive motile sperm count', 'oxidative stress', 'pregnancy rates', 'level of ROS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0444176', 'cui_str': 'Seminal fluid specimen'}]","[{'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0430303', 'cui_str': 'Nitro Blue tetrazolium assay'}]","[{'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]",90.0,0.203675,"Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups.
","[{'ForeName': 'Yaman', 'Initials': 'Y', 'LastName': 'Degirmenci', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Demirdag', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Guler', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Yildiz', 'Affiliation': 'Department of Obstetrics and Gynecology, Koç University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14308']
2748,32462773,Zonisamide as an Adjunctive Treatment to Cognitive Processing Therapy for Veterans With Posttraumatic Stress Disorder and Comorbid Alcohol Use Disorder: A Pilot Study.,"BACKGROUND AND OBJECTIVES


There are high rates of comorbid alcohol use disorder (AUD) among those who have posttraumatic stress disorder (PTSD). Ideally, treatment for comorbidity should address both disorders simultaneously. Zonisamide, an anticonvulsant, may be effective in decreasing alcohol use and may attenuate symptoms of PTSD. Treatment strategies can include medication in combination with a proven evidence-based psychotherapy designed to treat PTSD, such as cognitive processing therapy (CPT).
METHODS


This 12-week pilot study was designed to test feasibility, acceptability, and preliminary efficacy of zonisamide (400 mg) as an adjunct to CPT for veterans with PTSD and comorbid AUD. Veterans (n = 24) with PTSD and current alcohol dependence were randomized in a 3:1 ratio to receive zonisamide or placebo in a double-blind fashion. All subjects received CPT enhanced to include sessions addressing drinking behavior.
RESULTS


Subjects overall reported a significant decrease in drinking outcomes, craving, and symptoms of PTSD. Zonisamide was well-tolerated and easily administered with CPT, which was also well-tolerated. Exploratory analysis of comparison of groups suggests there was no advantage of zonisamide vs placebo in drinking or PTSD outcomes. There was a numeric but nonsignificant higher rate of abstinence with zonisamide (50%) vs placebo (33%).
CONCLUSION AND SCIENTIFIC SIGNIFICANCE


The interpretation of the results is limited by the pilot nature of this study. The combination of psychosocial treatment with medication management mimics real-world treatment. In order to isolate the individual contributions of medication vs psychotherapy a much larger study would need to be conducted. (Am J Addict 2020;00:00-00).",2020,"There was a numeric but nonsignificant higher rate of abstinence with zonisamide (50%) vs placebo (33%).
","['Veterans With Posttraumatic Stress Disorder and Comorbid Alcohol Use Disorder', 'veterans with PTSD and comorbid AUD', 'Veterans (n\u2009=\u200924) with PTSD and current alcohol dependence']","['Cognitive Processing Therapy', 'Zonisamide', 'CPT', 'zonisamide', 'zonisamide or placebo', 'zonisamide vs placebo', 'placebo']","['rate of abstinence', 'drinking outcomes, craving, and symptoms of PTSD']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",,0.0220214,"There was a numeric but nonsignificant higher rate of abstinence with zonisamide (50%) vs placebo (33%).
","[{'ForeName': 'Ismene', 'Initials': 'I', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ralevski', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'DeNegre', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jenelle', 'Initials': 'J', 'LastName': 'Newcomb', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Gianoli', 'Affiliation': 'Department of Veterans Affairs, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'McCarthy', 'Affiliation': 'National Center for Posttraumatic Stress Disorder, White River Junction VA Medical Center, White River Junction, Vermont.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Meshberg-Cohen', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gihyun', 'Initials': 'G', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}]",The American journal on addictions,['10.1111/ajad.13061']
2749,32462950,"Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors.","Background:  Integrative oncology has proven to be a useful approach to control cancer symptoms and improve the quality of life (QoL) and overall health of patients, delivering integrated patient care at both physical and emotional levels. The objective of this randomized trial was to evaluate the effects of a triple intervention program on the QoL and lifestyle of women with breast cancer.  Methods:  Seventy-five survivors of stage IIA-IIB breast cancer were randomized into 2 groups. The intervention group (IG) received a 6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG). Data were gathered at baseline and at 6 months postintervention on QoL and adherence to Mediterranean diet using clinical markers and validated questionnaires. Between-group differences at baseline and 3 months postintervention were analyzed using Student's  t  test for related samples and the Wilcoxon and Mann-Whitney  U  tests.  Results:  At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p  = .027), role functioning ( p  = .028), and Mediterranean diet adherence ( p  = .02) and a significant reduction in body mass index ( p  = .04) and weight ( p  = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p  = .05). Dyspnea symptoms were also increased in the CG versus IG ( p  = .066).  Conclusions:  These results demonstrate that an integrative dietary, physical activity, and mindfulness program enhances the QoL and healthy lifestyle of stage IIA-IIB breast cancer survivors. Cancer symptoms may be better managed by the implementation of multimodal rather than isolated interventions.",2020,"At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p  = .027), role functioning ( p  = .028), and Mediterranean diet adherence ( p  = .02) and a significant reduction in body mass index ( p  = .04) and weight ( p  = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p  = .05).","['women with breast cancer', 'Methods:  Seventy-five survivors of stage IIA-IIB breast cancer', 'Stage IIA-IIB Breast Cancer Survivors']","['triple intervention program', '6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG', 'Multidisciplinary Program of Diet, Exercise, and Mindfulness']","['mean weight loss', 'body mass index', 'Mediterranean diet adherence', 'quality of life (QoL) and overall health', 'physical functioning', 'role functioning', 'Dyspnea symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1444651', 'cui_str': 'Not offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0282137,"At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p  = .027), role functioning ( p  = .028), and Mediterranean diet adherence ( p  = .02) and a significant reduction in body mass index ( p  = .04) and weight ( p  = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p  = .05).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ruiz-Vozmediano', 'Affiliation': '""Virgen de las Nieves"" University Hospital, Granada, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Löhnchen', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado', 'Affiliation': 'Mixed University Sport and Health Institute, Granada, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Recio', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rodríguez-Carrillo', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Mustieles', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Expósito', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Fernández', 'Affiliation': 'University of Granada, Granada, Spain.'}]",Integrative cancer therapies,['10.1177/1534735420924757']
2750,32462958,Cost-effectiveness analysis of pembrolizumab monotherapy versus chemotherapy for previously untreated advanced non-small cell lung cancer.,"OBJECTIVE


To assess the cost-effectiveness of pembrolizumab monotherapy compared with standard chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in previously untreated adults who have a high programmed death ligand 1 (PD-L1) tumor proportion score of 50% or greater in Singapore.
MATERIALS AND METHODS


A partitioned-survival analysis model was developed from a healthcare system's perspective that extrapolated clinical and economic outcomes of first-line pembrolizumab (maximum treatment duration of 2 years) versus platinum doublet chemotherapy over a 10-year time horizon for patients with advanced NSCLC. The model consisted of 3 health states: alive with no progression, alive with progression and dead. Key clinical inputs were based on Kaplan-Meier survival curves from the interim (median follow-up 11.2 months) and updated analysis (median follow-up 25.2 months) of the KEYNOTE-024 randomized controlled trial. Local cost data were applied. Utilities were derived from published international estimates. Both one-way and multivariate probabilistic sensitivity analyses (PSA) were conducted to identify key drivers of the results.
RESULTS


Using the results from the updated analysis of KEYNOTE-024, patients treated with pembrolizumab experienced more quality adjusted life-years (QALYs), but incurred higher costs compared to chemotherapy over a 10-year time horizon (pembrolizumab: 1.9983 QALYs, SGD215,761; chemotherapy: 1.1317 QALYs, SGD70,444). The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained. One-way sensitivity analysis showed the ICER was most sensitive to the cost of pembrolizumab, followed by the time horizon. Multivariate PSA indicated that pembrolizumab had 0% probability of being cost-effective at a hypothetical willingness-to-pay threshold of SGD100,000 per QALY gained.
CONCLUSION


While pembrolizumab is superior to standard chemotherapy in improving overall survival and progression-free survival, results suggest that it is unlikely to be cost-effective at its current price in Singapore. Factors including clinical effectiveness, safety and budget impact should also be considered when making national funding decisions.",2020,"The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained.","['previously untreated advanced non-small cell lung cancer', 'advanced non-small cell lung cancer (NSCLC) in previously untreated adults who have a high programmed death ligand 1 (PD-L1) tumor proportion score of 50% or greater in Singapore', 'patients with advanced NSCLC']","['pembrolizumab monotherapy versus chemotherapy', 'pembrolizumab monotherapy', 'standard chemotherapy', 'pembrolizumab', 'platinum doublet chemotherapy']","['quality adjusted life-years (QALYs', 'clinical effectiveness, safety and budget impact', 'cost-effectiveness', 'overall survival and progression-free survival', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.169454,"The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained.","[{'ForeName': 'Mohamed Ismail Abdul', 'Initials': 'MIA', 'LastName': 'Aziz', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}, {'ForeName': 'Ling Eng', 'Initials': 'LE', 'LastName': 'Tan', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}, {'ForeName': 'Wan Hui Gloria', 'Initials': 'WHG', 'LastName': 'Tan', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}, {'ForeName': 'Chee-Keong', 'Initials': 'CK', 'LastName': 'Toh', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre, Singapore.'}, {'ForeName': 'Lydia Pui Yee', 'Initials': 'LPY', 'LastName': 'Loke', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}, {'ForeName': 'Kwong', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore.'}]",Journal of medical economics,['10.1080/13696998.2020.1775620']
2751,32462979,Early and sustained symptom improvement with umeclidinium/vilanterol  versus  monotherapy in COPD: a  post hoc  analysis of the EMAX randomised controlled trial.,"BACKGROUND


In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained.
METHODS


Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured  via  an electronic diary and analysed initially in 4-weekly periods.  Post hoc  analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1-8), and association between E-RS:COPD responder status at Weeks 1-4 and later time points.
RESULTS


In the intent-to-treat population ( n  = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60-85%) retained their Weeks 1-4 E-RS:COPD responder/non-responder status at Weeks 21-24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1-4, 70% were responders at Weeks 21-24.
CONCLUSION


Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI  versus  either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient's likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care.
CLINICAL TRIAL REGISTRATION


NCT03034915, 2016-002513-22 (EudraCT Number).  The reviews of this paper are available via the supplemental material section.",2020,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"['chronic obstructive pulmonary disease (COPD', 'COPD', '2016-002513-22 (EudraCT Number', 'patients with COPD with']","['umeclidinium/vilanterol  versus  monotherapy', 'E-RS:COPD', 'bronchodilator therapy', 'EMAX', 'umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol']","['daily E-RS:COPD score and rescue medication', 'COPD stability']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.52709,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Crisor LLC, Clinical Research Institute, 3860 Crater Lake Ave., Medford, OR 97504, USA.'}, {'ForeName': 'Isabelle H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Keeley', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926949']
2752,32465246,30 Day Survival in Heart Transplant Patients Bridged with Short Term Mechanical Circulatory Support: Are We Failing to Rescue?,"PURPOSE


UNOS heart allocation policy has changed with patients receiving temporary MCS being prioritized. Failure to rescue (FTR) describes a phenomenon where patients with in-hospital complications demonstrate increased 30 day mortality. We sought to identify 30 day mortality rates in BTT recipients supported with temporary MCS.
METHODS


International Society for Heart and Lung Transplantation (ISHLT) provided de-identified patient data. Between 2005 and 2018, 63,866 heart transplant recipients ≥18 years were identified. Of these, 658 (1.0%) were bridged with VA-ECMO, 1991 (3.1%) with IABP, 11960 (18.7%) with continuous-flow LVAD. Patients who underwent re-operative heart transplantation were excluded.
RESULTS


Patients who were pre-operatively supported with VA-ECMO were younger when compared to the IABP or LVAD group. Donors were more likely to be older, female, and with a slightly longer ischemic time when transplanted into VA-ECMO recipients compared to IABP or LVAD recipients (Table 1). Kaplan-Meier analysis demonstrated a post-transplant survival of 81% (124/658 VA-ECMO), 95% (104/1991 IABP), 95% (552/11960 LVAD), at 30 days (p < 0.001).
CONCLUSION


BTT with VA-ECMO is associated with decreased 30-day survival compared to IABP or LVADs. With the prioritization of patients transplanted from temporary MCS, multi-institutional collaborative efforts are necessary to define if FTR versus specific donor or recipient factors contribute to this survival differential.",2020,"Kaplan-Meier analysis demonstrated a post-transplant survival of 81% (124/658 VA-ECMO), 95% (104/1991 IABP), 95% (552/11960 LVAD), at 30 days (p < 0.001).
","['International Society for Heart and Lung Transplantation (ISHLT) provided de-identified patient data', 'Patients who underwent re-operative heart transplantation were excluded', 'Between 2005 and 2018, 63,866 heart transplant recipients ≥18 years were identified', 'Heart Transplant Patients', 'BTT recipients supported with temporary MCS', 'patients receiving temporary MCS being prioritized']",['Bridged with Short Term Mechanical Circulatory Support'],"['mortality rates', '30-day survival', 'transplant survival', 'ischemic time']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0018833', 'cui_str': 'Heart and lung transplant'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}]","[{'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",63866.0,0.0694682,"Kaplan-Meier analysis demonstrated a post-transplant survival of 81% (124/658 VA-ECMO), 95% (104/1991 IABP), 95% (552/11960 LVAD), at 30 days (p < 0.001).
","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Fiedler', 'Affiliation': 'Cardiothoracic Surgery, University of Wisconsin, Madison, WI.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Lushaj', 'Affiliation': 'Cardiothoracic Surgery, University of Wisconsin, Madison, WI.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Cardiology, University of Wisconsin, Madison, WI.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hermsen', 'Affiliation': 'Cardiothoracic Surgery, University of Wisconsin, Madison, WI.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': 'Cardiothoracic Surgery, University of Wisconsin, Madison, WI.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.585']
2753,32465256,Comparison of Six-Month Outcomes in Patients with Cardiac Amyloidosis before and after the UNOS Allocation System Change.,"PURPOSE


Advanced amyloid cardiomyopathy (ACM) patients have high waitlist (WL) mortality. Given the greater emphasis and clarity for status exceptions for ACM patients in the new allocation system, we sought to assess whether this change in the allocation policy would affect the WL and post-transplant outcomes in ACM pts.
METHODS


Thirty-five patients were identified in the UNOS database that underwent heart transplant (HT) with a prior diagnosis of ACM during a 6-month period immediately before and after the policy change. Comparisons between patient characteristics in the pre (n=24) and post (n=11) policy-change cohorts are reported using standard statistical methods; survival analysis was performed using Cox proportional hazards modeling.
RESULTS


The WL statuses of the pre patients were 1A (n=15), 1B (n=5), 2 (n=4) while the WL statuses of the post patients were 2 (n=7), 3 (n=2), 4 (n=2). The recipient age, donor age, gender, ethnicity, diabetes status, and ischemic time were similar for both groups. Total days on WL for pre and post were similar (26.0 days vs 29.0 days, p=0.82). The use of IABP was greater following the policy change (55% post vs 4% pre, p<0.001). Pre-transplant hemodynamic parameters and serum creatinine were similar before and after the policy change. Additionally, there was no difference in 6-month survival between the groups (p=0.58).
CONCLUSION


The heart allocation policy change did not significantly decrease wait list times in ACM patients awaiting heart transplant, however there was significant greater utilization of pre-transplant IABP use. There were overall fewer patients that underwent HT in the 6 months following implementation of the new system, and there was no observed difference in 6-month post-HT survival for patients with ACM in the new allocation system.",2020,"The use of IABP was greater following the policy change (55% post vs 4% pre, p<0.001).","['pre patients were 1A (n=15), 1B (n=5), 2 (n=4) while the WL statuses of the post patients were 2 (n=7), 3 (n=2), 4 (n=2', 'ACM patients awaiting heart transplant', 'Patients with Cardiac Amyloidosis before and after the UNOS Allocation System Change', 'Thirty-five patients were identified in the UNOS database that underwent heart transplant (HT) with a prior diagnosis of ACM during a 6-month period immediately before and after the policy change']",[],"['wait list times', '6-month survival', '6-month post-HT survival', 'Pre-transplant hemodynamic parameters and serum creatinine', 'IABP']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]",[],"[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump'}]",35.0,0.0658537,"The use of IABP was greater following the policy change (55% post vs 4% pre, p<0.001).","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Li', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Kingsford', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Liu', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nattiv', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Genyk', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wolfson', 'Affiliation': 'Internal Medicine, University of Arizona Sarver Heart Center, Tuscon, AZ.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vucicevic', 'Affiliation': 'Internal Medicine, Newark Beth-Israel, Newark, NJ.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Banankhah', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salimbangon', 'Affiliation': 'Internal Medicine, UCLA Medical Center, Los Angeles, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fong', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pandya', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Grazette', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'DePasquale', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Vaidya', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.592']
2754,32465270,Does the Dose of Mycophenolate Mofetil Impact Outcome after Heart Transplantation?,"PURPOSE


Mycophenolate mofetil (MMF) is an anti-proliferative agent that is used in heart transplantation (HTx). The multicenter randomized trial of mycophenolate published in Transplantation in 1998 demonstrated that MMF had a survival benefit. The average dose of MMF was 2.8 g/day. It is not clear whether lower doses of MMF also have benefit in terms of control of rejection as well as other outcomes.
METHODS


Between 2010 and 2018, we assessed 240 HTx patients and divided them into categories of MMF dosing in the first year after HTx. The average daily dose of MMF was obtained for all patients in the first year, with an average of 10 MMF dose levels obtained over the first year. Patients were divided into groups based on receiving an average daily dose of <500 mg MMF/day, 500-1000 mg/day, 1001-1500 mg/day, 1501-2000 mg/day, and >2000 mg/day. Endpoints included 1-year survival, 1-year freedom from cardiac allograft vasculopathy (CAV), 1-year freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, percutaneous coronary intervention/angioplasty, new congestive heart failure, pacemaker/implantable cardioverter-defibrillator placement, and stroke), and 1-year freedom from rejection (any treated rejection (ATR), acute cellular rejection (ACR), antibody mediated rejection (AMR)).
RESULTS


Patients treated with <500 mg MMF/day and >2000 mg MMF/day had a trend toward decreased freedom from ATR. There was no difference in outcome between all groups in terms of 1-year survival, freedom from CAV, freedom from NF-MACE, and freedom from ACR and AMR.
CONCLUSION


The average daily dose of MMF in the first year after HTx does not appear to have an impact on outcome. Longer follow-up will be necessary to assess whether MMF dosing correlates to long-term complications such as CAV. Larger number of patients will be needed to confirm these findings.",2020,"There was no difference in outcome between all groups in terms of 1-year survival, freedom from CAV, freedom from NF-MACE, and freedom from ACR and AMR.
","['Between 2010 and 2018', '240 HTx patients and divided them into categories of MMF dosing in the first year after HTx']","['MMF', 'Mycophenolate mofetil (MMF', 'mycophenolate', 'Mycophenolate Mofetil']","['1-year survival, freedom from CAV, freedom from NF-MACE, and freedom from ACR and AMR', 'survival benefit', 'average daily dose of MMF', 'freedom from ATR', '1-year survival, 1-year freedom from cardiac allograft vasculopathy (CAV), 1-year freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, percutaneous coronary intervention/angioplasty, new congestive heart failure, pacemaker/implantable cardioverter-defibrillator placement, and stroke), and 1-year freedom from rejection (any treated rejection (ATR), acute cellular rejection (ACR), antibody mediated rejection (AMR']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0564471', 'cui_str': 'Allograft heart'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1706799', 'cui_str': 'amrubicin hydrochloride'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]",240.0,0.0376386,"There was no difference in outcome between all groups in terms of 1-year survival, freedom from CAV, freedom from NF-MACE, and freedom from ACR and AMR.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kittleson', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Chang', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nishihara', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shen', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mersola', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Velleca', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hage', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Czer', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Emerson', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kobashigawa', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.607']
2755,32465280,A Novel Immunosuppressive Regiment for Cardiac Transplant Patients.,"PURPOSE


Heart transplantation remains curative for end-stage heart failure. The choice between immunosuppressive regimens is guided by several principles: mitigating the risk of rejection early after transplantation, limiting drug toxicity of immunosuppressants, and minimizing over-suppression. We sought to investigate the efficacy of a novel immunosuppressive regimen targeting a lower therapeutic range (LTR) for Tacrolimus without antecedent induction therapy compared with a standard therapeutic range (STR). The protocol was implemented after 2016 and included the administration of Tacrolimus to a goal trough of 6-8 ng/mL immediately post transplant, Mycophenolate mofetil 1000-15000 mg BID, and Prednisone 1 mg/kg/day post-op divided into two doses and tapered by 5 mg Daily.
METHODS


A retrospective chart review was performed comparing transplant outcomes utilizing the novel LTR immunosuppression regimen compared to STR from 2008-2019. Primary outcomes included infection, bone marrow suppression and rejection within the first 3 years of transplantation.
RESULTS


Of the 83 patients analyzed, 25 (30%) received the lower Tacrolimus dosing regimen (LDR), and 58 received the standard dosing regimen (SDR). Patients in the LDR group were younger (56.2 +/- 12.2 years vs 61.8 +/- 10.4 years) and less likely to be male (68% vs 87.9%). Rates of high risk CMV donor/recipient status was similar between the two groups. There was no statistically significant difference between the LDR group and SDR group with respect to rates of infection (44% vs 34.5%, p=0.41), bone marrow suppression (20% vs 13.8%, p=0.47), or > 2R CMR (24% vs 32.8%, p=0.42).
CONCLUSION


In this single-center study we compared a conventional post-transplant immunosuppression regimen with one that utilized a lower Tacrolimus trough goal (6-8ng/mL). There was no statistical difference between the two groups in rates of rejection, bone marrow suppression, or infectious complications. We present a successful novel immunosuppression regiment that could serve to benefit patients with intolerance to higher doses of calcineurin inhibitors with no adverse outcomes. Future studies are needed to determine the impact of LTR on renal function.",2020,"There was no statistically significant difference between the LDR group and SDR group with respect to rates of infection (44% vs 34.5%, p=0.41), bone marrow suppression (20% vs 13.8%, p=0.47), or > 2R CMR (24% vs 32.8%, p=0.42).
","['83 patients analyzed, 25 (30%) received the lower Tacrolimus dosing regimen (LDR), and 58 received the standard dosing regimen (SDR', 'Patients in the LDR group were younger (56.2 ', 'Cardiac Transplant Patients']","['Tacrolimus without antecedent induction therapy', 'Mycophenolate mofetil 1000-15000 mg BID, and Prednisone', 'Tacrolimus', 'calcineurin inhibitors', 'LDR', 'standard therapeutic range (STR', 'novel LTR immunosuppression regimen']","['bone marrow suppression', 'infection, bone marrow suppression and rejection within the first 3 years of transplantation', 'rates of infection', 'Rates of high risk CMV donor/recipient status', 'rates of rejection, bone marrow suppression, or infectious complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4517583', 'cui_str': '15000'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0433185,"There was no statistically significant difference between the LDR group and SDR group with respect to rates of infection (44% vs 34.5%, p=0.41), bone marrow suppression (20% vs 13.8%, p=0.47), or > 2R CMR (24% vs 32.8%, p=0.42).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vojnika', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vishnevsky', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Farzad', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zimmerman', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ryan', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Demastus', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boyle', 'Affiliation': 'Cardiology, Largo Medical Center, Tampa Bay, FL.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Danelich', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pirlamarla', 'Affiliation': 'Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.614']
2756,32465391,Wait or No Wait for Reducing Body Weight before Lung Transplant.,"PURPOSE


Lung transplant (LTx) candidates may have both high and low body-mass index (BMI). We investigated the effects of BMI in lung transplantation outcome and survival.
METHODS


Patients from our center (Feb-2012 to Jul-2019) were divided into 5 BMI groups: <18.5, <25, <30, <35, ≥35 kg/m 2  using WHO's nutritional standards. Using Cox proportional hazard regression, we examined any differences between these groups in age, gender, race, length of stay (LOS), lung allocation score (LAS), single, and double LTx type. Kaplan-Meier curve showed survival outcomes between the groups compared by Log-rank test. Data were presented as Mean ± Standard deviation and p<0.05 was considered significant.
RESULTS


Out of 609 LTx recipients, etiology was 63.1% IPF, 24.3% COPD, and 12.6% others. Furthermore, 28.2% of patients were either underweight or normal weight, 36.9% were overweight, and 34.7% were obese as measured by BMI. Demographically, the patient population was 66% male, mean age 64±9, race 78% white 15% black, and 7% others, median LOS (17 days) and mean LAS 49±19. Kaplan-Meier graph (figure 1) showed no significant differences in 1,3,5 year survival among all the BMI groups (p=0.57). There were also no significant differences among all the groups with regard to LOS (p=0.91) and LAS (p=0.42).
CONCLUSION


Despite larger numbers of overweight patients, there was no evidence of negative effect in survival outcome after LTx. Additionally, LOS and LAS did not have any effect in survival among five groups of BMI. This outcome suggests lung transplantation could be expanded to a wider variety of BMI patients.",2020,"There were also no significant differences among all the groups with regard to LOS (p=0.91) and LAS (p=0.42).
","['Patients from our center (Feb-2012 to Jul-2019', 'Demographically, the patient population was 66% male, mean age 64±9, race 78% white 15% black, and 7% others, median LOS (17 days) and mean LAS 49±19', '609 LTx recipients', 'overweight patients']","['LOS and LAS', 'BMI']","['survival outcome', 'underweight or normal weight', 'survival', '1,3,5 year survival', 'Body Weight', 'length of stay (LOS), lung allocation score (LAS), single, and double LTx type', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C4720844', 'cui_str': 'Lung allocation score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",609.0,0.0265319,"There were also no significant differences among all the groups with regard to LOS (p=0.91) and LAS (p=0.42).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Guynn', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kashem', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Brann', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Minakata', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Gengo', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Leotta', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Shigemura', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Toyoda', 'Affiliation': 'Cardiothoracic Surgery, Temple University Hospital, Philadelphia, PA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.716']
2757,32465397,Validation of REVEAL Risk Score Calculator 2.0 in Patients with CTEPH in the Phase III CHEST Study.,"PURPOSE


The REVEAL risk score (RRS) predicts 1-year survival in patients with pulmonary arterial hypertension; it also improved with riociguat in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) in the Phase III CHEST-1 study, and predicted survival and clinical worsening-free survival (CWFS) in the long-term extension CHEST-2. RRS 2.0, an updated RRS, was developed based on modified point values, cut-offs, and variables. This post hoc analysis aimed to validate RRS 2.0 in the CHEST database (a population not derived from REVEAL), as done previously, and assess if the tool discriminates outcomes in a carefully selected and followed patient population.
METHODS


RRS 2.0 was calculated for patients receiving riociguat up to 2.5 mg tid or placebo (pbo) at CHEST-1 baseline (BL) and Week 16, and CHEST-2 Week 12. Only patients enrolled in CHEST-2 were included. Patients were stratified by RRS 2.0 into low (≤7), average/moderately high (8-9), and high/very high (≥10) risk strata at BL and Week 16. Relationship between RRS 2.0 and survival and CWFS in CHEST-2 was examined by Kaplan-Meier and Cox proportional hazards analyses.
RESULTS


At baseline, mean±SD RRS 2.0 was 7.1±2.7 in riociguat patients (n=155) and 6.9±2.6 in pbo patients (n=82). Risk status at BL was low in 131 patients (55%), average/moderately high in 59 (25%), and high/very high in 47 (20%). At CHEST-1 Week 16, riociguat improved RRS 2.0 by a least squares mean difference of -1.48 vs. pbo (95% CI -1.97 to -0.99; p<0.0001); risk status improved in 70% with riociguat and 39% with pbo patients (p<0.0001). At CHEST-2 Week 12, RRS 2.0 improved to 5.5±3.1 (n=152) and 6.1±3.1 (n=79) in riociguat and former pbo patients, respectively. In CHEST-2 (median [range] treatment duration 116 [2-232] weeks), Cox proportional hazards analyses showed RRS 2.0 at CHEST-1 BL and Week 16 was significantly associated with survival and CWFS (p<0.0001). Kaplan-Meier analyses showed significant differences in survival and CWFS between patients in the three risk strata at CHEST-1 BL and Week 16 (p<0.0001).
CONCLUSION


Riociguat improved RRS 2.0 and risk strata in CHEST-1. RRS 2.0 predicted survival and CWFS over two years in CHEST-2. Thus, RRS 2.0 may be a useful tool to predict outcomes in patients with CTEPH. Further assessment of the discriminatory power of RRS 2.0 vs. the original RRS will be done.",2020,p<0.0001); risk status improved in 70% with riociguat and 39% with pbo patients (p<0.0001).,"['patients with pulmonary arterial hypertension', 'patients with CTEPH', 'patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH', 'Only patients enrolled in CHEST-2 were included', 'Patients were stratified by RRS 2.0 into low (≤7), average/moderately high (8-9), and high/very high (≥10) risk strata at BL and Week 16']","['CHEST-1', 'riociguat up to 2.5 mg tid or placebo']","['Risk status at BL', 'survival and CWFS', 'RRS 2.0 predicted survival and CWFS', 'risk status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.050058,p<0.0001); risk status improved in 70% with riociguat and 39% with pbo patients (p<0.0001).,"[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Benza', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Farber', 'Affiliation': 'Pulmonary Hypertension Center, Boston University/Boston Medical Center, Boston, MA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Frost', 'Affiliation': 'Department of Medicine, Houston Methodist, Houston, TX.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Member of the German Center for Lung Research (DZL), University of Giessen and Marburg Lung Center (UGMLC), Glessen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Corris', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brockmann', 'Affiliation': 'CHRESTOS Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nikkho', 'Affiliation': 'Global Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meier', 'Affiliation': 'Global Medical Affairs, Bayer AG, Berlin, Germany.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Clinic for Respiratory Medicine, Hannover Medical School, Member of the German Center for Lung Research (DZL), Hannover, Gibraltar.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1182']
2758,32465406,Comprehensive Immunophenotypic Monitoring in a Prospective Randomized Controlled Trial of Prophylactic Use of Extracorporeal Photopheresis (ECP) in Lung Transplantation.,"PURPOSE


Extracorporeal photopheresis (ECP) is an accepted treatment option for acute and chronic rejection after solid organ transplantation but the mode of action is not fully elucidated. In a randomized controlled trial that investigates the addition of prophylactic use of ECP to a tacrolimus-based immunosuppressive regimen after lung transplantation, a comprehensive phenotypic immune monitoring is performed to assess the immunomodulatory effects of ECP.
METHODS


To date, 40 (from a calculated sample size of 62) end-stage chronic obstructive pulmonary disease (COPD) patients underwent bilateral lung transplantation and were randomized into 2 treatment arms - the control group received standard triple immunosuppression consisting of tacrolimus, mycophenolate mofetil and steroids while the second group additionally received 16 ECP treatments in the first three months after surgery. For monitoring a comprehensive set of leukocyte subsets such as regulatory T cells (CD4+CD25+FoxP3+ Tregs) polychromatic flow cytometry analysis was performed on fresh whole blood samples using validated, standardized, lyophilized monoclonal antibody panels (DuraClone). Samples were acquired before and 3 months after transplantation, when the last ECP treatment was performed, as well as 6 months after transplantation. Statistical analysis was conducted by using a two-tailed paired and unpaired t-test.
RESULTS


From 40 double lung transplanted patients, 32 patients have reached their three-month-visit and 28 patients their 6-months-visit. No significant difference in the frequency of Tregs was found between both groups at baseline (p=0.425). At 3 months, Tregs have significantly decreased in the control group (p=0.009) while in the ECP-treated group no significant decline was seen (p=0.141). Six months after transplantation the frequency of Tregs was significantly decreased in both groups when compared to baseline (p=0.043 in control; p=0.030 in ECP-treated).
CONCLUSION


Preliminary data from this interim analysis of double lung transplanted patients receiving ECP as prophylactic treatment provide evidence that during ECP treatments the post-transplant decline in Treg frequency seen with standard immunosuppression is prevented.",2020,"At 3 months, Tregs have significantly decreased in the control group (p=0.009) while in the ECP-treated group no significant decline was seen (p=0.141).","['Lung Transplantation', 'To date, 40 (from a calculated sample size of 62', 'end-stage chronic obstructive pulmonary disease (COPD) patients underwent bilateral lung transplantation']","['Extracorporeal Photopheresis (ECP', 'standard triple immunosuppression consisting of tacrolimus, mycophenolate mofetil and steroids while the second group additionally received 16 ECP treatments', 'tacrolimus-based immunosuppressive regimen', 'ECP', 'Extracorporeal photopheresis (ECP']",['frequency of Tregs'],"[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1277261', 'cui_str': 'End stage chronic obstructive airways disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396599', 'cui_str': 'Double lung transplant'}]","[{'cui': 'C0206373', 'cui_str': 'Extracorporeal photopheresis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",62.0,0.0643227,"At 3 months, Tregs have significantly decreased in the control group (p=0.009) while in the ECP-treated group no significant decline was seen (p=0.141).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mraz', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weijler', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guth', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Muraközy', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Just', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Knobler', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spittler', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoetzenecker', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jaksch', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wekerle', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.730']
2759,32465436,Reverse Myocardial Remodeling with Centrifugal versus Axial-Flow Left Ventricular Assist Device in Chronic Heart Failure Patients.,"PURPOSE


Recent studies have shown enhanced survival and reduced morbidity with centrifugal (HeartMate 3-HM3) left ventricular assist device (LVAD) compared with axial-flow (HeartMate II-HMII) LVAD. However, differences in LVAD-induced left ventricular (LV) reverse remodeling between the two devices remain uninvestigated. The aim of our study was to compare the LV structural and functional changes between these two types of mechanical unloading.
METHODS


Echocardiographic parameters of LV structure and function were obtained pre-implant and at 1, 3, 6, and 12 month of LVAD support. Statistical comparison of quantitative data was performed using 2-tailed Wilcoxon signed-rank test for paired samples and categorical data were compared using Fisher's exact test.
RESULTS


A total of 32 consecutive patients (median age 62.5 [IQR 52-68] years, 15.6% female) received axial-flow LVAD (HMII) and 31 consecutive patients (median age 58 [IQR 47-71] years, 16.1% female) received centrifugal LVADs (HM3). There were no significant differences in the baseline characteristics between the study groups. Following LVAD support there were no differences in the LV ejection fraction or LV mass index between the two types of mechanical unloading across all time points (figure 1A and 1B). In centrifugal LVAD patients, LV end diastolic volume index was lower at 1 and 3 months and LV end systolic volume index was lower at 1 month. No differences were identified after 3 months of mechanical unloading (figure 1C and 1D).
CONCLUSION


Both centrifugal and axial-flow LVADs resulted in improved LV function and structure. Although LV volumes were found to be lower at 1 and 3 months in centrifugal pump patients, long-term (> 3month) mechanical unloading seem to exert similar effects on LV structural and functional parameters.",2020,Following LVAD support there were no differences in the LV ejection fraction or LV mass index between the two types of mechanical unloading across all time points (figure 1A and 1B).,"['and 31 consecutive patients (median age 58 [IQR 47-71] years, 16.1% female) received', '32 consecutive patients (median age 62.5 [IQR 52-68] years, 15.6% female) received', 'Chronic Heart Failure Patients']","['axial-flow LVAD (HMII', 'centrifugal (HeartMate 3-HM3) left ventricular assist device (LVAD', 'axial-flow (HeartMate II-HMII) LVAD', 'Centrifugal versus Axial-Flow Left Ventricular Assist Device', 'centrifugal LVADs (HM3']","['LV structural and functional changes', 'LV end systolic volume index', 'LV end diastolic volume index', 'mechanical unloading (figure 1C and 1D', 'LV ejection fraction or LV mass index', 'LV function and structure', 'LVAD-induced left ventricular (LV) reverse remodeling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C1301962', 'cui_str': 'Centrifugal'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",32.0,0.0277719,Following LVAD support there were no differences in the LV ejection fraction or LV mass index between the two types of mechanical unloading across all time points (figure 1A and 1B).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Wever-Pinzon', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Taleb', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Alharethi', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, Intermountain Heart Intesitute, Salt Lake City, UT.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dranow', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kfoury', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, Intermountain Heart Intesitute, Salt Lake City, UT.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Reid', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, Intermountain Heart Intesitute, Salt Lake City, UT.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McKellar', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koliopoulou', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nativi-Nicolau', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kemeyou', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Selzman', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Drakos', 'Affiliation': 'U.T.A.H. Cardiac Transplant Program, University of Utah School of Medicine, Salt Lake City, UT.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.357']
2760,32465438,Gender Differences in Clinical Outcomes after Left Ventricular Assist Device (LVAD) Implantation - Does Device Strategy Matter?,"PURPOSE


Findings regarding outcomes after LVAD implantation in women and men are inconsistent, which may be due to combining data from patients differing in device strategy. The present analyses explored gender differences at baseline in medical and psychosocial patient characteristics and multiple clinical outcomes, stratified for patients bridged to transplantation (BTT) and those intended for destination therapy (DT).
METHODS


8,461 patients in DT (20% women), and 11,189 patients in BTT (22% women), who received a primary continuous-flow LVAD between 6/2006 and 12/2017 and were registered with INTERMACS, were analyzed by device strategy and gender. Outcomes included death, transplant, device explant due to recovery, and device replacement due to complications. Associations of gender with time until each competing outcome were evaluated using cumulative incidence function and cause-specific Cox proportional hazard models, controlling for age, disease severity, hematological parameters, and psychosocial factors (e.g., marital status, social support, depression, history of alcohol abuse, and smoking).
RESULTS


In both BTT and DT, women were younger, reported less substance abuse, were less likely to be white, married and working for an income, but more likely to be depressed than men. In BTT, men were more likely to be currently smoking, whereas in DT, women were more likely to be smoking. In DT, women were also more likely to be overweight. Regarding outcomes, during a mean follow up of 19 months, women had an increased rate of death compared to men in BTT [HR 1.11, 95% CI (1.00-1.23), p < .05], but not in DT [HR 1.01, 95% CI (0.91-1.12)]; women's rate of device replacement, however was increased only in DT [HR 1.19, 95% CI (1.03-1.39), p < .05]. Only in BTT had women a lower rate to be transplanted than men [HR 0.83, 95% CI (0.76-0.90), p < .001]. In both BTT and DT, women had higher rates for explant due to heart function recovery than men, even after controlling for medical and psychosocial covariates [DT: HR 1.79, 95% CI (1.27-2.56), p < .01; BTT: HR 1.33 95% CI (1.00-1.79), p < .05].
CONCLUSION


The results indicate that women and men differ in outcomes depending on intended device strategy. Thus, distinguishing between device strategies may help to understand gender differences in clinical outcomes after LVAD implantation.",2020,"In both BTT and DT, women had higher rates for explant due to heart function recovery than men, even after controlling for medical and psychosocial covariates [DT: HR 1.79, 95% CI (1.27-2.56), p < .01; BTT: HR 1.33 95% CI (1.00-1.79), p < .05].
","['women and men', 'patients bridged to transplantation (BTT) and those intended for destination therapy (DT).\nMETHODS\n\n\n8,461 patients in DT (20% women), and 11,189 patients in BTT (22% women), who received a primary continuous-flow LVAD between 6/2006 and 12/2017 and were registered with INTERMACS, were analyzed by device strategy and gender']","['LVAD implantation', 'Left Ventricular Assist Device (LVAD) Implantation ']","['heart function recovery', 'rate of death', 'cumulative incidence function and cause-specific Cox proportional hazard models, controlling for age, disease severity, hematological parameters, and psychosocial factors (e.g., marital status, social support, depression, history of alcohol abuse, and smoking', 'death, transplant, device explant due to recovery, and device replacement due to complications']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221628', 'cui_str': 'History of alcohol abuse'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.145933,"In both BTT and DT, women had higher rates for explant due to heart function recovery than men, even after controlling for medical and psychosocial covariates [DT: HR 1.79, 95% CI (1.27-2.56), p < .01; BTT: HR 1.33 95% CI (1.00-1.79), p < .05].
","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Maukel', 'Affiliation': 'Health Psychology, Trier University, Trier, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Weidner', 'Affiliation': 'Biology, San Francisco State University, San Francisco, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beyersmann', 'Affiliation': 'Institute of Statistics, Ulm University, Ulm, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Spaderna', 'Affiliation': 'Health Psychology, Trier University, Trier, Germany.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.361']
2761,32465450,Real World Experience with the HeartMate 3 (HM3) Left Ventricular Assist Device (LVAD): Analysis of the First 125 Consecutive Patients at a Single Institution.,"PURPOSE


Excellent outcomes following HM3 LVAD implantation have been reported in the setting of a large multicenter randomized controlled trial. Real world experience reports with this device are still limited. We sought to review our experience with this fully magnetically levitated LVAD.
METHODS


The first 125 consecutive patients who received a HM3 LVAD at our institution from October 1, 2015 to August 30, 2019 were analyzed. Pump exchange procedures were excluded. We investigated clinical outcomes including survival and the development of postoperative complications.
RESULTS


All devices were implanted via median sternotomy. Mean patient age was 57.5 ± 11 years, 72 % were males and 74% African-Americans. Idiopathic dilated cardiomyopathy was the most common diagnosis (73%). 67 % of the patients were INTERMACS profiles 1 or 2. 19 % of devices were implanted as bridge to transplant and 59% as destination therapy. Mean body-mass index at the time of implant was 30.5 ± 8 Kg/m 2 . Mean creatinine level was 1.29 ± 0.4 mg/dl and mean bilirubin was 1.45 ± 1.6 mg/dl. The mean length of stay during index admission for LVAD was 30 ± 17 days and the mean follow-up time was 411 ± 34 days. The rate of complications measured as EPPY was 0.42 for GI bleeding, 0.03 for ischemic stroke, 0.01 for hemorrhagic stroke, 0 for clinically suspected pump thrombosis or confirmed pump thrombosis, 0.22 for LVAD related infection, 0.16 for other systemic infection and 0.59 for acute heart failure. Survival was estimated at 96%, 91%, 88%, 81% and 74% at 30-day, 90-day, 1-year, 2-year, and overall 3-year follow-up, respectively (Figure).
CONCLUSION


In this single center, real world experience, HeartMate 3 implantation was associated with excellent survival comparable to those demonstrated in a recent clinical trial. The incidence of complications was also low, including no episodes of suspected or confirmed pump thrombosis.",2020,"The rate of complications measured as EPPY was 0.42 for GI bleeding, 0.03 for ischemic stroke, 0.01 for hemorrhagic stroke, 0 for clinically suspected pump thrombosis or confirmed pump thrombosis, 0.22 for LVAD related infection, 0.16 for other systemic infection and 0.59 for acute heart failure.","['125 consecutive patients who received a HM3 LVAD at our institution from October 1, 2015 to August 30, 2019 were analyzed', 'Mean patient age was 57.5 ± 11 years, 72 % were males and 74% African-Americans', '125 Consecutive Patients at a Single Institution']","['HM3 LVAD implantation', 'Left Ventricular Assist Device (LVAD', 'HeartMate 3 (HM3']","['Idiopathic dilated cardiomyopathy', 'Mean body-mass index', 'Mean creatinine level', 'Survival', 'excellent survival', 'mean length of stay during index admission', 'rate of complications', 'incidence of complications']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C1449563', 'cui_str': 'Primary idiopathic dilated cardiomyopathy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",125.0,0.178553,"The rate of complications measured as EPPY was 0.42 for GI bleeding, 0.03 for ischemic stroke, 0.01 for hemorrhagic stroke, 0 for clinically suspected pump thrombosis or confirmed pump thrombosis, 0.22 for LVAD related infection, 0.16 for other systemic infection and 0.59 for acute heart failure.","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Molina', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Rodrigo', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hofmeyer', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kadakkal', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kitahara', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Sheikh', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.373']
2762,32465457,"Weight and LVAD Outcomes; Not Just a ""Bridge to the Fridge?""","PURPOSE


Obesity in LVAD recipients has been well documented. There is a lack of data on the predictive effect of baseline weight and weight gain after LVAD implantation on morbidity and mortality. The aim of our study was to evaluate if weight at LVAD implant and the change in weight during LVAD support could predict morbidity and/or mortality.
METHODS


We reviewed the impact of baseline weight and weight gain on post-LVAD survival in patients who received a durable LVAD at our institution from January 1, 2014 until December 31, 2017. Patients who were supported for more than 12 months were divided into two groups: patients with baseline BMI < 30 (NW) and BMI > 30 (OW) and were evaluated for association of weight change with overall survival and freedom from LVAD related complications.
RESULTS


Baseline characteristics of 189 patients are summarized in Table 1. One year survival was 74 ± 5% in patients with baseline BMI <30, and 77 ± 5% in patients with BMI >30. Baseline BMI was not associated with survival in multivariate Cox proportional hazard analysis (P = 0.91). Out of 89 patients who were still being supported 12 months after the LVAD implantation, 51 (57%) had BMI >30. Median weight gain in NW group at 12 months was 12(6,18)kg compared to 7(3,12)kg in OW group (P=0.02). There was no association of BMI at 12 months or weight change with overall post-LVAD survival, freedom from infection, pump malfunction, and neurological dysfunction. Freedom from right heart dysfunction at 12 months was 84 ± 5% in patients with BMI>30 compared to 97±3% in patients with BMI<30. For patients who crossed over from a baseline BMI<30 to BMI>30 at 12 months, weight gain emerged as a significant predictor of right heart failure (HR: 16.133 [95% CI; 1.806-145.026] p=0.013) CONCLUSION: Baseline, as well as 12 months post implantation BMI, had no impact on overall post-LVAD survival. Patients with NW at implant who crossed over to OW had no effect on survival, infection, pump complication or neurological dysfunction. However, this population had significantly less freedom from right heart failure.",2020,"Patients with NW at implant who crossed over to OW had no effect on survival, infection, pump complication or neurological dysfunction.","['89 patients who were still being supported 12 months after the LVAD implantation, 51 (57%) had BMI >30', '189 patients are summarized in Table 1', 'Patients who were supported for more than 12 months', 'patients who received a durable LVAD at our institution from January 1, 2014 until December 31, 2017', 'LVAD recipients']",['LVAD implantation'],"['Median weight gain', 'overall post-LVAD survival', 'weight change with overall post-LVAD survival, freedom from infection, pump malfunction, and neurological dysfunction', 'weight change with overall survival and freedom from LVAD related complications', 'BMI', 'survival, infection, pump complication or neurological dysfunction', 'Baseline BMI', 'right heart failure', 'morbidity and mortality', 'Weight and LVAD Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1720302', 'cui_str': 'Until'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",89.0,0.180343,"Patients with NW at implant who crossed over to OW had no effect on survival, infection, pump complication or neurological dysfunction.","[{'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Ryan', 'Affiliation': 'Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Clark', 'Affiliation': 'Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Lehn', 'Affiliation': 'Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Lyden', 'Affiliation': 'Biostatistics - College of Public Health, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Urban', 'Affiliation': 'Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, NE.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.381']
2763,32465458,Right Ventricular Function Does Not Significantly Influence 6-Minute Walk Distance in Patients with LVAD.,"PURPOSE


6-minute walk distance (6MWD) is a predictor of outcome in patients with left ventricular assist device (LVAD). The aim of this study was to evaluate the exercise capacity and LVAD-flow parameters in relation to right ventricular function.
METHODS


All patients that presented at our center 6 months after LVAD-Implantation underwent clinical assessment, 6 minutes-walk test (6MWT) and echocardiography (6mEcho). Patients were divided into two groups regarding 6MWD. Patients with a 6MWD <300 m were considered to have impaired exercise tolerance (i6MWD).
RESULTS


121 adult patients underwent LVAD-Implantation between 3/2018 and 2/2019. 31 patients died and 4 were lost to follow up. Patients with congenital heart disease (n=2) and patients who did not perform 6MWT or were limited in mobility by non cardiac problems (n=13) were excluded. 71 patients presented after a median of 6.25 months (IQR: [5.88, 702]) and were included. All received optimal medical heart failure therapy (23 ACE-Inhibitor or angiotensin II receptor blocker, 46 sacubitril/valsartan, 61 aldosterone antagonist, 59 beta blocker). 16 patients had i6MWD (223±66,8 m) while 55 patients showed good exercise tolerance (g6MWD) (6MWD 441±85m). There was no difference between groups regarding age (56.75 ± 11.14 vs. 55.42±11.13; p= 0.675), cause of heart failure, atrial fibrillation (31.2 vs. 39.6%; p= 0.756) or INTERMACS level. There was no significant difference in 6mEcho regarding right ventricular function (diameter of the right ventricular outflow tract (34.5±6.2 vs. 34.4±6.2 mm; p=0.969), right ventricular ejection fraction (47.5, IQR 40 to 55 vs. 45.0, IQR 45 to 55 %; p= 0.46), TAPSE (15.2±3.6 vs. 14.9±3.6 mm; p=0.314), grade of tricuspid regurgitation) between patients with i6MWD and g6MWD. It is notable that in patients with a HeartWare HVAD (n=59) LVAD-Flow increased from 4.8±0,6 to 5.6±0.75 l/min (p<0.001) and delta-pulsatility from 4.3±1.5 to 5.0±1.5 l/min (p<0.001). In patients with HeartMate 3 (n=12) LVAD-Flow increased from 4.8±0.5 to 5.0±0,5 l/min (p=0.006). Pulsatility Index (PI) of HeartMate 3 did not change significantly (from 3.8±1.4 to 3.9±1.2 (p=0.612)).
CONCLUSION


LVAD-flow increases slightly under exercise. Echocardiographic measures of RV-Function did not correlate with 6MWD and are therefore no predictor for exercise capacity.",2020,"Pulsatility Index (PI) of HeartMate 3 did not change significantly (from 3.8±1.4 to 3.9±1.2 (p=0.612)).
","['31 patients died and 4 were lost to follow up', 'patients with a HeartWare HVAD ', 'Patients with a 6MWD', 'patients with left ventricular assist device (LVAD', '16 patients had i6MWD (223±66,8 m) while 55 patients showed', 'Patients with LVAD', '121 adult patients underwent LVAD-Implantation between 3/2018 and 2/2019', 'Patients with congenital heart disease (n=2) and patients who did not perform 6MWT or were limited in mobility by non cardiac problems (n=13) were excluded', '71 patients presented after a median of 6.25 months (IQR: [5.88, 702]) and were included']","['optimal medical heart failure therapy (23 ACE-Inhibitor or angiotensin II receptor blocker, 46 sacubitril/valsartan, 61 aldosterone antagonist, 59 beta blocker']","['TAPSE', 'delta-pulsatility', '6mEcho regarding right ventricular function (diameter of the right ventricular outflow tract', 'Echocardiographic measures of RV-Function', 'good exercise tolerance (g6MWD) (6MWD 441±85m', 'exercise tolerance (i6MWD', '6-Minute Walk Distance', 'n=59) LVAD-Flow', 'Right Ventricular Function', 'right ventricular ejection fraction', 'LVAD-Flow', 'cause of heart failure, atrial fibrillation', 'LVAD-flow increases slightly under exercise', 'Pulsatility Index (PI) of HeartMate 3', 'grade of tricuspid regurgitation']","[{'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C3888927', 'cui_str': 'TAPSE'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0225892', 'cui_str': 'Structure of outflow tract of right ventricle'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0428781', 'cui_str': 'Right ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}]",121.0,0.0311883,"Pulsatility Index (PI) of HeartMate 3 did not change significantly (from 3.8±1.4 to 3.9±1.2 (p=0.612)).
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hoermandinger', 'Affiliation': 'DHZB Dienstleistungs GmbH, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Krastev', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mulzer', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haese', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'DHZB Dienstleistungs GmbH, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schoenrath', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaufmann', 'Affiliation': 'DHZB Dienstleistungs GmbH, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Knosalla', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Falk', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Potapov', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Knierim', 'Affiliation': 'Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.379']
2764,32465644,The Impact of Pump Speed and Blood Pressure Optimization on Severe Aortic Valve Insufficiency with Left Ventricular Assist Device: A Mock Loop Study.,"PURPOSE


It is cumbersome to medically optimize the RPM setup and afterload adjustment for patients with significant aortic valve insufficiency (AI) with left ventricular assist device (LVAD). Limited amount of information is available regarding the optimal RPM setting or afterload adjustment without adverse effect on the degree of AI.
METHODS


All measurements were performed using a mock circulatory system with a dilated silicone LV model attached to a HeartMateII LVAD (Abbott Labs). Baseline condition was established with 17% ejection fraction, 62 bpm heart rate, LVAD set at 8,800rpm pump flow and 90 mmHg systemic aortic pressure, followed by testing at 8,800 and 9,200 rpm, and two systemic aortic pressure conditions (90 and 80 mmHg at 8,800 rpm). Severe AI was created with a small 3-D printed stent which was nonobstructive to forward flow but prevented the leaflets from fully closing. LVAD, aortic valve and systemic flow were recorded in each situation. Q ratio was calculated with LVAD flow/systemic flow, which represented an efficiency of LVAD flow contribution to the systemic flow.
RESULTS


With the constant circuit afterload at 90mmHg, an RPM increase from 8,800 RPM to 9,200 resulted in systemic flow increase by 21% (2.27 to 2.74 L/min) with a 16% increase in LVAD flow (3.09 to 3.58 L/min), similar aortic valve flow (-0.82 to -0.84 L/min) and improvement in Q ratio (1.36 to 1.31). The regurgitant flow was similar in 8,800 vs. 9,200 (-0.86 vs. -0.83 L/min) in the severe AI setting. With the constant RPM at 8,800, an afterload reduction by 10 mmHg resulted in an increase of the systemic flow by 28% (2.27 to 2.91 L/min) with a LVAD flow increase of 14% (3.09 to 3.52 L/min), aortic valve flow increase of 23% (-0.82 to -0.61 L/min) and improvement in Q ratio (1.36 to 1.21). The alteration in the regurgitant flow was minimal between 90mmHg vs. 80mmHg afterload (-0.86 to -0.81 L/min).
CONCLUSION


Both RPM increase and afterload reduction increased systemic flow and LVAD flow with improved Q ratio. The regurgitant flow stayed constant either with RPM increase or afterload reduction with the fixed regurgitant valve area. This mock-loop study suggests that both afterload reduction and RPM increase should improve systemic flow without increasing the degree of AI after LVAD implant.",2020,"The alteration in the regurgitant flow was minimal between 90mmHg vs. 80mmHg afterload (-0.86 to -0.81 L/min).
","['patients with significant aortic valve insufficiency (AI) with left ventricular assist device (LVAD', 'Severe Aortic Valve Insufficiency with Left Ventricular Assist Device']","['mock circulatory system with a dilated silicone LV model attached to a HeartMateII LVAD (Abbott Labs', 'Pump Speed and Blood Pressure Optimization']","['aortic valve flow increase', 'systemic flow increase', 'similar aortic valve flow', 'afterload reduction', 'regurgitant flow stayed constant either with RPM increase or afterload reduction', 'LVAD flow increase', 'systemic flow and LVAD flow with improved Q ratio', 'LVAD, aortic valve and systemic flow', 'regurgitant flow', 'Q ratio', 'systemic flow', 'LVAD flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C1299322', 'cui_str': 'Aortic valve flow'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1301411', 'cui_str': 'Regurgitant flow'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0475506', 'cui_str': 'Ravens colored progressive matrices'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}]",,0.0268269,"The alteration in the regurgitant flow was minimal between 90mmHg vs. 80mmHg afterload (-0.86 to -0.81 L/min).
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Surgery, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vu', 'Affiliation': 'Biomedical Engineering, San Diego State University, San Diego, CA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fischer', 'Affiliation': 'Surgery, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Surgery, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jocker', 'Affiliation': 'Surgery, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'May-Newman', 'Affiliation': 'Biomedical Engineering, San Diego State University, San Diego, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Surgery, Washington University School of Medicine, St. Louis, MO.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.153']
2765,32465655,Concurrent RVAD Improves Survival for Patients with RV Failure at the Time of LVAD Implantation.,"PURPOSE


Right ventricular (RV) failure is associated with poor outcomes after left ventricular assist device (LVAD) placement. This can be treated with a temporary right ventricular assist device (RVAD), which ideally should be placed before the development of multisystem organ failure. The purpose of this study was to determine if there is any outcome difference in patients who underwent early or concurrent RVAD as compared to delayed RVAD implantation.
METHODS


Via retrospective chart review, 32 patients who received temporary RVAD (30 CentriMag and 2 Protek Duo) were identified between 1/2013 and 7/2018. Subjects were divided into two groups as concurrent RVAD placement (defined as RVAD at the time of LVAD implantation) versus delayed RVAD placement (defined as an RVAD placed at any time after leaving the operating room for the LVAD implant). Survival, ICU and total length of stay (LOS), and total number of days on RVAD were compared utilizing Chi-square and two tailed t-test.
RESULTS


Patients in the concurrent RVAD group had higher preoperative central venous pressure (p = 0.037). Survival rate at three months (χ² = 6.647, p 0.010) and one year (χ² = 3.983, p 0.046) was statistically significantly better among patients who received concurrent LVAD. ICU LOS, total hospital LOS, and number of days on RVAD were not statistically significant between the two groups.
CONCLUSION


Concurrent placement of a temporary RVAD for patients with RV failure at the time of LVAD implantation improves short- and long-term survival post LVAD implantation as compared to a delayed RVAD approach.",2020,"Survival rate at three months (χ² = 6.647, p 0.010) and one year (χ² = 3.983, p 0.046) was statistically significantly better among patients who received concurrent LVAD.","['Patients with RV Failure at the Time of LVAD Implantation', 'patients with RV failure', 'patients who underwent early or concurrent RVAD as compared to delayed RVAD implantation', '32 patients who received temporary RVAD (30 CentriMag and 2 Protek Duo) were identified between 1/2013 and 7/2018']","['concurrent RVAD placement (defined as RVAD at the time of LVAD implantation) versus delayed RVAD placement', 'temporary right ventricular assist device (RVAD', 'left ventricular assist device (LVAD) placement', 'Concurrent RVAD', 'LVAD implantation']","['Survival rate', 'preoperative central venous pressure', 'ICU LOS, total hospital LOS, and number of days on RVAD', 'Survival, ICU and total length of stay (LOS), and total number of days on RVAD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0183046', 'cui_str': 'Right ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0183046', 'cui_str': 'Right ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183046', 'cui_str': 'Right ventricular assist device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",32.0,0.0665911,"Survival rate at three months (χ² = 6.647, p 0.010) and one year (χ² = 3.983, p 0.046) was statistically significantly better among patients who received concurrent LVAD.","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Horstmanshof', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Becker', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Patrick', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'A M El', 'Initials': 'AME', 'LastName': 'Banayosy', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Gorthi', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Cunningham', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Eshelbrenner', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Phancao', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Long', 'Affiliation': 'Advanced Cardiac Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.166']
2766,32465676,Post-Approval Experience with Fully Magnetically Levitated Continuous Flow Left Ventricular Assist Device- Single Center Experience.,"PURPOSE


Overall survival in left ventricular device supported patients has improved due to advancement in device technology. Fully magnetically levitated continuous device (HM3), has shown better hemocompatibility profile. The aim of this study is to compare 1 year survival between patients who received HM3 during the Momentum 3 clinical trial vs. post approval commercial phase.
METHODS


A single center retrospective review of 149 patients undergoing HM3 implant between Aug 2015 -Aug 2019 was carried out. Patients were divided into 2 groups (trial v/s commerical). Patients were compared on their preoperative demographics, medical history, laboratory values, hemodynamics, echo and catheterization records. The primary end point was survival at 1-year. Categorical variables are reported as percentages, whereas continuous variables are reported as mean ± standard deviation (SD), p-value was set at 0.05.
RESULTS


We had 67 (44.97%) patients in the commercial arm vs. 82 (55.03%) in the trial arm. Patients in the commercial arm were younger in age when compared to the trial arm group (50.61 ± 12.81 vs. 55.39 ± 11.54 years, p-0.03). More patients in the commercial arm were implanted as destination therapy (DT) when compared to the trial patients [41 (61.19%) vs. 11 (13.41%), p<0.001]. 83.58% of commercial arm patients were INTERMACS 1 and 2 profile vs. 74.39% (p=0.75) for the trial arm. Other than these two variables, the groups were clinically comparable in terms of their pre-operative conditions and post-operative adverse effects related to surgery. One year survival was 94.7% vs.93.9%) for commercial and trail arm respectively. (p=0.57) (figure 1).
CONCLUSION


Even with higher degree of heart failure (INTERMACS 1 and 2) and comorbid conditions (greater percentage of DT) seen in commercial arm group (reflective of a more real world experience), 1 year survival was similar to a highly controlled trial cohort. Larger multi center studies are required to validate these findings.",2020,One year survival was 94.7% vs.93.9%) for commercial and trail arm respectively.,"['149 patients undergoing HM3 implant between Aug 2015 -Aug 2019 was carried out', 'patients who received HM3 during the Momentum 3 clinical trial vs. post approval commercial phase', 'Patients in the commercial arm were younger in age when compared to the trial arm group (50.61 ± 12.81 vs. 55.39 ± 11.54 years, p-0.03']",[],"['survival at 1-year', 'heart failure', 'One year survival']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0563597', 'cui_str': 'Momentum'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517402', 'cui_str': '0.03'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",149.0,0.091308,One year survival was 94.7% vs.93.9%) for commercial and trail arm respectively.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Akhtar', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.185']
2767,32465678,The Hemodynamic Impact of Mitral Regurgitation on Aortic Insufficiency in the LVAD-Supported Heart.,"PURPOSE


Aortic valve incompetence (AI) is a serious complication that develops in 20% of LVAD patients within 12 months of implantation. Many LVAD patients with AI also develop mitral regurgitation (MR). Our goal in this study was to measure systemic flow (Qsys) and LVAD flow (Q LVAD ) during AI, MR and AI+MR.
METHODS


A mock circulatory loop with a dilated silicone LV and bioprosthetic valves was attached to a HeartMate II LVAD (Abbott Labs), and pressure and flow measured in the LV, LVAD and aorta. A Pre-LVAD ejection fraction of 20% without any valve dysfunction was established, followed LVAD support at speeds of 8, 9.4 and 11krpm. AI and MR were created with small stents that were non-obstructive to forward flow but prevented the leaflets from fully closing. Four conditions were tested: Normal, AI, MR and AI and MR combined. Average flow was obtained from ten cycles of data, and Q calculated as Q LVAD /Qsys.
RESULTS


Pre-LVAD AI, MR and AI+MR produced a 28%, 12% and 45% reduction in Qsys, respectively. LVAD support at 9.4krpm increased Normal Qsys to 3.6 L/min with 95% of flow through the LVAD. MR reduced Qsys by 16% and Q LVAD by 21%; AI reduced by Qsys by 24% but Q LVAD by only 5%; and AI+MR reduced Qsys by 25% and Q LVAD by 7%, which was comparable to AI alone. In all conditions except AI+MR, Q increases with LVAD speed indicating that Q LVAD  increases faster than Qsys. This trend reverses when MR is present, reducing the impact of AI as LVAD speed is increased.
CONCLUSION


The major finding of these studies is that MR does not worsen Qsys when it coincides with AI and LVAD support. AI and MR occur during different phases of the cardiac cycle and sum in the absence of LVAD support. When an LVAD is added without valve dysfunction, Q LVAD is evenly distributed across systole and diastole. AI and MR reduces systolic and increases diastolic Q LVAD , but AI+MR restores the original distribution. AI+MR produces the same overall Qsys but Q LVAD occurs more evenly throughout the cardiac cycle resulting in a greater sensitivity to LVAD speed changes.",2020,"MR reduced Qsys by 16% and Q LVAD by 21%; AI reduced by Qsys by 24% but Q LVAD by only 5%; and AI+MR reduced Qsys by 25% and Q LVAD by 7%, which was comparable to AI alone.",['Many LVAD patients with AI also develop mitral regurgitation (MR'],['LVAD'],"['Normal Qsys', 'AI and MR reduces systolic and increases diastolic Q LVAD', 'systemic flow (Qsys) and LVAD flow (Q LVAD ) during AI, MR and AI+MR', 'MR reduced Qsys', 'Pre-LVAD AI, MR and AI+MR', 'Average flow']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",,0.0306163,"MR reduced Qsys by 16% and Q LVAD by 21%; AI reduced by Qsys by 24% but Q LVAD by only 5%; and AI+MR reduced Qsys by 25% and Q LVAD by 7%, which was comparable to AI alone.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vu', 'Affiliation': 'Bioengineering, San Diego State University, San Diego, CA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Mechanical Circulatory Assist, Washington University, St. Louis, MO.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fischer', 'Affiliation': 'Mechanical Circulatory Assist, Washington University, St. Louis, MO.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Mechanical Circulatory Assist, Washington University, St. Louis, MO.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Mechanical Circulatory Assist, Washington University, St. Louis, MO.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'May-Newman', 'Affiliation': 'Bioengineering, San Diego State University, San Diego, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.188']
2768,32462607,Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO ®  and OTEMTO ®  Studies.,"INTRODUCTION


The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted.
METHODS


TONADO ®  1&2 and OTEMTO ®  1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg tiotropium (LAMA) or 5/5 µg tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI).
RESULTS


Overall, 151 patients received tiotropium; 148 received tiotropium/olodaterol. Mean differences from baseline with tiotropium/olodaterol versus tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV 1 , - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with tiotropium/olodaterol versus tiotropium for trough FEV 1  (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
CONCLUSION


In patients with COPD receiving only LAMA monotherapy, treatment escalation to tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with tiotropium/olodaterol in patients receiving tiotropium alone.
TRIAL REGISTRATION


TONADO ®  1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO ®  2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO ®  1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO ®  2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).",2020,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","['®  2 was registered in the US National Library of Medicine on 10 December 2013', 'patients with COPD receiving only', 'Patients with COPD Receiving only LAMA at Baseline', 'patients receiving tiotropium alone', '®  1 was registered in the US National Library of Medicine on 17 October 2013', 'patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD', 'chronic obstructive pulmonary disease (COPD']","['tiotropium (LAMA) or 5/5\xa0µg tiotropium/olodaterol (LAMA/LABA', 'Tiotropium/Olodaterol', 'muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA', 'tiotropium/olodaterol', 'LAMA monotherapy', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['SGRQ', 'lung function, health status and breathlessness', ""trough forced expiratory volume in 1\xa0s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",,0.511381,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01373-3']
2769,32462791,"Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed SCS Programming in Subjects with Chronic Intractable Back Pain with or Without Leg Pain.","OBJECTIVE


This prospective, open-label, multicenter study evaluated the feasibility of a spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed).
METHODS


Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 ± 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system.
RESULTS


Twenty subjects concluded the study. Mean baseline numerical pain rating score (NPRS) for low back pain was 7.4 with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in NPRS from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. 85% of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS.
CONCLUSION


In this difficult-to-treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study.",2020,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"['Subjects with Chronic Intractable Back Pain with or Without Leg Pain', 'Twenty subjects concluded the study', 'Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States']","['spinal cord stimulation (SCS) therapy programming', 'Differential Target Multiplexed SCS Programming']","['Responder rate for low back pain relief', 'NPRS', 'chronic back pain', 'Mean baseline numerical pain rating score (NPRS', 'back pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",20.0,0.0338046,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, PA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, TX, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Kim', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, PA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Slezak', 'Affiliation': 'Interventional Spine Medicine, Barrington, NH, USA.'}, {'ForeName': 'Ramsin', 'Initials': 'R', 'LastName': 'Benyamin', 'Affiliation': 'Millennium Pain Center, Bloomington, IL, USA.'}, {'ForeName': 'Atiq', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Decatur Memorial Hospital, Decatur, IL, USA.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Millennium Pain Center, Libertyville, IL, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Asteghik', 'Initials': 'A', 'LastName': 'Hacobian', 'Affiliation': 'Interventional Spine Medicine, Barrington, NH, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Griffith', 'Affiliation': 'Precision Spine Care, Tyler, TX, USA.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Millennium Pain Center, Bloomington, IL, USA.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12908']
2770,32462829,Addition of Amlodipine or Valsartan for Improvement of Diastolic Dysfunction Associated with Hypertension.,"BACKGROUND


Hypertensive patients are at increased risk of diastolic dysfunction. The hypothesis of this study was that addition of amlodipine would be superior to valsartan in improving diastolic dysfunction associated with hypertension.
METHODS


In this randomized trial, we randomly assigned 104 controlled, hypertensive patients with diastolic dysfunction to receive either amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy. The primary end point was the change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E') from baseline to the 6-month follow-up. Secondary end points included changes in systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index.
RESULTS


SBP decreased significantly from baseline in both treatment groups (p < 0.001). E/E' decreased significantly from 13.0 ± 2.2 to 12.0 ± 2.7 in the amlodipine arm and from 14.4 ± 4.3 to 12.7 ± 3.7 in the valsartan arm (p < 0.01 in both groups). The change of E/E' was not significantly different between treatment groups (p = 0.25). There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index. Two patients (3.8%) in the amlodipine group and 1 (16%) in the valsartan group had serious adverse event.
CONCLUSIONS


In this randomized trial involving controlled hypertensive patients, addition of amlodipine or valsartan was associated with an improvement of diastolic dysfunction, but the effects on diastolic dysfunction did not differ significantly between the treatment groups.",2020,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","['hypertensive patients with diastolic dysfunction to receive either', 'controlled hypertensive patients', 'Hypertensive patients']","['valsartan', 'amlodipine', 'Amlodipine or Valsartan', 'amlodipine or valsartan', 'amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy']","['diastolic dysfunction', 'SBP, LV mass index, and left atrial volume index', 'Diastolic Dysfunction', 'systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index', 'serious adverse event', 'risk of diastolic dysfunction', 'change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E', 'E/E', 'SBP', 'change of E/E']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C1132897', 'cui_str': 'valsartan 40 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",104.0,0.0345762,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","[{'ForeName': 'Jin Kyung', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jeong Sook', 'Initials': 'JS', 'LastName': 'Seo', 'Affiliation': 'Division of Cardiology, Inje University Busan Paik Hospital, Busan, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Jae Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sahmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Dae Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jong Min', 'Initials': 'JM', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea. dhkang@amc.seoul.kr.'}]",Journal of cardiovascular imaging,['10.4250/jcvi.2020.0005']
2771,32462856,"Effects of essential amino acid supplementation on pain in the elderly with hip fractures: a pilot, double-blind, placebo-controlled, randomised clinical trial.",,2020,,['elderly with hip fractures'],"['essential amino acid supplementation', 'placebo']",['pain'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.620566,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guido', 'Affiliation': 'Epidemiology Unit, Agency for Health Protection of Milan, Milan, Italy.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iannello', 'Affiliation': ""General Management, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'University of Bari, Department of Biomedical Science and Human Oncology, Bari, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'University of Bahrain, Department of Biology, College of Science, Sakhir Campus, Kingdom of Bahrain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Department of Biology and Biotechnology University of Pavia.'}]",Journal of biological regulators and homeostatic agents,['10.23812/19-452-L-46']
2772,32462935,Using Iterative Experimentation to Accelerate Program Improvement: A Case Example.,"BACKGROUND


This article offers a case example of how experimental evaluation methods can be coupled with principles of design-based implementation research (DBIR), improvement science (IS), and rapid-cycle evaluation (RCE) methods to provide relatively quick, low-cost, credible assessments of strategies designed to improve programs, policies, or practices.
OBJECTIVES


This article demonstrates the feasibility and benefits of blending DBIR, IS, and RCE practices with embedded randomized controlled trials (RCTs) to improve the pace and efficiency of program improvement.
RESEARCH DESIGN


This article describes a two-cycle experimental test of staff-designed strategies for improving a workforce development program. Youth enrolled in Year Up's Professional Training Corps (PTC) programs were randomly assigned to ""improvement strategies"" designed to boost academic success and persistence through the 6-month learning and development (L&D) phase of the program, when participants spend most of their program-related time in courses offered by partner colleges.
SUBJECTS


The study sample includes 317 youth from three PTC program sites.
MEASURES


The primary outcome measures are completion of the program's L&D phase and continued college enrollment beyond the L&D phase.
RESULTS


The improvement strategies designed and tested during the study increased program retention through L&D by nearly 10 percentage points and increased college persistence following L&D by 13 percentage points.
CONCLUSION


Blending DBIR, IS, and RCE principles with a multi-cycle RCT generated highly credible estimates of the efficacy of the tested improvement strategies within a relatively short period of time (18 months) at modest cost and with reportedly low burden for program staff.",2020,"The improvement strategies designed and tested during the study increased program retention through L&D by nearly 10 percentage points and increased college persistence following L&D by 13 percentage points.
","[""Up's Professional Training Corps (PTC) programs"", '317 youth from three PTC program sites', 'Youth enrolled in Year']",[],"[""completion of the program's L&D phase and continued college enrollment beyond the L&D phase""]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0296079,"The improvement strategies designed and tested during the study increased program retention through L&D by nearly 10 percentage points and increased college persistence following L&D by 13 percentage points.
","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Maynard', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Baelen', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fein', 'Affiliation': 'Social and Economic Policy, Abt Associates, Rockville, MD, USA.'}, {'ForeName': 'Phomdaen', 'Initials': 'P', 'LastName': 'Souvanna', 'Affiliation': 'Abt Associates, Rockville, MD, USA.'}]",Evaluation review,['10.1177/0193841X20923199']
2773,32462947,Effects of transcranial direct current stimulation on cortex modulation by stimulation of the primary motor cortex and parietal cortex in humans.,"Aim of the study:  Transcranial magnetic stimulation (TMS) is used to measure corticospinal excitability (CSE) from the primary motor cortex (M1) in humans through motor-evoked potentials (MEPs). The variability of CSE responses to transcranial direct current stimulation (tDCS) protocols is high and needs to be reproduced in the healthy population. The M1 and posterior parietal cortex (PPC) are anatomically and functionally connected and could play a role in understanding the variability in CSE responses. We tested the individual MEPs following a common cathodal (ctDCS) protocol over the M1 and PPC. Materials and methods:  Twenty-eight healthy subjects were randomized for a ctDCS stimulation over the left M1 and PPC for 20 min on a separate days. The first dorsal interosseous muscle (FDI) contralateral stimulation of the left M1 was used as the resting motor threshold (RMT), while 15 single pulses 4-8 s apart at an intensity of 120% RMT were used to determine the baseline MEP amplitude and at T0, 5, 10, 20, 30, 40, 50, and 60 min after ctDCS stimulation in both sessions. Results:  A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 (p = 0.046 at M1, p = 0.010 at PPC). Conclusion:  Our results suggested that PPC stimulation can modulate M1 excitability and PPC-M1 connectivity, but a significant effect is only observed immediately post ctDCS. The tDCS showed variability in response to the tDCS protocol is consistent with other non-invasive brain stimulation studies.",2020,"A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 (p = 0.046 at M1, p = 0.010 at PPC).","['Twenty-eight healthy subjects', 'humans']","['transcranial direct current stimulation (tDCS) protocols', 'Transcranial magnetic stimulation (TMS', 'transcranial direct current stimulation']","['M1 excitability and PPC-M1 connectivity', 'corticospinal excitability (CSE']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}]",28.0,0.0346981,"A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 (p = 0.046 at M1, p = 0.010 at PPC).","[{'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Dowihi', 'Initials': 'D', 'LastName': 'Aisha', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamza', 'Affiliation': 'Department of Electrical Engineering, National University of Computer and Emerging Sciences, Lahore, Pakistan.'}, {'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Al-Hussain', 'Affiliation': 'Department Neurology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Woo Kyoung', 'Initials': 'WK', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Hallym University College of Medicine, Anyang, South Korea.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1775594']
2774,32463404,Effects of the apple matrix on the postprandial bioavailability of flavan-3-ols and nutrigenomic response of apple polyphenols in minipigs challenged with a high fat meal.,"Food matrix interactions with polyphenols can affect their bioavailability and as a consequence may modulate their biological effects. The aim of this study was to determine if the matrix and its processing would modulate the bioavailability and the postprandial nutrigenomic response to a dietary inflammatory stress of apple flavan-3-ol monomers. We carried out an acute randomized controlled study in minipigs challenged with a high fat meal (HFM) supplemented with raw fruit, puree, or apple phenolic extract with matched content of flavan-3-ol monomers. Fasting and postprandial blood samples were collected over 3 h to quantify flavan-3-ol monomers in sera by UPLC-Q-TOF/MS and to isolate peripheral blood mononuclear cells (PBMCs) for assessing the changes in the gene expression profile using a microarray analysis. When compared to the extract-supplemented meal, the peak of the total flavan-3-ol concentration was reduced by half with both raw apple and puree supplements. The apple matrices also affected the gene expression profile as revealed by the Principal Component Analysis of the microarray data from PBMCs which discriminated the supplementation of HFM with the polyphenol extract from those with raw apples or puree. A total of 309 genes were identified as differentially expressed by the apple-derived products compared to HFM, with 63% modulated only in the presence of the food matrix (apple and puree). The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182). Pathway enrichment analyses revealed that genes affected by the apple-derived products control inflammation and leukocyte transendothelial migration both involved in the onset of atherosclerotic processes. Overall, this study showed that the two apple matrices reduce the postprandial serum concentration of flavon-3-ols whereas they increase the nutrigenomic response of PBMCs. The biological processes identified as modulated by the apple products suggest an attenuation of the transient pro-inflammatory response induced by a HFM. The differences observed between the nutrigenomic responses support that the apple matrix and its processing affect the nutrigenomic response, probably by increasing the bioavailability of other apple phytochemicals. To conclude, this study raises awareness for considering the impact of the food matrix and its processing on the biological response of polyphenols in nutritional studies.",2020,The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182).,['minipigs challenged with a high fat meal'],"['apple matrix', 'high fat meal (HFM) supplemented with raw fruit, puree, or apple phenolic extract']","['total flavan-3-ol concentration', 'postprandial bioavailability of flavan-3-ols and nutrigenomic response', 'postprandial serum concentration of flavon-3-ols', 'Fasting and postprandial blood samples', 'nutrigenomic response of PBMCs']","[{'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0912567', 'cui_str': 'flavan-3-ol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1956006', 'cui_str': 'Nutritional Genomics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0060440', 'cui_str': 'flavone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",309.0,0.0226814,The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182).,"[{'ForeName': 'Laurent-Emmanuel', 'Initials': 'LE', 'LastName': 'Monfoulet', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buffière', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Istas', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College, London, UK.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dufour', 'Affiliation': ""INRAE, Université d'Avignon, UMR408, Sécurité et Qualité des Produits d'Origine Végétale (SQPOV), Avignon, 84000, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Le Bourvellec', 'Affiliation': ""INRAE, Université d'Avignon, UMR408, Sécurité et Qualité des Produits d'Origine Végétale (SQPOV), Avignon, 84000, France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Mercier', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bayle', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Boby', 'Affiliation': 'INRAE, Unité Mixte de Recherches sur les Herbivores, Clermont-Ferrand, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Remond', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Borel', 'Affiliation': 'C2VN, INRAE, INSERM, Aix Marseille Université, F-13005, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Mateos', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College, London, UK.""}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Milenkovic', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Morand', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}]",Food & function,['10.1039/d0fo00346h']
2775,32463430,Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial.,"Importance


Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age.
Objective


To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.
Design, Setting, and Participants


This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.
Interventions


Adenotonsillectomy.
Main Outcomes and Measures


The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses. Polysomnography and the OSA-18 questionnaire were completed at baseline and after 6 months.
Results


Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA-18 questionnaire (eg, total OSA-18 score: -17; 95% CI, -24 to -10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (-3.1; 95% CI, -5.7 to -0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline.
Conclusions and Relevance


This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.
Trial Registration


ClinicalTrials.gov Identifier: NCT02315911.",2020,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","['With Mild to Moderate Obstructive Sleep Apnea', 'children between 2 and 4 years of age', '60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n\u2009=\u200929) or', 'healthy children with mild to moderate OSA.\nDesign, Setting, and Participants', 'A total of 53 participants (88%; ATE, n\u2009=\u200925; watchful waiting, n\u2009=\u200928) completed the study', '60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months', 'December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden', 'Young Children', 'Data were analyzed from August 2018 to December 2018', 'children with obstructive sleep apnea (OSA']","['Adenotonsillectomy vs Watchful Waiting', 'Adenotonsillectomy (ATE', 'ATE', 'watchful waiting']","['quality of life', 'polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses', 'mean OAHI score change', 'mean OAHI score', 'Polysomnography and the OSA-18 questionnaire', 'OSA-18 questionnaire']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.10545,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Browaldh', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.0869']
2776,32463456,Effect of Osimertinib and Bevacizumab on Progression-Free Survival for Patients With Metastatic EGFR-Mutant Lung Cancers: A Phase 1/2 Single-Group Open-Label Trial.,"Importance


The combination of erlotinib and bevacizumab as initial treatment of epidermal growth factor receptor (EGFR [OMIM 131550])-mutant lung cancers improves progression-free survival (PFS) compared with erlotinib alone. Because osimertinib prolongs PFS compared with erlotinib, this trial was designed to study the combination of osimertinib and bevacizumab as first-line treatment.
Objectives


To determine the safety and tolerability of osimertinib and bevacizumab combination treatment and assess the 12-month PFS of the combination in patients with metastatic EGFR-mutant lung cancers.
Design, Setting, and Particiants


From August 15, 2016, to May 15, 2018, 49 patients with metastatic EGFR-mutant lung cancers were enrolled in this interventional clinical trial, conducted at a single academic cancer center. In the phase 1 portion of the study, a standard 3 + 3 dose de-escalation design was used to determine the maximum tolerated dose of osimertinib and bevacizumab. In the phase 2 portion of the study, patients were treated at the maximum tolerated dose defined in the phase 1 portion. Statistical analysis was performed from August 1 to October 1, 2019.
Interventions


All patients received osimertinib, 80 mg daily, and bevacizumab, 15 mg/kg once every 3 weeks.
Main Outcomes and Measures


The primary objective of the phase 2 portion of the study was to determine the number of patients receiving the combination of osimertinib and bevacizumab who were progression free at 12 months. Secondary end points included overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment.
Results


Among the 49 patients in the study (34 women; median age, 60 years [range, 36-83 years]), PFS at 12 months was 76% (95% CI, 65%-90%). The overall response rate was 80% (95% CI, 67%-91%), and median PFS was 19 months (95% CI, 15-24 months). Of the 6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response. Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002). Identified mechanisms of resistance included squamous cell transformation (n = 2) pleomorphic transformation (n = 1), and acquired EGFR L718Q (n = 1) and C797S (n = 1) mutations.
Conclusions and Relevance


The combination of osimertinib and bevacizumab met the study's prespecified effectiveness end point. Persistent EGFR-mutant circulating tumor DNA at 6 weeks was associated with early progression and shorter survival. A randomized phase 3 study comparing osimertinib and bevacizumab with osimertinib alone is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT02803203.",2020,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","['patients with metastatic EGFR-mutant lung cancers', '6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response', '49 patients in the study (34 women; median age, 60 years [range, 36-83 years', '49 patients with metastatic EGFR-mutant lung cancers', 'Patients With Metastatic EGFR-Mutant Lung Cancers']","['Osimertinib and Bevacizumab', 'erlotinib and bevacizumab', 'osimertinib and bevacizumab', 'bevacizumab']","['early progression and shorter survival', 'overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment', 'safety and tolerability', 'median overall survival (clearance', 'median PFS (clearance', 'overall response rate', 'Progression-Free Survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",49.0,0.125856,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","[{'ForeName': 'Helena A', 'Initials': 'HA', 'LastName': 'Yu', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Makhnin', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Rizvi', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tsui', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Falcon', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Houck-Loomis', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Fanli', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Julie Li', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Tobi', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ahn', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hayes', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Arcila', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Chaft', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ladanyi', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Riely', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kris', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1260']
2777,32463470,Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial.,"Importance


Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed.
Objective


To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type.
Design, Setting, and Participants


This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019.
Interventions


Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study.
Main Outcomes and Measures


Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks.
Results


A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups.
Conclusions and Relevance


Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
Trial Registration


EU Clinical Trials Register Identifier: 2007-005352-17.",2020,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","['Apathy in Alzheimer Disease', '108 patients (mean [SD] age, 74.8 [5.9] years', 'Patients with additional clinically relevant depressed mood were excluded', 'psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany', ' 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive', 'patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood', 'Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included', 'patients with dementia of Alzheimer type']","['Bupropion', 'dopamine and noradrenaline reuptake inhibitor bupropion', 'donepezil or galantamine', 'bupropion or placebo', 'bupropion', 'placebo']","['AES-C score', 'numbers of adverse events', 'health-related quality of life', 'total neuropsychiatric symptoms', 'neuropsychiatric symptoms, cognition, activities of daily living, and quality of life', 'Apathy Evaluation Scale-Clinician Version (AES-C', 'efficacy and safety', 'serious adverse events', 'baseline AES-C score', 'cognition', 'activities of daily living']","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",108.0,0.521266,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Spottke', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Bach', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Buerger', 'Affiliation': 'Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dodel', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fellgiebel', 'Affiliation': 'Center for Mental Health in Old Age, Landeskrankenhaus, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fliessbach', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Frölich', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Hausner', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Klostermann', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kornhuber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Laske', 'Affiliation': 'German Center for Neurodegenerative Diseases, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Richter-Schmidinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Kija', 'Initials': 'K', 'LastName': 'Shah-Hosseini', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases, Rostock, Germany.'}, {'ForeName': 'Christine A F', 'Initials': 'CAF', 'LastName': 'von Arnim', 'Affiliation': 'Department of Neurology, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiltfang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6027']
2778,32447859,[Anatomic study on safe insertion of acupuncture needle in Qiuhou (EX-HN7) acupoint].,"OBJECTIVE


To explore the anatomical structure of acupuncture point Qiuhou (EX-HN7) area for safe insertion of acupuncture needle.
METHODS


A total of 28 orbital specimens of adult corpses (14 men and 14 women) were randomly selected to be observed by anatomical sectioning and layering methods. The acupoint EX-HN7, located at the junction between the 1/4 of the outer boundary and 3/4 of the inner boundary of the infraorbital margin according to the ""Standardization of Acupoint Position"" implemented by the People's Republic of China, and marked first with a color pen, followed by cutting the head into horizontal sections along the cross line by using a cadaver cutter and measuring the distance between the skin and blood vessels and main nerves with a digimatic caliper. When the anatomic hierarchy was performed, the blood vessels and nerves in the orbit, the morphological characteristics of the structure around the needle body were particularly focused.
RESULTS


When an acupuncture needle was vertically inserted into EX-HN7 region, the tissues through which the needle passes are skin, subcutaneous tissue, orbicularis muscle, orbital adipose body, inferior oblique muscle and inferior orbital wall, respectively. When an acupuncture needle was inserted obliquely upward and along the inferior orbital wall to a depth of (26.5±1.7)mm, the needle tip met the posterior ciliary artery; when to a depth of (41.4±1.3)mm, it reached the superior ophthalmic vein. When inserted to a depth of (40.4±1.5)mm, the needle tip may damage the ophthalmic artery and optic nerve. When the acupuncture needle was inserted inferiorly and closely along the orbital inferior wall to a depth of (13.2±1.4)mm, the infraorbital artery in the suborbital sulcus would be hurt.
CONCLUSION


It is recommended that when insert vertically into a depth of 12.0 mm in EX-HN7, the acupuncture needle tip should be slightly inclined inward and posterior-upward, and the depth should not exceed 26.0 mm.",2020,"When inserted to a depth of (40.4±1.5)mm, the needle tip may damage the ophthalmic artery and optic nerve.",['28 orbital specimens of adult corpses (14 men and 14 women'],"['acupuncture needle in Qiuhou (EX-HN7) acupoint', 'acupuncture point Qiuhou (EX-HN7']",[],"[{'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]",[],28.0,0.0292238,"When inserted to a depth of (40.4±1.5)mm, the needle tip may damage the ophthalmic artery and optic nerve.","[{'ForeName': 'Zhao-Wen', 'Initials': 'ZW', 'LastName': 'Wei', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Si-Ning', 'Initials': 'SN', 'LastName': 'Li', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190431']
2779,32459597,Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer.,"PURPOSE


Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC.
METHODS


Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13.
RESULTS


Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5%  v  8.2%; ABCP, 48.6%  v  21.2%; BCP, 44.7%  v  11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly.
CONCLUSION


ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.",2020,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","['Non-Small-Cell Lung Cancer', 'chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC', 'Patients']","['Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy', 'Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP', 'atezolizumab to chemotherapy with and without bevacizumab', 'ABCP', 'bevacizumab, carboplatin, and paclitaxel (BCP', 'atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP']","['incidence of serious AEs (SAEs', 'Completion rates of the PRO questionnaires', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13', 'global health status or physical functioning scores', 'incidence, nature, and severity of adverse events (AEs', 'overall survival and investigator-assessed progression-free survival', 'Treatment tolerability']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.253518,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Evangelisches Krankenhaus Hamm gGmbH, Hamm, Germany.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Orlandi', 'Affiliation': 'Instituto Nacional del Tórax, Santiago, Chile.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer & Research Center, Chandler, AZ.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'González Larriba', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rothenstein', 'Affiliation': 'Durham Regional Cancer Center, Lakeridge Health, Oshawa, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Cantonal Hospital of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Shankar', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kelsch', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03158']
2780,32459600,"ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia.","PURPOSE


Acalabrutinib, a highly selective, potent, Bruton tyrosine kinase inhibitor, was evaluated in this global, multicenter, randomized, open-label, phase III study in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).
METHODS


Eligible patients, aged ≥ 18 years with R/R CLL, were randomly assigned 1:1 centrally and stratified by del(17p) status, Eastern Cooperative Oncology Group performance status score, and number of prior lines of therapy. Patients received acalabrutinib monotherapy or investigator's choice (idelalisib plus rituximab [I-R] or bendamustine plus rituximab [B-R]). The primary end point was progression-free survival (PFS) assessed by an independent review committee (IRC) in the intent-to-treat population. Key secondary end points included IRC-assessed overall response rate, overall survival, and safety.
RESULTS


From February 21, 2017, to January 17, 2018, a total of 398 patients were assessed for eligibility; 310 patients were randomly assigned to acalabrutinib monotherapy (n = 155) or investigator's choice (n = 155; I-R, n = 119; B-R, n = 36). Patients had received a median of two prior therapies (range, 1-10). After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator's choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49];  P  < .0001). Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator's choice. Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
CONCLUSION


Acalabrutinib significantly improved PFS compared with I-R or B-R and has an acceptable safety profile in patients with R/R CLL.",2020,"Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
","['Relapsed or Refractory Chronic Lymphocytic Leukemia', 'Eligible patients, aged ≥ 18 years with R/R CLL', '398 patients were assessed for eligibility; 310 patients', 'patients with R/R CLL', 'patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL', 'From February 21, 2017, to January 17, 2018']","['Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab', ""acalabrutinib monotherapy or investigator's choice (idelalisib plus rituximab [I-R] or bendamustine plus rituximab [B-R"", 'del(17p', 'acalabrutinib monotherapy']","['performance status score, and number of prior lines of therapy', 'PFS', 'Serious adverse events', 'progression-free survival (PFS) assessed by an independent review committee (IRC', 'Estimated 12-month PFS', 'IRC-assessed overall response rate, overall survival, and safety', 'median PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",398.0,0.249092,"Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Szpital Specjalistyczny w Brzozowie im. Ks. Markiewicza, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku, Brzozow, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wach', 'Affiliation': 'Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lysak', 'Affiliation': 'Fakultní Nemocnice Plzeň, Pilsen, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kozak', 'Affiliation': 'Fakultní Nemocnice Královske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Simkovic', 'Affiliation': 'University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Kaplan', 'Affiliation': 'Dnipropetrovsk City Clinical Hospital No. 4, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Kraychok', 'Affiliation': 'National Cancer Institute, Kiev, Ukraine.'}, {'ForeName': 'Arpad', 'Initials': 'A', 'LastName': 'Illes', 'Affiliation': 'University of Debrecen, Faculty of Medicine, Department of Hematology, Debrecen, Hungary.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Dolan', 'Affiliation': 'Saint John Regional Hospital, University of New Brunswick, St John, New Brunswick, Canada.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Campbell', 'Affiliation': 'Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Musuraca', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'Royal Wolverhampton Hospital National Health Service Trust, Wolverhampton, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Nebraska Hematology Oncology, Lincoln, NE.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Quah', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03355']
2781,32459631,Mobile Delivery of the Diabetes Prevention Program in People with Pre-diabetes: A Randomized Controlled Trial.,"BACKGROUND


To date, no randomized controlled trial has verified the efficacy of a fully mobile version of the diabetes prevention program (DPP).
OBJECTIVE


This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care.
METHODS


Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP or to a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) at 6 and 12 months. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c.
RESULTS


A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In intention-to-treat (ITT) analyses, change in the participants' weight and BMI was significantly different at 6 months in the intervention and control groups by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively, but HbA1c was not (0.004%; SE 0.05; P=.94). These differences persisted at 12 months. However, in analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention who did not start the program had no meaningful weight or HbA1c change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c; those who completed the intervention had a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c.
CONCLUSIONS


A novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions.
CLINICALTRIAL


Clinicaltrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.",2020,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"['People with Pre-diabetes', '202 participants were recruited and randomized into the intervention (n=101) or control group (n=99', 'Adults with prediabetes (N=202']","['control group receiving usual medical care', 'mobile-delivered, coach-guided DPP or to a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention', 'Mobile Delivery of the Diabetes Prevention Program', 'mobile-delivered DPP']","['risk of overt diabetes', 'HbA1c', 'program engagement as a predictor of changes in weight and HbA1c', 'weight loss', 'weight and BMI', 'weight loss reductions', 'glycemic efficacy', 'changes in weight and hemoglobin A1c (HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",202.0,0.118825,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'Noom, Inc., 229 W 28th St, New York, US.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michaelides', 'Affiliation': 'Noom, Inc., 229 W 28th St, New York, US.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anton', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Zulekha', 'Initials': 'Z', 'LastName': 'Karim', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Kang-Oh', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Argyrou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Loukaidou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Charitou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Sze', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, US.'}]",JMIR mHealth and uHealth,['10.2196/17842']
2782,32459635,Promoting employees' recovery during shift work: protocol for a workplace intervention study.,"BACKGROUND


Shift work can be demanding due to disturbances of biological and social rhythms. This can cause short-term negative effects for employees, such as increased levels of fatigue and reduced alertness. A potential way to counteract these negative effects is to enhance employees' recovery from work during working hours.
OBJECTIVE


The aim of this study is to develop and implement an intervention that focuses on promoting 'on-job' recovery of shift workers.
METHODS


The study takes place at a multinational company within the steel industry. For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation. This approach consists of various sessions in which employees and a project group (i.e., researchers, line managers, human resources (HR) managers, occupational health experts) provide input on intervention content and implementation. Intervention effects will be evaluated by means of pre-test and post-test online surveys. Digital Ecological Momentary Assessment (EMA) will be used to gain insight in the link between the intervention and daily within-person processes. The intervention process and participants perception of the interventions will be assessed through a process evaluation. Intervention results will be analyzed performing mixed model repeated measures analyses (MANOVA) and multilevel analyses.
RESULTS


The study was funded and started in 2018. In 2019, baseline and follow-up data have been collected. Data-analysis is planned for Q1-Q2 2020. Dissemination of the results is planned for Q3-Q4 2020.
CONCLUSIONS


A strength of this study design is the participatory action approach (PAR) to enhance commitment of all stakeholders, intervention adherence and compliance. Moreover, due to target group participation in development and implementation of the interventions, the proposed impact will be more likely to occur. In addition, short-term as well as longer-term effects will be evaluated. Finally, this study uses a unique combination of quantitative and qualitative evaluation methods. The impossibility to randomly assign participants to an intervention or control group is a limitation of this study. Furthermore, the follow-up period (6 months) might be too short to establish health-related effects. Lastly, the results of this study might be specific to the department, organization, or sector, which limits generalizability. However, as workplace intervention research for shift workers is scarce, this study might serve as a starting point for future research on shift work interventions.",2020,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.",[],['Digital Ecological Momentary Assessment (EMA'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",[],,0.0487991,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.","[{'ForeName': 'Irene Mw', 'Initials': 'IM', 'LastName': 'Niks', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'van Drongelen', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}, {'ForeName': 'Elsbeth M', 'Initials': 'EM', 'LastName': 'de Korte', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}]",JMIR research protocols,['10.2196/17368']
2783,32465801,Gaseous Nitric Oxide (gNO) as a Potential Antimicrobial Therapy during Ex Vivo Lung Perfusion: An Efficacy and Safety Study.,"PURPOSE


Microbial infection in donor lungs decreases organ utilization in transplantation. Previous studies have demonstrated high-dose gaseous Nitric Oxide (gNO) to be effective against bacteria, however, this concept has not been studied in the context of lung transplantation. The present study explores the antimicrobial effects and the safety of continuously inhaled high-dose gNO.
METHODS


Effects of gNO on strains of P. aeruginosa, S. aureus, E. coli and Burkholderia cepacia (purchased from American Type Culture Collection) were performed in vitro. Agar plates were inoculated and transferred into either control (medical air) or treatment chamber (medical air + 200 ppm gNO) for 6 h. Safety of continuously inhaled high-dose gNO were studied in a porcine normothermic ex vivo lung perfusion (EVLP) model. Donor lungs with minimal cold ischemia (2h) were randomized (n=4 each) into control (normal ventilation setting) and treatment (normal ventilation setting + high-dose of gNO) group. Physiologic and biologic measures were monitored over 12 h of EVLP.
RESULTS


gNO significantly reduced all strains of bacteria when compared to control (n=3 per group, Fig.1A): P. aeruginosa (5.8 ±1.27 vs 9.2 ±0.40 Log 10 CFU/mL, p= 0.01), S. aureus (5.6 ±0.65 vs 9.1 ±0.66 Log 10 CFU/mL, p= 0.002), E. coli (5.3 ±1.20 vs 9.4 ±0.47 Log 10 CFU/mL, p= 0.005) and Burkholderia cepacia (7.0 ±0.51 vs 8.9 ±0.57 Log 10 CFU/mL, p= 0.01). No significant adverse effects in lung function during EVLP were observed in lungs receiving 12h of continuous high-dose of gNO (Fig. 1B). Inflammatory cytokines at 1, 6 and 12h were similar between control and treatment (Fig. 1C). NO 2  levels were <2.8 ppm throughout the treatment.
CONCLUSION


Continuous high dose gNO at 200 ppm is effective towards reducing common respiratory pathogens in vitro. Inhaled high-dose gNO appears to be safe during 12h EVLP. We are further exploring this treatment using infected human lungs. If successful high dose gNO could be part of EVLP clinical protocols.",2020,"RESULTS


gNO significantly reduced all strains of bacteria when compared to control (n=3 per group, Fig.1A): P. aeruginosa (5.8 ±1.27 vs 9.2 ±0.40","['infected human lungs', 'Donor lungs with minimal cold ischemia (2h']","['Gaseous Nitric Oxide (gNO', 'gNO', 'control (normal ventilation setting) and treatment (normal ventilation setting\u202f+\u202fhigh-dose of gNO', 'porcine normothermic ex vivo lung perfusion (EVLP) model', 'control (medical air) or treatment chamber (medical air\u202f+\u202f200 ppm gNO']","['Physiologic and biologic measures', 'Burkholderia cepacia', 'strains of bacteria', 'Inflammatory cytokines']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0524360', 'cui_str': 'Donor for lung transplant'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1563921', 'cui_str': 'Cold Ischemia'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439187', 'cui_str': 'ppm'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0085469', 'cui_str': 'Burkholderia cepacia'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.0296902,"RESULTS


gNO significantly reduced all strains of bacteria when compared to control (n=3 per group, Fig.1A): P. aeruginosa (5.8 ±1.27 vs 9.2 ±0.40","[{'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Michaelsen', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vp Ribeiro', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wannberg', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pires', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Del Sorbo', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ramadan', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gomes', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galasso', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brambate', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gazzalle', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Thoracic Surgery, UHN, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1217']
2784,31866529,Effect of frequency of sensor use on glycaemic control in individuals on sensor-augmented pump therapy with and without Predictive Low Glucose Management System.,"Improved frequency of sensor use improves glycaemic control. Furthermore, there is no deterioration of glycaemic control with increased sensor use in individuals on Predictive Low Glucose Management (PLGM) system. Younger children are more likely to have better sensor uptake than older children.",2020,Younger children are more likely to have better sensor uptake than older children.,"['individuals on sensor-augmented pump therapy with and without Predictive Low Glucose Management System', 'Younger children']",[],['glycaemic control'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0158803,Younger children are more likely to have better sensor uptake than older children.,"[{'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Abraham', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia; Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia; Division of Paediatrics, within the Medical School, The University of Western Australia, Perth, Australia. Electronic address: Mary.Abraham@health.wa.gov.au.""}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'Smith', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Nicholas', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia; Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Fairchild', 'Affiliation': ""Department of Endocrinology and Diabetes, Women's and Children's Hospital, Adelaide, Australia.""}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': ""Department of Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Ambler', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, The University of Sydney, Sydney, Australia.""}, {'ForeName': 'Fergus J', 'Initials': 'FJ', 'LastName': 'Cameron', 'Affiliation': ""Department of Endocrinology and Diabetes, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia; Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia; Division of Paediatrics, within the Medical School, The University of Western Australia, Perth, Australia.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia; Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia; Division of Paediatrics, within the Medical School, The University of Western Australia, Perth, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia; Department of Endocrinology and Diabetes, Women's and Children's Hospital, Adelaide, Australia; Department of Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia; Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, The University of Sydney, Sydney, Australia; Department of Endocrinology and Diabetes, Royal Children's Hospital, Melbourne, Australia.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2019.107989']
2785,32468955,Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial.,"PURPOSE


In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.
PATIENTS AND METHODS


Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease.
RESULTS


There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48;  P  < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85;  P  = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
CONCLUSION


In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.",2020,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","['patients with HER2-positive breast cancer', 'Patients', 'Previously Treated HER2-Positive Breast Cancer', 'participants with BMs', 'patients with HER2-positive breast cancer with BMs', '291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm', 'patients with measurable intracranial disease', 'patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs']","['baseline brain magnetic resonance imaging', 'Tucatinib Plus Trastuzumab and Capecitabine', 'tucatinib or placebo, in combination with trastuzumab and capecitabine']","['risk of intracranial progression or death', 'Risk of death', 'ORR-IC', 'Median OS', 'risk of death', 'intracranial efficacy and survival', 'Median CNS-PFS', 'Intracranial Efficacy and Survival', 'intracranial objective response rate (ORR-IC', 'antitumor activity against BMs', 'CNS-PFS (intracranial progression or death) and overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]",291.0,0.139198,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","[{'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Anders', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology-Nashville, Nashville, TN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles Medical Center/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'Royal Marsden National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Hospital Universitario Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Zelnak', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'DiGiovanna', 'Affiliation': 'Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Regan"", 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'Christie NHS Foundation Trust, Manchester Academic Health Science Centre & Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Providence Cancer Institute, Portland, OR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Cancer Research Centre, Edinburgh, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, University of Milano, Milan, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer-Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'JoAl', 'Initials': 'J', 'LastName': 'Mayor', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGoldrick', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Xuebei', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00775']
2786,32468956,"Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study.","PURPOSE


Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC.
METHODS


Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided  P  = .0048 for PFS and .0128 for OS.
RESULTS


Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98;  P  = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%.
CONCLUSION


Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.",2020,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","['453 participants', 'patients with ES-SCLC', 'patients with small-cell lung cancer (SCLC', 'Extensive-Stage Small-Cell Lung Cancer', 'Eligible patients', 'patients with previously untreated extensive-stage (ES) SCLC']","['Pembrolizumab or Placebo Plus Etoposide and Platinum', 'pembrolizumab plus EP', 'placebo plus EP', 'Pembrolizumab plus EP', 'pembrolizumab 200 mg once every 3 weeks or saline placebo', 'pembrolizumab plus EP and placebo plus EP', 'Pembrolizumab monotherapy', 'pembrolizumab plus etoposide and platinum (EP) with placebo plus EP']","['PFS', 'Objective response rate (ORR) and duration of response', 'toxicities', 'ORR', 'progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",453.0,0.588583,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Rudin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Gottfried', 'Affiliation': 'Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Hetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary.'}, {'ForeName': 'Parneet K', 'Initials': 'PK', 'LastName': 'Cheema', 'Affiliation': 'William Osler Health System, University of Toronto, Brampton, Ontario, Canada.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Wollner', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Orlandi', 'Affiliation': 'Oncología-Health and Care, Santiago, Chile.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Kalemkerian', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00793']
2787,32468992,Effect of a Single Session of Facial Distortion Model Manual Physiotherapy and a Selected Foam Rolling Technique on Treatment Outcomes in Cervical Spine Overload. Pilot Study.,"BACKGROUND


The prevalence of neck pain is on the increase. A sedentary life style, poor ergonomics in the workplace and in daily life, and stress all contribute to neck overload. The aim of this study was to assess the efficacy of a single session of a Fascial Distortion Model (FDM) intervention combined with foam rolling in patients with cervical spine overload.
MATERIAL AND METHODS


The study enrolled 90 patients, who were randomized to an FDM group, a foam rolling group (who exercised with a Duoball against a wall) and a control group, of 30 patients each. Mobility was measured with a digital inclinometer, pain intensity was assessed with a VAS scale and (upper and middle) trapezius tone was evaluated by sEMG. These measurements were carried out twice in each group and analysed in Matlab and Statistica 13.
RESULTS


Both groups subjected to a therapeutic intervention (FDM and foam rolling) reported a significant reduction in neck pain intensity and improved cervical spine mobility (p&lt;0.01). The control group did not demonstrate changes in mobility or pain intensity. The resting trapezius tone did not change in any of the groups. Conclusions, 1. A single session of FDM therapy can effectively reduce and eliminate cervical spine pain, which may be of use in work-site rehabilitation. 2. Single sessions of FDM and foam rolling can effectively improve neck mobility in patients with cervical spine overload. 3. There is a rationale for conducting further prospective randomized studies of larger samples to assess the duration of the beneficial effects of both therapies and determine an optimum session frequency.",2020,Both groups subjected to a therapeutic intervention (FDM and foam rolling) reported a significant reduction in neck pain intensity and improved cervical spine mobility (p&lt;0.01).,"['Cervical Spine Overload', '90 patients', 'patients with cervical spine overload']","['FDM and foam rolling', 'FDM therapy', 'FDM', 'Facial Distortion Model Manual Physiotherapy and a Selected Foam Rolling Technique', 'foam rolling group (who exercised with a Duoball against a wall', 'therapeutic intervention (FDM and foam rolling', 'Fascial Distortion Model (FDM) intervention combined with foam rolling']","['trapezius tone', 'neck pain intensity and improved cervical spine mobility', 'VAS scale and (upper and middle', 'resting trapezius tone', 'neck mobility', 'Mobility', 'digital inclinometer, pain intensity', 'cervical spine pain', 'mobility or pain intensity']","[{'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0423674', 'cui_str': 'Pain in cervical spine'}]",90.0,0.0306176,Both groups subjected to a therapeutic intervention (FDM and foam rolling) reported a significant reduction in neck pain intensity and improved cervical spine mobility (p&lt;0.01).,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wiaderna', 'Affiliation': 'Zakład Rehabilitacji, Wydział Medyczny, Warszawski Uniwersytet Medyczny, Polska / Division of Rehabilitation, Faculty of Medical Sciences , Medical University of Warsaw, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Selegrat', 'Affiliation': 'Zakład Rehabilitacji, Wydział Medyczny, Warszawski Uniwersytet Medyczny, Polska / Division of Rehabilitation, Faculty of Medical Sciences , Medical University of Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hadamus', 'Affiliation': 'Zakład Rehabilitacji, Wydział Medyczny, Warszawski Uniwersytet Medyczny, Polska / Division of Rehabilitation, Faculty of Medical Sciences , Medical University of Warsaw, Poland.'}]","Ortopedia, traumatologia, rehabilitacja",['10.5604/01.3001.0014.1184']
2788,32468989,An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT.,"BACKGROUND


There is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers.
OBJECTIVE


To determine the clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS).
DESIGN


A pragmatic, observer-blind, parallel-group, multicentre randomised controlled trial with embedded health economic and process evaluations. Participants were randomised (1 : 1) to receive EXTRAS or usual care.
SETTING


Nineteen NHS study centres.
PARTICIPANTS


Patients with a new stroke who received early supported discharge and their informal carers.
INTERVENTIONS


Five EXTRAS reviews provided by an early supported discharge team member between 1 and 18 months post early supported discharge, usually over the telephone. Reviewers assessed rehabilitation needs, with goal-setting and action-planning. Control treatment was usual care post early supported discharge.
MAIN OUTCOME MEASURES


The primary outcome was performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post randomisation. Secondary outcomes at 12 and 24 months included patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events. For carers, secondary outcomes included carers' strain (Caregiver Strain Index) and experience of services. Cost-effectiveness was estimated using resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years.
RESULTS


A total of 573 patients (EXTRAS,  n  = 285; usual care,  n  = 288) with 194 carers (EXTRAS,  n  = 103; usual care,  n  = 91) were randomised. Mean 24-month Nottingham Extended Activities of Daily Living Scale scores were 40.0 (standard deviation 18.1) for EXTRAS ( n  = 219) and 37.2 (standard deviation 18.5) for usual care ( n  = 231), giving an adjusted mean difference of 1.8 (95% confidence interval -0.7 to 4.2). The mean intervention group Hospital Anxiety and Depression Scale scores were not significantly different at 12 and 24 months. The intervention did not improve patient health status or carer strain. EXTRAS patients and carers reported greater satisfaction with some aspects of care. The mean cost of resource utilisation was lower in the intervention group: -£311 (95% confidence interval -£3292 to £2787), with a 68% chance of EXTRAS being cost-saving. EXTRAS was associated with 0.07 (95% confidence interval 0.01 to 0.12) additional quality-adjusted life-years. At current conventional thresholds of willingness to pay for a quality-adjusted life-year, there is a 90% chance that EXTRAS is cost-effective.
CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services. Given the impact on costs and quality-adjusted life-years, there is a high chance that EXTRAS could be considered cost-effective.
FUTURE WORK


Further research is required to identify whether or not community-based interventions can improve performance of extended activities of daily living, and to understand the improvements in health-related quality of life and costs seen by provision of intermittent longer-term specialist review.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN45203373.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 24. See the NIHR Journals Library website for further project information.",2020,"CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services.","['573 patients (EXTRAS,  n \u2009=\u2009285; usual care,  n \u2009=\u2009288) with 194 carers (EXTRAS,  n \u2009=\u2009103; usual care,  n \u2009=\u200991', 'Patients with a new stroke who received early supported discharge and their informal carers', 'Nineteen NHS study centres', 'people who have had a stroke']","['EXTRAS', 'extended stroke rehabilitation service (EXTRAS', 'EXTRAS or usual care']","[""stroke survivors' performance"", 'Cost-effectiveness', 'patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events', 'clinical effectiveness and cost-effectiveness', 'mean cost of resource utilisation', 'performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale', 'Nottingham Extended Activities of Daily Living Scale scores', 'patient health status or carer strain', 'mean intervention group Hospital Anxiety and Depression Scale scores', ""carers' strain (Caregiver Strain Index) and experience of services"", 'resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",573.0,0.212998,"CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nawaraj', 'Initials': 'N', 'LastName': 'Bhattarai', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Cant', 'Affiliation': 'Service user, c/o Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': ""School of Health Sciences, Medical School, Queen's Medical Centre, University of Nottingham, Nottingham, UK.""}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Hills', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Laverty', 'Affiliation': 'Stroke Service, Wansbeck General Hospital, Northumbria Healthcare NHS Foundation Trust, Northumberland, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McKevitt', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McMeekin', 'Affiliation': 'Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Stamp', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Stevens', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24240']
2789,32469084,"The impact of high-fidelity simulation on knowledge, critical thinking, and clinical decision-making for the management of pre-eclampsia.","OBJECTIVE


To investigate the impact of high-fidelity simulation on nursing students' knowledge, critical thinking, and clinical decision-making in the management of pre-eclampsia, and to explore the students' views and learning experiences.
METHODS


A mixed-methods design study was conducted on 107 third-year nursing students. The students were randomly assigned to the control group (n=54) or the experimental group (n=53). The students in the experimental group attended the simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia.""
RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation. In the focus group interviews, five themes were identified: learning development; closing the gap between theory and practice; confident decision-making and self-confidence; professional preparation; and recommendations.
CONCLUSION


High-fidelity simulation is efficacious for improving the management of pre-eclampsia among nursing students.",2020,"RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.",['107 third-year nursing students'],"['simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia', 'High-fidelity simulation']",[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]",[],5.0,0.0259582,"RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.","[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Akalin', 'Affiliation': 'Nursing Department, Duzce University, Faculty of Health Sciences, Duzce, Turkey.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Sahin', 'Affiliation': 'Nursing Department, Ankara Yildirim Beyazit University, Faculty of Health Sciences, Ankara, Turkey.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13243']
2790,32469106,Addressing social stressors in a brief motivational interview improve mental health symptoms for Latinx heavy drinkers.,"OBJECTIVE


Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs. This secondary analysis of a clinical trial to reduce hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI]) examined effects on anxiety/depressive symptoms. Discrimination and acculturation were examined as moderators.
METHODS


Latinx (n = 296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males) were randomized to CAMI/MI. Generalized estimating equations analyzed how treatment conditions and interactions were related to depressive and anxiety symptoms after controlling for covariates.
RESULTS


Baseline symptoms (anxiety, depression) exceeded clinical thresholds (Anxiety ≥8, M = 14.62, SD = 13.52; Depression ≥ 12, M = 18.78, SD = 12.57). Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI. CAMI with high baseline discrimination reported significantly less depression than MI (12 months).
CONCLUSIONS


Explicitly addressing social stressors may be a beneficial adjunct to treatment for Latinx drinkers.",2020,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","['Latinx heavy drinkers', 'Latinx drinkers', 'Latinx (n\u2009', '296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males', 'Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs']","['Cultural adaptation of motivational interviewing (CAMI', 'hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI', 'CAMI/MI']","['anxiety and depressive symptoms', 'depressive and anxiety symptoms', 'anxiety/depressive symptoms', 'mental health symptoms', 'Baseline symptoms (anxiety, depression) exceeded clinical thresholds ']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0149421,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Practice, Boston University School of Social Work, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosales', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Koriann', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Department of Applied Psychology, Northeastern University, Boston, Massachusetts.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}]",Journal of clinical psychology,['10.1002/jclp.22976']
2791,32469184,"Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer.","BACKGROUND


Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.
METHODS


In this double-blind, phase 3 trial, men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy were randomly assigned (in a 2:1 ratio) to receive enzalutamide at a dose of 160 mg or placebo once daily. Overall survival was assessed with a group sequential testing procedure and an O'Brien-Fleming-type alpha-spending function.
RESULTS


As of October 15, 2019, a total of 288 of 933 patients (31%) in the enzalutamide group and 178 of 468 (38%) in the placebo group had died. Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001). The exposure-adjusted rate of adverse events of grade 3 or higher was 17 per 100 patient-years in the enzalutamide group and 20 per 100 patient-years in the placebo group. Adverse events in the enzalutamide group were consistent with those previously reported for enzalutamide; the most frequently reported events were fatigue and musculoskeletal events.
CONCLUSIONS


Enzalutamide plus androgen-deprivation therapy resulted in longer median overall survival than placebo plus androgen-deprivation therapy among men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level. The risk of death associated with enzalutamide was 27% lower than with placebo. Adverse events were consistent with the established safety profile of enzalutamide. (Funded by Pfizer and Astellas Pharma; PROSPER ClinicalTrials.gov number, NCT02003924.).",2020,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","['men who had nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy']","['Enzalutamide plus androgen-deprivation therapy', 'placebo plus androgen-deprivation therapy', 'enzalutamide', 'enzalutamide at a dose of 160 mg or placebo', 'placebo']","['Median overall survival', 'risk of death', 'Adverse events', 'Overall survival', 'died', 'median overall survival', 'metastasis-free survival', 'Enzalutamide and Survival', 'fatigue and musculoskeletal events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.755206,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ubirajara', 'Initials': 'U', 'LastName': 'Ferreira', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Madziarska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kolinsky', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Daniel I G', 'Initials': 'DIG', 'LastName': 'Cubero', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Noerby', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Zohren', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2003892']
2792,32469260,"Beetroot ( Beta Vulgaris L. ) Extract Acutely Improves Heart Rate Variability Recovery Following Strength Exercise: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial-Pilot Study.","Objective:  We assessed the acute effect of beetroot extract intake on cardiovascular and autonomic recovery subsequent to strength exercise. Methods:  This is a crossover, randomized, double-blind and placebo-controlled trial. We assessed 16 subjects but only 12 healthy male adults completed the two protocols in two randomized days: Beetroot extract (600 mg in capsule) and placebo (600 mg starch in capsule). Beetroot extract or placebo was ingested, the subjects endured 120 minutes seated at rest, followed by a 75% 1RM strength exercise and then remained seated for 60 minutes at rest. Cardiorespiratory parameters, heart rate (HR) variability (HRV) (SDNN, rMSSD, pNN50, SD1, SD2 HF [ms 2 ]) were estimated before, during exercise and during recovery from exercise. Results:  ingestion of beetroot extract before exercise: accelerates the recovery of SBP following physical effort; improves HR recovery to baseline resting levels (beetroot protocol: change in ∼62% vs. placebo protocol: change in ∼80%), and intensifies the return of vagal HR control during recovery after exercise. Conclusions:  Beetroot extract acutely improved cardiovascular and autonomic recovery after exercise.",2020,"Results:  ingestion of beetroot extract before exercise: accelerates the recovery of SBP following physical effort; improves HR recovery to baseline resting levels (beetroot protocol: change in ∼62% vs. placebo protocol: change in ∼80%), and intensifies the return of vagal HR control during recovery after exercise.",['16 subjects but only 12 healthy male adults'],"['Strength Exercise', 'Placebo', 'placebo', 'Beetroot ( Beta Vulgaris L. ', 'Beetroot extract (600\u2009mg in capsule) and placebo', 'beetroot extract intake', 'Beetroot extract', 'Beetroot extract or placebo', 'Extract']","['Cardiorespiratory parameters, heart rate (HR) variability (HRV) (SDNN, rMSSD, pNN50, SD1, SD2 HF', 'Heart Rate Variability Recovery', 'cardiovascular and autonomic recovery']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",,0.629267,"Results:  ingestion of beetroot extract before exercise: accelerates the recovery of SBP following physical effort; improves HR recovery to baseline resting levels (beetroot protocol: change in ∼62% vs. placebo protocol: change in ∼80%), and intensifies the return of vagal HR control during recovery after exercise.","[{'ForeName': 'Cicero Jonas R', 'Initials': 'CJR', 'LastName': 'Benjamim', 'Affiliation': 'Development, Nutrition, Phytotherapy and Hygiene Research Group, University of Pernambuco, Petrolina, PE, Brazil.'}, {'ForeName': 'Francisco Wellington', 'Initials': 'FW', 'LastName': 'S Júnior', 'Affiliation': 'Physiological and Collective Sciences Nucleus, University Center of Juazeiro do Norte, Juazeiro do Norte, CE, Brazil.'}, {'ForeName': 'Maria Íris L S', 'Initials': 'MÍLS', 'LastName': 'de Figueirêdo', 'Affiliation': 'Physiological and Collective Sciences Nucleus, University Center of Juazeiro do Norte, Juazeiro do Norte, CE, Brazil.'}, {'ForeName': 'Cicera Josilânia R', 'Initials': 'CJR', 'LastName': 'Benjamim', 'Affiliation': 'Physiological and Collective Sciences Nucleus, University Center of Juazeiro do Norte, Juazeiro do Norte, CE, Brazil.'}, {'ForeName': 'Taisy C Ferro', 'Initials': 'TCF', 'LastName': 'Cavalcante', 'Affiliation': 'Development, Nutrition, Phytotherapy and Hygiene Research Group, University of Pernambuco, Petrolina, PE, Brazil.'}, {'ForeName': 'Amanda A Marcelino', 'Initials': 'AAM', 'LastName': 'da Silva', 'Affiliation': 'Development, Nutrition, Phytotherapy and Hygiene Research Group, University of Pernambuco, Petrolina, PE, Brazil.'}, {'ForeName': 'Larissa Raylane L', 'Initials': 'LRL', 'LastName': 'Monteiro', 'Affiliation': 'Physiological and Collective Sciences Nucleus, University Center of Juazeiro do Norte, Juazeiro do Norte, CE, Brazil.'}, {'ForeName': 'Milana Drumond R', 'Initials': 'MDR', 'LastName': 'Santana', 'Affiliation': 'Physiological and Collective Sciences Nucleus, University Center of Juazeiro do Norte, Juazeiro do Norte, CE, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Health and Life Sciences, Cardiorespiratory Research Group, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University, UNESP, Marilia, SP, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1774441']
2793,32469304,Pharmacodynamic evaluation of L-carnitine and piracetam in muscle injury induced by the chronic use of simvastatin
.,"OBJECTIVES


To evaluate the effect of L-carnitine and piracetam on the muscle injury induced by simvastatin in healthy male subjects during the therapy with oral doses of 10 mL of a solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin once a day during 35 consecutive days. The effect of L-carnitine and piracetam in the reduction of myopathic symptomatology caused by exercise, as well as safety and tolerability were also evaluated.
MATERIALS AND METHODS


This study was performed on two different occasions, of which 42 subjects were investigated on occasion 1 and 19 on occasion 2. Discomfort or pain was evaluated according to modified Borg scale. Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH) were evaluated on the 4th, 11th, 18th, 25th, and 32nd day after therapy, and before and until 4 hours after an exercise test performed on a treadmill on day 36.
RESULTS


A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295). The serum levels of AST, ALT, and LDH were statistically different, with lower values in the test group compared to the control group.
CONCLUSION


Concomitant use of L-carnitine and piracetam might have a muscle-protective effect and protection against simvastatin-induced myalgia. Furthermore, the formulation was safe and well tolerated by the subjects investigated in this trial.
.",2020,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","['42 subjects were investigated on occasion 1 and 19 on occasion 2', 'healthy male subjects during the therapy with oral doses of 10 mL of a']","['L-carnitine and piracetam', 'simvastatin', 'solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin']","['Discomfort or pain', 'safety and tolerability', 'serum levels of AST, ALT, and LDH', 'safe and well tolerated', 'pain or discomfort', 'Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH']","[{'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0031977', 'cui_str': 'Piracetam'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",42.0,0.0436808,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","[{'ForeName': 'Renan Marcel Bonilha', 'Initials': 'RMB', 'LastName': 'Dezena', 'Affiliation': ''}, {'ForeName': 'Natalícia de Jesus', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ilha', 'Affiliation': ''}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': ''}, {'ForeName': 'Paulo César Pires', 'Initials': 'PCP', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203496']
2794,32469305,Bioavailability study of two 81-mg coated tablet formulations of acetylsalicylic acid in fed healthy subjects
.,"OBJECTIVE


To perform a comparative bioavailability study between a test (re-formulation) and a reference acetylsalicylic acid formulation (Ecasil-81, 81 mg coated tablet) in healthy subjects under fed condition.
MATERIALS AND METHODS


Healthy subjects (n = 48) were included in this monocentric, open-label, randomized, two-way crossover pharmacokinetic study. They received a single 81-mg oral dose of a test or a reference formulation of acetylsalicylic acid under fed condition, with a 7-day washout period between the treatments. Blood samples were collected over a period of 36 hours. The salicylic acid plasma concentration was measured by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). Pharmacokinetic analysis was performed using WinNonlin software.
RESULTS


The geometric mean and 90% confidence interval of test/reference formulation ratios were 109.32% (102.54 - 116.54%) and 106.94% (102.97 - 111.07%) for salicylic acid C max  and AUC 0-last , respectively. Food decreased the AUC and C max  (p < 0.001) and delayed the t max  (p = 0.0077). The investigated women presented higher AUC 0-∞  and C max  values (p < 0.001) than men. The clinical and laboratory exams did not show significant alterations.
CONCLUSION


The re-formulation is bioequivalent to the reference formulation regarding the absorption extent and rate in fed healthy subjects. The administration of acetylsalicylic acid with food decreased its bioavailability. Moreover, differences in salicylic acid disposition related to sex were observed. The treatments were well tolerated by the investigated subjects.
.",2020,The investigated women presented higher AUC 0-∞  and C max  values (p < 0.001) than men.,"['healthy subjects under fed condition', 'fed\xa0healthy subjects\u2029', 'fed healthy subjects', 'Healthy subjects (n\xa0=\xa048']","['acetylsalicylic acid', 'acetylsalicylic acid formulation (Ecasil-81, 81\xa0mg coated tablet']","['salicylic acid disposition', 'Blood samples', 'bioavailability', 'geometric mean and 90% confidence interval of test/reference formulation ratios', 'salicylic acid plasma concentration', 'AUC and C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.0240262,The investigated women presented higher AUC 0-∞  and C max  values (p < 0.001) than men.,"[{'ForeName': 'Raul Cleverson', 'Initials': 'RC', 'LastName': 'Dolores', 'Affiliation': ''}, {'ForeName': 'Natalícia de Jesus', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': ''}, {'ForeName': 'Alexandre Scremin', 'Initials': 'AS', 'LastName': 'Czezacki', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Previato', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': ''}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203575']
2795,32471908,Effects of Sustained Treatment With Lixisenatide on Gastric Emptying and Postprandial Glucose Metabolism in Type 2 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


Tachyphylaxis for slowing of gastric emptying is seen with continuous exposure to glucagon-like peptide 1 (GLP-1). We therefore aimed to establish whether prolonged use of a ""short-acting"" GLP-1 receptor agonist, lixisenatide, achieves sustained slowing of gastric emptying and reduction in postprandial glycemia.
RESEARCH DESIGN AND METHODS


A total of 30 patients with metformin-treated type 2 diabetes underwent assessment of gastric emptying (scintigraphy) and glucose metabolism (dual tracer technique) after a 75-g glucose drink, before and after 8 weeks' treatment with lixisenatide (20 μg subcutaneously daily) or placebo, in a double-blind randomized parallel design.
RESULTS


Gastric retention of the glucose drink was markedly increased after lixisenatide versus placebo (ratio of adjusted geometric means for area under curve [AUC] over 240 min of 2.19 [95% CI 1.82, 2.64;  P  < 0.001]), associated with substantial reductions in the rate of systemic appearance of oral glucose ( P  < 0.001) and incremental AUC for blood glucose ( P  < 0.001). Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake. Postprandial glucose lowering over 240 min was strongly related to the magnitude of slowing of gastric emptying by lixisenatide ( r  = -0.74,  P  = 0.002) and to the baseline rate of emptying ( r  = 0.52,  P  = 0.048) but unrelated to β-cell function (assessed by β-cell glucose sensitivity).
CONCLUSIONS


Eight weeks' treatment with lixisenatide is associated with sustained slowing of gastric emptying and marked reductions in postprandial glycemia and appearance of ingested glucose. Short-acting GLP-1 receptor agonists therefore potentially represent an effective long-term therapy for specifically targeting postprandial glucose excursions.",2020,"Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake.","['Type 2 Diabetes', '30 patients with']","['lixisenatide', 'Lixisenatide', 'metformin-treated type 2 diabetes underwent assessment of gastric emptying (scintigraphy) and glucose metabolism (dual tracer technique', 'placebo']","['Gastric Emptying and Postprandial Glucose Metabolism', 'Postprandial glucose lowering', 'rate of systemic appearance of oral glucose', 'Gastric retention of the glucose drink', 'incremental AUC for blood glucose', 'baseline rate of emptying', 'gastric emptying', 'postprandial glycemia and appearance of ingested glucose']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585136', 'cui_str': 'Gastric retention'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.156761,"Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake.","[{'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia chris.rayner@adelaide.edu.au.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Watson', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Bound', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Grivell', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tricò', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Frascerra', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natali', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}]",Diabetes care,['10.2337/dc20-0190']
2796,32471910,Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.
RESEARCH DESIGN AND METHODS


After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol]) were randomly assigned to CLC ( N  = 54, Control-IQ) or PLGS ( N  = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.
RESULTS


All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC versus 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI: 3.6, 8.3%;  P  < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI: -8.4, -3.7%;  P  < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI: -0.05, 0.13%;  P  = 0.41). HbA 1c  after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] versus 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI: -0.57 [-6.2 mmol/mol], -0.11% [1.2 mmol/mol];  P  = 0.0035).
CONCLUSIONS


Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA 1c  toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.",2020,HbA 1c  after 13 weeks was lower on CLC than PLGS (,"['Type 1 Diabetes', 'All 109 participants completed the study', '109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol']","['CLC', 'CLC Versus PLGS', 'closed-loop control (CLC) system', 'CLC system', 'PLGS']","['continuous glucose monitor (CGM)-measured time in range (TIR', 'Mean ± SD TIR', 'TIR and increased HbA 1c  toward their pre-CLC values, while hypoglycemia']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",109.0,0.176696,HbA 1c  after 13 weeks was lower on CLC than PLGS (,"[{'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ambler-Osborn', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Levister', 'Affiliation': ''}, {'ForeName': 'Vinaya', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': ''}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': ''}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0124']
2797,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st  day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8']
2798,32472001,Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis.,"The OlympiAD Phase III study (NCT02000622) established the clinical benefits of olaparib tablet monotherapy (300 mg twice daily) over chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting. Here, we report pre-specified analyses of data from Asian (China, Japan, Korea and Taiwan) patients in the study. All patients were randomized 2:1 to olaparib tablets (300 mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine). The primary endpoint was progression-free survival assessed by blinded independent central review. The prevalence of gBRCAm in the OlympiAD Asian subgroup screened for study recruitment was 13.5%. Patient demographics and disease characteristics of the Asian subgroup (87/302 patients) were generally well balanced between treatment arms. Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population. Findings on secondary efficacy and safety/tolerability outcome measures in Asian patients were also similar to those observed in the global OlympiAD study population. The OlympiAD study was not powered to detect race-related differences between treatment groups; however, the consistency of our findings with the global OlympiAD study population suggests that previously reported findings are generalizable to Asian patients.",2020,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","['Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer', 'patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting', 'Asian (China, Japan, Korea and Taiwan) patients in the study', 'Asian patients']","['olaparib tablet monotherapy', ""chemotherapy treatment of physician's choice (TPC"", 'olaparib tablets (300\u2009mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine', 'Olaparib monotherapy']","['secondary efficacy and safety/tolerability outcome measures', 'progression-free survival', 'longer median progression-free survival']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.177673,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","[{'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea. moisa@snu.ac.kr.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Medical Oncology Center, Hunan Tumor Hospital, Changsha, China.'}, {'ForeName': 'Dah-Cherng', 'Initials': 'DC', 'LastName': 'Yeh', 'Affiliation': 'Cheng Ching Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyuk', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-63033-4']
2799,32472012,The effectiveness of quick starting oral contraception containing nomegestrol acetate and 17-β estradiol on ovulation inhibition: A randomized controlled trial.,"To determine the effectiveness of quick starting combined oral contraception (COC) contain 2.5 mg nomegestrol acetate and 1.5 mg estradiol (NOMAC/E2) comparing with 0.075 mg gestodene and 0.02 mg ethinyl estradiol (GS/EE) on ovarian ovulation inhibition rate, we conducted a non-inferiority randomized controlled trial involving 69 healthy female volunteers aged 18-40 years who had normal menstrual history and were randomized at a 2:1 ratio to take one pack of COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9. The ovarian activity was assessed by using Hoogland and Skouby grading. Forty-six and 23 participants were randomized to NOMAC/E2 and GS/EE groups, respectively. Baseline characteristics were similar between groups. No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000). Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.",2020,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","['69 healthy female volunteers aged 18-40 years who had normal menstrual history', 'Forty-six and 23 participants']","['nomegestrol acetate and 17-β estradiol', 'NOMAC/E2 and GS/EE', 'gestodene and 0.02\u2009mg ethinyl estradiol (GS/EE', 'quick starting combined oral contraception (COC) contain 2.5\u2009mg nomegestrol acetate and 1.5\u2009mg estradiol (NOMAC/E2', 'COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9']","['ovarian ovulation inhibition rate', 'ovulation rate', 'ovarian quiescence rate', 'ovulation inhibition rate', 'persistent cyst rate', 'ovulation inhibition', 'ovarian activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0132749', 'cui_str': 'Nomegestrol acetate'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0061246', 'cui_str': 'Gestodene'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0029968', 'cui_str': 'Ovulation Suppression'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",69.0,0.249135,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","[{'ForeName': 'Preeyaporn', 'Initials': 'P', 'LastName': 'Jirakittidul', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. preeyajira@hotmail.com.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Angsuwathana', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manee', 'Initials': 'M', 'LastName': 'Rattanachaiyanont', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thunyada', 'Initials': 'T', 'LastName': 'Thiampong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanon', 'Initials': 'C', 'LastName': 'Neungton', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaphorn', 'Initials': 'B', 'LastName': 'Chotrungrote', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Scientific reports,['10.1038/s41598-020-65642-5']
2800,32472048,Efficacy of conbercept combined with panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.,"This prospective clinical study was to compare the effect of panretinal photocoagulation (PRP) associated with intravitreal conbercept injections versus PRP alone in the treatment of proliferative diabetic retinopathy (PDR). For each of 15 patients included, one eye was randomly assigned to receive treatment with PRP, and the other eye received conbercept combined PRP. Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) were performed at baseline and at each monthly visit until 6 months. Fluorescein angiography (FA) was acquired at baseline, 3 months and 6 months. Between group and within group analysis was done by using generalized estimating equations (GEE). The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months. Within-group analysis indicated a significant decrease in NV leakage at month 3 and month 6 in both groups, and a significant increase in BCVA at 1 month in the combination group. In summary, the combination of intravitreal injection of conbercept and PRP can significantly reduce the NV of PDR patients and achieve better BCVA during the drug's lifespan compared with PRP alone.",2020,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","['proliferative diabetic retinopathy', '15 patients included, one eye', 'proliferative diabetic retinopathy (PDR']","['PRP', 'conbercept combined with panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Fluorescein angiography (FA', 'intravitreal conbercept injections versus PRP alone', 'Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA', 'conbercept combined PRP']","['NV leakage', 'better best-corrected visual acuity (BCVA', 'BCVA', 'neovascularization (NV) leakage area']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0268657,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Statistics, School of Economics, Shanghai University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. yuweihongeye@foxmail.com.'}]",Scientific reports,['10.1038/s41598-020-65833-0']
2801,32472075,Two nights of recovery sleep restores hippocampal connectivity but not episodic memory after total sleep deprivation.,"Sleep deprivation significantly impairs a range of cognitive and brain function, particularly episodic memory and the underlying hippocampal function. However, it remains controversial whether one or two nights of recovery sleep following sleep deprivation fully restores brain and cognitive function. In this study, we used functional magnetic resonance imaging (fMRI) and examined the effects of two consecutive nights (20-hour time-in-bed) of recovery sleep on resting-state hippocampal connectivity and episodic memory deficits following one night of total sleep deprivation (TSD) in 39 healthy adults in a controlled in-laboratory protocol. TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity. Following TSD, two nights of recovery sleep restored hippocampal connectivity to baseline levels, but did not fully restore memory performance nor its associations with hippocampal connectivity. These findings suggest that more than two nights of recovery sleep are needed to fully restore memory function and hippocampal-memory associations after one night of total sleep loss.",2020,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.",['39 healthy adults in a controlled in-laboratory protocol'],"['two consecutive nights (20-hour time-in-bed) of recovery sleep', 'total sleep deprivation (TSD', 'TSD', 'functional magnetic resonance imaging (fMRI']","['hippocampal connectivity to multiple prefrontal and default mode network regions', 'Sleep deprivation', 'memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",39.0,0.0326211,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Fan Nils', 'Initials': 'FN', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Sihua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Junghoon J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular, Cellular, and Biomedical Sciences, CUNY School of Medicine, The City College of New York, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. hengyi@pennmedicine.upenn.edu.'}]",Scientific reports,['10.1038/s41598-020-65086-x']
2802,32472141,"A Prospective Cohort Study to Evaluate the Impact of Diet, Exercise, and Lifestyle on Fertility (IDEAL): Design and Baseline Characteristics.","Diet, lifestyle, and psychosocial factors may influence fertility for men and women, though evidence is mixed, and couple-based approaches are needed for assessing associations with reproductive outcomes. The Impact of Diet, Exercise, and Lifestyle on Fertility (IDEAL) study is a prospective cohort with contemporaneous detailed follow-up of female partners of men enrolled in the Folic Acid and Zinc Supplementation Trial studying couples seeking infertility treatment (2016-2019). Follow-up of men continued for 6 months, while female partners were followed for 9 months while attempting pregnancy and throughout any resulting pregnancy (up to 18 months). Longitudinal data on diet, physical activity (including measurement via Fitbit), sleep, and stress were captured at multiple study visits during this follow-up. A subset of women (IDEALplus) also completed daily journals and a body fat assessment via dual X-ray absorptiometry. 920 women were enrolled in IDEAL and 218 in IDEALPlus. We demonstrated the ability to enroll women in a prospective cohort study contemporaneous to a partner-enrolled randomized trial. In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes. We describe in detail the study design, recruitment, data collection, lessons learned, and baseline characteristics.",2020,"In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes.","['female partners of men enrolled in the', 'male partners', 'men and women', '920 women were enrolled in IDEAL and 218 in IDEALPlus', 'Trial studying couples seeking infertility treatment (2016-2019']","['Diet, Exercise, and Lifestyle on Fertility', 'Diet, Exercise, and Lifestyle', 'Folic Acid and Zinc Supplementation']","['diet, physical activity (including measurement via Fitbit), sleep, and stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",920.0,0.0272319,"In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes.","[{'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Mudsar', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Salmon', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'The Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Hotaling', 'Affiliation': ""Department of Surgery (Urology), Center for Reconstructive Urology and Men's Health, University of Utah School of Medicine, Salt Lake City, Utah.""}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company LLC, Rockville, Maryland.'}]",American journal of epidemiology,['10.1093/aje/kwaa073']
2803,32472357,Bioequivalence and Tolerability of Ambrisentan: A Pharmacokinetic Study in Mexican Healthy Male Subjects.,"BACKGROUND


Pulmonary arterial hypertension (PAH) is a disease characterized by a progressive rise in pulmonary vascular resistance. Ambrisentan is an oral, propanoic acid based-endothelin receptor antagonist (ERA), selective for the endothelin type-A receptor, which is approved for the treatment of PAH. The Colombia National Food and Drug Surveillance Institute regulatory criteria require demonstrating that the proposed generic product is bioequivalent to its reference-listed drug to obtain marketing approval.
OBJECTIVES


The purpose of this study was to test the bioequivalence, pharmacokinetics, and tolerability of ambrisentan 10 mg tablets.
METHODS


In this open-label, randomized, oral single-dose, two-way crossover bioequivalence study, 26 Mexican adult healthy male subjects received either the generic product of ambrisentan 10 mg or the reference product Volibris ®  (ambrisentan) 10 mg tablets during each study period under fasting conditions. There was a 7-day washout period between each dosing. Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method. Blood samples were collected up to 72 h post-dose in each study period. The primary end points were maximum plasma concentration (C max ) and area under the plasma concentration-time (AUC 0-t ) curve between 0 and 72 h for ambrisentan.
RESULTS


The ratios (90% CI) of geometric mean for ambrisentan were 104.3% (97.12-111.98%) and 100.2% (95.56-104.72%). These pharmacokinetic parameter values lie within the INVIMA-specified bioequivalence limits of 80%-125%. Nervous system disorders were the most common adverse events (AEs). All AEs were mild to moderate in nature and were resolved after follow-up or pharmacologic treatment. Both products were safe and well tolerated.
CONCLUSIONS


The test product ambrisentan 10 mg tablets is bioequivalent to the reference product Volibris ®  (ambrisentan) 10 mg tablets. Both treatments were well tolerated in the Mexican male population of this study.
TRIAL REGISTRATION


COFEPRIS National Clinical Trials Registry number 183300410B0367/2018.",2020,Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method.,"['Mexican male population of this study', 'Mexican Healthy Male Subjects', '26 Mexican adult healthy male subjects']","['Ambrisentan', 'ambrisentan 10\xa0mg tablets', 'generic product of ambrisentan 10\xa0mg or the reference product Volibris ®  (ambrisentan) 10\xa0mg tablets']","['maximum plasma concentration (C max ) and area under the plasma concentration-time (AUC 0-t ) curve', 'bioequivalence, pharmacokinetics, and tolerability', 'geometric mean for ambrisentan', 'safe and well tolerated']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1949320', 'cui_str': 'ambrisentan 10 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}]",26.0,0.0673094,Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method.,"[{'ForeName': 'Karen Paola Camarillo', 'Initials': 'KPC', 'LastName': 'Cárdenas', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México. kcamarilloc@avantsante.com.'}, {'ForeName': 'Joceline Estefanía Rangel', 'Initials': 'JER', 'LastName': 'Velázquez', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}, {'ForeName': 'Javier Jesús Osorio', 'Initials': 'JJO', 'LastName': 'Escobar', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chirinos', 'Affiliation': 'Abbott Laboratories de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Pendela', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00627-3']
2804,32472363,Role of Aspirin for Primary Prevention in Persons with Diabetes Mellitus and in the Elderly.,"PURPOSE OF REVIEW


To review the clinical evidence of the effect of aspirin as primary prevention for patients with diabetes mellitus and in healthy elderly.
RECENT FINDINGS


Two trials were performed to study these two patient populations: ASCEND showed that the use of low-dose aspirin in persons with diabetes, who did not have prior cardiovascular disease, led to a lower risk of cardiovascular events than placebo (8.5% vs 9.6%, rate ratio 0.88, 95% CI 0.79-0.97; p = 0.01). However, it showed a similar magnitude of increased risk of major bleeding among the aspirin group compared with placebo (4.1% vs 3.2%, rate ratio 1.29, 95% CI 1.09-1.52; p = 0.003). ASPREE showed that the use of low-dose aspirin in healthy elderly did not prolong disability-free survival (21.5% vs 21.2%, HR 1.01, 95% CI 0.92-1.11; p = 0.79); however, the rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs 2.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). Additionally, further analyses of secondary end points of death, cardiovascular disease, and major hemorrhage were also studied. Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths. Similar risk of cardiovascular disease was seen among elderly who received aspirin compared with placebo (10.7% vs 11.3%, HR 0.95, 95% CI 0.83-1.08) and resulted in a significantly higher risk of major hemorrhage (8.6% vs 6.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). These studies show that the use of low-dose aspirin as primary prevention in patients with diabetes and in the elderly does not have overall beneficial effect compared with its use in secondary prevention. In patients with diabetes without prior cardiovascular disease, the benefits of aspirin use were counterbalanced by the bleeding risk. Additionally, in healthy elderly, the use of aspirin did not prolong disability-free survival and instead led to a higher rate of major hemorrhage.",2020,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","['patients with diabetes mellitus and in healthy elderly', 'Persons with Diabetes Mellitus and in the Elderly', 'patients with diabetes', 'patients with diabetes without prior cardiovascular disease']","['placebo', 'Aspirin', 'aspirin']","['death, cardiovascular disease, and major hemorrhage', 'risk of major bleeding', 'risk of major hemorrhage', 'rate of major hemorrhage', 'disability-free survival', 'Similar risk of cardiovascular disease', 'cause mortality', 'risk of cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.173039,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","[{'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Patel', 'Affiliation': 'University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Ragavendra R', 'Initials': 'RR', 'LastName': 'Baliga', 'Affiliation': 'The Ohio State University Medical Center, Columbus, OH, USA. rrbaliga@gmail.com.'}]",Current cardiology reports,['10.1007/s11886-020-01296-z']
2805,32472567,Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers.,"BACKGROUND


The Otago Exercise Program (OEP) has demonstrated cost-effectiveness for the primary prevention of falls in a general community setting. The cost-effectiveness of exercise as a secondary falls prevention (ie, preventing falls among those who have already fallen) strategy remains unknown. The primary objective was to estimate the cost-effectiveness (incremental cost-effectiveness/utility ratio) of the OEP from a healthcare system perspective.
DESIGN


A concurrent 12-month prospective economic evaluation conducted alongside the Action Seniors! randomized critical trial (OEP compared with usual care).
SETTING


Vancouver Falls Prevention Clinic (Vancouver, BC, Canada; http://www.fallsclinic.ca).
PARTICIPANTS


A total of 344 community-dwelling older adults, aged 70 years and older, who attended a geriatrician-led Falls Prevention Clinic in Vancouver, after sustaining a fall in the previous 12 months.
MEASUREMENTS


Main outcome measures included: incidence rate ratio for falls, healthcare costs, incremental cost per fall prevented, and incremental cost per quality-adjusted life year (QALY) gained.
RESULTS


The OEP costs $393 CAD per participant to implement. The incremental cost per fall prevented resulted in a savings of $2 CAD. The incremental cost per QALY gained (where QALYs were estimated using the Euro-Qol 5D three-level version [EQ-5D-3L]) indicated the OEP was less effective than usual care. The incremental cost per QALY gained (where QALYs were estimated using the Short Form 6D [SF-6D]) indicated the OEP was more effective and less costly than usual care. The incremental QALYs estimated using the EQ-5D-3L and the SF-6D were not clinically significant and close to zero, indicating no change in quality of life.
CONCLUSION


Compared with usual care, healthcare system costs are saved and falls are prevented when older fallers who attend a geriatrician-led falls clinic are allocated to, and provided, the physiotherapist-guided exercise-based falls prevention program (the OEP).",2020,"Compared with usual care, healthcare system costs are saved and falls are prevented when older fallers who attend a geriatrician-led falls clinic are allocated to, and provided, the physiotherapist-guided exercise-based falls prevention program (the OEP).","['Community-Dwelling Older Fallers', 'A total of 344 community-dwelling older adults, aged 70\u2009years and older, who attended a geriatrician-led Falls Prevention Clinic in Vancouver, after sustaining a fall in the previous 12\u2009months', 'Vancouver Falls Prevention Clinic (Vancouver, BC, Canada', 'older fallers who attend a geriatrician-led falls clinic']","['Otago Exercise Program (OEP', 'Secondary Falls Prevention Strategy', 'OEP']","['incidence rate ratio for falls, healthcare costs, incremental cost per fall prevented, and incremental cost per quality-adjusted life year (QALY) gained', 'quality of life', 'cost-effectiveness (incremental cost-effectiveness/utility ratio', 'OEP costs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",344.0,0.0571141,"Compared with usual care, healthcare system costs are saved and falls are prevented when older fallers who attend a geriatrician-led falls clinic are allocated to, and provided, the physiotherapist-guided exercise-based falls prevention program (the OEP).","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Social and Economic Change Laboratory, Faculty of Management, University of British Columbia-Okanagan, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Karim M', 'Initials': 'KM', 'LastName': 'Khan', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Chun Liang', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Cook', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Dian', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16476']
2806,32472611,Novel Dose Escalation to Predict Treatment with Hydroxyurea (NDEPTH): A Randomized Controlled Trial of a Dose-Prediction Equation to Determine Maximum Tolerated Dose of Hydroxyurea in Pediatric Sickle Cell Disease.,,2020,,['Pediatric Sickle Cell Disease'],"['Hydroxyurea (NDEPTH', 'Hydroxyurea']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]",[],,0.125772,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'George', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Dinu', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Estrada', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hurwitz', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Mahoney', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Yates', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Alaundra', 'Initials': 'A', 'LastName': 'Carmouche', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Gladstone', 'Initials': 'G', 'LastName': 'Airewele', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirk', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Titilope', 'Initials': 'T', 'LastName': 'Fasipe', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Uwaezuoke', 'Affiliation': ""Texas Children's Cancer and Hematology Centers, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati.""}]",American journal of hematology,['10.1002/ajh.25883']
2807,32472620,Acute Alcohol Intake Produces Widespread Decreases in Cortical Resting Signal Variability in Healthy Social Drinkers.,"BACKGROUND


Acute alcohol intoxication has wide-ranging neurobehavioral effects on psychomotor, attentional, inhibitory, and memory-related cognitive processes. These effects are mirrored in disruption of neural metabolism, functional activation, and functional network coherence. Metrics of intraregional neural dynamics such as regional signal variability (RSV) and brain entropy (BEN) may capture unique aspects of neural functional capacity in healthy and clinical populations; however, alcohol's influence on these metrics is unclear. The present study aimed to elucidate the influence of acute alcohol intoxication on RSV and to clarify these effects with subsequent BEN analyses.
METHODS


26 healthy adults between 25 and 45 years of age (65.4% women) participated in two counterbalanced sessions. In one, participants consumed a beverage containing alcohol sufficient to produce a breath alcohol concentration of 0.08 g/dL. In the other, they consumed a placebo beverage. Approximately 35 minutes after beverage consumption, participants completed a 9-minute resting state fMRI scan. Whole brain, voxel-wise standard deviation was used to assess RSV, which was compared between sessions. Within clusters displaying alterations in RSV, sample entropy was calculated to assess BEN.
RESULTS


Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule. Within these clusters, significant reductions in BEN were found in the bilateral middle frontal and right superior frontal gyri. No effects were noted in subcortical or cerebellar areas.
CONCLUSIONS


Findings indicate that alcohol intake produces diffuse reductions in RSV among structures associated with attentional processes. Within these structures, signal complexity was also reduced in a subset of frontal regions. Neurobehavioral effects of acute alcohol consumption may be partially driven by disruption of intraregional neural dynamics among regions involved in higher order cognitive and attentional processes.",2020,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","['Healthy Social Drinkers', 'healthy and clinical populations', '26 healthy adults between 25 and 45 years of age (65.4% women']","['placebo beverage', 'placebo, alcohol intake']","['BEN', 'disruption of neural metabolism, functional activation, and functional network coherence', 'subcortical or cerebellar areas', 'bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule']","[{'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}]",26.0,0.111513,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","[{'ForeName': 'Landrew', 'Initials': 'L', 'LastName': 'Sevel', 'Affiliation': 'Osher Center for Integrative Medicine at Vanderbilt, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stennett', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Schneider', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bush', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, FL, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14381']
2808,32472792,Clinical Efficacy of Immediate Manual Meibomian Gland Expression After Thermal Pulsation (LipiFlow) for Obstructive Meibomian Gland Dysfunction: Comparison With Thermal Pulsation.,"PURPOSE


To evaluate the clinical efficacy and safety of immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC) for obstructive meibomian gland dysfunction and to compare the LipiFlow only and MGX after LipiFlow.
METHODS


Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included. Thirty eyes from 15 patients were enrolled in each group. All patients underwent 3 treatments at monthly intervals. All patients were followed up for 6 months after treatment. All patients were examined before and at 3 and 6 months after treatment. Examinations included the Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height.
RESULTS


The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001). In the LipiFlow-only group, the NIBUT and LLT significantly improved at 3 months (P < 0.001 and P = 0.006) but deteriorated at 6 months. In the MGX after LipiFlow group, the NIBUT and LLT improved at 3 months (P < 0.001 and P < 0.001), and this improvement was maintained at 6 months. The improvement of NIBUT at 3 months was greater in the MGX after LipiFlow group (3.24 ± 1.16 to 9.25 ± 1.36 s) than in the LipiFlow-only group (3.78 ± 1.75 to 7.18 ± 2.70 s), and the improvements of the LLT at 6 months were greater in the MGX after LipiFlow group (30.27 ± 10.74 to 46.93 ± 20.81 μm) than in the LipiFlow-only group (34.70 ± 10.79 to 38.73 ± 14.70 μm).
CONCLUSIONS


Both LipiFlow only and MGX after LipiFlow were clinically effective for obstructive meibomian gland dysfunction. However, the efficacy and persistence of treatment were greater in patients who received MGX after LipiFlow.",2020,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"['Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included', 'Thirty eyes from 15 patients were enrolled in each group', 'Obstructive Meibomian Gland Dysfunction']","['Immediate Manual Meibomian Gland Expression', 'Thermal Pulsation (LipiFlow', 'immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC']","['Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height', 'Ocular Surface Disease Index scores', 'NIBUT and LLT', 'improvement of NIBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}]",30.0,0.0233914,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"[{'ForeName': 'Hye Jee', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Miso Eye Clinic, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Miso Eye Clinic, Gyeonggi-do, Republic of Korea.'}]",Cornea,['10.1097/ICO.0000000000002328']
2809,32472801,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial: Erratum.,,2020,,['Post-Dural Puncture Headache'],['Prophylactic Intrathecal Morphine'],[],"[{'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.674421,,[],Anesthesiology,['10.1097/ALN.0000000000003411']
2810,32472804,Goal-directed versus Standard Fluid Therapy to Decrease Ileus after Open Radical Cystectomy: A Prospective Randomized Controlled Trial.,"BACKGROUND


Postoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.
METHODS


This is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.
RESULTS


Between August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
CONCLUSIONS


Goal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy. : WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Postoperative ileus is a common complication after intraabdominal surgeriesPrevious studies have found mixed evidence for benefit in goal-[LINE SEPARATOR]directed intraoperative fluid therapy over standard fluid therapy WHAT THIS ARTICLE TELLS US THAT IS NEW: In a randomized trial of goal-directed versus standard fluid therapy in patients having radical cystectomy, there was no difference in the primary outcome of postoperative ileusThere was no difference between fluid therapies in the secondary outcome of high-grade complications.",2020,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","['patients undergoing open radical cystectomy', '283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy', 'patients having radical cystectomy', 'patients receiving radical cystectomy', 'Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation', 'Between August 2014 and April 2018']","['fluid therapy versus standard fluid therapy', 'intraoperative fluid therapy over standard fluid therapy', 'Standard Fluid Therapy', 'Open Radical Cystectomy', 'goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring']","['incidence of high-grade complications', 'postoperative ileus', 'Postoperative ileus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]",,0.569234,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Anesthesiology Service, Memorial Sloan Kettering Cancer Center, New York, New York (V.A.-C., A.C.P., M.F.) the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (K.S.T.) the Department of Surgery, Urology Service, Weill Cornell Medical College, New York, New York. (G.D., H.W.H., B.H.B., E.K.C., T.F.D., S.M.D.) the Department of Urology, Weill Cornell Medical College, New York, New York. (G.D., H.W.H., B.H.B., E.K.C., S.M.D.) Departments of Anesthesiology, Weill Cornell Medical College, New York, New York. (A.C.P., M.F.).'}, {'ForeName': 'Kay See', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': ''}, {'ForeName': 'Alessia C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': ''}, {'ForeName': 'Harry W', 'Initials': 'HW', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Bernard H', 'Initials': 'BH', 'LastName': 'Bochner', 'Affiliation': ''}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'S Machele', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003367']
2811,32472836,"Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury.","OBJECTIVE


Identify the treatment effects of 6 weeks of daily 30-minute sessions of morning blue light therapy compared with placebo amber light therapy in the treatment of sleep disruption following mild traumatic brain injury.
DESIGN


Placebo-controlled randomized trial.
PARTICIPANTS


Adults aged 18 to 45 years with a mild traumatic brain injury within the past 18 months (n = 35).
MAIN OUTCOME MEASURES


Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Beck Depression Inventory II, Rivermead Post-concussion Symptom Questionnaire, Functional Outcomes of Sleep Questionnaire, and actigraphy-derived sleep measures.
RESULTS


Following treatment, moderate to large improvements were observed with individuals in the blue light therapy group reporting lower Epworth Sleepiness Scale (Hedges' g = 0.882), Beck Depression Inventory II (g = 0.684), Rivermead Post-concussion Symptom Questionnaire chronic (g = 0.611), and somatic (g = 0.597) symptoms, and experiencing lower normalized wake after sleep onset (g = 0.667) than those in the amber light therapy group. In addition, individuals in the blue light therapy group experienced greater total sleep time (g = 0.529) and reported improved Functional Outcomes of Sleep Questionnaire scores (g = 0.929) than those in the amber light therapy group.
CONCLUSION


Daytime sleepiness, fatigue, and sleep disruption are common following a mild traumatic brain injury. These findings further substantiate blue light therapy as a promising nonpharmacological approach to improve these sleep-related complaints with the added benefit of improved postconcussion symptoms and depression severity.",2020,"In addition, individuals in the blue light therapy group experienced greater total sleep time (g = 0.529) and reported improved Functional Outcomes of Sleep Questionnaire scores (g = 0.929) than those in the amber light therapy group.
","['mild traumatic brain injury', 'Adults aged 18 to 45 years with a mild traumatic brain injury within the past 18 months (n = 35']","['placebo amber light therapy', 'Placebo', 'Daily Morning Blue Light Therapy']","['total sleep time', 'Functional Outcomes of Sleep Questionnaire scores', 'Rivermead Post-concussion Symptom Questionnaire chronic', 'Epworth Sleepiness Scale', 'Daytime Sleepiness, Sleep Quality, and Quality of Life', 'Daytime sleepiness, fatigue, and sleep disruption', 'Beck Depression Inventory', 'Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Beck Depression Inventory II, Rivermead Post-concussion Symptom Questionnaire, Functional Outcomes of Sleep Questionnaire, and actigraphy-derived sleep measures']","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242864', 'cui_str': 'Amber'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0365647,"In addition, individuals in the blue light therapy group experienced greater total sleep time (g = 0.529) and reported improved Functional Outcomes of Sleep Questionnaire scores (g = 0.929) than those in the amber light therapy group.
","[{'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Raikes', 'Affiliation': 'The Center for Innovation in Brain Science, The University of Arizona, Tucson (Dr Raikes); Social, Cognitive, and Affective Neuroscience (SCAN) Lab, Department of Psychiatry, College of Medicine, The University of Arizona, Tucson (Drs Dailey, Shane, and Killgore and Ms Forbeck); and Department of Psychiatry, College of Medicine, The University of Arizona, Tucson (Dr Alkozei).'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Dailey', 'Affiliation': ''}, {'ForeName': 'Bradley R', 'Initials': 'BR', 'LastName': 'Shane', 'Affiliation': ''}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Forbeck', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Alkozei', 'Affiliation': ''}, {'ForeName': 'William D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000579']
2812,32472840,Effectiveness of the Brains Ahead! Intervention: 6 Months Results of a Randomized Controlled Trial in School-Aged Children With Mild Traumatic Brain Injury.,"OBJECTIVE


To examine the effectiveness of Brains Ahead!, a psychoeducational intervention aimed to prevent long-term problems with activities and participation in children after mild traumatic brain injury (mTBI).
PARTICIPANTS


In total, 124 children, aged 6 to 18 years, diagnosed with mTBI and their caregivers.
METHOD


After randomization, participants in the intervention group received a face-to-face psychoeducational session with written take-home information and follow-up telephone call(s). Participants in the control group received usual care, consisting of a concise information brochure.
PRIMARY OUTCOME MEASURES


Activities and participation (Child and Adolescent Scale of Participation [CASP]).
SECONDARY OUTCOMES


fatigue, postconcussive symptoms (PCSs), posttraumatic stress symptoms (PTSSs), and quality of life (QOL).
RESULTS


Generalized Estimated Equation analyses showed that both groups improved over the first 6 months post-mTBI, but the intervention group did not differ significantly on the CASP. Mann-Whitney U tests showed that the intervention group reported significantly less fatigue, PCSs, and PTSSs and better QOL compared with the control group at 6 months post-MTBI.
CONCLUSIONS


The Brains Ahead! intervention resulted in significant improvements compared with usual care in reducing fatigue, PCSs, and PTSSs and improving QOL. Lack of an effect on activities and participation may be due to the ceiling effect of the CASP.",2020,"Mann-Whitney U tests showed that the intervention group reported significantly less fatigue, PCSs, and PTSSs and better QOL compared with the control group at 6 months post-MTBI.
","['School-Aged Children', '124 children, aged 6 to 18 years, diagnosed with mTBI and their caregivers', 'children after mild traumatic brain injury (mTBI']","['Intervention', 'usual care, consisting of a concise information brochure', 'face-to-face psychoeducational session with written take-home information and follow-up telephone call(s']","['Activities and participation ', 'fatigue, PCSs, and PTSSs and better QOL', 'Child and Adolescent Scale of Participation [CASP', 'fatigue, PCSs, and PTSSs and improving QOL', 'fatigue, postconcussive symptoms (PCSs), posttraumatic stress symptoms (PTSSs), and quality of life (QOL']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4511417', 'cui_str': 'Child and Adolescent Scale of Participation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",124.0,0.0869983,"Mann-Whitney U tests showed that the intervention group reported significantly less fatigue, PCSs, and PTSSs and better QOL compared with the control group at 6 months post-MTBI.
","[{'ForeName': 'M Irene', 'Initials': 'MI', 'LastName': 'Renaud', 'Affiliation': ""Revant Rehabilitation Centre, Breda, the Netherlands (Drs Renaud, van de Port, and Lambregts); Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, the Netherlands (Drs Renaud and van Heugten); Limburg Brain Injury Center, Maastricht, the Netherlands (Drs Renaud and van Heugten); Departments of Paediatric Neurology (Dr Catsman-Berrevoets) and Rehabilitation Medicine (Dr Lambregts), Erasmus University Hospital/Sophia Children's Hospital, Rotterdam, the Netherlands; and Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre+, Maastricht, the Netherlands (Drs Köhler and van Heugten).""}, {'ForeName': 'Ingrid G L', 'Initials': 'IGL', 'LastName': 'van de Port', 'Affiliation': ''}, {'ForeName': 'Coriene E', 'Initials': 'CE', 'LastName': 'Catsman-Berrevoets', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': ''}, {'ForeName': 'Suzanne A M', 'Initials': 'SAM', 'LastName': 'Lambregts', 'Affiliation': ''}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'van Heugten', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000583']
2813,32472874,The Efficacy of Electro-Acupuncture Added to Standard Therapy in the Management of Bell Palsy.,"OBJECTIVE


To investigate the comparative efficacy of electro-acupuncture when added to standard therapy in patients with Bell palsy in terms of clinical and neurophysiologic outcomes.
METHODS


A total of 88 patients with Bell palsy who received standard treatment (ST group; n = 40, mean ± standard deviation age: 39.2 ± 6.6 years, 60.0% were males) or standard treatment plus electro-acupuncture (ST-EA group; n = 48, mean ± standard deviation age: 39.5 ± 6.9 years, 58.3% were males) were included. Data on patient demographics, symptoms, comorbidities, and 3-month outcomes on treatment response assessed via House-Brackmann grading system and facial nerve recovery profile and electromyography were recorded.
RESULTS


Application of ST-EA versus ST was associated with a significantly higher rate of normal nerve function on 12th week electromyography (66.7% versus 25.0%, P = 0.020), higher frequency of patients with House-Brackmann grade ≤2 in the 3rd week (79.2% versus 45.0%, P = 0.029), 6th week (87.5% versus 45.0%, P = 0.004), and 12th week (95.8% versus 50.0%, P = 0.001), and those with facial nerve recovery profile scores ≥8 in the 6th week (83.3% versus 45.0%, P = 0.011) and 12th week (87.5% versus 50.0%, P = 0.009) of treatment.
CONCLUSION


In conclusion, our findings in patients with Bell palsy revealed superiority of electro-acupuncture added to standard therapy over standard therapy alone in terms of improvement of nerve dysfunction, decrease in paralysis severity, and better functional recovery. This seems to indicate the likelihood of electro-acupuncture to be a safe and promising adjunct in the achievement of more satisfactory clinical outcomes in the management of Bell palsy when used in combination with standard medical and physiotherapy.",2020,"RESULTS


Application of ST-EA versus ST was associated with a significantly higher rate of normal nerve function on 12th week electromyography (66.7% versus 25.0%, P = 0.020), higher frequency of patients with House-Brackmann grade ≤2 in the 3rd week (79.2% versus 45.0%, P = 0.029), 6th week (87.5% versus 45.0%, P = 0.004), and 12th week (95.8% versus 50.0%, P = 0.001), and those with facial nerve recovery profile scores ≥8 in the 6th week (83.3% versus 45.0%, P = 0.011) and 12th week (87.5% versus 50.0%, P = 0.009) of treatment.
","['88 patients with Bell palsy who received standard treatment (ST group; n\u200a=\u200a40, mean ± standard deviation age: 39.2\u200a±\u200a6.6 years, 60.0% were males) or', 'Bell Palsy', '58.3% were males) were included', 'patients with Bell palsy in terms of clinical and neurophysiologic outcomes']","['standard treatment plus electro-acupuncture (ST-EA group; n\u200a=\u200a48, mean\u200a±', 'electro-acupuncture', 'Electro-Acupuncture']","['facial nerve recovery profile scores ≥8', 'rate of normal nerve function', 'paralysis severity, and better functional recovery', 'patient demographics, symptoms, comorbidities, and 3-month outcomes on treatment response assessed via House-Brackmann grading system and facial nerve recovery profile and electromyography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",88.0,0.0815583,"RESULTS


Application of ST-EA versus ST was associated with a significantly higher rate of normal nerve function on 12th week electromyography (66.7% versus 25.0%, P = 0.020), higher frequency of patients with House-Brackmann grade ≤2 in the 3rd week (79.2% versus 45.0%, P = 0.029), 6th week (87.5% versus 45.0%, P = 0.004), and 12th week (95.8% versus 50.0%, P = 0.001), and those with facial nerve recovery profile scores ≥8 in the 6th week (83.3% versus 45.0%, P = 0.011) and 12th week (87.5% versus 50.0%, P = 0.009) of treatment.
","[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Gökçe Kütük', 'Affiliation': 'Department of Otorhinolaryngology, Aydin State Hospital.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Özkan', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Adnan Menderes University, Aydin.'}, {'ForeName': 'Muhammet Fatih', 'Initials': 'MF', 'LastName': 'Topuz', 'Affiliation': 'Department of Otorhinolaryngology, Evliya Çelebi Training and Research Hospital, Kütahya Medical Sciences University, Kütahya.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kütük', 'Affiliation': 'Department of Anesthesiology, Aydin State Hospital, Aydin, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006537']
2814,32472880,Outcomes of Treatment for Elderly Patients With Trigeminal Neuralgia: Percutaneous Balloon Compression Versus Microvascular Decompression.,"OBJECTIVE


The study aimed to evaluate the surgical outcomes of percutaneous balloon compression (PBC) and microvascular decompression (MVD) in the treatment of elderly patients with trigeminal neuralgia (TN).
METHODS


A total of 30 patients who underwent PBC surgery (PBC group) and 30 patients who received MVD surgery (MVD group) were included. The treatment efficacy, Barrow Neurological Institute (BNI) pain intensity score, inflammatory response, the rates of complication and recurrence were analyzed respectively.
RESULTS


The total efficacy was 93.33% in the PBC group and 90.00% in the MVD group (P > 0.05), respectively. The pain relief rate was 90.00% and 86.67% after PBC and MVD surgery, respectively (P > 0.05). The levels of IL-1β, TNF-α, and IL-6 were significantly decreased at post-operative 3 days and 5 days compared with pre-operation in the 2 groups (P < 0.05). The post-operative complication rates regarding masticatory muscle weakness and facial numbness in the PBC group were higher than MVD group (P < 0.05). Nevertheless, the incidences of herpes simplex and keratohelcosis were similar between the 2 groups (P > 0.05). The recurrence rates were also similar between the 3 groups (P > 0.05).
CONCLUSION


Percutaneous balloon compression and MVD are effective in the treatment for elderly TN, which can effectively improve the post-operative cure rate of pain prognosis and reduce the inflammatory response. However, PBC is a minimally invasive, safe and effective method for patients in poor general condition and refused treatment with craniotomy.",2020,"The levels of IL-1β, TNF-α, and IL-6 were significantly decreased at post-operative 3 days and 5 days compared with pre-operation in the 2 groups (P < 0.05).","['30 patients who underwent PBC surgery (PBC group) and 30 patients who received MVD surgery (MVD group) were included', 'Elderly Patients With Trigeminal Neuralgia', 'elderly patients with trigeminal neuralgia (TN']","['PBC', 'Balloon Compression Versus Microvascular Decompression', 'percutaneous balloon compression (PBC) and microvascular decompression (MVD']","['total efficacy', 'BNI) pain intensity score, inflammatory response', 'incidences of herpes simplex and keratohelcosis', 'pain relief rate', 'levels of IL-1β, TNF-α, and IL-6', 'masticatory muscle weakness and facial numbness', 'recurrence rates', 'rates of complication and recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3179067', 'cui_str': 'Microvascular Decompression Surgery'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0040997', 'cui_str': 'Trigeminal neuralgia'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0239511', 'cui_str': 'Numbness of face'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",30.0,0.0294876,"The levels of IL-1β, TNF-α, and IL-6 were significantly decreased at post-operative 3 days and 5 days compared with pre-operation in the 2 groups (P < 0.05).","[{'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': ""Department of Anesthesiology and Pain, Siyang People's Hospital, Siyang.""}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Department of Pain, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Nanjing.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Department of Pain, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Nanjing.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Emergency, Suqian People's Hospital of Nanjing Drum-Tower Hospital Group, Suqian, China.""}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006544']
2815,32472902,CHARACTERIZATION OF UNEXPECTED SURVIVORS FOLLOWING A PREHOSPITAL PLASMA RANDOMIZED TRIAL.,"BACKGROUND


Prehospital plasma improves survival for severely injured trauma patients transported by air ambulance. We sought to characterize the unexpected survivors, patients who survived despite having high predicted mortality following traumatic injury.
METHODS


The Prehospital Air Medical Plasma (PAMPer) trial randomized severely injured patients (n=501) to receive either standard care (crystalloid) or two units of prehospital plasma followed by standard care fluid resuscitation. We built a generalized linear model to estimate patient mortality. Area under the receiver operating characteristic curve (AUC) was used to evaluate model performance. We defined unexpected survivors as patients who had a predicted mortality >50% and survived to 30 days. We characterized patient demographics, clinical features, and outcomes of the unexpected survivors. Observed to expected (O/E) ratios and Z-statistics were calculated using model-estimated mortality for each cohort.
RESULTS


Our model predicted mortality better than ISS or RTS parameters and identified 36 unexpected survivors. Compared to expected survivors, unexpected survivors were younger (33 [24, 52] vs. 47 [32, 59] years, P=0.013), were more severely injured (ISS 34 [22, 50] vs. 18 [10, 27], P<0.001), had worse organ dysfunction and hospital resource outcomes (MOF, ICU and hospital length of stay, and ventilator days), and were more likely to receive prehospital plasma (67 vs. 46%, P=0.031). Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (P<0.001). Unexpected survivors who received prehospital plasma had a lower observed to expected mortality than those that received standard care resuscitation (O/E 0.56 [0.33-0.84] vs. 1.0 [0.73-1.32]). The number of prehospital plasma survivors (24) exceeded the number of predicted survivors (n=10) estimated by our model (P<0.001).
CONCLUSIONS


Prehospital plasma is associated with an increase in the number of unexpected survivors following severe traumatic injury. Prehospital interventions may improve the probability of survival for injured patients with high predicted mortality based on early injury characteristics, vital signs, and resuscitation measures.Secondary Analysis LEVEL OF EVIDENCE: II.",2020,Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (P<0.001).,"['The Prehospital Air Medical Plasma (PAMPer) trial randomized severely injured patients (n=501) to receive either', 'patients who survived despite having high predicted mortality following traumatic injury', 'severely injured trauma patients transported by air ambulance']",['standard care (crystalloid) or two units of prehospital plasma followed by standard care fluid resuscitation'],"['probability of survival', 'number of prehospital plasma survivors', 'survival', 'mortality', 'prehospital plasma', 'worse organ dysfunction and hospital resource outcomes (MOF, ICU and hospital length of stay, and ventilator days']","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0206185', 'cui_str': 'Air transport ambulance'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.107682,Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (P<0.001).,"[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Gruen', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Knoxville, TN.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': 'Department of Surgery, Univ. of Texas Southwestern, Parkland Memorial Hospital, Dallas, TX.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': 'University of Pittsburgh Department of Pathology, Pittsburgh, PA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, PA.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002816']
2816,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND


Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities.
METHODS


Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response.
RESULTS


We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus.
LIMITATIONS


Only young Chinese males without any trauma experience were recruited in this study.
CONCLUSIONS


The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123']
2817,32469819,Short and Long-Term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder.,"BACKGROUND


Many individuals use cannabis to manage symptoms of post-traumatic stress disorder (PTSD), and evidence indicates that the endocannabinoid system represents a viable target for treating these symptoms.
METHOD


Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time. This sample collectively used the app 11,797 times over 31 months to track PTSD-related symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety) immediately before and after inhaling cannabis. Latent change score models were used to examine changes in symptom severity and predictors of these changes (gender, dose, cannabis constituents, time). Multilevel models were used to explore long-term consequences of repeatedly using cannabis to manage these symptoms.
RESULTS


All symptoms were reduced by more than 50% immediately after cannabis use. Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions. Higher doses of cannabis predicted larger reductions in intrusions and anxiety, and dose used to treat anxiety increased over time. Baseline severity of all symptoms remained constant across time.
LIMITATIONS


The sample was self-selected, self-identified as having PTSD, and there was no placebo control group.
CONCLUSIONS


Cannabis provides temporary relief from PTSD-related symptoms. However, it may not be an effective long-term remedy as baseline symptoms were maintained over time and dose used for anxiety increased over time, which is indicative of development of tolerance.",2020,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","['Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time']",['Cannabis'],"['intrusions and irritability', 'symptom relief', 'intrusions and anxiety, and dose used to treat anxiety', 'symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety']","[{'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}]",,0.0308863,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Glodosky', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'The University of Pennsylvania Perelman School of Medicine, Department of Psychiatry, 3535 Market Street, Suite 500, Philadelphia, PA 19104.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.132']
2818,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES


Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults.
METHODS


Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual.
RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)].
DISCUSSION


The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054']
2819,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND


Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD.
METHODS


Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention.
RESULTS


The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected.
LIMITATIONS


The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study.
CONCLUSIONS


Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007']
2820,32469839,Feasibility and acceptability study of a video narratives intervention among post-stroke survivors.,"BACKGROUND


A large number of the world's post-stroke survivors suffers with moderate to severe disability. Long-term uncontrolled stroke risk factor led to unforeseen recurrent stroke and growing number of stroke occurrence across ages predominantly among the aging group in Malaysia. This situation has led to research works tapping into patient education especially related to the self-efficacy of understanding and taking medication appropriately. Video narratives integrated with Health Belief Model (HBM) constructs have displayed potential impact as an aide to patient education efforts.
OBJECTIVE


This study aimed to investigate the feasibility and acceptability of study procedures based on a trial protocol of video narratives intervention among post-stroke patients. We also report the preliminary findings of video narratives on medication understanding and use self-efficacy (MUSE) and blood pressure (BP) control.
METHODS


A parallel group randomized controlled study of a control group (without video-viewing) and an intervention group (with video viewing), was conducted by researchers at the neurology outpatient clinic on post-stroke patients (N=54). Baseline data included patients' socio-demographics, medical information and all outcome measures. Post measurement of MUSE and BP were done during 3 months' follow-up. Feasibility of study included recruitment and study completion rate with patients' feedback on the burden of study procedures and outcome measures. Whereas, acceptability of study was analyzed qualitatively. Statistical analysis was applied to ascertain preliminary results of the video narratives.
RESULTS


The recruitment rate was 60 out of 117 patients (51.3%). Nevertheless, the dropout rate of 10% was within the acceptable range. Patients were aged between 21 and 74 years. Nearly 50 of them (>85%) had adequate health literacy and exposure to stroke education. Most patients (> 80%) were diagnosed with ischemic stroke whereby the majority were primarily hypertensive. The technicality of randomization and patient approach were carried out with minimal challenge and adequate patient satisfaction. The video contents received good responses about its comprehension and simplicity. Moreover, an in-depth phone interview with 8 patients found the video narratives useful and inspiring. These findings also paralleled significant preliminary improvement in MUSE and systolic BP control (P<.05).
CONCLUSIONS


The queries and feedback from each phase in this study had been acknowledged and thus, would be taken forward to the full randomized controlled trial (RCT).
CLINICALTRIAL


UTN1111-1201-3955, ACTRN 12618000174280.",2020,"These findings also paralleled significant preliminary improvement in MUSE and systolic BP control (P<.05).
","['post-stroke survivors', 'post-stroke patients', 'Patients were aged between 21 and 74 years', 'Most patients (> 80%) were diagnosed with ischemic stroke whereby the majority were primarily hypertensive', 'researchers at the neurology outpatient clinic on post-stroke patients (N=54']","['video narratives intervention', 'control group (without video-viewing) and an intervention group (with video viewing', 'Video narratives integrated with Health Belief Model (HBM']","['dropout rate', 'MUSE and systolic BP control (P<.05', 'recruitment rate', 'adequate health literacy and exposure to stroke education', 'medication understanding and use self-efficacy (MUSE) and blood pressure (BP) control']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4303794', 'cui_str': 'Education about stroke'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",117.0,0.0700293,"These findings also paralleled significant preliminary improvement in MUSE and systolic BP control (P<.05).
","[{'ForeName': 'Jamuna Rani', 'Initials': 'JR', 'LastName': 'Appalasamy', 'Affiliation': 'School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, Selangor,, MY.'}, {'ForeName': 'Joyce Pauline', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of Neurology,, Hospital Kuala Lumpur, Ministry of Health,, Kuala Lumpur, MY.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Seeta Ramaiah', 'Affiliation': 'Medical Department,, Subang Jaya Medical Center,, Sunway, MY.'}, {'ForeName': 'Anuar Zaini', 'Initials': 'AZ', 'LastName': 'Md Zain', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences,, Monash University Malaysia,, Bandar Sunway, Selangor,, MY.'}, {'ForeName': 'Kia Fatt', 'Initials': 'KF', 'LastName': 'Quek', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences,, Monash University Malaysia,, Bandar Sunway, Selangor, MY.'}, {'ForeName': 'Kyi Kyi', 'Initials': 'KK', 'LastName': 'Tha', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences,, Monash University Malaysia,, Bandar Sunway, Selangor,, MY.'}]",JMIR aging,['10.2196/17182']
2821,32469850,General concepts in biostatistics and clinical epidemiology: Experimental studies with randomized clinical trial design.,"In experimental studies, researchers apply an intervention to a group of study participants and analyze the effects over a future or prospective timeline. The prospective nature of these types of studies allows for the determination of causal relationships, but the interventions they are based on require rigorous bioethical evaluation, approval from an ethics committee, and registration of the study protocol prior to implementation. Experimental research includes clinical and preclinical testing of a novel intervention or therapy at different phases of development. The main objective of clinical trials is to evaluate an interventions efficacy and safety. Conventional clinical trials are blinded, randomized, and controlled, meaning that participants are randomly assigned to either the study intervention group or a comparator (a control group exposed to a placebo intervention or another non-placebo or active interventionor not exposed to any intervention) to reduce selection and confounding biases, and researchers are also unaware of the type of intervention being applied. Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time). A quasi-experimental design and external controls may also be used. Metrics used to measure the magnitude of effects include relative risk, absolute and relative risk reductions, and numbers needed to treat and harm. Confounding factors are controlled by randomization. Other types of bias to consider are selection, performance, detection, and reporting. This review is the fifth of a methodological series on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile. It describes general theoretical concepts related to randomized clinical trials and other experimental studies in humans, including fundamental elements, historical development, bioethical issues, structure, design, association measures, biases, and reporting guidelines. Factors that should be considered in the execution and evaluation of a clinical trial are also covered.",2020,Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time).,['biostatistics and clinical epidemiology'],['placebo intervention or another non-placebo or active interventionor not exposed to any intervention'],"['relative risk, absolute and relative risk reductions, and numbers needed to treat and harm']","[{'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",,0.0875989,Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time).,"[{'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Estrada', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Arancibia', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Stojanova', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Papuzinski', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}]",Medwave,['10.5867/medwave.2020.02.7869']
2822,32469870,"Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial.","Obtaining a nutrient-rich diet during pregnancy is a challenge for pregnant women living in low-income countries. This randomized, controlled trial was designed to determine if a freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables given prior to and/or during pregnancy improved birth outcomes in rural Vietnamese women. Primiparous women, 18 to 30 years of age, who participated in the study were assigned to one of three groups: PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care. Supplement intake was observed and quantified. Infant anthropometry was measured at birth and/or within seven days of delivery. The effect of the intervention on maternal and birth outcomes was determined using linear regression modeling. Of the 460 women enrolled in the study, 317 women completed the study. Those not completing the study had either moved from the area, did not conceive within 12 months of study enrollment, or miscarried. The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups. However, it failed to alter infant anthropometric measurements at birth. In the entire cohort, maternal gestational weight gain was greater in women with a low pre-pregnancy BMI (<18.5) and in women with a higher educational attainment. Working as a farmer reduced gestational weight gain but it did not affect birth weight or length. In summary, a nutrient-rich, food-based supplement given to rural Vietnamese women from pre-conception to term or mid-gestation to term did not affect maternal or infant outcomes. The low weight gains, possibly due to demanding farm work done throughout the reproductive cycle, may have obviated any effects of the low energy, nutrient-rich food supplement on birth outcomes. Trial registration : Registered Clinical Trials.gov: NCT01235767.",2020,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","['rural Vietnamese women', 'pregnant women living in low-income countries', 'Primiparous women, 18 to 30 years of age, who participated in the study', 'rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes', '460 women enrolled in the study, 317 women completed the study']","['freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables', 'nutrient-rich, food-based supplement', 'nutrient-rich diet', 'PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care']","['protein, iron, zinc, folate, vitamin A and B12 intakes', 'maternal gestational weight gain', 'low weight gains', 'gestational weight gain', 'maternal and birth outcomes', 'birth weight or length']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0231246', 'cui_str': 'Failure to gain weight'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",317.0,0.162934,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","[{'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Nguyen T', 'Initials': 'NT', 'LastName': 'Diep Anh', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232197']
2823,32469881,"Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial.","BACKGROUND


Distal radius fractures are common fractures and the cornerstone of treatment remains immobilization of the wrist in a cast. At present, there is a scarcity of studies that compare different cast immobilization methods. The objective of the study was therefore to compare volar-flexion and ulnar deviation cast to functional cast position in the treatment of dorsally displaced distal radius fracture among elderly patients.
METHODS AND FINDINGS


We performed a pragmatic, randomized, controlled trial in three emergency centers in Finland. After closed reduction of the fracture, the wrist was placed in either volar-flexion and ulnar deviation cast or functional cast position. The follow-up was 12 months. The primary outcome was patient-rated wrist evaluation (PRWE) score at 12 months. The secondary outcomes were Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale. The number of complications was also recorded. In total, 105 participants were included in the study. Of these, 88% were female and the mean age was 73.5 (range 65-94) years. In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9 (95% CI: -13.1.- 3.4., p = .24) in favor of the functional cast position. Operative treatment due to loss of reduction of fracture was performed for four patients (8%) in the FC group and for seven patients (13%) in the volar-flexion and ulnar deviation cast group (OR: 0.63, 95% CI: 0.16-2.1).
CONCLUSION


In this study, the data were consistent with a wide range of treatment effects when comparing two different cast positions in the treatment of distal radius fracture among elderly patients at 12-month follow-up. However, the functional cast is more likely to be superior when compared to volar-flexion and ulnar deviation cast.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02894983 Accessible: https://clinicaltrials.gov/ct2/show/NCT02894983.",2020,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","['88% were female and the mean age was 73.5 (range 65-94) years', 'dorsally displaced distal radius fracture among elderly patients', '105 participants were included in the study', ""patients with Colles' fracture"", 'three emergency centers in Finland']",['volar-flexion and ulnar deviation cast to functional cast position'],"['Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale', 'patient-rated wrist evaluation (PRWE) score', 'patient-rated wrist evaluation measure', 'number of complications', 'reduction of fracture', 'distal radius fracture']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009353', 'cui_str': ""Colles' fracture""}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",105.0,0.170183,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Raittio', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti P', 'Initials': 'AP', 'LastName': 'Launonen', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Hevonkorpi', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Luokkala', 'Affiliation': 'Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Reito', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Minna K', 'Initials': 'MK', 'LastName': 'Laitinen', 'Affiliation': 'Division of Orthopaedics and Traumatology, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",PloS one,['10.1371/journal.pone.0232153']
2824,32469893,Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial.,"INTRODUCTION


Intramuscular electroporation (IM/EP) is a vaccine delivery technique that improves the immunogenicity of DNA vaccines. We evaluated the acceptability and tolerability of electroporation among healthy African study participants.
METHODS


Forty-five participants were administered a DNA vaccine (HIV-MAG) or placebo by electroporation at three visits occurring at four week-intervals. At the end of each visit, participants were asked to rate pain at four times: (1) when the device was placed on the skin and vaccine injected, before the electrical stimulation, (2) at the time of electrical stimulation and muscle contraction, and (3) at 10 minutes and (4) 30 minutes after the procedure was completed. For analyses, pain level was dichotomized as either ""acceptable"" (none/slight/uncomfortable) or ""too much"" (Intense, severe, and very severe) and examined over time using repeated measures models. Optional brief comments made by participants were summarized anecdotally.
RESULTS


All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure. Most (76%) reported pain levels as acceptable at every time point across all vaccination visits. The majority of ""unacceptable"" pain was reported at the time of electrical stimulation. The majority of the participants (97%) commented that they preferred electroporation to standard injection.
CONCLUSION


Repeated intramuscular electroporation for vaccine delivery was found to be acceptable and feasible among healthy African HIV vaccine trial participants. The majority of participants reported an acceptable pain level at all vaccination time points. Further investigation may be warranted into the value of EP to improve immunization outcomes. ClinicalTrials.gov NCT01496989.",2020,The majority of participants reported an acceptable pain level at all vaccination time points.,"['All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure', 'Forty-five participants', 'healthy African participants', 'healthy African study participants', 'healthy African HIV vaccine trial participants']","['DNA vaccine (HIV-MAG) or placebo', 'repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine', 'Intramuscular electroporation (IM/EP']","['Acceptability and tolerability', 'acceptability and tolerability of electroporation', 'pain level', 'rate pain', 'pain levels', 'acceptable pain level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",45.0,0.16596,The majority of participants reported an acceptable pain level at all vaccination time points.,"[{'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mpendo', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Gaudensia', 'Initials': 'G', 'LastName': 'Mutua', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanvubya', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Omu', 'Initials': 'O', 'LastName': 'Anzala', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Nyombayire', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'EMMES Corporation, Rockville, Maryland, United States of America.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems, Inc., San Diego, California, United States of America.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Fast', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Hills', 'Affiliation': 'University of California at San Francisco, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233151']
2825,32469906,"Training intervention to improve hygiene practices in Islamic boarding school in Yogyakarta, Indonesia: A mixed-method study.","BACKGROUND


The primary objective of this study was to determine the effect of a training intervention in overall improvement in students' (santris) knowledge, behavior, and outcome.
METHODS


A mixed-methods exploratory sequential design was applied. First, qualitative data were collected from three focus group discussions with 20 supervisors and one in-depth interview with school principal to explore current hygiene practices. The information was then used to develop training intervention using either video, poster, and leaflet. To measure the effect, a stepped wedge cluster design with pre- and post-test analyses was conducted. A total of 452 junior high school santris in one Islamic boarding school were non-randomly allocated to either three intervention groups. Outcome measures were knowledge, personal behavior, and room hygiene. Codes and categories were produced in the qualitative analysis, while paired t-tests and Wilcoxon rank tests test were used in the quantitative analysis.
RESULTS


The qualitative study identified poor practices on personal and room hygiene among the santris and proposed a training intervention. Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001). Room hygiene was significantly improved among boys and those who received leaflets.
CONCLUSION


Having developed a specific training materials, school-based hygiene training intervention improved knowledge and personal behavior. Its effect on room hygiene particularly for female santris needs further strengthening of the intervention in this Islamic boarding school setting.",2020,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","['Islamic boarding school in Yogyakarta, Indonesia', '452 junior high school santris in one Islamic boarding school']","['training intervention', 'Training intervention']","[""overall improvement in students' (santris) knowledge, behavior, and outcome"", 'knowledge and personal behavior', 'Room hygiene', 'knowledge, personal behavior, and room hygiene']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",452.0,0.0218919,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Widyasari', 'Affiliation': 'International Health, Public Health Graduate Program, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yayi Suryo', 'Initials': 'YS', 'LastName': 'Prabandari', 'Affiliation': 'Department of Health Behavior, Environment, and Social Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",PloS one,['10.1371/journal.pone.0233267']
2826,32469920,Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation.,"INTRODUCTION


Simulation is a powerful tool for training and evaluating clinicians. However, few studies have examined the consistency of actor performances during simulation based medical education (SBME). The Simulated Communication with ICU Proxies trial (ClinicalTrials.gov NCT02721810) used simulation to evaluate the effect of a behavioral intervention on physician communication. The purpose of this secondary analysis of data generated by the quality assurance team during the trial was to assess how quality assurance monitoring procedures impacted rates of actor errors during simulations.
METHODS


The trial used rigorous quality assurance to train actors, evaluate performances, and ensure the intervention was delivered within a standardized environment. The quality assurance team evaluated video recordings and documented errors. Actors received both timely, formative feedback and participated in group feedback sessions.
RESULTS


Error rates varied significantly across three actors (H(2) = 8.22, p = 0.02). In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
CONCLUSIONS


Rigorous quality assurance procedures may help ensure consistent actor performances during SBME.",2020,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
",[],"['Actor feedback and rigorous monitoring', 'behavioral intervention']","['incidence of actor error over time, and errors', 'Error rates']",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0672195,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
","[{'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Abshire', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Teply', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States of America.'}, {'ForeName': 'Arun L', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': ""Division of Pediatric Palliative Medicine, Prisma Health Children's Hopsital - Upstate, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, United States of America.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0233538']
2827,32469922,The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression.,"BACKGROUND


Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation.
METHODS


Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff.
RESULTS


Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety.
CONCLUSIONS


A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.",2020,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"['people with complex anxiety and depression in secondary mental health services', 'people with complex anxiety or depression', 'Forty participants were recruited in four months from 65 eligible potential participants asked', 'people with mental health problems', 'adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services', 'Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the']","['Community Navigator programme over six months in addition to routine care (n = 30); or routine care', 'Community Navigator programme']","['Acceptability and feasibility', 'loneliness and depression and anxiety', 'effectiveness and cost-effectiveness', 'loneliness, depression, other clinical and social outcomes and service use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",40.0,0.205116,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frerichs', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Stefanidou', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Chhapia', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Chipp', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Prisha', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shorten', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giorgalli', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Terhune', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0233535']
2828,32469946,Training specificity performing single-joint vs. multi-joint resistance exercises among physically active females: A randomized controlled trial.,"Resistance-training of the lower limbs can be performed using exercises moving one (single-joint exercises) or several joints (multi-joint exercises). This study compared the effects of training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback) on dynamic and isometric strength and the transferability of dynamic strength between exercises. Fifty-three physically active women were randomized to a multi-joint (MJ) training group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20), single-joint (SJ) training group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15). The training groups participated in an 8-week supervised single- or multi-joint lower limb training consisting of 18 sessions. Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction in the three exercises were assessed, along with electromyography of the superficial quadriceps muscles. Improvements in all dynamic exercises were greatest after training the specific exercises (ES = 1.26-2.14, P<0.001-0.025) and all were greater in the training groups than in the CON group (ES = 1.43-3.31, P<0.001-0.021). The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002). However, leg press and leg extension strength improved similarly in the MJ group (ES = 0.54, P = 0.072). All strength and electromyographic measures remained unchanged in the CON group (ES = 0.00-0.44, P = 0.412-0.966). Improved dynamic strength in leg press, kickback and leg extension is best attained by training the specific exercises, but both training modalities can improve strength across all exercises.",2020,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","['group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15', 'Fifty-three physically active women', 'group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20', 'physically active females']","['multi-joint (MJ) training', 'Training specificity performing single-joint vs. multi-joint resistance exercises', 'Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction', 'single-joint (SJ) training', 'SJ', '8-week supervised single- or multi-joint lower limb training consisting of 18 sessions', 'training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback']","['6RM in leg extension and kickback', 'dynamic strength in leg press, kickback and leg extension', 'leg press 6RM', 'All strength and electromyographic measures', 'leg press and leg extension strength']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556502', 'cui_str': 'Lower limb training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.0304002,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","[{'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Aril Hagen', 'Initials': 'AH', 'LastName': 'Ravnøy', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0233540']
2829,32470022,Peripheral endothelial function can be improved by daily consumption of water containing over 7 ppm of dissolved hydrogen: A randomized controlled trial.,"BACKGROUND


Measurement of the reactive hyperemia index (RHI) using peripheral arterial tonometry (PAT) has shown benefits in the evaluation of vascular endothelial function and prediction of cardiovascular disease prognosis. Thus, it is important to examine the factors that promote the RHI. In this study, we aimed to investigate the effect of molecular hydrogen (H2) on reactive hyperemia-PAT of the small arteries of fingers in healthy people.
METHODS


To determine the efficacy of H2 for improving peripheral vascular endothelial function, water containing high H2 concentrations was administered to participants, and the Ln_RHI was measured in the finger vasculature. Sixty-eight volunteers were randomly divided into two groups: a placebo group (n = 34) that drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water). The Ln_RHI was measured before ingesting the placebo or high H2 water, 1 h and 24 h after the first ingestion, and 14 days after daily ingestion of high H2 water or the placebo. The mixed effects model for repeated measures was used in data analysis.
RESULTS


The high H2 group had a significantly greater improvement in Ln_RHI than the placebo group. Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
CONCLUSIONS


Daily consumption of high H2 water improved the endothelial function of the arteries or arterioles assessed by the PAT test. The results suggest that the continuous consumption of high H2 water contributes to improved cardiovascular health.",2020,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
","['Sixty-eight volunteers', 'healthy people']","['molecular hydrogen (H2', 'peripheral arterial tonometry (PAT', 'drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water', 'placebo']","['endothelial function', 'Ln_RHI', 'cardiovascular health', 'peripheral vascular endothelial function, water containing high H2 concentrations', 'Peripheral endothelial function']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.102059,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kawamoto', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kasumi', 'Initials': 'K', 'LastName': 'Matsuno', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Genki', 'Initials': 'G', 'LastName': 'Ishihara', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takamichi', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Department of Rheumatology, Orthopaedic Surgery and Health Care, Huis Ten Bosch Satellite H2 Clinic Hakata, Hakata-ku, Fukuoka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Komori', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0233484']
2830,32470089,A pilot randomized trial of incentive strategies to promote HIV retesting in rural Uganda.,"BACKGROUND


Retesting for HIV is critical to identifying newly-infected persons and reinforcing prevention efforts among at-risk adults. Incentives can increase one-time HIV testing, but their role in promoting retesting is unknown. We sought to test feasibility and acceptability of incentive strategies, including commitment contracts, to promote HIV retesting among at-risk adults in rural Uganda.
METHODS


At-risk HIV-negative adults were enrolled in a pilot trial assessing feasibility and acceptability of incentive strategies to promote HIV retesting three months after enrollment. Participants were randomized (1:1:3) to: 1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit) upon retesting or lost if participants failed to retest. Contracts sought to promote retesting by leveraging loss aversion and addressing present bias via pre-commitment. Outcomes included acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake.
RESULTS


Of 130 HIV-negative eligible adults, 123 (95%) enrolled and were randomized: 74 (60%) to commitment contracts, 25 (20%) to standard incentives, and 24 (20%) to no incentive. Of contract participants, 69 (93%) made deposits. Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
CONCLUSION


In a randomized trial of strategies to promote HIV retesting among at-risk adults in Uganda, incentive strategies, including commitment contracts, were feasible and had high acceptability. Our findings suggest use of incentives for HIV retesting merits further comparison in a larger trial.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT:02890459.",2020,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","['risk adults in rural Uganda', 'At-risk HIV-negative adults', '130 HIV-negative eligible adults, 123 (95%) enrolled', 'HIV retesting in rural Uganda']",['1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit'],"['acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake', 'HIV: uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",130.0,0.175444,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Mbarara, Uganda.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Marson', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Devy M', 'Initials': 'DM', 'LastName': 'Emperador', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0233600']
2831,32470147,Effect of non-sedation on posttraumatic stress and psychological health in survivors of critical illness.,"BACKGROUND


Critical illness can cause posttraumatic stress and impaired mental health. The NONSEDA-trial was a Scandinavian multicenter RCT, assessing non-sedation versus sedation with a daily wake-up call during mechanical ventilation in critically ill adults. The aim of this sub-study was to assess the effect of non-sedation on posttraumatic stress and mental health.
METHODS


This sub-study is based on all participating patients from a single NONSEDA trial-site (Kolding, Denmark). Patients were randomised to sedation or non-sedation within the first 24 hours of mechanical ventilation. Three months after ICU-discharge survivors were examined by a neuropsychologist for posttraumatic stress, anxiety and depression, and filled out the SF-36 questionnaire regarding quality of life.
RESULTS


The two groups of survivors were similar with regard to baseline characteristics, length of admission and mechanical ventilation. Sedated patients received more propofol and midazolam. Doses of morphine and haloperidole were equal.
PRIMARY OUTCOME


the number of patients with posttraumatic stress disorder did not differ between groups (non-sedated: 2 patients vs sedated: 0, p=0.23).
SECONDARY OUTCOMES


There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
CONCLUSION


Levels of PTSD, anxiety and depression and quality of life regarding mental health were similar between the non-sedated and sedated group.",2020,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","['survivors of critical illness', 'critically ill adults', 'participating patients from a single NONSEDA trial-site (Kolding, Denmark']","['propofol and midazolam', 'morphine', 'non-sedation', 'sedation or non-sedation']","['Beck Anxiety Index', 'number of patients with symptoms of posttraumatic stress', 'Beck Depression Index', 'number of patients with posttraumatic stress disorder', 'PTSD, anxiety and depression and quality of life regarding mental health', 'posttraumatic stress and psychological health', 'SF-36 mental component score']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0854969,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","[{'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}, {'ForeName': 'Hanne I', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stylsvig', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}, {'ForeName': 'Hanne T', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13648']
2832,32470180,A Regions of Interest Voxel-based morphometry study of the human brain during high-frequency spinal cord stimulation in patients with Failed Back Surgery Syndrome.,"INTRODUCTION


The effectiveness of Spinal Cord Stimulation (SCS) as pain-relieving treatment for Failed Back Surgery Syndrome (FBSS) has already been demonstrated. However, potential structural and functional brain alterations resulting from subsensory SCS are less clear. The aim of this study is to test structural volumetric changes in a priori chosen regions of interest related to chronic pain after 1 month and 3 months of high-frequency SCS, in patients with FBSS.
METHODS


Eleven patients with FBSS, scheduled for SCS implantation were included in this study. All patients underwent a magnetic resonance imaging protocol before SCS implantation, 1 month and 3 months after high frequency SCS. Pain intensity, pain catastrophizing and sleep quality were also measured. Regions of Interest Voxel-based morphometry was used to explore GM volumetric changes over time. Additionally, volumetric changes were correlated with changes in pain intensity, catastrophizing and sleep quality.
RESULTS


Significant decreases were found in volume in the left and right hippocampus over time. More specifically, a significant difference was revealed between volumes before SCS implantation and after 3 months of SCS. Repeated measures correlations revealed a significant positive correlation between volumetric changes in the left hippocampus and changes in back pain score over time and between volumetric changes in the right hippocampus and changes in back pain score over time.
CONCLUSION


In patients with FBSS, high-frequency SCS influences structural brain regions over time. The volume of the hippocampus was decreased bilaterally after 3 months of high-frequency SCS with a positive correlation with back pain intensity.",2020,The volume of the hippocampus was decreased bilaterally after 3 months of high-frequency SCS with a positive correlation with back pain intensity.,"['patients with Failed Back Surgery Syndrome', 'Failed Back Surgery Syndrome (FBSS', 'Eleven patients with FBSS, scheduled for SCS implantation were included in this study', 'patients with FBSS']","['Spinal Cord Stimulation (SCS', 'magnetic resonance imaging protocol before SCS implantation']","['back pain score', 'Pain intensity, pain catastrophizing and sleep quality', 'chronic pain', 'volume of the hippocampus', 'pain intensity, catastrophizing and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",11.0,0.0776211,The volume of the hippocampus was decreased bilaterally after 3 months of high-frequency SCS with a positive correlation with back pain intensity.,"[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'De Groote', 'Affiliation': 'Department of neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goudman', 'Affiliation': 'Department of neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Linderoth', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Buyck', 'Affiliation': 'Department of neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'Spine & Neuromodulation Functional Unit, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'De Jaeger', 'Affiliation': 'Department of neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Schuerbeek', 'Affiliation': 'Department of Radiology, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Department of Radiology, Universitair Ziekenhuis Leuven, UZ Herestraat 49-bus, 7003 54, 3000, Leuven, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sunaert', 'Affiliation': 'Department of Radiology, Universitair Ziekenhuis Leuven, UZ Herestraat 49-bus, 7003 54, 3000, Leuven, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Moens', 'Affiliation': 'Department of neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12922']
2833,32470217,Randomized clinical trial to evaluate mometasone lavage vs spray for patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery.,"BACKGROUND


There is no consensus regarding the best route of intranasal delivery of corticosteroids in the treatment of chronic rhinosinusitis (CRS). The study objective of this work was to compare the impact of mometasone furoate nasal spray (MFNS) vs mometasone nasal irrigation in the management of CRS patients who have not undergone sinus surgery.
METHODS


A double-blind, placebo-controlled, randomized clinical trial was conducted in adults with CRS. Individuals with nasal polyps and/or history of sinus surgery were excluded. Patients were randomized to receive 8 weeks of either MFNS or mometasone nasal irrigation. The primary outcome measure was change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score between the 2 groups. Secondary outcome measures included patient global response to treatment and Lund-Kennedy endoscopy scores.
RESULTS


A total of 43 participants completed the study (n = 22, MFNS; n = 21,mometasone nasal irrigation). Fourteen (64%) participants in the MFNS group and 17 (81%) in the mometasone lavage group had a clinically meaningful improvement in SNOT-22 scores with a proportion difference of 17% (95% confidence interval [CI], -9% to 44%). The least-squares (LS) mean difference between the 2 groups for SNOT-22 was -8.6 (95% CI, -17.7 to 0.58; p = 0.07), whereas the LS mean difference between the 2 groups for Lund-Kennedy endoscopy scores was 0.16 (95% CI, -0.84 to 1.15; p = 0.75). No adverse events were associated with the study.
CONCLUSION


Both MFNS and mometasone nasal irrigations are beneficial in symptom management of CRS. Our study suggests that patients who perform mometasone lavage do better in a clinically meaningful way, but our results are not definitive and further studies are warranted.",2020,There is no consensus regarding the best route of intranasal delivery of corticosteroids in the treatment of chronic rhinosinusitis (CRS).,"['Individuals with nasal polyps and/or history of sinus surgery', '43 participants completed the study (n = 22, MFNS; n = 21,mometasone nasal irrigation', 'chronic rhinosinusitis (CRS', 'adults with CRS', 'patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery', 'CRS patients who have not undergone sinus surgery']","['MFNS and mometasone nasal irrigations', 'mometasone lavage vs spray', 'MFNS', 'corticosteroids', 'mometasone furoate nasal spray (MFNS) vs mometasone nasal irrigation', 'mometasone lavage', 'MFNS or mometasone nasal irrigation', 'placebo']","['patient global response to treatment and Lund-Kennedy endoscopy scores', 'Lund-Kennedy endoscopy scores', 'adverse events', '22-item Sino-Nasal Outcome Test (SNOT-22) score', 'SNOT-22 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0717925', 'cui_str': 'Mometasone-containing product in nasal dose form'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",43.0,0.259522,There is no consensus regarding the best route of intranasal delivery of corticosteroids in the treatment of chronic rhinosinusitis (CRS).,"[{'ForeName': 'Pawina', 'Initials': 'P', 'LastName': 'Jiramongkolchai', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Peterson', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Kallogjeri', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Jake J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kukuljan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Liebendorfer', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Schneider', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Cristine N', 'Initials': 'CN', 'LastName': 'Klatt-Cromwell', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Drescher', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}, {'ForeName': 'Jay F', 'Initials': 'JF', 'LastName': 'Piccirillo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St. Louis, MO.'}]",International forum of allergy & rhinology,['10.1002/alr.22586']
2834,32470230,Relationships Between Executive Function Improvement and ADHD Symptom Improvement With Lisdexamfetamine Dimesylate in Adults With ADHD and Executive Function Deficits: A Post Hoc Analysis.,"Objective


Executive function (EF) deficits are not generally considered synonymous with attention-deficit/hyperactivity disorder (ADHD). Evidence suggests stimulants improve ADHD symptoms and EF deficits in adults with ADHD, but the relationships between improvements in these domains have not been studied.
Methods


These post hoc analyses used data from a 10-week double-blind, placebo-controlled study of adults with ADHD and EF deficits treated with lisdexamfetamine dimesylate (30-70 mg) or placebo conducted from May 2010 to November 2010. Efficacy endpoints included change from baseline at week 10/early termination (ET) in self-report Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score and ADHD-Rating Scale with Adult Prompts total score (ADHD-RS-AP-TS). Relationships between ADHD symptom and EF changes were examined using recursive path analyses.
Results


Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85 [-9.83 to -3.86] and -11.12 [-14.88 to -7.37]) for self-report BRIEF-A GEC T-score change from baseline at week 10/ET on ADHD-RS-AP-TS change from baseline at week 10/ET and 0.93 (indirect and total treatment effect coefficients [95% CI]: -10.34 [-14.11 to -6.57] and -11.18 [-15.80 to -6.55]) for ADHD-RS-AP-TS change from baseline at week 10/ET on self-report BRIEF-A GEC T-score change from baseline at week 10/ET.
Conclusions


Although these data suggest ADHD symptom and EF deficit improvement following lisdexamfetamine are interdependent, it is advantageous to use measures like the BRIEF-A to assess stimulant effects on the wide range of EF deficits associated with ADHD that are not captured by the ADHD-RS-AP alone.
Trial Registration


Data used in this secondary analysis came from ClinicalTrials.gov identifier: NCT01101022.",2020,"Results


Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85","['adults with ADHD and EF deficits treated with', 'Adults With ADHD and Executive Function Deficits', 'adults with ADHD', 'conducted from May 2010 to November 2010']","['placebo', 'lisdexamfetamine', 'lisdexamfetamine dimesylate', 'Lisdexamfetamine Dimesylate']","['Objective\n\n\nExecutive function (EF) deficits', 'self-report BRIEF-A GEC T-score change', 'Global Executive Composite (GEC) T-score and ADHD-Rating Scale with Adult Prompts total score (ADHD-RS-AP-TS', 'ADHD symptoms and EF deficits', 'Executive Function Improvement and ADHD Symptom Improvement', 'change from baseline at week 10/early termination (ET) in self-report Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.127978,"Results


Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Brown', 'Affiliation': 'Brown Clinic for Attention & Related Disorders, 500 S Sepulveda Blvd, Ste 218, Manhattan Beach, CA 90266. tebrownyu@gmail.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a member of the Takeda group of companies, Lexington, Massachusetts; currently employed by Yumanity Therapeutics Inc, Cambridge, Massachusetts, USA.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02559']
2835,32470239,"Effect of nanohydroxyapatite associated with photobiomodulation in the control of dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical trial.","PURPOSE


To evaluate the effect of nanohydroxyapatite ( nHAP) associated with photobiomodulation (PBM) in the control of dentin hypersensitivity (DH). (C-Shape It).
METHODS


32 subjects with 83 hypersensitive teeth were randomized into four groups (N =8) : GPlacebo - simulated PBM (without light emission) followed by the application of nHAP-free toothpaste; GLaser - PBM followed by the application of nHAP-free toothpaste; GnHAP - simulated PBM followed by the application of nHAP; GLasernHAP - PBM followed by the application of nHAP. A visual analogue scale (VAS) was used to measure DH after a tactile and evaporative stimulus. DH evaluations were performed at four times: baseline, 1st, and 2nd treatment sessions, and 1 month. A questionnaire was used to evaluate the risk factors associated with DH intensity. Mixed-design ANOVA followed by Tukey test and logistic regression were used.
RESULTS


The mechanical stimulus showed a significant reduction in DH in all experimental groups (P< 0.05) at the 2nd treatment session. For the evaporative stimulus, the GLasernHAP group presented a significant reduction in DH at the 1st treatment session (P< 0.05). Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli. The variables of parafunctional habits, diets rich in acidic drinks and anxiety had significant relationships with the intensity of DH (P< 0.05).
CLINICAL SIGNIFICANCE


The use of nHAP and application of PBM to laser are effective in the control of dentin hypersensitivity. However, their association did not enhance the desensitizing effect.",2020,Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli.,"['32 subjects with 83 hypersensitive teeth', 'dentin hypersensitivity', 'dentin hypersensitivity (DH']","['nanohydroxyapatite', 'GnHAP', 'GLasernHAP', 'photobiomodulation (PBM', 'photobiomodulation', 'GPlacebo - simulated PBM (without light emission) followed by the application of nHAP-free toothpaste; GLaser - PBM followed by the application of nHAP-free toothpaste; GnHAP - simulated PBM followed by the application of nHAP; GLasernHAP - PBM', 'nanohydroxyapatite ( nHAP', 'placebo']","['DH', 'visual analogue scale (VAS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0645108', 'cui_str': 'N-hydroxy-2-aminopyrene'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",32.0,0.0213293,Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli.,"[{'ForeName': 'Cristiane deM', 'Initials': 'CD', 'LastName': 'Alencar', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazilcstewa32@uthsc.edu.'}, {'ForeName': 'Mariangela Ig', 'Initials': 'MI', 'LastName': 'Ortiz', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Eliane B', 'Initials': 'EB', 'LastName': 'Alves', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Jesuína Ln', 'Initials': 'JL', 'LastName': 'Araújo', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Cecy M', 'Initials': 'CM', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil, cecymsilva@gmail.com.'}]",American journal of dentistry,[]
2836,32470240,Marginal adaptation and internal indentation resistance of a Class II bulk-fill resin-based composite.,"PURPOSE


To compare the dentin bonded external marginal integrity and the internal surface indentation hardness of bulk-fill and conventional resin-based composite (RBC) placed in both bulk and increments.
METHODS


120 MO and DO cavities were prepared in 60 extracted human third molars. The teeth were randomly divided into four groups of 15 teeth per group to be restored as follows: BB (bulk-fill RBC, placed in a 4 mm bulk increment), BL (bulk-fill RBC, placed in 2 mm incremental layers), CB (conventional RBC, placed in a 4 mm bulk increment), and CL (conventional RBC, placed in 2 mm incremental layers). Marginal gaps were measured at mesial and distal dentin gingival cavosurfaces of each tooth using scanning electron microscopy of epoxy resin replicas and Knoop hardness (KHN) was measured at three different RBC depths (1.8, 2.8 and 3.8 mm). Statistical analyses included one-way ANOVA with post-hoc Tukey's HSD, and paired-sample t-test or a nonparametric Wilcoxon signed-rank test, as appropriate.
RESULTS


There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance). The mean RBC internal surface KHN at 1.8 mm depth was significantly greater than at 2.8 mm and 3.8 mm depths in all tested groups (P< 0.05 for all instances), with a similar mean internal hardness between all groups. The bulk-fill RBC restorations demonstrated similar marginal gap formation and Knoop hardness to conventional universal RBC restorations under the conditions of this study.
CLINICAL SIGNIFICANCE


Bulk-fill resin-based composite (RBC), from the perspective of marginal adaptation and internal hardness, may be a suitable alternative to conventional RBC.",2020,"There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance).",['120 MO and DO cavities were prepared in 60 extracted human third molars'],[],"['Marginal adaptation and internal indentation resistance', 'RBC restoration type on external marginal gap at the distal surface', 'mean RBC internal surface KHN', 'external marginal gap']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]",[],"[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0209519,"There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance).","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El Naga', 'Affiliation': 'Orthodontics Program, Georgia School of Orthodontics, Atlanta, Georgia, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qian', 'Affiliation': 'Division of Biostatistics and Computational Biology and Adjunct Faculty, Department of Preventive and Community Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Gerald E', 'Initials': 'GE', 'LastName': 'Denehy', 'Affiliation': 'Department of Operative Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Quock', 'Affiliation': 'Department of Restorative Dentistry & Prosthodontics, University of Texas School of Dentistry at Houston, Houston, Texas, USA, Ryan.Quock@uth.tmc.edu.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Armstrong', 'Affiliation': 'Department of Operative Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}]",American journal of dentistry,[]
2837,32470241,"Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.","PURPOSE


To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA).
METHODS


This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model.
RESULTS


85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
CLINICAL SIGNIFICANCE


The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.",2020,"The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
",['85 subjects completed the study and had fully evaluable data'],"['RF powered toothbrush or a control powered toothbrush', 'novel toothbrush utilizing RF energy', 'ToothWave radiofrequency (RF) toothbrush']","['plaque, calculus and gingival inflammation', 'oral health', 'Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI', 'plaque, gingivitis and calculus', 'safety and efficacy', 'Safety and efficacy', 'tolerated and no device-related adverse events', 'dental plaque, calculus deposition, gingival inflammation and gingival bleeding', 'plaque, calculus and gingivitis']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}]",85.0,0.0424656,"The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
","[{'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Levi', 'Affiliation': 'Home Skinovations, Ltd., Yokneam, Israel, lioral@silkn.com.'}, {'ForeName': 'Tori L', 'Initials': 'TL', 'LastName': 'Grahovac', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}, {'ForeName': 'Jeffery L', 'Initials': 'JL', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}]",American journal of dentistry,[]
2838,32470242,Influence of mechanical and chemical degradation on surface gloss of direct and CAD-CAM resin composite materials.,"PURPOSE


To compare the gloss retention of four resin based materials, two direct resin composites (Tetric EvoCeram and Filtek Supreme) and two indirect resin composite CAD-CAM blocks (Tetric CAD and Lava Ultimate).
METHODS


36 samples of 1 mm thickness were readied of each test material and manually polished with polishing discs (Sof-Lex) up to the finest grit size. Three gloss measurements per sample were taken (one every 120 degrees of sample rotation) by means of a glossmeter (Novo-Curve) for a total of 60 values obtained per tested material. Samples of each material were then randomly divided into three equal groups and aged with 75% alcohol (Group 1), amine fluoride gel (Elmex gelée) (Group 2) or mechanical brushing (Group 3). Another set of gloss measurements was performed on all samples after 1 hour of aging. Gloss values were statistically evaluated by means of repeated measures ANOVA and Fisher's LSD post-hoc tests.
RESULTS


Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing. Statistical analysis revealed: (1) significant difference between intial and final gloss values for all materials and groups; (2) significant difference between final gloss values of all the materials in the alcohol group; (3) significant difference between final gloss values of Lava Ultimate and all the other materials in the Elmex gelèe group; (4) significant difference between final gloss values of Lava Ultimate and Tetric CAD with the other tested materials in the brushing group.
CLINICAL SIGNIFICANCE


Direct resin composites in general are widely used, and CAD-CAM resin composite materials are becoming progressively more accessible. Making the choice between direct and indirect techniques is still a challenge, and understanding the advantages of CAD-CAM resin composites in the form of higher gloss retention, which translates into higher durability of esthetics, may be one the parameters facilitating the decision.",2020,"RESULTS


Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing.",['36 samples of 1 mm thickness were readied of each test material and manually polished with polishing discs (Sof-Lex) up to the finest grit size'],"['mechanical brushing', 'amine fluoride gel (Elmex gelée']","['Lava Ultimate', 'Lava Ultimate and Tetric CAD']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0080188', 'cui_str': 'Lymphocyte antigen CD15'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0169339', 'cui_str': 'amine fluoride gel'}, {'cui': 'C0059034', 'cui_str': 'Elmex'}]","[{'cui': 'C0292041', 'cui_str': 'Tetric'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]",,0.0173536,"RESULTS


Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ardu', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland, stefano.ardu@unige.ch.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Daher', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Bella', 'Affiliation': 'Department of Economics and Quantitative Methods, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Isaline', 'Initials': 'I', 'LastName': 'Rossier', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}]",American journal of dentistry,[]
2839,32464266,Efficacy and safety of conventional versus daylight photodynamic therapy in children affected by multiple facial flat warts.,"BACKGROUND


facial flat warts (FFWs) are a superficial viral skin disease, extremely common in childhood. Recently, conventional photodynamic therapy (C-PDT) has been used for the treatment of FFWs with good outcome. The efficacy of daylight photodynamic therapy (DL-PDT) has not yet been evaluated.
OBJECTIVES


to investigate and assess the efficacy and safety of C-PDT versus DL-PDT using 10% aminolevulinic acid (ALA) in the treatment of recalcitrant FFWs in a paediatric setting.
MATERIALS AND METHODS


30 consecutive patients aged <18 years with FFWs of the face were included and randomly divided into two groups: group A (15 patients) was treated with C-PDT and group B (15 patients) with DL-PDT. Patients underwent treatments for three times with 1-month intervals. The response was assessed on week 4,812 and 24 (T4,T8,T12,T24) and scored as excellent (75-100% reduction of total wart count), very good (74-50% reduction), good (49-25% reduction), poor (<25% reduction or no response). Any adverse event occurring during/after ALA application/irradiation as well as pain intensity were recorded at each visit.
RESULTS


at T4 and T8 no excellent response was achieved in both groups. At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response. Excellent outcome raised to 73.3% and 80% in group A and B, respectively, at week 24. Poor response to therapy was observed in 26.7% of patients in group A and 20% in group B. Both treatment modalities were well tolerated, with transient pain, irritation and hyperpigmentation as main side effects.
CONCLUSIONS


ALA-PDT is effective and safe for FFWs, with striking cosmetic results and no recurrence. Compared with conventional modality, DL-PDT is better tolerated, time-saving, nearly painless and greatly appreciated by young patients.",2020,"At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response.","['children affected by multiple facial flat warts', '30 consecutive patients aged <18 years with FFWs of the face']","['C-PDT versus DL-PDT using 10% aminolevulinic acid (ALA', 'conventional modality, DL-PDT', 'daylight photodynamic therapy (DL-PDT', 'conventional photodynamic therapy (C-PDT', 'DL-PDT', 'conventional versus daylight photodynamic therapy', 'C-PDT']","['tolerated, with transient pain, irritation and hyperpigmentation as main side effects', 'pain intensity', 'Efficacy and safety', 'excellent response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}]",30.0,0.0211646,"At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Borgia', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Giuffrida', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy. Electronic address: roberta_giuffrida@hotmail.it.'}, {'ForeName': 'Marialorena', 'Initials': 'M', 'LastName': 'Coppola', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Princiotta', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vaccaro', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Guarneri', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Serafinella Patrizia', 'Initials': 'SP', 'LastName': 'Cannavò', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101819']
2840,32464280,"Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: a randomized, double-blind, phase 2 trial - REACHIN.","BACKGROUND


There is a high unmet clinical need for treatments for advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy. Regorafenib has demonstrated efficacy in some gastrointestinal tumors that progress on standard therapies.
PATIENTS AND METHODS


REACHIN was a multicenter, double-blind, placebo-controlled, randomized phase 2 study designed to evaluate the safety and efficacy of regorafenib in patients with nonresectable/metastatic BTC that progressed after gemcitabine/platinum chemotherapy. Patients were randomly assigned 1:1 to best supportive care plus either regorafenib 160 mg once daily 3 weeks on/one week off or placebo until progression or unacceptable toxicity. No crossover was allowed. The primary objective was progression-free survival (PFS). Secondary objectives were response rate, overall survival (OS), and translational analysis.
RESULTS


Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9) were randomized, 33 to each treatment group. At a median follow-up of 24 months, all patients had progressed and 6 patients were alive. Median treatment duration was 11.0 weeks (95%CI: 6.0-15.9) in the regorafenib group and 6.3 weeks (95%CI: 3.9-7.0) in the placebo group (p=0.002). Fourteen of 33 patients (42%) in the regorafenib group had a dose reduction. Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002). Median PFS in the regorafenib group was 3.0 months (95%CI: 2.3-4.9) and 1.5 months (95%CI: 1.2-2.0) in the placebo group (hazard ratio 0.49; 95%CI: 0.29-0.81; p=0.004) and median OS was 5.3 months (95%CI: 2.7-10.5) and 5.1 months (95% CI: 3.0-6.4), respectively (p=0.28). There were no unexpected/new safety signals.
CONCLUSION


Regorafenib significantly improved PFS and tumor control in patients with previously treated metastatic/unresectable BTC in the second- or third-line setting.",2020,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"['advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy', 'patients with previously treated metastatic/unresectable BTC in the second- or third-line setting', 'locally advanced/metastatic biliary tumors', 'patients with nonresectable/metastatic BTC that progressed after', 'Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9']","['regorafenib', 'supportive care plus either regorafenib', 'Regorafenib', 'gemcitabine/platinum chemotherapy', 'gemcitabine and platinum-based chemotherapy', 'placebo']","['PFS and tumor control', 'Median PFS', 'median OS', 'Stable disease rates', 'Median treatment duration', 'safety and efficacy', 'progression-free survival (PFS', 'response rate, overall survival (OS), and translational analysis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005426', 'cui_str': 'Neoplasm of biliary tract'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",66.0,0.690482,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demols', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Brussels, Belgium. Electronic address: anne.demols@erasme.ulb.ac.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Eynde', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': 'Oncology Department, Saint-Joseph Community Health Center, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Oncology Department - University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marechal', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': 'GE Department, INDC Entité Jolimontoise, Haine-St-Paul, Belgium.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Goemine', 'Affiliation': 'Oncology Department, Cliniques et Maternité Ste Elisabeth, Namur, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'GE Department - Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holbrechts', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire A. Paré, Mons, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paesmans', 'Affiliation': 'Data Center, Institut J. Bordet, Brussels, Belgium.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.018']
2841,32464285,Ixazomib for treatment of refractory chronic graft vs. host disease: A Chronic GVHD Consortium phase II trial: Ixazomib for chronic GVHD treatment.,"New interventions are needed in advanced chronic GVHD. In a phase II, single-arm, multi-center trial we examined the efficacy of ixazomib in patients with chronic GVHD that had progressed after at least one prior line of systemic immune suppressive therapy. Ixazomib was given as a 4 mg oral dose weekly on days 1, 8, and 15 of a 28-day cycle for up to 6 total cycles. The primary endpoint was 6 month treatment failure, a composite endpoint including death, relapse, and requirement for an additional line of systemic immune suppressive (IS) therapy. A total of 50 subjects were enrolled at 6 institutions. Median time from chronic GVHD onset to enrollment was 2.8 years (IQR 1.5-4.3). Chronic GVHD at enrollment was NIH moderate (16%) or severe (84%), predominantly classic (80% vs. overlap 20%), with 52% having 4 or more involved organs. Patients were heavily pretreated with 39 (78%) having 3 or more prior lines of systemic therapy for chronic GVHD. Of the 50 treated subjects, 26 completed 6 months of planned therapy. The 6 month treatment failure rate was significantly lower compared with the historical benchmark (28% vs. 44%, p=0.01) previously established in second-line therapy of chronic GVHD. 16  No patient, transplant, or chronic GVHD variables were significantly associated with 6 month treatment failure. NIH-defined overall response rate was 40% at 6 months. Overall survival at 6 and 12 months was 92% and 90%. Ixazomib met the primary endpoint of low treatment failure at 6 months in the setting of advanced chronic GVHD. At 6 months the NIH CR/PR rate was 40%, and 52% remained on ixazomib suggesting the low treatment failure rate was in part due to prevention of progressive disease that would have required additional treatment.",2020,"The 6 month treatment failure rate was significantly lower compared with the historical benchmark (28% vs. 44%, p=0.01) previously established in second-line therapy of chronic GVHD.","['50 subjects were enrolled at 6 institutions', 'Patients were heavily pretreated with 39 (78%) having 3 or more prior lines of systemic therapy for chronic GVHD', '16', 'patients with chronic GVHD that had progressed after at least one prior line of systemic immune suppressive therapy']","['ixazomib', 'Ixazomib']","['NIH CR/PR rate', 'Overall survival', 'failure rate', 'Median time from chronic GVHD', 'NIH-defined overall response rate', 'Chronic GVHD', '6 month treatment failure, a composite endpoint including death, relapse, and requirement for an additional line of systemic immune suppressive (IS) therapy', 'transplant, or chronic GVHD variables']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",50.0,0.0414676,"The 6 month treatment failure rate was significantly lower compared with the historical benchmark (28% vs. 44%, p=0.01) previously established in second-line therapy of chronic GVHD.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. Electronic address: joseph.pidala@moffitt.org.'}, {'ForeName': 'Vijaya R', 'Initials': 'VR', 'LastName': 'Bhatt', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE; Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Hamilton', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Hematology/Oncology, UNC Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Onstad', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'AnneM', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Storer', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.015']
2842,32464289,Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome.,"OBJECTIVE


Comparison of the efficacy and safety of endovascular and endoscopic interventions on the gonadal vein in the treatment of patients with pelvic congestion syndrome (PCS).
MATERIALS AND METHODS


We evaluated the treatment outcomes in 95 patients with PCS who underwent endovascular embolization of gonadal veins (EEGV) (group 1, n=67) or endoscopic resection of the gonadal veins (ERGV) (group 2; n=28). A comparative analysis of the efficacy and safety of EEGV and ERGV in the treatment of PCS included assessments of their effects on the pelvic venous pain (PVP), pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity, as well as treatment safety assessment. Clinical examinations and ultrasound studies of the pelvic veins were repeated at 1, 10 and 30 days, and 36 months after EEGV and ERGV. Pain was assessed using a visual analogue scale (VAS) and the Von Korff questionnaire.
RESULTS


Pelvic venous pain. The reduction in the PVP intensity was observed at 3.6±1.4 days after EEGV and 2.5±0.8 days after ERGV (P = 0.49 between the groups). At 1 month after intervention, a complete relief of pelvic pain was reported by 52 and 25 patients in the EEGV and ERGV groups, accordingly. Status of pelvic veins. The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention. Postprocedural pain. In the early postprocedural period, pain in the femoral or jugular vein puncture site was reported by 8 (12%) patients who underwent EEGV (2.2±0.7 scores). Postembolization syndrome (PES) was diagnosed in 13 (19.4%) patients. After ERGV, all patients experienced pain in the area of the surgical wound, with a severity of 3.9±0.5 scores. Safety of interventions. Hematoma at the puncture site of the main vein was observed in 6% of patients after EEGV. Protrusion of coils was identified in 3 (4.5%) patients. The VTE incidence was 4 times greater in group 1 vs group 2 (14 vs 3 patients; P < 0.05). The relative risk (RR) of this complication after EEGV was 1.4 (95% CI 1.146 - 1.732). In 2 (7.1%) patients after the bilateral laparoscopic resection of the gonadal veins, ileus was developed. No complications of anesthesia were observed in either group.
CONCLUSION


Endovascular and endoscopic techniques for reducing blood flow through the gonadal veins are effective and safe in treating the PCS. The obvious advantages of EEGV are minimal injury and possibility to perform procedure under local anesthesia. The ERGV is associated with at least similar and, in some cases, even superior outcomes, in the terms of significantly (P < 0.05) shorter time to the postprocedural pain relief and avoiding PES.",2020,The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention.,"['pelvic congestion syndrome', 'patients with pelvic congestion syndrome (PCS', '95 patients with PCS who underwent', 'group 1, n=67) or']","['Endovascular and endoscopic techniques', 'endoscopic resection of the gonadal veins (ERGV', 'endovascular embolization of gonadal veins (EEGV', 'endovascular and endoscopic interventions', 'EEGV', 'ERGV', 'EEGV and ERGV']","['pelvic venous pain (PVP), pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity', 'complete relief of pelvic pain', 'pain in the femoral or jugular vein puncture site', 'complications of anesthesia', 'postprocedural pain relief and avoiding PES', 'PVP intensity', 'Pain', 'relative risk (RR', 'Postembolization syndrome (PES', 'pain', 'visual analogue scale (VAS) and the Von Korff questionnaire', 'blood flow', 'VTE incidence', 'Postprocedural pain', 'rates of valvular incompetence of the uterine veins', 'Protrusion of coils']","[{'cui': 'C0152078', 'cui_str': 'Pelvic congestion syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0457354', 'cui_str': 'Gonadal vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226791', 'cui_str': 'Structure of pelvic vein'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0022427', 'cui_str': 'Structure of jugular vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392008', 'cui_str': 'Complication of anesthesia'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042300', 'cui_str': 'Valvular regurgitation'}, {'cui': 'C0226787', 'cui_str': 'Structure of uterine vein'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}]",95.0,0.0344242,The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention.,"[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Gavrilov', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, 10/5 Leninsky prospect, Moscow 119049, Russia. Electronic address: gavriloffsg@mail.ru.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sazhin', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, 10/5 Leninsky prospect, Moscow 119049, Russia.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Krasavin', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, 10/5 Leninsky prospect, Moscow 119049, Russia.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Moskalenko', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, 10/5 Leninsky prospect, Moscow 119049, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Mishakina', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, 10/5 Leninsky prospect, Moscow 119049, Russia.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.05.013']
2843,31303149,Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia.,"Background:  Study retention is a major challenge in HIV clinical trials conducted with persons recruited from correctional facilities.  Objective : To examine study retention in a trial of within-prison methadone initiation and a behavioral intervention among incarcerated men with HIV and opioid dependence in Malaysia.  Methods:  In this 2x2 factorial trial, 296 incarcerated men with HIV and opioid dependence were allocated to (1) an HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care (NCT02396979). Here we estimate effects of these interventions on linkage to the study after prison release and completion of post-release study visits.  Results:  Most participants (68.9%) completed at least one post-release study visit but few (18.6%) completed all 12. HHRP-M was associated with a 13.5% (95% confidence interval (CI): 3.8%, 23.2%) increased probability of completing at least one post-release study visit. Although not associated with initial linkage, methadone treatment was associated with an 11% (95% CI: 2.0%, 20.6%) increased probability of completing all twelve post-release study visits. Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: -51.9%, -34.8%).  Conclusion:  Retaining study participants in HIV clinical trials following prison release is challenging and potentially related to the broader challenges that participants experience during community reentry. Researchers conducting clinical trials with this population may want to consider methadone and HHRP as means to improve post-release retention, even in clinical trials where these interventions are not being directly evaluated.",2019,"Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: -51.9%, -34.8%).  ","['persons recruited from correctional facilities', '296 incarcerated men with HIV and opioid dependence', 'study participants in HIV clinical trials following prison release', 'incarcerated men with HIV and opioid dependence in Malaysia', 'men with HIV and opioid dependence in Malaysia', 'participants experience during community reentry']","['HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care', 'behavioral intervention']",['HHRP-M'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442681', 'cui_str': 'Penal institution'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019844', 'cui_str': 'Wholistic Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],296.0,0.166258,"Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: -51.9%, -34.8%).  ","[{'ForeName': 'Divya K', 'Initials': 'DK', 'LastName': 'Chandra', 'Affiliation': 'a Department of Medicine , Section of Infectious Diseases, AIDS Program , Yale School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Bazazi', 'Affiliation': 'b Department of Psychiatry , University of California, San Francisco School of Medicine , San Francisco , CA , USA.'}, {'ForeName': 'Muzammil A', 'Initials': 'MA', 'LastName': 'Nahaboo Solim', 'Affiliation': 'c New Castle University Medicine , Johor , Malaysia.'}, {'ForeName': 'Adeeba', 'Initials': 'A', 'LastName': 'Kamarulzaman', 'Affiliation': 'a Department of Medicine , Section of Infectious Diseases, AIDS Program , Yale School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'a Department of Medicine , Section of Infectious Diseases, AIDS Program , Yale School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Gabriel J', 'Initials': 'GJ', 'LastName': 'Culbert', 'Affiliation': 'f Health Systems Science , Chicago College of Nursing, University of Illinois , Chicago , IL , USA.'}]",HIV research & clinical practice,['10.1080/15284336.2019.1603433']
2844,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE


Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients.
MATERIAL AND METHODS


A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end).
RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
CONCLUSIONS


This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869']
2845,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002']
2846,32464435,Comparison of parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome: A randomized clinical trial.,"OBJECTIVE


To compare the effects of parasacral transcutaneous electrical stimulation with the effects of transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome (OAB).
STUDYDESIGN


A randomized clinical trial was performed with 50 women aged 40-76 years with symptoms of OAB, divided into two groups: the parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group. Both groups underwent the same protocol, at home, for 6 weeks, applying electrical stimulation three times per week. The tools used for evaluation were the King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI). Statistical analysis was undertaken using independent t-test, Mann-Whitney test, Chi-squared test and generalized estimating equations.
RESULTS


After 6 weeks of treatment, OAB-V8 showed a significant improvement in the PTN group compared with the PS group (Mann-Whitney test, p = 0.019). Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI. All variables showed a significant effect of time after 6 weeks of treatment for both groups (p < 0.005).
CONCLUSION


Both forms of transcutaneous electrical stimulation seem to be effective and safe for home treatment of women with OAB.",2020,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","['women with overactive bladder syndrome (OAB', 'women with overactive bladder syndrome', '50 women aged 40-76 years with symptoms of OAB', 'women with OAB']","['transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation', 'transcutaneous posterior tibial nerve stimulation', 'parasacral transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group']","[""King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI"", 'KHQ domains, average KHQ symptom scale and proportions of categories of ISI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.0432647,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","[{'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Mallmann', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: suzana_mallmann@hotmail.com.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Ferla', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marina P', 'Initials': 'MP', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luciana L', 'Initials': 'LL', 'LastName': 'Paiva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Paulo R S', 'Initials': 'PRS', 'LastName': 'Sanches', 'Affiliation': 'Research and Development Service in Biomedical Engineering, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'José Geraldo L', 'Initials': 'JGL', 'LastName': 'Ramos', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.005']
2847,32464489,"Effects of transcranial direct current stimulation using miniaturized devices vs sertraline for depression in Korea: A 6 week, multicenter, randomized, double blind, active-controlled study.","We compared the efficacy and safety of transcranial direct current stimulation (tDCS) vs. Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants. This was a multi-center, double blind, active controlled study with non-inferiority testing. Patients were randomly assigned to receive tDCS (n = 45) or Sertraline (n = 47). tDCS was administered in 30-min, 2 mA prefrontal stimulation sessions for 10 consecutive weekdays, followed by 2 treatments at 4 and 6 weeks. Sertraline was administered at a dose of 50 mg per day for 6 weeks. The primary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. Mean MADRS scores decreased by 14.58 ± 8.51 points in the tDCS group and 12.32 ± 8.56 points in the Sertraline group. There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539). Noninferiority of tDCS compared with Sertraline was not demonstrated. The mean difference between the Sertraline and tDCS group was -2.258 (95% confidence interval [CI], -5.795 to 1.27811), and the lower boundary of the CI was lower than the prespecified noninferiority margin of -3.56. There were no significant group differences in the rate of adverse events. In the present study, the noninferiority of tDCS to Sertraline for the treatment of depression was not found in this Korean population.",2020,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","['depression in Korea', 'Major Depressive Disorder (MDD) in South Korean participants']","['Sertraline', 'tDCS', 'transcranial direct current stimulation (tDCS) vs. Sertraline', 'transcranial direct current stimulation using miniaturized devices vs sertraline']","['efficacy and safety', 'change in the Montgomery-Asberg Depression Rating Scale (MADRS) score', 'Mean MADRS scores', 'rate of adverse events']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.365678,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","[{'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Won-Jung', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Gangnam Yonsei Psychiatry Clinic, Seoul, South Korea; Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sejoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Borah', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Son', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Mind-neuromodulation Laboratory and Department of Psychiatry, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea. Electronic address: EMPATHY@yuhs.ac.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.012']
2848,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
2849,32464566,"Efficacy of the computer simulation-based, interactive communication education program for nursing students.","BACKGROUND


Simulation-based education using standardized patients or high fidelity patient simulators is resource-intensive and can be limited in its consistency and repeatability. Standardized, interactive, and effective computer simulation-based education programs that improve communication skills among nursing students are greatly needed.
OBJECTIVES


This study aimed to (1) compare the efficacy of a computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program on communication knowledge, learning self-efficacy, and communication efficacy at baseline and twice after the intervention (immediately after and two weeks after); and (2) assess the acceptability and satisfaction of the ComEd reported by the participants.
DESIGN


This study employed a mixed-method, randomized controlled design with repeated measures.
METHODS


Students were recruited from four nursing schools and randomly assigned to either the intervention or AC group. They received either the ComEd or AC program installed on a tablet PC or a desktop computer in the classrooms and completed a 15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale. In addition, six open-ended questions were used to help participants reflect on their learning experiences and explore their satisfaction with the programs. The Generalized Estimating Equation (GEE) model was the main model employed to examine the effects of the ComEd program over time in comparison with the AC program, and the content analysis method was used for qualitative data.
RESULTS


In total, 131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test. Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks. The ComEd program was well accepted by the participants.
CONCLUSIONS


The ComEd is a promising approach because it is highly accessible, consistent, and repeatable, and has positive learning effects.",2020,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","['131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test', 'nursing students', 'Students were recruited from four nursing schools']","['computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program', 'computer simulation-based, interactive communication education program']","['communication skills', 'communication knowledge, learning self-efficacy, and communication efficacy', 'acceptability and satisfaction', '15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}]","[{'cui': 'C0009609', 'cui_str': 'Models, Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",131.0,0.0254637,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","[{'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea; College of Nursing & The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: hchoi20@snu.ac.kr.'}, {'ForeName': 'Ujin', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dong-A University, Busan, Republic of Korea.'}]",Nurse education today,['10.1016/j.nedt.2020.104467']
2850,32464822,Impact of Residual Secondary Mitral Regurgitation on Clinical Outcomes after LVAD Implantation: An Analysis from the MOMENTUM 3 Pivotal Trial and Continuous Access Protocol Study.,"OBJECTIVES


Secondary mitral regurgitation (MR), not amenable to percutaneous or surgical repair, is common in advanced heart failure patients considered for LVAD implantation. Single center analyses have suggested variable frequency of persistent MR after LVAD implantation and consequent pulmonary hypertension, worse right heart function and more readmissions. The contemporary impact of newer devices such as the HeartMate 3 (HM3) on amelioration of MR post-LVAD implant remains uncertain. In this analysis of the MOMENTUM 3 pivotal trial and its Continued Access Protocol (CAP) study, we propose to assess the burden of significant residual MR and to evaluate the impact on clinical outcomes.
METHODS


Patients implanted with the HeartMate II (HMII) or HM3 pump in the MOMENTUM 3 pivotal trial were evaluated over 24 months to assess their relative impact on residual MR. An extended analysis of the first 500 implanted patients in CAP (HM3 only) will also be performed to validate observations from within the pivotal trial. Data on the presence and severity of MR using echocardiography were collected at baseline (pre-implant) and throughout the 24-month follow-up.
ENDPOINTS


In the pivotal trial (n=1020), 44% of patients had significant (moderate to severe) MR at baseline and 8.8% (90/1020) had undergone a prior or concomitant mitral valve procedure. In patients with no surgical mitral valve correction, overall rates of significant residual MR (irrespective of baseline MR) at each follow-up visit are shown in Figure 1. Of those patients with significant MR at baseline, 28% had persistent significant residual MR during study follow-up. In this group, HM3 patients experienced a lower frequency of significant residual MR (24%) than HMII patients (33%, p=0.05). Survival, right heart failure, and freedom from all-cause readmissions were not significantly different between patients with and without significant residual MR. Endpoints will also be validated in the CAP cohort and in patients with concomitant mitral valve correction. (Funded by Abbott).",2020,"Survival, right heart failure, and freedom from all-cause readmissions were not significantly different between patients with and without significant residual MR.","['patients with concomitant mitral valve correction', 'Patients implanted with the HeartMate II (HMII) or', 'advanced heart failure patients considered for LVAD implantation']","['HM3 pump', 'LVAD Implantation']","['severe', 'frequency of significant residual MR', 'overall rates of significant residual MR', 'MR', 'Survival, right heart failure, and freedom from all-cause readmissions', 'pulmonary hypertension, worse right heart function and more readmissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0225808', 'cui_str': 'Structure of right side of heart'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",1020.0,0.189653,"Survival, right heart failure, and freedom from all-cause readmissions were not significantly different between patients with and without significant residual MR.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kanwar', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rajagopal', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, TX.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Silvestry', 'Affiliation': 'Advent Health Transplant Institute, Orlando, FL.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Salerno', 'Affiliation': 'St. Vincent Heart Center, Indianapolis, IN.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Horstmanshof', 'Affiliation': 'INTEGRIS Baptist Medical Center, Oklahoma City, OK.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Montefiore Einstein Center for Heart and Vascular Care, New York, NY.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Gregoric', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, TX.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chuang', 'Affiliation': 'Abbott, Abbott Park, IL.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott, Abbott Park, IL.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.992']
2851,32464827,Questionable Value of Concomitant Tricuspid Valve Procedure with Left Ventricular Assist Device Implantation.,"PURPOSE


Tricuspid regurgitation (TR) is common in end stage heart failure patients receiving left ventricular assist devices (LVADs), but the value of intervention is uncertain. This study examined the impact of tricuspid valve procedures (TVP) at time of LVAD implantation on clinical outcomes and quality of life metrics.
METHODS


We included patients in the INTERMACS database with TR who received continuous-flow LVADs from the 2008 to 2017. TR was stratified by severity. Patients receiving concomitant TVP were compared to those without intervention in a stratified analysis. Survival analyses and Andersen-Gill hazard models were used to examine associations with clinical outcomes.
RESULTS


Our analysis included 8263 (53.1%) mild, 4252 (33.3%) moderate, and 2100 (13.5%) severe TR cases. TVP rate increased with severity: 13.0% of mild cases underwent TVP versus 55.2% of severe cases. TVP was not associated with survival difference for mild (median 57.8 months for TVP vs. 55.6 months for non-TVP, P=0.69, HR 1.10 [95%: 0.87-1.50]), moderate (47.5 vs. 51.1 months, P=0.23, HR 1.20 [0.99-1.50]), or severe TR (43.3 vs 46.3 months, P=0.09, HR 1.30 [0.99-1.60]). TVP was associated with increased risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P<0.01 for each) and not with Kansas City Cardiomyopathy Questionnaire (KCCQ) differences at 12- or 24-months follow-up.
CONCLUSION


TVP at time of LVAD implantation was not associated with differences in survival or KCCQ scores. However, there were associations with increased risk of adverse events. Further studies are needed to understand appropriateness criteria for TVP with LVAD implantation.",2020,"TVP was associated with increased risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P<0.01 for each) and not with Kansas City Cardiomyopathy Questionnaire (KCCQ) differences at 12- or 24-months follow-up.
","['stage heart failure patients receiving left ventricular assist devices (LVADs', 'patients in the INTERMACS database with TR who received continuous-flow LVADs from the 2008 to 2017']","['Concomitant Tricuspid Valve Procedure with Left Ventricular Assist Device Implantation', 'concomitant TVP', 'TVP', 'LVAD implantation', 'tricuspid valve procedures (TVP']","['survival difference for mild', 'risk of adverse events', 'clinical outcomes and quality of life metrics', 'TVP rate', 'survival or KCCQ scores', 'risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P<0.01 for each) and not with Kansas City Cardiomyopathy Questionnaire (KCCQ) differences']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]",,0.0402404,"TVP was associated with increased risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P<0.01 for each) and not with Kansas City Cardiomyopathy Questionnaire (KCCQ) differences at 12- or 24-months follow-up.
","[{'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Mullan', 'Affiliation': 'Department of Surgery, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Caraballo', 'Affiliation': 'Center for Outcomes Research & Evaluation, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Ravindra', 'Affiliation': 'Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Section of Cardiovascular Medicine, Yale National Clinician Scholars Program, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McCullough', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Clarke', 'Affiliation': 'Department of Internal Medicine (Bridgeport Hospital), Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Geirsson', 'Affiliation': 'Department of Surgery, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Desai', 'Affiliation': 'Center for Outcomes Research & Evaluation and Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Center for Outcomes Research & Evaluation and Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.997']
2852,32464832,"A European Multi-Center, Randomized, Double-Blind Trial of Pirfenidone in Bronchiolitis-Obliterans-Syndrome Grade 1-3 in Lung Transplant Recipients (European Trial of Pirfenidone in BOS (EPOS)).","OF OBJECTIVES


Bronchiolitis obliterans syndrome (BOS), the most common form of chronic lung allograft dysfunction (CLAD), and the major limitation to long-term survival after lung transplantation. BOS affects up to 50% of lung transplant recipients within 5 years after transplant, causing significant morbidity and mortality. BOS manifesting early after transplantation shows a poorer prognosis than late-onset BOS. There are only few studies assessing treatment efficacy, but only a minority of patients respond to current treatment options. From trans-bronchial surveillance biopsies and autopsies from diseased transplant recipients, the BOS lesions reveal interstitial fibrosis, which suggest the possible use of anti-fibrotic agent like Pirfenidone. We hypothesized that there is a statistically significant difference between randomized study groups in the change in FEV1 from baseline to 6 months.
METHODS


This trial is investigator-initiated and including nine European expert lung transplant centers. Patients with new onset progressive BOS were randomized in a 1:1 ratio to receive either Pirfenidone or the matching placebo treatment for 6 months. Progressive BOS was defined by the following: at least 3 FEV1-measurements in the last 6 months, each at least 3 weeks apart, a total decline of at least 200ml in FEV1, and a mean decline of at least 50 ml in the last two measurements, as well as the exclusion of other reasons for FEV1 decline by an expert panel. All patients had to be on at least 250mg Azithromycin 3 times a week for at least 4 weeks prior to inclusion. A total of 80 patients were planned included in the study 40 in each group.
ENDPOINTS


The primary endpoint is to evaluate the effect of Pirfenidone on the change in FEV1 (ml) over 6 months in lung transplant recipients with BOS, who are treated with Azithromycin. Secondary endpoints are as follows; Categorical percentage change in FEV1, Change in FVC, Change in TLC, Change in FEV1/FVC ratio, Number of patients with treatment failure, Change in BOS grade, Change in percent predicted diffusion capacity (DLco), Change in functional level as assessed by 6MWT, Hospital admission for any reason, Death or re-transplantation rates, Change in quality of life assessed by EQ5D.",2020,Patients with new onset progressive BOS were randomized in a 1:1 ratio to receive either Pirfenidone or the matching placebo treatment for 6 months.,"['80 patients were planned included in the study 40 in each group', 'Bronchiolitis obliterans syndrome (BOS', 'Patients with new onset progressive BOS', 'lung transplant recipients with BOS, who are treated with', 'nine European expert lung transplant centers', 'Bronchiolitis-Obliterans-Syndrome Grade 1-3 in Lung Transplant Recipients (European Trial of Pirfenidone in BOS (EPOS']","['Azithromycin', 'Pirfenidone', 'Pirfenidone or the matching placebo']","['follows; Categorical percentage change in FEV1, Change in FVC, Change in TLC, Change in FEV1/FVC ratio, Number of patients with treatment failure, Change in BOS grade, Change in percent predicted diffusion capacity (DLco), Change in functional level as assessed by 6MWT, Hospital admission for any reason, Death or re-transplantation rates, Change in quality of life assessed by EQ5D', 'BOS', 'Progressive BOS', 'change in FEV1 (ml', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006272', 'cui_str': 'Obliterative bronchiolitis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0006272', 'cui_str': 'Obliterative bronchiolitis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",80.0,0.18226,Patients with new onset progressive BOS were randomized in a 1:1 ratio to receive either Pirfenidone or the matching placebo treatment for 6 months.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perch', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Besa', 'Affiliation': 'Ruhrlandklinik, West German Lung Transplantation Center, University Hospital, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Corris', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Iversen', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kneidinger', 'Affiliation': 'Uniklinik Grosshadern, Munich, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Leuckfeld', 'Affiliation': 'Oslo Univ Hospital, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lordan', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Magnusson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Verleden', 'Affiliation': 'Univ Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Verschuuren', 'Affiliation': 'University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Univ Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gottlieb', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1130']
2853,32464870,The Effect of Renin-Angiotensin-Aldosterone System Inhibition on Morbidity and Mortality during Long-Term Continuous-Flow Left Ventricular Assist Device Support.,"PURPOSE


Inhibition of the renin angiotensin-aldosterone system (RAAS) improves survival and reduces adverse cardiac events in heart failure with reduced ejection fraction, but the benefit is not well-defined following left ventricular assist device (LVAD).
METHODS


We analyzed the ISHLT IMACS registry for adults with a primary, continuous-flow LVAD from January 2013 to September 2017 who were alive at post-operative month 3 without a major adverse event, and categorized patients according to treatment at month 3 with an angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), mineralocorticoid receptor antagonist (MRA), or neither (noRAAS).
RESULTS


Of 11,494 patients included, 50% were treated with ACEI/ARB and 38% with MRA. Propensity score matching was performed separately for ACEI/ARB versus noRAAS (n=2,853 each) and MRA versus noRAAS (n=2,670 each). Kaplan-Meier survival was significantly better for patients receiving ACEI/ARB (Figure A, p<0.001) and MRA (Figure B, p=0.03). In Cox proportional hazards analyses adjusted for known predictors of survival following LVAD, ACEI/ARB use (HR 0.79 [95% CI 0.69-0.90], p<0.001) but not MRA use (HR 0.94 [95% CI 1.02-1.49], p=0.33) was independently associated with better survival. Among patients treated with an ACEI/ARB, there was a non-significant trend toward less gastrointestinal bleeding (p=0.08) but significantly more hemolysis (p=0.04) at 12 months. Rates of late right heart failure (p=0.41), stroke (p=0.40), dialysis (p=0.29), and NYHA class (p=0.44) at 12 months were similar. Potential limitations include residual confounding and therapy crossover.
CONCLUSION


These findings suggest a benefit for ACEI/ARB as tolerated in patients with heart failure after LVAD implantation.",2020,"Rates of late right heart failure (p=0.41), stroke (p=0.40), dialysis (p=0.29), and NYHA class (p=0.44) at 12 months were similar.","['heart failure with reduced ejection fraction', 'adults with a primary, continuous-flow LVAD from January 2013 to September 2017 who were alive at post-operative month 3 without a major adverse event, and categorized patients according to treatment at month 3 with an', 'patients with heart failure after LVAD implantation', 'MRA), or neither (noRAAS']","['Renin-Angiotensin-Aldosterone System Inhibition', 'renin angiotensin-aldosterone system (RAAS', 'angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), mineralocorticoid receptor antagonist', 'ACEI/ARB']","['Rates of late right heart failure', 'Kaplan-Meier survival', 'survival', 'stroke (p=0.40), dialysis', 'Morbidity and Mortality', 'gastrointestinal bleeding']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",11494.0,0.181444,"Rates of late right heart failure (p=0.41), stroke (p=0.40), dialysis (p=0.29), and NYHA class (p=0.44) at 12 months were similar.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Brinkley', 'Affiliation': 'Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kiernan', 'Affiliation': 'Medicine, Tufts Medical Center, Boston, MA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1034']
2854,32470531,The high-risk ECG pattern of ST-elevation myocardial infarction: A substudy of the randomized trial of primary PCI with or without routine manual thrombectomy (TOTAL trial).,"BACKGROUND


Useful tools for risk assessment in patients with STEMI are needed. We evaluated the prognostic impact of the evolving myocardial infarction (EMI) and the preinfarction syndrome (PIS) ECG patterns and determined their correlation with angiographic findings and treatment strategy.
METHODS


This substudy of the randomized Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern. The primary outcome was a composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year.
RESULTS


The primary outcome occurred in 271 of 2618 patients (10.4%) in the EMI group vs. 322 of 5242 patients (6.1%) in the PIS group [AdjustedHR, 1.54; 95% CI, 1.30 to 1.82; p < .001]. The primary outcome occurred in the thrombectomy and PCI alone groups in 131 of 1306 (10.0%) and 140 of 1312 (10.7%) patients with EMI [HR 0.94; 95% CI, 0.74-1.19] and 162 of 2633 (6.2%) and 160 of 2609 (6.1%) patients with PIS [HR 1.00; 95% CI, 0.81-1.25], respectively (p interaction  = 0.679).
CONCLUSIONS


Patients with the EMI ECG pattern proved to have an increased rate of the primary outcome within one year compared to the PIS pattern. Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns. The PIS/EMI dynamic ECG classification could help to triage patients in case of simultaneous STEMI patients with immediate need for pPCI.",2020,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"['ST-elevation myocardial infarction', 'patients with STEMI', 'Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern']","['PCI versus PCI Alone', 'primary PCI with or without routine manual thrombectomy']","['composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0086666', 'cui_str': 'Preinfarction syndrome'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",7860.0,0.0957483,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"[{'ForeName': 'Joonas', 'Initials': 'J', 'LastName': 'Leivo', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland. Electronic address: joonas.leivo@fimnet.fi.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Anttonen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.'}, {'ForeName': 'Jyri', 'Initials': 'J', 'LastName': 'Koivumäki', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Tahvanainen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Koivula', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland; Internal medicine, Helsinki University Hospital, Finland.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Nikus', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Niemelä', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Eskola', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.053']
2855,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max  of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞  ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qimingwang1006@126.com.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.. Electronic address: hengjianfu106@163.com.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384']
2856,32470635,Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial.,"Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI). Current ablative technologies that modify calcium to optimize stent deployment are limited by guidewire bias and periprocedural complications related to atheroembolization, coronary dissection, and perforation. Intravascular lithotripsy (IVL) delivers pulsatile ultrasonic pressure waves through a fluid-filled balloon into the vessel wall to modify calcium and enhance vessel compliance, reduce fibroelastic recoil, and decrease the need for high-pressure balloon (barotrauma) inflations. IVL has been used in peripheral arteries as stand-alone revascularization or as an adjunct to optimize stent deployment. STUDY DESIGN AND OBJECTIVES: Disrupt CAD III (clinicaltrials.gov identifier: NCT03595176) is a prospective, multicenter, single-arm study designed to assess safety and efficacy of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with de novo calcified coronary stenoses. The primary safety end point is freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization) at 30 days compared to a prespecified performance goal. The primary effectiveness end point is procedural success without in-hospital major adverse cardiovascular events. Enrollment will complete early in 2020 with clinical follow-up ongoing for 2 years. CONCLUSION: Disrupt CAD III will evaluate the safety and effectiveness of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with calcified coronary stenoses.",2020,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"['severely calcified coronary stenoses', 'patients with de novo calcified coronary stenoses', 'patients with calcified coronary stenoses']","['coronary intravascular lithotripsy', 'Intravascular lithotripsy (IVL', 'Shockwave coronary IVL catheter', 'percutaneous coronary intervention (PCI']","['procedural success without in-hospital major adverse cardiovascular events', 'safety and efficacy', 'freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0335608,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital and Lindner Research Center, Cincinnati, OH. Electronic address: Lindner@thechristhospital.com.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hill', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Beaux', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'Shockwave Medical, Santa Clara, CA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.04.005']
2857,32470923,"No Differences Between Beetroot Juice and Placebo on Competitive 5-km Running Performance: A Double-Blind, Placebo-Controlled Trial.","The authors examine the effect of an acute dose of beetroot juice on endurance running performance in ""real-world"" competitive settings. In total, 70 recreational runners (mean ± SD: age = 33.3 ± 12.3 years, training history = 11.9 ± 8.1 years, and hours per week training = 5.9 ± 3.5) completed a quasi-randomized, double-blind, placebo-controlled study of 5-km competitive time trials. Participants performed four trials separated by 1 week in the order of prebaseline, two experimental, and one postbaseline. Experimental trials consisted of the administration of 70-ml nitrate-rich beetroot juice (containing ∼4.1 mmol of nitrate, Beet It Sport®) or nitrate-depleted placebo (containing ∼0.04 mmol of nitrate, Beet It Sport®) 2.5 hr prior to time trials. Time to complete 5 km was recorded for each trial. No differences were shown between pre- and postbaseline (p = .128, coefficient variation = 2.66%). The average of these two trials is therefore used as baseline. Compared with baseline, participants ran faster with beetroot juice (mean differences = 22.2 ± 5.0 s, p < .001, d = 0.08) and placebo (22.9 ± 4.5 s, p < .001, d = 0.09). No differences in times were shown between beetroot juice and placebo (0.8 ± 5.7 s, p < .875, d = 0.00). These results indicate that an acute dose of beetroot juice does not improve competitive 5-km time-trial performance in recreational runners compared with placebo.",2020,"Compared with baseline, participants ran faster with beetroot juice (mean differences = 22.2 ± 5.0 s, p < .001, d = 0.08) and placebo (22.9 ± 4.5 s, p < .001, d = 0.09).","['real-world"" competitive settings', 'recreational runners', '70 recreational runners (mean ± SD: age = 33.3 ± 12.3\xa0years, training history = 11.9 ± 8.1\xa0years, and hours per week training = 5.9 ± 3.5']","['Placebo', '70-ml nitrate-rich beetroot juice (containing ∼4.1\xa0mmol of nitrate, Beet It Sport®) or nitrate-depleted placebo (containing ∼0.04\xa0mmol of nitrate, Beet It Sport®', 'Beetroot Juice and Placebo', 'beetroot juice', 'placebo']","['endurance running performance', 'competitive 5-km time-trial performance', 'Competitive 5-km Running Performance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",70.0,0.503505,"Compared with baseline, participants ran faster with beetroot juice (mean differences = 22.2 ± 5.0 s, p < .001, d = 0.08) and placebo (22.9 ± 4.5 s, p < .001, d = 0.09).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hurst', 'Affiliation': 'Canterbury Christ Church University.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Saunders', 'Affiliation': 'Defence Science and Technology Laboratory (DSTL).'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Coleman', 'Affiliation': 'Canterbury Christ Church University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0034']
2858,32470924,No Effect of New Zealand Blackcurrant Extract on Recovery of Muscle Damage Following Running a Half-Marathon.,"New Zealand blackcurrant (NZBC) contains anthocyanins, known to moderate blood flow and display anti-inflammatory properties that may improve recovery from exercise-induced muscle damage. The authors examined whether NZBC extract supplementation enhances recovery from exercise-induced muscle damage after a half-marathon race. Following a randomized, double-blind, independent groups design, 20 (eight women) recreational runners (age 30 ± 6 years, height 1.73 ± 0.74 m, body mass 68.5 ± 7.8 kg, half-marathon finishing time 1:56:33 ± 0:18:08 hr:min:s) ingested either two 300-mg/day capsules of NZBC extract (CurraNZ™) or a visually matched placebo, for 7 days prior to and 2 days following a half-marathon. Countermovement jump performance variables, urine interleukin-6, and perceived muscle soreness and fatigue were measured pre, post, and at 24 and 48 hr after the half-marathon and analyzed using a mixed linear model with statistical significance set a priori at p < .05. The countermovement jump performance variables were reduced immediately post-half-marathon (p < .05), with all returning to pre-half-marathon levels by 48 hr, except the concentric and eccentric peak force and eccentric duration, with no difference in response between groups (p > .05). Urine interleukin-6 increased 48-hr post-half-marathon in the NZBC group only (p < .01) and remained unchanged compared with pre-half-marathon levels in the placebo group (p > .05). Perceived muscle soreness and fatigue increased immediately post-half-marathon (p < .01) and returned to pre-half-marathon levels by 48 hr, with no difference between groups (p > .05). Supplementation with NZBC extract had no effect on the recovery of countermovement jump variables and perceptions of muscle soreness or fatigue following a half-marathon in recreational runners.",2020,Supplementation with NZBC extract had no effect on the recovery of countermovement jump variables and perceptions of muscle soreness or fatigue following a half-marathon in recreational runners.,"['recreational runners', '20 (eight women) recreational runners (age 30 ± 6 years, height 1.73 ± 0.74\xa0m, body mass 68.5 ± 7.8\xa0kg, half-marathon finishing time 1:56:33 ± 0:18:08']","['NZBC extract supplementation', 'New Zealand Blackcurrant Extract', 'NZBC extract (CurraNZ™) or a visually matched placebo', 'NZBC extract', 'placebo']","['Perceived muscle soreness and fatigue', 'Urine interleukin-6', 'concentric and eccentric peak force and eccentric duration', 'Countermovement jump performance variables, urine interleukin-6, and perceived muscle soreness and fatigue', 'countermovement jump performance variables', 'Recovery of Muscle', 'recovery of countermovement jump variables and perceptions of muscle soreness or fatigue']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517478', 'cui_str': '0.74'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.301112,Supplementation with NZBC extract had no effect on the recovery of countermovement jump variables and perceptions of muscle soreness or fatigue following a half-marathon in recreational runners.,"[{'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Costello', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Myers', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Myers', 'Affiliation': 'University of Portsmouth.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Lewis', 'Affiliation': 'English Institute of Sport.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'University of Chichester.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'University of Chichester.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2019-0312']
2859,32470942,Prediction of clinical height gain from surgical posterior correction of idiopathic scoliosis.,"OBJECTIVE


The best predictors of height gain due to surgical correction are the number of fused vertebrae and the degrees of the corrected Cobb angle. Existing studies of predictive models measured the radiographic spinal height and did not report the clinical height gain. The aims of this study were to determine the best predictive factors of clinical height gain before surgical correction, construct a predictive model using patient population data for machine learning, and test the performance of this model on a validation population.
METHODS


The authors reviewed 145 medical records of consecutive patients who underwent surgery that included placement of posterior spinal instrumentation and fusion for idiopathic scoliosis between 2012 and 2016. Standing and sitting clinical heights were measured before and after surgery in patients who had been surgically treated under similar conditions. Multivariate analysis was then performed and the results were used to develop a predictive model for height gain after surgery. The data from the included patients were randomly assigned to a learning set or a test set.
RESULTS


In total, 116 patients were included in the analysis, for whom the average postoperative clinical height gain in a standing position was 4.2 ± 1.8 cm (range 0-11 cm). The best prediction model was calculated as follows: standing clinical height gain (cm) = 1 - 0.023 × sitting clinical height (cm) - 0.19 × Risser stage + 0.058 × Cobb preoperative angle (°) + 0.021 × T5-12 kyphosis (°) + 0.14 × number of levels fused. In the validation cohort, 91% of the predicted values had an error of less than one-half of the actual height gain.
CONCLUSIONS


This predictive model formula for calculating the potential postoperative height gain after surgical treatment can be used preoperatively to inform idiopathic scoliosis patients of what outcomes they may expect from posterior spinal instrumentation and fusion (taking into account the model's uncertainty).",2020,The best prediction model was calculated as follows: standing clinical height gain (cm) = 1 - 0.023 × sitting clinical height (cm) - 0.19 × Risser stage + 0.058 × Cobb preoperative angle (°) + 0.021 × T5-12 kyphosis (°) + 0.14 × number of levels fused.,"['145 medical records of consecutive patients who underwent surgery that included placement of posterior spinal instrumentation and fusion for idiopathic scoliosis between 2012 and 2016', 'patients who had been surgically treated under similar conditions', '116 patients were included in the analysis, for whom the average postoperative clinical height gain in a standing position was 4.2 ± 1.8 cm (range 0-11 cm', 'idiopathic scoliosis patients', 'idiopathic scoliosis']",[],"['Standing and sitting clinical heights', 'radiographic spinal height', 'standing clinical height gain']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0589058', 'cui_str': 'Posterior spinal instrumentation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",116.0,0.0524115,The best prediction model was calculated as follows: standing clinical height gain (cm) = 1 - 0.023 × sitting clinical height (cm) - 0.19 × Risser stage + 0.058 × Cobb preoperative angle (°) + 0.021 × T5-12 kyphosis (°) + 0.14 × number of levels fused.,"[{'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Langlais', 'Affiliation': '1Pediatric Orthopaedics Department, Institut Calot, Berck-sur-Mer.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Verdun', 'Affiliation': '3Biostatistics Department-Delegations for Clinical Research and Innovation, Lille Catholic Hospitals, Lille.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Compagnon', 'Affiliation': ""4Pediatric Orthopaedics Department, Children's Hospital Purpan, Toulouse; and.""}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Ursu', 'Affiliation': '1Pediatric Orthopaedics Department, Institut Calot, Berck-sur-Mer.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vergari', 'Affiliation': '2Institut de Biomécanique Humaine Georges Charpak, Arts et Metiers ParisTech, Laboratoire de Biomécanique, Paris.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Barret', 'Affiliation': '5Orthopedic Department, Cannes Hospital, Cannes, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Morin', 'Affiliation': '1Pediatric Orthopaedics Department, Institut Calot, Berck-sur-Mer.'}]",Journal of neurosurgery. Spine,['10.3171/2020.3.SPINE191541']
2860,32470975,Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years.,"BACKGROUND


Deficiency of vitamin B-12 is common in pregnant Indian women. Assessment of neurophysiological measures using event-related potentials (ERPs) may yield additional information on the effects of maternal B-12 supplementation on child brain function.
OBJECTIVES


The objective of the study was to evaluate the effects of vitamin B-12 supplementation (50 μg daily orally) during pregnancy on the childhood ERP measures of positive waveform ∼300 ms after stimulus (P300) and mismatch negativity.
METHODS


This study was a follow-up of children born to pregnant women who received oral vitamin B-12 supplements (n = 62) compared with children of pregnant women who received placebo (n = 70) from a randomized controlled trial. The mean ± SD child age was 72 ± 1 mo. We used the Enobio system to assess the ERP measures P300 and mismatch negativity.
RESULTS


There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups. We combined the intervention and placebo groups for secondary analyses. On multiple variable regression analysis after adjusting for treatment group, intrauterine growth restriction, and home environment, P300 amplitude in children was significantly higher in the lowest tertile of third-trimester maternal methylmalonic acid (MMA) concentrations (β = 3034.04; 95% CI: 923.24, 5144.83) compared with the highest MMA tertile (β = 1612.12; 95% CI: -258.86, 3483.10, P = 0.005).
CONCLUSIONS


While no significant effects of maternal vitamin B-12 supplementation on children's ERP measures were seen at 72 mo, elevated maternal MMA concentrations in the third trimester were negatively associated with P300 amplitude in children. It may be worthwhile to study the impact of maternal and infant vitamin B-12 supplementation on childhood brain structure and function in longer and larger trials. The parent trial was registered at clinicaltrials.gov as NCT00641862.",2020,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","['children born to pregnant women who received', 'n\xa0=\xa062) compared with children of pregnant women who received', 'during Pregnancy and Early Lactation', 'Children', 'Aged 6 Years', 'pregnant Indian women']","['event-related potentials (ERPs', 'vitamin B-12 supplementation', 'oral vitamin B-12 supplements', 'maternal vitamin B-12 supplementation', 'Vitamin B-12 Supplementation', 'placebo']","['childhood ERP measures of positive waveform ∼300\xa0ms after stimulus (P300) and mismatch negativity', 'amplitudes, and latencies of the P300 results and the mismatch negativity', ""children's ERP measures"", 'ERP measures P300 and mismatch negativity', 'maternal MMA concentrations', 'Neurophysiologic Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.385632,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayachandra', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tor Arne', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hosptial Trust, Lillehammer, Norway.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa123']
2861,32464807,The NOVEL Study. A Multi-Center Clinical Trial Studying the Safety of Ex Vivo Lung Perfusion.,"PURPOSE


lung transplantation continues to be a life saving therapy for patients with end stage lung disease. In a donor restrictive environment and with only 22% of donor lungs currently being transplanted ex vivo lung perfusion can increase donor use and transplantation preserving safety and good outcomes METHODS: the NOVEL study is a prospective, multi-center, controlled clinical trial. Seventeen US lung transplant centers evaluated the safety of screening donors initially considered unacceptable for transplant with normothermic ex vivo lung perfusion (EVLP).
RESULTS


from 2011 to 2017 seventeen lung transplant centers evaluated 216 donors with EVLP. 110 were transplanted for a 50.9% conversion rate. Early and long-term outcomes were compared to 116 control patients that underwent transplantation using standard criteria lungs. The primary endpoints for this study were Primary Graft Dysfunction (PGD) grade 3 at 72 hours and 1-year survival. The rate of PGD grade 3 at 72 hrs. was non-inferior between the ELVP and Control group (8.9% vs 9.5%, p 0.12). The 1-year survival for the EVLP group was 93.2% vs. 96.5% for the Control group, p 0.84. Secondary endpoints such as ICU length of stay, 9.9 vs 9.8 days, hospital length of stay, 23.9 vs 28.5 days, duration of mechanical ventilation, 7.0 vs 5.7 days, were also not significantly different between the EVLP and Control groups. Median FEV 1 was also no different between the EVLP and Control groups 12 months post transplant 65 vs 70 %.
CONCLUSION


data from this multi-center, controlled clinical trial demonstrates that the use of ex vivo lung perfusion to screen for viable grafts within the unused donor pool is safe and provides equal short and long therm outcomes to standard criteria donor lungs.",2020,"The rate of PGD grade 3 at 72 hrs. was non-inferior between the ELVP and Control group (8.9% vs 9.5%, p 0.12).","['patients with end stage lung disease', 'Seventeen US lung transplant centers', '2017 seventeen lung transplant centers evaluated 216 donors with EVLP', '116 control patients that underwent transplantation using standard criteria lungs']",['EVLP'],"['Primary Graft Dysfunction (PGD) grade 3 at 72 hours and 1-year survival', 'Median FEV', 'duration of mechanical ventilation', 'ICU length of stay, 9.9 vs 9.8 days, hospital length of stay', 'rate of PGD grade', '1-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324356', 'cui_str': 'End stage lung disease'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0481485,"The rate of PGD grade 3 at 72 hrs. was non-inferior between the ELVP and Control group (8.9% vs 9.5%, p 0.12).","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Sanchez', 'Affiliation': 'Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cantu', 'Affiliation': 'Cardiothoracic Surgery, University Pennsylavania, Pittsburgh, PA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hartwig', 'Affiliation': 'Cardiothoracic Surgery, Duke Unniversity, Durham, NC.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': ""D'Ovidio"", 'Affiliation': 'Cardiothoracic Surgery, Columbia University, New York, NY.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Machuca', 'Affiliation': 'Cardiothoracic Surgery, University of Florida, Gainsville, FL.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Whitson', 'Affiliation': 'Cardiothoracic Surgery, Ohio State University, Columbus, OH.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Daneshmand', 'Affiliation': 'Cardiothoracic Surgery, Emory University, Atlanta, GA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bermudez', 'Affiliation': 'Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mulligan', 'Affiliation': 'Cardiothoracic Surgery, University of Washington, Seattle, WA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""D'Cunha"", 'Affiliation': 'Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weyant', 'Affiliation': 'Cardiothoracic Surgery, University of Colorado, Denver, CO.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lynch', 'Affiliation': 'Cardiothoracic Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Cardiothoracic Surgery, Indiana University, Indianapolis, IN.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Caldeira', 'Affiliation': 'Cardiothoracic Surgery, University of South Florida, Tampa, FL.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nemeh', 'Affiliation': 'Cardiothoracic Surgery, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Cardiothoracic Surgery, University of Chicago, Chicago, IL.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kreisel', 'Affiliation': 'Cardiothoracic Surgery, Washington University, Saint Louis, MO.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jessen', 'Affiliation': 'Cardiothoracic Surgery, University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Camp', 'Affiliation': 'Cardiothoracic Surgery, Spectrum Health, Grand Rapids, MI.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ramzy', 'Affiliation': 'Cardiothoracic Surgery, Cedars Sinai Medical Center, Loas Angeles, CA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Griffith', 'Affiliation': 'Cardiothoracic Surgery, University of Maryland, Baltimore, MD.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'Cardiothoracic Surgery, Florida Hospital, Orlando, FL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.977']
2862,32464878,Non-Ischemic Heart Preservation versus Static Cold Storage in Human Heart Transplantation.,"PURPOSE


Pre-clinical studies have shown that ex vivo non-ischemic heart preservation (NIHP) method can be safely used for 24 hours. This state-of-the-art method has never been applied on humans. ໿໿The primary objective of the study was to evaluate the efficacy and safety of the NIHP method on early and late human heart allograft function compared with static cold storage (SCS).
METHODS


We performed a prospective, open-label, non-randomised phase II study. All adult recipients listed for heart transplantation were included, unless they met any exclusion criteria. The primary endpoint was a composite of survival free of severe primary graft dysfunction, free of ECMO use within 7 days, and free of acute cellular rejection ≥2R within 180 days. Secondary endpoints were I/R-tissue injury, immediate graft function, and adverse event. Of the 37 eligible patients, nine were assigned to the NIHP method and 28 to SCS.
RESULTS


The median age was 51 years (interquartile range (IQR), 37-58) for the donors and 56 years (IQR, 46 - 63) for the recipients. The median preservation time was significant longer for the NIHP group, 251 min (IQR, 219-269) compared with the SCS group, 199 min (IQR, 164 - 227), P=0.008. Over the first three months, all of the patients assigned to the NIHP group achieved event-free survival, compared with 21 (75%) of those assigned to the SCS group (Kaplan-Meier estimate of event free survival 75% (95% CI 55-87%); P=0.124). CK-MB assessed 6±2 h after ending perfusion was 77 (IQR, 54-101) ng/mL for the NIHP group compared with 137 (IQR, 73-196) ng/mL for the SCS group, P=0.030. Four (16%) death within six months after transplantation and three (12%) cardiac-related adverse events were reported in the SCS group compared with no deaths or cardiac-related adverse events in the NIHP group.
CONCLUSION


This first-in-human study shows the NIHP method's feasibility and safety for use in the clinic of heart transplantation.",2020,"The median preservation time was significant longer for the NIHP group, 251 min (IQR, 219-269) compared with the SCS group, 199 min (IQR, 164 - 227), P=0.008.","['The median age was 51 years (interquartile range (IQR), 37-58) for the donors and 56 years (IQR, 46 - 63) for the recipients', 'Human Heart Transplantation', 'All adult recipients listed for heart transplantation were included, unless they met any exclusion criteria', '37 eligible patients, nine were assigned to the NIHP method and 28 to SCS']","['NIHP', 'Static Cold Storage', 'static cold storage (SCS', 'SCS']","['cardiac-related adverse events', 'efficacy and safety', 'median preservation time', 'composite of survival free of severe primary graft dysfunction, free of ECMO use within 7 days, and free of acute cellular rejection ≥2R', 'event-free survival', 'I/R-tissue injury, immediate graft function, and adverse event']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C4552279', 'cui_str': 'Tissue injury'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",37.0,0.0603537,"The median preservation time was significant longer for the NIHP group, 251 min (IQR, 219-269) compared with the SCS group, 199 min (IQR, 164 - 227), P=0.008.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jernryd', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paskevicius', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Metzsch', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Medved', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sjöberg', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Steen', 'Affiliation': 'Clinical Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes University Hospital, Lund, Sweden.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1043']
2863,32464903,"Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients (IronIC) - A Randomized, Double Blind, Controlled Trial.","OF OBJECTIVES


Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) iron therapy will improve exercise capacity assessed by peak oxygen consumption.
METHODS


102 stable, cardiac transplant recipients with ID, defined as serum ferritin <100 µg/l, or ferritin between 100 and 300 µg/l in combination with transferrin saturation <20 %, have been randomized in a 1:1 manner to treatment with intravenous iron isomaltoside, 20 mg/kg, or NaCl. Care was taken to blind patients and personnel to the color of the infusate. All participants provided written, informed consent. Exclusion criteria included hemoglobin <100 g/l, red blood cell disorders, end-stage kidney failure, intolerance to iron isomaltoside, and ongoing infections or rejections. Prior to the intervention, all patients underwent a treadmill test to measure peak oxygen consumption. Muscle strength by a hand grip test, cognitive function, and self-reported quality of life were also measured. All tests are repeated at follow-up 6 months after intervention. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Last patient is scheduled for follow-up February 2020.
ENDPOINTS


The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of iron isomaltoside. Secondary objectives are to assess the impact of treatment on iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous iron supplement. Results will be ready for presentation at the 2020 ISHLT conference.",2020,The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption.,"['heart transplant recipients with ID', 'Cardiac Transplant Recipients (IronIC', 'Heart transplant recipients', 'Exclusion criteria included hemoglobin <100 g/l, red blood cell disorders, end-stage kidney failure, intolerance to iron isomaltoside, and ongoing infections or rejections', '102 stable, cardiac transplant recipients with ID, defined as serum ferritin <100 µg/l, or ferritin between 100 and 300 µg/l in combination with transferrin saturation <20 ']","['intravenous iron isomaltoside, 20 mg/kg, or NaCl', 'Intravenous Iron Supplement']","['peak oxygen consumption', 'iron stores, muscle strength, cognitive function, quality of life, safety and tolerability', 'Muscle strength by a hand grip test, cognitive function, and self-reported quality of life']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0221016', 'cui_str': 'Red blood cell disorder'}, {'cui': 'C2316810', 'cui_str': 'Chronic kidney disease stage 5'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.183522,The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption.,"[{'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Brautaset Englund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Østby', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vartdal', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1067']
2864,32464912,Revisiting an Old Concept in a New Era: 36 Hour Lung Preservation Using 10ºC Static Cold Storage.,"PURPOSE


Despite remote reports indicating 10°C to be the optimal temperature for cold static organ preservation (CSP), preservation of lungs in an ice cooler at 4°C remains the standard strategy in clinical transplantation. Here, we used a commercially available device that can keep a donor lung at 10°C conveniently and compared 10°C vs. 4°C during a prolonged period of CSP followed by functional and biological assessment of lung grafts.
METHODS


Lungs were procured from Yorkshire pigs (28-35kg), flushed with a low-potassium dextran solution and randomized into two groups (n=5 each): CSP at 4°C vs. CSP at 10°C (MyTemp Mini Incubator, Benchmark Scientific). After 36h of CSP, lungs were subjected to 12h of normothermic ex vivo lung perfusion (EVLP) with hourly functional assessment. Lung biopsies and perfusate samples were taken for biological and metabolic evaluation.
RESULTS


During 12h of EVLP, lungs stored at 10°C presented superior physiological parameters compared to 4°C (Fig 1A). Reduced edema formation was seen as represented by a lower lung weight gain during EVLP (30 ± 34.1 vs. 201 ± 33.2 g, p = 0.0159). Metabolic profiles of the EVLP perfusate were significantly more favorable in the 10°C group compared to 4°C (Fig 1B). Furthermore, the 10°C group had significantly less inflammation demonstrated by lower levels of pro-inflammatory cytokines IL-1β (p = <0.0001, Fig 1C), and IL-8 (p = <0.0001, Fig 1C) in the EVLP perfusate. The levels of IL-6 were significantly lower in both EVLP perfusate (p = <0.0001, Fig 1C) and post-perfusion lung tissue (p = 0.0317). Immunohistochemical analysis for 8-Hydroxyguanosine demonstrated that lungs stored at 10°C tended to have less oxidative stress during CSP (p = 0.0952).
CONCLUSION


With simple controllable refrigerators, 10°C preservation is easily achievable and provides significantly superior CSP in comparison to conventional 4°C storage. This could potentially remarkably improve the clinical and transportation logistics in lung transplantation.",2020,"The levels of IL-6 were significantly lower in both EVLP perfusate (p = <0.0001, Fig 1C) and post-perfusion lung tissue (p = 0.0317).","['Lungs were procured from Yorkshire pigs (28-35kg), flushed with a']","['CSP', 'low-potassium dextran solution', 'normothermic ex vivo lung perfusion (EVLP) with hourly functional assessment']","['IL-8', 'Metabolic profiles of the EVLP perfusate', 'lung weight gain', 'oxidative stress', 'levels of IL-6', 'edema formation', 'levels of pro-inflammatory cytokines IL-1β ']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0324292', 'cui_str': 'Yorkshire pig'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0029209', 'cui_str': 'Organ preservation'}, {'cui': 'C0860866', 'cui_str': 'Potassium low'}, {'cui': 'C0086140', 'cui_str': 'Dextran'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.0254096,"The levels of IL-6 were significantly lower in both EVLP perfusate (p = <0.0001, Fig 1C) and post-perfusion lung tissue (p = 0.0317).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gomes', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galasso', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hough', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Beronical', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Waddell', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Andreazza', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1074']
2865,32464944,Reversal of Frailty after LVAD Associated with Significant Reduction in Markers of Inflammation.,"PURPOSE


Inflammation has been implicated in frailty seen in heart failure (HF), and macrophage migration inhibitory factor (MIF) has been associated with worse outcomes in HF. Assessment of frailty is key in determining eligibility for advanced therapies (AT). Most programs use a subjective assessment (SA), but the Modified Fried Frailty Index (mFFI) has been widely validated. We assessed MIF levels in patients referred for AT and the changes in mFFI and MIF after LVAD. Additionally, we compared SA to mFFI testing in patients referred for AT.
METHODS


All patients referred for evaluation for AT underwent SA and mFFI assessments and blood testing for MIF. Three providers (Ps) independently assessed patients to be frail or not frail (SA). mFFI assigns a frailty point in each of five domains: weight loss, fatigue, activity, walk time, and strength. Patients are frail when scored ≥ 3. Patients who underwent LVAD were reevaluated for mFFI and MIF at 3 and 6 months.
RESULTS


Over 18 months, 54 subjects (61±11 yrs) were studied, 11 underwent LVAD. Frail patients were older, and had lower albumin and Hb. SA significantly underestimated frailty compared to mFFI (3-23% vs. 60%, p<0.001) (Fig. 1A). Correlation between SA and mFFI was not strong (42-58% agreement, κ< 0.04). Most of the time, Ps were correct when designating a patient as frail and incorrect when designating a patient as not frail. Agreement between all 3 Ps was strong (71.4%, W= .34). Baseline MIF was elevated in AT patients (311±128 pg/mL). mFFI scores improved in all patients by 6 months after LVAD, such that they were significantly lower than baseline (2.9±1.4 vs. 0.9±0.9, p<0.003), with no patients being assessed as frail. In parallel, MIF significantly decreased after LVAD (Fig. 1B).
CONCLUSION


SA significantly underestimates frailty as compared to mFFI. Both frailty scores and MIF improved after LVAD, suggesting reversibility of the frailty syndrome. Understanding frailty will be key to improving outcomes in advanced HF.",2020,"SA significantly underestimated frailty compared to mFFI (3-23% vs. 60%, p<0.001) (Fig. 1A).","['patients referred for AT', 'Frail patients were older, and had lower albumin and Hb', '54 subjects (61±11 yrs) were studied, 11 underwent LVAD', 'Three providers (Ps) independently assessed patients to be frail or not frail (SA']",['LVAD'],"['weight loss, fatigue, activity, walk time, and strength', 'Baseline MIF', 'MIF levels', 'mFFI scores', 'Markers of Inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0860864', 'cui_str': 'Decreased albumin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024429', 'cui_str': 'Macrophage inhibitory factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C4075885', 'cui_str': 'Frailty Index score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0457169,"SA significantly underestimated frailty compared to mFFI (3-23% vs. 60%, p<0.001) (Fig. 1A).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Knisel', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elyasi', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gibson', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Research Division, RDS2 Solutions, Stony Brook, NY.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fernandez', 'Affiliation': 'Cardiovascular & Thoracic Surgery, North Shore University Hospital, Manhasset, NY.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lima', 'Affiliation': 'Cardiovascular & Thoracic Surgery, North Shore University Hospital, Manhasset, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Cardiovascular & Thoracic Surgery, North Shore University Hospital, Manhasset, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Davidson', 'Affiliation': 'Cardiovascular & Thoracic Surgery, North Shore University Hospital, Manhasset, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Malhame', 'Affiliation': 'Cardiovascular & Thoracic Surgery, North Shore University Hospital, Manhasset, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'St. Lukes Hospital, Kansas City, MO.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Majure', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stevens', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maybaum', 'Affiliation': 'Cardiology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1104']
2866,32465000,Validation of REVEAL Risk Score Calculator 2.0 in Patients with PAH in the Phase III PATENT Study.,"PURPOSE


The REVEAL risk score (RRS) predicts 1-year survival in patients with pulmonary arterial hypertension (PAH). RRS was shown previously to improve with riociguat in the Phase III PATENT-1 study in patients with PAH and predicted survival and clinical worsening-free survival (CWFS) in the long-term extension PATENT-2. RRS 2.0, an updated RRS, was developed based on modified point values, cut-offs, and variables. This post hoc analysis aimed to validate RRS 2.0 in the PATENT database (a population not derived from REVEAL), as done previously, and assess if the tool discriminates outcomes in a carefully selected and followed patient population.
METHODS


RRS 2.0 was calculated for patients receiving riociguat up to 2.5 mg tid or placebo (pbo) at PATENT-1 baseline (BL) and Week 12, and PATENT-2 Week 12. Only patients enrolled in PATENT-2 were included in the analysis. Patients were stratified by RRS 2.0 into low (≤7), average/moderately high (8-9), and high/very high (≥10) risk strata at BL and Week 12. Relationship between RRS 2.0 and survival and CWFS in PATENT-2 was examined by Kaplan-Meier and Cox proportional hazards analyses.
RESULTS


At BL, mean±SD RRS 2.0 was 6.5±2.6 in riociguat patients (n=231) and 6.4±2.2 in pbo patients (n=109). Risk status at BL was low in 213 patients (63%), average/moderately high in 87 (26%), and high/very high in 40 (12%). At PATENT-1 Week 12, patients receiving riociguat had improved RRS 2.0 by a least squares mean difference of -0.95 vs. pbo (95% CI -1.35 to -0.55; p<0.0001); risk status improved in 57% of patients with riociguat and 42% of patients with pbo (p<0.0001). At PATENT-2 Week 12, RRS 2.0 had improved to 5.1±2.7 (n=224) and 5.6±2.7 (n=107) in riociguat and former pbo patients, respectively. In PATENT-2 (median [range] treatment duration: 139 [0-244] weeks), Cox proportional hazards analyses showed that RRS 2.0 at PATENT-1 BL and Week 12 were significantly associated with survival and CWFS (p<0.0001). Kaplan-Meier analyses showed significant differences in survival and CWFS between patients in the three risk strata at PATENT-1 BL and Week 12 (p<0.0001).
CONCLUSION


Riociguat improved RRS 2.0 and risk strata in PATENT-1. RRS 2.0 predicted survival and CWFS over two years in PATENT-2, making RRS 2.0 a useful tool to predict outcomes in patients with PAH. Further assessment of the discriminatory power of RRS 2.0 vs. the original RRS will be done.",2020,"At PATENT-1 Week 12, patients receiving riociguat had improved RRS 2.0 by a least squares mean difference of -0.95 vs. pbo (95% CI -1.35 to -0.55; p<0.0001); risk status improved in 57% of patients with riociguat and 42% of patients with pbo (p<0.0001).","['Patients were stratified by RRS 2.0 into low (≤7), average/moderately high (8-9), and high/very high (≥10) risk strata at BL and Week 12', 'patients with PAH', 'patients with pulmonary arterial hypertension (PAH']",['placebo'],"['Risk status at BL', 'survival and CWFS', 'survival and clinical worsening-free survival (CWFS', 'risk status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.060327,"At PATENT-1 Week 12, patients receiving riociguat had improved RRS 2.0 by a least squares mean difference of -0.95 vs. pbo (95% CI -1.35 to -0.55; p<0.0001); risk status improved in 57% of patients with riociguat and 42% of patients with pbo (p<0.0001).","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Benza', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Farber', 'Affiliation': 'Pulmonary Hypertension Center, Boston University/Boston Medical Center, Boston, MA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Frost', 'Affiliation': 'Department of Medicine, Houston Methodist, Houston, TX.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Member of the German Center for Lung Research (DZL), University of Giessen and Marburg Lung Center (UGMLC), Glessen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Corris', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brockmann', 'Affiliation': 'CHRESTOS Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nikkho', 'Affiliation': 'Global Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meier', 'Affiliation': 'Global Medical Affairs, Bayer AG, Berlin, Germany.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Clinic for Respiratory Medicine, Hannover Medical School, member of the German Center for Lung Research (DZL), Hannover, Germany.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1144']
2867,32465013,The Impact of HeartMate 3 Speed on Outcomes in the Momentum 3 Clinical Trial.,"PURPOSE


Durable continuous flow left ventricular assist devices (LVADs) operate at a fixed speed set by the clinician. Within Momentum 3, a large multicenter clinical trial of a magnetically levitated centrifugal LVAD, we sought to characterize pump speeds utilized, identify clinical variables associated with speed selection, and determine if early speed setting was independently associated with major adverse events.
METHODS


Momentum 3 was a prospective randomized clinical trial comparing the HeartMate II and HeartMate 3 (HM3) in advanced heart failure. Multivariate linear regression analyses were used to identify baseline clinical factors associated with HM3 speed setting at implant and discharge. The negative binomial model was used to determine if pump speed at implant or discharge from the index hospitalization was independently associated with a composite endpoint of death, transplant for pump thrombosis, and the occurrence of hemocompatibility related adverse events: bleeding due to surgical or non-surgical causes, any stroke, suspected or confirmed pump thrombosis or peripheral arterial thromboembolism.
RESULTS


There were 514 patients implanted with the HM3 that had speed data available for analysis. Median speed at implant was lower than all other time points through 180 days (Figure). Baseline clinical variables independently associated with higher pump speed at implant were increasing body surface area (BSA, p=0.003) and left ventricular end diastolic diameter (LVEDD, p=0.008), and at hospital discharge were BSA (p<0.001), younger age (p=0.001), male gender (p=0.01), and LVEDD (p=0.049). HM3 speed at implant and discharge were not independently associated with the composite adverse event endpoint.
CONCLUSION


Within the Momentum 3 clinical trial, HM3 speed was significantly lower at implant compared to other time points up to 180 days. Younger age, male gender, larger BSA and LVEDD were associated with higher pump speeds. Early HM3 speed was not independently associated with adverse events.",2020,"Within the Momentum 3 clinical trial, HM3 speed was significantly lower at implant compared to other time points up to 180 days.","['514 patients implanted with the HM3 that had speed data available for analysis', 'advanced heart failure']",['HeartMate II and HeartMate 3 (HM3'],"['Median speed at implant', 'body surface area (BSA, p=0.003) and left ventricular end diastolic diameter (LVEDD, p=0.008), and at hospital discharge', 'adverse events', 'HM3 speed at implant and discharge', 'HM3 speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",514.0,0.0724285,"Within the Momentum 3 clinical trial, HM3 speed was significantly lower at implant compared to other time points up to 180 days.","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Haft', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Silvestry', 'Affiliation': 'Advent Health Orlando, Orlando, FL.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Ransom', 'Affiliation': 'Baptist Health Medical Center, Little Rock, AR.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Washington University, St. Louis, MO.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lowes', 'Affiliation': 'University of Nebraska, Omaha, NE.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Bhama', 'Affiliation': 'Baptist Health Medical Center, Little Rock, AR.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Spectrum Health, Grand Rapids, MI.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rapkin', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Franke', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Estep', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.769']
2868,32465030,ICD Therapy Confers No Survival Advantage in a Global LVAD Population: Insights from the Trans-Atlantic Registry on VAD and Transplant (TRAViATA).,"PURPOSE


There are conflicting data related to the use of implantable cardioverter-defibrillators (ICDs) in patients supported with continuous-flow ventricular assist devices (LVADs). Several US studies have shown a neutral effect on mortality, whereas a recent European study suggested better outcomes in LVAD patients who have an ICD. We aimed to investigate the benefit of ICDs in patients bridged to transplant with a LVAD in the TRans-Atlantic registry on VAd and TrAnsplant (TRAViATA).
METHODS


Data from consecutive patients that received a LVAD as a bridge to transplantation between January 2008 and April 2017 were collected in 7 EU (n=299) and 3 US centers (n=225). Survival analysis was performed using Kaplan-Meier and Cox proportion hazard regression analysis. Patients were censored at time of transplantation.
RESULTS


Patients with an ICD at the time of LVAD (n=350) implantation were older (56 vs. 53 years, p<0.05), less likely to be female (13% vs. 21%, p<0.05) and to have ischemic cardiomyopathy (39% vs. 52%, p<0.05) compared to patients without an ICD (n=174). The proportion of patients with an ICD/LVAD was 66% in the EU and 68% in the US (p=0.49). Overall survival after LVAD was 86% at one year and 76% at two years. There was no difference in survival in patients with and without an ICD (Figure). These results were consistent when analyzing patients from each continent separately (Figure). In univariate Cox-regression age at time of implant and INTERMACS profile were associated with mortality (p<0.05) whereas presence of ICD was not. Sensitivity analysis excluding patients who received their ICD (n=25) after LVAD confirmed the results.
CONCLUSION


In this retrospective study of LVAD patients from the EU and US ICD therapy conferred no survival advantage irrespective of geographic location. A prospective, randomized, trial of LVAD patients who have an existing ICD randomized to tachyarrhythmia therapy discontinuation is needed to validate these findings.",2020,In this retrospective study of LVAD patients from the EU and US ICD therapy conferred no survival advantage irrespective of geographic location.,"['patients who received their ICD (n=25) after LVAD confirmed the results', 'Patients with an ICD at the time of LVAD (n=350) implantation were older (56 vs. 53 years, p<0.05', 'LVAD patients who have an existing ICD randomized to', 'patients bridged to transplant with a LVAD in the TRans-Atlantic registry on VAd and TrAnsplant (TRAViATA', 'Data from consecutive patients that received a LVAD as a bridge to transplantation between January 2008 and April 2017 were collected in 7 EU (n=299) and 3 US centers (n=225', 'LVAD patients who have an ICD']","['EU and US ICD therapy', 'implantable cardioverter-defibrillators (ICDs', 'ICD Therapy', 'LVAD', 'tachyarrhythmia therapy discontinuation']","['survival', 'Overall survival', 'ischemic cardiomyopathy', 'Survival analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0077973', 'cui_str': 'VAD I protocol'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",,0.0378723,In this retrospective study of LVAD patients from the EU and US ICD therapy conferred no survival advantage irrespective of geographic location.,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Braun', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brambatti', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cipriani', 'Affiliation': 'De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veenis', 'Affiliation': 'Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Bui', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hong', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'C Van', 'Initials': 'CV', 'LastName': 'de Heyning', 'Affiliation': 'Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perna', 'Affiliation': 'De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'University Hospital, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cikes', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gjesdal', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Partida', 'Affiliation': 'UCSF, Division of Cardiology, San Francisco, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Potena', 'Affiliation': 'Academic Hospital S. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Masetti', 'Affiliation': 'Academic Hospital S. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Loforte', 'Affiliation': 'Academic Hospital S. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jakus', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Bock', 'Affiliation': 'Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Minto', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brugts', 'Affiliation': 'Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sterken', 'Affiliation': 'University Hospital, Leuven, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Van den Bossche', 'Affiliation': 'University Hospital, Leuven, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rega', 'Affiliation': 'University Hospital, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sing', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Russo', 'Affiliation': 'De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pretorius', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'UCSF, Division of Cardiology, San Francisco, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frigerio', 'Affiliation': 'De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Adler', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ammirati', 'Affiliation': 'De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.783']
2869,32465036,Cryoanalgesia Reduces Postoperative Pneumonia in Patients Undergoing Double Lung Transplantation Compared to Thoracic Paravertebral Catheters and Traditional Opiate Based Analgesia.,"PURPOSE


Postoperative pain for bilateral lung transplant patients is often poorly controlled and may negatively impact recovery. Intercostal cryoanalgesia (IC-CRYO) may provide an additional modality to pain control. We hypothesize that IC-CRYO may enhance recovery compared to traditional opiate based analgesia (OBA) and thoracic paravertebral catheter (TPVC) analgesia.
METHODS


Consecutive patients from January 2015 to May 2019 receiving a double lung transplant were included in this retrospective review. Pediatric age, single lung and redo lung transplants were excluded. TPCV group received 4 bilateral catheters at T4 and T8 levels postoperatively in the intensive care unit. IC-CRYO was performed intraoperatively by the surgeon from intercostal nerves 3-7 bilaterally.
RESULTS


A total of 66 patients received IC-CRYO, 51 patients received OBA, and 89 received TPVC. The IC-CRYO group was significantly older (59 vs 52; p = 0.01) and had higher BMI (25.8 vs 24.2; p = 0.05) compared to OBA. Both the restrictive lung disease patients (62% IC-CRYO, 46% TPVC and 47% OBA) and the lung allocation scores (52 IC-CRYO, 47 TPVC and 51 OBA) were higher in IC-CRYO. There were no differences in time on the ventilator, ICU or hospital length of stay. There was a trend to lesser need for tracheostomy in IC-CRYO compared to OBA (5% vs 16%; p = value 0.06). IC-CRYO showed a significant decrease in post operative pneumonia compared to OBA (3% vs 22%; p = 0.03) and to TPVC (3% vs 17%; p = 0.03). There were no complications related to TPVC or IC-CRYO.
CONCLUSION


The present data suggest IC-CRYO and TPVC are effective as adjuncts to pain control for patients undergoing bilateral lung transplant. The data suggest IC-CRYO is strongly associated with functional improvements in patient recovery from bilateral lung transplant when compared with TPVC and OBA for postoperative pain control.",2020,The IC-CRYO group was significantly older (59 vs 52; p = 0.01) and had higher BMI (25.8 vs 24.2; p = 0.05) compared to OBA.,"['Pediatric age, single lung and redo lung transplants', '66 patients received', 'patients undergoing bilateral lung transplant', 'Consecutive patients from January 2015 to May 2019 receiving a double lung transplant', 'bilateral lung transplant patients', 'Patients Undergoing Double Lung Transplantation']","['IC-CRYO and TPVC', 'Thoracic Paravertebral Catheters and Traditional Opiate Based Analgesia', 'TPCV', 'Cryoanalgesia', 'OBA, and 89 received TPVC', 'Intercostal cryoanalgesia (IC-CRYO', 'TPVC and OBA', 'IC-CRYO']","['higher BMI', 'Postoperative Pneumonia', 'lung allocation scores', 'post operative pneumonia', 'time on the ventilator, ICU or hospital length of stay']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0396599', 'cui_str': 'Double lung transplant'}]","[{'cui': 'C0524318', 'cui_str': 'Cryoanalgesia'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1279386', 'cui_str': 'Postoperative pneumonia'}, {'cui': 'C4720844', 'cui_str': 'Lung allocation score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",66.0,0.101131,The IC-CRYO group was significantly older (59 vs 52; p = 0.01) and had higher BMI (25.8 vs 24.2; p = 0.05) compared to OBA.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Gerber', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pipkin', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tighe', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Scheuble', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chandrashekaran', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahmohammadi', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alnuaimat', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Emtiazjoo', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Arnaoutakis', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jeng', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Beaver', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Oduntan', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pelaez', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Machuca', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.789']
2870,32465171,Remote Dielectric Sensing (ReDS) for a Safe Discharge in Patients with Acutely Decompensated Heart Failure: Rationale and Design of the ReDS-SAFE HF Study.,"OF OBJECTIVES


Fluid overload, especially pulmonary congestion, is one of the main contributors into heart failure (HF) readmission risk and it is a clinical challenge for clinicians. The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively. Previous non-randomized studies suggest that ReDS-guided management has the potential to reduce readmissions in HF patients recently discharged from the hospital. The aim of this study is to test whether a ReDS-guided strategy during HF admission is superior to the standard of care during a 1-month follow up.
METHODS


The ReDS-SAFE trial is an investigator-initiated, single center, single blind, 2-arm randomized clinical trial, in which 250 inpatients with acutely decompensate HF will be randomized to a) standard of care strategy, with a discharge scheme based on current clinical practice, or b) ReDS-guided strategy, with a discharge scheme based on specific target value given by the device. All patients will provide signed informed consent and the protocol will be approved by Institutional Review Board of the hospital. This study will be registered in ClinicalTrials.gov. Time to the primary endpoint will be evaluated with the use of Kaplan-Meier estimates and Cox proportional hazards models.
ENDPOINTS


The primary outcome will be a composite of unplanned visit for HF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge.",2020,The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively.,"['250 inpatients with acutely decompensate HF', 'Patients with Acutely Decompensated Heart Failure']","['Remote Dielectric Sensing (ReDS', 'discharge scheme based on current clinical practice, or b) ReDS-guided strategy, with a discharge scheme based on specific target value given by the device', 'ReDS-guided strategy']","['composite of unplanned visit for HF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",250.0,0.245997,The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alvarez-Garcia', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ullman', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Damato', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brunjes', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Cardiology, Mount Sinai Hospital, New York, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.912']
2871,32465175,Nitric Oxide Inhalation is Associated with Decreased Incidence of Acute Rejection after Cardiac Transplantation.,"PURPOSE


Inhaled nitric oxide (iNO) has been shown to decrease ischemia-reperfusion injury (IRI) by several putative mechanisms, while preclinical studies have shown it to reduce acute rejections. In heart transplantation (HTx), iNO is routinely used to decrease pulmonary vascular resistance. However, iNO's effect on IRI after HTx and later outcomes on acute rejections remains unknown.
METHODS


We performed post hoc analysis on clinical data and plasma samples of 84 donor-recipient pairs collected in a prospective, double-blinded single-center trial. Recipient plasma was collected prior to HTx, and 1, 6, 12, and 24h after transplantation. In addition cardiac biopsies were collected before and 1h after reperfusion, and 2 weeks after HTx. We measured TnT, TnI, CKMBm, and proBNP as biomarkers for early organ-specific injury and function. Follow-up was conducted until one year for rejections and mortality.
RESULTS


Of the 84 patients, 58.3% received iNO after HTx based on perioperative pulmonary vascular resistance. Preoperatively, iNO-treated patients had higher bilirubin and proBNP (P<0.01 and P<0.05), and a trend for higher transpulmonary gradient (P=0.058). Postoperatively, iNO-treated patients had higher TnT, TnI, and proBNP plasma levels (P<0.01-0.05), and an increased need for renal replacement therapy (P<0.001) compared to patients not receiving iNO. iNO-treated patients received more likely ATG, and therefore patients were divided to subgroups based on ATG and iNO treatment. In a 1-year follow-up, mortality between groups was similar. In groups without ATG treatment, iNO-treated patients had fewer biopsy-proven acute rejection episodes, and their 1-y freedom from rejection was higher (20% vs 52%) (both P<0.01). There was a similar, albeit statistically non-significant, trend for groups receiving ATG.
CONCLUSION


iNO-treated patients were sicker pre- and postoperatively compared to patients not receiving iNO. Despite iNO-patients being overall sicker, iNO-treatment associated with less rejections. Our findings suggest that iNO may have some long-term cardioprotective effects after HTx. In ISHLT 2020 meeting we aim to present also results on the effect of iNO on early inflammatory cell influx to the graft, and on changes in cardiac transcriptome using IHC and next-generation sequencing from cardiac biopsies.",2020,"We measured TnT, TnI, CKMBm, and proBNP as biomarkers for early organ-specific injury and function.",['Acute Rejection after Cardiac Transplantation'],"['Nitric Oxide Inhalation', 'nitric oxide (iNO']","['pulmonary vascular resistance', '1-y freedom from rejection', 'perioperative pulmonary vascular resistance', 'biopsy-proven acute rejection episodes', 'bilirubin and proBNP', 'higher TnT, TnI, and proBNP plasma levels']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041070', 'cui_str': 'Trinitrotoluene'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0753355,"We measured TnT, TnI, CKMBm, and proBNP as biomarkers for early organ-specific injury and function.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmström', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Syrjälä', 'Affiliation': 'Transplantation Laboratory; Cardiac Surgery, University of Helsinki; Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krebs', 'Affiliation': 'Transplantation Laboratory, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nykänen', 'Affiliation': 'Transplantation Laboratory; Cardiac Surgery, University of Helsinki; Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Lemstrom', 'Affiliation': 'Transplantation Laboratory; Cardiac Surgery, University of Helsinki; Helsinki University Hospital, Helsinki, Finland.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.915']
2872,32465234,Comparison of Six-Month Outcomes in Restrictive Cardiomyopathy Patients before and after UNOS Allocation System Change.,"PURPOSE


Restrictive cardiomyopathy (RCM) patients represent a spectrum of disorders. Given the greater emphasis for status exceptions for RCM pts in the new allocation system, we sought to assess whether this change in the allocation policy would affect the wait list and post-transplant outcomes in RCM pts.
METHODS


89 RCM pts were identified in the UNOS registry that underwent heart transplant (HT) during a 6-mos period immediately before and after UNOS policy change. Comparisons between pt characteristics in the pre (n=62) and post (n=27) policy-change cohorts are reported using standard statistical methods; survival analysis performed using Cox proportional hazards modeling.
RESULTS


The waitlist (WL) statuses of the pre pts were 1A (n=34), 1B (n=14), 2 (n=14) while the WL statuses of the post pts were 1 (n=2), 2 (n=13), 3 (n=5), 4 (n=4), 6 (n=2). For the pre and post policy groups, the age, gender, ethnicity, DM status, and ischemic times were similar. The RCM subtype (idiopathic, amyloid, sarcoid, chemo/XRT, and other) distribution was similar for the two groups. Donor age was greater following policy change (40.6 ± 13.0 vs 30.7± 13.0, p=<0.01). Median total days on WL trended towards fewer days for post group (16.0 days vs 33.0 days, p=0.06). IABP utilization was greater for the post policy change group (37% vs 5%, p=<0.01). There was no significant survival difference at 6 month.
CONCLUSION


After UNOS policy change, the 6 months post HT mortality was unchanged in RCM pts as compared to pre-policy change. There was a trend towards shorter wait times and significantly greater utilization of IABP after policy change. Despite the emphasis on status exception for RCM pts, there were fewer overall HT done for RCM.",2020,"IABP utilization was greater for the post policy change group (37% vs 5%, p=<0.01).",['89 RCM pts were identified in the UNOS registry that underwent heart transplant (HT) during a 6-mos period immediately before and after UNOS policy change'],[],"['survival difference', 'IABP utilization', 'HT mortality', 'Median total days on WL', 'utilization of IABP', 'shorter wait times']","[{'cui': 'C0007196', 'cui_str': 'Restrictive cardiomyopathy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.03555,"IABP utilization was greater for the post policy change group (37% vs 5%, p=<0.01).","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Li', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kingsford', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pandya', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fong', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Grazette', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nattiv', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Genyk', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vucicevic', 'Affiliation': 'Internal Medicine, Newark Beth-Israel Medical Center, Newark, NJ.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chand', 'Affiliation': 'Internal Medicine, Harbor-UCLA Medical Center, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiankhooy', 'Affiliation': 'Internal Medicine, LAC+USC, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wolfson', 'Affiliation': 'Internal Medicine, University of Arizona Sarver Heart Center, Tuscon, AZ.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'DePasquale', 'Affiliation': 'Cardiology, Keck Medicine of USC, Los Angeles, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.571']
2873,32465245,The Effect of the New UNOS Heart Allocation on Donation Service Area and Heart Transplant Program Logistics: The Mid America Experience.,"PURPOSE


A revised U.S. heart allocation system (HAS) instituted 10/18/18 was designed to eliminate donation service area (DSA) boundaries/reduce geographic disparity. The new status 1-3 is equivalent to the old status 1A. The effect of HAS change on DSA and heart transplant program (HTP) logistics are unknown. We report our DSA and HTP experience 1 year later.
METHODS


Data from 2 groups of patients defined by date of transplant were analyzed: pre HAS change (PRE, 10/18/17-10/17/18) and post HAS change (POST, 10/18/18-9/30/19). The data from our local DSA and our HTP PRE and POST are reported separately.
RESULTS


Our local DSA has 2 adult/1 pediatric HTPs. During the PRE, the DSA recovered 65 adult hearts (30 allocated to our HTP, 13 to 2nd adult HTP, 1 to pediatric HTP). 21 hearts were allocated outside of the DSA (32.3%). 40 hearts were allocated to status 1A (62%). During the POST, the DSA recovered 75 adult hearts (10 allocated to our HTP, 4 to 2nd adult HTP). 61 (81.3%) hearts were allocated outside the DSA. 84% were allocated to the old status 1A equivalent (new status 1-3). Table illustrates our HTP statistics PRE and POST. 38 transplants were performed PRE, and 40 performed POST. Cold ischemic time increased 21% from 161 to 195 minutes. Flights were required in 15 PRE and 34 POST cases. While the miles per flight were similar PRE and POST (331 vs 354 nautical miles [nm]), the total nm increased 2.4 fold from 4969 to 12032. Travel time increased 25% from 251 to 315 minutes. Total organ acquisition cost increased 36% per transplant POST vs PRE.
CONCLUSION


After HAS change, 81% (vs 32%) of hearts were allocated outside the DSA and to the most urgent statuses (84 vs 62%). HAS change led to significant increase in cold ischemic time (21%), travel time (25%)/distance (242%), need for procurement team flyout (34 vs 15) and per transplant organ acquisition cost (36%). Further analysis are needed to examine the impact of HAS on procurement logistics, HTP cost, surgeon travel safety and post transplant survival.",2020,"HAS change led to significant increase in cold ischemic time (21%), travel time (25%)/distance (242%), need for procurement team flyout (34 vs 15) and per transplant organ acquisition cost (36%).","['40 hearts', '21 hearts', 'Data from 2 groups of patients defined by date of transplant were analyzed: pre HAS change (PRE, 10/18/17-10/17/18) and post HAS change (POST, 10/18/18-9/30/19']",[],"['Cold ischemic time', 'transplant organ acquisition cost', 'cold ischemic time', 'Total organ acquisition cost', 'Travel time', 'travel time (25%)/distance']","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",[],"[{'cui': 'C1563922', 'cui_str': 'Cold Ischemic Time'}, {'cui': 'C0524930', 'cui_str': 'Organ Grafts'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",38.0,0.0297107,"HAS change led to significant increase in cold ischemic time (21%), travel time (25%)/distance (242%), need for procurement team flyout (34 vs 15) and per transplant organ acquisition cost (36%).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kao', 'Affiliation': ""Cardiology, St Luke's Mid America Heart Institute, Kansas City, MO.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': ""Heart Transplant, St Luke's Mid America Heart Institute, Kansas City, MO.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'May', 'Affiliation': ""Heart Transplant, St Luke's Mid America Heart Institute, Kansas City, MO.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Markham', 'Affiliation': 'Midwest Transplant Network, Westwood, KS.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dickerson', 'Affiliation': ""Heart Transplant, St Luke's Mid America Heart Institute, Kansas City, MO.""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Borkon', 'Affiliation': ""Cardiothoracic Surgery, St Luke's Mid America Heart Institute, Kansas City, MO.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.581']
2874,32471214,Total Hip Arthroplasty Using Imageless Computer-Assisted Navigation-2-Year Follow-Up of a Prospective Randomized Study.,"The purpose of this study is to compare computer-assisted to manual implantation-techniques in total hip arthroplasty (THA) and to find out if the computer-assisted surgery is able to improve the clinical and functional results and reduce the dislocation rate in short-terms after THA. We performed a concise minimum 2-year follow-up of the patient cohort of a prospective randomized study published in 2014 and evaluated if the higher implantation accuracy in the navigated group can be seen as an important determinant of success in total hip arthroplasty. Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up. The implantation accuracy in the navigated group can be regarded as an important determinant of success in THA, although no significant differences in clinical outcome could be detected at short-term follow-up. Therefore, further long-term follow-up of our patient group is needed.",2020,"Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up.","['total hip arthroplasty (THA', 'total hip arthroplasty']","['computer-assisted to manual implantation-techniques', 'computer-assisted surgery']","['dislocation rate', 'implantation accuracy', 'mean postoperative acetabular component anteversion', 'clinical outcome or revision rates', 'Total Hip Arthroplasty']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]",,0.0177396,"Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lass', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Olischar', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kubista', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Waldhoer', 'Affiliation': 'Department of Epidemiology, Center of Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090 Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Giurea', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9061620']
2875,32471226,Proximal Tibiofibular Dislocation in a Closing-Wedge High Tibial Osteotomy Causes Lateral Radiological Gapping of the Knee: A Prospective Randomized Study.,"BACKGROUND


To determine whether a proximal tibiofibular joint dislocation (TFJD) increases lateral compartment gapping more than a fibular head osteotomy (FHO) during a closing-wedge high tibial osteotomy (CWHTO). The second objective was to determine whether lateral compartment gapping affects clinical outcomes.
METHODS


A prospective randomized clinical study was carried out that included 18 patients in Group 1 (FHO) and 18 in Group 2 (TFJD). Varus-stress radiographs of all the patients with both knees at full extension and at 30 ° of flexion were studied pre-operatively and 12 months post-operatively. Lateral compartment gapping was measured in millimeters. The Knee Society Score (KSS) was used to assess clinical stability.
RESULTS


The difference between the pre- and post-operative measurements relative to gapping in the lateral knee compartment at 0 ° of knee flexion was 1.3 mm (SD 1.8) in Group 1 and 4.5 mm (SD 2.4) in Group 2 ( p   =  0.006). At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p   =  0.01). No differences were observed in the pre- and post-operative period relative to gapping in healthy knees. Pre-operatively, both groups presented similar KSS knee values: Group 1 with 54.7 (SD 11.7), Group 2 with 54.8 (SD 11.1) (n.s.). Post-operatively, these values were also similar: Group 1 with 93.2 (SD 7.4), Group 2 with 93.5 (SD 5.5) (n.s.).
CONCLUSIONS


In patients who have undergone a CWHTO, TFJ dislocation increases knee lateral compartment gapping when compared to an FHO at 0 ° and 30 ° of knee flexion. However, this fact seems to have no repercussion on the functional status of the knees as measured with the KSS at the one-year follow-up.",2020,"At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p   =  0.01).","['Proximal Tibiofibular Dislocation in a Closing-Wedge High Tibial Osteotomy Causes Lateral Radiological Gapping of the Knee', 'included 18 patients in Group 1 (FHO) and 18 in Group 2 (TFJD']","['proximal tibiofibular joint dislocation (TFJD', 'TFJ dislocation']",['Knee Society Score (KSS'],"[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0223908', 'cui_str': 'Head of fibula structure'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0935532,"At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p   =  0.01).","[{'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Torres-Claramunt', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Sánchez-Soler', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Hinarejos', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Sala-Pujals', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Leal-Blanquet', 'Affiliation': ""Orthopaedic Department, Hospital de Igualada, Consorci Sanitari de l'Anoia, 08700 Barcelona, Spain.""}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Monllau', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061622']
2876,32471369,Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.,"BACKGROUND


Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes.
METHODS


A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion.
RESULTS


Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different.
CONCLUSION


Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards.
TRIAL REGISTRATION


This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.",2020,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"['registration number 13804902 on 15 November 2017', 'nulliparas with unripe cervixes', '86 participants were analysed', 'university hospital in Malaysia', 'Participants were nulliparas at term with unripe cervixes (Bishop Score\u2009≤\u20095) admitted for IoL who were randomized to', 'Nulliparas with unripe cervix']","['speculum insertion of Foley catheter', 'Transcervical procedure', 'digital or speculum-aided transcervical Foley catheter insertion in lithotomy position', 'Speculum versus digital insertion of Foley catheter', 'Digital and speculum insertion']","['uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate', 'maternal satisfaction VNRS score', 'pain score', 'Insertion duration', 'insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position'}]","[{'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",86.0,0.415544,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"[{'ForeName': 'Hang Min', 'Initials': 'HM', 'LastName': 'Chia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. pctan@um.edu.my.'}, {'ForeName': 'Sze Ping', 'Initials': 'SP', 'LastName': 'Tan', 'Affiliation': ""King's College London, The Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Mukhri', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zawiah', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03029-0']
2877,32471373,"Percutaneous mastoid electrical stimulator improves Poststroke depression and cognitive function in patients with Ischaemic stroke: a prospective, randomized, double-blind, and sham-controlled study.","BACKGROUND


Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function.
METHODS


This study was a prospective, randomized, double-blind, and sham-controlled study. A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N = 125) and sham plus antidepressant (sham group, N = 133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score ≤ 9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score < 26.
RESULTS


The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively). The mean value of the HRSD score change [M (month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (- 11.93 ± 5.32 vs - 10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores < 26 was lower in the PEMS group than in the sham group (12.0% vs 24.06%, P = 0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50 ± 2.55 vs 2.72 ± 2.52, P = 0.005, respectively).
CONCLUSION


These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition.
TRIAL REGISTRATION


This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018.",2020,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","['258 clinically depressed ischaemic stroke patients within 14\u2009days of index stroke', 'patients with Ischaemic stroke']","['PMES', 'PMES plus antidepressant (PMES group, N\u2009=\u2009125) and sham plus antidepressant', 'percutaneous mastoid electrical stimulator (PMES) plus antidepressants', 'Percutaneous mastoid electrical stimulator']","['mean value of the MoCA score change (M6-baseline', 'treatment response and depression remission', 'mean value of the HRSD score change [M (month)6-baseline', 'Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test', 'Poststroke depression and cognitive function', 'percentage of patients with a MoCA score\u2009<\u200926', 'poststroke depression and cognitive function', 'percentage of patients showing a treatment response', 'percentage of patients with MoCA scores', 'HRSD score) and depression remission (HRSD score']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",258.0,0.250207,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","[{'ForeName': 'Taoli', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China. 531324679@qq.com.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing, 400030, PR China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Electrical Engineering, Institute of Electrical Technology, Chongqing University, Chongqing, 400030, PR China.'}]",BMC neurology,['10.1186/s12883-020-01795-0']
2878,32471404,Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,"BACKGROUND


Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls.
METHODS


The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes.
RESULTS


A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22). Overall there were 36.4% improvement for knowledge (η p 2  = 0.21), 53.2% for the skills (η p 2  = 0.25), 19.5% for the self-efficacy (η p 2  = 0.11), and 25.6% for the beliefs (η p 2  = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time.
CONCLUSION


The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies.
TRIAL REGISTRATION


Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.",2020,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","['104 schoolchildren aged 11\u2009±\u20091.0\u2009years', 'spine-related behavior among pupils']","['theory-based back care intervention', 'six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing', 'educational program']","['rate of backache', 'knowledge, skills, self-efficacy, beliefs, and behavior', 'knowledge', 'knowledge, skills, beliefs, and self-efficacy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",104.0,0.0707787,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-08566-z']
2879,32471423,Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.,"BACKGROUND


The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD.
METHODS


207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 μg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 μg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV 1 ) < 50% predicted, or FEV 1  < 80% predicted and ≥ 2 moderate or 1 severe exacerbations in the prior year. The primary endpoint in both trials was weighted mean change from baseline (wmCFB) in 0-24-h FEV 1  at Week 12. Secondary endpoints included CFB in trough FEV 1  at Day 84 and 85. Other endpoints included serial FEV 1  and health status outcomes at Week 12. Safety was evaluated descriptively.
RESULTS


The modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1  at Week 12 (Study 207608 treatment difference [95% confidence interval]: 15 mL [- 13, 43]; Study 207609: 11 mL [- 20, 41]). FF/UMEC/VI improved trough FEV 1  CFB versus BUD/FOR+TIO at Day 84 and 85 (Day 85 treatment difference: Study 207608: 38 mL [10, 66]; Study 207609: 51 mL [21, 82]) and FEV 1  at 12 and 24 h post-morning dose at Week 12 in both studies. No treatment differences were seen in health status outcomes. Safety profiles were similar between treatments; pneumonia occurred in 7 (< 1%) patients with FF/UMEC/VI and 9 (1%) patients with BUD/FOR+TIO, across both studies.
CONCLUSIONS


FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1  at Week 12 in patients with COPD. Greater improvements in trough and serial FEV 1  measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
TRIAL REGISTRATION


GSK (207608/207609; NCT03478683/NCT03478696).",2020,"Greater improvements in trough and serial FEV 1  measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
","['207608 and 207609 were Phase IV', 'Study 207608: 38\u2009mL', '720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732', '10, 66]; Study 207609: 51\u2009mL [21, 82]) and FEV 1  at 12 and 24\u2009h post-morning dose at Week 12 in both studies', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD: lung function and health status']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25\u2009μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12\u2009μg via metered-dose inhaler plus once-daily tiotropium', 'inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy', 'Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy', 'single- with multiple-inhaler ICS/LAMA/LABA combination']","['symptomatic COPD and forced expiratory volume', 'health status outcomes', 'CFB in trough FEV', 'weighted mean change from baseline (wmCFB', 'Safety profiles', 'FF/UMEC/VI improved trough', 'pneumonia', 'serial FEV 1  and health status outcomes']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}]",,0.691451,"Greater improvements in trough and serial FEV 1  measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
","[{'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Corbridge', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dorais', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sciurba', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Stiegler', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center and Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA. bernstdd@ucmail.uc.edu.'}]",Respiratory research,['10.1186/s12931-020-01360-w']
2880,32471469,Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol.,"BACKGROUND


Intimate partner violence (IPV) is a leading threat to women's health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya.
METHODS


A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman's inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group.
DISCUSSION


Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited.
TRIAL REGISTRATION


Pan African Clinical Trial Registry approval received 25 April 2018 (PACTR201804003321122); retrospectively registered.",2020,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","['Intimate partner violence (IPV', 'women in low and middle income country settings', 'women reporting IPV or fear of partner and living in an urban settlement']",['community-partnered\xa0technology-based IPV intervention'],"['safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.147335,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA. mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}]",BMC public health,['10.1186/s12889-020-08901-4']
2881,32471476,NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial.,"BACKGROUND


The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal.
METHODS


We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N 1  = 200) and prediabetes (N 2  = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. Outcomes will be analyzed on an intention-to-treat basis.
DISCUSSION


The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.",2020,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
","['for people with Diabetes (N 1 \u2009=\u2009200) and prediabetes (N 2 \u2009=\u20091036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts', 'people with Diabetes and prediabetes (NUCOD) in Nepal']","['NUCOD program', 'NUrse-led COntinuum of care']","['glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.128419,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
","[{'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rubee', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts, Boston, MA, USA.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pushpanjali', 'Initials': 'P', 'LastName': 'Shakya', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Prabin Raj', 'Initials': 'PR', 'LastName': 'Shakya', 'Affiliation': 'College of Dentistry, Biomedical Knowledge Engineer Lab, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Biraj Man', 'Initials': 'BM', 'LastName': 'Karmacharya', 'Affiliation': 'Department of Community Programs, Kathmandu University School of Medical Sciences, Dhulikhel Hospital, Kavre, Nepal. birajmk@kusms.edu.np.'}]",Trials,['10.1186/s13063-020-04372-5']
2882,32471494,High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial.,"BACKGROUND


Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly common intervention in the treatment of pancreaticobiliary disorders. Patients are often elderly with complex co-morbidities. While monitored anaesthesia care with sedation is commonly used for most cases, few would require general anaesthesia with an endotracheal tube. Both low-flow and high-flow nasal cannulas (HFNC) are established ways of delivering supplemental oxygen, but it is unclear whether one technique is better than the other. HFNC seems a promising tool for advanced procedures but evidence to support its application in high-risk ERCP cases is limited. The rate of oxygen desaturation during endoscopy has been reported to be as high as 11%-50% and the method of oxygen delivery for ERCP merits further study.
METHODS/DESIGN


This is a prospective, randomised, multicentre trial comparing the efficacy of oxygen supplementation through HFNC versus low-flow nasal cannula during ERCP, in a cohort of patients at risk of adverse respiratory events. A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group. The primary outcome is the proportion of patients experiencing hypoxia, defined by any event of SpO2 < 90%. The secondary outcomes include parameters centred on oxygenation, requirement of airway manoeuvres, successful completion of procedure, perioperative complications, patient satisfaction and cost analysis of the consumables. An intention-to-treat principle will be applied while analysing.
DISCUSSION


The demand for ERCPs is likely to increase in the future with the aging population. Our study results may lead to improved outcomes and reduce airway-related complications in patients undergoing ERCPs. The results will be presented at national and international meetings and published in peer-reviewed journals.
TRIAL REGISTRATION


www.ANZCTR.org.au, CTRN12619000397112. Registered on 12 March 2019.",2020,A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group.,"['patients undergoing ERCPs', 'patients at risk of adverse respiratory events', 'high risk cases (OTHER', '132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group', 'Patients are often elderly with complex co-morbidities']","['low-flow and high-flow nasal cannulas (HFNC', 'oxygen supplementation through HFNC versus low-flow nasal cannula during ERCP', 'High-flow nasal cannula versus standard oxygen therapy assisting sedation', 'endoscopic retrograde cholangiopancreatography', 'Endoscopic retrograde cholangiopancreatography (ERCP', 'HFNC']","['rate of oxygen desaturation', 'parameters centred on oxygenation, requirement of airway manoeuvres, successful completion of procedure, perioperative complications, patient satisfaction and cost analysis of the consumables', 'proportion of patients experiencing hypoxia, defined by any event of SpO2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",132.0,0.173656,A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group.,"[{'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia. Venkatesan.Thiruvenkatarajan@sa.gov.au.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Dharmalingam', 'Affiliation': 'Department of Anaesthesia, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Arenas', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Wahba', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Vasanth Rao', 'Initials': 'VR', 'LastName': 'Kadam', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Currie', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Roelof', 'Initials': 'R', 'LastName': 'Van Wijk', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Quail', 'Affiliation': 'Human Physiology Anaesthesia and Intensive Care, School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Ludbrook', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}]",Trials,['10.1186/s13063-020-04378-z']
2883,32465052,Validation of CD4+ CD57+ PD1+ T Cells in Bronchoalveolar Lavage as a Biomarker of Lung Allograft Dysfunction.,"PURPOSE


Our analysis on serial bronchoalveolar lavage (BAL) cells from 25 lung transplant recipients (LTRs) using cutting-edge mass cytometry (MC) technology revealed a strong association between the frequency of CD4+ CD57+ PD1+ cells and subsequent lung allograft dysfunction (LAD). Here we present validation of this cell subset as a biomarker of incident LAD in an additional 25 LTRs.
METHODS


MC was performed using a panel of 37 heavy metal-tagged antibodies against surface markers and intracellular cytokines. This technique was applied to BAL cells from 50 consecutive LTRs at their 3-, 6- and 9-month post-transplant surveillance bronchoscopies. LTRs were randomly assigned into two groups (Fig 1A). Semi-supervised identification algorithm on the first group of LTRs identified CD4+ CD57+ PD1+ cells as the highest discriminatory cluster between stable and LAD patients. We then tested best-fit threshold for frequency of the cell subset and applied it on the second group of LTRs for validation.
RESULTS


Longitudinal analysis of the first randomized group of 25 LTRs demonstrated a higher frequency of CD4+ CD57+ PD1+ cells separating LAD (11.41±4.89%) from stable patients (4.43±2.11%; Fig 1B). Using a receiver operating characteristic curve, we identified a frequency of 7.8% as the best-fit threshold of the cell subset (Fig 1C). Survival analysis showed CD4+ CD57+ PD1+ T cells at 7.8% can discriminate stable from LAD patients in the first group of LTRs (Fig 1D). We then tested the performance of this threshold in the second group of LTRs and found those with BAL CD4+ CD57+ PD1+ cells above the threshold had significantly lower freedom from incident LAD (p=0.05, Fig 1E).
CONCLUSION


Our data validated that emergence of CD4+ CD57+ PD1+ T cells precedes allograft dysfunction in a small cohort of LTRs. Further validation in larger cohorts, and molecular and functional studies on this cell population are underway and may lead to improved prediction of LAD and a better understanding of lung transplant immunobiology.",2020,Survival analysis showed CD4+ CD57+ PD1+ T cells at 7.8% can discriminate stable from LAD patients in the first group of LTRs (Fig 1D).,['25 lung transplant recipients (LTRs) using cutting-edge mass cytometry'],"['CD4+ CD57+ PD1+ T cells', 'CD4+ CD57+ PD1+ T Cells', 'BAL CD4+ CD57+ PD1+ cells']","['serial bronchoalveolar lavage (BAL) cells', 'frequency of CD4+ CD57+ PD1+ cells and subsequent lung allograft dysfunction (LAD', 'frequency of CD4+ CD57+ PD1+ cells separating LAD', 'CD4+ CD57+ PD1+ T cells']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0054965', 'cui_str': 'Lymphocyte antigen CD57'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0054965', 'cui_str': 'Lymphocyte antigen CD57'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.0173248,Survival analysis showed CD4+ CD57+ PD1+ T cells at 7.8% can discriminate stable from LAD patients in the first group of LTRs (Fig 1D).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moshkelgosha', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Wilson', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martinue', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Juvet', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.805']
2884,32465073,The TEAMMATE Trial: Study Design and Rationale of the First Pediatric Heart Transplant Randomized Clinical Trial.,"PURPOSE


Currently there are no-FDA approved immunosuppressants specific to pediatric heart transplantation (HT). In recent years, everolimus (EVL) has emerged as an alternative to tacrolimus (TAC) as a primary immunosuppressant to prevent rejection that may also prevent kidney and coronary disease. However, the two regimens have never been evaluated systematically.
METHODS


The TEAMMATE Trial (IND 127980) is designed to evaluate the safety and efficacy of EVL and low-dose (LD-TAC) compared to standard-therapy TAC and mycophenolate mofetil (MMF). The study design and rationale are reviewed in light of challenges inherent in rare disease research.
RESULTS


The TEAMMATE trial is the first multicenter randomized clinical trial (RCT) in pediatric HT. The primary purpose is to evaluate the risk-benefit profile of the two regimens to prevent major adverse transplant events (MATE), and to support FDA approval of 1 or both regimens for pediatric HT. Children <21 years at HT will be randomized (1:1 ratio) at 6 mo. post-HT to either regimen for 30 months (Figure). Children with recurrent rejection or a GFR <60 ml/min/1.73m2 are excluded. The primary efficacy hypothesis is that compared to TAC/MMF, EVL/LD-TAC is more effective in preventing 3 MATEs: cellular rejection, CKD and CAV. The primary safety hypothesis is that EVL/LD-TAC does not have a higher cumulative burden of 6 MATE (AMR, infection, and PTLD + the 3 above). The primary endpoint is the MATE Score, a surrogate endpoint reflecting the frequency and severity of MATEs and validated against graft loss. The study will enroll 210 patients across 26 sites and is powered to demonstrate superior efficacy of EVL/LDTAC. The trial is projected to be completed in 2022.
CONCLUSION


The TEAMMATE trial is the first RCT in pediatric HT. It is anticipated that the study will provide important information about the safety and effectiveness of EVL and TAC and provide valuable lessons into the design and conduct of future trials in pediatric HT.",2020,"The primary efficacy hypothesis is that compared to TAC/MMF, EVL/LD-TAC is more effective in preventing 3 MATEs: cellular rejection, CKD and CAV.","['Children <21 years at HT', '210 patients across 26 sites', 'Children with recurrent rejection or a GFR <60 ml/min/1.73m2 are excluded']","['EVL and low-dose (LD-TAC', 'EVL/LDTAC', 'everolimus (EVL', 'EVL/LD-TAC', 'mycophenolate mofetil (MMF', 'TAC/MMF, EVL/LD-TAC', 'tacrolimus (TAC']","['MATE Score, a surrogate endpoint reflecting the frequency and severity of MATEs and validated against graft loss']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162488', 'cui_str': 'Surrogate Endpoint'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}]",,0.0645756,"The primary efficacy hypothesis is that compared to TAC/MMF, EVL/LD-TAC is more effective in preventing 3 MATEs: cellular rejection, CKD and CAV.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Almond', 'Affiliation': 'Pediatric Cardiology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Rossano', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Lal', 'Affiliation': ""U of Utah Primary Children's Hospital, Salt Lake City, UT.""}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Castleberry', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Palo Alto, CA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hollander', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': ""Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Barkoff', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Palo Alto, CA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fenton', 'Affiliation': 'Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Daly', 'Affiliation': ""Children's Hospital Boston, Boston, MA.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.825']
2885,32465077,Health-Related Quality of Life Differs by Pre-Operative Implant Strategy from before through Mid-Term after Surgery: Findings from INTERMACS.,"PURPOSE


Little information exists on change in health-related quality of life (HRQOL) over time by left ventricular assist device (LVAD) implant strategy. The purpose of this study was to examine HRQOL by pre-operative implant strategy from pre-implant to 1 and 2 years after surgery.
METHODS


Data were collected from mostly male, ≥ 50 years old, not working patients (pts) in the INTERMACS database who were stratified into 3 groups based on implant strategy: destination therapy (DT) (n=2901), bridge to transplant (BTT) (n=2209), and bridge to candidacy (BTC) (n=3076). HRQOL data were collected before and 1 and 2 years after surgery using the generic EQ-5D-3L visual analog scale (VAS) and heart failure-specific KCCQ-12 summary score (SS); higher scores=better HRQOL. General linear random effects models were used to examine whether HRQOL changed from pre-implant to 1 and 2 years post-implant by implant strategy.
RESULTS


Regarding VAS modeling, a significant main effect of time (p<0.001) and a group by time interaction (p=0.01) were detected. No group differences emerged at baseline and year 1; at year 2, the BTT group had a higher VAS score than the BTC and DT groups (p<0.05). Regarding the group by time interaction, all groups improved significantly (p<0.001) from baseline to year 1 and baseline to year 2, while from year 1 to year 2, the BTT group improved (p=0.04) and the DT group declined (p<0.001). For the KCCQ-12 SS, a significant main effect of time (p<0.001) and a group by time interaction (p=0.04) emerged. At baseline, the BTT group had a higher KCCQ-12 SS than the DT and BTC groups (p<0.05) while there were no group differences at year 1 or year 2. Regarding the group by time interaction, all groups improved significantly (p<0.001) from baseline to year 1 and baseline to year 2. From year 1 to year 2, there was no significant change for the BTT group; the BTC and DT groups significantly declined (p= 0.04 and <0.01, respectively). Follow-up analyses stratified by age group (<50 vs. ≥50) showed that the group by time interactions for both measures were driven by the 50+ age group.
CONCLUSION


Overall HRQOL improved across all 3 implant strategy groups from pre implant to 2 years post implant. Subtle declines emerged for DT pts from 1 to 2 years. These findings may assist clinicians with HRQOL-related interventions from before to mid-term after implant.",2020,"At baseline, the BTT group had a higher KCCQ-12 SS than the DT and BTC groups (p<0.05) while there were no group differences at year 1 or year 2.","['Data were collected from mostly male, ≥ 50 years old, not working patients (pts) in the INTERMACS database who were stratified into 3 groups based on']","['implant strategy: destination therapy (DT) (n=2901), bridge to transplant (BTT) (n=2209), and bridge to candidacy (BTC']","['VAS score', 'health-related quality of life (HRQOL', 'HRQOL data', 'Overall HRQOL', 'Health-Related Quality of Life', 'generic EQ-5D-3L visual analog scale (VAS) and heart failure-specific KCCQ-12 summary score (SS); higher scores=better HRQOL']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0464674,"At baseline, the BTT group had a higher KCCQ-12 SS than the DT and BTC groups (p<0.05) while there were no group differences at year 1 or year 2.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'White-Williams', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fazeli', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Kirklin', 'Affiliation': 'Kirklin Institute for Research in Surgical Outcomes (KIRSO), University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Northwestern Mem Hosp, Arlington Heights, IL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.826']
2886,32465125,Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients - 3-year Results from the HITTS Randomized Controlled Trial.,"OF OBJECTIVES


The HITTS study (High -intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia) is a randomized controlled trial designed to assess the effect of high-intensity interval training (HIT) versus moderate intensity continuous training (MICT) on exercise capacity in de novo heart transplant recipients. The primary endpoint was the change in oxygen consumption (VO 2peak ) at the end of the intervention period, which began 3 months after heart transplantation (HTx). After the 9-month long intervention period, we reported a between-group difference in VO 2peak  of 1.8 ml/kg/min in favor of HIT (p = 0.04).We found that HIT was safe, well tolerated and efficient. The HITTS study is the first randomized controlled trial to assess the effectiveness of HIT in de novo heart transplant recipients. However, long-term effects of commencing HIT soon after HTx remain unknown. In this extension of the HITTS trial, our aim was to examine whether the benefits of 9 months of supervised HIT training persist two years after the end of the intervention.
METHODS


In the HITTS study, we randomized 81 adult de novo heart transplant recipients to 9 months of HIT (4 × 4 min intervals at 85-95% of peak heart rate (HR) or 9 months of MICT (60-80% of peak HR). The mean ± SD age was 49 ±13 and 73 % were men. Before the start of the intervention and at follow-up shortly after the intervention, we measured VO 2peak , isokinetic muscle strength, body composition, left ventricular function by echo, biomarkers, and health-related quality of life (HRQoL). For the extension study, the measurements will be repeated 3 years after enrollment. VO 2peak  is measured with breath-by-breath gas exchange on a treadmill or bicycle ergometer. The last patient is scheduled to complete his/her 3-year follow-up at Nov 14 th , 2019. Data will be available for presentation at ISHLT 2020.
ENDPOINTS


The primary outcome is the long-term effect of HIT vs MICT on aerobic exercise capacity as assessed by VO 2peak . Secondary outcomes are: Isokinetic muscular strength in the lower limbs by a dynamometer, body composition (bio-impedance analysis), left ventricular function by echo, heart rate response during the cardiopulmonary exercise test, relevant circulation biomarkers (renal function, NT-proBNP and cardiac troponins), HRQoL, tolerability, safety and adverse events.",2020,"The primary endpoint was the change in oxygen consumption (VO 2peak ) at the end of the intervention period, which began 3 months after heart transplantation (HTx).","['81 adult de novo heart transplant recipients to 9 months of HIT (4\u202f×\u202f4 min intervals at 85-95% of peak heart rate (HR) or 9 months of MICT (60-80% of peak HR', 'de novo Heart Transplant Recipients in Scandinavia', 'The mean ± SD age was 49 ±13 and 73 % were men', 'de novo heart transplant recipients', 'De Novo Heart Transplant Recipients - 3-year']","['Interval Training', 'high-intensity interval training (HIT) versus moderate intensity continuous training (MICT', 'supervised HIT training', 'High-Intensity Interval Training']","['change in oxygen consumption (VO 2peak ', 'VO 2peak', 'exercise capacity', 'safe, well tolerated and efficient', 'VO 2peak , isokinetic muscle strength, body composition, left ventricular function by echo, biomarkers, and health-related quality of life (HRQoL', 'long-term effect of HIT vs MICT on aerobic exercise capacity as assessed by VO 2peak ', 'Isokinetic muscular strength in the lower limbs by a dynamometer, body composition (bio-impedance analysis), left ventricular function by echo, heart rate response during the cardiopulmonary exercise test, relevant circulation biomarkers (renal function, NT-proBNP and cardiac troponins), HRQoL, tolerability, safety and adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023983', 'cui_str': 'Effects, Longterm'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",81.0,0.134679,"The primary endpoint was the change in oxygen consumption (VO 2peak ) at the end of the intervention period, which began 3 months after heart transplantation (HTx).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.870']
2887,32465366,Point of Care Management of Perioperative Coagulopathy Reduces Consumption of Fresh Frozen Plasma and Seems to Be Associated with Decreased Apache and Sofa Scores in Patients Undergoing Lung Transplantation (Preliminary Results).,"PURPOSE


Lung transplantation is often accompanied with significant bleeding and coagulopathy. Perioperative management usually consists of administering of fresh frozen plasma (FFP) and red blood cells. However, usage of blood transfusion products, especially FFP, may be associated with higher morbidity of patient. Point of care (POC) monitoring of coagulopathy by thrombelastometry (ROTEM), platelet function analyzer (PFA 200) and agregometer (Multiplate) and subsequent aimed therapy may lead to decreased consumption of FFP. The purpose of this study is to investigate if POC based monitoring and treatment of coagulopathy may decrease consumption of FFP, APACHE II (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores.
METHODS


Patients undergoing bilateral lung transplantation were randomized into 2 groups. In the first group (non-POC group) management of bleeding and coagulopathy was based on anesthesiologist´s experience by administering FFP or other coagulation factors. In the second group (POC group) management of coagulopathy was based on results of POC methods such as ROTEM, PFA 200, Multiplate and 5% albumin solution was used to maintain normovolemia.
RESULTS


Total number of analyzed patients is 46. In POC group no FFP unit was used at all. Admission APACHE II score as well as SOFA score 24 hours after admission was significantly decreased in POC group of patients (p<0.05). Results are shown on Figure.
CONCLUSION


Perioperative usage of POC methods such as ROTEM, PFA 200 and Multiplate to diagnose and treat coagulopathy significantly reduces consumption of FFP and may decrease APACHE II and SOFA score in patients undergoing lung transplantation. The study is registered in clinical trial database with number: CTN03598907.",2020,Admission APACHE II score as well as SOFA score 24 hours after admission was significantly decreased in POC group of patients (p<0.05).,"['Patients Undergoing Lung Transplantation (Preliminary Results', 'patients undergoing lung transplantation', 'Patients undergoing bilateral lung transplantation']","['care (POC', 'fresh frozen plasma (FFP) and red blood cells']","['FFP, APACHE II (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores', 'Admission APACHE II score as well as SOFA score 24 hours after admission', 'APACHE II and SOFA score', 'bleeding and coagulopathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0396599', 'cui_str': 'Double lung transplant'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]","[{'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}]",,0.0234617,Admission APACHE II score as well as SOFA score 24 hours after admission was significantly decreased in POC group of patients (p<0.05).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Durila', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vajter', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lischke', 'Affiliation': '3rd Department of Surgery, 1st Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berousek', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vymazal', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.694']
2888,32465368,Effects of Donor Smoking History on Early Post-Transplant Lung Function Measured by Oscillometry.,"PURPOSE


Oscillometry (Osc) is a non-invasive test of respiratory impedance that is sensitive to small airways, a region of lung that is not well characterized by conventional pulmonary function tests (PFT) and has been shown to detect chronic obstructive lung disease (COPD) prior to changes in PFT. We posit that Osc could identify small airway obstruction post-lung transplant (LTx) and discriminate between lungs from smoking vs non-smoking donors.
METHODS


All double LTx recipients who consented to the study were prospectively tested with Osc prior to PFT during post-LTx clinic follow-up. Osc was conducted according to ERS criteria. Mann-Whitney U test was used to compare Osc and PFT parameters of recipients of non-smoking vs. smoking donor lungs.
RESULTS


From December 2017 to July 2019, 179 patients were enrolled, of whom 102 received lungs from donors with a smoking history (27 had ≥20 pack years) and 68 received lungs from non-smokers. We excluded 33 patients with insufficient data on donor smoking history. No differences were observed between smoking and non-smoking donor groups overall. However, in patients who received donor lungs with ≥20 pack years, Osc identified small airway obstruction 8 weeks post LTx. The main Osc parameters of small airway obstruction, A x  (area of reactance) and X 5  (reactance at 5 Hz) were significantly different between the 2 groups. The R 5-19  (difference between resistance at 5 and 19 Hz), a measure of small airway obstruction, was increased in smokers, but the difference was not significant. Differences in PFT were not significant (Table 1).
CONCLUSION


Recipients of lungs from donors with a significant smoking history had evidence of small airway obstruction as detected by Osc. Differences in Osc measurements were not detected for donors with a <20 pack year smoking history, suggesting that a moderate smoking history is unlikely to affect post-LTx lung function. Longer follow-up is needed to determine whether the observed differences persist over time and lead to graft dysfunction.",2020,No differences were observed between smoking and non-smoking donor groups overall.,"['recipients of non-smoking vs. smoking donor lungs', '179 patients were enrolled, of whom 102 received lungs from donors with a smoking history (27 had ≥20 pack years) and 68 received lungs from non-smokers', 'From December 2017 to July 2019', '33 patients with insufficient data on donor smoking history', 'All double LTx recipients who consented to the study were prospectively tested with Osc prior to PFT during post-LTx clinic follow-up']",[],"['Early Post-Transplant Lung Function', 'small airway obstruction', 'small airway obstruction, A x  (area of reactance) and X 5  (reactance at 5 Hz']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0524360', 'cui_str': 'Donor for lung transplant'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",33.0,0.0197869,No differences were observed between smoking and non-smoking donor groups overall.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Belousova', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Biostatistics Research Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'deHaas', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vasileva', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Q W', 'Initials': 'QW', 'LastName': 'Huang', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nadj', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Singer', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ghany', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martinu', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tikkanen', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Toronto Lung Transplant Programme, University Health Network, Toronto, ON, Canada.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.695']
2889,32465374,Diagnostic Yield of Transbronchial Cryobiopsies for the Diagnosis of Rejection in Lung Transplant Patients.,"PURPOSE


Transbronchial biopsy (TBB) using forceps is the standard procedure to establish the presence of allograft rejection after lung transplantation. However, inadequate tissue samples, high degree of interobservers variability and possible complications seems to prevent many centers in scheduling TBB in lung transplant follow-up. Despite transbronchial cryobiopsies (TCB) yield large specimens, few studies addressed the use of this technique. We aimed to analyze the diagnostic yield and complications rate of TCB in a surveillance program for lung transplant patients.
METHODS


This is a retrospective comparative study with historical control. Eligible for inclusion were adults subjected to scheduled transbronchial biopsy at 3, 6 and 12 months after lung transplantation. A single pathologist classified the biopsy according to ISHLT scale.
RESULTS


From 2018, 54 consecutive patients underwent TCB; previous 110 consecutive patients underwent TBB. The study group received 75 procedures versus 223 in the historical group. The diagnostic yield for acute rejection of TCB and TBB were 100% and 83%, respectively (p < 0.001). The diagnostic yield for chronic rejection of TCB and TBB were 85% and 64%, respectively. We did not record mortality in either group, while the complication rate was 9% in the study group and 5% in the historical group. Moderate bleeding rate of TCB and TBB were 8% and 1%, respectively. None of the patients required blood transfusion.
CONCLUSION


TCB showed high diagnostic yield in a surveillance program for lung transplant patients; despite the low clinical impact, the complication rate is not negligible. These good results have led us to implement an interventional crossover trial on TCB versus TBB.",2020,"The diagnostic yield for acute rejection of TCB and TBB were 100% and 83%, respectively (p < 0.001).","['Eligible for inclusion were adults subjected to scheduled transbronchial biopsy at 3, 6 and 12 months after lung transplantation', '54 consecutive patients underwent TCB; previous 110 consecutive patients underwent TBB', 'Lung Transplant Patients', 'lung transplant patients']","['Transbronchial biopsy (TBB', 'TCB']","['Moderate bleeding rate of TCB and TBB', 'complication rate']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",54.0,0.0174845,"The diagnostic yield for acute rejection of TCB and TBB were 100% and 83%, respectively (p < 0.001).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rosso', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shehab', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tosi', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Righi', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Carrinola', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': ""Pathology Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vaira', 'Affiliation': 'Pathology Department, University of Milan, Milan, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mendogni', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Palleschi', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Morlacchi', 'Affiliation': ""Department of Pneumology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nosotti', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.698']
2890,32465383,Formal Pulmonary Rehabilitation after Lung Transplantation Improves Six Minute Walk Distance.,"PURPOSE


We hypothesized that an intensive PR program after LT would improve 6-minute walk distance (6MWD) more than a conventional PR program.
METHODS


78 consecutive LT recipients who survived >90 days were included. The intensive group (n=48) was prescribed supervised PR 5 days/wk for 10 wks. The conventional group (n=30) was prescribed supervised PR 3 days/wk for 8 wks with additional self-exercise on non-PR days for a total of 10 wks. Both groups completed 6MWD, Patient Health Questionnare-9 (PHQ-9), and Rating of Perceived Dyspnea (RPD) assessments on their initial and final visits. The primary outcome was change in 6MWD. Secondary outcomes were days required to achieve 30 min of continuous exercise and changes in PHQ-9 and RPD scores. Changes in 6MWD, PHQ-9, and RPD were assessed by paired Wilcoxon signed rank testing. Multivariable linear regression was used to control for age, type of LT, indication, and lung allocation score (LAS).
RESULTS


The intensive PR group completed 42 supervised visits while the conventional group completed 24 supervised and 12 unmonitored visits (p<0.001 for supervised PR visits). The 6MWD significantly increased in both groups (p=<0.001): 680 ft (65%) in the intensive PR group and 515 ft (53%) in the conventional PR group (p<0.037). The median number of days needed to achieve 30 min of continuous exercise was 8 visits in the intensive group and 13 visits in the conventional group (p<0.001). PHQ-9 and RPD showed improvement in both groups. After controlling for age, LAS, indication for LT, and type of LT, patients in the intensive PR group significantly increased 6MWD more than the conventional group (median +231 ft, 95%CI 32-431 ft, p=0.023) (Figure).
CONCLUSION


Formal PR after LT significantly improved 6MWD, PHQ-9, and RPD scores. Intensive PR achieved a clinically significantly greater improvement in 6MWD and required fewer PR visits to achieve 30 min of continuous exercise.",2020,The 6MWD significantly increased in both groups (p=<0.001): 680 ft (65%) in the intensive PR group and 515 ft (53%) in the conventional PR group (p<0.037).,['78 consecutive LT recipients who survived >90 days were included'],[],"['6MWD, PHQ-9, and RPD scores', 'median number of days needed to achieve 30 min of continuous exercise', 'PHQ-9 and RPD', '6MWD, PHQ-9, and RPD', '6MWD', 'change in 6MWD', '6MWD, Patient Health Questionnare-9 (PHQ-9), and Rating of Perceived Dyspnea (RPD) assessments on their initial and final visits', '6-minute walk distance (6MWD', 'days required to achieve 30 min of continuous exercise and changes in PHQ-9 and RPD scores']","[{'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",78.0,0.041967,The 6MWD significantly increased in both groups (p=<0.001): 680 ft (65%) in the intensive PR group and 515 ft (53%) in the conventional PR group (p<0.037).,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mwizerwa', 'Affiliation': 'Lung Transplant, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Shaver', 'Affiliation': 'Lung Transplant, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McNatt', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Robbins', 'Affiliation': 'Lung Transplant, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Norfolk', 'Affiliation': 'Lung Transplant, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McCloskey', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.708']
2891,32465479,Management of Heart Failure in Left Ventricular Assist Device (LVAD) Patients Utilizing an Outpatient Diuresis Clinic.,"PURPOSE


Left ventricular assist device (LVAD) implantation and survival is increasing. With patients living longer on device support, LVAD-related healthcare costs and hospitalizations, including those for volume overload, are on the rise as well. The Johns Hopkins Heart Failure Bridge Clinic (HFBC), a HF-trained Nurse Practitioner (NP) led clinic with ability to administer outpatient intravenous (IV) diuretics, has resulted in significant reductions in HF readmission rates. We developed a protocol for LVAD patient assessment and management via the HFBC, and describe our initial experience regarding the role and efficacy of this unique program in outpatient management of HF in LVAD patients.
METHODS


LVAD patients were evaluated by an LVAD provider and subsequently referred to the diuresis clinic for volume overload thought not to be related to an LVAD issue. If seen in the diuresis clinic, patients then had repeat evaluation with the LVAD/HF team within one week. Baseline characteristics and HF outcomes were assessed.
RESULTS


Nineteen LVAD patients were seen in the diuresis clinic a total of 65 times. IV furosemide was administered 31 times to 13 patients (mean dose 80 ± 23.5 mg). Urine output during first in clinic void after IV diuretic was 125 ± 53 mL. At 30 of 65 (46%) visits, oral diuretic dose was uptitrated. Potassium was given at 18 of the 65 (27.7%) visits. There were no significant changes in blood pressure, renal function, or electrolytes post diuresis. Only 1 of 65 patient visits resulted in direct hospital admission (hyponatremia). All other visits discharged to home in improved/stable condition and avoidance of hospitalization for heart failure. During follow up, only 6 of 19 patients were hospitalized for a primary diagnosis of volume overload.
CONCLUSION


We describe successful implementation of an outpatient IV diuresis protocol for treatment of HF in LVAD patients. The strategy has major implications in reducing LVAD-related HF hospitalizations and healthcare utilization.",2020,"There were no significant changes in blood pressure, renal function, or electrolytes post diuresis.","['LVAD patients', 'Nineteen LVAD patients', 'LVAD patients were evaluated by an LVAD provider and subsequently referred to the diuresis clinic for volume overload thought not to be related to an LVAD issue', 'Patients Utilizing an Outpatient Diuresis Clinic', '19 patients were hospitalized for a primary diagnosis of volume overload']","['Potassium', 'Left Ventricular Assist Device (LVAD', 'IV furosemide']","['direct hospital admission (hyponatremia', 'Urine output', 'HF readmission rates', 'diuresis clinic', 'blood pressure, renal function, or electrolytes post diuresis', 'stable condition and avoidance of hospitalization for heart failure']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.054986,"There were no significant changes in blood pressure, renal function, or electrolytes post diuresis.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Freed', 'Affiliation': 'Cardiac Surgery, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cuomo', 'Affiliation': 'Cardiology, Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': 'Cardiology, Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Cardiology, Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Menzel', 'Affiliation': 'Cardiology, Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Florido', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Cardiac Surgery, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Cardiac Surgery, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Umapathi', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fioretti', 'Affiliation': 'Cardiac Surgery, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Klemans', 'Affiliation': 'Cardiac Surgery, Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gilotra', 'Affiliation': 'Cardiology, Johns Hopkins Hospital, Baltimore, MD.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.400']
2892,32465510,Surface Antigens on Plasma Extracellular Vesicles of Cystic Fibrosis Patients Treated by Extracorporeal Photopheresis as Induction Therapy after Lung Transplantation: Preliminary Results of a Pilot Randomized Trial.,"PURPOSE


Acute rejection (AR) is common during the first year after lung transplantation (LuTx) and can trigger chronic rejection (CR), the leading cause of late morbidity and mortality of LuTx. Extracorporeal photopheresis (ECP) is a promising treatment for chronic rejection. Few studies focus on ECP as prophylactic therapy of AR and CR. Microvesicles and exosomes (i.e.extracellular vesicles EV) are released into the blood and in bronchoalveolar lavage (BAL) and their role in cell-to-cell communication has been assessed in several studies; EV have been proposed as non-invasive biomarkers to assess lung injury and monitor clinical outcome.
METHODS


We conduct a pilot clinical trial on 24 cystic fibrosis patients undergoing LuTx, randomly allocated in 2 parallel arms: standard immunosuppressive therapy and ECP (ECP) vs standard immunosuppressive therapy alone (CTR). EV concentration was assessed at different time points in blood and BAL in the first year after LuTx (analyzed by nanoparticle tracking analysis Nanosight NS300, Malvern). EV were analyzed for antigen expression with MACSplex bead-based assay. AR episodes and infections were recorded, as far as ECP-related adverse events. Preliminary data on the first 18 patients (9 ECP and 9 CTR) are reported RESULTS: ECP was well tollerated and no adverse events or AR occurred in either groups. EV presented highly polydispersed size distributions in a 50-1000 nm range. The expression of EV-associated markers CD63, CD9 and CD81 was detected. Upregulation of platelets (CD62p; p<0.05 by t-test), lymphocytes (CD3, CD24) markers and integrins (CD29, CD49e) was observed in ECP-treated patient compared to the control group.
CONCLUSION


The underlying mechanism of ECP remains unresolved. The identification of specific EV antigen signatures may represent a promising approach to better understand the immunomodulatory effects of ECP, both at molecular and cellular level.",2020,"Upregulation of platelets (CD62p; p<0.05 by t-test), lymphocytes (CD3, CD24) markers and integrins (CD29, CD49e) was observed in ECP-treated patient compared to the control group.
","['24 cystic fibrosis patients undergoing LuTx, randomly allocated in 2 parallel arms', 'Cystic Fibrosis Patients Treated by Extracorporeal Photopheresis as Induction Therapy after Lung Transplantation']","['standard immunosuppressive therapy and ECP (ECP) vs standard immunosuppressive therapy alone (CTR', 'ECP', 'Extracorporeal photopheresis (ECP']","['expression of EV-associated markers CD63, CD9 and CD81', 'lymphocytes (CD3, CD24) markers and integrins (CD29, CD49e', 'tollerated and no adverse events or AR', 'AR episodes and infections', 'EV concentration']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0206373', 'cui_str': 'Extracorporeal photopheresis'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0206373', 'cui_str': 'Extracorporeal photopheresis'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0083298', 'cui_str': 'Lymphocyte antigen CD63'}, {'cui': 'C0054970', 'cui_str': 'Lymphocyte antigen CD9'}, {'cui': 'C0084715', 'cui_str': 'Lymphocyte antigen CD81'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0054948', 'cui_str': 'Lymphocyte antigen CD24'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0081938', 'cui_str': 'Cluster of differentiation antigen 29'}, {'cui': 'C0298340', 'cui_str': 'Lymphocyte antigen CD49E'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.0300821,"Upregulation of platelets (CD62p; p<0.05 by t-test), lymphocytes (CD3, CD24) markers and integrins (CD29, CD49e) was observed in ECP-treated patient compared to the control group.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rosso', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Righi', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barilani', 'Affiliation': ""Laboratory of Regenerative Medicine - Cell Factory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Buono', 'Affiliation': ""Laboratory of Regenerative Medicine - Cell Factory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Damarco', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Trabattoni', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Diotti', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nosotti', 'Affiliation': ""Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mocellin', 'Affiliation': 'Department of Transfusion Medicine and Hematology, Fondazione IRCCS Ca Granda, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lazzari', 'Affiliation': ""Laboratory of Regenerative Medicine - Cell Factory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.428']
2893,32465573,Generalizability of Left Ventricular Assist Device Clinical Trial Findings: An Analysis of the INTERMACS Database.,"PURPOSE


Clinical trials assessing durable LVAD therapy have demonstrated survival benefits that have increased adoption. However, highly selected trial populations may not reflect the real-world setting. We assessed the generalizability of LVAD clinical trial findings by comparing mortality between LVAD recipients meeting current trial eligibility criteria to those ineligible.
METHODS


Patients undergoing LVAD implantation between 2012-2017 were identified in INTERMACS (n=15,077). MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy with HeartMate 3) trial inclusion/exclusion criteria were mapped to INTERMACS variables to categorize patients as trial eligible or ineligible and by number of exclusion criteria present: 0, 1, 2, and ≥3. Kaplan-Meier analyses were used to compare cumulative mortality by trial eligibility and number of exclusion criteria. Multivariable Cox models were used to report risk-adjusted mortality with hazard ratios (HR) and 95% confidence intervals (CI).
RESULTS


A total of 6728 (44.6%) LVAD recipients were trial ineligible, of which 4331 (28.7%) had 1 exclusion, 1517 (10.1%) had 2, and 880 (5.8%) had ≥3. Mortality for trial ineligible recipients (1-year: 26±1%; 3-year: 44±2%) was higher than for trial eligible recipients (1-year: 16±1%; 3-year: 37±1%; p<0.001, Fig. A). Number of exclusion criteria per patient was directly associated with mortality (p<0.001, Fig. B). Trial ineligibility was independently associated with mortality (HR 1.29 [CI 1.21-1.37], p<0.001), while an increased number of exclusion criteria conferred increased mortality risk (1: HR 1.15 [CI 1.07-1.23]; 2: HR 1.49 [CI 1.35-1.64]; ≥3: HR 2.13 [CI 1.89-2.40]; all p<0.001).
CONCLUSION


Nearly half of real-world LVAD recipients do not meet current clinical trial criteria, and these trial ineligible recipients demonstrated higher mortality. Providers should incorporate trial criteria when assessing LVAD candidate outcomes.",2020,"Number of exclusion criteria per patient was directly associated with mortality (p<0.001, Fig. B).","['trial ineligible recipients (1-year: 26±1%; 3-year: 44±2%) was higher than for trial eligible recipients (1-year: 16±1', 'LVAD recipients were trial ineligible, of which 4331 (28.7%) had 1 exclusion, 1517 (10.1%) had 2, and 880 (5.8%) had ≥3', 'Patients Undergoing Mechanical Circulatory Therapy with HeartMate 3) trial inclusion/exclusion criteria were mapped to INTERMACS variables to categorize patients as trial eligible or ineligible and by number of exclusion criteria present: 0, 1, 2, and ≥3', 'Patients undergoing LVAD implantation between 2012-2017 were identified in INTERMACS (n=15,077', 'A total of 6728 (44.6', 'LVAD recipients meeting current trial eligibility criteria to those ineligible']",['MagLev Technology'],"['mortality', 'mortality risk', 'Mortality', 'cumulative mortality']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.490195,"Number of exclusion criteria per patient was directly associated with mortality (p<0.001, Fig. B).","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Brescia', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Watt', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Pagani', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Cascino', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'McCullough', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shore', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Likosky', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Aaronson', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Thompson', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1198']
2894,32465631,Short Term Retention of Ventricular Assist Device Self-Care Skills after Simulation-Based Mastery Learning.,"PURPOSE


Patients implanted with a ventricular assist device (VAD) and their caregivers must learn self-care skills to help prevent complications. We created a VAD self-care simulation-based mastery learning (SBML) curriculum and evaluated the retention of VAD self-care skills between SBML and traditionally-trained patients and caregivers.
METHODS


From June 2017 to February 2019, patients and their caregivers at a tertiary care VAD center were randomized to SBML or traditional-training during their implant hospitalization. SBML consisted of participants taking a pretest on 3 VAD self-care skills (controller, power source, and driveline dressing changes), watching videos, and performing deliberate practice on a VAD simulator. SBML participants took the 3 skills tests again before discharge and were required to meet or exceed a minimum passing score for each skill. The traditionally-trained group received the existing institutional VAD self-care teaching and took the 3 VAD self-care skills tests before discharge. Subsequently, the SBML group was retested at 1 and 3 months after discharge and the traditionally-trained group was retested 3 months after discharge.
RESULTS


15 patients and 15 caregivers in the SBML group and 16 patients and 16 caregivers in the traditionally-trained group completed the study (Table). There were no differences in demographic and clinical information between groups. There were no significant differences between discharge test performance and 1 and 3 month follow-up performance within the SBML group. The SBML group significantly outperformed the traditionally-trained group at 3 months on all 3 skills tests (all p <0.05).
CONCLUSION


VAD self-care SBML resulted in skills retention up to 3 months after discharge. Traditional VAD training resulted in sustained low levels of VAD self-care skills that did not improve after living with a VAD for 3 months. SBML is an effective method to train patients and caregivers on VAD self-care skills.",2020,There were no significant differences between discharge test performance and 1 and 3 month follow-up performance within the SBML group.,"['From June 2017 to February 2019, patients and their caregivers at a tertiary care VAD center', 'SBML and traditionally-trained patients and caregivers', '15 patients and 15 caregivers in the SBML group and 16 patients and 16 caregivers in the traditionally-trained group completed the study (Table']","['SBML', 'Traditional VAD training', 'VAD self-care simulation-based mastery learning (SBML) curriculum', 'existing institutional VAD self-care teaching', 'SBML or traditional-training', 'ventricular assist device (VAD']","['sustained low levels of VAD self-care skills', 'skills retention', 'discharge test performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0450646,There were no significant differences between discharge test performance and 1 and 3 month follow-up performance within the SBML group.,"[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Barsuk', 'Affiliation': 'Medicine/Medical Education, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Cohen', 'Affiliation': 'Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wilcox', 'Affiliation': 'Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Harap', 'Affiliation': 'Surgery, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Shanklin', 'Affiliation': 'Surgery, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Medicine/Medical Education, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Surgery/Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': 'Medicine/Medical Education, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1203']
2895,32465722,Elevated Serum C-reactive Protein (CRP) Level Predicts Increased Post-Implant Mortality in Patients Undergoing HeartMate 3 LVAD Implantation.,"PURPOSE


C-reactive protein (CRP) emerged as a biomarker of inflammation in heart failure patients and associated with increased morbidity and mortality. We hypothesized that higher serum CRP level prior to Heartmate 3 LVAD implantation is associated with increased risk of post-implant adverse events and mortality.
METHODS


123 patients who underwent Heartmate 3 LVAD implantation at a tertiary care center and had a CRP level measured prior to device implant were included in the analysis. Optimal CRP cut-off was determined used ROC curve and patients were categorized into high vs. low CRP groups accordingly. Study end-points included RVAD use, need for CVVH, in-hospital mortality, and 2-year survival.
RESULTS


Mean and median pre-implant CRP levels in HM3 patients were 35.5±43.6 mg/L and 15.0 mg/L respectively. Patients with an elevated pre-implant CRP (≥12 mg/L) were more likely to be in INTERMACS Class I or II (78.4% vs. 46.6%), to have temporary MCS (49.2% vs. 27.5%), and elevated WBC count (9.1 vs. 7.5) compared to those with a pre-implant CRP less than 12 mg/L (all p <0.05). High CRP group had significantly higher RVAD use (32.3% vs. 15.5%, p=0.030), need for CVVHD (13.8% vs. 3.4%), and in-hospital mortality (14.0% vs. 1.8%, p=0.028). Patients with elevated pre-implant CRP had significantly lower survival compared to those with lower pre-implant CRP (74.2% vs. %96.1, log-rank p =0.020) and a trend-towards lower freedom from post-implant stroke (%89.2 vs. %98.3, log-rank p =0.072) at 2-year follow-up (Figure). After adjustment for age, ischemic etiology, creatinine, bilirubin, albumin, and INTERMACS Class, high CRP (≥ 12 mg/L) remained as an independent predictor of survival on LVAD support (HR 3.81 [1.35 - 10.75], p=0.011).
CONCLUSION


Pre-implant CRP is a strong predictor of morbidity and mortality in patients undergoing HM3 implantation. Routine assessment of CRP prior to implant may improve patient selection and outcomes in this population.",2020,"High CRP group had significantly higher RVAD use (32.3% vs. 15.5%, p=0.030), need for CVVHD (13.8% vs. 3.4%), and in-hospital mortality (14.0% vs. 1.8%, p=0.028).","['heart failure patients', 'patients undergoing HM3 implantation', '123 patients who underwent Heartmate 3 LVAD implantation at a tertiary care center and had a CRP level measured prior to device implant were included in the analysis', 'Patients Undergoing HeartMate 3 LVAD Implantation']",[],"['elevated WBC count', 'serum CRP level', 'need for CVVHD', 'Mean and median pre-implant CRP levels', 'survival', 'Elevated Serum C-reactive Protein (CRP) Level', 'RVAD use', 'hospital mortality', 'temporary MCS', 'morbidity and mortality', 'RVAD use, need for CVVH, in-hospital mortality, and 2-year survival']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0472681', 'cui_str': 'Continuous venovenous hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}]",123.0,0.0416776,"High CRP group had significantly higher RVAD use (32.3% vs. 15.5%, p=0.030), need for CVVHD (13.8% vs. 3.4%), and in-hospital mortality (14.0% vs. 1.8%, p=0.028).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Batra', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jennings', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Truby', 'Affiliation': 'Medicine, Duke University, Durham, NC.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'DeFilippis', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malick', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Masoumi', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Clerkin', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raikhelkar', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fried', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yuzefpolskaya', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Colombo', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sayer', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farr', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Topkara', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.228']
2896,32465725,Outcomes in Patients with Small Body Surface Area after HeartMate 3 (HM3) Left Ventricular Assist Device (LVAD) Implantation.,"PURPOSE


Outcomes of patients with small body size following HM3 LVAD implantation have not been well characterized. We sought to compare preoperative characteristics and clinical outcomes among patients stratified by body surface area.
METHODS


Patients who received a HeartMate 3 LVAD at our institution between October 1, 2015 and June 30, 2019 were analyzed. Patients who received a HM3 LVAD as pump exchange were excluded. The cohort was divided in 4 groups: BSA ≤1.8 m 2  (group 1), BSA >1.8 - ≤2.0 m 2  (group 2), BSA >2.0 - ≤2.2 m 2  (group 3) and BSA >2.2 (group 4).
RESULTS


One hundred and nineteen patients were included in this analysis. Preoperative characteristics and postoperative results of each group are shown in Table 1. Group 1 patients were older and mostly females. A history of diabetes was less common in this group. Mean postoperative length of stay was similar between groups. Pump speed at the time of discharge was lower in group 1 patients. Mean follow-up was similar between groups. Mean days out of the hospital after discharge did not differ among the groups. One-year survival was 93% for group 1, 85% for group 2, 86% for group 3 and 84% for group 4 (p=0.69). Kaplan Meier survival curves are shown in Figure 1 (log rank: 0.692).
CONCLUSION


Outcomes following HM3 LVAD implantation were comparable between patients with small body surface area and patients with larger body size. Small body size should not be an exclusion criteria for HM3 LVAD implantation in patients with advanced heart failure who are otherwise candidates for durable mechanical support.",2020,"One-year survival was 93% for group 1, 85% for group 2, 86% for group 3 and 84% for group 4 (p=0.69).","['patients with small body size following', 'patients stratified by body surface area', 'Patients with Small Body Surface Area after HeartMate 3 (HM3', 'patients with advanced heart failure who are otherwise candidates for durable mechanical support', 'One hundred and nineteen patients were included in this analysis', 'Group 1 patients were older and mostly females', 'Patients who received a HeartMate 3 LVAD at our institution between October 1, 2015 and June 30, 2019 were analyzed']","['HM3 LVAD implantation', 'Left Ventricular Assist Device (LVAD) Implantation', 'HM3 LVAD']","['Kaplan Meier survival curves', 'Pump speed at the time of discharge', 'One-year survival', 'Mean postoperative length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0005901', 'cui_str': 'Body Size'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",119.0,0.0727222,"One-year survival was 93% for group 1, 85% for group 2, 86% for group 3 and 84% for group 4 (p=0.69).","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Molina', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Sheikh', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Rodrigo', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hofmeyer', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kadakkal', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kitahara', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.229']
2897,32465726,C-reactive Protein Levels Predict Right Ventricular Failure and Mortality in Patients Undergoing Continuous-Flow Left Ventricular Assist Device Assist Device Implantation: An INTERMACS Analysis.,"PURPOSE


Whether C-reactive protein (CRP) levels prior to left ventricular assist device implantation (LVAD) are predictive of post-implantation outcomes is not well established. Current data are limited to small, single-center studies.
METHODS


5,183 adult recipients of continuous-flow left ventricular assist devices with pre-implant CRP measurement were identified from INTERMACS. Patients were divided into three groups based on pre-implant CRP levels: CRP of 0 to 10 mg/L (low), 11 to 30 mg/L (intermediate), and >30 mg/L (high). Outcomes of interest were mortality, gastrointestinal bleeding, device thrombosis, infection, stroke, and right heart failure. Analyses included Kaplan-Meier survival estimates and Cox proportional hazards models.
RESULTS


Patients with higher pre-implant CRP were younger (55.3 vs 56.5 vs 57.8 yrs), had sicker INTERMACS profiles (Class I: 33.7% vs 22.6% vs 9.5%); higher use of IABP (34.1% vs 26.0% vs 14.5%) and ECMO (12.0% vs 6.9% vs 2.1%) compared to patients with intermediate and low CRP levels (all p <0.001). High CRP group had higher WBC count (10.4 vs 9.3 vs 8.0 × 10/uL), total bilirubin (1.6 vs 1.4 vs 1.2 mg/dL), and serum BNP levels (958 vs 887 vs 726 pg/mL) compared to lower CRP groups (all p<0.001). After adjustment for baseline characteristics, compared to the low CRP group, higher CRP was associated with greater risk of mortality (HR 1.14 for intermediate CRP, HR 1.29 for high CRP, p=0.006) and right heart failure (HR 0.91 for intermediate CRP, HR 1.41 for high CRP, p=0.004). Rates of device thrombosis, device-related infection, stroke, and gastrointestinal bleeding were similar across groups.
CONCLUSION


Higher CRP levels indicate comorbidity prior to LVAD implantation and predict higher risk of post-implant right heart failure and mortality. These findings suggest that baseline CRP may be a useful predictor of clinical outcome after LVAD implantation.",2020,"High CRP group had higher WBC count (10.4 vs 9.3 vs 8.0 × 10/uL), total bilirubin (","['5,183 adult recipients of continuous-flow left ventricular assist devices with pre-implant CRP measurement', 'Patients']","['C-reactive protein (CRP) levels prior to left ventricular assist device implantation (LVAD', 'Undergoing Continuous-Flow Left Ventricular Assist Device Assist Device Implantation']","['mortality, gastrointestinal bleeding, device thrombosis, infection, stroke, and right heart failure', 'risk of mortality', 'ECMO', 'WBC count', 'low CRP levels', 'total bilirubin ', 'IABP', 'right heart failure', 'Rates of device thrombosis, device-related infection, stroke, and gastrointestinal bleeding', 'serum BNP levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump'}, {'cui': 'C0085073', 'cui_str': 'Infections, Prosthesis-Related'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5183.0,0.030123,"High CRP group had higher WBC count (10.4 vs 9.3 vs 8.0 × 10/uL), total bilirubin (","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Batra', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Truby', 'Affiliation': 'Medicine, Duke University, Durham, NC.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garan', 'Affiliation': 'Medicine, Harvard University, Boston, MA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haythe', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lin', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Axsom', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yuzefpolskaya', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Colombo', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sayer', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Surgery, Columbia University, New York, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farr', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Topkara', 'Affiliation': 'Medicine, Columbia University, New York, NY.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.231']
2898,32465728,Outcomes in Patients with Smaller Left Ventricular End Diastolic Diameter Following HeartMate 3 (HM3) Left Ventricular Assist Device (LVAD) Implantation.,"PURPOSE


Outcomes in patients with small left ventricular end diastolic diameter (LVEDD) following HM3 LVAD implantation have not been well characterized. We sought to compare the clinical outcomes of patients with small LVEDD to those with dilated left ventricles.
METHODS


Patients who received a HeartMate 3 LVAD at our institution between October 1, 2015 and June 30, 2019 were analyzed. Patients who received a HM3 LVAD as a pump exchange were excluded. The cohort was divided in 2 groups: smaller LVEDD (≤60 mm in males and ≤58 mm in females) and larger LVEDD (>60 mm in males and >58 mm in females).
RESULTS


One hundred and nineteen patients underwent HeartMate 3 LVAD implantation at our institution. Patients in the smaller LVEDD group (n: 22) had a mean LVEDD of 55.7±5 mm and patients in the larger LVEDD group had a mean LVEDD of 70.6±8 mm (p=<0.0001). Patients in the smaller LVEDD group tended to be older (60±11 vs 56±11 years, p=0.07), and included more males (82% vs. 68%, p=0.3) and fewer African-Americans (59% vs. 79%, p=0.08). Patients in the smaller LVEDD group were more likely to have a history of ischemic cardiomyopathy (50% vs. 23%, p=0.01), CAD (82% vs. 30%, p<0.001)) and diabetes (73% vs. 47%, p=0.03). INTERMACS class 1 + 2 was similar between groups (72% vs. 68%, p=0.9). Mean days on the ventilator (2.4±3 vs. 3.2±5 days, p=0.5), on inotropes (16±12 vs. 15±8 days, p=0.69) and vasopressors (9±9 vs. 7±11 days, p=0.6) was similar between groups. Mean length of stay (25±14 vs. 29±17 days, p=0.2) and readmissions days (25±52 vs. 27±46 days, p=0.8) were also similar. One-year survival was 90% for the smaller LVEDD group and 95% for the larger LVEDD group (Figure, log rank 0.696).
CONCLUSION


Adult patients with smaller LVEDD who received a HeartMate 3 LVAD have comparable clinical outcomes to patients with larger LVEDD. A small left ventricle should not be a contraindication to implantation of this particular durable device in adult patients.",2020,"One-year survival was 90% for the smaller LVEDD group and 95% for the larger LVEDD group (Figure, log rank 0.696).
","['Adult patients with smaller LVEDD', 'patients with small LVEDD to those with dilated left ventricles', 'patients with small left ventricular end diastolic diameter (LVEDD) following', 'adult patients', 'One hundred and nineteen patients underwent', 'Patients with Smaller Left Ventricular End Diastolic Diameter Following HeartMate 3 (HM3', '≤60 mm in males and ≤58 mm in females) and larger LVEDD (>60 mm in males and >58 mm in females', 'Patients who received a HeartMate 3 LVAD at our institution between October 1, 2015 and June 30, 2019 were analyzed']","['smaller LVEDD', 'Left Ventricular Assist Device (LVAD) Implantation', 'HM3 LVAD implantation', 'HeartMate 3 LVAD implantation', 'HM3 LVAD']","['Mean length of stay', 'CAD', 'mean LVEDD', 'One-year survival', 'history of ischemic cardiomyopathy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}]",119.0,0.0788257,"One-year survival was 90% for the smaller LVEDD group and 95% for the larger LVEDD group (Figure, log rank 0.696).
","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Molina', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Sheikh', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Rodrigo', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hofmeyer', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kadakkal', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kitahara', 'Affiliation': 'Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Advanced Heart Failure, Medstar Washington Hospital Center, Washington, DC.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.233']
2899,30762290,Body weight and eGFR during dulaglutide treatment in type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7).,"In patients with type 2 dibetes and moderate-to-severe chronic kidney disease, dulaglutide treatment led to body weight (BW) loss and lesser eGFR decline compared to insulin glargine. As BW may affect muscle mass, creatinine-based eGFR can be altered independently of kidney function. Cystatin C-based eGFR is not affected by muscle mass. The objective of this post-hoc analysis was to determine whether the lesser eGFR decline with dulaglutide was related to BW loss. Baseline characteristics were similar between treatments ([mean ± SD] age, 64.6 ± 8.6 years; women, 48%; BW, 89.1 ± 17.7 kg; eGFR [CKD-EPI-cystatin C] 38 ± 14 mL/min/1.73m 2  ). BW decreased with dulaglutide 1.5 and 0.75 mg and increased with insulin glargine ([LSM change (SE)], -2.66 [0.47] kg and -1.71 [0.45] vs 1.57 [0.43] kg; P < 0.001). Changes in eGFR were not significant with dulaglutide 1.5 and 0.75 mg, but eGFR significantly decreased with insulin glargine (eGFR-CKD-EPI-cystatin C [LSM change (95%CI)], -0.7 [-2.5, 1.0] and -0.7 [-2.4, 1.1] vs -3.3 [-5.1, -1.6] mL/min/1.73 m 2  ; P ≤ 0.037 vs glargine). Changes in BW did not correlate with changes in eGFR-CKD-EPI-cystatin C (r = -0.041; n = 471; P = 0.379) or eGFR-CKD-EPI-creatinine (r = -0.074; n = 473; P = 0.106). In conclusion, the lesser decline in eGFR observed with dulaglutide was not influenced by BW loss.",2019,"Changes in eGFR were not significant with dulaglutide 1.5 and 0.75 mg, but eGFR significantly decreased with insulin glargine (eGFR-CKD-EPI-cystatin C [LSM change (95%CI)], -0.7 [-2.5, 1.0] and -0.7",['type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7'],['insulin glargine'],"['eGFR-CKD-EPI-cystatin C', 'Body weight and eGFR', 'eGFR', 'eGFR decline with dulaglutide', 'insulin glargine ([LSM change (SE', 'insulin glargine (eGFR-CKD-EPI-cystatin C [LSM change (95%CI', 'Changes in eGFR', 'body weight (BW) loss and lesser eGFR decline']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0004446', 'cui_str': 'Awards'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439092', 'cui_str': '<'}]",,0.0545359,"Changes in eGFR were not significant with dulaglutide 1.5 and 0.75 mg, but eGFR significantly decreased with insulin glargine (eGFR-CKD-EPI-cystatin C [LSM change (95%CI)], -0.7 [-2.5, 1.0] and -0.7","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'Providence Health Care, University of Washington, Spokane, Washington.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Lilly Diabetes Development, Indianapolis, Indiana.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rayner', 'Affiliation': 'Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Lilly Diabetes Development, Indianapolis, Indiana.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Woodward', 'Affiliation': 'Eli Lilly and Company, Lilly Diabetes Development, Indianapolis, Indiana.'}, {'ForeName': 'Fady T', 'Initials': 'FT', 'LastName': 'Botros', 'Affiliation': 'Eli Lilly and Company, Lilly Diabetes Development, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13668']
2900,31174584,Spinal radiographic progression over 2 years in ankylosing spondylitis patients treated with secukinumab: a historical cohort comparison.,"OBJECTIVE


The aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS).
METHODS


Baseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31-743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs.
RESULTS


A total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant.
CONCLUSION


Secukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.",2019,Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses.,"['patients with baseline (≤\u2009day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (>\u2009day 30) radiographs', '168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set', 'patients with baseline (≤\u2009day 30) and post-baseline day 31-743 radiographs', 'Baseline and 2-year lateral cervical and lumbar spine radiographs', 'patients with ankylosing spondylitis (AS) treated for up to 2\u2009years with secukinumab']","['NSAIDs (ENRADAS', 'secukinumab']","['proportion of non-progressors and lower change in mSASSS', 'proportion of patients with no radiographic progression (mSASSS change', 'radiographic progression', 'Spinal radiographic progression', 'proportion of patients with no radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",168.0,0.110251,Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Herne, Herne, Germany. juergen.braun@elisabethgruppe.de.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Haibel', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Hooge', 'Affiliation': 'VIB Inflammation Research Center, Ghent University, Ghent, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Landewé', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rudwaleit', 'Affiliation': 'Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fox', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Readie', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Richards', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sieper', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'VIB Inflammation Research Center, Ghent University, Ghent, Belgium.'}]",Arthritis research & therapy,['10.1186/s13075-019-1911-1']
2901,31185221,Primary prevention of severe lower respiratory illnesses in at-risk infants using the immunomodulator OM-85.,,2019,,[],['immunomodulator OM-85'],[],[],"[{'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}]",[],,0.0190327,,"[{'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sly', 'Affiliation': ""Children's Health and Environment Program, Child Health Research Centre, University of Queensland, South Brisbane, Australia. Electronic address: p.sly@uq.edu.au.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Galbraith', 'Affiliation': ""Children's Health and Environment Program, Child Health Research Centre, University of Queensland, South Brisbane, Australia.""}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Islam', 'Affiliation': ""Children's Health and Environment Program, Child Health Research Centre, University of Queensland, South Brisbane, Australia.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Holt', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Troy', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Holt', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.05.032']
2902,31222157,Early limited formula for breastfeeding infants: too much or just enough?,,2019,,['breastfeeding infants'],[],[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],[],,0.0175993,,"[{'ForeName': 'Miren B', 'Initials': 'MB', 'LastName': 'Dhudasia', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia/University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Flannery', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia/University of Pennsylvania, Philadelphia, PA, USA. flanneryd@email.chop.edu.""}, {'ForeName': 'Sagori', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia/University of Pennsylvania, Philadelphia, PA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0419-5']
2903,31811497,"Comparison of the effect of photobiomodulation therapy and Ibuprofen on postoperative pain after endodontic treatment: randomized, controlled, clinical study.","The aim of the study was to compare the effect of Ibuprofen and the application of photobiomodulation therapy protocol on the reduction of postoperative pain in endodontically treated teeth using a randomized clinical trial design. Seventy patients, diagnosed with symptomatic irreversible pulpitis, were selected. Treatment was performed by a single operator; a reciprocal system was used to prepare the canals; they were obturated using the Tagger's hybrid technique and coronally sealed with glass-ionomer cement. After treatment, patients were randomly divided into 2 groups. In the active control group, two Ibuprofen 600 mg tablets were administered within a 12-h interval. In the photobiomodulation therapy group, the irradiation was applied after treatment. The evaluation of postoperative pain was performed by another researcher blinded to the groups at 6, 12, 24, and 72 h intervals after treatment. To measure the outcome, two pain scales were used: numerical rate scale (NRS) and verbal rate scale (VRS). Data were analyzed using the chi-square, Mann-Whitney, and Wilcoxon paired tests. Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen. The results for the 72 h (p = 0.317) interval were similar, both in the VRS and NRS scales. It may be concluded that the use of photobiomodulation therapy was effective in reducing pain within the first 24 h when compared with the administration of Ibuprofen 600 mg.",2020,"Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen.","['Seventy patients, diagnosed with symptomatic irreversible pulpitis']","['photobiomodulation therapy protocol', 'Ibuprofen', 'photobiomodulation therapy', 'photobiomodulation therapy and Ibuprofen', ""Tagger's hybrid technique and coronally sealed with glass-ionomer cement""]","['postoperative pain', 'numerical rate scale (NRS) and verbal rate scale (VRS', 'pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0399194,"Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen.","[{'ForeName': 'Eduardo Costa', 'Initials': 'EC', 'LastName': 'Nunes', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Fernando José', 'Initials': 'FJ', 'LastName': 'Herkrath', 'Affiliation': 'Leônidas & Maria Deane Institute, Oswaldo Cruz Foundation, Manaus, Brazil.'}, {'ForeName': 'Eduardo Hideki', 'Initials': 'EH', 'LastName': 'Suzuki', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Erivan Clementino', 'Initials': 'EC', 'LastName': 'Gualberto Júnior', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'André Augusto Franco', 'Initials': 'AAF', 'LastName': 'Marques', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Emílio Carlos', 'Initials': 'EC', 'LastName': 'Sponchiado Júnior', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil. spemilio@ufam.edu.br.'}]",Lasers in medical science,['10.1007/s10103-019-02929-8']
2904,32465737,Association of Patient Health-Related Quality of Life and Caregiver Burden in Older Heart Failure Patients Receiving Advanced Therapies: Findings from the SustainIng QualItY of Life of the Aged: Transplant or Mechanical Support (SustAIn-it) Study.,"PURPOSE


Caregivers (CGs) of patients (PTs) with heart failure (HF) experience substantial CG burden. Poor PT health-related quality of life (HRQOL) correlates with increased CG burden in other chronic disease. We evaluated the relationship between PT HRQOL and CG burden in older PTs receiving left ventricular assist devices (LVAD) as destination therapy (DT) or awaiting heart transplant (HT) with or without an LVAD.
METHODS


Data were from SUSTAIN-IT, a study of PT and CG HRQOL in adults age 60-80 receiving DT LVAD or HT. PT HRQOL was assessed by EQ-5D-3L Visual Analog Scale (VAS) score: 0-100 (worst-best) & HF-specific KCCQ-12 summary score (SS), 0-100=low-high. CG burden was assessed by Oberst Caregiving Burden Scale (OCBS) assessing perceptions of CG difficulty & time (1-5; higher score=more time & difficulty). Baseline CG burden, PT HRQOL, and changes from 0 to 6 months were compared by linear regression.
RESULTS


Data from 302 PTs and CGs were analyzed: 109 DT LVAD, 193 HT (101 without LVAD & 92 with LVAD). KCCQ-12 and EQ-5D VAS scores increased significantly from 0 to 6 months (p < 0.001). Baseline OCBS time had weak, but significant correlation with baseline PT KCCQ-12 (R=-0.26, p<0.001); correlation was slightly stronger at 6 months (R=-0.41, p<0.001). OCBS time was weakly associated with PT EQ-5D at 6 months (R=-0.2, p=0.009) but not at baseline (R=-0.1, p=0.09). Change in PT KCCQ-12 significantly correlated with change in OCBS time in DT LVAD (R=-0.33, p=0.01) but not HT with (p=0.46) or without LVAD (p=0.31). Change in PT EQ-5D and OCBS difficulty were not significantly correlated.
CONCLUSION


PT HRQOL generally correlated with CG burden in older HF PTs before and early after DT and HT. Improved PT HRQOL did not correlate with decreased CG burden in HT, but may be associated in DT LVAD. These findings may guide support needs of CGs of PTs undergoing advanced therapies.",2020,KCCQ-12 and EQ-5D VAS scores increased significantly from 0 to 6 months (p < 0.001).,"['Caregivers (CGs) of patients (PTs) with heart failure (HF) experience substantial CG burden', 'older PTs receiving', 'adults age 60-80 receiving DT LVAD or HT', 'Data from 302 PTs and CGs were analyzed', 'Older Heart Failure Patients Receiving Advanced Therapies']",['left ventricular assist devices (LVAD) as destination therapy (DT) or awaiting heart transplant (HT) with or without an LVAD'],"['KCCQ-12 and EQ-5D VAS scores', 'PT EQ-5D', 'Oberst Caregiving Burden Scale (OCBS) assessing perceptions of CG difficulty & time', 'OCBS time in DT LVAD', 'baseline PT KCCQ-12', 'Improved PT HRQOL', 'PT HRQOL', 'Baseline OCBS time', 'Baseline CG burden, PT HRQOL', 'OCBS time', 'Change in PT EQ-5D and OCBS difficulty', 'Poor PT health-related quality of life (HRQOL', 'EQ-5D-3L Visual Analog Scale (VAS) score: 0-100 (worst-best) & HF-specific KCCQ-12 summary score (SS']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0650343,KCCQ-12 and EQ-5D VAS scores increased significantly from 0 to 6 months (p < 0.001).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slivnick', 'Affiliation': 'Ohio State Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lampert', 'Affiliation': 'Ohio State Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Andrei', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Warzecha', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kao', 'Affiliation': ""St. Luke's, Kansas City, MO.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hsich', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dew', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Kormos', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Pham', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Petty', 'Affiliation': 'University of Minnesota Fairview Medical, Minneapolis, MN.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cotts', 'Affiliation': 'Advocate Christ Hospital, Oak Lawn, IL.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pamboukian', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Johnson', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Murray', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Columbia University Medical Center, New York City, NY.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yuzefpolskaya', 'Affiliation': 'Columbia University Medical Center, New York City, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Silvestry', 'Affiliation': 'Florida Transplant Institute, Orlando, FL.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spertus', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, MO.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kirklin', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Collum', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grady', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.242']
2905,32465739,Improved Quality of Life and Functional Performance Post-LVAD Surgery Using Hemodynamic Guided Optimization Pre-LVAD Surgery.,"PURPOSE


We assessed the effect of pre-operative hemodynamically optimization by CardioMEMS on the outcome of LVAD patients in relation to the quality of life (QoL) and functional performance.
METHODS


Ten consecutive chronic heart failure patients, with an INTERMACS Class 2-5, scheduled for (semi-) elective LVAD surgery were enrolled in the HEMO-VAD pilot study. The median age was 59.7 [52.4-63.0] years and 70.0% of patients were men. All patients received before LVAD surgery a CardioMEMS device on a median of 13.5 (range 3-23) days before surgery. The daily hemodynamic readings were used to guide the patient's optimization process. Aims of hemodynamically optimization were normalization of the mean pulmonary artery pressure (mPAP) and decongesting of the right ventricle and optimization of the renal function. In this analysis, we investigated the change in the quality of life (QoL) (according to the EQ-5D-5L, KCCQ, and PHQ-9 questionnaires) and 6-minute walking distance between baseline and 3 months of follow-up.
RESULTS


The QoL improved in both groups between baseline and 3 months of follow-up, measured in all three questionnaires. Also the 6-minute walking distance improved significantly in both groups between baseline and 3 months of follow-up. Interestingly, the improvement in the EQ-5D-5L (+38.8±15.1 vs. +16.6±4.9) and 6-minute walking distance (+395.9±43.6 vs. +147.9±102.7) was bigger in patients who were hemodynamically optimized pre-LVAD surgery.
CONCLUSION


QoL and functional performance improved in the first 3 months post-LVAD surgery. Patients who were hemodynamically optimized pre-LVAD surgery using the CardioMEMS seem to improve more in QoL and functional performance compared to those not hemodynamically optimized.",2020,Patients who were hemodynamically optimized pre-LVAD surgery using the CardioMEMS seem to improve more in QoL and functional performance compared to those not hemodynamically optimized.,"['The median age was 59.7 [52.4-63.0] years and 70.0% of patients were men', 'Patients who were hemodynamically optimized pre-LVAD surgery using the', 'Ten consecutive chronic heart failure patients, with an INTERMACS Class 2-5, scheduled for (semi-) elective LVAD surgery were enrolled in the HEMO-VAD pilot study']","['CardioMEMS', 'LVAD surgery a CardioMEMS device']","['6-minute walking distance', 'quality of life (QoL) (according to the EQ-5D-5L, KCCQ, and PHQ-9 questionnaires) and 6-minute walking distance', 'QoL', 'mean pulmonary artery pressure (mPAP) and decongesting of the right ventricle and optimization of the renal function', 'Improved Quality of Life and Functional Performance', 'QoL and functional performance', 'EQ-5D-5L', 'quality of life (QoL) and functional performance']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0077973', 'cui_str': 'VAD I protocol'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C1529255', 'cui_str': 'Decongest'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",10.0,0.0462772,Patients who were hemodynamically optimized pre-LVAD surgery using the CardioMEMS seem to improve more in QoL and functional performance compared to those not hemodynamically optimized.,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Veenis', 'Affiliation': 'Cardiology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Brugts', 'Affiliation': 'Cardiology, Erasmus MC, Rotterdam, Netherlands.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.244']
2906,32465740,Elevation of Right-Sided Pressures and Right Ventricular Echocardiographic Parameters: Predictors of Exercise Limitation in Patients with Implanted Continuous Flow Left Ventricular Assist Devices.,"PURPOSE


To determine parameters of exercise intolerance in a group of patients with HeartWare Ventricular Assist Device(HVAD) compared to a group of heart failure(HF)patients METHODS: This was a single-centre parallel prospective group-study.Echocardiograms,right heart catheterisation(RHC) and cardiopulmonary exercise tests were performed in 42patients admitted for a heart transplant assessment between August2017 and October2018:20 belonged to the HVAD group and 22 to the HF group RESULTS: HVADpatients had a better exercise capacity than HFpatients, although no significant differences were noted(14.0±5.0ml/kg/min vs 11.3±3.9ml/kg/min, p=0.06).To determine exercise tolerance,both HVAD and HFgroups were subdivided into 2 groups based on the median peakVO2.The table shows the comparison between preserved and non-preserved exercise tolerance in HF and HVADpatients. In the HVAD group,all resting RHC pressures were significantly lower in the preserved exercise capacity group.However,in HFpatients there were no statistically significant differences between both subgroups in right-sided pressures,but Thermodilution exercise-induced change in cardiac output(ΔCO) and cardiac index(ΔCI) was significantly higher in the patients with preserved exercise tolerance.In the HVADgroup the right ventricle was significantly larger in the reduced exercise tolerance subgroup.Patients with lower peakVO2 had more significant tricuspid regurgitation.Nevertheless,in HFpatients none of the echocardiographic parameters were related to the exercise capacity CONCLUSION: Right-sided parameters in the echocardiogram and RHC pressures discriminate between preserved and non-preserved exercise capacity in HVADpatients,but not in HFpatients.In these last patients only ΔCO and ΔCI were statistically correlated with peak exercise oxygen consumption.",2020,"HVADpatients had a better exercise capacity than HFpatients, although no significant differences were noted(14.0±5.0ml/kg/min vs 11.3±3.9ml/kg/min, p=0.06).To determine exercise tolerance,both HVAD and HFgroups were subdivided into 2 groups based on the median peakVO2.The table shows the comparison between preserved and non-preserved exercise tolerance in HF and HVADpatients.","['a group of patients with HeartWare Ventricular Assist Device(HVAD', 'Patients with Implanted Continuous Flow Left Ventricular Assist Devices', '42patients admitted for a heart transplant assessment between August2017 and October2018:20 belonged to the HVAD group and 22 to the HF group']",[],"['exercise capacity', 'tricuspid regurgitation', 'Echocardiograms,right heart catheterisation(RHC) and cardiopulmonary exercise tests', 'right-sided pressures,but Thermodilution exercise-induced change in cardiac output(ΔCO) and cardiac index(ΔCI', 'peak exercise oxygen consumption', 'resting RHC pressures']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0039807', 'cui_str': 'Thermodilution'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0174405,"HVADpatients had a better exercise capacity than HFpatients, although no significant differences were noted(14.0±5.0ml/kg/min vs 11.3±3.9ml/kg/min, p=0.06).To determine exercise tolerance,both HVAD and HFgroups were subdivided into 2 groups based on the median peakVO2.The table shows the comparison between preserved and non-preserved exercise tolerance in HF and HVADpatients.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bouzas-Cruz', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gonzalez-Fernandez', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koshy', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Okwose', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Robinson-Smith', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tovey', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDiarmid', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Parry', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schueler', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jakovljevic', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacGowan', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.245']
2907,32465752,Safety and Efficacy of Single Dose Del Nido Cardioplegia Solution in Left Ventricular Assist Device Implantation- A Propensity Matched Study.,"PURPOSE


Del Nido cardioplegia (DN) has recently become more in common use as a ""single"" dose cardioplegia in adult cardiac surgery. However, it is not well described in left ventricular assist device (LVAD) surgery. The purpose of this study was to summarize our clinical experience with single dose DN solution in LVAD implantation and to assess the safety and efficacy of our DN protocol by comparing with conventional cold whole blood cardioplegia (CWB).
METHODS


A total of 524 consecutive patients underwent LVAD implantation between July 2008 and August 2019. Among them, 137 patients who required aortic cross-clamp for concomitant cardiac procedures were included in this study. The DN protocol was to administer the initial dose as a single dose. CWB was given every 20 minutes. Propensity matching identified 40 matched pairs for analysis.
RESULTS


Cross-clamp time was significantly shorter in the DN group compared with the CWB group (58± 20 min vs. 70± 33 min, p=0.0497). The retrograde cardioplegia technique was used in 6 (15.0%) patients in the DN group and 36 (90.0%) patients in the CWB group (p<0.0001). There were no significant differences in the rates of postoperative prolonged use of inotropes (>14 days) (DN: 3/40, 7.5% vs. CWB: 3/40, 7.5%, p=1), requiring postoperative right VAD (DN: 2/40, 5.0% vs. CWB: 2/40, 5.0%, p=1), and requiring blood transfusion (Table). Freedom from re-admission at 1 year was similar between two groups (DN: 69.6±7.7% vs. CWB: 74.3±7.5%, Log-Rank p=0.5522).
CONCLUSION


Mid-term clinical outcomes in the patients undergoing LVAD implantation with the DN protocol was acceptable. This study showed the DN protocol was associated with shortened cross-clamp time and less frequent usage of the retrograde cannula technique.",2020,"RESULTS


Cross-clamp time was significantly shorter in the DN group compared with the CWB group (58± 20 min vs. 70± 33 min, p=0.0497).","['137 patients who required aortic cross-clamp for concomitant cardiac procedures', '524 consecutive patients underwent LVAD implantation between July 2008 and August 2019']","['Implantation', 'conventional cold whole blood cardioplegia (CWB', 'CWB', 'Single Dose Del Nido Cardioplegia Solution']","['requiring postoperative right VAD', 'Safety and Efficacy', 'retrograde cardioplegia technique', 'rates of postoperative prolonged use of inotropes', 'safety and efficacy', 'Cross-clamp time']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1279986', 'cui_str': 'Procedure on heart'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0077973', 'cui_str': 'VAD I protocol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",524.0,0.106402,"RESULTS


Cross-clamp time was significantly shorter in the DN group compared with the CWB group (58± 20 min vs. 70± 33 min, p=0.0497).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Koda', 'Affiliation': 'Surgery, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nishida', 'Affiliation': 'Surgery, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Surgery, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ota', 'Affiliation': 'Surgery, The University of Chicago Medicine, Chicago, IL.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.255']
2908,32465762,Pre-Operative Hemodynamic Guidance by Cardiomems to Improve LVAD Outcome.,"PURPOSE


LVAD therapy remains a complex treatment, associated with high mortality and morbidity. Optimizing patients shortly before LVAD surgery can improve post-surgery outcomes. Therefore, we aimed to investigate the feasibility of pre-LVAD surgery optimization using the hemodynamic monitoring provided by the CardioMEMS to improve post-LVAD surgery outcome.
METHODS


Ten consecutive chronic heart failure patients, with an INTERMACS Class 2-5, scheduled for (semi-) elective LVAD surgery where enrolled in the HEMO-VAD pilot study. The median age was 59.7 [52.4-63.0] years, and 70.0% of patients were men. All patients received before LVAD surgery a CardioMEMS device. The daily hemodynamic readings were used to guide the patient optimization process pre and post-operative. Aims of hemodynamically optimization were normalization of the mean pulmonary artery pressure (mPAP) and decongesting of the right ventricle and optimization of the renal function. In this analysis, we investigated the occurrence of a combined endpoint of all-cause mortality, right-sided HF or renal replacement therapy (RRT) during the first 3 months of follow-up (time to first event analysis).
RESULTS


During the optimization period, the mean cumulative reduction of mPAP was larger in the hemodynamic optimized patients (-58.8±82.9mmHg day) compared with those not hemodynamically optimized (0.8±29.3mmHg day). During the first three months post-LVAD surgery, the combined endpoint occurred in four out of six not hemodynamically optimized patient, compared to none off the hemodynamically optimized patients (p=0.05) (Figure). A trend towards better event-free survival of right-sided HF and RRT was observed in hemodynamically optimized patients.
CONCLUSION


This pilot study demonstrates the feasibility of hemodynamic guided optimization using the CardioMEMS before LVAD surgery, which identified a group of patients at increased risk of all-cause mortality, right-sided HF, and RRT if not hemodynamically optimized pre-operatively.",2020,"A trend towards better event-free survival of right-sided HF and RRT was observed in hemodynamically optimized patients.
","['The median age was 59.7 [52.4-63.0] years, and 70.0% of patients were men', 'Ten consecutive chronic heart failure patients, with an INTERMACS Class 2-5, scheduled for (semi-) elective LVAD surgery where enrolled in the HEMO-VAD pilot study']","['renal replacement therapy (RRT', 'LVAD surgery a CardioMEMS device']","['mean pulmonary artery pressure (mPAP) and decongesting of the right ventricle and optimization of the renal function', 'mean cumulative reduction of mPAP']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0077973', 'cui_str': 'VAD I protocol'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C1529255', 'cui_str': 'Decongest'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",10.0,0.0195412,"A trend towards better event-free survival of right-sided HF and RRT was observed in hemodynamically optimized patients.
","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Veenis', 'Affiliation': 'Cardiology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Brugts', 'Affiliation': 'Cardiology, Erasmus MC, Rotterdam, Netherlands.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.265']
2909,32465767,Desensitization in Mechanical Circulatory Support Patients Awaiting Heart Transplantation: What is the Post-Transplant Outcome?,"PURPOSE


Sensitization occurs with blood transfusions in recipients of left ventricular assist device (LVAD). 30% of LVAD patients develop a panel reactive antibody (PRA) screen of >= 10%. Highly sensitized patients have an increased morbidity and mortality after heart transplantation. Desensitization therapy is considered for patients with PRAs> 50%. Below are the results of desensitization therapies in mechanical circulatory support (MCS) patients.
METHODS


From 2010-2016, 49 MCS patients who underwent desensitization therapy were compared to a control group who underwent desensitization but did not have MCS support. Desensitization therapy used in both groups included combinations of rituximab/IVIG and plasmapheresis/bortezomib. Baseline PRAs prior to desensitization were repeated 2-4 weeks after treatment. For patients who underwent heart transplantation, outcomes included 1-year survival, freedom from cardiac allograft vasculopathy (CAV), freedom from non-fatal major adverse cardiac events (NF-MACE, defined as myocardial infarction, percutaneous coronary intervention, new congestive heart failure, pacemaker/implantable cardioverter-defibrillator placement, and stroke), and freedom from any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR).
RESULTS


Desensitization therapy was successful in both MCS and control groups, resulting in an average of 12% decrease in PRA. When subgrouped into Class 1 versus Class 2 antibodies, Class 1 antibodies appeared to have a better response after desensitization therapy (PRA decrease of 15% in Class 1 versus a decrease of 9% in Class 2). Patients on MCS support appear to have a numerical lower incidence of AMR with comparable first-year survival, freedom from CAV, NF-MACE, ATR, and ACR.
CONCLUSION


Desensitization of MCS patients appeared to be beneficial. Removal of the MCS device at the time of transplant may be a factor in potentially less AMR post-transplant.",2020,"RESULTS


Desensitization therapy was successful in both MCS and control groups, resulting in an average of 12% decrease in PRA.","['From 2010-2016', 'patients with PRAs> 50', '49 MCS patients who underwent', 'recipients of left ventricular assist device (LVAD', 'Mechanical Circulatory Support Patients Awaiting Heart Transplantation']","['Desensitization therapy', 'rituximab/IVIG and plasmapheresis/bortezomib', 'MCS', 'LVAD', 'desensitization therapy']","['panel reactive antibody (PRA) screen', 'morbidity and mortality', 'PRA', '1-year survival, freedom from cardiac allograft vasculopathy (CAV), freedom from non-fatal major adverse cardiac events (NF-MACE, defined as myocardial infarction, percutaneous coronary intervention, new congestive heart failure, pacemaker/implantable cardioverter-defibrillator placement, and stroke), and freedom from any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0633231', 'cui_str': 'S100A6 protein, human'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]","[{'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C1141951', 'cui_str': 'Panel-reactive antibody'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0564471', 'cui_str': 'Allograft heart'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]",49.0,0.0129438,"RESULTS


Desensitization therapy was successful in both MCS and control groups, resulting in an average of 12% decrease in PRA.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Youn', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Seguchi', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cole', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Geft', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nishihara', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shen', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sharoff', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ramzy', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kobashigawa', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Moriguchi', 'Affiliation': 'Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.269']
2910,32465771,Preliminary Results of a Randomized Clinical Trial of Intravenous Immunoglobulin in Solid Organ Recipients with Severe Infection and Secondary Antibody Deficiency.,"PURPOSE


Infection is a cause of death in solid organ transplantation. Secondary antibody deficiency is a risk factor of severe infection in solid organ transplantation. In a multicenter randomized clinical trial we evaluated the efficacy and safety of an intravenous immunoglobulin (IVIG) protocol to decrease the rate of re-infection in solid organ recipients with severe infections and secondary antibody deficiency.
METHODS


Adult patients (20 Heart, 12 Lung, 5 Kidney, 3 Liver Recipients) with post transplant severe infections and secondary antibody deficiency (IgG levels < 600 mg/dL at the time of the infectious complication) were included. IVIG protocol: Two doses of 15 grams followed by other 3 doses of 20 grams of a 5% IVIG product. 40 patients were randomized to receive IVIG in combination with conventional antimicrobial therapy (n=20) or conventional antimicrobial therapy alone (n=20). At the time of this preliminary report 36 patients that completed the protocol were analysed (17 IVIG + antimicrobial therapy, 19 antimicrobial therapy alone). Distinct specific antibodies were tested at the time of inclusion in the clinical trial and at the time of final visit (visit 7 at 30-45 days after last IVIG dose or similar time in no-IVIG patients) in a subgroup of patients to assess the kinetics of humoral immunity reconstitution.
RESULTS


The primary outcome measure (rate of re-infection) was significantly lower in patients randomized to receive IVIG as compared with patients receiving only conventional antimicrobial therapy (35.3 vs 68.4%, chi-square test, p=0.047). Time to reach normal IgG (IgG > 750 mg/dL) was shorter in IVIG group (55±44 vs 93±42 days, p=0.06). Significantly higher levels of specific anti-cytomegalovirus, anti-clostridium difficile toxins A and B was demonstrated at visit 7 in patients who received IVIG as compared with patients that were treated with antimicrobial therapy alone.
CONCLUSION


In a randomized clinical trial we have preliminarily demonstrated that IVIG is associated with reconstitution of distinct specific antibodies and with a lower rate of re-infection in solid organ transplantation with severe infection and secondary antibody deficiency.",2020,"(IgG > 750 mg/dL) was shorter in IVIG group (55±44 vs 93±42 days, p=0.06).","['solid organ recipients with severe infections and secondary antibody deficiency', 'Solid Organ Recipients with Severe Infection and Secondary Antibody Deficiency', '40 patients', 'Adult patients (20 Heart, 12 Lung, 5 Kidney, 3 Liver Recipients) with post transplant severe infections and secondary antibody deficiency']","['conventional antimicrobial therapy', 'IVIG in combination with conventional antimicrobial therapy', 'intravenous immunoglobulin (IVIG) protocol', 'conventional antimicrobial therapy alone', 'antimicrobial therapy alone', 'Intravenous Immunoglobulin']","['Time to reach normal IgG', 'IgG levels', 'rate of re-infection', 'efficacy and safety', 'kinetics of humoral immunity reconstitution']","[{'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0597744', 'cui_str': 'Secondary antibody deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}]",40.0,0.183436,"(IgG > 750 mg/dL) was shorter in IVIG group (55±44 vs 93±42 days, p=0.06).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carbone', 'Affiliation': 'Clinical Immunology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Montanchez', 'Affiliation': 'Clinical Immunology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cifrian', 'Affiliation': 'Pneumology, Hospital Universitario Marques de Valdecilla, Valencia, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Laporta', 'Affiliation': 'Pneumology, Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ussetti', 'Affiliation': 'Pneumology, Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zatarain', 'Affiliation': 'Cardiology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sousa', 'Affiliation': 'Cardiology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Muñoz', 'Affiliation': 'Microbiology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ezzahouri', 'Affiliation': 'Clinical Immunology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Salcedo', 'Affiliation': 'Gastroenterology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodriguez-Ferrero', 'Affiliation': 'Nephrology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bravo', 'Affiliation': 'Pneumology, Hospital Universitario Valle de Hebron, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Segovia', 'Affiliation': 'Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gomez-Bueno', 'Affiliation': 'Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fernandez-Sabe', 'Affiliation': 'Infectious Diseases, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gonzalez-Costello', 'Affiliation': 'Cardiology, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Pablos', 'Affiliation': 'Pneumology, Hospital Universitario Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sarmiento', 'Affiliation': 'Clinical Immunology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1216']
2911,32465772,Infection-Related Morbidity with Continuous-Flow Left Ventricular Assist Systems: A Comprehensive Analysis of the Randomized MOMENTUM 3 Trial.,"PURPOSE


The MOMENTUM 3 trial established superiority of a fully magnetically-levitated HeartMate 3 (HM3) centrifugal pump over the axial flow HeartMate II (HMII) pump on hemocompatibility-related outcomes. Infection-related outcomes were no different between the two devices. We sought to understand the types of infection, temporal trends, clinical correlates and risk markers over 2-years of support.
METHODS


MOMENTUM 3 randomized 1020 patients to either the HM 3 (515) or HM II (505) groups. Morbidity and mortality related outcomes were analyzed between patients with or without major infection complications. Cox regression analyses were utilized to identify characteristics associated with major infectious complications.
RESULTS


The cumulative number of infections was 1213 (634 HM3 and 579 HMII), and major infection occurred in 58% HM3 and 56% HMII patients (p=0.57). Localized infections unrelated to pump components were most common (n=681/1213; 56%), followed by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and other events (n=9/1213; 0.7%). Bacterial pathogens were implicated in 806/1213 events (66%) and significant predictors of infection included gender (men vs. women; HR:0.73, p=0.003), BUN (HR:1.12, p=0.01), preimplant history of cardiac surgery (HR:1.28, p=0.01), and BMI≥30 (HR:1.43, p<0.0001). Most deaths in those with infection ultimately occurred due to non-infectious causes (Figure).
CONCLUSION


Infection is the commonest adverse effect in patients implanted with contemporary continuous-flow pumps with most such events presenting as events unrelated to the pump components. Whether mechanical circulatory devices confer an immunosuppressive effect leading to propensity for infection warrants closer scrutiny to understand and ameliorate this morbidity. (Funded by Abbott; MOMENTUM 3 NCT02224755).",2020,"Localized infections unrelated to pump components were most common (n=681/1213; 56%), followed by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and other events (n=9/1213; 0.7%).",['3 randomized 1020 patients to either the HM 3 (515) or HM II (505) groups'],"['Continuous-Flow Left Ventricular Assist Systems', 'fully magnetically-levitated HeartMate 3 (HM3) centrifugal pump over the axial flow HeartMate II (HMII) pump']","['preimplant history of cardiac surgery', 'Bacterial pathogens', 'major infection', 'cumulative number of infections', 'Morbidity and mortality related outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0444755', 'cui_str': 'Centrifugal pump'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0455618', 'cui_str': 'H/O cardiac surgery'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1020.0,0.0928109,"Localized infections unrelated to pump components were most common (n=681/1213; 56%), followed by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and other events (n=9/1213; 0.7%).","[{'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Bailey', 'Affiliation': 'Allegheny General Hospital, Pittsburg, PA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Blue', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cagliostro', 'Affiliation': 'New York-Presbyterian/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Entwistle', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'John', 'Affiliation': 'University of Minnesota Medical Center, Minneapolis, MN.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Thohan', 'Affiliation': 'Mission Health System, Asheville, NC.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Abbott, Abbott Park, IL.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Somo', 'Affiliation': 'Abbott, Abbott Park, IL.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott, Abbott Park, IL.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1215']
2912,30412325,The accuracy of baseline viral load for predicting the efficacy of elbasvir/grazoprevir in participants with hepatitis C virus genotype 1a infection: An integrated analysis.,"European treatment guidelines for hepatitis C virus (HCV) infection recommend that people with genotype (GT) 1a infection and baseline viral load ≤800 000 IU/mL receive elbasvir/grazoprevir (EBR/GZR) for 12 weeks, and those with baseline viral load >800 000 IU/mL receive EBR/GZR plus ribavirin for 16 weeks. This analysis was conducted to clarify whether baseline viral load can serve as an accurate, sensitive or specific stratification factor for defining EBR/GZR regimens. In this post hoc, integrated analysis, participants with GT1a infection who received EBR 50 mg/GZR 100 mg for 12 weeks were stratified according to baseline viral load. Sustained virologic response at 12 weeks post-treatment was achieved by 95.2% (911/957) of participants and was higher among participants with baseline viral load ≤800 000 IU/mL vs >800 000 IU/mL (98.5% vs 93.9%). The 800 000 IU/mL threshold had a positive predictive value of 98.5%, a negative predictive value of 6.1%, a specificity of 91.3%, a sensitivity of 28.4% and an overall accuracy of 31.5%. A baseline viral load cutpoint of 800 000 IU/mL had high positive predictive value and specificity but poor negative predictive value, sensitivity and accuracy in predicting treatment outcomes in this population. Baseline NS5A resistance-associated substitutions (RASs) were detected in 25% (1/4) of virologic failures with baseline viral load ≤800 000 IU/mL and 59.5% (25/42) of those with baseline viral load >800 000 IU/mL. Overall, these data suggest that, compared with the use of a baseline viral load cutpoint, baseline testing for NS5A RASs enables more individuals to receive the 12-week EBR/GZR regimen without compromising the opportunity for SVR.",2019,"IU/mL had high positive predictive value and specificity but poor negative predictive value, sensitivity and accuracy in predicting treatment outcomes in this population.","['800\xa0000', 'participants with hepatitis C virus genotype 1a infection', 'participants with GT1a infection who received', 'people with genotype (GT) 1a infection and baseline viral load ≤800\xa0000']","['EBR/GZR plus ribavirin', 'IU/mL receive elbasvir/grazoprevir (EBR/GZR', 'elbasvir/grazoprevir', 'EBR 50\xa0mg/GZR', 'IU/mL']","['virologic failures', 'Sustained virologic response', 'Baseline NS5A resistance-associated substitutions (RASs']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C1533728', 'cui_str': 'Hepatitis C virus genotype determination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]","[{'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}]","[{'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",,0.243444,"IU/mL had high positive predictive value and specificity but poor negative predictive value, sensitivity and accuracy in predicting treatment outcomes in this population.","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Serfaty', 'Affiliation': ""Service d'Hépatogastroentérologie, Hôpital Hautepierre, Strasbourg, France.""}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Jacobson', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rockstroh', 'Affiliation': 'Bonn University Hospital, Bonn, Germany.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Hwang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Eliav', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haber', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",Journal of viral hepatitis,['10.1111/jvh.13037']
2913,30421537,Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.,"Glecaprevir coformulated with pibrentasvir (G/P) is approved to treat hepatitis C virus (HCV) infection and was highly efficacious in phase 2 and 3 studies. Treating HCV genotype (GT) 3 infection remains a priority, as these patients are harder to cure and at a greater risk for liver steatosis, fibrosis progression and hepatocellular carcinoma. Data were pooled from five phase 2 or 3 trials that evaluated 8-, 12- and 16-week G/P in patients with chronic HCV GT3 infection. Patients without cirrhosis or with compensated cirrhosis were either treatment-naïve or experienced with interferon- or sofosbuvir-based regimens. Safety and sustained virologic response 12 weeks post-treatment (SVR12) were assessed. The analysis included 693 patients with GT3 infection. SVR12 was achieved by 95% of treatment-naïve patients without cirrhosis receiving 8-week (198/208) and 12-week (280/294) G/P. Treatment-naïve patients with cirrhosis had a 97% (67/69) SVR12 rate with 12-week G/P. Treatment-experienced, noncirrhotic patients had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, respectively; 94% (48/51) of treatment-experienced patients with cirrhosis treated for 16 weeks achieved SVR12. No serious adverse events (AEs) were attributed to G/P; AEs leading to study drug discontinuation were rare (<1%). G/P was well-tolerated and efficacious for patients with chronic HCV GT3 infection, regardless of cirrhosis status or prior treatment experience. Eight- and 12-week durations were efficacious for treatment-naïve patients without cirrhosis and with compensated cirrhosis, respectively; 16-week G/P was efficacious in patients with prior treatment experience irrespective of cirrhosis status.",2019,"SVR12 was achieved by 95% of treatment-naïve patients without cirrhosis receiving 8-week (198/208) and 12-week (280/294) G/P. Treatment-naïve patients with cirrhosis had a 97% (67/69) SVR12 rate with 12-week G/P. Treatment-experienced, noncirrhotic patients had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, respectively; 94% (48/51) of treatment-experienced patients with cirrhosis treated for 16 weeks achieved SVR12.","['Patients without cirrhosis or with compensated cirrhosis', 'patients with chronic HCV genotype', 'patients with chronic HCV GT3 infection', '693 patients with GT3 infection']","['interferon- or sofosbuvir-based regimens', 'Glecaprevir/Pibrentasvir', 'Glecaprevir coformulated with pibrentasvir (G/P']","['SVR12', 'SVR12 rate', 'SVR12 rates', 'Safety and sustained virologic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",693.0,0.0164474,"SVR12 was achieved by 95% of treatment-naïve patients without cirrhosis receiving 8-week (198/208) and 12-week (280/294) G/P. Treatment-naïve patients with cirrhosis had a 97% (67/69) SVR12 rate with 12-week G/P. Treatment-experienced, noncirrhotic patients had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, respectively; 94% (48/51) of treatment-experienced patients with cirrhosis treated for 16 weeks achieved SVR12.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Flamm', 'Affiliation': 'Northwestern Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mutimer', 'Affiliation': 'Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Asatryan', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rockstroh', 'Affiliation': 'Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Horsmans', 'Affiliation': 'Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Kwo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, California.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Weiland', 'Affiliation': 'Karolinska University Hospital Huddinge at Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Villa', 'Affiliation': 'University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Liver Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Ryder', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre and Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Welzel', 'Affiliation': 'JW Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ruane', 'Affiliation': 'Ruane Medical & Liver Health Institute, Los Angeles, California.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': 'Institute of Liver Studies, Kings College Hospital, London, UK.'}, {'ForeName': 'Teresa I', 'Initials': 'TI', 'LastName': 'Ng', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Zhenyi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Sandra S', 'Initials': 'SS', 'LastName': 'Lovell', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kopecky-Bromberg', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Trinh', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Federico J', 'Initials': 'FJ', 'LastName': 'Mensa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wyles', 'Affiliation': 'Denver Health Medical Center, Denver, Colorado.'}]",Journal of viral hepatitis,['10.1111/jvh.13038']
2914,30466549,"Substance use outcomes in cocaine-dependent tobacco smokers: A mediation analysis exploring the role of sleep disturbance, craving, anxiety, and depression.","BACKGROUND


Sleep disturbance may play a role in cocaine use outcomes and, hence, may be a potential therapeutic target for cocaine use disorder (CUD). Research in this area, which has largely relied on resource-intensive polysomnography, would be facilitated by identifying a self-report sleep measure predictive of CUD outcomes and by a better understanding of the mechanisms by which sleep may impact CUD outcomes. This study tested the predictive validity of the Pittsburgh Sleep Quality Index (PSQI), a self-report assessment of past-month sleep quality. To better understand potential mechanisms, mediation models relating sleep disturbance to CUD outcomes were evaluated.
METHODS


This is a secondary analysis of data from cocaine-dependent (n = 290) participants in a multi-site trial evaluating smoking-cessation treatment for stimulant-dependent patients. The PSQI was collected at baseline; the outcomes of interest were cocaine and drug abstinence at end-of-treatment (weeks 9-10). Potential mediators, measured in weeks 1-8, were: cocaine craving (Brief Substance Craving Scale); and anxiety and depression symptoms (Hospital Anxiety and Depression Scale). Mediation techniques were used to evaluate mediation effects separately and jointly.
RESULTS


The majority of participants (58.3%) had baseline sleep disturbance. Sleep disturbance was not a significant predictor of end-of-treatment abstinence when regressed without consideration of mediators. Cocaine craving, anxiety, and depression were significant mediators, both separately and jointly, of an effect of baseline sleep disturbance on end-of-treatment abstinence.
CONCLUSION


This exploratory analysis suggests that there may be an indirect relationship between self-reported sleep quality and substance use outcomes in cocaine-dependent patients, mediated by craving, anxiety, and depression.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01077024.",2019,"Cocaine craving, anxiety, and depression were significant mediators, both separately and jointly, of an effect of baseline sleep disturbance on end-of-treatment abstinence.
","['data from cocaine-dependent (n\u202f=\u202f290) participants in a multi-site trial evaluating smoking-cessation treatment for stimulant-dependent patients', 'dependent tobacco smokers']",['cocaine'],"['sleep disturbance, craving, anxiety, and depression', 'Sleep disturbance', 'Pittsburgh Sleep Quality Index (PSQI), a self-report assessment of past-month sleep quality', 'baseline sleep disturbance', 'cocaine craving (Brief Substance Craving Scale); and anxiety and depression symptoms (Hospital Anxiety and Depression Scale', 'Cocaine craving, anxiety, and depression']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",290.0,0.0625039,"Cocaine craving, anxiety, and depression were significant mediators, both separately and jointly, of an effect of baseline sleep disturbance on end-of-treatment abstinence.
","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhust@uc.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.10.011']
2915,31811487,Correction to: Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial.,Revised Funding Information.,2020,Revised Funding Information.,['patients with chronic myeloid leukaemia'],['medication management service'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}]","[{'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],,0.0806075,Revised Funding Information.,"[{'ForeName': 'Bee Kim', 'Initials': 'BK', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, 47500, Subang Jaya, Selangor, Malaysia.""}, {'ForeName': 'Li-Chia', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'Kian Meng', 'Initials': 'KM', 'LastName': 'Chang', 'Affiliation': 'Department of Hematology, Ampang Hospital, 68000, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Sharmini', 'Initials': 'S', 'LastName': 'Balashanker', 'Affiliation': 'School of Pharmacy, University of Nottingham Malaysia Campus, 43500, Semenyih, Selangor, Malaysia.'}, {'ForeName': 'Ping Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia. pcbee@um.edu.my.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05212-2']
2916,32472161,Activation patterns of pelvic floor muscles in women with incontinence while running: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


Running is known to cause urinary leakage in women with stress urinary incontinence (SUI). Task-specific fiber-type recruitment while running can be estimated using wavelets. The aim of this study was to compare the effect of a new physiotherapy program including involuntary, reflexive training with a standard physiotherapy program on pelvic floor muscle (PFM) activation patterns and fiber-type recruitment behavior while running.
METHODS


In this triple-blinded randomized controlled trial, women with SUI were randomly allocated to the control group (CON), which performed a standard physiotherapy program, or the experimental group (EXP), which received additional involuntary, reflexive training. PFM electromyography (EMG) was recorded during 10 s at three running speeds and analyzed using Morse wavelets. The relative distribution of power (%) over the frequencies from 20 to 200 Hz was extracted and analyzed within six-time intervals of 30 ms. Statistical nonparametric mapping was performed to identify power spectra differences.
RESULTS


Thirty-nine (CON) and 38 (EXP) women were included. The power spectra showed no statistically significant group differences. The time intervals from 30 ms before to 30 ms after initial contact showed significantly lower intensities than the intervals from 30 to 150 ms after initial contact in the lowest and higher intensities in the highest frequencies for all running speeds and both groups.
CONCLUSIONS


Power spectra shifts toward higher frequency bands in the pre-initial contact phase could indicate a feed-forward anticipation and a muscle tuning for the expected impact of initial contact event in order to maintain continence.",2020,The power spectra showed no statistically significant group differences.,"['women with stress urinary incontinence (SUI', 'women with SUI', 'women with incontinence while running', '38 (EXP) women were included', 'Thirty-nine (CON) and']","['control group (CON), which performed a standard physiotherapy program, or the experimental group (EXP), which received additional involuntary, reflexive training', 'new physiotherapy program including involuntary, reflexive training with a standard physiotherapy program']","['PFM electromyography (EMG', 'pelvic floor muscle (PFM) activation patterns and fiber-type recruitment behavior']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0926673,The power spectra showed no statistically significant group differences.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Koenig', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Murtenstrasse 10, 3008, Bern, Switzerland. irene.koenig@bfh.ch.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Eichelberger', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Murtenstrasse 10, 3008, Bern, Switzerland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Luginbuehl', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Murtenstrasse 10, 3008, Bern, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'University Hospital and University of Bern, University Clinic of Gynecology, Bern, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lehmann', 'Affiliation': 'Department of Physiotherapy, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Taeymans', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Murtenstrasse 10, 3008, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Radlinger', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Murtenstrasse 10, 3008, Bern, Switzerland.'}]",International urogynecology journal,['10.1007/s00192-020-04334-0']
2917,32472172,Intravitreal ranibizumab alone or in combination with panretinal photocoagulation for the treatment of proliferative diabetic retinopathy with coexistent macular edema: long-term outcomes of a prospective study.,"AIMS


To compare intravitreal ranibizumab as monotherapy or in combination with panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME) in a long-term follow-up of 24 months.
METHODS


Participants in this prospective study were 47 patients with PDR and concurrent DME, who were randomized at baseline into two groups: (i) the ""ranibizumab alone"" group (n = 23), which was treated with at least 3 intravitreal ranibizumab injections as a loading phase, and (ii) the ""combination"" group (n = 24), which was treated with PRP and at least 3 intravitreal ranibizumab injections. Thereafter, all patients were followed up at a pro re nata (PRN) basis, with regular monthly monitoring for 24 months. At each visit, best corrected visual acuity (BCVA) and spectral domain-optical coherence tomography were performed, while regression of neovascularization was also recorded.
RESULTS


The ""combination"" group had better control of neovascularization and less events of vitreous hemorrhage than ranibizumab alone through the 2 years. BCVA did not differ significantly between the two groups at months 12 and 24 of the follow-up. The ""ranibizumab"" alone group presented greater reduction in central retinal thickness at month 12, which did not reach significance at month 24 compared to ""combination"" group. Greater number of injections was needed in the monotherapy group (mean 14 injections) compared to ""combination"" group (mean 11 injections) through month 24.
CONCLUSIONS


Both intravitreal ranibizumab alone or in combination with PRP could be used effectively for the treatment of PDR and coexistent DME. Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.",2020,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","['patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME', 'proliferative diabetic retinopathy with coexistent macular edema', 'Participants in this prospective study were 47 patients with PDR and concurrent DME']","['ranibizumab alone"" group', 'ranibizumab injections', 'panretinal photocoagulation (PRP', 'intravitreal ranibizumab', 'Intravitreal ranibizumab alone or in combination with panretinal photocoagulation', 'ranibizumab']","['BCVA and CRT', 'Greater number of injections', 'vitreous hemorrhage', 'central retinal thickness', 'control of neovascularization', 'BCVA', 'corrected visual acuity (BCVA) and spectral domain-optical coherence tomography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",47.0,0.0173837,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Chatziralli', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece. eirchat@yahoo.gr.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Dimitriou', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazantzis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Acta diabetologica,['10.1007/s00592-020-01548-y']
2918,32472255,The effect of radiotherapy delivery time and obturation materials on the fracture resistance of mandibular premolars.,"OBJECTIVES


This ex vivo study was performed to investigate the effect of radiotherapy (RT) delivery time on fracture resistance of mandibular premolars filled with Biodentine or gutta-percha/sealer (GPS).
MATERIALS AND METHODS


Seventy-two mandibular premolars were used in this study. Randomly selected 24 teeth were kept intact for the control groups (with and without irradiation). Then, the remaining 48 teeth were randomly assigned into 4 groups (n = 12) according to RT delivery time (irradiated before or after root canal treatment) and obturation materials as follows: Group RT + GPS, Group: GPS + RT, Group RT + Biodentine and Group Biodentine + RT. The samples were either initially endodontically treated and then irradiated or initially irradiated and then endodontically treated with one of the abovementioned materials. The samples were irradiated at 2 Gy per fraction, 5 times a week for a total dose of 60 Gy in 30 fractions over 6 weeks. The roots were embedded in self-polymerizing acrylic resin. The fracture resistance was evaluated in a universal testing machine. Data was analyzed by one-way ANOVA and Games-Howell post hoc test at p < 0.05.
RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05). The highest fracture resistance was observed in intact/non-irradiated teeth and the lowest fracture resistance in Biodentine + RT group (p < 0.05). The effect of RT delivery time was insignificant when GPS was preferred as the root canal filling material (p > 0.05); it was significant when preferring Biodentine (p < 0.05). When RT was applied to the teeth after Biodentine obturation, the fracture resistance decreased significantly compared to the teeth that were obturated with GPS after or before RT application (p < 0.05).
CONCLUSION


Both RT time and obturation materials (Biodentine or gutta-percha/sealer) affect the fracture resistance of the endodontically treated teeth.
CLINICAL RELEVANCE


Endodontic treatment could be completed with both materials after RT; however, when the endodontic treatment was initially completed and the teeth were subsequently exposed to RT, it was shown that the reinforcement effect of Biodentine decreased.",2020,"RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05).","['Seventy-two mandibular premolars', 'remaining 48 teeth', 'fracture resistance of mandibular premolars filled with Biodentine or gutta-percha/sealer (GPS', 'mandibular premolars']","['RT delivery time (irradiated before or after root canal treatment) and obturation materials as follows: Group RT + GPS, Group: GPS + RT, Group RT + Biodentine and Group Biodentine + RT', 'Biodentine + RT', 'radiotherapy', 'radiotherapy (RT']","['fracture resistance of intact teeth', 'RT delivery time', 'fracture resistance', 'root canal filling material', 'highest fracture resistance']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450439', 'cui_str': 'Obturation material'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0205250', 'cui_str': 'High'}]",24.0,0.0135154,"RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05).","[{'ForeName': 'Sevinç', 'Initials': 'S', 'LastName': 'Aktemur Türker', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Zonguldak Bülent Ecevit University, Zonguldak, Turkey. sevincaktemur@hotmail.com.'}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Kaşıkçı', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Zonguldak Bülent Ecevit University, Zonguldak, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Uzunoğlu Özyürek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Keziban', 'Initials': 'K', 'LastName': 'Olcay', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Elmas', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Zonguldak Bülent Ecevit University , Zonguldak, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03378-2']
2919,32472263,"Functional outcome after corrective osteotomy for malunion of the distal radius: a randomised, controlled, double-blind trial.","PURPOSE


The purpose of this randomised, controlled, double-blind trial was to evaluate functional outcome during the first year after corrective osteotomy for malunited distal radius fractures, with or without filling the osteotomy void.
METHOD


Patients were randomised to receive a HydroSet bone substitute or no graft. Cortical contact was maintained and stabilisation of the osteotomy was carried out with a DiPhos R- or RM Plate. To evaluate subjective functional outcome, the Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH), the Canadian Occupational Performance Measure (COPM) and the RAND-36 were used. Moreover, range of motion and grip strength were measured by blinded evaluators. Evaluations were made pre-operatively and three, six and 12 months post-operatively.
RESULTS


There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05). In both groups, there was a significant improvement at the 12-month follow-up compared with pre-operatively for the PRWE, the Q-DASH and the COPM satisfaction scores. The RAND-36 revealed no significant differences except for two domains, in which there was an improvement in the treatment group (p < 0.05). For grip strength and for range of motion in all movement directions, except dorsal extension, there was a significant improvement in both groups (p < 0.05).
CONCLUSION


There is no significant difference in functional outcome during the first year after corrective open-wedge distal radius osteotomy, where cortical contact is maintained, regardless of whether or not bone substitute to fill the void is used.",2020,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"['malunion of the distal radius', 'Patients']","['HydroSet bone substitute or no graft', 'corrective osteotomy']","['range of motion or grip strength', 'functional outcome', 'Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire ', 'range of motion and grip strength', 'COPM satisfaction scores', 'Canadian Occupational Performance Measure (COPM']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",,0.070651,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Andreasson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Ingrid.f.andreasson@vgregion.se.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Kjellby-Wendt', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fagevik Olsén', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Aurell', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ullman', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jón', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",International orthopaedics,['10.1007/s00264-020-04605-x']
2920,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
2921,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND


To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels.
METHODS


Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period.
RESULTS


Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status.
CONCLUSIONS


Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143']
2922,32473591,Acute and Short-Term Response to Different Loading Conditions During Resisted Sprint Training.,"PURPOSE


To analyze the acute and short-term physical and metabolic responses to resisted sprint training with 5 different loading conditions (0%, 20%, 40%, 60%, and 80% body mass).
METHODS


Fifteen male participants performed 8 × 20-m sprints with 2-minute rests between sprints with 5 different loading conditions. Subjects performed a battery of tests (creatine kinase and lactate concentrations, countermovement jump, 20-m sprint, and isokinetic knee extension and flexion contractions) at 3 different time points (preexercise [PRE], postexercise [POST], and 24-h postexercise [POST24H]).
RESULTS


Results revealed significant increases in blood lactate for all loading conditions; however, as sled loadings increased, higher blood lactate concentrations and increments in sprint times during the training session were observed. Significant increases in creatine kinase concentration were observed from PRE to POST24H for all loading conditions. Concerning physical performance, significant decreases in countermovement-jump height from PRE to POST were found for all loading conditions. In addition, significant decreases in 20-m sprint performance from PRE to POST were observed for 0% (P = .05) and 80% (P = .02). No significant differences with PRE were observed for the physical-performance variables at POST24H, except for 20% load, which induced a significant decrease in mean power during knee flexion (P = .03).
CONCLUSIONS


These results suggest that the higher the load used during resisted sprint training, the higher the physical-performance impairments and metabolic response produced, although all loading conditions led to a complete recovery of sprint performance at POST24H.",2020,"Concerning physical performance, significant decreases in countermovement-jump height from PRE to POST were found for all loading conditions.",['Fifteen male participants performed 8 × 20-m sprints with 2-minute rests between sprints with 5 different loading conditions'],"['Loading Conditions', 'resisted sprint training']","['blood lactate concentrations', 'creatine kinase concentration', 'PRE', 'blood lactate', 'battery of tests (creatine kinase and lactate concentrations, countermovement jump, 20-m sprint, and isokinetic knee extension and flexion contractions', '20-m sprint performance', 'countermovement-jump height', 'sled loadings', 'time points (preexercise [PRE], postexercise [POST], and 24-h postexercise [POST24H', 'mean power during knee flexion']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",15.0,0.0276825,"Concerning physical performance, significant decreases in countermovement-jump height from PRE to POST were found for all loading conditions.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Bachero-Mena', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez-Moreno', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': ''}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Sañudo', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0723']
2923,32473592,"Effect of Tethered Swimming as Postactivation Potentiation on Swimming Performance and Technical, Hemophysiological, and Psychophysiological Variables in Adolescent Swimmers.","OBJECTIVES


To investigate whether tethered swimming (TS) performed 8 minutes before a 50-m freestyle swimming sprint could be an effective postactivation potentiation method to improve performance in young swimmers.
METHODS


Fourteen regional-level male adolescent swimmers (age 13.0 [2.0] y; height 161.1 [12.4] cm; body mass 52.5 [9.5] kg) underwent 2 trial conditions in a randomized and counterbalanced order (1 experimental [TS], 1 control) on different days. During the experimental session, the participants performed a standard warm-up of 1200 m followed by a TS exercise, which consisted of 3 × 10-second maximal efforts of TS with 1-minute rests between bouts. In the control condition, the warm-up phase was immediately followed by 200 m at a moderate pace (same duration as the TS in the experimental session). Performance (time trial); biomechanical (stroke length), physiological (blood lactate concentrations), and psychophysiological (ratings of perceived exertion) variables; and countermovement-jump (CMJ) flight time were collected.
RESULTS


TS warm-up had no significant effect on 50-m swimming performance (P = .27), postexercise ratings of perceived exertion, stroke length, or CMJ flight time (P ≥ .05). Blood lactate concentrations significantly increased at the end of the warm-up in the TS condition only (interaction effect: F1.91,29.91 = 4.91, P = .01, η2 = .27) and after the 50-m trial in both conditions (F1.57,20.41 = 62.39, P = .001, η2 = .82).
CONCLUSIONS


The present study demonstrated that 3 × 10-second TS exercises performed 8 minutes prior to the event did not affect ratings of perceived exertion, stroke length, or CMJ flight time. In addition, tethered swimming did not affect 50-m freestyle sprint performance in young swimmers.",2020,"RESULTS


TS warm-up had no significant effect on 50-m swimming performance (P = .27), postexercise ratings of perceived exertion, stroke length, or CMJ flight time (P ≥ .05).","['young swimmers', 'Adolescent Swimmers', 'Fourteen regional-level male adolescent swimmers (age 13.0 [2.0]\xa0y; height 161.1 [12.4]\xa0cm; body mass 52.5 [9.5]\xa0kg']","['Tethered Swimming as Postactivation Potentiation', 'standard warm-up of 1200\xa0m followed by a TS exercise', 'tethered swimming (TS']","['Swimming Performance and Technical, Hemophysiological, and Psychophysiological Variables', 'postexercise ratings of perceived exertion, stroke length, or CMJ flight time', 'Performance (time trial); biomechanical (stroke length), physiological (blood lactate concentrations), and psychophysiological (ratings of perceived exertion) variables; and countermovement-jump (CMJ) flight time', 'Blood lactate concentrations', '50-m freestyle sprint performance', '50-m swimming performance', 'ratings of perceived exertion, stroke length, or CMJ flight time']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}]","[{'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0518041,"RESULTS


TS warm-up had no significant effect on 50-m swimming performance (P = .27), postexercise ratings of perceived exertion, stroke length, or CMJ flight time (P ≥ .05).","[{'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Abbes', 'Affiliation': ''}, {'ForeName': 'Monoem', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': ''}, {'ForeName': 'Khalid W', 'Initials': 'KW', 'LastName': 'Bibi', 'Affiliation': ''}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Mujika', 'Affiliation': ''}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Chamari', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0669']
2924,30168613,"Hepatocellular Carcinoma Detection by Plasma Methylated DNA: Discovery, Phase I Pilot, and Phase II Clinical Validation.","Early detection improves hepatocellular carcinoma (HCC) outcomes, but better noninvasive surveillance tools are needed. We aimed to identify and validate methylated DNA markers (MDMs) for HCC detection. Reduced representation bisulfite sequencing was performed on DNA extracted from 18 HCC and 35 control tissues. Candidate MDMs were confirmed by quantitative methylation-specific PCR in DNA from independent tissues (74 HCC, 29 controls). A phase I plasma pilot incorporated quantitative allele-specific real-time target and signal amplification assays on independent plasma-extracted DNA from 21 HCC cases and 30 controls with cirrhosis. A phase II plasma study was then performed in 95 HCC cases, 51 controls with cirrhosis, and 98 healthy controls using target enrichment long-probe quantitative amplified signal (TELQAS) assays. Recursive partitioning identified best MDM combinations. The entire MDM panel was statistically cross-validated by randomly splitting the data 2:1 for training and testing. Random forest (rForest) regression models performed on the training set predicted disease status in the testing set; median areas under the receiver operating characteristics curve (AUCs; and 95% confidence interval [CI]) were reported after 500 iterations. In phase II, a six-marker MDM panel (homeobox A1 [HOXA1], empty spiracles homeobox 1 [EMX1], AK055957, endothelin-converting enzyme 1 [ECE1], phosphofructokinase [PFKP], and C-type lectin domain containing 11A [CLEC11A]) normalized by beta-1,3-galactosyltransferase 6 (B3GALT6) level yielded a best-fit AUC of 0.96 (95% CI, 0.93-0.99) with HCC sensitivity of 95% (88%-98%) at specificity of 92% (86%-96%). The panel detected 3 of 4 (75%) stage 0, 39 of 42 (93%) stage A, 13 of 14 (93%) stage B, 28 of 28 (100%) stage C, and 7 of 7 (100%) stage D HCCs. The AUC value for alpha-fetoprotein (AFP) was 0.80 (0.74-0.87) compared to 0.94 (0.9-0.97) for the cross-validated MDM panel (P < 0.0001). Conclusion: MDMs identified in this study proved to accurately detect HCC by plasma testing. Further optimization and clinical testing of this promising approach are indicated.",2019,The AUC value for alpha-fetoprotein (AFP) was 0.80 (0.74-0.87) compared to 0.94 (0.9-0.97) for the cross-validated MDM panel (P ,"['21 HCC cases and 30 controls with cirrhosis', '95 HCC cases, 51 controls with cirrhosis, and 98 healthy controls using target enrichment long-probe quantitative amplified signal (TELQAS) assays']",[],"['HCC sensitivity', 'hepatocellular carcinoma (HCC) outcomes', 'AUC value for alpha-fetoprotein (AFP']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",[],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]",95.0,0.0438544,The AUC value for alpha-fetoprotein (AFP) was 0.80 (0.74-0.87) compared to 0.94 (0.9-0.97) for the cross-validated MDM panel (P ,"[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kisiel', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Dukek', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Reddappa', 'Initials': 'R', 'LastName': 'V S R Kanipakam', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Hassan M', 'Initials': 'HM', 'LastName': 'Ghoz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Tracy C', 'Initials': 'TC', 'LastName': 'Yab', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Calise K', 'Initials': 'CK', 'LastName': 'Berger', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Taylor', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Foote', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nasra H', 'Initials': 'NH', 'LastName': 'Giama', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kristeen', 'Initials': 'K', 'LastName': 'Onyirioha', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdallah', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kelli N', 'Initials': 'KN', 'LastName': 'Burger', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Seth W', 'Initials': 'SW', 'LastName': 'Slettedahl', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Mahoney', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Smyrk', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Lewis', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giakoumopoulos', 'Affiliation': 'Exact Sciences Development Company, LLC, Madison, WI.'}, {'ForeName': 'Hatim T', 'Initials': 'HT', 'LastName': 'Allawi', 'Affiliation': 'Exact Sciences Development Company, LLC, Madison, WI.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Lidgard', 'Affiliation': 'Exact Sciences Development Company, LLC, Madison, WI.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Roberts', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ahlquist', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30244']
2925,30383918,Characterization of changes in intrahepatic immune cell populations during HCV treatment with sofosbuvir and ribavirin.,"Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals (DAAs) results in a sustained virologic response (SVR) in most patients. While highly efficacious, ~3%-5% of patients do not achieve SVR despite having virus that appears susceptible. It is unclear whether host factors contribute to treatment failures, although innate and adaptive immunity may play a role. Previous studies showed that after DAA treatment, the composition of intrahepatic immune cells does not normalize relative to healthy volunteers, even in cases where SVR is achieved. We used paired pre- and post-treatment liver biopsies from 13 patients treated with sofosbuvir and ribavirin, 4 of whom relapsed, to analyse intracellular immune changes during DAA treatment and explore correlations with inflammation and treatment outcome. We performed single marker immunohistochemistry followed by electronic image capture, manual annotation of parenchymal and non-parenchymal regions, and quantitative image analysis. The predominant cellular change during treatment was a decrease in CD8+ cellular density in both parenchymal and non-parenchymal regions. CD68+ Kupffer cell density correlated with hepatic inflammation (AST, ALT) pre-treatment, but did not change during treatment. CD4+ cellular density decreased in non-parenchymal regions and, intriguingly, was lower pre-treatment in subjects who eventually relapsed. Other cellular markers (CD56, CD20), as well as markers of apoptosis (TIA-1) and activated stellate cells, did not change significantly during treatment or differ by treatment outcome. The predominant intrahepatic cellular change during DAA treatment of chronic HCV infection is a reduction in CD8+ cellular density, but this did not correlate with treatment outcome.",2019,The predominant cellular change during treatment was a decrease in CD8+ cellular density in both parenchymal and non-parenchymal regions.,[],"['sofosbuvir and ribavirin', 'direct-acting antivirals (DAAs', 'ribavirin']","['CD4+ cellular density', 'CD8+ cellular density', 'markers of apoptosis (TIA-1) and activated stellate cells']",[],"[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C1429678', 'cui_str': 'TIA1 protein, human'}, {'cui': 'C0205141', 'cui_str': 'Stellate'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0262559,The predominant cellular change during treatment was a decrease in CD8+ cellular density in both parenchymal and non-parenchymal regions.,"[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Orr', 'Affiliation': 'Division of Infectious Diseases, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Aartun', 'Affiliation': 'Department of Oral Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Masur', 'Affiliation': 'Critical Care Medicine Department, NIH Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Kottilil', 'Affiliation': 'Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Meissner', 'Affiliation': 'Division of Infectious Diseases, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of viral hepatitis,['10.1111/jvh.13034']
2926,31242943,Higher baseline global leukocyte DNA methylation is associated with MTX non-response in early RA patients.,"BACKGROUND


Low-dose methotrexate (MTX) is the first-line therapy in early rheumatoid arthritis (eRA). Up to 40% of eRA patients do not benefit from MTX therapy. MTX has been shown to inhibit one-carbon metabolism, which is involved in the donation of methyl groups. In this study, we investigate baseline global DNA methylation and changes in DNA methylation during treatment in relation to clinical non-response after 3 months of MTX treatment.
METHODS


Two hundred ninety-four blood samples were collected from the Treatment in the Rotterdam Early Arthritis Cohort (tREACH, ISRCTN26791028), a multicenter, stratified single-blind clinical trial of eRA patients. Global DNA (hydroxy)methylation was quantified using liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) and validated with a global DNA LINE-1 methylation technique. MTX response was determined as ΔDAS28. Additionally, patients were stratified into two response groups according to the European League Against Rheumatism (EULAR) response criteria. Associations between global DNA methylation and response were examined using univariate regression models adjusted for baseline DAS28, baseline erythrocyte folate levels, and body mass index (BMI).
RESULTS


Higher baseline global DNA methylation was associated with less decrease of DAS28 (β = 0.15, p = 0.013) and with MTX non-response (OR = 0.010, 95% CI = 0.001-0.188). This result was validated in LINE-1 elements (β = 0.22, p = 0.026). Changes in global DNA (hydroxy)methylation were not associated with MTX response over 3 months.
CONCLUSIONS


These results show that higher baseline global DNA methylation in treatment naïve eRA patients is associated with decreased clinical response after 3 months of treatment of eRA patients and can be further evaluated as a predictor for MTX therapy non-response.
TRIAL REGISTRATION


ISRCTN, ISRCTN26791028 , registered 23 August 2007-retrospectively registered.",2019,"RESULTS


Higher baseline global DNA methylation was associated with less decrease of DAS28 (β = 0.15, p = 0.013) and with MTX non-response (OR = 0.010, 95% CI = 0.001-0.188).","['early RA patients', 'Two hundred ninety-four blood samples']","['MTX', 'methotrexate (MTX']","['erythrocyte folate levels, and body mass index (BMI', 'European League Against Rheumatism (EULAR) response criteria', 'global DNA (hydroxy)methylation', 'DAS28', 'clinical response', 'MTX response']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",,0.0880037,"RESULTS


Higher baseline global DNA methylation was associated with less decrease of DAS28 (β = 0.15, p = 0.013) and with MTX non-response (OR = 0.010, 95% CI = 0.001-0.188).","[{'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Gosselt', 'Affiliation': 'Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Bertrand D', 'Initials': 'BD', 'LastName': 'van Zelst', 'Affiliation': 'Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Maurits C F J', 'Initials': 'MCFJ', 'LastName': 'de Rotte', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, Univ of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Johanna M W', 'Initials': 'JMW', 'LastName': 'Hazes', 'Affiliation': 'Department of Rheumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Jonge', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Heil', 'Affiliation': 'Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. s.heil@erasmusmc.nl.'}]",Arthritis research & therapy,['10.1186/s13075-019-1936-5']
2927,31267360,Infiltrating and peripheral immune cell analysis in advanced gastric cancer according to the Lauren classification and its prognostic significance.,"BACKGROUND


The correlation between immune cells and the Lauren classification subtypes and their prognostic impact in advanced gastric cancer (AGC) are unknown.
METHODS


Circulating natural killer (NK) cells, CD4 +  and CD8 +  T cells, regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs) were quantified in peripheral blood mononuclear cells (PBMCs) from 67 patients with untreated AGC enrolled in the PRODIGE 17-ACCORD 20 trial. CD56 +  cells (NK), CD8 + , and FoxP3 +  (Treg) tumor-infiltrating lymphocytes (TILs) were assessed in tumor samples.
RESULTS


Circulating NK and Treg proportions were significantly lower in patients with diffuse/mixed-type AGC (n = 27) than those with intestinal type (n = 40; median 6.3% vs 11.5%; p = 0.02 and median 3.3% vs 5.2%; p = 0.03, respectively). Proportions of circulating MDSC, CD4 +  and CD8 +  T cells were not associated with one pathological type. Among tumor-infiltrating cells, CD8 +  T cells, but not NK or FoxP3 +  cells, were significantly lower in diffuse/mixed-type AGC (median 21 vs 59 cells/field; p = 0.009). Patients with high circulating NK cell counts (> 17%) had a better overall survival than those with < 17% (HR 0.40; 95% CI [0.15-1.06]; p = 0.04). Patients with high CD8 +  TIL counts (> 31 cells/field) had significantly longer overall survival (HR 0.44; 95% CI [0.21-0.92]; p = 0.02). The prognostic value of CD8 +  TILs was maintained after adjustment for confounding factors, including the Lauren classification (HR = 0.42; 95% CI [0.18-0.96]; p = 0.039).
CONCLUSION


Diffuse/mixed-type AGC has lower rates of CD8 +  TILs and circulating NK cells and Tregs than the intestinal type. This ""cold tumor"" phenotype may be associated with a worse outcome.",2020,Patients with high circulating NK cell counts (> 17%) had a better overall survival than those with < 17% (HR 0.40; 95% CI [0.15-1.06]; p = 0.04).,"['67 patients with untreated AGC enrolled in the PRODIGE 17-ACCORD 20 trial', 'advanced gastric cancer', 'advanced gastric cancer (AGC']",[],"['overall survival', 'CD56 +  cells (NK), CD8 + , and FoxP3 + \u2009(Treg) tumor-infiltrating lymphocytes (TILs', 'rates of CD8 +  TILs and circulating NK cells', 'Proportions of circulating MDSC, CD4 +  and CD8 +  T cells', 'Circulating natural killer (NK) cells, CD4 +  and CD8 +  T cells, regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0882903', 'cui_str': 'Cell positive for CD56 antigen'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C4277543', 'cui_str': 'MDSCs'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}]",67.0,0.10835,Patients with high circulating NK cell counts (> 17%) had a better overall survival than those with < 17% (HR 0.40; 95% CI [0.15-1.06]; p = 0.04).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Pernot', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France. simon.pernot@aphp.fr.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Terme', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Radosevic-Robin', 'Affiliation': 'Department of Biopathology, Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': ""Biometrics Unit, Institut du Cancer Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Badoual', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Marcheteau', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}, {'ForeName': 'Fréderique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Biopathology, Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'CHU Robert Debré, Reims, France.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancérologie de l'Ouest-Site René Gauducheau, Saint Herblain, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Francois', 'Affiliation': 'Centre Antoine-Lacassagne, Nice, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Samalin', 'Affiliation': ""Institut du Cancer Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Baptiste Bachet', 'Affiliation': 'Pitié Salpétrière Hospital, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Medical Oncology Unit, CHU Minjoz, Besancon, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Boige', 'Affiliation': 'Département de Médecine Oncologique, Gustave Roussy, Université Paris-Saclay, 94805, Villejuif, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Voron', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stanbury', 'Affiliation': 'UNICANCER, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tartour', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Biometrics Unit, Institut du Cancer Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Département de Médecine Oncologique, Gustave Roussy, Université Paris-Saclay, 94805, Villejuif, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Université de Paris, PARCC, INSERM, 75015, Paris, France.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-019-00983-3']
2928,31385562,Efficacy and safety of a novel antimicrobial preoperative skin preparation.,"OBJECTIVE


Alternatives to skin preparation with conventional preoperative antiseptics are required because of adverse reactions and the potential emergence of resistance. Here, we present 2 phase 2 studies of ZuraGard (ZG), a novel formulation of isopropyl alcohol and functional excipients developed for preoperative skin antisepsis.
METHODS


Microbial skin flora on abdominal and inguinal sites in healthy volunteers were quantitatively assessed following application of ZG versus a negative control (ZV) and a chlorhexidine/alcohol preparation, Chloraprep (CP). In trial 1, ZG administered for both recommended and abbreviated application times was compared with CP and ZV via bacterial reductions at 10 minutes, and 6 hours, 12 hours, and 24 hours following application. In trial 2, the 10-minute postapplication responder rates (RRs) for ZG, participants with abdominal ≥2 log10 per cm2, and inguinal ≥3 log10 per cm2 reductions in colony-forming units (CFU) were compared to RRs of participants treated with CP.
RESULTS


In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively. Qualitatively similar reductions were observed for the abbreviated ZG application time and all CP applications. Application of ZV was ineffective. In trial 2, 10-minute RRs for ZG and CP exceeded 90% at abdominal sites. At inguinal sites, RRs were 83.3% for ZG and 86.7% for CP. No skin irritation or other adverse events were observed.
CONCLUSIONS


ZG matched CP efficacy under these experimental conditions with immediate and persistent microbial reductions, including abbreviated application times. Further clinical studies of this novel preoperative antiseptic are merited.",2019,"In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively.",['Microbial skin flora on abdominal and inguinal sites in healthy volunteers'],"['ZG', 'isopropyl alcohol and functional excipients', 'novel antimicrobial preoperative skin preparation', 'ZG versus a negative control (ZV) and a chlorhexidine/alcohol preparation, Chloraprep (CP', 'ZV', 'ZuraGard (ZG']","['Efficacy and safety', 'skin irritation or other adverse events', 'mean bacterial counts']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",,0.0213631,"In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Aurora E', 'Initials': 'AE', 'LastName': 'Pop-Vicas', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hedberg', 'Affiliation': 'Department of Neuroscience, Albert Einstein College of Medicine, New York, New York.'}, {'ForeName': 'Trish M', 'Initials': 'TM', 'LastName': 'Perl', 'Affiliation': 'Division of Infectious Diseases and Geographic Medicine, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.200']
2929,32471872,Olaparib Makes OS Gains in Ovarian Cancer.,"Olaparib has solidified its place as a standard maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer who have  BRCA  mutations. In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.",2020,"In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.","['Ovarian Cancer', 'patients with platinum-sensitive relapsed ovarian cancer who have  BRCA  mutations']","['placebo', 'Olaparib']",['overall survival'],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.129422,"In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-048']
2930,32472292,"The effects of taurine supplementation on glycemic control and serum lipid profile in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.","Previous studies have suggested that taurine has hypoglycemic and hypolipidemic effects on experimental diabetic models. Therefore, this clinical trial was designed to explore the impacts of taurine supplementation on glycemic control and lipid profile in the patients with T2DM. This study was conducted on 45 patients with T2DM in Tabriz Sheikhor-raees Polyclinic and Imam-Reza Hospital Endocrine Center. Subjects were randomly divided into taurine and placebo groups. Accordingly, the taurine group (n = 23) received taurine 3000 mg/daily and the placebo group (n = 22) took crystalline microcellulose/daily for the duration of 8 weeks. At baseline and after the trial completion, fasting blood samples were obtained from the patients to assess the glycemic indicators and lipid profile. Independent t test, paired t test, Pearson's correlation, and analysis of covariance was used for analysis. At the end of the study, levels of FBS (p = 0.01), insulin (p = 0.01), HOMA-IR (p = 0.003), TC (p = 0.013), and LDL-C (p = 0.041) significantly decreased in the taurine group compared to the placebo group. In addition, there was no significant changes in HbA1c, triglyceride, HDL-C, anthropometric indicators or dietary intakes by passing 8 weeks from the intervention. In conclusion, the findings of the current study indicated that taurine supplementation (3000 mg/day) for 8 weeks could improve the glycemic indexes and lipid profiles including TC and LDL-C in the patients with T2DM.",2020,"At the end of the study, levels of FBS (p = 0.01), insulin (p = 0.01), HOMA-IR (p = 0.003), TC (p = 0.013), and LDL-C (p = 0.041) significantly decreased in the taurine group compared to the placebo group.","['patients with T2DM', '45 patients with T2DM in Tabriz Sheikhor-raees Polyclinic and Imam-Reza Hospital Endocrine Center', 'patients with type 2 diabetes']","['taurine', 'taurine 3000\xa0mg/daily and the placebo', 'taurine supplementation', 'taurine and placebo', 'placebo']","['fasting blood samples', 'HOMA-IR', 'HbA1c, triglyceride, HDL-C, anthropometric indicators or dietary intakes', 'glycemic indexes and lipid profiles including TC and LDL-C', 'levels of FBS', 'glycemic control and serum lipid profile', 'glycemic control and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",45.0,0.143721,"At the end of the study, levels of FBS (p = 0.01), insulin (p = 0.01), HOMA-IR (p = 0.003), TC (p = 0.013), and LDL-C (p = 0.041) significantly decreased in the taurine group compared to the placebo group.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Maleki', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esmaeili', 'Affiliation': 'Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mahdavi', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. mahdavir@tbzmed.ac.ir.'}]",Amino acids,['10.1007/s00726-020-02859-8']
2931,32472296,Carotid plaques in adult rheumatoid arthritis patients; association with paroxonase 1 enzymatic activity and Q192R paroxonase 1 gene polymorphism.,"Paroxonase 1 (PON 1) enzymatic activity and Q192R PON polymorphism has been implicated with greater cardiovascular risk in general population. Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized with increased inflammatory markers leading to increased cardiovascular morbidity. The aim of the work was to study association between PON1 enzymatic activity & gene polymorphism with carotid plaques in RA patients. This case-control study was carried out at Zagazig University Hospitals on 99 subjects divided randomly into two groups; 48 RA patients and 51 controls. RA patients fulfilled the revised 2010 EULAR/ACR classification criteria of RA. All patients were subjected to history taking, clinical evaluation, laboratory investigations & plain X-rays. Carotid intima-media thickness (CIMT) and PON1 enzyme assay & genotyping were done for both groups. PON1 enzyme levels were significantly higher in patients than controls. Also, there was a significant negative correlation of PON1 enzyme activity with increased CIMT & plaques. The cut-off value of PON1 enzyme level that had the highest CVD prediction was 4.2 U/ml. Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype. In RA patients, decreased serum PON1 enzymatic activity and QQ genotyping of Q192R PON polymorphism was associated with increased CIMT & plaques. Serum PON1 could be a good marker for atherosclerosis prediction in RA patients at cutoff 4.2 U/ml.",2020,"Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype.","['adult rheumatoid arthritis patients', 'RA patients', 'Zagazig University Hospitals on 99 subjects divided randomly into two groups; 48 RA patients and 51 controls']",[],"['serum PON1 enzymatic activity and QQ genotyping of Q192R PON polymorphism', 'PON1 enzyme levels', 'Carotid plaques', 'PON1 enzyme activity', 'lowest PON1 activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",99.0,0.0203109,"Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype.","[{'ForeName': 'Essam Tawfik', 'Initials': 'ET', 'LastName': 'Atwa', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Atef Goda', 'Initials': 'AG', 'LastName': 'Hussin', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mona Rabie', 'Initials': 'MR', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Heba Fouad', 'Initials': 'HF', 'LastName': 'Pasha', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Hammad', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt. Marwahany22@hotmail.com.'}]",Molecular biology reports,['10.1007/s11033-020-05558-5']
2932,32472307,Long-term outcome of patients with ST-segment elevation myocardial infarction treated with low-dose intracoronary thrombolysis during primary percutaneous coronary intervention: the 5-year results of the DISSOLUTION Trial.,"We tested the hypothesis that adjunctive thrombolysis at time of primary percutaneous coronary intervention (PCI) may affect favourably the long-term outcome of patients with ST elevation myocardial infarction (STEMI). To this end, we undertook a substudy of the DISSOLUTION (Delivery of thrombolytIcs before thrombectomy in patientS with ST-segment elevatiOn myocardiaL infarction Undergoing primary percuTaneous coronary interventION) trial. A total of 95 patients were randomized to local delivery of urokinase (n = 48) or placebo (n = 47). After PCI, a greater proportion of patients receiving urokinase had an improvement in myocardial perfusion, as indicated by a significantly higher final Thrombolysis in myocardial infarction (TIMI) grade 3, myocardial blush grade, and 60-min ST-segment resolution > 70%, as well as lower corrected TIMI frame count. At 1-year echocardiography, urokinase-treated patients exhibited significantly lower LV dimension, as well as higher LV ejection fraction and wall motion score index as compared with placebo-treated patients. At 5 years, major acute cardiovascular events (MACEs) were significantly less common in the urokinase group (P = 0.023), mainly due to a lower occurrence of hospitalisation for heart failure (P = 0.038). Multivariate analysis showed that factors independently associated with 5-year occurrence of MACEs were LV remodelling at 1-year echocardiography (P = 0.0001), 1-year LV ejection fraction (P = 0.0001), TIMI grade flow 0-2 (P = 0.0019), and age at time of PCI (P = 0.0173). In conclusion, low-dose intracoronary urokinase during primary PCI is associated with a more favourable 5-year outcome of patients with STEMI.",2020,"At 5 years, major acute cardiovascular events (MACEs) were significantly less common in the urokinase group (P = 0.023), mainly due to a lower occurrence of hospitalisation for heart failure (P = 0.038).","['patients with ST-segment elevation myocardial infarction treated with', 'primary percutaneous coronary intervention', 'patientS with ST-segment elevatiOn myocardiaL infarction Undergoing primary percuTaneous coronary interventION) trial', '95 patients', 'patients with STEMI', 'patients with ST elevation myocardial infarction (STEMI']","['urokinase (n\u2009=\u200948) or placebo', 'low-dose intracoronary thrombolysis']","['LV dimension', 'occurrence of hospitalisation for heart failure', 'final Thrombolysis in myocardial infarction (TIMI) grade 3, myocardial blush grade, and 60-min ST-segment resolution', 'TIMI grade flow', '1-year LV ejection fraction', 'LV ejection fraction and wall motion score index', 'major acute cardiovascular events (MACEs', 'myocardial perfusion', '5-year occurrence of MACEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}]",95.0,0.10588,"At 5 years, major acute cardiovascular events (MACEs) were significantly less common in the urokinase group (P = 0.023), mainly due to a lower occurrence of hospitalisation for heart failure (P = 0.038).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pelliccia', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy. f.pelliccia@mclink.it.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Greco', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Viceconte', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Schiariti', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gaudio', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02157-w']
2933,32472340,Computerized occlusal analysis of Essix and Hawley retainers used during the retention phase: a controlled clinical trial.,"AIM


The aim of this study was to evaluate the occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan III (Tekscan Inc., South Boston, MA, USA) analysis.
MATERIALS AND METHODS


A total of 35 subjects were randomly assigned to one of the retention groups following fixed orthodontic treatment. While 18 of these subjects were provided with Essix retainers, 17 were given Hawley retainers. Computerized occlusal analysis of the patients' dentitions was performed using T‑Scan III. The evaluations were made after debonding (T0) and at month 3 (T1), month 6 (T2) and 1 year (T3) after the retention phase.
RESULTS


The changes in OFD were significant only in the Hawley group for the left/right half jaws and the right posterior quadrants when comparing the T2-T3 time interval. Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals. The changes in ITF were insignificant within groups, but significant between the groups for tooth 11 and 22. Although there was an increase observed in OSA for both groups, the difference between the groups was insignificant. However, the OSA increase in the Essix group for the left/right anterior quadrants was significant only for the T0-T2 and the T0-T3 time intervals, while in both groups, for the posterior left quadrant, the OSA was insignificant only for the T0-T1 time interval.
CONCLUSIONS


Although OSA increased when using both retention appliances, OFD did not change.",2020,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.",['A\xa0total of 35\xa0subjects'],['OSA'],"['changes in OFD', 'OSA increase', 'changes in ITF', 'occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan\xa0III (Tekscan Inc., South Boston, MA, USA) analysis', 'OSA']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0329424,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.","[{'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Alkan', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yüzüncü Yıl University, Van, Turkey. yesimkaya82@hotmail.com.'}, {'ForeName': 'Sıddık', 'Initials': 'S', 'LastName': 'Keskin', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00236-4']
2934,32472628,Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke.,"OBJECTIVE


The objective of this study was to investigate the safety and efficacy of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in the treatment of acute ischemic stroke (AIS).
METHODS


Patients with AIS who underwent IVT were enrolled and 1:1 randomized to the RIC group and sham-RIC group in this study. RIC (or sham-RIC) was performed twice within 6-24 h of IVT. The subjects in the two groups were followed up for 90 days. The safety outcome included the ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24 h after IVT, and laboratory tests 24 h after IVT. The efficacy outcome included the modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP) tested 24 h after IVT.
RESULTS


Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited. No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups. In addition, there was no significant difference in mRS score and NIHSS score during the follow-up between groups. However, patients in the RIC group exhibited a significant lower level of hs-CRP compared with the control group (P = 0.048).
INTERPRETATION


RIC combined with IVT is safe in the treatment of AIS. The neuroprotective and anti-inflammatory effects of this therapy warrant further study on a larger scale.",2020,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","['acute ischemic stroke', 'acute ischemic stroke (AIS', 'Patients with AIS who underwent', 'Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited']","['RIC (or sham-RIC', 'RIC group and sham-RIC', 'IVT', 'remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT', 'Remote ischemic conditioning combined with intravenous thrombolysis']","['ratio of HT, adverse events, blood pressure, coagulation function or liver function', 'mRS score and NIHSS score', 'safety and efficacy', 'modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP', 'level of hs-CRP', 'ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24\xa0h after IVT, and laboratory tests 24\xa0h after IVT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",,0.0585417,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","[{'ForeName': 'Yao-De', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Zhen-Ni', 'Initials': 'ZN', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Reziya', 'Initials': 'R', 'LastName': 'Abuduxukuer', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51063']
2935,32472663,Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section.,"OBJECTIVES


To explore the effects and mechanisms of transcutaneous electrical acustimulation (TEA) on postoperative recovery after cesarean section (CS).
MATERIALS AND METHODS


A total of 108 women who underwent CS were randomized to receive TEA or sham-TEA. Four hours after CS, electrogastrogram (EGG) and electrocardiogram (ECG) were recorded for 30 min to assess gastric slow waves and autonomic functions, respectively. TEA at ST36 or sham-TEA at non-acupoints was performed for one hour right after recording ECG and EGG and then twice daily from postoperative days (POD) 1 to 3. In the morning of POD4, the EGG and ECG were recorded again for 30 min.
RESULTS


TEA enhanced postoperative recovery associated with lower GI motility, reflected as a reduction in time of first flatus (p = 0.002) and time of first defecation (p < 0.001), an increase in the Bristol stool score (p < 0.001) and the number of SBMs (p < 0.001) in comparison with sham-TEA. TEA reduced symptoms associated with upper GI motility, including a reduction in time to resume semifluid (p = 0.008), and the total score of loss of appetite (p = 0.003) and belching (p = 0.038) from POD1 to POD3. Physiologically, TEA but not sham-TEA increased the percentage of normal gastric slow waves on POD4 compared with POD0 (p = 0.001). TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001). TEA but not sham-TEA increased vagal activity (p = 0.013) and decreased sympathetic activity (p = 0.013) on POD4 compared with POD0. Two factors were found to be independent predictors of shortened time of the first defecation: the use of TEA and a shorter surgical duration.
CONCLUSIONS


Needless non-invasive TEA at ST36 is effective in promoting both lower and upper GI symptoms after CS by enhancing vagal and suppressing sympathetic activities.",2020,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"['after cesarean section (CS', '108 women who underwent CS']","['transcutaneous electrical acustimulation (TEA', 'TEA', 'TEA at ST36 or sham-TEA', 'TEA or sham-TEA', 'Transcutaneous Electrical Acustimulation']","['Postoperative Recovery', 'number of SBMs', 'sympathetic activity', 'visual analogue scale (VAS) pain score from POD1 to POD3', 'postoperative recovery', 'vagal activity', 'Bristol stool score', 'percentage of normal gastric slow waves on POD4', 'time to resume semifluid', 'belching', 'total score of loss of appetite', 'time of first flatus', 'electrogastrogram (EGG) and electrocardiogram (ECG', 'time of first defecation']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C4523797', 'cui_str': 'Electrogastrogram'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",108.0,0.194432,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"[{'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Yinfang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Jingfei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13178']
2936,32472742,"Efficacy of NEPA, a fixed antiemetic combination of netupitant and palonosetron, vs a 3-day aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese patients receiving highly emetogenic chemotherapy (HEC) in a randomized Phase 3 study.","NEPA is the only fixed combination antiemetic, comprised of an NK 1  RA (netupitant) and a 5-HT 3  RA (palonosetron). In the first head-to-head trial to compare NK 1  RA-containing regimens, a single oral dose of NEPA was non-inferior to a 3-day aprepitant/granisetron (APR/GRAN) regimen for the primary endpoint of overall (0-120 hours) complete response (no emesis/no rescue). This pre-specified analysis evaluates the efficacy of NEPA versus APR/GRAN in the subset of Chinese patients in the study. In addition, efficacy in patients at greatest emetic risk receiving high-dose cisplatin (≥70 mg/m 2  ) was explored. Chemotherapy-naïve patients with solid tumors in this randomized, double-blind study received either a single dose of NEPA prior to cisplatin-based chemotherapy or a 3-day regimen of APR/GRAN, both with dexamethasone on Days 1-4. Efficacy was evaluated through complete response, no emesis, and no significant nausea rates during the acute (0-24 hours), delayed (25-120 hours) and overall phases as well as individual days post-chemotherapy, as the daily course of CINV protection is often unstudied. The Chinese subset included 667 patients; of these, 363 (54%) received high-dose cisplatin. Baseline characteristics were comparable. While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin. As a fixed oral NK 1  RA/5HT 3  RA combination given once/cycle, NEPA is a convenient highly effective prophylactic antiemetic that may offer better protection from CINV than a 3-day APR/GRAN regimen on Days 3-5 following highly emetogenic chemotherapy.",2020,"While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin.","['The Chinese subset included 667 patients; of these, 363 (54%) received', 'naïve patients with solid tumors', 'Chinese patients in the study', 'Chinese patients receiving highly']","['NEPA prior to cisplatin-based chemotherapy', 'granisetron (APR/GRAN', 'Chemotherapy', 'high-dose cisplatin', 'dexamethasone', 'NEPA', 'cisplatin', 'NEPA versus APR/GRAN', 'emetogenic chemotherapy (HEC']","['breakthrough CINV', 'nausea and vomiting (CINV', 'response rates', 'Efficacy', 'complete response, no emesis', 'nausea rates']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus'}]","[{'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",5.0,0.202667,"While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin.","[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Affiliated Tumour Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Lanzarotti', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Chessari', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3123']
2937,32472768,Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial.,"OBJECTIVE(S)


We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV.
DESIGN


A community cluster randomized trial.
METHODS


The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA <500 copies/ml) among all pregnant/postpartum HIV-infected women at study close (year 3). We also compared year-3 population-level viral suppression and predictors of viral suppression among all 15 to 45-year-old women by arm.
RESULTS


At baseline, 92 and 93% of 15 to 45-year-old women tested for HIV: HIV prevalence was 12.6 and 12.3%, in intervention and control communities, respectively. Among HIV-infected women self-reporting pregnancy/live birth, prevalence of viral suppression was 42 and 44% at baseline, and 81 and 76% (P = 0.02) at year 3, respectively. Among all 15 to 45-year-old HIV-infected women, year-3 population-level viral suppression was higher in intervention (77%) versus control (68%; P < 0.001). Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43). Younger age was a risk factor for nonsuppression in both arms.
CONCLUSION


The SEARCH intervention resulted in higher population viral suppression among pregnant/postpartum women than a control of baseline universal testing with ART eligibility for pregnant/postpartum women.",2020,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"['all pregnant/postpartum women, in 32 communities in Kenya and Uganda', 'pregnant and postpartum women in a universal test and treat trial', '15 to 45-year-old women by arm', 'women living with HIV']","[""universal 'test and treat' (UTT""]","['year-3 viral suppression', 'HIV: HIV prevalence', 'viral suppression', 'year-3 population-level viral suppression', 'Pregnancy/live birth', 'population viral suppression']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.305022,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Hachem', 'Initials': 'H', 'LastName': 'Saddiki', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Koss', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Musoke', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'University of California, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002564']
2938,32472776,Intraocular Lens Power Calculation Without Corneal Parameters: A New Option.,"OBJECTIVES


To compare different methods in calculating the corneal radius (R) to be used in case of intraocular lens power calculations when it is immeasurable.
METHODS


The right eyes of 1,960 patients were randomly divided into 2 equal groups. The first group of right eyes (group A) was divided in three groups according to the axial length (AL) (≤21.99 mm, between 22 and 24.99 mm, and ≥25 mm). In these groups, the correlation between the AL and the corneal radius (R) provided three different regression formulas. The second group of right eyes (group B) was used to test the following methods of estimating the R: the regression formulas determined from group A, formula from Logan et al., formula from Stenström, the mean R calculated from group A, and the fellow eye group B. A Student paired T test was used for the statistical evaluation.
RESULTS


In case of AL≤21.99, the best results have been obtained with the fellow eye R, followed by either the regression formula or the mean R from group A (mean=0.00±0.09 mm, P=0.94, mean=0.05±0.21 mm, P=0.05, mean=0.05±0.22 mm, P=0.08, respectively). In case of AL between 22 and 24.99 mm, the best results have been obtained with the fellow eye R, followed by either the regression formula or the mean R from group A (mean=-0.01±0.09 mm, P=0.38, mean=0.01±0.21 mm, P=0.12, mean=0.01±0.24 mm, P=0.18, respectively). In case of AL≥25 mm, the best results have been obtained with the fellow eye R, followed by either the regression formula or the mean R from group A (mean=-0.003±0.08 mm, P=0.94 mean=-0.004±0.25 mm, P=0.85, mean=-0.004±0.25 mm, P=0.85, respectively).
CONCLUSIONS


The new calculated regression formulas seem to represent a reliable method to calculate the R when it is undetectable, as in case of corneal dystrophies.",2020,"In case of AL≤21.99, the best results have been obtained with the fellow eye R, followed by either the regression formula or the mean R from group A (mean=0.00±0.09 mm, P=0.94, mean=0.05±0.21 mm, P=0.05, mean=0.05±0.22 mm, P=0.08, respectively).","['The right eyes of 1,960 patients']",['Intraocular Lens Power Calculation Without Corneal Parameters'],[],"[{'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0429521', 'cui_str': 'Intraocular lens power'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",[],1960.0,0.0173229,"In case of AL≤21.99, the best results have been obtained with the fellow eye R, followed by either the regression formula or the mean R from group A (mean=0.00±0.09 mm, P=0.94, mean=0.05±0.21 mm, P=0.05, mean=0.05±0.22 mm, P=0.08, respectively).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rosa', 'Affiliation': 'Department of Medicine and Surgery (N.R., M.D.B., A.C.), University of Salerno, Salerno, Italy; Ophthalmology Unit, San Giuseppe Moscati Hospital (Lucio Zeppa, Lucia Zeppa), Avellino, Italy; and Department of Ophthalmology (M.B.), Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Zeppa', 'Affiliation': ''}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'De Bernardo', 'Affiliation': ''}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Coppola', 'Affiliation': ''}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Zeppa', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Borrelli', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000719']
2939,32472928,Effect of an Innovative Mattress and Cryotherapy on Sleep after an Elite Rugby Match.,"INTRODUCTION


This study aimed to explore the relationship between elite rugby union match and post-match sleep architecture and to investigate the effects of a high-heat capacity mattress (MAT) and a whole-body cryotherapy session (WBC) on post-match sleep architecture.
METHODS


Nineteen elite male U23 rugby union players performed in three official matches, followed by three experimental conditions, in a randomized order: MAT, WBC, and no intervention (CONT). Match load was evaluated using global positioning system (GPS) trackers and video analyses. Sleep architecture was assessed by polysomnography (PSG). Core body temperature (CBT) and mattress surface temperature were monitored during sleep. Linear mixed-effects models were conducted to assess the effects of each experimental condition on sleep, with match load variables as covariates.
RESULTS


A lower wake after sleep onset (β = -10.5 min, p < 0.01) and higher rapid-eye-movement sleep proportion (β = +2.8%, p < 0.05) were reported for MAT compared with CONT. Moreover, a lower mean CBT (β = -0.135°C, p < 0.001) and mean mattress surface temperature (β = -2.736°C, p < 0.001) during sleep were observed for MAT compared CONT. Whole-body cryotherapy did not affect nocturnal CBT nor interfere with sleep architecture. For every 100-m increase in high-speed running distance, a higher slow-wave sleep (SWS; β = +1.1%, p = 0.05) and lower light sleep proportion (β = -1.2%, p < 0.05) proportion were observed. Conversely, for every 10 supplementary collisions, a lower SWS (β = -1.9, p = 0.09) and higher light sleep (β = +2.9%, p < 0.001) proportion were observed.
CONCLUSION


MAT use had a positive effect on sleep architecture after an elite rugby union match, potentially through a more efficient nocturnal heat transfer.",2020,"A lower wake after sleep onset (β = -10.5 min, p < 0.01) and higher rapid-eye-movement sleep proportion (β = +2.8%, p < 0.05) were reported for MAT compared with CONT.","['Nineteen elite male U23 rugby union players', 'Sleep after an Elite Rugby Match']","['Innovative Mattress and Cryotherapy', 'high-heat capacity mattress (MAT) and a whole-body cryotherapy session (WBC', 'MAT, WBC, and no intervention (CONT']","['sleep architecture', 'mean mattress surface temperature', 'Core body temperature (CBT) and mattress surface temperature', 'Sleep architecture', 'nocturnal CBT nor interfere with sleep architecture', 'higher light sleep', 'high-speed running distance', 'lower light sleep proportion', 'higher rapid-eye-movement sleep proportion']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0245845', 'cui_str': 'U23'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0278182', 'cui_str': 'Light sleep'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}]",19.0,0.0169283,"A lower wake after sleep onset (β = -10.5 min, p < 0.01) and higher rapid-eye-movement sleep proportion (β = +2.8%, p < 0.05) were reported for MAT compared with CONT.","[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Aloulou', 'Affiliation': 'French National Institute of Sport (INSEP), Laboratory of Sport, Expertise and Performance (EA 7370), Paris, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Luduc', 'Affiliation': 'Carnegie Applied Rugby Research (CARR) center, Institute for Sport, Physical Activity and Leisure, Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Duforez', 'Affiliation': 'Sleep and Vigilance center, Hospital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Piscione', 'Affiliation': 'Research Department, French Rugby Federation (FFR), Marcoussis, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cheradame', 'Affiliation': 'Research Department, French Rugby Federation (FFR), Marcoussis, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bieuzen', 'Affiliation': 'Institut National du Sport (INS) du Québec, Montréal, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'French National Institute of Sport (INSEP), Laboratory of Sport, Expertise and Performance (EA 7370), Paris, France.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Chennaoui', 'Affiliation': 'University Paris Descartes, VIgilance FAtigue SOMmeil unit (VIFASOM) EA 7330, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Van Beers', 'Affiliation': 'University Paris Descartes, VIgilance FAtigue SOMmeil unit (VIFASOM) EA 7330, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Nedelec', 'Affiliation': 'French National Institute of Sport (INSEP), Laboratory of Sport, Expertise and Performance (EA 7370), Paris, France.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002403']
2940,32472958,"Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial .","Rebound pain after brachial plexus block resolution and development of long-lasting pain are problems associated with volar plate fixation for distal radius fractures. The aim of this double-blind study was to evaluate the effect of a single prophylactic intravenous dose of dexamethasone in this setting. The primary endpoint was highest pain score during the first 24 hours after surgery. We included 51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius. All received premedication with oral paracetamol and etoricoxib, and a pre-operative brachial plexus block with ropivacaine. Patients were randomly allocated into two groups: a dexamethasone group receiving 16 mg dexamethasone intravenously at start of surgery and a control group receiving 4 ml saline. After surgery, all patients received fixed doses of paracetamol, etoricoxib and oxycodone, with further oxycodone added as needed in the first 48 hours. Pain, analgesic consumption and daily function were registered at predefined times up to 1 year after surgery. Median (IQR [range]) worst pain score in the first 24 hours, as assessed by verbal numeric rating scale (0-10), was 4 (2-6 [0-7]) in the dexamethasone group compared with 8 (5-8 [2-10]) in the placebo group (p < 0.001). Average pain score, 2 (1-4 [0-5]) vs. 5 (3-6 [0-8]), p = 0.001 and rescue oxycodone consumption, 5 (0-10 [0-35]) mg vs. 10 (5-15 [0-50]) mg, p = 0.037), respectively, were both significantly lower in the dexamethasone group compared with control from 8 to 24 hours. Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6]) hours, p < 0.001. Two patients (9%) in the dexamethasone group compared with 12 (50%) in the placebo group experienced worst pain scores of 8-10 during the first 36 hours (p = 0.002). At 3 and 7 days postoperatively, there were no significant differences between groups for pain scores or opioid consumption. At 6 months, 27 patients (57%) reported pain at the site of surgery, with significantly higher average pain score (p = 0.024) and worst pain score (p = 0.018) in the placebo group. At 1 year, two patients in the dexamethasone group reported pain compared with 10 in the control group (p = 0.015). We conclude that intravenous dexamethasone improves early postoperative analgesia and may also improve clinical outcomes after 6 and 12 months.",2020,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","['distal radius fracture with brachial plexus block anaesthesia', '51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius']","['volar plate fixation', 'dexamethasone group receiving 16\xa0mg dexamethasone', 'dexamethasone', 'volar plate surgery', 'ropivacaine', 'control group receiving 4\xa0ml saline', 'intravenous dexamethasone', 'paracetamol, etoricoxib and oxycodone, with further oxycodone', 'oral paracetamol and etoricoxib', 'placebo']","['Pain, analgesic consumption and daily function', 'Analgesic effect', 'early postoperative analgesia', 'verbal numeric rating scale', 'clinical outcomes', 'worst pain scores', 'highest pain score', 'average pain score', 'Brachial plexus block duration', 'Rebound pain', 'Median (IQR [range]) worst pain score', 'pain scores or opioid consumption', 'pain', 'worst pain score', 'Average pain score']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",51.0,0.547037,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holmberg', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Hassellund', 'Affiliation': 'Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Draegni', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nordby', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Ottesen', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gulestøl', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raeder', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}]",Anaesthesia,['10.1111/anae.15111']
2941,32469621,Efficacy of Adalimumab in Non-Infectious Uveitis Across Different Etiologies: A Post Hoc Analysis of the VISUAL I and VISUAL II Trials.,"PURPOSE


To assess efficacy of adalimumab versus placebo in patients with active or inactive noninfectious intermediate, posterior, or panuveitis across different etiologies.
METHODS


VISUAL I (V-I) and VISUAL II (V-II) clinical trials included adults with active or inactive uveitis, respectively, randomized to receive adalimumab or placebo. In a post hoc subgroup analysis, time to treatment failure (TTF) starting at week 6 (V-I) or week 2 (V-II) was analyzed using the Kaplan-Meier method. Hazard ratios (HR) for TTF with 95% CI were calculated with Cox proportional hazards regression.
RESULTS


The analysis included 217 V-I patients and 226 V-II patients. Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84];  P  = .006) and V-II (HR = 0.43 [CI, 0.22-0.83];  P  = .010).
CONCLUSIONS


Treatment failure risk was lower in patients with idiopathic noninfectious uveitis receiving adalimumab versus those receiving placebo.",2020,"Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84];  P  = .006) and V-II (HR = 0.43","['217\xa0V-I patients and 226\xa0V-II patients', 'patients with idiopathic noninfectious uveitis receiving', 'Non-Infectious Uveitis', 'adults with active or inactive uveitis', 'patients with active or inactive noninfectious intermediate, posterior, or panuveitis across different etiologies']","['adalimumab', 'Adalimumab', 'adalimumab or placebo', 'placebo']",['Hazard ratios (HR'],"[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.362878,"Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84];  P  = .006) and V-II (HR = 0.43","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Department of Ophthalmology, Rush University Medical Center , Chicago, IL, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Vitale', 'Affiliation': 'John A. Moan Eye Center, University of Utah , Salt Lake City, UT, USA.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Zierhut', 'Affiliation': 'University of Tübingen , Tübingen, Germany.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Department of Ophthalmology, Tokyo Medical University , Tokyo, Japan.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kron', 'Affiliation': 'AbbVie Deutschland GmbH & Co KG , Ludwigshafen, Germany.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc ., North Chicago, IL, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Pathai', 'Affiliation': 'AbbVie Ltd , Maidenhead, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fortin', 'Affiliation': 'University of Montreal , Montreal, QC, Canada.'}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1757123']
2942,32469625,A case series of suprascapular nerve block (with an historical comparator) for shoulder pain in motor neurone disease.,"BACKGROUND


Shoulder pain is a distressing but under-reported and poorly managed symptom in people with motor neurone disease.
OBJECTIVES


This study aimed to assess the efficacy of suprascapular nerve block for the management of shoulder pain in patients with motor neurone disease.
METHODS


A total of 27 patients with motor neurone disease and shoulder pain were offered a suprascapular nerve block. Ten of these patients had bilateral shoulder pain and both were injected, making a total of 37 shoulders. The patients were followed up for a total of 3 months, or until death. Shoulder pain was measured using the pain scale (out of 100) of the shoulder pain and disability index and compared with baseline scores and a placebo control group from an earlier study using the same methodology (ACTRN12619000353190).
RESULTS


Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
CONCLUSION


Suprascapular nerve block is a safe, effective therapy for patients with chronic shoulder pain.",2020,"Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
","['shoulder pain in motor neurone disease', 'patients with motor neurone disease', 'patients with chronic shoulder pain', 'people with motor neurone disease', '27 patients with motor neurone disease and shoulder pain']","['Suprascapular nerve block', 'suprascapular nerve block (with an historical comparator', 'suprascapular nerve block']","['pain scores', 'shoulder pain and disability index', 'Shoulder pain', 'bilateral shoulder pain', 'pain scale']","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",27.0,0.133856,"Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
","[{'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Shanahan', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Glaezter', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gill', 'Affiliation': 'Discipline of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Discipline of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Graf', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allcroft', 'Affiliation': 'Southern Adelaide Local Health Network, Adelaide, SA, Australia.'}]",Palliative medicine,['10.1177/0269216320929553']
2943,32470244,Prospective randomized clinical trial of primary molar crowns: 36-month results.,"PURPOSE


To clinically evaluate the clinical success of a primary zirconia molar crown, compared with stainless steel crowns (SSCs).
METHODS


This randomized, controlled clinical trial was designed as a split-mouth study. 50 subjects ranging in age from 3-7 years were recruited to provide a total of 50 paired teeth requiring primary molar crowns, each participant receiving a SSC and zirconia crown. Restorations were evaluated at 6-, 12-, 24-, and 36-month recall appointments examining the following criteria: gingival health, estimate of the degree crown was high in occlusion, surface roughness, staining on crown surface, wear of opposing arch tooth, color match, anatomic form, marginal integrity, marginal discoloration, proximal contact area, secondary caries at crown margin and parent/guardian satisfaction with crown appearance.
RESULTS


The 36-month follow up included 23 subjects (46%). 35 crowns (35%) were evaluated; of the 18 zirconia crowns and 17 SSCs, there were no failures at the 36-month evaluation. The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01). The 36-month results indicated that zirconia primary molar crowns performed similarly to an established SSC for restoration of primary molars.
CLINICAL SIGNIFICANCE


The findings from this study indicated that at 36 months, NuSmile ZR zirconia crowns clinically performed as well as stainless steel crowns.",2020,"The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01).","['primary molar crowns', '50 subjects ranging in age from 3-7 years were recruited to provide a total of 50 paired teeth requiring primary molar crowns, each participant receiving a SSC and zirconia crown']",['stainless steel crowns (SSCs'],"['gingival health', 'occlusion, surface roughness, staining on crown surface, wear of opposing arch tooth, color match, anatomic form, marginal integrity, marginal discoloration, proximal contact area, secondary caries at crown margin and parent/guardian satisfaction with crown appearance', 'zirconia crown preference']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",50.0,0.0488815,"The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01).","[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Donly', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA, donly@uthscsa.edu.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Méndez', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Claudia I', 'Initials': 'CI', 'LastName': 'Contreras', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jungyi A', 'Initials': 'JA', 'LastName': 'Liu', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",American journal of dentistry,[]
2944,32470312,Neuromuscular electrical stimulation and protein during bed rest increased CD11b+ skeletal muscle macrophages but does not correspond to muscle size or insulin sensitivity.,"With this cohort we previously demonstrated preservation of thigh lean tissue with neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) treatment during bed rest in healthy older adults. Since macrophage polarization plays a significant role in the repair and maintenance of muscle size and insulin sensitivity, we hypothesized that muscle macrophages would be induced by NMES+PRO and would correspond to an increase in lean mass and an attenuated insulin resistance response altered by bed rest. Older adults (60-80y; BMI <30 kg/m2) underwent 5-days of bed rest and were randomized to either thrice daily treatment of NMES+PRO(n=8) or CON (n=8). Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation and connective tissue were determined PRE and POST bed rest. Glucose intolerance and insulin resistance occurred after bed rest but there was not a treatment effect (p>0.10). Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON. Minor changes in non-contractile tissue were observed. However, changes in muscle macrophages or extra-cellular matrix were not related to the preservation of thigh lean mass or insulin resistance. Daily NMES+PRO treatment during bed rest induced a muscle pro-inflammatory-like macrophage response and was unrelated to muscle size or metabolic function. Study listed as clinical trial NCT02566590. Novelty Bullets • Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) increased pro-inflammatory-like macrophages and ECM content in older adults after bed rest. • NMES+PRO changes in macrophages and non-contractile tissue macrophages did not correspond with muscle size preservation or insulin sensitivity.",2020,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","['Older adults (60-80y; BMI <30 kg/m2) underwent 5-days of bed rest', 'healthy older adults', 'older adults after bed rest']","['NMES+PRO', 'NMES+PRO(n=8) or CON', 'Daily NMES+PRO', 'neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO', 'Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO']","['insulin resistance response', 'Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation and connective tissue', 'Glucose intolerance and insulin resistance', 'Pro-inflammatory-like macrophages (CD11b+,CD206', 'Novelty Bullets •']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}]",,0.065583,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","[{'ForeName': 'Paul Timothy', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'University of Utah, Physical Therapy, Salt Lake City, United States ; reidypt@miamioh.edu.'}, {'ForeName': 'Logan Thomas', 'Initials': 'LT', 'LastName': 'Edvalson', 'Affiliation': 'University of Utah, Physical Therapy, Salt Lake City, United States ; ledvalson.academia@gmail.com.'}, {'ForeName': 'Alec Iain', 'Initials': 'AI', 'LastName': 'McKenzie', 'Affiliation': 'University of Utah, Physical Therapy, Salt Lake City, United States ; alec.mckenzie@utah.edu.'}, {'ForeName': 'Jonathan Joseph', 'Initials': 'JJ', 'LastName': 'Petrocelli', 'Affiliation': 'University of Utah, Physical Therapy, Salt Lake City, United States ; jonathan.petrocelli@utah.edu.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Mahmassani', 'Affiliation': 'University of Utah, Physical Therapy, Salt Lake City, United States ; Ziad.Mahmassani@health.utah.edu.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Drummond', 'Affiliation': 'University of Utah, Physical Therapy , 520 Wakara Way , Salt Lake City, United States , 84108 ; micah.drummond@hsc.utah.edu.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0064']
2945,32470370,Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial.,"INTRODUCTION


The aim of this prospective, randomized, double-blind, clinical trial was to evaluate the effect of a preoperative, single, oral dose of diclofenac potassium (DFK) on postoperative pain and rescue-analgesic intake in patients with symptomatic irreversible pulpitis (SIP) in mandibular molars treated in one visit.
METHODS


Seventy emergency patients with moderate-to-severe preoperative pain randomly received either 50mg DFK or placebo tablets (PLC) one hour before starting endodontic treatment (n=35). Patients recorded their pain level 6, 12, 24 and 48h after treatment on a 170-mm Heft-Parker visual analogue scale. The incidence of rescue-analgesic intake was, also, recorded. Outcome data were statistically analyzed using Mann Whitney U, Friedman's test, Wilcoxon's sign rank and Chi 2  (χ 2 ) tests. Binary logistic regression assessed predisposing factors' association with postoperative pain. The significance level (α) was set at 0.05.
RESULTS


Of the 70 patients, 68 were analyzed (n=34). Both groups had similar baseline characteristics (p>0.05). DFK showed significantly less pain incidence and intensity than PLC at 48h only (p<0.05). A significant decrease occurred from 24h to 48h with DFK (p<0.05) which was not recorded with PLC (p>0.05). No difference in the incidence of rescue-analgesic intake was reported between groups (p>0.05). Food-intake timing, gender, and rescue-analgesic intake were associated with postoperative pain (p<0.05).
CONCLUSION


Premedication by a single, oral dose of 50 mg diclofenac potassium could be effective in reducing postendodontic pain at 48h after one-visit endodontic treatment in mandibular molars with SIP.",2020,"Food-intake timing, gender, and rescue-analgesic intake were associated with postoperative pain (p<0.05).
","['70 patients', 'Mandibular Molars with Symptomatic Irreversible Pulpitis', 'patients with symptomatic irreversible pulpitis (SIP) in mandibular molars treated in one visit', 'Seventy emergency patients with moderate-to-severe preoperative pain randomly received either']","['Placebo', '50mg DFK or placebo tablets (PLC', 'diclofenac potassium', 'DFK', 'diclofenac potassium (DFK', 'Diclofenac Potassium Premedication']","['Postendodontic Pain', 'pain level', 'postoperative pain and rescue-analgesic intake', 'pain incidence and intensity', 'postendodontic pain', 'incidence of rescue-analgesic intake', '170-mm Heft-Parker visual analogue scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0282131', 'cui_str': 'Diclofenac potassium'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",70.0,0.553297,"Food-intake timing, gender, and rescue-analgesic intake were associated with postoperative pain (p<0.05).
","[{'ForeName': 'Amatallah Hussein', 'Initials': 'AH', 'LastName': 'Al-Rawhani', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa Ismail', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Suzan Abdul', 'Initials': 'SA', 'LastName': 'Wanees Amin', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt. Electronic address: suzan.wanis@dentistry.cu.edu.eg.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.008']
2946,32470389,Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study.,"BACKGROUND


Randomized clinical trials have failed to show benefit from increasing intensity of renal replacement therapy (RRT), but continue to be frequently utilized. In addition, intensive RRT is associated with an increase in adverse events potentially secondary to small solute losses, such as phosphate. We hypothesized that, compared to less intensive RRT, intensive RRT would lead to longer duration of mechanical ventilation.
RESEARCH QUESTION


Does more-intensive renal replacement therapy in critically ill patients with AKI increase time to extubation from mechanical ventilation when compared with less-intensive therapy?
STUDY DESIGN AND METHODS


The ATN study was a randomized multicenter trial of more-intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration at 20 ml/kg per hour) RRT in critically ill patients with AKI. Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation were included in this cox-proportional hazards analysis. The primary outcome was the time to first successful extubation off mechanical ventilation.
RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT. Patients randomized to more-intensive RRT had on average 2.07 ventilator-free days, compared to 3.08 days in those randomized to less-intensive RRT (P<0.001) over 14 days from start of the study.
INTERPRETATION


Critically ill mechanically ventilated patients randomized to more intensive RRT have longer duration of mechanical ventilation compared to those randomized to less intensive RRT. The reasons for this, such as excessive phosphate loss from more intensive RRT, deserve further study to optimize the safety and effectiveness of CRRT delivery.",2020,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","['Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation', 'critically ill patients', 'critically ill patients with AKI']","['renal replacement therapy (RRT', 'intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration', 'intensive RRT', 'RRT', 'Renal Replacement Therapy and Duration of Mechanical Ventilation']","['time to first successful extubation off mechanical ventilation', 'hazard rate of successful extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0472688', 'cui_str': 'Continuous venovenous hemodiafiltration'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1124.0,0.192189,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","[{'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: ssharma@bwh.harvard.edu.""}, {'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.05.542']
2947,32470421,"Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.","BACKGROUND


Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
METHODS


This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
FINDINGS


Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
INTERPRETATION


This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
FUNDING


Boston Scientific.",2020,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","['313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned', '23 implanting centres in the USA', ""patients with Parkinson's disease"", ""motor symptoms of Parkinson's disease"", '160 patients included in the interim analysis, 121 (76', 'Between May 17, 2013, and Nov 30, 2017', '313 patients were enrolled across 23 sites', ""Parkinson's disease (INTREPID"", ""Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent""]","['subthalamic nucleus DBS with a novel MICC device', 'Subthalamic nucleus deep brain stimulation', 'Deep brain stimulation (DBS', 'active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group', 'novel multiple independent contact current-controlled (MICC) device']","['ON time without troublesome dyskinesias', 'anti-parkinsonian medications', 'mean number of waking hours per day with good symptom control and no troublesome dyskinesias', '26 serious adverse events', 'mean change from baseline visit to 3 months post-randomisation']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",313.0,0.575314,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","[{'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Vitek', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Tröster', 'Affiliation': 'Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schrock', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'House', 'Affiliation': 'Neurosurgical Associates, Murray, UT, USA.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'Giroux', 'Affiliation': 'Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Hebb', 'Affiliation': 'Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sierra M', 'Initials': 'SM', 'LastName': 'Farris', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Whiting', 'Affiliation': 'Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Leichliter', 'Affiliation': 'Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Ostrem', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Luciano', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Tatter', 'Affiliation': 'Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ihtsham', 'Initials': 'I', 'LastName': 'Ul Haq', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gostkowski', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tagliati', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Adam N', 'Initials': 'AN', 'LastName': 'Mamelak', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Moguel-Cobos', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Ponce', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jules M', 'Initials': 'JM', 'LastName': 'Nazzaro', 'Affiliation': 'Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cathrin M', 'Initials': 'CM', 'LastName': 'Buetefisch', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gross', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Corneliu C', 'Initials': 'CC', 'LastName': 'Luca', 'Affiliation': 'Department of Neurology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Jagid', 'Affiliation': 'Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Revuelta', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Takacs', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pourfar', 'Affiliation': 'Department of Neurology, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Alon Y', 'Initials': 'AY', 'LastName': 'Mogilner', 'Affiliation': 'Department of Neurosurgery, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Mandybur', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Cooper', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Suketu M', 'Initials': 'SM', 'LastName': 'Khandhar', 'Affiliation': 'Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sedrak', 'Affiliation': 'Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Pilitsis', 'Affiliation': 'Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Uitti', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Starr', 'Affiliation': 'Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30108-3']
2948,32470438,"Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.","BACKGROUND


Transfusion-dependent haemoglobinopathies require lifelong iron chelation therapy with one of the three iron chelators (deferiprone, deferasirox, or deferoxamine). Deferasirox and deferiprone are the only two oral chelators used in adult patients with transfusion-dependent haemoglobinopathies. To our knowledge, there are no randomised clinical trials comparing deferiprone, a less expensive iron chelator, with deferasirox in paediatric patients. We aimed to show the non-inferiority of deferiprone versus deferasirox.
METHODS


DEEP-2 was a phase 3, multicentre, randomised trial in paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies. The study was done in 21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK. Participants were receiving at least 150 mL/kg per year of red blood cells for the past 2 years at the time of enrolment, and were receiving deferoxamine (<100 mg/kg per day) or deferasirox (<40 mg/kg per day; deferasirox is not registered for use in children aged <2 years so only deferoxamine was being used in these patients). Any previous chelation treatment was permitted with a 7-day washout period. Patients were randomly assigned 1:1 to receive orally administered daily deferiprone (75-100 mg/kg per day) or daily deferasirox (20-40 mg/kg per day) administered as dispersible tablets, both with dose adjustment for 12 months, stratified by age (<10 years and ≥10 years) and balanced by country. The primary efficacy endpoint was based on predefined success criteria for changes in serum ferritin concentration (all patients) and cardiac MRI T2-star (T2*; patients aged >10 years) to show non-inferiority of deferiprone versus deferasirox in the per-protocol population, defined as all randomly assigned patients who received the study drugs and had available data for both variables at baseline and after 1 year of treatment, without major protocol violations. Non-inferiority was based on the two-sided 95% CI of the difference in the proportion of patients with treatment success between the two groups and was shown if the lower limit of the two-sided 95% CI was greater than -12·5%. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with EudraCT, 2012-000353-31, and ClinicalTrials.gov, NCT01825512.
FINDINGS


435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group). 352 (90%) of 390 patients had β-thalassaemia major, 27 (7%) had sickle cell disease, five (1%) had thalassodrepanocytosis, and six (2%) had other haemoglobinopathies. Median follow-up was 379 days (IQR 294-392) for deferiprone and 381 days (350-392) for deferasirox. Non-inferiority of deferiprone versus deferasirox was established (treatment success in 69 [55·2%] of 125 patients assigned deferiprone with primary composite efficacy endpoint data available at baseline and 1 year vs 80 [54·8%] of 146 assigned deferasirox, difference 0·4%; 95% CI -11·9 to 12·6). No significant difference between the groups was shown in the occurrence of serious and drug-related adverse events. Three (2%) cases of reversible agranulocytosis occurred in the 193 patients in the safety analysis in the deferiprone group and two (1%) cases of reversible renal and urinary disorders (one case of each) occurred in the 197 patients in the deferasirox group. Compliance was similar between treatment groups: 183 (95%) of 193 patients in the deferiprone group versus 192 (97%) of 197 patients in the deferisirox group.
INTERPRETATION


In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment. Considering the need for availability of more chelation treatments in paediatric populations, deferiprone offers a valuable treatment option for this age group.
FUNDING


EU Seventh Framework Programme.",2020,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","['paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2', 'paediatric patients with transfusion-dependent', '21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK', 'paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies', 'group versus 192 (97%) of 197 patients in the deferisirox group', '435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group', 'adult patients with transfusion-dependent haemoglobinopathies', 'paediatric patients']","['daily deferasirox', 'daily deferiprone', 'deferoxamine', 'haemoglobinopathies, deferiprone', 'Deferasirox and deferiprone', 'deferiprone', 'deferasirox', 'deferiprone versus deferasirox']","['Safety', 'Compliance', 'serum ferritin concentration', 'efficacy and safety', 'occurrence of serious and drug-related adverse events', 'sickle cell disease', 'reversible agranulocytosis', 'reversible renal and urinary disorders']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001824', 'cui_str': 'Agranulocytosis'}, {'cui': 'C0042075', 'cui_str': 'Disorder of urinary tract'}]",435.0,0.255378,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Maggio', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. Electronic address: aurelio.maggio@villasofia.it.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'First Department of Pediatrics, National and Kapodistriam University of Athens, Athens, Greece.'}, {'ForeName': 'Mariagrazia', 'Initials': 'M', 'LastName': 'Felisi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reggiardo', 'Affiliation': 'Biostatistics and Data Management Unit, Medi Service, Genoa, Italy.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Pediatric Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bejaoui', 'Affiliation': 'Pediatrics and Bone Marrow Transplantation Centre, Tunis, Tunisia.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Sherief', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Soteroula', 'Initials': 'S', 'LastName': 'Christou', 'Affiliation': 'Thalassaemia Center, Hospital Archbishop Makarios III, Nicosia, Cyprus.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cosmi', 'Affiliation': 'Clinica Pediatrica, Azienda Ospedaliero Universitaria (AOU) Sassari, Sassari, Italy.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics Group, University College London, London, UK.'}, {'ForeName': 'Giovanni Carlo', 'Initials': 'GC', 'LastName': 'Del Vecchio', 'Affiliation': 'UO Pediatrica B Trambusti, AOU Consorziale Policlinico-Giovanni XXIII, Bari, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Filosa', 'Affiliation': 'UOSD Malattie rare del globulo rosso, AORN A Cardarelli, Napoli, Italy.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Cuccia', 'Affiliation': 'UOC Ematologia con Talassemia, Dipartimento di Medicina, AO Civico Di Cristina-Benfratelli, Palermo, Italy.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Hassab', 'Affiliation': 'Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Kreka', 'Affiliation': 'Pediatrics Department, University Hospital Center Mother Teresa, Tirana, Albania.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'DH Talassemia, Ospedale Pediatrico Microcitemico A CAO, AO G Brotzu, Cagliari, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Putti', 'Affiliation': ""Department of Women's and Child's Health (DSDB), University Hospital, Padova, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Telfer', 'Affiliation': 'Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Tempesta', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vitrano', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Yu Chung', 'Initials': 'YC', 'LastName': 'Tsang', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Zaka', 'Affiliation': 'Center of Thalassemia, Hospital Ihsan Cabej, Lushnje, Albania.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Bonifazi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ceci', 'Affiliation': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Valenzano, Italy.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30100-9']
2949,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND


Accumulating evidence proposed JAK inhibitors as therapeutic targets warranting rapid investigation.
OBJECTIVE


This study evaluated the efficacy and safety of ruxolitinib, a Janus-associated kinase (JAK1/2) inhibitor, for COVID-19.
METHODS


We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe COVID-19.
RESULTS


Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus SoC treatment (22 patients) or placebo based on SoC treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in intervention group and 21 patients in control group were included in the study. Treatment with ruxolitinib plus SoC was not associated with significantly accelerated clinical improvement in severe patients with COVID-19, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed CT improvement at D 14  compared with 13 (61.9%) patients from the control group (P = 0.0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at D 28 ; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group.
CONCLUSIONS


Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population. This trial is registered at www.chictr.org.cn as ChiCTR-OPN-2000029580.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, No. 215 Zhongshan Ave., Wuhan, 430022, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, 410013, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Cite of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, No. 1095 Jie Fang Avenue, 430030, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, 410013, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, No. 215 Zhongshan Ave., Wuhan, 430022, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Cite of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, No. 1095 Jie Fang Avenue, 430030, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Room S7.224, Cincinnati, Ohio, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China;. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019']
2950,32470492,Mediators of the effects of canagliflozin on kidney protection in patients with type 2 diabetes.,"Canagliflozin reduced kidney disease progression in participants with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program that explored potential mediators of the effects of canagliflozin on kidney outcomes. The percent mediating effect of 18 biomarkers indicative of disease was determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the average post-randomization level of each biomarker. Multivariable analyses assessed the joint effects of biomarkers that mediated most strongly in univariable analyses. The kidney outcome was defined as a composite of 40% estimated glomerular filtration rate decline, end-stage kidney disease, or death due to kidney disease. Nine biomarkers (systolic blood pressure [8.9% of effect explained], urinary albumin:creatinine ratio [UACR; 23.9%], gamma glutamyltransferase [4.1%], hematocrit [51.1%], hemoglobin [41.3%], serum albumin [19.5%], erythrocytes [56.7%], serum urate [35.4%], and urine pH [7.5%]) individually mediated the effect of canagliflozin on the kidney outcome. In a parsimonious multivariable model, erythrocyte concentration, serum urate, and systolic blood pressure maximized cumulative mediation (115%). Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively. The identified mediators support existing hypothesized mechanisms for the prevention of kidney outcomes with sodium glucose co-transporter 2 inhibitors. Thus, the disparity in mediating effects across baseline UACR subgroups suggests that the mechanism for kidney protection with canagliflozin may vary across patient subgroups.",2020,"Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively.","['participants with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program', 'patients with type 2 diabetes']","['Canagliflozin', 'UACR', 'canagliflozin']","['erythrocyte concentration, serum urate, and systolic blood pressure maximized cumulative mediation', 'kidney protection', 'serum albumin', 'serum urate', 'urinary albumin:creatinine ratio [UACR; 23.9%], gamma glutamyltransferase', 'hematocrit', 'glomerular filtration rate decline, end-stage kidney disease, or death due to kidney disease', 'hemoglobin', 'kidney disease progression', 'Nine biomarkers (systolic blood pressure']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0810127,"Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively.","[{'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Department of Cardiology, Xinqiao Hospital, Army Military Medical University, Chongqing, China and Department of Cardiology, People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Simpson', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center, Groningen, The Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",Kidney international,['10.1016/j.kint.2020.04.051']
2951,32470515,Ramipril in High Risk Patients with COVID-19.,"BACKGROUND


The coronavirus disease 2019 (COVID-19) is caused by SARS-CoV2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2 (ACE-2). This interaction has been proposed as a potential risk factor in patients treated with RAAS-inhibitors.
OBJECTIVES


To analyze if RAAS-inhibitors modify the risk for COVID-19.
METHODS


RASTAVI (NCT03201185) is an ongoing randomized clinical trial randomly allocating Ramipril or control after successful transcatheter aortic valve replacement at 14 centers is Spain. We performed a non-pre-specified interim analysis to evaluate its impact on COVID-19 risk in this vulnerable population.
RESULTS


As in April 1 st  2020, 102 patients (50 Ramipril and 52 controls) were included in the trial. Mean age was 82.3±6.1 years, 56.9% males. Median time of Ramipril treatment was 6 months [IQR:2.9-11.4]. Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving Ramipril, HR=1.150 [95%CI: 0.351-3.768]). The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065). Admission and oxygen supply was required in 4.9% (2 patients in the Ramipril and 3 in control), and 4 of them died (two in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p=0.039).
CONCLUSIONS


In a high risk population of old patients with cardiovascular disease, randomization to Ramipril had no impact in the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS-inhibitor treatment during COVID-19 crisis.",2020,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","['High Risk Patients with COVID-19', 'patients treated with RAAS-inhibitors', '102 patients (50 Ramipril and 52 controls) were included in the trial', 'Mean age was 82.3±6.1 years, 56.9% males']",['Ramipril'],"['Admission and oxygen supply', 'mortality rate', 'risk of COVID-19', 'atrial fibrillation', 'incidence or severity of COVID-19', 'Median time']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.117341,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","[{'ForeName': 'Ignacio J', 'Initials': 'IJ', 'LastName': 'Amat-Santos', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain. Electronic address: ijamat@gmail.com.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Santos-Martinez', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'López-Otero', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC. Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez-Ibanes', 'Affiliation': 'CIBERCV, Hospital General Gregorio Marañón and Universidad Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Del Valle', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Muñoz-García', 'Affiliation': 'CIBERCV, Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Víctor A', 'Initials': 'VA', 'LastName': 'Jiménez-Diaz', 'Affiliation': 'Hospital Universitario de Vigo, Vigo, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': 'Hospital Clinic Univeristari, Barcelona, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'González-Ferreiro', 'Affiliation': 'Hospital Clínico Universitario, Salamanca, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Benito', 'Affiliation': 'Hospital Universitario de León, León, Spain.'}, {'ForeName': 'Xoan Carlos', 'Initials': 'XC', 'LastName': 'Sanmartin-Pena', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Catalá', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Rodríguez-Gabella', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Jose Raúl', 'Initials': 'JR', 'LastName': 'Delgado-Arana', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carrasco-Moraleja', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibañez', 'Affiliation': 'CIBERCV, Centro Nacional de Investigaciones Cardiovasculares (CNIC), IIS-Hospital Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'San Román', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario, Valladolid, Spain.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.040']
2952,32470710,Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial.,"BACKGROUND


Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79).
PATIENTS AND METHODS


In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 μg/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20).
RESULTS


Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons.
CONCLUSIONS


The EORTC 18081 PEG-IFNα-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes.",2020,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","['only 112 patients were randomised, 56 in each arm', 'stage II B/C patients with ulcerated primary', 'sentinel node-negative stage II patients with an ulcerated primary melanoma', 'patients with ulcerated melanomas without palpable nodes', 'Between February 2013 and January 2017']","['adjuvant (PEG)-IFNα-2b treatment', 'pegylated interferon-alfa2b vs observation', 'pegylated (PEG)-IFNα-2b']","['distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20', '3-year RFS rate', 'DMFS', 'toxicity', '3-year DMFS rate']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.689158,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Prinses Maxima Centrum, Utrecht, the Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. Electronic address: piotr.rutkowski@pib-nio.pl.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'CHU de Bordeaux, Groupe Hospitalier Saint-André, Hopital Saint-André, Bordeaux, France. Electronic address: caroline.dutriaux@chu-bordeaux.fr.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hofman-Wellenhof', 'Affiliation': 'Medical University of Graz, Graz, Austria. Electronic address: rainer.hofmann@medunigraz.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dziewulski', 'Affiliation': 'Mid Essex Hospitals, Broomfield Hospital, Broomfield, United Kingdom. Electronic address: peter.dziewulski@meht.nhs.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ""Leeds Teaching Hospitals NHS Trust, St. James's University Hospital, Leeds, United Kingdom. Electronic address: maria.marples@nhs.net.""}, {'ForeName': 'Floren', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'CHU de Reims, Hôpital Robert Debré, Reims, France. Electronic address: fgrange@chu-reims.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lok', 'Affiliation': 'CHU Amiens, Hopital Sud, Amiens, France. Electronic address: lok.catherine@chu-amiens.fr.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Pennachioli', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy. Electronic address: elisabetta.pennacchioli@ieo.it.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif & Paris-Saclay University, Saint-Aubin, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands. Electronic address: a.v.akkooi@nki.nl.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Odense University Hospital, Odense, Denmark. Electronic address: lars.bastholt@rsyd.dk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Minisini', 'Affiliation': 'Azienda Sanitaria Universitaria Del Friuli Centrale, Udine, Italy. Electronic address: alessandro.minisini@asufc.sanita.fvg.it.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'St Helens & Knowsley NHS Trust, Whiston Hospital, Prescot, United Kingdom. Electronic address: emarshall@nhs.net.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salès', 'Affiliation': 'Institut Jules Bordet-Hopital Universitaire ULB, Brussels, Belgium. Electronic address: fsales@bordet.be.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Assistance Publique, Hopitaux de Marseille, Hôpital de La Timone (APHM), Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bechter', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium. Electronic address: oliver.bechter@uzleuven.be.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen & German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: sandrine.marreaud@eortc.org.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: michal.kicinski@eortc.org.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: stefan.suciu@eortc.org.'}, {'ForeName': 'Alessandro A E', 'Initials': 'AAE', 'LastName': 'Testori', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: A.Testori@smatteo.pv.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.015']
2953,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
2954,32470918,Training Program With Outdoor Fitness Equipment in Parks Offers No Substantial Benefits for Functional Fitness in Active Seniors: A Randomized Controlled Trial.,"Outdoor fitness equipment (OFE) is installed in parks to promote health, particularly among seniors. However, no quantitative study has investigated its effectiveness. Therefore, this study aimed to examine the effectiveness of 12 weeks of OFE training on functional fitness in seniors. Forty-two active seniors were recruited and randomly assigned into OFE and control groups. The OFE group underwent 12 weeks of training using popular OFE for cardiorespiratory function, flexibility, and strength, whereas participants in the control group were asked to maintain their previous lifestyles. The senior fitness test was assessed before and after the 12-week period. Unexpectedly, the results showed no significant improvement within or between the groups after the 12-week training in all parameters (p > .05). In conclusion, the 12-week OFE training failed to enhance functional fitness among active seniors. Potential reasons for the limited training effects might be lack of resistance components and diversity of the OFE design and installation.",2020,"Unexpectedly, the results showed no significant improvement within or between the groups after the 12-week training in all parameters (p > .05).","['seniors', 'Forty-two active seniors', 'Active Seniors']","['OFE', 'Outdoor fitness equipment (OFE', 'OFE training']",['functional fitness'],"[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",42.0,0.0156476,"Unexpectedly, the results showed no significant improvement within or between the groups after the 12-week training in all parameters (p > .05).","[{'ForeName': 'Ya-Chen', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'I-Yao', 'Initials': 'IY', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Hope Li-Ling', 'Initials': 'HL', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Wei-Han', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0009']
2955,32470921,Incorporating Behavior Change Strategies Into an Exercise Trial to Improve Physical Activity Maintenance Among Adults at High Risk for Type II Diabetes.,"This study examined the feasibility and effects of a 1-hr physical activity (PA) behavior change (PABC) discussion session on PA, 12 weeks after completing an exercise trial. Adults at high risk of Type II diabetes were randomized to the PABC or a control group. PA was self-reported using the International Physical Activity Questionnaire. Chi-square tests compared the proportion of participants classified as moderately active or greater at the 12-week follow-up. Participants (N = 50) were M = 61.8 ± 5.5 years old and mostly female (80%). All participants completed the PABC discussion session, and compliance with the International Physical Activity Questionnaire at 12-week follow-up was 78%. Barrier self-efficacy increased immediately following the PABC (MΔ0.5 ± 0.9; t(22) = -2.45, p = .023). At 12-week follow-up, 88% in the PABC were moderately active or greater, compared with 50% in the control (p = .015). Incorporating a PABC discussion session as part of an exercise efficacy trial was feasible and may help improve PA maintenance.",2020,Barrier self-efficacy increased immediately following the PABC (MΔ0.5 ± 0.9; t(22) =,"['Adults at high risk of Type II diabetes', 'Adults at High Risk for Type II Diabetes', 'Participants (N = 50) were M = 61.8 ± 5.5\xa0years old and mostly female (80']","['PABC', 'physical activity (PA) behavior change (PABC) discussion session']","['PA maintenance', 'Physical Activity Maintenance', 'Barrier self-efficacy', 'PABC discussion session, and compliance with the International Physical Activity Questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0048090', 'cui_str': '4-azidobenzylcarazolol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0048090', 'cui_str': '4-azidobenzylcarazolol'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0265998,Barrier self-efficacy increased immediately following the PABC (MΔ0.5 ± 0.9; t(22) =,"[{'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Konopka', 'Affiliation': ''}, {'ForeName': 'Kelli A', 'Initials': 'KA', 'LastName': 'LeBreton', 'Affiliation': ''}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Karyn L', 'Initials': 'KL', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leach', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0307']
2956,32470922,Training Load and Carbohydrate Periodization Practices of Elite Male Australian Football Players: Evidence of Fueling for the Work Required.,"The authors aimed to quantify (a) the periodization of physical loading and daily carbohydrate (CHO) intake across an in-season weekly microcycle of Australian Football and (b) the quantity and source of CHO consumed during game play and training. Physical loading (via global positioning system technology) and daily CHO intake (via a combination of 24-hr recall, food diaries, and remote food photographic method) were assessed in 42 professional male players during two weekly microcycles comprising a home and away fixture. The players also reported the source and quantity of CHO consumed during all games (n = 22 games) and on the training session completed 4 days before each game (n = 22 sessions). The total distance was greater (p < .05) on game day (GD; 13 km) versus all training days. The total distance differed between training days, where GD-2 (8 km) was higher than GD-1, GD-3, and GD-4 (3.5, 0, and 7 km, respectively). The daily CHO intake was also different between training days, with reported intakes of 1.8, 1.4, 2.5, and 4.5 g/kg body mass on GD-4, GD-3, GD-2, and GD-1, respectively. The CHO intake was greater (p < .05) during games (59 ± 19 g) compared with training (1 ± 1 g), where in the former, 75% of the CHO consumed was from fluids as opposed to gels. Although the data suggest that Australian Football players practice elements of CHO periodization, the low absolute CHO intakes likely represent considerable underreporting in this population. Even when accounting for potential underreporting, the data also suggest Australian Football players underconsume CHO in relation to the physical demands of training and competition.",2020,The total distance was greater (p < .05) on game day (GD; 13 km) versus all training days.,"['42 professional male players during two weekly microcycles comprising a home and away fixture', 'Elite Male Australian Football Players']","['Physical loading (via global positioning system technology) and daily CHO intake (via a combination of 24-hr recall, food diaries, and remote food photographic method']","['total distance', 'CHO intake', 'physical loading and daily carbohydrate (CHO) intake', 'daily CHO intake']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2350032', 'cui_str': 'Global Positioning System'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",42.0,0.0382551,The total distance was greater (p < .05) on game day (GD; 13 km) versus all training days.,"[{'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Routledge', 'Affiliation': 'Liverpool John Moores University.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'Port Adelaide Football Club.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Di Michele', 'Affiliation': 'University of Bologna.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Burgess', 'Affiliation': 'Port Adelaide Football Club.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Erskine', 'Affiliation': 'Liverpool John Moores University.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Close', 'Affiliation': 'Liverpool John Moores University.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Liverpool John Moores University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2019-0311']
2957,32470981,Energy Requirement Is Higher During Weight-Loss Maintenance in Adults Consuming a Low- Compared with High-Carbohydrate Diet.,"BACKGROUND


Longer-term feeding studies suggest that a low-carbohydrate diet increases energy expenditure, consistent with the carbohydrate-insulin model of obesity. However, the validity of methodology utilized in these studies, involving doubly labeled water (DLW), has been questioned.
OBJECTIVE


The aim of this study was to determine whether dietary energy requirement for weight-loss maintenance is higher on a low- compared with high-carbohydrate diet.
METHODS


The study reports secondary outcomes from a feeding study in which the primary outcome was total energy expenditure (TEE). After attaining a mean Run-in weight loss of 10.5%, 164 adults (BMI ≥25 kg/m2; 70.1% women) were randomly assigned to Low-Carbohydrate (percentage of total energy from carbohydrate, fat, protein: 20/60/20), Moderate-Carbohydrate (40/40/20), or High-Carbohydrate (60/20/20) Test diets for 20 wk. Calorie content was adjusted to maintain individual body weight within ± 2 kg of the postweight-loss value. In analyses by intention-to-treat (ITT, completers, n = 148) and per protocol (PP, completers also achieving weight-loss maintenance, n = 110), we compared the estimated energy requirement (EER) from 10 to 20 wk of the Test diets using ANCOVA.
RESULTS


Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323 (122-525) kcal/d; P ≤0.02]. This difference remained significant in sensitivity analyses accounting for change in adiposity and possible nonadherence.
CONCLUSIONS


Energy requirement was higher on a low- versus high-carbohydrate diet during weight-loss maintenance in adults, commensurate with TEE. These data are consistent with the carbohydrate-insulin model and lend qualified support for the validity of the DLW method with diets varying in macronutrient composition. This trial was registered at clinicaltrials.gov as NCT02068885.",2020,Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323,"['164 adults (BMI\xa0≥25 kg/m2; 70.1% women', 'Adults Consuming a Low- Compared with High-Carbohydrate Diet']","['Moderate-Carbohydrate (40/40/20), or High-Carbohydrate (60/20/20) Test diets']","['weight-loss maintenance', 'total energy expenditure (TEE', 'Mean EER']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]",,0.136023,Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323,"[{'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bielak', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Lakin', 'Affiliation': ""Institutional Centers for Clinical and Translational Research; Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gloria L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Wong', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Luoto', 'Affiliation': 'Department of Food and Nutrition, Framingham State University, Framingham, MA, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Wong', 'Affiliation': ""USDA/Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine,Houston, TX, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa150']
2958,32471080,"Effectiveness of a Family Intervention to Increase Physical Activity in Disadvantaged Areas-A Healthy Generation, a Controlled Pilot Study.","There are large social inequalities in health. The purpose of this study was to evaluate the effects of a family intervention on physical activity (PA) and sedentary time (ST) in children and their parents. In this controlled pilot study, all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included. The intervention was run by a foundation in co-operation with the municipality. The 9-month program included: (1) activity sessions, (2) healthy meals, (3) health information and (4) parental support groups. PA was primary outcome and ST was secondary outcome, measured by accelerometry. In total, 40 of the children (60%) and 45 of the adults (50%) had at least one day of valid accelerometer data at both baseline and follow-up. Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends. There were no differences between groups in the other PA variables or ST. This pilot study shows that it is possible to influence PA in families from a disadvantaged area through a family program.",2020,"Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends.","['all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included', 'families from a disadvantaged area through a family program', 'Disadvantaged Areas', 'children and their parents']","['activity sessions, (2) healthy meals, (3) health information and (4) parental support groups', 'family intervention', 'Family Intervention']","['physical activity (PA) and sedentary time (ST', 'total PA']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0240404,"Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends.","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, 118 63 Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17113794']
2959,32471106,Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study.,"BACKGROUND


the aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods :  single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE ® , Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy.
RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥ 20 ng/mL and 93.1% had 25 (OH)D levels ≥ 30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥ 30 ng/mL. No serious adverse events occurred during the study.
CONCLUSIONS


normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure.",2020,"RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","['otherwise healthy vitamin D-deficient population', 'adults in Italy', 'healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL', 'Healthy Subjects with Vitamin D Deficiency']","['high-dose vitamin D supplementation', 'Oral Cholecalciferol', 'cholecalciferol (DIBASE ®', 'cholecalciferol']","['OH)D levels ≥', '25 (OH)D levels ≥', 'serious adverse events', 'normalization of 25 (OH)D serum levels', 'pharmacokinetic (PK) and safety profile', 'mean 25 (OH)D plasma levels']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.0510382,"RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Fassio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Adami', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Rossini', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Giollo', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Caimmi', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bixio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Viapiana', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Milleri', 'Affiliation': 'Centro Ricerche Cliniche di Verona SRL, 37131 Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}]",Nutrients,['10.3390/nu12061553']
2960,32471186,Vitamin E-Bonded Membranes Do Not Influence Markers of Oxidative Stress in Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion.,"BACKGROUND


Increased oxidative stress is a hallmark of end-stage renal disease. Hemodialysis (HD) patients lacking glutathione transferase M1 (GSTM1) enzyme activity exhibit enhanced oxidative DNA damage and higher mortality rate than those with active GSTM1 enzyme. To our knowledge, this is the first study to use the vitamin E-bonded membranes (VEM) in patients with homozygous  GSTM1  gene deletion, and we aimed to determine the effect of VEM on oxidative and inflammatory status in HD patients with homozygous  GSTM1  gene deletion.
METHODS


GSTM1  genotypes were determined by polymerase chain reaction (PCR) in 170 chronic HD patients. Those with  GSTM1-null  genotype were randomized and 80 were included in the study. Forty of them were dialyzed for three months with VEM, while the other forty were dialyzed with high-flux same-surface polysulfone dialyzers. Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD)) were determined.
RESULTS


Seventy-five patients finished the study. There were no differences at baseline in markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity. After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups. SOD and C reactive protein (CRP) did not change significantly during the three-month period. IL-6 increased in the control group, and at the same time, decreased in the VEM group, but without statistical significance. Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron did not change significantly within or between groups. Regarding other laboratory parameters, proteins, albumins, triglycerides, serum phosphorus, serum bicarbonate and Kt/V showed significant improvements within groups but with no significant difference between groups.
CONCLUSIONS


Our data shows that therapy with VEM over three months had no benefit over standard polysulfone membrane in decreasing by-products of oxidative stress and inflammation in dialysis patients lacking GSTM1 enzyme activity.",2020,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","['Seventy-five patients finished the study', '170 chronic HD patients', 'Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion', 'patients with homozygous  GSTM1  gene deletion', 'Those with  GSTM1-null  genotype were randomized and 80 were included in the study', 'HD patients with homozygous  GSTM1  gene deletion']","['VEM', 'Vitamin E-Bonded Membranes', 'polymerase chain reaction (PCR', 'vitamin E-bonded membranes (VEM']","['Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron', 'Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD', 'Oxidative Stress', 'SOD and C reactive protein (CRP', 'markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity', 'IL-6', 'triglycerides, serum phosphorus, serum bicarbonate and Kt/V']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}, {'cui': 'C0017260', 'cui_str': 'Gene deletion'}, {'cui': 'C1738886', 'cui_str': 'GSTM1 protein, human'}, {'cui': 'C0456148', 'cui_str': 'Null'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}]",170.0,0.0267835,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Djuric', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Suvakov', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Simic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Markovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Djurdja', 'Initials': 'D', 'LastName': 'Jerotic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Jankovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bulatovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Tosic Dragovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Damjanovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Marinkovic', 'Affiliation': 'Institute of Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Radomir', 'Initials': 'R', 'LastName': 'Naumovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Dimkovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}]",Toxins,['10.3390/toxins12060352']
2961,32471382,NORAD01-GRECCAR16 multicenter phase III non-inferiority randomized trial comparing preoperative modified FOLFIRINOX without irradiation to radiochemotherapy for resectable locally advanced rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE trial).,"BACKGROUND


Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT.
METHODS


This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574.
DISCUSSION


The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.",2020,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"['rectal cancer patients', 'Patients with mid or low resectable LARC', 'patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N']","['preoperative modified FOLFIRINOX without irradiation to radiochemotherapy', 'Preoperative radiochemotherapy (RCT', 'RCT', 'NORAD01-GRECCAR16', 'cT3N0 or cT1-T3N+ with circumferential resection margin [CRM]\u2009', 'Cap50 intensified-modulated radiotherapy', 'chemotherapy']","['3-year progression-free survival (PFS', 'treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.14794,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Brouquet', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France. antoine.brouquet@aphp.fr.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': ""Service d'Oncologie Digestive, Hôpital de la Pitié Salpétrière, Assistance Publique, Hôpitaux de Paris, Paris, 75013, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': 'Service de Radiothérapie, Hôpital Tenon, Assistance Publique, Hôpitaux de Paris, Paris, 75020, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Karoui', 'Affiliation': 'Service de Chirurgie Digestive, Hôpital Européen Georges Pompidou, Assistance Publique, Hôpitaux de Paris, Paris, 75015, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Artru', 'Affiliation': ""Centre d'oncologie Jean Mermoz, Lyon, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Service de Chirurgie Digestive, CHU Amiens, Amiens, 60000, France.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefèvre', 'Affiliation': 'Service de Chirurgie Générale et Digestive, Hôpital Saint Antoine, Assistance Publique, Hôpitaux de Paris, Paris, 75012, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Unité de recherche clinique CHU, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, CHU Lille, Lille, 59000, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique Paris VII, Assistance Publique, Hôpitaux de Paris, Paris, 75010, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Benoist', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-06968-1']
2962,32471387,Developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: a two-year interim report of a randomized single-blind multicenter controlled trial.,"BACKGROUND


Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach.
METHODS


We conducted a randomized, single-blind controlled trial to assess a novel intervention: the ""Developmental and Sequenced One-to-One Intervention (DS1-EI)"". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months.
RESULTS


At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups.
CONCLUSIONS


The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended.
TRIAL REGISTRATION


ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.",2020,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"['autism spectrum disorder and intellectual disability', 'Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study', 'children with ID and ASD and in France', '9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID', 'Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID', '72 participants were randomized']","['DS1-EI', 'http://www.anzctr.org.au', 'Developmental and sequenced one-to-one educational intervention (DS1-EI', 'Developmental and Sequenced One-to-One Intervention (DS1-EI', 'TAU']","['feasibility and efficacy', 'Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS', 'Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077959', 'cui_str': 'VAB II protocol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",72.0,0.0655832,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Tanet', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Hubert-Barthelemy', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'Marie-Noëlle', 'Initials': 'MN', 'LastName': 'Clément', 'Affiliation': 'Hôpital de jour André Boulloche, association Cerep-Phymentin, 56 rue du Faubourg Poissonnière, 75010, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Soumille', 'Affiliation': ""Association Régionale pour l'Intégration, 26 rue Saint Sébastien, 13006, Marseille, France.""}, {'ForeName': 'Graciela C', 'Initials': 'GC', 'LastName': 'Crespin', 'Affiliation': ""Association Programme de Recherche et d'Etudes sur l'Autisme, 7, square Dunois, 75013, Paris, France.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Pellerin', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'François-André', 'Initials': 'FA', 'LastName': 'Allaert', 'Affiliation': 'CEN Biotech, Parc Mazen-Sully, Zone des biotechnologies, Impasse Françoise Dolto, 21000, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France. david.cohen@aphp.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Saint-Georges', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02156-z']
2963,32471390,Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.,"BACKGROUND


It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment.
METHODS


The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ≥5 are randomized to the intervention or control group while patients scoring ≤4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2 weeks and 3, 6, 9 and 12 months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated.
DISCUSSION


This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03434717. Registered February 15, 2018.",2020,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"['Women with newly diagnosed BC', 'women suffer from negative consequences following breast cancer (BC', 'primary breast cancer treatment']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],[],,0.127976,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Olsson Möller', 'Affiliation': 'Department of Nursing and Integrated Health Sciences, Faculty of Health Sciences, Kristianstad University, Kristianstad, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Clinical Sciences Lund, Surgery, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malmström', 'Affiliation': 'Department of Health Sciences, Lund University, Box 157, 221 00, Lund, Sweden. marlene.malmstrom@med.lu.se.'}]",BMC cancer,['10.1186/s12885-020-06815-3']
2964,32471400,"Effectiveness of a family intervention on health-related quality of life-a healthy generation, a controlled pilot trial.","BACKGROUND


Physical activity is associated with better health, but knowledge about health promoting interventions, including physical activity for families in disadvantaged areas and the impact on health-related quality of life (HRQOL) is sparse. The aim of this study was to assess HRQOL in children and their parents after participation in the programme ""A Healthy Generation"".
METHODS


The programme is delivered in socioeconomically disadvantaged areas in Sweden and offers physical activity and a healthy meal or fruit twice a week from August to May to families with children in grade 2. Children (n = 67), aged 8-9 years, and their parents (n = 90) participated in this controlled study conducted in four schools, two control and two intervention schools. HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively. Analyses of covariance (ANCOVAs), linear regression and Pearson's correlation were conducted.
RESULTS


There were no significant differences between intervention and control in HRQOL among children or adults after the intervention. However, in a subgroup of children (n = 20) and adults (n = 29) with initial low HRQOL scores at baseline, there was a significant difference between the intervention group and control group after the intervention (children (total score): p = 0.02; adults (social domain) p = 0.04). Furthermore, within the intervention group, there was a significant relationship between level of participation in ""A Healthy Generation"" and the physical domain of HRQOL among girls (r = 0.44, p = 0.01), but not boys (r = - 0.07, p = 0.58).
CONCLUSION


Participation in the programme ""A Healthy Generation"" did not show a significant intervention effect on HRQOL in general. However, the findings suggest that HRQOL may be increased for children and adults with low HRQOL in disadvantaged areas. This knowledge can contribute to the development of health promoting interventions in such areas, and to more equitable health.
TRIAL REGISTRATION


ISRCTN ISRCTN11660938. Retrospectively registered 23 September 2019.",2020,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","['children and their parents after participation in the programme ""A Healthy Generation', 'children and adults with low HRQOL in disadvantaged areas', 'Children (n\u2009=\u200967), aged 8-9\u2009years, and their parents (n\u2009=\u200990) participated in this controlled study conducted in four schools, two control and two intervention schools']",['family intervention'],"['HRQOL', 'Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale', 'level of participation in ""A Healthy Generation"" and the physical domain of HRQOL', 'health-related quality of life-a healthy generation', 'initial low HRQOL scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0628145,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Susanne.andermo@ki.se.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Hedby', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, Stockholm, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC public health,['10.1186/s12889-020-08895-z']
2965,32471477,"Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial.","BACKGROUND


More than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.
METHODS


The Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).
DISCUSSION


Data on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity. If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.",2020,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"['patients with rheumatoid arthritis', 'Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity', 'Patients with rheumatoid arthritis suffer from debilitating symptoms']","['Cognitive behavioural therapy', 'nurse-led, group-based cognitive behavioural therapy', 'cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia or usual care']","['sleep\xa0onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms', 'sleep efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",60.0,0.0802292,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Latocha', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark. kristine.marie.latocha@regionh.dk.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Løppenthin', 'Affiliation': 'Department of Oncology, Research unit for Cancer Late Effect, CASTLE, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Jennum', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hetland', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Røgind', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lundbak', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Midtgaard', 'Affiliation': 'The University Hospitals Centre for Health Research, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}]",Trials,['10.1186/s13063-020-04282-6']
2966,32471478,Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial.,"BACKGROUND


Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment. Disclosure can lead to rejection and discrimination, but alternatively can also have important advantages that may be necessary to retain employment. Whether disclosure decisions lead to sustainable employment depends on many factors, of which unemployed people themselves can only influence their decision to disclose or not and the way in which they communicate. This study evaluates the cost-effectiveness of an intervention to support unemployed people with MHI in their disclosure decision and communication.
METHODS


This is a two-armed, clustered, randomized controlled trial with longitudinal design and randomization at organization level. An intervention will be examined, which consists of a disclosure decision aid tool (CORAL.NL) for unemployed people and workplace stigma-awareness training especially designed for employment specialists, which focusses on how to support unemployed people in their disclosure decisions. Participants in the intervention group are unemployed people who receive support from trained employment specialists from organizations allocated to the intervention group, and receive the CORAL.NL decision aid after baseline. The control group consists of unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group. Primary outcomes are: cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI. Secondary outcomes are mental health and wellbeing, stigma and discrimination and work-related factors. Financial income data are collected via the registration systems of Dutch municipalities and Statistics Netherlands, and by questionnaires at baseline, and at 3, 6 and 12 months.
DISCUSSION


If using a decision aid to decide about disclosure of MHI leads to people finding and retaining employment more often, this study will contribute to lowering healthcare and societal costs.
TRIAL REGISTRATION


Netherlands Trial Register: NL7798. Registered on 4 June 2019.",2020,"BACKGROUND


Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.",['unemployed people with MHI in their disclosure decision and communication'],['unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group'],"['cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI', 'cost-effectiveness', 'mental health and wellbeing, stigma and discrimination and work-related factors']","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.102735,"BACKGROUND


Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.","[{'ForeName': 'K M E', 'Initials': 'KME', 'LastName': 'Janssens', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands. k.m.e.janssens@tilburguniversity.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Weeghel', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'M C W', 'Initials': 'MCW', 'LastName': 'Joosen', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'E P M', 'Initials': 'EPM', 'LastName': 'Brouwers', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}]",Trials,['10.1186/s13063-020-04376-1']
2967,32471480,Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial.,"BACKGROUND


Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this intervention on muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores in this population.
METHODS


Thirty participants will be randomly distributed between 1) BFR-RT and 2) control (CTRL). Assessments will occur at three time points: before the training intervention (0 W), after 12 weeks (12 W), and at follow-up (24 W). The following variables will be assessed: Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length. The BFR-RT group will undergo 12 weeks of knee extension exercise (1 × 30 repetitions and 3 × 15 repetitions at 20% 1-RM and 50% of total blood flow occlusion pressure), with two sessions per week. Data normality will be assessed using the Shapiro-Wilk test. In case of normal distribution, a one-way repeated measures analysis of variance will be implemented to test for differences in baseline values. A mixed model then will be applied for each dependent variable. In case of non-normal data distribution, a Kruskal-Wallis test will be implemented to test for differences in baseline values. Next, the Friedman test will be used to analyze repeated measures. Within- and between-group effect sizes will be calculated using Cohen's d for each outcome. Finally, the minimal clinically important difference will be analyzed with distribution-based methods.
DISCUSSION


To our knowledge, this will be the first trial to investigate BFR-RT in patients with cirrhosis and evaluate the effects on neuromuscular parameters, functional performance, disease severity, and quality of life outcomes.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (ReBec): RBR-395mfw. Registered on 25 August 2018.",2020,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","['patients with cirrhosis', 'cirrhosis', 'Thirty participants will be randomly distributed between 1']","['BFR-RT and 2) control (CTRL', 'knee extension exercise', 'resistance training with blood flow restriction (BFR-RT', 'Resistance training combined with blood flow restriction']","['muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores', ""repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length"", 'neuromuscular parameters, functional performance, disease severity, and quality of life outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.0870044,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","[{'ForeName': 'Sanmy Rocha', 'Initials': 'SR', 'LastName': 'Nóbrega', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Silvana Gama Florencio', 'Initials': 'SGF', 'LastName': 'Chachá', 'Affiliation': 'Department of Medicine, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Cleiton Augusto', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil. c.libardi@ufscar.br.'}]",Trials,['10.1186/s13063-020-04410-2']
2968,32471492,Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial.,"BACKGROUND


Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom.
METHODS


This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework.
DISCUSSION


If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly.
TRIAL REGISTRATION


ISRCTN no: 17299295. Registered 1st October 2018.",2020,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"['Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria', 'primary care patients with depression (PROMDEP', '676 total participants from 113 practices across three centres', 'Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded']",['Patient Health Questionnaire (PHQ-9'],"['Patient satisfaction, quality of life (QALYs) and costs', 'BDI-II at 26\u2009weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26\u2009weeks, service use over 26\u2009weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26\u2009weeks (Medical Informant Satisfaction Scale', 'Depression on the Beck Depression Inventory BDI-II at 12\u2009weeks', 'depression, social functioning and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.232089,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK. A.R.Kendrick@soton.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Leydon', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, University Road Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dewar-Haggart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dowrick', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, L69 3GL, UK.'}]",Trials,['10.1186/s13063-020-04344-9']
2969,32471657,Effect of Sit-to-Stand Exercises Combined With Protein-Rich Oral Supplementation in Older Persons: The Older Person's Exercise and Nutrition Study.,"OBJECTIVES


Nursing home (NH) residents are often undernourished and physically inactive, which contributes to sarcopenia and frailty. The Older Person's Exercise and Nutrition Study aimed to investigate the effects of sit-to-stand exercises (STS) integrated into daily care, combined with a protein-rich oral nutritional supplement (ONS), on physical function, nutritional status, body composition, health-related quality of life, and resource use.
DESIGN


Residents in 8 NHs were randomized by NH units into an intervention group (IG) or a control group (CG) (n = 60/group). The IG was a combination of STS (4 times/day) and ONS (2 bottles/day providing 600 kcal and 36 g protein) for 12 weeks.
SETTING AND PARTICIPANTS


The participants resided in NH units (dementia and somatic care), were ≥75 years of age, and able to rise from a seated position.
METHODS


The 30-second Chair Stand Test was the primary outcome. Secondary outcomes were balance, walking speed, dependence in activities of daily living, nutritional status and body composition, health-related quality of life, and resource use.
RESULTS


Altogether, 102 residents (age 86 ± 5 years, 62% female) completed the study. No improvement in the physical function assessments was observed in the IG, whereas body weight increased significantly (2.05 ± 3.5 kg, P = .013) vs the CG. Twenty-one (of 52) participants with high adherence to the intervention (ie, at least 40% compliance to the combined intervention) increased their fat free mass (2.12 kg (0.13, 4.26 interquartile range), P = .007 vs CG). Logistic regression analyses indicated that the odds ratio for maintained/improved 30-second Chair Stand Test was 3.5 (confidence interval 1.1, 10.9, P = .034) among the participants with high adherence compared with the CG.
CONCLUSIONS/IMPLICATIONS


Twelve-week intervention of daily STS combined with ONS in NH residents did not improve physical function, but increased body weight. Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.",2020,Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.,"['102 residents (age 86\xa0±\xa05\xa0years, 62% female) completed the study', 'Residents in 8 NHs', 'Nursing home (NH) residents', 'Older Persons', 'participants resided in NH units (dementia and somatic care), were ≥75\xa0years of age, and able to rise from a seated position']","['control group (CG', 'Sit-to-Stand Exercises Combined With Protein-Rich Oral Supplementation', 'STS', 'sit-to-stand exercises (STS) integrated into daily care, combined with a protein-rich oral nutritional supplement (ONS', 'STS combined with ONS']","['physical function', 'body weight', 'physical function and a gain of fat free mass', 'fat free mass', 'balance, walking speed, dependence in activities of daily living, nutritional status and body composition, health-related quality of life, and resource use', 'odds ratio for maintained/improved 30-second Chair Stand Test', 'physical function assessments', 'physical function, nutritional status, body composition, health-related quality of life, and resource use']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",52.0,0.0601907,Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Grönstedt', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Allied Health Professionals, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Vikström', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Stockholm, Sweden; Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden; Theme Aging, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Allied Health Professionals, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvette C', 'Initials': 'YC', 'LastName': 'Luiking', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, the Netherlands.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Seiger', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wimo', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Faxén-Irving', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Allied Health Professionals, Function Area Clinical Nutrition, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Theme Aging, Karolinska University Hospital, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Nursing, Karolinska Institutet, Stockholm, Sweden; Western Norway University of Applied Sciences, Haugesund, Norway. Electronic address: anne-marie.bostrom@ki.se.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.030']
2970,32471729,Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.,"PURPOSE


To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
DESIGN


Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.
PARTICIPANTS


Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled.
METHODS


Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4).
MAIN OUTCOME MEASURES


The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs).
RESULTS


The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.
CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.",2020,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","['Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled', 'Neovascular Age-Related Macular Degeneration', '1888', 'Patients (n\xa0', 'naïve patients with neovascular age-related macular degeneration (AMD']","['topical corticosteroids', 'oral and/or injectable corticosteroids', 'Abicipar', 'ranibizumab 0.5 mg every 4 weeks (Q4', 'ranibizumab']","['Intraocular inflammation', 'change from baseline in BCVA and central retinal thickness (CRT', 'Efficacy and Safety', 'Incidence of intraocular inflammation (IOI) AEs', 'proportion of patients with stable vision', 'efficacy and safety', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",1888.0,0.237033,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: derek_kunimoto@yahoo.com.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Hansjürgen', 'Initials': 'H', 'LastName': 'Agostini', 'Affiliation': 'Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Souied', 'Affiliation': ""Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Chow', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada; Toronto Retina Institute, North York, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lotery', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Vision Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Le', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmidt', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Yehia', 'Initials': 'Y', 'LastName': 'Hashad', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.035']
2971,32471730,Usefulness of a circumferential wound retractor in emergency colorectal surgery as a preventive measure for surgical site infection. Alexis O-Ring® and emergency surgery.,"INTRODUCTION AND AIMS


More than 20% of healthcare-associated infections correspond to those at surgical sites, and there is a higher incidence of infections in colorectal surgery due to the associated bacterial load. Surgical wound protectors are designed to prevent contamination and mechanical trauma. Our aim was to demonstrate the usefulness of a circumferential wound retractor/protector for the prevention of surgical site infections (SSIs) in emergency colorectal surgery.
METHODS


Forty-one patients that underwent emergency open surgery at a tertiary care hospital were randomized into 2 groups: 20 cases without the retractor (group A) and 21 cases with the retractor (group B). Subjects were assigned to a group in a 1:1 randomization allocation ratio. The chi-square and Fisher's exact tests were employed for the quantitative variables, and the statistical analysis was performed using the IBM Statistical Package for the Social Sciences software for Mac, version 16.0 (IBM SPSS Inc., Chicago, IL, USA).
RESULTS


The SSI rate was 17%. Six group A patients developed SSI versus one group B patient. The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5. In addition, preoperative blood glucose levels below 200mg/dl provided a 3.2-times higher protective effect, compared with glucose levels above 200mg/dl.
CONCLUSIONS


In the present prospective randomized pilot study, the use of the circumferential wound retractor/protector significantly decreased the likelihood of SSI in emergency colorectal surgery.",2020,"The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5.","['Forty-one patients that underwent emergency open surgery at a tertiary care hospital were randomized into 2 groups: 20 cases without the retractor (group A) and 21 cases with the retractor (group B', 'emergency colorectal surgery']","['circumferential wound retractor', 'Surgical wound protectors', 'circumferential wound retractor/protector', 'Alexis O-Ring® and emergency surgery']","['SSI rate', 'surgical wound infections', 'preoperative blood glucose levels', 'likelihood of SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0445425', 'cui_str': 'Alexi'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",41.0,0.0384904,"The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Salgado-Nesme', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México. Electronic address: noelsalgadonesme@yahoo.com.mx.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morales-Cruz', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Navarro-Navarro', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Patiño-Gómez', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Vergara-Fernández', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}]",Revista de gastroenterologia de Mexico,['10.1016/j.rgmx.2019.08.009']
2972,32471770,The effect of diabetes education and short message service reminders on metabolic control and disease management in patients with type 2 diabetes mellitus.,"AIM


The aim of this study was to evaluate the effect of diabetes education and short message service reminders on metabolic control and disease management in patients with type 2 diabetes mellitus who were registered in a family health center and who were using oral antidiabetics.
METHODS


This pre-test and post-test control group interventional study was conducted between 2017 and 2019. For one-way analysis of variance, effect size=0.40, α=0.05 and 80% power for each group was considered to be appropriate for 48 participants. Considering probability of losses during the study, 101 patients with type-2 DM were selected to include in the study. At the beginning of the study of all the patients, metabolic (HbA1c, FBS, triglycerides, cholesterol, HDL, LDL), anthropometric (BMI), blood pressure (BP) and scales assessments were performed. The Follow-Up Form for Patients with Diabetes, Diabetes Self-Care Scale (DSCS) and World Health Organization (WHO) (5) Goodness Scale were used as data collection tools. In the study, the structured group-based education program consisting of five modules was given to the intervention group in two sessions. Immediately after the education program, short message reminders about diabetes management were sent twice a week for a six-month period to intervention group. During the study, each group was invited to the family health center to perform the third- and sixth-month evaluations. Data were analyzed by SPSS version 19. In the study, categorical variables were evaluated with Chi-squared test. The differences of the groups over time were evaluated using the Friedman test and binary comparisons of differences by Wilcoxon test. The changes among groups over time were evaluated by Mann-Whitney test.
RESULTS


In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
CONCLUSION


Diabetes education and SMS reminders sent for six months were effective in improving metabolic control and disease management in patients with type 2 diabetes mellitus.",2020,"In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
","['2017 and 2019', 'patients with type 2 diabetes mellitus who were registered in a family health center and who were using oral antidiabetics', 'patients with type 2 diabetes mellitus', '101 patients with type-2 DM']",['diabetes education and short message service reminders'],"['metabolic (HbA1c, FBS, triglycerides, cholesterol, HDL, LDL), anthropometric (BMI), blood pressure (BP) and scales assessments', 'Diabetes Self-Care Scale (DSCS) and World Health Organization (WHO', 'HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001', 'metabolic control and disease management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",101.0,0.0199426,"In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
","[{'ForeName': 'Türkan Akyol', 'Initials': 'TA', 'LastName': 'Güner', 'Affiliation': 'Faculty of Health Sciences, Department of Social Work, Zonguldak Bulent Ecevit University, Zonguldak, Turkey. Electronic address: turkanaguner@beun.edu.tr.'}, {'ForeName': 'Gülhan', 'Initials': 'G', 'LastName': 'Coşansu', 'Affiliation': 'Istanbul University Florance Nightingale Faculty of Nursing, Public Health Nursing Department, Istanbul, Turkey. Electronic address: gulhanc@istanbul.edu.tr.'}]",Primary care diabetes,['10.1016/j.pcd.2020.04.007']
2973,31875646,GDF15 mediates the effects of metformin on body weight and energy balance.,"Metformin, the world's most prescribed anti-diabetic drug, is also effective in preventing type 2 diabetes in people at high risk 1,2 . More than 60% of this effect is attributable to the ability of metformin to lower body weight in a sustained manner 3 . The molecular mechanisms by which metformin lowers body weight are unknown. Here we show-in two independent randomized controlled clinical trials-that metformin increases circulating levels of the peptide hormone growth/differentiation factor 15 (GDF15), which has been shown to reduce food intake and lower body weight through a brain-stem-restricted receptor. In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney. Metformin prevented weight gain in response to a high-fat diet in wild-type mice but not in mice lacking GDF15 or its receptor GDNF family receptor α-like (GFRAL). In obese mice on a high-fat diet, the effects of metformin to reduce body weight were reversed by a GFRAL-antagonist antibody. Metformin had effects on both energy intake and energy expenditure that were dependent on GDF15, but retained its ability to lower circulating glucose levels in the absence of GDF15 activity. In summary, metformin elevates circulating levels of GDF15, which is necessary to obtain its beneficial effects on energy balance and body weight, major contributors to its action as a chemopreventive agent.",2020,"In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney.",[],"['oral metformin', 'Metformin', 'metformin']","['circulating GDF15, with GDF15 expression', 'body weight', 'weight gain', 'energy intake and energy expenditure', 'body weight and energy balance']",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0132908,"In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. apc36@cam.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Pranali', 'Initials': 'P', 'LastName': 'Taskar', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rimmington', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Tadross', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cimino', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Virtue', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Goldspink', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Miedzybrodzka', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Konopka', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Raul Ruiz', 'Initials': 'RR', 'LastName': 'Esponda', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeffrey T-J', 'Initials': 'JT', 'LastName': 'Huang', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Y C Loraine', 'Initials': 'YCL', 'LastName': 'Tung', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Rodriguez-Cuenca', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rute A', 'Initials': 'RA', 'LastName': 'Tomaz', 'Affiliation': 'Wellcome -Medical Research Council Cambridge Stem Cell Institute, Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Heather P', 'Initials': 'HP', 'LastName': 'Harding', 'Affiliation': 'Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Melvin', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Giles S H', 'Initials': 'GSH', 'LastName': 'Yeo', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preiss', 'Affiliation': 'MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vidal-Puig', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Vallier', 'Affiliation': 'Wellcome -Medical Research Council Cambridge Stem Cell Institute, Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ron', 'Affiliation': 'Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Savage', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Bernard B', 'Initials': 'BB', 'LastName': 'Allan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Rahilly"", 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. so104@medschl.cam.ac.uk.'}]",Nature,['10.1038/s41586-019-1911-y']
2974,32471514,Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study.,"BACKGROUND


Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
AIMS AND OBJECTIVES


To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation.
OBJECTIVES


1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff.
METHODS


A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service.
DISCUSSION


Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions.
TRIAL REGISTRATION


ISRCTN17847169. Date registered: 15 December 2017.",2020,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
",[],['relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training'],['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4542877', 'cui_str': 'Pharmacist prescriber'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0796992,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bond', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK. c.m.bond@abdn.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, University of Leicester, Leicester, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Alldred', 'Affiliation': 'School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Arthur', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Birt', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Blyth', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Handford', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Athena Care Homes, Unit 2 Rima House, A13 Approach, Ripple Road, Barking, Essex, IG11 0RH, UK.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Maskrey', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Massey', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Norris', 'Affiliation': 'School of Education & Lifelong Learning University of East Anglia, Norwich, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Zermansky', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04264-8']
2975,32471645,Effect of zymomonas mobilis probiotic on cholesterol and its lipoprotein fractions and the intestinal regulation.,"Zymomonas mobilis have characteristics that classify it as probiotic. Thus, this study aimed to evaluate the effect of regular consumption of fermented broth of this strain on the intestinal function of individuals with changes in intestinal transit. This is a randomized, descriptive and quantitative clinical trial, a sample composed of undergraduate students from a university center in Caruaru. After screening for individuals with constipation according to the inclusion and exclusion criteria, only 13 agreed to participate in the study. They were divided into groups: group 1 received Zymomonas mobilis fermented broth once a day; group 2 also received the fermented broth in the same concentration cells being twice a day; group 3 received cell-free fermented broth once daily; and group 4, placebo, received saline once daily, all groups drank for fifteen days, and laboratory tests were performed to check lipid profile before and after that period. Observed an increase in evacuation days in all groups averaged in media 7.0-10.5 days. Groups 1 and 2 showed an increase in total cholesterol (0.5% and 5.0%, respectively), HDL cholesterol (4.1% and 24.1%), LDL cholesterol (4.9% and 8.4%), VLDL cholesterol (17.9% and 11.2%) and triglycerides (19.1% and 27.9%). In group 3, there was a reduction of total cholesterol (-2.4%), LDL cholesterol (-11.2%), VLDL cholesterol (-15.9%), triglycerides (-27.7%) and increase in HDL cholesterol (25.7%). Thus, the broth fermented with Zymomonas mobilis regulated the intestinal transit, but did not improve the lipid profile, while the without cells broth showed a better lipid profile.",2020,"Groups 1 and 2 showed an increase in total cholesterol (0.5% and 5.0%, respectively), HDL cholesterol (4.1% and 24.1%), LDL cholesterol (4.9% and 8.4%), VLDL cholesterol (17.9% and 11.2%) and triglycerides (19.1% and 27.9%).","['undergraduate students from a university center in Caruaru', 'individuals with constipation according to the inclusion and exclusion criteria, only 13 agreed to participate in the study', 'individuals with changes in intestinal transit']","['Zymomonas mobilis fermented broth once a day; group 2 also received the fermented broth in the same concentration cells being twice a day; group 3 received cell-free fermented broth once daily; and group 4, placebo, received saline', 'zymomonas mobilis probiotic']","['triglycerides', 'total cholesterol', 'intestinal transit', 'evacuation days', 'LDL cholesterol', 'VLDL cholesterol', 'HDL cholesterol', 'cholesterol and its lipoprotein fractions and the intestinal regulation', 'lipid profile']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1301827', 'cui_str': 'In transit'}]","[{'cui': 'C0162736', 'cui_str': 'Zymomonas mobilis'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.0364793,"Groups 1 and 2 showed an increase in total cholesterol (0.5% and 5.0%, respectively), HDL cholesterol (4.1% and 24.1%), LDL cholesterol (4.9% and 8.4%), VLDL cholesterol (17.9% and 11.2%) and triglycerides (19.1% and 27.9%).","[{'ForeName': 'Andreza', 'Initials': 'A', 'LastName': 'Tallyne de Aguiar Silva', 'Affiliation': 'Lato Sensu Multiprofessional Residence Program in Cancer Attention and Palliative Care, University Center Tabosa of Almeida (ASCES-UNITA), Caruaru, Pernambuco, Brazil. Electronic address: andrezathallyne@hotmail.com.'}, {'ForeName': 'Iago Dillion', 'Initials': 'ID', 'LastName': 'Lima Cavalcanti', 'Affiliation': 'Lato Sensu Multiprofessional Residence Program in Cancer Attention and Palliative Care, University Center Tabosa of Almeida (ASCES-UNITA), Caruaru, Pernambuco, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ayanny de Lima Fernandes', 'Affiliation': 'Lato Sensu Multiprofessional Residence Program in Cancer Attention and Palliative Care, University Center Tabosa of Almeida (ASCES-UNITA), Caruaru, Pernambuco, Brazil.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gisele de Oliveira Coimbra', 'Affiliation': 'University Center Tabosa of Almeida (ASCES-UNITA), Caruaru, Pernambuco, Brazil.'}, {'ForeName': 'Gláucia', 'Initials': 'G', 'LastName': 'Manoella de Souza Lima', 'Affiliation': 'Department of Antibiotics - Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.04.002']
2976,32039716,Association between stigma towards HIV and MSM and intimate partner violence among newly HIV-diagnosed Chinese men who have sex with men.,"BACKGROUND


HIV- and MSM-related stigma are well documented as common for Chinese men who have sex with men (MSM) living with HIV, yet there is sparse literature on intimate partner violence (IPV) and its relationship with stigma in this vulnerable population. To evaluate the association between HIV-stigma and stigma related to homosexuality and IPV among newly HIV-diagnosed MSM in China.
METHODS


Data were collected in the baseline survey among newly HIV-diagnosed Chinese MSM in a randomized clinical trial via face-to-face interviews. Univariate logistic and multivariate logistic regression analyses were performed to assess the associations between IPV and HIV- and MSM-related stigma.
RESULTS


Of 367 newly HIV-diagnosed Chinese MSM, 23.7% experienced any IPV, including 16.6% physical, 7.4% psychological and 5.2% sexual IPV. Positive associations were found between HIV- and MSM-related stigma and IPV. Men with high HIV-related stigma (score ≥ 27) were 1.67 times as likely to experience any IPV as those with low stigma (adjusted odds ratio [AOR]: 1.67, 95% confidence interval [CI]: 1.02-2.76). Men with high MSM-related stigma (score ≥ 6) were 1.99 times as likely to experience any IPV as those with low stigma (AOR: 1.99, 95% CI: 1.18-3.36).
CONCLUSIONS


HIV- and MSM-related stigmas was positively associated with IPV experiences among newly diagnosed MSM in China. The manner in which stigma may exacerbate IPV, and/or the influence of IPV on worsening stigma should be further evaluated. The high prevalence of IPV and stigma in this population suggests that interventions should be taken to reduce stigma and prevent this risky behavior among MSM.",2020,"Men with high HIV-related stigma (score ≥ 27) were 1.67 times as likely to experience any IPV as those with low stigma (adjusted odds ratio [AOR]: 1.67, 95% confidence interval [CI]: 1.02-2.76).","['Data were collected in the baseline survey among newly HIV-diagnosed Chinese MSM in a randomized clinical trial via face-to-face interviews', 'Chinese men who have sex with men (MSM) living with HIV', 'newly HIV-diagnosed Chinese men who have sex with men', 'newly HIV-diagnosed MSM in China']",[],['stigma towards HIV and MSM and intimate partner violence'],"[{'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",367.0,0.06585,"Men with high HIV-related stigma (score ≥ 27) were 1.67 times as likely to experience any IPV as those with low stigma (adjusted odds ratio [AOR]: 1.67, 95% confidence interval [CI]: 1.02-2.76).","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Guilin Medical University, Guilin, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'School of Public Health, Guilin Medical University, Guilin, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sten H', 'Initials': 'SH', 'LastName': 'Vermund', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Biostatistics and Epidemiology, College of Public Health, East Tennessee State University, Johnson City, TN, USA.'}, {'ForeName': 'Han-Zhu', 'Initials': 'HZ', 'LastName': 'Qian', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, USA. han-zhu.qian@yale.edu.'}]",BMC public health,['10.1186/s12889-020-8259-y']
2977,32039721,An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.,"BACKGROUND


Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and short visits with inconsistent provisioning of essential services and minimal health promotion, especially for HIV prevention. This study answers WHO's call for the rigorous study of group antenatal care as a transformative model that provides a positive pregnancy experience and improves outcomes.
METHODS


Using a hybrid type 1 effectiveness-implementation design, we test the effectiveness of group antenatal care by comparing it to individual care across 6 clinics in Blantyre District, Malawi. Our first aim is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We will test hypotheses using multi-level hierarchical models using data from repeated surveys (four time points) and health records. Guided by the consolidated framework for implementation research, our second aim is to identify contextual factors related to clinic-level degree of implementation success. Analyses use within and across-case matrices.
DISCUSSION


This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care. Results will provide rigorous evidence documenting the effectiveness and scalability of group antenatal care. If results are negative, governments will avoid spending on less effective care. If our study shows positive health impacts in Malawi, the results will provide strong evidence and valuable lessons learned for widespread scale-up in other low-resource settings. Positive maternal, neonatal, and HIV-related outcomes will save lives, impact the quality of antenatal care, and influence health policy as governments make decisions about whether to adopt this innovative healthcare model.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT03673709. Registered on September 17, 2018.",2020,"This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care.",['Malawi'],[],"['quality of antenatal care', 'morbidity and mortality']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0663342,"This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Esnath', 'Initials': 'E', 'LastName': 'Kapito', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Jere', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Kafulafula', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chodzaza', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Genesis', 'Initials': 'G', 'LastName': 'Chorwe-Sungani', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Gresh', 'Affiliation': 'Johns Hopkins University, School of Nursing, 525 North Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, 1603 W. Taylor Street (M/C 932), Chicago, IL, 60612, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Abrams', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Carrie S', 'Initials': 'CS', 'LastName': 'Klima', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'McCreary', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Patil', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA. cpatil@uic.edu.'}]",BMC public health,['10.1186/s12889-020-8276-x']
2978,32245307,"Effect of Guluronic Acid (G2013), As a New Anti-inflammatory Drug on Gene Expression of Pro-inflammatory and Anti-inflammatory Cytokines and Their Transcription Factors in Rheumatoid Arthritis Patients.","Rheumatoid arthritis (RA) as a long-term autoimmune disease is characterized by pain, swelling and joints destruction. The therapeutic efficacy of Guluronic acid (G2013) (patented, DEU: 102016113017.6) was reported in phase I/II clinical trial in RA patients. In this study, we aimed to evaluate the effect of G2013 as a novel non-steroidal anti-inflammatory drug (NSAID) with immunosuppressive property on genes expression of anti-inflammatory and pro-inflammatory cytokines and their transcription factors in the blood sample of RA patients. This study was performed on 12 patients with RA who had an inadequate response to conventional treatments which were disease-modifying anti-rheumatic drugs (DMARDs), NSAID, and biologics. G2013 was administered orally at a dose of 500 mg twice daily for 12 weeks. Before and after the treatment of patients with drug G2013, the peripheral blood mononuclear cells (PBMCs) were isolated for evaluating the gene expression level of interleukin 10 (IL10), interleukin 22 (IL22), interferon γ (IFNγ), and transcription factors specific to the T helper cell lineages, forkhead box P3 (Fox-P3), Aryl hydrocarbon receptor (AHR) and T-box-containing protein expressed in T cells (T-bet) using the real-time PCR method. Since these cytokines have a key role in the progression of RA and disease condition expected induction of IFNγ, AHR, IL22, T-bet, and reduction of IL10, Fox-P3. Results indicated a significant reduction in the level of IFNγ, AHR and a significant induction in IL10, Fox-P3 gene expression in comparison with the control group. In conclusion; the results of this investigation showed a part of the immunological mechanism of G2013 as a novel anti-inflammatory that could reduce pro-inflammatory cytokine and their transcription factors. Furthermore, it increased the anti-inflammatory cytokine and its transcription factor (clinical trial identifier: IRCT2016092813739N5).",2019,"Results indicated a significant reduction in the level of IFNγ, AHR and a significant induction in IL10, Fox-P3 gene expression in comparison with the control group.","['12 patients with RA who had an inadequate response to conventional treatments which were disease-modifying anti-rheumatic drugs (DMARDs), NSAID, and biologics', 'RA patients', 'Rheumatoid Arthritis Patients', 'blood sample of RA patients']","['Guluronic Acid (G2013', 'Guluronic acid (G2013) (patented, DEU']","['peripheral blood mononuclear cells (PBMCs', 'level of IFNγ, AHR and a significant induction in IL10, Fox-P3 gene expression', 'gene expression level of interleukin 10 (IL10), interleukin 22 (IL22), interferon γ (IFNγ), and transcription factors specific to the T helper cell lineages, forkhead box P3 (Fox-P3), Aryl hydrocarbon receptor (AHR) and T-box-containing protein expressed in T cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]","[{'cui': 'C0120505', 'cui_str': 'guluronic acid'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0017477', 'cui_str': 'German language'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0052441', 'cui_str': 'Aryl Hydrocarbon Receptor'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",12.0,0.0247477,"Results indicated a significant reduction in the level of IFNγ, AHR and a significant induction in IL10, Fox-P3 gene expression in comparison with the control group.","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bakhtiari', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. tahereh.bakhtiari361@gmail.com.'}, {'ForeName': 'ShahinKhadem', 'Initials': 'S', 'LastName': 'Azarian', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. mirshafiey@tums.ac.ir.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology Ward, Cancer Research Centre, Cancer Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. mirshafiey@tums.ac.ir.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Ahmadzadeh', 'Affiliation': 'Department of Rheumatology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mirshafiey@tums.ac.ir.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mirshafiey', 'Affiliation': ""Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran AND Research Center for Immunodeficiencies, Children's Medical Centre, Tehran University of Medical Sciences, Tehran, Iran. mirshafiey@tums.ac.ir.""}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v18i6.2176']
2979,32302671,Editorial: Research in Real-World Settings: Challenging the Limits of Experimental Design.,"As underscored by Ponguta and colleagues in this issue of the Journal, 1  displacement secondary to war, poverty, and unsafe living conditions has affected large segments of the world's population, placing millions of children and their parents in highly stressful living conditions. Positive parenting, parenting that is warm, loving, and responsive to a child's needs, can mitigate the negative effects of early adversity and poverty on a child's behavioral, emotional, and cognitive development 2-4  and is one factor that can be targeted in otherwise almost immutable circumstances. Programs to support parents and to enhance positive parenting skills have proved effective across multiple countries and environments, including low- and middle-income countries 5 ; however, efforts to rigorously test these programs in areas of highest need and psychosocial instability are rare. By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend. Their work is an outstanding example of an effort to apply a rigorous scientific approach in a real-world setting underscoring both the value and the challenges inherent in this work.",2020,"By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend.","['two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend']",['Mother and Child Education Program (MOECP'],[],"[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0040833', 'cui_str': 'trends'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],,0.0251656,"By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': ""University of Washington School of Medicine and Seattle Children's Hospital, Seattle. Electronic address: eliz@uw.edu.""}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Novins', 'Affiliation': 'University of Colorado School of Medicine, Aurora.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.04.002']
2980,30721390,Observational study of newborn infant parasympathetic evaluation as a comfort system in awake patients admitted to a pediatric intensive care unit.,"To compare the newborn infant parasympathetic evaluation system (NIPE) scores with a validated clinical scale using two different nebulizers in children with bronchiolitis admitted to a PICU. Comfort was evaluated using the COMFORT-behavior scale (CBS) before (T1), during (T2) and after (T3) each nebulization. In order to compare NIPE and CBS values during the whole T1 to T3 period, the variable Dif-CBS was defined as the difference between maximal and minimal CBS scores, and Dif-NIPE as the difference between 75th and 25th percentile NIPE values. Analyses were carried out, firstly for the total of nebulizations and secondly comparing two different nebulization systems: a jet nebulizer (JN) and a nebulizer integrated in high flow nasal cannulas (NHF). 84 nebulizations were recorded on 14 patients with a median [25th-75th percentile] age of 6 months (3.1-9.5). A Dif-CBS of 4 points (2-7), as well as changes in CBS scores between T1 and T2, defined the nebulization as a discomfort stimulus. The NIPE system, represented as the Dif-NIPE, showed a median variation of 9 points (7-10), and was poorly correlated to Dif-CBS [r s  0.162 (P = 0.142)]. Discomfort during nebulization, assessed by CBS was greater with the JN system compared to NHF: 17 (13-22) vs 13 (9-15) (P = 0.001). NIPE monitoring detected no significant differences between both nebulization systems (P = 0.706). NIPE monitoring showed a variation in comfort during nebulization in the patient with bronchiolitis, though correlation with CBS was poor. Further research is required before NIPE can be suggested as a comfort monitoring system for the awake infant.",2019,"Analyses were carried out, firstly for the total of nebulizations and secondly comparing two different nebulization systems: a jet nebulizer (JN) and a nebulizer integrated in high flow nasal cannulas (NHF).","['awake patients admitted to a pediatric intensive care unit', 'children with bronchiolitis admitted to a PICU', '84 nebulizations were recorded on 14 patients with a median [25th-75th percentile] age of 6 months (3.1-9.5']","['newborn infant parasympathetic evaluation', 'jet nebulizer (JN) and a nebulizer integrated in high flow nasal cannulas (NHF', 'NHF']","['Discomfort', 'NIPE and CBS values', 'newborn infant parasympathetic evaluation system (NIPE) scores', 'maximal and minimal CBS scores, and Dif-NIPE', 'COMFORT-behavior scale (CBS', 'CBS scores', 'CBS']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4517899', 'cui_str': '9.5'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",84.0,0.0132077,"Analyses were carried out, firstly for the total of nebulizations and secondly comparing two different nebulization systems: a jet nebulizer (JN) and a nebulizer integrated in high flow nasal cannulas (NHF).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Valencia-Ramos', 'Affiliation': 'Pediatric Intensive Care Unit, Burgos University Hospital, Avenida Islas Baleares s/n, CP 09006, Burgos, Spain. jvalenra@gmail.com.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Arnaez', 'Affiliation': 'Department of Neonatology, Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Calvo', 'Affiliation': 'Research Unit, Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomez', 'Affiliation': 'Pediatric Intensive Care Unit, Burgos University Hospital, Avenida Islas Baleares s/n, CP 09006, Burgos, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del Blanco', 'Affiliation': 'Pediatric Intensive Care Unit, Burgos University Hospital, Avenida Islas Baleares s/n, CP 09006, Burgos, Spain.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00268-1']
2981,32473040,Learning curve of double-guidewire technique by trainees during hands-on ERCP training.,"BACKGROUND & AIMS


Double-guidewire technique (DWT) has been successfully performed by experts in difficult biliary cannulation as an advanced technique. This study aimed to define the learning curve and safety of DWT by trainees during hands-on endoscopic retrograde cholangiopancreatography (ERCP) training.
METHODS


Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct (PD) was inadvertently cannulated. DWT was performed by two trainees randomly under trainers' guidance. The primary outcome was the success rate of DWT biliary cannulation of trainees. Cumulative sum analysis was used to generate visual learning curves.
RESULTS


A total of 60 patients with difficult cannulation were enrolled. The main indications for ERCP were common bile duct stones (65%) and biliary stricture (31.7%). The learning curve analysis showed that to achieve a 70% rate of successful DWT, 12 procedures were needed for trainee A and 15 for trainee B. Higher targeted success rate of DWT could be achieved if the number of DWT procedures increased. Compared with the early stage of learning DWT (case 1 to 15 for each trainee), trainees had significantly higher DWT success rate in the late stage (36.7% (11/30) vs. 80% (24/30), p=0.001). The final success rate of cannulation was 98.3% (59/60). The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60) respectively.
CONCLUSIONS


DWT was safely performed by two novel trainees during hands-on ERCP training. Fifteen procedures may be enough for trainees to achieve the competency of performing DWT. (Clinicaltrials.gov number: NCT03707613).",2020,"The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60) respectively.
","['Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct (PD) was inadvertently cannulated', '60 patients with difficult cannulation were enrolled']","['endoscopic retrograde cholangiopancreatography (ERCP) training', 'Double-guidewire technique (DWT']","['success rate of DWT biliary cannulation of trainees', 'overall rate of post-ERCP pancreatitis and adverse events', 'biliary stricture', 'final success rate of cannulation', 'bile duct stones', 'DWT success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}]","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct'}]",60.0,0.0909091,"The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60) respectively.
","[{'ForeName': 'Xiangping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Gui', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': ""Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Biaoluo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Qin', 'Affiliation': ""Department of General Surgery, First Affiliated Hospital of Xian Jiaotong University, Xi'an, China.""}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Farrell', 'Affiliation': 'Department of Digestive Disease and Yale Center for Pancreatic Disease, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xuegang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15120']
2982,32473084,"A randomized, single-blinded, vehicle-controlled study of a topical active blend in the treatment of androgenetic alopecia.","INTRODUCTION


Αndrogenetic alopecia (AGA) is the most common hair disorder, affecting approximately 50% of men and women. A topical lotion that contains two patented formulas (Redensyl® and Sepicontrol A5®), has been introduced as an alternative approach to standard therapies for AGA.
METHODS


Forty-four patients with AGA were randomized either to apply the active lotion or the vehicle, twice daily for 24 weeks. Subjects were evaluated at 0, 12, and 24 weeks by clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen to telogen ratio).
RESULTS


Forty-one patients, 18 males and 23 females, completed the study. Among patients receiving active treatment (n=26), 7.7% had great improvement, 73.1% had moderate improvement and 19.2% remained stable. The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001). The median anagen to telogen ratio increased from 2.25 to 4.00 to 6.02 at week 0, 12 and 24, respectively. No significant adverse events were reported.
CONCLUSION


This new topical active blend is effective in the treatment of AGA, with high degree of patients' satisfaction, improvement of quality of life, and an excellent safety profile. Thus, it may represent a useful alternative therapeutic approach for AGA. This article is protected by copyright. All rights reserved.",2020,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","['Forty-four patients with AGA', 'Forty-one patients, 18 males and 23 females', 'androgenetic alopecia']",['active lotion'],"['median self-assessment score', 'DLQI', 'clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen to telogen ratio', 'adverse events', 'median anagen to telogen ratio']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0519989', 'cui_str': 'Hair pluck test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0689808,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Katoulis', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Aikaterini I', 'Initials': 'AI', 'LastName': 'Liakou', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Koumaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Vakirlis', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Andreas G', 'Initials': 'AG', 'LastName': 'Tsantes', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Mortaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Bozi', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Ioannidis', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}]",Dermatologic therapy,['10.1111/dth.13734']
2983,32473139,Death threats after a trial on chloroquine for COVID-19.,,2020,,[],['chloroquine'],[],[],"[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}]",[],,0.11026,,"[{'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Ektorp', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30383-2']
2984,32473149,Linear Growth between Early and Late Childhood and Cognitive Outcomes at 6 to 9 Years of Age.,"OBJECTIVES


To assess the extent to which linear growth beyond the early years of life determines later cognitive development.
STUDY DESIGN


We revisited children from New Delhi, India who had participated in a randomized controlled trial six years before and assessed neurodevelopment using standardized and validated psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II). The associations of change in height for age z scores (HAZ) between early (12-36 months) and late (6-9 years) childhood with cognitive outcomes at 6-9 years of age were explored using linear regression models, after adjustment for appropriate confounders.
RESULTS


Out of the 1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up. HAZ in the first two years of life was significantly associated with both the WISC-CVS [standardized beta coefficient (ẞ) 0.15, 95% CI: 0.08, 0.23], and the NEPSY-II z-score [ẞ 0.09, 95% CI: 0.03, 0.18] at 6-9 years of age. There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
CONCLUSION(S)


Linear growth between early and late childhood is not associated with later cognitive outcomes. Our findings support the current practice of investing public health efforts to accelerate linear growth in the first 2-3 years of life.",2020,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","['revisited children from New Delhi, India who had participated', '1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up']",['HAZ'],"['psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II', 'HAZ scores', 'Linear Growth between Early and Late Childhood and Cognitive Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0451093', 'cui_str': 'Crichton vocabulary scale'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0581295,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","[{'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi; Centre for International Health, University of Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway. Electronic address: sunita.taneja@sas.org.in.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.043']
2985,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND


In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion.
OBJECTIVES


The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population.
METHODS


A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline.
RESULTS


During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters.
CONCLUSION


These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983']
2986,32473356,Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.,"BACKGROUND


Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12  receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
METHODS


Assessment of Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
CONCLUSION


ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.",2020,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"['patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290', 'patients with stable coronary artery disease who are planned for an elective PCI', '1,900 patients', 'patients undergoing elective percutaneous coronary intervention (PCI']","['Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel', 'ticagrelor 180 mg or a loading dose of clopidogrel', 'aspirin', 'aspirin and ticagrelor 90 mg twice daily or clopidogrel']","['PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier', 'periprocedural ischemic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1900.0,0.0455808,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen-Département de Cardiologie; Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'CH de Chartres-Département de Cardiologie, Chartes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Department of Cardiology, Inserm U942, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'CH de Bastia-Département de Cardiologie, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion-Département de Cardiologie, La Réunion, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'CHU de Poitiers-Service de Cardiologie, Poitiers, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'CHU de Toulouse-Département de Cardiologie, Toulouse, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Georges', 'Affiliation': 'CH de Versailles-Service de Cardiologie, Hôpital A. Mignot, Le Chesnay, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellemain-Appaix', 'Affiliation': ""CH d'Antibes Juan-Les-Pins-Département de Cardiologie, Antibes Juan-Les-Pins, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Univ Rennes, CHU Rennes, Inserm LTSI U1099, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'CHU Ambroise Paré (APHP), Université Versailles-Saint Quentin, ACTION study Group, INSERM-U1018 CESP, Boulogne, France-Service de Cardiologie.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'CHU Trousseau, Tours-Département de Cardiologie, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste Montsouris-Département de Cardiologie, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jourda', 'Affiliation': 'CH Auxerre-Département de Cardiologie, Auxerre, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': '3rd Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Grand Hôpital de l'Est Francilien site Marne-La-Vallée - Département de Cardiologie, Marne La Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation center, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), DHU FIRE, Hôpital Bichat, AP-HP, Université de Paris, Inserm U-1148, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), Paris, France; SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.017']
2987,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE


Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential.
MATERIALS AND METHODS


MLE tradename Zynamite is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied.
RESULTS


Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05.
CONCLUSIONS


Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996']
2988,32473378,nAnnexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure.,"OBJECTIVES


The study sought to identify the role of Annexin A1 as a congestion marker in acute heart failure, and to identify its putative role in predicting clinical outcomes.
BACKGROUND


Annexin A1 (AnxA1) is a protein that inhibits inflammation following ischemia-reperfusion (I-R) injury in cardiorenal tissues. Since acute heart failure (AHF) is a state of tissue hypoperfusion, we hypothesized that plasma AnxA1 levels are altered in AHF.
METHODS


In The Renal Optimization Strategies Evaluation (ROSE) trial, patients hospitalized for AHF with kidney injury were randomized to receive dopamine, nesiritide, or placebo for 72 hours in addition to diuresis. In a sub-analysis, plasma AnxA1 levels were measured at baseline and at 72 hours in 275 patients. Participants were divided into three tertiles based on their baseline AnxA1 levels.
RESULTS


The prevalence of peripheral edema 2+ increased with increasing AnxA1 levels (p < 0.007). Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05). Patients with a congestion score of 4 had a mean baseline AnxA1 level 8.63 units higher than those with a congestion score of 0 (p= 0.03). Patients in tertiles 2 and 3 were twice as likely to experience creatinine elevation as patients in tertile 1 (p= 0.03). Patients in tertiles 2 and 3 were at a higher risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality (p <0.05).
CONCLUSIONS


Among patients hospitalized for AHF with impaired kidney function, elevated AnxA1 levels are associated with worse congestion, higher risk for further creatinine elevation, and higher rates of 60-day morbidity or all-cause mortality & 180-day all-cause mortality.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01132846.",2020,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).",['patients hospitalized for AHF with kidney injury'],"['dopamine, nesiritide, or placebo', 'nAnnexin A1', 'Annexin A1']","['plasma AnxA1 levels', '60-day morbidity', 'Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels', 'risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality', 'experience creatinine elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.20289,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).","[{'ForeName': 'Fadi W', 'Initials': 'FW', 'LastName': 'Adel', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Rikhi', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Siu-Hin', 'Initials': 'SH', 'LastName': 'Wan', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Seethalakshmi R', 'Initials': 'SR', 'LastName': 'Iyer', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address: Chen.Horng@mayo.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.05.012']
2989,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
2990,31828050,"A Prospective, Randomized Comparison of Duodenoscope Reprocessing Surveillance Methods.","Duodenoscope use in healthcare facilities has been associated with transmission of multidrug resistant pathogens between patients. To assist healthcare facilities in monitoring the quality of their duodenoscope reprocessing procedures and limit patient risk of infection, the Centers for Disease Control and Prevention (CDC) deployed voluntary interim duodenoscope sampling and culturing surveillance protocols in 2015. Though the interim methods were widely adopted, alternative surveillance protocols were developed and implemented at individual institutions. Here, we compared two sampling methods-the 2015 CDC interim protocol and an alternative protocol developed by the University of Wisconsin Hospitals and Clinics (UWHC). We hypothesized that the UWHC protocol would detect a higher incidence of bacterial contamination from reprocessed duodenoscopes. A total of 248 sampling events were performed at UWHC. The CDC protocol ( n  = 129 sampling events) required culturing samples collected from each duodenoscope after brushing its terminal end and flushing its lumen with sterile water. The UWHC protocol ( n  = 119 sampling events) required culturing samples collected from each duodenoscope after swabbing its elevator, immersing its terminal end into broth and flushing its lumen with saline. With the CDC method, 8.53% ( n  = 11) of the duodenoscopes sampled were positive for bacterial growth with 15 isolates recovered. Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered. The relative risk of identifying a contaminated duodenoscope using the CDC interim method, however, was not different than when using the UWHC protocol. Mean processing time (27.35 and 5.11 minutes,  p  < 0.001) and total cost per sample event ($17.87 and $15.04) were lower using the UWHC method. As the UWHC protocol provides similar detection rates as the CDC protocol, the UWHC method is useful, provided the shorter processing time and lower cost to perform.",2019,"Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered.",[],[],"['total cost per sample event', 'Mean processing time']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241301,"Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered.","[{'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'De Wolfe', 'Affiliation': 'Department of Biomedical Informatics, University of Pittsburgh School of Medicine, Pittsburgh 15219, PA, USA.'}, {'ForeName': 'Nasia', 'Initials': 'N', 'LastName': 'Safdar', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Meller', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': 'Infection Control, University of Wisconsin Hospitals and Clinics, Madison 53705, WI, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Pfau', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Nelsen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Benson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reichelderfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Duster', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'Deepak V', 'Initials': 'DV', 'LastName': 'Gopal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}]",Canadian journal of gastroenterology & hepatology,['10.1155/2019/1959141']
2991,32473216,"High-School Students Can Stop the Bleed: A Randomized, Controlled Educational Trial.","OBJECTIVE


To determine high school students' ability to learn hemorrhage control skills and knowledge via three educational modalities.
BACKGROUND


Trauma is the leading cause of death for young Americans, and there are calls to teach children about hemorrhage control. However, little is known about adolescents' ability to perform hemorrhage control, and the ideal way(s) to teach them.
METHODS


This randomized controlled trial enrolled high-school students from 39 states at a 2019 national conference. After answering questions about their willingness to use tourniquets, participants received hemorrhage control education in one of three formats: instructor-led, web-only, or blended (combining web and instructor-led). Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet. Finally, they completed an attitude questionnaire.
RESULTS


204 (82%) of 248 participants applied a tourniquet correctly: 72 (88%) instructor-led, 50 (61%) web-only, and 79 (94%) blended. The instructor-led and blended arms were superior to the web-only arm (P < .001). Nearly all participants passed an assessment requiring them to identify wounds warranting a tourniquet (99% instructor-led and blended, and 98% web-only). All modalities improved participants' self-reported willingness and comfort in using tourniquets P<.001).
CONCLUSIONS


This is the first study to demonstrate that high school students can learn hemorrhage control via multiple methods. Blended and instructor-led education led to highly successful skill performance. Students learned to identify wounds requiring tourniquets and showed an improved willingness to aid from all modalities. These findings should encourage educators to offer multiple educational modalities.",2020,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"['High-School Students Can Stop the Bleed', 'enrolled high-school students from 39 states at a 2019 national conference', 'high school students', 'young Americans']",[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],,0.114711,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': 'Department of Military & Emergency Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; National Center for Disaster Medicine & Public Health, Rockville, MD. Electronic address: craig.goolsby@usuhs.edu.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Rojas', 'Affiliation': 'National Center for Disaster Medicine & Public Health, Rockville, MD; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland.'}, {'ForeName': 'Raphaelle H', 'Initials': 'RH', 'LastName': 'Rodzik', 'Affiliation': 'National Center for Disaster Medicine & Public Health, Rockville, MD; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gausche-Hill', 'Affiliation': 'Los Angeles County Emergency Medical Services Agency, Los Angeles, CA; Departments of Emergency Medicine and Pediatrics, David Geffen School of Medicine at the University of California, Los Angeles; Departments of Emergency Medicine and Pediatrics, Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Departments of Surgery, Critical Care Medicine, and the Clinical and Translational Science Institute (CTSI), University of Pittsburgh; University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; Howard County Department of Fire and Rescue Services, Columbia, MD.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.012']
2992,32473275,Exploring the effects of an acute dose of antipsychotic medication on motivation-mediated BOLD activity using fMRI and a perceptual decision-making task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 hours later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035']
2993,32473338,Outcomes of the elective use of the chimney endovascular technique in pararenal aortic pathologic processes.,"OBJECTIVE


In the treatment of pararenal abdominal aortic aneurysms and aortic pathological processes (PAAs), the chimney EVAR (CHEVAR) represents an alternative technique for the urgent cases. Aim of the study was the evaluation of the outcomes of CHEVAR in the elective setting.
METHODS


We performed a retrospective analysis of the prospectively collected records of 165 consecutive asymptomatic CHEVAR patients, which were treated between March 2009 and January 2018 with the Endurant stent-graft (Medtronic, Santa-Rosa, CA, USA). A total of 244 chimney-grafts (CGs) were implanted. Primary endpoint was the clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis (>70%) of CGs and from any chimney technique related secondary procedure for the entire follow-up period. Secondary clinical success included patients with a successful treatment of a primary endpoint with a secondary endovascular procedure.
RESULTS


All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n=13) including 3 (1.8%) cases of bowel ischemia, one (0.6%) patient with renal ischemia and one patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure related mortality rates were 1.8% (n=3). Primary and secondary freedom from persistent type Ia endoleak rates were 96.4% (n=159) and 99.4% (n=164), respectively. Primary and secondary chimney grafts patency rates were 92.2% (n=225) and 95.9% (n=234), respectively. The related with the chimney technique reinterventions rate was 10.9% (n=18) and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type Ia Endoleak were 87.5% and 95.3% respectively and the primary and secondary clinical successes rates at the mid-term were 80.3% and 87.5% respectively.
CONCLUSIONS


The elective use of CHEVAR technique with the Endurant stent-graft in our series showed favorable mid-term clinical results, which are similar with the published results of other total endovascular modalities. A prospective randomized trial of elective PAA's treatment with the current endovascular options is needed to assess the value of CHEVAR technique in the elective setting.",2020,"Primary endpoint was the clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis (>70%) of CGs and from any chimney technique related secondary procedure for the entire follow-up period.","['pararenal aortic pathologic processes', '165 consecutive asymptomatic CHEVAR patients, which were treated between March 2009 and January 2018 with the Endurant stent-graft (Medtronic, Santa-Rosa, CA, USA', 'A total of 244 chimney-grafts (CGs']","['chimney EVAR (CHEVAR', 'elective PAA', 'CHEVAR', 'chimney endovascular technique', 'CHEVAR technique with the Endurant stent-graft']","['persistent type Ia endoleak rates', 'mortality rates', 'cumulative primary patency and freedom from persistent type Ia Endoleak', 'chimney technique reinterventions rate', 'bowel ischemia', 'clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis', 'Total perioperative morbidity', 'secondary chimney grafts patency rates', 'renal ischemia']","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0030660', 'cui_str': 'Pathological process'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1504464', 'cui_str': 'Endoleak'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0156149', 'cui_str': 'Gastrointestinal tract vascular insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0920646', 'cui_str': 'Ischemia of kidney'}]",165.0,0.0322111,"Primary endpoint was the clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis (>70%) of CGs and from any chimney technique related secondary procedure for the entire follow-up period.","[{'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Pitoulias', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany; 2(nd) Department of Surgery - Division of Vascular Surgery, School Of Medicine - Aristotle University of Thessaloniki, ""G. Gennimatas"" Hospital, Thessaloniki, Greece. Electronic address: pitoulias@yahoo.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Torsello', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Austermann', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Apostolos G', 'Initials': 'AG', 'LastName': 'Pitoulias', 'Affiliation': '2(nd) Department of Surgery - Division of Vascular Surgery, School Of Medicine - Aristotle University of Thessaloniki, ""G. Gennimatas"" Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Marco D', 'Initials': 'MD', 'LastName': 'Pipitone', 'Affiliation': 'Vascular and Endovascular Surgery, Cardiovascular Department, University Hospital of Cattinara ASUITs, Trieste, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fazzini', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Donas', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Centre, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.05.029']
2994,32473355,TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.,"Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.",2020,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","['508 patients are required', 'CKD patients with ACS', 'CKD patients suffering from ACS', 'Patients with stage ≥3b', 'severe or terminal chronic kidney patients Undergoing', 'Chronic kidney disease (CKD', 'severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome', 'stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy']","['ticagrelor and clopidogrel', 'PERcutaneous coronary intervention', 'clopidogrel', 'TicagRelor Or Clopidogrel', 'ticagrelor']","['risk of thrombotic recurrences', 'rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0495371,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: marc.laine@ap-hm.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""Institut Cœur et Poumon, CHRU de Lille, Faculté de Médecine de l'Université de Lille, Unité INSERM UMR 1011, Lille, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Burtey', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France; Service de Néphrologie, Hôpital de la Conception, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Département de Cardiologie, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Département de Cardiologie, CHU Chartres, Chartres, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Quaino', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Canault', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': ""Service de Cardiologie, Centre Hospitalier d'Avignon, Avignon, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}]",American heart journal,['10.1016/j.ahj.2020.04.013']
2995,32473046,"A randomised, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.","BACKGROUND


The risk of invasive pneumococcal disease is significant among solid organ transplant (SOT) recipients. The optimal pneumococcal vaccination strategy for SOT patients is not known.
METHODS


The potential kidney transplant recipients in dialysis were randomised into two arms: to receive a 23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13) before transplantation and a second dose of PCV13 six months after the transplantation. Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, e.g. before and after the second PCV13 (visits V3,V4).
RESULTS


Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study. After the first vaccination , the geometric mean concentrations (GMCs) in the PCV13 arm were significantly higher for 9/13 serotypes and the OPA geometric mean titres (GMTs) were significantly higher for 4/13 serotypes. At V3, the antibody levels had declined but OPA remained significantly higher for 7/13 (PCV13) vs 4/13 (PPV23) serotypes. At V4, the GMCs for 9/13 serotypes and the GMTs for 12/13 serotypes were significantly higher in the PCV13 arm. The GMCs but not GMTs were lower than at V2. There was no difference in adverse effects. No vaccine-related allograft rejection was detected.
CONCLUSIONS


The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .",2020,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","['kidney transplant recipients in dialysis', 'Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study', 'kidney transplant recipients', 'solid organ transplant (SOT) recipients', 'SOT patients']","['23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13', '23-valent pneumococcal polysaccharide vaccination']","['geometric mean concentrations (GMCs', 'allograft rejection', 'immunogenicity of PCV13', 'OPA', 'adverse effects', 'antibody levels', 'OPA geometric mean titres (GMTs', 'Serotype-specific antibody concentrations and opsonophagocytic activity (OPA']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",133.0,0.0617085,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases, Helsinki University Hospital and Helsinki University, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Käyhty', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Saha', 'Affiliation': 'Tampere University Hospital, Division of Nephrology, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Lahdenkari', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Koskinen', 'Affiliation': 'HUH Abdominal Center, Division of Nephrology, Helsinki University Hospital and Helsinki University, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'HUH Abdominal Center, Division of Liver Diseases and Transplantation, Helsinki University Hospital and Helsinki University, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases, Helsinki University Hospital and Helsinki University, Finland.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13343']
2996,31389771,Dealing with Possible Baseline Inequalities Between Experimental Groups - The Case of Motor Learning.,"One important concept of experimental design is the random assignment of participants to experimental groups. This randomization process is used to prevent selection bias, as well as to provide a strong basis for a cause-and-effect relationship between the independent variable/s and the dependent variable/s. In small sample sizes, simple randomization may not provide equal groups at baseline for one or more of the variables, and therefore more restricted types of randomization, such as the stratified permuted-block randomization, can be used. A code was written to calculate the probability that simple randomization will not lead to equality between groups at baseline, and then an example of stratified permuted-block randomization was examined. The findings suggest that for certain variables that are commonly measured in experiments in motor learning, there is a relatively high probability that groups will not be equal at baseline after simple randomization. This observation reflects the small sample sizes usually found in the literature on motor learning. However, stratified permuted-block randomization does lead to greater equality among groups. Implications for researchers are discussed, and a flowchart is proposed that will allow researchers to decide whether to use simple or stratified randomization.",2020,"In small sample sizes, simple randomization may not provide equal groups at baseline for one or more of the variables, and therefore more restricted types of randomization, such as the stratified permuted-block randomization, can be used.",[],[],[],[],[],[],,0.0607563,"In small sample sizes, simple randomization may not provide equal groups at baseline for one or more of the variables, and therefore more restricted types of randomization, such as the stratified permuted-block randomization, can be used.","[{'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Ziv', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Lidor', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Netz', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel.'}]",Journal of motor behavior,['10.1080/00222895.2019.1649996']
2997,29190126,Understanding the Effects of Stigma Messages: Danger Appraisal and Message Judgments.,"Media coverage of health issues has been criticized for creating health stigmas. The model of stigma communication (MSC, Smith, 2007) provides insights into why this is so, but it has two problems: Some of its mediators have not been supported, and it does not do a good job of predicting the transmission of stigma messages (i.e., social transmission). We present a revised model of stigma message effects in which exposure to stigma messages leads to stigma beliefs and stigmatization as a result of a person-oriented danger appraisal. In addition, message judgments-shock value and common ground-are introduced as mediators of the relationship between danger appraisal and social transmission. Participants (N = 200) were randomly assigned to read a health story written either with or without the intrinsic features of stigma messages. The revised model of stigma-message effects was supported: Reading a health news story written with (vs. without) the intrinsic features of stigma messages resulted in greater danger appraisal, which directly predicted stigma-related outcomes and indirectly predicted social transmission through message judgments. Social transmission varied by message judgment: Shocking messages were shared in ways that facilitate diffusion, but common ground messages were shared with influential others, suggesting different means by which stigma as a collective norm may emerge from interactions among community members.",2019,"The revised model of stigma-message effects was supported: Reading a health news story written with (vs. without) the intrinsic features of stigma messages resulted in greater danger appraisal, which directly predicted stigma-related outcomes and indirectly predicted social transmission through message judgments.",['Participants (N\xa0=\xa0200'],['health story written either with or without the intrinsic features of stigma messages'],[],"[{'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",[],200.0,0.030168,"The revised model of stigma-message effects was supported: Reading a health news story written with (vs. without) the intrinsic features of stigma messages resulted in greater danger appraisal, which directly predicted stigma-related outcomes and indirectly predicted social transmission through message judgments.","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'a Department of Communication Arts and Sciences , Pennsylvania State University.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'a Department of Communication Arts and Sciences , Pennsylvania State University.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': 'b Klein College of Media and Communication , Temple University.'}]",Health communication,['10.1080/10410236.2017.1405487']
2998,31341013,Delaying and withholding interventions: ethics and the stepped wedge trial.,"Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: (1) when the study intervention appears especially likely to be effective and (2) when the consequences of not receiving the intervention may be dire. But despite an increase in the use of the stepped wedge design and appeals to its ethical superiority as the motivation for its selection, there has been limited attention to the stepped wedge trial in the ethics literature. In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial. I argue that while the stepped wedge design is ethically permissible, it is not morally superior to other kinds of trials. To this end, I examine the ethical justification for providing, withholding, and delaying interventions in research.",2019,"In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial.",[],[],[],[],[],[],,0.0579128,"In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial.","[{'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Binik', 'Affiliation': 'Department of Philosophy, McMaster University, Hamilton, Ontario, Canada.'}]",Journal of medical ethics,['10.1136/medethics-2018-105138']
2999,31238700,Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke.,"BACKGROUND


In patients with acute minor ischemic stroke or high-risk transient ischemic attack enrolled in the POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke [POINT] Trial), the combination of clopidogrel and aspirin for 90 days reduced major ischemic events but increased major hemorrhage in comparison to aspirin alone.
METHODS


In a secondary analysis of POINT (N=4881), we assessed the time course for benefit and risk from the combination of clopidogrel and aspirin. The primary efficacy outcome was a composite of ischemic stroke, myocardial infarction, or ischemic vascular death. The primary safety outcome was major hemorrhage. Risks and benefits were estimated for delayed times of treatment initiation using left-truncated models.
RESULTS


Through 90 days, the rate of major ischemic events was initially high then decreased markedly, whereas the rate of major hemorrhage remained low but relatively constant throughout. With the use of a model-based approach, the optimal change point for major ischemic events was 21 days (0-21 days hazard ratio 0.65 for clopidogrel-aspirin versus aspirin; 95% CI, 0.50-0.85; P=0.0015, in comparison to 22-90 days hazard ratio, 1.38; 95% CI, 0.81-2.35; P=0.24). Models showed benefits of clopidogrel-aspirin for treatment delayed as long as 3 days after symptom onset.
CONCLUSIONS


The benefit of clopidogrel-aspirin occurs predominantly within the first 21 days, and outweighs the low, but ongoing risk of major hemorrhage. When considered with the results of the CHANCE trial (Clopidogrel in High-Risk Patients With Non-disabling Cerebrovascular Events), a similar trial treating with clopidogrel-aspirin for 21 days and showing no increase in major hemorrhage, these results suggest that limiting clopidogrel-aspirin use to 21 days may maximize benefit and reduce risk after high-risk transient ischemic attack or minor ischemic stroke.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT00991029.",2019,"Through 90 days, the rate of major ischemic events was initially high then decreased markedly, while the rate of major hemorrhage remained low but relatively constant throughout.","['after Acute Transient Ischemic Attack and Minor Ischemic Stroke', 'patients with acute minor ischemic stroke or high-risk transient ischemic attack']","['clopidogrel-aspirin', 'clopidogrel-aspirin vs. aspirin', 'Clopidogrel and Aspirin', 'clopidogrel and aspirin']","['composite of ischemic stroke, myocardial infarction, or ischemic vascular death', 'rate of major ischemic events', 'rate of major hemorrhage', 'major hemorrhage']","[{'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,,"Through 90 days, the rate of major ischemic events was initially high then decreased markedly, while the rate of major hemorrhage remained low but relatively constant throughout.","[{'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).""}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E., Y.Y.P.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E., M.F., A.S.K., K.G.Z.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E., M.F., A.S.K., K.G.Z.).'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B.).'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E., M.F., A.S.K., K.G.Z.).'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, MD (A.S.L.).'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).""}, {'ForeName': 'Karla G', 'Initials': 'KG', 'LastName': 'Zurita', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E., M.F., A.S.K., K.G.Z.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford Stroke Center, Stanford University, Palo Alto, CA (G.W.A., N.V.).'}, {'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Cucchiara', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia (B.L.C.).'}, {'ForeName': 'Dawn O', 'Initials': 'DO', 'LastName': 'Kleindorfer', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, OH (D.O.K.).'}, {'ForeName': 'Helmi L', 'Initials': 'HL', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland (H.L.L.).'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI (C.P.).'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Cone Health Comprehensive Stroke Center/Guilford Neurologic Associates, Greensboro, NC (P.S.).'}, {'ForeName': 'Nirali', 'Initials': 'N', 'LastName': 'Vora', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford Stroke Center, Stanford University, Palo Alto, CA (G.W.A., N.V.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.040713']
3000,31311743,Kegel's exercise to improve sexual self-efficacy in primiparous women.,"OBJECTIVE


Sexuality is one of the crucial aspects of an individual's quality of life. Women, especially primiparous women could have concerns about sexuality which interrupt their sexual self-efficacy in the postpartum period. This study aimed to identify the effect of Kegel's exercise on sexual self-efficacy in primiparous women.
METHOD


This quasi-experimental study with one group time series design involved 32 primiparous women as respondent. Sexual self-efficacy was measured in three times: before intervention, the first three weeks after intervention, and the second three weeks after intervention.
RESULTS


Kegel's exercise for six weeks was associated with significant improvement of the sexual self-efficacy of primiparous women (p=0.001; CI 95% 10.53-14.18).
CONCLUSION


Kegel's exercise increases pelvic floor muscle strength which is linked with the improvement of sexual self-efficacy of primiparous women. The women may encourage to perform Kegel's exercise to address sexual concerns in the postpartum period.",2019,"Women, especially primiparous women could have concerns about sexuality which interrupt their sexual self-efficacy in the postpartum period.","['32 primiparous women as respondent', 'Women, especially primiparous women', 'primiparous women']","[""Kegel's exercise""]","['sexual self-efficacy', 'Sexual self-efficacy']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0148081,"Women, especially primiparous women could have concerns about sexuality which interrupt their sexual self-efficacy in the postpartum period.","[{'ForeName': 'Nolla Lisa', 'Initials': 'NL', 'LastName': 'Lolowang', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Yati', 'Initials': 'Y', 'LastName': 'Afiyanti', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: yatikris@ui.ac.id.'}, {'ForeName': 'Titin', 'Initials': 'T', 'LastName': 'Ungsianik', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.082']
3001,31085424,Minimal but meaningful: Probing the limits of randomly assigned social identities.,"The current studies (total N = 151) experimentally manipulated meaningfulness in novel social groups and measured any resulting ingroup biases. Study 1 showed that even when groups were arbitrary and presumptively meaningless, 5- to 8-year-old children developed equally strong ingroup biases as children in more meaningful groups. Study 2 explored the lengths required to effectively reduce ingroup biases by stressing the arbitrariness of the grouping dimension. Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures. These results suggest that one needs to go to great lengths to counteract children's tendency to imbue newly encountered social groups with rich affiliative meaning.",2019,"Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures.",[],[],[],[],[],[],151.0,0.0113727,"Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Yale University, New Haven, CT 06511, USA. Electronic address: xin.yang@yale.edu.'}, {'ForeName': 'Yarrow', 'Initials': 'Y', 'LastName': 'Dunham', 'Affiliation': 'Department of Psychology, Yale University, New Haven, CT 06511, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.013']
3002,31377788,"Corrigendum to: Kyriakopoulou M, et al. Evaluation of a simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins: a randomized study.",,2019,,[],['simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins'],[],[],"[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0034090', 'cui_str': 'Vein of lung'}]",[],,0.0183249,,[],"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz214']
3003,31388905,"Capsule Commentary on Satre et al., ""Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial"".",,2019,,['Primary Care Patients with HIV'],['Interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],[],,0.0480839,,"[{'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Karan', 'Affiliation': 'Internal Medicine and Preventive Medicine, Loma Linda University Medical School, Loma Linda, USA. lori.karan@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-019-05171-8']
3004,31380764,Development and Evaluation of MOVit: An Exercise-Enabling Interface for Driving a Powered Wheelchair.,"Powered wheelchair users can experience negative health effects from reduced physical activity. If a user could exercise by driving the chair, it might improve fitness. This paper presents the development of MOVit, an exercise-enabling, wheelchair driving interface. The design goal of MOVit was that users cyclically move their arms to drive the chair, thereby providing a light level of exercise while driving. MOVit supports this arm movement with custom mobile arm supports that also serve as the sensors that provide controller inputs. Here, we first quantified how increasing the frequency and amplitude of arm movement increase oxygen consumption and heart rate. Then, we evaluated two novel control methods for driving by moving the arm supports. Participants without impairment ( N = 24 ) were randomized to one of the two methods, or conventional joystick control, and performed driving tests over two days on a simulator and test course. Our results indicate that driving speed and accuracy were significantly lowered with the exercise-enabling methods compared to joystick control (ANOVA, ), but the decreases were small (speed was ~0.1 m/s less and course tracking error ~1 cm greater). These results show, for the first time, the feasibility of exercising while driving a powered wheelchair.",2019,"Our results indicate that driving speed and accuracy were significantly lowered with the exercise-enabling methods compared to joystick control (ANOVA, p < 0.05), but the decreases were small (speed was ∼0.1 m/s less and course tracking error ∼1 cm greater).",['Participants without impairment (N=24'],['MOVit'],"['frequency and amplitude of arm movement increase oxygen consumption and heart rate', 'driving speed and accuracy']","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]",,0.032948,"Our results indicate that driving speed and accuracy were significantly lowered with the exercise-enabling methods compared to joystick control (ANOVA, p < 0.05), but the decreases were small (speed was ∼0.1 m/s less and course tracking error ∼1 cm greater).","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Lobo-Prat', 'Affiliation': ''}, {'ForeName': 'Yinchu', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Moreso', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lew', 'Affiliation': ''}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Sharifrazi', 'Affiliation': ''}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Reinkensmeyer', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2932121']
3005,30688399,The other serelaxin in acute heart failure study: lessons from a pragmatic clinical trial.,,2019,,[],['serelaxin'],[],[],[{'cui': 'C3700393'}],[],,0.0735132,,"[{'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS, USA.'}]",European journal of heart failure,['10.1002/ejhf.1416']
3006,31321526,"Letter to the editor: ""Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial"".",,2020,,['caregivers of cancer patients'],[],[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.102991,,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8553, Japan. kkaji@hiroshima-u.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kako', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8553, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Noto', 'Affiliation': 'Department of Health Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Oosono', 'Affiliation': 'Community Health Nursing, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Community Health Nursing, National Defense Medical College, Tokorozawa, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04995-8']
3007,31608833,Exploring Parents' Message Receipt and Message Enactment of the World's First Integrated Movement Behaviour Guidelines for Children and Youth.,"The Canadian 24-Hour Movement Guidelines for Children and Youth are novel in how they integrate the guideline recommendations for the full continuum of movement behaviours, from sleep to vigorous physical activity. Research suggests that the integrated guidelines strategy is perceived favourably, and this study is the first to compare this strategy to traditional segregated guidelines on its effectiveness to disseminate health information. Specifically, this study explored (1) the influence of the integrated guidelines strategy on parents' message receipt and message enactment to support their child meet the guidelines, and (2) the relationship between message receipt and message enactment in a youth movement behaviour context. In this prospective randomized experiment, parents ( n = 162) were randomized to read integrated, segregated, or control guidelines and complete pre, post, and 2-week follow-up surveys. Repeated-measures ANOVAs revealed significantly higher message enactment outcomes among participants in the integrated guidelines group ( p < .05). Message receipt and enactment outcomes were significantly correlated ( r > .171,  p < .05). These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context. Furthermore, the integrated guidelines strategy may have an advantage in promoting guideline update and should continue to be explored.",2019,These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context.,"['Children and Youth', 'parents ( n =\xa0162']",[],['Message receipt and enactment outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],[],,0.028936,These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context.,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Tennant', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Tremblay', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Faulkner', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Gainforth', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}]",Journal of health communication,['10.1080/10810730.2019.1651429']
3008,31351923,First clinical trial of a MERS coronavirus DNA vaccine.,,2019,,[],['MERS coronavirus DNA vaccine'],[],[],"[{'cui': 'TS-COV19'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}]",[],,0.0560915,,"[{'ForeName': 'In-Kyu', 'Initials': 'IK', 'LastName': 'Yoon', 'Affiliation': 'International Vaccine Institute, Gwanak-gu, Seoul, 08826, South Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Gwanak-gu, Seoul, 08826, South Korea. Electronic address: jerome.kim@ivi.int.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30397-4']
3009,31640486,Facing the risk of upward mobility: Performance-avoidance goals and social class among high-school students.,"Recent research has shown that lower social class students are more likely to endorse performance-avoidance goals (i.e., the fear of performing poorly) than higher-class students, particularly in situations of success. The purpose of the present research is, first, to test the upward mobility process as a moderator of the link between social class and performance-avoidance goal endorsement. The second aim is to document the further impact of this process on academic performance. Two hundred and fifteen high school students ( M   age  = 17.40,  SD  = 0.69) participated in the experiment. Half of them were randomly assigned to a ""mobility salience"" condition where they completed a mobility perception scale; while the other half completed a neutral scale. Then, they answered performance-avoidance goal items and solved mathematics, physics and life and earth sciences exercises. Results indicated that the salience of the mobility process increased the effect of social class on both performance-avoidance goal endorsement and mathematic performance. In addition, performance-avoidance goals appeared to be a mediator of the interaction effect between social class and the salience of the mobility process on mathematics performance. No such findings were obtained for physics and life and earth sciences. Taken together, these results support the idea that the prospect of experiencing mobility may be one of the mechanisms behind the difficulties encountered by lower-class students in an academic context.",2020,Results indicated that the salience of the mobility process increased the effect of social class on both performance-avoidance goal endorsement and mathematic performance.,"['high-school students', 'Two hundred and fifteen high school students ( M age \xa0=\xa017.40,  SD \xa0=\xa00.69) participated in the experiment']",[],['performance-avoidance goal endorsement and mathematic performance'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]",215.0,0.0150037,Results indicated that the salience of the mobility process increased the effect of social class on both performance-avoidance goal endorsement and mathematic performance.,"[{'ForeName': 'Alisée', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'Universite Clermont Auvergne.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Toczek-Capelle', 'Affiliation': 'Universite Clermont Auvergne.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Darnon', 'Affiliation': 'Universite Clermont Auvergne.'}]",The Journal of social psychology,['10.1080/00224545.2019.1681353']
3010,31647695,Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors.,"PURPOSE


Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid.
METHODS


A preliminary study with crossover design was conducted in a convenience sample. Physician-investigators and research staff were randomly assigned to receive case studies. Case studies were assessed for seriousness and attribution, first unassisted and then with the Decision Aid. Participants completed a feedback survey about the Decision Aid. Effectiveness of reporting and attribution are reported as odds ratios (ORs) with 95% CI. Power to detect associations was limited because of a small sample size.
RESULTS


The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4). Most of the 29 participants reported that the Decision Aid was helpful (93%) and improved decision-making time (69%) and confidence in reporting (83%), and that they would use the Decision Aid in practice (83%).
CONCLUSION


The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports. Study of the Decision Aid in a larger sample with analysis stratified by participant role and SAE reporting experience would further assess the tool's impact.",2019,"The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4).",[],[],"['quality of serious AE (SAE', 'decision-making time']",[],[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0601982,"The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4).","[{'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute, Atrium Health Charlotte NC.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Schenkel', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Meredith K', 'Initials': 'MK', 'LastName': 'Chuk', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buchmeier', 'Affiliation': 'Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Perez', 'Affiliation': 'Bristol-Myers Squibb, New York, NY.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hurley', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Levit', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Suanna S', 'Initials': 'SS', 'LastName': 'Bruinooge', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vose', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE.'}]",Journal of oncology practice,['10.1200/JOP.19.00366']
3011,31634766,Cortisol reactivity and situational drug use in cocaine-dependent females.,"In this double-blind study, cocaine-dependent women were administered a pharmacological stressor or placebo prior to two cue-reactivity procedures. The Inventory of Drug Taking Situations is a self-report questionnaire measuring antecedents to relapse and is comprised of three subscales: negative, positive, and temptation situational drug use. It was hypothesized that women with higher IDTS scores would have a greater cortisol response to the cue-reactivity task while receiving yohimbine versus placebo. All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure. Our results may suggest an association between situational and physiological risk factors in this population.",2019,All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure.,['cocaine-dependent females'],"['placebo', 'pharmacological stressor or placebo', 'yohimbine', 'cocaine']","['Cortisol reactivity and situational drug use', 'cortisol response']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]",,0.113887,All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States. Electronic address: campblau@musc.edu.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Galuska', 'Affiliation': 'Psychology Department, College of Charleston, Charleston, SC 29424, United States.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, Charleston, SC 29401, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Sherman', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States.'}]",Psychiatry research,['10.1016/j.psychres.2019.112611']
3012,31402005,"Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial.","BACKGROUND


Previous blinded trials of household water treatment interventions in low-income settings have failed to detect a reduction in child diarrhoea. Technological advances have enabled the development of automated in-line chlorine dosers that can disinfect drinking water without electricity, while also allowing users to continue their typical water collection practices. We aimed to evaluate the effect of installing novel passive chlorination devices at shared water points on child diarrhoea prevalence in low-income, densely populated communities in urban Bangladesh.
METHODS


In this double-blind cluster-randomised controlled trial, 100 shared water points (clusters) in two low-income urban communities in Bangladesh were randomly assigned (1:1) to have their drinking water automatically chlorinated at the point of collection by a solid tablet chlorine doser (intervention group) or to be treated by a visually identical doser that supplied vitamin C (active control group). The trial followed an open cohort design; all children younger than 5 years residing in households accessing enrolled water points were measured every 2-3 months during a 14-month follow-up period (children could migrate into or out of the cluster). The primary outcome was caregiver-reported child diarrhoea (≥3 loose or watery stools in a 24-h period [WHO criteria]) with a 1-week recall, including all available childhood observations in the analyses. This trial is registered with ClinicalTrials.gov, number NCT02606981, and is completed.
FINDINGS


Between July 5, 2015, and Nov 11, 2015, 100 water points with 920 eligible households were enrolled into the study and randomly assigned to the treatment (50 water points; 517 children at baseline; 2073 child observations included in the primary analysis) or control groups (50; 519; 2154). Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91). Drinking water at the point of collection at treatment taps had detectable free chlorine residual 83% (mean 0·37 ppm) of the time compared with 0% at control taps (0·00 ppm).
INTERPRETATION


Passive chlorination at the point of collection could be an effective and scalable strategy in low-income urban settings for reducing child diarrhoea and for achieving global progress towards Sustainable Development Goal 6.1 to attain universal access to safe and affordable drinking water. Targeting a low chlorine residual (<0·5 ppm) in treated water can increase taste acceptability of chlorinated drinking water while still reducing the risk of diarrhoea.
FUNDING


The World Bank.",2019,"Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91).","['children younger than 5 years residing in households accessing enrolled water points', 'Between July 5, 2015, and Nov 11, 2015, 100 water points with 920 eligible households were enrolled into the study and randomly assigned to the treatment (50 water points; 517 children at baseline; 2073 child observations included in the primary analysis) or control groups (50; 519; 2154', '100 shared water points (clusters) in two low-income urban communities in Bangladesh', 'child diarrhoea prevalence in low-income, densely populated communities in urban Bangladesh', 'child diarrhoea in urban Bangladesh']","['line drinking water chlorination', 'installing novel passive chlorination devices', 'drinking water automatically chlorinated at the point of collection by a solid tablet chlorine doser (intervention group) or to be treated by a visually identical doser that supplied vitamin C (active control group']","['risk of diarrhoea', 'caregiver-reported child diarrhoea (≥3 loose or watery stools', 'WHO-defined diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0175961', 'cui_str': 'Chlorination'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",517.0,0.190009,"Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91).","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; Civil and Environmental Engineering, Stanford University, Stanford, CA, USA. Electronic address: amy.pickering@tufts.edu.'}, {'ForeName': 'Yoshika', 'Initials': 'Y', 'LastName': 'Crider', 'Affiliation': 'Civil and Environmental Engineering, Stanford University, Stanford, CA, USA; Energy and Resources Group, University of California Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sultana', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Swarthout', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; Civil and Environmental Engineering, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Frederick Gb', 'Initials': 'FG', 'LastName': 'Goddard', 'Affiliation': 'Civil and Environmental Engineering, Stanford University, Stanford, CA, USA; Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Anjerul Islam', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shreyan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Raga', 'Initials': 'R', 'LastName': 'Ayyagari', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30315-8']
3013,31140141,Will district health centres use preloaded cell phones for pre-referral phone calls for women in labour: a randomized pilot study at Mbarara Regional Referral Hospital in southwest Uganda.,,2019,,"['Mbarara Regional Referral Hospital in southwest Uganda', 'women in labour']",[],[],"[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]",[],[],,0.0266601,,"[{'ForeName': 'Hamson', 'Initials': 'H', 'LastName': 'Kanyesigye', 'Affiliation': 'Department of Obstetrics Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda. kanyehamson@gmail.com.'}, {'ForeName': 'Obed', 'Initials': 'O', 'LastName': 'Muhwezi', 'Affiliation': 'Mbarara Regional Referral Hospital, Mbarara, Uganda.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kazungu', 'Affiliation': 'Mbarara Regional Referral Hospital, Mbarara, Uganda.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kemigisha', 'Affiliation': 'Department of Human Development and Relational Sciences, Faculty of Interdisciplinary Studies, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Woolcott', 'Affiliation': 'Department of Obstetrics and Gynecology and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}]",Canadian journal of public health = Revue canadienne de sante publique,['10.17269/s41997-019-00222-3']
3014,32122618,Electronic cigarettes containing nicotine increase endothelial and platelet derived extracellular vesicles in healthy volunteers.,"BACKGROUND AND AIMS


E-cigarette use is increasingly common. Whether e-cigarettes are harmful to human health is an intensely debated subject. In order to investigate whether e-cigarettes with and without nicotine cause different vascular responses, we obtained blood samples from healthy young volunteers who performed brief active e-cigarette inhalations. Extracellular vesicles (EVs) of endothelial and platelet origin were measured to determine vascular changes.
METHODS


Using a randomized, double-blind, crossover design, 17 healthy occasional smokers inhaled 30 puffs of e-cigarette vapor during 30 min. Blood samples were collected at baseline, as well as at 0, 2, 4 and 6 h post-exposure. EVs from platelets and endothelial cells were measured by flow cytometry.
RESULTS


Platelet and endothelial derived EVs were significantly increased with peak levels seen at 4 h following exposure to active inhalation of e-cigarette vapor with nicotine. Moreover, platelet derived EVs, expressing platelet activation marker P-selectin and the inflammation marker, CD40 ligand, were also significantly increased following inhalation of e-cigarette vapor with nicotine. In addition, platelet derived EVs expressing CD40 ligand was increased after inhalation of e-cigarette vapor without nicotine.
CONCLUSION


As few as 30 puffs of nicotine-containing e-cigarette vapor caused an increase in levels of circulating EVs of endothelial and platelet origin, which may signify underlying vascular changes. Although e-cigarette vapor without nicotine caused an increase in platelet EVs expressing CD40 ligand, nicotine, as a component in the vapor, seems to have a more compelling effect on extracellular vesicle formation and protein composition.",2020,"Although e-cigarette vapor without nicotine caused an increase in platelet EVs expressing CD40 ligand, nicotine, as a component in the vapor, seems to have a more compelling effect on extracellular vesicle formation and protein composition.","['17 healthy occasional smokers inhaled 30 puffs of e-cigarette vapor during 30\xa0min', 'healthy volunteers', 'healthy young volunteers who performed brief active e-cigarette inhalations']","['e-cigarettes with and without nicotine', 'Electronic cigarettes containing nicotine']","['levels of circulating EVs of endothelial and platelet origin', 'Extracellular vesicles (EVs) of endothelial and platelet origin', 'platelets and endothelial cells', 'Blood samples']","[{'cui': 'C0425294', 'cui_str': 'Trivial cigarette smoker (less than one cigarette/day) (finding)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0597635', 'cui_str': 'Vapor (substance)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",17.0,0.0537835,"Although e-cigarette vapor without nicotine caused an increase in platelet EVs expressing CD40 ligand, nicotine, as a component in the vapor, seems to have a more compelling effect on extracellular vesicle formation and protein composition.","[{'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Mobarrez', 'Affiliation': 'Department of Medical Sciences, Uppsala University, 75185, Uppsala, Sweden.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Antoniewicz', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Division of Internal Medicine, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Hedman', 'Affiliation': 'Umeå University, Department of Public Health and Clinical Medicine, Section of Sustainable Health, The OLIN Unit, Umeå, Sweden.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bosson', 'Affiliation': 'Umeå University, Department of Public Health and Clinical Medicine, Division of Medicine/Respiratory Medicine, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lundbäck', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd University Hospital, Stockholm, Sweden. Electronic address: magnus.lundback@sll.se.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.02.010']
3015,32113660,"Re: Robert A. Huddart, Emma Hall, Rebecca Lewis, et al. Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial. Eur Urol 2020;77:260-8.",,2020,,['Patients Treated for Muscle-invasive Bladder Cancer with'],['Radiotherapy ± Chemotherapy'],['Quality of Life Outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[{'cui': 'C0034380'}],,0.109066,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China; Department of Biological Repositories, Zhongnan Hospital of Wuhan University, Wuhan, China. Electronic address: lisheng-znyy@whu.edu.cn.'}]",European urology,['10.1016/j.eururo.2020.02.014']
3016,31853633,Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting.,"INTRODUCTION


The aim of the study was to compare the effectiveness of cognitive behavioural therapy interventions for insomnia (CBT-I) to that of a sleep hygiene intervention in a randomized controlled design among shift workers. We also studied whether the features of shift work disorder (SWD) affected the results.
METHODS


A total of 83 shift workers with insomnia disorder were partially randomized into a group-based CBT-I, self-help CBT-I, or sleep hygiene control intervention. The outcomes were assessed before and after the interventions and at 6-month follow-up using questionnaires, a sleep diary, and actigraphy.
RESULTS


Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time improved after the interventions, but we found no significant differences between the interventions. Mood symptoms improved only among the group-based CBT-I intervention participants. Non-SWD participants had more mental diseases and symptoms, used more sleep-promoting medication, and had pronounced insomnia severity and more dysfunctional beliefs than those with SWD. After the interventions, non-SWD participants showed more prominent improvements than those with SWD.
CONCLUSIONS


Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention. Alleviation of mood symptoms seemed to be the main added value of the group-based CBT-I intervention compared to the control intervention. The clinical condition of the non-SWD participants was more severe and these participants benefitted more from the interventions than the SWD participants did.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02523079.",2020,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"['83 shift workers with insomnia disorder', 'insomnia among shift workers', 'shift workers']","['cognitive behavioural therapy interventions', 'CBT-I, self-help CBT-I, or sleep hygiene control intervention', 'Cognitive behavioural therapy interventions', 'sleep hygiene intervention']","['insomnia severity and more dysfunctional beliefs', 'Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time', 'Mood symptoms', 'sleep diary, and actigraphy']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",83.0,0.0429972,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"[{'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Järnefelt', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland. heli.jarnefelt@ttl.fi.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Härmä', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sallinen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Virkkala', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Kari-Pekka', 'Initials': 'KP', 'LastName': 'Martimo', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Hublin', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}]",International archives of occupational and environmental health,['10.1007/s00420-019-01504-6']
3017,32228328,Not All Green Is Tophi: The Importance of Optimizing Minimum Attenuation and Using a Tin Filter to Minimize Clumpy Artifacts on Foot and Ankle Dual-Energy CT.,"OBJECTIVE.  The clumpy artifact has a high misdiagnosis rate, but the artifact has not been well studied. The aims of this study were to evaluate the frequency and location of clumpy artifacts, the rate of misdiagnosis of clumpy artifacts as gout, and the effects of raising the minimum attenuation value and using a selective photon shield in dual-energy CT (DECT).  MATERIALS AND METHODS.  Forty patients without gout who underwent foot and ankle DECT were enrolled in this study. Images in both sets were randomly assigned a minimum attenuation of 130 HU or 150 HU. Three radiologists independently checked all images for presence, volume, and location of green color-coded pixelation and graded their findings according to a 4-point confidence scale, frequency, and volume. Misdiagnosis rate and misdiagnosis score were compared using the Wilcoxon signed rank and McNemar tests.  RESULTS.  In set 1, the frequency of clumpy artifacts in DECT with the minimum attenuation set to 130 HU and 150 HU were 81% and 68%, respectively. For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU. In set 2, with the minimum attenuation set to 130 HU, the frequency of the clumpy artifact was 44%; with the minimum attenuation set to 150 HU, no clumpy artifacts were seen.  CONCLUSION.  Clumpy artifacts occurred frequently in DECT without a tin filter. Setting the minimum attenuation to the higher value of 150 HU reduced the frequency of clumpy artifacts, and adding a tin filter to DECT greatly reduced their occurrence.",2020,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.",['Forty patients without gout who underwent foot and ankle DECT'],['DECT'],"['Misdiagnosis rate and misdiagnosis score', 'misdiagnosis rate and misdiagnosis score', 'Clumpy artifacts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",[],"[{'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}]",40.0,0.0186423,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.","[{'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Yoo', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'You Seon', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Pusan National University Hospital, Biomedical Research Institute, Pusan, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Byon', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Jongjun', 'Initials': 'J', 'LastName': 'Pak', 'Affiliation': 'Siemens Healthineers Ltd., Diagnostic Imaging Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yunjung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22222']
3018,32250171,The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.,"BACKGROUND


Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations.
AIM


The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older.
METHODS


This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer.
RESULTS


We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals.
CONCLUSIONS


We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.",2020,,[],[],[],[],[],[],,0.0302903,,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Trine L', 'Initials': 'TL', 'LastName': 'Wilkens', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Clement A', 'Initials': 'CA', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Joline Wj', 'Initials': 'JW', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Edenberg', 'Affiliation': 'Indiana University School of Medicine, USA.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Eriksen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Ilse C', 'Initials': 'IC', 'LastName': 'Schrieks', 'Affiliation': 'Department of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': ""Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.""}]",European journal of preventive cardiology,['10.1177/2047487320912376']
3019,32124032,Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty.,"BACKGROUND


Coronal alignment of the tibial component determines functional outcome and survival in total knee arthroplasty (TKA). Innovative techniques for tibial instrumentation have been developed to improve accuracy and reduce the rate of outliers.
METHODS


In a prospective study, 300 patients were allocated to four different groups using a randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI); n = 75 for each group). The aims were to reconstruct the medial proximal tibial angle (MPTA) to 90° and the mechanical tibio-femoral axis (mTFA) to 0°. Both angles were evaluated and compared between all groups three months after the surgery. Patients who presented with a postoperative mTFA > 3° were classified as outliers.
RESULTS


The navigation and intramedullary technique both demonstrated that they were significantly more precise in reconstructing a neutral mTFA and MPTA compared to the other two techniques. The odd's ratio (OR) for producing outliers was highest for the PSI method (PSI OR = 5.5, p < 0.05; extramedullary positioning OR = 3.7, p > 0.05; intramedullary positioning OR = 1.7, p > 0.05; navigation OR = 0.04, p < 0.05). We could only observe significant differences between pre- and postoperative MPTA in the navigation and intramedullary group. The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
CONCLUSION


The navigation and intramedullary instrumentation provided the precise positioning of the tibial component. Outliers were most common within the PSI and extramedullary technique. Optimal alignment is dependent on the technique of tibial instrumentation and tibial component positioning determines the accuracy in TKA since mTFA correlated with MPTA pre- and postoperatively.",2020,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","['Patients who presented with a postoperative mTFA\u2009>\u20093° were classified as outliers', 'total knee arthroplasty (TKA', 'total knee arthroplasty', '300 patients']","['tibial positioning', 'randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI', 'conventional and innovative techniques']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]",[],300.0,0.0211651,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Zahn', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Graef', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany. frank.graef@charite.de.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Conrad', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perka', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hommel', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03389-4']
3020,32115662,Effects of exercise training combined with psychological intervention compared to exercise training alone in prediabetes subjects.,"BACKGROUND


Prior research has confirmed the efficacy of exercise training (ET) in patients with prediabetes. However, whether the effectiveness of a combination of exercise and psychological intervention (EP) is better than ET alone in prediabetes in terms of physiological function, psychological status and glycometabolism has rarely been investigated.
METHODS


Forty newly diagnosed prediabetes patients (65.3 ± 8.1 years) took part in the study. Subjects were divided into a pure ET group and a combined EP group. Interventions were conducted in 40-50-min sessions twice weekly for 32 weeks. Physiological, psychological and biochemical indicator measurements were taken after pre-, mid- and post-interventions, respectively.
RESULTS


The main finding confirmed a significant improvement in systolic blood pressure, diastolic blood pressure (DBP) and heart rate, high-density lipoprotein, fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) from pre- to mid- and post-test differentially in both groups (P < 0.05) by post hoc analyses. The EP group has a greater magnitude of improvement of DBP than the ET group. Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups. Self-Rating Anxiety Scale (SAS) scores of EP group were significantly less than ET group after post-intervention.
CONCLUSION


Our results suggest that EP might be a promising method lead to more apparent long-term effects on glycometabolism and psychological status for prediabetes patients. Other domains were improved by both interventions, but no typical pattern could be identified. Its underlying mechanisms need further study, and directions for future research are suggested.",2020,Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups.,"['prediabetes patients', 'prediabetes subjects', 'patients with prediabetes', 'Forty newly diagnosed prediabetes patients (65.3\xa0±\xa08.1\xa0years) took part in the study']","['exercise training alone', 'exercise and psychological intervention (EP', 'exercise training (ET', 'exercise training combined with psychological intervention']","['Self-Rating Anxiety Scale (SAS) scores', 'Physiological, psychological and biochemical indicator measurements', 'DBP', 'FPG at mid-intervention and total cholesterol', 'systolic blood pressure, diastolic blood pressure (DBP) and heart rate, high-density lipoprotein, fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",40.0,0.017299,Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Siyu', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qun', 'Affiliation': 'Shanghai Dongfang Hospital, Shanghai 200120, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Yibiao', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Wenping', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'She', 'Initials': 'S', 'LastName': 'Qian', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bo', 'Affiliation': 'Shanghai Dongfang Hospital, Shanghai 200120, China.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Xiaonan', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdaa024']
3021,31399377,"Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis.","BACKGROUND


The adjuvanted recombinant zoster vaccine (Shingrix) can prevent herpes zoster in older adults and autologous haemopoietic stem cell transplant recipients. We evaluated the safety and immunogenicity of this vaccine in adults with haematological malignancies receiving immunosuppressive cancer treatments.
METHODS


In this phase 3, randomised, observer-blind, placebo-controlled study, done at 77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants according to their underlying diseases. The co-primary objectives of the study were the evaluation of safety and reactogenicity of the adjuvanted recombinant zoster vaccine compared with placebo from the first vaccination up to 30 days after last vaccination in all participants; evaluation of the proportion of participants with a vaccine response in terms of anti-glycoprotein E humoral immune response to the adjuvanted recombinant zoster vaccine at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia; and evaluation of the anti-glycoprotein E humoral immune responses to the vaccine compared with placebo at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. We assessed immunogenicity in the per-protocol cohort for immunogenicity and safety in the total vaccinated cohort. The study is registered with ClinicalTrials.gov, number NCT01767467, and with the EU Clinical Trials Register, number 2012-003438-18.
FINDINGS


Between March 1, 2013, and Sept 10, 2015, we randomly assigned 286 participants to adjuvanted recombinant zoster vaccine and 283 to placebo. 283 in the vaccine group and 279 in the placebo group were vaccinated. At month 2, 119 (80·4%, 95% CI 73·1-86·5) of 148 participants had a humoral vaccine response to adjuvanted recombinant zoster vaccine, compared with one (0·8%, 0·0-4·2) of 130 participants in the placebo group, and the adjusted geometric mean anti-glycoprotein E antibody concentration was 23 132·9 mIU/mL (95% CI 16 642·8-32 153·9) in the vaccine group and 777·6 mIU/mL (702·8-860·3) in the placebo group (adjusted geometric mean ratio 29·75, 21·09-41·96; p<0·0001) in all patients, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. Humoral and cell-mediated immune responses persisted above baseline until month 13 in all strata and, as expected, vaccine was more reactogenic than placebo (within 7 days after vaccination pain was reported by 221 [79·5%] of 278 vaccine group participants and 45 [16·4%] of 274 placebo group participants; fatigue was reported by 162 [58·3%] of 278 vaccine group participants and 102 [37·2%] of 274 placebo group participants). Incidences of unsolicited or serious adverse events, potential immune-mediated diseases, disease-related events, and fatal serious adverse events were similar between the groups.
INTERPRETATION


The immunocompromised adult population with haematological malignancies is at high risk for herpes zoster. The adjuvanted recombinant zoster vaccine, which is currently licensed in certain countries for adults aged 50 years and older, is likely to benefit this population.
FUNDING


GlaxoSmithKline Biologicals SA.",2019,"Humoral and cell-mediated immune responses persisted above baseline until month 13 in all strata and, as expected, vaccine was more reactogenic than placebo (within 7 days after vaccination pain was reported by 221 [79·5%] of 278 vaccine group participants and 45 [16·4%] of 274 placebo group participants; fatigue was reported by 162 [58·3%] of 278 vaccine group participants and 102 [37·2%] of 274 placebo group participants).","['adults with haematological malignancies', '1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants according to their underlying diseases', 'at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia', 'adults aged 50 years and older', 'number 2012-003438-18.\nFINDINGS\n\n\nBetween March 1, 2013, and Sept 10, 2015, we randomly assigned 286 participants to adjuvanted', 'adults with haematological malignancies receiving immunosuppressive cancer treatments', 'all participants; evaluation of the proportion of participants with a vaccine response in terms of anti-glycoprotein E humoral immune response to the adjuvanted recombinant zoster vaccine at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia', 'all patients, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia', '77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted', 'older adults and autologous haemopoietic stem cell transplant recipients']","['recombinant zoster vaccine or placebo', 'vaccine', 'placebo', 'recombinant zoster vaccine and 283 to placebo', 'recombinant zoster vaccine (Shingrix', 'adjuvanted recombinant zoster vaccine']","['Incidences of unsolicited or serious adverse events, potential immune-mediated diseases, disease-related events, and fatal serious adverse events', 'Immunogenicity and safety', 'safety and reactogenicity', 'safety and immunogenicity', 'Humoral and cell-mediated immune responses', 'adjusted geometric mean anti-glycoprotein E antibody concentration', 'humoral vaccine response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C1155229'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C4530100', 'cui_str': 'Shingrix'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",286.0,0.601071,"Humoral and cell-mediated immune responses persisted above baseline until month 13 in all strata and, as expected, vaccine was more reactogenic than placebo (within 7 days after vaccination pain was reported by 221 [79·5%] of 278 vaccine group participants and 45 [16·4%] of 274 placebo group participants; fatigue was reported by 162 [58·3%] of 278 vaccine group participants and 102 [37·2%] of 274 placebo group participants).","[{'ForeName': 'Alemnew F', 'Initials': 'AF', 'LastName': 'Dagnew', 'Affiliation': 'GSK, Rockville, MD, USA. Electronic address: alemnew.x.dagnew@gsk.com.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Ilhan', 'Affiliation': 'Department of Hematology, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Won-Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Hemato-Oncology, Internal Medicine, Inje University Busan Paik Hospital, Busan, South Korea.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Woszczyk', 'Affiliation': 'Department of Haematology, University of Opole, Provincial Hospital, Opole, Poland.'}, {'ForeName': 'Jae-Yong', 'Initials': 'JY', 'LastName': 'Kwak', 'Affiliation': 'Department of Internal Medicine, Chonbuk National University Medical School and Hospital, Jeonju, South Korea.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Sang Kyun', 'Initials': 'SK', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rodriguez Macías', 'Affiliation': 'Department of Hematology, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Tzeon-Jye', 'Initials': 'TJ', 'LastName': 'Chiou', 'Affiliation': 'Division of Transfusion Medicine, Department of Medicine, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Dimas', 'Initials': 'D', 'LastName': 'Quiel', 'Affiliation': 'Complejo Hospitalario Metropolitano Dr Arnulfo Arias Madrid, Panama City, Panama.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Aoun', 'Affiliation': 'Infectious Diseases Department, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Maria Belen', 'Initials': 'MB', 'LastName': 'Navarro Matilla', 'Affiliation': 'Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': 'Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Milliken', 'Affiliation': 'Department of Haematology, The Kinghorn Cancer Centre, St Vincents Hospital, Darlinghurst, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Department of Haematology, University Hospital Monklands, NHS Lanarkshire, Airdrie, Scotland, UK.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Salaun', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Fauqued', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'Halozyme Therapeutics, San Diego, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Steen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'CureVac, Tübingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30163-X']
3022,30726984,"Can Removing Tar Information From Cigarette Packages Reduce Smokers' Misconceptions About Low-Tar Cigarettes? An Experiment From One of the World's Lowest Tar Yield Markets, South Korea.","INTRODUCTION


Despite regulations that forbid cigarette packages from displaying messages such as ""mild,"" ""low-tar,"" and ""light,"" many smokers still have misperceptions about ""light"" or ""low-tar"" cigarettes. One reason may be that tar amount displays continue to be permitted. This study examines whether removing tar delivery information from packaging reduces consumer misperceptions about ""low-tar"" cigarettes.
METHODS


An online experiment was conducted in South Korea among 531 smokers who were randomly assigned to one of two conditions: with and without tar information on cigarette packages. Participants evaluated which type of cigarette was mildest, least harmful, easiest for nonsmokers to start smoking, and easiest for smokers to quit.
RESULTS


Ten out of 12 chi-square tests showed that people judged the lowest reported tar delivery cigarette to be the mildest (p < .01), least harmful (p < .05), easiest to start (p < .05), and easiest to quit (p < .05)-less so in the ""no-tar"" condition than the ""tar"" condition. A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no-tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001). Regression analyses showed that the ""no-tar"" condition negatively predicted the level of misbeliefs after controlling for demographic and smoking-related variables (B [SE] = -.72 (.12), -.50 (.12), -.48 (.13), respectively, p < .001).
CONCLUSIONS


Banning reported tar deliveries from cigarette packages is likely to reduce smokers' misconceptions about ""low-tar"" cigarettes. When reported tar deliveries are absent, smokers have inconsistent judgments about differently packaged cigarettes.
IMPLICATIONS


When cigarette packages depict lower reported tar number deliveries, participants erroneously perceive them to be less harmful than packages displaying higher tar numbers. These misperceptions of harm may prompt smokers who might otherwise attempt to quit smoking to instead consume cigarettes with lower tar deliveries due to the mistaken belief that they will reduce their risk.",2020,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).",['South Korea among 531 smokers'],[],['delivery cigarette'],"[{'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",531.0,0.0139176,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Paek', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dewhirst', 'Affiliation': 'Department of Marketing and Consumer Studies, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hove', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz016']
3023,31262319,Time-dependent tuning of balance control and aftereffects following optical flow perturbation training in older adults.,"BACKGROUND


Walking balance in older adults is disproportionately susceptible to lateral instability provoked by optical flow perturbations. The prolonged exposure to these perturbations could promote reactive balance control and increased balance confidence in older adults, but this scientific premise has yet to be investigated. This proof of concept study was designed to investigate the propensity for time-dependent tuning of walking balance control and the presence of aftereffects in older adults following a single session of optical flow perturbation training.
METHODS


Thirteen older adults participated in a randomized, crossover design performed on different days that included 10 min of treadmill walking with (experimental session) and without (control session) optical flow perturbations. We used electromyographic recordings of leg muscle activity and 3D motion capture to quantify foot placement kinematics, lateral margin of stability, and antagonist coactivation during normal walking (baseline), early (min 1) and late (min 10) responses to perturbations, and aftereffects immediately following perturbation cessation (post).
RESULTS


At their onset, perturbations elicited 17% wider and 7% shorter steps, higher step width and length variability (+171% and +132%, respectively), larger and more variable margins of stability (MoS), and roughly twice the antagonist leg muscle coactivation (p-values<0.05). Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure. After 10 min of perturbation training and their subsequent cessation, older adults walked with longer and more narrow steps, modest increases in foot placement variability, and roughly half the MoS variability and antagonist lower leg muscle coactivation as they did before training.
CONCLUSIONS


Findings suggest that older adults: (i) respond to the onset of perturbations using generalized anticipatory balance control, (ii) deprioritize that strategy following prolonged exposure to perturbations, and (iii) upon removal of perturbations, exhibit short-term aftereffects that indicate a lessening of anticipatory control, an increase in reactive control, and/or increased balance confidence. We consider this an early, proof-of-concept study into the clinical utility of prolonged exposure to optical flow perturbations as a training tool for corrective motor adjustments relevant to walking balance integrity toward reinforcing task-specific, reactive control and/or improving balance confidence in older adults.
TRIAL REGISTRATION


clinicaltrials.gov ( NCT03341728 ). Registered 14 November 2017.",2019,"Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure.","['Thirteen older adults', 'older adults']","['optical flow perturbation training', 'treadmill walking with (experimental session) and without (control session) optical flow perturbations']","['step width and length variability', 'variable margins of stability (MoS), and roughly twice the antagonist leg muscle coactivation', 'leg muscle activity and 3D motion capture to quantify foot placement kinematics, lateral margin of stability, and antagonist coactivation during normal walking (baseline), early (min 1) and late (min 10) responses to perturbations, and aftereffects', 'foot placement variability, and roughly half the MoS variability and antagonist lower leg muscle coactivation', 'balance confidence']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",13.0,0.0428492,"Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure.","[{'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Richards', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Selgrade', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Qiao', 'Affiliation': 'Department of Kinesiology, Louisiana Tech University, Ruston, LA, USA.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Franz', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA. jrfranz@email.unc.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0555-3']
3024,31365801,Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.,"BACKGROUND


Data regarding the efficacy of treatment with ibrutinib-rituximab, as compared with standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab, in patients with previously untreated chronic lymphocytic leukemia (CLL) have been limited.
METHODS


In a phase 3 trial, we randomly assigned (in a 2:1 ratio) patients 70 years of age or younger with previously untreated CLL to receive either ibrutinib and rituximab for six cycles (after a single cycle of ibrutinib alone), followed by ibrutinib until disease progression, or six cycles of chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab. The primary end point was progression-free survival, and overall survival was a secondary end point. We report the results of a planned interim analysis.
RESULTS


A total of 529 patients underwent randomization (354 patients to the ibrutinib-rituximab group, and 175 to the chemoimmunotherapy group). At a median follow-up of 33.6 months, the results of the analysis of progression-free survival favored ibrutinib-rituximab over chemoimmunotherapy (89.4% vs. 72.9% at 3 years; hazard ratio for progression or death, 0.35; 95% confidence interval [CI], 0.22 to 0.56; P<0.001), and the results met the protocol-defined efficacy threshold for the interim analysis. The results of the analysis of overall survival also favored ibrutinib-rituximab over chemoimmunotherapy (98.8% vs. 91.5% at 3 years; hazard ratio for death, 0.17; 95% CI, 0.05 to 0.54; P<0.001). In a subgroup analysis involving patients without immunoglobulin heavy-chain variable region ( IGHV ) mutation, ibrutinib-rituximab resulted in better progression-free survival than chemoimmunotherapy (90.7% vs. 62.5% at 3 years; hazard ratio for progression or death, 0.26; 95% CI, 0.14 to 0.50). The 3-year progression-free survival among patients with  IGHV  mutation was 87.7% in the ibrutinib-rituximab group and 88.0% in the chemoimmunotherapy group (hazard ratio for progression or death, 0.44; 95% CI, 0.14 to 1.36). The incidence of adverse events of grade 3 or higher (regardless of attribution) was similar in the two groups (in 282 of 352 patients [80.1%] who received ibrutinib-rituximab and in 126 of 158 [79.7%] who received chemoimmunotherapy), whereas infectious complications of grade 3 or higher were less common with ibrutinib-rituximab than with chemoimmunotherapy (in 37 patients [10.5%] vs. 32 [20.3%], P<0.001).
CONCLUSIONS


The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL. (Funded by the National Cancer Institute and Pharmacyclics; E1912 ClinicalTrials.gov number, NCT02048813.).",2019,The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL.,"['patients 70 years of age or younger with previously untreated CLL to receive either', 'Chronic Lymphocytic Leukemia', 'patients 70 years of age or younger with previously untreated CLL', '529 patients underwent randomization (354 patients to the ibrutinib-rituximab group, and 175 to the chemoimmunotherapy group', 'patients with previously untreated chronic lymphocytic leukemia (CLL']","['chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab', 'standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab', 'chemoimmunotherapy', 'ibrutinib-rituximab', 'Ibrutinib-Rituximab or Chemoimmunotherapy', 'ibrutinib and rituximab']","['progression-free survival, and overall survival', 'overall survival', 'incidence of adverse events of grade 3 or higher (regardless of attribution', 'progression-free survival', '3-year progression-free survival', 'infectious complications of grade 3 or higher', 'progression-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",529.0,0.352206,The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL.,"[{'ForeName': 'Tait D', 'Initials': 'TD', 'LastName': 'Shanafelt', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Xin V', 'Initials': 'XV', 'LastName': 'Wang', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Kay', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Curtis A', 'Initials': 'CA', 'LastName': 'Hanson', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Barrientos', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Diane F', 'Initials': 'DF', 'LastName': 'Jelinek', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Braggio', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Jose F', 'Initials': 'JF', 'LastName': 'Leis', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Cong C', 'Initials': 'CC', 'LastName': 'Zhang', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Cashen', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Mato', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Mullane', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Erba', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litzow', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tallman', 'Affiliation': 'From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Institute, Boston (X.V.W., R.M.S.); Mayo Clinic, Rochester (N.E.K., C.A.H., J.F.L., M.L.), and Minnesota Oncology, Burnsville (A.K.S.) - both in Minnesota; Northwell Health Cancer Institute, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Lake Success (J.B.), and University of Rochester, Rochester (P.M.B.) - both in New York; Mayo Clinic, Phoenix, AZ (D.F.J., E.B.); Washington University School of Medicine, St. Louis (A.F.C.); Memorial Sloan Kettering Cancer Center, New York (A.R.M., M.T.); Aurora Cancer Care, West Allis, WI (M.P.M.); National Cancer Institute, Bethesda, MD (R.F.L.); and the University of Alabama, Tuscaloosa (H.E.).'}]",The New England journal of medicine,['10.1056/NEJMoa1817073']
3025,22301679,A randomized controlled trial of a cognitive rehabilitation intervention for persons with multiple sclerosis.,"OBJECTIVE


To explore the feasibility and effects of a computer-assisted cognitive rehabilitation intervention - Memory, Attention, and Problem Solving Skills for Persons with Multiple Sclerosis (MAPSS-MS) - for persons with multiple sclerosis on cognitive performance, memory strategy use, self-efficacy for control of symptoms and neuropsychological competence in activities of daily living (ADL).
DESIGN


A randomized controlled single-blinded trial with treatment and wait list control groups.
SETTING


Southwestern United States.
SUBJECTS


Convenience sample of 61 persons (34 treatment, 27 wait list control) with multiple sclerosis (mean age 47.9 years, SD 8.8).
INTERVENTION


The eight-week MAPSS-MS intervention program included two components: (a) eight weekly group sessions focused on building efficacy for use of cognitive compensatory strategies and (b) a computer-assisted cognitive rehabilitation program with home-based training.
OUTCOME MEASURES


A neuropsychological battery of performance tests comprising the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) and self-report instruments (use of memory strategies, self-efficacy for control of multiple sclerosis and neuropsychological competence in ADL) were completed at baseline, two months (after classes), and at five months.
RESULTS


Both groups improved significantly (P < 0.05) over time on most measures in the MACFIMS battery as well as the measures of strategy use and neuropsychological competence in ADL. There was a significant group-by-time interaction for scores on the measures of verbal memory and the use of compensatory strategies.
CONCLUSIONS


The MAPSS-MS intervention was feasible and well-accepted by participants. Given the large relative increase in use of compensatory strategies by the intervention group, it holds promise for enhancing cognitive function in persons with multiple sclerosis.",2012,"There was a significant group-by-time interaction for scores on the measures of verbal memory and the use of compensatory strategies.
","['Convenience sample of 61 persons (34 treatment, 27 wait list control) with multiple sclerosis (mean age 47.9 years, SD 8.8', 'Southwestern United States', 'Persons with Multiple Sclerosis (MAPSS-MS) - for persons with multiple sclerosis', 'persons with multiple sclerosis']","['MAPSS-MS intervention', 'cognitive compensatory strategies and (b) a computer-assisted cognitive rehabilitation program with home-based training', 'computer-assisted cognitive rehabilitation intervention - Memory, Attention, and Problem Solving Skills', 'cognitive rehabilitation intervention']",['strategy use and neuropsychological competence in ADL'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",61.0,0.0254041,"There was a significant group-by-time interaction for scores on the measures of verbal memory and the use of compensatory strategies.
","[{'ForeName': 'Alexa K', 'Initials': 'AK', 'LastName': 'Stuifbergen', 'Affiliation': 'School of Nursing, The University of Texas at Austin, School of Nursing, TX 78701, USA. astulfbergen@mail.utexas.edu'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Morison', 'Affiliation': ''}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Kullberg', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Todd', 'Affiliation': ''}]",Clinical rehabilitation,['10.1177/0269215511434997']
3026,32125709,Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy.,"BACKGROUND


Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular disease with a broad spectrum of disease severity. HCM ranges from a benign course to a progressive disorder characterized by angina, heart failure, malignant arrhythmia, syncope, or sudden cardiac death. So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms. While the angiotensin receptor neprilysin inhibitor sacubitril/valsartan has shown to reduce mortality and hospitalization in heart failure with reduced ejection fraction, data on its effect on HCM are sparse.
HYPOTHESIS


A 4-month pharmacological (sacubitril/valsartan) or lifestyle intervention will significantly improve exercise tolerance (ie, peak oxygen consumption) in patients with nonobstructive HCM compared to the optimal standard therapy (control group).
METHODS


SILICOFCM is a prospective, multicenter, open-label, randomized, controlled, three-arm clinical trial (NCT03832660) that will recruit 240 adult patients with a confirmed diagnosis of nonobstructive HCM. Eligible patients are randomized to sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group). The primary endpoint is the change in functional capacity (ie, peak oxygen consumption). Secondary endpoints include: (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life.
RESULTS


Until December 2019, a total of 41 patients were recruited into the ongoing SILICOFCM study and were allocated to the study groups and the control group. There was no significant difference in key baseline characteristics between the three groups.
CONCLUSION


The SILICOFCM study will provide novel evidence about the effect of sacubitril/valsartan or lifestyle intervention on functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life in patients with nonobstructive HCM.",2020,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","['patients with hypertrophic cardiomyopathy', 'patients with nonobstructive HCM', '41 patients were recruited into the ongoing SILICOFCM study', '240 adult patients with a confirmed diagnosis of nonobstructive HCM', 'Until December 2019', 'Eligible patients', 'patients with nonobstructive HCM compared to the optimal standard therapy (control group']","['pharmacological (sacubitril/valsartan) or lifestyle intervention', 'sacubitril/valsartan vs lifestyle intervention', 'sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group', 'sacubitril/valsartan or lifestyle intervention']","['exercise tolerance (ie, peak oxygen consumption', 'change in functional capacity (ie, peak oxygen consumption', 'functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life', ' (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life', 'functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]",240.0,0.0563467,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tafelmeier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baessler', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Unsoeld', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Preveden', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Barlocco', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tomberli', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Dejana', 'Initials': 'D', 'LastName': 'Popovic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'MacGowan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ristic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Velicki', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Djordje G', 'Initials': 'DG', 'LastName': 'Jakovljevic', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}]",Clinical cardiology,['10.1002/clc.23346']
3027,32065006,Tetrahydrocannabinol and cannabidiol oromucosal spray in resistant multiple sclerosis spasticity: consistency of response across subgroups from the SAVANT randomized clinical trial.,"Objective:  To determine whether differences in disability status, spasticity severity, and spasticity duration at treatment start in patients with resistant multiple sclerosis (MS) spasticity might influence response to add-on tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (nabiximols) versus further re-adjustment of optimized first-line antispasticity medication. Methods:  Using the database from the Sativex ®  as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) study, this post hoc analysis evaluated spasticity severity (0-10 numerical rating scale [NRS] scores) and pain severity (0-10 NRS scores) evolution from randomization (baseline) to week 12 (end of double-blind treatment) in defined subgroups: Expanded disability status scale [EDSS] score subgroups (<6 and ≥6); spasticity severity 0-10 NRS score subgroups (4 to ≤6 and >6), and spasticity duration subgroups (<5 and ≥5 years). Results:  THC:CBD oromucosal spray (nabiximols) halved mean severity scores for spasticity and pain in all subgroups. Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups. Active treatment significantly improved mean pain severity scores versus placebo in the ≥6 EDSS subgroup, in the severe spasticity subgroup and in both spasticity duration subgroups. Conclusion:  Add-on THC:CBD oromucosal spray (nabiximols) consistently relieves resistant spasticity across subgroups defined by baseline EDSS score, spasticity severity NRS score and spasticity duration. Patients with moderate resistant MS spasticity benefit numerically from treatment; patients with severe resistant spasticity achieve significant therapeutic gains. Spasticity-associated pain often improves similarly in the same subgroups.",2020,"Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups.","['patients with resistant multiple sclerosis (MS) spasticity', 'subgroups (< 6 and ≥6); spasticity severity 0-10 NRS score subgroups (4 to ≤6 and >6), and spasticity duration subgroups (< 5 and ≥5 years']","['placebo', 'Tetrahydrocannabinol and cannabidiol oromucosal spray', 'THC:CBD oromucosal spray (nabiximols', 'tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (nabiximols']","['Spasticity-associated pain', 'mean pain severity scores', 'mean spasticity severity scores', 'Disability Status Scale [EDSS] score', 'disability status, spasticity severity, and spasticity duration', 'spasticity severity (0-10 Numerical Rating Scale [NRS] scores) and pain severity (0-10 NRS scores) evolution from randomization (baseline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}, {'cui': 'C2347556', 'cui_str': 'tetrahydrocannabinol-cannabidiol combination'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.065772,"Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups.","[{'ForeName': 'Sven G', 'Initials': 'SG', 'LastName': 'Meuth', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Munster, Munster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Henze', 'Affiliation': 'Praxis Für Neurologie, Regensburg, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Essner', 'Affiliation': 'O. Meany Consultancy GmbH, Hamburg, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Trompke', 'Affiliation': 'R&D, Almirall Hermal GmbH, Reinbek, Germany.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vila Silván', 'Affiliation': 'Global Medical Affairs, Almirall S.A, Barcelona, Spain.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1730832']
3028,31000320,Efficacy of preoperative amino acid supplements on postoperative physical function and complications in open heart surgery patients: A study protocol for a randomized controlled trial.,"BACKGROUND


Elderly patients undergoing cardiac surgery often show poor nutritional status, muscle wasting, and sarcopenia, which are reported to affect postoperative functional recovery and incidence of complications. Amino acids are essential in maintaining nutritional status, synthesizing muscle protein, and promoting beneficial energy balance of the heart muscle. β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases. However, the efficacy of amino acid administration comprising HMB in patients undergoing open heart surgery remains unclear. This study aims to examine whether preoperative short-term aggressive amino acid administration helps support postoperative recovery of physical function and prevent complications.
METHODS


This is a single-center prospective randomized controlled trial (UMIN000030490). Patients aged ≥65 years who will be hospitalized for medical examination before cardiac surgery will be recruited. The participants will be randomly assigned to the experimental or control group. The experimental group will be administered with an amino acid supplement with HMB 1200mg, l-glutamine 7000mg, and l-arginine 7000mg once or twice per day depending on the degree of renal dysfunction, for 14-28 days preoperatively. The control group will not receive any nutritional intervention. The main outcome will be a change in the 6-min walking test distance pre- and postoperatively as a sign of functional recovery. Secondary outcomes such as the incidence of complications; physical, nutritional, and psychological states; mortality; and length of hospital stay will also be evaluated.
CONCLUSION


This clinical study will determine the effects of preoperative short-term oral amino acid supplementation with HMB, l-glutamine, and l-arginine on postoperative physical function in elderly patients undergoing cardiac surgery.",2019,β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases.,"['Patients aged ≥65 years who will be hospitalized for medical examination before cardiac surgery will be recruited', 'patients with muscle wasting due to wearing diseases', 'open heart surgery patients', 'elderly patients undergoing cardiac surgery', 'patients undergoing open heart surgery', 'Elderly patients undergoing cardiac surgery']","['amino acid supplement with HMB 1200mg, l-glutamine 7000mg, and l-arginine', 'amino acid administration comprising HMB', 'preoperative short-term oral amino acid supplementation with HMB, l-glutamine, and l-arginine', 'preoperative amino acid supplements', 'β-Hydroxy β-methylbutyric acid (HMB']","['incidence of complications; physical, nutritional, and psychological states; mortality; and length of hospital stay will also be evaluated', '6-min walking test distance pre- and postoperatively as a sign of functional recovery', 'postoperative physical function and complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0856558', 'cui_str': 'Muscle wasting (disuse)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C4708914', 'cui_str': 'Seven thousand'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0808732,β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ogawa', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan; Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Seimi', 'Initials': 'S', 'LastName': 'Satomi-Kobayashi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. Electronic address: seimik@med.kobe-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kodai', 'Initials': 'K', 'LastName': 'Komaki', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Wakida', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Gotake', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshitada', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazuhiro P', 'Initials': 'KP', 'LastName': 'Izawa', 'Affiliation': 'Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan; Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan; Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Hirata', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.03.011']
3029,31800998,Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins.,,2019,,[],[],[],[],[],[],,0.0631697,,"[{'ForeName': 'Ayad', 'Initials': 'A', 'LastName': 'Jindeel', 'Affiliation': 'Essentia Health, Duluth, MN aj1med@aol.com.'}]",The New England journal of medicine,['10.1056/NEJMc1914045']
3030,31902151,Response: Comparison of the Efficacy of Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy on Lipid Parameters in Patients with Type 2 Diabetes Mellitus ( Diabetes Metab J  2019;43:582-9).,,2019,,['Patients with Type 2 Diabetes Mellitus ( Diabetes Metab J  2019;43:582-9'],['Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy'],['Lipid Parameters'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.01175,,"[{'ForeName': 'You Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea. khmcilyong@khnmc.or.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0213']
3031,31925600,Effectiveness of Housing First for Homeless Adults with Mental Illness Who Frequently Use Emergency Departments in a Multisite Randomized Controlled Trial.,"Frequent emergency department (ED) users experiencing homelessness are associated with high costs for healthcare systems yet interventions for this group have been minimally investigated. This study used 24-month data from a multisite randomized controlled trial of Housing First (HF) to examine how effective the intervention is in helping frequent ED users with a mental illness to achieve housing stability, improve behavioural health and functioning, and reduce their ED use. Findings showed that HF is effective in stably housing frequent ED users despite their complex health needs. Reductions in ED use and substance use problems, and improvements in mental health symptoms and community functioning were found for frequent ED users in both the HF and treatment as usual conditions.",2020,"Reductions in ED use and substance use problems, and improvements in mental health symptoms and community functioning were found for frequent ED users in both the HF and treatment as usual conditions.",['Homeless Adults with Mental Illness'],"['Housing First (HF', 'HF']",['mental health symptoms and community functioning'],"[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",,0.152094,"Reductions in ED use and substance use problems, and improvements in mental health symptoms and community functioning were found for frequent ED users in both the HF and treatment as usual conditions.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Kerman', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Canada. tim.aubry@uottawa.ca.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Adair', 'Affiliation': 'Departments of Psychiatry and Community Health Sciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': 'Department of Geography, University of Winnipeg, Winnipeg, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Latimer', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry, Simon Fraser University, Burnaby, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Canada.'}]",Administration and policy in mental health,['10.1007/s10488-020-01008-3']
3032,29236529,"The Effects of Varying Electronic Cigarette Warning Label Design Features On Attention, Recall, and Product Perceptions Among Young Adults.","This study was a 3 (Brand: Blu, MarkTen, Vuse) by 3 (Warning Size: 20%, 30%, or 50% of advertisement surface) by 2 (Warning Background: White, Red) experimental investigation of the effects of electronic cigarette (e-cigarette) warning label design features. Young adults aged 18-30 years (n = 544) were recruited online, completed demographic and tobacco use history measures, and randomized to view e-cigarette advertisements with warning labels that varied by the experimental conditions. Participants completed a task assessing self-reported visual attention to advertisements with a-priori regions of interest defined around warning labels. Warning message recall and perceived addictiveness of e-cigarettes were assessed post-exposure. Approximately half of participants reported attending to warning labels and reported attention was greater for warnings on red versus white backgrounds. Recall of the warning message content was also greater among those reporting attention to the warning label. Overall, those who viewed warnings on red backgrounds reported lower perceived addictiveness than those who viewed warnings on white backgrounds, and e-cigarette users reported lower perceived addictiveness than non-users. Among e-cigarette users, viewing warnings on white backgrounds produced perceptions more similar to non-users. Greater recall was significantly correlated with greater perceived addictiveness. This study provides some of the first evidence that e-cigarette warning label design features including size and coloring affect self-reported attention and content recall.",2019,"Overall, those who viewed warnings on red backgrounds reported lower perceived addictiveness than those who viewed warnings on white backgrounds, and e-cigarette users reported lower perceived addictiveness than non-users.","['Young Adults', 'Young adults aged 18-30\xa0years (n\xa0=\xa0544']","['task assessing self-reported visual attention to advertisements with a-priori regions of interest defined around warning labels', 'Varying Electronic Cigarette Warning Label Design Features']","['Greater recall', 'Warning message recall and perceived addictiveness of e-cigarettes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]",544.0,0.032503,"Overall, those who viewed warnings on red backgrounds reported lower perceived addictiveness than those who viewed warnings on white backgrounds, and e-cigarette users reported lower perceived addictiveness than non-users.","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'a Department of Oncology Georgetown University Medical Center , Cancer Prevention & Control Program Lombardi Comprehensive Cancer Center.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Villanti', 'Affiliation': 'b Vermont Center on Behavior and Health, Department of Psychiatry , University of Vermont.'}, {'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Niaura', 'Affiliation': 'a Department of Oncology Georgetown University Medical Center , Cancer Prevention & Control Program Lombardi Comprehensive Cancer Center.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Lindblom', 'Affiliation': ""e O'Neill Institute for National and Global Health Law , Georgetown University Law Center.""}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'f Department of Psychiatry, Perelman School of Medicine , University of Pennsylvania.'}]",Health communication,['10.1080/10410236.2017.1372050']
3033,31399794,Comparison of Training Efficacy Between Custom-Made Skills Simulator (CMSS) and da Vinci Skills Simulators: A Randomized Control Study.,"BACKGROUND


To compare the effectiveness of a custom-made skills simulator (CMSS) with the commercially available da Vinci ®  skills simulator (DVSS) that help improving surgical skills for effective and safe robotic surgical interventions.
METHODS


A randomized control study was conducted to determine the performance of participants after undergoing robotic surgical training. Total 64 students who had no previous experience with robotic surgery enrolled this study. After 5 min-introduction of robotic surgical system, the participants got random-assignment into two groups to perform either CMSS-or DVSS-exercises. After 15 min-practicing the corresponding simulator, task-execution performance and individual questionnaires were compared between participants trained with the CMSS and those trained with the DVSS.
RESULTS


Regardless of simulator the participants used, the system understanding and manipulation ability of the participants was found to be higher than after completing the simulation-based robotic surgical training (p < 0.05). However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
CONCLUSIONS


The training effectiveness of CMSS was not significantly different to DVSS. It can be synergetic tool to DVSS for novice trainees of robotic surgery to get accustomed to the robotic surgical system and to improve their basic robotic surgical skills.",2019,"However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
",['Total 64 students who had no previous experience with robotic surgery enrolled this study'],"['CMSS-or DVSS-exercises', 'CMSS', 'robotic surgical training', 'Custom-Made Skills Simulator (CMSS) and da Vinci Skills Simulators', 'custom-made skills simulator (CMSS) with the commercially available da Vinci ®  skills simulator (DVSS']","['required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.0229294,"However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
","[{'ForeName': 'Cho Rok', 'Initials': 'CR', 'LastName': 'Lee', 'Affiliation': 'Department of Thyroid and Endocrine Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Seoung Yoon', 'Initials': 'SY', 'LastName': 'Rho', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Sang Hyup', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': ""Department of Surgery, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Chang Moo', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea. cmkang@yuhs.ac.'}]",World journal of surgery,['10.1007/s00268-019-05108-6']
3034,31350681,The use of mobile technology and peer navigation to promote adolescent and young adult (AYA) cancer survivorship care: results of a randomized controlled trial.,"PURPOSE


Adolescent and young adult (AYA) cancer survivors experience unique barriers that compromise receipt of survivorship care; therefore, development of innovative educational interventions to improve rates of AYA survivorship care is needed. The efficacy of text-messaging and peer navigation interventions was compared to standard-of-care survivorship educational materials to increase AYAs' (1) late effects knowledge and (2) knowledge, attitudes, and self-efficacy towards seeking survivor-focused care.
METHODS


This was a three-armed, prospective, randomized controlled trial with one control group and two intervention groups. The control group received current standard-of-care educational materials. One intervention group participated in a text-messaging program, and the second participated in a peer navigator program. Participants completed pre- and post-intervention questionnaires. Study outcome variables were quantified using Fisher exact tests, two-sample t tests, exact McNemar tests, conditional logistic regression models, and analysis of covariance.
RESULTS


Seventy-one survivors completed the study (control n = 24; text-messaging n = 23; peer navigation n = 24). Late effects knowledge was high at baseline for all groups. The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05. Both intervention groups showed increased attitudes towards seeking survivor-focused care compared to the control group (text-messaging p < 0.05; peer navigation p < 0.05).
CONCLUSIONS


Each intervention demonstrated significant benefits compared to the control group.
IMPLICATIONS FOR CANCER SURVIVORS


Given the preliminary effectiveness of both interventions, each can potentially be used in the future by AYA cancer survivors to educate and empower them to obtain needed survivorship care.",2019,The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05.,"['FOR CANCER SURVIVORS', 'Adolescent and young adult (AYA) cancer survivors', 'adolescent and young adult (AYA) cancer survivorship care']","['mobile technology and peer navigation', 'current standard-of-care educational materials', 'text-messaging and peer navigation interventions', 'text-messaging program, and the second participated in a peer navigator program']","['survivorship care knowledge', 'attitudes towards seeking survivor-focused care', ' (1) late effects knowledge and (2) knowledge, attitudes, and self-efficacy', 'survivorship care self-efficacy']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0038955'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0038955'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",71.0,0.0304395,The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05.,"[{'ForeName': 'Jacqueline N', 'Initials': 'JN', 'LastName': 'Casillas', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, UCLA David Geffen School of Medicine, 10833 Le Conte Avenue, A2-410 MDCC, Los Angeles, CA, 90095-1752, USA. jcasillas@mednet.ucla.edu.'}, {'ForeName': 'Lindsay F', 'Initials': 'LF', 'LastName': 'Schwartz', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, UCLA David Geffen School of Medicine, 10833 Le Conte Avenue, A2-410 MDCC, Los Angeles, CA, 90095-1752, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Crespi', 'Affiliation': 'Department of Biostatistics, UCLA Fielding School of Public Health, Los Angeles, CA, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ganz', 'Affiliation': 'Center for Cancer Prevention and Control Research, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Stuber', 'Affiliation': 'Department of Psychiatry, Resnick Neuropsychiatric Hospital, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Bastani', 'Affiliation': 'Center for Cancer Prevention and Control Research, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alquaddomi', 'Affiliation': 'Department of Computer Science, Cornell University, New York, NY, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Estrin', 'Affiliation': 'Department of Computer Science, Cornell University, New York, NY, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00777-7']
3035,30661523,"Fear and Humor Appeals in ""The Real Cost"" Campaign: Evidence of Potential Effectiveness in Message Pretesting.","INTRODUCTION


In tobacco prevention campaigns, fear-appeal messages are widely used and generally shown to be effective, whereas the utility of humor appeals is less clear. This study compares the potential effectiveness of fear and humor ads developed for ""The Real Cost"" campaign.
METHODS


Adolescents (N=1,315) aged 13-17 years who were either experimenting with smoking or susceptible to smoking initiation were randomized to view either a single ad (of three fear and two humor ads in total) or nothing (control condition). Those in the ad viewing condition completed measures on fear, amusement, and perceived ad effectiveness. All participants completed measures on smoking attitudes and risk perceptions. Data were collected in 2014 and 2015. Analysis was performed in 2016.
RESULTS


Compared with control, both fear and humor ads produced greater risk perceptions (p<0.001). Fear ads also produced more negative smoking attitudes (p=0.001); humor ads had a similar effect on attitudes that approached significance (p=0.07). Fear ads scored higher on perceived ad effectiveness and fear, and lower on amusement than humor ads (p<0.001). In regression models, fear was a stronger predictor of perceived ad effectiveness, smoking attitudes, and risk perceptions than amusement for fear ads, whereas amusement was a stronger predictor of these outcomes than fear for humor ads.
CONCLUSIONS


Both fear and humor appeals have potential to be effective in ""The Real Cost"" campaign. Concurrent employment of these message strategies should help to diversify messaging and consistently recapture the target audience's attention.
SUPPLEMENT INFORMATION


This article is part of a supplement entitled Fifth Anniversary Retrospective of ""The Real Cost,"" the Food and Drug Administration's Historic Youth Smoking Prevention Media Campaign, which is sponsored by the U.S. Food and Drug Administration.",2019,Fear ads also produced more negative smoking attitudes (p=0.001); humor ads had a similar effect on attitudes that approached significance (p=0.07).,"['Adolescents (N=1,315) aged 13-17 years who were either experimenting with smoking or susceptible to smoking initiation']",['single ad (of three fear and two humor ads in total) or nothing (control condition'],"['smoking attitudes and risk perceptions', 'fear, amusement, and perceived ad effectiveness', 'perceived ad effectiveness, smoking attitudes, and risk perceptions', 'negative smoking attitudes', 'risk perceptions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020168', 'cui_str': 'Humor'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0163024,Fear ads also produced more negative smoking attitudes (p=0.001); humor ads had a similar effect on attitudes that approached significance (p=0.07).,"[{'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Office of Health Communication and Education, Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland; Department of Communication, George Mason University, Fairfax, Virginia. Electronic address: xzhao3@gmu.edu.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Roditis', 'Affiliation': 'Office of Health Communication and Education, Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tesfa N', 'Initials': 'TN', 'LastName': 'Alexander', 'Affiliation': 'Public Health Research and Translational Science, Battelle Memorial Institute, Baltimore, Maryland.'}]",American journal of preventive medicine,['10.1016/j.amepre.2018.07.033']
3036,31764095,HIV-1 genetic diversity to estimate time of infection and infer adherence to preexposure prophylaxis.,"OBJECTIVE


To estimate time of HIV infection in participants from the Bangkok Tenofovir Study (BTS) with daily oral tenofovir disoproxil fumarate (TDF) for preexposure prophylaxis (PrEP) and relate infection with adherence patterns.
DESIGN


We used the diversity structure of the virus population at the first HIV RNA-positive sample to estimate the date of infection, and mapped these estimates to medication diaries obtained under daily directly observed therapy (DOT).
METHODS


HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients. We generated 10-25 HIV env sequences from each participant by single genome amplification, and calculated time since infection (and 95% confidence interval) using Poisson models of early virus evolution. Study medication diaries obtained under daily DOT were then used to compute the number of missed TDF doses at the approximate date of infection.
RESULTS


Fifteen of the 17 PrEP breakthrough infections were successfully amplified. Of these, 13 were initiated by a single genetic variant and generated reliable estimates of time since infection (median = 47 [IQR = 35] days). Eleven of these 13 were under daily DOT at the estimated time of infection. Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
CONCLUSION


We estimated time of infection in participants from BTS and found several infections when high levels of adherence to TDF were reported. Our results suggest that the biological efficacy of daily TDF against parenteral HIV exposure is not 100%.",2019,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","['participants from the Bangkok Tenofovir Study (BTS) with', 'HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients']","['daily oral tenofovir disoproxil fumarate (TDF', 'TDF']",[],"[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042333', 'cui_str': 'Genetic Diversity'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]",[],25.0,0.0747858,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","[{'ForeName': 'Olivia D', 'Initials': 'OD', 'LastName': 'Council', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ruone', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Mock', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Quantitative Sciences and Data Management Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Curlin', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'McNicholl', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Heneine', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Thitima', 'Initials': 'T', 'LastName': 'Cherdtrakulkiat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Rapeepan', 'Initials': 'R', 'LastName': 'Anekvorapong', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'José Gerardo', 'Initials': 'JG', 'LastName': 'García-Lerma', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002390']
3037,31338640,"Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT).","PURPOSE


This study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA).
METHODS


The study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization.
RESULTS


A total of 35 patients were randomized to intervention (N = 18) or placebo (N = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm 2  in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment.
DISCUSSION


In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.",2020,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","['35 patients', 'Breast cancer patients with PCIA', 'breast cancer survivors', 'breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA', 'conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea']","['topical lotion (CG428', 'permanent chemotherapy-induced alopecia', 'CG428 vs. placebo', 'placebo', 'topical lotion, CG428', 'Topical lotion (Batch DT023']","['hair density and thickness', 'hair density', 'safety, tolerability', 'mean hair density (SD', 'hair thickness and density', 'corresponding values for hair thickness', 'hair thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0991552', 'cui_str': 'Topical Lotion'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.617278,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","[{'ForeName': 'Danbee', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Im-Ryung', 'Initials': 'IR', 'LastName': 'Kim', 'Affiliation': 'Cancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Young Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Departments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jinseok.ahn@samsung.com.'}, {'ForeName': 'Juhee', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea. jcho@skku.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04982-z']
3038,31402006,Effects of nutritional supplementation and home visiting on growth and development in young children in Madagascar: a cluster-randomised controlled trial.,"BACKGROUND


Evidence from efficacy trials suggests that lipid-based nutrient supplementation (LNS) and home visits can be effective approaches to preventing chronic malnutrition and promoting child development in low-income settings. We tested the integration of these approaches within an existing, large-scale, community-based nutrition programme in Madagascar.
METHODS


We randomly allocated 125 programme sites to five intervention groups: standard-of-care programme with monthly growth monitoring and nutrition education (T0); T0 plus home visits for intensive nutrition counselling through an added community worker (T1); T1 plus LNS for children aged 6-18 months (T2); T2 plus LNS for pregnant or lactating women (T3); or T1 plus fortnightly home visits to promote and encourage early stimulation (T4). Pregnant women (second or third trimester) and infants younger than 12 months were enrolled in the trial. Primary outcomes were child growth (length-for-age and weight-for-length Z scores) and development at age 18-30 months. Analyses were by intention to treat. The trial was registered with the ISRCTN registry, number ISRCTN14393738.
FINDINGS


The study enrolled 3738 mothers: 1248 pregnant women (250 women in each of the T0, T1, T2, and T4 intervention groups and 248 in the T3 intervention group) and 2490 children aged 0-11 months (497 children in T0, 500 in T1, 494 in T2, 499 in T3, and 500 in T4) at baseline who were assessed at 1-year and 2-year intervals. There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample. However, compared with children in the T0 intervention group, the youngest children (<6 months at baseline) in the T2 and T3 intervention groups who were fully exposed to the child LNS dose had higher length-for-age Z scores (a significant effect of 0·210 SD [95% CI -0·004 to 0·424] for T2 and a borderline effect of 0·216 SD [0·043 to 0·389] for T3) and lower stunting prevalence (-9·0% [95% CI -16·7 to -1·2] for T2 and -8·2% [-15·6 to -0·7] for T3); supplementing mothers conferred no additional benefit.
INTERPRETATION


LNS for children for a duration of 12 months only benefited growth when it began at an early age, suggesting the need to supplement infants at age 6 months in a very low-income context. The lack of effect of the early stimulation messages and home visits might be due to little take-up of behaviour-change messages and delivery challenges facing community health workers.
FUNDING


Eunice Kennedy Shriver National Institutes of Child Health and Human Development, Strategic Impact Evaluation Fund, World Bank Innovation Grant, Early Learning Partnership Grant, World Bank Research Budget, Japan Nutrition Trust Fund, Power of Nutrition, and the National Nutrition Office of Madagascar.",2019,There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample.,"['Pregnant women (second or third trimester) and infants younger than 12 months were enrolled in the trial', 'T3', 'young children in Madagascar', '3738 mothers: 1248 pregnant women (250 women in each of the T0, T1, T2, and T4 intervention groups and 248 in the T3 intervention group) and 2490 children aged 0-11 months (497 children in T0, 500 in T1, 494 in T2, 499 in T3, and 500 in T4) at baseline who were assessed at 1-year and 2-year intervals']","['standard-of-care programme with monthly growth monitoring and nutrition education (T0); T0 plus home visits for intensive nutrition counselling through an added community worker (T1); T1 plus LNS for children aged 6-18 months (T2); T2 plus LNS for pregnant or lactating women (T3); or T1 plus fortnightly home visits to promote and encourage early stimulation (T4', 'lipid-based nutrient supplementation (LNS', 'nutritional supplementation and home visiting']","['child growth (length-for-age and weight-for-length Z scores', 'stunting prevalence', 'higher length-for-age Z scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0024443', 'cui_str': 'Malagasy Republic'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",497.0,0.20103,There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample.,"[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Galasso', 'Affiliation': 'Development Research Group, The World Bank, Washington, DC, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Weber', 'Affiliation': 'School of Community Health Sciences, University of Nevada, Reno, NV, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Ratsifandrihamanana', 'Affiliation': 'Centre Médico-Educatif ""Les Orchidées Blanches"", Antananarivo, Madagascar.'}, {'ForeName': 'Lia C H', 'Initials': 'LCH', 'LastName': 'Fernald', 'Affiliation': 'School of Public Health, University of California Berkeley, Berkeley, CA, USA. Electronic address: fernald@berkeley.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30317-1']
3039,31326345,"Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.","BACKGROUND


Faecal microbiota transplantation (FMT) has shown promise in alleviating the symptoms of irritable bowel syndrome (IBS); however, controlled data on this technique are scarce. The aim of this clinical trial was to assess the efficacy of FMT in alleviating diarrhoea-predominant IBS (IBS-D).
METHODS


We did a double-blind, randomised, placebo-controlled crossover trial in patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres. Patients were randomly assigned (1:1) in blocks of four with a computer-generated randomisation sequence to receive FMT capsules followed by identical-appearing placebo capsules, or placebo capsules followed by FMT capsules. All participants and study team members were masked to randomisation. An independent staff member assigned the treatments according to consecutive numbers. Patients received either 75 FMT capsules (each capsule contained approximately 0·38 g of minimally processed donor stool) or 75 placebo capsules over 3 days (25 capsules per day). All patients crossed over to the alternate treatment at 12 weeks. The primary outcome was difference in IBS-SSS between the groups at 12 weeks. Intention-to-treat analyses were done and all patients who received study drug were included in an adverse events analysis. The trial was terminated during recruitment because results from an interim analysis revealed futility. The study is registered with ClinicalTrials.gov, number NCT02328547.
FINDINGS


From May 28, 2015, to April 21, 2017, 48 patients were randomly assigned to receive FMT first (n=25) or placebo first (n=23). Three participants were lost to follow-up in the FMT group. IBS-SSS did not differ between FMT recipients (mean 221 [SD 105]) and placebo recipients (236 [95]) at 12 weeks (p=0·65), after adjustment for baseline scores. The most common drug-related adverse events included abdominal pain (five [10%] of the 48 participants while receiving FMT capsules vs four [8%] while receiving placebo), nausea (four [8%] vs two [4%]), and exacerbation of diarrhoea (three [6%] vs eight [17%]). One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
INTERPRETATION


FMT was safe, but did not induce symptom relief at 12 weeks compared with placebo. Additional studies are needed to determine the efficacy of FMT for IBS-D.
FUNDING


National Institutes of Health.",2019,"One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
","['diarrhoea-predominant irritable bowel syndrome', 'recipients (mean 221', 'From May 28, 2015, to April 21, 2017, 48 patients', 'patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres']","['Faecal microbiota transplantation (FMT', 'FMT capsules followed by identical-appearing placebo capsules, or placebo capsules followed by FMT capsules', 'FMT', 'placebo', 'Faecal microbiota transplantation', '75 FMT capsules (each capsule contained approximately 0·38']","['abdominal pain', 'IBS-SSS', 'exacerbation of diarrhoea', 'diarrhoea-predominant IBS (IBS-D', 'symptom relief', 'nausea']","[{'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",75.0,0.821614,"One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
","[{'ForeName': 'Olga C', 'Initials': 'OC', 'LastName': 'Aroniadis', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: oaroniad@montefiore.org.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Oneto', 'Affiliation': 'Department of Medicine, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Feuerstadt', 'Affiliation': 'Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan W', 'Initials': 'AW', 'LastName': 'Wolkoff', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Kassam', 'Affiliation': 'Finch Therapeutics Group, Somerville, MA, USA.'}, {'ForeName': 'Rotem Gura', 'Initials': 'RG', 'LastName': 'Sadovsky', 'Affiliation': 'Finch Therapeutics Group, Somerville, MA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'OpenBiome, Cambridge, MA, USA.'}, {'ForeName': 'Shrish', 'Initials': 'S', 'LastName': 'Budree', 'Affiliation': 'OpenBiome, Cambridge, MA, USA; University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Keller', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30198-0']
3040,31882387,Safety and efficacy of epsilon aminocaproic acid (EACA) as an antihemorrhagic drug in bilateral one stage total knee arthroplasty: A double-blind randomized controlled trial.,"BACKGROUND


Antifibrinolytic drugs are widely used to minimize blood loss and transfusion requirements in total knee arthroplasty (TKA). Although tranexamic acid (TXA) has been widely studied for its use in TKA, there are limited studies on epsilon-aminocaproic acid (EACA).
METHODS


In a double-blind randomized control trial, all patients (n = 91) operated with bilateral simultaneous TKA were randomly given either intravenous EACA or placebo (normal saline). A single surgeon performed the TKA with posterior-stabilized implants under tourniquet. A suction drain was placed and kept for 48 h postoperatively. The intraoperative blood loss and drain output were calculated. The postoperative hemoglobin (Hb), drop in Hb, total blood loss, and number of blood transfusions in each group were calculated.
RESULTS


Both of the groups were comparable in terms of age, sex, body mass index, and pre-operative Hb. There was a significant difference between the EACA group and control group in terms of intraoperative blood loss (150 ml vs. 165 ml, P = 0.01), drain output (494 ml vs. 1062 ml, P < 0.001), postoperative Hb (9.9 g/dl vs. 8.6 g/dl, P = 0.002), drop in Hb (2.2 g/dl vs. 3.1 g/dl, P = 0.026) and transfusion rate (median transfusion 0 vs. 1, P < 0.001). The total blood loss, as calculated by the Hb balance method, was significantly less (P < 0.001) in the EACA group (0.99 l) compared with the control group (2.71 l). None of the patients developed any adverse reaction/complication to the drug.
CONCLUSION


Intraoperative administration of EACA significantly decreased the blood loss and postoperative transfusion rates compared with no antifibrinolytic therapy in bilateral simultaneous TKA.",2020,"The total blood loss, as calculated by the Hb balance method, was significantly less (P < 0.001) in the EACA group (0.99 l) compared with the control group (2.71 l).","['total knee arthroplasty (TKA', 'all patients (n\u202f=\u202f91) operated with bilateral simultaneous TKA', 'bilateral one stage total knee arthroplasty']","['tranexamic acid (TXA', 'epsilon aminocaproic acid (EACA', 'intravenous EACA or placebo (normal saline', 'TKA with posterior-stabilized implants under tourniquet', 'EACA']","['total blood loss', 'intraoperative blood loss', 'postoperative hemoglobin (Hb), drop in Hb, total blood loss, and number of blood transfusions', 'adverse reaction/complication', 'blood loss and postoperative transfusion rates', 'postoperative Hb', 'transfusion rate', 'intraoperative blood loss and drain output', 'drain output']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0000608', 'cui_str': 'aminocaproic acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}]",1062.0,0.523017,"The total blood loss, as calculated by the Hb balance method, was significantly less (P < 0.001) in the EACA group (0.99 l) compared with the control group (2.71 l).","[{'ForeName': 'Sujit Kumar', 'Initials': 'SK', 'LastName': 'Tripathy', 'Affiliation': 'Dept. of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, India. Electronic address: sujitortho@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'P Bhaskar', 'Initials': 'PB', 'LastName': 'Rao', 'Affiliation': 'Dept. of Anesthesia and Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Saurav Narayan', 'Initials': 'SN', 'LastName': 'Nanda', 'Affiliation': 'Dept. of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, India.'}, {'ForeName': 'Chandrakanta', 'Initials': 'C', 'LastName': 'Nayak', 'Affiliation': 'Dept. of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, India.'}, {'ForeName': 'Barada P', 'Initials': 'BP', 'LastName': 'Samal', 'Affiliation': 'Dept. of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, India.'}, {'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Dept. of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Dept. of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Hota', 'Affiliation': 'Dept. of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, India.'}]",The Knee,['10.1016/j.knee.2019.09.019']
3041,32101262,Assessment of Long-term Benefit of Intensive Blood Pressure Control on Residual Life Span: Secondary Analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).,"Importance


High blood pressure (BP) is a leading contributor to premature mortality worldwide. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated a 27% reduction in all-cause death with intensive (vs standard) BP control. However, traditional reporting of survival benefits is not readily interpretable outside medical communities.
Objective


To estimate residual life span and potential survival gains with intensive compared with standard BP control in the SPRINT trial using validated nonparametric age-based methods.
Design, Setting, and Participants


This secondary analysis of data from an open-label randomized clinical trial included data from 102 enrolling clinical sites in the United States. Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013. Data analysis occurred from May 2019 to December 2019.
Interventions


A 1:1 randomization to intensive (target, <120 mm Hg) or standard (target, <140 mm Hg) systolic BP targets.
Main Outcomes and Measures


We calculated age-based estimates of projected survival (at a given age) using baseline age rather than time from randomization as the time axis. In each treatment arm at every year of age, residual life span was estimated using the area under the survival curve, up to a maximum of 95 years. Differences in areas under the survival curves reflect the estimated treatment benefits on projected survival.
Results


A total of 9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals). Mean survival benefits with intensive vs standard BP control ranged from 6 months to up to 3 years. At age 50 years, the estimated residual survival was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years]; P = .008). At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years]; P = .03). Absolute survival gains with intensive vs standard BP control decreased with age, but the relative benefits were consistent (4% to 9%).
Conclusions and Relevance


Intensive BP control improves projected survival by 6 months to 3 years among middle-aged and older adults at high cardiovascular risk but without diabetes mellitus. These post hoc actuarial analyses from SPRINT support the survival benefits of intensive BP control, especially among middle-aged adults at risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT01206062.",2020,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","['Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013', 'middle-aged adults at risk', '9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals', 'middle-aged and older adults at high cardiovascular risk but without diabetes mellitus', 'was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years', 'was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years', '102 enrolling clinical sites in the United States']","['Intensive Blood Pressure Control', 'standard BP control']","['residual survival', 'Absolute survival gains', 'Main Outcomes and Measures\n\n\nWe calculated age-based estimates of projected survival', 'survival benefits', 'blood pressure (BP', 'residual life span and potential survival gains', 'Mean survival benefits', 'Residual Life Span', 'Systolic Blood Pressure Intervention Trial (SPRINT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",9361.0,0.209177,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Section for Research, Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.6192']
3042,27611637,Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study.,"RATIONALE


Sevoflurane improves gas exchange, and reduces alveolar edema and inflammation in preclinical studies of lung injury, but its therapeutic effects have never been investigated in acute respiratory distress syndrome (ARDS).
OBJECTIVES


To assess whether sevoflurane would improve gas exchange and inflammation in ARDS.
METHODS


We did a parallel, open-label single-center randomized controlled trial at three intensive care units from a French university hospital between April 2014 and February 2016. Adult patients were randomized within 24 hours of moderate-to-severe ARDS onset to receive either intravenous midazolam or inhaled sevoflurane for 48 hours. The primary outcome was the Pa O 2 /Fi O 2  ratio on Day 2. Secondary endpoints included alveolar and plasma levels of cytokines and soluble form of the receptor for advanced glycation end-products, and safety. Investigators who did the analyses were masked to group allocation. Analysis was by intention to treat.
MEASUREMENTS AND MAIN RESULTS


Twenty-five patients were assigned to the sevoflurane group and 25 to the midazolam group. On Day 2, Pa O 2 /Fi O 2  ratio was higher in the sevoflurane group than in the midazolam group (mean ± SD, 205 ± 56 vs. 166 ± 59, respectively; P = 0.04). There was a significant reduction over time in cytokines and soluble form of the receptor for advanced glycation end-products levels in the sevoflurane group, compared with the midazolam group, and no serious adverse event was observed with sevoflurane.
CONCLUSIONS


In patients with ARDS, use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of epithelial injury and of some inflammatory markers, compared with midazolam. Clinical trial registered with www.clinicaltrials.gov (NCT 02166853).",2017,"There was a significant reduction over time in cytokines and soluble form of the receptor for advanced glycation end-products levels in the sevoflurane group, compared with the midazolam group, and no serious adverse event was observed with sevoflurane.
","['Adult patients', 'Acute Respiratory Distress Syndrome', 'three intensive care units from a French university hospital between April 2014 and February 2016', 'patients with ARDS']","['midazolam', 'Sevoflurane', 'sevoflurane', 'Fi', 'Pa O 2 /Fi', 'midazolam or inhaled sevoflurane']","['alveolar and plasma levels of cytokines and soluble form of the receptor for advanced glycation end-products, and safety', 'O 2  ratio', 'gas exchange and inflammation in ARDS', 'Pa O 2', 'time in cytokines and soluble form of the receptor for advanced glycation end-products levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0101725', 'cui_str': 'Advanced Glycosylation Endproduct Receptors'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",25.0,0.649072,"There was a significant reduction over time in cytokines and soluble form of the receptor for advanced glycation end-products levels in the sevoflurane group, compared with the midazolam group, and no serious adverse event was observed with sevoflurane.
","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Jabaudon', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boucher', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Imhoff', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Chabanne', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Faure', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roszyk', 'Affiliation': '3 Department of Medical Biochemistry and Molecular Biology, and.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Thibault', 'Affiliation': '4 Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France; and.'}, {'ForeName': 'Raiko', 'Initials': 'R', 'LastName': 'Blondonnet', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Clairefond', 'Affiliation': ""2 Clermont Université, Université d'Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Guérin', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Perbet', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cayot', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': '4 Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France; and.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Sapin', 'Affiliation': '3 Department of Medical Biochemistry and Molecular Biology, and.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': '1 Department of Perioperative Medicine.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': '1 Department of Perioperative Medicine.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201604-0686OC']
3043,31682572,Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial.,"BACKGROUND


Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed.
OBJECTIVE


The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study.
METHODS


In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent.
RESULTS


Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001).
CONCLUSIONS


The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants' age and baseline depression severity are of interest in relation to used study methods.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205.",2019,"Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51).","['162 adolescents registered and completed the baseline screening', 'adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70', 'Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70', 'Adolescent Depression', 'adolescent depression, including major depressive episode (MDE']","['ICBT', 'minimal attention control', 'Internet-delivered cognitive behavioral therapies (ICBTs', 'Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions']","['secondary depression outcome', 'average intervention completion', 'Depression', 'depression symptoms', 'self-reported depression level as measured with the Beck Depression Inventory']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4517493', 'cui_str': '1.15'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0946707', 'cui_str': 'Chat'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",162.0,0.261322,"Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51).","[{'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Byléhn', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dahlström Nysäter', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Holmlund', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lindegaard', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Åberg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bergman Nordgren', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zetterqvist', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Journal of medical Internet research,['10.2196/13393']
3044,32089455,Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2 in First-line Treatment of Patients With Metastatic Colorectal Cancer: A Multicenter Randomized Phase II Trial of the Gruppo Oncologico dell'Italia Meridionale (GOIM 2802).,"INTRODUCTION


Biweekly schedule of XELOX-2 (capecitabine plus oxaliplatin) showed interesting results in first-line therapy of patients with metastatic colorectal cancer (mCRC). Bevacizumab plus FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil) is among standard first-line treatment options in this setting. We performed a phase II randomized trial in order to evaluate the activity of bevacizumab plus either FOLFOX-4 or XELOX-2 in first-line therapy of patients with mCRC.
MATERIALS AND METHODS


Patients with mCRC were randomized, in a 1:2 ratio, to first-line bevacizumab plus either FOLFOX-4 (Arm A), as calibration arm, or XELOX-2 (Arm B), up to 12 cycles. Patients without progression were further randomized to maintenance bevacizumab alone or with the same induction fluoropyrimidine. The primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival, overall survival, and toxicity. The study design was formally non-comparative, but exploratory comparison was performed.
RESULTS


Forty-five patients were randomized in arm A and 87 in arm B with an ORR of 55.6% versus 48.3% (P = .43), respectively. After a median follow-up of 47.2 months, progression-free survival was 10.0 versus 9.9 months (hazard ratio, 0.96; 95% confidence interval, 0.65-1.41; P = .84) and overall survival was 29.8 versus 25.0 months (hazard ratio, 1.21; 95% confidence interval, 0.77-1.92; P = .41), respectively. The main grade 3 to 4 toxicities (% A/B) were: neutropenia 15/3 and nausea 9/5.
CONCLUSION


This exploratory analysis showed that biweekly XELOX-2 plus bevacizumab has a comparable ORR with FOLFOX-4 plus bevacizumab in patients with mCRC.",2020,This exploratory analysis showed that biweekly XELOX-2 plus bevacizumab has a comparable ORR with FOLFOX-4 plus bevacizumab in patients with mCRC.,"['Patients With Metastatic Colorectal Cancer', 'Patients without progression', 'Patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', 'patients with mCRC', 'Forty-five patients']","['XELOX-2 (capecitabine plus oxaliplatin', 'fluoropyrimidine', 'bevacizumab plus either FOLFOX-4 or XELOX-2', 'maintenance bevacizumab', 'bevacizumab plus either FOLFOX-4 (Arm A), as calibration arm, or XELOX-2', 'bevacizumab', 'Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2', 'Bevacizumab plus FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil', 'XELOX-2 plus bevacizumab', ""Gruppo Oncologico dell'Italia""]","['neutropenia 15/3 and nausea 9/5', 'objective response rate (ORR); secondary endpoints included progression-free survival, overall survival, and toxicity', 'toxicities', 'progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",45.0,0.0820604,This exploratory analysis showed that biweekly XELOX-2 plus bevacizumab has a comparable ORR with FOLFOX-4 plus bevacizumab in patients with mCRC.,"[{'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Division of Medical Oncology, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo (Foggia), Italy. Electronic address: e.maiello@libero.it.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Di Maggio', 'Affiliation': 'Division of Medical Oncology, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo (Foggia), Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology Unit, Ospedale Garibaldi, Catania, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology Unit, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giuliani', 'Affiliation': 'Medical Oncology Unit, National Cancer Institute IRCCS ""Giovanni Paolo II"", Bari, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Oncology Unit, SG Moscati Hospital, Taranto, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rinaldi', 'Affiliation': 'Ospedale Civile, Castellaneta (Taranto), Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Febbraro', 'Affiliation': 'Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli, Benevento, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Division of Medical Oncology, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo (Foggia), Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology Unit, Department of Onco-Hematology, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture (Potenza), Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Division of Medical Oncology, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo (Foggia), Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Gruppo Oncologico Italia Meridionale (GOIM) Trial Office, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin, Turin, Italy; Medical Oncology Unit, ""Ordine Mauriziano"" Hospital, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Gruppo Oncologico Italia Meridionale (GOIM) Trial Office, Bari, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology Unit, Ospedale Garibaldi, Catania, Italy.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.01.003']
3045,32095884,Comparison of Mill Suss™-guided radial artery catheterization with the long-axis in-plane ultrasound-guided method under general anesthesia: a randomized controlled trial.,"Continuous arterial blood pressure measurement is an effective perioperative monitoring method in patients with high-risk comorbidities. Recently, ultrasound guidance has been reported to facilitate radial artery catheterization. A new device, Mill Suss™, has also been developed for visualization of the radial artery and superficial veins using near-infrared laser light. In this study, we hypothesized that the Mill Suss-guided method might reduce the time and the number of attempts required for radial artery catheterization under general anesthesia, as compared to the long-axis in-plane ultrasound-guided method. Seventy-two adult patients aged 20-80 years, ASA physical status I or II, were randomly assigned to the Mill Suss-guided group (Group M: n = 36) or ultrasound-guided group (Group U: n = 36). Primary outcomes were the time required for successful radial artery catheterization and the number of cannulation attempts. There were no significant differences in the characteristics of patients between the two groups. The time required for successful radial artery catheterization was significantly shorter in Group M than in Group U. The number of attempts for successful cannulation was not statistically significantly different between the two groups. However, the results might be different among anesthesiologists well experienced in the ultrasound-guided method.",2020,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"['Seventy-two adult patients aged 20-80\xa0years, ASA physical status I or II', 'patients with high-risk comorbidities', 'plane ultrasound-guided method under general anesthesia']","['Mill Suss-guided group (Group M: n\u2009=\u200936) or ultrasound-guided group', 'Continuous arterial blood pressure measurement', 'Mill Suss™-guided radial artery catheterization']","['time required for successful radial artery catheterization', 'number of attempts for successful cannulation', 'time required for successful radial artery catheterization and the number of cannulation attempts']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]",72.0,0.0601745,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"[{'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Osuda', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. elysium102@hotmail.com.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Ihara', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02749-z']
3046,32106792,Alendronate/Vitamin D for attenuating bone mineral density loss during antiretroviral initiation: a pilot randomized controlled trial.,"Background:  Antiretroviral therapy (ART) initiation is associated with decreases in bone mineral density (BMD). Objectives:  To plan for a larger trial, we sought to obtain preliminary estimates for the difference in the change in BMD at 48 weeks achieved with 24 weeks of prophylactic alendronate/vitamin D during ART initiation compared to no intervention, the within-group standard deviation of this change, and intra-patient correlation coefficient for repeated BMDs. Secondary objectives included assessing enrollment feasibility, treatment acceptability, adherence and safety. Methods:  We randomized treatment-naïve HIV-positive adults initiating tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat or abacavir/lamivudine/dolutegravir 1:1:1 to immediate alendronate/vitamin D3 70 mg/5600 IU for 24 weeks (concomitant treatment arm, CTA), the same intervention starting 24 weeks after study entry (delayed treatment arm, DTA), or no bone anti-resorptive therapy (standard of care, SOC). We assessed BMD, acceptability, adverse events and drug adherence at baseline, week 24 and week 48. Results:  Of 29 included participants, 72% initiated TDF/FTC/ELV/c and 28% initiated ABC/3TC/DTG. Median (IQR) CD4 count was 388 (303,525) cells/mm 3  and median plasma HIV RNA was 4.45 (2.26, 4.84) log 10  copies/mL. The mean (SD) percentage change in BMD for the CTA and DTA combined was 1.95% (2.53%), 0.38% (3.34%), and -0.57% (3.50%) at the lumbar spine, femoral neck and total hip respectively at 48 weeks. The ICC among repeated measurements of BMD was 0.978, 0.964, and 0.967 at these sites, respectively. Enrollment feasibility, drug acceptability, adherence, and tolerability were good. Conclusions:  Our findings inform the sample size for a larger trial of bone anti-resorptive therapy during ART initiation and support feasibility.",2019,"The mean (SD) percentage change in BMD for the CTA and DTA combined was 1.95% (2.53%), 0.38% (3.34%), and -0.57% (3.50%) at the lumbar spine, femoral neck and total hip respectively at 48 weeks.","['Results:  Of 29 included participants, 72% initiated', 'naïve HIV-positive adults initiating']","['no bone anti-resorptive therapy (standard of care, SOC', 'Alendronate/Vitamin D', 'Antiretroviral therapy', 'tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat or abacavir/lamivudine/dolutegravir 1:1:1 to immediate alendronate/vitamin D3', 'prophylactic alendronate/vitamin D']","['mean (SD) percentage change in BMD', 'enrollment feasibility, treatment acceptability, adherence and safety', 'bone mineral density (BMD', 'BMD, acceptability, adverse events and drug adherence', 'Median (IQR) CD4 count', 'Enrollment feasibility, drug acceptability, adherence, and tolerability', 'BMD', 'bone mineral density loss', 'median plasma HIV RNA']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C2606637', 'cui_str': 'elvitegravir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",29.0,0.480613,"The mean (SD) percentage change in BMD for the CTA and DTA combined was 1.95% (2.53%), 0.38% (3.34%), and -0.57% (3.50%) at the lumbar spine, femoral neck and total hip respectively at 48 weeks.","[{'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Division of Infectious Diseases, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'CIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Raboud', 'Affiliation': 'Toronto General Hospital Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Attia', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Walmsley', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",HIV research & clinical practice,['10.1080/25787489.2020.1730114']
3047,32106328,The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting? - Reproducibility of the Renal Resistive Index.,"PURPOSE


To assess the reproducibility of the renal resistive index (RRI) in a routine clinical setting.
MATERIALS AND METHODS


22 patients with a kidney allograft and 19 physicians participated in our prospective study. Within 2 hours each patient was examined by 5 different physicians using 2 out of 3 different, randomly allocated ultrasound machines. Each investigator determined the hilar and parenchymal RRI of the allograft. The reproducibility and reproducibility limit of the RRI were assessed as well as Cronbach's alpha and the intraclass correlation coefficient (ICC). The deviation of the RRI from the mean RRI over the 5 measurements was used as an indicator of reproducibility. The impact of the ultrasound machine, examiner's level of experience, and kidney function impairment (GFR < 45 ml/min) was assessed with the Kruskal-Wallis test. The bivariate linear correlation of the minimal transplant distance from the body surface with the variance of the parenchymal RRI was analyzed.
RESULTS


A reproducibility of 0.045 with a reproducibility limit of 0.124 was found for the parenchymal RRI. The ICC between RRIs was good with 0.852 for the parenchymal RRI and 0.868 for the hilar RRI. The type of ultrasound machine used was found to have a significant impact on the deviation of the parenchymal RRI (Kruskal-Wallis-Test, p = 0.003). Variance in serial parenchymal RRI measurements correlated significantly with the depth of the kidney transplant (p = 0.001).
CONCLUSION


While the RRI is generally sufficiently reproducible, the type of ultrasound machine used and the depth of the kidney transplant within the recipient's body have a significant impact on reproducibility.
KEY POINTS


· The renal resistive index (RRI) in allografts is reproducible.. · The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al. The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting?. Fortschr Röntgenstr 2020; 192: 561 - 566.",2020,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al.",['22 patients with a kidney allograft and 19 physicians participated in our prospective study'],[],"['Variance in serial parenchymal RRI measurements', 'reproducibility of the renal resistive index (RRI', 'Renal Resistive Index in Allografts', 'hilar and parenchymal RRI of the allograft', 'reproducibility and reproducibility limit of the RRI', 'deviation of the parenchymal RRI', 'renal resistive index (RRI', 'Renal Resistive Index', ' Reproducibility of the Renal Resistive Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]",[],"[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",22.0,0.0197898,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al.","[{'ForeName': 'Dorothea Cornelia', 'Initials': 'DC', 'LastName': 'Theilig', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Münzfeld', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Timo Alexander', 'Initials': 'TA', 'LastName': 'Auer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Feldhaus', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Krüger', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dürr', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Geisel', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}]",RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin,['10.1055/a-1086-5191']
3048,32101259,A New Equation for Calculation of Low-Density Lipoprotein Cholesterol in Patients With Normolipidemia and/or Hypertriglyceridemia.,"Importance


Low-density lipoprotein cholesterol (LDL-C), a key cardiovascular disease marker, is often estimated by the Friedewald or Martin equation, but calculating LDL-C is less accurate in patients with a low LDL-C level or hypertriglyceridemia (triglyceride [TG] levels ≥400 mg/dL).
Objective


To design a more accurate LDL-C equation for patients with a low LDL-C level and/or hypertriglyceridemia.
Design, Setting, and Participants


Data on LDL-C levels and other lipid measures from 8656 patients seen at the National Institutes of Health Clinical Center between January 1, 1976, and June 2, 1999, were analyzed by the β-quantification reference method (18 715 LDL-C test results) and were randomly divided into equally sized training and validation data sets. Using TG and non-high-density lipoprotein cholesterol as independent variables, multiple least squares regression was used to develop an equation for very low-density lipoprotein cholesterol, which was then used in a second equation for LDL-C. Equations were tested against the internal validation data set and multiple external data sets of either β-quantification LDL-C results (n = 28 891) or direct LDL-C test results (n = 252 888). Statistical analysis was performed from August 7, 2018, to July 18, 2019.
Main Outcomes and Measures


Concordance between calculated and measured LDL-C levels by β-quantification, as assessed by various measures of test accuracy (correlation coefficient [R2], root mean square error [RMSE], mean absolute difference [MAD]), and percentage of patients misclassified at LDL-C treatment thresholds of 70, 100, and 190 mg/dL.
Results


Compared with β-quantification, the new equation was more accurate than other LDL-C equations (slope, 0.964; RMSE = 15.2 mg/dL; R2 = 0.9648; vs Friedewald equation: slope, 1.056; RMSE = 32 mg/dL; R2 = 0.8808; vs Martin equation: slope, 0.945; RMSE = 25.7 mg/dL; R2 = 0.9022), particularly for patients with hypertriglyceridemia (MAD = 24.9 mg/dL; vs Friedewald equation: MAD = 56.4 mg/dL; vs Martin equation: MAD = 44.8 mg/dL). The new equation calculates the LDL-C level in patients with TG levels up to 800 mg/dL as accurately as the Friedewald equation does for TG levels less than 400 mg/dL and was associated with 35% fewer misclassifications when patients with hypertriglyceridemia (TG levels, 400-800 mg/dL) were categorized into different LDL-C treatment groups.
Conclusions and Relevance


The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel. It will allow for more accurate calculation of LDL-C level in patients with low LDL-C levels and/or hypertriglyceridemia (TG levels, ≤800 mg/dL) and thus should improve the use of LDL-C level in cardiovascular disease risk management.",2020,The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel.,"['8656 patients seen at the National Institutes of Health Clinical Center between January 1, 1976, and June 2, 1999, were analyzed by the β-quantification reference method (18\u202f715 LDL-C test results', 'patients with hypertriglyceridemia ', 'patients with a low LDL-C level and/or hypertriglyceridemia', 'Patients With Normolipidemia and/or Hypertriglyceridemia', 'patients with a low LDL-C level or hypertriglyceridemia (triglyceride [TG] levels ≥400 mg/dL']",[],"['square error [RMSE], mean absolute difference [MAD]), and percentage of patients misclassified at LDL-C treatment thresholds', 'Importance\n\n\nLow-density lipoprotein cholesterol (LDL-C', 'Measures\n\n\nConcordance between calculated and measured LDL-C levels by β-quantification', 'root mean']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0853085', 'cui_str': 'Decreased LDL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",[],"[{'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}]",,0.0197011,The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel.,"[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Roa', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mohmed', 'Initials': 'M', 'LastName': 'Ashmaig', 'Affiliation': 'Prism Health Dx Inc, Austin, Texas.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Warnick', 'Affiliation': 'Prism Health Dx Inc, Austin, Texas.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Pacific Biomarker, Seattle, Washington.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Fleming', 'Affiliation': 'Department of Science and Technology, Laboratory Corporation of America Holdings, Burlington, North Carolina.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Otvos', 'Affiliation': 'NMR Diagnostics, Laboratory Corporation of America Holdings, Burlington, North Carolina.'}, {'ForeName': 'Jeff W', 'Initials': 'JW', 'LastName': 'Meeusen', 'Affiliation': 'Cardiovascular Laboratory Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Delaney', 'Affiliation': 'Cardiovascular Laboratory Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Allan S', 'Initials': 'AS', 'LastName': 'Jaffe', 'Affiliation': 'Division of Clinical Core Laboratory Services, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shamburek', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Amar', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0013']
3049,30659924,Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods.,"Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Importantly, PPI metabolism and efficacy depend on CYP2C19 genotype. The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms. This study has an innovative design to both assess the efficacy of genotype-tailored PPI dosing and perform pharmacokinetic modeling of the oral PPI Lansoprazole. Children ages 6-17 years old with clinician-diagnosed asthma and mild GERD symptoms will submit a saliva sample for CYP2C19 genotyping. Participants will undergo a two-step randomization to: (1) genotype-tailored versus conventional dosing of open-label oral lansoprazole for pharmacokinetic modeling, and (2) genotype-tailored lansoprazole daily versus placebo for 24 weeks to determine the effect of genotype-tailored PPI dosing on asthma control. Measures of asthma control, spirometry, and nasal washes during acute illnesses will be collected at 8-week intervals throughout the study. GenARA will better define the effects of CYP2C19 genotype on the dose response of lansoprazole in children and adolescents and assess if a novel dosing regimen improves GERD and asthma control.",2019,"The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms.","['children and adolescents', 'Children with Uncontrolled Asthma (GenARA', 'children with uncontrolled asthma (GenARA', 'Children ages 6-17\u202fyears old with clinician-diagnosed asthma and mild GERD symptoms will submit a saliva sample for CYP2C19 genotyping', 'children with inadequately controlled asthma and GERD symptoms']","['placebo', 'genotype-tailored versus conventional dosing of open-label oral lansoprazole for pharmacokinetic modeling, and (2) genotype-tailored lansoprazole daily versus placebo', 'lansoprazole', 'oral PPI Lansoprazole', 'inhibitor (PPI', 'Proton pump']","['PPI metabolism and efficacy', 'asthma symptoms', 'asthma control, spirometry, and nasal washes during acute illnesses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0018440', 'cui_str': 'Proton Pump'}]","[{'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",,0.0367684,"The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': ""Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States.""}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Blake', 'Affiliation': ""Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Mougey', 'Affiliation': ""Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Franciosi', 'Affiliation': ""Department of Pediatrics, Nemours Children's Hospital, Nemours Children's Health System, Orlando, FL, United States.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL, United States.'}, {'ForeName': 'Md Jobayer', 'Initials': 'MJ', 'LastName': 'Hossain', 'Affiliation': 'Department of Biomedical Research, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE, United States.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Cobbaert', 'Affiliation': 'Department of Pharmacometrics, Duke Clinical Research Institute, Durham, NC, United States.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Fischer', 'Affiliation': ""Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States.""}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': ""Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States. Electronic address: jason.lang@duke.org.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.009']
3050,31923087,Darunavir Pharmacokinetics With an Increased Dose During Pregnancy.,"BACKGROUND


This study aims to evaluate the pharmacokinetics of an increased dose of darunavir (800 mg twice daily) with 100 mg ritonavir during pregnancy and postpartum.
METHODS


Darunavir (DRV) and ritonavir (RTV; r) intensive pharmacokinetic evaluations were performed at steady state during the second and third trimesters of pregnancy (DRV/r 800/100 mg bid) and 2-3 weeks postpartum (DRV/r 600/100 mg twice daily). Plasma concentrations of darunavir and ritonavir were measured using high-performance liquid chromatography. Target darunavir area under the concentration time curve (AUC) was >70% (43.6 μg × h/mL) of median AUC (62.3 μg × h/mL) in nonpregnant adults on twice daily darunavir-ritonavir 600/100 mg.
RESULTS


Twenty-four women were included in the analysis. Darunavir AUC0-12 was lower with the increased dose during the second {[geometric mean ratio (GMR) of 0.62 (IQR 0.44-0.88); P = 0.055]} and third trimesters [GMR 0.64 (IQR 0.55-0.73); P = <0.001] compared with postpartum. Darunavir apparent clearance was higher during the second [GMR 1.77 (IQR 1.24-2.51); P = 0.039] and third trimesters [GMR 2.01 (IQR 1.17-2.35); P = <0.001] compared with postpartum. Similarly, ritonavir AUC0-12 was lower during the third trimester [GMR 0.65 (IQR 0.52-0.82); P = 0.007] compared with postpartum, whereas its apparent clearance was higher during the third trimester [GMR 1.53 (IQR 1.22-1.92); P = 0.008] compared with postpartum. No major drug-related safety concerns were noted.
CONCLUSIONS


Increasing darunavir dose to 800 mg BID failed to significantly increase darunavir exposure compared with 600 mg BID. Other strategies, such as increasing the ritonavir dose should be investigated.",2020,Darunavir apparent clearance was higher in during the second (GMR 1.77 (IQR 1.24-2.51; p=0.039) and third trimesters (GMR 2.01 (IQR 1.17-2.35; p=<0.001) compared to postpartum.,['Twenty-four women were included in the analysis'],"['darunavir', 'ritonavir (RTV', 'ritonavir']","['r) intensive pharmacokinetic evaluations', 'Plasma concentrations of darunavir and ritonavir', 'Darunavir apparent clearance', 'Target darunavir area under the concentration time curve (AUC', 'ritonavir AUC0-12']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0231969', 'cui_str': 'Regional tidal volume, function (observable entity)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",24.0,0.104831,Darunavir apparent clearance was higher in during the second (GMR 1.77 (IQR 1.24-2.51; p=0.039) and third trimesters (GMR 2.01 (IQR 1.17-2.35; p=<0.001) compared to postpartum.,"[{'ForeName': 'Ahizechukwu C', 'Initials': 'AC', 'LastName': 'Eke', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Stek', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Southern California School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Kreitchmann', 'Affiliation': 'HIV/AIDS Research Department, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, SR, Brazil.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Pediatric Medicine Research Branch, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Clinical Pharmacy and Pediatrics, University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'Department of Clinical Pharmacy and Pediatrics, University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002261']
3051,32066404,"Can childcare work be designed to promote moderate and vigorous physical activity, cardiorespiratory fitness and health? Study protocol for the Goldilocks-childcare randomised controlled trial.","BACKGROUND


Despite extensive efforts, issues like obesity and poor physical capacity remain challenges for a healthy work life in several occupations. The Goldilocks work principle offers a new approach, encouraging design of productive work to promote physical capacity and health. This paper presents the protocol for the Goldilocks-childcare study, a randomised controlled intervention trial aiming to evaluate the effectiveness of implementing the Goldilocks work principle in childcare. The primary aim of the intervention is to increase time in moderate to vigorous physical activity (MVPA) by having the childcare workers act as active role models for children in daily playful physical activities, and thereby improve cardiorespiratory fitness and health of the workers.
METHODS


The study is a cluster-randomised trial with a usual-practice wait-list control group. The 10-week intervention consists of two phases. In the first, the childcare workers will participate in two participatory workshops aiming to a) develop playful physical activities ('Goldilocks-games') for children in which childcare workers participate as active role models at MVPA intensity, and b) develop action plans for implementation of the Goldilocks-games in daily work routines. In the second phase, childcare institutions will implement the Goldilocks-games. The primary outcome is working time spent in MVPA, and secondary outcomes are cardiorespiratory fitness, sleeping heart rate, perceived need for recovery, and productivity. Primary outcome and process evaluation will be based on direct measurements of physical activity and heart rate, determination of cardiorespiratory fitness, and questionnaires.
DISCUSSION


If proven effective, the Goldilocks work principle has a large potential for promoting sustainable health and working lives of childcare workers.
TRIAL REGISTRATION


ISRCTN, ISRCTN15644757, Registered 25th December 2019.",2020,"If proven effective, the Goldilocks work principle has a large potential for promoting sustainable health and working lives of childcare workers.
",['childcare'],"[""playful physical activities ('Goldilocks-games""]","['direct measurements of physical activity and heart rate, determination of cardiorespiratory fitness, and questionnaires', 'working time spent in MVPA, and secondary outcomes are cardiorespiratory fitness, sleeping heart rate, perceived need for recovery, and productivity']",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.0733052,"If proven effective, the Goldilocks work principle has a large potential for promoting sustainable health and working lives of childcare workers.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lidegaard', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark. vmlg@novonordisk.com.'}, {'ForeName': 'Anders Fritz', 'Initials': 'AF', 'LastName': 'Lerche', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Pernille Kold', 'Initials': 'PK', 'LastName': 'Munch', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Kathrine Greby', 'Initials': 'KG', 'LastName': 'Schmidt', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Lund', 'Initials': 'CL', 'LastName': 'Rasmussen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Diana Nørregaard', 'Initials': 'CDN', 'LastName': 'Rasmussen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Mathiassen', 'Affiliation': 'Department of Occupational Health Sciences and Psychology, Centre for Musculoskeletal Research, University of Gävle, Gävle, Sweden.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Straker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Holtermann', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}]",BMC public health,['10.1186/s12889-020-8291-y']
3052,32066407,Limits of the social-benefit motive among high-risk patients: a field experiment on influenza vaccination behaviour.,"BACKGROUND


Influenza vaccine uptake remains low worldwide, inflicting substantial costs to public health. Messages promoting social welfare have been shown to increase vaccination intentions, and it has been recommended that health professionals communicate the socially beneficial aspects of vaccination. We provide the first test whether this prosocial vaccination hypothesis applies to actual vaccination behaviour of high-risk patients.
METHODS


In a field experiment at a tertiary care public hospital in Istanbul, Turkey, we compare the effects of two motivational messages for promoting vaccination. Using a between-subjects single-blind experimental design patients were randomly assigned to frames emphasizing the vaccine's benefits to self (n = 125) or social benefits (n = 119). Free influenza vaccination was offered to each patient.
RESULTS


Among 222 patients who were not vaccinated for the season prior to the study (72% medically assessed to be at high risk), 42% in the self-benefit frame chose to receive a vaccination compared with 34% in the social-benefits frame, but the difference was not statistically significant (aOR = 1.63, 95% CI 0.90 to 2.95, p = 0.108). Reasons for vaccination focused primarily on self-benefit (67%) rather than social-benefit (5%). Exploratory analysis showed that the effect of messages depended on patient perception of risk group membership (aOR High  / aOR Low  = 5.59, 95% CI 1.30 to 24.05, p = 0.021). In particular, emphasis on self-benefit was more influential among patients who perceived themselves to be in the risk group (aOR = 6.22, 95% CI 1.69 to 22.88, p = 0.006).
CONCLUSIONS


In contrast to the literature observing intentions of low-risk populations, we found no evidence that social-benefit motivates actual vaccination behaviour among a high-risk patient population. Instead, those who self-categorize as being in the high risk group are more motivated by the self-benefit message. Our results suggest that a stratified approach can improve coverage: even if an emphasis on social-benefit could be effective among low-risk groups, an emphasis on self-benefit holds more promise for increasing vaccination in medical organizational settings where high-risk groups are prevalent.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04230343 Retrospectively registered on the 13th January 2020.",2020,"In contrast to the literature observing intentions of low-risk populations, we found no evidence that social-benefit motivates actual vaccination behaviour among a high-risk patient population.","['222 patients who were not vaccinated for the season prior to the study (72% medically assessed to be at high risk', 'high-risk patients']","[""vaccine's benefits to self (n\u2009=\u2009125) or social benefits""]",['patient perception of risk group membership'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",,0.054991,"In contrast to the literature observing intentions of low-risk populations, we found no evidence that social-benefit motivates actual vaccination behaviour among a high-risk patient population.","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Isler', 'Affiliation': 'Centre for Behavioural Economics, Society and Technology (BEST), School of Economics and Finance, Queensland University of Technology (QUT), Brisbane, 4000, Australia.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Isler', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Kopsacheilis', 'Affiliation': 'Centre for Decision Research and Experimental Economics (CeDEx), University of Nottingham, Nottingham, UK. orestis.kopsacheilis@nottingham.ac.uk.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, NG7 2RD, UK. eamonn.ferguson@nottingham.ac.uk.'}]",BMC public health,['10.1186/s12889-020-8246-3']
3053,32089359,Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,"BACKGROUND


Very long-term mortality in men with early prostate cancer treated with surgery versus observation is uncertain.
OBJECTIVE


To determine long-term effects of surgery versus observation on all-cause mortality for men with early prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS


This study evaluated long-term follow-up of a randomized trial conducted at the US Department of Veterans Affairs and National Cancer Institute sites. The participants were men (n=731) ≤75yr of age with localized prostate cancer, prostate-specific antigen (PSA) <50ng/ml, life expectancy ≥10yr, and medically fit for surgery.
INTERVENTION


Radical prostatectomy versus observation.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


All-cause mortality was assessed in the entire cohort and patient and tumor subgroups. Intention-to-treat analysis was conducted using Kaplan-Meier methods with log-rank tests and Cox proportional hazard models; cumulative mortality incidence, between-group differences, and relative risks were also assessed at predefined time periods.
RESULTS AND LIMITATIONS


During 22.1yr (median follow-up for survivors=18.6yr; interquartile range: 16.6-20.0), 515 men died; 246 of 346 men (68%) were assigned to surgery versus 269 of 367 (73%) assigned to observation (hazard ratio 0.84 [95% confidence interval {CI}: 0.70-1.00]; p= 0.044 [absolute risk reduction = 5.7 percentage points, 95% CI: -0.89 to 12%]; relative risk: 0.92 [95% CI: 0.84-1.01]). The restricted mean survival in the surgical group was 13.6 yr (95% CI: 12.9-14.3) versus 12.6 yr (95% CI: 11.8-13.3) in the observation group; a mean of 1 life-year was gained with surgery. Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease. Results were not adjusted for multiple comparisons, and we could not assess outcomes other than all-cause mortality.
CONCLUSIONS


Surgery was associated with small very long-term reductions in all-cause mortality and increases in years of life gained. Absolute effects did not vary markedly by patient characteristics. Absolute effects and mean survival were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease.
PATIENT SUMMARY


In this randomized study, we evaluated death from any cause in men with early prostate cancer treated with either surgery or observation. Overall, surgery may provide small very long-term reductions in death from any cause and increases in years of life gained. Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease. Strategies are needed to identify men needing and benefitting from surgery while reducing ineffective treatment and overtreatment.",2020,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","['men with early prostate cancer', 'Veterans Affairs and National Cancer Institute sites', '50', 'men with early prostate cancer treated with either surgery or observation', 'participants were men (n\u202f=\u202f731) ≤75', 'Clinically Localized Prostate Cancer', 'yr of age with localized prostate cancer, prostate-specific antigen (PSA']","['Radical prostatectomy versus observation', 'Radical Prostatectomy or Observation']","['mean survival', 'Absolute effects and mean survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.16697,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilt', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA. Electronic address: Tim.wilt@va.gov.'}, {'ForeName': 'Tien N', 'Initials': 'TN', 'LastName': 'Vo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Langsetmo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dahm', 'Affiliation': 'Minneapolis VA Section of Urology, Minneapolis MN, USA; Department of Urology, University of Minnesota, Minneapolis MN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wheeler', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': 'VA Medical Center, Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Urology, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California at San Francisco, CA, USA; Department of Urology and Epidemiology and Biostatistics, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Brawer', 'Affiliation': 'MDx Health, Irvine, CA, USA; Nanospectra Biosciences, Houston, TX, USA.'}]",European urology,['10.1016/j.eururo.2020.02.009']
3054,32088668,Efficacy of Live Versus Recorded Harp Music in Reducing Preoperative Stress and Fear Related to Minor Surgery: A Pilot Study.,"Context


Before surgery, people can become concerned about risks that may arise, experiencing fear and stress. It is possible to implement nonpharmacological interventions to reduce fear and preoperative stress using expressive arts, including music therapy.
Objective


The aim of this study was to assess the effectiveness of live harp music and compare it with that of recorded harp music in reducing preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR).
Design


The study was a pilot study, with a quasi-experimental design.
Setting


The study took place in a surgery unit's clinic, held weekly, in a teaching hospital in Milan, Italy.
Participants


Participants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group. No one dropped out of the study.
Intervention


The intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention. The research team had defined a musical protocol based on the theoretical principles of harp therapy.
Outcome Measures


Before and after the musical intervention, the research team investigated each patient's level of fear and stress, using the same self-evaluation questionnaire (HR) and blood pressure (BP).
Results


Of the 46 participants, 46% were male, and 54% were female. Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups. The live harp music was more effective in reducing HR (P = .001) and diastolic BP (P = .007), than was recorded harp music, with P = .151 and P = .164, respectively. Based on the results, the research team determined that a randomized controlled trial (RCT) would require 90 patients for both the intervention and control groups.
Conclusions


Harp therapy brought benefits by significantly reducing fear and stress and HR and BP. It would be useful to perform a multicenter RCT to confirm these results.",2020,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"['46 participants, 46% were male, and 54% were female', 'Participants\n\n\nParticipants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group']","['intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention', 'musical intervention', 'recorded harp music', 'live harp music', 'Live Versus Recorded Harp Music']","['diastolic BP', 'preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR', 'Preoperative Stress and Fear Related to Minor Surgery', 'fear and stress and HR and BP', 'self-evaluation questionnaire (HR) and blood pressure (BP', 'Fear values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgery'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.0333677,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"[{'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Gelatti', 'Affiliation': ''}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Viganò', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Borsani', 'Affiliation': ''}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Conistabile', 'Affiliation': ''}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Bonetti', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3055,32060062,Celecoxib in lymphangioleiomyomatosis: results of a phase I clinical trial.,,2020,,['LAM'],['Celecoxib'],[],"[{'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}]",[],,0.0757605,,"[{'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'El-Chemaly', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Taveira-DaSilva', 'Affiliation': 'Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Bagwe', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Klonowska', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Machado', 'Affiliation': 'Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Lamattina', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': 'Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Julien-Williams', 'Affiliation': 'Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Maurer', 'Affiliation': 'The Harvard Clinical and Translational Science Center, Boston, MA, USA.'}, {'ForeName': 'Ivan O', 'Initials': 'IO', 'LastName': 'Rosas', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Henske', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kwiatkowski', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",The European respiratory journal,['10.1183/13993003.02370-2019']
3056,32085906,Association of the Intensive Lifestyle Intervention With Total Knee Replacement in the Look AHEAD (Action for Health in Diabetes) Clinical Trial.,"BACKGROUND


Evidence has established obesity as a risk factor for total knee replacement (TKR) due to osteoarthritis. Obesity is a risk factor for TKR. Randomized trials such as Look AHEAD (Action for Health in Diabetes) have shown long-term successful weight loss with an intensive lifestyle intervention (ILI). It is unknown, however, if intentional weight loss can reduce the risk of TKR.
METHODS


Look AHEAD randomized persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE). Reported knee pain was assessed using the Visual Analog Scale and Western Ontario McMaster University Osteoarthritis Index questionnaire in 5125 participants without previous TKR. Cox proportional hazard regression was used to model differences in risk of TKR in relation to randomization group assignment (ILI vs DSE) along with baseline body mass index category and baseline knee pain as potential confounders from baseline through Look AHEAD-Extension.
RESULTS


Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores did not differ by treatment assignment (ILI: 3.6 ± 2.9, DSE: 3.9 ± 3.0, P = .08); as expected due to randomization. During follow up, the 631 (12%) participants who reported having a TKR were more likely to have been heavier (P < .001) and older (P < .001) at enrollment, but risk of TKR did not differ by treatment group assignment (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.91-1.25, P = .43). Heterogeneity of treatment effect was observed according to baseline knee pain (interaction P = .02). In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96). However, in persons with knee pain at baseline, there was no statistically significant association of treatment assignment with respect to subsequent TKR incidence (HR 1.11, 95% CI 0.92-1.33).
CONCLUSION


Findings suggest that intensive lifestyle change including physical activity, dietary restriction and behavioral changes to achieve weight loss for prevention of TKR may be most effective in preventing TKR prior to the development of knee pain.",2020,"In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96).","['persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE', '5125 participants without previous TKR', 'Diabetes', 'Health in Diabetes']",['Intensive Lifestyle Intervention With Total Knee Replacement'],"['Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores', 'risk of TKR in ILI', 'knee pain', 'Visual Analog Scale and Western Ontario', 'subsequent TKR incidence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",5125.0,0.0668287,"In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96).","[{'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN; Department of Physical Therapy, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Singhal', 'Affiliation': 'Department of Physical Therapy, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Fridtjof', 'Initials': 'F', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Mihalko', 'Affiliation': 'Department of Biomedical Engineering, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.057']
3057,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3058,31378980,Nutrient supplementation during the first 1000 days and growth of infants born to pregnant adolescents.,"Few studies have evaluated the impact of nutritional supplementation among pregnant adolescents. We examined the effects of the Rang Din Nutrition Study (RDNS) interventions on children born to mothers <20 years of age. The RDNS was a cluster-randomized effectiveness trial with four arms: (1) women and children both received small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control). We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents. Among adolescents, prenatal LNS reduced newborn stunting by 25% and small head size by 28% and had a marginally significant effect on newborn wasting, compared with IFA. Low birth weight and preterm birth were reduced only among adolescents with lower food security. Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control). Initiatives targeting pregnant adolescents in similar settings should consider inclusion of small-quantity LNS, particularly for adolescents living in food-insecure households.",2020,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"['adolescents living in food-insecure households', 'We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents', 'children born to mothers <20 years of age', 'infants born to pregnant adolescents', 'pregnant adolescents']","['Rang Din Nutrition Study (RDNS) interventions', 'Nutrient supplementation', 'small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control']","['Low birth weight and preterm birth', 'subsequent growth status', 'newborn wasting', 'newborn stunting']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",1552.0,0.0901711,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"[{'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}]",Annals of the New York Academy of Sciences,['10.1111/nyas.14191']
3059,32080858,Regenerative potential of cultured gingival fibroblasts in treatment of periodontal intrabony defects (randomized clinical and biochemical trial).,"BACKGROUND


Defective cellular elements constitute an important challenge to achieve predictable periodontal regeneration. In an attempt to improve the cellularity of periodontal defects, gingival fibroblasts were implanted without their associated extracellular elements in periodontal defects to expose them to periodontal tissue mediators. In order to investigate the regenerative potential of gingival fibroblasts translocated into periodontal defects, the present study was designed to clinically and biochemically investigate the use of gingival fibroblasts (GF) and their associated mesenchymal stem cells (GMSC) in the treatment of intrabony periodontal defects.
METHODS


A total of 20 subjects were randomly divided into two groups (n = 20). Group I: ten patients were included with ten intrabony periodontal defects that received β-calcium triphosphate (β-TCP) followed by collagen membrane defect coverage, while group II: (10 patients) ten periodontal defects received cultured gingival fibroblasts (GF) on the β-TCP scaffold and covered by a collagen membrane. The clinical evaluation was carried out at the beginning and at 6 months. Gingival crevicular fluid (GCF) samples were collected directly from the test sites for the quantitative measurement of PDGF-BB and BMP-2 using the ELISA kit at 1, 7, 14, and 21 days after surgery.
RESULTS


Group II reported a significantly greater reduction in vertical pocket depth (VPD) and CAL gain compared with group I after 6 months. Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential. The concept of total isolation of gingival fibroblasts using occlusive membranes must be re-evaluated.",2020,"Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential.","['Group I: ten patients were included with ten intrabony periodontal defects that received', '20 subjects']","['β-calcium triphosphate (β-TCP) followed by collagen membrane defect coverage, while group II: (10 patients) ten periodontal defects received cultured gingival fibroblasts (GF', 'gingival fibroblasts (GF) and their associated mesenchymal stem cells (GMSC', 'cultured gingival fibroblasts']","['PDGF-BB', 'vertical pocket depth (VPD) and CAL gain', 'Radiographic bone gain', 'Gingival crevicular fluid (GCF) samples']","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1960460', 'cui_str': 'Intrabony periodontal defect'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0146894', 'cui_str': 'triphosphate'}, {'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",20.0,0.0208254,"Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential.","[{'ForeName': 'Mahetab', 'Initials': 'M', 'LastName': 'Abdal-Wahab', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Abdel Ghaffar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Ezzatt', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Abdel Aziz', 'Initials': 'AAA', 'LastName': 'Hassan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mervat Mohamed S', 'Initials': 'MMS', 'LastName': 'El Ansary', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Y', 'Initials': 'AY', 'LastName': 'Gamal', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Nahda University, Cairo, Egypt.'}]",Journal of periodontal research,['10.1111/jre.12728']
3060,32061709,Comparison of two different suture knot techniques on postoperative morbidity after impacted mandibular third molar surgery.,"INTRODUCTION


In third molar surgery, one of the most important factors is how the wound was closed. Tight suturing of the wound commonly gives more discomfort to the many patients in terms of postoperative pain, swelling and trismus. The purpose of this study is to investigate the effects of two different knot techniques in suturing after extraction of impacted mandibular third molars (IMTM) on quality of life and postoperative complications such as pain, swelling and trismus.
MATERIAL AND METHODS


This study was conducted with a randomized and split-mouth design and included 50 patients over the age of 18 in the ASA I group who had bilateral horizontal impacted mandibular third molars. In all patients, the wounds were closed by simple sutures by applying two different knot techniques as locked (GroupL, n=50) and unlocked (Group UL, n=50) knots. In the postoperative period, pain, swelling, trismus, chewing activity and quality of life were examined.
RESULTS


In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
CONCLUSION


In preventing postoperative complications that are observed after impacted mandibular third molar surgery and affect the quality of life of patients negatively, suturing of the wound by the method of unlocked knotting is a useful technique that may be preferred.",2020,"In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
","['after impacted mandibular third molar surgery', '50 patients over the age of 18 in the ASA I group who had bilateral horizontal impacted mandibular third molars']","['suture knot techniques', 'knot techniques in suturing after extraction of impacted mandibular third molars (IMTM']","['pain, swelling, trismus, chewing activity and quality of life', 'quality of life and postoperative complications such as pain, swelling and trismus', 'postoperative morbidity', 'quality of life', 'postoperative pain, swelling and trismus']","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",50.0,0.0603259,"In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman 02200, Turkey. Electronic address: miregein@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Najafov', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.02.002']
3061,32086657,Comparing Fidelity Outcomes of Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention.,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression. An ongoing cluster-randomized trial is comparing the effectiveness of the six-session MB group intervention led by paraprofessionals versus mental health professionals. Twenty percent of all audio-recorded intervention sessions were randomly selected for fidelity checks. Analyses assessed mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects. There were no significant differences found between study arms. Findings show paraprofessionals can deliver MB with similar fidelity as mental health professionals.",2020,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression.",['Mothers and Babies (MB'],['Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention'],"['mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0355021,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Diebold', 'Affiliation': 'Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, Suite 643, Chicago, IL, 60611, USA. alicia.diebold@northwestern.edu.'}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, Suite 643, Chicago, IL, 60611, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yeh', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'Jackie K', 'Initials': 'JK', 'LastName': 'Gollan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'S Darius', 'Initials': 'SD', 'LastName': 'Tandon', 'Affiliation': 'Department of Medical Social Sciences, Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01022-5']
3062,31381152,"Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.","BACKGROUND


The current randomized, double-blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy-induced nausea and vomiting in Japanese patients receiving cisplatin-based chemotherapy.
METHODS


Patients scheduled to receive cisplatin (at a dose of ≥70 mg/m 2  )-based regimens were randomly assigned to receive fosnetupitant at a dose of 81 mg or 235 mg or placebo in combination with palonosetron at a dose of 0.75 mg and dexamethasone. The primary endpoint was complete response (CR; no vomiting and no rescue medication) during the overall phase (0-120 hours). The overall CR rate was compared between each dose of fosnetupitant and the placebo group adjusting for the stratification factors of sex and age class (age <55 years vs age ≥55 years). Safety was assessed, with special attention given to events that potentially were suggestive of infusion site reactions.
RESULTS


A total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81-mg and 235-mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group.
CONCLUSIONS


Fosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile.",2019,"The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]).","['194 patients, 195 patients, and 195 patients', 'Patients scheduled to receive', 'Japanese patients receiving cisplatin-based chemotherapy', '594 patients were randomized', 'patients receiving highly emetogenic chemotherapy', 'at a dose of ≥70']","['cisplatin-based chemotherapy', 'placebo in combination with palonosetron at a dose of 0.75\xa0mg and dexamethasone', 'placebo', 'cisplatin', 'palonosetron']","['nausea and vomiting', 'Safety profiles', 'overall CR rate', 'incidence of infusion site reactions', 'complete response (CR; no vomiting and no rescue medication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1096343', 'cui_str': 'Infusion Site Adverse Event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}]",594.0,0.445454,"The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]).","[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Inui', 'Affiliation': 'Respiratory Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kanehara', 'Affiliation': 'Department of Respiratory Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Morise', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Yoshimori', 'Affiliation': 'Department of Clinical Oncology, Fukujuji Hospital, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kumagai', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Fukui', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwashima', 'Affiliation': 'Department of Respiratory Medicine, Nagaoka Chuo General Hospital, Niigata, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Takeda', 'Affiliation': 'Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Saeki', 'Affiliation': 'Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Cancer,['10.1002/cncr.32429']
3063,32061533,"Effect of an education program, risk assessment checklist and prevention protocol on violence against emergency department nurses: A single center before and after study.","AIM


The purpose of this study was to evaluate the effects of an education program, risk assessment checklist and preventive protocol on violence against emergency department nurses.
METHODS


The design was a quasi-experimental before and after study of a group. A hospital emergency department's nurses participated in a workshop in which they were taught a method of using a risk assessment checklist and preventive protocol. The intervention lasted six weeks. The mean score and type of violence was measured before and after the intervention. The data were analyzed by SPSS.
RESULTS


The mean score of violence before the intervention was 8.4 and after the intervention it was 2.7, which was statistically a significant difference (p < 0.0001). In addition, there were significant differences in the mean frequency of verbal abuse (p < 0.0001), assessment of workplace security (p = 0.006), fear of injury (p < 0.02) and type of reaction to violence (p < 0.01) before and after the intervention among the nurses.
CONCLUSIONS


Using the BVC risk assessment checklist and preventive protocol can reduce the experience of violence and verbal abuse, which is the most common form of violence for emergency department nurses. Using this checklist and preventive protocol when patients arrive in emergency departments is recommended.",2020,"In addition, there were significant differences in the mean frequency of verbal abuse (p < 0.0001), assessment of workplace security (p = 0.006), fear of injury (p < 0.02) and type of reaction to violence (p < 0.01) before and after the intervention among the nurses.
",['violence against emergency department nurses'],"['education program, risk assessment checklist and prevention protocol', 'education program, risk assessment checklist and preventive protocol']","['mean frequency of verbal abuse', 'fear of injury', 'workplace security', 'type of reaction to violence', 'mean score and type of violence', 'mean score of violence']","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0558089', 'cui_str': 'Verbally abusive behavior (finding)'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0167301,"In addition, there were significant differences in the mean frequency of verbal abuse (p < 0.0001), assessment of workplace security (p = 0.006), fear of injury (p < 0.02) and type of reaction to violence (p < 0.01) before and after the intervention among the nurses.
","[{'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Sharifi', 'Affiliation': 'Student Research Committee, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Roonak', 'Initials': 'R', 'LastName': 'Shahoei', 'Affiliation': 'Clinical Care Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Nouri', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Almvik', 'Affiliation': 'Centre for Research & Education in Forensic Psychiatry, Forensic Department Bröset, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Valiee', 'Affiliation': 'Clinical Care Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran. Electronic address: valiee@muk.ac.ir.'}]",International emergency nursing,['10.1016/j.ienj.2019.100813']
3064,31668385,Interaction of circulating GLP-1 and the response of the dorsolateral prefrontal cortex to food-cues predicts body weight development.,"OBJECTIVES


This study evaluated the impact of the interaction between the anorexigenic incretin hormone glucagon-like peptide-1 (GLP-1) and reward-related brain activity in the dorsolateral prefrontal cortex (DLPFC), a key area of behavioral control, on future weight loss in obese individuals.
METHODS


We performed a weight loss-weight maintenance intervention study over 27 months. We applied an fMRI food-cue reactivity paradigm during which the participants were passively exposed to food pictures to evaluate neuronal activity in the DLPFC. Additionally, we measured concentrations of circulating GLP-1 levels during a standard oral glucose tolerance test. Phenotyping was performed consecutively before and after a 3-month low-calorie diet as well as after a randomized 12-month trial, investigating the effect of a combined behavioral intervention on body weight maintenance. Participants were then followed-up for another 12 months without further intervention.
RESULTS


Using voxel-wise linear mixed-effects regression analyses, we evaluated 56 measurements and identified a strong interaction between circulating, endogenous GLP-1 levels and DLPFC activity predicting body weight change over the total observation period (t = -6.17, p = 1.6 · 10 -7 ). While neither the GLP-1 nor the DLPFC response individually predicted the subsequent weight change, participants achieved body weight loss when the GLP-1 and the DLPFC responses occurred concurrently.
CONCLUSIONS


Our data demonstrate an interaction between a peripheral hormonal signal and central nervous activity as robust predictor of body weight change throughout the different periods of a long-term life-style intervention. The preeminent role of their interdependency compared to the partly ambivalent effects of the single components argues for integrative approaches to improve sensitivity and reliability of weight prediction conventionally based on individual biomarkers.",2019,"While neither the GLP-1 nor the DLPFC response individually predicted the subsequent weight change, participants achieved body weight loss when the GLP-1 and the DLPFC responses occurred concurrently.
",['obese individuals'],"['combined behavioral intervention', 'anorexigenic incretin hormone glucagon-like peptide-1 (GLP-1) and reward-related brain activity']","['body weight change', 'circulating, endogenous GLP-1 levels and DLPFC activity predicting body weight change', 'body weight loss', 'concentrations of circulating GLP-1 levels', 'body weight maintenance']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4042910', 'cui_str': 'Body Weight Maintenances'}]",,0.0171033,"While neither the GLP-1 nor the DLPFC response individually predicted the subsequent weight change, participants achieved body weight loss when the GLP-1 and the DLPFC responses occurred concurrently.
","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Maurer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Clinic of Endocrinology, Diabetes and Metabolism, Berlin, Germany; Charité - Universitätsmedizin Berlin, Charité Center for Cardiovascular Research, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; Charité - Universitätsmedizin Berlin, DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany. Electronic address: lukas.maurer@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Clinic of Endocrinology, Diabetes and Metabolism, Berlin, Germany; Charité - Universitätsmedizin Berlin, DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Krude', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Clinic of Pediatric Endocrinology and Diabetology, Berlin, Germany.'}, {'ForeName': 'John-Dylan', 'Initials': 'JD', 'LastName': 'Haynes', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Excellence Cluster NeuroCure, Berlin, Germany; Charité - Universitätsmedizin Berlin, Berlin Center for Advanced Neuroimaging, Department of Neurology, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Weygandt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Excellence Cluster NeuroCure, Berlin, Germany; Charité - Universitätsmedizin Berlin, Berlin Center for Advanced Neuroimaging, Department of Neurology, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Clinic of Endocrinology, Diabetes and Metabolism, Berlin, Germany; Charité - Universitätsmedizin Berlin, Charité Center for Cardiovascular Research, Berlin, Germany; Charité - Universitätsmedizin Berlin, DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}]",Molecular metabolism,['10.1016/j.molmet.2019.08.014']
3065,30785198,"Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial.","BACKGROUND


Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of XELOX versus GEMOX as first-line therapy for advanced BCTs.
PATIENTS AND METHODS


In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000 mg/m2 on days 1 and 8, and oxaliplatin 100 mg/m2 on day 1) or XELOX (capecitabine 1000 mg/m2, twice daily, on days 1-14 and oxaliplatin 130 mg/m2 on day 1) as first-line treatment, given every 3 weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate.
RESULTS


In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3 months for the GEMOX group and 5.8 months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was -12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
CONCLUSION


XELOX showed significant noninferiority to GEMOX in terms of 6-month PFS rate. Thus, XELOX could be an alternative first-line treatment of BCTs.
TRIAL REGISTRATION


This study was registered in ClinicalTrials.gov (number NCT01470443).",2019,"The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
","['randomly selected patients with metastatic BCTs to receive', '114 patients randomly received', 'advanced biliary tract cancers']","['Capecitabine plus oxaliplatin (XELOX', 'XELOX', 'oxaliplatin 130', 'GEMOX', 'XELOX versus GEMOX', 'Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin', 'GEMOX (gemcitabine 1000\u2009mg/m2 on days 1 and 8, and oxaliplatin 100\u2009mg/m2 on day 1) or XELOX (capecitabine', 'Meanwhile, gemcitabine plus oxaliplatin (GEMOX']","['frequencies of hospital visits', 'activity and tolerable toxicity', '6-month PFS rate', '6-month PFS rate difference', '6-month progression-free survival (PFS) rate', 'median overall survival', 'median PFS', 'objective response', 'neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4081033', 'cui_str': 'oxaliplatin 100 MG'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",114.0,0.0918181,"The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Gyeongsang National University Hospital, Jinju.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Ajou University School of Medicine, Suwon.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Dong-A University School of Medicine, Busan.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Chung-Ang University College of Medicine, Seoul.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': ""Division of Hemato-oncology, Department of Medicine, Seoul St Mary's Hospital, Catholic University, Seoul.""}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Sohn', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Konkuk University Medical Center, Seoul.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Yonsei University College of Medicine, Seoul.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': ""Division of Hemato-oncology, Department of Medicine, Incheon St Mary's Hospital, Catholic University, Incheon.""}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul. Electronic address: oncopark@skku.edu.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul. Electronic address: hoylim@skku.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz058']
3066,32076105,Noninvasive neuromodulation of the prefrontal cortex in young women with obesity: a randomized clinical trial.,"BACKGROUND/OBJECTIVES


Obesity is associated with reduced neurocognitive performance. Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior. Transcranial direct current stimulation (tDCS) has emerged as a potential technique to correct these abnormalities. However, there is limited information to date, particularly in clinical settings and regarding long-term effects of tDCS. This study aimed to investigate the effects of DLPFC-targeted tDCS in young women with obesity.
SUBJECT/METHODS


Randomized, double-blind, sham-controlled parallel-design clinical trial conducted in 38 women, aged 20-40 years, with BMI 30-35 kg/m 2 .
STUDY DESIGN


Phase I: target engagement (immediate effects of tDCS on working memory performance), Phase II: tDCS only (ten sessions, 2 weeks), Phase III: tDCS + hypocaloric diet (six sessions, 30% energy intake reduction, 2 weeks, inpatient), Phase IV: follow-up at 1, 3, and 6 months.
PRIMARY OUTCOME


change in body weight.
SECONDARY OUTCOMES


change in eating behavior and appetite. Additional analyses: effect of Catechol-O-methyl transferase (COMT) gene variability. Data were analyzed as linear mixed models.
RESULTS


There was no group difference in change in body weight during the tDCS intervention. At follow-up, the active group lost less weight than the sham group. In addition, the active group regained weight at 6-month follow-up, compared with sham. Genetic analysis indicated that COMT Met noncarriers were the subgroup that accounted for this paradoxical response in the active group.
CONCLUSION


Our results suggest that in young women with class I obesity, tDCS targeted to the DLPFC does not facilitate weight loss. Indeed, we found indications that tDCS could have a paradoxical effect in this population, possibly connected with individual differences in dopamine availability. Future studies are needed to confirm these findings.",2020,"Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior.","['young women with obesity', '38 women, aged 20-40 years, with BMI 30-35\u2009kg/m 2 ', 'young women with class I obesity', 'Individuals with obesity']","['Transcranial direct current stimulation (tDCS', 'DLPFC-targeted tDCS', 'tDCS', 'Catechol-O-methyl transferase (COMT', 'tDCS\u2009+\u2009hypocaloric diet']","['body weight', 'eating behavior and appetite', 'working memory performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007413', 'cui_str': 'o-Dihydroxybenzenes'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0474423', 'cui_str': 'Eating behavior and appetite (finding)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",38.0,0.208513,"Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior.","[{'ForeName': 'Priscila Giacomo', 'Initials': 'PG', 'LastName': 'Fassini', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Energy Metabolism Laboratory, Jean Mayer USDA Human Nutrition Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111-1524, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Júlio Sérgio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Wilson Araújo', 'Initials': 'WA', 'LastName': 'da Silva Junior', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Isabela Rozatte', 'Initials': 'IR', 'LastName': 'da Silva', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Rafaella', 'Initials': 'R', 'LastName': 'de Souza Ribeiro Salgueiro', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Cássia Dias', 'Initials': 'CD', 'LastName': 'Machado', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Vivian Marques Miguel', 'Initials': 'VMM', 'LastName': 'Suen', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA. migalonsoalonso@alumni.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-020-0545-3']
3067,32078337,Reducing training frequency from 3 or 4 sessions/week to 2 sessions/week does not attenuate improvements in maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT).,"In the present randomised-controlled trial we investigated the effect of reduced-exertion high-intensity interval training (REHIT) training frequency (2, 3, or 4 sessions/week for 6 weeks) on maximal aerobic capacity in 42 inactive individuals (13 women; mean ± SD age: 25 ± 5 years, maximal aerobic capacity: 35 ± 5 mL·kg -1 ·min -1 ). Changes in maximal aerobic capacity were not significantly different between the 3 groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%). In conclusion, a training frequency of 2 sessions/week is sufficient for REHIT to improve maximal aerobic capacity.  Novelty  We demonstrate that reducing REHIT training frequency from 3 or 4 to 2 sessions/week does not attenuate improvements in the key health marker of maximal aerobic capacity.",2020,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"['42 inactive individuals (13 women; mean±SD age: 25±5 y, V̇O2max: 35±5 mL·kg-1·min-1']",['REHIT training frequency'],"['maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT', 'maximal aerobic capacity (V̇O2max', 'Changes in V̇O2max', 'Novelty']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",42.0,0.0158426,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Preeyaphorn', 'Initials': 'P', 'LastName': 'Songsorn', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Gorman', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Brackenridge', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cullen', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Fitzpatrick', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Niels B J', 'Initials': 'NBJ', 'LastName': 'Vollaard', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0750']
3068,31372757,"Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.","Postpartum depression (PPD) is a common complication following delivery, though evidence-based treatment options are limited. This study explores the feasibility and efficacy of outpatient PPD treatment with transdermal estradiol (TE). In a pilot, double-blind, placebo-controlled trial, women with PPD were randomized to receive transdermal 17β-estradiol (100 mcg/day) or placebo patch. Over 6 weeks, women completed weekly ratings on the Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D). Primary outcome measures were treatment response (> 50% decrease from baseline BDI) and remission (BDI < 10) at 6 weeks, and secondary outcome measures included severity on all scales at weeks 3 and 6. Of 12 recruited women, 6 received TE and 6 received placebo. By week 6, 5 women receiving TE responded to treatment and 4 showed symptom remission, compared to 2 responders and 1 remitter in the placebo group. This difference was not significant (p = 0.24). In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction. Analogous effects were found for HAM-D but not EPDS scores. Interestingly, no significant difference in plasma estradiol levels existed between groups. We were unable to demonstrate a significant therapeutic benefit of TE compared with placebo in PPD. Although limited by under-recruitment and loss to follow-up, our results suggest TE is a feasible option for outpatient PPD management, with preliminary evidence (based on secondary outcomes) for efficacy. Therapeutic effects may be seen as early as 3 weeks and may not directly depend on peripheral measures of estradiol.",2020,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","['Of 12 recruited women, 6 received TE and 6 received', 'postpartum depression', 'women with PPD']","['Transdermal estradiol', 'placebo', 'placebo patch', 'transdermal 17β-estradiol', 'outpatient PPD treatment with transdermal estradiol (TE']","['plasma estradiol levels', 'Postpartum depression (PPD', 'symptom remission', 'treatment response (>\u200950% decrease from baseline BDI) and remission', 'Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1277973', 'cui_str': 'Plasma estradiol measurement'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]",12.0,0.768545,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","[{'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Martinez', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Epidemiology, National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Schenkel', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lynnette K', 'Initials': 'LK', 'LastName': 'Nieman', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schmidt', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. PeterSchmidt@mail.nih.gov.'}]",Archives of women's mental health,['10.1007/s00737-019-00991-3']
3069,31522218,Does sugammadex decrease the severity of agitation and complications in pediatric patients undergoing adenotonsillectomy?,"OBJECTIVES


To evaluate  the effectiveness of sugammadex in reducing or eliminating postoperative agitation levels, early respiratory complications and nausea/vomiting in children undergoing adenotonsillectomy.
METHODS


A total of 70 patients (age range: 5-13 years) who underwent an adenotonsillectomy  in the Otolaryngology Clinic, Sakarya University, Sakarya, Turkey between May 2015 and September 2017 were included in the study. The patients were randomized into a sugammadex group (Group S) and a neostigmine + atropine (Group N); each group contained 35 patients. Time to extubation, postoperative agitation levels, and early postoperative complications were evaluated and recorded. Data from both groups were statistically evaluated and compared.
RESULTS


The time to extubation was significantly shorter in Group S than Group N (p less than 0.05). Agitation scores during recovery were significantly lower in Group S than Group N (p less than 0.05). More complications were observed in Group N than in Group S; the number of patients seen coughing and experiencing nausea/vomiting in Group S was statistically significantly lower (p less than 0.05).
CONCLUSION


This study demonstrated that the use of sugammadex results in less time to recovery and less agitation in comparison to conventional administration of neostigmine + atropine in the reversal of neuromuscular blocking after adenotonsillectomy.",2019,The time to extubation was significantly shorter in Group S than Group N (p less than 0.05).,"['pediatric patients undergoing', 'children undergoing adenotonsillectomy', '70 patients (age range: 5-13 years) who underwent an adenotonsillectomy\xa0 in the Otolaryngology Clinic, Sakarya University, Sakarya, Turkey between May 2015 and September 2017 were included in the study']","['adenotonsillectomy', 'sugammadex', 'neostigmine + atropine']","['Agitation scores', 'More complications', 'severity of agitation and complications', 'time to extubation', 'Time to extubation, postoperative agitation levels, and early postoperative complications', 'number of patients seen coughing and experiencing nausea/vomiting', 'nausea/vomiting']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",2017.0,0.0998475,The time to extubation was significantly shorter in Group S than Group N (p less than 0.05).,"[{'ForeName': 'Muge O', 'Initials': 'MO', 'LastName': 'Korkmaz', 'Affiliation': 'Otolaryngology Department, Sakarya University, Sakarya, Turkey. E-mail. ozcelikmuge@gmail.com.'}, {'ForeName': 'Havva', 'Initials': 'H', 'LastName': 'Sayhan', 'Affiliation': ''}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Guven', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2019.9.24485']
3070,31359374,Evaluating the Effect of a Video Education Curriculum for First Time Breast Cancer Patients: a Prospective RCT Feasibility Study.,"Newly diagnosed breast cancer patients seek information through a variety of sources. In this small pilot study, we evaluated the feasibility of providing personalizable breast cancer video education prior to the first oncology consultation and compared outcomes to patients receiving standard of care educational materials. Personalized videos included detailed information on a patient's specific grade, stage, and tumor subtype (e.g., grade 2, stage 3, triple negative breast cancer) in addition to general videos that defined the terms of grade, stage, and cancer subtype. Newly diagnosed breast cancer patients who were scheduled for an initial oncology appointment at two sites were enrolled in this prospective, randomized control trial. Twenty-eight patients were assigned to receive either video education (experimental group) with the possibility of personalization or a video explaining how to view cancer education materials at the cancer center website (control group). Sixteen oncologists at the two centers also participated in evaluating patient outcomes. Pre- and post-education surveys queried patient-perceived understanding of breast cancer and treatment, perceived ability for decision-making, confidence in providers, and anxiety and depression symptoms. We observed that patients given video education had greater improvements in some of these areas, with the biggest improvement seen in patients who received a personalized video on their specific tumor subtype (based on tumor receptor status). Overall, however, there were no statistically significant differences between the study groups. We conclude that providing personalized video education during the time prior to first oncologic consultation is feasible and may provide benefit for patients, especially for explaining complex components of a diagnosis, such as a cancer subtype. Further research is needed to determine how to optimally provide education tailored to a given patient and tumor type, and how to leverage patients' electronic devices as an education delivery vehicle.",2019,"Overall, however, there were no statistically significant differences between the study groups.","['Newly diagnosed breast cancer patients who were scheduled for an initial oncology appointment at two sites', 'Sixteen oncologists at the two centers also participated in evaluating patient outcomes', 'patients receiving standard of care educational materials', 'Newly diagnosed breast cancer patients', 'Twenty-eight patients', 'First Time Breast Cancer Patients']","['video education (experimental group) with the possibility of personalization or a video explaining how to view cancer education materials at the cancer center website (control group', 'personalizable breast cancer video education', 'Video Education Curriculum', 'personalized video']","['breast cancer and treatment, perceived ability for decision-making, confidence in providers, and anxiety and depression symptoms']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0554794', 'cui_str': 'Cancer education'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",28.0,0.035516,"Overall, however, there were no statistically significant differences between the study groups.","[{'ForeName': 'Nika', 'Initials': 'N', 'LastName': 'Sulakvelidze', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA. nsulakvelidze@gmail.com.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Burdick', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kaklamani', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Texas Health Science Center - San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tilton', 'Affiliation': 'Division of Breast Oncology, Seattle Cancer Care Alliance, Seattle, WA, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Javid', 'Affiliation': 'Department of Surgery, Division of Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01578-3']
3071,31362799,"Multiple mediation analysis of the peer-delivered Thinking Healthy Programme for perinatal depression: findings from two parallel, randomised controlled trials.","BACKGROUND


Low-intensity psychosocial interventions have been effective in targeting perinatal depression, but relevant mechanisms of change remain unknown.AimsTo examine three theoretically informed mediators of the Thinking Healthy Programme Peer-delivered (THPP), an evidence-based psychosocial intervention for perinatal depression, on symptom severity in two parallel, randomised controlled trials in Goa, India and Rawalpindi, Pakistan.
METHOD


Participants included pregnant women aged ≥18 years with moderate to severe depression, as defined by a Patient Health Questionnaire 9 (PHQ-9) score ≥10, and were randomised to either THPP or enhanced usual care. We examine whether three prespecified variables (patient activation, social support and mother-child attachment) at 3 months post-childbirth mediated the effects of THPP interventions of perinatal depressive symptom severity (PHQ-9) at the primary end-point of 6 months post-childbirth. We first examined individual mediation within each trial (n = 280 in India and n = 570 in Pakistan), followed by a pooled analysis across both trials (N = 850).
RESULTS


In both site-specific and pooled analyses, patient activation and support at 3 months independently mediated the intervention effects on depressive symptom severity at 6 months, accounting for 23.6 and 18.2% of the total effect of THPP, respectively. The intervention had no effect on mother-child attachment scores, thus there was no evidence that this factor mediated the intervention effect.
CONCLUSIONS


The effects of the psychosocial intervention on depression outcomes in mothers were mediated by the same two factors in both contexts, suggesting that such interventions seeking to alleviate perinatal depression should target both social support and patient activation levels.Declaration of interestNone.",2019,"The intervention had no effect on mother-child attachment scores, thus there was no evidence that this factor mediated the intervention effect.
","['Participants included pregnant women aged ≥18 years with moderate to severe depression, as defined by a Patient Health Questionnaire 9 (PHQ-9) score ≥10', 'perinatal depression']","['THPP or enhanced usual care', 'peer-delivered Thinking Healthy Programme', 'Thinking Healthy Programme Peer-delivered (THPP), an evidence-based psychosocial intervention', 'psychosocial intervention']","['perinatal depressive symptom severity (PHQ-9', 'mother-child attachment scores', 'depression outcomes', 'depressive symptom severity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}]","[{'cui': 'C0060462', 'cui_str': 'flopropione'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",850.0,0.112113,"The intervention had no effect on mother-child attachment scores, thus there was no evidence that this factor mediated the intervention effect.
","[{'ForeName': 'Daisy R', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Assistant Professor and Clinician Scientist, Department of Psychiatry,Sinai Health System,University of Toronto,Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'MacKinnon', 'Affiliation': 'Professor, Department of Psychology,Arizona State University,USA.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Assistant Professor, Department of Health Services Research and Policy,London School of Hygiene and Tropical Medicine,UK.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Assistant Professor, Health Services Academy, Pakistan; and Human Development Research Foundation,Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Professor, Institute of Psychology Health and Society,University of Liverpool,UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Professor, Sangath, India;Department of Global Health and Social Medicine,Harvard Medical School; andDepartment of Global Health and Population,Harvard TH Chan School of Public Health,Massachusetts,USA.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.184']
3072,31364232,Glucagon-like peptide-2 mobilizes lipids from the intestine by a systemic nitric oxide-independent mechanism.,"AIM


To test the hypothesis that gut hormone glucagon-like peptide-2 (GLP-2) mobilizes intestinal triglyceride (TG) stores and stimulates chylomicron secretion by a nitric oxide (NO)-dependent mechanism in humans.
METHODS


In a randomized, single-blind, cross-over study, 10 healthy male volunteers ingested a high-fat formula followed, 7 hours later, by one of three treatments: NO synthase inhibitor L-N G  -monomethyl arginine acetate (L-NMMA) + GLP-2 analogue teduglutide, normal saline + teduglutide, or L-NMMA + placebo. TG in plasma and lipoprotein fractions were measured, along with measurement of blood flow in superior mesenteric and coeliac arteries using Doppler ultrasound in six participants.
RESULTS


Teduglutide rapidly increased mesenteric blood flow and TG concentrations in plasma, in TG-rich lipoproteins, and most robustly in chylomicrons. L-NMMA significantly attenuated teduglutide-induced enhancement of mesenteric blood flow but not TG mobilization and chylomicron secretion.
CONCLUSIONS


GLP-2 mobilization of TG stores and stimulation of chylomicron secretion from the small intestine appears to be independent of systemic NO in humans.",2019,"L-NMMA significantly attenuated teduglutide-induced enhancement of mesenteric blood flow but not TG mobilization and chylomicron secretion.
","['10 healthy male volunteers ingested a high-fat formula followed, 7 hours later, by one of three treatments']","['NO synthase inhibitor L-N G  -monomethyl arginine acetate (L-NMMA)\u2009+\u2009GLP-2 analogue teduglutide, normal saline + teduglutide, or L-NMMA + placebo', 'gut hormone glucagon-like peptide-2 (GLP-2) mobilizes intestinal triglyceride (TG) stores']","['mesenteric blood flow and TG concentrations in plasma, in TG-rich lipoproteins', 'mesenteric blood flow', 'TG in plasma and lipoprotein fractions']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0912332', 'cui_str': 'Proglucagon (126-158)'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0025474', 'cui_str': 'Mesentery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",10.0,0.110688,"L-NMMA significantly attenuated teduglutide-induced enhancement of mesenteric blood flow but not TG mobilization and chylomicron secretion.
","[{'ForeName': 'Changting', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Stahel', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Morgantini', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Nahmias', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Dash', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gary F', 'Initials': 'GF', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Endocrinology and Metabolism, Banting and Best Diabetes Centre, University of Toronto, Toronto, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13839']
3073,31359842,Instruction Modes for Motor Control Skills Acquisition: A Randomized Controlled Trial.,"The objective was to compare two different instruction modes used to teach patients with nonspecific chronic low back pain (CLBP) to perform a lumbar motor control task. The three intervention instruction modes used were: common verbal explanation of a motor task based on a motor control therapeutic exercise (MCTE-control group), MTCE instructed using motor imagery (MI) and MCTE instructed using tactile feedback (TF). The main outcome measure was lumbar motor control of the neutral position test. Forty-eight patients with CLBP were randomly allocated into three groups of 16 patients per group. The MI strategy was the most effective mode for developing the motor control task in an accurate and controlled manner, obtaining better outcomes than TF or verbal instruction.",2020,"The MI strategy was the most effective mode for developing the motor control task in an accurate and controlled manner, obtaining better outcomes than TF or verbal instruction.","['patients with nonspecific chronic low back pain (CLBP', 'Forty-eight patients with CLBP', 'Motor Control Skills Acquisition']","['lumbar motor control task', 'common verbal explanation of a motor task based on a motor control therapeutic exercise (MCTE-control group), MTCE instructed using motor imagery (MI) and MCTE instructed using tactile feedback (TF']",['lumbar motor control of the neutral position test'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",48.0,0.0214448,"The MI strategy was the most effective mode for developing the motor control task in an accurate and controlled manner, obtaining better outcomes than TF or verbal instruction.","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Sánchez-Vázquez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Prieto-Aldana', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Navarro-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}]",Journal of motor behavior,['10.1080/00222895.2019.1645087']
3074,31823654,ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer.,"Immune checkpoint inhibitors have revolutionized the treatment of patients with metastatic urothelial carcinoma. In cisplatin-eligible muscle-invasive bladder cancer (MIBC), cisplatin-based neoadjuvant chemotherapy (NAC) before radical cystectomy improves overall survival. Tumor PD-L1 expression increases in MIBC after NAC, suggesting potential synergy in combining PD1/PD-L1 inhibitors with NAC. IDO1 is overexpressed in bladder cancer and is associated with poor outcomes. Linrodostat mesylate (BMS-986205) - a selective, potent, oral IDO1 inhibitor - combined with nivolumab has demonstrated safety and preliminary evidence of clinical activity in metastatic urothelial carcinoma. Here, we discuss the rationale and trial design of the ENERGIZE, a Phase III trial investigating the efficacy of NAC in combination with nivolumab with or without linrodostat followed by postsurgery nivolumab or nivolumab with linrodostat in cisplatin-eligible patients with MIBC. Clinical trial registration number: NCT03661320.",2020,"Tumor PD-L1 expression increases in MIBC after NAC, suggesting potential synergy in combining PD1/PD-L1 inhibitors with NAC.","['muscle-invasive bladder cancer', 'patients with metastatic urothelial carcinoma', 'metastatic urothelial carcinoma', 'eligible patients with MIBC']","['nivolumab with or without linrodostat followed by postsurgery nivolumab or nivolumab with linrodostat in cisplatin', 'cisplatin-eligible muscle-invasive bladder cancer (MIBC), cisplatin-based neoadjuvant chemotherapy (NAC) before radical cystectomy', 'Linrodostat mesylate (BMS-986205) - a selective, potent, oral IDO1 inhibitor - combined with nivolumab', 'neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate', 'ENERGIZE', 'NAC']",['overall survival'],"[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.100147,"Tumor PD-L1 expression increases in MIBC after NAC, suggesting potential synergy in combining PD1/PD-L1 inhibitors with NAC.","[{'ForeName': 'Guru', 'Initials': 'G', 'LastName': 'Sonpavde', 'Affiliation': 'Dana-Farber Cancer Institute, Genitourinary Oncology Division, Boston, MA 02215, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Steinberg', 'Affiliation': 'Department of Urology NYU Langone Health, New York University, New York, NY 10017, USA.'}, {'ForeName': 'Juergen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michiel Simon', 'Initials': 'MS', 'LastName': 'Van Der Heijden', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Garzon', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Raybold', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liaw', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rutstein', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Matt D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY 10029, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0611']
3075,32064716,Efficacy of the photon-initiated photoacoustic streaming combined with different solutions on Enterococcus faecalis in the root canals.,"This study aimed to evaluate the efficacy of different irrigation solutions used in photon-initiated photoacoustic streaming (PIPS) or conventional needle irrigation (CNI) for eradication of Enterococcus faecalis from artificial root canals. Altogether, 240 artificial root canal samples were included. The models were split and incubated for 2 days to allow formation of E. faecalis biofilm. The models were randomly divided into two groups (n = 120): CNI and laser-activated irrigation (LAI). Each group was divided into six subgroups according to different irrigation solutions: distilled water, 1% sodium hypochlorite (NaOCl), 2% NaOCl, 5.25% NaOCl, MTAD, and chlorhexidine, respectively. After irrigation, half of the samples (n = 10) were assessed immediately, and the other half of the samples (n = 10) were incubated for 6 hr. Bacterial suspensions were obtained from all samples before and after irrigation, and after incubation, and were quantified adenosine 5'-triphosphate (ATP) assay kit. The biofilms were examined using fluorescent microscopy and analyzed by Image Pro Plus software. Significant reduction of ATP, average fluorescence density after irrigation, and growth after incubation was obtained in LAI group than in CNI group (p < .05). LAI can improve bacteriostasis effect of 2% NaOCl (p < .05). PIPS improved the antibacterial effect of the 2% NaOCl used in root canal therapy.",2020,LAI can improve bacteriostasis effect of 2% NaOCl (p < .05).,"['Enterococcus faecalis from artificial root canals', '240 artificial root canal samples were included']","['photon-initiated photoacoustic streaming (PIPS) or conventional needle irrigation (CNI', 'irrigation solutions: distilled water, 1% sodium hypochlorite (NaOCl), 2% NaOCl, 5.25% NaOCl, MTAD, and chlorhexidine', 'photon-initiated photoacoustic streaming combined with different solutions', 'CNI and laser-activated irrigation (LAI']","['ATP, average fluorescence density after irrigation, and growth after incubation', 'antibacterial effect', 'bacteriostasis effect']","[{'cui': 'C0038404', 'cui_str': 'Enterococcus faecalis'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443021', 'cui_str': 'Lai (qualifier value)'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",10.0,0.0139245,LAI can improve bacteriostasis effect of 2% NaOCl (p < .05).,"[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Human Biology Program, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Qianzhou', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Oral Medicine, Guangzhou Institute of Oral Disease, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}]",Microscopy research and technique,['10.1002/jemt.23455']
3076,32057716,Rationale and protocol for a randomized controlled trial comparing daily calorie restriction versus intermittent fasting to improve glycaemia in individuals at increased risk of developing type 2 diabetes.,"BACKGROUND


Intermittent fasting (IF) is proposed as a viable alternative to moderate calorie restriction (CR) for weight loss and metabolic health, but few long term randomized trials have been conducted. This protocol paper describes the rationale and detailed protocol for DIRECT study (Daily versus Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk), comparing long term effectiveness of IF versus CR on metabolic health in individuals who are at increased risk of developing type 2 diabetes.
METHODS


Anticipated 260 non-diabetic men and women aged 35-75 years, BMI 25-50 kg/m 2  with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator will be recruited into this open-label, multi-arm, parallel group sequential randomized controlled trial. Participants will be randomized to one of three groups for 18 months: IF (30% of energy needs on fast days), CR (70% of energy needs daily), or standard care (SC) group. All participants will visit the clinic fortnightly for weight assessments during active intervention phase (6 months), followed by a 12-month follow-up phase. IF and CR groups will receive further diet counselling by dietitian. Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization. Secondary outcomes include changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application.
DISCUSSION


This study will provide substantial evidence as to whether IF is an effective nutrition intervention for glycaemic control in a population at risk of developing type 2 diabetes.",2020,Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization.,"['individuals at increased risk of developing type 2 diabetes', '260 non-diabetic men and women aged 35-75 years, BMI 25-50 kg/m 2  with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator', 'individuals who are at increased risk of developing type 2 diabetes']",['daily calorie restriction'],"['changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC', 'changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",260.0,0.143915,Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization.,"[{'ForeName': 'Xiao Tong', 'Initials': 'XT', 'LastName': 'Teong', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vincent', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia. Electronic address: leonie.heilbronn@adelaide.edu.au.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.01.005']
3077,31094798,Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial.,"BACKGROUND


Tracheal intubation failure in patients with difficult airway is still not uncommon. While videolaryngoscopes such as the Glidescope offer better glottic vision due to an acute-angled blade, this advantage does not always lead to an increased success rate because successful insertion of the tube through the vocal cords may be the limiting factor. We hypothesize that combined use of Glidescope and fiberscope used only as a dynamic guide facilitates tracheal intubation compared to a conventional Glidescope technique with a preshaped nondynamic stylet.
METHODS


One hundred sixty adult patients with predicted difficult airway were randomly assigned to a conventional Glidescope (standard Glidescope group) or a combined Glidescope + fiberscope group intubation. In the Glidescope + fiberscope group under direct vision from the Glidescope, tracheal intubation was performed using the fiberscope as a guide without using fiberoptic vision, while in the standard Glidescope group, a conventional stylet-guided intubation technique was performed. We evaluated the rate of tracheal intubation success at first attempt as the primary end point (Fisher exact test). The difference between groups in airway injury, time to successful intubation, and the need for an alternative technique was also evaluated.
RESULTS


First-attempt intubation success was higher in the Glidescope + fiberscope group than in the standard Glidescope group (91% vs 67%; P = .0012; fragility index, 8; absolute risk reduction, 24% [95% CI, 12%-36%]). Median time to successful tracheal intubation was shorter in the Glidescope + fiberscope group (50 vs 64 seconds; P = .035). Airway injury rate was lower in the Glidescope + fiberscope group than in the standard Glidescope group (1% vs 11%; P = .035; fragility index, 1; absolute risk reduction, 10% [95% CI, 3%-18%]). Alternative rescue technique requirements to achieve tracheal intubation were higher in the standard Glidescope group (24% vs 4%; P < .001; fragility index, 7).
CONCLUSIONS


The use of a dynamic, flexible guide during a Glidescope laryngoscopy in patients with a predicted difficult airway compared to a standard intubation technique improves first-attempt intubation success, decreases the incidence of airway injury and time to successful intubation, as well as the need of an alternative technique to succeed.",2019,"RESULTS


First-attempt intubation success was higher in the Glidescope + fiberscope group than in the standard Glidescope group (91% vs 67%; P = .0012; fragility index, 8; absolute risk reduction, 24% [95% CI, 12%-36%]).",['One hundred sixty adult patients with predicted difficult airway'],"['conventional Glidescope (standard Glidescope group) or a combined Glidescope + fiberscope group intubation', 'Dynamic Versus Stylet-Guided Intubation', 'Glidescope Laryngoscopy']","['Airway injury rate', 'Median time to successful tracheal intubation', 'rate of tracheal intubation success', 'Alternative rescue technique requirements to achieve tracheal intubation', 'First-attempt intubation success', 'airway injury, time to successful intubation, and the need for an alternative technique']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0183663', 'cui_str': 'Stylet, device (physical object)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",160.0,0.0494961,"RESULTS


First-attempt intubation success was higher in the Glidescope + fiberscope group than in the standard Glidescope group (91% vs 67%; P = .0012; fragility index, 8; absolute risk reduction, 24% [95% CI, 12%-36%]).","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Mazzinari', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Rovira', 'Affiliation': 'Research Group in Perioperative Medicine, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Henao', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ortega', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Casasempere', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Fernandez', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, Consorcio Hospital General Universitario, Valencia, Spain.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Belaouchi', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Esparza-Miñana', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Hospital de Manises, Valencia, Spain.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004102']
3078,30778518,A Case for Promoting Movement Medicine: Preventing Disability in the LIFE Randomized Controlled Trial.,"BACKGROUND


The movement profile of older adults with compromised function is unknown, as is the relationship between these profiles and the development of major mobility disability (MMD)-a critical clinical outcome. We first describe the dimensions of movement in older adults with compromised function and then examine whether these dimensions predict the onset of MMD.
METHODS


Older adults at risk for MMD (N = 1,022, mean age = 78.7 years) were randomized to receive a structured physical activity intervention or health education control. We assessed MMD in 6-month intervals (average follow-up of 2.2 years until incident MMD), with activity assessed at baseline, 6-, 12- and 24-month follow-up via accelerometry.
RESULTS


A principal components analysis of 11 accelerometer-derived metrics yielded three components representing lifestyle movement (LM), extended bouts of moderate-to-vigorous physical activity (MVPA), and stationary body posture. LM accounted for the greatest proportion of variance in movement (53%). Within health education, both baseline LM (HR = 0.74; 95% CI 0.62 to 0.88) and moderate-to-vigorous physical activity (HR = 0.69; 95% CI 0.54 to 0.87) were associated with MMD, whereas only LM was associated with MMD within physical activity (HR = 0.74; 95% CI 0.61 to 0.89). There were similar nonlinear relationships present for LM in both physical activity and health education (p < .04), whereby risk for MMD was lower among individuals with higher levels of LM.
CONCLUSIONS


Both LM and moderate-to-vigorous physical activity should be central in treatment regimens for older adults at risk for MMD.
TRIAL REGISTRATION


clinicaltrials.gov Identifier NCT01072500.",2019,"Within HE, both baseline LM (HR=0.74; 95% CI 0.62-0.88) and MVPA (HR=0.69; 95% CI 0.54-0.87) were associated with MMD, while only LM was associated with MMD within PA (HR=0.74; 95% CI 0.61-0.89).","['older adults at risk for MMD', 'older adults with compromised function', 'Older adults at risk for MMD (N=1,022, mean age=78.7', 'older adults']","['11 accelerometer-derived metrics yielded three components representing lifestyle movement (LM), extended bouts of moderate to vigorous physical activity (MVPA), and stationary body posture', 'structured physical activity (PA) intervention or health education control (HE', 'LM and MVPA', 'LM']","['risk for MMD', 'MVPA']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.114822,"Within HE, both baseline LM (HR=0.74; 95% CI 0.62-0.88) and MVPA (HR=0.69; 95% CI 0.54-0.87) were associated with MMD, while only LM was associated with MMD within PA (HR=0.74; 95% CI 0.61-0.89).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Shyh-Huei', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of internal medicine, section on gerontology and geriatric medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Axtell', 'Affiliation': 'Department of Exercise Science, Southern Connecticut State University, New Haven.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Nutrition, Exercise Physiology and Sarcopenia Laboratory, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of epidemiology, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research and Policy and Stanford Prevention Research Center, Palo Alto, California.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Devision of General Internal medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department Epidemiology and Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz050']
3079,32033546,"The reduction in anemia through normative innovations (RANI) project: study protocol for a cluster randomized controlled trial in Odisha, India.","BACKGROUND


More than half of women in India are anemic. Anemia can result in fatigue, poor work productivity, higher risk of pre-term delivery, and maternal mortality. The Indian government has promoted the use of iron-folic acid supplements (IFA) for the prevention and treatment of anemia for the past five decades, but uptake remains low and anemia prevalence high. Current programs target individual-level barriers among pregnant women and adolescents, but a more comprehensive approach that targets multiple levels among all women of reproductive age is needed to increase uptake of IFA and iron-rich foods.
METHODS


The Reduction in Anemia through Normative Innovations (RANI) project is a norms-based intervention to reduce anemia among women of reproductive age. We will evaluate the intervention through a clustered randomized controlled trial in Odisha, India. We will collect data at three time points (baseline, midline, and end line). For the study, we selected 89 clusters of villages, which we randomized into treatment and control on a 1:1 basis. The treatment arm will receive the RANI project components while the control arm will receive usual care. Fifteen clusters (40-41 villages) were selected and 4000 women (2000 in each arm) living in the selected clusters will be randomly selected to take part in data collection. Women in both study arms will have their hemoglobin concentrations measured. They will also complete in-person surveys about their knowledge, attitudes, perceptions of iron folic acid supplements, and nutritional intake. We will also select a smaller cohort of 300 non-pregnant women (150 in each arm) from this cohort for additional physical activity and cognitive testing. We will conduct both within- and between-group comparisons (treatment and control) at baseline, midline and end line using t-tests. We will also conduct structural equation modeling to examine how much each factor accounts for IFA use and hemoglobin levels.
DISCUSSION


This RCT will enable us to examine whether a social norms-based intervention can increase uptake of iron folic acid supplements and iron rich foods to reduce anemia.
TRIAL REGISTRATION


This trial was registered with Clinical Trial Registry- India (CTRI) (CTRI/2018/10/016186) on 29 October 2018.",2020,"METHODS


The Reduction in Anemia through Normative Innovations (RANI) project is a norms-based intervention to reduce anemia among women of reproductive age.","['Fifteen clusters (40-41 villages) were selected and 4000 women (2000 in each arm) living in the selected clusters', 'pregnant women and adolescents', '29 October 2018', 'women of reproductive age', 'smaller cohort of 300 non-pregnant women (150 in each arm) from this cohort for additional physical activity and cognitive testing']",[],"['fatigue, poor work productivity, higher risk of pre-term delivery, and maternal mortality']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],"[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}]",,0.205212,"METHODS


The Reduction in Anemia through Normative Innovations (RANI) project is a norms-based intervention to reduce anemia among women of reproductive age.","[{'ForeName': 'Hagere', 'Initials': 'H', 'LastName': 'Yilma', 'Affiliation': 'Department of Prevention and Community Health, George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA. hyilma@gwu.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sedlander', 'Affiliation': 'Department of Prevention and Community Health, George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA.'}, {'ForeName': 'Rajiv N', 'Initials': 'RN', 'LastName': 'Rimal', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Ichhya', 'Initials': 'I', 'LastName': 'Pant', 'Affiliation': 'Department of Prevention and Community Health, George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA.'}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Munjral', 'Affiliation': 'Department of Social and Economic Empowerment, IPE Global Limited, New Delhi, Delhi, India.'}, {'ForeName': 'Satyanarayan', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'DCOR Consulting, Bhubaneswar, India.'}]",BMC public health,['10.1186/s12889-020-8271-2']
3080,31351922,"Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.","BACKGROUND


Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults.
METHODS


This study was a phase 1, open-label, single-arm, dose-escalation study of GLS-5300 done at the Walter Reed Army Institute for Research Clinical Trials Center (Silver Spring, MD, USA). We enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS. Eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0·67 mg, 2 mg, or 6 mg GLS-5300 administered by trained clinical site staff via a single intramuscular 1 mL injection at each vaccination at baseline, week 4, and week 12 followed immediately by co-localised intramuscular electroporation. Enrolment into the higher dose groups occurred after a safety monitoring committee reviewed the data following vaccination of the first five participants at the previous lower dose in each group. The primary outcome of the study was safety, assessed in all participants who received at least one study treatment and for whom post-dose study data were available, during the vaccination period with follow-up through to 48 weeks after dose 3. Safety was measured by the incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters. The secondary outcome was immunogenicity. This trial is registered at ClinicalTrials.gov (number NCT02670187) and is completed.
FINDINGS


Between Feb 17 and July 22, 2016, we enrolled 75 individuals and allocated 25 each to 0·67 mg, 2 mg, or 6 mg GLS-5300. No vaccine-associated serious adverse events were reported. The most common adverse events were injection-site reactions, reported in 70 participants (93%) of 75. Overall, 73 participants (97%) of 75 reported at least one solicited adverse event; the most common systemic symptoms were headache (five [20%] with 0·67 mg, 11 [44%] with 2 mg, and seven [28%] with 6 mg), and malaise or fatigue (five [20%] with 0·67 mg, seven [28%] with 2 mg, and two [8%] with 6 mg). The most common local solicited symptoms were administration site pain (23 [92%] with all three doses) and tenderness (21 [84%] with all three doses). Most solicited symptoms were reported as mild (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg) and were self-limiting. Unsolicited symptoms were reported for 56 participants (75%) of 75 and were deemed treatment-related for 26 (35%). The most common unsolicited adverse events were infections, occurring in 27 participants (36%); six (8%) were deemed possibly related to study treatment. There were no laboratory abnormalities of grade 3 or higher that were related to study treatment; laboratory abnormalities were uncommon, except for 15 increases in creatine phosphokinase in 14 participants (three participants in the 0·67 mg group, three in the 2 mg group, and seven in the 6 mg group). Of these 15 increases, five (33%) were deemed possibly related to study treatment (one in the 2 mg group and four in the 6 mg group). Seroconversion measured by S1-ELISA occurred in 59 (86%) of 69 participants and 61 (94%) of 65 participants after two and three vaccinations, respectively. Neutralising antibodies were detected in 34 (50%) of 68 participants. T-cell responses were detected in 47 (71%) of 66 participants after two vaccinations and in 44 (76%) of 58 participants after three vaccinations. There were no differences in immune responses between dose groups after 6 weeks. At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively.
INTERPRETATION


The GLS-5300 MERS coronavirus vaccine was well tolerated with no vaccine-associated serious adverse events. Immune responses were dose-independent, detected in more than 85% of participants after two vaccinations, and durable through 1 year of follow-up. The data support further development of the GLS-5300 vaccine, including additional studies to test the efficacy of GLS-5300 in a region endemic for MERS coronavirus.
FUNDING


US Department of the Army and GeneOne Life Science.",2019,"At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively.
","['Middle East respiratory syndrome (MERS', 'enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS', 'Between Feb 17 and July 22, 2016', 'healthy adults', 'Eligible participants']","['GLS-5300 MERS coronavirus DNA vaccine', 'anti-Middle East respiratory syndrome coronavirus DNA vaccine', 'GLS-5300']","['Safety and immunogenicity', 'headache', 'creatine phosphokinase', 'Seroconversion measured by S1-ELISA', 'T-cell responses', 'Neutralising antibodies', 'humoral and cellular responses', 'safety, tolerability, and immunogenicity', 'malaise or fatigue', 'Unsolicited symptoms', 'Immune responses', 'immune responses', 'immunogenicity', 'Safety', 'incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters']","[{'cui': 'C3694279', 'cui_str': 'Middle East Respiratory Syndrome'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3698360', 'cui_str': 'Middle East respiratory syndrome-related coronavirus'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0851536', 'cui_str': 'Administration site reaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",75.0,0.238334,"At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively.
","[{'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Roberts', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea. Electronic address: croberts@geneonels-us.com.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'ICON Clinical Research Management, Gaithersburg, MD, USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Castellano', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Paolino', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kar', 'Initials': 'K', 'LastName': 'Muthumani', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Reuschel', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Racine', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Lamarre', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Faraz I', 'Initials': 'FI', 'LastName': 'Zaidi', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Sagar B', 'Initials': 'SB', 'LastName': 'Kudchodkar', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Moonsup', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Darden', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Scott', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Remigio', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Ajay P', 'Initials': 'AP', 'LastName': 'Parikh', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Wise', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Duperret', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin Y', 'Initials': 'KY', 'LastName': 'Kim', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Hyeree', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bagarazzi', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'May', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kane', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kobinger', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Weiner', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Maslow', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30266-X']
3081,32054982,Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial.,"OBJECTIVE


To study the efficacy of intranasal fentanyl as an adjunct for pain management during screening for retinopathy of prematurity (ROP) in preterm infants.
STUDY DESIGN


In this single center, double blinded, randomized controlled trial, preterm neonates between 30 and 34 weeks postmenstrual age received either intranasal fentanyl (2 mcg/kg) or intranasal normal saline through a mucosal atomization device 5 min prior to the first ROP-screening examination. Both the groups received standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment). The primary outcome was premature infant pain profile-revised (PIPP-R) score during the screening.
RESULTS


A total of 111 infants were enrolled. PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001). There was no significant difference in the incidence of adverse effects.
CONCLUSION


Intranasal fentanyl significantly reduced the pain associated with retinal examination without increasing the risk of respiratory depression. Large RCTs are required to verify the efficacy and safety of intranasal fentanyl for acute procedural pain in neonates.
CLINICAL TRIAL REGISTRATION


CTRI/2017/12/011016.",2020,"PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001).","['preterm neonates between 30 and 34 weeks postmenstrual age received either', 'A total of 111 infants were enrolled', 'preterm infants']","['standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment', 'intranasal fentanyl', 'intranasal normal saline through a mucosal atomization device 5\u2009min prior to the first ROP-screening examination', 'Intranasal fentanyl']","['PIPP-R score', 'incidence of adverse effects', 'premature infant pain profile-revised (PIPP-R) score', 'pain', 'risk of respiratory depression']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0072510', 'cui_str': 'proxymetacaine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0031804', 'cui_str': 'Physical Containment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]",111.0,0.588892,"PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001).","[{'ForeName': 'Mythily', 'Initials': 'M', 'LastName': 'Sindhur', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India. drhari@suryahospitals.com.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Srinivasan', 'Affiliation': ""The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Nandkishor S', 'Initials': 'NS', 'LastName': 'Kabra', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Agashe', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0608-2']
3082,31352795,Donor Simvastatin Treatment in Heart Transplantation.,"BACKGROUND


Ischemia-reperfusion injury may compromise the short-term and long-term prognosis after heart transplantation. Experimental studies show that simvastatin administered to the organ donor is vasculoprotective and inhibits cardiac allograft ischemia-reperfusion injury.
METHODS


Eighty-four multiorgan donors were randomly assigned to receive 80 mg of simvastatin (42 donors) via nasogastric tube after declaration of brain death and upon acceptance as a cardiac donor, or to receive no simvastatin (42 donors). The primary efficacy end point was postoperative plasma troponin T and I levels during the first 24 hours after heart transplantation. Secondary end points included postoperative hemodynamics, inflammation, allograft function, rejections and rejection treatments, and mortality.   Results: Organ donor simvastatin treatment significantly reduced the heart recipient plasma levels of troponin T by 34% (14 900 ± 12 100 ng/L to 9800 ± 7900 ng/L, P=0.047), and troponin I by 40% (171 000 ± 151 000 ng/L to 103 000 ± 109 000 ng/L, P=0.023) at 6 hours after reperfusion, the levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) by 36% (32 800 ± 24 300 ng/L to 20 900 ± 15 900 ng/L; P=0.011) at 1 week, and the number of rejection treatments with hemodynamic compromise by 53% within the first 30 days (P=0.046). Donor simvastatin treatment did not affect donor lipid levels but was associated with a specific transplant myocardial biopsy gene expression profile, and a decrease in recipient postoperative plasma levels of CXCL10 (C-X-C motif chemokine 10), interleukin-1α, placental growth factor, and platelet-derived growth factor-BB. Postoperative hemodynamics, biopsy-proven acute rejections, and mortality were similar. No adverse effects were seen in recipients receiving noncardiac solid organ transplants from simvastatin-treated donors.
CONCLUSIONS


Donor simvastatin treatment reduces biomarkers of myocardial injury after heart transplantation, and-also considering its documented general safety profile-may be used as a novel, safe, and inexpensive adjunct therapy in multiorgan donation.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01160978.",2019,"ng/L, P=0.023) at 6 hours after reperfusion, the levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) by 36% (32 800 ± 24 300 ng/L to 20 900 ± 15 900 ng/L;","['Heart Transplantation', 'troponin I by 40% (171\u2009000 ± 151\u2009000', 'Eighty-four multiorgan donors']","['Donor simvastatin', 'simvastatin', 'simvastatin (42 donors) via nasogastric tube after declaration of brain death and upon acceptance as a cardiac donor, or to receive no simvastatin', 'Organ donor simvastatin', 'Donor Simvastatin']","['postoperative hemodynamics, inflammation, allograft function, rejections and rejection treatments, and mortality', 'heart recipient plasma levels of troponin T', 'levels of NT-proBNP', 'recipient postoperative plasma levels of CXCL10', 'Postoperative hemodynamics, biopsy-proven acute rejections, and mortality', 'postoperative plasma troponin T and I levels', 'number of rejection treatments with hemodynamic compromise', 'adverse effects', 'donor lipid levels']","[{'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C4274271', 'cui_str': 'Multiorgan donor'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0442474', 'cui_str': 'Via nasogastric tube (qualifier value)'}, {'cui': 'C0006110', 'cui_str': 'Brain Dead'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}]",,0.0631579,"ng/L, P=0.023) at 6 hours after reperfusion, the levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) by 36% (32 800 ± 24 300 ng/L to 20 900 ± 15 900 ng/L;","[{'ForeName': 'Antti I', 'Initials': 'AI', 'LastName': 'Nykänen', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Emil J', 'Initials': 'EJ', 'LastName': 'Holmström', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Krebs', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Dhaygude', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Kankainen', 'Affiliation': 'Translational Immunology Program Research Programs Unit (A.I.N., E.J.H., R.T., R.K., K.D., M.K., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Janne J', 'Initials': 'JJ', 'LastName': 'Jokinen', 'Affiliation': 'Department of Cardiology (J.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Jyri', 'Initials': 'J', 'LastName': 'Lommi', 'Affiliation': ''}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Helanterä', 'Affiliation': 'Transplantation and Liver Surgery (I.H.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Räisänen-Sokolowski', 'Affiliation': 'Pathology (A.R.-S.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Simo O', 'Initials': 'SO', 'LastName': 'Syrjälä', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Lemström', 'Affiliation': 'Transplantation Laboratory (A.I.N., E.J.H., R.T., R.K., K.D., S.O.S., K.B.L.), University of Helsinki and Helsinki University Hospital, Finland.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.039932']
3083,32055822,A Neurofunctional Domains Approach to Evaluate D1/D5 Dopamine Receptor Partial Agonism on Cognition and Motivation in Healthy Volunteers With Low Working Memory Capacity.,"BACKGROUND


Dopamine D1 receptor signaling plays key roles in core domains of neural function, including cognition and reward processing; however, many questions remain about the functions of circuits modulated by dopamine D1 receptor, largely because clinically viable, selective agonists have yet to be tested in humans.
METHODS


Using a novel, exploratory neurofunctional domains study design, we assessed the safety, tolerability, pharmacodynamics, and pharmacokinetics of PF-06412562, a selective D1/D5R partial agonist, in healthy male volunteers who met prespecified criteria for low working memory capacity. Functional magnetic resonance imaging, electrophysiologic endpoints, and behavioral paradigms were used to assess working memory, executive function, and motivation/reward processing following multiple-dose administration of PF-06412562. A total of 77 patients were assigned PF-06412562 (3 mg twice daily and 15 mg twice daily) or placebo administered for 5 to 7 days. Due to the exploratory nature of the study, it was neither powered for any specific treatment effect nor corrected for multiple comparisons.
RESULTS


Nominally significant improvements from baseline in cognitive endpoints were observed in all 3 groups; however, improvements in PF-06412562-treated patients were less than in placebo-treated participants. Motivation/reward processing endpoints were variable. PF-06412562 was safe and well tolerated, with no serious adverse events, severe adverse events, or adverse events leading to dose reduction or temporary discontinuation except for 1 permanent discontinuation due to increased orthostatic heart rate.
CONCLUSIONS


PF-06412562, in the dose range and patient population explored in this study, did not improve cognitive function or motivation/reward processing more than placebo over the 5- to 7-day treatment period.
CLINICALTRIALS.GOV IDENTIFIER


NCT02306876.",2020,"PF-06412562 was safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation, except for 1 permanent discontinuation due to increased orthostatic heart rate.
","['Healthy Volunteers With Low Working Memory Capacity', '77 subjects', 'healthy male volunteers who met pre-specified criteria for low working memory capacity']","['placebo', 'D1/D5 Dopamine Receptor Partial Agonism', 'PF-06412562']","['cognitive endpoints', 'Cognition and Motivation', 'safety, tolerability, pharmacodynamics, and pharmacokinetics of PF-06412562', 'Motivation/reward processing endpoints', 'safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation', 'cognitive function or motivation/reward processing', 'working memory, executive function, and motivation/reward processing', 'orthostatic heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034798', 'cui_str': 'Dopamine Receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",77.0,0.252281,"PF-06412562 was safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation, except for 1 permanent discontinuation due to increased orthostatic heart rate.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Balice-Gordon', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Garry D', 'Initials': 'GD', 'LastName': 'Honey', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chatham', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Arce', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Melissa Graham', 'Initials': 'MG', 'LastName': 'Naylor', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Wenlei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DeMartinis', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Harel', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Gabriel H', 'Initials': 'GH', 'LastName': 'Braley', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Lovingly', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'California Clinical Trials Medical Group/PAREXEL International, Glendale, CA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gray', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa007']
3084,31353695,Effect of Pereskia aculeata Mill. in vitro and in overweight humans: A randomized controlled trial.,"OBJECTIVES


The objective of this study was to investigate the influence of ora-pro-nobis (Pereskia aculeata Mill.) flour on the adhesion of probiotics to intestinal epithelial cells and to evaluate the effect of a product based on this flour on gastrointestinal symptoms, weight, body fat, glycemia, and lipid profile in overweight men.
METHODS


Microbiological counts (probiotic count, survival after in vitro gastrointestinal resistance, Caco-2 cell adhesion) were analyzed. A randomized, cross-over intervention was performed. Intestinal microbiota was indirectly assessed on the basis of consistency, color of feces, and gastrointestinal symptoms.
RESULTS


P. aculeata did not affect Lactobacillus casei adhesion to Caco-2 cells. Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
CONCLUSION


The consumption of ora-pro-nobis flour improved intestinal health. In addition, it maintained the high adherence of L. casei to intestinal cells as well as patient anthropometric and biochemical parameters.
PRACTICAL APPLICATIONS


Pereskia aculeata Mill. is well known in folk medicine and has several nutrients; however, there are few studies on this plant. This is the first study to analyze the influence of P. aculeata on bacterial adherence and the first cross-over clinical trial to evaluate the beneficial potential of ora-pro-nobis flour in overweight men. Thus, this study will contribute to the promotion of ora-pro-nobis as a functional ingredient and will arouse the interest of industries to develop related healthy foods. In addition, it is an effective dietary strategy to improve the gastrointestinal health of men.",2019,"Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
","['overweight men', 'overweight humans']","['ora-pro-nobis flour', 'ora-pro-nobis (Pereskia aculeata Mill', 'Pereskia aculeata Mill']","['Microbiological counts (probiotic count, survival after in vitro gastrointestinal resistance, Caco-2 cell adhesion', 'gastrointestinal symptoms and increased satiety', 'gastrointestinal symptoms, weight, body fat, glycemia, and lipid profile', 'Lactobacillus casei adhesion to Caco-2 cells', 'Intestinal microbiota']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0282560', 'cui_str': 'Caco-2 Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}]",,0.0265176,"Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
","[{'ForeName': 'Camilla Ribeiro', 'Initials': 'CR', 'LastName': 'Vieira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Bárbara Pereira', 'Initials': 'BP', 'LastName': 'da Silva', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Mariana Araújo Vieira', 'Initials': 'MAV', 'LastName': 'do Carmo', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Azevedo', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Denismar Alves', 'Initials': 'DA', 'LastName': 'Nogueira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Hércia Stampini', 'Initials': 'HS', 'LastName': 'Duarte Martino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Roberta Ribeiro', 'Initials': 'RR', 'LastName': 'Silva', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}]",Journal of food biochemistry,['10.1111/jfbc.12903']
3085,32039864,The effect of educational intervention on the knowledge and attitude of intensive care nurses in the prevention of pressure ulcers.,"BACKGROUND


Pressure ulcers can cause disability, which can lead to a default in patients' safety and results in frequent complications for patients.
OBJECTIVES


This study aimed to determine the effect of educational intervention on nurses' knowledge and attitude in preventing pressure ulcers.
METHODS


In this study, 67 nurses of ICU wards at Ilam University of Medical Sciences were randomly assigned to the experimental or control group. Data collection tools included the demographic characteristics questionnaire, the Pieper Pressure Ulcer Knowledge test (PUKT) and the Attitude toward Pressure Ulcer tool (APuP). In the experimental group, the nurses were allocated into groups of four-five persons and for each group four face-to-face training sessions and two virtual training sessions by means of educational videos on bed sores were performed. Gathered data were analyzed using SPSS software version 16, and descriptive and analytical tests were performed.
RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33) (P = 0.000), while in the control group it was 16.40 (3.13) and 17.54 (6.62) before intervention, which was not significant (P > 0.05). Furthermore, the APUP questionnaire score in the experimental group improved from 27.12 (2.13) to 39.37 (3.21) (P = 0.000), while in the control group it was 27.65 (1.71) and 28.37 (5.00) before intervention, which was not significant (P > 0.05).
CONCLUSIONS


Since educational intervention improved the knowledge and attitude of nurses in preventing pressure ulcers, it is required to conduct appropriate educational interventions to improve their knowledge and attitude.",2020,"RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33)",['67 nurses of ICU wards at Ilam University of Medical Sciences'],"['virtual training sessions by means of educational videos', 'educational intervention']","['APUP questionnaire score', 'PUKT questionnaire score', 'questionnaires of demographic characteristics, Pieper Pressure Ulcer Knowledge test (PUKT) and Attitude toward Pressure Ulcer tool (APuP']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0050822', 'cui_str': 'ApUp'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",67.0,0.0152738,"RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33)","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Karimian', 'Affiliation': 'Assistant Professor of Vascular Surgery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Khalighi', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salimi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Borji', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Tarjoman', 'Affiliation': 'Student Research Committee, Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Yosof', 'Initials': 'Y', 'LastName': 'Mahmoudi', 'Affiliation': 'Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",The International journal of risk & safety in medicine,['10.3233/JRS-191038']
3086,31765004,Medication Use Quality and Safety in Older Adults: 2018 Update.,"Improving the quality of medication use and medication safety is an important priority for prescribers who care for older adults. The objective of this article was to identify key articles from 2018 that address these issues. In addition, we selected four of these articles to annotate, critique, and discuss their broader implications for clinical practice. The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide). The second study, a nested case-control study using data from within the UK Clinical Practice Research Datalink, examined the association between anticholinergic exposure, overall and by anticholinergic medication class, and dementia risk in 40 770 older adults. The third study, a longitudinal cohort study of 1028 Swedish older adults, examined the association between antihypertensive medications and incident dementia. The last study was a randomized, double-blind, placebo-controlled trial that investigated the effect of daily low-dose aspirin (100 mg) for primary prevention on cardiovascular events and major hemorrhage in 19 144 community-dwelling older adults. Collectively, this current article provides insight into the pertinent topics of medication use quality and safety in older adults and helps raise awareness about optimal prescribing in older adults. J Am Geriatr Soc 67:2458-2462, 2019.",2019,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","['1028 Swedish older adults', 'prescribers who care for older adults', 'older adults', '19\u2009144 community-dwelling older adults', 'Older Adults', '40\u2009770 older adults']","['placebo', 'pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide', 'daily low-dose aspirin']","['cardiovascular events and major hemorrhage', 'quality of medication use and medication safety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4517873', 'cui_str': '770'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1028.0,0.0307063,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","[{'ForeName': 'Nagham J', 'Initials': 'NJ', 'LastName': 'Ailabouni', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Marcum', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Department of Medicine (Geriatrics), School of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Gray', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16243']
3087,31759092,Feeling needed: Effects of a randomized generativity intervention on well-being and inflammation in older women.,"Generativity, or concern for and contribution to the well-being of younger generations, plays an important role in successful aging. The purpose of this study was to develop a novel, writing-based intervention to increase feelings of generativity and test the effect of this intervention on well-being and inflammation in a sample of older women. Participants in this study (n = 73; mean age = 70.9 years, range 60-86 years) were randomly assigned to a 6-week generativity writing condition (writing about life experiences and sharing advice with others) or a control writing condition (neutral, descriptive writing). Self-reported measures of social well-being, mental health, and physical health, as well as objective measures of systemic and cellular levels of inflammation (plasma pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-α; genome-wide RNA transcriptional profiling), were assessed pre- and post-intervention. The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression. Thus, this study provides preliminary evidence for the ability of a novel, low-cost, low-effort intervention to favorably impact inflammation and well-being in older women.",2020,"The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression.","['older women', 'Participants in this study (n=73; mean age = 70.9 years, range 60-86 years', 'Older Women']","['6-week generativity writing condition (writing about life experiences and sharing advice with others) or a control writing condition (neutral, descriptive writing', 'Generativity Intervention']","['participation in social activities', 'psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression', 'social well-being, mental health, and physical health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0546092,"The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Moieni', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA; Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Robles', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Lieberman', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Breen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Okimoto', 'Affiliation': 'UCLA Clinical and Translational Research Center, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lengacher', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Jesusa M G', 'Initials': 'JMG', 'LastName': 'Arevalo', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Olmstead', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA; Department of Medicine, Division of Hematology-Oncology, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA. Electronic address: neisenbe@ucla.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.11.014']
3088,30855089,Randomized phase II trial comparing tumor bed alone with tumor bed and elective nodal postoperative radiotherapy in patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.,"This study compares the outcomes of different postoperative radiation fields for locoregionally advanced thoracic esophageal squamous cell carcinoma (ESCC) patients. This is a multi-institution randomized phase II trial and noninferior study. Patients with ESCC who had undergone esophagectomy (stage T3-4N0-3M0) were enrolled and randomized into the large-field irradiation arm (LFI; tumor bed and elective lymph node region) and small-field irradiation arm (SFI; tumor bed only). The primary endpoint was whether the disease-free survival (DFS) of SFI was not inferior to LFI. The secondary endpoint was to evaluate the rationality of the radiation target volume by analyzing failure patterns. One hundred twenty-one patients (64 patients for LFI and 57 patients for SFI, respectively) were eligible in this mid-time analysis. The 1- and 3-year DFS was 79.9%, 46.2% for LFI and 67.6%, 44.3% for SFI, respectively (P = 0.414). The locoregional recurrence-free survival (LRFS) of LFI was significantly better than that of SFI (P = 0.003). However, there were no significant differences in the distant metastasis-free survival and overall survival between the two arms (P = 0.332, P = 0.405, respectively). The failure patterns of the two arms were significantly different (P = 0.002). For pT3-4N0-3M0 ESCC patients, postoperative radiotherapy with SFI showed a similar survival outcome to LFI. However, the LRFS of patients with SFI was worse than that of patients with LFI.",2019,The locoregional recurrence-free survival (LRFS) of LFI was significantly better than that of SFI (P = 0.003).,"['One hundred twenty-one patients (64 patients for LFI and 57 patients for SFI, respectively) were eligible in this mid-time analysis', 'patients with locoregionally advanced thoracic esophageal squamous cell carcinoma', 'Patients with ESCC who had undergone esophagectomy (stage T3-4N0-3M0', 'locoregionally advanced thoracic esophageal squamous cell carcinoma (ESCC) patients']","['postoperative radiation fields', 'large-field irradiation arm (LFI; tumor bed and elective lymph node region) and small-field irradiation arm (SFI; tumor bed only', 'tumor bed alone with tumor bed and elective nodal postoperative radiotherapy']","['distant metastasis-free survival and overall survival', 'disease-free survival (DFS) of SFI', 'rationality of the radiation target volume by analyzing failure patterns', '1- and 3-year DFS', 'locoregional recurrence-free survival (LRFS) of LFI']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}]",121.0,0.0987532,The locoregional recurrence-free survival (LRFS) of LFI was significantly better than that of SFI (P = 0.003).,"[{'ForeName': 'X-W', 'Initials': 'XW', 'LastName': 'Cai', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'M-N', 'Initials': 'MN', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'C-X', 'Initials': 'CX', 'LastName': 'Lv', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'X-L', 'Initials': 'XL', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doz013']
3089,31725060,Long-Term Outcomes of HIV-Infected Women Receiving Antiretroviral Therapy After Transferring Out of an Integrated Maternal and Child Health Service in South Africa.,"BACKGROUND


Integrated maternal and child health (MCH) services improve women's postpartum antiretroviral therapy (ART) outcomes during breastfeeding; however, long-term outcomes after transfer to general ART services remain unknown.
METHODS


The MCH-ART trial demonstrated that maternal retention and viral suppression at 12-months postpartum were improved significantly among women randomized to integrated MCH services continued in the antenatal clinic through cessation of breastfeeding (MCH-ART arm) compared with immediate transfer to general ART services postpartum (standard of care). We reviewed electronic health records for all women who participated in the MCH-ART trial to ascertain retention and gaps in care and invited all women for a study visit 36- to 60-months postpartum including viral load testing.
RESULTS


Of 471 women in MCH-ART, 450 (96%) contributed electronic health record data and 353 (75%) completed the study visit (median 44-month postpartum). At this time, outcomes were identical in both trial arms: 67% retained in care (P = 0.994) and 56% with viral loads <50 copies/mL (P = 0.751). Experiencing a gap in care after delivery was delayed in the MCH-ART arm with 17%, 36%, and 45% of women experienced a gap in care by 12-, 24-, and 36-months postpartum compared with 35%, 48%, and 57% in the standard of care arm, respectively.
CONCLUSIONS


The benefits of integrated maternal HIV and child health care did not persist after transfer to general ART services. The transfer of women postpartum to routine adult care is a critical period requiring interventions to support continuity of HIV care.",2020,"At this time, outcomes were identical in both trial arms: 67% retained in care (p=0.994); 56% with viral loads <50 copies/mL (p=0.751).","['HIV-infected women receiving antiretroviral therapy after transferring out of an integrated maternal and child health service in South Africa', 'all women who participated in the MCH-ART trial to ascertain retention and gaps in care and invited all women for a study visit 36-60 months postpartum including viral load testing', '471 women in MCH-ART, 450 (96%) contributed electronic health record data and 353 (75%) completed the study visit (median 44 months postpartum']",['Integrated maternal and child health (MCH) services'],['maternal retention and viral suppression'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0913047', 'cui_str': '(HP)MCH'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",471.0,0.196827,"At this time, outcomes were identical in both trial arms: 67% retained in care (p=0.994); 56% with viral loads <50 copies/mL (p=0.751).","[{'ForeName': 'Tamsin K', 'Initials': 'TK', 'LastName': 'Phillips', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Pheposadi', 'Initials': 'P', 'LastName': 'Mogoba', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Gomba', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zerbe', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002236']
3090,32043709,Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial.,"AIM


To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial.
METHODS AND RESULTS


The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40-49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (P interaction   = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI.
CONCLUSION


In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT01205776.",2020,"No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF.","['1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4', 'Patients with HFrEF', 'left main coronary artery revascularization', 'patients with left main coronary artery disease (LMCAD) undergoing']","['percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG', 'left ventricular ejection fraction', 'LVEF', 'CABG', 'LMCAD to PCI with everolimus-eluting stents', 'left ventricular ejection fraction (LVEF']","['death, stroke, or myocardial infarction at 3\u2009years', 'postoperative hospital stay', 'composite rate of death, stroke or myocardial infarction', 'hospital stay after PCI', '3-year risk of all-cause death', 'rate of all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",1804.0,0.338392,"No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF.","[{'ForeName': 'Daniel J F M', 'Initials': 'DJFM', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milojevic', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai Heart at Mount Saint Luke's, New York, NY, USA.""}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Imperial College London, London, UK.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.'}]",European journal of heart failure,['10.1002/ejhf.1681']
3091,31200349,Maintenance of Fitness and Quality-of-Life Benefits From Supervised Exercise Offered as Supportive Care for Breast Cancer.,"BACKGROUND


Overwhelming randomized controlled trial evidence demonstrates that exercise has positive health impacts during and after treatment for breast cancer. Yet, evidence generated by studies in which exercise programs are delivered outside a tightly controlled randomized trial setting is limited. The purpose of this study was to assess the effectiveness of an evidence-based exercise program with real-world implementation on physical fitness and quality of life (QoL).
PATIENTS AND METHODS


Oncologists referred women with early-stage breast cancer who were scheduled to receive adjuvant chemotherapy. The program consisted of supervised aerobic and resistance exercise of moderate to vigorous intensity 3 times per week until the end of treatment (chemotherapy ± radiotherapy), then twice per week for 10 weeks, followed by once per week for 10 weeks. Health-related physical fitness and QoL were assessed at baseline, end of treatment, end of program, and 1-year follow-up.
RESULTS


A total of 73 women were enrolled. Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01). By the end of the program, VO2peak, heart rate recovery, waist circumference, and some aspects of QoL were improved (all P<.01) relative to baseline. One year later, VO2peak, QoL, and waist circumference were maintained relative to end of program, whereas the improvements in strength and heart rate recovery had dissipated (all P<.01).
CONCLUSIONS


Evidence-based exercise programming delivered with real-world implementation maintained VO2peak, strength, and QoL during adjuvant treatment and improved these measures after treatment completion among women with breast cancer. Continued guidance and support may be required for long-term maintenance of strength improvements in this population.",2019,"Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01).","['women with breast cancer', 'breast cancer', 'A total of 73 women were enrolled', 'Oncologists referred women with early-stage breast cancer who were scheduled to receive']","['evidence-based exercise program with real-world implementation', 'supervised aerobic and resistance exercise of moderate to vigorous intensity 3 times per week until the end of treatment (chemotherapy ± radiotherapy', 'adjuvant chemotherapy']","['VO2peak, heart rate recovery, waist circumference, and some aspects of QoL', 'strength and heart rate recovery', 'muscular strength', 'physical fitness and quality of life (QoL', 'Maintenance of Fitness and Quality-of-Life Benefits', 'Estimated peak VO2 (VO2peak), QoL, and body weight', 'VO2peak, QoL, and waist circumference']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0034380'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",73.0,0.0897266,"Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01).","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wollmann', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alis', 'Initials': 'A', 'LastName': 'Bonsignore', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada; and.'}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Van Patten', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7276']
3092,31200357,Cost-Effectiveness of Cabozantinib in the Second-Line Treatment of Advanced Hepatocellular Carcinoma.,"BACKGROUND


Treatment options are limited for patients with advanced hepatocellular carcinoma (HCC) that progresses after treatment with sorafenib. Cabozantinib, an oral small molecule inhibitor of multiple tyrosine kinase receptors, recently showed improved overall survival (OS) compared with placebo in sorafenib-pretreated patients with advanced HCC in the CELESTIAL trial. This study assessed the cost-effectiveness of cabozantinib for second-line treatment of patients with advanced HCC from a US healthcare system perspective.
PATIENTS AND METHODS


Cost and utility data were extracted from the CELESTIAL trial and used to determine the cost-effectiveness of cabozantinib compared with placebo plus best supportive care. The main outcome of this study was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained by using cabozantinib compared with placebo plus best supportive care in sorafenib-pretreated HCC.
RESULTS


In the base-case analysis using data from the CELESTIAL trial, the incremental QALY and ICER were 0.067 and $1,040,675 for cabozantinib compared with placebo and best supportive care. OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER. In one-way sensitivity analyses, there were no scenarios in which cabozantinib was cost-effective. In a cost-threshold analysis, cabozantinib would have to be priced at least $50 per pill to be cost-effective considering a willingness to pay of $100,000 per QALY. Although the CELESTIAL trial demonstrated that cabozantinib improves OS compared with placebo in patients with HCC that progresses after treatment with sorafenib, our analysis shows that cabozantinib is not a cost-effective therapy in this scenario.
CONCLUSIONS


At current costs, cabozantinib is not cost-effective for second-line therapy of HCC in the United States.",2019,"OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER.","['Advanced Hepatocellular Carcinoma', 'patients with advanced HCC from a US healthcare system perspective', 'patients with HCC', 'patients with advanced hepatocellular carcinoma (HCC']","['sorafenib', 'Cabozantinib', 'placebo', 'cabozantinib']","['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY', 'overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.192508,"OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER.","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Pedro N', 'Initials': 'PN', 'LastName': 'Aguiar', 'Affiliation': 'Centro de Estudos e Pesquisa de Hematologia e Oncologia, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Mónica L', 'Initials': 'ML', 'LastName': 'Cordón', 'Affiliation': 'Department of Hemato-Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; and.'}, {'ForeName': 'Yanin', 'Initials': 'Y', 'LastName': 'Chavarri-Guerra', 'Affiliation': 'Department of Hemato-Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; and.'}, {'ForeName': 'Gilberto de Lima', 'Initials': 'GL', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7275']
3093,31867648,The Importance of Estimating Causal Effects for Evaluating a Nicotine Standard for Cigarettes.,"Recent evidence from randomized clinical trials (RCTs) of very low nicotine content (VLNC) cigarettes indicates that smokers randomized to VLNC cigarettes had significantly lower cigarette use, dependence, and biomarkers of exposure than smokers randomized to normal nicotine content control cigarettes. In these trials, a substantial number of participants did not adhere to their randomized treatment assignment, i.e., they used commercial cigarettes not provided by the trial in place of or in addition to the VLNC cigarettes provided by the trial. As with most RCTs, the analysis of these trials followed the intention-to-treat principle, where participants are analyzed according to their randomized treatment assignment regardless of adherence. Alternately, the analysis of an RCT could focus on the estimation and testing of the causal effect of the intervention, which is the treatment effect if all subjects were to adhere to their randomized treatment assignment. In this commentary, we compare these two approaches, highlighting the important role of causal estimation and inference for evaluating the regulatory effect of a nicotine standard for cigarettes. Additionally, we review the results of the secondary analyses of randomized trials of VLNC cigarettes using causal inference methodology to account for non-adherence to the assigned treatment and discuss the implications for a nicotine standard for cigarettes.",2019,"Recent evidence from randomized clinical trials (RCTs) of very low nicotine content (VLNC) cigarettes indicates that smokers randomized to VLNC cigarettes had significantly lower cigarette use, dependence, and biomarkers of exposure than smokers randomized to normal nicotine content control cigarettes.",[],"['VLNC cigarettes', 'nicotine content (VLNC) cigarettes']",[],[],"[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",[],,0.0933003,"Recent evidence from randomized clinical trials (RCTs) of very low nicotine content (VLNC) cigarettes indicates that smokers randomized to VLNC cigarettes had significantly lower cigarette use, dependence, and biomarkers of exposure than smokers randomized to normal nicotine content control cigarettes.","[{'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Carroll', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz119']
3094,32035738,"Use of healthy conversation skills to promote healthy diets, physical activity and gestational weight gain: Results from a pilot randomised controlled trial.","OBJECTIVES


This study evaluated the use of Healthy Conversation Skills (a client-centered communication approach to behaviour change) in supporting women to achieve optimal gestational-weight-gain and health behaviours.
METHODS


Seventy pregnant women were randomised to the control or intervention group. Study visits and phone calls were delivered by Registered Dietitians (RDs) to women in the intervention and control groups. The intervention RD was trained in Healthy Conversation Skills while the control RD was not. Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
RESULTS


Women in the intervention group improved their diet score between baseline and visit 2, while the control group did not. At 34 weeks, women in the control group reported being sedentary for longer than women in the intervention group. There were no differences in total gestational-weight-gain between the groups.
CONCLUSIONS


Pregnant women who interacted with an RD using Healthy Conversation Skills reported positive outcomes in health behaviours.
PRACTICE IMPLICATIONS


Healthy Conversation Skills shows promise as an approach to initiate, and maintain discussions promoting health behaviour change in pregnancy.",2020,"Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
","['Seventy pregnant women', 'Pregnant women who interacted with an RD using Healthy Conversation Skills']","['Healthy Conversation Skills (a client-centered communication approach to behaviour change', 'healthy conversation skills']","['Diet, physical activity and gestational-weight-gain', 'total gestational-weight-gain', 'physical activity and gestational weight gain', 'diet score']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",70.0,0.0819398,"Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Adam', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barker', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Donna P', 'Initials': 'DP', 'LastName': 'Manca', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, T6G 2T4, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lawrence', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rhonda C', 'Initials': 'RC', 'LastName': 'Bell', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada. Electronic address: Rhonda.bell@ualberta.ca.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.001']
3095,32035739,An educational intervention in rural Uganda: Risk-targeted home talks by village health workers.,"OBJECTIVE


Evaluate the effectiveness of home talks (HTs), a novel model of health education delivered by village health workers (VHWs) with primary-level education to rural African mothers. Talk recipients were assessed by health census to be at risk for ill-health in one of 5 ways: malnutrition, diarrhea, respiratory disease, HIV, and poverty due to family size.
METHODS


Each participant received a pre-test, immediate post-test and delayed post-test on their assigned HT topic and a pre-test and delayed post-test on a randomly assigned control topic. Differences in scoring were examined against controls and over time using paired t-tests and general linear regression analysis, respectively.
RESULTS


Subjects lost knowledge gained from the HTs over time, but what they retained at 3 months was far greater than what they learned about the control topics (p-values <0.0001), independent of subjects' educational level.
CONCLUSION


Targeted HTs to people with health census-identified risk factors resulted in learning and significant retention of knowledge.
PRACTICE IMPLICATIONS


Positive behavioral change resulting from health education has been shown in diverse contexts. This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.",2020,This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.,"['rural Uganda', 'rural African mothers', 'village health workers']","['pre-test, immediate post-test and delayed post-test on their assigned HT topic and a pre-test and delayed post-test', 'home talks (HTs), a novel model of health education delivered by village health workers (VHWs) with primary-level education', 'educational intervention']",[],"[{'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0018701'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0476883,This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: cmoon@mail.einstein.yu.edu.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Alizadeh', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital & Boston Medical Center, 300 Longwood Ave., Boston, MA, 02115, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: faraz.alizadeh@childrens.harvard.edu.""}, {'ForeName': 'Gloria Fung', 'Initials': 'GF', 'LastName': 'Chaw', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: gfungch@montefiore.org.'}, {'ForeName': 'Mary Immaculate', 'Initials': 'MI', 'LastName': 'Mulongo', 'Affiliation': 'Kisoro District Hospital, Kisoro, Uganda; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: immaculatemulongo5@gmail.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schaefle', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: kenneth.schaefle@med.einstein.yu.edu.'}, {'ForeName': 'Morgen', 'Initials': 'M', 'LastName': 'Yao-Cohen', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: myaocoh@montefiore.org.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Musominalli', 'Affiliation': 'Kisoro District Hospital, Kisoro, Uganda; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: sammusominali@gmail.com.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Paccione', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: gpaccion@montefiore.org.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.015']
3096,32035748,Pilot Study Suggests Smartphone Application Knowledge Improves Resident Transesophageal Echocardiography Knowledge: A Randomized Controlled Trial.,"OBJECTIVE


The objective of this study was to determine whether an asynchronous smartphone-based application with image-based questions would improve anesthesiology resident transesophageal echocardiography (TEE) knowledge compared with standard intraoperative teaching alone.
DESIGN


Prospective, single-blinded, pilot, randomized controlled trial.
SETTING


Large university teaching hospital.
PARTICIPANTS


Participants were anesthesiology residents on their cardiac anesthesiology rotation.
INTERVENTIONS


EchoEducator, a TEE image-based smartphone application of learning content through questions, was developed. Content was derived from the Examination of Special Competence in Basic Perioperative Transesophageal Echocardiography and the Objective Structured Clinical Examination portion of the APPLIED Examination and focused on identification of basic TEE views, cardiac structures, and pathology. Residents were randomly assigned to receive access to either the application or to standard intraoperative teaching. Thirty residents met inclusion criteria, and 18 residents completed the study. A pre-intervention assessment was given at the beginning of the rotation, and a post-intervention assessment was given after 2 weeks.
MEASUREMENTS


The primary outcome was the difference between the post-test score and the pre-test score. Standard bivariate statistics and the chi-square test were used for categorical variables, and the Student t test was used for continuous variables. Tests were 2-sided, and statistical significance was set at p < 0.05. The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group.
CONCLUSIONS


This study supports the hypothesis that use of a smartphone-based asynchronous educational application improves TEE knowledge compared with traditional modalities alone. This supports an opportunity to improve medical education by expanding the role of web-based asynchronous learning.",2020,"The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group.
","['Thirty residents met inclusion criteria, and 18 residents completed the study', 'Participants were anesthesiology residents on their cardiac anesthesiology rotation', 'Large university teaching hospital']","['standard intraoperative teaching alone', 'asynchronous smartphone-based application with image-based questions', 'smartphone-based asynchronous educational application', 'standard intraoperative teaching']","['score', 'TEE knowledge', 'post-test score and the pre-test score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.141162,"The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group.
","[{'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Linganna', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA; Thomas Jefferson University Hospital, Philadelphia, PA. Electronic address: Regina.Linganna@jefferson.edu.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lourdes Al', 'Initials': 'LA', 'LastName': 'Ghofaily', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Mackay', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Spelde', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elizabeth Y', 'Initials': 'EY', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Kukafka', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Feinman', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Augoustides', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.12.051']
3097,32028926,Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol.,"BACKGROUND


The low utilisation of current treatment services by people with gambling problems highlights the need to explore new modalities of delivering treatment interventions. This protocol presents the design of a pragmatic randomized control trial aimed at assessing the effectiveness and acceptability of cognitive behavioral therapy (CBT) delivered via a mobile app for people with self-reported gambling problems.
METHODS


An innovative CBT mobile app, based on Deakin University's GAMBLINGLESS online program, has been adapted with end-users (Manaaki). Six intervention modules have been created. These are interwoven with visual themes to represent a journey of recovery and include attributes such as avatars, videos, and animations to support end-user engagement. An audio facility is used throughout the app to cater for different learning styles. Personalizing the app has been accomplished by using greetings in the participant's language and their name (e.g. Kia ora Tāne) and by creating personalized feedback. A pragmatic, randomized control two-arm single-blind trial, will be conducted in New Zealand. We aim to recruit 284 individuals. Eligible participants are ≥18 years old, seeking help for their gambling, have access to a smartphone capable of downloading an app, able to understand the English language and are willing to provide follow-up information at scheduled time points. Allocation is 1:1, stratified by ethnicity, gender, and gambling symptom severity based on the Gambling Symptom Assessment Scale (G-SAS). The intervention group will receive the full mobile cognitive behavioural programme and the waitlist group will receive a simple app that counts down the time left before they have access to the full app and the links to the data collection tools. Data collection for both groups are: baseline, 4-, 8-, and 12-weeks post-randomisation. The primary outcome is a change in G-SAS scores. Secondary measures include changes in gambling urges, frequency, expenditure, and readiness to change. Indices of app engagement, utilisation and acceptability will be collected throughout the delivery of the intervention.
DISCUSSION


If effective, this study will contribute to the improvement of health outcomes for people experiencing gambling problems and have great potential to reach population groups who do not readily engage with current treatment services.
ETHICS APPROVAL


NZ Health and Disability Ethics Committee (Ref: 19/STH/204) TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ANZCTRN 12619001605189) Registered 1 November 2019.",2020,"Allocation is 1:1, stratified by ethnicity, gender, and gambling symptom severity based on the Gambling Symptom Assessment Scale (G-SAS).","['284 individuals', 'people with self-reported gambling problems', 'Eligible participants are ≥18\u2009years old, seeking help for their gambling, have access to a smartphone capable of downloading an app, able to understand the English language and are willing to provide follow-up information at scheduled time points', 'people experiencing gambling problems', 'people with gambling problems']","['cognitive behavioral therapy (CBT', 'full mobile cognitive behavioural programme and the waitlist group will receive a simple app that counts down the time left before they have access to the full app and the links to the data collection tools', 'Manaaki - a cognitive behavioral therapy mobile health app']","['Indices of app engagement, utilisation and acceptability', 'change in G-SAS scores', 'changes in gambling urges, frequency, expenditure, and readiness to change']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0376245', 'cui_str': 'English language (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.156188,"Allocation is 1:1, stratified by ethnicity, gender, and gambling symptom severity based on the Gambling Symptom Assessment Scale (G-SAS).","[{'ForeName': 'Gayl', 'Initials': 'G', 'LastName': 'Humphrey', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, New Zealand. g.humphrey@auckland.ac.nz.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, New Zealand.'}, {'ForeName': 'Nicki', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rodda', 'Affiliation': 'Social and Community Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merkouris', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Newcombe', 'Affiliation': 'Center for Addiction Research, University of Auckland, Private Bag 92019, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'Social and Community Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Vili', 'Initials': 'V', 'LastName': 'Nosa', 'Affiliation': 'Pacific Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ruwhui-Collins', 'Affiliation': 'Hapai te Hauora, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, New Zealand.'}]",BMC public health,['10.1186/s12889-020-8304-x']
3098,31785395,Biological motion during inflammation in humans.,"Biological motion is a powerful perceptual cue that can reveal important information about the inner state of an individual. Activation of inflammatory processes likely leads to changes in gait, posture, and mobility patterns, but the specific characteristics of inflammation-related biological motion have not been characterized. The aim of this study was to determine the effect of inflammation on gait and motion in humans. Systemic inflammation was induced in 19 healthy volunteers with an intravenous injection of lipopolysaccharide (2 ng/kg body weight). Biological motion parameters (walking speed, stride length and time, arm, leg, head, and shoulder angles) were assessed during a walking paradigm and the timed-up-and-go test. Cytokine concentrations, body temperature, and sickness symptoms were measured. During inflammation, compared to placebo, participants exhibited shorter, slower, and wider strides, less arm extension, less knee flexion, and a more downward-tilting head while walking. They were also slower and took a shorter first step in the timed-up-and-go test. Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion. These findings show that biological motion contains clear information about the inflammatory status of an individual, and may be used by peers or artificial intelligence to recognize that someone is sick or contagious.",2020,"Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion.","['19 healthy volunteers with an intravenous injection of', 'humans']","['placebo', 'lipopolysaccharide']","['Biological motion parameters (walking speed, stride length and time, arm, leg, head, and shoulder angles', 'Higher interleukin-6 concentrations, stronger sickness symptoms', 'Systemic inflammation', 'slower, and wider strides, less arm extension, less knee flexion', 'Cytokine concentrations, body temperature, and sickness symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}]",19.0,0.0530894,"Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Department of Psychology, New York University, 6 Washington Place, 10003 New York, NY, USA.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, 75 Francis Stress, 02115 Boston, MA, USA.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Olsson', 'Affiliation': 'Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paues Göranson', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, 18288 Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.11.019']
3099,30746642,Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial.,"BACKGROUND


Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits.
OBJECTIVE


To test the hypothesis that a ""Pre-Visit Prioritization"" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes.
DESIGN


We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system.
PARTICIPANTS


Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal.
INTERVENTIONS


Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care.
MAIN MEASURES


Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences.
KEY RESULTS


During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms.
CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation.
TRIAL REGISTRY


NCT02375932.",2019,"CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","['patients with diabetes', '1276 patients had at least one eligible visit', 'Eligible patients had at least 1\xa0year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c)\u2009>\u2009=\u20098.0%, and were registered users of the KPNC online patient portal', 'March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system', 'patients with type 2 diabetes', 'Patients with Poorly Controlled Diabetes to Identify Visit Priorities']","['secure email through the KPNC online portal with a link to the EHR', 'usual care']","['visit communication and glycemic control', 'patient-provider communication and patient care experiences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017313'}]",,0.111043,"CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","[{'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Vo', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Uratsu', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Estacio', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Oakland Medical Center, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Stacey E', 'Initials': 'SE', 'LastName': 'Alexeeff', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Alyce S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA. Richard.W.Grant@KP.org.'}]",Journal of general internal medicine,['10.1007/s11606-018-4756-4']
3100,31331617,Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers.,"BACKGROUND


Numerous anecdotal reports suggest that repeated use of very low doses of lysergic acid diethylamide (LSD), known as microdosing, improves mood and cognitive function. These effects are consistent both with the known actions of LSD on serotonin receptors and with limited evidence that higher doses of LSD (100-200 μg) positively bias emotion processing. Yet, the effects of such subthreshold doses of LSD have not been tested in a controlled laboratory setting. As a first step, we examined the effects of single very low doses of LSD (0-26 μg) on mood and behavior in healthy volunteers under double-blind conditions.
METHODS


Healthy young adults (N = 20) attended 4 laboratory sessions during which they received 0 (placebo), 6.5, 13, or 26 μg of LSD in randomized order at 1-week intervals. During expected peak drug effect, they completed mood questionnaires and behavioral tasks assessing emotion processing and cognition. Cardiovascular measures and body temperature were also assessed.
RESULTS


LSD produced dose-related subjective effects across the 3 doses (6.5, 13, and 26 μg). At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content. Other mood measures, cognition, and physiological measures were unaffected.
CONCLUSIONS


Single microdoses of LSD produced orderly dose-related subjective effects in healthy volunteers. These findings indicate that a threshold dose of 13 μg of LSD might be used safely in an investigation of repeated administrations. It remains to be determined whether the drug improves mood or cognition in individuals with symptoms of depression.",2019,"At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content.","['Healthy Human Volunteers', 'individuals with symptoms of depression', 'healthy volunteers', 'Healthy young adults (N\xa0= 20) attended 4', 'healthy volunteers under double-blind conditions']","['lysergic acid diethylamide (LSD', 'LSD', 'Lysergic Acid Diethylamide', 'laboratory sessions during which they received 0 (placebo']","['Cardiovascular measures and body temperature', 'mood questionnaires and behavioral tasks assessing emotion processing and cognition', 'positivity ratings']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.154263,"At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois; Interdisciplinary Scientist Training Program, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Schepers', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bremmer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois. Electronic address: hdew@uchicago.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.05.019']
3101,31905644,"The Effect of Respiratory Muscle Training on the Pulmonary Function, Lung Ventilation, and Endurance Performance of Young Soccer Players.","This study investigated whether the addition of eight weeks of inspiratory muscle training (IMT) to a regular preseason soccer training program, including incremental endurance training (IET), would change pulmonary function, lung ventilation, and aerobic performance in young soccer players. Sixteen club-level competitive junior soccer players (mean age 17.63 ± 0.48 years, height 182 ± 0.05 cm, body mass 68.88 ± 4.48 kg) participated in the study. Participants were randomly assigned into two groups: experimental (n = 8) and control (n = 8). Both groups performed regular preseason soccer training, including endurance workouts as IET. In addition to this training, the experimental group performed additional IMT for eigght weeks with a commercially available respiratory muscle trainer (Threshold IMT), with a total of 80 inhalations (twice per day, five days per week). Pre- and post-intervention tests of pulmonary function, maximal inspiratory pressure, and the Cooper test were implemented. Eight weeks of IMT had a positive impact on expiratory muscle strength ( p  = 0.001); however, there was no significant effect on respiratory function parameters. The results also indicate increased efficiency of the inspiratory muscles, contributing to an improvement in aerobic endurance, measured by VO₂max estimated from running distance in the cardiorespiratory Cooper test ( p  < 0.005).",2019,"Eight weeks of IMT had a positive impact on expiratory muscle strength ( p  = 0.001); however, there was no significant effect on respiratory function parameters.","['Young Soccer Players', 'young soccer players', 'Sixteen club-level competitive junior soccer players (mean age 17.63 ± 0.48 years, height 182 ± 0.05 cm, body mass 68.88 ± 4.48 kg) participated in the study']","['regular preseason soccer training program, including incremental endurance training (IET', 'IMT', 'inspiratory muscle training (IMT', 'Respiratory Muscle Training', 'regular preseason soccer training, including endurance workouts as IET']","['pulmonary function, lung ventilation, and aerobic performance', 'pulmonary function, maximal inspiratory pressure, and', 'respiratory function parameters', 'efficiency of the inspiratory muscles', 'Pulmonary Function, Lung Ventilation, and Endurance Performance', 'aerobic endurance', 'expiratory muscle strength']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",182.0,0.0184127,"Eight weeks of IMT had a positive impact on expiratory muscle strength ( p  = 0.001); however, there was no significant effect on respiratory function parameters.","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Mackała', 'Affiliation': 'Department of Track and Field, University School of Physical Education, Wroclaw, Ul. Paderewskiego 35, 51-612 Wrocław, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kurzaj', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, Poland, Ul. Paderewskiego 35, 51-612 Wrocław, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Okrzymowska', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, Poland, Ul. Paderewskiego 35, 51-612 Wrocław, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Stodółka', 'Affiliation': 'Department of Track and Field, University School of Physical Education, Wroclaw, Ul. Paderewskiego 35, 51-612 Wrocław, Poland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Coh', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Gortanova ul. 22, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Rożek-Piechura', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, Poland, Ul. Paderewskiego 35, 51-612 Wrocław, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17010234']
3102,31303390,"2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.","BACKGROUND


For several cardiometabolic risk factors, values considered within normal range are associated with an increased risk of cardiovascular morbidity and mortality. We aimed to investigate the short-term and long-term effects of calorie restriction with adequate nutrition on these risk factors in healthy, lean, or slightly overweight young and middle-aged individuals.
METHODS


CALERIE was a phase 2, multicentre, randomised controlled trial in young and middle-aged (21-50 years), healthy non-obese (BMI 22·0-27·9 kg/m 2 ) men and women done in three clinical centres in the USA. Participants were randomly assigned (2:1) to a 25% calorie restriction diet or an ad libitum control diet. Exploratory cardiometabolic risk factor responses to a prescribed 25% calorie restriction diet for 2 years were evaluated (systolic, diastolic, and mean blood pressure; plasma lipids; high-sensitivity C-reactive protein; metabolic syndrome score; and glucose homoeostasis measures of fasting insulin, glucose, insulin resistance, and 2-h glucose, area-under-the curve for glucose, and insulin from an oral glucose tolerance test) analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00427193.
FINDINGS


From May 8, 2007, to Feb 26, 2010, of 238 participants that were assessed, 218 were randomly assigned to and started a 25% calorie restriction diet (n=143, 66%) or an ad libitum control diet (n=75, 34%). Individuals in the calorie restriction group achieved a mean reduction in calorie intake of 11·9% (SE 0·7; from 2467 kcal to 2170 kcal) versus 0·8% (1·0) in the control group, and a sustained mean weight reduction of 7·5 kg (SE 0·4) versus an increase of 0·1 kg (0·5) in the control group, of which 71% (mean change in fat mass 5·3 kg [SE 0·3] divided by mean change in weight 7·5 kg [0·4]) was fat mass loss. Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure. In addition, calorie restriction resulted in a significant improvement at 2 years in C-reactive protein (p=0·012), insulin sensitivity index (p<0·0001), and metabolic syndrome score (p<0·0001) relative to control. A sensitivity analysis revealed the responses to be robust after controlling for relative weight loss changes.
INTERPRETATION


2 years of moderate calorie restriction significantly reduced multiple cardiometabolic risk factors in young, non-obese adults. These findings suggest the potential for a substantial advantage for cardiovascular health of practicing moderate calorie restriction in young and middle-aged healthy individuals, and they offer promise for pronounced long-term population health benefits.
FUNDING


National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.",2019,"Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure.","['healthy, lean, or slightly overweight young and middle-aged individuals', 'From May 8, 2007, to Feb 26, 2010, of 238 participants that were assessed, 218 were randomly assigned to and started a 25', 'young and middle-aged (21-50 years), healthy non-obese (BMI 22·0-27·9 kg/m 2 ) men and women done in three clinical centres in the USA', 'young, non-obese adults', 'young and middle-aged healthy individuals']","['calorie restriction diet', '25% calorie restriction diet or an ad libitum control diet', 'ad libitum control diet', 'calorie restriction', 'calorie restriction with adequate nutrition']","['multiple cardiometabolic risk factors', 'Exploratory cardiometabolic risk factor responses', 'conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure', 'mean reduction in calorie intake', 'C-reactive protein (p=0·012), insulin sensitivity index (p<0·0001), and metabolic syndrome score (p<0·0001) relative to control', 'evaluated (systolic, diastolic, and mean blood pressure; plasma lipids; high-sensitivity C-reactive protein; metabolic syndrome score; and glucose homoeostasis measures of fasting insulin, glucose, insulin resistance, and 2-h glucose, area-under-the curve for glucose, and insulin from an oral glucose tolerance test']","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",238.0,0.0819923,"Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA. Electronic address: william.kraus@duke.edu.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke Center for Aging and Human Development, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Krupa Das', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA; Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rochon', 'Affiliation': 'Rho Federal Systems, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Holloszy', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA; Department of Clinical and Experimental Sciences, Brescia University, Brescia, Italy; School of Medicine and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30151-2']
3103,31764336,"The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.","BACKGROUND


Drain removal after TKA can be painful. Prior research suggests that the ""cough trick,"" in which a patient coughs at the same time she or he receives an injection, effectively decreases pain. To our knowledge, this intervention has not been evaluated as a way to reduce pain during other brief but painful interventions, such as removal of closed-suction drains after orthopaedic surgery.
QUESTION/PURPOSE


Does the cough trick reduce pain while a surgeon is removing a closed-suction drain after TKA?
METHODS


Fifty-six patients with primary osteoarthritis who underwent primary TKA were randomized into two groups: drain removal as the patient coughed (n = 28 patients; three men, 25 women) or drain removal using the usual process, without the cough trick (n = 28 patients; three men, 25 women). The study groups were not different in terms of gender, BMI, surgical time, or other baseline variables, and other than the addition of the cough trick, there were no differences in surgical treatment or other elements of aftercare. Likewise, at baseline, the verbal numeric rating scale (VNRS) score for pain before the drain was removed was not different between the groups (3.1 ± 1.7 versus 3.3 ± 1.3; p = 0.72). The level of pain before and during drain removal was recorded using a VNRS by an orthopaedic surgeon who was not involved in the care of the study patients. We considered the minimum clinically important difference on the 10-point scale to be 2 points, based on prior evidence.
RESULTS


The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
CONCLUSIONS


The cough trick during removal of a closed-suction drain tube in patients undergoing TKA reduced the level of pain in this small randomized trial. We suggest that surgeons consider this technique when removing drains after TKA because it is a noninvasive technique and it is easy to perform. Because the cough trick has been shown by others to be effective at reducing pain during venipuncture and parenteral injections, and we found it was effective for that purpose during drain removal after TKA, we believe this finding probably generalizes well to most minor procedures that cause transient, sharp pain. We suggest that it could be used to make such procedures more comfortable for patients, as well as for drain removal in other types of surgery where drains still are commonly used (including spine surgery and tumor surgery).
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","['n = 28 patients; three men, 25 women', 'after Total Knee Arthroplasty', 'n = 28 patients; three men, 25 women) or', 'Fifty-six patients with primary osteoarthritis who underwent primary TKA']","['drain removal as the patient coughed', 'Cough Trick"" Reduces Pain During Removal of Closed-suction Drains', 'drain removal using the usual process, without the cough trick']","['verbal numeric rating scale (VNRS) score for pain before the drain', 'level of pain', 'mean ± SD VNRS for the pain level during drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",25.0,0.143798,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'V. Yuenyongviwat, K. Iamthanaporn, P. Tuntarattanapong, T. Hongnaparak, Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': ''}, {'ForeName': 'Pakjai', 'Initials': 'P', 'LastName': 'Tuntarattanapong', 'Affiliation': ''}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000901']
3104,32009491,Effects of showing the operating room on preoperative anxiety and hemodynamics among patients with hypertension: A randomized controlled trial.,"PURPOSE


Anxiety is one of the most important causes of hypertension, increasing direct blood pressure and affecting postoperative morbidity and mortality. The aim of this study was to investigate the effects of showing the operating room on preoperative anxiety and hemodynamics among patients with hypertension.
METHODS


We enrolled 90 patients with hypertension undergoing cholecystectomy in this trial. Patients were randomly divided into two groups using a sealed-envelope system. Group STOR was shown the operating room the day before surgery, while Group No STOR was not shown the operating room.
RESULTS


State-Trait Anxiety Inventory scores measured on the day of surgery were lower for Group STOR (43.2 ± 6.0) than Group No STOR (49.8 ± 7.9) ( p  = .001). Systolic ( p  = .001,  p  = .006, respectively), diastolic ( p  = .001,  p  = .004, respectively), and heart rate ( p  = .018,  p  = .031, respectively) values in the operation room and preoperative unit were lower in Group STOR than in Group No STOR. The number of postponed operations in Group STOR was lower than in Group No STOR ( p  = .043), and the patient satisfaction score in Group STOR was higher than in Group No STOR ( p  = .031).
CONCLUSION


In patients with hypertension, preoperative anxiety, blood pressure, heart rate, and respiratory rate all increase in the preoperative unit and operation room. Our findings indicate that showing the operating room to patients with hypertension decreases preoperative anxiety, as well as blood pressure and heart rate inside the operating room and preoperative unit. It also reduces the number of postponed operations and increases patient satisfaction.",2020,"The number of postponed operations in Group STOR was lower than in Group No STOR ( p  = .043), and the patient satisfaction score in Group STOR was higher than in Group No STOR ( p  = .031).","['90 patients with hypertension undergoing cholecystectomy in this trial', 'patients with hypertension']",[],"['preoperative anxiety, blood pressure, heart rate, and respiratory rate', 'heart rate', 'State-Trait Anxiety Inventory scores', 'diastolic', 'preoperative anxiety and hemodynamics', 'preoperative anxiety', 'number of postponed operations', 'blood pressure and heart rate', 'Systolic', 'patient satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]",[],"[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}]",90.0,0.0170854,"The number of postponed operations in Group STOR was lower than in Group No STOR ( p  = .043), and the patient satisfaction score in Group STOR was higher than in Group No STOR ( p  = .031).","[{'ForeName': 'Nureddin', 'Initials': 'N', 'LastName': 'Yuzkat', 'Affiliation': 'Department of Anesthesiology and Reanimation, Van Yuzuncu Yıl University School of Medicine , Van, Turkey.'}, {'ForeName': 'Celaleddin', 'Initials': 'C', 'LastName': 'Soyalp', 'Affiliation': 'Department of Anesthesiology and Reanimation, Van Yuzuncu Yıl University School of Medicine , Van, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Turk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Van Yuzuncu Yıl University School of Medicine , Van, Turkey.'}, {'ForeName': 'Siddik', 'Initials': 'S', 'LastName': 'Keskin', 'Affiliation': 'Department of Biostatistics, Van Yuzuncu Yıl University School of Medicine , Van, Turkey.'}, {'ForeName': 'Nurcin', 'Initials': 'N', 'LastName': 'Gulhas', 'Affiliation': 'Department of Anesthesiology and Reanimation, Van Yuzuncu Yıl University School of Medicine , Van, Turkey.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1723619']
3105,31881614,"A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars.","Objective evidence for the role of inhibition of collagen cross-linking in human scar using a nontoxic topical inhibitor, 1,4-diaminobutane (1,4 DAB), in patients with scars at risk for hypertrophic scar formation is presented. The authors used a concentration of 1,4 DAB of 0.8% (weight/volume) in a cream base similar to Glaxal Base. Application was once per day at night. The control was treated with cream base alone. In treatment phase studies at 2 months, tissue biopsies were performed and used to determine a therapeutic effect biochemically in paired scars harvested chosen with typical hypertrophic scars at two major treatment centers. Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid. A subset of paired scars (n = 15) was also analyzed for soluble procollagen type III amino propeptide. The effect was a significant increase in procollagen type III amino propeptide in the scars treated with 1,4 DAB compared with sham-treated scars: 47.75 ± 4.6 µg/mg wet weight versus 39.08 ± 6.02 µg/mg wet weight, respectively. Levels of tissue 1,4 DAB was found to be twice as high in the presence of the active cream versus in the tissue of the control group. In subsequent prophylaxis studies, the authors treated 44 breast reduction patients prospectively with active cream to one or the other side in a double-blind randomized fashion. Hardness (in grams) measured using a Rex Durometer at 6 and 12 weeks postoperatively along with photographs were analyzed. The mean value ± SD of 24.98 ± 1.2 g on the active side versus 31.76 ± 1.1 g on the sham side was significantly different (p < 0.05). The patient scale scores of the Patient and Observer Scar Assessment Scale were also requested by survey in a responding 27-patient subgroup at a minimum 1 year postoperatively, and the differences between the two sides were found to be statistically significant, where the mean on the active side was 14.07 ± 1.34 and the mean on the sham side was 21.41 ± 1 (p < 0.05). The results are evidence to support the use of this agent in prevention of hypertrophic scars. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, II.",2020,Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid.,"['patients with scars at risk for hypertrophic scar formation', 'Human Hypertrophic Scars']","['nontoxic topical inhibitor, 1,4-diaminobutane (1,4 DAB', '1,4-Diaminobutane']","['Levels of tissue', 'procollagen type III amino propeptide', 'patient scale scores of the Patient and Observer Scar Assessment Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034170', 'cui_str': 'Tetramethylenediamine'}, {'cui': 'C0086162', 'cui_str': 'Dab (substance)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0336604', 'cui_str': 'Patient scale, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",,0.0475427,Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid.,"[{'ForeName': 'Kenneth N', 'Initials': 'KN', 'LastName': 'Dolynchuk', 'Affiliation': 'Winnipeg, Manitoba; and Edmonton, Alberta, Canada From the Section of Plastic Surgery, Department of Surgery, University of Manitoba; and the Division of Plastic Surgery, Department of Surgery and Critical Care Medicine, University of Alberta.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Tredget', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006413']
3106,32014538,Effects of the Mother-Child Education Program on Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon: A Pilot Randomized Controlled Trial.,"OBJECTIVE


Few randomized controlled trials (RCTs) have explored the implementation and impact of early childhood parenting education programs in very fragile contexts and humanitarian settings. We tested the effects of a group-based intervention, the Mother-Child Education Program (MOCEP), on parenting stress and practices among two refugee communities and one other marginalized community in Beirut, Lebanon.
METHOD


A pilot wait-list RCT was conducted to assess the program's impact on maternal, child (average age: 4 years), and dyadic outcomes. A total of 106 mother-child dyads were randomly assigned to either the intervention group (n = 53) or the wait-list control group (n = 53). Analysis was conducted by modified intention-to-treat and supplemental analyses through multiple imputation of missing post-intervention data.
RESULTS


Forty families (38%) withdrew early from the study. After completing the program, mothers in the intervention group showed a reduction in their harsh parenting practices, as indexed by the Disciplinary Style Questionnaire (Cohen's d = -0.76, 95% CI = -1.24, -0.27) and in their level of parenting stress, as indexed by the Parenting Stress Index-Short Form (PSI-SF; Cohen's d = -0.90, 95% CI = -1.39, -0.40). Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention. However, we did not detect any positive impact on behavioral or emotional outcomes among the children.
CONCLUSION


Our analyses suggest that MOCEP had a positive impact on disciplinary practices and parenting stress in a context of high fragility, but that broader effects on maternal and child outcomes may be dependent on program attendance and the availability of other services. We discuss implications of this pilot study for practice and research of a largely unexplored area of program evaluation.
CLINICAL TRIAL REGISTRATION INFORMATION


Mother and Child Education Program in Palestinian Refugee Camps; https://clinicaltrials.gov; NCT02402556.",2020,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"['106 mother-child dyads', 'Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon', 'Forty families (38%) withdrew early from the study']","['wait-list control group', 'Mother-Child Education Program', 'MOCEP', 'group-based intervention, the Mother-Child Education Program (MOCEP']","['reduction in their harsh parenting', 'Disciplinary Style Questionnaire', 'behavioral and emotional status']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023190', 'cui_str': 'Lebanese Republic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",106.0,0.128697,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"[{'ForeName': 'Liliana A', 'Initials': 'LA', 'LastName': 'Ponguta', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut. Electronic address: angelica.ponguta@yale.edu.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Issa', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aoudeh', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Maalouf', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sascha D', 'Initials': 'SD', 'LastName': 'Hein', 'Affiliation': 'Dr. Hein is with Freie Universität Berlin, Germany.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Zonderman', 'Affiliation': 'Ms. Zonderman is with the Section of Hospital Medicine, Biological Sciences Division, The University of Chicago, Illinois.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Katsovich', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Khoshnood', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bick', 'Affiliation': 'Dr. Bick is with The University of Houston, Texas.'}, {'ForeName': 'Abir', 'Initials': 'A', 'LastName': 'Awar', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Nourallah', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Householder', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Moore', 'Affiliation': 'Ms. Moore is with the University of Delaware, Newark.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Salah', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Pia R', 'Initials': 'PR', 'LastName': 'Britto', 'Affiliation': 'Dr. Britto is with UNICEF, New York.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.010']
3107,31345710,"Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study.","BACKGROUND


The emergence and spread of resistance in Plasmodium falciparum malaria to artemisinin combination therapies in the Greater Mekong subregion poses a major threat to malaria control and elimination. The current study is part of a multi-country, open-label, randomised clinical trial (TRACII, 2015-18) evaluating the efficacy, safety, and tolerability of triple artemisinin combination therapies. A very high rate of treatment failure after treatment with dihydroartemisinin-piperaquine was observed in Thailand, Cambodia, and Vietnam. The immediate public health importance of our findings prompted us to report the efficacy data on dihydroartemisinin-piperaquine and its determinants ahead of the results of the overall trial, which will be published later this year.
METHODS


Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam were randomly assigned to receive dihydroartemisinin-piperaquine with or without mefloquine, as part of the TRACII trial. The primary outcome was the PCR-corrected efficacy at day 42. Next-generation sequencing was used to assess the prevalence of molecular markers associated with artemisinin resistance (kelch13 mutations, in particular Cys580Tyr) and piperaquine resistance (plasmepsin-2 and plasmepsin-3 amplifications and crt mutations). This study is registered with ClinicalTrials.gov, number NCT02453308.
FINDINGS


Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received dihydroartemisinin-piperaquine. The overall Kaplan-Meier estimate of PCR-corrected efficacy of dihydroartemisinin-piperaquine at day 42 was 50·0% (95% CI 41·1-58·3). PCR-corrected efficacies for individual sites were 12·7% (2·2-33·0) in northeastern Thailand, 38·2% (15·9-60·5) in western Cambodia, 73·4% (57·0-84·3) in Ratanakiri (northeastern Cambodia), and 47·1% (33·5-59·6) in Binh Phuoc (southwestern Vietnam). Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe). Compared with the results of our previous TRACI trial in 2011-13, the prevalence of molecular markers of artemisinin resistance (kelch13 Cys580Tyr mutations) and piperaquine resistance (plasmepsin2/3 amplifications and crt mutations) has increased substantially in the Greater Mekong subregion in the past decade.
INTERPRETATION


Dihydroartemisinin-piperaquine is not treating malaria effectively across the eastern Greater Mekong subregion. A highly drug-resistant P falciparum co-lineage is evolving, acquiring new resistance mechanisms, and spreading. Accelerated elimination of P falciparum malaria in this region is needed urgently, to prevent further spread and avoid a potential global health emergency.
FUNDING


UK Department for International Development, Wellcome Trust, Bill & Melinda Gates Foundation, Medical Research Council, and National Institutes of Health.",2019,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","['Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam', 'Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received', 'Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam']","['dihydroartemisinin-piperaquine with or without mefloquine', 'dihydroartemisinin-piperaquine']","['plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe', 'efficacy, safety, and tolerability', 'PCR-corrected efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",539.0,0.149168,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","[{'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'van der Pluijm', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu Thi', 'Initials': 'NT', 'LastName': 'Hoa', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Thuy-Nhien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Viet', 'Initials': 'NV', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Podjanee', 'Initials': 'P', 'LastName': 'Jittamala', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Borimas', 'Initials': 'B', 'LastName': 'Hanboonkunupakarn', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kitipumi', 'Initials': 'K', 'LastName': 'Chutasmit', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Chalermpon', 'Initials': 'C', 'LastName': 'Saelow', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Runjarern', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Weerayuth', 'Initials': 'W', 'LastName': 'Kaewmok', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Rupam', 'Initials': 'R', 'LastName': 'Tripura', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sovann', 'Initials': 'S', 'LastName': 'Yok', 'Affiliation': 'Pailin Provincial Health Department, Pailin, Cambodia.'}, {'ForeName': 'Seila', 'Initials': 'S', 'LastName': 'Suon', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Sreng', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sivanna', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Sampov Meas Referral Hospital, Pursat, Cambodia.'}, {'ForeName': 'Savuth', 'Initials': 'S', 'LastName': 'Oun', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia; School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Rekol', 'Initials': 'R', 'LastName': 'Huy', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; WorldWide Antimalarial Resistance Network Asia Regional Centre, Bangkok, Thailand.'}, {'ForeName': 'Kesinee', 'Initials': 'K', 'LastName': 'Chotivanich', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ashley', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Vientiane, Laos.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Waithira', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Phaik Yeong', 'Initials': 'PY', 'LastName': 'Cheah', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Maude', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Harvard T H Chan School of Public Health, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Amato', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Pearson', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Gonçalves', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Jacob', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Hamilton', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winterberg', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': 'Kwiatkowski', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; The Royal Society of Thailand, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nicholas Pj', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Olivo', 'Initials': 'O', 'LastName': 'Miotto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: arjen@tropmedres.ac.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30391-3']
3108,31837232,Twenty-four-hour subjective and pharmacological effects of ad-libitum electronic and combustible cigarette use among dual users.,"BACKGROUND AND AIMS


Relative pharmacological effects of e-cigarettes and cigarettes during 24 hours of ad-libitum use have not been described. In this study, 24-hour blood plasma nicotine concentrations and 48-hour subjective effects with use of cigarettes and e-cigarettes were measured among dual users.
DESIGN


Two-arm within-subject cross-over design with preferred e-cigarette or cigarette ad-libitum use over 48 hours.
SETTING


Hospital research ward in San Francisco, California, USA.
PARTICIPANTS


Thirty-six healthy dual users of e-cigarettes and cigarettes (n = 8, 25% females).
MEASUREMENTS


Twenty-four-hour blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects.
FINDINGS


Analyses used analysis of variance (ANOVA)-based mixed models with order of product (e-cigarette or cigarette) and product type (combustible cigarette or type of e-cigarette) as fixed effects, and subject as a repeated effect. During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence. Compared to cigarette smoking, nicotine exposure for variable-power tank users was similar, while cig-a-like (t (30)   = 2.71, P = 0.011, d = 0.745) and fixed-power tank users (t (30)   = 3.37, P = 0.002, d = 0.993) were exposed to less nicotine. Cigarettes were rated higher than e-cigarettes on some desirable subjective effects (e.g. psychological reward, t (322)   = 7.24 P < 0.001, d = 0.432), but withdrawal symptom reduction was comparable. No differences were found between e-cigarette types, but Bayes factors indicate that these measures were insensitive.
CONCLUSIONS


During a 24-hour period in a hospital setting in the United States, nicotine exposure for dual users of e-cigarettes and cigarettes was similar when using cigarettes or variable-power tank devices only but was lower for those using cig-a-like or fixed-power devices only. Despite lower nicotine levels, all types of e-cigarette were effective in preventing withdrawal symptoms. E-cigarettes were rated less rewarding than cigarettes.",2020,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","['Thirty-six healthy dual users of e-cigarettes and cigarettes (n\xa0', 'Hospital research ward in San Francisco, California, USA']",[],"['withdrawal symptoms', '24-hour blood plasma nicotine concentrations', 'blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects', 'withdrawal symptom reduction']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",36.0,0.0290211,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","[{'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14931']
3109,31995688,Family History of Gastric Cancer and  Helicobacter pylori  Treatment.,"BACKGROUND


Helicobacter pylori  infection and a family history of gastric cancer are the main risk factors for gastric cancer. Whether treatment to eradicate  H. pylori  can reduce the risk of gastric cancer in persons with a family history of gastric cancer in first-degree relatives is unknown.
METHODS


In this single-center, double-blind, placebo-controlled trial, we screened 3100 first-degree relatives of patients with gastric cancer. We randomly assigned 1838 participants with  H. pylori  infection to receive either eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin [500 mg], each taken twice daily for 7 days) or placebo. The primary outcome was development of gastric cancer. A prespecified secondary outcome was development of gastric cancer according to  H. pylori  eradication status, assessed during the follow-up period.
RESULTS


A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group). During a median follow-up of 9.2 years, gastric cancer developed in 10 participants (1.2%) in the treatment group and in 23 (2.7%) in the placebo group (hazard ratio, 0.45; 95% confidence interval [CI], 0.21 to 0.94; P = 0.03 by log-rank test). Among the 10 participants in the treatment group in whom gastric cancer developed, 5 (50.0%) had persistent  H. pylori  infection. Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70). Adverse events were mild and were more common in the treatment group than in the placebo group (53.0% vs. 19.1%; P<0.001).
CONCLUSIONS


Among persons with  H. pylori  infection who had a family history of gastric cancer in first-degree relatives,  H. pylori  eradication treatment reduced the risk of gastric cancer. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT01678027.).",2020,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","['1838 participants with  H. pylori  infection to receive either', 'persons with  H. pylori  infection who had a family history of gastric cancer in first-degree relatives', 'A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group', 'patients with gastric cancer', 'Family History of Gastric Cancer and  Helicobacter pylori  Treatment']","['placebo', 'eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin']","['risk of gastric cancer', 'persistent  H. pylori  infection', 'Adverse events', 'development of gastric cancer', 'persistent infection', 'Gastric cancer', 'gastric cancer', 'development of gastric cancer according to  H. pylori  eradication status, assessed during the follow-up period']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",1838.0,0.379924,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","[{'ForeName': 'Il Ju', 'Initials': 'IJ', 'LastName': 'Choi', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Chan Gyoo', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jong Yeul', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Myeong-Cherl', 'Initials': 'MC', 'LastName': 'Kook', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jungnam', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}]",The New England journal of medicine,['10.1056/NEJMoa1909666']
3110,30904207,Effects of almond consumption on metabolic function and liver fat in overweight and obese adults with elevated fasting blood glucose: A randomised controlled trial.,"BACKGROUND


Almonds are a rich source of bioactive components. This study examined the effects of daily almond consumption on glycaemic regulation, liver fat concentration and function, adiposity, systemic inflammation and cardiometabolic health.
METHODS


76 adults with elevated risk of type 2 diabetes (T2D) or T2D (age: 60.7 ± 7.7 years, body mass index: 33.8 ± 5.6 kg/m 2 ) were randomly assigned to daily consumption of either 2 servings of almonds (AS:56 g/day) or an isocaloric, higher carbohydrate biscuit snack (BS) for 8 weeks. Glycosylated haemoglobin (HbA1c), glycaemic variability (GV), liver fat, serum aminotransferases, body weight and composition, markers of cardio-metabolic risk and systemic inflammation were assessed at baseline and week 8.
RESULTS


No group differential effects were observed on HbA1c, GV, body weight and composition, liver fat and aminotransferases, cardio-metabolic health and inflammatory markers (all P > 0.05). For serum TC/HDL-C ratio a significant gender × treatment × time interaction occurred (P < 0.01), such that in women TC/HDL-C ratio was significantly reduced after AS compared to BS (-0.36 [0.26] mmol/L [n = 14] vs. -0.14 [0.32] mmol/L [n = 17]; P = 0.05), but not in men (P = 0.52).
CONCLUSIONS


Compared to BS, AS consumed between meals did not substantially alter glycaemic regulation, liver fat or function, adiposity, and metabolic health and inflammatory markers. Serum TC/HDL-C ratio improved in women, but not in men with AS; but as this sub-analysis was not defined a priori the results should be interpreted with caution. Further research should examine the longer-term health effects of regular almond consumption and differential gender responses.
CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE


Australia New Zealand Clinical Trial Registry: ACTRN12616000571471 (https://www.anzctr.org.au).",2019,"No group differential effects were observed on HbA1c, GV, body weight and composition, liver fat and aminotransferases, cardio-metabolic health and inflammatory markers (all P > 0.05).","['overweight and obese adults with elevated fasting blood glucose', '76 adults with elevated risk of type 2 diabetes (T2D) or T2D (age: 60.7\xa0±\xa07.7 years, body mass index: 33.8\xa0±\xa05.6\xa0kg/m 2 ']","['daily consumption of either 2 servings of almonds (AS:56\xa0g/day) or an isocaloric, higher carbohydrate biscuit snack (BS', 'almond consumption', 'daily almond consumption']","['Serum TC/HDL-C ratio', 'metabolic function and liver fat', 'Glycosylated haemoglobin (HbA1c), glycaemic variability (GV), liver fat, serum aminotransferases, body weight and composition, markers of cardio-metabolic risk and systemic inflammation', 'women TC/HDL-C ratio', 'glycaemic regulation, liver fat or function, adiposity, and metabolic health and inflammatory markers', 'glycaemic regulation, liver fat concentration and function, adiposity, systemic inflammation and cardiometabolic health', 'serum TC/HDL-C ratio', 'HbA1c, GV, body weight and composition, liver fat and aminotransferases, cardio-metabolic health and inflammatory markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0440286', 'cui_str': 'Almonds'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",76.0,0.0984311,"No group differential effects were observed on HbA1c, GV, body weight and composition, liver fat and aminotransferases, cardio-metabolic health and inflammatory markers (all P > 0.05).","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Bowen', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, PO Box 10041, Adelaide 5000, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, PO Box 10041, Adelaide 5000, Australia.'}, {'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, PO Box 10041, Adelaide 5000, Australia.'}, {'ForeName': 'Cuong', 'Initials': 'C', 'LastName': 'Tran', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, PO Box 10041, Adelaide 5000, Australia.'}, {'ForeName': 'Geraint B', 'Initials': 'GB', 'LastName': 'Rogers', 'Affiliation': 'Microbiome Research, South Australian Health and Medical Research Institute, PO Box 11060, Adelaide 5001, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences and Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Lidcombe 2141, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, University of Adelaide, 5000, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, Riverside Corporate Park, 11 Julius Avenue, North Ryde, 2113, Australia. Electronic address: grant.brinkworth@csiro.au.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2018.12.088']
3111,31764266,Applying the Exploration Preparation Implementation Sustainment (EPIS) Framework to the Kigali Imbereheza Project for Rwandan Adolescents Living With HIV.,"BACKGROUND


Sub-Saharan African adolescents living with HIV face challenges to antiretroviral therapy (ART) adherence. Poor mental health drives nonadherence but can be improved with cognitive behavioral therapy (CBT). CBT delivered by peers may strengthen effects while building capacity for sustainment in low-income countries. This case study retrospectively applied the Exploration Preparation Implementation Sustainment framework to characterize the execution of the Kigali Imbereheza Project, a 2-arm individually randomized group controlled trial of Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
METHODS


YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95%. Participants (n = 356, 51% female, M = 16.78 years) living with HIV were randomized to TI-CBTe or usual care. Two YLs co-led TI-CBTe sessions over 2 months for a total of 12 hours, while other YL observed and rated fidelity. Participants reported on YL competence. Additional data evaluated feasibility, acceptability, uptake, and fidelity.
RESULTS


In the Exploration phase, focus groups, stakeholder meetings, and individual interviews revealed strong consensus for delivering TI-CBT to reduce adolescent depression and trauma and improve ART adherence. In the Preparation phase, curriculum revisions were made, YLs were successfully trained, and a cascading supervision model was established. In the Implementation phase, YL delivered TI-CBTe with close monitoring and supervision. Findings revealed strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment.
CONCLUSIONS


Exploration Preparation Implementation Sustainment can guide implementation planning and delivery and evaluate implementation outcomes.",2019,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","['YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95', 'Participants (n = 356, 51% female, M = 16.78 years) living with HIV', 'Rwandan Adolescents Living With HIV', 'adolescents living with HIV']","['cognitive behavioral therapy (CBT', 'Trauma-Informed Adherence-Enhanced CBT (TI-CBTe', 'TI-CBTe or usual care', 'CBT']","['adolescent depression and trauma and improve ART adherence', 'YL competence', 'feasibility, acceptability, uptake, and fidelity', 'strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0563725,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","[{'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Mardge H', 'Initials': 'MH', 'LastName': 'Cohen', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ingabire', 'Affiliation': 'WE-ACTx for Hope Clinic (WFH) Kigali, Rwanda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fabri', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Emerson', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Remera', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Manzi', 'Affiliation': 'Department of Medicine, University Teaching Hospital of Kigali (CHUK), Kigali, Rwanda.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Nsanzimana', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002204']
3112,31785189,Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design.,"AIMS


To evaluate the effects of the two main components of a personalized normative feedback (PNF) [normative feedback only (NFO); and consequences feedback only (CFO)] compared with the full intervention (PNF) in reducing alcohol use and consequences.
DESIGN


Three-arm pragmatic randomized controlled trial with dismantling design and 1-, 3- and 6-month follow-ups.
SETTING


Web-based among Brazilian college students.
PARTICIPANTS


College students (aged 18-30 years) who reported alcohol use in the last 3 months (n = 5476).
INTERVENTIONS


(1) Full PNF (a) drinking profile; (b) normative comparisons; (c) practical costs; (d) alcohol consequences; (e) strategies to decrease risks; (2) NFO components (a), (b) and (e); or (3) CFO components (c), (d) and (e).
MEASUREMENTS


The primary outcome was change in Alcohol Use Disorders Identification Test (AUDIT) score; secondary outcomes were the number of alcohol consequences, drinking frequency and typical/maximum number of drinks. We used mixed models with multiple imputation and a pattern-mixture model to account for attrition. Subgroup analyses considered participant motivation to know more about their drinking (less motivated versus motivated).
FINDINGS


Dismantled components reduced rather than increased AUDIT score compared to full PNF, with significant effects for NFO at 1 month [b = -0.23, 95% confidence interval (CI) = -0.46; -0.002] and for CFO at 3 months (b = -0.33, 95% CI = -0.62; -0.03). Compared with PNF, NFO reduced the number of alcohol consequences at 1 month (b = -0.16, 95% CI = -0.25; -0.06) and drinking frequency at 3 months (b = -0.42, 95% CI = -0.79; -0.05), but increased the number of typical drinks at 6 months (b = 0.38, 95% CI = 0.04; 0.72). CFO reduced drinking frequency at 3 months (b = -0.37, 95% CI = -0.73; -0.01). Attrition models confirmed all results, except for the NFO effect on typical drinks and drinking frequency. Subgroup analyses indicated superiority of dismantled components among the students less motivated in knowing more about their drinking.
CONCLUSIONS


There was no evidence that either the normative or the consequences components of a web-based personalized normative feedback intervention to reduce alcohol use and its consequences contributed to intervention effects. There was some evidence of adverse effects of personalized normative feedback, and these results were driven by 20% of participants who were less motivated in knowing more about their drinking.",2020,CFO reduced drinking frequency at 3 months (b=-0.37 95%CI:-0.73;-0.01).,"['college students', 'College students (18-30 years old) who reported alcohol use in the last three months (N=5,476', 'Brazilian college students']","['PNF, NFO', 'Personalised Normative Feedback (PNF) intervention', 'web-based personalised normative feedback intervention', 'full intervention (PNF', 'Personalised Normative Feedback (PNF) (Normative feedback only -NFO; and Consequences feedback only - CFO']","['NFO effect on typical drinks and drinking frequency', 'CFO reduced drinking frequency', 'number of alcohol consequences', 'adverse effects of PNF', 'drinking frequency', 'number of alcohol consequences, drinking frequency, and typical/maximum number of drinks', 'number of typical drinks']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.123842,CFO reduced drinking frequency at 3 months (b=-0.37 95%CI:-0.73;-0.01).,"[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Bedendo', 'Affiliation': 'Research Center on Health and Substance Use (NEPSIS), Department of Psychobiology, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Gaume', 'Affiliation': 'Alcohol Treatment Centre, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Altay A L', 'Initials': 'AAL', 'LastName': 'Souza', 'Affiliation': 'Associação Fundo de Incentivo à Pesquisa (AFIP), São Paulo, Brazil.'}, {'ForeName': 'Maria Lucia O S', 'Initials': 'MLOS', 'LastName': 'Formigoni', 'Affiliation': 'Disciplina de Medicina e Sociologia do Abuso de Drogas - Departamento de Psicobiologia, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Research Center on Health and Substance Use (NEPSIS), Department of Psychobiology, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}]","Addiction (Abingdon, England)",['10.1111/add.14923']
3113,32019699,Beyond Performance Metrics: Automatic Deep Learning Retinal OCT Analysis Reproduces Clinical Trial Outcome.,"PURPOSE


To validate the efficacy of a fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics by measuring the primary outcome of a clinical trial for macular telangiectasia type 2 (MacTel2).
DESIGN


Evaluation of diagnostic test or technology.
PARTICIPANTS


A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324) randomized to 1 of 2 treatment groups METHODS: The ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm. The change in EZ defect area from baseline to month 24 was calculated and analyzed according to the clinical trial protocol.
MAIN OUTCOME MEASURE


Difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups.
RESULTS


The difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups measured by the fully automatic segmentation algorithm was 0.072±0.035 mm 2  (P = 0.021). This was comparable to the outcome of the clinical trial using semiautomatic measurements by expert readers, 0.065±0.033 mm 2  (P = 0.025).
CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial. This approach, to validate the performance of an automatic segmentation algorithm on the primary clinical trial end point, provides a robust gauge of its clinical applicability.",2020,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","['A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324', 'macular telangiectasia type 2 (MacTel2']","['ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm', 'fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics']",['change in EZ defect area'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C4521693', 'cui_str': 'Telangiectasia of macula lutea'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",92.0,0.117519,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Loo', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Ophthalmology, Emmes, Rockville, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Molecular Medicine, The Scripps Research Institute, La Jolla, California; The Lowy Medical Research Institute, La Jolla, California.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Farsiu', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina; Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina. Electronic address: sina.farsiu@duke.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.12.015']
3114,31820546,Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial.,"AIM


Describe the distinguishing features of heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial.
METHODS AND RESULTS


Key background characteristics were evaluated in 5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event. Differences within the VICTORIA population were assessed and compared with PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure). VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  . Baseline standard of HF care was very good: 60% received triple therapy. Their N-terminal pro-B-type natriuretic peptide was 3377 pg/mL [interquartile range (IQR) 1992-6380]. Natriuretic peptides were 30% higher level in the 67% patients with HF hospitalization <3 months, compared to those within 3-6 months of HF hospitalization and those randomized after recent outpatient intravenous diuretic therapy. Overall the median MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) risk score in VICTORIA was 23 (IQR 18-27) as compared to the MAGGIC risk score in PARADIGM-HF of 20 (IQR 16-24).
CONCLUSIONS


VICTORIA comprises a broadly generalizable high-risk population of three unique clinical strata of worsening chronic HFrEF despite very good HF therapy. VICTORIA will establish the role of vericiguat, a soluble guanylate cyclase stimulator, in HFrEF.",2019,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","['Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure', '5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event', 'Subjects with Heart Failure with Reduced Ejection Fraction) trial', 'heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial']",['Rivaroxaban'],"['Natriuretic peptides', 'Risk of Death, Myocardial Infarction, or Stroke', 'risk of mortality and rehospitalization', 'glomerular filtration rate', 'atrial fibrillation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",5050.0,0.0885492,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","[{'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Groningen Heart Failure Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1664']
3115,32014273,Impact of inpatient diabetes transitions of care consult on glycemic control.,"OBJECTIVE(S)


An evaluation of a diabetes consult service for hospitalized patients was completed to determine effect on glycemic control.
METHODS


This medical record review was conducted to determine impact of a short-term program on patients with diabetes. The electronic medical record was used to identify patients diagnosed with diabetes mellitus and hospitalized from September 2016 to September 2017. A case-control design was utilized to compare patients with an inpatient order for the diabetes transitions of care service to those receiving usual care. The consultation service consisted of inpatient diabetes education and follow-up post discharge. The HbA1c reduction of adult inpatients those who completed a consult (n = 67) and those who received usual care (n = 67) were compared. Statistical analyses were conducted.
RESULTS


For the primary outcome of HbA1c reduction at 3 months, absolute difference from baseline to 3 months in the intervention was -2.9 % compared to 0.9 % in the control group (p < 0.001).
CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
PRACTICAL IMPLICATIONS


A consult-based diabetes transitions of care service decreased HbA1c versus usual care.",2020,"CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
","['hospitalized patients', 'patients with diabetes', 'patients diagnosed with diabetes mellitus and hospitalized from September 2016 to September 2017', 'adult inpatients those who completed a consult (n\u202f=\u202f67) and those who received usual care (n\u202f=\u202f67', 'patients with an inpatient order for the diabetes transitions of care service to those receiving usual care']",[],['HbA1c reduction'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",[],"[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",67.0,0.0365179,"CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
","[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Powers', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}, {'ForeName': 'Marquita', 'Initials': 'M', 'LastName': 'Winder', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States. Electronic address: marquita.winder@va.gov.'}, {'ForeName': 'MaryAnne', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.010']
3116,31988384,The effects of Ai Chi for balance in individuals with chronic stroke: a randomized controlled trial.,"This study investigated the effectiveness of Ai Chi compared to conventional water-based exercise on balance performance in individuals with chronic stroke. A total of 20 individuals with chronic stroke were randomly allocated to receive either Ai Chi or conventional water-based exercise for 60 min/time, 3 times/week, and a total of 6 weeks. Balance performance assessed by limit of stability (LOS) test and Berg balance scale (BBS). Fugl-Meyer assessment (FMA) and gait performance were documented for lower extremity movement control and walking ability, respectively. Excursion and movement velocity in LOS test was significantly increased in anteroposterior axis after receiving Ai Chi (p = 0.005 for excursion, p = 0.013 for velocity) but not conventional water-based exercise. In particular, the improvement of endpoint excursion in the Ai Chi group has significant inter-group difference (p = 0.001). Both groups showed significant improvement in BBS and FMA yet the Ai Chi group demonstrated significantly better results than control group (p = 0.025). Ai Chi is feasible for balance training in stroke, and is able to improve weight shifting in anteroposterior axis, functional balance, and lower extremity control as compared to conventional water-based exercise.",2020,Both groups showed significant improvement in BBS and FMA yet the Ai Chi group demonstrated significantly better results than control group (p = 0.025).,"['20 individuals with chronic stroke', 'individuals with chronic stroke']","['Ai Chi', 'Ai Chi or conventional water-based exercise', 'conventional water-based exercise']","['Fugl-Meyer assessment (FMA) and gait performance', 'balance performance', 'endpoint excursion', 'Excursion and movement velocity in LOS test', 'Balance performance assessed by limit of stability (LOS) test and Berg balance scale (BBS', 'BBS and FMA']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",20.0,0.0444116,Both groups showed significant improvement in BBS and FMA yet the Ai Chi group demonstrated significantly better results than control group (p = 0.025).,"[{'ForeName': 'Pei-Hsin', 'Initials': 'PH', 'LastName': 'Ku', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Szu-Fu', 'Initials': 'SF', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cheng Hsin General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yea-Ru', 'Initials': 'YR', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ta-Chang', 'Initials': 'TC', 'LastName': 'Lai', 'Affiliation': 'Department of Neurology, Cheng Hsin General Hospital, Taipei, Taiwan, ROC. ch6506@chgh.org.tw.'}, {'ForeName': 'Ray-Yau', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan, ROC. rywang@ym.edu.tw.'}]",Scientific reports,['10.1038/s41598-020-58098-0']
3117,30553026,"Does exercise intensity increment in exergame promote changes in strength, functional capacity and perceptual parameters in pre-frail older women? A randomized controlled trial.","The aim of this study was to compare the effects of two exercise intensities on exergame training program in muscle strength, functional capacity and perceptual parameters in pre-frail older women. Thirty-four women (69.5 ± 5.4 years) were randomly assigned to either moderate- (MG: 11-13 perceived exertion) or vigorous-exercise intensity group (VG: 14-16 perceived exertion). Muscle strength and functional capacity were evaluated before and after 3 months of training. The affective responses were measured once a week and perceived benefit was evaluated after training period. The MG improved the average power at 60°/s from pre- to post-training (p < 0.002) on the knee extensor (pre = 100.0 ± 15.9 W; post = 115.2 ± 22.6 W), flexor (pre = 22.3 ± 6.1 W; post = 29.1 ± 7.9 W) and plantiflexor muscles (pre = 11.4 ± 5.9 W; post = 21.2 ± 4.2 W). MG presented greater average power at post-training than VG for knee extensor (20%) and flexor muscles (23%) (p < 0.039). There was main time effect of peak torque at 180°/s for knee extensor (pre = 74.15 ± 14.28 N·m/kg; post = 81.31 ± 18.4 N·m/kg), flexor (pre = 43.01 ± 12.43 N·m/kg; post = 48.3 ± 9.11 N·m/kg) and plantiflexor muscles (pre = 29.2 ± 13.76 N·m/kg; post = 36.87 ± 9.7 N·m/kg) as well as average power (pre = 41.15 ± 15.67 W; post = 48.42 ± 11.8 W) and work (pre = 99.92 ± 38.53 J; post = 117.03 ± 25.56 J) on the knee flexor muscles (p < 0.046). MG improved timed up and go performance from pre- to post-training (pre = 10.0 ± 0.32 s; post = 8.1 ± 1.6 s, p = 0.001), whereas both groups improved 10 m-walk performance (pre = 1.33 ± 0.25 s, post = 1.5 ± 0.24 s; p = 0.003). Positive affect (2.64 ± 0.02) and pleasure (15.8 ± 0.6) for MG were greater than VG at post-training (2.36 ± 0.03; p < 0.001; 14.4 ± 0.5; p < 0.03). Therefore, regardless of the exercise intensity, exergame training improved muscle strength and functional capacity in pre-frail older women. However, positive affect and pleasure were reported only when older women practiced exergame with moderate exercise intensity.",2019,MG presented greater average power at post-training than VG for knee extensor (20%) and flexor muscles (23%) (p < 0.039).,"['pre-frail older women', 'Thirty-four women (69.5\u202f±\u202f5.4\u202fyears']","['exergame training program', 'moderate', 'vigorous-exercise intensity group']","['muscle strength, functional capacity and perceptual parameters', 'average power', 'peak torque', 'knee flexor muscles', 'flexor muscles', '10\u202fm-walk performance', 'Muscle strength and functional capacity', 'pleasure', 'strength, functional capacity and perceptual parameters', 'muscle strength and functional capacity']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",,0.0815059,MG presented greater average power at post-training than VG for knee extensor (20%) and flexor muscles (23%) (p < 0.039).,"[{'ForeName': 'G O R', 'Initials': 'GOR', 'LastName': 'Santos', 'Affiliation': 'Rua Coração de Maria, 92, BR 116, Km 95, Cep 80210-132 Curitiba, PR, Brazil. Electronic address: gisele.ribeiro21@ufpr.br.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wolf', 'Affiliation': 'Rua Coração de Maria, 92, BR 116, Km 95, Cep 80210-132 Curitiba, PR, Brazil.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Silva', 'Affiliation': 'Rua Coração de Maria, 92, BR 116, Km 95, Cep 80210-132 Curitiba, PR, Brazil.'}, {'ForeName': 'A L F', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Rua Coração de Maria, 92, BR 116, Km 95, Cep 80210-132 Curitiba, PR, Brazil.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Rua Coração de Maria, 92, BR 116, Km 95, Cep 80210-132 Curitiba, PR, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2018.12.009']
3118,31856052,"Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study.","BACKGROUND


Post-operative pain is unpleasant for patients and may worsen surgical recovery. Peri-operative multimodal analgesia has been used for many years; however, its efficacy still needs improvement. In the present study, a thorough peri-operative pain counseling and stratified management program based on risk assessment was implemented, with the goal of improving post-operative analgesia and patient satisfaction.
METHODS


This prospective, controlled, pilot study included 361 patients who underwent elective surgery. Of these 361 patients, 187 received peri-operative pain risk assessment and stratified analgesia and counseling (stratified analgesia group), while 174 received conventional multimodal analgesia (conventional group). The two groups were compared regarding the post-operative pain intensity, rescue analgesia administration, post-operative quality of recovery as assessed via the quality of recovery 40 questionnaire, total dosage of peri-operative opioids, analgesic satisfaction, and analgesic costs.
RESULTS


Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03). The total quality of recovery 40 questionnaire score and the scores for physical wellbeing and pain were significantly better in the stratified analgesia group than the conventional group (P = 0.04); the stratified analgesia group also reported better scores for analgesic satisfaction (P = 0.03) and received lower dosages of opioids (P = 0.03). Analgesic costs were lower in the stratified analgesia group than the conventional group; the cost-effective ratio was 109 in the conventional group and 62 in the stratified analgesia group.
CONCLUSIONS


The analgesic efficacy was improved by the implementation of stratified analgesia based on surgical pain risk assessment and counseling. This stratified analgesia protocol increased the patients' analgesic satisfaction and improved the quality of recovery without increasing healthcare costs. The present findings may help improve the efficacy of peri-operative multimodal analgesia in clinical practice.
CLINICAL TRIAL REGISTRY


NCT02728973; https://clinicaltrials.gov/ct2/show/NCT02728973?term=NCT02728973&draw=2&rank=1.",2019,"Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03).","['361 patients, 187 received peri-operative pain risk assessment and stratified analgesia and counseling (stratified analgesia group), while 174 received', '361 patients who underwent elective surgery']","['conventional multimodal analgesia (conventional group', 'Stratified pain management counseling and implementation']","['post-operative pain intensity, rescue analgesia administration, post-operative quality of recovery as assessed via the quality of recovery 40 questionnaire, total dosage of peri-operative opioids, analgesic satisfaction, and analgesic costs', 'total quality of recovery 40 questionnaire score and the scores for physical wellbeing and pain', 'analgesic satisfaction', 'cost-effective ratio', 'pain intensity', 'Analgesic costs', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",361.0,0.0677428,"Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03).","[{'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': ''}, {'ForeName': 'Ju-Ying', 'Initials': 'JY', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Wen-Jian', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000540']
3119,31921328,"Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding prevalence, infant growth velocity and postpartum weight loss in overweight or obese women: protocol for a randomized controlled trial.","Background


Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced. Obesity rates have been increasing worldwide. Overweight or obese women have lower rates of breastfeeding and face mechanical, psychological and biological difficulties. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women; but there is a lack of evidence on its effectiveness in overweight women. Our purpose is to evaluate a new approach to exclusive breastfeeding counselling based on Carl Rogers' Centred-Client Theory in overweight women, and to examine effects on breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss.
Methods


A two-arm simple randomized controlled trial will be conducted in overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia. The intervention is exclusive breastfeeding counselling based on Rogers' theory but adapted for overweight women; it will be performed during the last month of pregnancy, 24 h after delivery and during early infancy (1 and 3 months postpartum). The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels. Intention to treat analysis will be performed to estimate the effect of the new counselling approach compared to standard management on the prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss.
Discussion


We hypothesize that the intervention will result in an increase in the initiation and maintenance of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery. It is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women.
Trial registration


(UTN)  U1111-1228-9913  February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered.",2020,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","['Overweight or obese women', 'Trial registration\n\n\n(UTN)  U1111-1228-9913  February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered', 'overweight women', 'normal weight women', 'overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia', 'overweight or obese women']","['new approach for exclusive breastfeeding counselling', 'Breastfeeding counselling']","['breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss', 'prolactin and macronutrient levels in breast milk and serum prolactin levels', 'breastfeeding prevalence, infant growth velocity and postpartum weight loss', 'exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4\u2009months after delivery', 'prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0951031,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Aldana-Parra', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Gilma', 'Initials': 'G', 'LastName': 'Olaya', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': '2UCL Great Ormond Street Institute of Child Health, London, UK.'}]",International breastfeeding journal,['10.1186/s13006-019-0249-2']
3120,31994254,Nicotine delivery and users' reactions to Juul compared with cigarettes and other e-cigarette products.,"AIMS


To assess the pharmacokinetic (PK) profile of, and users' reactions to, Juul (59 mg nicotine/ml) as an indication of its therapeutic and dependence potential.
DESIGN


Cross-over, within-subjects study in which participants attended after overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5 minutes. The Juul product used was the version available in the United States that has more nicotine in the e-liquid than the one available in the European Union.
SETTING


Laboratory setting in the United Kingdom.
PARTICIPANTS


Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products.
MEASUREMENTS


At each session, number of puffs taken was counted during the 5-minute product use period and blood samples were taken at baseline and at 2, 4, 6, 8, 10 and 30 minutes after starting smoking/vaping and analysed for nicotine. Participants also monitored their urges to smoke and rated the products on a range of characteristics.
FINDINGS


Juul's PK profile was close to the PK profile of cigarettes [maximum concentration (C max  ) = 20.4 versus 19.2 ng/ml; time to maximum concentration (T max  ) = 4 versus 6 minutes; area under the curve (AUC): 307.9 versus 312.6, respectively]. Compared with other EC products, Juul had shorter T max  [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max  (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084). Compared with other e-cigarette products, it also provided faster reduction of urges to smoke and obtained more favourable subjective ratings.
CONCLUSION


Juul's PK profile and user ratings suggest that it could be more effective than other EC products in helping smokers to quit smoking, but it may also have a higher potential to generate regular use in non-smokers.",2020,"Compared with other EC products, Juul had shorter T max  [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max  (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","['Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products']","['Nicotine', 'Juul (59\xa0mg nicotine/ml', 'overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5\xa0minutes']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],,0.051452,"Compared with other EC products, Juul had shorter T max  [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max  (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pittaccio', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14936']
3121,31856049,First-line atezolizumab plus chemotherapy in treatment of extensive small cell lung cancer: a cost-effectiveness analysis from China.,"BACKGROUND


IMpower 133 trial first confirmed the efficacy and safety of adding atezolizumab or placebo to first-line treatment with chemotherapy in patients with extensive-stage small-cell lung cancer (SCLC). While, overprice limited its broad use in clinical. The aim of this study was to evaluate the cost-effectiveness of atezolizumab plus chemotherapy in treatment of extensive SCLC as first line in China.
METHODS


A Markov model was established by extracting data from the IMpower 133 trial with untreated extensive SCLC patients. Utility values were obtained from published studies, and the costs were acquired from real world and literature. Additionally, sensitivity analyses based on a willingness-to-pay (WTP) threshold were performed to identify the uncertain parameters of Markov model.
RESULTS


Total costs of atezolizumab group were $48,129, while cost of chemotherapy alone was just $12,920 in placebo group. The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs). The cost-effectiveness ratio between atezolizumab combination with chemotherapy and chemotherapy alone was $489,013/QALY in China. The net benefit of placebo group was significantly higher than atezolizumab group. One-way sensitivity analyses highlighted that utilities of the progression-free survival (PFS) and progression disease state in placebo group were the most influential parameter.
CONCLUSIONS


Atezolizumab combination therapy was not more cost-effective than chemotherapy alone at a WTP threshold of $25,929/QALY in China.",2019,The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs).,"['patients with extensive-stage small-cell lung cancer (SCLC', 'extensive small cell lung cancer']","['atezolizumab combination with chemotherapy and chemotherapy', 'atezolizumab or placebo', 'chemotherapy', 'atezolizumab', 'Atezolizumab combination therapy', 'atezolizumab plus chemotherapy', 'placebo']","['progression-free survival (PFS) and progression disease state', 'cost-effective', 'efficacy and safety', 'quality-adjusted life-years (QALYs', 'cost-effectiveness', 'cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0836499,The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs).,"[{'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Li', 'Affiliation': 'The Cancer Center of the First Hospital of Jilin University, Changchun, Jilin 130021, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wen-Qian', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jiu-Wei', 'Initials': 'JW', 'LastName': 'Cui', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000536']
3122,31269409,Use of consumer monitors for estimating energy expenditure in youth.,"The purpose of this study was to compare energy expenditure (EE) estimates from 5 consumer physical activity monitors (PAMs) to indirect calorimetry in a sample of youth. Eighty-nine youth (mean (SD); age, 12.3 (3.4) years; 50% female) performed 16 semi-structured activities. Activities were performed in duplicate across 2 visits. Participants wore a Cosmed K4b 2  (criterion for EE), an Apple Watch 2 (left wrist), Mymo Tracker (right hip), and Misfit Shine 2 devices (right hip; right shoe). Participants were randomized to wear a Samsung Gear Fit 2 or a Fitbit Charge 2 on the right wrist. Oxygen consumption was converted to EE by subtracting estimated basal EE (Schofield's equation) from the measured gross EE. EE from each visit was summed across the 2 visit days for comparison with the total EE recorded from the PAMs. All consumer PAMs estimated gross EE, except for the Apple Watch 2 (net Active EE). Paired  t  tests were used to assess differences between estimated (PAM) and measured (K4b 2 ) EE. Mean absolute percent error (MAPE) was used to assess individual-level error. The Mymo Tracker was not significantly different from measured EE and was within 15.9 kcal of measured kilocalories ( p  = 0.764). Mean percent errors ranged from 3.5% (Mymo Tracker) to 48.2% (Apple Watch 2). MAPE ranged from 16.8% (Misfit Shine 2 - right hip) to 49.9% (Mymo Tracker).  Novelty  Only the Mymo Tracker was not significantly different from measured EE but had the greatest individual error. The Misfit Shine 2 - right hip had the lowest individual error. Caution is warranted when using consumer PAMs in youth for tracking EE.",2020,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"['Youth', 'Eighty-nine youth (mean(SD); age, 12.3(3.4']","['Consumer Monitors', 'wear a Samsung Gear Fit 2 (SG) or a Fitbit Charge 2 (FC']","['Oxygen consumption', 'Mean absolute percent error (MAPE']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",89.0,0.0344607,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"[{'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'LaMunion', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Blythe', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Hibbing', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kaplan', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53211, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Clendenin', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0129']
3123,32004698,Ocular symptoms improvement from intranasal triamcinolone compared with placebo and intranasal fluticasone propionate: A meta-analysis.,"BACKGROUND


Allergic rhinitis is a prevalent disease, which can be classed as seasonal (SAR) or perennial. In addition to nasal symptoms, up to 75% of sufferers experience itching, redness, and tearing of the eyes. Intranasal corticosteroids are effective in controlling the allergic nasal symptoms, and increasing evidence suggests that they also can relieve some of the allergic ocular symptoms.
OBJECTIVE


To evaluate the magnitude of efficacy of triamcinolone acetonide (TAA) compared with placebo or fluticasone propionate (FP) on ocular symptom improvement in patients with SAR.
METHODS


A meta-analysis of summary data from 8 randomized, double- or single-blind trials, assessing mean change in total or individual (tearing, redness, and itching) eye symptoms was conducted. Trials that administered a daily dose of 220 μg TAA vs placebo or 200 μg FP over at least 2 weeks' duration, in patients aged 12 years or older with SAR, were analyzed.
RESULTS


Total eye symptom reduction after 2 weeks was greater with TAA than placebo, with a mean treatment difference of -0.32 (95% CI, -0.444 to -0.203). In addition, significant reductions in tearing, but not itching or redness, were observed after TAA treatment compared with placebo. No significant treatment difference was seen between TAA and FP in total ocular symptoms at any of the time points measured (weeks 1, 2, 3, and overall). All treatments exhibited similar safety profiles and were deemed well tolerated.
CONCLUSION


The meta-analysis demonstrated the positive clinical improvements TAA has on total ocular allergy symptoms, especially tearing, in addition to its recognized nasal symptom efficacy in SAR.",2020,"In addition, significant reductions in tearing, but not itching or redness, were observed following TAA treatment compared with placebo.","['patients with SAR', 'patients aged ≥12 years with SAR were analyzed']","['Intranasal corticosteroids', 'placebo or fluticasone propionate (FP', 'triamcinolone acetonide (TAA', '220 μg TAA vs placebo', 'placebo', 'Placebo and Intranasal Fluticasone Propionate', 'Intranasal Triamcinolone']","['tolerated', 'ocular symptom improvement', 'TAA and FP in total ocular symptoms', 'Total eye symptom reduction', 'Ocular Symptoms Improvement', 'mean change in total or individual (tearing, redness and itching) eye symptoms', 'itching or redness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1175743', 'cui_str': 'Severe acute respiratory syndrome-related coronavirus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",,0.51655,"In addition, significant reductions in tearing, but not itching or redness, were observed following TAA treatment compared with placebo.","[{'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bielory', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, Departments of Medicine and Ophthalmology, Nutley, New Jersey. Electronic address: drlbielory@gmail.com.'}, {'ForeName': 'Gary N', 'Initials': 'GN', 'LastName': 'Gross', 'Affiliation': 'Dallas Allergy and Asthma Center, Dallas, Texas.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Biostatistics Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Melas-Melt', 'Affiliation': 'Biostatistics, Ividata, Levallois-Perret, France.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Lucio', 'Affiliation': 'Consumer Healthcare, Medical Department, Sanofi, São Paulo, Brazil.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.01.012']
3124,30904221,Neurodevelopment of children born very preterm and/or with a very low birth weight: 8-Year follow-up of a nutritional RCT.,"BACKGROUND


Children born very preterm are at risk for cognitive deficits and motor impairment. Enhanced protein intake immediately after very preterm birth has been associated with favorable growth and improved neurodevelopment. It is unknown whether increased protein intake after discharge from the hospital affects long-term neurodevelopment.
OBJECTIVE


The primary objective was to assess neurodevelopment from infancy to 8 years in preterm-born children who received either protein-enriched formula (PDF), standard term formula (TF), or human milk (HM) after discharge. The secondary objective was to assess the correlation between outcomes obtained at 24 months corrected age (CA) and at 8 years.
METHODS


This RCT included 152 children born very preterm (gestational age ≤32 weeks) and/or with a very low birth weight (≤1500 g) of whom 102 were randomly assigned to receive PDF (n = 54) or TF (n = 48) from term age to 6 months CA. A control group of infants fed HM (n = 50) was also included. Neurodevelopmental outcomes were assessed at 24 months CA (cognitive and motor functioning; n = 123) and at 8 years (estimated Full Scale Intelligence Quotient, visual-motor skills, verbal memory, attention, and motor functioning; n = 76).
RESULTS


The PDF and TF groups were not significantly different in neurodevelopmental outcomes. The HM group had a better cognitive score compared with the PDF group: at 24 months CA 92.9 ± 12.5 vs. 105.2 ± 18.6, P < 0.001 and at 8 years 98.1 ± 11.3 vs. 105.8 ± 9.1, P = 0.017 (P = 0.002 and P = 0.080, respectively, after adjustment for parental educational level). Correlations between outcomes at 24 months CA and 8 years were weak: r = 0.35 and r = 0.37 for cognitive and motor outcomes, respectively.
CONCLUSIONS


PDF did not improve long-term neurodevelopmental outcomes as compared with TF. However, these results should be interpreted with caution considering the substantial attrition at follow-up. Furthermore, the correlation between outcomes at different ages was weak, emphasizing the need for long-term follow-up of nutritional intervention studies in preterm-born children.",2019,"The HM group had a better cognitive score compared with the PDF group: at 24 months CA 92.9 ± 12.5 vs. 105.2 ± 18.6, P < 0.001 and at 8 years 98.1 ± 11.3 vs. 105.8 ± 9.1, P = 0.017","['Children born very preterm', 'children born very preterm and/or with a very low birth weight', '152 children born very preterm (gestational age ≤32 weeks) and/or with a very low birth weight (≤1500\xa0g) of whom 102', 'preterm-born children']","['PDF', 'TF', 'protein-enriched formula (PDF), standard term formula (TF), or human milk (HM']","['cognitive score', 'PDF', 'Neurodevelopmental outcomes', 'Full Scale Intelligence Quotient, visual-motor skills, verbal memory, attention, and motor functioning; n\xa0=\xa076', 'long-term neurodevelopmental outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",152.0,0.0750549,"The HM group had a better cognitive score compared with the PDF group: at 24 months CA 92.9 ± 12.5 vs. 105.2 ± 18.6, P < 0.001 and at 8 years 98.1 ± 11.3 vs. 105.8 ± 9.1, P = 0.017","[{'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Ruys', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatrics/Neonatology, Amsterdam, the Netherlands. Electronic address: c.ruys@vumc.nl.""}, {'ForeName': 'Tinka', 'Initials': 'T', 'LastName': 'Bröring', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Medical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Petra E M', 'Initials': 'PEM', 'LastName': 'van Schie', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Rehabilitation Medicine, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van de Lagemaat', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatrics/Neonatology, Amsterdam, the Netherlands.""}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Rotteveel', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatric Endocrinology, Amsterdam, the Netherlands.""}, {'ForeName': 'Martijn J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatric Endocrinology, Amsterdam, the Netherlands.""}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Oostrom', 'Affiliation': ""Amsterdam UMC, Vrije Universiteit Amsterdam, Medical Psychology, Amsterdam, the Netherlands; Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Psychosocial Department, Amsterdam, the Netherlands.""}, {'ForeName': 'Harrie N', 'Initials': 'HN', 'LastName': 'Lafeber', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatrics/Neonatology, Amsterdam, the Netherlands.""}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2018.12.083']
3125,31346813,The Role of Cytotoxic Chemotherapy in Well-Differentiated Gastroenteropancreatic and Lung Neuroendocrine Tumors.,"OPINION STATEMENT


The treatment landscape of well-differentiated neuroendocrine tumors (NETs) has considerably expanded in recent years, and both somatostatin analogs, radiolabeled somatostatin analogs, everolimus, and sunitinib have been incorporated within the therapeutic armamentarium against these malignancies. Even in the context of multiple treatment options available, cytotoxic chemotherapy plays a pivotal role in the management of pancreatic NETs (panNETs), while its activity in midgut carcinoids and lung NETs is still debated. High response rates, ranging from 30 to 70%, have been consistently reported in studies of panNETs investigating streptozotocin-, temozolomide-, or platinum-based regimens, and an unprecedented prolongation of progression-free survival has been recently demonstrated in a prospective, randomized trial of capecitabine and temozolomide in patients with progressive panNETs. As a general principle, cytotoxic chemotherapy appears particularly appropriate in patients with bulky, symptomatic, or rapidly progressing tumors, especially of pancreatic origin, or in the salvage setting of NET patients who have failed alternative therapeutic options. Emerging evidence has also shown the potential efficacy of induction chemotherapy in patients with locally advanced or oligometastatic panNET, but prospective validation is needed before implementation of this approach in routine clinical practice. At present, there is no consensus on adjuvant therapy in pulmonary NETs, and differences between guideline recommendations at this regard mainly stem from the lack of high-level evidence. In the future, the identification of molecular biomarkers of response to chemotherapy might allow better patient preselection, thus leading to improved outcomes.",2019,"In the future, the identification of molecular biomarkers of response to chemotherapy might allow better patient preselection, thus leading to improved outcomes.","['patients with locally advanced or oligometastatic panNET', 'patients with bulky, symptomatic, or rapidly progressing tumors, especially of pancreatic origin, or in the salvage setting of NET patients who have failed alternative therapeutic options', 'patients with progressive panNETs', 'Well-Differentiated Gastroenteropancreatic and Lung Neuroendocrine Tumors']","['Cytotoxic Chemotherapy', 'capecitabine and temozolomide', 'induction chemotherapy', 'cytotoxic chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}]","[{'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]",[],,0.0167625,"In the future, the identification of molecular biomarkers of response to chemotherapy might allow better patient preselection, thus leading to improved outcomes.","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Cives', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': ""Pelle'"", 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Quaresmini', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mandriani', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Silvestris', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""Aldo Moro"", Piazza Giulio Cesare, 11, 70124, Bari, Italy. francesco.silvestris@uniba.it.'}]",Current treatment options in oncology,['10.1007/s11864-019-0669-7']
3126,30176281,Isoflavone supplementation plus combined aerobic and resistance exercise do not change phase angle values in postmenopausal women: A randomized placebo-controlled clinical trial.,"OBJECTIVE


The aim of this study was to evaluate the effect of isoflavone supplementation plus combined exercise protocol on phase angle (PhA) values in postmenopausal women.
METHODS


Thirty postmenopausal women were randomly assigned in a double blind, placebo-controlled clinical trial divided into two groups: 100 mg/day of isoflavone supplementation (n = 16) and 100 mg/day of starch (placebo; n = 14). In addition, both groups performed a combined aerobic and resistance exercise during 10 weeks. Body composition and PhA were evaluated by bioelectrical impedance.
RESULTS


PhA values did not change in the isoflavone group (PRE: 6.7 ± 0.7° to POST: 6.7 ± 0.6°) and in the placebo group (PRE: 7.2 ± 1.0° to POST: 6.8 ± 0.5°); p group = 0.304, p time = 0.227, p group x time interaction = 0.137. Additionally, delta values were not different (0.04 ± 0.5° vs. -0.40 ± 0.99°; p = 0.176) between isoflavone and placebo groups, respectively.
CONCLUSION


We conclude that isoflavone supplementation plus combined aerobic and resistance exercise did not change PhA in postmenopausal women. The patients were part of ClinicalTrials.gov: NCT03008785.",2019,"RESULTS


PhA values did not change in the isoflavone group (PRE: 6.7 ± 0.7° to POST: 6.7 ± 0.6°) and in the placebo group (PRE: 7.2 ± 1.0° to POST: 6.8 ± 0.5°); p group = 0.304, p time = 0.227, p group","['postmenopausal women', 'Thirty postmenopausal women']","['placebo', 'Isoflavone supplementation plus combined aerobic and resistance exercise', 'isoflavone supplementation plus combined aerobic and resistance exercise', 'isoflavone and placebo', 'isoflavone supplementation plus combined exercise protocol', 'isoflavone supplementation (n\u202f=\u202f16) and 100\u202fmg/day of starch (placebo', 'isoflavone', 'combined aerobic and resistance exercise']","['delta values', 'Body composition and PhA']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",30.0,0.653036,"RESULTS


PhA values did not change in the isoflavone group (PRE: 6.7 ± 0.7° to POST: 6.7 ± 0.6°) and in the placebo group (PRE: 7.2 ± 1.0° to POST: 6.8 ± 0.5°); p group = 0.304, p time = 0.227, p group","[{'ForeName': 'Cinthia D', 'Initials': 'CD', 'LastName': 'Barbosa', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Juliene G', 'Initials': 'JG', 'LastName': 'Costa', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Department of Physical Education, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Jéssica S', 'Initials': 'JS', 'LastName': 'Giolo', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Department of Physical Education, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Luana T', 'Initials': 'LT', 'LastName': 'Rossato', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Paula C', 'Initials': 'PC', 'LastName': 'Nahas', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Igor M', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Department of Physical Education, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Jaqueline P', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Department of Physical Education, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Department of Physical Education, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil.'}, {'ForeName': 'Erick P', 'Initials': 'EP', 'LastName': 'de Oliveira', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, MG, Brazil. Electronic address: erick_po@yahoo.com.br.'}]",Experimental gerontology,['10.1016/j.exger.2018.08.007']
3127,32022990,Tacrolimus- versus sirolimus-based immunosuppression after simultaneous pancreas and kidney transplantation: 5-year results of a randomized trial.,"Tacrolimus, the cornerstone immunosuppression after simultaneous pancreas and -kidney (SPK) transplantation, may exert nephrotoxic and diabetogenic effects. We therefore prospectively compared in an open-label, randomized, monocentric, 5-year follow-up study, a tacrolimus- and a sirolimus-based immunosuppressive regimen. Randomization using the block method allowing a blind allocation was done at the time of surgery. All patients received anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil, and steroids. At month 3, tacrolimus was continued or replaced by sirolimus. The primary endpoint was kidney and pancreas graft survival at 1 and 5 years. Fifty patients were included in the final analysis in each group. At 1 year, differences for kidney and pancreas graft survival between sirolimus and tacrolimus were 0% (90% confidence interval -4.61% to 4.61%) and 6% (90% confidence interval -6.32% to 18.32%), respectively. There was no difference in renal and pancreas graft survival at 5 years. Thirty-four patients (68%) in the sirolimus group vs three (6%) in the tacrolimus group needed definitive withdrawal of the study drug. Despite noninferiority of sirolimus compared to tacrolimus for kidney and pancreas graft survival, the high rate of sirolimus discontinuation does not favor its use as cornerstone therapy after SPK transplantation (NCT00693446).",2020,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","['Fifty patients were included in final analysis in each group', 'after simultaneous pancreas and kidney transplantation']","['anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil and steroids', 'sirolimus and tacrolimus', 'Tacrolimus- versus Sirolimus-based immunosuppression', 'sirolimus-based immunosuppressive regimen', 'sirolimus', 'Tacrolimus', 'tacrolimus']","['kidney and pancreas graft survival', 'renal and pancreas graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",50.0,0.0453456,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cantarovich', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Kervella', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Karam', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Dantal', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garandeau', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Houzet', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branchereau', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Delbos', 'Affiliation': ""Laboratoire d'Histocompatibilité, Etablissement Français du Sang, EFS, Pays de la Loire, Nantes, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Guillot-Gueguen', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Renaudin', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Soulillou', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Maryvonne', 'Initials': 'M', 'LastName': 'Hourmant', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15809']
3128,32017253,Effect of curcumin supplementation on disease severity in patients with liver cirrhosis: A randomized controlled trial.,"Recent reports indicated that curcumin had beneficial effects in animal models of liver injury and cirrhosis. Current study aimed to investigate the effects of curcumin supplementation in patients with liver cirrhosis. In this randomized double-blind placebo-controlled trial, 70 patients with liver cirrhosis aged 20-70 years were randomly divided into two groups to receive 1,000 mg/day curcumin (n = 35) or placebo (n = 35) for 3 months. Model for end-stage liver disease (MELD) (i), MELD, MELD-Na, and Child-Pugh scores were used to assess the severity of cirrhosis. Sixty patients (29 in the curcumin group and 31 in the placebo group) completed the study. MELD(i) (15.55 ± 3.78 to 12.41 ± 3.07), MELD (15.31 ± 3.07 to 12.03 ± 2.79), MELD-Na (15.97 ± 4.02 to 13.55 ± 3.51), and Child-Pugh (7.17 ± 1.54 to 6.72 ± 1.31) scores decreased significantly in the curcumin group after 3-month intervention (p < .001, p < .001, p = .001, and p = .051, respectively), whereas they increased significantly in the placebo group (p < .001, p < .001, p < .001, p = .001, respectively). Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-Pugh scores after 3-month intervention (p < .001 for all of them). In this pilot study, beneficial effects of curcumin supplementation were observed in decreasing disease activity scores and severity of cirrhosis in patients with cirrhosis.",2020,"Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-","['patients with liver cirrhosis', 'end-stage liver disease (MELD', 'Sixty patients (29 in the curcumin group and 31 in the placebo group) completed the study', '70 patients with liver cirrhosis aged 20-70\u2009years', 'patients with cirrhosis']","['curcumin supplementation', 'placebo', 'MELD(i']","['MELD(i), MELD, MELD-Na, and Child', 'disease activity scores and severity of cirrhosis', 'i), MELD, MELD-Na, and Child', 'Pugh scores', 'disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",70.0,0.210468,"Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Nouri-Vaskeh', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Malek Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Afshan', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Alizadeh', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zarei', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Perlman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Phytotherapy research : PTR,['10.1002/ptr.6620']
3129,32006293,Embedding a Co-occurring Disorders Rehabilitation Intervention in Veterans Courts: A Pilot Study with Male Veterans.,"Veterans treatment courts (VTCs) have expanded dramatically despite their limited empirical base. This pilot study examined MISSION-Criminal Justice (CJ), a co-occurring disorders wraparound intervention, delivered alongside two VTCs. Baseline data from 26 male veterans enrolled in two VTCs and MISSION-CJ, and 6-month follow-up data for 18 of the 26 veterans, are presented. Veterans on average were 37.5 years old, 85% Caucasian, had significant histories of criminal justice involvement (14.3 lifetime arrests), had an average of 14.7 years of alcohol use and 9.3 years of illicit drug use, and roughly three-quarters reported mental health symptomatology. At 6-month follow-up, veterans demonstrated improvements in behavioral health, substance use, and criminal justice outcomes. This study demonstrated promising preliminary outcomes of MISSION-CJ in VTCs. A randomized controlled trial is a critical next step to examine whether these outcomes remain consistent with a more rigorous design.",2020,"At 6-month follow-up, veterans demonstrated improvements in behavioral health, substance use, and criminal justice outcomes.","['Veterans Courts', 'Veterans on average were 37.5\xa0years old, 85% Caucasian, had significant histories of criminal justice involvement (14.3 lifetime arrests), had an average of 14.7\xa0years of alcohol use and 9.3\xa0years of illicit drug use, and roughly three-quarters reported mental health symptomatology', 'Male Veterans', '26 male veterans enrolled in two VTCs and MISSION-CJ, and 6-month follow-up data for 18 of the 26 veterans, are presented']",['Embedding a Co-occurring Disorders Rehabilitation Intervention'],"['behavioral health, substance use, and criminal justice outcomes']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}]",,0.0322127,"At 6-month follow-up, veterans demonstrated improvements in behavioral health, substance use, and criminal justice outcomes.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Smelson', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA. David.Smelson@umassmed.edu.'}, {'ForeName': 'Ayorkor', 'Initials': 'A', 'LastName': 'Gaba', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pressman', 'Affiliation': 'Bureau of Substance Addiction Services, Massachusetts Department of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kelsey M', 'Initials': 'KM', 'LastName': 'Clary', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Paige M', 'Initials': 'PM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Pinals', 'Affiliation': 'Massachusetts Department of Mental Health, Boston, MA, USA.'}]",Community mental health journal,['10.1007/s10597-020-00565-z']
3130,31914242,"Health Care Hotspotting - A Randomized, Controlled Trial.","BACKGROUND


There is widespread interest in programs aiming to reduce spending and improve health care quality among ""superutilizers,"" patients with very high use of health care services. The ""hotspotting"" program created by the Camden Coalition of Healthcare Providers (hereafter, the Coalition) has received national attention as a promising superutilizer intervention and has been expanded to cities around the country. In the months after hospital discharge, a team of nurses, social workers, and community health workers visits enrolled patients to coordinate outpatient care and link them with social services.
METHODS


We randomly assigned 800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care. The primary outcome was hospital readmission within 180 days after discharge.
RESULTS


The 180-day readmission rate was 62.3% in the intervention group and 61.7% in the control group. The adjusted between-group difference was not significant (0.82 percentage points; 95% confidence interval, -5.97 to 7.61). In contrast, a comparison of the intervention-group admissions during the 6 months before and after enrollment misleadingly suggested a 38-percentage-point decline in admissions related to the intervention because the comparison did not account for the similar decline in the control group.
CONCLUSIONS


In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care. (Funded by the National Institute on Aging and others; ClinicalTrials.gov number, NCT02090426; American Economic Association registry number, AEARCTR-0000329.).",2020,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","['patients with very high use of health care services', 'community health workers visits enrolled patients to coordinate outpatient care and link them with social services', ""800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care"", 'superutilizers,"" patients with very high use of health care services']","[""Coalition's program than among those who received usual care""]","['hospital readmission within 180 days after discharge', 'readmission rates', '180-day readmission rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",800.0,0.0828356,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Annetta', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}]",The New England journal of medicine,['10.1056/NEJMsa1906848']
3131,31626050,Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China.,"BACKGROUND


13-valent pneumococcal conjugate vaccine (PCV13) was licensed in China based on immunologic noninferiority to 7-valent PCV (PCV7). As part of the noninferiority study, immunogenicity and safety of PCV13 administered as a 3- or 2-dose infant series followed by a toddler dose were examined in healthy Chinese infants.
METHODS


Infants (42- to 77-days-old) were randomized to a 3-dose PCV13 or PCV7 infant series administered double-blind at 3, 4 and 5 months or PCV13 administered open-label at 2, 4 and 6 months and a 2-dose open-label series at 3 and 5 months; all subjects received a toddler dose (12 months). Serotype-specific immunoglobulin G (IgG) concentrations were measured 1 month after the infant series and before and after the toddler dose. Opsonophagocytic activity (OPA) was measured in a subset of subjects at each time point. Safety was evaluated.
RESULTS


One month after the infant series, serotype-specific immune responses (IgG ≥ 0.35 µg/mL) were similar for the 2- versus 3-dose schedules, except for serotype 6B, which was significantly lower in the 2-dose group [70.1% in the PCV13 (3, 5 + 12 mo) group vs. 93.2% in the PCV13 (3, 4, 5 + 12 mo) group and 94.7% in the PCV13 (2, 4, 6 + 12 mo) group]. IgG geometric mean concentrations and OPA geometric mean titers trended numerically higher with 3- versus 2-dose schedules. No significant differences in immunogenicity were observed between the 3- versus 2-dose schedules after the toddler dose. PCV13 was well-tolerated across all schedules.
CONCLUSIONS


PCV13 administered as a 3- or 2-dose infant series followed by a toddler dose was immunogenic and well tolerated in healthy Chinese infants and likely protective against PCV13 serotypes; immune responses with a 2-dose schedule were lower for some serotypes.",2019,"One month after the infant series, serotype-specific immune responses (IgG ≥ 0.35 µg/mL) were similar for the 2- versus 3-dose schedules, except for serotype 6B, which was significantly lower in the 2-dose group [70.1% in the PCV13 (3, 5 + 12 mo) group vs. 93.2% in the PCV13 (3, 4, 5 + ","['Infants in China', 'healthy Chinese infants', 'Infants (42- to 77-days-old']","['PCV13', '3-dose PCV13 or PCV7 infant series administered double-blind at 3, 4 and 5 months or PCV13 administered open-label', '13-Valent Pneumococcal Conjugate Vaccine']","['Opsonophagocytic activity (OPA', 'Immunogenicity and Safety', 'serotype-specific immune responses', 'geometric mean titers', 'IgG geometric mean concentrations and OPA', 'Serotype-specific immunoglobulin G (IgG) concentrations', 'immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}]",,0.0570026,"One month after the infant series, serotype-specific immune responses (IgG ≥ 0.35 µg/mL) were similar for the 2- versus 3-dose schedules, except for serotype 6B, which was significantly lower in the 2-dose group [70.1% in the PCV13 (3, 5 + 12 mo) group vs. 93.2% in the PCV13 (3, 4, 5 + ","[{'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'From the Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'From the Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Division of Respiratory Bacterial Vaccines, NIFDC, Beijing, China.'}, {'ForeName': 'Mariano M', 'Initials': 'MM', 'LastName': 'Young', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'John Z', 'Initials': 'JZ', 'LastName': 'Liang', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Inc, Pearl River, New York.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Inc, Pearl River, New York.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Giardina', 'Affiliation': 'Vaccine Clinical Research and Development, Pfizer Inc, Pearl River, New York.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, Pennsylvania.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002458']
3132,31994278,"Ilex paraguariensis, white mulberry and chromium picolinate in patients with pre-diabetes.","AIM


to evaluate if a nutraceutical compound containing Ilex paraguariensis, White Mulberry and Chromium Picolinate can ameliorate glycemic status in patients with pre-diabetes.
METHODS


we enrolled patients with IFG or IGT, not taking other hypoglycemic compounds. Patients were randomized to take placebo or the nutraceutical compound for 3 months, in a randomized, double-blind, placebo-controlled design. Both treatments were self-administered once a day, 1 tablet during the breakfast.
RESULTS


a reduction of FPG was observed with the nutraceutical combination (-7.8%). Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%). M value was higher (p < 0.05 vs baseline and p < 0.05 vs placebo) at the end of the treatment. We obtained a reduction of Tg with the nutraceutical combination (-8.3%). About 16.6% of patients treated with nutraceutical returned to have a normal glycemia (< 100 mg/dL), and all patients had an improvement of insulin-resistance, in particular 67% of patients returned to have a M value inside range of normal insulin sensitivity.
CONCLUSIONS


a nutraceutical containing Ilex paraguariensis, White Mulberry and Chromium Picolinate at 500 mg can be helpful in improving glycemia and Tg value, in patients with pre-diabetes.",2020,"Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%).","['patients with pre-diabetes', 'enrolled patients with IFG or IGT, not taking other hypoglycemic compounds']","['Ilex paraguariensis, white mulberry and chromium picolinate', 'placebo', 'nutraceutical compound containing Ilex paraguariensis, White Mulberry and Chromium Picolinate', 'Chromium Picolinate']","['FPG', 'insulin-resistance', 'normal glycemia', 'M value', 'glycemic status', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}]","[{'cui': 'C0874159', 'cui_str': 'Ilex paraguariensis'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0330540', 'cui_str': 'Mulberry'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.137981,"Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%).","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}]",Phytotherapy research : PTR,['10.1002/ptr.6611']
3133,31991513,High-dose nitroglycerin administered during rewarming preserves erythrocyte deformability in cardiac surgery with cardiopulmonary bypass.,"OBJECTIVE


We aimed to determine whether high-dose nitroglycerin, a nitric oxide donor, preserves erythrocyte deformability during cardiopulmonary bypass and examines the signaling pathway of nitric oxide in erythrocytes.
METHODS


In a randomized and controlled fashion, forty-two patients undergoing cardiac surgery with hypothermic cardiopulmonary bypass were allocated to high-dose (N = 21) and low-dose groups (N = 21). During rewarming period, patients were given intravenous nitroglycerin with an infusion rate 5 and 1 µg·kg -1  ·min -1  in high-dose and low-dose groups, respectively. Tyrosine phosphorylation level of non-muscle myosin IIA in erythrocyte membrane was used as an index of erythrocyte deformability and analyzed using immunoblotting.
RESULTS


Tyrosine phosphorylation of non-muscle myosin IIA was significantly enhanced after bypass in high-dose group (3.729 ± 1.700 folds, P = .011) but not low-dose group (1.545 ± 0.595 folds, P = .076). Phosphorylation of aquaporin 1, vasodilator-stimulated phosphoprotein, and focal adhesion kinase in erythrocyte membrane was also upregulated in high-dose group after bypass. Besides, plasma nitric oxide level was highly correlated with fold change of non-muscle myosin IIA phosphorylation (Pearson's correlation coefficient .871).
CONCLUSIONS


High-dose nitroglycerin administered during cardiopulmonary bypass improves erythrocyte deformability through activating phosphorylation of aquaporin 1, vasodilator-stimulated phosphoprotein, and focal adhesion kinase in erythrocytes.",2020,"RESULTS


Tyrosine phosphorylation of non-muscle myosin IIA was significantly enhanced after bypass in high-dose group (3.729 ± 1.700 folds, p = 0.011) but not low-dose group (1.545 ± 0.595 folds, p = 0.076).","['forty-two patients undergoing cardiac surgery with', 'Cardiac Surgery with Cardiopulmonary Bypass']","['nitroglycerin', 'Nitroglycerin', 'hypothermic cardiopulmonary bypass']","['Tyrosine phosphorylation of non-muscle myosin IIA', 'erythrocyte deformability', 'plasma nitric oxide level', 'Erythrocyte Deformability']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0949646', 'cui_str': 'Myosin A'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte Filterability'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",42.0,0.0646596,"RESULTS


Tyrosine phosphorylation of non-muscle myosin IIA was significantly enhanced after bypass in high-dose group (3.729 ± 1.700 folds, p = 0.011) but not low-dose group (1.545 ± 0.595 folds, p = 0.076).","[{'ForeName': 'Ying-Hsuan', 'Initials': 'YH', 'LastName': 'Tai', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'You-Hsiang', 'Initials': 'YH', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiang-Ling', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Su-Man', 'Initials': 'SM', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Mei-Yung', 'Initials': 'MY', 'LastName': 'Tsou', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Hsiung', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Huang', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Cherng', 'Initials': 'CC', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}]","Microcirculation (New York, N.Y. : 1994)",['10.1111/micc.12608']
3134,30903540,"The Effect of an Intervention Teaching Adolescents that People can Change on Depressive Symptoms, Cognitive Schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones.","Interest is increasing in developing universal interventions to prevent depression in adolescents that are brief enough to be scaled up. The aim of this study was to test the effects on depressive symptoms, cognitive schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones of an intervention focused on teaching an element of an incremental theory of personality, namely, the belief that people can change. We also examined whether grade level moderated the effects of the intervention. A double-blind, randomized, controlled trial was conducted with 867 Spanish adolescent participants (51.9% boys, Grades 8-10) randomly assigned to an incremental theory intervention (n = 456) or an educational control intervention (n = 411). The adolescents completed measures of depressive symptoms and negative cognitive schemas at pretest, at 6-month follow-up, and at 12-month follow-up. A subsample of 503 adolescents provided salivary samples for cortisol and DHEA-S testing. In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S. Moreover, in adolescents who received the intervention, the rate of adolescents with high depression scores decreased by almost 18% whereas in the control group, the rate increased by 37%. Surprisingly, the effects of the intervention were in the opposite direction among adolescents in 9th grade. These data indicate that a brief universal intervention could prevent depressive symptoms under some conditions, but developmental characteristics can moderate the effectiveness of this approach.",2019,"In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S.","['867 Spanish adolescent participants (51.9% boys, Grades 8-10) randomly assigned to an', '503 adolescents provided salivary samples for cortisol and DHEA-S testing']",['incremental theory intervention (n\u2009=\u2009456) or an educational control intervention'],"['depressive symptoms and negative cognitive schemas', 'DHEA-S', 'rate of adolescents with high depression scores', 'depressive symptoms', 'depressive symptoms and cognitive schemas', 'Depressive Symptoms, Cognitive Schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}]",867.0,0.0384538,"In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calvete', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain. esther.calvete@deusto.es.'}, {'ForeName': 'Liria', 'Initials': 'L', 'LastName': 'Fernández-Gonzalez', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Orue', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Ainara', 'Initials': 'A', 'LastName': 'Echezarraga', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Royuela-Colomer', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Cortazar', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muga', 'Affiliation': 'IMQanalisis, 48008, Bilbao, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Longa', 'Affiliation': 'IMQanalisis, 48008, Bilbao, Spain.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas, Austin, TX, 78712, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00538-1']
3135,31314702,Effect of tDCS on Fine Motor Control of Patients in Subacute and Chronic Post-Stroke Stages.,"In this study we compared the effects of transcranial direct current stimulation (tDCS) in the subacute and chronic stages of post-stroke recovery. Anodal/sham tDCS was applied to the primary motor cortex of stroke patients in these stages of recovery in a cross-over design. The Jebsen-Taylor hand function test was employed. The repeated-measure ANOVA showed significant influence of the stimulation type and test performance time (during/after tDCS) with no overall influence of recovery stage. The interaction TYPE*TIME*STAGE was significant. The effect after anodal tDCS in the subacute stage was significantly higher compared to the effects in all relevant conditions including the chronic stage. Therefore, tDCS treatment in the subacute stage of recovery can be superior, at least for some patients, to treatment in the chronic stage.",2020,The effect after anodal tDCS in the subacute stage was significantly higher compared to the effects in all relevant conditions including the chronic stage.,['Patients in Subacute and Chronic Post-Stroke Stages'],"['tDCS', 'anodal tDCS', 'transcranial direct current stimulation (tDCS', 'Anodal/sham tDCS']",['stimulation type and test performance time'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0397536,The effect after anodal tDCS in the subacute stage was significantly higher compared to the effects in all relevant conditions including the chronic stage.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Pavlova', 'Affiliation': 'Department of Clinical Sciences Karolinska Institute, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Semenov', 'Affiliation': 'Moscow Research and Clinical Center for Neuropsychiatry of the Healthcare Department of Moscow, Moscow, Russian Federation.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Guekht', 'Affiliation': 'Moscow Research and Clinical Center for Neuropsychiatry of the Healthcare Department of Moscow, Moscow, Russian Federation.'}]",Journal of motor behavior,['10.1080/00222895.2019.1639608']
3136,31988084,Opportunistic screening versus usual care for diagnosing atrial fibrillation in general practice: a cluster randomised controlled trial.,"BACKGROUND


Atrial fibrillation (AF) increases the risk of stroke, heart failure, and all-cause mortality. AF may be asymptomatic and therefore remain undiagnosed. Devices such as single-lead electrocardiographs (ECGs) may help GPs to diagnose AF.
AIM


To investigate the yield of opportunistic screening for AF in usual primary care using a single-lead ECG device.
DESIGN AND SETTING


A clustered, randomised controlled trial among patients aged ≥65 years with no recorded AF status in the Netherlands from October 2014 to March 2016.
METHOD


Fifteen intervention general practices used a single-lead ECG device at their discretion and 16 control practices offered usual care. The follow-up period was 1 year, and the primary outcome was the proportion of newly diagnosed cases of AF.
RESULTS


In total, 17 107 older people with no recorded AF status were eligible to participate in the study. In the intervention arm, 10.7% of eligible patients ( n  = 919) were screened over the duration of the study year. The rate of newly diagnosed AF was similar in the intervention and control practices (1.43% versus 1.37%,  P  = 0.73). Screened patients were more likely to have comorbidities, such as hypertension (60.0% versus 48.7%), type 2 diabetes (24.3% versus 18.6%), and chronic obstructive pulmonary disease (11.3% versus 7.4%), than eligible patients not screened in the intervention arm. Among patients with newly diagnosed AF in intervention practices, 27% were detected by screening, 23% by usual primary care, and 50% by a medical specialist or after stroke/transient ischaemic attack.
CONCLUSION


Opportunistic screening with a single-lead ECG at the discretion of the GP did not result in a higher yield of newly detected cases of AF in patients aged ≥65 years in the community than usual care. For higher participation rates in future studies, more rigorous screening methods are needed.",2020,"Screened patients were more likely to have comorbidities, such as hypertension (60.0% versus 48.7%), type 2 diabetes (24.3% versus 18.6%), and chronic obstructive pulmonary disease (11.3% versus 7.4%), than eligible patients not screened in the intervention arm.","['17 107 older people with no recorded AF status were eligible to participate in the study', 'patients aged ≥65 years with no recorded AF status in the Netherlands from October 2014 to March 2016', 'patients with newly diagnosed AF in intervention practices, 27% were detected by screening, 23% by usual primary care, and 50% by a medical specialist or after stroke/transient ischaemic attack', 'general practice', 'Fifteen intervention general practices used a']","['Opportunistic screening versus usual care', 'single-lead ECG device at their discretion and 16 control practices offered usual care']","['chronic obstructive pulmonary disease', 'rate of newly diagnosed AF', 'proportion of newly diagnosed cases of AF']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",17107.0,0.164412,"Screened patients were more likely to have comorbidities, such as hypertension (60.0% versus 48.7%), type 2 diabetes (24.3% versus 18.6%), and chronic obstructive pulmonary disease (11.3% versus 7.4%), than eligible patients not screened in the intervention arm.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Kaasenbrood', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}, {'ForeName': 'Steven Hm', 'Initials': 'SH', 'LastName': 'de Bruijn', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}, {'ForeName': 'Carlijn Pe', 'Initials': 'CP', 'LastName': 'Dolmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital Groningen; assistant professor, Department of Cardiology, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X708161']
3137,31989472,The effect of intravenous dexamethasone on postoperative nausea and vomiting after Cesarean delivery with intrathecal morphine: a randomized-controlled trial.,"PURPOSE


Intrathecal morphine administered during spinal anesthesia for Cesarean delivery is associated with a high incidence of postoperative nausea and vomiting (PONV). Small studies performed to date provide conflicting evidence on the effectiveness of dexamethasone as prophylaxis in this setting, raising the possibility that efficacy may be linked to dose timing. This study hypothesized that intravenous dexamethasone given prior to intrathecal morphine during spinal anesthesia may reduce the incidence of PONV.
METHODS


In this double-blind, placebo-controlled trial, 108 patients undergoing Cesarean delivery were randomized to receive 8 mg dexamethasone or placebo prior to spinal anesthesia that included 0.2 mg intrathecal morphine. Outcomes were assessed on postanesthesia care unit arrival, as well as at postoperative hours one, three, six, 24, and 48. The primary outcome was the total number of subjects experiencing PONV during the study period of 48 hr postpartum. Secondary outcomes included severity of pain via the numeric rating scale pain score, and the use of rescue antiemetics and analgesics.
RESULTS


No significant difference in the number of patients experiencing PONV was found between the treatment (n = 44, 80.0%) and control groups (n = 45, 84.9%) (difference -4.9%; 95% confidence interval, -19.2 to 9.4; P = 0.50), nor for median numeric rating scale pain scores (P = 0.24), total consumption of rescue antiemetics (P = 0.40), or opioid analgesics (P = 0.26).
CONCLUSIONS


This trial does not support the use of dexamethasone prior to intrathecal morphine for PONV prophylaxis in Cesarean delivery.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT01734161); registered 27 November, 2012.",2020,"No significant difference in the number of patients experiencing PONV was found between the treatment (n = 44, 80.0%) and control groups (n = 45, 84.9%) (difference -4.9%; 95% confidence interval, -19.2 to 9.4; P = 0.50), nor for median numeric rating scale pain scores (P = 0.24), total consumption of rescue antiemetics (P = 0.40), or opioid analgesics (P = 0.26).
",['108 patients undergoing Cesarean delivery'],"['dexamethasone', 'dexamethasone or placebo prior to spinal anesthesia that included 0.2 mg intrathecal morphine', 'morphine', 'intrathecal morphine', 'placebo']","['total number of subjects experiencing PONV', 'postanesthesia care unit arrival, as well as at postoperative hours one', 'postoperative nausea and vomiting (PONV', 'median numeric rating scale pain scores', 'postoperative nausea and vomiting', 'total consumption of rescue antiemetics', 'severity of pain via the numeric rating scale pain score, and the use of rescue antiemetics and analgesics', 'number of patients experiencing PONV', 'opioid analgesics']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",108.0,0.72799,"No significant difference in the number of patients experiencing PONV was found between the treatment (n = 44, 80.0%) and control groups (n = 45, 84.9%) (difference -4.9%; 95% confidence interval, -19.2 to 9.4; P = 0.50), nor for median numeric rating scale pain scores (P = 0.24), total consumption of rescue antiemetics (P = 0.40), or opioid analgesics (P = 0.26).
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Selzer', 'Affiliation': 'Department of Anesthesiology, University of Colorado, 12401 E 17th Ave, Leprino Building, Mail Stop B113, Aurora, CO, 80045, USA. Angela.Selzer@CUAnschutz.edu.'}, {'ForeName': 'Kane O', 'Initials': 'KO', 'LastName': 'Pryor', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Tangel', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kjaer', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01582-y']
3138,30689727,Improving Dietary Protein Quality Reduces the Negative Effects of Physical Inactivity on Body Composition and Muscle Function.,"BACKGROUND


Brief periods of physical inactivity can compromise muscle health. Increasing dietary protein intake is potentially beneficial but complicated by difficulties reconciling anabolic potential with a realistic food volume and energy intake. We sought to determine whether increasing dietary protein quality could reduce the negative effects of physical inactivity.
METHODS


Twenty healthy, older men and women completed 7 days of bed rest followed by 5 days of rehabilitation. Volunteers consumed a mixed macronutrient diet (MIXED: N = 10; 68 ± 2 years; 1,722 ± 29 kcal/day; 0.97 ± 0.01 g protein/kg/day) or an isoenergetic, whey-augmented, higher protein quality diet (WHEY: N = 10; 69 ± 1 years; 1,706 ± 23 kcal/day; 0.90 ± 0.01 g protein/kg/day). Outcomes included body composition, blood glucose, insulin, and a battery of physical function tests.
RESULTS


During bed rest, both groups experienced a 20% reduction in knee extension peak torque (p < .05). The WHEY diet partially protected leg lean mass (-1,035 vs. -680 ± 138 g, MIXED vs. WHEY; p = .08) and contributed to a greater loss of body fat (-90 vs. -233 ± 152 g, MIXED vs. WHEY; p < .05). Following rehabilitation, knee extension peak torque in the WHEY group fully recovered (-10.0 vs. 2.2 ± 4.1 Nm, MIXED vs. WHEY; p = .05). Blood glucose, insulin, aerobic capacity, and Short Physical Performance Battery (SPPB) changes were similar in both dietary conditions (p > .05).
CONCLUSIONS


Improving protein quality without increasing total energy intake has the potential to partially counter some of the negative effects of bed rest in older adults.",2019,"Blood glucose, insulin, aerobic capacity, and Short Physical Performance Battery (SPPB) changes were similar in both dietary conditions (p > .05).
","['Twenty healthy, older men and women completed 7 days of bed rest followed by 5 days of rehabilitation', 'older adults']",['mixed macronutrient diet (MIXED'],"['loss of body fat', 'knee extension peak torque', 'Body Composition and Muscle Function', 'leg lean mass', 'Blood glucose, insulin, aerobic capacity, and Short Physical Performance Battery (SPPB) changes', 'body composition, blood glucose, insulin, and a battery of physical function tests']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",20.0,0.0279606,"Blood glucose, insulin, aerobic capacity, and Short Physical Performance Battery (SPPB) changes were similar in both dietary conditions (p > .05).
","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Arentson-Lantz', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Elfego', 'Initials': 'E', 'LastName': 'Galvan', 'Affiliation': 'Center for Recovery, Physical Activity and Nutrition, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ellison', 'Affiliation': ""School of Physical Therapy, Texas Woman's University, Houston.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wacher', 'Affiliation': 'Department of Anesthesiology, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Paddon-Jones', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz003']
3139,32199078,Correction to Lancet Infect Dis 2020; published online March 12. https://doi.org/10.1016/S1473-3099(20)30174-2.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30174-2'],[],[],[],[],,0.0188256,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30224-3']
3140,32174033,Comparison of amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS alone: Clinical outcomes at 1-year follow-up.,"Carpal tunnel syndrome (CTS) is the most common focal entrapment mononeuropathy, comprising medium nerve chronic inflammation and fibrosis. Although carpal tunnel release surgery (CTRS) has demonstrated to be effective, around 3% to 25% of CTRS show recurrence. Amniotic membrane transplantation (AMT) has been used in different pathologies inhibiting inflammation and fibrosis and promoting nerve repair. The aim of this study was to determine the efficacy of AMT in CTRS. The present study comprised a randomized, single-blind controlled trial to compare the 1-year follow-up outcomes of AMT in CTRS (AMT group) or CTRS alone (control group) in patients with CTS. Thirty-five patients with unilateral or bilateral CTS were enrolled, and 47 wrists were randomized into two groups: the AMT group and the control group. To compare the outcomes, three different questionnaires scores (Boston Carpal Tunnel Syndrome Questionnaire, Disabilities of the Arm, Shoulder, and Hand, and Historical-Objective scale) were used. Evaluations were assessed at baseline and at 15 days, 1, 3, 6, and 12 months after surgery. Compared with the control group, the AMT group showed significant (p < 0.05) reductions in all scores from 6 months after surgery until the end of the study. Both AMT and control groups showed significant intragroup differences in all scores, since the first month after surgery until the end of the study in comparison with the baseline scores. Taken together, these results indicate that CTRS in conjunction with AMT is more effective than CTRS alone in patients with CTS at 1-year follow-up. Clinical Trial: NCT04075357; Amniotic Membrane in Carpal Tunnel Syndrome.",2020,"Compared with the control group, the AMT group showed significant (p < 0.05) reductions in all scores from 6 months after surgery until the end of the study.","['Thirty-five patients with unilateral or bilateral CTS were enrolled, and 47 wrists', 'Carpal tunnel syndrome (CTS', 'Carpal Tunnel Syndrome', 'patients with CTS']","['amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS', 'AMT in CTRS (AMT group) or CTRS alone (control group', 'Amniotic membrane transplantation (AMT', 'carpal tunnel release surgery (CTRS', 'CTRS', 'AMT']","['questionnaires scores (Boston Carpal Tunnel Syndrome Questionnaire, Disabilities of the Arm, Shoulder, and Hand, and Historical-Objective scale']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0002630', 'cui_str': 'Amniotic Membrane'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0222045'}]",35.0,0.0350404,"Compared with the control group, the AMT group showed significant (p < 0.05) reductions in all scores from 6 months after surgery until the end of the study.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Buentello-Volante', 'Affiliation': 'Amniotic Membrane Tissue Bank, Cell and Tissue Biology, Research Unit, Institute of Ophthalmology, Conde de Valenciana Foundation, Mexico City, Mexico.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Molina-Medinilla', 'Affiliation': 'Traumatology and Orthopaedics Department, ""La Villa"" General Hospital, Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Aguayo-Flores', 'Affiliation': 'Amniotic Membrane Tissue Bank, Cell and Tissue Biology, Research Unit, Institute of Ophthalmology, Conde de Valenciana Foundation, Mexico City, Mexico.'}, {'ForeName': 'Fátima Sofía', 'Initials': 'FS', 'LastName': 'Magaña-Guerrero', 'Affiliation': 'Amniotic Membrane Tissue Bank, Cell and Tissue Biology, Research Unit, Institute of Ophthalmology, Conde de Valenciana Foundation, Mexico City, Mexico.'}, {'ForeName': 'Yonathan', 'Initials': 'Y', 'LastName': 'Garfias', 'Affiliation': 'Amniotic Membrane Tissue Bank, Cell and Tissue Biology, Research Unit, Institute of Ophthalmology, Conde de Valenciana Foundation, Mexico City, Mexico.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.3033']
3141,32148330,Changes in pressure pain threshold and temporal summation in rapid responders and non-rapid responders after lumbar spinal manipulation and sham: A secondary analysis in adults with low back pain.,"BACKGROUND


People with LBP who experience rapid improvement in symptoms after spinal manipulative therapy (SMT) are more likely to experience better longer-term outcomes compared to those who don't improve rapidly. It is unknown if short-term hypoalgesia after SMT could be a relevant finding in rapid responders.
OBJECTIVES


We aimed to explore whether rapid responders had different short-term pressure pain threshold (PPT) and temporal summation (TS) outcomes after SMT and sham compared to non-rapid responders.
METHODS


This was a planned secondary analysis of a randomised controlled trial that recruited 80 adults with LBP (42 females, mean age 37 yrs). PPT at the calf, lumbar spine, and shoulder and TS at the hands and feet were measured before and three times over 30 min after a lumbar SMT or sham manipulation. Participants were classified as rapid responders or non-rapid responders based on self-reported change in LBP over the following 24 h.
RESULTS


Shoulder PPT transiently increased more in the rapid responders than non-rapid responders immediately post-intervention only (between-group difference in change from baseline = 0.29 kg/cm 2 , 95% CI 0.02-0.56, p = .0497). There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
CONCLUSIONS


Hypoalgesia in shoulder PPT occurred transiently in the rapid responders compared to the non-rapid responders. This may or may not contribute to symptomatic improvement after SMT or sham in adults with LBP, and may be a spurious finding. Short-term changes in TS do not appear to be related to changes in LBP.",2020,"There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
","['adults with low back pain', '80 adults with LBP (42 females, mean age 37\xa0yrs']",['spinal manipulative therapy (SMT'],"['calf PPT, lumbar PPT, hand TS, or foot TS based on responder status', 'Hypoalgesia in shoulder PPT', 'LBP', 'Shoulder PPT', 'short-term pressure pain threshold (PPT) and temporal summation (TS) outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0949742', 'cui_str': 'Manipulation Therapy'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}]",80.0,0.268816,"There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark. Electronic address: clyde@health.sdu.dk.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: s.etherington@murdoch.edu.au.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: bruce.walker@murdoch.edu.au.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102137']
3142,32199491,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


The 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301.
FINDINGS


Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504 [49·9%] in the placebo/ChAd3-EBO-Z group), 17 were excluded because no vaccine was administered. The most common solicited injection site symptom was pain (356 [48%] of 748 in the ChAd3-EBO-Z group vs 57 [8%] of 751 in the placebo/ChAd3-EBO-Z group); the most common solicited general adverse event was headache (345 [46%] in the ChAd3-EBO-Z group vs 136 [18%] in the placebo/ChAd3-EBO-Z group). Unsolicited adverse events were reported by 123 (16%) of 749 in the ChAd3-EBO-Z group and 119 (16%) of 751 in the placebo/ChAd3-EBO-Z group. Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group; none were considered vaccination-related. No clinically meaningful thrombocytopenia was reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentration was 900 (95% CI 824-983) in the ChAd3-EBO-Z group. There were no treatment-related deaths.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in adults. Our findings provide a strong basis for future development steps, which should concentrate on multivalent approaches (including Sudan and Marburg strains). Additionally, prime-boost approaches should be a focus with a ChAd3-based vaccine for priming and boosted by a modified vaccinia Ankara-based vaccine.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","['adults in Africa', 'adults', 'Healthy adults (≥18 years', 'study centres in Cameroon, Mali, Nigeria, and Senegal', 'Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504']","['placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'ChAd3-EBO-Z (day 0), or saline placebo']","['unsolicited adverse events', 'solicited local or general adverse events', 'Serious adverse events', 'meaningful thrombocytopenia', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'Unsolicited adverse events', 'safety, reactogenicity, and immunogenicity', 'Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination', 'haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0486729', 'cui_str': 'Ebola virus antibody'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",3030.0,0.541374,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Ake', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Gideon A', 'Initials': 'GA', 'LastName': 'Akintunde', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos & Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Günther', 'Affiliation': 'Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Quintiles, La Défense Cedex, France.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30016-5']
3143,32199492,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


During the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02548078.
FINDINGS


From Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Anti-glycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"['vaccine centre in Mali and a university hospital centre in Senegal', 'Healthy children', 'children younger than 6 years', 'children in Africa', 'children aged 1-17 years', 'paediatric population', '776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the']","['ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT', 'ChAd3-EBO-Z/MenACWY-TT', 'placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'Ebola vaccine']","['clinical symptoms of thrombocytopenia', 'solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'Serious adverse events', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'safety, reactogenicity, and immunogenicity', 'anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination']","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0949896', 'cui_str': 'Zaire Ebola Virus'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.236911,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos and Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Quintiles, La Defense Cedex, France.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30019-0']
3144,31767793,Talazoparib in Patients with a Germline  BRCA -Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial.,"BACKGROUND


In the EMBRACA phase III study (NCT01945775), talazoparib was associated with a significantly prolonged progression-free survival (PFS) compared with physician's choice of chemotherapy (PCT) in germline  BRCA1/2 -mutated HER2-negative advanced breast cancer (ABC). Herein, the safety profile of talazoparib is explored in detail.
MATERIALS AND METHODS


Overall, 412 patients received ≥1 dose of talazoparib ( n  = 286) or PCT ( n  = 126). Adverse events (AEs) were evaluated, including timing, duration, and potential overlap of selected AEs. The relationship between talazoparib plasma exposure and grade ≥3 anemia was analyzed. Time-varying Cox proportional hazard models assessed the impact of dose reductions on PFS. Patient-reported outcomes (PROs) in patients with common AEs and health resource utilization (HRU) were assessed in both treatment arms.
RESULTS


The most common AEs with talazoparib were hematologic (195 [68.2%] patients) and typically occurred within the first 3-4 months of receiving talazoparib. Grade 3-4 anemia lasted approximately 7 days for both arms. Overlapping grade 3-4 hematologic AEs were infrequent with talazoparib. Higher talazoparib exposure was associated with grade ≥3 anemia. Permanent discontinuation of talazoparib due to hematologic AEs was low (<2%). A total of 150 (52.4%) patients receiving talazoparib had AEs associated with dose reduction. Hematologic toxicities were managed by supportive care medication (including transfusion) and dose modifications. Among patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib. After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
CONCLUSION


Talazoparib was associated with superior efficacy, favorable PROs, and lower HRU rate versus chemotherapy in g BRCA -mutated ABC. Toxicities were manageable with talazoparib dose modification and supportive care.
IMPLICATIONS FOR PRACTICE


Talazoparib was generally well tolerated in patients with germline  BRCA -mutated HER2-negative advanced breast cancer in the EMBRACA trial. Common toxicities with talazoparib were primarily hematologic and infrequently resulted in permanent drug discontinuation (<2% of patients discontinued talazoparib due to hematologic toxicity). Hematologic toxicities typically occurred during the first 3-4 months of treatment and were managed by dose modifications and supportive care measures. A significant efficacy benefit, improved patient-reported outcomes, lower rate of health resource utilization and a tolerable safety profile support incorporating talazoparib into routine management of germline  BRCA -mutated locally advanced/metastatic breast cancer.",2019,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
","[' n  =\u2009286) or', 'patients with germline  BRCA -mutated', 'Patients with a Germline  BRCA -Mutated', 'HER2-negative advanced breast cancer', 'Advanced Breast Cancer', 'Overall, 412 patients received ≥1 dose of', 'patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib']","['chemotherapy (PCT', 'Talazoparib', 'PCT', 'talazoparib']","['hematologic', 'hematologic toxicity', 'timing, duration, and potential overlap of selected AEs', 'superior efficacy, favorable PROs, and lower HRU rate', 'Toxicities', 'Hematologic toxicities', 'health resource utilization (HRU', 'talazoparib plasma exposure and grade ≥3 anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",412.0,0.0467122,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California, USA shurvitz@mednet.ucla.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'Kaiser Permanente, Northern California, Vallejo, California, USA.'}, {'ForeName': 'Lida A', 'Initials': 'LA', 'LastName': 'Mina', 'Affiliation': 'MD Anderson Cancer Center, Gilbert, Arizona, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'Rocky Mountain Cancer Centers, Littleton, Colorado, USA.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Blum', 'Affiliation': 'Baylor Sammons Cancer Center Texas Oncology, U.S. Oncology, Dallas, Texas, USA.'}, {'ForeName': 'Jayeta', 'Initials': 'J', 'LastName': 'Chakrabarti', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer, Inc., La Jolla, California, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'DeAnnuntis', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Ruben G W', 'Initials': 'RGW', 'LastName': 'Quek', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}]",The oncologist,['10.1634/theoncologist.2019-0493']
3145,31803945,A Randomized Controlled Trial of an Integrated Alcohol Reduction Intervention in Patients With Hepatitis C Infection.,"BACKGROUND AND AIMS


Hepatitis C virus (HCV) and alcohol use are patient risk factors for accelerated fibrosis progression, yet few randomized controlled trials have tested clinic-based alcohol interventions.
APPROACH AND RESULTS


A total of 181 patients with HCV and qualifying alcohol screener scores at three liver center settings were randomly assigned to the following: (1) medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or (2) SBIRT plus 6 months of integrated colocated alcohol therapy (SBIRT + Alcohol Treatment). The timeline followback method was used to assess alcohol use at baseline and 3, 6, and 12 months. Coprimary outcomes were alcohol abstinence at 6 months and heavy drinking days between 6 and 12 months. Secondary outcomes included grams of alcohol consumed per week at 6 months. Mean therapy hours across 6 months were 8.8 for SBIRT-only and 10.1 for SBIRT + Alcohol Treatment participants. The proportion of participants exhibiting full alcohol abstinence increased from baseline to 3, 6, and 12 months in both treatment arms, but no significant differences were found between arms (baseline to 6 months, 7.1% to 20.5% for SBIRT-only; 4.2% to 23.3% for SBIRT + Alcohol Treatment; P = 0.70). Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT + Alcohol Treatment (85.7% to 42.1%) arms (P = 0.30). Although both arms reduced average grams of alcohol consumed per week from baseline to 6 and 12 months, between-treatment effects were not significant.
CONCLUSIONS


Patients with current or prior HCV infection will engage in alcohol treatment when encouraged by liver medical providers. Liver clinics should consider implementing provider-delivered SBIRT and tailored alcohol treatment referrals as part of the standard of care.",2020,Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT+Alcohol Treatment (85.7% to 42.1%) arms,"['181 patients with HCV and qualifying alcohol screener scores at three liver center settings', 'Conclusion: Patients with current or prior HCV-infection will engage in alcohol treatment when encouraged by liver medical providers', 'patients with hepatitis C infection']","['medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or 2) SBIRT plus six months of integrated co-located alcohol therapy (SBIRT+Alcohol Treatment', 'SBIRT+Alcohol', 'Hepatitis C (HCV) and alcohol', 'integrated alcohol reduction intervention']","['grams of alcohol consumed per week at 6 months', 'alcohol abstinence at 6 months and heavy drinking days', 'proportion of participants exhibiting full alcohol abstinence', 'average grams of alcohol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0678274', 'cui_str': 'Abstinences, Alcohol'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]",181.0,0.0378896,Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT+Alcohol Treatment (85.7% to 42.1%) arms,"[{'ForeName': 'Rae Jean', 'Initials': 'RJ', 'LastName': 'Proeschold-Bell', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Evon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Makarushka', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Keefe', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duke University, Durham, NC.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duke University, Durham, NC.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Garbutt', 'Affiliation': 'Bowles Center for Alcohol Studies, School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Wong', 'Affiliation': 'Division of Clinical Decision Making, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Julius M', 'Initials': 'JM', 'LastName': 'Wilder', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Santanu K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Hodge', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Naggie', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fried', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31058']
3146,31926158,Randomized Trial of an Improved Drainage Strategy Versus Routine Chest Tube After Lung Wedge Resection.,"BACKGROUND


Patients undergoing thoracic lung wedge resection could benefit from tubeless strategies. However, postoperative pneumothorax is a primary limiting factor for such strategies. Accordingly, we evaluated the safety and efficacy of the prophylactic use of an air-extraction catheter as an improved drainage strategy and compared the findings with those for chest tube drainage in patients undergoing thoracic wedge resection.
METHODS


Patients undergoing thoracic wedge resection between August 2017 and October 2018 were enrolled in this single-center, randomized, open-label, noninferiority trial. Patients who received an improved drainage strategy involving the use of a prophylactic air-extraction catheter were randomized to the intervention group, whereas those who underwent routine chest tube drainage were assigned to the control group. Analysis was based on the per-protocol population. The primary outcome was the incidence of pneumothorax on postoperative day 1. Secondary outcomes included patient recovery and related complications, including pleural effusion, lung infection, numeric rating scale score for pain, postoperative chest tube or catheter removal, postoperative hospitalization, and chest tube reinsertion.
RESULTS


A total of 96 patients were randomized. Baseline demographic and clinical characteristics were similar between groups. The incidence of pneumothorax in the intervention and control groups was 10.0% and 9.1%, respectively (noninferiority, P = 1.00). In addition, there were no significant between-group differences in secondary outcomes. A significantly lower pain score was observed in the intervention group (P = .001).
CONCLUSIONS


The improved drainage strategy is not inferior to standard chest tube drainage after thoracic wedge resection and should be popularized.",2020,"A significantly lower pain score was observed in the intervention group (P = 0.001).
","['Patients undergoing thoracic wedge resection between August 2017 and October 2018', 'Ninety-six patients were randomized', 'Patients undergoing thoracic lung wedge resection', 'Patients who received an improved drainage strategy involving the use of a prophylactic air-extraction catheter', 'patients undergoing thoracic wedge resection']","['routine chest tube drainage', 'Drainage Strategy vs Routine Chest Tube after Lung Wedge Resection', 'air-extraction catheter']","['incidence of pneumothorax', 'pain score', 'incidence of pneumothorax on postoperative day 1', 'patient recovery and related complications, including pleural effusion, lung infection, numeric rating scale score for pain, postoperative chest tube/catheter removal, postoperative hospitalization, and chest tube reinsertion', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0396568', 'cui_str': 'Wedge excision of lung (procedure)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0396568', 'cui_str': 'Wedge excision of lung (procedure)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",96.0,0.139142,"A significantly lower pain score was observed in the intervention group (P = 0.001).
","[{'ForeName': 'Jia-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xiang-Peng', 'Initials': 'XP', 'LastName': 'Chu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shao-Min', 'Initials': 'SM', 'LastName': 'Lin', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Run-Ying', 'Initials': 'RY', 'LastName': 'Yu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Ben-Yuan', 'Initials': 'BY', 'LastName': 'Jiang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Ri-Qiang', 'Initials': 'RQ', 'LastName': 'Liao', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Nie', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: 13609777314@163.com.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.11.029']
3147,32077229,Comparison of two different minimally invasive percutaneous nephrostomy sheaths for the treatment of staghorn stones.,"OBJECTIVE


To compare the safety and effectiveness of using a conventional nephrostomy sheath (NS) vs using a new NS with suction and evacuation functions in minimally invasive percutaneous nephrolithotomy (MPCNL) for the treatment of staghorn stones.
PATIENTS AND METHODS


A prospective and randomised study of 60 patients with staghorn stones randomly assigned into two groups of 30 patients. One group underwent MPCNL using conventional NS, whereas the other group underwent MPCNL with suction-evacuation NS (SENS). Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results were collected and analysed.
RESULTS


The patient demographics and stone characteristics were similar amongst the two groups. The SENS group had a significantly lower peak and a significantly lower average renal pelvic pressure (RPP) throughout the procedure. The SENS group was more efficient for stone removal and had a much shorter stone treatment time, a lesser use of the stone extractor, and ultimately a higher stone-free rate (SFR). The effects of a lower RPP and shorter stone treatment time translated into less severe postoperative complications as measured per modified Clavien grade.
CONCLUSION


Using SENS in MPCNL for the treatment of staghorn stones has the advantages of lower RPP, increased effectiveness in stone retrieval, decreased surgery related complications, and an improved SFR.",2020,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","['Sixty patients with staghorn stones', 'staghorn stones']","['conventional nephrostomy sheath versus using a new access sheath with suction and evacuation functions', 'MPCNL with suction-evacuation nephrostomy sheaths (SENS', 'SENS', 'minimally invasive percutaneous nephrolithotomy (MPCNL', 'minimally invasive percutaneous nephrostomy sheaths', 'MPCNL using conventional nephrostomy sheaths (CNS']","['average renal pelvic pressure (RPP', 'Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results', 'patient demographics and stone characteristics', 'stone-free rate (SFR', 'safety and efficacy', 'shorter stone treatment time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332249', 'cui_str': 'Staghorn (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0564457', 'cui_str': 'Nephrostomy, Percutaneous'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0399825,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","[{'ForeName': 'Guibin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiezhao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}]",BJU international,['10.1111/bju.15031']
3148,32073798,"[Androgen receptor inhibitors in prostate cancer: new drugs, but for which patient?]","The results of a recent randomised phase 3 clinical trial show that the androgen receptor antagonist darolutamide improves metastasis-free survival in men with non-metastatic, castration-resistant prostate cancer, compared with placebo. The trial included 1509 men with a prostate-specific antigen doubling time of 10 months or less. Non-metastatic disease was defined as the absence of metastases, using conventional imaging rather than the substantially more sensitive PSMA scans. The effect of darolutamide is similar to that of other androgen inhibitors, such as apalutamide and enzalutamide. The value of the current trial to Dutch clinical practice is limited, as the number of patients with non-metastatic, castration-resistant prostate cancer is low due to the increased use of PSMA scans and the reluctance of urologists to start androgen-deprivation therapy in the absence of metastatic disease.",2019,"The effect of darolutamide is similar to that of other androgen inhibitors, such as apalutamide and enzalutamide.","['prostate cancer', 'men with non-metastatic, castration-resistant prostate cancer', '1509 men with a prostate-specific antigen doubling time of 10 months or less. Non-metastatic disease was defined as the absence of metastases, using conventional imaging rather than the substantially more sensitive PSMA scans']","['placebo', 'androgen receptor antagonist darolutamide', 'Androgen receptor inhibitors']",['metastasis-free survival'],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0441633'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4554312', 'cui_str': 'Androgen receptor antagonist (disposition)'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1509.0,0.04433,"The effect of darolutamide is similar to that of other androgen inhibitors, such as apalutamide and enzalutamide.","[{'ForeName': 'André N', 'Initials': 'AN', 'LastName': 'Vis', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Urologie, Amsterdam.'}, {'ForeName': 'R J A', 'Initials': 'RJA', 'LastName': 'van Moorselaar', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Urologie, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
3149,31385285,Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet-Rich Plasma: Preliminary Clinical Results.,"INTRODUCTION


To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet-rich plasma in the treatment of deep retinal capillary ischemia.
METHODS


The study included 28 eyes of 17 patients aged 15-76 years (mean 37.9 years) who had deep retinal capillary ischemia. Patients who had acute-onset paracentral scotoma in the last 1 month were included in the study between January 2018 and January 2019. The diagnosis of deep retinal capillary ischemia was based on clinical history and typical findings of optical coherence tomography angiography. The eyes were divided into three groups: group 1 (n = 7 eyes) received electromagnetic stimulation alone; group 2 (n = 7 eyes) received electromagnetic stimulation and sub-tenon autologous platelet-rich plasma injection; group 3 had no intervention and served as a control group (n = 14 eyes). The patients underwent ten sessions of electromagnetic stimulation in groups 1 and 2. Sub-tenon autologous platelet-rich plasma injection was performed immediately after the first, fifth, and tenth sessions of electromagnetic stimulation in group 2. The deep retinal capillary density and best corrected visual acuity changes were investigated before and after treatment at the first month.
RESULTS


The mean deep retinal capillary density was 52.0% before electromagnetic stimulation and 56.1% after ten sessions of application in group 1; this improvement was statistically significant (p = 0.01). In the combined treatment group (group 2), the mean deep retinal capillary density was 46.9% before the treatment and 56.5% after the treatment; this increase was also statistically significant (p = 0.01). Statistically significant best corrected visual acuity improvement (p = 0.01) could be achieved only in group 2. The combined treatment was significantly superior (p < 0.01) to treatment with only electromagnetic stimulation regarding best corrected visual acuity and deep retinal capillary density. In the control group (group 3), there was no statistically significant change (p = 0.09) in the mean deep retinal capillary density and best corrected visual acuity.
CONCLUSION


Treatment of the underlying cause is a priority in the treatment of deep retinal capillary ischemia. However, in the acute period, local ischemia treatment is necessary to prevent permanent retinal damage and scotomas. In mild cases, only electromagnetic stimulation, which is non-invasive and easy to use, might have a beneficial effect on deep retinal capillary density. In more severe cases, sub-tenon fresh autologous platelet-rich plasma injection together with electromagnetic stimulation may be more effective in the treatment of local ischemia of the retina in order to augment the response.
FUNDING


The Rapid Service Fees were funded by the Ankara University Tecnopolis Institute.
CLINICAL TRIAL REGISTRATION


titck.gov.tr identifier, 2018-136.",2019,The combined treatment was significantly superior (p < 0.01) to treatment with only electromagnetic stimulation regarding best corrected visual acuity and deep retinal capillary density.,"['28 eyes of 17 patients aged 15-76\xa0years (mean 37.9\xa0years) who had deep retinal capillary ischemia', 'Patients who had acute-onset paracentral scotoma in the last 1\xa0month were included in the study between January 2018 and January 2019']","['electromagnetic stimulation', 'electromagnetic stimulation alone', 'Sub-tenon autologous platelet-rich plasma injection', 'electromagnetic stimulation and sub-tenon autologous platelet-rich plasma injection; group 3 had no intervention and served as a control group', 'retinal electromagnetic stimulation and sub-tenon autologous platelet-rich plasma', 'Electromagnetic Stimulation and Platelet-Rich Plasma']","['corrected visual acuity improvement', 'deep retinal capillary density and best corrected visual acuity changes', 'mean deep retinal capillary density', 'visual acuity and deep retinal capillary density', 'mean deep retinal capillary density and best corrected visual acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0271197', 'cui_str': 'Scotoma, Paracentral'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",,0.0237319,The combined treatment was significantly superior (p < 0.01) to treatment with only electromagnetic stimulation regarding best corrected visual acuity and deep retinal capillary density.,"[{'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Özmert', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Ankara University Technopolis, Ankara, Turkey. drumutarslan@hotmail.com.'}]",Advances in therapy,['10.1007/s12325-019-01040-2']
3150,32164673,"Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial.","Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response. Moreover, prior therapeutic trials have suggested improved outcomes in these patients treated with either sulfamethoxazole/ trimethoprim or doxycycline. These trials have been limited by methodological concerns. This trial addresses the primary hypothesis that long-term treatment with antimicrobial therapy increases the time-to-event endpoint of respiratory hospitalization or all-cause mortality compared to usual care treatment in patients with IPF. We invoke numerous innovative features to achieve this goal, including: 1) utilizing a pragmatic randomized trial design; 2) collecting targeted biological samples to allow future exploration of 'personalized' therapy; and 3) developing a strong partnership between the NHLBI, a broad range of investigators, industry, and philanthropic organizations. The trial will randomize approximately 500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care. The site principal investigator will declare their preferred initial antimicrobial treatment strategy (trimethoprim 160 mg/ sulfamethoxazole 800 mg twice a day plus folic acid 5 mg daily or doxycycline 100 mg once daily if body weight is < 50 kg or 100 mg twice daily if ≥50 kg) for the participant prior to randomization. Participants randomized to antimicrobial therapy will receive a voucher to help cover the additional prescription drug costs. Additionally, those participants will have 4-5 scheduled blood draws over the initial 24 months of therapy for safety monitoring. Blood sampling for DNA sequencing and genome wide transcriptomics will be collected before therapy. Blood sampling for transcriptomics and oral and fecal swabs for determination of the microbiome communities will be collected before and after study completion. As a pragmatic study, participants in both treatment arms will have limited in-person visits with the enrolling clinical center. Visits are limited to assessments of lung function and other clinical parameters at time points prior to randomization and at months 12, 24, and 36. All participants will be followed until the study completion for the assessment of clinical endpoints related to hospitalization and mortality events. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02759120.",2020,Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.,"['patients with idiopathic pulmonary fibrosis (IPF', 'participants in both treatment arms will have limited in-person visits with the enrolling clinical center', 'Idiopathic Pulmonary Fibrosis (CleanUP-IPF', '500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care', 'patients with IPF']","['sulfamethoxazole 800', 'antimicrobial therapy strategy', 'sulfamethoxazole/ trimethoprim or doxycycline', 'doxycycline', 'trimethoprim 160', 'antimicrobial therapy ', 'antimicrobial therapy']","['time-to-event endpoint of respiratory hospitalization or all-cause mortality', 'hospitalization and mortality events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.132871,Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.,"[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. kevin.anstrom@duke.edu.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary Medicine, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Rex H', 'Initials': 'RH', 'LastName': 'Edwards', 'Affiliation': 'Pulmonary Fibrosis Foundation, Chicago, IL, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baucom', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Clausen', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Durheim', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Kirchner', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Oldham', 'Affiliation': 'UC Davis, Pulmonary, Critical Care, and Sleep Medicine, Davis, California, USA.'}, {'ForeName': 'Laurie D', 'Initials': 'LD', 'LastName': 'Snyder', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wilson', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yow', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary Medicine, Weill-Cornell Medical Center, Cornell University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory research,['10.1186/s12931-020-1326-1']
3151,29787288,A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE).,"RATIONALE


This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months.
OBJECTIVES


To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe.
METHODS


Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the ΔEBV-SoC of subjects with a post-bronchodilator FEV 1  improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV 1 , 6-minute-walk distance, and St. George's Respiratory Questionnaire scores.
MEASUREMENTS AND MAIN RESULTS


A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a ΔFEV 1  greater than or equal to 15% (P < 0.001). ΔEBV-SoC at 12 months was statistically and clinically significant: for FEV 1 , 0.106 L (P < 0.001); 6-minute-walk distance, +39.31 m (P = 0.002); and St. George's Respiratory Questionnaire, -7.05 points (P = 0.004). Significant ΔEBV-SoC were also observed in hyperinflation (residual volume, -522 ml; P < 0.001), modified Medical Research Council Dyspnea Scale (-0.8 points; P < 0.001), and the BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index (-1.2 points). Pneumothorax was the most common serious adverse event in the treatment period (procedure to 45 d), in 34/128 (26.6%) of EBV subjects. Four deaths occurred in the EBV group during this phase, and one each in the EBV and SoC groups between 46 days and 12 months.
CONCLUSIONS


Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe. Clinical trial registered with www.clinicaltrials.gov (NCT 01796392).",2018,"ΔEBV-SoC at 12 months was statistically and clinically significant: for FEV 1 , 0.106 L (P < 0.001); 6-minute-walk distance, +39.31 m (P = 0.002); and St. George's Respiratory Questionnaire, -7.05 points (P = 0.004).","['Heterogeneous Emphysema (LIBERATE', 'Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites', '190 subjects (128 EBV and 62 SoC', 'patients with little to no collateral ventilation out to 12 months']","['Zephyr Endobronchial Valve Treatment', 'Zephyr EBV', 'Zephyr Endobronchial Valve (EBV']","['BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index', 'hyperinflation', 'modified Medical Research Council Dyspnea Scale', ""absolute changes in post-bronchodilator FEV 1 , 6-minute-walk distance, and St. George's Respiratory Questionnaire scores"", 'Pneumothorax', 'ΔEBV-SoC of subjects with a post-bronchodilator FEV 1  improvement', 'lung function, exercise tolerance, dyspnea, and quality of life', 'Four deaths', 'ΔEBV-SoC']","[{'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention (morphologic abnormality)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0034380'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",190.0,0.129835,"ΔEBV-SoC at 12 months was statistically and clinically significant: for FEV 1 , 0.106 L (P < 0.001); 6-minute-walk distance, +39.31 m (P = 0.002); and St. George's Respiratory Questionnaire, -7.05 points (P = 0.004).","[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': '1 Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sue', 'Affiliation': ""2 St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': ""2 St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dransfield', 'Affiliation': '3 University of Alabama at Birmingham UAB Lung Health Center, Birmingham, Alabama.'}, {'ForeName': 'Hiram', 'Initials': 'H', 'LastName': 'Rivas-Perez', 'Affiliation': '4 Department of Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wiese', 'Affiliation': '4 Department of Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': '5 Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': '6 Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Momen M', 'Initials': 'MM', 'LastName': 'Wahidi', 'Affiliation': '7 Duke University Medical Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hugo Goulart', 'Initials': 'HG', 'LastName': 'de Oliveira', 'Affiliation': '8 Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Morrissey', 'Affiliation': '9 Division of Pulmonary, Critical Care and Sleep Medicine, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Paulo F G', 'Initials': 'PFG', 'LastName': 'Cardoso', 'Affiliation': '10 Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hays', 'Affiliation': '11 University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Majid', 'Affiliation': '12 Interventional Pulmonology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pastis', 'Affiliation': '13 Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kopas', 'Affiliation': '14 Pulmonary Critical Care and Sleep Medicine Consultants, Houston Methodist, Houston, Texas.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vollenweider', 'Affiliation': '15 Orlando Health Pulmonary and Sleep Medicine Group, Orlando Regional Medical Center, Orlando, Florida.'}, {'ForeName': 'P Michael', 'Initials': 'PM', 'LastName': 'McFadden', 'Affiliation': '16 Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Machuzak', 'Affiliation': '17 Center for Major Airway Diseases, Cleveland Clinic, Cleveland Clinic Foundation, Respiratory Institute, Cleveland, Ohio.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hsia', 'Affiliation': '18 Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles, Torrance, California.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Sung', 'Affiliation': '19 Stanford Hospital and Clinics, Stanford, California.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Jarad', 'Affiliation': '20 University Hospital Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Kornaszewska', 'Affiliation': '21 Department of Cardiothoracic Surgery, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hazelrigg', 'Affiliation': '22 Division of Cardiothoracic Surgery, Department of Surgery, Southern Illinois University School of Medicine, Springfield, Illinois.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': '23 Palo Alto Medical Foundation, El Camino Hospital, Mountain View, California.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': '24 QST Consultations Ltd., Allendale, Michigan.'}, {'ForeName': 'Narinder S', 'Initials': 'NS', 'LastName': 'Shargill', 'Affiliation': '25 Pulmonx Corporation, Redwood City, California; and.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': '26 Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201803-0590OC']
3152,32188697,Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.,"BACKGROUND


Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload.
METHODS


To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging.
RESULTS


The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake.
CONCLUSIONS


Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.",2020,"The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months).","['hemodialysis reduces left ventricular mass', 'patients undergoing hemodialysis', 'Home and Self-Care Satellite Facility Hemodialysis Patients', 'participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility', '99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy']","['sodium profiling or hemodiafiltration', 'low-sodium dialysate (135 mM) or conventional dialysate', 'Low-Sodium versus Conventional Sodium Dialysate', 'dialysate sodium']","['left ventricular mass index by cardiac magnetic resonance imaging', 'Left Ventricular Mass', 'health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake', 'intradialytic hypotension', 'interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake (observable entity)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015349', 'cui_str': 'Extracellular Fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.202177,"The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months).","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Marshall', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand; markrogermarshall@icloud.com.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Department of Renal Medicine, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Ruvin S', 'Initials': 'RS', 'LastName': 'Gabriel', 'Affiliation': 'Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Imad A', 'Initials': 'IA', 'LastName': 'Haloob', 'Affiliation': 'Department of Renal Medicine, Bathurst Base Hospital, New South Wales, Bathurst, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hood', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Irvine', 'Affiliation': 'Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Matheson', 'Affiliation': 'Department of Nephrology, Wellington Hospital, Capital & Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'David O R', 'Initials': 'DOR', 'LastName': 'McGregor', 'Affiliation': 'Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Kannaiyan S', 'Initials': 'KS', 'LastName': 'Rabindranath', 'Affiliation': 'Department of Nephrology, Waikato Hospital, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'John B W', 'Initials': 'JBW', 'LastName': 'Schollum', 'Affiliation': 'Nephrology Service, Dunedin Hospital, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Semple', 'Affiliation': 'Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Zhengxiu', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Middlemore Clinical Trials, Auckland, New Zealand; and.'}, {'ForeName': 'Tian Min', 'Initials': 'TM', 'LastName': 'Ma', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand; markrogermarshall@icloud.com.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Sisk', 'Affiliation': 'Division of Informatics, Imaging & Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Dunlop', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019090877']
3153,32154928,"NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma.","BACKGROUND


Targeting vascular endothelial growth factor (VEGF) alone does not improve overall survival (OS) in recurrent glioblastoma (rGBM). The angiopoiein (Ang)-TIE2 system may play a role in tumor survival under VEGF inhibition. We conducted a phase 2, double-blinded, placebo-controlled trial of bevacizumab plus trebananib (a novel Fc fusion protein that sequesters Ang1/Ang2) over bevacizumab alone in rGBM.
METHODS


Patients ≥18 years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse were randomized to bevacizumab 10 mg/kg every 2 weeks plus trebananib 15 mg/kg every week or bevacizumab plus placebo. The primary endpoint was 6-month progression-free survival (PFS).
RESULTS


After an initial 6-patient lead-in cohort confirmed the safety of combining bevacizumab and trebananib, 115 eligible patients were randomized to the control (n = 58) or experimental treatment (n = 57). In the control arm, 6-month PFS was 41.1%, median survival time was 11.5 months (95% CI, 8.4-14.2 months), median PFS was 4.8 months (95% CI, 3.8-7.1 months), and radiographic response (RR) was 5.9%. In the experimental arm, 6-month PFS was 22.6%, median survival time was 7.5 months (95% CI, 6.8-10.1 months), median PFS was 4.2 months (95% CI, 3.7-5.6 months), and RR was 4.2%. The rate of severe toxicities was not significantly different between arms.
CONCLUSION


The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone. The shorter PFS in the experimental arm with a hazard ratio of 1.51 (P = .04) suggests that the addition of trebananib to bevacizumab is detrimental.",2020,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","['patients with recurrent glioblastoma or gliosarcoma', '115 eligible patients', 'Patients ≥18\xa0years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse']","['bevacizumab plus trebananib', 'bevacizumab 10\xa0mg/kg every 2\xa0weeks plus trebananib 15\xa0mg/kg every week or bevacizumab plus placebo', 'placebo', 'bevacizumab with and without trebananib', 'bevacizumab', 'bevacizumab and trebananib', 'angiopoiein']","['radiographic response (RR', '6-month PFS rate, PFS, or OS', 'overall survival (OS', 'rate of severe toxicities', 'shorter PFS', 'median survival time', '6-month progression-free survival (PFS', '6-month PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0206726', 'cui_str': 'Sarcomatous Glioma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",115.0,0.680496,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","[{'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Gerstner', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'deGroot', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pan', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Lyndon J', 'Initials': 'LJ', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'H Ian', 'Initials': 'HI', 'LastName': 'Robins', 'Affiliation': 'University of Wisconsin Hospital and Clinics, Madison, Wisconsin.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Connelly', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Battiste', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Wagle', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Merrell', 'Affiliation': 'North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Merideth M', 'Initials': 'MM', 'LastName': 'Wendland', 'Affiliation': 'The US Oncology Network-Willamette Valley Cancer Institute, Eugene, Oregon.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, Florida.'}]",Cancer,['10.1002/cncr.32811']
3154,31762155,Coronally advanced flap with connective tissue graft or xenogeneic acellular dermal matrix in the treatment of multiple gingival recessions: A split-mouth randomized clinical trial.,"OBJECTIVE


To evaluate the clinical efficacy of xenogeneic acellular dermal matrix (XADM) or connective tissue graft (CTG) combined with modified-coronally advanced flap (M-CAF) in the treatment of multiple gingival recessions.
MATERIALS AND METHODS


Twelve participants with bilateral MGRs (multiple gingival recession) (82 gingival recessions) randomly received XADM (test group, 41 teeth) on one side and subepithelial CTG (control group, 41 teeth) on the other side in conjunction with M-CAF in the same session and completed the 18-months study period. Recession depth (RD), recession width (RW), keratinized tissue width (KTW), probing depth (PD), and clinical attachment level (CAL) were recorded at baseline, and 6-, 18-months postoperatively.
RESULTS


PD was significantly higher in the test group at 18-months (P < .05). PD in the test group was also significantly higher at 6- and 18-months compared to baseline (P < .05). RD and RW were significantly lower at 6- and 18-months compared to baseline in both groups (P < .05) and both parameters were significantly higher in the test group at 18-months (P < .05). Percentage of teeth with complete root coverage in the test and control groups were similar at 6-months (78% and 70.7%, respectively) and at 18-months (both 87.8%) (P > .05).
CONCLUSION


Within the limits of the study, M-CAF combined with XADM or CTG seems to be similarly effective in RD reduction of class I and II MGRs at least in the short term. Soft tissue shrinkage and increase in PD may be observed with XADM, while; CTG seems to provide stable clinical outcomes for 18-months follow-up.
CLINICAL SIGNIFICANCE


Even though the CTG and XADM in conjunction with M-CAF may provide similar RD reduction in class I and II multiple gingival recessions in the short term. CTGs may be superior in terms of soft tissue shrinkage and PD values.",2020,RD and RW were significantly lower at 6- and 18-months compared to baseline in both groups (P < .05) and both parameters were significantly higher in the test group at 18-months (P < .05).,"['Twelve participants with bilateral MGRs (multiple gingival recession) (82 gingival recessions) randomly received', 'multiple gingival recessions']","['xenogeneic acellular dermal matrix (XADM) or connective tissue graft (CTG) combined with modified-coronally advanced flap (M-CAF', 'XADM or CTG', 'side and subepithelial CTG (control group, 41 teeth) on the other side in conjunction with M-CAF', 'Coronally advanced flap with connective tissue graft or xenogeneic acellular dermal matrix', 'XADM']","['RD reduction of class', 'RD and RW', 'Recession depth (RD), recession width (RW), keratinized tissue width (KTW), probing depth (PD), and clinical attachment level (CAL', 'PD', 'Percentage of teeth with complete root coverage', 'Soft tissue shrinkage and increase in PD']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}]","[{'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",12.0,0.0226828,RD and RW were significantly lower at 6- and 18-months compared to baseline in both groups (P < .05) and both parameters were significantly higher in the test group at 18-months (P < .05).,"[{'ForeName': 'Önder', 'Initials': 'Ö', 'LastName': 'Gürlek', 'Affiliation': 'Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Gümüş', 'Affiliation': 'Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Nejat', 'Initials': 'N', 'LastName': 'Nizam', 'Affiliation': 'Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Buduneli', 'Affiliation': 'Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12547']
3155,31055663,New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data.,"PURPOSE


Few retrospective studies have addressed Modic changes (MC) following lumbar spine surgery, though it is usually assumed that MC increase in grade and incidence. To test this conventional wisdom, we investigated the natural course of MC following primary lumbar limited discectomy with two-year follow-up. In addition, a possible clinical relevance to those changes was assessed.
METHODS


The data of the control group (278 subjects) of a prospective randomized, controlled trial (RCT) were evaluated retrospectively.
RESULTS


We did not observe a simple increase in MC with regard to grade. There is variable activity observed in Type 2 (at 12 months) and in Type 1 (at 24 months). Conversion from one grade to another may occur and may be upward or downward. The incidence of MC increased slightly over time, as after surgery a decreasing percentage of the study group remained without MC over two years (1 year: 34% (85/250); 2 years: 30% (72/237)). Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes. Lastly, we found that neither the different MC types nor their changes were correlated with clinical parameters (VAS back, VAS leg, ODI score) preoperatively or during follow-up.
CONCLUSION


The pattern of Modic changes following lumbar limited discectomy is complex, not simply increasing. There is variable activity in MC Types 1 and 2 at the different time points of follow-up, and conversion from a higher grader to a lower one or vice versa is possible. These slides can be retrieved under Electronic Supplementary Material.",2019,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.",[],[],"['incidence of MC', 'clinical parameters (VAS back, VAS leg, ODI score', 'Radiological parameters (rotation, translation, and spondylolisthesis']",[],[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0038016', 'cui_str': 'Spondylisthesis'}]",,0.0423849,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany. richard.bostelmann@med.uni-duesseldorf.de.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Petridis', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Katinka', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Mathematical Institute, Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Barth', 'Affiliation': 'Department of Neurosurgery, Klinikum Frankfurt Höchst, Frankfurt, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05988-1']
3156,31812184,Efficacy of the Enquiring About Tolerance (EAT) study among infants at high risk of developing food allergy.,"BACKGROUND


The Enquiring About Tolerance (EAT) study was a randomized trial of the early introduction of allergenic solids into the infant diet from 3 months of age. The intervention effect did not reach statistical significance in the intention-to-treat analysis of the primary outcome.
OBJECTIVE


We sought to determine whether infants at high risk of developing a food allergy benefited from early introduction.
METHODS


A secondary intention-to-treat analysis was performed of 3 groups: nonwhite infants; infants with visible eczema at enrollment, with severity determined by SCORAD; and infants with enrollment food sensitization (specific IgE ≥0.1 kU/L).
RESULTS


Among infants with sensitization to 1 or more foods at enrollment (≥0.1 kU/L), early introduction group (EIG) infants developed significantly less food allergy to 1 or more foods than standard introduction group (SIG) infants (SIG, 34.2%; EIG, 19.2%; P = .03), and among infants with sensitization to egg at enrollment, EIG infants developed less egg allergy (SIG, 48.6%; EIG, 20.0%; P = .01). Similarly, among infants with moderate SCORAD (15-<40) at enrollment, EIG infants developed significantly less food allergy to 1 or more foods (SIG, 46.7%; EIG, 22.6%; P = .048) and less egg allergy (SIG, 43.3%; EIG, 16.1%; P = .02).
CONCLUSION


Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment. This efficacy occurred despite low adherence to the early introduction regimen. This has significant implications for the new national infant feeding recommendations that are emerging around the world.",2019,Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment.,"['infant diet from 3\xa0months of age', 'A secondary intention-to-treat analysis was performed of 3 groups: nonwhite infants; infants with visible eczema at enrollment, with severity determined by SCORAD; and infants with enrollment food sensitization (specific IgE ≥0.1 kU/L', 'infants at high risk of developing food allergy', 'infants at high risk of developing a food allergy benefited from early introduction']",['Enquiring About Tolerance (EAT'],"['food allergy to 1 or more foods', 'egg allergy', 'food allergy']","[{'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0559469', 'cui_str': 'Egg Hypersensitivity'}]",,0.19238,Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment.,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Benaroya Research Institute, Seattle, Wash.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, Faculty of Life Sciences & Medicine, King's College, London, United Kingdom.""}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Mills', 'Affiliation': 'School of Biological Sciences, Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, Manchester Institute of Biotechnology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Versteeg', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Ree', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands; Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom. Electronic address: gideon.lack@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.045']
3157,31760780,Associations between Self-Reported Daily Affect Ratings and Sleep Duration during the First Two Weeks of Antidepressant Therapy.,"Background : In the context of a randomized controlled trial evaluating the efficacy of augmenting fluoxetine treatment in young adults with major depressive disorder (MDD) using a modified repeated partial sleep deprivation protocol contrasting 2 weeks of restricted time in bed (i.e., 6 h TIB) to no time in bed restriction (i.e., 8 h TIB) the study examines whether sleep duration and the timing of repeated partial sleep deprivation predicts patient-reported affect ratings. Participants : Participants included 58 young adults with DSM-IV-diagnosed MDD. Methods : Daily ratings of affect and sleep were collected during the first 2 weeks of initiating fluoxetine treatment, yielding 630 person-days. Actigraphy monitoring was employed to assess compliance with time in bed condition. Results : Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group. Participants whose bedtime was delayed by 2-h nightly demonstrated the most significant improvement in negative affect and positivity ratio during the first 2 weeks of fluoxetine therapy. Moreover, the trajectory of morning negative affect ratings in the first 2 weeks was predictive of remission after 4 weeks of fluoxetine therapy. Conclusions : These findings suggest that monitoring changes in daily affect may be a valuable marker of early treatment response in young adults with MDD.",2019,Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group.,"['Participants included 58 young adults with DSM-IV-diagnosed MDD', 'young adults with major depressive disorder (MDD', 'Participants ', 'young adults with MDD']","['fluoxetine', ' ']","['Negative affect ratings and positivity ratios', 'negative affect and positivity ratio', 'Daily ratings of affect and sleep']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",58.0,0.0203169,Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group.,"[{'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huntley', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Giselle E', 'Initials': 'GE', 'LastName': 'Kolenic', 'Affiliation': ""Program on Women's Health Care Effectiveness Research, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA.""}, {'ForeName': 'Holli', 'Initials': 'H', 'LastName': 'Bertram', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1695617']
3158,32089356,Strategies to Improve Recruitment to a De-escalation Trial: A Mixed-Methods Study of the OPTIMA Prelim Trial in Early Breast Cancer.,"AIMS


De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them.
MATERIALS AND METHODS


A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a 'plan of action' to optimise recruitment.
RESULTS


Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. 'Tips' documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet.
CONCLUSIONS


This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.",2020,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","['Early Breast Cancer', 'patients with early stage breast cancer to']","[""chemotherapy versus 'test-directed' chemotherapy"", 'mixed-methods recruitment intervention (QuinteT Recruitment Intervention']",[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",[],,0.0681037,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Conefrey', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK. Electronic address: carmel.conefrey@bristol.ac.uk.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Stein', 'Affiliation': 'National Institute for Health Research, University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paramasivan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bartlett', 'Affiliation': 'Ontario Institute for Cancer Research, Toronto, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Harmer', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hughes-Davies', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Macpherson', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pinder', 'Affiliation': ""King's College London, Comprehensive Cancer Centre at Guy's Hospital, London, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Arden Cancer Centre, University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'School of Cancer Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.01.029']
3159,31087164,Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses.,"PURPOSE


The purpose of this study is to establish a new method to reduce the radiation dose during puncture and cannulation in percutaneous endoscopic lumbar discectomy (PELD).
METHODS


Sixty patients with lumbar disk herniation undergoing PELD were prospectively enrolled and randomly divided into an ultrasound (US) guidance group and an X-ray guidance group. The puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose were recorded in both groups. The factors influencing the operation were analyzed. The clinical effect of PELD was evaluated using the straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI). The researchers who collected and analyzed the data were blinded to the group assignments.
RESULTS


The puncture, cannulation and operation times in the US group were comparable to those in the X-ray group. The patients in the US group received 2.13 ± 0.35 fluoroscopy shots and a radiation dose of 5.34 ± 0.63 (mSV), which were significantly lower than the values in the X-ray group (7.57 shots ± 2.99 shots and 18.25 mSV ± 10.52 mSV) (P < 0.001). In the US group, the puncture time was significantly longer at the L5-S1 level, in patients with a BMI greater than 28 kg/m 2  and in patients with a high iliac crest. The US and X-ray groups had comparable VAS and ODI scores 1 h and 3 months after PELD, and the VAS scores were significantly lower after PELD (all P < 0.001). No complications were observed in either group.
CONCLUSIONS


US guidance is a new method that reduces the radiation dose required during puncture and cannulation in PELD. These slides can be retrieved under Electronic Supplementary Material.",2019,The US and X-ray groups had comparable VAS and ODI scores,['Sixty patients with lumbar disk herniation undergoing PELD'],"['ultrasound (US) guidance group and an X-ray guidance group', 'percutaneous endoscopic lumbar discectomy (PELD', 'Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy']","['VAS and ODI scores', 'puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose', 'VAS scores', 'puncture time', 'puncture, cannulation and operation times', 'straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",60.0,0.0167607,The US and X-ray groups had comparable VAS and ODI scores,"[{'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Pain, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shoupeng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, General Hospital of Chinese PLA, No. 28, Fuxing Road, Haidian District, Beijing, 100853, China. harryhp@vip.sina.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05980-9']
3160,32151752,Combined intervention approaches for initiating and maintaining physical activity in depressed individuals: design and rationale of the Project MOVE randomized clinical trial.,"INTRODUCTION


Regular engagement in physical activity decreases risks for many chronic conditions, and may also improve depression symptoms. However, rates of physical activity and adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
METHODS


This is a study protocol for Project MOVE. This study is a theoretically-driven, 3-arm randomized controlled trial for increasing physical activity with depressed adults. Each successive arm includes an added component that may serve to increase and maintain physical activity. The arms are: 1) Brief advice (BA) to exercise alone (minimal treatment control condition); 2) BA + supervised and home-based exercise (SHE) + health education (HE; serves as contact control for CBEX); and 3) BA + SHE +cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX). The target sample size is 240. Assessments are conducted at baseline, Month 1.5, end of intervention (month 3), and at 6 and 9 months. The primary outcome is minutes of moderate-to-vigorous physical activity, assessed via an accelerometer. Secondary outcomes include cardiorespiratory fitness, body composition, and depression, and maintenance of moderate-vigorous physical activity through 6 and 9 month follow-ups. Mediators and moderators derived from behavior change theories, including the Health Behavior Model, Self-Determination Theory, and Social Ecological Theory, will be examined.
CONCLUSION


Project MOVE is designed to test primarily whether both a structured exercise program (SHE) and a cognitive-behavioral group (CBEX) increase physical activity in depressed adults during both a 3-month intervention period, and during the 6-months that follow.",2020,"However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
","['adults with depression', 'depressed individuals']","['regular exercise regimen: 1) brief advice (BA) to exercise only; 2) BA + supervised and home-based exercise (SHE)\u202f+\u202fcognitive behavioral sessions (CBEX); and BA+SHE + health education (HE', 'BA + SHE + CBEX']","['cardiorespiratory fitness, body composition, and depression, and maintenance of MVPA through 6 and 9\u202fmonth follow-ups', 'MVPA levels', 'minutes of moderate-to-vigorous physical activity (MVPA), objectively assessed by accelerometry data', 'rates of PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0418878', 'cui_str': 'Advice to exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018701'}, {'cui': 'C2724208', 'cui_str': '++'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",,0.0680391,"However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Sillice', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA. Electronic address: marie_sillice@brown.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Epstein-Lubow', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Department of Health Services, Policy and Practice of Brown University, Providence, RI, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Battle', 'Affiliation': ""Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Center for Women's Behavioral Health, Women & Infants' Hospital of Rhode Island, Providence, RI, USA.""}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Caviness', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105974']
3161,31335651,"Somatosensory predictors of response to pregabalin in painful chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled, crossover study.","Painful chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and treatment-resistant sequela of many chemotherapeutic medications. Ligands of α2δ subunits of voltage-gated Ca channels, such as pregabalin, have shown efficacy in reducing mechanical sensitivity in animal models of neuropathic pain. In addition, some data suggest that pregabalin may be more efficacious in relieving neuropathic pain in subjects with increased sensitivity to pinprick. We hypothesized that greater mechanical sensitivity, as quantified by decreased mechanical pain threshold at the feet, would be predictive of a greater reduction in average daily pain in response to pregabalin vs placebo. In a prospective, randomized, double-blinded study, 26 patients with painful CIPN from oxaliplatin, docetaxel, or paclitaxel received 28-day treatment with pregabalin (titrated to maximum dose 600 mg per day) and placebo in crossover design. Twenty-three participants were eligible for efficacy analysis. Mechanical pain threshold was not significantly correlated with reduction in average pain (P = 0.97) or worst pain (P = 0.60) in response to pregabalin. There was no significant difference between pregabalin and placebo in reducing average daily pain (22.5% vs 10.7%, P = 0.23) or worst pain (29.2% vs 16.0%, P = 0.13) from baseline. Post hoc analysis of patients with CIPN caused by oxaliplatin (n = 18) demonstrated a larger reduction in worst pain with pregabalin than with placebo (35.4% vs 14.6%, P = 0.04). In summary, baseline mechanical pain threshold tested on dorsal feet did not meaningfully predict the analgesic response to pregabalin in painful CIPN.",2019,Mechanical pain threshold was not significantly correlated with reduction in average pain (P = 0.97) or worst pain (P = 0.60) in response to pregabalin.,"['painful chemotherapy-induced peripheral neuropathy', '26 patients with painful CIPN from']","['oxaliplatin, docetaxel, or paclitaxel received 28-day treatment with pregabalin', 'placebo', 'pregabalin and placebo', 'oxaliplatin', 'pregabalin', 'Painful chemotherapy-induced peripheral neuropathy (CIPN']","['average pain', 'worst pain', 'analgesic response', 'neuropathic pain', 'mechanical sensitivity', 'Mechanical pain', 'mechanical pain', 'average daily pain']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",23.0,0.161168,Mechanical pain threshold was not significantly correlated with reduction in average pain (P = 0.97) or worst pain (P = 0.60) in response to pregabalin.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hincker', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Frey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Rao', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, United States.'}, {'ForeName': 'Manik', 'Initials': 'M', 'LastName': 'Amin', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, United States.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wildes', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Pall', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Bakos', 'Affiliation': 'Investigation Drug Service, Department of Pharmacy, Barnes-Jewish Hospital, Saint Louis, MO, United States.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kosicka', 'Affiliation': 'Department of Physical Pharmacy and Pharmacokinetics, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Kagan', 'Affiliation': 'Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ, United States.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Haroutounian', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO, United States.'}]",Pain,['10.1097/j.pain.0000000000001577']
3162,31452311,Haemoconcentration during treatment of acute heart failure with cardiorenal syndrome: from the CARRESS-HF trial.,,2019,,['acute heart failure with cardiorenal syndrome'],['Haemoconcentration'],[],"[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C2242703', 'cui_str': 'Renocardiac Syndrome'}]","[{'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}]",[],,0.0425089,,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blumer', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Bart', 'Affiliation': 'Division of Cardiology, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Cardiology, The Permanente Medical Group, San Francisco, CA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}]",European journal of heart failure,['10.1002/ejhf.1592']
3163,31122994,Effects of brain training on brain blood flow (The Cognition and Flow Study-CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia.,"INTRODUCTION


Cognitive training is an emerging non-pharmacological treatment to improve cognitive and physical function in mild cognitive impairment (MCI) and early Alzheimer's disease (AD). Abnormal brain blood flow is a key process in the development of cognitive decline. However, no studies have explored the effects of cognitive training on brain blood flow in dementia. The primary aim of this study is to assess the feasibility for a large-scale, randomised controlled trial of cognitive training in healthy older adults (HC), MCI and early AD.
METHODS AND ANALYSIS


This study will recruit 60 participants, in three subgroups of 20 (MCI, HC, AD), from primary, secondary and community services. Participants will be randomised to a 12-week computerised cognitive training programme (five × 30 min sessions per week), or waiting-list control. Participants will undergo baseline and follow-up assessments of: mood, cognition, quality of life and activities of daily living. Cerebral blood flow will be measured at rest and during task activation (pretraining and post-training) by bilateral transcranial Doppler ultrasonography, alongside heart rate (3-lead ECG), end-tidal CO 2  (capnography) and beat-to-beat blood pressure (Finometer). Participants will be offered to join a focus group or semistructured interview to explore barriers and facilitators to cognitive training in patients with dementia. Qualitative data will be analysed using framework analysis, and data will be integrated using mixed methods matrices.
ETHICS AND DISSEMINATION


Bradford Leeds Research Ethics committee awarded a favourable opinion (18/YH/0396). Results of the study will be published in peer-reviewed journals, and presented at national and international conferences on ageing and dementia.
TRIALS REGISTRATION NUMBER


NCT03656107; Pre-results.",2019,"Participants will be randomised to a 12-week computerised cognitive training programme (five × 30 min sessions per week), or waiting-list control.","[""mild cognitive impairment (MCI) and early Alzheimer's disease (AD"", '60 participants, in three subgroups of 20 (MCI, HC, AD), from primary, secondary and community services', 'healthy older adults (HC), MCI and early AD', 'patients with dementia', 'dementia']","['Cognitive training', 'computerised cognitive training programme', 'brain training', 'semistructured interview to explore barriers and facilitators to cognitive training', 'cognitive training']","['brain blood flow', 'mood, cognition, quality of life and activities of daily living', 'bilateral transcranial Doppler ultrasonography, alongside heart rate (3-lead ECG), end-tidal CO 2  (capnography) and beat-to-beat blood pressure (Finometer', 'Cerebral blood flow']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009482', 'cui_str': 'Services, Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",60.0,0.0999852,"Participants will be randomised to a 12-week computerised cognitive training programme (five × 30 min sessions per week), or waiting-list control.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beishon', 'Affiliation': 'Cardiovascular Sciences, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Evley', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ronney B', 'Initials': 'RB', 'LastName': 'Panerai', 'Affiliation': 'Cardiovascular Sciences, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Subramaniam', 'Affiliation': 'The Evington Centre, Leicestershire Partnership NHSTrust, Leicester, UK.'}, {'ForeName': 'Elizabeta', 'Initials': 'E', 'LastName': 'Mukaetova-Ladinska', 'Affiliation': 'Department of Neuroscience, Psychology and Behaviour, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Cardiovascular Sciences, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Haunton', 'Affiliation': 'Cardiovascular Sciences, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027817']
3164,31139365,Effectiveness of an edutainment video teaching standard precautions - a randomized controlled evaluation study.,"Background


Standard precautions are essential to prevent pathogen transmission and nosocomial infections. We assessed learning effect (primary outcome) and satisfaction (secondary outcome) of watching a 5-min humorous ""edutainment (=education and entertainment) video"" on Standard Precautions compared to reading a written standard operating procedure (SOP) or receiving no intervention.
Methods


This randomized controlled trial was executed at the University Hospital Zurich, Switzerland, a tertiary care centre with a state-of-the-art infection prevention programme. Healthcare providers (HCPs) of different medical departments were 1:1:1 randomized to watching the edutainment video (video group), reading the SOP (SOP group), or no study-specific intervention (no-intervention group). Online questionnaires included a knowledge assessment about Standard Precautions at time point (TP) 1 immediately after intervention, TP2 after 1 month, and TP3 after 3 months. Information about HCPs' satisfaction with the learning method was collected. Variables were assessed within and between groups using the appropriate non-parametric tests. Predictors for knowledge of Standard Precautions were assessed by uni- and multivariable linear regression.
Results


Overall, 363 predominantly female (78.2%) HCPs were included. At TP 1 and TP3, the video group scored better on the knowledge assessment against both the SOP and the no-intervention group (TP1  p  < .001 and 0.001, TP3  p  = 0.036 and 0.048). In the multivariable analysis, being member of the video group was an independent predictor for better knowledge scores. The video was rated higher than the SOP regarding satisfaction with learning experience, and video group participants more frequently indicated they would recommend their learning method to colleagues.
Conclusions


Watching an edutainment video proved to be more effective to improve knowledge about Standard Precautions compared to reading an SOP or no intervention. Satisfaction with the learning method was superior in the video group, suggesting higher potential for future uptake.",2019,Watching an edutainment video proved to be more effective to improve knowledge about Standard Precautions compared to reading an SOP or no intervention.,"['University Hospital Zurich, Switzerland, a tertiary care centre with a state-of-the-art infection prevention programme', 'Healthcare providers (HCPs) of different medical departments', '363 predominantly female (78.2%) HCPs were included']","['watching the edutainment video (video group), reading the SOP (SOP group), or no study-specific intervention (no-intervention group', 'edutainment video teaching standard precautions']","['learning effect (primary outcome) and satisfaction (secondary outcome) of watching a 5-min humorous ""edutainment (=education and entertainment) video"" on Standard Precautions compared to reading a written standard operating procedure (SOP) or receiving no intervention']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0587450', 'cui_str': 'Medical department (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",363.0,0.0811538,Watching an edutainment video proved to be more effective to improve knowledge about Standard Precautions compared to reading an SOP or no intervention.,"[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Wolfensberger', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Clack', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}, {'ForeName': 'Marie-Theres', 'Initials': 'MT', 'LastName': 'Meier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Kuster', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Sax', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Rämistrasse 100, CH-8091 Zurich, Switzerland.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-019-0531-5']
3165,31096775,Rationale and Design of the VITALITY-HFpEF Trial.,"Background The VITALITY-HFpEF trial (Evaluate the Efficacy and Safety of the Oral sGC Stimulator Vericiguat to Improve Physical Functioning in Daily Living Activities of Patients With Heart Failure and Preserved Ejection Fraction) is designed to determine the efficacy and safety of a novel oral soluble guanylate cyclase stimulator, vericiguat, on quality of life and exercise tolerance in heart failure patients with preserved ejection fraction (HFpEF). Impaired physical functioning reduces the quality of life in patients with HFpEF. The primary goal of HF treatment along with improving survival is to improve function, reduce symptoms, and maximize quality of life. Abnormal cyclic guanosine monophosphate signaling may contribute to physical limitations in patients with HFpEF via central and peripheral mechanisms. Exploratory post hoc analyses from a prior trial showed that vericiguat can improve patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire, especially the physical limitation score. Methods and Results VITALITY-HFpEF is a placebo-controlled, double-blind, multi-center, phase IIb trial of ≈735 patients, ≥45 years with HFpEF and ejection fraction ≥45% who will be randomized 1:1:1 to placebo, 10 mg, or 15 mg vericiguat. The primary end point is change in Kansas City Cardiomyopathy Questionnaire physical limitation score from baseline to week 24 and change in 6-minute walk test from baseline to week 24 is the secondary end point. Conclusions VITALITY-HFpEF is the first trial designed to assess the efficacy of vericiguat in patients with HFpEF using the Kansas City Cardiomyopathy Questionnaire physical limitation score as a novel primary end point. This study will also extend the prior dosing experience with vericiguat in HF by studying the safety and efficacy of a 15 mg dose. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT03547583.",2019,"Exploratory post hoc analyses from a prior trial showed that vericiguat can improve patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire, especially the physical limitation score.","['≈735 patients, ≥45 years with HFpEF and ejection fraction ≥45', 'patients with HFpEF', 'Daily Living Activities of Patients With Heart Failure and Preserved Ejection Fraction', 'patients with HFpEF using the Kansas City Cardiomyopathy Questionnaire physical limitation score', 'heart failure patients with preserved ejection fraction (HFpEF', 'patients with HFpEF via central and peripheral mechanisms']","['Oral sGC Stimulator Vericiguat', 'placebo']","['change in Kansas City Cardiomyopathy Questionnaire physical limitation score', 'patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire', 'quality of life', 'function, reduce symptoms, and maximize quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.077282,"Exploratory post hoc analyses from a prior trial showed that vericiguat can improve patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire, especially the physical limitation score.","[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore (C.S.P.L.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.J.A., A.F.H.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (J.E., P.W.A.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.J.A., A.F.H.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke University Medical Center, Durham, NC (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Germany (B.P.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA (S.D.S.).""}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen (A.A.V.), the Netherlands.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.).'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Carvalho', 'Affiliation': 'Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.).'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bamber', 'Affiliation': 'Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.).'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Blaustein', 'Affiliation': 'Cardiovascular Clinical Research, Merck & Co, Inc, Rahway, NJ (R.O.B.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.).'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (J.E., P.W.A.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005998']
3166,30717614,Effects of acute alcohol consumption on emotion recognition in social alcohol drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption alters recognition of emotional expressions. Extending this work, we investigated the effects of alcohol on recognition of six primary expressions of emotion.
METHODS


We conducted two studies using a 2 × 6 experimental design with a between-subjects factor of drink (alcohol, placebo) and a within-subjects factor of emotion (anger, disgust, sadness, surprise, happiness, fear). Study one ( n = 110) was followed by a direct replication study ( n = 192). Participants completed a six alternative forced choice emotion recognition task following consumption of 0.4 g/kg alcohol or placebo. Dependent variables were recognition accuracy (i.e. hits) and false alarms.
RESULTS


There was no clear evidence of differences in recognition accuracy between groups ( ps > .58). In study one, there were more false alarms for anger in the alcohol compared to placebo group ( n = 52 and 56, respectively; t(94.6) = 2.26, p = .024, d = .44) and fewer false alarms for happiness ( t(106) = -2.42, p = .017, d = -.47). However, no clear evidence for these effects was found in study two (alcohol group n = 96, placebo group n = 93, ps > .22). When the data were combined we observed weak evidence of an effect of alcohol on false alarms of anger ( t(295) = 2.25, p = .025, d = .26).
CONCLUSIONS


These studies find weak support for biased anger perception following acute alcohol consumption in social consumers, which could have implications for alcohol-related aggression. Future research should investigate the robustness of this effect, particularly in individuals high in trait aggression.",2019,There was no clear evidence of differences in recognition accuracy between groups ( ps > .58).,"['individuals high in trait aggression', 'social alcohol drinkers']","['six alternative forced choice emotion recognition task following consumption of 0.4\u2009g/kg alcohol or placebo', 'placebo', 'alcohol', 'acute alcohol consumption', 'drink (alcohol, placebo']","['emotion recognition', 'recognition accuracy', 'recognition accuracy (i.e. hits) and false alarms', 'emotion (anger, disgust, sadness, surprise, happiness, fear']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0854086', 'cui_str': 'Social alcohol drinker'}]","[{'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",192.0,0.12139,There was no clear evidence of differences in recognition accuracy between groups ( ps > .58).,"[{'ForeName': 'Jasmine N', 'Initials': 'JN', 'LastName': 'Khouja', 'Affiliation': '1 MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': '1 MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': '2 School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': '1 MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118822169']
3167,31549264,Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer.,"BACKGROUND


There are few third-line or later (3L+) treatment options for advanced/metastatic (adv/met) gastric cancer/gastroesophageal junction cancers (GC/GEJC). 3L+ Nivolumab demonstrated encouraging results in Asian patients in the ATTRACTION-2 study compared with placebo (12-month survival, 26% vs 11%), and in Western patients in the single-arm CheckMate 032 study (12-month survival, 44%). This analysis aimed to establish comparator cohorts of US patients receiving routine care in real-world (RW) clinical practice.
METHODS


A 2-step matching process generated RW cohorts from Flatiron Health's oncology database (January 1, 2011-April 30, 2017), for comparison with each trial: (1) clinical trial eligibility criteria were applied; (2) patients were frequency-matched with trial arms for baseline variables significantly associated with survival. Median overall survival (OS) was calculated by Kaplan-Meier analysis from last treatment until death.
RESULTS


Of 742 adv/met GC/GEJC patients with at least 2 prior lines of therapy, matching generated 90 US RW ATTRACTION-2-matched patients (median OS: 3.5 months) versus 163 ATTRACTION-2 placebo patients (median OS: 4.1 months), and 100 US RW CheckMate 032-matched patients (median OS: 2.9 months) versus 42 CheckMate 032 nivolumab-treated patients (median OS: 8.5 months). Baseline characteristics were generally similar between clinical trial arms and RW-matched cohorts.
CONCLUSIONS


We successfully developed RW cohorts for comparison with data from clinical trials, with comparable baseline characteristics. Survival in US patients receiving RW care was similar to that seen in Asian patients receiving placebo in ATTRACTION-2; survival with nivolumab in CheckMate 032 appeared favorable compared with US RW clinical practice.",2020,Survival in US patients receiving RW care was similar to that seen in Asian patients receiving placebo in ATTRACTION-2; survival with nivolumab in CheckMate 032 appeared favorable compared with US RW clinical practice.,"[""A 2-step matching process generated RW cohorts from Flatiron Health's oncology database (January 1, 2011-April 30, 2017), for comparison with each trial"", 'chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer', 'advanced/metastatic (adv/met) gastric cancer/gastroesophageal junction cancers (GC/GEJC', 'Of 742 adv', 'comparator cohorts of US patients receiving routine care in real-world (RW) clinical practice']","['placebo', '3L']","['Survival', 'Median overall survival (OS', 'survival']","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",742.0,0.314033,Survival in US patients receiving RW care was similar to that seen in Asian patients receiving placebo in ATTRACTION-2; survival with nivolumab in CheckMate 032 appeared favorable compared with US RW clinical practice.,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden Hospital, Surrey, SM2 5PT, UK. Ian.Chau@rmh.nhs.uk.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Ott', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Korytowsky', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'T Kim', 'Initials': 'TK', 'LastName': 'Le', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanchez', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Maglinte', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Laurie', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Abraham', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shangguan', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-019-01008-9']
3168,31200775,Testing the effects of gentle vibrotactile stimulation on symptom relief in fibromyalgia.,"BACKGROUND


Sensory disturbances in fibromyalgia extend beyond nociception. It has been proposed that imbalance in the mutual competition between painful input and non-painful sensory activity may, to a significant extent, account for the augmented subjective perception of pain. In this context, non-nociceptive somatosensory stimulation could arguably attenuate fibromyalgia symptoms by restoring the sensory balance. We specifically tested the effect of vibrotactile stimulation on symptom relief in fibromyalgia patients with a randomized, double-blind, sham-controlled, crossover clinical trial.
METHODS


Seventy-seven female patients were randomized and data from 63 valid cases were analyzed. Active intervention involved extensive body stimulation with gentle mechanical vibrations administered during 3 h at night for 3 weeks, and the placebo effect was controlled using identical instruments to simulate an alternative treatment option. The primary outcome measure combined pain, fatigue, and complaints of poor cognition.
RESULTS


Vibrotactile stimulation was significantly superior to sham in alleviating fibromyalgia symptoms globally. However, univariate analyses showed that the effect was not universal. Benefits were perceived on unpleasant somatic sensations such as generalized pain and fatigue, but not on poor cognition, anxiety, and depression. Vibrotactile stimulation was notably well tolerated and sleep quality significantly improved despite the fact that vibrations were administered at night.
CONCLUSIONS


Results thus provide new evidence that non-nociceptive somatosensory stimulation may favorably act upon altered somatosensory balance in fibromyalgia. From a clinical perspective, both the degree of improvement and the easy application of our proposal would seem to support a potential role for vibrotactile stimulation in the symptomatic treatment of fibromyalgia.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT03227952 . Registered 24 July, 2017.",2019,"Vibrotactile stimulation was notably well tolerated and sleep quality significantly improved despite the fact that vibrations were administered at night.
","['fibromyalgia', 'fibromyalgia patients', 'Seventy-seven female patients']","['gentle vibrotactile stimulation', 'gentle mechanical vibrations', 'vibrotactile stimulation']","['poor cognition, anxiety, and depression', 'symptom relief', 'unpleasant somatic sensations such as generalized pain and fatigue', 'combined pain, fatigue, and complaints of poor cognition', 'fibromyalgia symptoms', 'tolerated and sleep quality']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0234209', 'cui_str': 'Somatic sensation, function'}, {'cui': 'C0281856', 'cui_str': 'Generalized aches and pains (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",77.0,0.362061,"Vibrotactile stimulation was notably well tolerated and sleep quality significantly improved despite the fact that vibrations were administered at night.
","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Pujol', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain. 21404jpn@comb.cat.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramos-López', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blanco-Hinojo', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Pujol', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Ortiz', 'Affiliation': 'Department of Project and Construction Engineering, Universitat Politècnica de Catalunya (UPC), Barcelona, Spain.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Martínez-Vilavella', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Blanch', 'Affiliation': 'Rheumatology Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monfort', 'Affiliation': 'Rheumatology Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Deus', 'Affiliation': 'MRI Research Unit, Department of Radiology, Hospital del Mar, Passeig Marítim 25-29, 08003, Barcelona, Spain.'}]",Arthritis research & therapy,['10.1186/s13075-019-1932-9']
3169,31187344,Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial.,"BACKGROUND


Unhealthy alcohol use has adverse effects on HIV treatment. Screening, brief intervention, and referral to treatment (SBIRT) has some evidence of efficacy but may not be sufficient for those with low motivation or comorbid substance use.
OBJECTIVE


To examine the effectiveness of motivational interviewing (MI) and emailed feedback (EF) among primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT.
DESIGN


Randomized clinical trial.
PARTICIPANTS


Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use.
INTERVENTION


Participants were randomized to either three sessions of MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone. MI and EF participants who reported unhealthy alcohol use at 6 months were offered additional MI and EF treatment, respectively.
MAIN MEASURES


Participant-reported unhealthy alcohol use (defined as ≥ 4/≥ 5 drinks per day for women/men), alcohol problems at 12 months, based on blinded telephone interviews. Secondary outcomes included drug use and antiretroviral (ART) adherence.
KEY RESULTS


At 12 months, there were no overall group differences, but in all three arms, there were declines in unhealthy alcohol use and alcohol-related problems (p < 0.001). Participants reporting low motivation to reduce drinking at baseline were less likely to report unhealthy alcohol use if they received MI vs. EF and UC (p = 0.013). At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012). There were no differences in ART adherence between groups.
CONCLUSIONS


In a randomized trial of HIV-positive patients using two behavioral interventions compared with SBIRT alone, participants in all three conditions reduced unhealthy alcohol use. MI may provide added benefit for patients with low motivation or who report illegal drug use/misuse of prescription drugs.
TRIAL REGISTRATION


NCT01671501 ( ClinicalTrials.gov ).",2019,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","['Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use', 'HIV-positive patients using two', 'primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT', 'patients with low motivation or who report illegal drug use/misuse of prescription drugs', 'Primary Care Patients with HIV']","['MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone', 'motivational interviewing (MI) and emailed feedback (EF', 'behavioral interventions', 'SBIRT alone']","['illegal drug use/misuse of prescription drugs', 'ART adherence', 'unhealthy alcohol use and alcohol-related problems', 'drug use and antiretroviral (ART) adherence']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]",614.0,0.193652,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, 2450 48th Street, Suite 2600, Sacramento, CA, 95817, USA.'}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Kaiser Permanente San Francisco Medical Center, 2238 Geary Blvd, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Lam', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Weisner', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 East Jefferson, Rockville, MD, 20852, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'AIDS Research Institute, University of California, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05065-9']
3170,30724455,"Lorcaserin treatment decreases body weight and reduces cardiometabolic risk factors in obese adults: A six-month, randomized, placebo-controlled, double-blind clinical trial.","Lorcaserin is a serotonin 2c receptor agonist that promotes weight loss while contributing to the prevention and improvement of type 2 diabetes and improvement of atherogenic lipid profiles, without higher rates of major cardiovascular events. The full spectrum of possible lorcaserin-induced improvements in cardiometabolic health remains to be clarified. Thus, we investigated the way in which lorcaserin treatment may alter cardiovascular disease risk, either independently or through changes in body weight. We measured, for the first time, lipid particle quantification, lipid peroxidation, appetite-regulating hormones and mRNA expression of the 5-hydroxytryptamine 2c receptor (5-HT2c receptor). A total of 48 obese participants were enrolled in this six-month, randomized (1:1), placebo-controlled, double-blinded clinical trial. Lorcaserin treatment reduced fat mass (P < 0.001), the fatty liver index (P < 0.0001) and energy intake (P < 0.03) without affecting energy expenditure or lean mass. Total low-density lipoprotein (LDL) (P < 0.04) and small LDL particles (P < 0.03) decreased, while total high-density lipoprotein (HDL) P < 0.02) increased and heart rate significantly decreased with lorcaserin treatment. No mRNA expression of the 5-HT2c receptor was observed in peripheral organs. These data suggest that lorcaserin treatment for six months improves cardiometabolic health in obese individuals, acting mainly through the brain.",2019,"Lorcaserin treatment reduced fat mass (P < 0.001), the fatty liver index (P < 0.0001) and energy intake (P < 0.03) without affecting energy expenditure or lean mass.","['obese adults', '48 obese participants']","['lorcaserin', 'Lorcaserin', 'placebo']","['cardiovascular disease risk', 'cardiometabolic risk factors', 'weight loss', 'fatty liver index', 'heart rate', 'cardiometabolic health', 'small LDL particles', 'Total low-density lipoprotein (LDL', 'fat mass', 'total high-density lipoprotein (HDL', 'lipid particle quantification, lipid peroxidation, appetite-regulating hormones and mRNA expression of the 5-hydroxytryptamine 2c receptor (5-HT2c receptor', 'mRNA expression of the 5-HT2c receptor', 'energy intake', 'body weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0528200', 'cui_str': 'Receptor, Serotonin, 5-HT2C'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",48.0,0.415624,"Lorcaserin treatment reduced fat mass (P < 0.001), the fatty liver index (P < 0.0001) and energy intake (P < 0.03) without affecting energy expenditure or lean mass.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Tuccinardi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jagriti', 'Initials': 'J', 'LastName': 'Upadhyay', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Oussaada', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mathew', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Koniaris', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kelesidis', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, UCLA David Geffen School of Medicine, Los Angels, California.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13655']
3171,30879470,Goal-oriented cognitive rehabilitation for early-stage Alzheimer's and related dementias: the GREAT RCT.,"BACKGROUND


Cognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning.
OBJECTIVES


To determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers.
DESIGN


This multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation.
SETTING


Community.
PARTICIPANTS


Participants had an  International Classification of Diseases , Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm.
INTERVENTION


Cognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants' homes. The therapists were nine occupational therapists and one nurse.
OUTCOME MEASURES


The primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants' group allocation.
RESULTS


A total of 475 participants were randomised (CR arm,  n  = 239; TAU arm,  n  = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,  n  = 208, TAU arm,  n  = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen's d  = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen's d  = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen's  d  = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen's  d  = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost-utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
LIMITATIONS


Possible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia.
CONCLUSIONS


Cognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions.
FUTURE WORK


Next steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN21027481.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.",2019,"There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
","[""people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers"", 'exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English', ""Participants had an  International Classification of Diseases , Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥\u200918 points), were stable on medication if prescribed, and had a family carer who was willing to contribute"", '475 participants were randomised (CR arm,  n \u2009=\u2009239; TAU arm,  n \u2009=\u2009236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,  n \u2009=\u2009208, TAU arm,  n \u2009=\u2009218', 'Community', '350 people to complete the trial, with 175 people in each trial arm', ""early-stage Alzheimer's and related dementias""]","['Goal-oriented cognitive rehabilitation', 'TAU or CR', 'CR', 'Cognitive rehabilitation (CR', 'Cognitive rehabilitation', 'Cognitive rehabilitation consisted of 10 therapy sessions']","['DEMentia Quality Of Life questionnaire utility score', 'participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life', 'cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale', 'carer ratings', 'self-reported goal attainment', 'cost-effectiveness']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3532942', 'cui_str': 'Dementia with mixed etiology'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",475.0,0.233814,"There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kudlicka', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jan R', 'Initials': 'JR', 'LastName': 'Oyebode', 'Affiliation': 'School of Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Jones', 'Affiliation': 'Research Institute for the Care of Older People (RICE), Bath, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, University Hospital Llandough, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Iracema', 'Initials': 'I', 'LastName': 'Leroi', 'Affiliation': 'Department of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kopelman', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, St Thomas' Hospital, King's College London, London, UK.""}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'James', 'Affiliation': 'Centre of the Health of the Elderly, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Culverwell', 'Affiliation': ""Kent and Medway NHS and Social Care Partnership Trust, St Martin's Hospital, Canterbury, UK.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Pool', 'Affiliation': 'Dementia Pal Ltd, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Corbett', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Whitaker', 'Affiliation': 'Whitaker Research Ltd, Bangor, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woods', 'Affiliation': 'Dementia Services Development Centre, Bangor University, Bangor, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23100']
3172,31793890,"Comparison of YouthCHAT, an Electronic Composite Psychosocial Screener, With a Clinician Interview Assessment for Young People: Randomized Controlled Trial.","BACKGROUND


Psychosocial problems such as depression, anxiety, and substance abuse are common and burdensome in young people. In New Zealand, screening for such problems is undertaken routinely only with year 9 students in low-decile schools and opportunistically in pediatric settings using a nonvalidated and time-consuming clinician-administered Home, Education, Eating, Activities, Drugs and Alcohol, Sexuality, Suicide and Depression, Safety (HEEADSSS) interview. The Youth version, Case-finding and Help Assessment Tool (YouthCHAT) is a relatively new, locally developed, electronic tablet-based composite screener for identifying similar psychosocial issues to HEEADSSS.
OBJECTIVE


This study aimed to compare the performance and acceptability of YouthCHAT with face-to-face HEEADSSS assessment among 13-year-old high school students.
METHODS


A counterbalanced randomized trial of YouthCHAT screening either before or after face-to-face HEEADSSS assessment was undertaken with 129 13-year-old New Zealand high school students of predominantly Māori and Pacific Island ethnicity. Main outcome measures were comparability of YouthCHAT and HEEADSSS completion times, detection rates, and acceptability to students and school nurses.
RESULTS


YouthCHAT screening was more than twice as fast as HEEADSSS assessment (mean 8.57 min vs mean 17.22 min; mean difference 8 min 25 seconds [range 6 min 20 seconds to 11 min 10 seconds]; P<.01) and detected more issues overall on comparable domains. For substance misuse and problems at home, both instruments were roughly comparable. YouthCHAT detected significantly more problems with eating or body image perception (70/110, 63.6% vs 25/110, 22.7%; P<.01), sexual health (24/110, 21.8% vs 10/110, 9.1%; P=.01), safety (65/110, 59.1% vs 17/110, 15.5%; P<.01), and physical inactivity (43/110, 39.1% vs 21/110, 19.1%; P<.01). HEEADSSS had a greater rate of detection for a broader set of mental health issues (30/110, 27%) than YouthCHAT (11/110, 10%; P=.001), which only assessed clinically relevant anxiety and depression. Assessment order made no significant difference to the duration of assessment or to the rates of YouthCHAT-detected positive screens for anxiety and depression. There were no significant differences in student acceptability survey results between the two assessments. Nurses identified that students found YouthCHAT easy to answer and that it helped students answer face-to-face questions, especially those of a sensitive nature. Difficulties encountered with YouthCHAT included occasional Wi-Fi connectivity and student literacy issues.
CONCLUSIONS


This study provides preliminary evidence regarding the shorter administration time, detection rates, and acceptability of YouthCHAT as a school-based psychosocial screener for young people. Although further research is needed to confirm its effectiveness in other age and ethnic groups, YouthCHAT shows promise for aiding earlier identification and treatment of common psychosocial problems in young people, including possible use as part of an annual, school-based, holistic health check.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Network Registry (ACTRN) ACTRN12616001243404p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371422.",2019,Assessment order made no significant difference to the duration of assessment or to the rates of YouthCHAT-detected positive screens for anxiety and depression.,"['129 13-year-old New Zealand high school students of predominantly Māori and Pacific Island ethnicity', 'Young People', '13-year-old high school students', 'young people']","['YouthCHAT', 'YouthCHAT screening either before or after face-to-face HEEADSSS assessment']","['safety', 'rate of detection for a broader set of mental health issues', 'problems with eating or body image perception', 'sexual health', 'student acceptability survey', 'physical inactivity', 'shorter administration time, detection rates, and acceptability of YouthCHAT', 'comparability of YouthCHAT and HEEADSSS completion times, detection rates, and acceptability to students and school nurses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030168', 'cui_str': 'Pacific Islands'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0302833', 'cui_str': 'School nurse (occupation)'}]",,0.0858498,Assessment order made no significant difference to the duration of assessment or to the rates of YouthCHAT-detected positive screens for anxiety and depression.,"[{'ForeName': 'Hiran', 'Initials': 'H', 'LastName': 'Thabrew', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': ""D'Silva"", 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Darragh', 'Affiliation': 'Department of General Practice, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Goldfinch', 'Affiliation': 'Tamaki College, Auckland, New Zealand.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Meads', 'Affiliation': 'School of Health Science, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Goodyear-Smith', 'Affiliation': 'Department of General Practice, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/13911']
3173,31722952,Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.,"OBJECTIVE


To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.
DESIGN AND SETTING


A two-arm feasibility RCT conducted across seven general practices in Wessex, UK.
PARTICIPANTS


Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.
INTERVENTIONS


'My Breathing Matters' (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms.
OUTCOMES


The primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control.
RESULTS


Primary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures.
CONCLUSIONS


This study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention.
TRIAL REGISTRATION NUMBER


ISRCTN15698435.",2019,"36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8).","['Primary outcomes: 88 patients were recruited (target 80', 'UK primary care patients with asthma', 'A two-arm feasibility RCT conducted across seven general practices in Wessex, UK', 'Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet']","[""digital self-management intervention 'My Breathing Matters"", 'asthma self-management digital intervention', 'MBM', ""My Breathing Matters' (MBM""]","['feasibility of the trial design, including recruitment, adherence and retention', 'feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control', 'asthma-specific quality of life']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",88.0,0.102788,"36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK b.ainsworth@bath.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Greenwell', 'Affiliation': 'Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Mair', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bruton', 'Affiliation': 'School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032465']
3174,31537373,Co-trimoxazole or multivitamin multimineral supplement for post-discharge outcomes after severe anaemia in African children: a randomised controlled trial.,"BACKGROUND


Severe anaemia is a leading cause of paediatric admission to hospital in Africa; post-discharge outcomes remain poor, with high 6-month mortality (8%) and re-admission (17%). We aimed to investigate post-discharge interventions that might improve outcomes.
METHODS


Within the two-stratum, open-label, multicentre, factorial randomised TRACT trial, children aged 2 months to 12 years with severe anaemia, defined as haemoglobin of less than 6 g/dL, at admission to hospital (three in Uganda, one in Malawi) were randomly assigned, using sequentially numbered envelopes linked to a second non-sequentially numbered set of allocations stratified by centre and severity, to enhanced nutritional supplementation with iron and folate-containing multivitamin multimineral supplements versus iron and folate alone at treatment doses (usual care), and to co-trimoxazole versus no co-trimoxazole. All interventions were administered orally and were given for 3 months after discharge from hospital. Separately reported randomisations investigated transfusion management. The primary outcome was 180-day mortality. All analyses were done in the intention-to-treat population; follow-up was 180 days. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN84086586, and follow-up is complete.
FINDINGS


From Sept 17, 2014, to May 15, 2017, 3983 eligible children were randomly assigned to treatment, and followed up for 180 days. 164 (4%) were lost to follow-up. 1901 (95%) of 1997 assigned multivitamin multimineral supplement, 1911 (96%) of 1986 assigned iron and folate, and 1922 (96%) of 1994 assigned co-trimoxazole started treatment. By day 180, 166 (8%) children in the multivitamin multimineral supplement group versus 169 (9%) children in the iron and folate group had died (hazard ratio [HR] 0·97, 95% CI 0·79-1·21; p=0·81) and 172 (9%) who received co-trimoxazole versus 163 (8%) who did not receive co-trimoxazole had died (HR 1·07, 95% CI 0·86-1·32; p=0·56). We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2). By day 180, 489 (24%) children in the multivitamin multimineral supplement group versus 509 (26%) children in the iron and folate group (HR 0·95, 95% CI 0·84-1·07; p=0·40), and 500 (25%) children in the co-trimoxazole group versus 498 (25%) children in the no co-trimoxazole group (1·01, 0·89-1·15; p=0·85) had had one or more serious adverse events. Most serious adverse events were re-admissions, occurring in 692 (17%) children (175 [4%] with at least two re-admissions).
INTERPRETATION


Neither enhanced supplementation with multivitamin multimineral supplement versus iron and folate treatment or co-trimoxazole prophylaxis improved 6-month survival. High rates of hospital re-admission suggest that novel interventions are urgently required for severe anaemia, given the burden it places on overstretched health services in Africa.
FUNDING


Medical Research Council and Department for International Development.",2019,We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2).,"['From Sept 17, 2014, to May 15, 2017, 3983 eligible children', 'children aged 2 months to 12 years with severe anaemia, defined as haemoglobin of less than 6 g/dL, at admission to hospital (three in Uganda, one in Malawi', 'African children']","['co-trimoxazole', 'sequentially numbered envelopes linked to a second non-sequentially numbered set of allocations stratified by centre and severity, to enhanced nutritional supplementation with iron and folate-containing multivitamin multimineral supplements versus iron and folate alone at treatment doses (usual care), and to co-trimoxazole versus no co-trimoxazole', 'trimoxazole started treatment', 'Co-trimoxazole or multivitamin multimineral supplement', 'multivitamin multimineral supplement versus iron and folate treatment or co-trimoxazole prophylaxis']","['6-month survival', 'serious adverse events', '180-day mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3661595', 'cui_str': 'Multivitamin multimineral supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.276348,We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2).,"[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Maitland', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya. Electronic address: k.maitland@imperial.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olupot-Olupot', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kiguli', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chagaluka', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Alaroker', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Ayub', 'Initials': 'A', 'LastName': 'Mpoya', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Nutrition Research Section, Imperial College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Engoru', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Nteziyaremye', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Machpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': ""College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; School of Medicine, Dentistry and Biomedical Science, Queen's University, Belfast, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nakuya', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Namayanja', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Kayaga', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nabawanuka', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Tonny', 'Initials': 'T', 'LastName': 'Sennyondo', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Aromut', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Felistas', 'Initials': 'F', 'LastName': 'Kumwenda', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Cynthia Williams', 'Initials': 'CW', 'LastName': 'Musika', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Thomason', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Bates', 'Affiliation': 'Liverpool School of Tropical Medicine and Hygiene, Liverpool, UK.'}, {'ForeName': 'Michael Boele', 'Initials': 'MB', 'LastName': 'von Hensbroek', 'Affiliation': ""Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Evans', 'Affiliation': 'Department of Paediatrics, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Uyoga', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'Nutrition Research Section, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'George', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30345-6']
3175,31704275,Can mild cognitive impairment be stabilized by showering brain mitochondria with laser photons?,"There is now substantial evidence that cerebral blood flow (CBF) declines with age. From age 20 to 60, CBF is estimated to dip about 16% and continues to drop at a rate of 0.4%/year. This CBF dip will slowly reduce oxygen/glucose delivery to brain thus lowering ATP energy production needed by brain cells to perform normal activities. Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops. To date, no pharmacological or any other treatment has been successful in reversing, stabilizing or delaying MCI. For the first time in medical interventions, a non-pharmacological, non-invasive, well-tolerated, easy to perform, free of significant side effects and cost-effective treatment may achieve what virtually all AD treatments in the past have been unable to accomplish. This intervention uses transcranial infrared brain stimulation (TIBS), a form of photobiomodulation (PBM). PBM is a bioenergetic non-ionizing, therapeutic approach using low level light emission from laser or light emitting diodes. PBM has been used in a number of neurological conditions including Parkinson's disease, depression, traumatic brain injury, and stroke with diverse reported benefits. This brief review examines the impact of reduced energy supply stemming from chronic brain hypoperfusion in the aging brain. In this context, the use of TIBS is planned in a randomized, placebo-controlled study of MCI patients to be done at our University Clinic. This article is part of the special issue entitled 'The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders'.",2020,Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops.,[],"['placebo', 'MCI', 'PBM']",['cerebral blood flow (CBF) declines'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.0273785,Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops.,"[{'ForeName': 'Jack C', 'Initials': 'JC', 'LastName': 'de la Torre', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, TX, 78712, USA; Department of Physiology, University of Valencia, Valencia, 46010, Spain. Electronic address: jcdelatorre23@yahoo.com.'}, {'ForeName': 'Antonio Del', 'Initials': 'AD', 'LastName': 'Olmo', 'Affiliation': 'Neurology Section, Hospital Universitario Dr. Peset, Valencia, 46017, Spain.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Valles', 'Affiliation': 'Department of Physiology, University of Valencia, Valencia, 46010, Spain.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107841']
3176,31622733,Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC.,"INTRODUCTION


In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42-65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53-0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study.
METHODS


Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method.
RESULTS


As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55-0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses.
CONCLUSIONS


Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.",2020,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","['patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT', 'Stage III NSCLC - Update from PACIFIC', 'Patients, stratified by age, sex and smoking history']","['placebo', 'durvalumab 10 mg/kg intravenously every 2 weeks or placebo', 'durvalumab and placebo', 'durvalumab after chemoradiotherapy']","['3-year OS rates', 'died', 'progression-free survival', 'median OS', 'overall survival', '3-year survival rates', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.557291,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: Jhanelle.Gray@moffitt.org.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, Florida.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, Tennessee; Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'University Hospital Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital, Sydney, New South Wales, Australia; University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'University Hospital October 12, CiberOnc, Complutense University of Madrid, Madrid, Spain; National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'AstraZeneca, Alderley Park, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.002']
3177,31779786,Timing of Staged Nonculprit Artery Revascularization in Patients With ST-Segment Elevation Myocardial Infarction: COMPLETE Trial.,"BACKGROUND


The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD).
OBJECTIVES


The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization.
METHODS


Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days.
RESULTS


For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI.
CONCLUSIONS


Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.",2019,CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00).,"['Patients', 'patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD', 'Infarction', 'Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD', 'STEMI patients with multivessel disease']","['staged nonculprit lesion percutaneous coronary intervention (PCI', 'nonculprit-lesion PCI', 'staged nonculprit-lesion PCI or culprit-lesion only PCI', 'Staged Nonculprit Artery\xa0Revascularization']","['hazard ratios (HRs', 'major cardiovascular (CV) events', 'composite of CV death or myocardial infarction (MI', 'CV death or MI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",4041.0,0.109789,CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00).,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wood', 'Affiliation': ""Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: david.wood@vch.ca.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': ""Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Meeks', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Hahn-Ho', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': ""St Mary's General Hospital, Kitchener, Ontario, Canada.""}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Cheema', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Deghani', 'Affiliation': 'Prairie Vascular Research Network, University of Saskatchewan, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': 'Kardinia House, Geelong, Victoria, Australia.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala Clinical Research Centre and Department of Medical Sciences, Uppsala, Sweden.'}, {'ForeName': 'Ota', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': 'University Hospital St Anne, Brno, Czech Republic.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Niemela', 'Affiliation': 'Heart Centre, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'AlHabib', 'Affiliation': 'Department of Cardiac Services, King Fahad Cardiac Center, Saudi Arabia.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Division of Cardiology, Centre Hospitalier, Universitaire de Sherbrooke, Quebec, Quebec, Canada.'}, {'ForeName': 'Jaydeep', 'Initials': 'J', 'LastName': 'Sarma', 'Affiliation': 'North West Heart Centre, Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Della Siega', 'Affiliation': 'Department of Cardiac Services, Victoria Heart Institute Foundation, Victoria, British Columbia, Canada.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: smehta@mcmaster.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.051']
3178,31588904,The Effect of Robot Attentional Behaviors on User Perceptions and Behaviors in a Simulated Health Care Interaction: Randomized Controlled Trial.,"BACKGROUND


For robots to be effectively used in health applications, they need to display appropriate social behaviors. A fundamental requirement in all social interactions is the ability to engage, maintain, and demonstrate attention. Attentional behaviors include leaning forward, self-disclosure, and changes in voice pitch.
OBJECTIVE


This study aimed to examine the effect of robot attentional behaviors on user perceptions and behaviors in a simulated health care interaction.
METHODS


A parallel randomized controlled trial with a 1:1:1:1 allocation ratio was conducted. We randomized participants to 1 of 4 experimental conditions before engaging in a scripted face-to-face interaction with a fully automated medical receptionist robot. Experimental conditions included a self-disclosure condition, voice pitch change condition, forward lean condition, and neutral condition. Participants completed paper-based postinteraction measures relating to engagement, perceived robot attention, and perceived robot empathy. We video recorded interactions and coded for participant attentional behaviors.
RESULTS


A total of 181 participants were recruited from the University of Auckland. Participants who interacted with the robot in the forward lean and self-disclosure conditions found the robot to be significantly more stimulating than those who interacted with the robot in the voice pitch or neutral conditions (P=.03). Participants in the forward lean, self-disclosure, and neutral conditions found the robot to be significantly more interesting than those in the voice pitch condition (P<.001). Participants in the forward lean and self-disclosure conditions spent significantly more time looking at the robot than participants in the neutral condition (P<.001). Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001).
CONCLUSIONS


The use of self-disclosure and forward lean by a health care robot can increase human engagement and attentional behaviors. Voice pitch changes did not increase attention or engagement. The small effects with regard to participant perceptions are potentially because of the limitations in self-report measures or a lack of comparison for most participants who had never interacted with a robot before. Further research could explore the use of self-disclosure and forward lean using a within-subjects design and in real health care settings.",2019,"Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001).
","['User Perceptions and Behaviors in a Simulated Health Care Interaction', 'A total of 181 participants were recruited from the University of Auckland', 'participants who had never interacted with a robot before']","['4 experimental conditions before engaging in a scripted face-to-face interaction with a fully automated medical receptionist robot', 'robot attentional behaviors', 'Robot Attentional Behaviors']","['self-disclosure condition, voice pitch change condition, forward lean condition, and neutral condition', 'Attentional behaviors include leaning forward, self-disclosure, and changes in voice pitch', 'time looking', 'Voice pitch changes']","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0025099', 'cui_str': 'Medical Receptionists'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0518179', 'cui_str': 'Change in voice (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",181.0,0.0497982,"Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001).
","[{'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Johanson', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'MacDonald', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Byeong Kyu', 'Initials': 'BK', 'LastName': 'Ahn', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'JongYoon', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Euijun', 'Initials': 'E', 'LastName': 'Hwang', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Sutherland', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/13667']
3179,31805968,"Does increased implementation support improve community clinics' guideline-concordant care? Results of a mixed methods, pragmatic comparative effectiveness trial.","BACKGROUND


Disseminating care guidelines into clinical practice remains challenging, partly due to inadequate evidence on how best to help clinics incorporate new guidelines into routine care. This is particularly true in safety net community health centers (CHCs).
METHODS


This pragmatic comparative effectiveness trial used a parallel mixed methods design. Twenty-nine CHC clinics were randomized to receive increasingly intensive implementation support (implementation toolkit (arm 1); toolkit + in-person training + training webinars (arm 2); toolkit + training + webinars + offered practice facilitation (arm 3)) targeting uptake of electronic health record (EHR) tools focused on guideline-concordant cardioprotective prescribing for patients with diabetes. Outcomes were compared across study arms, to test whether increased support yielded additive improvements, and with 137 non-study CHCs that share the same EHR as the study clinics. Quantitative data from the CHCs' EHR were used to compare the magnitude of change in guideline-concordant ACE/ARB and statin prescribing, using adjusted Poisson regressions. Qualitative data collected using diverse methods (e.g., interviews, observations) identified factors influencing the quantitative outcomes.
RESULTS


Outcomes at CHCs receiving higher-intensity support did not improve in an additive pattern. ACE/ARB prescribing did not improve in any CHC group. Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs. Factors influencing the finding of no additive impact included: aspects of the EHR tools that reduced their utility, barriers to providing the intended implementation support, and study design elements, e.g., inability to adapt the provided support. Factors influencing overall improvements in statin outcomes likely included a secular trend in awareness of statin prescribing guidelines, selection bias where motivated clinics volunteered for the study, and study participation focusing clinic staff on the targeted outcomes.
CONCLUSIONS


Efforts to implement care guidelines should: ensure adaptability when providing implementation support and conduct formative evaluations to determine the optimal form of such support for a given clinic; consider how study data collection influences adoption; and consider barriers to clinics' ability to use/accept implementation support as planned. More research is needed on supporting change implementation in under-resourced settings like CHCs.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02325531. Registered 15 December 2014.",2019,Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs.,"['Twenty-nine CHC clinics', 'patients with diabetes']",['intensive implementation support (implementation toolkit (arm 1); toolkit + in-person training + training webinars (arm 2); toolkit + training + webinars + offered practice facilitation (arm 3)) targeting uptake of electronic health record (EHR) tools focused on guideline-concordant cardioprotective prescribing'],[],"[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",[],29.0,0.0904769,Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800\u2009N Interstate Ave, Portland, OR, 97227, USA. rachel.gold@kpchr.org.'}, {'ForeName': 'Arwen', 'Initials': 'A', 'LastName': 'Bunce', 'Affiliation': 'OCHIN, Inc., 1881 NW Naito Pkwy, Portland, OR, 97201, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cowburn', 'Affiliation': 'OCHIN, Inc., 1881 NW Naito Pkwy, Portland, OR, 97201, USA.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Davis', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800\u2009N Interstate Ave, Portland, OR, 97227, USA.'}, {'ForeName': 'Joan C', 'Initials': 'JC', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, Inc., 1881 NW Naito Pkwy, Portland, OR, 97201, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, Inc., 1881 NW Naito Pkwy, Portland, OR, 97201, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hicks', 'Affiliation': 'Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horberg', 'Affiliation': 'Kaiser Permanente Mid-Atlantic Permanente Research Institute, 2101 East Jefferson St, Rockville, MD, 20852, USA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Melgar', 'Affiliation': 'Cowlitz Family Health Center, 1057 12th Avenue, Longview, WA, 98632, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Dearing', 'Affiliation': 'Michigan State University, 404 Wilson Rd, Room 473, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seabrook', 'Affiliation': 'Community HealthNet Health Centers, 1021 West 5th Avenue, Gary, IN, 46402, USA.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Mossman', 'Affiliation': 'OCHIN, Inc., 1881 NW Naito Pkwy, Portland, OR, 97201, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Bulkley', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800\u2009N Interstate Ave, Portland, OR, 97227, USA.'}]",Implementation science : IS,['10.1186/s13012-019-0948-5']
3180,31228054,Impact of Social Needs Navigation on Utilization Among High Utilizers in a Large Integrated Health System: a Quasi-experimental Study.,"BACKGROUND


Programs addressing social determinants of health for high-utilizing patients are gaining interest among health systems as an avenue to promote health and decrease utilization.
OBJECTIVE


To evaluate impacts of a social needs screening and navigation program for adult predicted high utilizers on total medical visit utilization.
DESIGN


A prospective, quasi-experimental study using an intent-to-treat propensity-weighted difference-in-differences approach. Stratified analyses assessed intervention effects among three low-socioeconomic status sub-samples: patients in low-income areas, in low-education areas, and with Medicaid insurance.
PARTICIPANTS


Predicted high utilizers-patients predicted to be in the highest 1% for total utilization in a large integrated health system.
INTERVENTION


A telephonic social needs screening and navigation program.
MAIN MEASURES


Primary difference-in-difference analyses compared total visit count utilization, including outpatient, emergency department (ED), and inpatient utilization, between the intervention and control groups at both in-network and out-of-network facilities. Prevalence of social needs among sample patients and their connection rates to social needs resources are also described.
KEY RESULTS


The study included 34,225 patients (7107 intervention, 27,118 control). Most (53%) patients screened reported social needs, but only a minority (10%) of those with a need were able to connect with resources to address these needs. Primary analysis found total utilization visits decreased 2.2% (95% CI - 4.5%, 0.1%; p = 0.058) in the intervention group. Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
CONCLUSIONS


Social needs navigation programs for high-utilizing patients may have modest effects on utilization for the population overall. However, significant decreases in utilization were found among low-socioeconomic status patients more likely to experience social needs.",2019,"Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
","['Predicted high utilizers-patients predicted to be in the highest 1% for total utilization in a large integrated health system', 'three low-socioeconomic status sub-samples: patients in low-income areas, in low-education areas, and with Medicaid insurance', '34,225 patients (7107 intervention, 27,118 control']","['social needs screening and navigation program', 'Social Needs Navigation']","['Utilization', 'utilization', 'total visit count utilization, including outpatient, emergency department (ED), and inpatient utilization', 'total utilization visits', 'total utilization']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]",34225.0,0.0268934,"Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Schickedanz', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine at UCLA, 10960 Wilshire Blvd., Suite 960, Los Angeles, CA, 90024, USA. Aschickedanz@mednet.ucla.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Yi R', 'Initials': 'YR', 'LastName': 'Hu', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Nirav R', 'Initials': 'NR', 'LastName': 'Shah', 'Affiliation': 'Stanford University Clinical Excellence Research Center, Stanford, CA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Adams', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Francis', 'Affiliation': 'Health Leads, Boston, MA, USA.'}, {'ForeName': 'Artair', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Health Leads, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05123-2']
3181,31135821,Association Between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada.,"Importance


Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes.
Objective


To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time.
Design, Setting, and Participants


This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019.
Main Outcomes and Measures


The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication.
Results


The final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication.
Conclusions and Relevance


The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.",2019,"No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication.
","['The final cohort comprised 28\u202f468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years', 'patients included in the study (n\u2009=\u200928\u202f468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation', 'Participants\n\n\nThis interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system', 'Patients from the province of Quebec', 'randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2']",[],"['survival or clinical outcomes', 'proportion of early dialysis starts', 'monthly proportion of early dialysis starts', 'acute inpatient dialysis initiations']","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0260039', 'cui_str': 'Nephrologists'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C3850092', 'cui_str': 'Interrupted Time Series'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C3811844'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",[],"[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",28468.0,0.167033,"No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication.
","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Ferguson', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Manish M', 'Initials': 'MM', 'LastName': 'Sood', 'Affiliation': 'The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rigatto', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chau', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Komenda', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Naimark', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gihad E', 'Initials': 'GE', 'LastName': 'Nesrallah', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Soroka', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Beaulieu', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'S Joseph', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': ""O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0489']
3182,31013182,Randomized Phase II Trial to Compare the Efficacy of Haloperidol and Olanzapine in the Control of Chemotherapy-Induced Nausea and Vomiting in Nepal.,"PURPOSE


The purpose of the study was to compare efficacy and toxicity of olanzapine (OLN; a higher-cost drug) and haloperidol (HAL; a lower-cost drug) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who receive highly emetogenic chemotherapy (HEC).
PATIENTS AND METHODS


In a randomized, phase II trial, patients were randomly assigned to receive either OLN 10 mg orally on days 1 to 4 or HAL 1 mg orally on day 1 and 0.5 mg twice daily on days 2 to 4. Both groups received ondansetron 16 mg and dexamethasone 12 mg intravenously on day 1. Patients recorded their nausea using the Edmonton Symptom Assessment Scale (ESAS) and recorded daily episodes of vomiting from day 1 to day 5. The primary end point was complete nausea prevention (CNP; ie, ESAS of 0). Secondary end point was complete emesis prevention (CEP).
RESULTS


Sixty-five patients were randomly assigned, and 64 received their allocated treatment (n = 32 in each arm). There was no difference in CNP during the overall period (days 1 to 5) between OLN and HAL (68.7%  v  71.8%;  P  = .78). In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3%  v  81.2%; delayed: 68.7%  v  75%). No difference was identified in the rate of CEP during the overall period (81.2% with OLN  v  78.1% with HAL;  P  = .75), during the acute period (93.7% with OLN  v  90.6% with HAL), or during the delayed period (84.3% with OLN  v  84.3% with HAL). No difference in toxicities was noted between treatment arms.
CONCLUSION


In this study, HAL had comparable efficacy to OLN in the management of CINV, which suggests that it is the higher-value option in patients who receive HEC in resource-scarce countries.",2019,"In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3%  v  81.2%; delayed: 68.7%  v  75%).","['Sixty-five patients', 'patients who receive HEC in resource-scarce countries', 'Nepal', 'patients who receive highly emetogenic chemotherapy (HEC']","['OLN 10 mg orally on days 1 to 4 or HAL', 'olanzapine (OLN', 'HAL', 'Haloperidol and Olanzapine', 'ondansetron 16 mg and dexamethasone', 'OLN', 'haloperidol (HAL']","['complete nausea prevention (CNP; ie, ESAS of 0', 'Nausea and Vomiting', 'nausea and vomiting (CINV', 'nausea using the Edmonton Symptom Assessment Scale (ESAS) and recorded daily episodes of vomiting', 'CNP', 'efficacy and toxicity', 'toxicities', 'complete emesis prevention (CEP', 'rate of CEP']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1134857', 'cui_str': 'Ondansetron 16 MG'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",65.0,0.0485401,"In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3%  v  81.2%; delayed: 68.7%  v  75%).","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Dulal', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bishnu Dutta', 'Initials': 'BD', 'LastName': 'Paudel', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Aarati', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bibek', 'Initials': 'B', 'LastName': 'Acharya', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bishesh Sharma', 'Initials': 'BS', 'LastName': 'Poudyal', 'Affiliation': 'Civil Service Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Ramila', 'Initials': 'R', 'LastName': 'Shilpakar', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Lori Anne', 'Initials': 'LA', 'LastName': 'Wood', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}]",Journal of global oncology,['10.1200/JGO.18.00245']
3183,30761976,The CORE service improvement programme for mental health crisis resolution teams: results from a cluster-randomised trial.,"BACKGROUND


Crisis resolution teams (CRTs) offer brief, intensive home treatment for people experiencing mental health crisis. CRT implementation is highly variable; positive trial outcomes have not been reproduced in scaled-up CRT care.
AIMS


To evaluate a 1-year programme to improve CRTs' model fidelity in a non-masked, cluster-randomised trial (part of the Crisis team Optimisation and RElapse prevention (CORE) research programme, trial registration number: ISRCTN47185233).
METHOD


Fifteen CRTs in England received an intervention, informed by the US Implementing Evidence-Based Practice project, involving support from a CRT facilitator, online implementation resources and regular team fidelity reviews. Ten control CRTs received no additional support. The primary outcome was patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8), completed by 15 patients per team at CRT discharge (n = 375). Secondary outcomes: CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions were also evaluated.
RESULTS


All CRTs were retained in the trial. Median follow-up CSQ-8 score was 28 in each group: the adjusted average in the intervention group was higher than in the control group by 0.97 (95% CI -1.02 to 2.97) but this was not significant (P = 0.34). There were fewer in-patient admissions, lower in-patient bed use and better staff psychological health in intervention teams. Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up. There were no significant effects for other outcomes.
CONCLUSIONS


The CRT service improvement programme did not achieve its primary aim of improving patient satisfaction. It showed some promise in improving CRT model fidelity and reducing acute in-patient admissions.",2020,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,['people experiencing mental health crisis'],[],"['CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions', 'Model fidelity', 'patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8', 'Median follow-up CSQ-8 score', 'CRT model fidelity', 'patient satisfaction', 'patient admissions, lower in-patient bed use and better staff psychological health']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}]",[],"[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",375.0,0.271692,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Senior Lecturer, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Professor of Psychiatric Epidemiology, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Principal Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Associate Professor in Medical Statistics, Department of Statistical Science, UCL, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Senior Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Mason', 'Affiliation': 'Reader in Clinical Psychology, School of Psychology, University of Surrey, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Research Fellow, Epidemiology and Health Services Research, CLAHRC West, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Clinical Senior Lecturer, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Onyett', 'Affiliation': 'previously Chief Executive, Onyett Entero, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Principal Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Associate Professor, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'Professor of Nursing, School of Health and Human Sciences, University of Essex, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Consultant Psychiatrist, Barnes Unit, John Radcliffe Hospital, Oxford Health NHS Foundation Trust, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Christoforou', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fullarton', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forsyth', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Piotrowski', 'Affiliation': 'Research Assistant, Avon and Wiltshire Mental Health Partnership NHS Trust, Research & Development Office, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mundy', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bond', 'Affiliation': 'Professor of Psychiatry, Westat, Rivermill Commercial Center, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Professor of Social and Community Psychiatry, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.21']
3184,30959472,Efficacy of Oral Cryotherapy During Oxaliplatin Infusion in Preventing Oral Thermal Hyperalgesia: A Randomized Trial.,"BACKGROUND


Chemotherapy-induced oral thermal hyperalgesia (OTH) is a common and debilitating side effect of platinum-based anticancer agents. This study evaluated the efficacy of oral cryotherapy in preventing OTH during oxaliplatin chemotherapy infusion.
METHODS


Patients with gastrointestinal cancer treated with biweekly oxaliplatin (85 mg/m2 over 120 minutes) at Abramson Cancer Center at the University of Pennsylvania were randomized to receive oral cryotherapy (ice chips) during oxaliplatin infusion or standard-of-care treatment. All patients completed baseline questionnaires regarding oral and peripheral symptoms and on-treatment questionnaires on day 1 of each subsequent chemotherapy cycle. Those in the treatment arm were asked to document how long they kept the ice chips in their mouths (0, <30, 30, 60, 90, or 120 minutes) and to report their discomfort associated with oral cryotherapy. Evaluable patients were those who had completed at least 2 cycles of oxaliplatin therapy.
RESULTS


Of 62 randomized patients with a variety of gastrointestinal malignancies, 50 (25 per treatment arm) were evaluable for efficacy. The rate of patients with oral symptoms after the first treatment cycle was significantly lower in the intervention arm (n=8; 32%) than in the control arm (n=18; 72%), meeting the primary study objective (P=.01). The magnitude of difference in symptom scores before versus after the first treatment cycle was significantly less in the intervention versus control arm (P=.001). No difference in oral symptoms over time was seen between the intervention and control groups (P=.20), although a high attrition rate was noted. Duration of ice chip exposure was associated with improved oral symptoms over time (P=.02).
CONCLUSIONS


Oral cryotherapy is a tolerable and cost-effective method of diminishing OTH in patients receiving oxaliplatin chemotherapy, and seems to be most effective in the early stages of treatment.",2019,The magnitude of difference in symptom scores before versus after the first treatment cycle was significantly less in the intervention versus control arm (P=.001).,"['Evaluable patients were those who had completed at least 2 cycles of oxaliplatin therapy', '62 randomized patients with a variety of gastrointestinal malignancies, 50 (25 per treatment arm) were evaluable for efficacy', '85 mg/m2 over 120 minutes) at Abramson Cancer Center at the University of Pennsylvania', 'Patients with gastrointestinal cancer treated with biweekly']","['oxaliplatin chemotherapy', 'Chemotherapy-induced oral thermal hyperalgesia (OTH', 'Oxaliplatin Infusion', 'Oral Cryotherapy', 'oral cryotherapy', 'oxaliplatin', 'Oral cryotherapy', 'oral cryotherapy (ice chips) during oxaliplatin infusion or standard-of-care treatment']","['attrition rate', 'symptom scores', 'rate of patients with oral symptoms', 'oral symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0751214', 'cui_str': 'Hyperalgesia, Thermal'}, {'cui': 'C0449210', 'cui_str': 'OTH (body structure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",62.0,0.0295305,The magnitude of difference in symptom scores before versus after the first treatment cycle was significantly less in the intervention versus control arm (P=.001).,"[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bauman', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Mick', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Lawless', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Zinck', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Sinclair', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fuhrer', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Hara"", 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Dwyer"", 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Plastaras', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Teitelbaum', 'Affiliation': 'Abramson Cancer Center.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7110']
3185,31096780,Feasibility and preliminary efficacy of a parent-mediated sexual education curriculum for youth with autism spectrum disorders.,"Youth with autism spectrum disorder can face social-communication challenges related to sexuality, dating, and friendships. The purpose of this study was to assess the feasibility, acceptability, and preliminary efficacy of the Supporting Teens with Autism on Relationships program. In total, 84 youth with autism spectrum disorder aged 9 to 18 and their parents participated in this study; two groups received the Supporting Teens with Autism on Relationships program (interventionist-led parent group vs parent self-guided), while an attentional control group received a substance abuse prevention program that included instruction in problem-solving and social skills. Feasibility and acceptability of the Supporting Teens with Autism on Relationships program was high overall. The Supporting Teens with Autism on Relationships program was effective in increasing parent and youth knowledge of sexuality, while the attentional control was not. There was preliminary support for improvement in parenting efficacy related to discussing sexuality with their children. Gains were seen among completers regardless of whether the parent received support from a facilitator. Implications and future directions are discussed.",2020,There was preliminary support for improvement in parenting efficacy related to discussing sexuality with their children.,"['Youth with autism spectrum disorder', 'Teens with Autism on Relationships program', 'youth with autism spectrum disorders', '84 youth with autism spectrum disorder aged 9 to 18 and their parents participated in this study; two groups received the Supporting Teens with Autism on']","['Relationships program (interventionist-led parent group vs parent self-guided), while an attentional control group received a substance abuse prevention program that included instruction in problem-solving and social skills', 'parent-mediated sexual education curriculum']","['Feasibility and acceptability', 'feasibility, acceptability', 'parenting efficacy']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1171221', 'cui_str': 'Substance abuse prevention'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",84.0,0.0143254,There was preliminary support for improvement in parenting efficacy related to discussing sexuality with their children.,"[{'ForeName': 'Cara E', 'Initials': 'CE', 'LastName': 'Pugliese', 'Affiliation': ""Children's National Health System, USA.""}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Ratto', 'Affiliation': ""Children's National Health System, USA.""}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Granader', 'Affiliation': ""Children's National Health System, USA.""}, {'ForeName': 'Katerina M', 'Initials': 'KM', 'LastName': 'Dudley', 'Affiliation': ""Children's National Health System, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Danya International, Inc., USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Danya International, Inc., USA.'}, {'ForeName': 'Laura Gutermuth', 'Initials': 'LG', 'LastName': 'Anthony', 'Affiliation': ""Children's National Health System, USA.""}]",Autism : the international journal of research and practice,['10.1177/1362361319842978']
3186,30847828,Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.,"BACKGROUND


Pre-treatment factors that increase smokers' risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown.
OBJECTIVE


To identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES.
DESIGN


A prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial.
PARTICIPANTS


Smokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders.
INTERVENTIONS


Bupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up.
MAIN MEASURES


Primary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.
KEY RESULTS


The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study.
CONCLUSIONS


Irrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01456936.",2019,The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%).,"['N\u2009=\u20094050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N\u2009=\u20092882; 71%), anxiety (N\u2009=\u2009782; 19%), and psychotic (N\u2009=\u2009386; 10%) disorders', 'smokers with psychiatric disorders', 'Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study', 'Smokers without (N\u2009=\u20093984; NPC)/with']","['Bupropion, 150\xa0mg twice daily, or varenicline, 1\xa0mg twice daily, versus active control (nicotine patch, 21\xa0mg/day with taper) and placebo']","['HADS anxiety score', 'incidence of a composite measure of moderate/severe NPSAEs', 'incidence of moderate to severe NPSAEs', 'suicidal ideation and/or behavior', 'current anxiety or prior suicidal ideation', 'absolute risk of occurrence of the NPSAE endpoint']","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0931029,The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%).,"[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA. ranthenelli@ucsd.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaffney', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'University College, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'St Aubin', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Krishen', 'Affiliation': 'PAREXEL International on behalf of GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04858-2']
3187,30711665,"Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT) Trial: Rationale, design, and baseline characteristics.","Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance. Participants (N = 230, Mean age = 72) were randomly assigned to one of four training conditions: broad training using either (1) a web-based brain game suite, Brain HQ, or (2) a strategy video game, Rise of Nations, or to directed training for (3) Instrumental Activities of Daily Living (IADL) training using web-based programs for both driving and fraud avoidance training, or (4) to an active control condition of puzzle solving. Training took approximately 15-20 h for each intervention condition across four weeks. Before training began, participants received baseline ability tests of perception, attention, memory, cognition, and IADL, including a driving simulator test for hazard perception, and a financial fraud recognition test. They were tested again on these measures following training completion (post-test). A one-year follow-up from training completion is also scheduled. The baseline results support that randomization was successful across the intervention conditions. We discuss challenges and potential solutions for using technology-based interventions with older adults. We also discuss how the current trial addressed methodological limitations of previous intervention studies. TRIAL REGISTRATION NUMBER: NCT03141281.",2019,Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence.,"['Participants (N\u202f=\u202f230, Mean age\u202f=\u202f72', 'older adults']","['Adult Cognitive Training (ICE-ACT', 'broad and directed (narrow) technology-based training', 'baseline ability tests of perception, attention, memory, cognition, and IADL, including a driving simulator test for hazard perception, and a financial fraud recognition test', 'broad training using either (1) a web-based brain game suite, Brain HQ, or (2) a strategy video game, Rise of Nations, or to directed training for (3) Instrumental Activities of Daily Living (IADL) training using web-based programs for both driving and fraud avoidance training, or (4) to an active control condition of puzzle solving']",['cognitive abilities'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0016684', 'cui_str': 'Fraud'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0423995', 'cui_str': 'Puzzled (finding)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",72.0,0.0579709,Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence.,"[{'ForeName': 'Jong-Sung', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States. Electronic address: yoon@psy.fsu.edu.'}, {'ForeName': 'Nelson A', 'Initials': 'NA', 'LastName': 'Roque', 'Affiliation': 'Penn State University, Center for Healthy Aging, University Park, PA, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Andringa', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Harrell', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}, {'ForeName': 'Katharine G', 'Initials': 'KG', 'LastName': 'Lewis', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vitale', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Charness', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Boot', 'Affiliation': 'Florida State University, Department of Psychology, Tallahassee, FL, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.014']
3188,30610677,"Response to Letter to the Editor Re: ""EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial"".",,2019,,['Super-Obese Patients'],['Botulinum Toxin A'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}]",[],,0.0355796,,"[{'ForeName': 'Igor Braga', 'Initials': 'IB', 'LastName': 'Ribeiro', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Hospital das Clínicas, School of Medicine, University of Sao Paulo, São Paulo, Brazil. igorbraga1@gmail.com.'}, {'ForeName': 'Diogo Turiani Hourneaux', 'Initials': 'DTH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Hospital das Clínicas, School of Medicine, University of Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Hospital das Clínicas, School of Medicine, University of Sao Paulo, São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-018-03665-8']
3189,31087200,Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer.,"BACKGROUND


Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients.
METHODS


In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed.
RESULTS


Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab-. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3-12.9] vs 3.1 [1.9-5.3] months, hazard ratio, 0.38 [0.22-0.66]; P = 0.0006; Tmab-, 4.8 [4.1-6.0] vs 4.2 [3.6-4.9] months, 0.71 [0.57-0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001).
CONCLUSIONS


Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer.",2020,"PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001).
","['patients with advanced G/GEJ cancer', 'patients with advanced gastric/gastroesophageal junction cancer', 'patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction ', '493 enrolled patients, 81 (nivolumab, n\u2009=\u200959; placebo, n\u2009=\u200922) were Tmab+ and 412 (nivolumab, n\u2009=\u2009271; placebo, n\u2009=\u2009141) were Tmab', 'patients with prior']","['trastuzumab use (Tmab', 'placebo', 'nivolumab', 'trastuzumab', 'nivolumab vs placebo']","['longer median OS', 'Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety', 'PFS', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",493.0,0.68002,"PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001).
","[{'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Cheol Chung', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Song-Dang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Ki Kang', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kun-Huei', 'Initials': 'KH', 'LastName': 'Yeh', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Sang Cheul', 'Initials': 'SC', 'LastName': 'Oh', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Bai', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Keio Cancer Center, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jong Gwang', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Minashi', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Medical Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Mitsunobu', 'Initials': 'M', 'LastName': 'Tanimoto', 'Affiliation': 'Oncology Clinical Development Planning, Oncology Clinical Development Unit, ONO Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Li-Tzong', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, and National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. nboku@ncc.go.jp.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-019-00970-8']
3190,30561835,Normothermic Machine Perfusion (NMP) Inhibits Proinflammatory Responses in the Liver and Promotes Regeneration.,"Liver transplantation (LT) is a successful treatment for patients with liver failure. However, organ shortage results in over 11% of patients losing their chance of a transplant attributed to liver decompensation (LD) and death. Ischemia/reperfusion injury (IRI) following conventional cold storage (CS) is a major cause of injury leading to graft loss after LT. Normothermic machine perfusion (NMP), a method of organ preservation, provides oxygen and nutrition during preservation and allows aerobic metabolism. NMP has recently been shown to enable improved organ utilization and posttransplant outcomes following a phase I and a phase III randomized trial. The aim of the present study is to assess the impact of NMP on reducing IRI and to define the underlying mechanisms. We transplanted and compared 12 NMP with 27 CS-preserved livers by performing gene microarray, immunoprofiling of hepatic lymphocytes, and immunochemistry staining of liver tissues for assessing necrosis, platelet deposition, and neutrophil infiltration, and the status of steatosis after NMP or CS prereperfusion and postreperfusion. Recipients receiving NMP grafts showed significantly lower peak aspartate aminotransferase (AST) levels than those receiving CS grafts. NMP altered gene-expression profiles of liver tissue from proinflammation to prohealing and regeneration. NMP also reduced the number of interferon gamma (IFN-γ) and interleukin (IL)-17-producing T cells and enlarged the CD4 pos  CD25 high  CD127 neg  FOXP3 pos  regulatory T cell (Treg) pool. NMP liver tissues showed less necrosis and apoptosis in the parenchyma and fewer neutrophil infiltration compared to CS liver tissues. Conclusion: Reduced IRI in NMP recipients was the consequence of the combination of inhibiting inflammation and promoting graft regeneration.",2019,NMP also reduced the number of interferon gamma (IFN-γ) and interleukin (IL)-17-producing T cells and enlarged the CD4 pos  CD25 high  CD127 neg  FOXP3 pos  regulatory T cell (Treg) pool.,['patients with liver failure'],"['NMP grafts', 'NMP', 'Liver transplantation (LT', 'Normothermic Machine Perfusion (NMP', 'conventional cold storage (CS', 'Normothermic machine perfusion (NMP']","['peak aspartate aminotransferase (AST) levels', 'liver decompensation (LD) and death', 'Ischemia/reperfusion injury (IRI', 'number of interferon gamma (IFN-γ) and interleukin (IL)-17-producing T cells and enlarged the CD4 pos  CD25 high  CD127 neg  FOXP3 pos  regulatory T cell (Treg) pool']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}]",,0.0640165,NMP also reduced the number of interferon gamma (IFN-γ) and interleukin (IL)-17-producing T cells and enlarged the CD4 pos  CD25 high  CD127 neg  FOXP3 pos  regulatory T cell (Treg) pool.,"[{'ForeName': 'Wayel', 'Initials': 'W', 'LastName': 'Jassem', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Xystrakis', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Yasmeen G', 'Initials': 'YG', 'LastName': 'Ghnewa', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Yuksel', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Oltin', 'Initials': 'O', 'LastName': 'Pop', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Martinez-Llordella', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Yamen', 'Initials': 'Y', 'LastName': 'Jabri', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Lozano', 'Affiliation': 'Bioinformatics Platform, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Quaglia', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sanchez-Fueyo', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Constantin C', 'Initials': 'CC', 'LastName': 'Coussios', 'Affiliation': 'Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rela', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Friend', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Heaton', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Institute of Liver Studies, Department of Inflammation Biology, School of Immunology and Microbial Science, King's College London, London, United Kingdom.""}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30475']
3191,32145005,Relations between gait characteristics and subjective visual vertical results in young adults.,"OBJECTIVE


Subjective visual vertical (SVV) deviation can indicate impairments of motion perception and spatial orientation in individuals with vestibular disorders. This study investigated the influence of SVV on tandem gait ability by assessing differences between temporal, spatial, and kinematic characteristics in young adults.
METHODS


We recruited sixteen young adults with increased SVV and 17 age-matched control subjects. All subjects recruited for this study were with no history of neurological or musculoskeletal diseases. Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability were measured during tandem gait.
RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05). In addition, a significant correlation was observed between stride time variability and SVV results (r = 0.345, p < 0.05). However, hip and knee joint angles were non-significantly different in the experimental and control groups (p > 0.05) and spatio-temporal parameters were similar between the two groups (p > 0.05).
CONCLUSION


Stride time variability and stride velocity variability during tandem gait were significantly different in the experimental and control groups. We presume that increased SVV deviation is related to greater gait variability during tandem gait.",2020,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","['young adults', 'All subjects recruited for this study were with no history of neurological or musculoskeletal diseases', 'sixteen young adults with increased SVV and 17 age-matched control subjects', 'individuals with vestibular disorders']","['SVV', 'Subjective visual vertical (SVV) deviation']","['Stride time variability and stride velocity variability', 'Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability', 'hip and knee joint angles', 'SVV deviation', 'stride time variability and SVV results', 'Stride time variability and stride velocity variability during tandem gait']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231779', 'cui_str': 'Heel toe gait (finding)'}]",16.0,0.019152,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","[{'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Science, Graduate School of Health and Welfare, Dankook University, Republic of Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}, {'ForeName': 'Sang Seok', 'Initials': 'SS', 'LastName': 'Yeo', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-200694']
3192,30576716,Effect of all-extremity high-intensity interval training vs. moderate-intensity continuous training on aerobic fitness in middle-aged and older adults with type 2 diabetes: A randomized controlled trial.,"Aging and diabetes are associated with decreased aerobic fitness, an independent predictor of mortality. Aerobic exercise is prescribed to improve aerobic fitness; however, middle-aged/older diabetic patients often suffer from mobility limitations which restrict walking. Non-weight-bearing/low-impact exercise is recommended but the optimal exercise prescription is uncertain. The goal of this randomized controlled trial was twofold: 1) to test if high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), implemented on a non-weight-bearing all-extremity ergometer, are feasible, well-tolerated and safe in middle-aged/older adults with type 2 diabetes; and 2) to test whether all-extremity HIIT is more effective in improving aerobic fitness than MICT. A total of 58 sedentary individuals with type 2 diabetes (46 to 78 years; 63 ± 1) were randomized to all-extremity HIIT (n = 23), MICT (n = 19) or non-exercise control (CONT; n = 16). All-extremity HIIT and MICT, performed 4×/week for 8 weeks under supervision, resulted in no adverse events requiring hospitalization or medical treatment. Aerobic fitness (VO 2peak ) improved by 10% in HIIT and 8% in MICT and maximal exercise tolerance increased by 1.8 and 1.3 min, respectively (P ≤ 0.002 vs. baseline; P ≥ 0.9 for HIIT vs. MICT). In conclusion, all-extremity HIIT and MICT are feasible, well-tolerated and safe and result in similar improvements in aerobic fitness in middle-aged/older individuals with type 2 diabetes. These findings have important implications for exercise prescription for diabetic patients; they indicate that all-extremity exercise is a feasible alternative to weight-bearing exercise and those who are unable or unwilling to engage in HIIT may receive similar benefits from MICT.",2019,"Aerobic fitness (VO 2peak ) improved by 10% in HIIT and 8% in MICT and maximal exercise tolerance increased by 1.8 and 1.3 min, respectively (P ≤ 0.002 vs. baseline; P ≥ 0.9 for HIIT vs. MICT).","['middle-aged and older adults with type 2 diabetes', '58 sedentary individuals with type 2 diabetes (46 to 78\u202fyears; 63\u202f±\u202f1', 'middle-aged/older diabetic patients', 'middle-aged/older adults with type 2 diabetes', 'middle-aged/older individuals with type 2 diabetes', 'diabetic patients']","['high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), implemented on a non-weight-bearing all-extremity ergometer', 'Aerobic exercise', 'MICT (n\u202f=\u202f19) or non-exercise control (CONT', 'extremity high-intensity interval training vs. moderate-intensity continuous training']","['aerobic fitness', 'Aerobic fitness (VO 2peak ', 'maximal exercise tolerance']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026062', 'cui_str': 'Middle Age'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0278454', 'cui_str': 'All extremities (body structure)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",58.0,0.0409805,"Aerobic fitness (VO 2peak ) improved by 10% in HIIT and 8% in MICT and maximal exercise tolerance increased by 1.8 and 1.3 min, respectively (P ≤ 0.002 vs. baseline; P ≥ 0.9 for HIIT vs. MICT).","[{'ForeName': 'Chueh-Lung', 'Initials': 'CL', 'LastName': 'Hwang', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Jisok', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Jeung-Ki', 'Initials': 'JK', 'LastName': 'Yoo', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Han-Kyul', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Moon-Hyon', 'Initials': 'MH', 'LastName': 'Hwang', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America; Division of Health and Exercise Science, Incheon National University, Incheon, Republic of Korea.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Handberg', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Petersen', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Brady J', 'Initials': 'BJ', 'LastName': 'Holmer', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Leey Casella', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Demetra D', 'Initials': 'DD', 'LastName': 'Christou', 'Affiliation': 'Department of Applied Physiology & Kinesiology, University of Florida, Gainesville, FL, United States of America. Electronic address: ddchristou@ufl.edu.'}]",Experimental gerontology,['10.1016/j.exger.2018.12.013']
3193,29670285,A randomized trial of normothermic preservation in liver transplantation.,"Liver transplantation is a highly successful treatment, but is severely limited by the shortage in donor organs. However, many potential donor organs cannot be used; this is because sub-optimal livers do not tolerate conventional cold storage and there is no reliable way to assess organ viability preoperatively. Normothermic machine perfusion maintains the liver in a physiological state, avoids cooling and allows recovery and functional testing. Here we show that, in a randomized trial with 220 liver transplantations, compared to conventional static cold storage, normothermic preservation is associated with a 50% lower level of graft injury, measured by hepatocellular enzyme release, despite a 50% lower rate of organ discard and a 54% longer mean preservation time. There was no significant difference in bile duct complications, graft survival or survival of the patient. If translated to clinical practice, these results would have a major impact on liver transplant outcomes and waiting list mortality.",2018,"There was no significant difference in bile duct complications, graft survival or survival of the patient.",['liver transplantation'],['Normothermic machine perfusion'],"['bile duct complications, graft survival or survival']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0005400', 'cui_str': 'Bile Ducts'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",220.0,0.0988723,"There was no significant difference in bile duct complications, graft survival or survival of the patient.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nasralla', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. david.nasralla@nds.ox.ac.uk.'}, {'ForeName': 'Constantin C', 'Initials': 'CC', 'LastName': 'Coussios', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK. constantin.coussios@eng.ox.ac.uk.'}, {'ForeName': 'Hynek', 'Initials': 'H', 'LastName': 'Mergental', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'M Zeeshan', 'Initials': 'MZ', 'LastName': 'Akhtar', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Butler', 'Affiliation': ""University of Cambridge Department of Surgery, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Carlo D L', 'Initials': 'CDL', 'LastName': 'Ceresa', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'García-Valdecasas', 'Affiliation': 'Department of Hepatobiliopancreatic and Transplant Surgery, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Heaton', 'Affiliation': ""Institute of Liver Studies, King's College Hospital, London, UK.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Imber', 'Affiliation': 'Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Wayel', 'Initials': 'W', 'LastName': 'Jassem', 'Affiliation': ""Institute of Liver Studies, King's College Hospital, London, UK.""}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Jochmans', 'Affiliation': 'Abdominal Transplant Surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Karani', 'Affiliation': ""Institute of Liver Studies, King's College Hospital, London, UK.""}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Knight', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peri', 'Initials': 'P', 'LastName': 'Kocabayoglu', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Malagò', 'Affiliation': 'Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Mirza', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Morris', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Pallan', 'Affiliation': 'Department of Radiology, Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Department of Hepatobiliopancreatic and Transplant Surgery, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'M Thamara P R', 'Initials': 'MTPR', 'LastName': 'Perera', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Pirenne', 'Affiliation': 'Abdominal Transplant Surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Ravikumar', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'OrganOx Limited, Oxford, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Upponi', 'Affiliation': ""Department of Radiology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Chris J E', 'Initials': 'CJE', 'LastName': 'Watson', 'Affiliation': ""University of Cambridge Department of Surgery, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weissenbacher', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rutger J', 'Initials': 'RJ', 'LastName': 'Ploeg', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Friend', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. peter.friend@nds.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature,['10.1038/s41586-018-0047-9']
3194,30252113,The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial.,"OBJECTIVE


Women with chronic urogenital pain (CUP) conditions have elevated rates of lifetime trauma, relational stress, and emotional conflicts, but directly assessing and treating psychological stress is rarely done in women's health care settings. We developed and tested the effects on patients' somatic and psychological symptoms of a life stress interview that encourages disclosure about stressors and uses experiential techniques to increase awareness of links between stress, emotions, and symptoms.
METHODS


In this randomized trial, women with CUP recruited at a multidisciplinary women's urology center received either a single 90-minute life stress interview (N = 37) or no interview (treatment-as-usual control; N = 25). Self-report measures of pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression) were completed at baseline and six-week follow-up.
RESULTS


Differences between the life stress interview and control conditions at follow-up were tested with analyses of covariance, controlling for baseline level of the outcome and baseline depression. Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
CONCLUSIONS


An intensive life stress emotional awareness expression interview improved physical but not psychological symptoms among women with CUP seen in a tertiary care clinic. This study suggests that targeting stress and avoided emotions and linking them to symptoms may be beneficial for this complex group of patients.",2019,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
","['Objective\n\n\nWomen with chronic urogenital pain (CUP', ""women with CUP recruited at a multidisciplinary women's urology center received either a"", 'Women with Chronic Urogenital Pain', 'women with CUP seen in a tertiary care clinic']","['Life Stress Emotional Awareness and Expression Interview', 'single 90-minute life stress interview (N\u2009=\u200937) or no interview (treatment-as-usual control; N\u2009=\u200925']","['pain severity and pelvic floor symptoms', 'pain interference or psychological symptoms', 'pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression', 'awareness of links between stress, emotions, and symptoms']","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.101268,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Carty', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tomakowsky', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Health / Providence-Providence Park Hospital, Michigan State University College of Human Medicine, Southfield, Michigan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny182']
3195,30202946,The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.,"BACKGROUND


The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results.
METHODS


Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment.
RESULTS


Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782.
CONCLUSION


Recruitment for ω-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.",2019,The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.,"['1,087 participants had slow gait speed (<1 m/s', '289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the', 'Methods\n\n\nEligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment', 'older adults with mobility impairment', 'Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized', 'Seniors (ENRGISE', 'A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening']","['omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan', 'losartan']",['walking speed'],"[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",289.0,0.173642,The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.,"[{'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lovato', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Talton', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Stowe', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walkup', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly204']
3196,29236547,The Impact of Smokeless Tobacco Risk Information on Smokers' Risk Perceptions and Use Intentions: A News Media Experiment.,"Little research exists on the impact of risk information comparing smokeless tobacco (SLT) use, particularly snus, to cigarette smoking. This study explored this topic using a communication channel where smokers may be exposed to such information-the news media. We randomly assigned 1008 current smokers to read one of three constructed news stories or to a control group (no article). The ""favorable"" story framed snus as a ""safer"" smoking alternative while the ""cautious"" story described snus risks. The ""mixed"" version described potential risks and harm-reduction benefits. Participants completed a post-article survey with snus risk and harm perception and use intention measures. Article condition was significantly associated with perceived harm of daily snus use relative to smoking (1 = a lot less harmful - 5 = a lot more harmful; p < .0001), and mean ratings of snus harm in the favorable (2.46) and mixed conditions (2.66) were significantly lower than those of the cautious (2.96) and control conditions (2.98). Mean interest in trying snus in the next 6 months was low, but significantly higher for those in the favorable (1.55) and mixed conditions (1.32) versus those in the cautious (1.17) and control conditions (1.16)(1 = not at all - 5 = extremely interested, p < .0001). There were no significant differences by group in terms of the story's perceived interestingness, importance, or relevance. Exposure to reduced-risk news messages about SLT and snus relative to cigarettes may impact smokers' SLT harm perceptions and use intentions. Tobacco control professionals and FDA officials should consider the potential impact of the news media when communicating about tobacco risks.",2019,"Article condition was significantly associated with perceived harm of daily snus use relative to smoking (1 = a lot less harmful - 5 = a lot more harmful; p < .0001), and mean ratings of snus harm in the favorable (2.46) and mixed conditions (2.66) were significantly lower than those of the cautious (2.96) and control conditions (2.98).","[""Smokers' Risk Perceptions and Use Intentions""]","['Smokeless Tobacco Risk Information', 'smokeless tobacco (SLT']","[""story's perceived interestingness, importance, or relevance"", 'mean ratings of snus harm']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4288198', 'cui_str': 'Snus'}]",1008.0,0.0171258,"Article condition was significantly associated with perceived harm of daily snus use relative to smoking (1 = a lot less harmful - 5 = a lot more harmful; p < .0001), and mean ratings of snus harm in the favorable (2.46) and mixed conditions (2.66) were significantly lower than those of the cautious (2.96) and control conditions (2.98).","[{'ForeName': 'Olivia A', 'Initials': 'OA', 'LastName': 'Wackowski', 'Affiliation': 'a Department of Social & Behavioral Health Sciences , Center for Tobacco Studies, Rutgers University.'}, {'ForeName': 'Michelle T Bover', 'Initials': 'MTB', 'LastName': 'Manderski', 'Affiliation': 'a Department of Social & Behavioral Health Sciences , Center for Tobacco Studies, Rutgers University.'}, {'ForeName': 'M Jane', 'Initials': 'MJ', 'LastName': 'Lewis', 'Affiliation': 'a Department of Social & Behavioral Health Sciences , Center for Tobacco Studies, Rutgers University.'}, {'ForeName': 'Cristine D', 'Initials': 'CD', 'LastName': 'Delnevo', 'Affiliation': 'a Department of Social & Behavioral Health Sciences , Center for Tobacco Studies, Rutgers University.'}]",Health communication,['10.1080/10410236.2017.1407226']
3197,30865917,"Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life.","BACKGROUND


Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL).
MATERIALS AND METHODS


From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression.
RESULTS


At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= -0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
CONCLUSIONS


Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.",2019,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","['From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center']",['Oral Chemotherapy'],"['Anxiety symptoms', 'Adherence, Symptoms, and Quality of Life', 'mean electronic pill cap adherence rate', 'memory problems', 'emotional distress', 'depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction', 'drowsiness', 'adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment', 'disturbed sleep', 'medication adherence and quality of life (QoL']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037438'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",181.0,0.10383,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Ream', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pensak', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Nisotel', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'University of Colorado at Boulder, Boulder, Colorado.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'MacDonald', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Buzaglo', 'Affiliation': 'Cancer Support Community, Washington, DC.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, Miami, Florida; and.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7098']
3198,30165595,Progressive Resistance Training Improves Torque Capacity and Strength in Mobility-Limited Older Adults.,"BACKGROUND


Progressive resistance training (PRT) is consistently shown to improve muscle strength in older adults. The efficacy of PRT to improve muscle fatigue in older adults with demonstrated mobility limitations remains unclear.
METHODS


Mobility-limited (Short Physical Performance Battery [SPPB] ≤ 9) older adults (age 70-92 years) were recruited for this study and randomized to either PRT or home-based flexibility (FLEX) 3 d/wk for 12 weeks. Muscle fatigue and strength outcomes were assessed at baseline and 12 weeks. The primary outcome was torque capacity, a composite measure of strength and fatigue, defined as the sum of peak torques from an isokinetic fatigue test.
RESULTS


Seventy participants were randomized (mean [SD] age 78.9 [5.4] years; 60% female; mean [SD] SPPB 7.5 [1.6]). At follow-up, the PRT group improved significantly in torque capacity, mean between-group difference (95% confidence interval) 466.19 (138.4, 793.97) Nm (p = .006), and maximal strength 127.3 (60.96, 193.61) Nm (p = .0003), when compared with FLEX group. Neither group demonstrated significant changes in muscle fatigue or torque variability.
CONCLUSION


Twelve weeks of PRT improved torque capacity, as well as strength in mobility-limited older adults. These results demonstrate PRT improves multiple age-related muscular impairments.",2019,"Neither group demonstrated significant changes in muscle fatigue or torque variability.
","['70 subjects were randomized [mean (SD) age 78.9 (5.4) years; 60% female; mean (SD) SPPB 7.5 (1.6', 'Methods\n\n\nMobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (age 70 - 92 yrs', 'mobility-limited older adults', 'older adults']","['Progressive resistance training', 'PRT or home-based flexibility (FLEX', 'PRT', '\n\n\nProgressive resistance training (PRT']","['torque capacity, a composite measure of strength and fatigue, defined as the sum of peak torques from an isokinetic fatigue test', 'torque capacity', 'muscle fatigue', 'muscle fatigue or torque variability', 'Muscle fatigue and strength outcomes', 'torque capacity and strength']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}]",70.0,0.0544578,"Neither group demonstrated significant changes in muscle fatigue or torque variability.
","[{'ForeName': 'Davis A', 'Initials': 'DA', 'LastName': 'Englund', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lori Lyn', 'Initials': 'LL', 'LastName': 'Price', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Astellas Pharma, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': 'Astellas Pharma, Tokyo, Japan.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly199']
3199,31150063,Quantification of the Capacity for Cold-Induced Thermogenesis in Young Men With and Without Obesity.,"OBJECTIVE


Cold exposure increases energy expenditure (EE) and could have a role in combating obesity. To understand this potential, we determined the capacity for cold-induced thermogenesis (CIT), the EE increase above the basal metabolic rate at the individualized coldest tolerable temperature before overt shivering.
DESIGN


During a 13-day inpatient protocol, we quantitated the EE of 12 lean men and 9 men with obesity at various randomly ordered ambient temperatures in a room calorimeter. Subjects underwent brown fat imaging after exposure to their coldest tolerable temperature.
RESULTS


CIT capacity was 300 ± 218 kcal/d (mean ± SD) or 17 ± 11% in lean men and 125 ± 146 kcal/d or 6 ± 7% in men with obesity (P = 0.01). The temperature below which EE increased, lower critical temperature (Tlc), was warmer in lean men than men with obesity (22.9 ± 1.2 vs 21.1 ± 1.7°C, P = 0.03), but both had similar skin temperature (Tskin) changes and coldest tolerable temperatures. Whereas lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the Tlc in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after nonshivering thermogenesis is maximal.
CONCLUSIONS


Despite greater insulation from fat, men with obesity had a narrower range of tolerable cool temperatures available for increasing EE and less capacity for CIT than lean men, likely as a result of greater basal heat production and similar perception to Tskin cooling. Further study of the reduced CIT capacity in men with obesity may inform treatment opportunities for obesity.",2019,"While lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the lower critical temperature in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after non-shivering thermogenesis is maximal.
","['young men with and without obesity', '12 lean men and 9 men with obesity at various randomly ordered ambient temperatures in a room calorimeter', 'men with obesity']",[],"['skin temperature changes and coldest tolerable temperatures', 'CIT capacity', 'temperature below which energy expenditure', 'brown fat activity, skeletal muscle activity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0542496', 'cui_str': 'Ambient temperature (observable entity)'}]",[],"[{'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006298', 'cui_str': 'Brown Fat'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]",12.0,0.0209791,"While lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the lower critical temperature in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after non-shivering thermogenesis is maximal.
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brychta', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brooks P', 'Initials': 'BP', 'LastName': 'Leitner', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jacob D', 'Initials': 'JD', 'LastName': 'Hattenbach', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Bell', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fletcher', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Perron Wood', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Idelson', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Duckworth', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGehee', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Courville', 'Affiliation': 'Nutrition Department, Hatfield Clinical Research Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shanna B', 'Initials': 'SB', 'LastName': 'Bernstein', 'Affiliation': 'Nutrition Department, Hatfield Clinical Research Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Reitman', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Cypess', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00728']
3200,32115311,Aggression Prevention Training for Individuals With Dementia and Their Caregivers: A Randomized Controlled Trial.,"OBJECTIVE


International appeals call for interventions to prevent aggression and other behavioral problems in individuals with dementia (IWD). Aggression Prevention Training (APT), based on intervening in three contributors to development of aggression (IWD pain, IWD depression, and caregiver-IWD relationship problems) aims to reduce incidence of aggression in IWD over 1 year.
DESIGN


Randomized, controlled trial.
SETTING


Three clinics that assess, diagnose, and treat dementia.
PARTICIPANTS


Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC).
INTERVENTION


APT, a skills-based intervention delivered over 3 months to address pain/depression/caregiver-IWD relationship issues. EU-PC included printed material on dementia and community resources; and eight brief, weekly support calls.
MEASUREMENTS


The primary outcome was incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale. Secondary outcomes included pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety.
RESULTS


Aggression incidence and secondary outcomes did not differ between groups. However, in those screening positive for IWD depression or caregiver-IWD relationship problems, those receiving EU-PC had significant increases in depression and significant decreases in quality of the caregiver-IWD relationship, whereas those receiving APT showed no changes in these outcomes over time.
CONCLUSION


The cost to patients, family, and society of behavioral problems in IWD, along with modest efficacy of most pharmacologic and nonpharmacologic interventions, calls for more study of novel preventive approaches.",2020,"RESULTS


Aggression incidence and secondary outcomes did not differ between groups.","['Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC', 'Three clinics that assess, diagnose, and treat dementia', 'individuals with dementia (IWD', 'Individuals With Dementia and Their Caregivers']","['Aggression Prevention Training', 'Aggression Prevention Training (APT']","['incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale', 'IWD pain, IWD depression, and caregiver-IWD relationship problems', 'depression', 'quality of the caregiver-IWD relationship', 'pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",228.0,0.24421,"RESULTS


Aggression incidence and secondary outcomes did not differ between groups.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX. Electronic address: mkunik@bcm.edu.'}, {'ForeName': 'Melinda A', 'Initials': 'MA', 'LastName': 'Stanley', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Srijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Wheaton College (SS), Norton, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ramsey', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Richey', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snow', 'Affiliation': 'Tuscaloosa VA Medical Center (LS), Tuscaloosa, AL; The University of Alabama Center for Mental Health and Aging (LS), Tuscaloosa, AL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Freshour', 'Affiliation': 'Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Evans', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Newmark', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Kelsey Seybold Research Foundation (MN), West University Place, TX.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Amspoker', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.01.190']
3201,31446581,Comparison of the effects of 10.6-μm infrared laser and traditional moxibustion in the treatment of knee osteoarthritis.,"Based on two separate randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion in treating knee osteoarthritis (OA), we did an indirect and preliminary comparison of the effects of the 10.6-μm laser moxibustion with the traditional moxibustion for knee osteoarthritis. The objective was to see whether the laser moxibustion is non-inferior to the traditional moxibustion in alleviating symptoms of knee osteoarthritis such as pain, stiffness, and joint dysfunction as well as improving quality of life for the patients with knee osteoarthritis, and whether a further RCT directly comparing the laser and traditional moxibustion is necessary. Pooled data from two RCTs in patients with knee osteoarthritis, trial ISRCTN68475405 and trial ISRCTN26065334, were used. In the two RCTs, the eligibility criteria were almost identical, the treatment procedure (i.e., sessions, duration, and points) were similar, and the outcome measurements (i.e., WOMAC for symptoms and SF-36 for quality of life) were the same. The double robustness method was used for the WOMAC scale and the SF-36 endpoints to detect the difference between traditional and laser moxibustion. The analysis comprised 55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group). Demographic characteristics and course of disease were similar between the two groups. Causal inference, using the doubly robust estimating approach to correct for bias due to baseline differences, showed that there was no statistically significant difference in the WOMAC pain, stiffness, and physical function between the two treatments at midterm, end of treatment, and 4 weeks after the end of treatment (P > 0.05). The exception was that there was statistically significantly more benefit associated with laser moxibustion compared with traditional moxibustion in physical function at the follow-up of 4 weeks after the end of treatment (P=0.006). There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002). The benefits of 10.6-μm infrared laser moxibustion and the traditional moxibustion for knee osteoarthritis were comparable in pain, stiffness, physical dysfunction, and in most of the quality of life subdimensions. The laser moxibustion might be more beneficial in terms of physical function, body pain, and mental health in the long term. RCTs directly comparing 10.6-μm laser moxibustion with traditional moxibustion are warranted.",2020,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","['knee osteoarthritis (OA', '55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group', 'patients with knee osteoarthritis', 'knee osteoarthritis']","['10.6-μm infrared laser and traditional moxibustion', 'laser moxibustion', '10.6-μm laser moxibustion with the traditional moxibustion', 'traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion', '10.6-μm infrared laser moxibustion']","['most SF-36 endpoints', 'pain, stiffness, physical dysfunction', 'physical function, body pain, and mental health', 'Demographic characteristics and course of disease', 'WOMAC pain, stiffness, and physical function', 'WOMAC scale', 'physical function', 'WOMAC for symptoms and SF-36 for quality of life', 'physical functioning (PF), mental health (MH), and bodily pain (BP']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0449206,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. cheng_ker@hotmail.com.'}, {'ForeName': 'Ming T', 'Initials': 'MT', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Bioinformatics & Biomathematics, Georgetown University Medical Center, Washington, D.C., 20057, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Zouqin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, Shanghai, 201299, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Zhongshan Hospital of Zhejiang Province, Hangzhou, 310005, Zhejiang Province, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Haimeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. sxy1@shutcm.edu.cn.'}]",Lasers in medical science,['10.1007/s10103-019-02863-9']
3202,31226435,Taurine supplementation increases irisin levels after high intensity physical training in obese women.,"BACKGROUND


Irisin is a myokine/adipokine that under stimulus of physical exercise is able to improve thermogenic capacity in adipose tissue. Likewise, taurine supplementation has demonstrated similar effects on energy metabolism. Therefore, we hypothesized that taurine supplementation combined with physical training may induce an increase in irisin concentrations, optimizing energy metabolism in obese individuals.
OBJECTIVE


To evaluate if taurine supplementation associated with a high intensity physical training program increases irisin levels in obese women.
METHODS


double-blind study with 22 obese women (BMI 32.4 ± 2.0 kg/m 2 , 36.6 ± 6.4 years and sedentary) who were randomly divided into two groups, control group (GC, n = 14), exercised and supplemented with placebo (3 g of starch), and taurine group (GTAU, n = 8), exercised and supplemented with taurine (3 g). The subjects performed high intensity physical training, Deep Water Running (DWR), for 8 weeks, 3 times/week, for 50 min per training session, at 70-85% maximum heart rate. Resting metabolic rate (RMR) was evaluated by indirect calorimetry, body composition by deuterium oxide, plasma taurine by HPLC, plasma irisin by Multiplex Kit, and food consumption by food records. The results were analyzed by an ANOVA two way repeated measures mixed model, with the Sidak post hoc (p < 0.05).
RESULTS


No changes were observed in body composition. DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
CONCLUSION


DWR associated with taurine supplementation resulted in increased plasma irisin concentrations after physical training in obese adult women.",2019,"DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
","['22 obese women (BMI 32.4\u202f±\u202f2.0\u202fkg/m 2 , 36.6\u202f±\u202f6.4\u202fyears and sedentary', 'obese individuals', 'obese women', 'obese adult women']","['taurine supplementation combined with physical training', 'Taurine supplementation', 'taurine supplementation', 'intensity physical training program', 'intensity physical training, Deep Water Running (DWR', 'control group (GC, n\u202f=\u202f14), exercised and supplemented with placebo (3\u202fg of starch), and taurine group (GTAU, n\u202f=\u202f8), exercised and supplemented with taurine']","['energy metabolism', 'Resting metabolic rate (RMR', 'plasma irisin concentrations', 'irisin levels', 'body composition', 'body composition by deuterium oxide, plasma taurine by HPLC, plasma irisin by Multiplex Kit, and food consumption', 'irisin concentrations, optimizing energy metabolism']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0454406', 'cui_str': 'Water running (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",22.0,0.111995,"DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil. Electronic address: gabibatitucci@gmail.com.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: camilafbrandao@hotmail.com.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: flaviagiolo@gmail.com.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: jsmarchi@fmrp.usp.br.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Pfrimer', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: karinapfrimer@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferrioli', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: eferriol@fmrp.usp.br.'}, {'ForeName': 'Fernando Queiroz', 'Initials': 'FQ', 'LastName': 'Cunha', 'Affiliation': 'Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: fdqcunha@fmrp.usp.br.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Papoti', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: mpapoti@usp.br.'}, {'ForeName': 'Sara Ivone Barros Morhy', 'Initials': 'SIBM', 'LastName': 'Terrazas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil. Electronic address: saraterrazas@yahoo.com.br.'}, {'ForeName': 'Márcia Varella Morandi', 'Initials': 'MVM', 'LastName': 'Junqueira-Franco', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: mvmjf@hotmail.com.'}, {'ForeName': 'Adelino Sanchez Ramos', 'Initials': 'ASR', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: adelinosanchez@hotmail.com.'}, {'ForeName': 'Ellen Cristini de', 'Initials': 'EC', 'LastName': 'Freitas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil; School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: ellenfreitas@usp.br.'}]",Cytokine,['10.1016/j.cyto.2019.154741']
3203,32073676,"Beta-blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity rationale and study design of a prospective, randomized, controlled trial (The Preserve-HR trial).","BACKGROUND


The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta-blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients.
HYPOTHESIS


We postulate beta-blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short-term effect of beta-blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI.
METHODS


This is a prospective, crossover, randomized (1:1) and multicenter study. After randomization, the clinical and cardiac rhythm will be continuously registered for 30 days. PeakVO2 is assessed by cardiopulmonary exercise testing (CPET) at 15 and 30 days in both groups. Secondary endpoints include quality of life, cognitive, and safety assessment. Patients with stable HFpEF, functional class New York Heart Association (NYHA) II-III, chronic treatment with beta-blockers, and ChI will be enrolled. A sample size estimation [alfa: 0.05, power: 90%, a 20% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD ± 2.0)] of 52 patients is necessary to test our hypothesis.
RESULTS


Patients started enrolling in October 2018. As January 14th, 2020, 28 patients have been enrolled. It is projected to enroll the last patient at the end of July 2020.
CONCLUSIONS


Optimizing therapy that improves functional capacity remains an unmeet priority in HFpEF. Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity. This trial is an attempt towards precision medicine in this complex syndrome.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03871803.",2020,Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity.,"['Patients started enrolling in October 2018', 'patients with heart failure with preserved ejection fraction and chronotropic incompetence', '28 patients have been enrolled', 'Patients with stable HFpEF, functional class New York Heart Association (NYHA) II-III, chronic treatment with beta-blockers, and ChI will be enrolled', 'patients with HFpEF and ChI', 'patients with HFpEF and ChI.\nMETHODS']",[],"['loss rate, and delta change of mean peakVO2', 'quality of life, cognitive, and safety assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1997984', 'cui_str': 'Chronotropic incompetence (finding)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[],"[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.124945,Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palau', 'Affiliation': 'FISABIO. Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Seller', 'Affiliation': 'Cardiology Department, Hospital de Denia, Alicante, Spain.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Domínguez', 'Affiliation': 'FISABIO. Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Gómez', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Ramón', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Sastre', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Espriella', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Santas', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Chorro', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'CIBERCV, Madrid, Spain.'}]",Clinical cardiology,['10.1002/clc.23345']
3204,32068684,MsFLASH network vaginal health trial: absence of evidence is NOT evidence of absence.,"Approximately 50% of postmenopausal women experience vulvovaginal symptoms associated with genitourinary syndrome of menopause (GSM). GSM is a chronic and progressive condition with a well-defined treatment algorithm. Analysis of the MsFLASH Vaginal Health Trial data produced two main conclusions, which were that prescribed vaginal 10 μg estradiol tablet and over-the-counter (OTC) vaginal moisturizer did not provide additional benefit over placebo vaginal tablet and placebo gel in reducing postmenopausal vulvovaginal symptoms; or increasing the proportions of women reporting sexual activity or improving pain scores with sexual activity. These treatment conclusions are contrary to all prior robust clinical trial data for dyspareunia and vaginal dryness, and not in line with the good clinical practice for GSM management presented by the American College of Obstetricians and Gynecologists, The North American Menopause Society, and the Endocrine Society. Overall, the flaws of the MsFLASH Vaginal Health Trial were to incorrectly identify the therapeutic outcomes of most interest using metrics that exhibit high degrees of placebo bias; and to utilize low statistical power with which to appreciate any significant differences between groups.",2020,"These treatment conclusions are contrary to all prior robust clinical trial data for dyspareunia and vaginal dryness, and not in line with the good clinical practice for GSM management presented by the American College of Obstetricians and Gynecologists, The North American Menopause Society, and the Endocrine Society.",['postmenopausal women experience vulvovaginal symptoms associated with genitourinary syndrome of menopause (GSM'],"['GSM', 'placebo vaginal tablet and placebo gel']","['postmenopausal vulvovaginal symptoms', 'pain scores with sexual activity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}]","[{'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042264', 'cui_str': 'Vaginal Tablet'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.256407,"These treatment conclusions are contrary to all prior robust clinical trial data for dyspareunia and vaginal dryness, and not in line with the good clinical practice for GSM management presented by the American College of Obstetricians and Gynecologists, The North American Menopause Society, and the Endocrine Society.","[{'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Lukas', 'Affiliation': 'IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'IntimMedicine Specialists, Washington, DC.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001516']
3205,32098716,Masked comparison of two silicone hydrogel bandage contact lenses after photorefractive keratectomy.,"PURPOSE


To compare the efficiency and safety of two bandage contact lenses after photorefractive keratectomy (PRK).
METHODS


In this double-blind study, 45 patients (90 eyes) received PRK in both eyes and wore bandage contact lenses (BCLs), PureVision (Bausch & Lomb, Rochester, NY, USA) in one eye and PureVision2 (Bausch & Lomb, Rochester, NY, USA) in the other eye, randomly assigned. The medication regimen after surgery was the same for both eyes. The epithelial defect's size, conjunctival hyperemia and lens centration were graded objectively using slit-lamp biomicroscopy on days 1, 3 and 5 after surgery. Also ocular symptoms of discomfort including tearing, photophobia, foreign body sensation and visual fluctuations were assessed subjectively at each visit.
RESULTS


The mean epithelial defect size on the first day after operation was similar in eyes fitted with PureVision (30.08 ± 5.30 mm²) and PureVision2 (30.25 ± 5.72 mm 2 ) lenses. (p = 0.79) Contact lens deposits and bulbar hyperaemia on days 1 and 3 after PRK were similar between the two eyes, but were significantly greater on day 5 for PureVision2 lenses. (p = 0.02; p = 0.04 respectively) There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2. (p > 0.05) CONCLUSIONS: PureVision and PureVision2 contact lenses are equivalent as bandage lenses in important aspects such as corneal re-epithelialization and subjective comfort., although PureVision2 led to a higher incidence of contact lens deposits and conjunctival hyperemia early post-PRK.",2020,"There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2.",['45 patients (90 eyes) received'],"['PureVision and PureVision2 contact lenses', 'PRK in both eyes and wore bandage contact lenses (BCLs), PureVision (Bausch & Lomb, Rochester, NY, USA', 'bandage contact lenses after photorefractive keratectomy (PRK', 'silicone hydrogel bandage contact lenses']","[""epithelial defect's size, conjunctival hyperemia and lens centration"", 'ocular symptoms of discomfort including tearing, photophobia, foreign body sensation and visual fluctuations', 'efficiency and safety', 'mean epithelial defect size', 'contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations', 'Contact lens deposits and bulbar hyperaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0395416', 'cui_str': 'Photorefractive Keratectomy'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C1449669', 'cui_str': 'Bandages, Hydrogel'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}]",45.0,0.067977,"There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2.","[{'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Bagherian', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Zarei-Ghanavati', 'Affiliation': 'Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Momeni-Moghaddam', 'Affiliation': 'Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran; Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: hmomeni_opt@zaums.ac.ir.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sedaghat', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shehzad A', 'Initials': 'SA', 'LastName': 'Naroo', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Naeemeh', 'Initials': 'N', 'LastName': 'Monfared', 'Affiliation': 'Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.005']
3206,30118625,A Novel Infant Chest Compression Assist Device Using a Palm Rather Than Fingers: A Randomized Crossover Trial.,"Objective:  We developed a novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR). We hypothesized that the palm presser will increase compression depth without increasing hands-off time and will reduce rescuer fatigue compared with the two-finger technique (TFT). Methods:  In this randomized crossover manikin trial, participants performed two minutes of CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT in randomized sequence on an infant manikin. CPR parameters, including compression depth and hands-off time, were collected to compare CPR quality between the palm presser and the TFT. The linear mixed-effect model was used to control the carryover effect of a crossover design in the analysis of CPR parameters. To evaluate rescuer fatigue, we compared changes in compression depth over time and calculated the odds of sufficiently deep compressions over time between the two groups. Results:  The palm presser resulted in greater mean compression depth (41.5 ± 1.6 mm vs. 36.8 ± 5.5 mm, p < 0.001), greater sufficiently deep compressions (80.9 ± 27.8% vs. 42.4 ± 35.4%, p < 0.001), and better correct hand position (99.9 ± 0.5% vs. 83.9 ± 25.3%, p = 0.013) than the TFT. Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time were not significantly different between the two groups. The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024 [95% CI -0.030 to -0.018] vs. -0.004 [95% CI -0.006 to -0.002]). The odds of a compression depth greater than 40 mm increased 2.8 times (95% CI 2.2 to 3.4) with the TFT during the first minute compared with the last minute, whereas the corresponding odds ratio when using the palm presser was not significantly different in the first and last minutes (OR: 1.2 [95% CI 0.9 to 1.5]). Conclusions:  Compression with palm pressers resulted in greater compression depth without increasing hands-off time and reduced rescuer fatigue compared with compression with the TFT in simulated infant CPR with manikins.",2019,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,['Than Fingers'],"['CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT', 'novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR', 'TFT']","['odds of a compression depth', 'rescuer fatigue', 'mean change in compression depth over time', 'Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time', 'compression depth', 'mean compression depth', 'CPR parameters, including compression depth and hands-off time', 'CPR quality']","[{'cui': 'C0016129', 'cui_str': 'Fingers'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0335367', 'cui_str': 'Presser (hand) (occupation)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0644301,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,"[{'ForeName': 'Joong Wan', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Joonghee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Kwak', 'Affiliation': ''}, {'ForeName': 'Do Kyun', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jung Chan', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Ham', 'Affiliation': ''}, {'ForeName': 'Soyun', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Hyuksool', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1471559']
3207,30380175,"Modulating neural oscillations by transcranial static magnetic field stimulation of the dorsolateral prefrontal cortex: A crossover, double-blind, sham-controlled pilot study.","Transcranial static magnetic field stimulation (tSMS) is a novel non-invasive brain stimulation technique that has been shown to locally increase alpha power in the parietal and occipital cortex. We investigated if tSMS locally increased alpha power in the left or right prefrontal cortex, as the balance of left/right prefrontal alpha power (frontal alpha asymmetry) has been linked to emotional processing and mood disorders. Therefore, altering frontal alpha asymmetry with tSMS may serve as a novel treatment to psychiatric diseases. We performed a crossover, double-blind, sham-controlled pilot study to assess the effects of prefrontal tSMS on neural oscillations. Twenty-four right-handed healthy participants were recruited and received left dorsolateral prefrontal cortex (DLPFC) tSMS, right DLPFC tSMS, and sham tSMS in a randomized order. Electroencephalography data were collected before (2 min eyes-closed, 2 min eyes-open), during (10 min eyes-open), and after (2 min eyes-open) stimulation. In contrast with our hypothesis, neither left nor right tSMS locally increased frontal alpha power. However, alpha power increased in occipital cortex during left DLPFC tSMS. Right DLPFC tSMS increased post-stimulation fronto-parietal theta power, indicating possible relevance to memory and cognition. Left and right DLPFC tSMS increased post-stimulation left hemisphere beta power, indicating possible changes to motor behavior. Left DLPFC tSMS also increased post-stimulation right frontal beta power, demonstrating complex network effects that may be relevant to aggressive behavior. We concluded that DLPFC tSMS modulated the network oscillations in regions distant from the location of stimulation and that tSMS has region specific effects on neural oscillations.",2019,"In contrast with our hypothesis, neither left nor right tSMS locally increased frontal alpha power.",['Twenty-four right-handed healthy participants'],"['left dorsolateral prefrontal cortex (DLPFC', 'transcranial static magnetic field stimulation', 'DLPFC tSMS', 'tSMS, right DLPFC tSMS, and sham tSMS', 'prefrontal tSMS', 'Transcranial static magnetic field stimulation (tSMS']","['Electroencephalography data', 'neural oscillations']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}]",24.0,0.0669403,"In contrast with our hypothesis, neither left nor right tSMS locally increased frontal alpha power.","[{'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Sheffield', 'Affiliation': 'Neuroscience Program, Colorado College, Colorado Springs, Colorado.'}, {'ForeName': 'Sangtae', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Sankaraleengam', 'Initials': 'S', 'LastName': 'Alagapan', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",The European journal of neuroscience,['10.1111/ejn.14232']
3208,31569275,Home versus laboratory assessments of melatonin production and melatonin onset in young adults complaining of a delayed sleep schedule.,"Recent evidence points toward an association between higher non-visual sensitivity to light and a later circadian phase in young adults complaining of a delayed sleep schedule. Light exposure in the evening may therefore induce a larger suppression of melatonin production in these individuals, which might: (a) bias home estimates of melatonin onset; and (b) decrease sleep propensity at bedtime. In this study, we compared home and laboratory melatonin onsets and production in sleep-delayed and control participants, using saliva samples collected in the 3 hr preceding habitual bedtime. The mean light intensity measured during saliva sampling at home was ~10 lux in both groups. Melatonin suppression at home was significant, averaging 31% and 24% in sleep-delayed and control individuals, respectively. Group difference in melatonin suppression was not significant. Estimates of melatonin onset were on average 27 min later at home than in laboratory conditions, with no group difference. Looking specifically at sleep-delayed participants, there was no correlation between non-visual sensitivity to light and home-laboratory differences in melatonin onsets. However, higher light sensitivity was associated with greater melatonin suppression in the hour before habitual bedtime. Greater melatonin suppression before bedtime was also associated with a later circadian phase. These results indicate that the validity of home estimates of melatonin onset is similar in sleep-delayed and in control individuals. Results also suggest that increased non-visual sensitivity to light could impact melatonin secretion in sleep-delayed individuals and contribute to a late bedtime by delaying circadian phase and decreasing sleep propensity.",2020,"Looking specifically at sleep-delayed participants, there was no correlation between non-visual sensitivity to light and home-laboratory differences in melatonin onsets.","['sleep-delayed and control participants, using saliva samples collected in the 3\xa0hr preceding habitual bedtime', 'young adults complaining of a delayed sleep schedule']",[],"['Melatonin suppression', 'higher light sensitivity', 'Greater melatonin suppression', 'mean light intensity', 'melatonin suppression']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]",[],"[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]",,0.0726218,"Looking specifically at sleep-delayed participants, there was no correlation between non-visual sensitivity to light and home-laboratory differences in melatonin onsets.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Moderie', 'Affiliation': 'Center for Advanced Research in Sleep Medicine, Sacre-Coeur Hospital of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Solenne', 'Initials': 'S', 'LastName': 'Van der Maren', 'Affiliation': 'Center for Advanced Research in Sleep Medicine, Sacre-Coeur Hospital of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paquet', 'Affiliation': 'Center for Advanced Research in Sleep Medicine, Sacre-Coeur Hospital of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dumont', 'Affiliation': 'Center for Advanced Research in Sleep Medicine, Sacre-Coeur Hospital of Montreal, Montreal, QC, Canada.'}]",Journal of sleep research,['10.1111/jsr.12905']
3209,31611105,A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.,"OBJECTIVE


Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts.
METHODS


In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.
RESULTS


At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted.
CONCLUSIONS


Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.",2020,"No difference in anatomic or clinical success was observed; no major complications were noted.
","['venous anastomotic stenosis of dialysis arteriovenous grafts', '44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n\xa0= 22) or CBs (n\xa0= 22) from July 2015 to August 2018', 'native arteriovenous (AV) fistulas']","['Paclitaxel-coated balloons', 'drug-coated balloon angioplasty', 'angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs']","['neointimal hyperplasia', 'primary patency of venous anastomotic stenosis and all dialysis AV grafts', 'primary patency of the entire access circuit', 'target lesion primary patency', 'anatomic or clinical success', 'anatomic and clinical success after angioplasty, circuit primary patency at 6\xa0months and 1\xa0year, and target lesion primary patency at 1\xa0year', 'venous anastomotic stenosis of dialysis grafts', 'Access function']","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.109425,"No difference in anatomic or clinical success was observed; no major complications were noted.
","[{'ForeName': 'Min-Tsun', 'Initials': 'MT', 'LastName': 'Liao', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Cheng-Pin', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Ting-Tse', 'Initials': 'TT', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chien-Boon', 'Initials': 'CB', 'LastName': 'Jong', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Tsung-Yan', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Mu-Yang', 'Initials': 'MY', 'LastName': 'Hsieh', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Mao-Shin', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan; School of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Cheng', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institute, Miaoli, Taiwan. Electronic address: chihchengwumd@gmail.com.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.07.090']
3210,31228055,Automated Self-management (ASM) vs. ASM-Enhanced Collaborative Care for Chronic Pain and Mood Symptoms: the CAMMPS Randomized Clinical Trial.,"BACKGROUND


Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions.
OBJECTIVE


To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care.
DESIGN


Randomized clinical trial conducted in six primary care clinics in a VA medical center.
PARTICIPANTS


Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms.
INTERVENTION


ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months.
MAIN MEASURES


Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use.
KEY RESULTS


Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = - 0.65 and - 0.52, respectively). Compared to the ASM group, the CSM group had a - 0.23 (95% CI, - 0.38 to - 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013).
CONCLUSIONS


Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT0175730.",2019,"CONCLUSIONS


Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms.","['six primary care clinics in a VA medical center', 'Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms']","['CSM', 'ASM', 'CSM and ASM', 'Comprehensive symptom management (CSM) combined ASM', 'Automated Self-management (ASM) vs. ASM-Enhanced Collaborative Care', 'automated self-management (ASM) vs. ASM', 'ASM consisted of automated monitoring and 9 web-based self-management modules']","['global improvement, health-related quality of life, treatment satisfaction, and health services use', 'composite PAD z-score', 'moderate PAD score improvement', 'composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores', 'pain and mood symptoms']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]","[{'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",294.0,0.169808,"CONCLUSIONS


Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA. kkroenke@regenstrief.org.'}, {'ForeName': 'Fitsum', 'Initials': 'F', 'LastName': 'Baye', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Spencer G', 'Initials': 'SG', 'LastName': 'Lourens', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Weitlauf', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McCalley', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Matthias', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05121-4']
3211,30607570,Randomized Double-Blind Controlled Study on the Safety and Efficacy of a Novel Injectable Cross-linked Hyaluronic Gel for the Correction of Moderate-to-Severe Nasolabial Wrinkles.,"INTRODUCTION


The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles.
MATERIALS AND METHODS


This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness.
RESULTS


Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student's t test: p = 0.2181). No significant differences were observed with regard to the subject's satisfaction and adverse events.
CONCLUSIONS


The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,"At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them.","['Moderate-to-Severe Nasolabial Wrinkles', 'subjects with bilateral nasolabial wrinkles']","['hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance', 'Novel Injectable Cross-linked Hyaluronic Gel']","[""subject's satisfaction and adverse events"", 'quantity of product injected and any problems or local reactions (erythema, edema, pain or itching', 'Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS', 'Safety and Efficacy', 'WSRS and GAIS score', 'skin thickness']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0527088,"At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Fino', 'Affiliation': 'Department of Surgery ""P.Valdoni"", UOC of Plastic Surgery, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy. pasquale.fino@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Toscani', 'Affiliation': 'Department of Surgery ""P.Valdoni"", UOC of Plastic Surgery, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Francesca Romana', 'Initials': 'FR', 'LastName': 'Grippaudo', 'Affiliation': ""Plastic Surgery Unit, Sapienza University of Rome, Sant'Andrea, Rome, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giordan', 'Affiliation': 'Clinical Research Department, Fidia Farmaceutici S.p.A., Abano Terme, Padua, Italy.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Scuderi', 'Affiliation': 'Department of Surgery ""P.Valdoni"", UOC of Plastic Surgery, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-018-1284-x']
3212,31665610,The effects of aerobic exercise intensity on memory in older adults.,"Aerobic exercise may enhance memory in older adults. However, the optimal intensity and underlying mechanism are unclear. This community-based study examined the effect of aerobic exercise intensity on memory and general cognitive abilities. Brain-derived neurotrophic factor (BDNF) was examined as a potential mechanism. Sixty-four sedentary older adults participated in 1 of 3 groups: ( i ) high-intensity interval training (HIIT); ( ii ) moderate continuous training (MCT); or ( iii ) stretching control (CON). Prior to and following the intervention, high-interference memory was assessed using a Mnemonic Similarity task and executive functions were assessed using Go Nogo and Flanker tasks. HIIT led to the greatest memory performance compared with MCT and CON ( F [2,55]  = 6.04,  p  = 0.004) and greater improvements in memory correlated with greater increases in fitness ( r s  (46) = 0.27,  p  = 0.03). Exercise intensity seemed to matter less for executive functioning, as positive trends were observed for both HIIT and MCT. No significant differences in BDNF were found between groups. Overall, these results suggest that aerobic exercise may enhance memory in older adults, with the potential for higher intensity exercise to yield the greatest benefit. While our findings suggest that BDNF does not regulate these adaptations, the mechanisms remain to be determined.  Novelty  High-intensity interval training results in the greatest memory performance in inactive older adults compared with moderate continuous training or stretching. Improvement in fitness correlates with improvement in memory performance.",2020,"HIIT led to the greatest memory performance compared to MCT and CON [F(2, 55) =","['Sixty-four sedentary older adults participated in one of three groups: 1', 'older adults', 'inactive older adults']","['BDNF', 'moderate continuous training or stretching •', 'high-intensity interval training (HIIT); 2) moderate continuous training (MCT); or 3) stretching control (CON', 'Novelty bullets: • High-intensity interval training', 'Aerobic exercise', 'aerobic exercise', 'aerobic exercise intensity']","['Mnemonic Similarity task and executive functions', 'memory and general cognitive abilities', 'memory performance', 'BDNF']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",64.0,0.0408448,"HIIT led to the greatest memory performance compared to MCT and CON [F(2, 55) =","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fenesi', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Paolucci', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0495']
3213,30869991,The effectiveness of acupressure in the management of depressive symptoms and in improving quality of life in older people living in the community: a randomised sham-controlled trial.,"Objective:  The primary aim of the current trial was to assess the clinical effectiveness of acupressure in the management of depression in elderly people compared to patients receiving sham acupressure or standard care alone. Methods:  Randomized sham-controlled trial of acupressure, sham acupressure and standard care alone in older patients with depression living in the community. Patients with a score>/=8 in the Geriatric Depression Scale were recruited for this study. Intervention/sham treatments were provided four times/week for three months. Assessments related to depressive symptoms (primary outcome), well-being, resilience, spirituality and quality of life domains were carried out at baseline, end of the intervention and three-months after the intervention. Results:  118 patients were randomized to intervention (n = 40), sham (n = 40) or control arm (n = 38), with 84 patients providing final analysis data. Significant reduction in mean score of depressive symptoms was found in the acupressure group (from 10.6 (sd = 0.03) to 7.7 (sd = 0.07), p < 0.001 at end of intervention and 8.7 (sd = 0.8), p = 0.002 at follow-up) and the sham acupressure group (from 10.5 (sd = 0.3) to 8.4 (sd = 0.8), p = 0.005) at end of intervention and 8.4 (sd = 0.8), p = 0.006 at follow-up but not in the control group (from 10.8 to 9.9, p = 0.20). Resilience (p = 0.02) and spirituality (p = 0.02) were also improved in the intervention group at the end of intervention assessment but this change was not sustained at follow-up. Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group. The sham group showed additional improvements in daily functioning and environmental quality of life. Conclusions:  Although acupressure improved outcomes, a placebo effect was evident. Acupressure may be an effective approach to manage depression in elderly patients, but more evidence is needed in the future before it can be recommended for practice as well as more clear elucidation of any placebo effects.",2020,Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group.,"['elderly patients', 'older patients with depression living in the community', '118 patients', 'elderly people compared to patients receiving', 'older people living in the community', 'Patients with a score>/=8 in the Geriatric Depression Scale']","['acupressure', 'sham acupressure or standard care alone', 'acupressure, sham acupressure and standard care alone', 'Acupressure']","['depressive symptoms (primary outcome), well-being, resilience, spirituality and quality of life domains', 'quality of life', 'daily functioning and environmental quality of life', 'mean score of depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",118.0,0.16033,Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lai', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Karen Hong Yun', 'Initials': 'KHY', 'LastName': 'Wat', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Kui-Lung', 'Initials': 'KL', 'LastName': 'To', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Cheung-On', 'Initials': 'CO', 'LastName': 'Leung', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Chinese University of Hong Kong, Hong Kong SAR.'}]",Aging & mental health,['10.1080/13607863.2019.1584789']
3214,30721940,Falls After Hospital Discharge: A Randomized Clinical Trial of Individualized Multimodal Falls Prevention Education.,"BACKGROUND


Older people are at high risk of falls after hospital discharge. The study aimed to evaluate the effect of providing individualized falls prevention education in addition to usual care on falls rates in older people after hospital discharge compared to providing a social intervention in addition to usual care.
METHODS


A randomized clinical trial at three hospitals in Western Australia: participants followed for 6 months after discharge. Baseline and outcomes measured by assessors masked to group allocation. Participants: aged 60 years and over, admitted for rehabilitation. Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10). Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist. Main outcomes: falls in the 6 months after discharge; proportion of participants sustaining one or more falls.
RESULTS


There were 382 (194 intervention; 188 control) participants (mean age 77.7 [SD 8.7] years). There were 378 falls (fall rate per 1,000 patient-days, 5.9 intervention; 5.9 control) reported by 164 (42.9%) participants in the 6 months following hospital discharge; 188 (49.7%) of these falls were injurious. There were no significant differences in falls rates between intervention and control groups: (adjusted IRR, 1.09; 95% CI [0.78 to 1.52]) or the proportion of participants who fell once or more (adjusted OR, 1.37; 95% CI [0.90 to 2.07]).
CONCLUSIONS


Providing individualized falls prevention education prior to discharge did not reduce falls at home after discharge. Further research is warranted to investigate how to reduce falls during this high-risk transition period.",2019,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)].
","['older people after hospital discharge', 'Falls after hospital discharge', 'There were 382 (194 intervention; 188 control) participants [mean age 77.7 (SD 8.7) years', 'Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10', 'Participants: aged 60 years and over, admitted for rehabilitation']","['social intervention', 'individualized multi-modal', 'individualized falls prevention education', 'Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist']","['discharge; proportion of participants sustaining one or more falls', 'falls rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2960765', 'cui_str': 'Abbreviated mental test score'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",,0.217539,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)].
","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope and La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, Geriatric Research Education and Clinical Center (GRECC), Gainesville, Florida.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Waldron', 'Affiliation': 'Department of Aged Care and Rehabilitation, Armadale Kelmscott Memorial Hospital, East Metropolitan Health Service, Armadale, Western Australia, Australia.'}, {'ForeName': 'Den-Ching A', 'Initials': 'DA', 'LastName': 'Lee', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Francis-Coad', 'Affiliation': 'School of Physiotherapy, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Boudville', 'Affiliation': 'Department of Aged Care and Rehabilitation, St John of God Midland Public and Private Hospital, Midland, Western Australia, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz026']
3215,30578394,Phase 2 clinical trial of PBI-4050 in patients with idiopathic pulmonary fibrosis.,"PBI-4050 is a novel orally active small-molecule compound with demonstrated anti-fibrotic activity in several models of fibrosis, including lung fibrosis. We present results from our first clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF).This 12-week open-label study explored the safety, efficacy and pharmacokinetics of daily oral doses of 800 mg PBI-4050 alone and in combination with nintedanib or pirfenidone in patients with predominantly mild or moderate IPF. Nine patients received PBI-4050 alone, 16 patients received PBI-4050 with nintedanib and 16 patients received PBI-4050 with pirfenidone.PBI-4050 alone or in combination with nintedanib or pirfenidone was well tolerated. Pharmacokinetic profiles for PBI-4050 were similar in the PBI-4050 alone and PBI-4050+nintedanib groups but reduced in the PBI-4050+pirfenidone group, suggesting a drug-drug interaction. There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib. In contrast, a statistically significant reduction (p<0.024) in FVC % pred was seen for PBI-4050+pirfenidone after 12 weeks.There were no safety concerns with PBI-4050 alone or in combination with nintedanib or pirfenidone in IPF patients. The stability of FVC between baseline and week 12 looked encouraging for PBI-4050 alone and in combination with nintedanib.",2019,"There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib.","['patients with predominantly mild or moderate IPF', 'patients with idiopathic pulmonary fibrosis', 'IPF patients']","['PBI-4050', 'PBI-4050 alone and in combination with nintedanib or pirfenidone', 'PBI-4050 alone or in combination with nintedanib or pirfenidone', 'PBI-4050 with nintedanib', 'PBI-4050 with pirfenidone']","['forced vital capacity (FVC', 'tolerated', 'Pharmacokinetic profiles for PBI-4050', 'safety, efficacy and pharmacokinetics', 'stability of FVC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0159725,"There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib.","[{'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Khalil', 'Affiliation': 'Vancouver General Hospital - The Lung Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Manganas', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Ryerson', 'Affiliation': ""Dept of Medicine, University of British Columbia and Centre for Heart Lung Innovation, St.\xa0Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Shapera', 'Affiliation': 'University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andre M', 'Initials': 'AM', 'LastName': 'Cantin', 'Affiliation': 'Centre de Recherche Clinique du Centre Hospitalier Universitaire de Sherbrooke (CHUS-CRC), Sherbrooke, QC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hernandez', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Turcotte', 'Affiliation': ""Centre d'Imagerie Moléculaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Parker', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Moran', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Albert', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Sawtell', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Hagerimana', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurin', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Lyne', 'Initials': 'L', 'LastName': 'Gagnon', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cesari', 'Affiliation': 'Prometic Life Sciences Inc., Laval, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': ""Firestone Institute for Respiratory Health, St.\xa0Joseph's Healthcare, Hamilton, ON, Canada kolbm@mcmaster.ca.""}]",The European respiratory journal,['10.1183/13993003.00663-2018']
3216,31679069,Early mobilization does not reduce the risk of deep venous thrombosis after Achilles tendon rupture: a randomized controlled trial.,"PURPOSE


The hypothesis was that early functional mobilization would reduce the incidence of deep venous thrombosis (DVT) during leg immobilization after Achilles tendon rupture surgery. A secondary aim was to evaluate if the amount of weightbearing and daily steps influenced the risk of sustaining a DVT.
METHODS


One-hundred and fifty patients with Achilles tendon rupture repair were randomized to treatment with early functional mobilization, encouraging full weightbearing and ankle motion in orthosis, or treatment-as-usual, i.e., 2 weeks of unloading in plaster cast followed by 4 weeks weightbearing in orthosis. At 2 and 6 weeks postoperatively, all patients were screened for DVT using compression duplex ultrasound. During the first 2 weeks postoperatively, patient-reported loading, pain and step counts were assessed.
RESULTS


At 2 weeks, 28/96 (29%) of the patients in early functional mobilization group and 15/49 (31%) in the control group (n.s) had sustained a DVT. At 6 weeks, the DVT rate was 35/94 (37%) in the early functional mobilization and 14/49 (29%) in the control group (n.s). During the first postoperative week, the early functional mobilization group reported low loading and higher experience of pain vs. the control group (p = 0.001). Low patient-reported loading ≤ 50% (OR = 4.3; 95% CI 1.28-14.3) was found to be an independent risk factor for DVT, in addition to high BMI and higher age.
CONCLUSIONS


Early functional mobilization does not prevent the high incidence of DVT during leg immobilization in patients with Achilles tendon rupture as compared to treatment-as-usual. The low efficacy of early functional mobilization is mainly explained by postoperative pain and subsequent low weightbearing. To minimize the risk of DVT, patients should be encouraged to load at least 50% of body weight on the injured leg 1 week after surgery.
LEVEL OF EVIDENCE


Therapeutic, level 1.",2020,"Low patient-reported loading ≤ 50% (OR = 4.3; 95% CI 1.28-14.3) was found to be an independent risk factor for DVT, in addition to high BMI and higher age.
","['Achilles tendon rupture', 'One-hundred and fifty patients with Achilles tendon rupture repair', 'patients with Achilles tendon rupture']","['early functional mobilization, encouraging full weightbearing and ankle motion in orthosis, or treatment-as-usual, i.e., 2\xa0weeks of unloading in plaster cast followed by 4\xa0weeks weightbearing in orthosis']","['loading, pain and step counts', 'DVT rate', 'incidence of deep venous thrombosis (DVT', 'sustained a DVT', 'low loading and higher experience of pain']","[{'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032159', 'cui_str': 'Plaster Casts'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1318107', 'cui_str': 'Loadbearing'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",150.0,0.111874,"Low patient-reported loading ≤ 50% (OR = 4.3; 95% CI 1.28-14.3) was found to be an independent risk factor for DVT, in addition to high BMI and higher age.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Aufwerber', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden. susanna.aufwerber@ki.se.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Heijne', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Edman', 'Affiliation': 'R&D, Norrtälje Hospital, Tiohundra AB, Norrtälje, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Grävare Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Ackermann', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05767-x']
3217,30878302,"Re: Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.155659,,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology, University Hospital of Würzburg, Julius-Maximillians University, Würzburg, Germany. Electronic address: georgios.gakis@googlemail.com.'}]",European urology,['10.1016/j.eururo.2019.02.034']
3218,31887277,Magnetic Resonance-Based Diagnostics for Bleeding Assessment in Neonatal Cardiac Surgery.,"PURPOSE


Infants undergoing a cardiac operation are at high risk for postsurgical bleeding. To date, there are no highly predictive models for postsurgical bleeding in this population. This study's objective was to assess the predictive ability of T2 magnetic resonance (T2MR).
DESCRIPTION


T2MR uses magnetic resonance to detect clot formation characteristics on a small blood sample and provides hemostatic indicators that can assess bleeding risk.
EVALUATION


This prospective, single-institution study enrolled 100 patients younger than 12 months old undergoing a cardiac operation from April 27, 2015, to September 21, 2016. The primary end point was postsurgical bleeding within 24 hours after the procedure. T2MR data were modeled with a binary recursive partitioning algorithm with randomized cross-validation. The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator characteristic curve, 0.64; classification accuracy, 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting (Salford Systems, San Diego, CA). Multivariate modeling with cross-validation showed mean receiver operator characteristic curve area of 0.74 and classification accuracy of 82%.
CONCLUSIONS


T2MR tight clot and platelet function metrics were associated with bleeding events.",2020,"The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator curve = 0.64, classification accuracy = 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting.","['Infants undergoing cardiac surgery', '100 patients less than 12 months old undergoing cardiac surgery from 4/27/2015 and 9/21/2016', 'Neonatal Cardiac Surgery']","['Magnetic Resonance-Based Diagnostics', 'T2 magnetic resonance (T2MR']",['post-surgical bleeding'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",100.0,0.0527928,"The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator curve = 0.64, classification accuracy = 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting.","[{'ForeName': 'Perry S', 'Initials': 'PS', 'LastName': 'Choi', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sirisha', 'Initials': 'S', 'LastName': 'Emani', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ibla', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Marturano', 'Affiliation': 'T2 Biosystems, Lexington, Massachusetts.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Lowery', 'Affiliation': 'T2 Biosystems, Lexington, Massachusetts.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Emani', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts. Electronic address: sitaram.emani@cardio.chboston.org.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.11.010']
3219,30872114,A randomized clinical trial to evaluate home-based assessment of people over 75 years old.,"INTRODUCTION


There is an unmet need for effective methods for conducting dementia prevention trials.
METHODS


Home-based assessment study compared feasibility and efficiency, ability to capture change over time using in-home instruments, and ability to predict cognitive conversion using predefined triggers in a randomized clinical trial in (1) mail-in questionnaire/live telephone interviews, (2) automated telephone/interactive voice recognition, and (3) internet-based computer Kiosk technologies. Primary endpoint was defined as cognitive conversion.
RESULTS


Analysis followed a modified intent-to-treat principle. Dropout rates were low and similar across technologies but participants in Kiosk were more likely to dropout earlier. Staff resources needed were higher in Kiosk. In-home instruments distinguished conversion and stable groups. Cognitively stable group showed improvement in cognitive measures. Triggering was associated with higher likelihood of conversion but statistically significant only in mail-in questionnaire/live telephone interviews.
DISCUSSION


Relatively low efficiency of internet-based assessment compared with testing by live-assessors has implications for internet-based recruitment and assessment efforts currently proposed for diverse populations.",2019,Cognitively stable group showed improvement in cognitive measures.,['people over 75\xa0years old'],"['mail-in questionnaire/live telephone interviews, (2) automated telephone/interactive voice recognition, and (3) internet-based computer Kiosk technologies']","['cognitive conversion', 'cognitive measures', 'Dropout rates']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0484648,Cognitively stable group showed improvement in cognitive measures.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sano', 'Affiliation': 'Department of Psychiatry, Alzheimer Disease Research Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA; James J Peters VAMC, Bronx, NY, USA. Electronic address: mary.sano@mssm.edu.'}, {'ForeName': 'Carolyn W', 'Initials': 'CW', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Alzheimer Disease Research Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA; James J Peters VAMC, Bronx, NY, USA; Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': 'Department of Neurology and Biomedical Engineering, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Mundt', 'Affiliation': 'Wisconsin Department of Health Services, Division of Care and Treatment Services, Mauston, WI, USA.'}, {'ForeName': 'Tamara L', 'Initials': 'TL', 'LastName': 'Hayes', 'Affiliation': 'Oregon Center for Aging and Technology, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ferris', 'Affiliation': 'Center for Cognitive Neurology, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'Department of Neurosciences, San Diego, CA, USA; Department of Family and Preventive Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Chung-Kai', 'Initials': 'CK', 'LastName': 'Sun', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, CA, USA.""}, {'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, CA, USA.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, CA, USA.""}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Egelko', 'Affiliation': 'Department of Psychiatry, Alzheimer Disease Research Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, CA, USA.""}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Feldman', 'Affiliation': 'Department of Neurosciences, University of California, San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.01.007']
3220,29423885,Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.,"PURPOSE


To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.
METHODS


A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25-69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.
RESULTS


At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.
CONCLUSION


Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.",2018,"CONCLUSION


Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls.","['All patients had Type I or Type II Modic changes of the treated vertebral bodies', 'A total of 225 patients diagnosed with CLBP', 'The mean age within the study was 47\xa0years (range 25-69) and the mean baseline ODI was 42', 'chronic low back pain (CLBP', 'chronic low back pain']","['BVN ablation', 'Intraosseous basivertebral nerve ablation', 'radiofrequency (RF) ablation of the basivertebral nerve (BVN']","['safety and efficacy', 'ODI decrease ≥\xa010 points', 'comparative change in ODI', 'average ODI', 'ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",225.0,0.171696,"CONCLUSION


Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Fischgrund', 'Affiliation': 'Department of Orthopedic Surgery, Oakland University William Beaumont School of Medicine, 3535 West 13 Mile Road, Suite 744, Royal Oak, MI, 48073, USA. jsfischgrund37@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rhyne', 'Affiliation': 'Ortho Carolina Spine Center, Charlotte, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Franke', 'Affiliation': 'Department of Orthopedics-Spine and Pediatric Orthopedics, Klinikum Magdeburg GmbH, Magdeburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sasso', 'Affiliation': 'Department of Orthopedic Surgery, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kitchel', 'Affiliation': 'NeuroSpine Institute, Eugene, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Cedars Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yeung', 'Affiliation': 'Desert Institute for Spine Care, Phoenix, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Truumees', 'Affiliation': 'Seton Spine and Scoliosis Center, Seton Medical Center, Brackenridge University Hospital, Austin, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schaufele', 'Affiliation': 'Pain Solutions Treatment Centers, Marietta, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Long Beach Memorial Medical Center, Long Beach, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité-Universitaetsmedizin Berlin, Campus Virchow Medical Center, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, Richmond, USA.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Anderson', 'Affiliation': 'Departments of Orthopaedic and Neurological Surgery, Thomas Jefferson University, Philadelphia, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Thibodeau', 'Affiliation': 'Maine Spine Surgery, Portland, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Direktor der Neurochirurgischen Klinik und Poliklinik, Klinikum Rechts der Isar, Munich, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-018-5496-1']
3221,30878999,Rationale for Raising Current Clinical Practice Guideline Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease.,"BACKGROUND


Vitamin D repletion is recommended for secondary hyperparathyroidism (SHPT) and associated vitamin D insufficiency (VDI) in chronic kidney disease (CKD), but optimal levels of serum total 25-hydroxyvitamin D remain undefined. Clinical practice guidelines target sufficiency, whereas recent data indicate that higher levels are required to control the elevation of intact parathyroid hormone (iPTH) as CKD advances. This secondary analysis of 2 randomized controlled trials seeks to identify the minimum level of mean serum 25-hydroxyvitamin D required to control SHPT arising from VDI in stage 3 or 4 CKD.
METHODS


Adult subjects (n = 429) with SHPT, VDI, and stage 3 or 4 CKD were stratified by stage and treated daily with either extended-release calcifediol (ERC) or placebo in 2 identical, parallel, randomized, double-blind studies. After treatment for 26 weeks, all subjects were ranked by the level of serum total 25-hydroxyvitamin D and divided into quintiles in order to examine the relationships between the degree of vitamin D repletion and the associated changes in plasma iPTH, serum bone turnover markers, calcium, phosphorus, intact fibroblast growth factor 23 (FGF23) and vitamin D metabolites, estimated glomerular filtration rate (eGFR), and urine calcium:creatinine (Ca:Cr) ratio.
RESULTS


Progressive increases in serum 1,25-dihydroxyvitamin D and reductions in plasma iPTH and serum bone turnover markers were observed as mean posttreatment serum 25-hydroxyvitamin D rose from 13.9 ng/mL (in Quintile 1) to 92.5 ng/mL (in Quintile 5), irrespective of CKD stage. Mean serum calcium, phosphorus and FGF23, eGFR, and urine Ca:Cr ratio (collectively ""safety parameters"") did not significantly change from Quintile 1. Suppression of iPTH and bone turnover markers was not observed until serum 25-hydroxyvitamin D rose to at least 50.8 ng/mL (Quintile 3).
CONCLUSION


ERC therapy produced exposure-dependent reductions in plasma iPTH and bone turnover markers only when mean serum total 25-hydroxyvitamin D reached at least 50.8 ng/mL, indicating that current targets for vitamin D repletion therapy in CKD are too low. Gradual elevation of mean serum 25-hydroxyvitamin D to 92.5 ng/mL was not associated with significant adverse changes in safety parameters.",2019,"CONCLUSION


ERC therapy produced exposure-dependent reductions in plasma iPTH and bone turnover markers only when mean serum total 25-hydroxyvitamin D reached at least 50.8 ng/mL, indicating that current targets for vitamin D repletion therapy in CKD are too low.","['Chronic Kidney Disease', 'Adult subjects (n = 429) with SHPT, VDI, and stage 3 or 4 CKD were stratified by stage and treated daily with either']","['extended-release calcifediol (ERC) or placebo', '25-hydroxyvitamin D']","['level of serum total 25-hydroxyvitamin D', 'serum 25-hydroxyvitamin D', 'Mean serum calcium, phosphorus and FGF23, eGFR, and urine Ca:Cr ratio (collectively ""safety parameters', 'mean serum 25-hydroxyvitamin D', 'serum 1,25-dihydroxyvitamin D and reductions in plasma iPTH and serum bone turnover markers', 'serum total 25-hydroxyvitamin D', 'Gradual elevation of mean serum', 'plasma iPTH, serum bone turnover markers, calcium, phosphorus, intact fibroblast growth factor 23 (FGF23) and vitamin D metabolites, estimated glomerular filtration rate (eGFR), and urine calcium:creatinine (Ca:Cr) ratio', 'plasma iPTH and bone turnover markers', 'Suppression of iPTH and bone turnover markers']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0042037'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3811844'}, {'cui': 'C0428303', 'cui_str': 'Calcium measurement, urine (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",429.0,0.15955,"CONCLUSION


ERC therapy produced exposure-dependent reductions in plasma iPTH and bone turnover markers only when mean serum total 25-hydroxyvitamin D reached at least 50.8 ng/mL, indicating that current targets for vitamin D repletion therapy in CKD are too low.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Strugnell', 'Affiliation': 'Renal Division, OPKO Health, Inc., Miami, Florida, USA, sstrugnell@opko.com.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois, USA.'}, {'ForeName': 'Akhtar', 'Initials': 'A', 'LastName': 'Ashfaq', 'Affiliation': 'Renal Division, OPKO Health, Inc., Miami, Florida, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Petkovich', 'Affiliation': ""Department of Biomedical and Molecular Sciences, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Bishop', 'Affiliation': 'Renal Division, OPKO Health, Inc., Miami, Florida, USA.'}]",American journal of nephrology,['10.1159/000499187']
3222,30922612,An in vitro investigation of the inflammatory response to the strain amplitudes which occur during high frequency oscillation ventilation and conventional mechanical ventilation.,"Children randomised in the neonatal period to high frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CMV) in the United Kingdom Oscillation study (UKOS) had superior lung function at 11 to 14 years of age. During HFOV, much smaller tidal volumes, but a higher mean airway distending pressure is delivered, hence, a possible explanation for a volume dependent effect on long term lung function could be an increase in inflammation in response to higher tidal volumes and strains. We tested that hypothesis by assessing interleukin-6 (IL-6) and -8 (IL-8) release from A549 alveolar analogue cells following biaxial mechanical strain applied at 0.5 Hz occurring during conditions mimicking strain during CMV (5-20% strain) and conditions mimicking strain during HFOV (17.5% ± 2.5% strain) for up to 4 h. Cyclic strain of 5-20%, occurring during CMV, increased levels of both IL-6 and IL-8 compared to unstrained controls, while 17.5% ± 2.5% strain, occurring during HFOV, was associated with significantly lower levels of IL-6 (46.31 ± 2.66 versus 56.79 ± 3.73 pg/mL) and IL-8 (1340.2 ± 74.9 versus 2522 ± 248 pg/mL) secretion compared to conditions occurring during CMV at four hours. These results may provide a possible explanation for the superior lung function in 11-14-year-old children who had been supported in the neonatal period by HFOV.",2019,IL-8 (1340.2 ± 74.9 versus 2522 ± 248 pg/mL) secretion compared to conditions occurring during CMV at four hours.,['11-14-year-old children who had been supported in the neonatal period by HFOV'],['neonatal period to high frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CMV'],"['levels of IL-6', 'IL-8', 'interleukin-6 (IL-6) and -8 (IL-8) release', 'levels of both IL-6 and IL-8']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",,0.072966,IL-8 (1340.2 ± 74.9 versus 2522 ± 248 pg/mL) secretion compared to conditions occurring during CMV at four hours.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': ""MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, United Kingdom; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, Kings College London, London, United Kingdom.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Thorpe', 'Affiliation': 'Institute of Bioengineering, School of Engineering and Materials Science, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rushwan', 'Affiliation': ""MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, United Kingdom; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, Kings College London, London, United Kingdom.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, United Kingdom; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, Kings College London, London, United Kingdom.""}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Thompson', 'Affiliation': 'Institute of Bioengineering, School of Engineering and Materials Science, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""Division of Health and Social Care Research, King's College London, London, United Kingdom; NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London, London, United Kingdom.""}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Knight', 'Affiliation': 'Institute of Bioengineering, School of Engineering and Materials Science, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Bibek', 'Initials': 'B', 'LastName': 'Gooptu', 'Affiliation': ""MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, United Kingdom; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, Kings College London, London, United Kingdom; Institute for Lung Health, University of Leicester, Leicester, United Kingdom.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, United Kingdom; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, Kings College London, London, United Kingdom; NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London, London, United Kingdom. Electronic address: anne.greenough@kcl.ac.uk.""}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.03.024']
3223,30736083,Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.,"BACKGROUND


Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of  Capsicum frutescens  L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy  Malagueta .
METHODS


This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine  Malagueta  (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group.
RESULTS


The effect of  Malagueta  on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4,  p  < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with  Malagueta , compared with placebo, also reduced the intensity of the secondary symptoms ( p  = 0.001) and improved level of activity ( p  = 0.025) and well-being ( p  = 0.008).
CONCLUSION


The homeopathic medicine of  Capsicum frutescens  ( Malagueta ) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.",2019,"Treatment with  Malagueta , compared with placebo, also reduced the intensity of the secondary symptoms ( p  = 0.001) and improved level of activity ( p  = 0.025) and well-being ( p  = 0.008).
","['menopausal women after 4 weeks of treatment', 'Hot Flashes in Menopausal Women', 'A total of 40 women were enrolled in the study, 20 in each group', 'menopausal women, the homeopathic medicine  Malagueta  (30 CH']","['Hormone replacement therapy', 'Homeopathic Medicine of Capsicum frutescens L. (Solanaceae', 'placebo']","['intensity of the secondary symptoms', 'intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument', 'level of activity', 'intensity of hot flashes']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}]","[{'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C0006932', 'cui_str': 'Capsicum'}, {'cui': 'C0446224', 'cui_str': 'Solanaceae'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",40.0,0.47075,"Treatment with  Malagueta , compared with placebo, also reduced the intensity of the secondary symptoms ( p  = 0.001) and improved level of activity ( p  = 0.025) and well-being ( p  = 0.008).
","[{'ForeName': 'Débora Cristiane da Silva', 'Initials': 'DCDS', 'LastName': 'Andrade', 'Affiliation': 'Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Mateus Andrea', 'Initials': 'MA', 'LastName': 'Angelucci', 'Affiliation': 'Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Edson Zangiacomi', 'Initials': 'EZ', 'LastName': 'Martinez', 'Affiliation': 'Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Ana Maria Soares', 'Initials': 'AMS', 'LastName': 'Pereira', 'Affiliation': 'Department of Plant Biotechnology, University of Ribeirão Preto (UNAERP), Ribeirão Preto, Brazil.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0038-1676326']
3224,30855411,Suture Removal After Trabeculectomy With Fornix-based Conjunctival Flap Leads to Faster Visual Recovery but Not Reduced Astigmatism.,"PRéCIS:: The closing limbal suture after trabeculectomy with a fornix-based conjunctival flap plays no critical role in the development of corneal astigmatism and intraocular pressure (IOP). A standard removal is not recommended.
PURPOSE


To investigate the effect of removal of the conjunctival suture after trabeculectomy with fornix-based conjunctival flap on corneal astigmatism, visual acuity, and IOP.
METHODS


Eighty-seven cases of trabeculectomy with mitomycin C with a fornix-based conjunctival flap performed in the eyes of 82 patients (5 patients underwent bilateral trabeculectomy) were enrolled in a prospective randomized study. All surgeries were conducted by the same surgeon (J.W.) in the Ophthalmology Department of the University Medical Center of Mainz, Germany. All eyes received a corneal-conjunctival, continuous, mattress, interlocked suture for closing the conjunctiva at the limbus. After randomization, in 46 cases the suture was removed 6 weeks postoperatively; in 41 patients, the suture was left in place. All patients were examined preoperatively, and at 6 weeks, 3 months, 6 months, and 12 months after surgery. Astigmatism was measured using objective refraction and corneal topography, IOP and visual acuity were also assessed. Results were compared using a Wilcoxon test or Mann-Whitney U test for single time-points.
RESULTS


During follow-up, no significant differences between the 2 study groups regarding refractive or topographic values were found. Patients in the suture removal group had a significantly higher visual acuity than controls at 3 months, 6 months, and 1 year after surgery. IOP was similar in both groups throughout the study.
CONCLUSIONS


Removal of the conjunctival suture in trabeculectomy with a fornix-based conjunctival flap leads to a faster rehabilitation of visual acuity but does not significantly affect corneal astigmatism or IOP.",2019,"Patients in the suture removal group had a significantly higher visual acuity than controls at 3 months, 6 months, and 1 year after surgery.","['82 patients (5 patients underwent', 'Eighty-seven cases of', 'All surgeries were conducted by the same surgeon (J.W.) in the Ophthalmology Department of the University Medical Center of Mainz, Germany']","['limbal suture after trabeculectomy with a fornix-based conjunctival flap', 'corneal-conjunctival, continuous, mattress, interlocked suture for closing the conjunctiva at the limbus', 'trabeculectomy with mitomycin C with a fornix-based conjunctival flap', 'Trabeculectomy With Fornix-based Conjunctival Flap', 'conjunctival suture after trabeculectomy with fornix-based conjunctival flap', 'bilateral trabeculectomy', 'Suture Removal']","['visual acuity', 'IOP', 'corneal astigmatism, visual acuity, and IOP', 'Faster Visual Recovery', 'objective refraction and corneal topography, IOP and visual acuity', 'refractive or topographic values', 'corneal astigmatism and intraocular pressure (IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0587524', 'cui_str': 'Ophthalmology department (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0009758', 'cui_str': 'Conjunctival structure (body structure)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0184936', 'cui_str': 'Removal of suture (procedure)'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1301317', 'cui_str': 'Objective refraction'}, {'cui': 'C0524957', 'cui_str': 'Corneal Topography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",87.0,0.122814,"Patients in the suture removal group had a significantly higher visual acuity than controls at 3 months, 6 months, and 1 year after surgery.","[{'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Laspas', 'Affiliation': 'Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Leichsenring', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Preussner', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wahl', 'Affiliation': ''}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pfeiffer', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001232']
3225,30898550,"Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial.","BACKGROUND


Iron from haemolysed blood is implicated in secondary injury after intracerebral haemorrhage. We aimed to assess the safety of the iron chelator deferoxamine mesylate in patients with intracerebral haemorrhage and to establish whether the drug merits investigation in a phase 3 trial.
METHODS


We did a multicentre, futility-design, randomised, placebo-controlled, double-blind, phase 2 trial at 40 hospitals in Canada and the USA. Adults aged 18-80 years with primary, spontaneous, supratentorial intracerebral haemorrhage were randomly assigned (1:1) to receive deferoxamine mesylate (32 mg/kg per day) or placebo (saline) infusions for 3 consecutive days within 24 h of haemorrhage onset. Randomisation was done via a web-based trial-management system centrally in real time, and treatment allocation was concealed from both participants and investigators. The primary outcome was good clinical outcome, which was defined as a modified Rankin Scale score of 0-2 at day 90. We did a futility analysis: if the 90% upper confidence bound of the absolute risk difference between the two groups in the proportion of participants with a good clinical outcome was less than 12% in favour of deferoxamine mesylate, then to move to a phase 3 efficacy trial would be futile. Primary outcome and safety data were analysed in the modified intention-to-treat population, comprising only participants in whom the study infusions were initiated. This trial is registered with ClinicalTrials.gov, number NCT02175225, and is completed.
FINDINGS


We recruited 294 participants between Nov 23, 2014, and Nov 10, 2017. The modified intention-to-treat population consisted of 144 patients assigned to the deferoxamine mesylate group and 147 assigned to the placebo group. At day 90, among patients with available data for the primary outcome, 48 (34%) of 140 participants in the deferoxamine mesylate group, and 47 (33%) of 143 patients in the placebo group, had modified Rankin Scale scores of 0-2 (adjusted absolute risk difference 0·6% [90% upper confidence bound 6·8%]). By day 90, 70 serious adverse events were reported in 39 (27%) of 144 patients in the deferoxamine mesylate group, and 78 serious adverse events were reported in 49 (33%) of 147 patients in the placebo group. Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died. None of the deaths were judged to be treatment related.
INTERPRETATION


Deferoxamine mesylate was safe. However, the primary result showed that further study of the efficacy of deferoxamine mesylate with anticipation that the drug would significantly improve the chance of good clinical outcome (ie, mRS score of 0-2) at day 90 would be futile.
FUNDING


US National Institutes of Health and US National Institute of Neurological Disorders and Stroke.",2019,Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died.,"['We recruited 294 participants between Nov 23, 2014, and Nov 10, 2017', 'patients with intracerebral haemorrhage', 'Adults aged 18-80 years with primary, spontaneous, supratentorial intracerebral haemorrhage', 'patients with intracerebral haemorrhage (i-DEF', '40 hospitals in Canada and the USA', '144 patients assigned to the']","['Deferoxamine mesylate', 'placebo (saline) infusions', 'placebo', 'iron chelator deferoxamine mesylate', 'deferoxamine mesylate']","['serious adverse events', 'modified Rankin Scale scores', 'modified Rankin Scale score', 'safety data']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0011148', 'cui_str': 'deferoxamine mesylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007974', 'cui_str': 'Complexons'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",294.0,0.668382,Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died.,"[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Selim', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: mselim@bidmc.harvard.edu.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Xi', 'Affiliation': 'Department of Neurosurgery, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Health Science Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Neurology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Greenberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'James', 'Affiliation': 'Department of Anesthesiology and Neurology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Vineeta', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Clark', 'Affiliation': 'Oregon Health and Science University Hospital, Portland, OR, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30069-9']
3226,30817329,"Insights Into a ""Negative"" ICU Trial Derived From Gene Expression Profiling.","OBJECTIVES


Randomized controlled trials in the ICU often fail to show differences in endpoints between groups. We sought to explore reasons for this at a molecular level by analyzing transcriptomic data from a recent negative trial. Our objectives were to determine if randomization successfully balanced transcriptomic features between groups, to assess transcriptomic heterogeneity among the study subjects included, and to determine if the study drug had any effect at the gene expression level.
DESIGN


Bioinformatics analysis of transcriptomic and clinical data collected in the course of a randomized controlled trial.
SETTING


Tertiary academic mixed medical-surgical ICU.
PATIENTS


Adult, critically ill patients expected to require invasive mechanical ventilation more than 48 hours.
INTERVENTIONS


Lactoferrin or placebo delivered enterally and via an oral swab for up to 28 days.
MEASUREMENTS AND MAIN RESULTS


We found no major imbalances in transcriptomic features between groups. Unsupervised analysis did not reveal distinct clusters among patients at the time of enrollment. There were marked differences in gene expression between early and later time points. Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
CONCLUSIONS


In this clinical trial, transcriptomic data provided a useful complement to clinical data, suggesting that the reasons for the negative result were less likely related to the biological efficacy of the study drug, and may instead have been related to poor sensitivity of the clinical outcomes. In larger studies, transcriptomics may also prove useful in predicting response to treatment.",2019,"Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
","['Adult, critically ill patients expected to require invasive mechanical ventilation more than 48 hours', 'Tertiary academic mixed medical-surgical ICU']","['Lactoferrin or placebo', 'lactoferrin']","['gene expression', 'transcriptomic features']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.255209,"Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hoekstra', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maslove', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Veldhoen', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Critical Illness and Injury Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}]",Critical care medicine,['10.1097/CCM.0000000000003693']
3227,31322567,24S-Hydroxycholesterol Is Associated with Agitation Severity in Patients with Moderate-to-Severe Alzheimer's Disease: Analyses from a Clinical Trial with Nabilone.,"BACKGROUND


Agitation is a prevalent and difficult-to-treat symptom of Alzheimer's disease (AD). The endocannabinoid system (ECS) has been a target of interest for the treatment of agitation. However, ECS signaling may interact with AD-related changes in brain cholesterol metabolism. Elevated brain cholesterol, reflected by reduced serum 24-S-hydroxycholesterol (24S-OHC), is associated with reduced membrane fluidity, preventing ligand binding to cannabinoid receptor 1.
OBJECTIVE


To assess whether 24S-OHC was associated with agitation severity and response to nabilone.
METHODS


24S-OHC was collected from AD patients enrolled in a clinical trial on nabilone at the start and end of each phase. This allowed for the cross-sectional and longitudinal investigation between 24S-OHC and agitation (Cohen Mansfield Agitation Inventory, CMAI). Post-hoc analyses included adjustments for baseline standardized Mini-Mental Status Exam (sMMSE), and analyses with CMAI subtotals consistent with the International Psychogeriatric Association (IPA) definition for agitation (physical aggression and nonaggression, and verbal aggression).
RESULTS


24S-OHC was not associated with CMAI scores cross-sectionally or longitudinally, before and after adjusting for baseline sMMSE. However, 24S-OHC was associated with greater CMAI IPA scores at baseline (F(1,36) = 4.95, p = 0.03). In the placebo phase only, lower 24S-OHC at baseline was associated with increases in CMAI IPA scores (b = -35.2, 95% CI -65.6 to -5.0, p = 0.02), and decreases in 24S-OHC were associated with increases in CMAI IPA scores (b = -20.94, 95% CI -57.9 to -4.01, p = 0.03).
CONCLUSION


24S-OHC was associated with agitation severity cross-sectionally, and longitudinally in patients with AD. However, 24S-OHC did not predict treatment response, and does not change over time with nabilone.",2019,"Elevated brain cholesterol, reflected by reduced serum 24-S-hydroxycholesterol (24S-OHC), is associated with reduced membrane fluidity, preventing ligand binding to cannabinoid receptor 1.
","[""Patients with Moderate-to-Severe Alzheimer's Disease"", '24S-OHC was collected from AD patients enrolled in a clinical trial on nabilone at the start and end of each phase']","['24S-OHC', 'endocannabinoid system (ECS']","['Elevated brain cholesterol', '24S-OHC', 'lower 24S-OHC', 'CMAI IPA scores', 'baseline standardized Mini-Mental Status Exam (sMMSE), and analyses with CMAI subtotals consistent with the International Psychogeriatric Association (IPA) definition for agitation (physical aggression and nonaggression, and verbal aggression', 'brain cholesterol metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0017467', 'cui_str': 'Psychogeriatrics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}, {'cui': 'C0424322', 'cui_str': 'Verbal aggression (finding)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",,0.214571,"Elevated brain cholesterol, reflected by reduced serum 24-S-hydroxycholesterol (24S-OHC), is associated with reduced membrane fluidity, preventing ligand binding to cannabinoid receptor 1.
","[{'ForeName': 'Myuri', 'Initials': 'M', 'LastName': 'Ruthirakuhan', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Andreazza', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicolaas Paul L G', 'Initials': 'NPLG', 'LastName': 'Verhoeff', 'Affiliation': 'Department of Psychiatry, Baycrest Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190202']
3228,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3229,31471037,Human Extinction Learning Is Accelerated by an Angiotensin Antagonist via Ventromedial Prefrontal Cortex and Its Connections With Basolateral Amygdala.,"BACKGROUND


Deficient extinction learning and threat adaptation in the ventromedial prefrontal cortex (vmPFC)-amygdala circuitry strongly impede the efficacy of exposure-based interventions in anxiety disorders. Recent animal models suggest a regulatory role of the renin-angiotensin system in both these processes. Against this background, the present randomized placebo-controlled pharmacologic functional magnetic resonance imaging experiment aimed at determining the extinction enhancing potential of the angiotensin II type 1 receptor antagonist losartan (LT) in humans.
METHODS


Seventy healthy male subjects underwent Pavlovian threat conditioning and received single-dose LT (50 mg) or placebo administration before extinction. Psychophysiological threat reactivity (skin conductance response) and neural activity during extinction served as primary outcomes. Psychophysiological interaction, voxelwise mediation, and novel multivariate pattern classification analyses were used to determine the underlying neural mechanisms.
RESULTS


LT significantly accelerated the decline of the psychophysiological threat response during within-session extinction learning. On the neural level, the acceleration was accompanied and critically mediated by threat-specific enhancement of vmPFC activation. Furthermore, LT enhanced vmPFC-basolateral amygdala coupling and attenuated the neural threat expression, particularly in the vmPFC, during early extinction.
CONCLUSIONS


Overall the results indicate that LT facilitates within-session threat memory extinction by augmenting threat-specific encoding in the vmPFC and its regulatory control over the amygdala. The findings document a pivotal role of angiotensin regulation of extinction learning in humans and suggest that adjunct LT administration has the potential to facilitate the efficacy of exposure-based interventions in anxiety disorders.",2019,"Furthermore, LT enhanced vmPFC-basolateral amygdala coupling and attenuated the neural threat expression, particularly in the vmPFC, during early extinction.
","['humans', 'Seventy healthy male subjects underwent']","['placebo', 'Pavlovian threat conditioning and received single-dose LT']","['Psychophysiological threat reactivity (skin conductance response) and neural activity', 'psychophysiological threat response']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",70.0,0.0299002,"Furthermore, LT enhanced vmPFC-basolateral amygdala coupling and attenuated the neural threat expression, particularly in the vmPFC, during early extinction.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yayuan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Feng', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China; Key Laboratory of Cognition and Personality, Ministry of Education, Southwest University, Chongqing, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Tingyong', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China; Key Laboratory of Cognition and Personality, Ministry of Education, Southwest University, Chongqing, China.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Guastella', 'Affiliation': 'Autism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, Australia; Youth Mental Health Unit, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Ebstein', 'Affiliation': 'China Center for Behavior Economics and Finance, Southwestern University of Finance and Economics, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Clinical Hospital of Chengdu Brain Science Institute and Ministry of Education (MOE) Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: ben_becker@gmx.de.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.07.007']
3230,30796054,Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial.,"PURPOSE


Clinically evaluate intraocular pressure (IOP) measurements taken with a Goldmann applanation tonometer (GAT) prism and a modified surface Goldmann prism examining measurement differences correlated to central corneal thickness (CCT) and corneal hysteresis (CH) values.
DESIGN


Prospective, open-label, randomised, controlled, multicentre reference device accuracy analysis.
METHODS


A GAT and a modified surface GAT prism measured IOP on 243 unique eyes. The study design and methodology complied with International Standard Organization (ISO) tonometer evaluation guidelines, except the inclusion of thin (<500 µm) and thick (>600 µm) corneas. All eyes were randomised to IOP measurement by one of five standard Goldmann prisms and five modified prisms. Pressures were measured by six investigators, two times with each prism for a total of 1936 IOP measurements. Analysis included a multiple linear regression including CCT and CH correlation.
RESULTS


The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007). Corneal hysteresis (CH) also significantly correlated to the difference in prism measurements (R 2 =0.125, p=0.039). There was no significant overall mean IOP bias between the two prisms (+0.43 mm Hg in modified, p=0.19).
DISCUSSION


The paired IOP measurement difference between GAT and a modified surface Goldmann replacement prism indicated a statistically significant correlation to CCT and CH. A simple modified replacement prism for any Goldmann-type tonometer may significantly improve IOP measurement accuracy by minimising corneal biomechanical errors associated with CCT and CH.
TRIAL REGISTRATION NUMBER


NCT02990169 and NCT02989909.",2019,"The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007).",['243 unique eyes'],"['modified surface GAT prism measured IOP', 'Goldmann applanation tonometer (GAT) prism']","['central corneal thickness (CCT) and corneal hysteresis (CH) values', 'corneal biomechanical metrics', 'intraocular pressure (IOP) measurements', 'Corneal hysteresis (CH', 'overall mean IOP bias', 'IOP measurement accuracy', 'IOP measurements']","[{'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0124604', 'cui_str': 'Miraa'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",1936.0,0.146695,"The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007).","[{'ForeName': 'Sean Joseph', 'Initials': 'SJ', 'LastName': 'McCafferty', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA sjmccafferty66@hotmail.com.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Tetrault', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McColgin', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Chue', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Muller', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313470']
3231,31146022,The Trials within Cohorts design faced methodological advantages and disadvantages in the exercise oncology setting.,"OBJECTIVES


The Trials within Cohorts (TwiCs) design is an alternative for pragmatic randomized controlled trials (RCTs) and might overcome disadvantages such as difficult recruitment, dropout after randomization to control, and contamination. We investigated the applicability of the TwiCs design in an exercise oncology study regarding the recruitment process, representativeness of the study sample, contamination, participation, and dropout.
METHODS


The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA) Fit TwiCs evaluates an exercise intervention in inactive breast cancer patients. Eligible patients participating in the prospective UMBRELLA were identified and randomized. Patients randomized to the intervention (n = 130) were offered the intervention, whereas controls (n = 130) were not informed.
RESULTS


Fifty-two percent (n = 68) accepted the intervention. Because this rate was lower than expected, a larger sample size was required than initially estimated (n = 166). However, recruitment of 260 patients was still completed by one researcher within 30 months. Unselective eligibility screening and randomization before invitation improved representativeness. Disadvantage of the design might be inclusion of ineligible patients when cohort information is limited. Furthermore, the design faced higher noncompliance in the intervention group, but prevention of contamination.
CONCLUSION


The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.",2019,"The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.","['260 patients was still completed by one researcher within 30\xa0months', 'Eligible patients participating in the prospective', 'inactive breast cancer patients']",['exercise intervention'],[],"[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],260.0,0.0542404,"The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.","[{'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Carla H', 'Initials': 'CH', 'LastName': 'van Gils', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rolf H H', 'Initials': 'RHH', 'LastName': 'Groenwold', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Desirée H J G', 'Initials': 'DHJG', 'LastName': 'van den Bongard', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: A.M.May@umcutrecht.nl.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.017']
3232,31753900,"Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes.","INTRODUCTION


Recommendations on energy intake are key in body weight management to improve glycaemic control in people with type 2 diabetes (T2D). International clinical guidelines recommend a variety of eating patterns to promote energy restriction as the primary dietetic approach to body weight control in managing T2D. In addition, individualised guidance on self-monitoring carbohydrate intake to optimise meal timing and food choices (eg, basic carbohydrate counting (BCC)) is recommended to achieve glycaemic control. However, the evidence for this approach in T2D is limited. The objective of this study was to compare the effect of an educational programme in BCC as add-on to the usual dietary care on glycaemic control in people with T2D.
METHODS AND ANALYSES


The study is designed as a randomised, controlled trial with a parallel-group design. The study duration is 12 months with data collection at baseline, and after 6 and 12 months. We plan to include 226 adults with T2D. Participants will be randomised to one of two interventions: (1) BCC as add-on to usual dietary care or (2) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups. Further outcome measures include changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.
ETHICS AND DISSEMINATION


The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03623139.",2019,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups.,"['people with type 2 diabetes (T2D', 'patients with type 2 diabetes', '226 adults with T2D. Participants', 'people with T2D']","['optimise meal timing and food choices (eg, basic carbohydrate counting (BCC', 'basic carbohydrate counting versus standard outpatient nutritional education', 'educational programme', 'BCC as add-on to usual dietary care or (2) usual dietary care']","['glycated haemoglobin A1c or mean amplitude of glycaemic excursions', 'changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034380'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",226.0,0.0908177,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Ewers', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark bettina.ewers@regionh.dk.'}, {'ForeName': 'Jens Meldgaard', 'Initials': 'JM', 'LastName': 'Bruun', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus, Denmark, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-032893']
3233,31143952,Time-to-isolation-guided cryoballoon ablation reduces oesophageal and mediastinal alterations detected by endoscopic ultrasound: results of the MADE-PVI trial.,"AIMS


Cryoballoon ablation is safe and efficient for achieving pulmonary vein isolation (PVI) in atrial fibrillation. Structural oesophago-mediastinal lesions, which seem to be associated with an increased risk of the lethal complication of an atrio-oesophageal fistula, have been described. MADE-PVI (Mediastino-oesophageal Alterations Detected by Endosonography after PVI) aimed at evaluating safety of cryoballoon PVI in relation to two different freeze protocols. As time-to-isolation-(TTI)-guided protocol has been reported to be as effective as conventional 'two freeze protocol', we hypothesized a TTI-guided protocol causes less oesophago-mediastinal lesions.
METHODS AND RESULTS


Seventy consecutive patients were scheduled for cryoballoon (2nd generation) PVI employing either a conventional protocol (n = 35: 2 × 180 s per vein) or a TTI-guided approach (n = 35: TTI + 120 s per vein or 1 × 180 s in case TTI could not be measured). Oesophagogastroduodenoscopy and endoscopic ultrasound, assessing oesophago-mediastinal alterations (e.g. ulceration, oedema) were performed blinded prior and post-ablation. Post-interventional mediastinal oedematous alterations were detected in 70% with a mean diameter of 14 mm (±0.9 mm), while only 15% revealed large mediastinal oedema >20 mm. Oesophageal lesions due to PVI occurred in 5%. Freeze protocols had a distinct impact on oesophago-mediastinal alterations as mean diameter and frequency of large oedema were significantly increased in patients after conventional protocol PVI (17 mm vs. 11 mm; 26% vs. 6%). Furthermore, every oesophageal lesion was detected in patients with conventional protocol (9%). No major complication occurred in either group.
CONCLUSION


The present prospective study demonstrates a significant impact of freeze protocol on oesophago-mediastinal alterations. A TTI-guided protocol reduces mediastino-oesophageal lesions and may reduce short- and long-term complications of cryoballoon PVI.",2019,Freeze protocols had a distinct impact on oesophago-mediastinal alterations as mean diameter and frequency of large oedema were significantly increased in patients after conventional protocol PVI (17 mm vs. 11 mm; 26% vs. 6%).,['Seventy consecutive patients were scheduled for cryoballoon (2nd generation'],"['freeze protocol', 'Cryoballoon ablation', 'conventional protocol (n\u2009=\u200935: 2 × 180 s per vein) or a TTI-guided approach (n\u2009=\u200935: TTI\u2009+\u2009120 s per vein or 1 × 180 s in case TTI', 'Time-to-isolation-guided cryoballoon ablation']","['major complication', 'Oesophageal lesions due to PVI', 'oesophago-mediastinal alterations as mean diameter and frequency of large oedema', 'large mediastinal oedema']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}]",70.0,0.0501929,Freeze protocols had a distinct impact on oesophago-mediastinal alterations as mean diameter and frequency of large oedema were significantly increased in patients after conventional protocol PVI (17 mm vs. 11 mm; 26% vs. 6%).,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Cordes', 'Affiliation': 'Department of Medicine B, Gastroenterology and Hepatology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ellermann', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Dechering', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Frommeyer', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kochhäuser', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Philipp S', 'Initials': 'PS', 'LastName': 'Lange', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lenze', 'Affiliation': 'Department of Medicine B, Gastroenterology and Hepatology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine B, Gastroenterology and Hepatology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Hansjoerg', 'Initials': 'H', 'LastName': 'Ullerich', 'Affiliation': 'Department of Medicine B, Gastroenterology and Hepatology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': 'Department of Cardiology II - Electrophysiology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz142']
3234,31153882,Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial.,"BACKGROUND


The survival benefit of early placement of transjugular intrahepatic portosystemic shunts (TIPS) in patients with cirrhosis and acute variceal bleeding is controversial. We aimed to assess whether early TIPS improves survival in patients with advanced cirrhosis and acute variceal bleeding.
METHODS


We did an investigator-initiated, open-label, randomised controlled trial at an academic hospital in China. Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomly assigned (2:1) to receive either early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation for the prevention of rebleeding, with TIPS as rescue therapy when needed [control group]). Randomisation was done by web-based randomisation system using a Pocock and Simon's minimisation method with Child-Pugh class (B vs C) and presence or absence of active bleeding as adjustment factors. The primary outcome was transplantation-free survival, analysed in the intention-to-treat population, excluding individuals subsequently found to be ineligible for enrolment. This study is registered with ClinicalTrials.gov, number NCT01370161, and is completed.
FINDINGS


From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients were randomly assigned to the early TIPS group (n=86) or to the control group (n=46). After exclusion of three individuals subsequently found to be ineligible for enrolment (two patients in the early TIPS group with non-cirrhotic portal hypertension or hepatocellular carcinoma, and one patient in the control group due to non-cirrhotic portal hypertension), 84 patients in the early TIPS group and 45 patients in the control group were included in the intention-to-treat population. 15 (18%) patients in the early TIPS group and 15 (33%) in the control group died; two (2%) patients in the early TIPS group and one (2%) in the control group underwent liver transplantation. Transplantation-free survival was higher in the early TIPS group than in the control group (hazard ratio 0·50, 95% CI 0·25-0·98; p=0·04). Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046). There were no significant differences between the two groups in the incidence of hepatic hydrothorax (two [2%] of 84 patients in the early TIPS group vs one [2%] of 45 in the control group; p=0·96), spontaneous bacterial peritonitis (one [1%] vs three [7%]; p=0·12), hepatic encephalopathy (29 [35%] vs 16 [36%]; p=1·00), hepatorenal syndrome (four [5%] vs six [13%]; p=0·10), and hepatocellular carcinoma (four [5%] vs one [2%]; p=0·68). There was no significant difference in the number of patients who experienced other serious adverse events (ten [12%] vs 11 [24%]; p=0·07) or non-serious adverse events (21 [25%] vs 19 [42%]; p=0·05) between groups.
INTERPRETATION


Early TIPS with covered stents improved transplantation-free survival in selected patients with advanced cirrhosis and acute variceal bleeding and should therefore be preferred to the current standard of care.
FUNDING


National Natural Science Foundation of China, National Key Technology R&D Program, Optimized Overall Project of Shaanxi Province, Boost Program of Xijing Hospital.",2019,Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046).,"['patients with cirrhosis and acute variceal bleeding', 'academic hospital in China', 'patients with advanced cirrhosis', 'patients with advanced cirrhosis and acute variceal bleeding', 'Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy', 'selected patients with advanced cirrhosis and acute variceal bleeding', 'From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients']","['early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation', 'transjugular intrahepatic portosystemic shunts (TIPS', 'Early TIPS with covered stents versus standard treatment', 'early TIPS']","['survival', 'hepatic encephalopathy', 'hepatocellular carcinoma', 'serious adverse events', 'non-serious adverse events', 'transplantation-free survival', 'Transplantation-free survival', 'spontaneous bacterial peritonitis', 'hepatorenal syndrome', 'incidence of hepatic hydrothorax']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1263666', 'cui_str': 'Advanced cirrhosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0275551', 'cui_str': 'Primary bacterial peritonitis (disorder)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1963739', 'cui_str': 'Hepatic hydrothorax'}]",373.0,0.229334,Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046).,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Chuangye', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xulong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Huahong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ultrasound, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Ultrasound, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Enxin', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China; Department of Technology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhanxin', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. Electronic address: hangh@fmmu.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30090-1']
3235,31615643,"Complexity, symmetry and variability of forward and backward walking at different speeds and transfer effects on forward walking: Implications for neural control.","This study aimed to investigate effects of walking direction and speed on gait complexity, symmetry and variability as indicators of neural control mechanisms, and if a period of backward walking has acute effects on forward walking. Twenty-two young adults attended 2 visits. In each visit participants walked forwards at preferred walking speed (PWS) for 3-minutes (pre) followed by 5-minutes walking each at 80%, 100% and 120% of PWS of either forward or backward walking then a further 3-minutes walking forward at PWS (post). The order of walking speed in each visit was randomised and walking direction of each visit was randomised. An inertial measurement unit was placed over L5 vertebra to record tri-axial accelerations. From the trunk accelerations multiscale entropy, harmonic ratio and stride time variability were calculated to measure complexity, symmetry and variability for each walk. Complexity increased with increasing walking speed for all axes in forward and backward walking, and backward walking was less complex than forward walking. Stride time variability was also greater in backward than forward walking. Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects. No effects were found for harmonic ratio. These results suggest during backward walking trunk motion is rigidly controlled but central pattern generators responsible for temporal gait patterns are less refined for backward walking. However, in both directions complexity increased as speed increased suggesting additional constraint of trunk motion, normally characterised by reduced complexity, is not applied as speed increases.",2019,Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects.,['Twenty-two young adults attended 2 visits'],['walking direction and speed'],"['harmonic ratio and stride time variability', 'Stride time variability', 'Anterio-posterior and medio-lateral complexity', 'Complexity, symmetry and variability of forward and backward walking', 'harmonic ratio']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}]",22.0,0.0272654,Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects.,"[{'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Walsh', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford OX23 0BP, UK. Electronic address: gwalsh@brookes.ac.uk.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Taylor', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford OX23 0BP, UK.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109377']
3236,30194618,Comparison of sonohysterography to hysterosalpingogram for tubal patency assessment in a multicenter fertility treatment trial among women with polycystic ovary syndrome.,"PURPOSE


To compare saline infusion sonohysterography (SIS) versus hysterosalpingogram (HSG) for confirmation of tubal patency.
METHODS


Secondary analysis of a randomized controlled trial, Pregnancy in Polycystic Ovary Syndrome II (PPCOS II). Seven hundred fifty infertile women (18-40 years old) with polycystic ovary syndrome (PCOS) were randomized to up to 5 cycles of letrozole or clomiphene citrate. Prior to enrollment, tubal patency was determined by HSG, the presence of free fluid in the pelvis on SIS, laparoscopy, or recent intrauterine pregnancy. Logistic regression was conducted in patients who ovulated with clinical pregnancy as the outcome and HSG or SIS as the key independent variable.
RESULTS


Among women who ovulated, 414 (66.9%) had tubal patency confirmed by SIS and 187 (30.2%) had at least one tube patent on HSG. Multivariable analysis indicated that choice of HSG versus SIS did not have a significant relationship on likelihood of clinical pregnancy, after adjustment for treatment arm, BMI, duration of infertility, smoking, and education (OR 1.14, 95% CI 0.77, 1.67, P = 0.52). Ectopic pregnancy occurred more often in women who had tubal patency confirmed by HSG compared to SIS (2.8% versus 0.6%, P = 0.02).
CONCLUSIONS


In this large cohort of women with PCOS, there was no significant difference in clinical pregnancy rate between women who had tubal patency confirmed by HSG versus SIS. SIS is an acceptable imaging modality for assessment of tubal patency in this population.",2018,"Ectopic pregnancy occurred more often in women who had tubal patency confirmed by HSG compared to SIS (2.8% versus 0.6%, P = 0.02).
","['women with polycystic ovary syndrome', 'Seven hundred fifty infertile women (18-40\xa0years old) with polycystic ovary syndrome (PCOS', 'Polycystic Ovary Syndrome II (PPCOS II']","['letrozole or clomiphene citrate', 'saline infusion sonohysterography (SIS) versus hysterosalpingogram (HSG', 'HSG', 'sonohysterography to hysterosalpingogram']","['Ectopic pregnancy', 'tubal patency', 'clinical pregnancy rate', 'BMI, duration of infertility, smoking, and education', 'likelihood of clinical pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0949051', 'cui_str': 'Saline infusion sonohysterography'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",750.0,0.187516,"Ectopic pregnancy occurred more often in women who had tubal patency confirmed by HSG compared to SIS (2.8% versus 0.6%, P = 0.02).
","[{'ForeName': 'Mindy S', 'Initials': 'MS', 'LastName': 'Christianson', 'Affiliation': 'Department of Gynecology and Obstetrics, Division of Reproductive Endocrinology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. mchris21@jhmi.edu.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Ob/Gyn, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA, USA.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Vitek', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Styer', 'Affiliation': 'Department of Obstetrics, Gynecologyn, and Reproductive Biology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, Shands Hospital, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Puscheck', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Alicia Y', 'Initials': 'AY', 'LastName': 'Christy', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Polotsky', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-018-1306-2']
3237,31738173,Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial.,"BACKGROUND


Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist.
OBJECTIVE


The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms.
METHODS


Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation.
RESULTS


Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; P<.001), with a moderate treatment effect size (d=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55).
CONCLUSIONS


These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878.",2019,"Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55).","['rural community population of adults with depression symptoms', '343 adults with depression symptoms', 'Adults With Depression Symptoms']","['Fully Automated Internet-Based Cognitive Behavior Therapy Intervention', 'iCBT intervention', 'internet-based cognitive behavior therapy (iCBT) interventions']","['anxiety symptoms', 'depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation', 'depression and anxiety symptom severity', 'suicidal ideation', 'work/social functioning', 'depression symptom severity']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C0683253', 'cui_str': 'Psychological Resiliences'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",343.0,0.123356,"Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55).","[{'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Schure', 'Affiliation': 'Department of Health & Human Development, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Greist', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nakonezny', 'Affiliation': 'Department of Population and Data Science, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Health & Human Development, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Bryan', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Byerly', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}]",Journal of medical Internet research,['10.2196/14754']
3238,31253071,Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising.,"Prescription drug broadcast advertisements in the United States are required to present the product's major risks in at least the audio portion of the ad (21 CFR 202.1(e)(1)). This can result in a lengthy list of risks and side effects. The U.S. Food and Drug Administration has been studying the effects of limiting the major statement to those risks that are serious and actionable. We explore the level of agreement between consumers and experts regarding what risks and side effects are serious and actionable, and how variations in the content of major risk statement as well as other factors such as demographic variables, perceived accuracy of direct-to-consumer advertising, illness knowledge, and knowledge of prescription drug regulations, predict perceptions of risk and actionability. Participants (N = 1,000) self-diagnosed with depression or insomnia were randomly assigned to view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks. Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability. Results also varied as a function of income and gender.",2019,"Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability.","['Participants (N\xa0', '1,000) self-diagnosed with depression or insomnia']",['view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks'],[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],,0.0168382,"Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability.","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a US Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , Maryland , USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Boudewyns', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'a US Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , Maryland , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1632396']
3239,30724002,"The effects of licogliflozin, a dual SGLT1/2 inhibitor, on body weight in obese patients with or without diabetes.","BACKGROUND


There is an unmet need for a safer and more effective treatment for obesity. This study assessed the effects of licogliflozin, a dual inhibitor of sodium-glucose co-transporter (SGLT) 1/2, on body weight, metabolic parameters and incretin hormones in patients with type 2 diabetes mellitus (T2DM) and/or obesity.
METHODS


Patients with obesity (BMI, 35-50 kg/m 2  ) were enrolled into a 12-week study (N = 88; licogliflozin 150 mg q.d.). Patients with T2DM were enrolled into a second, two-part study, comprising a single-dose cross-over study (N = 12; 2.5 - 300 mg) and a 14-day dosing study (N = 30; 15 mg q.d). Primary endpoints included effects on body weight, effects on glucose, safety and tolerability. Secondary endpoints included urinary glucose excretion (UGE 24  ) and pharmacokinetics, while exploratory endpoints assessed the effects on incretin hormones (total GLP-1, PYY 3-36  , and GIP), insulin and glucagon.
RESULTS


Treatment with licogliflozin 150 mg q.d. for 12 weeks in patients with obesity significantly reduced body weight by 5.7% vs placebo (P < 0.001) and improved metabolic parameters such as significantly reduced postprandial glucose excursion (21%; P < 0.001), reduced insulin levels (80%; P < 0.001) and increased glucagon (59%; P < 0.001). In patients with T2DM, a single dose of licogliflozin 300 mg in the morning prior to an oral glucose tolerance test (OGTT) remarkably reduced glucose excursion by 93% (P < 0.001; incremental AUC 0-4h  ) and suppressed insulin by 90% (P < 0.01; incremental AUC 0-4h  ). Treatment with licogliflozin 15 mg q.d. for 14 days reduced 24-hour average glucose levels by 26% (41 mg/dL; P < 0.001) and increased UGE 24  to 100 g (P < 0.001) in patients with T2DM. In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001). Treatment with licogliflozin was generally safe and well tolerated. Diarrhea (increased numbers of loose stool) was the most common adverse event in all studies (90% with licogliflozin vs 25% with placebo in the 12-week study), while a lower incidence of flatulence, abdominal pain and abdominal distension (25%-43% with licogliflozin vs 9%-11% with placebo in the 12-week study) were among the other gastrointestinal events reported.
CONCLUSION


Licogliflozin treatment (1-84 days) leads to significant weight loss and favourable changes in a variety of metabolic parameters and incretin hormones. Dual inhibition of SGLT1/2 with licogliflozin in the gut and kidneys is an attractive strategy for treating obesity and diabetes.",2019,"In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001).","['patients with type 2 diabetes mellitus (T2DM) and/or obesity', 'Patients with obesity (BMI, 35-50\u2009kg/m 2  ', 'Patients with T2DM', 'obese patients with or without diabetes']","['placebo', 'SGLT1/2 with licogliflozin', 'licogliflozin, a dual inhibitor of sodium-glucose co-transporter (SGLT', 'licogliflozin', 'Licogliflozin']","['total GLP-1', 'safe and well tolerated', 'urinary glucose excretion (UGE 24  ) and pharmacokinetics, while exploratory endpoints assessed the effects on incretin hormones (total GLP-1, PYY 3-36  , and GIP), insulin and glucagon', 'postprandial glucose excursion', 'reduced insulin levels', 'GIP levels', 'Diarrhea', 'weight loss', '24-hour average glucose levels', 'flatulence, abdominal pain and abdominal distension', 'body weight, metabolic parameters and incretin hormones', 'body weight, effects on glucose, safety and tolerability', 'glucose excursion', 'glucagon', 'body weight', 'metabolic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0312349,"In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001).","[{'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'He', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haynes', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Meyers', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Amer', 'Affiliation': 'CMO and Patient Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Early Development Biostatistics, Biostatistics and Pharmacometrics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Mahling', 'Affiliation': 'DEV B&SS, CM/Global Health, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Anisha E', 'Initials': 'AE', 'LastName': 'Mendonza', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chutkow', 'Affiliation': 'Cardiovascular and Metabolism Disease Area, Novartis Institutes for BioMedical Research, Cambridge, Massachussets.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bachman', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13654']
3240,31760820,Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi.,"BACKGROUND


Circumferential pulmonary vein isolation (CPVI) often cause unavoidable vagal reflexes during procedure due to the coincidental modification of ganglionated plexus which are located on pulmonary vein (PV) antrum. The right anterior ganglionated plexi (RAGP) which located at superoanterior area of right superior PV antrum is an essential station to regulate the cardiac autonomic nerve activities and is easily coincidentally ablated during CPVI. The aim of this study is to assess the effect of RAGP ablation on vagal response (VR) during CPVI.
METHODS


A total of 80 patients with paroxysmal atrial fibrillation who underwent the first time CPVI were prospectively enrolled and randomly assigned to 2 groups: group A (n=40), CPVI started with right PVs at RAGP site; group B (n=40): CPVI started with left PVs first, and the last ablation site is RAGP. Electrophysiological parameters include basal cycle length, A-H interval, H-V interval, sinus node recovery time, and atrioventricular node Wenckebach point were recorded before and after CPVI procedure.
RESULTS


During CPVI, the positive VR were only observed on 1 patient in group A and 25 patients in group B ( P <0.001). A total of 21 patients with positive VR in group B needed for temporary ventricular pacing during procedure, while the only patient with positive VR in group A did not need for temporary ventricular pacing ( P <0.001). Compared with baseline, basal cycle length, sinus node recovery time, and atrioventricular node Wenckebach point were decreased significantly after CPVI procedure in both groups (all  P <0.05) and without differences between 2 groups.
CONCLUSIONS


Circumferential PV isolation initiated from RAGP could effectively inhibit VR occurrence and significantly increase heart rate during procedure.",2019,A did not need for temporary ventricular pacing ( P <0.001).,"['21 patients with', '80 patients with paroxysmal atrial fibrillation who underwent the first time CPVI']","['temporary ventricular pacing', 'Circumferential pulmonary vein isolation (CPVI', 'positive VR', 'RAGP ablation', 'CPVI started with right PVs at RAGP site']","['basal cycle length, A-H interval, H-V interval, sinus node recovery time, and atrioventricular node Wenckebach point', 'vagal response (VR', 'basal cycle length, sinus node recovery time, and atrioventricular node Wenckebach point', 'positive VR', 'temporary ventricular pacing', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037189', 'cui_str': 'Sinuatrial Node'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004247', 'cui_str': 'AV Node'}, {'cui': 'C0264907', 'cui_str': 'Mobitz type I incomplete atrioventricular block (disorder)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",80.0,0.0225212,A did not need for temporary ventricular pacing ( P <0.001).,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shangyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lishui', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Erpeng', 'Initials': 'E', 'LastName': 'Liang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007811']
3241,30187440,The Influence of a Home-Based Education Intervention on Family Caregivers' Knowledge and Self-Efficacy for Cancer Pain Management in Adult Patients Within a Resource-Limited Setting.,"Cancer-related pain is prevalent and has debilitating effects on patients and their family. The effects of cancer pain can be curtailed if the family members caring for the patient receive essential support to enhance their capabilities for cancer pain management. Little has been done to study the available support to family caregivers (FCGs) towards pain management in adult cancer patients (ACPs) living in resource-limited countries where the burden of cancer is on the rise. This study evaluated the influence of an education intervention delivered in the home setting on FCGs' knowledge and self-efficacy (SE) for pain management in ACPs. One-group pre-/post-test design was used in a sample of 54 FCGs who had been caring for ACPs suffering from pain for at least 1 month. Data were collected using the Family Pain Questionnaire and Caregiver Pain Management SE Scale. The FCGs' mean knowledge score post-intervention (26.69 ± 10) was higher than the baseline (45 ± 12.9), and the difference was statistically significant (t = 10.382, p = 0.000, CI = 17.12-25.43). Additionally, the FCGs' mean SE score post-intervention (1003.30 ± 191) was higher than the baseline (648.3 ± 273.4), and the difference was statistically significant (t = - 8.52, p = 0.000, CI = - 438.6-- 271.4). The home-based education intervention significantly and positively influenced the FCGs' knowledge and SE for pain management while at home. Cancer pain management educational interventions delivered at home should be considered as one of the strategies for enhancing cancer care in resource limited settings.",2019,The home-based education intervention significantly and positively influenced the FCGs' knowledge and SE for pain management while at home.,"['pain management in ACPs', 'adult cancer patients (ACPs) living in resource-limited countries', 'Adult Patients Within a Resource-Limited Setting', '54 FCGs who had been caring for ACPs suffering from pain for at least 1\xa0month']","['Home-Based Education Intervention', 'education intervention']","['Family Pain Questionnaire and Caregiver Pain Management SE Scale', ""FCGs' knowledge and SE for pain management""]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.020725,The home-based education intervention significantly and positively influenced the FCGs' knowledge and SE for pain management while at home.,"[{'ForeName': 'Irene Betty', 'Initials': 'IB', 'LastName': 'Kizza', 'Affiliation': 'Department of Adult Health and Critical Care, College of Nursing, Sultan Qaboos University, P. O. Box 66, Al Khod, Muscat, Oman. irenekizza@gmail.com.'}, {'ForeName': 'Joshua Kanaabi', 'Initials': 'JK', 'LastName': 'Muliira', 'Affiliation': 'Department of Adult Health and Critical Care, College of Nursing, Sultan Qaboos University, P. O. Box 66, Al Khod, Muscat, Oman.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1421-x']
3242,31190459,Cluster randomized controlled trial testing the effectiveness of a self-management intervention using the teach-back method for people with heart failure.,"In this study, we examined the effectiveness of a self-management intervention delivered to people with heart failure in Vietnam. It used teach-back, a cyclical method of teaching content, checking comprehension, and re-teaching to improve understanding. A single-site cluster randomized controlled trial was conducted, and six hospital wards were randomized into two study groups. On the basis of ward allocation, 140 participants received either usual care or the teach-back heart failure self-management intervention plus usual care. The intervention involved, prior to discharge, an individual educational session on heart failure self-care, with understanding reinforced using teach-back, a heart failure booklet, weighing scales, diary, and a follow-up phone call 2 weeks post-discharge. The control group received usual care and the booklet. Outcomes were heart failure knowledge, self-care (maintenance, management and confidence), and all-cause hospitalizations assessed at 1 and 3 months (end-point). Upon completion of the study, the intervention group had significantly greater knowledge and self-care maintenance than the control group. Other outcomes did not differ between the two groups. The teach-back self-management intervention demonstrated promising benefits in promoting self-care for heart failure patients.",2019,"Outcomes were heart failure knowledge, self-care (maintenance, management and confidence), and all-cause hospitalizations assessed at 1 and 3 months (end-point).","['people with heart failure', '140 participants received either', 'six hospital wards', 'people with heart failure in Vietnam', 'heart failure patients']","['self-management intervention', 'usual care or the teach-back heart failure self-management intervention plus usual care', 'usual care and the booklet']","['heart failure knowledge, self-care (maintenance, management and confidence), and all-cause hospitalizations', 'knowledge and self-care maintenance']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",140.0,0.0576458,"Outcomes were heart failure knowledge, self-care (maintenance, management and confidence), and all-cause hospitalizations assessed at 1 and 3 months (end-point).","[{'ForeName': 'Ha T T', 'Initials': 'HTT', 'LastName': 'Dinh', 'Affiliation': 'Faculty of Nursing and Midwifery, Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bonner', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ramsbotham', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Clark', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Nursing & health sciences,['10.1111/nhs.12616']
3243,31158474,Insulin sensitivity improvement with exercise training is mediated by body weight loss in subjects with metabolic syndrome.,"AIM


To determine whether exercise training improves insulin actions through concomitant body weight loss (BWL).
METHODS


Subjects (aged 55±8 years) with metabolic syndrome (MetS), prediabetes (fasting blood glucose: 111±2mg·dL -1 , HbA1c: 5.85±0.05%) and abdominal obesity (waist circumference: 104±7.9cm) were randomly allocated to either a group performing aerobic interval training (EXER; n=76) or a sedentary group receiving lifestyle counselling (CONT; n=20) for 16 weeks.
RESULTS


At baseline, insulin sensitivity (according to HOMA2 and intravenous glucose tolerance test; CS I ), body composition and VO 2max  were similar between the groups. After the intervention, both groups had similar BWL (1-2%), but only the EXER group showed decreased [mean (95% CI)] trunk fat mass [from 18.2 (17.4-18.9) to 17.3kg (16.6-17.9); P<0.001] and HOMA2 scores [from 1.6 (1.5-1.7) to 1.4 (1.3-1.5); P=0.001], and increased VO 2max  [from 2.07 (1.92-2.21) to 2.28 (2.11-2.45) LO 2 ·min -1 ; P<0.001]. However, CS I  did not improve in any group. Within-group subdivision by BWL (≤0%, 0-3%, ≥3%) revealed higher CS I  in those with BWL≥3% in both groups. Trunk fat mass reductions were closely associated with CS I  and HOMA-IR improvement (r=-0.452-0.349; P<0.001).
CONCLUSION


In obese MetS subjects with prediabetes, 3% BWL is required for consistent improvement in insulin sensitivity. Thus, exercise-training programmes should be combined with calorie restriction to achieve BWL levels that prevent the development of diabetes.",2020,"Trunk fat mass reductions were closely associated with CS I  and HOMA-IR improvement (r=-0.452-0.349; P<0.001).
","['subjects with metabolic syndrome', 'Subjects (aged 55±8 years) with metabolic syndrome (MetS), prediabetes (fasting blood glucose: 111±2mg·dL']","['exercise training', 'aerobic interval training (EXER; n=76) or a sedentary group receiving lifestyle counselling (CONT']","['VO 2max', 'insulin sensitivity', 'Trunk fat mass reductions', 'insulin actions through concomitant body weight loss (BWL', 'insulin sensitivity (according to HOMA2 and intravenous glucose tolerance test; CS I ), body composition and VO 2max', 'higher CS', 'similar BWL', 'HOMA2 scores', 'trunk fat mass', 'abdominal obesity']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance Test'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}]",,0.0557464,"Trunk fat mass reductions were closely associated with CS I  and HOMA-IR improvement (r=-0.452-0.349; P<0.001).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, Sports sciences, University of Castilla-La Mancha, Avda. Carlos III s.n, 45071 Toledo, Spain. Electronic address: ricardo.mora@uclm.es.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, Sports sciences, University of Castilla-La Mancha, Avda. Carlos III s.n, 45071 Toledo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, Sports sciences, University of Castilla-La Mancha, Avda. Carlos III s.n, 45071 Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, Sports sciences, University of Castilla-La Mancha, Avda. Carlos III s.n, 45071 Toledo, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, Sports sciences, University of Castilla-La Mancha, Avda. Carlos III s.n, 45071 Toledo, Spain.'}]",Diabetes & metabolism,['10.1016/j.diabet.2019.05.004']
3244,31775954,The Delivery of a Short-Term Psychological Skills Training Program to College Dance Students: A Pilot Study Examining Coping Skills and Injuries.,"Dance makes a number of inherent physical and psychosocial demands that can promote resilience. However, dancers may strive to meet those demands by employing unhealthy coping strategies that can be linked to maladaptive thoughts and behaviors and increased injury risk. The present study utilized a two-group pretest-posttest quasi-experimental design to examine the impact of a psychological skills training program on coping skills and prevalence of injuries over a 6-week period in a convenience sample of college dance students (N = 30). Participants were drawn from the same dance program and were assigned to a control or treatment condition based on their current class schedule. At the end of the study, there were no significant quantitative differences observed between the treatment and control groups. However, mean scores for treatment group participants' coping skills slightly increased over time. A focus group discussion led to several recommendations for future research and programming improvements. Additionally, this study underscores the need for a single operational definition of injury in a college dance context. Best practices for researchers, practitioners, and educators in the context of psychological skills training are also discussed.",2019,"However, mean scores for treatment group participants' coping skills slightly increased over time.","['College Dance Students', 'convenience sample of college dance students (N = 30']","['psychological skills training program', 'Short-Term Psychological Skills Training Program']",['coping skills'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0086059', 'cui_str': 'Coping Skills'}]",,0.0115337,"However, mean scores for treatment group participants' coping skills slightly increased over time.","[{'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Skvarla', 'Affiliation': 'West Virginia University, Morgantown, West Virginia, USA;, Email: Lbryant1@mix.wvu.edu.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Clement', 'Affiliation': 'West Virginia University, Morgantown, West Virginia, USA.'}]",Journal of dance medicine & science : official publication of the International Association for Dance Medicine & Science,['10.12678/1089-313X.23.4.159']
3245,31281005,A feasibility of simulation-based exercise programme for overweight adult in higher learning institutions.,"OBJECTIVE


This study was conducted to evaluate the feasibility of simulation-based exercise programme among overweight adult in higher learning institutes.
METHOD


A quasi-randomized controlled trial was conducted recruiting students from two different higher learning institutions in Kuantan, Pahang, Malaysia. Students are selected after fulfilling the criteria such as body mass index (BMI) of ≥23kg/m 2 , no chronic diseases that may influence by exercise, no significant changes in body weight within two months and not taking any medications or supplements. One institution was purposely chosen as a simulation-based group and another one control group. In the simulation-based group, participants were given a booklet and CD to do aerobic and resistance exercise for a minimum of 25min per day, three times a week for 10 weeks. No exercise was given to the control group. Participants were measured with the International Physical Activity Questionnaire (IPAQ), BMI, waist circumference (WC), body fat percentage before and after 10 weeks of simulation-based exercise.
RESULTS


A total of 52 (control: 25, simulation-based: 27) participants involved in the study. There was no baseline characteristics difference between the two groups (p>0.005). All 27 participants in the simulation-based group reported performing the exercise based on the recommendation. The retention rate at three months was 100%. No adverse events were reported throughout the study. Better outcomes (p<0.001) were reported among participants in the simulation-based group for BMI, WC and body fat percentage.
CONCLUSIONS


The findings of this study indicate that the simulation-based exercise programme may be feasible for an overweight adult in higher learning institutes. As a feasibility study this is not powered to detect significant differences on the outcomes. However, participants reported positive views towards the recommended exercise with significant improvements in body mass index, body fat percentage and reduced the waist circumference.",2019,"Better outcomes (p<0.001) were reported among participants in the simulation-based group for BMI, WC and body fat percentage.
","['A quasi-randomized controlled trial was conducted recruiting students from two different higher learning institutions in Kuantan, Pahang, Malaysia', 'overweight adult in higher learning institutions', 'overweight adult in higher learning institutes', 'A total of 52 (control: 25, simulation-based: 27) participants involved in the study']","['booklet and CD to do aerobic and resistance exercise', 'simulation-based exercise programme']","['adverse events', 'International Physical Activity Questionnaire (IPAQ), BMI, waist circumference (WC), body fat percentage', 'retention rate', 'body mass index, body fat percentage and reduced the waist circumference', 'BMI, WC and body fat percentage', 'body weight']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0527686,"Better outcomes (p<0.001) were reported among participants in the simulation-based group for BMI, WC and body fat percentage.
","[{'ForeName': 'Nik Siti Rahmah', 'Initials': 'NSR', 'LastName': 'Nik Yahya', 'Affiliation': 'Department of Medical-Surgical Nursing, Kulliyyah of Nursing, International Islamic University Malaysia, Pahang, Malaysia.'}, {'ForeName': 'Farrah Ilyani Che', 'Initials': 'FIC', 'LastName': 'Jamaludin', 'Affiliation': 'Department of Medical-Surgical Nursing, Kulliyyah of Nursing, International Islamic University Malaysia, Pahang, Malaysia.'}, {'ForeName': 'Mohd Khairul Zul Hasymi', 'Initials': 'MKZH', 'LastName': 'Firdaus', 'Affiliation': 'Department of Medical-Surgical Nursing, Kulliyyah of Nursing, International Islamic University Malaysia, Pahang, Malaysia.'}, {'ForeName': 'Muhammad Kamil', 'Initials': 'MK', 'LastName': 'Che Hasan', 'Affiliation': 'Department of Medical-Surgical Nursing, Kulliyyah of Nursing, International Islamic University Malaysia, Pahang, Malaysia. Electronic address: mkamil@iium.edu.my.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.079']
3246,31225625,Potential Moderating Effects of Sex/Gender on the Acute Relative Reinforcing and Subjective Effects of Reduced Nicotine Content Cigarettes in Vulnerable Populations.,"INTRODUCTION


Reports in relatively healthy smokers suggest men are more sensitive than women to the subjective effects of reduced nicotine content cigarettes (RNCCs). We know of no reports examining sex differences in the relative reinforcing effects of RNCCs, an important outcome in assessing smoking's addiction potential. The aim of the present study is to address this gap by examining sex/gender differences on reinforcing effects while examining whether sex differences in subjective effects are discernible in vulnerable populations.
METHODS


Secondary analysis of a within-subject, double-blinded experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage. Effects of dose, sex, and their interaction were examined on reinforcing (concurrent-choice and Cigarette Purchase Task [CPT] testing), and subjective effects (Cigarette Evaluation Questionnaire [CEQ] and craving/withdrawal ratings).
RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose × sex/gender interactions. Reducing nicotine content decreased CEQ ratings with only a single significant effect of sex (higher Psychological Reward scores among women than men, p = .02) and no significant dose × sex/gender interactions. Results on craving/withdrawal paralleled those on the CEQ.
CONCLUSIONS


Reducing nicotine content decreases the addiction potential of smoking independent of sex in populations highly vulnerable to smoking and addiction, with no indication that women are less sensitive to subjective effects of RNCCs or would benefit less from a policy reducing the nicotine content of cigarettes.
IMPLICATIONS


A policy reducing the nicotine content of cigarettes has the potential to reduce the addiction potential of smoking across men and women who are especially vulnerable to smoking, addiction, and tobacco-related adverse health impacts.",2020,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","['Vulnerable Populations', 'healthy smokers suggest men', 'Secondary analysis of a within-subject, double-blind experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage']",['Nicotine Content Cigarettes'],"['CEQ ratings', 'reinforcing (concurrent-choice and Cigarette Purchase Task (CPT) testing), and subjective effects (Cigarette Evaluation Questionnaire (CEQ) and craving/withdrawal ratings']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",169.0,0.0258027,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Ellaina', 'Initials': 'E', 'LastName': 'Reed', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz098']
3247,31274827,Missing expectations: Windlass tourniquet use without formal training yields poor results.,"BACKGROUND


Despite significant attempts to educate civilians in hemorrhage control, the majority remain untrained. We sought to determine if laypersons can successfully apply one of three commercially available tourniquets; including those endorsed by the United States Military and the American College of Surgeons.
METHODS


Preclinical graduate health science students were randomly assigned a commercially available windless tourniquet: SAM XT, Combat Application Tourniquet (CAT), or Special Operation Forces Tactical Tourniquet (SOFT-T). Each was given up to 1 minute to read package instructions and asked to apply it to the HapMed Leg Tourniquet Trainer. Estimated blood loss was measured until successful hemostatic pressure was achieved or simulated death occurred from exsanguination. Simulation survival, time to read instructions and stop bleeding, tourniquet pressure, and blood loss were analyzed.
RESULTS


Of the 150 students recruited, 55, 46, and 49 were randomized to the SAM XT, CAT, SOFT-T, respectively. Mean overall simulation survival was less than 66% (65%, 72%, 61%; p = 0.55). Of survivors, all three tourniquets performed similarly in median pressure applied (319, 315, and 329 mm Hg; p = 0.54) and median time to stop bleeding (91, 70, 77 seconds; p = 0.28). There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT, 686 mL; CAT, 624 mL; SOFT-T, 433 mL; p = 0.03). All 16 participants with previous experience were able to successfully place the tourniquet compared with 81 (62%) of 131 first-time users (p = 0.008).
CONCLUSION


No one should die of extremity hemorrhage, and civilians are our first line of defense. We demonstrate that when an untrained layperson is handed a commonly accepted tourniquet, failure is unacceptably high. Current devices are not intuitive and require training beyond the enclosed instructions. Plans to further evaluate this cohort after formal ""Stop the Bleed"" training are underway.",2019,"There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT 686 ml, CAT 624 ml, SOFT-T 433 ml; p=0.03).","['those endorsed by the United States Military and the American College of Surgeons', 'Pre-clinical graduate health science students', 'Of the 150 students recruited, 55, 46, and 49']","['commercially-available windless tourniquet: SAM® XT, Combat Application Tourniquet® (CAT), or Special Operation Forces® Tactical Tourniquet (SOFT-T']","['Estimated blood loss', 'Simulation survival, time to read instructions and stop bleeding, tourniquet pressure, and blood loss', 'median pressure', 'median time to stop bleeding', 'median blood loss volume', 'Mean overall simulation survival']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0599022,"There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT 686 ml, CAT 624 ml, SOFT-T 433 ml; p=0.03).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dennis', 'Affiliation': 'From the Department of Trauma and Burn Surgery, Cook County Health (A.D., F.Ba., V.S., L.C.T., C.B., M.K., T.M., F.S., J.M., F.Bo.); Department of Surgery, Rush University (A.D., V.S., L.C.T., C.B., T.M., F.S. F.Bo.), Chicago; Department of Surgery, Midwestern University (A.D., V.S., L.C.T., A.I., K.I., A.L., T.P., F.S., J.M.), Downers Grove, Illinois.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bajani', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Schlanser', 'Affiliation': ''}, {'ForeName': 'Leah C', 'Initials': 'LC', 'LastName': 'Tatebe', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Impens', 'Affiliation': ''}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ivkovic', 'Affiliation': ''}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pickett', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kaminsky', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Messer', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Starr', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Mis', 'Affiliation': ''}, {'ForeName': 'Faran', 'Initials': 'F', 'LastName': 'Bokhari', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002431']
3248,31318721,A Randomized Trial to Increase the Assessment Accuracy of Glaucoma and Optic Disc Characteristics by Orthoptists.,"INTRODUCTION


The aim of this study was to determine the accuracy of orthoptists when examining the optic disc for signs of glaucoma, and to explore the impact of targeted clinical education on accuracy.
METHODS


In this randomized controlled trial, 42 monoscopic color optic disc images were presented to 46 orthoptists who assessed the likelihood of glaucoma as well as optic disc size, shape, tilting, vertical cup-to-disc ratio, cup shape, depth, presence of hemorrhage, peripapillary atrophy, and retinal nerve fiber layer. The level of agreement with specialist ophthalmologists was assessed. Participants were then randomly assigned to an experimental group (targeted postgraduate education on optic disc assessment) or to no intervention. The educational program was designed to increase knowledge of the characteristic features associated with glaucomatous optic neuropathy. All participants re-examined the included optic disc images after a period of 6 to 8 weeks. The primary outcome measure was a change in agreement between attempts.
RESULTS


The education group showed significant improvements between attempts for identifying hemorrhages (P = .013), retinal nerve fiber layer defects (0.035), disc size (P = .001), peripapillary atrophy (P = .030), and glaucoma likelihood (P = .023). The control group did not show any statistically significant improvement. The intervention group showed significantly more improvement when identifying hemorrhages (P = .013), disc size (P = .001), disc shape (P = .033), and cup shape (P = .020) compared with the control group.
DISCUSSION


Orthoptists who received additional postgraduate online education based on principles of adult learning were more accurate at assessing the optic disc for glaucoma. These results highlight the value of continuing education to optimize clinical practice in allied health professionals.",2019,"The education group showed significant improvements between attempts for identifying hemorrhages (P = .013), retinal nerve fiber layer defects (0.035), disc size (P = .001), peripapillary atrophy (P = .030), and glaucoma likelihood (P = .023).","['42 monoscopic color optic disc images were presented to 46 orthoptists who assessed the likelihood of glaucoma as well as optic disc size, shape, tilting, vertical cup-to-disc ratio, cup shape, depth, presence of hemorrhage, peripapillary atrophy, and retinal nerve fiber layer']","['experimental group (targeted postgraduate education on optic disc assessment) or to no intervention', 'additional postgraduate online education']","['retinal nerve fiber layer defects', 'glaucoma likelihood', 'peripapillary atrophy', 'change in agreement between attempts', 'cup shape', 'identifying hemorrhages', 'disc shape', 'disc size']","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0029127', 'cui_str': 'Optic Nerve Head'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0402016', 'cui_str': 'Orthoptist (occupation)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C1720158', 'cui_str': 'Optic disc size'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C1719838', 'cui_str': 'Peripapillary atrophy'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0029127', 'cui_str': 'Optic Nerve Head'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4505477', 'cui_str': 'Online Learning'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C1719838', 'cui_str': 'Peripapillary atrophy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.0674301,"The education group showed significant improvements between attempts for identifying hemorrhages (P = .013), retinal nerve fiber layer defects (0.035), disc size (P = .001), peripapillary atrophy (P = .030), and glaucoma likelihood (P = .023).","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Scheetz', 'Affiliation': 'Dr. Scheetz: Post-doctoral Research Fellow,Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia. Dr. Koklanis: Head of Discipline, Orthoptics, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia. Dr. McGuinness: Biostatistician,Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia. Dr. Long: Senior Lecturer, School of Allied Health, Human Services and Sport, School of Allied Health, La Trobe University, Melbourne, Australia. Professor Morris: Professor of Clinical and Rehabilitation Practice, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia, and North Eastern Rehabilitation Center, Healthscope, Ivanhoe, Australia.'}, {'ForeName': 'Konstandina', 'Initials': 'K', 'LastName': 'Koklanis', 'Affiliation': ''}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'McGuinness', 'Affiliation': ''}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': ''}]",The Journal of continuing education in the health professions,['10.1097/CEH.0000000000000258']
3249,31256683,Transient Increase of Wavefront Aberrations after Horizontal Rectus Muscle Surgery in Exotropia.,"Aims : Wavefront aberration (WA) has become one of the important indicators for measuring the visual quality. Whether strabismus surgery affects the WA remain controversial. This study aims to investigate the postoperative alterations of WA in patients who underwent horizontal rectus muscle surgery. Methods : A total of 34 patients were enrolled and divided into two groups: bilateral lateral rectus recession (BLR) group and unilateral lateral rectus recession and medial rectus resection (R&R) group. The WA was examined 1 day before surgery, 3 days, and 6 weeks after surgery using the iTrace Visual Function Analyzer (Tracey Technologies). Results : Significant increases in total WA, lower-order aberration (LOA) and higher-order aberration (HOA) of both groups were detected in 3 days after surgery ( P  < 0.05), while no significant differences in 6 weeks after surgery. Significant increases in astigmatism, secondary astigmatism, and trefoil of both groups were detected in 3 days after surgery ( P  < 0.05), while no significant differences in individual order of LOA and HOA in 6 weeks postoperatively. Z 2 2 , Z 3 3 , and Z 4 2  of both groups increased significantly 3 days after surgery ( P  < 0.05) and returned to baseline level 6 weeks after surgery, while the rest Zernike coefficients remained the same postoperatively. When comparing the differences between the two groups, there were no statistically significant differences in these parameters between baseline and each follow-up visit postoperatively. Conclusions : The increase of WA restored to pre-operative level in 6 weeks after surgery, indicating the influences of horizontal rectus muscle surgery to WA were transient and reversible.",2019,"Significant increases in astigmatism, secondary astigmatism and trefoil of both groups were detected in 3 days after surgery ( P <0.05), while no significant differences in individual order of LOA and HOA in 6 weeks postoperatively.","['patients who underwent horizontal rectus muscle surgery', '34 patients']","['Wavefront aberration (WA', 'bilateral lateral rectus recession (BLR) group and unilateral lateral rectus recession and medial rectus resection (R&R) group']","['individual order of LOA and HOA', 'astigmatism, secondary astigmatism and trefoil', 'Wavefront Aberrations', 'total WA, lower-order aberration (LOA) and higher-order aberration (HOA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0448311', 'cui_str': 'Rectus eye muscle structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1532952', 'cui_str': 'Wavefront aberration'}, {'cui': 'C0395290', 'cui_str': 'Bilateral lateral rectus recession (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0395287', 'cui_str': 'Lateral rectus recession and medial rectus resection (procedure)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0023923', 'cui_str': 'Loa'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C1532251', 'cui_str': 'Secondary astigmatism'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",34.0,0.042288,"Significant increases in astigmatism, secondary astigmatism and trefoil of both groups were detected in 3 days after surgery ( P <0.05), while no significant differences in individual order of LOA and HOA in 6 weeks postoperatively.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Eye Institute of Xiamen University, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, School of Medicine, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuangzhen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jieyue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shengfa', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Current eye research,['10.1080/02713683.2019.1638417']
3250,29412001,Training the Anesthesiologist Trainer: Enhancing the Quality of Feedback during Human Patient Simulations.,"An essential piece of anesthesiologist training is attending resident feedback sessions. Yet, few attending anesthesiologists have formal teaching education and little time to acquire it. In this field experiment, attending physicians were randomly assigned to a control group or to receive 30 minutes of feedback training inspired by Implicit Person Theory (IPT). As such, IPT training encouraged physicians to praise process-oriented learning while discouraging performance-oriented mindsets. Attending physicians then observed residents participate in a human patient simulation (HPS) activity and provided residents with feedback. Content and statistical analyses revealed trained attending physicians praised learning goals and challenged performance goals more often than untrained physicians during feedback sessions. Thus, the training provides a rapid method of enhancing the quality of attending physicians' training communication.",2019,Content and statistical analyses revealed trained attending physicians praised learning goals and challenged performance goals more often than untrained physicians during feedback sessions.,"['attending physicians', 'Attending physicians then observed residents participate in a human patient simulation (HPS) activity and provided residents with feedback']","['IPT training', 'control group or to receive 30\xa0minutes of feedback training inspired by Implicit Person Theory (IPT']",[],"[{'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",[],,0.0118302,Content and statistical analyses revealed trained attending physicians praised learning goals and challenged performance goals more often than untrained physicians during feedback sessions.,"[{'ForeName': 'Elissa A', 'Initials': 'EA', 'LastName': 'Adame', 'Affiliation': 'a Hugh Downs School of Human Communication, Arizona State University.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Bisel', 'Affiliation': 'b The Department of Communication , The University of Oklahoma.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kosik', 'Affiliation': 'c Department of Anesthesiology , The University of Oklahoma.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Rygaard', 'Affiliation': 'd Practicing Anesthesiologist , Oklahoma City.'}]",Health communication,['10.1080/10410236.2018.1431019']
3251,31856882,Evaluating the implementation of the PACE Steps to Success Programme in long-term care facilities in seven countries according to the RE-AIM framework.,"BACKGROUND


The PACE 'Steps to Success' programme is a complex educational and development intervention for staff to improve palliative care in long-term care facilities (LTCFs). In a cluster randomized controlled trial, this programme has been implemented in 37 LTCFs in 7 European countries. Alongside an effectiveness study, a process evaluation study was conducted. This paper reports on the results of this process evaluation, of which the aim was to provide a more detailed understanding of the implementation of the PACE Programme across and within countries.
METHODS


The process evaluation followed the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and involved various measures and tools, including diaries for country trainers, evaluation questionnaires for care staff, attendance lists and interviews (online and face-to-face, individual and in groups) with country trainers, managers, PACE coordinators and other staff members. Based on key elements of the PACE Programme, a priori criteria for a high, medium and low level of the RE-AIM components Reach, Adoption, Implementation and intention to Maintenance were defined. Qualitative data on factors affecting each RE-AIM component gathered in the online discussion groups and interviews were analysed according to the principles of thematic analysis.
RESULTS


The performance of the PACE Programme on the RE-AIM components was highly variable within and across countries, with a high or medium score for in total 28 (out of 37) LTCFs on Reach, for 26 LTCFs on Adoption, for 35 LTCFs on Implementation and for 34 LTCFs on intention to Maintenance. The factors affecting performance on the different RE-AIM components could be classified into three major categories: (1) the PACE Programme itself and its way of delivery, (2) people working with the PACE Programme and (3) contextual factors. Several country-specific challenges in implementing the PACE Programme were identified.
CONCLUSIONS


The implementation of the PACE Programme was feasible but leaves room for improvement. Our analysis helps to better understand the optimal levels of training and facilitation and provides recommendations to improve implementation in the LTC setting. The results of the process evaluation will be used to further adapt and improve the PACE Programme prior to its further dissemination.
TRIAL REGISTRATION


The PACE study was registered at www.isrctn.com-ISRCTN14741671 (FP7-HEALTH-2013-INNOVATION-1 603111) July 30, 2015.",2019,"BACKGROUND


The PACE 'Steps to Success' programme is a complex educational and development intervention for staff to improve palliative care in long-term care facilities (LTCFs).","['37 LTCFs in 7 European countries', 'and in groups) with country trainers, managers, PACE coordinators and other staff members']",[],"['Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and involved various measures and tools, including diaries for country trainers, evaluation questionnaires for care staff, attendance lists and interviews (online and face-to-face, individual']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]",[],"[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0453782,"BACKGROUND


The PACE 'Steps to Success' programme is a complex educational and development intervention for staff to improve palliative care in long-term care facilities (LTCFs).","[{'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Oosterveld-Vlug', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. m.oosterveld@vumc.nl.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Onwuteaka-Philipsen', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Ten Koppel', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'van Hout', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pivodic', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tanghe', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van Den Noortgate', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hockley', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Danni Collingridge', 'Initials': 'DC', 'LastName': 'Moore', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Violetta', 'Initials': 'V', 'LastName': 'Kijowska', 'Affiliation': 'Unit for Research on Ageing Society, Epidemiology and Preventive Medicine Chair, Medical Faculty, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbińska', 'Affiliation': 'Unit for Research on Ageing Society, Epidemiology and Preventive Medicine Chair, Medical Faculty, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Leppäaho', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mercuri', 'Affiliation': 'Department of Internal Medicine & Geriatrics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rossi', 'Affiliation': 'Department of Internal Medicine & Geriatrics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mercuri', 'Affiliation': 'Department of Internal Medicine & Geriatrics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Department of Internal Medicine & Geriatrics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bassal', 'Affiliation': 'Center for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Emilie Morgan', 'Initials': 'EM', 'LastName': 'de Paula', 'Affiliation': 'HE-Arc Santé, HES-SO University of Applied Sciences and Arts Western Switzerland, Neuchâtel, Switzerland.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'H Roeline', 'Initials': 'HR', 'LastName': 'Pasman', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Implementation science : IS,['10.1186/s13012-019-0953-8']
3252,31429960,Of Drowning Children and Doubtful Analogies.,"In this issue of the Hastings Center Report, James Sabin and his colleagues ask what responsibility investigators in a learning health organization have to patients when research-particularly research of which patients might be unaware-illuminates problematic aspects of the patients' care. Sabin and his colleagues were confronted by this question in the midst of designing a randomized controlled trial that sought to determine if an educational intervention targeted at patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants. Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround."" But the ""workaround,"" I suggest, was not a solution to the negligent bystander problem. Nor was it a solution to the problem as I would alternatively frame it-how to address instances of suboptimal patient care identified through research within learning health organizations.",2019,"Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround.""",['patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]",[],[],,0.0344128,"Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround.""","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Largent', 'Affiliation': ''}]",The Hastings Center report,['10.1002/hast.1032']
3253,31613029,Speeding of oxygen uptake kinetics is not different following low-intensity blood-flow-restricted and high-intensity interval training.,"NEW FINDINGS


What is the central question of this study? Can interval blood-flow-restricted (BFR) cycling training, undertaken at a low intensity, promote a similar adaptation to oxygen uptake (    V   ̇   O   2      ) kinetics to high-intensity interval training? What is the main finding and its importance? Speeding of pulmonary    V   ̇   O   2      on-kinetics in healthy young subjects was not different between low-intensity interval BFR training and traditional high-intensity interval training. Given that very low workloads are well tolerated during BFR cycle training and speed    V   ̇   O   2      on-kinetics, this training method could be used when high mechanical loads are contraindicated.
ABSTRACT


Low-intensity blood-flow-restricted (BFR) endurance training is effective to increase aerobic capacity. Whether it speeds pulmonary oxygen uptake (    V   ̇   O   2   p      ), CO 2  output (    V   ̇   C   O   2   p      ) and ventilatory (    V   ̇   Ep      ) kinetics has not been examined. We hypothesized that low-intensity BFR training would reduce the phase 2 time constant (τ p  ) of    V   ̇   O   2   p      ,    V   ̇   C   O   2   p      and    V   ̇   Ep      by a similar magnitude to traditional high-intensity interval training (HIT). Low-intensity interval training with BFR served as a control. Twenty-four participants (25 ± 6 years old; maximal    V   ̇   O   2      46 ± 6 ml kg -1   min -1  ) were assigned to one of the following: low-intensity BFR interval training (BFR; n = 8); low-intensity interval training without BFR (LOW; n = 7); or high-intensity interval training without BFR (HIT; n = 9). Training was 12 sessions of two sets of five to eight × 2 min cycling and 1 min resting intervals. LOW and BFR were conducted at 30% of peak incremental power (P peak  ), and HIT was at ∼103% P peak  . For BFR, cuffs were inflated on both thighs (140-200 mmHg) during exercise and deflated during rest intervals. Six moderate-intensity step transitions (30% P peak  ) were averaged for analysis of pulmonary on-kinetics. Both BFR (pre- versus post-training τ p   = 18.3 ± 3.2 versus 14.5 ± 3.4 s; effect size = 1.14) and HIT (τ p   = 20.3 ± 4.0 versus 13.1 ± 2.9 s; effect size = 1.75) reduced the    V   ̇   O   2   p      τ p  (P < 0.05). As expected, there was no change in LOW (    V   ̇   O   2   p      τ p   = 17.9 ± 6.2 versus 17.7 ± 4.3 s; P = 0.9). The kinetics of    V   ̇   C   O   2   p      and    V   ̇   Ep      were speeded only after HIT (38.5 ± 10.6%, P < 0.001 and 31.2 ± 24.7%, P = 0.004, respectively). Both HIT and low-intensity BFR training were effective in speeding moderate-intensity    V   ̇   O   2   p      kinetics. These data support the findings of others that low-intensity cycling training with BFR increases muscle oxidative capacity.",2019,reduced the    V   ̇   O   2   p      τ p  (P < 0.05).,"['healthy young subjects', 'Twenty-four participants (25\xa0±\xa06\xa0years old; maximal    V   ̇', '46\xa0±']","['C   O   2   p      and    V   ̇', 'low-intensity BFR interval training (BFR; n\xa0=\xa08); low-intensity interval training without BFR (LOW; n\xa0=\xa07); or high-intensity interval training without BFR', 'low-intensity BFR training', 'HIT and low-intensity BFR training']","['kinetics of    V   ̇', 'LOW and BFR', 'LOW (    V   ̇', 'muscle oxidative capacity', 'CO 2  output (    V   ̇   C   O   2   p      ) and ventilatory (    V   ̇']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",24.0,0.0328762,reduced the    V   ̇   O   2   p      τ p  (P < 0.05).,"[{'ForeName': 'Rogério B', 'Initials': 'RB', 'LastName': 'Corvino', 'Affiliation': 'Human Performance Research Group, Center for Health and Exercise Science, Santa Catarina State University, Florianopolis, Brazil.'}, {'ForeName': 'Mariana F M', 'Initials': 'MFM', 'LastName': 'Oliveira', 'Affiliation': 'Human Performance Research Group, Center for Health and Exercise Science, Santa Catarina State University, Florianopolis, Brazil.'}, {'ForeName': 'Benedito S', 'Initials': 'BS', 'LastName': 'Denadai', 'Affiliation': 'Physical Effort Laboratory, Sports Center, Federal University of the State of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Harry B', 'Initials': 'HB', 'LastName': 'Rossiter', 'Affiliation': 'Division of Pulmonary and Critical Care Physiology and Medicine, Rehabilitation Clinical Trials Center, Los Angeles Biomedical Research Center at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Caputo', 'Affiliation': 'Human Performance Research Group, Center for Health and Exercise Science, Santa Catarina State University, Florianopolis, Brazil.'}]",Experimental physiology,['10.1113/EP087727']
3254,31568636,Platelet-rich plasma treatment for melasma: A pilot study.,"BACKGROUND


Melasma treatments have varying success and are associated with some complications.
AIMS


To assess the effectiveness of platelet-rich plasma (PRP) treatment for melasma.
METHODS


Ten female patients with bilateral mixed-type melasma were enrolled in our randomized, split-face, single-blinded prospective trial. Over 4 treatment sessions that each took place every 2 weeks, PRP was injected intradermally on one side of the face (PRP condition) and normal saline on the other (control condition). PRP was prepared by using the YCELLBIO Kit ®  . Outcomes were evaluated with the modified Melasma Area and Severity Index (mMASI), Mexameter ®  , and Antera ®  3D. Patient satisfaction was also assessed at baseline, at 2, 4, and 6 weeks, and 1 month after treatment completion.
RESULTS


mMASI score and Antera ®  3D-assessed melanin levels show significant improvement in the PRP condition than control condition between baseline and week 6, while patient satisfaction significantly increased over time. However, Mexameter ®  -assessed erythema and melanin indices did not significantly differ between the control and PRP conditions, though there was a trend toward reduced pigmentation in the latter. Finally, side effects of treatment were mild and resolved spontaneously within a few days.
CONCLUSION


This is the first randomized, placebo-controlled trial study using PRP for treatment of melasma. PRP injection significantly improved melasma within 6 weeks of treatment in terms of mMASI scores, patient satisfaction, and Antera ®  -assessed melanin levels. Hence, intradermal PRP injection could be used as an alternative or adjuvant therapy for melasma. However, additional trials are needed for more rigorous evaluation of its long-term efficacy and safety.",2020,"However, Mexameter ®  -assessed erythema and melanin indices did not significantly differ between the control and PRP conditions, though there was a trend toward reduced pigmentation in the latter.","['Ten female patients with bilateral mixed-type melasma', 'melasma']","['PRP was injected intradermally on one side of the face (PRP condition) and normal saline', 'platelet-rich plasma (PRP', 'Platelet-rich plasma treatment', 'placebo', 'PRP injection', 'PRP']","['Mexameter ®  -assessed erythema and melanin indices', 'patient satisfaction', 'mMASI score and Antera ®  3D-assessed melanin levels', 'modified Melasma Area and Severity Index (mMASI), Mexameter ®  , and Antera ®  3D. Patient satisfaction']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",10.0,0.124922,"However, Mexameter ®  -assessed erythema and melanin indices did not significantly differ between the control and PRP conditions, though there was a trend toward reduced pigmentation in the latter.","[{'ForeName': 'Punyaphat', 'Initials': 'P', 'LastName': 'Sirithanabadeekul', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Arada', 'Initials': 'A', 'LastName': 'Dannarongchai', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Atchima', 'Initials': 'A', 'LastName': 'Suwanchinda', 'Affiliation': 'Department of Dermatology, School of AntiAging and Regenerative Medicine, Mae Fah Luang University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13157']
3255,31120614,The LAPLAP study: a randomized placebo-controlled clinical trial assessing postoperative functional recovery using intraperitoneal local anaesthetic in laparoscopic colorectal surgery.,"AIM


Postoperative pain remains a major factor in recovery from colorectal resection. There is increasing interest in opioid-sparing analgesia, and intraperitoneal local anaesthetic (IPLA) has recently been shown to be useful in minor laparoscopic and open colorectal procedures. The aim of this study was to evaluate the impact of IPLA on functional recovery following major laparoscopic surgery. In this controlled trial, mobility, as measured by the De Morton Mobility Index (DEMMI), was used as a surrogate for postoperative functional recovery.
METHOD


Patients undergoing laparoscopic colorectal resection were randomized either to continuous ropivacaine (0.2% at 4-6 ml/h) or to saline (0.9%) which were administered via intraperitoneal catheter for 3 days postoperatively. Results were analysed in a double-blind manner. DEMMIs were assessed on postoperative days 1, 2, 3, 7 and 30, and data on pain, opioid consumption, gut and respiratory function, length of stay (LOS) and complications were recorded.
RESULTS


Ninety-six patients were recruited. There was no difference in primary outcome (i.e., functional recovery) between IPLA and placebo groups. Opioid consumption and LOS were similar between groups, and no differences were found for any secondary outcome measure. There were no adverse events related to ropivacaine.
CONCLUSION


Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.",2019,"CONCLUSION


Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.","['major laparoscopic surgery', 'Ninety-six patients were recruited', 'laparoscopic colorectal surgery', 'Patients undergoing laparoscopic colorectal resection']","['intraperitoneal local anaesthetic', 'continuous ropivacaine', 'placebo', 'IPLA']","['functional recovery or analgesic consumption', 'Opioid consumption and LOS', 'functional recovery', 'pain, opioid consumption, gut and respiratory function, length of stay (LOS) and complications']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2830173', 'cui_str': 'iPLA(2)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",96.0,0.611913,"CONCLUSION


Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Stephensen', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'McManus', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Carroll', 'Affiliation': 'Department of Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Holz', 'Affiliation': 'Newcastle Anaesthetic and Perioperative Service, Newcastle, New South Wales, Australia.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14720']
3256,31927662,Assessing the health impact of interventions for baker's allergy and asthma in supermarket bakeries: a group randomised trial.,"PURPOSE


To assess the impact of an intervention for baker's allergy and asthma in supermarket bakeries.
METHODS


A group randomised trial conducted in 31 bakeries (n = 337 bakers) that were randomly assigned to one of two intervention groups (n = 244 bakers) and a control group (n = 93 bakers). Health data collected prior to and 1-year after the intervention included information obtained from an ECRHS questionnaire; tests for atopy and serum-specific IgE to cereal flours; fractional exhaled nitric oxide (FeNO). Data from the two intervention groups were combined to form one intervention group for purposes of the statistical analysis.
RESULTS


At 1 year of follow-up, the incidence and level of decline of work-related ocular-nasal and chest symptoms, sensitisation status and elevated FeNO (FeNO > 25 ppb) was similar in both intervention and control groups. The mean FeNO difference was also similar across both groups (2.2 ppb vs 1.7 ppb, p = 0.86). In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24). Multivariate logistic regression models (adjusting for smoking, baseline sensitisation to cereal flour, baseline FeNO > 25 ppb) did not demonstrate an appreciable FeNO decline (≥ 10%) in the intervention compared to control group. However, stratification by the presence of work-related ocular-nasal symptoms in bakers at baseline demonstrated a significant FeNO decline (≥ 10%) in the intervention compared to the control group (OR 3.73, CI 1.22-11.42).
CONCLUSION


This study demonstrates some evidence of an intervention effect on FeNO 1 year after an intervention, particularly in bakers with work-related ocular-nasal symptoms.",2020,"In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24).","['31 bakeries (n\u2009=\u2009337 bakers', ""baker's allergy and asthma in supermarket bakeries"", 'bakers with work-related ocular-nasal symptoms']",[],"['incidence and level of decline of work-related ocular-nasal and chest symptoms, sensitisation status and elevated FeNO', 'mean FeNO difference', 'FeNO decline']","[{'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0629616,"In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24).","[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Al Badri', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Baatjies', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Jeebhay', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa. Mohamed.Jeebhay@uct.ac.za.'}]",International archives of occupational and environmental health,['10.1007/s00420-019-01511-7']
3257,31937907,Impact of intermittent vs. continuous energy restriction on weight and cardiometabolic factors: a 12-month follow-up.,"BACKGROUND AND OBJECTIVE


Intermittent energy restriction continues to gain popularity as a weight loss strategy; however, data assessing it's long-term viability is limited. The objective of this study was to follow up with participants 12 months after they had completed a 12-month dietary intervention trial involving continuous energy restriction and two forms of intermittent energy restriction; a week-on-week-off energy restriction and a 5:2 programme, assessing long-term changes on weight, body composition, blood lipids and glucose.
SUBJECTS AND METHODS


109 overweight and obese adults, aged 18-72 years, attended a 12-month follow-up after completing a 12-month dietary intervention involving three groups: continuous energy restriction (1000 kcal/day for women and 1200 kcal/day for men), week-on-week-off energy restriction (alternating between the same energy restriction as the continuous group for one week and one week of habitual diet), or 5:2 (500 kcal/day on modified fast days each week for women and 600 kcal/day for men). The primary outcome was weight change at 24 months from baseline, with secondary outcomes of change in body composition, blood lipids and glucose.
RESULTS


For the 109 individuals who completed the 12-month follow-up (82 female, 15 male, mean BMI 33 kg/m 2 ), weight decreased over time with no differences between week-on and week-off and continuous energy restriction or 5:2 and continuous energy restriction with -4.5 ± 4.9 kg for continuous energy restriction, -2.8 ± 6.5 kg for week-on, week-off and -3.5 ± 5.1 kg for 5:2. Total cholesterol reduced over time and glucose, HDL, LDL and triglycerides were unchanged.
DISCUSSION AND CONCLUSION


Intermittent energy restriction was as successful in achieving modest weight loss over a 24-month period as continuous energy restriction.",2020,"Total cholesterol reduced over time and glucose, HDL, LDL and triglycerides were unchanged.
","['participants 12 months after they had completed a 12-month dietary intervention trial involving', '109 individuals who completed the 12-month follow-up (82 female, 15 male, mean BMI 33\u2009kg/m 2 ), weight decreased over time with no differences between week-on and week-off and continuous energy restriction or 5:2 and continuous energy restriction with -4.5\u2009±\u20094.9\u2009kg for continuous energy restriction, -2.8\u2009±\u20096.5\u2009kg for week-on, week-off and -3.5\u2009±\u20095.1\u2009kg for 5:2', '109 overweight and obese adults, aged 18-72 years, attended a 12-month follow-up after completing a 12-month dietary intervention involving three groups']","['continuous energy restriction', 'intermittent vs. continuous energy restriction', 'continuous energy restriction and two forms of intermittent energy restriction']","['weight loss', 'Total cholesterol reduced over time and glucose, HDL, LDL and triglycerides', 'body composition, blood lipids and glucose', 'weight change', 'weight, body composition, blood lipids and glucose', 'weight and cardiometabolic factors']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",82.0,0.0154023,"Total cholesterol reduced over time and glucose, HDL, LDL and triglycerides were unchanged.
","[{'ForeName': 'Michelle Louise', 'Initials': 'ML', 'LastName': 'Headland', 'Affiliation': 'School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Peter Marshall', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Jennifer Beatrice', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, SA, Australia. jennifer.keogh@unisa.edu.au.'}]",International journal of obesity (2005),['10.1038/s41366-020-0525-7']
3258,31965573,Phlebotomy resulting in controlled hypovolaemia to prevent blood loss in major hepatic resections (PRICE-1): a pilot randomized clinical trial for feasibility.,"BACKGROUND


Major liver resection is associated with blood loss and transfusion. Observational data suggest that hypovolaemic phlebotomy can reduce these risks. This feasibility RCT compared hypovolaemic phlebotomy with the standard of care, to inform a future multicentre trial.
METHODS


Patients undergoing major liver resections were enrolled between June 2016 and January 2018. Randomization was done during surgery and the surgeons were blinded to the group allocation. For hypovolaemic phlebotomy, 7-10 ml per kg whole blood was removed, without intravenous fluid replacement. Co-primary outcomes were feasibility and estimated blood loss (EBL).
RESULTS


A total of 62 patients were randomized to hypovolaemic phlebotomy (31) or standard care (31), at a rate of 3·1 patients per month, thus meeting the co-primary feasibility endpoint. The median EBL difference was -111 ml (P = 0·456). Among patients at high risk of transfusion, the median EBL difference was -448 ml (P = 0·069). Secondary feasibility endpoints were met: enrolment, blinding and target phlebotomy (mean(s.d.) 7·6(1·9) ml per kg). Blinded surgeons perceived that parenchymal resection was easier with hypovolaemic phlebotomy than standard care (16 of 31 versus 10 of 31 respectively), and guessed that hypovolaemic phlebotomy was being used with an accuracy of 65 per cent (20 of 31). There was no significant difference in overall complications (10 of 31 versus 15 of 31 patients), major complications or transfusion. Among those at high risk, transfusion was required in two of 15 versus three of nine patients (P = 0·326).
CONCLUSION


Endpoints were met successfully, but no difference in EBL was found in this feasibility study. A multicentre trial (PRICE-2) powered to identify a difference in perioperative blood transfusion is justified. Registration number: NCT02548910 ( http://www.clinicaltrials.gov).",2020,"There was no significant difference in overall complications (10 of 31 versus 15 of 31 patients), major complications or transfusion.","['major hepatic resections (PRICE-1', '62 patients', 'Patients undergoing major liver resections were enrolled between June 2016 and January 2018']","['hypovolaemic phlebotomy (31) or standard care', 'hypovolaemic phlebotomy', '7·6(1·9', 'Phlebotomy resulting in controlled hypovolaemia']","['major complications or transfusion', 'median EBL difference', 'feasibility and estimated blood loss (EBL', 'EBL', 'enrolment, blinding and target phlebotomy (mean(s.d', 'blood loss', 'overall complications']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",62.0,0.366431,"There was no significant difference in overall complications (10 of 31 versus 15 of 31 patients), major complications or transfusion.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Martel', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Baker', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wherrett', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Saidenberg', 'Affiliation': 'Department of Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Workneh', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saeed', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gadbois', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McVicar', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rao', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abou Khalil', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Bertens', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'F K', 'Initials': 'FK', 'LastName': 'Balaa', 'Affiliation': 'Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}]",The British journal of surgery,['10.1002/bjs.11463']
3259,31960448,"Effect of short-term vitamin D supplementation after nonsurgical periodontal treatment: A randomized, double-masked, placebo-controlled clinical trial.","OBJECTIVES


This trial aimed to evaluate the efficacy and safety of vitamin D supplementation on the residual moderate and deep pockets following nonsurgical periodontal therapy.
BACKGROUND


Vitamin D supplementation has potential effects on periodontitis, but current evidence remains inconclusive.
METHODS


After 3 months of nonsurgical periodontal treatment, 360 patients with moderate or severe periodontitis were randomly assigned to 2000 international unit (IU)/d vitamin D3, 1000 IU/d vitamin D3, or placebo. Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
RESULTS


There was a slight but significant decrease in AL and PD in both vitamin D groups compared with placebo group for moderate and deep pockets. About 2000 IU/d vitamin D3 group, 1000 IU/d vitamin D3 group, and placebo group all decreased the AL for both moderate pockets (-0.4 mm vs -0.4 mm vs -0.3 mm) and deep pockets (-1.1 mm vs -1.1 mm vs -1.0 mm) (all P < .05). Similarly, PD was also decreased in these three groups for both moderate pockets and deep pockets (all P < .05). In addition, vitamin D supplementation was well tolerated, and no adverse events were reported.
CONCLUSIONS


Although statistically significant differences were observed in favor to vitamin D supplementation, the magnitude of effect size tended to be modest with limited clinical relevance and the long-term efficacy and safety warrant further investigation.",2020,"Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
",['360 patients with moderate or severe periodontitis'],"['IU/d vitamin D3', '2000 international unit (IU)/d vitamin D3, 1000\xa0IU/d vitamin D3, or placebo', 'Vitamin D supplementation', 'short-term vitamin D supplementation', 'placebo', 'vitamin D3', 'vitamin D supplementation']","['tolerated, and no adverse events', 'probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH', 'AL and PD', 'deep pockets']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2948667', 'cui_str': 'Crest'}]",360.0,0.430091,"Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
","[{'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Zuomin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}]",Journal of periodontal research,['10.1111/jre.12719']